,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342846,Impact of Intermittent Mass Testing and Treatment on Incidence of Malaria Infection in a High Transmission Area of Western Kenya.,"Progress with malaria control in western Kenya has stagnated since 2007. Additional interventions to reduce the high burden of malaria in this region are urgently needed. We conducted a two-arm, community-based, cluster-randomized, controlled trial of active case detection and treatment of malaria infections in all residents mass testing and treatment (MTaT) of 10 village clusters (intervention clusters) for two consecutive years to measure differences in the incidence of clinical malaria disease and malaria infections compared with 20 control clusters where MTaT was not implemented. All residents of intervention clusters, irrespective of history of fever or other malaria-related symptoms, were tested three times per year before the peak malaria season using malaria rapid diagnostic tests. All positive cases were treated with dihydroartemisinin-piperaquine. The incidence of clinical malaria was measured through passive surveillance, whereas the cumulative incidence of malaria infection was measured using active surveillance in a cohort comprising randomly selected residents. The incidence of clinical malaria was 0.19 cases/person-year (p-y, 95% CI: 0.13-0.28) in the intervention arm and 0.24 cases/p-y (95% CI: 0.15-0.39) in the control arm (incidence rate ratio [IRR] 0.79, 95% CI: 0.61-1.02). The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04). Six rounds of MTaT over 2 years did not have a significant impact on the incidence of clinical malaria or the cumulative incidence of malaria infection in this area of high malaria transmission.",2020,"The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04).","['All residents of intervention clusters, irrespective of history of fever or other malaria-related symptoms', 'in a High Transmission Area of Western Kenya']",['dihydroartemisinin-piperaquine'],"['incidence of clinical malaria or the cumulative incidence of malaria infection', 'incidence rate ratio [IRR', 'Incidence of Malaria Infection', 'incidence of clinical malaria', 'cumulative incidence of malaria infection', 'cumulative incidence of malaria infections', 'incidence of clinical malaria disease and malaria infections']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.204021,"The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04).","[{'ForeName': 'Meghna R', 'Initials': 'MR', 'LastName': 'Desai', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Samuels', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Wycliffe', 'Initials': 'W', 'LastName': 'Odongo', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Nobert Awino', 'Initials': 'NA', 'LastName': 'Odero', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Kephas', 'Initials': 'K', 'LastName': 'Otieno', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Ya Ping', 'Initials': 'YP', 'LastName': 'Shi', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Stephen Patrick', 'Initials': 'SP', 'LastName': 'Kachur', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Hamel', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Lindblade', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0735']
1,32342848,Safety and Immunogenicity of an AS03 B -Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study.,"Dengue disease and its causative agents, the dengue viruses (DENV-1-4), cause high morbidity in tropical and subtropical regions. We evaluated three dosing regimens of the investigational tetravalent AS03 B -adjuvanted dengue-purified inactivated vaccine (DPIV+AS03 B ). In this phase 1/2, observer-blind, placebo-controlled study (NCT02421367), 140 healthy adults were randomized 1:1:2 to receive DPIV+AS03 B  according to the following regimens: 0-1 month (M), 0-1-6 M, or 0-3 M. Participants received DPIV+AS03 B  or placebo at M0, M1, M3, and M6 according to their dosing schedule. Primary objectives were 1) to evaluate the safety of DPIV+AS03 B  for 28 days (D) after each dose; 2) to demonstrate the added value of a booster dose (0-1-6 M versus 0-1 M) based on neutralizing antibody titers to each DENV type (DENV-1-4) at 28 D after the last dose; and, if this objective was met, 3) to demonstrate the benefit of a longer interval between the first and second doses (0-1 M versus 0-3 M). Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV+AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV+AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups. Within 28 D following each dose, the frequency of unsolicited AEs after DPIV+AS03 B  appeared higher for three-dose (0-1-6 M) than two-dose (0-1 M and 0-3 M) regimens. No serious AEs were considered related to vaccination, and no potential immune-mediated diseases were reported during the study. All three schedules were well tolerated. Both primary immunogenicity objectives were demonstrated. The 0-3 M and 0-1-6 M regimens were more immunogenic than the 0-1 M regimen.",2020,"Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV + AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV + AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups.","['140 healthy adults', 'Healthy U.S. Adults']","['adjuvanted dengue-purified inactivated vaccine (DPIV + AS03 B ', 'DPIV + AS03', 'investigational tetravalent AS03 B', 'AS03 B -Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine', 'DPIV + AS03 B  or placebo at M0, M1, M3, and M6 according to their dosing schedule', 'placebo']","['safety of DPIV + AS03 B  for 28 days (D', 'Adverse events (AEs', 'tolerated', 'Safety and Immunogenicity']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0011315', 'cui_str': 'Dengue virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",140.0,0.149575,"Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV + AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV + AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups.","[{'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lepine', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'McArthur', 'Affiliation': 'Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Currier', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moris', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Keiser', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Paris', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GSK, Rockville, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0738']
2,32343462,Early data on long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2-year update from the open-label extension of the NEURO-TTR trial.,"BACKGROUND AND PURPOSE


Hereditary transthyretin (hATTR) amyloidosis causes progressive polyneuropathy resulting from transthyretin (TTR) amyloid deposition throughout the body, including the peripheral nerves. The efficacy and safety of inotersen, an antisense oligonucleotide inhibitor of TTR protein production, were demonstrated in the pivotal NEURO-TTR study in patients with hATTR polyneuropathy. Here, the long-term efficacy and safety of inotersen are assessed in an ongoing open-label extension (OLE) study.
METHODS


Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004). Efficacy assessments included the modified Neuropathy Impairment Score plus seven neurophysiological tests composite score (mNIS + 7), the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN) questionnaire total score and the Short-Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score. Safety and tolerability were also assessed.
RESULTS


Overall, 97% (135/139) of patients who completed NEURO-TTR enrolled in the OLE. Patients who received inotersen for 39 cumulative months in NEURO-TTR and the OLE continued to show benefit; patients who switched from placebo to inotersen in the OLE demonstrated improvement or stabilization of neurological disease progression by mNIS + 7, Norfolk QOL-DN and SF-36 PCS. No new safety concerns were identified. There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure.
CONCLUSION


Inotersen slowed disease progression and reduced deterioration of quality of life in patients with hATTR polyneuropathy. Early treatment with inotersen resulted in greater long-term disease stabilization than delayed initiation. Routine platelet and renal safety monitoring were effective; no new safety signals were observed.",2020,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure.
","['Patients With Hereditary Transthyretin Amyloidosis', 'Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004', 'patients with hATTR polyneuropathy']","['OLE', 'placebo']","['Safety and tolerability', 'risk for grade 4 thrombocytopenia or severe renal events', 'stabilization of neurologic disease progression by mNIS+7, Norfolk QOL-DN, and SF-36 PCS', 'disease progression and reduced deterioration of quality of life', 'greater long-term disease stabilization', 'modified Neuropathy Impairment Score +7 neurophysiologic tests composite score (mNIS+7), Norfolk Quality of Life-Diabetic Neuropathy questionnaire total score (Norfolk QOL-DN), and the Short Form 36 Health Survey (SF-36) Physical Component Summary score (PCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.0250599,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure.
","[{'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Wang', 'Affiliation': 'University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'CEPARM, Amyloidosis Referral Center, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Plante-Bordeneuve', 'Affiliation': 'CHU Henri Mondor, Creteil, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barroso', 'Affiliation': 'FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Amyloidosis Center, IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'CHULN, Hospital Santa Maria and Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kwoh', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Boston, MA, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Benson', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gertz', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.14285']
3,32338944,Using intraindividual variability as an indicator of cognitive improvement in a physical exercise intervention of older women with mild cognitive impairment.,"OBJECTIVES


Intervention programs designed to improve cognitive ability in older adults with mild cognitive impairment (MCI) have often focused on physical exercise as a means to improve traditional measures of cognition, with mixed success. Individuals with MCI show high levels of intraindividual variability (IIV) in response speed, and IIV may be sensitive to intervention-related changes. The current study evaluated if participants who participated in a physical activity intervention (aerobic or resistance training) showed a reduction in IIV, compared to a balance and tone control group.
METHOD


This study was a secondary analysis of the EXercise for Cognition and Everyday Living (EXCEL) Study. Women Aged 70-80 years with probable MCI ( n  = 86) participated in a 6-month randomized controlled trial designed to investigate the effects of different physical exercises on cognitive ability. Participants completed 1-back, task switching, and spatial working memory tasks at baseline, 13 weeks (midpoint) and upon completion of the program.
RESULTS


Analyses were conducted following both the intent-to-treat principle and complier average casual effect (CACE) modeling. Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models. The intent-to-treat analyses were all nonsignificant.
CONCLUSIONS


Physical exercise resulted in improved IIV in older adults with probable MCI, showing that IIV is modifiable by lifestyle engagement. IIV may be a useful complementary index of cognitive plasticity particularly among those with cognitive impairment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models.,"['Women Aged 70-80 years with probable MCI ( n  = 86', 'older women with mild cognitive impairment', 'older adults with probable MCI', 'older adults with mild cognitive impairment (MCI', 'participants who participated in a']","['physical exercise intervention', 'physical activity intervention (aerobic or resistance training', 'Physical exercise', 'physical exercises', 'balance and tone control group']","['reduced IIV on task switching', '1-back, task switching, and spatial working memory tasks', 'cognitive ability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0449234,Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Brydges', 'Affiliation': 'Department of Human Development and Family Studies.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy.'}, {'ForeName': 'Allison A M', 'Initials': 'AAM', 'LastName': 'Bielak', 'Affiliation': 'Department of Human Development and Family Studies.'}]",Neuropsychology,['10.1037/neu0000638']
4,32340074,The FiCTION trial: Child oral health-related quality of life and dental anxiety across three treatment strategies for managing caries in young children.,"OBJECTIVES


The FiCTION trial compared co-primary outcomes (dental pain and/or infection) and secondary outcomes (child oral health-related quality of life [COHRQOL], child dental anxiety, cost-effectiveness, caries development/progression and acceptability) across three treatment strategies (Conventional with Prevention [C + P]; Biological with Prevention [B + P]; Prevention Alone [PA]) for managing caries in children in primary care. COHRQOL and child dental anxiety experiences are reported upon here.
METHODS


A multi-centre, 3-arm, parallel-group, unblinded patient-randomized controlled trial of 3- to 7-year-olds treated under NHS contracts was conducted in 72 general dental practices in England, Wales and Scotland. Child participants (with at least one primary molar with dentinal caries) were randomized (1:1:1) to one of three treatment arms with the intention of being managed according to allocated arm for 3 years (minimum 23 months). Randomization was via a centrally administered system using random permuted blocks of variable length. At baseline and final visit, accompanying parents/caregivers completed a parental questionnaire including COHRQOL (16 item P-CPQ-16), and at every visit, child- and parental-questionnaire-based data were collected for child-based dental trait and state anxiety. Statistical analyses were conducted on complete cases from the modified intention-to-treat (mITT) analysis set.
RESULTS


A total of 1144 children were randomized (C + P: 386; B + P: 381; PA: 377). The mITT analysis set included the 1058 children who attended at least one study visit (C + P: 352; B + P: 352; PA: 354). Median follow-up was 33.8 months (IQR: 23.8, 36.7). The P-CPQ-16 overall score could be calculated after simple imputation at both baseline and final visit for 560 children (C + P: 189; B + P: 189; PA: 182). There was no evidence of a difference in the estimated adjusted mean P-CPQ-16 at the final visit which was, on average, 0.3 points higher (97.5% CI: -1.1 to 1.6) in B + P than C + P and 0.2 points higher, on average, (97.5% CI: -1.2 to 1.5) in PA than for C + P. Child dental trait anxiety and child dental state anxiety, measured at every treatment visit, showed no evidence of any statistically or clinically significant difference between arms in adjusted mean scores averaged over all follow-up visits.
CONCLUSIONS


The differences noted in COHRQOL and child-based dental trait and dental state anxiety measures across three treatment strategies for managing dental caries in primary teeth were small, and not considered to be clinically meaningful. The findings highlight the importance of including all three strategies in a clinician's armamentarium, to manage childhood caries throughout the young child's life and achieve positive experiences of dental care.",2020,"There was no evidence of a difference in the estimated adjusted mean P-CPQ-16 at the final visit which was, on average, 0.3 points higher (97.5% CI: -1.1 to 1.6) in B + P than C + P and 0.2 points higher, on average, (97.5% CI: -1.2 to 1.5) in PA than for C + P. Child dental trait anxiety and child dental state anxiety, measured at every treatment visit, showed no evidence of any statistically or clinically significant difference between arms in adjusted mean scores averaged over all follow-up visits.
","['young children', '72 general dental practices in England, Wales and Scotland', 'Child participants (with at least one primary molar with dentinal caries', 'children in primary care', '1058 children who attended at least one study visit (C\xa0+\xa0P: 352; B\xa0+\xa0P: 352; PA: 354', '1144 children']","['Prevention [B\xa0+\xa0P]; Prevention Alone [PA', '3- to 7-year-olds treated under NHS contracts']","['P-CPQ-16 overall score', 'Child dental trait anxiety and child dental state anxiety', 'COHRQOL and child-based dental trait and dental state anxiety measures', 'secondary outcomes (child oral health-related quality of life [COHRQOL], child dental anxiety, cost-effectiveness, caries development/progression and acceptability']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0017318', 'cui_str': 'General dental practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",1144.0,0.131323,"There was no evidence of a difference in the estimated adjusted mean P-CPQ-16 at the final visit which was, on average, 0.3 points higher (97.5% CI: -1.1 to 1.6) in B + P than C + P and 0.2 points higher, on average, (97.5% CI: -1.2 to 1.5) in PA than for C + P. Child dental trait anxiety and child dental state anxiety, measured at every treatment visit, showed no evidence of any statistically or clinically significant difference between arms in adjusted mean scores averaged over all follow-up visits.
","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nicola P T', 'Initials': 'NPT', 'LastName': 'Innes', 'Affiliation': 'Dental School & Hospital, University of Dundee, Dundee, UK.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Marshman', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'Dental School & Hospital, University of Dundee, Dundee, UK.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Abouhajar', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Chadwick', 'Affiliation': 'School of Dentistry, College of Biomedical & Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Deery', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ferranti', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Institute of Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Gail V A', 'Initials': 'GVA', 'LastName': 'Douglas', 'Affiliation': 'School of Dentistry, University of Leeds, Leeds, UK.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12537']
5,32348624,Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial.,"OBJECTIVES


To evaluate through computer software analysis, the efficacy of the use of a plaque disclosing agent as a visual guide for biofilm removal during professional mechanical plaque removal in terms of post-treatment residual plaque area (RPA).
METHODS


Thirty-two healthy patients were selected and randomized in two groups to receive a session of professional mechanical plaque removal with air-polishing followed by ultrasonic instrumentation with (Guided Biofilm therapy-GBT) or without (Control) the preliminary application of a plaque disclosing agent as visual guide. The residual plaque area (RPA) was evaluated through re-application of the disclosing agent and computer software analysis, considering the overall tooth surface and the gingival and coronal portions separately.
RESULTS


A statistically and clinically significant difference between treatments is observed, with GBT achieving an RPA of 6.1% (4.1-9.1) vs 12.0% (8.2-17.3) of the Control on the Gingival surface and of 3.5% (2.3-5.2) vs 9.0% (6-13.1) on the Coronal, with a proportional reduction going from 49.2% (P-value = .018) on the former surface to more than 60% (P-value = .002) on the latter.
CONCLUSION


The application of a plaque disclosing agent to guide plaque removal seems to lead to better biofilm removal.",2020,"A statistically and clinically significant difference between treatments is observed, with GBT achieving an RPA of 6.1% (4.1-9.1) versus 12.0% (8.2-17.3) of the Control on the Gingival surface and of 3.5% (2.3-5.2) versus 9.0% (6-13.1) on the Coronal, with a proportional reduction going from 49.2% (p-value= 0.018) on the former surface to more than 60% (p-value = 0.002) on the latter.
",['32 healthy patients'],['professional mechanical plaque removal with air-polishing followed by ultrasonic instrumentation with (Guided Biofilm therapy - GBT) or without (Control) the preliminary application of a plaque disclosing agent as visual guide'],"['Gingival surface', 'Residual Plaque Area (RPA', 'GBT achieving an RPA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",32.0,0.025827,"A statistically and clinically significant difference between treatments is observed, with GBT achieving an RPA of 6.1% (4.1-9.1) versus 12.0% (8.2-17.3) of the Control on the Gingival surface and of 3.5% (2.3-5.2) versus 9.0% (6-13.1) on the Coronal, with a proportional reduction going from 49.2% (p-value= 0.018) on the former surface to more than 60% (p-value = 0.002) on the latter.
","[{'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Mensi', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Sordillo', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Agosti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.'}]",International journal of dental hygiene,['10.1111/idh.12442']
6,32340738,"The Effect of Soft Tissue Injury Cold Application Duration on Symptoms, Edema, Joint Mobility, and Patient Satisfaction: A Randomized Controlled Trial.","INTRODUCTION


The aim of this study was to determine the effect of cold application time on symptoms, edema, and patient satisfaction in soft tissue injuries.
METHODS


A randomized controlled trial was conducted with 105 patients who were treated with cold applications of different durations (10, 20, and 30 minutes). Interview-assisted data were collected on symptoms and patient satisfaction. Edema and range of motion were objectively measured in patients with an ankle injury. Data were analyzed using repeated-measures analysis of variance.
RESULTS


Pain reduction was greatest in the 20 minutes of cold application group (F = 46.35, P < 0.05). Symptoms of discomfort such as tingling (F = 65.93, P < 0.05), redness (F = 61.95, P < 0.05), itching (F = 36.49, P < 0.05), numbness (F = 57.94, P < 0.05), and burning (F = 55.40, P < 0.05) were more frequent in the group with 30 minutes of cold application. Both joint mobility (F = 45.28, P < 0.05) and patient satisfaction (F = 130.99, P < 0.05) were the highest in the group with 20 minutes of cold application.
DISCUSSION


Our findings suggest that a duration of 20 minutes for cold application for a soft tissue ankle injury is recommended to maximize pain control, joint mobility, and patient satisfaction while decreasing other symptoms of discomfort.",2020,"Both joint mobility (F = 45,283, P < 0.05) and patient satisfaction (F = 130,987, P < 0.05) were the highest in the group with 20 minutes of cold application.
","['105 patients who were treated with cold applications of\xa0different durations (10, 20, and 30\xa0minutes', 'patients with an ankle injury']",['Soft Tissue Injury Cold Application Duration'],"['Edema and range of motion', 'joint mobility', 'Symptoms, Edema, Joint Mobility, and Patient Satisfaction', 'numbness', 'patient satisfaction', 'Symptoms of discomfort such as tingling', 'itching', 'symptoms, edema, and patient satisfaction', 'Pain reduction', 'redness']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}]","[{'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",,0.111752,"Both joint mobility (F = 45,283, P < 0.05) and patient satisfaction (F = 130,987, P < 0.05) were the highest in the group with 20 minutes of cold application.
","[{'ForeName': 'Senan', 'Initials': 'S', 'LastName': 'Mutlu', 'Affiliation': ''}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.02.017']
7,32342255,Combined aspirin and clopidogrel therapy in phacoemulsification cataract surgery: a risk factor for ocular hemorrhage?,"PURPOSE


To evaluate the safety of phacoemulsification cataract surgery in the patients undergoing dual antiplatelet therapy with aspirin and clopidogrel.
METHODS


Consecutive patients undergoing phacoemulsification cataract surgery with a clear corneal incision under topical anesthesia were eligible for inclusion in the study. Thirty-eight eyes from 38 patients on combined aspirin and clopidogrel therapy who continued the treatment were classified into the maintenance group, a matched group of 38 eyes from 38 patients on no antiplatelet/anticoagulant therapy as the control group. The best-corrected visual acuity (BCVA) and incidences of complications were compared between the two groups.
RESULTS


There was no significant difference in final BCVA between the maintenance group and the control group (p = 0.178). No significant difference existed in the incidences of hemorrhagic or non-hemorrhagic complications between the two groups (p = 0.529 and p = 0.589, respectively). Moreover, no surgery was postponed or cancelled due to hemorrhagic complications in either group, and no cardiovascular events occurred during the follow-up. There was no case of anterior chamber hemorrhage, vitreous hemorrhage, or suprachoroidal hemorrhage.
CONCLUSIONS


Our outcomes indicated that phacoemulsification cataract surgery using a clear corneal incision with topical anesthesia could be safely done without stopping dual antiplatelet therapy with aspirin and clopidogrel.",2020,There was no significant difference in final BCVA between the maintenance group and the control group (p = 0.178).,"['Consecutive patients undergoing phacoemulsification cataract surgery with a clear corneal incision under topical anesthesia were eligible for inclusion in the study', 'Thirty-eight eyes from 38 patients on combined aspirin and clopidogrel therapy who continued the treatment were classified into the maintenance group, a matched group of 38 eyes from 38 patients on', 'patients undergoing dual antiplatelet therapy with', 'phacoemulsification cataract surgery']","['aspirin and clopidogrel', 'aspirin and clopidogrel therapy', 'no antiplatelet/anticoagulant therapy', 'phacoemulsification cataract surgery']","['best-corrected visual acuity (BCVA) and incidences of complications', 'incidences of hemorrhagic or non-hemorrhagic complications', 'hemorrhagic complications', 'cardiovascular events', 'anterior chamber hemorrhage, vitreous hemorrhage, or suprachoroidal hemorrhage', 'final BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1827493', 'cui_str': 'Clear corneal incision'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C1644185', 'cui_str': 'Suprachoroidal hemorrhage'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",38.0,0.0171148,There was no significant difference in final BCVA between the maintenance group and the control group (p = 0.178).,"[{'ForeName': 'Qingjian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Eye Institute of Xiamen University, School of Medicine, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Xuzhong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Shaopan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Eye Institute of Xiamen University, School of Medicine, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': 'Eye Institute of Xiamen University, School of Medicine, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Yan', 'Affiliation': 'Eye Institute of Xiamen University, School of Medicine, Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Shanghai Gonghui Hospital, No. 6, Lane 315, Shimen Road (No. 1), Shanghai, 200040, China. zhangpei7607@163.com.'}, {'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Shanghai, 200040, China. ophwzl@163.com.'}]",International ophthalmology,['10.1007/s10792-020-01378-5']
8,32346886,Predictors of genetic testing uptake in newly diagnosed breast cancer patients.,"BACKGROUND AND OBJECTIVES


Many newly diagnosed breast cancer patients do not receive genetic counseling and testing at the time of diagnosis. We examined predictors of genetic testing (GT) in this population.
METHODS


Within a randomized controlled trial of proactive rapid genetic counseling and testing vs usual care, patients completed a baseline survey within 6 weeks of breast cancer diagnosis but before a definitive survey. We conducted a multinomial logistic regression to identify predictors of GT timing/uptake.
RESULTS


Having discussed GT with a surgeon was a dominant predictor (χ 2  (2, N = 320) = 70.13; P < .0001). Among those who discussed GT with a surgeon, patients who had made a final surgery decision were less likely to receive GT before surgery compared with postsurgically (OR [odds ratio] = 0.24; 95% confidence interval [CI] = 0.12-0.49) or no testing (OR = 0.28; 95% CI = 0.14-0.56). Older patients (OR = 0.95; 95% CI = 0.91-0.99) and participants enrolled in New York/New Jersey (OR = 0.22; 95% CI = 0.07-0.72) were less likely to be tested compared with receiving results before surgery. Those with higher perceived risk (OR = 1.02; 95% CI = 1.00-1.03) were more likely to receive results before surgery than to not be tested.
CONCLUSIONS


This study highlights the role of patient-physician communication about GT as well as patient-level factors that predict presurgical GT.",2020,"Those with higher perceived risk (OR = 1.02; 95% CI = 1.00-1.03) were more likely to receive results before surgery than to not be tested.
",['newly diagnosed breast cancer patients'],"['proactive rapid genetic counseling and testing vs usual care', 'genetic testing (GT']",['final surgery decision'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.139548,"Those with higher perceived risk (OR = 1.02; 95% CI = 1.00-1.03) were more likely to receive results before surgery than to not be tested.
","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Ladd', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Beth N', 'Initials': 'BN', 'LastName': 'Peshkin', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Hooker', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Willey', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Heiddis', 'Initials': 'H', 'LastName': 'Valdimarsdottir', 'Affiliation': 'Department of Population Health Science and Policy, Center for Behavioral Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tiffani', 'Initials': 'T', 'LastName': 'DeMarco', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': ""O'Neill"", 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Binion', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Schwartz', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of surgical oncology,['10.1002/jso.25956']
9,32343963,Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial.,"BACKGROUND


Noninvasive ventilation (NIV) is an effective form of treatment in obesity hypoventilation syndrome (OHS) with severe OSA. However, there is paucity of evidence in patients with OHS without severe OSA phenotype.
RESEARCH QUESTION


Is NIV effective in OHS without severe OSA phenotype?
STUDY DESIGN AND METHODS


In this multicenter, open-label parallel group clinical trial performed at 16 sites in Spain, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnea-hypopnea index < 30 events/h (ie, no severe OSA) to NIV or lifestyle modification (control group) using simple randomization through an electronic database. The primary end point was hospitalization days per year. Secondary end points included other hospital resource utilization, incident cardiovascular events, mortality, respiratory functional tests, BP, quality of life, sleepiness, and other clinical symptoms. Both investigators and patients were aware of the treatment allocation; however, treating physicians from the routine care team were not aware of patients' enrollment in the clinical trial. The study was stopped early in its eighth year because of difficulty identifying patients with OHS without severe OSA. The analysis was performed according to intention-to-treat and per-protocol principles and by adherence subgroups.
RESULTS


Forty-nine patients in the NIV group and 49 in the control group were randomized, and 48 patients in each group were analyzed. During a median follow-up of 4.98 years (interquartile range, 2.98-6.62), the mean hospitalization days per year ± SD was 2.60 ± 5.31 in the control group and 2.71 ± 4.52 in the NIV group (adjusted rate ratio, 1.07; 95% CI, 0.44-2.59; P = .882). NIV therapy, in contrast with the control group, produced significant longitudinal improvement in Paco 2 , pH, bicarbonate, quality of life (Medical Outcome Survey Short Form 36 physical component), and daytime sleepiness. Moreover, per-protocol analysis showed a statistically significant difference for the time until the first ED visit favoring NIV. In the subgroup with high NIV adherence, the time until the first event of hospital admission, ED visit, and mortality was longer than in the low adherence subgroup. Adverse events were similar between arms.
INTERPRETATION


In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days per year. A more intensive program aimed at improving NIV adherence may lead to better outcomes. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT01405976; URL: www.clinicaltrials.gov.",2020,"NIV therapy, in contrast to control group, produced significant longitudinal improvement in PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness.","['49 patients in the NIV group and 49 in the control group were randomized and 48 patients in each group were analyzed', '98 stable ambulatory patients with untreated OHS and apnea-hypopnea index <30 events/hour (i.e., no severe OSA) to', 'obesity hypoventilation syndrome (OHS) with severe obstructive sleep apnea (OSA', 'Obesity Hypoventilation Syndrome without Severe Obstructive Sleep Apnea', 'stable ambulatory patients with OHS without severe OSA', 'OHS patients without severe OSA phenotype']","['Long-term Noninvasive Ventilation', 'Noninvasive ventilation (NIV', 'NIV or lifestyle modification (control group) using simple randomization through an electronic database']","['hospitalization days/year', 'PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness', 'hospital resource utilization, incident cardiovascular events, mortality, respiratory functional tests, blood pressure, quality of life, sleepiness and other clinical symptoms', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0031880', 'cui_str': 'Extreme obesity with alveolar hypoventilation'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0556972', 'cui_str': 'days/year'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",98.0,0.143898,"NIV therapy, in contrast to control group, produced significant longitudinal improvement in PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness.","[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain. Electronic address: fmasa@separ.es.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Maria Á', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain; Respiratory Department, Virgen del Puerto Hospital, Plasencia, Cáceres, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Gomez de Terreros', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero-Eraso', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, University Hospital, Burgos, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, University Hospital, Burgos, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gomez-Garcia', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, IIS Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Miguel Servet Hospital, Zaragoza, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': ""CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Doce de Octubre Hospital, Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Alava University Hospital IRB, Vitoria, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain; Nursing Department, Extremadura University, Cáceres, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Department of Medicine/Pulmonary and Critical Care, University of Chicago, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.03.068']
10,32345286,"Effect of guided counseling on nutritional status of pregnant women in West Gojjam zone, Ethiopia: a cluster-randomized controlled trial.","BACKGROUND


Undernutrition during pregnancy affects birth outcomes adversely. In Ethiopia, despite nutrition counseling on the maternal diet being given by the health workers during pregnancy, maternal undernutrition is still high in the country. Hence, this study aimed to assess the effect of guided counseling using the health belief model and the theory of planned behavior on the nutritional status of pregnant women.
METHODS


A two-arm parallel cluster randomized controlled community trial was conducted in West Gojjam Zone, Ethiopia, from May 1, 2018, to April 30, 2019. The nutritional status of the women was assessed using mid-upper arm circumference. A total of 694 pregnant women were recruited from the intervention (n=346 ) and control (n=348) clusters. Of which endline data were collected from 313 and 332 pregnant women in the intervention and control clusters, respectively. The intervention was started before 16 weeks of gestation and pregnant women in the intervention group attended 4 counseling sessions. Counseling was given at the participants' homes using a counseling guide with the core contents of the intervention. Leaflets with appropriate pictures and the core messages were given for women in the intervention arm. Women in the control group got the routine nutrition education given by the health care system. Data were collected using interviewer administered structured questionnaires and mid-upper arm circumference was measured using an adult MUAC tape. Descriptive statistics  and linear mixed-effects model were used to assess the intervention effect after adjusting for potential confounders.
RESULTS


After the intervention, the prevalence of undernutrition was 16.7% lower in the intervention group compared with the control arm (30.6% Vs 47.3%, P = < 0.001). Women in the intervention group showed significant improvement in nutritional status at the end of the trial than the control group (β = 0.615, p = < 0.001).
CONCLUSION


This study demonstrated that guided counseling using the health belief model and the theory of planned behavior was effective in improving the nutritional status of pregnant women. The results imply the need for the design of model and theory based nutrition counseling guidelines. The trial was registered in Clinical Trials.gov (NCT03627156).",2020,"After the intervention, the prevalence of undernutrition was 16.7% lower in the intervention group compared with the control arm (30.6% Vs 47.3%, P = < 0.001).","['pregnant women in West Gojjam zone, Ethiopia', '313 and 332 pregnant women in the intervention and control clusters, respectively', '694 pregnant women were recruited from the intervention (n=346\xa0) and control (n=348) clusters', 'A two-arm parallel cluster randomized controlled community trial was conducted in West Gojjam Zone, Ethiopia, from May 1, 2018, to April 30, 2019', 'pregnant women']","['routine nutrition education', 'gestation\xa0and pregnant women\xa0in the intervention group attended 4 counseling sessions', 'guided counseling']","['prevalence of undernutrition', 'nutritional status']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",694.0,0.0462763,"After the intervention, the prevalence of undernutrition was 16.7% lower in the intervention group compared with the control arm (30.6% Vs 47.3%, P = < 0.001).","[{'ForeName': 'Yeshalem Mulugeta', 'Initials': 'YM', 'LastName': 'Demilew', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, P.O. Box 79, Bahir Dar, Ethiopia. yeshalem_mulugeta@yahoo.com.'}, {'ForeName': 'Getu Degu', 'Initials': 'GD', 'LastName': 'Alene', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, P.O. Box 79, Bahir Dar, Ethiopia.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Public Health, Jimma University, P.O. Box 378, Jimma, Ethiopia.'}]",Nutrition journal,['10.1186/s12937-020-00536-w']
11,32345685,A Triadic Intervention for Adolescent Sexual Health: A Randomized Clinical Trial.,"OBJECTIVES


In this study, we evaluate the efficacy of Families Talking Together (FTT), a triadic intervention to reduce adolescent sexual risk behavior.
METHODS


Adolescents aged 11 to 14 and their female caregivers were recruited from a pediatric clinic; 900 families were enrolled; 84 declined. Families were randomly assigned to FTT or 1 of 2 control conditions. The FTT triadic intervention consisted of a 45-minute face-to-face session for mothers, health care provider endorsement of intervention content, printed materials for families, and a booster call for mothers. The primary outcomes were ever having had vaginal intercourse, sexual debut within the past 12 months, and condom use at last sexual intercourse. Assessments occurred at baseline, 3 months post baseline, and 12 months post baseline.
RESULTS


Of enrolled families, 73.4% identified as Hispanic, 20.4% as African American, and 6.2% as mixed race. Mean maternal age was 38.8 years, and mean adolescent grade was seventh grade. At the 12-month follow-up, 5.2% of adolescents in the experimental group reported having had sexual intercourse, compared with 18% of adolescents in the control groups ( P  < .05). In the experimental group, 4.7% of adolescents reported sexual debut within the past 12 months, compared with 14.7% of adolescents in the control group ( P  < .05). In the experimental group, 74.2% of sexually active adolescents indicated using a condom at last sexual intercourse, compared with 49.1% of adolescents in the control group ( P  < .05).
CONCLUSIONS


This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.",2020,This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.,"['Mean maternal age was 38.8 years, and mean adolescent grade was seventh grade', 'Adolescent Sexual Health', 'Of enrolled families, 73.4% identified as Hispanic, 20.4% as African American, and 6.2% as mixed race', 'Adolescents aged 11 to 14 and their female caregivers were recruited from a pediatric clinic; 900 families were enrolled; 84 declined', 'adolescents']","['FTT triadic intervention', 'FTT', 'triadic intervention', 'Triadic Intervention', 'Families Talking Together']","['sexual intercourse', 'sexual debut', 'ever having had vaginal intercourse, sexual debut within the past 12 months, and condom use at last sexual intercourse', 'sexual risk behavior']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",900.0,0.0590979,This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Guilamo-Ramos', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York; vincent.ramos@nyu.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Benzekri', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Thimm-Kaiser', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dittus', 'Affiliation': 'Division of Sexually Transmitted Disease Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Yumary', 'Initials': 'Y', 'LastName': 'Ruiz', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Cleland', 'Affiliation': 'New York University Langone Health, New York, New York; and.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'McCoy', 'Affiliation': 'Morris Heights Health Center, Bronx, New York.'}]",Pediatrics,['10.1542/peds.2019-2808']
12,32345990,Effects of β 2 -receptor stimulation by indacaterol in chronic heart failure treated with selective or non-selective β-blockers: a randomized trial.,"Alveolar β 2 -receptor blockade worsens lung diffusion in heart failure (HF). This effect could be mitigated by stimulating alveolar β 2 -receptors. We investigated the safety and the effects of indacaterol on lung diffusion, lung mechanics, sleep respiratory behavior, cardiac rhythm, welfare, and exercise performance in HF patients treated with a selective (bisoprolol) or a non-selective (carvedilol) β-blocker. Study procedures were performed before and after indacaterol and placebo treatments according to a cross-over, randomized, double-blind protocol in forty-four patients (27 on bisoprolol and 17 on carvedilol). No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2  slope and lower maximal P ET CO 2  during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2  31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2  36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively). In carvedilol, indacaterol was associated with a higher peak heart rate (119 ± 34 vs. 113 ± 30 bpm, with indacaterol and placebo) and a lower prevalence of hypopnea during sleep (3.8 [0.0;6.3] vs. 5.8 [2.9;10.5] events/hour, with indacaterol and placebo). Inhaled indacaterol is well tolerated in HF patients, it does not influence lung diffusion, and, in bisoprolol, it increases ventilation response to exercise.",2020,"No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2  slope and lower maximal P ET CO 2  during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2  31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2  36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively).","['forty-four patients (27 on bisoprolol and 17 on', 'chronic heart failure treated with selective or non-selective β-blockers', 'heart failure (HF', 'HF patients treated with a', 'HF patients']","['carvedilol', 'Inhaled indacaterol', 'indacaterol', 'indacaterol and placebo', 'carvedilol, indacaterol', 'selective (bisoprolol) or a non-selective (carvedilol) β-blocker', 'placebo']","['peak heart rate', 'lung diffusion, lung mechanics, sleep respiratory behavior, cardiac rhythm, welfare, and exercise performance', 'hypopnea during sleep']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",,0.162873,"No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2  slope and lower maximal P ET CO 2  during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2  31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2  36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively).","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Contini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Spadafora', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Barbieri', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gugliandolo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Salvioni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Magini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Apostolo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Palermo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Alimento', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Piergiuseppe', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy. piergiuseppe.agostoni@ccfm.it.'}]",Scientific reports,['10.1038/s41598-020-62644-1']
13,32348374,Surface respiratory electromyography and dyspnea in acute heart failure patients.,"INTRODUCTION AND OBJECTIVES


Dyspnea is the most common symptom among hospitalized patients with heart failure (HF) but besides dyspnea questionnaires (which reflect the subjective patient sensation and are not fully validated in HF) there are no measurable physiological variables providing objective assessment of dyspnea in a setting of acute HF patients. Studies performed in respiratory patients suggest that the measurement of electromyographic (EMG) activity of the respiratory muscles with surface electrodes correlates well with dyspnea. Our aim was to test the hypothesis that respiratory muscles EMG activity is a potential marker of dyspnea severity in acute HF patients.
METHODS


Prospective and descriptive pilot study carried out in 25 adult patients admitted for acute HF. Measurements were carried out with a cardio-respiratory portable polygraph including EMG surface electrodes for measuring the activity of main (diaphragm) and accessory (scalene and pectoralis minor) respiratory muscles. Dyspnea sensation was assessed by means of the Likert 5 questionnaire. Data were recorded during 3 min of spontaneous breathing and after breathing at maximum effort for several cycles for normalizing data. An index to quantify the activity of each respiratory muscle was computed. This assessment was carried out within the first 24 h of admission, and at day 2 and 5.
RESULTS


Dyspnea score decreased along the three measured days. Diaphragm and scalene EMG index showed a positive and significant direct relationship with dyspnea score (p<0.001 and p = 0.003 respectively) whereas pectoralis minor muscle did not.
CONCLUSION


In our pilot study, diaphragm and scalene EMG activity was associated with increasing severity of dyspnea. Surface respiratory EMG could be a useful objective tool to improve assessment of dyspnea in acute HF patients.",2020,"Diaphragm and scalene EMG index showed a positive and significant direct relationship with dyspnea score (p<0.001 and p = 0.003 respectively) whereas pectoralis minor muscle did not.
","['acute heart failure patients', '25 adult patients admitted for acute HF', 'hospitalized patients with heart failure (HF', 'acute HF patients']",[],"['Dyspnea score', 'electromyographic (EMG) activity', 'severity of dyspnea', 'activity of main (diaphragm) and accessory (scalene and pectoralis minor) respiratory muscles', 'Dyspnea sensation', 'Diaphragm and scalene EMG index', 'dyspnea score']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],"[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",25.0,0.0495636,"Diaphragm and scalene EMG index showed a positive and significant direct relationship with dyspnea score (p<0.001 and p = 0.003 respectively) whereas pectoralis minor muscle did not.
","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Luiso', 'Affiliation': 'Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jair A', 'Initials': 'JA', 'LastName': 'Villanueva', 'Affiliation': 'Unit of Biophysics and Bioengineering, School of Medicine and Health Sciences, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laia C', 'Initials': 'LC', 'LastName': 'Belarte-Tornero', 'Affiliation': 'Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Fort', 'Affiliation': 'Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Zorba', 'Initials': 'Z', 'LastName': 'Blázquez-Bermejo', 'Affiliation': 'Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ruiz', 'Affiliation': 'Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Farré', 'Affiliation': 'Unit of Biophysics and Bioengineering, School of Medicine and Health Sciences, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rigau', 'Affiliation': 'Unit of Biophysics and Bioengineering, School of Medicine and Health Sciences, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Martí-Almor', 'Affiliation': 'Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Farré', 'Affiliation': 'Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}]",PloS one,['10.1371/journal.pone.0232225']
14,32349835,Improving social function with real-world social-cognitive remediation in schizophrenia: Results from the RemedRugby quasi-experimental trial.,"BACKGROUND.


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


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


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


Exercise-enriched integrated SCR appears promising to improve real-life functioning in schizophrenia. Future research should investigate the potential effects of this intervention on neuroplasticity and physical fitness.",2020,,['schizophrenia'],[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",[],[],,0.0119092,,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Dubreucq', 'Affiliation': 'Centre de Neurosciences Cognitive, UMR 5229, CNRS and Université Lyon 1, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Gabayet', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ycart', 'Affiliation': 'Laboratoire Jean Kuntzmann, CNRS UMR 5224, Université Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Megane', 'Initials': 'M', 'LastName': 'Faraldo', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Melis', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Arnaud', 'Affiliation': 'Centre Hospitalier Sainte Marie de Clermont Ferrand, 33 rue Gabriel Péri, CS 9912, Clermont-Ferrand Cedex 1 63037, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Bacconnier', 'Affiliation': ""Centre Médical La Teppe, 25 Avenue de la Bouterne, CS 9721, Tain-l'Hermitage Cedex 26602, France.""}, {'ForeName': 'Motassem', 'Initials': 'M', 'LastName': 'Bakri', 'Affiliation': 'Centre de Réhabilitation Psychosociale et de Remédiation Cognitive (C2R), CH Drôme Vivarais, Montéléger, France.'}, {'ForeName': 'Gentiane', 'Initials': 'G', 'LastName': 'Cambier', 'Affiliation': 'Centre Hospitalier de la Savoie, 89 avenue de Bassens, Bassens73000, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chereau', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Titaua', 'Initials': 'T', 'LastName': 'Challe', 'Affiliation': 'Centre Départemental de Réhabilitation Psychosociale des Glières, 219 Chemin des Bois des Fornets, La Roche sur Foron 74800, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Morel', 'Affiliation': 'Centre de Réhabilitation Psychosociale et de Remédiation Cognitive (C2R), CH Drôme Vivarais, Montéléger, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Pires', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Roussel', 'Affiliation': 'Centre Départemental de Réhabilitation Psychosociale des Glières, 219 Chemin des Bois des Fornets, La Roche sur Foron 74800, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Legrand', 'Affiliation': 'Centre Hospitalier Sainte Marie de Clermont Ferrand, 33 rue Gabriel Péri, CS 9912, Clermont-Ferrand Cedex 1 63037, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Pages', 'Affiliation': 'Centre Hospitalier de la Savoie, 89 avenue de Bassens, Bassens73000, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pommier', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Rey', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Yohan', 'Initials': 'Y', 'LastName': 'Souchet', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Pierre-Michel', 'Initials': 'PM', 'LastName': 'Llorca', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Massoubre', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1192/j.eurpsy.2020.42']
15,32289841,Effects of Body Weight vs. Lean Body Mass on Wingate Anaerobic Test Performance in Endurance Athletes.,"The aim of this study was to determine the influence of body weight or lean body mass-based load on Wingate Anaerobic Test performance in male and female endurance trained individuals. Thirty-one participants (22 male cyclists and triathletes and 9 female triathletes) completed two randomized Wingate Anaerobic Test (body weight and lean body mass loads) in stationary start. There were no significant differences in power outputs variables between loads in any group. However, when comparing specific groups within the sample (e. g. cyclists vs cyclists) medium to large effect sizes were observed for Relative Mean Power Output (ES=0.53), Relative Lowest Power (ES=0.99) and Relative Power Muscle Mass (ES=0.54). Regarding gender differences, male cyclists and triathletes displayed higher relative and absolute power outputs (p<0.001) compared to female triathletes regardless of the protocol used. FI was lower in female triathletes compared to male triathletes and cyclists in body weight (p<0.001) and lean body mass (p<0.01) protocols. Body composition and anthropometric characteristics were similar in male cyclists and triathletes, but there were differences between genders. These results suggest that using either body weight-based or lean body mass-based load can be used interchangeably. However, there may be some practically relevant differences when evaluating this on an individual level.",2020,"Body composition and anthropometric characteristics were similar in male cyclists and triathletes, but there were differences between genders.","['Thirty-one participants (22 male cyclists and triathletes and 9 female triathletes', 'male and female endurance trained individuals', 'Endurance Athletes']","['body weight or lean body mass-based load', 'Body Weight vs. Lean Body Mass']",['Body composition and anthropometric characteristics'],"[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}]",31.0,0.070604,"Body composition and anthropometric characteristics were similar in male cyclists and triathletes, but there were differences between genders.","[{'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Galán-Rioja', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'González-Mohíno', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}, {'ForeName': 'Dajo', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'Human Movement Science, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Mellado', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'González-Ravé', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}]",International journal of sports medicine,['10.1055/a-1114-6206']
16,32290681,HIV-related stigma and quality of life in people living with HIV and depressive symptoms: indirect effects of positive coping and perceived stress.,"Despite a strong evidence on the negative association between HIV-related stigma and quality of life (QoL), few studies have examined the indirect effects of this relationship. This study aimed to examine the association between HIV-related stigma and QoL and the indirect effects of positive coping and perceived stress in people living with HIV and depressive symptoms (PLWHD). This study used baseline date from a randomized controlled trial. Structural equation model was used to examine the association between HIV-related stigma and QoL as well as the indirect effects of positive coping and perceived stress. Perceived and internalized stigma had negative direct ( β  = -0.14,  p  < 0.05) effect on QoL. Moreover, perceived and internalized stigma had indirect effects on QoL through decreased positive coping and increased perceived stress ( β  = -0.23,  p  < 0.001). Multilevel interventions to reduce perceived and internalized stigma and perceived stress as well as programs to enhance positive coping may improve QoL of PLWHD. Integrated interventions that both enhance positive coping and reduce perceived stress and stigma are potentially more effective in improving QoL than programs that focus on only one aspect of stigma reduction among PLWHD.",2020,"Perceived and internalized stigma had negative direct ( β  = -0.14,  p  < 0.05) effect on QoL. Moreover, perceived and internalized stigma had indirect effects on QoL through decreased positive coping and increased perceived stress ( β  = -0.23,  p  < 0.001).","['people living with HIV and depressive symptoms', 'people living with HIV and depressive symptoms (PLWHD']",[],['HIV-related stigma and quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0572221,"Perceived and internalized stigma had negative direct ( β  = -0.14,  p  < 0.05) effect on QoL. Moreover, perceived and internalized stigma had indirect effects on QoL through decreased positive coping and increased perceived stress ( β  = -0.23,  p  < 0.001).","[{'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center for Healthcare Quality, Arnold School of Public Health, University of South Carolina, Colombia, USA.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Disease, Guangzhou Eighth People's Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Disease, Guangzhou Eighth People's Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Disease, Guangzhou Eighth People's Hospital, Guangzhou, People's Republic of China.""}]",AIDS care,['10.1080/09540121.2020.1752890']
17,32353714,Music during image-guided breast biopsy reduces patient anxiety levels.,"PURPOSE


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


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


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


Listening to self-selected music reduces anxiety in patients undergoing breast biopsy.",2020,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","['patients undergoing breast biopsy', '157 women between 18 and 75 (mean, 49.7\xa0years) years of age, undergoing stereotactic or ultrasound-guided core biopsy']","['Music intervention', 'music or usual care', 'Listening to self-selected music', 'music group listened to music of their choice during the biopsy', 'Music during image-guided breast biopsy', 'listening to self-selected music during image-guided breast biopsy']","['anxiety', 'pre-biopsy and post-biopsy anxiety levels', 'state anxiety levels', 'Post-biopsy anxiety levels', 'Baseline trait anxiety scores', 'State Trait Anxiety Inventory (STAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",157.0,0.0640536,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","[{'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Bennett', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America. Electronic address: Debbie.bennett@health.slu.edu.'}, {'ForeName': 'J Shannon', 'Initials': 'JS', 'LastName': 'Swan', 'Affiliation': 'MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Gazelle', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America; MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Saksena', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.018']
18,32297974,Interventions for fatigue in inflammatory bowel disease.,"BACKGROUND


Inflammatory bowel disease (IBD) is an umbrella term used to describe a group of chronic, progressive inflammatory disorders of the digestive tract. Crohn's disease and ulcerative colitis are the two main types. Fatigue is a common, debilitating and burdensome symptom experienced by individuals with IBD. The subjective, complex nature of fatigue can often hamper its management. The efficacy and safety of pharmacological or non-pharmacological treatments for fatigue in IBD is not yet established through systematic review of studies.
OBJECTIVES


To assess the efficacy and safety of pharmacological and non-pharmacological interventions for managing fatigue in IBD compared to no treatment, placebo or active comparator.
SEARCH METHODS


A systematic search of the databases Embase, MEDLINE, Cochrane Library, CINAHL, PsycINFO was undertaken from inception to July 2018. A top-up search was run in October 2019. We also searched the Cochrane IBD Group Specialized Register, the Cochrane Central Register of Controlled Trials, ongoing trials and research registers, conference abstracts and reference lists for potentially eligible studies.
SELECTION CRITERIA


Randomised controlled trials of pharmacological and non-pharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or disease-specific fatigue measure, a subscale of a larger quality of life scale or as a single-item measure, were included.
DATA COLLECTION AND ANALYSIS


Two authors independently screened search results and four authors extracted and assessed bias independently using the Cochrane 'Risk of bias' tool. The primary outcome was fatigue and the secondary outcomes included quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs. Standard methodological procedures were used.
MAIN RESULTS


We included 14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions. Thirty ongoing studies were identified, and five studies are awaiting classification. Data on fatigue were available from nine trials (1344 participants). In only four trials was managing fatigue the primary intention of the intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy). Electroacupuncture Fatigue was measured with Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (scores range from 0 to 52). The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence). Results at week 16 could not be calculated. FACIT-F scores were also higher with electroacupuncture compared to sham electroacupuncture at week eight (MD 5.10, 95% CI 3.49 to 6.71; 1 RCT; 30 participants; low-certainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; low-certainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group. Cognitive behavioural therapy (CBT) and solution-focused therapy Compared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel Disease-Fatigue (IBD-F) section I: MD -2.16, 95% CI -6.13 to 1.81; IBD-F section II: MD -21.62, 95% CI -45.02 to 1.78; 1 RCT, 18 participants, very low-certainty evidence). The efficacy of solution-focused therapy on fatigue is also very uncertain, because standard summary data were not reported (1 RCT, 98 participants). Physical activity advice One 2 x 2 factorial trial (45 participants) found physical activity advice may reduce fatigue but the evidence is very uncertain. At week 12, compared to a control group receiving no physical activity advice plus omega 3 capsules, FACIT-F scores were higher (better) in the physical activity advice plus omega 3 group (FACIT-F MD 6.40, 95% CI -1.80 to 14.60, very low-certainty evidence) and the physical activity advice plus placebo group (FACIT-F MD 9.00, 95% CI 1.64 to 16.36, very low-certainty evidence). Adverse events were predominantly gastrointestinal and similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group. Pharmacological interventions Compared with placebo, adalimumab 40 mg, administered every other week ('eow') (only for those known to respond to adalimumab induction therapy), may reduce fatigue in patients with moderately-to-severely active Crohn's disease, but the evidence is very uncertain (FACIT-F MD 4.30, 95% CI 1.75 to 6.85; very low-certainty evidence). The adalimumab 40 mg eow group was less likely to experience serious adverse events (OR 0.56, 95% CI 0.33 to 0.96; 521 participants; moderate-certainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderate-certainty evidence). Ferric maltol may result in a slight increase in fatigue, with better SF-36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD -9.31, 95% CI -17.15 to -1.47; 118 participants; low-certainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; low-certainty evidence) AUTHORS' CONCLUSIONS: The effects of interventions for the management of fatigue in IBD are uncertain. No firm conclusions regarding the efficacy and safety of interventions can be drawn. Further high-quality studies, with a larger number of participants, are required to assess the potential benefits and harms of therapies. Future studies should assess interventions specifically designed for fatigue management, targeted at selected IBD populations, and measure fatigue as the primary outcome.",2020,"The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence).","['14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions', 'children or adults with IBD']","['placebo, adalimumab', 'Cognitive behavioural therapy (CBT) and solution-focused therapy', 'intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy', 'placebo', 'pharmacological and non-pharmacological interventions', 'electroacupuncture', 'physical activity advice', 'CBT', 'adalimumab', 'sham electroacupuncture', 'physical activity advice plus placebo']","['adverse events', 'Adverse events', 'quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs', ""Crohn's disease and ulcerative colitis"", 'FACIT-F scores', 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F', 'fatigue', 'efficacy and safety', 'generic or disease-specific fatigue measure, a subscale of a larger quality of life scale', 'experience serious adverse events', 'moderate-certainty evidence) and withdrawal due to adverse events', 'FACIT-F score', 'Electroacupuncture Fatigue', 'SF-36 vitality scores']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]",45.0,0.243237,"The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence).","[{'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'Institute of Technology Tralee, Department of Nursing and Healthcare Sciences, Tralee, County Kerry, Ireland.'}, {'ForeName': 'Micol', 'Initials': 'M', 'LastName': 'Artom', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA.""}, {'ForeName': 'Wladyslawa', 'Initials': 'W', 'LastName': 'Czuber-Dochan', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA.""}, {'ForeName': 'Lars P', 'Initials': 'LP', 'LastName': 'Jelsness-Jørgensen', 'Affiliation': 'Østfold University College, Health Sciences, Høgskolen i Østfold, Postboks 700, Halden, Norway, NO-1757.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, 57 Waterloo Road, London, UK, SE1 8WA.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Savage', 'Affiliation': 'University College Cork, School of Nursing and Midwifery, Brookfield Health Sciences Complex, Cork, Ireland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012005.pub2']
19,32356923,Evaluating the Perceived Efficacy of Randomized Security Measures at Airports.,"Both the increase in traveler numbers and the heightened threat posed by terrorism in recent years represent significant challenges to airport security measures. To ensure that a high level of security is maintained, randomized security checks have been proposed as a promising alternative to traditional security approaches. The use of randomized checks means that only a specific number of people are selected for security screening. However, the likely effects of such a change in security procedures on travelers' security perceptions and on the deterrence of criminal activities remain unclear. Thus, the present study examines how varying the percentage of people screened during security checks influences people's security perceptions. In two online experiments, the participants were asked to imagine that they sought to smuggle an explosive dummy past an airport security check. The only information provided was the number of people screened during security checks, which was manipulated between-subjects in the first experiment and within-subjects in the second experiment. The participants then had to rate their security perception (i.e., the perceived likelihood of successfully smuggling the explosive dummy). The findings show that people perceive traditional security checks to be safer than randomized checks, irrespective of whether 90% or 30% of people are screened. Hence, if randomized security checks would indeed be implemented, it would automatically lead to a decreased perception of security. Furthermore, this decreased security perception might lead to an actual reduction in security, as the deterrence of criminal activities could also be reduced.",2020,"The findings show that people perceive traditional security checks to be safer than randomized checks, irrespective of whether 90% or 30% of people are screened.",[],[],['rate their security perception'],[],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0315659,"The findings show that people perceive traditional security checks to be safer than randomized checks, irrespective of whether 90% or 30% of people are screened.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Stotz', 'Affiliation': 'ETH Zurich, Consumer Behavior, Zurich, 8092, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bearth', 'Affiliation': 'ETH Zurich, Consumer Behavior, Zurich, 8092, Switzerland.'}, {'ForeName': 'Signe Maria', 'Initials': 'SM', 'LastName': 'Ghelfi', 'Affiliation': 'Zurich State Police, Airport Division - Research and Development, P.O. Box, Zurich-Airport, 8058, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siegrist', 'Affiliation': 'ETH Zurich, Consumer Behavior, Zurich, 8092, Switzerland.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13474']
20,32358697,Moderators of School Intervention Outcomes for Children with Autism Spectrum Disorder.,"A prior cluster randomized controlled trial (RCT) compared outcomes for a comprehensive school intervention (schoolMAX) to typical educational programming (services-as-usual [SAU]) for 103 children with autism spectrum disorder (ASD) without intellectual disability. The schoolMAX intervention was superior to SAU in improving social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms). In the current study, a range of demographic, clinical, and school variables were tested as potential moderators of treatment outcomes from the prior RCT. Moderation effects were not evident in demographics, child IQ, language, or ASD diagnostic symptoms, or school SES. Baseline externalizing symptoms moderated the outcome of social-cognitive understanding and adaptive skills moderated the outcome of ASD-related symptoms (no other comorbid symptoms or adaptive skills ratings moderated outcomes on the three measures). Overall, findings suggest that the main effects of treatment were, with two exceptions, unaffected by third variables.",2020,"The schoolMAX intervention was superior to SAU in improving social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms).","['Children with Autism Spectrum Disorder', '103 children with autism spectrum disorder (ASD) without intellectual disability']",['comprehensive school intervention (schoolMAX) to typical educational programming (services-as-usual [SAU'],"['demographics, child IQ, language, or ASD diagnostic symptoms, or school SES', 'social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0557796', 'cui_str': 'Comprehensive school'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",103.0,0.0390846,"The schoolMAX intervention was superior to SAU in improving social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms).","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lopata', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA. lopatac@canisius.edu.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Donnelly', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Thomeer', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Rodgers', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lodi-Smith', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Booth', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Volker', 'Affiliation': 'Center for Research in Autism, Intellectual, and Other Neurodevelopmental Disabilities, Michigan State University, East Lansing, MI, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00652-5']
21,32357088,"Are Low-Income, Diverse Mothers Able to Meet Breastfeeding Intentions After 2 Months of Breastfeeding?","Background:  Little is known about intended breastfeeding duration of women who initiate breastfeeding. We describe the association between intended and actual breastfeeding duration among low-income, diverse mothers who report maintaining breastfeeding for the first 2 months postpartum.  Materials and Methods:  We included mothers (64% Hispanic, 17% non-Hispanic black) participating in Greenlight, a cluster randomized childhood obesity prevention trial, who were providing breast milk at the 2-month preventive service visit and reported intended breastfeeding duration at this visit. Breastfeeding status was assessed at subsequent visits, up to 24 months. Poisson regression with a robust variance estimator was used to estimate risk ratios and 95% confidence intervals for meeting breastfeeding intentions. Covariates included race/ethnicity, income, receiving benefits from the Special Supplemental Nutrition Assistance Program for Women, Infants and Children (WIC), education, age, employment, depression, maternal obesity, U.S. born, whether infant was first born, and study site.  Results:  Median intended breastfeeding duration was 11.5 months (interquartile range [IQR]: 6-12) and median actual breastfeeding duration was 8.6 months (IQR: 4-14) ( n  = 349). Approximately half (49%) met intended breastfeeding duration. Breastfeeding duration differed based on milk type provided at the 2-month visit in that mothers providing mostly or only breast milk had increased likelihood of meeting breastfeeding intentions. Regardless of milk type provided at 2 months, the longer a mother intended to breastfeed, the less likely she was to meet her breastfeeding intentions.  Conclusions:  In this diverse sample of women less than half met breastfeeding intentions despite maintaining breastfeeding for 2 months. Understanding factors that prevent mothers from attaining intended breastfeeding duration is critical to improving breastfeeding outcomes, especially in low income and ethnic minority populations.",2020,"Regardless of milk type provided at 2 months, the longer a mother intended to breastfeed, the less likely she was to meet her breastfeeding intentions.  ","['mothers (64% Hispanic, 17% non-Hispanic black) participating in Greenlight, a cluster randomized childhood obesity prevention trial, who were providing breast milk at the 2-month preventive service visit and reported intended breastfeeding duration at this visit', 'low-income, diverse mothers who report maintaining breastfeeding for the first 2 months postpartum', 'for Women, Infants and Children (WIC), education, age, employment, depression, maternal obesity, U.S. born, whether infant was first born, and study site']",['Special Supplemental Nutrition Assistance Program'],"['Median intended breastfeeding duration', 'Breastfeeding status', 'median actual breastfeeding duration', 'Breastfeeding duration', 'likelihood of meeting breastfeeding intentions']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199175', 'cui_str': 'Preventive service'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0746977', 'cui_str': 'Maternal Obesity'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0397174,"Regardless of milk type provided at 2 months, the longer a mother intended to breastfeed, the less likely she was to meet her breastfeeding intentions.  ","[{'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Kay', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Rushina', 'Initials': 'R', 'LastName': 'Cholera', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Kori B', 'Initials': 'KB', 'LastName': 'Flower', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'H Shonna', 'Initials': 'HS', 'LastName': 'Yin', 'Affiliation': 'New York University School of Medicine, New York, New York, USA.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Sanders', 'Affiliation': 'Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Delamater', 'Affiliation': 'University of Miami School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Eliana M', 'Initials': 'EM', 'LastName': 'Perrin', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0025']
22,32367867,"Prevention of postanesthetic shivering under subarachnoid block for cesarean section: A randomized, controlled study comparing tramadol versus ondansetron.","Background


Shivering is a frequent undesirable event in patients undergoing cesarean delivery under spinal anesthesia. Postanesthetic shivering has a multitude of deleterious effects and different methods have been used to prevent it. We therefore compare the efficacy of ondansetron to that of tramadol in preventing postanesthetic shivering in women undergoing cesarean section under subarachnoid block.
Aim


Comparison of the efficacy of ondansetron to that of tramadol in preventing postanesthetic shivering in women undergoing cesarean section under subarachnoid block.
Subject and Methods


This is a prospective, double-blind, placebo-controlled, randomized study. The patients (n = 109) were randomly allocated to three groups according to the study drugs, namely tramadol 50 mg group (Group T), ondansetron 4 mg group (Group O), and saline 4 ml group (Group S) using envelope randomization. Statistical analyses were done using Statistical Package for Social Sciences 20.0.
Results


A total of 100 patients completed the study (33 in Group S, 33 in Group T, and 34 in Group O). The three groups were comparable with respect to demographic characteristics. Shivering was observed in 16 (48.5%) of the patients in Group S; 13 (39.4%) patients in Group T, and in only 2 (5.9%) patients in Group O. The differences in incidence of shivering were statistically significant between Groups O and S (P = 0.000) and Groups O and T (P = 0.001) but not between Groups T and S (P = 0.460). The differences across the groups were not statistically significant in terms of incidence of intraoperative hypotension, bradycardia, and the cumulative amount of ephedrine consumed.
Conclusion


This study demonstrated that ondansetron is superior to tramadol in preventing shivering under spinal anesthesia in women undergoing cesarean section.",2020,The differences in incidence of shivering were statistically significant between Groups O and S (P = 0.000) and Groups O and T (P = 0.001) but not between Groups T and S (P = 0.460).,"['patients (n = 109', 'cesarean section', 'patients undergoing cesarean delivery under spinal anesthesia', 'women undergoing cesarean section', '100 patients completed the study (33 in Group S, 33 in Group T, and 34 in Group O', 'women undergoing cesarean section under subarachnoid block']","['tramadol', 'postanesthetic shivering under subarachnoid block', 'tramadol 50 mg group (Group T), ondansetron 4 mg group (Group O), and saline 4 ml group', 'ondansetron', 'placebo']","['Shivering', 'incidence of shivering', 'postanesthetic shivering', 'incidence of intraoperative hypotension, bradycardia, and the cumulative amount of ephedrine consumed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0427626', 'cui_str': 'Group O'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C1123367', 'cui_str': 'Ondansetron 4 MG'}, {'cui': 'C0427626', 'cui_str': 'Group O'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]",109.0,0.078898,The differences in incidence of shivering were statistically significant between Groups O and S (P = 0.000) and Groups O and T (P = 0.001) but not between Groups T and S (P = 0.460).,"[{'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Nnacheta', 'Affiliation': 'Department of Anaesthesia, University of Nigeria Teaching Hospital, Ituku Ozalla, Enugu, Nigeria.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Onyekwulu', 'Affiliation': 'Department of Anaesthesia, University of Nigeria Teaching Hospital, Ituku Ozalla, Enugu, Nigeria.'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Amucheazi', 'Affiliation': 'Department of Anaesthesia, University of Nigeria Teaching Hospital, Ituku Ozalla, Enugu, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_641_18']
23,32367870,Misoprostol versus manual vacuum aspiration for treatment of first-trimester incomplete miscarriage in a low-resource setting: A randomized controlled trial.,"Background


Manual vacuum aspiration is a safe and effective technology for the treatment of incomplete miscarriage but it is not widely available and affordable in rural areas particularly in low-resource countries. Misoprostol is an alternative to manual vacuum aspiration for the treatment of incomplete miscarriage.
Aim


To compare the effectiveness, client acceptability and satisfaction, and cost-effectiveness of misoprostol with manual vacuum aspiration for the treatment of the first-trimester incomplete miscarriage.
Subjects and Methods


This study was conducted between February 1, 2018 and August 31, 2018 at Alex Ekwueme Federal University Teaching Hospital Abakaliki, Nigeria. 100 participants were randomized to treatment with either manual vacuum aspiration or 600 μg oral misoprostol. The main outcome measures assessed at 1-week follow-up were complete uterine evacuation, client acceptability and satisfaction, and cost-effectiveness. Data were analyzed using SPSS version 25. Sociodemographic characteristics, treatment outcomes and other variables were summarized by descriptive statistics. Chi-square test was used for comparison between groups as regard categorical data while Student's't' test was used for comparison between groups for continuous data. P value of <0.05 was regarded as statistically significant.
Results


There was a higher failure rate in the misoprostol arm when compared with MVA. Although this difference in complete uterine evacuation rate did not reach statistical significance (81.3% versus 95.7%, RR = 4.3, 95% CI 0.98-18.9, P value = 0.05), more participants in the misoprostol arm would choose the method again when compared with women in the MVA group (47 versus 30, X [2]  = 16.95, P < 0.001). The mean client satisfaction score was significantly higher among women in the misoprostol arm compared to MVA group (13.2 (2.1) versus 7.3 (4.6), P < 0.001). The mean cost of primary treatment was higher in the MVA group compared with misoprostol arm ($67.8 (8.9) versus 14.4 (4.0), P < 0.001). There was no significant difference in the mean cost of repeat uterine evacuation in both study arms (MVA, $64.9 (6.3) versus misoprostol, $65.76 (6.6), P = 0.86).
Conclusion


Although medical treatment was associated with a higher failure rate, there was no statistically significant difference in the effectiveness of both treatment methods. However, medical treatment was associated with higher client acceptance and satisfaction and was more cost-effective than surgical treatment.",2020,"Although medical treatment was associated with a higher failure rate, there was no statistically significant difference in the effectiveness of both treatment methods.","['February 1, 2018 and August 31, 2018 at Alex Ekwueme Federal University Teaching Hospital Abakaliki, Nigeria', 'first-trimester incomplete miscarriage in a low-resource setting', 'Subjects and Methods', '100 participants']","['misoprostol with manual vacuum aspiration', 'manual vacuum aspiration', 'MVA', 'Misoprostol', 'misoprostol', '\n\n\nManual vacuum aspiration', 'manual vacuum aspiration or 600 μg oral misoprostol']","['mean cost of repeat uterine evacuation', 'mean client satisfaction score', 'mean cost of primary treatment', 'effectiveness, client acceptability and satisfaction, and cost-effectiveness', 'failure rate', 'client acceptance and satisfaction', 'cost-effective', 'complete uterine evacuation rate', 'complete uterine evacuation, client acceptability and satisfaction, and cost-effectiveness']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0000810', 'cui_str': 'Incomplete miscarriage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0042223', 'cui_str': 'Suction Curettage'}, {'cui': 'C0052712', 'cui_str': 'AVM protocol'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",100.0,0.169657,"Although medical treatment was associated with a higher failure rate, there was no statistically significant difference in the effectiveness of both treatment methods.","[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Nwafor', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, South-East Nigeria.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Agwu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, South-East Nigeria.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Egbuji', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, South-East Nigeria.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Ekwedigwe', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, South-East Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_379_19']
24,32359153,Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern Does Not Adversely Affect the Cardiometabolic Risk Factor Profile in Men and Women at Risk for Type 2 Diabetes.,"BACKGROUND


Observational evidence suggests that red meat intake is associated with type 2 diabetes (T2D) and cardiovascular disease incidence, but few randomized controlled trials have assessed effects of lean, unprocessed red meat intake on insulin sensitivity and other cardiometabolic risk factors.
OBJECTIVE


This study compared the USDA Healthy US-Style Eating Pattern, low in saturated fat and red meat (<40 g/d red meat; USDA-CON), with a modified version with an additional 150 g/d lean beef as an isocaloric replacement for carbohydrate (USDA-LB) on insulin sensitivity and cardiometabolic risk markers.
METHODS


Participants (7 men, 26 women; 44.4 y old) with overweight/obesity [BMI (kg/m2) = 31.3] and prediabetes and/or metabolic syndrome completed this randomized, crossover, controlled-feeding trial consisting of two 28-d treatments (USDA-CON and USDA-LB) separated by a ≥14-day washout. Insulin sensitivity (primary outcome variable), lipoprotein lipids, apolipoproteins (apoA-I and apoB), and high-sensitivity C-reactive protein (hs-CRP) (secondary outcome variables), in plasma or serum, and blood pressures were assessed at baseline and the end of each diet period.
RESULTS


USDA-LB and USDA-CON did not differ significantly in effects on whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures. USDA-LB produced a shift toward less cholesterol carried by smaller LDL subfractions compared with USDA-CON [least-squares geometric mean ratios for LDL1+2 cholesterol of 1.20 (P = 0.016) and LDL3+4 cholesterol of 0.89 (P = 0.044)] and increased peak LDL time versus USDA-CON (1.01; P = 0.008).
CONCLUSIONS


Substituting lean, unprocessed beef for carbohydrate in a Healthy US-Style Eating Pattern resulted in a shift toward larger, more buoyant LDL subfractions, but otherwise had no significant effects on the cardiometabolic risk factor profile in men and women with prediabetes and/or metabolic syndrome.This trial was registered at clinicaltrials.gov as NCT03202680.",2020,"RESULTS


USDA-LB and USDA-CON did not differ significantly in effects on whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures.","['men and women with prediabetes and/or metabolic syndrome', 'Men and Women at Risk for Type 2 Diabetes', 'Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern', 'Participants (7 men, 26 women; 44.4 y old) with overweight/obesity [BMI (kg/m2)\xa0=\xa031.3] and prediabetes']",[],"['whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures', 'peak LDL time', 'cardiometabolic risk factor profile', 'Insulin sensitivity (primary outcome variable), lipoprotein lipids, apolipoproteins (apoA-I and apoB), and high-sensitivity C-reactive protein (hs-CRP) (secondary outcome variables), in plasma or serum, and blood pressures', 'Cardiometabolic Risk Factor Profile']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0302820', 'cui_str': 'Metabolism, Carbohydrate'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.238139,"RESULTS


USDA-LB and USDA-CON did not differ significantly in effects on whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Buggia', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa116']
25,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
26,32345358,Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial.,"BACKGROUND


During hospitalization, many older patients are at nutritional risk or malnourished, and their nutritional condition is often further impaired during hospitalization. After discharge, a ""nutrition gap"" often occurs in which the patient does not receive enough nutrition to ensure an optimal recovery.
METHODS


The study is a randomized controlled study ongoing over 112 days. At discharge, the intervention group receives guidance from a clinical dietitian, and an individualized nutrition plan is made. The dietitian will perform telephone follow-up after 4 and 30 days. It will also be possible for the participant, the participant's relatives, or the participant's municipality to contact the dietitian if nutritional questions arise. At the time of discharge, the intervention group will receive a package containing foods and drinks that will cover their nutritional needs on the first day after discharge. They will also receive a goodie bag containing samples of protein-rich, milk-based drinks. Data are collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, and experience of discharge and cooperation with the municipality. Information about nutrition status will be sent to the municipality so that the municipality can take over nutritional treatment. The control group receives a standard treatment.
DISCUSSION


This study is the first to combine previously successful single nutritional interventions into a multimodal intervention whose aim is to obtain an effect on patient-related outcomes. We hope that the results will prove beneficial and help to ensure the cross-sector quality of nutritional support to older patients.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03488329. April 5, 2018.",2020,"Data are collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, and experience of discharge and cooperation with the municipality.",['discharged older patients'],"['nutritional interventions', 'standard treatment']","['quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, and experience of discharge and cooperation with the municipality']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.046197,"Data are collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, and experience of discharge and cooperation with the municipality.","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Munk', 'Affiliation': 'Dietetic and Nutritional Research Unit, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Jonas Anias', 'Initials': 'JA', 'LastName': 'Svendsen', 'Affiliation': 'Dietetic and Nutritional Research Unit, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Anne Wilkens', 'Initials': 'AW', 'LastName': 'Knudsen', 'Affiliation': 'Dietetic and Nutritional Research Unit, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Tanja Bak', 'Initials': 'TB', 'LastName': 'Østergaard', 'Affiliation': 'Dietetic and Nutritional Research Unit, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Beck', 'Affiliation': 'Dietetic and Nutritional Research Unit, Herlev-Gentofte University Hospital, Herlev, Denmark. ambe@kp.dk.'}]",Trials,['10.1186/s13063-020-04301-6']
27,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
28,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
29,32352165,Aspirin and other non-steroidal anti-inflammatory drugs for the prevention of dementia.,"BACKGROUND


Dementia is a worldwide concern. Its global prevalence is increasing. At present, there is no medication licensed to prevent or delay the onset of dementia. Inflammation has been suggested as a key factor in dementia pathogenesis. Therefore, medications with anti-inflammatory properties could be beneficial for dementia prevention.
OBJECTIVES


To evaluate the effectiveness and adverse effects of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) for the primary or secondary prevention of dementia.
SEARCH METHODS


We searched ALOIS, the specialised register of the Cochrane Dementia and Cognitive Improvement Group up to 9 January 2020. ALOIS contains records of clinical trials identified from monthly searches of several major healthcare databases, trial registries and grey literature sources. We ran additional searches across MEDLINE (OvidSP), Embase (OvidSP) and six other databases to ensure that the searches were as comprehensive and up-to-date as possible. We also reviewed citations of reference lists of included studies.
SELECTION CRITERIA


We searched for randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing aspirin or other NSAIDs with placebo for the primary or secondary prevention of dementia. We included trials with cognitively healthy participants (primary prevention) or participants with mild cognitive impairment (MCI) or cognitive complaints (secondary prevention).
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the strength of evidence for each outcome using the GRADE approach.
MAIN RESULTS


We included four RCTs with 23,187 participants. Because of the diversity of these trials, we did not combine data to give summary estimates, but presented a narrative description of the evidence. We identified one trial (19,114 participants) comparing low-dose aspirin (100 mg once daily) to placebo. Participants were aged 70 years or older with no history of dementia, cardiovascular disease or physical disability. Interim analysis indicated no significant treatment effect and the trial was terminated slightly early after a median of 4.7 years' follow-up. There was no evidence of a difference in incidence of dementia between aspirin and placebo groups (risk ratio (RR) 0.98, 95% CI 0.83 to 1.15; high-certainty evidence). Participants allocated aspirin had higher rates of major bleeding (RR 1.37, 95% CI 1.17 to 1.60, high-certainty evidence) and slightly higher mortality (RR 1.14, 95% CI 1.01 to 1.28; high-certainty evidence). There was no evidence of a difference in activities of daily living between groups (RR 0.84, 95% CI 0.70 to 1.02; high-certainty evidence). We identified three trials comparing non-aspirin NSAIDs to placebo. All three trials were terminated early due to adverse events associated with NSAIDs reported in other trials. One trial (2528 participants) investigated the cyclo-oxygenase-2 (COX-2) inhibitor celecoxib (200 mg twice daily) and the non-selective NSAID naproxen (220 mg twice daily) for preventing dementia in cognitively healthy older adults with a family history of Alzheimer's disease (AD). Median follow-up was 734 days. Combining both NSAID treatment arms, there was no evidence of a difference in the incidence of AD between participants allocated NSAIDs and those allocated placebo (RR 1.91, 95% CI 0.89 to 4.10; moderate-certainty evidence). There was also no evidence of a difference in rates of myocardial infarction (RR 1.21, 95% CI 0.61 to 2.40), stroke (RR 1.82, 95% CI 0.76 to 4.37) or mortality (RR 1.37, 95% CI 0.78 to 2.43) between treatment groups (all moderate-certainty evidence). One trial (88 participants) assessed the effectiveness of celecoxib (200 mg or 400 mg daily) in delaying cognitive decline in participants aged 40 to 81 years with mild age-related memory loss but normal memory performance scores. Mean duration of follow-up was 17.6 months in the celecoxib group and 18.1 months in the placebo group. There was no evidence of a difference between groups in test scores in any of six cognitive domains. Participants allocated celecoxib experienced more gastrointestinal adverse events than those allocated placebo (RR 2.66, 95% CI 1.05 to 6.75; low-certainty evidence). One trial (1457 participants) assessed the effectiveness of the COX-2 inhibitor rofecoxib (25 mg once daily) in delaying or preventing a diagnosis of AD in participants with MCI. Median duration of study participation was 115 weeks in the rofecoxib group and 130 weeks in the placebo group. There was a higher incidence of AD in the rofecoxib than the placebo group (RR 1.32, 95% CI 1.01 to 1.72; moderate-certainty evidence). There was no evidence of a difference between groups in cardiovascular adverse events (RR 1.07, 95% CI 0.68 to 1.66; moderate-certainty evidence) or mortality (RR 1.62, 95% CI 0.85 to 3.05; moderate-certainty evidence). Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence). Reported annual mean difference scores showed no evidence of a difference between groups in activities of daily living (year 1: no data available; year 2: 0.0, 95% CI -0.1 to 0.2; year 3: 0.1, 95% CI -0.1 to 0.3; year 4: 0.1, 95% CI -0.1 to 0.4; moderate-certainty evidence).
AUTHORS' CONCLUSIONS


There is no evidence to support the use of low-dose aspirin or other NSAIDs of any class (celecoxib, rofecoxib or naproxen) for the prevention of dementia, but there was evidence of harm. Although there were limitations in the available evidence, it seems unlikely that there is any need for further trials of low-dose aspirin for dementia prevention. If future studies of NSAIDs for dementia prevention are planned, they will need to be cognisant of the safety concerns arising from the existing studies.",2020,"Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence).","['participants with MCI', '23,187 participants', 'participants aged 40 to 81 years with mild age-related memory loss but normal memory performance scores', 'Participants were aged 70 years or older with no history of dementia, cardiovascular disease or physical disability', 'cognitively healthy participants (primary prevention) or participants with mild cognitive impairment (MCI) or cognitive complaints (secondary prevention', ""cognitively healthy older adults with a family history of Alzheimer's disease (AD""]","['aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs', 'cyclo-oxygenase-2 (COX-2) inhibitor celecoxib (200 mg twice daily) and the non-selective NSAID naproxen', 'Aspirin and other non-steroidal anti-inflammatory drugs', 'celecoxib ', 'aspirin', 'celecoxib', 'aspirin and placebo', 'class (celecoxib, rofecoxib or naproxen', 'aspirin or other NSAIDs with placebo', 'rofecoxib', 'COX-2 inhibitor rofecoxib', 'placebo']","['Mean duration', 'risk ratio (RR', 'delaying cognitive decline', 'rates of myocardial infarction', 'gastrointestinal adverse events', 'stroke', 'cardiovascular adverse events', 'mortality', 'incidence of dementia', 'incidence of AD', 'rates of major bleeding', 'Median duration of study participation', 'upper gastrointestinal adverse events', 'activities of daily living']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1271045', 'cui_str': ""FH: Alzheimer's disease""}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0762662', 'cui_str': 'rofecoxib'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",19114.0,0.686924,"Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence).","[{'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Jordan', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'McGuinness', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Passmore', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kelly', 'Affiliation': 'Pharmacology and Therapeutics, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur Smith', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011459.pub2']
30,32349742,The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial.,"BACKGROUND


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


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


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


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


Clinical trials NCT03860350, retrospectively registered (1/32019).",2020,"There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and","['university hospital in Europe', '104 patients were randomized and 46 in the active group and 47 in the', 'Patients with a Framingham risk score\u2009≥\u200910 after CT scan (n\u2009=\u2009104']","['placebo or AGE', 'aged garlic extract', 'aged garlic extract (AGE', 'placebo']","['blood pressure', 'blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers', 'CAC progression', 'blood glucose', 'accuracy score for CAC progression', 'CAC progression, lowers IL-6, glucose levels and blood pressure', 'IL-6', 'systolic blood pressure', 'changes in CAC score']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",104.0,0.616204,"There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and","[{'ForeName': 'Martiné', 'Initials': 'M', 'LastName': 'Wlosinska', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hlebowicz', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hauggaard', 'Affiliation': 'Department of Radiology, Cardiac Imaging, Skåne Hospital Northwest, Helsingborg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kjellin', 'Affiliation': 'Department of Radiology, Cardiac Imaging, Skåne Hospital Northwest, Helsingborg, Sweden.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Fakhro', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lindstedt', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Sciences, Lund University, Skåne University Hospital, SE-221 85, Lund, Sweden. sandra.lindstedt.ingemansson@gmail.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02932-5']
31,32349746,"Comparison of explicit values clarification method (VCM), implicit VCM and no VCM decision aids for men considering prostate cancer screening: protocol of a randomized trial.","BACKGROUND


Screening with prostate-specific antigen (PSA) test for prostate cancer is considered a preference sensitive decision; meaning it does not only depend on what is best from a medical point of view, but also from a patient value standpoint. Decision aids are evidence-based tools which are shown to help people feel clearer about their values; therefore it has been advocated that decision aids should contain a specific values clarification method (VCM). VCMs may be either implicit or explicit, but the evidence concerning the best method is scarce. We aim to compare the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM.
METHODS


Male factory employees from an industrial facility in the Northern region of Portugal aged 50 to 69 years old will be randomly assigned to one of three decision aid groups used to support prostate cancer screening decisions: (i) decision aid with information only (control), (ii) decision aid with information plus an implicit VCM, (iii) decision aid with information plus an explicit VCM. Men will be allowed release time from work to attend a session at their workplace. After a brief oral presentation, those willing to participate in the study will fill the baseline questionnaire, plus a 5 point-Likert scale question about intentions to undergo screening, and will then receive the intervention materials to complete. We estimated a total sample size of 276 participants; with 92 in each group. The primary outcome will be the perceived clarity of personal values assessed by the Portuguese validated translation of the three subscales of the Decisional Conflict Scale. Secondary outcomes will be intention to be screened (before and after the intervention), the total score from the Decisional Conflict Scale and the self-report of having or not undergone screening at 6 months.
DISCUSSION


This study will add to the body of evidence on the role of decision aids to support health preference-sensitive choices and provide further insight on the impact of different methods for eliciting people's values embedded within a decision aid.
TRIAL REGISTRATION


NCT03988673 - clinicalTrials.gov (2019/06/17).",2020,"We aim to compare the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM.
","['total sample size of 276 participants; with 92 in each group', 'men considering PSA screening using decision aids with no', 'men considering prostate cancer screening', 'Male factory employees from an industrial facility in the Northern region of Portugal aged 50 to 69\u2009years old']","['VCM versus an implicit VCM', 'explicit values clarification method (VCM), implicit VCM and no VCM decision aids', 'decision aid groups used to support prostate cancer screening decisions: (i) decision aid with information only (control), (ii) decision aid with information plus an implicit VCM, (iii) decision aid with information plus an explicit VCM']","['total score from the Decisional Conflict Scale and the self-report of having or not undergone screening at 6\u2009months', 'perceived clarity of personal values assessed by the Portuguese validated translation of the three subscales of the Decisional Conflict Scale']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0442614', 'cui_str': 'Factory'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0442620', 'cui_str': 'Industrial plant'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1319687', 'cui_str': 'No value'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0040712', 'cui_str': 'Translations'}]",276.0,0.0841233,"We aim to compare the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baptista', 'Affiliation': 'Department of Community Medicine, Information and Health Decision Sciences (MEDCIDS), Faculty of Medicine, University of Porto, Al. Prof. Hernâni Monteiro, 4200 - 319, Porto, Portugal. baptistas@med.up.pt.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Heleno', 'Affiliation': 'Comprehensive Health Research Center (CHRC), Universidade NOVA de Lisboa, Lisboa, Portugal.5 - NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Department of Community Medicine, Information and Health Decision Sciences (MEDCIDS), Faculty of Medicine, University of Porto, Al. Prof. Hernâni Monteiro, 4200 - 319, Porto, Portugal.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Taylor', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, D.C, United States of America.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Martins', 'Affiliation': 'Department of Community Medicine, Information and Health Decision Sciences (MEDCIDS), Faculty of Medicine, University of Porto, Al. Prof. Hernâni Monteiro, 4200 - 319, Porto, Portugal.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-1094-3']
32,32353635,Feasibility of decision rule-based treatment of comorbid youth: A pilot randomized control trial.,"This study examined the feasibility, acceptability, and preliminary efficacy of a decision rule driven treatment for youth with comorbid conduct problems and depression. A randomized, controlled, repeated measures design was used to compare two treatment approaches: Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ). Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions. Both treatments showed similar remission of internalizing and externalizing diagnoses. Participants in DR showed significantly greater improvements at six-month follow-up in child-reported depressive symptom severity compared to SEQ. Both DR and SEQ conditions showed significantly lower behavior problems at end of treatment and six-month follow-up. DR showed significant reductions in emotion dysregulation at 6-month follow-up, while SEQ did not. Findings suggest that a decision rule based intervention holds promise as a feasible and acceptable treatment with high rates of remittance.",2020,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","['Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder', 'youth with comorbid conduct problems and depression', 'comorbid youth']",['Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ'],"['remission of internalizing and externalizing diagnoses', 'behavior problems', 'depressive symptom severity', 'emotion dysregulation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0310239,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA. Electronic address: jennifer_wolff@brown.edu.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA; University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Frazier', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103625']
33,32356084,Is Essentialism Essential? Reducing Homonegative Prejudice by Targeting Diverse Sexual Orientation Beliefs.,"We conducted an experiment to assess whether targeting multiple beliefs about sexual orientation (SO) may be more effective in reducing homonegativity than focusing only on beliefs about its biogenetic origins. Participants (116 women, 85 men) were randomly assigned to one of three treatment conditions or a control condition. Those in the treatment conditions read essays summarizing: (1) research suggesting SO has biogenetic origins, (2) research suggesting SO is socially constructed and refuting beliefs about the discreteness, homogeneity, and informativeness of SO categories; or (3) research suggesting SO is biogenetic and research suggesting SO categories are socially constructed and not necessarily discrete, homogenous, or informative. We predicted participants in the conditions that targeted multiple beliefs related to the social construction of SO, not just its biogenetic origins, would exhibit the strongest reductions in beliefs about the discreteness, homogeneity, and informativeness of SO categories, and in homonegativity. We also predicted these participants would exhibit the greatest increases in support for gay and lesbian civil rights. We observed hypothesized shifts in SO beliefs across all experimental conditions. While there was a small main effect of time on homonegative prejudice, there was no main effect of condition and no changes in support for gay and lesbian civil rights. However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction. Implications for more comprehensive educational and social interventions designed to promote social justice for sexual minorities are discussed.",2020,"However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction.","['Participants (116 women, 85 men']",[],[],"[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],[],116.0,0.0209656,"However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction.","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Fry', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Grzanka', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA. patrick.grzanka@utk.edu.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Miles', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}, {'ForeName': 'Elliott N', 'Initials': 'EN', 'LastName': 'DeVore', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}]",Archives of sexual behavior,['10.1007/s10508-020-01706-x']
34,32365097,"A phase 2, double-blind, multicenter, randomized, placebo-controlled, dose‑ranging study of the efficacy and safety of Astodrimer Gel for the treatment of bacterial vaginosis.","BACKGROUND


Astodrimer Gel contains a novel dendrimer intended to treat and prevent bacterial vaginosis. We assessed the efficacy and safety of Astodrimer Gel for treatment of bacterial vaginosis.
METHODS


132 women with bacterial vaginosis were randomized 1:1:1:1 to Astodrimer 0.5% (N = 34), 1% (N = 33), or 3% (N = 32) Gel or hydroxyethyl cellulose placebo gel (N = 33) at a dose of 5 g vaginally once daily for 7 days at 6 centers in the United States. The primary endpoint was clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5; 2) ≥20% clue cells; or 3) positive whiff test) at study days 21-30. Secondary analyses included clinical cure at study days 9-12, patient-reported symptoms, acceptability and adverse events.
RESULTS


The Astodrimer 1% Gel dose was superior to placebo for the primary and selected secondary efficacy measures in the modified intent-to-treat population. Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]). At day 21-30, clinical cure rates were 46.2% (12/26) for the 1% dose vs. 11.5% for placebo (3/26; P = .006). A greater proportion of patients reported absence of vaginal discharge and vaginal odor at day 9-12 and day 21-30 for Astodrimer Gel groups compared with placebo. Adverse events considered potentially treatment-related occurred in only 25% of Astodrimer Gel-treated patients vs. 22% of placebo patients.
CONCLUSION


Astodrimer Gel once daily for 7 days was superior to placebo for treatment of bacterial vaginosis and was well-tolerated. The 1% dose consistently showed the strongest efficacy across endpoints. These results support a role for Astodrimer Gel, 1%, as an effective treatment for bacterial vaginosis.",2020,"Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]).","['bacterial vaginosis', '132 women with bacterial vaginosis']","['Gel or hydroxyethyl cellulose placebo gel', 'Astodrimer Gel', 'placebo']","['symptoms, acceptability and adverse events', 'efficacy and safety', 'clinical cure', 'Clinical cure rates', 'clinical cure rates', 'vaginal discharge and vaginal odor', 'clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5']","[{'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0063131', 'cui_str': 'hydroxyethyl cellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0235678', 'cui_str': 'Vaginal odor'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}]",132.0,0.559696,"Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]).","[{'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Waldbaum', 'Affiliation': ""Downtown Women's Health Care, Denver, CO, United States of America.""}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Schwebke', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Jeremy R A', 'Initials': 'JRA', 'LastName': 'Paull', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Clare F', 'Initials': 'CF', 'LastName': 'Price', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Edmondson', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castellarnau', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCloud', 'Affiliation': 'McCloud Consulting Group, Sydney, NSW, Australia.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Kinghorn', 'Affiliation': 'Royal Hallamshire and Sheffield Teaching Hospitals, Sheffield, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0232394']
35,32366577,The Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Blood Pressure Lowering on Cardiovascular Outcomes and All-Cause Mortality in Type 2 Diabetes.,"OBJECTIVE


To examine whether low baseline diastolic blood pressure (DBP) modifies the effects of intensive systolic blood pressure (SBP) lowering on cardiovascular outcomes in type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


The Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial (ACCORD BP), a two-by-two factorial randomized controlled trial, examined effects of SBP (<120 vs. <140 mmHg) and glycemic (HbA 1c  <6% vs. 7.0-7.9% [<42 vs. 53-63 mmol/mol]) control on cardiovascular events in T2DM ( N  = 4,731). We examined whether effects of SBP control on cardiovascular composite were modified by baseline DBP and glycemic control.
RESULTS


Intensive SBP lowering decreased the risk of the cardiovascular composite (hazard ratio [HR] 0.76 [95% CI 0.59-0.98]) in the standard glycemic arm but not in the intensive glycemic arm (HR 1.06 [95% CI 0.81-1.40]). Spline regression models relating the effects of the intervention on the cardiovascular composite across the range of baseline DBP did not show evidence of effect modification by low baseline DBP for the cardiovascular composite in the standard or intensive glycemic arms. The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
CONCLUSIONS


In persons with T2DM, intensive SBP lowering decreased the risk of cardiovascular composite end point irrespective of baseline DBP in the setting of standard glycemic control. Hence, low baseline DBP should not be an impediment to intensive SBP lowering in patients with T2DM treated with guideline-recommended standard glycemic control.",2020,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
","['Type 2 Diabetes', 'type 2 diabetes mellitus (T2DM']","['low baseline diastolic blood pressure (DBP', 'Intensive Blood Pressure Lowering', 'intensive SBP intervention', 'intensive systolic blood pressure (SBP) lowering', 'SBP control', 'SBP']","['cardiovascular events', 'risk of the cardiovascular composite (hazard ratio [HR', 'risk of cardiovascular composite', 'cardiovascular outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4274392', 'cui_str': 'Baseline diastolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0567952,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
","[{'ForeName': 'Olesya L', 'Initials': 'OL', 'LastName': 'Ilkun', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT srinivasan.beddhu@hsc.utah.edu.'}]",Diabetes care,['10.2337/dc19-2047']
36,32344176,Imagining a positive future reduces cortisol response to awakening and reactivity to acute stress.,"The positive influence of optimism on health is thought to be due in part to a reduced physiological response to stress, as manifested for instance in activity of hypothalamic-pituitary-adrenal (HPA) systems. Results of previous studies support the notion that dispositional optimism can influence diurnal cortisol secretion as well as cortisol reactivity. The aim of the present study was to examine whether induced optimism can similarly affect HPA activity and thereby potentially have beneficial health effects. We assigned 66 university students to either the Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises. Before and after the intervention, we assessed diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal. Effects of the BPS intervention were tested with repeated measures ANOVA (psychological outcomes) and multilevel regression (cortisol outcomes). The BPS intervention was associated with decreases in both the CAR and cortisol responses to acute stress. Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism. Within-person decreases in worrying were associated with decreased CARs, whereas both decreased worrying and increased PA were linked to attenuated stress reactivity. Results suggest that the BPS intervention can influence HPA axis reactivity, with effects on well-being variables likely mediating the process. More research is needed to determine longer-term neuroendocrine and health effects of such interventions in at-risk as well as healthy populations.",2020,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.",['66 university students to either the'],"['BPS intervention', 'Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises']","['optimism', 'CAR and cortisol responses', 'cortisol response', 'diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal', 'HPA axis reactivity', 'HPA activity', 'diurnal cortisol secretion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",66.0,0.0181314,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.","[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Nicolson', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: n.nicolson@maastrichtuniversity.nl.'}, {'ForeName': 'Madelon L', 'Initials': 'ML', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: madelon.peters@maastrichtuniversity.nl.'}, {'ForeName': 'Yvo M C', 'Initials': 'YMC', 'LastName': 'In den Bosch-Meevissen', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104677']
37,32344198,Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes.,"BACKGROUND


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


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


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


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


Research support and drug was provided by Satiogen Pharmaceuticals (San Diego, CA). AA, MC, and NFL report grants (AA- C-Sig P30DK84567, K23 DK114460; MC- NIH R01 DK67071; NFL- R01 DK057993) from the NIH. JR was supported by an Early Career Grant from Society for Endocrinology.",2020,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","['human obesity and diabetes', 'participants with obesity and diabetes', '307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a']","['placebo, IC-CBAS', 'conjugated bile acids', 'ileo-colonic delivery of conjugated BAs (IC-CBAS', 'FGF19', 'placebo']","['glucose homeostasis', 'weight loss', 'faecal BA', 'obesity and diabetes', 'postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0443599', 'cui_str': 'Conjugated bile acids'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",307.0,0.064704,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Calderon', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McRae', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Rievaj', 'Affiliation': 'University of Cambridge, UK; Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Inuk', 'Initials': 'I', 'LastName': 'Zandvakili', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Linker-Nord', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Gedulin', 'Affiliation': 'Satiogen Pharmaceuticals, San Diego, CA, United States.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Vella', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Acosta', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States. Electronic address: acosta.andres@mayo.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102759']
38,32348699,How short is too short? A randomised controlled trial evaluating short-term existential behavioural therapy for informal caregivers of palliative patients.,"BACKGROUND


Informal caregivers of palliative patients show higher levels of depression and distress compared with the general population. Fegg's (2013) existential behavioural therapy was shortened to two individual 1-h sessions (short-term existential behavioural therapy).
AIM


Testing the effectiveness of sEBT on psychological symptoms of informal caregivers in comparison with active control.
DESIGN


Randomised controlled trial.
SETTING/PARTICIPANTS


Informal caregivers of palliative in-patients.
METHODS


The primary outcome was depression; secondary outcomes were anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. General linear mixed models allow several measurements per participant and change over time. Reasons for declining the intervention were investigated by Rosenstock's Health Belief Model.
RESULTS


Overall inclusion rate was 41.0%. Data of 157 caregivers were available (63.1% females; mean age: 54.6 years, standard deviation (SD): 14.1); 127 participants were included in the main analysis. Participation in sEBT or active control was not significantly associated with post-treatment depression. Outcomes showed prevailingly significant association with time of investigation. Self-efficacy, scepticism of benefit of the intervention, belief of better coping alone and support by family and friends were significant factors in declining participation in the randomised controlled trial.
CONCLUSION


Inclusion rate was tripled compared with a previously evaluated longer EBT group intervention. By shortening the intervention, inclusion rate was traded for effectiveness and the intervention could not impact caregivers' psychological state. Early integration of sEBT and combination of individual and group setting and further study of the optimal length for caregiver interventions are suggested.",2020,Participation in sEBT or active control was not significantly associated with post-treatment depression.,"['Informal caregivers of palliative in-patients', 'informal caregivers in comparison with active control', '157 caregivers were available (63.1% females; mean age: 54.6\u2009years, standard deviation (SD): 14.1); 127 participants were included in the main analysis', 'informal caregivers of palliative patients', 'Informal caregivers of palliative patients']","['sEBT', 'short-term existential behavioural therapy']","['anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs', 'depression and distress']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",127.0,0.213714,Participation in sEBT or active control was not significantly associated with post-treatment depression.,"[{'ForeName': 'Martina B', 'Initials': 'MB', 'LastName': 'Kühnel', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Marchioro', 'Affiliation': 'Statistical Consulting Unit (StaBLab), Department of Statistics, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Deffner', 'Affiliation': 'Statistical Consulting Unit (StaBLab), Department of Statistics, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bausewein', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Seidl', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Center Munich, Neuherberg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Siebert', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fegg', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}]",Palliative medicine,['10.1177/0269216320911595']
39,32358862,"Effect of a 12-week endurance training program on force transfer and membrane integrity proteins in lean, obese, and type 2 diabetic subjects.","The mechanisms accounting for the loss of muscle function with obesity and type 2 diabetes are likely the result of a combination of neural and muscular factors. One muscular factor that is important, yet has received little attention, is the protein machinery involved in longitudinal and lateral force transmission. The purpose of this study was to compare the levels of force transfer and membrane integrity proteins before and after a 12-week endurance training program in lean, obese, and obese type 2 diabetic adults. Nineteen sedentary subjects (male = 8 and female = 11) were divided into three groups: Lean (n = 7; 50.3 ± 4.1 y; 69.1 ± 7.2 kg); Obese (n = 6; 49.8 ± 4.1 y; 92.9 ± 19.5 kg); and Obese with type 2 diabetes (n = 6; 51.5 ± 7.9 years; 88.9 ± 15.1 kg). Participants trained 150 min/week between 55% and 75% of VO 2max  for 12 weeks. Skeletal muscle biopsies were taken before and after the training intervention. Baseline dystrophin and muscle LIM protein levels were higher (~50% p < .01) in lean compared to obese and type 2 diabetic adults, while the protein levels of the remaining force transfer and membrane integrity proteins were similar between groups. After training, obese individuals decreased (-53%; p < .01) the levels of the muscle ankyrin repeat protein and lean individuals decreased dystrophin levels (-45%; p = .01), while the levels of the remaining force transfer and membrane integrity proteins were not affected by training. These results suggest that there are modest changes to force transfer and membrane integrity proteins in middle-aged individuals as a result of 12 weeks of lifestyle and training interventions.",2020,"After training, obese individuals decreased (-53%; p < .01)","['lean, obese, and obese type 2 diabetic adults', 'lean, obese, and type 2 diabetic subjects', 'Nineteen sedentary subjects (male\xa0=\xa08 and female\xa0=\xa011) were divided into three groups: Lean (n\xa0=\xa07; 50.3\xa0±\xa04.1 y; 69.1\xa0±\xa07.2\xa0kg); Obese (n\xa0=\xa06; 49.8\xa0±\xa04.1 y; 92.9\xa0±\xa019.5\xa0kg); and Obese with type 2 diabetes (n\xa0=\xa06; 51.5\xa0±\xa07.9\xa0years; 88.9\xa0±\xa015.1\xa0kg', 'middle-aged individuals']",['endurance training program'],"['dystrophin levels', 'Baseline dystrophin and muscle LIM protein levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0290137', 'cui_str': 'cysteine and glycine-rich protein 3'}]",19.0,0.0197282,"After training, obese individuals decreased (-53%; p < .01)","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Jannas-Vela', 'Affiliation': 'Exercise Physiology Laboratory, School of Kinesiology, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Henning T', 'Initials': 'HT', 'LastName': 'Langer', 'Affiliation': 'Department of Neurobiology, Physiology and Behavior, University of California, Davis, CA, USA.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Marambio', 'Affiliation': 'Centro de Salud Deportiva, Clinica Santa Maria, Santiago, Chile.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Baar', 'Affiliation': 'Department of Neurobiology, Physiology and Behavior, University of California, Davis, CA, USA.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Zbinden-Foncea', 'Affiliation': 'Exercise Physiology Laboratory, School of Kinesiology, Universidad Finis Terrae, Santiago, Chile.'}]",Physiological reports,['10.14814/phy2.14429']
40,32357897,Randomized control trial comparing an Alvarado Score-based management algorithm and current best practice in the evaluation of suspected appendicitis.,"BACKGROUND


An objective algorithm for the management of suspected appendicitis guided by the Alvarado Score had previously been proposed. This algorithm was expected to reduce computed tomography (CT) utilization without compromising the negative appendectomy rate. This study attempts to validate the proposed algorithm in a randomized control trial.
METHODS


A randomized control trial comparing the management of suspected acute appendicitis using the proposed algorithm compared to current best practice, with the rate of CT utilization as the primary outcome of interest. Secondary outcomes included the percentage of missed diagnosis, negative appendectomies, length of stay in days, and overall cost of stay in dollars.
RESULTS


One hundred sixty patients were randomized. Characteristics such as age, ethnic group, American Society of Anesthesiologist score, white cell count, and symptom duration were similar between the two groups. The overall CT utilization rate of the intervention arm and the usual care arm were similar (93.7% vs 92.5%, p = 0.999). There were no differences in terms of negative appendectomy rate, length of stay, and cost of stay between the intervention arm as compared to the usual care arm (p = 0.926, p = 0.705, and p = 0.886, respectively). Among patients evaluated with CT, 75% (112 out of 149) revealed diagnoses for the presenting symptoms.
CONCLUSION


The proposed AS-based management algorithm did not reduce the CT utilization rate. Outcomes such as missed diagnoses, negative appendectomy rates, length of stay, and cost of stay were also largely similar. CT utilization was prevalent as 93% of the study cohort was evaluated by CT scan.
TRIAL REGISTRATION


The study has been registered at ClinicalTrials.gov (NCT03324165, Registered October 27 2017).",2020,"There were no differences in terms of negative appendectomy rate, length of stay, and cost of stay between the intervention arm as compared to the usual care arm (p = 0.926, p = 0.705, and p = 0.886, respectively).","['suspected appendicitis', 'One hundred sixty patients were randomized']",['Alvarado Score-based management algorithm'],"['computed tomography (CT) utilization', 'missed diagnoses, negative appendectomy rates, length of stay, and cost of stay', 'overall CT utilization rate', 'CT utilization', 'negative appendectomy rate, length of stay, and cost of stay', 'percentage of missed diagnosis, negative appendectomies, length of stay in days, and overall cost of stay in dollars', 'CT utilization rate']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5197778', 'cui_str': 'Missing Diagnosis'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0562019', 'cui_str': 'dollar'}]",160.0,0.100051,"There were no differences in terms of negative appendectomy rate, length of stay, and cost of stay between the intervention arm as compared to the usual care arm (p = 0.926, p = 0.705, and p = 0.886, respectively).","[{'ForeName': 'Winson Jianhong', 'Initials': 'WJ', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore. winson.tan.j.h@singhealth.com.sg.'}, {'ForeName': 'Sanchalika', 'Initials': 'S', 'LastName': 'Acharyya', 'Affiliation': 'Clinical Research & Innovation Office, Tan Tock Seng Hospital Singapore, Singapore, Singapore.'}, {'ForeName': 'Min Hoe', 'Initials': 'MH', 'LastName': 'Chew', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore.'}, {'ForeName': 'Fung Joon', 'Initials': 'FJ', 'LastName': 'Foo', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore.'}, {'ForeName': 'Weng Hoong', 'Initials': 'WH', 'LastName': 'Chan', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Wai Keong', 'Initials': 'WK', 'LastName': 'Wong', 'Affiliation': 'Department of General Surgery, Sengkang General Hospital, Singapore, Singapore.'}, {'ForeName': 'London Lucien', 'Initials': 'LL', 'LastName': 'Ooi', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Jeremy Chung Fai', 'Initials': 'JCF', 'LastName': 'Ng', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hock Soo', 'Initials': 'HS', 'LastName': 'Ong', 'Affiliation': 'Department of General Surgery, Singapore General Hospital, Singapore, Singapore.'}]",World journal of emergency surgery : WJES,['10.1186/s13017-020-00309-0']
41,32342498,Efficacy of quadruple treatment on different types of pre-operative anaemia: secondary analysis of a randomised controlled trial.,"In patients with pre-operative anaemia undergoing cardiac surgery, combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12 and oral folic acid reduces allogeneic blood product transfusions. It is unclear if certain types of anaemia particularly benefit from this treatment. We performed a post-hoc analysis of anaemic patients from a randomised trial on the 'Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery'. We used linear regression analyses to examine the efficacy of a combination anaemia treatment compared with placebo on the following deficiencies, each representing a part of the combination treatment: ferritin and transferrin saturation; endogenous erythropoietin; holotranscobalamine; and folic acid in erythrocytes. Efficacy was defined as change in reticulocyte count from baseline to the first, third and fifth postoperative days and represented erythropoietic activity in the immediate peri-operative recovery phase. In all 253 anaemic patients, iron deficiency was the most common cause of anaemia. Treatment significantly increased reticulocyte count in all regression analyses on postoperative days 1, 3 and 5 (all p < 0.001). Baseline ferritin and endogenous erythropoietin were negatively associated with change in reticulocyte count on postoperative day 5, with an unstandardised regression coefficient B of -0.08 (95%CI -0.14 to -0.02) and -0.14 (95%CI -0.23 to -0.06), respectively. Quadruple anaemia treatment was effective regardless of the cause of anaemia and its effect manifested early in the peri-operative recovery phase. The more pronounced a deficiency was, the stronger the subsequent boost to erythropoiesis may have been.",2020,"Baseline ferritin and endogenous erythropoietin were negatively associated with change in reticulocyte count on postoperative day 5, with an unstandardised regression coefficient B of -0.08 (95%CI -0.14 to -0.02) and -0.14 (","['patients with pre-operative anaemia undergoing cardiac surgery, combination treatment with', '253 anaemic patients', 'patients with iron deficiency or anaemia undergoing cardiac surgery']","['intravenous iron, subcutaneous erythropoietin alpha, vitamin B12 and oral folic acid', 'ultra-short-term treatment', 'placebo']","['Efficacy', 'anaemia', 'erythropoietic activity', 'reticulocyte count', 'Baseline ferritin and endogenous erythropoietin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte count'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]",253.0,0.192155,"Baseline ferritin and endogenous erythropoietin were negatively associated with change in reticulocyte count on postoperative day 5, with an unstandardised regression coefficient B of -0.08 (95%CI -0.14 to -0.02) and -0.14 (","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rössler', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hegemann', 'Affiliation': 'Department of Medical Oncology and Haematology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Schoenrath', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Centre Berlin, German Centre for Cardiovascular Research, Berlin, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Seifert', 'Affiliation': 'Department of Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kaserer', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Spahn', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Falk', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Centre Berlin, German Centre for Cardiovascular Research, Berlin, Germany.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Spahn', 'Affiliation': 'Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}]",Anaesthesia,['10.1111/anae.15062']
42,32352644,Effects of Dapagliflozin on Epicardial Fat Thickness in Patients with Type 2 Diabetes and Obesity.,"OBJECTIVE


Epicardial adipose tissue (EAT) thickness is a marker of visceral fat and an emerging therapeutic target. Dapagliflozin, a selective sodium-glucose cotransporter 2 inhibitor, improves glucose control and induces moderate weight loss in patients with type 2 diabetes mellitus. Dapagliflozin has recently been shown to reduce cardiovascular risk. Nevertheless, whether dapagliflozin could reduce EAT thickness is unknown.
METHODS


This hypothesis was tested in a 24-week, randomized, double-blind, placebo-controlled clinical trial in 100 patients with type 2 diabetes mellitus with BMI ≥ 27 kg/m 2  and a hemoglobin A1c level ≤ 8% on metformin monotherapy. Individuals were randomly assigned to 2 groups to receive additional dapagliflozin up to 10 mg once daily or to remain on metformin up to 1,000 mg twice daily. Ultrasound-measured EAT thickness was measured at baseline, 12 weeks, and 24 weeks.
RESULTS


In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction. There was no statistically significant correlation between EAT and body weight changes.
CONCLUSIONS


Dapagliflozin causes a rapid and significant EAT reduction that could be independent of weight loss.",2020,"In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction.","['100 patients with type 2 diabetes mellitus with BMI\u2009≥\u200927 kg/m 2  and a hemoglobin A1c level\u2009≤\u20098% on', 'patients with type 2 diabetes mellitus', 'Patients with Type 2 Diabetes and Obesity']","['metformin monotherapy', 'dapagliflozin', 'metformin', 'additional dapagliflozin up to 10 mg once daily or to remain on metformin', 'Dapagliflozin', 'placebo']","['smaller EAT reduction', 'EAT', 'weight loss', 'moderate weight loss', 'EAT and body weight changes', 'Ultrasound-measured EAT thickness', 'EAT thickness', 'Epicardial Fat Thickness']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",100.0,0.062762,"In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gra-Menendez', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22798']
43,32349698,Mindfulness-based crisis interventions (MBCI) for psychosis within acute inpatient psychiatric settings; a feasibility randomised controlled trial.,"BACKGROUND


Inpatient psychiatric care is a scarce and expensive resource in the National Health Service (NHS), with chronic bed shortages being partly driven by high re-admission rates. Brief inpatient talking therapies for psychosis could help reduce re-admission rates. The primary aim was to assess feasibility and acceptability of a novel, brief, mindfulness-based intervention for inpatients with psychosis. The secondary aim was to collect pilot outcome data on readmission rate, at 6 and 12 months (m) post discharge, and self-report symptom measures at 6 m.
METHODS


The amBITION study (BrIef Talking therapIes ON wards) was a parallel group, feasibility randomised controlled trial (RCT). In addition to treatment as usual (TAU), eligible inpatients with psychotic symptoms were randomly allocated to receive either (Mindfulness-Based Crisis Intervention; MBCI) or a control intervention (Social Activity Therapy; SAT), for 1-5 sessions.
RESULTS


Fifty participants were recruited (26 MBCI; 24 SAT); all received at least 1 therapy session (mean = 3). Follow-up rates were 98% at 6 m and 96% at 12 m for service use data extracted from clinical notes, and 86% for self-report measures. At 6 m follow-up, re-admission rates were similar across groups (MBCI = 6, SAT = 5; odds ratio = 1.20, 95% CI: 0.312-4.61). At 12 m follow-up, re-admissions were lower in the MBCI group (MBCI = 7, SAT = 11; odds ratio = 0.46, 95% CI: 0.14-1.51). Three participants experienced adverse events; none was related to trial participation.
CONCLUSIONS


Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission. These promising findings warrant progression to a larger clinical effectiveness trial.
TRIAL REGISTRATION


ISRCTN37625384.",2020,"Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission.","['psychosis within acute inpatient psychiatric settings', 'inpatients with psychosis', 'Fifty participants were recruited (26 MBCI; 24 SAT', 'eligible inpatients with psychotic symptoms']","['control intervention (Social Activity Therapy; SAT', 'Mindfulness-Based Crisis Intervention; MBCI', 'Mindfulness-based crisis interventions (MBCI', 'mindfulness-based intervention']","['feasibility and acceptability', 're-admission rates', 'adverse events', 'readmission rate, at 6 and 12\u2009months (m) post discharge, and self-report symptom measures']","[{'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150123', 'cui_str': 'Activity care'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010332', 'cui_str': 'Crisis intervention'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",50.0,0.156213,"Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission.","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK. pcj25@bath.ac.uk.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Robinson', 'Affiliation': ""Department of Biostatistics & Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chadwick', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK.""}]",BMC psychiatry,['10.1186/s12888-020-02608-x']
44,32353963,The Effects of Long-Term 40-Hz Physioacoustic Vibrations on Motor Impairments in Parkinson's Disease: A Double-Blinded Randomized Control Trial.,"Recent studies have suggested that vibration therapy may have a positive influence in treating motor symptoms of Parkinson's disease (PD). However, quantitative evidence of the benefits of vibration utilized inconsistent methods of vibration delivery, and to date there have been no studies showing a long-term benefit of 40 Hz vibration in the PD population. The objective of this study was to demonstrate the efficacy of vibration administered via a physioacoustic therapy method (PAT) on motor symptoms of PD over a longer term, completed as a randomized placebo-controlled trial. Overall motor symptom severity measured by the Unified Parkinson's Disease Rating Scale III showed significant improvements in the treatment group over 12 weeks. Specifically, all aspects of PD, including tremor, rigidity, bradykinesia, and posture and gait measures improved. To our knowledge, this is the first study to quantitatively assess 40-Hz vibration applied using the PAT method for potential long-term therapeutic effects on motor symptoms of PD.",2020,Overall motor symptom severity measured by the Unified Parkinson's Disease Rating Scale III showed significant improvements in the treatment group over 12 weeks.,"[""Parkinson's Disease""]","['placebo', 'Long-Term 40-Hz Physioacoustic Vibrations', 'vibration therapy', 'vibration administered via a physioacoustic therapy method (PAT']","['Motor Impairments', ""Unified Parkinson's Disease Rating Scale"", 'Overall motor symptom severity', 'motor symptoms of PD', 'tremor, rigidity, bradykinesia, and posture and gait measures improved']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.1781,Overall motor symptom severity measured by the Unified Parkinson's Disease Rating Scale III showed significant improvements in the treatment group over 12 weeks.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mosabbir', 'Affiliation': 'Faculty of Music, University of Toronto, Toronto, ON M5S 2C5, Canada.'}, {'ForeName': 'Quincy J', 'Initials': 'QJ', 'LastName': 'Almeida', 'Affiliation': 'Movement Disorders Research and Rehabilitation Centre, Faculty of Science, Wilfrid Laurier University, Waterloo, ON N2L 3C5, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Ahonen', 'Affiliation': 'Manfred and Penny Conrad Institute for Music Therapy Research, Faculty of Music, Wilfrid Laurier University, Waterloo, ON N2L 3C5, Canada.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020113']
45,32358262,Comparison of visual and refractive outcomes of 2 trifocal intraocular lenses.,"PURPOSE


To compare clinical outcomes after cataract surgery and bilateral implantation of 2 diffractive trifocal toric intraocular lenses (IOLs).
SETTING


Hospital da Luz, Lisbon, Portugal.
DESIGN


Double-arm, randomized, prospective case series.
METHODS


A total of 60 patients were randomly allocated to receive bilateral implantation of either the FineVision Pod FT toric IOL (PhysIOL) or the AcrySof IQ PanOptix toric IOL (Alcon). Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire) were evaluated at 3 months postoperatively. Surgically induced astigmatic changes were evaluated by vector analysis.
RESULTS


Each group (FineVision toric and AcrySof IQ PanOptix toric) comprised 30 patients (60 eyes). No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333). Mean postoperative distance-corrected intermediate visual acuity at 60 cm was 0.04 ± 0.09 logarithm of the minimum angle of resolution (logMAR) and 0.09 ± 0.11 logMAR in the PanOptix and Pod FT group, respectively (P = .032). Mean IOL axis misalignment was 1.59 degrees ± 2.15 degrees (PanOptix group) and 1.89 degrees ± 3.31 degrees (Pod FT group) (P = .821). Mean magnitude of error of astigmatic correction was -0.09 diopters (D) and -0.11 D in the PanOptix group and Pod FT group, respectively (P = .333). Contrast sensitivity, QoV scores for the presence of photic phenomena, and the level of spectacle independence were similar in both groups (P > .05).
CONCLUSIONS


Both trifocal toric IOLs allowed complete patient visual restoration, and good spectacle independence and good visual quality outcomes. The PanOptix IOL provided superior intermediate visual acuity for distances around 60 cm.",2020,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333).,"['30 patients (60 eyes', 'Hospital da Luz, Lisbon, Portugal', '60 patients']","['2 trifocal intraocular lenses', 'cataract surgery and bilateral implantation of 2 diffractive trifocal toric intraocular lenses (IOLs', 'bilateral implantation of either the FineVision Pod FT toric IOL (PhysIOL) or the AcrySof IQ PanOptix toric IOL (Alcon']","['Mean IOL axis misalignment', 'Mean magnitude of error of astigmatic correction', 'Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire', 'corrected distance and near visual outcomes', 'Contrast sensitivity, QoV scores', 'astigmatic changes', 'Mean postoperative distance-corrected intermediate visual acuity', 'complete patient visual restoration, and good spectacle independence and good visual quality outcomes', 'level of spectacle independence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0784492,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333).,"[{'ForeName': 'Filomena J', 'Initials': 'FJ', 'LastName': 'Ribeiro', 'Affiliation': 'From the Department of Ophthalmology, Hospital da Luz, Lisbon, Portugal.'}, {'ForeName': 'Tiago B', 'Initials': 'TB', 'LastName': 'Ferreira', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000118']
46,32358267,Influence of angle κ on visual and refractive outcomes after implantation of a diffractive trifocal intraocular lens.,"PURPOSE


To evaluate changes in angle κ after the implantation of a trifocal intraocular lens (IOL) and to assess the postoperative outcomes of patients with different angle κ values.
SETTING


IOA Madrid Innova Ocular, Madrid, Spain.
DESIGN


Prospective trial.
METHODS


Sixty-three eyes from 63 patients who had bilateral implantation of a diffractive trifocal IOL (POD F, PhysIOL) were included. Pupil offset was used as the best estimate of angle κ and was measured using Pentacam (Oculus) preoperatively and at 3 months postoperatively. Postoperative refractive outcomes (sphere, cylinder, and manifest refraction spherical equivalent) and visual outcomes at far, intermediate, and near distance were assessed and compared between eyes with small pupil offset and eyes with large pupil offset. Quality of vision was assessed using a subjective questionnaire.
RESULTS


There was a significant decrease in pupil offset values postoperatively (mean: 0.197 ± 0.12 mm) compared with those preoperatively (mean: 0.239 ± 0.12 mm), with a mean decrease of -0.042 mm (P = .0002). The same significant decrease was found for both right and left eyes, when analyzed separately. No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset. The majority of patients (14 of 16) complaining of significant halos had eyes with small pupil offset.
CONCLUSIONS


Large pupil offset did not negatively affect visual and refractive outcomes. The tolerance to larger pupil offset might be due to the IOL optical design, with the first diffractive ring being larger than other commonly used multifocal IOLs. More studies comparing various diffractive IOL models would be useful to confirm such hypothesis.",2020,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"['IOA Madrid Innova Ocular, Madrid, Spain', 'Sixty-three eyes from 63 patients who had bilateral implantation of a diffractive trifocal IOL (POD F, PhysIOL) were included', 'patients with different angle κ values']",['trifocal intraocular lens (IOL'],"['Postoperative refractive outcomes (sphere, cylinder, and manifest refraction spherical equivalent) and visual outcomes at far, intermediate, and near distance', 'visual and refractive outcomes', 'pupil offset values', 'Quality of vision', 'refractive and visual acuity outcomes']","[{'cui': 'C0648637', 'cui_str': 'isooctyl acrylate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",63.0,0.0391853,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garzón', 'Affiliation': 'From the IOA Madrid Innova Ocular (Garzón, López-Artero, Poyales); Department of Optica II, Complutense University, Madrid (Garzón, García-Montero); Clínica Oftalmológica Dr Gonzalo Muñoz, Valencia (Albarrán-Diego); Department of Ophthalmology (Oftalmar), Vithas Medimar International Hospital, Alicante (Pérez-Cambrodí); and Begitek, Innova Ocular (Illarramendi), Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'García-Montero', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'López-Artero', 'Affiliation': ''}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Albarrán-Diego', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez-Cambrodí', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Illarramendi', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Poyales', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000156']
47,32361755,Evaluation of the effect of UGT1A1 polymorphisms on the pharmacokinetics of oral and long-acting injectable cabotegravir.,"BACKGROUND


Cabotegravir is an HIV integrase inhibitor in clinical development with both oral and long-acting (LA) injectable formulations. Cabotegravir is primarily metabolized by uridine 5'-diphospho-glucuronosyltransferase (UGT) 1A1, a known polymorphic enzyme with functional variants that can affect drug metabolism and exposure.
OBJECTIVES


To investigate the pharmacogenetic effects of the reduced-function alleles UGT1A1*6, UGT1A1*28 and/or UGT1A1*37 on steady-state pharmacokinetics (PK) and safety of oral cabotegravir (30 mg/day) and intramuscular cabotegravir LA (400 mg every 4 weeks or 600 mg every 8 weeks).
METHODS


Plasma cabotegravir PK was assessed in 346 UGT-genotyped participants with and without UGT1A1 functional variants across six studies (four Phase I and two Phase II) of oral cabotegravir, including 215 HIV-infected participants who received oral cabotegravir followed by cabotegravir LA. Changes from baseline in total bilirubin and ALT were assessed in one study (LATTE; NCT01641809).
RESULTS


Statistically significant (P < 0.05) associations were observed between UGT1A1 genotype and plasma cabotegravir PK parameters, with 28%-50% increases following oral cabotegravir [plasma cabotegravir concentration at the end of the dosing interval (Ctau), 1.50-fold; AUCtau, 1.41-fold; and Cmax, 1.28-fold] and 16%-24% increases following cabotegravir LA administration (48 week Ctau, 1.24-fold; AUCtau, 1.16-fold; and Cmax, 1.18-fold) among those with low-versus-normal genetically predicted UGT1A1 activity. A statistically significant (P < 10-5) association between predicted UGT1A1 activity and maximum change in total bilirubin was also observed (2.45-fold asymptomatic increase for low versus normal) without a corresponding change in ALT.
CONCLUSIONS


This modest increase in oral and parenteral cabotegravir exposure associated with a reduced function of UGT1A1 is not considered clinically relevant based on accumulated safety data; no dose adjustment is required.",2020,"RESULTS


Statistically significant (P < 0.05) associations were observed between UGT1A1 genotype and plasma cabotegravir PK parameters, with 28%-50% increases following oral cabotegravir [plasma cabotegravir concentration at the end of the dosing interval (Ctau), 1.50-fold; AUCtau, 1.41-fold; and Cmax, 1.28-fold] and 16%-24% increases following cabotegravir LA administration (48 week Ctau, 1.24-fold; AUCtau, 1.16-fold; and Cmax, 1.18-fold) among those with low-versus-normal genetically predicted UGT1A1 activity.","['346 UGT-genotyped participants with and without UGT1A1 functional variants across six studies (four Phase I and two Phase II) of oral cabotegravir, including 215 HIV-infected participants who received']","['UGT1A1', 'oral cabotegravir followed by cabotegravir LA', 'oral cabotegravir (30\u2009mg/day) and intramuscular cabotegravir LA (400\u2009mg']","['oral cabotegravir [plasma cabotegravir concentration', 'UGT1A1 activity and maximum change in total bilirubin', 'steady-state pharmacokinetics (PK) and safety', 'UGT1A1 genotype and plasma cabotegravir PK parameters', 'total bilirubin and ALT']","[{'cui': 'C0643869', 'cui_str': ""uridine 5'-(phosphoimidazolate)""}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C1567723', 'cui_str': 'UGT1A1 protein, human'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1567723', 'cui_str': 'UGT1A1 protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1567723', 'cui_str': 'UGT1A1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.115334,"RESULTS


Statistically significant (P < 0.05) associations were observed between UGT1A1 genotype and plasma cabotegravir PK parameters, with 28%-50% increases following oral cabotegravir [plasma cabotegravir concentration at the end of the dosing interval (Ctau), 1.50-fold; AUCtau, 1.41-fold; and Cmax, 1.28-fold] and 16%-24% increases following cabotegravir LA administration (48 week Ctau, 1.24-fold; AUCtau, 1.16-fold; and Cmax, 1.18-fold) among those with low-versus-normal genetically predicted UGT1A1 activity.","[{'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': 'PAREXEL International, Durham, NC, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'King', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Parham', 'Affiliation': 'PAREXEL International, Durham, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ford', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kalpana K', 'Initials': 'KK', 'LastName': 'Bakshi', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Sutton', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Arlene R', 'Initials': 'AR', 'LastName': 'Hughes', 'Affiliation': 'PAREXEL International, Durham, NC, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Spreen', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa147']
48,32362238,"Two-year weight, risk and health factor outcomes of a weight-reduction intervention programme: Primary prevention for overweight in a multicentre primary healthcare setting.","Objective:  To study the long-term effects of weight reduction, quality of life and sense of coherence in a primary health care (PHC)-based programme with two different intensities. Design:  Prospective two-armed randomised intervention. Setting:  Three PHC centres in south west of Sweden. Subjects:  In total, 289 women and men aged 40-65 years with a BMI of 28-35 were recruited for a two-year weight-reduction programme. Participants were randomized to high-intensity or low-intensity groups. Blood samples, physical measurements and questionnaires were analysed. Participants received cookbooks and dietary lectures. The high-intensity group also received Motivational interviewing (MI), dietary advice on prescription (DAP- advice), a grocery store lecture, a website and weekly e-mails. Main outcome measures:  Weight, quality of life, risks and health factors. Results:  In total, 182 (64%) participants completed the 2-year follow-up. The total sample reduced their weight by 1 kg ( p  = 0.006). No significant differences regarding weight were found between the groups. Anxiety/depression decreased in EQ5-D ( p  = 0.021), EQ5-D VAS ( p  = 0.002) and SOC ( p  = 0.042). Between the groups, there were significant differences in EQ5-D usual activities ( p  = 0.004), anxiety/depression ( p  = 0.013), pain/discomfort  (p =  0.041), fruit and vegetables ( p  = 0.005), HLV anxiety ( p  = 0.005), and visits to nurses ( p  = 0.012). Conclusion:  The total population lost weight, and the high-intensity and low-intensity programmes did not result in significant differences in terms of weight. The high-intensity programme reported health benefits linked to lower levels of anxiety and depression, increased activity and intake of greens and reduced visits to physicians and nurses.Key pointsBoth groups had a consisting weight- reduction after two years.High intensity did not lead to a significant difference in weight reduction between the groups.The high-intensity group reported more health effects, such as better quality of life, reduced anxiety, and increased greenery intake. It is unknown how much support patients in a weight- reduction programme in PHC require to succeed with weight loss and a healthy lifestyle.",2020,"Between the groups, there were significant differences in EQ5-D usual activities ( p  = 0.004), anxiety/depression ( p  = 0.013), pain/discomfort  (p =  0.041), fruit and vegetables ( p  = 0.005), HLV anxiety ( p  = 0.005), and visits to nurses ( p  = 0.012).","['Subjects', '289 women and men aged 40-65\u2009years with a BMI of 28-35 were recruited for a two-year weight-reduction programme', 'Setting:  Three PHC centres in south west of Sweden']","['weight-reduction intervention programme', 'Motivational interviewing (MI), dietary advice on prescription (DAP- advice', 'cookbooks and dietary lectures']","['Weight, quality of life, risks and health factors', 'EQ5-D usual activities', 'weight', 'HLV anxiety', 'Anxiety/depression decreased in EQ5-D', 'health effects', 'quality of life, reduced anxiety, and increased greenery intake', 'weight reduction, quality of life and sense of coherence', 'pain/discomfort', 'fruit and vegetables', 'weight reduction', 'anxiety/depression', 'EQ5-D VAS', 'total population lost weight', 'Blood samples, physical measurements and questionnaires']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0376294', 'cui_str': 'Cookbooks'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",289.0,0.038323,"Between the groups, there were significant differences in EQ5-D usual activities ( p  = 0.004), anxiety/depression ( p  = 0.013), pain/discomfort  (p =  0.041), fruit and vegetables ( p  = 0.005), HLV anxiety ( p  = 0.005), and visits to nurses ( p  = 0.012).","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bräutigam-Ewe', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lydell', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Bergh', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Hildingh', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Baigi', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Månsson', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1753379']
49,32357152,Effects of antenatal hypnosis on maternal salivary cortisol during childbirth and six weeks postpartum-A randomized controlled trial.,"BACKGROUND


Cortisol has been used to capture psychophysiological stress during childbirth and postpartum wellbeing. We explored the effect of a brief antenatal training course in self-hypnosis on salivary cortisol during childbirth and 6 weeks postpartum.
METHODS


In a randomized, controlled trial conducted at Aarhus University Hospital Skejby Denmark during the period January 2010 until October 2010, a total of 349 healthy nulliparous women were included. They were randomly allocated to a hypnosis group (n = 136) receiving three one-hour lessons in self-hypnosis with additional audio-recordings, a relaxation group (n = 134) receiving three one-hour lessons in various relaxation methods with audio-recordings for additional training, and a usual care group (n = 79) receiving ordinary antenatal care only. Salivary cortisol samples were collected during childbirth (at the beginning of the pushing state, 30 minutes, and 2 hours after childbirth), and 6 weeks postpartum (at wake up, 30 minutes after wake up, and evening). Cortisol concentrations were compared using a linear mixed-effects model. Correlations between cortisol concentrations and length of birth, experienced pain and calmness during birth were examined by a Spearman rank correlation test.
FINDINGS


During childbirth, week correlations were found between cortisol concentrations 30 minutes after childbirth and length of birth. In the beginning of the pushing state and 2 hours after childbirth, we found a tendency towards higher cortisol concentrations in the hypnosis group compared to the other two groups (hypnosis versus relaxation p = 0.02 and 0.03, hypnosis versus usual care p = 0.08 and 0.05). No differences were observed in cortisol concentrations between the groups 30 minutes after childbirth (hypnosis versus relaxation p = 0.08, hypnosis versus usual care 0.10) or 6 weeks postpartum (hypnosis versus relaxation: p = 0.85, 0.51, and 0.68, hypnosis versus usual care: p = 0.85, 0.93, and 0.96).
CONCLUSION


Antenatal hypnosis training may increase the release of cortisol during childbirth with no long-term consequences. Further research is needed to help interpret these findings.",2020,"No differences were observed in cortisol concentrations between the groups 30 minutes after childbirth (hypnosis versus relaxation p = 0.08, hypnosis versus usual care 0.10) or 6 weeks postpartum (hypnosis versus relaxation: p = 0.85, 0.51, and 0.68, hypnosis versus usual care: p = 0.85, 0.93, and 0.96).
","['at Aarhus University Hospital Skejby Denmark during the period January 2010 until October 2010, a total of 349 healthy nulliparous women were included']","['Antenatal hypnosis training', 'antenatal hypnosis', 'hypnosis group (n = 136) receiving three one-hour lessons in self-hypnosis with additional audio-recordings, a relaxation group (n = 134) receiving three one-hour lessons in various relaxation methods with audio-recordings for additional training, and a usual care group (n = 79) receiving ordinary antenatal care only']","['Salivary cortisol samples', 'cortisol concentrations and length of birth, experienced pain and calmness during birth', 'release of cortisol during childbirth', 'Cortisol concentrations', 'cortisol concentrations', 'maternal salivary cortisol']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",349.0,0.0956058,"No differences were observed in cortisol concentrations between the groups 30 minutes after childbirth (hypnosis versus relaxation p = 0.08, hypnosis versus usual care 0.10) or 6 weeks postpartum (hypnosis versus relaxation: p = 0.85, 0.51, and 0.68, hypnosis versus usual care: p = 0.85, 0.93, and 0.96).
","[{'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Werner', 'Affiliation': 'Institute of Clinical Research, Research Unit of Gynecology and Obstetrics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Chunsen', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Institute of Clinical Research, Research Unit of Gynecology and Obstetrics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zachariae', 'Affiliation': 'Department of Oncology, Unit for Psychooncology and Health Psychology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ellen A', 'Initials': 'EA', 'LastName': 'Nohr', 'Affiliation': 'Institute of Clinical Research, Research Unit of Gynecology and Obstetrics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Uldbjerg', 'Affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Åse Marie', 'Initials': 'ÅM', 'LastName': 'Hansen', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0230704']
50,32362510,Cluster Randomized Trial of a College Health Center Sexual Violence Intervention.,"INTRODUCTION


Sexual violence, particularly in the context of drinking, is prevalent on college campuses. This study tested a brief intervention to prevent sexual violence among students receiving care from college health centers.
STUDY DESIGN


This study was a two-arm, unblinded cluster RCT.
SETTING/PARTICIPANTS


On 28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers completed surveys before the appointment, immediately after, 4 months later, and 12 months later.
INTERVENTION


Intervention college health center staff received training on delivering sexual violence education to all students seeking care. Control sites provided information about drinking responsibly.
MAIN OUTCOME MEASURES


The primary outcome was students' change in recognition of sexual violence. Additional outcomes included sexual violence disclosure and use of services among students with a history of sexual violence at baseline. Generalized linear mixed models accounting for campus-level clustering assessed intervention effects. Data were analyzed from September 2018 to June 2019.
RESULTS


Half (55%) of students seeking care at college health centers reported any history of sexual violence exposure. No between-group differences in primary (β=0.001, 95% CI= -0.04, 0.04) or secondary outcomes emerged between intervention and control students. Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants. Among those who reported sexual violence at baseline, intervention students had increased odds of disclosing violence during the visit (AOR=4.47, 95% CI=2.25, 8.89) in intensity-adjusted analyses compared with control. No between-group differences emerged for remaining outcomes.
CONCLUSIONS


Sexual violence exposure is high among students seeking care in college health centers. A brief provider-delivered sexual violence intervention, when implemented with fidelity, was associated with improved self-efficacy to use harm reduction and increased disclosure of sexual violence during clinical encounters but no increased use of services. More interventions that are stronger in intensity are needed to connect students to sexual violence services.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02355470.",2020,"Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants.","['Data were analyzed from September 2018 to June 2019', 'students seeking care in college health centers', 'students receiving care from college health centers', '28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers', 'College Health Center Sexual Violence Intervention']","['Intervention college health center staff received training on delivering sexual violence education to all students seeking care', 'sexual violence intervention']","[""students' change in recognition of sexual violence"", 'disclosing violence', 'sexual violence disclosure and use of services among students with a history of sexual violence', 'history of sexual violence exposure', 'self-efficacy', 'disclosure of sexual violence', 'sexual violence']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",2291.0,0.0525815,"Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Electronic address: elizabeth.miller@chp.edu.""}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'McCauley', 'Affiliation': 'School of Social Work, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Rofey', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Psychiatry, Western Psychiatric Hospital, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Duncan B', 'Initials': 'DB', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Talis', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Jocelyn C', 'Initials': 'JC', 'LastName': 'Anderson', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; College of Nursing, Pennsylvania State University, State College, Pennsylvania.""}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Chugani', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Robert W S', 'Initials': 'RWS', 'LastName': 'Coulter', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Behavioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.007']
51,32362175,"Personalized text message and checklist support for initiation of antihypertensive medication: the cluster randomized, controlled check and support trial.","Objective:  To assess whether the use of a checklist combined with text message support improves systolic blood pressure (SBP) control. Design and setting:  A cluster randomized controlled trial in Finnish primary care. Interventions:  Personalized text message support and a checklist for initiation of antihypertensive medication. Patients:  111 newly diagnosed hypertensive patients aged 30-75 years. Main outcome measures:  The proportion of patients achieving 1) the office SBP target <140 mmHg or 2) the home SBP target <135 mmHg at 12 months. Results:  28% ( n  = 16) and 31% ( n  = 17) of patients in the intervention and control groups met the office SBP target, respectively ( p  = 0.51). The corresponding proportions were 36% ( n  = 18) and 42% ( n  = 21) for the home SBP target ( p  = 0.21). Office SBP decreased 23 mmHg (95% CI: 29-17) in the intervention group and 21 mmHg (95% CI: 27-15) in the control group ( p  = 0.61). Medication changes, number of antihypertensives at 12 months and health care utilization were similar in both study groups. Patients considered checklist and text message support useful and important. Conclusion:  Only a small proportion of patients in the intervention and control groups reached their treatment target despite multiple health care contacts and medication changes. The study interventions did not improve SBP control. However, this study demonstrates new information about hypertension control, antihypertensive medication and health service utilization during the first treatment year.",2020,Office SBP decreased 23 mmHg (95% CI: 29-17) in the intervention group and 21 mmHg (95% CI: 27-15) in the control group ( p  = 0.61).,"['Patients:  111 newly diagnosed hypertensive patients aged 30-75\u2009years', 'Finnish primary care']","['checklist combined with text message support', 'antihypertensive medication']","['SBP control', 'proportion of patients achieving 1) the office SBP target <140\u2009mmHg or 2) the home SBP', 'systolic blood pressure (SBP) control', 'Medication changes, number of antihypertensives at 12\u2009months and health care utilization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",,0.059699,Office SBP decreased 23 mmHg (95% CI: 29-17) in the intervention group and 21 mmHg (95% CI: 27-15) in the control group ( p  = 0.61).,"[{'ForeName': 'Aapo', 'Initials': 'A', 'LastName': 'Tahkola', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Korhonen', 'Affiliation': 'University of Turku, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Medcare Oy, Espoo, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Niiranen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Mäntyselkä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1753380']
52,32372290,Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus.,"INTRODUCTION


The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials.
METHODS


Pooled data from 20 trials were analyzed for patients with T2DM treated with empagliflozin 10 mg (n = 4858), empagliflozin 25 mg (n = 5057), or placebo (n = 4904). The dataset comprised 15 randomized phase I-III trials, an extension trial and dose escalation studies. Adverse events (AEs) were assessed descriptively in participants who took ≥ 1 dose of study drug. AE incidence rates per 100 patient-years were calculated to adjust for differences in drug exposure between trials.
RESULTS


Total exposure was 16,480 and 7857 patient-years in the pooled empagliflozin 10/25 mg and placebo groups, respectively. The incidence of any AEs, AEs leading to treatment discontinuation, severe AEs, and serious AEs was similar across groups. The frequency of serious AEs requiring hospitalization was 18.6% for the empagliflozin 10/25 mg group and 21.3% for the placebo group. The empagliflozin 10/25 mg group was not associated with a higher rate of confirmed hypoglycemia versus placebo, except in patients co-administered insulin and/or a sulfonylurea (31.5% vs. 30.2%, respectively). The incidence of events consistent with urinary tract infections (UTI) was also similar for the empagliflozin 10/25 mg group versus placebo (9.27 vs. 9.70/100 patient-years, respectively). History of UTI was identified as a risk factor for UTI during treatment. Events consistent with genital infections occurred more frequently with empagliflozin 10/25 mg than placebo (3.54 vs. 0.95/100 patient-years, respectively). The frequency of AEs consistent with volume depletion was similar across groups, but higher with empagliflozin 10/25 mg than placebo in patients aged 75 to < 85 years and those on loop diuretics at baseline.
CONCLUSION


This comprehensive analysis confirms that both empagliflozin 10 mg and 25 mg are well tolerated in patients with T2DM, reinforcing the established clinical safety profile of empagliflozin.",2020,Events consistent with genital infections occurred more frequently with empagliflozin,"['10\xa0mg (n\u2009=\u20094858', 'Total exposure was 16,480 and 7857 patient-years in the pooled', 'Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM', 'Pooled data from 20 trials were analyzed for patients with T2DM treated with', 'patients with T2DM']","['empagliflozin 25\xa0mg (n\u2009=\u20095057), or placebo', 'Empagliflozin', 'empagliflozin', 'placebo']","['AE incidence rates', 'genital infections', 'higher rate of confirmed hypoglycemia', 'safety and tolerability', 'incidence of any AEs, AEs leading to treatment discontinuation, severe AEs, and serious AEs', 'Adverse events (AEs', 'incidence of events consistent with urinary tract infections (UTI', 'frequency of AEs consistent with volume depletion', 'frequency of serious AEs requiring hospitalization']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0729552', 'cui_str': 'Genital infection'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.314442,Events consistent with genital infections occurred more frequently with empagliflozin,"[{'ForeName': 'Ona', 'Initials': 'O', 'LastName': 'Kinduryte Schorling', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Hristo', 'Initials': 'H', 'LastName': 'Iliev', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany. hristo.iliev@boehringer-ingelheim.com.'}]",Advances in therapy,['10.1007/s12325-020-01329-7']
53,32365675,"Correction: Sartorius et al. ""Postprandial Effects of a Proprietary Milk Protein Hydrolysate Containing Bioactive Peptides in Prediabetic Subjects""  Nutrients  2019 , 11,  1700.","Milk proteins have been hypothesized to protect against type 2 diabetes (T2DM) by beneficially modulating glycemic response, predominantly in the postprandial status. This potential is, amongst others, attributed to the high content of whey proteins, which are commonly a product of cheese production. However, native whey has received substantial attention due to its higher leucine content, and its postprandial glycemic effect has not been assessed thus far in prediabetes. In the present study, the impact of a milk protein hydrolysate of native whey origin with alpha-glucosidase inhibiting properties was determined in prediabetics in a randomized, cross-over trial. Subjects received a single dose of placebo or low- or high-dosed milk protein hydrolysate prior to a challenge meal high in carbohydrates. Concentration-time curves of glucose and insulin were assessed. Incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by low-dosed milk peptides compared to placebo (p = 0.0472), and a minor insulinotropic effect was seen. A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA1c values (p = 0.0244). In conclusion, the current milk protein hydrolysate of native whey origin has the potential to modulate postprandial hyperglycemia and hence may contribute in reducing the future risk of developing T2DM.",2020,A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA1c values (p = 0.0244).,"['Prediabetic Subjects""  Nutrients  2019 , 11,  1700']","['placebo', 'milk protein hydrolysate', 'placebo or low- or high-dosed milk protein hydrolysate', 'Proprietary Milk Protein Hydrolysate Containing Bioactive Peptides']","['glucose response', 'Incremental areas under the curve (iAUC) of glucose', 'Concentration-time curves of glucose and insulin', 'insulinotropic effect']","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0172105,A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA1c values (p = 0.0244).,"[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sartorius', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Weidner', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Tanita', 'Initials': 'T', 'LastName': 'Dharsono', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Boulier', 'Affiliation': 'Ingredia S.A., 51 Avenue F. Lobbedez CS 60946, 62033 Arras CEDEX, France.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Mathematics, Natural and Economic Sciences, Ulm University of Applied Sciences, Albert-Einstein-Allee 55, 89081 Ulm, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Schön', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}]",Nutrients,['10.3390/nu12051266']
54,32366156,"Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes.","OBJECTIVES


Fixed-dose combination (FDC) therapy can improve outcomes in type 2 diabetes (T2D). We evaluated the bioequivalence of 2 doses of an FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor, versus corresponding free tablet combinations.
METHODS


Two randomized, open-label, two-way crossover studies in healthy adults compared: 2 FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR 1000 mg (Study 1; N = 30), 1 FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR 1000 mg (Study 2; N = 30) versus corresponding dose of free combinations. Subjects received study medication under fed conditions; washout was ≥35 days between treatments. Primary endpoints: area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72 hours for linagliptin, and peak plasma concentration (C max ) for empagliflozin, linagliptin, and metformin. Bioequivalence was defined as adjusted geometric mean ratios (FDC: free combination) and two-sided 90% confidence intervals (CIs) of AUC and C max  for each component within 80.00-125.00%.
RESULTS


Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively. Study 2: 29/29 treated participants were included in the pharmacokinetic analysis for both periods. The adjusted geometric mean ratios of FDCs to their respective free tablet combinations and two-sided 90% CIs were all within the predefined range. The shapes of the mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR were similar for subjects in the FDC and free combination groups in both studies. No serious adverse events were reported.
CONCLUSION


The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D.",2020,The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations.,"['healthy adults compared: 2', 'adults with T2D', 'Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively', 'patients with type 2 diabetes']","['empagliflozin/linagliptin/metformin XR FDC tablets', 'empagliflozin, linagliptin, and metformin', 'Triple fixed-dose combination empagliflozin, linagliptin, and metformin', 'FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor', 'FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR', 'FDC) therapy', 'FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR']","['area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72\xa0hours for linagliptin, and peak plasma concentration (C max ', 'adjusted geometric mean ratios of FDCs', 'mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR', 'serious adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3871442', 'cui_str': 'linagliptin and empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C4050744', 'cui_str': 'empagliflozin 5 MG'}, {'cui': 'C3265893', 'cui_str': 'Linagliptin 2.5 MG'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3883488', 'cui_str': 'empagliflozin 25 MG / Linagliptin 5 MG [Glyxambi]'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0607173,The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations.,"[{'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology and Department of Population and Data Sciences, UT Southwestern Medical Center , Dallas, TX, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Beetz', 'Affiliation': 'Global Clinical Operations, Early Trials, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riß, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Sennewald', 'Affiliation': 'Global Clinical Operations, Early Trials, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riß, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Schuler-Metz', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riß, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bertulis', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riß, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Loley', 'Affiliation': 'Biostatistics and Data Sciences, Clinical Statistics, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riß, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lang', 'Affiliation': 'Biostatistics and Data Sciences, Clinical Statistics, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riß, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lippert', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riß, Germany.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Clinical Development & Cardiometabolism and Respiratory Medicine, Boehringer Ingelheim International GmbH , Ingelheim, Germany.'}, {'ForeName': 'Linda Shapiro', 'Initials': 'LS', 'LastName': 'Manning', 'Affiliation': 'Clinical Development & Medical Affairs - Cardiometabolism, Boehringer Ingelheim Pharmaceuticals Inc , Ridgefield, CT, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Terada', 'Affiliation': 'Clinical Development & Medical Affairs - Cardiometabolism, Boehringer Ingelheim Pharmaceuticals Inc , Ridgefield, CT, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1750228']
55,32359674,Pilot trial investigating a brief behavioral economic intervention as an adjunctive treatment for alcohol use disorder.,"OBJECTIVE


Behavioral economic research suggests that increasing the salience of a delayed reward may improve capacity for delaying gratification and increase behavior allocated toward obtaining larger, delayed substance-free reward rather than smaller, more immediate reward such as alcohol use. This study aimed to improve the efficacy of outpatient alcohol use disorder (AUD) treatment by adding elements that target behavioral economic mechanisms of change.
METHOD


Forty-one (N = 41) adults in outpatient AUD treatment were recruited and 37 participants were retained at follow-up. Following baseline assessment, participants received either the Substance Free Activity Session (SFAS), a single-session behavioral economic-informed intervention focused on increasing future orientation and engagement in values-based substance-free activities or a health education control intervention. Participants in both conditions received weekly prompts (via text or email) relevant to their respective intervention for four weeks. Participants (68.3% male; 70.7% Caucasian, M age = 38.24, SD = 12.69) reported an average of 3.95 (SD = 4.72) binge drinking episodes (4/5 drinks per occasion for a woman/man) and 5.05 (SD = 5.32) drinks per drinking day 30-days prior to treatment entry.
RESULTS


The study provided initial support for the feasibility and acceptability of implementing the SFAS within a treatment setting. Participants reported high levels of satisfaction with the SFAS (M = 9.08 (SD = 0.94), on a scale of 1-10). At 3-month follow-up, the SFAS was associated with reductions in the proportion of activity participation and enjoyment (reinforcement) related to substance-use relative to substance-free activities and in alcohol demand compared to control.
CONCLUSION


These preliminary results provide initial support for targeting behavioral economic mechanisms of change in an outpatient AUD treatment with a single-session intervention plus remote delivery of booster prompts.",2020,"At 3-month follow-up, the SFAS was associated with reductions in the proportion of activity participation and enjoyment (reinforcement) related to substance-use relative to substance-free activities and in alcohol demand compared to control.
","['Forty-one', 'N\xa0=\xa041) adults in outpatient AUD treatment were recruited and 37 participants were retained at follow-up', 'Participants (68.3% male; 70.7% Caucasian, M age\xa0=\xa038.24, SD\xa0=\xa012.69) reported an average of 3.95 (SD\xa0=\xa04.72) binge drinking episodes (4/5 drinks per occasion for a woman/man) and 5.05 (SD\xa0=\xa05.32) drinks per drinking day']","['behavioral economic intervention', 'Substance Free Activity Session (SFAS), a single-session behavioral economic-informed intervention focused on increasing future orientation and engagement in values-based substance-free activities or a health education control intervention']",['proportion of activity participation and enjoyment (reinforcement'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]",41.0,0.0368838,"At 3-month follow-up, the SFAS was associated with reductions in the proportion of activity participation and enjoyment (reinforcement) related to substance-use relative to substance-free activities and in alcohol demand compared to control.
","[{'ForeName': 'Lidia Z', 'Initials': 'LZ', 'LastName': 'Meshesha', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, United States of America; Department of Psychology, The University of Memphis, Memphis, TN, United States of America. Electronic address: lidia_meshesha@brown.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Soltis', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, TN, United States of America.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Wise', 'Affiliation': 'Mental Health Resources, Memphis, TN, United States of America.'}, {'ForeName': 'Damaris J', 'Initials': 'DJ', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, United States of America.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, TN, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108002']
56,32369630,In situ decompression vs conservative treatment for mild ulnar neuropathy at the elbow.,"INTRODUCTION


The best treatment strategy for mild ulnar neuropathy at the elbow (UNE) is not known, due to lack of trials comparing surgery vs conservative treatment.
METHODS


We recruited patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis. Patients were randomly allocated to either in situ decompression or conservative treatment. The primary outcome was the proportion of patients with subjective symptom improvement at short-term (3 months) and long-term (6-12 months) follow-up.
RESULTS


One hundred seventeen patients were included: 56 and 61 patients were allocated to surgery and conservative treatment, respectively. A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% vs 50%; odds ratio, 5.6; P < .001), but no differences were observed at long-term follow-up.
DISCUSSION


In situ decompression for mild UNE may result in faster relief of symptoms when compared with conservative treatment, but at long-term follow-up no differences were observed.",2020,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","['Patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis were recruited', '117 patients were included: 56 and 61 patients']","['situ decompression or conservative treatment', 'situ decompression versus conservative treatment']","['relief of symptoms', 'proportion of patients with subjective symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.0474031,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","[{'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Pompe', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Tobien', 'Initials': 'T', 'LastName': 'Schreuder', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Laurien L', 'Initials': 'LL', 'LastName': 'Teunissen', 'Affiliation': 'Department of Neurology, St. Antonius Ziekenhuis Nieuwegein, The Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beekman', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26912']
57,32372407,Efficacy of a novel post-foaming dental gel on gingival inflammation: A randomized controlled clinical trial.,"BACKGROUND


A pilot randomized controlled clinical trial was performed to evaluate the efficacy of a post-foaming dental gel containing cetylpridinium chloride (CPC), hydrogen peroxide (H 2  O 2  ), sodium bicarbonate, and antioxidants on periodontal/oral health.
METHODS


Individuals with gingivitis or mild-moderate periodontitis (n=36) were included and randomly assigned to Group 1 and 2 with foaming gel loaded on a mouthpiece with a light source and controlled warming heat built-in unit or on a toothbrush, respectively, in addition to regular twice-daily brushing. Group 3 served as control with twice daily brushing and further assigned split-mouth to Group 3a-un-flossed and Group 3b-flossed. Gingival index (GI) and bleeding on probing (BOP) were evaluated in addition to plaque index (PI), pocket depth, and clinical attachment level at days 14, 28, 42 (treatment), and 60 (maintenance). Subgingival plaque microbial profiles and gingival crevicular fluid (GCF) cytokine levels were determined by DNA-DNA hybridization and multiplexing assays, respectively. Exploratory analyses included esthetic outcomes: changes in tooth color and levels of volatile sulfur compounds in breath. Statistical analyses were conducted using ANOVA with a post hoc analysis of Fisher's LSD.
RESULTS


Use of post-foaming gel in both test groups resulted in significant changes in GI and BOP at Day 42 compared to control and un-flossed control (P<0.05). Device-enhanced foaming gel significantly reduced the PI in Group 1 at Day 42 compared to control and un-flossed control (P=0.02; P=0.007, respectively). GCF IL-6 and TNF-α levels were significantly reduced in Group 2 compared to control (P IL-6  =0.01, P TNF-α  =0.02). Post-foaming gel resulted in greater reductions in periodontopathogens, whereas health-associated species remained stable. Despite cessation of adjunct treatments, Group 1 and 2 continued having reduced levels of GI, BOP, and PI at Day 60 (P<0.05).
CONCLUSIONS


The novel post-foaming dental gel improves oral health by reducing gingival inflammation at the local site in addition to better esthetic outcomes.",2020,"GCF IL-6 and TNF-α levels were significantly reduced in Group 2 compared to control (p IL-6  = 0.01, p TNF-α  = 0.02).",['Individuals with gingivitis or mild-moderate periodontitis (n = 36'],"['foaming gel loaded on a mouthpiece with a light source and controlled warming heat built-in unit or on a toothbrush, respectively, in addition to regular twice-daily brushing', 'post-foaming dental gel containing cetylpridinium chloride (CPC), hydrogen peroxide, sodium bicarbonate and antioxidants', 'novel post-foaming dental gel', 'control with twice daily brushing and further assigned split-mouth to Group 3a-un-flossed and Group 3b-flossed']","['Device-enhanced foaming gel significantly reduced the PI', 'gingival inflammation', 'GI and BOP', 'levels of GI, BOP and PI at Day-60', 'Subgingival plaque microbial profiles and gingival crevicular fluid (GCF) cytokine levels', 'GCF IL-6 and TNF-α levels', 'tooth color and levels of volatile sulfur compounds in breath', 'plaque index (PI), pocket depth and clinical attachment level', 'Gingival index (GI) and bleeding on probing (BOP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1272952', 'cui_str': 'Dental gel'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0441870', 'cui_str': 'Group 3A'}, {'cui': 'C0441871', 'cui_str': 'Group 3B'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0038776', 'cui_str': 'Sulfur compound'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",36.0,0.0523912,"GCF IL-6 and TNF-α levels were significantly reduced in Group 2 compared to control (p IL-6  = 0.01, p TNF-α  = 0.02).","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Levine', 'Affiliation': 'GLO Science, Inc., New York, New York, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Goncalves', 'Affiliation': 'GLO Science, Inc., New York, New York, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Nguyen', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Hasturk', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, USA.'}]",Journal of periodontology,['10.1002/JPER.19-0594']
58,32371116,Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial.,"BACKGROUND & AIMS


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


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


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


In a multicenter, randomized trial, we found that including CADe in real-time colonoscopy significantly increases ADR and adenomas detected per colonoscopy without increasing withdrawal time. ClinicalTrials.gov no: 04079478.",2020,"There was no significant difference between groups in withdrawal time (417±101 sec for the CADe group vs 435±149 for controls; P=.1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
","['685 subjects (61.32±10.2 years old; 337 women) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or work up due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at three centers in Italy from September through November 2019', 'polyps with high-accuracy']","['Real-Time Computer-Aided Detection', 'high-definition colonoscopies with the CADe system or without (controls', 'CADe system']","['adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma', 'ADR', 'resection of non-neoplastic lesions', 'withdrawal time', 'safety and efficacy', 'Adenomas detected per colonoscopy', 'adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]",,0.129523,"There was no significant difference between groups in withdrawal time (417±101 sec for the CADe group vs 435±149 for controls; P=.1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy. Electronic address: alessandro.repici@hunimed.eu.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Badalamenti', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maselli', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Correale', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rondonotti', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spadaccini', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Thanyan Alghanim Center for Gastroenterology and Hepatology, Alamiri Hospital, Kuwait, Kuwait.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fugazza', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderloni', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Piera Alessia', 'Initials': 'PA', 'LastName': 'Galtieri', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Pellegatta', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Carrara', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Di Leo', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Craviotto', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lamonaca', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorenzetti', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Andrealli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Kansas City Veterans Affairs Hospital, Kansas City, Missouri.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosch', 'Affiliation': 'Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}]",Gastroenterology,['10.1053/j.gastro.2020.04.062']
59,32374787,Anodal transcranial direct current stimulation reduces collinear lateral inhibition in normal peripheral vision.,"Collinear flanking stimuli can reduce the detectability of a Gabor target presented in peripheral vision. This phenomenon is called collinear lateral inhibition and it may contribute to crowding in peripheral vision. Perceptual learning can reduce collinear lateral inhibition in peripheral vision, however intensive training is required. Our aim was to assess whether modulation of collinear lateral inhibition can be achieved within a short time-frame using a single 20-minute session of primary visual cortex anodal transcranial direct current stimulation (a-tDCS). Thirteen observers with normal vision performed a 2AFC contrast detection task with collinear flankers positioned at a distance of 2λ from the target (lateral inhibition) or 6λ (control condition). The stimuli were presented 6° to the left of a central cross and fixation was monitored with an infra-red eye tracker. Participants each completed two randomly sequenced, single-masked stimulation sessions; real anodal tDCS and sham tDCS. For the 2λ separation condition, a-tDCS induced a significant reduction in detection threshold (reduced lateral inhibition). Sham stimulation had no effect. No effects of a-tDCS were observed for the 6λ separation condition. This result lays the foundation for future work investigating whether a-tDCS may be useful as a visual rehabilitation tool for individuals with central vision loss who are reliant on peripheral vision.",2020,"For the 2λ separation condition, a-tDCS induced a significant reduction in detection threshold (reduced lateral inhibition).","['individuals with central vision loss who are reliant on peripheral vision', 'normal peripheral vision']","['single-masked stimulation sessions; real anodal tDCS and sham tDCS', 'Perceptual learning', 'Anodal transcranial direct current stimulation']",['detection threshold (reduced lateral inhibition'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0152191', 'cui_str': 'Central scotoma'}, {'cui': 'C0234628', 'cui_str': 'Peripheral vision'}, {'cui': 'C0278208', 'cui_str': 'Normal peripheral vision'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",13.0,0.0643383,"For the 2λ separation condition, a-tDCS induced a significant reduction in detection threshold (reduced lateral inhibition).","[{'ForeName': 'Rajkumar Nallour', 'Initials': 'RN', 'LastName': 'Raveendran', 'Affiliation': 'Envision Research Institute, Wichita, Kansas, United States of America.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Tsang', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Dilraj', 'Initials': 'D', 'LastName': 'Tiwana', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chow', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'School of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0232276']
60,32376080,Resting State Functional Connectivity and Outcomes of Psychotherapies for Late-Life Depression.,"BACKGROUND


Problem solving therapy (PST) and ""Engage,"" a reward-exposure"" based therapy, are important treatment options for late-life depression, given modest efficacy of antidepressants in this disorder. Abnormal function of the reward and default mode networks has been observed during depressive episodes. This study examined whether resting state functional connectivity (rsFC) of reward and DMN circuitries is associated with treatment outcomes.
METHODS


Thirty-two older adults with major depression (mean age = 72.7) were randomized to 9-weeks of either PST or ""Engage."" We assessed rsFC at baseline and week 6. We placed seeds in three a priori regions of interest: subgenual anterior cingulate cortex (sgACC), dorsal anterior cingulate cortex (dACC), and nucleus accumbens (NAcc). Outcome measures included the Hamilton Depression Rating Scale (HAMD) and the Behavioral Activation for Depression Scale (BADS).
RESULTS


In both PST and ""Engage,"" higher rsFC between the sgACC and middle temporal gyrus at baseline was associated with greater improvement in depression severity (HAMD). Preliminary findings suggested that in ""Engage"" treated participants, lower rsFC between the dACC and dorsomedial prefrontal cortex at baseline was associated with HAMD improvement. Finally, in Engage only, increased rsFC from baseline to week 6 between NAcc and Superior Parietal Cortex was associated with increased BADS scores.
CONCLUSION


The results suggest that patients who present with higher rsFC between the sgACC and a structure within the DMN may benefit from behavioral psychotherapies for late life depression. ""Engage"" may lead to increased rsFC within the reward system reflecting a reconditioning of the reward systems by reward exposure.",2020,"In both PST and ""Engage,"" higher rsFC between the sgACC and middle temporal gyrus at baseline was associated with greater improvement in depression severity (HAMD).",['Thirty-two older adults with major depression (mean age\u202f=\u202f72.7'],"['Problem solving therapy (PST', 'PST or ""Engage']","['BADS scores', 'anterior cingulate cortex (sgACC), dorsal anterior cingulate cortex (dACC), and nucleus accumbens (NAcc', 'depression severity (HAMD', 'Hamilton Depression Rating Scale (HAMD) and the Behavioral Activation for Depression Scale (BADS']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",32.0,0.0436281,"In both PST and ""Engage,"" higher rsFC between the sgACC and middle temporal gyrus at baseline was associated with greater improvement in depression severity (HAMD).","[{'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY. Electronic address: nis2051@med.cornell.edu.'}, {'ForeName': 'Lindsay W', 'Initials': 'LW', 'LastName': 'Victoria', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Dunlop', 'Affiliation': 'Feil Family Brain Mind Research Institute, Weill Cornell Medicine (KD and CL), New York, NY.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Respino', 'Affiliation': 'Rush University Medical Center (MR), Chicago, IL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hoptman', 'Affiliation': 'The Nathan S. Kline Institute for Psychiatric Research (MJH), Orangeburg, NY; New York University School of Medicine (MJH), New York, NY.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'Columbia University (SZM), New York, NY; Haifa University (SZM), Haifa, Israel.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Oberlin', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Liston', 'Affiliation': 'Feil Family Brain Mind Research Institute, Weill Cornell Medicine (KD and CL), New York, NY.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Areán', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences (PAA), University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine (NS, LWV, LO, FMG, and GSA), White Plains, NY.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.04.008']
61,32300012,"Social, psychological, and demographic characteristics of dehumanization toward immigrants.","This study extends the current body of work on dehumanization by evaluating the social, psychological, and demographic correlates of blatant disregard for immigrants. Participants ( n  = 468) were randomly assigned to read a scenario where 1) an immigrant or 2) an immigrant and their child were caught illegally crossing the southern border of the United States, and then rated how long they should spend in jail if convicted. Participants reported that they would sentence the immigrant to more jail time than the immigrant and child. Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers). Crucially, endorsed social harms accounted for explained variance beyond simply holding conservative views. We position these data within the current literature on dehumanization theory and immigration issues.",2020,"Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers).","['Participants ( n  = 468', 'immigrants']",[],['jail time'],"[{'cui': 'C0282163', 'cui_str': 'Immigrant'}]",[],"[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",468.0,0.0240809,"Those who sent immigrants to jail for more time also viewed them as socially distant and less human, described immigration in impersonal terms, and endorsed other social harms unrelated to immigration (e.g., the death penalty for convicted murderers).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Markowitz', 'Affiliation': 'School of Journalism and Communication, University of Oregon, Eugene, OR 97403.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Slovic', 'Affiliation': 'Decision Research, Eugene, OR 97401; pslovic@uoregon.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1921790117']
62,32374527,A Secondary Data Analysis Examining Young Adults' Performance in an Internet Weight Loss Program with Financial Incentives.,"OBJECTIVE


In traditional behavioral weight loss (BWL) programs, young adults fare worse than older adults with respect to engagement, retention, and weight loss, but money and use of technology have been cited as program factors that might improve outcomes for this population. This study evaluated young adult performance in internet-based BWL (IBWL) offering financial incentives for self-monitoring and weight loss.
METHODS


Participants (N = 180; BMI = 33.2 ± 6.0 kg/m 2  ) were randomly assigned to a 12-week IBWL or IBWL + incentives (IBWL + $) group. This secondary data analysis compared young adults (ages 18-35) in IBWL (n = 16) with young adults in IBWL + $ (n = 12) on percent weight loss, engagement, and retention. Young adults (n = 28) were also compared with older adults (ages 36-70; n = 152) on these outcomes.
RESULTS


Young adult weight loss was -2.8% ± 5.2% in IBWL and -5.4% ± 5.7% in IBWL + $ (P = 0.23, partial η 2   = 0.06). A greater proportion of young adults in IBWL + $ achieved a 10% weight loss compared with IBWL (42% vs. 6%, P = 0.02). Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
CONCLUSIONS


Findings suggest that technology-based BWL has the potential to eliminate weight loss disparities observed between young adults and older adults in in-person BWL trials. Moreover, adding financial incentives holds promise for promoting clinically meaningful weight loss for young adults.",2020,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","['young adults', 'Participants (N\u2009=\u2009180; BMI\u2009=\u200933.2\u2009±\u20096.0 kg/m 2  ', 'young adults and older adults', 'young adults fare worse than older adults', 'Young adults (n\u2009=\u200928) were also compared with older adults (ages 36-70; n\u2009=\u2009152) on these outcomes', 'young adults (ages 18-35) in IBWL (n\u2009=\u200916) with young adults in IBWL\u2009+\u2009$ (n\u2009=\u200912) on percent weight loss, engagement, and retention']","['technology-based BWL', 'IBWL or IBWL\u2009+\u2009incentives (IBWL\u2009+\u2009$) group', 'traditional behavioral weight loss (BWL) programs']","['weight loss', 'retention or weight loss']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0386472,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Services, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reading', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, Miriam Hospital, Providence, Rhode Island, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22797']
63,32375440,[Efficacy and prognosis of phentolamine in the treatment of patients with myocardial injury due to sepsis].,"Objective:  To explore the effect of phenolamine on the outcome and prognosis of patients with myocardial injury due to sepsis.  Methods:  From January 2015 to December 2017, 62 septic patients with myocardial injury were randomly divided into study group ( n= 32) and control group ( n= 30). Two groups were given conventional treatment, while the study group was treated with phentolamine. The NT-pro brain natriuretic pepitide (NT-proBNP), cardiac troponin I (cTnI), lactate dehydrogenase (LDH), creatine kinase isoenzymes (CK-MB) and tumor necrosis factor (TNF)-α, high-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-1β, IL-6 were detected at 0,12, 24, 48, 72 h and 7 d after hospitalization. And left ventricular ejection fraction (LVEF), e', E and A in each time period were observed. The 28 d survival rate and length of ICU stay were observed in both groups. The data were compared with single sample  t  test between the two groups.  Results:  After 12, 24, 48, 72 h and 7 d, NT-proBNP, cTnI, LDH, CK-MB, TNF-α, hs-CRP, IL-1β, IL-6 in the study group were all significantly lower than those in the control group (all  P< 0.05). The cardiac function indexes of LVEF, E/A and E/e' in the study group were all significantly improved when compared with those in the control group (all  P< 0.05). The length of ICU stay and 28-day mortality in the study group were significantly lower than those in the control group ((9.8±3.6) d vs (13.0±4.1) d,  t= 3.152,  P= 0.004; 21.9% vs 36.7%, χ(2)=5.078,  P= 0.021).  Conclusion:  Combined application of phentolamine can significantly improve the outcome of sepsis patients with myocardial injury and improve the survival rate.",2020,"The length of ICU stay and 28-day mortality in the study group were significantly lower than those in the control group ((9.8±3.6) d vs (13.0±4.1) d,  t= 3.152,  P= 0.004; 21.9% vs 36.7%, χ(2)=5.078,  P= 0.021).  ","['patients with myocardial injury due to sepsis', 'From January 2015 to December 2017, 62 septic patients with myocardial injury']","['phenolamine', 'phentolamine']","['I (cTnI), lactate dehydrogenase (LDH), creatine kinase isoenzymes (CK-MB) and tumor necrosis factor (TNF)-α, high-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-1β, IL-6', 'survival rate and length of ICU stay', ""And left ventricular ejection fraction (LVEF), e', E and A in each time period"", 'cardiac function indexes of LVEF, E/A and E/e', 'length of ICU stay and 28-day mortality', 'NT-proBNP, cTnI, LDH, CK-MB, TNF-α, hs-CRP, IL-1β, IL-6', 'survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]","[{'cui': 'C0031448', 'cui_str': 'Phentolamine'}]","[{'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0010288', 'cui_str': 'Creatine kinase isoenzyme'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",62.0,0.0286791,"The length of ICU stay and 28-day mortality in the study group were significantly lower than those in the control group ((9.8±3.6) d vs (13.0±4.1) d,  t= 3.152,  P= 0.004; 21.9% vs 36.7%, χ(2)=5.078,  P= 0.021).  ","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Emergency, Wuming Hospital of Guangxi Medical University, Nanning 530199, China.'}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Li', 'Affiliation': 'Intensive Care Unit of Neorology, Affiliated Hospital of Youjiang Medical University for Nationalities, Baise 533000, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Mo', 'Affiliation': 'Intensive Care Unit, Nanning Red Cross Hospital, Nanning 530012, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20190912-02022']
64,32372750,Assessment of the Feasibility and Acceptability of Using Water Pasteurization Indicators to Increase Access to Safe Drinking Water in the Peruvian Amazon.,"Approximately two billion people lack access to microbiologically safe drinking water globally. Boiling is the most popular household water treatment method and significantly reduces diarrheal disease, but is often practiced inconsistently or ineffectively. The use of low-cost technologies to improve boiling is one approach with potential for increasing access to safe drinking water. We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015. A total of 28 randomly selected households were enrolled from a rural and a peri-urban community. All households trialed two WAPI designs, each for a 2-week period. Ninety-six percent of participants demonstrated the correct use of the WAPIs at the end of each trial, and 88% expressed satisfaction with both WAPI models. Ease of use, short treatment time, knowledge of the association between WAPI use and improved health, and the taste of treated water were among the key factors that influenced acceptability. Ease of use was the key factor that influenced design preference. Participants in both communities preferred a WAPI with a plastic box that floated on the water's surface compared with a WAPI with a wire that was dipped into the pot of drinking water while it was heating (77% versus 15%,  P  < 0.001); we selected the box design for a subsequent randomized trial of this intervention. The high feasibility and acceptability of the WAPIs in this study suggest that these interventions have potential to increase access to safe water in resource-limited settings.",2020,We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015.,"['Peruvian Amazon in 2015', '28 randomly selected households were enrolled from a rural and a peri-urban community']",['water pasteurization indicators (WAPIs'],['diarrheal disease'],"[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0597885', 'cui_str': 'Pasteurization'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]","[{'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}]",28.0,0.026785,We conducted household trials to evaluate the feasibility and acceptability of water pasteurization indicators (WAPIs) in the Peruvian Amazon in 2015.,"[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Heitzinger', 'Affiliation': 'Innovacion Por la Salud Y el Desarollo (IPSYD), Asociación Benéfica Prisma, Lima, Peru.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Hawes', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Claudio A', 'Initials': 'CA', 'LastName': 'Rocha', 'Affiliation': 'U.S. Naval Medical Research Unit No. 6, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Regional Center for Disease Prevention and Control, Loreto Regional Ministry of Health, Iquitos, Peru.'}, {'ForeName': 'Carlton A', 'Initials': 'CA', 'LastName': 'Evans', 'Affiliation': 'IFHAD: Innovation for Health and Development, Laboratory of Research and Development, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.18-0963']
65,32369480,Effect of short-term prednisone on beta-cell function in subjects with type 2 diabetes mellitus and healthy subjects.,"OBJECTIVE


For those with type 2 diabetes mellitus (T2DM), impact of short-term high-dose glucocorticoid exposure on beta-cell function is unknown. This study aims to compare the impact on beta-cell function and insulin resistance of prednisone 40 mg between adults with newly diagnosed T2DM and healthy adults.
METHODS


Five adults with T2DM and five healthy adults, all between 18-50 years, were enrolled. T2DM diagnosis was less than one year prior, HbA1c<75 mmol/mol (9.0%), with metformin treatment only. Pre- and post-therapy testing included 75-g oral glucose tolerance, plasma glucose, C-peptide, and insulin. Intervention therapy was prednisone 40mg daily for 3 days.
RESULTS


Upon therapy completion, HOMA-IR did not increase or differ between groups. Percentile difference for HOMA-%B and insulinogenic index in those with T2DM was significantly lower statistically (50.4% and 69.2% respectively) compared to healthy subjects (19% and 32.2%).
CONCLUSIONS


Contrary to the assumption that insulin resistance is the main driver of glucocorticoid-induced hyperglycemia, results indicate that decreased beta-cell insulin secretion is the more likely cause in those with T2DM. This is evidenced by significant drops in C-peptide AUC and HOMA-%B and increased glucose AUC in T2DM group only. These results may be caused by increased beta-cell fragility along with reduced recovery ability after glucocorticoid exposure. ClinicalTrials.gov NCT03661684.",2020,This is evidenced by significant drops in C-peptide AUC and HOMA-%B and increased glucose AUC in T2DM group only.,"['Five adults with T2DM and five healthy adults, all between 18-50 years, were enrolled', 'subjects with type 2 diabetes mellitus and healthy subjects', 'adults with newly diagnosed T2DM and healthy adults']","['prednisone', 'short-term prednisone', 'metformin']","['HOMA-%B and insulinogenic index', 'T2DM diagnosis', 'beta-cell fragility', '75-g oral glucose tolerance, plasma glucose, C-peptide, and insulin', 'HOMA-IR', 'beta-cell function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",5.0,0.0451943,This is evidenced by significant drops in C-peptide AUC and HOMA-%B and increased glucose AUC in T2DM group only.,"[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'May M', 'Initials': 'MM', 'LastName': 'Adel', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Tahsin', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Guerra', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Fogelfeld', 'Affiliation': 'John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, United States of America.'}]",PloS one,['10.1371/journal.pone.0231190']
66,32372387,Comparing the Potential for Irritation of a Ceramide-Based Moisturizer with a Urea-Based Moisturizer for Pediatric Atopic Dermatitis.,"INTRODUCTION


Moisturizers are one of the mainstays of the topical treatment of atopic dermatitis (AD). One of the adverse effects of moisturizers is skin irritation, especially on excoriated AD skin. We compared the potential for irritation of two commercially available moisturizer products for the treatment of AD: a ceramide-based moisturizer (Ceradan ®  Cream; Hyphens Pharma Pte Ltd, Singapore) and a urea 5% moisturizer (Aqurea Lite Cream; ICA Pharma Pte Ltd, Singapore).
METHODS


We performed a prospective single-blind randomized controlled study recruiting AD patients aged between 8 and 16 years with symmetrical or near symmetrical scratch marks (excoriations) of at least grade 2 to 3 severity score, according to the Eczema Area and Severity Index (EASI), over bilateral antecubital fossae. Subjects were randomized to receive the ceramide-based moisturizer to either the left or right antecubital fossa or urea 5% cream to the other antecubital fossa. Subjects were asked to grade the immediate skin irritation of both creams on a standard visual analogue scale (VAS) and which cream they would prefer to use as a daily moisturizer. Primary outcome was the mean irritant score of each cream, and secondary outcome was the subjects' preference of either cream as their daily moisturizer.
RESULTS


A total of 42 participants were enrolled with a mean age of 11 years 5 months. The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035). More participants also preferred the ceramide-based cream over urea 5% cream (62% versus 38%) as their daily moisturizer, but this did not reach statistical significance (p = 0.164).
CONCLUSIONS


A ceramide-based moisturizer may be considered as a suitable choice for children to minimize irritation from moisturizer treatment for AD.",2020,"The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035).","['Pediatric Atopic Dermatitis', 'AD patients aged between 8 and 16\xa0years with symmetrical or near symmetrical scratch marks (excoriations) of at least grade 2 to 3 severity score, according to the Eczema Area and Severity Index (EASI), over bilateral antecubital fossae', '42 participants were enrolled with a mean age of 11\xa0years 5\xa0months']","['ceramide-based moisturizer to either the left or right antecubital fossa or urea 5% cream to the other antecubital fossa', 'Ceramide-Based Moisturizer with a Urea-Based Moisturizer']","['standard visual analogue scale (VAS', 'mean irritant score of each cream', ""subjects' preference of either cream as their daily moisturizer"", 'mean VAS score']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0446523', 'cui_str': 'Antecubital fossa (surface region)'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",42.0,0.0323502,"The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035).","[{'ForeName': 'Valerie Pui Yoong', 'Initials': 'VPY', 'LastName': 'Ho', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore. valerie.ho.p.y@singhealth.com.sg.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ma', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Hui Min', 'Initials': 'HM', 'LastName': 'Liew', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Michelle Si Ying', 'Initials': 'MSY', 'LastName': 'Ng', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Mark Jean Aan', 'Initials': 'MJA', 'LastName': 'Koh', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}]",Dermatology and therapy,['10.1007/s13555-020-00388-6']
67,32379396,Does the length of uniportal video-assisted thoracoscopic lobectomy affect postoperative pain? Results of a randomized controlled trial.,"BACKGROUND


Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has become a common approach for the treatment of early stage lung cancer. Here, we aimed to establish whether the length of uniportal incision could affect postoperative pain and surgical outcomes in consecutive patients undergoing uniportal VATS lobectomy for early stage lung cancer.
METHODS


This was a unicenter Randomized Control Trial (NCT03218098). Consecutive patients undergoing uniportal VATS lobectomy for Stage I lung cancer were randomly assigned to a Small Incision group or Long Incision group in 1:1 ratio based on whether patients received a 4 cm or 8 cm incision. The endpoints were to compare the intergroup difference regarding (i) postoperative pain measured by brief pain inventory (BPI) questionnaire (first endpoint); (ii) operative time; (iii) length of chest drainage; (iv) length of hospital stay; (v) postoperative complications; and (vi) pulmonary functional status (secondary endpoints).
RESULTS


A total of 48 patients were eligible for the study. Four patients were excluded; the study population included 44 patients: 23 within the Small Incision group, and 21 within the Long Incision group. The 11 BPI scores between the two groups showed no significant difference. Small Incision group presented higher operative time than Long Incision group (138.69 vs. 112.14 minutes; P = 0.0001) while no significant differences were found regarding length of hospital stay (P = 0.95); respiratory complications (P = 0.92); FEV1% (P = 0.63), and 6-Minute Walking Test (P = 0.77).
CONCLUSIONS


A larger incision for uniportal VATS lobectomy significantly reduced the operative time due to better exposure of the anatomical structures without increasing postoperative pain or affecting the surgical outcome.
KEY POINTS


A larger incision for uniportal VATS lobectomy significantly reduced the operative time due to better exposure of the anatomical structures without increasing postoperative pain or affecting the surgical outcome. To perform a larger incision could be a valuable strategy, particularly in nonexpert hands or when the patient's anatomy or tumor size make exposure of anatomic structures through smaller incisions difficult.",2020,"Small Incision group presented higher operative time than Long Incision group (138.69 vs. 112.14 minutes; P = 0.0001) while no significant differences were found regarding length of hospital stay (P = 0.95); respiratory complications (P = 0.92); FEV1% (P = 0.63), and 6-Minute Walking Test (P = 0.77).
","['48 patients were eligible for the study', 'consecutive patients undergoing uniportal VATS lobectomy for early stage lung cancer', 'I lung cancer', 'early stage lung cancer', 'Consecutive patients undergoing uniportal VATS lobectomy for Stage', 'Four patients were excluded; the study population included 44 patients: 23 within the Small Incision group, and 21 within the Long Incision group']","['Small Incision group or Long Incision group in 1:1 ratio based on whether patients received a 4 cm or 8 cm incision', 'uniportal video-assisted thoracoscopic lobectomy', 'uniportal incision', 'Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy']","['postoperative pain and surgical outcomes', 'respiratory complications', 'intergroup difference regarding (i) postoperative pain measured by brief pain inventory (BPI) questionnaire (first endpoint); (ii) operative time; (iii) length of chest drainage; (iv) length of hospital stay; (v) postoperative complications; and (vi) pulmonary functional status (secondary endpoints', '6-Minute Walking Test', 'length of hospital stay', 'operative time', '11 BPI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2732532', 'cui_str': 'Brief pain inventory score'}]",4.0,0.151599,"Small Incision group presented higher operative time than Long Incision group (138.69 vs. 112.14 minutes; P = 0.0001) while no significant differences were found regarding length of hospital stay (P = 0.95); respiratory complications (P = 0.92); FEV1% (P = 0.63), and 6-Minute Walking Test (P = 0.77).
","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Menna', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Poggi', 'Affiliation': 'Division of Thoracic Surgery, Policlinico Umberto I, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Andreetti', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Maurizi', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Ciccone', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': ""D'Andrilli"", 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Vanni', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Anna Rita', 'Initials': 'AR', 'LastName': 'Vestri', 'Affiliation': 'Department of Public Health and Infectious Disease, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fiorelli', 'Affiliation': 'Thoracic surgery Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santini', 'Affiliation': 'Thoracic surgery Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Venuta', 'Affiliation': 'Division of Thoracic Surgery, Policlinico Umberto I, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Erino Angelo', 'Initials': 'EA', 'LastName': 'Rendina', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}]",Thoracic cancer,['10.1111/1759-7714.13291']
68,32374724,The impact of an integrated depression and HIV treatment program on mental health and HIV care outcomes among people newly initiating antiretroviral therapy in Malawi.,"BACKGROUND


Depression is highly prevalent among patients newly starting antiretroviral treatment (ART) in Malawi and many other countries. Untreated depression at ART initiation can disrupt the HIV care continuum. Effective approaches for depression screening and treatment exist for low-resource settings, but they are rarely applied. Identifying effective implementation strategies are critical.
METHODS


A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a screening-only ""control"" phase and an active ""intervention"" phase. During the intervention phase, providers prescribed antidepressants or referred patients for Friendship Bench problem-solving therapy. We evaluated the program's impact on retention in HIV care, viral suppression, and depression remission at 6 months using tabular comparisons and log-binomial models to estimate adjusted risk ratios and mean differences among the intervention group relative to the control group.
RESULTS


Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms. During the intervention phase, 86% of participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants with moderate to severe depressive symptoms started antidepressants. Few participants in the intervention group received consistent depression treatment over their first 6 months in care. In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)].
CONCLUSIONS


While it is feasible to integrate depression screening and treatment initiation into ART initiation, providing ongoing depression treatment over time is challenging. Similar implementation science studies focused on maintaining depression management will be increasingly important as we strive to understand and test the best ways to implement evidence-based depression treatment within HIV care.",2020,"In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)].
","['A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a', 'Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms', 'patients newly starting antiretroviral treatment (ART) in Malawi and many other countries', 'people newly initiating antiretroviral therapy in Malawi', 'participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants with moderate to severe depressive symptoms started antidepressants']","['Friendship Bench problem-solving therapy', 'consistent depression treatment', 'screening-only ""control"" phase and an active ""intervention"" phase', 'integrated depression and HIV treatment program']","['mental health and HIV care outcomes', 'HIV or mental health outcomes', 'retention in HIV care, viral suppression, and depression remission']","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0805605,"In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)].
","[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Stockton', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Udedi', 'Affiliation': 'NCDs & Mental Health Unit, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Kazione', 'Initials': 'K', 'LastName': 'Kulisewa', 'Affiliation': 'Department of Mental Health, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Tidziwe Centre, Lilongwe, Malawi.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Gaynes', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Mphonda', 'Affiliation': 'University of North Carolina Project-Malawi, Tidziwe Centre, Lilongwe, Malawi.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Maselko', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Pettifor', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Verhey', 'Affiliation': 'Friendship Bench Zimbabwe, Milton Park, Harare, Zimbabwe.'}, {'ForeName': 'Dixon', 'Initials': 'D', 'LastName': 'Chibanda', 'Affiliation': 'Friendship Bench Zimbabwe, Milton Park, Harare, Zimbabwe.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Lapidos-Salaiz', 'Affiliation': 'United States Agency for International Development (USAID), Arlington, VA, United States of America.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Pence', 'Affiliation': 'Epidemiology Department, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0231872']
69,32376293,Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study.,"BACKGROUND


Intermittent manual correction of the endotracheal tube cuff pressure (P cuff ) may delay the detection of underinflation (source of contaminated oropharyngeal content microaspiration) or overinflation (exposing to airway damage). Devices for automated continuous correction of P cuff  are appealing but some are inconvenient, expensive or even harmful. This prospective randomised controlled study tested whether the tracoe Smart Cuff Manager™ reduced the rate of patients undergoing≥1 episode of underinflation (P cuff <20 cmH 2 O), as compared with routine manual P cuff  correction. The rate of patients with≥1 overinflation episode (P cuff >30 cmH 2 O) and the incidence of under/overinflation were also compared.
METHODS


Patients with acute brain injury and likely to receive invasive mechanical ventilation for>48h were randomly allocated to receive, during 48h, automated P cuff  correction (combined with manual correction) or manual correction alone. P cuff  was measured with a dedicated manual manometer, at least every 8h.
RESULTS


Sixty patients were included and randomised (32 patients with manual and 28 with automated P cuff  correction) for 506 measurements of P cuff  (269 and 237, respectively). Automated correction of P cuff  was associated with a lower rate of patients with≥1 episode of underinflation (63% and 18%, respectively, P<0.001), a lower incidence of underinflation episodes (15% vs. 2%; P<0.001), a lower rate of manual corrections (77% vs. 58%; P<0.001). For overinflation, there were no significant between-groups differences (2% vs. 2%). The incidence of early respiratory infections was similar in both groups (29% vs. 25%, P=0.78).
CONCLUSIONS


The adjunction of continuous P cuff  control with the Tracoe Smart Cuff Manager™ to routine manual intermittent correction reduced the incidence of P cuff  underinflation episodes without provoking overinflation.
TRIAL REGISTRATION


ClinicalTrials NCT03330379. Registered 6 November 2017, https://clinicaltrials.gov/ct2/show/NCT03330379.",2020,"The incidence of early respiratory infections was similar in both groups (29% vs. 25%, p = 0.78).
","['Sixty patients were included and randomised (32 patients with manual and 28 with automated Pcuff correction) for 506 measurements of Pcuff (269 and 237, respectively', 'patients undergoing ≥ 1 episode of underinflation (Pcuff<20 cmH2O', 'Patients with acute brain injury and likely to receive invasive mechanical ventilation for > 48 h']","['automated Pcuff correction (combined with manual correction) or manual correction alone', 'endotracheal tube cuff pressure (Pcuff', 'Tracoe Smart Cuff ManagerTM', 'endotracheal tube cuff pressure with a portable elastomeric device']","['lower rate of manual corrections', 'Pcuff', 'incidence of early respiratory infections', 'underinflation episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",60.0,0.0808773,"The incidence of early respiratory infections was similar in both groups (29% vs. 25%, p = 0.78).
","[{'ForeName': 'Jérôme E', 'Initials': 'JE', 'LastName': 'Dauvergne', 'Affiliation': ""Service d'anesthésie-réanimation, hôpital Laënnec, centre hospitalier universitaire de Nantes, boulevard Jacques-Monod, Saint-Herblain, 44093 Nantes cedex 1, France. Electronic address: jerome.dauvergne@chu-nantes.fr.""}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Geffray', 'Affiliation': ""Service d'anesthésie-réanimation, Hôtel-Dieu, centre hospitalier universitaire, 44093, Nantes, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ""Service d'anesthésie-réanimation, Hôtel-Dieu, centre hospitalier universitaire, 44093, Nantes, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Rozec', 'Affiliation': ""Service d'anesthésie-réanimation, hôpital Laënnec, centre hospitalier universitaire de Nantes, boulevard Jacques-Monod, Saint-Herblain, 44093 Nantes cedex 1, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Lakhal', 'Affiliation': ""Service d'anesthésie-réanimation, hôpital Laënnec, centre hospitalier universitaire de Nantes, boulevard Jacques-Monod, Saint-Herblain, 44093 Nantes cedex 1, France. Electronic address: lakhal_karim@yahoo.fr.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.04.007']
70,32319040,Pharmacokinetics and Safety of Posaconazole Tablet Formulation in Chinese Participants at High Risk for Invasive Fungal Infection.,"INTRODUCTION


This study characterized the multidose pharmacokinetic (PK) characteristics of posaconazole tablets used as prophylactic antifungal therapy in Chinese patients with acute myelogenous leukemia (AML) at risk for invasive fungal infection (IFI).
METHODS


Participants in this open-label, single-arm, phase 1b study received posaconazole 300 mg twice daily on day 1 and then once daily for up to 28 days. In the intensive PK sampling subgroup, posaconazole was administered under fasting conditions on days 1 and 8, and blood samples were regularly collected over 24 h. Trough PK sampling was conducted in all participants on days 1, 2, 3, 8, 14, 21, and 28 without regard for food intake. Population PK characteristics were predicted using PK modeling. Primary endpoints were steady-state average concentration (C avg ) and percentage of participants with steady-state C avg  (predicted and observed) > 500 ng/ml. Treatment safety and efficacy were secondary endpoints.
RESULTS


Sixty-five adult Chinese participants were enrolled. On day 8, steady-state arithmetic mean C avg  was 1610 ng/ml (% coefficient of variation [%CV] 42.8%) in the intensive PK subgroup (n = 20). All participants achieved a steady-state C avg  > 500 ng/ml. Predicted C avg  (pC avg ) was 1770 ng/ml (%CV 33.7%) in the total population (n = 64); 92.2% of participants had pC avg  values ≥ 500 ng/ml (n = 59). The posaconazole tablet safety profile was consistent with that of the oral formulation, and the IFI rate was 3%.
CONCLUSION


In Chinese AML patients, the posaconazole 300-mg tablet provided PK data comparable with those of previous studies and was generally well tolerated and efficacious.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02387983.",2020,"The posaconazole tablet safety profile was consistent with that of the oral formulation, and the IFI rate was 3%.
","['Participants in this open-label, single-arm, phase 1b study received', 'Sixty-five adult Chinese participants were enrolled', 'Chinese Participants at High Risk for Invasive Fungal Infection', 'All participants achieved a steady-state C avg \u2009', 'Chinese patients with acute myelogenous leukemia (AML) at risk for invasive fungal infection (IFI']","['Posaconazole Tablet Formulation', 'posaconazole', 'posaconazole tablets']","['IFI rate', 'tolerated and efficacious', 'steady-state average concentration (C avg ) and percentage of participants with steady-state C avg  (predicted and observed)\u2009']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0936148', 'cui_str': 'posaconazole'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",65.0,0.271973,"The posaconazole tablet safety profile was consistent with that of the oral formulation, and the IFI rate was 3%.
","[{'ForeName': 'Kaiyan', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Peking University People's Hospital, Beijing, China. liukaiyan@medmail.com.cn.""}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Shanghai Ruijin Hospital, Beijing, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""The 307th Hospital of Chinese People's Liberation Army, Beijing, China.""}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Ning', 'Affiliation': ""The 307th Hospital of Chinese People's Liberation Army, Beijing, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': 'The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Shanghai Ruijin Hospital, Beijing, China.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Mangin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Winchell', 'Affiliation': 'Certara USA, Inc., Princeton, NJ, USA.'}, {'ForeName': 'Hetty', 'Initials': 'H', 'LastName': 'Waskin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Xu Min', 'Initials': 'XM', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01341-x']
71,32379763,Cost-Effectiveness of ramucirumab plus paclitaxel as a second-line therapy for advanced gastric or gastro-oesophageal cancer in China.,"AIM


That clinical trial (RAINBOW) showed that a 7.4 months overall survival benefit with the combination therapy with ramucirumab (RAM) and paclitaxel (PAC) as second-line therapy for patients with recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma, compared with placebo (PLA) plus paclitaxel. We performed an analysis to assess the cost-effectiveness of RAM from a Chinese perspective and recognized the range of drug costs.
METHODS


By building a Markov model to estimate quality-adjusted life-years (QALYs), life-years (LYs) and lifetime costs. Transition probabilities, costs and utilities were estimated for the published literature, Chinese health care system and local price setting. We performed threshold analyses and probabilistic sensitivity analyses to evaluate the uncertainty of the model.
RESULTS


Compared with PLA strategy, RAM strategy provided an incremental survival benefit of 1.22 LYs and 0.64 QALYs. The probabilistic sensitivity analysis showed that when RAM costs less than $151 or $753 per 4 weeks, the incremental cost-effectiveness ratio (ICER) approximated the willingness-to-pay threshold (WTP), suggesting that there was 50% likelihood that the ICER for RAM + PAC would be less than $44528.4 per QALY or $48121 per QALY, respectively.
CONCLUSIONS


For patients with advanced gastric or gastro-oesophageal junction adenocarcinoma who fail first-line chemotherapy, our results are conducive to the multilateral drug price guidance negotiations of RAM in China.",2020,"Compared with PLA strategy, RAM strategy provided an incremental survival benefit of 1.22 LYs and 0.64 QALYs.","['advanced gastric or gastro-oesophageal cancer in China', 'patients with advanced gastric or gastro-oesophageal junction adenocarcinoma who fail first-line chemotherapy', 'patients with recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma']","['ramucirumab plus paclitaxel', 'placebo (PLA) plus paclitaxel', 'ramucirumab (RAM) and paclitaxel (PAC']","['Transition probabilities, costs and utilities', 'quality-adjusted life-years (QALYs), life-years (LYs) and lifetime costs', 'incremental survival benefit', 'overall survival benefit', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0632798,"Compared with PLA strategy, RAM strategy provided an incremental survival benefit of 1.22 LYs and 0.64 QALYs.","[{'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The Xiangya Nursing School, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liubao', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'The Second Xiangya Hospital, PET-CT Center, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'The Xiangya Nursing School, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jianhe', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",PloS one,['10.1371/journal.pone.0232240']
72,32379766,Nocebo hyperalgesia can be induced by classical conditioning without involvement of expectancy.,"Influential theoretical accounts take the position that classical conditioning can induce placebo effects through conscious expectancies. In the current study two different conditioning procedures (hidden and open) were used to separate expectancy from conditioning in order to reveal the role of expectancy in the formation of nocebo hyperalgesia. Eighty-seven healthy females were randomly assigned to three groups (hidden conditioning, open conditioning, and control). Participants were selected according to the Fear of Pain Questionnaire scores and assigned to two subgroups: high and low level of fear of pain (trait). They received electrocutaneous pain stimuli preceded by either an orange or blue color. During the conditioning phase, one color was paired with pain stimuli of moderate intensity (control stimuli) and the other color was paired with pain stimuli of high intensity (nocebo stimuli) in both hidden and open conditioning groups. Only participants in the open conditioning group were informed about this association, however just before the testing phase the expectancy of hyperalgesia induced in this way was withdrawn. In the control group, both colors were followed by control pain stimuli. During the testing phase all participants received a series of stimuli of the same intensity, regardless of the preceding color. Participants rated pain intensity, expectancy of pain intensity and fear (state). We found that nocebo hyperalgesia was induced by hidden rather than open conditioning. The hidden conditioning procedure did not produce conscious expectancies related to pain. Nocebo hyperalgesia was induced in participants with low and high fear of pain and there was no difference in the magnitude of the nocebo effect between both groups. Nocebo hyperalgesia was not predicted by the fear of upcoming painful stimuli.",2020,Nocebo hyperalgesia was induced in participants with low and high fear of pain and there was no difference in the magnitude of the nocebo effect between both groups.,['Eighty-seven healthy females'],['electrocutaneous pain stimuli preceded by either an orange or blue color'],"['Fear of Pain Questionnaire scores', 'pain intensity, expectancy of pain intensity and fear (state', 'nocebo hyperalgesia', 'Nocebo hyperalgesia', 'low level of fear of pain (trait']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}]","[{'cui': 'C0233702', 'cui_str': 'Algophobia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",87.0,0.0171263,Nocebo hyperalgesia was induced in participants with low and high fear of pain and there was no difference in the magnitude of the nocebo effect between both groups.,"[{'ForeName': 'Elżbieta A', 'Initials': 'EA', 'LastName': 'Bajcar', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Wacław M', 'Initials': 'WM', 'LastName': 'Adamczyk', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Wiercioch-Kuzianik', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Bąbel', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}]",PloS one,['10.1371/journal.pone.0232108']
73,32379777,Transplacental transfer of glyburide in women with gestational diabetes and neonatal hypoglycemia risk.,"BACKGROUND


In pregnant women with gestational diabetes, glyburide can be an alternative to insulin despite concerns about its transplacental transfer. However, transplacental transfer of glyburide is poorly quantified and the relationship between cord blood glyburide concentration and hypoglycemia has not been studied. Our objective was to quantify the transplacental transfer of glyburide at delivery and to study the association between the cord blood glyburide concentration and the risk of neonatal hypoglycemia in patients with gestational diabetes treated with glyburide.
METHODS AND FINDINGS


INDAO was a multicenter, noninferiority, randomized trial conducted between May 2012 and November 2016 in 914 women with singleton pregnancies and gestational diabetes. An ancillary study was conducted in the 87 patients of the Bicêtre University Hospital Center. The sample consisted of 46 patients with utilizable assays at delivery. The relationships between glyburide concentration and the time since the last intake of glyburide and between fetal glyburide concentration and neonatal hypoglycemia were modeled with linear or logistic regressions using fractional polynomials. There was placental transfer of glyburide at a fetal to maternal ratio of 62% (95% CI [50; 74]). Umbilical cord blood glyburide concentration decreased steeply after the last maternal glyburide intake. After 24 hours, the mean umbilical cord blood concentration was less than 5 ng/mL. Neonatal hypoglycemia risk was increased with an odds ratio of hypoglycemia equal to 3.70 [1.40-9.77] for each 10 ng/mL increase in the cord blood glyburide concentration. However, no newborns were admitted to the NICU because of clinical signs of hypoglycemia or for treatment of hypoglycemia.
CONCLUSION


Considering that neonatal glyburide exposure may be limited by stopping treatment a sufficient time before labor, there may still be a place for glyburide in the management of gestational diabetes.",2020,"After 24 hours, the mean umbilical cord blood concentration was less than 5 ng/mL. Neonatal hypoglycemia risk was increased with an odds ratio of hypoglycemia equal to 3.70 [1.40-9.77] for each 10 ng/mL increase in the cord blood glyburide concentration.","['46 patients with utilizable assays at delivery', 'May 2012 and November 2016 in 914 women with singleton pregnancies and gestational diabetes', '87 patients of the Bicêtre University Hospital Center', 'pregnant women with gestational diabetes', 'patients with gestational diabetes treated with glyburide', 'women with gestational diabetes and neonatal hypoglycemia risk']",['glyburide'],"['fetal glyburide concentration and neonatal hypoglycemia', 'neonatal hypoglycemia', 'Umbilical cord blood glyburide concentration', 'mean umbilical cord blood concentration', 'Neonatal hypoglycemia risk', 'Transplacental transfer', 'placental transfer of glyburide', 'cord blood glyburide concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}]","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}]",914.0,0.0735579,"After 24 hours, the mean umbilical cord blood concentration was less than 5 ng/mL. Neonatal hypoglycemia risk was increased with an odds ratio of hypoglycemia equal to 3.70 [1.40-9.77] for each 10 ng/mL increase in the cord blood glyburide concentration.","[{'ForeName': 'Hanane', 'Initials': 'H', 'LastName': 'Bouchghoul', 'Affiliation': 'Department of Gynecology-Obstetrics, Assistance Publique-Hôpitaux de Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Alvarez', 'Affiliation': 'Département de Pharmacologie-Toxicologie, Assistance Publique-Hôpitaux de Paris, Hôpital Raymond Poincaré, MasSpecLab, Plateforme de spectrométrie de masse, Inserm U-1173, UFR PIFO, Université Versailles Saint Quentin-en-Yvelines, Garches, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Verstuyft', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Service de Génétique moléculaire, Pharmacogénétique et Hormonologie, Inserm U 1178 équipe Dépression, CESP, Université Paris-Sud, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bouyer', 'Affiliation': 'Université Paris-Saclay, UVSQ, Inserm, CESP, Villejuif, France.'}, {'ForeName': 'Marie-Victoire', 'Initials': 'MV', 'LastName': 'Senat', 'Affiliation': 'Department of Gynecology-Obstetrics, Assistance Publique-Hôpitaux de Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France.'}]",PloS one,['10.1371/journal.pone.0232002']
74,32381496,A randomised trial of high-flow nasal cannula in infants with moderate bronchiolitis.,"BACKGROUND


The objective was to determine whether high-flow nasal cannula (HFNC), a promising respiratory support in infant bronchiolitis, could reduce the proportion of treatment failure requiring escalation of care.
METHODS


In this randomised controlled trial, we assigned infants aged <6 months who had moderate bronchiolitis to receive either HFNC at 3 L·kg -1 ·min -1  or standard oxygen therapy. Crossover was not allowed. The primary outcome was the proportion of patients in treatment failure requiring escalation of care (mostly noninvasive ventilation) within 7 days following randomisation. Secondary outcomes included rates of transfer to the paediatric intensive care unit (PICU), oxygen, number of artificial nutritional support-free days and adverse events.
RESULTS


The analyses included 268 patients among the 2621 infants assessed for inclusion during two consecutive seasons in 17 French paediatric emergency departments. The percentage of infants in treatment failure was 14% (19 out of 133) in the study group, compared to 20% (27 out of 135) in the control group (OR 0.66, 95% CI 0.35-1.26; p=0.21). HFNC did not reduce the risk of admission to PICU (21 (15%) out of 133 in the study group  versus  26 (19%) out of 135 in the control group) (OR 0.78, 95% CI 0.41-1.41; p=0.45). The main reason for treatment failure was the worsening of modified Wood clinical asthma score (m-WCAS). Short-term assessment of respiratory status showed a significant difference for m-WCAS and respiratory rate in favour of HFNC. Three pneumothoraces were reported in the study group.
CONCLUSIONS


In patients with moderate bronchiolitis, there was no evidence of lower rate of escalating respiratory support among those receiving HFNC therapy.",2020,Short-term assessment of respiratory status showed a significant difference for m-WCAS and respiratory rate in favor HFNC.,"['Infants with Moderate Bronchiolitis', '268 patients among the 2621 infants assessed for inclusion during 2 consecutive seasons in 17 French pediatric emergency departments', 'patients with moderate bronchiolitis', 'infants younger than 6\u2005months who had moderate bronchiolitis to receive either']","['HFNC at 3\u2005L·kg -1 ·min -1  or standard oxygen therapy', 'High-Flow Nasal Cannula', 'high flow nasal cannula (HFNC', 'HFNC']","['m-WCAS and respiratory rate', 'risk of admission in PICU', 'rates of transfer in PICU, oxygen and nutritional-support length of days and adverse events', 'percentage of infants in treatment failure', 'proportion of patient in treatment failure requiring escalation of care (mostly non-invasive ventilation']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",3.0,0.275419,Short-term assessment of respiratory status showed a significant difference for m-WCAS and respiratory rate in favor HFNC.,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Durand', 'Affiliation': 'Pediatric Emergency Dept, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, Kremlin-Bicêtre, France.'}, {'ForeName': 'Tamma', 'Initials': 'T', 'LastName': 'Guiddir', 'Affiliation': 'Pediatric Emergency Dept, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, Kremlin-Bicêtre, France.'}, {'ForeName': 'Christèle', 'Initials': 'C', 'LastName': 'Kyheng', 'Affiliation': 'Pediatric Emergency Dept, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, Kremlin-Bicêtre, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Blanc', 'Affiliation': 'Villeneuve-Saint Georges Intercommunal Hospital, Villeneuve-Saint Georges, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Vignaud', 'Affiliation': 'Meaux Hospital, Meaux, France.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Epaud', 'Affiliation': 'Créteil Intercommunal Hospital, Créteil, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dugelay', 'Affiliation': 'Créteil Intercommunal Hospital, Créteil, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Breant', 'Affiliation': 'Melun Hospital, Melun, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Badier', 'Affiliation': 'Poissy Hospital, Poissy, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Degas-Bussière', 'Affiliation': 'Sud-Francilien Hospital, Corbeil-Essonnes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Phan', 'Affiliation': 'Chartres Hospital, Chartres, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Soussan-Banini', 'Affiliation': 'Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris, Boulogne-Billancourt, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Lehnert', 'Affiliation': 'Montargis Hospital, Amilly, France.'}, {'ForeName': 'Célestin', 'Initials': 'C', 'LastName': 'Mbamba', 'Affiliation': 'Gien Hospital, Gien, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barrey', 'Affiliation': 'Bry sur Marne Hospital, Bry sur Marne, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Tahiri', 'Affiliation': 'Dourdan Hospital, Dourdan, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Decobert', 'Affiliation': 'Orsay Hospital, Orsay, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saunier-Pernaudet', 'Affiliation': 'Fontainebleau Hospital, Fontainebleau, France.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Craiu', 'Affiliation': 'Pediatric Emergency Dept, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, Kremlin-Bicêtre, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Taveira', 'Affiliation': 'Antoine Béclère University Hospital, Assistance Publique-Hôpitaux de Paris, Clamart, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gajdos', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01926-2019']
75,32311001,Information feedback in relative grading: Evidence from a field experiment.,"Previous studies have revealed the role of relative performance information feedback on providing agent incentives under a relative rewarding scheme through laboratory experiments. This study examines the impact of relative performance information feedback of students' performance on their examination score under the relative grading scheme in an actual educational environment. Conducting a randomized controlled trial in a compulsory subject at a Japanese university, we show that the relative performance information feedback has a significantly positive impact on the students' examination score on average, but that the average positive impact is derived by the improvement of low-performing students.",2020,This study examines the impact of relative performance information feedback of students' performance on their examination score under the relative grading scheme in an actual educational environment.,['compulsory subject at a Japanese university'],[],[],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],[],,0.0904988,This study examines the impact of relative performance information feedback of students' performance on their examination score under the relative grading scheme in an actual educational environment.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kajitani', 'Affiliation': 'Faculty of Economics, Kyoto Sangyo University, Kyoto-city, Kyoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Morimoto', 'Affiliation': 'School of Political Science and Economics, Meiji University, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Shiba', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Faculty of Economics, Seikei University, Musashino-city, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0231548']
76,32375104,Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial.,"BACKGROUND


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


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


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


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


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


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.","[{'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Duengen', 'Affiliation': 'Department of Internal Medicine, Cardiology, Charité-Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center, Durham, United States.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Orvin', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Admon', 'Affiliation': 'Hadassah Hebrew University Hospital Ein Kerem, Heart Institute, Jerusalem, Israel.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Kettner', 'Affiliation': 'Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Shimony', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Otto', 'Affiliation': 'Experimental Medicine Cardiovascular, Bayer AG, Wuppertal, Germany. Electronic address: christiane.otto@bayer.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Becka', 'Affiliation': 'Research and Clinical Sciences Statistics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Kanefendt', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andres Iniguez', 'Initials': 'AI', 'LastName': 'Romo', 'Affiliation': 'Hospital Alvaro Cunqueiro, Servicio de la Cardiologia, Vigo, Spain.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Hasin', 'Affiliation': 'Shaare Zedek Medical Center, Department of Cardiology, Jerusalem, Israel.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': 'Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Gonzalo Calvo', 'Initials': 'GC', 'LastName': 'Rojas', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Division of Cardiology, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.012']
77,32379474,"Effects of a snack enriched with carob and Undaria pinnatifida (wakame) on metabolic parameters in a double blind, randomized clinical trial in obese patients.","Introduction


Introduction: the composition of snack foods likely influences the overall effect that snacking has on metabolism and obesity. The objective of the current study was to assess the responses to two different snacks, one of them supplemented with wakame and carobs, on cardiovascular risk factors, satiety, and subsequent food intake in obese subjects with metabolic syndrome. Material and Methods: forty patients were randomized in a clinical trial (NCT03420989, clinicaltrial.gov) to group I (enriched snack, n = 16) or group II (control snack, n = 16). At baseline and after 8 weeks biochemical parameters, dietary intakes, and nutritional status were assessed. The subjects also rated their feelings of satiety/hunger with a test meal. Results: no differences were detected in anthropometric parameters between both snacks. Changes in other parameters were detected in patients with enriched snacks, with a significant decrease in LDL-cholesterol by 7.4 % (intervention snack, -8.9 ± 2.3 mg/dL vs control snack, -0.9 ± 3.3 mg/dL; p = 0.03), in total cholesterol by 5.8 % (intervention snack, -10.4 ± 2.9 mg/dL vs control snack, -1.4 ± 3.2 mg/dL; p = 0.02), and in resistin level by 15.9 % (intervention snack, -1.0 ± 0.2 mg/dL vs control snack, -0.1 ± 0.3 mg/dL: p = 0.03). After the test meal, satiety scores (after 20 min and 40 min) were higher than fasting levels in both groups. The same results were obtained with the 100-mm, 5-point visual satiety scale. Conclusion: our study indicates that a wakame- and carob-enriched snack induces a significant decrease in total cholesterol, LDL-cholesterol, and resistin levels when compared to a control snack, without effects on food consumption, other cardiovascular parameters, or anthropometric parameters.",2020,"After the test meal, satiety scores (after 20 min and 40 min) were higher than fasting levels in both groups.","['forty patients', 'obese subjects with metabolic syndrome', 'obese patients']",['snack enriched with carob and Undaria pinnatifida (wakame'],"['total cholesterol', '5-point visual satiety scale', 'anthropometric parameters', 'satiety scores', 'resistin level', 'total cholesterol, LDL-cholesterol, and resistin levels', 'food consumption, other cardiovascular parameters, or anthropometric parameters', 'LDL-cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0065146', 'cui_str': 'Carob'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",40.0,0.0949986,"After the test meal, satiety scores (after 20 min and 40 min) were higher than fasting levels in both groups.","[{'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Departamento de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rico Bargués', 'Affiliation': 'Instituto Tecnológico Agrario de Castilla y León. Subdirección de Investigación y Tecnología. Consejería de Agricultura y Ganadería.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Martín-Diana', 'Affiliation': 'Instituto Tecnológico Agrario de Castilla y León. Subdirección de Investigación y Tecnología. Consejería de Agricultura y Ganadería.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez Villaluenga', 'Affiliation': 'Department of Food Characterization, Quality and Safety. Instituto de Ciencia y Tecnología de Alimentos y Nutrición (ICTAN-CSIC).'}, {'ForeName': 'Jonatan', 'Initials': 'J', 'LastName': 'Miranda', 'Affiliation': 'Nutrition and Obesity Group. Department of Nutrition and Food Science. Universidad del País Vasco (UPV/EHU), & Centro de Investigación Lucio Lascaray.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'de Luis Román', 'Affiliation': 'Centro de Investigación de Endocrinología y Nutrición. Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid.'}]",Nutricion hospitalaria,['10.20960/nh.02906']
78,32379479,[Effects of moderate to vigorous intensity interval exercise program on fitness and fatness in 11-and 12-years-old schoolchildren].,"Introduction


Introduction: there is growing evidence of concern for values in terms of physical condition and body composition alarming that place school child at risk parameters in physical health. Numerous investigations relate physical activity with improvement in physical condition and body composition. Objective: to analyze the effects of a sub-maximal intensity interval exercise program on physical condition (upper body isometric strength in both hands, lower body explosive strength, velocity-agility and cardiorespiratory fitness) and body composition (body mass index, % of body fat, waist circumference and waist/height index), all of them related to health, in schoolchildren of 11 and 12 years. Methods: an intervention was developed in which an experimental group participated and another control group with 28 schoolchildren each. Happened over 8 weeks, with sessions of total 30 minutes before the start of the academic activity 3 days per week. Different intervallic games were made with motor, cognitive and coordination challenges; with a moderate-vigorous intensity (70 %-80 % of maximum heart rate). The registration in physical condition and body composition was made through the ALPHA Battery. Results: significant improvements in isometric strength with both hands and a reduction in waist circumference and waist/height index. Conclusions: the results show significant improvements in indicators of fitness and fatness, however, it requires a long-term intervention to know if the other improvements achieved in the analyzed indicators are significant over time.",2020,"RESULTS


significant improvements in isometric strength with both hands and a reduction in waist circumference and waist/height index.
","['schoolchildren of 11 and 12 years', '11-and 12-years-old schoolchildren', 'experimental group participated and another control group with 28 schoolchildren each']","['sub-maximal intensity interval exercise program', 'moderate to vigorous intensity interval exercise program']","['fitness and fatness', 'waist circumference and waist/height index', 'physical condition (upper body isometric strength in both hands, lower body explosive strength, velocity-agility and cardiorespiratory fitness) and body composition (body mass index, % of body fat, waist circumference and waist/height index', 'indicators of fitness and fatness', 'isometric strength']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0155486,"RESULTS


significant improvements in isometric strength with both hands and a reduction in waist circumference and waist/height index.
","[{'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Gelabert Carulla', 'Affiliation': 'Universitat de Les Illes Balears.'}, {'ForeName': 'Adrià', 'Initials': 'A', 'LastName': 'Muntaner-Mas', 'Affiliation': 'Universidad de Las Islas Baleares.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Palou Sampol', 'Affiliation': 'Grupo PROFITH. Universidad de Granada.'}]",Nutricion hospitalaria,['10.20960/nh.02894']
79,32375613,[Control of ventricular rate in permanent atrial fibrillation: cardio-protec-tion and tissue hemodynamics].,"Objective To evaluate myocardial injury and tissue hemodynamics in elderly patients with permanent atrial fibrillation (AF) based on the achieved range of ventricular contraction rate (VCR).Materials and Methods This prospective, randomized, blind study included 75 patients aged ≥60 with permanent AF. All patients were prescribed bisoprolol as a VCR-reducing therapy. Patients were randomized to two groups according to the permuted-block design based on the range of resting VCR goal: group 1, 60-79 bpm (n=38) and group 2, 80-100 bpm (n=37). All patients also received perindopril and apixaban. Troponin I concentration was measured using the high-sensitivity assay (hsTn); parameters of tissue hemodynamics, including the mean blood flow velocity (Vm) and pulsatility index (PI), were measured using high-frequency ultrasound doppler flowmetry; echocardiographic indexes of left heart remodeling were recorded at baseline and after 6 month of VCR monitoring.Results Mean age of patients was 74±7 years. Medians [25th percentile; 75th percentile] of baseline hsTn concentrations were 10.2 [5.25; 21.2] ng / l in group 1 and 10.3 [5.4; 20.4] ng / ml in group 2 (p=0.91). 89.5 % of patients in group 1 and 100 % of patients in group 2 achieved the VCR range goal. At 6 month, resting VCRs were 70±4 bpm in group 1 (n=34) and 88±5 bpm in group 2 (n=37) (p1, p2&lt;0.001). According to echocardiographic data significant progression of myocardial remodeling was not observed. Concentrations of hsTn significantly decreased in both groups but the decrease was more pronounced in group 1, to 8.0 [4.13; 17.23; p1&lt;0.001] ng / l vs. 9.2 [4.8, 17.5] ng / l in group 2 (р1, p2&lt;0.001). A weak direct correlation was found between the VCR decrease and hsTn concentration (rs=0.44; p=0.009 in group 1, and rs=0.41; p=0.01 in group 2); regression coefficient was 0.78 at 95 % confidence interval (CI), from 0.21 to 1.3 (p=0.009) in group 1, and 0.14 at 95 % CI, from 0.04 to 0.24 (p=0.007) in group 2. Vm values were increased to 2.93±0.10 (p&lt;0.001) and 3.21±0.09 cm / sec (p&lt;0.001) and PIs were decreased to 1.42±0.03 conv. units (p&lt;0.01) and to 1.34±0.02 conv. units (p&lt;0.001) in groups 1 and 2, respectively.Conclusion The treatment aimed at VCR control in patients older than 60 with permanent AF was associated with a positive dynamics of myocardial injury (hsTn) and tissue hemodynamics indexes (Vm и РI). This indicates a possibility for using these indexes for further improvement of managing such patients.",2020,"Concentrations of hsTn significantly decreased in both groups but the decrease was more pronounced in group 1, to 8.0 [4.13; 17.23; p1&lt;0.001] ng / l vs. 9.2 [4.8, 17.5]","['patients older than 60 with permanent AF was associated with a positive dynamics of myocardial injury (hsTn) and tissue hemodynamics indexes (Vm и РI', 'Mean age of patients was 74±7 years', 'elderly patients with permanent atrial fibrillation (AF', 'permanent atrial fibrillation', '75 patients aged ≥60 with permanent AF']",['perindopril and apixaban'],"['myocardial remodeling', 'PIs', 'VCR range goal', 'Troponin I concentration', 'Concentrations of hsTn', 'Vm values', 'VCR decrease and hsTn concentration', 'mean blood flow velocity (Vm) and pulsatility index (PI', 'ventricular contraction rate (VCR).Materials and Methods']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",75.0,0.0461763,"Concentrations of hsTn significantly decreased in both groups but the decrease was more pronounced in group 1, to 8.0 [4.13; 17.23; p1&lt;0.001] ng / l vs. 9.2 [4.8, 17.5]","[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Kanorskiy', 'Affiliation': 'Kuban State Medical University, Ministry of Health of the Russian Federation.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Polischuk', 'Affiliation': 'Kuban State Medical University, Ministry of Health of the Russian Federation.'}]",Kardiologiia,['10.18087/cardio.2020.3.n870']
80,32383196,Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial.,"BACKGROUND


There is no consensus regarding the most effective anaesthetic solution for children; nerve block, especially mandibular, can be difficult for general dentists. Therefore, the study aims to compare the efficacy and the adverse events of articaine 4% with epinephrine 1:100 000 with lidocaine 2% with epinephrine 1:100 000 for primary molar extraction using buccal infiltration.
METHODS


These are data from a parallel triple-blind randomised controlled trial with a computer-generated allocation treatment. Forty-three children aged 6-10 years with a clinical and radiographic indication of primary molar extraction were enrolled. The intervention was local buccal infiltration with articaine 4% compared with lidocaine 2%. The main outcome was pain during anaesthetic injection and tooth extraction. Adverse events were examined as secondary outcomes. Children were treated in a University setting from April to June 2019.
RESULTS


Both solutions had similar anaesthetic efficacy in primary molar extraction when applied by the infiltrative technique (β -0.47; 95% CI -3.19 to 2.24; P = .76); however, children reported higher mean pain during articaine deposition (β 2.43; 95% CI 0.28-4.57; P = .02). The measured lidocaine pH was 3.19 (0.15) and articaine was 2.43 (0.00) (P = .04). Post-operative pain, oedema and nausea were observed without differences between the groups.
CONCLUSIONS


There was no difference in the efficacy of articaine compared to lidocaine for primary molar extraction. Articaine was more painful during the injection.
PRACTICAL IMPLICATIONS


Primary molar extractions can be performed with both articaine and lidocaine buccal infiltration.",2020,"Both solutions had similar anesthetic efficacy in primary molar extraction when applied by the infiltrative technique (β -0.47; 95% CI -3.19 to 2.24; p=0.76), however, children reported higher mean pain during articaine deposition (β 2.43; 95% CI 0.28 to 4.57; p=0.02).","['primary molars extraction using buccal infiltration', 'primary molars extraction', 'Forty-three children aged 6-10 years old with a clinical and radiographic indication of primary molar extraction were enrolled', 'Children were treated in a University setting from April to June 2019']","['Articaine', 'lidocaine', 'articaine', 'articaine and lidocaine buccal infiltration', 'epinephrine']","['anesthetic efficacy', 'pain during anesthetic injection and tooth extraction', 'Adverse events', 'mean pain', 'lidocaine pH', 'Postoperative pain, edema, and nausea', 'Efficacy and adverse events', 'local buccal infiltration']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]",43.0,0.201014,"Both solutions had similar anesthetic efficacy in primary molar extraction when applied by the infiltrative technique (β -0.47; 95% CI -3.19 to 2.24; p=0.76), however, children reported higher mean pain during articaine deposition (β 2.43; 95% CI 0.28 to 4.57; p=0.02).","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Massignan', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Silveira Santos', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Cardoso', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bolan', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Santa Catarina, Florianópolis, Brazil.'}]",Journal of oral rehabilitation,['10.1111/joor.12989']
81,32380138,Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy.,"Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​-0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.",2020,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","['patients suffering from chronic Low Back Pain (cLBP', 'healthy control adults (HC, N=50) and a large sample of cLBP patients (N=102) with']","['acupuncture', 'structural brain imaging (T1-weighted MRI for Voxel Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT', 'verum acupuncture', 'sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control']","['tactile acuity', 'S1-back adjacent white matter FA', '2PDT-back scores', 'Fractional Anisotropy (FA', 'tactile acuity over the back was improved (reduced 2PDT', 'reduced S1-back GMV', 'reduced acuity', 'Gray Matter Volume (GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",102.0,0.102659,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","[{'ForeName': 'Hyungjun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Mawla', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jeungchan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies & Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ""Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA. Electronic address: vitaly@mgh.harvard.edu.""}]",NeuroImage,['10.1016/j.neuroimage.2020.116899']
82,32386040,Therapeutic effect of myofascial trigger point electroacupuncture technology on the treatment of overactive bladder syndrome in female.,"OBJECTIVES


To explore the therapeutic effect of myofascial trigger point electroacupuncture technology on treating female overactive bladder syndrome.
METHODS


Forty female patients with overactive bladder were randomly divided into 2 groups: an experimental group and a control group. The experimental group was treated with myofascial trigger point electroacupuncture therapy combined with solifenacin succinate while the control group was only treated with solifenacin succinate. Patients in both groups were treated for 12 weeks. The overactive bladder symptom score (OABSS), urinary urgency score and urination frequency of 24 h in the 2 groups were compared to analyze the therapeutic effect.
RESULTS


Before the comprehensive treatment, there was no significant difference between the experimental group and the control group ( P >0.05). After 2 and 12 weeks of continuous treatment, the OABSS, urinary urgency symptoms score and 24 h urination frequency in the experimental group and the control group were lower than those before the treatment, and the degree of decline in the experimental group was more obvious, with significant difference ( P <0.05).
CONCLUSIONS


Treating overactive bladder syndrome in women with myofascial trigger point electroacupuncture combined with solifenacin succinate can significantly improve the OABSS and improve the life quality of the patients.",2020,"After 2 and 12 weeks of continuous treatment, the OABSS, urinary urgency symptoms score and 24 h urination frequency in the experimental group and the control group were lower than those before the treatment, and the degree of decline in the experimental group was more obvious, with significant difference ( P <0.05).
","['Forty female patients with overactive bladder', 'women with myofascial trigger point', 'overactive bladder syndrome in female']","['myofascial trigger point electroacupuncture technology', 'myofascial trigger point electroacupuncture therapy combined with solifenacin succinate', 'electroacupuncture', 'solifenacin succinate']","['life quality', 'OABSS, urinary urgency symptoms score and 24 h urination frequency', 'OABSS', 'overactive bladder symptom score (OABSS), urinary urgency score and urination frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1509436', 'cui_str': 'Solifenacin succinate'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}]",40.0,0.0130924,"After 2 and 12 weeks of continuous treatment, the OABSS, urinary urgency symptoms score and 24 h urination frequency in the experimental group and the control group were lower than those before the treatment, and the degree of decline in the experimental group was more obvious, with significant difference ( P <0.05).
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xiong', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China 547732876@qq.com.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Ruting', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Shaodan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Department of Health Management, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Qianyu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China lixh0901@csu.edu.cn.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.180790']
83,32385846,A Randomized Controlled Trial with a Medical Device Containing Sodium Hyaluronate and Nicotinic Acid to Increase the Efficacy of Ultraviolet Phototherapy in Psoriasis.,"INTRODUCTION


The dry and scaly skin of psoriatic patients decreases the efficacy of ultraviolet B (UVB) phototherapy. Different agents are used to facilitate the transmission of light, but most of these preparations are cosmetically unfavorable. We have tested a novel preparation containing sodium hyaluronate and nicotinic acid (UV Fotogel®; Pernix Ltd.) with the double aim to improve the efficacy of UVB phototherapy and assess the cosmetic acceptability of the preparation.
METHODS


Ninety patients with plaque psoriasis were enrolled in the study, of whom 44 received narrow-band UVB (NB-UVB) phototherapy. Prior to phototherapy, one side of the patient's body was treated with UV Fotogel while the other side served as a control. The other 46 patients used the preparation at their homes before regular sunbathing. The Local Psoriasis Severity Index (L-PSI), cosmetic acceptability and tolerability were recorded. The median values with the 25th and 75th percentiles (25p and 75p, respectively) were determined for the UV Fotogel-treated and control sites and then compared.
RESULTS


The sides of the body to which UV Fotogel was applied prior to NB-UVB phototherapy had a significantly lower median L-PSI score than the non-treated control sides at the end of the treatment (1.0 [25p-75p: 0.0-2.0] vs. 2.0 [1.0-3.0], respectively). The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score. There was a significant reduction in the median L-PSI score of patients at the final visit compared to baseline (2.5 [25p-75p: 1.5-3.5] vs. 6.0 [6.0-7.0], respectively). Use of the preparation was not accompanied by considerable adverse effects, and the patients found it cosmetically acceptable. Application of UV Fotogel prior to sunbathing was well tolerated by the patients, and the cosmetic acceptability was also good.
CONCLUSION


UV Fotogel is potentially a useful device for enhancement of the efficacy of phototherapy in patients with psoriasis.",2020,The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score.,"['patients with psoriasis', '46 patients used the preparation at their homes before regular sunbathing', 'Ninety patients with plaque psoriasis were enrolled in the study, of whom 44 received', 'psoriatic patients', 'Psoriasis']","['narrow-band UVB (NB-UVB) phototherapy', 'ultraviolet B (UVB) phototherapy', 'Ultraviolet Phototherapy', 'UVB phototherapy', 'Medical Device Containing Sodium Hyaluronate and Nicotinic Acid']","['median L-PSI score', 'cosmetic acceptability', 'Local Psoriasis Severity Index (L-PSI), cosmetic acceptability and tolerability', 'L-PSI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038813', 'cui_str': 'Sunbathing'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",90.0,0.0219961,The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score.,"[{'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Bende', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Kui', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Annamária', 'Initials': 'A', 'LastName': 'Németh', 'Affiliation': 'Clinical Research Coordination Centre, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Borsos', 'Affiliation': 'Adware Research Ltd., Balatonfüred, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Tóbiás', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Erős', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. eros.gabor@med.u-szeged.hu.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Kemény', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Baltás', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}]",Dermatology and therapy,['10.1007/s13555-020-00385-9']
84,32320845,Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment.,"The quality of child mental health care is highly variable in community practice settings. Innovative technology-based solutions may be leveraged to improve quality of care and, in turn, treatment outcomes. This is a protocol paper that describes an innovative study design in which we rigorously evaluate the effectiveness of a tablet-assisted intervention, Supporting Providers and Reaching Kids (SPARK). SPARK consists of a collection of interactive games and activities that are designed to improve provider fidelity and child engagement in evidence-based psychotherapies. The methodology also allows us to explore the implementation and sustainability of a technology-enhanced intervention in more than two dozen community practice settings. This paper includes a description and justification for sample selection and recruitment procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context. Challenges related to the implementation of a technology-enhanced intervention in existing mental health clinics are discussed, as well as implications for future research and practice.",2020,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,['child mental health treatment'],['tablet-based application'],"['provider fidelity and child engagement', 'quality of care']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",,0.040181,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,"[{'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Anton', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America. Electronic address: antonm@musc.edu.'}, {'ForeName': 'Leigh E', 'Initials': 'LE', 'LastName': 'Ridings', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Hanson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Davidson', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Department of Psychological Science, University of Vermont, John Dewey Hall, Rm 248, 2 Colchester Ave., Burlington, VM 05405, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Kmett Danielson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Chu', 'Affiliation': 'Graduate School of Applied and Professional Psychology, Rutgers University, 152 Frelinghuysen Rd., Piscataway, NJ 08854, United States of America.'}, {'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'Dismuke', 'Affiliation': 'Health Economics Resource Center (HERC), VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA 94025, United States of America.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, School of Medicine, Indiana University, 410 West 10th Street, Indianapolis, IN 46202, United States of America.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106010']
85,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
86,32386922,Stability of acute responses to drugs in humans across repeated testing: Findings with alcohol and amphetamine.,"BACKGROUND


Controlled drug challenge studies provide valuable information about the acute behavioral effects of drugs, including individual differences that may affect risk for abuse. One question that arises in such studies is whether a single administration of a drug (and placebo) provides an accurate measure of response to the drug.
METHODS


Here, we examined data from two studies, one with alcohol and one with amphetamine, in which participants received two administrations of the drug and placebo. In this analysis we assess the stability of acute subjective and cardiovascular responses to the drugs across the two administrations. We examine i) systematic increases or decreases to the drugs from the first to the second administration, ii) test-retest reliability within individuals and iii) the accuracy of the acute drug responses to predict drug choice in a later session.
RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies. Test-retest reliability within individuals was high. Responses during the first drug administration were as accurate in predicting drug choice as responses during both administrations combined.
CONCLUSIONS


Our findings indicate that a single administration of drug (and placebo) provides a good index of an individual's responses to alcohol or amphetamine, when participants are tested under controlled experimental conditions.",2020,"RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.",[],"['drug (and placebo', 'amphetamine', 'placebo']",['stability of acute subjective and cardiovascular responses'],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.0465427,"RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA. Electronic address: hdew@uchicago.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107989']
87,32388522,Photobiomodulation therapy for the management of recurrent aphthous stomatitis in children: clinical effectiveness and parental satisfaction.,"BACKGROUND


This study aims to evaluate the effectiveness of the photobiomodulation therapy (PBMT) in the treatment of minor recurrent aphthous stomatitis (MiRAS) in children, in terms of pain relief, lesion size reduction and the parental satisfaction of the therapy.
MATERIAL AND METHODS


This randomized controlled study was carried out on 60 children with clinical diagnosis of MiRAS. Patients were randomized into two groups: group A receiving laser therapy and group B receiving sham therapy (placebo). Laser therapy (diode laser, λ: 645 nm) was administered on day 1 (T0) for three consecutive days. Patients were evaluated also on day 4 (T1), on day 7 (T2) and on day 10 (T3). Oral aphthous lesions size was assessed through a periodontal probe to measure the diameter length (mm); pain was evaluated through the Visual Analogue Scale (VAS); parental satisfaction was assessed through a questionnaire.
RESULTS


The difference in the reduction of ulcers diameters between the two groups resulted statistically significant at T1 and at T2 (p<0.05). A statistically significant difference in pain reduction between two groups was found at T1 (p<0.05). No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
CONCLUSIONS


PBMT is to be considered effective in the treatment of MiRAS in children and well- accepted by the parents of the children themselves.",2020,"No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
","['60 children with clinical diagnosis of MiRAS', 'minor recurrent aphthous stomatitis (MiRAS) in children', 'children']","['laser therapy and group B receiving sham therapy (placebo', 'Photobiomodulation therapy', 'Laser therapy (diode laser, λ: 645 nm', 'photobiomodulation therapy (PBMT']","['diameter length (mm); pain', 'pain reduction', 'reduction of ulcers diameters', 'Visual Analogue Scale (VAS); parental satisfaction', 'Oral aphthous lesions size']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}]",60.0,0.0304179,"No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bardellini', 'Affiliation': 'Dental Clinic, p.le Spedali Civili n.1 25133 Brescia elena.bardellini@unibs.it.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Veneri', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Majorana', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23573']
88,32388527,"Influence of surgical ultrasound used in the detachment of flaps, osteotomy and odontosection in lower third molar surgeries. A prospective, randomized, and ""split-mouth"" clinical study.","BACKGROUND


As third molar surgery is the most commonly procedure performed in Dentistry and has been accompanied by serious postoperative disorders such as pain, edema and trismus, the study aimed to evaluate if ultrasound device would be able to reduce such postoperative features. The aim of this study was to assess the effects of soft tissue flap elevation, osteotomy and odontosection using piezosurgery versus conventional technique in mandibular third molar extractions.
MATERIAL AND METHODS


Twenty patients with impacted mandibular third molars underwent tooth extractions using two different methods. Ten patients were included in the Piezo Flap Group (PFG - the flap was elevated using piezosurgery) and ten patients were part of the Piezo Ostectomy Group (POG - osteotomy and odontosection were carried out with ultrasound tips). The contralateral tooth was included in the Control Group (CG - conventional technique). The patients were evaluated at postoperative periods of 1, 3, 7 and 14-days. The measured parameters were duration of surgery, pain, trismus and swelling.
RESULTS


The mean duration of surgery for the PFG was 17.21 minutes (CG 10.07 minutes) and POG was 40.09 minutes (CG 15.97 minutes). There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05). There was a statistically significant difference in swelling between the PFG and POG, presenting less swelling at the 3-day postoperative period (p=0.038; p<0,05). However, for the remaining analyzed periods there was no difference (p>0.05).
CONCLUSIONS


Piezosurgery for tissue elevation of the surgical flap, osteotomy and dental sectioning in mandibular third molar extraction surgery promoted less edema in the early postoperative stages in mandibular third molar extractions despite the longer surgical duration.",2020,There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05).,"['Ten patients were included in the', 'Twenty patients with impacted mandibular third molars underwent tooth extractions using two different methods', 'mandibular third molar extractions']","['Piezo Flap Group (PFG - the flap was elevated using piezosurgery', 'surgical ultrasound', 'soft tissue flap elevation, osteotomy and odontosection using piezosurgery versus conventional technique', 'Piezo Ostectomy Group (POG - osteotomy and odontosection were carried out with ultrasound tips']","['pain and trismus', 'duration of surgery, pain, trismus and swelling', 'mean duration of surgery for the PFG', 'swelling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0302269', 'cui_str': 'Excision of bone'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",20.0,0.0692077,There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05).,"[{'ForeName': 'L-D', 'Initials': 'LD', 'LastName': 'Silva', 'Affiliation': 'Department of Surgery and Integrated Clinics Araçatuba School of Dentistry - UNESP Rua José Bonifácio, 1193 CEP 16015-050 São Paulo, Brazil daniela.ponzoni@unesp.br.'}, {'ForeName': 'E-N', 'Initials': 'EN', 'LastName': 'Reis', 'Affiliation': ''}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Bonardi', 'Affiliation': ''}, {'ForeName': 'V-N', 'Initials': 'VN', 'LastName': 'Lima', 'Affiliation': ''}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Aranega', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ponzoni', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23447']
89,32391584,Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: A randomized clinical study.,"AIM


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


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


All groups significantly improved from baseline on both dentine hypersensitivity measures (p < .0001). Difference between adjusted mean changes from baseline in Schiff sensitivity scores at Week 8 for Test versus Negative control groups was 0.19 (95% CI 0.002, 0.374), in favour of the Negative control (p = .0476; 12.57% difference). Difference in tactile threshold was -7.20 g (95% CI -16.376, 1.975), and this was not statistically significant (p = .3715; -21.83% difference). Test group showed no significant difference versus Positive control for either measure. Toothpastes were generally well tolerated.
CONCLUSION


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


Clinicaltrials.gov; NCT03310268.",2020,"Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls.
",[],"['anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control', 'anhydrous stannous fluoride toothpaste']","['dentine hypersensitivity', 'tolerated', 'mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe', 'dentine hypersensitivity relief', 'dentine hypersensitivity measures', 'Schiff sensitivity scores']",[],"[{'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C1247980', 'cui_str': 'Sodium Fluoride Toothpaste'}, {'cui': 'C0142890', 'cui_str': 'sodium monofluorophosphate'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1253019', 'cui_str': 'Stannous Fluoride Toothpaste'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0429399', 'cui_str': 'Tactile threshold'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.132493,"Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls.
","[{'ForeName': 'Danying', 'Initials': 'D', 'LastName': 'Tao', 'Affiliation': ""Department of Preventative Dentistry, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Ling', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}, {'ForeName': 'Xi-Ping', 'Initials': 'XP', 'LastName': 'Feng', 'Affiliation': ""Department of Preventative Dentistry, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gallob', 'Affiliation': 'Consumer Research Consulting, LLC, Las Vegas, NV, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Souverain', 'Affiliation': 'GSK Consumer Healthcare, Nyon, Switzerland.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Preventative Dentistry, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Anousheh', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}]",Journal of clinical periodontology,['10.1111/jcpe.13305']
90,32387014,[Repurposing of chlorpromazine in COVID-19 treatment: the reCoVery study].,"OBJECTIVES


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


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


This repositioning of CPZ as an anti-SARS-CoV-2 drug offers an alternative and rapid strategy to alleviate the virus propagation and the infection severity and lethality. This CPZ repositioning strategy also avoids numerous developmental and experimental steps and can save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easy to manage side effects. Indeed, CPZ is an FDA-approved drug with an excellent tolerance profile, prescribed for around 70 years in psychiatry but also in clinical routine in nausea and vomiting of pregnancy, in advanced cancer and also to treat headaches in various neurological conditions. The broad spectrum of CPZ treatment - including antipsychotic, anxiolytic, antiemetic, antiviral, immunomodulatory effects along with inhibition of clathrin-mediated endocytosis and modulation of blood-brain barrier - is in line with the historical French commercial name for CPZ, i.e. LARGACTIL, chosen as a reference to its ""LARGe ACTion"" properties. The discovery of those CPZ properties, as for many other molecules in psychiatry, is both the result of serendipity and careful clinical observations. Using this approach, the field of mental illness could provide innovative therapeutic approaches to fight SARS-CoV-2.",2020,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,['psychiatric patients'],"['Chlorpromazine (CPZ', 'CPZ', 'chlorpromazine', 'phenothiazine derivative']","['biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia', 'parenchymal involvement (chest CT', 'shorter time to response (TTR']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0622901,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research university, université Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 evolutionary genomics of RNA viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France; GHU PARIS Psychiatrie et Neurosciences, site Sainte-Anne, service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.04.010']
91,32387091,The clinical utility of apoB versus LDL-C/non-HDL-C.,"BACKGROUND


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


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


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


We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",2020,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",[],['apoB versus LDL-C/non-HDL-C'],[],[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",[],,0.0221709,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.","[{'ForeName': 'Ciaran N', 'Initials': 'CN', 'LastName': 'Kohli-Lynch', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA; Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Sniderman', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada. Electronic address: allansniderman@hotmail.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.05.001']
92,32393616,Correction: Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial.,,2020,,['insomnia with short sleep duration'],['Correction: Acupuncture'],[],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.208285,,[],BMJ open,['10.1136/bmjopen-2019-033731corr1']
93,32332564,"The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.",,2020,,['after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",['Transversus Abdominis Plane Block'],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.200618,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic Division of Plastic Surgery, MetroHealth Department of Plastic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
94,32333060,Letter to the editor: Impact of postoperative instructions on physical activity following pelvic reconstructive surgery: a randomized controlled trial.,,2020,,['pelvic reconstructive surgery'],['postoperative instructions'],['physical activity'],"[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.175555,,"[{'ForeName': 'Chih-Ting', 'Initials': 'CT', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kun-Ling', 'Initials': 'KL', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Long', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. urolong@yahoo.com.tw.'}]",International urogynecology journal,['10.1007/s00192-020-04316-2']
95,32244170,Endogenous in-session cortisol during exposure therapy predicts symptom improvement: Preliminary results from a scopolamine-augmentation trial.,"The purpose of this study was to explore whether individual differences in glucocorticoid concentrations were associated with symptom improvement following exposure therapy for patients with social anxiety disorder. To do this, 60 participants with social anxiety disorder completed a randomized-controlled trial of exposure therapy, where participants were randomized to receive scopolamine-augmentation or placebo during their 7 exposure sessions. Scopolamine is an antimuscarinic which blocks the effects of acetylcholine and reduces autonomic arousal. During sessions 1, 4, 7, and during the post-treatment extinction assessment, participants provided up to 16 saliva samples (4 in each session). Pre-treatment, post-treatment, and at 1-month follow-up, participants completed the Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms. Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up. The association between elevated endogenous in-session cortisol and attenuated symptom change was not moderated by scopolamine treatment condition. Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy. This is the first study, to our knowledge, to examine whether endogenous in-session cortisol concentrations predict symptom changes following exposure therapy for the treatment of social anxiety disorder. More investigation of non-invasive and reliable biological markers that explain variability in responses to effective treatments are needed.",2020,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"['patients with social anxiety disorder', 'social anxiety disorder', '60 participants with social anxiety disorder', 'Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy']","['acetylcholine', 'Scopolamine', 'scopolamine', 'scopolamine-augmentation or placebo', 'exposure therapy']","['Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms', 'symptom improvement', 'autonomic arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",60.0,0.01704,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"[{'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Kuhlman', 'Affiliation': 'Department of Psychological Science, University of California Irvine, Irvine, CA, 92697, United States; Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Institute for Interdisciplinary Salivary Bioscience, University of California Irvine, Irvine, CA, 92697, United States. Electronic address: krkuhl@uci.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Imbriano', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Department of Psychology, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104657']
96,32398091,A randomised controlled crossover trial investigating the short-term effects of different types of vegetables on vascular and metabolic function in middle-aged and older adults with mildly elevated blood pressure: the VEgetableS for vaScular hEaLth (VESSEL) study protocol.,"BACKGROUND


A diet rich in fruits and vegetables is recommended for cardiovascular health. However, the majority of Australians do not consume the recommended number of vegetable servings each day. Furthermore, intakes of vegetables considered to have the greatest cardiovascular benefit are often very low. Results from prospective observational studies indicate that a higher consumption of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower) is associated with lower cardiovascular disease risk. This may be due to the presence of specific nutrients and bioactive compounds found almost exclusively, or at relatively high levels, in cruciferous vegetables. Therefore, the aim of this randomised controlled crossover trial is to determine whether regular consumption of cruciferous vegetables results in short-term improvement in measures related to cardiovascular disease risk, including ambulatory blood pressure, arterial stiffness, glycaemic control, and circulating biomarkers of oxidative stress and inflammation.
METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period. During the intervention period, participants will consume 4 servings (~ 300 g) of cruciferous vegetables per day as a soup (~ 500-600 mL/day). The 'control' soup will consist of other commonly consumed vegetables (potato, sweet potato, carrot, pumpkin). Both soups will be approximately matched for energy, protein, fat, and carbohydrate content. All measurements will be performed at the beginning and end of each intervention period.
DISCUSSION


The findings of this study will provide evidence regarding the potential cardiometabolic health benefits of cruciferous vegetables, which may contribute to the revision of dietary and clinical guidelines.
TRIAL REGISTRATION


The trial was registered with the Australian New Zealand Clinical Trial Registry on 19th September 2019 (ACTRN12619001294145).",2020,"METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period.","['Twenty-five participants (50-75\u2009years) with mildly elevated blood pressure (systolic blood pressure 120-160\u2009mmHg', 'middle-aged and older adults with mildly elevated blood pressure']","['cruciferous vegetables', 'regular consumption of cruciferous vegetables']","['vascular and metabolic function', 'ambulatory blood pressure, arterial stiffness, glycaemic control, and circulating biomarkers of oxidative stress and inflammation']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0453113', 'cui_str': 'Brassica vegetable'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",25.0,0.0701994,"METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period.","[{'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Connolly', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Radavelli-Bagatini', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Croft', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Boyce', 'Affiliation': 'Centre for Integrative Metabolomics and Computational Biology, School of Science, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'James', 'Affiliation': 'School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Reindolf', 'Initials': 'R', 'LastName': 'Anokye', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Seng Khee', 'Initials': 'SK', 'LastName': 'Gan', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Schultz', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Mithen', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Blekkenhorst', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia. l.blekkenhorst@ecu.edu.au.'}]",Nutrition journal,['10.1186/s12937-020-00559-3']
97,32336038,"Safety and Efficacy of Lenabasum in a Phase II, Randomized, Placebo-Controlled Trial in Adults With Systemic Sclerosis.","OBJECTIVE


To assess the safety and efficacy of lenabasum in diffuse cutaneous systemic sclerosis (dcSSc).
METHODS


A randomized, double-blind, placebo-controlled, phase II study was conducted at 9 SSc clinics in the US. Adults with dcSSc of ≤6 years' duration who were receiving stable standard-of-care treatment were randomized to receive lenabasum (n = 27) or placebo (n = 15). Lenabasum doses were 5 mg once daily, 20 mg once daily, or 20 mg twice daily for 4 weeks, followed by 20 mg twice daily for 8 weeks. Safety and efficacy were assessed at weeks 4, 8, 12, and 16.
RESULTS


Adverse events (AEs) occurred in 63% of the lenabasum group and 60% of the placebo group, with no serious AEs related to lenabasum. Compared to placebo, lenabasum treatment was associated with greater improvement in the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcome measures that assessed overall disease, skin involvement, and patient-reported function. The median CRISS score increased in the lenabasum group during the study, reaching 0.33, versus 0.00 in the placebo group, at week 16 (P = 0.07 by 2-sided mixed-effects model repeated-measures analysis). Gene expression in inflammation and fibrosis pathways was reduced, and inflammation and fibrosis were improved on histologic evaluation of skin biopsy specimens, in the lenabasum group compared to the placebo group (all P ≤ 0.05).
CONCLUSION


Despite a short trial duration in a small number of patients in this phase II study in dcSSc, our findings indicate that lenabasum improves efficacy outcomes and underlying disease pathology with a favorable safety profile.",2020,"Lenabasum treatment compared to placebo was associated with greater improvement in American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcomes that assessed overall disease, skin involvement, and patient-reported function.","['Adults with dcSSc ≤ 6 years duration on stable standard-of-care treatment received lenabasum (N = 27) or', 'adults with systemic sclerosis', 'diffuse cutaneous systemic sclerosis (dcSSc', 'nine SSc clinics in the USA']","['placebo', 'lenabasum']","['American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score', 'Safety and efficacy', 'Gene expression in inflammation and fibrosis pathways', 'Adverse events', 'CRISS score', 'Safety and efficacy assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.474232,"Lenabasum treatment compared to placebo was associated with greater improvement in American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcomes that assessed overall disease, skin involvement, and patient-reported function.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hummers', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, and Palo Alto VA Health Care System, Palo Alto, California.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Frech', 'Affiliation': 'University of Utah, and Salt Lake City VA Health Care System.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Domsic', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Hsu', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Arthritis Association of Southern California, Los Angeles, California.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mayes', 'Affiliation': 'University of Texas Health Science Center at Houston.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Simms', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lafyatis', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Martyanov', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Tammara', 'Initials': 'T', 'LastName': 'Wood', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Whitfield', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Constantine', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Dgetluck', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'White', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41294']
98,32272255,COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.,"BACKGROUND


Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown.
HYPOTHESIS


The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose.
STUDY DESIGN


COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours.
CONCLUSIONS


The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.",2020,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"['patients with ST elevation myocardial infarction (STEMI', 'patients with STEMI undergoing primary percutaneous coronary interventions', 'approximately 674 patients presenting with STEMI planned for primary PCI', 'patients presenting with STEMI planned for primary PCI', 'STEMI patients undergoing primary percutaneous coronary intervention (PCI']","['Prasugrel tablets', 'prasugrel crushed tablets']","['death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year', 'bleeding events', 'percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C2710119', 'cui_str': 'prasugrel Oral Tablet'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]",674.0,0.146697,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"[{'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Maasstad Hospital, Rotterdam; University Medical Center Utrecht, Netherlands. Electronic address: g.vlachojannis@umcutrecht.nl.'}, {'ForeName': 'Rosanne F', 'Initials': 'RF', 'LastName': 'Vogel', 'Affiliation': 'University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Wilschut', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Miguel E', 'Initials': 'ME', 'LastName': 'Lemmert', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Academic Medical Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'van Vliet', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'van der Waarden', 'Affiliation': 'Ambulance Zorg Rotterdam-Rijnmond, Rotterdam, Netherlands.'}, {'ForeName': 'Rutger-Jan', 'Initials': 'RJ', 'LastName': 'Nuis', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Paradies', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Group, Groupe Hospitalier Pitie-Salpetriere Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}]",American heart journal,['10.1016/j.ahj.2020.03.005']
99,32244028,Network topology and machine learning analyses reveal microstructural white matter changes underlying Chinese medicine Dengzhan Shengmai treatment on patients with vascular cognitive impairment.,"With the increasing incidence of cerebrovascular diseases and dementia, considerable efforts have been made to develop effective treatments on vascular cognitive impairment (VCI), among which accumulating practice-based evidence has shown great potential of the traditional Chinese medicine (TCM). Current randomized double-blind controlled trial has been designed to evaluate the 6-month treatment effects of Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations on VCI, and to explore the underlying neural mechanisms with graph theory-based analysis and machine learning method based on diffusion tensor imaging (DTI) data. A total of 82 VCI patients were recruited and randomly assigned to drug (45 with DZSM) and placebo (37 with placebo) groups, and neuropsychological and neuroimaging data were acquired at baseline and after 6-month treatment. After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains. And with the reconstruction of white matter structural network, there were more streamlines connecting the left thalamus and right hippocampus in the drug groups (p < 0.001 uncorrected), with decreasing nodal efficiency of the right olfactory associated with slower decline in the general cognition (r = -0.364, p = 0.048). Moreover, support vector machine classification analyses revealed significant white matter network alterations after treatment in the drug groups (accuracy of baseline vs. 6-month later, 68.18 %). Taking together, the present study showed significant efficacy of DZSM treatment on VCI, which might result from white matter microstructure alterations and the topological changes in brain structural network.",2020,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","['82 VCI patients', 'patients with vascular cognitive impairment']","['Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations', 'placebo', 'Network topology and machine learning', 'placebo (37 with placebo', 'DZSM']","['general cognition', 'white matter network alterations', 'nodal efficiency', ""performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}]","[{'cui': 'C3885966', 'cui_str': 'shengmai'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002812', 'cui_str': 'Regional Anatomy'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.257526,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, Beijing, 100069, PR China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'China-Japan Friendship Hospital 100029, PR China.'}, {'ForeName': 'Caishui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Xuwen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Wenxiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Shaokun', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China. Electronic address: chengweidong888@sina.com.'}, {'ForeName': 'Zhanjun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China. Electronic address: zhang_rzs@bnu.edu.cn.'}]",Pharmacological research,['10.1016/j.phrs.2020.104773']
100,32397219,Changes in Gait Performance in Stroke Patients after Taping with Scapular Setting Exercise.,"The purpose of this study was to investigate the effects of combined taping with scapular setting exercise on the gait performance of stroke patients. Twenty stroke patients were randomly allocated to two groups: the taping with scapular setting exercise (TSSE) group ( n  = 10) and scapular setting exercise (SSE) group ( n  = 10). Intervention was performed for one week, and pre- and postintervention results for TSSE and SSE were compared. Outcomes were determined using the inertia measurement unit, which can measure spatiotemporal gait parameters, and using the timed up-and-go test. Two-way repeated analysis was used to compare pre- and postintervention results. In the TSSE group, intervention significantly improved cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results more than in the SSE group. TSSE was found to improve all spatiotemporal gait parameters examined; thus, we recommend TSSE be considered as an intervention to improve gait parameters in stroke patients.",2020,"In the TSSE group, intervention significantly improved cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results more than in the SSE group.","['stroke patients', 'Stroke Patients after Taping with Scapular Setting Exercise', 'Twenty stroke patients']","['taping with scapular setting exercise (TSSE) group ( n  = 10) and scapular setting exercise (SSE', 'TSSE', 'combined taping with scapular setting exercise']","['gait performance', 'Gait Performance', 'gait parameters', 'cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}]",20.0,0.0156449,"In the TSSE group, intervention significantly improved cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results more than in the SSE group.","[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do, 27600, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 330-714, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020128']
101,32302788,Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): A cluster randomized trial of a computerized clinical decision support tool.,"BACKGROUND


Clinical decision support (CDS) tools designed to digest, filter, organize, and present health data are becoming essential in providing clinical and cost-effective care. Many are not rigorously evaluated for benefit before implementation. We assessed whether computerized CDS for primary care providers would improve atrial fibrillation (AF) management and outcomes as compared to usual care.
METHODS


Overall, 203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n = 99) or CDS (n = 104). Providers recruited 1,145 adult patients with AF to participate. The intervention was access to an evidenced-based, point-of-care computerized CDS designed to support guideline-based AF management. The primary efficacy outcome was a composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year. Patients were the units of intention-to-treat analysis.
RESULTS


No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
CONCLUSIONS


IMPACT-AF rigorously assessed a CDS tool in a highly representative sample of primary care providers and their patients; however, no impact on outcomes was observed. Considering the proliferating use of CDS applications, this study highlights the need for efficacy assessments prior to adoption and clinical implementation.",2020,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","['1,145 adult patients with AF to participate', 'Atrial Fibrillation (IMPACT-AF', '203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n\u202f=\u202f99) or CDS (n\u202f=\u202f104']",['computerized CDS'],"['atrial fibrillation (AF) management and outcomes', 'composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year', 'primary efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1145.0,0.0610574,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","[{'ForeName': 'Jafna L', 'Initials': 'JL', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada; Heart and Stroke Foundation of Nova Scotia Endowed Chair in Cardiovascular Outcomes Research, Halifax, Nova Scotia, Canada. Electronic address: jafna.cox@dal.ca.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Foster', 'Affiliation': ""Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'MacKillop', 'Affiliation': 'Sydney Primary Care Medical Clinic, Sydney, Nova Scotia, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ciaccia', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Shurjeel H', 'Initials': 'SH', 'LastName': 'Choudhri', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hamilton', 'Affiliation': 'QEII Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Nemis-White', 'Affiliation': 'Strive Health Management Consulting Ltd, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Departments of Anesthesia/Pediatrics, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, Centre for Evaluation of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute (PHRI), Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.019']
102,32396535,"Proficiency based progression simulation training significantly reduces utility strikes; A prospective, randomized and blinded study.","OBJECTIVES


We evaluated a simulation-based training curriculum with quantitatively defined performance benchmarks for utility workers location and excavation of utility services.
BACKGROUND


Damaging buried utilities is associated with considerable safety risks to workers and substantial cost to employers.
METHODS


In a prospective, randomized and blinded study we assessed the impact of Proficiency Based Progression (PBP) simulation training on the location and excavation of utility services work.
RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group. When implemented across all workers in the same division there was a 35-61% reduction in utility strikes (p = 0.028) and an estimated cost saving of £116,000 -£2,175,000 in the 12 months (47,000 work hours) studied.
CONCLUSIONS


The magnitude of the training benefit of PBP simulation training in the utilities sector appears to be the same as it is in surgery, cardiology and procedure-based medicine.
APPLICATION


Quality-assured utility worker simulation training significantly reduces utility damage and associated costs.",2020,"RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group.",[],"['Proficiency based progression simulation training', 'PBP simulation training', 'Proficiency Based Progression (PBP) simulation training']","['performance errors', 'utility strikes']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]",,0.038472,"RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group.","[{'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Faculty of Life and Health Sciences, Ulster University, Magee Campus, Londonderry, Northern Ireland, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': 'Group Training and Development Manager, ReachActive Unit 4B Lough Sheever Corporate Park, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cleary', 'Affiliation': 'ReachActive, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hamilton', 'Affiliation': 'ReachActive, Hertford, England, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGlinchey', 'Affiliation': 'ReachActive, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kiely', 'Affiliation': 'Flux Learning Ltd., Clonakilty, Co Cork, Ireland.'}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Bunting', 'Affiliation': 'School of Psychology, Coleraine, Co. Londonderry, Northern Ireland, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0231979']
103,32335270,"The effect of acute intragastric vs. intravenous alcohol administration on inflammation markers, blood lipids and gallbladder motility in healthy men.","Ethanol intake increases plasma concentrations of triglycerides and chronic ethanol use impairs lipid metabolism and causes chronic inflammation. The gut plays an important role in metabolic handling of nutrients, including lipids, and a leaky gut associated with alcohol intake, allowing inflammatory signals to the portal vein, has been proposed to constitute a mechanism by which ethanol induces hepatic inflammation. We compared the effects of enteral and parenteral administration of ethanol on a range of circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19) as well as gallbladder volume. On two separate and randomized study days, we subjected healthy men (n = 12) to double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI). Blood was sampled and ultrasonographic evaluation of gallbladder volume was performed at frequent intervals for 4 h after initiation of ethanol administration on both days. Little or no effects were observed on plasma levels of inflammation markers during IGEI and IVEI, respectively. Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form. Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations increased more after IGEI compared to IVEI. IVEI had no effect on plasma CCK and caused an increased gallbladder volume whereas IGEI elicited a CCK response (P < 0.0001) without affecting gallbladder volume. Circulating FGF19 concentrations decreased equally in response to both ethanol administration forms. In conclusion, by evaluating a range of circulating inflammation markers during IGEI and IVEI we were not able to detect signs of systemic low-grade inflammation originating from the presence of ethanol in the gut. IVEI increased gallbladder volume whereas IGEI increased plasma CCK (with neutral effect on gallbladder volume), increased plasma VLDL cholesterol and triglyceride concentrations; indicating that the enteral route of administration may influence ethanol's effects on lipid metabolism.",2020,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","['healthy men', 'subjected healthy men (n=12) to']","['double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI', 'Ethanol intake', 'acute intragastric vs. intravenous alcohol', 'ethanol']","['Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations', 'plasma VLDL cholesterol and triglyceride concentrations', 'inflammation markers, blood lipids and gallbladder motility', 'Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol', 'lipid metabolism', 'plasma levels of inflammation markers', 'IVEI increased gallbladder volume whereas IGEI increased plasma CCK', 'gallbladder volume', 'Circulating FGF19 concentrations', 'plasma CCK', 'circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C1431711', 'cui_str': 'FGF19 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0022801', 'cui_str': 'Kupffer cell'}]",,0.130521,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","[{'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gillum', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Holger J', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark. Electronic address: filipknop@dadlnet.dk.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2020.04.006']
104,32337693,Effect of Sheng Xue Ning Tablets on Renal Anemia in Patients Subject to Maintenance Hemodialysis and Safety Evaluation: A Multi-setting Prospective Randomized Study.,"This study compared Sheng Xue Ning (SXN) tablets with ferrous succinate (FS) tablets in terms of their efficacy for the treatment of iron-deficient renal anemia and safety in patients subject to maintenance hemodialysis (MHD). A total of 94 patients undergoing MHD were randomly assigned to an experiment group (receiving oral SXN tablets, SXN group) and a control group (orally given FS tablets, FS group) and followed up for 12 weeks. Erythropoietin (EPO) was used in both groups. The efficacy was assessed by detecting the subsequent changes in hemoglobin (Hb), serum iron (SI), SF and transferrin saturation (TSAT). At the 12th week, Hb and TSAT levels in both groups were significantly increased compared to those in the screening period (P<0.05). However, no significant difference in Hb and TSAT was found between the two groups. The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week. Our study showed that SXN tablets can effectively ameliorate renal anemia and keep iron metabolism stable in MHD patients, and its efficacy is virtually close to that of FS tablets. Meanwhile, SXN tablets can reduce the dosage of EPO and have a good safety profile.",2020,The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week.,"['MHD patients', '94 patients undergoing MHD', 'patients subject to maintenance hemodialysis (MHD', 'Patients Subject to Maintenance Hemodialysis and Safety Evaluation']","['Sheng Xue Ning Tablets', 'experiment group (receiving oral SXN tablets, SXN', 'Sheng Xue Ning (SXN) tablets with ferrous succinate (FS) tablets', 'Erythropoietin (EPO', 'SXN tablets']","['hemoglobin (Hb), serum iron (SI), SF and transferrin saturation (TSAT', 'Hb and TSAT', 'Hb and TSAT levels', 'renal anemia', 'Renal Anemia', 'average weekly EPO dosage']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0060281', 'cui_str': 'ferrous succinate'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1142276', 'cui_str': 'Renal anemia'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",94.0,0.0117874,The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week.,"[{'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, Changzheng Hospital, the Second Military Medical University, Shanghai, 20003, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Rong', 'Affiliation': 'Department of Nephrology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China.'}, {'ForeName': 'Chang-Lin', 'Initials': 'CL', 'LastName': 'Mei', 'Affiliation': 'Department of Nephrology, Changzheng Hospital, the Second Military Medical University, Shanghai, 20003, China. chlmei1954@126.com.'}, {'ForeName': 'Zhao-Hui', 'Initials': 'ZH', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, Jiaotong University, Shanghai, 200003, China.'}, {'ForeName': 'Geng-Ru', 'Initials': 'GR', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, Xinhua Hospital, Jiaotong University, Shanghai, 200092, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Yuan', 'Affiliation': 'Department of Nephrology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China.'}, {'ForeName': 'Nian-Song', 'Initials': 'NS', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, the Sixth People's Hospital, Jiaotong University, Shanghai, 200233, China.""}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, Changhai Hospital, the Second Military Medical University, Shanghai, 200433, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Tongji Hospital, Tongji University, Shanghai, 200065, China.'}, {'ForeName': 'Hai-Dong', 'Initials': 'HD', 'LastName': 'Yan', 'Affiliation': 'Department of Nephrology, East Hospital, Tongji University, Shanghai, 200120, China.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'ZHang', 'Affiliation': 'Department of Nephrology, Zhabei District Central Hospital, Changzhen Hospital, Shanghai, 200070, China.'}]",Current medical science,['10.1007/s11596-020-2179-z']
105,32337698,Efficacy of Electro-acupuncture in Treatment of Functional Constipation: A Randomized Controlled Trial.,"Functional constipation (FC) is a chronic disease that significantly affects the life quality of patients. Acupuncture has been used for the treatment of FC for many years, but its effectiveness has not been scientifically assessed. The present study aimed to evaluate the efficacy of electro-acupuncture (EA) in relieving the symptoms, mental states and quality of life (QOL) of FC patients. A total of 96 FC patients were randomly allocated into EA, mosapride & sham EA group (MS) and mosapride control group (MC). In the EA group, patients were treated with 16 sessions of needling at Quchi (LI11) and Shangjuxu (ST37) bilaterally, 5 times a week in the first 2 weeks, and 3 times a week in the last 2 weeks. In the MC group, patients were treated with 5 mg mosapride citrate three times a day for 4 weeks. In the MS group, patients underwent sham EA and the same mosapride citrate treatment as in the MC group. The primary outcome was the number of weekly spontaneous bowel movements (SBMs). The secondary outcomes included stool consistency, intensity of defecating difficulty, 36-Item Short-Form Health Survey (SF-36), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation-Quality of Life (PAC-QOL). The results showed that as compared with the baseline, EA significantly improved the weekly SBMs, stool consistency and intensity of defecating difficulty (P<0.05). It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05). However, no significant difference was observed between MS and MC groups in bowel function outcomes and QOL scores. It was concluded that EA could effectively improve bowel function, mental states and QOL of FC patients.",2020,"It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05).","['96 FC patients', 'Functional Constipation']","['electro-acupuncture (EA', 'EA, mosapride & sham', 'Acupuncture', 'Electro-acupuncture', 'EA']","['bowel function outcomes and QOL scores', 'bowel function, mental states and QOL', 'stool consistency, intensity of defecating difficulty, 36-Item Short-Form Health Survey (SF-36), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation-Quality of Life (PAC-QOL', 'number of weekly spontaneous bowel movements (SBMs', 'weekly SBMs, stool consistency and intensity of defecating difficulty', 'symptoms, mental states and quality of life (QOL', 'Functional constipation (FC', 'PAC-QOL, SF-36, SDS and SAS scores']","[{'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0526501', 'cui_str': 'mosapride'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]",96.0,0.0313138,"It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05).","[{'ForeName': 'Xiao-Hu', 'Initials': 'XH', 'LastName': 'Xu', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Ming-Min', 'Initials': 'MM', 'LastName': 'Zhang', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Sha-Bei', 'Initials': 'SB', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. chzheng@tjh.tjmu.edu.cn.'}, {'ForeName': 'Guang-Ying', 'Initials': 'GY', 'LastName': 'Huang', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. gyhuang@tjh.tjmu.edu.cn.'}]",Current medical science,['10.1007/s11596-020-2188-y']
106,32337700,Effect of Nalmefene on Delayed Neurocognitive Recovery in Elderly Patients Undergoing Video-assisted Thoracic Surgery with One Lung Ventilation.,"The intravenous use of nalmefene has been found to exert neuroprotective effect in patients with severe traumatic brain injury and acute cerebral infarction; nonetheless, it is unknown whether nalmefene alleviates delayed neurocognitive recovery. Our purpose of the current research was to clarify the impact of nalmefene on delayed neurocognitive recovery in aged patients experiencing video-assisted thoracic surgery (VATS) with intraoperative use of one lung ventilation (OLV). The present study involved 120 patients undergoing selective VATS, randomized to accept low-dose nalmefene (N1 group, n=40), high-dose nalmefene (N2 group, n=40) or equal volume of physiologic saline (control group, n=40). A battery of neuropsychological tests were used to estimate cognitive function 1 day before surgery (t 0 ) and 10 days after surgery or before discharge (t 1 ). Regional cerebral oxygen saturation (rSO 2 ) was detected 5 min before induction (t 0 ), 5 min after induction (t 1 ), 15 and 60 min after onset of OLV (t 2  and t 3 ), and 15 min after termination of OLV (t 4 ). The plasma values of interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α and adiponectin (ADP) were also detected prior to induction of anesthesia (T0), 1 h, 2 h and 6 h after surgery (T1, T2, T3). On t 1 , delayed neurocognitive recovery occurred in 5/40 (12.5%) patients of N1 group, in 5/40 (12.5%) patients of N2 group and in 13/40 (32.5%) patients of control group (P0.05). There were no statistical differences in rSO 2  among three groups at different time points. At T1, T2 and T3, IL-1β, IL-6 and TNF-α values significantly increased and ADP value significantly decreased (P0.05) in control group. In contrast, at T1, T2 and T3, IL-1β, IL-6 and TNF-α values decreased and ADP value decreased less in N1 and N2 groups (P0.05). At T1, T2 and T3, IL-1β, IL-6 and TNF-α concentrations presented a trend of N2 group N1 group control group and ADP presented a trend of N2 groupN1 groupcontrol group (P0.05). The result of our present research supports the hypothesis that the perioperative intravenous treatment with nalmefene to VATS with OLV ameliorates postoperative cognitive function and decreases the incidence of delayed neurocognitive recovery, most likely by suppression of inflammatory responses.",2020,"At T1, T2 and T3, IL-1β, IL-6 and TNF-α concentrations presented a trend of N2 group N1 group control group and ADP presented a trend of N2 groupN1 groupcontrol group (P0.05).","['patients with severe traumatic brain injury and acute cerebral infarction', 'aged patients experiencing video-assisted thoracic surgery (VATS) with intraoperative use of one lung ventilation (OLV', 'Elderly Patients Undergoing Video-assisted Thoracic Surgery with One Lung Ventilation', '120 patients undergoing selective VATS, randomized to accept low-dose nalmefene (N1 group, n=40']","['Nalmefene', 'high-dose nalmefene (N2 group, n=40) or equal volume of physiologic saline (control']","['T2 and T3, IL-1β, IL-6 and TNF-α values', 'delayed neurocognitive recovery', 'ADP value', 'plasma values of interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α and adiponectin (ADP', 'Regional cerebral oxygen saturation (rSO 2 ', 'T2 and T3, IL-1β, IL-6 and TNF-α concentrations', 'postoperative cognitive function', 'T2 and T3, IL-1β, IL-6 and TNF-α values decreased and ADP value', 'Delayed Neurocognitive Recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",120.0,0.0301072,"At T1, T2 and T3, IL-1β, IL-6 and TNF-α concentrations presented a trend of N2 group N1 group control group and ADP presented a trend of N2 groupN1 groupcontrol group (P0.05).","[{'ForeName': 'Meng-Yun', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Zheng-Gang', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Jian-Juan', 'Initials': 'JJ', 'LastName': 'Ke', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital, Wuhan University, Wuhan, 430071, China. 283647213@qq.com.'}]",Current medical science,['10.1007/s11596-020-2170-8']
107,32397852,Topical Alpha-1 Adrenergic Receptor Agonist Applied to the Nipple/Areola Complex Improves Female Orgasmic Function.,"Background:  The impact of nipple sensation and its relationship to sexual function have often been neglected in medical literature. However, several recent studies report the importance of the nipple/areola complex (NAC) in sexual arousal and overall function. The nipple is composed of smooth muscle that can be erected  via  adrenergic nerves. In two complementary studies, we demonstrate that stimulation of the alpha-1 adrenergic receptor in the NAC with topical adrenergic agents can initiate erection of the nipple, increase NAC sensitivity, and improve sexual function.  Materials and Methods:  Thirteen breast surgery patients with nipple sensitivity loss were recruited to an unblinded study of topical phenylephrine hydrochloride. Sensitivity to pressure was measured before and after the application of the intervention to the NAC. In a second pilot study, 35 women completed a double-blinded placebo-controlled trial of a novel formulation, RJ101, containing a norepinephrine releasing agent. The intervention or placebo was applied to the NAC 30 minutes before sexual activity over the 4-week trial period. The arousal, lubrication, and orgasm domains of the female sexual function index (FSFI) were used to measure sexual function.  Results:  The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients. In addition, it was shown that intermittent application of the alpha-1 agonist for 8 weeks increased basal NAC sensitivity. In the follow-up pilot study, we demonstrate that stimulation of the NAC with RJ101 produced statistically significant increases versus placebo in the lubrication and orgasm domains of the FSFI,  p  = 0.0226 and  p  = 0.0269, respectively.  Conclusion:  For the first time, we demonstrate that the application of a topical alpha-1 adrenergic receptor agonist or a norepinephrine-releasing agent increases the sensitivity of the NAC and subsequently significantly improves sexual function.",2020,The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients.,"['13 breast augmentation patients', 'Thirteen breast surgery patients with nipple sensitivity loss', '35 women completed a double-blinded']","['phenylephrine hydrochloride', 'topical phenylephrine hydrochloride', 'norepinephrine releasing agent', 'placebo']","['basal NAC sensitivity', 'sexual function', 'nipple sensitivity to pressure', 'Sensitivity to pressure', 'arousal, lubrication, and orgasm domains of the female sexual function index (FSFI']","[{'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0031470', 'cui_str': 'Phenylephrine hydrochloride'}, {'cui': 'C3212565', 'cui_str': 'Phenylephrine-containing product in cutaneous dose form'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",35.0,0.0262157,The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients.,"[{'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Goren', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCoy', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krychman', 'Affiliation': 'Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, California, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'Amadej', 'Initials': 'A', 'LastName': 'Lah', 'Affiliation': 'Estetika Fabjan D.O.O., Kranj, Slovenia.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Lonky', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Irvine, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2019.8188']
108,32280035,Adolescent cognitive control and mediofrontal theta oscillations are disrupted by neglect: Associations with transdiagnostic risk for psychopathology in a randomized controlled trial.,"Children that have experienced psychosocial neglect display impairments in self-monitoring and controlling their behavior (cognitive control) and are at broad, transdiagnostic risk for psychopathology. However, the neural underpinnings of such effects remain unclear. Event-related mediofrontal theta oscillations reflect a neural process supporting cognitive control that may relate to transdiagnostic psychopathology risk. Recent work demonstrates reduced mediofrontal theta in rodent models of neglect; however, similar findings have not been reported in humans. Here, 136 children reared in Romanian institutions were randomly assigned to either a high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group. The intervention ended at 54 months; event-related mediofrontal theta and psychopathology were assessed at 12- and 16-year follow-up assessments. Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for. Earlier placement into foster care yielded greater mediofrontal activity by age 16. Moreover, foster care placement was associated with the developmental trajectory of mediofrontal theta across the adolescent period (ages 12-16), which was, in turn, associated with greater reductions in transdiagnostic risk across this same period. These data reflect the first experimental evidence that the development of mediofrontal theta is impacted by removal from situations of neglect in humans, and further characterizes the importance of studying developmental change in mediofrontal theta during the adolescent period.",2020,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.",['136 children reared in Romanian institutions'],['high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group'],"['Adolescent cognitive control and mediofrontal theta oscillations', 'transdiagnostic risk', 'mediofrontal activity']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",136.0,0.0417503,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Buzzell', 'Affiliation': 'University of Maryland, College Park, MD, United States. Electronic address: gbuzzell@umd.edu.'}, {'ForeName': 'Sonya V', 'Initials': 'SV', 'LastName': 'Troller-Renfree', 'Affiliation': 'Teachers College, Columbia University, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Debnath', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Bowers', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Harvard Medical School, Boston, MA, United States; Boston Children's Hospital, Boston, MA, United States; Harvard Graduate School of Education, Boston, MA, United States.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2020.100777']
109,32282418,"Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis.","BACKGROUND


BUP-XR (RBP-6000 or SUBLOCADE) is the first Food and Drug Administration-approved subcutaneously administered monthly extended-release buprenorphine medication for the treatment of moderate or severe opioid use disorder. The primary objective of this phase III study was to assess the long-term safety, tolerability, and efficacy of BUP-XR.
METHODS


This open-label multicenter study in adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted placebo-controlled, double-blind phase III study (rollover group) and 412 de novo participants not previously treated with BUP-XR. Participants received an initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses. By study end, participants received up to 12 injections.
RESULTS


Overall, 66.8% of participants reported more than 1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants) were mostly mild or moderate in severity. There were no clinically meaningful changes in safety assessments. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, was lower in the second 6 months of treatment versus the first 6 months. After 12 months of treatment, 61.5% of the rollover participants and 75.8% of the de novo participants were abstinent. Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.
CONCLUSIONS


This study demonstrates that the clinical benefits and acceptable safety profile of BUP-XR demonstrated in the 6-month double-blind study are sustained over a 12-month open-label study, with lower incidence of TEAEs in the second 6 months of treatment.",2020,"Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.
",['adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted'],"['buprenorphine medication', 'BUP-XR', 'initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses', 'placebo', 'Buprenorphine Depot Injection']","['12-Month Safety, Tolerability, and Efficacy Analysis', 'Retention rates', 'long-term safety, tolerability, and efficacy', '1 treatment-emergent adverse event (TEAE']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0673076', 'cui_str': 'XR 300'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",257.0,0.143303,"Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.
","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Andorn', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Barbara R', 'Initials': 'BR', 'LastName': 'Haight', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Shinde', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Fudala', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Heidbreder', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Learned', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Norma Lynn', 'Initials': 'NL', 'LastName': 'Fox', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'Vijay R', 'Initials': 'VR', 'LastName': 'Nadipelli', 'Affiliation': 'From Indivior Inc., North Chesterfield, VA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hassman', 'Affiliation': 'Comprehensive Clinical Research, Berlin, NJ.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rutrick', 'Affiliation': 'Adams Clinical, Watertown, MA.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001195']
110,30368651,"A Qualitative Exploration of Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya.","Detection and treatment of human papillomavirus (HPV) and cervical precancer through screening programs is an effective way to reduce cervical cancer deaths. However, high cervical cancer mortality persists in low- and middle-income countries. As screening programs become more widely available, it is essential to understand how knowledge about cervical cancer and perceived disease risk impacts screening uptake and acceptability. We evaluated women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya, as part of a cluster randomized controlled trial of cervical cancer screening implementation strategies. The educational modules employed simple language and images and sought to increase understanding of the relationship between HPV and cervical cancer, the mechanisms of self-collected HPV testing, and the importance of cervical cancer screening. Modules took place in three different contexts throughout the study: (1) during community mobilization; (2) prior to screening in either community health campaigns or health facilities; and (3) prior to treatment. Between January and September 2016, we conducted in-depth interviews with 525 participants to assess their experience with various aspects of the screening program. After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma. Some misconceptions about cervical cancer were evident. With effective and context-specific training, lay health workers, such as CHVs, can help bridge the gap between cervical cancer screening uptake and acceptability.",2020,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[""women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya"", ""Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya"", '525 participants to assess their experience with various aspects of the screening program']",[],"['awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma', 'cervical cancer mortality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0196419,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[{'ForeName': 'Yujung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA. yujung.choi@duke.edu.'}, {'ForeName': 'Sandra Y', 'Initials': 'SY', 'LastName': 'Oketch', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Konyin', 'Initials': 'K', 'LastName': 'Adewumi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Huchko', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1437-2']
111,31838028,The level of natural autoantibodies to IFN-gamma in varicella infection treated with antiviral drug Anaferon for children: A pilot study.,"Natural circulating antibodies (NAbs) to endogenous regulators have shown to be potential biomarkers in medicine. Due to the lack of reliable assays, only few of them have been well studied. To employ NAbs as biomarkers, an evaluation of changes over the course of a treatment is required. This paper describes our work to analyze the dynamics of NAbs titer to interferon-gamma (IFN-γ) among healthy children of different age and in patients with varicella infection receiving an antiviral drug Anaferon for children (AC, the API are highly diluted antibodies to IFN-γ) in comparison with placebo, and to correlate the findings with the treatment results. IFN-γ plays an essential role during varicella infection, and this fact causes the consequent increase of NAbs to IFN-γ level. The mean anti-IFN-γ NAbs level in the healthy volunteer group was 101 × 10 3  U/ml (age: 0-15 years), which was significantly lower than the mean pre-treatment value in patients with varicella infection 167 × 10 3  U/ml (age: 3-17 years). In the AC group, the NAbs level observed on days 5 and 10 decreased significantly to a level of 154 × 10 3  U/ml, whereas in the placebo group it continued to rise in a time-dependent manner reaching 229 × 10 3  U/ml on day 10. Our findings suggest that treatment with AC is characterized by ""normalization"" of the anti-IFN-γ NAbs levels in patients with varicella infection.",2020,"The mean anti-IFN-γ NAbs level in the healthy volunteer group was 101 × 10 3  U/ml (age: 0-15 years), which was significantly lower than the mean pre-treatment value in patients with varicella infection 167 × 10","['patients with varicella infection', 'healthy children of different age and in patients with varicella infection receiving an antiviral drug Anaferon for children (AC, the API', 'patients with varicella infection 167\u2009×\u200910', 'Children']","['interferon-gamma (IFN-γ', 'antiviral drug Anaferon', 'placebo']","['NAbs level', 'mean anti-IFN-γ NAbs level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008049', 'cui_str': 'Varicella'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C2932403', 'cui_str': 'anaferon'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0390024', 'cui_str': 'API0134'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}]","[{'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C2932403', 'cui_str': 'anaferon'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0399778,"The mean anti-IFN-γ NAbs level in the healthy volunteer group was 101 × 10 3  U/ml (age: 0-15 years), which was significantly lower than the mean pre-treatment value in patients with varicella infection 167 × 10","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Don', 'Affiliation': 'Federal State Budgetary Scientific Institute of General Pathology and Pathophysiology, 125315, Moscow, Russia; OOO «NPF «Materia Medica Holding», 129272, Moscow, Russia. Electronic address: donnelenas@gmail.com.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'van der Meide', 'Affiliation': 'U-CyTech Biosciences, 3584 CM, Utrecht, the Netherlands.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Egorov', 'Affiliation': 'Bashkir State Medical University 450000, Ufa, Bashkortostan Republic, Russia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Putilovskiy', 'Affiliation': 'OOO «NPF «Materia Medica Holding», 129272, Moscow, Russia.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tarasov', 'Affiliation': 'Federal State Budgetary Scientific Institute of General Pathology and Pathophysiology, 125315, Moscow, Russia; OOO «NPF «Materia Medica Holding», 129272, Moscow, Russia.'}]",Immunology letters,['10.1016/j.imlet.2019.10.015']
112,32394874,Combination Therapy Against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (Fungisome TM ) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy.,"Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe, and is a major public health problem in the Indian subcontinent. Miltefosine received approval in 2002 to treat VL in India, and the Indian National Vector Borne Disease Control Programme later adopted a single dose (10 mg/kg) of liposomal amphotericin B. We report results of a randomized trial comparing the efficacy of combination therapy with an Indian preparation of liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine (2.5 mg/kg/day for 14 days;  n  = 66) in comparison to miltefosine monotherapy (2.5 mg/kg/day for 28 days;  n  = 78). Nine patients in the miltefosine group and three in the combination therapy group had to discontinue therapy because of serious adverse events. At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups. By per-protocol analysis, by 6 months after completion of treatment, 12 of 69 patients in the miltefosine monotherapy arm (17.4%, 95% CI: 10.24-28%) and none in the combination therapy arm had relapse. Over 5 years of follow-up, 10 patients in the miltefosine monotherapy arm (all within 0.5-2 years after completing therapy) and none in the combination therapy arm experienced post-kala-azar dermal leishmaniasis. Combination therapy offered benefits over miltefosine monotherapy for VL in India.",2020,"At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups.","['Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe']","['Miltefosine', 'miltefosine', 'liposomal amphotericin', 'miltefosine monotherapy', 'liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine', 'Liposomal Amphotericin B (Fungisome TM ) and Short-Course Miltefosine']","['relapse', 'discontinue therapy because of serious adverse events', 'clinical and parasitological cure rate']","[{'cui': 'C0023290', 'cui_str': 'Visceral leishmaniasis'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0037724', 'cui_str': 'Southern Europe'}]","[{'cui': 'C0068006', 'cui_str': 'miltefosine'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}]",,0.0417871,"At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups.","[{'ForeName': 'Rama Prosad', 'Initials': 'RP', 'LastName': 'Goswami', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Mehebubar', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Sukhen', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Santanu Kumar', 'Initials': 'SK', 'LastName': 'Tripathi', 'Affiliation': 'Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Rudra Prosad', 'Initials': 'RP', 'LastName': 'Goswami', 'Affiliation': 'Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0931']
113,32399632,Ecological momentary assessment of temptations and lapses in non-daily smokers.,"RATIONALE


Little is known about relapse among non-daily, intermittent smokers (ITS), who have difficulty quitting, despite a lack of dependence.
OBJECTIVES


To analyze situations associated with temptations to smoke and smoking lapses among ITS trying to maintain abstinence.
METHODS


Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study. EMA data captured participants' situations and states in temptations (n = 976), including those that eventuated in lapses (n = 147), for up to 6 weeks. Randomly timed assessments assessed background states (n = 11,446). Participants also reported coping performed to prevent lapses. Multilevel analyses compared temptations to background situations, and lapse episodes to resolved temptations.
RESULTS


Temptations were marked by exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption, as well as more negative affect. Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods. Both behavioral and cognitive coping responses were associated with avoiding lapsing, but behavioral coping had much larger effects. The effects of affective distress on lapse risk were mediated by its effects on coping.
CONCLUSIONS


Smoking cues play a major role in ITS' temptations and lapses, perhaps indicating a degree of behavioral dependence. Affective distress also played a role in ITS lapses, undermining the idea that the affective distress seen in daily smokers' lapses is due to nicotine withdrawal. The data reinforce the important role of coping in preventing lapses.",2020,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","['non-daily smokers', 'Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study']",[],"['Affective distress', 'exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption', 'smoking cues and availability of cigarettes, alcohol consumption']","[{'cui': 'C1880200', 'cui_str': 'Occasional tobacco smoker'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",130.0,0.0228674,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA. shiffman@pitt.edu.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health & Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05539-3']
114,32335402,Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.,"BACKGROUND


Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest.
OBJECTIVES


Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up.
METHODS


In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL [""low T""] vs. ≥300 ng/dL [""normal T""]) on rates of pre-specified CV outcomes, using Cox proportional hazards models.
RESULTS


Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
CONCLUSIONS


In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke.
CONDENSED ABSTRACT


In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The ""low T"" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.",2020,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","['2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline', '2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean', 'androgen-deficient men with atherosclerotic cardiovascular disease', 'male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to']",['niacin or placebo plus simvastatin'],"['low baseline testosterone concentrations and increased risk of subsequent CV events', 'CHD death, MI, and stroke composite endpoint', 'Testosterone concentrations and risk of cardiovascular events', 'coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization', 'secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke', 'low baseline testosterone (T) concentrations and subsequent CV outcomes', 'rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007794', 'cui_str': 'Cerebral revascularisation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}]",2118.0,0.309705,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA. Electronic address: william.boden@va.gov.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Miller', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'McGovern', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta.'}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Kashyap', 'Affiliation': 'Long Beach VA Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle, WA.'}]",American heart journal,['10.1016/j.ahj.2020.03.016']
115,32272256,"No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.","The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303.",2020,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","['200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration', 'patients undergoing first isolated']","['saphenous vein grafts', 'coronary computed tomography angiography', 'nonemergent coronary artery bypass grafting (CABG', 'saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique', 'no-touch or conventional open skeletonized vein harvesting technique', 'coronary artery surgery (SWEDEGRAFT']","['patency of coronary artery bypass grafts', 'wound healing in the vein graft sites and the composite outcome of major adverse cardiac events', 'proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0398206', 'cui_str': 'Harvesting of vein'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",200.0,0.0320323,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","[{'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Ragnarsson', 'Affiliation': 'Skane University Hospital and Lund University, Lund, Sweden. Electronic address: sigurdur.ragnarsson@med.lu.se.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Janiec', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Dreifaldt', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ericsson', 'Affiliation': 'Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Holmgren', 'Affiliation': 'University Hospital of Umea, Umea, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hultkvist', 'Affiliation': 'Linkoping University Hospital, Linkoping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Sartipy', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ternström', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Per Vikholm', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Domingos', 'Initials': 'D', 'LastName': 'de Souza', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thelin', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}]",American heart journal,['10.1016/j.ahj.2020.03.009']
116,32304828,"IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods.","BACKGROUND


African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS.
METHODS


This is a mixed-methods study that includes a randomized-controlled trial, ""IMPROVE"", to evaluate a group-based exercise intervention compared to a support group program in older BCS, followed by post-intervention semi-structured interviews to evaluate the intervention. The trial aims to recruit 220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged). Participants are ≥65 years old and within five years of treatment completion for stage I-III breast cancer. Participants are randomized to a 52-week, three sessions/week, one-hour/session, moderate intensity aerobic and resistance group exercise intervention, (n = 110) or a 52-week, one hour/week, support group intervention [attention-control arm], (n = 110). The first 20 weeks of both programs are supervised and the last 32 weeks, unsupervised. The primary outcome is the change in Short Physical Performance Battery (SPPB) Scores at 20 weeks from baseline, between the two arms. Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
DISCUSSION


Results of the trial may contribute to a better understanding of factors associated with recruitment, and acceptability, and will inform future exercise programs to optimally improve health outcomes for older BCS.",2020,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
","['older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds', '220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged', 'African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS', 'Participants are ≥65\u202fyears old and within five years of treatment completion for stage I-III breast cancer']","['moderate intensity aerobic and resistance group exercise intervention', 'exercise intervention', 'community-based exercise intervention']","['functional and health outcomes', 'change in Short Physical Performance Battery (SPPB) Scores', 'change in SPPB scores at 52\u202fweeks, change in body composition and biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",220.0,0.0741916,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Owusu', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America; Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America. Electronic address: Cynthia.owusu@case.edu.'}, {'ForeName': 'Nora L', 'Initials': 'NL', 'LastName': 'Nock', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hergenroeder', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, MetroHealth Medical Center, Cleveland, OH, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Austin', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bennet', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cerne', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': 'Cleveland Clinic, Department of Hematology/Oncology, Cleveland, OH, United States of America.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Petkac', 'Affiliation': 'University Hospitals of Cleveland, Cleveland, OH, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schluchter', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Penn State University College of Medicine, Hershey, PA, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Webb Hooper', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'California Baptist University, Riverside, CA, United States of America.'}, {'ForeName': 'Oghenerukeme', 'Initials': 'O', 'LastName': 'Asagba', 'Affiliation': 'West Virginia University School of Medicine, Morgantown, WV, United States of America.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Wimbley', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Berger', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106001']
117,32338756,Dietary Intake and Biomarkers of Folate and Cobalamin Status in Norwegian Preschool Children: The FINS-KIDS Study.,"BACKGROUND


Folate and cobalamin (vitamin B-12) are essential for growth and development. However, few population-based studies have investigated B-vitamin status in children.
OBJECTIVES


This study aimed to assess biomarkers of folate and vitamin B-12 status and to explore their dietary determinants in healthy Norwegian children.
METHODS


Using baseline data obtained from a randomized controlled trial on the effect of fish intake on neurodevelopment in children aged 4-6 y, we measured the plasma concentrations of folate, cobalamin, total plasma homocysteine (tHcy), and methylmalonic acid (MMA). Food-frequency questionnaires (FFQs) were used to assess dietary intake. We used unadjusted and multiple linear regression models to explore the determinants of biomarker concentrations.
RESULTS


The median (IQR) of plasma folate (n = 197) and plasma cobalamin (n = 195) concentrations were 15.2 (12.2-21.1) nmol/L and 785 (632-905) pmol/L, respectively. Plasma folate concentrations of <10 nmol/L were observed in 13% of the children. No child had a cobalamin concentration <148 pmol/L. Two children were identified with elevated plasma MMA concentrations (>0.26 μmol/L) and 8 children had elevated tHcy concentrations (>6.5 μmol/L). Plasma folate concentration was inversely correlated with tHcy (ρ = -0.24, P < 0.001); we found no correlation between tHcy and cobalamin (ρ = -0.075, P = 0.30). Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not. Consumption of red meat for dinner more than twice a week was associated with 23% lower plasma folate (P < 0.01). No other significant associations between dietary intake and the biomarkers were observed.
CONCLUSIONS


The Norwegian preschool children from this cohort had adequate vitamin B-12 status. Poor folate status was common and associated with elevated tHcy. The implications of poor folate status during childhood should be a prioritized research question. This trial was registered at ClinicalTrials.gov as NCT02331667.",2020,Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not.,"['Norwegian preschool children', 'healthy Norwegian children', 'Norwegian Preschool Children', 'children aged 4-6 y']","['vitamin supplements', 'Folate and cobalamin (vitamin B-12']","['Plasma folate concentrations', 'Consumption of red meat', 'plasma folate concentrations', 'Plasma folate concentration', 'Poor folate status', 'Food-frequency questionnaires (FFQs', 'median (IQR) of plasma folate', 'plasma folate', 'Dietary Intake and Biomarkers of Folate and Cobalamin Status', 'cobalamin concentration', 'elevated tHcy concentrations', 'elevated plasma MMA concentrations', 'plasma concentrations of folate, cobalamin, total plasma homocysteine (tHcy), and methylmalonic acid (MMA']","[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0452848', 'cui_str': 'Red meat'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}]",2.0,0.0824589,Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not.,"[{'ForeName': 'Beate S', 'Initials': 'BS', 'LastName': 'Solvik', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Center for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Center, Bergen, Norway.'}, {'ForeName': 'Maria W', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Jannike', 'Initials': 'J', 'LastName': 'Øyen', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}]",The Journal of nutrition,['10.1093/jn/nxaa111']
118,31412242,Nicotinamide Riboside Augments the Aged Human Skeletal Muscle NAD +  Metabolome and Induces Transcriptomic and Anti-inflammatory Signatures.,"Nicotinamide adenine dinucleotide (NAD + ) is modulated by conditions of metabolic stress and has been reported to decline with aging in preclinical models, but human data are sparse. Nicotinamide riboside (NR) supplementation ameliorates metabolic dysfunction in rodents. We aimed to establish whether oral NR supplementation in aged participants can increase the skeletal muscle NAD +  metabolome and if it can alter muscle mitochondrial bioenergetics. We supplemented 12 aged men with 1 g NR per day for 21 days in a placebo-controlled, randomized, double-blind, crossover trial. Targeted metabolomics showed that NR elevated the muscle NAD +  metabolome, evident by increased nicotinic acid adenine dinucleotide and nicotinamide clearance products. Muscle RNA sequencing revealed NR-mediated downregulation of energy metabolism and mitochondria pathways, without altering mitochondrial bioenergetics. NR also depressed levels of circulating inflammatory cytokines. Our data establish that oral NR is available to aged human muscle and identify anti-inflammatory effects of NR.",2019,"Targeted metabolomics showed that NR elevated the muscle NAD +  metabolome, evident by increased nicotinic acid adenine dinucleotide and nicotinamide clearance products.","['12 aged men with 1\xa0g NR per day for 21\xa0days in a', 'aged participants', 'rodents']","['Nicotinamide riboside (NR) supplementation', 'placebo', 'oral NR supplementation', 'Nicotinamide adenine dinucleotide (NAD + ']",['circulating inflammatory cytokines'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0035804', 'cui_str': 'Rodentias'}]","[{'cui': 'C0068711', 'cui_str': 'pyridinium, 3-(aminocarbonyl)-1-beta-D-ribofuranosyl-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",12.0,0.151196,"Targeted metabolomics showed that NR elevated the muscle NAD +  metabolome, evident by increased nicotinic acid adenine dinucleotide and nicotinamide clearance products.","[{'ForeName': 'Yasir S', 'Initials': 'YS', 'LastName': 'Elhassan', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK; Centre for Endocrinology, Diabetes and Metabolism, Birmingham Health Partners, Birmingham, UK; MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Kluckova', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Fletcher', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Schmidt', 'Affiliation': 'Department of Biochemistry, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Garten', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Doig', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Cartwright', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Oakey', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Claire V', 'Initials': 'CV', 'LastName': 'Burley', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK; Centre for Human Brain Health, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ned', 'Initials': 'N', 'LastName': 'Jenkinson', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK; Centre for Human Brain Health, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Centre for Human Brain Health, University of Birmingham, Birmingham, UK; School of Psychology, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK; Centre for Human Brain Health, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ildem', 'Initials': 'I', 'LastName': 'Akerman', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Seabright', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yu-Chiang', 'Initials': 'YC', 'LastName': 'Lai', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Tennant', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Institute of Translational Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Konstantinos N', 'Initials': 'KN', 'LastName': 'Manolopoulos', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK; Centre for Endocrinology, Diabetes and Metabolism, Birmingham Health Partners, Birmingham, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Brenner', 'Affiliation': 'Department of Biochemistry, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Philp', 'Affiliation': ""School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK; Diabetes and Metabolism Division, Garvan Institute of Medical Research, Sydney, NSW, Australia; Faculty of Medicine, St. Vincent's Clinical School, Sydney, UNSW, Australia.""}, {'ForeName': 'Gareth G', 'Initials': 'GG', 'LastName': 'Lavery', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK; Centre for Endocrinology, Diabetes and Metabolism, Birmingham Health Partners, Birmingham, UK; MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK. Electronic address: g.g.lavery@bham.ac.uk.'}]",Cell reports,['10.1016/j.celrep.2019.07.043']
119,31769212,"Maintenance of Efficacy and Safety of Ustekinumab Through One Year in a Phase II Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Patients With Active Systemic Lupus Erythematosus.","OBJECTIVE


To evaluate the efficacy and safety of ustekinumab through 1 year in a phase II trial in patients with systemic lupus erythematosus (SLE).
METHODS


Eligible patients were diagnosed as having clinically active SLE (based on Systemic Lupus International Collaborating Clinics criteria), despite standard background therapy. Active disease was defined by an SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥6 as well as having ≥1 British Isles Lupus Assessment Group (BILAG) A organ domain score and/or ≥2 BILAG B organ domain scores present at screening. Patients (n = 102) were randomized (3:2) to receive either ustekinumab (~6 mg/kg of single intravenous infusion at week 0, then 90-mg subcutaneous injections every 8 weeks beginning at week 8) or a matching placebo added to standard therapy. At week 24, the placebo group crossed over to receive a subcutaneous 90-mg dose of ustekinumab every 8 weeks, and the original ustekinumab group continued to receive therapy through week 40. Maintenance of efficacy was assessed using the SLEDAI-2K, the SLE Responder Index 4 (SRI-4), physician global assessment, and mucocutaneous and joint disease measures in a modified intent-to-treat population.
RESULTS


SRI-4 response rates were significantly greater in the ustekinumab group (62%) versus the placebo group (33%) in the week 24 primary end point analysis (P = 0.006) and were maintained at week 48 (63.3%) in the ustekinumab group. In the ustekinumab group, response rates across other disease measures were also maintained through week 48. Among patients in the placebo group who crossed over to ustekinumab treatment (n = 33), increased response rates across efficacy measures were noted. Among all ustekinumab-treated patients, 81.7% had ≥1 adverse event (AE), and 15.1% had ≥1 serious AE through week 56. No deaths, malignancies, opportunistic infections, or tuberculosis cases were observed.
CONCLUSION


Ustekinumab provided sustained clinical benefit in patients with SLE through 1 year, with a safety profile consistent with other indications.",2020,"RESULTS


SRI-4 response rate was significantly greater (p=0.006) in the ustekinumab group (62%) vs placebo (33%) in the week 24 primary endpoint analysis and maintained at week 48 (63.3%) in the ustekinumab group.","['patients with active systemic lupus erythematosus', 'Patients (n=102', 'Eligible patients had clinically active SLE (SLE International Collaborating Clinics criteria) despite standard background therapy']","['placebo', 'ustekinumab']","['response rates across efficacy measures', ""SLEDAI-2K, SLE Responder Index 4 (SRI-4), Physician's Global Assessment, and mucocutaneous and joint disease measures"", 'efficacy and safety', 'SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥6 and ≥1 British Isles Lupus Assessment Group (BILAG', 'SRI-4 response rate', 'response rates', 'No deaths, malignancies, opportunistic infections, or tuberculosis cases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",,0.480577,"RESULTS


SRI-4 response rate was significantly greater (p=0.006) in the ustekinumab group (62%) vs placebo (33%) in the week 24 primary endpoint analysis and maintained at week 48 (63.3%) in the ustekinumab group.","[{'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bevra H', 'Initials': 'BH', 'LastName': 'Hahn', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Tsokos', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lipsky', 'Affiliation': 'AMPEL BioSolutions, LLC, Charlottesville, Virginia.'}, {'ForeName': 'Kaiyin', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Gordon', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gregan', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Chevrier', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41179']
120,31899372,Design and sample characteristics of COordinated Oral health Promotion (CO-OP) Chicago: A cluster-randomized controlled trial.,"COordinated Oral health Promotion (CO-OP) Chicago is a two-arm cluster-randomized trial with a wait-list control. The primary aim is to evaluate the efficacy of an oral health community health worker (CHW) intervention to improve oral health behaviors in low-income, urban children under the age of three years. Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting. This paper describes progress toward achieving these aims. Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois. Sites were cluster-randomized to CHW intervention or usual services (a wait-list control). The intervention is oral health support from CHWs delivered in four visits to individual families over one year. The trial sample consists of 420 child/caregiver dyads enrolled at the 20 participating sites over 11 months. Participant demographics varied across the sites, but primary outcomes values at baseline did not. Data on brushing frequency, plaque, and other oral health behaviors are collected at three timepoints: baseline, 6-, and 12-months. The primary analysis will assess differences in caregiver-reported child brushing frequency and observed plaque score between the two arms at 12-months. The trial is currently in the active intervention phase. The trial's cluster-randomized controlled design takes a real-world approach by integrating into existing health and social service agencies and collecting data in participant homes. Results will address an important child health disparity. ClinicalTrials.gov identifier: NCT03397589. CLINICAL TRIAL REGISTRATION: University of Illinois at Chicago Protocol Record 2017-1090. National Institutes of Dental & Craniofacial Research of the National Institutes of Health (NIDCR) Protocol Number: 17-074-E. NCT03397589.",2020,"Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting.","['National Institutes of Dental & Craniofacial Research of the National Institutes of Health', 'low-income, urban children under the age of three years', '420 child/caregiver dyads enrolled at the 20 participating sites over 11\u202fmonths', 'participant homes', 'University of Illinois at Chicago Protocol Record 2017-1090', 'Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois']","['COordinated Oral health Promotion (CO-OP', 'oral health community health worker (CHW) intervention', 'CHW intervention or usual services (a wait-list control']","['caregiver-reported child brushing frequency and observed plaque score', 'brushing frequency, plaque, and other oral health behaviors', 'oral health behaviors']","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0035168'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}]","[{'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion (regime/therapy)'}, {'cui': 'C0029162'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0029162'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.126316,"Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting.","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Martin', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States; University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States. Electronic address: mollyma@uic.edu.'}, {'ForeName': 'Lacey J', 'Initials': 'LJ', 'LastName': 'Zimmerman', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States.'}, {'ForeName': 'Genesis F', 'Initials': 'GF', 'LastName': 'Rosales', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Helen H', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States; University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Nattanit', 'Initials': 'N', 'LastName': 'Songthangtham', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Pugach', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Sandoval', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Avenetti', 'Affiliation': 'University of Illinois at Chicago, College of Dentistry, 801 S Paulina St, Chicago, IL 60612, United States.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Alvarez', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Gansky', 'Affiliation': 'University of California, Box# 1361, San Francisco, CA 94143, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105919']
121,31729566,Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial.,"We undertook a cost-effectiveness analysis (CEA) to compare an exercise and nutritional program with the usual nutritional care concomitant to adjuvant chemotherapy in localized breast cancer patients. The CEA was designed as part of the interventional, controlled, randomized, single-center, open-label PASAPAS study. Breast cancer patients receiving first-line adjuvant chemotherapy at a French Comprehensive Cancer Center were randomized 2:1 to a 6-month exercise program of supervised indoor and outdoor group sessions in addition to usual nutritional care (exercise arm) or a usual nutritional care group receiving dietary and physical activity counseling (control arm). Costs were assessed from the French national insurance perspective (in Euros, 2012). Incremental cost-effectiveness ratios (ICERs) were calculated for four criteria: body mass index, waist circumference, body fat percentage, and estimated aerobic capacity. Uncertainty around the ICERs was captured by a probabilistic analysis using a non-parametric bootstrap method. The analysis was based on 60 patients enrolled between 2011 and 2013. Average intervention costs per participant were €412 in the exercise arm (n = 41) and €117 (n = 19) in the control arm. Total mean costs were €17,344 (standard deviation 9,928) and €20,615 (standard deviation 14,904), respectively, did not differ significantly (p = 0.51). The 6-month exercise program was deemed to be cost-effective compared with usual care for the estimated aerobic capacity. Multicenter randomized studies with long-term costs and outcomes should be done to provide additional evidence. Clinical trial: The PASAPAS study is registered under ClinicalTrials.gov. Trial registration ID: NCT01331772.",2020,"Total mean costs were €17,344 (standard deviation 9,928) and €20,615 (standard deviation 14,904), respectively, did not differ significantly (p = 0.51).","['localized breast cancer', 'localized breast cancer patients', 'Breast cancer patients receiving first-line adjuvant chemotherapy at a French Comprehensive Cancer Center', '60 patients enrolled between 2011 and 2013']","['exercise program of supervised indoor and outdoor group sessions in addition to usual nutritional care (exercise arm) or a usual nutritional care group receiving dietary and physical activity counseling (control arm', 'exercise and nutritional intervention versus usual nutritional care', 'exercise and nutritional program with the usual nutritional care concomitant to adjuvant chemotherapy']","['Cost-effectiveness', 'Incremental cost-effectiveness ratios (ICERs', 'Total mean costs']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.104447,"Total mean costs were €17,344 (standard deviation 9,928) and €20,615 (standard deviation 14,904), respectively, did not differ significantly (p = 0.51).","[{'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Perrier', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France. lionel.perrier@lyon.unicancer.fr.'}, {'ForeName': 'Aude-Marie', 'Initials': 'AM', 'LastName': 'Foucaut', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Morelle', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Touillaud', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Kempf-Lépine', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Heinz', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Gomez', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Meyrand', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Baudinet', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Berthouze', 'Affiliation': 'Inter-university Laboratory of Human Movement Biology EA 7424, Univ Lyon, University Claude Bernard Lyon 1, Villeurbanne, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Reynes', 'Affiliation': 'Laboratory of Vulnerabilities and Innovation in Sport EA 7428, FED 4272, Univ Lyon, University Claude Bernard Lyon 1, Villeurbanne, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Carretier', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Guillemaut', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pérol', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Philip', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bachmann', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Fervers', 'Affiliation': 'Léon Bérard Cancer Center, 28 rue Laënnec, 69008, Lyon, France.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05078-4']
122,32393654,Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction.,"OBJECTIVE


To test whether intensive atorvastatin (ATV) increases the efficacy of transplantation with autologous bone marrow mononuclear cells (MNCs) in patients suffering from anterior ST-elevated myocardial infarction (STEMI).
METHODS


This clinical trial was under a 2×2 factorial design, enrolling 100 STEMI patients, randomly into four groups of regular (RA) or intensive ATV (IA) with MNCs or placebo. The primary endpoint was the change of left ventricular ejection fraction (LVEF) at 1-year follow-up from baseline, primarily assessed by MRI. The secondary endpoints included other parameters of cardiac function, remodelling and regeneration determined by MRI, echocardiography, positron emission tomography (PET) and biomarkers.
RESULTS


All the STEMI patients with transplantation of MNCs showed significantly increased LVEF change values than those with placebo (p=0.01) with only in the IA+MNCs patients group demonstrating significantly elevation of LVEF than in the IA+placebo group (+12.6% (95%CI 10.4 to 19.3) vs +5.0% (95%CI 4.0 to 10.0), p=0.001), pointing to a better synergy between ATV and MNCs (p=0.019). PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced. All these above benefits of MNCs were also attributed to IA+MNCs instead of RA+MNCs group of patients with STEMI.
CONCLUSIONS


Intensive ATV treatment augments the therapeutic efficacy of MNCs in patients with anterior STEMI at the convalescent stage. The treatment with the protocol of intensive ATV and MNC combination offers a clinically essential approach for myocardial infarction.
TRIAL REGISTRATION NUMBER


NCT00979758.",2020,"PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced.","['acute myocardial infarction', 'enrolling 100 STEMI patients', 'patients with anterior STEMI at the convalescent stage', 'patients suffering from anterior ST-elevated myocardial infarction (STEMI']","['IA+placebo', 'autologous bone marrow mononuclear cells (MNCs', 'intensive atorvastatin (ATV', 'regular (RA) or intensive ATV (IA) with MNCs or placebo', 'bone marrow mononuclear cells with intensive atorvastatin', 'intensive ATV and MNC combination', 'placebo']","['viable areas of myocardium', 'LVEF change values', 'cardiac function, remodelling and regeneration determined by MRI, echocardiography, positron emission tomography (PET) and biomarkers', 'blood aminoterminal pro-B-type natriuretic peptide', 'elevation of LVEF', 'scar sizes', 'change of left ventricular ejection fraction (LVEF', 'therapeutic efficacy of MNCs']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0210243', 'cui_str': 'atevirdine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0565965', 'cui_str': 'Change values'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}]",100.0,0.276779,"PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced.","[{'ForeName': 'Yue-Jin', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China yangyjfw@126.com.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Geng', 'Affiliation': 'The Center for Cardiovascular Biology and Atherosclerosis, Department of Internal Medicine, University of Texas McGovern School of Medicine at Houston, Houston, Texas, USA.'}, {'ForeName': 'Run-Lin', 'Initials': 'RL', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Center for Cardiac Critical Care, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Xia-Qiu', 'Initials': 'XQ', 'LastName': 'Tian', 'Affiliation': 'Center for Cardiac Critical Care, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Pei-Sen', 'Initials': 'PS', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Nuclear Medicine, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Lu', 'Affiliation': 'Department of Magnetic Resonance Imaging, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shi-Hua', 'Initials': 'SH', 'LastName': 'Zhao', 'Affiliation': 'Department of Magnetic Resonance Imaging, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei-Chun', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Echocardiography, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Open heart,['10.1136/openhrt-2019-001139']
123,32396095,Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games for Children With Hemiplegia: Development and Proof-of-Concept.,"We describe the development and three case reports of a home-based intervention for children with hand hemiplegia that integrates custom video games with contralaterally controlled functional electrical stimulation (CCFES). With CCFES, stimulated opening of the more-affected hand is modulated by volitional opening of the less-affected hand. Video games that solicit goal-oriented, skill-requiring movement have shown promise for treating hemiplegia, but they have not previously been combined with electrical stimulation in children. Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia were assigned six weeks of therapy in lab and at home. The goal was to determine if children could tolerate 9 lab treatment sessions and administer up to 7.5 hrs/wk of CCFES video game therapy at home. The feasibility of this intervention for home use was assessed by device logs, end-of-treatment interviews, and motor function/impairment assessments. With caregiver help, the children were all able to attend 9 lab sessions and built up to 7.5 hrs/wk of therapy by week 3. They averaged 5-7 hrs/wk of home intervention overall. Motor outcomes improved for all three participants at treatment end, but mostly regressed at 4-weeks follow-up. Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2. We found preliminary indications that CCFES-integrated video game therapy can provide a high dose of hand motor control therapy at home and in the lab. Improvements in motor outcomes were also observed, but more development and study is needed.",2020,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","['Children with Hemiplegia', 'Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia', 'children with hand hemiplegia that integrates']","['custom video games with contralaterally controlled functional electrical stimulation (CCFES', 'CCFES-integrated video game therapy', 'home-based intervention', 'CCFES video game therapy', 'Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games']",['Motor outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.063265,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Curby', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Suder', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Katholi', 'Affiliation': ''}, {'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2992036']
124,32333875,"Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial.","BACKGROUND


Given the unique phenotype of type 2 diabetes in Japanese patients, novel therapies such as oral semaglutide require evaluation in this population. PIONEER 9 aimed to assess the dose-response of oral semaglutide and to compare the efficacy and safety of oral semaglutide with placebo and a subcutaneous GLP-1 receptor agonist in a Japanese population.
METHODS


PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan. Japanese patients aged 20 years or older with uncontrolled type 2 diabetes managed by diet or exercise or with oral glucose-lowering drug monotherapy (washed out) were randomly assigned (1:1:1:1:1) to receive double-blind once-daily oral semaglutide (3 mg, 7 mg, or 14 mg) or placebo, or open-label subcutaneous once-daily liraglutide 0·9 mg. The primary endpoint was change in HbA 1c  from baseline to week 26 with the trial product (primary) estimand (which assumes all patients remained on trial product without rescue medication use) in all randomly assigned patients. This trial is registered with ClinicalTrials.gov, NCT03018028.
FINDINGS


Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48). Changes in HbA 1c  from baseline (mean 8·2%) to week 26 were dose-dependent with oral semaglutide (mean change -1·1% [SE 0·1] for oral semaglutide 3 mg, -1·5% [0·1] for 7 mg, and -1·7% [0·1] for 14 mg), -0·1% (0·1) with placebo, and -1·4% (0·1) with liraglutide 0·9 mg. Estimated treatment differences for change in HbA 1c  compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) for oral semaglutide 14 mg. Estimated treatment differences for change in HbA 1c  compared with liraglutide 0·9 mg were 0·3 percentage points (95% CI -0·0 to 0·6; p=0·0799) for oral semaglutide 3 mg, -0·1 percentage points (-0·4 to 0·2; p=0·3942) for oral semaglutide 7 mg, and -0·3 percentage points (-0·6 to -0·0; p=0·0272) for oral semaglutide 14 mg. Gastrointestinal events, predominantly of mild or moderate severity, were the most frequently reported class of adverse event with oral semaglutide: constipation was most common, occurring in five to six (10-13%) patients with oral semaglutide, three (6%) with placebo, and nine (19%) with liraglutide 0·9 mg.
INTERPRETATION


This study showed that oral semaglutide provides significant reductions in HbA 1c  compared with placebo in a dose-dependent manner in Japanese patients with type 2 diabetes, and has a safety profile consistent with that of GLP-1 receptor agonists.
FUNDING


Novo Nordisk.",2020,"Estimated treatment differences for change in HbA 1c  compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) for oral semaglutide 14 mg.","['Japanese patients aged 20 years or older with uncontrolled type 2 diabetes managed by diet or exercise or with oral glucose-lowering drug monotherapy (washed out', 'Japanese patients with type 2 diabetes (PIONEER 9', 'Japanese patients with type 2 diabetes', 'Japanese patients', 'Between Jan 10, and July 11, 2017', '243 patients', '16 sites (clinics and university hospitals) in Japan', 'Japanese population']","['liraglutide', 'oral semaglutide monotherapy', 'placebo, or open-label subcutaneous once-daily liraglutide 0·9 mg', 'oral semaglutide with placebo', 'subcutaneous GLP-1 receptor agonist', 'liraglutide 0·9 mg', 'placebo', 'double-blind once-daily oral semaglutide', 'oral semaglutide']","['efficacy and safety', 'Gastrointestinal events', 'change in HbA 1c', 'Dose-response, efficacy, and safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",243.0,0.144831,"Estimated treatment differences for change in HbA 1c  compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) for oral semaglutide 14 mg.","[{'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Akita, Japan. Electronic address: yamada@gipc.akita-u.ac.jp.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Katagiri', 'Affiliation': 'Department of Metabolism and Diabetes, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Deenadayalan', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Navarria', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Nishijima', 'Affiliation': 'Novo Nordisk Pharma, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30075-9']
125,32333876,"Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial.","BACKGROUND


New glucose-lowering medications need to be investigated in east Asian populations, as the clinical characteristics of type 2 diabetes differ between western and east Asian patients. The PIONEER 10 study aimed to evaluate the safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes.
METHODS


PIONEER 10 was an open-label, randomised, active-controlled, phase 3a trial done at 36 sites (clinics and university hospitals) in Japan. Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication. The primary endpoint was the number of treatment-emergent adverse events over 57 weeks. Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA 1c  and bodyweight at 52 weeks. This trial is registered with ClinicalTrials.gov, NCT03015220.
FINDINGS


Between Jan 10, and May 30, 2017, 492 patients were screened and 458 were randomly assigned to oral semaglutide 3 mg (n=131), 7 mg (n=132), or 14 mg (n=130), or dulaglutide 0·75 mg (n=65). 448 (98%) patients completed the trial. Adverse events occurred in 101 (77%) of 131 patients with oral semaglutide 3 mg, 106 (80%) of 132 with oral semaglutide 7 mg, 111 (85%) of 130 with oral semaglutide 14 mg, and 53 (82%) of 65 with dulaglutide. The most common adverse events were infections and gastrointestinal events. Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide. Adverse events led to premature treatment discontinuation in four (3%) of 131 patients receiving oral semaglutide 3 mg, eight (6%) of 132 receiving oral semaglutide 7 mg, eight (6%) of 130 receiving oral semaglutide 14 mg, and two (3%) of 65 receiving dulaglutide. No deaths or severe hypoglycaemic events were reported. Based on the treatment policy estimand (ie, regardless of study drug discontinuation or rescue medication use), estimated mean reductions in HbA 1c  from baseline (8·3%) to week 52 were -0·9 percentage points (SE 0·1) with oral semaglutide 3 mg, -1·4 percentage points (0·1) with oral semaglutide 7 mg, -1·7 percentage points (0·1) with oral semaglutide 14 mg, and -1·4 percentage points (0·1) with dulaglutide (estimated treatment difference -0·3% [95% CI -0·6 to -0·1] for oral semaglutide 14 mg vs dulaglutide; p=0·0170). Estimated mean changes in bodyweight from baseline (72·1 kg) to week 52 were 0·0 kg (SE 0·3) with oral semaglutide 3 mg, -0·9 kg (0·3) with oral semaglutide 7 mg, -1·6 kg (0·3) with oral semaglutide 14 mg, and 1·0 kg (0·4) with dulaglutide (estimated treatment difference -2·6 kg [95% CI -3·5 to -1·6] for oral semaglutide 14 mg vs dulaglutide; p<0·0001).
INTERPRETATION


Oral semaglutide was well tolerated in Japanese patients with type 2 diabetes. Once-daily oral semaglutide significantly reduced HbA 1c  (14 mg dose) and bodyweight (7 mg and 14 mg doses) versus weekly subcutaneous dulaglutide 0·75 mg by week 52.
FUNDING


Novo Nordisk.",2020,Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide.,"['Japanese patients with type 2 diabetes (PIONEER 10', 'east Asian populations', 'PIONEER 10 was an open-label, randomised, active-controlled, phase 3a trial done at 36 sites (clinics and university hospitals) in Japan', 'Patients aged 20 years and older with uncontrolled type 2 diabetes', 'Japanese patients with type 2 diabetes', 'western and east Asian patients', 'Between Jan 10, and May 30, 2017, 492 patients were screened and 458', '131 patients receiving', '448 (98%) patients completed the trial']","['dulaglutide 0·75 mg', 'oral semaglutide versus dulaglutide', 'subcutaneous dulaglutide', 'oral semaglutide']","['Gastrointestinal adverse events (mostly mild and transient constipation and nausea', 'number of treatment-emergent adverse events', 'Safety and efficacy', 'safety and efficacy', 'deaths or severe hypoglycaemic events', 'Adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",492.0,0.0983515,Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide.,"[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Diabetes and Endocrinology, Gifu University Graduate School of Medicine, Gifu, Japan. Electronic address: ydaisuke-kyoto@umin.ac.jp.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Deenadayalan', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Navarria', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Gislum', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Inagaki', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30074-7']
126,32333877,"Denosumab and cinacalcet for primary hyperparathyroidism (DENOCINA): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Medical treatment options for primary hyperparathyroidism are scarce. We aimed to assess the efficacy of denosumab and combined with cinacalcet in patients with primary hyperparathyroidism.
METHODS


In this randomised, single-centre, proof-of-concept, double-blind trial, patients aged at least 18 years with primary hyperparathyroidism were recruited from the Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark. Key eligibility criteria were a T-score between -1·0 and -3·5 at the lumbar spine, femoral neck, or total hip. Patients were assigned (1:1:1) via permuted block randomisation to receive 30 mg cinacalcet per day plus 60 mg denosumab subcutaneously every 6 months (n=14; combination group) for 1 year, denosumab plus placebo (n=16; denosumab group) for 1 year, or placebo plus placebo injection (n=15; placebo group) for 1 year. Primary outcomes were changes in bone mineral density (BMD) measured by dual x-ray absorptiometry at the lumbar spine, total hip, femoral neck, and distal forearm after 1 year. Additionally, effects on bone-metabolic biochemistry were explored. Patients and investigators were masked. All enrolled patients were included in efficacy analyses. The trial was done in an outpatient setting and is registered at ClinicalTrials.gov, NCT03027557, and has been completed.
FINDINGS


Between March 14, 2017, and March 16, 2018 we recruited 285 participants. 16 patients were randomly allocated to the denosumab group, 15 to the combination group, and 15 to the placebo group. Dropout was limited to one patient in the combination group. Compared with placebo, BMD improved in groups receiving denosumab: lumbar spine (combination group 5·4% [95% CI 2·7-8·1], denosumab group 6·9% [95% CI 4·2-9·6]; p<0·0001), total hip (combination group 5·0% [3·0-6·9], denosumab group 4·1% [2·5-5·8]; p<0·0001), and femoral neck (combination group 4·5% [1·9-7·9]; p=0·0008, denosumab group 3·8% [1·4-6·3]; p=0·0022]). Changes in BMD at the third distal forearm were borderline significant. Six non-fatal serious adverse events occurred (combination group [n=2], denosumab group [n=1], placebo group [n=3]). The overall prevalence of adverse events did not differ between treatment groups, and no fatal adverse events occurred.
INTERPRETATION


Evidence suggested denosumab was effective in improving BMD and lowering bone turnover in patients with primary hyperparathyroidism irrespective of cinacalcet treatment and might be a valid option for patients in which surgery is undesirable.
FUNDING


Aalborg University Hospital and Aalborg University, Denmark.",2020,"Compared with placebo, BMD improved in groups receiving denosumab: lumbar spine (combination group 5·4% [95% CI 2·7-8·1], denosumab group 6·9% [95% CI 4·2-9·6]; p<0·0001), total hip (combination group 5·0% [3·0-6·9], denosumab group 4·1% [2·5-5·8]; p<0·0001), and femoral neck (combination group 4·5% [1·9-7·9]; p=0·0008, denosumab group 3·8% [1·4-6·3]; p=0·0022]).","['16 patients', 'Between March 14, 2017, and March 16, 2018', 'patients aged at least 18 years with primary hyperparathyroidism were recruited from the Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark', 'patients with primary hyperparathyroidism', 'we recruited 285 participants']","['denosumab plus placebo', 'denosumab', 'denosumab and combined with cinacalcet', 'placebo', 'placebo plus placebo injection', 'Denosumab and cinacalcet']","['BMD', 'femoral neck', 'fatal adverse events', 'Changes in BMD', 'bone mineral density (BMD) measured by dual x-ray absorptiometry at the lumbar spine, total hip, femoral neck, and distal forearm after 1 year', 'overall prevalence of adverse events', 'bone-metabolic biochemistry', 'total hip', 'Six non-fatal serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221002', 'cui_str': 'Primary hyperparathyroidism'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}]",16.0,0.684571,"Compared with placebo, BMD improved in groups receiving denosumab: lumbar spine (combination group 5·4% [95% CI 2·7-8·1], denosumab group 6·9% [95% CI 4·2-9·6]; p<0·0001), total hip (combination group 5·0% [3·0-6·9], denosumab group 4·1% [2·5-5·8]; p<0·0001), and femoral neck (combination group 4·5% [1·9-7·9]; p=0·0008, denosumab group 3·8% [1·4-6·3]; p=0·0022]).","[{'ForeName': 'Julius Simoni', 'Initials': 'JS', 'LastName': 'Leere', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: j.leere@rn.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Endocrinology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Robaczyk', 'Affiliation': 'Department of Endocrinology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lykkeboe', 'Affiliation': 'Department of Clinical Biochemistry, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Aase', 'Initials': 'A', 'LastName': 'Handberg', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Clinical Biochemistry, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Steinkohl', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Radiology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Brøndum Frøkjær', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Radiology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Endocrinology, Aalborg University, Aalborg, Denmark; Steno Diabetes Center North Jutland, Aalborg, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30063-2']
127,32289741,Dulaglutide reduces binge episodes in type 2 diabetic patients with binge eating disorder: A pilot study.,"AIMS


Binge eating disorder (BED) is the most common eating disorder in the United States and Europe and is associated with obesity and type 2 diabetes (T2D). Presence and severity of BED have been associated with worse metabolic control and greater BMI in T2D patients. Glucagon Like Peptide-1 (GLP1) receptors are present in central nervous system areas involved in appetite regulation and treatment with GLP-1 receptor agonists modulates appetite and reward-related brain areas in humans. We evaluated the effects of treatment with dulaglutide on eating behavior in T2D outpatients with BED.
METHODS


This was a pilot open label, prospective controlled study. Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED. Patients were randomly assigned to receive either Dulaglutide 1,5 mg/sett or Gliclazide 60 mg for 12 weeks. We evaluated baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes after treatment. A multivariate linear regression model was used to verify the association between Δ BES from baseline with Δ Hba1c and variation of anthropometric parameters after treatment.
RESULTS


After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide. Reduction in BES was associated with reduction in body weight (p < 0.0001) and HbA1c (p = 0.033).
CONCLUSION


Dulaglutide treatment reduces binge eating behaviour in T2D patients with BED.",2020,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","['T2D patients', 'type 2 diabetic patients with binge eating disorder', 'T2D outpatients with BED', 'Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED', 'T2D patients with BED']","['Dulaglutide 1,5 mg/sett or Gliclazide', 'Dulaglutide treatment', 'dulaglutide', 'Dulaglutide', 'gliclazide']","['BMI', 'percentage fat mass', 'binge eating behaviour', 'binge episodes', 'baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes', 'Reduction in BES', 'eating behavior', 'body weight']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0375975,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Da Porto', 'Affiliation': 'Internal Medicine, University of Udine, Italy. Electronic address: daporto.andrea@gmail.com.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Casarsa', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Catena', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cavarape', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Sechi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.03.009']
128,32217148,"Oleoylethanolamide supplementation in obese patients newly diagnosed with non-alcoholic fatty liver disease: Effects on metabolic parameters, anthropometric indices, and expression of PPAR-α, UCP1, and UCP2 genes.","The effects of oleoylethanolamide (OEA) on NAFLD are yet to be examined in human. The objective of the present study was to examine the effects of OEA supplementation along with weight loss intervention on the expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices among obese patients with NAFLD. In this triple-blind placebo-controlled randomized clinical trial, 76 obese patients newly diagnosed with NAFLD were randomly allocated into either OEA or placebo group along with calorie-restricted diets for 12 weeks. At pre-and post-intervention phase, mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations were assessed. There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint. A significant decrease in the anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration was also observed in the OEA group, compared to the placebo group. OEA treatment significantly resulted in decreased serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations. Importantly, a significant improvement in TG, ALT, AST, ALT/AST, HDL-C levels as well as appetite sensations by OEA were under the influence of body mass index (BMI). Although liver steatosis severity was significantly reduced in both groups, the between-group differences did not reach statistical significance (P = 0.061). In conclusion, the present study, for the first time, revealed that OEA supplementation significantly improved anthropometric and metabolic risk factors related to NAFLD.",2020,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","['76 obese patients newly diagnosed with NAFLD', 'obese patients newly diagnosed with non-alcoholic fatty liver disease', 'obese patients with NAFLD']","['OEA', 'oleoylethanolamide (OEA', 'Oleoylethanolamide supplementation', 'placebo', 'OEA supplementation', 'OEA or placebo']","['liver steatosis severity', 'mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations', 'serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations', 'expression levels of PPAR-α, UCP1, and UCP2 genes', 'TG, ALT, AST, ALT/AST, HDL-C levels', 'anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration', 'expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices', 'anthropometric and metabolic risk factors']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",76.0,0.0855709,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","[{'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: helda.nutrition@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ostadrahimi@tbzmed.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saghafi-Asl', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Saghafiaslm@gmail.com.'}, {'ForeName': 'Mohammad-Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mhosseinzadeh@tums.ac.ir.'}, {'ForeName': 'Abolhasan', 'Initials': 'A', 'LastName': 'Shakeri', 'Affiliation': 'Department of Radiology, Imam Reza Teaching Hospital, Clinical Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: shakeria@tbzmed.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, School of Health, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: m.asghari862@gmail.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Neda.roshanravan10@gmail.com.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Farrin', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: nazilafarrin@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naemi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Hasankhani', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Pharmacological research,['10.1016/j.phrs.2020.104770']
129,24615500,Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2.,"BACKGROUND


In the BOLERO-2 trial, everolimus (EVE), an inhibitor of mammalian target of rapamycin, demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane (EXE) in postmenopausal women with hormone receptor-positive (HR(+)) advanced breast cancer. We report on the incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs) as well as incidence of dose modifications during the extended follow-up of this study.
PATIENTS AND METHODS


Patients were randomized (2:1) to receive EVE 10 mg/day or placebo (PBO), with open-label EXE 25 mg/day (n = 724). The primary end point was progression-free survival. Secondary end points included overall survival, objective response rate, and safety. Safety evaluations included recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations.
RESULTS


The safety population comprised 720 patients (EVE + EXE, 482; PBO + EXE, 238). The median follow-up was 18 months. Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia, were generally of mild or moderate severity and occurred relatively early after treatment initiation (except pneumonitis); incidence tapered off thereafter. EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age. The median duration of dose interruption was 7 days. Discontinuation of both study drugs because of AEs was higher with EVE + EXE (9%) versus PBO + EXE (3%).
CONCLUSIONS


Most EVE-associated AEs occur soon after initiation of therapy, are typically of mild or moderate severity, and are generally manageable with dose reduction and interruption. Discontinuation due to toxicity was uncommon. Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education.
TRIAL REGISTRATION NUMBER


NCT00863655.",2014,"EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age.","['postmenopausal women with hormone receptor-positive (HR(+)) advanced breast cancer', '720 patients (EVE + EXE, 482; PBO + EXE, 238', 'Patients', 'postmenopausal women with hormone receptor-positive advanced breast cancer']","['EVE + EXE', 'exemestane (EXE', 'everolimus (EVE', 'EVE 10 mg/day or placebo (PBO), with open-label EXE']","['Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia', 'incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs', 'overall survival, objective response rate, and safety', 'progression-free survival', 'recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations', 'median duration of dose interruption']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047006', 'cui_str': '(R,S)-N-ethyl-3,4-methylenedioxyamphetamine'}]","[{'cui': 'C0047006', 'cui_str': '(R,S)-N-ethyl-3,4-methylenedioxyamphetamine'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",724.0,0.267679,"EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age.","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, UCSF, San Francisco, USA. Electronic address: hrugo@medicine.ucsf.edu.'}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Odette Cancer Centre and the University of Toronto, Toronto, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noguchi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka University, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Memorial Cancer Institute, Hollywood, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Geberth', 'Affiliation': 'Praxisklinic am Rosengarten Mannheim, Schwerpunktpraxis für Gynaekologische Onkologie, Mannheim, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Csoszi', 'Affiliation': 'Department of Medical Oncology, Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, Hungary.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chouinard', 'Affiliation': 'Cambridge Memorial Hospital, Cambridge, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Srimuninnimit', 'Affiliation': 'Siriraj Hospital, Mahidol University, Bangkok.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Puttawibul', 'Affiliation': 'Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Eakle', 'Affiliation': 'Florida Cancer Specialists, Ft Myers.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bauly', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El-Hashimy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Taran', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Burris', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu009']
130,24667714,"High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial.","BACKGROUND


To investigate the correlation of TargetPrint with local and central immunohistochemistry/fluorescence in situ hybridization assessment of estrogen (ER), progesterone (PgR), and human epidermal growth factor receptor 2 (HER2) in the first 800 patients enrolled in the MINDACT trial.
PATIENTS AND METHODS


Data from local (N = 800) and central (N = 626) assessments of receptor status were collected and compared with TargetPrint results.
RESULTS


For ER, the positive agreement (the percentage of central pathology positive assessments that were also TargetPrint/local laboratory positive) for TargetPrint in comparison to centralized assessment was 98% with a negative agreement (the percentage of central pathology negative assessments that were also TargetPrint/local laboratory negative) of 96%. For PgR, the positive agreement was 83% with a negative agreement of 92%. For HER2, the positive agreement was 75% with a negative agreement of 99%. Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.
CONCLUSION


TargetPrint and local assessment of ER, PgR, and HER2 show high concordance with central assessment in the first 800 MINDACT patients. However, there are concerns about the higher discordance rates for some local sites. TargetPrint can improve the reliability of hormone receptor and HER2 testing for those centers with a lower rate of concordance with the reference laboratory, with the limitation of a positive agreement of 75% for HER2. TargetPrint consequently has important implications for treatment decisions in clinical practice and is a reliable alternative to local assessment for ER.
CLINICAL TRIALS NUMBER


NCT00433589.",2014,"Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.
","['Data from local (N = 800) and central (N = 626', '800 patients enrolled in the MINDACT trial']",['EORTC'],['reliability of hormone receptor and HER2 testing'],"[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]",800.0,0.0611438,"Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy. Electronic address: giuseppe.viale@ieo.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Slaets', 'Affiliation': 'Department of Statistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Statistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': ""Van't Veer"", 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA; Research and Development, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Piccart-Gebhart', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'de Snoo', 'Affiliation': 'Medical Affairs, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stork-Sloots', 'Affiliation': 'Medical Affairs, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Russo', 'Affiliation': 'Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""Dell'Orto"", 'Affiliation': 'Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van den Akker', 'Affiliation': 'Research and Development, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Glas', 'Affiliation': 'Research and Development, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Cancer Center, Lisbon, Portugal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu026']
131,32332565,"Reply: The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.187489,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery Department of Anesthesiology Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, Mo.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': ''}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
132,31738014,"Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.","OBJECTIVE


Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM.
METHODS


Participants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks.
RESULTS


After 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS.
CONCLUSION


Among women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.",2020,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","['women with FM', 'Women with Fibromyalgia', 'Participants']","['Transcutaneous electrical nerve stimulation (TENS', 'active-TENS', 'placebo-TENS or no-TENS', 'placebo-TENS (n=99) or no-TENS', 'TENS']","['movement-evoked pain and fatigue', 'movement-evoked pain', 'global impression of change', 'movement-evoked pain (primary outcome) and fatigue on an 11-point scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0222045'}]",,0.528626,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","[{'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Dailey', 'Affiliation': 'University of Iowa, Iowa City, and St. Ambrose University, Davenport, Iowa.'}, {'ForeName': 'Carol G T', 'Initials': 'CGT', 'LastName': 'Vance', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ericka N', 'Initials': 'EN', 'LastName': 'Merriwether', 'Affiliation': 'New York University, New York, New York.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Geasland', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chimenti', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Golchha', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'University of Iowa, Iowa City.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41170']
133,32325038,"Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.","BACKGROUND


Cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection continue to rise in the Arabian Peninsula 7 years after it was first described in Saudi Arabia. MERS-CoV poses a significant risk to public health security because of an absence of currently available effective countermeasures. We aimed to assess the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans.
METHODS


This dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial was done at the Centre for Clinical Vaccinology and Tropical Medicine (Oxford, UK) and included healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women). Participants received a single intramuscular injection of ChAdOx1 MERS at three different doses: the low-dose group received 5 × 10 9  viral particles, the intermediate-dose group received 2·5 × 10 10  viral particles, and the high-dose group received 5 × 10 10  viral particles. The primary objective was to assess safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited, unsolicited, and serious adverse events after vaccination. The secondary objective was to assess the cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays after vaccination. Participants were followed up for up to 12 months. This study is registered with ClinicalTrials.gov, NCT03399578.
FINDINGS


Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at 6 months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 10 10  viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed to be not related to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered to be possibly, probably, or definitely related to ChAdOx1 MERS were predominantly mild in nature and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001) Laboratory adverse events considered to be at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
INTERPRETATION


ChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to elicit both humoral and cellular responses against MERS-CoV. The results of this first-in-human clinical trial support clinical development progression into field phase 1b and 2 trials.
FUNDING


UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.",2020,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","['healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women', '24 participants were enrolled: six', 'Between March 14 and Aug 15, 2018', 'humans']","['single intramuscular injection of ChAdOx1 MERS', 'low-dose group received 5\u2008×\u200810 9  viral particles, the intermediate-dose group received 2·5\u2008×\u200810 10  viral particles, and the high-dose group received 5\u2008×\u200810 10  viral particles', 'candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine', 'ChAdOx1 MERS']","['Unsolicited adverse events', 'cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays', 'Safety and immunogenicity', 'safety and tolerability of ChAdOx1 MERS', 'serious adverse events', 'safe and well tolerated', 'safety and immunogenicity', 'Neutralising antibodies against live MERS-CoV', 'T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen', 'occurrence of solicited, unsolicited, and serious adverse events', 'proportion of moderate and severe adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019683', 'cui_str': 'Human immunodeficiency virus antibody'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",24.0,0.0881364,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Ramos', 'Initials': 'FR', 'LastName': 'Lopez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mair', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheridan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Young-Shin', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Jae-Ouk', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Manki', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Datoo', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30160-2']
134,31453958,Cognitive behavior therapy for menopausal symptoms (CBT-Meno): a randomized controlled trial.,"OBJECTIVE


To evaluate the effectiveness of cognitive behavioral therapy for menopausal symptoms (CBT-Meno) compared with a waitlist condition (no active intervention). A randomized controlled trial was conducted with 71 perimenopausal or postmenopausal women who were seeking treatment for menopausal symptoms.
METHODS


Blind assessments were conducted at baseline, 12 weeks postbaseline, and 3 months post-treatment. An intention-to-treat analysis was conducted. CBT-Meno sessions included psychoeducation, and cognitive and behavioral strategies for vasomotor and depressive symptoms, anxiety, sleep difficulties, and sexual concerns. Primary outcomes were scores on the Hot Flash Related Daily Interference Scale (HFRDIS) and Beck Depression Inventory (BDI-II). Secondary outcomes were scores assessing vasomotor and sexual concerns on the Greene Climacteric Scale (GCS-vm, GCS-sex), the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Pittsburgh Sleep Quality Index (PSQI), and the Female Sexual Function Index (FSFI).
RESULTS


There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS; P < 0.001, ηP = 0.21) and ""bothersomeness"" (GCS-vm; P = 0.04, ηP = 0.06), depressive symptoms (BDI-II; P = 0.001, ηP = 0.15), sleep difficulties (PSQI; P = 0.001, ηP = 0.17), and sexual concerns (GCS-sex; P = 0.03, ηP = 0.07). These results were found even when controlling for menopausal staging and medication use. Gains were maintained at 3 months post-treatment.
CONCLUSIONS


CBT-Meno was particularly effective in improving self-reported vasomotor symptoms, depressive symptoms, sleep difficulties, and sexual concerns. Although future studies will be needed to confirm the impact of CBT-Meno on anxiety symptoms, these results suggest that this protocol is effective in targeting commonly reported menopausal symptoms. : Video Summary: Supplemental Digiatl Content 1, http://links.lww.com/MENO/A416.",2019,There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS;,"['71 perimenopausal or postmenopausal women who were seeking treatment for menopausal symptoms', 'menopausal symptoms (CBT-Meno']","['Cognitive behavior therapy', ' Video Summary: Supplemental Digiatl Content 1, http://links.lww.com/MENO/A416', 'cognitive behavioral therapy']","['scores on the Hot Flash Related Daily Interference Scale (HFRDIS) and Beck Depression Inventory (BDI-II', 'vasomotor and depressive symptoms, anxiety, sleep difficulties, and sexual concerns', 'depressive symptoms', 'vasomotor symptoms, depressive symptoms, sleep difficulties, and sexual concerns', 'sleep difficulties', 'vasomotor symptom interference (HFRDIS', 'scores assessing vasomotor and sexual concerns on the Greene Climacteric Scale (GCS-vm, GCS-sex), the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Pittsburgh Sleep Quality Index (PSQI), and the Female Sexual Function Index (FSFI', 'bothersomeness', 'sexual concerns']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0682126,There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS;,"[{'ForeName': 'Sheryl M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Donegan', 'Affiliation': ""Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton, Ontario, Canada.""}, {'ForeName': 'Benicio N', 'Initials': 'BN', 'LastName': 'Frey', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Fedorkow', 'Affiliation': 'Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Key', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Randi E', 'Initials': 'RE', 'LastName': 'McCabe', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001363']
135,31453961,Effects of ospemifene on genitourinary health assessed by prospective vulvar-vestibular photography and vaginal/vulvar health indices.,"OBJECTIVE


To prospectively evaluate the effects of ospemifene on the vulva and vagina in postmenopausal women using vulvar-vestibular photography and direct visual assessments.
METHODS


Postmenopausal women (aged 40-80 years) with moderate to severe vaginal dryness as their most bothersome symptom (MBS) were randomized to daily ospemifene 60 mg or placebo in this 12-week, multicenter, double-blind, phase 3 study. Vulvar-vestibular photographic images were captured at baseline and week 12 and were independently assessed with the Vulvar Imaging Assessment Scale (VIAS). Changes from baseline in Vaginal and Vulvar Health Indices (VHI and VuHI) with ospemifene versus placebo were analyzed at weeks 4, 8, and 12. Correlations between VIAS, VHI, and VuHI, with vaginal dryness severity and the Female Sexual Function Index (FSFI) scores were also assessed.
RESULTS


In all, 631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population. Compared with placebo, ospemifene significantly improved total scores for VIAS (P = 0.0154), VHI (P < 0.0001), and VuHI (P < 0.0001) from baseline to week 12; significant VHI (P < 0.0001) and VuHI (P = 0.002) improvements were observed at week 4. Most VHI and VuHI individual items were significantly better with ospemifene versus placebo at week 12 (P < 0.05). Most correlations between the vulvovaginal assessment total scores versus vaginal dryness severity and FSFI scores were significant (P < 0.05).
CONCLUSION


Improvements observed in vulvovaginal health with ospemifene assessed by prospective vulvar-vestibular photography and other direct visual assessments support its efficacy in addition to the treatment of moderate to severe vaginal dryness due to menopause and the use of photographic and direct visual evaluations in future clinical trials.
VIDEO SUMMARY


Supplemental Digital Content 1, http://links.lww.com/MENO/A415.",2019,"Compared with placebo, ospemifene significantly improved total scores for VIAS","['631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population', 'Postmenopausal women (aged 40-80 years) with moderate to severe vaginal dryness as their most bothersome symptom (MBS', 'postmenopausal women using vulvar-vestibular photography and direct visual assessments']","['daily ospemifene 60\u200amg or placebo', 'placebo', 'ospemifene']","['Vulvar-vestibular photographic images', 'genitourinary health assessed by prospective vulvar-vestibular photography and vaginal/vulvar health indices', 'vulvovaginal health', 'Vaginal and Vulvar Health Indices (VHI and VuHI', 'total scores for VIAS', 'vulvovaginal assessment total scores versus vaginal dryness severity and FSFI scores', 'VIAS, VHI, and VuHI, with vaginal dryness severity and the Female Sexual Function Index (FSFI) scores', 'Vulvar Imaging Assessment Scale (VIAS']","[{'cui': 'C1313616', 'cui_str': 'Ospemifene'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3537521', 'cui_str': 'Ospemifene 60 MG [Osphena]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1313616', 'cui_str': 'Ospemifene'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",631.0,0.0693195,"Compared with placebo, ospemifene significantly improved total scores for VIAS","[{'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Goldstein', 'Affiliation': 'Director, Sexual Medicine, Alvarado Hospital, San Diego, CA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University, School of Medicine, IntimMedicine Specialists, Washington, DC.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida, College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Altomare', 'Affiliation': 'Shionogi Inc, Florham Park, NJ.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Shionogi Inc, Florham Park, NJ.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shionogi Inc, Florham Park, NJ.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Schaffer', 'Affiliation': 'Duchesnay Inc, Quebec, Canada.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Soulban', 'Affiliation': 'Duchesnay Inc, Quebec, Canada.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001350']
136,32330925,Effects of serotonin and dopamine depletion on neural prediction computations during social learning.,"We have previously shown that individuals with high depression scores demonstrate impaired behavioral and neural responses during social learning. Given that depression is associated with altered dopamine (DA) and serotonin (5-HT) functioning, the current study aimed to elucidate the role of these neurotransmitters in the social learning process using a dietary depletion manipulation. In a double-blind design, 70 healthy volunteers were randomly allocated to a 5-HT depletion (N = 24), DA depletion (N = 24), or placebo (N = 22) group. Participants performed a social learning task during fMRI scanning, as part of which they learned associations between name cues and rewarding (happy faces) or aversive (fearful faces) social outcomes. Behaviorally, 5-HT depleted subjects demonstrated impaired social reward learning compared to placebo controls, with a marginal effect in the same direction in the DA depletion group. On the neural level, computational modeling-based fMRI analyses revealed that 5-HT depletion altered social reward prediction signals in the insula, temporal lobe, and prefrontal cortex, while DA depletion affected social reward prediction encoding only in the prefrontal cortex. These results indicate that 5-HT depletion impairs learning from social rewards, on both the behavioral and the neural level, while DA depletion has a less extensive effect. Interestingly, the behavioral and neural responses observed after 5-HT depletion in the current study closely resemble our previous findings in individuals with high depression scores using the same task. It may thus be the case that decreased 5-HT levels contribute to social learning deficits in depression.",2020,"Behaviorally, 5-HT depleted subjects demonstrated impaired social reward learning compared to placebo controls, with a marginal effect in the same direction in the DA depletion group.","['70 healthy volunteers', 'individuals with high depression scores', 'neural prediction computations during social learning']","['5-HT depletion (N\u2009=\u200924), DA depletion (N\u2009=\u200924), or placebo', 'serotonin and dopamine depletion', 'social learning task during fMRI scanning, as part of which they learned associations between name cues and rewarding (happy faces) or aversive (fearful faces) social outcomes']",['social reward learning'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0679082', 'cui_str': 'Social Learning'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0679082', 'cui_str': 'Social Learning'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",70.0,0.0161143,"Behaviorally, 5-HT depleted subjects demonstrated impaired social reward learning compared to placebo controls, with a marginal effect in the same direction in the DA depletion group.","[{'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Frey', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK. c.mccabe@reading.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0678-z']
137,31424460,Temporary Stoppages and Burden of Treatment in Patients With Cancer.,"OBJECTIVES


To examine the effect of burden of treatment and multimorbidity on the relationship between baseline characteristics and oral oncolytic agent (OOA) temporary stoppages.
SAMPLE &AMP; SETTING


272 patients newly prescribed OOAs at six National Cancer Institute-designated comprehensive cancer centers.
METHODS &AMP; VARIABLES


Patients were randomly assigned to an adherence and symptom management group or a usual care/control group. Temporary OOA stoppages, symptom interference, OOA regimen complexity, and multimorbidities were explored. Data were collected at four-week intervals for 12 weeks.
RESULTS


Burden of treatment variables and multimorbidity had no significant effect on OOA temporary stoppages. Women and those prescribed kinase inhibitors were significantly more likely to experience a temporary stoppage.
IMPLICATIONS FOR NURSING


Oncology nurses are in a crucial position to educate patients on self-management of OOAs and symptoms. Nurses should be aware of patients who may be more susceptible to severe symptoms, including those with multimorbidities. Future research is needed to better understand OOA stoppages and factors associated with preventing stoppages.",2019,"RESULTS


Burden of treatment variables and multimorbidity had no significant effect on OOA temporary stoppages.","['AMP', '272 patients newly prescribed OOAs at six National Cancer Institute-designated comprehensive cancer centers', 'Patients With Cancer']",['adherence and symptom management group or a usual care/control group'],"['Temporary OOA stoppages, symptom interference, OOA regimen complexity, and multimorbidities']","[{'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",272.0,0.0547763,"RESULTS


Burden of treatment variables and multimorbidity had no significant effect on OOA temporary stoppages.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vachon', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Given', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Given', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'University of Illinois.'}]",Oncology nursing forum,['10.1188/19.ONF.E135-E144']
138,31912320,Comparison of radial extracorporeal shockwave therapy with ultrasound therapy in patients with lateral epicondylitis.,"PURPOSE


Patients suffering from lateral epicondylitis exhibit diminished mobility due to pain. The aim of the study was to compare the efficacy of both shockwave and ultrasound therapies in patients with lateral epicondylitis.
METHODS


The shockwave group consisted of 117 patients, 63 patients constituted the ultrasound group, and 18 patients made up the control group. The ""University of Peloponnese Pain, Functionality and Quality of Life Questionnaire"" was used for the evaluation of pain, functionality, and quality of life on a five-point Likert scale, pre-treatment, post-treatment, and at 4-week follow-up.
RESULTS


The pain was reduced and the functionality and quality of life were improved in both the shockwave and ultrasound groups post-treatment (p < 0.001) and at 4-week follow-up (p < 0.001), but the results in the ultrasound group were not as pronounced as in the shockwave group (p < 0.001).
CONCLUSION


Both radial shockwave and ultrasound therapies were significantly effective in patients with lateral epicondylitis. However, ultrasound therapy was less effective than shockwave therapy.",2020,"The pain was reduced and the functionality and quality of life were improved in both the shockwave and ultrasound groups post-treatment (p < 0.001) and at 4-week follow-up (p < 0.001), but the results in the ultrasound group were not as pronounced as in the shockwave group (p < 0.001).
","['patients with lateral epicondylitis', '117 patients, 63 patients constituted the ultrasound group, and 18 patients made up the control group', 'Patients suffering from lateral epicondylitis exhibit diminished mobility due to pain']","['radial shockwave and ultrasound therapies', 'shockwave therapy', 'shockwave and ultrasound therapies', 'radial extracorporeal shockwave therapy with ultrasound therapy', 'ultrasound therapy']","['pain', 'pain, functionality, and quality of life', 'functionality and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}]",117.0,0.0265122,"The pain was reduced and the functionality and quality of life were improved in both the shockwave and ultrasound groups post-treatment (p < 0.001) and at 4-week follow-up (p < 0.001), but the results in the ultrasound group were not as pronounced as in the shockwave group (p < 0.001).
","[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Dedes', 'Affiliation': 'Laboratory of Physiology-Pharmacology, Department of Nursing, Faculty of Human Movement and Quality of Life Sciences, University of Peloponnese, Efstathiou and Stamatikis Valioti and Plateon, 23 100, Sparta, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tzirogiannis', 'Affiliation': 'Laboratory of Physiology-Pharmacology, Department of Nursing, Faculty of Human Movement and Quality of Life Sciences, University of Peloponnese, Efstathiou and Stamatikis Valioti and Plateon, 23 100, Sparta, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Polikandrioti', 'Affiliation': 'Department of Nursing, Faculty of Health and Caring Professions, University of West Attica, Athens, Greece.'}, {'ForeName': 'Ariadni Maria', 'Initials': 'AM', 'LastName': 'Dede', 'Affiliation': 'Engineering in Biotechnology Department, Absalon University College, Kalundborg, Sjelland, Denmark.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Mitseas', 'Affiliation': 'Orthopaedic Department, Messinion Therapeutirion, Kalamata, Greece.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Panoutsopoulos', 'Affiliation': 'Laboratory of Physiology-Pharmacology, Department of Nursing, Faculty of Human Movement and Quality of Life Sciences, University of Peloponnese, Efstathiou and Stamatikis Valioti and Plateon, 23 100, Sparta, Greece. gpanouts@uop.gr.'}]",Journal of medical ultrasonics (2001),['10.1007/s10396-019-01002-9']
139,32333168,"Light therapy for multiple sclerosis-associated fatigue: a randomized, controlled phase II trial.","BACKGROUND


Bright white light therapy (LT) can improve fatigue in several disease states but has not been studied in multiple sclerosis (MS).
OBJECTIVE


To determine whether controlled home-based LT is feasible, tolerable, and well-adhered to in MS-associated fatigue.
METHODS


A randomized, controlled trial of twice-daily 1-h bright white LT (BWLT) (10,000 lx, active arm) versus dim red LT (DRLT) (< 300 lx, control arm) was performed. Adults with MS-associated fatigue were enrolled for 10 weeks: 2-week baseline, 4-week intervention, 4-week washout.
RESULTS


41 participants were enrolled; 35 were randomized (average age 42 years, 80% female; BWLT n = 20; DRLT n = 15). 31 were in the intention to treat analysis. The average duration of LT sessions was similar between groups (BWLT 60.9 min, DRLT 61.5 min, p = 0.70). The most commonly reported adverse event was headache. There were no events that led to discontinuation. Baseline fatigue was severe in both arms (each 53/63 points on the Fatigue Severity Scale (FSS), p = 0.92). FSS was lower following BWLT (FSS 45.8 post-LT, p = 0.04; 44.9 post-washout, p = 0.02 intra-group compared to baseline FSS) and DRLT (FSS 46.7 post-LT, p = 0.03; 43.9 post-washout, p = 0.002 intragroup compared to baseline FSS). There was no difference between BWLT and DRLT groups in the magnitude of reduction of FSS scores (p = 0.81 after LT; p = 0.77 after washout for between group comparisons). Similarly, MS quality of life metrics improved in both arms but were not significantly different between groups after LT (p = 0.22) or washout.
CONCLUSIONS


LT is safe, feasible, and well-tolerated in people with MS-associated fatigue. Improvement in both light spectra likely indicates a strong placebo effect for the DRLT group.",2020,There was no difference between BWLT and DRLT groups in the magnitude of reduction of FSS scores (p = 0.81 after LT; p = 0.77 after washout for between group comparisons).,"['Adults with MS-associated fatigue', '41 participants were enrolled; 35 were randomized (average age 42\xa0years, 80% female; BWLT n\u2009=\u200920; DRLT n\u2009=\u200915', 'multiple sclerosis-associated fatigue']","['Bright white light therapy (LT', 'twice-daily 1-h bright white LT (BWLT', 'Light therapy', 'dim red LT (DRLT']","['average duration of LT sessions', 'MS quality of life metrics', 'FSS', 'Baseline fatigue', 'Fatigue Severity Scale (FSS', 'FSS scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.137053,There was no difference between BWLT and DRLT groups in the magnitude of reduction of FSS scores (p = 0.81 after LT; p = 0.77 after washout for between group comparisons).,"[{'ForeName': 'Farrah J', 'Initials': 'FJ', 'LastName': 'Mateen', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 165 Cambridge St., Office 627, Boston, MA, 02114, USA. fmateen@mgh.harvard.edu.'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Vogel', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 165 Cambridge St., Office 627, Boston, MA, 02114, USA.'}, {'ForeName': 'Tamara B', 'Initials': 'TB', 'LastName': 'Kaplan', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Gladia C', 'Initials': 'GC', 'LastName': 'Hotan', 'Affiliation': 'Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Grundy', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 165 Cambridge St., Office 627, Boston, MA, 02114, USA.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Holroyd', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 165 Cambridge St., Office 627, Boston, MA, 02114, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Manalo', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 165 Cambridge St., Office 627, Boston, MA, 02114, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stauder', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 165 Cambridge St., Office 627, Boston, MA, 02114, USA.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Videnovic', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 165 Cambridge St., Office 627, Boston, MA, 02114, USA.'}]",Journal of neurology,['10.1007/s00415-020-09845-w']
140,32275033,Comparision of upper thoracic epidural analgesia versus low thoracic epidural analgesia in off-pump coronary artery bypass graft for perioperative pain management and fast tracking.,"Background


Upper thoracic epidural analgesia (TEA) is compared with lower thoracic epidural analgesia for the perioperative pain management and fast tracking in patients undergoing off pump coronary artery bypass grafting (OPCAB) surgery for the intraoperative hemodynamic, quality of analgesia, incentive spirometry, time to awakening & extubation and intensive care unit (ICU) duration.
Materials and Methods


A prospective, randomized comparative clinical study was conducted with total of 60 patients randomized to either Group U: Upper TEA (n = 30) or Group L: Lower TEA (n = 30). Visual analog scale (VAS) was recorded in both the groups during rest and deep breathing at the various time intervals postextubation. Both the groups were also compared for intraoperative hemodynamics, incentive spirometry, time to awakening, and extubation and ICU duration. Statistical analysis was performed using the independent Student's t-test. A value of P < 0.05 was considered statistically significant.
Results


Postextubation VAS score at rest and deep breathing at 0, 3, 6, 12, 24, 36, and 48 h were statistically significant in both groups (P ≤ 0.05). Incentive spirometry, time to awakening and extubation and duration of ICU stay were also statistically significant (P ≤ 0.05) between the groups.
Conclusion


Lower thoracic epidural was better than upper thoracic epidural in perioperative pain management and fast tracking in OPCAB surgery.",2020,"Incentive spirometry, time to awakening and extubation and duration of ICU stay were also statistically significant (P ≤ 0.05) between the groups.
","['patients undergoing off pump coronary artery bypass grafting (OPCAB) surgery', '60 patients randomized to either Group U']","['low thoracic epidural analgesia', 'Upper TEA', '\n\n\nUpper thoracic epidural analgesia (TEA', 'TEA']","['Visual analog scale (VAS', 'intraoperative hemodynamics, incentive spirometry, time to awakening, and extubation and ICU duration', 'Incentive spirometry, time to awakening and extubation and duration of ICU stay', 'Postextubation VAS score at rest and deep breathing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441854', 'cui_str': 'Group U'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}]",60.0,0.0407537,"Incentive spirometry, time to awakening and extubation and duration of ICU stay were also statistically significant (P ≤ 0.05) between the groups.
","[{'ForeName': 'Omshubham Gangadhar', 'Initials': 'OG', 'LastName': 'Asai', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bengaluru, Karnataka, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Prabhakar', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bengaluru, Karnataka, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Manjunatha', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bengaluru, Karnataka, India.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_254_18']
141,32326082,"Mindfulness versus Physical Exercise: Effects of Two Recovery Strategies on Mental Health, Stress and Immunoglobulin A during Lunch Breaks. A Randomized Controlled Trial.","This research analyses the effects of mindfulness meditation (MM) and physical exercise (PE), practised as daily recovery activities during lunch breaks, on perceived stress, general mental health, and immunoglobin A (IgA). A three-armed randomized controlled trial with 94 employees was conducted for five weeks including two follow-up sessions after one and six months. Daily practice lasted 30 min maximum. Perceived stress and general mental health questionnaires and saliva samples were used. There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03,  p  = 0.03], and for MM [Mdiff = 0.09, SE = 0.03,  p  = 0.03]. Moreover, there were significant differences of interaction factor when comparing MM vs. PE in total score at pre-post [F = -2.62 (6, 168.84),  p  = 0.02, ω 2  = 0.09], favoring PE with medium and high effect sizes. Regarding General Health Questionnaire (GHQ) variable, practicing MM showed significant effects in time factor compared to pre-Fup2. No significant differences were found for IgA. Thus, practicing both MM and PE as recovery strategies during lunch breaks could reduce perceived stress after five weeks of practice, with better results for PE. Moreover, practicing MM could improve mental health with effects for 6 months.",2020,"There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03,  p  = 0.03], and for MM [Mdiff = 0.09, SE = 0.03,  p  = 0.03].",['94 employees'],"['Mindfulness versus Physical Exercise', 'mindfulness meditation (MM) and physical exercise (PE']","['mental health', 'Mental Health, Stress and Immunoglobulin A during Lunch Breaks', 'time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ', 'perceived stress, general mental health, and immunoglobin A (IgA', 'Perceived stress and general mental health questionnaires and saliva samples']","[{'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",94.0,0.120693,"There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03,  p  = 0.03], and for MM [Mdiff = 0.09, SE = 0.03,  p  = 0.03].","[{'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Díaz-Silveira', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Rey Juan Carlos, Avda. Atenas s/n, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Carlos-María', 'Initials': 'CM', 'LastName': 'Alcover', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Rey Juan Carlos, Avda. Atenas s/n, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Burgos', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marcos', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Santed', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082839']
142,30894658,Blood pressure variability and outcome in acute ischemic and hemorrhagic stroke: a post hoc analysis of the HeadPoST study.,"The Head Positioning in Acute Stroke Trial (HeadPoST) is a pragmatic, international, cluster crossover randomized trial of 11,093 patients with acute stroke assigned to a lying-flat (0°) or sitting-up (head elevated ≥30°) position. This post hoc analysis aimed to determine the association between blood pressure variability (BPV) and outcomes for patients from a wide range of international clinical settings and how the association was modified by randomized head position. BPV was defined according to the standard criteria, with the key parameter considered the coefficient of variation (CV) of systolic BP (SBP) over 24 h. Outcome was ordinal 90-day Modified Rankin Scale (mRS) score. The association was analyzed by ordinal, logistic regression, hierarchical, mixed models with fixed intervention (lying flat vs. sitting up), and fixed period, random cluster, and random cluster-period, effects. Nine thousand one hundred and fifty six (8324 acute ischemic stroke and 817 intracerebral hemorrhage; mean age 68.1 years; 39.2% women) were included in the analysis. CV of SBP had a significant linear association with unfavorable shift of mRS at 90 days (adjusted odds ratio 1.06, 95% confidence interval 1.02-1.11; P = 0.01). There was no heterogeneity of the association by randomized head positioning. In addition, CV of diastolic BP (DBP) (1.08, 1.03-1.12; P = 0.001) over 24 h post stroke was significantly associated with 3-month poor outcome. The association was more apparent in sitting-up position (1.12, 1.06-1.19) compared with lying-flat position (1.03, 0.98-1.09) (P interaction = 0.005). BPV was associated with adverse stroke outcome, and the magnitude of the association was greater with sitting-up head positioning in terms of DBP variability.",2019,"The association was more apparent in sitting-up position (1.12, 1.06-1.19) compared with lying-flat position (1.03, 0.98-1.09) (P interaction = 0.005).","['patients from a wide range of international clinical settings', 'acute ischemic and hemorrhagic stroke', '11,093 patients with acute stroke assigned to a lying-flat (0°) or sitting-up (head elevated ≥30°) position', 'Nine thousand one hundred and fifty six (8324 acute ischemic stroke and 817 intracerebral hemorrhage; mean age 68.1 years; 39.2% women']",[],"['ordinal 90-day Modified Rankin Scale (mRS) score', 'BPV', 'blood pressure variability (BPV', 'Blood pressure variability', 'coefficient of variation (CV) of systolic BP (SBP', 'CV of diastolic BP (DBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0560837', 'cui_str': 'Does sit up (finding)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C4708915', 'cui_str': '9000'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",11093.0,0.113053,"The association was more apparent in sitting-up position (1.12, 1.06-1.19) compared with lying-flat position (1.03, 0.98-1.09) (P interaction = 0.005).","[{'ForeName': 'Jatinder S', 'Initials': 'JS', 'LastName': 'Minhas', 'Affiliation': 'Department of Cardiovascular Science, University of Leicester, Leicester, UK.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana Universidad del Desarrollo and Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Moullaali', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Veronica V', 'Initials': 'VV', 'LastName': 'Olavarria', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana Universidad del Desarrollo and Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, Australian Catholic University and St Vincent's Health Australia, Sydney, NSW, Australia.""}, {'ForeName': 'Octavio', 'Initials': 'O', 'LastName': 'Pontes-Neto', 'Affiliation': 'Ribeirão Preto Medical School, Univesity of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'De Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Jeyaraj D', 'Initials': 'JD', 'LastName': 'Pandian', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Gillian E', 'Initials': 'GE', 'LastName': 'Mead', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, The University of Central Lancashire, Preston, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia. canderson@georgeinstitute.org.au.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Science, University of Leicester, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of human hypertension,['10.1038/s41371-019-0193-z']
143,31981518,Detection of colorectal adenomas with a real-time computer-aided system (ENDOANGEL): a randomised controlled study.,"BACKGROUND


Colonoscopy performance varies among endoscopists, impairing the discovery of colorectal cancers and precursor lesions. We aimed to construct a real-time quality improvement system (ENDOANGEL) to monitor real-time withdrawal speed and colonoscopy withdrawal time and to remind endoscopists of blind spots caused by endoscope slipping. We also aimed to evaluate the effectiveness of this system for improving adenoma yield of everyday colonoscopy.
METHODS


The ENDOANGEL system was developed using deep neural networks and perceptual hash algorithms. We recruited consecutive patients aged 18-75 years from Renmin Hospital of Wuhan University in China who provided written informed consent. We randomly assigned patients (1:1) using computer-generated random numbers and block randomisation (block size of four) to either colonoscopy with the ENDOANGEL system or unassisted colonoscopy (control). Endoscopists were not masked to the random assignment but analysts and patients were unaware of random assignments. The primary endpoint was the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected at colonoscopy. The primary analysis was done per protocol (ie, in all patients having colonoscopy done in accordance with the assigned intervention) and by intention to treat (ie, in all randomised patients). This trial is registered with http://www.chictr.org.cn, ChiCTR1900021984.
FINDINGS


Between June 18, 2019, and Sept 6, 2019, 704 patients were randomly allocated colonoscopy with the ENDOANGEL system (n=355) or unassisted (control) colonoscopy (n=349). In the intention-to-treat population, ADR was significantly greater in the ENDOANGEL group than in the control group, with 58 (16%) of 355 patients allocated ENDOANGEL-assisted colonoscopy having one or more adenomas detected, compared with 27 (8%) of 349 allocated control colonoscopy (odds ratio [OR] 2·30, 95% CI 1·40-3·77; p=0·0010). In the per-protocol analysis, findings were similar, with 54 (17%) of 324 patients assigned ENDOANGEL-assisted colonoscopy and 26 (8%) of 318 patients assigned control colonoscopy having one or more adenomas detected (OR 2·18, 95% CI 1·31-3·62; p=0·0026). No adverse events were reported.
INTERPRETATION


The ENDOANGEL system significantly improved the adenoma yield during colonoscopy and seems to be effective and safe for use during routine colonoscopy.
FUNDING


Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Hubei Province Major Science and Technology Innovation Project, and the National Natural Science Foundation of China.",2020,"The ENDOANGEL system significantly improved the adenoma yield during colonoscopy and seems to be effective and safe for use during routine colonoscopy.
","['Between June 18, 2019, and Sept 6, 2019, 704 patients were randomly allocated colonoscopy with the ENDOANGEL system (n=355) or unassisted (control) colonoscopy (n=349', 'consecutive patients aged 18-75 years from Renmin Hospital of Wuhan University in China who provided written informed consent']","['endoscope slipping', 'real-time computer-aided system', 'computer-generated random numbers and block randomisation (block size of four) to either colonoscopy with the ENDOANGEL system or unassisted colonoscopy (control']","['adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected at colonoscopy', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",704.0,0.14788,"The ENDOANGEL system significantly improved the adenoma yield during colonoscopy and seems to be effective and safe for use during routine colonoscopy.
","[{'ForeName': 'Dexin', 'Initials': 'D', 'LastName': 'Gong', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Ganggang', 'Initials': 'G', 'LastName': 'Mu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhengqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'An', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiaoda', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'School of Resource and Environmental Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Resource and Environmental Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'School of Resource and Environmental Sciences, Wuhan University, Wuhan, China.'}, {'ForeName': 'Youming', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Suqin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China. Electronic address: yuhonggang1968@163.com.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30413-3']
144,31981516,"Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial.","BACKGROUND


Neurodegeneration is the pathological substrate that causes major disability in secondary progressive multiple sclerosis. A synthesis of preclinical and clinical research identified three neuroprotective drugs acting on different axonal pathobiologies. We aimed to test the efficacy of these drugs in an efficient manner with respect to time, cost, and patient resource.
METHODS


We did a phase 2b, multiarm, parallel group, double-blind, randomised placebo-controlled trial at 13 clinical neuroscience centres in the UK. We recruited patients (aged 25-65 years) with secondary progressive multiple sclerosis who were not on disease-modifying treatment and who had an Expanded Disability Status Scale (EDSS) score of 4·0-6·5. Participants were randomly assigned (1:1:1:1) at baseline, by a research nurse using a centralised web-based service, to receive twice-daily oral treatment of either amiloride 5 mg, fluoxetine 20 mg, riluzole 50 mg, or placebo for 96 weeks. The randomisation procedure included minimisation based on sex, age, EDSS score at randomisation, and trial site. Capsules were identical in appearance to achieve masking. Patients, investigators, and MRI readers were unaware of treatment allocation. The primary outcome measure was volumetric MRI percentage brain volume change (PBVC) from baseline to 96 weeks, analysed using multiple regression, adjusting for baseline normalised brain volume and minimisation criteria. The primary analysis was a complete-case analysis based on the intention-to-treat population (all patients with data at week 96). This trial is registered with ClinicalTrials.gov, NCT01910259.
FINDINGS


Between Jan 29, 2015, and June 22, 2016, 445 patients were randomly allocated amiloride (n=111), fluoxetine (n=111), riluzole (n=111), or placebo (n=112). The primary analysis included 393 patients who were allocated amiloride (n=99), fluoxetine (n=96), riluzole (n=99), and placebo (n=99). No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]). No emergent safety issues were reported. The incidence of serious adverse events was low and similar across study groups (ten [9%] patients in the amiloride group, seven [6%] in the fluoxetine group, 12 [11%] in the riluzole group, and 13 [12%] in the placebo group). The most common serious adverse events were infections and infestations. Three patients died during the study, from causes judged unrelated to active treatment; one patient assigned amiloride died from metastatic lung cancer, one patient assigned riluzole died from ischaemic heart disease and coronary artery thrombosis, and one patient assigned fluoxetine had a sudden death (primary cause) with multiple sclerosis and obesity listed as secondary causes.
INTERPRETATION


The absence of evidence for neuroprotection in this adequately powered trial indicates that exclusively targeting these aspects of axonal pathobiology in patients with secondary progressive multiple sclerosis is insufficient to mitigate neuroaxonal loss. These findings argue for investigation of different mechanistic targets and future consideration of combination treatment trials. This trial provides a template for future simultaneous testing of multiple disease-modifying medicines in neurological medicine.
FUNDING


Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership, UK Multiple Sclerosis Society, and US National Multiple Sclerosis Society.",2020,"No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]).","['recruited patients (aged 25-65 years) with secondary progressive multiple sclerosis who were not on disease-modifying treatment and who had an Expanded Disability Status Scale (EDSS) score of 4·0-6·5', '13 clinical neuroscience centres in the UK', '393 patients who were allocated', 'secondary progressive multiple sclerosis (MS-SMART', 'primary cause) with multiple sclerosis and obesity listed as secondary causes', 'Between Jan 29, 2015, and June 22, 2016, 445 patients', 'patients with secondary progressive multiple sclerosis']","['PBVC (amiloride vs placebo', 'amiloride 5 mg, fluoxetine 20 mg, riluzole 50 mg, or placebo', 'fluoxetine', 'neuroprotective drugs', 'amiloride', 'placebo', 'riluzole']","['ischaemic heart disease and coronary artery thrombosis', 'sudden death', 'volumetric MRI percentage brain volume change (PBVC', 'incidence of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C1597541', 'cui_str': 'Riluzole 50 MG [Rilutek]'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0242912', 'cui_str': 'Neuroprotective Drugs'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}]","[{'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0010072', 'cui_str': 'Coronary Thrombosis'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",445.0,0.577543,"No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]).","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK. Electronic address: j.chataway@ucl.ac.uk.'}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'De Angelis', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Connick', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Plantone', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'John', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Stutters', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'MacManus', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Prados Carrasco', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Department of Medical Physics and Biomedical Engineering, Centre for Medical Image Computing, UCL, London, UK; Universitat Oberta de Catalunya, Barcelona, Spain; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Department of Medical Physics and Biomedical Engineering, Centre for Medical Image Computing, UCL, London, UK; Department of Radiology and Nuclear Medicine, VU University Medical Centre, Amsterdam, Netherlands; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Ourselin', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Braisher', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Cranswick', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sue H', 'Initials': 'SH', 'LastName': 'Pavitt', 'Affiliation': 'Dental Translational and Clinical Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Claudia Angela', 'Initials': 'CA', 'LastName': 'Gandini Wheeler-Kingshott', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Brain MRI 3T Research Center, IRCCS Mondino Foundation, Pavia, Italy; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Hawkins', 'Affiliation': 'Keele Medical School and Institute for Science and Technology in Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'Department of Neuroscience, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bastow', 'Affiliation': 'Patient Representative, Multiple Sclerosis Society, London, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Statistics and Epidemiology, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Siddharthan', 'Initials': 'S', 'LastName': 'Chandran', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30485-5']
145,32322692,Postal recruitment for genetic studies of preterm birth: A feasibility study.,"Background:  Preterm birth (PTB) represents the leading cause of neonatal death. Large-scale genetic studies are necessary to determine genetic influences on PTB risk, but prospective cohort studies are expensive and time-consuming. We investigated the feasibility of retrospective recruitment of post-partum women for efficient collection of genetic samples, with self-collected saliva for DNA extraction from themselves and their babies, alongside self-recollection of pregnancy and birth details to phenotype PTB.  Methods:  708 women who had participated in the OPPTIMUM trial (a randomised trial of progesterone pessaries to prevent PTB [ISRCTN14568373]) and consented to further contact were invited to provide self-collected saliva from themselves and their babies. DNA was extracted from Oragene OG-500 (adults) and OG-575 (babies) saliva kits and the yield measured by Qubit. Samples were analysed using a panel of Taqman single nucleotide polymorphism (SNP) assays. A questionnaire designed to meet the minimum data set required for phenotyping PTB was included. Questionnaire responses were transcribed and analysed for concordance with prospective trial data using Cohen's kappa (  k ).  Results:  Recruitment rate was 162/708 (23%) for self-collected saliva samples and 157/708 (22%) for questionnaire responses. 161 samples from the mother provided DNA with median yield 59.0µg (0.4-148.9µg). 156 samples were successfully genotyped (96.9%). 136 baby samples had a median yield 11.5µg (0.1-102.7µg); two samples failed DNA extraction. 131 baby samples (96.3%) were successfully genotyped. Concordance between self-recalled birth details and prospective birth details was excellent (  k >0.75) in 4 out of 10 key fields for phenotyping PTB (mode of delivery, labour onset, ethnicity and maternal age at birth).  Conclusion:  This feasibility study demonstrates that self-collected DNA samples from mothers and babies were sufficient for genetic analysis but yields were variable. Self-recollection of pregnancy and birth details was inadequate for accurately phenotyping PTB, highlighting the need for alternative strategies for investigating genetic links with PTB.",2020,"The highest rates of concordance were found for mode of birth (154/156 [99%]), smoking status (151/157 [96%]) and ethnicity (149/156 [96%]).  ","['708 women who had participated in the OPPTIMUM trial', '136 baby samples had a median yield 11.5µg (0.1-102.7µg); two samples failed DNA extraction', 'preterm birth', '131 baby samples (96.3%) were successfully genotyped']",['progesterone pessaries'],"['Questionnaire responses', 'smoking status', 'Recruitment rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C3839098', 'cui_str': 'Deoxyribonucleic acid extraction technique'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",708.0,0.0435535,"The highest rates of concordance were found for mode of birth (154/156 [99%]), smoking status (151/157 [96%]) and ethnicity (149/156 [96%]).  ","[{'ForeName': 'Oonagh E', 'Initials': 'OE', 'LastName': 'Keag', 'Affiliation': 'Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'Edinburgh Clinical Research Facility, Western General Hospital, Edinburgh, EH4 2XU, UK.'}, {'ForeName': 'Aoibheann', 'Initials': 'A', 'LastName': 'Bradley', 'Affiliation': 'Queen Margaret Hospital, Dunfermline, KY12 0SU, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Deakin', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Whyte', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Stock', 'Affiliation': 'Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.15207.2']
146,32213522,Built environment changes and active transport to school among adolescents: BEATS Natural Experiment Study protocol.,"INTRODUCTION


Natural experiments are considered a priority for examining causal associations between the built environment (BE) and physical activity (PA) because the randomised controlled trial design is rarely feasible. Few natural experiments have examined the effects of walking and cycling infrastructure on PA and active transport in adults, and none have examined the effects of such changes on PA and active transport to school among adolescents. We conducted the Built Environment and Active Transport to School (BEATS) Study in Dunedin city, New Zealand, in 2014-2017. Since 2014, on-road and off-road cycling infrastructure construction has occurred in some Dunedin neighbourhoods, including the neighbourhoods of 6 out of 12 secondary schools. Pedestrian-related infrastructure changes began in 2018. As an extension of the BEATS Study, the BEATS Natural Experiment (BEATS-NE) (2019-2022) will examine the effects of BE changes on adolescents' active transport to school in Dunedin, New Zealand.
METHODS AND ANALYSIS


The BEATS-NE Study will employ contemporary ecological models for active transport that account for individual, social, environmental and policy factors. The published BEATS Study methodology (surveys, accelerometers, mapping, Geographic Information Science analysis and focus groups) and novel methods (environmental scan of school neighbourhoods and participatory mapping) will be used. A core component continues to be the community-based participatory approach with the sustained involvement of key stakeholders to generate locally relevant data, and facilitate knowledge translation into evidence-based policy and planning.
ETHICS AND DISSEMINATION


The BEATS-NE Study has been approved by the University of Otago Ethics Committee (reference: 17/188). The results will be disseminated through scientific publications and symposia, and reports and presentations to stakeholders.
TRIAL REGISTRATION NUMBER


ACTRN12619001335189.",2020,"Since 2014, on-road and off-road cycling infrastructure construction has occurred in some Dunedin neighbourhoods, including the neighbourhoods of 6 out of 12 secondary schools.","['Dunedin city, New Zealand, in 2014-2017', 'adolescents', ""adolescents' active transport to school in Dunedin, New Zealand""]",[],[],"[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005529', 'cui_str': 'Uphill Transport'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],[],2022.0,0.0396933,"Since 2014, on-road and off-road cycling infrastructure construction has occurred in some Dunedin neighbourhoods, including the neighbourhoods of 6 out of 12 secondary schools.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mandic', 'Affiliation': 'Active Living Laboratory, School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand sandra.mandic@otago.ac.nz.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hopkins', 'Affiliation': 'Transport Study Unit, School of Geography and the Environment, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'García Bengoechea', 'Affiliation': 'Health Research Institute, Department of Physical Education and Sport Sciences, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'School of Surveying, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sandretto', 'Affiliation': 'College of Education, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Coppell', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ergler', 'Affiliation': 'School of Geography, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Keall', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rolleston', 'Affiliation': 'Faculty of Health, Sport and Human Performance, University of Waikato, Hamilton, Waikato, New Zealand.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Kidd', 'Affiliation': ""Dunedin Secondary Schools' Partnership, Dunedin, New Zealand.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': ""Dunedin Secondary Schools' Partnership, Dunedin, New Zealand.""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Spence', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Alberta, Edmonton, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-034899']
147,31614295,Reduction of postural sway in athletes with chronic low back pain through eight weeks of inspiratory muscle training: A randomized controlled trial.,"BACKGROUND


Postural control and respiratory function are mechanically and neuromuscularly dependent on each other. The present study was conducted to determine the effects of inspiratory muscle training on postural sway in athletes with chronic low back pain.
METHODS


Twenty-four patients were randomly selected as the experimental group and 23 patients as the control group. The experimental group underwent the inspiratory muscle training protocol for eight weeks, seven days per week and twice daily. The postural sway variables were recorded using a plantar pressure measurement device. The postural sway variables were recorded when performing overhead and single leg squat. Patient's perceived low back pain was assessed using Visual Analog Scale. Disability was assessed using the Athletes Disability Index questionnaire. Patient depression/anxiety was assessed using the Patient Health Questionnaire-4.
FINDINGS


The results of the two-way ANOVA in the overhead squat test showed that postural sway indices significantly decreased in the experimental group after 8-weeks intervention compared to the pre-test values. The results of the two-way ANOVA in single leg squat test showed significant differences between the pre- and post-test in the experimental group in the postural sway indices except for the factor of standard deviation Y, also compared to the pre-test value, pain was significantly decreased in the experimental group.
INTERPRETATION


The 8-weeks inspiratory muscle training decreased postural sway in athletes with chronic low back pain when performing the overhead and single leg squat. In addition, the pain index decreased after 8-weeks of inspiratory muscle training.",2019,The 8-weeks inspiratory muscle training decreased postural sway in athletes with chronic low back pain when performing the overhead and single leg squat.,"['Twenty-four patients were randomly selected as the experimental group and 23 patients as the control group', 'athletes with chronic low back pain', 'athletes with chronic low back pain when performing the overhead and single leg squat']","['inspiratory muscle training', '8-weeks inspiratory muscle training decreased postural sway', 'inspiratory muscle training protocol']","['postural sway', 'Athletes Disability Index questionnaire', 'pain', 'Disability', 'low back pain', 'postural sway indices', 'Patient depression/anxiety', 'Visual Analog Scale', 'pain index', 'postural sway variables']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",24.0,0.0372512,The 8-weeks inspiratory muscle training decreased postural sway in athletes with chronic low back pain when performing the overhead and single leg squat.,"[{'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Gholami Borujeni', 'Affiliation': 'Department of Corrective Exercises and Sport Injury, Faculty of Physical Education and Sport Sciences, Bu Ali Sina University, Hamedan, Iran. Electronic address: b.gholami94@basu.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yalfani', 'Affiliation': 'Department of Corrective Exercises and Sport Injury, Faculty of Physical Education and Sport Sciences, Bu Ali Sina University, Hamedan, Iran. Electronic address: yalfani@basu.ac.ir.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.09.006']
148,32325012,"Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial.","BACKGROUND


Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections.
METHODS


In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual.
FINDINGS


Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ 2  test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
INTERPRETATION


The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery.
FUNDING


Fundación Asociación Española de Coloproctología.",2020,"No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
","['patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated', '13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention', 'Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated', 'Between May 2, 2015, and April 15, 2017', 'colon surgery (ORALEV', '582 patients for eligibility, of whom 565 were eligible']","['cefuroxime 1·5 g and metronidazole', 'metronidazole', 'ciprofloxacin', 'no oral antibiotics (n=282) or oral antibiotics', 'Preoperative oral antibiotics and surgical-site infections', 'oral antibiotics', 'oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group']","['risk of surgical-site infections', 'incidence of surgical-site infections', 'local complications, surgical complications, or medical complications', 'More complications (including surgical-site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0586901', 'cui_str': 'Colorectal surgeon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1510475', 'cui_str': 'Diverticula of intestine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0149750', 'cui_str': 'Partial resection of colon'}, {'cui': 'C0192871', 'cui_str': 'Total colectomy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",582.0,0.193492,"No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
","[{'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Espin Basany', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain. Electronic address: eespin@vhebron.net.""}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Solís-Peña', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pellino', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kreisler', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}, {'ForeName': 'Doménico', 'Initials': 'D', 'LastName': 'Fraccalvieri', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Muinelo-Lorenzo', 'Affiliation': 'Colorectal Surgery Unit, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Maseda-Díaz', 'Affiliation': 'Colorectal Surgery Unit, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'García-González', 'Affiliation': 'Coloproctology Surgery Unit, Department of General and Digestive Surgery, Cruces University Hospital, Barakaldo, Bzkaia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santamaría-Olabarrieta', 'Affiliation': 'Coloproctology Surgery Unit, Department of General and Digestive Surgery, Cruces University Hospital, Barakaldo, Bzkaia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Codina-Cazador', 'Affiliation': 'Colorectal Surgery Unit, Hosiptal Universitario Gerona, Universidad de Gerona, Girona, Spain.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Biondo', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30075-3']
149,32325037,"Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial.","BACKGROUND


The Middle East respiratory syndrome coronavirus (MERS-CoV) causes a respiratory disease with a case fatality rate of up to 35%. Given its potential to cause a public health emergency and the absence of efficacious drugs or vaccines, MERS is one of the WHO priority diseases warranting urgent research and development of countermeasures. We aimed to assess safety and tolerability of an anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine candidate that expresses the MERS-CoV spike glycoprotein, MVA-MERS-S, in healthy adults.
METHODS


This open-label, phase 1 trial was done at the University Medical Center Hamburg-Eppendorf (Hamburg, Germany). Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2  and weight of more than 50 kg at screening, and a negative pregnancy test for women. A key exclusion criterion was a previous MVA vaccination. For the prime immunisation, participants received doses of 1 × 10 7  plaque-forming unit (PFU; low-dose group) or 1 × 10 8  PFU (high-dose group) MVA-MERS-S intramuscularly. A second identical dose was administered intramuscularly as a booster immunisation 28 days after first injection. As a control group for immunogenicity analyses, blood samples were drawn at identical study timepoints from six healthy adults, who did not receive any injections. The primary objectives of the study were safety and tolerability of the two dosage levels and reactogenicity after administration. Immunogenicity was assessed as a secondary endpoint by ELISA and neutralisation tests. T-cell immunity was evaluated by interferon-γ-linked enzyme-linked immune absorbent spot assay. All participants who were vaccinated at least once were included in the safety analysis. Immunogenicity was analysed in the participants who completed 6 months of follow-up. This trial is registered with ClinicalTrials.gov, NCT03615911, and EudraCT, 2014-003195-23 FINDINGS: From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group) were enrolled and received the first dose of the vaccine according to their group allocation. Of these, 23 participants (12 in the low-dose group and 11 in the high-dose group) received a second dose of MVA-MERS-S according to their group allocation after a 28-day interval and completed follow-up. Homologous prime-boost immunisation with MVA-MERS-S revealed a benign safety profile with only transient mild-to-moderate reactogenicity. Participants had no severe or serious adverse events. 67 vaccine-related adverse events were reported in ten (71%) of 14 participants in the low-dose group, and 111 were reported in ten (83%) of 12 participants in the high-dose group. Solicited local reactions were the most common adverse events: pain was observed in 17 (65%; seven in the low-dose group vs ten in the high-dose group) participants, swelling in ten (38%; two vs eight) participants, and induration in ten (38%; one vs nine) participants. Headaches (observed in seven participants in the low-dose group vs nine in the high-dose group) and fatigue or malaise (ten vs seven participants) were the most common solicited systemic adverse events. All adverse events resolved swiftly (within 1-3 days) and without sequelae. Following booster immunisation, nine (75%) of 12 participants in the low-dose group and 11 (100%) participants in the high-dose group showed seroconversion using a MERS-CoV S1 ELISA at any timepoint during the study. Binding antibody titres correlated with MERS-CoV-specific neutralising antibodies (Spearman's correlation r=0·86 [95% CI 0·6960-0·9427], p=0·0001). MERS-CoV spike-specific T-cell responses were detected in ten (83%) of 12 immunised participants in the low-dose group and ten (91%) of 11 immunised participants in the high-dose group.
INTERPRETATION


Vaccination with MVA-MERS-S had a favourable safety profile without serious or severe adverse events. Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development.
FUNDING


German Center for Infection Research.",2020,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","['Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2  and weight of more than 50 kg at screening, and a negative pregnancy test for women', 'six healthy adults, who did not receive any injections', 'healthy adults', 'All participants who were vaccinated at least once were included in the safety analysis', 'Middle East respiratory syndrome', 'University Medical Center Hamburg-Eppendorf (Hamburg, Germany', ' From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group', '2014-003195-23', '23 participants (12 in the low-dose group and 11 in the high-dose group']","['1\u2008×\u200810 7  plaque-forming unit (PFU; low-dose group) or 1\u2008×\u200810 8  PFU (high-dose group) MVA-MERS-S intramuscularly', 'MVA-MERS-S', 'modified vaccinia virus Ankara vector vaccine candidate', 'anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine']","['adverse events', 'fatigue or malaise', 'Safety and immunogenicity', 'MERS-CoV spike-specific T-cell responses', 'safety and tolerability', 'Immunogenicity', 'severe or serious adverse events', 'seroconversion using a MERS-CoV S1 ELISA', 'Headaches', 'adverse events: pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042216', 'cui_str': 'Vaccinia virus'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",6.0,0.132455,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dahlke', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Krähling', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Nisreen M A', 'Initials': 'NMA', 'LastName': 'Okba', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eickmann', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Asisa', 'Initials': 'A', 'LastName': 'Volz', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesterkamp', 'Affiliation': 'German Center for Infection Research, Hanover-Brunswick, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Borregaard', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'My L', 'Initials': 'ML', 'LastName': 'Ly', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Zinser', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bartels', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Joseph S H', 'Initials': 'JSH', 'LastName': 'Poetsch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Neumann', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fux', 'Affiliation': 'Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmiedel', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Haagmans', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Sutter', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Marylyn M', 'Initials': 'MM', 'LastName': 'Addo', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany. Electronic address: m.addo@uke.de.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30248-6']
150,31733140,Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.,"BACKGROUND


Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis.
METHODS


We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed.
RESULTS


A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P = 0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P = 0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P = 0.03).
CONCLUSIONS


Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo. (Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov number, NCT02551094.).",2019,"The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization.","['patients with a recent myocardial infarction', 'A total of 4745 patients were enrolled; 2366 patients', 'patients recruited within 30 days after a myocardial infarction']","['Low-Dose Colchicine', 'Colchicine', 'placebo', 'colchicine', 'low-dose colchicine']","['resuscitated cardiac arrest', 'Diarrhea', 'composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization', 'hazard ratios', 'Pneumonia', 'ischemic cardiovascular events', 'Efficacy and Safety', 'myocardial infarction', 'serious adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction (situation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2366.0,0.670027,"The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization.","[{'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kouz', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Waters', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Fausto J', 'Initials': 'FJ', 'LastName': 'Pinto', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Gamra', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Ghassan S', 'Initials': 'GS', 'LastName': 'Kiwan', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Angoulvant', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Grégoire', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Lavoie', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rhainds', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Mylène', 'Initials': 'M', 'LastName': 'Provencher', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Blondeau', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Orfanos', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': ""L'Allier"", 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Guertin', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': ""From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in France.""}]",The New England journal of medicine,['10.1056/NEJMoa1912388']
151,30538299,Lifestyle interventions in Muslim patients with metabolic syndrome-a feasibility study.,"Obesity, metabolic syndrome, and type-2 diabetes mellitus are common in Muslim patients living in Germany, most of whom are of Turkish origin. Lifestyle interventions must be tailored to religion and ethnicity. We tested the body weight-reducing effect of a 30% calorie-reduced intake diet, adjusted to individual energy expenditure, eating habits, and food preferences in a Turkish-background cohort. Eighty subjects were randomized to activity advice only or to a step-count device to monitor and document physical activity before and after the 12-week intervention. Fifty-three patients completed the study. Lifestyle interventions were effective in these Muslim subjects. Body weight was reduced by 6%; activity monitoring provided a modestly increased effect to 8%. Blood glucose, HbA1c, triglycerides and cholesterol improved also substantially. Subjects receiving metformin could reduce their dosage. Our data show that Muslim Turkish patients respond to interventions if these are tailored to their needs.",2019,"Blood glucose, HbA1c, triglycerides and cholesterol improved also substantially.","['Fifty-three patients completed the study', 'Muslim patients with metabolic syndrome', 'Eighty subjects']","['Lifestyle interventions', 'metformin']","['Blood glucose, HbA1c, triglycerides and cholesterol', 'Body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026870', 'cui_str': 'Muslims'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",80.0,0.0165118,"Blood glucose, HbA1c, triglycerides and cholesterol improved also substantially.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Aktas', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mähler', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hamm', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Perger', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Simon', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Westenhöfer', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Friedrich C', 'Initials': 'FC', 'LastName': 'Luft', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boschmann', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany. michael.boschmann@charite.de.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0371-z']
152,31343103,Noninvasive long-term ECG monitoring vs. loop recorder implantation for the atrial fibrillation management.,"OBJECTIVE


The objective of the study was to estimate the efficacy of a noninvasive ambulatory ECG monitoring (NIAM) in comparison with implantable loop recorder (ILR) in patients with atrial fibrillation (AF).
METHODS


Thirty-two patients 58 [47; 73] years of age with AF were included in the study. Patients were randomized into two groups: in group I (n = 15), ""Reveal XT"" ILR was used for invasive ECG monitoring up to 3 months; in group II (n = 17), ""Spyder"" device was used for NIAM up to 14 days.
RESULTS


In both groups, at least one AF episode was detected during 14 days of monitoring. The overall count of AF episodes was 25 in NIAM group and 28 in ILR group. The mean time between AF start and its registration by a physician was 8 hr in NIAM group and 20 hr in ILR group (p = .005). The diagnostic value parameters of NIAM were as follows: sensitivity-80.1%, specificity-73.1%; positive predictive value-74.1%; and negative predictive value-79.2%. The same parameters in ILR group were comparable with NIAM: sensitivity-78.6%; specificity-69%; positive predictive value-71%; and negative predictive value-77%. At the same time, continued monitoring with ILR for longer than two weeks did not lead to a significant change in the sensitivity and specificity of the method.
CONCLUSION


In patients with paroxysmal AF, the diagnostic value of both NIAM and ILR is comparable. An increase in the duration of ECG monitoring for longer than two weeks does not provide additional diagnostic information.",2020,The same parameters in ILR group were comparable with NIAM: sensitivity-78.6%; specificity-69%; positive predictive value-71%; and negative predictive value-77%.,"['patients with atrial fibrillation (AF', 'Thirty-two patients 58 [47; 73] years of age with AF were included in the study']","['implantable loop recorder (ILR', 'Spyder"" device was used for NIAM up to 14\xa0days', 'Reveal XT"" ILR', 'noninvasive ambulatory ECG monitoring (NIAM', 'Noninvasive long-term ECG monitoring vs. loop recorder implantation']","['duration of ECG monitoring', 'sensitivity and specificity', 'mean time between AF start and its registration by a physician', 'overall count of AF episodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4552498', 'cui_str': 'Implantable loop recorder'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1955976', 'cui_str': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C0013799', 'cui_str': 'Monitoring, Ambulatory Electrocardiographic'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0182913', 'cui_str': 'Recorder'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",32.0,0.0216492,The same parameters in ILR group were comparable with NIAM: sensitivity-78.6%; specificity-69%; positive predictive value-71%; and negative predictive value-77%.,"[{'ForeName': 'Sergey E', 'Initials': 'SE', 'LastName': 'Mamchur', 'Affiliation': 'Federal state budgetary scientific institution ""Research institute for complex issues of cardiovascular diseases,"", Kemerovo, Russia.'}, {'ForeName': 'Egor A', 'Initials': 'EA', 'LastName': 'Khomenko', 'Affiliation': 'Federal state budgetary scientific institution ""Research institute for complex issues of cardiovascular diseases,"", Kemerovo, Russia.'}, {'ForeName': 'Tatiana Y', 'Initials': 'TY', 'LastName': 'Chichkova', 'Affiliation': 'Federal state budgetary scientific institution ""Research institute for complex issues of cardiovascular diseases,"", Kemerovo, Russia.'}, {'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'Romanova', 'Affiliation': 'Federal state budgetary scientific institution ""Research institute for complex issues of cardiovascular diseases,"", Kemerovo, Russia.'}, {'ForeName': 'Veronika V', 'Initials': 'VV', 'LastName': 'Evtushenko', 'Affiliation': 'Federal state budgetary scientific institution ""Research institute for complex issues of cardiovascular diseases,"", Kemerovo, Russia.'}, {'ForeName': 'Olga M', 'Initials': 'OM', 'LastName': 'Polikutina', 'Affiliation': 'Federal state budgetary scientific institution ""Research institute for complex issues of cardiovascular diseases,"", Kemerovo, Russia.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12675']
153,31993781,Low-dose ofatumumab for multidrug-resistant nephrotic syndrome in children: a randomized placebo-controlled trial.,"BACKGROUND


Children with multidrug-resistant nephrotic syndrome (MRNS) are exposed to drug toxicity (steroids/calcineurin inhibitors (CNI)/mycophenolate mofetil (MMF)) and have an increased risk of kidney disease progression. In small case series, the fully humanized anti-CD20 antibody ofatumumab (OFA) induced remission in children with MRNS when at high dose (10,300 mg/1.73 m 2 ) and partial remission at standard dose (1000 mg/1.73 m 2 ).
METHODS


This double-blind randomized placebo-controlled trial tested the efficacy of single infusion OFA in children with proven MRNS and initial chronic renal failure (eGFR [median/range] 119/38-155 ml/min/1.73 m 2  in Placebo arm vs. 65/19-103 ml/min/1.73 m 2  Intervention). Children who had been resistant to a combination of CNI and steroids, with or without MMF or rituximab, were randomized to receive single infusion OFA (1500 mg/1.73 m 2 ) (Intervention arm) or normal saline (Placebo arm). We assessed complete or partial remission of proteinuria after 3 months (primary outcome), and after 6 and 12 months (secondary outcomes), as well as progression to end-stage kidney disease.
RESULTS


After 13 of the planned 50 children (25%) were randomized, the data safety and monitoring board recommended study termination for futility. All 13 children remained nephrotic. Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period. Circulating CD20 was reduced following OFA infusion and remained low for > 3 months.
CONCLUSIONS


OFA given in one single infusion of 1500 mg/1.73 m 2  doses does not induce remission in MRNS. Regimens based on higher OFA doses should be tested in clinical trials.
TRIAL REGISTRATION


https://clinicaltrials.gov: NCT02394106.",2020,"Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period.","['Children with multidrug-resistant nephrotic syndrome (MRNS', 'children', 'After 13 of the planned 50 children (25', 'children with proven MRNS and initial chronic renal failure (eGFR [median/range] 119/38-155\xa0ml', 'Children who had been resistant to a combination of CNI and steroids, with or without MMF or']","['Placebo', 'rituximab', 'normal saline (Placebo', 'renal replacement therapy', 'placebo', 'single infusion OFA', 'toxicity (steroids/calcineurin inhibitors (CNI)/mycophenolate mofetil (MMF', 'OFA']","['Renal function', 'progression to end-stage kidney disease', 'Circulating CD20', 'complete or partial remission of proteinuria', 'nephrotic']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",5.0,0.799336,"Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period.","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Pisani', 'Affiliation': 'Division of Nephrology, School of Nephrology, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bodria', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Caridi', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Maria Ludovica', 'Initials': 'ML', 'LastName': ""Degl'Innocenti"", 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Gian Marco', 'Initials': 'GM', 'LastName': 'Ghiggeri', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy. gmarcoghiggeri@gaslini.org.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04481-y']
154,32275028,High thoracic epidural decreases perioperative myocardial ischemia and improves left ventricle function in aortic valve replacement alone or in addition to cabg surgery even with increased left ventricle mass index.,"Introduction


High thoracic epidural (HTE) may reduce perioperative tachyarrhythmias, respiratory complications and myocardial ischemia (MI) and it may increase coronary perfusion and myocardial oxygen balance through sympatholysis and pain control. The aim of this study is to investigate the benefit of HTE in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG).
Methods


This prospective randomized controlled study was conducted on 80 patients (40 with increased left ventricular mass index (LVMI) and 40 with normal LVMI) who were equally randomised (n = 40) to receive either GA with HTE (HTE group) or GA alone (GA group). Heart rate (HR), mean arterial blood pressure (MAP) and the incidence of ischemic ECG changes were recorded. LV functions (preoperative and postoperative by transthoracic echocardiography and intraoperative by transoesophageal echocardiography) were measured preoperative, intraoperative and till 48 H postoperative.
Results


There was no significant difference in the baseline values of all measurements. HR and MAP were lower, and LV functions were improved in HTE group intraoperatively and postoperatively. Ischemic ECG changes were significantly lower in HTE group; with 42.9% intraoperative risk reduction (95% CI: 0.195-0.943) and 46.6% postoperative risk reduction (95% CI 0.227-0.952) as compared to GA group. The risk of ischemia was significantly higher in patients with increased LVMI in GA group (2.25 times compared to normal LVMI patients with 95% CI: 1.195-4.236), but it wasn't increased in HTE group. LV functions were significantly improved from the induction to 48 H postoperative in HTE group as compared to GA group.
Conclusion


HTE reduced the incidence of MI and improved the LV function, even with increased LVM, in patients undergoing AVR alone or in addition to CABG.",2020,Ischemic ECG changes were significantly lower in HTE group; with 42.9% intraoperative risk reduction (95% CI: 0.195-0.943) and 46.6% postoperative risk reduction (95% CI 0.227-0.952) as compared to GA group.,"['80 patients (40 with increased left ventricular mass index (LVMI) and 40 with normal LVMI) who were equally randomised (n = 40', 'patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG']","['GA with HTE (HTE group) or GA alone (GA group', 'HTE', 'LV functions (preoperative and postoperative by transthoracic echocardiography and intraoperative by transoesophageal echocardiography', 'Introduction\n\n\nHigh thoracic epidural (HTE']","['perioperative myocardial ischemia', 'HR and MAP', 'left ventricle function', 'LV functions', 'LV function', 'postoperative risk reduction', 'risk of ischemia', 'perioperative tachyarrhythmias, respiratory complications and myocardial ischemia (MI', 'Heart rate (HR), mean arterial blood pressure (MAP) and the incidence of ischemic ECG changes', 'Ischemic ECG changes', 'incidence of MI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}]",80.0,0.0486293,Ischemic ECG changes were significantly lower in HTE group; with 42.9% intraoperative risk reduction (95% CI: 0.195-0.943) and 46.6% postoperative risk reduction (95% CI 0.227-0.952) as compared to GA group.,"[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Elgebaly', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Sameh M', 'Initials': 'SM', 'LastName': 'Fathy', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Elbarbary', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Sallam', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_203_18']
155,32275030,Comparison of pectoral Nerve (PECS1) block with combined PECS1 and transversus thoracis muscle (TTM) block in patients undergoing cardiac implantable electronic device insertion - A pilot study.,"Background


Pectoral nerve (PECS1) block has been used for patients undergoing cardiac implantable electronic device (CIED) insertions, however, PECS1 block alone may lead to inadequate analgesia during tunneling and pocket creation because of the highly innervated chest wall. Transversus thoracis muscle plane (TTM) block targeting the anterior branches of T2-T6 intercostal nerves can be effectively used in combination with PECS1 for patients undergoing CIED insertion. The present study hypothesized that combined PECS1 and TTM blocks would provide effective analgesia for patients undergoing CIED insertion compared to PECS1 block alone.
Materials and Methods


Thirty adult patients between the age group of 18-85 years undergoing CIED insertion were enrolled in the study. A prospective, randomized, comparative, pilot study was conducted. A total of 30 patients were enrolled, who were randomized to either Group P: PECS1 block (n = 15) or Group PT: PECS1 and TTM blocks (n = 15). The intraoperative requirement of midazolam and local anesthetic and level of sedation by Ramsay sedation score were noted. The pain was assessed by visual analog scale (VAS) at rest and during a cough or deep breathing at 0 h, 3 h, 6 h, 12 h, and 24 h after the procedure.
Results


VAS scores at rest were significantly lower in group PT at 0, 3, 6, and 12 h postprocedure, and during cough at 0, 6, and 12 h after the procedure (P < 0.05). At 24 h, VAS scores were comparable between both groups. Intraoperative midazolam consumption was higher in group P compared to group PT (P= 0.002). Fourteen patients in group P received local anesthetic supplementation in comparison to only one patient in group PT (P = 0.0001). Thirteen patients in group P received the first rescue analgesia in comparison to three patients in group PT (P = 0.0003).
Conclusion


Combined PECS1 and TTM blocks provide superior analgesia, reduced net consumption of local anesthetic, sedative agents, and rescue analgesics compared to PECS1 block alone in patients undergoing CIED insertion.",2020,Intraoperative midazolam consumption was higher in group P compared to group PT (P= 0.002).,"['A total of 30 patients were enrolled, who were randomized to either Group P', 'patients undergoing cardiac implantable electronic device (CIED) insertions', 'Thirty adult patients between the age group of 18-85 years undergoing CIED insertion were enrolled in the study', 'patients undergoing cardiac implantable electronic device insertion ', 'patients undergoing CIED insertion']","['local anesthetic supplementation', 'pectoral Nerve (PECS1) block with combined PECS1 and transversus thoracis muscle (TTM) block', 'PECS1 and TTM', '\n\n\nPectoral nerve (PECS1) block', 'midazolam', 'PECS1 block (n = 15) or Group PT: PECS1 and TTM blocks', 'combined PECS1 and TTM blocks', 'Transversus thoracis muscle plane (TTM) block']","['Intraoperative midazolam consumption', 'net consumption of local anesthetic, sedative agents, and rescue analgesics', 'pain', 'visual analog scale (VAS) at rest and during a cough or deep breathing', 'VAS scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0036557', 'cui_str': 'Sedative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",30.0,0.0608201,Intraoperative midazolam consumption was higher in group P compared to group PT (P= 0.002).,"[{'ForeName': 'Thanigai', 'Initials': 'T', 'LastName': 'Arasu', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, Karnataka, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ragavendran', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, Karnataka, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Nagaraja', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, Karnataka, India.'}, {'ForeName': 'Naveen G', 'Initials': 'NG', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, Karnataka, India.'}, {'ForeName': 'Manjunatha N', 'Initials': 'MN', 'LastName': 'Vikram', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, Karnataka, India.'}, {'ForeName': 'Vikram Somashekhar', 'Initials': 'VS', 'LastName': 'Basappanavar', 'Affiliation': 'Department of Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Bangalore, Karnataka, India.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_254_18']
156,32275031,Combined effect of left stellate ganglion blockade and topical administration of papaverine on left internal thoracic artery blood flow in patients undergoing coronary revascularization.,"Background


Left stellate ganglion blockade (LSGB) may have additive effect to topical administration of papaverine on prevention of vasospasm of left internal thoracic artery (LITA).
Aims


This study aims to compare LITA blood flow with topical application of papaverine alone or in combination with LSGB.
Setting


Tertiary care hospital.
Design


Prospective randomized controlled study.
Materials and Methods


A total of 100 patients operated for coronary revascularization were randomly and equally allocated into two groups. In control Group-C, papaverine was applied topically during the dissection of LITA. In Group-S, the additional LSGB was performed. Blood flow was measured from cut end of the LITA for 15 s. Primary objectives of the evaluation were to observe differences in the LITA blood flow. Observing incidence of radial-femoral arterial pressure difference after cardiopulmonary bypass (CPB) was secondary objective.
Statistical Analysis


Student's unpaired t-test and Fisher's exact test to find out a significant difference between the groups.
Results


LITA flow in Group-S was insignificantly more (49.28 ± 7.88 ml/min) than Group-C (47.12 ± 7.24 ml/min), (P = 0.15). Radio-femoral arterial pressure difference remained low for 40 min after termination of CPB in the Group-S compared to the Group-C (-0.99 ± 1.85 vs. -1.92 ± 2.26).
Conclusion


Combining LSGB with papaverine does not increase the LITA blood flow compared to when the papaverine is used alone. However, ganglion blockade reduces radial-femoral arterial pressure difference after CPB. Blockade can be achieved successfully under the ultrasound guidance without any complications.",2020,"Radio-femoral arterial pressure difference remained low for 40 min after termination of CPB in the Group-S compared to the Group-C (-0.99 ± 1.85 vs. -1.92 ± 2.26).
","['100 patients operated for coronary revascularization', 'patients undergoing coronary revascularization']","['cardiopulmonary bypass (CPB', 'left stellate ganglion blockade', '\n\n\nLeft stellate ganglion blockade (LSGB', 'papaverine']","['Blood flow', 'left internal thoracic artery blood flow', 'LITA blood flow', 'Radio-femoral arterial pressure difference', 'radial-femoral arterial pressure difference']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0038246', 'cui_str': 'Structure of stellate ganglion'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0030350', 'cui_str': 'Papaverine'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0442038', 'cui_str': 'Radial'}]",100.0,0.0611042,"Radio-femoral arterial pressure difference remained low for 40 min after termination of CPB in the Group-S compared to the Group-C (-0.99 ± 1.85 vs. -1.92 ± 2.26).
","[{'ForeName': 'Roshith', 'Initials': 'R', 'LastName': 'Chandran', 'Affiliation': 'Department of Cardiac Anaesthesia, Freeman Hospital, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Rupa', 'Initials': 'R', 'LastName': 'Sreedhar', 'Affiliation': 'Department of Anesthesia, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Shrinivas', 'Initials': 'S', 'LastName': 'Gadhinglajkar', 'Affiliation': 'Department of Anesthesia, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Prashantkumar', 'Initials': 'P', 'LastName': 'Dash', 'Affiliation': 'Department of Anesthesia, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Jayakumar', 'Initials': 'J', 'LastName': 'Karunakaran', 'Affiliation': 'Department of CVTS, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Pillai', 'Affiliation': 'Department of CVTS, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_144_18']
157,32275032,"A comparative study of the analgesic effects of intravenous ketorolac, paracetamol, and morphine in patients undergoing video-assisted thoracoscopic surgery: A double-blind, active-controlled, randomized clinical trial.","Background


Opioids are traditionally used as the drug of choice for the management of postoperative pain. However, their use is limited in patients undergoing Video-assisted thoracic surgery (VATS), due to their side effects, such as respiratory depression, nausea, and vomiting.
Aim


In this double-blind active-controlled randomized study, we have compared the analgesic effects of ketorolac and paracetamol to morphine.
Methods


Patients were randomly chosen from a pool of candidates who were undergoing VATS and were divided into three groups. During the first 24 h postsurgery, patients in the control group received a cumulative dose of morphine 20 mg, while patients in two treatment groups received ketorolac 120 mg and paracetamol 4 g in total. Doses were administered as bolus immediately after surgery and infusion during the first 24 h. Patients' pain severity was evaluated by visual analogue scale rating (VAS) at rest and during coughing episodes.
Results


The average pain score at recovery time was 2.29 ± 2.13 and 2.26 ± 2.16 for ketorolac and paracetamol, respectively, and it was significantly lower than the morphine group with an average pain score of 3.87 (P = 0.003). Additionally, the VAS score during cough episodes was significantly higher in the control group throughout the study period compared to study groups. Comparison of mean morphine dose utilized as liberation analgesic (in case of patients had VAS >3) between three groups was not significantly different (P = 0.17).
Conclusion


Our study demonstrates the non-inferiority of ketorolac and paracetamol to morphine in controlling post-VATS pain without causing any significant side effects. We also show that ketorolac and paracetamol are superior to morphine in controlling pain during 2 h postsurgery.",2020,"Additionally, the VAS score during cough episodes was significantly higher in the control group throughout the study period compared to study groups.","['patients undergoing', 'Methods\n\n\nPatients were randomly chosen from a pool of candidates who were undergoing VATS', 'patients undergoing video-assisted thoracoscopic surgery']","['ketorolac and paracetamol to morphine', 'morphine', 'ketorolac and paracetamol', 'ketorolac, paracetamol, and morphine', 'Video-assisted thoracic surgery (VATS', 'ketorolac 120 mg and paracetamol']","['average pain score', 'pain severity', 'visual analogue scale rating (VAS', 'average pain score at recovery time', 'VAS score during cough episodes', 'controlling pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.190893,"Additionally, the VAS score during cough episodes was significantly higher in the control group throughout the study period compared to study groups.","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences; Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra M', 'Initials': 'ZM', 'LastName': 'Langari', 'Affiliation': 'Department of Pharmacovigilance, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Salamzadeh', 'Affiliation': 'Food Safety Research Center, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khalili', 'Affiliation': 'Anesthesiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Aqajani', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Jahangirifard', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_239_18']
158,31701153,Very Low Nicotine Content Cigarettes Disrupt the Feedback Loop of Affective States and Smoking Behavior.,"INTRODUCTION


Smoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period.
AIMS AND METHODS


Participants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group.
RESULTS


We found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
CONCLUSIONS


Our results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking.
IMPLICATIONS


These findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.",2020,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
",['Participants (n=1250) were adult smokers from ten U.S. sites randomized to one of three groups'],"['nicotine per gram of tobacco [mg/g]), immediate nicotine reduction', 'gradual nicotine reduction', 'standard nicotine content cigarettes']",['cigarette consumption'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}]",,0.010842,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kypriotakis', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""Al'absi"", 'Affiliation': 'Department of Family Medicine and BioBehavioral Health, University of Minnesota Medical School, Duluth, MN.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Leischow', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lori G', 'Initials': 'LG', 'LastName': 'Strayer', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz209']
159,32320144,Weight Change 2 Years After Termination of the Intensive Lifestyle Intervention in the Look AHEAD Study.,"OBJECTIVE


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


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


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


Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.",2020,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","['participants with overweight/obesity and type 2 diabetes', 'Two years after the end of the intervention (EOI), ILI and DSE participants', 'Weight Change 2 Years']","['ILI and DSE', '10-year intensive lifestyle intervention (ILI', 'Intensive Lifestyle Intervention']","['cardiovascular morbidity and mortality', 'EOI weight', 'gain weight', 'weight-control behaviors']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}]",,0.0402555,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Division of Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bolin', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Ewing', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Gay', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Department of Integrative Physiology and Metabolism, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Michalski', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reboussin', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redmon', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinburg', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22769']
160,31732867,"Comparison of analgesic effect, knee joint function recovery, and safety profiles between pre-operative and post-operative administrations of meloxicam in knee osteoarthritis patients who underwent total knee arthroplasty.","AIMS


This study aimed to compare the efficacy and safety of pre-operative and post-operative meloxicam administration regarding post-operative pain control and knee joint function recovery in knee osteoarthritis (KOA) patients who underwent total knee arthroplasty (TKA).
METHODS


Totally, 196 KOA patients who underwent TKA were consecutively enrolled and randomly assigned into pre-operative (N = 98) and post-operative administration group (N = 98) as 1:1 ratio. Pre-operative administration group received meloxicam 15 mg at 24 h pre-operation and 7.5 mg at 4 h, 24 h, 48 h, and 72 h post-operation, respectively. Post-operative administration group received meloxicam 15 mg at 4 h post-operation and 7.5 mg at 24 h, 48 h, and 72 h post-operation, respectively. Pain visual analog scale (VAS) at rest and at flexion, patient's global assessment (PGA), patient-controlled analgesia (PCA) consumption, hospital for special surgery (HSS), knee score, and adverse events were assessed.
RESULTS


Pre-operative meloxicam administration attenuated pain VAS score at rest at 6 h, 12 h, and 24 h; and pain VAS score at flexion at 6 h, 12 h, 24 h, and 48 h; as well as PGA score at 6 h, 12 h, 48 h post-TKA compared with post-operative meloxicam administration. Additional and total consumption of PCA were both decreased in pre-operative meloxicam administration group than post-operative meloxicam administration group, while HSS knee score at 3 months post-TKA was similar between pre-operative and post-operative meloxicam administration groups. Regarding safety, the incidence of adverse events was of no difference between the two groups.
CONCLUSION


Pre-operative administration of meloxicam might assist the post-operative pain management and care in KOA patients who underwent TKA.",2020,"Additional and total consumption of PCA were both decreased in pre-operative meloxicam administration group than post-operative meloxicam administration group, while HSS knee score at 3 months post-TKA was similar between pre-operative and post-operative meloxicam administration groups.","['KOA patients who underwent TKA', '196 KOA patients who underwent TKA', 'knee osteoarthritis patients who underwent total knee arthroplasty', 'knee osteoarthritis (KOA) patients who underwent total knee arthroplasty (TKA']","['meloxicam', 'pre-operative and post-operative meloxicam']","['pain VAS score', 'HSS knee score', 'PGA score', ""Pain visual analog scale (VAS) at rest and at flexion, patient's global assessment (PGA), patient-controlled analgesia (PCA) consumption, hospital for special surgery (HSS), knee score, and adverse events"", 'efficacy and safety', 'total consumption of PCA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]",,0.0369399,"Additional and total consumption of PCA were both decreased in pre-operative meloxicam administration group than post-operative meloxicam administration group, while HSS knee score at 3 months post-TKA was similar between pre-operative and post-operative meloxicam administration groups.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Department of Orthopedics and Traumatology, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, 8 Zhongnan West Road, Wuxi, 214071, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory, Kunshan Hospital Affiliated to Nanjing University of Chinese Medicine, Kunshan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Orthopedics and Traumatology, Changzhou Hospital Affiliated to Nanjing University of Chinese Medicine, Changzhou, China.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics and Traumatology, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, 8 Zhongnan West Road, Wuxi, 214071, China.'}, {'ForeName': 'Shanfu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics and Traumatology, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, 8 Zhongnan West Road, Wuxi, 214071, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics and Traumatology, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, 8 Zhongnan West Road, Wuxi, 214071, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics and Traumatology, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, 8 Zhongnan West Road, Wuxi, 214071, China. jing07214480@163.com.'}]",Irish journal of medical science,['10.1007/s11845-019-02128-y']
161,32229523,Accelerated partner therapy (APT) partner notification for people with  Chlamydia trachomatis : protocol for the Limiting Undetected Sexually Transmitted infections to RedUce Morbidity (LUSTRUM) APT cross-over cluster randomised controlled trial.,"INTRODUCTION


Partner notification (PN) is a process aiming to identify, test and treat the sex partners of people (index patients) with sexually transmitted infections (STIs). Accelerated partner therapy (APT) is a PN method whereby healthcare professionals assess sex partners, by telephone consultation, before giving the index patient antibiotics and STI self-sampling kits to deliver to their sex partner(s). The Limiting Undetected Sexually Transmitted infections to RedUce Morbidity programme aims to determine the effectiveness of APT in heterosexual women and men with chlamydia and determine whether APT could affect  Chlamydia trachomatis  transmission at population level.
METHODS AND ANALYSIS


This protocol describes a cross-over cluster randomised controlled trial of APT, offered as an additional PN method, compared with standard PN. The trial is accompanied by an economic evaluation, transmission dynamic modelling and a qualitative process evaluation involving patients, partners and healthcare professionals. Clusters are 17 sexual health clinics in areas of England and Scotland with contrasting patient demographics. We will recruit 5440 heterosexual women and men with chlamydia, aged ≥16 years.The primary outcome is the proportion of index patients testing positive for  C. trachomatis  12-16 weeks after the PN consultation. Secondary outcomes include: proportion of sex partners treated; cost effectiveness; model-predicted chlamydia prevalence; experiences of APT.The primary outcome analysis will be by intention-to-treat, fitting random effects logistic regression models that account for clustering of index patients within clinics and trial periods. The transmission dynamic model will be used to predict change in chlamydia prevalence following APT. The economic evaluation will use mathematical modelling outputs, taking a health service perspective. Qualitative data will be analysed using interpretative phenomenological analysis and framework analysis.
ETHICS AND DISSEMINATION


This protocol received ethical approval from London-Chelsea Research Ethics Committee (18/LO/0773). Findings will be published with open access licences.
TRIAL REGISTRATION NUMBER


ISRCTN15996256.",2020,The primary outcome is the proportion of index patients testing positive for  C. trachomatis  12-16 weeks after the PN consultation.,"['people with  Chlamydia trachomatis ', 'heterosexual women and men with chlamydia', '5440 heterosexual women and men with chlamydia, aged ≥16 years', 'patients, partners and healthcare professionals', '17 sexual health clinics in areas of England and Scotland with contrasting patient demographics', 'sex partners of people (index patients) with sexually transmitted infections (STIs']","['Accelerated partner therapy (APT', 'Partner notification (PN', 'Accelerated partner therapy (APT) partner notification']","['proportion of index patients testing positive for  C. trachomatis', ' proportion of sex partners treated; cost effectiveness; model-predicted chlamydia prevalence; experiences']","[{'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036916', 'cui_str': 'STDs'}]","[{'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0079990', 'cui_str': 'Notification, Partner'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",5440.0,0.217124,The primary outcome is the proportion of index patients testing positive for  C. trachomatis  12-16 weeks after the PN consultation.,"[{'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Estcourt', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK claudia.estcourt@gcu.ac.uk.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Howarth', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Low', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Mapp', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Melvina', 'Initials': 'M', 'LastName': 'Woode Owusu', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Flowers', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Wayal', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Symonds', 'Affiliation': 'Western Sussex Hospitals NHS Foundation Trust, Worthing, West Sussex, UK.'}, {'ForeName': 'Rak', 'Initials': 'R', 'LastName': 'Nandwani', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saunders', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pothoulaki', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Althaus', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pickering', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'McKinnon', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Brice', 'Affiliation': 'All East Sexual Health, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Comer', 'Affiliation': 'All East Sexual Health, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tostevin', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Chidubem Duby', 'Initials': 'CD', 'LastName': 'Ogwulu', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Vojt', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Jackie A', 'Initials': 'JA', 'LastName': 'Cassell', 'Affiliation': 'Brighton and Sussex Medical School, East Sussex, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034806']
162,32234747,Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol.,"INTRODUCTION


Rates of mental health illnesses and burnout are increasing internationally. Therapeutic yoga is increasingly used to improve and maintain physical, mental and emotional well-being and general health. This protocol describes a study to evaluate the effectiveness of an existing primary care group-based therapeutic yoga programme, the Yoga of Stress Resilience programme, which combines yoga and psychotherapeutic techniques, in improving mental health and decreasing burnout. Implementation factors will also be evaluated for potential scale-up.
METHODS AND ANALYSIS


A pragmatic before-after interventional trial design will be used to study changes in occupational participation and mental health outcomes, including anxiety, depression, burnout, functional impairment, insomnia, perceived stress, loneliness, self-compassion and readiness for change in adults experiencing anxiety and burnout. Repeated measures analysis of variance will be used to determine changes in outcome measures over time. Regression and multivariate analyses will be conducted to examine relationships between participant characteristics and outcomes and among various outcomes. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework will be used to guide the analyses.
ETHICS AND DISSEMINATION


Approval from the Hamilton Integrated Research Ethics Board has been waived: project number 7082 (full review waived). Informed consent will be obtained prior to enrolling any participant into the study. All data will be kept confidential. Peer-reviewed publications and presentations will target researchers and health professionals.
TRIAL REGISTRATION NUMBER


The ClinicalTrials.gov registry (NCT03973216).",2020,"This protocol describes a study to evaluate the effectiveness of an existing primary care group-based therapeutic yoga programme, the Yoga of Stress Resilience programme, which combines yoga and psychotherapeutic techniques, in improving mental health and decreasing burnout.",['adults experiencing anxiety and burnout'],"['existing primary care group-based therapeutic yoga programme, the Yoga of Stress Resilience programme', 'group-based Yoga of Stress Resilience programme']","['occupational participation and mental health outcomes, including anxiety, depression, burnout, functional impairment, insomnia, perceived stress, loneliness, self-compassion and readiness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",,0.0567754,"This protocol describes a study to evaluate the effectiveness of an existing primary care group-based therapeutic yoga programme, the Yoga of Stress Resilience programme, which combines yoga and psychotherapeutic techniques, in improving mental health and decreasing burnout.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alvarez', 'Affiliation': 'Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada alvare@mcmaster.ca.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Sutton', 'Affiliation': 'Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Bria', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': ""Ontario Network of Sexual Assault /Domestic Violence Treatment Centres, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Shailla', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': 'Clairhurst Medical Centre, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-035862']
163,32326304,A Pilot Randomised Clinical Trial of a Novel Approach to Reduce Sedentary Behaviour in Care Home Residents: Feasibility and Preliminary Effects of the GET READY Study.,"Care-home residents are among the most sedentary and least active of the population. We aimed to assess the feasibility, acceptability, safety, and preliminary effects of an intervention to reduce sedentary behaviour (SB) co-created with care home residents, staff, family members, and policymakers within a pilot two-armed pragmatic cluster randomized clinical trial (RCT). Four care homes from two European countries participated, and were randomly assigned to control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-to-one with the care home resident and a family member. A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old). GR involves six face to face sessions over a 12-week period with goal-oriented prompts for movement throughout. The feasibility and acceptability of the intervention were assessed and adverse events (AEs) were collected. The preliminary effects of the GR on SB, quality of life, fear of falling, and physical function were assessed. Means and standard deviations are presented, with the mean change from baseline to post-intervention calculated along with 95% confidence intervals. The CG smoked more, sat more, and had more functional movement difficulties than the GR at baseline. The GR intervention was feasible and acceptable to residents and staff. No AEs occurred during the intervention. GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT. The co-created GR was shown to be feasible and acceptable, with no AEs.",2020,"GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT.","['Sedentary Behaviour in Care Home Residents', 'Four care homes from two European countries participated', 'A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old']","['control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-to-one with the care home resident and a family member', 'GR intervention']","['sedentary behaviour (SB', 'daily hours spent sitting/lying', 'feasibility, acceptability, safety', 'SB, quality of life, fear of falling, and physical function', 'functional movement difficulties', 'daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",31.0,0.0546158,"GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giné-Garriga', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Philippa M', 'Initials': 'PM', 'LastName': 'Dall', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Sandlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Jerez-Roig', 'Affiliation': 'Research Group on Methodology, Methods, Models and Outcome of Health and Social Sciences (M3O), Faculty of Health Sciences and Welfare, University of Vic-Central University of Catalonia (UVIC-UCC), 08500 Vic, Spain.'}, {'ForeName': 'Sebastien F M', 'Initials': 'SFM', 'LastName': 'Chastin', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17082866']
164,32229541,Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial.,"RATIONALE


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


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


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


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


PTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.  Trial registration number  ClinicalTrials.gov (NCT02667171), 28 January 2016.",2020,PTR was not superior to conventional PR on the 6MWD and we found no differences between groups.,"['134 participants (74 females, mean±SD\u2009age 68±9 years, FEV 1  33%±9% predicted, 6MWD 327±103 metres', 'severe COPD', 'people with COPD', 'patients with COPD and FEV 1  <50% eligible for routine hospital-based, outpatient PR']","['PTR intervention', 'conventional PR', 'Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation', 'PTR']","['change in 6MWD', 'respiratory symptoms, quality of life, physical activity and lower limb muscle function', '6MWD']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",,0.234033,PTR was not superior to conventional PR on the 6MWD and we found no differences between groups.,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark henrik.hansen.09@regionh.dk.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical and Occupational Therapy, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jon Torgny', 'Initials': 'JT', 'LastName': 'Wilcke', 'Affiliation': 'Department of Pulmonary Medicine, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Lisbeth Marie', 'Initials': 'LM', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Frost Andeassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød Hospital, Hillerød, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'Department of Public Health, University of Copenhagen Faculty of Health Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Nina Skavlan', 'Initials': 'NS', 'LastName': 'Godtfredsen', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}]",Thorax,['10.1136/thoraxjnl-2019-214246']
165,31732852,Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial.,"PURPOSE


The aim of this study is to investigate the effect of an edible saliva substitute, oral moisturizing jelly (OMJ), and a topical saliva gel (GC) on dry mouth, swallowing ability, and nutritional status in post-radiotherapy head and neck cancer patients.
METHODS


Sixty-two post-radiation head and neck cancer patients with xerostomia completed a blinded randomized controlled trial. They were advised to swallow OMJ (n = 31) or apply GC orally (n = 31) for 2 months. Outcome measures were assessed at baseline, 1, and 2 months, including subjective and objective dry mouth (Challcombe) scores, subjective swallowing problem scores (EAT-10), water swallowing time, clinical nutritional status (PG-SGA), body weight, and dietary intake.
RESULTS


After 1 and 2 months of interventions, subjective and objective dry mouth scores, subjective swallowing problem scores, swallowing times, and clinical nutritional status in both groups were significantly improved (p < 0.0001). Compared to GC, OMJ group had higher percent improvement in all outcome measures (p < 0.001) except swallowing time and clinical nutritional status. Interestingly, subjective dry mouth scores were significantly correlated with subjective swallowing problem scores (r = 0.5321, p < 0.0001).
CONCLUSIONS


Continuous uses of saliva substitutes (OMJ or GC) for at least a month improved signs and symptoms of dry mouth and enhanced swallowing ability. An edible saliva substitute was superior to a topical saliva gel for alleviating dry mouth and swallow problems. These lead to improved clinical nutritional status. Thus, palliation of dry mouth may be critical to support nutrition of post-radiotherapy head and neck cancer patients.
CLINICAL TRIAL REGISTRY


Clinicaltrials.gov NCT03035825.",2020,"Compared to GC, OMJ group had higher percent improvement in all outcome measures (p < 0.001) except swallowing time and clinical nutritional status.","['Sixty-two post-radiation head and neck cancer patients with xerostomia', 'post-radiotherapy head and neck cancer patients']","['saliva substitutes', 'topical saliva gel (GC', 'saliva substitutes (OMJ or GC', 'GC, OMJ', 'swallow OMJ', 'edible saliva substitute, oral moisturizing jelly (OMJ']","['signs and symptoms of dry mouth and enhanced swallowing ability', 'swallowing ability and clinical nutritional status', 'dry mouth, swallowing ability, and nutritional status', 'subjective swallowing problem scores', 'subjective and objective dry mouth scores, subjective swallowing problem scores, swallowing times, and clinical nutritional status', 'subjective and objective dry mouth (Challcombe) scores, subjective swallowing problem scores (EAT-10), water swallowing time, clinical nutritional status (PG-SGA), body weight, and dietary intake', 'swallowing time and clinical nutritional status', 'subjective dry mouth scores']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0445177', 'cui_str': 'Post-radiation (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0453543', 'cui_str': 'Jello'}]","[{'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0392678', 'cui_str': 'Swallowing problem (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",62.0,0.0521118,"Compared to GC, OMJ group had higher percent improvement in all outcome measures (p < 0.001) except swallowing time and clinical nutritional status.","[{'ForeName': 'Sumalee', 'Initials': 'S', 'LastName': 'Nuchit', 'Affiliation': 'Master of Science Program in Nutrition and Dietetics, Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Aroonwan', 'Initials': 'A', 'LastName': 'Lam-Ubol', 'Affiliation': 'Faculty of Dentistry, Srinakarinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Wannaporn', 'Initials': 'W', 'LastName': 'Paemuang', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sineepat', 'Initials': 'S', 'LastName': 'Talungchit', 'Affiliation': 'Faculty of Dentistry, Srinakarinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Orapin', 'Initials': 'O', 'LastName': 'Chokchaitam', 'Affiliation': 'Department of Dental Service, Chonburi Cancer Hospital, Chonburi, Thailand.'}, {'ForeName': 'On-Ong', 'Initials': 'OO', 'LastName': 'Mungkung', 'Affiliation': 'Department of Dental Service, Chonburi Cancer Hospital, Chonburi, Thailand.'}, {'ForeName': 'Tippawan', 'Initials': 'T', 'LastName': 'Pongcharoen', 'Affiliation': 'Institute of Nutrition, Mahidol University, 999 Phutthamonthon Sai 4 Road, Salaya, Nakhon Pathom, 73170, Thailand.'}, {'ForeName': 'Dunyaporn', 'Initials': 'D', 'LastName': 'Trachootham', 'Affiliation': 'Institute of Nutrition, Mahidol University, 999 Phutthamonthon Sai 4 Road, Salaya, Nakhon Pathom, 73170, Thailand. dunyaporn.tra@mahidol.ac.th.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05132-1']
166,31911261,Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT).,"Approximately 5% of patients with sarcoidosis have clinically manifest cardiac involvement. Clinical features of Cardiac Sarcoidosis are dependent on the location, extent, and activity of the disease. First line therapy is usually with prednisone and this is recommended based on clinician experience, expert opinion and small observational cohorts. There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions. Corticosteroid are associated with multiple adverse effects including hypertension, diabetes, weight gain, osteoporosis, and increased risk of infections. In contrast Methotrexate is generally well tolerated and is increasingly used in other forms of sarcoidosis.
OBJECTIVES


The Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS-RCT; NCT03593759) is a multicenter randomized controlled trial designed to evaluate the optimal initial treatment strategy for patients with active cardiac sarcoidosis. We hypothesize that (1) a low dose prednisone/methotrexate combination will have non-inferior efficacy to standard dose prednisone and that (2) the low dose prednisone/ methotrexate combination will result in significantly better quality of life than standard dose prednisone, as a result of reduced burden of side effects.
METHODS/DESIGN


Eligible study subjects will have active clinically manifest cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease, significant sinus node dysfunction, non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction or right ventricular dysfunction. Subjects will be randomized in a 1:1 ratio to prednisone 0.5 mg/kg/day for 6 months (maximum dose 30 mg daily) OR to prednisone 20 mg daily for 1 month, then 10 mg daily for 1 month, then 5 mg daily for one month then stop AND methotrexate 15-20 mg once weekly for 6 months. The primary endpoint is summed perfusion rest score on 6-month PET (blinded core-lab review). The summed perfusion rest score is measure of myocardial fibrosis/scar. The design is non-inferiority with a sample size of 97 per group.
DISCUSSION


Given the multiorgan system potential adverse side effects of prednisone, proving noninferiority of an alternate regimen would be sufficient to make the alternative compare favorably to standard dose steroids. This is the first ever clinical trial in cardiac sarcoidosis and thus in addition to the listed goals of the trial, we will also establish a multi-center, multinational cardiac sarcoidosis clinical trials network. Such a collaborative infrastructure will enable a new era of high quality data to guide physicians when treating cardiac sarcoidosis patients.",2020,There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions.,"['Eligible study subjects will have active clinically manifest cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease, significant sinus node dysfunction, non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction or right ventricular dysfunction', 'patients with active cardiac sarcoidosis']","['Corticosteroid', 'prednisone/methotrexate', 'prednisone', 'Methotrexate']","['hypertension, diabetes, weight gain, osteoporosis, and increased risk of infections', 'quality of life', 'summed perfusion rest score on 6-month PET (blinded core-lab review']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C0392077', 'cui_str': 'Cardiac sarcoidosis (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0428908', 'cui_str': 'Sinus Node Disease'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia (disorder)'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C0242707', 'cui_str': 'Right Ventricular Dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0034380'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.150713,There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Birnie', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada. Electronic address: dbirnie@ottawaheart.ca.'}, {'ForeName': 'Rob S B', 'Initials': 'RSB', 'LastName': 'Beanlands', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Nery', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Aaron', 'Affiliation': 'University of Ottawa, ON, Canada.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'DeKemp', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Lorne', 'Initials': 'L', 'LastName': 'Gula', 'Affiliation': 'London Health Sciences Centre, On, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Hamilton Health Sciences Center, ON, Canada.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Judson', 'Affiliation': 'Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Juneau', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Department of Radiology and Nuclear Medicine, Montréal, QC, Canada.""}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan; Libin Cardiovascular Institute of Alberta, Alberta, Canada.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Quinn', 'Affiliation': 'Montreal Heart Institute, Quebec, Canada.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Rivard', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Toma', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Varnava', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wickremasinghe', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Kron', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}]",American heart journal,['10.1016/j.ahj.2019.10.003']
167,32203691,"Efficacy of levetiracetam, fosphenytoin, and valproate for established status epilepticus by age group (ESETT): a double-blind, responsive-adaptive, randomised controlled trial.","BACKGROUND


Benzodiazepine-refractory, or established, status epilepticus is thought to be of similar pathophysiology in children and adults, but differences in underlying aetiology and pharmacodynamics might differentially affect response to therapy. In the Established Status Epilepticus Treatment Trial (ESETT) we compared the efficacy and safety of levetiracetam, fosphenytoin, and valproate in established status epilepticus, and here we describe our results after extending enrolment in children to compare outcomes in three age groups.
METHODS


In this multicentre, double-blind, response-adaptive, randomised controlled trial, we recruited patients from 58 hospital emergency departments across the USA. Patients were eligible for inclusion if they were aged 2 years or older, had been treated for a generalised convulsive seizure of longer than 5 min duration with adequate doses of benzodiazepines, and continued to have persistent or recurrent convulsions in the emergency department for at least 5 min and no more than 30 min after the last dose of benzodiazepine. Patients were randomly assigned in a response-adaptive manner, using Bayesian methods and stratified by age group (<18 years, 18-65 years, and >65 years), to levetiracetam, fosphenytoin, or valproate. All patients, investigators, study staff, and pharmacists were masked to treatment allocation. The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion. The primary safety outcome was life-threatening hypotension or cardiac arrhythmia. The efficacy and safety outcomes were analysed by intention to treat. This study is registered in ClinicalTrials.gov, NCT01960075.
FINDINGS


Between Nov 3, 2015, and Dec 29, 2018, we enrolled 478 patients and 462 unique patients were included: 225 children (aged <18 years), 186 adults (18-65 years), and 51 older adults (>65 years). 175 (38%) patients were randomly assigned to levetiracetam, 142 (31%) to fosphenyltoin, and 145 (31%) were to valproate. Baseline characteristics were balanced across treatments within age groups. The primary efficacy outcome was met in those treated with levetiracetam for 52% (95% credible interval 41-62) of children, 44% (33-55) of adults, and 37% (19-59) of older adults; with fosphenytoin in 49% (38-61) of children, 46% (34-59) of adults, and 35% (17-59) of older adults; and with valproate in 52% (41-63) of children, 46% (34-58) of adults, and 47% (25-70) of older adults. No differences were detected in efficacy or primary safety outcome by drug within each age group. With the exception of endotracheal intubation in children, secondary safety outcomes did not significantly differ by drug within each age group.
INTERPRETATION


Children, adults, and older adults with established status epilepticus respond similarly to levetiracetam, fosphenytoin, and valproate, with treatment success in approximately half of patients. Any of the three drugs can be considered as a potential first-choice, second-line drug for benzodiazepine-refractory status epilepticus.
FUNDING


National Institute of Neurological Disorders and Stroke, National Institutes of Health.",2020,The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion.,"['for 52% (95% credible interval 41-62) of children, 44% (33-55) of adults, and 37% (19-59) of older adults; with fosphenytoin in 49% (38-61) of children, 46% (34-59) of adults, and 35% (17-59) of older adults; and with valproate in 52% (41-63) of children, 46% (34-58) of adults, and 47% (25-70) of older adults', 'recruited patients from 58 hospital emergency departments across the USA', 'Children, adults, and older adults with established status epilepticus respond similarly to', 'Between Nov 3, 2015, and Dec 29, 2018, we enrolled 478 patients and 462 unique patients were included: 225 children (aged <18 years), 186 adults (18-65 years), and 51 older adults (>65 years', 'Patients were eligible for inclusion if they were aged 2 years or older, had been treated for a generalised convulsive seizure of longer than 5 min duration with adequate doses of benzodiazepines, and continued to have persistent or recurrent convulsions in the emergency department for at least 5 min and no more than 30 min after the last dose of']","['levetiracetam', 'levetiracetam, fosphenytoin, or valproate', 'levetiracetam, fosphenytoin, and valproate', 'benzodiazepine', 'valproate']","['efficacy and safety', 'life-threatening hypotension or cardiac arrhythmia', 'absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication', 'efficacy and safety outcomes']","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1869075', 'cui_str': 'Convulsions (SMQ)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",478.0,0.634583,The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion.,"[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Kapur', 'Affiliation': 'Department of Neurology, University of Virginia Health Sciences Center, Charlottesville, VA, USA.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Neurology, Pediatrics and Epidemiology and Population Health Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Holsti', 'Affiliation': 'Division of Pediatric Emergency Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Babcock', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA; Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, Neuro Emergencies Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cloyd', 'Affiliation': 'Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Bleck', 'Affiliation': 'Division of Stroke and Neurocritical Care, Northwestern University Feinberg School of Medicine, Chicago, IL USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health Neuroscience Center, Bethesda, MD, USA.'}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Meinzer', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cock', 'Affiliation': ""Institute of Molecular and Clinical Sciences, St George's University of London, London, UK.""}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Fountain', 'Affiliation': 'Department of Neurology, University of Virginia Health Sciences Center, Charlottesville, VA, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Underwood', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': 'ConfluenceStat LLC and University of Central Florida College of Medicine, Cooper City, FL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, Neuro Emergencies Research, University of Michigan, Ann Arbor, MI, USA. Electronic address: robert.silbergleit@umich.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30611-5']
168,32323190,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the prevention of venous thromboembolism.,"Anticoagulant plasma concentrations and patient characteristics might affect the benefit-risk balance of therapy. The study objective was to assess the impact of model-predicted rivaroxaban exposure and patient characteristics on outcomes in patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery. Post hoc exposure-response analyses were conducted using data from the phase 3 RECORD1-4 studies, in which 12,729 patients were randomized to rivaroxaban 10 mg once daily or enoxaparin for ≤ 39 days. Multivariate regression approaches were used to correlate model-predicted individual rivaroxaban exposures and patient characteristics with outcomes. In the absence of measured rivaroxaban exposure, exposure estimates were predicted based on individual increases in prothrombin time (PT) and by making use of the known correlation between rivaroxaban plasma concentration and dynamics of PT. No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified. A significant association between exposure and a composite of major or non-major clinically relevant (NMCR) bleeding from day 4 after surgery was observed. The relationship was shallow, with an approximate predicted absolute increase in a composite of major or NMCR bleeding from 1.08 [95% confidence interval (CI) 0.76-1.54] to 2.18% (95% CI 1.51-3.17) at the 5th and 95th percentiles of trough plasma concentration, respectively. In conclusion, based on the underlying data and analysis, no reliable target window for exposure with improved benefit-risk could be identified within the investigated exposure range. Hence, monitoring rivaroxaban levels is unlikely to be beneficial in VTE-P.",2020,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"['12,729 patients', 'patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery']","['rivaroxaban', 'rivaroxaban 10\xa0mg once daily or enoxaparin']","['composite of major or NMCR bleeding', 'prothrombin time (PT', 'rivaroxaban exposure and total VTE or major bleeding', 'composite of major or non-major clinically relevant (NMCR) bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",12729.0,0.076615,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Reinecke', 'Affiliation': 'Bayer AB, Solna, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University, and the Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mueck', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA. scott.berkowitz@bayer.com.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02078-8']
169,32320401,"Febuxostat does not delay progression of carotid atherosclerosis in patients with asymptomatic hyperuricemia: A randomized, controlled trial.","BACKGROUND


An elevated level of serum uric acid (SUA) is associated with an increased risk of cardiovascular disease. Pharmacological intervention with urate-lowering agents, such as the conventional purine analogue xanthine oxidase (XO) inhibitor, allopurinol, has been used widely for a long period of time in clinical practice to reduce SUA levels. Febuxostat, a novel non-purine selective inhibitor of XO, has higher potency for inhibition of XO activity and greater urate-lowering efficacy than conventional allopurinol. However, clinical evidence regarding the effects of febuxostat on atherosclerosis is lacking. The purpose of the study was to test whether treatment with febuxostat delays carotid intima-media thickness (IMT) progression in patients with asymptomatic hyperuricemia.
METHODS AND FINDINGS


The study was a multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial undertaken at 48 sites throughout Japan between May 2014 and August 2018. Adults with both asymptomatic hyperuricemia (SUA >7.0 mg/dL) and maximum IMT of the common carotid artery (CCA) ≥1.1 mm at screening were allocated equally using a central web system to receive either dose-titrated febuxostat (10-60 mg daily) or as a control-arm, non-pharmacological lifestyle modification for hyperuricemia, such as a healthy diet and exercise therapy. Of the 514 enrolled participants, 31 were excluded from the analysis, with the remaining 483 people (mean age 69.1 years [standard deviation 10.4 years], female 19.7%) included in the primary analysis (febuxostat group, 239; control group, 244), based on a modified intention-to-treat principal. The carotid IMT images were recorded by a single sonographer at each site and read in a treatment-blinded manner by a single analyzer at a central core laboratory. The primary endpoint was the percentage change from baseline to 24 months in mean IMT of the CCA, determined by analysis of covariance using the allocation adjustment factors (age, gender, history of type 2 diabetes, baseline SUA, and baseline maximum IMT of the CCA) as the covariates. Key secondary endpoints included changes in other carotid ultrasonographic parameters and SUA and the incidence of clinical events. The mean values (± standard deviation) of CCA-IMT were 0.825 mm ± 0.173 mm in the febuxostat group and 0.832 mm ± 0.175 mm in the control group (mean between-group difference [febuxostat - control], -0.007 mm [95% confidence interval (CI) -0.039 mm to 0.024 mm; P = 0.65]) at baseline; 0.832 mm ± 0.182 mm in the febuxostat group and 0.848 mm ± 0.176 mm in the control group (mean between-group difference, -0.016 mm [95% CI -0.051 mm to 0.019 mm; P = 0.37]) at 24 months. Compared with the control group, febuxostat had no significant effect on the primary endpoint (mean percentage change 1.2% [95% CI -0.6% to 3.0%] in the febuxostat group (n = 207) versus 1.4% [95% CI -0.5% to 3.3%] in the control group (n = 193); mean between-group difference, -0.2% [95% CI -2.3% to 1.9%; P = 0.83]). Febuxostat also had no effect on the other carotid ultrasonographic parameters. The mean baseline values of SUA were comparable between the two groups (febuxostat, 7.76 mg/dL ± 0.98 mg/dL versus control, 7.73 mg/dL ± 1.04 mg/dL; mean between-group difference, 0.03 mg/dL [95% CI -0.15 mg/dL to 0.21 mg/dL; P = 0.75]). The mean value of SUA at 24 months was significantly lower in the febuxostat group than in the control group (febuxostat, 4.66 mg/dL ± 1.27 mg/dL versus control, 7.28 mg/dL ± 1.27 mg/dL; mean between-group difference, -2.62 mg/dL [95% CI -2.86 mg/dL to -2.38 mg/dL; P < 0.001]). Episodes of gout arthritis occurred only in the control group (4 patients [1.6%]). There were three deaths in the febuxostat group and seven in the control group during follow-up. A limitation of the study was the study design, as it was not a placebo-controlled trial, had a relatively small sample size and a short intervention period, and only enrolled Japanese patients with asymptomatic hyperuricemia.
CONCLUSIONS


In Japanese patients with asymptomatic hyperuricemia, 24 months of febuxostat treatment did not delay carotid atherosclerosis progression, compared with non-pharmacological care. These findings do not support the use of febuxostat for delaying carotid atherosclerosis in this population.
TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trial Registry UMIN000012911.",2020,"The mean value of SUA at 24 months was significantly lower in the febuxostat group than in the control group (febuxostat, 4.66 mg/dL ± 1.27 mg/dL versus control, 7.28 mg/dL ± 1.27 mg/dL; mean between-group difference, -2.62 mg/","['Adults with both asymptomatic hyperuricemia (SUA >7.0 mg/dL) and maximum IMT of the common carotid artery (CCA) ≥1.1 mm at screening', 'enrolled Japanese patients with asymptomatic hyperuricemia', 'Japanese patients with asymptomatic hyperuricemia, 24 months of', '48 sites throughout Japan between May 2014 and August 2018', '514 enrolled participants, 31 were excluded from the analysis, with the remaining 483 people (mean age 69.1 years [standard deviation 10.4 years], female 19.7%) included in the primary analysis (febuxostat group, 239; control group, 244), based on a modified intention-to-treat principal', 'patients with asymptomatic hyperuricemia']","['febuxostat delays carotid intima-media thickness (IMT) progression', 'Febuxostat', 'febuxostat', 'Pharmacological intervention with urate-lowering agents, such as the conventional purine analogue xanthine oxidase (XO) inhibitor, allopurinol', 'placebo', 'febuxostat (10-60 mg daily) or as a control-arm, non-pharmacological lifestyle modification for hyperuricemia, such as a healthy diet and exercise therapy', 'dL', 'conventional allopurinol']","['carotid ultrasonographic parameters', 'delay carotid atherosclerosis progression', 'changes in other carotid ultrasonographic parameters and SUA and the incidence of clinical events', 'carotid IMT images', 'mean values (± standard deviation) of CCA-IMT', 'mean value of SUA', 'Episodes of gout arthritis', 'percentage change from baseline to 24 months in mean IMT of the CCA, determined by analysis of covariance using the allocation adjustment factors (age, gender, history of type 2 diabetes, baseline SUA, and baseline maximum IMT of the CCA', 'mean baseline values of SUA', 'carotid atherosclerosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348944', 'cui_str': 'Hyperuricemia without signs of inflammatory arthritis and tophaceous disease'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1268902', 'cui_str': 'Purine analog'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0003868', 'cui_str': 'Gouty arthropathy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",514.0,0.180376,"The mean value of SUA at 24 months was significantly lower in the febuxostat group than in the control group (febuxostat, 4.66 mg/dL ± 1.27 mg/dL versus control, 7.28 mg/dL ± 1.27 mg/dL; mean between-group difference, -2.62 mg/","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Teragawa', 'Affiliation': 'Department of Cardiovascular Medicine, JR Hiroshima Hospital, Hiroshima, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Ishizaka', 'Affiliation': 'Department of Cardiology, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kanzaki', 'Affiliation': 'Department of Cardiology, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': 'Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sezai', 'Affiliation': 'The Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Eguchi', 'Affiliation': 'Department of Internal Medicine, Hanyu General Hospital, Hanyu, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Clinical Research, National Hospital Organization, Tochigi Medical Center, Utsunomiya, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University, Mibu, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Ishibashi', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Kimitsu Chuo Hospital, Kisarazu, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ishizu', 'Affiliation': 'Department of Clinical Laboratory Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Maemura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yukihito', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Ohishi', 'Affiliation': 'Department of Cardiovascular Medical and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Oyama', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003095']
170,31863094,Residual Adrenal Function in Autoimmune Addison's Disease-Effect of Dual Therapy With Rituximab and Depot Tetracosactide.,"CONTEXT


In autoimmune Addison's disease (AAD), exogenous glucocorticoid (GC) therapy is an imperfect substitute for physiological GC secretion. Patients on long-term steroid replacement have increased morbidity, reduced life expectancy, and poorer quality of life.
OBJECTIVE


The objective of this article is to restore adrenocortical steroidogenic function in recent-onset AAD.
DESIGN


An open-label, multicenter trial of immunotherapy and trophic stimulation in new-onset AAD was conducted. Serial measurement of serum and urine corticosteroids at baseline and throughout a 72-week follow-up period was performed.
SETTING


This study was conducted at the.
endocrine departments and clinical research facilities at 5 UK tertiary centers.
PATIENTS


Thirteen participants (9 female, 4 male; age 19-64 years) were included with AAD confirmed by high adrenocorticotropin, low circulating cortisol (basal < 100 nmol/L or post-tetracosactide < 300 nmol/L), and positive serum 21-hydroxylase antibodies.
INTERVENTION


All participants received dual therapy with B-lymphocyte-depleting immunotherapy (rituximab 1 g given twice) and repeated depot tetracosactide (1 mg on alternate days for 12 weeks).
MAIN OUTCOME MEASURE


Restoration of normal GC secretion (stimulated cortisol > 550 nmol/L) at week 48 was the main outcome measure.
RESULTS


Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry. Following intervention, 7 of 13 (54%) had an increase in stimulated cortisol measurement, with a peak response of 325 nmol/L at week 18 in 1 participant. Increased steroid metabolites, assayed by urine gas chromatography-mass spectrometry at week 12 and week 48, was detected in 8 of 13 (62%) individuals, reflecting an increase in endogenous steroidogenesis. Four of 13 had residual adrenal function at 72 weeks.
CONCLUSION


Combined treatment with rituximab and depot tetracosactide did not restore normal adrenal function. Nevertheless, adrenocortical plasticity is demonstrated in some patients, and this has the potential to be exploited to improve adrenal function.",2020,Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry.,"['Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry', 'endocrine departments and clinical research facilities at 5 UK tertiary centers', 'Thirteen participants (9 female, 4 male; age 19-64 years) were included with AAD confirmed by high adrenocorticotropin, low circulating cortisol (basal < 100 nmol/L or post-tetracosactide < 300 nmol/L), and positive serum 21-hydroxylase antibodies']","['Rituximab and Depot Tetracosactide', 'glucocorticoid (GC) therapy', 'immunotherapy and trophic stimulation', 'dual therapy with B-lymphocyte-depleting immunotherapy (rituximab 1 g given twice) and repeated depot tetracosactide', 'rituximab and depot tetracosactide']","['endogenous steroidogenesis', 'Restoration of normal GC secretion (stimulated cortisol > 550 nmol/L', 'morbidity, reduced life expectancy, and poorer quality of life', 'stimulated cortisol measurement', 'residual adrenal function', 'normal adrenal function', 'Increased steroid metabolites, assayed by urine gas chromatography-mass spectrometry']","[{'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0804954', 'cui_str': 'Steroid 21-monooxygenase antibody'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0034380'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0024868', 'cui_str': 'Spectrum Analysis, Mass-Gas Chromatography'}]",,0.0287794,Ten of 13 (77%) participants had detectable stimulated serum cortisol (26-265 nmol/L) at trial entry.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Napier', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Earn H', 'Initials': 'EH', 'LastName': 'Gan', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Mitchell', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Lorna C', 'Initials': 'LC', 'LastName': 'Gilligan', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'D Aled', 'Initials': 'DA', 'LastName': 'Rees', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Moran', 'Affiliation': ""University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Chatterjee', 'Affiliation': ""University of Cambridge Metabolic Research Laboratories, Wellcome Trust-MRC, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Bijay', 'Initials': 'B', 'LastName': 'Vaidya', 'Affiliation': 'Royal Devon & Exeter Hospital, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'James', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Yaasir', 'Initials': 'Y', 'LastName': 'Mamoojee', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ashwell', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Arlt', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Simon H S', 'Initials': 'SHS', 'LastName': 'Pearce', 'Affiliation': 'Institute of Genetic Medicine, International Centre for Life, Newcastle University, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz287']
171,30768419,"Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial.","OBJECTIVE


This pragmatic, randomized, non-inferiority trial compared the effectiveness and cost of group-based parent management training with mastery-based individual coaching parent management training in a low-income, predominantly African American sample.
METHOD


Parents seeking treatment for their 2- to 5-year-old children's behavior problems in an urban fee-for-service child mental health clinic were randomized to the Chicago Parent Program (CPP; n = 81) or Parent-Child Interaction Therapy (PCIT; n = 80). Consent followed clinic intake and diagnostic assessment and parent management training was delivered by clinicians employed at the clinic. Primary outcome measures were externalizing child behavior problems, assessed at baseline and postintervention follow-up, using the Child Behavior Checklist (CBCL) and average per-participant treatment cost.
RESULTS


Data from 158 parents were analyzed. Most were mothers (75.9%), African American (70.3%), and economically disadvantaged (98.7% Medicaid insured). Of children, 58.2% were boys, and mean age was 3.6 years (SD 1.03). Based on CBCL scores, behavior problems improved in the 2 conditions (Cohen d = 0.57 for CPP and 0.50 for PCIT). CPP was not inferior to PCIT (90% CI -1.58 to 4.22) at follow-up, even after controlling for differences in treatment length (90% CI -1.63 to 4.87). Average per-participant treatment cost was higher for PCIT (mean $2,151) than for CPP (mean $1,413, 95% CI -1,304 to -170).
CONCLUSION


For parents of young children living in urban poverty, CPP is not inferior to PCIT for decreasing child behavior problems. CPP requires less time to complete and costs a third less than PCIT.
CLINICAL TRIAL REGISTRATION INFORMATION


Early Parenting Intervention Comparison (EPIC); https://clinicaltrials.gov/; NCT01517867.",2019,"CPP was not inferior to PCIT (90% CI -1.58 to 4.22) at follow-up, even after controlling for differences in treatment length (90% CI -1.63 to 4.87).","['Urban Mental Health Clinic', ""Parents seeking treatment for their 2- to 5-year-old children's behavior problems in an urban fee-for-service child mental health clinic"", 'Data from 158 parents were analyzed', 'a low-income, predominantly African American sample', 'Most were mothers (75.9%), African American (70.3%), and economically disadvantaged (98.7% Medicaid insured', 'Of children, 58.2% were boys, and mean age was 3.6 years (SD 1.03']","['CPP', 'group-based parent management training with mastery-based individual coaching parent management training', 'Chicago Parent Program (CPP; n\xa0= 81) or Parent-Child Interaction Therapy (PCIT', 'Early Parenting Intervention Comparison (EPIC']","['externalizing child behavior problems, assessed at baseline and postintervention follow-up, using the Child Behavior Checklist (CBCL) and average per-participant treatment cost', 'CBCL scores, behavior problems', 'Average per-participant treatment cost']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",158.0,0.142358,"CPP was not inferior to PCIT (90% CI -1.58 to 4.22) at follow-up, even after controlling for differences in treatment length (90% CI -1.63 to 4.87).","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Gross', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD. Electronic address: debgross@jhu.edu.'}, {'ForeName': 'Harolyn M E', 'Initials': 'HME', 'LastName': 'Belcher', 'Affiliation': 'Kennedy-Krieger Institute, Baltimore.'}, {'ForeName': 'Chakra', 'Initials': 'C', 'LastName': 'Budhathoki', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}, {'ForeName': 'Mirian E', 'Initials': 'ME', 'LastName': 'Ofonedu', 'Affiliation': 'Kennedy-Krieger Institute; Maryland Center for Developmental Disabilities, Windsor Mill.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Dutrow', 'Affiliation': 'Kennedy-Krieger Institute, Baltimore.'}, {'ForeName': 'Melissa Kurtz', 'Initials': 'MK', 'LastName': 'Uveges', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Slade', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD; University of Maryland School of Medicine, Baltimore; US Department of Veteran Affairs VISN5 MIRECC, Baltimore.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.08.013']
172,32321161,Evenly Distributed Protein Intake over 3 Meals Augments Resistance Exercise-Induced Muscle Hypertrophy in Healthy Young Men.,"BACKGROUND


Although daily protein intake (PI) has been reported to be essential for regulating muscle mass, the distribution of daily PI in individuals is typically the lowest at breakfast and skewed toward dinner. Skewed protein intake patterns and inadequate PI at breakfast were reported to be negative factors for muscle maintenance.
OBJECTIVES


This study examined whether a protein-enriched meal at breakfast is more effective for muscle accretion compared with the typical skewed PI pattern.
METHODS


This 12-wk, parallel-group, randomized clinical trial included 26 men (means ± SEs; age: 20.8 ± 0.4 y; BMI: 21.8 ± 0.4 kg/m2). The ""high breakfast"" (HBR) group (n = 12) consumed a protein-enriched meal at breakfast providing a PI of 0.33 g/kg body weight (BW); their PI at lunch (0.46 g/kg BW) and dinner (0.48 g/kg BW) provided an adequate overall daily PI (1.30 g/kg BW/d). The ""low breakfast"" (LBR) group (n = 14) consumed 0.12 g protein/kg BW at breakfast; intakes at lunch (0.45 g/kg BW) and dinner (0.83 g/kg BW) yielded the same daily PI as in the HBR group. The participants performed supervised resistance training (RT) 3 times per week (75-80% 1-repetition maximum; 3 sets × 10 repetitions). DXA was used to measure the primary outcome variable, that is, total lean soft tissue mass (LTM).
RESULTS


The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups. After the intervention, increases in total LTM were significant in both groups, with that in the HBR group (2.5 ± 0.3 kg) tending to be greater than that in the LBR group (1.8 ± 0.3 kg) (P = 0.06), with a large effect size (Cohen d = 0.795).
CONCLUSIONS


For RT-induced muscle hypertrophy in healthy young men, consuming a protein-enriched meal at breakfast and less protein at dinner while achieving an adequate overall PI is more effective than consuming more protein at dinner.This study was registered at University hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000037583 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042763).",2020,The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups.,"['Healthy Young Men', '26 men (means\xa0±\xa0SEs; age: 20.8\xa0±\xa00.4 y; BMI: 21.8\xa0±\xa00.4\xa0kg/m2', 'healthy young men', 'registered at University hospital Medical Information Network (UMIN']","['protein-enriched meal at breakfast', 'DXA', 'low breakfast"" (LBR', 'Evenly Distributed Protein Intake over 3 Meals Augments Resistance Exercise-Induced Muscle Hypertrophy', 'supervised resistance training (RT', 'high breakfast"" (HBR']","['total LTM', 'total lean soft tissue mass (LTM']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}]",26.0,0.0519553,The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yasuda', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Tomita', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Arimitsu', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}]",The Journal of nutrition,['10.1093/jn/nxaa101']
173,32319685,Bringing new plasma donors back: testing the efficacy of telephone and e-mail communications with first-time donors.,"BACKGROUND


As demand for plasma-derived products grows, retention of voluntary nonremunerated plasmapheresis donors is crucial for many blood collection agencies. Currently, there is limited evidence of how to encourage first-time plasmapheresis donors to return and establish a high-frequency donation routine. This study tested the effectiveness of an intervention designed to increase retention of first-time plasmapheresis donors, increase donation frequency, and reduce time to return.
STUDY DESIGN AND METHODS


A total of 6788 first-time plasmapheresis donors were randomly assigned to one of four conditions. Donors received an alternative e-mail or the business-as-usual control e-mail paired or not with a phone call. Outcomes were compared to the control e-mail in intention-to-treat analyses.
RESULTS


Compared with control, donors in all intervention conditions were more likely to donate plasma as their first return donation in 6 months; however, there were no significant differences between intervention conditions. Rates of plasma donation in the alternative e-mail, control e-mail plus call, and alternative e-mail plus call conditions were 17.0, 15.0, and 18.0% higher than control. While the extra donations obtained in the alternative e-mail condition were cost neutral, the cost of one additional donation in the call conditions ranged from 20.14-20.89 AUD (13.08-13.56 USD).
CONCLUSION


Communications specifically designed to encourage first-time plasmapheresis donors to view regular plasmapheresis donations as ""easy""; to forward-book more than one appointment; and to provide education about plasma are effective in encouraging donors to return to plasma, to donate more frequently, and to return faster.",2020,"Rates of plasma donation in the alternative e-mail, control e-mail plus call, and alternative e-mail plus call conditions were 17.0, 15.0, and 18.0% higher than control.",['A total of 6788 first-time plasmapheresis donors'],"['telephone and e-mail communications with first-time donors', 'alternative e-mail or the business-as-usual control e-mail paired or not with a phone call']","['Rates of plasma donation', 'donation frequency, and reduce time to return']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032134', 'cui_str': 'Plasmapheresis'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",6788.0,0.0159038,"Rates of plasma donation in the alternative e-mail, control e-mail plus call, and alternative e-mail plus call conditions were 17.0, 15.0, and 18.0% higher than control.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thorpe', 'Affiliation': 'Australian Red Cross Blood Service Donor Research Team, Melbourne, Victoria, Australia.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Masser', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': 'Australian Red Cross Blood Service Donor Research Team, Melbourne, Victoria, Australia.'}, {'ForeName': 'Carley N', 'Initials': 'CN', 'LastName': 'Gemelli', 'Affiliation': 'Australian Red Cross Blood Service Donor Research Team, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tanya E', 'Initials': 'TE', 'LastName': 'Davison', 'Affiliation': 'Australian Red Cross Blood Service Donor Research Team, Melbourne, Victoria, Australia.'}]",Transfusion,['10.1111/trf.15787']
174,32270927,Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study.,"OBJECTIVE


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


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


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


In the setting of a randomized trial, TRE presents a simplified view of food intake that reduces weight.",2020,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","['Participants (17 women and 3 men; mean [SD]: 45.5 [12.1] years; BMI 34.1 [7.5] kg/m 2  ) with a prolonged eating window (15.4 [0.9] hours', 'Humans with Overweight']","['TRE', 'TRE (n\u2009=\u200911: 8-hour window, unrestricted eating within window) versus non-TRE']","['reduced weight', 'weight loss, alters body composition, and improves metabolic measures', 'visceral fat', 'number of eating occasions, weight, lean mass, and visceral fat', 'number of eating occasions', 'fat mass', 'Body Composition and Metabolic Measures', 'Weight, body composition (dual x-ray absorptiometry), lipids, blood pressure, 2-hour oral glucose tolerance, 2-week continuous glucose monitoring, and 2-week physical activity (actigraphy assessed', 'lean mass', 'eating window', 'Physical activity and metabolic measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]",17.0,0.0340305,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","[{'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Chow', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Emily N C', 'Initials': 'ENC', 'LastName': 'Manoogian', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Alvear', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Fleischer', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Honoree', 'Initials': 'H', 'LastName': 'Thor', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Dietsche', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hodges', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Esch', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Malaeb', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Tasma', 'Initials': 'T', 'LastName': 'Harindhanavudhi', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Mashek', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22756']
175,32275024,A randomized control trial to compare thoracic epidural with intercostal block plus intravenous morphine infusion for postoperative analgesia in patients undergoing elective thoracotomy.,"Objective


The objective of the study is to compare the efficacy of Thoracic epidural with Intercostal block plus intravenous morphine infusion for postoperative analgesia in patients undergoing elective thoracotomy.
Methodology and Design


This study is designed as a prospective randomized clinical trial. Setting: Christian Medical College Hospital, Vellore, India.
Participants


Patients undergoing elective thoracic surgery through posterolateral thoracotomy.
Intervention


In Group A (TEA) patients epidural catheter was inserted at T5-6 level before induction of GA and analgesia was activated using 0.25% of bupivacaine towards the end of the surgery, before chest closure and infusion of 0.1% bupivacaine with 2 mcg/ml of fentanyl was started. In Group B (ICN) patients, an intercostal blockade of the 5 intercostal spaces was performed by the surgeon just before chest closure using 0.25% bupivacaine and a continuous intravenous morphine infusion of 0.015-0.02 mg/kg/hr was started.
Measurements


Assessment of resting and dynamic pain intensity using Numerical rating scale and sedation using Ramsay sedation scale was done and recorded at 1, 6,12,18,24 hours during the first postoperative day. The other parameters that were measured include side effects and the requirement of rescue analgesia. Results: Resting and Dynamic (NRS) pain scores were less in Group A (TEA) than Group B (ICN). In the first 12 hours, the differences in both the resting (P = 0.0505) and dynamic (P = 0.0307) pain scores were statistically significant. By the end of the first postoperative day, sedation scores were more or less similar in both groups. The incidence of side effects and requirement of rescue analgesia were found to be similar in both the groups.
Conclusion


To summarize, though the results show a slightly better quality of analgesia with the thoracic epidural, the difference being clinically insignificant intercostal blockade could be considered as a valid alternative.",2020,Resting and Dynamic (NRS) pain scores were less in Group A (TEA) than Group B (ICN).,"['Participants\n\n\nPatients undergoing', 'patients undergoing elective thoracotomy']","['morphine', 'bupivacaine', 'elective thoracic surgery through posterolateral thoracotomy', 'bupivacaine with 2 mcg/ml of fentanyl', 'thoracic epidural with intercostal block plus intravenous morphine infusion', 'Thoracic epidural with Intercostal block plus intravenous morphine infusion']","['sedation scores', 'side effects and the requirement of rescue analgesia', 'side effects and requirement of rescue analgesia', 'resting and dynamic pain intensity using Numerical rating scale and sedation using Ramsay sedation scale', 'Resting and Dynamic (NRS) pain scores', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0442951', 'cui_str': 'Posterolateral thoracotomy'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0601189,Resting and Dynamic (NRS) pain scores were less in Group A (TEA) than Group B (ICN).,"[{'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Vilvanathan', 'Affiliation': 'Department of Cardiothoracic Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences, Trivandrum, Kerala, India.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Kuppuswamy', 'Affiliation': 'Department of Anaesthesiology, Christian Medical College Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sahajanandan', 'Affiliation': 'Department of Anaesthesiology, Christian Medical College Hospital, Vellore, Tamil Nadu, India.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_167_18']
176,32275025,Cardioprotective effects of propofol-dexmedetomidine in open-heart surgery: A prospective double-blind study.,"Background


Myocardial protection in cardiac surgeries is a must and requires multimodal approaches in perioperative period to decrease and prevent the increase of myocardial oxygen demand and consumption that lead to postoperative cardiac complications including myocardial ischemia, dysfunction, and heart failure.
Study Design


Prospective, controlled, randomized, double-blinded study.
Aims


This study aims to study the effect of propofol-dexmedetomidine continuous infusion cardioprotection during open-heart surgery in adult patients.
Materials and Methods


Sixty adult patients of both sexes aged from 30 to 60 years old belonging to the American Society of Anesthesiologists III or IV undergoing open-heart surgery were randomly divided into two equal groups: Group P (control group) received continuous infusion of propofol at a rate of 2 mg/kg/h and 50 cc 0.9% sodium chloride solution infused at a rate of 0.4 μg/kg/h (used as a placebo) and Group PD received continuous infusion of propofol at a rate of 2 mg/kg/h and dexmedetomidine 200 μg diluted in 50 cc 0.9% sodium chloride solution infused at a rate of 0.4 μg/kg/h. Infusion for all patients started immediately preoperative till skin closure. Hemodynamic measurements of heart rate (HR), invasive mean arterial pressure, and oxygen saturation were recorded at baseline before induction of anesthesia, immediately after intubation, at skin incision, at sternotomy and every 15 min in the 1 st  h then every 30 min during the prebypass period then every 15 min in the 1 st  h then every 30 min after weaning from CPB till the end of the surgery. Serum biomarkers; cardiac troponin (cTnI) and creatine kinase-myocardial bound (CK-MB) samples were measured basally (T1), 15 min after unclamping of the aorta (T2), immediate postoperative (T3), and 24 h postoperative (T4). Intraoperative data were also recorded including the number of coronary grafts, aortic cross-clamping duration, duration of cardiopulmonary bypass (CPB), duration of surgery, and rhythm of reperfusion. Fentanyl requirement, extubation time, and length of intensive care unit (ICU) stay were also recorded for every case.
Results


There was no statistically significant differences as regard to demographic data between the studied two groups. HR and blood pressure recorded was lower in the PD group than the control group, and this difference was noted to be statistically significant. Furthermore, the PD group showed lower levels of myocardial enzymes (cTnI and CK-MB), decreased total fentanyl requirement, earlier postoperative extubation, and shorter ICU stay than the P(control) group.
Conclusion


The use of propofol-dexmedetomidine in CPB surgeries offers more cardioprotective effects than the use of propofol alone.",2020,"Furthermore, the PD group showed lower levels of myocardial enzymes (cTnI and CK-MB), decreased total fentanyl requirement, earlier postoperative extubation, and shorter ICU stay than the P(control) group.
","['Sixty adult patients of both sexes aged from 30 to 60 years old belonging to the American Society of Anesthesiologists III or IV undergoing open-heart surgery', 'open-heart surgery', 'adult patients']","['Group P (control group) received continuous infusion of propofol at a rate of 2 mg/kg/h and 50 cc 0.9% sodium chloride solution', 'propofol', 'placebo', 'propofol-dexmedetomidine', 'propofol-dexmedetomidine continuous infusion cardioprotection', 'dexmedetomidine 200 μg diluted in 50 cc 0.9% sodium chloride solution']","['HR and blood pressure', 'Cardioprotective effects', 'Fentanyl requirement, extubation time, and length of intensive care unit (ICU) stay', 'levels of myocardial enzymes (cTnI and CK-MB), decreased total fentanyl requirement, earlier postoperative extubation, and shorter ICU stay', 'Hemodynamic measurements of heart rate (HR), invasive mean arterial pressure, and oxygen saturation', 'number of coronary grafts, aortic cross-clamping duration, duration of cardiopulmonary bypass (CPB), duration of surgery, and rhythm of reperfusion', 'Serum biomarkers; cardiac troponin (cTnI) and creatine kinase-myocardial bound (CK-MB) samples']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0204901', 'cui_str': 'Hemodynamic measurements'}, {'cui': 'C0428888', 'cui_str': 'Invasive mean arterial pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",60.0,0.0962379,"Furthermore, the PD group showed lower levels of myocardial enzymes (cTnI and CK-MB), decreased total fentanyl requirement, earlier postoperative extubation, and shorter ICU stay than the P(control) group.
","[{'ForeName': 'Ahmed Said', 'Initials': 'AS', 'LastName': 'Elgebaly', 'Affiliation': 'Department of Anesthesia and PSICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Sameh Mohamad', 'Initials': 'SM', 'LastName': 'Fathy', 'Affiliation': 'Department of Anesthesia and PSICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ayman Ahmed', 'Initials': 'AA', 'LastName': 'Sallam', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Elbarbary', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_168_18']
177,32131611,Activated Platelets Induce Endothelial Cell Inflammatory Response in Psoriasis via COX-1.,"OBJECTIVE


Patients with psoriasis have impaired vascular health and increased cardiovascular disease (CVD). Platelets are key players in the pathogenesis of vascular dysfunction in cardiovascular disease and represent therapeutic targets in cardiovascular prevention. The object of this study was to define the platelet phenotype and effector cell properties on vascular health in psoriasis and evaluate whether aspirin modulates the platelet-induced phenotype. Approach and Results: Platelets from psoriasis patients (n=45) exhibited increased platelet activation (relative to age- and gender-matched controls, n=18), which correlated with psoriasis skin severity. Isolated platelets from psoriasis patients demonstrated a 2- to 3-fold ( P <0.01) increased adhesion to human aortic endothelial cells and induced proinflammatory transcriptional changes, including upregulation of  IL 8  (interleukin 8),  IL1β , and Cox (cyclooxygenase)-2 Platelet RNA sequencing revealed an interferon signature and elevated expression of  COX-1 , which correlated with psoriasis disease severity ( r =0.83,  P =0.01). In a randomized trial of patients with psoriasis, 2 weeks of 81 mg low-dose aspirin, a COX-1 inhibitor, reduced serum thromboxane (Tx) B 2  and reduced brachial vein endothelial proinflammatory transcript expression >70% compared with the no-treatment group ( P <0.01). Improvement in brachial vein endothelial cell inflammation significantly correlated with change in serum TxB 2  ( r =0.48,  P =0.02).
CONCLUSIONS


In patients with psoriasis, platelets are activated and induce endothelial cell inflammation. Low-dose aspirin improved endothelial cell health in psoriasis via platelet COX-1 inhibition. These data demonstrate a previously unappreciated role of platelets in psoriasis and endothelial cell inflammation and suggests that aspirin may be effective in improving vascular health in patients with psoriasis. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03228017.",2020,(Tx) B 2  and reduced brachial vein endothelial proinflammatory transcript expression >70% compared with the no-treatment group ( P <0.01).,"['psoriasis patients (n=45', 'Patients with psoriasis have impaired vascular health and increased cardiovascular disease (CVD', 'Psoriasis Via COX-1 (Cyclooxygenase-2', 'patients with psoriasis']","['aspirin', 'Low-dose aspirin', 'aspirin, a COX-1 inhibitor, reduced serum thromboxane']","['adhesion to human aortic endothelial cells and induced proinflammatory transcriptional changes, including upregulation of  IL 8  (interleukin 8),  IL1β , and  COX-2  (cyclooxygenase-2', 'endothelial cell health', 'vascular health', 'psoriasis skin severity', 'Tx) B 2  and reduced brachial vein endothelial proinflammatory transcript expression', 'platelet activation', 'psoriasis disease severity', 'interferon signature and elevated expression of  COX-1', 'brachial vein endothelial cell inflammation']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}]","[{'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0045550', 'cui_str': 'sodium 2,5-dichloro-4-bromophenol'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0226812', 'cui_str': 'Structure of brachial vein'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0576413,(Tx) B 2  and reduced brachial vein endothelial proinflammatory transcript expression >70% compared with the no-treatment group ( P <0.01).,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Garshick', 'Affiliation': 'From the Department of Medicine, Center for the Prevention of Cardiovascular Disease (M.S.G., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tawil', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Tessa J', 'Initials': 'TJ', 'LastName': 'Barrett', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Charissa M', 'Initials': 'CM', 'LastName': 'Salud-Gnilo', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York (C.M.S.-G, J.G.K.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eppler', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Jose U', 'Initials': 'JU', 'LastName': 'Scher', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Psoriatic Arthritis Center (J.U.S.), New York University School of Medicine.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Neimann', 'Affiliation': 'Ronald O. Perelman Department of Dermatology (A.L.N.), New York University School of Medicine.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Jelic', 'Affiliation': 'Division of Pulmonary, Allergy & Critical Care Medicine, Department of Medicine, Columbia University Medical Center, New York (S.J.).'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD (N.N.M.).'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Medicine, Center for the Prevention of Cardiovascular Disease (M.S.G., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York (C.M.S.-G, J.G.K.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'From the Department of Medicine, Center for the Prevention of Cardiovascular Disease (M.S.G., E.A.F., J.S.B.), New York University School of Medicine.'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.119.314008']
178,32144895,"Baseline Habitual Physical Activity Predicts Weight Loss, Weight Compensation, and Energy Intake During Aerobic Exercise.","OBJECTIVE


This study aimed to determine whether different measures of habitual physical activity (PA) at baseline predict weight change, weight compensation, and changes in energy intake (EI) during a 24-week supervised aerobic exercise intervention.
METHODS


Data from 108 participants (78 women; 48.7 [SD: 11.6] years; BMI 31.4 [SD: 4.6] kg/m 2  ), randomly assigned to either the moderate-dose exercise group (8 kcal/kg of body weight per week) or the high-dose exercise group (20 kcal/kg of body weight per week) of the Examination of Mechanisms of Exercise-induced Weight Compensation (E-MECHANIC) trial, were analyzed. Moderate-to-vigorous PA (MVPA), steps per day, and PA energy expenditure (PAEE) were measured with SenseWear armbands (BodyMedia, Pittsburgh, Pennsylvania), and total activity energy expenditure and EI were estimated with doubly labeled water, all over 2 weeks, before and toward the end of the intervention. Multiple linear regression models, adjusted for sex, exercise group, and baseline value of the outcome, were used.
RESULTS


Baseline habitual MVPA levels predicted weight change (β = -0.275; P = 0.020), weight compensation (β = -0.238; P = 0.043), and change in EI (β = -0.318; P = 0.001). Associations between baseline PAEE and outcomes were comparable, whereas steps per day and, importantly, total activity energy expenditure (via doubly labeled water) did not significantly predict change in weight-related outcomes.
CONCLUSIONS


While acknowledging substantial variability in the data, on average, lower baseline habitual MVPA and PAEE levels were associated with less weight loss from exercise, higher compensation, and increased EI.",2020,"RESULTS


Baseline habitual MVPA levels predicted weight change (β = -0.275; P = 0.020), weight compensation (β ",['Data from 108 participants (78 women; 48.7 [SD: 11.6] years; BMI\xa031.4'],['supervised aerobic exercise intervention'],"['Moderate-to-vigorous PA (MVPA), steps per day, and PA energy expenditure (PAEE', 'habitual physical activity (PA', 'baseline habitual MVPA and PAEE levels', 'total activity energy expenditure', 'weight loss from exercise, higher compensation, and increased EI', 'weight compensation (β', 'SenseWear armbands (BodyMedia, Pittsburgh, Pennsylvania), and total activity energy expenditure and EI', 'Baseline Habitual Physical Activity Predicts Weight Loss, Weight Compensation, and Energy Intake', 'weight change, weight compensation, and changes in energy intake (EI']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",108.0,0.0856458,"RESULTS


Baseline habitual MVPA levels predicted weight change (β = -0.275; P = 0.020), weight compensation (β ","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Höchsmann', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22766']
179,32229520,Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs.,"INTRODUCTION


Although shortcomings in clinician-family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution.
METHODS AND ANALYSIS


This is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4-6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians' workflow. The primary outcome is surrogates' ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants.
ETHICS AND DISSEMINATION


We obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT02445937.",2020,"Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.","['Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians', '690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania']",[],"[""surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation"", ""surrogates' ratings of the quality of communication during the ICU stay""]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0222045'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",,0.0661771,"Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.","[{'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Lincoln', 'Affiliation': 'Department of General Internal Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Shields', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Praewpannarai', 'Initials': 'P', 'LastName': 'Buddadhumaruk', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Chung-Chou H', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Pike', 'Affiliation': 'Department of Neuroscience, Ely Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Hsiangyu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Kozar', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pidro', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Kahn', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Darby', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Donald Wolff Center for Quality Improvement and Innovation, UPMC Health System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Department of General Internal Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA douglas.white@pitt.edu.'}]",BMJ open,['10.1136/bmjopen-2019-033521']
180,31559532,Clinical and MRI efficacy of sc IFN β-1a tiw in patients with relapsing MS appearing to transition to secondary progressive MS: post hoc analyses of PRISMS and SPECTRIMS.,"This study evaluated efficacy of subcutaneous (sc) interferon beta-1a (IFN β-1a) 44 µg 3 × weekly (tiw) in patients appearing to transition from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive MS (SPMS). The PRISMS study included 560 patients with RRMS (EDSS 0-5.0; ≥ 2 relapses in previous 2 years), and the SPECTRIMS study included 618 patients with SPMS (EDSS 3.0-6.5 and ≥ 1-point increase in previous 2 years [≥ 0.5 point if 6.0-6.5]) randomly assigned to sc IFN β-1a 44 or 22 µg or placebo for 2-3 years, respectively. These post hoc analyses examined five subgroups of MS patients with EDSS 4.0-6.0: PRISMS (n = 59), PRISMS/SPECTRIMS (n = 335), PRISMS/SPECTRIMS with baseline disease activity (n = 195; patients with either ≥ 1 relapse within 2 years before baseline or ≥ 1 gadolinium-enhancing lesion at baseline), PRISMS/SPECTRIMS without baseline disease activity (n = 140), and PRISMS/SPECTRIMS with disease activity during the study (n = 202). In the PRISMS and PRISMS/SPECTRIMS subgroups, sc IFN β-1a delayed disability progression, although no significant effect was observed in PRISMS/SPECTRIMS subgroups with activity at baseline or activity during the study (regardless of baseline activity). In the PRISMS/SPECTRIMS subgroup, over year 1 (0-1) and 2 (0-2), sc IFN β-1a 44 µg tiw significantly reduced annualized relapse rate (p ≤ 0.001), and relapse risk (p < 0.05) versus placebo. Similar results were seen for the PRISMS/SPECTRIMS with baseline disease activity subgroup. Subcutaneous IFN β-1a reduced T2 burden of disease and active T2 lesions in the PRISMS/SPECTRIMS subgroups overall, with and without baseline activity. In conclusion, these post hoc analyses indicate that effects of sc IFN β-1a 44 µg tiw on clinical/MRI endpoints are preserved in a patient subgroup appearing to transition between RRMS and SPMS.",2020,"Subcutaneous IFN β-1a reduced T2 burden of disease and active T2 lesions in the PRISMS/SPECTRIMS subgroups overall, with and without baseline activity.","['560 patients with RRMS (EDSS 0-5.0;\u2009≥\u20092 relapses in previous 2\xa0years), and the SPECTRIMS study included 618 patients with SPMS (EDSS 3.0-6.5 and\u2009≥\u20091-point increase in previous 2\xa0years [≥\u20090.5 point if 6.0-6.5]) randomly assigned to']","['placebo', 'subcutaneous (sc) interferon beta-1a (IFN β-1a', 'sc IFN β-1a 44 or 22\xa0µg or placebo']","['disability progression', 'annualized relapse rate', 'T2 burden of disease and active T2 lesions', 'relapse risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",618.0,0.040239,"Subcutaneous IFN β-1a reduced T2 burden of disease and active T2 lesions in the PRISMS/SPECTRIMS subgroups overall, with and without baseline activity.","[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada. mfreedman@toh.ca.'}, {'ForeName': 'Staley', 'Initials': 'S', 'LastName': 'Brod', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Singer', 'Affiliation': 'Missouri Baptist Medical Center, St. Louis, MO, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Cohen', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Hayward', 'Affiliation': 'EMD Serono, Inc., Rockland, MA, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Coyle', 'Affiliation': 'Stony Brook University Medical Center, Stony Brook, NY, USA.'}]",Journal of neurology,['10.1007/s00415-019-09532-5']
181,32324700,Protecting the Mental Health of Small-to-Medium Enterprise Owners: A Randomized Control Trial Evaluating a Self-Administered Versus Telephone Supported Intervention.,"OBJECTIVE


Small-medium enterprises (SMEs) are under-represented in occupational health research. Owner/managers face mental ill-health risks/exacerbating factors including financial stress and long hours. This study assessed the effectiveness of a mental health intervention specifically for SME owner/managers.
METHODS


297 owner/managers of SMEs were recruited and invited to complete a baseline survey assessing their mental health and wellbeing and were then randomly allocated to one of three intervention groups: 1) self-administered, 2) self-administered plus telephone, or 3) an active control condition. After a four-month intervention period they were followed up with a second survey.
RESULTS


Intention to treat analyses showed a significant decrease in psychological distress for both the active control and the telephone facilitated intervention groups, with the telephone group demonstrating a greater ratio of change.
CONCLUSION


The provision of telephone support for self-administered interventions in this context appears warranted.",2020,"RESULTS


Intention to treat analyses showed a significant decrease in psychological distress for both the active control and the telephone facilitated intervention groups, with the telephone group demonstrating a greater ratio of change.
",['297\u200aowner/managers of SMEs were recruited and invited to complete a baseline survey assessing their mental health and wellbeing'],"['mental health intervention', 'self-administered, 2) self-administered plus telephone, or 3) an active control condition']",['psychological distress'],"[{'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C2919920', 'cui_str': 'Northern Sami language'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0686994,"RESULTS


Intention to treat analyses showed a significant decrease in psychological distress for both the active control and the telephone facilitated intervention groups, with the telephone group demonstrating a greater ratio of change.
","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Department of University of Tasmania, Australia (Martin, Kilpatrick, Scott, Cocker, Dawkins), Griffith University, Australia (Brough), University of East Anglia, United Kingdom (Sanderson).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kilpatrick', 'Affiliation': ''}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cocker', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dawkins', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Brough', 'Affiliation': ''}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Sanderson', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001882']
182,32324830,"Correction: Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia.",[This corrects the article DOI: 10.1371/journal.pone.0230703.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0230703.].,"['Youth Engaging for Success', 'HIV-positive youth (15-24 years) in Ndola, Zambia']",['clinic-based peer mentoring program'],"['viral suppression, adherence and internalized stigma']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.040727,[This corrects the article DOI: 10.1371/journal.pone.0230703.].,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Denison', 'Affiliation': ''}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Miti', 'Affiliation': ''}, {'ForeName': 'Bareng A S', 'Initials': 'BAS', 'LastName': 'Nonyane', 'Affiliation': ''}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Frimpong', 'Affiliation': ''}, {'ForeName': 'Katherine G', 'Initials': 'KG', 'LastName': 'Merrill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Abrams', 'Affiliation': ''}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Mwansa', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232488']
183,30926955,"Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.","BACKGROUND


Some weight loss medications, including liraglutide 3.0 mg, are thought to facilitate weight loss by improving appetite control. However, no studies have evaluated their long-term appetitive effects.
SUBJECTS/METHODS


This study examined changes in appetite in a subsample of 113 adults with obesity (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) who participated in a 52-week trial. Participants were randomized to intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0 mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). Participants rated their hunger, fullness after meals, liking of meals, and food preoccupation (all as experienced over the past week) using visual analogue scales (0-100 mm). Ratings were completed at baseline and eight subsequent visits over the year.
RESULTS


At week 52, participants treated by IBT-alone lost 6.2 ± 1.6% of baseline weight, compared with 11.8 ± 1.6% and 12.1 ± 1.5% in the IBT-liraglutide and Multi-component groups, respectively. Compared to IBT-alone, IBT-liraglutide participants reported larger reductions at week 6 in hunger (-0.3 ± 4.2 vs -16.8 ± 4.0 mm, p = .005) and food preoccupation (+0.2 ± 3.7 vs -16.3 ± 3.6 mm, p = .002) and larger increases in fullness (-5.1 ± 3.2 vs +9.8 ± 3.0 mm, p = .001). These significant differences persisted at all assessments through week 24. There were no differences between IBT-alone and IBT-liraglutide in meal liking. IBT-alone and Multi-component participants differed in hunger at week 6, and in food preoccupation at all assessments through week 24. Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively. There were no other differences among any groups at week 52.
CONCLUSIONS


Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.",2020,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","['113 adults with obesity (76.1% female, 55.8% white, BMI\u2009=\u200938.8\u2009±\u20094.8\u2009kg/m 2 ) who participated in a 52-week trial']","['intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0\u2009mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'IBT-alone, IBT-liraglutide', 'IBT-alone and Multi-component', 'IBT-liraglutide', 'liraglutide']","['hunger, fullness, and food preoccupation', 'liking of meals relative', 'hunger, fullness after meals, liking of meals, and food preoccupation', 'fullness', 'weight losses', 'food preoccupation', 'appetite', 'visual analogue scales', 'appetite, food preoccupation, and food liking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",113.0,0.0597185,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zayna M', 'Initials': 'ZM', 'LastName': 'Bakizada', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0348-6']
184,30335180,Effectiveness of Village Health Worker-Delivered Smoking Cessation Counseling in Vietnam.,"INTRODUCTION


Smoking prevalence is high in Vietnam, yet tobacco dependence treatment (TDT) is not widely available.
METHODS


We conducted a quasiexperimental study that compared the effectiveness of health care provider advice and assistance (ARM 1) versus ARM 1 plus village health worker (VHW) counseling (ARM 2) on abstinence at 6-month follow-up. This study was embedded in a larger two-arm cluster randomized controlled trial conducted in 26 community health centers (CHCs) in Vietnam. Subjects (N = 1318) were adult patients who visited any participating CHC during the parent randomized controlled trial intervention period and were self-identified as current tobacco users (cigarettes and/or water pipe).
RESULTS


At 6-month follow-up, abstinences rates in ARM 2 were significantly higher than those in ARM 1 (25.7% vs. 10.5%; p < .001). In multivariate analyses, smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR] = 2.96, 95% confidence interval [CI] = 1.78% to 4.92%). Compared to cigarette-only smokers, water pipe-only smokers (AOR = 0.4, 95% CI = 0.26% to 0.62%) and dual users (AOR = 0.62, 95% CI = 0.45% to 0.86%) were less likely to achieve abstinence; however, the addition of VHW counseling (ARM 2) was associated with higher quit rates compared with ARM 1 alone for all smoker types.
CONCLUSION


A team approach in TDT programs that offer a referral system for health care providers to refer smokers to VHW-led cessation counseling is a promising and potentially scalable model for increasing access to evidence-based TDT and increasing quit rates in low middle-income countries (LMICs). TDT programs may need to adapt interventions to improve outcomes for water pipe users.
IMPLICATIONS


The study fills literature gaps on effective models for TDT in LMICs. The addition of VHW-led cessation counseling, available through a referral from primary care providers in CHCs in Vietnam, to health care provider's brief cessation advice, increased 6-month biochemically validated abstinence rates compared to provider advice alone. The study also demonstrated the potential effectiveness of VHW counseling on reducing water pipe use. For LMICs, TDT programs in primary care settings with a referral system to VHW-led cessation counseling might be a promising and potentially scalable model for increasing access to evidence-based treatment.",2019,"In multivariate analyses smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR]=2.96, 95% confidence interval [CI]=1.78-4.92).","['Subjects (N=1,318) were adult patients who visited any participating CHC during the parent RCT intervention period and were self-identified as current tobacco users (cigarettes and/or waterpipe', '26 community health centers (CHCs) in Viet Nam', 'Viet Nam']","['village health worker delivered smoking cessation counseling', 'health care provider advice and assistance (ARM 1) vs. ARM 1 plus village health worker (VHW) counseling (ARM 2']",['quit rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]","[{'cui': 'C0087157', 'cui_str': 'Village Health Workers'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],1318.0,0.0678612,"In multivariate analyses smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR]=2.96, 95% confidence interval [CI]=1.78-4.92).","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health, New York University, New York, NY.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Siman', 'Affiliation': 'Department of Population Health, New York University, New York, NY.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Cleland', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Devanter', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, New York University, New York, NY.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty216']
185,30089792,Ampelopsis grossedentata supplementation effectively ameliorates the glycemic control in patients with type 2 diabetes mellitus.,"BACKGROUND


Some animal and cellular experiments showed that ampelopsis grossedentata (APL) was helpful to improve insulin resistance or glucose uptake.
OBJECTIVE


The aim of this study was to assess the effects of APL on blood glucose metabolism, lipid, and renal function parameters in adults with type 2 diabetes mellitus (T2DM).
METHODS


Eighty participants with T2DM were randomly assigned to the APL group (n = 40, 10 g of APL daily contained 970 mg of dihydromyricetin) or to the placebo group (n = 40, 10 g of APL daily deleted dihydromyricetin) for 1 month in a double-blind, randomized clinical trial. Blood levels of glucose and insulin, lipids, and renal function parameters were assayed.
RESULTS


Seventy subjects completed the trial (36 in the APL group and 34 in the placebo group). The baseline characteristics were similar between the two groups. Compared with the placebo group, the levels of fasting plasma glucose, glycated albumin, cystatin C, and retinol binding protein-4 significantly decreased (all p < 0.05). Meanwhile, the levels of other lipids, apolipoproteins, and other parameters did not change.
CONCLUSIONS


One-month supplementation with APL obviously improved the glycemic control and parameters of renal function in adults with T2DM. Our findings suggested that a potential role for APL in the prevention and treatment of T2DM.",2019,"Compared with the placebo group, the levels of fasting plasma glucose, glycated albumin, cystatin C, and retinol binding protein-4 significantly decreased (all p < 0.05).","['patients with type 2 diabetes mellitus', 'adults with type 2 diabetes mellitus (T2DM', 'Eighty participants with T2DM', 'adults with T2DM', 'Seventy subjects completed the trial (36 in the APL group and 34 in the placebo group']","['APL daily contained 970\u2009mg of dihydromyricetin', 'placebo', 'placebo group (n\u2009=\u200940, 10\u2009g of APL daily deleted dihydromyricetin', 'APL']","['insulin resistance or glucose uptake', 'levels of fasting plasma glucose, glycated albumin, cystatin C, and retinol binding protein-4', 'glycemic control', 'Blood levels of glucose and insulin, lipids, and renal function parameters', 'glycemic control and parameters of renal function', 'blood glucose metabolism, lipid, and renal function parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1174885', 'cui_str': '4H-1-benzopyran-4-one, 2,3-dihydro-3,5,7-trihydroxy-2-(3,4,5-trihydroxyphenyl)-, (2R,3R)-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0061700', 'cui_str': 'glycosylated serum albumin'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",80.0,0.153209,"Compared with the placebo group, the levels of fasting plasma glucose, glycated albumin, cystatin C, and retinol binding protein-4 significantly decreased (all p < 0.05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ran', 'Affiliation': 'Chongqing Medical Nutrition Research Center; Chongqing Key Laboratory of Nutrition and Food Safety; Research Center for Nutrition and Food Safety, Institute of Military Preventive Medicine, Army Medical University, Chongqing, China.'}, {'ForeName': 'XiaoLan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Chongqing Medical Nutrition Research Center; Chongqing Key Laboratory of Nutrition and Food Safety; Research Center for Nutrition and Food Safety, Institute of Military Preventive Medicine, Army Medical University, Chongqing, China.'}, {'ForeName': 'HeDong', 'Initials': 'H', 'LastName': 'Lang', 'Affiliation': 'Chongqing Medical Nutrition Research Center; Chongqing Key Laboratory of Nutrition and Food Safety; Research Center for Nutrition and Food Safety, Institute of Military Preventive Medicine, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Nutrition, XinQiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, XinQiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition, XinQiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'ManTian', 'Initials': 'M', 'LastName': 'Mi', 'Affiliation': 'Chongqing Medical Nutrition Research Center; Chongqing Key Laboratory of Nutrition and Food Safety; Research Center for Nutrition and Food Safety, Institute of Military Preventive Medicine, Army Medical University, Chongqing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Chongqing Medical Nutrition Research Center; Chongqing Key Laboratory of Nutrition and Food Safety; Research Center for Nutrition and Food Safety, Institute of Military Preventive Medicine, Army Medical University, Chongqing, China. yuer_forever@hotmail.com.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0282-z']
186,32320533,First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression.,"OBJECTIVE


Obesity and depression are prevalent and often co-occurring conditions in the United States. The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized trial demonstrated the effectiveness of an integrated intervention for adults with both conditions. Characterizing the intervention's economic effects is important for broader dissemination and implementation.
METHODS


This study evaluated the cost (2018 US dollars) and health-related quality of life (HRQoL) impacts during RAINBOW's first year, comparing intervention (n = 204) and usual-care groups (n = 205). Outcomes included intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes from baseline using Euroqol-5D US utility weights.
RESULTS


RAINBOW's 1-year delivery cost per person was $2,251. Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027). Annual antidepressant medication spending had a larger, nonsignificant increase ($89 [95% CI: -$20 to $197]; P = 0.109). Annual spending on medical care services had a smaller, nonsignificant decrease (-$54 [95% CI: -$832 to $941]; P = 0.905). HRQoL had a nonsignificant increase (0.011 [95% CI: -0.025 to 0.047]; P = 0.546).
CONCLUSIONS


The RAINBOW intervention's economic value will depend on how its 1-year improvements in obesity and depression translate into long-term reduced morbidity, delayed mortality, or averted costs.",2020,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).",['adults with both conditions'],['integrated intervention'],"['Annual spending on medical care services', 'intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0723905,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Prince', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22805']
187,32320537,The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance.,"INTRODUCTION


High-frequency chest wall oscillation (HFCWO) is a commonly prescribed airway clearance technique (ACT) for patients whose ability to expectorate sputum is compromised. This study aimed to assess the effectiveness of a newly developed mobile ACT device (mHFCWO-The Monarch Airway Clearance System) in patients with cystic fibrosis (CF). A standard nonmobile HFCWO device (sHFCWO) was used as a comparator.
METHODOLOGY


This was a randomized, open-label, crossover pilot study. CF patients were treated with each device. Sputum was collected during and after each therapy session, while spirometry tests, Brody score assessment and functional respiratory imaging were performed before and after treatments.
RESULTS


Wet weight of sputum collected during and after treatment was similar for mHFCWO and sHFCWO (6.53 ± 8.55 vs 5.80 ± 5.82; P = .777). Interestingly, the mHFCWO treatment led to a significant decrease in specific airway volume (9.55 ± 9.96 vs 8.74 ± 9.70 mL/L; P < .001), while increasing specific airway resistance (0.10 ± 0.16 vs 0.16 ± 0.23 KPA*S; P < .001). These changes were heterogeneously-distributed throughout the lung tissue and were greater in the distal areas, suggesting a shift of mucus. Changes were accompanied by an overall improvement in the Brody index (57.71 ± 16.55 vs 55.20 ± 16.98; P = .001).
CONCLUSION


The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.",2020,"The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.",['patients with cystic fibrosis (CF'],"['mobile high-frequency chest wall oscillation (HFCWO) device', 'mobile ACT device (mHFCWO-The Monarch Airway Clearance System', 'High-frequency chest wall oscillation (HFCWO', 'standard nonmobile HFCWO device (sHFCWO']","['specific airway resistance', 'specific airway volume', 'Brody index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0447732,"The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.","[{'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Leemans', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Belmans', 'Affiliation': 'Fluidda nv, Kontich, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Van Holsbeke', 'Affiliation': 'Fluidda nv, Kontich, Belgium.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Department of Medical Affairs, Hillrom Company Inc., St. Paul, Minnesota.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Vissers', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Ides', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Verhulst', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Van Hoorenbeeck', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}]",Pediatric pulmonology,['10.1002/ppul.24784']
188,32315330,Effects of hyperoxia on dynamic muscular endurance are associated with individual whole-body endurance capacity.,"Low-intensity training involving high repetitions is recommended to enhance muscular endurance. Hyperoxic conditions could increase the number of repetitions until exhaustion and thereby improve the results of muscular endurance training. This study aimed to investigate the acute effects of hyperoxia on dynamic muscular endurance, and determine individual factors that may be related to these effects. A single-blinded, counterbalanced crossover design was used. Twenty-five young men performed repetitions of the one-arm preacher curl at 30% of their 1-repetition maximum until exhaustion under hyperoxic and normoxic conditions. The maximum number of repetitions was recorded as an index of muscular endurance. Electromyogram (EMG) and near-infrared spectroscopy parameters were measured in the biceps brachii. The maximum number of repetitions was greater (P < 0.001) under hyperoxic conditions (132 ± 59 repetitions) than under normoxic conditions (114 ± 40 repetitions). The root mean square amplitude of EMG and oxygenated hemoglobin concentration for the last five repetitions under normoxic conditions were greater than those under hyperoxic conditions (P = 0.015 and P = 0.003, respectively). The percent change in the maximum number of repetitions between hyperoxic and normoxic conditions had significant positive correlations with individual maximal oxygen uptake measured using an incremental cycle ergometer test (r = 0.562, 95% confidence intervals [CI] = 0.213-0.783, P = 0.003), but not with muscle strength (τ = -0.124, 95% CI = -0.424-0.170, P = 0.387). The 95% CI for the correlation coefficient between the percent change in the maximum number of repetitions and muscular endurance included 0 (τ = 0.284, 95% CI = -0.003-0.565, P = 0.047); this indicated no significant correlation between the two parameters. The results suggest that hyperoxia can acutely enhance dynamic muscular endurance, with delayed elevation of EMG amplitude due to fatigue, and the effects are associated with individual whole-body endurance capacity.",2020,The maximum number of repetitions was greater (P < 0.001) under hyperoxic conditions (132 ± 59 repetitions) than under normoxic conditions (114 ± 40 repetitions).,['Twenty-five young men performed repetitions of the one-arm preacher curl at 30% of their 1-repetition maximum until exhaustion under hyperoxic and normoxic conditions'],['hyperoxia'],"['number of repetitions until exhaustion and thereby improve the results of muscular endurance training', 'muscle strength', 'maximum number of repetitions', 'Electromyogram (EMG) and near-infrared spectroscopy parameters', 'maximum number of repetitions and muscular endurance', 'individual maximal oxygen uptake', 'root mean square amplitude of EMG and oxygenated hemoglobin concentration', 'dynamic muscular endurance']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0242706', 'cui_str': 'Hyperoxia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",25.0,0.110831,The maximum number of repetitions was greater (P < 0.001) under hyperoxic conditions (132 ± 59 repetitions) than under normoxic conditions (114 ± 40 repetitions).,"[{'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Human and Engineered Environmental Studies, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Fukusaki', 'Affiliation': 'Research Center for Total Life Health and Sports Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Naokata', 'Initials': 'N', 'LastName': 'Ishii', 'Affiliation': 'Research Center for Total Life Health and Sports Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan.'}]",PloS one,['10.1371/journal.pone.0231643']
189,32317109,Treatment of Neck Pain With Myofascial Therapies: A Single Blind Randomized Controlled Trial.,"OBJECTIVE


This study aimed to investigate the effects of myofascial release therapy vs a standard physical therapy program in patients with neck pain (NP).
METHODS


This was a randomized controlled trial in which 54 participants with mechanical NP were randomly assigned into an experimental group (EG) or a comparison group (CG). The EG group (n = 27) received 5 therapy sessions of myofascial release therapy while the CG group (n = 27) received 10 sessions of massage, ultrasound therapy, and transcutaneous electric nerve stimulation over a 2-week period. Outcome measures were the numerical pain rating scale (NPRS), pressure pain thresholds (PPTs) and range of motion at the end of treatment and at 1-month follow-up.
RESULTS


At 1-month follow-up, between-group differences in change scores were found in the NPRS (mean = -1.56, 95% confidence interval [CI] [-2.30 to -0.81]; P < .001), in the right thoracic PPT (mean = 0.35, 95% CI [0.03-0.66]; P = .031), and in both left (mean = 0.34, 95% CI [0.08-0.61]; P = .012) and right (mean = 0.29, 95% CI [0.04-0.54]; P = .026) suboccipital PPTs. The success rate was 63.0% in the CG and 92.6% in the EG. The number needed to treat was 3.38 (95% CI = 1.99-11.23).
CONCLUSIONS


Myofascial release therapy could be better than a standard physical therapy program for improving pain and suboccipital PPTs in patients with NP. However, the difference between both treatments is less than the minimum detectable change of the NPRS.",2020,"The number needed to treat was 3.38 (95% CI = 1.99-11.23).
","['patients with NP', 'patients with neck pain (NP', '54 participants with mechanical NP']","['5 therapy sessions of myofascial release therapy while the CG group (n\u202f=\u202f27) received 10 sessions of massage, ultrasound therapy, and transcutaneous electric nerve stimulation', 'standard physical therapy program', 'myofascial release therapy']","['change scores', 'numerical pain rating scale (NPRS), pressure pain thresholds (PPTs) and range of motion at the end of treatment and at 1-month follow-up', 'number needed to treat', 'right thoracic PPT', 'success rate', 'pain and suboccipital PPTs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}]",54.0,0.107912,"The number needed to treat was 3.38 (95% CI = 1.99-11.23).
","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Cádiz, Cádiz, Andalusia, Spain. Electronic address: manuel.rodriguez@uca.es.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodríguez-Almagro', 'Affiliation': 'Department of Health Sciences, University of Jaén, Jaén, Andalusia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Department of Traumatology and Orthopedic Surgery, Jerez de la Frontera Hospital, Jeréz de la Frontera, Andalusia, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Martín-Valero', 'Affiliation': 'Department of Physiotherapy, University of Málaga, Málaga, Andalusia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lomas-Vega', 'Affiliation': 'Department of Health Sciences, University of Jaén, Jaén, Andalusia, Spain.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.12.001']
190,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


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


Medical research center.
METHODS


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


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


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


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


Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3']
191,32326133,A Metabolically Healthy Profile Is a Transient Stage When Exercise and Diet Are Not Supervised: Long-Term Effects in the EXERDIET-HTA Study.,"Metabolically unhealthy obesity (MUO) is a regular state in people with primary hypertension (HTN), obesity, and who are physically inactive. To achieve and maintain a metabolically healthy overweight/obese (MHO) state should be a main treatment goal. The aims of the study were (1) to determine differences in metabolic profiles of overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised aerobic exercise training (SupExT) intervention with an attentional control (AC) group, and (2) to determine whether the changes observed were maintained following six months (6 M) of unsupervised time. Participants (n = 219) were randomly assigned into AC or SupExT groups. All participants underwent a hypocaloric diet. At POST, all participants received diet and physical activity advice for the following 6 M, with no supervision. All measurements were assessed pre-intervention (PRE), POST, and after 6 M. From PRE to POST, MUO participants became MHO with improved ( p  < 0.05) total cholesterol (TC, ∆ = -12.1 mg/dL), alanine aminotransferase (∆ = -8.3 U/L), glucose (∆ = -5.5 mg/dL), C-reactive protein (∆ = -1.4 mg/dL), systolic blood pressure (SBP), and cardiorespiratory fitness (CRF) compared to unhealthy optimal cut-off values. However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p  < 0.05). In a non-physically active population with obesity and HTN, a 16-week SupExT and diet intervention significantly improves cardiometabolic profile from MUO to MHO. However, after 6 M of no supervision, participants returned to MUO. The findings of this study highlight the need for regular, systematic, and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.",2020,"However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p  < 0.05).","['Participants (n = 219', 'metabolically healthy overweight/obese (MHO) state', 'people with primary hypertension (HTN), obesity, and who are physically inactive', 'overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised']","['SupExT and diet intervention', 'Metabolically unhealthy obesity (MUO', 'hypocaloric diet', 'aerobic exercise training (SupExT) intervention with an attentional control (AC']","['systolic blood pressure (SBP), and cardiorespiratory fitness (CRF', 'alanine aminotransferase', 'cardiometabolic profile', 'TC, glucose, and SBP', 'total cholesterol']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",219.0,0.0262249,"However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p  < 0.05).","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Fryer', 'Affiliation': 'School of Sport and Exercise, Oxstalls Campus, University of Gloucestershire, Gloucester GL2 9HW, UK.'}, {'ForeName': 'Aitor Martínez', 'Initials': 'AM', 'LastName': 'Aguirre-Betolaza', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Arratibel-Imaz', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pérez-Asenjo', 'Affiliation': 'Cardiology Unit, Igualatorio Médico Quirúrgico (IMQ-Amárica), 01005 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Francisco-Terreros', 'Affiliation': 'Clinical Trials Unit, Health and Quality of Life Area, TECNALIA, 01009 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Saracho', 'Affiliation': 'Nefrology Department, Osakidetza, Hospital University of Araba, 01009 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082830']
192,31654573,RNA Interference Therapy With ARC-520 Results in Prolonged Hepatitis B Surface Antigen Response in Patients With Chronic Hepatitis B Infection.,"BACKGROUND AND AIMS


ARC-520, the first an RNA interference (RNAi) therapeutic, was designed to reduce all RNA transcripts derived from covalently closed circular DNA, leading to a reduction in viral antigens and hepatitis B virus (HBV) DNA.
APPROACH AND RESULTS


We aimed to evaluate the depth of hepatitis B surface antigen (HBsAg) decline in response to multiple doses of ARC-520 compared to placebo (PBO) in two randomized, multicenter studies in nucleoside/nucleotide analogue reverse-transcriptase inhibitor (NUC)-experienced patients with hepatitis B early antigen (HBeAg)-negative (E-neg) or HBeAg-positive (E-pos) disease. A total of 58 E-neg and 32 E-pos patients were enrolled and received four monthly doses of PBO (n = 20 E-neg, 11 E-pos), 1 mg/kg ARC-520 (n = 17 E-neg, 10 E-pos), or 2 mg/kg ARC-520 (n = 21 E-neg, 11 E-pos) concomitantly with NUC. HBsAg change from baseline to 30 days after the last ARC-520 dose were compared to PBO. Both E-neg and E-pos high-dose groups significantly reduced HBsAg compared to PBO, with mean reductions of 0.38 and 0.54 log IU/mL, respectively. HBsAg reductions persisted for approximately 85 days and >85 days after the last dose in E-neg and E-pos patients, respectively. The low-dose groups did not reach statistical significance in either study. E-pos patients showed a dose-dependent reduction in HBeAg from baseline. Mean maximum reduction was 0.23 and 0.69 log Paul Ehrlich IUs/mL in the low-dose and high dose ARC-520 groups respectively. ARC-520 was well tolerated, with only two serious adverse events of pyrexia possibly related to study drug observed.
CONCLUSIONS


ARC-520 was active in both E-neg and E-pos, NUC-experienced HBV patients; but absolute HBsAg reductions were moderate, possibly due to expression of HBsAg from integrated HBV DNA, indicating the need for RNAi therapeutics that can target viral transcripts regardless of origin.",2020,HBsAg reductions persisted for approximately 85 days and > 85 days after the last dose in E-neg and E-pos patients respectively.,"['Patients with Chronic Hepatitis B Infection', 'A total of 58 E-neg and 32 E-pos patients', 'two randomized, multi-center studies in nucleoside/nucleotide (NUC) experienced patients with hepatitis B e antigen negative (E-neg) or positive (E-pos) disease']","['PBO', 'NUC', 'placebo (PBO', 'ARC-520']","['HBsAg reductions', 'Mean maximum reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}]","[{'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0417582,HBsAg reductions persisted for approximately 85 days and > 85 days after the last dose in E-neg and E-pos patients respectively.,"[{'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ingolf', 'Initials': 'I', 'LastName': 'Schiefke', 'Affiliation': 'Eugastro Gmbh, Leipzig, Germany.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Pusan National University and Medical Research Institute, Busan, Republic of Korea.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Gachon University Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Lik Yuen Chan', 'Affiliation': 'The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Yoon', 'Affiliation': 'Pusan National University Yangsan Hospital, Yangsan-si, Republic of Korea.'}, {'ForeName': 'Hartwig', 'Initials': 'H', 'LastName': 'Klinker', 'Affiliation': 'Universitaetsklinikum Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manns', 'Affiliation': 'Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'IFI Institute at Asklepios Klinik St. Georg, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schluep', 'Affiliation': 'Arrowhead Pharmaceuticals, Inc., Pasadena, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': 'Arrowhead Pharmaceuticals, Inc., Pasadena, CA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Given', 'Affiliation': 'Arrowhead Pharmaceuticals, Inc., Pasadena, CA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Ferrari', 'Affiliation': 'Unit of Infectious Diseases and Hepatology, University of Parma, Parma, Italy.'}, {'ForeName': 'Ching-Lung', 'Initials': 'CL', 'LastName': 'Lai', 'Affiliation': 'Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Locarnini', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory, Melbourne, Australia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Gish', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, Stanford, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31008']
193,32323192,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation.,"Rivaroxaban exposure and patient characteristics may affect the rivaroxaban benefit-risk balance. This study aimed to quantify associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation (NVAF), using data from the phase 3 ROCKET AF trial (NCT00403767). In ROCKET AF, 14,264 patients with NVAF were randomized to rivaroxaban (20 mg once daily [OD], or 15 mg OD if creatinine clearance was 30-49 mL/min) or dose-adjusted warfarin (median follow-up: 707 days); rivaroxaban plasma concentration was measured in a subset of 161 patients. In this post hoc exposure-response analysis, a multivariate Cox model was used to correlate individual predicted rivaroxaban exposures and patient characteristics with time-to-event efficacy and safety outcomes in 7061 and 7111 patients, respectively. There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes. Creatinine clearance and history of stroke were significantly associated with efficacy outcomes. C trough  was significantly associated with the composite of major or non-major clinically relevant (NMCR) bleeding (hazard ratio [95th percentile vs. median]: 1.26 [95% confidence interval 1.13-1.40]) but not with major bleeding alone. The exposure-response relationship for major or NMCR bleeding was shallow with no clear threshold for an acceleration in risk. History of gastrointestinal bleeding had a greater influence on safety outcomes than C trough . These results support fixed rivaroxaban 15 mg and 20 mg OD dosages in NVAF. Therapeutic drug monitoring is unlikely to offer clinical benefits in this indication beyond evaluation of patient characteristics.",2020,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"['14,264 patients with NVAF', 'patients with non-valvular atrial fibrillation (NVAF', 'patients with non-valvular atrial fibrillation']","['rivaroxaban', 'Rivaroxaban']","['safety outcomes', 'rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes', 'composite of major or non-major clinically relevant (NMCR) bleeding', 'Creatinine clearance and history of stroke', 'rivaroxaban plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",14264.0,0.0632288,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA. LZhang11@ITS.JNJ.com.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Nandy', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hermanowski-Vosatka', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Manesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02077-9']
194,31773541,The effect of spinal manipulation on brain neurometabolites in chronic nonspecific low back pain patients: a randomized clinical trial.,"BACKGROUND


In patients with chronic nonspecific low back pain (NCLBP), brain function changes due to the neuroplastic changes in different regions.
AIM


The current study aimed to evaluate the brain metabolite changes after spinal manipulation, using proton magnetic resonance spectroscopy ( 1 H-MRS).
METHODS


In the current study, 25 patients with NCLBP aged 20-50 years were enrolled. Patients were randomly assigned to lumbopelvic manipulation or sham. Patients were evaluated before and 5 weeks after treatment by the Numerical Rating Scale (NRS), the Oswestry Disability Index (ODI), and  1 H-MRS.
RESULTS


After treatment, severity of pain and functional disability were significantly reduced in the treatment group vs. sham group (p < 0.05). After treatment, N-acetyl aspartate (NAA) in thalamus, insula, dorsolateral prefrontal cortex (DLPFC) regions, as well as choline (Cho) in the thalamus, insula, and somatosensory cortex (SSC) regions, had increased significantly in the treatment group compared with the sham group (p < 0.05). A significant increase was further observed in NAA in thalamus, anterior cingulate cortex (ACC), and SCC regions along with Cho metabolite in thalamus and SCC regions after treatment in the treatment group compared with the baseline measures (p < 0.05). Also, a significant increase was observed in Glx (glutamate and glutamine) levels of thalamus (p = 0.03). There was no significant difference in terms of brain metabolites at baseline and after treatment in the sham group.
CONCLUSION


In the patient with low back pain, spinal manipulation affects the central nervous system and changes the brain metabolites. Consequently, pain and functional disability are reduced.",2020,"After treatment, severity of pain and functional disability were significantly reduced in the treatment group vs. sham group (p < 0.05).","['25 patients with NCLBP aged 20-50\xa0years were enrolled', 'chronic nonspecific low back pain patients', 'patients with chronic nonspecific low back pain (NCLBP']","['spinal manipulation', 'lumbopelvic manipulation or sham', 'proton magnetic resonance spectroscopy ( 1 H-MRS']","['brain metabolite changes', 'pain and functional disability', 'Glx (glutamate and glutamine) levels of thalamus', 'severity of pain and functional disability', 'brain metabolites', 'NAA in thalamus, anterior cingulate cortex (ACC), and SCC regions along with Cho metabolite in thalamus and SCC regions', 'Numerical Rating Scale (NRS), the Oswestry Disability Index (ODI), and  1 H-MRS', 'brain neurometabolites']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]",,0.10606,"After treatment, severity of pain and functional disability were significantly reduced in the treatment group vs. sham group (p < 0.05).","[{'ForeName': 'Daryoush', 'Initials': 'D', 'LastName': 'Didehdar', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Kamali', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. dary1358@gmail.com.'}, {'ForeName': 'Amin Kordi', 'Initials': 'AK', 'LastName': 'Yoosefinejad', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrzad', 'Initials': 'M', 'LastName': 'Lotfi', 'Affiliation': 'Medical Imaging Research Center and Department of Radiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Irish journal of medical science,['10.1007/s11845-019-02140-2']
195,29802491,Intake of dietary carbohydrates in early adulthood and adolescence and breast density among young women.,"PURPOSE


Carbohydrate intake increases postprandial insulin secretion and may affect breast density, a strong risk factor for breast cancer, early in life. We examined associations of adolescent and early adulthood intakes of total carbohydrates, glycemic index/load, fiber, and simple sugars with breast density among 182 young women.
METHODS


Diet was assessed using three 24-h recalls at each of five Dietary Intervention Study in Children (DISC) clinic visits when participants were age 10-19 years and at the DISC06 Follow-Up Study clinic visit when participants were age 25-29 years. Associations between energy-adjusted carbohydrates and MRI-measured percent dense breast volume (%DBV) and absolute dense breast volume (ADBV) at 25-29 years were quantified using multivariable-adjusted mixed-effects linear models.
RESULTS


Adolescent sucrose intakes and premenarcheal total carbohydrates intakes were modestly associated with higher %DBV (mean %DBV Q1 vs Q4 , 16.6 vs 23.5% for sucrose; and 17.2 vs 22.3% for premenarcheal total carbohydrates, all P trend  ≤ 0.02), but not with ADBV. However, adolescent intakes of fiber and fructose were not associated with %DBV and ADBV. Early adulthood intakes of total carbohydrates, glycemic index/load, fiber, and simple sugars were not associated with %DBV and ADBV.
CONCLUSIONS


Insulinemic carbohydrate diet during puberty may be associated with adulthood breast density, but our findings need replication in larger studies. Clinical Trials Registration ClinicalTrials.gov Identifier, NCT00458588 April 9, 2007; NCT00000459 October 27, 1999.",2018,"Early adulthood intakes of total carbohydrates, glycemic index/load, fiber, and simple sugars were not associated with %DBV and ADBV.
","['182 young women', 'Children (DISC) clinic visits when participants were age 10-19\xa0years and at the DISC06 Follow-Up Study clinic visit when participants were age 25-29\xa0years', 'early adulthood and adolescence and breast density among young women']","['Insulinemic carbohydrate diet', 'dietary carbohydrates']","['adolescent intakes of fiber and fructose', 'Early adulthood intakes of total carbohydrates, glycemic index/load, fiber, and simple sugars', 'postprandial insulin secretion', 'Adolescent sucrose intakes and premenarcheal total carbohydrates intakes']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1659543', 'cui_str': 'Breast Density'}]","[{'cui': 'C0301577', 'cui_str': 'Carbohydrate diet (finding)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0026492', 'cui_str': 'Simple Sugars'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0556137', 'cui_str': 'Sucrose intake (observable entity)'}]",182.0,0.019658,"Early adulthood intakes of total carbohydrates, glycemic index/load, fiber, and simple sugars were not associated with %DBV and ADBV.
","[{'ForeName': 'Seungyoun', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Howard Hall 102E, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Goloubeva', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Howard Hall 102E, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Hylton', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Klifa', 'Affiliation': 'Dangeard Group, Luynes, France.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shepherd', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Snetselaar', 'Affiliation': 'Department of Epidemiology, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Dorgan', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Howard Hall 102E, Baltimore, MD, 21201, USA. jdorgan@som.umaryland.edu.'}]",Cancer causes & control : CCC,['10.1007/s10552-018-1040-1']
196,32320773,"Surgery versus combined treatment with curettage and imiquimod for nodular basal cell carcinoma: One-year results of a noninferiority, randomized, controlled trial.","PURPOSE


Nodular basal cell carcinoma (nBCC) is mostly treated with surgical excision. Interest in minimally invasive treatment of these low-risk tumors is increasing. We assessed the effectiveness of nBCC treatment with curettage and imiquimod cream compared with surgical excision.
METHODS


Patients with nBCC included in this randomized, controlled noninferiority trial were randomly assigned to either a curettage and imiquimod cream group or a surgical excision group. The primary endpoint was the proportion of patients free from treatment failure 1 year after the end of treatment. A prespecified noninferiority margin of 8% was used. A modified intention-to-treat and a per-protocol analysis was performed (ClinicalTrials.gov identifier NCT02242929).
RESULTS


One hundred forty-five patients were randomized: 73 to the curettage and imiquimod cream group and 72 to the surgical excision group. The proportion of patients free of recurrence after 12 months was 86.3% (63/73) for the curettage and imiquimod group and 100% (72/72) for the surgical excision group. The difference in efficacy was -13.7% (95% confidence interval -21.6% to -5.8%; 1-sided P = .0004) favoring surgical excision.
CONCLUSION


Noninferiority of curettage and imiquimod cream cannot be concluded. Given the still high efficacy of curettage and imiquimod cream and the indolent growth pattern of nBCC, curettage and imiquimod could still be a valuable treatment option with the possibility to prevent overuse of excisions. However, it cannot replace surgical excision.",2020,Proportion of patients free of recurrence after 12 months was 86.3% for curettage and imiquimod (63/73) and 100% for excision (72/72).,"['Nodular basal cell carcinoma (nBCC', '145 patients were randomized; 73 to', 'Patients with nodular BCC', 'Nodular basal cell carcinoma (SCIN']","['imiquimod cream', 'curettage and imiquimod cream and 72 to surgical excision', 'imiquimod', 'Surgery versus combined treatment with Curettage and Imiquimod', 'nBCC', 'curettage and imiquimod cream or surgical excision', 'curettage and imiquimod cream']","['efficacy', 'proportion of patients free from treatment failure one 1 year']","[{'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C4721806', 'cui_str': 'Basal cell carcinoma of skin'}]","[{'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439234', 'cui_str': 'year'}]",145.0,0.0800048,Proportion of patients free of recurrence after 12 months was 86.3% for curettage and imiquimod (63/73) and 100% for excision (72/72).,"[{'ForeName': 'Kelly A E', 'Initials': 'KAE', 'LastName': 'Sinx', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. Electronic address: kelly.sinx@mumc.nl.'}, {'ForeName': 'Patty J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Nicole W J', 'Initials': 'NWJ', 'LastName': 'Kelleners-Smeets', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Veronique J L', 'Initials': 'VJL', 'LastName': 'Winnepenninckx', 'Affiliation': 'Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Aimee H M M', 'Initials': 'AHMM', 'LastName': 'Arits', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands; Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Dermatology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Mosterd', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.053']
197,32205376,Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial.,"INTRODUCTION


Gay, bisexual and other men who have sex with men (gbMSM) have an increased risk of human papillomavirus (HPV) infection and HPV-associated diseases, such as anal cancer and anogenital warts. A carrageenan-based lubricant could prevent HPV infection, thereby reducing the disease burden in this population. This paper describes the protocol for the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) study, an ongoing randomised controlled trial (RCT), evaluating efficacy of a carrageenan-based personal lubricant in reducing type-specific anal HPV incidence and prevalence among sexually active gbMSM, efficacy by HIV status, safety and tolerability of the gel and participant adherence to the intervention.
METHODS AND ANALYSIS


The study is a double-blinded, placebo-controlled RCT. Volunteer gbMSM 18 years and older are randomly assigned 1:1 to receive the treatment (a self-applied anal microbicide gel with carrageenan) or placebo (a self-applied placebo gel). At each visit, computerised questionnaires are used to collect data on sociodemographic and clinical variables, lifestyle, sexual behaviour and the gels' safety and tolerability. At baseline and each follow-up visit (months 1, 2, 3, 6, 9 and 12), nurses collect anal specimens tested for 36 HPV types (linear array assay). HIV status is determined at baseline and 12 months. The primary outcome is incidence of type-specific anal HPV infection(s) undetected at baseline. Secondary outcomes are prevalence of type-specific anal HPV infection, safety, tolerability and adherence. We aim to recruit 380 participants to attain the study's objectives. Data will be analysed using intention-to-treat and per-protocol approaches with subgroup analyses by HIV status.
ETHICS AND DISSEMINATION


Ethics approval was obtained by the Research Ethics Boards of McGill University, the McGill University Health Centre, Concordia University and Centre Hospitalier de l'Université de Montréal. Trial results will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT02354144.",2020,"INTRODUCTION


Gay, bisexual and other men who have sex with men (gbMSM) have an increased risk of human papillomavirus (HPV) infection and HPV-associated diseases, such as anal cancer and anogenital warts.","['Gay, bisexual and other men who have sex with men (gbMSM', 'Men to Inhibit Transmission of HPV Infection (LIMIT-HPV', 'Volunteer gbMSM 18 years and older', ""380 participants to attain the study's objectives""]","['self-applied anal microbicide gel with carrageenan) or placebo (a self-applied placebo gel', 'carrageenan-based personal lubricant', 'placebo-controlled RCT']","['prevalence of type-specific anal HPV infection, safety, tolerability and adherence', 'incidence of type-specific anal HPV infection(s', 'HIV status']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0007289', 'cui_str': 'Carrageenan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",380.0,0.311921,"INTRODUCTION


Gay, bisexual and other men who have sex with men (gbMSM) have an increased risk of human papillomavirus (HPV) infection and HPV-associated diseases, such as anal cancer and anogenital warts.","[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Laurie', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'El-Zein', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tota', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Tellier', 'Affiliation': 'Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Coutlée', 'Affiliation': ""Service de Microbiologie Médicale et Service d'Infectiologie, Départements de Médecine et de médecine de laboratoire, Centre Hospitalier de L'Universite de Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'de Pokomandy', 'Affiliation': 'Department of Family Medicine, McGill University, Montreal, Quebec, Canada alexandra.depokomandy@mcgill.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035113']
198,31260833,Lung Cancer Incidence and Mortality with Extended Follow-up in the National Lung Screening Trial.,"INTRODUCTION


The National Lung Screening Trial (NLST) randomized high-risk current and former smokers to three annual screens with either low-dose computed tomography (LDCT) or chest radiography (CXR) and demonstrated a significant reduction in lung cancer mortality in the LDCT arm after a median of 6.5 years' follow-up. We report on extended follow-up of NLST subjects.
METHODS


Subjects were followed by linkage to state cancer registries and the National Death Index. The number needed to screen (NNS) to prevent one lung cancer death was computed as the reciprocal of the difference in the proportion of patients dying of lung cancer across arms. Lung cancer mortality rate ratios (RRs) were computed overall and adjusted for dilution effect, with the latter including only deaths with a corresponding diagnosis close enough to the end of protocol screening.
RESULTS


The median follow-up times were 11.3 years for incidence and 12.3 years for mortality. In all, 1701 and 1681 lung cancers were diagnosed in the LDCT and CXR arms, respectively (RR = 1.01, 95% confidence interval [CI]: 0.95-1.09). The observed numbers of lung cancer deaths were 1147 (with LDCT) versus 1236 (with CXR) (RR = 0.92, 95% CI: 0.85-1.00). The difference in the number of patients dying of lung cancer (per 1000) across arms was 3.3, translating into an NNS of 303, which is similar to the original NNS estimate of around 320. The dilution-adjusted lung cancer mortality RR was 0.89 (95% CI: 0.80-0.997). With regard to overall mortality, there were 5253 (with LDCT) and 5366 (with CXR) deaths, for a difference across arms (per 1000) of 4.2 (95% CI: -2.6 to 10.9).
CONCLUSION


Extended follow-up of the NLST showed an NNS similar to that of the original analysis. There was no overall increase in lung cancer incidence in the LDCT arm versus in the CXR arm.",2019,"Observed lung cancer deaths were 1147 (LDCT) versus 1236 (CXR), RR=0.92 (95% CI: 0.85-1.00).",['Subjects were followed by linkage to state cancer registries and the National Death Index'],"['LDCT', 'NLST', 'low-dose computed tomography (LDCT) or chest radiographs (CXR']","['lung cancer mortality', 'lung cancer incidence', 'overall mortality', 'number (per 1,000) dying of lung cancer', 'dilution-adjusted lung cancer mortality RR', 'Lung cancer mortality rate ratios (RRs', 'Observed lung cancer deaths', 'mortality', 'Lung Cancer Incidence and Mortality']","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.128334,"Observed lung cancer deaths were 1147 (LDCT) versus 1236 (CXR), RR=0.92 (95% CI: 0.85-1.00).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.05.044']
199,32320100,Randomised controlled trial of a comprehensive protocol for preventing constipation following total hip arthroplasty.,"AIMS AND OBJECTIVES


To evaluate the efficacy and safety of a comprehensive protocol for constipation prevention.
BACKGROUND


Constipation is a common problem for patients undergoing total hip arthroplasty (THA), yet sparse evidence is available to guide constipation prevention after THA.
DESIGN


Randomised controlled superiority clinical trial.
METHODS


This randomised controlled study was carried out according to the Consolidated Standards of Reporting Trials (CONSORT). A total of 80 THA patients were randomised to receive only preoperative education about lifestyle or the combination of education with postoperative abdominal massage and polyethylene glycol 4,000 (Forlax®). Efficacy outcomes included rates of postoperative constipation and enema rescue, as well as time to first postoperative defecation and readmission within 30 days. Safety outcomes were number and type of adverse events.
RESULTS


Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalisation than patients who received only preoperative education (25% versus 55%), and they showed a significantly lower rate of enema rescue (12.5% versus 40%). Many more patients receiving combination treatment experienced their first defecation within two postoperative days than patients who received only preoperative education (62.5% versus 35.9%). In contrast, the two groups were similar in terms of constipation rate on postoperative days 15 and 30, rate of readmission within 30 days and rate of postoperative adverse events.
CONCLUSIONS


These results suggest that our comprehensive protocol can relieve constipation after THA, reduce the need for enema rescue and shorten time to first defecation without sacrificing safety. More work is needed to optimise and develop this protocol further.
RELEVANCE TO CLINICAL PRACTICE


Constipation is a distressing problem that frequently occurs after THA. This study confirmed that a comprehensive protocol including preoperative education, postoperative abdominal massage and polyethylene glycol 4,000 can effectively relieve constipation after THA without sacrificing safety.",2020,"RESULTS


Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalization than patients who received only preoperative education (25% vs 55%), and they showed a significantly lower rate of enema rescue (12.5% vs 40%).","['80 THA patients', 'constipation following total hip arthroplasty', 'patients undergoing total hip arthroplasty (THA']","['preoperative education, postoperative abdominal massage and polyethylene glycol', 'preoperative education about lifestyle, or the combination of education with postoperative abdominal massage and polyethylene glycol 4000 (Forlax®', 'comprehensive protocol']","['rate of readmission within 30 days, and rate of postoperative adverse events', 'rate of postoperative constipation during hospitalization', 'efficacy and safety', 'rate of enema rescue', 'rates of postoperative constipation and enema rescue, as well as time to first postoperative defecation and readmission within 30 days', 'constipation rate', 'number and type of adverse events']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0948179', 'cui_str': 'Postoperative constipation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014268', 'cui_str': 'Giving patient an enema'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",80.0,0.108095,"RESULTS


Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalization than patients who received only preoperative education (25% vs 55%), and they showed a significantly lower rate of enema rescue (12.5% vs 40%).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Youwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}]",Journal of clinical nursing,['10.1111/jocn.15299']
200,32316288,Relative Validity of an Online Herb and Spice Consumption Questionnaire.,"Culinary herbs and spices contribute bioactives to the diet, which act to reduce systemic inflammation and associated disease. Investigating the health effects of herb/spice consumption is hampered, however, by a scarcity of dietary assessment tools designed to collect herb/spice data. The objective of this study was to determine the relative validity of an online 28-item herb/spices intake questionnaire (HSQ). In randomized order, 62 volunteers residing in Idaho, USA, completed the online Diet History Questionnaire III + the HSQ followed one week later by one of two comparative methods: 7-day food records or three telephone-administered 24-h dietary recalls. Relative validity of the HSQ was tested two ways: (1) by comparing herb/spice intakes between the HSQ and comparator, and (2) by determining the correlation between herb/spice data and Healthy Eating Index 2015 score. The HSQ and both comparators identified black pepper, cinnamon and garlic powder as the three most commonly used herbs/spices. The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators. The number of herbs/spices consumed was significantly directly correlated with diet quality for the HSQ. These results support the ability of the HSQ to record general herb/spice use, yet suggest that further validation testing is needed.",2020,The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators.,"['62 volunteers residing in Idaho, USA, completed the']","['online 28-item herb/spices intake questionnaire (HSQ', 'Online Herb and Spice Consumption Questionnaire', 'online Diet History Questionnaire III + the HSQ followed one week later by one of two comparative methods: 7-day food records or three telephone-administered 24-h dietary recalls']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0020787', 'cui_str': 'Idaho'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0037910', 'cui_str': 'Spice'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453242', 'cui_str': 'Herbs and spices'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",[],62.0,0.0272359,The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Blanton', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83201-8117, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17082757']
201,32317241,Conventional vs machine learning-based treatment planning in prostate brachytherapy: Results of a Phase I randomized controlled trial.,"PURPOSE


The purpose of this study was to evaluate the noninferiority of Day 30 dosimetry between a machine learning-based treatment planning system for prostate low-dose-rate (LDR) brachytherapy and the conventional, manual planning technique. As a secondary objective, the impact of planning technique on clinical workflow efficiency was also evaluated.
MATERIALS AND METHODS


41 consecutive patients who underwent I-125 LDR monotherapy for low- and intermediate-risk prostate cancer were accrued into this single-institution study between 2017 and 2018. Patients were 1:1 randomized to receive treatment planning using a machine learning-based prostate implant planning algorithm (PIPA system) or conventional, manual technique. Treatment plan modifications by the radiation oncologist were evaluated by computing the Dice coefficient of the prostate V 150%  isodose volume between either the PIPA-or conventional-and final approved plans. Additional evaluations between groups evaluated the total planning time and dosimetric outcomes at preimplant and Day 30.
RESULTS


21 and 20 patients were treated using the PIPA and conventional techniques, respectively. No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc  between PIPA and conventional techniques. Although the PIPA group had a larger proportion of patients with plans requiring no modifications (Dice = 1.00), there was no significant difference between the magnitude of modifications between each arm. There was a large significant advantage in mean planning time for the PIPA arm (2.38 ± 0.96 min) compared with the conventional (43.13 ± 58.70 min) technique (p >> 0.05).
CONCLUSIONS


A machine learning-based planning workflow for prostate LDR brachytherapy has the potential to offer significant time savings and operational efficiencies, while producing noninferior postoperative dosimetry to that of expert, conventional treatment planners.",2020,"No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc  between PIPA and conventional techniques.","['for low- and intermediate-risk prostate cancer were accrued into this single-institution study between 2017 and 2018', '41 consecutive patients who underwent']","['Conventional vs machine learning-based treatment planning in prostate brachytherapy', 'machine learning-based prostate implant planning algorithm (PIPA system) or conventional, manual technique', 'machine learning-based treatment planning system for prostate low-dose-rate (LDR) brachytherapy and the conventional, manual planning technique', 'I-125 LDR monotherapy', 'PIPA']","['clinical workflow efficiency', 'mean planning time', 'total planning time and dosimetric outcomes']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0854662', 'cui_str': 'Brachytherapy to prostate'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0032076', 'cui_str': 'Planning Methodology'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",41.0,0.0160555,"No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc  between PIPA and conventional techniques.","[{'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Nicolae', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Semple', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Morton', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Lucas Castro', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Chia-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada. Electronic address: ananth.ravi@sunnybrook.ca.'}]",Brachytherapy,['10.1016/j.brachy.2020.03.004']
202,32317470,Comparison of platelet-rich plasma and inverted internal limiting membrane flap for the management of large macular holes: A pilot study.,"Purpose


To compare the safety and efficacy of 25-gauge pars plana vitrectomy (PPV) with either platelet-rich plasma (PRP) or inverted internal limiting membrane (ILM) flap for the treatment of large macular hole.
Methods


Pseudophakic patients with idiopathic macular holes with a minimum diameter (MD) of 600-1500 μm were randomized into two groups (30 patients each): 25-gauge PPV with either inverted ILM flap (group A) or PRP (group B).
Results


Mean MD in groups A and B were 803.33 ± 120.65 μm and 784.73 ± 120.10 μm, respectively (P = 0.552). Mean base diameter in groups A and B was 1395.17 ± 240.57 μm and 1486.90 ± 281.61 μm, respectively (P = 0.180). The median presenting best-corrected visual acuity (BCVA) was logMAR 0.78 (range 0.78-1.00) and logMAR 0.78 (Range 0.60-1.00) in groups A and B, respectively (P = 0.103). Anatomical closure was achieved in 90% (n = 27/30) and 93.3% (n = 28/30) eyes in groups A and B, respectively (P = 0.158). Type 1 closure was achieved in 76.7% (n = 23/30) and 83.3% (n = 25/30) eyes in groups A and B, respectively. Median BCVA at postoperative 3-month in groups A and B was logMAR 0.60 (range 0.48-0.60) and logMAR 0.60 (range 0.48-0.78), respectively (P = 0.312). The average visual improvement was 2.0 and 2.5 early treatment diabetic retinopathy study (ETDRS) lines in groups A and B, respectively (P = 0.339). None of the patients developed postoperative exaggerated inflammatory reactions.
Conclusion


Using platelets for the treatment of large macular holes is as safe and effective as an inverted ILM flap.",2020,"Anatomical closure was achieved in 90% (n = 27/30) and 93.3% (n = 28/30) eyes in groups A and B, respectively (P = 0.158).","['large macular holes', 'large macular hole', 'Pseudophakic patients with idiopathic macular holes with a minimum diameter (MD) of 600-1500 μm were randomized into two groups (30 patients each']","['PRP', '25-gauge pars plana vitrectomy (PPV) with either platelet-rich plasma (PRP) or inverted internal limiting membrane (ILM) flap', '25-gauge PPV with either inverted ILM flap', 'platelet-rich plasma and inverted internal limiting membrane flap']","['median presenting best-corrected visual acuity (BCVA', 'average visual improvement', 'Median BCVA', 'Anatomical closure', 'safety and efficacy', 'postoperative exaggerated inflammatory reactions']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C4522321', 'cui_str': 'Inverted'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0280209,"Anatomical closure was achieved in 90% (n = 27/30) and 93.3% (n = 28/30) eyes in groups A and B, respectively (P = 0.158).","[{'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Babu', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Kohli', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'N Obuli', 'Initials': 'NO', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Olukorede O', 'Initials': 'OO', 'LastName': 'Adenuga', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Ahuja', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1357_19']
203,30899994,Abaloparatide effect on forearm bone mineral density and wrist fracture risk in postmenopausal women with osteoporosis.,"PURPOSE


Wrist fractures are common, contribute significantly to morbidity in women with postmenopausal osteoporosis, and occur predominantly at the ultradistal radius, a site rich in trabecular bone. This exploratory analysis of the phase 3 ACTIVE study evaluated effects of abaloparatide versus placebo and teriparatide on forearm bone mineral density (BMD) and risk of wrist fracture.
METHODS


Forearm BMD was measured by dual energy X-ray absorptiometry in a subset of 982 women from ACTIVE, evenly distributed across the three treatment groups. Wrist fractures were ascertained in the total cohort (N = 2463).
RESULTS


After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001). At 18 months, 1/3 radius BMD losses (versus baseline) were similar for abaloparatide compared with placebo (-0.42; 95% CI -1.03, 0.20; p = 0.19) but losses with teriparatide exceeded those of placebo (-1.66%; 95% CI -2.27, -1.06; p < 0.001). The decline with abaloparatide was less than that seen with teriparatide (group difference 1.22%; 95% CI 0.57, 1.87; p < 0.001). The radius BMD findings, at both ultradistal and 1/3 sites, are consistent with the numerically lower incidence of wrist fractures observed in women treated with abaloparatide compared with teriparatide (HR = 0.43; 95% CI 0.18, 1.03; p = 0.052) and placebo (HR = 0.49, 95% CI 0.20, 1.19, p = 0.11).
CONCLUSIONS


Compared with teriparatide, abaloparatide increased BMD at the ultradistal radius (primarily trabecular bone) and decreased BMD to a lesser extent at the 1/3 radius (primarily cortical bone), likely contributing to the numerically lower wrist fracture incidence observed with abaloparatide.",2019,"After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001).","['982 women from ACTIVE, evenly distributed across the three treatment groups', 'postmenopausal women with osteoporosis', 'women with postmenopausal osteoporosis']","['abaloparatide versus placebo and teriparatide', 'placebo', 'teriparatide']","['Wrist fractures', 'BMD', 'forearm bone mineral density (BMD) and risk of wrist fracture', 'wrist fractures', 'radius BMD losses', 'ultradistal radius BMD changes', 'forearm bone mineral density and wrist fracture risk', 'decline with abaloparatide', 'radius BMD findings']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}]","[{'cui': 'C0435630', 'cui_str': 'Fracture of distal end of radius and ulna (disorder)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",,0.361972,"After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001).","[{'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA. nelson.watts@hotmail.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, Lakewood, CO, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-04890-2']
204,31902567,Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: A randomized clinical trial.,"Methamphetamine is the most commonly used illicit drug in China. We previously demonstrated that 10 Hz rTMS over the DLPFC reduces craving in methamphetamine users. Here, we applied intermittent theta burst stimulation (iTBS), a new form of rTMS, in a large sample at four clinical centers. 126 participants (age 31.64 ± 6.33; 106 men) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either iTBS or sham over the DLPFC for four weeks (20 daily sessions, 900 pulses per day). Cue-induced craving and cognitive function were assessed before and after rTMS intervention. Relapse was followed up by urine test after discharge from the rehabilitation center. iTBS significantly reduced craving and improved cognition and sleep quality. This study suggests that rTMS may be a useful and safe treatment option for methamphetamine use disorder, warranting future large scale trials.",2020,iTBS significantly reduced craving and improved cognition and sleep quality.,"['methamphetamine addiction', '126 participants (age 31.64\xa0±\xa06.33; 106 men) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst stimulation (iTBS', 'rTMS', 'Methamphetamine', 'Intermittent theta burst transcranial magnetic stimulation', 'iTBS or sham over the DLPFC']","['craving and improved cognition and sleep quality', 'Relapse', 'Cue-induced craving and cognitive function']","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",126.0,0.162421,iTBS significantly reduced craving and improved cognition and sleep quality.,"[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Sciences, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.12.114']
205,31628475,Smoking Topography Characteristics During a 6-Week Trial of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.,"INTRODUCTION


A nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low nicotine content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI.
AIMS AND METHODS


After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg nicotine per g tobacco) or normal nicotine content (NNC; 15.8 mg nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates.
RESULTS


At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
CONCLUSIONS


Findings are consistent with acute VLNC cigarette topography studies and indicate that a nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI.
IMPLICATIONS


Given the high smoking rates among people with SMI, understanding how a nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if nicotine content is lowered to minimally addictive levels.",2020,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","['smokers with SMI (N=58', 'smokers with serious mental illness (SMI', 'smokers with serious mental illness', 'smokers with SMI']","['smoking very low nicotine content (VLNC) cigarettes', 'VLNC (0.4 mg nicotine/g tobacco) or normal nicotine content (NNC; 15.8 mg/g) research cigarettes for six weeks', 'nicotine content cigarettes', 'handheld smoking topography device']","['cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost', 'VLNC condition smoked fewer puffs per cigarette and had shorter inter-puff intervals']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0035168'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0201706,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Baptist Comprehensive Cancer Center and Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rubin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'DeAtley', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz198']
206,32302308,Effectiveness of the Common Elements Treatment Approach (CETA) in reducing intimate partner violence and hazardous alcohol use in Zambia (VATU): A randomized controlled trial.,"BACKGROUND


Both intimate partner violence (IPV) and alcohol misuse are highly prevalent, and partner alcohol misuse is a significant contributor to women's risk for IPV. There are few evidence-based interventions to address these problems in low- and middle-income countries (LMICs). We evaluated the effectiveness of an evidence-based, multi-problem, flexible, transdiagnostic intervention, the Common Elements Treatment Approach (CETA) in reducing (a) women's experience of IPV and (b) their male partner's alcohol misuse among couples in urban Zambia.
METHODS AND FINDINGS


This was a single-blind, parallel-assignment randomized controlled trial in Lusaka, Zambia. Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use were enrolled as a couple and randomized to CETA or treatment as usual plus safety checks (TAU-Plus). The primary outcome, IPV, was assessed by the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT). Assessors were blinded. Analyses were intent-to-treat. Primary outcome assessments were planned at post-treatment, 12 months post-baseline, and 24 months post-baseline. Enrollment was conducted between May 23, 2016, and December 17, 2016. In total, 123 couples were randomized to CETA, 125 to TAU-Plus. The majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age. Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49). Similarly, mean reduction in AUDIT score at 12 months post-baseline was statistically significantly greater among men who received CETA compared to men who received TAU (-4.5, 95% CI -6.9 to -2.2, p < 0.001, Cohen's d effect size = 0.43). The Data and Safety Monitoring Board recommended the trial be stopped early due to treatment effectiveness following the 12-month post-baseline assessment, and CETA was offered to control participants. Limitations of the trial included the lack of a true control condition (i.e., that received no intervention), self-reported outcomes that may be subject to social desirability bias, and low statistical power for secondary IPV outcomes.
CONCLUSIONS


Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia. Future research and programming should include tertiary prevention approaches to IPV, such as CETA, rather than offering only community mobilization and primary prevention.
TRIAL REGISTRATION


The trial was registered on ClinicalTrials.gov (NCT02790827).",2020,"Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49).","[""a) women's experience of IPV and (b) their male partner's alcohol misuse among couples in urban Zambia"", 'majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age', '123 couples', 'Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use', 'intimate partner violence and hazardous alcohol use in Zambia (VATU']","['TAU', 'Common Elements Treatment Approach (CETA', 'CETA', 'TAU-Plus']","['IPV', 'Mean reduction in IPV (via SVAWS subscale score', 'mean reduction in AUDIT score', 'Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C2015861', 'cui_str': 'Multiple birth'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}]",123.0,0.188015,"Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49).","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Skavenski van Wyk', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Flor', 'Initials': 'F', 'LastName': 'Melendez', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Zambia, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Kmett Danielson', 'Affiliation': 'National Crime Victims Research and Treatment Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mayeya', 'Affiliation': 'Ministry of Health-Zambia, Chainama Hills College Hospital, Lusaka, Zambia.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Simenda', 'Affiliation': 'Chainama Hills College Hospital, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bolton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003056']
207,32145827,"Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomised, non-inferiority trial.","BACKGROUND


Optimal treatment regimens for AIDS-associated Kaposi sarcoma, a frequent contributor to morbidity and mortality among people with HIV, have not been systematically evaluated in low-income and middle-income countries, where the disease is most common. In this study, we aimed to investigate optimal treatment strategies for advanced stage disease in areas of high prevalence and limited resources.
METHODS


In this open-label, non-inferiority trial, we enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Eligible participants were randomly assigned (1:1:1) with a centralised computer system to receive either intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the control arm), together with antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine). The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group. Safety was assessed in all eligible treated study participants. The study was registered with ClinicalTrials.gov, NCT01435018.
FINDINGS


334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the bleomycin and vincristine plus ART arm, as per the recommendations of the Data and Safety Monitoring Board (DSMB). The etoposide plus ART arm also closed due to inferiority in March, 2016, following a DSMB recommendation. Week-48 PFS rates were higher in the paclitaxel plus ART arm than in both investigational arms. The absolute differences in PFS were -30% (95% CI -52 to -8) for the comparison of paclitaxel plus ART (week 48 PFS 50%, 32 to 67; n=59) and etoposide plus ART (20%, 6 to 33; n=59), and -20% (-33% to -7%) for the comparison of paclitaxel plus ART (64%, 55 to 73; n=138) and bleomycin and vincristine plus ART (44%, 35 to 53; n=132). Both CIs overlapped the non-inferiority margin. The most common adverse events, in 329 eligible participants who began treatment, were neutropenia (48 [15%]), low serum albumin (33 [10%]), weight loss (29 [9%]), and anaemia (28 [9%]), occurring at similar frequency across treatment arms.
INTERPRETATION


Non-inferiority of either investigational intervention was not shown, with paclitaxel plus ART showing superiority to both oral etoposide plus ART and bleomycin and vincristine plus ART, supporting its use in treating advanced AIDS-associated Kaposi sarcoma in resource-limited settings.
FUNDING


US National Institute of Allergy and Infectious Diseases and National Cancer Institute, National Institutes of Health.",2020,"The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group.","['334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the', 'people with HIV', 'enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe', 'advanced stage disease in areas of high prevalence and limited resources', 'Eligible participants']","['antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine', 'paclitaxel plus ART', 'etoposide plus ART', 'intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel', 'bleomycin and vincristine plus ART']","['progression-free survival (PFS', 'low serum albumin', 'weight loss', 'neutropenia', 'PFS', 'Safety', 'Week-48 PFS rates']","[{'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0036220', 'cui_str': 'Kaposi Sarcoma'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1320290', 'cui_str': 'Clinical trial group'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",329.0,0.329646,"The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group.","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Krown', 'Affiliation': 'AIDS Malignancy Consortium, New York, NY, USA. Electronic address: krowns@mskcc.org.'}, {'ForeName': 'Carlee B', 'Initials': 'CB', 'LastName': 'Moser', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'MacPhail', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Matining', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Caruso', 'Affiliation': 'Frontier Science Foundation, Amherst, NY, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi; Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Division of Infectious Diseases, Chapel Hill, NC, USA.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Parirenyatwa Clinical Research Site, Harare, Zimbabwe.'}, {'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Research Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Naftali W', 'Initials': 'NW', 'LastName': 'Busakhala', 'Affiliation': 'Moi University School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Okuku', 'Affiliation': 'Uganda Cancer Institute, Kampala, Uganda.'}, {'ForeName': 'Josphat', 'Initials': 'J', 'LastName': 'Kosgei', 'Affiliation': 'Kenya Medical Research Institute, USA Medical Directorate for Africa/Kenya, Kericho, Kenya.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Hoagland', 'Affiliation': 'Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Vincent O', 'Initials': 'VO', 'LastName': 'Oliver', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Centers for Disease Control and Prevention, Kisumu CRS, HIV-Research Branch, Kisumu, Kenya.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': 'Family Clinical Research Unit CRS, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa; Division of Radiation Oncology, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International Clinical Research Site, Enhancing Care Foundation, Durban, South Africa.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Nokta', 'Affiliation': 'Office of HIV and AIDS Malignancy, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Margaret Z', 'Initials': 'MZ', 'LastName': 'Borok', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)33222-2']
208,32187881,"Licogliflozin, a Novel SGLT1 and 2 Inhibitor: Body Weight Effects in a Randomized Trial in Adults with Overweight or Obesity.","OBJECTIVE


The aim of this study was to explore the dose response of licogliflozin, a dual inhibitor of sodium/glucose cotransporter 1 (SGLT1) and 2 (SGLT2), by evaluating change in body weight in adults with overweight or obesity.
METHODS


This dose-response analysis evaluated change in body weight following 24 weeks with four once-daily and twice-daily licogliflozin doses (2.5-150 mg) versus placebo (primary end point). A further 24-week analysis evaluated the efficacy and safety of two once-daily licogliflozin doses in maintaining initial weight reduction.
RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001). However, mean adjusted percent changes in body weight after 24 weeks were modest, ranging from -0.45% to -3.83% (in the 50 mg twice daily group [95% CI: -5.26% to -2.48%]; n = 75). Responder analysis of ≥ 5% weight loss at week 24 revealed significant differences versus placebo, which were most pronounced with highest doses of 50 mg twice daily (45.3%) and 150 mg once daily (42.9%) (both P < 0.01). While weight loss was greater at higher doses, gastrointestinal adverse events were also more frequent. The 50-mg once-daily dose had perhaps the best balance between efficacy and tolerability.
CONCLUSIONS


Licogliflozin produced significant reductions in body weight versus placebo. However, the magnitude of weight reduction was modest.",2020,"RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001).","['Adults with Overweight or Obesity', 'adults with overweight or obesity']","['licogliflozin, a dual inhibitor of sodium/glucose cotransporter 1 (SGLT1)\xa0and 2\xa0(SGLT2', 'placebo', 'Licogliflozin', 'licogliflozin']","['body weight', 'efficacy and tolerability', 'weight loss', 'efficacy and safety', 'gastrointestinal adverse events', 'weight reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0643053,"RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001).","[{'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA.'}, {'ForeName': 'Plamen', 'Initials': 'P', 'LastName': 'Kozlovski', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Proot', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22764']
209,31302234,SWOG S1400C (NCT02154490)-A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy).,"OBJECTIVE


Lung-MAP (SWOG S1400) is a master platform trial assessing targeted therapies in squamous NSCLC. The objective of study C (S1400C) was to evaluate the response rate to palbociclib, a cyclin-dependent kinase 4 and cyclin-dependent kinase 6 inhibitor, in patients with cell cycle gene abnormalities.
METHODS


Patients with squamous NSCLC, a performance status of 0 to 2, and normal organ function who had progressed after at least one prior platinum-based chemotherapy with cyclin-dependent kinase 4 gene (CDK4) or cyclin D1 gene (CCND1), cyclin D2 gene (CCND2), or cyclin D3 gene (CCND3) amplifications on tumor specimens were eligible. The study was originally designed as a phase II/III trial comparing palbociclib with docetaxel, but it was modified to a single-arm phase II trial with the primary end point of response when immunotherapy was approved. If two or fewer responses were seen in the first 20 patients, then the study would cease enrollment.
RESULTS


A total of 88 patients (9% of patients screened) were assigned to S1400C, and 53 patients enrolled (including 17 to receive docetaxel). One patient who had been registered to receive docetaxel was re-registered to receive palbociclib after progression while taking docetaxel. The frequencies of cell cycle gene alterations in the eligible patients taking palbociclib (n = 32) were as follows: CCND1, 81% (n = 26); CCND2, 9% (n = 3); CCND3, 6% (n = 2); and CDK4, 3% (n = 1). In all, 32 eligible patients received palbociclib. There were two partial responses (response rate 6% [95% confidence interval (CI): 0%-15%]), both with CCND1 amplification. Twelve patients had stable disease (38% [95% CI: 21%-54%]). The median progression-free survival was 1.7 months (95% CI: 1.6-2.9 months) and the median overall survival was 7.1 months (95% CI: 4.2-12.5).
CONCLUSION


Palbociclib as monotherapy failed to demonstrate the prespecified criteria for advancement to phase III testing.",2019,"The median progression-free survival was 1.7 months (95% CI: 1.6-2.9 months) and the median overall survival was 7.1 months (95% CI: 4.2-12.5).
","['88 patients (9% of patients screened) were assigned to S1400C, and 53 patients enrolled (including 17 to receive', 'One patient who had been registered to receive', 'patients with cell cycle gene abnormalities', 'eligible patients taking palbociclib (n\xa0= 32) were as follows', 'Patients with squamous NSCLC, a performance status of 0 to 2, and normal organ function who had progressed\xa0after at least one prior platinum-based chemotherapy with cyclin-dependent kinase 4 gene (CDK4) or cyclin D1 gene (CCND1), cyclin D2 gene (CCND2), or cyclin D3 gene (CCND3) amplifications on tumor specimens were eligible', '32 eligible patients received', 'Positive Patients with Stage IV Squamous Cell Lung Cancer']","['docetaxel', 'palbociclib', 'SWOG S1400C (NCT02154490)-A', 'palbociclib with docetaxel']","['frequencies of cell cycle gene alterations', 'stable disease', 'median overall survival', 'median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0243037', 'cui_str': 'Cell Cycle Genes'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0246957', 'cui_str': 'Cyclin-Dependent Kinase 4'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0525036', 'cui_str': 'Genes, PRAD1'}, {'cui': 'C2718191', 'cui_str': 'Cyclin D2'}, {'cui': 'C0173532'}, {'cui': 'C0017256', 'cui_str': 'Gene Amplification'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0243037', 'cui_str': 'Cell Cycle Genes'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",32.0,0.0762491,"The median progression-free survival was 1.7 months (95% CI: 1.6-2.9 months) and the median overall survival was 7.1 months (95% CI: 4.2-12.5).
","[{'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania. Electronic address: Martin.edelman@fccc.edu.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistics and Data Management Center at Fred Hutchinson Cancer Reseach Center, Seattle, Washington.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, Illinois.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'McGary', 'Affiliation': 'Kaiser Permanente National Community Oncology Research Program/Kaiser Permanente Medical Group, Los Angeles, California.'}, {'ForeName': 'Noman M', 'Initials': 'NM', 'LastName': 'Rafique', 'Affiliation': 'Mercy Medical Center Tri-County Hematology/Oncology Association, Canton, Ohio.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Petro', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Saiama N', 'Initials': 'SN', 'LastName': 'Waqar', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Minichiello', 'Affiliation': 'SWOG Statistics and Data Management Center at Fred Hutchinson Cancer Reseach Center, Seattle, Washington.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistics and Data Management Center at Fred Hutchinson Cancer Reseach Center, Seattle, Washington.'}, {'ForeName': 'Vassiliki A', 'Initials': 'VA', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, California.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, California.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Medical Oncology, Yale Cancer Center, New Haven, Connecticut.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.06.027']
210,32312333,"Effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease: a double-blind randomised controlled clinical trial.","Non-alcoholic fatty liver disease (NAFLD) includes a range of disorders from simple steatosis to non-alcoholic steatohepatitis. There is no proven drug treatment for NAFLD, and diet modification is considered part of the main line of treatment for this disease. The aim of this study was to investigate the efficacy of garlic supplementation in NAFLD patients. The effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile was investigated in NAFLD patients. Ninety NAFLD patients were randomly assigned to take either a garlic powder supplement or a placebo for 12 weeks. The treatment group received four tablets of garlic daily (each tablet contained 400 mg garlic powder). The control group received four tablets of placebo (each placebo contained 400 mg starch). At the end of the study, hepatic steatosis was significantly reduced in the treatment group compared with the control group (P = 0·001). In addition, a significant decrease was seen in the serum concentration of alanine transaminase (P < 0·001), aspartate transaminase (P = 0·002), γ-glutamyltransferase (P = 0·003) as well as total cholesterol (P = 0·009), TAG (P < 0·001), HDL-cholesterol (P < 0·001) and LDL-cholesterol (P = 0·01) in the treatment group compared with the control group. No significant difference was seen between the two groups in serum concentration of alkaline phosphatase. Overall, garlic powder supplementation improved hepatic features and lipid profile among NAFLD patients.",2020,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"['NAFLD patients', 'Ninety NAFLD patients', 'patients with non-alcoholic fatty liver disease']","['garlic powder supplement or a placebo', 'garlic daily (each tablet contained 400 mg garlic powder', 'placebo (each placebo contained 400 mg starch', 'garlic powder supplementation', 'garlic supplementation']","['gamma-glutamyltransferase', 'total cholesterol', 'serum concentration of alkaline phosphatase', 'hepatic steatosis', 'high-density lipoprotein-cholesterol', 'hepatic features and lipid profile', 'serum concentration of alanine transaminase', 'triglyceride', 'low-density lipoprotein-cholesterol', 'aspartate transaminase', 'hepatic steatosis, liver enzymes, and lipid profile']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C1119842', 'cui_str': 'GARLIC POWDER'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}]",,0.54422,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Sangouni', 'Affiliation': 'Student Research Committee, Department of Nutrition, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hosseini Azar', 'Affiliation': 'Gastroenterology and Hepatology Subdivision of Internal Medicine Department, Imam Khomeini Hospital, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520001403']
211,31758523,"The effects of a comprehensive rehabilitation and intensive education program on anxiety, depression, quality of life, and major adverse cardiac and cerebrovascular events in unprotected left main coronary artery disease patients who underwent coronary artery bypass grafting.","OBJECTIVE


This study aimed to explore the effect of a comprehensive rehabilitation and intensive education (CRIE) program on anxiety, depression, quality of life (QoL), and major adverse cardiac and cerebrovascular events (MACCE) risk in unprotected left main coronary artery disease (ULMCAD) patients who underwent coronary artery bypass grafting (CABG).
METHODS


In total, 300 ULMCAD patients who underwent CABG were randomly assigned to the CRIE group or usual care (UC) group in a 1:1 ratio. During a 12-month intervention, anxiety and depression were evaluated by Hospital Anxiety and Depression Scale (HADS), QoL was evaluated by 12-Item Short-Form Health Survey (SF-12), on discharge day from hospital (M0), and at 3 months after the discharge (M3), M6, and M12. All patients were further followed up until occurrence of MACCE or for an additional 24 months, and MACCE accumulating occurrence rate was calculated.
RESULTS


At M12, HADS-anxiety score and anxiety prevalence (17.3% vs. 29.3%) were decreased in the CRIE group than those in the UC group, meanwhile HADS-depression score and depression prevalence (15.3% vs. 24.7%) were also reduced in the CRIE group than those in the UC group. For QoL, SF-12 Physical Component Summary (PCS) score at M6/M12, and SF-12 PCS score change (M12 - M0) were increased in the CRIE group than those in the UC group; meanwhile, SF-12 Mental Component Summary (MCS) score at M12 and SF-12 PCS score change (M12 - M0) were increased in the CRIE group than those in the UC group as well. Besides, MACCE accumulating occurrence rate was numerically lower in the CRIE group compared with that in the UC group but without statistical significance.
CONCLUSIONS


CRIE is an effective approach in improving anxiety, depression, and QoL in ULMCAD patients who underwent CABG.",2020,"At M12, HADS-anxiety score and anxiety prevalence (17.3% vs. 29.3%) were decreased in the CRIE group than those in the UC group, meanwhile HADS-depression score and depression prevalence (15.3% vs. 24.7%) were also reduced in the CRIE group than those in the UC group.","['ULMCAD patients who underwent CABG', 'unprotected left main coronary artery disease patients who underwent coronary artery bypass grafting', '300 ULMCAD patients who underwent CABG']","['CRIE group or usual care (UC', 'comprehensive rehabilitation and intensive education (CRIE) program', 'CRIE', 'coronary artery bypass grafting (CABG', 'comprehensive rehabilitation and intensive education program']","['For QoL, SF-12 Physical Component Summary (PCS) score at M6/M12, and SF-12 PCS score change (M12 - M0', 'meanwhile HADS-depression score and depression prevalence', 'HADS-anxiety score and anxiety prevalence', 'anxiety, depression, and QoL', 'MACCE accumulating occurrence rate', 'SF-12 Mental Component Summary (MCS) score at M12 and SF-12 PCS score change (M12 - M0', 'Hospital Anxiety and Depression Scale (HADS), QoL was evaluated by 12-Item Short-Form Health Survey (SF-12), on discharge day from hospital (M0), and at 3 months after the discharge (M3), M6, and M12', 'anxiety, depression, quality of life (QoL), and major adverse cardiac and cerebrovascular events (MACCE) risk', 'anxiety, depression, quality of life, and major adverse cardiac and cerebrovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1299433', 'cui_str': 'Left main coronary artery disease'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0241555,"At M12, HADS-anxiety score and anxiety prevalence (17.3% vs. 29.3%) were decreased in the CRIE group than those in the UC group, meanwhile HADS-depression score and depression prevalence (15.3% vs. 24.7%) were also reduced in the CRIE group than those in the UC group.","[{'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiovascular Surgery, The First Affiliated Hospital of Harbin Medical University, 23 Youzheng Street, Harbin, 150001, Heilongjiang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiovascular Surgery, The First Affiliated Hospital of Harbin Medical University, 23 Youzheng Street, Harbin, 150001, Heilongjiang, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiovascular Surgery, The First Affiliated Hospital of Harbin Medical University, 23 Youzheng Street, Harbin, 150001, Heilongjiang, China. Yuhui6677@126.com.'}]",Irish journal of medical science,['10.1007/s11845-019-02129-x']
212,31895722,Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence.,"OBJECTIVE


To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of nonsurgical therapies for fecal incontinence (FI).
METHODS


Women (N = 296) with FI were randomized to loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet in a 2 × 2 factorial design. Treatment response was defined in 3 ways from baseline to 24 weeks: minimal clinically important difference (MID) of -5 points in St. Mark's score, ≥50% reduction in FI episodes, and combined St. Mark's MID and ≥50% reduction FI episodes. Multivariable logistic regression models included baseline characteristics and treatment groups with and without controlling for drug and exercise adherence.
RESULTS


Treatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted odds ratio [aOR] 1.20, 95% confidence interval [CI] 1.11-1.28) and being overweight vs normal/underweight (aOR 2.15, 95% CI 1.07-4.34); these predictors remained controlling for adherence. Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score.
DISCUSSION


Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients, regarding efficacy and expectations of nonsurgical treatments of FI.",2020,"Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17).","['Women (N = 296) with FI', 'fecal incontinence (FI', 'Women Undergoing Nonsurgical Therapy for Fecal Incontinence']","['placebo', 'loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet']","[""FI episodes, and combined St. Mark's MID and ≥50% reduction FI episodes"", 'symptom severity', 'FI episodes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",,0.282172,"Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17).","[{'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': 'Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Iyer', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': 'Dell Medical School, Department of Obstetrics and Gynecology, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': 'Perelman School of Medicine, Department of Urology, University Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Bradley', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Pittsburgh, Magee-Women's Research Institute, Pittsburgh, Pennsylvania.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Harm-Ernandes', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, Duke University, Durham, North Carolina.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, California.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wohlrab', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver NICHD, Bethesda, Maryland.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000482']
213,32321718,Intratumoral Comparison of Nanoparticle Entrapped Docetaxel (CPC634) with Conventional Docetaxel in Patients with Solid Tumors.,"PURPOSE


CPC634 is a novel nanoparticle entrapping docetaxel, developed to enhance the intratumoral chemotherapy exposure. This randomized cross-over study compared the intratumoral and plasma pharmacokinetics of CPC634 with conventional docetaxel.
PATIENTS AND METHODS


Adult patients with solid tumors were randomized to receive CPC634 (75 mg/m 2 ) in cycle 1, and conventional docetaxel (75 mg/m 2 ) in cycle 2 or  vice versa . The study was powered to identify a 25% increase of intratumoral total docetaxel exposure after CPC634 infusion compared with conventional docetaxel. Four patients were allocated per tumor sampling time point, that is, 24, 48, 72, and 96 hours, 7 and 14 days after infusion during both cycles. Total docetaxel and released docetaxel from the nanoparticle were determined in tumor tissue derived from a metastatic lesion and in plasma. Pharmacokinetic data were analyzed using linear mixed modeling.
RESULTS


In total, 24 evaluable patients were included. In the tumor, CPC634 exhibited a 461% higher total docetaxel ( P  < 0.001) and a comparable released docetaxel concentration ( P  = 0.43). Plasma AUC inf  was 27% higher ( P  = 0.001) and  C   max  was 91% lower ( P  < 0.001) for CPC634 released docetaxel. The median observed neutrophil count nadir after conventional docetaxel treatment was lower (0.50 × 10 9 /L) compared with CPC634 (4.30 × 10 9 /L;  P  < 0.001).
CONCLUSIONS


Here, we demonstrated that CPC634 enhanced the intratumoral total docetaxel exposure compared with conventional docetaxel. The lower incidence of neutropenia during CPC634 treatment is presumably related to lower plasma  C   max  of released docetaxel. The unique pharmacokinetic profile of CPC634 nanoparticles has the potential to improve docetaxel treatment. A phase II efficacy trial of CPC634 is currently ongoing.",2020,In the tumor CPC634 exhibited a 461% higher total docetaxel ( P <0.001) and a comparable released docetaxel concentration ( P =0.43).,"['24 evaluable patients were included', 'Patients with Solid Tumors', 'Adult patients with solid tumors']","['Nanoparticle Entrapped Docetaxel (CPC634) with Conventional Docetaxel', 'conventional docetaxel (75 mg/m 2 ) in cycle 2 or  vice versa', 'CPC634', 'Total docetaxel and released docetaxel', 'conventional docetaxel', 'CPC634 with conventional docetaxel']","['Plasma AUC inf', 'neutropenia', 'median observed neutrophil count nadir', 'intratumoral total docetaxel exposure', 'total docetaxel', 'C max']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",4.0,0.0222535,In the tumor CPC634 exhibited a 461% higher total docetaxel ( P <0.001) and a comparable released docetaxel concentration ( P =0.43).,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Atrafi', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Ruben A G', 'Initials': 'RAG', 'LastName': 'van Eerden', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Marte A M', 'Initials': 'MAM', 'LastName': 'van Hylckama Vlieg', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Bruijn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Martijn P', 'Initials': 'MP', 'LastName': 'Lolkema', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Moelker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Cristianne J', 'Initials': 'CJ', 'LastName': 'Rijcken', 'Affiliation': 'Cristal Therapeutics, Maastricht, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hanssen', 'Affiliation': 'Cristal Therapeutics, Maastricht, the Netherlands.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sparreboom', 'Affiliation': 'Division of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Ferry A L M', 'Initials': 'FALM', 'LastName': 'Eskens', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands. s.koolen@erasmusmc.nl.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0008']
214,32321767,Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial.,"OBJECTIVE


The CIRCE trial (NCT01973101) investigated the efficacy, safety, and quality of life of the addition of neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation for locally advanced cervical cancer (stages IIB-IVA). The impact of both treatment arms on quality of life is reported in the present study.
METHODS


Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment. Linear mixed models were fitted to analyze differences in quality of life over time and between groups. Differences in mean quality of life scales >10 points and p<0.05 were considered clinically relevant and statistically significant, respectively. Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire. Excluded were patients who did not complete any quality of life questionnaire. Relevant exclusion criteria for the CIRCE trial included Eastern Cooperative Oncology Group performance status >2 and peripheral neuropathy >2. Mann-Whitney U tests were performed to assess differences between groups in quality of life at baseline. To evaluate differences between treatment arms, linear mixed models were fitted using the transformed quality of life scores as a dependent variable and time of follow-up and study arm as factors.
RESULTS


A total of 107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm). Quality of life compliance rates were higher for the chemoradiation group at every assessment time (ranging from 75-86.5% in the chemoradiation arm vs 55-81.8% in the neoadjuvant chemotherapy arm). For quality of life results at baseline, no statistically significant difference between the groups was seen. For both groups, most scales showed improvements over time, except for worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms. For chemoradiation, body image was lower (p<0.001) and patients presented more lymphedema (p<0.001) and sexual worry (p<0.001) at 12 months compared with baseline. Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01). At 12 months, clinical differences were seen only for body image and menopausal symptoms scale, with neoadjuvant chemotherapy presenting better body image scores and a lower burden of menopausal symptoms.
CONCLUSION


After treatment for locally advanced cervical cancer, patients improved in most quality of life aspects. However, worsening was observed in sexual enjoyment, peripheral neuropathy, and menopausal symptoms. To improve patients' quality of life, efforts should be made to prevent and treat these long term effects of locally advanced cervical cancer treatment.",2020,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","['Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire', 'locally advanced cervical cancer (stages IIB-IVA', '107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm', 'Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment', 'locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial']","['neoadjuvant chemotherapy', 'neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation']","['Quality of life', 'sexual/vaginal functioning', 'Quality of life compliance rates', 'menopausal symptoms scale', 'quality of life questionnaire', 'mean quality of life scales', 'body image and menopausal symptoms scale', 'worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'quality of life', 'lymphedema (p<0.001) and sexual worry', 'efficacy, safety, and quality of life']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424403', 'cui_str': 'Erotic feeling'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",107.0,0.0959925,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Nunes de Arruda', 'Affiliation': 'Sao Paulo University Faculty of Medicine, Sao Paulo, Brazil fernanda.arruda@fm.usp.br.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'da Costa', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Bonadio', 'Affiliation': 'Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Abraão', 'Initials': 'A', 'LastName': 'Dornellas', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pereira', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'Epidemiology, University of Groningen Faculty of Medical Sciences, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Pilar Estevez Diz', 'Affiliation': 'Radiology and Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001134']
215,32319039,Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review.,"Migraine is a debilitating neurologic disease. People who experience migraine can have substantial disability, impaired functioning and a decreased quality of life (QoL). Expert recommendations suggest that people with frequent migraine attacks or severe impairment related to attacks may benefit from preventive treatment. Despite these recommendations and the existence of evidence-based guidelines for the use of preventive medication, many people who are candidates for preventive therapies do not receive them. Thus, there is still a substantial unmet need for preventive migraine treatment. Calcitonin gene-related peptide (CGRP) has a demonstrated role in the pathophysiology of migraine. Galcanezumab-gnlm (galcanezumab) is a humanized monoclonal antibody that binds to the CGRP ligand and prevents binding to its receptor. It is administered as a once-monthly subcutaneous injection. The aim of this review is to present a comprehensive overview of the existing short- and long-term efficacy and safety data for galcanezumab in patients with migraine. Data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2 and REGAIN studies show that galcanezumab treatment for 3 or 6 months results in overall reduction in mean monthly migraine headache days in patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine. Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning. A 12-month open-label study demonstrated the continued efficacy of galcanezumab for up to 12 months. In all studies galcanezumab was well tolerated. In conclusion, data from pivotal studies show that galcanezumab may fulfill an unmet need in the treatment of patients with migraine who require preventive therapy.",2020,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","['patients with migraine', 'patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine', 'patients with migraine who require preventive therapy', 'Migraine']","['Calcitonin gene-related peptide (CGRP', 'Migraine', 'Galcanezumab-gnlm (galcanezumab', 'galcanezumab', 'placebo', 'galcanezumab versus placebo', 'Galcanezumab']","['Efficacy and Safety', 'quality of life (QoL', 'level of disability', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C4731561', 'cui_str': 'galcanezumab-gnlm'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0581009,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Martin', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Karen Hamrick', 'Initials': 'KH', 'LastName': 'Samaan', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA. karen.samaan@lilly.com.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pallay', 'Affiliation': 'Department of Family Medicine, Mercer University School of Medicine, Savannah, GA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01319-9']
216,32298326,Socio-ecological correlates of physical activity in breast and colon cancer survivors 4 years after participation in a randomized controlled exercise trial (PACT study).,"BACKGROUND


Having a physically active lifestyle after cancer diagnosis is beneficial for health, and this needs to be continued into survivorship to optimize long-term benefits. We found that patients, who participated in an 18-week exercise intervention, reported significant higher physical activity (PA) levels 4 years after participation in a randomized controlled trial of supervised exercise delivered during chemotherapy (PACT study). This study aimed to identify social-ecological correlates of PA levels in breast and colon cancer survivors 4 years after participation in the PACT study.
METHODS


Self-reported PA levels and potential correlates (e.g. physical fitness, fatigue, exercise history, and built environment) were assessed in 127 breast and colon cancer survivors shortly after diagnosis (baseline), post-intervention and 4 years later. Multivariable linear regression analyses were performed to identify social-ecological correlates of PA 4 years post-baseline.
RESULTS


The final model revealed that lower baseline physical fatigue (β = -0.25, 95% CI -0.26; -0.24) and higher baseline total PA (0.06, 95% CI, 0.03; 0.10) were correlated with higher total PA levels 4 years post-baseline. Higher baseline leisure and sport PA (0.02, 95% CI 0.01; 0.03), more recreational facilities within a buffer of 1 km (4.05, 95% CI = 1.28; 6.83), lower physical fatigue at 4-year follow-up (-8.07, 95% CI -14.00; -2.13), and having a positive change in physical fatigue during the intervention period (0.04, 95% CI 0.001; 0.07) were correlates of sport and leisure PA levels 4 years post-baseline.
CONCLUSIONS


This study suggests that baseline and 4-year post-baseline physical fatigue, and past exercise behaviour, were significant correlates of PA 4 years after participation in an exercise trial. Additionally, this study suggests that the built environment should be taken into account when promoting PA. Understanding of socio-ecological correlates of PA can provide insights into how future exercise interventions should be designed to promote long-term exercise behaviour.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on 9 December 2009, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2138.",2020,"Higher baseline leisure and sport PA (0.02, 95% CI 0.01; 0.03), more recreational facilities within a buffer of 1 km (4.05, 95% CI = 1.28; 6.83), lower physical fatigue at 4-year follow-up (","['breast and colon cancer survivors 4 years after participation in the PACT study', 'breast and colon cancer survivors 4 years after participation', '127 breast and colon cancer survivors shortly after diagnosis (baseline), post-intervention and 4 years later']","['supervised exercise delivered during chemotherapy', '18-week exercise intervention']","['physical activity (PA) levels', 'lower physical fatigue', 'recreational facilities', 'total PA levels', 'baseline total PA', 'baseline physical fatigue', 'PA levels and potential correlates (e.g. physical fitness, fatigue, exercise history, and built environment', 'physical fatigue']","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442550', 'cui_str': 'Recreational facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0457992', 'cui_str': 'Exercise history'}, {'cui': 'C4505382', 'cui_str': 'Built Environment'}]",,0.137861,"Higher baseline leisure and sport PA (0.02, 95% CI 0.01; 0.03), more recreational facilities within a buffer of 1 km (4.05, 95% CI = 1.28; 6.83), lower physical fatigue at 4-year follow-up (","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Petra H M', 'Initials': 'PHM', 'LastName': 'Peeters', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Jansen', 'Affiliation': 'Department of Human Geography and Spatial Planning, Faculty of Geosciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Elsken', 'Initials': 'E', 'LastName': 'van der Wall', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Frank J G', 'Initials': 'FJG', 'LastName': 'Backx', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science & Sport, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Miranda J', 'Initials': 'MJ', 'LastName': 'Velthuis', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0231663']
217,32316856,Outcomes of Therapeutic Artmaking in Patients Undergoing Radiation Oncology Treatment: A Mixed-Methods Pilot Study.,"A cancer diagnosis can be extremely stressful and life-altering for patients. Chronically high levels of stress can increase inflammation and affect the progression of the cancer. Psychosocial interventions could reduce stress and address cancer patients' emotional, psychological, and spiritual needs. This mixed-methods pilot study compared 2 single-session arts-based approaches for patients in active radiation treatment in a large urban hospital. Participants were assigned to either the active control of independent coloring or the therapeutic intervention of open studio art therapy. Participants completed pre-session and post-session saliva samples and standardized psychosocial measures of stress, affect, anxiety, self-efficacy, and creative agency. Both conditions significantly increased participants' positive affect, self-efficacy, and creative agency, and decreased negative affect, perceived stress, and anxiety. No changes of note were seen in the salivary measures. Participants' narrative responses corroborated the quantitative findings and highlighted additional benefits such as supporting meaning-making and spiritual insights. Both arts-based interventions can support the emotional, psychological, and spiritual needs of cancer patients while each has features that may be more suited to the needs of certain patients. Further replication of these findings could support our initial findings that suggest that patients could benefit from having art studio spaces with art therapists and choices of art materials available on the oncology unit.",2020,"Both conditions significantly increased participants' positive affect, self-efficacy, and creative agency, and decreased negative affect, perceived stress, and anxiety.","['Patients Undergoing Radiation Oncology Treatment', 'patients in active radiation treatment in a large urban hospital']","['active control of independent coloring or the therapeutic intervention of open studio art therapy', 'Psychosocial interventions']","[""participants' positive affect, self-efficacy, and creative agency, and decreased negative affect, perceived stress, and anxiety"", 'standardized psychosocial measures of stress, affect, anxiety, self-efficacy, and creative agency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522449', 'cui_str': 'Radiation therapy procedure or service'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",2.0,0.0580985,"Both conditions significantly increased participants' positive affect, self-efficacy, and creative agency, and decreased negative affect, perceived stress, and anxiety.","[{'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Kaimal', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Carroll-Haskins', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Janell L', 'Initials': 'JL', 'LastName': 'Mensinger', 'Affiliation': 'Villanova University, Villanova, PA, USA.'}, {'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Dieterich-Hartwell', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Jacelyn', 'Initials': 'J', 'LastName': 'Biondo', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Levin', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}]",Integrative cancer therapies,['10.1177/1534735420912835']
218,32316864,Amazake made from sake cake and rice koji suppresses sebum content in differentiated hamster sebocytes and improves skin properties in humans.,"Amazake is a traditional Japanese health drink. Here, we examined the effects of amazake on skin in cells and humans. Treatment with sake cake or rice koji suppressed intracellular lipid accumulation in differentiated hamster sebocytes, likely through the reduced expression of peroxisome proliferator-activated receptor-gamma (PPARγ) mRNA. In double-blind, placebo-controlled trial, seventeen Japanese women ingested either amazake or placebo for 4 weeks. Ingestion of the amazake decreased the sebum content compared to the placebo. The questionnaires showed improvements in ""face color,"" ""dark circles under the eyes,"" ""glossy hair,"" and ""waking up well"", only in the amazake. In accordance with the questionnaires, additional analysis revealed the change in the L* values under the eyes was statistically increased in the amazake compared to the placebo. These results indicate that amazake may decrease sebum content in cells and humans and increase the L* values under the eyes, with some additional beneficial effects in humans.",2020,Ingestion of the amazake decreased the sebum content compared to the placebo.,['seventeen Japanese women ingested either'],"['amazake', 'amazake or placebo', 'sake cake or rice koji', 'placebo']","['skin properties', 'sebum content', 'intracellular lipid accumulation', 'face color,"" ""dark circles under the eyes,"" ""glossy hair,"" and ""waking up well']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452597', 'cui_str': 'Cake'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0442696', 'cui_str': 'Waking'}]",17.0,0.0923512,Ingestion of the amazake decreased the sebum content compared to the placebo.,"[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Maruki-Uchida', 'Affiliation': 'Health Science Research Center, R&D Institute, Morinaga and Company Limited , Yokohama, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Sai', 'Affiliation': 'Health Science Research Center, R&D Institute, Morinaga and Company Limited , Yokohama, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Yano', 'Affiliation': 'Yaesu Nihonbashi Skin Clinic , Tokyo, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Health Science Research Center, R&D Institute, Morinaga and Company Limited , Yokohama, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'School of Bioscience and Biotechnology, Tokyo University of Technology , Hachioji, Tokyo, Japan.'}]","Bioscience, biotechnology, and biochemistry",['10.1080/09168451.2020.1756734']
219,32311162,Aggressive lymphoma subtype is a risk factor for venous thrombosis. Development of lymphoma - specific venous thrombosis prediction models.,"Venous thromboembolic events (VTE) are a frequent complication of lymphoma. We conducted a retrospective analysis to compare VTE risk in diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Subjects were randomly assigned to training and validation sets to identify risk factors of VTE and evaluate risk model performance, including the Khorana score. A group of 790 patients were diagnosed from 2002 to 2014 (DLBCL = 542, FL = 248). Median follow- up was 49 months. We observed 106 VTE, with higher incidence in DLBCL (5-year cumulative incidence = 16.3% vs 3.8% in FL patients). Five-year OS for patients with VTE was 51.4% vs 73.1% in patients without VTE (P < .001). Baseline VTE risk factors identified in the training cohort included lymphoma subtype, previous VTE, ECOG performance status ≥2, decreased albumin, increased calcium, elevated WBC, absolute lymphocyte count or monocyte count, and presence of bulky disease. Addition of new variables to the Khorana score improved its performance measured by Akaike information criterion and Concordance index. A new risk model including lymphoma subtype, albumin, WBC count, and bulky disease was validated in time-based ROC analyses. These findings were confirmed in the validation cohort. Lymphoma subtypes have different VTE risk. The effect of lymphoma subtype was independent from disease burden and the use of systemic therapy. The Khorana risk-score was validated in time to event analyses, and a more robust lymphoma-specific VTE risk score is proposed. These findings suggest lymphoma patients with highest VTE risk can be identified with baseline parameters.",2020,Addition of new variables to the Khorana score improved its performance measured by Akaike information criterion and Concordance index.,['diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL'],[],"['Khorana risk-score', 'calcium, elevated WBC, absolute lymphocyte count or monocyte count, and presence of bulky disease', 'lymphoma subtype, albumin, WBC count, and bulky disease', 'Venous thromboembolic events (VTE']","[{'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",,0.0310593,Addition of new variables to the Khorana score improved its performance measured by Akaike information criterion and Concordance index.,"[{'ForeName': 'Gouri', 'Initials': 'G', 'LastName': 'Dharmavaram', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Shufen', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Sundaram', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA.'}, {'ForeName': 'Sabarish', 'Initials': 'S', 'LastName': 'Ayyappan', 'Affiliation': 'Division of Hematology, Oncology and Bone & Marrow Transplantation, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Boughan', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Gallogly', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Malek', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Leland', 'Initials': 'L', 'LastName': 'Metheny', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tomlinson', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Folashade', 'Initials': 'F', 'LastName': 'Otegbeye', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Hillard M', 'Initials': 'HM', 'LastName': 'Lazarus', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Pingfu', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'de Lima', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Paolo F', 'Initials': 'PF', 'LastName': 'Caimi', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}]",American journal of hematology,['10.1002/ajh.25837']
220,32311166,Can we harness the placebo effect to improve care in lower urinary tract dysfunction? ICI-RS 2019.,"The proposal ""Can we harness the placebo effect to improve care in lower urinary tract dysfunction?"" was discussed at the International Consultation on Incontinence-Research Society (ICI-RS) 2019 meeting. The placebo effect can change the treatment outcome whether the treatment is an active treatment or placebo. The total active treatment outcome is a combination of the placebo and the active treatment effect which is seen in placebo-controlled trials. The placebo effect plays an important role in the treatment of lower urinary tract dysfunction in overactive bladder, bladder pain syndrome, and stress urinary incontinence. In clinical practice, a number of factors can be employed to use the placebo effect to maximize its effect on patients receiving an active treatment, such as having the same environment for review such as the same appointment time, same room, and same clinician. Clinicians should also be aware of the nocebo effect which is increased with an overemphasis on side effects or negative outcomes.",2020,"The placebo effect plays an important role in the treatment of lower urinary tract dysfunction in overactive bladder, bladder pain syndrome, and stress urinary incontinence.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.155718,"The placebo effect plays an important role in the treatment of lower urinary tract dysfunction in overactive bladder, bladder pain syndrome, and stress urinary incontinence.","[{'ForeName': 'Vik', 'Initials': 'V', 'LastName': 'Khullar', 'Affiliation': ""Urogynaecology Department, St Mary's Hospital, Imperial College London, London, UK.""}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': ""Rahnama'i"", 'Affiliation': 'Department of Urology, University Hospital Maastricht, Maastricht, The Netherlands.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Veit-Rubin', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cardozo', 'Affiliation': 'Department of Urogynaecology, Kings College Hospital, London, UK.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': 'Department of Urology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Neurourology and urodynamics,['10.1002/nau.24351']
221,32312606,"Classification-Specific Treatment Improves Pain, Disability, Fear-Avoidance Beliefs, and Erector Spinae Muscle Activity During Walking in Patients With Low Back Pain Exhibiting Lumbar Extension-Rotation Pattern: A Randomized Controlled Trial.","OBJECTIVE


Low back pain (LBP) has commonly been managed via classification-specific interventions in homogeneous groups. However, it is largely unknown whether treatment tailored to specific classifications is more effective than generic treatment. The purpose of this study was to evaluate the effects of classification-specific treatment on the self-reported responses and erector spinae (ES) activity of patients with LBP exhibiting a lumbar extension-rotation (ExtRot) pattern.
METHODS


In total, 39 patients exhibiting the lumbar ExtRot pattern were randomized to an experimental (n = 19) group and a control (n = 20) group. Participants in the experimental group received classification-specific treatment, which included exercise to control or prevent lumbopelvic motion during lower-extremity movement. Participants in the control group were encouraged to perform general exercises and were educated about LBP. Patient-reported pain intensity, disability, and fear-avoidance belief and ES muscle activity during walking were assessed prior to and after the intervention. Two-way analysis of covariance was used to examine the effects of classification-specific treatment.
RESULTS


After 6-week intervention, significant time-by-group interaction effects were demonstrated on pain intensity, disability, fear-avoidance beliefs-physical activity score, and ES muscle activity during walking. There were significant effects of group on pain, disability, and fear-avoidance beliefs-physical activity score after intervention. After the 6-week intervention, the ES muscle activity significantly decreased in the experimental group during walking, but does not represent an all-events decrease.
CONCLUSION


Classification-specific treatment may be effective in patients with LBP exhibiting the lumbar ExtRot pattern, reducing pain intensity, disability, fear-avoidance beliefs, and ES muscle activity during walking.",2020,"After 6-week intervention, significant time-by-group interaction effects were demonstrated on pain intensity, disability, fear-avoidance beliefs-physical activity score, and ES muscle activity during walking.","['patients with LBP exhibiting the lumbar ExtRot pattern', '39 patients exhibiting the lumbar ExtRot pattern', 'patients with LBP exhibiting a lumbar extension-rotation (ExtRot) pattern', 'Patients With Low Back Pain Exhibiting Lumbar Extension-Rotation Pattern']","['classification-specific treatment, which included exercise to control or prevent lumbopelvic motion during lower-extremity movement']","['Pain, Disability, Fear-Avoidance Beliefs, and Erector Spinae Muscle Activity', 'ES muscle activity', 'pain intensity, disability, fear-avoidance beliefs, and ES muscle activity', 'pain, disability, and fear-avoidance beliefs-physical activity score', 'pain intensity, disability, fear-avoidance beliefs-physical activity score, and ES muscle activity during walking', 'pain intensity, disability, and fear-avoidance belief and ES muscle activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",39.0,0.0328917,"After 6-week intervention, significant time-by-group interaction effects were demonstrated on pain intensity, disability, fear-avoidance beliefs-physical activity score, and ES muscle activity during walking.","[{'ForeName': 'Si-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Sangji University, Wonju-si, Gangwon-do, South Korea.'}, {'ForeName': 'Kyue-Nam', 'Initials': 'KN', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Jeonju University, Jeonju-si, Jeonrabuk-do, South Korea.'}, {'ForeName': 'Oh-Yun', 'Initials': 'OY', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, Yonsei University, Wonju-si, Gangwon-Do, South Korea. Electronic address: kwonoy@yonsei.ac.kr.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.04.004']
222,32312607,Changes in Vertebral Arterial Blood Flow During Premanipulative Tests in Participants With Upper Cervical Spine Motion Restriction.,"OBJECTIVE


The purpose of the present study was to measure changes in blood flow velocity and volume flow rate (VFR) in the contralateral vertebral artery (VA) during end-range rotation and pre-manipulative hold at C1-C2 and to compare these measurements between participants with and without C1-C2 range of motion (ROM) restriction.
METHODS


This research was approached as an exploratory study and designed as a parallel noninterventional controlled trial with intentionally equal allocation, for studying diagnostic tests. Fifteen women and 13 men (mean age 44) were recruited (volunteer sample) in physiotherapy clinics. No participant had any current neurologic or vertebrobasilar insufficiency symptoms. The measurements of 13 participants with a limited ROM C1-C2 and 15 with no limitation were compared. Blood flow velocity and VFR in the contralateral VA were measured using color duplex Doppler imaging in 3 neck positions: neutral, maximal rotation, and pre-manipulative hold of C1-C2.
RESULTS


Pre-manipulative hold significantly (P < .01) decreased all blood flow velocity parameters and VFR, mainly in the left VA. End-range rotation showed a significant (P < .05) decrease in the peak systolic velocity in the left VA. No significant differences were found between participants grouped by the presence or absence of a C1-C2 ROM restriction.
CONCLUSION


A C1-C2 rotational ROM restriction does not appear associated with change in a significantly reduced VA blood flow due to the neck position.",2020,"RESULTS


Pre-manipulative hold significantly (P < .01) decreased all blood flow velocity parameters and VFR, mainly in the left VA.","['participants with and without C1-C2 range of motion (ROM) restriction', '13 participants with a limited ROM C1-C2 and 15 with no limitation were compared', 'Participants With Upper Cervical Spine Motion Restriction', 'Fifteen women and 13 men (mean age 44) were recruited (volunteer sample) in physiotherapy clinics']",[],"['peak systolic velocity', 'Vertebral Arterial Blood Flow', 'blood flow velocity parameters and VFR', 'blood flow velocity and volume flow rate (VFR', 'Blood flow velocity and VFR', 'current neurologic or vertebrobasilar insufficiency symptoms']","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0231589', 'cui_str': 'Limitation of joint movement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}]",[],"[{'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0042568', 'cui_str': 'Vertebrobasilar artery syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",15.0,0.0371664,"RESULTS


Pre-manipulative hold significantly (P < .01) decreased all blood flow velocity parameters and VFR, mainly in the left VA.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Leenaerts', 'Affiliation': 'Paramedisch Instituut Scheepjeshof, Veenendaal, The Netherlands. Electronic address: a.e.r.leenaerts@live.nl.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Molenaar', 'Affiliation': 'Fysiogroep Waterland, Monnickendam, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Cattrysse', 'Affiliation': 'Experimental Anatomy research group, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.10.002']
223,32125256,Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial.,"Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants ( P  < .001). Freedom from TLR occurred in 97.2% (95% CI: 89.1%, 99.3%) of DCB angioplasty and 78% (95% CI: 66.5%, 86.0%) of conventional balloon angioplasty participants ( P  = .001). The groups did not differ in sustained improvement from baseline to 2 years in Rutherford-Becker category (row mean scores difference, 1.7;  P  = .19) and showed no difference in mean improvement in the Walking Impairment Questionnaire score (-0.8%; 95% CI: -11.8%, 10.2%;  P  = .88), EuroQol Group's five-dimension index of quality of life (-0.06; 95% CI: -0.17, 0.03;  P  = .20), or ankle-brachial index (0.03; 95% CI: -0.08, 0.14;  P  = .57). No major amputation was necessary. One DCB angioplasty and two conventional balloon angioplasty participants died (risk ratio, 0.48; 95% CI: 0.04, 5.10). Conclusion At 2 years after paclitaxel drug-coated balloon (DCB) angioplasty, primary patency and freedom from target lesion revascularization remained superior compared with conventional balloon angioplasty. DCB angioplasty resulted in sustained clinical and hemodynamic improvement with no increased risk of mortality. © RSNA, 2020  Online supplemental material in available for this article.",2020,"At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants ( P  < .001).","['A total of 171 participants (mean age, 69 years ± 8; 111 men', 'consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016']","['conventional balloon angioplasty', 'paclitaxel drug-coated balloon (DCB) angioplasty', 'DCB angioplasty or conventional balloon angioplasty', 'Drug-coated Balloon Angioplasty of Femoropopliteal Lesions', 'DCB) catheter angioplasty', 'DCB angioplasty', ' Paclitaxel drug-coated balloon', 'Conventional Balloon']","['TLR', '2-year efficacy and safety', 'ankle-brachial index', 'primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality', 'risk of mortality', 'primary patency', 'dimension index of quality of life', '6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty', 'Walking Impairment Questionnaire score']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0032649', 'cui_str': 'Popliteal Artery'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0034380'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",171.0,0.256992,"At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants ( P  < .001).","[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Aschenbach', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Dierk', 'Initials': 'D', 'LastName': 'Scheinert', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Brechtel', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Blessing', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lichtenberg', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Flotow', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Heilmeier', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Sixt', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Brucks', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Erbel', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beschorner', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Werk', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Riambau', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wienke', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Christof Tobias', 'Initials': 'CT', 'LastName': 'Klumb', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Thieme', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).'}]",Radiology,['10.1148/radiol.2020191619']
224,31996179,Violence against children and intimate partner violence against women: overlap and common contributing factors among caregiver-adolescent dyads.,"BACKGROUND


Intimate partner violence against women (IPV) and violence against children (VAC) are both global epidemics with long-term health consequences. The vast majority of research to date focuses on either IPV or VAC, however the intersections between these types of violence are a growing area of global attention. A significant need exists for empirical research on the overlap of IPV and VAC, especially in contexts with particularly high rates of both types of violence.
METHODS


This exploratory study includes secondary analysis of data from a cluster randomized controlled trial in Ugandan schools. Using baseline reports from a random sample of early adolescents attending school and their caregivers, this study uses a probability sample across all eligible schools of adolescent-caregiver dyads (n = 535). We categorized adolescent-caregiver dyads into four groups: those reporting VAC 'only', IPV 'only', both VAC and IPV, or 'no violence'. Two separate multinomial logistic regression models for male and female caregivers explored adolescent and caregiver characteristics associated with the VAC 'only', the IPV 'only', or the both VAC and IPV dyads, each compared to the 'no violence' dyad.
RESULTS


One third of dyads reported both IPV and VAC and nearly 75% of dyads reported VAC or IPV. Dyads reporting IPV were more likely to also report VAC. Common contributing factors for female caregiver-adolescent dyads with both VAC and IPV include lower SES, less caregiver education, higher caregiver mental distress, more frequent caregiver alcohol use, and caregivers who report less emotional attachment to their intimate partner. Male caregiver-adolescent dyads with both VAC and IPV included caregivers with less emotional attachment to their intimate partner and more attitudes accepting VAC.
CONCLUSIONS


Findings reveal a significant overlap of IPV and VAC and the importance for violence prevention and response programming to consider coordinated or integrated programming. Unique results for female and male caregivers highlight the importance of a gendered approach to addressing IPV and VAC intersections.
TRIAL REGISTRATION


The trial was registered at clinicaltrials.gov, NCT01678846, on September 5, 2012.",2020,"Two separate multinomial logistic regression models for male and female caregivers explored adolescent and caregiver characteristics associated with the VAC 'only', the IPV 'only', or the both VAC and IPV dyads, each compared to the 'no violence' dyad.
","['Male caregiver-adolescent dyads with both VAC and IPV included caregivers with less emotional attachment to their intimate partner and more attitudes accepting VAC', 'female caregiver-adolescent dyads', 'Violence against children and intimate partner violence against women', 'Ugandan schools', ""categorized adolescent-caregiver dyads into four groups: those reporting VAC 'only', IPV 'only', both VAC and IPV, or 'no violence"", 'Intimate partner violence against women (IPV) and violence against children (VAC', 'early adolescents attending school and their caregivers, this study uses a probability sample across all eligible schools of adolescent-caregiver dyads (n\u2009=\u2009535', 'female and male caregivers']",[],['caregiver mental distress'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0557295', 'cui_str': 'Attending school (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0033206', 'cui_str': 'Probability Sample'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0235109', 'cui_str': 'Mental distress (finding)'}]",,0.0695783,"Two separate multinomial logistic regression models for male and female caregivers explored adolescent and caregiver characteristics associated with the VAC 'only', the IPV 'only', or the both VAC and IPV dyads, each compared to the 'no violence' dyad.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Carlson', 'Affiliation': 'University of Alabama, School of Social Work, 3026 Little Hall, Box 870314, Tuscaloosa, AL, 35487-0314, USA. ccarlson5@ua.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Namy', 'Affiliation': 'Raising Voices, Kampala, Uganda.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norcini Pala', 'Affiliation': 'Columbia University, Social Intervention Group, New York, USA.'}, {'ForeName': 'Milton L', 'Initials': 'ML', 'LastName': 'Wainberg', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Michau', 'Affiliation': 'Raising Voices, Kampala, Uganda.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Nakuti', 'Affiliation': 'Raising Voices, Kampala, Uganda.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Knight', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Carin', 'Initials': 'C', 'LastName': 'Ikenberg', 'Affiliation': 'University of Alabama, School of Social Work, 3026 Little Hall, Box 870314, Tuscaloosa, AL, 35487-0314, USA.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Naker', 'Affiliation': 'Raising Voices, Kampala, Uganda.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Devries', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}]",BMC public health,['10.1186/s12889-019-8115-0']
225,31389049,"Phylogenetic characterization of rhinoviruses from infants in Sarlahi, Nepal.","PROBLEM


Rhinoviruses (RVs), the most common causes of acute respiratory infections in young children and infants, are highly diverse genetically.
OBJECTIVE


To characterize the RV types detected with respiratory illness episodes in infants in Nepal.
STUDY METHODS


Infants born to women enrolled in a randomized trial of maternal influenza immunization in rural, southern Nepal were followed with household-based weekly surveillance until 180 days of age. Infants with respiratory symptoms had nasal swabs tested for twelve respiratory viruses. A subset with RV alone was selected for sequencing of the VP4/2 gene to identify RV types.
RESULTS


Among 547 RV-only positive illnesses detected from December 2012 to April 2014, 285 samples (52%) were sequenced. RV-A, B, and C species were detected in 193 (68%), 18 (6%), and 74 (26%) specimens, respectively. A total of 94 unique types were identified from the sequenced samples, including 52 RV-A, 11 RV-B, and 31 RV-C. Multiple species and types circulated simultaneously throughout the study period. No seasonality was observed. The median ages at illness onset were 88, 104, and 88 days for RV-A, B, and C, respectively. The median polymerase chain reaction cycle threshold values did not differ between RV species. No differences between RV species were observed for reported respiratory symptoms, including pneumonia, or for medical care-seeking.
CONCLUSIONS


Among very young, symptomatic infants in rural Nepal, all three species and many types of RV were identified; RV-A was detected most frequently. There was no association between RV species and disease severity.",2019,"No differences between RV species were observed for reported respiratory symptoms, including pneumonia, or for medical care-seeking.
","['young children and infants', 'Infants with respiratory symptoms had nasal swabs tested for twelve respiratory viruses', 'rhinoviruses from infants in Sarlahi, Nepal', 'infants in Nepal', 'Infants born to women enrolled in a randomized trial of maternal influenza immunization in rural, southern Nepal were followed with household-based weekly surveillance until 180 days of age']",[],"['RV-A, B, and C species', 'median polymerase chain reaction cycle threshold values', 'RV species and disease severity', 'respiratory symptoms, including pneumonia, or for medical care-seeking']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0597404', 'cui_str': 'Respiratory viruses'}, {'cui': 'C0035473', 'cui_str': 'Rhinovirus'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",,0.0364988,"No differences between RV species were observed for reported respiratory symptoms, including pneumonia, or for medical care-seeking.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kuypers', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Garrett A', 'Initials': 'GA', 'LastName': 'Perchetti', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Kira L', 'Initials': 'KL', 'LastName': 'Newman', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project, Kathmandu, Nepal.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Jerome', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, George Washington University, Washington, District of Colombia.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""Seattle Children's Hospital and Research Foundation, Seattle, Washington.""}]",Journal of medical virology,['10.1002/jmv.25563']
226,32316158,Effects of a Workplace-Based Virtual-Run Intervention Among University Employees.,"Virtual runs (real running or walking activities using online recording platforms) have been popular in the digital age and could have the potential to promote physical activity (PA) in workplaces. We investigated the effects of a virtual-run intervention (VRI) on PA and body compositions among university employees. A three-phase intervention was conducted over 6 months: 0 (pre-intervention), 1 (during intervention), and 2 (post-intervention). Exercise stages of change were assessed in phases 0 and 2. Body compositions (body weight, body mass index, fat mass, percentage of fat mass, fat-free mass, and percentage of fat-free mass) were assessed in phases 0, 1, and 2. Running and walking times were recorded through a mobile application. Forty-seven participants completed the VRI. The number of participants at the maintenance stage increased from 34.04% in phase 0 ( n  = 16) to 63.83% in phase 2 ( n  = 30). None of the changes in body compositions were significant ( p  > 0.05). The median running and walking time among participants at the maintenance stage was 151.85 (interquartile range, 109.15) min/week. Future research should focus on approaches to improve the efficacy of VRIs and their effects on health outcomes.",2020,None of the changes in body compositions were significant ( p  > 0.05).,"['university employees', 'University Employees']","['Workplace-Based Virtual-Run Intervention', 'virtual-run intervention (VRI', 'Virtual runs (real running or walking activities using online recording platforms']","['Body compositions (body weight, body mass index, fat mass, percentage of fat mass, fat-free mass, and percentage of fat-free mass', 'median running and walking time', 'body compositions']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",47.0,0.0386114,None of the changes in body compositions were significant ( p  > 0.05).,"[{'ForeName': 'Apichai', 'Initials': 'A', 'LastName': 'Wattanapisit', 'Affiliation': 'School of Medicine, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Waluka', 'Initials': 'W', 'LastName': 'Amaek', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Watcharawat', 'Initials': 'W', 'LastName': 'Promma', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Phatcharawadee', 'Initials': 'P', 'LastName': 'Srirug', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Uchane', 'Initials': 'U', 'LastName': 'Cheangsan', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Satit', 'Initials': 'S', 'LastName': 'Khwanchum', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Wattana', 'Initials': 'W', 'LastName': 'Chadakorn', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Kanittha', 'Initials': 'K', 'LastName': 'Eardmak', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Narumon', 'Initials': 'N', 'LastName': 'Chadakorn', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17082745']
227,32316197,Effectiveness of Motivational Interviewing in Regard to Activities of Daily Living and Motivation for Rehabilitation among Stroke Patients.,"BACKGROUND


Stroke patients urgently need rehabilitation to enhance activities of daily living. This study aims to determine whether motivational interviewing (MI) improves the performance of activities of daily living and enhances motivation for rehabilitation among first-stroke patients.
METHODS


A quasi-experimental design was used in this study. The study recruited 65 patients between March and October 2016. Before the intervention, all patients received routine care. The experimental group (n = 33) received weekly sessions of MI for 6 weeks, whereas the control group (n = 32) received individual attention from a research nurse weekly for 6 weeks. Structured questionnaires were used to collect data, including demographic data, activities of daily living data (Barthel index {BI} and instrumental activities of daily living {IADLs} scale), and rehabilitation motivation data.
RESULTS


The BI and IADLs scores significantly improved with time in both the experimental and control groups. The generalized estimating equation approach showed that at 6 weeks and 3 months after the intervention, the rehabilitation motivation scores in the experimental group were respectively 3.10 and 2.54 points higher than those in the control group, with significant differences.
CONCLUSIONS


MI could effectively enhance motivation for rehabilitation among stroke patients.",2020,The BI and IADLs scores significantly improved with time in both the experimental and control groups.,"['Stroke Patients', 'first-stroke patients', '65 patients between March and October 2016', 'stroke patients']","['Motivational Interviewing', 'individual attention from a research nurse weekly for 6 weeks', 'routine care', 'motivational interviewing (MI']","['demographic data, activities of daily living data (Barthel index {BI} and instrumental activities of daily living {IADLs} scale), and rehabilitation motivation data', 'BI and IADLs scores', 'rehabilitation motivation scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",65.0,0.0288482,The BI and IADLs scores significantly improved with time in both the experimental and control groups.,"[{'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Hsiao-Lu', 'Initials': 'HL', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Yuhing Junior College of Health Care & Management, Kaohsiung 80776, Taiwan.'}, {'ForeName': 'Fu-Chi', 'Initials': 'FC', 'LastName': 'Yang', 'Affiliation': 'College of General Education, National Chin-Yi University of Technology, Taichung 40201, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Chao', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung 43302, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17082755']
228,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


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


Prospective crossover physiologic study.
SETTING


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


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


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


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


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
229,32096706,Noninvasive Diagnosis of Nonalcoholic Fatty Liver Disease and Quantification of Liver Fat with Radiofrequency Ultrasound Data Using One-dimensional Convolutional Neural Networks.,"Background Radiofrequency ultrasound data from the liver contain rich information about liver microstructure and composition. Deep learning might exploit such information to assess nonalcoholic fatty liver disease (NAFLD). Purpose To develop and evaluate deep learning algorithms that use radiofrequency data for NAFLD assessment, with MRI-derived proton density fat fraction (PDFF) as the reference. Materials and Methods A HIPAA-compliant secondary analysis of a single-center prospective study was performed for adult participants with NAFLD and control participants without liver disease. Participants in the parent study were recruited between February 2012 and March 2014 and underwent same-day US and MRI of the liver. Participants were randomly divided into an equal number of training and test groups. The training group was used to develop two algorithms via cross-validation: a classifier to diagnose NAFLD (MRI PDFF ≥ 5%) and a fat fraction estimator to predict MRI PDFF. Both algorithms used one-dimensional convolutional neural networks. The test group was used to evaluate the classifier for sensitivity, specificity, positive predictive value, negative predictive value, and accuracy and to evaluate the estimator for correlation, bias, limits of agreements, and linearity between predicted fat fraction and MRI PDFF. Results A total of 204 participants were analyzed, 140 had NAFLD (mean age, 52 years ± 14 [standard deviation]; 82 women) and 64 were control participants (mean age, 46 years ± 21; 42 women). In the test group, the classifier provided 96% (95% confidence interval [CI]: 90%, 99%) (98 of 102) accuracy for NAFLD diagnosis (sensitivity, 97% [95% CI: 90%, 100%], 68 of 70; specificity, 94% [95% CI: 79%, 99%], 30 of 32; positive predictive value, 97% [95% CI: 90%, 99%], 68 of 70; negative predictive value, 94% [95% CI: 79%, 98%], 30 of 32). The estimator-predicted fat fraction correlated with MRI PDFF (Pearson  r  = 0.85). The mean bias was 0.8% ( P  = .08), and 95% limits of agreement were -7.6% to 9.1%. The predicted fat fraction was linear with an MRI PDFF of 18% or less ( r  = 0.89, slope = 1.1, intercept = 1.3) and nonlinear with an MRI PDFF greater than 18%. Conclusion Deep learning algorithms using radiofrequency ultrasound data are accurate for diagnosis of nonalcoholic fatty liver disease and hepatic fat fraction quantification when other causes of steatosis are excluded. © RSNA, 2020  Online supplemental material is available for this article.  See also the editorial by Lockhart and Smith in this issue.",2020,Conclusion Deep learning algorithms using radiofrequency ultrasound data are accurate for diagnosis of nonalcoholic fatty liver disease and hepatic fat fraction quantification when other causes of steatosis are excluded.,"['adult participants with NAFLD and control participants without liver disease', 'Participants in the parent study were recruited between February 2012 and March 2014 and underwent same-day US and MRI of the liver', 'A total of 204 participants were analyzed, 140 had NAFLD (mean age, 52 years ± 14 [standard deviation]; 82 women) and 64 were control participants (mean age, 46 years ± 21; 42 women']","['Radiofrequency Ultrasound Data', 'MRI-derived proton density fat fraction (PDFF']",['mean bias'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",204.0,0.0877033,Conclusion Deep learning algorithms using radiofrequency ultrasound data are accurate for diagnosis of nonalcoholic fatty liver disease and hepatic fat fraction quantification when other causes of steatosis are excluded.,"[{'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Byra', 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}, {'ForeName': 'Elhamy', 'Initials': 'E', 'LastName': 'Heba', 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Andre', 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Erdman', 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}, {'ForeName': 'Claude B', 'Initials': 'CB', 'LastName': 'Sirlin', 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': ""O'Brien"", 'Affiliation': 'From the Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (A.H., W.D.O.), and Department of Food Science and Human Nutrition (J.W.E.), University of Illinois at Urbana-Champaign, 306 N Wright St, Urbana, IL 61801; Department of Radiology (M.B., M.P.A.), Liver Imaging Group, Department of Radiology (E.H., C.B.S.), and NAFLD Research Center, Division of Gastroenterology, Department of Medicine (R.L.), University of California, San Diego, La Jolla, Calif; and Department of Ultrasound, Institute of Fundamental Technological Research, Polish Academy of Sciences, Warsaw, Poland (M.B.).'}]",Radiology,['10.1148/radiol.2020191160']
230,30821829,Assessment of Vascular Event Prevention and Cognitive Function Among Older Adults With Preexisting Vascular Disease or Diabetes: A Secondary Analysis of 3 Randomized Clinical Trials.,"Importance


Acquisition of reliable randomized clinical trial evidence of the effects of cardiovascular interventions on cognitive decline is a priority.
Objectives


To estimate the association of cognitive aging with the avoidance of vascular events in cardiovascular intervention trials and understand whether reports of nonsignificant results exclude worthwhile benefit.
Design, Setting, and Participants


This secondary analysis of 3 randomized clinical trials in participants with preexisting occlusive vascular disease or diabetes included survivors to final in-trial follow-up in the Heart Protection Study (HPS), Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), and Treatment of HDL (High-Density Lipoprotein) to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trials of lipid modification for prevention of cardiovascular events. Data were collected from February 1994 through January 2013 and analyzed from January 2015 through December 2018.
Exposures


Incident vascular events and diabetes and statin therapy.
Main Outcomes and Measures


Cognitive function was assessed at the end of a mean (SD) of 4.9 (1.5) years of follow-up using a 14-item verbal test. Associations of the incidence of vascular events and new-onset diabetes during the trials, with cognitive function at final in-trial follow-up were estimated and expressed as years of cognitive aging (using the association of the score with age >60 years). The benefit on cognitive aging mediated through the effects of lowering low-density lipoprotein cholesterol levels on events was estimated by applying these findings to nonfatal event differences observed with statin therapy in the HPS trial.
Results


Among 45 029 participants undergoing cognitive assessment, mean (SD) age was 67.9 (8.0) years; 80.7% were men. Incident stroke (n = 1197) was associated with 7.1 (95% CI, 5.7-8.5) years of cognitive aging; incident transient ischemic attack, myocardial infarction, heart failure, and new-onset diabetes were associated with 1 to 2 years of cognitive aging. In HPS, randomization to statin therapy for 5 years resulted in 2.0% of survivors avoiding a nonfatal stroke or transient ischemic attack and 2.4% avoiding a nonfatal cardiac event, which yielded an expected reduction in cognitive aging of 0.15 (95% CI, 0.11-0.19) years. With 15 926 participants undergoing cognitive assessment, HPS had 80% power to detect a 1-year (ie, 20% during the 5 years) difference in cognitive aging.
Conclusions and Relevance


The expected cognitive benefits of the effects of preventive therapies on cardiovascular events during even the largest randomized clinical trials may have been too small to be detectable. Hence, nonsignificant findings may not provide good evidence of a lack of worthwhile benefit on cognitive function with prolonged use of such therapies.
Trial Registration


isrctn.com and ClinicalTrials.gov Identifiers: ISRCTN48489393, ISRCTN74348595, and NCT00461630.",2019,"Incident stroke (n = 1197) was associated with 7.1 (95% CI, 5.7-8.5) years of cognitive aging; incident transient ischemic attack, myocardial infarction, heart failure, and new-onset diabetes were associated with 1 to 2 years of cognitive aging.","['45 029 participants undergoing cognitive assessment, mean (SD) age was 67.9 (8.0) years; 80.7% were men', 'participants with preexisting occlusive vascular disease or diabetes included survivors to final in-trial follow-up in the Heart Protection Study (HPS', 'Older Adults With Preexisting Vascular Disease or Diabetes', 'Data were collected from February 1994 through January 2013 and analyzed from January 2015 through December 2018']",['cardiovascular interventions'],"['cardiovascular events', 'Vascular Event Prevention and Cognitive Function', 'vascular events and new-onset diabetes', 'Cholesterol and Homocysteine (SEARCH', 'nonfatal stroke or transient ischemic attack', 'nonfatal cardiac event', 'Measures\n\n\nCognitive function', 'cognitive aging; incident transient ischemic attack, myocardial infarction, heart failure, and new-onset diabetes', 'cognitive aging']","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4042952', 'cui_str': 'Cognitive Aging'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",45029.0,0.284966,"Incident stroke (n = 1197) was associated with 7.1 (95% CI, 5.7-8.5) years of cognitive aging; incident transient ischemic attack, myocardial infarction, heart failure, and new-onset diabetes were associated with 1 to 2 years of cognitive aging.","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Offer', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Arnold', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Clarke', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Bennett', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bowman', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, Beijing, China.'}, {'ForeName': 'Jemma C', 'Initials': 'JC', 'LastName': 'Hopewell', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Landray', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parish', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2019.0223']
231,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND


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


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


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


Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
232,32309876,"The Feasibility, Safety, and Efficacy of the Preemptive Indwelling of Double-J Stents in Percutaneous Nephrolithotomy Surgery: A Randomized Controlled Trial.","PURPOSE


The goal of this study is to compare the feasibility, safety, and efficacy of the preemptive indwelling of double-J stents (PI-DJS) versus the conventional preemptive indwelling of ureteral catheters (PI-UC) in percutaneous nephrolithotomy (PCNL) via a randomized, controlled clinical study.
MATERIALS AND METHODS


A total of 75 patients with complex renal calculi underwent PCNL surgery and were randomized, using random number table, to receive either a PI-DJS (37 cases) or a PI-UC (38 cases). All operations were performed by the same experienced surgeon. Several outcomes were measured, including duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications.
RESULTS


Guided by B-ultrasound, percutaneous passages were successfully established in all patients who then underwent one-stage PCNL. The time required to establish a passage using a PI-DJS was 7.5min, whereas that of the group who received a PI-UC was 11.5min (P < 0.01). There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (all P > 0.05).
CONCLUSION


PI-DJS during PCNL allowed for a reliable and stable reflux from the bladder into the renal pelvis to produce an artificial hydronephrosis without the formation of microbubbles, unlike conventional ureteral catheters.",2020,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","['Percutaneous Nephrolithotomy Surgery', '75 patients with complex renal calculi underwent PCNL surgery']","['Preemptive Indwelling of Double-J Stents', 'conventional preemptive indwelling of ureteral catheters (PI-UC', 'PI-DJS', 'preemptive indwelling of double-J stents (PI-DJS', 'percutaneous nephrolithotomy (PCNL']","['feasibility, safety, and efficacy', 'duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications', 'Feasibility, Safety, and Efficacy', 'operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences']","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",75.0,0.0259171,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","[{'ForeName': 'Fuding', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. bfd0816@hotmail.com.'}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'JiMin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}]",Urology journal,['10.22037/uj.v0i0.4957']
233,32311072,Pharmacological treatment for familial amyloid polyneuropathy.,"BACKGROUND


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


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


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


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


We followed standard Cochrane methodology.
MAIN RESULTS


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


Evidence on the pharmacological treatment of FAPs from RCTs is limited to TTR-FAP. No studies directly compare disease-modifying pharmacological treatments for TTR-FAP. Results from placebo-controlled trials indicate that tafamidis, diflunisal, patisiran, and inotersen may be beneficial in TTR-FAP, but further investigations are needed. Since direct comparative studies for TTR-FAP will be hampered by sample size and costs required to demonstrate superiority of one drug over another, long-term non-randomised open-label studies monitoring their efficacy and safety are needed.",2020,"Inotersen may slightly increase mortality (RR 5.94, 95% CI 0.33 to 105.60; P = 0.22; low-certainty evidence) and occurrence of severe adverse events (RR 1.48, 95% CI 0.85 to 2.57; P = 0.16; low-certainty evidence) compared to placebo.","['655 people with TTR-FAP', 'familial amyloid polyneuropathy', 'familial amyloid polyneuropathies (FAPs', 'adults with FAPs']","['placebo', 'diflunisal with placebo', 'quasi-RCTs', 'diflunisal']","['adverse events', 'efficacy, acceptability, and tolerability', 'peripheral neuropathy', 'severity of peripheral neuropathy, change in modified body mass index (mBMI), quality of life, severity of depression, mortality, and adverse events', 'apolipoprotein AI-FAP, gelsolin-FAP, and beta-2-microglobulin-FAP', 'number of participants who died', 'severe adverse event', 'progression of disability', 'number of people who died', 'progression of peripheral neuropathy', 'mortality', 'progression of disability (Rasch-built Overall Disability Scale', 'occurrence of severe adverse events', 'quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0206245', 'cui_str': 'Familial amyloid polyneuropathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012228', 'cui_str': 'Diflunisal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0206245', 'cui_str': 'Familial amyloid polyneuropathy'}, {'cui': 'C0061187', 'cui_str': 'Gelsolin'}, {'cui': 'C0005149', 'cui_str': 'Beta 2 microglobulin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",655.0,0.543706,"Inotersen may slightly increase mortality (RR 5.94, 95% CI 0.33 to 105.60; P = 0.22; low-certainty evidence) and occurrence of severe adverse events (RR 1.48, 95% CI 0.85 to 2.57; P = 0.16; low-certainty evidence) compared to placebo.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Magrinelli', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Fabrizi', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Santoro', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive Sciences and Odontostomatology, Via Sergio Pansini n. 5, Naples, Italy, 80131.'}, {'ForeName': 'Fiore', 'Initials': 'F', 'LastName': 'Manganelli', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive Sciences and Odontostomatology, Via Sergio Pansini n. 5, Naples, Italy, 80131.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Zanette', 'Affiliation': 'Pederzoli Hospital, Neurology Section, Via Monte Baldo n° 24, Peschiera del Garda, VR, Italy, 37019.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Cavallaro', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012395.pub2']
234,30911782,Use of antiosteoporotic medication in the Danish ROSE population-based screening study.,"Use of antiosteoporotic medication in the population-based, risk-stratified osteoporosis strategy evaluation (ROSE) screening study, comparing the use of FRAX followed by DXA with usual care, was examined. Screening increased the overall use of medication. Being recommended treatment by the hospital and higher age increased the likelihood of starting medication, but, nevertheless, a large percentage opted not to start treatment.
INTRODUCTION


The aim of the study was to examine the impact on medication prescription, adherence, and persistence of osteoporotic medicine in the randomized population-based ROSE screening study for osteoporosis.
METHODS


The Danish ROSE study included a population-based random sample of women aged 65-81 years randomized to either a two-step screening program consisting of FRAX followed by DXA for high-risk participants or opportunistic screening for osteoporosis (usual care). This sub-study on the intention-to-treat population examined the impact of the screening program on antiosteoporotic medication redemption rates, adherence, and persistence using Danish registers.
RESULTS


A total of 30,719 of 34,229 women were treatment-naïve. Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found. Higher age was associated with a higher likelihood of starting medication. A low Charlson comorbidity score (= 1) was associated with higher treatment initiation but lower adherence and persistence of antiosteoporotic treatment. A total of 31.7% of participants advised to initiate treatment did not follow the advice.
CONCLUSIONS


Screening for osteoporosis using FRAX followed by DXA increased the overall use of antiosteoporotic medication in the screening group without differences in adherence and persistence rates. A large percentage of participants advised to initiate treatment did nevertheless fail to do so.",2019,"Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found.","['Danish ROSE study included a population-based random sample of women aged 65-81\xa0years', 'A total of 30,719 of 34,229 women were treatment-naïve']","['antiosteoporotic medication', 'FRAX followed by DXA for high-risk participants or opportunistic screening for osteoporosis (usual care', 'FRAX']","['antiosteoporotic medication', 'adherence and persistence rates', 'overall use of medication']","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0422389', 'cui_str': 'Opportunistic screening (procedure)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",34229.0,0.0382527,"Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Høiberg', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark. mikkelhoiberg@gmail.com.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Rubin', 'Affiliation': 'OPEN - Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holmberg', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Rothmann', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'OPEN - Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gram', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bech', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brixen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Hermann', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-04934-7']
235,31049735,Addressing the pitfalls when designing intervention studies to discover and validate biomarkers of habitual dietary intake.,"INTRODUCTION


Dietary exposure monitoring within populations is reliant on self-reported measures such as Food Frequency Questionnaires and diet diaries. These methods often contain inaccurate information due to participant misreporting, non-compliance and bias. Urinary metabolites derived from individual foods could provide additional objective indicators of dietary exposure. For biomarker approaches to have utility it is essential that they cover a wide-range of commonly consumed foods and the methodology works in a real-world environment.
OBJECTIVES


To test that the methodology works in a real-world environment and to consider the impact of the major sources of likely variance; particularly complex meals, different food formulations, processing and cooking methods, as well as the dynamics of biomarker duration in the body.
METHODS


We designed and tested a dietary exposure biomarker discovery and validation strategy based on a food intervention study involving free-living individuals preparing meals and collecting urine samples at home. Two experimental periods were built around three consecutive day menu plans where all foods and drinks were provided (n = 15 and n = 36).
RESULTS


The experimental design was validated by confirming known consumption biomarkers in urinary samples after the first menu plan. We tested biomarker performance with different food formulations and processing methods involving meat, wholegrain, fruits and vegetables.
CONCLUSION


It was demonstrated that spot urine samples, together with robust dietary biomarkers, despite major sources of variance, could be used successfully for dietary exposure monitoring in large epidemiological studies.",2019,"It was demonstrated that spot urine samples, together with robust dietary biomarkers, despite major sources of variance, could be used successfully for dietary exposure monitoring in large epidemiological studies.",['free-living individuals preparing meals and collecting urine samples at home'],"['meat, wholegrain, fruits and vegetables']",[],"[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1290962', 'cui_str': 'Preparing meals'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",[],,0.03393,"It was demonstrated that spot urine samples, together with robust dietary biomarkers, despite major sources of variance, could be used successfully for dietary exposure monitoring in large epidemiological studies.","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Lloyd', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, SY23 3DA, UK.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, NE2 4HH, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wilson', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, SY23 3DA, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zubair', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, SY23 3DA, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chambers', 'Affiliation': 'Nutrition and Dietetic Research Group, Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Hammersmith Hospital Campus, Imperial College London, London, W12 0NN, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Garcia-Perez', 'Affiliation': 'Nutrition and Dietetic Research Group, Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Hammersmith Hospital Campus, Imperial College London, London, W12 0NN, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, NE2 4HH, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tailliart', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, SY23 3DA, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, SY23 3DA, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, NE2 4HH, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Draper', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, SY23 3DA, UK. jhd@aber.ac.uk.'}]",Metabolomics : Official journal of the Metabolomic Society,['10.1007/s11306-019-1532-3']
236,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


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


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


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


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
237,32310260,"Investigation of ward fidelity to a multicomponent delirium prevention intervention during a multicentre, pragmatic, cluster randomised, controlled feasibility trial.","BACKGROUND


delirium is a frequent complication of hospital admission for older people and can be reduced by multicomponent interventions, but implementation and delivery of such interventions is challenging.
OBJECTIVE


to investigate fidelity to the prevention of delirium system of care within a multicentre, pragmatic, cluster randomised, controlled feasibility trial.
SETTING


five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales.
DATA COLLECTION


research nurse observations of ward practice; case note reviews and examination of documentation.
ASSESSMENT


10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1).
RESULTS


the mean score (range) for each domain was: installation 4.5 (3.5-5); delivery 32.6 (range 27.3-38.3); coverage 7.9 (range 4.2-10.1); and duration 0.38 (0-1). Of the 10 delirium risk factors, infection, nutrition, hypoxia and pain were the most and cognitive impairment, sensory impairment and multiple medications the least consistently addressed. Overall fidelity to the intervention was assessed as high (≥80%) in two wards, medium (51-79%) in five wards and low (≤50%) in one ward.
CONCLUSION


the trial was designed as a pragmatic evaluation, and the findings of medium intervention fidelity are likely to be generalisable to delirium prevention in routine care and provide an important context to interpret the trial outcomes.",2020,"10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1).
","[""10 health care professionals with experience in older people's"", 'five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales']",['multicomponent delirium prevention intervention'],"['Overall fidelity', '10 delirium risk factors, infection, nutrition, hypoxia and pain']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.116063,"10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1).
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Siddiqi', 'Affiliation': 'Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}]",Age and ageing,['10.1093/ageing/afaa042']
238,32187789,Does Pain Neuroscience Education and Cognition-Targeted Motor Control Training Improve Cervical Motor Output? Secondary Analysis of a Randomized Clinical Trial.,"BACKGROUND


In the context of interventions aimed at reducing pain, disability, and maladaptive pain cognitions in chronic neck pain, it is hypothesized that patients who have greater symptom reduction possibly also demonstrate greater improvement in cervical motor output. Therefore, the aim of this study was to examine the effect of pain neuroscience education plus cognition-targeted motor control training on cervical motor output.
METHODS


Impairments in cervical motor output were measured in 64 subjects with chronic neck pain using standardized tests. Cervical muscle strength, cervical mobility, balance, and cervical neuromuscular control were derived. To assess the differences between groups in response to treatment, a random-intercept linear mixed-models analysis, applying a diagonal covariance matrix, was used.
RESULTS


A significant treatment × time interaction effect was found for neuromuscular control of the deep cervical flexors, favoring the experimental treatment at 3 months' follow-up (mean group difference: 1.982; 95% confidence interval 0.779, 3.185; large effect size d = 0.82). Significant main effects of time were found for the neuromuscular capacity of scapulothoracic muscles and for cervical mobility. No significant effects were found for balance, cervical muscle strength, or endurance of cervical flexors.
CONCLUSION


Pain neuroscience education combined with cognition-targeted motor control training is not more effective than biomedically focused education and exercise therapy for improving cervical motor output in people with chronic neck pain. Our findings question the relative importance of factors such as pain, disability, and maladaptive pain cognitions on cervical motor output and the need to address it in treatment.",2020,"A significant treatment x time interaction effect was found for neuromuscular control of the deep cervical flexors, favoring the experimental treatment at 3 months follow-up (mean group difference: 1.982; 95% CI 0.779,3.185; large effect size D =.82).","['people with chronic neck pain', '64 subjects with chronic neck pain using standardized tests']","['cognition-targeted motor control training', 'exercise therapy', 'pain neuroscience education plus cognition-targeted motor control training']","['balance, cervical muscle strength and endurance of cervical flexors', 'neuromuscular control of the deep cervical flexors', 'neuromuscular capacity of scapulothoracic muscles and for cervical mobility', 'Cervical muscle strength, cervical mobility, balance and cervical neuromuscular control']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",64.0,0.175545,"A significant treatment x time interaction effect was found for neuromuscular control of the deep cervical flexors, favoring the experimental treatment at 3 months follow-up (mean group difference: 1.982; 95% CI 0.779,3.185; large effect size D =.82).","[{'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Willaert', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Anneleen', 'Initials': 'A', 'LastName': 'Malfliet', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Coppieters', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Dorine', 'Initials': 'D', 'LastName': 'Lenoir', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Robby', 'Initials': 'R', 'LastName': 'De Pauw', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Danneels', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Roussel', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy (MOVANT), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Meeus', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cagnie', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kregel', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12884']
239,30772848,"PROFIT, a PROspective, randomised placebo controlled feasibility trial of Faecal mIcrobiota Transplantation in cirrhosis: study protocol for a single-blinded trial.","INTRODUCTION


Patients with advanced cirrhosis have enteric bacterial dysbiosis and translocation of bacteria and their products across the gut epithelial barrier. This culminates in systemic inflammation and endotoxaemia, inducing innate immune dysfunction which predisposes to infection, and development of complications such as bleeding, sepsis and hepatic encephalopathy. This feasibility study aims to assess the safety of administering faecal microbiota transplantion to patients with cirrhosis and explore the effect of the intervention on their prognosis by achieving restoration of a healthy gut microbiome.
METHODS AND ANALYSIS


A PROspective, randomised placebo controlled feasibility trial of Faecal mIcrobiota Transplantation is a single-centre, randomised, single-blinded, placebo-controlled study evaluating faecal microbiota transplantation (FMT) against placebo. Patients with advanced but stable cirrhosis with a Model for End-Stage Liver Disease score between 10 and 16 will be recruited. Twenty-four patients will be randomised to FMT plus standard of care (as per our institutional practice) and eight patients to placebo in a ratio of 3:1. Patients will be evaluated at baseline before the study intervention is administered and at 7, 30 and 90 days post-intervention to assess safety and adverse events. FMT/placebo will be administered into the jejunum within 7 days of baseline. The primary outcome measure will be safety and feasibility as assessed by recruitment rates, tolerability and safety of FMT treatment. Results will be disseminated via peer-reviewed journals and international conferences. The recruitment of the first patient occurred on 23 May 2018.
ETHICS AND DISSEMINATION


Research Ethics approval was given by the London South East Research Ethics committee (ref 17/LO/2081).
TRIAL REGISTRATION NUMBER


NCT02862249 and EudraCT 2017-003629-13.",2019,"INTRODUCTION


Patients with advanced cirrhosis have enteric bacterial dysbiosis and translocation of bacteria and their products across the gut epithelial barrier.","['Patients with advanced cirrhosis', 'Patients with advanced but stable cirrhosis with a Model for End-Stage Liver Disease score between 10 and 16 will be recruited', 'cirrhosis', 'patients with cirrhosis']","['FMT plus standard of care', 'faecal microbiota transplantion', 'placebo', 'FMT/placebo', 'Faecal mIcrobiota Transplantation', 'faecal microbiota transplantation (FMT) against placebo']","['safety and feasibility as assessed by recruitment rates, tolerability and safety of FMT treatment', 'safety and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1263666', 'cui_str': 'Advanced cirrhosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.61951,"INTRODUCTION


Patients with advanced cirrhosis have enteric bacterial dysbiosis and translocation of bacteria and their products across the gut epithelial barrier.","[{'ForeName': 'Charlotte Alexandra', 'Initials': 'CA', 'LastName': 'Woodhouse', 'Affiliation': ""James Black Centre, School of Immunology & Microbial Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Vishal C', 'Initials': 'VC', 'LastName': 'Patel', 'Affiliation': ""James Black Centre, School of Immunology & Microbial Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Goldenberg', 'Affiliation': ""Department of Microbiology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sanchez-Fueyo', 'Affiliation': ""James Black Centre, School of Immunology & Microbial Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'China', 'Affiliation': 'Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': ""O'Brien"", 'Affiliation': 'Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Flach', 'Affiliation': ""School of Population Health & Environmental Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Douiri', 'Affiliation': ""School of Population Health & Environmental Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Shawcross', 'Affiliation': ""James Black Centre, School of Immunology & Microbial Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2018-023518']
240,30957341,"Feasibility, acceptability and cost-effectiveness of a brief, lay counsellor-delivered psychological treatment for men with alcohol dependence in primary care: an exploratory randomized controlled trial.","AIMS


To examine the feasibility, acceptability and preliminary cost-effectiveness of a lay counsellor delivered psychological treatment for men with alcohol dependence in primary care.
DESIGN


Single-blind individually randomized trial comparing counselling for alcohol problems (CAP) plus enhanced usual care (EUC) versus EUC only.
SETTING


Ten primary health centres in Goa, India.
PARTICIPANTS


Men (n = 135) scoring ≥ 20 on the Alcohol Use Disorder Identification Test (AUDIT). Sixty-six participants were randomized to EUC and 69 to CAP + EUC.
INTERVENTIONS


CAP, a lay counsellor-delivered psychological treatment for harmful drinking, with referral to de-addiction centre for medically assisted detoxification. EUC comprised consultation with physician, providing screening results and referral to a de-addiction centre.
MEASUREMENTS


Baseline socio-demographic data, readiness to change and perceived usefulness of counselling. Acceptability and feasibility process indicators such as data on screening and therapy. Outcomes were measured at 3 and 12 months post-randomization and included remission, mean daily alcohol consumed, percentage of days abstinent (PDA), percentage of days of heavy drinking (PDHD), recovery, uptake of detoxification services, impacts of alcohol dependence, resource use and costs.
FINDINGS


Participants in the CAP + EUC arm had more numerically but not statistically significantly favourable outcomes compared with those in the EUC arm for (a) remission at 3 months [adjusted odds ratio (aOR) = 1.95, 95% confidence interval (CI) = 0.74-5.15] and 12 months (aOR = 1.90, 95% CI = 0.72-5.00), (b) proportion of non-drinkers at 3 months (aOR = 1.26; 95% CI = 0.58-2.75) and 12 months (aOR = 1.25; 95% CI = 0.58-2.64) and (c) ethanol consumption among drinkers at 3 months (count ratio = 0.91; 95% CI = 0.58-1.45) and 12 months (count ratio = 1.06; 95% CI = 0.73-1.54). There was no statistically significant evidence of a difference in the occurrence of serious adverse events between the two arms. From a societal perspective, there was a 53% chance of CAP + EUC being cost-effective in achieving remission at 12 months at the willingness-to-pay threshold of $415.
CONCLUSIONS


Lay counsellor-delivered psychological treatment for men with alcohol dependence (AD) in primary care may be effective in managing AD in low- and middle-income countries. A definitive trial of the intervention is warranted.",2019,"FINDINGS


Participants in the CAP + EUC arm had more numerically but not statistically significantly favourable outcomes compared with those in the EUC arm for (a) remission at 3 months [adjusted odds ratio (aOR) = 1.95, 95% confidence interval (CI) = 0.74-5.15] and 12 months (aOR = 1.90, 95% CI = 0.72-5.00), (b) proportion of non-drinkers at 3 months (aOR = 1.26; 95% CI = 0.58-2.75) and 12 months (aOR = 1.25; 95% CI = 0.58-2.64) and (c) ethanol consumption among drinkers at 3 months (count ratio = 0.91; 95% CI = 0.58-1.45) and 12 months (count ratio = 1.06; 95% CI = 0.73-1.54).","['men with alcohol dependence (AD', 'Men (n\xa0', 'men with alcohol dependence in primary care', 'Ten primary health centres in Goa, India', 'Sixty-six participants']","['lay counsellor-delivered psychological treatment', 'EUC', 'lay counsellor delivered psychological treatment', 'counselling for alcohol problems (CAP) plus enhanced usual care (EUC) versus EUC only', 'CAP, a lay counsellor-delivered psychological treatment for harmful drinking, with referral to de-addiction centre for medically assisted detoxification', 'CAP\xa0+\xa0EUC']","['included remission, mean daily alcohol consumed, percentage of days abstinent (PDA), percentage of days of heavy drinking (PDHD), recovery, uptake of detoxification services, impacts of alcohol dependence, resource use and costs', 'feasibility, acceptability and preliminary cost-effectiveness', 'Baseline socio-demographic data, readiness to change and perceived usefulness of counselling', 'occurrence of serious adverse events', 'Feasibility, acceptability and cost-effectiveness']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",66.0,0.149614,"FINDINGS


Participants in the CAP + EUC arm had more numerically but not statistically significantly favourable outcomes compared with those in the EUC arm for (a) remission at 3 months [adjusted odds ratio (aOR) = 1.95, 95% confidence interval (CI) = 0.74-5.15] and 12 months (aOR = 1.90, 95% CI = 0.72-5.00), (b) proportion of non-drinkers at 3 months (aOR = 1.26; 95% CI = 0.58-2.75) and 12 months (aOR = 1.25; 95% CI = 0.58-2.64) and (c) ethanol consumption among drinkers at 3 months (count ratio = 0.91; 95% CI = 0.58-1.45) and 12 months (count ratio = 1.06; 95% CI = 0.73-1.54).","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Nadkarni', 'Affiliation': 'Sangath, Socorro, Goa, India.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Velleman', 'Affiliation': 'Sangath, Socorro, Goa, India.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDaid', 'Affiliation': 'Personal Social Services Research Unit, Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'A-La', 'Initials': 'AL', 'LastName': 'Park', 'Affiliation': 'Personal Social Services Research Unit, Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Weobong', 'Affiliation': 'Sangath, Socorro, Goa, India.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Bhat', 'Affiliation': 'Sangath, Socorro, Goa, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath, Socorro, Goa, India.'}]","Addiction (Abingdon, England)",['10.1111/add.14630']
241,30582281,Comparison of the effects of standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB on the histology and function of renal allografts.,"Targeting the renin-angiotensin system and optimizing tacrolimus exposure are both postulated to improve outcomes in renal transplant recipients (RTRs) by preventing interstitial fibrosis/tubular atrophy (IF/TA). In this multicenter, prospective, open-label controlled trial, adult de novo RTRs were randomized in a 2 × 2 design to low- vs standard-dose (LOW vs STD) prolonged-release tacrolimus and to angiotensin-converting enzyme inhibitors/angiotensin II receptor 1 blockers (ACEi/ARBs) vs other antihypertensive therapy (OAHT). There were 2 coprimary endpoints: the prevalence of IF/TA at month 6 and at month 24. IF/TA prevalence was similar for LOW vs STD tacrolimus at month 6 (36.8% vs 39.5%; P = .80) and ACEi/ARBs vs OAHT at month 24 (54.8% vs 58.2%; P = .33). IF/TA progression decreased significantly with LOW vs STD tacrolimus at month 24 (mean [SD] change, +0.42 [1.477] vs +1.10 [1.577]; P = .0039). Across the 4 treatment groups, LOW + ACEi/ARB patients exhibited the lowest mean IF/TA change and, compared with LOW + OAHT patients, experienced significantly delayed time to first T cell-mediated rejection. Renal function was stable from month 1 to month 24 in all treatment groups. No unexpected safety findings were detected. Coupled with LOW tacrolimus dosing, ACEi/ARBs appear to reduce IF/TA progression and delay rejection relative to reduced tacrolimus exposure without renin-angiotensin system blockade. ClinicalTrials.gov identifier: NCT00933231.",2019,Renal function was stable from month 1 to month 24 in all treatment groups.,['adult de novo RTRs'],"['LOW vs STD tacrolimus', 'low- vs standard-dose (LOW vs STD) prolonged-release tacrolimus and to angiotensin-converting enzyme inhibitors/angiotensin II receptor 1 blockers (ACEi/ARBs) vs other antihypertensive therapy (OAHT', 'standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB']","['Renal function', 'prevalence of IF/TA', 'delayed time to first T cell-mediated rejection', 'TA progression', 'IF/TA prevalence', 'histology and function of renal allografts']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0003011', 'cui_str': 'Receptor, Angiotensin II'}, {'cui': 'C3539170', 'cui_str': 'OTHER ANTIHYPERTENSIVES in ATC'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0522486', 'cui_str': 'Delay time (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}]",,0.018907,Renal function was stable from month 1 to month 24 in all treatment groups.,"[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Cockfield', 'Affiliation': 'University of Alberta Hospital, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, Illinois.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Campbell', 'Affiliation': 'University of Alberta Hospital, Edmonton, Alberta, Canada.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cantarovich', 'Affiliation': 'McGill University Health Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Gangji', 'Affiliation': ""St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Houde', 'Affiliation': ""L'Hôtel-Dieu de Quebec, Quebec City, Québec, Canada.""}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Jevnikar', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Tammy M', 'Initials': 'TM', 'LastName': 'Keough-Ryan', 'Affiliation': 'Queen Elizabeth II, HSC, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Felix-Mauricio', 'Initials': 'FM', 'LastName': 'Monroy-Cuadros', 'Affiliation': 'Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Nickerson', 'Affiliation': 'Health Sciences Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Michel R', 'Initials': 'MR', 'LastName': 'Pâquet', 'Affiliation': 'Hôpital Notre-Dame du CHUM, Montreal, Québec, Canada.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Ramesh Prasad', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Senécal', 'Affiliation': 'Hôpital Maisonneuve-Rosemont, Montreal, Québec, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shoker', 'Affiliation': ""St. Paul's Hospital, Saskatoon, Saskatchewan, Canada.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'Centre Hospitalier Universitaire, Sherbrooke, Québec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Howell', 'Affiliation': 'Astellas Pharma Global Development, Inc., Markham, Ontario, Canada.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Schwartz', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, Illinois.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Rush', 'Affiliation': 'Health Sciences Centre, Winnipeg, Manitoba, Canada.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15225']
242,30944136,'Off pump' self-expanding injectable tissue valves (IPVR) versus 'on pump' conventional tissue valves (PVR) for replacement of the pulmonary valve: trial protocol for a randomised controlled trial (InVITe trial).,"INTRODUCTION


Patients with congenital heart disease often need repeated operations throughout life to replace the pulmonary valve. Valve replacement with 'injectable' self-expanding valves (which is performed 'off pump' without the use of cardiopulmonary bypass, CPB) may result in quicker recovery and lower risk of major complications than valve replacement with conventional valves (which is performed 'on pump' with the use of CPB).
METHODS AND ANALYSIS


We are conducting a multicentre, single-blind randomised controlled trial in patients with congenital heart disease and aged between 12 and 80 years. We will randomise participants in a 1:1 ratio to receive either 'off pump' injectable pulmonary valve replacement or 'on pump' conventional pulmonary valve replacement. The primary outcome will be the difference between the groups with respect to post-surgery blood loss (as measured by chest drain volume) in the first 24 hours. Secondary outcomes will include in-hospital outcomes (intensive care unit stay, inotropic/vasodilator support, chest drain volume in the first 12 hours post-surgery, time of readiness for extubation, blood products used in the first 24 hours post-surgery, time of fitness for discharge, valve and heart function 6 months post-surgery (assessed using cardiovascular magnetic resonance and ECHOCARDIOGRAPHY) and health-related quality of life 6 weeks and 6 months post-surgery.
ETHICS AND DISSEMINATION


This trial has been approved by the South West Exeter Research Ethics Committee. Findings will be shared with participating hospitals and disseminated to the academic community through peer reviewed publications and presentation at national and international meetings. Patients will be informed of the results through patient organisations and newsletters to participants.
TRIAL REGISTRATION NUMBER


ISRCTN23538073.",2019,"Valve replacement with 'injectable' self-expanding valves (which is performed 'off pump' without the use of cardiopulmonary bypass, CPB) may result in quicker recovery and lower risk of major complications than valve replacement with conventional valves (which is performed 'on pump' with the use of CPB).
","['patients with congenital heart disease and aged between 12 and 80 years', 'Patients with congenital heart disease often need repeated operations throughout life to replace the pulmonary valve']","[""Valve replacement with 'injectable' self-expanding valves"", ""pump' self-expanding injectable tissue valves (IPVR) versus 'on pump' conventional tissue valves (PVR"", ""pump' injectable pulmonary valve replacement or 'on pump' conventional pulmonary valve replacement""]","['post-surgery blood loss', 'hospital outcomes (intensive care unit stay, inotropic/vasodilator support, chest drain volume in the first 12\u2009hours post-surgery, time of readiness for extubation, blood products used in the first 24\u2009hours post-surgery, time of fitness for discharge, valve and heart function 6 months post-surgery (assessed using cardiovascular magnetic resonance and ECHOCARDIOGRAPHY) and health-related quality of life 6 weeks and 6 months post-surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034086', 'cui_str': 'Pulmonary Valve'}]","[{'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0190129', 'cui_str': 'Replacement of pulmonary valve'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0449885', 'cui_str': 'Blood product used (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C4521692', 'cui_str': 'Cardiac physiological function (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",,0.191597,"Valve replacement with 'injectable' self-expanding valves (which is performed 'off pump' without the use of cardiopulmonary bypass, CPB) may result in quicker recovery and lower risk of major complications than valve replacement with conventional valves (which is performed 'on pump' with the use of CPB).
","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Heys', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Angelini', 'Affiliation': 'Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pufulete', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Parry', 'Affiliation': 'Bristol Heart Institute, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2018-026221']
243,32314132,"Randomized Trial of Reverse Colocated Integrated Care on Persons with Severe, Persistent Mental Illness in Southern Texas.","BACKGROUND


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


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


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


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


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


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


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


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


clinicaltrials.gov , Identifier: NCT03881657.",2020,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"['Participants were recruited at a clinic between November 24, 2015, and June 30, 2016', 'chronically ill adults', 'persons with SPMI and co-morbid chronic disease in a US-Mexico border community', '416 participants', 'persons with SPMI and co-morbid chronic disease receiving behavioral health services at a local mental health authority located at the US-Mexico border', 'Persons with severe, persistent mental illness (SPMI', 'population with SPMI in a socioeconomically distressed region of the USA', 'Persons with Severe, Persistent Mental Illness in Southern Texas']","['reverse colocated integrated care', 'Receipt of at least two visits with a primary care provider and at least one visit with a chronic care nurse or dietician, compared with usual care (behavioral health only', 'Reverse Colocated Integrated Care', 'reverse colocated integrated care intervention', 'usual care']","['adverse effects', 'blood pressure', 'health outcomes', 'HbA1c, BMI, total cholesterol, and depressive symptoms', 'blood pressure and HbA1c', 'systolic blood pressure', 'diastolic blood pressure']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",416.0,0.130521,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"[{'ForeName': 'Karen Sautter', 'Initials': 'KS', 'LastName': 'Errichetti', 'Affiliation': 'Department of Movement Arts, Health Promotion and Leisure Studies, Bridgewater State University, 325 Plymouth Street, Bridgewater, MA, 02325, USA. ksautter@gmail.com.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Gaitan', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'M Marlen', 'Initials': 'MM', 'LastName': 'Ramirez', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05778-2']
244,31629373,Infrared thermography and ulcer prevention in the high-risk diabetic foot: data from a single-blind multicentre controlled clinical trial.,"AIM


To assess the usefulness of monthly thermography and standard foot care to reduce diabetic foot ulcer recurrence.
METHODS


People with diabetes (n = 110), neuropathy and history of ≥ 1 foot ulcer participated in a single-blind multicentre clinical trial. Feet were imaged with a novel thermal imaging device (Diabetic Foot Ulcer Prevention System). Participants were randomized to intervention (active thermography + standard foot care) or control (blinded thermography + standard foot care) and were followed up monthly until ulcer recurrence or for 12 months. Foot thermograms of participants from the intervention group were assessed for hot spots (areas with temperature ≥ 2.2°C higher than the corresponding contralateral site) and acted upon as per local standards.
RESULTS


After 12 months, 62% of participants were ulcer-free in the intervention group and 56% in the control group. The odds ratios of ulcer recurrence (intervention vs control) were 0.82 (95% CI 0.38, 1.8; P = 0.62) and 0.55 (95% CI 0.21, 1.4; P = 0.22) in univariate and multivariate logistic regression analyses, respectively. The hazard ratios for the time to ulcer recurrence (intervention vs control) were 0.84 (95% CI 0.45, 1.6; P = 0.58) and 0.67 (95% CI 0.34, 1.3; P = 0.24) in univariate and multivariate Cox regression analyses, respectively.
CONCLUSIONS


Monthly intervention with thermal imaging did not result in a significant reduction in ulcer recurrence rate or increased ulcer-free survival in this cohort at high risk of foot ulcers. This trial has, however, informed the design of a refined study with longer follow-up and group stratification, further aiming to assess the efficacy of thermography to reduce ulcer recurrence.",2020,"CONCLUSIONS


Monthly intervention with thermal imaging did not result in a significant reduction in ulcer recurrence rate or increased ulcer-free survival in this cohort at high risk of foot ulcers.","['People with diabetes (n=110), neuropathy and history of ≥1 foot ulcer participated in a single-blind multicentre clinical trial']","['Infrared thermography and ulcer prevention', 'monthly thermography and standard foot care', 'intervention (active thermography + standard foot care) or control (blinded thermography + standard foot care']","['ulcer-free', 'odds ratios of ulcer recurrence', 'hazard ratios for the time to ulcer recurrence', 'ulcer recurrence rate or increased ulcer-free survival', 'ulcer recurrence']","[{'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0085119', 'cui_str': 'Foot Ulcer'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0039810', 'cui_str': 'Temperature Mapping'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0769166,"CONCLUSIONS


Monthly intervention with thermal imaging did not result in a significant reduction in ulcer recurrence rate or increased ulcer-free survival in this cohort at high risk of foot ulcers.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Petrova', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Donaldson', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': 'Microvascular Diagnostics, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Microvascular Diagnostics, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lomas', 'Affiliation': 'Podiatry Department, Diabetes Centre, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Leech', 'Affiliation': 'Podiatry Department, Diabetes Centre, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ainarkar', 'Affiliation': 'Community Podiatry Department, Pennine Acute Hospitals Trust, Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bevans', 'Affiliation': 'Community Podiatry Department, Pennine Acute Hospitals Trust, Manchester, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Plassmann', 'Affiliation': 'Photometrix Imaging Ltd, Pontypridd, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kluwe', 'Affiliation': 'Department of Computing, University of South Wales, Pontypridd, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ring', 'Affiliation': 'Department of Computing, University of South Wales, Pontypridd, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Whittam', 'Affiliation': 'Temperature and Humidity, National Physical Laboratory, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': 'Temperature and Humidity, National Physical Laboratory, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McMillan', 'Affiliation': 'Temperature and Humidity, National Physical Laboratory, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Simpson', 'Affiliation': 'Temperature and Humidity, National Physical Laboratory, London, UK.'}, {'ForeName': 'A N A', 'Initials': 'ANA', 'LastName': 'Donaldson', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Machin', 'Affiliation': 'Temperature and Humidity, National Physical Laboratory, London, UK.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Edmonds', 'Affiliation': ""Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, UK.""}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14152']
245,32309986,Symptoms improve after a yoga program designed for PTSD in a randomized controlled trial with veterans and civilians.,"OBJECTIVE


Although yoga shows promise as a treatment for posttraumatic stress disorder (PTSD), there are few randomized controlled trials that demonstrate significant benefits for individuals with PTSD. The present study addresses this need by comparing the effects of a holistic yoga program (HYP) to that of a wellness lifestyle program (WLP) on PTSD symptom severity with a randomized clinical trial.
METHOD


The sample consisted of 209 participants (91.4% veterans; 66% male; 61.7% White) who met diagnostic criteria for PTSD at baseline. Participants were randomly assigned to attend one of the 2 weekly interventions for 16 weeks. The HYP consisted of yoga instruction, while the WLP consisted of didactics, discussions, and walking. PTSD severity was measured using the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5).
RESULTS


Analyses revealed that the HYP reduced PTSD severity measured by the CAPS-5 significantly more than the WLP at treatment end (mean difference = -5.4, effect size = 0.46,  p  < .001), but not at 7-month follow up (mean difference = -0.9,  p  = .603). Similarly, the HYP reduced PTSD severity measured by the PCL-5 significantly more than the WLP at treatment end (difference = -6.0,  p  = .001), but not at 7-month follow up (mean difference = -1.0,  p  = .682).
CONCLUSION


Yoga may be an effective intervention for PTSD in addition to standard treatments. Future yoga trials should consider adding a social component to interventions or booster classes to maintain effects long term. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Analyses revealed that the HYP reduced PTSD severity measured by the CAPS-5 significantly more than the WLP at treatment end (mean difference = -5.4, effect size = 0.46,  p  < .001), but not at 7-month follow up (mean difference = -0.9,  p  = .603).","['individuals with PTSD', '209 participants (91.4% veterans; 66% male; 61.7% White) who met diagnostic criteria for PTSD at baseline', 'posttraumatic stress disorder (PTSD']","['holistic yoga program (HYP', 'WLP', 'wellness lifestyle program (WLP']","['PTSD severity', 'Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}]",209.0,0.0266753,"RESULTS


Analyses revealed that the HYP reduced PTSD severity measured by the CAPS-5 significantly more than the WLP at treatment end (mean difference = -5.4, effect size = 0.46,  p  < .001), but not at 7-month follow up (mean difference = -0.9,  p  = .603).","[{'ForeName': 'Louanne W', 'Initials': 'LW', 'LastName': 'Davis', 'Affiliation': 'Department of Research, Roudebush Veterans Affairs Medical Center.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Department of Occupational Therapy, Colorado State University.'}, {'ForeName': 'Joanne K', 'Initials': 'JK', 'LastName': 'Daggy', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': ""O'Connor"", 'Affiliation': 'Veterans Affairs Health Services Research and Development Service Center for Health Information and Communication, Roudebush Veterans Affairs Medical Center.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Schalk', 'Affiliation': 'Heartland Yoga Therapy.'}, {'ForeName': 'Ai-Nghia L', 'Initials': 'AL', 'LastName': 'Do', 'Affiliation': 'Veterans Affairs Health Services Research and Development Service Center for Health Information and Communication, Roudebush Veterans Affairs Medical Center.'}, {'ForeName': 'Danka', 'Initials': 'D', 'LastName': 'Maric', 'Affiliation': 'Department of Psychological Science, Ball State University.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lazarick', 'Affiliation': 'Department of Psychiatry, Roudebush Veterans Affairs Medical Center.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Knock', 'Affiliation': 'Department of Psychiatry, Roudebush Veterans Affairs Medical Center.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000564']
246,32244111,Glucocorticoids and cortical decoding in the phobic brain.,"Glucocorticoids reduce phobic fear in anxiety disorders and enhance psychotherapy, possibly by reducing the retrieval of fear memories and enhancing the consolidation of new corrective memories. Glucocorticoid signaling in the basolateral amygdala can influence connected fear and memory-related cortical regions, but this is not fully understood. Previous studies investigated specific pathways moderated by glucocorticoids, for example, visual-temporal pathways; however, these analyses were limited to a-priori selected regions. Here, we performed whole-brain pattern analysis to localize phobic stimulus decoding related to the fear-reducing effect of glucocorticoids. We reanalyzed functional magnetic resonance imaging (fMRI) data from a previously published study with spider-phobic patients and healthy controls. The patients received glucocorticoids or a placebo before the exposure to spider images. There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls. Decoding in the ACC and the right insula showed strong evidence for correlation with experienced fear. Patients with cortisol reported a reduction of fear by 10-13%; however, there was only weak evidence for changes in neural decoding compared to placebo which was found in the precuneus, the opercular cortex, and the left cerebellum.",2020,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,['spider-phobic patients and healthy controls'],"['placebo', 'glucocorticoids', 'Glucocorticoids', 'glucocorticoids or a placebo', 'functional magnetic resonance imaging (fMRI']","['neural decoding', 'reduction of fear']","[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0236284,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schwab', 'Affiliation': 'Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Population Health, University of Oxford, United Kingdom; Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland. Electronic address: simon.schwab@uzh.ch.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Federspiel', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland; Japan Science and Technology Agency, PRESTO, Saitama, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Nakataki', 'Affiliation': 'Department of Psychiatry, University of Tokushima, Tokushima, Japan.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Strik', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Dept. of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany; Freiburg Brain Imaging Center, University Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Quervain', 'Affiliation': 'Division of Cognitive Neuroscience, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Leila M', 'Initials': 'LM', 'LastName': 'Soravia', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111066']
247,32251729,The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design.,"OBJECTIVE


Colchicine has been utilized safely in a variety of cardiovascular clinical conditions. Among its potential mechanisms of action is the non-selective inhibition of NLRP3 inflammasome which is thought to be a major pathophysiologic component in the clinical course of patients with COVID-19. GRECCO-19 will be a prospective, randomized, open-labeled, controlled study to assess the effects of colchicine in COVID-19 complications prevention.
METHODS


Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical picture that involves temperature >37.5 oC and at least two out of the: i. sustained coughing, ii. sustained throat pain, iii. Anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg will be included. Patients will be randomised (1:1) in colchicine or control group.
RESULTS


Trial results will be disseminated through peer-reviewed publications and conference presentations.
CONCLUSION


GRECCO-19 trial aims to identify whether colchicine may positively intervene in the clinical course of COVID-19. (ClinicalTrials.gov Identifier: NCT04326790).",2020,"Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical picture that involves temperature >37.5 oC and at least two out of the: i. sustained coughing, ii. sustained throat pain, iii.",['Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR'],"['colchicine', 'Colchicine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}]",[],,0.120551,"Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical picture that involves temperature >37.5 oC and at least two out of the: i. sustained coughing, ii. sustained throat pain, iii.","[{'ForeName': 'Spyridon G', 'Initials': 'SG', 'LastName': 'Deftereos', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece. Electronic address: spdeftereos@gmail.com.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Siasos', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannopoulos', 'Affiliation': 'General Hospital of Athens ""G.Gennimatas"" Hospital, Athens, Greece.'}, {'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Vrachatis', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece; Humanitas Clinical and Research Institute, Rozzano, Milan, Italy.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Angelidis', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sotiria G', 'Initials': 'SG', 'LastName': 'Giotaki', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Gargalianos', 'Affiliation': 'Athens Medical Center, Athens, Greece.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Giamarellou', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece; Therapeutirion Hygeia, Athens, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Gogos', 'Affiliation': 'Medical School, University of Patras, Patra, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Daikos', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece; Mitera Hospital, Athens, Greece.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Lazanas', 'Affiliation': 'Metropolitan General Hospital, Athens, Greece.'}, {'ForeName': 'Pagona', 'Initials': 'P', 'LastName': 'Lagiou', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Saroglou', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece; Metropolitan Hospital, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Sipsas', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsiodras', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Chatzigeorgiou', 'Affiliation': 'Hellenic Air Force General Staff.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Moussas', 'Affiliation': 'Athens Medical Center, Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Kotanidou', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Koulouris', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Oikonomou', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kaoukis', 'Affiliation': 'General Hospital of Athens ""G.Gennimatas"" Hospital, Athens, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Kossyvakis', 'Affiliation': 'General Hospital of Athens ""G.Gennimatas"" Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Raisakis', 'Affiliation': 'General Hospital of Athens ""G.Gennimatas"" Hospital, Athens, Greece.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Fountoulaki', 'Affiliation': 'General Hospital of Elefsina ""Thriasio"", Elefsina, Greece.'}, {'ForeName': 'Mihalis', 'Initials': 'M', 'LastName': 'Comis', 'Affiliation': 'General Hospital of Elefsina ""Thriasio"", Elefsina, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tsiachris', 'Affiliation': 'Athens Medical Center, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Sarri', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Theodorakis', 'Affiliation': 'Missolonghi General Hospital ""Chatzikosta"", Missolonghi, Greece.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martinez-Dolz', 'Affiliation': 'Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sanz-Sánchez', 'Affiliation': 'Humanitas Clinical and Research Institute, Rozzano, Milan, Italy; Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reimers', 'Affiliation': 'Humanitas Clinical and Research Institute, Rozzano, Milan, Italy.'}, {'ForeName': 'Giulio G', 'Initials': 'GG', 'LastName': 'Stefanini', 'Affiliation': 'Humanitas Clinical and Research Institute, Rozzano, Milan, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cleman', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Filippou', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christoforos D', 'Initials': 'CD', 'LastName': 'Olympios', 'Affiliation': 'General Hospital of Elefsina ""Thriasio"", Elefsina, Greece.'}, {'ForeName': 'Vlasios N', 'Initials': 'VN', 'LastName': 'Pyrgakis', 'Affiliation': 'General Hospital of Athens ""G.Gennimatas"" Hospital, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goudevenos', 'Affiliation': 'University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hahalis', 'Affiliation': 'Medical School, University of Patras, Patra, Greece.'}, {'ForeName': 'Theofilos M', 'Initials': 'TM', 'LastName': 'Kolettis', 'Affiliation': 'University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christodoulos', 'Initials': 'C', 'LastName': 'Stefanadis', 'Affiliation': 'Medical School, National & Kapodistrian University of Athens, Athens, Greece; Athens Medical Center, Athens, Greece.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2020.03.002']
248,32037021,Reducing Both Food Insecurity and Excess Body Weight in Costa Rican Women: A Cluster Randomized Trial.,"INTRODUCTION


The coexistence of food insecurity and excess body weight has been well documented in women. Both food insecurity and excess body weight have multiple consequences for physical and mental health. Concerns have been raised about interventions aimed to reduce food insecurity because these interventions might contribute to excess body weight, particularly in adult women. The purpose of this study was to develop, implement, and evaluate an intervention to simultaneously reduce food insecurity and body weight through alleviating discouragement-which women described as feeling sad, depressed, hopeless, and lacking drive to do important activities, such as finding a job or studying more-by increasing women's empowerment.
STUDY DESIGN


This 2-armed cluster RCT was conducted from February to December 2017. Data were analyzed from January to July 2018.
SETTING/PARTICIPANTS


Participants were food-insecure women with excess body weight in the Central Canton of the province of Alajuela, Costa Rica.
INTERVENTION


The intensive intervention arm consisted of activities at the individual (12 sessions lasting 2 hours each, 3 follow-up monthly sessions, and 1 closing session), household (1 workshop with the participants' household and community members and homework with family participation), and community (2 brochures and 1 workshop) levels. The nonintensive control arm consisted of 3 sessions about healthy lifestyles lasting 1 hour each.
MAIN OUTCOME MEASURES


Outcome measures included BMI, waist circumference, and food insecurity.
RESULTS


A total of 171 participants were enrolled (83 in intensive and 88 in nonintensive control arms). At 6 months, the intensive arm had greater decreases from baseline in BMI (-0.648, p=0.019), waist circumference (-2.21, p=0.002), and food insecurity (-1.35, p=0.009) compared with the nonintensive control arm.
CONCLUSIONS


The intensive intervention was effective in simultaneously reducing food insecurity and excess body weight. Educational components should be added to interventions aimed to reduce food insecurity.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03492619.",2020,"At 6 months, the intensive arm had greater decreases from baseline in BMI (-0.648, p=0.019), waist circumference (-2.21, p=0.002), and food insecurity (-1.35, p=0.009) compared with the nonintensive control arm.
","['171 participants were enrolled (83 in intensive and 88 in nonintensive control arms', 'Participants were food-insecure women with excess body weight in the Central Canton of the province of Alajuela, Costa Rica', 'Costa Rican Women', 'adult women']","[""household (1 workshop with the participants' household and community members and homework with family participation), and community (2 brochures and 1 workshop) levels"", 'nonintensive control arm consisted of 3 sessions about healthy lifestyles lasting 1 hour each']","['food insecurity', 'BMI', 'BMI, waist circumference, and food insecurity', 'waist circumference']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0010182', 'cui_str': 'Costa Rica'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",171.0,0.0971826,"At 6 months, the intensive arm had greater decreases from baseline in BMI (-0.648, p=0.019), waist circumference (-2.21, p=0.002), and food insecurity (-1.35, p=0.009) compared with the nonintensive control arm.
","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Martínez-Jaikel', 'Affiliation': 'School of Nutrition, University of Costa Rica, San José, Costa Rica. Electronic address: tatimartinez@hotmail.com.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Blake', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Maryah S', 'Initials': 'MS', 'LastName': 'Fram', 'Affiliation': 'College of Social Work, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Esquivel-Solís', 'Affiliation': 'School of Nutrition, University of Costa Rica, San José, Costa Rica.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.11.021']
249,32042108,Interplay of chronotype and school timing predicts school performance.,"Most adolescents exhibit very late chronotypes and attend school early in the morning, a misalignment that can affect their health and psychological well-being. Here we examine how the interaction between the chronotype and school timing of an individual influences academic performance, studying a unique sample of 753 Argentinian students who were randomly assigned to start school in the morning (07:45), afternoon (12:40) or evening (17:20). Although chronotypes tend to align partially with class time, this effect is insufficient to fully account for the differences with school start time. We show that (1) for morning-attending students, early chronotypes perform better than late chronotypes in all school subjects, an effect that is largest for maths; (2) this effect vanishes for students who attend school in the afternoon; and (3) late chronotypes benefit from evening classes. Together, these results demonstrate that academic performance is improved when school times are better aligned with the biological rhythms of adolescents.",2020,"We show that (1) for morning-attending students, early chronotypes perform better than late chronotypes in all school subjects, an effect that is largest for maths; (2) this effect vanishes for students who attend school in the afternoon; and (3) late chronotypes benefit from evening classes.","['753 Argentinian students who were randomly assigned to start school in the morning (07:45), afternoon (12:40) or evening (17:20']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}]",[],[],753.0,0.0255991,"We show that (1) for morning-attending students, early chronotypes perform better than late chronotypes in all school subjects, an effect that is largest for maths; (2) this effect vanishes for students who attend school in the afternoon; and (3) late chronotypes benefit from evening classes.","[{'ForeName': 'Andrea P', 'Initials': 'AP', 'LastName': 'Goldin', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sigman', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Braier', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Golombek', 'Affiliation': 'Universidad Nacional de Quilmes, CONICET, Laboratorio de Cronobiología, Departamento de Ciencia y Tecnología, Buenos Aires, Argentina.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Leone', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina. mleone@utdt.edu.'}]",Nature human behaviour,['10.1038/s41562-020-0820-2']
250,31927654,Streamlined Prevention and Early Intervention for Pediatric Anxiety Disorders: A Randomized Controlled Trial.,"There is a need to optimize the fit between psychosocial interventions with known efficacy and the demands of real-word service delivery settings. However, adaptation of evidence-based interventions (EBI) raises questions about whether effectiveness can be retained. This randomized controlled trial (RCT) evaluated a streamlined package of cognitive, behavior, and social skills training strategies known to prevent and reduce anxiety symptom and disorder escalation in youth. A total of 109 youth (M age  = 9.72; 68% girls; 54% Latinx) at risk based on high anxiety were randomized to the streamlined prevention and early intervention (SPEI) (n = 59) or control (n = 50) and were assessed at pretest, posttest, and 12-month follow-up. A main objective was to determine whether our redesign could be delivered by community providers, with acceptable levels of fidelity, quality, and impact. In terms of process evaluation results, there was high protocol fidelity, excellent clinical process skills, few protocol adaptations, and high satisfaction with the SPEI. In terms of outcomes, there were no significant main or moderated effects of the SPEI at the immediate posttest. However, at the follow-up, youth in the SPEI reported greater self-efficacy for managing anxiety-provoking situations, greater social skills, and fewer negative cognitive errors relative to controls. Collectively, findings suggest that the redesigned SPEI might be an attractive and efficient solution for service delivery settings.",2020,"In terms of outcomes, there were no significant main or moderated effects of the SPEI at the immediate posttest.","['Pediatric Anxiety Disorders', 'A total of 109 youth (M age  = 9.72; 68% girls; 54% Latinx) at risk based on high anxiety', 'youth']","['streamlined prevention and early intervention (SPEI', 'Streamlined Prevention and Early Intervention']","['anxiety symptom and disorder escalation', 'self-efficacy']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",109.0,0.120043,"In terms of outcomes, there were no significant main or moderated effects of the SPEI at the immediate posttest.","[{'ForeName': 'Armando A', 'Initials': 'AA', 'LastName': 'Pina', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA. armando.pina@asu.edu.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Gonzales', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}, {'ForeName': 'Gina L', 'Initials': 'GL', 'LastName': 'Mazza', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Gunn', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Holly', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, WI, 53233, USA.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Stoll', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Chiapa', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wynne', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, 871104, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01066-6']
251,31836635,Cost-effectiveness of strategies preventing late-onset infection in preterm infants.,"OBJECTIVE


Developing a model to analyse the cost-effectiveness of interventions preventing late-onset infection (LOI) in preterm infants and applying it to the evaluation of anti-microbial impregnated peripherally inserted central catheters (AM-PICCs) compared with standard PICCs (S-PICCs).
DESIGN


Model-based cost-effectiveness analysis, using data from the Preventing infection using Antimicrobial Impregnated Long Lines (PREVAIL) randomised controlled trial linked to routine healthcare data, supplemented with published literature. The model assumes that LOI increases the risk of neurodevelopmental impairment (NDI).
SETTING


Neonatal intensive care units in the UK National Health Service (NHS).
PATIENTS


Infants born ≤32 weeks gestational age, requiring a 1 French gauge PICC.
INTERVENTIONS


AM-PICC and S-PICC.
MAIN OUTCOME MEASURES


Life expectancy, quality-adjusted life years (QALYs) and healthcare costs over the infants' expected lifetime.
RESULTS


Severe NDI reduces life expectancy by 14.79 (95% CI 4.43 to 26.68; undiscounted) years, 10.63 (95% CI 7.74 to 14.02; discounted) QALYs and costs £19 057 (95% CI £14 197; £24697; discounted) to the NHS. If LOI causes NDI, the maximum acquisition price of an intervention reducing LOI risk by 5% is £120. AM-PICCs increase costs (£54.85 (95% CI £25.95 to £89.12)) but have negligible impact on health outcomes (-0.01 (95% CI -0.09 to 0.04) QALYs), compared with S-PICCs. The NHS can invest up to £2.4 million in research to confirm that AM-PICCs are not cost-effective.
CONCLUSIONS


The model quantifies health losses and additional healthcare costs caused by NDI and LOI during neonatal care. Given these consequences, interventions preventing LOI, even by a small extent, can be cost-effective. AM-PICCs, being less effective and more costly than S-PICC, are not likely to be cost-effective.
TRIAL REGISTRATION NUMBER


NCT03260517.",2020,"Severe NDI reduces life expectancy by 14.79 (95% CI 4.43 to 26.68; undiscounted) years, 10.63","['Infants born ≤32 weeks gestational age, requiring a 1 French gauge PICC', 'preterm infants', 'Neonatal intensive care units in the UK National Health Service (NHS']",['standard PICCs (S-PICCs'],"['health outcomes', 'AM-PICCs increase costs', 'LOI risk', 'risk of neurodevelopmental impairment (NDI', ""Life expectancy, quality-adjusted life years (QALYs) and healthcare costs over the infants' expected lifetime"", 'Severe NDI reduces life expectancy']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0580793', 'cui_str': 'French gauge'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.142018,"Severe NDI reduces life expectancy by 14.79 (95% CI 4.43 to 26.68; undiscounted) years, 10.63","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Grosso', 'Affiliation': 'Centre for Health Economics, University of York, York, UK alessandro.grosso@york.ac.uk.'}, {'ForeName': 'Rita Isabel', 'Initials': 'RI', 'LastName': 'Neves de Faria', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bojke', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Donohue', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, Merseyside, UK.'}, {'ForeName': 'Caroline Isabel', 'Initials': 'CI', 'LastName': 'Fraser', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Harron', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Oddie', 'Affiliation': 'Bradford Neonatology, Bradford Royal Infirmary, West Yorkshire, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'MRC Centre of Epidemiology for Child Health, UCL Institute of Child Health, London, United Kingdom.'}]",Archives of disease in childhood,['10.1136/archdischild-2019-317640']
252,32067871,Cardiovascular Disease Guideline Adherence: An RCT Using Practice Facilitation.,"INTRODUCTION


Practice facilitation is a promising practice transformation strategy, but further examination of its effectiveness in improving adoption of guidelines for multiple cardiovascular disease risk factors is needed. The objective of the study is to determine whether practice facilitation is effective in increasing the proportion of patients meeting the Million Hearts ABCS outcomes: (A) aspirin when indicated, (B) blood pressure control, (C) cholesterol management, and (S) smoking screening and cessation intervention.
STUDY DESIGN


The study used a stepped-wedge cluster RCT design with 4 intervention waves. Data were extracted for 13 quarters between January 1, 2015 and March 31, 2018, which encompassed the control, intervention, and follow-up periods for all waves, and analyzed in 2019.
SETTING/PARTICIPANTS


A total of 257 small independent primary care practices in New York City were randomized into 1 of 4 waves.
INTERVENTION


The intervention consisted of practice facilitators conducting at least 13 practice visits over 1 year, focused on capacity building and implementing system and workflow changes to meet cardiovascular disease care guidelines.
MAIN OUTCOME MEASURES


The main outcomes were the Million Hearts' ABCS measures. Two additional measures were created: (1) proportion of tobacco users who received a cessation intervention (smokers counseled) and (2) a composite measure that assessed the proportion of patients meeting treatment targets for A, B, and C (ABC composite).
RESULTS


The S measure improved when comparing follow-up with the control period (incidence rate ratio=1.152, 95% CI=1.072, 1.238, p<0.001) and when comparing follow-up with intervention (incidence rate ratio=1.060, 95% CI=1.013, 1.109, p=0.007). Smokers counseled improved when comparing the intervention period with control (incidence rate ratio=1.121, 95% CI=1.037, 1.211, p=0.002).
CONCLUSIONS


Increasing the impact of practice facilitation programs that target multiple risk factors may require a longer, more intense intervention and greater attention to external policy and practice context.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02646488.",2020,"Smokers counseled improved when comparing the intervention period with control (incidence rate ratio=1.121, 95% CI=1.037, 1.211, p=0.002).
",['A total of 257 small independent primary care practices in New York City'],"['aspirin', 'cessation intervention', 'RCT', 'practice facilitators conducting at least 13 practice visits over 1 year, focused on capacity building and implementing system and workflow changes to meet cardiovascular disease care guidelines']","[""Million Hearts' ABCS measures""]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0671015,"Smokers counseled improved when comparing the intervention period with control (incidence rate ratio=1.121, 95% CI=1.037, 1.211, p=0.002).
","[{'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Shelley', 'Affiliation': 'Department of Policy and Public Health Management, College of Global Public Health, New York University, New York, New York. Electronic address: donna.shelley@nyu.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gepts', 'Affiliation': 'University of California Berkeley, Department of Sociology, Berkeley, California.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Siman', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, New York.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, New York.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cleland', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, New York.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Cuthel', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, NYU Langone Health, New York, New York.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Rogers', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, New York.'}, {'ForeName': 'Olugbenga', 'Initials': 'O', 'LastName': 'Ogedegbe', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, New York.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Pham-Singer', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, New York.'}, {'ForeName': 'Winfred', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, New York.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Berry', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, New York.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.12.013']
253,32305477,"Lower Ischemic Heart Disease Diagnostic Costs With Treadmill Stress CMR vs. SPECT: A Multicenter, Randomized Trial.",,2020,,[],['Treadmill Stress CMR vs. SPECT'],[],[],"[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]",[],,0.0703892,,"[{'ForeName': 'Subha V', 'Initials': 'SV', 'LastName': 'Raman', 'Affiliation': ''}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Hachamovitch', 'Affiliation': ''}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Scandling', 'Affiliation': ''}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Mazur', 'Affiliation': ''}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schelbert', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Vien', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': ''}, {'ForeName': 'Orlando P', 'Initials': 'OP', 'LastName': 'Simonetti', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2020.02.020']
254,31734103,"Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial.","BACKGROUND


More than a third of patients with epilepsy are treatment resistant, and thus new, more effective therapies to achieve seizure freedom are needed. Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models. We aimed to evaluate the safety, efficacy, and tolerability of adjunctive cenobamate in patients with uncontrolled focal (partial)-onset epilepsy.
METHODS


We did a multicentre, double-blind, randomised, placebo-controlled, dose-response study at 107 epilepsy and neurology centres in 16 countries. Adult patients (aged 18-70 years) with focal seizures despite treatment with 1-3 antiepileptic drugs were randomly assigned (1:1:1:1) via an interactive web response system, by block sizes of 4 within each country, to adjuvant once daily oral cenobamate at dose groups of 100 mg, 200 mg, or 400 mg, or placebo following an 8-week baseline assessment. Patients, investigators, and study personnel were masked to treatment assignment. The study included a 6-week titration phase and 12-week maintenance phase. The primary efficacy outcomes were percentage change in 28-day focal seizure frequency (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizures) from baseline analysed in the modified intention-to-treat population (≥1 dose and any post-baseline seizure data) and responder rates (≥50% reduction) analysed in the maintenance phase population (≥1 dose in the maintenance phase and any maintenance phase seizure data). The primary efficacy outcomes were analysed using a hierarchal step-down procedure comparing 200 mg versus placebo, 400 mg versus placebo, then 100 mg versus placebo. Safety and tolerability were compared descriptively across treatment groups for all randomised patients. This study is registered with ClinicalTrials.gov, number NCT01866111.
FINDINGS


Between July 31, 2013, and June 22, 2015, 437 patients were randomly assigned to either placebo (n=108) or cenobamate 100 mg (n=108), 200 mg (n=110), or 400 mg (n=111). Of these patients, 434 (106 [98%] in placebo group, 108 [100%] in 100 mg group, 109 [99%] in 200 mg group, and 111 [100%] in 400 mg group) were included in the modified intention-to-treat population, and 397 (102 [94%] in placebo group, 102 [94%] in 100 mg group, 98 [89%] in 200 mg group, and 95 [86%] in 400 mg group) were included in the modified intention-to-treat maintenance phase population. Median percentage changes in seizure frequency were -24·0% (IQR -45·0 to -7·0%) for the placebo group compared with -35·5% (-62·5 to -15·0%; p=0·0071) for the 100 mg dose group, -55·0% (-73·0 to -23·0%; p<0·0001) for the 200 mg dose group, and -55·0% (-85·0 to -28·0%; p<0·0001) for the 400 mg dose group. Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group. Treatment-emergent adverse events occurred in 76 (70%) of 108 patients in the placebo group, 70 (65%) of 108 in the 100 mg group, 84 (76%) of 110 in the 200 mg group, and 100 (90%) of 111 in the 400 mg group. Treatment-emergent adverse events led to discontinuation in five (5%) patients in the placebo group, 11 (10%) in the 100 mg dose group, 15 (14%) in the 200 mg dose group, and 22 (20%) in the 400 mg dose group. One serious case of drug reaction with eosinophilia and systemic symptoms occurred in the 200 mg cenobamate group. No deaths were reported.
INTERPRETATION


Adjunctive cenobamate reduced focal (partial)-onset seizure frequency, in a dose-related fashion. Treatment-emergent adverse events were most frequent in the highest dose group. Cenobamate appears to be an effective treatment option in patients with uncontrolled focal seizures.
FUNDING


SK Life Science.",2020,"Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group.","['107 epilepsy and neurology centres in 16 countries', 'Between July 31, 2013, and June 22, 2015, 437 patients', 'patients with uncontrolled focal (partial)-onset epilepsy', 'Adult patients (aged 18-70 years) with focal seizures despite treatment with 1-3 antiepileptic drugs', 'patients with uncontrolled focal seizures']","['placebo', 'Cenobamate (YKP3089', 'adjunctive cenobamate', 'adjunctive cenobamate (YKP3089', 'cenobamate']","['seizure frequency', 'adverse events', 'safety, efficacy, and tolerability', 'eosinophilia and systemic symptoms', 'Safety and efficacy', 'modified intention-to-treat population (≥1 dose and any post-baseline seizure data) and responder rates', 'percentage change in 28-day focal seizure frequency (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizures', 'Safety and tolerability', 'Responder rates']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}]",437.0,0.775707,"Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group.","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: gkrauss@jhmi.edu.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Department of General Epileptology, Bethel Epilepsy Centre, Mara Hospital, Bielefeld, Germany.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Adult Comprehensive Epilepsy Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Milanov', 'Affiliation': 'Neurology Clinic, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Milovanovic', 'Affiliation': 'Department for Epilepsies and Clinical Neurophysiology, Institute of Mental Health, Faculty for Special Education and Rehabilitation, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Department for Adults, Kork Epilepsy Center, Kehl-Kork, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'Medical Affairs, SK Life Science, Paramus, NJ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30399-0']
255,32306247,Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial.,"INTRODUCTION


This study aimed to evaluate the short-term cost-effectiveness of insulin degludec 200 units/mL (degludec) versus insulin glargine 300 units/mL (glargine U300) from a Dutch societal perspective.
METHODS


A previously published model estimated costs [2018 euros (EUR)] and effectiveness [quality-adjusted life years (QALYs)] with degludec compared with glargine U300 over a 1-year time horizon. The model captured hypoglycaemia rates and insulin dosing. Clinical outcomes were informed by CONCLUDE (NCT03078478), a head-to-head randomised controlled trial in insulin-experienced patients with type 2 diabetes.
RESULTS


Treatment with degludec was associated with mean annual cost savings (EUR 24.71 per patient) relative to glargine U300, driven by a lower basal insulin dose and lower severe hypoglycaemia rate with degludec compared with glargine U300. Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300. In sensitivity analyses, changes to the vast majority of model parameters did not materially affect model outcomes.
CONCLUSIONS


This short-term analysis, informed by the latest clinical trial evidence, demonstrated that degludec was a cost-effective treatment option relative to glargine U300. As such, our modelling analysis suggests that degludec would represent an efficient use of Dutch public healthcare resources in this patient population.",2020,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,[],"['Insulin Degludec Versus Insulin Glargine', 'insulin degludec 200\xa0units/mL (degludec) versus insulin glargine 300\xa0units/mL (glargine U300']","['severe hypoglycaemia rate', 'effectiveness [quality-adjusted life years (QALYs', 'Lower rates of non-severe nocturnal and severe hypoglycaemia', 'mean annual cost savings']",[],"[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.149607,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'University Hospital Llandough, Penarth, UK. marclyndon1@hotmail.com.'}, {'ForeName': 'Robert G J', 'Initials': 'RGJ', 'LastName': 'Moes', 'Affiliation': 'Novo Nordisk B.V., Alphen aan den Rijn, Netherlands.'}, {'ForeName': 'Katrine S', 'Initials': 'KS', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk Region Europe, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gundgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}]",Advances in therapy,['10.1007/s12325-020-01332-y']
256,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


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


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


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


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
257,31399480,Feasibility of automated insulin delivery guided by continuous glucose monitoring in preterm infants.,"OBJECTIVE


Closed-loop systems have been used to optimise insulin delivery in children with diabetes, but they have not been tested in neonatal intensive care. Extremely preterm infants are prone to hyperglycaemia and hypoglycaemia; both of which have been associated with adverse outcomes. Insulin sensitivity is notoriously variable in these babies and glucose control is time-consuming, with management requiring frequent changes of dextrose-containing fluids and careful monitoring of insulin treatment. We aimed to evaluate the feasibility of closed-loop management of glucose control in these infants.
DESIGN AND SETTING


Single-centre feasibility study with a randomised parallel design in a neonatal intensive care unit. Eligibility criteria included birth weight <1200 g and <48 hours of age. All infants had subcutaneous continuous glucose monitoring for the first week of life, with those in the intervention group receiving closed-loop insulin delivery in a prespecified window, between 48 and 72 hours of age during which time the primary outcome was percentage of time in target (sensor glucose 4-8 mmol/L).
RESULTS


The mean (SD) gestational age and birth weight of intervention and control study arms were 27.0 (2.4) weeks, 962 (164) g and 27.5 (2.8) weeks, 823 (282) g, respectively, and were not significantly different. The time in target was dramatically increased from median (IQR) 26% (6-64) with paper guidance to 91% (78-99) during closed loop (p<0.001). There were no serious adverse events and no difference in total insulin infused.
CONCLUSIONS


Closed-loop glucose control based on subcutaneous glucose measurements appears feasible as a potential method of optimising glucose control in extremely preterm infants.",2020,"There were no serious adverse events and no difference in total insulin infused.
","['children with diabetes', 'Eligibility criteria included birth weight <1200\u2009g and <48\u2009hours of age', 'Single-centre feasibility study with a randomised parallel design in a neonatal intensive care unit', 'preterm infants', 'extremely preterm infants']",['automated insulin delivery guided by continuous glucose monitoring'],"['serious adverse events', 'total insulin infused', 'Insulin sensitivity', 'mean (SD) gestational age and birth weight', 'subcutaneous continuous glucose monitoring', 'percentage of time in target (sensor glucose']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.141324,"There were no serious adverse events and no difference in total insulin infused.
","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Beardsall', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge Biomedical Campus, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge Biomedical Campus, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Elleri', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge Biomedical Campus, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge Biomedical Campus, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge Biomedical Campus, Cambridge, Cambridgeshire, UK.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-316871']
258,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
259,31371434,Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.,"OBJECTIVE


To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth.
DESIGN


Parallel group randomised (1:1) trial.
SETTING


Eight UK tertiary maternity units.
PARTICIPANTS


Two hundred and seventy-six babies born to 261 women expected to have a live birth before 32 +0  weeks' gestation.
INTERVENTIONS


Deferred cord clamping (≥2 min) and immediate neonatal care with cord intact or immediate (≤20 s) clamping and immediate neonatal care after clamping.
MAIN OUTCOME MEASURE


Composite of death or adverse neurodevelopmental outcome at 2 years corrected age.
RESULTS


Six babies born after 35 +6  weeks were excluded. At 2 years corrected age, outcome data were not available for a further 52 children, leaving 218 for analysis (115 deferred clamping, 103 immediate clamping). Overall, 24/115 (21%) children allocated deferred clamping died or had an adverse neurodevelopmental outcome compared with 35/103 (34%) allocated immediate clamping; risk ratio (RR) 0.61 (95% CI 0.39 to 0.96); risk difference (RD) -13% (95% CI -25% to -1%). Multiple imputation for missing data gave an RR 0.69 (95% CI 0.44 to 1.09) and RD -9% (95% CI -21% to 2%).
CONCLUSIONS


Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature. Confirmation in larger studies is needed to determine the real benefits and harms.
TRIAL REGISTRATION NUMBER


ISRCTN21456601.",2020,Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature.,"['Six babies born after 35 +6  weeks were excluded', 'Eight UK tertiary maternity units', 'at very preterm birth', ""Two hundred and seventy-six babies born to 261 women expected to have a live birth before 32 +0  weeks' gestation"", 'children born very premature', '2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth']","['Deferred cord clamping (≥2\u2009min) and immediate neonatal care with cord intact or immediate (≤20\u2009s) clamping and immediate neonatal care after clamping', 'cord clamping', 'Deferred clamping and immediate neonatal care with cord intact']","['Composite of death or adverse neurodevelopmental outcome at 2 years corrected age', 'risk of death or adverse neurodevelopmental outcome', 'adverse neurodevelopmental outcome']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0565824', 'cui_str': 'Born very premature (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",261.0,0.315371,Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature.,"[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Armstrong-Buisseret', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Powers', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bradshaw', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Mitchell', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lelia', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-316912']
260,31687984,Effects of Elastic Resistance Exercise After Total Knee Replacement on Muscle Mass and Physical Function in Elderly Women With Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


Knee osteoarthritis and age are associated with high sarcopenia risk, especially in patients who have received total knee replacement. The aim of this study was to identify the effects of elastic resistance exercise training after total knee replacement on muscle mass and physical outcomes in older women with knee osteoarthritis.
DESIGN


Sixty older women who received unilateral primary total knee replacement surgery were randomized to an experimental group, which received 12 wks of postoperative elastic resistance exercise training, or a control group, which received standard care. The outcome measures included physical function performance (ie, Timed Up & Go, gait speed, forward reach, single-leg stance, timed chair rise), appendicular lean mass, and the Western Ontario and McMaster Universities Osteoarthritis Index. The assessment time points were 2 wks before surgery (T0), 1 mo after surgery (T1, before resistance exercise training), and 4 mos after surgery (T2, upon completion of resistance exercise training).
RESULTS


After 12 wks of postoperative elastic resistance exercise training, the experimental group exhibited a significantly greater change in appendicular lean mass (mean difference = 0.81 kg, P = 0.004) than the control group. Elastic resistance exercise training also exerted significant effects on Timed Up & Go and gait speed with mean differences of 0.28 m/sec (P < 0.001) and -2.66 secs (P < 0.001), respectively.
CONCLUSIONS


A 12-wk elastic resistance exercise training program after total knee replacement exerted benefits on muscle mass, mobility, and Western Ontario and McMaster Universities Osteoarthritis Index functional outcomes in older women with knee osteoarthritis.",2020,"A 12-week elastic RET program after TKR exerted benefits on muscle mass, mobility, and WOMAC functional outcomes in older women with KOA.","['older women with KOA', 'elderly women with osteoarthritis', 'older women with KOA.Sixty older women who received unilateral primary TKR surgery', 'patients who have received total knee replacement (TKR']","['postoperative elastic RET, or a control group (CG), which received standard care', 'TKR', 'elastic resistance exercise training (RET', 'elastic resistance exercise']","['muscle mass and physical outcomes', 'physical function performance (i.e., Timed Up & Go [TUG], gait speed [GS], forward reach, single-leg stance, timed chair rise), appendicular lean mass (ALM), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC', 'muscle mass and physical function', 'muscle mass, mobility, and WOMAC functional outcomes', 'ALM']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0379555,"A 12-week elastic RET program after TKR exerted benefits on muscle mass, mobility, and WOMAC functional outcomes in older women with KOA.","[{'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Liao', 'Affiliation': 'From the School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan (C-DL, J-YT); Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan (C-DL, S-WH, T-HL); Department of Orthopedics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan (Y-SC); Department of Radiology, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan (J-WK); Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan, Taiwan (S-WH); and Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan (S-WH, T-HL).'}, {'ForeName': 'Jau-Yih', 'Initials': 'JY', 'LastName': 'Tsauo', 'Affiliation': ''}, {'ForeName': 'Yen-Shuo', 'Initials': 'YS', 'LastName': 'Chiu', 'Affiliation': ''}, {'ForeName': 'Jan-Wen', 'Initials': 'JW', 'LastName': 'Ku', 'Affiliation': ''}, {'ForeName': 'Shih-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Tsan-Hon', 'Initials': 'TH', 'LastName': 'Liou', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001344']
261,31618539,Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.,"BACKGROUND


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


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


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


Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).",2019,"The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001).","['If patients were found to have reflux-related heartburn', '288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality', '366 patients (mean age, 48.5 years; 280 men) were enrolled', 'patients referred to VA gastroenterology clinics for PPI-refractory heartburn', 'Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of', 'twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring']","['desipramine', 'omeprazole', 'proton-pump inhibitor (PPI', 'surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo']","['Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score', 'incidence of treatment success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0014852', 'cui_str': 'Esophageal Diseases'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4302237', 'cui_str': 'Functional heartburn (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3834491', 'cui_str': 'Gastroenterology clinic (environment)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0192269', 'cui_str': 'Biopsy of esophagus (procedure)'}, {'cui': 'C0199873', 'cui_str': 'Esophageal manometry (procedure)'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}]","[{'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",288.0,0.117934,"The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Spechler', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Hunter', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Jones', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Smith', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mashimo', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Vivian M', 'Initials': 'VM', 'LastName': 'Sanchez', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Kerry B', 'Initials': 'KB', 'LastName': 'Dunbar', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Thai H', 'Initials': 'TH', 'LastName': 'Pham', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Uma K', 'Initials': 'UK', 'LastName': 'Murthy', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Taewan', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Jackson', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Wallen', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Erik C', 'Initials': 'EC', 'LastName': 'von Rosenvinge', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Pearl', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Laine', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaz', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Roger P', 'Initials': 'RP', 'LastName': 'Tatum', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Ziad F', 'Initials': 'ZF', 'LastName': 'Gellad', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Lagoo-Deenadayalan', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Rubenstein', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Ghaferi', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Wai-Kit', 'Initials': 'WK', 'LastName': 'Lo', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Fernando', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Bobby S', 'Initials': 'BS', 'LastName': 'Chan', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Shirley C', 'Initials': 'SC', 'LastName': 'Paski', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Provenzale', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Castell', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lieberman', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Rhonda F', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Warren', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davis-Karim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Melton', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Genta', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Serpi', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Huang', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa1811424']
262,32011378,Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.,"BACKGROUND


The risk of periprosthetic joint infection (PJI), a serious complication after arthroplasty, has not changed for years. Interventions such as eradication of Staphylococcus aureus and antibiotic bone cement are used to diminish infection risk but despite these efforts, the percentage of infection in TKA remains constant. Antimicrobial drapes have a dual action, acting both as a physical and antimicrobial barrier to counter bacterial contamination of the surgical wound. To study the effect of antimicrobial drapes, we used intraoperative contamination as a proxy for infection in our investigation.
QUESTIONS/PURPOSES


(1) Do antimicrobial surgical drapes reduce the risk of intraoperative microbial contamination in patients undergoing primary knee arthroplasty? (2) Are other factors such as sex, season, age, type of arthroplasty and duration of surgery associated with an increased risk of contamination in patients undergoing primary knee arthroplasty? (3) Does loosening of the antimicrobial drape increase contamination risk?
METHODS


An investigator-initiated, two-arm, non-blinded, multicenter, randomized, controlled trial was performed at five different hospitals in the capital and central regions of Denmark. Twenty-four surgeons participated in the study. Participants were patients older than 18 years undergoing primary knee arthroplasty. We excluded patients with an iodine allergy, previous open knee surgery, previous septic arthritis, any antibiotics taken 4 weeks before surgery, and if they were unable to understand the implications of study participation. Patients were randomly assigned to operation with an antimicrobial drape (intervention group) or operation without (control group). We screened 1769 patients, of which 100 were ineligible and 10 declined to participate. In all, 94% (1659 of 1769) of patients consented and were randomized to the intervention group (51%, 838 of 1659) and control group (49%, 821 of 1659), respectively. In all, 36% (603 of 1659) of patients in the intervention group and 35% (584 of 1659) patients in the control group were available for final analysis. No crossover was performed, and analysis was done per-protocol. Patients were excluded due to logistic failures like lack of utensils, samples disappearing en route to the laboratory mainly caused by implementation of a new electronic patient chart (EPIC, Verona, WI, USA), and forgetful surgeons. Intraoperatively, we swabbed for bacteria at the surgical site and in a rinse from the surgeons' gloves. All samples were sent for cultivation, and colony forming units (CFUs) counts ≥ 1 were deemed contaminated. The primary outcome measure was the difference in the proportion of contaminated patients between the two randomized groups. Secondary outcome measures were the affiliation of sex, season, age, type of implant used, and duration of surgery on contamination risk. To investigate whether other factors were affiliated with contamination risk, we did a logistic regression to control for confounding variables, including sex, age, season, type of implant and duration of surgery.
RESULTS


Use of iodinated drapes reduced contamination, with contamination detected in 10% (60 of 603) procedures where iodinated drapes were used compared with 15% (90 of 584) when they were not (odds ratio 0.61 [95% CI 0.43 to 0.87]; p = 0.005), with a relative risk reduction of 35% (95% CI 12.3 to 52.5) and a number needed to treat of 18 patients. After controlling for confounding variables such as sex, age, type of implant, and duration of surgery, we found that not using an antimicrobial drape increased contamination risk by a factor of 1.6 (95% CI 1.08 to 2.35; p = 0.02). Female sex and undergoing surgery in the central region were associated with lower odds of contamination (OR 0.55 [95% CI 0.39 to 0.8]; p = 0.002 and OR 0.45 [95% CI 0.25 to 0.8]; p = 0.006, respectively). Patients with more than a 10-mm separation of the drape from the skin had higher odds of contamination (OR 3.54 [95% CI 1.64 to 11.05]; p = 0.0013).
CONCLUSIONS


The use of an antimicrobial drape resulted in lower contamination risk than operating without an antimicrobial drape. Our findings suggest that antimicrobial drapes are useful in infection prevention, but further studies are needed to investigate the effect of antimicrobial drapes on infection.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"RESULTS


Use of iodinated drapes reduced contamination, with contamination detected in 10% (60 of 603) procedures where iodinated drapes were used compared with 15% (90 of 584) when they were not (odds ratio 0.61 [95% CI 0.43 to 0.87]; p = 0.005), with a relative risk reduction of 35% (95% CI 12.3 to 52.5) and a number needed to treat of 18 patients.","['Participants were patients older than 18 years undergoing primary knee arthroplasty', '1187 Patients', 'patients undergoing primary knee arthroplasty', 'Twenty-four surgeons participated in the study', 'Patients were excluded due to logistic failures like lack of utensils, samples disappearing en route to the laboratory mainly caused by implementation of a new electronic patient chart (EPIC, Verona, WI, USA), and forgetful surgeons', '1769 patients, of which 100 were ineligible and 10 declined to participate', 'patients with an iodine allergy, previous open knee surgery, previous septic arthritis, any antibiotics taken 4 weeks before surgery']","['antimicrobial drape (intervention group) or operation without (control group', 'antimicrobial surgical drapes']","['lower contamination risk', 'affiliation of sex, season, age, type of implant used, and duration of surgery on contamination risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1268547', 'cui_str': 'Patient chart'}, {'cui': 'C0542476', 'cui_str': 'Forgetful (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0571818', 'cui_str': 'Iodine allergy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C1692886', 'cui_str': 'Arthritis, Bacterial'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0180511', 'cui_str': 'Surgical Drapes'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449497', 'cui_str': 'Type of device (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",24.0,0.133429,"RESULTS


Use of iodinated drapes reduced contamination, with contamination detected in 10% (60 of 603) procedures where iodinated drapes were used compared with 15% (90 of 584) when they were not (odds ratio 0.61 [95% CI 0.43 to 0.87]; p = 0.005), with a relative risk reduction of 35% (95% CI 12.3 to 52.5) and a number needed to treat of 18 patients.","[{'ForeName': 'Anne Brun', 'Initials': 'AB', 'LastName': 'Hesselvig', 'Affiliation': 'A. B. Hesselvig, Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark; Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark A. Odgaard, Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark T. Bjarnsholt, Costerton Biofilm Center, Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark M. Arpi, Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark F. Madsen, Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Arpi', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Madsen', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bjarnsholt', 'Affiliation': ''}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Odgaard', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001142']
263,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
264,31177305,Symptoms and diagnostic delays in bladder cancer with high risk of recurrence: results from a prospective FinnBladder 9 trial.,"PURPOSE


To investigate the symptoms and delays in the clinical pathway of bladder cancer (BC).
METHODS


This is a substudy of a prospective, randomized, multicenter phase III study (FinnBladder 9, NCT01675219) where the efficacy of photodynamic diagnosis and 6 weekly optimized mitomycin C instillations are studied in pTa bladder cancer with high risk for recurrence. The data of presenting symptoms and critical time points were prospectively collected, and the effect of factors on delays was analyzed.
RESULTS


At the time of analysis, 245 patients were randomized. Analysis included 131 patients with primary bladder cancer and their complete data. Sixty-nine percent had smoking history and 67% presented with macroscopic hematuria. Median patient delay (from symptoms to health-care contact) was 7 days. The median general practice delay (from health-care contact to urology referral) was 8 days. Median time from urology referral to cystoscopy was 23 days and from cystoscopy to TUR-BT 21 days. Total time used in the clinical pathway (from symptom to TUR-BT) was 78 days. Current and former smokers had non-significantly shorter patient-related and general practice delays compared to never smokers. TUR-BT delay was significantly shorter in patients with malignant cytology (16 days) compared to patients with benign cytology (21 days, p = 0.03).
CONCLUSIONS


Patient-derived delay was short and most of the delay occurred in the referral centers. The majority had macroscopic hematuria as the initial symptom. Surprisingly, current and past smokers were more prone to contact the health-care system compared to never smokers.",2020,"TUR-BT delay was significantly shorter in patients with malignant cytology (16 days) compared to patients with benign cytology (21 days, p = 0.03).
","['Sixty-nine percent had smoking history and 67% presented with macroscopic hematuria', 'pTa bladder cancer with high risk for recurrence', '131 patients with primary bladder cancer and their complete data', 'bladder cancer with high risk of recurrence', '245 patients were randomized']",['photodynamic diagnosis and 6 weekly optimized mitomycin C instillations'],"['median general practice delay', 'TUR-BT delay', 'macroscopic hematuria', 'Total time', 'Median patient delay', 'Median time from urology referral to cystoscopy']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0473237', 'cui_str': 'Frank hematuria (disorder)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0473237', 'cui_str': 'Frank hematuria (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]",245.0,0.0353319,"TUR-BT delay was significantly shorter in patients with malignant cytology (16 days) compared to patients with benign cytology (21 days, p = 0.03).
","[{'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sell', 'Affiliation': 'Department of Urology, Turku University Hospital, Turku, Finland. ville.sell@gmail.com.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Ettala', 'Affiliation': 'Department of Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Montoya Perez', 'Affiliation': 'Department of Future Technology, University of Turku, Turku, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Järvinen', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tarmo', 'Initials': 'T', 'LastName': 'Pekkarinen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Vaarala', 'Affiliation': 'Department of Urology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Seppänen', 'Affiliation': 'Department of Surgery, Satakunta Central Hospital, Pori, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Liukkonen', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Marttila', 'Affiliation': 'Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Aaltomaa', 'Affiliation': 'Department of Urology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Kaasinen', 'Affiliation': 'Department of Surgery, Hospital of Hyvinkää, Hyvinkää, Finland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Boström', 'Affiliation': 'Department of Urology, Turku University Hospital, Turku, Finland.'}]",World journal of urology,['10.1007/s00345-019-02841-4']
265,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
266,32152372,Author Correction: A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"['Author Correction', 'children with cystic fibrosis']",['rosuvastatin'],['kidney toxicity'],"[{'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0366007,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'McWilliam', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, Merseyside, United Kingdom. stevemcw@liv.ac.uk.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shaw', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greenhalf', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Department of Mathematics and Statistics, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rosalind L', 'Initials': 'RL', 'LastName': 'Smyth', 'Affiliation': 'University College London, Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, and MRC Centre for Drug Safety Science, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}]",Scientific reports,['10.1038/s41598-020-61783-9']
267,32193269,Implementing a hybrid cognitive-behavioural therapy for pain-related insomnia in primary care: lessons learnt from a mixed-methods feasibility study.,"OBJECTIVES


To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia.
DESIGN


Mixed-methods, with qualitative process evaluation on a two-arm randomised controlled feasibility trial.
SETTING


Primary care.
PARTICIPANTS


Twenty-five adult patients with chronic pain and insomnia.
INTERVENTION


Hybrid CBT or self-help control intervention.
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary outcomes measures were the Insomnia Severity Index and interference scale of the Brief Pain Inventory (BPI). Secondary outcomes measures were the present pain intensity rating from the BPI, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and EQ-5D-5L.
RESULTS


Fourteen participants were randomised to receive Hybrid CBT, 11 to receive the self-help control treatment. Of the 14 in the Hybrid CBT group, 9 (64%) completed all four treatment sessions (4 discontinued due to poor health; 1 due to time constraints). Adherence to the self-help control treatment was not monitored. The total number of participants completing the 12-week and 24-week follow-ups were 12 (6 in each group; Hybrid CBT: 43%; self-help: 55%) and 10 (5 in each group; Hybrid CBT: 36%; self-help: 45%). Based on the data available, candidate outcome measures appeared to be sensitive to changes associated with interventions. Thematic analysis of pre-postintervention interview data revealed satisfaction with treatment content among those who completed the Hybrid CBT, whereas those in the self-help control treatment wanted more contact hours and therapist guidance. Other practical suggestions for improvement included shortening the duration of each treatment session, reducing the amount of assessment paperwork, and minimising the burden of sleep and pain monitoring.
CONCLUSION


Important lessons were learnt with regard to the infrastructure required to achieve better patient adherence and retention. Based on the qualitative feedback provided by a subset of treatment completers, future trials should also consider lowering the intensity of treatment and streamlining the data collection procedure.
TRIAL REGISTRATION NUMBER


ISRCTN17294365.",2020,"To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia.
","['pain-related insomnia in primary care', 'Twenty-five adult patients with chronic pain and insomnia', 'Fourteen participants', 'pain-related insomnia']","['Hybrid CBT', 'Hybrid CBT or self-help control intervention', 'intensive hybrid cognitive behavioural therapy (Hybrid CBT', 'hybrid cognitive-behavioural therapy']","['burden of sleep and pain monitoring', 'pain intensity rating from the BPI, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale and EQ-5D-5L', 'Insomnia Severity Index and interference scale of the Brief Pain Inventory (BPI']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]",25.0,0.0597483,"To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia.
","[{'ForeName': 'Nicole K Y', 'Initials': 'NKY', 'LastName': 'Tang', 'Affiliation': 'Department of Psychology, University of Warwick, Coventry, West Midlands, UK N.Tang@warwick.ac.uk.'}, {'ForeName': 'Corran', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Department of Psychology, University of Leicester, Leicester, Leicestershire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Harbinder Kaur', 'Initials': 'HK', 'LastName': 'Sandhu', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Ellard', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Vivien P', 'Initials': 'VP', 'LastName': 'Nichols', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}, {'ForeName': 'Victoria Elizabeth Janet', 'Initials': 'VEJ', 'LastName': 'Collard', 'Affiliation': 'Department of Psychology, University of Warwick, Coventry, West Midlands, UK.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Sharma', 'Affiliation': 'Patient Representative, Coventry, West Mindlands, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, West Midlands, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034764']
268,29381229,Time-to-event modelling of effect of codrituzumab on overall survival in patients with hepatocellular carcinoma.,"AIMS


Codrituzumab (GC33) is a recombinant, humanized mAb that binds to glypican-3 (GPC3), an oncofetal protein highly expressed in hepatocellular carcinoma (HCC). This investigation aimed to identify clinically relevant factors that may affect the overall survival (OS) in HCC patients treated with codrituzumab and to quantitatively annotate their effects.
METHODS


Codrituzumab exposure was estimated by a population pharmacokinetics model with a nonlinear elimination pathway. Analysis of OS was performed using a time-to-event model in 181 patients with advanced HCC. The model was tested with the addition of various covariates, including levels of immune biomarkers, such as CD16 (measured in terms of molecules of equivalent soluble fluorophore; CD16 MESF  ) and CD4, codrituzumab exposure and potential prognostic biomarkers of HCC such as baseline tumour size and soluble GPC3.
RESULTS


The time-to-event model estimated a prolonged OS (>3 months) in patients with codrituzumab exposure of ≥230 μg ml -1  and high CD16 MESF  level (>5.26 × 10 5  MESF at least). The Weibull model was selected as the base hazard model. The baseline tumour size was included in the hazard model as a parameter independent of the drug effect. A logistic model was applied to explain the effects of drug exposure and CD16 MESF  level.
CONCLUSIONS


The final model indicates that adequate drug exposure plus a favourable immune environment are associated with prolonged OS. This quantitative model should be further validated with emerging data so as to guide study design in future clinical trials.",2018,The time-to-event model estimated a prolonged OS (>3 months) in patients with codrituzumab exposure of ≥230 μg ml -1  and high CD16 MESF  level (>5.26 × 10 5  MESF at least).,"['181 patients with advanced HCC', 'HCC patients treated with', 'patients with hepatocellular carcinoma']","['codrituzumab', 'Codrituzumab (GC33']","['overall survival', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C4507381', 'cui_str': 'codrituzumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",181.0,0.043172,The time-to-event model estimated a prolonged OS (>3 months) in patients with codrituzumab exposure of ≥230 μg ml -1  and high CD16 MESF  level (>5.26 × 10 5  MESF at least).,"[{'ForeName': 'Mikiko', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Translational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Translational and Clinical Research Center, Hoffmann-La Roche Inc., New York City, USA.'}, {'ForeName': 'Cheikh', 'Initials': 'C', 'LastName': 'Diack', 'Affiliation': 'Clinical Pharmacology, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Ohishi', 'Affiliation': 'Translational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Ruey-Min', 'Initials': 'RM', 'LastName': 'Lee', 'Affiliation': 'Translational and Clinical Research Center, Hoffmann-La Roche Inc., New York City, USA.'}, {'ForeName': 'Satofumi', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Translational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Kawanishi', 'Affiliation': 'Translational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Ohtomo', 'Affiliation': 'Project Planning & Coordination Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ya-Chi', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Translational and Clinical Research Center, Hoffmann-La Roche Inc., New York City, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.13530']
269,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
270,32108274,Is the whole larger than the sum of its parts? Impact of missing data imputation in economic evaluation conducted alongside randomized controlled trials.,"Outcomes in economic evaluations, such as health utilities and costs, are products of multiple variables, often requiring complete item responses to questionnaires. Therefore, missing data are very common in cost-effectiveness analyses. Multiple imputations (MI) are predominately recommended and could be made either for individual items or at the aggregate level. We, therefore, aimed to assess the precision of both MI approaches (the item imputation vs. aggregate imputation) on the cost-effectiveness results. The original data set came from a cluster-randomized, controlled trial and was used to describe the missing data pattern and compare the differences in the cost-effectiveness results between the two imputation approaches. A simulation study with different missing data scenarios generated based on a complete data set was used to assess the precision of both imputation approaches. For health utility and cost, patients more often had a partial (9% vs. 23%, respectively) rather than complete missing (4% vs. 0%). The imputation approaches differed in the cost-effectiveness results (the item imputation: - 61,079€/QALY vs. the aggregate imputation: 15,399€/QALY). Within the simulation study mean relative bias (< 5% vs. < 10%) and range of bias (< 38% vs. < 83%) to the true incremental cost and incremental QALYs were lower for the item imputation compared to the aggregate imputation. Even when 40% of data were missing, relative bias to true cost-effectiveness curves was less than 16% using the item imputation, but up to 39% for the aggregate imputation. Thus, the imputation strategies could have a significant impact on the cost-effectiveness conclusions when more than 20% of data are missing. The item imputation approach has better precision than the imputation at the aggregate level.",2020,"For health utility and cost, patients more often had a partial (9% vs. 23%, respectively) rather than complete missing (4% vs. 0%).",[],[],"['true incremental cost and incremental QALYs', 'health utilities and costs, are products of multiple variables, often requiring complete item responses to questionnaires', 'cost-effectiveness conclusions']",[],[],"[{'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0336039,"For health utility and cost, patients more often had a partial (9% vs. 23%, respectively) rather than complete missing (4% vs. 0%).","[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Michalowsky', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Ellernholzstrasse 1-2, 17487, Greifswald, Germany. bernhard.michalowsky@dzne.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hoffmann', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Ellernholzstrasse 1-2, 17487, Greifswald, Germany.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact (Formerly Clinical Epidemiology and Biostatistics), McMaster University, 1280 Main Street West, Hamilton, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact (Formerly Clinical Epidemiology and Biostatistics), McMaster University, 1280 Main Street West, Hamilton, Canada.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-020-01166-z']
271,32162174,Sustained Impact on Parenting Practices: Year 7 Findings from the Healthy Families New York Randomized Controlled Trial.,"Prevention of maltreatment and harsh parenting are the primary goals of evidence-based home visiting programs, but rigorous studies demonstrating long-term outcomes are limited despite widespread implementation. The current study examines data from a 7-year follow-up study of a randomized controlled trial of Healthy Family New York (HFNY). Specifically, the study examines whether HFNY participation predicts lower rates of harsh and abusive parenting 7 years after enrollment. The data include both maternal self-report of parenting behaviors as well as the target child's report of harsh parenting. The year 7 sample included 942 mother interviews (83.5% retention from baseline) and 800 child interviews. At the 7-year follow-up, maternal-reported behaviors measured by CTS-PC showed a significantly increased use of positive parenting strategies and lower levels of serious physical abuse in the HFNY group compared with the control group. Significant group differences were observed for the frequency with which mothers engaged in severe or very severe physical assault (control group = .16, compared with .03 in the intervention group, p < .001). In addition, fewer children reported that their parents used minor physical assault. There was no intervention impact on indicated child protective service records. The current study indicates that home visiting participation reduces harsh and abusive parenting and promotes positive parenting behaviors that endure and may strengthen later development.",2020,"Significant group differences were observed for the frequency with which mothers engaged in severe or very severe physical assault (control group = .16, compared with .03 in the intervention group, p < .001).","['Healthy Family New York (HFNY', 'The year 7 sample included 942 mother interviews (83.5% retention from baseline) and 800 child interviews', 'Parenting Practices']",['HFNY'],"['severe or very severe physical assault', 'positive parenting strategies and lower levels of serious physical abuse']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0740319', 'cui_str': 'Physical assault'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}]",942.0,0.0728563,"Significant group differences were observed for the frequency with which mothers engaged in severe or very severe physical assault (control group = .16, compared with .03 in the intervention group, p < .001).","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kirkland', 'Affiliation': 'Bureau of Research, Evaluation and Performance Analytics, New York State Office of Children and Family Services, Rensselaer, NY, USA.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Center for Human Services Research, University at Albany, Albany, NY, USA. elee@albany.edu.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Center for Human Services Research, University at Albany, Albany, NY, USA.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Greene', 'Affiliation': 'Center for Human Services Research, University at Albany, Albany, NY, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01110-w']
272,32168058,Editor's Spotlight/Take 5: Does An Augmented Reality-based Portable Navigation System Improve the Accuracy of Acetabular Component Orientation During THA? A Randomized Controlled Trial.,,2020,,"[""Editor's Spotlight/Take 5""]",[],['Accuracy of Acetabular Component Orientation'],[],[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}]",,0.122553,,"[{'ForeName': 'Seth S', 'Initials': 'SS', 'LastName': 'Leopold', 'Affiliation': 'S. S. Leopold, Editor-in-Chief, Clinical Orthopaedics and Related Research®, Philadelphia, PA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001216']
273,31299343,Effect of concentrated growth factor (CGF) on short-term clinical outcomes after partially impacted mandibular third molar surgery: A split-mouth randomized clinical study.,"PURPOSE


The aim of this study was to evaluate the effectiveness of concentrated growth factor(CGF) on soft tissue healing and postoperative side effects following third molar surgery.
METHODS


This study was designed on 60 patients as a randomized single-blind clinical trial. The predictor variable was the implementation of CGF fibrin matrix, which was categorized as CGF and non-CGF. The primary outcome variable of the study was the healing of soft tissue around the extraction socket. The secondary outcome variables were pain, swelling and trismus. Data were analyzed using the non-parametric Brunner and Langer model. Statistical significance was set at P<.001.
RESULTS


Sixty patients (39 female, 21 male; mean age 25.82) with impacted mandibular third molars participated in the study. Statistical analysis revealed that there were significant differences between the control and test groups with regard to soft tissue healing, postoperative pain, swelling, and trismus (P<0.001).
CONCLUSION


The application of CGF accelerates soft tissue healing and is beneficial in minimising postoperative side effects, particularly pain, swelling and trismus, after extraction of mandibular third molars.
CLINICAL TRIALS NUMBER


NCT03913884.",2020,"Statistical analysis revealed that there were significant differences between the control and test groups with regard to soft tissue healing, postoperative pain, swelling, and trismus (P<0.001).
","['Sixty patients (39 female, 21 male; mean age 25.82) with impacted mandibular third molars participated in the study', '60 patients', 'partially impacted mandibular third molar surgery']","['CGF', 'concentrated growth factor(CGF', 'concentrated growth factor (CGF']","['healing of soft tissue around the extraction socket', 'pain, swelling and trismus', 'soft tissue healing and postoperative side effects', 'soft tissue healing, postoperative pain, swelling, and trismus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",60.0,0.163549,"Statistical analysis revealed that there were significant differences between the control and test groups with regard to soft tissue healing, postoperative pain, swelling, and trismus (P<0.001).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Özveri Koyuncu', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: banuozverikoyuncu@yahoo.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Işık', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: gozdech@hotmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Özden Yüce', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: meltemozdn@hotmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Günbay', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: sevtapgunbay@gmail.com.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Günbay', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: tgunbay@gmail.com.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.07.002']
274,32273271,A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.,"OBJECTIVE


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


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


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


Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.",2020,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","['type 2 diabetes (T2D', 'Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial', '176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c  9.5 ± 2.2%), treated with oral agents or insulin before admission', 'noncritically ill patients with T2D.\nMETHODS']","['Glargine U300 and Glargine U100', 'U300 glargine insulin', 'glargine U300 versus glargine', 'glargine U100', 'glargine U300']","['percentage of readings within target BG', 'safety and efficacy', 'rates of clinically significant hypoglycemia', 'length of stay', 'hospital complications', 'occurrence of hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",176.0,0.187812,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Lansang', 'Affiliation': 'The Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Khowaja', 'Affiliation': 'Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'M Agustina', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Migdal', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA geumpie@emory.edu.'}]",Diabetes care,['10.2337/dc19-1940']
275,31101538,Clinically Meaningful Change in Sexual Desire in the Psychosexual Daily Questionnaire in Older Men from the TTrials.,"BACKGROUND


A recent study of older men participating in the Testosterone Trials (TTrials) defined a clinically meaningful change in the Psychosexual Daily Questionnaire (PDQ) question 4 in hypogonadal men age ≥65 years. This study defines clinically meaningful change in the same population for sexual desire assessed by PDQ question 1.
AIM


To determine a clinically meaningful change in the answers to question 1 of the PDQ in hypogonadal older men.
METHODS


Participants in the Sexual Function Trial of the TTrials were randomly divided into a training and test set. Anchor-based methods, including regression analysis, receiver operating characteristic curves, and empirical cumulative distribution functions, were used to determine a clinically meaningful change on question 1 in the training set, and the selected threshold was evaluated in the test set for an effect of testosterone treatment.
RESULTS


A clinically meaningful increase in question 1 of the PDQ was determined to be ≥0.7 points.
CLINICAL IMPLICATIONS


Question 1 of the PDQ can be used to assess sexual desire in response to testosterone treatment.
STRENGTHS & LIMITATIONS


Data were obtained from a single large study of older hypogonadal men.
CONCLUSION


Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ. Stephens-Shields AJ, Wang C, Preston P, et al. Clinically Meaningful Change in Sexual Desire in the Psychosexual Daily Questionnaire in Older Men from the TTrials. J Sex Med 2019;16:951-953.",2019,Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ.,"['hypogonadal older men', 'older hypogonadal men', 'Participants in the Sexual Function Trial of the TTrials', 'older men participating in the Testosterone Trials (TTrials) defined a clinically meaningful change in the Psychosexual Daily Questionnaire (PDQ) question 4 in hypogonadal men age ≥65 years', 'Older Men from the TTrials']",[],"['Sexual Desire', 'sexual desire']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}]",,0.0448764,Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ.,"[{'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: alisaste@pennmedicine.upenn.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.04.003']
276,32108304,Effects of ePREP and OurRelationship on Low-Income Couples' Mental Health and Health Behaviors: a Randomized Controlled Trial.,"Relationship distress is a pervasive problem in the USA that disproportionally impacts couples with low-income levels. The goal of the present study was to evaluate the effectiveness of two online relationship interventions, OurRelationship and ePREP, both of which were supported by a paraprofessional coach, in improving mental health and physical health behaviors with low-income couples. Couples (N = 742) were randomized to either intervention or a 6-month waitlist control group and assessed pre-, mid-, and post-intervention as well at 4 and 6 months after randomization. Results from multilevel models indicated that during treatment, compared to couples in the waitlist group, couples in the intervention groups reported significantly greater improvements in mental health that were small to moderate in magnitude (psychological distress, anger, problematic alcohol use, and perceived stress) as well as improvements in physical health/health behaviors (perceived health, insomnia, and exercise) that were small in magnitude. Furthermore, the differences between intervention and waitlist groups were maintained over follow-up. Treatment gains in both mental health and physical health behaviors were generally stronger for those who began treatment with greater difficulties in those areas. Implications of these findings with regard to intervention and policy are discussed.",2020,"Results from multilevel models indicated that during treatment, compared to couples in the waitlist group, couples in the intervention groups reported significantly greater improvements in mental health that were small to moderate in magnitude (psychological distress, anger, problematic alcohol use, and perceived stress) as well as improvements in physical health/health behaviors (perceived health, insomnia, and exercise) that were small in magnitude.",['Couples (N\u2009=\u2009742'],"['intervention or a 6-month waitlist control group and assessed pre-, mid-, and post-intervention', 'ePREP and OurRelationship']","['physical health/health behaviors (perceived health, insomnia, and exercise', 'magnitude (psychological distress, anger, problematic alcohol use, and perceived stress', 'mental health and physical health behaviors', ""Low-Income Couples' Mental Health and Health Behaviors"", 'mental health']","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018687'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",742.0,0.0499119,"Results from multilevel models indicated that during treatment, compared to couples in the waitlist group, couples in the intervention groups reported significantly greater improvements in mental health that were small to moderate in magnitude (psychological distress, anger, problematic alcohol use, and perceived stress) as well as improvements in physical health/health behaviors (perceived health, insomnia, and exercise) that were small in magnitude.","[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Department of Psychology, Univeristy of Miami, Coral Gables, FL, USA. mkr19@miami.edu.'}, {'ForeName': 'Galena K', 'Initials': 'GK', 'LastName': 'Rhoades', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Doss', 'Affiliation': 'Department of Psychology, Univeristy of Miami, Coral Gables, FL, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01100-y']
277,32287316,Ototopical drops containing a novel antibacterial synthetic peptide: Safety and efficacy in adults with chronic suppurative otitis media.,"OBJECTIVE


Chronic suppurative otitis media (CSOM) is a chronic infectious disease with worldwide prevalence that causes hearing loss and decreased quality of life. As current (antibiotic) treatments often unsuccessful and antibiotic resistance is emerging, alternative agents and/or strategies are urgently needed. We considered the synthetic antimicrobial and anti-biofilm peptide P60.4Ac to be an interesting candidate because it also displays anti-inflammatory activities including lipopolysaccharide-neutralizing activity. The aim of the present study was to investigate the safety and efficacy of ototopical drops containing P60.4Ac in adults with CSOM without cholesteatoma.
METHODS


We conducted a range-finding study in 16 subjects followed by a randomized, double blinded, placebo-controlled, multicentre phase IIa study in 34 subjects. P60.4Ac-containing ototopical drops or placebo drops were applied twice a day for 2 weeks and adverse events (AEs) and medication use were recorded. Laboratory tests, swabs from the middle ear and throat for bacterial cultures, and audiometry were performed at intervals up to 10 weeks after therapy. Response to treatment was assessed by blinded symptom scoring on otoscopy.
RESULTS


Application of P60.4Ac-containing ototopical drops (0.25-2.0 mg of peptide/ml) in the ear canal of patients suffering from CSOM was found to be safe and well-tolerated. The optimal dose (0.5 mg of peptide/ml) was selected for the subsequent phase IIa study. Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity. In addition to this excellent safety profile, P60.4Ac ototopical drops resulted in a treatment success in 47% of cases versus 6% in the placebo group.
CONCLUSION


The efficacy/safety balance assessed in the present study provides a compelling justification for continued clinical development of P60.4Ac in therapy-resistant CSOM.",2020,"Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity.","['Chronic suppurative otitis media (CSOM', '16 subjects', 'controlled, multicentre phase IIa study in 34 subjects', 'adults with CSOM without cholesteatoma', 'adults with chronic suppurative otitis media']","['ototopical drops containing P60.4Ac', 'P60.4Ac-containing ototopical drops or placebo', 'placebo', 'Ototopical drops containing a novel antibacterial synthetic peptide']","['safety and efficacy', 'safe and well-tolerated', 'efficacy/safety balance']","[{'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",16.0,0.265936,"Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity.","[{'ForeName': 'Nanno F A W', 'Initials': 'NFAW', 'LastName': 'Peek', 'Affiliation': 'Department of Ear Nose and Throat, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Marja J', 'Initials': 'MJ', 'LastName': 'Nell', 'Affiliation': ""Octoplus Technologies BV/Dr Reddy's research and development BV, Leiden, The Netherlands.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Brand', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'Jansen-Werkhoven', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Ewoud J', 'Initials': 'EJ', 'LastName': 'van Hoogdalem', 'Affiliation': ""Octoplus Technologies BV/Dr Reddy's research and development BV, Leiden, The Netherlands.""}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Verrijk', 'Affiliation': ""Octoplus Technologies BV/Dr Reddy's research and development BV, Leiden, The Netherlands.""}, {'ForeName': 'Marcel J', 'Initials': 'MJ', 'LastName': 'Vonk', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Amon R', 'Initials': 'AR', 'LastName': 'Wafelman', 'Affiliation': 'Clinical Pharmacology and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'A Rob P M', 'Initials': 'ARPM', 'LastName': 'Valentijn', 'Affiliation': 'Clinical Pharmacology and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Johan H M', 'Initials': 'JHM', 'LastName': 'Frijns', 'Affiliation': 'Department of Ear Nose and Throat, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Pieter S', 'Initials': 'PS', 'LastName': 'Hiemstra', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Drijfhout', 'Affiliation': 'Immunohematology and Blood Transfusion, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Nibbering', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Grote', 'Affiliation': 'Department of Ear Nose and Throat, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0231573']
278,30962245,Tailored digital behaviour change intervention with e-referral system to increase attendance at NHS stop smoking services (the MyWay project): study protocol for a randomised controlled feasibility trial.,"INTRODUCTION


In the UK, smokers who use stop smoking services (SSSs) are four times more likely to stop smoking than smokers who do not. Attendance has declined, warranting the development of interventions to address this. StopApp is a novel, brief online behaviour change intervention designed to address common barriers to SSS attendance. It links to widely commissioned service management software that enables instant appointment booking at a user's location and time of choice.
METHODS AND ANALYSIS


A two-arm parallel group, individual participant feasibility randomised controlled trial of StopApp (intervention) compared with the standard promotion of and referral to SSSs (control). The study includes a nested qualitative process evaluation to assess the acceptability of the research processes, with a subsample of participants. Smokers aged over 16 years will be recruited via three routes: General Practice (GP), community settings and online. After consenting and the collection of baseline data, participants will be randomised to control or intervention groups. Participants in the intervention group receive a link to StopApp and those in the control group receive standard web-based information about the SSSs. All participants are told they can book a SSS appointment but are under no obligation to do so. Online follow-up 2 months post randomisation includes data on SSS use and carbon monoxide verified 4-week quit rates. The study aims to recruit 162 smokers.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the West Midlands-Edgbaston NHS Research Ethics Committee. The findings will be reported in conferences and peer-reviewed publications; and will be used to design the parameters necessary for a definitive trial to ascertain the effectiveness of StopApp at increasing booking and attendance at SSSs compared with existing methods for encouraging uptake.",2019,Participants in the intervention group receive a link to StopApp and those in the control group receive standard web-based information about the SSSs.,"['162 smokers', 'Smokers aged over 16 years']","['StopApp (intervention', 'standard promotion of and referral to SSSs (control', 'NHS', 'link to StopApp and those in the control group receive standard web-based information about the SSSs']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0809087,Participants in the intervention group receive a link to StopApp and those in the control group receive standard web-based information about the SSSs.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fulton', 'Affiliation': 'Centre for Advances in Behavioural Science, Coventry University, Coventry, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Newby', 'Affiliation': 'Centre for Advances in Behavioural Science, Coventry University, Coventry, UK.'}, {'ForeName': 'Kajal', 'Initials': 'K', 'LastName': 'Gokal', 'Affiliation': 'Centre for Advances in Behavioural Science, Coventry University, Coventry, UK.'}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Kwah', 'Affiliation': 'Centre for Advances in Behavioural Science, Coventry University, Coventry, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Schumacher', 'Affiliation': 'Centre for Advances in Behavioural Science, Coventry University, Coventry, UK.'}, {'ForeName': 'Louise J', 'Initials': 'LJ', 'LastName': 'Jackson', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'School of Health Sciences, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Coleman', 'Affiliation': 'Division of General Practice, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Centre for Advances in Behavioural Science, Coventry University, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028721']
279,32282852,"Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data.","OBJECTIVES


To assess the effects of early management of hyperglycaemia with antidiabetic drugs plus lifestyle intervention compared with lifestyle alone, on microvascular function in adults with pre-diabetes.
METHODS


Trial design: International, multicenter, randomised, partially double-blind, placebo-controlled, clinical trial.
PARTICIPANTS


Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey.
INTERVENTION


Participants were randomized to placebo; metformin 1.700 mg/day; linagliptin 5 mg/day or fixed-dose combination of linagliptin/metformin. All patients were enrolled in a lifestyle intervention program (diet and physical activity). Drug intervention will last 2 years. Primary Outcome: composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index. Secondary outcomes in a subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function.
RESULTS


One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin. A total of 809 people (91.1%) accepted and initiated the assigned treatment. Study sample after randomization was well balanced among the four groups. No statistical differences for the main risk factors analysed were observed between those accepting or rejecting treatment initiation. At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%.
CONCLUSIONS


ePREDICE is the first -randomized clinical trial with the aim to assess effects of different interventions (lifestyle and pharmacological) on microvascular function in people with pre-diabetes. The trial will provide novel data on lifestyle modification combined with glucose lowering drugs for the prevention of early microvascular complications and diabetes.
REGISTRATION


- ClinicalTrials.Gov Identifier: NCT03222765 - EUDRACT Registry Number: 2013-000418-39.",2020,"At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%.
","['people with pre-diabetes', 'One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to', 'Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey', '809 people (91.1%) accepted and initiated the assigned treatment', 'people with hyperglycaemia in Europe', 'adults with pre-diabetes']","['placebo; metformin', 'placebo', 'hyperglycaemia with antidiabetic drugs plus lifestyle intervention', 'interventions (lifestyle and pharmacological', 'glucose lowering drugs', 'linagliptin/metformin', 'linagliptin', 'lifestyle intervention program (diet and physical activity', 'placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin']","['microvascular function', 'subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function', 'diabetic retinopathy', 'composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0036708', 'cui_str': 'Republic of Serbia'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3264599', 'cui_str': 'metformin and linagliptin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",1391.0,0.37646,"At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%.
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gabriel', 'Affiliation': 'Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Boukichou Abdelkader', 'Affiliation': 'EVIDEM CONSULTORES, Madrid, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Acosta', 'Affiliation': 'EVIDEM CONSULTORES, Madrid, Spain.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Gilis-Januszewska', 'Affiliation': 'Uniwersytet Jagiellonski, Collegium Medicum, Krakow, Poland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gómez-Huelgas', 'Affiliation': 'Fundación FIMABIS. Servicio Andaluz de Salud (SAS), Malaga, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Zdravko', 'Initials': 'Z', 'LastName': 'Kamenov', 'Affiliation': 'University Multi-Profile Hospital for Active Treatment Alexandrovska EAD, Sofia, Bulgaria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Paulweber', 'Affiliation': 'Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft, (SALK) Salzburg, Austria.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Satman', 'Affiliation': 'Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Djordjevic', 'Affiliation': 'General Hospital Medical System Beograd-MSB Belgrade Serbia, Beograd, Serbia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Dasman Diabetes Research Institute, Kuwait, Kuwait.'}, {'ForeName': 'Asimina', 'Initials': 'A', 'LastName': 'Mitrakou', 'Affiliation': 'Alexandra Hospital, University of Athens, Athens, Greece.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Lalic', 'Affiliation': 'Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Colagiuri', 'Affiliation': 'The University of Sydney, Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Sydney, Australia.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Egido', 'Affiliation': 'Renal, Vascular and Diabetes Research Laboratory, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Universidad Autónoma, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natali', 'Affiliation': 'Department of Internal Medicine, Universita di Pisa, Pisa, Italy.'}, {'ForeName': 'J Carlos', 'Initials': 'JC', 'LastName': 'Pastor', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Teuschl', 'Affiliation': 'Department for Clinical Neurosciences and Preventive Medicine, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Västra Götalands Läns Landsting, Gothenburg, Sweden.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Silva', 'Affiliation': 'EVIDEM CONSULTORES, Madrid, Spain.'}, {'ForeName': 'Ruy', 'Initials': 'R', 'LastName': 'López-Ridaura', 'Affiliation': 'Instituto Nacional de Salud Púbica, Cuernavaca, México.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0231196']
280,32304001,Evaluation of adjunctive efficacy of diode laser in the treatment of peri-implant mucositis: a randomized clinical trial.,"Peri-implant disease may affect survival of dental implants. The aim of the study is to analyze the effectiveness of diode laser as a supportive modality to the non-surgical conventional treatment of peri-implant mucositis (PiM) and initial peri-implantitis (PI). Twenty-three patients with single implants suffering from PiM or initial PI were selected and randomly divided into two groups; control group (CG) received non-surgical conventional treatment, and test group (TG) received non-surgical conventional treatment and diode laser application with wavelength of 980 nm. Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1). The average of PPD value for TG was 4.04 ± 0.54 mm at T0 and it was 2.98 ± 0.70 mm at T1. In the CG, PPD average was 3.8 ± 1.24 mm at T0 and was 3.54 ± 0.35 mm at T1. In TG, the BOP was positive in 44 sites at T0 and in 6 sites at T1. In CG, the BOP was positively observed in 52 sites at T0 and in 28 sites at T1. The 980-nm diode laser may be considered an adjunct to the conventional non-surgical treatments of PiM and initial PI.",2020,Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1).,"['peri-implant mucositis (PiM) and initial peri-implantitis (PI', 'peri-implant mucositis', 'Twenty-three patients with single implants suffering from PiM or initial PI']","['diode laser', 'control group (CG) received non-surgical conventional treatment, and test group (TG) received non-surgical conventional treatment and diode laser application with wavelength of 980\xa0nm']","['average of PPD value for TG', 'BOP', 'Probing pocket depth (PPD) and bleeding on probing (BOP']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",23.0,0.0224006,Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1).,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tenore', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Montori', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mohsen', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy. ahmed.mohsen@uniroma1.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mattarelli', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Gaspare', 'Initials': 'G', 'LastName': 'Palaia', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Romeo', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}]",Lasers in medical science,['10.1007/s10103-020-03009-y']
281,32307515,"A multicentre, pragmatic, cluster randomised, controlled feasibility trial of the POD system of care.","OBJECTIVE


to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial.
DESIGN


cluster randomised and controlled feasibility trial.
SETTING


sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales.
PARTICIPANTS


patients 65 years and over admitted to participating wards during the trial period.
INTERVENTIONS


participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent.
RESULTS


out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37-1.26); P = 0.2225).
CONCLUSIONS


based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.",2020,"Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37-1.26); P = 0.2225).
","['sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales', 'patients 65\xa0years and over admitted to participating wards during the trial period', '5220 patients in 26 two-ward hospital clusters', 'out of 4449', '714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew', '3274 patients admitted to the wards were eligible']","['delirium (POD) system of care', 'POD programme or usual care, determined by existing local policies and practices']","['Rates of new-onset delirium', 'incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10\xa0days post consent']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",33.0,0.217047,"Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37-1.26); P = 0.2225).
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Teale', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Siddiqi', 'Affiliation': 'Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]",Age and ageing,['10.1093/ageing/afaa044']
282,31326593,Ropivacaine versus placebo on postoperative analgesia and chronic pain following third molar extraction: A Prospective Randomized Controlled Study.,"PURPOSE


The present study aimed at assessing the efficiency of ropivacaine on post-operative pain for extraction of third molars.
METHODS


In a single centre, prospective, parallel, double blind randomised trial, patients scheduled for removal of all four third molars, ASA I-III patients<65 year-old patients were included. After intubation under general anesthesia (using intravenous remifentanil and propofol), for each of the third molars, 2mL of ropivacaine (7.5mg/mL) or placebo (0.9% saline solution) was injected into the vestibular capsule (total: 8mL) before extraction. At the end of surgery, similar analgesia was injected for both groups (intravenous paracetamol 1g and ketoprofene 100mg). The primary outcome was postoperative pain assessed by Visual Analog Scale (VAS). Postoperative consumption of analgesics (morphine titration in post-operative care unit when VAS>3/10, followed by oral tramadol 50mg after discharge), patient satisfaction, chronic pain (1-3 month), time in PACU and total hospitalization time were also recorded.
RESULTS


A total of 50 patients were analysed in each group with similar characteristics (ropivacaine vs. control, for age (years) 18 [17-21] vs. 18 [17-21], for sex (female) 33 (66%) vs. 25 (50%), and BMI (kg/m 2 ): 20 [19-23] vs. 21 [19-23]). Area Under the Curve for VAS pain (0 to 4h) was lower for Ropivacaine group: 0.43 [0.19-0.66] vs. 0.63 [0.43-0.87], P=0.005. Use of morphine in PACU (8 vs. 18, P=0.02) and median length of stay in ambulatory setting (5 vs. 6h, P=0.03) were reduced in Ropivacaine vs. Placebo group. At days 1 and 4, VAS of pain was higher in Ropivacaine group (respectively 4 vs. 2, P=0.006 and 3 vs. 2, P=0.05). At month 1 and 3, pain and DN4 score were similar between groups, with a median VAS pain score at 0 for both groups (P=0.42). No difference was observed for patient satisfaction and adverse events.
CONCLUSIONS


Ropivacaine provides an immediate efficient pain relief after extraction of third molars without benefit after discharge.
CLINICALTRIAL REGISTRATION


NCT01541059.",2020,"At days 1 and 4, VAS of pain was higher in Ropivacaine group (respectively 4 vs. 2, P=0.006 and 3 vs. 2, P=0.05).","['patients scheduled for removal of all four third molars, ASA I-III', 'patients<65 year-old patients were included', 'A total of 50 patients were analysed in each group with similar characteristics (ropivacaine vs. control, for age (years) 18 [17-21] vs. 18 [17-21], for sex (female) 33 (66%) vs. 25 (50%), and BMI (kg/m 2 ): 20 [19-23] vs. 21 [19-23', 'following third molar extraction']","['Ropivacaine', 'remifentanil and propofol', 'Ropivacaine vs. Placebo', 'placebo', 'ropivacaine', 'morphine', 'analgesics (morphine titration']","['median VAS pain score', 'postoperative pain assessed by Visual Analog Scale (VAS', 'patient satisfaction and adverse events', 'time in PACU and total hospitalization time', 'patient satisfaction, chronic pain', 'postoperative analgesia and chronic pain', 'VAS of pain', 'pain and DN4 score', 'VAS pain', 'median length of stay in ambulatory setting']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]",,0.691117,"At days 1 and 4, VAS of pain was higher in Ropivacaine group (respectively 4 vs. 2, P=0.006 and 3 vs. 2, P=0.05).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ghezal', 'Affiliation': 'Department of Anaesthesia, Pain and Intensive Care Medicine, Univ. Montpellier 1, CHU de Nîmes, place du Professeur Debré, 30029 Nîmes cedex 09, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bouvet', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), Univ. Montpellier, CHU de Nîmes, Nîmes, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kabani', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), Univ. Montpellier, CHU de Nîmes, Nîmes, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ripart', 'Affiliation': 'Department of Anaesthesia, Pain and Intensive Care Medicine, Univ. Montpellier 1, CHU de Nîmes, place du Professeur Debré, 30029 Nîmes cedex 09, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': 'Department of Anaesthesia, Pain and Intensive Care Medicine, Univ. Montpellier 1, CHU de Nîmes, place du Professeur Debré, 30029 Nîmes cedex 09, France. Electronic address: philippe.cuvillon@chu-nimes.fr.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.07.005']
283,32299763,"Modulation of self-appraisal of illness, medication adherence, life quality and autonomic functioning by transcranial direct current stimulation in schizophrenia patients.","OBJECTIVES


Little is known about the impact of fronto-temporal transcranial direct current stimulation (tDCS) on attitudes toward mental illness, psychosocial and autonomic functioning, life quality, and medication adherence among schizophrenia patients.
METHODS


Sixty schizophrenia patients were randomly allocated to receive 10 sessions of active (2 mA, 20 min, 2 sessions/day for five weekdays) or sham fronto-temporal tDCS. Self-Appraisal of Illness Questionnaire (SAIQ), Medication Adherence Rating Scale (MARS), World Health Organization Quality of Life-BREF (WHOQOL-BREF) and indices of heart rate variability (HRV) were measured at baseline, immediately after tDCS and at one-month follow-up visit.
RESULTS


There were significant group-by-time interactions for scores of SAIQ presence/outcome subscale, total MARS and its subscale of subjective response to taking medication, WHOQOL-BREF psychological domain. Relative to sham, tDCS significantly improved self-awareness of presence/outcome of schizophrenia (Cohen's d = 0.465, p = 0.0011), subjective response to taking medication (Cohen's d = 0.639, p < 0.001) and psychological domain of life quality (Cohen's d = 0.459, p = 0.00114). These effects lasted for less than one month. The group-by-time interactions were non-significant for clinician-rated psychosocial functioning, mean RR intervals, and all HRV indices.
CONCLUSION


Fronto-temporal tDCS briefly optimizes self-reported insight levels, beliefs about treatment adherence, and psychological domain of life quality in patients with schizophrenia. Further studies are required to confirm whether patients treated with 5-day, 10-session tDCS in combination with multisession ""maintenance"" stimulation every month would attain favourable outcomes.
SIGNIFICANCE


We provide novel evidence for the potential utility of tDCS in schizophrenia.",2020,"There were significant group-by-time interactions for scores of SAIQ presence/outcome subscale, total MARS and its subscale of subjective response to taking medication, WHOQOL-BREF psychological domain.","['schizophrenia patients', 'patients with schizophrenia', 'Sixty schizophrenia patients']","['fronto-temporal transcranial direct current stimulation (tDCS', '10 sessions of active (2\xa0mA, 20\xa0min, 2 sessions/day for five weekdays) or sham fronto-temporal tDCS']","['Modulation of self-appraisal of illness, medication adherence, life quality and autonomic functioning', 'attitudes toward mental illness, psychosocial and autonomic functioning, life quality, and medication adherence', 'psychological domain of life quality', 'clinician-rated psychosocial functioning, mean RR intervals, and all HRV indices', 'Self-Appraisal of Illness Questionnaire (SAIQ), Medication Adherence Rating Scale (MARS), World Health Organization Quality of Life-BREF (WHOQOL-BREF) and indices of heart rate variability (HRV', 'subjective response to taking medication', 'self-awareness of presence/outcome of schizophrenia', 'scores of SAIQ presence/outcome subscale, total MARS and its subscale of subjective response to taking medication, WHOQOL-BREF psychological domain']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C2936632', 'cui_str': 'Self-Appraisal'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",60.0,0.0332568,"There were significant group-by-time interactions for scores of SAIQ presence/outcome subscale, total MARS and its subscale of subjective response to taking medication, WHOQOL-BREF psychological domain.","[{'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Kao', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Psychiatry, Tri-Service General Hospital Songshan Branch, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Che-Yi', 'Initials': 'CY', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Cardinal Tien Hospital, New Taipei, Taiwan.'}, {'ForeName': 'Chuan-Chia', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Electronic address: changcc@mail.ndmctsgh.edu.tw.'}, {'ForeName': 'Hsin-An', 'Initials': 'HA', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Electronic address: chang.ha@mail.ndmctsgh.edu.tw.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.02.029']
284,32299792,Teaching the National Institutes of Health Stroke Scale to Paramedics (E-Learning vs Video): Randomized Controlled Trial.,"BACKGROUND


Prompt and accurate identification of stroke victims is essential to reduce time from symptom onset to adequate treatment and to improve neurological outcomes. Most neurologists evaluate the extent of neurological deficit according to the National Institutes of Health Stroke Scale (NIHSS), but the use of this scale by paramedics, the first healthcare providers to usually take care of stroke victims, has proven unreliable. This might be, at least in part, due to the teaching method. The video used to teach NIHSS lacks interactivity, while more engaging electronic learning (e-learning) methods might improve knowledge acquisition.
OBJECTIVE


This study was designed to evaluate whether a highly interactive e-learning module could enhance NIHSS knowledge acquisition in paramedics.
METHODS


A randomized controlled trial comparing a specially designed e-learning module with the original NIHSS video was performed with paramedics working in Geneva, Switzerland. A registration number was not required as our study does not come into the scope of the Swiss federal law on human research. The protocol was nevertheless submitted to the local ethics committee (Project ID 2017-00847), which issued a ""Declaration of no objection."" Paramedics were excluded if they had prior knowledge of or previous training in the NIHSS, or if they had worked in a neurology or neurosurgery ward. The primary outcome was overall performance in the study quiz, which contained 50 questions. Secondary outcomes were performance by NIHSS item, time to course and quiz completion, user satisfaction regarding the learning method, user perception of the course duration, and probability the user would recommend the course to a colleague.
RESULTS


The study was completed by 39 paramedics. There was a better overall median score (36/50 vs 33/50, P=.04) and a higher degree of satisfaction regarding the learning method in the e-learning group (90% vs 37%, P=.002). Users who had followed the e-learning module were more likely to recommend the course to a colleague (95% vs 63%, P=.02). Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01). Time to quiz completion was similar between groups (25 vs 38 minutes, P=.12).
CONCLUSIONS


Use of an e-learning module shows promising results in teaching the NIHSS to paramedics.",2020,"Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01).","['paramedics', 'Paramedics were excluded if they had prior knowledge of or previous training in the NIHSS, or if they had worked in a neurology or neurosurgery ward', 'paramedics working in Geneva, Switzerland']",['highly interactive e-learning module'],"['overall median score', 'overall performance', 'Time to quiz completion', ""performance by NIHSS item, time to course and to quiz completion, user satisfaction regarding the learning method, user's perception of the course duration, and probability the user would recommend the course to a colleague""]","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0832196,"Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01).","[{'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Koka', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottet', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Carrera', 'Affiliation': 'Stroke Center, Department of Neurology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Geneva, Switzerland.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Suppan', 'Affiliation': 'Division of Anesthesiology, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}]",Journal of medical Internet research,['10.2196/18358']
285,31591826,"Beneficial effects of ivabradine in patients with heart failure, low ejection fraction, and heart rate above 77 b.p.m.","AIMS


Ivabradine has been approved in heart failure with reduced ejection fraction (HFrEF) and elevated heart rate despite guideline-directed medical therapy (GDMT) to reduce cardiovascular (CV) death and hospitalization for worsening HF. The median value of 77 b.p.m. is the lower bound selected for the regulatory approval in Canada, South Africa, and Australia. Patient-reported outcomes (PROs) including symptoms, quality of life, and global assessment are considered of major interest in the global plan of care of patients with HF. However, the specific impact of GDMT, and specifically ivabradine, on PRO remains poorly studied. In the subgroup of patients from the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT) who had heart rate above the median of 77 b.p.m. (pre-specified analysis) and for whom the potential for improvement was expected to be larger, we aimed (i) to evaluate the effects of ivabradine on PRO (symptoms, quality of life, and global assessment); (ii) to consolidate the effects of ivabradine on the primary composite endpoint of CV death and hospitalization for HF; and (iii) to reassess the effects of ivabradine on left ventricular (LV) remodelling.
METHODS AND RESULTS


Comparisons were made according to therapy, and proportional hazards models (adjusted for baseline beta-blocker therapy) were used to estimate the association between ivabradine and various outcomes. In SHIFT, n = 3357 (51.6%) patients had a baseline heart rate > 77 b.p.m. After a median follow-up of 22.9 months (inter-quartile range 18-28 months), ivabradine on top of GDMT improved symptoms (28% vs. 23% improvement in New York Heart Association functional class, P = 0.0003), quality of life (5.3 vs. 2.2 improvement in Kansas City Cardiomyopathy Questionnaire overall summary score, P = 0.005), and global assessment [from both patient (improved in 72.3%) and physician (improved in 61.0%) perspectives] significantly more than did placebo (both P < 0.0001). Ivabradine induced a 25% reduction in the combined endpoint of CV death and hospitalization for HF (hazard ratio 0.75; P < 0.0001), which translates into a number of patients needed to be treated for 1 year of 17. Patients under ivabradine treatment demonstrated a significant reduction in LV dimensions when reassessed at 8 months (P < 0.05).
CONCLUSIONS


In patients with chronic HFrEF, sinus rhythm, and a heart rate > 77 b.p.m. while on GDMT, the present analysis brings novel insights into the role of ivabradine in improving the management of HFrEF, particularly with regard to PRO (ISRCTN70429960).",2019,"Patients under ivabradine treatment demonstrated a significant reduction in LV dimensions when reassessed at 8 months (P < 0.05).
","['patients with heart failure, low ejection fraction, and heart rate above 77 b.p.m', 'patients with chronic HFrEF, sinus rhythm, and a heart rate > 77 b.p.m']","['placebo', 'ivabradine', 'Ivabradine']","['PRO (symptoms, quality of life, and global assessment', 'quality of life', 'left ventricular (LV) remodelling', 'symptoms, quality of life, and global assessment are considered of major interest in the global plan of care of patients with HF', 'CV death and hospitalization for HF', 'LV dimensions', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0588873,"Patients under ivabradine treatment demonstrated a significant reduction in LV dimensions when reassessed at 8 months (P < 0.05).
","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bouabdallaoui', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, 5000 Belanger Street, Montreal, H1T 1C8, Quebec, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute, Université de Montréal, 5000 Belanger Street, Montreal, H1T 1C8, Quebec, Canada.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Bernier', 'Affiliation': 'Scientific and Medical Affairs, Servier Canada Inc., Laval, Quebec, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Department of Cardiology, Paris Saint Joseph Hospital, Paris, France.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Tavazzi', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Borer', 'Affiliation': 'Howard Gilman and Schiavone Institutes, State University of New York Downstate Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bohm', 'Affiliation': 'Internal Medicine Clinic III, Saarland University Clinic, Saarland University, Homburg, Saar, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, 5000 Belanger Street, Montreal, H1T 1C8, Quebec, Canada.'}]",ESC heart failure,['10.1002/ehf2.12513']
286,30827132,Detection of Left Ventricular Hypertrophy Using Bayesian Additive Regression Trees: The MESA.,"Background We developed a new left ventricular hypertrophy ( LVH ) criterion using a machine-learning technique called Bayesian Additive Regression Trees ( BART ). Methods and Results This analysis included 4714 participants from MESA (Multi-Ethnic Study of Atherosclerosis) free of clinically apparent cardiovascular disease at enrollment. We used BART to predict LV mass from ECG and participant characteristics using cardiac magnetic resonance imaging as the standard. Participants were randomly divided into a training set (n=3774) and a validation set (n=940). We compared the diagnostic/prognostic performance of our new BART - LVH criteria with traditional ECG - LVH criteria and cardiac magnetic resonance imaging- LVH . In the validation set, BART - LVH showed the highest sensitivity (29.0%; 95% CI , 18.3%-39.7%), followed by Sokolow-Lyon- LVH (21.7%; 95% CI , 12.0%-31.5%), Peguero-Lo Presti (14.5%; 95% CI , 6.2%-22.8%), Cornell voltage product (10.1%; 95% CI , 3.0%-17.3%), and Cornell voltage (5.8%; 95% CI , 0.3%-11.3%). The specificity was >93% for all criteria. During a median follow-up of 12.3 years, 591 deaths, 492 cardiovascular disease events, and 332 coronary heart disease events were observed. In adjusted Cox models, both BART - LVH and cardiac magnetic resonance imaging- LVH were associated with mortality (hazard ratio [95% CI ], 1.88 [1.45-2.44] and 2.21 [1.74-2.81], respectively), cardiovascular disease events (hazard ratio [95% CI ], 1.46 [1.08-1.98] and 1.91 [1.46-2.51], respectively), and coronary heart disease events (hazard ratio [95% CI ], 1.72 [1.20-2.47] and 1.96 [1.41-2.73], respectively). These associations were stronger than associations observed with traditional ECG - LVH criteria. Conclusions Our new BART - LVH criteria have superior diagnostic/prognostic ability to traditional ECG - LVH criteria and similar performance to cardiac magnetic resonance imaging- LVH for predicting events.",2019,Our new BART - LVH criteria have superior diagnostic/prognostic ability to traditional ECG - LVH criteria and similar performance to cardiac magnetic resonance imaging- LVH for predicting events.,['4714 participants from MESA (Multi-Ethnic Study of Atherosclerosis) free of clinically apparent cardiovascular disease at enrollment'],['machine-learning technique called Bayesian Additive Regression Trees ( BART '],"['Cornell voltage product', 'highest sensitivity', 'cardiovascular disease events', 'Peguero-Lo Presti', 'coronary heart disease events', '332 coronary heart disease events', 'Cornell voltage']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0040811', 'cui_str': 'Trees'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]",4714.0,0.139545,Our new BART - LVH criteria have superior diagnostic/prognostic ability to traditional ECG - LVH criteria and similar performance to cardiac magnetic resonance imaging- LVH for predicting events.,"[{'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sparapani', 'Affiliation': '1 Institute for Health and Equity Division of Biostatistics Medical College of Wisconsin Milwaukee WI.'}, {'ForeName': 'Noura M', 'Initials': 'NM', 'LastName': 'Dabbouseh', 'Affiliation': '2 Cardiovascular Center Medical College of Wisconsin Milwaukee WI.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gutterman', 'Affiliation': '2 Cardiovascular Center Medical College of Wisconsin Milwaukee WI.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': '4 Department of Electrical Engineering and Computer Science University of Wisconsin-Milwaukee Milwaukee WI.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': '5 Division of Public Health Sciences Department of Biostatistical Sciences Wake Forest School of Medicine Winston Salem NC.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bluemke', 'Affiliation': '6 Department of Radiology School of Medicine and Public Health University of Wisconsin Madison WI.'}, {'ForeName': 'Joao A C', 'Initials': 'JAC', 'LastName': 'Lima', 'Affiliation': '7 Division of Cardiology and Department of Radiology Department of Medicine Johns Hopkins University Baltimore MD.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Burke', 'Affiliation': '8 Division of Public Health Sciences Wake Forest School of Medicine Winston Salem NC.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': '9 Epidemiological Cardiology Research Center Department of Epidemiology and Prevention Wake Forest School of Medicine Winston Salem NC.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.009959']
287,31568696,Hepatorenal dysfunction identifies high-risk patients with acute heart failure: insights from the RELAX-AHF trial.,"AIMS


Episodes of acute heart failure (AHF) may lead to end-organ dysfunction. In this post hoc analysis of the Relaxin in Acute Heart Failure trial, we used the MELD-XI (Model of End-Stage Liver Dysfunction) score to examine hepatorenal dysfunction in patients with AHF.
METHODS AND RESULTS


On admission, the MELD-XI score was elevated (abnormal) in 918 (82%) patients, with 638 (57%) having isolated renal dysfunction (creatinine > 1 mg/dL), 73 (6.5%) isolated liver dysfunction (bilirubin > 1 mg/dL), and 207 (18.5%) coexisting dysfunction of the kidneys and the liver (both creatinine and bilirubin > 1 mg/dL). The percentage of patients with elevated MELD-XI score remained constant through a 60 day follow-up, as we observed a gradual decrease of liver dysfunction prevalence, counterbalanced by an increase in renal dysfunction. Serelaxin treatment was associated with a lower MELD-XI score on Day 2 and Day 5 (both P < 0.05), but this difference vs. placebo disappeared during longer follow-up. In the multivariable model, an elevated MELD-XI score on admission was associated with higher 180 day mortality: hazard ratios (95% confidence interval) for cardiovascular death were 3.10 (1.22-7.87), and for all-cause death 2.47 (1.19-5.15); both P < 0.05. The addition of the MELD-XI score to a prespecified prognostic model increased the discrimination of the model for all-cause death, but the increment in the C-index was only modest: 0.013 (P = 0.02).
CONCLUSIONS


In patients with AHF, hepatorenal dysfunction is prevalent and related to poor outcome. The MELD-XI score is a useful prognosticator in AHF.",2019,"Serelaxin treatment was associated with a lower MELD-XI score on Day 2 and Day 5 (both P < 0.05), but this difference vs. placebo disappeared during longer follow-up.","['patients with AHF', 'risk patients with acute heart failure']","['placebo', 'Serelaxin']","['liver dysfunction prevalence', 'percentage of patients with elevated MELD-XI score', 'MELD-XI score', 'isolated renal dysfunction', 'coexisting dysfunction of the kidneys and the liver (both creatinine and bilirubin', 'elevated MELD-XI score on admission', 'renal dysfunction', 'isolated liver dysfunction (bilirubin', 'lower MELD-XI score', 'cardiovascular death', 'admission, the MELD-XI score', 'Hepatorenal dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3700393'}]","[{'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0457453', 'cui_str': 'On admission (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0712758,"Serelaxin treatment was associated with a lower MELD-XI score on Day 2 and Day 5 (both P < 0.05), but this difference vs. placebo disappeared during longer follow-up.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Biegus', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Biniyam', 'Initials': 'B', 'LastName': 'Demissei', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Douwe', 'Initials': 'D', 'LastName': 'Postmus', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gimpelewicz', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'University of California at San Diego, San Diego, CA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Institute of Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Severin', 'Affiliation': 'Novartis Pharmaceuticals Corporation, New Hanover, NJ, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}]",ESC heart failure,['10.1002/ehf2.12477']
288,31252032,IL-4Rα Blockade by Dupilumab Decreases Staphylococcus aureus Colonization and Increases Microbial Diversity in Atopic Dermatitis.,"Dupilumab is a fully human antibody to interleukin-4 receptor α that improves the signs and symptoms of moderate to severe atopic dermatitis (AD). To determine the effects of dupilumab on Staphylococcus aureus colonization and microbial diversity on the skin, bacterial DNA was analyzed from swabs collected from lesional and nonlesional skin in a double-blind, placebo-controlled study of 54 patients with moderate to severe AD randomized (1:1) and treated with either dupilumab (200 mg weekly) or placebo for 16 weeks. Microbial diversity and relative abundance of Staphylococcus were assessed by DNA sequencing of 16S ribosomal RNA, and absolute S. aureus abundance was measured by quantitative PCR. Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin. During dupilumab treatment, microbial diversity increased and the abundance of S. aureus decreased. Pronounced changes were seen in nonlesional and lesional skin. Decreased S. aureus abundance during dupilumab treatment correlated with clinical improvement of AD and biomarkers of type 2 immunity. We conclude that clinical improvement of AD that is mediated by interleukin-4 receptor α inhibition and the subsequent suppression of type 2 inflammation is correlated with increased microbial diversity and reduced abundance of S. aureus.",2020,"Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin.","['54 patients with moderate-to-severe atopic dermatitis randomized (1:1) and treated with either', 'Atopic Dermatitis']","['dupilumab', 'placebo']","['atopic dermatitis and biomarkers of type 2 immunity', 'microbial diversity', 'Microbial diversity and relative abundance of Staphylococcus', 'nonlesional and lesional skin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",54.0,0.107796,"Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Callewaert', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA; Center for Microbial Ecology and Technology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Teruaki', 'Initials': 'T', 'LastName': 'Nakatsuji', 'Affiliation': 'Department of Dermatology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA; Departments of Computer Science and Engineering, University of California San Diego, La Jolla, California, USA; Center for Microbiome Innovation, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kosciolek', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Vrbanac', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kotol', 'Affiliation': 'Department of Dermatology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi-Genzyme, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Inc., Montreal, Quebec, Canada.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Departments of Dermatology, Preventive Medicine, and Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Department of Dermatology, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Gallo', 'Affiliation': 'Department of Dermatology, University of California San Diego, La Jolla, California, USA. Electronic address: rgallo@ucsd.edu.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.05.024']
289,32299254,Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study.,"Objective:  This study aimed to compare efficacy and safety of lidocaine versus tramadol versus placebo in reducing the pain of diagnostic outpatient hysteroscopy (OH) in postmenopausal women. Materials and methods:  This randomized double-blinded study included 156 menopausal women who received intrauterine lidocaine infusion or oral tramadol (50 mg) or placebo before diagnostic OH (52 women/group). Primary outcome was pain severity during the procedure using a 10-cm visual analog scale. Secondary outcomes were pain scores 10 and 30 min post procedure, satisfaction level, and ease of cervical entry. Results:  Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001). Tramadol had lower pain scores than placebo during the procedure ( p  = 0.04), 10 min after the procedure ( p  = 0.03), and 30 min after the procedure ( p  = 0.04). Both lidocaine and tramadol resulted in an easier procedure than placebo ( p  < 0.001 and  p  = 0.04, respectively). Lidocaine had an easier cervical entry compared to tramadol ( p  = 0.004). Satisfaction scores in the lidocaine and tramadol groups were significantly higher than in the placebo group ( p  < 0.001). Conclusions:  Lidocaine and tramadol were effective in reducing postmenopausal women-reported pain during and after diagnostic OH. However, lidocaine was better than tramadol in facilitating hysteroscope passage through the cervical canal and the reduction in pain levels with lidocaine was clinically relevant. Trial registration number:  NCT03701984.",2020,Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001).,"['before diagnostic OH (52 women/group', '156 menopausal women who received', 'postmenopausal women']","['Lidocaine', 'lidocaine', 'placebo', 'tramadol', 'intrauterine lidocaine infusion or oral tramadol (50\u2009mg) or placebo', 'diagnostic office hysteroscopy', 'Lidocaine and tramadol', 'Tramadol']","['pain levels', 'postmenopausal women-reported pain', 'lower pain scores', 'pain of diagnostic outpatient hysteroscopy (OH', 'Satisfaction scores', 'easier cervical entry', 'pain scores 10 and 30\u2009min post procedure, satisfaction level, and ease of cervical entry', 'efficacy and safety', 'pain severity during the procedure using a 10-cm visual analog scale', 'Pain management']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",156.0,0.686822,Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Abdelhakim', 'Affiliation': 'Department of Histology, Kasr Alainy, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Mahy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Abdel-Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1742685']
290,31578808,An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study.,"OBJECTIVE


To explore pregnant women's views of participation in a clinical research trial while pregnant.
DESIGN


Prospective nested qualitative cohort study embedded within a national, multi-site randomized controlled trial of a diagnostic test for preeclampsia: Placental Growth Factor. One-to-one in-depth semi-structured interviews were undertaken with 19 women who had recently participated in the trial at a single recruiting site. The interviews were conducted in private, recorded digitally and transcribed verbatim.
SETTING


Single tertiary maternity hospital currently recruiting eligible women onto an on-going randomized controlled trial (NCT02881073).
PARTICIPANTS


Women who had participated in the PARROT Ireland randomized controlled trial during their recent pregnancy.
METHODS


Thematic analysis was utilized. Each line of the transcribed interviews was coded into a category by two researchers. The resultant categories were reviewed, and those with similarities were pooled allowing the development of themes.
MAIN OUTCOME MEASURES


Women's opinions and experience of participation in a randomized controlled trial of an interventional diagnostic test during their pregnancy.
RESULTS


Four major themes were identified as follows: (a) Understanding of preeclampsia, (b) Motivators for clinical trial participation, (c) Barriers to decision making and (d) Influence of PARROT Ireland on pregnancy experience.
CONCLUSIONS


Women are generally interested and positively inclined to participate in research during pregnancy. The potential of risk is an important consideration for eligible pregnant woman. Information and support by both researchers and clinicians are paramount in aiding women's understanding of a research trial.",2020,One-to-one in-depth semi-structured interviews were undertaken with 19 women who had recently participated in the trial at a single recruiting site.,"[""pregnant women's"", 'eligible pregnant woman', '19 women who had recently participated in the trial at a single recruiting site', 'Single tertiary maternity hospital currently recruiting eligible women onto an on-going randomized controlled trial (NCT02881073', 'Women who had participated in the PARROT Ireland randomized controlled trial during their recent pregnancy']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1384490', 'cui_str': 'Psittacidae'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",[],[],,0.196612,One-to-one in-depth semi-structured interviews were undertaken with 19 women who had recently participated in the trial at a single recruiting site.,"[{'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Hayes-Ryan', 'Affiliation': 'The Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Meaney', 'Affiliation': 'National Perinatal Epidemiology Centre, University College Cork, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Nolan', 'Affiliation': 'The Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland.'}, {'ForeName': 'Keelin', 'Initials': 'K', 'LastName': ""O'Donoghue"", 'Affiliation': 'The Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.12969']
291,31144431,"Triple therapy with low-dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes.","AIM


To evaluate the efficacy and safety of triple therapy with low-dose dapagliflozin plus saxagliptin added to metformin in uncontrolled type 2 diabetes.
MATERIALS AND METHODS


This 24-week, double-blind trial (NCT02681094) randomized 883 patients (glycated haemoglobin [HbA1c] 7.5-10.0%) on metformin ≥1500 mg/d to add-on dapagliflozin 5 mg/d plus saxagliptin 5 mg/d or to add-on of either monocomponent. The primary endpoint was change in HbA1c from baseline.
RESULTS


Baseline mean ± SD patient characteristics were: age 56.7 ± 10.5 years; HbA1c 8.2 ± 0.9%; and diabetes duration 7.6 ± 6.1 years. Triple therapy significantly decreased HbA1c versus dual therapy (-1.03% vs. -0.63% [dapagliflozin] vs. -0.69% [saxagliptin]; P < .0001). More patients achieved HbA1c <7.0% with triple versus dual therapy (41.6% vs. 21.8% [dapagliflozin; P < .0001] vs. 29.8% [saxagliptin; P = .0018]). Triple therapy significantly decreased fasting plasma glucose (-1.5 mmol/L vs. -1.1 mmol/L [dapagliflozin; P = .0135] vs. -0.7 mmol/L [saxagliptin; P < .0001]) and body weight (-2.0 kg vs. -0.4 kg [saxagliptin; P < .0001]), and β-hydroxybutyrate levels were lower than with dapagliflozin plus metformin (mean difference -0.51; P = .0009). Urinary tract/genital infections and hypoglycaemia occurred in <5.0% and 5.8% of patients, respectively, with triple therapy.
CONCLUSIONS


Triple therapy with once-daily dapagliflozin 5 mg, saxagliptin 5 mg and metformin significantly improved glycaemic control versus dual therapy with either agent added to metformin in uncontrolled type 2 diabetes, and was generally well tolerated.",2019,Triple therapy significantly decreased HbA1c versus dual therapy (-1.03% vs. -0.63% [dapagliflozin] vs. -0.69% [saxagliptin]; P < .0001).,"['883 patients (glycated haemoglobin', 'Baseline mean\u2009±\u2009SD patient characteristics were: age 56.7\u2009±\u200910.5 years; HbA1c 8.2\u2009±\u20090.9%; and diabetes duration 7.6\u2009±\u20096.1 years', 'uncontrolled type 2 diabetes']","['dapagliflozin plus saxagliptin', 'metformin', 'dapagliflozin 5 mg, saxagliptin 5 mg and metformin', 'dapagliflozin plus metformin', 'monocomponent', 'saxagliptin', 'dapagliflozin']","['Urinary tract/genital infections and hypoglycaemia', 'tolerated', 'β-hydroxybutyrate levels', 'efficacy and safety', 'change in HbA1c from baseline', 'body weight', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3709923', 'cui_str': 'dapagliflozin 5 MG'}, {'cui': 'C2718464', 'cui_str': 'saxagliptin 5 MG [Onglyza]'}]","[{'cui': 'C0042027'}, {'cui': 'C0729552', 'cui_str': 'Infectious disease of genitopelvic system'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",883.0,0.0449488,Triple therapy significantly decreased HbA1c versus dual therapy (-1.03% vs. -0.63% [dapagliflozin] vs. -0.69% [saxagliptin]; P < .0001).,"[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Centre at Medical City, Dallas, Texas.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Perl', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'García-Sánchez', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Cardio-Metabolic Institute, Villingen-Schwenningen, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13795']
292,31541495,Triaging women with human papillomavirus infection and normal cytology or low-grade dyskaryosis: evidence from 10-year follow up of the ARTISTIC trial cohort.,"OBJECTIVES


To estimate long-term cervical intraepithelial neoplasia grade 3 (CIN3) risks associated with different triage strategies for human papillomavirus positive (HPV+) women with a view to reducing unnecessary referrals.
DESIGN


The ARTISTIC trial cohort was recruited in Manchester in 2001-03 and was followed up for CIN3 and cancer notification through national registration until December 2015.
RESULTS


The 10-year cumulative risk of CIN3+ was much higher for women with HPV16/18 infection (19.4%, 95% CI 15.8-23.8% with borderline/low-grade cytology and 10.7%, 95% CI 8.3-13.9% with normal cytology) than for those with other HPV types (7.3%, 95% CI 5.4-9.7% with borderline/low-grade cytology and 3.2%, 95% CI 2.2-4.5% with normal cytology). Among the 379 women with normal to low-grade cytology and new HPV infection, the 10-year cumulative CIN3+ risk was 2.9% (95% CI 1.6-5.2%).
CONCLUSIONS


The CIN3 risk is confined to women with persistent type-specific HPV so partial genotyping test assays identifying HPV16/18 as a minimum are essential for efficient risk stratification. Immediate referral to colposcopy for HPV+ women with borderline or low-grade cytology and referral after a year if still HPV+ with normal cytology may be unnecessary. Low-grade lesions can safely be retested to identify those with persistent HPV. Recall intervals of 1 year for HPV16/18 and 2 years for other high-risk HPVs are justified for women with normal cytology and might also be considered for women with borderline/low-grade cytology. The minimal risk of invasive cancer that has progressed beyond stage 1A must be weighed against the advantages for patients and the NHS of reducing the number of referrals to colposcopy.
TWEETABLE ABSTRACT


Cervical screening would be better for women and cheaper for the NHS if women with HPV and normal to low-grade cytology were retested after a year or two when many infections will have cleared.",2020,"The 10-year cumulative risk of CIN3+ was much higher for women with HPV16/18 infection (19.4%, 95% CI 15.8-23.8% with borderline/low-grade cytology and 10.7%, 95% CI 8.3-13.9% with normal cytology) than for those with other HPV types (7.3%, 95% CI 5.4-9.7% with borderline/low-grade cytology and 3.2%, 95% CI 2.2-4.5% with normal cytology).","['positive (HPV+) women with a view to reducing unnecessary referrals', 'Triaging women with\xa0human papillomavirus infection and\xa0normal cytology or low-grade dyskaryosis', '379 women with normal to low-grade cytology and new HPV infection', 'HPV+ women with borderline or low-grade cytology and referral after a year', 'trial cohort was recruited in Manchester in 2001-03 and was followed up for CIN3 and cancer notification through national registration until December 2015', 'human papillomavirus']",[],"['10-year cumulative risk of CIN3', '10-year cumulative CIN3+ risk']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0333901', 'cui_str': 'Dyskaryosis (morphologic abnormality)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1723187', 'cui_str': '3-(4-dimethylaminophenyl)-N-hydroxy-2-propenamide'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",379.0,0.286145,"The 10-year cumulative risk of CIN3+ was much higher for women with HPV16/18 infection (19.4%, 95% CI 15.8-23.8% with borderline/low-grade cytology and 10.7%, 95% CI 8.3-13.9% with normal cytology) than for those with other HPV types (7.3%, 95% CI 5.4-9.7% with borderline/low-grade cytology and 3.2%, 95% CI 2.2-4.5% with normal cytology).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gilham', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sargent', 'Affiliation': 'Clinical Virology, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Peto', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15957']
293,31562751,Rationale and design of the IRON-CRT trial: effect of intravenous ferric carboxymaltose on reverse remodelling following cardiac resynchronization therapy.,"AIMS


Iron deficiency is common in heart failure with reduced ejection fraction (HFrEF). In patients with cardiac resynchronization therapy (CRT), it is associated with a diminished reverse remodelling response and poor functional improvement. The latter is partially related to a loss in contractile force at higher heart rates (negative force-frequency relationship).
METHODS AND RESULTS


The effect of intravenous ferric carboxymaltose on reverse remodelling following cardiac resynchronization therapy (IRON-CRT) trial is a multicentre, prospective, randomized, double-blind controlled trial in HFrEF patients who experienced incomplete reverse remodelling (defined as a left ventricular ejection fraction below <45%) at least 6 months after CRT. Additionally, patients need to have iron deficiency defined as a ferritin below 100 μg/L irrespective of transferrin saturation or a ferritin between 100 and 300 μg/L with a transferrin saturation <20%. Patients will be randomized to either intravenous ferric carboxymaltose (dose based according to Summary of Product Characteristics) or intravenous placebo. The primary objective is to evaluate the effect of ferric carboxymaltose on metrics of cardiac reverse remodelling and contractility, measured by the primary endpoint, change in left ventricular ejection fraction assessed by three-dimensional (3D) echo from baseline to 3 month follow-up and the secondary endpoints change in left ventricular end-systolic and end-diastolic volume. The secondary objective is to determine if ferric carboxymaltose is capable of improving cardiac contractility in vivo, by assessing the force-frequency relationship through incremental biventricular pacing. A total of 100 patients will be randomized in a 1:1 fashion.
CONCLUSIONS


The IRON-CRT trial will determine the effect of ferric carboxymaltose on cardiac reverse remodelling and rate-dependent cardiac contractility in HFrEF patients.",2019,"The effect of intravenous ferric carboxymaltose on reverse remodelling following cardiac resynchronization therapy (IRON-CRT) trial is a multicentre, prospective, randomized, double-blind controlled trial in HFrEF patients who experienced incomplete reverse remodelling (defined as a left ventricular ejection fraction below <45%) at least 6 months after CRT.","['patients with cardiac resynchronization therapy (CRT', '100 patients', 'heart failure with reduced ejection fraction (HFrEF', 'HFrEF patients who experienced incomplete reverse remodelling (defined as a left ventricular ejection fraction below <45%) at least 6 months after CRT', 'HFrEF patients', 'patients need to have iron deficiency defined as a ferritin below 100 μg/L irrespective of transferrin saturation or a ferritin between 100 and 300 μg/L with a transferrin saturation <20']","['placebo', 'intravenous ferric carboxymaltose', 'ferric carboxymaltose']","['cardiac reverse remodelling and rate-dependent cardiac contractility', 'left ventricular end-systolic and end-diastolic volume', 'left ventricular ejection fraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}]","[{'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",100.0,0.290395,"The effect of intravenous ferric carboxymaltose on reverse remodelling following cardiac resynchronization therapy (IRON-CRT) trial is a multicentre, prospective, randomized, double-blind controlled trial in HFrEF patients who experienced incomplete reverse remodelling (defined as a left ventricular ejection fraction below <45%) at least 6 months after CRT.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Martens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Dauw', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Somers', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Herbots', 'Affiliation': 'Department of Cardiology, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Timmermans', 'Affiliation': 'Department of Cardiology, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Verwerft', 'Affiliation': 'Department of Cardiology, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}]",ESC heart failure,['10.1002/ehf2.12503']
294,31389157,Oral modified release morphine for breathlessness in chronic heart failure: a randomized placebo-controlled trial.,"AIMS


Morphine is shown to relieve chronic breathlessness in chronic obstructive pulmonary disease. There are no definitive data in people with heart failure. We aimed to determine the effectiveness and cost-effectiveness of 12 weeks morphine therapy for the relief of chronic breathlessness in people with chronic heart failure compared with placebo.
METHODS AND RESULTS


Parallel group, double-blind, randomized, placebo-controlled, phase III trial of 20 mg daily oral modified release morphine was conducted in 13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients. The primary analysis compared between-group numerical rating scale average breathlessness/24 hours at week 4 using a covariance pattern linear mixed model. Secondary outcomes included treatment-emergent harms (worse or new). The trial closed early due to slow recruitment, randomizing 45 participants [average age 72 (range 39-89) years; 84% men; 98% New York Heart Association class III]. For the primary analysis, the adjusted mean difference was 0.26 (95% confidence interval, -0.86 to 1.37) in favour of placebo. All other breathlessness measures improved in both groups (week 4 change-from-baseline) but by more in those assigned to morphine. Neither group was excessively drowsy at baseline or week 4. There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point. There was no exercise-related desaturation and no change between baseline and week 4 in either group. There was no change in vital signs at week 4. The natriuretic peptide measures fell in both groups but by more in the morphine group [morphine 2169 (1092, 3851) pg/mL vs. placebo 2851 (1694, 5437)] pg/mL. There was no excess serious adverse events in the morphine group. Treatment-emergent harms during the first week were more common in the morphine group; all apart from 1 were ≤ grade 2.
CONCLUSIONS


We could not answer our primary objectives due to inadequate power. However, we provide novel placebo-controlled medium-term benefit and safety data useful for clinical practice and future trial design. Morphine should only be prescribed in this population when other measures are unhelpful and with early management of side effects.",2019,There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point.,"['13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients', 'people with chronic heart failure compared with placebo', 'chronic obstructive pulmonary disease', '45 participants [average age 72 (range 39-89) years; 84% men; 98% New York Heart Association class III', 'people with heart failure', 'chronic heart failure']","['placebo', 'morphine therapy', '20 mg daily oral modified release morphine', 'Oral modified release morphine', 'morphine', 'Morphine']","['serious adverse events', 'effectiveness and cost-effectiveness', 'vital signs', 'excessively drowsy', 'chronic breathlessness', 'breathlessness measures', 'treatment-emergent harms (worse or new', 'quality of life (Kansas) or cognition (Montreal']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0518766'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",45.0,0.463956,There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point.,"[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Wolfson Palliative Care Research Centre, University of Hull, Hull, HU6 7RX, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Wolfson Palliative Care Research Centre, University of Hull, Hull, HU6 7RX, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hicks', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Hull York Medical School and York Trials Unit, University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jefferson', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Oxberry', 'Affiliation': 'Calderdale & Huddersfield Foundation Trust, Huddersfield Royal Infirmary, Huddersfield, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ghosh', 'Affiliation': 'Department of Cardiology, Scarborough Hospital, Scarborough, UK.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hogg', 'Affiliation': 'Department of Cardiology, Glasgow Royal Infirmary, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiology, Darlington Memorial Hospital, Darlington, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Hull York Medical School and Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics & Clinical Trials, Institute of Health & Well-being, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Clark', 'Affiliation': 'Hull York Medical School, Castle Hill Hospital, Cottingham, UK.'}]",ESC heart failure,['10.1002/ehf2.12498']
295,31324862,Effects of neuromuscular blockade reversal on bispectral index and frontal electromyogram during steady-state desflurane anesthesia: a randomized trial.,"The degree of neuromuscular blockade reversal may affect bispectral index (BIS) value. One possible reason is that the reverse of neuromuscular blockade affects electromyographic (EMG) signals of fascial muscle. Another reason is, the afferentation theory, the reverse of neuromuscular blockade relieves block signals generated in muscle stretch receptors from accessing the brain through afferent nerve pathways and induces arousal. Inaccurate BIS value may lead to overdose of drugs or the risk of intraoperative awareness. We compared changes in BIS and EMG values according to neuromuscular blockade reversal agents under steady-state desflurane anesthesia. A total of 65 patients were randomly allocated to receive either neostigmine 0.05 mg/kg, sugammadex 4 mg/kg, or pyridostigmine 0.25 mg/kg for neuromuscular blockade reversal under stable desflurane anesthesia, and 57 patients completed the study. The primary outcome was change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents (between train-of-four [TOF] count 1-2 and TOF ratio 0.9). The change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents were statistically different in each group (BIS: Neostigmine group, P < 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; EMG: Neostigmine group, P = 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; respectively). The BIS and EMG values had a positive correlation (P < 0.001). Our results demonstrate that the EMG and BIS values have increased after neuromuscular blockade reversal under desflurane anesthesia regardless of the type of neuromuscular blockade reversal agent. BIS should be applied carefully to measure of depth of anesthesia after neuromuscular blockade reversal.",2019,"The change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents were statistically different in each group (BIS: Neostigmine group, P < 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; EMG: Neostigmine group, P = 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; respectively).","['A total of 65 patients', 'steady-state desflurane anesthesia']","['Neostigmine', 'neostigmine 0.05\u2009mg/kg, sugammadex 4\u2009mg/kg, or pyridostigmine 0.25\u2009mg/kg for neuromuscular blockade reversal under stable desflurane anesthesia', 'neuromuscular blockade reversal', 'Pyridostigmine']","['BIS and EMG values', 'bispectral index and frontal electromyogram', 'change in BIS and EMG values', 'bispectral index (BIS) value']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0412773', 'cui_str': 'Reversal of neuromuscular blockade (procedure)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",65.0,0.164583,"The change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents were statistically different in each group (BIS: Neostigmine group, P < 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; EMG: Neostigmine group, P = 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; respectively).","[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunjoo', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ka Young', 'Initials': 'KY', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Seon', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. jiseon78.jeong@samsung.com.'}]",Scientific reports,['10.1038/s41598-019-47047-1']
296,31326669,Targeting separate specific learning parameters underlying cognitive behavioral therapy can improve perceptual judgments of anger.,"BACKGROUND AND OBJECTIVES


Anxiety disorders are characterized by biased perceptual judgment. An experimental model using simple verbal instruction to target specific decision parameters that influence perceptual judgment was developed to test if it could influence anger perception, and to examine differences between individuals with social anxiety disorder (SAD) relative to generalized anxiety disorder (GAD) or non-psychiatric controls.
METHODS


Anger perception was decomposed into three decision parameters (perceptual similarity of angry vs. not-angry facial expressions, base rate of encountering angry vs. not-angry expressions, payoff for correct vs. incorrect categorization of face stimuli) using a signal detection framework. Participants with SAD (n = 97), GAD (n = 90), and controls (n = 98) were assigned an instruction condition emphasizing one of the three decision parameters. Anger perception pre-vs. post-instruction and its interaction with diagnosis were examined.
RESULTS


For all participants, base rate instructions impacted response bias over and above practice effects, supporting the validity of this instructional task-based approach to altering response bias. We failed to find a similarity or payoff instruction effect, nor a diagnosis interaction.
LIMITATIONS


Future instructional tasks may need to more closely target core cognitive and perceptual biases in anxiety disorders to identify specific deficits and how to optimally influence them.
CONCLUSIONS


This study demonstrates that specific decision parameters underlying perceptual judgment can be experimentally manipulated. Although our study failed to show diagnosis specific effects, it suggests that individual parameter ""estimation"" deficits may be experimentally isolated and potentially targeted, with the ultimate goal of developing an objective approach to personalized intervention targeting biased perceptual judgments in anxiety disorders.",2019,"For all participants, base rate instructions impacted response bias over and above practice effects, supporting the validity of this instructional task-based approach to altering response bias.","['Participants with SAD (n\u202f=\u202f97), GAD (n\u202f=\u202f90), and controls (n\u202f=\u202f98', 'individuals with social anxiety disorder (SAD) relative to generalized anxiety disorder (GAD) or non-psychiatric controls']",[],"['perceptual judgments of anger', 'decision parameters (perceptual similarity of angry vs. not-angry facial expressions, base rate of encountering angry vs. not-angry expressions, payoff for correct vs. incorrect categorization of face stimuli']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}]",[],"[{'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0179269,"For all participants, base rate instructions impacted response bias over and above practice effects, supporting the validity of this instructional task-based approach to altering response bias.","[{'ForeName': 'Spencer K', 'Initials': 'SK', 'LastName': 'Lynn', 'Affiliation': 'Department of Psychology, Northeastern University, 360 Huntington Ave, Boston, MA, USA, 02115.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Harvard Medical School, 25 Shattuck St., Boston, MA 02115, Boston, MA, USA, 02114; Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, 1 Bowdoin St., Boston, MA, 02114, USA.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Harvard Medical School, 25 Shattuck St., Boston, MA 02115, Boston, MA, USA, 02114; Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, 1 Bowdoin St., Boston, MA, 02114, USA.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': ""O'Day"", 'Affiliation': 'Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, 1 Bowdoin St., Boston, MA, 02114, USA.'}, {'ForeName': 'Sophie A', 'Initials': 'SA', 'LastName': 'Palitz', 'Affiliation': 'Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, 1 Bowdoin St., Boston, MA, 02114, USA.'}, {'ForeName': 'Lisa F', 'Initials': 'LF', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychology, Northeastern University, 360 Huntington Ave, Boston, MA, USA, 02115; Psychiatric Neuroimaging Division, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, USA; Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'New York University School of Medicine, One Park Avenue 8th Floor, New York, NY, 10016, USA; Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, 1 Bowdoin St., Boston, MA, 02114, USA. Electronic address: Naomi.simon@nyulangone.org.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101498']
297,32297279,Feasibility and Outcome of a Phase II Study of Intensive Induction Chemotherapy in 91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment.,"INTRODUCTION


We prospectively tested in a phase II study high-dose aracytin and idarubicin plus amifostine as induction regimen in 149 patients with acute myeloid leukaemia (AML) aged ≥ 60 years, evaluated by a simplified multidimensional geriatric assessment (MGA).
METHODS


Ninety-one fully or partially fit patients (61%) were allocated to intensive chemotherapy and 58 (39%) frail patients to best supportive care (BSC). Intensively treated patients, showing early death and complete response (CR) rate respectively of 5.5% and 73.6%, received 61 consolidations, followed by autologous transplant (ASCT), stem cell transplantation (SCT) or gemtuzumab ozogamicin, depending on mobilization outcome and donor availability.
RESULTS


The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001). Hyperleukocytosis and cytogenetics were predictors of survival with a relative risk of 1.8 in patients with poor karyotype without hyperleukocytosis (p = 0.02) and 3 in those with hyperleukocytosis (≥ 50,000/μl) (p = 0.002).
CONCLUSION


MGA allowed tailored post-consolidation in 53.8% of patients after high-dose aracytin induction, with long-term survival doubling that reported in the literature after standard-dose cytarabine regimens.
TRIAL REGISTRATION


The study was registered with the Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.",2020,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","['149 patients with acute myeloid leukaemia (AML) aged ≥', '91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment', 'Ninety-one fully or partially fit patients (61', 'and 58 (39%) frail patients to best supportive care (BSC']","['Intensive Induction Chemotherapy', 'MGA', 'intensive chemotherapy', 'aracytin and idarubicin plus amifostine']","['8-year overall survival (OS', 'early death and complete response (CR) rate']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015020', 'cui_str': 'Amifostine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",149.0,0.066301,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Capelli', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy. debora.capelli@ospedaliriuniti.marche.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Saraceni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fiorentini', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Chiarucci', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Menotti', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Poloni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Discepoli', 'Affiliation': 'Cytogenetic Laboratory, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ospedale Salesi, via F. Corridoni, 11, 60100, Ancona, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Leoni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Olivieri', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01310-4']
298,32297283,OPADIA Study: Is a Patient Questionnaire Useful for Enhancing Physician-Patient Shared Decision Making on Physical Activity Micro-objectives in Diabetes?,"INTRODUCTION


Regular physical activity (PA) is recommended by all type 2 diabetes mellitus (T2DM) management guidelines. The OPADIA study aimed to determine whether using a specific patient questionnaire (Optima-PA©) could help T2DM patients increase their PA by leading to better physician-patient communication and improved levels of shared decision making concerning Specific, Measurable, Acceptable, Realistic, Timely (SMART)-PA micro-objectives.
METHODS


Physicians participating in this multicentre, prospective, randomised, real-life study were allocated to a standard group (T2DM patients managed according to usual clinical practice, n = 24) or the OPTIMA-PA group (additional use of the questionnaire, n = 30). The main outcome was the percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective. Other outcomes were the impact of the OPTIMA-PA questionnaire on patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels over a 3-month period (IPAQ-SF scores).
RESULTS


One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group. Unexpectedly, more inclusion visits ended with SMART-PA micro-objectives being set up in the standard group (p < 0.001): 81.1% (n = 99/122) versus 59.7% (n = 80/134). However, fewer patients in the OPTIMA-PA group felt that GPs made decisions alone (32% versus 60%; p < 0.0001). Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
CONCLUSION


Although the OPTIMA-PA questionnaire did not directly promote setting up of SMART-PA micro-objectives in T2DM patients, the OPADIA study demonstrated that this tool was effective at improving patient-physician relationships by increasing patient involvement in therapeutic decision making. Our study also highlighted the importance of GP aptitude for patient-centredness for improving PA in T2DM patients.",2020,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","['Physicians participating in this multicentre', 'T2DM patients', 'One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group']","['standard group (T2DM patients managed according to usual clinical practice, n\u2009=\u200924) or the OPTIMA-PA', 'Regular physical activity (PA']","['percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective', 'patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0003646', 'cui_str': 'Aptitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",122.0,0.0234986,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","[{'ForeName': 'Silla M', 'Initials': 'SM', 'LastName': 'Consoli', 'Affiliation': 'Paris Descartes University of Medicine, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University-Hospital (CHU), G. Montpied Hospital, INRA, UMR 1019, UNH, CRNH Auvergne, Clermont University, University of Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'Service de diabétologie, Institut E3M, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': ""Service d'endocrinologie, diabétologie et maladies métaboliques, Centre Hospitalier Sud-Francilien de Corbeil-Essonnes, Université Paris-Saclay, Orsay, France.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bineau', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Sabin', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Pouriel', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Freund', 'Affiliation': 'Clintec International SARL, Tour D2, 17 bis place des Reflets, 92099, La Défense, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Dejager', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France. sylvie.dejager@msd.com.'}]",Advances in therapy,['10.1007/s12325-020-01336-8']
299,31758633,What is the effect of a decision aid in potentially vulnerable parents? Insights from the head CT choice randomized trial.,"OBJECTIVE


To test the hypotheses that use of the Head CT Choice decision aid would be similarly effective in all parent/patient dyads but parents with high (vs low) numeracy experience a greater increase in knowledge while those with low (vs high) health literacy experience a greater increase in trust.
METHODS


This was a secondary analysis of a cluster randomized trial conducted at seven sites. One hundred seventy-two clinicians caring for 971 children at intermediate risk for clinically important traumatic brain injuries were randomized to shared decision making facilitated by the DA (n = 493) or to usual care (n = 478). We assessed for subgroup effects based on patient and parent characteristics, including socioeconomic status (health literacy, numeracy and income). We tested for interactions using regression models with indicators for arm assignment and study site.
RESULTS


The decision aid did not increase knowledge more in parents with high numeracy (P for interaction [P int  ] = 0.14) or physician trust more in parents with low health literacy (P int   = 0.34). The decision aid decreased decisional conflict more in non-white parents (decisional conflict scale, -8.14, 95% CI: -12.33 to -3.95; P int   = 0.05) and increased physician trust more in socioeconomically disadvantaged parents (trust in physician scale, OR: 8.59, 95% CI: 2.35-14.83; P int   = 0.04).
CONCLUSIONS


Use of the Head CT Choice decision aid resulted in less decisional conflict in non-white parents and greater physician trust in socioeconomically disadvantaged parents. Decision aids may be particularly effective in potentially vulnerable parents.",2020,"The decision aid decreased decisional conflict more in non-white parents (decisional conflict scale, -8.14, 95% CI: -12.33 to -3.95; P int   = 0.05) and increased physician trust more in socioeconomically disadvantaged parents (trust in physician scale, OR: 8.59, 95% CI: 2.35-14.83; P int   = 0.04).
","['socioeconomically disadvantaged parents', 'One hundred seventy-two clinicians caring for 971 children at intermediate risk for clinically important traumatic brain injuries']",['shared decision making facilitated by the DA (n\xa0=\xa0493) or to usual care'],"['socioeconomic status (health literacy, numeracy and income', 'decisional conflict', 'physician trust']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]","[{'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]",971.0,0.0774249,"The decision aid decreased decisional conflict more in non-white parents (decisional conflict scale, -8.14, 95% CI: -12.33 to -3.95; P int   = 0.05) and increased physician trust more in socioeconomically disadvantaged parents (trust in physician scale, OR: 8.59, 95% CI: 2.35-14.83; P int   = 0.04).
","[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Skains', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, University of California Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Homme', 'Affiliation': 'Division of Pediatric Emergency Medicine, Departments of Emergency Medicine and Pediatrics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Anupam B', 'Initials': 'AB', 'LastName': 'Kharbanda', 'Affiliation': ""Department of Pediatric Emergency Medicine, Children's Hospitals and Clinics of Minnesota, Minneapolis, MN, USA.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, University of California Davis School of Medicine, University of California Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Louie', 'Affiliation': 'Division of Pediatric Emergency Medicine, Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Cohen', 'Affiliation': ""Division of Emergency Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Westphal', 'Affiliation': 'Parent Representative, Rochester, MN, USA.'}, {'ForeName': 'Nilay D', 'Initials': 'ND', 'LastName': 'Shah', 'Affiliation': 'Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Inselman', 'Affiliation': 'Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Healthcare Delivery, Rochester, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ferrara', 'Affiliation': 'Division of Trauma, Critical Care and General Surgery, Departments of Emergency Medicine and Surgery, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Jeph', 'Initials': 'J', 'LastName': 'Herrin', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN, USA.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.12965']
300,31647614,Impaired glucose tolerance and albuminuria in patients with chronic heart failure: a subanalysis of the SUPPORT trial.,"AIMS


The study aims to evaluate the prognostic significance of impaired glucose tolerance (IGT) with reference to albuminuria in patients with chronic heart failure (CHF).
METHODS AND RESULTS


We examined 535 CHF patients (mean 66 years, women 25%) in the control arm of our SUPPORT trial, in which we examined additive impact of olmesartan in hypertensive patients with symptomatic CHF treated with β-blockers and/or angiotensin-converting enzyme inhibitors. We examined the association between glycaemic abnormality (assessed by 75 g of oral glucose tolerance test) and albuminuria for a composite outcome of all-cause death, myocardial infarction, stroke, and HF hospitalization. IGT patients (N = 113, mean 67.2 years) were older and more frequently treated with β-blockers compared with those with normal glucose regulation (N = 142, mean 64.0 years) and those with diabetes mellitus (N = 280, mean 65.7 years). Multivariable Cox proportional hazard models revealed that, as compared with normal glucose regulation (NGR), IGT was associated with increased risk of the outcome when complicated by albuminuria [hazard ratio (HR) 2.25; 95% confidence interval (CI) 1.14-4.42; P = 0.019] but not when uncomplicated by albuminuria (HR 0.76; 95% CI 0.35-1.60, P = 0.47) (P for interaction = 0.041). This was also the case for diabetes mellitus and albuminuria (HR 2.06; 95% CI 1.17-3.61; P = 0.012). Among IGT patients without albuminuria, 21 (29%) developed albuminuria at 1-year visit, which was again associated with poor prognosis (HR 7.36; 95% CI 1.39-38.98, P = 0.019).
CONCLUSIONS


These results indicate that IGT is associated with poor prognosis when complicated by albuminuria in CHF patients, demonstrating the importance of combined early stages of glucose intolerance and renal dysfunction in the management of CHF.",2019,This was also the case for diabetes mellitus and albuminuria (HR 2.06; 95% CI 1.17-3.61; P = 0.012).,"['mean 64.0\u2009years) and those with diabetes mellitus (N\u2009=\u2009280, mean 65.7\u2009years', 'hypertensive patients with symptomatic CHF treated with β-blockers and/or angiotensin-converting enzyme inhibitors', 'patients with chronic heart failure', 'IGT patients (N\u2009=\u2009113, mean 67.2\u2009years) were older and more frequently treated with β-blockers compared with those with normal glucose regulation (N\u2009=\u2009142', 'patients with chronic heart failure (CHF', '535 CHF patients (mean 66\u2009years, women 25%) in the control arm of our SUPPORT trial']","['IGT', 'glucose tolerance (IGT', 'olmesartan']","['albuminuria at 1-year visit', 'glucose tolerance and albuminuria', 'death, myocardial infarction, stroke, and HF hospitalization']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1098320', 'cui_str': 'olmesartan'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",535.0,0.0548759,This was also the case for diabetes mellitus and albuminuria (HR 2.06; 95% CI 1.17-3.61; P = 0.012).,"[{'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Nochioka', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Seiryo-machi 1-1, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Seiryo-machi 1-1, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Miura', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Seiryo-machi 1-1, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shiroto', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Seiryo-machi 1-1, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Seiryo-machi 1-1, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Saga', 'Affiliation': 'Department of Evidence-based Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Ikeno', 'Affiliation': 'Department of Evidence-based Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Shiba', 'Affiliation': 'Department of Cardiovascular Medicine, International University of Health and Welfare Hospital, Tochigi, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Shinozaki', 'Affiliation': 'Cardiovascular Division, Sendai Medical Center, National Hospital Organization, Miyagi, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Sugi', 'Affiliation': 'Cardiovascular Division, Iwaki City Medical Center, Fukushima, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Iwate Prefectural Isawa Hospital, Iwate, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Komaru', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku Medical and Pharmaceutical University, Miyagi, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiovascular Medicine, Sendai Open Hospital, Miyagi, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nozaki', 'Affiliation': 'Department of Cardiovascular Medicine, Iwate Prefectural Central Hospital, Iwate, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Iwabuchi', 'Affiliation': 'Cardiovascular Division, Osaki Citizen Hospital, Miyagi, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hiramoto', 'Affiliation': 'Cardiovascular Division, Kurihara Central Hospital, Miyagi, Japan.'}, {'ForeName': 'Kanichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Cardiovascular Division, Senen Rifu Hospital, Miyagi, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Ohe', 'Affiliation': 'Cardiovascular Division, Kojirakawa Shieido Hospital, Miyagi, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamaki', 'Affiliation': 'Cardiology Department, Iwate Health Service Association, Iwate, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Tsuji', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Seiryo-machi 1-1, Sendai, Miyagi, 980-8574, Japan.'}]",ESC heart failure,['10.1002/ehf2.12516']
301,31638338,Activity Sensors to Evaluate the Effect of Sacubitril/Valsartan on Quality-of-Life in Heart Failure: rational and design of the AWAKE-HF study.,"AIMS


Limited data are available regarding the ability of sacubitril/valsartan to provide clinically meaningful health-related quality of life (HRQoL) improvements among individuals with heart failure (HF). Objective measurement of physical activity and sleep using actigraphy can provide insight into daily functioning and HRQoL.
METHODS AND RESULTS


We designed an 18 week, multicenter, randomized, double-blind, double-dummy, parallel-group study to objectively assess changes in function and HRQoL directly after initiating sacubitril/valsartan vs. enalapril in participants with HF in their home environments. A total of 136 outpatient, ambulatory participants with New York Heart Association Class II or III HF with reduced ejection fraction (HFrEF) will be included in the study. Patients will undergo a 2 week baseline observational phase (continuing current HF treatment); data from the second week of this phase will be the baseline value for comparison with those of subsequent periods. Patients will then enter an 8 week blinded-treatment phase (randomly assigned 1:1 to sacubitril/valsartan or enalapril), followed by an 8 week open-label extension phase (treatment with only sacubitril/valsartan). The primary efficacy endpoint is the change in mean activity counts during the most active 30 min of the participant's day between baseline and the final randomized treatment phase measurement. Secondary endpoints include the change in mean sleep activity during the randomized and open-label phases; questionnaires will also assess HRQoL measures. Rather than analysing pooled actigraphy data, the researchers are considering each participant to be acting as his or her own control.
CONCLUSIONS


This will be the first study to assess the effects of sacubitril/valsartan on objective measures of sleep and activity in individuals with HFrEF within the context of their daily lives. Wearable accelerometer devices will be used to gain insight into how the medication affects physical activity and sleep.",2019,The primary efficacy endpoint is the change in mean activity counts during the most active 30 min of the participant's day between baseline and the final randomized treatment phase measurement.,"['individuals with HFrEF within the context of their daily lives', '136 outpatient, ambulatory participants with New York Heart Association Class II or III HF with reduced ejection fraction (HFrEF) will be included in the study', 'participants with HF in their home environments', 'individuals with heart failure (HF', 'heart failure']","['sacubitril/valsartan', 'sacubitril/valsartan or enalapril), followed by an 8-week open-label extension phase (treatment with only sacubitril/valsartan', 'sacubitril/valsartan vs. enalapril']","['function and HRQoL directly', 'quality-of-life', 'mean activity counts', 'HRQoL measures', 'change in mean sleep activity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",30.0,0.134018,The primary efficacy endpoint is the change in mean activity counts during the most active 30 min of the participant's day between baseline and the final randomized treatment phase measurement.,"[{'ForeName': 'Raj M', 'Initials': 'RM', 'LastName': 'Khandwalla', 'Affiliation': 'Cedars-Sinai Heart Institute, 250 N Robertson Blvd, Suite #403, Beverly Hills, Los Angeles, CA, USA.'}, {'ForeName': 'Kade', 'Initials': 'K', 'LastName': 'Birkeland', 'Affiliation': 'Cedars-Sinai Heart Institute, 250 N Robertson Blvd, Suite #403, Beverly Hills, Los Angeles, CA, USA.'}, {'ForeName': 'J Thomas', 'Initials': 'JT', 'LastName': 'Heywood', 'Affiliation': 'Scripps Clinic, San Diego, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Steinhubl', 'Affiliation': 'Scripps Clinic, San Diego, CA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCague', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Fombu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grant', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Jerome B', 'Initials': 'JB', 'LastName': 'Riebman', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'University of California, San Diego School of Medicine, San Diego, CA, USA.'}]",ESC heart failure,['10.1002/ehf2.12514']
302,32297937,Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men.,"BACKGROUND


Fructose ingestion with a high-fat beverage increases postprandial lipemia when compared with glucose. It is unknown whether other sugars, such as galactose, also increase postprandial lipemia.
OBJECTIVES


The objective was to assess whether galactose ingestion within a high-fat beverage increases postprandial lipemia relative to glucose or fructose.
METHODS


Two experiments were conducted, which contrasted different test drinks under otherwise standardized conditions. In Experiment 1, 10 nonobese men (age: 22 ± 1 y; BMI, 23.5 ± 2.2 kg/2) ingested either galactose or glucose (0.75 g supplemented carbohydrate per⋅kilogram body mass) within a high-fat test drink (0.94 g fat per kilogram body mass). In Experiment 2, a separate group of 9 nonobese men (age: 26 ± 6 y; BMI: 23.5 ± 2.6 kg/m2) ingested either galactose or fructose (identical doses as those in Experiment 1) within the same high-fat test drink. Capillary blood was sampled before and at frequent intervals after ingestion of the test drinks for a 300-min period to determine plasma triacylglycerol, glucose, lactate, nonesterified fatty acid, and insulin concentrations. Paired t tests and 2-way, repeated-measures ANOVA were used to compare conditions within each experiment.
RESULTS


The incremental AUC for triacylglycerol was greater following galactose ingestion compared with glucose (127 ± 59 compared with 80 ± 48 mmol⋅L-1 × 300 min, respectively; P = 0.04) but not compared with fructose (136 ± 74 compared with 133 ± 63 mmol⋅L-1 ×300 min, respectively; P = 0.91). Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17).
CONCLUSIONS


Galactose ingestion within a high-fat beverage exacerbates postprandial lipemia and plasma lactate concentrations compared with glucose but not fructose in nonobese men. These data suggest that galactose metabolism may be more similar to fructose than to glucose, providing a rationale to reassess the metabolic fate of galactose ingestion in humans. This trial was registered at clinicaltrials.gov as NCT03439878.",2020,"Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17).
","['10 nonobese men (age: 22\xa0±\xa01 y; BMI, 23.5\xa0±\xa02.2 kg/2) ingested either', 'nonobese men', '9 nonobese men (age: 26\xa0±\xa06 y; BMI: 23.5\xa0±\xa02.6 kg/m2) ingested either', 'Healthy Men']","['galactose or glucose (0.75 g supplemented carbohydrate per⋅kilogram body mass) within a high-fat test drink', 'galactose or fructose (identical doses as those in Experiment 1) within the same high-fat test drink']","['postprandial lipemia relative to glucose or fructose', 'Capillary blood', 'Plasma lactate concentrations', 'incremental AUC for triacylglycerol', 'postprandial lipemia', 'Postprandial Lipemia', 'plasma triacylglycerol, glucose, lactate, nonesterified fatty acid, and insulin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0016945', 'cui_str': 'Galactose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",2.0,0.0461634,"Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17).
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Holliday', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Deighton', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa105']
303,32108364,ERP evidence suggests that confrontation with deterministic statements aligns subsequent other- and self-relevant error processing.,"This study used event-related potential (ERP) measurements to investigate whether error processing in a social context is modulated by top-down influence of deterministic thinking, i.e., subjective beliefs that events are pre-determined by previously existing causes. To this end, half of our participants were confronted with statements denying the existence of free will, aimed to induce more deterministic thinking, whereas the other half was assigned to a control group that read neutral statements. Thereafter, all participants performed a choice-reaction task for their own and for the benefit of a second participant. Error rates were comparable in both groups and benefit settings, while only control participants showed enhanced post-error slowing (PES) in other- compared to self-relevant trials. On the neural level, other-relevant errors elicited diminished early error signals (reduced ΔERN amplitudes) in deterministic-intervention participants compared to controls. In subsequent processing, ERPs of deterministic-intervention participants did not differentiate between the benefit settings, while controls showed reduced ΔPe amplitudes for others compared to self-relevant errors. Taken together, our findings suggest that being confronted with deterministic compared to control statements reduced subsequent processing differences between other- and self-relevant error processing. This might be beneficial in social evaluation or intergroup situations because it could decrease self-cenetred processing biases often observed in these situations.",2020,"In subsequent processing, ERPs of deterministic-intervention participants did not differentiate between the benefit settings, while controls showed reduced ΔPe amplitudes for others compared to self-relevant errors.",[],[],"['Error rates', 'ΔPe amplitudes', 'enhanced post-error slowing (PES']",[],[],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}]",,0.0610241,"In subsequent processing, ERPs of deterministic-intervention participants did not differentiate between the benefit settings, while controls showed reduced ΔPe amplitudes for others compared to self-relevant errors.","[{'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Pfabigan', 'Affiliation': 'Department of Behavioural Sciences in Medicine, Institute for Basic Medical Science, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Mielacher', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Preventive and Occupational Medicine, WittyFit, Clermont-Ferrand, France.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}]",Psychophysiology,['10.1111/psyp.13556']
304,32246765,Therapeutic role of granulocyte macrophage colony-stimulating factor (GM-CSF) in patients with persistent thin endometrium: A prospective and randomized study.,"OBJECTIVE


To assess the effect of granulocyte macrophage colony-stimulating factor (GM-CSF) on unresponsive thin (<7 mm) endometrium in women undergoing frozen-thawed embryo transfer.
METHODS


A single-center, randomized, prospective study enrolled 304 women with thin unresponsive endometrium from Shanghai Ninth People's Hospital between March 2017 and May 2018. Of them, 161 patients received an intrauterine infusion of GM-CSF and 143 patients served as controls. After hysteroscopy, a gel with or without GM-CSF was administered to fill the uterine cavity completely or up to 5 mL only. The primary outcome was confirmed pregnancy and secondary outcomes included endometrial thickness and implantation rate.
RESULTS


Patients who were administered GM-CSF had a significantly higher chemical pregnancy rate (35.3% vs 20.0%; P=0.009) and clinical pregnancy rate (28.6% vs 13.3%; P=0.005) compared with patients in the control group. Patients treated with GM-CSF had significantly higher endometrial thickness compared with controls (7.83 ± 1.45 mm vs 7.37 ± 0.70 mm, P=0.003).
CONCLUSION


GM-CSF therapy can effectively increase endometrial thickness and improve the clinical pregnancy rate in patients with persistent thin endometrium. The therapeutic role of GM-CSF for infertile women under in vitro fertilization and embryo transfer (IVF-ET) treatment can be further explored.
CHINESE CLINICAL TRIAL REGISTER


ChiCTR-IPR-17011242.",2020,"Patients treated with GM-CSF had significantly higher endometrial thickness compared with controls (7.83±1.45 mm vs 7.37±0.70 mm, P=0.003).
","['patients with persistent thin endometrium', '161 patients received an', 'infertile women under in vitro fertilization and embryo transfer (IVF-ET', 'women undergoing frozen-thawed embryo transfer', ""304 women with thin unresponsive endometrium from Shanghai Ninth People's Hospital between March 2017 and May 2018""]","['intrauterine infusion of GM-CSF', 'GM-CSF', 'gel-with or without GM-CSF', 'GM-CSF therapy', 'granulocyte macrophage colony-stimulating factor (GM-CSF']","['endometrial thickness and implantation rate', 'clinical pregnancy rate', 'chemical pregnancy rate', 'endometrial thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0860381', 'cui_str': 'GM-CSF therapy'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}]",304.0,0.0945502,"Patients treated with GM-CSF had significantly higher endometrial thickness compared with controls (7.83±1.45 mm vs 7.37±0.70 mm, P=0.003).
","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Renfei', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shaozhen', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13152']
305,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


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


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


At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
306,31149704,Cryptococcal Meningitis Screening and Community-based Early Adherence Support in People With Advanced Human Immunodeficiency Virus Infection Starting Antiretroviral Therapy in Tanzania and Zambia: A Cost-effectiveness Analysis.,"BACKGROUND


A randomized trial demonstrated that among people living with late-stage human immunodeficiency virus (HIV) infection initiating antiretroviral therapy, screening serum for cryptococcal antigen (CrAg) combined with adherence support reduced all-cause mortality by 28%, compared with standard clinic-based care. Here, we present the cost-effectiveness.
METHODS


HIV-infected adults with CD4 count <200 cells/μL were randomized to either CrAg screening plus 4 weekly home visits to provide adherence support or to standard clinic-based care in Dar es Salaam and Lusaka. The primary economic outcome was health service care cost per life-year saved as the incremental cost-effectiveness ratio (ICER), based on 2017 US dollars. We used nonparametric bootstrapping to assess uncertainties and univariate deterministic sensitivity analysis to examine the impact of individual parameters on the ICER.
RESULTS


Among the intervention and standard arms, 1001 and 998 participants, respectively, were enrolled. The annual mean cost per participant in the intervention arm was US$339 (95% confidence interval [CI], $331-$347), resulting in an incremental cost of the intervention of US$77 (95% CI, $66-$88). The incremental cost was similar when analysis was restricted to persons with CD4 count <100 cells/μL. The ICER for the intervention vs standard care, per life-year saved, was US$70 (95% CI, $43-$211) for all participants with CD4 count up to 200 cells/μL and US$91 (95% CI, $49-$443) among those with CD4 counts <100 cells /μL. Cost-effectveness was most sensitive to mortality estimates.
CONCLUSIONS


Screening for cryptococcal antigen combined with a short period of adherence support, is cost-effective in resource-limited settings.",2020,The incremental cost was similar when analysis was restricted to persons with CD4 count <100 cells,"['1,001 and 998 participants from the intervention and standard arms were enrolled respectively', 'people with advanced HIV infection starting antiretroviral therapy in Tanzania and Zambia', 'persons with CD4 count <100 cells', 'HIV-infected adults with CD4 count<200 cells/μl']",['CrAg screening plus 4-weekly home visits conducted by lay-workers to provide adherence support or to standard clinic-based care in Dar es Salaam and in Lusaka'],"['incremental cost', 'Unit costs', 'health service care cost per life year saved as the incremental cost-effectiveness ratio (ICER), based on 2017 US', 'cost-effectiveness estimates', 'cost-effectiveness', 'annual mean costs']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.151352,The incremental cost was similar when analysis was restricted to persons with CD4 count <100 cells,"[{'ForeName': 'Godfather Dickson', 'Initials': 'GD', 'LastName': 'Kimaro', 'Affiliation': 'Muhimbili Medical Research Centre, National Institute of Medical Research, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Guinness', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Tinevimbo', 'Initials': 'T', 'LastName': 'Shiri', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'Muhimbili Medical Research Centre, National Institute of Medical Research, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Chanda', 'Affiliation': 'University Teaching Hospital, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Kahwa', 'Affiliation': 'Muhimbili Medical Research Centre, National Institute of Medical Research, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Hawkins', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mwaba', 'Affiliation': 'Department of Internal Medicine and Directorate of Research and Postgraduate Studies, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Sayoki Godfrey', 'Initials': 'SG', 'LastName': 'Mfinanga', 'Affiliation': 'Muhimbili Medical Research Centre, National Institute of Medical Research, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Institute for Infection and Immunity, Centre for Global Health, St George's University of London, United Kingdom.""}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Louis W', 'Initials': 'LW', 'LastName': 'Niessen', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz453']
307,31152196,"Size does matter: ureteral stents with a smaller diameter show advantages regarding urinary symptoms, pain levels and general health.","OBJECTIVE


To compare the effect of different diameters of ureteral stents (F4.7, F6, and F7) on quality of life regarding the subdomains of the Ureteral Stent Symptom Questionnaire.
MATERIALS AND METHODS


All patients undergoing URS between April 2016 and July 2017 were prospectively randomised for ureteral stents F4.7, F6 and F7, respectively. All patients with other pathologies than a ureter stone, ureteral stents on both sides or other therapy than a secondary URS were excluded. Readmitted patients were interviewed using the USSQ. Furthermore, success rates of the second URS were also noted.
RESULTS


Between April 2016 to July 2017, 181 patients were included, 48 with a ureteral stent F4.6, 66 with F6 and 67 with F7. No significant differences in age, gender or position of the stones before URS were found (all p > 0.5). Comparing scores of USSQ between F4.7 and F6 or F6 and F7, scores were in favour of the smaller stent, but significance was only reached in ""Work performance score"" (F6-F7, p = 0.04) and ""Urinary index score"" (F4.7-F6, p = 0.004). When comparing F4.7 with F7, significant differences in all subgroups in favour of F4.7 were documented (all p < 0.03). Surgical success of the second URS was comparable in all groups (all above 82%, p > 0.15).
CONCLUSION


Discomfort and pain increase with the diameter of the indwelling ureter stent, while the success of the following URS is not compromised by a ureter stent with a smaller diameter. Therefore, ureteral stents with a small diameter should be preferred.",2020,"Surgical success of the second URS was comparable in all groups (all above 82%, p > 0.15).
","['Between April 2016 to July 2017', 'All patients undergoing URS between April 2016 and July 2017', '181 patients were included, 48 with a ureteral stent F4.6, 66 with F6 and 67 with F7', 'All patients with other pathologies than a ureter stone, ureteral stents on both sides or other therapy than a secondary URS were excluded']","['ureteral stents (F4.7, F6, and F7']","['Work performance score', 'quality of life regarding the subdomains of the Ureteral Stent Symptom Questionnaire', 'age, gender or position of the stones before URS', 'Surgical success of the second URS', 'Urinary index score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C1286385', 'cui_str': 'Performance at Work'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",181.0,0.0196006,"Surgical success of the second URS was comparable in all groups (all above 82%, p > 0.15).
","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Nestler', 'Affiliation': 'Department of Urology, Hochtaunusklinik Bad Homburg, Bad Homburg, Germany. sebastian-nestler@web.de.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Witte', 'Affiliation': 'Department of Urology, Hochtaunusklinik Bad Homburg, Bad Homburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schilchegger', 'Affiliation': 'Department of Urology, Hochtaunusklinik Bad Homburg, Bad Homburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Department of Urology, Hochtaunusklinik Bad Homburg, Bad Homburg, Germany.'}]",World journal of urology,['10.1007/s00345-019-02829-0']
308,31462757,Sprint interval training versus moderate-intensity continuous training during inpatient rehabilitation after spinal cord injury: a randomized trial.,"STUDY DESIGN


Randomized trial.
OBJECTIVES


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


Inpatient rehabilitation.
METHODS


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


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


Five weeks of SIT improved physical capacity to the same extent as MICT in individuals with sub-acute SCI, despite a significantly lower time commitment with SIT.",2020,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","['inpatient rehabilitation after spinal cord injury', 'Individuals with SCI (N\u2009', 'Inpatient rehabilitation', '20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46\u2009±\u200916 years; 15\u2009M/5\u2009F', 'individuals with sub-acute spinal cord injury (SCI']","['MICT', 'SIT or moderate-intensity continuous training (MICT', 'Sprint interval training versus moderate-intensity continuous training', '5-week sprint interval training (SIT) protocol']","['sub-maximal power output', 'Exercise enjoyment, exercise self-efficacy, and pain', ""Heart rate and Borg's Rating of Perceived Exertion"", 'Peak power output', 'heart rate', 'physical capacity', 'exercise enjoyment', 'peripheral RPE', 'exercise self-efficacy', 'central RPE']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0449246', 'cui_str': 'Time since injury (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",780.0,0.0764155,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Mcleod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Herrington', 'Initials': 'H', 'LastName': 'Diana', 'Affiliation': 'Regional Rehabilitation Centre, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada. hicksal@mcmaster.ca.'}]",Spinal cord,['10.1038/s41393-019-0345-6']
309,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS


This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE


Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS


The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
310,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS


Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
311,31324831,Accurate Detection of Dobutamine-induced Haemodynamic Changes by Kino-Cardiography: A Randomised Double-Blind Placebo-Controlled Validation Study.,"Non-invasive remote detection of cardiac and blood displacements is an important topic in cardiac telemedicine. Here we propose kino-cardiography (KCG), a non-invasive technique based on measurement of body vibrations produced by myocardial contraction and blood flow through the cardiac chambers and major vessels. KCG is based on ballistocardiography and measures 12 degrees-of-freedom (DOF) of body motion. We tested the hypothesis that KCG reliably assesses dobutamine-induced haemodynamic changes in healthy subjects. Using a randomized double-blinded placebo-controlled crossover study design, dobutamine and placebo were infused to 34 volunteers (25 ± 2 years, BMI 22 ± 2 kg/m², 18 females). Baseline recordings were followed by 3 sessions of increasing doses of dobutamine (5, 10, 20 μg/kg.min) or saline solution. During each session, stroke volume (SV) and cardiac output (CO) were determined by echocardiography and followed by a 90 s KCG recording. Measured linear accelerations and angular velocities were used to compute total Kinetic energy (iK) and power (Pmax). KCG sorted dobutamine infusion vs. placebo with 96.9% accuracy. Increases in SV and CO were correlated to iK (r = +0.71 and r = +0.8, respectively, p < 0.0001). Kino-cardiography, with 12-DOF, allows detecting dobutamine-induced haemodynamic changes with a high accuracy and present a major improvement over single axis ballistocardiography or seismocardiography.",2019,KCG sorted dobutamine infusion vs. placebo with 96.9% accuracy.,"['healthy subjects', '34 volunteers (25\u2009±\u20092 years, BMI 22\u2009±\u20092\u2009kg/m², 18 females']","['Kino-Cardiography', 'KCG', 'saline solution', 'placebo', 'dobutamine and placebo', 'kino-cardiography (KCG', 'KCG sorted dobutamine infusion vs. placebo', 'Placebo', 'dobutamine']","['SV and CO', 'stroke volume (SV) and cardiac output (CO', 'total Kinetic energy (iK) and power (Pmax']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",34.0,0.325333,KCG sorted dobutamine infusion vs. placebo with 96.9% accuracy.,"[{'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Hossein', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium. amin.hossein@ulb.ac.be.'}, {'ForeName': 'Daniela Corina', 'Initials': 'DC', 'LastName': 'Mirica', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Rabineau', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'José Ignacio Del', 'Initials': 'JID', 'LastName': 'Rio', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Morra', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gorlier', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Nonclercq', 'Affiliation': 'BEAMS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'van de Borne', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Migeotte', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}]",Scientific reports,['10.1038/s41598-019-46823-3']
312,30886131,The analgesic efficacy of the transversalis fascia plane block in iliac crest bone graft harvesting: a randomized controlled trial.,"BACKGROUND


Iliac crest bone graft (ICBG) harvesting is associated with significant perioperative pain and opioid consumption. This randomized controlled trial sought to determine if the transversalis fascia plane (TFP) block provides effective analgesia for anterior ICBG harvesting.
METHODS


Fifty patients undergoing wrist fusion surgery with anterior ICBG harvesting were randomized to receive a TFP block with either 20 ml of 0.5% ropivacaine or 5% dextrose. Patients additionally received a brachial plexus block for primary surgical-site anesthesia and either a general or spinal anesthetic depending on patient preference. Primary outcomes of interest were perioperative opioid consumption (measured as intravenous morphine equivalents [IME]), pain intensity at the ICBG harvest site for up to 48 h postoperatively, and the incidence of persistent postoperative pain at 6 and 12 months after surgery.
RESULTS


The TFP group used less opioid in the post-anesthetic care unit (PACU) (median 0 vs. 2.5 mg IME, P = 0.01) and in the first 8 h following PACU discharge (median 2.5 vs. 13.0 mg IME, P = 0.02). The patients who received a TFP block also had lower pain scores in PACU (median 0 vs. 4.0 out of 10, P < 0.001). Although opioid consumption and pain scores were lower in the TFP group at later timepoints, this difference was not statistically significant. Persistent pain at the ICBG site was reported in only 4.3% and 6.5% of all patients at 6 and 12 months, respectively.
CONCLUSIONS


The TFP block provides effective early analgesia for anterior ICBG harvesting. The incidence of persistent postoperative pain was low.",2019,The patients who received a TFP block also had lower pain scores in PACU (p<0.001).,"['Fifty patients undergoing wrist fusion surgery with anterior ICBG harvesting', 'iliac crest bone graft harvesting']","['TFP block with either 20 mL of 0.5% ropivacaine or 5% dextrose', 'transversalis fascia plane (TFP) block', '\n\n\nIliac crest bone graft (ICBG', 'TFP', 'brachial plexus block for primary surgical site anesthesia and either a general or spinal anesthetic depending on patient preference', 'TFP block']","['analgesic efficacy', 'perioperative opioid consumption (measured as intravenous morphine equivalents), pain intensity at the ICBG harvest site for up to 48 hours post-operatively and the incidence of persistent post-operative pain', 'pain scores', 'incidence of persistent postoperative pain', 'Persistent pain', 'opioid consumption and pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0223651', 'cui_str': 'Iliac Crest'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0223651', 'cui_str': 'Iliac Crest'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",50.0,0.267848,The patients who received a TFP block also had lower pain scores in PACU (p<0.001).,"[{'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Black', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Laith', 'Initials': 'L', 'LastName': 'Malhas', 'Affiliation': 'Department of Anesthesia, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Chan', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ki Jinn', 'Initials': 'KJ', 'LastName': 'Chin', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}]",Korean journal of anesthesiology,['10.4097/kja.d.18.00352']
313,31312016,Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


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


An outpatient clinic, Iran.
METHODS


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


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


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


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


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Torkaman', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. torkamg@modares.ac.ir.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Ghabaee', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Departments of Medicine and Endocrinology, Austin Health, The University of Melbourne, Melbourne, VIC, Australia.'}]",Spinal cord,['10.1038/s41393-019-0328-7']
314,32294881,"Health Outcomes of an Integrated Behaviour-Centred Water, Sanitation, Hygiene and Food Safety Intervention-A Randomised before and after Trial.","Diarrhoeal disease in children under five in low income settings has been associated with multiple environmental exposure pathways, including complementary foods. Conducted from February to December 2018 in rural Malawi, this before and after trial with a control used diarrhoeal disease as a primary outcome, to measure the impact of a food hygiene intervention (food hygiene + handwashing) relative to a food hygiene and water, sanitation and hygiene (WASH) intervention (food hygiene + handwashing + faeces management + water management). The 31-week intervention was delivered by community-based coordinators through community events ( n  = 2), cluster group meetings ( n  = 17) and household visits ( n  = 14). Diarrhoeal disease was self-reported and measured through an end line survey, and daily diaries completed by caregivers. Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group. There were also significant increases in the presence of proxy measures in each of the treatment groups (e.g., the presence of soap). We conclude that food hygiene interventions (including hand washing with soap) can significantly reduce diarrhoeal disease prevalence in children under five years in a low-income setting. Therefore, the promotion of food hygiene practices using a behaviour-centred approach should be embedded in nutrition and WASH policies and programming.",2020,Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group.,"['children under five in low income settings', 'children under five years in a low-income setting']","['food hygiene interventions (including hand washing with soap', 'food hygiene intervention (food hygiene + handwashing) relative to a food hygiene and water, sanitation and hygiene (WASH) intervention (food hygiene + handwashing + faeces management + water management', 'Integrated Behaviour-Centred Water, Sanitation, Hygiene and Food Safety']","['self-reported diarrhoea', 'Diarrhoeal disease', 'presence of proxy measures', 'diarrhoeal disease prevalence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0252993,Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group.,"[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Centre for Water, Environment, Sustainability and Public Health, Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow G1 1XJ, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tilley', 'Affiliation': 'Department of Environmental Health, University of Malawi (Polytechnic), Blantyre, Malawi.'}, {'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Centre for Water, Environment, Sustainability and Public Health, Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow G1 1XJ, UK.'}, {'ForeName': 'Rossanie', 'Initials': 'R', 'LastName': 'Malolo', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), University of Malawi (Polytechnic), Blantyre, Malawi.'}, {'ForeName': 'Janelisa', 'Initials': 'J', 'LastName': 'Musaya', 'Affiliation': 'Department of Biochemical Sciences, College of Medicine, University of Malawi, Blantyre, Malawi.'}]",International journal of environmental research and public health,['10.3390/ijerph17082648']
315,31721249,Lower urine sodium predicts longer length of stay in acute heart failure patients: Insights from the ROSE AHF trial.,"BACKGROUND


In patients hospitalized with acute heart failure (AHF), low urine sodium concentration (U Na  ) after diuretic treatment may identify patients at risk for longer length of stay (LOS) and adverse events. We investigated the prognostic significance of 24-hour cumulative postdiuretic urine sodium concentration in a multicenter clinical trial population.
METHODS


The Renal Optimization Strategies Evaluation AHF (ROSE AHF) trial randomized 360 patients with AHF and renal dysfunction receiving intravenous diuretic to dopamine, nesiritide, or placebo. Sodium concentration was measured in cumulative urine sample collected during the first 24 hours after randomization in 298 patients. Based on prior studies, lower U Na  was defined as ≤60 mmol/L.
RESULTS


Lower U Na  was present in 142 (48%) patients, who had longer LOS (7 days vs 5 days, P < .001) and less 72-hour weight loss (5.7 lb vs 9.0 lb, P < .001). These associations persisted after controlling for baseline estimated glomerular filtration rate and outpatient furosemide dose. Lower U Na  did not modify the null effects of dopamine or nesiritide on clinical outcomes. Results were similar for spot rather than cumulative 24-hour U Na  concentration.
CONCLUSION


In patients hospitalized for AHF and renal dysfunction, U Na   ≤ 60 mmol/L during the first 24 hours of diuresis identifies patients at risk for prolonged hospitalization but does not provide an indication for adjunctive dopamine or nesiritide.",2020,"Lower U Na  was present in 142 (48%) patients, who had longer LOS (7 days vs 5 days, P < .001) and less 72-hour weight loss (5.7 lb vs 9.0 lb, P < .001).","['360 patients with AHF and renal dysfunction receiving intravenous diuretic to', 'patients hospitalized with acute heart failure (AHF', 'acute heart failure patients', '298 patients']","['dopamine, nesiritide, or placebo', 'Renal Optimization Strategies Evaluation AHF (ROSE AHF']","['Lower U Na', '72-hour weight loss', 'Sodium concentration']","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",360.0,0.113408,"Lower U Na  was present in 142 (48%) patients, who had longer LOS (7 days vs 5 days, P < .001) and less 72-hour weight loss (5.7 lb vs 9.0 lb, P < .001).","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jie-Lena', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Finnian R', 'Initials': 'FR', 'LastName': 'Mc Causland', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Ly', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lynne W', 'Initials': 'LW', 'LastName': 'Stevenson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Neal K', 'Initials': 'NK', 'LastName': 'Lakdawala', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",Clinical cardiology,['10.1002/clc.23286']
316,32202830,The impact of primary care behavioral health services on patient behaviors: A randomized controlled trial.,"INTRODUCTION


Greater understanding of the impact of low intensity psychosocial interventions delivered by behavioral health clinicians (BHCs) working in an integrated care program (ICP) may promote better depression care.
METHOD


In a randomized controlled trial, 153 participants identified as depressed by their primary care provider (PCP) were assigned to ICP or usual care (UC, management by PCP, including specialty referral). In the ICP condition, BHCs worked collaboratively with PCPs and liaison psychiatrists.
RESULTS


ICP participants with lower and higher severity symptoms reported significantly greater use of coping strategies than UC participants at the 1-month follow up (lower: p = .002; higher: p = .016). ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups. ICP participants were more likely to be following relapse preventions plans at the 4-month follow up (lower: 89.5% vs. 50%, p = .0.000; higher 74.1% vs. 33%, p = .0001). ICP participants also reported use of antidepressant medications on more days than UC participants at the 4-month follow up (lower: 21.27 vs. 14.49 days, p = .049; higher: 24.61 vs. 17.08 days, p = .035). Patient retention in the ICP was high, and ICP participants were significantly more satisfied with depression care than UC participants at follow-up assessments.
DISCUSSION


Delivery of low intensity psychosocial interventions by BHCs was associated with improvements to behavior charge targets. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups.","['patient behaviors', '153 participants identified as depressed by their primary care provider (PCP']","['ICP or usual care (UC, management by PCP, including specialty referral', 'ICP', 'low intensity psychosocial interventions delivered by behavioral health clinicians (BHCs) working in an integrated care program (ICP', 'primary care behavioral health services']","['coping strategies', 'relapse preventions plans']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}]","[{'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]",153.0,0.0617056,"ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Robinson', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Von Korff', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Bush', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Elizabeth H B', 'Initials': 'EHB', 'LastName': 'Lin', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Evette J', 'Initials': 'EJ', 'LastName': 'Ludman', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000474']
317,31580094,Impact of a community-based intervention on Latino grandparents' knowledge about and self-efficacy in supporting grandchildren's physical activities.,"INTRODUCTION


Latino grandparents are often involved in rearing grandchildren, but their roles in promoting children's physical activity (PA) have been largely overlooked. This study examined the impact of a community-based intervention called Nietos Activos y Saludables (Active and Healthy Grandchildren) on Latino grandparents' knowledge about and self-efficacy in supporting grandchildren's (aged 2-12 years) PA.
METHOD


The Spanish language intervention, consisting of 4 weekly sessions, was delivered to 12 Latino grandparents (primarily female, aged > 60 years) in Los Angeles County from October to November 2017. Pre- and posttest surveys and postintervention focus groups assessed the intervention impact.
RESULTS


Participants indicated that the intervention provided useful information. After intervention sessions, participants achieved a higher score in test on PA requirements for children. They also reported greater knowledge about children's PA, local resources for children's PA, and modifying children's behavior. Additionally, participants reported greater confidence in motivating children in PA and collaborating with parents in promoting children's PA. Results of focus groups generally confirmed the quantitative findings.
DISCUSSION


Nietos Activos y Saludables intervention has the promise to increase Latino grandparents' knowledge about and self-efficacy in supporting grandchildren's PA. Future studies should test the impact of the intervention on grandparents' behavior and grandchildren's health outcomes using a randomized controlled trial. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Nietos Activos y Saludables intervention has the promise to increase Latino grandparents' knowledge about and self-efficacy in supporting grandchildren's PA.,"['12 Latino grandparents (primarily female, aged > 60 years) in Los Angeles County from October to November 2017', ""supporting grandchildren's (aged 2-12 years) PA""]","['community-based intervention called Nietos Activos y Saludables (Active and Healthy Grandchildren', 'community-based intervention']","[""Latino grandparents' knowledge about and self-efficacy""]","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0337471', 'cui_str': 'Grand-parent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0337548', 'cui_str': 'Grand child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0337548', 'cui_str': 'Grand child'}]","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0337471', 'cui_str': 'Grand-parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",2019.0,0.0234164,Nietos Activos y Saludables intervention has the promise to increase Latino grandparents' knowledge about and self-efficacy in supporting grandchildren's PA.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Recreation and Tourism Management.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Caldwell', 'Affiliation': 'Department of Recreation Park and Tourism Management.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Loy', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Aristizabal', 'Affiliation': 'Department of Health Sciences.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Guzman', 'Affiliation': 'Department of Health Sciences.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000443']
318,32295131,"Effects of a Psychological Management Program on Subjective Happiness, Anger Control Ability, and Gratitude among Late Adolescent Males in Korea.","This study aimed to develop an emotion management program for late adolescent males, and investigate the effect of the program. This study is an experimental study using a pretest-posttest control group design. It was conducted from 14 May to 21 December, 2018 at a male high school in Korea. It analyzed 52 participants (26 in the experimental group and 26 in the control group.) Regarding subjective happiness, there was a significant difference between groups (t = 3.409,  p  = 0.001). In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/ z = 0.528,  p  = 0.599). This program for emotion management, which is based on the broaden-and-build theory, can improve subjective happiness, anger control ability, and gratitude, by reinforcing appreciation skills and anger awareness and self-expression in male high school students.",2020,"In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/","['14 May to 21 December, 2018 at a male high school in Korea', 'late adolescent males', '52 participants (26 in the experimental group and 26 in the control group', 'male high school students', 'Late Adolescent Males in Korea']","['emotion management program', 'Psychological Management Program']","['Subjective Happiness, Anger Control Ability, and Gratitude', 'subjective happiness']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0120727,"In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/","[{'ForeName': 'Ju Eun', 'Initials': 'JE', 'LastName': 'Hong', 'Affiliation': 'Department of Nursing, Dongyang University, Yeongju 36040, Korea.'}, {'ForeName': 'Miok', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Nursing, Dankook University, Cheonan 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17082683']
319,31069935,Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart.,"AIMS


To investigate the pharmacokinetic/pharmacodynamic properties of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in people with type 2 diabetes (T2D).
MATERIALS AND METHODS


In a randomized, double-blind, crossover design, 61 people with T2D usually treated with insulin ± oral antidiabetic drug(s) received single-dose faster aspart and IAsp (0.3 U/kg) on separate visits. Blood samples for pharmacokinetic assessment were collected frequently until 12 hours post-dose. Glucose-lowering effect was determined in a euglycaemic clamp lasting up to 12 hours post-dose (target 5.0 mmol/L).
RESULTS


The serum IAsp pharmacokinetic profile and glucose-lowering effect profile were shifted to the left for faster aspart versus IAsp. Least squares mean (± SE) onset of appearance was 3.3 ± 0.3 minutes for faster aspart, which was 1.2 minutes earlier than for IAsp (95% confidence interval [CI] -1.8;-0.5; P = .001). Onset of action for faster aspart was 8.9 minutes earlier (95% CI -12.1;-5.7; P < .001) than for IAsp. During the first 30 minutes after dosing, 89% larger IAsp exposure (ratio faster aspart/IAsp 1.89 [95% CI 1.56;2.28]; P < .001) and 147% greater glucose-lowering effect (2.47 [95% CI 1.58;6.22]; P < .001) were observed for faster aspart compared with IAsp. Offset of exposure (time to 50% of maximum IAsp concentration in the late part of the pharmacokinetic profile) occurred earlier for faster aspart (difference faster aspart - IAsp -36.4 minutes [95% CI -55.3;-17.6]; P < .001). The treatment difference of faster aspart - IAsp in offset of glucose-lowering effect (time to 50% of maximum glucose infusion rate in the late part of the glucose infusion rate profile) was -14.4 minutes (95% CI -34.4;5.5; P = .152).
CONCLUSIONS


In people with T2D, faster aspart was associated with earlier onset and greater initial exposure and glucose-lowering effect compared with IAsp, as previously shown in people with type 1 diabetes.",2019,"In people with T2D, faster aspart was associated with earlier onset and greater initial exposure and glucose-lowering effect compared with IAsp, as previously shown in people with type 1 diabetes.","['people with type 2 diabetes (T2D', '61 people with T2D usually treated with insulin\u2009±\u2009oral antidiabetic drug(s) received', 'people with type 2 diabetes']","['insulin aspart', 'Fast-acting insulin aspart', 'single-dose faster aspart and IAsp', 'fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp']","['Glucose-lowering effect', 'glucose-lowering effect', 'Least squares mean (± SE) onset of appearance', 'serum IAsp pharmacokinetic profile and glucose-lowering effect profile']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",61.0,0.189697,"In people with T2D, faster aspart was associated with earlier onset and greater initial exposure and glucose-lowering effect compared with IAsp, as previously shown in people with type 1 diabetes.","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Svehlikova', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brunner', 'Affiliation': 'CF Clinical Research Center, Center for Medical Research, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Inge B', 'Initials': 'IB', 'LastName': 'Halberg', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Karen Margrete', 'Initials': 'KM', 'LastName': 'Due Thomsen', 'Affiliation': 'Novo Nordisk, Aalborg, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Haahr', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13767']
320,30987415,Intraperitoneal nebulization versus intraperitoneal instillation of ropivacaine for postoperative pain management following laparoscopic donor nephrectomy.,"BACKGROUND


Laparoscopic donor nephrectomy is considered less painful than open nephrectomy but is still associated with significant postoperative pain. Studies reported that intraperitoneal instillation of local anesthetics provides uncertain pain relief after laparoscopic surgery. This randomized, double-blind study evaluated the effect of intraperitoneal nebulization of ropivacaine on postoperative pain relief after laparoscopic donor nephrectomy.
METHODS


Sixty patients undergoing elective laparoscopic donor nephrectomy were randomly assigned to receive either an instillation of 20 ml 0.5% ropivacaine after the induction of pneumoperitoneum or nebulization of 5 ml 1% ropivacaine before and after surgery. The primary outcome was the degree of pain relief (static and dynamic) after surgery. The secondary outcomes were postoperative fentanyl consumption, incidence of shoulder pain, unassisted walking and postoperative nausea and vomiting (PONV). Data were collected in the postanesthesia care unit (PACU) and at 6, 24, and 48 h after surgery.
RESULTS


Compared to patients in the instillation group, those in the nebulization group showed significant reductions in postoperative pain and fentanyl consumption, and none complained of significant shoulder pain (visual analog scale score ≥ 30 mm). Within 20 h of surgery, 13.3% of patients in the instillation group and 93.3% in the nebulization group started unassisted walking (absolute risk reduction, 38%; P = 0.001). In the nebulization group, PONV was significantly reduced in the PACU and at 6 h.
CONCLUSIONS


Intraperitoneal nebulization of ropivacaine reduced postoperative pain, fentanyl consumption, referred shoulder pain, and PONV while enabling earlier mobility without any difference in the length of hospital stay.",2019,"Results


Significant reduction in postoperative pain and fentanyl consumption were noted in nebulization group and no patient complained of significant shoulder pain (VAS ≥ 30 mm) in comparison to patients in the instillation group.","['laparoscopic donor nephrectomy', 'after laparoscopic donor nephrectomy', '60 patients undergoing elective laparoscopic donor nephrectomy', 'after laparoscopic surgery']","['\n\n\nLaparoscopic donor nephrectomy', 'ropivacaine', 'ropivacaine 0.5%, 20 ml after induction of pneumoperitoneum or nebulization of ropivacaine', 'local anesthetic']","['postoperative pain and fentanyl consumption', 'shoulder pain', 'postoperative fentanyl requirement, the incidence of shoulder pain, postoperative nausea and vomiting', 'postoperative pain management', 'postoperative pain relief', 'degree of pain relief (static and dynamic', 'postoperative pain, fentanyl requirements, referred shoulder pain, PONV with earlier mobility', 'pain relief', 'duration of the hospital stay']","[{'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0198632', 'cui_str': 'Surgical pneumoperitoneum by injection (procedure)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",60.0,0.20129,"Results


Significant reduction in postoperative pain and fentanyl consumption were noted in nebulization group and no patient complained of significant shoulder pain (VAS ≥ 30 mm) in comparison to patients in the instillation group.","[{'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesiology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Soumya Shankar', 'Initials': 'SS', 'LastName': 'Nath', 'Affiliation': 'Department of Anesthesiology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]",Korean journal of anesthesiology,['10.4097/kja.d.18.00290']
321,31155682,Electroacupuncture for women with urgency-predominant mixed urinary incontinence: secondary analysis of a randomized noninferiority trial.,"OBJECTIVE


To compare the effects and safety of electroacupuncture (EA) and the integration of pelvic floor muscle training (PFMT) and solifenacin in women with urgency-predominant mixed urinary incontinence (MUI).
METHODS


The study was a secondary analysis of a randomized noninferiority trial which recruited 500 women with MUI and randomized 178 with urgency-predominant MUI to either receive 12-week EA treatment and 24-week follow-up or 36-week PFMT-solifenacin treatment. Clinical response was defined as at least 50% reduction in average 24-h urgency incontinence episode frequency (IEF), measured by 72-h voiding diary through weeks 1-12.
RESULTS


Of the patients randomized, 173 completed the study. The clinical response was 45.78% in EA group, similar with 50.0% in PFMT-solifenacin group, with a difference of - 3.54 (95% CI - 19.08 to 12.0; P = 0.66). In both groups, the proportion of patients with at least 50% reduction of IEF and stress IEF were improved, while the score of ICIQ-SF, episodes of urination, nocturia and urgency, 1-h amount of urinary leakage (AUL), proportion of patients using pads and the number consumed were all decreased after 12-week treatment. The effects could sustain till 36 weeks. Adverse events occurred less in EA group.
CONCLUSIONS


EA might reduce IEF, AUL and improve the life quality of female patients with urgency-predominant MUI. The effect may sustain till 36 weeks.",2020,"In both groups, the proportion of patients with at least 50% reduction of IEF and stress IEF were improved, while the score of ICIQ-SF, episodes of urination, nocturia and urgency, 1-h amount of urinary leakage (AUL), proportion of patients using pads and the number consumed were all decreased after 12-week treatment.","['female patients with urgency-predominant MUI', 'women with urgency-predominant mixed urinary incontinence', '500 women with MUI and randomized 178 with urgency-predominant MUI to either receive 12-week', 'women with urgency-predominant mixed urinary incontinence (MUI']","['pelvic floor muscle training (PFMT) and solifenacin', 'Electroacupuncture', 'PFMT-solifenacin', 'EA treatment and 24-week follow-up or 36-week PFMT-solifenacin treatment', 'electroacupuncture (EA']","['clinical response', 'Adverse events', 'score of ICIQ-SF, episodes of urination, nocturia and urgency, 1-h amount of urinary leakage (AUL), proportion of patients using pads and the number consumed', 'IEF and stress IEF', 'average 24-h urgency incontinence episode frequency (IEF', 'life quality', 'Clinical response']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034380'}]",500.0,0.10383,"In both groups, the proportion of patients with at least 50% reduction of IEF and stress IEF were improved, while the score of ICIQ-SF, episodes of urination, nocturia and urgency, 1-h amount of urinary leakage (AUL), proportion of patients using pads and the number consumed were all decreased after 12-week treatment.","[{'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Acupuncture, Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Sixing', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Acupuncture, Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture, Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China. zhishunjournal@163.com.""}]",World journal of urology,['10.1007/s00345-019-02828-1']
322,32294244,Periodontal regeneration by leukocyte and platelet-rich fibrin with autogenous bone graft versus enamel matrix derivative with autogenous bone graft in the treatment of periodontal intrabony defects: A randomized non-inferiority trial.,"BACKGROUND


Aim of the present study was to ascertain if a combination of leukocyte and platelet-rich fibrin (L-PRF) + autogenous bone graft (ABG) may be a clinically ""non-inferior"" treatment modality as compared with the association of enamel matrix derivative (EMD) with ABG in the management of intrabony defects (IBDs).
METHODS


A total of forty-four patients, exhibiting at least one unfavorable intraosseous defect, were treated by L-PRF associated with ABG (22 patients; test group) or EMD+ABG (control group) in each defect. At baseline and 12 months, a complete clinical and radiographic examination was done. Pre- and post-therapy clinical (probing pocket depth [PPD], clinical attachment level [CAL], gingival recession [GR]) and radiographic (defect Bone level [(DBL)] parameters for the different treatments were compared. To guarantee the test treatment's efficacy 1mm was chosen as non-inferiority margin; for clinical relevance, a second non-inferiority margin = 0.5 mm was set.
RESULTS


Clinical and radiographic parameters significantly improved 12 months after surgery in both test and control sites, without inter-groups differences for each measurement. The control group - test group differences for the parameters CAL gain -0.248 mm (-0.618 to 0.122), PPD Reduction -0.397 mm (-0.810 to 0.015), GR Change 0.059 mm (-0.300 to 0.418), DBL Gain -0.250 mm (-0.746 to 0.246) were all within the non-inferiority margin of 0.5 mm.
CONCLUSION


Our results suggest that the L-PRF+ABG combined treatment of non-contained IBDs produces non-inferior results in terms of CAL gain, PPD reduction, GR increase and DBL gain in comparison with the EMD+ABG combination.",2020,"RESULTS


Clinical and radiographic parameters significantly improved 12 months after surgery in both test and control sites, without inter-groups differences for each measurement.","['periodontal intrabony defects', 'Forty-four patients, exhibiting at least one unfavourable intraosseous defect, were treated by L-PRF associated with ABG (22 patients; test group) or EMD+ABG (control group) in each defect']","['Pre- and post-therapy', 'leukocyte and platelet-rich fibrin (L-PRF) + autogenous bone graft (ABG', 'autogenous bone graft versus enamel matrix derivative with autogenous bone graft']","['CAL gain, PPD reduction, GR increase and DBL gain', 'clinical (probing pocket depth [PPD], clinical attachment level [CAL], gingival recession [GR]) and radiographic (defect Bone level [(DBL)] parameters']","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0595613', 'cui_str': 'Intraosseous route'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",44.0,0.117386,"RESULTS


Clinical and radiographic parameters significantly improved 12 months after surgery in both test and control sites, without inter-groups differences for each measurement.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Paolantonio', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University, Chieti-Pescara, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Di Tullio', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University, Chieti-Pescara, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Giraudi', 'Affiliation': 'Department of Surgical Sciences, C.I.R. Dental School, University of Turin, Turin, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Romano', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University, Chieti-Pescara, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Secondi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University, Chieti-Pescara, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Paolantonio', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University, Chieti-Pescara, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Graziani', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, Sub-Unit of Periodontology, Halitosis and Periodontal Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pilloni', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Section of Periodontics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'De Ninis', 'Affiliation': '""Luisa D\'Annunzio"" Institute for High Culture, Pescara, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Femminella', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, ""G. D\'Annunzio"" University, Chieti-Pescara, Italy.'}]",Journal of periodontology,['10.1002/JPER.19-0533']
323,32203978,Effects of Interleukin-1β Inhibition on Incident Anemia: Exploratory Analyses From a Randomized Trial.,"Background


Inflammatory cytokines, such as interleukin (IL)-1β, alter iron homeostasis and erythropoiesis, resulting in anemia, but whether inhibition of IL-1β can reverse these effects is unclear.
Objective


To determine whether IL-1β inhibition with canakinumab reduces incident anemia and improves hemoglobin levels among those with prevalent anemia.
Design


Exploratory analysis of a randomized controlled trial. (ClinicalTrials.gov: NCT01327846).
Setting


Many clinical sites in 39 countries.
Participants


8683 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants without anemia at trial entry and 1303 with prevalent anemia at trial entry.
Intervention


Random assignment to receive placebo or canakinumab (50, 150, or 300 mg) subcutaneously once every 3 months.
Measurements


Primary outcome was incident anemia (hemoglobin level <130 g/L in men or <120 g/L in women).
Results


Anemia incidence increased with rising baseline levels of high-sensitivity C-reactive protein (hsCRP), and both hsCRP and IL-6 decreased among participants receiving canakinumab compared with the placebo group. During a median follow-up of 3.7 years, participants without baseline anemia who received canakinumab at any dosage had significantly less incident anemia than those who received placebo (hazard ratio, 0.84 [95% CI, 0.77 to 0.93]; P < 0.001). Compared with placebo, the greatest benefits of IL-1β inhibition on incident anemia were observed among participants with the most robust anti-inflammatory response, an effect corroborated in formal mediation analyses. Among those with baseline anemia, canakinumab increased mean hemoglobin levels by 11.3 g/L (P < 0.001) compared with placebo after 2 years of treatment. Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
Limitation


CANTOS was not designed to assess the cause of anemia in individual trial participants.
Conclusion


These exploratory analyses of randomized trial data provide proof of principle that inflammation inhibition, at least through the IL-1β/IL-6 signaling pathway, reduces the incidence of anemia and improves hemoglobin levels in patients with anemia.
Primary Funding Source


Novartis Pharmaceuticals.",2020,"Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
","['Participants\n\n\n8683 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants without anemia at trial entry and 1303 with prevalent anemia at trial entry', 'those with prevalent anemia', '39 countries', 'Incident Anemia', 'patients with anemia']","['Interleukin-1β Inhibition', 'placebo', 'placebo or canakinumab']","['mean hemoglobin levels', 'hsCRP and IL-6', 'hemoglobin levels', 'incident anemia', 'risk for infection', 'incident anemia (hemoglobin level', 'thrombocytopenia and neutropenia']","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C1265848', 'cui_str': 'Inflammatory thrombosis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",,0.720694,"Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
","[{'ForeName': 'Mounica', 'Initials': 'M', 'LastName': 'Vallurupalli', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey (T.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-2945']
324,32108442,Effect of Plain Versus Sugar-Sweetened Breakfast on Energy Balance and Metabolic Health: A Randomized Crossover Trial.,"OBJECTIVE


This study investigated the effect of 3 weeks of high-sugar (""Sweet"") versus low-sugar (""Plain"") breakfast on energy balance, metabolic health, and appetite.
METHODS


A total of 29 healthy adults (22 women) completed this randomized crossover study. Participants had pre- and postintervention appetite, health, and body mass outcomes measured, and they recorded diet, appetite (visual analogue scales), and physical activity for 8 days during each intervention. Interventions were 3 weeks of isoenergetic Sweet (30% by weight added sugar; average 32 g of sugar) versus Plain (no added sugar; average 8 g of sugar) porridge-based breakfasts.
RESULTS


Pre- to postintervention changes in body mass were similar between Plain (Δ 0.1 kg; 95% CI: -0.3 to 0.5 kg) and Sweet (Δ 0.2 kg; 95% CI: -0.2 to 0.5 kg), as were pre- to postintervention changes for biomarkers of health (all P ≥ 0.101) and psychological appetite (all P ≥ 0.152). Energy, fat, and protein intake was not statistically different between conditions. Total carbohydrate intake was higher during Sweet (287 ± 82 g/d vs. 256 ± 73 g/d; P = 0.009), driven more by higher sugar intake at breakfast (116 ± 46 g/d vs. 88 ± 38 g/d; P < 0.001) than post-breakfast sugar intake (Sweet 84 ± 42 g/d vs. Plain 80 ± 37 g/d; P = 0.552). Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
CONCLUSIONS


Energy balance, health markers, and appetite did not respond differently to 3 weeks of high- or low-sugar breakfasts.",2020,"Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
",['29 healthy adults (22 women'],"['Plain Versus Sugar-Sweetened Breakfast', 'isoenergetic Sweet (30% by weight added sugar', 'high-sugar (""Sweet"") versus low-sugar (""Plain"") breakfast', 'Plain (no added sugar; average 8 g of\xa0sugar) porridge-based breakfasts']","['body mass', 'reduced sweet desire', 'psychological appetite', 'Energy Balance and Metabolic Health', 'Energy, fat, and protein intake', 'diet, appetite (visual analogue scales), and physical activity', 'energy balance, metabolic health, and appetite', 'Total carbohydrate intake']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",29.0,0.323909,"Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
","[{'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Wharton', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, UK.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Trim', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Enhad A', 'Initials': 'EA', 'LastName': 'Chowdhury', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Brunstrom', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'School for Policy Studies, University of Bristol, Bristol, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22757']
325,31187203,Combined androgen blockade (CAB) versus luteinizing hormone-releasing hormone (LHRH) agonist monotherapy for androgen deprivation therapy.,"PURPOSE


Combined androgen blockade (CAB) and luteinizing hormone-releasing hormone (LHRH) agonist monotherapy are commonly used in androgen deprivation therapy (ADT). In this randomized clinical trial, we aimed to compare the two methods of ADT in terms of quality of life (QOL).
METHODS


Eighty patients who underwent primary ADT for newly diagnosed prostate cancer were randomly assigned to CAB group (Group 1) and LHRH agonist monotherapy group (Group 2). Leuprolide and anti-androgen (bicalutamide 50 mg) were used to minimize the confounding effects caused by medication. QOL was evaluated at baseline, 3 months and 6 months post-ADT using validated EORTC QLQ-C30, PR25, and depression questionnaires. A difference of > 10 points in the EORTC domain scores was defined as 'clinically significant'.
RESULTS


In the baseline characteristics, there was no significant difference between the two groups. At 3 months after ADT, Group 1 had significantly lower pain scores than Group 2 (p = 0.004), while Group 1 had significantly poorer diarrhea symptom score than Group 2, without clinical significance (p = 0.047). No significant differences were observed in the C30, PR25 domains, and the depression score at 3 months. At 6 months, the QOL scores of all the groups were similar.
CONCLUSIONS


There was no difference in the patient's QOL, except that CAB group was associated with significantly better pain relief than LHRH agonist monotherapy at 3 months following ADT, which was not sustained thereafter. Our results suggest that the benefit of prolonged (≥ 3 months) CAB is questionable in terms of patients' QOL.",2020,"At 3 months after ADT, Group 1 had significantly lower pain scores than Group 2 (p = 0.004), while Group 1 had significantly poorer diarrhea symptom score than Group 2, without clinical significance (p = 0.047).",['Eighty patients who underwent primary ADT for newly diagnosed prostate cancer'],"['CAB', 'androgen blockade (CAB) and luteinizing hormone-releasing hormone (LHRH) agonist monotherapy', 'LHRH agonist monotherapy', 'Combined androgen blockade (CAB) versus luteinizing hormone-releasing hormone (LHRH) agonist monotherapy', 'Leuprolide and anti-androgen (bicalutamide', 'ADT']","['QOL', 'diarrhea symptom score', 'pain scores', 'validated EORTC QLQ-C30, PR25, and depression questionnaires', 'C30, PR25 domains, and the depression score', 'quality of life (QOL', 'QOL scores', 'pain relief']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3495882', 'cui_str': 'Combined androgen blockade'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C3540699', 'cui_str': 'Anti-androgen hormone antagonists and related agents'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0034380'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",80.0,0.116835,"At 3 months after ADT, Group 1 had significantly lower pain scores than Group 2 (p = 0.004), while Group 1 had significantly poorer diarrhea symptom score than Group 2, without clinical significance (p = 0.047).","[{'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Eulji University Hospital, Eulji University School of Medicine, 95 Dunsanseoro, Seo-gu, Daejeon, 35233, South Korea.'}, {'ForeName': 'Hyun Bin', 'Initials': 'HB', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, Eulji University Hospital, Eulji University School of Medicine, 95 Dunsanseoro, Seo-gu, Daejeon, 35233, South Korea.'}, {'ForeName': 'Seung Hyo', 'Initials': 'SH', 'LastName': 'Woo', 'Affiliation': 'Department of Urology, Eulji University Hospital, Eulji University School of Medicine, 95 Dunsanseoro, Seo-gu, Daejeon, 35233, South Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Jeon', 'Affiliation': 'Department of Urology, Kyung Hee University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Hyub', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Kyung Hee University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Ho', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Department of Urology, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Shim', 'Affiliation': 'Department of Urology, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Wook', 'Initials': 'DW', 'LastName': 'Shin', 'Affiliation': 'Department of Family Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Eulji University Hospital, Eulji University School of Medicine, 95 Dunsanseoro, Seo-gu, Daejeon, 35233, South Korea. jspark.uro@gmail.com.'}]",World journal of urology,['10.1007/s00345-019-02847-y']
326,30520980,"Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial.","Aims


Bioresorbable scaffolds (BRS) provide short-term coronary artery scaffolding and drug delivery. Although prior trials showed a higher rate of device failure compared with conventional drug-eluting stents (DES), only a single trial investigated patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). We aimed to compare outcomes with BRS vs. DES in patients undergoing PCI for MI.
Methods and results


We did a prospective, randomized, multicentre, non-inferiority, clinical trial of everolimus-eluting BRS vs. durable polymer everolimus-eluting stents (EES) in patients with acute MI. Patients were eligible for enrolment if they presented with ST-elevation MI, or non-ST-elevation MI with thrombosis visual at angiography and were randomly allocated to treatment with BRS or EES in 2:1 proportion. Angiographic follow-up was scheduled at 6-8 months and clinical follow-up was done at 12 months. The primary endpoint was percentage diameter stenosis in-segment at follow-up. A total of 262 patients were enrolled and were allocated to BRS (n = 173) or EES (n = 89). Angiographic follow-up was available for 213 (81.3%) patients. Mean diameter stenosis was 24.6 ± 12.2% with BRS vs. 27.3 ± 11.7% with EES (mean difference -2.7%, upper limit of one-sided 97.5% confidence limit 0.7%, pre-specified margin of non-inferiority 5%, Pnon-inferiority <0.001). The rate of the device-oriented composite of cardiac death/target vessel MI/target lesion revascularization [BRS: 12 (7.0%) vs. EES: 6 (6.7%), hazard ratio (HR) 1.04, 95% confidence interval (CI) 0.39-2.78] and definite/probable stent thrombosis [3 (1.7%) vs. 2 (2.3%), HR 0.76, 95% CI 0.13-4.56] were comparable in both groups.
Conclusion


In patients undergoing PCI for acute MI BRS were non-inferior to EES for percentage diameter stenosis at angiographic follow-up. Rates of clinical events were comparable between the treatment groups, although the study was not powered to detect differences in clinical outcomes.
Clinical trial registration


The trial was registered at www.clinicaltrials.gov (NCT01942070).",2019,In patients undergoing PCI for acute MI BRS were non-inferior to EES for percentage diameter stenosis at angiographic follow-up.,"['patients undergoing PCI for MI', 'patients with acute MI', 'Patients were eligible for enrolment if they presented with ST-elevation MI, or non-ST-elevation MI with thrombosis visual at angiography', 'patients undergoing PCI for acute MI BRS', 'patients undergoing coronary stenting for myocardial infarction', 'A total of 262 patients']","['EES', 'bioresorbable scaffolds vs. everolimus-eluting stents', 'BRS or EES', 'BRS', 'percutaneous coronary intervention (PCI', 'conventional drug-eluting stents (DES', 'everolimus-eluting BRS vs. durable polymer everolimus-eluting stents (EES', 'BRS vs. DES']","['percentage diameter stenosis', 'definite/probable stent thrombosis', 'hazard ratio (HR', 'Mean diameter stenosis', 'rate of device failure', 'Rates of clinical events', 'rate of the device-oriented composite of cardiac death/target vessel MI/target lesion revascularization [BRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086138', 'cui_str': 'Device Failure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",262.0,0.207523,In patients undergoing PCI for acute MI BRS were non-inferior to EES for percentage diameter stenosis at angiographic follow-up.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': 'Department of Cardiovascular Diseases, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Cardiac Department, Hospital Universitario de La Princesa Madrid, Madrid, Spain.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Clinic and Policlinic Internal Medicine I (Cardiology and Angiology), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': 'Department of Cardiovascular Diseases, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kretov', 'Affiliation': 'E.N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bradaric', 'Affiliation': 'Clinic and Policlinic Internal Medicine I (Cardiology and Angiology), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Rai', 'Affiliation': 'Department of Cardiovascular Diseases, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cuesta', 'Affiliation': 'Cardiac Department, Hospital Universitario de La Princesa Madrid, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivero', 'Affiliation': 'Cardiac Department, Hospital Universitario de La Princesa Madrid, Madrid, Spain.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hoppmann', 'Affiliation': 'Clinic and Policlinic Internal Medicine I (Cardiology and Angiology), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schlichtenmaier', 'Affiliation': 'Clinic and Policlinic Internal Medicine I (Cardiology and Angiology), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Evald H', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Department of Cardiovascular Diseases, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Department of Cardiovascular Diseases, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Department of Cardiovascular Diseases, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Department of Cardiovascular Diseases, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehy710']
327,32113924,"Ambulatory Oxygen in Fibrotic Interstitial Lung Disease: A Pilot, Randomized, Triple-Blinded, Sham-Controlled Trial.","BACKGROUND


Despite a lack of evidence, ambulatory oxygen therapy is frequently prescribed for patients with interstitial lung disease (ILD) and exertional desaturation. Patients often prefer portable oxygen concentrators to oxygen cylinders. This study aimed to examine the feasibility of conducting a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD.
RESEARCH QUESTION


Is it feasible to conduct a clinical trial of ambulatory oxygen delivered via portable concentrators in patients with ILD?
STUDY DESIGN AND METHODS


In this randomized, triple-blinded, sham-controlled trial, 30 participants with ILD and isolated exertional desaturation to < 90% on 6-minute walk tests were randomized to 12-week ambulatory oxygen or air delivered via portable concentrators, with assessments performed at baseline and weeks 4, 12, and 18. Primary outcomes were trial feasibility and the change in 6-minute walk distance (6MWD) on room air at week 12.
RESULTS


Study recruitment was completed within 18 months, with six withdrawals. Participant blinding was successful, with the Bang's Blinding Index being 0 (95% CI, -0.40 to 0.40) for the oxygen group and 0 (95% CI, -0.42 to 0.42) for the sham group. No significant difference in 6MWD was seen between groups at week 12 (mean difference of -34 m [95% CI, -105 to 36], P = .34). For secondary outcomes, compared with the sham group, the oxygen group had a significantly higher Leicester Cough Questionnaire psychological domain score, indicating better cough-related quality of life (mean difference of 0.9 [95% CI, 0.2 to 1.6], P = .01), but a shorter duration of moderate-to-vigorous activities (mean difference of -135 [95% CI, -267 to -3], P = .04) at week 12.
INTERPRETATION


Based on the results of this pilot study, a definitive randomized controlled trial with a longer intervention duration is warranted to clarify therapeutic impacts of ambulatory oxygen in patients with ILD.
TRIAL REGISTRY


Australian New Zealand Clinical Trials Registry; No.: ACTRN12617000054314; URL: www.anzctr.org.au/.",2020,"There was no significant difference in 6MWD between groups at Week 12 (mean difference of -34m [95% CI: -105, 36], p = 0.34).","['fibrotic ILD', 'patients with ILD', '30 participants with ILD and isolated exertional desaturation to <90% on 6-minute walk tests', 'patients with interstitial lung disease (ILD) and exertional desaturation']","['ambulatory oxygen therapy', 'ambulatory oxygen or air delivered via portable concentrators', 'portable oxygen concentrators to oxygen cylinders', 'ambulatory oxygen delivered via portable concentrators']","['Leicester Cough Questionnaire psychological domain score', 'shorter duration of moderate-to-vigorous activities', 'cough-related quality of life', 'trial feasibility and the change in 6-minute walk distance (6MWD) on room air at Week 12', '6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1618343', 'cui_str': 'Portable oxygen concentrator (physical object)'}, {'cui': 'C0182124', 'cui_str': 'Oxygen cylinder (physical object)'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",30.0,0.571943,"There was no significant difference in 6MWD between groups at Week 12 (mean difference of -34m [95% CI: -105, 36], p = 0.34).","[{'ForeName': 'Yet H', 'Initials': 'YH', 'LastName': 'Khor', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; School of Medicine, University of Melbourne, Melbourne, Victoria, Australia; Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia. Electronic address: yethong.khor@austin.org.au.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; Department of Physiotherapy, Alfred Health and Monash University, Melbourne, Australia.'}, {'ForeName': 'Nicole S L', 'Initials': 'NSL', 'LastName': 'Goh', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Miller', 'Affiliation': 'Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Vlahos', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Bozinovski', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Aroub', 'Initials': 'A', 'LastName': 'Lahham', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Glaspole', 'Affiliation': 'Department of Respiratory Medicine, Alfred Health, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia; Institute for Breathing and Sleep, Heidelberg, Victoria, Australia; School of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}]",Chest,['10.1016/j.chest.2020.01.049']
328,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN


Parallel-group, quasi-experimental study.
OBJECTIVES


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


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


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


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


The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2']
329,31612956,Cannabis and Alcohol Co-Use in a Smoking Cessation Pharmacotherapy Trial for Adolescents and Emerging Adults.,"INTRODUCTION


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


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


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


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


Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation.",2020,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","['youth cigarette smokers', 'Adolescents and Emerging Adults', 'smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White']","['varenicline', 'cannabis or alcohol co-use', 'Varenicline']",['cigarette smoking'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",,0.0318818,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz170']
330,31942688,Weight Loss and Vomiting 1 Year After Banded Versus Non-banded One Anastomosis Gastric Bypass: a Prospective Randomized Trial.,"BACKGROUND


The weight loss outcomes after banded one-anastomosis gastric bypass (OAGB) remain to be determined.
OBJECTIVE


To compare weight loss and vomiting 1 year after banded versus non-banded OAGB.
METHODS


This is a prospective, open-label, randomized study, which evaluated 33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12 months. Weight loss (percentages of total weight loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting were assessed and compared before surgery and after 6 and 12 months.
RESULTS


At baseline, there were no differences between groups in regard to age, gender, and body mass index (BMI). At 6 and 12 months post-op, and the overall mean %TWL regardless of band use was 22.4 ± 7% and 29 ± 6.9%, respectively, and the overall average %EWL regardless of band use was 66.8 ± 22.9% and 86.3 ± 24%, respectively. %TWL did not differ between the banded and non-banded groups at 6 (21.8 ± 6.8% vs. 23.1 ± 7.4%; p = 0.7) and 12 months post-op (27.5 ± 6.6% vs. 30.4 ± 7.1%; p = 0.3), as well as %EWL at 6 (67 ± 22.9% vs. 67.6 ± 23.6%; p = 0.6) and 12 months post-op (83.5 ± 24.4% vs. 89 ± 24.1%; p = 0.4). The occurrence of vomiting did not significantly differ between banded and non-banded OAGB at 6 (12.5% vs. 11.8%; p = 0.9) and 12 months post-op (12.5% vs. 5.9%; p = 0.5).
CONCLUSION


OAGB led to an overall satisfactory weight loss after 1 year, regardless of band use. Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.",2020,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"['33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12\xa0months']","['OAGB', 'Banded Versus Non-banded One Anastomosis Gastric Bypass']","['weight loss and vomiting 1\xa0year', 'overall satisfactory weight loss', 'weight loss nor more vomiting', 'Weight Loss and Vomiting 1 Year', 'occurrence of vomiting', 'Weight loss (percentages of total weight', 'loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0252491,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"[{'ForeName': 'Everton', 'Initials': 'E', 'LastName': 'Cazzo', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil. notrevezzo@yahoo.com.'}, {'ForeName': 'Laísa Simakawa', 'Initials': 'LS', 'LastName': 'Jimenez', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Gilberto', 'Initials': 'FG', 'LastName': 'Valerini', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Tiago Bezerra', 'Initials': 'TB', 'LastName': 'de Freitas Diniz', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Elinton Adami', 'Initials': 'EA', 'LastName': 'Chaim', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04393-8']
331,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND


Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC).
OBJECTIVE


Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC.
METHODS


A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain.
RESULTS


Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
CONCLUSION


Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6']
332,32291275,"Continuous Positive Airway Pressure Treatment, Glycemia, and Diabetes Risk in Obstructive Sleep Apnea and Comorbid Cardiovascular Disease.","OBJECTIVE


Despite evidence of a relationship among obstructive sleep apnea (OSA), metabolic dysregulation, and diabetes, it is uncertain whether OSA treatment can improve metabolic parameters. We sought to determine effects of long-term continuous positive airway pressure (CPAP) treatment on glycemic control and diabetes risk in patients with cardiovascular disease (CVD) and OSA.
RESEARCH DESIGN AND METHODS


Blood, medical history, and personal data were collected in a substudy of 888 participants in the Sleep Apnea cardioVascular Endpoints (SAVE) trial in which patients with OSA and stable CVD were randomized to receive CPAP plus usual care, or usual care alone. Serum glucose and glycated hemoglobin A 1c  (HbA 1c ) were measured at baseline, 6 months, and 2 and 4 years and incident diabetes diagnoses recorded.
RESULTS


Median follow-up was 4.3 years. In those with preexisting diabetes ( n  = 274), there was no significant difference between the CPAP and usual care groups in serum glucose, HbA 1c , or antidiabetic medications during follow-up. There were also no significant between-group differences in participants with prediabetes ( n  = 452) or new diagnoses of diabetes. Interaction testing suggested that women with diabetes did poorly in the usual care group, while their counterparts on CPAP therapy remained stable.
CONCLUSIONS


Among patients with established CVD and OSA, we found no evidence that CPAP therapy over several years affects glycemic control in those with diabetes or prediabetes or diabetes risk over standard-of-care treatment. The potential differential effect according to sex deserves further investigation.",2020,"In those with preexisting diabetes ( n  = 274), there was no significant difference between the CPAP and usual care groups in serum glucose, HbA 1c , or antidiabetic medications during follow-up.","['women with diabetes', 'Blood, medical history, and personal data were collected in a substudy of 888 participants in the Sleep Apnea Cardiovascular End Points (SAVE) trial in which patients with OSA and stable CVD', 'patients with established CVD and OSA', 'patients with cardiovascular disease (CVD']","['CPAP plus usual care, or usual care alone', 'CPAP therapy', 'long-term continuous positive airway pressure (CPAP) treatment']","['serum glucose, HbA 1c , or antidiabetic medications', 'Serum glucose and glycated hemoglobin', 'Continuous Positive Airway Pressure Treatment, Glycemia, and Diabetes Risk in Obstructive Sleep Apnea and Comorbid Cardiovascular Disease', 'glycemic control and diabetes risk']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0443211', 'cui_str': 'Established'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",888.0,0.0162083,"In those with preexisting diabetes ( n  = 274), there was no significant difference between the CPAP and usual care groups in serum glucose, HbA 1c , or antidiabetic medications during follow-up.","[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Loffler', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia kelly.loffler@flinders.edu.au doug.mcevoy@flinders.edu.au.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Heeley', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Freed', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Meng', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lia R', 'Initials': 'LR', 'LastName': 'Bittencourt', 'Affiliation': 'Instituto do Sono, Associação Fundo de Incentivo a Pesquisa, São Paulo, Brazil.'}, {'ForeName': 'Carolina C', 'Initials': 'CC', 'LastName': 'Gonzaga Carvalho', 'Affiliation': 'Sleep Laboratory, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hlavac', 'Affiliation': 'Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Fuwai Hospital, Beijing, China.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Sleep Laboratory, Pulmonary Division, Instituto do Coração, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Yuanming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, Guangzhou, Guangdong, China.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'McArdle', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Department of Pulmonary Physiology and Sleep Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Sutapa', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Hooi Shan', 'Initials': 'HS', 'LastName': 'Yap', 'Affiliation': 'Sleep Health Service, Respiratory and Sleep Services, Southern Adelaide Local Health Network, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Xilong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lyle J', 'Initials': 'LJ', 'LastName': 'Palmer', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia kelly.loffler@flinders.edu.au doug.mcevoy@flinders.edu.au.'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2006']
333,31957922,"OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single-dose treatment from a phase III, randomized, double-blind, placebo-controlled trial (interim analysis).","OBJECTIVE


To evaluate the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) 100 U in patients with overactive bladder and urinary incontinence.
METHODS


This was a phase III, randomized, double-blind, placebo-controlled trial in Japanese patients who were inadequately managed with overactive bladder medications (anticholinergics and/or β 3  -adrenergic receptor agonists). Eligible patients were randomized 1:1 to receive a single dose of either onabotulinumtoxinA or placebo into the detrusor muscle (n = 124 each). The primary end-point was the change in the number of daily urinary incontinence episodes at week 12 from baseline. Secondary end-points included volume voided per micturition, other symptomatic measures (urinary urgency incontinence, micturition, urgency and nocturia) and patient-reported outcomes.
RESULTS


In the onabotulinumtoxinA group, there was a significantly greater decrease from baseline in the mean number of daily urinary incontinence episodes compared with the placebo group (2.16; P < 0.001), and significantly greater improvement for all secondary end-points (P < 0.05). Urinary tract infection, dysuria, urinary retention and post-void residual urine volume increased represented adverse events occurring at a higher rate in the onabotulinumtoxinA group. The majority of these were mild or moderate in severity.
CONCLUSIONS


Statistically significant and clinically relevant improvements in symptoms and patient-reported outcomes, and tolerability were seen in patients with overactive bladder and urinary incontinence who had been inadequately managed with overactive bladder medications after using onabotulinumtoxinA.",2020,"Urinary tract infection, dysuria, urinary retention and post-void residual urine volume increased represented adverse events occurring at a higher rate in the onabotulinumtoxinA group.","['Japanese patients with overactive bladder and urinary incontinence', 'patients with overactive bladder and urinary incontinence', 'patients with overactive bladder and urinary incontinence\xa0who had been\xa0inadequately managed with overactive bladder medications after using onabotulinumtoxinA', 'Japanese patients who were inadequately managed with overactive bladder medications (anticholinergics and/or β 3  -adrenergic receptor agonists', 'Eligible patients']","['placebo', 'onabotulinumtoxinA or placebo', 'OnabotulinumtoxinA (botulinum toxin type\xa0A', 'onabotulinumtoxinA (botulinum toxin type A']","['Urinary tract infection, dysuria, urinary retention and post-void residual urine volume', 'mean number of daily urinary incontinence episodes', 'tolerability', 'volume voided per micturition, other symptomatic measures (urinary urgency incontinence, micturition, urgency and nocturia) and patient-reported outcomes', 'number of daily urinary incontinence episodes']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C4521957', 'cui_str': 'Adrenergic receptor agonist (disposition)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.486782,"Urinary tract infection, dysuria, urinary retention and post-void residual urine volume increased represented adverse events occurring at a higher rate in the onabotulinumtoxinA group.","[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Honda', 'Affiliation': 'Department of Urology, Tottori University Faculty of Medicine, Tottori, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Urology, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sekiguchi', 'Affiliation': ""Yokohama Motomachi Women's Clinic LUNA, Kanagawa, Japan.""}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Medicines Development, Japan Development Division, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline, Tokyo, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Mogi', 'Affiliation': 'Medicines Development, Japan Development Division, GlaxoSmithKline, Tokyo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14176']
334,32122921,Genomic Variants of Cytarabine Sensitivity Associated with Treatment-Related Mortality in Pediatric AML: A Report from the Children's Oncology Group.,"PURPOSE


Cytarabine is an effective treatment for AML with associated toxicities including treatment related mortality (TRM). The purpose is to determine the clinical relevance of SNPs identified through the use of HapMap lymphoblastoid cell-based models, in predicting cytarabine response and toxicity in AML.
EXPERIMENTAL DESIGN


We tested clinical significance of SNPs associated with cytarabine sensitivity in children with AML treated on Children's Oncology Group regimens (CCG 2941/2961). Endpoints included overall survival (OS), event-free survival (EFS), and TRM. Patients who received bone marrow transplant were excluded. We tested 124 SNPs associated with cytarabine sensitivity in HapMap cell lines in 348 children to determine whether any associated with treatment outcomes. In addition, we tested five SNPs previously associated with TRM in children with AML in our independent dataset of 385 children.
RESULTS


Homozygous variant genotypes of rs2025501 and rs6661575 had increased  in vitro  cellular sensitivity to cytarabine and were associated with increased TRM. TRM was particularly increased in children with variant genotype randomized to high-dose cytarabine (rs2025501:  P  = 0.0024 and rs6661575  P  = 0.0188). In analysis of previously reported SNPs, only the variant genotype rs17202778 C/C was significantly associated with TRM ( P  < 0.0001).
CONCLUSIONS


We report clinical importance of two SNPs not previously associated with cytarabine toxicity. Moreover, we confirm that SNP rs17202778 significantly impacts TRM in pediatric AML. Cytarabine sensitivity genotypes may predict TRM and could be used to stratify to standard versus high-dose cytarabine regimens, warranting further study in prospective AML trials.",2020,"RESULTS


Homozygous variant genotypes of rs2025501 and rs6661575 had increased  in vitro  cellular sensitivity to cytarabine and were associated with increased TRM.","[""children with AML treated on Children's Oncology Group regimens (CCG 2941/2961"", '348 children', 'pediatric AML', 'Patients who received bone marrow transplant were excluded']","['cytarabine', 'Cytarabine']","['TRM', 'cytarabine toxicity', 'overall survival (OS), event free survival (EFS) and TRM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",385.0,0.0445535,"RESULTS


Homozygous variant genotypes of rs2025501 and rs6661575 had increased  in vitro  cellular sensitivity to cytarabine and were associated with increased TRM.","[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio. Christine.phillips@cchmc.org.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""Division of Biostatics and Epidemiology, Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Gerbing', 'Affiliation': ""Children's Oncology Group, Arcadia, California.""}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Alonzo', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Alyss', 'Initials': 'A', 'LastName': 'Wilkey', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital, Cincinnati Ohio.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Radloff', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital, Cincinnati Ohio.""}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Lange', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Gamazon', 'Affiliation': 'Vanderbilt Genetics Institute and the Division of Genetic Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'M Eileen', 'Initials': 'ME', 'LastName': 'Dolan', 'Affiliation': 'Section of Hematology/Oncology, The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Davies', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3117']
335,32291291,Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services.,"OBJECTIVES


Common mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms.
METHODS


Randomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee's manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health.
RESULTS


A statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
CONCLUSION


PSI was effective in reducing sickness absence which was the primary outcome in this study.",2020,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
","['100 employees with stress symptoms or CMDs', 'Randomisation was conducted at the OHS consultant level and each consultant was allocated into either', 'employees with common mental disorders or stress-related symptoms at work', 'employees with CMDs or stress-related symptoms', 'Common mental disorders (CMDs']","['CAU', 'giving a brief problem-solving intervention (PSI) or care as usual (CAU']","['earlier partial RTW and the mental health', 'sickness absence', 'self-registered sickness absence, return to work (RTW) and mental health', 'registered sickness absence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028801', 'cui_str': 'Occupational health service'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",100.0,0.155075,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
","[{'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Keus van de Poll', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden marijke.keus.van.de.poll@ki.se.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Nybergh', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lornudd', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hagberg', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Bodin', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kwak', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Lohela-Karlsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Torgén', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Bergstrom', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106353']
336,32265361,"Early Progression and Immune Reconstitution Inflammatory Syndrome During Treatment of Mild-To-Moderate Kaposi Sarcoma in Sub-Saharan Africa and South America: Incidence, Long-Term Outcomes, and Effects of Early Chemotherapy.","BACKGROUND


Early progression of AIDS-associated Kaposi sarcoma (KS-PD) and immune reconstitution inflammatory syndrome (KS-IRIS) sometimes occur after the initiation of antiretroviral therapy (ART).
METHODS


Early KS-PD and KS-IRIS were assessed in the A5264/AMC-067 trial in which participants with mild-to-moderate AIDS-KS were randomized to initiate ART with either immediate or as-needed oral etoposide. Early KS-PD was defined as tumor progression within 12 weeks of ART initiation. When investigators had concern that early KS-PD was KS-IRIS, additional evaluations were performed. Suspected KS-IRIS was defined as early KS-PD accompanied by a CD4 count increase of ≥50 cells per cubic millimeter or plasma HIV-1 RNA decrease of ≥0.5 log10 copies/mL. Clinical outcome was a composite end point categorized as failure, stable, and response at 48 and 96 weeks compared with baseline.
RESULTS


Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS and 22 were not evaluated for KS-IRIS. Early KS-PD and KS-IRIS incidences with immediate etoposide versus ART alone were 16% versus 39%, and 7% versus 21%, respectively. Week 48 clinical outcome was 45% failure, 18% stable, and 37% response for no early KS-PD; 82% failure, 2% stable, and 16% response for early KS-PD; and 88% failure, 0% stable, and 12% response for KS-IRIS. Cumulative incidence of KS tumor response by week 96 was 64% for no early KS-PD, 22% with early KS-PD, and 18% with KS-IRIS.
CONCLUSIONS


Early KS-PD, including suspected KS-IRIS, was common after starting ART for AIDS-KS and was associated with worse long-term clinical outcomes. Starting ART concurrently with etoposide reduced the incidence of both early KS-PD and KS-IRIS compared with ART alone.",2020,Week 48 clinical outcome was 45%,"['mild-to-moderate Kaposi sarcoma in sub-Saharan Africa and South America', 'Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS, 22 were not evaluated for KS-IRIS', 'participants with mild-to-moderate AIDS-KS']","['immediate etoposide', 'early chemotherapy', 'etoposide']","['incidence of both early KS-PD and KS-IRIS', 'Early KS-PD and KS-IRIS incidences', 'Early KS-PD and KS-IRIS', 'Cumulative incidence of KS tumor response', 'plasma HIV-1']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0036220', 'cui_str': ""Kaposi's sarcoma""}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",,0.10907,Week 48 clinical outcome was 45%,"[{'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'McNeil', 'Initials': 'M', 'LastName': 'Ngongondo', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Umbleja', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Krown', 'Affiliation': 'AIDS Malignancy Consortium, New York, NY.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International Clinical Research Site, Enhancing Care Foundation, Durban, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Hoagland', 'Affiliation': 'Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Frontier Science Foundation, Amherst, New York, NY.'}, {'ForeName': 'Oto', 'Initials': 'O', 'LastName': 'Martinez-Maza', 'Affiliation': 'Department of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, CA.'}, {'ForeName': 'Dirk P', 'Initials': 'DP', 'LastName': 'Dittmer', 'Affiliation': 'Department of Microbiology & Immunology, University of North Carolina School of Medicine, and Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Borok', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002361']
337,32108686,Prophylactic Intrathecal Morphine and Prevention of Post-Dural Puncture Headache: A Randomized Double-blind Trial.,"BACKGROUND


Prophylactic epidural morphine administration after unintentional dural puncture with a large-bore needle has been shown to decrease the incidence of post-dural puncture headache. The authors hypothesized that prophylactic administration of intrathecal morphine would decrease the incidence of post-dural puncture headache and/or need for epidural blood patch after unintentional dural puncture.
METHODS


Parturients with an intrathecal catheter in situ after unintentional dural puncture with a 17-g Tuohy needle during intended epidural catheter placement for labor analgesia were enrolled in this randomized, double-blind trial. After delivery, subjects were randomized to receive intrathecal morphine 150 µg or normal saline. The primary outcome was the incidence of post-dural puncture headache. Secondary outcomes included onset, duration, and severity of post-dural puncture headache, the presence of cranial nerve symptoms and the type of treatment the patient received.
RESULTS


Sixty-one women were included in the study. The incidence of post-dural puncture headache was 21 of 27 (78%) in the intrathecal morphine group and 27 of 34 (79%) in the intrathecal saline group (difference, -1%; 95% CI, -25% to 24%). There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms. Epidural blood patch was administered to 10 of 27 (37%) of subjects in the intrathecal morphine and 11 of 21 (52%) of the intrathecal saline group (difference 15%; 95% CI, -18% to 48%).
CONCLUSIONS


The present findings suggest that a single prophylactic intrathecal morphine dose of 150 µg administered shortly after delivery does not decrease the incidence or severity of post-dural puncture headache after unintentional dural puncture. This study does not support the clinical usefulness of prophylactic intrathecal morphine after an unintentional dural puncture.",2020,"There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms.","['unintentional dural puncture', 'Sixty-one women were included in the study', 'Post-Dural Puncture Headache', 'Parturients with an intrathecal catheter in situ after unintentional dural puncture with a 17-g Tuohy needle during intended epidural catheter placement for labor analgesia']","['prophylactic intrathecal morphine', 'intrathecal morphine', 'intrathecal saline', 'Epidural morphine', 'intrathecal morphine 150 µg or normal saline', 'Prophylactic Intrathecal Morphine']","['onset, duration, or severity of headache, or presence of cranial nerve symptoms', 'incidence or severity of post-dural puncture headache', 'onset, duration, and severity of post-dural puncture headache, the presence of cranial nerve symptoms and the type of treatment the patient received', 'Epidural blood patch', 'incidence of post-dural puncture headache']","[{'cui': 'C0919916', 'cui_str': 'Unintentional dural puncture'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C2584606', 'cui_str': 'Intrathecal catheter'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0184186', 'cui_str': 'Tuohy epidural needle'}, {'cui': 'C3665866', 'cui_str': 'Epidural catheter placement'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0010268', 'cui_str': 'Cranial Nerves'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162649', 'cui_str': 'Patchs, Epidural Blood'}]",61.0,0.677125,"There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms.","[{'ForeName': 'Feyce M', 'Initials': 'FM', 'LastName': 'Peralta', 'Affiliation': 'From the Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (F.M.P., N.H., P.T., M.J.J.) Department of Anesthesia, University of Iowa Carver College of Medicine, Iowa City, Iowa (C.A.W.) Department of Anesthesiology, Rush University Medical Center, Chicago, Illinois (R.J.M.).'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Toledo', 'Affiliation': ''}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'McCarthy', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003206']
338,32180131,Citicoline and Vitamin B 12  Eye Drops in Type 1 Diabetes: Results of a 3-year Pilot Study Evaluating Morpho-Functional Retinal Changes.,"INTRODUCTION


This study aimed to evaluate the effect of treatment with eye drops containing citicoline and vitamin B 12  on changes in function of the inner retina, morphology of the inner and outer retina, and microvascular condition in patients with type 1 diabetes (DM1) with mild signs of non-proliferative diabetic retinopathy (NPDR) during 3 years of follow-up.
METHODS


A pilot study with prospective, randomized, and double-masked design was conducted to address the aims. Twenty patients with DM1 were enrolled and randomly divided into two groups: the DC group comprising patients treated with citicoline and vitamin B 12  eye drops (10 patients; mean age ± standard deviation, 46.86 ± 8.78 years) and the DP group comprising those treated with placebo (10 patients; mean age ± standard deviation, 47.89 ± 7.74 years). In the DC group, one eye of each patient was treated with citicoline and vitamin B 12  eye drops (OMK2 ® , Omikron Italia srl, Italy, 3 drops/day), while in the DP group, it was treated with placebo (eye drops containing hypromellose 0.3%, 3 drops/day) for a 3-year period. In both groups, Humphrey Matrix frequency doubling technology (FDT), spectral domain optical coherence tomography (SD-OCT) and OCT angiography (OCTA), and adaptive optics (AO) were applied at baseline and 12, 24, and 36 months of the follow-up period.
RESULTS


In the results of follow-up evaluation, the DC and DP groups were significantly different: Significant reduction in function in terms of 10-2 FDT mean sensitivity and in morphology reflected by an increase in inner nuclear layer thickness and decrease in other plexiform layer thickness and foveal vessel density were observed in the DP group, while no such significant changes were observed in the DC group in the long term.
CONCLUSIONS


This pilot study indicated that patients with DM1 with mild signs of diabetic retinopathy (DR) who underwent treatment with citicoline and vitamin B 12  eye drops for a 3-year duration achieved stabilization or decreased rate of functional impairment, neuroretinal degeneration, and microvascular damage.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT04009980.",2020,"In the results of follow-up evaluation, the DC and DP groups were significantly different: Significant reduction in function in terms of 10-2 FDT mean sensitivity and in morphology reflected by an increase in inner nuclear layer thickness and decrease in other plexiform layer thickness and foveal vessel density were observed in the DP group, while no such significant changes were observed in the DC group in the long term.
","['patients with type\xa01 diabetes (DM1) with mild signs of non-proliferative diabetic retinopathy (NPDR) during 3\xa0years of follow-up', 'Type\xa01 Diabetes', 'Twenty patients with DM1', 'patients with DM1 with mild signs of diabetic retinopathy (DR) who underwent treatment with']","['eye drops containing citicoline and vitamin\xa0B 12', 'Citicoline and Vitamin\xa0B 12  Eye Drops', 'placebo', 'citicoline and vitamin\xa0B 12  eye drops (OMK2 ® , Omikron Italia srl', 'DC group comprising patients treated with citicoline and vitamin\xa0B 12  eye drops', 'citicoline and vitamin\xa0B 12  eye drops']","['function of the inner retina, morphology of the inner and outer retina, and microvascular condition', 'rate of functional impairment, neuroretinal degeneration, and microvascular damage', 'plexiform layer thickness and foveal vessel density', 'Humphrey Matrix frequency doubling technology (FDT), spectral domain optical coherence tomography (SD-OCT) and OCT angiography (OCTA), and adaptive optics (AO', 'inner nuclear layer thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0004606', 'cui_str': 'NPDR - Non proliferative diabetic retinopathy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0450207', 'cui_str': 'Plexiform (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",20.0,0.112857,"In the results of follow-up evaluation, the DC and DP groups were significantly different: Significant reduction in function in terms of 10-2 FDT mean sensitivity and in morphology reflected by an increase in inner nuclear layer thickness and decrease in other plexiform layer thickness and foveal vessel density were observed in the DP group, while no such significant changes were observed in the DC group in the long term.
","[{'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Parravano', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Scarinci', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy. fabio.scarinci@fondazionebietti.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Parisi', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Giorno', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Giannini', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Oddone', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Varano', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01284-3']
339,32290490,Health-Related Physical Fitness Benefits in Sedentary Women Employees after an Exercise Intervention with Zumba Fitness ® .,"Background : The protective properties of high physical fitness levels on health are manifest independently of age, sex, fatness, smoking, alcohol consumption, and other clinical factors. However, women are less active than men, which contributes to low physical fitness and a high risk of CVD. Thus, the objective of this study is to analyze the effect of two exercise interventions on health-related physical fitness in sedentary employed females.  Methods : A total of 98 physically inactive adult women were randomly assigned to 3 study groups: the control group (CG) = 31, the endurance training group based on Zumba Fitness ®  classes (ET;  n  = 39), and the concurrent training group that had an extra muscle-strengthening workout after the Zumba Fitness ®  class (CnT;  n  = 28). Body composition (BMI, waist circumference), motor fitness (one-leg stand test), musculoskeletal fitness (shoulder-neck mobility, handgrip strength test, jump and reach test, and dynamic sit-up test), and cardiorespiratory fitness (2-km test and estimated VO 2  max) were assessed with the ALPHA-Fit test battery for adults.  Results : Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  p  = 0.02, CnT = -2.550 ± 1.13,  p =  0.03; one-stand leg test: ET = 13.532 ± 2.65,  p  < 0.001; CnT = 11.656 ± 2.88,  p  < 0.001; shoulder-neck mobility: ET = 1.757 ± 0.44,  p  < 0.001, CnT = 2.123 ± 0.47,  p  < 0.001; handgrip test: 0.274 ± 0.08,  p  < 0.001, CnT = 0.352 ± 0.08,  p  < 0.001; dynamic sit-up: ET = 1.769 ± 0.45,  p  < 0.001, CnT = -1.836 ± 0.49,  p  < 0.001; 2-km test time: -1.280 ± 0.25,  p  < 0.001, CnT = -1.808 ± 0.28,  p  < 0.001; estimated VO 2  max: ET = 1.306 ± 0.13,  p  < 0.001, CnT = 1.191 ± 0.15,  p  < 0.001). There were no significant differences after the intervention between the two exercise intervention groups.  Conclusions : Exercise interventions based on Zumba fitness ®  or Zumba fitness ®  combined with an extra muscle-strengthening workout based on bodyweight training exercises are effective strategies to improve the health-related physical fitness in sedentary women employees.",2020,"Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  ","['sedentary employed females', '98 physically inactive adult women', 'sedentary women employees', 'Sedentary Women Employees']","['exercise interventions', 'extra muscle-strengthening workout based on bodyweight training exercises', 'control group (CG) = 31, the endurance training group based on Zumba Fitness ®  classes (ET;  n  = 39), and the concurrent training group that had an extra muscle-strengthening workout after the Zumba Fitness ®  class (CnT']","['majority of health-related fitness and body composition variables', 'health-related physical fitness', 'ALPHA-Fit test battery for adults', 'Body composition (BMI, waist circumference), motor fitness (one-leg stand test), musculoskeletal fitness (shoulder-neck mobility, handgrip strength test, jump and reach test, and dynamic sit-up test), and cardiorespiratory fitness (2-km test and estimated VO 2  max']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",98.0,0.0334706,"Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  ","[{'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla 52071, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla 52071, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082632']
340,32293706,Exploring occupancy of the histamine H 3  receptor by pitolisant in humans using PET.,"BACKGROUND AND PURPOSE


BF2.649 (pitolisant, Wakix®) is a novel histamine H 3  receptor inverse agonist/antagonist recently approved for the treatment of narcolepsy disorder. The objective of the study was to investigate in vivo occupancy of H 3  receptors by BF2.649 using PET brain imaging with the H 3  receptor antagonist radioligand [ 11  C]GSK189254.
EXPERIMENTAL APPROACH


Six healthy adult participants were scanned with [ 11  C]GSK189254. Participants underwent a total of two PET scans on separate days, 3 h after oral administration of placebo or after pitolisant hydrochloride (40 mg). [ 11  C]GSK189254 regional total distribution volumes were estimated in nine brain regions of interest with the two tissue-compartment model with arterial input function using a common V ND  across the regions. Brain receptor occupancies were calculated with the Lassen plot.
KEY RESULTS


Pitolisant, at the dose administered, provided high (84 ± 7%; mean ± SD) occupancy of H 3  receptors. The drug was well-tolerated, and participants experienced few adverse events.
CONCLUSION AND IMPLICATIONS


The administration of pitolisant (40 mg) produces a high occupancy of H 3  receptors and may be a new tool for the treatment of a variety of CNS disorders that are associated with mechanisms involving H 3  receptors.",2020,Pitolisant 40 mg promoted 84±7% (x̅±SD) occupancy of H3R.,"['Humans Using Positron Emission Tomography', 'Six healthy adult participants']",['placebo or after pitolisant hydrochloride'],"['vivo H3R occupancy', 'Brain receptor occupancies']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}]","[{'cui': 'C0062739', 'cui_str': 'Histamine H3 Receptor'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",6.0,0.0585618,Pitolisant 40 mg promoted 84±7% (x̅±SD) occupancy of H3R.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rusjan', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Sabioni', 'Affiliation': 'Translational Addiction Research Laboratory, CAMH, Toronto, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Di Ciano', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Mansouri', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boileau', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Laveillé', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Capet', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Duvauchelle', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet Biotech, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'Bioprojet Biotech, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}]",British journal of pharmacology,['10.1111/bph.15067']
341,32287168,Advances in Hereditary Angioedema: The Prevention of Angioedema Attacks With Subcutaneous C1-Inhibitor Replacement Therapy.,"Hereditary angioedema (HAE) is a debilitating condition caused by a functional C1-inhibitor (C1-INH) deficiency and characterized clinically by episodes of subcutaneous or submucosal swelling. C1-INH replacement is highly effective for preventing HAE attacks and can improve health-related quality of life. Once available only for intravenous use, C1-INH is now available as a subcutaneous formulation for self-administration, shown to provide sustained plasma levels of C1-INH and reducing the monthly median HAE attack rate by 95% versus placebo in the phase 3 COMPACT study. Subcutaneously administered C1-INH satisfies multiple unmet needs in the management of patients with HAE.",2020,C1-INH replacement is highly effective for preventing HAE attacks and can improve health-related quality of life.,"['Hereditary Angioedema', 'patients with HAE']","['C1-INH replacement', 'placebo', 'Subcutaneous C1-Inhibitor Replacement Therapy']","['median HAE attack rate', 'health-related quality of life']","[{'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0192333,C1-INH replacement is highly effective for preventing HAE attacks and can improve health-related quality of life.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lumry', 'Affiliation': 'AARA Research Center, Dallas, Texas (Dr Lumry); US HAEA Angioedema Center at University of California San Diego, San Diego, California (Ms Templeton); CSL Behring, King of Prussia, Pennsylvania (Dr Omert); University of California Irvine School of Medicine, Orange, California (Dr Levy). William Lumry, MD, is in private practice in Dallas, Texas, treating adults and children with allergic diseases and asthma. He actively participates in clinical research projects involving new treatments for asthma, allergic and immune deficiency diseases, and hereditary angioedema in his role as medical director of AARA Research Center. He is also clinical professor of internal medicine at the University of Texas Southwestern Medical School in Dallas and teaches at Parkland Memorial Hospital in Dallas. Dr Lumry is president of the Texas Allergy, Asthma and Immunology Society and a fellow of the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology, and the American College of Physicians. He is also a member of the US Hereditary Angioedema Association Medical Advisory Board on the panels responsible for the Hereditary Angioedema International Working Group, International Consensus, and World Allergy Organization hereditary angioedema consensus documents. Teri Templeton, LVN, was the nurse navigator and senior nurse supervisor of the US HAEA Angioedema Center at University of California San Diego, where she also served as the lead nurse on all clinical and translational research. As a public speaker and nurse educator, and through service on advisory boards, she worked to reduce the time to diagnosis and bring awareness to health care professionals on the signs and symptoms of hereditary angioedema. Laurel Omert, MD, is currently chief medical officer at Hemanext in Lexington, Massachusetts, and a staff surgeon and intensivist at Albert Einstein Medical Center in Philadelphia. She served as medical director at CSL Behring for specialty products that included C1-INH(SC) and C1-INH(IV) during the development of this manuscript. Donald Levy, MD, is a professor of medicine at University of California Irvine School of Medicine in Orange, California. He is very active in teaching students, residents, and fellows. He has a special interest in hereditary angioedema and conducts research in this field.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Templeton', 'Affiliation': ''}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Omert', 'Affiliation': ''}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': ''}]",Journal of infusion nursing : the official publication of the Infusion Nurses Society,['10.1097/NAN.0000000000000365']
342,32152869,Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS.,"INTRODUCTION


This pre-specified subgroup analysis evaluated the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) triple therapy versus corresponding dual therapies in the China subgroup of the phase III, double-blind KRONOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
METHODS


Patients were randomized 2:2:1:1 to BGF MDI 320/18/9.6 μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 μg twice daily for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) over weeks 12-24. Secondary endpoints included symptoms, health-related quality of life, and safety. Rate of moderate/severe COPD exacerbations was an additional efficacy endpoint.
RESULTS


In the China subgroup (n = 432; 22.7% of the KRONOS population), BGF MDI demonstrated nominally significant improvements in the primary endpoint versus BFF MDI (least squares mean (LSM) difference 68 mL; P = 0.0035) and BUD/FORM DPI (LSM difference 78 mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316). BGF MDI demonstrated at least numerical improvements versus comparators in secondary lung function and symptom endpoints. BGF MDI reduced the rate of moderate/severe COPD exacerbations versus GFF MDI (rate ratio 0.41; P = 0.0030), with numerical benefits versus BFF MDI and BUD/FORM DPI. All treatments were well tolerated.
CONCLUSIONS


Results demonstrated that BGF MDI showed benefits on lung function (vs inhaled corticosteroid/long-acting β 2 -agonist), as well as symptoms and exacerbations relative to dual therapies. Findings support BGF MDI use in Chinese patients with moderate to very severe COPD.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT02497001.",2020,mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316).,"['Chinese patients with moderate to very severe COPD', 'Chinese Patients with COPD', 'Patients were randomized 2:2:1:1 to BGF MDI 320/18/9.6', 'patients with moderate to very severe chronic obstructive pulmonary disease (COPD']","['glycopyrrolate/formoterol fumarate (GFF', 'Budesonide/Glycopyrrolate/Formoterol Fumarate', 'budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) triple therapy', 'BGF MDI', 'budesonide/formoterol fumarate (BFF) MDI']","['rate of moderate/severe COPD exacerbations versus GFF MDI', 'change from baseline in morning pre-dose trough forced expiratory volume', 'Efficacy and Safety', 'symptoms, health-related quality of life, and safety', 'tolerated', 'efficacy and safety', 'lung function', 'Rate of moderate/severe COPD exacerbations', 'BFF MDI (least squares mean (LSM) difference', 'BUD/FORM DPI']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'formoterol fumarate'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1276807', 'cui_str': 'Budesonide / formoterol'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.534037,mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316).,"[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing, 100029, China. cyh-birm@263.net.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Huijie', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China.'}, {'ForeName': 'Pryseley N', 'Initials': 'PN', 'LastName': 'Assam', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Su', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bourne', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'Formerly of AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01266-5']
343,32290880,Using fundraising incentives and point-of-purchase nutrition promotion to improve food choices among school families in restaurants: a pilot and feasibility study.,"OBJECTIVE


To assess the feasibility and efficacy of in-restaurant interventions aiming to promote healthy choices via fundraising incentives benefiting school wellness programmes and point-of-purchase nutrition promotion.
DESIGN


Twelve schools were randomly assigned to one of the two intervention periods: Fundraising Incentive (FI) donated funds for visiting the study restaurant and Fundraising-Healthy Eating Incentive (F-HEI) included FI with additional funds given when selecting a healthier item. Both conditions included point-of-purchase nutrition promotions. Families were recruited to attend their designated intervention and complete a survey. Feasibility was assessed based on recruitment and participation, implementation fidelity and intervention acceptability. Efficacy was assessed by comparing participant receipts between intervention periods and by comparing overall restaurant sales during intervention v. two no-intervention time frames.
SETTING


Fast-casual restaurant in Southern California.
PARTICIPANTS


Parents with children attending participating schools.
RESULTS


Eighty-one families visited the restaurant during the intervention, with sixty-six completing surveys. All study activities were implemented successfully, but school family participation in the intervention was low (0·95 %). Among participants completing surveys, all indicated satisfaction with the programme. The percentage of healthier items ordered was significantly greater during both FI (χ2 = 5·97, P = 0·01) and F-HEI (χ2 = 8·84, P = 0·003) v. Comparison 2. Results were similar but did not reach statistical significance when comparing the interventions to Comparison 1.
CONCLUSIONS


Results support potential efficacy of this programme, but more research is needed to inform feasibility. Fidelity and acceptability data supported feasibility, but participation rates were low in this initial study. Methods evaluating this intervention with a greater proportion of parents should be considered.",2020,"The percentage of healthier items ordered was significantly greater during both FI (χ2 = 5·97, P = 0·01) and F-HEI (χ2 = 8·84, P = 0·003) v. Comparison 2.","['Eighty-one families visited the restaurant during the intervention, with sixty-six completing surveys', 'Fast-casual restaurant in Southern California', 'Parents with children attending participating schools', 'school families in restaurants', 'Twelve schools']","['restaurant interventions', 'fundraising incentives and point-of-purchase nutrition promotion', 'Fundraising Incentive (FI) donated funds for visiting the study restaurant and Fundraising-Healthy Eating Incentive (F-HEI) included FI with additional funds given when selecting a healthier item']","['percentage of healthier items ordered', 'Efficacy', 'recruitment and participation, implementation fidelity and intervention acceptability']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0016816', 'cui_str': 'Fund Raising'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",81.0,0.0238933,"The percentage of healthier items ordered was significantly greater during both FI (χ2 = 5·97, P = 0·01) and F-HEI (χ2 = 8·84, P = 0·003) v. Comparison 2.","[{'ForeName': 'Shawna L', 'Initials': 'SL', 'LastName': 'McNally', 'Affiliation': 'Department of Research, Accents on Health, Inc. (dba Healthy Dining), San Diego, CA92123, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Anzman-Frasca', 'Affiliation': 'Department of Pediatrics, University at Buffalo, Buffalo, NY14214, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Bowman', 'Affiliation': 'Virginia Department of Education, James Monroe Building, Richmond, VA23219, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Beleche', 'Affiliation': 'Department of Research, Accents on Health, Inc. (dba Healthy Dining), San Diego, CA92123, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA02111, USA.'}, {'ForeName': 'Anjali A', 'Initials': 'AA', 'LastName': 'Patel', 'Affiliation': 'Department of Research, Accents on Health, Inc. (dba Healthy Dining), San Diego, CA92123, USA.'}]",Public health nutrition,['10.1017/S1368980019004609']
344,32229173,Perioperative non-invasive haemodynamic optimisation using photoplethysmography: A randomised controlled trial and meta-analysis.,"BACKGROUND


The present study aimed at evaluating the effect of a haemodynamic algorithm using SV maximisation by non-invasive photoplethysmography (interventional group) on the incidence of postoperative complications compared with a control group using intermittent mean arterial pressure.
METHODS


The non-blinded parallel-group trial randomised low-risk patients undergoing colorectal surgery into either interventional group or control group. The primary outcome was the incidence of patients with at least one complication during the 30 days following surgery. The secondary outcomes were the total number of complications, the length of hospital stay and postoperative mortality. A meta-analysis of randomised trials comparing perioperative haemodynamic optimisation (interventional group) using photoplethysmography with control group was performed to assess the external validity.
RESULTS


Among 160 randomised patients, 159 were analysed (80 and 79 in interventional and control groups, respectively). Demographic characteristics were similar in both groups. Postoperative complications occurred in 40 (50%) and 34 (43%) patients in the interventional and control groups, respectively (P=0.471). There were no significant differences between the two groups regarding the total number of complications (P=0.078), the hospital length of stay (P=0.960), or postoperative mortality (P=1.000). In the meta-analysis including 1089 patients in 7 randomised controlled studies, 203 (38%) and 221 (40%) patients suffered from at least one complication following surgery [risk ratio 0.89 (95% CI 0.68-1.17), P=0.407] in interventional and control groups, respectively.
CONCLUSIONS


Based on the findings of the present study and meta-analysis, a haemodynamic perioperative algorithm using SV maximisation by non-invasive photoplethysmography cannot reduce postoperative morbidity.",2020,"There were no significant differences between the two groups regarding the total number of complications (P = 0.078), the hospital length of stay (P = 0.960), or postoperative mortality (P = 1,000).","['160 patients randomised, 159 were analysed (80 and 79 in interventional and control groups, respectively', 'risk patients undergoing colorectal surgery into either interventional group or control group']","['Perioperative non-invasive haemodynamic optimisation using photoplethysmography', 'haemodynamic algorithm using SV maximisation by non-invasive photoplethysmography (interventional group']","['Postoperative complications', 'incidence of patients with at least one complication', 'Demographic characteristics', 'postoperative morbidity', 'postoperative complications', 'total number of complications', 'total number of complications, the length of hospital stay and postoperative mortality', 'hospital length of stay', 'postoperative mortality']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0162599', 'cui_str': 'Light Reflection Rheography'}, {'cui': 'C0002045'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.201676,"There were no significant differences between the two groups regarding the total number of complications (P = 0.078), the hospital length of stay (P = 0.960), or postoperative mortality (P = 1,000).","[{'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France. Electronic address: marcolivierfischer@yahoo.fr.""}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Fiant', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Debroczi', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Pasqualini', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Demonchy', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Flais', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Alves', 'Affiliation': 'UNICAEN, service de chirurgie digestive, Normandie université, CHU de Caen Normandie, 14000 Caen, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Gérard', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Buléon', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.03.016']
345,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B  receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z']
346,32185729,"New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study.","INTRODUCTION


To evaluate the effects of a new lubricating, antioxidant solution (VisuEvo ® ) on dry eye disease (DED) in patients undergoing cataract surgery.
METHODS


Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT > 7, Schirmer I test > 15 mm/5 min) were enrolled in this multicenter, open-label, randomized, prospective study. Scheduled visits were 2 weeks before surgery (screening), day of surgery (V0), week 1 (V1), and 2 (V2) after surgery. VisuEvo ®  was self-administered three times daily for the whole study duration (group A); the control group (group B) had no tear substitute administration. The primary endpoint was the change in TBUT over time; the secondary endpoints were changes in Ocular Surface Disease Index (OSDI), ocular surface staining, the Schirmer I test, and osmometry.
RESULTS


A total of 45 patients were included (group A, 23; group B, 22; age 74 ± 8 years). At the screening, TBUT was similar between the groups (group A, 8.5 ± 1.8 s; group B, 7.8 ± 0.7, p = 0.11). At the scheduled visits, TBUT increase vs screening visit was significantly higher in group A: +1.2 s at V0, +1.4 s at V1, and +1.9 s at V2 (p < 0.01). Also, OSDI was significantly lower in group A at V0, V1, and V2 (p < 0.027). After surgery, corneal staining was absent in 65-78% of group A compared with 54-59% in group B. The two groups did not show any significant differences of osmometry and the Schirmer I test.
CONCLUSIONS


The ocular surface was more protected and quickly restored from surgery when VisuEvo ®  was used from 2 weeks preoperatively to 2 weeks postoperatively.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03833908.",2020,The two groups did not show any significant differences of osmometry and the Schirmer,"['patients undergoing cataract surgery', '45 patients were included (group A, 23; group B, 22; age 74\u2009±\u20098\xa0years', 'Cataract Surgery', 'Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT >\u20097, Schirmer']","['new lubricating, antioxidant solution (VisuEvo ® ']","['corneal staining', 'OSDI', 'dry eye disease (DED', 'Ocular Surface Disease Index (OSDI), ocular surface staining, the Schirmer I test, and osmometry', 'change in TBUT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C3179117', 'cui_str': 'Osmometry'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",45.0,0.0361402,The two groups did not show any significant differences of osmometry and the Schirmer,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fogagnolo', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy. paolo.fogagnolo@unimi.it.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Favuzza', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Marchina', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Cennamo', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Vignapiano', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Quisisana', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Mencucci', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01288-z']
347,32286894,Effects of Cacao By-Products and a Modest Weight Loss Intervention on the Concentration of Serum Triglycerides in Overweight Subjects: Proof of Concept.,"Therapeutic approaches to decrease serum triglyceride (TG) concentrations are not successful mainly due to poor adherence or adverse effects of therapies. In consequence, the search for new low-cost and safer therapeutic alternatives is mandatory. Dark chocolate and cacao have shown promising results improving lipid profiles. Recently, using cacao by-products to reduce elevated cardiometabolic risk markers in an animal model of obesity induced by a high-fat diet and fructose, we showed that TGs, low-density lipoprotein cholesterol, and the TG/high-density lipoprotein (HDL) ratio decreased, suggesting that cacao by-products improved the metabolic function of obese animals. Based on these results, as a proof of concept, a blinded placebo-controlled study was implemented to explore the effects of cacao by-products on anthropometric and biochemical variables in a group of overweight subjects participating in a program composed of reduced-calorie-diet counseling plus a simple aerobic exercise plan. The results showed that counseling induced weight and abdominal circumference reductions in both groups. TGs did not change in the control group; however, TG decreased significantly by 54.9 mg/dL (27.9%) in the experimental group. The TG/HDL cholesterol ratio changed markedly (1.5) in the experimental group. The results reported suggest the use of cacao by-products as an alternative for the treatment of hypertriglyceridemia.",2020,"TGs did not change in the control group; however, TG decreased significantly by 54.9 mg/dL (27.9%) in the experimental group.","['Overweight Subjects', 'overweight subjects participating in a program composed of']","['Cacao By-Products and a Modest Weight Loss Intervention', 'reduced-calorie-diet counseling plus a simple aerobic exercise plan']","['elevated cardiometabolic risk markers', 'weight and abdominal circumference reductions', 'Concentration of Serum Triglycerides', 'serum triglyceride (TG) concentrations', 'TGs, low-density lipoprotein cholesterol, and the TG/high-density lipoprotein (HDL) ratio', 'TG', 'TG/HDL cholesterol ratio', 'lipid profiles']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.0224022,"TGs did not change in the control group; however, TG decreased significantly by 54.9 mg/dL (27.9%) in the experimental group.","[{'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'León-Flores', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Nayelli', 'Initials': 'N', 'LastName': 'Nájera', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pérez', 'Affiliation': 'Unit of Metabolism and Nutritional Support, Hospital Juarez, Mexico City, Mexico.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Pardo', 'Affiliation': 'Unit of Metabolism and Nutritional Support, Hospital Juarez, Mexico City, Mexico.'}, {'ForeName': 'Fiacro', 'Initials': 'F', 'LastName': 'Jimenez', 'Affiliation': 'Health Norms Direction, ISSSTE, Mexico City, Mexico.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Diaz-Chiguer', 'Affiliation': 'Health Norms Direction, ISSSTE, Mexico City, Mexico.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Villarreal', 'Affiliation': 'School of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hidalgo', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ceballos', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Meaney', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2019.0201']
348,32157626,Evaluation of Nurse Preferences Between the Lanreotide Autogel New Syringe and the Octreotide Long-Acting Release Syringe: An International Simulated-Use Study (PRESTO).,"INTRODUCTION


Somatostatin analogues are used to treat symptoms and slow tumour progression in patients with neuroendocrine tumours (NETs) and carcinoid syndrome and to reduce hormone secretion and pituitary tumour volume in patients with acromegaly. A new syringe for lanreotide autogel/depot (LAN) was developed following feedback from a human factors study to improve ease of injection compared with previous syringes. PRESTO aimed to assess preferences of nurses between the LAN new syringe and the octreotide long-acting release (LAR) syringe.
METHODS


PRESTO, a multinational, multicentre, prospective, noninterventional, simulated-use study, enrolled nurses with ≥ 2 years' experience injecting LAN and/or octreotide LAR in patients with NETs and/or acromegaly. Nurses administered injections into pads using the LAN new syringe and octreotide LAR syringe in a randomised sequence. In an anonymous web-based questionnaire, nurses reported their overall preference ('strong' or 'slight'; primary endpoint) and rated and ranked the importance of nine attributes for each syringe (1 [not at all] to 5 [very much]).
RESULTS


Overall, 90 nurses attended sessions and completed valid questionnaires. Most nurses (97.8%) expressed a preference (85.6% 'strong', 12.2% 'slight') for the LAN new syringe versus the octreotide LAR syringe (P < 0.0001). Attribute performance ratings (1 [not at all] to 5 [very much]) were consistently higher for the LAN new syringe versus the octreotide LAR syringe, with the greatest differences in 'fast administration' and 'confidence the syringe will not be clogged' (mean difference [SD]: 2.6 [1.2] and 2.3 [1.5], respectively; P < 0.0001). The attribute ranked most important was 'confidence the syringe will not be clogged' (24.4%); least important was 'convenience of syringe format, including packaging, from preparation to injection' (34.4%).
CONCLUSIONS


Nurses preferred the user experience of the LAN new syringe compared with the octreotide LAR syringe, with a particular preference for attributes related to product delivery with the LAN new syringe.",2020,"The attribute ranked most important was 'confidence the syringe will not be clogged' (24.4%); least important was 'convenience of syringe format, including packaging, from preparation to injection' (34.4%).
","['enrolled nurses with\u2009≥', 'patients with NETs and/or acromegaly', 'patients with neuroendocrine tumours (NETs) and carcinoid syndrome']","['lanreotide autogel/depot (LAN', 'octreotide LAR syringe', 'octreotide LAR', 'Lanreotide Autogel New Syringe and the Octreotide Long-Acting Release Syringe', 'octreotide long-acting release (LAR) syringe', 'LAN']",['Attribute performance ratings'],"[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001206', 'cui_str': 'Somatotropin Hypersecretion Syndrome (Acromegaly)'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0024586', 'cui_str': 'Malignant Carcinoid Syndrome'}]","[{'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}]",90.0,0.0348636,"The attribute ranked most important was 'confidence the syringe will not be clogged' (24.4%); least important was 'convenience of syringe format, including packaging, from preparation to injection' (34.4%).
","[{'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Adelman', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. d-adelman@northwestern.edu.'}, {'ForeName': 'Xuan-Mai', 'Initials': 'XM', 'LastName': 'Truong Thanh', 'Affiliation': 'Global Medical Affairs, Ipsen, Boulogne-Billancourt, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Feuilly', 'Affiliation': 'Health Economics and Outcomes Research, Ipsen, Boulogne-Billancourt, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Houchard', 'Affiliation': 'Biometry, Ipsen, Boulogne-Billancourt, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Advances in therapy,['10.1007/s12325-020-01255-8']
349,32166538,Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2.,"INTRODUCTION


New open-angle glaucoma (OAG) and ocular hypertension (OHT) therapies that reduce treatment burden and improve outcomes relative to currently available agents are needed. Netarsudil, a novel Rho kinase inhibitor approved by the US Food and Drug Administration, reduces intraocular pressure (IOP) by increasing trabecular outflow. Two phase 3 superiority studies compared a fixed-dose combination (FDC) of netarsudil and the prostaglandin latanoprost with each active component for IOP-lowering efficacy.
METHODS


Pooled efficacy and safety data were analyzed from MERCURY-1 and -2 studies in patients with OAG or OHT. Patients instilled one drop of netarsudil (0.02%)/latanoprost (0.005%) FDC (n = 483), netarsudil (0.02%, n = 499), or latanoprost (0.005%, n = 486) into each eye once-daily between 20:00 and 22:00. IOP was measured at 08:00, 10:00, and 16:00 at weeks 2, 6, and the primary endpoint at month 3.
RESULTS


Baseline mean diurnal IOP was 23.6, 23.6, and 23.5 mmHg in netarsudil/latanoprost FDC, netarsudil, and latanoprost groups, respectively. Mean diurnal IOP in each group was 15.3, 18.1, and 17.5 mmHg at week 2, 15.7, 18.4, and 17.4 mmHg at week 6, and 15.8, 18.4, and 17.3 mmHg at week 12. The netarsudil/latanoprost FDC met criteria for superiority compared with each active component (p < 0.0001 for all nine time points). At month 3, among patients randomized to netarsudil/latanoprost FDC or latanoprost, 58.4% vs 37.3% (p < 0.0001) achieved IOP ≤ 16 mmHg. Among patients randomized to netarsudil/latanoprost FDC or netarsudil or latanoprost, 30.9% vs 5.9% (p < 0.0001) vs 8.5% (p < 0.0001) achieved at least a 40% reduction from baseline in mean diurnal IOP. Pooled safety results were consistent with individual MERCURY studies.
CONCLUSION


Once-daily netarsudil/latanoprost FDC produced statistically significant and clinically relevant reductions in mean IOP that were statistically superior to IOP reductions achieved by netarsudil and latanoprost monotherapy. Results of the pooled efficacy and safety analyses were consistent with the individual studies.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers, NCT02558400 and NCT02674854.",2020,FDC met criteria for superiority compared with each active component (p < 0.0001 for all nine time points).,"['Ocular Hypertension and Open-Angle Glaucoma', 'patients with OAG or OHT']","['latanoprost', 'Netarsudil and Latanoprost', 'netarsudil/latanoprost FDC or latanoprost', 'fixed-dose combination (FDC) of netarsudil and the prostaglandin latanoprost', 'netarsudil/latanoprost FDC or netarsudil or latanoprost']","['Mean diurnal IOP', 'intraocular pressure (IOP', 'Baseline mean diurnal IOP', 'IOP', 'IOP reductions']","[{'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.164725,FDC met criteria for superiority compared with each active component (p < 0.0001 for all nine time points).,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Asrani', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA. sanjay.asrani@duke.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bacharach', 'Affiliation': 'North Bay Eye Associates, Petaluma, CA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Holland', 'Affiliation': 'Cincinnati Eye Institute, Cincinnati, OH, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'McKee', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Casey C', 'Initials': 'CC', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01277-2']
350,32189096,A Brief Clinic-Based Intervention to Reduce Alcohol Misuse and Sexual Risk Behavior in Young Women: Results from an Exploratory Clinical Trial.,"This exploratory trial determined the feasibility, acceptability, and preliminary efficacy of a brief intervention (BI), supplemented with text messaging and a curated Web site, on alcohol use and sexual risk behavior among young women. Young women seeking care at a reproductive health clinic were screened for alcohol misuse and sexual risk behavior. Those who screened positive and who agreed to participate (N = 48; M = 22.67 years) were randomized to either (a) a brief in-person session during which personalized feedback regarding alcohol use and sexual risk taking was provided and discussed, or (b) a control condition. Feasibility was assessed by recruitment and retention rates. Acceptability was assessed with participant ratings of their intervention. Efficacy was measured using self-reported alcohol use and sexual behavior at baseline and during a 3-month follow-up. We supplemented the quantitative data with qualitative data from semi-structured interviews. Feasibility data indicated that 64% of eligible women agreed to participate, 74% of eligible women were enrolled, and 86% of enrolled women were retained through follow-up. Acceptability data showed that women who received the BI reported strong satisfaction with their intervention (M = 4.65 vs. 3.98 on a five-point scale) and also reported that text messaging was helpful (M = 4.73 on a seven-point scale) and acceptable (M = 5.27 on a seven-point scale). Qualitative data provided additional support for BI feasibility and acceptability. Efficacy data showed that women in both conditions reduced alcohol use and sexual risk behavior over time; women who received the BI reduced their maximum daily alcohol intake more than controls (BI from 7.68 to 4.82 standard drinks vs. control from 6.48 to 5.65; Wald χ 2  = 4.93, p < .05). Women in the BI reported fewer occasions of condomless sex (median = 2.50) than controls (median = 5.00) at the follow-up, but this difference was not statistically significant (OR = 0.61, 95% CI [0.32, 1.15]). A brief intervention, supplemented with text messaging and a Web site, that targeted alcohol use and sexual behavior was feasible and acceptable to young women and led to lower levels of alcohol misuse and sexual risk behavior.",2020,"Efficacy data showed that women in both conditions reduced alcohol use and sexual risk behavior over time; women who received the BI reduced their maximum daily alcohol intake more than controls (BI from 7.68 to 4.82 standard drinks vs. control from 6.48 to 5.65; Wald χ 2  = 4.93, p < .05).","['Young women seeking care at a reproductive health clinic were screened for alcohol misuse and sexual risk behavior', 'Those who screened positive and who agreed to participate (N\u2009=\u200948; M\u2009=\u200922.67\xa0years', 'Young Women', 'young women', '64% of eligible women agreed to participate, 74% of eligible women were enrolled, and 86% of enrolled women']","['brief in-person session during which personalized feedback regarding alcohol use and sexual risk taking was provided and discussed, or (b) a control condition', 'brief intervention (BI), supplemented with text messaging and a curated Web site']","['Acceptability', 'alcohol use and sexual risk behavior', 'maximum daily alcohol intake', 'self-reported alcohol use and sexual behavior', 'Alcohol Misuse and Sexual Risk Behavior', 'Efficacy', 'condomless sex']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",,0.0400899,"Efficacy data showed that women in both conditions reduced alcohol use and sexual risk behavior over time; women who received the BI reduced their maximum daily alcohol intake more than controls (BI from 7.68 to 4.82 standard drinks vs. control from 6.48 to 5.65; Wald χ 2  = 4.93, p < .05).","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Carey', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA. Michael_Carey@brown.edu.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Rich', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Alyssa L', 'Initials': 'AL', 'LastName': 'Norris', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Krieger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Gavarkovs', 'Affiliation': 'Department of Behavioral and Social Science, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Kaplan', 'Affiliation': 'Department of Clinical Research, Planned Parenthood of Southern New England, New Haven, CT, USA.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Guthrie', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Coro West, Suite 309, 164 Summit Avenue, Providence, RI, 02906, USA.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Department of Behavioral and Social Science, School of Public Health, Brown University, Providence, RI, USA.'}]",Archives of sexual behavior,['10.1007/s10508-020-01635-9']
351,32078692,The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil.,"BACKGROUND


Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm.
OBJECTIVE


To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT).
METHODS


HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up.
RESULTS


A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
CONCLUSION


Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms.
VIDEO ABSTRACT


",2020,"Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
","['600 patients were randomized (HES, n\xa0=\xa0297 and BPC, n\xa0=\xa0303), including 28% with ruptured aneurysms', 'enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling']","['second-generation HES and bare platinum coil (BPC', 'Hydrogel Endovascular Aneurysm Treatment Trial (HEAT', 'Second-Generation Hydrogel Coil']","['Recurrence', 'minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up', 'adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms', 'packing density and both major and minor recurrence rates', 'initial occlusion rate', 'aneurysm recurrence using the Raymond-Roy scale']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162869', 'cui_str': 'Aneurysm, Ruptured'}, {'cui': 'C0007766', 'cui_str': 'Intracranial Aneurysm'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0222045'}]",600.0,0.104487,"Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
","[{'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Bendok', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Abi-Aad', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Ward', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Kniss', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Rudy J', 'Initials': 'RJ', 'LastName': 'Rahme', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Salah G', 'Initials': 'SG', 'LastName': 'Aoun', 'Affiliation': 'Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Tarek Y', 'Initials': 'TY', 'LastName': 'El Ahmadieh', 'Affiliation': 'Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Najib E', 'Initials': 'NE', 'LastName': 'El Tecle', 'Affiliation': 'Department of Neurological Surgery, Saint Louis University Hospital, St. Louis, Missouri.'}, {'ForeName': 'Samer G', 'Initials': 'SG', 'LastName': 'Zammar', 'Affiliation': 'Department of Neurological Surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Rami James N', 'Initials': 'RJN', 'LastName': 'Aoun', 'Affiliation': 'Department of General Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Devi P', 'Initials': 'DP', 'LastName': 'Patra', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Ansari', 'Affiliation': 'Department of Radiology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'Laboratoire de Neuroradiologie Interventionnelle, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Woo', 'Affiliation': 'Department of Neurological Surgery, North Shore University Hospital, Manhasset, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Radiology, Stony Brook University Hospital, Stony Brook, New York.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Dabus', 'Affiliation': 'Interventional Neuroradiology and Neuroendovascular Surgery, Miami Cardiac and Vascular Institute, Miami, Florida.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Milot', 'Affiliation': 'Département de Chirurgie, CHU de Quebec, Quebec City, Canada.'}, {'ForeName': 'Josser E', 'Initials': 'JE', 'LastName': 'Delgado Almandoz', 'Affiliation': 'Department of Neurointerventional Radiology, Abbott Northwestern Hospital, Minneapolis, Minnesota.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Scott', 'Affiliation': 'Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'DeNardo', 'Affiliation': 'Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana.'}, {'ForeName': 'Shervin R', 'Initials': 'SR', 'LastName': 'Dashti', 'Affiliation': 'Department of Neurological Surgery Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurosurgery,['10.1093/neuros/nyaa006']
352,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5']
353,31960045,"Commentary: Efficacy and Safety of Minimally Invasive Surgery With Thrombolysis in Intracerebral Haemorrhage Evacuation (MISTIE III): A Randomized, Controlled, Open-Label, Blinded Endpoint Phase 3 Trial.",,2020,,['Intracerebral Haemorrhage Evacuation (MISTIE III'],['Minimally Invasive Surgery'],[],"[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]",[],,0.154348,,"[{'ForeName': 'Mithun G', 'Initials': 'MG', 'LastName': 'Sattur', 'Affiliation': 'Department of Neurosurgery, Division of Neuroendovascular Surgery, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Spiotta', 'Affiliation': 'Department of Neurosurgery, Division of Neuroendovascular Surgery, Medical University of South Carolina, Charleston, South Carolina.'}]",Neurosurgery,['10.1093/neuros/nyz551']
354,31582408,Metabolite Profiles of Incident Diabetes and Heterogeneity of Treatment Effect in the Diabetes Prevention Program.,"Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development. We profiled 331 metabolites in 2,015 baseline plasma samples from the Diabetes Prevention Program (DPP). Cox models were used to determine associations between metabolites and incident T2D, as well as whether associations differed by treatment group (i.e., lifestyle [ILS], metformin [MET], or placebo [PLA]), over an average of 3.2 years of follow-up. We found 69 metabolites associated with incident T2D regardless of treatment randomization. In particular, cytosine was novel and associated with the lowest risk. In an exploratory analysis, 35 baseline metabolite associations with incident T2D differed across the treatment groups. Stratification by baseline levels of several of these metabolites, including specific phospholipids and AMP, modified the effect that ILS or MET had on diabetes development. Our findings highlight novel markers of diabetes risk and preventative treatment effect in individuals who are clinically at high risk and motivate further studies to validate these interactions.",2019,Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development.,"['2,015 baseline plasma samples from the Diabetes Prevention Program (DPP', 'individuals with similar clinical risk']","['cytosine', 'metformin (MET), or placebo (PLA']",[],"[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0010843', 'cui_str': 'Cytosine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],331.0,0.0206204,Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development.,"[{'ForeName': 'Zsu-Zsu', 'Initials': 'ZZ', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Biostatistics Center and Milken Institute School of Public Health, George Washington University, Rockville, MD.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Morningstar', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Christine G', 'Initials': 'CG', 'LastName': 'Lee', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Jane F', 'Initials': 'JF', 'LastName': 'Ferguson', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Hamman', 'Affiliation': 'Department of Epidemiology, Colorado School of Public Health, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Perreault', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Florez', 'Affiliation': 'Diabetes Unit and Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Clary', 'Initials': 'C', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of MIT and Harvard, Cambridge, MA.'}, {'ForeName': 'Marinella', 'Initials': 'M', 'LastName': 'Temprosa', 'Affiliation': 'Department of Epidemiology and Biostatistics, Biostatistics Center and Milken Institute School of Public Health, George Washington University, Rockville, MD.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gerszten', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0236']
355,32140704,Vitamin D status and cardiometabolic risk markers in young Swedish children: a double-blind randomized clinical trial comparing different doses of vitamin D supplements.,"BACKGROUND


Observational studies have linked low vitamin D status to unfavorable cardiometabolic risk markers, but double-blinded vitamin D intervention studies in children are scarce.
OBJECTIVES


The aim was to evaluate the effect of different doses of a vitamin D supplement on cardiometabolic risk markers in young healthy Swedish children with fair and dark skin.
METHODS


Cardiometabolic risk markers were analyzed as secondary outcomes of a double-blind, randomized, milk-based vitamin D intervention trial conducted during late fall and winter in 2 areas of Sweden (latitude 63°N and 55°N, respectively) in both fair- and dark-skinned 5- to 7-y-old children. During the 3-mo intervention, 206 children were randomly assigned to a daily milk-based vitamin D3 supplement of either 10 or 25 µg or placebo (2 µg; only at 55°N). Anthropometric measures, blood pressure, serum 25-hydroxyvitamin D [25(OH)D], total cholesterol, HDL cholesterol, apoA-I, apoB, and C-reactive protein (CRP) were analyzed and non-HDL cholesterol calculated at baseline and after the intervention.
RESULTS


At baseline, serum 25(OH)D was negatively associated with systolic and diastolic blood pressure (β = -0.194; 95% CI: -0.153, -0.013; and β = -0.187; 95% CI: -0.150, -0.011, respectively). At follow-up, there was no statistically significant difference in any of the cardiometabolic markers between groups.
CONCLUSIONS


We could not confirm any effect of vitamin D supplementation on serum lipids, blood pressure, or CRP in healthy 5- to 7-y-old children. The study was registered at clinicaltrials.gov (NCT01741324).",2020,"We could not confirm any effect of vitamin D supplementation on serum lipids, blood pressure, or CRP in healthy 5- to 7-y-old children.","['trial conducted during late fall and winter in 2 areas of Sweden (latitude 63°N and 55°N, respectively) in both fair- and dark-skinned 5- to 7-y-old children', 'young healthy Swedish children with fair and dark skin', 'healthy 5- to 7-y-old children', '206 children', 'young Swedish children']","['vitamin D supplementation', 'milk-based vitamin D intervention', 'vitamin D supplement', 'daily milk-based vitamin D3 supplement of either 10 or 25\xa0µg or placebo', 'vitamin D supplements']","['systolic and diastolic blood pressure', 'serum lipids, blood pressure, or CRP', 'cardiometabolic markers', 'cardiometabolic risk markers', 'HDL cholesterol calculated', 'Anthropometric measures, blood pressure, serum 25-hydroxyvitamin D [25(OH)D], total cholesterol, HDL cholesterol, apoA-I, apoB, and C-reactive protein (CRP', 'Vitamin D status and cardiometabolic risk markers']","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0756567', 'cui_str': 'apoA-I(Zavalla)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",206.0,0.54295,"We could not confirm any effect of vitamin D supplementation on serum lipids, blood pressure, or CRP in healthy 5- to 7-y-old children.","[{'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Öhlund', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Hernell', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sven-Arne', 'Initials': 'SA', 'LastName': 'Silfverdal', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Liv', 'Affiliation': 'Section of Sustainable Health, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Karlsland Åkeson', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Lund University, Lund, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa031']
356,32286711,"Effects of continuous and intermittent aerobic physical training on hormonal and metabolic profile, and body composition in women with polycystic ovary syndrome: A randomized controlled trial.","OBJECTIVE


To evaluate the effects of continuous (CA) and intermittent (IA) aerobic training on hormonal and metabolic parameters and body composition of women with polycystic ovary syndrome (PCOS).
DESIGN


Prospective, interventional, randomized study.
METHODS


Randomized controlled training (RCT) with sample allocation and stratification into three groups: CAT (n = 28) and IAT (n = 29) training and no training [control (CG), n = 30]. Before and after 16 weeks of intervention (CAT or IAT) or observation (CG), hormonal and metabolic parameters, body composition and anthropometric indices were evaluated. Aerobic physical training on a treadmill consisted of 30- to 50-minute sessions with intensities ranging from 60% to 90% of the maximum heart rate.
RESULTS


In the CA group, there was reduction in waist circumference (WC) (P = .045), hip circumference (P = .032), cholesterol (P ≤ .001), low-density lipoprotein (P = .030) and testosterone (P ≤ .001). In the IAT group, there was a reduction in WC (P = .014), waist-to-hip ratio (P = .012), testosterone (P = .019) and the free androgen index (FAI) (P = .037). The CG showed increases in WC (P = .049), total body mass (P = .015), body fat percentage (P = .034), total mass of the arms (P ≤ .001), trunk fat percentage (P = .033), leg fat percentage (P = .021) and total gynoid mass (P = .011).
CONCLUSION


CAT and IAT training reduced anthropometric indices and hyperandrogenism in PCOS, whereas only IAT training reduced the FAI. Furthermore, only CAT training improved the lipid profile.",2020,"In the CA group, there was reduction in waist circumference (WC) (p = 0.045), hip circumference (p = 0.032), cholesterol (p ≤ 0.001), low-density lipoprotein (p = 0.030), and testosterone (p ≤ 0.001).","['women with polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS']","['CAT and IAT training', 'continuous and intermittent aerobic physical training', 'Aerobic physical training', 'IAT (n = 29) training and no training [control (CG', 'continuous (CA) and intermittent (IA) aerobic training']","['cholesterol', 'total gynoid mass', 'leg fat percentage', 'waist circumference (WC', 'hormonal and metabolic profile, and body composition', 'reduction in WC', 'waist-to-hip ratio', 'free androgen index (FAI', 'body fat percentage', 'total mass', 'hip circumference', 'WC', 'trunk fat percentage', 'lipid profile', 'low-density lipoprotein', 'total body mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",,0.0782393,"In the CA group, there was reduction in waist circumference (WC) (p = 0.045), hip circumference (p = 0.032), cholesterol (p ≤ 0.001), low-density lipoprotein (p = 0.030), and testosterone (p ≤ 0.001).","[{'ForeName': 'Victor B', 'Initials': 'VB', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Gislaine Satyko', 'Initials': 'GS', 'LastName': 'Kogure', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Iris Palma', 'Initials': 'IP', 'LastName': 'Lopes', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Rafael C', 'Initials': 'RC', 'LastName': 'Silva', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Daiana Cristina Chielli', 'Initials': 'DCC', 'LastName': 'Pedroso', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Anderson S', 'Initials': 'AS', 'LastName': 'de Melo', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Hugo C D', 'Initials': 'HCD', 'LastName': 'de Souza', 'Affiliation': 'Department of Biomechanics, Medicine and Rehabilitation of the Locomotor Apparatus, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Rui Alberto', 'Initials': 'RA', 'LastName': 'Ferriani', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Cristiana Libardi', 'Initials': 'CL', 'LastName': 'Miranda Furtado', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Rosana Maria', 'Initials': 'RM', 'LastName': 'Dos Reis', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}]",Clinical endocrinology,['10.1111/cen.14194']
357,32020168,"Reformulation initiative for partial replacement of saturated with unsaturated fats in dairy foods attenuates the increase in LDL cholesterol and improves flow-mediated dilatation compared with conventional dairy: the randomized, controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) study.","BACKGROUND


Modifying dairy fat composition by increasing the MUFA content is a potential strategy to reduce dietary SFA intake for cardiovascular disease (CVD) prevention in the population.
OBJECTIVES


To determine the effects of consuming SFA-reduced, MUFA-enriched (modified) dairy products, compared with conventional dairy products (control), on the fasting cholesterol profile (primary outcome), endothelial function assessed by flow-mediated dilatation (FMD; key secondary outcome), and other cardiometabolic risk markers.
METHODS


A double-blind, randomized, controlled crossover 12-wk intervention was conducted. Participants with a 1.5-fold higher (moderate) CVD risk than the population mean replaced habitual dairy products with study products (milk, cheese, and butter) to achieve a high-fat, high-dairy isoenergetic daily dietary exchange [38% of total energy intake (%TE) from fat: control (dietary target: 19%TE SFA; 11%TE MUFA) and modified (16%TE SFA; 14%TE MUFA) diet].
RESULTS


Fifty-four participants (57.4% men; mean ± SEM age: 52 ± 3 y; BMI: 25.8 ± 0.5 kg/m2) completed the study. The modified diet attenuated the rise in fasting LDL cholesterol observed with the control diet (0.03 ± 0.06 mmol/L and 0.19 ± 0.05 mmol/L, respectively; P = 0.03). Relative to baseline, the %FMD response increased after the modified diet (0.35% ± 0.15%), whereas a decrease was observed after the control diet (-0.51% ± 0.15%; P< 0.0001). In addition, fasting plasma nitrite concentrations increased after the modified diet, yet decreased after the control diet (0.02 ± 0.01 μmol/L and -0.03 ± 0.02 μmol/L, respectively; P = 0.01).
CONCLUSIONS


In adults at moderate CVD risk, consumption of a high-fat diet containing SFA-reduced, MUFA-enriched dairy products for 12 wk showed beneficial effects on fasting LDL cholesterol and endothelial function compared with conventional dairy products. Our findings indicate that fatty acid modification of dairy products may have potential as a public health strategy aimed at CVD risk reduction. This trial was registered at clinicaltrials.gov as NCT02089035.",2020,"The modified diet attenuated the rise in fasting LDL cholesterol observed with the control diet (0.03 ± 0.06 mmol/L and 0.19 ± 0.05 mmol/L, respectively; P = 0.03).","['SEM age: 52\xa0±\xa03 y; BMI: 25.8\xa0±\xa00.5 kg/m2) completed the study', 'Participants with a 1.5-fold higher (moderate) CVD risk than the population mean replaced habitual dairy products with study products (milk, cheese, and butter', 'Fifty-four participants (57.4% men']","['consuming SFA-reduced, MUFA-enriched (modified) dairy products, compared with conventional dairy products (control']","['LDL cholesterol and improves flow-mediated dilatation', 'fasting LDL cholesterol', 'fasting LDL cholesterol and endothelial function', 'mean\xa0±', 'FMD response', 'fasting cholesterol profile (primary outcome), endothelial function assessed by flow-mediated dilatation (FMD; key secondary outcome), and other cardiometabolic risk markers', 'fasting plasma nitrite concentrations']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}]",54.0,0.185327,"The modified diet attenuated the rise in fasting LDL cholesterol observed with the control diet (0.03 ± 0.06 mmol/L and 0.19 ± 0.05 mmol/L, respectively; P = 0.03).","[{'ForeName': 'Dafni', 'Initials': 'D', 'LastName': 'Vasilopoulou', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Oonagh', 'Initials': 'O', 'LastName': 'Markey', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Kirsty E', 'Initials': 'KE', 'LastName': 'Kliem', 'Affiliation': 'Animal, Dairy and Food Chain Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Colette C', 'Initials': 'CC', 'LastName': 'Fagan', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Alistair S', 'Initials': 'AS', 'LastName': 'Grandison', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Humphries', 'Affiliation': 'Animal, Dairy and Food Chain Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Todd', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Kim G', 'Initials': 'KG', 'LastName': 'Jackson', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Givens', 'Affiliation': 'Institute for Food, Nutrition and Health, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Lovegrove', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz344']
358,32160298,Differential effects of phosphate binders on vitamin D metabolism in chronic kidney disease.,"BACKGROUND


Phosphate binders are commonly used in the treatment of patients with hyperphosphatemia. While phosphate binders are used to lower phosphate, the effects of specific phosphate binder types on vitamin D metabolism are unknown.
METHODS


We performed a secondary analysis of the Phosphate Normalization Trial in which patients with moderate to advanced chronic kidney disease were randomized to receive either placebo, sevelamer carbonate, lanthanum carbonate or calcium acetate for 9 months. We evaluated changes in serum concentrations of vitamin D metabolites including 24,25-dihydroxyvitamin D3 [24,25(OH)2D3], 1,25-dihydroxyvitamin D3 [1,25(OH)2D3], the ratio of 24,25(OH)2D3 to 25-hydroxyvitamin D [the vitamin D metabolite ratio (VMR)] and the ratio of serum 1,25(OH)2D to 25-hydroxyvitamin D.
RESULTS


Compared with placebo, randomization to the calcium acetate arm was associated with a 0.6 ng/mL (95% CI 0.2, 1) and 13.5 pg/ng (95% CI 5.5, 21.5) increase in 24,25(OH)2D and VMR, respectively, and a 5.2 pg/mL (95% CI 1.1, 9.4) reduction in 1,25(OH)2D. Randomization to sevelamer carbonate was associated with a 0.5 ng/mL (95% CI -0.9, -0.1) and 11.8 pg/ng (95% CI -20, -3.5) reduction in 24,25(OH)2D3 and VMR, respectively. There was no association of the sevelamer arm with the change in 1,25(OH)2D3, and randomization to lanthanum carbonate was not associated with a change in any of the vitamin D metabolites.
CONCLUSION


Administration of different phosphate binders to patients with moderate to severe CKD results in unique changes in vitamin D metabolism.",2020,"There was no association of the sevelamer arm with the change in 1,25(OH)2D3, and randomization to lanthanum carbonate was not associated with a change in any of the vitamin D metabolites.
","['chronic kidney disease', 'patients with moderate to advanced chronic kidney disease', 'patients with hyperphosphatemia', 'patients with moderate to severe CKD']","['placebo, sevelamer carbonate, lanthanum carbonate or calcium acetate', 'lanthanum carbonate', 'phosphate binders']","['vitamin D metabolism', '24,25(OH)2D and VMR', 'serum concentrations of vitamin D metabolites including 24,25-dihydroxyvitamin D3 [24,25(OH)2D3], 1,25-dihydroxyvitamin D3 [1,25(OH)2D3], the ratio of 24,25(OH)2D3 to 25-hydroxyvitamin D [the vitamin D metabolite ratio (VMR)] and the ratio of serum 1,25(OH)2D to 25-hydroxyvitamin D']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemias'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007026', 'cui_str': 'Carbonates'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0717537', 'cui_str': 'calcium acetate'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0886858', 'cui_str': '(24R)-24,25-Dihydroxyvitamin D3'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",,0.0844352,"There was no association of the sevelamer arm with the change in 1,25(OH)2D3, and randomization to lanthanum carbonate was not associated with a change in any of the vitamin D metabolites.
","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ginsberg', 'Affiliation': 'Division of Nephrology-Hypertension, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Nephrology, Reata Pharmaceuticals, Inc., Plano, TX, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Anschutz Medical Center, Aurora, CO, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hoofnagle', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Kestenbaum', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa010']
359,31691831,"Acoustic slow wave sleep enhancement via a novel, automated device improves executive function in middle-aged men.","STUDY OBJECTIVES


As slow-wave activity (SWA) is critical for cognition, SWA-enhancing technologies provide an exciting opportunity to improve cognitive function. We focus on improving cognitive function beyond sleep-dependent memory consolidation, using an automated device, and in middle-aged adults, who have depleted SWA yet a critical need for maximal cognitive capacity in work environments.
METHODS


Twenty-four healthy adult males aged 35-48 years participated in a randomized, double-blind, cross-over study. Participants wore an automated acoustic stimulation device that monitored real-time sleep EEG. Following an adaptation night, participants were exposed to either acoustic tones delivered on the up phase of the slow-wave (STIM) or inaudible ""tones"" during equivalent periods of stimulation (SHAM). An executive function test battery was administered after the experimental night.
RESULTS


STIM resulted in an increase in delta (0.5-4 Hz) activity across the full-night spectra, with enhancement being maximal at 1 Hz. SWA was higher for STIM relative to SHAM. Although no group differences were observed in any cognitive outcomes, due to large individual differences in SWA enhancement, higher SWA responders showed significantly improved verbal fluency and working memory compared with nonresponders. Significant positive associations were found between SWA enhancement and improvement in these executive function outcomes.
CONCLUSIONS


Our study suggests that (1) an automated acoustic device enhances SWA; (2) SWA enhancement improves executive function; (3) SWA enhancement in middle-aged men may be an important therapeutic target for enhancing cognitive function; and (4) there is a need to examine interindividual responses to acoustic stimulation and its effect on subsequent cognitive function.
CLINICAL TRIAL REGISTRATION


This study has been registered with the Australian New Zealand Clinical Trials Registry. ""The efficacy of acoustic tones in slow-wave sleep enhancement and cognitive function in healthy adult males"". https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371548&isReview=true.
REGISTRATION


ACTRN12617000399392.",2020,SWA was higher for STIM relative to SHAM.,"['middle-aged men', 'middle-aged adults', 'healthy adult males', 'Twenty-four healthy adult males aged 35-48 years']","['acoustic tones delivered on the up phase of the slow-wave (STIM) or inaudible ""tones"" during equivalent periods of stimulation (SHAM', 'https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371548&isReview=true', 'acoustic tones', 'automated acoustic stimulation device that monitored real-time sleep EEG', 'automated acoustic device enhances SWA', 'Acoustic slow wave sleep enhancement via a novel, automated device']","['verbal fluency and working memory', 'delta (0.5-4 Hz) activity', 'cognitive outcomes', 'executive function outcomes', 'executive function']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram (procedure)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",24.0,0.203545,SWA was higher for STIM relative to SHAM.,"[{'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Diep', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ftouni', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Manousakis', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Nicholas', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}]",Sleep,['10.1093/sleep/zsz197']
360,32279690,Resistant starch supplementation increases crypt cell proliferative state in the rectal mucosa of older healthy participants.,"There is strong evidence that foods containing dietary fibre protect against colorectal cancer, resulting at least in part from its anti-proliferative properties. This study aimed to investigate the effects of supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD), on crypt cell proliferative state (CCPS) in the macroscopically normal rectal mucosa of healthy individuals. We also investigated relationships between expression of regulators of apoptosis and of the cell cycle on markers of CCPS. Seventy-five healthy participants were supplemented with RS and/or PD or placebo for 50 d in a 2 × 2 factorial design in a randomised, double-blind, placebo-controlled trial (the Dietary Intervention, Stem cells and Colorectal Cancer (DISC) Study). CCPS was assessed, and the expression of regulators of the cell cycle and of apoptosis was measured by quantitative PCR in rectal mucosal biopsies. SCFA concentrations were quantified in faecal samples collected pre- and post-intervention. Supplementation with RS increased the total number of mitotic cells within the crypt by 60 % (P = 0·001) compared with placebo. This effect was limited to older participants (aged ≥50 years). No other differences were observed for the treatments with PD or RS as compared with their respective controls. PD did not influence any of the measured variables. RS, however, increased cell proliferation in the crypts of the macroscopically-normal rectum of older adults. Our findings suggest that the effects of RS on CCPS are not only dose, type of RS and health status-specific but are also influenced by age.",2020,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"['75 healthy participants', 'older participants (aged ≥50', 'older healthy participants', 'macroscopically-normal rectal mucosa of healthy individuals']","['RS and/or PD or placebo', 'supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD', 'Resistant starch supplementation', 'placebo']","['expression of regulators of the cell cycle and of apoptosis', 'SCFA concentrations', 'total number of mitotic cells', 'crypt cell proliferative state (CCPS', 'cell proliferation', 'crypt cell proliferative state']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0227395', 'cui_str': 'Rectal mucous membrane structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0230518', 'cui_str': 'Mitotic cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}]",75.0,0.290488,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Malcomson', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCallum', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'DuPont Nutrition & Biosciences, 02460Kantvik, Finland.'}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Stowell', 'Affiliation': 'DuPont Nutrition & Biosciences, ReigateRH2 9PQ, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Bradburn', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, AshingtonNE63 9JJ, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Belshaw', 'Affiliation': 'University of East Anglia, Norwich Research Park, NorwichNR4 7TJ, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Johnson', 'Affiliation': 'Quadram Institute, Norwich Research Park, NorwichNR4 7UQ, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001312']
361,32286620,Early Child Development Outcomes of a Randomized Trial Providing 1 Egg Per Day to Children Age 6 to 15 Months in Malawi.,"BACKGROUND


Eggs are a rich source of nutrients important for brain development, including choline, riboflavin, vitamins B-6 and B-12, folate, zinc, protein, and DHA.
OBJECTIVE


Our objective was to evaluate the effect of the consumption of 1 egg per day over a 6-mo period on child development.
METHODS


In the Mazira Project randomized controlled trial, 660 children aged 6-9 mo were randomly allocated into an intervention or control group. Eggs were provided to intervention households during twice-weekly home visits for 6 mo. Control households were visited at the same frequency. At enrollment, blinded assessors administered the Malawi Developmental Assessment Tool (MDAT), and 2 eye-tracking tasks using a Tobii-Pro X2-60 eye tracker: a visual paired comparison memory task and an Infant Orienting with Attention task. At endline, 6-mo later, blinded assessors administered the MDAT and eye-tracking tasks plus an additional elicited imitation memory task.
RESULTS


At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91). Among 10 prespecified effect modifiers for the 8 primary developmental outcomes, we found 7 significant interactions demonstrating a consistent pattern that children who were less vulnerable, for example, those with higher household wealth and maternal education, showed positive effects of the intervention. Given multiple hypothesis testing, some findings may have been due to chance.
CONCLUSION


The provision of 1 egg per day had no overall effect on child development in this population of children, however, some benefits may be seen among children in less vulnerable circumstances. This trial was registered at clinicaltrials.gov as NCT03385252.",2020,"At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91).",['660 children aged 6-9 mo'],"['Malawi Developmental Assessment Tool (MDAT), and 2 eye-tracking tasks using a Tobii-Pro X2-60 eye tracker: a visual paired comparison memory task and an Infant Orienting with Attention task']","['developmental score', 'fine motor development']","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}]","[{'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0086766', 'cui_str': 'Paired Comparisons'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",660.0,0.253052,"At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91).","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Bess L', 'Initials': 'BL', 'LastName': 'Caswell', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Matthews', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Oakes', 'Affiliation': 'Department of Psychology and Center for Mind and Brain, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Michaela C', 'Initials': 'MC', 'LastName': 'DeBolt', 'Affiliation': 'Department of Psychology and Center for Mind and Brain, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Megan G', 'Initials': 'MG', 'LastName': 'Bragg', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Institute for Public Health, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'RTI International, Washington DC, School of Public Health, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa088']
362,32286685,A randomized controlled trial of a tablet-based intervention to address predonation fears among high school donors.,"BACKGROUND


Prior studies have shown donation-related fear to be associated with decreased donor confidence and an increased risk for vasovagal reactions. This study examined the effects of a predonation intervention that provided fearful donors with suggestions for coping.
STUDY DESIGN AND METHODS


Using a tablet-based application, high school donors (49.4% female) answered a question regarding their fear of having blood drawn. Those who reported fear were randomly assigned to either a control (n = 930) or an intervention (n = 911) group. Donors in the control group rated their confidence in dealing with their fear and then donated as usual. Donors in the intervention group received a brief audiovisual presentation on coping strategies, rated their confidence, and then donated as usual.
RESULTS


A higher proportion of fearful versus nonfearful donors experienced a vasovagal reaction, even after controlling for other demographic and health predictors (OR, 2.3; 95% CI, 1.655-3.185, p < 0.001). Fearful donors who received the intervention reported greater confidence than controls, but the proportion of vasovagal reactions did not differ significantly between the intervention (6.1%) and control (6.8%) groups.
CONCLUSION


Although the current tablet-based intervention may have some psychological benefit in that it was associated with greater donor confidence, the observed effect was small and did not translate into a lower risk for vasovagal reactions. However, greater confidence among young donors may lead to an increased willingness to donate again-a potential outcome that we will revisit among these donors as part of a planned 2-year follow-up.",2020,"Fearful donors who received the intervention reported greater confidence than controls, but the proportion of vasovagal reactions did not differ significantly between the intervention (6.1%) and control (6.8%) groups.
","['Using a tablet-based application, high school donors (49.4% female) answered a question regarding their fear of having blood drawn', 'high school donors']","['predonation intervention', 'tablet-based intervention', 'brief audiovisual presentation']","['vasovagal reaction', 'proportion of vasovagal reactions']","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}]",,0.0370992,"Fearful donors who received the intervention reported greater confidence than controls, but the proportion of vasovagal reactions did not differ significantly between the intervention (6.1%) and control (6.8%) groups.
","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Kowalsky', 'Affiliation': 'Department of Psychology, Ohio State University Newark, Newark, Ohio, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Conatser', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Duffy', 'Affiliation': 'New York Blood Center Enterprises, New York, New York, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Barnofsky', 'Affiliation': 'New York Blood Center Enterprises, New York, New York, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'New York Blood Center Enterprises, New York, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'New York Blood Center Enterprises, New York, New York, USA.'}]",Transfusion,['10.1111/trf.15790']
363,32069352,Leptin partially mediates the association between early-life nutritional supplementation and long-term glycemic status among women in a Guatemalan longitudinal cohort.,"BACKGROUND


Early-life exposure to improved nutrition is associated with decreased risk of diabetes but increased risk of obesity. Leptin positively correlates with adiposity and has glucose-lowering effects, thus it may mediate the association of early-life nutrition and long-term glycemic status.
OBJECTIVES


We aimed to investigate the role of leptin in the differential association between early-life nutrition and the risks of obesity and diabetes.
METHODS


We analyzed data from a Guatemalan cohort who were randomly assigned at the village level to receive nutritional supplements as children. We conducted mediation analysis to examine the role of leptin in the associations of early-life nutrition and adult cardiometabolic outcomes.
RESULTS


Among 1112 study participants aged (mean ± SD) 44.1 ± 4.2 y, 60.6% were women. Cardiometabolic conditions were common: 40.2% of women and 19.4% of men were obese, and 53.1% of women and 41.0% of men were hyperglycemic or diabetic. Median (IQR) leptin concentration was 15.2 ng/mL (10.2-17.3 ng/mL) in women and 2.7 ng/mL (1.3-5.3 ng/mL) in men. Leptin was positively correlated with BMI (Spearman's ρ was 0.6 in women, 0.7 in men). Women exposed to improved nutrition in early life had 2.8-ng/mL (95% CI: 0.3, 5.3 ng/mL) higher leptin and tended to have lower fasting glucose (-0.8 mmol/L; -1.8, 0.2 mmol/L, nonsignificant) than unexposed women. There were no significant differences in leptin (-0.7 ng/mL; -2.1, 0.8 ng/mL) or fasting glucose (0.2 mmol/L; -0.5, 0.9 mmol/L) in men exposed to improved nutrition in early life compared with unexposed men. Leptin mediated 34.9% of the pathway between early-life nutrition and fasting glucose in women. The mediation in women was driven by improved pancreatic β-cell function. We did not observe the mediation effect in men.
CONCLUSIONS


Leptin mediated the glucose-lowering effect of early-life nutrition in women but not in men.",2020,"There were no significant differences in leptin (-0.7 ng/mL; -2.1, 0.8 ng/mL) or fasting glucose (0.2 mmol/L; -0.5, 0.9 mmol/L) in men exposed to improved nutrition in early life compared with unexposed men.","['men', 'women in a Guatemalan longitudinal cohort', 'women', 'women but not in men', '1112 study participants aged (mean\xa0±\xa0SD']",['nutritional supplements'],"['fasting glucose', 'pancreatic β-cell function', 'Leptin', 'leptin', 'Median (IQR) leptin concentration', 'Cardiometabolic conditions', 'hyperglycemic or diabetic']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",1112.0,0.135746,"There were no significant differences in leptin (-0.7 ng/mL; -2.1, 0.8 ng/mL) or fasting glucose (0.2 mmol/L; -0.5, 0.9 mmol/L) in men exposed to improved nutrition in early life compared with unexposed men.","[{'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ngoc-Anh', 'Initials': 'NA', 'LastName': 'Le', 'Affiliation': 'Biomarker Core Laboratory, Foundation for Atlanta Veterans Education and Research, Atlanta Veterans Affairs Medical Center, Atlanta, GA, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa001']
364,31950134,Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial.,"BACKGROUND


Obese children are vulnerable to vitamin D deficiency and impaired cardiovascular health; vitamin D replenishment might improve their cardiovascular health.
OBJECTIVES


The aims were to determine, in vitamin D-deficient overweight and obese children, whether supplementation with vitamin D3 1000 or 2000 IU/d is more effective than 600 IU/d in improving arterial endothelial function, arterial stiffness, central and systemic blood pressure (BP), insulin sensitivity (1/fasting insulin concentration), fasting glucose concentration, and lipid profile and to explore whether downregulation of adipocytokines and markers of systemic inflammation underlies vitamin D effects.
METHODS


We conducted a randomized, double-masked, controlled clinical trial in 225 10- to 18-y-old eligible children. Change in endothelial function at 6 mo was the primary outcome.
RESULTS


Dose-response increases in serum 25-hydroxyvitamin D concentrations were significant and tolerated without developing hypercalcemia. Changes at 3 and 6 mo in endothelial function, arterial stiffness, systemic-systolic BP, lipids, and inflammatory markers did not differ between children receiving 1000 or 2000 IU vitamin D and children receiving 600 IU. Some secondary outcomes differed between groups. Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57 (-5.97, -1.17), and -3.28 (-5.55, -1.00) mm Hg, respectively]; insulin sensitivity increased at 3 and 6 mo and fasting glucose concentration declined at 6 mo (-2.67; 95% CI: -4.88, -0.46 mg/dL) in the 2000-IU group.
CONCLUSIONS


Correction of vitamin D deficiency in overweight and obese children by vitamin D3 supplementation with 1000 or 2000 IU/d versus 600 IU/d did not affect measures of arterial endothelial function or stiffness, systemic inflammation, or lipid profile, but resulted in reductions in BP and fasting glucose concentration and in improvements in insulin sensitivity. Optimization of children's vitamin D status may improve their cardiovascular health. This trial was registered at clinicaltrials.gov as NCT01797302.",2020,"Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57","['vitamin D-deficient overweight and obese children', 'Obese children', 'deficient overweight and obese children', '225 10- to 18-y-old eligible children', 'overweight and obese children']","['vitamin D', 'vitamin D3 supplementation', 'supplementation with vitamin D3']","['arterial endothelial function or stiffness, systemic inflammation, or lipid profile', 'fasting glucose concentration', 'insulin sensitivity', 'central-systolic, central-diastolic, and systemic-diastolic BP', '25-hydroxyvitamin D concentrations', 'arterial endothelial function, arterial stiffness, central and systemic blood pressure (BP), insulin sensitivity (1/fasting insulin concentration), fasting glucose concentration, and lipid profile', 'serum', 'endothelial function', 'BP and fasting glucose concentration', 'vascular and metabolic health', 'endothelial function, arterial stiffness, systemic-systolic BP, lipids, and inflammatory markers']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.646145,"Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57","[{'ForeName': 'Kumaravel', 'Initials': 'K', 'LastName': 'Rajakumar', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Charity G', 'Initials': 'CG', 'LastName': 'Moore', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Arshad T', 'Initials': 'AT', 'LastName': 'Khalid', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Abbe N', 'Initials': 'AN', 'LastName': 'Vallejo', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Virji', 'Affiliation': 'Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Holick', 'Affiliation': 'Department of Medicine, Boston University Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Reis', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz340']
365,32280979,"On ""Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study."" Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Phys Ther. 2019; 99:203-216.",,2020,,['People With Parkinson Disease'],['mHealth-Supported Exercise Compared With Exercise Alone'],"['Ellis TD, Cavanaugh, JT, DeAngelis, T, Hendron, K, Thomas, CA, Saint-Hilaire, M, Pencina, K, Latham, NK']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0242823', 'cui_str': 'Saints'}]",,0.0311955,,"[{'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Scorza', 'Affiliation': 'Disciplina de Neurociência, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM), São Paulo, Brazil.'}, {'ForeName': 'Laís', 'Initials': 'L', 'LastName': 'Rodrigues', 'Affiliation': 'Disciplina de Neurociência, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'Disciplina de Neurociência, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo/Escola Paulista de Medicina (UNIFESP/EPM).'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Finsterer', 'Affiliation': 'Krankenanstalt Rudolfstiftung, Vienna, Messerli Institute, Veterinary University of Vienna, Vienna, Austria.'}]",Physical therapy,['10.1093/ptj/pzaa061']
366,32043980,Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial.,"BACKGROUND


GRECCAR 2 was the first multicentre, randomised trial to compare local excision with total mesorectal excision in downstaged low rectal cancer. Encouraging oncological results were noted at 3 years' follow-up but needed to be corroborated with longer follow-up. In this study, we aimed to report the 5-year oncological outcomes, including local recurrence, metastatic disease, and survival.
METHODS


Patients age 18 years and older with T2T3 low rectal cancer, of maximum size 4 cm, who were clinically good responders after chemoradiotherapy (residual tumour ≤2 cm) were randomly assigned before surgery to either local excision or total mesorectal excision. Randomisation was centralised and not stratified and used permuted blocks of size eight. In the local excision group, a completion total mesorectal excision was performed if pathological tumour stage was ypT2-3. The primary objective of this study was to assess the 5-year oncological outcomes of local recurrence, metastatic disease, disease-free survival, overall survival, and cancer-specific mortality, which were the secondary endpoints of GRECCAR 2. We used Kaplan-Meier estimates and Cox modelling to estimate and compare recurrence and survival in modified intention-to-treat and as-treated populations. This trial was registered with ClinicalTrials.gov, number NCT00427375.
FINDINGS


Between March 1, 2007, and Sept 24, 2012, 148 patients who were good clinical responders were randomly assigned to treatment, three patients were excluded after randomisation (because they had metastatic disease, tumour >8 cm from anal verge, or withdrew consent), leaving 145 for analysis: 74 in the local excision group and 71 in the total mesorectal excision group. Median follow-up was 60 months (IQR 58-60) in the local excision group and 60 months (57-60) in the total mesorectal excision group. 23 patients died and five were lost to follow-up. In the local excision group, 26 had a completion total mesorectal excision for ypT2-3 tumour. In the modified intention-to-treat analysis, there was no difference between the local excision and total mesorectal excision groups in 5-year local recurrence (7% [95% CI 3-16] vs 7% [3-16]; adjusted hazard ratio [HR] 0·71 [95% CI 0·19-2·58]; p=0·60), metastatic disease (18% [CI 11-30] vs 19% [11-31]; 0·86 [0·36-2·06]; p=0·73), overall survival (84% [73-91] vs 82% [71-90]; 0·92 [0·38-2·22]; p=0·85), disease-free survival (70% [58-79] vs 72% [60-82]; 0·87 [0·44-1·72]; p=0·68), or cancer-specific mortality (7% [3-17] vs 10% [5-20]; 0·65 [0·17-2·49]; p=0·53).
INTERPRETATION


The 5-year results of this multicentre randomised trial corroborate the 3-year results, providing no evidence of difference in oncological outcomes between local excision and total mesorectal excision. Local excision can be proposed in selected patients having a small T2T3 low rectal cancer with a good clinical response after chemoradiotherapy.
FUNDING


National Cancer Institute of France.",2020,"Local excision can be proposed in selected patients having a small T2T3 low rectal cancer with a good clinical response after chemoradiotherapy.
","['Patients age 18 years and older with T2T3 low rectal cancer, of maximum size 4 cm, who were clinically good responders after chemoradiotherapy (residual tumour ≤2 cm', '148 patients who were good clinical responders were randomly assigned to treatment, three patients were excluded after randomisation (because they had metastatic disease, tumour >8 cm from anal verge, or withdrew consent), leaving 145 for analysis: 74 in the local excision group and 71 in the total mesorectal excision group', '0·65', 'rectal cancer', 'downstaged low rectal cancer', '23 patients died and five were lost to follow-up', 'selected patients having a small T2T3 low rectal cancer with a good clinical response after chemoradiotherapy']","['local excision with total mesorectal excision', 'completion total mesorectal excision', 'local excision and total mesorectal excision', 'chemoradiotherapy plus local excision', 'Local excision', 'local excision or total mesorectal excision']","['disease-free survival', 'local excision and total mesorectal excision groups in 5-year local recurrence', 'cancer-specific mortality', '5-year oncological outcomes of local recurrence, metastatic disease, disease-free survival, overall survival, and cancer-specific mortality', 'completion total mesorectal excision', 'metastatic disease', '5-year oncological outcomes', 'overall survival', 'local recurrence, metastatic disease, and survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumor'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0278259', 'cui_str': 'Local resection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]","[{'cui': 'C0278259', 'cui_str': 'Local resection'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0278259', 'cui_str': 'Local resection'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",3.0,0.510846,"Local excision can be proposed in selected patients having a small T2T3 low rectal cancer with a good clinical response after chemoradiotherapy.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullier', 'Affiliation': 'Department of Colorectal Surgery, Haut-Lévèque Hospital, CHU Bordeaux, France. Electronic address: eric.rullier@chu-bordeaux.fr.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Vendrely', 'Affiliation': 'Radiotherapy Department, Haut-Lévèque Hospital, CHU Bordeaux, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Asselineau', 'Affiliation': ""INSERM CIC1401-EC, Bordeaux, France; CHU Bordeaux, Service d'information médicale, Bordeaux, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': ""Département de Chirurgie Oncologique, ICM Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Service de Chirurgie Digestive, CHU Charles Nicolle, Rouen, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Valverde', 'Affiliation': 'Service de Chirurgie Digestive, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'de Chaisemartin', 'Affiliation': 'Département de Chirurgie Oncologique, Institut Paoli Calmette, Marseille, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rivoire', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Trilling', 'Affiliation': 'Service de Chirurgie Digestive, Hôpital A. Michallon, La Tronche, France.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Portier', 'Affiliation': 'Service de Chirurgie Digestive, Hôpital Purpan, Toulouse, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Service de Chirurgie Viscérale, CHU Pontchaillou, Rennes, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sieleznieff', 'Affiliation': 'Service de Chirurgie Digestive, CHU Timone, Marseille, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bertrand', 'Affiliation': 'Département de Chirurgie Digestive et de Cancérologie Digestive, Hôpital Universitaire Carémeau, Nimes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'Département de Chirurgie Oncologique, Institut de Cancérologie de Lorraine, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dubois', 'Affiliation': 'Service de Chirurgie Générale et Digestive, Hôtel Dieu, Clermont-Ferrand, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pocard', 'Affiliation': 'Département Médico-Chirurgical de Pathologie Digestive, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rullier', 'Affiliation': ""Service d'Anatomopathologie, Hôpital Pellegrin, Bordeaux, CHU Bordeaux, France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': ""Service d'Oncologie médicale, Haut-Lévèque Hospital, CHU Bordeaux, France.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Frulio', 'Affiliation': 'Service de Radiologie, Haut-Lévèque Hospital, CHU Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Frison', 'Affiliation': ""INSERM CIC1401-EC, Bordeaux, France; CHU Bordeaux, Service d'information médicale, Bordeaux, France.""}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Denost', 'Affiliation': 'Department of Colorectal Surgery, Haut-Lévèque Hospital, CHU Bordeaux, France.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30410-8']
367,31731885,Short Communication: Metformin Reduces CD4 T Cell Exhaustion in HIV-Infected Adults on Suppressive Antiretroviral Therapy.,"Increased negative immune checkpoint receptors (NCR) on T cells are linked to T cell exhaustion, dysfunctional effector responses, and HIV viral persistence. Metformin, an oral hypoglycemic agent used for diabetes, may have previously unrecognized beneficial immunologic effects. Using cryopreserved blood from a 24-week pilot study involving 12 virally suppressed HIV-infected individuals randomized 1:1 to metformin versus observation (OBS), we assessed change in the frequencies of T cell activation (CD38 + HLA-DR + ) and NCR [programmed cell death protein 1 (PD1), T cell immunoreceptor with Ig and ITIM domains (TIGIT), and T cell mucin-domain containing-3 (TIM3)]. No differences in 24-week change were seen between arms in CD4 or CD8 T cells, in the CD4/CD8 ratio, or in activated (CD38 + HLA-DR + ) CD4 or CD8 T cells. However, metformin over 24 weeks led to decreases compared with OBS in single PD1 +  (percent decrease: -9.6% vs. 7.5%,  p  = .015), in dual PD1 + TIGIT +  (-15.0% vs. 10.4%,  p  = .002), and in triple PD1 + TIGIT + TIM3 +  (-24.0% vs. 8.1%,  p  = .041) CD4 T cells. Metformin led to no changes in CD8 T cell NCR frequencies. Metformin decreases the frequency of PD1 + , PD1 + TIGIT + , and PD1 + TIGIT + TIM3 +  expressing CD4 T cells. This may have relevance to HIV cure strategies and to efforts to mitigate the risk of chronic complications of HIV.",2020,"No differences in 24-week change were seen between arms in CD4 or CD8 T-cells, in the CD4/CD8 ratio, or in activated (CD38+HLA-DR+) CD4 or CD8 T-cells.","['HIV-Infected Adults on Suppressive Antiretroviral Therapy', 'Using cryopreserved blood from a 24-week pilot study involving 12 virally-suppressed HIV-infected individuals randomized 1:1 to']","['metformin vs observation (OBS', 'metformin', 'Metformin']","['CD8 T-cell NCR frequencies', 'CD4 or CD8 T-cells, in the CD4/CD8 ratio, or in activated (CD38+HLA-DR+) CD4 or CD8 T-cells', 'frequencies of T-cell activation (CD38+HLA-DR+) and NCR (programmed cell death protein 1 [PD1], T-cell immunoreceptor with Ig and ITIM domains [TIGIT], and T-cell mucin-domain containing-3 [TIM3', 'frequency of PD1+, PD1+TIGIT+ and PD1+TIGIT+TIM3+ expressing CD4 T-cells', 'CD4 T-Cell Exhaustion']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0005768'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1564881', 'cui_str': 'Apoptosis Regulatory Proteins'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0026682', 'cui_str': 'Mucins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}]",,0.027339,"No differences in 24-week change were seen between arms in CD4 or CD8 T-cells, in the CD4/CD8 ratio, or in activated (CD38+HLA-DR+) CD4 or CD8 T-cells.","[{'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Shikuma', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Glen M', 'Initials': 'GM', 'LastName': 'Chew', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Kohorn', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Souza', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Chow', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Ivo Novita', 'Initials': 'IN', 'LastName': 'SahBandar', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Eun-Young', 'Initials': 'EY', 'LastName': 'Park', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hanks', 'Affiliation': 'Department of Medicine, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Louie Mar A', 'Initials': 'LMA', 'LastName': 'Gangcuangco', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Gerschenson', 'Affiliation': 'Department of Cell and Molecular Biology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Lishomwa C', 'Initials': 'LC', 'LastName': 'Ndhlovu', 'Affiliation': 'Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaii - Manoa, Honolulu, Hawaii.'}]",AIDS research and human retroviruses,['10.1089/AID.2019.0078']
368,32091593,Child-level evaluation of a web-based intervention to improve dietary guideline implementation in childcare centers: a cluster-randomized controlled trial.,"BACKGROUND


Although it is recommended that childcare centers provide foods consistent with dietary guidelines, the impact of implementing sector-specific guidelines on child outcomes is largely unknown.
OBJECTIVES


This study aims to examine the impact of a web-based program and support to implement dietary guidelines in childcare centers on children's 1) diet; 2) BMI z scores; and 3) child health-related quality of life (HRQoL).
METHODS


This study was a cluster-randomized controlled trial utilizing a Type-3 Hybrid implementation-effectiveness design conducted between October 2016 and March 2018. This study reports on child outcomes. Fifty-four childcare centers in New South Wales, Australia were randomly assigned to the intervention (a web-based menu-planning tool and support) or control group (usual care). The intervention was designed to address barriers and enablers to dietary guideline implementation according to the Theoretical Domains Framework. A quota of 35 consenting childcare centers undertook child-level evaluation of dietary intake where 522 parents consented to completing ≥1 component of data collection for their child. Child consumption of core and discretionary (unhealthy) foods while in care was assessed via dietary observations by blinded research assistants, childcare diet quality was assessed via educator-completed questionnaires, BMI z scores were assessed via measured weight and height, and child HRQoL was assessed via parent report at baseline and 12-mo follow-up.
RESULTS


There was a significant increase in mean child consumption of fruit (0.39 servings; 95% CI: 0.12, 0.65 servings) and dairy foods (0.38 servings; 95% CI: 0.19, 0.57 servings) and a significant reduction in consumption of discretionary foods (-0.40 servings; 95% CI: -0.64, -0.16 servings) in care in the intervention group, relative to control at 12-mo follow-up. No significant differences were observed in diet quality, BMI z scores, or HRQoL.
CONCLUSIONS


A web-based intervention to support planning of childcare menus consistent with dietary guidelines can improve child consumption of healthier foods in daycare. This trial was registered at www.anzctr.org.au as ACTRN12616000974404.",2020,"No significant differences were observed in diet quality, BMI z scores, or HRQoL.
CONCLUSIONS


A web-based intervention to support planning of childcare menus consistent with dietary guidelines can improve child consumption of healthier foods in daycare.","['October 2016 and March 2018', 'childcare centers', 'Fifty-four childcare centers in New South Wales, Australia', '35 consenting childcare centers undertook child-level evaluation of dietary intake where 522 parents consented to completing ≥1 component of data collection for their child', ""childcare centers on children's 1) diet; 2""]","['intervention (a web-based menu-planning tool and support) or control group (usual care', 'web-based program and support to implement dietary guidelines', 'web-based intervention to improve dietary guideline implementation']","['consumption of discretionary foods', 'weight and height, and child HRQoL', 'child consumption of healthier foods in daycare', 'mean child consumption of fruit', 'diet quality, BMI z scores', 'BMI z scores; and 3) child health-related quality of life (HRQoL']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.136214,"No significant differences were observed in diet quality, BMI z scores, or HRQoL.
CONCLUSIONS


A web-based intervention to support planning of childcare menus consistent with dietary guidelines can improve child consumption of healthier foods in daycare.","[{'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Stacey', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flood', 'Affiliation': 'Western Sydney Local Health District, Westmead, New South Wales, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Salajan', 'Affiliation': 'Healthy Australia Ltd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': ""O'Rourke"", 'Affiliation': 'Healthy Australia Ltd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Barnes', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pond', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Green', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa025']
369,31552428,Behavioral-educational sleep interventions for pediatric epilepsy: a randomized controlled trial.,"STUDY OBJECTIVES


To evaluate the effect of a clinic-based, behavioral-educational sleep intervention on sleep of children with epilepsy, maternal knowledge about childhood sleep, and maternal sleep quality.
METHODS


A total of 100 toddlers and preschool-age children with epilepsy (1.5-6 years, 55% boys) and their parents were randomized to receive sleep intervention (n = 50) or usual care with attention (n = 50). Outcomes were assessed at baseline, 3, 6, and 12 months after intervention with the use of objective actigraphy, Children's Sleep Habits Questionnaire, Parents' Sleep Knowledge Inventory, and Pittsburgh Sleep Quality Index. Intervention effects were examined using general linear models for repeated measurements to compare the mean change in outcomes from baseline to 12 months post-intervention between the two groups.
RESULTS


Sleep intervention resulted in children having greater sleep efficiency by 2.03% compared with the usual care group (95% CI = 0.20% to 3.86%; p = .03). Children in the intervention group also had significantly longer total nighttime sleep as objectively assessed by actigraphy than did those in the usual care group, with an adjusted mean difference of 16.13 minutes (95% CI = 0.24% to 32.03%; p = .04). No intervention effects were observed for maternal knowledge about childhood sleep, and maternal sleep quality.
CONCLUSION


Sleep intervention provided during routine neurologic visits results in significant, measurable, and sustained benefits in sleep quality and quantity in children with epilepsy. Future trials are warranted to evaluate whether improvements in sleep could impact health-related quality of life or other aspects of functioning in children with epilepsy.
CLINICAL TRIAL


This trial has been registered at www.clinicaltrials.gov (trial name: Sleep Intervention for Pediatric Epilepsy; registration number: NCT02514291).",2020,"RESULTS


Sleep intervention resulted in children having greater sleep efficiency by 2.03% compared with the usual care group (95% CI, 0.20-3.86; P = .03).","['children with epilepsy', 'Pediatric Epilepsy', '100 toddlers and preschool-age children with epilepsy (1.5-6 years, 55% boys) and their parents']","['Behavioral-Educational Sleep Interventions', 'sleep intervention (n=50) or usual care with attention', 'Sleep intervention', 'clinic-based, behavioral-educational sleep intervention']","['maternal knowledge about childhood sleep, and maternal sleep quality.\nCONCLUSION', ""objective actigraphy, Children's Sleep Habits Questionnaire, Parents' Sleep Knowledge Inventory, and Pittsburgh Sleep Quality Index"", 'sleep of children with epilepsy, maternal knowledge about childhood sleep, and maternal sleep quality', 'longer total nighttime sleep', 'sleep quality and quantity', 'sleep efficiency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",100.0,0.121428,"RESULTS


Sleep intervention resulted in children having greater sleep efficiency by 2.03% compared with the usual care group (95% CI, 0.20-3.86; P = .03).","[{'ForeName': 'Shao-Yu', 'Initials': 'SY', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wang-Tso', 'Initials': 'WT', 'LastName': 'Lee', 'Affiliation': ""Department of Pediatric Neurology, National Taiwan University Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Chien-Chang', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Suh-Fang', 'Initials': 'SF', 'LastName': 'Jeng', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Chin', 'Initials': 'WC', 'LastName': 'Weng', 'Affiliation': ""Department of Pediatric Neurology, National Taiwan University Children's Hospital, Taipei, Taiwan.""}]",Sleep,['10.1093/sleep/zsz211']
370,32281095,Investigation of a New Catheter on Relieving Pain During Male Cystoscopy - A Randomized Clinical Trial.,"PURPOSE


To investigate the pain intensity and tolerability of a new catheter applied to urethral surface anesthesia during rigid cystoscopy in male patients, and explore the prospects of its application and the anesthetic method in hospitals at primary levels.
MATERIALS AND METHODS


252 adult male patients were randomly divided into the experimental group and the control group.1% lidocaine solution was irrigated into the posterior urethra of the experimental group using the new catheter before cystoscopy, while the control group was administered with lidocaine gel. Both groups were assessed by visual analogue scale(VAS) with their pain perceived during administration of lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group) (T1),during the insertion of cystoscope (T2),at the beginning of cystoscopy (T3),The third minute of cystoscopy (T4), during the first urination after the procedure (T5), as well with the maximum pain(Pmax) perceived during the whole procedure. The fluctuations of blood pressure and heart rate in each group before, after and during the procedure were recorded, and the anesthesia costs in both groups were calculated.
RESULTS


Except a slightly higher score in T1, the scores of VAS in experimental group were lower than those of control group in T2,T3 and T4. The Pmax of the control group was 4.92(SD=1.20), which was higher than in the experimental group of 3.89(SD=0.95,P<0.01).There was no significant difference on blood pressure variation in both groups. While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups. The anesthesia cost of the experimental group is about 1.53 dollars, with 1.75 dollars lower than that of the control group.
CONCLUSION


It is tolerable and beneficial to apply the new catheter for male urethral anesthesia. It can significantly relieve the pain during rigid cystoscopy in male patients, and is low in cost and easy in operation. Thus this method is worth being recommended to hospitals, especially at community hospitals or primary hospitals.",2020,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","['252 adult male patients', 'male urethral anesthesia', 'male patients']","['New Catheter', 'control group.1% lidocaine solution', 'lidocaine gel', 'new catheter applied to urethral surface anesthesia during rigid cystoscopy', 'lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group']","['scores of VAS', 'heart rate variation', 'anesthesia costs', 'pain intensity and tolerability', 'pain', 'anesthesia cost', 'fluctuations of blood pressure and heart rate', 'blood pressure variation', 'Relieving Pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",252.0,0.0267797,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","[{'ForeName': 'Xiong Yong', 'Initials': 'XY', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China. xiongyongjiang1988@126.com.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Jiaji', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}]",Urology journal,['10.22037/uj.v0i0.5130']
371,32282957,Effect of increased levothyroxine dose on depressive mood in older adults undergoing thyroid hormone replacement therapy.,"OBJECTIVE


Depressive mood consequent to hypothyroidism can be reversed with levothyroxine (LT4) replacement therapy. However, it is unclear whether increasing LT4 dose confers additional mood benefits.
DESIGN AND PATIENTS


A single-blinded before-and-after study of 24 patients with hypothyroidism who were aged 65 years or older and undergoing LT4 replacement therapy with stable doses.
MEASUREMENTS


Geriatric Depression Scale (GDS-K) and Hyperthyroid Symptom Scale (HSS-K) were assessed at baseline, 3 months after increasing LT4 dose by an additional 12.5 µg/d, and finally 3 months after returning to the baseline dose.
RESULTS


Serum thyroid-stimulating hormone (TSH) concentrations decreased at the higher LT4 dose (1.95 ± 2.16 vs 0.47 ± 1.09 mIU/L, P < .001) and recovered after returning to the baseline dose. Serum-free thyroxine levels and HSS-K scores were unchanged during the study period. GDS-K scores improved on the increased dose (9.5 ± 6.6 vs 7.5 ± 4.7, P = .029), and this improvement was maintained after returning to the baseline dose (9.5 ± 6.6 vs 7.4 ± 5.4, P = .010). Higher serum TSH was independently associated with both higher GDS-K and depression risk among those with depressive mood (GDS-K > 10) at baseline.
CONCLUSIONS


Depressive mood improves with increased LT4 dose, without significant hyperthyroid symptoms or signs, in older adults undergoing thyroid hormone replacement. These findings suggest the potential for varying the treatment target for hypothyroidism based on mood status and that low-dose LT4 treatment might be an ancillary treatment for depression.",2020,"Depressive mood improves with increased LT4 dose, without significant hyperthyroid symptoms or signs, in older adults undergoing thyroid hormone replacement.","['24 patients with hypothyroidism who were aged 65 years or older and undergoing LT4 replacement therapy with stable doses', 'older adults undergoing thyroid hormone replacement', 'older adults undergoing thyroid hormone replacement therapy']","['levothyroxine (LT4) replacement therapy', 'levothyroxine']","['Depressive mood', 'Higher serum TSH', 'GDS-K scores', 'Serum-free thyroxine levels and HSS-K scores', 'Geriatric Depression Scale (GDS-K) and Hyperthyroid Symptom Scale (HSS-K', 'depressive mood', 'Serum thyroid-stimulating hormone (TSH) concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2242640', 'cui_str': 'Thyroid hormone replacement therapy'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1269634', 'cui_str': 'Serum free T4 measurement'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",24.0,0.0602373,"Depressive mood improves with increased LT4 dose, without significant hyperthyroid symptoms or signs, in older adults undergoing thyroid hormone replacement.","[{'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Han', 'Affiliation': 'Department of Neuropsychiatry, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Tae Jung', 'Initials': 'TJ', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Ki Woong', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Hak Chul', 'Initials': 'HC', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}]",Clinical endocrinology,['10.1111/cen.14189']
372,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3  antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2']
373,32087795,"Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study.","BACKGROUND


Treatment with tenofovir disoproxil fumarate has been associated with renal toxicity or reductions in bone mineral density, or both, in some patients with chronic hepatitis B virus (HBV) infection. Tenofovir alafenamide is a tenofovir prodrug with high intrahepatic concentrations of active drug and reduced systemic tenofovir exposures compared with tenofovir disoproxil fumarate. In patients with chronic HBV, tenofovir alafenamide has shown efficacy non-inferior to that of tenofovir disoproxil fumarate with improved renal and bone safety. With this non-inferiority study, we aimed to evaluate the efficacy and safety of tenofovir alafenamide in patients with HBV infection switching from tenofovir disoproxil fumarate who are virally suppressed.
METHODS


Patients with chronic HBV infection who had been receiving tenofovir disoproxil fumarate for 48 weeks or more and who had HBV DNA less than the lower limit of quantification (LLOQ) for at least 12 weeks were recruited to this randomised, multicentre, double-blind, phase 3 non-inferiority study. Patients were randomly assigned in a 1:1 ratio to receive tenofovir alafenamide 25 mg once a day or to continue tenofovir disoproxil fumarate 300 mg once a day. The primary efficacy endpoint was loss of virological control, defined as the proportion of patients who received at least one dose of study drug who had HBV DNA of at least 20 IU/mL at week 48 by the modified US Food and Drug Administration (FDA) snapshot algorithm. Key safety endpoints were changes in hip and spine bone mineral density, estimated creatinine clearance by Cockcroft-Gault, and markers of bone turnover and renal tubular function. The study was powered for non-inferiority in efficacy of tenofovir alafenamide versus tenofovir disoproxil fumarate with a 4% margin. Investigators and patients were unaware of treatment allocation and on-treatment results. This trial is ongoing and is registered with ClinicalTrials.gov, number NCT02979613.
FINDINGS


Participants in this study were enrolled between Dec 29, 2016, and Oct 20, 2017. 541 patients were screened and 490 patients were randomly assigned to switch to tenofovir alafenamide or to stay on tenofovir disoproxil fumarate. Two patients assigned to receive tenofovir alafenamide did not receive treatment; thus the full analysis set for efficacy and safety analyses consisted of 243 patients in the tenofovir alafenamide group and 245 in the tenofovir disoproxil fumarate group. At week 48, one patient from each treatment group (both <1%) had HBV DNA of at least 20 IU/mL (difference in proportion 0·0%, 95% CI -1·9 to 2·0), thereby showing non-inferior efficacy of tenofovir alafenamide to tenofovir disoproxil fumarate. Patients who received tenofovir alafenamide had significantly increased bone mineral density at hip (mean change 0·66% [SD 2·08] vs -0·51% [SD 1·91]; difference in least square means 1·17% [95% CI 0·80 to 1·54; p<0·0001]) and at spine (mean change 1·74% [3·46] vs -0·11% [3·13]; difference in least square means 1·85% [1·24 to 2·46; p<0·0001]), creatinine clearance by Cockcroft-Gault relative to tenofovir disoproxil fumarate (median change 0·94 mL/min [IQR -4·47 to 6·24] vs -2·74 mL/min [-7·89 to 1·88]; p <0·0001), and improved markers of bone turnover and tubular function at week 48. The most common treatment-emergent adverse events were upper respiratory tract infection (18 [7%] of 243 patients in the tenofovir alafenamide group and 16 [7%] of 245 patients in the tenofovir disoproxil fumarate group) and nasopharyngitis (13 [5%] of 243 patients in the tenofovir alafenamide group and 12 [5%] of 245 patients in the tenofovir disoproxil fumarate group). The incidence of grade 3 and above adverse events and serious adverse events was low and similar between groups. No viral resistance was observed in patients who qualified for viral sequencing.
INTERPRETATION


These findings suggest that tenofovir alafenamide can be substituted for tenofovir disoproxil fumarate in patients with HBV infection for improved safety without a loss of efficacy.
FUNDING


Gilead Sciences.",2020,"Patients who received tenofovir alafenamide had significantly increased bone mineral density at hip (mean change 0·66% [SD 2·08] vs -0·51% [SD 1·91]; difference in least square means 1·17% [95% CI 0·80 to 1·54; p<0·0001]) and at spine (mean change 1·74% [3·46] vs -0·11% [3·13]; difference in least square means 1·85% [1·24 to 2·46; p<0·0001]), creatinine clearance by Cockcroft-Gault relative to tenofovir disoproxil fumarate (median change 0·94 mL/min [IQR -4·47 to 6·24] vs -2·74 mL/min [-7·89 to 1·88]; p <0·0001), and improved markers of bone turnover and tubular function at week 48.","['patients with HBV infection switching from tenofovir disoproxil fumarate who are virally suppressed', 'Participants in this study were enrolled between Dec 29, 2016, and Oct 20, 2017', 'for 48 weeks or more and who had HBV DNA less than the lower limit of quantification (LLOQ) for at least 12 weeks', 'patients with chronic hepatitis B virus (HBV) infection', 'patients who qualified for viral sequencing', 'patients with HBV infection', 'Patients with chronic HBV infection who had been receiving', '541 patients were screened and 490 patients', 'virologically suppressed patients with chronic hepatitis B']","['tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate to tenofovir alafenamide', 'tenofovir alafenamide to tenofovir disoproxil fumarate', 'tenofovir alafenamide versus tenofovir disoproxil fumarate', 'tenofovir alafenamide', 'tenofovir alafenamide group and 245 in the tenofovir disoproxil fumarate group', 'Tenofovir alafenamide', 'tenofovir alafenamide or to stay on tenofovir disoproxil fumarate', 'tenofovir alafenamide 25 mg once a day or to continue tenofovir disoproxil fumarate']","['HBV DNA', 'efficacy and safety', 'hip and spine bone mineral density, estimated creatinine clearance by Cockcroft-Gault, and markers of bone turnover and renal tubular function', 'bone mineral density', 'viral resistance', 'loss of virological control', 'nasopharyngitis', 'markers of bone turnover and tubular function', 'incidence of grade 3 and above adverse events and serious adverse events', 'renal and bone safety', 'creatinine clearance by Cockcroft-Gault relative to tenofovir disoproxil fumarate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0487717', 'cui_str': 'Viral Sequencing'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C4293420', 'cui_str': 'tenofovir alafenamide 25 MG [Vemlidy]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0520989', 'cui_str': 'Viral resistance, function (observable entity)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]",541.0,0.207175,"Patients who received tenofovir alafenamide had significantly increased bone mineral density at hip (mean change 0·66% [SD 2·08] vs -0·51% [SD 1·91]; difference in least square means 1·17% [95% CI 0·80 to 1·54; p<0·0001]) and at spine (mean change 1·74% [3·46] vs -0·11% [3·13]; difference in least square means 1·85% [1·24 to 2·46; p<0·0001]), creatinine clearance by Cockcroft-Gault relative to tenofovir disoproxil fumarate (median change 0·94 mL/min [IQR -4·47 to 6·24] vs -2·74 mL/min [-7·89 to 1·88]; p <0·0001), and improved markers of bone turnover and tubular function at week 48.","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Lampertico', 'Affiliation': 'CRC ""A M and A Migliavacca"" Center for Liver Disease, Division of Gastroenterology and Hepatology, Foundation IRCCS Cà Granda Ospedale, Maggiore Policlinico, University of Milan, Milan, Italy. Electronic address: pietro.lampertico@unimi.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Hospital General Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Fung', 'Affiliation': 'Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Yongsei University, Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Wan-Long', 'Initials': 'WL', 'LastName': 'Chuang', 'Affiliation': 'Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Tak', 'Affiliation': 'School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Alnoor', 'Initials': 'A', 'LastName': 'Ramji', 'Affiliation': 'Gastrointestinal Research Institute, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Chi-Yi', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Chiayi Christian Hospital, Chiayi City, Taiwan.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'LAIR Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Bae', 'Affiliation': 'Asian Pacific Liver Center, Los Angeles, CA, USA.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Hahnemann University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Flaherty', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lau', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Vithika', 'Initials': 'V', 'LastName': 'Suri', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Susanna K', 'Initials': 'SK', 'LastName': 'Tan', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Huy', 'Initials': 'H', 'LastName': 'Trinh', 'Affiliation': 'Silicon Valley Research Institute, San Jose, CA, USA.'}, {'ForeName': 'Seung-Kew', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': 'Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': 'Kings College Hospital, London, UK.'}, {'ForeName': 'Young-Suk', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Henry L Y', 'Initials': 'HLY', 'LastName': 'Chan', 'Affiliation': 'The Chinese University of Hong Kong, China.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30421-2']
374,32282787,"The Use of a Novel, Nonsurgical Bone Conduction Hearing Aid System for the Treatment of Conductive Hearing Loss.","OBJECTIVE


Conventional bone conduction hearing aid solutions often require a cumbersome retention system such as a headband or cap. This study aims to determine if a novel, nonsurgical bone conduction aid utilizing an adhesive attachment over the mastoid is equivalent to the conventional bone conduction hearing aid (BCHA) for the management of conductive hearing loss.
STUDY DESIGN


Prospective, single-subject randomized, crossover trial.
SETTING


Tertiary referral center.
PATIENTS


Eleven adults and 1 child between 11 and 70 years of age with unilateral conductive hearing loss were enrolled.
INTERVENTION


Patients had their baseline hearing assessed and were randomized to receive either the novel device or BCHA headband system. Hearing loss etiologies were varied and included cholesteatoma, otosclerosis, chronic otitis media, and previous head and neck surgery. Patients had their baseline hearing assessed and trialled both the novel device or the BCHA headband system. Patients were randomly assigned one device which was worn for 2 weeks followed by a 2-week trial with the alternate device.
MAIN OUTCOME MEASURE


Pure-tone thresholds and speech discrimination in quiet and noise were tested and patients also completed the short form of the Speech Spatial and Quality of Hearing (SSQ) questionnaire.
RESULTS


The mean unaided 4 frequency pure-tone average (PTA) air conduction threshold was 53.9 dB, bone conduction was 11.9 dB, and the mean air bone gap was 42 dB in the target ear. One patient with an adhesive skin reaction could not complete the protocol. Aided PTA and threshold testing between 250 Hz to 8000 Hz showed statistically equivalent results between both devices. The aided CNC word score, signal-to-noise ratio, and SSQ scores were also equivalent between both devices.
CONCLUSION


The novel bone conduction aid demonstrates equivalent performance to the conventional BCHA headband solution. The novel device should be considered an alternative option where the cosmetic and comfort issues of a headband worn device are a concern.",2020,"The aided CNC word score, signal-to-noise ratio, and SSQ scores were also equivalent between both devices.
","['Tertiary referral center', 'Conductive Hearing Loss', 'Eleven adults and 1 child between 11 and 70 years of age with unilateral conductive hearing loss were enrolled', 'Patients had their baseline hearing assessed and trialled both the novel device or the BCHA headband system']","['conventional bone conduction hearing aid (BCHA', 'novel device or BCHA headband system']","['Speech Spatial and Quality of Hearing (SSQ) questionnaire', 'aided CNC word score, signal-to-noise ratio, and SSQ scores', 'mean unaided 4 frequency pure-tone average (PTA) air conduction threshold', 'mean air bone gap', 'Hearing loss etiologies']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1955772', 'cui_str': 'Unilateral conductive hearing loss'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0453975', 'cui_str': 'Headband'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0493535', 'cui_str': 'Bone-conduction hearing aid'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0453975', 'cui_str': 'Headband'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0406810', 'cui_str': 'Carney complex'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0234744', 'cui_str': 'Air conduction'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",11.0,0.0471179,"The aided CNC word score, signal-to-noise ratio, and SSQ scores were also equivalent between both devices.
","[{'ForeName': 'Jafri', 'Initials': 'J', 'LastName': 'Kuthubutheen', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Broadbent', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Marino', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}, {'ForeName': 'Dayse', 'Initials': 'D', 'LastName': 'Távora-Vieira', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002657']
375,31591903,Effectiveness of an 8-Week Aerobic Exercise Program on Autonomic Function in People Living with HIV Taking Anti-Retroviral Therapy: A Pilot Randomized Controlled Trial.,"This study assessed the effectiveness of an 8-week aerobic exercise program on heart rate variability (HRV) in people living with HIV taking antiretroviral therapy. Twenty-six participants were randomly assigned to a control group or an aerobic exercise group. Resting HRV was measured for 5 min in supine position using an electrocardiogram. Estimated maximal oxygen uptake (VO 2max ) was assessed through a treadmill 6-min walk test. The training program consisted of aerobic exercise thrice per week at 65%-75% of heart rate max for 45 min per session. Repeated measures ANOVA was used to test for differences between groups, and Spearman's rho was used to assess for the correlation between HRV measures and estimated VO 2max . There was no significant group by time interactions for any of the HRV indices. However, the standard deviation of normal-to-normal (NN) R-R intervals increased significantly in the aerobic exercise group (pre: 46.97 ± 32.70 ms vs. post: 59.49 ± 37.20 ms,  p  = .045). There was a strong correlation between the VO 2max  and the standard deviation of NN intervals (SDNN) ( r  = 0.617;  p  = .002). There was a moderate correlation between VO 2max  and the square root of the mean squared differences of successive normal-to-normal intervals (rMSSD) ( r  = 0.424;  p  = .049), the low frequency power ( r  = 0.506;  p  = .016), and the standard deviation of differences between successive differences of normal-to-normal intervals (SDSD) ( r  = 0.424;  p  = .049). While differences in HRV were not observed between groups, our data suggest that overall autonomic function can improve across time with aerobic exercise, and these changes are associated with greater levels of VO 2max . These results advocate the importance of improvements in HRV given their association with lower risk of cardiovascular disease and mortality.",2020,There were no significant group by time interactions for any of the HRV indices.,"['people living with HIV taking anti-retroviral therapy (ART', 'people living with HIV taking Anti-retroviral therapy', 'Twenty-six participants']","['aerobic exercise', 'aerobic exercise program', 'control group or an aerobic exercise group']","['autonomic function', 'heart rate variability (HRV', 'HRV', 'standard deviation of normal-to-normal (NN) R-R intervals', 'Estimated maximal oxygen uptake (VO2max', 'levels of VO2max', 'Resting HRV']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",26.0,0.110683,There were no significant group by time interactions for any of the HRV indices.,"[{'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Quiles', 'Affiliation': 'Department of Family, Nutrition and Exercise Sciences, Queens College of the City University of New York, Flushing, New York.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'School of Physical Therapy, University of the Incarnate Word, San Antonio, Texas.'}]",AIDS research and human retroviruses,['10.1089/AID.2019.0194']
376,32279227,Efficacy of Postbiotics in a PRP-Like Cosmetic Product for the Treatment of Alopecia Area Celsi: A Randomized Double-Blinded Parallel-Group Study.,"INTRODUCTION


Alopecia areata (AA), also known as 'area Celsi', is the second most common form of hair loss affecting the scalp. Newly proposed treatments for AA include low-level light therapy, biologics such as Janus kinase inhibitors and autologous platelet-rich plasma (PRP), which is a well-known ""elixir"" for hair growth. Bioactive peptides developed through biotechnological applications have been used to overcome the limitations of PRP. More recently, the involvement of microbiota in hair growth disorders, in AA in particular, has been reported, and the usefulness of microbial metabolites, i.e. postbiotics, has been suggested.
METHODS


This study was a randomized double-blinded parallel-group study in which 160 persons of both sexes affected by AA and aged between 18 and 60 years were enrolled. The subjects were randomly assigned to a treatment group (group 1), receiving the TR-PRP plus-Celsi cosmetic product, and a placebo group (group 2). The SALT (Severity of Alopecia Tool) score was determined in both groups at baseline and after 2 and 3 months of treatment, and the results compared between groups.
RESULTS


The subjects in group 1 showed a significant change from baseline in SALT score at 2 months of treatment (61.04% ± 3.45%; p < 0.0001), with a further improvement at the end of treatment (3 months) (69.56% ± 4.32%; p < 0.0001). No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
CONCLUSIONS


The results of this study provide further proof of the efficacy of bioactive peptides that mimick the growth factors present in PRP in subjects affected by AA. They also add to our knowledge of the link between microbiota and hair growth disorders, emphasizing the importance of studies on the microbial community and microbial metabolites as a novel therapeutic approach.",2020,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","['Alopecia Area Celsi', '160 persons of both sexes affected by AA and aged between 18 and 60\xa0years were enrolled']","['Postbiotics', 'PRP-Like Cosmetic Product', 'TR-PRP plus-Celsi cosmetic product, and a placebo']","['SALT (Severity of Alopecia Tool) score', 'SALT score']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.108524,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy. fabio.rinaldi@studiorinaldi.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trink', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}]",Dermatology and therapy,['10.1007/s13555-020-00369-9']
377,31243451,Effect of belimumab on proteinuria and anti-phospholipase A2 receptor autoantibody in primary membranous nephropathy.,"BACKGROUND


Immunosuppressant drugs reduce proteinuria and anti-phospholipase A2 receptor autoantibodies (PLA2R-Ab) in primary membranous nephropathy (PMN) with varying success and associated toxicities. This study aimed to evaluate the effect of belimumab on proteinuria and PLA2R-Ab in participants with PMN.
METHODS


In this prospective, open-label, experimental medicine study, 14 participants with PMN and persistent nephrotic-range proteinuria received up to 2 years belimumab monotherapy (10 mg/kg, every 4 weeks). Changes in proteinuria (urinary protein:creatinine ratio), PLA2R-Ab, albumin, cholesterol, B-cell subsets and pharmacokinetics were analysed during treatment and up to 6 months after treatment.
RESULTS


Eleven participants completed to the primary endpoint (Week 28) and nine participants completed the study. In the intention-to-treat population population, baseline proteinuria of 724 mg/mmol [95% confidence interval (CI) 579-906] decreased to 498 mg/mmol (95% CI 383-649) and 130 mg/mmol (95% CI 54-312) at Weeks 28 and 104, respectively, with changes statistically significant from Week 36 (n = 11, P = 0.047). PLA2R-Ab decreased from 174 RU/mL (95% CI 79-384) at baseline to 46 RU/mL (95% CI 16-132) and 4 RU/mL (95% CI 2-6) at Weeks 28 and 104, respectively, becoming statistically significant by Week 12 (n = 13, P = 0.02). Nine participants achieved partial (n = 8) or complete (n = 1) remission. Participants with abnormal albumin and/or cholesterol at baseline gained normal/near normal levels by the last follow-up. Adverse events were consistent with those expected in this population.
CONCLUSIONS


Belimumab treatment in participants with PMN can reduce PLA2R-Ab and subsequently proteinuria, important preludes to remission induction.",2020,PLA2R-Ab decreased from 174 RU/mL (95% CI 79-384) at baseline to 46 ,"['primary membranous nephropathy (PMN', '14 participants with PMN and persistent nephrotic-range proteinuria received up to 2\u2009years', 'Participants with abnormal albumin and/or cholesterol at baseline gained normal/near normal levels by the last follow-up', 'primary membranous nephropathy', 'Eleven participants completed to the primary endpoint (Week 28) and nine participants completed the study', 'participants with PMN']","['belimumab monotherapy', 'belimumab']","['Adverse events', 'proteinuria (urinary protein:creatinine ratio), PLA2R-Ab, albumin, cholesterol, B-cell subsets and pharmacokinetics', 'PLA2R-Ab']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0017665', 'cui_str': 'Membranous Glomerulonephropathy'}, {'cui': 'C0445118', 'cui_str': 'Nephrotic range proteinuria (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0079004', 'cui_str': 'B-Cell Subsets'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",14.0,0.170262,PLA2R-Ab decreased from 174 RU/mL (95% CI 79-384) at baseline to 46 ,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Barrett', 'Affiliation': 'Experimental Medicine Unit, GlaxoSmithKline R&D, UK.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Willcocks', 'Affiliation': ""Renal Unit, Addenbrooke's Hospital, UK.""}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': ""Renal Unit, Addenbrooke's Hospital, UK.""}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Tarzi', 'Affiliation': 'Experimental Medicine Unit, GlaxoSmithKline R&D, UK.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Henderson', 'Affiliation': 'Experimental Medicine Unit, GlaxoSmithKline R&D, UK.'}, {'ForeName': 'Gengqian', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Quantitative Sciences, GlaxoSmithKline R&D, USA.'}, {'ForeName': 'Sophie I', 'Initials': 'SI', 'LastName': 'Gisbert', 'Affiliation': 'GlaxoSmithKline R&D, UK.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Belson', 'Affiliation': 'Experimental Medicine Unit, GlaxoSmithKline R&D, UK.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Savage', 'Affiliation': 'Experimental Medicine Unit, GlaxoSmithKline R&D, UK.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz086']
378,32277343,Comparison of Two Different Treat-and-Extend Protocols with Aflibercept in Wet Age-Related Macular Degeneration: Two-Year Results.,"INTRODUCTION


To optimize the aflibercept treat-and-extend protocol in wet age-related macular degeneration (wAMD) beyond the 1-year interim report.
METHODS


This 2-year prospective randomized clinical trial included 52 eyes from 52 patients with treatment-naïve wAMD. After the induction phase of three monthly aflibercept injections, patients were randomized 1:1 to two different treat-and-extend protocols. In the treat-and-extend protocol with moderate extensions (T&Em), the treatment interval was extended 1 week at a time up to 12 weeks, and then by 2 weeks up to 16 weeks. In the treat-and-extend protocol with rapid extensions (T&Er), the treatment interval was initially extended to 8 weeks, and then by 2 weeks up to 16 weeks. Main outcome measure was the number of given aflibercept injections.
RESULTS


At the study end point at 2 years, the mean visual gain from the baseline was 7.9 ± 14.5 letters in T&Em, compared to 10.8 ± 16.5 letters in T&Er protocol (P = 0.726). The mean decrease in central subfield macular thickness was 203.0 ± 167.4 µm in T&Em and 192.3 ± 160.2 µm in T&Er protocol (P = 0.822). Treatment interval was 10.3 ± 3.3 weeks in T&Em and 11.7 ± 3.5 in T&Er protocol (P = 0.164) at the end of year 2. The total number of injections in 2 years was 14.1 ± 3.1 in T&Em and 11.6 ± 2.0 in T&Er (P = 0.002), and the number of injections during the second year was 5.4 ± 1.8 and 4.4 ± 1.4, respectively (P = 0.043). A total of 71% of the eyes in both treatment groups had a dry macula at the study end point.
CONCLUSIONS


At 2 years, the anatomical and functional responses between the two treatment groups were similar. However, the number of given aflibercept injections was smaller in the rapid extensions protocol.
TRIAL REGISTRATION


EU Clinical Trials Register Number, 2015-001394-41/FI.",2020,The mean decrease in central subfield macular thickness was 203.0 ± 167.4 µm in T&Em and 192.3 ± ,"['Wet Age-Related Macular Degeneration', '52 eyes from 52 patients with treatment-naïve wAMD']",['Aflibercept'],"['central subfield macular thickness', 'anatomical and functional responses', 'mean visual gain', 'number of given aflibercept injections', 'total number of injections', 'dry macula']","[{'cui': 'C3888896', 'cui_str': 'Wet age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0227662', 'cui_str': 'Structure of macula densa'}]",52.0,0.0685762,The mean decrease in central subfield macular thickness was 203.0 ± 167.4 µm in T&Em and 192.3 ± ,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Taipale', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Juha-Matti', 'Initials': 'JM', 'LastName': 'Lindholm', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Kaarniranta', 'Affiliation': 'Department of Ophthalmology, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Tuuminen', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki, Helsinki, Finland. raimo.tuuminen@helsinki.fi.'}]",Advances in therapy,['10.1007/s12325-020-01312-2']
379,32277344,Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock.,"INTRODUCTION


The present study aimed to compare the pharmacokinetic/pharmacodynamic (PK/PD) parameters of imipenem administered by two-step (50% delivered in a 30-min bolus, 50% for the following 90 min) or extended (administered continuously for 2 h) infusion.
METHODS


Patients with sepsis and septic shock were prospectively enrolled and randomized into four groups. Subjects in the two-step or extended groups were given two doses of imipenem (0.5 g q6h and 1.0 g q8h). The plasma imipenem concentrations were measured at given time points after the fifth dose. The PK/PD target was defined as the achievement of a fractional time above the minimal inhibitory concentration (MIC) of > 40%.
RESULTS


Thirty-five patients were eventually enrolled. No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05). All four groups achieved 40% T > MIC when MIC was 0.5-4.0 μg/ml, but only regimens with a higher dose (1.0 g q8h) achieved target when MIC was 8 μg/ml.
CONCLUSION


The two-step and extended regimens of imipenem are comparable to the PK/PD target in the treatment of sepsis and septic shock. A higher dose (1.0 g q8h) should be considered for target achievement at an MIC of > 8 μg/ml.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02616354.",2020,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","['Patients with Sepsis and Septic Shock', 'Patients with sepsis and septic shock', 'Thirty-five patients were eventually enrolled']","['Imipenem', 'imipenem']","['plasma imipenem concentrations', 'pharmacokinetic/pharmacodynamic (PK/PD) parameters', 'percentage of patients achieving 40% T\u2009>\u2009MIC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",35.0,0.14188,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","[{'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Pharmacy Department, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. yiyiyang2004@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01339-5']
380,32277388,Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.,"INTRODUCTION


Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia.
METHODS


In this randomized double-blind study, patients aged ≥ 18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp.
RESULTS


All screened patients (N = 100) were enrolled and randomized to TP (n = 33), RP1 (n = 33), or RP2 (n = 34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
CONCLUSIONS


Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations.
TRIAL REGISTRATION


Clinical Trial Registry of India; CTRI/2018/11/016431.",2020,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","['Indian men with androgenetic alopecia', 'men with androgenetic alopecia who are sensitive to alcoholic formulations', 'Patients with androgenetic alopecia treated with', 'All screened patients (N\u2009=\u2009100', '18\xa0years with androgenetic alopecia', 'patients aged\u2009≥', 'Indian Men']","['minoxidil', 'alcohol-based minoxidil topical solutions', 'TP', 'Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions', 'minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in']","['hydration and reduced redness of the scalp', 'mean (SD) score for redness', 'mean score of scaling', 'mean hydration, mean redness, and mean scaling on scalp', 'mean (SD) hydration', 'Androgenetic Alopecia']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0332324', 'cui_str': 'Sensitive'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]",100.0,0.0681424,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Dermatology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Vartak', 'Affiliation': 'C.L.A.I.M.S. Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Nikhil Kumar', 'Initials': 'NK', 'LastName': 'Kursam', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Amey', 'Initials': 'A', 'LastName': 'Mane', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Sujeet Narayan', 'Initials': 'SN', 'LastName': 'Charugulla', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India. sujeetnc@drreddys.com.""}]",Dermatology and therapy,['10.1007/s13555-020-00374-y']
381,32073956,Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial.,"PURPOSE


A phase II study (ClinicalTrials.gov identifier: NCT00628251) showed activity of olaparib capsules versus pegylated liposomal doxorubicin in patients with germline BRCA-mutated platinum-resistant or partially platinum-sensitive relapsed ovarian cancer. We conducted a phase III trial (SOLO3) of olaparib tablets versus nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.
PATIENTS AND METHODS


In this randomized, open-label trial, patients were randomly assigned 2:1 to olaparib 300 mg twice a day or physician's choice single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan). The primary end point was objective response rate (ORR) in the measurable disease analysis set assessed by blinded independent central review (BICR). The key secondary end point was progression-free survival (PFS) assessed by BICR in the intent-to-treat population.
RESULTS


Of 266 randomly assigned patients, 178 were assigned to olaparib and 88 to chemotherapy. In patients with measurable disease (olaparib, n = 151; chemotherapy, n = 72), the BICR-assessed ORR was significantly higher with olaparib than with chemotherapy (72.2%  v  51.4%; odds ratio [OR], 2.53 [95% CI, 1.40 to 4.58];  P  = .002). In the subgroup who had received 2 prior lines of treatment, the ORR was 84.6% with olaparib and 61.5% with chemotherapy (OR, 3.44 [95% CI, 1.42 to 8.54]). BICR-assessed PFS also significantly favored olaparib versus chemotherapy (hazard ratio, 0.62 [95% CI, 0.43 to 0.91];  P  = .013; median, 13.4  v  9.2 months). Adverse events were consistent with the established safety profiles of olaparib and chemotherapy.
CONCLUSION


Olaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.",2020,Olaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.,"['266 randomly assigned patients', 'patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy', 'patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of', 'patients with germline BRCA-mutated platinum-resistant or partially platinum-sensitive relapsed ovarian cancer', 'Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3']","['platinum-based chemotherapy', 'Olaparib Versus Nonplatinum Chemotherapy', 'olaparib tablets versus nonplatinum chemotherapy', 'olaparib capsules versus pegylated liposomal doxorubicin', 'nonplatinum chemotherapy', ""olaparib 300 mg twice a day or physician's choice single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan""]","['BICR-assessed ORR', 'ORR', 'progression-free survival (PFS) assessed by BICR', 'central review (BICR', 'BICR-assessed PFS', 'ORR and PFS', 'Adverse events', 'objective response rate (ORR']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.196593,Olaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.,"[{'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Harvard Medical School and Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ricardo Villalobos', 'Initials': 'RV', 'LastName': 'Valencia', 'Affiliation': 'Centro Medico Dalinde, Mexico City, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': 'First Faculty of Medicine, Charles University and General University, Prague, Czech Republic.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca and IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Leath', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Bidziński', 'Affiliation': 'Faculty of Medicine and Health Sciences, Jan Kochanowski University, Kielce, Poland.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Nam', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Madry', 'Affiliation': 'Medical University K. Marcinkowski and Clinical Hospital of the Transfiguration, Poznań, Poland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Hernández', 'Affiliation': 'Oaxaca Site Management Organization, Oaxaca de Juarez, Mexico.'}, {'ForeName': 'Paulo A R', 'Initials': 'PAR', 'LastName': 'Mora', 'Affiliation': 'Instituto COI de Educação e Pesquisa, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sang Young', 'Initials': 'SY', 'LastName': 'Ryu', 'Affiliation': 'Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.'}, {'ForeName': 'Tsveta', 'Initials': 'T', 'LastName': 'Milenkova', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Lowe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Università Cattolica del Sacro Cuore-Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02745']
382,31870756,Comparing 6-minute walk versus treadmill walking distance as outcomes in randomized trials of peripheral artery disease.,"BACKGROUND


Randomized trials of people with peripheral artery disease (PAD) and intermittent claudication have traditionally used maximal treadmill walking distance as the primary outcome, but the 6-minute walk test is increasingly used as a primary outcome in randomized trials of PAD. This study compared relative changes in maximal treadmill walking distance versus 6-minute walk distance in response to a therapeutic intervention or control in randomized trials of participants with PAD.
METHODS


Data from four randomized trials of therapeutic interventions in participants with PAD that measured both 6-minute walk and treadmill walking performance at baseline and the 6-month follow-up were combined. Two trials studied supervised treadmill exercise, one studied home-based walking exercise, and one studied resveratrol.
RESULTS


Of 467 participants (mean age, 69.8; standard deviation, 9.7), the mean ankle-brachial index was 0.66 (standard deviation, 0.17). At the 6-month follow-up, participants with PAD randomized to control or placebo significantly declined in 6-minute walk distance (-10.2 m; 95% confidence interval, -18.2 to -2.2; P = .013), but improved maximal treadmill walking distance (+25.7 m; 95% CI, +6.0 to +45.3 m; P = .010; difference between change in 6-minute walk versus maximal treadmill walking distance: -37.3 m; 95% CI, -56.4 to -18.2; P < .001). Home-based exercise improved the 6-minute walk distance by 43.2 m (95% CI, +28.4 to +57.9), and supervised treadmill exercise improved the 6-minute walk distance by 25.0 m (95% CI, +14.7 to +35.2; mean difference, +18.2 m favoring home-based exercise [95% CI, +0.2 to +36.2 m; P = .048]). Among all participants, the presence (vs absence) of treadmill exercise training was associated with a 141.3-m greater improvement in maximal treadmill walking distance compared to 6-minute walk distance (95% CI, 88.2-194.4; P < .001), suggesting a benefit from treadmill training on the treadmill outcome.
CONCLUSIONS


Maximal treadmill walking distance and the 6-minute walk distance are not interchangeable outcomes in participants with PAD. Participants with PAD randomized to control groups improved treadmill walking distance but simultaneously meaningfully declined in 6-minute walk distance. Supervised treadmill exercise training amplified improvement in treadmill walking distance because of a training to the outcome measure phenomenon.",2020,"Home-based exercise improved the 6-minute walk distance by 43.2 m (95% CI, +28.4 to +57.9), and supervised treadmill exercise improved the 6-minute walk distance by 25.0 m (95% CI, +14.7 to +35.2; mean difference, +18.2 m favoring home-based exercise [95% CI, +0.2 to +36.2 m; P = .048]).","['Of 467 participants (mean age, 69.8; standard deviation, 9.7', 'participants with PAD', 'participants with PAD that measured both', 'people with peripheral artery disease (PAD) and intermittent claudication']","['supervised treadmill exercise', 'placebo', 'treadmill exercise training', 'supervised treadmill exercise, one studied home-based walking exercise, and one studied resveratrol', '6-minute walk versus treadmill walking distance', 'Supervised treadmill exercise training', 'maximal treadmill walking distance versus 6-minute walk distance']","['6-minute walk and treadmill walking performance', 'maximal treadmill walking distance', 'treadmill walking distance', 'mean ankle-brachial index', '6-minute walk distance']","[{'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}]",467.0,0.325181,"Home-based exercise improved the 6-minute walk distance by 43.2 m (95% CI, +28.4 to +57.9), and supervised treadmill exercise improved the 6-minute walk distance by 25.0 m (95% CI, +14.7 to +35.2; mean difference, +18.2 m favoring home-based exercise [95% CI, +0.2 to +36.2 m; P = .048]).","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill; Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill. Electronic address: mdm608@northwestern.edu.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology, University of Maryland, Baltimore, Md.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Palo Alto, Calif.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Tamar S', 'Initials': 'TS', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Melina R', 'Initials': 'MR', 'LastName': 'Kibbe', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Criqui', 'Affiliation': 'Department of Family Medicine and Public Health, University of California at San Diego, San Diego, Calif.'}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Conte', 'Affiliation': 'Division of Endovascular and Vascular Surgery, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Domanchuk', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sufit', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, Fla.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ferrucci', 'Affiliation': 'Intramural Research Program, National Institute on Aging, Baltimore, Md.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.05.058']
383,31899287,The neural processes of acquiring placebo effects through observation.,"Learning through social observation is critical for humans. The present study investigates the neural processes underlying the acquisition of placebo effects through observational learning. We created a new functional magnetic resonance imaging (fMRI) paradigm where participants (n ​= ​38, healthy, both sexes) observed a demonstrator experiencing pain relief by a placebo treatment cream and experiencing pain without a treatment (control cream), and subsequently performed the same procedure themselves. Participants demonstrated placebo hypoalgesia while they performed the procedure themselves, confirming that observational learning can lead to placebo effects. During the observational learning phase, fMRI analysis showed a modulation of the amygdalae, periaqueductal grey, temporoparietal junctions (TPJ), and dorsolateral prefrontal cortex (DLPFC). Connectivity between the DLPFC and TPJ during the observational learning task was modulated by the placebo treatment and predicted subsequent placebo effects. Mediation analysis further confirmed that the DLPFC-TPJ connectivity formally mediated the effect of the observed treatment condition on subsequent placebo effects. Additionally, pre-recorded resting state connectivity between the DLPFC and TPJ also predicted observationally-learned placebo effects. Our findings provide an understanding of the neural processes during the acquisition of placebo effects through observation and indicate a critical role for DLPFC-TPJ integration processes during observational learning of therapeutic outcomes.",2020,Connectivity between the DLPFC and TPJ during the observational learning task was modulated by the placebo treatment and predicted subsequent placebo effects.,"['participants (n\u202f=\u202f38, healthy, both sexes) observed a demonstrator experiencing pain relief by a']","['placebo', 'placebo treatment cream and experiencing pain without a treatment (control cream', 'functional magnetic resonance imaging (fMRI) paradigm']","['modulation of the amygdalae, periaqueductal grey, temporoparietal junctions (TPJ), and dorsolateral prefrontal cortex (DLPFC']","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0335296', 'cui_str': 'Demonstrator (occupation)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]",,0.241308,Connectivity between the DLPFC and TPJ during the observational learning task was modulated by the placebo treatment and predicted subsequent placebo effects.,"[{'ForeName': 'Lieven A', 'Initials': 'LA', 'LastName': 'Schenk', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, USA. Electronic address: lieven.schenk@social.mpg.de.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, USA; Departments of Anesthesiology and Psychiatry, School of Medicine, University of Maryland, Baltimore, USA; Center to Advance Chronic Pain Research, University of Maryland, Baltimore, USA. Electronic address: colloca@umaryland.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2019.116510']
384,31466614,Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery.,"BACKGROUND


Patients with acute coronary syndrome (ACS) and history of coronary artery bypass grafting (CABG) are at high risk for recurrent cardiovascular events and death.
OBJECTIVES


This study sought to determine the clinical benefit of adding alirocumab to statins in ACS patients with prior CABG in a pre-specified analysis of ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab).
METHODS


Patients (n = 18,924) 1 to 12 months post-ACS with elevated atherogenic lipoprotein levels despite high-intensity statin therapy were randomized to alirocumab or placebo subcutaneously every 2 weeks. Median follow-up was 2.8 years. The primary composite endpoint of major adverse cardiovascular events (MACE) comprised coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint. Patients were categorized by CABG status: no CABG (n = 16,896); index CABG after qualifying ACS, but before randomization (n = 1,025); or CABG before the qualifying ACS (n = 1,003).
RESULTS


In each CABG category, hazard ratios (95% confidence intervals) for MACE (no CABG 0.86 [0.78 to 0.95], index CABG 0.85 [0.54 to 1.35], prior CABG 0.77 [0.61 to 0.98]) and death (0.88 [0.75 to 1.03], 0.85 [0.46 to 1.59], 0.67 [0.44 to 1.01], respectively) were consistent with the overall trial results (0.85 [0.78 to 0.93] and 0.85 [0.73 to 0.98], respectively). Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [-2.3% to 4.0%], prior CABG 6.4% [0.9% to 12.0%]) and for death (0.4% [-0.1% to 1.0%], 0.5% [-1.9% to 2.9%], and 3.6% [0.0% to 7.2%]).
CONCLUSIONS


Among patients with recent ACS and elevated atherogenic lipoproteins despite intensive statin therapy, alirocumab was associated with large absolute reductions in MACE and death in those with CABG preceding the ACS event. (ODYSSEY OUTCOMES: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402).",2019,"Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [","['Acute Coronary Syndrome', 'ACS patients with prior CABG', 'Patients (n\xa0', 'Patients were categorized by CABG status', 'Patients with acute coronary syndrome (ACS) and history of coronary artery bypass grafting (CABG']","['Alirocumab', 'alirocumab to statins', 'alirocumab or placebo']","['index CABG', 'atherogenic lipoprotein levels', 'CABG categories for MACE', 'Cardiovascular Events', 'major adverse cardiovascular events (MACE) comprised coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization', 'death', 'hazard ratios', 'Absolute risk reductions']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1275842', 'cui_str': 'Past history of coronary artery bypass grafting'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.0698925,"Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [","[{'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada and St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. Electronic address: goodmans@smh.ca.""}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, New York.'}, {'ForeName': 'Vakhtang', 'Initials': 'V', 'LastName': 'Chumburidze', 'Affiliation': 'Chapidze Emergency Cardiology Center, Tbilisi, Georgia.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Sasko', 'Initials': 'S', 'LastName': 'Kedev', 'Affiliation': 'University Clinic of Cardiology, Skopje, Macedonia.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Angele', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York.'}, {'ForeName': 'Gabriel Arturo', 'Initials': 'GA', 'LastName': 'Ramos López', 'Affiliation': 'Medical Office, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Margus', 'Initials': 'M', 'LastName': 'Viigimaa', 'Affiliation': 'SA Põhja-Eesti Regionaalhaigla, Tallinn, Estonia.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.015']
385,30779528,Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults.,"BACKGROUND


Hypoxemia is the most common complication during tracheal intubation of critically ill adults and may increase the risk of cardiac arrest and death. Whether positive-pressure ventilation with a bag-mask device (bag-mask ventilation) during tracheal intubation of critically ill adults prevents hypoxemia without increasing the risk of aspiration remains controversial.
METHODS


In a multicenter, randomized trial conducted in seven intensive care units in the United States, we randomly assigned adults undergoing tracheal intubation to receive either ventilation with a bag-mask device or no ventilation between induction and laryngoscopy. The primary outcome was the lowest oxygen saturation observed during the interval between induction and 2 minutes after tracheal intubation. The secondary outcome was the incidence of severe hypoxemia, defined as an oxygen saturation of less than 80%.
RESULTS


Among the 401 patients enrolled, the median lowest oxygen saturation was 96% (interquartile range, 87 to 99) in the bag-mask ventilation group and 93% (interquartile range, 81 to 99) in the no-ventilation group (P = 0.01). A total of 21 patients (10.9%) in the bag-mask ventilation group had severe hypoxemia, as compared with 45 patients (22.8%) in the no-ventilation group (relative risk, 0.48; 95% confidence interval [CI], 0.30 to 0.77). Operator-reported aspiration occurred during 2.5% of intubations in the bag-mask ventilation group and during 4.0% in the no-ventilation group (P = 0.41). The incidence of new opacity on chest radiography in the 48 hours after tracheal intubation was 16.4% and 14.8%, respectively (P = 0.73).
CONCLUSIONS


Among critically ill adults undergoing tracheal intubation, patients receiving bag-mask ventilation had higher oxygen saturations and a lower incidence of severe hypoxemia than those receiving no ventilation. (Funded by Vanderbilt Institute for Clinical and Translational Research and others; PreVent ClinicalTrials.gov number, NCT03026322.).",2019,"Among critically ill adults undergoing tracheal intubation, patients receiving bag-mask ventilation had higher oxygen saturations and a lower incidence of severe hypoxemia than those receiving no ventilation.","['critically ill adults', '401 patients enrolled', 'critically ill adults undergoing tracheal intubation, patients receiving', 'seven intensive care units in the United States, we randomly assigned adults undergoing', 'Critically Ill Adults']","['positive-pressure ventilation with a bag-mask device (bag-mask ventilation', 'bag-mask ventilation', 'tracheal intubation to receive either ventilation with a bag-mask device or no ventilation between induction and laryngoscopy', 'Bag-Mask Ventilation']","['median lowest oxygen saturation', 'severe hypoxemia', 'lowest oxygen saturation', 'incidence of new opacity on chest radiography', 'oxygen saturations', 'incidence of severe hypoxemia, defined as an oxygen saturation of less than 80']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1265876', 'cui_str': 'Abnormally opaque structure (morphologic abnormality)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",401.0,0.247851,"Among critically ill adults undergoing tracheal intubation, patients receiving bag-mask ventilation had higher oxygen saturations and a lower incidence of severe hypoxemia than those receiving no ventilation.","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Dischert', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Brown', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Aline N', 'Initials': 'AN', 'LastName': 'Zouk', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Brent E', 'Initials': 'BE', 'LastName': 'Heideman', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Lester', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Toporek', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'From the Division of Allergy, Pulmonary, and Critical Care Medicine (J.D.C., R.M.B., B.E.H., M.G.L., A.H.T., T.W.R., M.W.S.), and the Department of Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; the Section of Pulmonary, Critical Care, and Allergy and Immunology (D.R.J.), and the Section of Emergency Medicine (D.J.V.), Louisiana State University School of Medicine-New Orleans, and the Department of Pulmonary and Critical Care Medicine, Ochsner Health System (D.J.V., K.M.D.) - both in New Orleans; the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (D.W.R., A.N.Z., S.G.); and the Department of Anesthesiology and Pain Medicine (A.M.J.) and the Division of Pulmonary and Critical Care (I.B.), University of Washington School of Medicine, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1812405']
386,32070246,Neurodevelopmental Outcomes at 42 Months After Thyroxine Supplementation in Infants Below 28 Weeks' Gestation: A Randomized Controlled Trial.,"Background:  Infants below 28 weeks' gestation have low thyroid hormone plasma levels compared with more mature infants and this may contribute to their risk of developmental disability. We aimed at determining the effect of supplementation with levothyroxine (LT4) for extremely premature infants born below 28 weeks' gestations on neurodevelopmental outcomes at 42 months.  Methods:  An explanatory double-blind, randomized, placebo-controlled trial consecutively recruited 153 infants below 28 weeks' gestation from 5 neonatal units in the United Kingdom. Infants were either supplemented with LT4 started intravenously during the first 5 days after birth and then changed to oral LT4 when enteral feeds were fully established (8 μg/kg birthweight/day as a single daily dose) or given placebo until 32 weeks' corrected gestational age. Neurodevelopmental outcomes at 42 months (range 40-43) were evaluated in 59 of these infants (30 LT4-supplemented, 29 placebo) by using Bayley III Mental and Psychomotor Developmental Indices. Cognition outcomes was correlated with plasma free thyroxine (fT4) level at 36 weeks and diffusion tensor imaging (DTI) markers.  Results:  The LT4 supplemented group performed significantly better in motor, language, and cognitive function domains. The mean of the difference between each group (95% confidence intervals [CI],  p -value) was motor domain 6.96 ([0.55-13.38],  p  = 0.034); language domain 8.93 ([0.16-17.70],  p  = 0.041); and cognition domain 6.35 ([0.14-12.55],  p  = 0.045). Neurodevelopmental outcome at 42 months had some associations with the trial's primary outcome (subarachnoid space width and motor outcome,  p  = 0.03), plasma fT4 level at 36 weeks (fT4 and cognition outcome,  p  = 0.01), and DTI at 36 weeks with cognition outcomes ( p  > 0.05).  Conclusion:  Our data suggest that early supplementation with LT4 may improve long-term neurodevelopment in infants born below 28 weeks' gestation, but larger trials are warranted as the current reported improvements shown are not strong enough to warrant a change in practice.",2020,"language domain 8.93 (0.16-17.70, p=0.041); cognition domain 6.35 (0.14-12.55, p=0.045).","[""extremely premature infants born below 28 weeks' gestations on neurodevelopmental outcomes at 42 months"", ""153 infants below 28 weeks' gestation from five neonatal units in the United Kingdom"", ""infants below 28 weeks' gestation""]","['placebo', 'levothyroxine (LT4', 'thyroxine supplementation', 'LT4']","['subarachnoid space width and motor outcome, p=0.03), plasma free thyroxine level at 36 weeks (FT4 and cognition outcome, p=0.01) and Diffusion Tensor Imaging (DTI', 'Bayley III Mental and Psychomotor Developmental Indices', 'motor, language and cognitive function domains', 'plasma free thyroxine level', 'Neurodevelopmental outcome']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}]","[{'cui': 'C0038527', 'cui_str': 'Subarachnoid Space'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1269635', 'cui_str': 'Plasma free thyroxine level'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",153.0,0.456237,"language domain 8.93 (0.16-17.70, p=0.041); cognition domain 6.35 (0.14-12.55, p=0.045).","[{'ForeName': 'Sze May', 'Initials': 'SM', 'LastName': 'Ng', 'Affiliation': ""Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Turner', 'Affiliation': ""Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.""}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Weindling', 'Affiliation': ""Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.""}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0293']
387,32273122,Surface dissolution and transesterification of thermoset dimethacrylate polymer by dimethacrylate adhesive resin and organic catalyst-alcohol solution.,"OBJECTIVES


To evaluate transesterification based dissolution of dimethacrylate and epoxy polymers, the former containing ester groups. Polymer substrates were treated with an adhesive resin (Stick™ Resin) and an organic catalyst-alcohol solution (ethylene glycol and triazabicyclodecene). The surface was chemically and nanomechanically analyzed with Fourier Transform-Infrared (FTIR) spectroscopy, surface profile peak (R p ) and nanohardness and modulus of elasticity.
METHODS


A total of 100 specimens each of light-cured dimethacrylate polymer and heat-cured diepoxy polymer were prepared. 20 specimens were randomly selected and used as control group (0s). The remaining specimens were randomly divided into 40 each for treatment with an Stick™ resin and ethylene glycol+triazabicyclodecene. Within each group the 40 specimens were randomly subdivided into 20 each for treatment at 5min and 24h, with 10 specimens for FTIR and nanohardness and modulus of elasticity, and the other 10 for SEM and surface R p  analyses.
RESULTS


Dimethacrylate polymer showed a reduction in the nanohardness and modulus of elasticity, R p  values and SEM also showed significant topographical changes after being treated with either Stick™ resin or ethylene glycol+triazabicyclodecene, whereas epoxy resin substrate did not. FTIR analyses affirmed changes in the intensity of ester groups.
SIGNIFICANCE


Ester group containing dimethacrylate polymer showed a reduction in NMP within 5min of exposure to the treatment agents with softening by solution ethylene glycol+triazabicyclodecene associated to the reduction of ester groups in the polymer structure by transesterification. Epoxy polymer without ester groups was not affected by surface softening with treatment agents. Adhesive resin caused surface swelling.",2020,"RESULTS


Dimethacrylate polymer showed a reduction in the nanohardness and modulus of elasticity, R p  values and SEM also showed significant topographical changes after being treated with either Stick™ resin or ethylene glycol+triazabicyclodecene, whereas epoxy resin substrate did not.","['A total of 100 specimens each of light-cured dimethacrylate polymer and heat-cured diepoxy polymer', '20 specimens']","['Ester group containing dimethacrylate polymer', 'adhesive resin (Stick™ Resin) and an organic catalyst-alcohol solution (ethylene glycol and triazabicyclodecene', 'Stick™ resin and ethylene glycol+triazabicyclodecene']","['Fourier Transform-Infrared (FTIR) spectroscopy, surface profile peak (R p ) and nanohardness and modulus of elasticity', 'NMP', 'surface swelling', 'nanohardness and modulus of elasticity, R p  values and SEM']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0440254', 'cui_str': 'Dimethacrylate'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]","[{'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0440254', 'cui_str': 'Dimethacrylate'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0015083', 'cui_str': 'ethylene glycol'}, {'cui': 'C2351312', 'cui_str': 'triazabicyclodecene'}, {'cui': 'C0015075', 'cui_str': 'Ethylene'}]","[{'cui': 'C0282183', 'cui_str': 'Fourier Transform'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}, {'cui': 'C0044438', 'cui_str': '1-methyl-2-pyrrolidinone'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}]",20.0,0.0141781,"RESULTS


Dimethacrylate polymer showed a reduction in the nanohardness and modulus of elasticity, R p  values and SEM also showed significant topographical changes after being treated with either Stick™ resin or ethylene glycol+triazabicyclodecene, whereas epoxy resin substrate did not.","[{'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Basavarajappa', 'Affiliation': 'Dental Biomaterial Research Chair, Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia. Electronic address: sbasavarajappa@ksu.edu.sa.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Perea-Lowery', 'Affiliation': 'Institute of Dentistry, Department of Biomaterials Science, University of Turku, FI-20520 Turku, Finland.'}, {'ForeName': 'Abdullah Maghram', 'Initials': 'AM', 'LastName': 'Alshehri', 'Affiliation': 'Dental Biomaterial Research Chair, Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Abdul Aziz Abdullah', 'Initials': 'AAA', 'LastName': 'Al-Kheraif', 'Affiliation': 'Dental Biomaterial Research Chair, Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Jukka P', 'Initials': 'JP', 'LastName': 'Matinlinna', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Applied Oral Sciences & Community Dental Care, Dental Materials Science, Hong Kong SAR, PR China.'}, {'ForeName': 'Pekka K', 'Initials': 'PK', 'LastName': 'Vallittu', 'Affiliation': 'Professor and Chair of Biomaterials Science and Turku Clinical Biomaterials Centre - TCBC, Institute of Dentistry, University of Turku and City of Turku Welfare Division, Oral Health Care, FI-20520 Turku, Finland.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.03.005']
388,32273276,Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer.,"PURPOSE


Two studies in previously treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (GM-CSF-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated  Listeria monocytogenes -expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B).
PATIENTS AND METHODS


Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B. The primary objective was to compare overall survival (OS) between the arms. Additional objectives included assessment of progression-free survival, safety, tumor responses, CA19-9 responses, and immunologic correlates.
RESULTS


Ninety-three patients were treated (Arm A, 51; Arm B, 42). The median OS in Arms A and B were 5.9 [95% confidence interval (CI), 4.7-8.6] and 6.1 (95% CI, 3.5-7.0) months, respectively, with an HR of 0.86 (95% CI, 0.55-1.34). Objective responses were seen in 3 patients using immune-related response criteria (4%, 2/51, Arm A; 2%, 1/42, Arm B). The grade ≥3 related adverse event rate, whereas higher in Arm A (35.3% vs. 11.9%) was manageable. Changes in the microenvironment, including increase in CD8 +  T cells and a decrease in CD68 +  myeloid cells, were observed in long-term survivors in Arm A only.
CONCLUSIONS


Although the study did not meet its primary endpoint of improvement in OS of Arm A over Arm B, the OS was comparable with standard therapy. Objective responses and immunologic changes in the tumor microenvironment were evident.",2020,"Changes in the microenvironment, including increase in CD8 +  T cells and a decrease in CD68 +  myeloid cells, were observed in long-term survivors in Arm A only.
","['previously-treated metastatic pancreatic cancer', 'Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease', 'Patients with Pancreatic Cancer']","['Cyclophosphamide/GVAX Pancreas Followed by Listeria-mesothelin (CRS-207', 'GVAX pancreas vaccine (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207']","['adverse event rate', 'CD8 +  T cells', 'progression-free survival, safety, tumor responses, CA19-9 responses and immunologic correlates', 'overall survival (OS', 'Objective responses', 'CD68 +  myeloid cells', 'median OS']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023859', 'cui_str': 'Listeria'}, {'cui': 'C0380162', 'cui_str': 'mesothelin'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0030297', 'cui_str': 'Neoplasm of pancreas'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0596993', 'cui_str': 'Stem Cells, Myeloid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",93.0,0.0916246,"Changes in the microenvironment, including increase in CD8 +  T cells and a decrease in CD68 +  myeloid cells, were observed in long-term survivors in Arm A only.
","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsujikawa', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Crocenzi', 'Affiliation': 'Providence Portland Medical Center, Portland, Oregon.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Onners', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Nauroth', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Reiss', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Vonderheide', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Tempero', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Fisher', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Considine', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Danilova', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Brockstedt', 'Affiliation': 'Aduro Biotech Inc., Berkeley, California.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Coussens', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland. dle@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3978']
389,32271970,Tofacitinib in psoriatic arthritis patients: skin signs and symptoms and health-related quality of life from two randomized phase 3 studies.,"BACKGROUND


Psoriatic arthritis (PsA) is a chronic, systemic immune-mediated inflammatory musculoskeletal disease. The onset of dermatologic symptoms often precedes rheumatic manifestations. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA that has been shown to improve dermatologic symptoms in patients with PsA.
OBJECTIVES


To investigate the efficacy of tofacitinib in improving dermatologic endpoints in adult patients with active PsA.
METHODS


This analysis included data from two placebo-controlled, double-blind, phase 3 studies in patients with active PsA and an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) who were tumor necrosis factor inhibitor (TNFi)-naïve (OPAL Broaden; NCT01877668) or an IR to ≥1 TNFi (OPAL Beyond; NCT01882439). Patients had active plaque psoriasis at screening and received a stable dose of one csDMARD during the study. Patients were randomized to tofacitinib 5 mg twice daily (BID), 10 mg BID, adalimumab 40 mg subcutaneous injection once every 2 weeks (OPAL Broaden only) or placebo (to Month 3). Dermatologic endpoints: Psoriasis Area and Severity Index (PASI) total score; PASI90 overall; PASI75 and PASI90 by baseline PASI severity; Physician's Global Assessment of Psoriasis; Nail Psoriasis Severity Index; Dermatology Life Quality Index total and sub-dimension scores; Itch Severity Item; and Patient's Global Joint and Skin Assessment-Visual Analog Scale-Psoriasis question.
RESULTS


In patients with active PsA, including those stratified by mild or moderate/severe dermatologic symptoms, greater improvements from baseline and percentage of responders were observed in tofacitinib-treated patients vs. placebo for the majority of analyzed dermatologic endpoints at Months 1 and 3, and improvements were maintained to Month 12 in OPAL Broaden and Month 6 in OPAL Beyond. Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints.
CONCLUSIONS


Tofacitinib provides a treatment option for patients with active PsA, including the burdensome dermatologic symptoms of PsA.",2020,"Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints.
","['patients with active PsA, including the burdensome dermatologic symptoms of PsA', 'adult patients with active PsA.\nMETHODS', 'Patients had active plaque psoriasis at screening and received a stable dose of one csDMARD during the study', 'patients with active PsA and an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) who were tumor necrosis factor inhibitor', 'patients with PsA', 'psoriatic arthritis patients']","['tofacitinib', 'Tofacitinib', 'placebo', 'adalimumab 40\xa0mg subcutaneous injection once every 2 weeks (OPAL Broaden only) or placebo']","['severe dermatologic symptoms', ""Dermatologic endpoints: Psoriasis Area and Severity Index (PASI) total score; PASI90 overall; PASI75 and PASI90 by baseline PASI severity; Physician's Global Assessment of Psoriasis; Nail Psoriasis Severity Index; Dermatology Life Quality Index total and sub-dimension scores; Itch Severity Item; and the Psoriasis question from Patient's Global Joint and Skin Assessment-Visual Analog Scale"", 'dermatologic symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0558035', 'cui_str': 'Skin assessment'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.502344,"Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints.
","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K Papp Clinical Research Inc, Waterloo, ON, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Department of Medicine, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Servicio de Reumatología, Hospital Universitari Parc Taulí Sabadell, Barcelona, Spain.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Division of Dermatology and Venereology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'M-A', 'Initials': 'MA', 'LastName': 'Hsu', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16433']
390,31885071,Heterogenous treatment effects of transfusion thresholds by patient age: Post-hoc analysis of the TRISS trial.,"BACKGROUND


Use of a lower haemoglobin (Hb) threshold to guide red blood cell (RBC) transfusion is now generally recommended in critically ill patients, but uncertainty remains regarding the optimal Hb threshold for RBC transfusion in patients of different ages.
METHODS


We conducted a post-hoc analysis of 998 patients with septic shock and anaemia randomised to RBC transfusion at a Hb threshold of 7 g/dl [4.3 mmol/l] vs 9 g/dl [5.6 mmol/l] in the Transfusion Requirements in Septic Shock (TRISS) trial. We assessed if there were heterogeneous effects between the allocated Hb threshold and patient age categorised and on the continuous scale. The primary outcome was 1-year mortality; the secondary outcome was 90-day mortality. Both outcomes were analysed using logistic regression models and in sensitivity analyses with additional adjusting for site of enrolment, presence of haematological malignancy and the Sequential Organ Failure Assessment (SOFA) score. The secondary analyses were Kaplan-Meier curves with corresponding log-rank tests.
RESULTS


We found no heterogeneity between patient age and the allocated Hb thresholds for RBC transfusion for 1-year mortality or 90-day mortality in the primary analyses. The sensitivity analyses suggested heterogeneity between age groups regarding 90-day mortality, however, this was not consistent for 1-year mortality or when assessing age on the continuous scale.
CONCLUSION


In this post-hoc study of ICU patients with septic shock, we found no reliable heterogeneous effects of transfusion at a Hb threshold of 7 vs 9 g/dl according to patient age on mortality. However, due to low power, this study should only be considered as hypothesis generating.",2020,We found no heterogeneity between patient age and the allocated Hb-thresholds for RBC transfusion for 1-year mortality or 90-day mortality in the primary analyses.,"['ICU patients with septic shock', '998 patients with septic shock and anaemia randomised to', 'critically ill patients', 'patient age']",['RBC transfusion at a Hb-threshold of 7 g/dl [4.3 mmol/l] vs. 9 g/dl [5.6 mmol/l'],"['90-day mortality', 'haematological malignancy and the Sequential Organ Failure Assessment (SOFA) score', '1-year mortality', '1-year mortality or 90-day mortality']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",998.0,0.207121,We found no heterogeneity between patient age and the allocated Hb-thresholds for RBC transfusion for 1-year mortality or 90-day mortality in the primary analyses.,"[{'ForeName': 'Andreas Bender', 'Initials': 'AB', 'LastName': 'Jonsson', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Sofie Louise', 'Initials': 'SL', 'LastName': 'Rygård', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Broksø Holst', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13538']
391,32269170,"Correction:  Regular, sustained-release morphine for chronic breathlessness: a multicentre, double-blind, randomised, placebo-controlled trial .",,2020,,['chronic breathlessness'],"['placebo', 'Correction:  Regular, sustained-release morphine']",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.761976,,[],Thorax,['10.1136/thoraxjnl-2019-213681corr1']
392,32259266,Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.,"Importance


The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair.
Objective


To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
Design, Setting, and Participants


The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders.
Discussion


The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice.
Trial Registration


ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.",2020,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","['patients who underwent fracture repair', '1540 patients with open extremity fractures from at least 12 hospitals', 'patients with open extremity fractures and patients with closed lower extremity or pelvic fractures', 'patients with open extremity fractures', '1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals', 'Patients', 'Open Fractures', 'Fractured Extremities']","['Pre-Operative Aqueous Antiseptic Skin Solution', 'isopropyl alcohol', 'chlorhexidine', 'Fracture Repair', 'Iodophor vs Chlorhexidine Solutions', 'iodophor vs chlorhexidine solutions', 'isopropyl alcohol vs 0.7% iodine povacrylex', 'povidone-iodine']","['surgical site infection', 'unplanned fracture-related reoperations', 'surgical site infections and unplanned fracture-related reoperations', 'Surgical Site Infections and Unplanned Reoperations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0021988', 'cui_str': 'Iodophors'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C1876049', 'cui_str': 'iodine povacrylex'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",6280.0,0.141164,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'Trauma Survivors Network, Falls Church, Virginia.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Garibaldi', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Association of periOperative Registered Nurses, Denver, Colorado.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Petrisor', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Mullins', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pogorzelski', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Marvel', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Mossuto', 'Affiliation': 'Hamilton Health Science, Hamilton, Ontario, Canada.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Grissom', 'Affiliation': 'Trauma Survivor Network, Baltimore, Maryland.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Del Fabbro', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Della Rocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia.'}, {'ForeName': 'Haley K', 'Initials': 'HK', 'LastName': 'Demyanovich', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'I Leah', 'Initials': 'IL', 'LastName': 'Gitajn', 'Affiliation': 'Department of Orthopaedics, Dartmouth University, Hanover, New Hampshire.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': ""D'Alleyrand"", 'Affiliation': 'Department of Orthopaedic Surgery, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Friedrich', 'Affiliation': 'Washington, DC.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rivera', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rudnicki', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Fowler', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Jeray', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Marchand', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah, Salt Lake City.'}, {'ForeName': 'Lyndsay M', 'Initials': 'LM', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Manjari G', 'Initials': 'MG', 'LastName': 'Joshi', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Talbot', 'Affiliation': 'Canadian Armed Forces, Montreal, Qubec, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Camara', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Olivia Paige', 'Initials': 'OP', 'LastName': 'Szasz', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKay', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zura', 'Affiliation': 'Department of Orthopaedics, Louisiana State University Health, New Orleans.'}, {'ForeName': 'Saam', 'Initials': 'S', 'LastName': 'Morshed', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dodds', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Tanner', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Uyen', 'Initials': 'U', 'LastName': 'Nguyen', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2215']
393,32267330,Effects of added salt reduction on central and peripheral blood pressure.,"BACKGROUND


Although the effects of salt intake reduction on casual blood pressure have been extensively studied in hypertensive individuals, data on reductions of added salt on arterial stiffness in both normotensive and prehypertensive subjects are scarce.
OBJECTIVE


To evaluate the effects of progressive reduction in added salt intake (from 6 grams to 4 grams per day) on peripheral and central blood pressure and arterial stiffness in normotensive, prehypertensive and hypertensive individuals.
METHODS


This was a single-blinded clinical trial with 13 weeks of follow-up. Normotensive (≤ 130/85 mmHg), prehypertensive (≥ 130 e < 139/≥ 85 e < 90 mmHg) and stage 1 hypertensive individuals (< 139/≥ 85 and < 90 mmHg) were assessed. Casual blood pressure measurements and ambulatory blood pressure monitoring were performed using the automated OMRON 705CP device, and central blood pressure was measured using the Sphygmocor®. Twenty-four-hour urinary sodium excretion and the amounts of added salt consumed were measured. Statistically significance level was set at p < 0.05 for all analysis.
RESULTS


A total of 55 participants (18 normotensive, 15 prehypertensive and 22 hypertensive), median age 48 years (IQR:39-54) were studied. The groups were not different in age or sex. No difference was observed in blood pressure or sodium excretion levels before and after the intervention. No significant changes in arterial stiffness parameters were observed.
CONCLUSION


The progressive reduction in added salt intake during a period of 13 weeks did not cause significant reductions in peripheral and central blood pressure. (Arq Bras Cardiol. 2020; 114(3):554-561).",2020,The progressive reduction in added salt intake during a period of 13 weeks did not cause significant reductions in peripheral and central blood pressure.,"['normotensive, prehypertensive and hypertensive individuals', 'hypertensive individuals', '130 e < 139/≥ 85 e < 90 mmHg) and stage 1 hypertensive individuals (< 139/≥ 85 and < 90 mmHg', 'Normotensive (≤ 130/85 mmHg), prehypertensive (≥', '55 participants (18 normotensive, 15 prehypertensive and 22 hypertensive), median age 48 years (IQR:39-54) were studied']","['salt intake reduction', 'added salt reduction']","['central and peripheral blood pressure', 'arterial stiffness parameters', 'Casual blood pressure measurements and ambulatory blood pressure monitoring', 'central blood pressure', 'blood pressure or sodium excretion levels', 'peripheral and central blood pressure and arterial stiffness', 'peripheral and central blood pressure', 'casual blood pressure']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",55.0,0.0274451,The progressive reduction in added salt intake during a period of 13 weeks did not cause significant reductions in peripheral and central blood pressure.,"[{'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Arantes', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Ana Luiza Lima', 'Initials': 'ALL', 'LastName': 'Sousa', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Priscila Valverde de O', 'Initials': 'PVO', 'LastName': 'Vitorino', 'Affiliation': 'Pontificia Universidade Católica de Goiás - Escola de Ciências Sociais e da Saúde - Mestrado em Atenção à Saúde, Goiânia, Goiás - Brasil.'}, {'ForeName': 'Paulo Cesar B Veiga', 'Initials': 'PCBV', 'LastName': 'Jardim', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Thiago de Souza Veiga', 'Initials': 'TSV', 'LastName': 'Jardim', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Jeeziane Marcelino', 'Initials': 'JM', 'LastName': 'Rezende', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Ellen de Souza', 'Initials': 'ES', 'LastName': 'Lelis', 'Affiliation': 'Pontificia Universidade Católica de Goiás - Escola de Ciências Sociais e da Saúde - Mestrado em Atenção à Saúde, Goiânia, Goiás - Brasil.'}, {'ForeName': 'Rafaela Bernardes', 'Initials': 'RB', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Coca', 'Affiliation': 'Universitat de Barcelona, Barcelona - Espanha.'}, {'ForeName': 'Weimar Kunz Sebba', 'Initials': 'WKS', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180426']
394,30727012,Pericardial fluids or Cardiopulmonary Bypass-Is There a Major Culprit for Changes in Coagulation and Inflammation?,"BACKGROUND


From the results of a previous study, it remained to be investigated if a perioperative rise of few tested coagulation and inflammation markers is caused by conventional cardiopulmonary bypass (CPB) itself or rather by direct recirculation of pericardial fluids.
METHODS


Forty-eight patients operated on with conventional CPB for myocardial revascularization were randomized either for direct recirculation of pericardial suction fluids or for cell saving (CS).
RESULTS


Thrombin-antithrombin complexes showed lower values intraoperatively in the CS group ( p  < 0.0001), and D-dimers tended to remain lower at intensive care unit arrival ( p  = 0.095). Tests of inflammation markers were less meaningful.
CONCLUSION


Direct recirculation of pericardial fluids rather than conventional CPB itself causes major intraoperative changes of some coagulation markers. Pericardial blood loss with direct recirculation should be kept to a minimum to avoid unnecessary activation of coagulation. Inflammation markers need further investigations.",2020,"RESULTS


Thrombin-antithrombin complexes showed lower values intraoperatively in the CS group ( p  < 0.0001), and D-dimers tended to remain lower at intensive care unit arrival ( p  = 0.095).",['Forty-eight patients operated on with conventional CPB for myocardial revascularization'],"['Pericardial fluids or Cardiopulmonary Bypass', 'direct recirculation of pericardial suction fluids or for cell saving (CS', 'conventional CPB']",[],"[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0027056', 'cui_str': 'Myocardial Revascularization'}]","[{'cui': 'C0225973', 'cui_str': 'Pericardium Fluid'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0442031', 'cui_str': 'Pericardial (qualifier value)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]",[],48.0,0.028727,"RESULTS


Thrombin-antithrombin complexes showed lower values intraoperatively in the CS group ( p  < 0.0001), and D-dimers tended to remain lower at intensive care unit arrival ( p  = 0.095).","[{'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Gorki', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kunert', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hoenicka', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Liebold', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0039-1677836']
395,32274986,"Use, Acceptability, Performance, and Health Impact of Hollow Fiber Ultrafilters for Water Treatment in Rural Kenyan Households, 2009-2011.","Diarrheal illness remains a leading cause of morbidity and mortality in children < 5 years in developing countries, and contaminated water contributes to diarrhea risk. To address this problem, a novel hollow fiber ultrafilter (HFU) was developed for household water treatment. To test its impact on water quality and infant health, we conducted a cluster-randomized longitudinal evaluation in 10 intervention and 10 comparison villages in Kenya, attempting to enroll all households with infants (< 12 months old). We conducted a baseline survey, distributed HFUs to intervention households, made biweekly home visits for 1 year to assess water treatment practices and diarrhea in infants, and tested water samples from both groups every 2 months for  Escherichia coli . We enrolled 92 infants from intervention households and 74 from comparison households. During the 1-year study period, 45.7% of intervention households and 97.3% of comparison households had at least one stored water sample test positive for  E. coli . Compared with comparison households, the odds of  E. coli  contamination in stored water was lower for intervention households (odds ratio [OR]: 0.42, 95% CI: 0.24, 0.74), but there was no difference in the odds of reported diarrhea in infants, adjusting for covariates (OR: 1.19, 95% CI: 0.74, 1.90). Although nearly all water samples obtained from unprotected sources and filtered by the HFU were free of  E. coli  contamination, HFUs alone were not effective at reducing diarrhea in infants.",2020,"Compared with comparison households, the odds of  E. coli  contamination in stored water was lower for intervention households (OR: 0.42, 95% CI: 0.24, 0.74), but there was no difference in the odds of reported diarrhea in infants, adjusting for covariates (OR: 1.19, 95% CI: 0.74, 1.90).","['92 infants from intervention households and 74 from comparison households', 'children < 5 years in developing countries', '10 intervention and 10 comparison villages in Kenya, attempting to enroll all households with infants (< 12 months old', 'Rural Kenyan Households, 2009-2011']",[],"['Use, Acceptability, Performance, and Health Impact of Hollow Fiber Ultrafilters', 'diarrhea', 'water quality and infant health']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}]",[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332484', 'cui_str': 'Hollow shape'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}]",92.0,0.0801791,"Compared with comparison households, the odds of  E. coli  contamination in stored water was lower for intervention households (OR: 0.42, 95% CI: 0.24, 0.74), but there was no difference in the odds of reported diarrhea in infants, adjusting for covariates (OR: 1.19, 95% CI: 0.74, 1.90).","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fagerli', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gieraltowski', 'Affiliation': 'Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Nygren', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Foote', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gaines', 'Affiliation': 'Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Oremo', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Aloyce', 'Initials': 'A', 'LastName': 'Odhiambo', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Sunkyung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Quick', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0862']
396,32165347,Combined Heart-Kidney Transplant Versus Sequential Kidney Transplant in Heart Transplant Recipients.,"OBJECTIVES


In patients with reduced kidney function there are no established guidelines to suggest combined heart-kidney transplant (HKTx) versus sequential kidney transplant (SKTx) using preoperative value of estimated glomerular filtration (eGFR).
METHODS


The United Network for Organ Sharing database was queried from 2000 to 2015 to evaluate survival of HKTx and SKTx population stratified by preoperative eGFR rate <45 mL/min. Aim of the study was to assess the eGFR rate that is most beneficial to perform a concomitant or a SKTx at time of transplant evaluation.
RESULTS


In our analysis, patients who required SKTx are recipients that, after heart transplantation, developed or worsened kidney insufficiency due to calcineurin inhibitor nephrotoxicity. In recipients with eGFR <30 or dialysis, a total of 545 received HKTx and 80 received SKTx. The median waiting time between heart and kidney transplant in SKTx group was 6 years. The overall post-transplant survival was 81% and 80% and 75% and 59% at 5 and 1 years for the HKTx and SKTx groups, respectively (P = .04). In recipients with eGFR from 30 to 44, a total of 107 received HKTx and 112 received SKTx. The median waiting time between heart and kidney transplant in SKTx group was 4 years. Overall post-transplant survival showed no statistically significant differences in HKTx group (n=107) compared with SKTx group (n=112) and was 90% and 95% at 1 year and 74% and 52% at 5 years, respectively (P = .4) .
CONCLUSIONS


To optimize organ and patient survival, eGFR value can be utilized to discern between HKTx versus SKTx in patients with decreased renal function at the time of heart transplantation. Patients with eGFR<30 or in dialysis presented better survival with HKTx, while both SKTx and HKTx are suitable for patients with eGFR between 30 and 45.",2020,"Overall post transplant survival showed no statistically significant differences in HKTx group (n=107) compared to SKTx group (n=112) and was 90% and 95% at 1 year and 74% and 52% at 5 years, respectively (p=0.4) .
","['Heart Transplant Recipients', 'The United Network for Organ Sharing database was queried from 2000 to 2015 to evaluate survival of HKTx and SKTX population stratified by preoperative eGFR rate < 45ml/min', 'recipients with eGFR <30 or dialysis, a total of 545 received HKTx and 80 received', 'recipients with eGFR from 30 to 44, a total of 107 received HKTx and 112 received']","['SKTx', 'Combined Heart-Kidney Transplant versus Sequential Kidney Transplant']","['overall post transplant survival', 'median waiting time', 'renal function', 'eGFR rate', 'Overall post transplant survival']","[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.0316457,"Overall post transplant survival showed no statistically significant differences in HKTx group (n=107) compared to SKTx group (n=112) and was 90% and 95% at 1 year and 74% and 52% at 5 years, respectively (p=0.4) .
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Gallo', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Jaimin R', 'Initials': 'JR', 'LastName': 'Trivedi', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Schumer', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Slaughter', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky. Electronic address: mark.slaughter@louisville.edu.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.03.002']
397,31950482,Effects of anaesthesia-induced hypotension and phenylephrine on plasma volume expansion by hydroxyethyl starch: A randomised controlled study.,"BACKGROUND


Changes in blood haemoglobin concentration indicate plasma volume expansion following hydroxyethyl starch (HES) infusion, but may be affected by vascular tone and HES-induced shedding of the endothelial surface layer (ESL). We hypothesised that anaesthesia-induced hypotension enhances changes in plasma volume as assessed by blood haemoglobin concentration (ΔPV Hb  , %) following HES infusion.
METHODS


Fifty-two patients undergoing abdominal surgery were randomised to receive a continuous infusion of saline (S group) or phenylephrine to restore vascular tone (P group) (n = 26 each). Both groups received an infusion of 8 mL/kg 6% HES solution after induction of general anaesthesia. We compared ΔPV Hb  at the end of fluid infusion (15 minutes) and 15 minutes later (30 minutes) between the two groups. We assessed changes in ESL structure by measuring plasma concentrations of hyaluronate and syndecan-1. P < .05 was considered statistically significant.
RESULTS


Mean arterial blood pressure was lower in the S group approximately by 30-40% compared to the P group (P < .001). ΔPV Hb  was larger in the S group compared to the P group at 15 minutes (24.9 [5.2] % vs 19.0 [5.2] %; P < .001) and 30 minutes (26.5 [5.9] % vs 16.9 [6.6] %; P < .001). There were no clinically significant differences in plasma concentrations of hyaluronate and syndecan-1 with time and between the groups.
CONCLUSIONS


Increased volume expansion of circulating plasma following HES infusion in anaesthesia-induced hypotension compared to when blood pressure is restored by phenylephrine may result from an attenuation of transcapillary fluid filtration, rather than ESL shedding. UMIN Clinical Trial Registration Number: UMIN000017394 (http://www.umin.ac.jp/ctr/index.htm).",2020,"There were noclinicallysignificant differences in plasma concentrations of hyaluronate and syndecan-1with time and betweenthe groups.
",['Fifty-two patients undergoing abdominal surgery'],"['hydroxyethyl starch', 'continuous infusion of saline (S group) or phenylephrine to restorevascular tone(P group', 'anaesthesia-induced hypotension and phenylephrine', 'infusion of 8 ml/kg 6% HES solution', 'hydroxyethyl starch (HES']","['plasma concentrations of hyaluronate and syndecan-1with time', 'blood haemoglobin concentration', 'Mean arterial blood pressure', 'plasma volume expansion', 'ΔPV Hb']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}, {'cui': 'C0075691'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005768'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}]",52.0,0.44973,"There were noclinicallysignificant differences in plasma concentrations of hyaluronate and syndecan-1with time and betweenthe groups.
","[{'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Tatara', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Munetaka', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Hyogo, Japan.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13548']
398,31950485,Oxycodone for pain management in the latent phase of labour - A pragmatic trial.,"BACKGROUND


Parenteral opioids are used for pain relief in labour but there are little data for oxycodone in this context. The aim of this study was to evaluate the efficacy, foetal exposure and safety of subcutaneous oxycodone in the latent phase of labour.
METHODS


This pragmatic trial included 76 parturients, who received subcutaneous oxycodone for pain relief in the latent phase of labour according to the hospital protocol: an initial dose 0.1 mg/kg, and a second dose, 0.05 mg/kg, could be administered four hours later. Pain intensity and pain relief were assessed using a numerical rating scale of 0-10. After delivery, blood samples from the maternal and umbilical veins were collected, and plasma concentrations of oxycodone and its main metabolites were quantified using UPLC-MS/MS. The Apgar scores and maternal and neonatal adverse effects were recorded.
RESULTS


The foetal exposure at birth was low, the median oxycodone and oxymorphone umbilical vein plasma concentrations were 1.2 ng/mL (range 0.21-7.8) and 0.14 ng/mL (0-0.26), respectively. Pain scores decreased substantially, from a median pain score of 7/10 before oxycodone to median scores of 5/10 at 30 minutes after administration, 5/10 at 60 minutes and 6/10 at 120 minutes. The median Apgar score was 9 (range 2-10) at 1 minute and 9 (6-10) at 5 minutes. Maternal adverse effects were mild, and there were no oxycodone-related neonatal adverse effects.
CONCLUSION


Subcutaneous oxycodone provided effective analgesia during the latent phase of labour. Newborn exposure at birth was low, and oxycodone was well-tolerated.",2020,"Maternal adverse effects were mild, and there were no oxycodone-related neonatal adverse effects.
",[],"['Oxycodone', 'Subcutaneous oxycodone', 'subcutaneous oxycodone']","['effective analgesia', 'median pain score', 'efficacy, foetal exposure and safety', 'Apgar scores and maternal and neonatal adverse effects', 'plasma concentrations of oxycodone and its main metabolites', 'Pain scores', 'Maternal adverse effects', 'median Apgar score', 'Pain intensity and pain relief', 'median oxycodone and oxymorphone umbilical vein plasma concentrations', 'pain relief']",[],"[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0549411', 'cui_str': 'Neonatal adverse effect'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030073', 'cui_str': 'Oxymorphone'}, {'cui': 'C0221313', 'cui_str': 'Fetal umbilical vein structure'}]",,0.285624,"Maternal adverse effects were mild, and there were no oxycodone-related neonatal adverse effects.
","[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Kinnunen', 'Affiliation': 'School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kokki', 'Affiliation': 'School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hautajärvi', 'Affiliation': 'Admescope Ltd, Oulu, Finland.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Tuovinen', 'Affiliation': 'School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Kokki', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kuopio University Hospital, Kuopio, Finland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13550']
399,32101302,Effect of a Skin Self-monitoring Smartphone Application on Time to Physician Consultation Among Patients With Possible Melanoma: A Phase 2 Randomized Clinical Trial.,"Importance


Melanoma is among the most lethal skin cancers; it has become the fifth most common cancer in the United Kingdom, and incidence rates are rising. Population approaches to reducing incidence have focused on mass media campaigns to promote earlier presentation and potentially improve melanoma outcomes; however, interventions using smartphone applications targeting those with the greatest risk could promote earlier presentation to health care professionals for individuals with new or changing skin lesions.
Objective


To study the effect of a commercially available skin self-monitoring (SSM) smartphone application among individuals with increased risk of melanoma on their decision to seek help for changing skin lesions.
Design, Setting, and Participants


This phase 2 randomized clinical trial was conducted in 12 family practices in Eastern England between 2016 and 2017. A total of 238 participants, aged 18 to 75 years and with an increased risk of melanoma, were identified using a real-time melanoma risk assessment tool in family practice waiting rooms. Analysis was intention to treat. Participants were observed for 12 months, and data analysis was conducted from January to August 2018.
Intervention


The intervention and control groups received a consultation with standard written advice on sun protection and skin cancer detection. The intervention group had an SSM application loaded on their smartphone and received instructions for use and monthly self-monitoring reminders.
Main Outcomes and Measures


The coprimary outcomes were skin consultation rates with family practice physicians and patient intervals, measured as the time between noticing a skin change and consulting with a family practice clinician. Follow-up questionnaires were sent at 6 and 12 months, and consultation rates were extracted from family practice records. Secondary outcomes included skin self-examination benefits and barriers, self-efficacy for consulting without delay, perceived melanoma risk, sun protection habits, and potential harms.
Results


A total of 238 patients were randomized (median [interquartile range] age, 55 [43-65] years, 131 [55.0%] women, 227 [95.4%] white British; 119 [50.0%] randomized to the intervention group). Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire. There were no significant differences in skin consultation rates (adjusted risk ratio, 0.96; 95% CI, 0.56 to 1.66; P = .89), measures of SSM (adjusted mean difference, 0.08; 95% CI, -0.83 to 1.00; P = .86), or psychological harm (eg, Melanoma Worry Scale: adjusted mean difference, -0.12; 95% CI, -0.56 to 0.31; P = .58).
Conclusions and Relevance


In this study, recruitment, retention, and initial delivery of the intervention were feasible, and this research provided no evidence of harm from the SSM smartphone application. However, no evidence of benefit on skin self-examination or health care consulting was found, and there is no reason at this stage to recommend its implementation in this population at increased risk of melanoma.
Trial Registration


isrctn.org Identifier: ISRCTN16061621.",2020,"Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire.","['238 participants, aged 18 to 75 years and with an increased risk of melanoma, were identified using a real-time melanoma risk assessment tool in family practice waiting rooms', 'Patients With Possible Melanoma', 'individuals with new or changing skin lesions', 'individuals with increased risk of melanoma', '238 patients were randomized (median [interquartile range] age, 55 [43-65] years, 131 [55.0%] women, 227 [95.4%] white British; 119 [50.0', '12 family practices in Eastern England between 2016 and 2017']","['Skin Self-monitoring Smartphone Application', 'consultation with standard written advice on sun protection and skin cancer detection', 'SSM application loaded on their smartphone and received instructions for use and monthly self-monitoring reminders', 'commercially available skin self-monitoring (SSM) smartphone application']","['skin consultation rates with family practice physicians and patient intervals, measured as the time between noticing a skin change and consulting with a family practice clinician', 'skin consultation rates', 'consultations regarding skin changes', 'Time to Physician Consultation', 'skin self-examination benefits and barriers, self-efficacy for consulting without delay, perceived melanoma risk, sun protection habits, and potential harms', 'measures of SSM']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1278523', 'cui_str': 'White British'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",238.0,0.143568,"Overall, 51 participants (21.4%) had consultations regarding skin changes during the 12 months of follow-up, and 157 participants (66.0%) responded to at least 1 follow-up questionnaire.","[{'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Walter', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'Pannebakker', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Barclay', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Saunders', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murchie', 'Affiliation': 'Institute of Applied Health Science, Centre of Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Burrows', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Emery', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0001']
400,31889306,The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery.,"BACKGROUND


Perioperative blood loss is a major contributor to morbidity and mortality in cardiac surgery. Plasma fibrinogen levels play an essential role in hemostasis and deplete quickly during hemorrhage. The objective of this study was to determine whether prophylactic fibrinogen concentrate administration lowers overall blood product transfusion requirements in high-risk cardiac surgery in patients with low fibrinogen plasma levels.
METHODS


The study was performed in a prospective, randomized, and double-blinded design. The investigation included 62 patients undergoing elective, high-risk cardiac surgery. After weaning from cardiopulmonary bypass and reversal of heparin patients received either fibrinogen concentrate or placebo. The primary outcome variable was overall blood product usage 24 hours after intervention.
RESULTS


The fibrinogen group received numerically fewer total units of blood products than the placebo group, but the difference was not statistically or clinically significant (for groups n = 27; n = 29 and 19 vs 37 units, respectively, P = .908). The overall transfusion rate in both groups was significantly lower than the institutional average suggested (fibrinogen group 26%, placebo group 28%). The fibrinogen group showed significantly higher fibrinogen levels (2.38 vs 1.83 g/L (end of surgery), P < .001; 3.33 vs 2.68 g/L (12 hours after intervention), P = .003) and improved viscoelastic coagulation parameters (FIBTEM MCF, 27 vs 23 mm, P = .022).
CONCLUSION


This randomized, controlled trial demonstrates that point-of-care guided and prophylactic treatment with fibrinogen concentrate does not reduce transfusion of blood products in a setting of unexpectedly low transfusion rate as tested in this cohort, but may improve coagulation parameters in the setting of high-risk cardiac surgery.",2020,"The fibrinogen group received numerically fewer total units of blood products than the placebo group, but the difference was not statistically or clinically significant (for groups n=27; n=29 and 19 vs 37 units respectively, p=0.908).","['high-risk cardiac surgery in patients with low fibrinogen plasma levels', 'high-risk cardiac surgery', '62 patients undergoing elective, high-risk cardiac surgery', 'cardiac surgery']","['fibrinogen concentrate', 'fibrinogen concentrate or placebo', 'placebo', 'heparin']","['viscoelastic coagulation parameters', 'total units of blood products', 'fibrinogen levels', 'overall transfusion rate', 'overall blood product usage 24 h after intervention']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439184', 'cui_str': 'Units of blood (qualifier value)'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",62.0,0.671292,"The fibrinogen group received numerically fewer total units of blood products than the placebo group, but the difference was not statistically or clinically significant (for groups n=27; n=29 and 19 vs 37 units respectively, p=0.908).","[{'ForeName': 'Myron M', 'Initials': 'MM', 'LastName': 'Kwapisz', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Blaine', 'Initials': 'B', 'LastName': 'Kent', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'DiQuinzio', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'LeGare', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, New Brunswick Heart Centre, Saint John, NB, Canada.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Garnett', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Willi', 'Initials': 'W', 'LastName': 'Swyer', 'Affiliation': 'Department of Surgery, Perfusion Services, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Whynot', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Mingo', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Scheffler', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13540']
401,31950481,"Efficacy and safety of iloprost in patients with septic shock-induced endotheliopathy-Protocol for the multicenter randomized, placebo-controlled, blinded, investigator-initiated trial.","BACKGROUND


In Europe 700.000 new cases of sepsis occur annually and more than 100.000 of these patients die due to multiorgan failure (MOF). We have identified shock-induced endotheliopathy (SHINE) to be associated with development of MOF and mortality. Furthermore, in patients with septic shock those with circulating levels of thrombomodulin (TM) above 10 ng/mL have twice the mortality (56% vs 28%) than those with levels below this level. Pilot studies indicate that infusion of iloprost (1 ng/kg/min) is associated with improved endothelial function in patients with septic shock.
MATERIAL AND METHODS


This is a multicenter, randomized, blinded, investigator-initiated, adaptive phase 2B trial in up to 384 patients with septic shock-induced endotheliopathy defined by TM > 10 ng/mL who are allocated 1:1 to 72 hours continuous infusion of iloprost 1 ng/kg/min or placebo (equal volume of saline). The primary outcome is the mean daily modified Sequential Organ Failure Assessment (SOFA) score in the ICU up to day 90. Secondary outcomes include 28- and 90-day all-cause mortality, days alive without vasopressor in the ICU within 90 days, days alive without mechanical ventilation in the ICU within 90 days, days alive without renal replacement therapy in the ICU within 90 days, numbers of serious adverse reactions, and the number of serious adverse events within the first 7 days.
DISCUSSION


This trial tests the safety and efficacy of iloprost vs placebo for 72 hours in patients with septic shock and SHINE. The outcome measures focus on the potential effect of the intervention to mitigate organ failure.
TRIAL REGISTRATION


COMBAT-SHINE trial-EudraCT no. 2019-001131-31-Clinicaltrials.gov: NCT04123444-Ethics Committee no. H-19018258.",2020,"Pilot studies indicate that infusion of iloprost (1 ng/kg/min) is associated with improved endothelial function in patients with septic shock.
","['384 patients with septic shock-induced endotheliopathy defined by TM', 'patients with septic shock and SHINE', 'patients with septic shock-induced endotheliopathy - protocol', 'patients with septic shock']","['placebo', 'iloprost vs. placebo', 'iloprost 1ng/kg/min or placebo', 'iloprost']","['safety and efficacy', 'mortality', 'mean daily modified Sequential Organ Failure Assessment (SOFA) score', 'Efficacy and safety', 'numbers of serious adverse reactions and the number of serious adverse events', 'mitigate organ failure', 'endothelial function', '28- and 90-day all-cause mortality, days alive without vasopressor in the ICU within 90 days, days alive without mechanical ventilation in the ICU within 90 days, days alive without renal replacement therapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079594', 'cui_str': 'Iloprost'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",384.0,0.585395,"Pilot studies indicate that infusion of iloprost (1 ng/kg/min) is associated with improved endothelial function in patients with septic shock.
","[{'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Clausen', 'Affiliation': 'Department of Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Søe-Jensen', 'Affiliation': 'Department of Intensive Care, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Klaus T', 'Initials': 'KT', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Intensive Care, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pär I', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stensballe', 'Affiliation': 'Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13546']
402,30920646,Willingness to bear adversity and beliefs about the curability of advanced cancer in older adults.,"BACKGROUND


Older patients with advanced cancer who are 100% certain they will be cured pose unique challenges for clinical decision making, but to the authors' knowledge, the prevalence and correlates of absolute certainty about curability (ACC) are unknown.
METHODS


Cross-sectional data were collected in a geriatric assessment trial. ACC was assessed by asking patients, ""What do you believe are the chances that your cancer will go away and never come back with treatment?"" Response options were 100% (coded as ACC), >50%, 50/50, <50%, 0%, and uncertain. The willingness to bear adversity in exchange for longevity was assessed by asking patients to consider trade-offs between survival and 2 clinical outcomes that varied in abstractness: 1) maintaining quality of life (QOL; an abstract outcome); and 2) specific treatment-related toxicities (eg, nausea/vomiting, worsening memory). Logistic regression was used to assess the independent associations between willingness to bear adversity and ACC.
RESULTS


Of the 524 patients aged 70 to 96 years, approximately 5.3% reported that there was a 100% chance that their cancer would be cured (ACC). ACC was not found to be significantly associated with willingness to bear treatment-related toxicities, but was more common among patients who were willing to trade QOL for survival (adjusted odds ratio, 4.08; 95% CI, 1.17-14.26).
CONCLUSIONS


Patients who were more willing to bear adversity in the form of an abstract state, namely decreased QOL, were more likely to demonstrate ACC. Although conversations regarding prognosis should be conducted with all patients, those who are willing to trade QOL for survival may especially benefit from conversations that focus on values and emotions.",2019,"ACC was not found to be significantly associated with willingness to bear treatment-related toxicities, but was more common among patients who were willing to trade QOL for survival (adjusted odds ratio, 4.08; 95% CI, 1.17-14.26).
","['Older patients with advanced cancer', '524 patients aged 70 to 96\xa0years', 'older adults']",[],"['toxicities', 'quality of life (QOL; an abstract outcome); and 2) specific treatment-related toxicities (eg, nausea/vomiting, worsening memory']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",524.0,0.0394769,"ACC was not found to be significantly associated with willingness to bear treatment-related toxicities, but was more common among patients who were willing to trade QOL for survival (adjusted odds ratio, 4.08; 95% CI, 1.17-14.26).
","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wells', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Nikesha', 'Initials': 'N', 'LastName': 'Gilmore', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Babu', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Mary I', 'Initials': 'MI', 'LastName': 'Whitehead', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dale', 'Affiliation': 'Department of Supportive Care Medicine, City of Hope Comprehensive Cancer Center, Duarte, California.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Hurria', 'Affiliation': 'Department of Supportive Care Medicine, City of Hope Comprehensive Cancer Center, Duarte, California.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Family Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Pacific Cancer Research Consortium National Cancer Institute Community Oncology Research Program (NCORP), Seattle, Washington.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Southeast Clinical Oncology Research Consortium (SCOR), Winston-Salem, North Carolina.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Berenberg', 'Affiliation': 'Hawaii Minority Underserved National Cancer Institute Community Oncology Research Program (MU-NCORP), Honolulu, Hawaii.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}]",Cancer,['10.1002/cncr.32074']
403,31558624,"Regular, sustained-release morphine for chronic breathlessness: a multicentre, double-blind, randomised, placebo-controlled trial.","INTRODUCTION


Morphine may decrease the intensity of chronic breathlessness but data from a large randomised controlled trial (RCT) are lacking. This first, large, parallel-group trial aimed to test the efficacy and safety of regular, low-dose, sustained-release (SR) morphine compared with placebo for chronic breathlessness.
METHODS


Multisite (14 inpatient and outpatient cardiorespiratory and palliative care services in Australia), parallel-arm, double-blind RCT. Adults with chronic breathlessness (modified Medical Research Council≥2) were randomised to 20 mg daily oral SR morphine and laxative (intervention) or placebo and placebo laxative (control) for 7 days. Both groups could take ≤6 doses of 2.5 mg, ' as needed ', immediate-release morphine (≤15 mg/24 hours) as required by the ethics review board. The primary endpoint was change from baseline in intensity of  breathlessness now  (0-100 mm visual analogue scale; two times per day diary) between groups. Secondary endpoints included:  worst ,  best  and  average breathlessness ; unpleasantness of  breathlessness now , fatigue; quality of life; function; and harms.
RESULTS


Analysed by intention-to-treat, 284 participants were randomised to morphine (n=145) or placebo (n=139). There was no difference between arms for the primary endpoint (mean difference -0.15 mm (95% CI -4.59 to 4.29; p=0.95)), nor secondary endpoints. The placebo group used more doses of oral morphine solution during the treatment period (mean 8.7 vs 5.8 doses; p=0.001). The morphine group had more constipation and nausea/vomiting. There were no cases of respiratory depression nor obtundation.
CONCLUSION


No differences were observed between arms for breathlessness, but the intervention arm used less rescue immediate-release morphine.
TRIAL REGISTRATION NUMBER


ACTRN12609000806268.",2020,"There was no difference between arms for the primary endpoint (mean difference -0.15 mm (95% CI -4.59 to 4.29; p=0.95)), nor secondary endpoints.","['284 participants were randomised to', 'Multisite (14 inpatient and outpatient cardiorespiratory and palliative care services in Australia', 'chronic breathlessness', 'Adults with chronic breathlessness (modified Medical Research Council≥2']","['morphine', 'Regular, sustained-release morphine', '20\u2009mg daily oral SR morphine and laxative (intervention) or placebo and placebo laxative (control', 'placebo', 'Morphine', 'regular, low-dose, sustained-release (SR) morphine', 'oral morphine solution']","['constipation and nausea/vomiting', 'intensity of chronic breathlessness', '  worst ,  best  and  average breathlessness ; unpleasantness of  breathlessness now , fatigue; quality of life; function; and harms', 'intensity of  breathlessness now  (0-100\u2009mm visual analogue scale', 'rescue immediate-release morphine', 'respiratory depression nor obtundation']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0085628', 'cui_str': 'Stupor'}]",284.0,0.805557,"There was no difference between arms for the primary endpoint (mean difference -0.15 mm (95% CI -4.59 to 4.29; p=0.95)), nor secondary endpoints.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia david.currow@uts.edu.au.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Louw', 'Affiliation': 'McCloud Consulting Group, Sydney, New South Wales, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCloud', 'Affiliation': 'McCloud Consulting Group, Sydney, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Plummer', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'Northern Sydney Local Health District, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'McCaffrey', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Magnus Pär', 'Initials': 'MP', 'LastName': 'Ekström', 'Affiliation': 'IMPACCT, Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213681']
404,31738483,A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke.,"BACKGROUND


The use of intensive lipid-lowering therapy by means of statin medications is recommended after transient ischemic attack (TIA) and ischemic stroke of atherosclerotic origin. The target level for low-density lipoprotein (LDL) cholesterol to reduce cardiovascular events after stroke has not been well studied.
METHODS


In this parallel-group trial conducted in France and South Korea, we randomly assigned patients with ischemic stroke in the previous 3 months or a TIA within the previous 15 days to a target LDL cholesterol level of less than 70 mg per deciliter (1.8 mmol per liter) (lower-target group) or to a target range of 90 mg to 110 mg per deciliter (2.3 to 2.8 mmol per liter) (higher-target group). All the patients had evidence of cerebrovascular or coronary-artery atherosclerosis and received a statin, ezetimibe, or both. The composite primary end point of major cardiovascular events included ischemic stroke, myocardial infarction, new symptoms leading to urgent coronary or carotid revascularization, or death from cardiovascular causes.
RESULTS


A total of 2860 patients were enrolled and followed for a median of 3.5 years; 1430 were assigned to each LDL cholesterol target group. The mean LDL cholesterol level at baseline was 135 mg per deciliter (3.5 mmol per liter), and the mean achieved LDL cholesterol level was 65 mg per deciliter (1.7 mmol per liter) in the lower-target group and 96 mg per deciliter (2.5 mmol per liter) in the higher-target group. The trial was stopped for administrative reasons after 277 of an anticipated 385 end-point events had occurred. The composite primary end point occurred in 121 patients (8.5%) in the lower-target group and in 156 (10.9%) in the higher-target group (adjusted hazard ratio, 0.78; 95% confidence interval, 0.61 to 0.98; P = 0.04). The incidence of intracranial hemorrhage and newly diagnosed diabetes did not differ significantly between the two groups.
CONCLUSIONS


After an ischemic stroke or TIA with evidence of atherosclerosis, patients who had a target LDL cholesterol level of less than 70 mg per deciliter had a lower risk of subsequent cardiovascular events than those who had a target range of 90 mg to 110 mg per deciliter. (Funded by the French Ministry of Health and others; Treat Stroke to Target ClinicalTrials.gov number, NCT01252875.).",2020,"The incidence of intracranial hemorrhage and newly diagnosed diabetes did not differ significantly between the two groups.
","['patients had evidence of cerebrovascular or coronary-artery atherosclerosis and received a', '2860 patients were enrolled and followed for a median of 3.5 years; 1430']","['intensive lipid-lowering therapy', 'statin, ezetimibe', 'LDL cholesterol target group']","['LDL cholesterol level', 'lower risk of subsequent cardiovascular events', 'ischemic stroke, myocardial infarction, new symptoms leading to urgent coronary or carotid revascularization, or death from cardiovascular causes', 'incidence of intracranial hemorrhage and newly diagnosed diabetes', 'mean LDL cholesterol level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010054', 'cui_str': 'Coronary Atherosclerosis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C3495793', 'cui_str': 'Carotid revascularisation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C1320655', 'cui_str': 'Newly diagnosed diabetes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",2860.0,0.33835,"The incidence of intracranial hemorrhage and newly diagnosed diabetes did not differ significantly between the two groups.
","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Charles', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Abtan', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Béjot', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Cabrejo', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Giroud', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Guidoux', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hobeanu', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Philippa C', 'Initials': 'PC', 'LastName': 'Lavallée', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Byung-Chul', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Kyung-Bok', 'Initials': 'KB', 'LastName': 'Lee', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Leys', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mahagne', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Meseguer', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pico', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Samson', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sibon', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Sang-Min', 'Initials': 'SM', 'LastName': 'Sung', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Touboul', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Touzé', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Varenne', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Vicaut', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Nessima', 'Initials': 'N', 'LastName': 'Yelles', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': ""From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique-Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire-Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences Cerebrovasculaires (Y.S.), Centre de Pharmacoépidémiologie de l'APHP (N.Y.), and the Department of Endocrinology (E.B.), Hôpital de la Pitié-Salpêtrière, the Department of Biostatistics, APHP, Université Paris Diderot, Sorbonne Paris Cité, Fernand Widal Hospital (É.V.), and the Department of Endocrinology, Sorbonne University (E.B.), Paris, Équipe d'Accueil EA2694, Santé Publique: Epidémiologie et Qualité des Soins (J.L.), and the Department of Neurology, Stroke Unit, University of Lille, Centre Hospitalier Universitaire (CHU) de Lille (D.L.), Lille, the Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon (Y.B., M.G.), the Stroke Unit, Pasteur Hospital, Nice (M.-H.M.), Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, Lyon (N.N.), the Department of Neurology, Versailles University Hospital, Versailles (F.P.), the Department of Vascular Neurology, Pellegrin Tripode Hospital, University of Bordeaux, Bordeaux (I.S.), and the Department of Neurology, Université Caen Normandie, CHU Caen Normandie, INSERM Unité 1237, Cyceron, Caen (E.T.) - all in France; Asan Medical Center (J.S.K.), the Department of Neurology, Eunpyeong St. Mary's Hospital, Catholic University of Korea (Y.-J.K.), and the Department of Neurology, Soonchunhyang University College of Medicine (K.-B.L.), Seoul, Dong-a University Hospital (J.-K.C.) and the Department of Neurology and Stroke Center, Pusan National University Hospital (S.M.S.), Busan, and the Department of Neurology, Hallym University Sacred Heart Hospital, Anyang (B.-C.L.) - all in South Korea; and the National Heart and Lung Institute-Imperial College and the Institute of Cardiovascular Medicine and Science-Royal Brompton Hospital, London (P.G.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1910355']
405,31541606,Reducing Hypertension in a Poststroke Black and Hispanic Home Care Population: Results of a Pragmatic Randomized Controlled Trial.,"BACKGROUND


Uncontrolled hypertension (HTN) is a leading modifiable stroke risk factor contributing to global stroke disparities. This study is unique in testing a transitional care model aimed at controlling HTN in black and Hispanic poststroke, home health patients, an understudied group.
METHODS


A 3-arm randomized controlled trial design compared (i) usual home care (UHC), with (ii) UHC plus a 30-day nurse practitioner transitional care program, or (iii) UHC plus nurse practitioner plus a 60-day health coach program. The trial enrolled 495 black and Hispanic, English- and Spanish- speaking adults with uncontrolled systolic blood pressure (SBP ≥ 140 mm Hg) who had experienced a first-time or recurrent stroke or transient ischemic attack. The primary outcome was change in SBP from baseline to 3 and 12 months.
RESULTS


Mean participant age was 67; 57.0% were female; 69.7% were black, non-Hispanic; and 30.3% were Hispanic. Three-month follow-up retention was 87%; 12-month retention was 81%. SBP declined 9-10 mm Hg from baseline to 12 months across all groups; the greatest decrease occurred between baseline and 3 months. The interventions demonstrated no relative advantage compared to UHC.
CONCLUSION


The significant across-the-board SBP decreases suggest that UHC nurse/patient/physician interactions were the central component of SBP reduction and that additional efforts to lower recurrent stroke risk should test incremental improvements in usual care, not resource-intensive transitional care interventions. They also suggest the potential value of pragmatic home care programs as part of a broader strategy to overcome HTN treatment barriers and improve secondary stroke prevention globally.
CLINICAL TRIALS REGISTRATION


Trial Number NCT01918891.",2020,"The interventions demonstrated no relative advantage compared to usual home care.
","['Black and Hispanic post-stroke, home health patients, an understudied group', '495 Black and Hispanic, English and Spanish speaking adults with uncontrolled systolic blood pressure (SBP ≥ 140 mmHg) who had experienced a first-time or recurrent stroke or transient ischemic attack', 'Mean participant age was 67; 57.0% were female; 69.7% were Black, non-Hispanic; 30.3% Hispanic']","['usual home care (UHC), with b', 'UHC plus a 30-day nurse practitioner transitional care program, or c']","['change in SBP', 'SBP']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0621452', 'cui_str': 'Day Nurse'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",495.0,0.0696227,"The interventions demonstrated no relative advantage compared to usual home care.
","[{'ForeName': 'Penny H', 'Initials': 'PH', 'LastName': 'Feldman', 'Affiliation': 'Center for Home Care Policy & Research, Visiting Nurse Service of New York, New York, USA.'}, {'ForeName': 'Margaret V', 'Initials': 'MV', 'LastName': 'McDonald', 'Affiliation': 'Center for Home Care Policy & Research, Visiting Nurse Service of New York, New York, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Trachtenberg', 'Affiliation': 'Center for Home Care Policy & Research, Visiting Nurse Service of New York, New York, USA.'}, {'ForeName': 'Marygrace', 'Initials': 'M', 'LastName': 'Trifilio', 'Affiliation': 'Center for Home Care Policy & Research, Visiting Nurse Service of New York, New York, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Onorato', 'Affiliation': 'Center for Home Care Policy & Research, Visiting Nurse Service of New York, New York, USA.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Sridharan', 'Affiliation': 'Center for Home Care Policy & Research, Visiting Nurse Service of New York, New York, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Silver', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, RiverSpring Health, Bronx, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eimicke', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, RiverSpring Health, Bronx, New York, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Teresi', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, RiverSpring Health, Bronx, New York, USA.'}]",American journal of hypertension,['10.1093/ajh/hpz148']
406,30779849,"Feasibility Trial Evaluation of a Peer Volunteering Active Aging Intervention: ACE (Active, Connected, Engaged).","BACKGROUND


ACE (Active, Connected, Engaged) is a theory-informed, pragmatic intervention using peer volunteering support to promote active ageing in socially disengaged, inactive older adults. This study aimed to establish ACE's feasibility and acceptability.
METHODS


Fifty-four older adults were recruited as either peer volunteers (activators; n = 15) or participants (ACEs; n = 39). Participants were randomized to one-to-one support from an activator (ACEs-Intervention [ACEs-I]) or a waiting-list control group (ACEs-Control [ACEs-C]). Activators supported ACEs-I to get out more and engage with local activities. Objectively measured physical activity (PA), lower limb function, and number of out of house activities were assessed at baseline and post-intervention. A mixed-methods process evaluation assessed changes in confidence to get out and about, social support, autonomy, competence, and relatedness.
RESULTS


Eighty-two percent of ACEs (mean age = 73.7 years [SD 7.3]) and all activators completed assessments at both baseline and post-intervention (6 months). ACEs-I reported more out of house activities (M [SD] = 6.34 [4.15]). ACEs-I increased physical function post-intervention (M [SD] = 9.8 [2.3]). ACEs-I reported improved well-being and vitality and increased confidence to get out and about, confidence in the face of specific barriers, knowledge of local initiatives, and perceived social support post-intervention. Activators, although sufficiently active at baseline, increased their PA further. ACE was well-accepted and easy to deliver.
CONCLUSIONS


ACE is an acceptable and feasible intervention for helping socially disengaged older people to get out and about more, improve their confidence, and engage more with their community.",2020,"ACE is an acceptable and feasible intervention for helping socially disengaged older people to get out and about more, improve their confidence, and engage more with their community.","['Fifty-four older adults were recruited as either peer volunteers (activators; n = 15) or participants (ACEs; n = 39', 'Eighty-two percent of ACEs (mean age = 73.7 years [SD 7.3']","['Peer Volunteering Active Aging Intervention', 'ACE', 'activator (ACEs-Intervention [ACEs-I]) or a waiting-list control group (ACEs-Control [ACEs-C']","['confidence to get out and about, social support, autonomy, competence, and relatedness', 'Objectively measured physical activity (PA), lower limb function, and number of out of house activities']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0037438'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",54.0,0.0489529,"ACE is an acceptable and feasible intervention for helping socially disengaged older people to get out and about more, improve their confidence, and engage more with their community.","[{'ForeName': 'Afroditi', 'Initials': 'A', 'LastName': 'Stathi', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Withall', 'Affiliation': 'Department for Health, University of Bath, UK.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Thompson', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, UK.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Davis', 'Affiliation': 'Physical Activity Measurement Consultant, Bwlch, Wales, UK.'}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Jolanthe', 'Initials': 'J', 'LastName': 'De Koning', 'Affiliation': 'Department for Health, University of Bath, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Parkhurst', 'Affiliation': 'Centre for Transport and Society, Department of Geography and Environmental Management, University of the West of England, Bristol, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Lloyd', 'Affiliation': 'School of Policy Studies, University of Bristol, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Laventure', 'Affiliation': 'Later Life Training LTD, Perthshire, UK.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Fox', 'Affiliation': 'School of Policy Studies, University of Bristol, UK.'}]",The Gerontologist,['10.1093/geront/gnz003']
407,32253227,Effectiveness of a lumbopelvic monitor and feedback device to change postural behaviour: the ELF cluster randomised controlled trial.,"OBJECTIVES


The aim of this clustered, randomised controlled trial was to assess the effectiveness of a lumbopelvic postural feedback device for changing postural behaviour in a group of healthcare workers. We hypothesised that workers exposed to auditory postural feedback would reduce the number of times forward bending posture is adopted at work.
METHODS


This was a participant and assessor blinded, randomised, sham-controlled trial with blocked cluster random allocation. We recruited healthcare workers from aged care institutions. Healthcare sites were randomly allocated to the feedback or sham group (SG). A postural monitoring and feedback device was used to monitor and record lumbopelvic forward bending posture, and provided audio feedback whenever the user sustained lumbopelvic forward bending posture that exceeded predefined thresholds. The primary outcome measure was postural behaviour (exceeding thresholds). We used a robust variant of repeated measures mixed-effect model for assessing within-group and between-group differences in postural behaviour.
RESULTS


We recruited 19 sites, and 130 healthcare workers participated. There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
CONCLUSIONS


Findings from this trial indicate that audio feedback provided by a postural monitor device did not reduce the number of times healthcare workers exceeded the postural threshold.
TRIAL REGISTRATION NUMBER


ACTRN12616000449437.",2020,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
","['We recruited 19 sites, and 130 healthcare workers participated', 'healthcare workers from aged care institutions', 'Healthcare sites', 'a group of healthcare workers']","['feedback or sham group (SG', 'lumbopelvic monitor and feedback device', 'lumbopelvic postural feedback device']","['number of times postural threshold', 'postural behaviour (exceeding thresholds', 'number of times healthcare workers']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]","[{'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.253141,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
","[{'ForeName': 'Daniel Cury', 'Initials': 'DC', 'LastName': 'Ribeiro', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand daniel.ribeiro@otago.ac.nz.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Milosavljevic', 'Affiliation': 'School of Physiotherapy, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Terry', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106293']
408,32253263,Effect of State Immunization Information System Centralized Reminder and Recall on HPV Vaccination Rates.,"BACKGROUND


Although autodialer centralized reminder and recall (C-R/R) from state immunization information systems (IISs) has been shown to raise childhood vaccination rates, its impact on human papillomavirus (HPV) vaccination rates is unclear.
METHODS


In a 4-arm pragmatic randomized controlled trial across 2 states, we randomly selected practices representative of the specialty (pediatrics, family medicine, and health center) where children received care. Within each practice, patients 11 to 17.9 years old who had not completed their HPV vaccine series (NY:  N  = 30 616 in 123 practices; CO:  N  = 31 502 in 80 practices) were randomly assigned to receive 0, 1, 2, or 3 IIS C-R/R autodialer messages per vaccine dose. We assessed HPV vaccine receipt via the IIS, calculated intervention costs, and compared HPV vaccine series initiation and completion rates across study arms.
RESULTS


In New York, HPV vaccine initiation rates ranged from 37.0% to 37.4%, and completion rates were between 29.1% and 30.1%, with no significant differences across study arms. In Colorado, HPV vaccine initiation rates ranged from 31.2% to 33.5% and were slightly higher for 1 reminder compared with none, but vaccine completion rates, ranging from 27.0% to 27.8%, were similar. On adjusted analyses in Colorado, vaccine initiation rates were slightly higher for 1 and 3 C-R/R messages (adjusted risk ratios 1.07 and 1.04, respectively); completion rates were slightly higher for 1 and 3 C-R/R messages (adjusted risk ratios 1.02 and 1.03, respectively).
CONCLUSIONS


IIS-based C-R/R for HPV vaccination did not improve HPV vaccination rates in New York and increased vaccination rates slightly in Colorado.",2020,"In Colorado, HPV vaccine initiation rates ranged from 31.2% to 33.5% and were slightly higher for 1 reminder compared with none, but vaccine completion rates, ranging from 27.0% to 27.8%, were similar.","['2 states, we randomly selected practices representative of the specialty (pediatrics, family medicine, and health center) where children received care', 'patients 11 to 17.9 years old who had not completed their HPV vaccine series (NY:  N  ', '30\u2009616 in 123 practices', 'N  = 31\u2009502 in 80 practices']",[],"['Colorado, vaccine initiation rates', 'completion rates', 'HPV vaccination rates', 'vaccination rates', 'HPV vaccine initiation rates', 'HPV Vaccination Rates']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0205549', 'cui_str': 'Series'}]",[],"[{'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]",,0.434936,"In Colorado, HPV vaccine initiation rates ranged from 31.2% to 33.5% and were slightly higher for 1 reminder compared with none, but vaccine completion rates, ranging from 27.0% to 27.8%, were similar.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szilagyi', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; pszilagyi@mednet.ucla.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': 'Department of Pediatrics, School of Medicine and Dentistry, University of Rochester, Rochester, New York.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Gurfinkel', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, School of Medicine and.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Beaty', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, School of Medicine and.'}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Statistics Core and.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Statistics Core and.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rice', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, School of Medicine and.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Clinical Pharmacy and.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': 'Clinical Pharmacy and.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, Colorado.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Meldrum', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, Albany, New York; and.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Statistics Core and.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, School of Medicine and Dentistry, University of Rochester, Rochester, New York.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Schaffer', 'Affiliation': 'Department of Pediatrics, School of Medicine and Dentistry, University of Rochester, Rochester, New York.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': 'Departments of Pediatrics and.'}]",Pediatrics,['10.1542/peds.2019-2689']
409,30951193,"A phase 2, randomized trial evaluating the combination of dalantercept plus axitinib in patients with advanced clear cell renal cell carcinoma.","BACKGROUND


In a prior open-label study, the combination of dalantercept, a novel antiangiogenic targeting activin receptor-like kinase 1 (ALK1), plus axitinib was deemed safe and tolerable with a promising efficacy signal in patients with advanced renal cell carcinoma (RCC).
METHODS


In the current phase 2, randomized, double-blind, placebo-controlled study, patients with clear cell RCC previously treated with 1 prior angiogenesis inhibitor were randomized 1:1 to receive axitinib plus dalantercept versus axitinib plus placebo. Randomization was stratified by the type of prior therapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were PFS in patients with ≥2 prior lines of anticancer therapy, overall survival, and the objective response rate.
RESULTS


Between June 10, 2014, and February 23, 2017, a total of 124 patients were randomly assigned to receive axitinib plus dalantercept (59 patients) or placebo (65 patients). The median PFS was not found to be significantly different between the treatment groups (median, 6.8 months vs 5.6 months; hazard ratio, 1.11 [95% CI, 0.71-1.73; P = .670]). Neither group reached the median overall survival (hazard ratio, 1.39 [95% CI, 0.70-2.77; P = .349]). The objective response rate was 19.0% (11 of 58 patients; 95% CI, 9.9%-31.4%) in the dalantercept plus axitinib group and 24.6% (15 of 61 patients; 95% CI, 14.5%-37.3%) in the placebo plus axitinib group. At least 1 treatment-emergent adverse event of ≥grade 3 was observed in 59% of patients (34 of 58 patients) in the dalantercept group and 64% of patients (39 of 61 patients) in the placebo group. One treatment-related death occurred in the placebo plus axitinib group.
CONCLUSIONS


Although well tolerated, the addition of dalantercept to axitinib did not appear to improve treatment-related outcomes in previously treated patients with advanced RCC.",2019,"Neither group reached the median overall survival (hazard ratio, 1.39 [95% CI, 0.70-2.77; P = .349]).","['patients with advanced renal cell carcinoma (RCC', 'patients with clear cell RCC previously treated with 1 prior angiogenesis inhibitor', 'Between June 10, 2014, and February 23, 2017, a total of 124 patients', 'patients with advanced clear cell renal cell carcinoma']","['axitinib plus dalantercept', 'dalantercept plus axitinib', 'placebo', 'axitinib plus dalantercept versus axitinib plus placebo']","['progression-free survival (PFS', 'death', 'PFS in patients with ≥2 prior lines of anticancer therapy, overall survival, and the objective response rate', 'median overall survival', 'objective response rate', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4536217', 'cui_str': 'Angiogenesis inhibitor (disposition)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2981815', 'cui_str': 'dalantercept'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",124.0,0.618388,"Neither group reached the median overall survival (hazard ratio, 1.39 [95% CI, 0.70-2.77; P = .349]).","[{'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Rupal S', 'Initials': 'RS', 'LastName': 'Bhatt', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada.'}, {'ForeName': 'Mayer', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Moffit Cancer Center, Tampa, Florida.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Alter', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, Arkansas.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Penn State Cancer Institute, Hershey, Pennsylvania.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hauke', 'Affiliation': 'Nebraska Methodist Hospital, Omaha, Nebraska.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'Earle', 'Initials': 'E', 'LastName': 'Burgess', 'Affiliation': 'Levine Cancer Institute, Carolinas Medical Center, Charlotte, North Carolina.'}, {'ForeName': 'Theodore F', 'Initials': 'TF', 'LastName': 'Logan', 'Affiliation': 'Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shaffer', 'Affiliation': 'New York Oncology Hematology, Albany, New York.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nauman', 'Initials': 'N', 'LastName': 'Moazzam', 'Affiliation': 'Rocky Mountain Cancer Centers, Aurora, Colorado.'}, {'ForeName': 'Xiaosha', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Acceleron Pharma Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Glasser', 'Affiliation': 'Acceleron Pharma Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Sherman', 'Affiliation': 'Acceleron Pharma Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}]",Cancer,['10.1002/cncr.32061']
410,32255266,A Randomized Double-Blind Controlled Pilot Study Comparing Leucocyte-Rich Platelet-Rich Plasma and Corticosteroid in Caudal Epidural Injection for Complex Chronic Degenerative Spinal Pain.,"OBJECTIVES


To compare the efficacy and safety between leucocyte-rich platelet-rich plasma (LR-PRP) and corticosteroid in fluoroscopically guided caudal epidural injection for patients with complex chronic lumbar spinal pain.
STUDY DESIGN


A prospective randomized controlled double-blinded study.
METHODS


Fifty eligible patients with complex chronic degenerative spinal pain were randomly assigned with a 1:1 allocation ratio to receive caudal epidural injection of corticosteroid (triamcinolone acetonide, 60 mg) or LR-PRP (isolated from 60 mL autologous blood) under fluoroscopic guidance. Levels of low back pain, quality of life, and complications (or adverse effects) were evaluated at 1, 3, and 6 months after treatment. Pain levels and quality of life were assessed using the VAS and Short Form 36-Item Health Survey (SF-36), respectively.
RESULTS


No significant difference was shown at baseline between the 2 groups. Compared with the pretreatment values, there were significant reductions in the VAS score in both groups. A significantly lower VAS score at 1-month follow-up was detected in patients who received corticosteroid injection. However, the scores were lower in the LR-PRP group at 3- and 6-month follow-up. SF-36 responses at 6 months showed significant improvement in all domains in the LR-PRP group. There were no complications or adverse effects related to treatment at 6-month follow-up in either group.
CONCLUSIONS


Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain. However, LR-PRP is superior to corticosteroid for a longer pain-relieving effect and improvement in quality of life.",2020,Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain.,"['patients with complex chronic lumbar spinal pain', 'Complex Chronic Degenerative Spinal Pain', 'Fifty eligible patients with complex chronic degenerative spinal pain']","['autologous LR-PRP and corticosteroid', 'caudal epidural injection of corticosteroid (triamcinolone acetonide, 60mg) or LR-PRP (isolated from 60 ml autologous blood) under fluoroscopic guidance', 'leucocyte-rich platelet-rich plasma (LR-PRP) and corticosteroid', 'Leucocyte-Rich Platelet-Rich Plasma and Corticosteroid']","['VAS score', 'Pain levels and quality of life', 'Levels of low back pain, quality of life, and complications (or adverse effects', 'quality of life', 'SF-36 questionnaires', 'visual analog scale (VAS) and short form SF-36, respectively', 'complications or adverse effects', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0560563', 'cui_str': 'Fluoroscopic guidance'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.168039,Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain.,"[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ruiz-Lopez', 'Affiliation': 'Clinica Vertebra, Barcelona Spine and Pain Surgery Center, Unit of MISS, Barcelona, Spain.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology and Center of Pain Management, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12893']
411,31821491,Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial.,"BACKGROUND


There has been little research on strategies for prevention of peritoneal dialysis (PD)-related peritonitis. We explored whether regular retraining on bag exchanges (via two methods: technique inspection and oral education) every other month could help reduce the risk of peritonitis in PD patients through a randomized controlled trial (RCT).
METHOD


This is an RCT conducted at Peking University First Hospital. A total of 150 incident patients receiving PD at our centre were included between December 2010 and June 2016 and followed up until June 2018. Patients were randomly assigned 1:1:1 to receive retraining on bag exchange via technique inspection, oral education or usual care. The primary outcome was time to the first peritonitis episode. Secondary outcomes were time to organism-specific peritonitis, transfer to haemodialysis and all-cause death.
RESULTS


Patients in the technique inspection group, oral education group and usual care group (n = 50 for each group) were followed up for 47.5 ± 22.9 months. Time to first peritonitis was comparable between the groups. The technique inspection group showed a lower risk of first non-enteric peritonitis than the usual care group, while the oral education group did not show a significant benefit. The incidence of first non-enteric peritonitis in the usual care group (0.07/patient-year) was significantly higher than that in the technique inspection group (0.02/patient-year; P < 0.01) but was comparable with that in the oral education group (0.06/patient-year). Transfer to haemodialysis and all-cause mortality were not significantly different between the groups.
CONCLUSIONS


Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01621997).",2020,"Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis.
","['150 incident patients receiving PD at our centre were included between December 2010 and June 2016 and followed up until June 2018', 'Patients in the technique inspection group, oral education group and usual care group (n\u2009']","['retraining on bag exchange via technique inspection, oral education or usual care', 'peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education', 'regular retraining on bag exchanges (via two methods: technique inspection and oral education']","['time to organism-specific peritonitis, transfer to haemodialysis and all-cause death', 'lower risk of first non-enteric peritonitis', 'time to the first peritonitis episode', 'Time to first peritonitis', 'incidence of first non-enteric peritonitis', 'risk of peritonitis', 'Transfer to haemodialysis and all-cause mortality', 'risk of all-cause peritonitis', 'risk of non-enteric PD-related peritonitis']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",150.0,0.113217,"Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Zhikai', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz238']
412,32265309,Inhaled aztreonam improves symptoms of cough and sputum production in patients with bronchiectasis: a  post hoc  analysis of the AIR-BX studies.,"INTRODUCTION


Inhaled antibiotics may improve symptom scores, but it is not known which specific symptoms improve with therapy. Item-level analysis of questionnaire data may allow us to identify which specific symptoms respond best to treatment.
METHODS


Post hoc  analysis of the AIR-BX1 studies and two trials of inhaled aztreonam  versus  placebo in bronchiectasis. Individual items from the quality of life bronchiectasis (QOL-B) respiratory symptom scale, were extracted as representing severity of nine distinct symptoms. Generalised linear models were used to evaluate changes in symptoms with treatment  versus  placebo from baseline to end of first on-treatment cycle and mixed models were used to evaluate changes across the full 16-week trial.
RESULTS


Aztreonam improved cough (difference 0.22, 95% CI 0.08-0.37; p=0.002), sputum production (0.30, 95% CI 0.15-0.44; p<0.0001) and sputum colour (0.29, 95% CI 0.15-0.43; p<0.0001)  versus  placebo equating to a 20% improvement in cough and 25% improvement in sputum production and colour. Similar results were observed for cough, sputum production and sputum purulence across the trial duration (all p<0.05). Patients with higher sputum production and sputum colour scores had a greater response on the overall QOL-B (difference 4.82, 95% CI 1.12-8.53; p=0.011 for sputum production and 5.02, 95% CI 1.19-8.86; p=0.01 for sputum colour). In contrast, treating patients who had lower levels of bronchitic symptoms resulted in shorter time to next exacerbation (hazard ratio 1.83, 95% CI 1.02-3.28; p=0.042).
CONCLUSION


Baseline bronchitic symptoms predict response to inhaled aztreonam in bronchiectasis. More sensitive tools to measure bronchitic symptoms may be useful to better identify inhaled antibiotic responders and to evaluate patient response to treatment.",2020,"RESULTS


Aztreonam improved cough (difference 0.22; 95%CI 0.08-0.37, p=0.002), sputum production (0.30; 95%CI 0.15-0.44, p<0.0001) and sputum colour (0.29; 95%CI 0.15-0.43 p<0.0001)  versus  placebo equating to a 20% improvement in cough and 25% improvement in sputum production and colour respectively.","['patients with bronchiectasis', 'bronchiectasis']","['inhaled aztreonam  versus  placebo', 'placebo', 'aztreonam', 'Inhaled Aztreonam']","['bronchitic symptoms', 'cough', 'sputum colour', 'symptom scores', 'quality of life bronchiectasis respiratory symptom scale (QOL-B', 'overall QOL-B', 'cough, sputum production and sputum purulence', 'symptoms of cough and sputum production', 'sputum production']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004521', 'cui_str': 'Aztreonam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0475809', 'cui_str': 'Color of sputum'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0854358', 'cui_str': 'Purulence'}]",,0.379569,"RESULTS


Aztreonam improved cough (difference 0.22; 95%CI 0.08-0.37, p=0.002), sputum production (0.30; 95%CI 0.15-0.44, p<0.0001) and sputum colour (0.29; 95%CI 0.15-0.43 p<0.0001)  versus  placebo equating to a 20% improvement in cough and 25% improvement in sputum production and colour respectively.","[{'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Crichton', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lonergan', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Barker', 'Affiliation': 'Division of Pulmonology and Critical Care, Department of Medicine, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Sibila', 'Affiliation': 'Dept of Respiratory Medicine, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Goeminne', 'Affiliation': 'Dept of Respiratory Medicine, AZ Nikolaas, Sint-Niklaas, Belgium.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Shoemark', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}]",The European respiratory journal,['10.1183/13993003.00608-2020']
413,30816331,"Treatment of higher risk acute lymphoblastic leukemia in young people (CCG-1961), long-term follow-up: a report from the Children's Oncology Group.","Children's Cancer Group CCG-1882 improved outcome for 1-21-year old with high risk acute lymphoblastic leukemia and Induction Day 8 marrow blasts ≥25% (slow early responders, SER) with longer and stronger post induction intensification (PII). This CCG-1961 explored alternative PII strategies. We report 10-year follow-up for patients with rapid early response (RER) and for the first time details our experience for SER patients. A total of 2057 patients were enrolled, and 1299 RER patients were randomized to 1 of 4 PII regimens: standard vs. augmented intensity and standard vs. increased length. At the end of interim maintenance, 447 SER patients were randomized to idarubicin/cyclophosphamide or weekly doxorubicin in the delayed intensification phases. The 10-year EFS for RER were 79.4 ± 2.4% and 70.9 ± 2.6% (hazard ratio = 0.65, 95% CI 0.52-0.82, p < 0.001) for augmented and standard strength PII; the 10-year OS rates were 87.2 ± 2.0% and 81.0 ± 2.2% (hazard ratio = 0.64, 95% CI 0.48-0.86, p = 0.003). Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin. The EFS and OS advantage of augmented PII is sustained at 10 years for RER patients. Longer PII for RER patients and sequential idarubicin/cyclophosphamide for SER patients offered no advantage. CCG-1961 is the platform for subsequent COG studies.",2019,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","['patients with rapid early response (RER) and for the first time\xa0details our experience for SER patients', '447 SER patients', '2057 patients were enrolled, and 1299 RER patients']","['idarubicin/cyclophosphamide and weekly doxorubicin', 'idarubicin/cyclophosphamide or weekly doxorubicin', 'idarubicin/cyclophosphamide', 'CCG-1961']","['10-year OS rates', '10-year EFS for RER']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2057.0,0.0559644,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Steinherz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. steinhep@mskcc.org.'}, {'ForeName': 'Nita L', 'Initials': 'NL', 'LastName': 'Seibel', 'Affiliation': ""Children's National Health System, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.""}, {'ForeName': 'Harland', 'Initials': 'H', 'LastName': 'Sather', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Gaynon', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}]",Leukemia,['10.1038/s41375-019-0422-z']
414,32251641,"Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial.","BACKGROUND


A monovalent, parenteral, subunit rotavirus vaccine was well tolerated and immunogenic in adults in the USA and in toddlers and infants in South Africa, but elicited poor responses against heterotypic rotavirus strains. We aimed to evaluate safety and immunogenicity of a trivalent vaccine formulation (P2-VP8-P[4],[6],[8]).
METHODS


A double-blind, randomised, placebo-controlled, dose-escalation, phase 1/2 study was done at three South African research sites. Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment. In the dose-escalation phase, adults and toddlers were randomly assigned in blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo. In the expanded phase, infants were randomly assigned in a 1:1:1:1 ratio to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo, in block sizes of four. Participants, parents of participants, and clinical, data, and laboratory staff were masked to treatment assignment. Adults received an intramuscular injection of vaccine or placebo in the deltoid muscle on the day of randomisation (day 0), day 28, and day 56; toddlers received a single injection of vaccine or placebo in the anterolateral thigh on day 0. Infants in both phases received an injection of vaccine or placebo in the anterolateral thigh on days 0, 28, and 56, at approximately 6, 10, and 14 weeks of age. Primary safety endpoints were local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events within 28 days after each injection in all participants who received at least one injection. Primary immunogenicity endpoints were analysed in infants in either phase who received all planned injections, had blood samples analysed at the relevant timepoints, and presented no major protocol violations considered to have an effect on the immunogenicity results of the study, and included serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses measured 4 weeks after the final injection in vaccine compared with placebo groups. This trial is registered with ClinicalTrials.gov, NCT02646891.
FINDINGS


Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group, 140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group) were randomly assigned, received at least one dose, and were assessed for safety. There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups. There were no serious adverse events within 28 days of injection in adults, whereas one serious adverse event occurred in a toddler (febrile convulsion in the 30 μg group) and 23 serious adverse events (four in placebo, ten in 15 μg, four in 30 μg, and five in 90 μg groups) occurred among 20 infants, most commonly respiratory tract infections. One death occurred in an infant within 28 days of injection due to pneumococcal meningitis. In 528 infants (130 in placebo, 132 in 15 μg, 132 in 30 μg, and 134 in 90 μg groups), adjusted anti-P2-VP8 IgG seroresponses (≥4-fold increase from baseline) to P[4], P[6], and P[8] antigens were significantly higher in the 15 μg, 30 μg, and 90 μg groups (99-100%) than in the placebo group (10-29%; p<0·0001). Although significantly higher than in placebo recipients (9-10%), anti-P2-VP8 IgA seroresponses (≥4-fold increase from baseline) to each individual antigen were modest (20-34%) across the 15 μg, 30 μg, and 90 μg groups. Adjusted neutralising antibody seroresponses in infants (≥2·7-fold increase from baseline) to DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]) were higher in vaccine recipients than in placebo recipients: p<0·0001 for all comparisons.
INTERPRETATION


The trivalent P2-VP8 vaccine was well tolerated, with promising anti-P2-VP8 IgG and neutralising antibody responses across the three vaccine P types. Our findings support advancing the vaccine to efficacy testing.
FUNDING


Bill & Melinda Gates Foundation.",2020,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","['528 infants (130 in', '140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group', ""Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment"", 'adults in the USA and in toddlers and infants in South Africa', 'Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group', 'three South African research sites', 'adults and toddlers']","['vaccine or placebo', 'parenteral trivalent P2-VP8 subunit rotavirus vaccine', 'placebo', 'intramuscular injection of vaccine or placebo', 'vaccine, or placebo', 'blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo', 'trivalent vaccine formulation (P2-VP8-P[4],[6],[8']","['serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses', 'serious adverse events', 'One death', 'local or systemic adverse events, or unsolicited adverse events', 'safety and immunogenicity', 'Safety and immunogenicity', '23 serious adverse events', 'Adjusted neutralising antibody seroresponses', 'local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events', 'adjusted anti-P2-VP8 IgG seroresponses', 'anti-P2-VP8 IgA seroresponses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",4.0,0.743237,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Groome', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: groomem@rmpru.co.za.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Family Clinical Research Unit, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Maysseb', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'PATH, Washington, DC, USA; Novavax, Gaithersburg, MD, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Power', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cryz', 'Affiliation': 'PATH, Washington, DC, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30001-3']
415,32083990,Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.,"PURPOSE


MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen.
PATIENTS AND METHODS


R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m 2  intravenously plus oral capecitabine 825 mg/m 2  two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety.
RESULTS


Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%]  v  88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15];  P  = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1%  v  88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1%  v  11.2%) and more grade 2 hand/foot syndrome (28.5%  v  3.3%) and diarrhea (13.7%  v  5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2  v  1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]).
CONCLUSION


Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.",2020,"Overall survival (HR, 0.91","['R-C randomly assigned patients 1:1 between', 'Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC', 'Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2  v  1', 'Of 2,832 patients, 1,301 (45', 'patients with early breast cancer at high clinical but low genomic risk']","['standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m 2  intravenously plus oral capecitabine', 'docetaxel-capecitabine with an anthracycline-based regimen', 'taxanes', 'anthracycline-based chemotherapy', 'Standard Anthracycline Based Versus Docetaxel-Capecitabine']","['grade 2 hand/foot syndrome', 'diarrhea', 'DFS events', 'overall survival and safety', 'grade 1 neuropathy', 'Overall survival', 'disease-free survival (DFS', 'deaths', 'Serious cardiac events']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",148.0,0.127737,"Overall survival (HR, 0.91","[{'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Emiel', 'Initials': 'E', 'LastName': 'Rutgers', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""van 't Veer"", 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Franchette', 'Initials': 'F', 'LastName': 'van den Berkmortel', 'Affiliation': 'Zuyderland Medisch Centrum, Heerlen-Geleen, the Netherlands.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Dudek-Peric', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""Institut Catala D'Oncologia-Institut d'Investigacio Biomedica de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': ""Hospital General Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Zaman', 'Initials': 'Z', 'LastName': 'Khalil', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Knox', 'Affiliation': 'Europa Donna-The European Breast Cancer Coalition, Milan, Italy.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': 'Breast Unit Kliniken Essen-Mitte, Westdeutsche Studiengruppe, Mönchengladbach, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Kunz', 'Affiliation': 'St Johannes Hospital, Dortmund, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lesur', 'Affiliation': 'Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ravdin', 'Affiliation': 'The University of Texas Health Sciences Center, San Antonio, TX.'}, {'ForeName': 'Isabel T', 'Initials': 'IT', 'LastName': 'Rubio', 'Affiliation': 'Clinica Universidad de Navarra-Site Madrid, Madrid, Spain.'}, {'ForeName': 'Mahasti', 'Initials': 'M', 'LastName': 'Saghatchian', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Tineke J', 'Initials': 'TJ', 'LastName': 'Smilde', 'Affiliation': ""Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor University College of Medicine, Houston, TX.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'University of Milan and European Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Zoppoli', 'Affiliation': 'University of Genoa and Azienda Ospedaliera Universitaria San Martino, Genova, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'Centre Hospitalier Universitaire, Université Catholique de Louvain, Namur, Belgium.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tryfonidis', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bogaerts', 'Affiliation': 'European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01371']
416,32091599,A randomized clinical trial of the effects of leafy green vegetables and inorganic nitrate on blood pressure.,"BACKGROUND


A diet rich in fruits and vegetables is associated with lowering of blood pressure (BP), but the nutrient(s) responsible for these effects remain unclear. Research suggests that inorganic nitrate present in leafy green vegetables is converted into NO in vivo to improve cardiovascular function.
OBJECTIVE


In this study, we evaluated the effect of leafy green vegetables on BP in subjects with elevated BP, with the aim of elucidating if any such effect is related to their high nitrate content.
DESIGN


We enrolled 243 subjects, 50-70 y old, with a clinic systolic BP (SBP) of 130-159 mm Hg. After a 2-wk run-in period on a nitrate-restricted diet the subjects were randomly assigned to receive 1 of the following 3 interventions daily for 5 wk: low-nitrate vegetables + placebo pills, low-nitrate vegetables + nitrate pills (300 mg nitrate), or leafy green vegetables containing 300 mg nitrate + placebo pills. The primary end point measure was the difference in change in 24 h ambulatory SBP between the groups.
RESULTS


A total of 231 subjects (95%) completed the study. The insignificant change in ambulatory SBP (mean ± standard deviation) was -0.6 ± 6.2 mm Hg in the placebo group, -1.2 ± 6.8 mm Hg in the potassium nitrate group, and -0.5 ± 6.6 mm Hg in the leafy green vegetable group. There was no significant difference in change between the 3 groups.
CONCLUSIONS


A 5-wk dietary supplementation with leafy green vegetables or pills containing the same amount of inorganic nitrate does not decrease ambulatory SBP in subjects with elevated BP. This trial was registered at clinicaltrials.gov as NCT02916615.",2020,"There was no significant difference in change between the 3 groups.
","['subjects with elevated BP', '231 subjects (95%) completed the study', 'We enrolled 243 subjects, 50-70 y old, with a clinic systolic BP (SBP) of 130-159\xa0mm Hg']","['low-nitrate vegetables\xa0+\xa0placebo pills, low-nitrate vegetables\xa0+\xa0nitrate pills (300\xa0mg nitrate), or leafy green vegetables containing 300\xa0mg nitrate\xa0+\xa0placebo pills', 'placebo', 'leafy green vegetables', 'leafy green vegetables and inorganic nitrate']","['ambulatory SBP (mean ± standard deviation', 'change in 24\xa0h ambulatory SBP', 'blood pressure (BP', 'blood pressure', 'ambulatory SBP']","[{'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",243.0,0.154485,"There was no significant difference in change between the 3 groups.
","[{'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'Sundqvist', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Filip J', 'Initials': 'FJ', 'LastName': 'Larsen', 'Affiliation': 'Department of Sport and Health Sciences, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Carlström', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Division of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pernow', 'Affiliation': 'Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Lundberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa024']
417,32097450,"Effects of whole-grain wheat, rye, and lignan supplementation on cardiometabolic risk factors in men with metabolic syndrome: a randomized crossover trial.","BACKGROUND


A whole-grain (WG)-rich diet has shown to have potential for both prevention and treatment of the metabolic syndrome (MetS), which is a cluster of risk factors that increase the risk of type 2 diabetes and cardiovascular disease. Different WGs may have different health effects. WG rye, in particular, may improve glucose homeostasis and blood lipids, possibly mediated through fermentable dietary fiber and lignans. Recent studies have also suggested a crucial role of the gut microbiota in response to WG.
OBJECTIVES


The aim was to investigate WG rye, alone and with lignan supplements [secoisolariciresinol diglucoside (SDG)], and WG wheat diets on glucose tolerance [oral-glucose-tolerance test (OGTT)], other cardiometabolic outcomes, enterolignans, and microbiota composition. Moreover, we exploratively evaluated the role of gut microbiota enterotypes in response to intervention diets.
METHODS


Forty men with MetS risk profile were randomly assigned to WG diets in an 8-wk crossover study. The rye diet was supplemented with 280 mg SDG at weeks 4-8. Effects of treatment were evaluated by mixed-effects modeling, and effects on microbiota composition and the role of gut microbiota as a predictor of response to treatment were analyzed by random forest plots.
RESULTS


The WG rye diet (± SDG supplements) did not affect the OGTT compared with WG wheat. Total and LDL cholesterol were lowered (-0.06 and -0.09 mmol/L, respectively; P < 0.05) after WG rye compared with WG wheat after 4 wk but not after 8 wk. WG rye resulted in higher abundance of Bifidobacterium [fold-change (FC) = 2.58, P < 0.001] compared with baseline and lower abundance of Clostridium genus compared with WG wheat (FC = 0.54, P = 0.02). The explorative analyses suggest that baseline enterotype is associated with total and LDL-cholesterol response to diet.
CONCLUSIONS


WG rye, alone or with SDG supplementation, compared with WG wheat did not affect glucose metabolism but caused transient LDL-cholesterol reduction. The effect of WG diets appeared to differ according to enterotype. This trial was registered at www.clinicaltrials.gov as NCT02987595.",2020,"Total and LDL cholesterol were lowered (-0.06 and -0.09 mmol/L, respectively; P < 0.05) after WG rye compared with WG wheat after 4 wk but not after 8 wk.","['Forty men with MetS risk profile', 'men with metabolic syndrome']","['WG)-rich diet', 'lignan supplements [secoisolariciresinol diglucoside (SDG', 'WG rye, alone or with SDG supplementation', 'whole-grain ', 'whole-grain wheat, rye, and lignan supplementation']","['glucose metabolism', 'glucose homeostasis and blood lipids', 'cardiometabolic risk factors', 'Total and LDL cholesterol', 'transient LDL-cholesterol reduction', 'glucose tolerance [oral-glucose-tolerance test (OGTT)], other cardiometabolic outcomes, enterolignans, and microbiota composition', 'total and LDL-cholesterol response', 'higher abundance of Bifidobacterium [fold-change (FC']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1140674', 'cui_str': 'Rye'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",40.0,0.116774,"Total and LDL cholesterol were lowered (-0.06 and -0.09 mmol/L, respectively; P < 0.05) after WG rye compared with WG wheat after 4 wk but not after 8 wk.","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Eriksen', 'Affiliation': 'Department of Molecular Sciences, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Brunius', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mazidi', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Hellström', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Risérus', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Kia N', 'Initials': 'KN', 'LastName': 'Iversen', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Fristedt', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Molecular Sciences, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Animal Nutrition and Management, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Natalja P', 'Initials': 'NP', 'LastName': 'Nørskov', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Knud Erik B', 'Initials': 'KEB', 'LastName': 'Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Kyrø', 'Affiliation': 'Unit of Diet, Genes and Environment, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Unit of Diet, Genes and Environment, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tjønneland', 'Affiliation': 'Unit of Diet, Genes and Environment, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Dicksved', 'Affiliation': 'Department of Animal Nutrition and Management, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa026']
418,30272127,Dissociable Roles Within the Social Brain for Self-Other Processing: A HD-tDCS Study.,"Theories of right temporoparietal junction (rTPJ) function in social cognition include self-other distinction, self-inhibition, or embodied rotation, whereas the dorsomedial prefrontal cortex (dmPFC) is associated with integrating social information. However, no study has provided causal evidence for dissociable roles of the rTPJ and dmPFC in social cognition. A total of 52 healthy young adults were stratified to receive either dmPFC or rTPJ anodal high-definition transcranial direct current stimulation (HD-tDCS) in a sham-controlled, double-blinded, repeated measures design. Self-other processing was assessed across implicit and explicit level 1 (line-of-sight) and level 2 (mental rotation) visual perspective taking (VPT) tasks, and self-other effects on memory. DmPFC stimulation selectively increased the influence of the allocentric perspective during egocentric perspective taking, indexed by an increase in congruency effect across explicit VPT tasks. Moreover, dmPFC stimulation removed the self-reference effect in episodic memory by increasing the recognition of other and decreasing the recognition of self-encoded words. Stimulation of the rTPJ resulted in improved inhibition of the egocentric-perspective during level 2 VPT only, indexed by a reduction of the congruency effect when taking the allocentric perspective. This research supports theories suggesting that the rTPJ facilitates embodied mental rotation of the self into an alternate perspective, whereas the dmPFC integrates social information relevant to self-directed processes.",2019,"Stimulation of the rTPJ resulted in improved inhibition of the egocentric-perspective during level 2 VPT only, indexed by a reduction of the congruency effect when taking the allocentric perspective.",['52 healthy young adults'],"['dmPFC or rTPJ anodal high-definition transcranial direct current stimulation (HD-tDCS', 'rTPJ']","['implicit and explicit level 1 (line-of-sight) and level 2 (mental rotation) visual perspective taking (VPT) tasks, and self-other effects on memory']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",52.0,0.0335854,"Stimulation of the rTPJ resulted in improved inhibition of the egocentric-perspective during level 2 VPT only, indexed by a reduction of the congruency effect when taking the allocentric perspective.","[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane, Queensland, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hunold', 'Affiliation': 'Technische Universität Ilmenau, Institute of Biomedical Engineering and Informatics, Ilmenau, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane, Queensland, Australia.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhy238']
419,32252963,Effectiveness of transcutaneous tibial nerve stimulation at two different thresholds for overactive bladder symptoms in older women: a randomized controlled clinical trial.,"OBJECTIVES


To compare the effectiveness of transcutaneous tibial nerve stimulation (TTNS) at two different current amplitude thresholds (sensory and motor) in terms of urinary habit, symptoms and the degree of discomfort of overactive bladder (OAB) in older women.
STUDY DESIGN


This is a randomized, controlled, 3-arm blinded trial. One hundred and one patients attending secondary care with OAB were randomized into one of three groups: group 1, TTNS sensitivity threshold (n = 39); group 2, TTNS motor threshold (n = 33); and control group 3 (n = 29).
MAIN OUTCOME MEASURES


Participants allocated to groups 1 and 2 had 8 sessions of TTNS for 30 min, twice a week. Group 3 received no intervention. The results measured were the symptoms of overactive bladder (ICIQ-OAB, overall score), bother scales (to indicate the impact of individual symptoms for the patient) and urinary habit (3-day bladder diary). A blind assessor measured outcomes at baseline and 5 weeks after randomization.
RESULTS


After five weeks, a statistically significant difference between group 3 (control) and group 1 (TTNS sensitivity threshold) and group 2 (TTNS motor threshold) was observed in the intergroup analysis, but no difference in the outcomes analyzed was detected between the two groups receiving intervention (groups 1 and 2).
CONCLUSION


TTNS is effective in the treatment of OAB in older women, with no difference between the sensitivity and motor thresholds.
CLINICAL TRIAL REGISTRATION NUMBER


Registro Brasileiros de Ensaios Clínicos (RBR-39DZ5V).",2020,"TTNS is effective in the treatment of OAB in older women, with no difference between the sensitivity and motor thresholds.
","['One hundred and one patients attending secondary care with OAB', 'older women']","['transcutaneous tibial nerve stimulation', 'TTNS sensitivity threshold (n\u2009=\u200939); group 2, TTNS motor threshold', 'TTNS', 'transcutaneous tibial nerve stimulation (TTNS']","['urinary habit, symptoms and the degree of discomfort of overactive bladder (OAB', 'urinary habit (3-day bladder diary', 'overactive bladder symptoms', 'symptoms of overactive bladder (ICIQ-OAB, overall score), bother scales', 'NUMBER\n\n\nRegistro Brasileiros de Ensaios Clínicos (RBR-39DZ5V']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",101.0,0.171662,"TTNS is effective in the treatment of OAB in older women, with no difference between the sensitivity and motor thresholds.
","[{'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Teixeira Alve', 'Affiliation': 'University of Brasilia, Centro Metropolitano, Conjunto A, Lote 01, Universidade De Brasília - Campus Ceilândia, Zip-code: 72220-90 Brasília, DF, Brazil. Electronic address: alinealves@unb.br.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Azevedo Garcia', 'Affiliation': 'University of Brasília, Centro Metropolitano, Conjunto A, Lote 0, Universidade De Brasília - Campus Ceilândia, Zip-code: 72220-90 Brasília, DF, Brazil. Electronic address: patriciagarcia@unbr.br.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Henriques Jácomo', 'Affiliation': 'Physiotherapist. University Hospital of Brasilia, Unit of Rehabilitation Hospital Universitário De Brasília SGAN 605, Av. L2 Norte, Unidade De Reabilitação, Zip-code: 70.840-901 Brasília, DF Brazil. Electronic address: raquel.jacomo@gmail.com.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Batista de Sousa', 'Affiliation': 'University of Brasilia, Hospital Universitário De Brasília SGAN 605, Av. L2 Norte Clínica Cirúrgica Zip-code: 70.840-901 Brasília, DF, Brazil. Electronic address: sousajb@unb.br.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Borges Gullo Ramos Pereira', 'Affiliation': 'Regional Hospital of Sobradinho, Ospital Regional De Sobradinho Quadra 12, Área Especial, Zip-code: 70.297-400 Brasília, DF, Brazil. Electronic address: lara.gullo@gmail.com.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Barbaresco Gomide Mateus', 'Affiliation': 'University of Brasília, Centro Metropolitano, Conjunto A, Lote 01, Universidade De Brasília - Campus Ceilândia, Zip-code: 72220-90 Brasília, DF, Brazil. Electronic address: lianagomide@unb.br.'}, {'ForeName': 'Margô', 'Initials': 'M', 'LastName': 'Gomes de Oliveira Karnikoskwi', 'Affiliation': 'University of Brasília, Centro Metropolitano, Conjunto A, Lote 01, Universidade De Brasília - Campus Ceilândia Zip-code: 72220-90 Brasília, DF, Brazil. Electronic address: margo@unb.br.'}]",Maturitas,['10.1016/j.maturitas.2020.02.008']
420,30664539,Pilot Trial of a Combined Cognitive Processing Therapy and Smoking Cessation Treatment.,"OBJECTIVE/BACKGROUND


Posttraumatic stress disorder (PTSD) and smoking are often comorbid. Combining PTSD and smoking cessation treatments could increase access to each treatment and could provide improved rates of smoking cessation through reductions in PTSD and depressive symptoms.
PARTICIPANTS


Participants were veterans with current PTSD who smoked cigarettes and were willing to initiate treatment for both problems.
METHOD


We conducted a randomized pilot trial (n = 40) to explore feasibility and estimate effect sizes of a treatment combining trauma-focused Cognitive Processing Therapy (CPT) with smoking cessation counseling and pharmacotherapy, relative to the same smoking cessation treatment without CPT.
RESULTS


Rates of bioverified 7-day point prevalence smoking abstinence at the end of treatment or at 6-month follow-up were similar across treatments. Relative to the comparison, the combined CPT and smoking cessation treatment were associated with moderate-to-large effect sizes at end of treatment for reductions in PTSD symptoms, Cohen's d = 0.718, 95% confidence interval (CI) = 0.078-1.358, that decreased by the 6-month follow-up, Cohen's d = 0.306, 95% CI = -0.334 to 0.946; and large reductions in depressive symptoms that were maintained to the 6-month follow-up, Cohen's d = 1.007, 95% CI = 0.367-1.647.
CONCLUSIONS


This pilot trial did not detect a difference in smoking cessation when combining CPT to smoking cessation treatment, relative to smoking cessation treatment without CPT. However, results suggest that combining CPT and smoking cessation treatment was associated with both reductions of psychiatric symptoms along with smoking abstinence rates similar to previous smoking cessation trials in veterans with PTSD.",2019,"This pilot trial did not detect a difference in smoking cessation when combining CPT to smoking cessation treatment, relative to smoking cessation treatment without CPT.","['veterans with PTSD', 'Participants were veterans with current PTSD who smoked cigarettes and were willing to initiate treatment for both problems']","['treatment combining trauma-focused Cognitive Processing Therapy (CPT) with smoking cessation counseling and pharmacotherapy, relative to the same smoking cessation treatment without CPT', 'Combined Cognitive Processing Therapy and Smoking Cessation Treatment']","['smoking cessation', 'depressive symptoms', 'psychiatric symptoms', 'Rates of bioverified 7-day point prevalence smoking abstinence']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C4521399', 'cui_str': 'LT'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0238977,"This pilot trial did not detect a difference in smoking cessation when combining CPT to smoking cessation treatment, relative to smoking cessation treatment without CPT.","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dedert', 'Affiliation': 'Durham Veterans Affairs Medical Center, Durham, NC (EAD, PAD, SMW, SDM, JCB); Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC (EAD, PAR, SMW, SDM, JCP); Veterans Affairs Mid-Atlantic Region Mental Illness Research, Education, and Clinical Center, Durham, NC (EAD, PAD, SDM, JCB); Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Transformation, Durham, NC (SMW).'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': ''}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000502']
421,31238370,Effects of Sustained Inflation or Positive Pressure Ventilation on the Release of Adrenomedullin in Preterm Infants with Respiratory Failure at Birth.,"OBJECTIVE


Delivery room (DR) management may play an important role in the development and prevention of lung injury. Therefore, in a cohort of low birth weight infants (LBW), we investigated the effects of two different lung recruitment maneuvers, such as positive pressure ventilation (PPV) and sustained inflation (SI) on adrenomedullin (AM), a well-established lung-specific vasoactive agent.
STUDY DESIGN


This is a prospective case-control randomized study in 44 LBW infants spontaneously breathing with respiratory failure at birth requiring respiratory support. LBW were randomized to receive PPV ( n  = 22) or SI ( n  = 22) support. AM was measured from blood in samples collected at birth from arterial artery (BLT0) and at 1-hour (BLT1) and at 24-hour (BLT2) from peripheral venous site. AM assessment in urine samples was performed at 1-hour (URT1) and at 24-hour (URT2).
RESULTS


No significant differences in AM ( p  > 0.05) blood (T0-T2) and urine (T1, T2) levels were observed between groups.
CONCLUSION


The present data, showing the absence of any differences in AM blood and urine levels, suggest that PPV and SI are both feasible and equally effective DR maneuvers. The findings open the way to further studies evaluating the effects of PPV and SI on short-/long-term respiratory outcome through biomarkers assessment.",2019,"No significant differences in AM ( p  > 0.05) blood (T0-T2) and urine (T1, T2) levels were observed between groups.
","['44 LBW infants spontaneously breathing with respiratory failure at birth requiring respiratory support', 'low birth weight infants (LBW', 'Preterm Infants with Respiratory Failure at Birth']","['PPV and SI', 'PPV', 'Sustained Inflation or Positive Pressure Ventilation']","['positive pressure ventilation (PPV) and sustained inflation (SI) on adrenomedullin (AM', 'blood (T0-T2) and urine (T1, T2) levels', 'AM', 'AM blood and urine levels']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}]","[{'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0215825', 'cui_str': 'Adrenomedullin (1-52)'}, {'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",44.0,0.0347267,"No significant differences in AM ( p  > 0.05) blood (T0-T2) and urine (T1, T2) levels were observed between groups.
","[{'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'La Verde', 'Affiliation': ""Neonatal Intensive Care Unit, V. Buzzi Children's Hospital, ASST-FBF-Sacco, Milan, Italy.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Franchini', 'Affiliation': ""Neonatal Intensive Care Unit, G. D'Annunzio University of Chieti, Chieti, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lapergola', 'Affiliation': ""Neonatal Intensive Care Unit, G. D'Annunzio University of Chieti, Chieti, Italy.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lista', 'Affiliation': ""Neonatal Intensive Care Unit, V. Buzzi Children's Hospital, ASST-FBF-Sacco, Milan, Italy.""}, {'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Barbagallo', 'Affiliation': 'Department of Biomedical and Biotechnological Sciences Section of Biochemistry, University of Catania, Catania, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Livolti', 'Affiliation': 'Department of Biomedical and Biotechnological Sciences Section of Biochemistry, University of Catania, Catania, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Gazzolo', 'Affiliation': ""Neonatal Intensive Care Unit, G. D'Annunzio University of Chieti, Chieti, Italy.""}]",American journal of perinatology,['10.1055/s-0039-1692133']
422,31132111,Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial.,"BACKGROUND


Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.
OBJECTIVES


This phase IIa open-labelled randomized controlled trial aimed to assess safety, efficacy, quality of life, neurotoxicity, curcuminoids, and C-X-C-motif chemokine ligand 1 (CXCL1) in patients receiving folinic acid/5-fluorouracil/oxaliplatin chemotherapy (FOLFOX) compared with FOLFOX + 2 g oral curcumin/d (CUFOX).
METHODS


Twenty-eight patients aged >18 y with a histological diagnosis of metastatic colorectal cancer were randomly assigned (1:2) to receive either FOLFOX or CUFOX. Safety was assessed by Common Toxicity Criteria-Adverse Event reporting, and efficacy via progression-free survival (PFS) and overall survival (OS). Quality of life and neurotoxicity were assessed using questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Functional Assessment of Cancer Treatment-Gynecologic Oncology Group-Neurotoxicity). Plasma curcuminoids were determined with liquid chromatography (LC) electrospray ionization tandem mass spectrometry and CXCL1 by ELISA.
RESULTS


Addition of daily oral curcumin to FOLFOX chemotherapy was safe and tolerable (primary outcome). Similar adverse event profiles were observed for both arms. In the intention-to-treat population, the HR for PFS was 0.57 (95% CI: 0.24, 1.36; P = 0.2) (median of 171 and 291 d for FOLFOX and CUFOX, respectively) and for OS was 0.34 (95% CI: 0.14, 0.82; P = 0.02) (median of 200 and 502 d for FOLFOX and CUFOX, respectively). There was no significant difference between arms for quality of life (P = 0.248) or neurotoxicity (P = 0.223). Curcumin glucuronide was detectable at concentrations >1.00 pmol/mL in 15 of 18 patients receiving CUFOX. Curcumin did not significantly alter CXCL1 over time (P = 0.712).
CONCLUSION


Curcumin is a safe and tolerable adjunct to FOLFOX chemotherapy in patients with metastatic colorectal cancer. This trial was registered at clinicaltrials.gov as NCT01490996 and at www.clinicaltrialsregister.eu as EudraCT 2011-002289-19.",2019,There was no significant difference between arms for quality of life (P = 0.248) or neurotoxicity (P = 0.223).,"['Patients with Metastatic Colorectal Cancer', 'Twenty-eight patients aged >18 y with a histological diagnosis of metastatic colorectal cancer', 'patients with metastatic colorectal cancer', 'patients receiving']","['FOLFOX or CUFOX', 'FOLFOX\xa0+\xa02 g oral curcumin/d (CUFOX', 'FOLFOX chemotherapy', 'Curcumin', 'Curcumin Combined with FOLFOX Chemotherapy', 'folinic acid/5-fluorouracil/oxaliplatin chemotherapy (FOLFOX']","['questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Functional Assessment', 'safety, efficacy, quality of life, neurotoxicity, curcuminoids, and C-X-C-motif chemokine ligand 1 (CXCL1', 'Quality of life and neurotoxicity', 'neurotoxicity', 'Common Toxicity Criteria-Adverse Event reporting, and efficacy via progression-free survival (PFS) and overall survival (OS', 'quality of life', 'CXCL1', 'Curcumin glucuronide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3885103', 'cui_str': 'curcumin glucuronide'}]",28.0,0.309742,There was no significant difference between arms for quality of life (P = 0.248) or neurotoxicity (P = 0.223).,"[{'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Howells', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Chinenye O O', 'Initials': 'COO', 'LastName': 'Iwuji', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Glen R B', 'Initials': 'GRB', 'LastName': 'Irving', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Walter', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Zahirah', 'Initials': 'Z', 'LastName': 'Sidat', 'Affiliation': 'Hope Clinical Trials Facility, Leicester Royal Infirmary, Leicester, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Griffin-Teall', 'Affiliation': 'Hope Clinical Trials Facility, Leicester Royal Infirmary, Leicester, United Kingdom.'}, {'ForeName': 'Rajinder', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Foreman', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Samita R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Morgan', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Steward', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gescher', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Thomas', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxz029']
423,30911113,"Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia.","Telomere length in chronic lymphocytic leukemia (CLL) has been shown to be of prognostic importance, but the analyses have largely been executed on heterogeneous patient cohorts outside of clinical trials. In the present study, we performed a comprehensive analysis of telomere length associations in the well characterized CLL8 trial (n = 620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n = 293). Absolute telomere length was analyzed using quantitative-PCR. Apart from identifying associations of short telomere length with adverse prognostic factors and survival, the study identified cases with 17p- and 11q- associated with TP53 and ATM loss, respectively, to have the shortest telomeres, even when these aberrations were present in small subclones. Thus, telomere shortening may precede acquisition of the high-risk aberrations, contributing to disease evolution. In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.",2019,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","['well characterized CLL8 trial (n\u2009=\u2009620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n\u2009=\u2009293', 'chronic lymphocytic leukemia (CLL', 'chronic lymphocytic leukemia']",[],"['TP53 and ATM loss', 'Absolute telomere length', 'genomic complexity']","[{'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0678214', 'cui_str': 'atmosphere (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}]",,0.0234911,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","[{'ForeName': 'Billy Michael Chelliah', 'Initials': 'BMC', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Landau', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Amaro N', 'Initials': 'AN', 'LastName': 'Taylor-Weiner', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bloehdorn', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Scheffold', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jäger', 'Affiliation': 'Department of Medicine I, Division of Hematology and Hemostaeology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Zenz', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Wenger', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wendtner', 'Affiliation': 'Klinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany. stephan.stilgenbauer@uniklinik-ulm.de.'}]",Leukemia,['10.1038/s41375-019-0446-4']
424,32253543,Energy replacement diminishes the postprandial triglyceride-lowering effect from accumulated walking in older women.,"PURPOSE


Dietary replacement of an acute exercise-induced energy deficit offsets the postprandial triglyceride (TG)-lowering effect of exercise in young boys and middle-aged men. It is unclear whether these findings are observed when exercise is accumulated in older adults. This study examined the effect of accumulating short bouts of exercise, with and without dietary replacement of an exercise-induced energy deficit, on postprandial TG in older women.
METHODS


Seventeen older women (≥ 65 years) underwent three, 8-h trials: (1) control, (2) accumulated walking and (3) accumulated walking with energy replacement. During the control trial, participants rested for 8 h. The accumulated walking trials comprised twenty 1.5 min brisk walking bouts performed at a pre-determined self-selected pace separated by 15 min seated rest. In each trial, participants consumed a standardised breakfast and lunch. The breakfast in the accumulated walking with energy replacement trial included replacement of the energy deficit (0.62 MJ, 149 kcal) induced by exercise. Venous blood samples were collected fasted and at 2, 4, 6 and 8 h after breakfast.
RESULTS


Time-averaged postprandial serum TG concentrations over 8 h were lower after accumulated walking than control and accumulated walking with energy replacement (mean ± SD: 1.46 ± 0.93 vs 1.71 ± 1.01 vs 1.60 ± 0.98 mmol/L, respectively: main effect of trial p = 0.017). There was little difference between control and accumulated walking with energy replacement.
CONCLUSIONS


Replacing the energy expenditure induced by accumulating 30 min of brisk walking in short (1.5 min) bouts diminishes the postprandial TG-lowering effect in older women.",2020,"There was little difference between control and accumulated walking with energy replacement.
","['young boys and middle-aged men', 'older women', 'Seventeen older women (≥', 'older adults']","['control, (2) accumulated walking and (3) accumulated walking with energy replacement', 'acute exercise-induced energy deficit offsets the postprandial triglyceride (TG)-lowering effect of exercise', 'accumulating short bouts of exercise, with and without dietary replacement of an exercise-induced energy deficit', 'min brisk walking bouts performed at a pre-determined self-selected pace separated by 15\xa0min seated rest']","['Venous blood samples', 'postprandial TG-lowering effect', 'postprandial triglyceride-lowering effect', 'Time-averaged postprandial serum TG concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",17.0,0.0628431,"There was little difference between control and accumulated walking with energy replacement.
","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan. m.miyashita@waseda.jp.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Hamada', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Fujihira', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Nagayama', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Organization for University Research Initiatives, Waseda University, Singapore, 139651, Singapore.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Burns', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, 637616, Singapore.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}]",European journal of nutrition,['10.1007/s00394-020-02234-z']
425,32253548,Additional benefits of multiple-dose tranexamic acid to anti-fibrinolysis and anti-inflammation in total knee arthroplasty: a randomized controlled trial.,"BACKGROUND


Consensus is lacking regarding the dose and timing of tranexamic acid (TXA). The aim of this study was to determine whether multiple-dose intravenous TXA further reduced blood loss and attenuated inflammation after total knee arthroplasty (TKA).
MATERIALS AND METHODS


We prospectively studied four regimens on TXA: no TXA (A), before incision, 3, 6, and 12 h later (B), before incision, 3, 6, 12, and 18 h later (C) and before incision, 3, 6, 12, 18, and 24 h later (D). The primary outcome was hidden blood loss (HBL). Other outcome measurements such as total blood loss (TBL), intraoperative blood loss (IBL), fibrinolysis parameters [fibrin(-ogen) degradation products, D-dimer], inflammatory factors (C-reactive protein, interleukin-6), visual analog scale (VAS) score, transfusion rate, length of stay (LOS) and complications were also compared.
RESULTS


The mean HBL and TBL were significantly lower in Group D than in Groups C, B and A. The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively. The VAS score on postoperative days 1 and 3 (POD1 and POD3) was significantly lower in Group D than in Groups C, B and A. There was no significant difference in LOS among groups. No patient underwent blood transfusion. No episodes of deep venous thrombosis or pulmonary embolism occurred in all the groups.
CONCLUSION


The repeated doses of TXA up to 24 h can further diminish HBL, provide additional fibrinolysis and inflammation control and ameliorate postoperative pain following TKA.
LEVEL OF EVIDENCE


I.",2020,"The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively.","['total knee arthroplasty (TKA', 'total knee arthroplasty']","['tranexamic acid (TXA', 'TXA: no TXA', 'tranexamic acid', 'TXA']","['mean HBL and TBL', 'VAS score on postoperative days 1 and 3 (POD1 and POD3', 'level of inflammatory factors and fibrinolysis parameters', 'blood loss', 'deep venous thrombosis or pulmonary embolism', 'LOS', 'total blood loss (TBL), intraoperative blood loss (IBL), fibrinolysis parameters [fibrin(-ogen) degradation products, D-dimer], inflammatory factors (C-reactive protein, interleukin-6), visual analog scale (VAS) score, transfusion rate, length of stay (LOS) and complications', 'hidden blood loss (HBL']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0206624', 'cui_str': 'Hepatoblastoma'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0722236', 'cui_str': 'Ogen'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205262', 'cui_str': 'Occult'}]",,0.0903729,"The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively.","[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China. huangw511@163.com.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China. peifux@126.com.""}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03442-2']
426,31483448,Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial.,"Importance


The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear.
Objective


To define patterns of recurrence after adjuvant chemotherapy and the association with survival.
Design, Setting, and Participants


Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019.
Interventions


Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine.
Main Outcomes and Measures


Overall survival, recurrence, and sites of recurrence.
Results


Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 and P = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98; P = .03).
Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection.
Trial Registration


ClinicalTrials.gov identifier: NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.",2019,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[' median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43', '730 patients who had resection and adjuvant chemotherapy for pancreatic cancer', 'Pancreatic Ductal Adenocarcinoma', '730 patients']","['Gemcitabine plus capecitabine', 'gemcitabine', 'gemcitabine or gemcitabine plus capecitabine']","['local recurrence', 'median overall survival', 'Measures\n\n\nOverall survival, recurrence, and sites of recurrence', 'overall survival', 'median survival', 'death following recurrence', 'local with distant recurrence', 'time to recurrence and subsequent and overall survival', 'Recurrence', 'distant recurrence', 'median follow-up time', 'Local recurrence', '5-year survival estimates']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",730.0,0.440122,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Jones', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Eftychia-Eirini', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ghaneh', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Halloran', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester/The Christie, Manchester, England.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, England.'}, {'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester University Foundation Trust, Manchester, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, England.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Darby', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Roopinder', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospital, Leeds, England.""}, {'ForeName': 'Pehr', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Clinical Research Sörmland, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Clinical Research Sörmland, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, England.'}, {'ForeName': 'Jakob R', 'Initials': 'JR', 'LastName': 'Izbicki', 'Affiliation': 'University of Hamburg Medical Institutions UKE, Hamburg, Germany.'}, {'ForeName': 'Gary William', 'Initials': 'GW', 'LastName': 'Middleton', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ""Guy's Hospital, London, England.""}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, London, England.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Velindre Hospital, Cardiff, Wales.'}, {'ForeName': 'Yuk', 'Initials': 'Y', 'LastName': 'Ting', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, England.'}, {'ForeName': 'Kinnari', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Churchill Hospital, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sherriff', 'Affiliation': 'Derriford Hospital, Plymouth, England.'}, {'ForeName': 'Rubin', 'Initials': 'R', 'LastName': 'Soomal', 'Affiliation': 'Jersey General Hospital, Jersey, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Borg', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'University Hospital Coventry, Coventry, England.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Markus M', 'Initials': 'MM', 'LastName': 'Lerch', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Neoptolemos', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2019.3337']
427,31603218,Semi-Automated Neurofeedback Therapy for Persistent Postconcussive Symptoms in a Military Clinical Setting: A Feasibility Study.,"INTRODUCTION


Neurofeedback therapy (NFT) has demonstrated effectiveness for reducing persistent symptoms following traumatic brain injury (TBI); however, its reliance on NFT experts for administration and high number of treatment sessions limits its use in military medicine. Here, we assess the feasibility of live Z-score training (LZT)-a variant of NFT that requires fewer treatment sessions and can be administered by nonexperts-for use in a military clinical setting.
MATERIALS AND METHODS


A single group design feasibility study was conducted to assess acceptability, tolerance, treatment satisfaction, and change in symptoms after a 6-week LZT intervention in 38 Service Members (SMs) with persistent symptoms comorbid with or secondary to mild TBI. Acceptance and feasibility were assessed using treatment completion and patients' satisfaction with treatment. To evaluate changes in symptom status, a battery of self-report questionnaires was administered at baseline, posttreatment, and 3-month follow-up to evaluate changes in psychological, neurobehavioral, sleep, pain, and headache symptoms, as well as self-efficacy in symptom management and life satisfaction.
RESULTS


Participants tolerated the treatment well and reported a positive experience. Symptom improvement was observed, including depressive, neurobehavioral, and pain-related symptoms, with effects sustained at 3-month follow-up.
CONCLUSION


LZT treatment appears to be a feasible, non-pharmacological therapy amenable to SMs. Results from this pilot study promote further investigation of LZT as an intervention for SMs with persistent symptoms following TBI.",2020,"Symptom improvement was observed, including depressive, neurobehavioral, and pain-related symptoms, with effects sustained at 3-month follow-up.
","['38 Service Members (SMs) with persistent symptoms comorbid with or secondary to mild TBI', 'Persistent Postconcussive Symptoms in a Military Clinical Setting']","['LZT', 'Semi-Automated Neurofeedback Therapy', 'live Z-score training (LZT)-a variant of NFT', 'LZT intervention', 'Neurofeedback therapy (NFT']","['psychological, neurobehavioral, sleep, pain, and headache symptoms, as well as self-efficacy in symptom management and life satisfaction', 'acceptability, tolerance, treatment satisfaction, and change in symptoms', 'Acceptance and feasibility', 'depressive, neurobehavioral, and pain-related symptoms']","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0418281,"Symptom improvement was observed, including depressive, neurobehavioral, and pain-related symptoms, with effects sustained at 3-month follow-up.
","[{'ForeName': 'Jamie N', 'Initials': 'JN', 'LastName': 'Hershaw', 'Affiliation': 'Defense and Veterans Brain Injury Center, Building 7489, Sutherland Circle, Fort Carson, Colorado 80913.'}, {'ForeName': 'Candace A', 'Initials': 'CA', 'LastName': 'Hill-Pearson', 'Affiliation': 'Defense and Veterans Brain Injury Center, Building 7489, Sutherland Circle, Fort Carson, Colorado 80913.'}, {'ForeName': 'Jorge I', 'Initials': 'JI', 'LastName': 'Arango', 'Affiliation': 'Defense and Veterans Brain Injury Center, Building 7489, Sutherland Circle, Fort Carson, Colorado 80913.'}, {'ForeName': 'Alicia R', 'Initials': 'AR', 'LastName': 'Souvignier', 'Affiliation': 'Defense and Veterans Brain Injury Center, Building 7489, Sutherland Circle, Fort Carson, Colorado 80913.'}, {'ForeName': 'Renee M', 'Initials': 'RM', 'LastName': 'Pazdan', 'Affiliation': 'Defense and Veterans Brain Injury Center, Building 7489, Sutherland Circle, Fort Carson, Colorado 80913.'}]",Military medicine,['10.1093/milmed/usz335']
428,32047925,The effect of legume supplementation on the gut microbiota in rural Malawian infants aged 6 to 12 months.,"BACKGROUND


Common bean and cowpea contain about 25% protein and 25% fiber, and are recommended as complementary foods in sub-Saharan Africa.
OBJECTIVE


The objective of this study was to determine if a daily legume supplement given to Malawian infants aged 6 to 12 mo alters the 16S configuration of the fecal microbiota as read out by amplicon sequence variants (ASVs).
METHODS


This study was conducted within the context of a randomized, double-blind, controlled clinical trial to assess whether cowpea or common bean supplementation reduced intestinal permeability or increased linear growth. There were 2 village clusters in which the study was conducted. Fresh stool collections were flash frozen from 236 infants at ≤6 time points. The stools were sequenced using Earth Microbiome project protocols and data were processed using Qiime and Qiita, open-source, validated software packages. α-diversity was measured using the Faith's test. The 16S configuration was characterized by determining the weighted UniFrac distances of the ASVs and comparing them using permutational multivariate ANOVA.
RESULTS


Among the 1249 samples analyzed, the α-diversity of the fecal microbiome was unchanged among subjects after initiation of legume supplementation. Neither cowpea nor common bean altered the overall 16S configuration at any age. The 16S configuration differed between children with adequate and poor linear growth aged from 6 to 9 mo, but no specific ASVs differed in relative abundance. The 16S configuration differed between children with normal and abnormal intestinal permeability at 9 mo, but no specific ASVs differed in relative abundance. Among categorical characteristics of the population associated with different 16S configurations, village cluster was most pronounced.
CONCLUSION


Legume supplementation in breastfed, rural African infants did not affect the structure of the gut microbial communities until the children were aged 9 mo. This trial was registered at clinicaltrials.gov as NCT02472262.",2020,"Among the 1249 samples analyzed, the α-diversity of the fecal microbiome was unchanged among subjects after initiation of legume supplementation.","['rural Malawian infants aged 6 to 12 months', 'Malawian infants aged 6 to 12 mo alters the 16S configuration of the fecal microbiota as read out by amplicon sequence variants (ASVs', 'breastfed, rural African infants']","['legume supplementation', 'Legume supplementation', 'cowpea or common bean supplementation']","['intestinal permeability', 'abnormal intestinal permeability', 'gut microbiota', 'α-diversity', 'α-diversity of the fecal microbiome']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]","[{'cui': 'C0453184', 'cui_str': 'Legumes'}, {'cui': 'C0996862', 'cui_str': 'Vigna'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]",,0.255769,"Among the 1249 samples analyzed, the α-diversity of the fecal microbiome was unchanged among subjects after initiation of legume supplementation.","[{'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Ordiz', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssen', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Humphrey', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ackermann', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Stephenson', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Agapova', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Divala', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Yankho', 'Initials': 'Y', 'LastName': 'Kaimila', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Indi', 'Initials': 'I', 'LastName': 'Trehan', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Phillip I', 'Initials': 'PI', 'LastName': 'Tarr', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Brigida', 'Initials': 'B', 'LastName': 'Rusconi', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa011']
429,32083646,Exopolysaccharides from milk fermented by lactic acid bacteria enhance dietary carotenoid bioavailability in humans in a randomized crossover trial and in rats.,"BACKGROUND


Dietary supplementation with carotenoids can have beneficial health effects, but carotenoids are poorly absorbed.
OBJECTIVES


We aimed to evaluate how milk fermented by lactic acid bacteria affects dietary carotenoid bioavailability in humans and rats and to investigate mechanisms by which active components in milk fermented by Lactobacilli enhance dietary carotenoid absorption.
METHODS


Male rats (n = 8/group) were administered β-carotene or β-carotene + fermented milk. Rats (n = 6/group) were also pretreated with ezetimibe, a cholesterol absorption inhibitor, to investigate β-carotene transport mechanisms. In humans, 3 studies were conducted using a randomized crossover method. Subjects (n = 16/study) consumed a vegetable (carrot, tomato, or spinach) drink alone or with a fermented milk drink. Blood samples were collected at various time points after consumption.
RESULTS


In rats, the serum β-carotene area under the concentration-time curve (AUC) was significantly higher for the β-carotene + fermented milk than for β-carotene only. A significant correlation (r = 0.83, P < 0.001) between the exopolysaccharide (EPS) content of fermented milk and serum β-carotene AUC was observed. Ezetimibe treatment did not suppress elevations in serum β-carotene concentrations induced by fermented milk ingestion. In humans, the incremental area under the concentration-time curve (iAUC) for β-carotene in the plasma triacylglycerol-rich lipoprotein (TRL) fraction was significantly (1.8-fold, range: 0.6-3.9) higher when carrot + fermented milk was consumed compared with carrot drink alone. A significantly (6.5-fold, range: 0.04-7.7) higher iAUC for lycopene in the plasma TRL fraction was observed for subjects who consumed tomato + fermented milk compared with tomato drink alone. A significant increase in plasma lutein in all fractions was observed after consumption of spinach + fermented milk, but not with spinach drink alone.
CONCLUSIONS


Co-ingestion of β-carotene and fermented milk significantly increased dietary β-carotene bioavailability in humans and rats. EPSs could affect the physical properties of fermented milk to enhance dietary β-carotene absorption mediated by simple diffusion mechanisms. These findings may be relevant for methods to increase dietary carotenoid bioavailability.This trial was registered at umin.ac.jp/ctr as UMIN000034838, UMIN000034839, and UMIN000034840.",2020,"In rats, the serum β-carotene area under the concentration-time curve (AUC) was significantly higher for the β-carotene + fermented milk than for β-carotene only.","['Male rats (n\xa0=\xa08/group', 'Subjects (n\xa0', 'Rats (n\xa0', 'humans and rats']","['β-carotene and fermented milk', 'Ezetimibe', 'ezetimibe', 'β-carotene or β-carotene\xa0+\xa0fermented milk', 'milk fermented by lactic acid bacteria', 'vegetable (carrot, tomato, or spinach) drink alone or with a fermented milk drink', 'Exopolysaccharides from milk fermented by lactic acid bacteria']","['plasma lutein', 'serum β-carotene concentrations', 'exopolysaccharide (EPS) content of fermented milk and serum β-carotene AUC', 'serum β-carotene area under the concentration-time curve (AUC', 'dietary carotenoid bioavailability', 'plasma TRL fraction', 'plasma triacylglycerol-rich lipoprotein (TRL) fraction', 'dietary β-carotene bioavailability']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1210581', 'cui_str': 'Lactic Acid Bacteria'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1141640', 'cui_str': 'Carrots'}, {'cui': 'C1140676', 'cui_str': 'Solanum lycopersicum'}, {'cui': 'C0242949', 'cui_str': 'Spinach'}, {'cui': 'C0556317', 'cui_str': 'Drinks alone (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]",,0.0225199,"In rats, the serum β-carotene area under the concentration-time curve (AUC) was significantly higher for the β-carotene + fermented milk than for β-carotene only.","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Morifuji', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Ichikawa', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Kitade', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fukasawa', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Asami', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Manabe', 'Affiliation': 'Division of Applied Biosciences, Graduate School of Agriculture, Kyoto University, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Sugawara', 'Affiliation': 'Division of Applied Biosciences, Graduate School of Agriculture, Kyoto University, Sakyo-ku, Kyoto, Japan.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa020']
430,30192928,Anticholinergic Amnesia is Mediated by Alterations in Human Network Connectivity Architecture.,"Disrupted cholinergic neurotransmission plays a central role in Alzheimer's disease, medication-induced memory impairment, and delirium. At the systems level, this suggests anticholinergic drugs may alter the activity and interplay of anatomically distributed neural networks critical for memory function. Using a network-sensitive imaging technique (functional connectivity MRI) and a double-blind, crossover design, we examined the consequences of anticholinergic drug administration on episodic memory and functional network architecture in a group of clinically normal elderly. We observed that low-dose scopolamine (0.2 mg IV) decreased episodic memory performance and selectively decreased connectivity strength in 3 of 7 cortical networks. Both memory and connectivity effects were independent of β-amyloid burden. Drug-induced connectivity changes within the Default and Salience networks, as well as reductions in the strength of anticorrelation between these 2 networks, were sufficient to fully statistically mediate the effects of scopolamine on memory performance. These results provide experimental support for the importance of the Default and Salience networks to memory performance and suggest scopolamine-induced amnesia is underpinned by disrupted connectivity within and between these 2 networks. More broadly, these results support the potential utility of fcMRI as tool examine the systems-level pharmacology of psychoactive drugs.",2019,We observed that low-dose scopolamine (0.2 mg IV) decreased episodic memory performance and selectively decreased connectivity strength in 3 of 7 cortical networks.,['a group of clinically normal elderly'],"['network-sensitive imaging technique (functional connectivity MRI', 'anticholinergic drug administration', 'scopolamine']","['episodic memory performance', 'connectivity strength', 'episodic memory and functional network architecture', 'memory performance']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0079595', 'cui_str': 'Imaging technique (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",7.0,0.0446424,We observed that low-dose scopolamine (0.2 mg IV) decreased episodic memory performance and selectively decreased connectivity strength in 3 of 7 cortical networks.,"[{'ForeName': 'Jasmeer P', 'Initials': 'JP', 'LastName': 'Chhatwal', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Schultz', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Trey', 'Initials': 'T', 'LastName': 'Hedden', 'Affiliation': 'Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Brendon P', 'Initials': 'BP', 'LastName': 'Boot', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wigman', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dorene', 'Initials': 'D', 'LastName': 'Rentz', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Johnson', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Reisa A', 'Initials': 'RA', 'LastName': 'Sperling', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhy214']
431,31361315,Haemodiafiltration does not lower protein-bound uraemic toxin levels compared with haemodialysis in a paediatric population.,"BACKGROUND


Haemodiafiltration (HDF) is accepted to effectively lower plasma levels of middle molecules in the long term, while data are conflicting with respect to the additive effect of convection on lowering protein-bound uraemic toxins (PBUTs). Here we compared pre-dialysis β2-microglobulin (β2M) and PBUT levels and the percentage of protein binding (%PB) in children on post-dilution HDF versus conventional high- (hf) or low-flux (lf) haemodialysis (HD) over 12 months of treatment.
METHODS


In a prospective multicentre, non-randomized parallel-arm intervention study, pre-dialysis levels of six PBUTs and β2M were measured in children (5-20 years) on post-HDF (n = 37), hf-HD (n = 42) and lf-HD (n = 18) at baseline and after 12 months. Analysis of variance was used to compare levels and %PB in post-HDF versus conventional hf-HD and lf-HD cross-sectionally at 12 months and longitudinal from baseline to 12 months.
RESULTS


For none of the PBUTs, no difference was found in either total and free plasma levels or %PB between post-HDF versus the hf-HD and lf-HD groups. Children treated with post-HDF had lower pre-dialysis β2M levels [median 23.2 (21.5; 26.6) mg/dL] after 12 months versus children on hf-HD [P<0.01; 35.2 (29.3; 41.2) mg/dL] and children on lf-HD [P<0.001; 47.2 (34.3; 53.0) mg/dL]. While β2M levels remained steady in the hf-HD and lf-HD group, a decrease in β2M was demonstrated for children on post-HDF (P<0.01).
CONCLUSIONS


While post-HDF successfully decreased β2M, no additive effect on PBUT over 12 months of treatment was found. PBUT removal is complex and hampered by several factors. In children, these factors might be different from adults and should be explored in future research.",2020,"For none of the PBUTs, no difference was found in either total and free plasma levels or %PB between post-HDF versus the hf-HD and lf-HD groups.","['children (5-20\u2009years) on post-HDF (n\u2009=\u200937), hf-HD (n\u2009=\u200942) and lf-HD (n\u2009=\u200918) at baseline and after 12\u2009months']",['conventional high- (hf) or low-flux (lf) haemodialysis (HD'],"['pre-dialysis β2M levels', 'β2M', 'total and free plasma levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.0290474,"For none of the PBUTs, no difference was found in either total and free plasma levels or %PB between post-HDF versus the hf-HD and lf-HD groups.","[{'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Snauwaert', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Van Biesen', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Raes', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Griet', 'Initials': 'G', 'LastName': 'Glorieux', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vande Walle', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Roels', 'Affiliation': 'Department of Data Analysis, Faculty of Psychology and Pedagogy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Vanholder', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Varvara', 'Initials': 'V', 'LastName': 'Askiti', 'Affiliation': ""A & P Kyriakou Children's Hospital, Athens, Greece.""}, {'ForeName': 'Karolis', 'Initials': 'K', 'LastName': 'Azukaitis', 'Affiliation': 'Clinic of Pediatrics, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Bayazit', 'Affiliation': 'Department of Pediatric Nephrology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Canpolat', 'Affiliation': 'Department of Pediatric Nephrology, Istanbul University Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Fischbach', 'Affiliation': ""Children's Dialysis Center, Strasbourg, France.""}, {'ForeName': 'Krid', 'Initials': 'K', 'LastName': 'Saoussen', 'Affiliation': 'Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Mieczyslaw', 'Initials': 'M', 'LastName': 'Litwin', 'Affiliation': ""Department of Nephrology, Kidney Transplantation and Hypertension, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Obrycki', 'Affiliation': ""Department of Nephrology, Kidney Transplantation and Hypertension, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Paglialonga', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ranchin', 'Affiliation': 'Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Samaille', 'Affiliation': 'Nephrologie pédiatrique, Hôpital Jeanne de Flandre, CHU de Lille, Lille, France.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Schaefer', 'Affiliation': 'Center for Pediatrics and Adolescent Medicine, Heidelberg, Germany.'}, {'ForeName': 'Claus Peter', 'Initials': 'CP', 'LastName': 'Schmitt', 'Affiliation': 'Center for Pediatrics and Adolescent Medicine, Heidelberg, Germany.'}, {'ForeName': 'Brankica', 'Initials': 'B', 'LastName': 'Spasojevic', 'Affiliation': ""University Children's Hospital, Belgrade, Serbia.""}, {'ForeName': 'Constantinos J', 'Initials': 'CJ', 'LastName': 'Stefanidis', 'Affiliation': ""A & P Kyriakou Children's Hospital, Athens, Greece.""}, {'ForeName': 'Rukshana', 'Initials': 'R', 'LastName': 'Shroff', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Eloot', 'Affiliation': 'Department of Internal Medicine & Pediatrics, Ghent University, Ghent, Belgium.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz132']
432,29878040,nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial.,"Background


Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC.
Patients and methods


Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m2 plus C AUC 2, nab-P 125 mg/m2 plus G 1000 mg/m2, or G 1000 mg/m2 plus C AUC 2, all on days 1, 8 q3w. Phase II primary end point: investigator-assessed progression-free survival (PFS); secondary end points included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety.
Results


In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38-0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37-0.90]; P = 0.02). OS was numerically longer with nab-P/C versus nab-P/G (median, 16.8 versus 12.1 months; HR, 0.73 [95% CI, 0.47-1.13]; P = 0.16) or G/C (median, 16.8 versus 12.6 months; HR, 0.80 [95% CI, 0.52-1.22]; P = 0.29). ORR was 73%, 39%, and 44%, respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic.
Conclusions


First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile versus nab-P/G or G/C.",2018,"PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38-0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37-0.90]; P = 0.02).","['patients with triple-negative metastatic breast cancer', '191 patients were enrolled (nab-P/C, n\u2009=\u200964; nab-P/G, n\u2009=\u200961; G/C, n\u2009=\u200966', 'Patients and methods\n\n\nPatients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1', 'patients with mTNBC']","['first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C', '\n\n\nMetastatic triple-negative breast cancer (mTNBC', 'nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin', 'nab-P 125\u2009mg/m2 plus C AUC 2, nab-P 125\u2009mg/m2 plus G 1000\u2009mg/m2, or G 1000\u2009mg/m2 plus C AUC']","['Grade ≥3 adverse events', 'OS', 'investigator-assessed progression-free survival (PFS', 'overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety', 'PFS', 'efficacy and safety', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",191.0,0.131626,"PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38-0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37-0.90]; P = 0.02).","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology PLLC, Medical Oncology, Nashville, USA. Electronic address: dyardley@tnonc.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Department of Oncology and Metabolism, Weston Park Hospital, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova and Medical Oncology 2, Istituto Oncologico Veneto, Padova, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""Medical Oncology, Ramon y Cajal University Hospital, Madrid; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': 'Hematology/Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shtivelband', 'Affiliation': 'Medical Oncology, Ironwood Physicians, PC, Chandler, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Medical Oncology, The Center for Cancer and Blood Disorders, Fort Worth, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bengala', 'Affiliation': 'Medical Oncology, Misericordia General Hospital, Grosseto, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Medical Oncology, Henry Ford Health System, Detroit, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Eakel', 'Affiliation': 'Hematology and Oncology, Florida Cancer Specialists, Sarasota, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Gynecology and Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'de la Cruz-Merino', 'Affiliation': 'Clinical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wilks', 'Affiliation': 'Hematology and Medical Oncology, Texas Oncology, San Antonio, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Hematology, Medical Oncology, Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Glück', 'Affiliation': 'GMA Early Assets, Celgene Corporation, Summit, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Celgene Corporation, Summit, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Clinical Research and Development, Hematology/Oncology, Celgene Corporation, Summit, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Barton', 'Affiliation': 'Clinical Research and Development, Hematology/Oncology, Celgene Corporation, Summit, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Cancer Center, University of Munich, Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy201']
433,32247649,Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users.,"INTRODUCTION


The use and availability of oral and inhalable products containing cannabidiol (CBD) as the principal constituent has increased with expanded cannabis/hemp legalization. However, few controlled clinical laboratory studies have evaluated the pharmacodynamic effects of oral or vaporized CBD or CBD-dominant cannabis.
METHODS


Eighteen healthy adults (9 men; 9 women) completed four, double-blind, double-dummy, drug administration sessions. Sessions were separated by ≥1 week and included self-administration of 100 mg oral CBD, 100 mg vaporized CBD, vaporized CBD-dominant cannabis (100 mg CBD; 3.7 mg THC), and placebo. Study outcomes included: subjective drug effects, vital signs, cognitive/psychomotor performance, and whole blood THC and CBD concentrations.
RESULTS


Vaporized CBD and CBD-dominant cannabis increased ratings on several subjective items (e.g., Like Drug Effect) relative to placebo. Subjective effects did not differ between oral CBD and placebo and were generally higher for CBD-dominant cannabis compared to vaporized CBD. CBD did not increase ratings for several items typically associated with acute cannabis/THC exposure (e.g., Paranoid). Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use. CBD-dominant cannabis increased heart rate compared to placebo. Cognitive/psychomotor impairment was not observed in any drug condition.
CONCLUSIONS


Vaporized CBD and CBD-dominant cannabis produced discriminable subjective drug effects, which were sometimes stronger in women, but did not produce cognitive/psychomotor impairment. Subjective effects of oral CBD did not differ from placebo. Future research should further elucidate the subjective effects of various types of CBD products (e.g., inhaled, oral, topical), which appear to be distinct from THC-dominant products.",2020,Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use.,"['infrequent cannabis users', 'Eighteen healthy adults (9 men; 9 women']","['placebo', 'oral CBD', 'oral and inhalable products containing cannabidiol (CBD', 'CBD', 'vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis', 'oral CBD, 100 mg vaporized CBD, vaporized CBD-dominant cannabis (100 mg CBD; 3.7 mg THC), and placebo']","['several subjective items', 'Subjective effects', 'Cognitive/psychomotor impairment', 'subjective drug effects, vital signs, cognitive/psychomotor performance, and whole blood THC and CBD concentrations', 'CBD-dominant cannabis', 'heart rate']","[{'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",18.0,0.0867755,Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use.,"[{'ForeName': 'Tory R', 'Initials': 'TR', 'LastName': 'Spindle', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA. Electronic address: tspindle@jhmi.edu.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Cone', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Goffi', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Weerts', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., NC, 27709, USA.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Winecker', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., NC, 27709, USA.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Flegel', 'Affiliation': 'Substance Abuse and Mental Health Services Administration (SAMHSA), Division of Workplace Programs (DWP), 5600Fishers Lane, Rockville, MD, 20857, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107937']
434,32247714,Effect of Intermittent or Continuous Feed on Muscle Wasting in Critical Illness: A Phase 2 Clinical Trial.,"BACKGROUND


Acute skeletal muscle wasting in critical illness is associated with excess morbidity and mortality. Continuous feeding may suppress muscle protein synthesis as a result of the muscle-full effect, unlike intermittent feeding, which may ameliorate it.
RESEARCH QUESTION


Does intermittent enteral feed decrease muscle wasting compared with continuous feed in critically ill patients?
STUDY DESIGN AND METHODS


In a phase 2 interventional single-blinded randomized controlled trial, 121 mechanically ventilated adult patients with multiorgan failure were recruited following prospective informed consultee assent. They were randomized to the intervention group (intermittent enteral feeding from six 4-hourly feeds per 24 h, n = 62) or control group (standard continuous enteral feeding, n = 59). The primary outcome was 10-day loss of rectus femoris muscle cross-sectional area determined by ultrasound. Secondary outcomes included nutritional target achievements, plasma amino acid concentrations, glycemic control, and physical function milestones.
RESULTS


Muscle loss was similar between arms (-1.1% [95% CI, -6.1% to -4.0%]; P = .676). More intermittently fed patients received 80% or more of target protein (OR, 1.52 [1.16-1.99]; P < .001) and energy (OR, 1.59 [1.21-2.08]; P = .001). Plasma branched-chain amino acid concentrations before and after feeds were similar between arms on trial day 1 (71 μM [44-98 μM]; P = .547) and trial day 10 (239 μM [33-444 μM]; P = .178). During the 10-day intervention period the coefficient of variation for glucose concentrations was higher with intermittent feed (17.84 [18.6-20.4]) vs continuous feed (12.98 [14.0-15.7]; P < .001). However, days with reported hypoglycemia and insulin usage were similar in both groups. Safety profiles, gastric intolerance, physical function milestones, and discharge destinations did not differ between groups.
INTERPRETATION


Intermittent feeding in early critical illness is not shown to preserve muscle mass in this trial despite resulting in a greater achievement of nutritional targets than continuous feeding. However, it is feasible and safe.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT02358512; URL: www.clinicaltrials.gov.",2020,Plasma branched-chain amino acid concentrations before and after feeds were similar between arms on trial day 1 (71 μM (44-98); p=0.547) and trial day 10 (239 μM (33-444); p=0.178).,"['121 mechanically-ventilated adult patients with multi-organ failure', 'muscle wasting in critical illness', 'critically ill patients']","['intermittent or continuous feed', 'control group (standard continuous enteral feeding']","['Safety profiles, gastric intolerance, physical function milestones and discharge destinations', 'Plasma branched-chain amino acid concentrations', 'hypoglycaemia and insulin usage', 'Muscle loss', 'coefficient of variation for glucose concentrations', 'nutritional target achievements, plasma amino acid concentrations, glycaemic control and physical function milestones', 'day loss of rectus femoris muscle cross-sectional area determined by ultrasound']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",121.0,0.179377,Plasma branched-chain amino acid concentrations before and after feeds were similar between arms on trial day 1 (71 μM (44-98); p=0.547) and trial day 10 (239 μM (33-444); p=0.178).,"[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'McNelly', 'Affiliation': 'William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; University College London (UCL), London, United Kingdom; National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at UCL Hospitals NHS Foundation Trust, London, United Kingdom. Electronic address: angela.mcnelly@qmul.ac.uk.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Bear', 'Affiliation': ""Department of Nutrition and Dietetics, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom; Department of Critical Care, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom; NIHR BRC, King's College London, London, United Kingdom.""}, {'ForeName': 'Bronwen A', 'Initials': 'BA', 'LastName': 'Connolly', 'Affiliation': ""NIHR BRC, King's College London, London, United Kingdom; Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Arbane', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Allum', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Tarbhai', 'Affiliation': 'University College London (UCL), London, United Kingdom.'}, {'ForeName': 'Jackie A', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'University College London (UCL), London, United Kingdom.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Hopkins', 'Affiliation': 'Kings College Hospital, London, United Kingdom.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'University Hospital of Wales, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brealey', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at UCL Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': 'Rooney', 'Affiliation': 'Bristol Royal Infirmary, Bristol, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cupitt', 'Affiliation': 'Blackpool Victoria Hospital, Blackpool, United Kingdom.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': 'University Hospitals of North Midlands, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Koelfat', 'Affiliation': 'Department of Surgery and School of Nutrition and Translational Research in Metabolism (NUTRIM), University of Maastricht, Maastricht, The Netherlands.'}, {'ForeName': 'Steven Olde', 'Initials': 'SO', 'LastName': 'Damink', 'Affiliation': 'Department of Surgery and School of Nutrition and Translational Research in Metabolism (NUTRIM), University of Maastricht, Maastricht, The Netherlands; Department of General, Visceral and Transplantation Surgery, RWTH University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Medical Research Council/Arthritis Research UK Centre for Musculoskeletal Aging, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Hugh E', 'Initials': 'HE', 'LastName': 'Montgomery', 'Affiliation': 'University College London (UCL), London, United Kingdom; National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at UCL Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Zudin A', 'Initials': 'ZA', 'LastName': 'Puthucheary', 'Affiliation': 'Adult Critical Care Unit, Royal London Hospital, London, United Kingdom; William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}]",Chest,['10.1016/j.chest.2020.03.045']
435,31621884,A Pilot Trial of Online Training for Family Well-Being and Veteran Treatment Initiation for PTSD.,"INTRODUCTION


Family members are important supports for veterans with Posttrauamtic Stress Disroder (PTSD), but they often struggle with their own distress and challenges. The Veterans Affairs-Community Reinforcement and Family Training (VA-CRAFT) website was designed to teach family members of veterans with PTSD effective ways to interact with their veterans to encourage initiation of mental health services as well as to care for themselves and improve their relationships. This article presents a pilot investigation of VA-CRAFT.
MATERIALS AND METHOD


Spouse/partners of veterans who had screened positive for PTSD but were not in mental health treatment were randomized to either use the VA-CRAFT website (n = 22) or to a waitlist control condition (n = 19) for 3 months. Veteran mental health service initiation was assessed posttreatment. Spouse/partner distress, caregiver burden, quality of life, and relationship quality were assessed pre and posttreatment. The study was approved by the Minneapolis VA Health Care System Institutional Review Board (IRB).
RESULTS


Differences between groups on veteran treatment initiation were small (Phi = 0.17) and not statistically significant. VA-CRAFT participants reported large and statistically significantly greater decreases in overall caregiver burden (η2 = 0.10) and objective caregiver burden (η2 = 0.14) than control participants. Effects were larger for those with greater initial distress. Effects sizes for other partner outcomes were negligible (η2 = 0.01) to medium (η2 = 0.09) and not statistically significant. Postintervention interviews suggested that only 33% of the VA-CRAFT participants talked with their veterans about starting treatment for PTSD during the trial.
CONCLUSION


Results from this pilot trial suggest that VA-CRAFT holds initial promise in reducing caregiver burden and as such it could be a useful resource for family members of veterans with PTSD. However, VA-CRAFT does not enhance veteran treatment initiation. It may benefit from enhancements to increase effectiveness and caregiver engagement.",2020,VA-CRAFT participants reported large and statistically significantly greater decreases in overall caregiver burden (η2 = 0.10) and objective caregiver burden (η2 = 0.14) than control participants.,"['Spouse/partners of veterans who had screened positive for PTSD but were not in mental health treatment', 'family members of veterans with PTSD', 'veterans with Posttrauamtic Stress Disroder (PTSD']","['Online Training', 'VA-CRAFT', 'VA-CRAFT website (n\xa0=\xa022) or to a waitlist control condition']","['Spouse/partner distress, caregiver burden, quality of life, and relationship quality', 'objective caregiver burden', 'overall caregiver burden']","[{'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034380'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0361199,VA-CRAFT participants reported large and statistically significantly greater decreases in overall caregiver burden (η2 = 0.10) and objective caregiver burden (η2 = 0.14) than control participants.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Erbes', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kuhn', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Polusny', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.'}, {'ForeName': 'Josef I', 'Initials': 'JI', 'LastName': 'Ruzek', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Spoont', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Meis', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gifford', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Weingardt', 'Affiliation': 'Pear Therapeutics, 201 Mission St., San Francisco, CA 94105.'}, {'ForeName': 'Emily Hagel', 'Initials': 'EH', 'LastName': 'Campbell', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Oleson', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Taylor', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis, MN 55417.'}]",Military medicine,['10.1093/milmed/usz326']
436,29893790,"Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial.","Background


The activity of palbociclib as a single agent in advanced breast cancer has not been extensively studied, with the only available clinical data limited to heavily pretreated patients. Preclinical data suggests palbociclib may partially reverse endocrine resistance, though this hypothesis has not been evaluated in previous clinical studies. This phase II, open-label, multicenter study examined the activity of palbociclib monotherapy, as well as palbociclib given in combination with the same endocrine therapy (ET) that was received prior to disease progression, in postmenopausal women with moderately pretreated, estrogen receptor-positive, HER2 negative advanced breast cancer.
Patients and methods


Eligible women with advanced disease which had progressed on one or two prior ETs were randomized 1 : 1 to receive either palbociclib alone, or palbociclib in combination with the ET as previously received. Primary end point was clinical benefit rate (CBR); secondary end points included progression-free survival (PFS).
Results


Between October 2012 and July 2016, a total of 115 patients were randomized. The CBR was 54% [95% confidence interval (CI): 41.5-63.7] for combination therapy, and 60% (95% CI: 47.8-72.9) for monotherapy. Median PFS was 10.8 months (95% CI: 5.6-12.7) for combination therapy, and 6.5 months (95% CI: 5.4-8.5) for monotherapy [hazard ratio (HR) 0.69; 95% CI: 0.4-1.1, exploratory P-value = 0.12]. Exploratory analyses revealed the PFS advantage for combination therapy was seen in the subgroup of patients who received prior ET for >6 months (HR 0.53; 95% CI: 0.3-0.9, exploratory P-value = 0.02), but not in those who received prior ET for ≤6 months.
Conclusion


Palbociclib has clinical activity as a single agent in women with moderately pretreated, oestrogen receptor-positive, HER2-negative advanced breast cancer. Palbociclib may have potential to reverse endocrine resistance in patients with a history of previous durable response to ET.
Clinical trial information


NCT02549430.",2018,"Median PFS was 10.8 months (95% CI: 5.6-12.7) for combination therapy, and 6.5 months (95% CI: 5.4-8.5) for monotherapy [hazard ratio (HR) 0.69; 95% CI: 0.4-1.1, exploratory P-value = 0.12].","['women with moderately pretreated, oestrogen receptor-positive, HER2-negative advanced breast cancer', 'Results\n\n\nBetween October 2012 and July 2016, a total of 115 patients were randomized', 'advanced breast cancer', 'postmenopausal women with moderately pretreated, estrogen receptor-positive, HER2 negative advanced breast cancer', 'patients with a history of previous durable response to ET', 'Patients and methods\n\n\nEligible women with advanced disease which had progressed on one or two prior ETs']","['palbociclib alone, or palbociclib in combination with the ET', 'endocrine therapy', 'palbociclib given in combination with the same endocrine therapy (ET']","['Median PFS', 'CBR', 'PFS advantage for combination therapy', 'clinical benefit rate (CBR); secondary end points included progression-free survival (PFS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",115.0,0.0669645,"Median PFS was 10.8 months (95% CI: 5.6-12.7) for combination therapy, and 6.5 months (95% CI: 5.4-8.5) for monotherapy [hazard ratio (HR) 0.69; 95% CI: 0.4-1.1, exploratory P-value = 0.12].","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Malorni', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy. Electronic address: luca.malorni@uslcentro.toscana.it.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Division of Early Drug Development, Department of Haematology and Haemato-Oncology, Istituto Europeo di Oncologia, University of Milan, Milan, Italy.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Minisini', 'Affiliation': 'Department of Oncology, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology Department, ASL Brindisi, Brindisi, Italy.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Tondini', 'Affiliation': 'Hospital Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': ""D'Hollander"", 'Affiliation': 'International Drug Development Institute, Louvain-La-Neuve, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Arpino', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bernardo', 'Affiliation': 'Medical Oncology Department, ICS Maugeri IRCCS, Pavia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martignetti', 'Affiliation': ""Oncology Department, Azienda USL Toscana Sud Est, Hospital Alta Val D'Elsa, Poggibonsi Siena, Italy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Criscitiello', 'Affiliation': 'Division of Early Drug Development, Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Puglisi', 'Affiliation': 'Medical Oncology and Cancer Prevention Unit, IRCCS, CRO National Cancer Institute, Aviano; Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pestrin', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sanna', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Moretti', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Risi', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Biagioni', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McCartney', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trial Coordinating Center, AOU Careggi, Istituto Toscano Tumori, Florence, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'International Drug Development Institute, San Francisco, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Migliaccio', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Biganzoli', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': '""Sandro Pitigliani"" Medical Oncology Department, Hospital of Prato, Prato, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy214']
437,32248846,Physiological responses to maximal eating in men.,"This study investigated metabolic, endocrine, appetite and mood responses to a maximal eating occasion in fourteen men (mean: age 28 (sd 5) years, body mass 77·2 (sd 6·6) kg and BMI 24·2 (sd 2·2) kg/m2) who completed two trials in a randomised crossover design. On each occasion, participants ate a homogenous mixed-macronutrient meal (pizza). On one occasion, they ate until 'comfortably full' (ad libitum) and on the other, until they 'could not eat another bite' (maximal). Mean energy intake was double in the maximal (13 024 (95 % CI 10 964, 15 084) kJ; 3113 (95 % CI 2620, 3605) kcal) compared with the ad libitum trial (6627 (95 % CI 5708, 7547) kJ; 1584 (95 % CI 1364, 1804) kcal). Serum insulin incremental AUC (iAUC) increased approximately 1·5-fold in the maximal compared with ad libitum trial (mean: ad libitum 43·8 (95 % CI 28·3, 59·3) nmol/l × 240 min and maximal 67·7 (95 % CI 47·0, 88·5) nmol/l × 240 min, P < 0·01), but glucose iAUC did not differ between trials (ad libitum 94·3 (95 % CI 30·3, 158·2) mmol/l × 240 min and maximal 126·5 (95 % CI 76·9, 176·0) mmol/l × 240 min, P = 0·19). TAG iAUC was approximately 1·5-fold greater in the maximal v. ad libitum trial (ad libitum 98·6 (95 % CI 69·9, 127·2) mmol/l × 240 min and maximal 146·4 (95 % CI 88·6, 204·1) mmol/l × 240 min, P < 0·01). Total glucagon-like peptide-1, glucose-dependent insulinotropic peptide and peptide tyrosine-tyrosine iAUC were greater in the maximal compared with ad libitum trial (P < 0·05). Total ghrelin concentrations decreased to a similar extent, but AUC was slightly lower in the maximal v. ad libitum trial (P = 0·02). There were marked differences on appetite and mood between trials, most notably maximal eating caused a prolonged increase in lethargy. Healthy men have the capacity to eat twice the energy content required to achieve comfortable fullness at a single meal. Postprandial glycaemia is well regulated following initial overeating, with elevated postprandial insulinaemia probably contributing.",2020,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","['Healthy men', 'fourteen men (mean ±SD: age 28 ±5 y, body mass 77.2 ±6.6 kg, body mass index 24.2 ±2.2 kg·m-2', 'men']",['homogenous mixed-macronutrient meal (pizza'],"['Postprandial glycaemia', 'comfortable fullness', 'lethargy', 'glucose', 'iAUC', 'Total GLP-1, GIP, and PYY iAUC', 'appetite and mood', 'TAG iAUC', 'Serum insulin iAUC', 'Total ghrelin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453577', 'cui_str': 'Pizza'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0966749,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Edinburgh', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Russell G', 'Initials': 'RG', 'LastName': 'Davies', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jariya', 'Initials': 'J', 'LastName': 'Buniam', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, LoughboroughLE11 3TU, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, BristolBS8 1TU, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001270']
438,31800306,N-Acetylcysteine for Pediatric Obsessive-Compulsive Disorder: A Small Pilot Study.,"Background:  Many children and adults with Obsessive-Compulsive Disorder (OCD) fail to respond to first-line pharmacological and behavioral treatments. Glutamate dysfunction may contribute to the development of OCD. N-acetylcysteine (NAC), a glutamate modulating drug, has shown to be a promising agent in adults with OCD.  Methods:  We conducted a double-blind, placebo-controlled clinical trial from July 2012 to January 2017. Children ages 8 to 17 years with OCD were assigned to receive NAC (up to 2700 mg/day) or the matching placebo for a period of 12 weeks. Children were required to be on stable psychiatric treatment (both medication and therapy) but were not required to be treatment-refractory. The primary outcome was OCD symptom severity as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We used linear mixed models to analyze the effect of NAC compared to placebo.  Results:  Due to poor recruitment and eventual expiration of the study medication, enrollment was stopped at 11 children out of a planned sample size of 40. Nonetheless, NAC was associated with significant reduction in CY-BOCS total score compared to placebo (Satterthwaite's test:  t  (37) = 2.36,  p  = 0.024) with effects separating from placebo beginning at week 8. Mean CY-BOCS total score decreased in the NAC group from 21.4 ± 4.65 at baseline to 14.4 ± 5.55 at week 12. In the placebo group, mean CY-BOCS total score remained unchanged (21.3 ± 4.65). In the NAC group, 1 out of 5 participants achieved >35% improvement in CY-BOCS total score, while none of the six patients in placebo group reached this improvement level. NAC and placebo were well tolerated. One mild adverse event was reported in each group.  Conclusions:  Our trial suggests that there may be some initial improvement in OCD symptom severity with NAC treatment. NAC was well tolerated in the study population. Future trials should employ multiple sites and have a larger study population to further confirm any benefits of NAC.",2020,"In the placebo group, mean CY-BOCS total score remained unchanged (21.3 ± 4.65).","['children and adults with Obsessive-Compulsive Disorder (OCD', 'Pediatric Obsessive-Compulsive Disorder', 'Children ages 8 to 17 years with OCD', 'July 2012 to January 2017', 'adults with OCD']","['matching placebo', 'NAC', 'placebo', 'NAC and placebo', 'N-Acetylcysteine', 'N-acetylcysteine (NAC']","['Mean CY-BOCS total score', 'tolerated', 'Results:  Due to poor recruitment and eventual expiration of the study medication', ""OCD symptom severity as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS"", 'mean CY-BOCS total score', 'OCD symptom severity', 'CY-BOCS total score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]",,0.314346,"In the placebo group, mean CY-BOCS total score remained unchanged (21.3 ± 4.65).","[{'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Child Study Center, Yale School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Maartje C', 'Initials': 'MC', 'LastName': 'Welling', 'Affiliation': 'Child Study Center, Yale School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Columbia University in the City of New York, Columbia School of Nursing, New York, New York.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Coughlin', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Mulqueen', 'Affiliation': 'Women and Infants Hospital, Providence, Rhode Island.'}, {'ForeName': 'Ewgeni', 'Initials': 'E', 'LastName': 'Jakubovski', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Coury', 'Affiliation': 'Department of Psychology, Yale College, New Haven, Connecticut.'}, {'ForeName': 'Angeli', 'Initials': 'A', 'LastName': 'Landeros-Weisenberger', 'Affiliation': 'Child Study Center, Yale School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bloch', 'Affiliation': 'Child Study Center, Yale School of Medicine, Yale University, New Haven, Connecticut.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0041']
439,32092160,Optimising epilepsy management with a smartphone application: a randomised controlled trial.,"OBJECTIVE


To assess whether a practical intervention based upon a smartphone application (app) would improve self-management and seizure control in adults with epilepsy.
DESIGN, SETTING


Randomised, controlled trial in western China, December 2017 to August 2018.
PARTICIPANTS


380 eligible people with epilepsy were recruited; 327 completed the 6-month follow-up (176 in the app group, 151 in the control group).
MAIN OUTCOME MEASURES


Self-management of epilepsy (measured with the validated Chinese Epilepsy Self-Management Scale, C-ESMS) and self-reported seizure frequency.
RESULTS


In the intention-to-treat analysis, the mean C-ESMS score increased significantly in the app group between baseline and the 6-month evaluation (from 121.7 [SD, 12.1] to 144.4 [SD, 10.0]; P < 0.001); improvements on the information management, medication management, and safety management subscales were also statistically significant. At 6 months, the mean overall C-ESMS score for the app group was significantly higher than that for the control group (125.4 [SD, 1.5];  P < 0.001). The proportion of patients who were seizure-free at the 6-month follow-up was larger for the app than the control group (54 of 190, 28% v 22 of 190, 12%), as was the proportion with reductions in frequency of between 75 and 100% (22 of 190, 12% v 8 of 190, 4%). Changes in C-ESMS score were not statistically associated with seizure frequency.
CONCLUSIONS


Using a smartphone app improved epilepsy self-management scores in people in western China. It should be further tested in larger populations in other areas. Our preliminary investigation of building digital communities for people with epilepsy should encourage similar approaches to managing other chronic diseases.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900026864, 24 October 2019.",2020,"In the intention-to-treat analysis, the mean C-ESMS score increased significantly in the app group between baseline and the 6-month evaluation (from 121.7 [SD, 12.1] to 144.4 [SD, 10.0]; P < 0.001); improvements on the information management, medication management, and safety management subscales were also statistically significant.","['people with epilepsy', 'adults with epilepsy', 'western China, December 2017 to August 2018', '24 October 2019', '380 eligible people with epilepsy were recruited; 327 completed the 6-month follow-up (176 in the app group, 151 in the control group', 'people in western China']","['smartphone', 'smartphone application', 'smartphone application (app']","['information management, medication management, and safety management subscales', 'epilepsy self-management scores', 'Self-management of epilepsy (measured with the validated Chinese Epilepsy Self-Management Scale, C-ESMS) and self-reported seizure frequency', 'mean overall C-ESMS score', 'mean C-ESMS score', 'Changes in C-ESMS score']","[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0012972', 'cui_str': 'Information Management'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0206216', 'cui_str': 'Safety Management'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.118807,"In the intention-to-treat analysis, the mean C-ESMS score increased significantly in the app group between baseline and the 6-month evaluation (from 121.7 [SD, 12.1] to 144.4 [SD, 10.0]; P < 0.001); improvements on the information management, medication management, and safety management subscales were also statistically significant.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Qiukui', 'Initials': 'Q', 'LastName': 'Hao', 'Affiliation': 'National Clinical Research Center for Geriatrics, Sichuan University West China Hospital, Chengdu, Sichuan, China.'}, {'ForeName': 'Qianning', 'Initials': 'Q', 'LastName': 'Mo', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Key Laboratory of Bio-Resource and Eco-Environment, College of Life Sciences, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}]",The Medical journal of Australia,['10.5694/mja2.50520']
440,31760524,The prognostic value of routine second transurethral resection in patients with newly diagnosed stage pT1 non-muscle-invasive bladder cancer: results from randomized 10-year extension trial.,"PURPOSE


To evaluate the impact of routine second TUR on the long-term outcome of patients with newly diagnosed stage pT1 non-muscle-invasive bladder cancer (NMIBC) MATERIAL AND METHODS: A total of 210 patients (mean age 62.1 years, 89.5% were males) with stage pT1 NMIBC who underwent first TUR were prospectively randomized into two groups including second TUR (n = 105) and no second TUR (n = 105) groups. Data on recurrence, disease progression, 7-year and 10-year recurrence-free survival (RFS), progression-free survival (PFS) and overall survival (OS) were recorded.
RESULTS


The median follow-up time was 119 months (IQR 65-168). Per-protocol (PP) analysis revealed that compared to patients without second TUR, patients with second TUR had significantly higher 5-year, 7-year and 10-year rates for RFS (59.4%, 57.9% and 54.8% vs. 36.3%, 31.7% and 26.8%, respectively, p < 0.001) and PFS (93.3%, 91.9% and 90.4% vs. 74.0%, 71.4% and 68.5%, respectively, p < 0.001). According to PP and intention-to-treat (ITT) analyses, the 10-year OS rate was significantly higher in patients with second TUR (59.1 vs. 40.8%, p = 0.004). Multivariate analysis revealed that undergoing second TUR (OR 1.661, 95% CI 1.156-2.385, p = 0.006) was an independent determinant of prolonged OS.
CONCLUSIONS


In conclusion, these findings indicate the prognostic value of second TUR in stage pT1 NMIBC patients, not only for RFS and PFS advantages but also for the long-term OS advantage. Therefore, second TUR should be routinely performed in all stage pT1 NMIBC patients with life expectancy of at least 10 years, given the positive contribution to all oncological outcomes.",2020,"Multivariate analysis revealed that undergoing second TUR (OR 1.661, 95% CI 1.156-2.385, p = 0.006) was an independent determinant of prolonged OS.
","['210 patients (mean age 62.1\xa0years, 89.5% were males) with stage pT1 NMIBC who underwent first TUR', 'patients with newly diagnosed stage pT1 non-muscle-invasive bladder cancer (NMIBC', 'patients with newly diagnosed stage pT1 non-muscle-invasive bladder cancer']","['routine second transurethral resection', 'routine second TUR']","['recurrence, disease progression, 7-year and 10-year recurrence-free survival (RFS), progression-free survival (PFS) and overall survival (OS', '5-year, 7-year and 10-year rates for RFS', '10-year OS rate', 'PFS']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",210.0,0.128442,"Multivariate analysis revealed that undergoing second TUR (OR 1.661, 95% CI 1.156-2.385, p = 0.006) was an independent determinant of prolonged OS.
","[{'ForeName': 'Askin', 'Initials': 'A', 'LastName': 'Eroglu', 'Affiliation': 'Baskent University Zubeyde Hanim Hospital, Izmir, Turkey. askineroglu@gmail.com.'}, {'ForeName': 'Rahmi Gokhan', 'Initials': 'RG', 'LastName': 'Ekin', 'Affiliation': 'Urla State Hospital, Izmir, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Koc', 'Affiliation': 'Tepecik Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Rauf Taner', 'Initials': 'RT', 'LastName': 'Divrik', 'Affiliation': 'Ege Sehir Hospital, Izmir, Turkey.'}]",International journal of clinical oncology,['10.1007/s10147-019-01581-0']
441,31823152,"A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study.","BACKGROUND


ERA 223 compared concurrent abiraterone acetate/prednisolone (AAP) plus radium-223 with AAP plus placebo in men with chemotherapy-naïve asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. We report data from a subgroup of Japanese patients in ERA 223.
METHODS


Patients were randomized to radium-223 (55 kBq/kg) or placebo once every 4 weeks (max. 6 cycles), and also received oral abiraterone acetate 1000 mg once daily plus prednisone/prednisolone 5 mg twice daily during and after radium-223/placebo treatment, until a symptomatic skeletal event (SSE). The primary endpoint was SSE-free survival (SSE-FS); overall survival (OS) was a secondary endpoint.
RESULTS


Of 806 patients randomized in ERA 223, 114 patients (57 per arm) were enrolled in Japan. SSE-FS was not improved significantly in the radium-223 arm [25.5 months, 95% CI 20.6-not estimated (NE)] compared with the placebo arm (28.7 months, 95% CI 19.7-NE) (HR = 0.907, 95% CI 0.501-1.642). OS and other secondary endpoints were not improved significantly in the radium-223 arm. The incidence of fracture was 23% and 11% in the radium-223 and placebo arms, respectively. The incidence of death was 32% and 36%, respectively.
CONCLUSIONS


In the Japanese ERA 223 subgroup, concurrent treatment with AAP and radium-223 did not significantly improve SSE-FS and increased the incidence of fracture, similar to outcomes achieved in the overall population, while an increased incidence of death was not evident. The combination of radium-223 with AAP is not recommended in Japanese patients with asymptomatic or mildly symptomatic mCRPC and bone metastases.
CLINICAL TRIAL REGISTRATION


Clinical trial registration no: NCT02043678.",2020,"In the Japanese ERA 223 subgroup, concurrent treatment with AAP and radium-223 did not significantly improve SSE-FS and increased the incidence of fracture, similar to outcomes achieved in the overall population, while an increased incidence of death was not evident.","['men with chemotherapy-naïve asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) and bone metastases', 'Japanese patients in the ERA 223 study', '114 patients (57 per arm) were enrolled in Japan', 'Japanese patients with asymptomatic or mildly symptomatic mCRPC and bone metastases', '806 patients randomized in ERA 223', 'Patients', 'subgroup of Japanese patients in ERA 223', 'castration-resistant metastatic prostate cancer']","['prednisone/prednisolone', 'radium-223', 'oral abiraterone acetate', 'placebo', 'abiraterone acetate and prednisolone', 'radium-223 with AAP', 'radium-223 and placebo', 'abiraterone acetate/prednisolone (AAP) plus radium-223 with AAP plus placebo']","['SSE-free survival (SSE-FS); overall survival (OS', 'incidence of fracture', 'SSE-FS', 'incidence of death']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0303282', 'cui_str': 'Radium-223'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0051989', 'cui_str': 'antiarrhythmic peptide'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",806.0,0.759276,"In the Japanese ERA 223 subgroup, concurrent treatment with AAP and radium-223 did not significantly improve SSE-FS and increased the incidence of fracture, similar to outcomes achieved in the overall population, while an increased incidence of death was not evident.","[{'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'Division of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. nmatsuba@east.ncc.go.jp.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Kimura', 'Affiliation': 'Department of Urology, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology and Renal Transplantation, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology, Kindai University Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan.'}, {'ForeName': 'Motonobu', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, 811-1395, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nagamori', 'Affiliation': 'Department of Urology, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4 Jo, Shiroishi-ku, Sapporo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mizokami', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, 13-1 Takaramachi, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kikukawa', 'Affiliation': 'Department of Urology, National Hospital Organization Kumamoto Medical Center, 1-5 Ninomaru, Chuo-ku, Kumamoto, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hosono', 'Affiliation': 'The Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Kinuya', 'Affiliation': 'The Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Krissel', 'Affiliation': 'Clinical Development, SBU Oncology, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siegel', 'Affiliation': 'Clinical Statistics, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kakehi', 'Affiliation': 'Kagawa University, Takamatsu, Kagawa, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-019-01589-6']
442,30010756,Adjuvant bevacizumab for melanoma patients at high risk of recurrence: survival analysis of the AVAST-M trial.,"Background


Bevacizumab is a recombinant humanised monoclonal antibody to vascular endothelial growth factor shown to improve survival in advanced solid cancers. We evaluated the role of adjuvant bevacizumab in melanoma patients at high risk of recurrence.
Patients and methods


Patients with resected AJCC stage IIB, IIC and III cutaneous melanoma were randomised to receive either adjuvant bevacizumab (7.5 mg/kg i.v. 3 weekly for 1 year) or standard observation. The primary end point was detection of an 8% difference in 5-year overall survival (OS) rate; secondary end points included disease-free interval (DFI) and distant metastasis-free interval (DMFI). Tumour and blood were analysed for prognostic and predictive markers.
Results


Patients (n=1343) recruited between 2007 and 2012 were predominantly stage III (73%), with median age 56 years (range 18-88 years). With 6.4-year median follow-up, 515 (38%) patients had died [254 (38%) bevacizumab; 261 (39%) observation]; 707 (53%) patients had disease recurrence [336 (50%) bevacizumab, 371 (55%) observation]. OS at 5 years was 64% for both groups [hazard ratio (HR) 0.98; 95% confidence interval (CI) 0.82-1.16, P = 0.78). At 5 years, 51% were disease free on bevacizumab versus 45% on observation (HR 0.85; 95% CI 0.74-0.99, P = 0.03), 58% were distant metastasis free on bevacizumab versus 54% on observation (HR 0.91; 95% CI 0.78-1.07, P = 0.25). Forty four percent of 682 melanomas assessed had a BRAFV600 mutation. In the observation arm, BRAF mutant patients had a trend towards poorer OS compared with BRAF wild-type patients (P = 0.06). BRAF mutation positivity trended towards better OS with bevacizumab (P = 0.21).
Conclusions


Adjuvant bevacizumab after resection of high-risk melanoma improves DFI, but not OS. BRAF mutation status may predict for poorer OS untreated and potential benefit from bevacizumab.
Clinical Trial Information


ISRCTN 81261306; EudraCT Number: 2006-005505-64.",2018,"OS at 5 years was 64% for both groups [hazard ratio (HR) 0.98; 95% confidence interval (CI) 0.82-1.16, P = 0.78).","['81261306; EudraCT Number: 2006-005505-64', 'Forty four percent of 682 melanomas assessed had a BRAFV600 mutation', 'Results\n\n\nPatients (n=1343) recruited between 2007 and 2012 were predominantly stage III (73%), with median age 56\u2009years (range 18-88\u2009years', 'melanoma patients at high risk of recurrence', 'Patients and methods\n\n\nPatients with resected AJCC stage IIB, IIC and III cutaneous melanoma']","['Adjuvant bevacizumab', 'adjuvant bevacizumab', 'bevacizumab', 'Bevacizumab']","['poorer OS', 'disease recurrence', '5-year overall survival (OS) rate; secondary end points included disease-free interval (DFI) and distant metastasis-free interval (DMFI', 'distant metastasis free', 'BRAF mutation positivity']","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",,0.751936,"OS at 5 years was 64% for both groups [hazard ratio (HR) 0.98; 95% confidence interval (CI) 0.82-1.16, P = 0.78).","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': 'Cambridge Cancer Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. Electronic address: pippa.corrie@addenbrookes.nhs.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Nathan', 'Affiliation': 'Medical Oncology, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': 'Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tahir', 'Affiliation': 'Oncology Research, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Faust', 'Affiliation': 'Oncology Department, Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Kelly', 'Affiliation': 'Sir Bobby Robson Cancer Trials Research Centre, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marples', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Danson', 'Affiliation': 'Weston Park Hospital, Academic Unit of Clinical Oncology, Sheffield, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': ""Cancer & Palliative Care, St. Helen's Hospital, St. Helens, UK.""}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Houston', 'Affiliation': 'Oncology Department, Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Board', 'Affiliation': 'Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Waterston', 'Affiliation': 'Clinical Trials Unit, Beatson WOS Cancer Centre, Glasgow, UK.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Nobes', 'Affiliation': 'Department of Clinical Oncology, Norfolk & Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Harries', 'Affiliation': ""Guy's & St. Thomas' Hospital, Guy's Cancer Centre, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Exeter Oncology Centre, Royal Devon and Exeter Hospital, Exeter, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dalgleish', 'Affiliation': ""St George's Hospital, Cancer Centre, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martin-Clavijo', 'Affiliation': 'Cancer Centre, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Westwell', 'Affiliation': 'Sussex Cancer Centre, Royal Sussex County Hospital, Brighton, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Casasola', 'Affiliation': 'Cancer Centre, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chao', 'Affiliation': 'Royal Free Hospital, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maraveyas', 'Affiliation': 'Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Patel', 'Affiliation': 'Academic Unit of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Ottensmeier', 'Affiliation': 'CRUK and NIHR Southampton Experimental Cancer Medicine Centre, Southampton University Hospitals NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': 'Oncology Centre, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Humphreys', 'Affiliation': 'Oncology Department, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Eccles', 'Affiliation': 'Oncology Department, Poole Hospital, Dorset, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Cambridge Cancer Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Barker', 'Affiliation': 'Cambridge Cancer Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Harman', 'Affiliation': 'Cambridge Cancer Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Cambridge Cancer Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Myers', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK; Experimental Cancer Medicine Centre, Oxford, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': 'Cambridge Cancer Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Rodwell', 'Affiliation': 'Melanoma Focus, Cambridge, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Oxford NIHR Biomedical Research Centre, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dziewulski', 'Affiliation': ''}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Holikova', 'Affiliation': ''}, {'ForeName': 'Udaiveer', 'Initials': 'U', 'LastName': 'Panwar', 'Affiliation': ''}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Tahir', 'Affiliation': ''}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Faust', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': ''}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Sirohi', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Middleton', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Marples', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': ''}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Mazhar', 'Initials': 'M', 'LastName': 'Ajaz', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Houston', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Board', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eaton', 'Affiliation': ''}, {'ForeName': 'Ashita', 'Initials': 'A', 'LastName': 'Waterston', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Nobes', 'Affiliation': ''}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Loo', 'Affiliation': ''}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stubbings', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harries', 'Affiliation': ''}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': ''}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Dalgleish', 'Affiliation': ''}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Martin-Clavijo', 'Affiliation': ''}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Westwell', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casasola', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chao', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Maraveyas', 'Affiliation': ''}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Poulam', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ottensmeier', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Humphreys', 'Affiliation': ''}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Eccles', 'Affiliation': ''}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Dega', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Herbert', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Brunt', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scott-Brown', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Richard Larry', 'Initials': 'RL', 'LastName': 'Hayward', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Woodings', 'Affiliation': ''}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Nayak', 'Affiliation': ''}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Burrows', 'Affiliation': ''}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wolstenholme', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': ''}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nicolson', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Barlow', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Scrase', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Podd', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gonzalez', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Highley', 'Affiliation': ''}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wolstenholme', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grumett', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': ''}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Talbot', 'Affiliation': ''}, {'ForeName': 'Kannon', 'Initials': 'K', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coltart', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Gee', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': ''}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Martin-Clavijo', 'Affiliation': ''}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': ''}, {'ForeName': 'Kannon', 'Initials': 'K', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coltart', 'Affiliation': ''}, {'ForeName': 'Kannon', 'Initials': 'K', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coltart', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy229']
443,32249668,Cognitively Challenging Agility Boot Camp Program for Freezing of Gait in Parkinson Disease.,"Introduction . It is well documented that freezing of gait (FoG) episodes occur in situations that are mentally challenging, such as dual tasks, consistent with less automatic control of gait in people with Parkinson disease (PD) and FoG. However, most physical rehabilitation does not include such challenges. The purpose was to determine (1) feasibility of a cognitively challenging Agility Boot Camp-Cognitive (ABC-C) program and (2) effects of this intervention on FoG, dual-task cost, balance, executive function, and functional connectivity.  Methods . A total of 46 people with PD and FoG enrolled in this randomized crossover trial. Each participant had 6 weeks of ABC-C and Education interventions. Outcome measures were the following: FoG, perceived and objective measures; dual-task cost on gait; balance; executive function; and right supplementary motor area (SMA)-pedunculopontine nucleus (PPN) functional connectivity. Effect sizes were calculated.  Results . ABC-C had high compliance (90%), with a 24% dropout rate. Improvements after exercise, revealed by moderate and large effect sizes, were observed for subject perception of FoG after exercise, dual-task cost on gait speed, balance, cognition (Scales for Outcomes in Parkinson's disease-Cognition), and SMA-PPN connectivity.  Conclusions . The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity. The study provided effect sizes to help design future studies with more participants and longer duration to fully determine the potential to improve FoG.",2020,"The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity.","['people with Parkinson disease (PD) and FoG', '46 people with PD and FoG enrolled']","['cognitively challenging Agility Boot Camp-Cognitive (ABC-C) program', 'Cognitively Challenging Agility Boot Camp Program']","['FoG, balance, dual-task cost, executive function, and brain connectivity', ""subject perception of FoG after exercise, dual-task cost on gait speed, balance, cognition (Scales for Outcomes in Parkinson's disease-Cognition), and SMA-PPN connectivity"", 'FoG, dual-task cost, balance, executive function, and functional connectivity', 'FoG, perceived and objective measures; dual-task cost on gait; balance; executive function; and right supplementary motor area (SMA)-pedunculopontine nucleus (PPN) functional connectivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450030', 'cui_str': 'Fog'}]","[{'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C1527386', 'cui_str': 'Peripheral line feeding'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0262306', 'cui_str': 'Nucleus Tegmentalis Pedunculopontinus'}]",46.0,0.0271566,"The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity.","[{'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'King', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Smulders', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Harker', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Lapidus', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Carlson-Kuhta', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Brett W', 'Initials': 'BW', 'LastName': 'Fling', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Peterson', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320909331']
444,31712987,Preventing acute kidney injury and improving outcome in critically ill patients utilizing risk prediction score (PRAIOC-RISKS) study. A prospective controlled trial of AKI prevention.,"BACKGROUND


Acute kidney injury (AKI) has significant impact on mortality and morbidity in critically ill patients.
METHODS


A prospective controlled interventional pilot study composed of observation and intervention arms was run at two different Intensive care unit (ICU) sites. A recently validated risk prediction score was used to predict the AKI in critically ill patients at high risk of developing AKI. All patients with established AKI at the time of recruitment were excluded from the study. A package of early preventive measures, including an early nephrology review was applied to high risk patients in the intervention arm to prevent AKI development.
RESULTS


We have recruited 108 patients at the intervention site and 98 patients at the observation site. The primary outcome measure was the AKI incidence. AKI incidence was significantly lower in the intervention arm than its incidence in the observation arm (11% vs 26%, p = 0.002). The median Time till recovery of AKI episodes was significantly lower in the intervention arm (3(1) vs. 5(2) days, p = 0.014) 0.30 day mortality was lower in the intervention arm, however, not statistically significant.
CONCLUSION


Our pilot study showed that it was feasible to apply a simple risk score to implement early preventive measures to high risk patients, consequently, mitigating the risk of AKI development and reducing the time till recovery of AKI episodes. Multicentre studies are needed to confirm this favourable effect.",2020,"AKI incidence was significantly lower in the intervention arm than its incidence in the observation arm (11% vs 26%, p = 0.002).","['All patients with established AKI at the time of recruitment were excluded from the study', 'critically ill patients at high risk of developing AKI', 'critically ill patients', 'critically ill patients utilizing risk prediction score (PRAIOC-RISKS) study', '108 patients at the intervention site and 98 patients at the observation site']",[],"['AKI incidence', 'median Time till recovery of AKI episodes', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",108.0,0.102574,"AKI incidence was significantly lower in the intervention arm than its incidence in the observation arm (11% vs 26%, p = 0.002).","[{'ForeName': 'Tarek Samy', 'Initials': 'TS', 'LastName': 'Abdelaziz', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt. taroukah5070@kasralainy.edu.eg.'}, {'ForeName': 'Ragai', 'Initials': 'R', 'LastName': 'Fouda', 'Affiliation': 'Medical ICU, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Wessam M', 'Initials': 'WM', 'LastName': 'Hussin', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Elyamny', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}]",Journal of nephrology,['10.1007/s40620-019-00671-6']
445,32087340,"The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.","INTRODUCTION


When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer.
METHODS AND DESIGN


OaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
DISCUSSION


The OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality.",2020,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","['patients undergoing LDCT screening', ""26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP"", '26 sites selected for participation in the OaSiS trial', 'for lung cancer']","['compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care', 'smoking cessation during CT screening']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],26.0,0.0444411,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","[{'ForeName': 'Kristie Long', 'Initials': 'KL', 'LastName': 'Foley', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America. Electronic address: kfoley@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Weaver', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Petty', 'Affiliation': 'Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bellinger', 'Affiliation': 'Pulmonology and Critical Care, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spangler', 'Affiliation': 'Family and Community Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stone', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dressler', 'Affiliation': 'Biostatistics and Data Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Lesser', 'Affiliation': 'Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chiles', 'Affiliation': 'Radiology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105963']
446,30137262,Analgesic Effects Evoked by Real and Imagined Acupuncture: A Neuroimaging Study.,"Acupuncture can provide therapeutic analgesic benefits but is limited by its cost and scheduling difficulties. Guided imagery is a commonly used method for treating many disorders, such as chronic pain. The present study examined a novel intervention for pain relief that integrates acupuncture with imagery called video-guided acupuncture imagery treatment (VGAIT). A total of 27 healthy subjects were recruited for a crossover-design study that included 5 sessions administered in a randomized order (i.e., baseline and 4 different interventions). We investigated changes in pain threshold and fMRI signals modulated by: 1) VGAIT, watching a video of acupuncture previously administered on the participant's own body at baseline while imagining it being concurrently applied; 2) a VGAIT control condition, watching a video of a cotton swab touching the skin; 3) real acupuncture; and 4) sham acupuncture. Results demonstrated that real acupuncture and VGAIT significantly increased pain threshold compared with respective control groups. Imaging showed that real acupuncture produced greater activation of the insula compared with VGAIT. VGAIT produced greater deactivation at the rostral anterior cingulate cortex. Our findings demonstrate that VGAIT holds potential clinical value for pain management.",2019,VGAIT produced greater deactivation at the rostral anterior cingulate cortex.,['27 healthy subjects'],"['Acupuncture', 'VGAIT', 'real acupuncture and VGAIT', 'acupuncture with imagery called video-guided acupuncture imagery treatment (VGAIT', 'Real and Imagined Acupuncture', 'VGAIT control condition, watching a video of a cotton swab touching the skin; 3) real acupuncture; and 4) sham acupuncture']","['pain threshold', 'pain relief']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",27.0,0.157563,VGAIT produced greater deactivation at the rostral anterior cingulate cortex.,"[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Gollub', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhy190']
447,32130661,Efficacy and Safety of Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin After Short-Term Intensive Insulin Therapy in Patients with Type 2 Diabetes Mellitus in China: Study Protocol for a Randomized Controlled Trial (BEYOND V).,"INTRODUCTION


Many Chinese patients who are uncontrolled by oral antidiabetic drugs (OADs) receive short-term intensive insulin therapy (IIT) in hospital to rapidly relieve glucose-associated toxicity and to preserve/improve β-cell function. However, evidence for optimizing insulin algorithms for maintenance treatment after IIT is lacking. This study will compare the efficacy and safety of basal insulin-based treatment versus twice-daily premixed insulin in type 2 diabetes mellitus (T2DM) patients after short-term in-hospital IIT.
METHODS


This 26-week randomized, multicenter, positive-controlled, open-label, parallel-group study will enroll approximately 400 male and female patients aged 18-70 years with poorly-controlled T2DM (HbA1c > 7.5%) despite treatment with metformin plus at least one other OAD for 8 or more weeks. During a run-in period of 7-10 days, patients will be treated in-hospital with IIT comprising insulin glargine (Lantus ® ) once daily and insulin glulisine (Apidra ® ) three times daily; both regimens will be titrated daily to achieve the glycemic goal. Eligible patients will then be randomized in a 1:1 ratio to insulin glargine plus OADs or twice-daily premixed insulin (NovoLog ®  Mix 70/30) for 24 weeks, with metformin maintained throughout the study in both treatment groups. The primary endpoint is HbA1c change from baseline to week 24. Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.
DISCUSSION


Given the current lack of clinical data, this study will provide evidence supporting safe and effective glycemic control using basal insulin glargine-based therapy plus OADs compared with twice-daily premixed insulin in Chinese patients with T2DM after short-term IIT. This will assist physicians by providing a wider choice of treatments.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03359837 (registered on 2 December 2017).",2020,"Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.
","['Chinese patients who are uncontrolled by oral antidiabetic drugs (OADs) receive', 'Patients with Type 2 Diabetes Mellitus in China', 'type 2 diabetes mellitus (T2DM) patients after short-term in-hospital IIT', 'Eligible patients', 'Chinese patients with T2DM after short-term IIT', '400 male and female patients aged 18-70\xa0years with poorly-controlled T2DM (HbA1c\u2009>\u20097.5%) despite treatment with metformin plus at least one other OAD for 8 or more weeks']","['short-term intensive insulin therapy (IIT', 'metformin', 'Short-Term Intensive Insulin Therapy', 'insulin glargine (Lantus ® ) once daily and insulin glulisine (Apidra ® ', 'basal insulin-based treatment versus twice-daily premixed insulin', 'Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin', 'insulin glargine plus OADs or twice-daily premixed insulin']","['assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction', 'Efficacy and Safety', 'efficacy and safety', 'HbA1c change']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0876064', 'cui_str': 'Lantus'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1313386', 'cui_str': 'insulin glulisine'}, {'cui': 'C1654827', 'cui_str': 'Apidra'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.149465,"Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Endocrinology Department, Gansu Provincial People's Hospital, Lanzhou, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Endocrinology Department, Tianjin First Center Hospital, Tianjin, China.'}, {'ForeName': 'Binhua', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Endocrinology Department, The First Hospital of Harbin, Harbin, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Endocrinology Department, The Second Affiliated Hospital of Baotou Medical University, Baotou, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Medical Affair Department, Sanofi Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Medical Affair Department, Sanofi Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'Jingcheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Medical Affair Department, Sanofi Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': 'Endocrinology Department, Chinese PLA General Hospital, Beijing, China. muyiming@301hospital.com.cn.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Endocrinology Department, Beijing Hospital, Beijing, China. glx1218@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01265-6']
448,31689482,"A nationwide randomized, double-blind, placebo-controlled physicians' trial of loxoprofen for the treatment of fatigue, headache, and nausea after hangovers.","Hangovers are associated with negative economic consequences due to decreased job performance or frequent visits to physicians. Thus, a new strategy for the alleviation of hangover-related symptoms is needed to avoid this detriment to society. The purpose of this nationwide randomized, double-blind, placebo-controlled physicians' trial was to evaluate the efficacy of loxoprofen sodium for the alleviation of fatigue, headache, and nausea after hangover. A total of 229 participants were randomized to receive loxoprofen sodium (60 mg once orally) or placebo. The study was closed when the first 150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers. The primary endpoint was set as the difference in severity of general fatigue before and 3 h after taking the test drugs and was evaluated using a visual analogue scale. Secondary endpoints included difference in severity of headache, nausea, and incidence of adverse events. The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men, and both groups were comparable for baseline characteristics. The alleviation of general fatigue did not differ statistically between the loxoprofen and placebo groups (24 [14-49] vs. 19 [9-35], p = 0.07). However, the alleviation of headache was statistically greater in the loxoprofen group (25 [10-50] vs. 10 [2-30], adjusted difference 14, 95% confidence interval 8-21, p < 0.001), whereas, there was no difference in nausea (7 [0-27] vs. 10 [0-24], p = 0.68). The incidence of adverse symptoms such as epigastric discomfort was also comparable between groups (2.7% vs. 3.9%, p = 0.25). Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea.",2020,Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea.,"['150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers', 'The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men', '229 participants']","['Placebo', 'loxoprofen', 'loxoprofen sodium', 'placebo', 'Loxoprofen', 'Loxoprofen sodium']","['Fatigue, Headache, and Nausea', 'incidence of adverse symptoms such as epigastric discomfort', 'general fatigue or nausea', 'severity of headache, nausea, and incidence of adverse events', 'alleviation of general fatigue', 'alleviation of headache', 'severity of general fatigue', 'nausea', 'relieving headaches', 'alleviation of fatigue, headache, and nausea', 'visual analogue scale']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0065199', 'cui_str': 'loxoprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0393756', 'cui_str': 'Hangover (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065199', 'cui_str': 'loxoprofen'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1291078', 'cui_str': 'Epigastric discomfort (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",229.0,0.49438,Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea.,"[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Hara', 'Affiliation': 'Department of Clinical Investigation, Japan Society of Clinical Research, 1-11-1000 Umeda, Kita-ku, Osaka, 530-0001, Japan; Center for Community-based Healthcare Research and Education, Shimane University Graduate School of Medicine, 89-1 Enyacho, Izumo, 693-8501, Japan. Electronic address: hara@japanscr.org.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Faculty of Science and Technology, Department of Mathematics, Keio University, 3-14-1 Hiyoshi, Kohoku-ku, Yokohama, 223-8522, Japan. Electronic address: hayashi@math.keio.ac.jp.'}, {'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Division of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, 565-0871, Japan. Electronic address: lucky_unatan@yahoo.co.jp.'}, {'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Honda', 'Affiliation': 'Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University, 1 Hikariga-oka, Fukushima, 960-1295, Japan. Electronic address: m-honda@fmu.ac.jp.'}, {'ForeName': 'Masatake', 'Initials': 'M', 'LastName': 'Tamaki', 'Affiliation': 'Department of Clinical Investigation, Japan Society of Clinical Research, 1-11-1000 Umeda, Kita-ku, Osaka, 530-0001, Japan; Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University, 1 Hikariga-oka, Fukushima, 960-1295, Japan. Electronic address: tamaki@japanscr.org.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2019.10.006']
449,32246167,Impact of denosumab on cardiovascular calcification in patients with secondary hyperparathyroidism undergoing dialysis: a pilot study.,"The receptor activator of nuclear factor-kappa B ligand (RANKL)/RANK/osteoprotegerin system is dysregulated in hyperparathyroid bone diseases. The introduction of denosumab preceding elective surgery as an alternative option when surgery is not possible immediately.
INTRODUCTION


The effects of denosumab on vascular calcification in patients with chronic renal failure and low bone mass have been a subject of interest. Therefore, this investigation aimed to determine the short-term changes in vascular calcification after denosumab treatment using a serial electrocardiography-gated computed tomography (CT) to measure coronary artery calcification (CAC) in patients with secondary hyperparathyroidism (SHPT) and low bone mass.
METHODS


This 6-month study enrolled patients with SHPT and low bone mass (T-score < - 2.5) owing to dialysis. The 2 groups administered denosumab at a dose of 60 mg (denosumab group), and conventional treatment (control group) had 21 patients each. All patients underwent CT scans at baseline and at the follow-up examination at 6 months to determine the bone mineral density and CAC.
RESULTS


The control group demonstrated a significant increase in Agatston scores (187.79 ± 72.27) (P = 0.004). However, no significant change was noted in the denosumab group (P = 0.41). In the denosumab group, only the baseline serum alkaline phosphatase levels correlated negatively with changes in the CAC score (P = 0.01); the baseline alkaline phosphatase levels were the deciding biomarkers for non-responsive CAC scores by Berry Criteria after denosumab treatment (P = 0.02). The denosumab group demonstrated significantly increased bone mineral density in the femoral neck and lumbar spine (P < 0.01).
CONCLUSION


The findings provide evidence that denosumab may suppress the progression of CAC and also regress osseous calcification in severe cases of high bone turnover.",2020,"The denosumab group demonstrated significantly increased bone mineral density in the femoral neck and lumbar spine (P < 0.01).
","['enrolled patients with SHPT and low bone mass (T-score\u2009<\u2009-\u20092.5) owing to dialysis', 'patients with secondary hyperparathyroidism (SHPT) and low bone mass', 'patients with secondary hyperparathyroidism undergoing dialysis', 'patients with chronic renal failure and low bone mass']","['denosumab', 'serial electrocardiography-gated computed tomography (CT']","['femoral neck and lumbar spine', 'Agatston scores', 'vascular calcification', 'bone mineral density', 'baseline alkaline phosphatase levels', 'CAC score', 'cardiovascular calcification', 'baseline serum alkaline phosphatase levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428332', 'cui_str': 'Alkaline phosphatase level - finding'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}]",,0.0349687,"The denosumab group demonstrated significantly increased bone mineral density in the femoral neck and lumbar spine (P < 0.01).
","[{'ForeName': 'C-L', 'Initials': 'CL', 'LastName': 'Chen', 'Affiliation': 'Division of Nephrology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'N-C', 'Initials': 'NC', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'F-Z', 'Initials': 'FZ', 'LastName': 'Wu', 'Affiliation': 'Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'M-T', 'Initials': 'MT', 'LastName': 'Wu', 'Affiliation': 'Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan. wu.mingting@gmail.com.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05391-3']
450,32179258,Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial.,"BACKGROUND


Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease.
METHODS


Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
CONCLUSIONS


The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.",2020,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","['Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter', 'Approximately 3,830 patients', 'coronary artery disease patients', 'patients with coronary artery disease']","['Quantitative flow ratio-guided strategy versus angiography-guided strategy', 'angiography-guided strategy will undergo PCI based on angiography', 'QFR-guided versus an angiography-guided PCI strategy', 'QFR-guided or an angiography-guided strategy', 'Quantitative flow ratio (QFR', 'percutaneous coronary intervention (PCI', 'QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy']","['efficacy and cost-effectiveness', 'individual components of MACE and cost-effectiveness end points', '1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization', '1-year MACE excluding periprocedural myocardial infarction']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}]",3830.0,0.0747895,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Daixin', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: qsbfw@sina.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: bxu@citmd.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.015']
451,30753303,Rehabilitation After Hip Fracture for Nursing Home Residents: A Controlled Feasibility Trial.,"BACKGROUND


This study compared functional outcomes at 3 months after hip fracture surgery between nursing home residents participating in a 10-week outreach rehabilitation program and those receiving usual care. Function, health-related quality of life, and mortality were also compared over 12 months, and outreach program feasibility was assessed.
METHODS


A feasibility trial was undertaken in Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition. Outreach participants received 10 weeks of rehabilitation (30 sessions), and Control participants received usual posthospital fracture care in their nursing homes. The primary outcome was the Functional Independence Measure Physical Domain (FIMphysical) score 3 months post-fracture; we also explored FIM Locomotion and Mobility. Secondary outcomes were FIM scores, EQ-5D-3L scores, and mortality over 12 months. Program feasibility was also evaluated.
RESULTS


The mean age was 88.7 ± 7.0 years, 55 (71%) were female, and 58 (75%) had severe cognitive impairment with no significant group differences (p > .14). Outreach participants had significantly higher FIM Locomotion than usual care (p = .02), but no significant group differences were seen in FIMphysical or FIM Mobility score 3 months post-fracture. In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared with Control participants over 12 months (p < .05). Mortality did not differ by group (p = .80). Thirty (65%) Outreach participants completed the program.
CONCLUSIONS


Our feasibility trial demonstrated that Outreach participants achieved better locomotion by 3 months post-fracture compared with participants receiving usual postfracture care; benefits were sustained to 12 months post-fracture. In adjusted analyses, Outreach participants also showed sustained benefits in physical function and health-related quality of life.",2019,"In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared to Control participants over 12-months(p<0.05).","['Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition', 'Nursing Home Residents', 'hip fracture surgery between nursing home residents participating in a 10-week']","['outreach rehabilitation program and those receiving usual care', 'rehabilitation (30 sessions) and Control participants received usual post-hospital fracture care in their nursing homes']","['Mortality', 'Function, health-related quality of life (HRQL) and mortality', 'FIM scores, EQ-5D-3L scores and mortality over 12-months', 'FIM Locomotion and Mobility', 'better locomotion', 'FIM Locomotion', 'FIM and EQ-5D-3L scores', 'physical function and HRQL', 'severe cognitive impairment', 'Functional Independence Measure Physical Domain(FIMphysical) score', 'FIMphysical or FIM Mobility score']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1160964', 'cui_str': 'Fracture care'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",77.0,0.0812392,"In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared to Control participants over 12-months(p<0.05).","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Magaziner', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'C Allyson', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Gian S', 'Initials': 'GS', 'LastName': 'Jhangri', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'D William C', 'Initials': 'DWC', 'LastName': 'Johnston', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz031']
452,32238534,Mindfulness-Based Stress Reduction for Parents Implementing Early Intervention for Autism: An RCT.,"BACKGROUND AND OBJECTIVES


Systems of care emphasize parent-delivered intervention for children with autism spectrum disorder (ASD). Meanwhile, multiple studies document psychological distress within these parents. This pilot longitudinal randomized controlled trial compared the parent-implemented Early Start Denver Model (P-ESDM) to P-ESDM plus mindfulness-based stress reduction (MBSR) for parents. We evaluated changes in parent functioning during active treatment and at follow-up.
METHODS


Participants included children (<36 months old) with autism spectrum disorder and caregivers. Participants were randomly assigned to P-ESDM only ( n  = 31) or P-ESDM plus MBSR ( n  = 30). Data were collected at baseline, midtreatment, the end of treatment, and 1, 3, and 6 months posttreatment. Multilevel models with discontinuous slopes were used to test for group differences in outcome changes over time.
RESULTS


Both groups improved during active treatment in all subdomains of parent stress (β = -1.42, -1.25, -0.92;  P  < 0.001), depressive symptoms, and anxiety symptoms (β = -0.62 and -0.78, respectively;  P  < 0.05). Parents who received MBSR had greater improvements than those receiving P-ESDM only in parental distress and parent-child dysfunctional interactions (β = -1.91 and -1.38, respectively;  P  < 0.01). Groups differed in change in mindfulness during treatment (β = 3.15;  P  < .05), with P-ESDM plus MBSR increasing and P-ESDM declining. Treatment group did not significantly predict change in depressive symptoms, anxiety symptoms, or life satisfaction. Differences emerged on the basis of parent sex, child age, and child behavior problems.
CONCLUSIONS


Results suggest that manualized, low-intensity stress-reduction strategies may have long-term impacts on parent stress. Limitations and future directions are described.",2020,"Parents who received MBSR had greater improvements than those receiving P-ESDM only in parental distress and parent-child dysfunctional interactions (β = -1.91 and -1.38, respectively;  P  < 0.01).","['Participants included children (<36 months old) with autism spectrum disorder and caregivers', 'parents', 'Parents Implementing Early Intervention for Autism', 'children with autism spectrum disorder (ASD']","['parent-implemented Early Start Denver Model (P-ESDM) to P-ESDM plus mindfulness-based stress reduction (MBSR', 'MBSR', 'Mindfulness-Based Stress Reduction', 'P-ESDM', 'P-ESDM plus MBSR']","['parental distress and parent-child dysfunctional interactions', 'depressive symptoms, anxiety symptoms, or life satisfaction', 'depressive symptoms, and anxiety symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.070461,"Parents who received MBSR had greater improvements than those receiving P-ESDM only in parental distress and parent-child dysfunctional interactions (β = -1.91 and -1.38, respectively;  P  < 0.01).","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Weitlauf', 'Affiliation': 'Departments of Pediatrics and amy.s.weitlauf@vumc.org.'}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Broderick', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'J Alacia', 'Initials': 'JA', 'LastName': 'Stainbrook', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Julie Lounds', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Herrington', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Nicholson', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Santulli', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Dykens', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'A Pablo', 'Initials': 'AP', 'LastName': 'Juárez', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Zachary E', 'Initials': 'ZE', 'LastName': 'Warren', 'Affiliation': 'Departments of Pediatrics and.'}]",Pediatrics,['10.1542/peds.2019-1895K']
453,31431654,Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.,"OBJECTIVE


Extremely low birth weight children are at high risk for cognitive impairment.
STUDY DESIGN


Cognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.
RESULT


Higher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.
CONCLUSION


Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.",2019,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"['extremely low birth weight infants', 'extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed', 'extremely low birth weight children']",[],"['Cognitive outcome', 'Higher Family Resource Scale scores', 'cognitive scores']","[{'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0599714,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Fuller', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA. mfuller@sandiego.edu.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Vaucher', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Women, and Infants Hospital, Brown University, Providence, RI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0462-2']
454,31157964,Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer.,"BACKGROUND


Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer.
METHODS


In this open-label, randomized, phase 3 trial, we assigned patients to receive testosterone suppression plus either open-label enzalutamide or a standard nonsteroidal antiandrogen therapy (standard-care group). The primary end point was overall survival. Secondary end points included progression-free survival as determined by the prostate-specific antigen (PSA) level, clinical progression-free survival, and adverse events.
RESULTS


A total of 1125 men underwent randomization; the median follow-up was 34 months. There were 102 deaths in the enzalutamide group and 143 deaths in the standard-care group (hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.86; P = 0.002). Kaplan-Meier estimates of overall survival at 3 years were 80% (based on 94 events) in the enzalutamide group and 72% (based on 130 events) in the standard-care group. Better results with enzalutamide were also seen in PSA progression-free survival (174 and 333 events, respectively; hazard ratio, 0.39; P<0.001) and in clinical progression-free survival (167 and 320 events, respectively; hazard ratio, 0.40; P<0.001). Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively). Fatigue was more common in the enzalutamide group; seizures occurred in 7 patients in the enzalutamide group (1%) and in no patients in the standard-care group.
CONCLUSIONS


Enzalutamide was associated with significantly longer progression-free and overall survival than standard care in men with metastatic, hormone-sensitive prostate cancer receiving testosterone suppression. The enzalutamide group had a higher incidence of seizures and other toxic effects, especially among those treated with early docetaxel. (Funded by Astellas Scientific and Medical Affairs and others; ENZAMET (ANZUP 1304) ANZCTR number, ACTRN12614000110684; ClinicalTrials.gov number, NCT02446405; and EU Clinical Trials Register number, 2014-003190-42.).",2019,"Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively).","['men with castration-resistant prostate cancer', 'Metastatic Prostate Cancer', 'men with metastatic, hormone-sensitive prostate cancer receiving testosterone suppression', 'men with metastatic, hormone-sensitive prostate cancer', 'A total of 1125 men']","['enzalutamide', 'Enzalutamide with Standard First-Line Therapy', 'testosterone suppression plus either open-label enzalutamide or a standard nonsteroidal antiandrogen therapy (standard-care group', 'docetaxel']","['seizures and other toxic effects', 'progression-free survival as determined by the prostate-specific antigen (PSA) level, clinical progression-free survival, and adverse events', 'adverse events', 'seizures', 'PSA progression-free survival', 'progression-free and overall survival', 'Fatigue', 'overall survival', 'clinical progression-free survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1320169', 'cui_str': 'AntiAndrogens, Nonsteroidal'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",1125.0,0.118426,"Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively).","[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Martin', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Begbie', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Xanthi', 'Initials': 'X', 'LastName': 'Coskinas', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Wendy E', 'Initials': 'WE', 'LastName': 'Hague', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Horvath', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Lawrence', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCaffrey', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'McDermott', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McJannett', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'North', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Parulekar', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Pook', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'M Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Shahneen K', 'Initials': 'SK', 'LastName': 'Sandhu', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'T Hsiang', 'Initials': 'TH', 'LastName': 'Tan', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Thomson', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Tu', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Vera-Badillo', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Yip', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Alison Y', 'Initials': 'AY', 'LastName': 'Zhang', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Zielinski', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1903835']
455,32248405,Concentration of NK cells after β-glucan and vitamin D supplementation in patients with diabetic retinopathy.,"In our study, we focused on possible effects of supplementation with glucan and vitamin D on total numbers of NK cells in patients with diabetic retinopathy. We evaluated possible relations among nutritional state (BMI), leptin levels, and total numbers of NK cells in patients supplemented with (1) glucan and vitamin D, (2) vitamin D and placebo, and (3) vitamin D alone. Our results show that 3 months of supplementation with both glucan and vitamin D resulted in significant improvements of NK cell numbers. In addition, we found statistically significant correlation between NK cell numbers and leptin levels. Based on these results, we propose that the molecule responsible for these changes is glucan, as vitamin D alone or together with placebo caused no effects.",2020,Our results show that 3 months of supplementation with both glucan and vitamin D resulted in significant improvements of NK cell numbers.,"['patients supplemented with (1', 'patients with diabetic retinopathy']","['placebo', 'glucan and vitamin D, (2) vitamin D and placebo, and (3) vitamin D alone', 'vitamin D', 'β-glucan and vitamin D supplementation', 'supplementation with glucan and vitamin D']","['nutritional state (BMI), leptin levels, and total numbers of NK cells', 'NK cell numbers and leptin levels', 'NK cell numbers', 'Concentration of NK cells', 'total numbers of NK cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.113824,Our results show that 3 months of supplementation with both glucan and vitamin D resulted in significant improvements of NK cell numbers.,"[{'ForeName': 'Richter', 'Initials': 'R', 'LastName': 'Josef', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Pohorska', 'Initials': 'P', 'LastName': 'Jitka', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Závorková', 'Initials': 'Z', 'LastName': 'Martina', 'Affiliation': 'Oční klinika UJEP Masarykova nemocnice, Krajská zdravotní, a.s., Usti nad Labem, Czech Republic.'}, {'ForeName': 'Král', 'Initials': 'K', 'LastName': 'Vlastimil', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Stiborova', 'Initials': 'S', 'LastName': 'Ivana', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Dobiasova Rajnohova', 'Initials': 'DR', 'LastName': 'Lucie', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Vetvicka', 'Initials': 'V', 'LastName': 'Vaclav', 'Affiliation': 'Department of Pathology, University of Louisville, 511 S. Floyd St., Louisville, KY, 40202, USA. Vaclav.vetvicka@louisville.edu.'}]",Folia microbiologica,['10.1007/s12223-020-00789-2']
456,32250132,A randomized study on the efficacy of the Social Cognition Training Program-brief version in a sample of patients with schizophrenia.,"OBJECTIVE


In recent years, various interventions have been developed to train social cognition in schizophrenia, which have been shown to be effective in improving emotional processing, theory of mind and social perception, as well as community functioning. One of these interventions is the Social Cognition Training Program (SCTP), a program consisting of 24 sessions. For the present study we developed a brief version of 12 sessions with the aim to improve its applicability. To evaluate the effectiveness of this version, a randomized controlled trial was conducted comparing the SCTP to a neurocognitive training.
METHOD


The trial was conducted with a sample of 299 patients with schizophrenia, with assessments conducted at baseline, posttreatment, and 6- and 12-month follow up. The assessment protocol included tests of emotion recognition, theory of mind, attributional style, symptomatology, community functioning, and neurocognitive functioning.
RESULTS


The results obtained showed that the patients of the experimental group improved in the recognition of the emotions of sadness, anger, and fear, and in the first- and second-order theory of mind. However, no significant improvement was observed in the measures of community functioning. Improvements in first- and second-order theory of mind but not emotion recognition persisted at follow ups.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


Results obtained showed that deficits in social cognition can be ameliorated, although it could be necessary to have booster sessions to maintain the benefits of the training and to complement the SCPT with another type of interventions aimed specifically at transferring the benefits of social cognition training to ""real"" life. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The results obtained showed that the patients of the experimental group improved in the recognition of the emotions of sadness, anger, and fear, and in the first- and second-order theory of mind.","['299 patients with schizophrenia, with assessments conducted at baseline, posttreatment, and 6- and 12-month follow up', 'patients with schizophrenia']","['SCTP', 'Social Cognition Training Program (SCTP', 'Social Cognition Training Program-brief version']","['emotion recognition, theory of mind, attributional style, symptomatology, community functioning, and neurocognitive functioning', 'community functioning', 'recognition of the emotions of sadness, anger, and fear']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",299.0,0.0168544,"The results obtained showed that the patients of the experimental group improved in the recognition of the emotions of sadness, anger, and fear, and in the first- and second-order theory of mind.","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Fernández-Modamio', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gil-Sanz', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Arrieta-Rodríguez', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Iciar', 'Initials': 'I', 'LastName': 'Santacoloma-Cabero', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Bengochea-Seco', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'González-Fraile', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Muñiz', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychiatric rehabilitation journal,['10.1037/prj0000410']
457,32246655,Clinical evaluation of bulk-fill resins and glass ionomer restorative materials: A 1-year follow-up randomized clinical trial in children.,"Objective


This prospective study aimed to evaluate the clinical performance of different restorative materials in primary molars with class II carious lesions.
Materials and Methods


A total of 160 class II carious lesions (with radiographic involvement of the outer half of dentin) in 30 patients were randomly divided into four groups and restored with a glass ionomer restorative system (Equia™), two different bulk-fill composites (Sonicfill™ and X-tra fil™), and a nanohybrid composite (Filtek Z550™). The restorations were clinically and radiographically evaluated at the baseline, and 3, 6, and 12 months according to the modified United States Public Health Service criteria. Statistical analyses were performed using Pearson's Chi-square and McNemar tests.
Results


After 1 year, 134 restorations were evaluated in 26 patients. Equia was statistically less successful than the other restorative materials in marginal adaptation and retention criteria (P < 0.05). However, no material was found to be superior to the others over the study period in marginal discoloration, color matching, secondary caries, anatomical form, and postoperative sensitivity (P > 0.05).
Conclusion


The bulk-fill and conventional composites exhibited good clinical performance, and Equia exhibited minor changes over the 1-year trial period.",2020,"However, no material was found to be superior to the others over the study period in marginal discoloration, color matching, secondary caries, anatomical form, and postoperative sensitivity (P > 0.05).
","['134 restorations were evaluated in 26 patients', '160 class II carious lesions (with radiographic involvement of the outer half of dentin) in 30 patients', 'children', 'primary molars with class II carious lesions']","['glass ionomer restorative system (Equia™), two different bulk-fill composites (Sonicfill™ and X-tra fil™), and a nanohybrid composite (Filtek Z550™', 'bulk-fill resins and glass ionomer restorative materials']","['marginal discoloration, color matching, secondary caries, anatomical form, and postoperative sensitivity']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4310016', 'cui_str': 'SonicFill'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4085648', 'cui_str': 'Tagalog language'}, {'cui': 'C4309980', 'cui_str': 'Filtek Z550'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",30.0,0.0227367,"However, no material was found to be superior to the others over the study period in marginal discoloration, color matching, secondary caries, anatomical form, and postoperative sensitivity (P > 0.05).
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Akman', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Alanya Alaaddin Keykubat University, Antalya, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tosun', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Selçuk University, Konya, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_519_19']
458,32135337,Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects.,"BACKGROUND


Studies assessing the impact of sleep restriction (SR) on blood pressure (BP) are limited by short study length, extreme SR (<4 hours a night), and lack of attention to psychological distress as a possible mediator.
METHODS


A community-based cohort was assembled with 237 women (age 34.1 ± 13.5 years; body mass index 25.4 ± 5.4 kg/m 2 ), and a randomized, crossover, intervention study was conducted in 41 women (24 completed: age 30.2 ± 6.5 years; body mass index 24.3 ± 2.8 kg/m 2 ) to determine the causal effect of SR on BP. Sleep was maintained as usual (HS) or reduced by 1.5 hours a night (SR) for 6 weeks. In the cohort, associations between sleep and psychosocial factors were evaluated using multivariable models adjusted for demographic and clinical confounders. In the intervention study, in-office BP was measured weekly; ambulatory BP was measured at end point. Psychological factors were assessed at baseline and end point. Mixed-model analyses with total sleep time (TST, main predictor), week and fraction of time spent in physical activity (covariates), and subject (random effect) were performed.
RESULTS


Among the community cohort, higher perceived stress, stressful events and distress, and lower resilience were associated with shorter sleep, worse sleep quality, and greater insomnia symptoms (P < .05). In the intervention, systolic BP increased as TST decreased (TST × week interaction, [coefficient ± standard error] -0.0097 ± 0.0046, P = .036). Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS. Psychological distress variables were not affected by TST and did not mediate the effects of SR on BP.
CONCLUSIONS


These results suggest that SR influences CVD risk in women via mechanisms independent of psychological stressors.",2020,"Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS.","['41 women (24 completed: age 30.2\u202f±\u202f6.5 years; body mass index 24.3\u202f±\u202f2.8 kg/m 2 ', 'premenopausal women with no indication of mediation by psychological effects', 'A community-based cohort was assembled with 237 women (age 34.1\u202f±\u202f13.5 years; body mass index 25.4\u202f±\u202f5.4 kg/m 2 ']","['Mild sleep restriction', 'sleep restriction (SR']","['mean arterial pressure', 'total sleep time (TST, main predictor), week and fraction of time spent in physical activity (covariates), and subject (random effect', '24-hour ambulatory blood pressure', 'shorter sleep, worse sleep quality, and greater insomnia symptoms', 'Psychological factors', 'blood pressure (BP', 'Wake ambulatory diastolic blood pressure', 'stress, stressful events and distress', 'ambulatory BP', 'Sleep', 'Psychological distress variables', 'systolic BP increased as TST']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521090', 'cui_str': 'No indication of (contextual qualifier) (qualifier value)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",237.0,0.0291203,"Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS.","[{'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'St-Onge', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY; Institute of Human Nutrition, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, NY. Electronic address: ms2554@cumc.columbia.edu.'}, {'ForeName': 'Ayanna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Aggarwal', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Jasmine L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Institute of Human Nutrition, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, NY; Tulane Medical Center, New Orleans, LA.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Spruill', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'RoyChoudhury', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.02.006']
459,31915883,[Study protocol of the monocentric prospective randomized placebo-controlled double-blind phase II study to explore the protective effects of the ginkgo biloba extract EGb 761® from temporary noise-induced hearing loss].,"BACKGROUND


Hearing loss is frequently induced by occupational noise exposure and leads to rising hearing thresholds as well as reduced otoacoustic emissions (OAE), mostly caused by metabolic hair cell decompensation.
OBJECTIVE


Primary endpoint is the increase in average pure tone thresholds after noise exposure, secondary endpoints are loss of distortion product and click-evoked OAE as well as reduction of their contralateral suppression.
PARTICIPANTS AND METHODS


The present study design describes the verification of the anti-oxidant and neuroprotective properties of EGb 761® by evaluation of cochlear protection from noise impact as well as its safety and tolerance in 202 healthy male participants distributed equally to verum and placebo groups in a double-blind manner. Participants were assessed, medicated, exposed to noise, and then examined at timepoints up to 10 min and 4 weeks thereafter.
CONCLUSION


This summary of the verification study protocol highlights the complexity of diligent and precise planning according to the European Medicines Agency criteria for controlled trials (EudraCT). Key points are the intervention rationale, definitions of in- and exclusion criteria, estimation of subject numbers, and examination method setting in terms of optimum endpoint description.",2020,This summary of the verification study protocol highlights the complexity of diligent and precise planning according to the European Medicines Agency criteria for controlled trials (EudraCT).,['202 healthy male participants distributed equally to verum and placebo groups in a double-blind manner'],"['placebo', 'ginkgo biloba extract EGb']","['temporary noise-induced hearing loss', 'loss of distortion product and click-evoked OAE']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0018781', 'cui_str': 'Noise-induced hearing loss (disorder)'}, {'cui': 'C0332482', 'cui_str': 'Abnormal shape'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]",761.0,0.132303,This summary of the verification study protocol highlights the complexity of diligent and precise planning according to the European Medicines Agency criteria for controlled trials (EudraCT).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mühlmeier', 'Affiliation': 'Klinik und Poliklinik für HNO-Heilkunde, Kopf- und Halschirurgie, Bundeswehrkrankenhaus Ulm, Oberer Eselsberg\xa040, 89081, Ulm, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schweikert', 'Affiliation': 'Klinik für HNO-Heilkunde, Bundeswehrkrankenhaus Berlin, Berlin, Deutschland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schramm', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin, Bundeswehrkrankenhaus Berlin, Berlin, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Burkart', 'Affiliation': 'Medical Affairs, Dr. Willmar Schwabe GmbH & Co. KG, Ettlingen, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tisch', 'Affiliation': 'Klinik und Poliklinik für HNO-Heilkunde, Kopf- und Halschirurgie, Bundeswehrkrankenhaus Ulm, Oberer Eselsberg\xa040, 89081, Ulm, Deutschland. matthias.tisch@hals-nasen-ohren.net.'}]",HNO,['10.1007/s00106-019-00807-x']
460,32217365,PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure: Results of the PRIME-HF Trial.,"BACKGROUND


Ivabradine is guideline-recommended to reduce heart failure (HF) hospitalization in patients with stable chronic HF with reduced ejection fraction (EF). Ivabradine initiation following acute HF has had limited evaluation, and there are few randomized data in US patients. The PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure (PRIME-HF) study was conducted to address predischarge ivabradine initiation in stabilized acute HF patients.
METHODS


PRIME-HF was an investigator-initiated, randomized, open-label study of predischarge initiation of ivabradine versus usual care. Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min. Ivabradine was acquired per routine care. The primary end point was the proportion of patients on ivabradine at 180 days. Additional end points included heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension).
RESULTS


Overall, 104 patients (36% women, 64% African American) were randomized, and the study was terminated early because of funding limitations. At 180 days, 21 of 52 (40.4%) of patients randomized to predischarge initiation were treated with ivabradine compared with 6 of 52 (11.5%) randomized to usual care (odds ratio 5.19, 95% CI 1.88-14.33, P = .002). The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011). Patient-reported outcomes, β-blocker use/dose, and safety events were similar (all P > .05).
CONCLUSIONS


Ivabradine initiation prior to discharge among stabilized HF patients increased ivabradine use at 180 days and lowered heart rates without reducing β-blockers or increasing adverse events. As the trial did not achieve the planned enrollment, additional studies are needed.",2020,"The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011).","['Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min', '104 patients (36% women, 64% African American', 'patients with stable chronic HF with reduced ejection fraction (EF', 'stabilized acute HF patients', 'Heart Failure']","['ivabradine versus usual care', 'Ivabradine', 'ivabradine']","['safety events', 'heart failure (HF) hospitalization', 'proportion of patients on ivabradine', 'heart rate', 'heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.204552,"The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC. Electronic address: robert.mentz@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Gudaye', 'Initials': 'G', 'LastName': 'Tasissa', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Heitner', 'Affiliation': 'New York Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Cole', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Mahazarin', 'Initials': 'M', 'LastName': 'Ginwalla', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Old', 'Affiliation': 'Sentara Cardiovascular Research Institute, Norfolk, VA.'}, {'ForeName': 'Abraham S', 'Initials': 'AS', 'LastName': 'Salacata', 'Affiliation': 'Great Lakes Heart Center of Alpena, Alpena, MI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bigelow', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2019.12.024']
461,32163613,Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab.,"Denosumab is associated with continued gains in hip and spine BMD with up to 10 years of treatment in postmenopausal women with osteoporosis. Despite potent inhibition of bone remodeling, findings in nonhuman primates suggest modeling-based bone formation (MBBF) may persist during denosumab treatment. This study assessed whether MBBF in the femoral neck (FN) is preserved in the context of inhibited remodeling in subjects receiving denosumab. This open-label study enrolled postmenopausal women with osteoporosis who had received two or more doses of denosumab (60 mg subcutaneously every 6 months [Q6M]) per standard of care and were planning elective total hip replacement (THR) owing to osteoarthritis of the hip. Transverse sections of the FN were obtained after THR and analyzed histomorphometrically. MBBF, based on fluorochrome labeling and presence of smooth cement lines, was evaluated in cancellous, endocortical, and periosteal envelopes of the FN. Histomorphometric parameters were used to assess MBBF and remodeling-based bone formation (RBBF) in denosumab-treated subjects (n = 4; mean age = 73.5 years; range, 70 to 78 years) and historical female controls (n = 11; mean age = 67.8 years; range, 62 to 80 years) obtained from the placebo group of a prior study and not treated with denosumab. All analyses were descriptive. All subjects in both groups exhibited MBBF in the periosteal envelope; in cancellous and endocortical envelopes, all denosumab-treated subjects and 81.8% of controls showed evidence of MBBF. Compared with controls, denosumab-treated subjects showed 9.4-fold and 2.0-fold higher mean values of MBBF in cancellous and endocortical envelopes, respectively, whereas RBBF mean values were 5.0-fold and 5.3-fold lower. In the periosteal envelope, MBBF and RBBF rates were similar between subjects and controls. These results demonstrate the occurrence of MBBF in the human FN and suggest that denosumab preserves MBBF while inhibiting remodeling, which may contribute to the observed continued gains in BMD over time after remodeling is maximally inhibited. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,"All subjects in both groups exhibited MBBF in the periosteal envelope; in cancellous and endocortical envelopes, all denosumab-treated subjects and 81.8% of controls showed evidence of MBBF.","['postmenopausal women with osteoporosis', 'Human Femoral Neck in Subjects Treated With', 'enrolled postmenopausal women with osteoporosis who had received ≥2 doses of', 'age=73.5 [70-78] years) and historical female controls (n=11; mean [range] age=67.8 [62-80] years) obtained from the placebo group of a prior study and not treated with', 'subjects receiving denosumab']","['denosumab', 'denosumab (60 mg subcutaneously Q6M) per standard of care and were planning elective total hip replacement (THR', 'Denosumab', 'MBBF']","['RBBF mean values', 'MBBF and RBBF rates', 'MBBF', 'MBBF and remodeling-based bone formation (RBBF']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",,0.0211387,"All subjects in both groups exhibited MBBF in the periosteal envelope; in cancellous and endocortical envelopes, all denosumab-treated subjects and 81.8% of controls showed evidence of MBBF.","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Mathias P', 'Initials': 'MP', 'LastName': 'Bostrom', 'Affiliation': 'Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'Jeri W', 'Initials': 'JW', 'LastName': 'Nieves', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Helen Hayes Hospital, West Haverstraw, NY, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Pannacciulli', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Columbia University, New York, NY, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4006']
462,32100960,Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis.,"Anti-tumor necrosis factor (anti-TNF) drugs are often prescribed for the treatment of rheumatoid arthritis (RA) and other immune-mediated inflammatory diseases. Although this treatment has been shown to be effective in many patients, up to 40% of patients do not achieve disease control. Drug concentration in plasma may be a factor affecting the observed variability in therapeutic response. In this study, we aimed to identify the plasma concentrations of the anti-TNF certolizumab pegol (CZP), associated with improvement in disease activity in patients with RA. Data were pooled from three randomized, controlled clinical trials with a combined total of 1,935 patients analyzed. Clinical outcomes of low disease activity (LDA) and remission were defined as Disease Activity Score in 28 joints with C-reactive protein (DAS28(CRP)) ≤ 2.7 and < 2.3, respectively. Quartile analysis results indicated that there may be an exposure-response relationship between CZP concentration and LDA/remission outcomes at weeks 12 and 24; the association was strongest for LDA (P < 0.05). Receiver operating characteristic (ROC) analysis showed that CZP concentrations ≥ 28.0 μg/ml at week 12, and ≥ 17.6 μg/ml at week 24, were associated with a greater likelihood of achieving LDA/remission outcomes. Although confirmatory studies are warranted to define the optimal CZP therapeutic range at weeks 12 and 24, these data indicate that CZP concentrations may be associated with improvement of disease activity.",2020,"Receiver operating characteristic (ROC) analysis showed that CZP concentrations ≥28.0 μg/mL at Week 12, and ≥17.6 μg/mL at Week 24, were associated with a greater likelihood of achieving LDA/remission outcomes.","['patients with RA', '1,935 patients analysed', 'Patients with Rheumatoid Arthritis']",['anti-TNF certolizumab pegol (CZP'],"['Disease Activity Score', 'low disease activity (LDA) and remission', 'disease activity', 'CZP concentration and LDA/remission outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",1935.0,0.046119,"Receiver operating characteristic (ROC) analysis showed that CZP concentrations ≥28.0 μg/mL at Week 12, and ≥17.6 μg/mL at Week 24, were associated with a greater likelihood of achieving LDA/remission outcomes.","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Immunology, CIC1408, GIMAP EA3064, Université Jean Monnet, Saint Étienne, France.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Marotte', 'Affiliation': 'Department of Rheumatology, SAINBOISE AINBIOSE INSERM 1059, University of Lyon, Saint-Étienne, France.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'Division of Rheumatology, Allergy & Immunology, University of California San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology, University Hospital of Tours, EA 7501, Tours, France.'}, {'ForeName': 'Tore K', 'Initials': 'TK', 'LastName': 'Kvien', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'de Longueville', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Mulleman', 'Affiliation': 'Department of Rheumatology, University Hospital of Tours, EA 7501, Tours, France.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Department of Medicine, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Vande Casteele', 'Affiliation': 'Department of Medicine, University of California San Diego, La Jolla, California, USA.'}]",Clinical and translational science,['10.1111/cts.12760']
463,31188145,A Randomized Control Trial of Comparing Ultrasound-Guided Ozone (O2-O3) vs Corticosteroid Injection in Patients With Shoulder Impingement.,"INTRODUCTION


Ozone has been recently used as a safe alternative treatment in musculoskeletal disorders with fewer adverse effects than corticosteroids. The aim of this study was to compare the efficacy of a single injection of ozone with that of a corticosteroid in the treatment of shoulder impingement.
DESIGN


Thirty patients with shoulder pain and clinical signs and symptoms of impingement were randomly assigned into two groups: ultrasound-guided injection with ozone or corticosteroid. Patients' symptoms were evaluated by visual analog scale, constant score, shoulder pain and disability scale, shoulder range of motion, and ultrasonographic measures before treatment, 2 wks, and 2 mos after injections.
RESULTS


Patients' visual analog scale, shoulder pain and disability scale and constant score improved significantly in both groups (P < 0.001), but the benefits were in favor of corticosteroid group (P < 0.001). At intervals between the two follow-ups, an improvement was observed in the visual analog scale score among patients receiving ozone, whereas during the same interval, patients' pain slightly worsened in the corticosteroid group. The range of motion and ultrasonographic measures did not show statistical differences between the two groups.
CONCLUSIONS


Corticosteroid injection improves the pain and disability scores more significantly than a one-time ozone injection. Ozone may serve as an alternative modality in treating shoulder impingement when the use of steroids is contraindicated.",2019,"RESULTS


Patients' VAS, SPADI and Constant score improved significantly in both groups (P<0.001), but the benefits were in favor of corticosteroid group (P<0.001).","['30 patients with shoulder pain and clinical signs and symptoms of impingement', 'patients with shoulder impingement', 'shoulder impingement']","['ultrasound-guided injection with ozone or corticosteroid', 'ultrasound-guided ozone (O2-O3) vs corticosteroid injection', 'Corticosteroid injection', 'corticosteroid']","['Visual Analog Scale (VAS), Constant score, Shoulder Pain and Disability Scale (SPADI), shoulder range of motion (ROM) and ultra-sonographic measures', 'pain', 'VAS, SPADI and Constant score', 'ROM and ultra-sonographic measures', 'VAS score', 'pain and disability scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0575545', 'cui_str': 'Joint movement: shoulder'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0464197,"RESULTS


Patients' VAS, SPADI and Constant score improved significantly in both groups (P<0.001), but the benefits were in favor of corticosteroid group (P<0.001).","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Babaei-Ghazani', 'Affiliation': 'From the Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran (AB-G, SE, TA, FG); Mission Pain and Spine, Mission Viejo, California (HRF); Physical Medicine and Rehabilitation Research Center, Department of Physical Medicine and Rehabilitation, Tabriz University of Medical Sciences, Tabriz, Iran (BE); and Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran (MSK).'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Fadavi', 'Affiliation': ''}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Eftekharsadat', 'Affiliation': ''}, {'ForeName': 'Safoora', 'Initials': 'S', 'LastName': 'Ebadi', 'Affiliation': ''}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ahadi', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ghazaei', 'Affiliation': ''}, {'ForeName': 'Mohamad Sadegh', 'Initials': 'MS', 'LastName': 'Khabbaz', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001240']
464,32240304,Supplementation with Fortified Lipid-Based and Blended Complementary Foods has Variable Impact on Body Composition Among Rural Bangladeshi Children: A Cluster-Randomized Controlled Trial.,"BACKGROUND


Complementary food supplementation enhances linear growth and may affect body composition in children.
OBJECTIVE


We aimed to determine the effect of complementary food supplements provided from the age of 6 to 18 mo on fat-free mass (FFM) and fat mass (FM) gain among children in rural Bangladesh.
METHODS


In an unblinded, cluster-randomized, controlled trial we tested the effects of 4 complementary food supplements for 1 y [chickpea, rice lentil, Plumpy'doz, and wheat-soy-blend++ (WSB++)] compared with no supplements on linear growth. Body composition was estimated using weight-length-based, age- and sex-specific equations at 6, 9, 12, 15, and 18 mo and postintervention aged 24 mo. Generalized estimating equations (GEEs) were applied to estimate the effect of each complementary food on mean FFM and FM from 9 to 18 and 24 mo compared with the control, adjusting for baseline measures. Sex interactions were also explored.
RESULTS


In total, 3592 (65.9% of enrolled) children completed all anthropometric assessments. Estimated FFM and FM (mean ± SD) were 5.3 ± 0.6 kg and 1.4 ± 0.4 kg, respectively, at the age of 6 mo. Mean ± SE FFM and FM from 9 to 18 mo were 75.4 ± 14.0 g and 32.9 ± 7.1 g, and 61.0 ± 16.6 g and 30.0 ± 8.4 g, higher with Plumpy'doz and chickpea foods, respectively, than the control (P < 0.001). Estimated FFM was 41.5 ± 16.6 g higher in rice-lentil-fed versus control (P < 0.05) children. WSB++ had no impact on FFM or FM. A group-sex interaction (P < 0.1) was apparent with Plumpy'doz and rice-lentil foods, with girls involved in the intervention having higher estimated FFM and FM than control girls compared with no significant effect in boys. At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01).
CONCLUSIONS


In this randomized trial, supplementation effected small shifts in apparent body composition in rural Bangladeshi children. Where seen, FFM increments were twice that of FM, in proportion to these compartments, and more pronounced in girls. FFM increased in line with reported improvements in length. This trial was registered at clinicaltrials.gov as NCT01562379.",2020,"At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01).
","['Rural Bangladeshi Children', 'children', 'rural Bangladeshi children']","['Fortified Lipid-Based and Blended Complementary Foods', ""4 complementary food supplements for 1 y [chickpea, rice lentil, Plumpy'doz, and wheat-soy-blend++ (WSB"", 'WSB']","['FFM or FM', 'Body composition', 'Estimated FFM and FM (mean\xa0±\xa0SD', 'fat-free mass (FFM) and fat mass (FM) gain', 'Mean\xa0±', 'Body Composition', 'length', 'FFM', 'FFM and FM']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}]","[{'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",3592.0,0.190282,"At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01).
","[{'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Campbell', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'Mehra', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alamgir', 'Initials': 'A', 'LastName': 'Kabir', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Schulze', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Abu Ahmed', 'Initials': 'AA', 'LastName': 'Shamim', 'Affiliation': 'James P Grant School of Public Health, Bangladesh Rural Advancement Committee (BRAC), University, Dhaka, Bangladesh.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa061']
465,32243943,"Combined Treatment With Hydrocortisone, Vitamin C, and Thiamine for Sepsis and Septic Shock: A Randomized Controlled Trial.","BACKGROUND


Whether hydrocortisone, vitamin C, and thiamine treatment can reduce the mortality of patients with sepsis is controversial.
RESEARCH QUESTION


To evaluate the efficacy and safety of hydrocortisone, vitamin C, and thiamine combination treatment for patients with sepsis or septic shock (HYVCTTSSS).
STUDY DESIGN AND METHODS


This single-blind, randomized controlled trial evaluated treatment with hydrocortisone (50 mg every 6 h for 7 days), vitamin C (1.5 g every 6 h for 4 days), and thiamine (200 mg every 12 h for 4 days) vs placebo (normal saline) in patients with sepsis. The intention-to-treat analysis was used. Primary outcome was 28-day all-cause mortality, and secondary outcomes were organ protection, procalcitonin reduction, and adverse events related to hydrocortisone, vitamin C, and thiamine.
RESULTS


Eighty patients were randomized to receive combination treatment (n = 40) or normal saline (n = 40). No difference in 28-day all-cause mortality was observed (27.5% vs 35%, respectively; P = .47); however, treatment was associated with a significant improvement of 72-h change in Sequential Organ Failure Assessment score (P = .02). In adverse events analysis, the treatment group exhibited more incidents of hypernatremia (P = .005). In prespecified subgroup analysis, patients of the treatment subgroup diagnosed with sepsis within 48 h showed lower mortality than those in the control subgroup (P = .02). The study was terminated after the midterm analysis.
INTERPRETATION


Among patients with sepsis or septic shock, the combination of hydrocortisone, vitamin C, and thiamine did not reduce mortality compared with placebo.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT03258684; URL: www.clinicaltrials.gov.",2020,"In adverse events analysis, the treatment group exhibited more incidents of hypernatremia (P = 0.005).","['sepsis and septic shock (HYVCTTSSS', 'Eighty patients', 'patients with sepsis or septic shock', 'patients with sepsis']","['hydrocortisone, vitamin C, and thiamine treatment', 'placebo (normal saline', 'normal saline', 'vitamin C', 'hydrocortisone, vitamin C, and thiamine combination treatment', 'placebo', 'hydrocortisone, vitamin C, and thiamine', 'thiamine', 'hydrocortisone']","['lower mortality', '28-day all-cause mortality', '72-h ΔSOFA score', 'efficacy and safety', '28-day all-cause mortality, and secondary outcomes were organ protection, procalcitonin reduction, and adverse events related to hydrocortisone, vitamin C, and thiamine', 'incidents of hypernatremia']","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0020488', 'cui_str': 'Hypernatremia'}]",80.0,0.791428,"In adverse events analysis, the treatment group exhibited more incidents of hypernatremia (P = 0.005).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': ""Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou; Department of Critical Care Medicine, Dongguan People's Hospital, Dongguan.""}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Yuexun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Organ Transplant, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Organ Transplant, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Zhongran', 'Initials': 'Z', 'LastName': 'Cen', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Zhanguo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou. Electronic address: zhguoliu@163.com.'}]",Chest,['10.1016/j.chest.2020.02.065']
466,32167712,Modified wallace anastomotic technique reduces ureteroenteric stricture rates after ileal conduit urinary diversion.,"PURPOSE


To compare perioperative outcomes, complications and anastomotic stricture rate in a contemporary series of patients who underwent open radical cystectomy (RC) with modified Wallace anastomotic technique versus traditional ileal conduit.
MATERIALS AND METHODS


Study enrolled 180 patients, of whom 140 were randomized and underwent RC; seventy were randomized to group I and the seventy to the group II. For the primary objective, we hypothesized that the rate of ureteroenteric strictures would be at least 20 % lower in the second group. Secondary end points included rate of anastomotic leak, surgical time, deterioration of the upper tract, intraoperative blood loss and patient-reported quality of life (HRQOL). The modified Wallace 1 technique involved eversion of the ureteral plate and bowel mucosa edges, which were anastomosed together in running fashion, while the outher anastomotic wall was augmented with sero-serosal interrupted sutures.
RESULTS


The mean (SD) follow-up time was 26.1 (5.7) months in group I and 25.2 (4.8) months in group II, during which, anastomotic stricture was observed in 8 patients (12%) from the first and 2 patients (3%) from the second group (p < 0.05). The anastomotic leakage rate was significantly higher in first group (17% vs. 8.5%, p < 0.05), while patient-reported HRQOL outcomes were similar between groups after the 12 month follow-up period.
CONCLUSIONS


By using a modified Wallace technique, we were able to significantly lower anastomotic stricture and anastomotic leakage rates, which are major issues in minimizing both short- and long-term postoperative complications.",2020,"The anastomotic leakage rate was significantly higher in first group (17% vs. 8.5%, p < 0.05), while patient-reported HRQOL outcomes were similar between groups after the 12 month follow-up period.
","['Study enrolled 180 patients, of whom 140 were randomized and underwent RC; seventy were randomized to group', 'ileal conduit urinary diversion', 'patients who underwent']","['modified Wallace technique', 'open radical cystectomy (RC) with modified Wallace anastomotic technique versus traditional ileal conduit', 'Modified wallace anastomotic technique']","['anastomotic stricture', 'HRQOL outcomes', 'anastomotic stricture and anastomotic leakage rates', 'anastomotic leakage rate', 'perioperative outcomes, complications and anastomotic stricture rate', 'ureteroenteric stricture rates', 'rate of ureteroenteric strictures', 'rate of anastomotic leak, surgical time, deterioration of the upper tract, intraoperative blood loss and patient-reported quality of life (HRQOL', 'mean (SD) follow-up time']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}, {'cui': 'C0042020', 'cui_str': 'Urinary Diversion'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}]","[{'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",180.0,0.0405474,"The anastomotic leakage rate was significantly higher in first group (17% vs. 8.5%, p < 0.05), while patient-reported HRQOL outcomes were similar between groups after the 12 month follow-up period.
","[{'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Kavaric', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Sabovic', 'Initials': 'S', 'LastName': 'Eldin', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Radovic', 'Initials': 'R', 'LastName': 'Nenad', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Pratljacic', 'Initials': 'P', 'LastName': 'Dragan', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Vukovic', 'Affiliation': 'Department of Urology, Clinical Center of Montenegro, Ljubljanska, Podgorica, Montenegro.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0417']
467,32236329,The effect of home exercise on the posture and mobility of people with HAM/TSP: a randomized clinical trial.,"BACKGROUND


Physical therapy has positive results in people with tropical spastic paraparesis (TSP). However, mobility and distance from rehabilitation centers limit the participation in outpatient programs.
OBJECTIVE


To evaluate the impact of a home exercise program on the posture and functional mobility of people with TSP.
METHODS


A randomized controlled trial comparing three groups of people who performed guided exercises from a guidebook for six months: supervised (SG), unsupervised (WG), and control (CG). Primary outcomes: postural angles (SAPO®) and functional mobility (TUG).
SECONDARY OUTCOMES


gait parameters (CVMob®).
RESULTS


The protocol described in the guidebook improved postural angles and functional mobility. There were also positive gait parameter effects (p<0.05). SG presented better responses than WG did, but both were preferable to CG.
CONCLUSION


Home exercises oriented by a guidebook may benefit posture, functional mobility and gait parameters in people with TSP, and physiotherapist supervision can ensure better results.",2020,There were also positive gait parameter effects (p<0.05).,"['people with HAM/TSP', 'people with tropical spastic paraparesis (TSP', 'people with TSP']","['home exercise program', 'home exercise', 'guided exercises from a guidebook for six months: supervised (SG), unsupervised (WG), and control (CG']","['gait parameters (CVMob®', 'postural angles (SAPO®) and functional mobility (TUG', 'postural angles and functional mobility', 'positive gait parameter effects']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0076560', 'cui_str': 'Thrombospondin'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0376666', 'cui_str': 'Guidebooks'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.131953,There were also positive gait parameter effects (p<0.05).,"[{'ForeName': 'Renata de Sousa', 'Initials': 'RS', 'LastName': 'Mota', 'Affiliation': 'Centro de Ciência e Tecnologia em Energia e Sustentabilidade, Universidade Federal do Recôncavo da Bahia, Feira de Santana, BA, Brazil.'}, {'ForeName': 'Maíra Carvalho', 'Initials': 'MC', 'LastName': 'Macêdo', 'Affiliation': 'Fundação para Neurologia e Neurocirurgia, Instituto do Cérebro, Salvador, BA, Brazil.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Corradini', 'Affiliation': 'Universidade de Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Naiane Araújo', 'Initials': 'NA', 'LastName': 'Patrício', 'Affiliation': 'Departamento de Tecnologias de Saúde, Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brazil.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Centro de Matemática, Computação e Cognição, Universidade Federal do ABC, São Paulo, SP, Brazil.'}, {'ForeName': 'Katia Nunes', 'Initials': 'KN', 'LastName': 'Sá', 'Affiliation': 'Departamento de Fisioterapia, Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brazil.'}]",Arquivos de neuro-psiquiatria,['10.1590/0004-282x20190169']
468,32237143,Effectiveness of a Group Game Intervention in Reducing Preoperative Anxiety Levels of Children and Parents: A Randomized Controlled Trial.,"Surgical experiences are often stressful for children and their parents. This study aimed to determine the effect of a group game intervention on the preoperative anxiety levels of 94 parent-child dyads who were awaiting elective minor surgery at a pediatric surgery clinic. The experimental group intervention included routine preoperative preparation and a group (ie, child, parent, and researcher) game. After the parent dressed the child for surgery, a research team member assessed the child's and parent's anxiety levels using the Facial Affective Scale and Visual Facial Anxiety Scale, respectively. Before the child was transferred to the OR, the research team member reassessed both anxiety levels. When compared to the control group, the results showed that children and parents involved in facilitated group play experienced significantly decreased anxiety levels (P < .001).",2020,"When compared to the control group, the results showed that children and parents involved in facilitated group play experienced significantly decreased anxiety levels (P < .001).","['94 parent-child dyads who were awaiting elective minor surgery at a pediatric surgery clinic', 'Children and Parents']","['Group Game Intervention', 'routine preoperative preparation and a group (ie, child, parent, and researcher) game', 'group game intervention']","['preoperative anxiety levels', 'Facial Affective Scale and Visual Facial Anxiety Scale', 'anxiety levels', 'Preoperative Anxiety Levels']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgical Procedure'}, {'cui': 'C3839137', 'cui_str': 'Pediatric surgery clinic'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0242368,"When compared to the control group, the results showed that children and parents involved in facilitated group play experienced significantly decreased anxiety levels (P < .001).","[{'ForeName': 'Seher', 'Initials': 'S', 'LastName': 'Ünver', 'Affiliation': ''}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Güray', 'Affiliation': ''}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Aral', 'Affiliation': ''}]",AORN journal,['10.1002/aorn.12990']
469,32016532,Methylnaltrexone for the treatment of opioid-induced constipation and gastrointestinal stasis in intensive care patients. Results from the MOTION trial.,"PURPOSE


Constipation can be a significant problem in critically unwell patients, associated with detrimental outcomes. Opioids are thought to contribute to the mechanism of bowel dysfunction. We tested if methylnaltrexone, a pure peripheral mu-opioid receptor antagonist, could reverse opioid-induced constipation.
METHODS


The MOTION trial is a multi-centre, double blind, randomised placebo-controlled trial to investigate whether methylnaltrexone alleviates opioid-induced constipation (OIC) in critical care patients. Eligibility criteria included adult ICU patients who were mechanically ventilated, receiving opioids and were constipated (had not opened bowels for a minimum 48 h) despite prior administration of regular laxatives as per local bowel management protocol. The primary outcome was time to significant rescue-free laxation. Secondary outcomes included gastric residual volume, tolerance of enteral feeds, requirement for rescue laxatives, requirement for prokinetics, average number of bowel movements per day, escalation of opioid dose due to antagonism/reversal of analgesia, incidence of ventilator-associated pneumonia, incidence of diarrhoea and Clostridium difficile infection and finally 28 day, ICU and hospital mortality.
RESULTS


A total of 84 patients were enrolled and randomized (41 to methylnaltrexone and 43 to placebo). The baseline demographic characteristics of the two groups were generally well balanced. There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22). There were no significant differences in the majority of secondary outcomes, particularly days 1-3. However, during days 4-28, there were fewer median number of bowel movements per day in the methylnaltrexone group, (p = 0.01) and a greater incidence of diarrhoea in the placebo group (p = 0.02). There was a marked difference in mortality between the groups, with ten deaths in the methylnaltrexone group and two in the placebo group during days 4-28 (p = 0.007).
CONCLUSION


We found no evidence to support the addition of methylnaltrexone to regular laxatives for the treatment of opioid-induced constipation in critically ill patients; however, the confidence interval was wide and a clinically important difference cannot be excluded.",2020,"There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22).","['critical care patients', '84 patients were enrolled and randomized (41 to', 'intensive care patients', 'Eligibility criteria included adult ICU patients who were mechanically ventilated, receiving opioids and were constipated (had not opened bowels for a minimum 48\xa0h) despite prior administration of regular laxatives as per local bowel management protocol']","['methylnaltrexone and 43 to placebo', 'methylnaltrexone alleviates opioid-induced constipation (OIC', 'Methylnaltrexone', 'placebo', 'methylnaltrexone']","['median number of bowel movements', 'time to rescue-free laxation', 'constipation and gastrointestinal stasis', 'mortality', 'gastric residual volume, tolerance of enteral feeds, requirement for rescue laxatives, requirement for prokinetics, average number of bowel movements per day, escalation of opioid dose due to antagonism/reversal of analgesia, incidence of ventilator-associated pneumonia, incidence of diarrhoea and Clostridium difficile infection and finally 28\xa0day, ICU and hospital mortality', 'incidence of diarrhoea', 'time to significant rescue-free laxation']","[{'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0333138', 'cui_str': 'Stasis (morphologic abnormality)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3665864', 'cui_str': 'Gastric residuals'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",84.0,0.631063,"There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22).","[{'ForeName': 'Parind B', 'Initials': 'PB', 'LastName': 'Patel', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK. parind.patel@nhs.net.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Brett', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Callaghan"", 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Anjum', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cross', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}]",Intensive care medicine,['10.1007/s00134-019-05913-6']
470,32151822,A 4-item PRECISE-DAPT score for dual antiplatelet therapy duration decision-making.,"The originally-proposed PRECISE-DAPT score is a 5-item risk score supporting decision-making for dual antiplatelet therapy 1  duration after PCI. It is unknown if a simplified version of the score based on 4 factors (age, hemoglobin, creatinine clearance, prior bleeding), and lacking white-blood cell count, retains potential to guide DAPT duration. The 4-item PRECISE-DAPT was used to categorize 10,081 patients who were randomized to short (3-6 months) or long (12-24 months) DAPT regimen according to high (HBR defined by PRECISE-DAPT ≥25 points) or non-high bleeding risk (PRECISE-DAPT<25) status. Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11). Only non-HBR patients experienced lower net clinical adverse events (NACE) with longer DAPT (p int  = 0.043). A 4-item simplified version of the PRECISE-DAPT score retains the potential to categorize patients who benefit from prolonged DAPT without concomitant bleeding liability from those who do not.",2020,"Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11).","['10,081 patients who were randomized to short (3-6 months) or long (12-24 months']",['DAPT'],"['ischemic risks', 'net clinical adverse events (NACE', 'bleeding rates in HBR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",[],"[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0200107,"Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Department of Clinical and Experimental Medicine, Policlinic ""G. Martino"", University of Messina, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam, The Netherlands.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Feres', 'Affiliation': 'Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Ewout W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': 'Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital. Electronic address: marco.valgimigli@insel.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.014']
471,32246266,Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging.,"INTRODUCTION


Transcatheter aortic valve implantation (TAVI) is a safe and effective treatment for inoperable, intermediate- or high-risk patients with severe symptomatic aortic stenosis and has been associated with excellent clinical outcomes. A clinically relevant remaining problem is aortic regurgitation (AR) post-TAVI, which is associated with increased mortality. Therefore, we conducted a prospective randomised trial to assess the safety and efficacy of a first-generation self-expandable valve (SEV; CoreValve) and a third-generation balloon-expandable valve (BEV; Sapien 3) with respect to clinical outcomes and AR as determined quantitatively by magnetic resonance imaging (MRI).
METHODS


The ELECT study was an investigator-initiated, single-centre trial involving patients with severe symptomatic aortic stenosis and with a clinical indication for transfemoral TAVI. Fifty-six patients were randomly assigned to the BEV or SEV group.
RESULTS


AR determined quantitatively by MRI was lower in the BEV than in the SEV group [regurgitant fraction: 1.1% (0-8.0) vs 8.7% (3.0-14.8) for SEV; p = 0.01]. Secondary endpoints according to the criteria of the Second Valve Academic Research Consortium (VARC-2) showed BEV to have better early safety [0 (0%) vs 8 (30%); p = 0.002] at 30 days and a lower risk of stroke [0 (0%) vs 5 (21%); p = 0.01], major adverse cardiac and cerebrovascular events [0 (0%) vs 10 (38%); p < 0.001] or death [0 (0%) vs 5 (19%); p = 0.02] in the 1st year compared with SEV.
CONCLUSIONS


The use of the latest generation of BEV was associated with less AR as quantitatively assessed by MRI. Although the use of MRI to quantify AR is not feasible in daily clinical practice, it should be considered as a surrogate endpoint for clinical outcomes in comparative studies of valves for TAVI. ClinicalTrials.gov number NCT01982032.",2020,"RESULTS


AR determined quantitatively by MRI was lower in the BEV than in the SEV group [regurgitant fraction: 1.1% (0-8.0) vs 8.7% (3.0-14.8) for SEV; p = 0.01].","['patients with severe symptomatic aortic stenosis and with a\xa0clinical indication for transfemoral TAVI', 'inoperable, intermediate- or high-risk patients with severe symptomatic aortic stenosis', 'Fifty-six patients']","['first-generation self-expandable valve (SEV; CoreValve) and a\xa0third-generation balloon-expandable valve (BEV', 'BEV or SEV', 'Transcatheter aortic valve implantation (TAVI', 'balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging']","['safety and efficacy', 'major adverse cardiac and cerebrovascular events', 'death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter aortic valve replacement'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter aortic valve replacement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",56.0,0.097307,"RESULTS


AR determined quantitatively by MRI was lower in the BEV than in the SEV group [regurgitant fraction: 1.1% (0-8.0) vs 8.7% (3.0-14.8) for SEV; p = 0.01].","[{'ForeName': 'N H M', 'Initials': 'NHM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abawi', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. mvoskuil@umcutrecht.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Urgel', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Samim', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nijhoff', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Nathoe', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'P A F M', 'Initials': 'PAFM', 'LastName': 'Doevendans', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'S A J', 'Initials': 'SAJ', 'LastName': 'Chamuleau', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'G E H', 'Initials': 'GEH', 'LastName': 'Leenders', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Leiner', 'Affiliation': 'Department of Radiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Abrahams', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01414-0']
472,30917698,Long-Term Outcomes of BMMSC Compared with BMMNC for Treatment of Critical Limb Ischemia and Foot Ulcer in Patients with Diabetes.,"We first compared long-term clinical outcomes in treating critical limb ischemia (CLI) and foot ulcer in patients with diabetes between autologous bone marrow mesenchymal stem cell (BMMSC) and bone-marrow-derived mononuclear cell (BMMNC) transplants. Forty-one patients were enrolled and followed up for 3 years. They received an 18-day standard treatment before stem cell transplantation. Patients with bilateral CLI and foot ulcer were injected intramuscularly or basally with BMMSC, BMMNC, or normal saline (NS). Cox model analysis showed significant differences in the hazard ratio (HR) for amputation with treatment by BMMSC (HR 0.21 [95% CI (0.05, 0.95)],  P  = 0.043), infection of foot (HR 5.30 [95% CI (1.89, 14.92)],  P  = 0.002), and age ≥64 (HR 3.01 [95% CI (1.11, 8.15)],  P  = 0.030), but no significant differences by BMMNC at 9 months after transplantation. Regarding ulcer healing and recurrence rate, the BMMSC group demonstrated a significant difference from the NS group during the 3-6 months after transplantation or healing, but the BMMNC group did not. This trial suggests that, compared with BMMNC treatment, BMMSC treatment leads to a longer time of limb salvage and blood flow improvement, and, when compared with conventional therapy, it can promote limb blood flow and ulcerative healing, and reduce ulcer recurrence and amputation within 9 months.",2019,"Regarding ulcer healing and recurrence rate, the BMMSC group demonstrated a significant difference from the NS group during the 3-6 months after transplantation or healing, but the BMMNC group did not.
","['Forty-one patients were enrolled and followed up for 3 years', 'patients with diabetes between autologous bone marrow mesenchymal stem cell (BMMSC) and bone-marrow-derived mononuclear cell (BMMNC) transplants', 'Patients with Diabetes', 'Patients with bilateral CLI and foot ulcer']","['BMMNC', 'BMMSC, BMMNC, or normal saline (NS', 'BMMSC']","['infection of foot', 'Critical Limb Ischemia and Foot Ulcer', 'ulcer recurrence and amputation', 'limb blood flow and ulcerative healing', 'ulcer healing and recurrence rate', 'time of limb salvage and blood flow improvement', 'hazard ratio (HR) for amputation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C4704952', 'cui_str': 'Bone Marrow Mesenchymal Stem Cells'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0085119', 'cui_str': 'Foot Ulcer'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0555973', 'cui_str': 'Infection of foot'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0085119', 'cui_str': 'Foot Ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0949591', 'cui_str': 'Limb Salvage'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",41.0,0.0370062,"Regarding ulcer healing and recurrence rate, the BMMSC group demonstrated a significant difference from the NS group during the 3-6 months after transplantation or healing, but the BMMNC group did not.
","[{'ForeName': 'Debin', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': '1 Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Youzhao', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""3 Department of Endocrinology, Banan People's Hospital of Chongqing, PR China.""}, {'ForeName': 'Wuquan', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ""4 Department of Endocrinology, Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital), Chongqing, PR China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""5 Department of Neurology, Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital), Chongqing, PR China.""}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': '2 Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing, PR China.'}, {'ForeName': 'Qinan', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': '2 Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing, PR China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': '2 Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing, PR China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': '6 Outpatient Department, Southwest Hospital, Third Military Medical University, Chongqing, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': '1 Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': '1 Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': '2 Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing, PR China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': '1 Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, PR China.'}]",Cell transplantation,['10.1177/0963689719835177']
473,31972765,Treatment Trajectories During and After a Medication Trial for Opioid Use Disorder: Moving from Research as Usual to Treatment as Usual.,"OBJECTIVES


The effectiveness of treatment incorporating relapse prevention medications for opioid use disorder (OUD) is typically examined in research using rigidly predefined endpoints of success versus failure, usually over a single episode of care. But this perspective may not adequately portray the nonlinear trajectories typical of real-world treatment courses in this chronic, remitting, and relapsing disorder.
METHODS


This descriptive study examined 12-month treatment trajectories of n = 60 patients enrolled at a single site of a larger multisite randomized controlled trial examining the comparative effectiveness of buprenorphine versus extended-release naltrexone. While the parent study provided medication treatment through the research protocol for 6 months, this study documents treatment up to 12 months, including medications, provided through standard community resources (treatment as usual) outside of the protocol.
RESULTS


Some patients continued medications past the end of the study intervention, whereas others did not. Some patients initiated medications other than the one assigned by the study. Some patients switched from 1 medication to the other. Many patients returned to treatment after 1 or more periods of dropout and/or relapse. Patients utilized multiple episodes of bed-based care, including short-term acute residential and long-term residential treatment, and also recovery housing supports. Described trajectories are also depicted graphically. At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%).
CONCLUSIONS


This description of nonlinear treatment trajectories highlights the potential benefits of flexibility and optimism in the promotion of re-engagement, despite interim outcomes that might traditionally be considered ""failure"" endpoints.",2020,"At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%).
","['n\u200a=\u200a60 patients enrolled at a single site', 'Patients utilized multiple episodes of bed-based care, including short-term acute residential and long-term residential treatment, and also recovery housing supports']",['buprenorphine versus extended-release naltrexone'],"['rates of continuous treatment retention', 'rates of cross-sectional treatment engagement including return to treatment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0565960', 'cui_str': 'Multiple episode (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}]",60.0,0.0388449,"At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%).
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Maryland Treatment Centers, Baltimore, MD (MF, RB, MR); Johns Hopkins University School of Medicine, Baltimore, MD (MF); University of Texas Southwestern Medical Center, Dallas, TX (HTV); New York University School of Medicine, New York, NY (JR, JL); New York State Psychiatric Institute, Columbia University Medical Center, New York, NY (EN).'}, {'ForeName': 'Hoa T', 'Initials': 'HT', 'LastName': 'Vo', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Burgower', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ruggiero', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': ''}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000592']
474,31419257,Micro-costing and a cost-consequence analysis of the 'Girls Active' programme: A cluster randomised controlled trial.,"Physical inactivity has been identified as a leading risk factor for premature mortality globally, and adolescents, in particular, have low physical activity levels. Schools have been identified as a setting to tackle physical inactivity. Economic evidence of school-based physical activity programmes is limited, and the costs of these programmes are not always collected in full. This paper describes a micro-costing and cost-consequence analysis of the 'Girls Active' secondary school-based programme as part of a cluster randomised controlled trial (RCT). Micro-costing and cost-consequence analyses were conducted using bespoke cost diaries and questionnaires to collect programme delivery information. Outcomes for the cost-consequence analysis included health-related quality of life measured by the Child Health Utility-9D (CHU-9D), primary care General Practitioner (GP) and school-based (school nurse and school counsellor) service use as part of a cluster RCT of the 'Girls Active' programme. Overall, 1,752 secondary pupils were recruited and a complete case sample of 997 participants (Intervention n = 570, Control n = 427) was used for the cost-consequence analysis. The micro-costing analysis demonstrated that, depending upon how the programme was delivered, 'Girls Active' costs ranged from £1,054 (£2 per pupil, per school year) to £3,489 (£7 per pupil, per school year). The least costly option was to absorb 'Girls Active' strictly within curriculum hours. The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the 'Girls Active' programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes. This paper provides recommendations for those gathering cost and service use data in school settings to supplement validated and objective measures, furthering economic research in this field. Trial registration: -ISRCTN, ISRCTN10688342.",2019,"The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the 'Girls Active' programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes.","['1,752 secondary pupils were recruited and a complete case sample of 997 participants (Intervention n = 570, Control n = 427', ""Girls Active' programme""]",[],"[""health-related quality of life measured by the Child Health Utility-9D (CHU-9D), primary care General Practitioner (GP) and school-based (school nurse and school counsellor) service use as part of a cluster RCT of the 'Girls Active' programme""]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0302833', 'cui_str': 'School nurse (occupation)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",997.0,0.0892724,"The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the 'Girls Active' programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes.","[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Charles', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Deirdre M', 'Initials': 'DM', 'LastName': 'Harrington', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Gorely', 'Affiliation': 'Department of Nursing, School of Health, Social Care and Life Sciences, University of the Highlands and Islands, Inverness, United Kingdom.'}, {'ForeName': 'Danielle H', 'Initials': 'DH', 'LastName': 'Bodicoat', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Sherar', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0221276']
475,30745078,Onset Time of Local Anesthesia After Single Injection in Toe Nerve Blocks: A Randomized Double-Blind Trial.,"PURPOSE


The study was conducted to investigate the onset time and safety profile of four different local anesthetic solutions.
DESIGN


Randomized controlled clinical trial study.
METHODS


One hundred twelve healthy volunteers were assigned to receive digital block on their second toe. Individuals were randomly assigned to one of the following groups: lidocaine 2%, lidocaine 2% with epinephrine, bupivacaine 0.5%, or bupivacaine 0.5% with epinephrine. Onset time was measured until detecting the absence of pinprick sensation. Oxygen saturation was measured in the infiltrated toe up to 60 minutes.
FINDINGS


The subjects in the groups of anesthetics with epinephrine had a significantly lower mean onset time. There were no significant differences regarding oxygen saturation between the groups and no adverse effects were recorded.
CONCLUSIONS


The use of anesthetics with epinephrine can be an effective form of local anesthetic for digital blocks when a rapid onset of action, prolonged duration of anesthesia, and vasoconstrictive action are required.",2019,"There were no significant differences regarding oxygen saturation between the groups and no adverse effects were recorded.
","['One hundred twelve healthy volunteers', 'Toe Nerve Blocks']","['digital block', 'Local Anesthesia', 'lidocaine', 'epinephrine', 'epinephrine, bupivacaine', 'bupivacaine 0.5% with epinephrine']","['Oxygen saturation', 'adverse effects', 'oxygen saturation', 'mean onset time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}]","[{'cui': 'C0860122', 'cui_str': 'Digital block'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",112.0,0.309998,"There were no significant differences regarding oxygen saturation between the groups and no adverse effects were recorded.
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Córdoba-Fernández', 'Affiliation': ''}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'González-Benítez', 'Affiliation': ''}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Lobo-Martín', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.09.014']
476,31515502,Catheter-based closure of the patent ductus arteriosus in preterm infants: considerations in the design of a randomized trial.,,2019,,['preterm infants'],['Catheter-based closure of the patent ductus arteriosus'],[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}]",[],,0.0770431,,"[{'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Backes', 'Affiliation': ""Center for Perinatal Research, Nationwide Children's Hospital, Columbus, OH, USA. carl.backesjr@nationwidechildrens.org.""}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, University of Bristol, Canynge Hall, Whiteladies Road, Bristol, UK.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Slaughter', 'Affiliation': ""Center for Perinatal Research, Nationwide Children's Hospital, Columbus, OH, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0484-9']
477,31944617,Who benefits from the intervention? Correlates of successful BMI reduction in the Texas Childhood Obesity Demonstration Project (TX-CORD).,"BACKGROUND


Many childhood obesity intervention studies report mean outcomes but do not explore the variation in responses and the characteristics of those who respond well.
OBJECTIVE


To identify child and family characteristics associated with improvement in the primary outcome, %BMI p95  , of the Texas Childhood Obesity Research Demonstration project (TX-CORD).
METHODS


The 12-month TX-CORD secondary prevention study randomized 549 children, ages 2 to 12 years, with BMI ≥85th percentile to the intensive intervention vs. the comparison program, with measurements at baseline, 3-, and 12-months. A growth mixture model was used to identify mutually exclusive latent %BMI p95  trajectories. Latent class regression tested associations between baseline characteristics and latent class membership.
RESULTS


A 2-class solution emerged after accounting for the effect of intervention randomization. Latent Class 1 participants (86% of sample) were characterized by mild-to-moderate obesity and demonstrated a significantly greater response to the intensive intervention between 0 and 3 months (slope-on-group = -0.931, p = 0.03). A rebound between 3 and 12 months was not significantly different between arms. Latent Class 2 participants (14%), who had severe obesity, demonstrated no difference in response between intervention groups. Characteristics associated with Class 1 membership included younger age (2-5 years vs. 6-12 years: OR 3.70, p = .035) and lower maternal BMI category (< 35 kg/m 2  vs. ≥ 35 kg/m 2  : OR 7.14, p < .0001).
CONCLUSIONS


The optimal target population for the intensive intervention are children who have milder obesity, are younger, and do not have a mother with severe obesity. Children with severe obesity may require different approaches.",2020,A rebound between 3 and 12 months was not significantly different between arms.,"['Children with severe obesity', '549 children, ages 2 to 12 years, with BMI ≥85th percentile to the intensive intervention vs. the comparison program, with measurements at baseline, 3-, and 12-months', 'children who have milder obesity, are younger, and do not have a mother with severe obesity']",[],"['lower maternal BMI category', 'response to the intensive intervention']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",549.0,0.0796709,A rebound between 3 and 12 months was not significantly different between arms.,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Barlow', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Durand', 'Affiliation': 'University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, Texas.'}, {'ForeName': 'Meliha', 'Initials': 'M', 'LastName': 'Salahuddin', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Austin Regional Campus, Austin, Texas.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'University of Texas at Austin Dell Medical School, Austin, Texas.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Butte', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Austin Regional Campus, Austin, Texas.'}]",Pediatric obesity,['10.1111/ijpo.12609']
478,32062864,"Efficacy of transcutaneous electrical acupoint stimulation combined with general anesthesia for sedation and postoperative analgesia in minimally invasive lung cancer surgery: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Multimodal opioid-sparing analgesia is a key component of an enhanced recovery pathway after surgery that aims to improve postoperative recovery. Transcutaneous electrical acupoint stimulation (TEAS) is assumed to alleviate pain and anxiety and to modify the autonomic nervous system. This study aimed to determine the efficacy of TEAS for sedation and postoperative analgesia in lung cancer patients undergoing thoracoscopic pulmonary resection.
METHODS


A total of 80 patients were randomized into two groups: the TEAS group and the sham TEAS combined with general anesthesia group. Postoperative pain levels at six, 24, 48 hours, and one month after surgery were measured using the visual analogue scale (VAS). Bispectral index (BIS) score during the TEAS prior to anesthetic induction, Observer's Assessment of Alertness/Sedation (OAAS) score, sufentanil consumption during postoperative patient-controlled intravenous analgesia (PCIA), number of total and effective attempts of PCIA pump use, and incidence of postoperative nausea and vomiting were recorded and analyzed statistically.
RESULTS


Patients in the TEAS group had significantly lower VAS scores at six, 24, and 48 hours after surgery (P < 0.01); lower BIS scores at 10, 20, and 30 minutes before induction (P < 0.01); lower levels of postoperative sufentanil consumption; lower number of PCIA attempts and effective rates (P < 0.01); lower incidences of nausea at 0, six, 24, and 48 hours; and lower incidence of vomiting at 24 hours after surgery (P < 0.05). The postoperative OAAS scores were similar between the groups.
CONCLUSIONS


TEAS could be a feasible approach for sedation and postoperative analgesia in thoracoscopic pulmonary resection.",2020,"Postoperative pain levels at six, 24, 48 hours, and one month after surgery were measured using the visual analogue scale (VAS).","['80 patients', 'minimally invasive lung cancer surgery', 'lung cancer patients undergoing thoracoscopic pulmonary resection']","['transcutaneous electrical acupoint stimulation combined with general anesthesia for sedation and postoperative analgesia', 'placebo', 'TEAS group and the sham TEAS combined with general anesthesia group', 'TEAS', 'Transcutaneous electrical acupoint stimulation (TEAS']","['BIS scores', 'PCIA attempts and effective rates', 'VAS scores', ""Bispectral index (BIS) score during the TEAS prior to anesthetic induction, Observer's Assessment of Alertness/Sedation (OAAS) score, sufentanil consumption during postoperative patient-controlled intravenous analgesia (PCIA), number of total and effective attempts of PCIA pump use, and incidence of postoperative nausea and vomiting"", 'Postoperative pain levels', 'visual analogue scale (VAS', 'incidence of vomiting', 'nausea', 'postoperative OAAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",80.0,0.232633,"Postoperative pain levels at six, 24, 48 hours, and one month after surgery were measured using the visual analogue scale (VAS).","[{'ForeName': 'Jiheng', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Department of Anesthesiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yunxiao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Department of Anesthesiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Department of Anesthesiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Neuroscience Research Institute and Department of Neurobiology, Peking University and Key Laboratory of Neuroscience of the Ministry of Education and the National Health Commission, Beijing, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Department of Medical Record Statistics, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Department of Medical Record Statistics, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiaozheng', 'Initials': 'X', 'LastName': 'Kang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), The First Department of Thoracic Surgery, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Wanpu', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), The First Department of Thoracic Surgery, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Department of Anesthesiology, Peking University Cancer Hospital and Institute, Beijing, China.'}]",Thoracic cancer,['10.1111/1759-7714.13343']
479,30476065,Fit & Strong! Plus Trial Outcomes for Obese Older Adults with Osteoarthritis.,"BACKGROUND AND OBJECTIVES


We compared the effectiveness of standard Fit & Strong! (F&S!; targets physical activity [PA]) to Fit & Strong! Plus (F&S! Plus; targets PA and dietary weight loss) on weight, diet quality, and PA outcomes.
RESEARCH DESIGN AND METHODS


We randomly assigned 413 overweight older adults with OA to the F&S! or F&S! Plus programs and assessed outcomes at 2 and 6 months.
RESULTS


The F&S! Plus group lost -2.0 ± 0.2 kg (mean ± SE, 2% of starting weight) at 2 months that was maintained at 6 months. Two- and 6-month BMI and waist circumference improved significantly in the F&S! Plus group (p < .001). Diet quality at 2 months showed greater improvement in the F&S! Plus group: 4.6 ± 0.7 versus 2.0 ± 0.7, p = .006, with no significant difference between groups at 6 months. The F&S! Plus group differentially improved on PA engagement at 2 months and at 2 and 6 months in joint pain (6-month mean ± SE: -1.5 ± 0.3 vs -0.6 ± 0.3, p = .02), function (-4.7 ± 0.9 vs -1.5 ± 0.9, p = .01), and 6-min walk test (29.5 ± 5.1 m vs 14.1 ± 5.2 m, p = .04).
DISCUSSION AND IMPLICATIONS


Adding a dietary weight loss component to F&S! achieved weight and waist circumference benefits that were maintained at 6 months. Importantly, the weight loss was accompanied by clinically meaningful improvements in OA symptoms and mobility. Future work should investigate minimum thresholds for weight reduction that improve long-term function in this population.",2020,Diet quality at 2 months showed greater improvement in the F&S!,"['Obese Older Adults with Osteoarthritis', '413 overweight older adults with OA to the F&S! or F&S']","['standard Fit & Strong', 'Plus (F&S', 'Fit & Strong']","['6-month BMI and waist circumference', 'F&S', 'weight and waist circumference benefits', 'weight loss', 'PA engagement', 'Diet quality', 'OA symptoms and mobility', 'weight, diet quality, and PA outcomes', 'joint pain']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}]",413.0,0.0401311,Diet quality at 2 months showed greater improvement in the F&S!,"[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health.'}]",The Gerontologist,['10.1093/geront/gny146']
480,32242289,LINKS Training and Unit Support for Mental Health: a Group-randomized Effectiveness Trial.,"The LINKS curriculum, adapted from Britt et al. (2018a), was designed to improve unit climate, knowledge, and attitudes about mental health treatment seeking in military personnel. The present study extends this research by examining implementation options, comparing the effectiveness of LINKS to an active control condition with training delivered by non-experts and comparing modules that varied in training length. Eight Army platoons were randomly assigned to one of four conditions: (1) 1-h Active Control, (2) 2-h Active Control, (3) 1-h LINKS, or (4) 2-h LINKS. Two platoons were assigned to each condition. Surveys were administered at pre-training (T1), post-training (T2), and 3 months later (T3). Eighty-four participants completed all study phases. Regardless of training content, participants receiving the 2-h modules reported greater training acceptability than those receiving the 1-h modules. At T3, participants in the LINKS conditions reported more mental health knowledge than participants in the Active Control conditions. Sustained effects were also observed on a number of treatment barriers and facilitators, with the LINKS conditions generally leading to better outcomes. At T3, 2-h LINKS condition participants reported receiving more mental health treatment relative to the other conditions. Findings suggest that LINKS can be effectively delivered by non-expert trainers, is a viable intervention for targeting mental health treatment-seeking, and is optimally packaged in a 2-h module. The training might benefit from additional leadership training efforts.",2020,"Findings suggest that LINKS can be effectively delivered by non-expert trainers, is a viable intervention for targeting mental health treatment-seeking, and is optimally packaged in a 2-h module.","['Eight Army platoons', 'Eighty-four participants completed all study phases']","['Active Control, (2) 2-h Active Control, (3) 1-h LINKS, or (4) 2-h LINKS']","['mental health knowledge', 'training acceptability', 'unit climate, knowledge, and attitudes about mental health treatment seeking']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0700308', 'cui_str': 'Protium'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]",84.0,0.041514,"Findings suggest that LINKS can be effectively delivered by non-expert trainers, is a viable intervention for targeting mental health treatment-seeking, and is optimally packaged in a 2-h module.","[{'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Start', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Amiya', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'Dixon', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Britt', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Toblin', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Adler', 'Affiliation': 'Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, 20910, USA. amy.b.adler.civ@mail.mil.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01106-6']
481,32235475,The Effect of Monophasic Pulsed Current with Stretching Exercise on the Heel Pain and Plantar Fascia Thickness in Plantar Fasciitis: A Randomized Controlled Trial.,"Plantar fasciitis (PF) is one of the most common causes of heel and foot pain. Monophasic pulsed current (MPC) is an electrical stimulation used to accelerate the healing processes. The purpose of this study was to determine the effect of MPC and MPC combined with plantar fascia stretching exercises (SE) on heel pain and plantar fascia thickness in treatment of PF and see if there is any relationship between heel pain and plantar fascia thickness after intervention. Forty-four participants diagnosed with PF were randomly assigned to two group; MPC group or MPC combined with plantar fascia SE. Plantar fascia thickness was measured with musculoskeletal ultrasound. Although no statistical differences between the two groups were found, heel pain and the plantar fascia thickness significantly decreased in both groups after the intervention ( p  < 0.001). No significant correlation was found between changes in heel pain and plantar fascia thickness after 4 weeks of treatment. Our results indicated that MPC can reduce heel pain and plantar fascia thickness caused by PF. However, MPC combined with plantar fascia SE is not superior to MCP only in terms of reduction in heel pain and plantar fascia thickening.",2020,"Although no statistical differences between the two groups were found, heel pain and the plantar fascia thickness significantly decreased in both groups after the intervention ( p  < 0.001).","['Forty-four participants diagnosed with PF', 'Plantar Fasciitis']","['MPC and MPC combined with plantar fascia stretching exercises (SE', 'Monophasic Pulsed Current with Stretching Exercise', 'MCP', 'MPC group or MPC combined with plantar fascia SE', 'MPC', 'Monophasic pulsed current (MPC']","['heel pain and plantar fascia thickness', 'Plantar fascia thickness', 'Heel Pain and Plantar Fascia Thickness', 'heel pain and plantar fascia thickening', 'heel pain and the plantar fascia thickness']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}]","[{'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0231780', 'cui_str': 'Heel pain'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}]",44.0,0.0429609,"Although no statistical differences between the two groups were found, heel pain and the plantar fascia thickness significantly decreased in both groups after the intervention ( p  < 0.001).","[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Physical Therapy, Loma Linda University, Loma Linda, CA 92354, USA.'}, {'ForeName': 'Jerrold', 'Initials': 'J', 'LastName': 'Petrofsky', 'Affiliation': 'School of Physical Therapy, Touro University, Henderson, NV 89014, USA.'}, {'ForeName': 'Noha S', 'Initials': 'NS', 'LastName': 'Daher', 'Affiliation': 'School of Allied Health Professions, Loma Linda University, Loma Linda, CA 92354, USA.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Lohman', 'Affiliation': 'Department of Physical Therapy, Loma Linda University, Loma Linda, CA 92354, USA.'}, {'ForeName': 'Hasan M', 'Initials': 'HM', 'LastName': 'Syed', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, Loma Linda University, Loma Linda, CA 92354, USA.'}, {'ForeName': 'Haneul', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon 21936, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020079']
482,32167723,Editorial Comment: Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib: The SURTIME Randomized Clinical Trial.,,2020,,['Patients With Synchronous Metastatic Renal Cell Carcinoma'],"['Sunitinib', 'Immediate vs Deferred Cytoreductive Nephrectomy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}]",[],,0.0689377,,"[{'ForeName': 'Stênio C', 'Initials': 'SC', 'LastName': 'Zequi', 'Affiliation': 'A. C. Camargo Cancer Center, Fundação Prudente, São Paulo, SP, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.03.12']
483,31257430,Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial.,"BACKGROUND


Preterm constitutes a major part of neonatal mortality, particularly in India. Due to dermal immaturity, preterm neonates are susceptible to various complications like infection, hypothermia, etc. Emollient application is a traditional practice in our subcontinent.
AIMS


To find out the efficacy of coconut oil application for skin maturity, prevention of sepsis, hypothermia and apnea, its effect on long-term neurodevelopment and adverse effect of it, if any.
MATERIAL AND METHODS


A randomized controlled trial was conducted in the rural field practice area of Department of Community Medicine, Burdwan Medical College from March 2014 to August 2018. Preterm born in the study period was divided into Group A (received virgin coconut oil application) and Group B (received body massage without any application). Neonatal skin condition was assessed on 7th, 14th, 21st and 28th day of life. Neurodevelopmental status was assessed on 3rd, 6th and 12th months.
RESULTS


A total of 2294 preterm were included in the study. Groups A and B consisted of 1146 and 1148 preterm infants, consecutively. Mean gestational age of the study population was 31.9 ± 3.4 weeks and 50.4% were male. Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application.
CONCLUSION


Use of coconut oil helps in dermal maturity and better neurodevelopmental outcome. Further studies are warranted for universal recommendation.",2020,"Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application.
","['rural field practice area of Department of Community Medicine, Burdwan Medical College from March 2014 to August 2018', 'Groups A and B consisted of 1146 and 1148 preterm infants, consecutively', 'Preterm Newborns', 'Mean gestational age of the study population was 31.9\u2009±\u20093.4\u2009weeks and 50.4% were male', 'A total of 2294 preterm were included in the study']","['Virgin Coconut Oil Application', 'coconut oil application', 'coconut oil', 'virgin coconut oil application) and Group B (received body massage without any application']","['Neurodevelopmental status', 'dermal maturity and better neurodevelopmental outcome', 'Mean weight loss', 'Neonatal skin condition', 'hypothermia and apnea, and better skin maturity and neurodevelopmental outcome', 'mean weight gain', 'adverse effect']","[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0009473', 'cui_str': 'Community Medicine'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0056060', 'cui_str': 'Coconut Oil'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0556844', 'cui_str': 'Body massage (regime/therapy)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",2294.0,0.067879,"Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application.
","[{'ForeName': 'Mithun Chandra', 'Initials': 'MC', 'LastName': 'Konar', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}, {'ForeName': 'Kamirul', 'Initials': 'K', 'LastName': 'Islam', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}, {'ForeName': 'Taraknath', 'Initials': 'T', 'LastName': 'Ghosh', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz041']
484,31741073,Single Dose Steroid Injection After Loss of Signal (LOS) During Thyroid Surgery is Effective to Recover Electric Signal Avoiding Vocal Cord Palsy and the Need of Staged Thyroidectomy: Prospective Evaluation on 702 Patients.,"BACKGROUND


Steroids are often used for the management of vocal cord palsy after thyroid surgery. There are no reports in the current literature of their intraoperative use, immediately after a loss of signal during neuromonitoring (LOS). We evaluate the impact of a single dose of 4 mg of dexamethasone on laryngeal nerve function, administrated at the time of a LOS during a nerve-monitored thyroidectomy.
METHODS


A prospective not randomized study was performed, dividing patients in two groups, when a LOS was detected. LOS was defined as an electromyographic signal (EMG) inferior to 100 μV when stimulating the inferior laryngeal nerve, according to international guidelines. In group 1 (G1), surgeon waits for signal's recovery up to 20 min. Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy. In group 2 (G2), 4 mg of dexamethasone were injected within 10 min from a detected LOS, waiting 10 min for its effects. An EMG value > to 200 μV within 20' after steroid administration was predictive of full recovery and normal post-operatory vocal cord function. Vocal cords motility was checked at postoperative day 1 in all patients by an experienced ENT.
RESULTS


Between January 2017 and December 2018, 702 patients underwent thyroid surgery under intermittent intraoperative nerve monitoring by two expert surgeons. A LOS was found in 22 patients in G1 and 16 in G2. Four patients in G1 spontaneously recovered electric signal (18.2%), while in G2 a signal was recovered in 14/16 patients (87.5%) (p < 0.001). This immediate effect was monitored by EMG, showing the increase in potentials at 10, 15 and 20 min after injection. ENT evaluation found vocal cord palsy, respectively, in 18/22 and 1/16 patients (G1 vs G2, p < 0.001). One of the patients in G2 who recovered electric signal presented transient palsy, fully recovered at 2 months, while the two patients who had a signal < 200 μV did not present postoperative cord palsy. In G1, 10/18 palsy were definitive. No permanent palsies were presents in G2.
CONCLUSION


A single 4 mg iv dexamethasone injection within 10 min form a LOS during thyroid surgery exerts a therapeutic action, measurable by EMG modifications. It avoids vocal nerve palsy and the need of a staged thyroidectomy. It may also protect from permanent cord palsy, but the mechanism is unknown.",2020,Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy.,"['Between January 2017 and December 2018, 702 patients underwent thyroid surgery under intermittent intraoperative nerve monitoring by two expert surgeons', '702 Patients', 'vocal cord palsy after thyroid surgery', '22 patients in G1 and 16 in G2']","['Steroid Injection', 'Staged Thyroidectomy', 'dexamethasone', 'Signal (LOS']","['LOS', 'Vocal cords motility', 'electric signal', 'vocal cord palsy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0042928', 'cui_str': 'Total Vocal Cord Paralysis'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0042928', 'cui_str': 'Total Vocal Cord Paralysis'}]",702.0,0.0914179,Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy.,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Donatini', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France. Giacko76@hotmail.com.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Danion', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zerrweck', 'Affiliation': 'ABC Hospital, Mexico City, Mexico.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Etienne', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Lacoste', 'Affiliation': 'Department of Anesthesia CHU Poitiers, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Kraimps', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}]",World journal of surgery,['10.1007/s00268-019-05295-2']
485,32205375,Protocol for a feasibility study of OnTrack: a digital system for upper limb rehabilitation after stroke.,"INTRODUCTION


Arm weakness is a common problem after stroke (affecting 450 000 people in the UK) leading to loss of independence. Repetitive activity is critical for recovery but research shows people struggle with knowing what or how much to do, and keeping track of progress. Working with more than 100 therapists (occupational therapists and physiotherapists) and patients with stroke, we codeveloped the OnTrack intervention-consisting of software for smart devices and coaching support-that has the potential to address this problem. This is a protocol to assess the feasibility of OnTrack for evaluation in a randomised control trial.
METHODS AND ANALYSIS


A mixed-method, single-arm study design will be used to evaluate the feasibility of OnTrack for hospital and community use. A minimum sample of 12 participants from a stroke unit will be involved in the study for 14 weeks. During week 1, 8 and 14 participants will complete assessments relating to their arm function, arm impairment and activation. During weeks 2-13, participants will use OnTrack to track their arm movement in real time, receive motivational messages and face-to-face sessions to address problems, gain feedback on activity and receive self-management skills coaching. All equipment will be loaned to study participants. A parallel process evaluation will be conducted to assess the intervention's fidelity, dose and reach, using a mixed-method approach. A public and patient involvement group will oversee the study and help with interpretation and dissemination of qualitative and quantitative data findings.
ETHICS AND DISSEMINATION


Ethical approval granted by the National Health Service Health Research Authority, Health and Care Research Wales, and the London-Surrey Research Ethics Committee (ref. 19/LO/0881). Trial results will be submitted for publication in peer review journals, presented at international conferences and disseminated among stroke communities. The results of this trial will inform development of a definitive trial.
TRIAL REGISTRATION NUMBER


NCT03944486.",2020,"INTRODUCTION


Arm weakness is a common problem after stroke (affecting 450 000 people in the UK) leading to loss of independence.","['upper limb rehabilitation after stroke', '100 therapists (occupational therapists and physiotherapists) and patients with stroke', '12 participants from a stroke unit will be involved in the study for 14 weeks']","['OnTrack to track their arm movement in real time, receive motivational messages and face-to-face sessions to address problems, gain feedback on activity and receive self-management skills coaching', 'OnTrack']",[],"[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]",[],12.0,0.144162,"INTRODUCTION


Arm weakness is a common problem after stroke (affecting 450 000 people in the UK) leading to loss of independence.","[{'ForeName': 'Gianpaolo', 'Initials': 'G', 'LastName': 'Fusari', 'Affiliation': 'Helix Centre, Royal College of Art, London, UK gianpaolo@helixcentre.com.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Gibbs', 'Affiliation': 'Helix Centre, Imperial College London, London, UK.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Hoskin', 'Affiliation': 'Helix Centre, Imperial College London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickens', 'Affiliation': 'Helix Centre, Imperial College London, London, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Leis', 'Affiliation': 'Big Data and Analytical Unit, Institute of Global Health Innovation, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Taylor', 'Affiliation': ""Faculty of Health Social Care and Education, Kingston and St George's University of London, London, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Jones', 'Affiliation': ""Faculty of Health Social Care and Education, Kingston and St George's University of London, London, UK.""}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': 'Helix Centre, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034936']
486,32240035,Transanal Versus Laparoscopic Total Mesorectal Excision: A Comparative Prospective Clinical Trial from Two Centers.,"Purpose:  Laparoscopic total mesorectal excision (LapTME) faced many obstacles in obese male with narrow pelvis and bulky mesorectum with increased risk of incomplete mesorectal excision and positive circumferential resection margin (CRM) and distal resection margin (DRM). Transanal total mesorectal excision (TaTME) is reported to result in a better quality total mesorectal excision (TME) specimen, lower incidence of CRM and DRM involvement, and higher rates of sphincter preservation. To date, there is still a debate about the feasibility and efficacy of transanal versus the laparoscopic approach for TME in middle and low rectal cancer.  Materials and Methods:  This is a prospective controlled clinical trial where 38 patients of middle or low rectal cancer from two tertiary centers were nonrandomly assigned to either TaTME or LapTME.  Results:  Eighteen patients were operated by TaTME versus 20 patients by LapTME. Mean body mass index was significantly higher in the TaTME group (30.74 ± 7.79) than in the LapTME group (25.99 ± 4.68) ( P  = .03). TaTME was associated with more transanal specimen extraction (55.5% versus 20%,  P  = .06). No significant differences were detected in CRM, DRM, peri- or postoperative complications, or conversion rates with more reported Clavien-Dindo grade III complications in the TaTME group ( P  = .29).  Conclusions:  TaTME facilitated rectal cancer surgery in obese patients and increased the chance of transanal specimen extraction with equivalent oncological outcomes to conventional LapTME. Further studies are recommended to build better evidence.",2020,"TaTME was associated with more transanal specimen extraction (55.5% versus 20%,  P  = .06).","['Eighteen patients were operated by TaTME versus 20 patients by LapTME', 'obese male with narrow pelvis and bulky mesorectum with increased risk of incomplete mesorectal excision and positive circumferential resection margin (CRM) and distal resection margin (DRM', 'obese patients', '38 patients of middle or low rectal cancer from two tertiary centers']","['TaTME or LapTME', 'TaTME', 'Laparoscopic total mesorectal excision (LapTME', 'Transanal Versus Laparoscopic Total Mesorectal Excision', 'Transanal total mesorectal excision (TaTME']","['Mean body mass index', 'transanal specimen extraction', 'CRM, DRM, peri- or postoperative complications, or conversion rates with more reported Clavien-Dindo grade III complications']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0447562', 'cui_str': 'Mesorectum'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}, {'cui': 'C1832370', 'cui_str': 'Desmin-related myofibrillar myopathy'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1832370', 'cui_str': 'Desmin-related myofibrillar myopathy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",38.0,0.0646891,"TaTME was associated with more transanal specimen extraction (55.5% versus 20%,  P  = .06).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Zuhdy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Elmore', 'Affiliation': 'Department of Gastrointestinal Surgery, IRCCS San Raffaele, University Vita e Salute, Milan, Italy.'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Shams', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Mohamed A F', 'Initials': 'MAF', 'LastName': 'Hegazy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Roshdy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Eldamshety', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Islam H', 'Initials': 'IH', 'LastName': 'Metwally', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Rosati', 'Affiliation': 'Department of Gastrointestinal Surgery, IRCCS San Raffaele, University Vita e Salute, Milan, Italy.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0828']
487,32238297,Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits.,"OBJECTIVE


To test the acceptability and effectiveness of a lay-coach-facilitated, videoconferenced, short-term behavioral activation (Tele-BA) intervention for improving social connectedness among homebound older adults.
METHODS


We employed a two-site, participant-randomized controlled trial with 89 older adults (averaging 74 years old) who were recipients of, and initially screened by, home-delivered meals programs. All participants reported loneliness; many reported being socially isolated and/or dissatisfaction with social support. Participants received five weekly videoconference sessions of either Tele-BA or Tele-FV (friendly visits; active control). Three primary outcomes were social interaction (Duke Social Support Index [DSSI] Social Interaction Subscale), subjective loneliness (PROMIS Social Isolation Scale), and DSSI Satisfaction with Social Support Subscale. Depression severity (PHQ-9) and disability (WHODAS 2.0) were secondary outcomes. Mixed-effects regression models were fit to evaluate outcomes at 6- and 12-weeks follow-up.
RESULTS


Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025).
CONCLUSION


A short-term, lay-coach-facilitated Tele-BA is a promising intervention for the growing numbers of homebound older adults lacking social connectedness. The intervention holds promise for scalability in programs that already serve homebound older adults. More research is needed to solidify the clinical evidence base, cost-effectiveness and sustainability of Tele-BA delivered by lay coaches for homebound and other older adults.",2020,"Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025).
","['89 older adults (averaging 74 years old) who were recipients of, and initially screened by, home-delivered meals programs', 'homebound older adults', 'Homebound Older Adults']","['lay-coach-facilitated, videoconferenced, short-term behavioral activation (Tele-BA) intervention', 'videoconference sessions of either Tele-BA or Tele-FV (friendly visits; active control', 'Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits', 'lay-coach-facilitated Tele-BA']","['Depression severity (PHQ-9) and disability', 'depression', 'social interaction (Duke Social Support Index [DSSI] Social Interaction Subscale), subjective loneliness (PROMIS Social Isolation Scale), and DSSI Satisfaction with Social Support Subscale', 'disability', 'loneliness', 'satisfaction with social support', 'social interaction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",89.0,0.0496621,"Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025).
","[{'ForeName': 'Namkee G', 'Initials': 'NG', 'LastName': 'Choi', 'Affiliation': 'The University of Texas at Austin, Steve Hicks School of Social Work (NGC, CNM), Austin, TX. Electronic address: nchoi@austin.utexas.edu.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Pepin', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'The University of Texas at Austin, Steve Hicks School of Social Work (NGC, CNM), Austin, TX.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.008']
488,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
489,32032087,Can an Integrative Care Approach Improve Physical Function Trajectories after Orthopaedic Trauma? A Randomized Controlled Trial.,"BACKGROUND


Orthopaedic trauma patients frequently experience mobility impairment, fear-related issues, self-care difficulties, and work-related disability []. Recovery from trauma-related injuries is dependent upon injury severity as well as psychosocial factors []. However, traditional treatments do not integrate psychosocial and early mobilization to promote improved function, and they fail to provide a satisfying patient experience.
QUESTIONS/PURPOSES


We sought to determine (1) whether an early psychosocial intervention (integrative care with movement) among patients with orthopaedic trauma improved objective physical function outcomes during recovery compared with usual care, and (2) whether an integrative care approach with orthopaedic trauma patients improved patient-reported physical function outcomes during recovery compared with usual care.
METHODS


Between November 2015 and February 2017, 1133 patients were admitted to one hospital as orthopaedic trauma alerts to the care of the three orthopaedic trauma surgeons involved in the study. Patients with severe or multiple orthopaedic trauma requiring one or more surgical procedures were identified by our orthopaedic trauma surgeons and approached by study staff for enrollment in the study. Patients were between 18 years and 85 years of age. We excluded individuals outside of the age range; those with diagnosis of a traumatic brain injury []; those who were unable to communicate effectively (for example, at a level where self-report measures could not be answered completely); patients currently using psychotropic medications; or those who had psychotic, suicidal, or homicidal ideations at time of study enrollment. A total of 112 orthopaedic trauma patients were randomized to treatment groups (integrative and usual care), with 13 withdrawn (n = 99; 58% men; mean age 44 years ± 17 years). Data was collected at the following time points: baseline (acute hospitalization), 6 weeks, 3 months, 6 months, and at 1 year. By 1-year follow-up, we had a 75% loss to follow-up. Because our data showed no difference in the trajectories of these outcomes during the first few months of recovery, it is highly unlikely that any differences would appear months after 6 months. Therefore, analyses are presented for the 6-month follow-up time window. Integrative care consisted of usual trauma care plus additional resources, connections to services, as well as psychosocial and movement strategies to help patients recover. Physical function was measured objectively (handgrip strength, active joint ROM, and Lower Extremity Gain Scale) and subjectively (Patient-Reported Outcomes Measurement Information System-Physical Function [PROMIS®-PF] and Tampa Scale of Kinesiophobia). Higher values for hand grip, Lower Extremity Gain Scale (score range 0-27), and PROMIS®-PF (population norm = 50) are indicative of higher functional ability. Lower Tampa Scale of Kinesiophobia (score range 11-44) scores indicate less fear of movement. Trajectories of these measures were determined across time points.
RESULTS


We found no differences at 6 months follow-up between usual care and integrative care in terms of handgrip strength (right handgrip strength β = -0.0792 [95% confidence interval -0.292 to 0.133]; p = 0.46; left handgrip strength β = -0.133 [95% CI -0.384 to 0.119]; p = 0.30), or Lower Extremity Gain Scale score (β = -0.0303 [95% CI -0.191 to 0.131]; p = 0.71). The only differences between usual care and integrative care in active ROM achieved by final follow-up within the involved extremity was noted in elbow flexion, with usual care group 20° ± 10° less than integrative care (t [27] = -2.06; p = 0.05). Patients treated with usual care and integrative care showed the same Tampa Scale of Kinesiophobia score trajectories (β = 0.0155 [95% CI -0.123 to 0.154]; p = 0.83).
CONCLUSION


Our early psychosocial intervention did not change the trajectory of physical function recovery compared with usual care. Although this specific intervention did not alter recovery trajectories, these interventions should not be abandoned because the greatest gains in function occur early in recovery after trauma, which is the key time in transition to home. More work is needed to identify ways to capitalize on improvements earlier within the recovery process to facilitate functional gains and combat psychosocial barriers to recovery.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,We found no differences at 6 months follow-up between usual care and integrative care in terms of handgrip strength (right handgrip strength β,"['112 orthopaedic trauma patients were randomized to treatment groups (integrative and usual care), with 13 withdrawn (n = 99; 58% men; mean age 44 years ± 17 years', 'patients with orthopaedic trauma', 'Patients were between 18 years and 85 years of age', '1133 patients were admitted to one hospital as orthopaedic trauma alerts to the care of the three orthopaedic trauma surgeons involved in the study', 'individuals outside of the age range; those with diagnosis of a traumatic brain injury [28]; those who were unable to communicate effectively (for example, at a level where self-report measures could not be answered completely); patients currently using psychotropic medications; or those who had psychotic, suicidal, or homicidal ideations at time of study enrollment', 'Between November 2015 and February 2017', 'Patients with severe or multiple orthopaedic trauma requiring one or more surgical procedures were identified by our orthopaedic trauma surgeons and approached by study staff for enrollment in the study']",['early psychosocial intervention (integrative care with movement'],"['Physical Function Trajectories', 'objective physical function outcomes', 'Higher values for hand grip, Lower Extremity Gain Scale', 'same Tampa Scale of Kinesiophobia score trajectories', 'handgrip strength (right handgrip strength β', 'objectively (handgrip strength, active joint ROM, and Lower Extremity Gain Scale) and subjectively (Patient-Reported Outcomes Measurement Information System-Physical Function [PROMIS®-PF] and Tampa Scale of Kinesiophobia', 'Lower Extremity Gain Scale score', 'Lower Tampa Scale of Kinesiophobia (score range 11-44) scores indicate less fear of movement', 'Physical function', 'active ROM', 'PROMIS®-PF']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0586908', 'cui_str': 'Trauma surgeon (occupation)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0566000', 'cui_str': 'Unable to communicate (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0455204', 'cui_str': 'Homicidal thoughts (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",1133.0,0.0714295,We found no differences at 6 months follow-up between usual care and integrative care in terms of handgrip strength (right handgrip strength β,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zdziarski-Horodyski', 'Affiliation': 'L. Zdziarski-Horodyski, T. Vasilopoulos, MB. Horodyski, J. E. Hagen, K. H. Sadasivan, S. Sharififar, M. Patrick, H. K. Vincent, Department of Orthopaedics and Rehabilitation, University of Florida, Gainesville, FL, USA L. Zdziarski-Horodyski, Department of Orthopaedics and Sports Medicine, University of Utah, Salt Lake City, UT, USA T. Vasilopoulos, Department of Anesthesia, University of Florida, Gainesville, FL, USA R. Guenther, Department of Clinical Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Vasilopoulos', 'Affiliation': ''}, {'ForeName': 'MaryBeth', 'Initials': 'M', 'LastName': 'Horodyski', 'Affiliation': ''}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Hagen', 'Affiliation': ''}, {'ForeName': 'Kalia S', 'Initials': 'KS', 'LastName': 'Sadasivan', 'Affiliation': ''}, {'ForeName': 'Sharareh', 'Initials': 'S', 'LastName': 'Sharififar', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Patrick', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Guenther', 'Affiliation': ''}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Vincent', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001140']
490,32039956,Reply to the Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.0971855,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001164']
491,30817251,Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer.,"PURPOSE


PROSTVAC, a viral vector-based immunotherapy, prolonged median overall survival (OS) by 8.5 months versus placebo in metastatic castration-resistant prostate cancer in a phase II study. This phase III study further investigated those findings.
PATIENTS AND METHODS


Patients were randomly assigned to PROSTVAC (Arm V; n = 432), PROSTVAC plus granulocyte-macrophage colony-stimulating factor (Arm VG; n = 432), or placebo (Arm P; n = 433), stratified by prostate-specific antigen (less than 50 ng/mL  v  50 ng/mL or more) and lactate dehydrogenase (less than 200  v  200 U/L or more). Primary end point was OS. Secondary end points were patients alive without events (AWE)-namely, radiographic progression, pain progression, chemotherapy initiation, or death-at 6 months and safety. The study design was a superiority trial of PROSTVAC (Arm V or Arm VG) versus Arm P. Three interim analyses were planned.
RESULTS


At the third interim analysis, criteria for futility were met and the trial was stopped early. Neither active treatment had an effect on median OS (Arm V, 34.4 months; hazard ratio, 1.01; 95% CI, 0.84 to 1.20;  P  = .47; Arm VG, 33.2 months; hazard ratio, 1.02; 95% CI, 0.86 to 1.22;  P  = .59; Arm P, 34.3 months). Likewise, AWE at 6 months was similar (Arm V, 29.4%; odds ratio, 0.96; 95% CI, 0.71 to 1.29; Arm VG, 28.0%; odds ratio, 0.89; 95% CI, 0.66 to 1.20; placebo, 30.3%). Adverse events were similar for the treatment and placebo groups, with the most common being injection site reactions (62% to 72%) and fatigue (21% to 24%). Arrhythmias were the most common cardiac-related events (1.4% to 3.5%). There were no reports of either myocarditis or pericarditis. Serious treatment-related events occurred in less than 1% of all patients.
CONCLUSION


Whereas PROSTVAC was safe and well tolerated, it had no effect on OS or AWE in metastatic castration-resistant prostate cancer. Combination therapy is currently being explored in clinical trials.",2019,"Whereas PROSTVAC was safe and well tolerated, it had no effect on OS or AWE in metastatic castration-resistant prostate cancer.","['Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer', 'metastatic castration-resistant prostate cancer', 'Patients were randomly assigned to PROSTVAC (Arm V; n = 432']","['granulocyte-macrophage colony-stimulating factor (Arm VG; n = 432), or placebo', 'placebo', 'stratified by prostate-specific antigen (less than 50 ng/mL  v']","['lactate dehydrogenase', 'Adverse events', 'median overall survival (OS', 'fatigue', 'myocarditis or pericarditis', 'median OS', 'OS or AWE', 'patients alive without events (AWE)-namely, radiographic progression, pain progression, chemotherapy initiation, or death-at 6 months and safety']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1519903', 'cui_str': 'PROSTVAC-VF'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",433.0,0.376216,"Whereas PROSTVAC was safe and well tolerated, it had no effect on OS or AWE in metastatic castration-resistant prostate cancer.","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': '1 National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borre', 'Affiliation': '2 Aarhus Universitetshospital, Åarhus, Denmark.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': '3 Comprehensive Cancer Centers of Nevada, Las Vegas, NV.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': '4 St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': '5 University of Utah Huntsman Cancer Institute, Salt Lake City, UT.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': '6 Royal Marsden Hospital, Sutton, United Kingdom.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Pook', 'Affiliation': '7 Monash Medical Centre, Bentleigh, Victoria, Australia.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Rathenborg', 'Affiliation': '8 Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Flaig', 'Affiliation': '9 University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Carles', 'Affiliation': ""10 Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""11 Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.""}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': '12 Carolina Urologic Research Center, Myrtle Beach, SC.'}, {'ForeName': 'Liddy', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': '13 Bavarian Nordic, Morrisville, NC.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Heery', 'Affiliation': '13 Bavarian Nordic, Morrisville, NC.'}, {'ForeName': 'Winald R', 'Initials': 'WR', 'LastName': 'Gerritsen', 'Affiliation': '14 Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Priou', 'Affiliation': '15 Centre Hospitalier Départemental, La Roche sur Yon, France.'}, {'ForeName': 'Niels C', 'Initials': 'NC', 'LastName': 'Langkilde', 'Affiliation': '16 Aalborg Universitethospital, Aalborg, Denmark.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Novikov', 'Affiliation': '17 North-Western State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': '18 Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02031']
492,31806133,Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure.,"BACKGROUND


Moderate and moderately severe renal impairment are common in patients with heart failure and reduced ejection fraction, but whether beta-blockers are effective is unclear, leading to underuse of life-saving therapy.
OBJECTIVES


This study sought to investigate patient prognosis and the efficacy of beta-blockers according to renal function using estimated glomerular filtration rate (eGFR).
METHODS


Analysis of 16,740 individual patients with left ventricular ejection fraction <50% from 10 double-blind, placebo-controlled trials was performed. The authors report all-cause mortality on an intention-to-treat basis, adjusted for baseline covariates and stratified by heart rhythm.
RESULTS


Median eGFR at baseline was 63 (interquartile range: 50 to 77) ml/min/1.73 m 2 ; 4,584 patients (27.4%) had eGFR 45 to 59 ml/min/1.73 m 2 , and 2,286 (13.7%) 30 to 44 ml/min/1.73 m 2 . Over a median follow-up of 1.3 years, eGFR was independently associated with mortality, with a 12% higher risk of death for every 10 ml/min/1.73 m 2  lower eGFR (95% confidence interval [CI]: 10% to 15%; p < 0.001). In 13,861 patients in sinus rhythm, beta-blockers reduced mortality versus placebo; adjusted hazard ratio (HR): 0.73 for eGFR 45 to 59 ml/min/1.73 m 2  (95% CI: 0.62 to 0.86; p < 0.001) and 0.71 for eGFR 30 to 44 ml/min/1.73 m 2  (95% CI: 0.58 to 0.87; p = 0.001). The authors observed no deterioration in renal function over time in patients with moderate or moderately severe renal impairment, no difference in adverse events comparing beta-blockers with placebo, and higher mortality in patients with worsening renal function on follow-up. Due to exclusion criteria, there were insufficient patients with severe renal dysfunction (eGFR <30 ml/min/1.73 m 2 ) to draw conclusions. In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
CONCLUSIONS


Patients with heart failure, left ventricular ejection fraction <50% and sinus rhythm should receive beta-blocker therapy even with moderate or moderately severe renal dysfunction.",2019,"In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
","['16,740 individual patients with left ventricular ejection fraction\xa0<50% from 10 double-blind', 'm 2 ; 4,584 patients (27.4%) had eGFR 45 to 59\xa0ml', 'Patients with heart failure, left ventricular ejection fraction\xa0<50% and sinus rhythm', 'patients with heart failure and reduced ejection fraction', '2,879 patients with atrial fibrillation', 'Patients', 'patients with severe renal dysfunction (eGFR\xa0<30']","['beta-blockers', 'placebo']","['adverse events', 'severe renal dysfunction', 'renal function', 'risk of death', 'Beta-Blocker Efficacy', 'glomerular filtration rate (eGFR', 'mortality with beta-blockers']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",2879.0,0.289216,"In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
","[{'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Kotecha', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom; Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia. Electronic address: d.kotecha@bham.ac.uk.'}, {'ForeName': 'Simrat K', 'Initials': 'SK', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Flather', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Science, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Rosano', 'Affiliation': 'Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Kardiologie, Angiologie und Internistische Intensivmedizin, Universitatsklinikum des Saarlandes, Homburg/Saar, Germany.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wikstrand', 'Affiliation': 'Wallenberg Laboratory for Cardiovascular Research, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology, Charite Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Centre Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manzano', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Ramón y Cajal, Universidad de Alcalá (IRYCIS), Plaza de San Diego, Madrid, Spain.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'von Lueder', 'Affiliation': 'Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia; Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rigby', 'Affiliation': 'Hull York Medical School, Faculty of Health Sciences, University of Hull, Kingston-upon-Hull, United Kingdom.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Andersson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital and Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kjekshus', 'Affiliation': 'Rikshospitalet University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wedel', 'Affiliation': 'Health Metrics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Klinik fur Kardiologie, UniversitätsSpital Zürich, Zürich, Switzerland.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Damman', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Centre Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Redon', 'Affiliation': 'INCLIVA Biomedical Research Institute, Valencia, Spain.'}, {'ForeName': 'Andrew J S', 'Initials': 'AJS', 'LastName': 'Coats', 'Affiliation': 'Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.059']
493,32236522,The Effects of Mat Pilates Training on Vascular Function and Body Fatness in Obese Young Women With Elevated Blood Pressure.,"BACKGROUND


Effective nonpharmacological interventions targeting the enhancement of vascular function and decline of body fatness (BF) in obese individuals are indispensable for the prevention of hypertension and cardiovascular events in young adults. Mat Pilates training (MPT) has gained significant popularity worldwide, yet its effects on vascular function and body composition are understudied. We examined the effects of MPT on vascular function and BF in young obese women with elevated blood pressure (BP).
METHODS


Twenty-eight young obese women with elevated BP were randomized to an MPT (n = 14) or a nonexercising control (CON, n = 14) group for 12 weeks. Systemic arterial stiffness (brachial-ankle pulse wave velocity (baPWV)), brachial and aortic BP, wave reflection (augmentation index (AIx)), plasma nitric oxide (NO) levels, and BF percentage (BF%) were assessed before and after 12 weeks.
RESULTS


MPT significantly reduced (P ˂ 0.05) baPWV (-0.7 ± 0.2 m/s), AIx (-4 ± 1%), brachial systolic BP (-5 ± 1 mm Hg), aortic systolic BP (-6 ± 1 mm Hg), and BF% (-2 ± 1%), while significantly increasing plasma NO (6 ± 2 µM) (P ˂ 0.05) compared with CON. MPT improved systemic arterial stiffness, aortic BP, wave reflection, circulating plasma NO, and BF% in young obese women with elevated BP.
CONCLUSIONS


MPT may be an effective intervention for the improvement of vascular function and BF in young obese women with elevated BP, a population at risk for hypertension and early vascular complications.
CLINICAL TRIALS REGISTRATION


Trial Number NCT03907384.",2020,"MPT improved systemic arterial stiffness, aortic BP, wave reflection, circulating plasma","['Twenty-eight young obese women with elevated BP', 'young obese women with elevated BP', 'obese individuals', 'young adults', 'young obese women with elevated blood pressure (BP', 'Obese Young Women With Elevated Blood Pressure']","['Mat Pilates Training', 'MPT', 'Mat Pilates training (MPT', 'nonexercising control (CON']","['Vascular Function and Body Fatness', 'Systemic arterial stiffness (brachial-ankle pulse wave velocity (baPWV)), brachial and aortic BP, wave reflection (augmentation index (AIx)), plasma nitric oxide (NO) levels, and BF percentage (BF', 'systemic arterial stiffness, aortic BP, wave reflection, circulating plasma', 'brachial systolic BP', 'vascular function and BF', 'aortic systolic BP']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",28.0,0.085763,"MPT improved systemic arterial stiffness, aortic BP, wave reflection, circulating plasma","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska-Omaha, Omaha, NE, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa026']
494,32229229,Effectiveness and Safety of Supervised Home-based Physical Training in Patients With COPD on Long-Term Home Oxygen Therapy: A Randomized Trial.,"BACKGROUND


Patients with COPD in advanced stages who need long-term home oxygen therapy (LTHOT) have difficulty participating in outpatient pulmonary rehabilitation (PR) programs. This difficulty is due to the severity of their disease, limitations involving transportation and mobility, high costs, and issues related to patients' safety and individual needs. Unsupervised home-based physical training (PT) is frequently used.
RESEARCH QUESTION


The main objective of this study was to investigate the effectiveness of a supervised home-based PT program on exercise capacity and other outcomes in patients with COPD receiving LTHOT.
STUDY DESIGN AND METHODS


In a randomized clinical trial, patients with COPD who were on LTHOT were allocated into two groups: the supervised physical training (PT) group, consisting of patients who received home-based supervised muscle strength and endurance training in twice-weekly 60-min sessions for 12 weeks; and the unsupervised activity booklet group, consisting of patients who received a booklet advising them to perform exercise twice a week for 12 weeks. All participants were assessed prior to and following the intervention in terms of exercise capacity (6-min step-test and the 1-min sit-to-stand test); dyspnea (Medical Research Council scale); fatigue (Brazilian Portuguese version of the Fatigue Severity Scale); and health status (COPD Assessment Test).
RESULTS


A total of 44 patients were assessed (mean age, 70 ± 8 years; FEV 1 , 33 ± 14% predicted) (PT group, n = 22; booklet group, n = 22). Only the PT group patients presented significant improvement in the 6-min step-test (21 ± 9 vs 14 ± 11; P = .001), Medical Research Council scale (3.3 ± 1.0 vs 3.9 ± 0.9; P = .013), Brazilian Portuguese version of the Fatigue Severity Scale (5.0 ± 1.4 vs 5.2 ± 1.3; P = .015), and COPD Assessment Test (21 ± 8 vs 26 ± 6; P = .001). No adverse effects were observed.
INTERPRETATION


Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue, and health status in patients with COPD on LTHOT.
CLINICAL TRIAL REGISTRATION


Brazilian Registry of Clinical Trials; No.: RBR-535smn; URL: http://www.ensaiosclinicos.gov.br.",2020,"Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue and health status in patients with COPD on LTHOT.","['44 patients were assessed (70±8 years, FEV 1 : 33±14%predicted) (PTG, n=22; BG, n=22', 'patients with COPD', 'patients with COPD on LTHOT', 'Patients with chronic obstructive pulmonary disease (COPD) in advanced disease stage who need long-term home oxygen therapy (LTHOT) have difficulty participating in outpatient pulmonary rehabilitation (PR) programs']","['supervised home-based PT program', 'THERAPY', 'supervised physical training group (PTG), consisting of patients who received home-based supervised muscle strength and endurance training in twice-weekly 60-minute sessions for 12 weeks; and unsupervised activity booklet group (BG), consisting of patients who received a booklet advising them to perform exercise', 'Unsupervised home-based physical training (PT']","['exercise capacity (6-Minute Step-Test (6MST) and the 1-Minute Sit-to-Stand Test [STST]); dyspnea (Medical Research Council scale [MRC]); fatigue (Fatigue Severity Scale [FSS-BR]); and health status (COPD Assessment Test [CAT', 'FSS-BR', 'adverse effects', 'MRC', 'exercise capacity, dyspnea, fatigue and health status', '6MST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy (procedure)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.0462586,"Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue and health status in patients with COPD on LTHOT.","[{'ForeName': 'Demetria', 'Initials': 'D', 'LastName': 'Kovelis', 'Affiliation': 'Department of Physical Therapy, UniDomBosco University, Curitiba, Paraná, Brazil. Electronic address: demetriakovelis@gmail.com.'}, {'ForeName': 'Anna R S', 'Initials': 'ARS', 'LastName': 'Gomes', 'Affiliation': 'Department of Prevention and Rehabilitation in Physical Therapy, Masters/Doctoral Program in Physical Education, Federal University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Mazzarin', 'Affiliation': 'Cajuru University Hospital, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Samia K', 'Initials': 'SK', 'LastName': 'Biazim', 'Affiliation': 'Cajuru University Hospital, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pitta', 'Affiliation': 'Department of Physical Therapy, State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Valderramas', 'Affiliation': 'Department of Prevention and Rehabilitation in Physical Therapy, Masters/Doctoral Program in Internal Medicine and Health Sciences, Federal University of Paraná, Curitiba, Paraná, Brazil.'}]",Chest,['10.1016/j.chest.2020.02.063']
495,32239210,Effect of Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy on Local Recurrence and Survival: Long-term Results From the TARGIT-A Randomized Clinical Trial in Early Breast Cancer.,"Importance


Conventional adjuvant radiotherapy for breast cancer given daily for several weeks is onerous and expensive. Some patients may be obliged to choose a mastectomy instead, and some may forgo radiotherapy altogether. We proposed a clinical trial to test whether radiotherapy could be safely limited to the tumor bed.
Objective


To determine whether delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT) is noninferior to whole-breast external beam radiotherapy (EBRT) in terms of local control.
Design, Setting, and Participants


In this prospective, randomized (1:1 ratio) noninferiority trial, 1153 patients aged 45 years or older with invasive ductal breast carcinoma smaller than 3.5 cm treated with breast conservation were enrolled from 28 centers in 9 countries. Data were locked in on July 3, 2019.
Interventions


The TARGIT-A trial was started in March 2000; patients were randomized after needle biopsy to receive TARGIT-IORT immediately after lumpectomy under the same anesthetic vs EBRT and results have been shown to be noninferior. A parallel study, described in this article, was initiated in 2004; patients who had their cancer excised were randomly allocated using separate randomization tables to receive EBRT or delayed TARGIT-IORT given as a second procedure by reopening the lumpectomy wound.
Main Outcomes and Measures


A noninferiority margin for local recurrence rate of 2.5% at 5 years, and long-term survival outcomes.
Results


Overall, 581 women (mean [SD] age, 63 [7] years) were randomized to delayed TARGIT-IORT and 572 patients (mean [SD] age, 63 [8] years) were randomized to EBRT. Sixty patients (5%) had tumors larger than 2 cm, or had positive nodes and only 32 (2.7%) were younger than 50 years. Delayed TARGIT-IORT was not noninferior to EBRT. The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%). With long-term follow-up (median [IQR], 9.0 [7.5-10.5] years), there was no statistically significant difference in local recurrence-free survival (HR, 0.75; 95% CI, 0.57-1.003; P = .052), mastectomy-free survival (HR, 0.88; 95% CI, 0.65-1.18; P = .38), distant disease-free survival (HR, 1.00; 95% CI, 0.72-1.39; P = .98), or overall survival (HR, 0.96; 95% CI, 0.68-1.35; P = .80).
Conclusions and Relevance


These long-term data show that despite an increase in the number of local recurrences with delayed TARGIT-IORT, there was no statistically significant decrease in mastectomy-free survival, distant disease-free survival, or overall survival.
Trial Registration


ISRCTN34086741, ClinicalTrials.gov Identifier: NCT00983684.",2020,"The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%).","['1153 patients aged 45 years or older with invasive ductal breast carcinoma smaller than 3.5 cm treated with breast conservation', 'Sixty patients (5%) had tumors larger than 2 cm, or had positive nodes and only 32 (2.7%) were younger than 50 years', 'Early Breast Cancer', '581 women (mean [SD] age, 63 [7] years', 'and 572 patients (mean [SD] age, 63 [8] years', '2004; patients who had their cancer excised']","['EBRT', 'radiotherapy', 'delayed TARGIT-IORT', 'Conventional adjuvant radiotherapy', 'EBRT or delayed TARGIT-IORT given as a second procedure by reopening the lumpectomy wound', 'delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT', 'Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy', 'needle biopsy to receive TARGIT-IORT', 'breast external beam radiotherapy (EBRT']","['mastectomy-free survival', 'Local Recurrence and Survival', 'distant disease-free survival', 'mastectomy-free survival, distant disease-free survival, or overall survival', 'local recurrence rates', 'local recurrence rate', 'number of local recurrences', 'local recurrence-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0005560', 'cui_str': 'Needle biopsy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",1153.0,0.381474,"The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%).","[{'ForeName': 'Jayant S', 'Initials': 'JS', 'LastName': 'Vaidya', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'University of Western Australia School of Surgery, West Australia, Australia.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Flyger', 'Affiliation': 'Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Tobias', 'Affiliation': 'Department of Clinical Oncology, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Corica', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, West Australia, Australia.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Massarut', 'Affiliation': 'Department of Surgery, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Wenz', 'Affiliation': 'University Medical Center Mannheim, Department of Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Pigorsch', 'Affiliation': 'Red Cross Hospital, Department of Gynecology and Obstetrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alvarado', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Douek', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Red Cross Hospital, Department of Gynecology and Obstetrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Potyka', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Patient Advocate and Writer, London, United Kingdom.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, Ninewells Hospital, Dundee, United Kingdom.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sperk', 'Affiliation': 'University Medical Center Mannheim, Department of Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Laws', 'Affiliation': 'Department of Surgery, Royal Hampshire County Hospital, Winchester, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sütterlin', 'Affiliation': 'University Medical Center Mannheim, Department of Gynecology and Obstetrics, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': ""Department of Oncology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'Helen Rey Breast Cancer Foundation, John Wayne Cancer Institute, University of Southern California, Los Angeles.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Vinante', 'Affiliation': 'Department of Radiation Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bozza', 'Affiliation': 'Instituto Oncologico Veneto, Padoa, Italy.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Pazos', 'Affiliation': 'University Hospital, Department of Radiation Oncology, Ludwig Maximilians Universitat, Munich, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Le Blanc-Onfroy', 'Affiliation': ""Oncologue radiothérapeute, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Brust Zentrum Seefeld, Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Polkowski', 'Affiliation': 'Department of Surgical Oncology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': 'Breast Center, Universitätsspital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Niewald', 'Affiliation': 'Saarland University Medical Center, Homberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blohmer', 'Affiliation': 'Sankt Gertrauden-Krankenhaus, and The Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCready', 'Affiliation': 'Princess Margaret Cancer Centre Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hoefer', 'Affiliation': 'Sentara Surgery Specialists, Hampton, Virginia.'}, {'ForeName': 'Pond', 'Initials': 'P', 'LastName': 'Kelemen', 'Affiliation': 'Ashikari Breast Center, New York Medical College, New York, New York.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Petralia', 'Affiliation': 'Department of Surgery, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Falzon', 'Affiliation': 'Department of Pathology, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baum', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, West Australia, Australia.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0249']
496,32239237,Long-term cost-effectiveness of screening for fracture risk in a UK primary care setting: the SCOOP study.,"Community-based screening and treatment of women aged 70-85 years at high fracture risk reduced fractures; moreover, the screening programme was cost-saving. The results support a case for a screening programme of fracture risk in older women in the UK.
INTRODUCTION


The SCOOP (screening for prevention of fractures in older women) randomized controlled trial investigated whether community-based screening could reduce fractures in women aged 70-85 years. The objective of this study was to estimate the long-term cost-effectiveness of screening for fracture risk in a UK primary care setting compared with usual management, based on the SCOOP study.
METHODS


A health economic Markov model was used to predict the life-time consequences in terms of costs and quality of life of the screening programme compared with the control arm. The model was populated with costs related to drugs, administration and screening intervention derived from the SCOOP study. Fracture risk reduction in the screening arm compared with the usual management arm was derived from SCOOP. Modelled fracture risk corresponded to the risk observed in SCOOP.
RESULTS


Screening of 1000 patients saved 9 hip fractures and 20 non-hip fractures over the remaining lifetime (mean 14 years) compared with usual management. In total, the screening arm saved costs (£286) and gained 0.015 QALYs/patient in comparison with usual management arm.
CONCLUSIONS


This analysis suggests that a screening programme of fracture risk in older women in the UK would gain quality of life and life years, and reduce fracture costs to more than offset the cost of running the programme.",2020,"In total, the screening arm saved costs (£286) and gained 0.015 QALYs/patient in comparison with usual management arm.
","['older women in the UK', '1000 patients saved 9 hip fractures and 20 non-hip fractures', 'older women', 'women aged 70-85\xa0years at high fracture risk reduced fractures', 'women aged 70-85\xa0years']","['SCOOP (screening', 'community-based screening']","['Modelled fracture risk', 'costs and quality of life', 'fracture costs', 'Fracture risk reduction']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0183177', 'cui_str': 'Scoop'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.0413955,"In total, the screening arm saved costs (£286) and gained 0.015 QALYs/patient in comparison with usual management arm.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Söreskog', 'Affiliation': 'Quantify Research, Stockholm, Sweden.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Borgström', 'Affiliation': 'Quantify Research, Stockholm, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Department of Rheumatology, University Hospitals Bristol, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Harvey', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Centre for Metabolic Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Marshall', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'T W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Redmond', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, Centre for Medicine, University of Leicester, Leicester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McCloskey', 'Affiliation': 'Centre for Metabolic Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Centre for Metabolic Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK. w.j.pontefract@shef.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05372-6']
497,31860328,Temporal Factors and Missed Doses of Tuberculosis Treatment. A Causal Associations Approach to Analyses of Digital Adherence Data.,"Rationale:  Tuberculosis treatment lasts for 6 months or more. Treatment adherence is critical; regimen length, among other factors, makes this challenging. Globally, analyses mapping common types of nonadherence are lacking. For example, is there a greater challenge resulting from early treatment cessation (discontinuation) or intermittent missed doses (suboptimal dosing implementation)? This is essential knowledge for the development of effective interventions and more ""forgiving"" regimens, as well as to direct national tuberculosis programs. Objectives:  To granularly describe how patients take their tuberculosis medication and the temporal factors associated with missed doses. Methods:  The present study included patients with pulmonary tuberculosis enrolled in the control arm of a pragmatic, cluster-randomized trial in China of electronic reminders to improve treatment adherence. Treatment was the standard 6-month course (180 d), dosed every other day (90 doses). Medication monitor boxes recorded adherence (box opening) without prompting reminders. Patterns of adherence were visualized and described. Mixed-effects logistic regression models examined the temporal factors associated with per-dose suboptimal dosing implementation, adjusting for clustering within a participant. Cox regression models were used to examine the association between early suboptimal dosing implementation and permanent discontinuation. Results:  Across 780 patients, 16,794 (23.9%) of 70,200 doses were missed, 9,487 of which were from suboptimal dosing implementation (56.5%). By 60 days, 5.1% of participants had discontinued, and 14.4% had discontinued by 120 days. Most participants (95.9%) missed at least one dose. The majority of gaps were of a single dose (71.4%), although 22.6% of participants had at least one gap of 2 weeks or more. In adjusted models, the initiation-continuation phase transition (odds ratio, 3.07 [95% confidence interval, 2.68-3.51]) and national holidays (1.52 [1.39-1.65]) were associated with increased odds of suboptimal dosing implementation. Early-stage suboptimal dosing implementation was associated with increased discontinuation rates. Conclusions:  Digital tools provide an unprecedented step change in describing and addressing nonadherence. In our setting, nonadherence was common; patients displayed a complex range of patterns. Dividing nonadherence into suboptimal dosing implementation and discontinuation, we found that both increased over time. Discontinuation was associated with early suboptimal dosing implementation. These apparent causal associations between temporal factors and nonadherence present opportunities for targeted interventions.Clinical trial registered with the ISRCTN Registry (ISRCTN46846388).",2020,"In adjusted models, the initiation-continuation phase transition (odds ratio 3.07 [95% confidence interval 2.68-3.51]) and national holidays (1.52 [1.39-1.65]) were associated with increasing odds of suboptimal dosing implementation.","['780 patients, 16,794 of 70,200 doses were missed (23.9%), 9,487 from suboptimal dosing implementation (56.5', 'Pulmonary tuberculosis patients enrolled in the control arm of a pragmatic cluster-randomized trial in China of']","['electronic reminders', 'Tuberculosis Treatment']",['national holidays'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],780.0,0.0701584,"In adjusted models, the initiation-continuation phase transition (odds ratio 3.07 [95% confidence interval 2.68-3.51]) and national holidays (1.52 [1.39-1.65]) were associated with increasing odds of suboptimal dosing implementation.","[{'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Stagg', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Lewis', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Xiaoqiu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Huan', 'Affiliation': 'China Office, Bill & Melinda Gates Foundation, Beijing, China; and.'}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Chin', 'Affiliation': 'China Office, Bill & Melinda Gates Foundation, Beijing, China; and.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Fielding', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201905-394OC']
498,32198301,What are potential barriers and enablers to patient and physician participation in Canadian cell therapy trials for stroke? A stakeholder interview study.,"OBJECTIVES


Early phase cell therapy trials face many barriers to successful, timely completion. To optimise the conduct of a planned clinical trial of mesenchymal stem cell (MSC) therapy for chronic stroke, we sought patient and physician views on possible barriers and enablers that may influence their participation.
DESIGN


Semistructured interview study.
SETTING


Patients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling.
PARTICIPANTS


Thirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study. Data adequacy was reached after 13 patient interviews and 13 physician interviews.
METHODS


Interview guides and directed content analysis were based on the Theoretical Domains Framework (TDF). Interviews were coded, and relevant themes were identified.
RESULTS


Most patients were optimistic about participating in an MSC therapy clinical trial, and many expressed interest in participating, even if it was a randomised controlled trial with the possibility of being allocated to a placebo group. However, the method of administration of cells (intravascular preferred to intracerebral) and goal of the trial (efficacy preferred to safety) may influence their intention to participate. All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial. Physicians also identified several time-related barriers and the need for resources to ensure feasibility.
CONCLUSIONS


This novel application of the TDF helped identify key potential barriers and enablers prior to conducting a clinical trial of MSC therapy for stroke. This will be used to refine the design and conduct of our trial. A similar approach may be adopted by other investigators considering early phase cell therapy trials.",2020,"All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial.","['Patients were recruited from three rehabilitation centres in Ontario, Canada; physicians were recruited from across Canada through snowball sampling', 'Thirteen chronic stroke patients (patients who had experienced a stroke at least 3 months prior; 10 male, 3 female) and 15 physicians (stroke physiatrists; 9 male, 6 female) participated in our interview study']","['TDF', 'mesenchymal stem cell (MSC) therapy', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0260138', 'cui_str': 'Physiatrists'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0805287,"All physicians expressed interest in screening for the trial, though many stated they were less motivated to contribute to a safety trial.","[{'ForeName': 'Manoj M', 'Initials': 'MM', 'LastName': 'Lalu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Gisell', 'Initials': 'G', 'LastName': 'Castillo', 'Affiliation': 'Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Analyssa', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Tam', 'Affiliation': 'Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zlepnig', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Timpson', 'Affiliation': 'Department of Rehabilitation, Pembroke Regional Hospital, Pembroke, Ontario, Canada.'}, {'ForeName': 'Yuan Yi', 'Initials': 'YY', 'LastName': 'Dong', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Juneau', 'Affiliation': 'Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada dafergusson@ohri.ca.'}]",BMJ open,['10.1136/bmjopen-2019-034354']
499,32198306,Impact of a short version of the CONSORT checklist for peer reviewers to improve the reporting of randomised controlled trials published in biomedical journals: study protocol for a randomised controlled trial.,"INTRODUCTION


Transparent and accurate reporting is essential for readers to adequately interpret the results of a study. Journals can play a vital role in improving the reporting of published randomised controlled trials (RCTs). We describe an RCT to evaluate our hypothesis that asking peer reviewers to check whether the most important and poorly reported CONsolidated Standards of Reporting Trials (CONSORT) items are adequately reported will result in higher adherence to CONSORT guidelines in published RCTs.
METHODS AND ANALYSIS


Manuscripts presenting the primary results of RCTs submitted to participating journals will be randomised to either the intervention group (peer reviewers will receive a reminder and short explanation of the 10 most important and poorly reported CONSORT items; they will be asked to check if these items are reported in the submitted manuscript) or a control group (usual journal practice). The primary outcome will be the mean proportion of the 10 items that are adequately reported in the published articles. Peer reviewers and manuscript authors will not be informed of the study hypothesis, design or intervention. Outcomes will be assessed in duplicate from published articles by two data extractors (at least one blinded to the intervention). We will enrol eligible manuscripts until a minimum of 83 articles per group (166 in total) are published.
ETHICS AND DISSEMINATION


This pragmatic RCT was approved by the Medical Sciences Interdivisional Research Ethics Committee of the University of Oxford (R62779/RE001). If this intervention is effective, it could be implemented by all medical journals without requiring large additional resources at journal level. Findings will be disseminated through presentations in relevant conferences and peer-reviewed publications. This trial is registered on the Open Science Framework (https://osf.io/c4hn8).",2020,This pragmatic RCT was approved by the Medical Sciences Interdivisional Research Ethics Committee of the University of Oxford (R62779/RE001).,['Manuscripts presenting the primary results of RCTs submitted to participating journals'],[],['mean proportion of the 10 items'],"[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.174324,This pragmatic RCT was approved by the Medical Sciences Interdivisional Research Ethics Committee of the University of Oxford (R62779/RE001).,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Speich', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK benjamin.speich@ndorms.ox.ac.uk.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'The BMJ, London, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Briel', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Puebla', 'Affiliation': 'PLOS ONE, Public Library of Science, Cambridge, UK.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'PLOS ONE, Public Library of Science, Cambridge, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maia Schlüssel', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': 'Université de Paris, CRESS, Inserm, INRA, F75004, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Université de Paris, CRESS, Inserm, INRA, F75004, Paris, France.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035114']
500,31558501,Cerebral Venous Thrombosis: MR Black-Blood Thrombus Imaging with Enhanced Blood Signal Suppression.,"BACKGROUND AND PURPOSE


The residual blood flow artifact is a critical confounder for MR black-blood thrombus imaging of cerebral venous sinus thrombosis. This study aimed to conduct a validation of a new MR black-blood thrombus imaging technique with enhanced blood signal suppression.
MATERIALS AND METHODS


Twenty-six participants (13 volunteers and 13 patients) underwent conventional imaging methods followed by 2 randomized black-blood thrombus imaging scans, with a preoptimized delay alternating with nutation for tailored excitation (DANTE) preparation switched on and off, respectively. The signal intensity of residual blood, thrombus, brain parenchyma, normal lumen, and noise on black-blood thrombus images were measured. The thrombus volume, SNR of residual blood, and contrast-to-noise ratio for residual blood versus normal lumen, thrombus versus residual blood, and brain parenchyma versus normal lumen were compared between the 2 black-blood thrombus imaging techniques. Segmental diagnosis of venous sinus thrombosis was evaluated for each black-blood thrombus imaging technique using a combination of conventional imaging techniques as a reference.
RESULTS


In the volunteer group, the SNR of residual blood (11.3 ± 2.9 versus 54.0 ± 23.4,  P  < .001) and residual blood-to-normal lumen contrast-to-noise ratio (7.5 ± 3.4 versus 49.2 ± 23.3,  P  < .001) were significantly reduced using the DANTE preparation. In the patient group, the SNR of residual blood (16.4 ± 8.0 versus 75.0 ± 35.1,  P  = .002) and residual blood-to-normal lumen contrast-to-noise ratio (12.4 ± 7.8 versus 68.8 ± 35.4,  P  = .002) were also significantly lower on DANTE-prepared black-blood thrombus imaging. The new black-blood thrombus imaging technique provided higher thrombus-to-residual blood contrast-to-noise ratio, significantly lower thrombus volume, and substantially improved diagnostic specificity and agreement with conventional imaging methods.
CONCLUSIONS


DANTE-prepared black-blood thrombus imaging is a reliable MR imaging technique for diagnosing cerebral venous sinus thrombosis.",2019,"Segmental diagnosis of venous sinus thrombosis was evaluated for each black-blood thrombus imaging technique using a combination of conventional imaging techniques as a reference.
",['Twenty-six participants (13 volunteers and 13 patients) underwent'],"['conventional imaging methods followed by 2 randomized black-blood thrombus imaging scans, with a preoptimized delay alternating with nutation for tailored excitation (DANTE) preparation']","['thrombus volume, SNR of residual blood, and contrast-to-noise ratio for residual blood versus normal lumen, thrombus versus residual blood, and brain parenchyma versus normal lumen', 'Segmental diagnosis of venous sinus thrombosis', 'residual blood-to-normal lumen contrast-to-noise ratio', 'signal intensity of residual blood, thrombus, brain parenchyma, normal lumen, and noise on black-blood thrombus images', 'SNR of residual blood']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441633'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1562171', 'cui_str': 'Segmental diagnosis'}, {'cui': 'C0226504', 'cui_str': 'Structure of venous sinus'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",26.0,0.0156739,"Segmental diagnosis of venous sinus thrombosis was evaluated for each black-blood thrombus imaging technique using a combination of conventional imaging techniques as a reference.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Radiology (X.Y., Q.Y.) Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Departments of Emergency (J.D., X.J.).'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Paul C. Lauterbur Research Center for Biomedical Imaging (N.Z.), Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, China.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Maya', 'Affiliation': 'Department of Imaging (M.M.M.), Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Bi', 'Affiliation': 'MR R&D (X.B., D.L.), Siemens Healthineers, Los Angeles, California.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Departments of Emergency (J.D., X.J.).'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute Zhaoyang.Fan@csmc.edu yangyangqiqi@gmail.com.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute Zhaoyang.Fan@csmc.edu yangyangqiqi@gmail.com.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6212']
501,32223688,Is it possible that direct rigid laryngoscope-related ischemia-reperfusion injury occurs in the tongue during suspension laryngoscopy as detected by ultrasonography: a prospective controlled study.,"Background:  Tongue-related complications can be seen in suspension laryngoscopy (SL) procedures. Aims/objectives:  This study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using ultrasonography (USG) in patients undergoing SL procedures. Material and methods:  The study group included 31 patients and the control group consisted of 33 patients. Submental USG examinations of the tongue in the coronal plane were performed. In the study and control groups, the first examination (TA 1 ) was done immediately after intubation and the second examination (TA 2 ) was done after the surgery procedure but before extubation. The USG results regarding tongue area for both the groups were compared. Results:  The study and control groups significantly differed in terms of the postoperative tongue area measurements (TA 2 ), as well as tongue edema (based on the TA 2  - TA 1 ) values. Conclusions and significance:  Direct rigid laryngoscopes may cause tongue edema in SL procedures which was demonstrated by the USG. This tongue edema can be a result of ischemia-reperfusion injury in the tongue due to the pressure exerted by a direct rigid laryngoscope. This study is the first to demonstrate the possible role of USG examination in determining the side effects of SL procedures on the tongue. Trial Registration ClinicalTrials.gov Identifier: NCT04205253.",2020,"The study and control groups significantly differed in terms of the postoperative tongue area measurements (TA 2 ), as well as tongue edema (based on the TA 2  - TA 1 ) values.","['31 patients and the control group consisted of 33 patients', 'patients undergoing SL procedures']",['rigid direct laryngoscope by measuring the tongue area using ultrasonography (USG'],"['postoperative tongue area measurements (TA 2 ), as well as tongue edema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0151610', 'cui_str': 'Edema of the tongue (disorder)'}]",33.0,0.0246648,"The study and control groups significantly differed in terms of the postoperative tongue area measurements (TA 2 ), as well as tongue edema (based on the TA 2  - TA 1 ) values.","[{'ForeName': 'Merih', 'Initials': 'M', 'LastName': 'Onal', 'Affiliation': 'Department of Otolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Colpan', 'Affiliation': 'Department of Otolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Cagdas', 'Initials': 'C', 'LastName': 'Elsurer', 'Affiliation': 'Department of Otolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Mete Kaan', 'Initials': 'MK', 'LastName': 'Bozkurt', 'Affiliation': 'Department of Otolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Ozkan', 'Initials': 'O', 'LastName': 'Onal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}]",Acta oto-laryngologica,['10.1080/00016489.2020.1743353']
502,31523014,Effect of a Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control in India: A Cluster Randomized Controlled Trial.,"BACKGROUND


Eighty percent of premature mortality from cardiovascular disease occurs in low- and middle-income countries. Hypertension, diabetes, and smoking are the top risk factors causing this disease burden.
OBJECTIVES


The study aimed to test the hypothesis that utilizing community health workers (CHWs) to manage hypertension, diabetes and smoking in an integrated manner would lead to improved control of these conditions.
METHODS


This was a 2-year cluster (n = 12) randomized controlled trial of 3,556 adults (35 to 70 years of age) in a single town in India, who were screened at home for hypertension, diabetes, and smoking. Of these adults, 1,242 (35%) had at least 1 risk factor (hypertension = 650, diabetes = 317, smoking = 500) and were enrolled in the study. The intervention group had behavioral change communication through regular home visits from community health workers. The control group received usual care in the community. The primary outcomes were changes in systolic blood pressure, fasting blood glucose, and average number of cigarettes/bidis smoked daily among individuals with respective risk factors.
RESULTS


The mean ± SD change in systolic blood pressure at 2 years was -12.2 ± 19.5 mm Hg in the intervention group as compared with -6.4 ± 26.1 mm Hg in the control group, resulting in an adjusted difference of -8.9 mm Hg (95% confidence interval [CI]: -3.5 to -14.4 mm Hg; p = 0.001). The change in fasting blood glucose was -43.0 ± 83.5 mg/dl in the intervention group and -16.3 ± 77.2 mg/dl in the control group, leading to an adjusted difference of -21.3 mg/dl (95% CI: 18.4 to -61 mg/dl; p = 0.29). The change in mean number of cigarettes/bidis smoked was nonsignificant at +0.2 cigarettes/bidis (95% CI: 5.6 to -5.2 cigarettes/bidis; p = 0.93).
CONCLUSIONS


A population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking. (Study of a Community-Based Approach to Control Cardiovascular Risk Factors in India [SEHAT]; NCT02115711).",2019,"CONCLUSIONS


A population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking.","['India', 'Of these adults, 1,242 (35%) had at least 1 risk factor (hypertension\xa0= 650, diabetes\xa0= 317, smoking\xa0= 500) and were enrolled in the study', '3,556 adults (35 to 70 years of age) in a single town in India, who were screened at home for hypertension, diabetes, and smoking']","['usual care in the community', 'Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control', 'utilizing community health workers (CHWs']","['systolic blood pressure, fasting blood glucose, and average number of cigarettes/bidis smoked daily among individuals with respective risk factors', 'behavioral change communication', 'mean number of cigarettes/bidis smoked', 'fasting blood glucose', 'mean ± SD change in systolic blood pressure', 'systolic blood pressure']","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C2984220', 'cui_str': 'Bidis Tobacco'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",3556.0,0.113259,"CONCLUSIONS


A population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking.","[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Khetan', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA; SEHAT, Dalkhola, India. Electronic address: dradityakhetan@gmail.com.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zullo', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA; School of Public Health, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Rani', 'Affiliation': 'Department of Community Medicine, Sri Ramachandra Medical College and Research Institute, Porur, India.'}, {'ForeName': 'Rishab', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'SEHAT, Dalkhola, India.'}, {'ForeName': 'Raghunandan', 'Initials': 'R', 'LastName': 'Purushothaman', 'Affiliation': 'SEHAT, Dalkhola, India.'}, {'ForeName': 'Navkaranbir S', 'Initials': 'NS', 'LastName': 'Bajaj', 'Affiliation': 'Division of Cardiovascular Disease, Department of Internal Medicine and Radiology, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'SEHAT, Dalkhola, India.'}, {'ForeName': 'Sri Krishna', 'Initials': 'SK', 'LastName': 'Madan Mohan', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Josephson', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA; School of Public Health, Kent State University, Kent, OH, USA.'}]",Global heart,['10.1016/j.gheart.2019.08.003']
503,32058423,Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],"['Intraarticular Tranexamic Acid', 'Letter to the Editor']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.143475,,"[{'ForeName': 'Saubhik', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'S. Das, Assistant Professor, Orthopaedics, Rajendra Institute of Medical Sciences (RIMS), Ranchi, India.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001163']
504,31728054,Randomized assessment of delayed intensification and two methods for parenteral methotrexate delivery in childhood B-ALL: Children's Oncology Group Studies P9904 and P9905.,"The delayed intensification (DI) enhanced outcome for patients with acute lymphoblastic leukemia (ALL) treated on BFM 76/79 and CCG 105 after a prednisone-based induction. Childrens Oncology Group protocols P9904/9905 evaluated DI via a post-induction randomization for eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients. A second randomization compared intravenous methotrexate (IV MTX) as a 24- (1 g/m 2 ) vs. 4-h (2 g/m 2 ) infusion. NCI SR patients received a dexamethasone-based three-drug and NCI HR/CNS 3 SR patients a prednisone-based four-drug induction. End induction MRD (minimal residual disease) was obtained but did not impact treatment. DI improved the 10-year continuous complete remission (CCR) rate; 75.5 ± 2.5% vs. 81.8 ± 2.2% p = 0.002, whereas MTX administration did not; 4-h 80.8 ± 1.9%; 24-h 81.4 ± 1.9% (p = 0.7780). Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209). MRD predicted outcome; 10-year CCR 87.7 ± 2.2 and 82.1 ± 2.5% when MRD was <0.01% with/without DI (p = 0.007) and 54.3 ± 8% and 44 ± 8% for patients with MRD ≥ 0.01% with/without DI (p = 0.11). DI improved CCR for patients with B-ALL with and without end induction MRD.",2020,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"['eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients', 'Childrens Oncology Group protocols', ""childhood B-ALL: Children's Oncology Group Studies P9904 and P9905"", 'patients with acute lymphoblastic leukemia (ALL) treated on']","['NCI SR', 'dexamethasone', 'MTX', 'BFM', 'intravenous methotrexate (IV MTX']","['Overall survival (OS', 'DI improved CCR', '10-year continuous complete remission']","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0328713,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA. naomi.winick@utsouthwestern.edu.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': 'Department of Health Outcomes and Policy, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology and Oncology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Paul Bowman', 'Affiliation': 'Department of Pediatrics, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Maine Children's Cancer Program, Scarborough, ME, USA.""}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Pullen', 'Affiliation': 'Department of Pediatrics, University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Willman', 'Affiliation': 'Cancer Center and Departments of Internal Medicine and Pathology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, and the Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and The Perlmutter Cancer Center, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Camitta', 'Affiliation': 'Department of Pediatrics, Midwest Center for Cancer and Blood Disorders, Medical College of Wisconsin, Milwaukee, WI, USA.'}]",Leukemia,['10.1038/s41375-019-0642-2']
505,31939054,Adducts Post Acetaminophen Overdose Treated with a 12-Hour vs 20-Hour Acetylcysteine Infusion.,"INTRODUCTION


Acetaminophen protein adducts in the circulation are a specific biomarker of acetaminophen oxidation, and may be a more sensitive measure of impending hepatic injury following overdose than alanine transaminase (ALT). We performed an exploratory analytical substudy of adducts during a clinical trial (NACSTOP) of abbreviated (12-hour) versus control (20-hour) acetylcysteine to identify any signal of diminished antidotal effectiveness with shortened therapy.
METHODS


We measured adducts at 0, 12, and 20 hours from a convenience sample of subjects enrolled in the cluster-controlled NACSTOP trial evaluating a 12-hour (""abbreviated""; 200 mg/kg over 4 hours, 50 mg/kg over 8 hours) vs 20-hour acetylcysteine regimen (""control""; 200 mg/kg over 4 hours, 100 mg/kg over 16 hours). Adducts were assayed using high-performance liquid chromatography/mass spectrometry.
RESULTS


Median ALT 20 hours after the initiation of acetylcysteine was 12 U/L (IQR 8,14) in the abbreviated 12-hour regimen group (N = 8), compared with the control group 16 U/L (IQR 11,21; N = 21) (p = 0.46). Adduct concentrations were similarly low in both groups: abbreviated [(0.005 μmol/L, IQR (0,0.14)] and control [(0.005 μmol/L, IQR (0,0.05)] (p = 0.61).
CONCLUSIONS


There were minimal to no acetaminophen protein adducts detected. These findings further support discontinuing acetylcysteine when acetaminophen concentrations are low and liver function tests normal after 12 hours of treatment.",2020,"Adduct concentrations were similarly low in both groups: abbreviated [(0.005 μmol/L, IQR (0,0.14)] and control [(0.005 μmol/L, IQR (0,0.05)] (p = 0.61).
",[],"['abbreviated (12-hour) versus control (20-hour) acetylcysteine', 'Acetaminophen Overdose Treated with a 12-Hour vs 20-Hour Acetylcysteine Infusion']",['Adduct concentrations'],[],"[{'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0572025', 'cui_str': 'Acetaminophen overdose'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0541846,"Adduct concentrations were similarly low in both groups: abbreviated [(0.005 μmol/L, IQR (0,0.14)] and control [(0.005 μmol/L, IQR (0,0.05)] (p = 0.61).
","[{'ForeName': 'Anselm', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Melbourne, Victoria, Australia. anselm.wong@austin.org.au.'}, {'ForeName': 'Kennon', 'Initials': 'K', 'LastName': 'Heard', 'Affiliation': 'Rocky Mountain Poison and Drug Center, Denver Health and Hospitals, Denver, CO, USA.'}, {'ForeName': 'Andis', 'Initials': 'A', 'LastName': 'Graudins', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dart', 'Affiliation': 'Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, USA.'}, {'ForeName': 'Marco L A', 'Initials': 'MLA', 'LastName': 'Sivilotti', 'Affiliation': ""Departments of Emergency Medicine, and of Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada.""}]",Journal of medical toxicology : official journal of the American College of Medical Toxicology,['10.1007/s13181-020-00757-9']
506,32227247,Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial.,"Background


Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinson disease (PD).
Objective


To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD.
Design


Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842).
Setting


57 Parkinson Study Group sites in North America.
Participants


Patients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment.
Intervention


5 mg of immediate-release isradipine twice daily or placebo for 36 months.
Measurements


The primary outcome was change in the Unified Parkinson's Disease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication ""ON"" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures.
Results


336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study. Adjusted least-squares mean changes in total UPDRS score in the antiparkinson medication ON state over 36 months for isradipine and placebo recipients were 2.99 (95% CI, 0.95 to 5.03) points versus 3.26 (CI, 1.25 to 5.26) points, respectively, with a treatment effect of -0.27 (CI, -3.02 to 2.48) point (P = 0.85). Statistical adjustment for antiparkinson medication use did not change the findings. Secondary outcomes showed no effect of isradipine treatment. The most common adverse effects of isradipine were edema and dizziness.
Limitation


The isradipine dose may have been insufficient to engage the target calcium channels associated with neuroprotective effects.
Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
Primary Funding Source


National Institute of Neurological Disorders and Stroke.",2020,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","['336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study', 'Participants\n\n\nPatients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment', 'Setting\n\n\n57 Parkinson Study Group sites in North America', 'Early Parkinson Disease']","['dihydropyridine calcium-channel blocker', 'placebo', 'dihydropyridine calcium-channel blockers', 'isradipine', 'Intervention\n\n\n5 mg of immediate-release isradipine twice daily or placebo', 'Isradipine Versus Placebo']","[""Unified Parkinson's Disease Rating Scale (UPDRS) parts"", 'time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures', 'total UPDRS score', 'edema and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",336.0,0.515182,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2534']
507,30807279,Working Memory Performance Following Acute Alcohol: Replication and Extension of Dose by Age Interactions.,"OBJECTIVE


Despite the substantial number of older adult drinkers, few studies have examined acute alcohol effects in aging samples. We have explored these interactions across a variety of neurobehavioral domains and modalities and have consistently observed age-contingent vulnerabilities to alcohol-associated decrements in neurobehavioral functions. However, these studies have not been sufficiently powered to address sex differences, and, thus far, no attempt has been made to replicate results. The current study addresses these gaps.
METHOD


The study used a double-blind, placebo-controlled, factorial design with two age groups (older, 55-70 years; younger, 25-35 years) and three doses (target breath alcohol concentrations: .00, .04, and .065 g/dl). Replication analyses used an independent sample (n = 90) to replicate age-contingent alcohol effects reported by Boissoneault (n = 90). Samples were combined (N = 180; 91 women) to enable sex analyses. The dependent measure was performance efficiency in a visual working memory task.
RESULTS


A complex interaction between sex, age, and dose, F(2, 178) = 4.15, p = .02, appeared driven by age-contingent divergence in working memory performance, which was most pronounced between women at the .065 dose, t(28) = 4.61, p < .01, d = 1.68. Replication analyses revealed a pattern of age differences consistent with previous results, although the previously reported age by alcohol interaction failed to reach statistical significance.
CONCLUSIONS


Results provide further support for the hypothesis that neurobehavioral effects of acute alcohol are age dependent and offer evidence that this interaction may be moderated by sex. Extensions of this work are needed to identify underlying processes and ascertain the functional impact of these effects on the health and well-being of aging adult drinkers.",2019,"Replication analyses revealed a pattern of age differences consistent with previous results, although the previously reported age by alcohol interaction failed to reach statistical significance.
","['older adult drinkers', 'two age groups (older, 55-70 years; younger, 25-35 years) and three doses (target breath alcohol concentrations: .00, .04, and .065 g/dl']",['placebo'],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0458127,"Replication analyses revealed a pattern of age differences consistent with previous results, although the previously reported age by alcohol interaction failed to reach statistical significance.
","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Julianne L', 'Initials': 'JL', 'LastName': 'Price', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}]",Journal of studies on alcohol and drugs,[]
508,30985304,Hemodynamic Effects of Concomitant Mitral Valve Surgery and Left Ventricular Assist Device Implantation.,"There are conflicting data regarding whether concomitant mitral valve surgery (MVS) at left ventricular assist device (LVAD) implantation is beneficial. This study aimed to assess the hemodynamic effects of concomitant MVS. Of all 73 enrolled patients, 44 patients had undergone concomitant MVS and 29 patients had not. Before LVAD implantation, MVS group had higher pulmonary capillary wedge pressure (p = 0.04). After LVAD implantation, MVS group had higher mean pulmonary artery pressure and cardiac output (CO). During the hemodynamic ramp study, MVS group had steeper CO slopes (0.18 [0.13 0.28] vs. 0.15 [0.08, 0.20] L/min/step; p = 0.04) at incremental LVAD speed and achieved a higher CO at the optimized set speed (5.5 [4.7, 6.9] vs. 4.9 [4.0, 5.7] L/min; p = 0.03). One-year freedom from death or heart failure readmission was statistically comparable between the two groups (61% vs. 80%, p = 0.20). Thus far, after LVAD implantation and concomitant MVS, patients had increased pulmonary hypertension, despite having higher CO and a better response of CO at incremental LVAD speed. The implication of hemodynamic features after concomitant MVS on clinical outcomes warrants further investigation.",2020,"Before LVAD implantation, MVS group had higher pulmonary capillary wedge pressure (p = 0.04).","['73 enrolled patients, 44 patients had undergone concomitant MVS and 29 patients had not']","['Concomitant Mitral Valve Surgery and Left Ventricular Assist Device Implantation', 'concomitant MVS', 'MVS', 'concomitant mitral valve surgery (MVS) at left ventricular assist device (LVAD) implantation']","['pulmonary capillary wedge pressure', 'mean pulmonary artery pressure and cardiac output (CO', 'death or heart failure readmission', 'pulmonary hypertension', 'steeper CO slopes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]",73.0,0.0655611,"Before LVAD implantation, MVS group had higher pulmonary capillary wedge pressure (p = 0.04).","[{'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Imamura', 'Affiliation': ''}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Nnanabu', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodgers', 'Affiliation': ''}, {'ForeName': 'Jayant', 'Initials': 'J', 'LastName': 'Raikehlkar', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kalantar', 'Affiliation': ''}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Narang', 'Affiliation': ''}, {'ForeName': 'Takeyoshi', 'Initials': 'T', 'LastName': 'Ota', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Tae', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Columbia University Medical Center, and Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Valluvan', 'Initials': 'V', 'LastName': 'Jeevanandam', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sayer', 'Affiliation': ''}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': ''}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000000999']
509,30226112,A Comparative Effectiveness Trial of Depression Collaborative Care: Subanalysis of Comorbid Anxiety.,"The purpose of this exploratory subanalysis was to compare the effects of two depression quality improvement approaches on clinical outcomes and service utilization for individuals with comorbid depression/anxiety. This study used data from Community Partners in Care (CPIC), a cluster-randomized comparative effectiveness trial ( N  = 1,018; depression = 360; comorbid depression/anxiety = 658). Each intervention arm received the same quality improvement materials, plus either technical support (Resources for Services, RS) or support for collaborative implementation planning (Community Engagement and Planning, CEP). For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months. The effects were not significant at 12 months. A collaborative planning process versus technical support for depression quality improvement can have short-term effects on mental wellness and social determinants of health among those with comorbid depression/anxiety.",2019,"For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months.","['individuals with comorbid depression/anxiety', 'Community Partners in Care (CPIC), a cluster-randomized comparative effectiveness trial ( N  = 1,018; depression = 360; comorbid depression/anxiety = 658']","['same quality improvement materials, plus either technical support (Resources for Services, RS) or support for collaborative implementation planning (Community Engagement and Planning, CEP', 'depression quality improvement approaches']","['behavioral hospitalizations and homelessness risk', 'mental health-related quality of life and mental wellness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0486457,"For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months.","[{'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Choi', 'Affiliation': '1 Division of General Internal Medicine & Health Services Research, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sherbourne', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Lingqi', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': '3 David Geffen School of Medicine at UCLA, CA, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Castillo', 'Affiliation': '5 Los Angeles County Department of Mental Health, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dixon', 'Affiliation': '6 UCLA School of Nursing, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': '7 Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Eisen', 'Affiliation': '5 Los Angeles County Department of Mental Health, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}]",Western journal of nursing research,['10.1177/0193945918800333']
510,32154945,Bone Adaptation in Adult Women Is Related to Loading Dose: A 12-Month Randomized Controlled Trial.,"Although strong evidence exists that certain activities can increase bone density and structure in people, it is unclear what specific mechanical factors govern the response. This is important because understanding the effect of mechanical signals on bone could contribute to more effective osteoporosis prevention methods and efficient clinical trial design. The degree to which strain rate and magnitude govern bone adaptation in humans has never been prospectively tested. Here, we studied the effects of a voluntary upper extremity compressive loading task in healthy adult women during a 12-month prospective period. A total of 102 women age 21 to 40 years participated in one of two experiments: (i) low (n = 21) and high (n = 24) strain magnitude; or (ii) low (n = 21) and high (n = 20) strain rate. Control (n = 16) no intervention. Strains were assigned using subject-specific finite element models. Load cycles were recorded digitally. The primary outcome was change in ultradistal radius integral bone mineral content (iBMC), assessed with QCT. Interim time points and secondary outcomes were assessed with high resolution pQCT (HRpQCT) at the distal radius. Sixty-six participants completed the intervention, and interim data were analyzed for 77 participants. Likely related to improved compliance and higher received loading dose, both the low-strain rate and high-strain rate groups had significant 12-month increases to ultradistal iBMC (change in control: -1.3 ± 2.7%, low strain rate: 2.7 ± 2.1%, high strain rate: 3.4 ± 2.2%), total iBMC, and other measures. ""Loading dose"" was positively related to 12-month change in ultradistal iBMC, and interim changes to total BMD, cortical thickness, and inner trabecular BMD. Participants who gained the most bone completed, on average, 128 loading bouts of (mean strain) 575 με at 1878 με/s. We conclude that signals related to strain magnitude, rate, and number of loading bouts contribute to bone adaptation in healthy adult women, but only explain a small amount of variance in bone changes. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,"""Loading dose"" was positively related to 12-month change in ultradistal iBMC, and interim changes to total BMD, cortical thickness and inner trabecular BMD.","['21-40 participated in one of two experiments', 'Sixty-six participants completed the intervention, and interim data were analyzed for 77 participants', 'healthy adult women during a twelve month prospective period', 'healthy adult women', 'adult women', 'One hundred and two women age', 'Participants who gained the most bone completed, on average, 128 loading bouts of (mean strain) 575 με at 1878 με/s']",['voluntary upper extremity compressive loading task'],"['high resolution pQCT (HRpQCT', 'ultradistal radius integral bone mineral content (iBMC), assessed with QCT', 'total BMD, cortical thickness and inner trabecular BMD', 'ultradistal iBMC', 'Bone adaptation', 'total iBMC']","[{'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3844102', 'cui_str': '575'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]",102.0,0.0668237,"""Loading dose"" was positively related to 12-month change in ultradistal iBMC, and interim changes to total BMD, cortical thickness and inner trabecular BMD.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Troy', 'Affiliation': 'Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester, MA, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': 'Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester, MA, USA.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Johnson', 'Affiliation': 'Orthopaedic Biomechanics Research Laboratory, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Zheyang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Mathematical Sciences, Worcester Polytechnic Institute, Worcester, MA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schnitzer', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Tiffiny A', 'Initials': 'TA', 'LastName': 'Butler', 'Affiliation': 'Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester, MA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3999']
511,32087380,No Faculty Required: Use of a Health Literacy Low Inference Self-Assessment Measure to Promote Behavior Change.,"OBJECTIVE


To determine if use of a health literacy low-inference, self-assessment measure (LISAM), promoted behavior change as measured by increased use of health literacy communication skills (HLCS).
METHODS


The LISAM is a tool used by educators to self-assess their performances after giving a lecture. The tool is low inference because it self-assesses behaviors that are specific, with little room for subjectivity. Forty-four third-year medical students self-assessed HLCS using a LISAM modified to include health literacy communication skills (LISAM-HLCS).  Self-assessment followed participation in an audio recorded, standardized patient encounter and again after listening to the recording.  Students also created 3 written goals for improvement.  This session was repeated 1 week later.
RESULTS


At Session 2, 71.4% of students met at least 2 of their 3 self-created objectives. The 3 most commonly created objectives were using teach-back, asking more open ended questions, and obtaining patient input into the management plan. Use of the LISAM increased HLCS use at Session 2 versus Session 1 as assessed by both students and study investigators (P < .05).
CONCLUSIONS


Without faculty present, students met and adjusted objectives, catalyzing changes in HLCS. The LISAM-HLCS has the potential to empower students to improve communication skills and to reduce dependence on faculty observations.",2020,"Use of the LISAM increased HLCS use at Session two vs. Session one as assessed by both students and study investigators (p<0.05).
",['Forty-four third-year medical students self-assessed HLCS using a LISAM modified to include health literacy communication skills (LISAM-HLCS'],"['health literacy low-inference, self-assessment measure (LISAM']",['health literacy communication skills (HLCS'],"[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",,0.0128153,"Use of the LISAM increased HLCS use at Session two vs. Session one as assessed by both students and study investigators (p<0.05).
","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex. Electronic address: Aditi.gupta@bcm.edu.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wood', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex.""}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex; Center for Research, Innovation and Scholarship in Medical Education, Texas Children's Hospital (S Kumar and T Turner), Houston, Tex.""}, {'ForeName': 'Sanghamitra', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex.""}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Turner', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex; Center for Research, Innovation and Scholarship in Medical Education, Texas Children's Hospital (S Kumar and T Turner), Houston, Tex.""}]",Academic pediatrics,['10.1016/j.acap.2020.02.019']
512,32202163,Motivational Interviewing to Increase Physical Activity Behavior in Cancer Patients: A Pilot Randomized Controlled Trials.,"OBJECTIVE


This pilot randomized controlled trial (RCT) aimed at evaluating the feasibility and potential efficacy of a motivational interviewing (MI) intervention to increase physical activity (PA) behavior in cancer patients.
METHODS


Participants were randomly assigned to an experimental group with standard care plus 12 MI sessions within 12 weeks or a control group with standard care only. The number of recruited participants and the modality of recruitment were recorded to describe the reach of the study. The acceptability of the study was estimated using the attrition rate during the intervention phase. The potential efficacy of the intervention was evaluated by analyzing the PA behavior.
RESULTS


Twenty-five participants were recruited within the 16-month recruitment period (1.6 participants per month). Five participants (38.5%) from the experimental group (n = 13) and one participant (8.3%) from the control group (n = 12) dropped out of the study before the end of the intervention phase. No group by time interaction effect for PA behavior was observed at the end of the intervention.
CONCLUSION


Due to the low recruitment rate and compliance, no conclusion can be drawn regarding the efficacy of MI to increase PA behavior in cancer patients. Moreover, the current literature cannot provide any evidence on the effectiveness of MI to increase PA in cancer survivors. Future RCTs should consider that the percentage of uninterested patients to join the study may be as high as 60%. Overrecruitment (30% to 40%) is also recommended to accommodate the elevated attrition rate.",2020,"No group by time interaction effect for PA behavior was observed at the end of the intervention.
","['cancer patients', 'Twenty-five participants were recruited within the 16-month recruitment period (1.6 participants per month', 'Cancer Patients', 'Participants']","['standard care plus 12 MI sessions within 12 weeks or a control group with standard care only', 'motivational interviewing (MI) intervention', 'Motivational Interviewing']","['physical activity (PA) behavior', 'elevated attrition rate', 'PA behavior', 'attrition rate', 'Physical Activity Behavior']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",25.0,0.0287656,"No group by time interaction effect for PA behavior was observed at the end of the intervention.
","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Lion', 'Affiliation': 'Fédération Luxembourgeoise des Associations de Sport de Santé, Strassen, Luxembourg.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Backes', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Duhem', 'Affiliation': 'Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.'}, {'ForeName': 'Fernand', 'Initials': 'F', 'LastName': 'Ries', 'Affiliation': 'Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Delagardelle', 'Affiliation': 'Fédération Luxembourgeoise des Associations de Sport de Santé, Strassen, Luxembourg.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Urhausen', 'Affiliation': 'Luxembourg Institute of Research in Orthopedics, Sports Medicine and Science, Luxembourg, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Theisen', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Malisoux', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}]",Integrative cancer therapies,['10.1177/1534735420914973']
513,32221582,Effects of dapagliflozin in DAPA-HF according to background heart failure therapy.,"AIMS


In the DAPA-HF trial, the SGLT2 inhibitor dapagliflozin reduced the risk of worsening heart failure (HF) and death in patients with HF and reduced ejection fraction. We examined whether this benefit was consistent in relation to background HF therapy.
METHODS AND RESULTS


In this post hoc analysis, we examined the effect of study treatment in the following yes/no subgroups: diuretic, digoxin, mineralocorticoid receptor antagonist (MRA), sacubitril/valsartan, ivabradine, implanted cardioverter-defibrillating (ICD) device, and cardiac resynchronization therapy. We also examined the effect of study drug according to angiotensin-converting enzyme inhibitor/angiotensin receptor blocker dose, beta-blocker (BB) dose, and MRA (≥50% and <50% of target dose). We analysed the primary composite endpoint of cardiovascular death or a worsening HF event. Most randomized patients (n = 4744) were treated with a diuretic (84%), renin-angiotensin system (RAS) blocker (94%), and BB (96%); 52% of those taking a BB and 38% taking a RAS blocker were treated with ≥50% of the recommended dose. Overall, the dapagliflozin vs. placebo hazard ratio (HR) was 0.74 [95% confidence interval (CI) 0.65-0.85] for the primary composite endpoint (P < 0.0001). The effect of dapagliflozin was consistent across all subgroups examined: the HR ranged from 0.57 to 0.86 for primary endpoint, with no significant randomized treatment-by-subgroup interaction. For example, the HR in patients taking a RAS blocker, BB, and MRA at baseline was 0.72 (95% CI 0.61-0.86) compared with 0.77 (95% CI 0.63-0.94) in those not on all three of these treatments (P-interaction 0.64).
CONCLUSION


The benefit of dapagliflozin was consistent regardless of background therapy for HF.",2020,"Overall, the dapagliflozin vs. placebo hazard ratio (HR) was 0.74 [95% confidence interval (CI) 0.65-0.85] for the primary composite endpoint (P < 0.0001).",[],"['angiotensin-converting enzyme inhibitor/angiotensin receptor blocker dose, beta-blocker (BB', 'dapagliflozin vs. placebo', 'diuretic', 'renin-angiotensin system', 'diuretic, digoxin, mineralocorticoid receptor antagonist (MRA), sacubitril/valsartan, ivabradine, implanted cardioverter-defibrillating (ICD) device, and cardiac resynchronization therapy', 'SGLT2 inhibitor dapagliflozin', 'dapagliflozin']","['risk of worsening heart failure (HF) and death', 'cardiovascular death or a worsening HF event']",[],"[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0035096'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",4744.0,0.252091,"Overall, the dapagliflozin vs. placebo hazard ratio (HR) was 0.74 [95% confidence interval (CI) 0.65-0.85] for the primary composite endpoint (P < 0.0001).","[{'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06510 USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, 4401 Wornall Road, Kansas City, MO 64111, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Av.Colon 2057, Cordoba X5003DSE, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Borowska 213, Wroclaw 50-556, Poland.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, 610 Walnut Street, 250 WARF, Madison, WI 53726, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Boston, MA 02115 USA.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Institute Cardiovascular de Buenos Aires, Av. Libertador 6302, C1428ART - Buenos Aires, Argentina.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'University of Calgary, Cardiac Sciences and Medicine, Room c838, 1403- 29th street NW, Calgary Alberta Canada, T2N2Y9.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, 65 Konyovitsa Str., Sofia 1309, Bulgaria.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg 413 45, Sweden.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute, University of Montreal, 5000 Belanger, Montreal, Quebec H1T1C8, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, Canada M5B 1W8.""}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc Cardiology Hospital, No. 04 Nguyen Luong Bang, Tan Phu Ward, District 7, Ho Chi Minh City 70000, Vietnam.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa183']
514,32094154,Prospective community programme versus parent-driven care to prevent respiratory morbidity in children following hospitalisation with severe bronchiolitis or pneumonia.,"BACKGROUND


Hospitalisation with severe lower respiratory tract infection (LRTI) in early childhood is associated with ongoing respiratory symptoms and possible later development of bronchiectasis. We aimed to reduce this intermediate respiratory morbidity with a community intervention programme at time of discharge.
METHODS


This randomised, controlled, single-blind trial enrolled children aged <2 years hospitalised for severe LRTI to 'intervention' or 'control'. Intervention was three monthly community clinics treating wet cough with prolonged antibiotics referring non-responders. All other health issues were addressed, and health resilience behaviours were encouraged, with referrals for housing or smoking concerns. Controls followed the usual pathway of parent-initiated healthcare access. After 24 months, all children were assessed by a paediatrician blinded to randomisation for primary outcomes of wet cough, abnormal examination (crackles or clubbing) or chest X-ray Brasfield score ≤22.
FINDINGS


400 children (203 intervention, 197 control) were enrolled in 2011-2012; mean age 6.9 months, 230 boys, 87% Maori/Pasifika ethnicity and 83% from the most deprived quintile. Final assessment of 321/400 (80.3%) showed no differences in presence of wet cough (33.9% intervention, 36.5% controls, relative risk (RR) 0.93, 95% CI 0.69 to 1.25), abnormal examination (21.7% intervention, 23.9% controls, RR 0.92, 95% CI 0.61 to 1.38) or Brasfield score ≤22 (32.4% intervention, 37.9% control, RR 0.85, 95% CI 0.63 to 1.17). Twelve (all intervention) were diagnosed with bronchiectasis within this timeframe.
INTERPRETATION


We have identified children at high risk of ongoing respiratory disease following hospital admission with severe LRTI in whom this intervention programme did not change outcomes over 2 years.
TRIAL REGISTRATION NUMBER


ACTRN12610001095055.",2020,"Final assessment of 321/400 (80.3%) showed no differences in presence of wet cough (33.9% intervention, 36.5% controls, relative risk (RR) 0.93, 95% CI 0.69 to 1.25), abnormal examination (21.7% intervention, 23.9% controls, RR 0.92, 95% CI 0.61 to 1.38) or Brasfield score ≤22 (32.4% intervention, 37.9% control, RR 0.85, 95% CI 0.63 to 1.17).","['children following hospitalisation with severe bronchiolitis or pneumonia', '400 children (203 intervention, 197 control) were enrolled in 2011-2012; mean age 6.9 months, 230 boys, 87% Maori/Pasifika ethnicity and 83% from the most deprived quintile', ""enrolled children aged <2 years hospitalised for severe LRTI to 'intervention' or 'control""]",['Prospective community programme versus parent-drive care'],"['wet cough, abnormal examination (crackles or clubbing) or chest X-ray Brasfield score ≤22', 'respiratory morbidity', 'presence of wet cough', 'abnormal examination']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0024770', 'cui_str': 'Maori (ethnic group)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]","[{'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",400.0,0.203638,"Final assessment of 321/400 (80.3%) showed no differences in presence of wet cough (33.9% intervention, 36.5% controls, relative risk (RR) 0.93, 95% CI 0.69 to 1.25), abnormal examination (21.7% intervention, 23.9% controls, RR 0.92, 95% CI 0.61 to 1.38) or Brasfield score ≤22 (32.4% intervention, 37.9% control, RR 0.85, 95% CI 0.63 to 1.17).","[{'ForeName': 'Catherine Ann', 'Initials': 'CA', 'LastName': 'Byrnes', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, The University of Auckland, Auckland, New Zealand c.byrnes@auckland.ac.nz.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Trenholme', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Lawrence', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Harley', 'Initials': 'H', 'LastName': 'Aish', 'Affiliation': 'Otara Family and Christian Health Centre, Otara, Auckland, New Zealand.'}, {'ForeName': 'Julie Anne', 'Initials': 'JA', 'LastName': 'Higham', 'Affiliation': 'Hunter Corner Medical Centre, Papatoetoe, Auckland, New Zealand.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hoare', 'Affiliation': 'Greenstone Family Clinic, Manurewa, Auckland, New Zealand.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Elborough', 'Affiliation': 'Pukekohe Family Health Centre, Pukekohe, Auckland, New Zealand.'}, {'ForeName': 'Charissa', 'Initials': 'C', 'LastName': 'McBride', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Le Comte', 'Affiliation': 'Counties Manukau District Health Board, Middlemore Clinical Trials Unit, Auckland, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McIntosh', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Florina', 'Initials': 'F', 'LastName': 'Chan Mow', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Jaksic', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Metcalfe', 'Affiliation': ""Department of Radiology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Coomarasamy', 'Affiliation': 'Research and Evaluation Office, Koawatea, Auckland, New Zealand.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Leung', 'Affiliation': 'Department of Health Economy, Wellington School of Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Teuila', 'Initials': 'T', 'LastName': 'Percival', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Henare', 'Initials': 'H', 'LastName': 'Mason', 'Affiliation': 'Koawatea, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Population Health, The University of Auckland, Auckland, New Zealand.'}]",Thorax,['10.1136/thoraxjnl-2019-213142']
515,32217561,Accuracy and consequences of using  trial-of-antibiotics  for TB diagnosis (ACT-TB study): protocol for a randomised controlled clinical trial.,"INTRODUCTION


Over 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include 'trial-of-antibiotics'-empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a 'rule-out' diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics.
METHODS AND ANALYSIS


A three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF ( Mycobacterium tuberculosis /rifampicin) and  Mycobacterium tuberculosis  culture) at baseline. We will use audiocomputer-assisted self-interview to assess clinical improvement at day 8. First primary outcome will be proportion of patients reporting day 8 improvement out of those with negative mycobacteriology (specificity). Second primary outcome will be day 29 incidence of a composite endpoint of either death or hospitalisation or missed tuberculosis diagnosis. To determine AMR impact we compare proportion of resistant nasopharyngeal  Streptococcus pneumoniae  isolates on day 29. 400 mycobacteriology-negative participants/arm will be required to detect a ≥10% absolute difference in diagnostic specificity with 80% power. We will estimate measures of effect by comparing outcomes in antibiotic arms (combined and individually) to standard-of-care.
ETHICS AND DISSEMINATION


The study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics - Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


The clinical trial is registered with ClinicalTrials.gov, NCT03545373.",2020,"Standard diagnostic algorithms include 'trial-of-antibiotics'-empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a 'rule-out' diagnostic test for tuberculosis.","['Malawian adults (≥18 years) seeking primary care for cough into', 'A three-arm, open-label, RCT randomising (1:1:1']","['azithromycin', 'amoxicillin']","['day 29 incidence of a composite endpoint of either death or hospitalisation or missed tuberculosis diagnosis', 'diagnostic specificity', 'proportion of patients reporting day 8 improvement out of those with negative mycobacteriology (specificity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.354,"Standard diagnostic algorithms include 'trial-of-antibiotics'-empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a 'rule-out' diagnostic test for tuberculosis.","[{'ForeName': 'Titus Henry', 'Initials': 'TH', 'LastName': 'Divala', 'Affiliation': 'TB Centre, London School of Hygiene and Tropical Medicine, London, UK titus.divala@lshtm.ac.uk.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Fielding', 'Affiliation': 'TB Centre, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Sloan', 'Affiliation': 'School of Medicine, University of Saint Andrews, Saint Andrews, Fife, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'French', 'Affiliation': 'Institute of Infection and Global Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Marriott', 'Initials': 'M', 'LastName': 'Nliwasa', 'Affiliation': 'TB Centre, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacPherson', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Chikondi Charity', 'Initials': 'CC', 'LastName': 'Kandulu', 'Affiliation': 'Helse Nord Tuberculosis Initiative, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Lingstone', 'Initials': 'L', 'LastName': 'Chiume', 'Affiliation': 'Helse Nord Tuberculosis Initiative, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Sanderson', 'Initials': 'S', 'LastName': 'Chilanga', 'Affiliation': 'Helse Nord Tuberculosis Initiative, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Masiye John', 'Initials': 'MJ', 'LastName': 'Ndaferankhande', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'TB Centre, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033999']
516,32221151,Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management.,"PURPOSE


To assess the safety of phenylephrine and ketorolac (PE/K) 1.0%/0.3% compared with phenylephrine (PE) 1.0% in children aged 0 to 3 years undergoing cataract surgery. The effect of PE/K to PE on intraoperative pupil diameter and postoperative pain were also compared.
SETTING


Multicenter study in the United States.
DESIGN


Randomized double-masked phase 3 clinical trial.
METHODS


This study was powered to assess safety only. Depending on randomization, 4 mL of PE/K 1.0%/0.3% or PE 1.0% was injected into the surgical irrigation solution. Safety endpoints were assessed up to 90 days postoperatively. From surgical videos, a masked central reader measured the change in pupil diameter from immediately prior to incision to wound closure. Postoperative pain was measured using Alder Hey Triage Pain Score at 3 hours, 6 hours, 9 hours, and 24 hours following wound closure and recorded by parent/caregiver.
RESULTS


Seventy-two patients received masked intervention. There were no notable changes in vital signs or ophthalmological complications in either group. Mean change in pupil diameter was similar between PE/K 1.0%/0.3% and PE 1.0% (mean difference in area under the curve -0.071; P = .599). Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P = .029 and 0.021, respectively).
CONCLUSIONS


PE/K 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery. Postoperative pain levels were lower in the PE/K 1.0%/0.3% group.",2020,"Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P=0.029 and 0.021, respectively).
","['children ages 0 to 3 years undergoing cataract surgery', 'Pediatric Cataract Surgery', 'Seventy-two patients received masked intervention', 'Multicenter study in the United States', 'children and maintained mydriasis during cataract surgery']","['Phenylephrine and ketorolac', 'phenylephrine (PE', 'phenylephrine and ketorolac (PE/K', 'Intracameral Phenylephrine and Ketorolac']","['Mean change in pupil diameter', 'vital signs or ophthalmological complications', 'intraoperative pupil diameter and postoperative pain', 'Alder Hey Triage Pain Score', 'Postoperative pain levels', 'Postoperative ocular pain scores and overall mean scores', 'overall mean scores', 'Postoperative pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0026961', 'cui_str': 'Mydriasis'}]","[{'cui': 'C3833028', 'cui_str': 'Ketorolac / Phenylephrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0330318', 'cui_str': 'Alder'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.30409,"Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P=0.029 and 0.021, respectively).
","[{'ForeName': 'M Edward', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'From the Storm Eye Institute (Wilson, Trivedi), Medical University of South Carolina, Charleston, South Carolina, Indiana University (Plager), Indianapolis, Indiana, USA.'}, {'ForeName': 'Rupal H', 'Initials': 'RH', 'LastName': 'Trivedi', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Plager', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000194']
517,31530081,Does transforaminal lumbar interbody fusion produce leg pain?-Results from a RCT.,"BACKGROUND


Transforaminal lumbar interbody fusion (TLIF) is presently the most used method to achieve lumbar interbody fusion worldwide. The special preparation and cage insertion imply a risk of an undesirable side effect in the form of residual neurogenic pain. This issue has not been investigated prior in a randomized clinical trial (RCT) set up.
AIM


To test whether TLIFs had a higher incidence of leg pain in comparison to a common instrumented posterolateral fusion (PLF) and to test whether a higher occurrence of leg pain on the ipsilateral side in the TLIF group was present.
METHODS


One hundred patients included in a RCT comparing TLIF and PLF fulfilled pain drawings and numeric rating scale (NRS) scale from 0 to 10 preoperatively, after 1 year, and after 2 years. Difference in pain appearance, type, localization, and intensity was compared between groups.
RESULTS


A slightly higher number of patients in the TLIF group reported leg pain at 2 years follow-up: no leg pain, 47% (PLF) and 37% (TLIF); unilateral leg pain, 31% (PLF) and 25% (TLIF); bilateral leg pain, 22% (PLF) and 37% (TLIF),  p  = 0.270. Numbness and pins and needles on the anterior aspect of the lower leg were marked by 10% and 12% of TLIF patients compared to 6% and 4% in PLF patients  p  = 0.498/0.197. The ipsilateral side of cage insertion in the TLIF group was not a place for new leg pain compared to the contralateral side.
CONCLUSION


The special surgical preparation used in TLIFs does not result in the development of new ipsilateral leg pain. However, a higher percentage of the patients in the TLIF group had new leg pain in comparison to PLF after 2 years.",2019,"The ipsilateral side of cage insertion in the TLIF group was not a place for new leg pain compared to the contralateral side.
",['One hundred patients included in a RCT comparing'],"['Transforaminal lumbar interbody fusion (TLIF', 'TLIFs', 'TLIF']","['new leg pain', 'unilateral leg pain', 'TLIF and PLF fulfilled pain drawings and numeric rating scale (NRS) scale', 'bilateral leg pain', 'Numbness and pins and needles on the anterior aspect of the lower leg', 'pain appearance, type, localization, and intensity', 'no leg pain', 'leg pain']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0948842', 'cui_str': 'Unilateral leg pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0222045'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0423572', 'cui_str': 'Pins and needles (finding)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",100.0,0.0386912,"The ipsilateral side of cage insertion in the TLIF group was not a place for new leg pain compared to the contralateral side.
","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Høy', 'Affiliation': 'Department of Orthopedics, Spine Section, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Blazej', 'Initials': 'B', 'LastName': 'Grycel', 'Affiliation': 'Department of Orthopedics, Spine Section, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Andersen', 'Affiliation': 'Department of Orthopedics, Spine Section, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Bünger', 'Affiliation': 'Department of Orthopedics, Spine Section, Aarhus University Hospital, Aarhus, Denmark.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019869469']
518,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
519,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
520,32219623,"Cost-effectiveness of a non-pharmacological treatment vs. ""care as usual"" in day care centers for community-dwelling older people with cognitive impairment: results from the German randomized controlled DeTaMAKS-trial.","BACKGROUND


Cognitive impairment in older adults causes a high economic and societal burden. This study assesses the cost-effectiveness of the multicomponent, non-pharmacological MAKS treatment vs. ""care as usual"" in German day care centers (DCCs) for community-dwelling people with mild cognitive impairment (MCI) or mild to moderate dementia over 6 months.
METHODS


The analysis was conducted from the societal perspective alongside the cluster-randomized controlled, multicenter, prospective DeTaMAKS-trial with waitlist group design. Outcomes were Mini-Mental Status Examination (MMSE) and Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) of 433 individuals in 32 DCCs. Incremental differences in MMSE and ETAM were calculated via a Gaussian-distributed and incremental cost difference via a Gamma-distributed Generalized Linear Model. Cost-effectiveness was assessed via cost-effectiveness planes and cost-effectiveness acceptability curves (CEAC).
RESULTS


At 6 months, MMSE (adjusted mean difference = 0.92; 95% confidence interval (CI): 0.17 to 1.67; p = 0.02) and ETAM (adjusted mean difference = 1.00; CI: 0.14 to 1.85; p = 0.02) were significantly better in the intervention group. The adjusted cost difference was - €938.50 (CI: - 2733.65 to 763.13; p = 0.31). Given the CEAC, MAKS was cost-effective for 78.0% of MMSE and 77.4% for ETAM without a need for additional costs to payers.
CONCLUSIONS


MAKS is a cost-effective treatment to stabilize the ability to perform activities of daily living and cognitive abilities of people with MCI or mild to moderate dementia in German DCCs. Thus, MAKS should be implemented in DCCs.",2020,"At 6 months, MMSE (adjusted mean difference = 0.92; 95% confidence interval (CI):","['community-dwelling older people with cognitive impairment', 'German day care centers (DCCs) for community-dwelling people with mild cognitive impairment (MCI) or mild to moderate dementia over 6\xa0months', 'older adults', 'Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) of 433 individuals in 32 DCCs']","['ETAM', 'non-pharmacological treatment vs. ""care', 'multicomponent, non-pharmacological MAKS treatment vs. ""care']","['Cost-effectiveness', 'cost-effectiveness planes and cost-effectiveness acceptability curves (CEAC', 'cost-effectiveness', 'Mini-Mental Status Examination (MMSE) and Erlangen Test of Activities of Daily Living']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0175952', 'cui_str': 'Day care center (environment)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",,0.179057,"At 6 months, MMSE (adjusted mean difference = 0.92; 95% confidence interval (CI):","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Steinbeisser', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Zentrum München, German Research Center for Environmental Health, Ingolstädter Landstr. 1, 85764, Neuherberg, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Schwarzkopf', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Zentrum München, German Research Center for Environmental Health, Ingolstädter Landstr. 1, 85764, Neuherberg, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Graessel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Center for Health Service Research in Medicine, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Schwabachanlage 6, 91054, Erlangen, Germany. elmar.graessel@uk-erlangen.de.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Seidl', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Zentrum München, German Research Center for Environmental Health, Ingolstädter Landstr. 1, 85764, Neuherberg, Germany.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-020-01175-y']
521,32219705,Does quality of life feedback promote seeking help for undiagnosed cancer?,"PURPOSE


Diagnosing cancer early is an imperative, as help-seeking delays affect survival. Quality of life (QoL) deteriorates after diagnosis, but decline may start when cancer is suspected at the earliest stage of the pathway to treatment. This study examined whether offering guided feedback about personal QoL to adults with potential cancer symptoms, living in deprived communities, changes QoL and promotes help-seeking in primary care.
METHODS


Visitors to a CRUK mobile cancer roadshow were recruited in 43 sites. A prospective longitudinal (2 × 2) repeated-measures design was applied. Where they presented a potential cancer symptom, and were 'signposted' to a GP, they were allocated to a symptom condition, or a lifestyle condition, if seeking cancer risk advice. Randomisation was to an Intervention group, who received feedback about personal QoL results (WHOQOL-BREF and WHOQOL importance measures), or a Control group who assessed QoL without feedback. Depression was screened.
RESULTS


Of 107 participants, the mean age was 53; 50% were women, 57% were without tertiary education, 66% were unemployed and 45% were currently ill. Over 10 weeks, 54% of all those with symptoms sought help from a medical source and 42% specifically from a GP. Thirty-one completed all three assessments. With symptoms present, psychological, social and environmental QoL were poor, becoming poorer over time. When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected. However, feedback increased help-seeking from informal social contacts. Lifestyle groups reported consistently good psychological and social QoL.
CONCLUSION


This early cancer research offers practical and theoretical implications for QoL interventions in deprived communities.",2020,"When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected.","['Visitors to a CRUK mobile cancer roadshow were recruited in 43 sites', 'adults with potential cancer symptoms, living in deprived communities, changes QoL and promotes help-seeking in primary care', '107 participants', 'mean age was 53; 50% were women, 57% were without tertiary education, 66% were unemployed and 45% were currently ill']","['guided feedback about personal QoL', 'feedback about personal QoL results (WHOQOL-BREF and WHOQOL importance measures), or a Control group who assessed QoL without feedback']","['good psychological and social QoL', 'Quality of life (QoL) deteriorates', 'feedback, psychological QoL increased, but GP visits', 'psychological, social and environmental QoL']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",107.0,0.0221673,"When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected.","[{'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Skevington', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK. suzanne.skevington@manchester.ac.uk.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Long', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gartland', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02431-7']
522,32165151,"Subliminal fatty acid-induced gut-brain signals attenuate sensitivity to exteroceptive rewards in food but not in sex or financial domains, in healthy men.","Background Reward sensitivity can generalize across domains, but evidence for generalization of suppressive reward-related stimulation is sparse, especially in the context of interoceptive nutrient-related stimuli. We hypothesized that subliminal fatty acid-induced gut-brain signals could attenuate sensitivity to exteroceptive rewards, not only within the food domain but also across domains. Method Intragastric infusion of 2.5 g lauric acid (fat condition) or saline (saline condition) was administered to 59 healthy heterosexual male volunteers in a blinded fashion. To assess whether the resulting interoceptive signals attenuate reward sensitivity within the food domain, participants rated the palatability of food images and performed a progressive ratio task. To assess whether such attenuation effect generalizes to the sexual and financial reward domains, participants rated attractiveness of female face images and performed an intertemporal monetary choice task. Results Participants' ratings of food images were lower (F 1, 172  = 4.51, p = 0.035, Cohen's d: -0.20) in the fat condition. The progressive ratio task terminated earlier in the fat condition compared to saline (F 1, 52  = 4.17, p = 0.046, odds ratio = 0.31, 95%CI [0.11, 0.98]). Participants' ratings of female face images did not differ between conditions (F 1, 172  = 1.85, p = 0.19, Cohen's d: -0.15). Moreover, the monetary discounting rate did not differ significantly between conditions. Conclusion Overall, these findings suggest a domain-specific effect of subliminal fatty acid infusion on decreasing reward sensitivity.",2020,"Results Participants' ratings of food images were lower (F 1, 172  = 4.51, p = 0.035, Cohen's d:","['59 healthy heterosexual male volunteers in a blinded fashion', 'healthy men']","['Subliminal fatty acid-induced gut-brain signals', 'lauric acid (fat condition) or saline (saline condition']","['reward sensitivity', 'monetary discounting rate', 'progressive ratio task', 'ratings of food images']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0023139', 'cui_str': 'lauric acid'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",,0.149504,"Results Participants' ratings of food images were lower (F 1, 172  = 4.51, p = 0.035, Cohen's d:","[{'ForeName': 'Dongxing', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders, KU Leuven (TARGID), KU Leuven, B-3000, Leuven, Belgium; Institute for Diabetes Research and Metabolic Diseases (IDM) of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Mehrad', 'Initials': 'M', 'LastName': 'Moeini-Jazani', 'Affiliation': 'Faculty of Economics and Business, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Weltens', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders, KU Leuven (TARGID), KU Leuven, B-3000, Leuven, Belgium.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Van Gils', 'Affiliation': 'IMEC, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders, KU Leuven (TARGID), KU Leuven, B-3000, Leuven, Belgium.'}, {'ForeName': 'Luk', 'Initials': 'L', 'LastName': 'Warlop', 'Affiliation': 'BI Norwegian Business School,, Department of Marketing, Nydalsveien 37, N-0484, Oslo, Norway. Electronic address: luk.warlop@bi.no.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders, KU Leuven (TARGID), KU Leuven, B-3000, Leuven, Belgium. Electronic address: lukas.vanoudenhove@kuleuven.be.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112861']
523,32090783,Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan.,"BACKGROUND


The Thinking Healthy Programme (THP) is recommended to treat perinatal depression in resource-limited settings, but scale-up is hampered by a paucity of community health workers. THP was adapted for peer-delivery (THPP) and evaluated in two randomized controlled trials in India and Pakistan. Our aim was to estimate the effectiveness of THPP on maternal outcomes across these two settings, and evaluate effect-modification by country and other pre-defined covariates.
METHODS


Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to THPP plus enhanced usual care (EUC) or EUC-only. Primary outcomes were symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth. Secondary outcomes included further measures of depression, disability and social support at 3 and 6 months post-childbirth.
RESULTS


Among 850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up. Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only. There was a greater intervention effect on remission among women with short chronicity of depression, and those primiparous. There were beneficial intervention effects across multiple secondary outcomes.
LIMITATIONS


The trials were not powered to assess effect-modifications. 10-20% of participants were missing outcome data.
CONCLUSIONS


This pooled analysis demonstrates the effectiveness, acceptability and feasibility of THPP, which can be scaled-up within a stepped-care approach by engaging with the existing health care systems and the communities to address the treatment gap for perinatal depression in resource-limited settings.",2020,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","['perinatal depression delivered through peers', 'Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to', '850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up']","['THPP plus enhanced usual care (EUC) or EUC-only', 'THPP', 'Thinking Healthy Programme (THP', 'India and Pakistan', 'THP', 'Thinking Healthy Programme']","['lower symptom severity (PHQ-9 score', 'symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth', 'depression, disability and social support at 3 and 6 months post-childbirth']","[{'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0060462', 'cui_str': 'flopropione'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0217641', 'cui_str': '4-Pyrimidinecarboxylic acid, 1,4,5,6-tetrahydro-2-methyl-'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0037438'}]",850.0,0.199711,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: fiona.vanobberghen@swisstph.ch.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Fuhr', 'Affiliation': 'Faculty of Public Health and Policy, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan; Health Services Academy, Islamabad, Pakistan.'}, {'ForeName': 'Ejma', 'Initials': 'E', 'LastName': 'Afonso', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ikhlaq', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Najia', 'Initials': 'N', 'LastName': 'Atif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Tayyaba', 'Initials': 'T', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Bilal', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Aveena', 'Initials': 'A', 'LastName': 'De Sa', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': ""D'Souza"", 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Akankasha', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Korgaonkar', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Lazarus', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Rakshanda', 'Initials': 'R', 'LastName': 'Liaqat', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sharif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Weobong', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Faculty of Epidemiology and Population Health, Department of Population Health, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaidi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Shaffaq', 'Initials': 'S', 'LastName': 'Zuliqar', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.110']
524,32058642,Impact of Vancomycin-Induced Changes in the Intestinal Microbiota on the Pharmacokinetics of Simvastatin.,"The pharmacokinetic (PK) properties of drugs are affected in several ways by interactions with microbiota. The aim of this study was to investigate the effects of oral vancomycin on the gut microbiota and, consequently, on the PKs of simvastatin. An open-label, single arm, sequential crossover study was conducted in six healthy Korean male subjects. After 6 days on a control diet, simvastatin 40 mg was orally administered to the subjects before and after 1 week of oral vancomycin treatment. Blood samples for PK analysis and fecal samples for metagenomic and metabolomic analyses were collected. After vancomycin treatment, the richness of microbiota considerably decreased, and the composition was altered. In particular, the relative abundance of Bacteroidetes decreased, whereas that of proteobacteria increased. In addition, changes in fecal metabolites, including D-glucuronic acid, were observed. However, systemic exposure of simvastatin was not changed whereas that of hydroxysimvastatin showed a tendency to increase. The relationship between the change of PKs of simvastatin and the change of gut microbiota and fecal metabolites were not clearly observed.",2020,"In particular, the relative abundance of Bacteroidetes decreased, while that of Proteobacteria increased.",['six healthy Korean male subjects'],"['vancomycin treatment', 'control diet, simvastatin', 'vancomycin', 'simvastatin']","['gut microbiota and fecal metabolites', 'fecal metabolites, including D-glucuronic acid', 'relative abundance of Bacteroidetes', 'richness of microbiota']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0982112', 'cui_str': 'D-GLUCURONIC ACID'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0995456', 'cui_str': 'Bacteroidetes'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",6.0,0.0199359,"In particular, the relative abundance of Bacteroidetes decreased, while that of Proteobacteria increased.","[{'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Sunwoo', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Sang Chun', 'Initials': 'SC', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Andrew HyoungJin', 'Initials': 'AH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Joo-Youn', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}]",Clinical and translational science,['10.1111/cts.12761']
525,31896735,Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial.,"OBJECTIVES


Up to 77% of patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but traditional positional therapy (PT) methods have failed as they were poorly tolerated. New convenient vibratory PT devices have been invented but while recent studies suggest high treatment efficacy and adherence, there are no published data comparing these devices directly with continuous positive airway pressure (CPAP). Our objective is to evaluate if a convenient vibratory PT device is non-inferior to CPAP in POSA treatment.
METHODS


In this crossover randomised controlled trial, we enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10). POSA diagnosis was based on: (1) total Apnoea/Hypopnoea Index (AHI)>10/hour and non-supine AHI<10/hour (2) supine AHI≥2 × non-supine AHI. Patients used their initial allocated devices (PT or CPAP) for 8 weeks before crossing to the alternative intervention after a 1 week washout. The primary aim is to measure changes in ESS between the two treatments. Secondary outcomes include sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512).
RESULTS


40 patients completed the trial between April 2017 and December 2018. Difference in ESS after 8 weeks of device use (PT minus CPAP) was 2.0 (95% CI 0.68 to 3.32), exceeding our predetermined non-inferiority margin of 1.5. AHI on CPAP was lower than with PT (4.0±3.2 vs 13.0±13.8 events/hour, respectively, p=0.001), although both were lower than at baseline. Time spent supine was significantly lower with PT than CPAP (p<0.001). 60% of patients preferred CPAP, 20% preferred PT, while 20% preferred neither device.
CONCLUSIONS


The non-inferiority ESS endpoint for PT compared with CPAP was not met and the results were inconclusive. Future trials with larger sample sizes or in less symptomatic patients are warranted to provide further insight into the role of these new vibratory PT devices.",2020,Time spent supine was significantly lower with PT than CPAP (p<0.001).,"['40 patients completed the trial between April 2017 and December 2018', 'patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but', 'positional OSA', 'enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10']","['initial allocated devices (PT or CPAP', 'convenient vibratory positional device to CPAP', 'traditional positional therapy (PT', 'CPAP']","['Time spent supine', 'AHI on CPAP', 'ESS', 'total Apnoea/Hypopnoea Index (AHI)>10/hour', 'sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C3831015', 'cui_str': 'Convenient (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",40.0,0.0527833,Time spent supine was significantly lower with PT than CPAP (p<0.001).,"[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore mok.yingjuan@singhealth.com.sg.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Pon Poh', 'Initials': 'PP', 'LastName': 'Hsu', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Seow', 'Affiliation': 'Allied Health Division, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Singapore, Singapore, Singapore.'}, {'ForeName': 'Hang Siang', 'Initials': 'HS', 'LastName': 'Wong', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Poh', 'Affiliation': 'Allied Health Division, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Keith K H', 'Initials': 'KKH', 'LastName': 'Wong', 'Affiliation': 'Department of Respiratory & Sleep Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}]",Thorax,['10.1136/thoraxjnl-2019-213547']
526,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
527,32219557,"Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity in Japanese subjects: results from a randomized, double-blind, placebo-controlled study (J-PURE).","BACKGROUND


Upper-limb spasticity frequently occurs after stroke and there is a clinical need for more effective therapies. The Phase III J-PURE study assessed the efficacy and safety of incobotulinumtoxinA up to 400 U for post-stroke upper-limb spasticity in Japan.
METHODS


In the 12-week main period (MP) of this double-blind, placebo-controlled study, Japanese subjects with upper-limb spasticity received one injection cycle of incobotulinumtoxinA 400 U, 250 U, or matching placebo. Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40 weeks). The primary objective was to establish the efficacy of a single incobotulinumtoxinA injection using the Modified Ashworth Scale (MAS) wrist score. Secondary efficacy outcomes and safety were also assessed.
RESULTS


Among 100 treated subjects, AUCs for incobotulinumtoxinA 400 and 250 U were significantly different versus placebo (p = 0.0014 and p = 0.0031, respectively) for change from baseline in MAS wrist score to the end of the MP, with similar results from baseline to week 4. IncobotulinumtoxinA 400 U was superior versus placebo across other spasticity patterns and at most study visits. Improvements were maintained throughout the OLEX period. Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively). IncobotulinumtoxinA was well tolerated up to 52 weeks, with no unexpected adverse events.
CONCLUSION


IncobotulinumtoxinA reduced (pathologically) increased muscle tone, improved functionality and was well tolerated in Japanese subjects with post-stroke upper-limb spasticity.",2020,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","['Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40\xa0weeks', 'Japanese subjects with post-stroke upper-limb spasticity', 'Japanese subjects', 'Japan', 'Japanese subjects with upper-limb spasticity']","['incobotulinumtoxinA', 'single incobotulinumtoxinA injection', 'placebo', 'IncobotulinumtoxinA 400 U was superior versus placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA 400 U, 250 U, or matching placebo']","['Efficacy and safety', 'efficacy and safety', 'Modified Ashworth Scale (MAS) wrist score', 'muscle tone, improved functionality and was well tolerated', 'MAS wrist score', ""Disability Assessment Scale and Investigator's Clinical Global Impression scores""]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.358522,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Masakado', 'Affiliation': 'Department of Rehabilitation Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunitsugu', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Department of Rehabilitation Medicine, Tokyo Bay Rehabilitation Hospital, Chiba, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Rehabilitation Medicine, Hospital of the University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Saitoh', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kaji', 'Affiliation': 'Department of Neurology, Tokushima University Hospital, Tokushima City, Tokushima, Japan. rkaji@tokushima-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09777-5']
528,32219973,Immediate Effects of the Combination of Interferential Therapy Parameters on Chronic Low Back Pain: A Randomized Controlled Trial.,"OBJECTIVES


To compare the immediate analgesic effects of 2 kHz or 4 kHz interferential current (IFC) with different amplitude-modulated frequencies (AMFs) (2 Hz or 100 Hz) on chronic low back pain (CLBP).
DESIGN


Three-arm double-blinded randomized controlled trial.
SETTING


Primary care.
PARTICIPANTS


175 patients (19 to 60 years of age, 105 female) with CLBP.
INTERVENTIONS


One session of IFC: Interferential group (GI): GI2 kHz/100 Hz, GI2 kHz/2 Hz, GI4  kHz/100 Hz, GI4 kHz/2 Hz, or placebo.
MAIN OUTCOMES MEASURES


Pain intensity by numerical rating scale of pain (NRS), McGill Pain Questionnaire (MPQ), and algometry.
RESULTS


There was a significant difference in NRS scores (P < 0.05) in the GI2 kHz/2 Hz, GI4 kHz/2 Hz, and GI4 kHz/100 Hz groups compared with those of the placebo group (PG), and a significant difference in MPQ scores in the GI4 kHz/2 Hz and GI4 kHz/100 Hz groups compared with those of the PG. In algometry, only the GI4 kHz/100 Hz group showed a significant difference (by 2 points in the lumbar region) compared with the PG. Of the carrier frequencies, an IFC of 4 kHz showed more effective results, although no significant difference was noted between the AMFs.
CONCLUSION


An IFC with a carrier frequency of 4 kHz and an AMF of 100 Hz provide immediate analgesic effects in individuals with CLBP.
CLINICAL TRIAL REGISTRATION NUMBER


RBR-59YGRB.",2020,"there was a significant difference in NRS (p<0.05) of GI2kHz/2Hz, GI4kHz/2Hz, and GI4kHz/100Hz groups, compared with that of PG and in MPQ of GI4kHz/2Hz and GI4kHz/100Hz groups, compared with that of PG.","['175 patients (aged 19-60 years, 105 female) with CLBP', 'chronic low back pain', 'individuals with CLBP']","['IFC: GI2kHz/100Hz, GI2kHz/2Hz, GI4kHz/100Hz, GI4kHz/2Hz, or placebo (PG', 'GI4kHz/100Hz', '2 kHz or 4 kHz interferential current (IFC) with different amplitude-frequency modulations (AMFs) (2Hz or 100Hz', 'interferential therapy parameters']","['chronic low back pain (CLBP', 'pain intensity by numerical rating scale of pain (NRS), McGill pain questionnaire (MPQ), and algometry']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0556898', 'cui_str': 'Interferential therapy (regime/therapy)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}]",175.0,0.281098,"there was a significant difference in NRS (p<0.05) of GI2kHz/2Hz, GI4kHz/2Hz, and GI4kHz/100Hz groups, compared with that of PG and in MPQ of GI4kHz/2Hz and GI4kHz/100Hz groups, compared with that of PG.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Almeida', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Luis Henrique', 'Initials': 'LH', 'LastName': 'Paladini', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'RacieleIvandra Guarda', 'Initials': 'RG', 'LastName': 'Korelo', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Liebano', 'Affiliation': 'Physiotherapy Department, Universidade Federal de São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Ana Carolina Brandt', 'Initials': 'ACB', 'LastName': 'de Macedo', 'Affiliation': 'Department of Prevention and Rehabilitation in Physiotherapy, Universidade Federal do Paraná, Curitiba, Brazil.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12888']
529,32220129,Outcomes With the Use of Bag-Valve-Mask Ventilation During Out-of-hospital Cardiac Arrest in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


While emergency medical services (EMS) often use endotracheal intubation (ETI) or supraglottic airways (SGA), some patients receive only bag-valve-mask (BVM) ventilation during out-of-hospital cardiac arrests (OHCA). Our objective was to compare patient characteristics and outcomes for BVM ventilation to advanced airway management (AAM) in adults with OHCA.
METHODS


Using data from the Pragmatic Airway Resuscitation Trial, we identified patients receiving AAM (ETI or a SGA), BVM ventilation only (BVM-only), and BVM ventilation as a rescue after at least one failed attempt at advanced airway placement (BVM-rescue). The outcomes were return of spontaneous circulation (ROSC), 72-hour survival, survival to hospital discharge, neurologically intact survival (Modified Rankin Scale ≤ 3), and the presence of aspiration on a chest radiograph. Comparisons were made using generalized mixed-effects models while adjusting for age, sex, initial rhythm, EMS-witnessed status, bystander cardiopulmonary resuscitation, response time, study cluster, and advanced life support first on scene.
RESULTS


Of 3,004 patients enrolled, there were 282 BVM-only, 2,129 AAM, and 156 BVM-rescue patients with complete covariates. Shockable initial rhythms (34% vs. 18.6%) and EMS-witnessed arrests (21.6% vs. 11.3%) were more likely in BVM-only than AAM but similar between BVM-rescue and AAM. Compared to AAM, BVM-only patients had similar ROSC (odds ratio [OR] = 1.29, 95% confidence interval [CI] = 0.96 to 1.73), but higher 72-hour survival (OR = 1.96, 95% CI = 1.42 to 2.69), survival to discharge (OR = 4.47, 95% CI = 3.03 to 6.59), and neurologically intact survival (OR = 7.05, 95% CI = 4.40 to 11.3). Compared to AAM, BVM-rescue patients had similar ROSC (OR = 0.73, 95% CI = 0.47 to 1.12) and 72-hour survival (OR = 1.08, 95% CI = 0.66 to 1.77) but higher survival to discharge (OR = 2.15, 95% CI = 1.17 to 3.95) and neurologically intact survival (OR = 2.64, 95% CI = 1.20 to 5.81). Aspiration incidence was similar.
CONCLUSIONS


Bag-valve-mask-only ventilation is associated with improved OHCA outcomes. Despite similar rates of ROSC and 72-hour survival, BVM-rescue ventilation was associated with improved survival to discharge and neurologically intact survival compared to successful AAM.",2020,"Despite similar rates of ROSC and 72-hour survival, BVM-rescue ventilation was associated with improved survival to discharge and neurologically intact survival compared to successful AAM.","['adults with OHCA', '3,004 patients enrolled, there were 282 BVM-only, 2,129 AAM, and 156 BVM-rescue patients with complete covariates', 'patients receiving AAM (ETI or a SGA), BVM ventilation only (BVM-only), and BVM ventilation as a rescue after at least one failed attempt at advanced airway placement (BVM-rescue']","['BVM ventilation to advanced airway management (AAM', 'Bag-Valve-Mask Ventilation', 'bag-valve-mask (BVM) ventilation', 'endotracheal intubation (ETI) or supraglottic airways (SGA', 'Bag-valve-mask-only ventilation']","['ROSC and 72-hour survival, BVM-rescue ventilation', 'OHCA outcomes', 'survival to discharge and neurologically intact survival', 'return of spontaneous circulation (ROSC), 72-hour survival, survival to hospital discharge, neurologically intact survival (Modified Rankin Scale\xa0≤\xa03), and the presence of aspiration on a chest radiograph', 'Aspiration incidence', 'Shockable initial rhythms', '72-hour survival', 'neurologically intact survival', 'survival to discharge']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0150126', 'cui_str': 'Airway Control'}, {'cui': 'C1960845', 'cui_str': 'Bag valve mask ventilation (procedure)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic (qualifier value)'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",3004.0,0.145676,"Despite similar rates of ROSC and 72-hour survival, BVM-rescue ventilation was associated with improved survival to discharge and neurologically intact survival compared to successful AAM.","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Stephens', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Texas Southwest Medical Center, Dallas, TX.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'University of Texas Southwest Medical Center, Dallas, TX.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Juan C J', 'Initials': 'JCJ', 'LastName': 'Puyana', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13927']
530,31269801,"Effectiveness of an HIV-risk reduction intervention to reduce HIV transmission among serodiscordant couples in Durban, South Africa. A randomized controlled trial.","Lack of condom use by married or cohabiting couples in populations with high rates of HIV infection has become a significant public health issue. This study investigated whether an HIV risk-reduction intervention (RRI) would increase condom use when delivered to serodiscordant couples as a unit. Of the 62 couples that were screened, 30 serodiscordant couples were enrolled in the study, and randomized 2:1 to an immediate intervention-waitlist control study. The 12-week intervention focused on communication, problem-solving, and negotiation skills. Participants were assessed at baseline, three and six months after the intervention. The main outcome measures were consistent condom use, HIV seroconversion and fidelity to the programme. The use of condoms increased for both the intervention and control groups after receiving a 12-week RRI. Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts ( p  = 0.0119) between the control and intervention groups, the later showing an increase in condom use. No seroconversion was detected, and the overall retention rate of participants was 83.33%. Counselling heterosexual couples as a unit prompted an increase in condom use, but sustained condom use remains a challenge.",2020,"Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts ( p  = 0.0119) between the control and intervention groups, the later showing an increase in condom use.","['62 couples that were screened, 30 serodiscordant couples', 'serodiscordant couples in Durban, South Africa', 'Counselling heterosexual couples']","['HIV-risk reduction intervention', 'communication, problem-solving, and negotiation skills', 'HIV risk-reduction intervention (RRI', 'immediate intervention-waitlist control study']","['overall retention rate', 'mean proportion of condom-protected sex acts', 'HIV transmission', 'condom use, HIV seroconversion and fidelity to the programme']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]",30.0,0.0682837,"Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts ( p  = 0.0119) between the control and intervention groups, the later showing an increase in condom use.","[{'ForeName': 'Sibongile', 'Initials': 'S', 'LastName': 'Mashaphu', 'Affiliation': 'School of Clinical Medicine, University of KwaZulu-Natal, College of Health Sciences, Durban, South Africa.'}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Wyatt', 'Affiliation': 'Department of Psychiatry and Bio-Behavioural, Sciences University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Muyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Bio-Behavioural, Sciences University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Thuli', 'Initials': 'T', 'LastName': 'Mthiyane', 'Affiliation': 'South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Honghu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry and Bio-Behavioural, Sciences University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Exnevia', 'Initials': 'E', 'LastName': 'Gomo', 'Affiliation': 'School of Nursing and Public Health, University of KwaZulu-Natal, College of Health Sciences, Durban, South Africa.'}]",AIDS care,['10.1080/09540121.2019.1634785']
531,32215897,Strength Training Induces Greater Increase in Handgrip Strength than Wrestling Training per se.,"This study investigated the effectiveness of a specialized strength training program on maximal handgrip strength in young wrestlers. 72 young wrestlers (36 children: 8-10 years-old and 36 adolescents:13-15 years-old) participated in the present study. Both age-categories were assigned into a training group (18 children and 18 adolescents) and a control group (18 children and 18 adolescents). The training groups, in conjunction with the wrestling training performed a 4-month (2 sessions/week) specialized handgrip training program. Maximal handgrip strength was evaluated pre, at the intermediate (2 months) and at the completion of the program (4 months). Maximal handgrip strength values increased during the intermediate and post-training measurements compared to pre-training measurement in training and control groups (p<0.001). No significant differences were observed on pre-training and intermediate measurements between groups, while significant differences were observed during the post-training measurement. Training group exhibited significantly (p<0.01) greater maximal handgrip strength values than the control group irrespective of age-category and hand-preference. A 4-month handgrip strength training program, incorporated into the conventional wrestling training, provokes greater adaptations in maximal handgrip strength than the wrestling training per se. For greater handgrip training adaptations are required more than 14 specialized handgrip training-sessions.",2020,Maximal handgrip strength values increased during the intermediate and post-training measurements compared to pre-training measurement in training and control groups (p<0.001).,"['72 young wrestlers (36 children: 8-10 years-old and 36 adolescents:13-15 years-old) participated in the present study', 'Both age-categories were assigned into a training group (18 children and 18 adolescents) and a control group (18 children and 18 adolescents', 'young wrestlers']","['Strength Training', 'handgrip strength training program', 'specialized strength training program', 'specialized handgrip training program']","['maximal handgrip strength', 'pre-training and intermediate measurements', 'Maximal handgrip strength', 'Maximal handgrip strength values', 'maximal handgrip strength values', 'Handgrip Strength']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",72.0,0.00858051,Maximal handgrip strength values increased during the intermediate and post-training measurements compared to pre-training measurement in training and control groups (p<0.001).,"[{'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Karatrantou', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Katsoula', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Tsiakaras', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Ioakimidis', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Gerodimos', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}]",International journal of sports medicine,['10.1055/a-1128-7166']
532,32214062,Task-based mirror therapy enhances the upper limb motor function in subacute stroke patients: a randomized control trial.,"BACKGROUND


The improvement of the upper limb disability, which is mainly caused by stroke, is still one of the rehabilitation treatment challenges. However, the effectiveness of task-based mirror therapy (TBMT) on subacute stroke with moderate and severe upper limb impairment has not been deeply explored.
AIM


The purpose of this study was to investigate the effects of TBMT, in comparison to occupational therapy, in moderate and severe upper limb impairment by analyzing the motor function and activities of daily living in subacute stroke patients.
DESIGN


A randomized controlled trial.
SETTING


Rehabilitative inpatient unit.
POPULATION


Thirty patients with moderate and severe-subacute stroke recruited from the Second Affiliated Hospital of Chongqing Medical University have been randomly divided into two groups; the task-based mirror therapy group (N.=15) and the control group (N.=15).
METHODS


The first group received TBMT while the control group only underwent only occupational therapy without a mirror utilization. Taking into consideration that both groups received conventional therapy. The intervention time was equal for both groups consisting of 25 minutes per day for 25 days. Fugl-Meyer Assessment (FMA), Brunnstrom Assessment (BRS), Modified Barthel Index (MBI), and Modified Ashworth Scale (MAS) were used to assess the outcomes for this study.
RESULTS


After 25 sessions of treatment, the patients in both groups have shown-improvement in the activates of daily living, motor recovery, and motor function. No significant differences between the two groups were observed on BRS and MBI. However, interestingly, the results of the TBMT group were significantly better than the control group in FMA (P<0.05) and certain aspects of MAS (elbow flexion, wrist flexion, wrist extension, and fingers extension with P<0.05).
CONCLUSIONS


This study shows that the combination of conventional rehabilitation treatment and TBMT is an effective way to improve the functional recovery in the upper limb stroke patients.
CLINICAL REHABILITATION IMPACT


TBMT is a therapeutic technique that can be used in subacute stroke patients with moderate and severe upper limb impairment.",2020,"After 25 sessions of treatment, the patients in both groups have shown improvement in the activates of daily living, motor recovery, and motor function.","['upper limb stroke patients', 'Rehabilitative inpatient unit', 'subacute stroke patients with moderate and severe upper limb impairment', '30 patients with moderate and severe subacute stroke recruited from the Second Affiliated Hospital of Chongqing Medical University', 'subacute stroke patients', 'subacute stroke with moderate and severe upper limb impairment']","['occupational therapy without a mirror utilization', 'Task-Based Mirror Therapy (TBMT', 'TBMT', 'Task-Based Mirror Therapy', 'Task-based mirror therapy', 'conventional rehabilitation treatment and TBMT']","['activates of daily living, motor recovery, and motor function', 'certain aspects of MAS (elbow flexion, wrist flexion, wrist extension, and fingers extension with P< 0.05', 'Fugl-Meyer Assessment (FMA), Brunnstrom Assessment(BRS), Modified Barthel Index (MBI), and Modified Ashworth Scale (MAS', 'BRS and MBI']","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}]",30.0,0.0224969,"After 25 sessions of treatment, the patients in both groups have shown improvement in the activates of daily living, motor recovery, and motor function.","[{'ForeName': 'Hamza Y', 'Initials': 'HY', 'LastName': 'Madhoun', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China - 303518@cqmu.edu.cn.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Cuijuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lehua', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06070-0']
533,32217780,Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea.,"BACKGROUND


Obesity hypoventilation syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities.
OBJECTIVES


We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure.
METHODS


Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed.
RESULTS


In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91-3.14) years for NIV group and 3.00 (2.92-3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups.
CONCLUSION


CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA.
TRIAL REGISTRATION NUMBER


NCT01405976.",2020,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"['363 patients were selected, 215 were randomised and 202 were available for the analysis', 'obesity hypoventilation syndrome with severe obstructive sleep apnoea', 'patients with OHS with severe OSA', 'patients with OHS with severe obstructive sleep apnoea (OSA']","['CPAP', 'non-invasive ventilation (NIV) or CPAP', 'NIV versus CPAP', 'positive airway pressure modalities']","['mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs', 'Costs and effectiveness', 'hospital stay', 'mean (SD) Bayesian estimated hospital days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0031880', 'cui_str': 'Obesity Hypoventilation Syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",363.0,0.132362,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain fmasa@separ.es.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Instituto Universitario deInvestigación Biosanitaria de Extremadura (INUBE), Romero, Auxiliadora.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Gómez de Terreros Caro', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': 'M-Ángeles', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gómez-García', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Francisco-José', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-Peñafiel', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213622']
534,32149451,"Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE).","OBJECTIVES


Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder currently approved in the United States and European Union for treatment of hyperkalemia. This pilot evaluation explored the efficacy of SZC with insulin and glucose as hyperkalemia treatment in the emergency department (ED).
METHODS


This exploratory, phase II, multicenter, randomized, double-blind, placebo-controlled study (NCT03337477) enrolled adult ED patients with blood potassium ≥ 5.8 mmol/L. Patients were randomized 1:1 to receive SZC 10 g or placebo, up to three times during a 10-hour period, with insulin and glucose. The primary efficacy outcome was the mean change in serum potassium (sK +  ) from baseline until 4 hours after start of dosing.
RESULTS


Overall, 70 patients were randomized (SZC n = 33, placebo n = 37), of whom 50.0% were male. Their mean (± standard deviation [±SD]) age was 59.0 (±13.8) years and mean initial sK +  was similar between groups (SZC 6.4 mmol/L, placebo 6.5 mmol/L). The least squares mean (±SD) sK +  change from baseline to 4 hours was -0.41 (±0.11) mmol/L and -0.27 (±0.10) mmol/L with SZC and placebo, respectively (difference = -0.13 mmol/L, 95% confidence interval [CI] = -0.44 to 0.17). A greater reduction in mean (±SD) sK +  from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (±0.12) versus -0.36 (±0.11) mmol/L (LSM difference = -0.35 mmol/L, 95% CI = -0.68 to -0.02), respectively. A numerically lower proportion of patients in the SZC group required additional potassium-lowering therapy due to hyperkalemia at 0 to 4 hours versus placebo (15.6% vs. 30.6%, respectively; odds ratio = 0.40, 95% CI = 0.09 to 1.77). Comparable proportions of patients experienced adverse events in both treatment groups at 0 to 24 hours.
CONCLUSIONS


This pilot study suggested that SZC with insulin and glucose may provide an incremental benefit in the emergency treatment of hyperkalemia over insulin and glucose alone.",2020,A greater reduction in mean sK +  from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"['enrolled adult ED patients with blood potassium', '70 patients were randomized (SZC n = 33; placebo n = 37), of which 50.0% were male']","['SZC 10 g or placebo', 'Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate', 'SZC with insulin and glucose', 'placebo', 'Sodium zirconium cyclosilicate (SZC', 'SZC and placebo', 'Placebo']","['adverse events', 'additional potassium-lowering therapy due to hyperkalemia', 'mean change in serum potassium (sK +  ', 'mean sK ', 'least squares mean (SD) sK +  change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853173', 'cui_str': 'Blood potassium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",70.0,0.712986,A greater reduction in mean sK +  from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"[{'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Zubaid', 'Initials': 'Z', 'LastName': 'Rafique', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vishnevskiy', 'Affiliation': 'the, First Pavlov State, Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Michelson', 'Affiliation': 'the, Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, TX.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vishneva', 'Affiliation': ""the, Scientific Centre of Children's Health, Russian Academy of Medical Science, Moscow, Russia.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zvereva', 'Affiliation': 'the, Scientific Research Institution for Complex Issues of Cardiovascular Disease, Kemerovo Medical University, Kemerovo, Russia.'}, {'ForeName': 'Rajaa', 'Initials': 'R', 'LastName': 'Nahra', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Dao', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'and the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13954']
535,32217783,Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study.,"In this randomised, crossover trial, 22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1) energy conservation technique (ECT): participants were asked to rest for at least 5 seconds every three steps and (2) control condition: participants climbed the stairs at their own pace. Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time. CLINICAL TRIAL REGISTRATION: NCT03564028.",2020,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","['patients with severe COPD climb stairs', '22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1']","['Energy conservation technique', 'energy conservation technique (ECT']","['dyspnoea', 'Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition', 'total task time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0449910', 'cui_str': 'Test conditions (attribute)'}]","[{'cui': 'C1621943', 'cui_str': 'Energy conservation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0859235', 'cui_str': 'Lower extremities ill feeling of'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",22.0,0.0844287,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium gprieur.kine@gmail.com.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arnol', 'Affiliation': 'ICADOM, AGIR à dom, Meylan, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Quieffin', 'Affiliation': 'Pulmonology department and pulmonary rehabilitation department, Groupe Hospitalier du Havre, 76290 Montivilliers, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Lamia', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'R&D, AGIR à dom, Meylan, France.'}]",Thorax,['10.1136/thoraxjnl-2019-214295']
536,31466618,Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction.,"BACKGROUND


The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial demonstrated that a strategy to ""guide"" application of guideline-directed medical therapy (GDMT) by reducing amino-terminal pro-B-type natriuretic peptide (NT-proBNP) was not superior to GDMT alone.
OBJECTIVES


The purpose of this study was to examine the prognostic meaning of NT-proBNP changes following heart failure (HF) therapy intensification relative to the goal NT-proBNP value of 1,000 pg/ml explored in the GUIDE-IT trial.
METHODS


A total of 638 study participants were included who were alive and had available NT-proBNP results 90 days after randomization. Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality during follow-up and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall scores were analyzed.
RESULTS


A total of 198 (31.0%) subjects had an NT-proBNP ≤1,000 pg/ml at 90 days with no difference in achievement of NT-proBNP goal between the biomarker-guided and usual care arms. NT-proBNP ≤1,000 pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009). Regardless of elevated baseline concentration, an NT-proBNP ≤1,000 pg/ml at 90 days was associated with better outcomes and significantly better KCCQ overall scores (p = 0.02).
CONCLUSIONS


Patients with heart failure with reduced ejection fraction whose NT-proBNP levels decreased to ≤1,000 pg/ml during GDMT had better outcomes. These findings may help to understand the results of the GUIDE-IT trial. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).",2019,pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009).,"['Heart\xa0Failure', 'A total of 638 study participants were included who were alive and had available NT-proBNP results 90\xa0days after randomization']",['guideline-directed medical therapy (GDMT'],"['longer freedom from CV/HF hospitalization or all-cause mortality', 'Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality', 'Cardiomyopathy Questionnaire (KCCQ) overall scores', 'NT-proBNP levels', 'KCCQ overall scores']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",638.0,0.212442,pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009).,"[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: JJanuzzi@partners.org.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University Medical Center, New Haven, Connecticut.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kirkwood F', 'Initials': 'KF', 'LastName': 'Adams', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, California.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Houston-Miller', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Passmore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Center, Fairfax, Virginia.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.06.055']
537,31595867,"Spatial Effects of Permethrin-Impregnated Bed Nets on Child Mortality: 26 Years on, a Spatial Reanalysis of a Cluster Randomized Trial.","In addition to the direct effect of insecticide-treated nets (ITNs), there has been evidence for spatial indirect effects. Spatial analyses in cluster randomized trials (CRTs) are rare, but a large-scale CRT from 1993 was one of the first to conduct a spatial analysis of ITNs in CRTs. We revisit these data by applying a broader range of contemporary spatial methods to further explore spatial spillover. We conducted three analyses: 1) exploratory spatial analysis, considering spatial patterns and spillover in the data; 2) spatial modeling, estimating the intervention effect considering spatial effects; and 3) analysis of distance-based spillover and interaction with the intervention, characterizing the functional distance over which the spillover effect was present. There were consistent indications of spatial patterns from the exploratory analysis. Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data. There was strong evidence of a spatial spillover effect: for every additional 100 m that a control household was from an intervention household (and vice versa), the standardized mortality ratio (SMR) increased by 1.7% (SMR 1.017, 95% credible interval 1.006-1.026). Despite evidence of a spatial spillover effect, the conclusions of the trial remain unaffected by spatial model specifications. Use of ITNs was clearly beneficial for individuals, and there was compelling evidence that they provide an indirect benefit to individuals living nearby. This article demonstrates the extra utility that spatial methods can provide when analyzing a CRT.",2019,"Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data.",[],"['Permethrin-Impregnated Bed Nets', 'insecticide-treated nets (ITNs']","['standardized mortality ratio (SMR', 'Child Mortality']",[],"[{'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0021576', 'cui_str': 'Insecticides'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0008083', 'cui_str': 'Child Mortality'}]",,0.184522,"Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data.","[{'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jarvis', 'Affiliation': 'MRC London Hub for Trials Methodology Research, London, United Kingdom.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Multerer', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Binka', 'Affiliation': 'School of Public Health, University of Health and Allied Sciences, Ho, Ghana.'}, {'ForeName': 'W John', 'Initials': 'WJ', 'LastName': 'Edmunds', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Smith', 'Affiliation': 'University of Basel, Basel, Switzerland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0111']
538,30995174,Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer.,"PURPOSE


The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma.
PATIENTS AND METHODS


A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33-based high-intermediate-risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles.
RESULTS


The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9%  v  4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated.
CONCLUSION


Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.",2019,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","['High-Intermediate and High-Risk Early Stage Endometrial Cancer', 'The median age of the 601 patients was 63 years, and 74% had stage I disease', 'high-intermediate and high-risk early-stage endometrial carcinoma', 'eligible patients with endometrial cancer', 'Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage']","['Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin', 'vaginal cuff brachytherapy and chemotherapy (VCB/C', 'pelvic radiation therapy (RT', 'Pelvic RT alone', 'VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin']","['recurrence-free survival (RFS', 'Pelvic or para-aortic nodal recurrences', 'RFS or overall survival', '60-month overall survival', '60-month RFS', 'Vaginal and distant recurrence rates', 'Acute toxicity']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0854674', 'cui_str': 'Brachytherapy to vagina'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.213594,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","[{'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Randall', 'Affiliation': '1 University of Kentucky, Lexington, KY.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'McMeekin', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'von Gruenigen', 'Affiliation': '4 Summa Health System, Akron, OH.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'Catheryn M', 'Initials': 'CM', 'LastName': 'Yashar', 'Affiliation': '5 University of California San Diego, San Diego, CA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': '6 Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': '7 Ohio State University, Columbus, OH.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': '8 Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Burke', 'Affiliation': '9 Mercer University, Savannah, GA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutherford', 'Affiliation': '10 Yale University, New Haven, CT.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""11 Women's Cancer Center of Nevada, Las Vegas, NV.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Terada', 'Affiliation': '12 University of Hawaii, Honolulu, HI.'}, {'ForeName': 'Penny R', 'Initials': 'PR', 'LastName': 'Anderson', 'Affiliation': '13 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Brewster', 'Affiliation': '14 University of North Carolina Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': '15 Loyola University, Chicago, IL.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': '16 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': '17 University of Texas Southwestern Medical Center, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01575']
539,32209647,"A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9).","OBJECTIVE


To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.
RESEARCH DESIGN AND METHODS


This multicenter, double-blind, treat-to-target trial randomized participants to faster aspart ( n  = 546) or IAsp ( n  = 545). All available information, regardless of treatment discontinuation or use of ancillary treatment, was used for evaluation of effect.
RESULTS


Noninferiority for the change from baseline in HbA 1c  16 weeks after randomization (primary end point) was confirmed for faster aspart versus IAsp (estimated treatment difference [ETD] -0.04% [95% CI -0.11; 0.03]; -0.39 mmol/mol [-1.15; 0.37];  P  < 0.001). Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD -0.40 mmol/L [-0.66; -0.14]; -7.23 mg/dL [-11.92; -2.55];  P  = 0.001 for superiority). Change from baseline in self-measured 1-h PPG increment for the mean over all meals favored faster aspart (ETD -0.25 mmol/L [-0.42; -0.09]); -4.58 mg/dL [-7.59; -1.57];  P  = 0.003). The overall rate of treatment-emergent severe or blood glucose (BG)-confirmed hypoglycemia was statistically significantly lower for faster aspart versus IAsp (estimated treatment ratio 0.81 [95% CI 0.68; 0.97]).
CONCLUSIONS


In combination with insulin degludec, faster aspart provided effective overall glycemic control, superior PPG control, and a lower rate of severe or BG-confirmed hypoglycemia versus IAsp in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.",2020,Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD -0.40 mmol/L [-0.66; -0.14]; -7.23 mg/dL,"['Adults With Type 2 Diabetes (Onset 9', 'adults with type 2 diabetes not optimally controlled with a basal-bolus regimen', ' n  = 546) or IAsp ( n  = 545']","['faster aspart', 'Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin', 'insulin aspart (IAsp), both with insulin degludec with or without metformin', 'fast-acting insulin aspart (faster aspart']","['overall rate of treatment-emergent severe or blood glucose (BG)-confirmed hypoglycemia', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0980293,Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD -0.40 mmol/L [-0.66; -0.14]; -7.23 mg/dL,"[{'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Lane', 'Affiliation': 'Mountain Diabetes and Endocrine Centre, Asheville, NC mountaindiabetes@msn.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Favaro', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Rathor', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hak C', 'Initials': 'HC', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Maiken I S', 'Initials': 'MIS', 'LastName': 'Kjærsgaard', 'Affiliation': 'Novo Nordisk A/S, Aalborg, Denmark.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Oviedo', 'Affiliation': 'Santojanni Hospital and CENUDIAB, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': 'Institute of Diabetes Research, Münster, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Senior', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Soto Gonzalez', 'Affiliation': 'Service of Endocrinology and Nutrition, University Hospital of A Coruña, La Coruña, Spain.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Clinical Research Center, Polish Academy of Sciences, and Department of Endocrinology and Diabetology, Central Clinical Hospital of the MSWiA, Warsaw, Poland.'}]",Diabetes care,['10.2337/dc19-2232']
540,32153208,Randomized Feasibility Study of Meditative Practices in Hospitalized Cancer Patients.,"Introduction:  There is limited research regarding the benefits of mind-body practices such as meditation in hospitalized patients with an active diagnosis of any cancer type.  Methods:  We conducted a prospective, randomized, clinical trial (NCT03445572) comparing 2 meditative practices-Isha Kriya (IK) and meditative slow breathing (MSB)-versus wait-list controls in hospitalized cancer patients. Our aim was to determine the feasibility of meditation practice in cancer inpatients. Feasibility was defined as recruitment of more than 50% of the eligible patients approached and at least 60% of the patients having meditated at least 4 days by day 7. Acceptability was assessed on day 7 as a positive response on at least 2 questions on the modified Global Symptom Evaluation (GSE) scale.  Results:  Forty patients (39% of the eligible patients approached) consented to participate in the study and were randomly assigned to the MSB (n = 13), IK (n = 14), or wait-list (n = 13) groups. Of the 27 patients assigned to receive MSB and IK meditations, day 7 data were available for 18 patients. Fifteen of the 18 patients meditated at least once in the first 7 days, and most (12/15) responded positively on the GSE.  Conclusion:  Both IK and MSB meditations were acceptable among the hospitalized cancer patients. Feasibility for enrollment and practice was likely not achieved due to limited uninterrupted time for daily meditation, high levels of morbidity in some participants, and limited research staff support. Shorter term outcomes should be explored in future meditation studies involving hospitalized cancer patients.",2020,Acceptability was assessed on day 7 as a positive response on at least 2 questions on the modified Global Symptom Evaluation (GSE) scale.  ,"['hospitalized cancer patients', 'Results:  Forty patients (39% of the eligible patients approached) consented to participate in the study', '27 patients assigned to receive MSB and IK meditations, day 7 data were available for 18 patients', 'Hospitalized Cancer Patients', 'hospitalized patients with an active diagnosis of any cancer type', 'cancer inpatients']","['MSB', 'meditation practice', 'Meditative Practices', 'meditative practices-Isha Kriya (IK) and meditative slow breathing (MSB)-versus wait-list controls']","['Acceptability', 'Feasibility', 'modified Global Symptom Evaluation (GSE) scale']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0150277'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration (finding)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0222045'}]",,0.119082,Acceptability was assessed on day 7 as a positive response on at least 2 questions on the modified Global Symptom Evaluation (GSE) scale.  ,"[{'ForeName': 'Santhosshi', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lopez', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Manzano', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Williams', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Smitha', 'Initials': 'S', 'LastName': 'Mallaiah', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Amaram', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Balachandar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Integrative cancer therapies,['10.1177/1534735420909903']
541,31738759,"Implementation of guppy fish (Poecilia reticulata), and a novel larvicide (Pyriproxyfen) product (Sumilarv 2MR) for dengue control in Cambodia: A qualitative study of acceptability, sustainability and community engagement.","BACKGROUND


In Cambodia dengue vector control activities are focused on larviciding with temephos and pyrethroid based adulticide sprays to which Aedes have been shown to be increasingly resistant. A cluster randomized trial assessed the impact of using biological control tools (guppy fish, pyriproxyfen (PPF), and Communication for Behavioral Impact (COMBI) activities in combination), which would be used in a value comparison to traditional chemical control tools. Given these new intervention methods, a qualitative assessment was designed in order to represent the quality of understanding, acceptance, and implementation by participants.
METHODOLOGY/PRINCIPAL FINDINGS


A total of 103 participants in 12 Focus Group Discussions (FGDs) and nine In-Depth Interviews (IDIs) were included in the study. The majority of participants in intervention villages (50 out of 80) preferred guppy fish over other vector control methods due to ease of use and rearing, quick reproduction and propensity to eat larvae. A substantial number of participants (11 out of 40) in intervention villages with PPF favored it due to long-lasting effectiveness, lack of smell and easy maintenance. Participants showed high demand for both interventions and were willing to pay between 100-500 riel (0.03-0.13 USD). Nearly all participants perceived that the interventions resulted in a reduction in Aedes mosquitos (both adults and immatures) and dengue cases. The presence of larvae in the water despite the use of PPF was a source of concern for some participants, although this was overcome in some cases with proper health education through health volunteers. Interpersonal communication through health volunteers was the most favorite method of transmitting prevention messages.
CONCLUSIONS/SIGNIFICANCE


The community led COMBI strategy resulted in high acceptance and perceived effectiveness of the interventions in target villages. Health volunteers are an effective and accepted channel of communication to engage communities, disseminate information and promote behavioral change at the household and community level. If shown effective through corresponding entomological surveys, the interventions should be continued and further strengthened to ensure they are accessible, available and affordable.",2019,Nearly all participants perceived that the interventions resulted in a reduction in Aedes mosquitos (both adults and immatures) and dengue cases.,"['103 participants in 12 Focus Group Discussions (FGDs) and nine In-Depth Interviews (IDIs) were included in the study', 'Health volunteers', 'Cambodia']","['biological control tools (guppy fish, pyriproxyfen (PPF', 'guppy fish (Poecilia reticulata), and a novel larvicide (Pyriproxyfen) product (Sumilarv 2MR', 'guppy fish over other vector control methods']",['Aedes mosquitos'],"[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0018398', 'cui_str': 'Lebistes'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0139497', 'cui_str': '4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",[],103.0,0.0581479,Nearly all participants perceived that the interventions resulted in a reduction in Aedes mosquitos (both adults and immatures) and dengue cases.,"[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shafique', 'Affiliation': 'Technical Department, Malaria Consortium, Phnom Penh, Cambodia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Lopes', 'Affiliation': 'Technical Department, Malaria Consortium, Phnom Penh, Cambodia.'}, {'ForeName': 'Dyna', 'Initials': 'D', 'LastName': 'Doum', 'Affiliation': 'Technical Department, Malaria Consortium, Phnom Penh, Cambodia.'}, {'ForeName': 'Vanney', 'Initials': 'V', 'LastName': 'Keo', 'Affiliation': 'Technical Department, Malaria Consortium, Phnom Penh, Cambodia.'}, {'ForeName': 'Ly', 'Initials': 'L', 'LastName': 'Sokha', 'Affiliation': 'National Dengue Control Program, National Center of Parasitology, Entomology, and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'BunLeng', 'Initials': 'B', 'LastName': 'Sam', 'Affiliation': 'National Dengue Control Program, National Center of Parasitology, Entomology, and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Vibol', 'Affiliation': 'Malaria and other Vector-borne and Parasitic diseases, World Health Organization, Phnom Penh, Cambodia.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Liverani', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hii', 'Affiliation': 'Technical Department, Malaria Consortium, Phnom Penh, Cambodia.'}, {'ForeName': 'Leang', 'Initials': 'L', 'LastName': 'Rithea', 'Affiliation': 'National Dengue Control Program, National Center of Parasitology, Entomology, and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Siddhi', 'Initials': 'S', 'LastName': 'Aryal', 'Affiliation': 'Technical Department, Malaria Consortium, Phnom Penh, Cambodia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hustedt', 'Affiliation': 'Technical Department, Malaria Consortium, Phnom Penh, Cambodia.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0007907']
542,31553639,Treatment of Childhood Nasopharyngeal Carcinoma With Induction Chemotherapy and Concurrent Chemoradiotherapy: Results of the Children's Oncology Group ARAR0331 Study.,"PURPOSE


The treatment of childhood nasopharyngeal carcinoma has been adapted from adult regimens; pediatric-specific studies are limited. The ARAR0331 study sought to evaluate the impact of induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR).
PATIENTS AND METHODS


Patients with American Joint Committee on Cancer stages IIb to IV were scheduled to receive three cycles of IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin. Patients with complete or partial response to IC received 61.2 Gy to the nasopharynx and neck, and patients with stable disease received 71.2 Gy.
RESULTS


Between February 2006 and January 2012, 111 patients (75 male) were enrolled. Median age was 15 years, and 46.8% of the patients were African American. After a feasibility analysis, the study was amended to reduce cisplatin to two cycles during CCR. The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively. The 5-year EFS for stages IIb, III, and IV were 100%, 82.8%, and 82.7%, respectively. The 5-year cumulative incidence estimates of local, distant, and combined relapse were 3.7%, 8.7%, and 1.8%, respectively. Patients treated with three versus two CCR cycles of cisplatin had improved 5-year postinduction EFS (90.7%  v  81.2%,  P  = .14).
CONCLUSION


Patients in ARAR0331 were characterized by advanced disease and by a high proportion of black children and adolescents. Treatment with IC and CRT resulted in excellent outcomes. A radiation dose reduction is possible for patients responding to IC. Although the outcomes are comparable, we observed a trend toward decreased EFS for patients assigned to receive fewer doses of cisplatin during CCR.",2019,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","['Childhood Nasopharyngeal Carcinoma', 'Between February 2006 and January 2012, 111 patients (75 male) were enrolled', 'Median age was 15 years, and 46.8% of the patients were African American', 'Patients with American Joint Committee on Cancer stages IIb to IV']","['IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin', 'induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR', 'Induction Chemotherapy and Concurrent Chemoradiotherapy', 'cisplatin', 'IC and CRT']","['5-year cumulative incidence estimates of local, distant, and combined relapse', '5-year event-free survival (EFS) and overall survival estimates', '5-year EFS', '5-year postinduction EFS']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",111.0,0.110512,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Galindo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Krasin', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'M Beth', 'Initials': 'MB', 'LastName': 'McCarville', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hicks', 'Affiliation': ""Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Pashankar', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Alberto S', 'Initials': 'AS', 'LastName': 'Pappo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01276']
543,31196815,Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial.,"BACKGROUND


Sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown beneficial effects on renal outcomes mainly in patients with established atherosclerotic cardiovascular disease. Here we report analyses of renal outcomes with the SGLT2 inhibitor dapagliflozin in the DECLARE-TIMI 58 cardiovascular outcomes trial, which included patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function.
METHODS


In DECLARE-TIMI 58, patients with type 2 diabetes, HbA 1c  6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min were randomly assigned (1:1) to 10 mg dapagliflozin or placebo once daily. A prespecified secondary cardiorenal composite outcome was defined as a sustained decline of at least 40% in estimated glomerular filtration rate [eGFR] to less than 60 mL/min per 1·73m 2 , end-stage renal disease (defined as dialysis for at least 90 days, kidney transplantation, or confirmed sustained eGFR <15mL/min per 1·73 m 2 ), or death from renal or cardiovascular causes; a prespecified renal-specific composite outcome was the same but excluding death from cardiovascular causes. In this renal analysis, we report findings for the components of these composite outcomes, subgroup analysis of these composite outcomes, and changes in eGFR at different timepoints. DECLARE-TIMI 58 is registered with ClinicalTrials.gov, number NCT01730534.
FINDINGS


The trial took place between April 25, 2013, and Sept 18, 2018; median follow-up was 4·2 years (IQR 3·9-4·4). Of the 17 160 participants who were randomly assigned, 8162 (47·6%) had an eGFR of at least 90 mL/min per 1·73 m 2 , 7732 (45·1%) had an eGFR of 60 to less than 90 mL/min per 1·73 m 2 , and 1265 (7·4%) had an eGFR of less than 60 mL/min per 1·73 m 2  at baseline (one participant had missing data for eGFR); 6974 (40·6%) had established atherosclerotic cardiovascular disease and 10 186 (59·4%) had multiple risk factors. As previously reported, the cardiorenal secondary composite outcome was significantly reduced with dapagliflozin versus placebo (hazard ratio [HR] 0·76, 95% CI 0·67-0.87; p<0·0001); excluding death from cardiovascular causes, the HR for the renal-specific outcome was 0·53 (0·43-0·66; p<0·0001). We identified a 46% reduction in sustained decline in eGFR by at least 40% to less than 60 mL/min per 1·73 m 2  (120 [1·4% vs 221 [2·6%]; HR 0·54 [95% CI 0·43-0·67]; p<0·0001). The risk of end-stage renal disease or renal death was lower in the dapagliflozin group than in the placebo group (11 [0·1%] vs 27 [0·3%]; HR 0·41 [95% CI 0·20-0·82]; p=0·012). Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =0·72). 6 months after randomisation, the mean decrease in eGFR was larger in the dapagliflozin group than in the placebo group. The mean change equalised by 2 years, and at 3 and 4 years the mean decrease in eGFR was less with dapagliflozin than with placebo.
INTERPRETATION


Dapagliflozin seemed to prevent and reduce progression of kidney disease compared with placebo in this large and diverse population of patients with type 2 diabetes with and without established atherosclerotic cardiovascular disease, most of whom had preserved renal function.
FUNDING


AstraZeneca.",2019,"Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =","['patients with type 2 diabetes, HbA 1c  6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min', 'patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function', 'patients with type 2 diabetes', 'patients with established atherosclerotic cardiovascular disease', 'patients with type 2 diabetes with and without established atherosclerotic cardiovascular disease, most of whom had preserved renal function', 'Of the 17\u2008160 participants']","['dapagliflozin versus placebo', 'placebo', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'dapagliflozin or placebo', 'SGLT2 inhibitor dapagliflozin', 'dapagliflozin']","['glomerular filtration rate [eGFR', 'multiple risk factors', 'mean decrease in eGFR', 'sustained decline in eGFR', 'cardiorenal and renal-specific composite outcomes', 'risk of end-stage renal disease or renal death', 'eGFR', 'established atherosclerotic cardiovascular disease', 'development and progression of kidney disease', 'presence or absence of established atherosclerotic cardiovascular disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",17160.0,0.449725,"Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =","[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: ofrim@hadassah.org.il.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Eri T', 'Initials': 'ET', 'LastName': 'Kato', 'Affiliation': 'Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30180-9']
544,32212340,"Gastrointestinal Tolerability and Absorption of R- Versus R,S-Lipoic Acid in Progressive Multiple Sclerosis: A Randomized Crossover Trial.","We compared the gastrointestinal (GI) tolerability and assessed for bioequivalent absorption of R-lipoic acid (LA) in people with progressive multiple sclerosis (MS) in a single-center, double-blind, randomized crossover trial. Participants randomly assigned to formulation sequence took 600 mg of R-LA or 1200 mg of a 1:1 racemic R,S-LA mixture in single daily doses for 7 to 10 days, underwent a washout of at least 7 days, and then took the other form of LA for 7 to 10 days. At the end of each period on LA, GI symptoms were assessed with GI questions from the Monitoring of Side Effects Scale. Serum LA concentrations were measured before and 60, 90, 120, 180, and 240 minutes after the first and last day's dose of each form of LA to derive an area under the plasma concentration-time curve (AUC) and maximum serum concentration (C max  ). Twenty participants enrolled (12 women; 15 secondary progressive MS, 5 primary progressive MS; mean age, 59.6 years). Two withdrew early due to symptoms while taking R,S-LA, and one withdrew early while taking R-LA. The mean GI Monitoring of Side Effects Scale score was 1.7 points lower on R-LA than on R,S-LA (P = .069), and there were fewer reports of each GI side effect when taking the R-LA than the R,S-LA (31 vs 60; P = .025). The AUC and C max  for R-LA were bioequivalent for the 2 formulations (90% confidence intervals 97.4% to 99.3% for AUC and 93.4% to 98.2% for C max  ). This study supports that in people with progressive MS, there is better GI tolerability and bioequivalent serum absorption of R-LA when 600 mg of R-LA is taken as R-LA alone than when taken in a 1:1 racemic R,S-LA mixture.",2020,The AUC and C max  for R-LA were bioequivalent for the 2 formulations (90% confidence intervals 97.4% to 99.3% for AUC and 93.4% to 98.2% for C max  ).,"['people with progressive multiple sclerosis (MS', 'people with progressive MS', 'Progressive Multiple Sclerosis', 'Twenty participants enrolled (12 women; 15 secondary progressive MS, 5 primary progressive MS; mean age, 59.6 years']","['R-lipoic acid (LA', 'formulation sequence took 600\xa0mg of R-LA or 1200\xa0mg of a 1:1 racemic R,S-LA mixture']","['Serum LA concentrations', 'gastrointestinal (GI) tolerability', 'LA, GI symptoms', 'mean GI Monitoring of Side Effects Scale score', 'AUC and C max  for R-LA', 'plasma concentration-time curve (AUC) and maximum serum concentration (C max  ', 'Gastrointestinal Tolerability and Absorption of R']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",20.0,0.109965,The AUC and C max  for R-LA were bioequivalent for the 2 formulations (90% confidence intervals 97.4% to 99.3% for AUC and 93.4% to 98.2% for C max  ).,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Cassidy', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Lapidus', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Koop', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Spain', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1605']
545,29901422,Determining if Cerebrospinal Fluid Prevents Recurrence of Chronic Subdural Hematoma: A Multi-Center Prospective Randomized Clinical Trial.,"Over the decades, the problem of postoperative recurrence of chronic subdural hematoma (CSDH) has not been resolved. The objective of our study was to investigate whether the recurrence rate of CSDH is decreased when artificial cerebrospinal fluid (ACF) is used as irrigation solution for CSDH surgery. The present study was a multi-center, prospective, randomized, open parallel group comparison test of patients enrolled from 10 hospitals in Japan. Eligible patients with CSDH were randomly assigned to undergo burr hole drainage with either normal saline (NS) or ACF irrigation. The primary end-point was postoperative recurrence of ipsilateral CSDH. A total of 402 patients with newly diagnosed CSDH were enrolled during the study period. After applying inclusion and exclusion criteria, and taking into consideration cases lost to follow-up, our final study cohorts consisted of 177 ACF patients and 165 NS patients, representing 85.7% of the initial cohort. The overall recurrence rate was 11.4%, occurring in 39 of the 342 analyzed patients during 90 days of follow-up. Recurrence rates in the ACF and NS groups were 11.9% (21 of 177) and 10.9% (18 of 165), respectively. No significant difference was evident between groups (p = 0.87). In addition, no significant difference in time to recurrence was seen between groups (p = 0.74). No serious adverse effects related to irrigation fluid were seen in either group. Regarding the irrigation fluid for CSDH surgery, no differences in recurrence rate or time to recurrence were seen between the ACF and NS groups. However, ACF offers sufficient safety as irrigation fluid for CSDH.",2019,"Regarding the irrigation fluid for CSDH surgery, no differences in recurrence rate or time to recurrence were seen between the ACF and NS groups.","['402 patients with newly diagnosed CSDH', '177 ACF patients and 165 NS patients, representing 85.7% of the initial cohort', 'patients enrolled from 10 hospitals in Japan', 'Chronic Subdural Hematoma', 'Eligible patients with CSDH']","['ACF', 'undergo burr hole drainage with either normal saline (NS) or ACF irrigation', 'artificial cerebrospinal fluid (ACF']","['postoperative recurrence of ipsilateral CSDH', 'Recurrence rates', 'recurrence rate of CSDH', 'time to recurrence', 'recurrence rate or time to recurrence', 'overall recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}]","[{'cui': 'C1171800', 'cui_str': '(18F)ACF'}, {'cui': 'C0040836', 'cui_str': 'Trepanning'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0007807'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",402.0,0.202703,"Regarding the irrigation fluid for CSDH surgery, no differences in recurrence rate or time to recurrence were seen between the ACF and NS groups.","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Toi', 'Affiliation': '1 Department of Neurosurgery, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': '2 Department of Neurosurgery, Brain Research Institute, University of Niigata, Niigata, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Iwama', 'Affiliation': '3 Department of Neurosurgery, Gifu University, Gifu City, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kinouchi', 'Affiliation': '4 Department of Neurosurgery, University of Yamanashi, Yamanashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nakase', 'Affiliation': '5 Department of Neurosurgery, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nozaki', 'Affiliation': '6 Department of Neurosurgery, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ohkuma', 'Affiliation': '7 Department of Neurosurgery, Hirosaki University, Aomori, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Ohta', 'Affiliation': '8 Department of Neurosurgery, Miyakonojo Medical Association Hospital, Miyazaki, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Takeshima', 'Affiliation': '9 Department of Neurosurgery, Miyazaki University, Miyazaki, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Tokumasu', 'Affiliation': '10 The Clinical Research Institute, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Yuhei', 'Initials': 'Y', 'LastName': 'Yoshimoto', 'Affiliation': '11 Department of Neurosurgery, Gunma University, Maebashi, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Uno', 'Affiliation': '1 Department of Neurosurgery, Kawasaki Medical School, Okayama, Japan.'}]",Journal of neurotrauma,['10.1089/neu.2018.5821']
546,31484786,Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial.,"INTRODUCTION


Chronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.
METHODS


Sixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO 2 ) reduction after 6 months NIV, with a non-inferiority margin of 0.4 kPa. Secondary outcomes were health-related quality of life (HRQoL) and costs.
RESULTS


Home NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO 2  change home vs in-hospital: 0.04 kPa (95% CI -0.31 to 0.38 kPa), with both groups showing a PaCO 2  reduction at 6 months compared with baseline (home: from 7.3±0.9 to 6.4±0.8 kPa (p<0.001) and in-hospital: from 7.4±1.0 to 6.4±0.6 kPa (p<0.001)). In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)). Furthermore, home NIV initiation was significantly cheaper (home: median €3768 (IQR €3546-€4163) vs in-hospital: median €8537 (IQR €7540-€9175); p<0.001).
DISCUSSION


This is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.
TRIAL REGISTRATION NUMBER


NCT02652559.",2020,"In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)).","['Sixty-seven stable hypercapnic COPD patients', 'stable hypercapnic COPD patients', 'COPD patients with chronic hypercapnic respiratory failure']","['telemedicine', 'chronic non-invasive ventilation', 'Chronic non-invasive ventilation (NIV']","['daytime arterial carbon dioxide pressure (PaCO 2 ) reduction', 'health-related quality of life (HRQoL) and costs', 'Clinical COPD Questionnaire total score']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1960052', 'cui_str': 'Chronic type II respiratory failure'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",67.0,0.274177,"In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)).","[{'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'Duiverman', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands m.l.duiverman@umcg.nl.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Vonk', 'Affiliation': 'Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gerrie', 'Initials': 'G', 'LastName': 'Bladder', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Joost P', 'Initials': 'JP', 'LastName': 'van Melle', 'Affiliation': 'Thoraxcenter, Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jellie', 'Initials': 'J', 'LastName': 'Nieuwenhuis', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anda', 'Initials': 'A', 'LastName': 'Hazenberg', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Job F M', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Thorax,['10.1136/thoraxjnl-2019-213303']
547,31625966,Nanocrystalline-Coated Silver Dressings for Patients with Type 2 Diabetes after Surgical Coronary Revascularization.,"OBJECTIVE


To assess the suitability of nanocrystalline-coated silver dressings versus standard wound dressings in patients with type 2 diabetes after coronary revascularization.
METHODS


The study involved 194 patients who were divided into two homogeneous groups. The control group (n = 97) received a standard sterile dressing. The intervention group (n = 97) received silver dressings. Glycosylated hemoglobin, fructosamine, and creatinine were assessed in all patients. The emergence of superficial wound infection within 30 days was the primary endpoint of the study, and deep wound infections were a secondary endpoint.
MAIN RESULTS


Superficial wound infections were documented in 26 patients: 11 patients in the study group and 15 in the control group. There were no statistically significant differences between the analyzed groups regarding the occurrence of the primary endpoint. No deep wound infections were found in either the study or control group.
CONCLUSIONS


The frequency of sternotomy wound infection in patients with type 2 diabetes is comparable between patients treated with traditional dressings and those receiving silver dressings; therefore, to maximize cost savings, providers should consider using standard wound dressings in this patient population.",2019,"No deep wound infections were found in either the study or control group.
","['patients with type 2 diabetes after coronary revascularization', 'Patients with Type 2 Diabetes after Surgical Coronary Revascularization', 'patients with type 2 diabetes', '194 patients who were divided into two homogeneous groups']","['standard sterile dressing', 'silver dressings', 'Nanocrystalline-Coated Silver Dressings', 'nanocrystalline-coated silver dressings']","['Glycosylated hemoglobin, fructosamine, and creatinine', 'Superficial wound infections', 'frequency of sternotomy wound infection', 'deep wound infections', 'superficial wound infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1319597', 'cui_str': 'Silver dressing'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0060765', 'cui_str': 'D-Isoglucosamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound (morphologic abnormality)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0332805', 'cui_str': 'Deep wound (morphologic abnormality)'}]",194.0,0.0204518,"No deep wound infections were found in either the study or control group.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Parys', 'Affiliation': 'In the Department of Cardiac Surgery, Heart and Lung Transplantation and Mechanical Support, at the Silesian Center for Heart Disease, in Zabrze, Poland, Monika Parys, BSN, RN, is Head Nurse; Tomasz Jaźwiec, MD, is a cardiac surgery resident; Anetta Kowalczuk-Wieteska, PhD, MD, is Senior Assistant; Iwona Majchrzyk, RN, is a nurse; Halina Gancarczyk, RN, is a nurse; Aleksandra Skoczeń, RN, is a nurse; Julita Kumor, RN, is a nurse; Monika Mijacz, RN, is a nurse; Krzysztof Kubacki, MD, is a physician; Michał Oskar Zembala, MD, is Chief; and Marian Zembala, MD, is Director. Acknowledgments: This study was supported by grants from the Medical University of Silesia in Katowice: KNW-1-167 / N / 3/0, KNW-1-166 / N / 4/0, and KNW-1-210 / N / 6 / K. The authors have disclosed no other financial relationships related to this article. Submitted March 24, 2019; accepted in revised form May 31, 2019.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Jaźwiec', 'Affiliation': ''}, {'ForeName': 'Anetta', 'Initials': 'A', 'LastName': 'Kowalczuk-Wieteska', 'Affiliation': ''}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Majchrzyk', 'Affiliation': ''}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Gancarczyk', 'Affiliation': ''}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Skoczeń', 'Affiliation': ''}, {'ForeName': 'Julita', 'Initials': 'J', 'LastName': 'Kumor', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Mijacz', 'Affiliation': ''}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kubacki', 'Affiliation': ''}, {'ForeName': 'Michał Oskar', 'Initials': 'MO', 'LastName': 'Zembala', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Zembala', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000582620.68148.cf']
548,32209625,"G-CSF (filgrastim) treatment for amyotrophic lateral sclerosis: protocol for a phase II randomised, double-blind, placebo-controlled, parallel group, multicentre clinical study (STEMALS-II trial).","INTRODUCTION


Amyotrophic lateral sclerosis (ALS) is a fatal progressive neurological disorder characterised by a selective degeneration of motor neurons (MNs). Stem cell transplantation is considered as a promising strategy in neurological disorders therapy and the possibility of inducing bone marrow cells (BMCs) to circulate in the peripheral blood is suggested to investigate stem cells migration in degenerated ALS nerve tissues where potentially repair MN damage. Granulocyte-colony stimulating factor (G-CSF) is a growth factor which stimulates haematopoietic progenitor cells, mobilises BMCs into injured brain and it is itself a neurotrophic factor for MN. G-CSF safety in humans has been demonstrated and many observations suggest that it may affect neural cells. Therefore, we decided to use G-CSF to mobilise BMCs into the peripheral circulation in patients with ALS, planning a clinical trial to evaluate the effect of G-CSF administration in ALS patients compared with placebo.
METHODS AND ANALYSIS


STEMALS-II is a phase II multicentre, randomised double-blind, placebo-controlled, parallel group clinical trial on G-CSF (filgrastim) and mannitol in ALS patients. Specifically, we investigate safety, tolerability and efficacy of four repeated courses of intravenous G-CSF and mannitol administered in 76 ALS patients in comparison with placebo (indistinguishable glucose solution 5%). We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 +  cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment.
ETHICS AND DISSEMINATION


The study protocol was approved by the Ethics Committee of Azienda Ospedaliera Universitaria 'Città della Salute e della Scienza', Torino, Italy. Results will be presented during scientific symposia or published in scientific journals.
TRIAL REGISTRATION NUMBER


Eudract 2014-002228-28.",2020,"We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 +  cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment.
","['76 ALS patients in comparison with placebo (indistinguishable glucose solution 5', 'ALS patients', 'amyotrophic lateral sclerosis']","['G-CSF (filgrastim', 'placebo', 'intravenous G-CSF and mannitol', 'G-CSF (filgrastim) and mannitol', 'Granulocyte-colony stimulating factor (G-CSF', 'Stem cell transplantation']","['ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life', 'G-CSF levels', 'safety, tolerability and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0034380'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",76.0,0.346543,"We determine increase of G-CSF levels in serum and cerebrospinal fluid as CD34 +  cells and leucocyte count after treatment; reduction in ALS Functional Rating Scale-Revised Score, forced vital capacity, Scale for Testing Muscle Strength Score and quality of life; the adverse events/reactions during the treatment; changes in neuroinflammation biomarkers before and after treatment.
","[{'ForeName': 'Paolina', 'Initials': 'P', 'LastName': 'Salamone', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Fuda', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Casale', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy federico.casale@unito.it.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marrali', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lunetta', 'Affiliation': 'NEuroMuscular Omnicentre (NEMO), Fondazione Serena Onlus, Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caponnetto', 'Affiliation': 'Neurological Clinic, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Mazzini', 'Affiliation': 'Department of Neurology, Maggiore della Carità Hospital, University of Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'La Bella', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Sicilia, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mandrioli', 'Affiliation': 'Department of Neuroscience, Azienda Ospedaliera Universitaria Modena, St. Agostino-Estense Hospital, Modena, Italy.'}, {'ForeName': 'Isabella Laura', 'Initials': 'IL', 'LastName': 'Simone', 'Affiliation': 'Neurology Unit, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Puglia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Moglia', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Oncohematology Division, IEO European Institute of Oncology, IRCCS, University of Milan, Milano, Lombardia, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Chio', 'Affiliation': ""'Rita Levi Montalcini' Department of Neuroscience, University of Turin, Torino, Piemonte, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034049']
549,31974142,PPARA  Polymorphism Influences the Cardiovascular Benefit of Fenofibrate in Type 2 Diabetes: Findings From ACCORD-Lipid.,"The cardiovascular benefits of fibrates have been shown to be heterogeneous and to depend on the presence of atherogenic dyslipidemia. We investigated whether genetic variability in the  PPARA  gene, coding for the pharmacological target of fibrates (PPAR-α), could be used to improve the selection of patients with type 2 diabetes who may derive cardiovascular benefit from addition of this treatment to statins. We identified a common variant at the  PPARA  locus (rs6008845, C/T) displaying a study-wide significant influence on the effect of fenofibrate on major cardiovascular events (MACE) among 3,065 self-reported white subjects treated with simvastatin and randomized to fenofibrate or placebo in the ACCORD-Lipid trial. T/T homozygotes (36% of participants) experienced a 51% MACE reduction in response to fenofibrate (hazard ratio 0.49; 95% CI 0.34-0.72), whereas no benefit was observed for other genotypes ( P   interaction  = 3.7 × 10 -4 ). The rs6008845-by-fenofibrate interaction on MACE was replicated in African Americans from ACCORD ( N  = 585,  P  = 0.02) and in external cohorts (ACCORD-BP, ORIGIN, and TRIUMPH, total  N  = 3059,  P  = 0.005). Remarkably, rs6008845 T/T homozygotes experienced a cardiovascular benefit from fibrate even in the absence of atherogenic dyslipidemia. Among these individuals, but not among carriers of other genotypes, fenofibrate treatment was associated with lower circulating levels of CCL11-a proinflammatory and atherogenic chemokine also known as eotaxin ( P  for rs6008845-by-fenofibrate interaction = 0.003). The GTEx data set revealed regulatory functions of rs6008845 on  PPARA  expression in many tissues. In summary, we have found a common  PPARA  regulatory variant that influences the cardiovascular effects of fenofibrate and that could be used to identify patients with type 2 diabetes who would derive benefit from fenofibrate treatment, in addition to those with atherogenic dyslipidemia.",2020,T/T homozygotes (36% of participants) experienced a 51% MACE reduction in response to fenofibrate (HR=0.49; 95%C.I. 0.34-0.72) whereas no benefit was observed for other genotypes (p for interaction=3.7x10 -4 ).,"['Type 2 Diabetes', '3,065 self-reported White subjects treated with', 'patients with type 2 diabetes']","['Fenofibrate', 'simvastatin', 'fenofibrate', 'fenofibrate or placebo']","['circulating levels of CCL11 - a pro-inflammatory and atherogenic chemokine', 'major cardiovascular events (MACE']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",,0.0503884,T/T homozygotes (36% of participants) experienced a 51% MACE reduction in response to fenofibrate (HR=0.49; 95%C.I. 0.34-0.72) whereas no benefit was observed for other genotypes (p for interaction=3.7x10 -4 ).,"[{'ForeName': 'Mario Luca', 'Initials': 'ML', 'LastName': 'Morieri', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Hetal S', 'Initials': 'HS', 'LastName': 'Shah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sjaarda', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Petra A', 'Initials': 'PA', 'LastName': 'Lenzini', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Alison A', 'Initials': 'AA', 'LastName': 'Motsinger-Reif', 'Affiliation': 'Biostatistics and Computational Biology Branch, National Institute of Environmental Health Sciences, Durham, NC.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lovato', 'Affiliation': 'Wake Forest School of Medicine, Winston Salem, NC.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Prudente', 'Affiliation': 'Research Unit of Metabolic and Cardiovascular Diseases, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Assunta', 'Initials': 'A', 'LastName': 'Pandolfi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio,"" Chieti, Italy.'}, {'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Pezzolesi', 'Affiliation': 'Division of Nephrology and Hypertension and Diabetes and Metabolism Center, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Cumming School of Medicine, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Paré', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Santica M', 'Initials': 'SM', 'LastName': 'Marcovina', 'Affiliation': 'Department of Medicine, University of Washington, and Northwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Rotroff', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Patorno', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Mercuri', 'Affiliation': 'Research Unit of Metabolic and Cardiovascular Diseases, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Trischitta', 'Affiliation': 'Research Unit of Metabolic and Cardiovascular Diseases, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kraft', 'Affiliation': 'Departments of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wagner', 'Affiliation': 'Center for Pharmacogenomics and Individualized Therapy, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cresci', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Irving Institute for Clinical and Translational Research, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Josyf C', 'Initials': 'JC', 'LastName': 'Mychaleckyj', 'Affiliation': 'Center for Public Health Genomics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA alessandro.doria@joslin.harvard.edu.'}]",Diabetes,['10.2337/db19-0973']
550,32207134,"Comparison of Safety and Efficiency of General, Spinal and Epidural Anesthesia Methods Used for the Endoscopic Surgical Treatment of Ureteral Stones: Which One is Better To Access The Ureter and Reach The Stone?","PURPOSE


The aim of this study is to evaluate the effects of anesthesia methods on the success of urethral access and stone access achievement in endoscopic treatment of urolithiasis.
MATERIALS AND METHODS


In this prospective randomized study, 105 patients who underwent primary ureterorenoscopy (URS) procedure for ureteral stones were evaluated. The patients were randomized into three groups by permuted block randomization according to the applied anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA): 31 patients. Ten patients, whose ureteral access was not successful, were dropped out. The success of the three anesthesia methods on the success of the ureter access and its effects on surgical outcomes were compared.
RESULTS


There was no statistically significant difference among the three groups in terms of the demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status. Dilatation and the access time to stone were statistically significantly longer in SA and EA group compared to the GA group. There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates. The Visual Analog Scale (VAS) scores in the 8th and 24th hours were statistically significantly higher in the GA group.
CONCLUSION


In patients who decided to undergo primary ureterorenoscopy procedure, it can be suggested to treat with GA to provide a better relaxation of the ureter if there are no contraindications.",2020,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","['Ureteral Stones', '105 patients who underwent primary URS procedure for ureteral stones were evaluated']","['anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA']","['Visual Analog Scale (VAS) scores', 'operation, lithotripsy time, stone-free rate (SFR), and complication rates', 'demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status', 'Dilatation and the access time to stone']","[{'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]",105.0,0.0339014,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","[{'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Oztekin', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY. dr_unal@hotmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Caniklioglu', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Atac', 'Affiliation': 'Kırıkkale University, Faculty of Medicine, Department of Urology, Kırıkkale, TURKEY.'}, {'ForeName': 'Cigdem Unal', 'Initials': 'CU', 'LastName': 'Kantekin', 'Affiliation': 'Yozgat Bozok University, Faculty of Medicine, Department of Anesthesiology, Yozgat, TURKEY.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Gurel', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Isikay', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}]",Urology journal,['10.22037/uj.v0i0.5638']
551,31498030,Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.,"PURPOSE


Outcome measures that comprehensively capture attributes of immuno-oncology agents, including prolonged treatment-free time and persistent treatment-related adverse events (TRAEs), are needed to complement conventional survival end points.
METHODS


We pooled data from the CheckMate 067 and 069 clinical trials of nivolumab and ipilimumab, as monotherapies or in combination, for patients with advanced melanoma. Treatment-free survival (TFS) was defined as the area between Kaplan-Meier curves for two conventional time-to-event end points, each defined from random assignment: time to immune checkpoint inhibitor (ICI) protocol therapy cessation and time to subsequent systemic therapy initiation or death. TFS was partitioned as time with and without toxicity by a third end point, time to cessation of both ICI therapy and toxicity. Toxicity included persistent and late-onset grade 3 or higher TRAEs. The area under each Kaplan-Meier curve was estimated by the 36-month restricted mean time.
RESULTS


At 36 months, many of the 1,077 patients who initiated ICI therapy were surviving free of subsequent therapy initiation (47% nivolumab plus ipilimumab, 37% nivolumab, 15% ipilimumab). The restricted mean TFS was longer for nivolumab plus ipilimumab (11.1 months) compared with nivolumab (4.6 months; difference, 6.5 months; 95% CI, 5.0 to 8.0 months) or ipilimumab (8.7 months; difference, 2.4 months; 95% CI, 0.8 to 4.1 months); restricted mean TFS represented 31% (3% with and 28% without toxicity), 13% (1% and 11%), and 24% (less than 1% and 23%) of the 36-month period, respectively, in the three treatment groups. TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
CONCLUSION


The analysis of TFS between ICI cessation and subsequent therapy initiation revealed longer TFS without toxicity for patients with advanced melanoma who received nivolumab plus ipilimumab compared with nivolumab or ipilimumab. Regardless of treatment, a small proportion of the TFS involved grade 3 or higher TRAEs.",2019,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","['Patients With Advanced Melanoma', 'patients with advanced melanoma']","['nivolumab plus ipilimumab', 'Immune Checkpoint Inhibition', 'ipilimumab', 'nivolumab or ipilimumab', 'nivolumab and ipilimumab', 'TFS']","['Treatment-free survival (TFS', 'TFS without toxicity', 'surviving free of subsequent therapy initiation', 'mean TFS', 'Treatment-Free Survival', 'Toxicity included persistent and late-onset grade 3 or higher TRAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1077.0,0.196501,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","[{'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sumati', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gupte-Singh', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh, PA.'}, {'ForeName': 'Harriet M', 'Initials': 'HM', 'LastName': 'Kluger', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Postow', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Ritchings', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'Emory University and Winship Comprehensive Cancer Center, Atlanta, GA.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Harvard Medical School, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00345']
552,32209630,Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial.,"INTRODUCTION


Current pharmacological treatment options for hyperemesis gravidarum have been introduced based on scarce evidence and are often not sufficiently effective. Several case reports suggest that mirtazapine, an antidepressant, may be an effective treatment for hyperemesis gravidarum, but so far there are no controlled trials investigating the potential effect of mirtazapine on hyperemesis gravidarum. The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women. This study aims to investigate the effect of mirtazapine on hyperemesis gravidarum while also providing data on the effect of ondansetron.
METHODS AND ANALYSIS


This randomised double-blind placebo-controlled multicentre trial will be conducted in eight Danish hospitals. One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum will be randomly allocated to 14-day treatment with either mirtazapine, ondansetron or placebo. Main inclusion criterion will be Pregnancy Unique Quantification of Emesis (PUQE-24) score ≥13 or PUQE-24 score ≥7 if accompanied by weight loss >5% of pre-pregnancy weight or hospitalisation. Participants are eligible regardless of whether other antiemetics, including ondansetron, have been tried. The coprimary outcomes are effects of mirtazapine and ondansetron, respectively, on PUQE-24 score tested hierarchically on day 2 and day 14. Secondary outcomes include, but are not limited to, differences between the three groups in number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects.
ETHICS AND DISSEMINATION


The trial has been approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. Results will be published in peer-reviewed journals and submitted to relevant conferences.
TRIAL REGISTRATION NUMBER


NCT03785691.",2020,The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women.,"['eight Danish hospitals', 'One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum', 'pregnant women']","['mirtazapine', 'mirtazapine, ondansetron or placebo', 'placebo', 'Ondansetron and Mirtazapine', 'mirtazapine and ondansetron', 'ondansetron', 'antiemetic ondansetron']","['number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0020450', 'cui_str': 'Pernicious Vomiting of Pregnancy'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0162643'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",180.0,0.690313,The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ostenfeld', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Tonny Studsgaard', 'Initials': 'TS', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tina Bergmann', 'Initials': 'TB', 'LastName': 'Futtrup', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Jon Trærup', 'Initials': 'JT', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Andreas Kryger', 'Initials': 'AK', 'LastName': 'Jensen', 'Affiliation': 'Department of Research, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Hanne Brix', 'Initials': 'HB', 'LastName': 'Westergaard', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Lars Henning', 'Initials': 'LH', 'LastName': 'Pedersen', 'Affiliation': 'Department Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ellen Christine Leth', 'Initials': 'ECL', 'LastName': 'Løkkegaard', 'Affiliation': 'Department of Gynecology and Obstetrics, Nordsjaellands Hospital, Hillerod, Denmark Ellen.Christine.Leth.Loekkegaard@regionh.dk.'}]",BMJ open,['10.1136/bmjopen-2019-034712']
553,31553945,Parent Perceptions on a Walking School Bus Program Among Low-Income Families: A Qualitative Study.,"BACKGROUND


The walking school bus (WSB) is a promising intervention to increase walking to school and physical activity in school-age children. The aim of this qualitative study was to assess parent perceptions of a WSB program that was part of a randomized controlled trial to inform future programs.
METHODS


The authors interviewed 45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route. The authors performed a qualitative analysis of the interview transcripts and coded interview segments into 4 broad categories as follows: facilitators, barriers, general positive sentiments, and proposals.
RESULTS


Most parents spoke of the benefits of the WSB program; in particular, parents frequently applauded exercise/physical health benefits. Of the barriers, the most frequently cited was time, with work schedule and commute changes leading some families to walk less frequently.
CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models. Parents made several suggestions to improve the program, including better recruitment methods, logistical improvements, and a platform for communicating with other parents.",2019,"CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","['school-age children', '45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route', 'Low-Income Families']",['walking school bus (WSB'],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0336816', 'cui_str': 'School bus, device (physical object)'}]",[],45.0,0.0365653,"CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Teller', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abbey-Lambertz', 'Affiliation': ''}, {'ForeName': 'Nasira', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Waite', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Ickes', 'Affiliation': ''}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0637']
554,32206903,"Efficacy and safety of generic exenatide injection in Chinese patients with type 2 diabetes: a multicenter, randomized, controlled, non-inferiority trial.","AIMS


This study aimed to compare the efficacy and safety of generic exenatide with branded exenatide Byetta ®  in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on monotherapy or combination therapy of metformin and insulin secretagogues.
METHODS


A multicenter, randomized, controlled, non-inferiority trial was performed. A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment. The primary endpoint was the change in HbA1c levels from baseline at week 16, with a non-inferiority margin of - 0.35% (- 3.83 mmol/mol) (lower bound of one-sided 95% confidence interval (CI) > - 0.35% (- 3.83 mmol/mol)). Secondary endpoints included the proportion of participants achieving HbA1c < 7% (53 mmol/mol), the changes in fasting plasma glucose (FPG), 2-h postprandial glucose (2hPG) following a standard meal, 7-point self-monitoring blood glucose (SMBG) profiles, body weight change from baseline at week 16 and the change in HbA1c levels from baseline at week 8. Safety issues were also evaluated.
RESULTS


After 16 weeks of treatment, HbA1c levels decreased significantly from baseline in the two groups, with a reduction of - 1.10% ± 1.31% (- 12.0 mmol/mol ± 14.3 mmol/mol) in the generic exenatide group and - 1.08% ± 1.11% (- 11.8 mmol/mol ± 12.1 mmol/mol) in the branded exenatide group (both P < 0.001). The least-squares mean difference of HbA1c reduction between the two groups was - 0.03% (- 0.33 mmol/mol), with a lower one-sided 95% CI limit of - 0.27% (- 2.95 mmol/mol), which was higher than the prespecified non-inferiority margin of - 0.35% (- 3.83 mmol/mol). Moreover, there were no significant differences in the proportion of participants achieving HbA1c < 7% (53 mmol/mol) and the changes in FPG, 2hPG, 7-point SMBG profiles and body weight at week 16 and the change in HbA1c levels from baseline at week 8 (all P > 0.05) between the two groups. The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
CONCLUSIONS


In patients with T2DM inadequately controlled on monotherapy or combination therapy of metformin and insulin secretagogues, add-on treatment with generic exenatide demonstrated non-inferiority to branded exenatide in terms of improvements in HbA1c after 16 weeks of treatment. Furthermore, the two drugs were also similar for other efficacy endpoints and safety profile. Trial registration Chinese Clinical Trial Registry: ChiCTR-IPR-15006558, Date registered May 27, 2015.",2020,"The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
","['Chinese patients with type 2 diabetes mellitus (T2DM', '240 patients with T2DM and glycated hemoglobin (HbA1c)\u2009≥\u20097% (53\xa0mmol/mol) to\u2009≤\u20099.0% (75\xa0mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3\xa0months', 'Chinese patients with type 2 diabetes']","['metformin', 'generic exenatide with branded exenatide Byetta ®', 'generic exenatide injection', 'generic exenatide or branded exenatide']","['incidence of hypoglycemia', 'Efficacy and safety', 'efficacy endpoints and safety profile', 'efficacy and safety', 'proportion of participants achieving HbA1c\u2009<\u20097% (53\xa0mmol/mol), the changes in fasting plasma glucose (FPG), 2-h postprandial glucose (2hPG) following a standard meal, 7-point self-monitoring blood glucose (SMBG) profiles, body weight change', 'changes in FPG, 2hPG, 7-point SMBG profiles and body weight', 'HbA1c levels', 'HbA1c reduction', 'change in HbA1c levels', 'incidence of adverse events']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4704833', 'cui_str': 'Secretagogues'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1636686', 'cui_str': 'Byetta'}, {'cui': 'C4026823', 'cui_str': 'exenatide Injection [Bydureon]'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0444664', 'cui_str': 'Standard meal (finding)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",240.0,0.123472,"The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Endocrinology, Beijing Hospital, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, PLA Rocket Force Characteristic Medical Center, Beijing, 100088, People's Republic of China.""}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Endocrinology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.""}, {'ForeName': 'Jinkui', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, The First Hospital of Shanxi Medical University, Taiyuan, 030001, People's Republic of China.""}, {'ForeName': 'Yongyi', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, People's Hospital of Hainan Province, Haikou, 570311, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Tianpei', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China. tpho66@bjmu.edu.cn.""}]",Acta diabetologica,['10.1007/s00592-020-01510-y']
555,32404782,"Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial.","BACKGROUND


Vaccination against seasonal influenza is recommended for all children with a history of medical conditions placing them at increased risk of influenza-associated complications. The immunogenicity and efficacy of conventional influenza vaccines among young children are suboptimal; one strategy to enhance these is adjuvantation. We present immunogenicity and safety data for an MF59-adjuvanted quadrivalent influenza vaccine (aIIV4) in healthy children and those at a high risk of influenza-associated complications, based on the results of a recently completed phase III study.
METHODS


Children 6 months to 5 years of age (N = 10,644) were enrolled. The study was conducted across northern hemisphere seasons 2013-2014 and 2014-2015. Subjects received either aIIV4 or a nonadjuvanted comparator influenza vaccine. Antibody responses were assessed by hemagglutination inhibition assay against vaccine and heterologous strains. Long-term antibody persistence was assessed (ClinicalTrials.gov: NCT01964989).
RESULTS


aIIV4 induced significantly higher antibody titers than nonadjuvanted vaccine in high-risk subjects. aIIV4 antibody responses were of similar magnitude in high-risk and healthy subjects. Incidence of solicited local and systemic adverse events (AEs) was slightly higher in aIIV4 than nonadjuvanted vaccinees, in both the healthy and high-risk groups. Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups.
CONCLUSION


aIIV4 was more immunogenic than nonadjuvanted vaccine in both the healthy and high-risk study groups. The reactogenicity and safety profiles of aIIV4 and the nonadjuvanted vaccine were acceptable and similar in 6-month- to 5-year-old high-risk and healthy children.",2020,"Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups.
","['young children', 'Children 6 months to 5 years of age (N = 10,644) were enrolled', 'healthy children and those at a high risk of influenza-associated complications', 'northern hemisphere seasons 2013-2014 and 2014-2015', 'Young Children at High Risk of Influenza-associated Complications']","['MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine', 'MF59-adjuvanted quadrivalent influenza vaccine (aIIV4', 'conventional influenza vaccines', 'nonadjuvanted vaccine', 'aIIV4 or a nonadjuvanted comparator influenza vaccine']","['Antibody responses', 'immunogenicity and efficacy', 'antibody titers', 'Incidence of unsolicited AEs, serious AEs and AEs of special interest', 'Immunogenicity and Safety', 'Incidence of solicited local and systemic adverse events (AEs']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",10644.0,0.0497908,"Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'From the Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fling', 'Affiliation': 'Department of Pediatrics, Health Science Center, University of North Texas, Fort Worth, TX.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Bruijn', 'Affiliation': 'Seqirus Netherlands B.V., Amsterdam, The Netherlands.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Oberye', 'Affiliation': 'Seqirus Netherlands B.V., Amsterdam, The Netherlands.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Seqirus USA Inc., Cambridge, MA.'}, {'ForeName': 'Jeanique', 'Initials': 'J', 'LastName': 'Vossen', 'Affiliation': 'Seqirus Netherlands B.V., Amsterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Heijnen', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Seqirus USA Inc., Cambridge, MA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002727']
556,30939090,Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.,"PURPOSE


Alliance/CALGB 50303 (NCT00118209), an intergroup, phase III study, compared dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as frontline therapy for diffuse large B-cell lymphoma.
PATIENTS AND METHODS


Patients received six cycles of DA-EPOCH-R or R-CHOP. The primary objective was progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety.
RESULTS


Between 2005 and 2013, 524 patients were registered; 491 eligible patients were included in the final analysis. Most patients (74%) had stage III or IV disease; International Prognostic Index (IPI) risk groups included 26% IPI 0 to 1, 37% IPI 2, 25% IPI 3, and 12% IPI 4 to 5. At a median follow-up of 5 years, PFS was not statistically different between the arms (hazard ratio, 0.93; 95% CI, 0.68 to 1.27;  P  = .65), with a 2-year PFS rate of 78.9% (95% CI, 73.8% to 84.2%) for DA-EPOCH-R and 75.5% (95% CI, 70.2% to 81.1%) for R-CHOP. OS was not different (hazard ratio, 1.09; 95% CI, 0.75 to 1.59;  P  = .64), with a 2-year OS rate of 86.5% (95% CI, 82.3% to 91%) for DA-EPOCH-R and 85.7% (95% CI, 81.4% to 90.2%) for R-CHOP. Grade 3 and 4 adverse events were more common ( P  < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9%  v  10.7%, respectively), febrile neutropenia (35.0%  v  17.7%, respectively), mucositis (8.4%  v  2.1%, respectively), and neuropathy (18.6%  v  3.3%, respectively). Five treatment-related deaths (2.1%) occurred in each arm.
CONCLUSION


In the 50303 study population, the more intensive, infusional DA-EPOCH-R was more toxic and did not improve PFS or OS compared with R-CHOP. The more favorable results with R-CHOP compared with historical controls suggest a potential patient selection bias and may preclude generalizability of results to specific risk subgroups.",2019,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","['524 patients were registered; 491 eligible patients were included in the final analysis', 'Between 2005 and 2013', 'diffuse large B-cell lymphoma', 'Patients received six cycles of', 'Diffuse Large B-Cell Lymphoma']","['Dose-Adjusted EPOCH-R Compared With R-CHOP', 'etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'DA-EPOCH-R or R-CHOP']","['febrile neutropenia', 'PFS or OS', 'mucositis', 'stage III or IV disease; International Prognostic Index', 'progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety', 'Grade 3 and 4 adverse events', 'infection', '2-year PFS rate', 'neuropathy', '2-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4520227', 'cui_str': 'Dose-adjusted EPOCH'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",524.0,0.170783,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': '4 Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '6 MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': '7 University of Rochester, Rochester, NY.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nina D', 'Initials': 'ND', 'LastName': 'Wagner-Johnston', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': '8 The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Abramson', 'Affiliation': '9 Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Nishitha M', 'Initials': 'NM', 'LastName': 'Reddy', 'Affiliation': '10 Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': '11 Northwestern University, Chicago, IL.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': '12 University of Wisconsin, Madison, WI.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': '13 Univeristy of Washington, Seattle, WA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': '15 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': '16 University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01994']
557,30470978,The Effects of the Nurse Navigation Program in Promoting Colorectal Cancer Screening Behaviors: a Randomized Controlled Trial.,"Although screening programs are known and recommended for the early detection of colorectal cancer (CRC), the screening rates for the fecal occult blood test (FOBT) and colonoscopy are very low among adult individuals. Navigation programs, also known as individualized counseling, have recently begun to be used for increasing screening rates. The purpose of this study was to compare the efficacy of the Nurse Navigation Program versus usual care on CRC screening participation and movement in stage of adoption for CRC screening and to examine perceived benefits of and barriers to CRC screening. This study was designed in line with a pre- and posttest two-group methodology. A total of 110 participants (55 nurse-navigated and 55 non-navigated patients) were studied. Data were collected using the following three tools: a sociodemographic information form, the Harvard Colorectal Cancer Risk Assessment Tool, and Instruments to Measure Colorectal Cancer Screening Benefits and Barriers. Following the Nurse Navigation Program, the FOBT (82 and 84%, respectively) and colonoscopy completion rates (15 and 22%, respectively) were significantly higher in the nurse-navigated group than in the non-navigated group at 3 and 6 months follow-up. Following the program, the benefit perceptions of the nurse-navigated group about CRC screening were improved, and their barrier perceptions were reduced. The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening. Further assessment of the Nurse Navigation Program in different groups should be performed to observe its effects.",2020,The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening.,"['Colorectal Cancer Screening Behaviors', '110 participants (55 nurse-navigated and 55 non-navigated patients']","['Nurse Navigation Program versus usual care', 'Nurse Navigation Program']","['colonoscopy completion rates', 'CRC screening behavior and health-related beliefs concerning CRC screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",110.0,0.0176525,The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening.,"[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Temucin', 'Affiliation': 'Nursing Faculty, Oncology Nursing Department, University of Health Sciences, Istanbul, Turkey. temucinelif@gmail.com.'}, {'ForeName': 'Nursen O', 'Initials': 'NO', 'LastName': 'Nahcivan', 'Affiliation': 'Florence Nightingale Nursing Faculty, Public Health Nursing Department, Istanbul University, Istanbul, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1448-z']
558,32404342,"Canakinumab for Treatment of Adult-Onset Still's Disease to Achieve Reduction of Arthritic Manifestation (CONSIDER): phase II, randomised, double-blind, placebo-controlled, multicentre, investigator-initiated trial.","BACKGROUND


Inhibition of interleukin (IL)-1 represents a promising treatment option in adult-onset Still's disease (AOSD).
OBJECTIVE


To investigate the efficacy and safety of canakinumab in patients with AOSD and active joint involvement by means of a multicentre, double-blind, randomised, placebo-controlled trial.
METHODS


Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4 each) were treated with canakinumab (4 mg/kg, maximum 300 mg subcutaneous every 4 weeks) or placebo. The primary endpoint was the proportion of patients with a clinically relevant reduction in disease activity at week 12 as determined by the change in disease activity score (ΔDAS28>1.2).
RESULTS


At enrolment, patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the placebo group, respectively. In the intention-to-treat analysis, 12 patients (67%) in the canakinumab group and 7 patients (41%) in the placebo group fulfilled the primary outcome criterion (p=0.18). In the per-protocol analysis, significantly higher American College of Rheumatology (ACR) 30% (61% vs 20%, p=0.033), ACR 50% (50% vs 6.7%, p=0.009) and ACR 70% (28% vs 0%, p=0.049) response rates were observed in the canakinumab group compared with the placebo group. Two patients in the canakinumab group experienced a serious adverse event.
CONCLUSION


Although the study was terminated prematurely and the primary endpoint was not achieved, treatment with canakinumab led to an improvement of several outcome measures in AOSD. The overall safety findings were consistent with the known profile of canakinumab. Thus, our data support indication for IL-1 inhibition with canakinumab in AOSD.",2020,"Two patients in the canakinumab group experienced a serious adverse event.
","[""adult-onset Still's disease (AOSD"", 'patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the', 'patients with AOSD and active joint involvement by means of a multicentre', 'Adult-Onset', 'Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4\u2009each']","['canakinumab', 'interleukin (IL)-1', 'Canakinumab', 'canakinumab (4\u2009mg/kg, maximum 300\u2009mg subcutaneous every 4 weeks) or placebo', 'placebo']","['several outcome measures in AOSD', 'response rates', 'American College of Rheumatology (ACR', 'disease activity score (ΔDAS28>1.2', 'serious adverse event', 'proportion of patients with a clinically relevant reduction in disease activity', 'efficacy and safety']","[{'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.675758,"Two patients in the canakinumab group experienced a serious adverse event.
","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kedor', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany claudia.kedor@charite.de.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Listing', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Zernicke', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Weiß', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'CIRI/Rheumatology and Fraunhofer TMP, Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Blank', 'Affiliation': 'Internal Medicine 5, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Joerg Christoph', 'Initials': 'JC', 'LastName': 'Henes', 'Affiliation': 'Centre for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases and Department of Internal Medicine II (Oncology, Haematology, Immunology, Rheumatology, Pulmology), University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Kekow', 'Affiliation': 'Clinic of Rheumatology and Orthopaedics, Otto-von-Guericke University Magdeburg, Vogelsang-Gommern, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubbert-Roth', 'Affiliation': 'Division of Rheumatology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Department of Rheumatology, University of Munich, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Seipelt', 'Affiliation': 'Abteilung Rheumatologie und Klinische Immunologie, Immanuel Krankenhaus Berlin, Standort Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Specker', 'Affiliation': 'Klinik für Rheumatologie und Klinische Immunologie, KEM Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Feist', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217155']
559,32199866,Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials.,"PURPOSE


To assess visual function outcomes to 48 weeks in patients with bilateral geographic atrophy (GA) secondary to age-related macular degeneration included in 2 interventional clinical trials: relationship to baseline lesion size, outcomes by baseline lesion characteristic subgroups, and correlation of visual function outcomes with GA area.
DESIGN


The Chroma and Spectri studies (ClinicalTrials.gov identifiers, NCT02247479 and NCT02247531, respectively) were identically designed phase 3, double-masked, multicenter, randomized, sham injection-controlled clinical trials that evaluated intravitreal lampalizumab in GA.
PARTICIPANTS


Eligible patients were 50 years of age or older with well-demarcated bilateral GA (lesion size, 1-7 disc areas) without evidence of or previous treatment for choroidal neovascularization in either eye and best-corrected visual acuity (BCVA) letter score of 49 letters or more (≥1 GA lesion within 250 μm of foveal center if BCVA ≥79 letters).
METHODS


Patients (pooled n = 1881) were randomized 2:1:2:1 to lampalizumab every 4 weeks, sham every 4 weeks, lampalizumab every 6 weeks, or sham every 6 weeks. Sham arms were pooled for analysis.
MAIN OUTCOME MEASURES


Functional end points included change in BCVA from baseline to week 48, low-luminance visual acuity, mesopic microperimetry (number of absolute scotomatous points, mean macular sensitivity), binocular and monocular maximum reading speed, and 2 validated patient-reported outcome measures: Functional Reading Independence Index and 25-item National Eye Institute Visual Function Questionnaire.
RESULTS


Enlargement of GA area, approximately 2 mm 2 /year on average across all treatment groups in each study, was accompanied by overall deterioration in all functional end points. No statistically significant differences were found between lampalizumab or sham arms for changes from baseline in functional assessment scores. Of visual function tests, only microperimetry outcomes were correlated moderately with GA lesion area when assessed cross-sectionally at baseline and week 48.
CONCLUSIONS


Chroma and Spectri provide a unique data set of functional end points in GA that are relevant for future clinical trials. Patients with bilateral GA experienced a consistent decline in visual function over 48 weeks, but measures of visual function were not correlated strongly with GA lesion area. It is not possible to predict visual function outcomes from GA lesion size.",2020,No statistically significant differences were found between lampalizumab or sham arms for changes from baseline in functional assessment scores.,"['Eligible patients were 50 years of age or older with well-demarcated bilateral GA (lesion size, 1-7 disc areas) without evidence of or previous treatment for choroidal neovascularization in either eye and best-corrected visual acuity (BCVA) letter score of 49 letters or more (≥1 GA lesion within 250 μm of foveal center if BCVA ≥79 letters', 'patients with bilateral geographic atrophy (GA) secondary to age-related macular degeneration included in 2 interventional clinical trials', 'Patients (pooled n\xa0= 1881', 'Geographic Atrophy']",['lampalizumab'],"['visual function outcomes', 'visual function', 'functional assessment scores', 'Visual Function Decline', 'low-luminance visual acuity, mesopic microperimetry (number of absolute scotomatous points, mean macular sensitivity), binocular and monocular maximum reading speed, and 2 validated patient-reported outcome measures: Functional Reading Independence Index and 25-item National Eye Institute Visual Function Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}]","[{'cui': 'C4054668', 'cui_str': 'lampalizumab'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0234684', 'cui_str': 'Luminance, function (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1881.0,0.636261,No statistically significant differences were found between lampalizumab or sham arms for changes from baseline in functional assessment scores.,"[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Pieramici', 'Affiliation': 'California Retina Consultants, Santa Barbara, California.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Centre for Public Health, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'Ophthalmology Specialists of Texas, PLLC, and Integrated Clinical Research, LLC, Abilene, Texas.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Retina Specialty Institute, Pensacola, Florida.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lotery', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Eleonora M', 'Initials': 'EM', 'LastName': 'Lad', 'Affiliation': 'Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Silverman', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Henry', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Anderesi', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tschosik', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ferrara', 'Affiliation': 'Genentech, Inc., South San Francisco, California. Electronic address: ferrara.daniela@gene.com.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Department of Surgery, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.01.019']
560,32197732,Psychometric Analysis of the Abdominal Score From the Diary for Irritable Bowel Syndrome Symptoms-Constipation Using Phase IIb Clinical Trial Data.,"OBJECTIVES


The Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) has been developed to assess the core signs and symptoms of irritable bowel syndrome with constipation (IBS-C). This article presents the psychometric evaluation of the DIBSS-C abdominal score.
METHODS


Data for these analyses are from a multicenter phase IIb study in IBS-C patients (NCT02559206). Subjects completed a number of assessments via handheld electronic diary throughout the study. The analyses used the intent-to-treat population and were blinded to randomized treatment group. The analyses evaluated the reliability, validity, and responsiveness of the DIBSS-C abdominal score; identified an appropriate scoring algorithm; and determined thresholds for interpreting clinically meaningful changes at the individual level.
RESULTS


The correlations between the DIBSS-C abdominal symptom items (ie, abdominal pain, discomfort, and bloating) were strong (>0.75). Cronbach's alpha for the abdominal symptom severity items was very strong (.94), indicating that the 3 abdominal symptom items produce a reliable score. The intraclass correlation coefficient for the abdominal score was 0.82, exceeding the threshold of 0.70 and indicating good test-retest reliability. Guyatt's responsiveness statistic values all exceeded the threshold for a large effect of 0.80, so the DIBSS-C abdominal score can be considered highly responsive to change. Triangulation across 3 sets of anchor-based analyses indicated that a threshold of -2.0 points on the abdominal score is an appropriate threshold for identifying meaningful change.
CONCLUSIONS


Overall, this study provides evidence that the DIBSS-C abdominal score is valid, reliable, responsive to change, and interpretable for assessing treatment benefit in patients with IBS-C.",2020,"Cronbach's alpha for the abdominal symptom severity items was very strong (.94), indicating that the 3 abdominal symptom items produce a reliable score.","['patients with IBS-C', 'Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C']",[],"['DIBSS-C abdominal symptom items (ie, abdominal pain, discomfort, and bloating', 'abdominal score', 'Irritable Bowel Syndrome Symptoms-Constipation', 'reliability, validity, and responsiveness of the DIBSS-C abdominal score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",[],"[{'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",,0.0463545,"Cronbach's alpha for the abdominal symptom severity items was very strong (.94), indicating that the 3 abdominal symptom items produce a reliable score.","[{'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Coon', 'Affiliation': 'Outcometrix, St Petersburg, FL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hanlon', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, MA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Abel', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'J Jason', 'Initials': 'JJ', 'LastName': 'Lundy', 'Affiliation': 'Outcometrix, St Petersburg, FL, USA. Electronic address: jlundy@outcometrix.com.'}, {'ForeName': 'Robyn T', 'Initials': 'RT', 'LastName': 'Carson', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Reasner', 'Affiliation': 'Imbria Pharmaceuticals, Boston, MA, USA.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.01.002']
561,32100943,Microbial contamination and plaque scores of nanogold-coated toothbrush.,"OBJECTIVE


The study aimed to evaluate the microbial contamination and plaque scores of nanogold-coated and uncoated toothbrushes.
METHODS


This study was designed as a single-centre, parallel, examiner-blinded, randomized, two-group clinical trial. Eighty-four participants were enrolled and randomly assigned to receive either a nanogold or uncoated toothbrush. Basic periodontal therapy was performed for all the recruited subjects, and plaque scores of zero were considered baseline values. All participants were instructed to follow a twice-daily brushing regimen without dentifrice and to refrain from other oral hygiene care during the one-week study period. Plaque levels were assessed after one week using the Turesky modification of the Quigley-Hein Plaque Index (TMQHPI). The bristles were tested for microbial contamination by viable cell counting. The recorded data were statistically analysed, and a P-value of <.05 was accepted as statistically significant.
RESULTS


After one week of brushing without using toothpaste, the mean plaque index scores were 0.37 ± 0.07 in the nanogold group and 0.58 ± 0.10 in the uncoated group. A significant difference in the mean plaque scores was observed between the groups (P < .001). The mean colony-forming unit (CFU) was 21 ± 48.8 for the nanogold-coated group and 100 ± 128.4 for the uncoated group. The difference in the mean CFUs observed between the groups was significant (P = .014).
CONCLUSION


The use of a nanogold-coated toothbrush demonstrated significantly lower bristle contamination and lower plaque scores after one week compared with uncoated toothbrushes without using dentifrice.",2020,The use of a nano-gold coated toothbrush demonstrated significantly lower bristle contamination and lower plaque scores after one week compared with uncoated toothbrushes without using dentifrice.,['Eighty-four participants'],['nano-gold or uncoated toothbrush'],"['mean plaque index scores', 'Microbial contamination and plaque scores', 'microbial contamination and plaque scores', 'mean colony-forming unit (CFU', 'Plaque levels', 'mean plaque scores', 'mean CFUs', 'bristle contamination and lower plaque scores']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}]","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush, device (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",84.0,0.0277366,The use of a nano-gold coated toothbrush demonstrated significantly lower bristle contamination and lower plaque scores after one week compared with uncoated toothbrushes without using dentifrice.,"[{'ForeName': 'Pavithra', 'Initials': 'P', 'LastName': 'Durgesh', 'Affiliation': 'Department of Periodontology and Oral implantology, Bangalore Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Srirangarajan', 'Initials': 'S', 'LastName': 'Sridharan', 'Affiliation': 'Department of Periodontology and Oral implantology, Bangalore Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Srikumar K', 'Initials': 'SK', 'LastName': 'Prabhu', 'Affiliation': 'Department of Periodontology and Oral implantology, Bangalore Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Department of Periodontology and Oral implantology, Bangalore Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Vinaya', 'Initials': 'V', 'LastName': 'Rudresh', 'Affiliation': 'Department of Periodontology and Oral implantology, Bangalore Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Durgesh', 'Initials': 'D', 'LastName': 'H Bangalore', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}]",International journal of dental hygiene,['10.1111/idh.12433']
562,31884078,Text message link to online survey: A new highly effective method of longitudinal data collection.,"OBJECTIVES


To evaluate response rate to a text message link for an online survey as a method of data collection over the course of a medication abortion.
STUDY DESIGN


This is a secondary analysis of a randomized, double-blind, placebo-controlled trial of 110 women initiating a medication abortion up to 70 days gestation. We sent a text message containing a link to an online survey collecting pain scores, analgesic use, and adverse effects at six time points over 72 h from time of misoprostol administration (0-, 2-, 6-, 12-, 24-, and 72-hours). Our primary outcome was the proportion of all text messages sent for which an online survey response was received. Secondary outcomes included the proportion of complete responses (all six surveys), responses received more than two hours after text prompt (defined as late), and differences in response rate by time of day.
RESULTS


From June 2015 to October 2016, we screened 241 women, and 110 were randomized. We excluded three (1.2%) due to lack of a cellular phone with text capability, and three (2.7%) were lost to follow-up after enrollment. We received a response to 95.9% (633/660) of the delivered surveys, and 93.6% (103/110) of participants completed all six surveys. Over three-quarters of all responses were received within two hours of the requested time. Surveys sent before 08:00 were more likely to be returned late.
CONCLUSIONS


In this population of women seeking medication abortion, text message link to online survey response appears to be an effective mode of data collection.
IMPLICATIONS


Text message prompts for an online survey may optimize longitudinal real-time data collection response rates of sensitive data.",2020,"We received a response to 95.9% (633/660) of the delivered surveys, and 93.6% (103/110) of participants completed all six surveys.","['From June 2015 to October 2016, we screened 241 women, and 110 were randomized', '110 women initiating a medication abortion up to 70 days gestation']",['placebo'],"['response rate by time of day', 'proportion of complete responses (all six surveys), responses received more than two hours after text prompt (defined as late', 'proportion of all text messages sent for which an online survey response']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439548', 'cui_str': 'Temporal periods of day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",110.0,0.454717,"We received a response to 95.9% (633/660) of the delivered surveys, and 93.6% (103/110) of participants completed all six surveys.","[{'ForeName': 'EmmaKate B', 'Initials': 'EB', 'LastName': 'Friedlander', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI. Electronic address: Emmakate@hawaii.edu.'}, {'ForeName': 'Reni', 'Initials': 'R', 'LastName': 'Soon', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Salcedo', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tschann', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI.'}, {'ForeName': 'Tiana', 'Initials': 'T', 'LastName': 'Fontanilla', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI.'}, {'ForeName': 'Bliss', 'Initials': 'B', 'LastName': 'Kaneshiro', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI.'}]",Contraception,['10.1016/j.contraception.2019.11.008']
563,31180194,"An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes.","BACKGROUND


Type 1 diabetes is a chronic autoimmune disease that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival. Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed.
METHODS


We conducted a phase 2, randomized, placebo-controlled, double-blind trial of teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody) involving relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease. Patients were randomly assigned to a single 14-day course of teplizumab or placebo, and follow-up for progression to clinical type 1 diabetes was performed with the use of oral glucose-tolerance tests at 6-month intervals.
RESULTS


A total of 76 participants (55 [72%] of whom were ≤18 years of age) underwent randomization - 44 to the teplizumab group and 32 to the placebo group. The median time to the diagnosis of type 1 diabetes was 48.4 months in the teplizumab group and 24.4 months in the placebo group; the disease was diagnosed in 19 (43%) of the participants who received teplizumab and in 23 (72%) of those who received placebo. The hazard ratio for the diagnosis of type 1 diabetes (teplizumab vs. placebo) was 0.41 (95% confidence interval, 0.22 to 0.78; P = 0.006 by adjusted Cox proportional-hazards model). The annualized rates of diagnosis of diabetes were 14.9% per year in the teplizumab group and 35.9% per year in the placebo group. There were expected adverse events of rash and transient lymphopenia. KLRG1+TIGIT+CD8+ T cells were more common in the teplizumab group than in the placebo group. Among the participants who were HLA-DR3-negative, HLA-DR4-positive, or anti-zinc transporter 8 antibody-negative, fewer participants in the teplizumab group than in the placebo group had diabetes diagnosed.
CONCLUSIONS


Teplizumab delayed progression to clinical type 1 diabetes in high-risk participants. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01030861.).",2019,TIGIT+KLRG1+CD8+ T cells were more common in the teplizumab group than in the placebo group.,"['patients with type 1 diabetes', 'participants who were HLA-DR3-negative, HLA-DR4-positive, or anti-zinc transporter 8 antibody-negative, fewer participants in the teplizumab group than in the placebo group had diabetes diagnosed', '76 participants (55 [72%] of whom were ≤18 years of age) underwent randomization - 44 to the teplizumab group and 32 to the', 'relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease']","['teplizumab or placebo', 'teplizumab', 'teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody', 'placebo']","['median time to the diagnosis of type 1 diabetes', 'hazard ratio', 'TIGIT+KLRG1+CD8+ T cells', 'adverse events of rash and transient lymphopenia', 'annualized rates of diagnosis of diabetes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019772', 'cui_str': 'HLA-DR3'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0019774', 'cui_str': 'HLA-DR4'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495784', 'cui_str': 'Anti-ZnT8 antibody negative'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C2743673', 'cui_str': 'humanized OKT3 gamma1(Ala-Ala)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2743673', 'cui_str': 'humanized OKT3 gamma1(Ala-Ala)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034805', 'cui_str': 'Fc Receptor'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}]",76.0,0.430173,TIGIT+KLRG1+CD8+ T cells were more common in the teplizumab group than in the placebo group.,"[{'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Bundy', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'S Alice', 'Initials': 'SA', 'LastName': 'Long', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bluestone', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'DiMeglio', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Dufort', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Linsley', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Marks', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Moore', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Moran', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rodriguez', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Russell', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Schatz', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tsalikian', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Wherrett', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Anette-Gabriele', 'Initials': 'AG', 'LastName': 'Ziegler', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Greenbaum', 'Affiliation': ""From the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.); the Departments of Epidemiology and Pediatrics, University of South Florida, Tampa (B.N.B., J.P.K., H.R.), the Department of Medicine, University of Miami, Miami (J.B.M., J.S.S.), and the Department of Pediatrics, University of Florida, Gainesville (D.S.) - all in Florida; Benaroya Research Institute, Seattle (S.A.L., M.J.D., P.S.L., C.J.G.); the Diabetes Center, University of California at San Francisco, San Francisco (J.A.B., S.E.G.); the Department of Pediatrics, Indiana University, Indianapolis (L.A.D.); the Barbara Davis Diabetes Center, University of Colorado, Anschultz (P.A.G.); Children's Mercy Hospital, Kansas City, MO (W.M.); the Department of Pediatrics, University of Minnesota, Minneapolis (A.M.); the Department of Pediatrics and Cell and Developmental Biology, Vanderbilt University, Nashville (W.E.R.); the Department of Pediatrics, University of Iowa, Iowa City (E.T.); the Hospital for Sick Children, University of Toronto, Toronto (D.K.W.); and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany (A.-G.Z.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1902226']
564,30923036,Immunotherapy of Melanoma: Facts and Hopes.,"Melanoma is among the most sensitive of malignancies to immune modulation. Although multiple trials conducted over decades with vaccines, cytokines, and cell therapies demonstrated meaningful responses in a small subset of patients with metastatic disease, a true increase in overall survival (OS) within a randomized phase III trial was not observed until the development of anti-CTLA-4 (ipilimumab). Further improvements in OS for metastatic disease were observed with the anti-PD-1-based therapies (nivolumab, pembrolizumab) as single agents or combined with ipilimumab. A lower bound for expected 5-year survival for metastatic melanoma is currently approximately 35% and could be as high as 50% for the nivolumab/ipilimumab combination among patients who would meet criteria for clinical trials. Moreover, a substantial fraction of long-term survivors will likely remain progression-free without continued treatment. The hope and major challenge for the future is to understand the immunobiology of tumors with primary or acquired resistance to anti-PD-1 or anti-PD-1/anti-CTLA-4 and to develop effective immune therapies tailored to individual patient subsets not achieving long-term clinical benefit. Additional goals include optimal integration of immune therapy with nonimmune therapies, the development and validation of predictive biomarkers in the metastatic setting, improved prognostic and predictive biomarkers for the adjuvant setting, understanding mechanisms of and decreasing toxicity, and optimizing the duration of therapy.",2019,"Further improvements in OS for metastatic disease were observed with the anti-PD-1-based therapies (nivolumab, pembrolizumab) as single agents or combined with ipilimumab.",[],['ipilimumab'],"['5-year survival', 'overall survival (OS']",[],"[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0690909,"Further improvements in OS for metastatic disease were observed with the anti-PD-1-based therapies (nivolumab, pembrolizumab) as single agents or combined with ipilimumab.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Weiss', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut. sarah.a.weiss@yale.edu.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-1550']
565,30386978,Communicating Actively Responding Empathically (CARE): Comparison of Communication Training Workshops for Health Professionals Working in Cancer Care.,"Accessing full-day communication skills training can be challenging for health professionals working in cancer care. This study aimed to examine the effectiveness of Communicating Actively, Responding Empathically (CARE Express), a modified 2-h communication skills training course, across measures of health professional confidence, skills and attitudes. Cancer care health professionals (n = 147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms: control, two-hour training (CARE Express) and 1-day training (CARE). Perceived confidence and skills were measured by self-report using a purpose-built scale, and written responses to a challenging clinical encounter were obtained at baseline, post-training and three-months post-training. Attitudes toward psychosocial issues were evaluated with the Physician Belief Scale at baseline and 3 months post-training. No changes were observed in the control group (n = 50) from baseline to 3 months follow-up. Participants in the CARE Express (n = 48) and CARE (n = 49) groups had significant improvement in confidence in identifying/responding to emotions between baseline and 3 months post-training (p < 0.001), as well as their attitude toward psychosocial care (p < 0.001). A significant increase in ""acknowledging"" responses from baseline to 3 months was also observed for CARE Express and CARE (p < 0.001), with no difference between groups. CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training. Whilst the 1-day workshop has been regarded as gold standard, this study has revealed positive outcomes with a modified 2-h version, thus offering a potential alternate training model.",2020,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","['Participants in the CARE Express (n\u2009=\u200948) and CARE (n\u2009', 'Cancer care health professionals (n\u2009=\u2009147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms', 'Health Professionals Working in Cancer Care']","['Communication Training Workshops', 'control, two-hour training (CARE Express) and 1-day training (CARE']","['acknowledging"" responses', 'attitude toward psychosocial care', 'Perceived confidence and skills', 'health professional confidence, skills and attitudes', 'Physician Belief Scale', 'confidence in identifying/responding to emotions', 'confidence in emotional identification/response, psychosocial focus and communication skills']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0222045'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",147.0,0.0210218,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","[{'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia. jodie.nixon@health.qld.gov.au.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': 'QFAB Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Scaife', 'Affiliation': 'Cancer Services, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Bena', 'Initials': 'B', 'LastName': 'Cartmill', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Australia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1439-0']
566,30404548,A mixed-methods process evaluation of Family Navigation implementation for autism spectrum disorder.,"There is growing interest in Family Navigation as an approach to improving access to care for children with autism spectrum disorder, yet little data exist on the implementation of Family Navigation. The aim of this study was to identify potential failures in implementing Family Navigation for children with autism spectrum disorder, using a failure modes and effects analysis. This mixed-methods study was set within a randomized controlled trial testing the effectiveness of Family Navigation in reducing the time from screening to diagnosis and treatment for autism spectrum disorder across three states. Using standard failure modes and effects analysis methodology, experts in Family Navigation for autism spectrum disorder (n = 9) rated potential failures in implementation on a 10-point scale in three categories: likelihood of the failure occurring, likelihood of  not  detecting the failure, and severity of failure. Ratings were then used to create a risk priority number for each failure. The failure modes and effects analysis detected five areas for potential ""high priority"" failures in implementation: (1) setting up community-based services, (2) initial family meeting, (3) training, (4) fidelity monitoring, and (5) attending testing appointments. Reasons for failure included families not receptive, scheduling, and insufficient training time. The process with the highest risk profile was ""setting up community-based services."" Failure in ""attending testing appointment"" was rated as the most severe potential failure. A number of potential failures in Family Navigation implementation-along with strategies for mitigation-were identified. These data can guide those working to implement Family Navigation for children with autism spectrum disorder.",2019,"There is growing interest in Family Navigation as an approach to improving access to care for children with autism spectrum disorder, yet little data exist on the implementation of Family Navigation.","['autism spectrum disorder', 'children with autism spectrum disorder']","['Family Navigation implementation', 'implementing Family Navigation', 'Family Navigation']",[' Failure'],"[{'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0747241,"There is growing interest in Family Navigation as an approach to improving access to care for children with autism spectrum disorder, yet little data exist on the implementation of Family Navigation.","[{'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': '1 Boston University School of Medicine, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""2 The Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Goupil', 'Affiliation': ""2 The Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': ""2 The Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Augustyn', 'Affiliation': '1 Boston University School of Medicine, USA.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Blum', 'Affiliation': '3 Boston Medical Center, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': '3 Boston Medical Center, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Weitzman', 'Affiliation': '4 Yale School of Medicine, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Guevara', 'Affiliation': '3 Boston Medical Center, USA.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Fenick', 'Affiliation': '4 Yale School of Medicine, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': '1 Boston University School of Medicine, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': '1 Boston University School of Medicine, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361318808460']
567,30596812,"Weekly paclitaxel, carboplatin, cetuximab, and cetuximab, docetaxel, cisplatin, and fluorouracil, followed by local therapy in previously untreated, locally advanced head and neck squamous cell carcinoma.","BACKGROUND


The survival advantage of induction chemotherapy (IC) followed by locoregional treatment is controversial in locally advanced head and neck squamous cell carcinoma (LAHNSCC). We previously showed feasibility and safety of cetuximab-based IC (paclitaxel/carboplatin/cetuximab-PCC, and docetaxel/cisplatin/5-fluorouracil/cetuximab-C-TPF) followed by local therapy in LAHNSCC. The primary end point of this phase II clinical trial with randomization to PCC and C-TPF followed by combined local therapy in patients with LAHNSCC stratified by human papillomavirus (HPV) status and T-stage was 2-year progression-free survival (PFS) compared with historical control.
PATIENTS AND METHODS


Eligible patients were ≥18 years with squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx with measurable stage IV (T0-4N2b-2c/3M0) and known HPV by p16 status. Stratification was by HPV and T-stage into one of the two risk groups: (i) low-risk: HPV-positive and T0-3 or HPV-negative and T0-2; (ii) intermediate/high-risk: HPV-positive and T4 or HPV-negative and T3-4. Patient reported outcomes were carried out.
RESULTS


A total of 136 patients were randomized in the study, 68 to each arm. With a median follow up of 3.2 years, the 2-year PFS in the PCC arm was 89% in the overall, 96% in the low-risk and 67% in the intermediate/high-risk groups; in the C-TPF arm 2-year PFS was 88% in the overall, 88% in the low-risk and 89% in the intermediate/high-risk groups.
CONCLUSION


The observed 2-year PFS of PCC in the low-risk group and of C-TPF in the intermediate/high-risk group showed a 20% improvement compared with the historical control derived from RTOG-0129, therefore reaching the primary end point of the trial.",2019,"The observed 2-year PFS of PCC in the low-risk group and of C-TPF in the intermediate/high-risk group showed a 20% improvement compared with the historical control derived from RTOG-0129, therefore reaching the primary end point of the trial.","['locally advanced head and neck squamous cell carcinoma (LAHNSCC', 'Eligible patients were ≥18\u2009years with squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx with measurable stage IV (T0-4N2b-2c/3M0) and known HPV by p16 status', 'patients with LAHNSCC stratified by human papillomavirus (HPV) status and T-stage was', 'A total of 136 patients were randomized in the study, 68 to each arm', 'previously untreated, locally advanced head and neck squamous cell carcinoma']","['Weekly paclitaxel, carboplatin, cetuximab, and cetuximab, docetaxel, cisplatin, and fluorouracil, followed by local therapy', 'cetuximab-based IC (paclitaxel/carboplatin/cetuximab-PCC, and docetaxel/cisplatin/5-fluorouracil/cetuximab-C-TPF', 'induction chemotherapy (IC']","['2-year PFS of PCC', '2-year progression-free survival (PFS', '2-year PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0020629', 'cui_str': 'Laryngopharynx'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0249880', 'cui_str': 'Cyclin-Dependent Kinase Inhibitor p16'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",136.0,0.0606806,"The observed 2-year PFS of PCC in the low-risk group and of C-TPF in the intermediate/high-risk group showed a 20% improvement compared with the historical control derived from RTOG-0129, therefore reaching the primary end point of the trial.","[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Massarelli', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston; Department of Medical Oncology and Therapeutics Research, City of Hope Cancer Center, Duarte.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Departments of Biostatistics.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Departments of Biostatistics.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hutcheson', 'Affiliation': 'Head and Neck Surgery.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Garden', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'W N', 'Initials': 'WN', 'LastName': 'William', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston; Oncology Center, Hospital BP, A Beneficencia Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Pharaon', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope Cancer Center, Duarte.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Tishler', 'Affiliation': 'Department of Radiation Oncology, Dana Farber Cancer Institute, Boston.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Glisson', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pickering', 'Affiliation': 'Head and Neck Surgery.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Gold', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston; Division of Hematology and Oncology, University of California San Diego Moores Cancer Center, La Jolla.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Johnson', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rabinowits', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston; Department of Head and Neck Oncology, Baptist Health South Florida, Coral Gables.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Ginsberg', 'Affiliation': 'Departments of Diagnostic Radiology.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Williams', 'Affiliation': 'Pathology, University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Head and Neck Surgery.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kies', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston. Electronic address: vpapadim@mdanderson.org.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy549']
568,32402161,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,"BACKGROUND


Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.
METHODS


We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of  Lactobacillus crispatus  CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.
RESULTS


A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.
CONCLUSIONS


The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).",2020,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","['228 women underwent randomization: 152 to the Lactin-V group and 76 to the', 'Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements']","['vaginal metronidazole', 'vaginally administered Lactin-V or placebo', 'Lactobacillus crispatus  CTV-05 (Lactin-V', 'Lactin-V', 'placebo']","['recurrence of bacterial vaginosis', 'risk ratio for recurrence', 'percentage of women who had a recurrence of bacterial vaginosis', 'percentage of participants with local or systemic adverse events', 'Recurrence of Bacterial Vaginosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317614', 'cui_str': 'Lactobacillus crispatus'}, {'cui': 'C0454198', 'cui_str': 'Clinical target volume'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",228.0,0.642452,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","[{'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'French', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Newmann', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Reno', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hemmerling', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915254']
569,32152156,Safetxt: a safer sex intervention delivered by mobile phone messaging on sexually transmitted infections (STI) among young people in the UK - protocol for a randomised controlled trial.,"INTRODUCTION


Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK.
METHODS AND ANALYSIS


A single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners.
ETHICS AND DISSEMINATION


Ethics approval was obtained from NHS Health Research Authority - London - Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


International Standard Randomised Controlled Trials Number: ISRCTN64390461. Registered on 17 th  March 2016.  WHO trial registration data set  available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.
TRIAL PROTOCOL VERSION


12, 19 th  July 2018.",2020,"INTRODUCTION


Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high.","['Young people aged 16 to 24', '12, 19 th  July 2018', 'young people in the UK', '6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK']","['safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing', 'safetxt intervention', 'safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system', 'mobile phone messaging']","['partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners', 'cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests', 'chlamydia and gonorrhoea infection']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0041976', 'cui_str': 'Urethritis'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0079990', 'cui_str': 'Notification, Partner'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}]","[{'cui': 'C0079990', 'cui_str': 'Notification, Partner'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0200932', 'cui_str': 'Nucleic Acid Amplification Tests'}]",6250.0,0.307453,"INTRODUCTION


Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK caroline.free@lshtm.ac.uk.'}, {'ForeName': 'Ona L', 'Initials': 'OL', 'LastName': 'McCarthy', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Palmer', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Clinical Trials Unit, MSD, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'French', 'Affiliation': 'Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Baraitser', 'Affiliation': ""Centre for Global Health, King's College London, London, London, UK.""}, {'ForeName': 'Ford Colin Ian', 'Initials': 'FCI', 'LastName': 'Hickson', 'Affiliation': 'Sigma Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Wellings', 'Affiliation': 'Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Julia V', 'Initials': 'JV', 'LastName': 'Bailey', 'Affiliation': 'Primary Care and Population Health, University College London, London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hart', 'Affiliation': 'Department of Infection and Population Health, University College London, London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Outcomes Research and Effectivenes, University College London, London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Clayton', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Ploubidis', 'Affiliation': 'Department of Social Science, University College London Institute of Education, London, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Carpenter', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Katy M E', 'Initials': 'KME', 'LastName': 'Turner', 'Affiliation': 'Bristol Vetinary School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Devries', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031635']
570,32144883,Prefrontal Cortex Neuromodulation Enhances Frontal Asymmetry and Reduces Caloric Intake in Patients with Morbid Obesity.,"OBJECTIVE


The objective of this study was to test the feasibility of a combined intervention involving transcranial direct current stimulation (tDCS) on the dorsolateral prefrontal cortex (dlPFC) and cognitive training (CT). Short-term effects on food consumption, cognition, endocannabinoid (eCB) levels, and electroencephalogram (EEG) markers of future weight loss were explored.
METHODS


Eighteen healthy volunteers with morbid obesity were randomized in a double-blind, placebo-controlled, parallel trial. Participants received sham or active tDCS plus CT for four consecutive days. Cognitive performance, daily food intake, and eCB blood samples were collected before and after the intervention; EEG data were gathered before and after daily training.
RESULTS


The active tDCS + CT group reversed left-dominant frontal asymmetry and increased frontal coherence (FC) in the γ-band (30-45 Hz) after the intervention. The strength of the latter predicted BMI reduction. Additionally, a large intervention effect on food intake was shown in the active tDCS + CT group at follow-up (-339.6 ± 639 kcal on average), and there was a decrease of plasma eCB concentrations.
CONCLUSIONS


dlPFC modulation through tDCS + CT is an effective tool to restore right dominance of the dlPFC and enhance FC in patients with morbid obesity. Moreover, the effect of the strength of FC on BMI suggests that the interhemispheric FC at the dlPFC is functionally relevant for the efficient regulation of food choice.",2020,"Additionally, a large intervention effect on food intake was shown in the active tDCS + CT group at follow-up (-339.6 ± 639 kcal on average), and there was a decrease of plasma eCB concentrations.
","['patients with morbid obesity', 'Patients with Morbid Obesity', 'Eighteen healthy volunteers with morbid obesity']","['cognitive training (CT', 'combined intervention involving transcranial direct current stimulation (tDCS', 'tDCS\u2009+\u2009CT', 'sham or active tDCS plus CT', 'placebo', 'Prefrontal Cortex Neuromodulation Enhances Frontal Asymmetry']","['Cognitive performance, daily food intake, and eCB blood samples', 'food intake', 'food consumption, cognition, endocannabinoid (eCB) levels, and electroencephalogram (EEG)\xa0markers of future weight loss', 'plasma eCB concentrations', 'Caloric Intake', 'left-dominant frontal asymmetry and increased frontal coherence (FC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",18.0,0.0381687,"Additionally, a large intervention effect on food intake was shown in the active tDCS + CT group at follow-up (-339.6 ± 639 kcal on average), and there was a decrease of plasma eCB concentrations.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forcano', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Castellano', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Cuenca-Royo', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday-Arno', 'Affiliation': 'Morbid Obesity Care Unit, IMIM-Hospital del Mar Medical Research Institute Barcelona, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Pastor', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Langohr', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Karla Alejandra', 'Initials': 'KA', 'LastName': 'Pérez-Vega', 'Affiliation': 'Unit of Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Serra', 'Affiliation': 'Morbid Obesity Care Unit, IMIM-Hospital del Mar Medical Research Institute Barcelona, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Harvard University, Boston, Massachusetts, USA.'}, {'ForeName': 'Aureli', 'Initials': 'A', 'LastName': 'Soria-Frisch', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Torre', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22745']
571,32193264,Influence of combined vitamin D 3  supplementation and resistance exercise training on musculoskeletal health in older men and women (EXVITD): protocol for a randomised controlled trial.,"INTRODUCTION


Sarcopenia is a progressive loss in muscle mass, strength and function, the adverse consequences of which are severe, affecting quality of life and placing an increasing burden on social and healthcare systems. Vitamin D status is known to be associated with markers of sarcopenia, namely muscle mass, strength and function. Also, resistance exercise training (RET) is currently the only proven intervention to treat sarcopenia. However, very little data exist on the influence of combining the two interventions of vitamin D supplementation and resistance exercise training, although a recent systematic review provides tentative support for the current study's hypothesis that the combined intervention may further improve musculoskeletal function above exercise training alone. The aim of the present study is to determine whether vitamin D 3  supplementation is any more effective in improving musculoskeletal function when combined with RET compared with exercise training alone in older adults.
METHODS AND ANALYSIS


This double-blinded randomised placebo-controlled trial will recruit a target of 127 eligible men and women aged ≥65 years living independently or in sheltered housing within the Birmingham area to two groups: (1) 6 months RET and placebo or (2) 6 months RET and 800 IU/d vitamin D 3 . Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed. Assessments will take place at baseline and postintervention, with intermittent monitoring of bone turnover, calcium and vitamin D. The primary outcome will be lower limb extensor power output. Analyses of within-group changes and between-group differences in outcome measures are planned.
ETHICS AND DISSEMINATION


The EXVITD study has ethical approval granted by the Black Country National Health Service Research Ethics Committee (14/WM/1220). Results of this trial will be submitted for publication in peer-reviewed journals and presented at conferences. The study is being conducted according to the principles of the Declaration of Helsinki. Trial registration number NCT02467153; Post-results.",2020,"Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed.","['older men and women (EXVITD', 'or (2) 6 months RET and 800\u2009IU', '127 eligible men and women aged ≥65 years living independently or in sheltered housing within the Birmingham area to two groups: (1) 6 months', 'older adults']","['resistance exercise training (RET', 'vitamin D 3  supplementation', 'calcium and vitamin D', 'RET and placebo', 'placebo', 'vitamin D supplementation and resistance exercise training', 'exercise training alone', 'combined vitamin D 3  supplementation and resistance exercise training']","['lower limb extensor power output', 'musculoskeletal health', 'muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events', 'musculoskeletal function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587731', 'cui_str': 'Sheltered housing (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal Physiological Concepts'}]",,0.294362,"Measures of muscle power (Nottingham Power Rig), body composition (dual energy X-ray absorptiometry), muscle function (short physical performance battery, timed up and go), falls and fractures as events will be assessed.","[{'ForeName': 'Anneka Elizabeth', 'Initials': 'AE', 'LastName': 'Welford', 'Affiliation': 'School of Sports, Exericse and Rehabilitation Sciences, University of Birmingham, Birmingham, UK aea423@bham.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lanham-New', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Surrey, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lord', 'Affiliation': 'MRC-Arthritis UK Centre for Musculoskeletal Ageing Research, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Doyle', 'Affiliation': 'The Royal Osteoporosis Society, Bath, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Move it or Lose it, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gittoes', 'Affiliation': 'Centre for Endocrinology, Diabetes and Metabolism, Queen Elizabeth Hospital Birmingham, Birmingham, Birmingham, UK.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Greig', 'Affiliation': 'MRC-Versus Arthritis Centre for Musculoskeletal Ageing Research, MRC-Arthritis Research UK Centre for Musculoskeletal Ageing Research, Birmingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033824']
572,32102708,"Associations between enteric pathogen carriage and height-for-age, weight-for-age and weight-for-height in children under 5 years old in urban Dhaka, Bangladesh.","Nutritional factors and infectious agents may contribute to paediatric growth deficits in low- and middle-income countries; however, the contribution of enteric pathogens is only beginning to be understood. We analysed the stool from children <5 years old from an open cohort, cluster-randomised controlled trial of a point-of-collection water chlorinator in urban Bangladesh. We compared the presence/absence of 15 enteric pathogens detected via multiplex, molecular methods in the stool with concurrent Z-scores/Z-score cut-offs (-2 standard deviations (s.d.)) for height-for-age (HAZ/stunting), weight-for-age (WAZ/underweight) and weight-for-height (WHZ/wasting), adjusted for sociodemographic and trial-related factors, and measured caregiver-reported diarrhoea. Enteric pathogen prevalence in the stool was high (88% had ≥1 enteric pathogen, most commonly Giardia spp. (40%), Salmonella enterica (33%), enterotoxigenic E. coli (28%) and Shigella spp. (27%)) while reported 7-day diarrhoea prevalence was 6%, suggesting high subclinical infection rates. Many children were stunted (26%) or underweight (24%). Adjusted models suggested Giardia spp. detection was associated with lower HAZ (-0.22 s.d., 95% CI -0.44 to 0.00; prevalence ratio for stunting: 1.39, 95% CI 0.94-2.06) and potentially lower WAZ. No pathogens were associated with reported diarrhoea in adjusted models. Giardia spp. carriage may be associated with growth faltering, but not diarrhoea, in this and similar low-income settings. Stool-based enteric pathogen detection provides a direct indication of previous exposure that may be useful as a broader endpoint of trials of environmental interventions.",2020,"Enteric pathogen prevalence in the stool was high (88% had ≥1 enteric pathogen, most commonly Giardia spp.","['children under 5 years old in urban Dhaka, Bangladesh', 'children <5 years old from an open cohort, cluster-randomised controlled trial of a point-of-collection water chlorinator in urban Bangladesh']",[],"['Salmonella enterica', 'Enteric pathogen prevalence', 'diarrhoea', '7-day diarrhoea prevalence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0043047', 'cui_str': 'Water'}]",[],"[{'cui': 'C0445750', 'cui_str': 'Salmonella enterica'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.160984,"Enteric pathogen prevalence in the stool was high (88% had ≥1 enteric pathogen, most commonly Giardia spp.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berendes', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Capone', 'Affiliation': 'School of Civil and Environmental Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Knee', 'Affiliation': 'School of Civil and Environmental Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holcomb', 'Affiliation': 'Department of Environmental Sciences and Engineering, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sultana', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'School of Engineering, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'School of Civil and Environmental Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}]",Epidemiology and infection,['10.1017/S0950268820000369']
573,30842213,Effect of acute exercise on postprandial endothelial function in postmenopausal women: a randomized cross-over study.,"High-sugar intake may cause endothelial dysfunction. It is unknown if a bout of aerobic exercise improves endothelial dysfunction caused by a high-sugar meal in postmenopausal women. This study evaluated if prior aerobic exercise attenuates postprandial endothelial dysfunction in postmenopausal women. Twenty-two postmenopausal women (age [mean±SD]: 60.4±6.5 years; % body fat: 40.3%±7.5%) underwent an exercise (EX) or no exercise (NE) condition, in a random order, 13-16 hours prior to the high-sugar meal consumption. The EX condition included a 60 min bout of supervised aerobic exercise at 75% of age-predicted maximum heart rate. The high-sugar meal, consumed after a 12-hour fast, contained 33% of the subjects' daily energy needs, and 75.6% energy from carbohydrates. Flow-mediated dilation (FMD) and blood concentrations of glucose, insulin, endothelin-1 (ET-1), and nitric oxide (NO) were assessed at baseline and 60 min, 120 min, and 180 min postprandially. Repeated measures analysis test showed that there were no condition by time interaction or condition effects for FMD, glucose, insulin, or NO. There was a significant condition by time interaction but no condition effect for ET-1. Area under the curve was also not different by condition for insulin sensitivity or the above variables. In conclusion, prior aerobic exercise compared with NE did not affect FMD, blood glucose, insulin, ET-1 or NO concentrations, or insulin sensitivity following a high-sugar meal in postmenopausal women. Future studies should look at the effect of different EX intensities on meal-induced endothelial dysfunction in this population.  Trial Registration : ClinicalTrials.gov Identifier: NCT02919488.",2019,"Repeated measures analysis test showed that there were no condition by time interaction or condition effects for FMD, glucose, insulin, or NO.","['postmenopausal women', 'Twenty-two postmenopausal women (age [mean±SD]: 60.4±6.5\u2009years; % body fat: 40.3%±7.5']","['aerobic exercise', 'supervised aerobic exercise', 'acute exercise', 'exercise (EX) or no exercise (NE) condition']","['Flow-mediated dilation (FMD) and blood concentrations of glucose, insulin, endothelin-1 (ET-1), and nitric oxide (NO', 'postprandial endothelial dysfunction', 'endothelial dysfunction', 'FMD, blood glucose, insulin, ET-1 or NO concentrations, or insulin sensitivity', 'time interaction or condition effects for FMD, glucose, insulin, or NO', 'postprandial endothelial function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",22.0,0.0664689,"Repeated measures analysis test showed that there were no condition by time interaction or condition effects for FMD, glucose, insulin, or NO.","[{'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Kinesiology, Texas Christian University, Fort Worth, Texas, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Kinesiology, Texas Christian University, Fort Worth, Texas, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gloeckner', 'Affiliation': 'Kinesiology, Texas Christian University, Fort Worth, Texas, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kreutzer', 'Affiliation': 'Kinesiology, Texas Christian University, Fort Worth, Texas, USA.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Adams-Huet', 'Affiliation': 'Clinical Sciences, UT Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cheek', 'Affiliation': 'Nursing, Texas Christian University, Fort Worth, Texas, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Kinesiology, Texas Christian University, Fort Worth, Texas, USA.'}]",Journal of investigative medicine : the official publication of the American Federation for Clinical Research,['10.1136/jim-2019-000992']
574,32402702,Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.,"BACKGROUND


Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients.
METHODS


The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
RESULTS


More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea.
CONCLUSION


This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.",2020,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","['high-risk PCI patients', 'high-risk patients who underwent percutaneous coronary intervention', 'patients with high-risk anatomic or clinical characteristics who underwent PCI', '1700 high-risk PCI patients']","['routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing', 'routine versus no routine functional testing', 'percutaneous coronary intervention (PCI) with drug-eluting stents (DES']","['composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0562340', 'cui_str': 'Poor daily routine'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",,0.0929061,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","[{'ForeName': 'Yong-Hoon', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Cheol', 'Initials': 'SC', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Won-Jang', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Chul Soo', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': ""Cardiovascular Center and Cardiology Division, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bong-Ki', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Kangwon National University Hospital, Chuncheon, Republic of Korea.'}, {'ForeName': 'Jung-Won', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Wonju Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Eulji General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Sik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Su Nam', 'Initials': 'SN', 'LastName': 'Lee', 'Affiliation': ""Division of Cardiology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: dwpark@amc.seoul.kr.'}]",American heart journal,['10.1016/j.ahj.2020.03.019']
575,32404343,Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study.,"OBJECTIVE


To investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission.
METHODS


The PREDICTRA phase IV, randomised, double-blind (DB) study (Im P act of  R esidual Inflammation Detected via Imaging T E chniques,  D rug Levels, and Patient Characteristics on the Outcome of Dose Taper I ng of Adalimumab in  C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40 mg every other week who were in sustained remission ≥6 months. After a 4-week, open-label lead-in (OL-LI) period, patients were randomised 5:1 to DB adalimumab taper (every 3 weeks) or withdrawal (placebo) for 36 weeks. The primary endpoint was the association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence.
RESULTS


Of 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies.
CONCLUSIONS


Approximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence.
TRIAL REGISTRATION NUMBER


NCT02198651, EudraCT 2014-001114-26.",2020,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"['patients with rheumatoid arthritis (RA) in sustained remission', 'Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission', 'C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40\u2009mg every other week who were in sustained remission ≥6 months', '146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms', 'patients with rheumatoid arthritis who are in long-standing clinical remission']","['DB adalimumab taper (every 3 weeks) or withdrawal (placebo', 'adalimumab tapering or withdrawal', 'Adalimumab', 'tapered adalimumab']","['association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence', 'Baseline MRI inflammation', 'DB baseline disease characteristics or adalimumab concentration', 'clinical remission', 'Time to flare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0412709', 'cui_str': 'MRI of wrist'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.196623,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK p.emery@leeds.ac.uk.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Naredo', 'Affiliation': 'Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Sinigaglia', 'Affiliation': 'Department of Rheumatology and Medical Sciences, Centro Specialistico Ortopedico Traumatologico Pini-CTO, Milan, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lagunes', 'Affiliation': 'Global Medical Affairs Rheumatology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Koenigsbauer', 'Affiliation': 'Data and Statistical Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217246']
576,32067873,Effect of an Intervention for Obesity and Depression on Patient-Centered Outcomes: An RCT.,"INTRODUCTION


An integrated collaborative care intervention was successful for treating comorbid obesity and depression. The effect of the integrated intervention on secondary outcomes of quality of life and psychosocial functioning were examined, as well as whether improvements in these secondary outcomes were correlated with improvements in the primary outcomes of weight and depressive symptoms.
STUDY DESIGN


This RCT compared an integrated collaborative care intervention for obesity and depression to usual care. Data were analyzed in 2018.
SETTING/PARTICIPANTS


Adult primary care patients (n=409) with a BMI ≥30 (≥27 if Asian) and 9-Item Patient Health Questionnaire score ≥10 were recruited from September 30, 2014 to January 12, 2017 from primary care clinics in Northern California.
INTERVENTION


The 12-month intervention integrated a behavioral weight loss program and problem-solving therapy with as-needed antidepressant medications for depression.
MAIN OUTCOME MEASURES


A priori secondary outcomes included health-related quality of life (Short Form-8 Health Survey), obesity-specific quality of life (Obesity-Related Problems Scale), sleep disturbance and sleep-related impairment (Patient-Reported Outcomes Measurement Information System), and functional disability (Sheehan Disability Scale) at baseline and 6 and 12 months.
RESULTS


Participants randomized to the intervention experienced significantly greater improvements in obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability at 6 months but not 12 months. Improvements in obesity-related problems (β=0.01, 95% CI=0.01, 0.02) and sleep disturbance (β= -0.02, 95% CI= -0.04, 0) were associated with lower BMI. Improvements in the physical (β= -0.01, 95% CI= -0.01, 0) and mental health components (β= -0.02, 95% CI= -0.03, -0.02) of the Short Form-8 Health Survey as well as sleep disturbance (β=0.01, 95% CI=0.01, 0.02) and sleep-related impairment (β=0.01, 95% CI=0, 0.01) were associated with fewer depressive symptoms.
CONCLUSIONS


An integrated collaborative care intervention for obesity and depression that was shown previously to improve weight and depressive symptoms may also confer benefits for quality of life and psychosocial functioning over 6 months.
TRIAL REGISTRATION


This study is registered at clinicaltrials.gov NCT02246413.",2020,"RESULTS


Participants randomized to the intervention experienced significantly greater improvements in obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability at 6 months but not 12 months.","['Adult primary care patients (n=409) with a BMI ≥30 (≥27 if Asian) and 9-Item Patient Health Questionnaire score ≥10 were recruited from September 30, 2014 to January 12, 2017 from primary care clinics in Northern California']","['integrated intervention', 'integrated collaborative care intervention', 'behavioral weight loss program and problem-solving therapy with as-needed antidepressant medications']","['sleep disturbance', 'health-related quality of life (Short Form-8 Health Survey), obesity-specific quality of life (Obesity-Related Problems Scale), sleep disturbance and sleep-related impairment (Patient-Reported Outcomes Measurement Information System), and functional disability (Sheehan Disability Scale', 'quality of life and psychosocial functioning', 'sleep-related impairment', 'mental health components', 'depressive symptoms', 'obesity-related problems', 'weight and depressive symptoms', 'obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",0.0,0.14691,"RESULTS


Participants randomized to the intervention experienced significantly greater improvements in obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability at 6 months but not 12 months.","[{'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, California; Department of Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Kristen M J', 'Initials': 'KMJ', 'LastName': 'Azar', 'Affiliation': 'Sutter Health Research, Sutter Health, Palo Alto, California.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Department of Medicine and Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, California.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Medicine and Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois. Electronic address: maj2015@uic.edu.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.11.005']
577,32197884,A training program to prepare exercise coaches for delivery of the HEART camp intervention to patients with heart failure.,,2020,,['patients with heart failure'],['HEART camp intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]",[],,0.0113118,,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Duncan', 'Affiliation': 'University of Nebraska Medical Center-College of Nursing, Omaha, NE, United States of America. Electronic address: kduncan@unmc.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'McGuire', 'Affiliation': 'University of Nebraska Medical Center-College of Nursing, Omaha, NE, United States of America.'}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': 'University of Nebraska Medical Center-College of Nursing, Omaha, NE, United States of America.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151226']
578,32197956,"Randomized Trial on the Effects of High-Dose Zopiclone on OSA Severity, Upper Airway Physiology, and Alertness.","BACKGROUND


Studies indicate that standard doses of hypnotics reduce or do not change the apnea-hypopnea index (AHI) or pharyngeal muscle activity. A 1-month trial of nightly zopiclone (7.5 mg) modestly reduced the AHI vs baseline without changing other sleep parameters or next-day sleepiness.
RESEARCH QUESTION


This study aimed to determine the effects of high-dose zopiclone (15 mg) on AHI, arousal threshold, genioglossus muscle responsiveness, and next-day alertness in selected people with OSA (low to moderate arousal thresholds without major overnight hypoxemia). We hypothesized that high-dose zopiclone would yield greater increases in arousal threshold and therefore larger reductions in AHI but may come at the expense of increased hypoxemia and next-day impairment.
STUDY DESIGN AND METHODS


Twenty-eight participants (AHI = 29 ± 20 events/h) suspected to have low to moderate arousal thresholds were studied during two in-laboratory polysomnographies, separated by 1 week, with an epiglottic pressure catheter and genioglossus intramuscular electrodes. Participants received 15 mg of zopiclone or placebo at each visit according to a double-blind, randomized, crossover design. Each morning, subjective sleepiness and alertness via a driving simulator task were assessed.
RESULTS


The AHI did not change from placebo to zopiclone (-1.5 events/h; 95% CI, -6.6 to 3.5 events/h; P = .54). Arousal threshold, genioglossus muscle responsiveness, and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
INTERPRETATION


A single night of treatment with high-dose zopiclone does not systematically reduce the AHI or increase the arousal threshold in selected people with OSA. The mechanisms for these unexpected findings require further investigation.
TRIAL REGISTRY


Australian New Zealand Clinical Trials Registry; No.: ACTRN12617000988358; URL: https://www.anzctr.org.au.",2020,"Arousal threshold, genioglossus muscle responsiveness and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
","['selected people with obstructive sleep apnea (OSA) (low-moderate arousal thresholds without major overnight hypoxemia', 'and methods: 28 participants (AHI=29±20events/h) suspected to have low-moderate arousal thresholds']","['high-dose zopiclone', 'zopiclone or placebo', 'epiglottic pressure catheter and genioglossus intramuscular electrodes', 'nightly zopiclone']","['AHI, arousal threshold, genioglossus muscle responsiveness and next-day alertness', 'Arousal threshold, genioglossus muscle responsiveness', 'subjective sleepiness and alertness via a driving simulator task', 'OSA severity, upper airway physiology and alertness', 'apnea-hypopnea index (AHI) or pharyngeal muscle activity', 'sleep parameters and measures of next-day sleepiness and alertness']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0031346', 'cui_str': 'Muscles of Pharynx'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.288769,"Arousal threshold, genioglossus muscle responsiveness and most other sleep parameters and measures of next-day sleepiness and alertness also did not change with zopiclone.
","[{'ForeName': 'Sophie G', 'Initials': 'SG', 'LastName': 'Carter', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW. Electronic address: s.carter@neura.edu.au.'}, {'ForeName': 'Jayne C', 'Initials': 'JC', 'LastName': 'Carberry', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW; Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Woolcock Institute of Medical Research and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, NSW; Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA.'}]",Chest,['10.1016/j.chest.2020.02.057']
579,32202333,"Correlations among pain, depressive symptoms, constipation, and serotonin levels in smokers and non smokers.","PURPOSE


To examine the differences and correlations among pain, depressive symptoms, and constipation in smokers and non smokers.
DESIGN AND METHODS


The present study was a cross-sectional study that used descriptive correlations. This study was a secondary analysis of a randomized clinical trial.
FINDINGS


Smokers had more pain, depressive symptoms, and constipation than non smokers. Smokers had similar serotonin levels compared with non smokers. Positive correlations were observed between constipation and serum serotonin levels (r = .19, P = .039, n = 116), between constipation and depressive symptoms (r = .18, P = .023, n = 164), and between constipation and pain (r = .23, P = .004, n = 164) in smokers.
PRACTICAL IMPLICATIONS


Health professionals should assess and treat patients with the knowledge that the severity of pain, depression, and constipation may be greater in smokers than in non smokers.",2020,Smokers had similar serotonin levels compared with non smokers.,['smokers and non smokers'],[],"['pain, depressive symptoms, constipation, and serotonin levels', 'serotonin levels', 'constipation and pain', 'constipation and serum serotonin levels', 'constipation and depressive symptoms', 'pain, depressive symptoms, and constipation']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}]",,0.0230196,Smokers had similar serotonin levels compared with non smokers.,"[{'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Inha University, Incheon, Republic of Korea.'}]",Perspectives in psychiatric care,['10.1111/ppc.12503']
580,32195715,Does a Hand Strength-Focused Exercise Program Improve Grip Strength in Older Patients With Wrist Fractures Managed Nonoperatively?: A Randomized Controlled Trial.,"OBJECTIVE


Distal radius fractures in the older population significantly impair grip strength. The aim of the study was to investigate whether a hand strength focused exercise program during the period of immobilization for nonoperatively managed distal radius fractures in this population improved grip strength and quality of life.
DESIGN


This is a single-center randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Fifty-two patients older than 60 yrs who experienced distal radius fractures managed nonoperatively with cast immobilization. The intervention group (n = 26) received a home hand strength-focused exercise program from 2 and 6 wks after injury while immobilized in a full short arm cast. The control group (n = 26) performed finger range of motion exercises as per protocol. Primary outcome was grip strength ratio of injured arm compared with uninjured arm. Secondary outcome included functional scores of the 11-item shortened version of the Disabilities of the Arm, Shoulder and Hand. Outcomes were measured at 2, 6, and 12 wks after injury.
RESULTS


The intervention group significantly improved grip strength ratio at both 6 and 12 wks (6 wks: 40% vs 25%, P = 0.0044, and 12 wks: 81% vs 51%, P = 0.0035). The intervention group improved the 11-item Disabilities of the Arm, Shoulder and Hand score at 12 wks; however, this was not statistically significant (25 vs 40, P = 0.066).
CONCLUSIONS


A hand strength-focused exercise program for elderly patients with distal radius fractures while immobilized significantly improved grip strength.",2020,The intervention group significantly improved grip strength ratio at both 6 and 12 wks,"['Older Patients', 'Fifty-two patients older than 60 yrs who experienced distal radius fractures managed nonoperatively with cast immobilization', 'elderly patients with distal radius fractures']","['home hand strength-focused exercise program from 2 and 6 wks after injury while immobilized in a full short arm cast', 'A hand strength-focused exercise program', 'hand strength focused exercise program', 'Hand Strength-Focused Exercise Program', 'finger range of motion exercises as per protocol']","['grip strength and quality of life', 'functional scores of the 11-item shortened version of the Disabilities of the Arm, Shoulder and Hand', '11-item Disabilities of the Arm, Shoulder and Hand score', 'grip strength ratio of injured arm compared with uninjured arm', 'grip strength ratio', 'grip strength']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0426857', 'cui_str': 'Short arm (finding)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0575830', 'cui_str': 'Joint movement: finger'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",52.0,0.0849428,The intervention group significantly improved grip strength ratio at both 6 and 12 wks,"[{'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'From the Liverpool Hospital, Liverpool, New South Wales, Australia (AN); Concord Hospital, Sydney, New South Wales, Australia (AN, MV, GB, DM, MW, MK, JS); and Royal North Shore Hospital, Sydney, New South Wales, Australia (GB, MK).'}, {'ForeName': 'Mehr', 'Initials': 'M', 'LastName': 'Vather', 'Affiliation': ''}, {'ForeName': 'Gobind', 'Initials': 'G', 'LastName': 'Bal', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Meaney', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Kwa', 'Affiliation': ''}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Sungaran', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001317']
581,32195722,Effect of an Oral Nutrition Supplement Containing Collagen Peptides on Stratum Corneum Hydration and Skin Elasticity in Hospitalized Older Adults: A Multicenter Open-label Randomized Controlled Study.,"OBJECTIVE


The purpose of this randomized open-label study was to investigate the effect of an oral nutrition supplement containing collagen peptides on stratum corneum hydration and skin elasticity.
METHODS


The study protocol was registered at the UMIN Clinical Trials Registry (UMIN 000027347). Once-a-day oral administration of a nutrition supplement containing collagen peptides (10.0 g) was instituted in 39 inpatients 65 years or older who were assigned to either the intervention or the control group using a block-randomization design. Stratum corneum hydration and skin elasticity were measured at baseline and at 2, 4, 6, and 8 weeks after the start of the intervention.
RESULTS


Mean stratum corneum hydration was significantly increased from 43.7 at baseline to 51.7 at postintervention week 8 in the intervention group (P = .001). Differences in skin elasticity from baseline were significant at postintervention week 6 (P = .026) and week 8 (P = .049).
CONCLUSIONS


Oral nutrition supplements containing collagen peptides may reduce skin vulnerability in older adults and thus prevent conditions such as skin tears.",2020,"Differences in skin elasticity from baseline were significant at postintervention week 6 (P = .026) and week 8 (P = .049).
","['39 inpatients 65 years or older', 'older adults', 'Hospitalized Older Adults']","['Oral Nutrition Supplement Containing Collagen Peptides', 'oral nutrition supplement containing collagen peptides', 'nutrition supplement containing collagen peptides']","['Stratum Corneum Hydration and Skin Elasticity', 'skin vulnerability', 'skin elasticity', 'Stratum corneum hydration and skin elasticity', 'Mean stratum corneum hydration']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity (observable entity)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0410416,"Differences in skin elasticity from baseline were significant at postintervention week 6 (P = .026) and week 8 (P = .049).
","[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nomoto', 'Affiliation': 'Tatsuya Nomoto, MD, is Assistant Director of the Hospital, Department of Rehabilitation Medicine, Minamino Hospital, Tokyo, Japan. Shinji Iizaka, PhD, RN, PHN, is Associate Professor, School of Nutrition, College of Nursing and Nutrition, Shukutoku University, Chiba, Japan. Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Acknowledgments: The authors thank the staff at Eisei and Minamino Hospitals for their assistance with skin measurements. Financial support was provided by Nutri Co Ltd, which paid for the test products in addition to lending researchers the measuring equipment. Dr Nomoto discloses that he has received honoraria for lectures from Nutri Co, Ltd. The authors have disclosed no other financial relationships related to this article. Submitted September 4, 2019; accepted in revised form October 11, 2019.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Iizaka', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000655492.40898.55']
582,32029684,"Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations.","BACKGROUND


Administering inactivated influenza vaccine (IIV), 13-valent pneumococcal conjugate vaccine (PCV13), and diphtheria-tetanus-acellular pertussis (DTaP) vaccine together has been associated with increased risk for febrile seizure after vaccination. We assessed the effect of administering IIV at a separate visit from PCV13 and DTaP on postvaccination fever.
METHODS


In 2017-2018, children aged 12 to 16 months were randomly assigned to receive study vaccines simultaneously or sequentially. They had 2 study visits 2 weeks apart; nonstudy vaccines were permitted at visit 1. The simultaneous group received PCV13, DTaP, and quadrivalent IIV (IIV4) at visit 1 and no vaccines at visit 2. The sequential group received PCV13 and DTaP at visit 1 and IIV4 at visit 2. Participants were monitored for fever (≥38°C) and antipyretic use during the 8 days after visits.
RESULTS


There were 110 children randomly assigned to the simultaneous group and 111 children to the sequential group; 90% received ≥1 nonstudy vaccine at visit 1. Similar proportions of children experienced fever on days 1 to 2 after visits 1 and 2 combined (simultaneous [8.1%] versus sequential [9.3%]; adjusted relative risk = 0.87 [95% confidence interval 0.36-2.10]). During days 1 to 2 after visit 1, more children in the simultaneous group received antipyretics (37.4% vs 22.4%;  P  = .020).
CONCLUSIONS


In our study, delaying IIV4 administration by 2 weeks in children receiving DTaP and PCV13 did not reduce fever occurrence after vaccination. Reevaluating this strategy to prevent fever using an IIV4 with a different composition in a future influenza season may be considered.",2020,Similar proportions of children experienced fever on days 1 to 2 after visits 1 and 2 combined (simultaneous [8.1%] versus sequential [9.3%]; adjusted relative risk = 0.87,"['In 2017-2018, children aged 12 to 16 months', '110 children randomly assigned to the simultaneous group and 111 children to the sequential group; 90% received']","['PCV13, DTaP, and quadrivalent IIV (IIV4) at visit 1 and no vaccines at visit 2', 'influenza vaccine (IIV), 13-valent pneumococcal conjugate vaccine (PCV13), and diphtheria-tetanus-acellular pertussis (DTaP) vaccine', '≥1 nonstudy vaccine', 'PCV13 and DTaP', 'Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations']","['fever occurrence', 'Fever', 'antipyretics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}]",110.0,0.15234,Similar proportions of children experienced fever on days 1 to 2 after visits 1 and 2 combined (simultaneous [8.1%] versus sequential [9.3%]; adjusted relative risk = 0.87,"[{'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Department of Pediatrics and walte002@mc.duke.edu.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California; and.'}, {'ForeName': 'A Patricia', 'Initials': 'AP', 'LastName': 'Wodi', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Wes', 'Initials': 'W', 'LastName': 'Rountree', 'Affiliation': 'Duke Human Vaccine Institute, School of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Todd', 'Affiliation': 'Duke Human Vaccine Institute, School of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wiesner', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California; and.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Duffy', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Marquez', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Broder', 'Affiliation': 'Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",Pediatrics,['10.1542/peds.2019-1909']
583,31838450,Cognitive and language performance predicts effects of spelling intervention and tDCS in Primary Progressive Aphasia.,"Predictors of treatment effects allow individual tailoring of treatment characteristics, thereby saving resources and optimizing outcomes. Electrical stimulation coupled with language intervention has shown promising results in improving language performance in individuals with Primary Progressive Aphasia (PPA). The current study aimed to identify language and cognitive variables associated with response to therapy consisting of language intervention combined with transcranial direct current stimulation (tDCS). Forty individuals with PPA received written naming/spelling intervention combined with anodal tDCS or Sham, using a between-subjects, randomized design, with intervention delivered over a period of 3 weeks. Participants were assessed using a battery of neuropsychological tests before and after each phase. We measured letter accuracy during spelling of trained and untrained words, before, immediately after, 2 weeks, and 2 months after therapy. We used step-wise regression methods to identify variables amongst the neuropsychological measures and experimental factors that were significantly associated with therapy outcomes at each time-point. For trained words, improvement was related to pre-therapy scores, in RAVLT (5 trials sum), pseudoword spelling, object naming, digit span backward, spatial span backward and years post symptom onset. Regarding generalization to untrained words, improvement in spelling was associated with pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall. Generalization effects were larger under tDCS compared to Sham at the 2-month post training measurement. We conclude that, for trained words, patients who improve the most are those who retain for longer language skills such as sublexical spelling processes (phoneme-to-grapheme correspondences) and word retrieval, and other cognitive functions such as executive functions and working memory, and those who have a better learning capacity. Generalization to untrained words occurs through improvement in knowledge of phoneme-to-grapheme correspondences. Furthermore, tDCS enhances the generalizability and duration of therapy effects.",2020,"Regarding generalization to untrained words, improvement in spelling was associated with pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall.","['Primary Progressive Aphasia', 'Forty individuals with PPA received', 'individuals with Primary Progressive Aphasia (PPA']","['spelling intervention and tDCS', 'language intervention combined with transcranial direct current stimulation (tDCS', 'written naming/spelling intervention combined with anodal tDCS', 'Electrical stimulation coupled with language intervention']","['generalizability and duration of therapy effects', 'language performance', 'pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall', 'Generalization effects', 'pseudoword spelling, object naming, digit span backward, spatial span backward and years post symptom onset']","[{'cui': 'C0282513', 'cui_str': 'Mesulam Syndrome'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0331515', 'cui_str': 'Triticum spelta'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",40.0,0.0733283,"Regarding generalization to untrained words, improvement in spelling was associated with pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall.","[{'ForeName': 'Vânia', 'Initials': 'V', 'LastName': 'de Aguiar', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Centre for Language and Cognition Groningen (CLCG), University of Groningen. Electronic address: vania.de.aguiar@rug.nl.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health.'}, {'ForeName': 'Bronte N', 'Initials': 'BN', 'LastName': 'Ficek', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Webster', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Department of Otolaryngology, Johns Hopkins Medicine.'}, {'ForeName': 'Adrià', 'Initials': 'A', 'LastName': 'Rofes', 'Affiliation': 'Centre for Language and Cognition Groningen (CLCG), University of Groningen; Global Brain Health Institute, Trinity College Dublin, Dublin, Ireland; Department of Cognitive Science, Johns Hopkins University.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Wendt', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Caffo', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health.'}, {'ForeName': 'Argye E', 'Initials': 'AE', 'LastName': 'Hillis', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Department of Cognitive Science, Johns Hopkins University; Department of Physical Medicine & Rehabilitation, Johns Hopkins University.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Rapp', 'Affiliation': 'Department of Cognitive Science, Johns Hopkins University.'}, {'ForeName': 'Kyrana', 'Initials': 'K', 'LastName': 'Tsapkini', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Department of Cognitive Science, Johns Hopkins University.'}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2019.11.001']
584,32186395,A Prospective Randomized Clinical Trial of Combination Therapy with Proton Pump Inhibitors and Mucolytics in Patients with Laryngopharyngeal Reflux.,"OBJECTIVES


To identify whether combination therapy with mucolytics and proton pump inhibitors (PPIs) leads to faster and more effective symptomatic relief in patients with laryngopharyngeal reflux (LPR).
METHODS


Patients diagnosed as LPR with a reflux symptom index (RSI) ≥ 13 and a reflux finding score (RFS) ≥ 7 were enrolled in this prospective study. Patients were randomly allocated to control (PPI only) or experimental (PPI + mucolytics) groups and changes in RSI and RFS values were assessed at 1- and 3-month follow-up.
RESULTS


One hundred sixteen patients were randomly allocated into either the control group ( n  = 59) or the experimental group ( n  = 57). The RSI and RFS scores significantly decreased in both groups (all  P  < .001) after 1 month of treatment; however, there was no significant difference in RSI change between groups ( P  = .223). After 3 months of treatment, there remained no significant difference in RSI change between groups ( P  = .592).
CONCLUSIONS


Combination therapy with mucolytics and PPI compared to PPI alone did not lead to faster or more effective symptomatic relief in LPR patients.",2020,"The RSI and RFS scores significantly decreased in both groups (all  P  < .001) after 1 month of treatment; however, there was no significant difference in RSI change between groups ( P  = .223).","['patients with laryngopharyngeal reflux (LPR', 'Patients diagnosed as LPR with a reflux symptom index (RSI) ≥ 13 and a reflux finding score (RFS) ≥ 7 were enrolled', 'LPR patients', 'Patients with Laryngopharyngeal Reflux', 'One hundred sixteen patients']","['mucolytics and proton pump inhibitors (PPIs', 'control (PPI only) or experimental (PPI + mucolytics', 'Proton Pump Inhibitors and Mucolytics']","['effective symptomatic relief', 'RSI and RFS values', 'RSI change', 'RSI and RFS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1168250', 'cui_str': 'Laryngopharyngeal Reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0303134', 'cui_str': '7Be radioisotope'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026698', 'cui_str': 'Mucolytics'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",116.0,0.0204404,"The RSI and RFS scores significantly decreased in both groups (all  P  < .001) after 1 month of treatment; however, there was no significant difference in RSI change between groups ( P  = .223).","[{'ForeName': 'Minsuk', 'Initials': 'M', 'LastName': 'Chae', 'Affiliation': 'Department of Otorhinolaryngology, Eulji University School of Medicine, Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Hyuk', 'Initials': 'DH', 'LastName': 'Jang', 'Affiliation': 'Department of Otorhinolaryngology, Eulji University School of Medicine, Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Chan', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology, Eulji University School of Medicine, Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Minsu', 'Initials': 'M', 'LastName': 'Kwon', 'Affiliation': 'Korea University Hospital, Otorhinolaryngology-Head and Neck Surgery, Korea University College of Medicine, Seoul, Republic of Korea.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420913592']
585,30985534,Metabolic Syndrome and the Effectiveness of Low-dose Aspirin on Reproductive Outcomes.,"BACKGROUND


Metabolic syndrome is associated with increases in both inflammation and aspirin resistance, but effectiveness of aspirin in improving reproductive health among women with metabolic syndrome is unknown. We evaluated the effectiveness of low-dose aspirin in improving reproductive outcomes across metabolic syndrome score.
METHODS


The EAGeR trial randomly assigned 1228 women with a history of pregnancy loss to receive 81 mg aspirin or placebo for up to six menstrual cycles of attempting pregnancy and, if they became pregnant, throughout pregnancy. We assessed components of metabolic syndrome at enrollment, including: waist circumference ≥88 cm, triglycerides ≥150 mg/dl, high-density lipoprotein ≤50 mg/dl, blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic, and glucose ≥100 mg/dl. We summed components to calculate metabolic syndrome score.
RESULTS


A total of 229 participants (20%) met full criteria for metabolic syndrome, 207 (18%) had two components, 366 (31%) one component, and 372 (32%) no components. Among those without any component of metabolic syndrome, aspirin was associated with 10.7 [95% confidence interval (CI) = 1.2, 20.2] more pregnancies and 13.7 (95% CI = 3.3, 24.0) more live births per 100 couples. Effects were attenuated as metabolic syndrome score increased and we observed no clear effect of aspirin on pregnancy or live birth among women with metabolic syndrome.
CONCLUSIONS


Low-dose aspirin is most effective in increasing pregnancy and live birth among women with no or few components of metabolic syndrome. Reduced effectiveness among women with metabolic syndrome may be due to differences in effective dose or aspirin resistance.",2019,"Effects were attenuated as metabolic syndrome score increased and we observed no clear effect of aspirin on pregnancy or live birth among women with metabolic syndrome.
","['1228 women with a history of pregnancy loss to receive 81\u2009mg', 'women with no or few components of metabolic syndrome', 'women with metabolic syndrome', '229 participants (20%) met full criteria for metabolic syndrome, 207 (18%) had two components, 366 (31%) one component, and 372 (32%) no components', 'metabolic syndrome at enrollment, including: waist circumference ≥88\u2009cm, triglycerides ≥150\u2009mg/dl, high-density lipoprotein ≤50\u2009mg/dl, blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic, and glucose ≥100\u2009mg/dl']","['Low-dose Aspirin', 'aspirin or placebo', 'low-dose aspirin', 'aspirin']","['metabolic syndrome score', 'pregnancy or live birth', 'Reproductive Outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032967', 'cui_str': 'Pregnancy History'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",1228.0,0.171766,"Effects were attenuated as metabolic syndrome score increased and we observed no clear effect of aspirin on pregnancy or live birth among women with metabolic syndrome.
","[{'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Obstetrics and Gynecology, School of Medicine, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Ashley I', 'Initials': 'AI', 'LastName': 'Naimi', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000001019']
586,32404646,Comparison of Lutetium-177 tin colloid and Rhenium-188 tin colloid radiosynovectomy in chronic knee arthritis.,"OBJECTIVE


To assess the role of Lutetium-177(Lu-177) tin colloid for radiosynovectomy and compare it with Rhenium-188 (Re-188) tin colloid radiosynovectomy for alleviation of pain in patients with chronic inflammatory arthritis of knee.
METHODS


Patients of chronic inflammatory arthritis of the knee underwent pretherapeutic evaluation in a form of knee ultrasonogram, bone scan and clinical evaluation. Fifty-seven recruited patients were allocated at random to receive either intraarticular injections of Lu-177 tin colloid or Re-188 tin colloid. Eventually, 27 patients received Re-188 tin colloid and 30 patients received Lu-177 tin colloid. The joint was then immobilized for 2 days. Response evaluation was done using knee ultrasound, bone scan and clinical findings.
RESULT


Of 30, 20 patients responded to radiosynovectomy in the Lu-177 tin colloid group compared to 21/27 patients in the Re-188 tin colloid group.
CONCLUSION


Lu-177 tin colloid is an effective alternative to Re-188 tin colloid for radiosynovectomy in patients with chronic inflammatory knee arthritis.",2020,"CONCLUSION


Lu-177 tin colloid is an effective alternative to Re-188 tin colloid for radiosynovectomy in patients with chronic inflammatory knee arthritis.","['patients with chronic inflammatory knee arthritis', 'Patients of chronic inflammatory arthritis of the knee underwent pretherapeutic evaluation in a form of knee ultrasonogram, bone scan and clinical evaluation', 'Fifty-seven recruited patients', '27 patients received', 'chronic knee arthritis', 'patients with chronic inflammatory arthritis of knee']","['Rhenium-188 (Re-188) tin colloid radiosynovectomy', 'Lutetium-177 tin colloid and Rhenium-188 tin colloid radiosynovectomy', 'intraarticular injections of Lu-177 tin colloid or Re-188 tin colloid', 'Lu-177 tin colloid', 'Lutetium-177(Lu-177) tin colloid for radiosynovectomy', 'Re-188 tin colloid', 'Re-188 tin colloid group']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0427251', 'cui_str': 'Form of knee'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C1828331', 'cui_str': 'Rhenium-188'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0024170', 'cui_str': 'Lutetium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],57.0,0.046298,"CONCLUSION


Lu-177 tin colloid is an effective alternative to Re-188 tin colloid for radiosynovectomy in patients with chronic inflammatory knee arthritis.","[{'ForeName': 'Shamim Ahmed', 'Initials': 'SA', 'LastName': 'Shamim', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Arora', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Pragati', 'Initials': 'P', 'LastName': 'Jha', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Behera', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Prabhu', 'Affiliation': 'Departments of Nuclear Medicine.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Ansari', 'Affiliation': 'Orthopedics.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Vyas', 'Affiliation': 'Radiodiagnosis, AIIMS, New Delhi, India.'}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Bal', 'Affiliation': 'Departments of Nuclear Medicine.'}]",Nuclear medicine communications,['10.1097/MNM.0000000000001210']
587,32406964,"Prospective cohort study of child mouthing of faeces and fomites in Dhaka, Bangladesh (CHoBI7 Program).","OBJECTIVE


To characterise childhood mouthing and handling behaviours and to assess the association between hand-to-object and object-to-mouth contacts and diarrhoea prevalence in young children in urban Dhaka, Bangladesh.
METHODS


A prospective cohort study was conducted among 494 children under 5 years of age in Dhaka, Bangladesh. This study was nested within the randomised controlled trial of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7) mobile health (mHealth) program. The CHoBI7 mHealth program focuses on promoting handwashing with soap and water treatment to diarrhoea patients and their household members through mobile messages and a single in person visit. Mouthing and handling of faeces and fomites among young children was measured by five-hour structured observation and caregiver reports. Diarrhoea surveillance data was collected monthly for 12 months.
RESULTS


Fifty five percent of caregivers reported that their child put a visibly dirty fomite (object or soil) in their mouth in the past week. Caregivers reported that 50% of children had mouthed visibly dirty objects, 26% had mouthed dirt, and 2% had mouthed faeces. Forty five percent of children were observed mouthing a visibly dirty fomite during structured observation, 40% of children were observed mouthing a visibly dirty object, 10% were observed mouthing soil, and one child (0.2%) was observed mouthing faeces. Mouthing of visibly dirty fomites was highest for children 12-18 months of age with 69% of these children having caregiver reports and 54% having observed events. Children with caregiver reports of mouthing faeces had a significantly higher odds of diarrhoea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
CONCLUSION


These findings demonstrate that mouthing of contaminated fomites among young children is frequent in urban environments in Bangladesh, and that mouthing faeces is associated with a significantly higher odds of diarrhoea. Interventions are urgently needed to protect young children from faecal pathogens in their play spaces.",2020,"Children with caregiver reports of mouthing feces had significantly higher odds of diarrhea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
","['young children in urban Dhaka', 'young children', 'Child Mouthing of Feces and Fomites in Urban Dhaka, Bangladesh (CHoBI7 Program', '494 children under 5 years of age in Dhaka, Bangladesh']",['Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) mobile health (mHealth) program'],"['diarrhea', 'visibly dirty objects', 'diarrhea prevalence', 'visibly dirty fomite (object or soil', 'Diarrhea surveillance data', 'visibly dirty fomite']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1008855', 'cui_str': 'Fomites'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1008855', 'cui_str': 'Fomites'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]",494.0,0.0478912,"Children with caregiver reports of mouthing feces had significantly higher odds of diarrhea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
","[{'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ismat', 'Initials': 'I', 'LastName': 'Minhaj Uddin', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Sultana', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fatema-Tuz', 'Initials': 'FT', 'LastName': 'Johura', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Tasdik', 'Initials': 'MT', 'LastName': 'Hasan', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Ahshanul', 'Initials': 'MA', 'LastName': 'Haque', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon K', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13413']
588,32406965,"Process evaluation for the delivery of a water, sanitation and hygiene mobile health program: findings from the randomised controlled trial of the CHoBI7 mobile health program.","OBJECTIVE


The Cholera-Hospital-Based Intervention for 7-days (CHoBI7) mobile health (mHealth) program delivers mobile messages to diarrhoea patient households promoting water treatment and handwashing with soap. The randomised controlled trial (RCT) of the CHoBI7 mHealth program demonstrated this intervention was effective in significantly reducing diarrhoea and stunting amoung young children. The objective of this study was to assess the implementation of the CHoBI7 mHealth program in delivering mHealth messages during this RCT.
METHODS


517 diarrhoea patient households with 1777 participants received weekly text, voice and interactive voice response (IVR) messages from the CHoBI7 mHealth program over the 12-month program period. The program process evaluation indicators were the following: the percentage of CHoBI7 mHealth messages received and fully listened to by program households (program fidelity and dose), and household members reporting receiving and sharing an mHealth message from the program in the past two weeks (program reach).
RESULTS


Ninety two percent of text messages were received by program households. Eighty three percent of voice and 86% of IVR messages sent were fully listened to by at least one household member. Eighty one percent of IVR quiz responses from households were answered correctly. Program households reported receiving a CHoBI7 mHealth message in the past two weeks at 79% of monthly household visits during the 12-month program. Seventy seven percent of participants reported sharing a program message with a spouse, 55% with a neighbour and 49% with a child during the program period.
CONCLUSION


There was high fidelity, dose and reach of mobile messages delivered for the CHoBI7 mHealth program. This study presents an approach for process evaluation that can be implemented to evaluate future mHealth programs.",2020,83% of voice and 86% of IVR messages sent were fully listened to by at least one household member.,"['young children', 'diarrhea patient households promoting water treatment and handwashing with soap', '517 diarrhea patient households received']","['CHoBI7 mHealth program', 'fully listened to by program households (program fidelity and dose), and beneficiaries reporting receiving and sharing a mHealth message from the program (program reach', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health (mHealth) program', 'weekly text, voice, and interactive voice response (IVR) messages from the CHoBI7 mHealth program']",['diarrhea and stunting'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]",,0.0465095,83% of voice and 86% of IVR messages sent were fully listened to by at least one household member.,"[{'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Hasan', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon', 'Initials': 'S', 'LastName': 'Kumar Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tasdik Hasan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ismat', 'Initials': 'I', 'LastName': 'Minhaj', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Kazi', 'Initials': 'K', 'LastName': 'Md Zillur Rahman', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahamud-Ur', 'Initials': 'MU', 'LastName': 'Rashid', 'Affiliation': 'University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Lubaba', 'Initials': 'L', 'LastName': 'Sharin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Teman', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Alland', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labrique', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13414']
589,30280635,Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer.,"BACKGROUND


Standard first-line therapy for metastatic, squamous non-small-cell lung cancer (NSCLC) is platinum-based chemotherapy or pembrolizumab (for patients with programmed death ligand 1 [PD-L1] expression on ≥50% of tumor cells). More recently, pembrolizumab plus chemotherapy was shown to significantly prolong overall survival among patients with nonsquamous NSCLC.
METHODS


In this double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, 559 patients with untreated metastatic, squamous NSCLC to receive 200 mg of pembrolizumab or saline placebo for up to 35 cycles; all the patients also received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]-paclitaxel for the first 4 cycles. Primary end points were overall survival and progression-free survival.
RESULTS


After a median follow-up of 7.8 months, the median overall survival was 15.9 months (95% confidence interval [CI], 13.2 to not reached) in the pembrolizumab-combination group and 11.3 months (95% CI, 9.5 to 14.8) in the placebo-combination group (hazard ratio for death, 0.64; 95% CI, 0.49 to 0.85; P<0.001). The overall survival benefit was consistent regardless of the level of PD-L1 expression. The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001). Adverse events of grade 3 or higher occurred in 69.8% of the patients in the pembrolizumab-combination group and in 68.2% of the patients in the placebo-combination group. Discontinuation of treatment because of adverse events was more frequent in the pembrolizumab-combination group than in the placebo-combination group (13.3% vs. 6.4%).
CONCLUSIONS


In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel resulted in significantly longer overall survival and progression-free survival than chemotherapy alone. (Funded by Merck Sharp & Dohme; KEYNOTE-407 ClinicalTrials.gov number, NCT02775435 .).",2018,"The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001).","['559 patients with untreated metastatic, squamous NSCLC to receive 200 mg of', 'Squamous Non-Small-Cell Lung Cancer']","['platinum-based chemotherapy or pembrolizumab', 'pembrolizumab or saline placebo', 'carboplatin plus paclitaxel or nab-paclitaxel', 'Pembrolizumab plus Chemotherapy', 'carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]-paclitaxel', 'pembrolizumab plus chemotherapy']","['overall survival and progression-free survival', 'Adverse events of grade 3 or higher', 'median progression-free survival', 'adverse events', 'overall survival benefit', 'median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",559.0,0.754216,"The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001).","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tafreshi', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazières', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Çay Şenler', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fülöp', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lubiniecki', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Dariusz M', 'Initials': 'DM', 'LastName': 'Kowalski', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1810865']
590,32152169,"Actions of annatto-extracted tocotrienol supplementation on obese postmenopausal women: study protocol for a double-blinded, placebo-controlled, randomised trial.","INTRODUCTION


Obesity is a major health concern in postmenopausal women, and chronic low-grade inflammation contributes to the development of obesity. Cellular studies and high-fat-diet-induced obese mouse model mimicking obesity show the antiobesity effect of annatto-extracted tocotrienols (TT) with antioxidant capability. We aim to assess the safety and efficacy of TT consumption for lipid-related parameters in obese postmenopausal women.
METHODS AND ANALYSIS


Eligible obese postmenopausal women will be randomly assigned to placebo group (430 mg olive oil) and TT group (DeltaGold Tocotrienol 70%) for 24 weeks. In the present study, the primary outcome is total/regional fat mass and visceral adipose tissue. The secondary outcomes include lipid profile in serum, mRNA expression of fatty acid synthase and carnitine palmitoyltransferase 1A in fat tissue, oxylipins and endocannabinoids in plasma and adipose tissue, abundance and composition of intestinal microbiome in faeces, high-sensitivity C-reactive protein (hs-CRP) in serum and leptin in serum. Every participant will be evaluated at 0 (prior to starting intervention) and 24 weeks of intervention, except for serum lipid profile and hs-CRP at 0, 12 and 24 weeks. ' Intent-to-treat ' principle is employed for data analysis. Hierarchical linear modelling is used to estimate the effects of dietary TT supplementation while properly accounting for dependency of data and identified covariates. To our knowledge, this is the first randomised, placebo-controlled, double-blinded study to determine dietary TT supplementation on an obese population. If successful, this study will guide the future efficacy TT interventions and TT can be implemented as an alternative for obese population in antiobesity management.
ETHICS AND DISSEMINATION


This study has been approved by the Bioethics Committee of the Texas Tech University Health Sciences Center, Lubbock. An informed consent form will be signed by a participant before enrolling in the study. The results from this trial will be actively disseminated through academic conference presentation and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03705845.",2020,"The secondary outcomes include lipid profile in serum, mRNA expression of fatty acid synthase and carnitine palmitoyltransferase 1A in fat tissue, oxylipins and endocannabinoids in plasma and adipose tissue, abundance and composition of intestinal microbiome in faeces, high-sensitivity C-reactive protein (hs-CRP) in serum and leptin in serum.","['obese population', 'obese population in antiobesity management', 'obese postmenopausal women', 'Eligible obese postmenopausal women']","['dietary TT supplementation', 'TT consumption', 'placebo', 'annatto-extracted tocotrienol supplementation', 'placebo group (430\u2009mg olive oil']","['lipid profile in serum, mRNA expression of fatty acid synthase and carnitine palmitoyltransferase 1A in fat tissue, oxylipins and endocannabinoids in plasma and adipose tissue, abundance and composition of intestinal microbiome in faeces, high-sensitivity C-reactive protein (hs-CRP) in serum and leptin in serum', 'total/regional fat mass and visceral adipose tissue']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0051928', 'cui_str': 'Annatto Extract'}, {'cui': 'C0949647', 'cui_str': 'Tocotrienols'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3658233', 'cui_str': 'Fatty Acid Synthetases'}, {'cui': 'C0007262', 'cui_str': 'Carnitine Acyltransferase I'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoids'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}]",,0.353931,"The secondary outcomes include lipid profile in serum, mRNA expression of fatty acid synthase and carnitine palmitoyltransferase 1A in fat tissue, oxylipins and endocannabinoids in plasma and adipose tissue, abundance and composition of intestinal microbiome in faeces, high-sensitivity C-reactive protein (hs-CRP) in serum and leptin in serum.","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Aryaie', 'Affiliation': 'Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Tinsley', 'Affiliation': 'Kinesiology and Sport Management, Texas Tech University, Lubbock, Texas, USA.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Educational Psychology and Leadership, Texas Tech University, Lubbock, Texas, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Watkins', 'Affiliation': 'Nutrition, University of California Davis, Davis, California, USA.'}, {'ForeName': 'Lane', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'Kinesiology and Sport Management, Texas Tech University, Lubbock, Texas, USA.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alhaj-Saleh', 'Affiliation': 'Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Shankar', 'Affiliation': 'Pediatrics, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Wood', 'Affiliation': 'Clinical Research Institutes, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.'}, {'ForeName': 'Chwan-Li', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': 'Department of Pathology, Texas Tech University Health Sciences Center, Lubbock, Texas, USA leslie.shen@ttuhsc.edu.'}]",BMJ open,['10.1136/bmjopen-2019-034338']
591,32152170,Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial.,"INTRODUCTION


Severe behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal cannabis may be effective in managing SBP in children with developmental disabilities. In particular, cannabidiol (CBD) may be a plausible and safe alternative to current medications. Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP. However there is no evidence from randomised controlled trials to support the use of CBD for SBP. This pilot study aims to investigate the feasibility of conducting a randomised placebo-controlled trial of CBD to improve SBP in children with ID.
METHODS AND ANALYSIS


This is a single-site, double-blind, parallel-group, randomised, placebo-controlled pilot study of 10 participants comparing 98% CBD oil with placebo in reducing SBP in children aged 8-16 years with ID. Eligible participants will be randomised 1:1 to receive either CBD 20 mg/kg/day or placebo for 8 weeks. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires. Safety outcomes and adverse events will be recorded. All data will be reported using descriptive statistics. These data will inform the design of a full scale randomised controlled trial to evaluate the efficacy of CBD in this patient group.
ETHICS AND DISSEMINATION


This protocol has received ethics approval from the Royal Children's Hospital ethics committee (Human Research Ethics Committee no. 38236). Results will be disseminated through peer-reviewed journals, professional networks, conferences and social media.
TRIAL REGISTRATION NUMBER


ACTRN12618001852246.",2020,"Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires.","['children aged 8-16 years with ID', 'Eligible participants', 'children with intellectual disability', 'children with intellectual disability (ID', 'children with developmental disabilities', 'Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP', 'children with ID', '10 participants comparing 98']","['CBD oil with placebo', 'CBD', 'placebo', 'CBD 20\u2009mg/kg/day or placebo']","['severe behavioural problems', 'Safety outcomes and adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.616141,"Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires.","[{'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Efron', 'Affiliation': 'Health Services, Murdoch Childrens Research Institute, Parkville, Victoria, Australia daryl.efron@rch.org.au.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': 'Health Services, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Payne', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Dentistry and Health Science, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Freeman', 'Affiliation': ""The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Cranswick', 'Affiliation': ""The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': 'Health Services, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Chidambaram', 'Initials': 'C', 'LastName': 'Prakash', 'Affiliation': ""The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Epidemiology & Biostatistics, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Health Services, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034362']
592,32152174,Effects of priming intermittent theta burst stimulation on upper limb motor recovery after stroke: study protocol for a proof-of-concept randomised controlled trial.,"INTRODUCTION


Intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), delivered to the ipsilesional primary motor cortex (M1), appears to enhance the brain's response to rehabilitative training in patients with stroke. However, its clinical utility is highly subject to variability in different protocols. New evidence has reported that preceding iTBS, with continuous theta burst stimulation (cTBS) may stabilise and even boost the facilitatory effect of iTBS on the stimulated M1, via metaplasticity. The aim of this study is to investigate the effects of iTBS primed with cTBS (ie, priming iTBS), in addition to robot-assisted training (RAT), on the improvement of the hemiparetic upper limb functions of stroke patients and to explore potential sensorimotor neuroplasticity using electroencephalography (EEG).
METHODS AND ANALYSIS


A three-arm, subjects and assessors-blinded, randomised controlled trial will be performed with patients with chronic stroke. An estimated sample of 36 patients will be needed based on the prior sample size calculation. All participants will be randomly allocated to receive 10 sessions of rTMS with different TBS protocols (cTBS+iTBS, sham cTBS+iTBS and sham cTBS+sham iTBS), three to five sessions per week, for 2-3 weeks. All participants will receive 60 min of RAT after each stimulation session. Primary outcomes will be assessed using Fugl-Meyer Assessment-Upper Extremity scores and Action Research Arm Test. Secondary outcomes will be assessed using kinematic outcomes generated during RAT and EEG.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from The Human Subjects Ethics Sub-committee, University Research Committee of The Hong Kong Polytechnic University (reference number: HSEARS20190718003). The results yielded from this study will be presented at international conferences and sent to a peer-review journal to be considered for publication.
TRIAL REGISTRATION NUMBER


NCT04034069.",2020,"New evidence has reported that preceding iTBS, with continuous theta burst stimulation (cTBS) may stabilise and even boost the facilitatory effect of iTBS on the stimulated M1, via metaplasticity.","['patients with chronic stroke', 'upper limb motor recovery after stroke', 'patients with stroke', '36 patients will be needed based on the prior sample size calculation']","['priming intermittent theta burst stimulation', 'robot-assisted training (RAT', 'electroencephalography (EEG', 'Intermittent theta burst stimulation (iTBS', 'rTMS with different TBS protocols (cTBS+iTBS, sham cTBS+iTBS and sham cTBS+sham\u2009iTBS', 'repetitive transcranial magnetic stimulation (rTMS', 'iTBS primed with cTBS (ie, priming iTBS']","['Fugl-Meyer Assessment-Upper Extremity scores and Action Research Arm Test', 'kinematic outcomes generated during RAT and EEG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]",36.0,0.30469,"New evidence has reported that preceding iTBS, with continuous theta burst stimulation (cTBS) may stabilise and even boost the facilitatory effect of iTBS on the stimulated M1, via metaplasticity.","[{'ForeName': 'Jack Jiaqi', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China 17902718r@connect.polyu.hk.'}, {'ForeName': 'Kenneth N K', 'Initials': 'KNK', 'LastName': 'Fong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}]",BMJ open,['10.1136/bmjopen-2019-035348']
593,32156763,Development and usability testing of HEARTPA♀N: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain.,"INTRODUCTION


More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain.
METHODS AND ANALYSIS


This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3).
ETHICS AND DISSEMINATION


Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars.
TRIAL REGISTRATION NUMBER


NCT03800082.",2020,"We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars.
","['women with cardiac pain', 'Ethics approval was obtained from the University of Toronto (36415; 26 November 2018']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0423636', 'cui_str': 'Cardiac chest pain (finding)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]",[],[],,0.121711,"We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars.
","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Parry', 'Affiliation': 'University of Toronto Lawrence S Bloomberg Faculty of Nursing, Toronto, Ontario, Canada monica.parry@utoronto.ca.'}, {'ForeName': 'Abida', 'Initials': 'A', 'LastName': 'Dhukai', 'Affiliation': 'University of Toronto Lawrence S Bloomberg Faculty of Nursing, Toronto, Ontario, Canada.'}, {'ForeName': 'Hance', 'Initials': 'H', 'LastName': 'Clarke', 'Affiliation': 'Pain Research Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Ann Kristin', 'Initials': 'AK', 'LastName': 'Bjørnnes', 'Affiliation': 'Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Cafazzo', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Cooper', 'Affiliation': 'Patient Advisor, Toronto, Ontario, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Harvey', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Faculty of Health - Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Lalloo', 'Affiliation': 'The Peter Gilgan Centre for Research and Learning, Toronto, Ontario, Canada.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Leegaard', 'Affiliation': 'Institute of Nursing, Oslo Metropolitan University, Oslo, Akershus, Norway.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'Médecine Familiale, Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lovas', 'Affiliation': 'Healthcare Human Factors, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'McFetridge-Durdle', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Norris', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Parente', 'Affiliation': 'Healthcare Human Factors, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Patterson', 'Affiliation': 'Anishnawbe Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Pilote', 'Affiliation': 'Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Pink', 'Affiliation': 'Wasser Pain Management Centre, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Price', 'Affiliation': ""Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'The Peter Gilgan Centre for Research and Learning, Toronto, Ontario, Canada.'}, {'ForeName': 'Akib', 'Initials': 'A', 'LastName': 'Uddin', 'Affiliation': 'Healthcare Human Factors, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'J Charles', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Watt-Watson', 'Affiliation': 'Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Auld', 'Affiliation': 'Patient Advisor, Toronto, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Faubert', 'Affiliation': 'Patient Advisor, Toronto, Ontario, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Patient Advisor, Toronto, Ontario, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Patient Advisor, Toronto, Ontario, Canada.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Rickard', 'Affiliation': 'Patient Advisor, Moose Factory, Ontario, Canada.'}, {'ForeName': 'Vincenza Spiteri', 'Initials': 'VS', 'LastName': 'DeBonis', 'Affiliation': 'Patient Advisor, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-033092']
594,31004340,Extracorporeal Shockwave Therapy Combined with Drug Therapy in Chronic Pelvic Pain Syndrome : A Randomized Clinical Trial.,"PURPOSE


Chronic prostatitis/ chronic pelvic pain syndrome (CP/CPPS) is a nonspecific pelvic pain in the absence of signs of infection or other obvious local pathology for at least three of the last 6 months. Evidence for treatment approach is limited. So the aim of this study is to investigate the effect of extracorporeal shock wave therapy (ESWT) combined with pharmacotherapy in the treatment of CP/CPPS.
MATERIALS AND METHODS


In this randomized clinical  trial, 31 patients with CP/CPPS were investigated in two groups: the intervention group (n=16) was treated with a combination of an alpha-blocker, an anti-inflammatory agent, a muscle relaxant and a short course of antibiotic in combination with 4 sessions of focused ESWT (a protocol of 3000 impulses, 0.25 mJ/mm2  and 3 Hz of frequency). The control group (n=15) received the aforementioned pharmacotherapy with 4 sessions of sham-ESWT . Follow-up was performed 4 and 12 weeks following ESWT by using the Visual Analogue Scale (VAS), International index of Erectile function (IIEF) 5, National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires. Post void residual (PVR) urine and maximum flow rate (Qmax) were also assessed in both groups.
RESULTS


The patients mean age was 43.7 ±12.6 years. In both groups, the mean scores of NIH-CPSI (total and sub-domains) and VAS showed statistically significant improvements after 4 and 12 weeks compared to the baseline (P < .001). In the intervention group, IPSS (mean difference: 4.25) and Qmax (mean difference: 2.22) were also significantly improved (P < .001).  There was a significant improvement in NIH-CPSI (mean difference: 1.1) and VAS scores (mean difference: 1.1) in the intervention group as compared to the control group (P < .01). Qmax, PVR and IIEF score were not statistically different in the two groups.
CONCLUSION


ESWT in combination with pharmacotherapy could improve the treatment outcome in patients with CP/CPPS.",2020,"In the intervention group, IPSS (mean difference: 4.25) and Qmax (mean difference: 2.22) were also significantly improved.","['Chronic prostatitis/ chronic pelvic pain syndrome (CP/CPPS', 'patients with CP/CPPS', 'Chronic Pelvic Pain Syndrome ', 'patients mean age was 43.7 ±12.6 years', '31 patients with CP/CPPS']","['alfa-blocker, an anti-inflammatory agent, a muscle relaxant and a short course of antibiotic in combination with 4 sessions of focused ESWT', 'aforementioned pharmacotherapy with 4 sessions of sham-ESWT ', 'extracorporeal shock wave therapy (ESWT) combined with pharmacotherapy', 'Extracorporeal Shockwave Therapy Combined with Drug Therapy']","['Visual Analogue Scale (VAS), International index of Erectile function (IIEF) 5, National Institutes of Health-Chronic Prostatitis Symptom Index', 'IPSS', 'NIH-CPSI', 'mean scores of NIH-CPSI (total and sub-domains) and VAS', 'VAS scores', 'Qmax, PVR and IIEF score', 'NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires', 'Post void residual (PVR) urine and maximum flow rate (Qmax']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatories'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}]",31.0,0.0426641,"In the intervention group, IPSS (mean difference: 4.25) and Qmax (mean difference: 2.22) were also significantly improved.","[{'ForeName': 'Seyed Mansour', 'Initials': 'SM', 'LastName': 'Rayegani', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. rayegani@gmail.com.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Razzaghi', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Raeissadat', 'Affiliation': 'Clinical Development Research Center of Shahid Modarres Hospital, Physical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Allameh', 'Affiliation': 'Center of Excellence in Training Laser Application in Medicine, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Eliaspour', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Abedi', 'Affiliation': 'Department of Urology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Javadi', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Rahavian', 'Affiliation': 'Department of Urology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4673']
595,32200533,Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia.,"INTRODUCTION


Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation (Lotriga ® , Takeda Pharmaceutical Company Limited), are approved in Japan to treat triglyceridemia. We investigated the effects of omega-3 on vascular endothelial function, measured by flow-mediated dilation (FMD).
METHODS


Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were randomized 1:1 to receive omega-3 at 2 g (QD) or 4 g (2 g BID) for 8 weeks. The primary end point was the change from baseline of fasting  %FMD in each treatment group. Secondary end points included the 4-h postprandial  %FMD and 4-h postprandial triglyceride (TG) level.
RESULTS


Thirty-seven patients were randomized to receive omega-3 at 2 g (n = 18) or 4 g (n = 19). Mean fasting %FMD did not increase from baseline to week 8 in the 2-g group (- 1.2%) or 4-g group (- 1.3%). Mean 4-h postprandial %FMD did not change from baseline to week 8 in the 2-g group (0.0%), but increased in the 4-g group (1.0%). Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001). No new safety concerns were identified.
CONCLUSIONS


Fasting %FMD did not improve after 8 weeks of omega-3 treatment at 2 g or 4 g. After 8 weeks, 4-h postprandial TG levels showed improvement at both doses, with a greater reduction in the 4-g group.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT02824432.",2020,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","['Patients With Hyperlipidemia', 'Thirty-seven patients', 'Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors']","['Omega-3 Fatty Acid Ethyl Esters', 'Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation', 'omega-3 at 2\xa0g']","['Mean 4-h postprandial TG level', '4-h postprandial \xa0%FMD and 4-h postprandial triglyceride (TG) level', 'Vascular Endothelial Function', 'Mean 4-h postprandial %FMD', 'change from baseline of fasting \xa0%FMD', 'Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood', '4-h postprandial TG levels', 'Mean fasting %FMD', 'vascular endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0061511', 'cui_str': 'glutaryl-coenzyme A'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}]",37.0,0.0642346,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","[{'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Teramoto', 'Affiliation': 'Teikyo Academic Research Center, Teikyo University, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suzaki', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan. yuki.suzaki@takeda.com.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Uemura', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01286-1']
596,32202075,Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus.,"OBJECTIVE


This study aimed to evaluate ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus.
METHODS


Data from three placebo-controlled, randomized, Phase 3 studies were pooled. Patients with baseline BMI ≥ 25 (1,377/1,544; 89%) were assessed with a stratification by BMI subgroup.
RESULTS


At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo. For placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively, least squares mean change was 0.1%, -0.8%, and -0.9% for HbA1c and -1.2 kg, -3.1 kg, and -3.2 kg for BW. HbA1c reductions were consistent across BMI subgroups. For ertugliflozin 5 mg and 15 mg, least squares mean change (placebo adjusted) in absolute BW was -1.4 kg and -1.2 kg for BMI 25 to < 30, -1.8 kg and -1.9 kg for BMI 30 to < 35, and -2.5 kg and -2.9 kg for BMI ≥ 35. Percent BW changes were similar across BMI subgroups. Incidence of adverse events was 52.5%, 44.6%, and 50.1% with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively.
CONCLUSIONS


Meaningful reductions in HbA1c, fasting plasma glucose, BW, and SBP were observed with ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus. Ertugliflozin improved HbA1c and SBP and reduced BW across BMI subgroups. Ertugliflozin was generally well tolerated.",2020,"At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo.","['patients with overweight and obesity with\xa0type 2 diabetes mellitus', 'Patients with Overweight and Obesity with Type 2 Diabetes Mellitus', 'Patients with baseline BMI\u2009≥\u200925 ', 'patients with overweight and obesity with type 2 diabetes mellitus']","['ertugliflozin versus placebo', 'Ertugliflozin', 'ertugliflozin', 'placebo, ertugliflozin', 'placebo, ertugliflozin 5 mg, and ertugliflozin']","['HbA1c reductions', 'Efficacy and Safety', 'tolerated', 'Incidence of adverse events', 'HbA1c, fasting plasma glucose, BW, and SBP', 'HbA1c and SBP and reduced BW', 'glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.0537002,"At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo.","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Pfizer Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hakima', 'Initials': 'H', 'LastName': 'Hannachi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, Massachusetts, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22748']
597,32202124,Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial.,"OBJECTIVE


Chronic mechanical neck pain is associated with musculoskeletal tissue alterations. Active trigger points in the trapezius and levator scapulae muscles are common in patients with chronic mechanical neck pain. In this study, we compared the effect of dry needling (DN) combined with manual therapy (MT) to sham dry needling (SDN) combined with MT on pain, pain pressure threshold, cervical range of motion and neck disability in patients with chronic mechanical neck pain.
METHODS


A randomised, single-blind clinical trial was carried out involving 101 participants with chronic mechanical neck pain, divided into an intervention group (DN+MT, n=47) and a control group (SDN+MT, n=54). Participants received two treatment sessions. The intervention group received MT in conjunction with DN of the most mechano-sensitive myofascial trigger point (MTrP). The control group received MT plus SDN. Outcomes measures were: pain intensity (numeric pain rating scale, NPRS), pressure pain threshold (PPT), cervical range of motion (ROM) and neck disability (neck disability index, NDI).
RESULTS


This study found that between-group differences in pain intensity were statistically significant (P<0.01). Pain decreased after the first intervention in the DN+MT group (3.47±0.25 points on the NPRS) and even more so after the second intervention (4.76±0.24 points on the NPRS). After 4 weeks, pain intensity differed from baseline by 4.89±0.27 points on the NPRS. Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group. After the first intervention, a significant increase in PPT within the DN+MT group (3.09±0.8 kg/cm 2 ) was observed. Cervical ROM also showed highly statistically significant differences. After 4 weeks, a statistically significant reduction (P<0.001) in NDI was observed between the two groups.
CONCLUSION


Our results show that DN+MT is efficacious and significantly better than SDN+MT at reducing pain intensity, PPT, neck disability and cervical ROM in patients with chronic mechanical neck pain.
LEVEL OF EVIDENCE


1b.",2020,Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group.,"['patients with chronic mechanical neck pain', '101 participants with chronic mechanical neck pain, divided into an intervention group (DN+MT, n=47) and a control group (SDN+MT, n=54']","['SDN+MT', 'MT in conjunction with DN of the most mechano-sensitive myofascial trigger point (MTrP', 'dry needling', 'DN+MT', 'manual therapy', 'MT plus SDN', 'dry needling (DN) combined with manual therapy (MT) to sham dry needling (SDN) combined with MT']","['pain, pain pressure threshold, cervical range of motion and neck disability', 'pain intensity (numeric pain rating scale, NPRS), pressure pain threshold (PPT), cervical range of motion (ROM) and neck disability (neck disability index, NDI', 'Pain', 'pain intensity, PPT, neck disability and cervical ROM', 'Cervical ROM', 'pain intensity', 'NDI', 'PPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",101.0,0.15229,Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group.,"[{'ForeName': 'Gracia M', 'Initials': 'GM', 'LastName': 'Gallego-Sendarrubias', 'Affiliation': 'Physiotherapy Department, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Martín', 'Affiliation': 'Simplifying Research Institute, Toledo, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1136/acupmed-2018-011682']
598,32184313,Phase II double-blind randomised controlled trial of exogenous administration of melatonin in chronic pain (DREAM-CP): a study protocol.,"INTRODUCTION


Chronic pain is prevalent, and approximately half of patients with chronic pain experience sleep disturbance. Exogenous melatonin is licensed to treat primary insomnia and there is some evidence for analgesic effects of melatonin.The aim of this study is to investigate the effects of oral melatonin (as Circadin) 2 mg at night in adults with severe non-malignant pain of at least 3 months' duration.
METHODS AND ANALYSIS


We will conduct a randomised double-blind placebo-controlled cross-over study. The primary outcome is sleep disturbance. Secondary outcomes are pain intensity, actigraphy, fatigue, reaction time testing, serum melatonin and endogenous opioid peptide levels along with patient views about study participation.We aim to recruit 60 patients with severe chronic pain (average pain intensity ≥7 on the Brief Pain Inventory (BPI)) from a tertiary referral pain clinic in Northeast Scotland. Participants will be randomised to receive melatonin (as modified release Circadin) 2 mg daily for 6 weeks or placebo, followed by a 4-week washout period, then 6 weeks treatment with the treatment they did not receive. Participants will complete the Verran Snyder-Halpern Sleep Scale, Pittsburgh Sleep Quality Index, Pain and Sleep Questionnaire 3-item index, BPI and psychomotor vigilance reaction time testing at 6 points over 20 weeks. Actigraphy watches will be used to provide objective measures of sleep duration and latency and other sleep measures and will prompt patients to report contemporaneous pain and fatigue scores daily.Cross-over analyses will include tests for effects of treatment, period, treatment-period interaction (carryover effect) and sequence. Within-patient effects and longitudinal data will be analysed using mixed linear models, accounting for potential confounders.
ETHICS AND DISSEMINATION


Approved by Office for Research Ethics Committees Northern Ireland, reference 19/NI/0007. Results will be published in peer-reviewed journals and will be presented at national and international conferences.
TRIAL REGISTRATION NUMBER


ISRCTN12861060.",2020,"Secondary outcomes are pain intensity, actigraphy, fatigue, reaction time testing, serum melatonin and endogenous opioid peptide levels along with patient views about study participation.","[""adults with severe non-malignant pain of at least 3 months' duration"", '60 patients with severe chronic pain (average pain intensity ≥7 on the Brief Pain Inventory (BPI)) from a tertiary referral pain clinic in Northeast Scotland', 'chronic pain (DREAM-CP', 'patients with chronic pain experience sleep disturbance']","['Exogenous melatonin', 'exogenous administration of melatonin', 'placebo', 'oral melatonin', 'melatonin']","['sleep disturbance', 'pain intensity, actigraphy, fatigue, reaction time testing, serum melatonin and endogenous opioid peptide levels', 'Chronic pain', 'Verran Snyder-Halpern Sleep Scale, Pittsburgh Sleep Quality Index, Pain and Sleep Questionnaire 3-item index, BPI and psychomotor vigilance reaction time testing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0205753', 'cui_str': 'Opioid Peptide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.652583,"Secondary outcomes are pain intensity, actigraphy, fatigue, reaction time testing, serum melatonin and endogenous opioid peptide levels along with patient views about study participation.","[{'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'Academic Primary Care, Institute of Applied Health Sciences, Aberdeen, UK rosalindadam@abdn.ac.uk.'}, {'ForeName': 'Saravanakumar', 'Initials': 'S', 'LastName': 'Kanakarajan', 'Affiliation': 'Department of Anaesthesia, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Uzunma', 'Initials': 'U', 'LastName': 'Onyeakazi', 'Affiliation': 'The Institute of Medical Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Malachy', 'Initials': 'M', 'LastName': 'Columb', 'Affiliation': 'Wythenshawe Hospital Acute Intensive Care Unit, Manchester University NHS Foundation Trust, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Galley', 'Affiliation': 'The Institute of Medical Sciences, University of Aberdeen, Aberdeen, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034443']
599,32184315,Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial.,"INTRODUCTION


Pain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.
METHODS AND ANALYSIS


This will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.
ETHICS AND DISSEMINATION


This trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.
TRIAL REGISTRATION NUMBER


NCT03632343 ( ClinicalTrials.gov ).",2020,"The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support.","['Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain', '74 adolescents with cancer per arm from nine cancer centres', 'adolescents with cancer and healthcare teams in treating pain', 'adolescents with cancer']","['Pain Squad+ smartphone app to support real-time pain treatment', 'Pain Squad+, with and without nurse support']","['pain interference, HRQL, pain self-efficacy and cost', 'pain intensity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086390', 'cui_str': 'Medical Care Team'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",74.0,0.258904,"The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support.","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Jibb', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada lindsay.jibb@sickkids.ca.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Nathan', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Breakey', 'Affiliation': ""Division of Hematology/Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Johnston', 'Affiliation': ""Division of Hematology/Oncology, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Lewis', 'Affiliation': ""Division of Hematology/Oncology, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McKillop', 'Affiliation': ""Division of Hematology/Oncology, Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Serina', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': ""Division of Hematology/Oncology, London Health Sciences Centre Children's Hospital, London, Ontario, Canada.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sabapathy', 'Affiliation': ""Division of Hematology/Oncology, Montreal Children's Hospital, Montreal, Quebec, Canada.""}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Strahlendorf', 'Affiliation': ""Division of Hematology/Oncology, BC Children's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'J Charles', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Hundert', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Cassiani', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'El-Khechen Richandi', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Insull', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hamilton', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fang', 'Affiliation': 'Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kuczynski', 'Affiliation': 'Ontario Parents Advocating for Children with Cancer, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2020-037251']
600,32164494,Linagliptin in patients with type 2 diabetes and cardiovascular and/or renal disease: results from a cardiovascular and renal outcomes trial.,"Review of: Rosenstock J, Perkovic V, Johansen, OE, et al. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial.  JAMA . 2019;321:69-79. McGuire DK, Alexander JH, Johansen OE, et al. Linagliptin effects on heart failure and related outcomes in individuals with type 2 diabetes mellitus at high cardiovascular and renal risk in CARMELINA.  Circulation . 2019;139:351-361. These two papers describe the findings from the CARMELINA trial (Cardiovascular and Renal Microvascular Outcome Study with Linagliptin): the first paper reported results for the primary cardiovascular composite outcome (cardiovascular [CV] death, nonfatal myocardial infarction [MI], or nonfatal stroke; 3-point major adverse cardiovascular event [3P-MACE]) and the key secondary renal composite outcome (renal death, end-stage kidney disease, or sustained ≥40% decrease in eGFR from baseline); the second paper reported secondary analyses of heart failure (HF) and related outcomes. The CARMELINA trial was a randomized, placebo-controlled, multicenter non-inferiority trial of adults with type 2 diabetes mellitus (T2DM) and elevated CV and renal risk. After a median 2.2-year follow-up of 6979 participants, patients allocated to linagliptin demonstrated no increase in the risk of 3P-MACE versus placebo: hazard ratio (HR) 1.02 [95% confidence interval (CI) 0.89-1.17]; P < 0.001 for non-inferiority. There was also no increase in the risk of hospitalization for HF for linagliptin versus placebo (HR 0.90 [0.74-1.08]). There was no increased risk of progression to end-stage kidney disease or death due to kidney disease (HR 0.87 [0.69-1.10]). Additionally, progression of albuminuria occurred less frequently in patients who received linagliptin versus placebo (HR 0.86 [0.78-0.95]). Overall, no new safety findings were identified for linagliptin, and no increased risk of hypoglycemia was observed for linagliptin versus placebo. Together, these findings from the CARMELINA trial reaffirm treatment guidelines for choosing additional therapies for patients with T2DM at elevated CV and/or renal risk, and provide new information on the role of linagliptin in the management of T2DM.",2020,"Overall, no new safety findings were identified for linagliptin, and no increased risk of hypoglycemia was observed for linagliptin versus placebo.","['patients with T2DM at elevated CV and/or renal risk', 'patients with type 2 diabetes and cardiovascular and/or renal disease', 'individuals with type 2 diabetes mellitus at high cardiovascular and renal risk in CARMELINA', 'adults with type 2 diabetes and high cardiovascular and renal risk', 'adults with type 2 diabetes mellitus (T2DM) and elevated CV and renal risk']","['linagliptin', 'linagliptin vs placebo', 'Linagliptin', 'placebo']","['risk of progression to end-stage kidney disease or death due to kidney disease', 'heart failure', 'progression of albuminuria', 'major cardiovascular events', 'risk of 3P-MACE versus placebo: hazard ratio (HR', 'heart failure (HF) and related outcomes', 'risk of hospitalization for HF', 'primary cardiovascular composite outcome (cardiovascular [CV] death, nonfatal myocardial infarction [MI], or nonfatal stroke; 3-point major adverse cardiovascular event [3P-MACE]) and the key secondary renal composite outcome (renal death, end-stage kidney disease', 'risk of hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",6979.0,0.215336,"Overall, no new safety findings were identified for linagliptin, and no increased risk of hypoglycemia was observed for linagliptin versus placebo.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Guthrie', 'Affiliation': 'The Department of Emergency Medicine, The Ohio State University , Dublin, OH, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1742524']
601,32196636,Relationships Between Profiles of Physical Activity and Major Mobility Disability in the LIFE Study.,"OBJECTIVES


To examine the relationship between time spent in light physical activity (LPA) and in moderate to vigorous physical activity (MVPA) and the pattern of accumulation on the risk for major mobility disability (MMD) in a large multicenter study of physical activity (PA) and aging, the Lifestyle Interventions and Independence for Elders (LIFE) study.
DESIGN


Data were collected from individuals randomized to a PA intervention as part of the LIFE study, an eight-center single-blind randomized clinical trial conducted between February 2010 and December 2013.
SETTING


Lifestyle Interventions and Independence for Elders Study PARTICIPANTS: Older adult participants (78.4 years; N = 507) at risk for MMD.
INTERVENTION


All older adults included in these analyses were randomized to a structured PA intervention that included two center-based plus three to four home-based exercise sessions per week with a primary goal of walking for 150 minutes weekly. Participants attended the intervention for 2.5 years on average.
MEASUREMENTS


MMD was defined as the inability to complete a 400-m walk within 15 minutes and without assistance. Physical function was assessed via the Short Physical Performance Battery (SPPB). Actigraph accelerometers were used to quantify amount and variability in LPA and MVPA.
RESULTS


In an adjusted Cox proportional hazards regression, we identified a significant interaction (P = .017) between SPPB score and LPA amount and variability such that more LPA was associated with a reduced risk for MMD among those with higher initial function, as was lower variability (eg, via distributing LPA across the day). The SPPB × MVPA interaction was significant (P = .04), such that more MVPA was associated with lower MMD risk among those with lower function. Finally, greater MVPA variability was associated with lower risk for MMD.
CONCLUSION


A prescription of PA for older adults should account for key factors such as physical function and emphasize both amount and pattern of accumulation of PA from across the intensity continuum. J Am Geriatr Soc 68:1476-1483, 2020.",2020,"The SPPB × MVPA interaction was significant (P = .04), such that more MVPA was associated with lower MMD risk among those with lower function.","['All older adults', 'Participants attended the intervention for 2.5\u2009years on average', 'older adults', 'Older adult participants (78.4\u2009years; N = 507) at risk for MMD', 'Elders Study PARTICIPANTS', 'Elders (LIFE) study']","['light physical activity (LPA', 'physical activity (PA', 'structured PA intervention that included two center-based plus three to four home-based exercise sessions', 'PA intervention']","['Short Physical Performance Battery (SPPB', 'Physical function', 'Physical Activity and Major Mobility Disability', 'MVPA variability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.0323078,"The SPPB × MVPA interaction was significant (P = .04), such that more MVPA was associated with lower MMD risk among those with lower function.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health and Exercise Sciences, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Sciences, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Shyh-Huei', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistical and Data Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistical and Data Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16386']
602,32196826,Altered fractionation diminishes importance of tumor volume in oropharyngeal cancer: Subgroup analysis of ARTSCAN-trial.,"BACKGROUND


A large tumor volume negatively impacts the outcome of radiation therapy (RT). Altered fractionation (AF) can improve local control (LC) compared with conventional fractionation (CF). The aim of the present study was to investigate if response to AF differs with tumor volume in oropharyngeal cancer.
METHODS


Three hundred and twenty four patients with oropharyngeal cancer treated in a randomized, phase III trial comparing CF (2 Gy/d, 5 d/wk, 7 weeks, total dose 68 Gy) to AF (1.1 Gy + 2 Gy/d, 5 d/wk, 4.5 weeks, total dose 68 Gy) were analyzed.
RESULTS


Tumor volume had less impact on LC for patients treated with AF. There was an interaction between tumor volume and fractionation schedule (P = .039). This differential response was in favor of CF for small tumors and of AF for large tumors.
CONCLUSION


AF diminishes the importance of tumor volume for local tumor control in oropharyngeal cancer.",2020,There was an interaction between tumor volume and fractionation schedule (P = .039).,"['oropharyngeal cancer', 'Three hundred and twenty four patients with oropharyngeal cancer']","['AF (1.1 Gy\u2009', 'radiation therapy (RT', 'Altered fractionation (AF', 'conventional fractionation (CF', 'CF']",[],"[{'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]",[],324.0,0.0619599,There was an interaction between tumor volume and fractionation schedule (P = .039).,"[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Adrian', 'Affiliation': 'Department of Clinical Sciences Lund, Oncology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gebre-Medhin', 'Affiliation': 'Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellén', 'Affiliation': 'Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Elinore', 'Initials': 'E', 'LastName': 'Wieslander', 'Affiliation': 'Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Zackrisson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}]",Head & neck,['10.1002/hed.26142']
603,32194058,"Outcomes of Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in the Early Treatment of Sepsis: The ORANGES Trial.","BACKGROUND


Sepsis is a major public health burden resulting in 25% to 30% in-hospital mortality and accounting for over 20 billion dollars of US hospital costs.
RESEARCH QUESTION


Does hydrocortisone, ascorbic acid, thiamine (HAT) therapy improve clinical outcomes in sepsis and septic shock?
STUDY DESIGN AND METHODS


This was a randomized, double-blinded, placebo-controlled trial conducted from February 2018 to June 2019, assessing an HAT treatment bundle for the management of septic and septic shock patients admitted to an ICU. The primary outcomes were resolution of shock and change in Sequential Organ Failure Assessment (SOFA) score. Secondary outcomes included 28-day mortality, ICU mortality, hospital mortality, procalcitonin clearance (PCT-c), hospital length of stay (LOS), ICU LOS, and ventilator-free days.
RESULTS


One hundred thirty-seven patients were randomized to the treatment group (n = 68) and comparator group (n = 69), respectively, with no significant differences in baseline characteristics. A statistically significant difference was found in the time patients required vasopressors, indicating quicker reversal of shock in the HAT group compared with the comparator group (27 ± 22 vs 53 ± 38 hours, P < .001). No statistically significant change in SOFA score was found between groups 3 (1 - 6) vs 2 (0 - 4), P = .17. No significant differences were found between study arms in ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c.
INTERPRETATION


Our results suggest that the combination of IV ascorbic acid, thiamine, and hydrocortisone significantly reduced the time to resolution of shock. Additional studies are needed to confirm these findings and assess any potential mortality benefit from this treatment.
TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT03422159; URL: www.clinicaltrials.gov.",2020,"There were no significant differences between study arms in ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c.
","['February 2018 to June 2019 assessing an', 'septic and septic shock patients admitted to an intensive care unit (ICU', 'Sepsis', '137 patients']","['intravenous ascorbic acid, thiamine, and hydrocortisone', 'Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids', 'ascorbic acid (AA), thiamine, and hydrocortisone (HAT) treatment bundle', 'placebo']","['resolution of shock and change in Sequential Organ Failure Assessment (SOFA) score', '28-day mortality, ICU mortality, hospital mortality, procalcitonin clearance (PCT-c), hospital length of stay (LOS), ICU LOS, and ventilator free days', 'ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c', 'SOFA score', 'time patients required vasopressors indicating quicker reversal of shock', 'time to resolution of shock']","[{'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",137.0,0.509907,"There were no significant differences between study arms in ICU and hospital mortality, ICU and hospital LOS, ventilator free days, and PCT-c.
","[{'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Iglesias', 'Affiliation': 'Department of Critical Care, Department of Nephrology, Community Medical Center, Toms River, NJ; Department of Nephrology, Jersey Shore University Medical Center, Hackensack Meridian School of Medicine at Seton Hall, Neptune, NJ. Electronic address: jiglesias23@gmail.com.'}, {'ForeName': 'Andrew V', 'Initials': 'AV', 'LastName': 'Vassallo', 'Affiliation': 'Department of Pharmacy, Community Medical Center, Toms River, NJ.'}, {'ForeName': 'Vishal V', 'Initials': 'VV', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, Community Medical Center, Toms River, NJ.'}, {'ForeName': 'Jesse B', 'Initials': 'JB', 'LastName': 'Sullivan', 'Affiliation': 'Fairleigh Dickinson University School of Pharmacy & Health Sciences, Teaneck, NJ.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Pharmacy, Community Medical Center, Toms River, NJ.'}, {'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Elbaga', 'Affiliation': 'Department of Pharmacy, Monmouth Medical Center Southern Campus, Lakewood, NJ.'}]",Chest,['10.1016/j.chest.2020.02.049']
604,32117545,Results of a Standard versus an Accelerated Ponseti Protocol for Clubfoot: A Prospective Randomized Study.,"Background


The aim of this study was to compare the results of the standard once-weekly Ponseti casting technique to an accelerated twice-weekly regimen in our population cohort.
Methods


A prospective randomized controlled study was conducted with a total of 100 consecutive patients (158 feet) being enrolled for the study. Fifty patients were randomized to each group and followed up for at least one year.
Results


Initial mean Pirani score was 4.67 ± 0.73 in the standard group and 4.35 ± 0.76 in the accelerated group, and the score decreased to 0.34 ± 0.38 and 0.35 ± 0.31, respectively. Initial mean Dimeglio score was 11.75 ± 2.75 in the standard group and 10.51 ± 2.57 in the accelerated group, and the score decreased to 0.79 ± 0.77 and 0.79 ± 0.71, respectively, immediately after casting. The average number of casts required to correct all the deformities was 6.3 ± 1.2 in the standard group and 6.1 ± 1.4 in the accelerated group ( p  = 0.45). Average time spent in cast was 58.2 ± 8.3 days in the standard group and 39.5 ± 5.2 days in the accelerated group ( p  < 0.001). Percutaneous Achilles tendon tenotomy was done in 86.42% in the standard group and in 84.41% in the accelerated group ( p  = 0.72). Final results were assessed by using a modified functional rating scoring system: 55.55% clubfeet had excellent results and 44.45% had good results in the standard group, whereas 66.23% clubfeet had excellent results and 33.77% had good results in the accelerated group. None amongst the two groups had fair or poor results.
Conclusions


These results suggest that the accelerated Ponseti technique significantly reduces the correction time without affecting the final results and that it is as safe and effective as the traditional Ponseti technique.",2020,Percutaneous Achilles tendon tenotomy was done in 86.42% in the standard group and in 84.41% in the accelerated group ( p  = 0.72).,"['Clubfoot', '100 consecutive patients (158 feet) being enrolled for the study', 'Fifty patients']",[],"['Initial mean Pirani score', 'average number of casts required to correct all the deformities', 'correction time', 'Initial mean Dimeglio score', 'Average time spent in cast', 'Percutaneous Achilles tendon tenotomy']","[{'cui': 'C0009081', 'cui_str': 'Congenital Talipes Equinovarus'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0001074', 'cui_str': 'Calcaneal Tendon'}, {'cui': 'C0856438', 'cui_str': 'Tenotomy (psoas)'}]",50.0,0.0304511,Percutaneous Achilles tendon tenotomy was done in 86.42% in the standard group and in 84.41% in the accelerated group ( p  = 0.72).,"[{'ForeName': 'Mir Shahidul', 'Initials': 'MS', 'LastName': 'Islam', 'Affiliation': 'Postgraduate Department of Orthopaedics, Government Medical College, Srinagar, India.'}, {'ForeName': 'Qazi Manaan', 'Initials': 'QM', 'LastName': 'Masood', 'Affiliation': 'Postgraduate Department of Orthopaedics, Government Medical College, Srinagar, India.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Bashir', 'Affiliation': 'Postgraduate Department of Orthopaedics, Government Medical College, Srinagar, India.'}, {'ForeName': 'Faisal Y', 'Initials': 'FY', 'LastName': 'Shah', 'Affiliation': 'Postgraduate Department of Orthopaedics, Government Medical College, Srinagar, India.'}, {'ForeName': 'Manzoor A', 'Initials': 'MA', 'LastName': 'Halwai', 'Affiliation': 'Postgraduate Department of Orthopaedics, Government Medical College, Srinagar, India.'}]",Clinics in orthopedic surgery,['10.4055/cios.2020.12.1.100']
605,32188988,"Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


LATITUDE was a randomized, double-blind, international and phase 3 study of abiraterone acetate plus prednisone in patients with high-risk metastatic hormone-naïve prostate cancer. In the first interim analysis of LATITUDE (clinical cutoff date: 31 October 2016), significant prolongation in overall survival and radiographic progression-free survival (co-primary endpoints) was observed when compared with placebo. The results of the Japanese subgroup analysis of LATITUDE first interim analysis were consistent with those of the overall population. In this study, overall survival and safety results from the final analysis of the Japanese subgroup of the LATITUDE study are presented (clinical cutoff date: 15 August 2018).
METHODS


Abiraterone acetate (1000 mg/day) and prednisone (5 mg/day) were administered orally in the abiraterone acetate plus prednisone group, and matching placebos in the placebo group.
RESULTS


Of the 1199 patients included in LATITUDE, 70 constituted the Japanese subgroup (abiraterone acetate plus prednisone: n = 35, placebo: n = 35). Following a median (range) follow-up of 56.6 (2.5, 64.2) months, the median overall survival was not reached in both the treatment arms of the Japanese subgroup (hazard ratio: 0.61; 95% confidence interval: 0.27-1.42; nominal P = 0.2502). A total of 23 deaths (abiraterone acetate plus prednisone: 9 [25.7%], placebo group: 14 [40.0%]) were reported in Japanese subgroup. Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
CONCLUSIONS


In this Japanese subgroup analysis, addition of abiraterone acetate plus prednisone to androgen-deprivation therapy demonstrated favorable efficacy and safety outcomes in patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer. Survival benefits observed in the Japanese subgroup first interim analysis were sustained long-term and were consistent with the overall population.",2020,"Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
","['Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer', 'patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer', 'group: 14 [40.0%]) were reported in Japanese subgroup', 'patients with high-risk metastatic hormone-naïve prostate cancer', '1199 patients included in LATITUDE']","['placebo', 'Abiraterone acetate', 'abiraterone acetate plus prednisone', 'prednisone', 'Japanese subgroup (abiraterone acetate plus prednisone']","['Survival benefits', 'Efficacy and safety', 'overall survival and radiographic progression-free survival', 'overall survival and safety', 'median overall survival', 'Grade 3/4 adverse events', 'efficacy and safety outcomes']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.702251,"Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
","[{'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Toho University Sakura Medical Center, Chiba, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fukasawa', 'Affiliation': 'Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Hashine', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Sumiko', 'Initials': 'S', 'LastName': 'Kitani', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Ohtake', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Shibayama', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Namphuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa030']
606,32185660,Tailored Activation of Middle-Aged Men to Promote Discussion of Recent Active Suicide Thoughts: a Randomized Controlled Trial.,"PURPOSE


Middle-aged men are at high risk of suicide. While about half of those who kill themselves visit a primary care clinician (PCC) shortly before death, in current practice, few spontaneously disclose their thoughts of suicide during the visits, and PCCs seldom inquire about such thoughts. In a randomized controlled trial, we examined the effect of a tailored interactive computer program designed to encourage middle-aged men's discussion of suicide with PCCs.
METHODS


We recruited men 35-74 years old reporting recent (within 4 weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system. In the office before a visit, men viewed the intervention corresponding to their PCC's random group assignment: Men and Providers Preventing Suicide (MAPS) (20 PCCs), providing tailored multimedia promoting discussion of suicide thoughts, or control (22 PCCs), composed of a sleep hygiene video plus brief non-tailored text encouraging discussion of suicide thoughts. Logistic regressions, adjusting for patient nesting within physicians, examined MAPS' effect on patient-reported suicide discussion in the subsequent office visit.
RESULTS


Sixteen of the randomized PCCs had no patients enroll in the trial. From the panels of the remaining 26 PCCs (12 MAPS, 14 control), 48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9 years (SD 11.4). Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]). Logistic regression showed men viewing MAPS were more likely than controls to discuss suicide with their PCC (OR 5.91, 95% CI 1.59-21.94; P = 0.008; nesting-adjusted predicted effect 71% vs. 30%).
CONCLUSIONS


In addressing barriers to discussing suicide, the tailored MAPS program activated middle-aged men with active suicide thoughts to engage with PCCs around this customarily taboo topic.",2020,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"['Middle-Aged Men', 'Men and Providers Preventing Suicide (MAPS) (20 PCCs', ""middle-aged men's discussion of suicide with PCCs"", '48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9\xa0years (SD 11.4', 'Middle-aged men', 'Sixteen of the randomized PCCs', 'We recruited men 35-74\xa0years old reporting recent (within 4\xa0weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system']",['tailored interactive computer program'],['Suicide discussion'],"[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0037585', 'cui_str': 'Computer Programs'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]",,0.0509858,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jerant', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA. afjerant@ucdavis.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, 683 Hoes Lane West, Piscataway, NJ, 08854, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, UCD School of Medicine, 4150 V Street, Suite 2400, PSSB, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stone', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Cipri', 'Affiliation': 'Center for Healthcare Policy and Research, UCD, 2103 Stockton Blvd, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Franks', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05769-3']
607,31074005,"Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.","OBJECTIVE


To assess the efficacy and safety of a remote electrical neuromodulation (REN) device for the acute treatment of migraine.
BACKGROUND


There is a significant unmet need for novel effective well-tolerated acute migraine treatments. REN is a novel acute migraine treatment that stimulates upper arm peripheral nerves to induce conditioned pain modulation - an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. A recent pilot study showed that REN can significantly reduce headache. We have conducted a randomized, double-blind, sham-controlled study to further evaluate the efficacy and safety of REN for the acute treatment of migraine.
METHODS


This was a randomized, double-blind, sham-controlled, multicenter study conducted at 7 sites in the United States and 5 sites in Israel. Two hundred and fifty-two adults meeting the International Classification of Headache Disorders criteria for migraine with 2-8 migraine headaches per month were randomized in a 1:1 ratio to active or sham stimulation. A smartphone-controlled wireless device was applied for 30-45 minutes on the upper arm within 1 hour of attack onset; electrical stimulation was at a perceptible but non-painful intensity level. Migraine pain levels were recorded at baseline, 2, and 48 hours post-treatment. Most bothersome symptoms (MBS) were also recorded. The primary efficacy endpoint was the proportion of participants achieving pain relief at 2 hours post-treatment (improvement from severe or moderate pain to mild or none, or from mild pain to none). Relief of MBS and pain-free at 2 hours were key secondary endpoints.
RESULTS


Active stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]; therapeutic gain of 27.9% [CI 95%  , 15.6-40.2]; P < .0001), pain-free (37.4% vs 18.4%, P = .003), and MBS relief (46.3% vs 22.2%, P = .0008) at 2 hours post-treatment. The pain relief and pain-free superiority of the active treatment was sustained 48 hours post-treatment. The incidence of device-related adverse events was low and similar between treatment groups (4.8% [6/126] vs 2.4% [3/126], P = .499).
CONCLUSIONS


REN provides superior clinically meaningful relief of migraine pain and MBS compared to placebo, offering a safe and effective non-pharmacological alternative for acute migraine treatment.",2019,"RESULTS


Active stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]; therapeutic gain of 27.9% [CI 95%  , 15.6-40.2]; P < .0001), pain-free (37.4% vs 18.4%, P = .003), and MBS relief (46.3% vs 22.2%, P = .0008) at 2 hours post-treatment.","['Two hundred and fifty-two adults meeting the International Classification of Headache Disorders criteria for migraine with 2-8 migraine headaches per month', 'Acute Migraine', 'multicenter study conducted at 7 sites in the United States and 5 sites in Israel']","['remote electrical neuromodulation (REN) device', 'placebo', 'Placebo', 'REN', 'Remote Electrical Neuromodulation (REN']","['therapeutic gain', 'MBS relief', 'pain relief and pain-free superiority', 'proportion of participants achieving pain relief', 'headache', 'incidence of device-related adverse events', 'Most bothersome symptoms (MBS', 'Migraine pain levels', 'Relief of MBS and pain-free', 'efficacy and safety', 'pain-free', 'pain relief']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0393735', 'cui_str': 'Cephalgia Syndromes'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",252.0,0.548449,"RESULTS


Active stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]; therapeutic gain of 27.9% [CI 95%  , 15.6-40.2]; P < .0001), pain-free (37.4% vs 18.4%, P = .003), and MBS relief (46.3% vs 22.2%, P = .0008) at 2 hours post-treatment.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yarnitsky', 'Affiliation': 'Department of Neurology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic College of Medicine, Phoenix, AZ, USA.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Grosberg', 'Affiliation': 'Hartford Healthcare Headache Center, Hartford, CT, USA.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Burstein', 'Affiliation': 'Harvard Medical School and Critical Care and Pain Medicine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Ironi', 'Affiliation': 'Theranica Bio-Electronics LTD., Netanya, Israel.'}, {'ForeName': 'Dagan', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Theranica Bio-Electronics LTD., Netanya, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Theranica Bio-Electronics LTD., Netanya, Israel.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Headache,['10.1111/head.13551']
608,32096571,"Influence of an SGLT2 inhibitor, tofogliflozin, on the resting heart rate in relation to adipose tissue insulin resistance.","AIMS


To examine the effects of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, tofogliflozin, on resting heart rate by exploring baseline factors that independently influenced changes in the resting heart rate.
METHODS


Data on 419 participants in tofogliflozin phase 2/3 trials were analysed. Changes in resting heart rate from baseline to week 24 were analysed using an analysis of covariance (ANCOVA) model with groups (tofogliflozin/placebo) as a fixed effect and baseline values as covariates. The antilipolytic effect was evaluated as adipose tissue insulin resistance (Adipo-IR) and was calculated as the product of fasting insulin and free fatty acid. Multivariate analysis evaluated independent factors for changes in resting heart rate from baseline to week 24.
RESULTS


Of the participants, 58% were men, and mean age, HbA 1c  , BMI and resting heart rate were 57.6 years, 65 mmol/mol (8.1%), 25.5 kg/m 2  and 66 bpm, respectively. At week 24, adjusted mean difference vs. placebo in the change from baseline was -2.3 bpm [95% confidence interval (CI) -4.6, -0.1] with tofogliflozin. Changes in resting heart rate were positively correlated with changes in Adipo-IR, whereas reductions in HbA 1c  , body weight and blood pressure were similar independent of changes in resting heart among quartiles of resting heart rate change. On multivariate analysis, higher baseline resting heart rates and Adipo-IR values were significantly associated with greater reductions in resting heart rate.
CONCLUSIONS


Tofogliflozin corrected resting heart rate levels in accordance with baseline levels. Correction of high resting heart rates may be attributed to improved adipose tissue insulin resistance, leading to correction of hyperinsulinaemia.",2020,"At week 24, adjusted mean difference vs. placebo in the change from baseline was -2.3 bpm [95% confidence interval (CI) -4.6, -0.1] with tofogliflozin.","[' 58% were men, and mean age, HbA 1c  , BMI and resting heart rate were 57.6 years, 65 mmol/mol (8.1%), 25.5 kg/m 2  and 66 bpm, respectively', 'Data on 419 participants in tofogliflozin phase 2/3 trials were analysed']","['Tofogliflozin', 'tofogliflozin/placebo', 'placebo', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor, tofogliflozin', 'SGLT2 inhibitor, tofogliflozin']","['antilipolytic effect', 'HbA 1c  , body weight and blood pressure', 'resting heart rate', 'adipose tissue insulin resistance (Adipo-IR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C3501434'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C3501434'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",419.0,0.0414319,"At week 24, adjusted mean difference vs. placebo in the change from baseline was -2.3 bpm [95% confidence interval (CI) -4.6, -0.1] with tofogliflozin.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nojima', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Clinical Data Science Department, Kowa Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14279']
609,31420647,Effect of Monthly High-Dose Vitamin D Supplementation on Acute Respiratory Infections in Older Adults: A Randomized Controlled Trial.,"BACKGROUND


Although adults with low vitamin D status are at increased risk of acute respiratory infection (ARI), randomized controlled trials of vitamin D supplementation have provided inconsistent results.
METHODS


We performed a randomized, double-blinded, placebo-controlled trial of 5110 adults aged 50-84 years. In 2011-2012, participants were randomized to an initial oral dose of 200 000 IU vitamin D3 followed by 100 000 IU monthly (n = 2558) or placebo (n = 2552) until late 2013 (median follow-up, 1.6 years). Participants reported upper and lower ARIs on monthly questionnaires. Cox models analyzed time to first ARI (upper or lower) by treatment group.
RESULTS


Participants' mean age was 66 years and 58% were male; 83% were of European/other ethnicity, with the rest Maori, Polynesian, or South Asian. Mean (SD) baseline blood 25-hydroxyvitamin D [25(OH)D] level was 63 (24) nmol/L; 25% were <50 nmol/L. In a random sample (n = 441), vitamin D supplementation increased mean 25(OH)D to 135 nmol/L at 3 years, while those on placebo remained at 63 nmol/L. During follow-up, 3737 participants reported ≥1 ARI: 74.1% in the vitamin D group versus 73.7% in the placebo group. The hazard ratio for vitamin D compared with placebo was 1.01 (95% CI, 0.94, 1.07). Similar results were seen in most subgroups, including those with baseline 25(OH)D <50 nmol/L and in analyses of the upper/lower components of the ARI outcome.
CONCLUSIONS


Monthly high-dose vitamin D supplementation does not prevent ARI in older adults with a low prevalence of profound vitamin D deficiency at baseline. Whether effects of daily or weekly dosing differ requires further study.
CLINICAL TRIALS REGISTRATION


Australian New Zealand Clinical Trials Registry, identifier ACTRN12611000402943.",2020,"The hazard ratio for vitamin D compared to placebo was 1.01 (95%CI, 0.94, 1.07).","['adults with low vitamin D status', 'older adults', ""Participants' mean age was 66 years and 58% were male; 83% were of European/Other ethnicity, with the rest Maori, Polynesian or South Asian"", '5,110 adults, aged 50-84 years', 'older adults with a low prevalence of profound vitamin D deficiency at baseline']","['vitamin D supplementation', 'vitamin D', 'placebo', 'vitamin D3 followed by 100,000 IU monthly (n=2,558) or placebo']","['hazard ratio for vitamin D', 'acute respiratory infections', 'Mean (SD) baseline blood', '25-hydroxyvitamin D (25OHD) level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0024770', 'cui_str': 'Maori (ethnic group)'}, {'cui': 'C0240790', 'cui_str': 'Polynesians (ethnic group)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3737.0,0.800118,"The hazard ratio for vitamin D compared to placebo was 1.01 (95%CI, 0.94, 1.07).","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Alistair W', 'Initials': 'AW', 'LastName': 'Stewart', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, United Kingdom.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of General Practice, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz801']
610,32200512,Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials.,"INTRODUCTION


Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of moderate-to-severe plaque psoriasis. Our objective was to evaluate the long-term efficacy and safety of ixekizumab in moderate-to-severe plaque psoriasis through 5 years.
METHODS


Data were integrated from the UNCOVER-1 and UNCOVER-2, randomized, double-blinded, phase-3 trials. Patients who continuously received the labeled ixekizumab dose, were static Physician's Global Assessment (sPGA) (0,1) responders at Week 12 and completed 60 weeks of treatment could enter the long-term extension (LTE) period. Patients could escalate to every-2-week dosing per investigator opinion. Efficacy and health outcomes included proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI ≤ 5/ ≤ 3/ ≤ 2/ ≤ 1 and Dermatology Life Quality Index (DLQI) (0,1). Results exclude patients who escalated to every-2-week dosing. A modified non-responder imputation method was used to account for missing data. Supplemental analyses include patients who escalated to every-2-week dosing and observed and multiple imputation results. Exposure-adjusted safety outcomes are also reported.
RESULTS


Of 206 patients who entered the LTE periods, 172 completed treatment. At Week 60, PASI 75/90/100 responses were 94.7%, 85.0% and 62.1%, respectively, and at year 5 were 90.3%, 71.3% and 46.3%, respectively. Similarly, meaningful responses were achieved for the other efficacy and health measures. Among patients with PASI 100 through 5 years, 92% achieved DLQI (0,1), indicating no impact of skin disease on quality of life. During the LTE period, exposure-adjusted incidence rates were 31.4 per 100 patient-years for treatment-emergent adverse events and 6.8 per 100 patient-years for serious adverse events. No deaths were reported. No new or unexpected safety findings were noted.
CONCLUSIONS


The results demonstrate 80 mg ixekizumab maintains long-term efficacy and a safety profile consistent with previous data in patients with moderate-to-severe plaque psoriasis through 5 years of treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, UNCOVER-1: NCT01474512, UNCOVER-2: NCT01597245.",2020,"No new or unexpected safety findings were noted.
","['206 patients who entered the LTE periods, 172 completed treatment', 'moderate-to-severe plaque psoriasis through 5\xa0years', 'patients with moderate-to-severe plaque psoriasis through 5\xa0years of treatment', 'Through 5 Years in Moderate-to-Severe Psoriasis']","['ixekizumab', 'Ixekizumab', ""labeled ixekizumab dose, were static Physician's Global Assessment (sPGA""]","['exposure-adjusted incidence rates', 'Efficacy and Safety', 'PASI 75/90/100 responses', 'quality of life', 'proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI\u2009≤\u20095', 'Dermatology Life Quality Index (DLQI) (0,1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",206.0,0.0947104,"No new or unexpected safety findings were noted.
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, St. Louis, MO, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Torii', 'Affiliation': 'Division of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Guenther', 'Affiliation': 'Guenther Dermatology Research Centre, London, ON, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SkiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Ferris', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'ElMaraghy', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Crane', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shrom', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA. shrom_david_stanley@lilly.com.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Leung', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada.'}]",Dermatology and therapy,['10.1007/s13555-020-00367-x']
611,32068442,"Responses of gut and pancreatic hormones, bile acids, and fibroblast growth factor-21 differ to glucose, protein, and fat ingestion after gastric bypass surgery.","Postprandial gut hormone responses change after Roux-en-Y gastric bypass (RYGB), and we investigated the impact of glucose, protein, and fat (with and without pancreas lipase inhibition) on plasma responses of gut and pancreas hormones, bile acids, and fibroblast growth factor 21 (FGF-21) after RYGB and in nonoperated control subjects. In a randomized, crossover study 10 RYGB operated and 8 healthy weight-matched control subjects were administered 4 different 4-h isocaloric (200 kcal) liquid meal tests containing >90 energy (E)% of either glucose, protein (whey protein), or fat (butter with and without orlistat). The primary outcome was glucagon-like peptide-1 (GLP-1) secretion (area under the curve above baseline). Secondary outcomes included responses of peptide YY (PYY), glucose-dependent insulinotropic polypeptide (GIP), cholecystokinin (CCK), glicentin, neurotensin, ghrelin, insulin, glucagon, bile acids, and FGF-21. In the RYGB group the responses of GLP-1, GIP, glicentin, FGF-21, and C-peptide were increased after glucose compared with the other meals. The neurotensin and bile acids responses were greater after fat, while the glucagon and CCK responses were greater after protein ingestion. Furthermore, compared with control subjects, RYGB subjects had greater responses of total PYY after glucose, glucagon after glucose and fat, glicentin after glucose and protein, and GLP-1 and neurotensin after all meals, while GIP and CCK responses were lower after fat. Ghrelin responses did not differ between meals or between groups. Orlistat reduced all hormone responses to fat ingestion, except for ghrelin in the RYGB group. In conclusion, after RYGB glucose is a more potent stimulator of most gut hormones, especially for the marked increased secretion of GLP-1 compared with fat and protein. NEW & NOTEWORTHY  We investigated the impact of glucose, protein, and fat meals on intestinal and pancreatic hormones, bile acid, and fibroblast growth factor 21 (FGF-21) secretion in gastric bypass-operated patients compared with matched nonoperated individuals. The fat meal was administered with and without a pancreas lipase inhibitor. We found that the impact of the different meals on gut hormones, bile, and FGF 21 secretion differ and was different from the responses observed in nonoperated control subjects.",2020,"The neurotensin and bile acids responses were greater after fat, while the glucagon and CCK responses were greater after protein ingestion.",['eight healthy weight-matched control subjects'],"['glucose, protein and fat (with and without pancreas lipase inhibition', 'Orlistat®', '4-hour isocaloric (200 kcal) liquid meal-tests containing >90E% of either glucose, protein (whey protein) or fat (butter with and without orlistat®', 'Roux-en-Y gastric bypass (RYGB']","['responses of total PYY after glucose, glucagon after glucose and fat, glicentin after glucose and protein, and GLP-1 and neurotensin after all meals, while GIP and CCK responses', 'responses of GLP-1, GIP, glicentin, FGF-21 and C-peptide', 'Responses of gut and pancreatic hormones, bile acids and fibroblast growth', 'glucagon and CCK responses', 'plasma responses of gut and pancreas hormones, bile acids and FGF-21', 'neurotensin and bile acids responses', 'responses of PYY, GIP, CCK, glicentin, neurotensin, insulin, glucagon, bile acids and FGF 21', 'GLP-1 secretion (area under the curve above baseline']","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0076275', 'cui_str': 'orlistat'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0061309', 'cui_str': 'Glicentine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0027930', 'cui_str': 'Neurotensin'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1505513', 'cui_str': 'CCK(58)(ns)'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0016030', 'cui_str': 'Fibroblasts'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0005388', 'cui_str': 'Bile'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.0143719,"The neurotensin and bile acids responses were greater after fat, while the glucagon and CCK responses were greater after protein ingestion.","[{'ForeName': 'Christian Zinck', 'Initials': 'CZ', 'LastName': 'Jensen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Kirstine N', 'Initials': 'KN', 'LastName': 'Bojsen-Møller', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Svane', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Line M', 'Initials': 'LM', 'LastName': 'Holst', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai Jacob', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rune Ehrenreich', 'Initials': 'RE', 'LastName': 'Kuhre', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Viggo B', 'Initials': 'VB', 'LastName': 'Kristiansen', 'Affiliation': 'Department of surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jens Frederik', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Trine R', 'Initials': 'TR', 'LastName': 'Clausen', 'Affiliation': 'Department of Diabetes and Obesity Biology, Novo Nordisk A/S, Maaloev, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}]",American journal of physiology. Gastrointestinal and liver physiology,['10.1152/ajpgi.00265.2019']
612,32184305,"Phase I trial of WEE1 inhibition with chemotherapy and radiotherapy as adjuvant treatment, and a window of opportunity trial with cisplatin in patients with head and neck cancer: the  WISTERIA  trial protocol.","INTRODUCTION


Patients with head and neck squamous cell carcinoma with locally advanced disease often require multimodality treatment with surgery, radiotherapy and/or chemotherapy. Adjuvant radiotherapy with concurrent chemotherapy is offered to patients with high-risk pathological features postsurgery. While cure rates are improved, overall survival remains suboptimal and treatment has a significant negative impact on quality of life.Cell cycle checkpoint kinase inhibition is a promising method to selectively potentiate the therapeutic effects of chemoradiation. Our hypothesis is that combining chemoradiation with a WEE1 inhibitor will affect the biological response to DNA damage caused by cisplatin and radiation, thereby enhancing clinical outcomes, without increased toxicity. This trial explores the associated effect of WEE1 kinase inhibitor adavosertib (AZD1775).
METHODS AND ANALYSIS


This phase I dose-finding, open-label, multicentre trial aims to determine the highest safe dose of AZD1775 in combination with cisplatin chemotherapy preoperatively (group A) as a window of opportunity trial, and in combination with postoperative cisplatin-based chemoradiation (group B).Modified time-to-event continual reassessment method will determine the recommended dose, recruiting up to 21 patients per group. Primary outcomes are recommended doses with predefined target dose-limiting toxicity probabilities of 25% monitored up to 42 days (group A), and 30% monitored up to 12 weeks (group B). Secondary outcomes are disease-free survival times (groups A and B). Exploratory objectives are evaluation of pharmacodynamic (PD) effects, identification and correlation of potential biomarkers with PD markers of DNA damage, determine rate of resection status and surgical complications for group A; and quality of life in group B.
ETHICS AND DISSEMINATION


Research Ethics Committee, Edgbaston, West Midlands (REC reference 16/WM/0501) initial approval received on 18/01/2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


ISRCTN76291951 and NCT03028766.",2020,Secondary outcomes are disease-free survival times (groups A and B).,"['patients with head and neck cancer', 'patients with high-risk pathological features postsurgery', 'Patients with head and neck squamous cell carcinoma with locally advanced disease often require']","['WEE1 kinase inhibitor adavosertib (AZD1775', 'AZD1775', 'postoperative cisplatin-based chemoradiation', 'multimodality treatment with surgery, radiotherapy and/or chemotherapy', 'Adjuvant radiotherapy with concurrent chemotherapy', 'chemotherapy and radiotherapy', 'cisplatin', 'cisplatin chemotherapy']","['overall survival', 'quality of life', 'toxicity', 'doses with predefined target dose-limiting toxicity probabilities', 'disease-free survival times']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4053677', 'cui_str': 'AZD1775'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.137362,Secondary outcomes are disease-free survival times (groups A and B).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Kong', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Good', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kirkham', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Savage', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Mant', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Llewellyn', 'Affiliation': 'SIMBEC Research Limited, Merthyr Tydfil, Glamorgan, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Parish', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Spruce', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Forster', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Schipani', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, Glasgow, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sacco', 'Affiliation': 'Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Murray', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yap', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Mehanna', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK h.mehanna@bham.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033009']
613,32169925,Assessing the effect of closed-loop insulin delivery from onset of type 1 diabetes in youth on residual beta-cell function compared to standard insulin therapy (CLOuD study): a randomised parallel study protocol.,"INTRODUCTION


Management of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy.
METHODS AND ANALYSIS


The study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10-16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9-10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (<3.9 mmol/L) at 12 months. Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight. Cognitive, emotional and behavioural characteristics of participants and parents will be evaluated, and a cost-utility analysis performed to support adoption of CL as a standard treatment modality following diagnosis of T1D.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from Cambridge East Research Ethics Committee. The results will be disseminated by peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT02871089; Pre-results.",2020,"Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight.","['96 participants aged 10-16.9 years, recruited within 21 days of diagnosis with T1D. Following a']","['closed-loop insulin delivery', 'conventional MDI therapy or with CL insulin delivery', 'hybrid closed-loop (CL) insulin delivery', 'standard insulin therapy', 'baseline mixed meal tolerance test (MMTT']","['glycated haemoglobin (HbA1c) and time spent in hypoglycaemia', 'area under the stimulated C-peptide curve (AUC', 'Cognitive, emotional and behavioural characteristics', 'time spent in target glucose range', 'stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",96.0,0.230446,"Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Allen', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tauschmann', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Musolino', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Professor David', 'Initials': 'PD', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': ""Children's Diabetes Centre, Leeds Children's Hospital, Leeds, UK.""}, {'ForeName': 'Atrayee', 'Initials': 'A', 'LastName': 'Ghatak', 'Affiliation': ""Department of Diabetes, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Randell', 'Affiliation': ""Department of Paediatric Diabetes and Endocrinology, Nottingham Children's Hospital, Nottingham, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Besser', 'Affiliation': 'NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Trevelyan', 'Affiliation': ""Paediatric Diabetes, Southampton Children's Hospital, Southampton, UK.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Elleri', 'Affiliation': 'Department of Diabetes, Royal Hospital for Sick Children, Edinburgh, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Northam', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Endocrinology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Scott', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lawton', 'Affiliation': 'The University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Roze', 'Affiliation': 'HEVA HEOR Sarl, Lyon, France.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sibayan', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Todd', 'Affiliation': 'Wellcome Trust Centre for Human Genetics, Oxford, UK.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK rh347@cam.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033500']
614,32179560,Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing.,"INTRODUCTION


Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.
METHODS AND ANALYSIS


The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0-12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study's coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.
ETHICS AND DISSEMINATION


The study protocol was approved by the institutional review board (IRB) at Children's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.
TRIAL REGISTRATION NUMBER


NCT02562040; Pre-results.",2020,Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime).,"[""Children's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 11 214"", 'Pediatric Adenotonsillectomy Trial for Snoring (PATS', 'Four hundred sixty eligible children, aged 3.0-12.9 years old', 'mild obstructive sleep-disordered breathing']","['early adenotonsillectomy or to watchful waiting with supportive care (WWSC', 'Mild obstructive sleep-disordered breathing (oSDB', 'adenotonsillectomy']","['executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF', 'Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter', 'BRIEF GEC score and GNG score']","[{'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection Analysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",460.0,0.222773,Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime).,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA rwang@hsph.harvard.edu.'}, {'ForeName': 'Jessie P', 'Initials': 'JP', 'LastName': 'Bakker', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Chervin', 'Affiliation': 'Sleep Disorders Center and Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Garetz', 'Affiliation': 'Sleep Disorders Center and Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Fauziya', 'Initials': 'F', 'LastName': 'Hassan', 'Affiliation': 'Sleep Disorders Center and Division of Pediatric Pulmonology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Ishman', 'Affiliation': ""Divisions of Otolaryngology-Head and Neck Surgery and Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Ron B', 'Initials': 'RB', 'LastName': 'Mitchell', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, UT Southwestern and Children's Medical Center Dallas, Dallas, Texas, USA.""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Morrical', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Syed K', 'Initials': 'SK', 'LastName': 'Naqvi', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, UT Southwestern and Children's Medical Center Dallas, Dallas, Texas, USA.""}, {'ForeName': 'Jerilynn', 'Initials': 'J', 'LastName': 'Radcliffe', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Emily I', 'Initials': 'EI', 'LastName': 'Riggan', 'Affiliation': 'Department of Otolaryngology, Eastern Virginia Medical School, Norfolk, Virginia, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Rosen', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rueschman', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Ignacio E', 'Initials': 'IE', 'LastName': 'Tapia', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'H Gerry', 'Initials': 'HG', 'LastName': 'Taylor', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Zopf', 'Affiliation': 'Sleep Disorders Center and Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",BMJ open,['10.1136/bmjopen-2019-033889']
615,30316719,Type of Blunt Expansion of the Low Transverse Uterine Incision During Caesarean Section and the Risk of Postoperative Complications: A Prospective Randomized Controlled Trial.,"OBJECTIVE


To evaluate two techniques of uterine incision expansion (cephalad-caudad vs. transverse) during Caesarean section (CS).
METHODS


A total of 839 patients were randomized to either a cephalad-caudad blunt expansion of uterine incision during CS versus a transverse (lateral-lateral) expansion. The primary outcome was blood loss, measured with the descent of hemoglobin level. Secondary outcomes were the need for blood transfusion and the number of surgical or postoperative complications presented in both groups.
RESULTS


There was no statistical difference with regard to decrease in hemoglobin level, but there was a higher number of surgical complications in the transverse expansion group (Cephalad-caudad: 11.53% vs. transverse: 16.42%; odds ratio [OR] 0.66; 95% confidence interval [CI] 0.45-0.98; P = 0.04). There were more cases of unintended extensions of uterine incision (10.35% vs. 16.18%; OR 0.6; 95% CI 0.4-0.9; P = 0.01) but no statistical difference in the number of hematomas, uterine vessel injury, or the need to transfuse.
CONCLUSION


The cephalad-caudad blunt expansion technique of the low transverse uterine incision is safer than the transverse expansion. There was no difference in regard to decrease in hemoglobin level, but there is a lower risk of surgical complications not associated with an increased need for blood transfusions when compared with the transverse expansion.",2019,"There was no statistical difference with regard to decrease in hemoglobin level, but there was a higher number of surgical complications in the transverse expansion group (Cephalad-caudad: 11.53% vs. transverse: 16.42%; odds ratio [OR] 0.66; 95% confidence interval [CI] 0.45-0.98; P = 0.04).",['839 patients'],"['cephalad-caudad blunt expansion of uterine incision during CS versus a transverse (lateral-lateral) expansion', 'Low Transverse Uterine Incision', 'low transverse uterine incision', 'uterine incision expansion (cephalad-caudad vs. transverse) during Caesarean section (CS']","['Risk of Postoperative Complications', 'unintended extensions of uterine incision', 'need for blood transfusion and the number of surgical or postoperative complications', 'surgical complications', 'blood transfusions', 'blood loss, measured with the descent of hemoglobin level', 'number of hematomas, uterine vessel injury, or the need to transfuse', 'hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",839.0,0.204897,"There was no statistical difference with regard to decrease in hemoglobin level, but there was a higher number of surgical complications in the transverse expansion group (Cephalad-caudad: 11.53% vs. transverse: 16.42%; odds ratio [OR] 0.66; 95% confidence interval [CI] 0.45-0.98; P = 0.04).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Morales', 'Affiliation': 'Maternidad del Hospital Santo Tomás, Panama, Panama.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Reyes', 'Affiliation': 'Maternidad del Hospital Santo Tomás, Panama, Panama. Electronic address: oreyespanama@yahoo.es.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Cárdenas', 'Affiliation': 'Maternidad del Hospital Santo Tomás, Panama, Panama.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.04.004']
616,32193820,Effect of diode laser application as an adjunct to nonsurgical periodontal therapy on the reduction of red complex microorganisms in type 2 diabetics with chronic periodontitis.,"Bactericidal and detoxification effects of diode laser (DL) have been reported in periodontal treatment. The objective of this study was investigating the additional effect of DL with nonsurgical periodontal treatment on the red complex bacteria in type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP). Sixty type 2 DM patients with chronic periodontitis (CP) were randomly assigned in two parallel groups to receive scaling root planning (SRP, n = 30) or SRP followed by DL periodontal pocket irradiation (SRP + DL, n = 30). Recording of clinical parameters and subgingival plaque sampling were performed at baseline, and post therapy (1 and 3 months after treatment). Amounts of Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia were evaluated with quantitative RT-PCR. Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points. No additional benefit of DL as an adjunct to nonsurgical periodontal therapy was recognized in the reduction of P. gingivalis, T. denticola, and T. forsythia for type 2 DM patients with CP. Further studies are required to clarify the effects of diode laser on the other periodontopathogens.",2020,"Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points.","['Sixty type 2 DM patients with chronic periodontitis (CP', 'type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP', 'type 2 diabetics with chronic periodontitis']","['diode laser application', 'diode laser (DL', 'DL', 'scaling root planning (SRP, n\u2009=\u200930) or SRP followed by DL periodontal pocket irradiation (SRP + DL, n\u2009=\u200930', 'diode laser']","['bacterial reductions', 'Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia', 'red complex microorganisms']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0031094', 'cui_str': 'Periodontal Pocket'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0314961', 'cui_str': 'Bacteroides forsythus'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}]",60.0,0.0363979,"Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points.","[{'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Kocak', 'Affiliation': 'Izzet Baysal Mouth and Dental Health Center, Bolu, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sağlam', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey. dtmehmetsaglam@gmail.com.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Arslan', 'Affiliation': 'Department of Microbiology, School of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Seyit Ali', 'Initials': 'SA', 'LastName': 'Kayis', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Karabük University, Karabuk, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kebapcilar', 'Affiliation': 'Department of Endocrinology and Metabolism Disease, School of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Loos', 'Affiliation': 'Department of Periodontology, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sema S', 'Initials': 'SS', 'LastName': 'Hakki', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Selcuk University, Konya, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-02997-1']
617,32090517,Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial.,"OBJECTIVE


Previous studies have shown additive weight loss when intensive behavioral therapy (IBT) was combined with weight-loss medication. The present multisite study provides the first evaluation, in primary care, of the effect of the Centers for Medicare and Medicaid Services-based IBT benefit, delivered alone (with placebo) or in combination with liraglutide 3.0 mg.
METHODS


The Satiety and Clinical Adiposity-Liraglutide Evidence in individuals with and without diabetes (SCALE) IBT was a 56-week, randomized, double-blind, placebo-controlled, multicenter trial in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140) as an adjunct to IBT.
RESULTS


At week 56, mean weight loss with liraglutide 3.0 mg plus IBT was 7.5% and 4.0% with placebo combined with IBT (estimated treatment difference [95% CI]-3.4% [-5.3% to -1.6%], P = 0.0003). Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311). Liraglutide 3.0 mg in combination with IBT was well tolerated, with no new safety signals identified.
CONCLUSIONS


In a primary care setting, Centers for Medicare and Medicaid Services-based IBT produced clinically meaningful weight loss at 56 weeks, enhanced by the addition of liraglutide 3.0 mg.",2020,"Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311).","['Obesity in Primary Care', '3.0 mg (n\u2009=\u2009142) or', 'individuals with and without diabetes\xa0(SCALE', 'individuals with obesity who received']","['Liraglutide', 'liraglutide 3.0 mg', 'placebo', 'intensive behavioral therapy (IBT', 'IBT', 'liraglutide', 'liraglutide 3.0 mg plus IBT', 'Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT']","['weight loss', 'meaningful weight loss', 'Satiety and Clinical Adiposity-Liraglutide Evidence', 'mean weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0222045'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.247435,"Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311).","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Cedar Crosse Research Center, Chicago, Illinois, USA.'}, {'ForeName': 'Michael Taulo', 'Initials': 'MT', 'LastName': 'Lund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Auerbach', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22726']
618,32192275,Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting.,"PURPOSE


The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)-induced nausea and vomiting.
Materials and Methods


Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by sex, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6.
RESULTS


A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], -7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, -2.3%; 95% CI, -13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, -7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups.
CONCLUSION


In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.",2020,"In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.","['cancer patients receiving HEC', '279 patients receiving RAD (n=137) or PAD (n=142) were evaluated']","['DEX', 'PAL (0.25 mg intravenously) D1, combined with APR', 'RAD or PAD:RAM', 'ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD', 'Ramosetron', 'cisplatin-based chemotherapy', 'Dexamethasone']","['Nausea and Vomiting', 'Overall CR rates', 'Adverse events', 'Functional Living Index Emesis (FLIE) questionnaire on D0 and D6', 'overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC', 'Overall CP and TC rates for RAD and PAD', 'efficacy, safety and QOL, RAD', 'overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score', 'Quality of life', 'FLIE total score ≥ 108 (no impact on daily life']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}]","[{'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",279.0,0.262672,"In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.","[{'ForeName': 'Jin Hyoung', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Jung Hye', 'Initials': 'JH', 'LastName': 'Kwon', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun-Gyoo', 'Initials': 'YG', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Keon Uk', 'Initials': 'KU', 'LastName': 'Park', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Ho Jung', 'Initials': 'HJ', 'LastName': 'An', 'Affiliation': ""Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Mi', 'Initials': 'YM', 'LastName': 'Seol', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Hyunwoo', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology-Oncology, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Hwan-Jung', 'Initials': 'HJ', 'LastName': 'Yun', 'Affiliation': 'Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology & Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': ""Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Hunho', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong-Hoe', 'Initials': 'DH', 'LastName': 'Koo', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Gun Min', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hwa Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Cancer research and treatment : official journal of Korean Cancer Association,['10.4143/crt.2019.713']
619,32187788,Longitudinal effects of a novel advanced pneumatic compression device on patient-reported outcomes in the management of cancer-related head and neck lymphedema: A preliminary report.,"BACKGROUND


Head and neck cancer (HNC) survivors experience head and neck lymphedema (HNL), which requires treatment to prevent morbidity. We explore the self-reported outcomes and satisfaction of patients with HNC receiving treatment for HNL with an advanced pneumatic compression device (APCD).
METHODS


HNC survivors (n = 205) prescribed with an at-home Flexitouch head and neck APCD completed pretreatment and posttreatment self-reported assessments addressing efficacy, function, and symptoms. Participant average age was 60 years with 74% male. Pre-post responses for ≥25 days of use were assessed via the non-parametric Wilcoxon Signed Rank test.
RESULTS


Analysis revealed statistically significant improvement in all symptoms and all function items (P < 0.00001). Compliance with prescribed therapy (at least 30 minutes daily) was high with 71% of participants reporting daily use and 87% reporting overall satisfaction.
CONCLUSIONS


The reported improvements in function and symptoms, and high compliance rate, provide a rationale for a subsequent randomized controlled trial.",2020,"RESULTS


Analysis revealed statistically significant improvement in all symptoms and all function items (P < 0.00001).","['Head and neck cancer (HNC) survivors experience head and neck lymphedema (HNL', 'HNC survivors (n = 205) prescribed with an at-home Flexitouch head and neck APCD completed pretreatment and posttreatment self-reported assessments addressing efficacy, function, and symptoms', 'cancer-related head and neck lymphedema', 'Participant average age was 60\u2009years with 74% male. Pre-post responses for ≥25\u2009days of use were assessed via the non-parametric Wilcoxon Signed Rank test', 'patients with HNC receiving treatment for HNL with an advanced pneumatic compression device (APCD']",['novel advanced pneumatic compression device'],"['function and symptoms, and high compliance rate', 'all symptoms and all function items']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.0888776,"RESULTS


Analysis revealed statistically significant improvement in all symptoms and all function items (P < 0.00001).","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gutiérrez', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, The University of Texas Health Science Center / McGovern Medical School, Houston, Texas.'}, {'ForeName': 'Harvey N', 'Initials': 'HN', 'LastName': 'Mayrovitz', 'Affiliation': 'Division of Physiology, Department of Medical Education, Nova Southeastern University, Dr. Kiran C. Patel College of Allopathic Medicine, Fort Lauderdale, Florida.'}, {'ForeName': 'Syed Hassan Shiraz', 'Initials': 'SHS', 'LastName': 'Naqvi', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, The University of Texas Health Science Center / McGovern Medical School, Houston, Texas.'}, {'ForeName': 'Ron J', 'Initials': 'RJ', 'LastName': 'Karni', 'Affiliation': 'Division of Head & Neck Surgical Oncology, Department of Otorhinolaryngology - Head & Neck Surgery Division of Medical Oncology, The University of Texas Health Science Center / McGovern Medical School, Houston, Texas.'}]",Head & neck,['10.1002/hed.26110']
620,32179587,Lifestyle modification in older versus younger patients with coronary artery disease.,"OBJECTIVE


To compare the treatment effect on lifestyle-related risk factors (LRFs) in older (≥65 years) versus younger (<65 years) patients with coronary artery disease (CAD) in The Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 (RESPONSE-2) trial.
METHODS


The RESPONSE-2 trial was a community-based lifestyle intervention trial (n=824) comparing nurse-coordinated referral with a comprehensive set of three lifestyle interventions (physical activity, weight reduction and/or smoking cessation) to usual care. In the current analysis, our primary outcome was the proportion of patients with improvement at 12 months follow-up (n=711) in ≥1 LRF stratified by age.
RESULTS


At baseline, older patients (n=245, mean age 69.2±3.9 years) had more adverse cardiovascular risk profiles and comorbidities than younger patients (n=579, mean age 53.7±6.6 years). There was no significant variation on the treatment effect according to age (p value treatment by age=0.45, OR 1.67, 95% CI 1.22 to 2.31). However, older patients were more likely to achieve ≥5% weight loss (OR old 5.58, 95% CI 2.77 to 11.26 vs OR young 1.57, 95% CI 0.98 to 2.49, p=0.003) and younger patients were more likely to show non-improved LRFs (OR old 0.38, 95% CI 0.22 to 0.67 vs OR young 0.88, 95% CI 0.61 to 1.26, p=0.01).
CONCLUSION


Despite more adverse cardiovascular risk profiles and comorbidities among older patients, nurse-coordinated referral to a community-based lifestyle intervention was at least as successful in improving LRFs in older as in younger patients. Higher age alone should not be a reason to withhold lifestyle interventions in patients with CAD.",2020,"There was no significant variation on the treatment effect according to age (p value treatment by age=0.45, OR 1.67, 95% CI 1.22 to 2.31).","['older (≥65 years) versus younger (<65 years) patients with coronary artery disease (CAD) in The Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 (RESPONSE-2) trial', 'patients with CAD', 'older patients (n=245, mean age 69.2±3.9 years) had more adverse cardiovascular risk profiles and comorbidities than younger patients (n=579, mean age 53.7±6.6 years', 'older versus younger patients with coronary artery disease', 'older patients']","['nurse-coordinated referral to a community-based lifestyle intervention', 'nurse-coordinated referral with a comprehensive set of three lifestyle interventions (physical activity, weight reduction and/or smoking cessation) to usual care']","['weight loss', 'LRFs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4277711', 'cui_str': 'Nurse Specialists'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",824.0,0.0563912,"There was no significant variation on the treatment effect according to age (p value treatment by age=0.45, OR 1.67, 95% CI 1.22 to 2.31).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jepma', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands p.jepma@amsterdamumc.nl.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Jorstad', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Snaterse', 'Affiliation': 'Achieve Centre for Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Ter Riet', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kragten', 'Affiliation': 'Cardiology, Zuyderland Medical Centre, Heerlen, The Netherlands.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Lachman', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'Minneboo', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'S Matthijs', 'Initials': 'SM', 'LastName': 'Boekholdt', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ron J', 'Initials': 'RJ', 'LastName': 'Peters', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Scholte Op Reimer', 'Affiliation': 'Achieve Centre for Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-316056']
621,31788775,Comparison of Hemodynamic Stability and Pain Control in Lateral and Prone Positions in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Trial.,"PURPOSE


Percutaneous nephrolithotomy (PCNL) is the preferred surgical treatment in many cases of kidney stones which is performed in different positions such as prone, lateral, and supine. This study was designed to evaluate whether patient position (lateral versus . prone) has an effect on the need for analgesia and onset of pain after surgery.
MATERIALS AND METHODS


Patient with confirmed kidney stones (size ? 2 cm) who were candidates for PCNL were enrolled in this study. The required biochemical analyses were performed preoperatively. All patients  underwent spinal anesthesia by the same anesthesiologists and then were randomly divided into two separate groups as lateral (L) and prone (P) positions. The operations' start and end time, required time for proper access into target calyces, additional need for analgesic or cardiac drugs, duration of analgesia, and onset of pain after PCNL were carefully recorded and then compared between the two groups.
RESULTS


In total, 51 patients were evaluated of whom 39 were men and 12 were women. Mean duration of analgesia after PCNL surgery in P group (173 ± 8 min) was significantly longer than in L group (147±12 min) (P = .001). Furthermore, the amount of ephedrine usage in L group (3.6 ± 1.5mg) was significantly lower than in the P group (16.4 ± 12mg), suggesting more hemodynamic variations in the P group during the operation.
CONCLUSION


Our randomized control trial study shows that choosing the optimal position in the PCNL technique depends on  patient's condition. If hemodynamic control is of matter to the anesthesiologist, then lateral position is more appropriate. However, if control of pain and longer time of analgesia are important,  prone position may be preferred.",2020,Duration of analgesia after PCNL surgery in P group (173±8 min) was significantly longer than in L group (147±12 min) (P=.001).,"['Patient with confirmed kidney stones (size ', '51 patients were evaluated of whom 39 were men and 12 were women', 'Patients undergoing Percutaneous Nephrolithotomy', '2 cm) who were candidate for PCNL']","['Hemodynamic Stability and Pain Control', 'Percutaneous Nephrolithotomy (PCNL']","['hemodynamic variations', ""operations' start and end time, required time for proper access into target calyces, additional need for analgesic or cardiac drugs, duration of analgesia, and onset of pain after PCNL"", 'Duration of analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0022651', 'cui_str': 'Kidney Calices'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",51.0,0.0301034,Duration of analgesia after PCNL surgery in P group (173±8 min) was significantly longer than in L group (147±12 min) (P=.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Roodneshin', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. dr_roodneshin_f2007@yahoo.com.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Poor Zamany Nejat Kermany', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Ahmadzadeh', 'Affiliation': 'Mofid Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Gharaei', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Kamranmanesh', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4915']
622,31808248,Lifestyle information and commercial weight management groups to support maternal postnatal weight management and positive lifestyle behaviour: the SWAN feasibility randomised controlled trial.,"OBJECTIVES


To assess feasibility of a future randomised controlled trial (RCT) of clinical and cost-effectiveness of lifestyle information and commercial weight management groups to support postnatal weight management to 12 months post-birth.
DESIGN


Two-arm feasibility trial, with nested mixed-methods process evaluation.
SETTING


Inner-city unit, south England.
POPULATION


Women with body mass indices (BMIs) ≥25 kg/m 2  at pregnancy booking or normal BMIs (18.5-24.9 kg/m 2  ) identified with excessive gestational weight gain at 36 weeks of gestation.
METHODS


Randomised to standard care plus commercial weight management sessions commencing 8-16 weeks postnatally or standard care only.
MAIN OUTCOMES


Feasibility outcomes included assessment of recruitment, retention, acceptability and economic data collation. Primary and secondary end points included difference between groups in weight 12 months postnatally compared with booking (proposed primary outcome for a future trial), diet, physical activity, smoking, alcohol, mental health, infant feeding, NHS resource use.
RESULTS


In all, 193 women were randomised: 98 intervention and 95 control; only four women had excessive gestational weight gain. A slightly greater weight change was found among intervention women at 12 months, with greatest benefit. Among women attending ten or more weight management sessions. There was >80% follow up to 12 months, low risk of contamination and no group differences in trial completion.
CONCLUSION


It was feasible to recruit and retain women with BMIs ≥25 kg/m 2  to an intervention to support postnatal weight management; identification of excessive gestational weight gain requires consideration. Economic modelling could inform out-of-trial costs and benefits in a future trial. A definitive trial is an important next step.
TWEETABLE ABSTRACT


A feasibility RCT of postnatal weight support showed women with BMIs ≥25 kg/m 2  can be recruited and followed to 12 months postnatally.",2020,"A slightly greater weight change was found among intervention women at 12 months, with greatest benefit.","['193 women were randomised: 98 intervention and 95 control; only four women had excessive gestational weight gain', 'women attending ten or more weight management sessions', 'Women with body mass indices (BMIs) ≥25\xa0kg', 'women with BMIs ≥25\xa0kg/m 2  can be recruited and followed to 12\xa0months postnatally', 'Inner-city unit, south England', 'groups to support maternal postnatal weight management and positive lifestyle behaviour']","['Lifestyle information and commercial weight management', 'lifestyle information and commercial weight management']","['assessment of recruitment, retention, acceptability and economic data collation', 'excessive gestational weight gain', 'diet, physical activity, smoking, alcohol, mental health, infant feeding, NHS resource use', 'weight change']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",193.0,0.163145,"A slightly greater weight change was found among intervention women at 12 months, with greatest benefit.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'School of Health Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bhavnani', 'Affiliation': 'NCT, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""Kings Health Economics, Health Services and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': ""Kings Health Economics, Health Services and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zasada', 'Affiliation': 'School of Health Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avery', 'Affiliation': 'Faculty of Science, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Craig', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Khazaezadah', 'Affiliation': 'Public Health, London Borough of Lambeth, Lambeth, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McMullen', 'Affiliation': 'NCT, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Connor"", 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Oki', 'Affiliation': 'Public Health, London Borough of Lambeth, Lambeth, London, UK.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Ntim', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, King's College London, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16043']
623,32170259,Blended learning as an adjunct to tutor-led seminars in undergraduate orthodontics: a randomised controlled trial.,"Aims To describe the use of blended learning as a method of undergraduate orthodontic teaching delivery and to assess its effectiveness in terms of knowledge gain.Design Randomised controlled trial.Setting Queen Mary University of London.Materials and methods Seventy dental undergraduate students in their fifth year were randomly allocated to receive orthodontic seminar-based teaching either using a blended approach based on an e-learning resource or with no prior teaching. All students were asked to complete tests both before (T0) and after (T1) the study period.Results The mean post-test score in the intervention group was 98.3% (a 19% improvement on baseline), while the mean score in the control group was 97.2% with intra-group improvements being statistically significant in both groups (P <0.001). However, no significant difference in terms of improvement in knowledge was found between the two groups (P = 0.36). In terms of satisfaction, 82% of the blended group and 74% in the control group rated the teaching as 'very good'.Conclusions An undergraduate orthodontic-oral surgery e-learning adjunct to traditional teaching was successfully developed. Blending and traditional seminar teaching appear to be equally effective in terms of short-term knowledge gain, with high levels of learner satisfaction common to both approaches.",2020,"However, no significant difference in terms of improvement in knowledge was found between the two groups (P = 0.36).","['Materials and methods Seventy dental undergraduate students in their fifth year', 'Setting Queen Mary University of London', 'undergraduate orthodontics']","['blended learning', 'Blended learning', 'orthodontic seminar-based teaching either using a blended approach based on an e-learning resource or with no prior teaching']","['knowledge', 'mean score', 'mean post-test score']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}]","[{'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",70.0,0.0693456,"However, no significant difference in terms of improvement in knowledge was found between the two groups (P = 0.36).","[{'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Jeganathan', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Padhraig S', 'Initials': 'PS', 'LastName': 'Fleming', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. padhraig.fleming@qmul.ac.uk.'}]",British dental journal,['10.1038/s41415-020-1332-1']
624,32179562,Effect of tart cherry juice on risk of gout attacks: protocol for a randomised controlled trial.,"INTRODUCTION


Gout is a painful form of inflammatory arthritis associated with several comorbidities, particularly cardiovascular disease. Cherries, which are rich in anti-inflammatory and antioxidative bioactive compounds, are proposed to be efficacious in preventing and treating gout, but recommendations to patients are conflicting. Cherry consumption has been demonstrated to lower serum urate levels and inflammation in several small studies. One observational case cross-over study reported that cherry consumption was associated with reduced risk of recurrent gout attacks. This preliminary evidence requires substantiation. The proposed randomised clinical trial aims to test the effect of consumption of tart cherry juice on risk of gout attacks.
METHODS AND ANALYSIS


This 12-month, parallel, double-blind, randomised, placebo-controlled trial will recruit 120 individuals (aged 18-80 years) with a clinical diagnosis of gout who have self-reported a gout flare in the previous year. Participants will be randomly assigned to an intervention group, which will receive Montmorency tart cherry juice daily for a 12-month period, or a corresponding placebo group, which will receive a cherry-flavoured placebo drink. The primary study outcome is change in frequency of self-reported gout attacks. Secondary outcome measures include attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk. Other secondary outcome measures will be changes in physical activity and functional status. Statistical analysis will be conducted on an intention-to-treat basis.
ETHICS AND DISSEMINATION


This study has been granted ethical approval by the National Research Ethics Service, Yorkshire and The Humber-Leeds West Research Ethics Committee (ref: 18/SW/0262). Results of the trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03621215.",2020,"Secondary outcome measures include attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk.",['120 individuals (aged 18-80 years) with a clinical diagnosis of gout who have self-reported a gout flare in the previous year'],"['Montmorency tart cherry juice daily for a 12-month period, or a corresponding placebo group, which will receive a cherry-flavoured placebo drink', 'tart cherry juice', 'placebo', 'consumption of tart cherry juice']","['physical activity and functional status', 'change in frequency of self-reported gout attacks', 'attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk', 'risk of gout attacks']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0982074', 'cui_str': 'CHERRY JUICE'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0330657', 'cui_str': 'Pie Cherry'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2712871', 'cui_str': 'Gout attack'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",120.0,0.612956,"Secondary outcome measures include attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk.","[{'ForeName': 'Kirstie Louise', 'Initials': 'KL', 'LastName': 'Lamb', 'Affiliation': 'Food and Nutrition Group, Sheffield Business School, Sheffield Hallam University, Sheffield, UK kirstie.lamb@student.shu.ac.uk.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lynn', 'Affiliation': 'Food and Nutrition Group, Sheffield Business School, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'Corporate Information and Computing Services, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Margo E', 'Initials': 'ME', 'LastName': 'Barker', 'Affiliation': 'Food and Nutrition Group, Sheffield Business School, Sheffield Hallam University, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035108']
625,32202203,Do Patients With Parkinson's Disease With Freezing of Gait Respond Differently Than Those Without to Treadmill Training Augmented by Virtual Reality?,"Background . People with Parkinson's disease and freezing of gait (FOG+) have more falls, postural instability and cognitive impairment compared with FOG-.  Objective . To conduct a secondary analysis of the V-TIME study, a randomized, controlled investigation showing a greater reduction of falls after virtual reality treadmill training (TT + VR) compared with usual treadmill walking (TT) in a mixed population of fallers. We addressed whether these treadmill interventions led to similar gains in FOG+ as in FOG-.  Methods . A total of 77 FOG+ and 44 FOG- were assigned randomly to TT + VR or TT. Participants were assessed pre- and posttraining and at 6 months' follow-up. Main outcome was postural stability assessed by the Mini Balance Evaluation System Test (Mini-BEST) test. Falls were documented using diaries. Other outcomes included the New Freezing of Gait Questionnaire (NFOG-Q) and the Trail Making Test (TMT-B).  Results . Mini-BEST scores and the TMT-B improved in both groups after training ( P  = .001), irrespective of study arm and FOG subgroup. However, gains were not retained at 6 months. Both FOG+ and FOG- had a greater reduction of falls after TT + VR compared with TT ( P  = .008). NFOG-Q scores did not change after both training modes in the FOG+ group.  Conclusions . Treadmill walking (with or without VR) improved postural instability in both FOG+ and FOG-, while controlling for disease severity differences. As found previously, TT + VR reduced falls more than TT alone, even among those with FOG. Interestingly, FOG itself was not helped by training, suggesting that although postural instability, falls and FOG are related, they may be controlled by different mechanisms.",2020,"Mini-BEST scores and the TMT-B improved in both groups after training ( P  = .001), irrespective of study arm and FOG subgroup.","['A total of 77 FOG+ and 44 FOG', ""Patients With Parkinson's Disease With Freezing of Gait Respond"", 'mixed population of fallers', ""People with Parkinson's disease and freezing of gait (FOG""]","['virtual reality treadmill training (TT + VR', 'TT + VR', 'usual treadmill walking (TT', 'Treadmill walking (with or without VR', 'TT + VR or TT']","['postural instability', 'NFOG-Q scores', 'postural stability assessed by the Mini Balance Evaluation System Test (Mini-BEST) test', 'reduction of falls after TT + VR', 'Mini-BEST scores and the TMT-B', 'New Freezing of Gait Questionnaire (NFOG-Q) and the Trail Making Test (TMT-B']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}]",77.0,0.088833,"Mini-BEST scores and the TMT-B improved in both groups after training ( P  = .001), irrespective of study arm and FOG subgroup.","[{'ForeName': 'Esther M J', 'Initials': 'EMJ', 'LastName': 'Bekkers', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Alcock', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Nieuwhof', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pelosin', 'Affiliation': 'University of Genoa, Genoa, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Avanzino', 'Affiliation': 'University of Genoa, Genoa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cereatti', 'Affiliation': 'University of Sassari, Sassari, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Della Croce', 'Affiliation': 'University of Sassari, Sassari, Italy.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320912756']
626,31994303,Comparison of the effects of oral iron treatment every day and every other day in female patients with iron deficiency anaemia.,"BACKGROUND


It is known that daily divided doses and high doses of iron increase hepcidin and reduce iron absorption.
AIM


This study aimed to compare treatments of iron replacement every other day at low doses, once a day and twice a day in terms of their effectiveness and frequencies of side effects.
METHODS


For a month, Group I received 270 mg ferrous sulphate twice a day (total elemental iron dose: 160 mg/day), Group II received 270 mg ferrous sulphate once a day (total elemental iron dose: 80 mg/day), and Group III received 270 mg ferrous sulphate every other day (total elemental iron dose: 80 mg/every other day). Intragroup and intergroup statistical analyses were carried out.
RESULTS


Haemoglobin (Hb) increased significantly in all three groups (P = 0.00). The increase in Hb levels was similar among the groups (P = 0.09). Ferritin significantly increased in all three groups after the treatment (P = 0.00). The increase in ferritin in Group I was significantly higher than those in Groups II and III (P < 0.05). Gastrointestinal tract (GIS) side effects were also significantly higher in Group I in comparison to the others (P = 0.001).
CONCLUSIONS


A low-dosage of iron treatment every other day may be used in the place of providing iron once or twice every day with similar effectiveness and lower rates of GIS side effects.",2020,"GIS side effects were also significantly higher in Group I in comparison to the others (p: 0.001).
",['Female Patients with Iron Deficiency Anemia'],"['Oral Iron Treatment', 'ferrous sulfate']","['Hemoglobin (Hb', 'Ferritin', 'Hb levels', 'increase in ferritin', 'GIS side effects']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0205757,"GIS side effects were also significantly higher in Group I in comparison to the others (p: 0.001).
","[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Demircioğlu', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Düzen Oflas', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Yıldırım Doğan', 'Affiliation': 'Department of Internal Medicine, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Elife', 'Initials': 'E', 'LastName': 'Eker', 'Affiliation': 'Department of Internal Medicine, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kutlucan', 'Affiliation': 'Department of Hematology, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Doğan', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aslan', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Demir', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}]",Internal medicine journal,['10.1111/imj.14766']
627,32053101,Evaluation of the pharmacokinetics and food intake effect of generic sofosbuvir in healthy Chinese subjects
.,"OBJECTIVE


Sofosbuvir is an NS5B nucleotide inhibitor that was approved for hepatitis C treatment. Generic sofosbuvir has been produced to improve the affordability. The present study investigated the pharmacokinetics (PK) and safety of generic sofosbuvir as well as the effect of food intake on its PK parameters in healthy Chinese subjects.
MATERIALS AND METHODS


This open-label, randomized, multiple-dose, dose-escalating, and food effect trial enrolled 12 healthy Chinese subjects. The subjects received a single oral dose of 400 mg of generic sofosbuvir in fasted state or after a high-fat meal, or 800 mg in fasted state, in a three-way crossover design, and then all subjects were administered with 400 mg daily for 8 days. The PK parameters for sofosbuvir and its metabolites were determined, and the safety was monitored.
RESULTS


Sofosbuvir was absorbed rapidly into plasma, with a half-life of 0.46 - 0.48 hours. Plasma exposure to sofosbuvir and its metabolite GS-566500 was increased in an approximately proportional manner to the increased dose. Repeated dosing did not result in drug accumulation in the blood. Sofosbuvir was mainly excreted as the metabolite GS-331007 in the urine. Drug administration after a high-fat meal increased the plasma sofosbuvir exposure by 1.29-fold, without substantially altering the absorption rate. No serious adverse events were observed, and all subjects tolerated the doses well.
CONCLUSION


This generic sofosbuvir was well absorbed, the plasma concentration was increased with an increased dose, and it was safe in healthy subjects. A high-fat meal appeared to promote the bioavailability of sofosbuvir and the metabolite GS-566500.",2020,A high-fat meal appeared to promote the bioavailability of sofosbuvir and the metabolite GS-566500.
.,"['healthy Chinese subjects', '12 healthy Chinese subjects', 'healthy subjects', 'healthy Chinese subjects\u2029']","['single oral dose of 400\xa0mg of generic sofosbuvir in fasted state or after a high-fat meal, or 800\xa0mg in fasted state', 'generic sofosbuvir']","['Plasma exposure to sofosbuvir and its metabolite GS-566500', 'serious adverse events', 'plasma concentration', 'plasma sofosbuvir exposure', 'absorption rate']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",12.0,0.0315775,A high-fat meal appeared to promote the bioavailability of sofosbuvir and the metabolite GS-566500.
.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yiya', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203649']
628,31529104,Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial.,"OBJECTIVE


Sleep disturbance may limit improvement in pain outcomes if not directly addressed in treatment. Moreover, sleep problems may be exacerbated by opioid therapy. This study examined the effects of baseline sleep disturbance on improvement in pain outcomes using data from the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial, a pragmatic 12-month randomized trial of opioid vs nonopioid medication therapy.
DESIGN


Participants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120).
METHODS


We used mixed models for repeated measures to 1) test whether baseline sleep disturbance scores modified the effect of opioid vs nonopioid treatment on pain outcomes and 2) test baseline sleep disturbance scores as a predictor of less improvement in pain outcomes across both treatment groups.
RESULTS


The tests for interaction of sleep disturbance by treatment group were not significant. Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).
CONCLUSIONS


Baseline sleep disturbance adversely affects pain response to treatment regardless of analgesic regimen. Recognition and treatment of sleep impairments that frequently co-occur with pain may optimize outcomes.",2020,"Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).
",['Participants with chronic back pain or hip or knee osteoarthritis pain'],"['opioid vs nonopioid medication therapy', 'opioid vs nonopioid treatment', 'opioid therapy (N\u2009=\u2009120) or nonopioid medication therapy (N\u2009=\u2009120']","['pain outcomes', 'sleep disturbance', 'Higher sleep disturbance scores', 'Brief Pain Inventory (BPI) interference', 'pain response', 'BPI severity', 'pain outcomes and 2) test baseline sleep disturbance scores']","[{'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.122586,"Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).
","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Koffel', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Allyson M', 'Initials': 'AM', 'LastName': 'Kats', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gravely', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'DeRonne', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Melvin T', 'Initials': 'MT', 'LastName': 'Donaldson', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Goldsmith', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Krebs', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz221']
629,32189108,'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab.,"BACKGROUND


The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension.
METHODS


Attainment of 'minimal symptom expression' was evaluated using patient-reported outcome measures of gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15)] at the completion of REGAIN and during the open-label extension. 'Minimal symptom expression' was defined as MG-ADL total score of 0-1 or MG-QOL15 total score of 0-3.
RESULTS


At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069]. During the open-label extension, the proportion of patients in the placebo/eculizumab group who achieved 'minimal symptom expression' increased after initiating eculizumab treatment and was sustained through 130 weeks of open-label eculizumab (MG-ADL: 1.7 to 27.8%; MG-QOL15: 1.7 to 19.4%). At extension study week 130, similar proportions of patients in the eculizumab/eculizumab and placebo/eculizumab groups achieved 'minimal symptom expression' (MG-ADL: 22.9% and 27.8%, respectively, p = 0.7861; MG-QOL15: 14.3% and 19.4%, respectively, p = 0.7531). The long-term tolerability of eculizumab was consistent with previous reports.
CONCLUSIONS


Patients with AChR+ refractory gMG who receive eculizumab can achieve sustained 'minimal symptom expression' based on patient-reported outcomes. 'Minimal symptom expression' may be a useful tool in measuring therapy effectiveness in gMG.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01997229, NCT02301624.",2020,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","['patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with', 'Patients with AChR+ refractory gMG']","['placebo/eculizumab', 'acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG', 'placebo', 'eculizumab/eculizumab and placebo/eculizumab', 'placebo [MG-ADL', 'open-label eculizumab (MG-ADL', 'eculizumab']","['minimal symptom expression', 'Minimal symptom expression', 'gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0765796', 'cui_str': 'GMG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0905574,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Department of Neurology, Copenhagen Neuromuscular Center, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark. john.vissing@regionh.dk.'}, {'ForeName': 'Saiju', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Queen Elizabeth Neuroscience Centre and Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Kenji P', 'Initials': 'KP', 'LastName': 'Fujita', 'Affiliation': 'Alnylam Pharmaceuticals, 675 West Kendall Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': ""O'Brien"", 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA, 02210, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'Department of Neurology, University of North Carolina, 170 Manning Drive, Chapel Hill, NC, 27599-7025, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09770-y']
630,32186028,"Effect of cream, prepared with Tripterygium wilfordii Hook F and other four medicinals, on joint pain and swelling in patients with rheumatoid arthritis: a double-blinded, randomized, placebo controlled clinical trial.","OBJECTIVE


To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis (RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F (TwHF), Mangxiao (Nalrii Sulfas), Chuanxiong (Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang (Olibanum), and stir-frying with liquid adjuvant Moyao (Myrrh).
METHODS


Patients were 1∶1 randomized to add-on TwHF cream twice a day or placebo for 4 weeks. The primary endpoint was achievement rate of 20% improvement in American College of Rheumatology criteria (ACR20) at week 4. Secondary endpoints were ACR50, 28-joint count Disease Activity Score (DAS28) improvement and safety profiles. Statistical analyses were performed using intention to treat analysis (ITT) set.
RESULTS


A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3% (12/35) in TwHF cream group and 11.4% (4/35) in placebo group (P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1% (6/35) comparing to it in placebo group with 2.9% (1/35) (P = 0.046). The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed.
CONCLUSION


On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA.",2019,"The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048).","['patients with rheumatoid arthritis (RA', 'patients with rheumatoid arthritis', 'Patients', '70 active RA patients were enrolled', 'patients with active RA']","['TwHF cream twice a day or placebo', 'cream', 'placebo', 'Tripterygium wilfordii Hook F and other four medicinals', 'TwHF cream', 'Tripterygium wilfordii Hook F (TwHF), Mangxiao (Nalrii Sulfas), Chuanxiong (Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang (Olibanum), and stir-frying with liquid adjuvant Moyao (Myrrh']","['higher ACR50 responder proportion', 'DAS28- CRP', 'DAS28-ESR', 'achievement rate of 20% improvement in American College of Rheumatology criteria (ACR20', 'tender joint count', ""Physician's global assessment"", 'ACR20', 'substantive adverse events', 'joint pain and swelling', 'ACR50, 28-joint count Disease Activity Score (DAS28) improvement and safety profiles', 'swollen joint count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0077273', 'cui_str': 'Tripterygium wilfordii'}, {'cui': 'C0181209', 'cui_str': 'Hook (attribute)'}, {'cui': 'C0257081', 'cui_str': 'mangxiao'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count (assessment scale)'}]",70.0,0.433217,"The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Xiaopo', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences,Beijing 100053, China.""}, {'ForeName': 'Chengchung', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
631,32139496,"Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial).","INTRODUCTION


Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice.
METHODS AND ANALYSIS


In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed.
ETHICS AND DISSEMINATION


Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.
TRIAL REGISTRATION NUMBER


ISRCTN42499563.",2020,"Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.
","['people with insomnia disorder', '588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either']","['Multicomponent cognitive-behavioural therapy (CBT', 'SRT', 'nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet', 'nurse-delivered SRT', 'nurse-delivered sleep restriction therapy', 'Sleep restriction therapy (SRT']","['health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity', 'self-reported insomnia severity using the Insomnia Severity Index']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}]",588.0,0.143253,"Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.
","[{'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, University of Oxford, Oxford, UK simon.kyle@ndcn.ox.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Madigan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nargis', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Abel', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Armstrong', 'Affiliation': 'School of Health and Social Care, Community and Health Research Unit, College of Social Science, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ogburn', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aloysius', 'Initials': 'A', 'LastName': 'Siriwardena', 'Affiliation': 'School of Health and Social Care, Community and Health Research Unit, College of Social Science, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036248']
632,32150057,Peer support for discharge from inpatient to community mental health services: Study protocol clinical trial (SPIRIT Compliant).,"INTRODUCTION


In the period shortly after discharge from inpatient to community mental health care, people are at increased risk of self-harm, suicide, and readmission to hospital. Discharge interventions including peer support have shown potential, and there is some evidence that community-based peer support reduces readmissions. However, systematic reviews of peer support in mental health services indicate poor trial quality and a lack of reporting of how peer support is distinctive from other mental health support. This study is designed to establish the clinical and cost effectiveness of a peer worker intervention to support discharge from inpatient to community mental health care, and to address issues of trial quality and clarity of reporting of peer support interventions.
METHODS


This protocol describes an individually randomized controlled superiority trial, hypothesizing that people offered a peer worker discharge intervention in addition to usual follow-up care in the community are less likely to be readmitted in the 12 months post discharge than people receiving usual care alone. A total of 590 people will be recruited shortly before discharge from hospital and randomly allocated to care as usual plus the peer worker intervention or care as usual alone. Manualized peer support provided by trained peer workers begins in hospital and continues for 4 months in the community post discharge. Secondary psychosocial outcomes are assessed at 4 months post discharge, and service use and cost outcomes at 12 months post discharge, alongside a mixed methods process evaluation.
DISCUSSION


Clearly specified procedures for sequencing participant allocation and for blinding assessors to allocation, plus full reporting of outcomes, should reduce risk of bias in trial findings and contribute to improved quality in the peer support evidence base. The involvement of members of the study team with direct experience of peer support, mental distress, and using mental health services, in coproducing the intervention and designing the trial, ensures that we theorize and clearly describe the peer worker intervention, and evaluate how peer support is related to any change in outcome. This is an important methodological contribution to the evidence base.
TRIAL REGISTRATION


This study was prospectively registered as ISRCTN 10043328 on November 28, 2016.",2020,"In the period shortly after discharge from inpatient to community mental health care, people are at increased risk of self-harm, suicide, and readmission to hospital.","['November 28, 2016', '590 people will be recruited shortly before discharge from hospital and randomly allocated to']","['care as usual plus the peer worker intervention or care as usual alone', 'peer worker intervention', 'peer worker discharge intervention']","['discharge, and service use and cost outcomes']","[{'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",590.0,0.157639,"In the period shortly after discharge from inpatient to community mental health care, people are at increased risk of self-harm, suicide, and readmission to hospital.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gillard', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton & Sussex Medical School, University of Brighton, Brighton.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Sarah Louise', 'Initials': 'SL', 'LastName': 'Gibson', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Goldsmith', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""Health Services & Population Research Department, King's College London, London.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lucock', 'Affiliation': 'School of Human & Health Sciences, University of Huddersfield, Huddersfield.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Marks', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Rosaleen', 'Initials': 'R', 'LastName': 'Morshead', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Pragmatic Clinical Trials Unit.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary, University of London, London.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Repper', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Rinaldi', 'Affiliation': ""South West London & St George's Mental Health NHS Trust.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': ""Health Services & Population Research Department, King's College London, London.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': ""Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}]",Medicine,['10.1097/MD.0000000000019192']
633,31953832,Comparison of Removing Double-J Stent With and Without Cystoscopy in Kidney Transplant Patients: A Randomized Clinical Trial.,"PURPOSE


The ureteric stent can be attached to the Foley catheter in kidney transplantation to exclude cystoscopy for its removal. It is rarely practiced in renal transplantation. There has been no randomized trial to evaluate the outcome of this procedure on major urologic complications.
MATERIALS AND METHODS


One hundred sixty-three kidney transplant patients were randomized into an intervention group in which the stent was attached to the Foley catheter and removed together and a control group in which stent was removed by cystoscopy. In both groups, stents were removed around the 8th post-operative day.
RESULTS


From March 2016 to June 2017, out of 234 kidney transplants performed in our center, one hundred Sixty-three (69.6%) patients met the study inclusion criteria.  91patients (55.8%) were allocated to the intervention group. Mean days before JJ removal for intervention and control groups (""per-protocol"" group) were 8.08 ± 1.52 and 8.57 ± 1.58, respectively (P = .09). There was no difference between groups regarding major urologic complications (P = .679). Visual analog scale pain scores were significantly higher in the control group (p = .001). The procedure reduced 63-120 USD from the cost of operation in the intervention group.
CONCLUSION


In selected kidney transplant patients, attaching stent to the Foley catheter and removing both of them early may be a safe maneuver regarding major urological complications, reduces pain, and eliminates the cost of cystoscopy.",2020,Visual analog scale pain scores were significantly higher in the control group (p=.001).,"['One hundred sixty-three kidney transplant patients', 'Kidney Transplant Patients', 'From March 2016 to June 2017, out of 234 kidney transplants performed in our center, a hundred Sixty-three (69.6%) patients met the study inclusion criteria']","['stent attached to the Foley catheter and removed together and a control group in which stent removed by cystoscopy', 'Removing Double-J Stent With and Without Cystoscopy']","['Visual analog scale pain scores', 'Mean days before JJ removal', 'major urologic complications']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0179804'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent (physical object)'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",163.0,0.0731579,Visual analog scale pain scores were significantly higher in the control group (p=.001).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nadjafi-Semnani', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran. monadjafi@gmail.com.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Simforoosh', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tabibi', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nadjafi-Semnani', 'Affiliation': 'Resident in General Surgery, Shiraz, Iran.'}]",Urology journal,['10.22037/uj.v0i0.5448']
634,32168090,Mindfulness Meditation and Anxiety in Nursing Students.,"This quasi-experimental study used a convenience sample of nursing students (n = 49) to evaluate the effectiveness of mindfulness meditation on anxiety. Students participated in mindfulness meditation sessions and completed the State-Trait Anxiety Inventory. A statistically significant reduction in trait anxiety was found in the intervention group (p = .000); state anxiety decreased but not significantly. In contrast, anxiety increased significantly in the comparison group, but progression was not significantly different between groups. Trait anxiety may decrease with mindfulness meditation.",2020,A statistically significant reduction in trait anxiety was found in the intervention group (p = .000); state anxiety decreased but not significantly.,"['convenience sample of nursing students (n = 49', 'Nursing Students']","['mindfulness meditation', 'mindfulness meditation sessions']","['state anxiety', 'anxiety', 'Mindfulness Meditation and Anxiety', 'Trait anxiety', 'trait anxiety']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]",,0.0156542,A statistically significant reduction in trait anxiety was found in the intervention group (p = .000); state anxiety decreased but not significantly.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Stinson', 'Affiliation': 'About the Authors Cynthia Stinson PhD, APRN, CNS, RN-BC, is chair and associate professor; Eileen Curl, PhD, RN, ANEF, is professor and director of research; Gina Hale, PhD, RN, CNE, is assistant professor; Stacey Knight, DNP, RN, CNE, is assistant professor; Cynthia Pipkins, PhD, RN, HNB-BC, is assistant professor; Iva Hall, PhD, RN, is associate professor; Kelli White, MSN, RN, is an instructor, JoAnne Gay Dishman School of Nursing, Lamar University, Beaumont, Texas. Nancy Thompson, LCSW, RN, is a licensed clinical social worker and nurse, Beaumont, Texas. Christy Wright, MSN, RN, former graduate assistant at Dishman School of Nursing, is a staff nurse, CHRISTUS Southeast Texas St. Elizabeth, Beaumont, Texas.'}, {'ForeName': 'Eileen Deges', 'Initials': 'ED', 'LastName': 'Curl', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Hale', 'Affiliation': ''}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Knight', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pipkins', 'Affiliation': ''}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': ''}]",Nursing education perspectives,['10.1097/01.NEP.0000000000000635']
635,32172488,"An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects.","BACKGROUND AND OBJECTIVES


YLB113 is being developed as a biosimilar of the antitumor necrosis factor-alpha antagonist etanercept, which is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) and other chronic immune-mediated inflammatory diseases. An open-label, crossover, pharmacokinetic study was conducted to compare the relative bioavailability and safety of YLB113 and the etanercept reference product (RP) Enbrel ® .
METHODS


Healthy male subjects aged 18-50 years were randomized to receive a single subcutaneous dose of YLB113 in one period and the etanercept RP in another period. A washout period of 28 days separated the two treatment periods. Blood samples were collected for pharmacokinetic analysis predose and until 480 h postdose during both periods.
RESULTS


Overall, 52 subjects were enrolled, including 51 subjects who completed the first period and 43 subjects who completed the second period. The 90% confidence intervals for the least squares means derived from an analysis of the log-transformed pharmacokinetic parameters maximum serum concentration (C max ), area under the serum concentration-time curve (AUC) from 0 to the last measurable concentration (AUC (0-t) ) and AUC from 0 to infinity (AUC (0-∞) ) for etanercept were between the limits of 80 and 125%. Thus, YLB113 met the bioequivalence criterion. YLB113 and the etanercept RP were well tolerated, with 24 subjects reporting 53 adverse events, including 42 mild and 11 moderate events. Treatment-emergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively.
CONCLUSIONS


A single dose of YLB113 exhibited pharmacokinetic and safety profiles comparable with those of the etanercept RP in healthy adult male subjects. Therefore, YLB113 and the etanercept RP can be considered bioequivalent. These findings support the continued development of YLB113 for use in patients with RA.
JORDAN FOOD & DRUG ADMINISTRATION UNIQUE TRIAL NUMBER


31/Clinical/2018.",2020,"Treatment-emergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively.
","['52 subjects were enrolled, including 51 subjects who completed the first period and 43 subjects who completed the second period', 'Healthy male subjects aged 18-50\xa0years', 'healthy adult male subjects', 'patients with RA', 'Healthy Adult Male Subjects']","['etanercept RP', 'YLB113']","['relative bioavailability and safety of YLB113', 'log-transformed pharmacokinetic parameters maximum serum concentration (C max ), area under the serum concentration-time curve (AUC)\xa0from 0 to the last measurable concentration (AUC (0-t) ) and AUC\xa0from 0 to infinity (AUC (0-∞) ) for etanercept']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]",52.0,0.0293433,"Treatment-emergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively.
","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Shennak', 'Affiliation': 'Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan. PI@triumpharma.com.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Al-Jaouni', 'Affiliation': 'Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Kshirasagar', 'Affiliation': 'Lupin Limited, Mumbai, India.'}, {'ForeName': 'Ravi Sekhar', 'Initials': 'RS', 'LastName': 'Kasibhatta', 'Affiliation': 'Lupin Limited, Mumbai, India.'}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Godse', 'Affiliation': 'Lupin Limited, Mumbai, India.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Ghazawi', 'Affiliation': 'Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Vittala', 'Affiliation': 'Lupin Limited, Mumbai, India.'}, {'ForeName': 'Dhananjay', 'Initials': 'D', 'LastName': 'Bakhle', 'Affiliation': 'Lupin Limited, Mumbai, India.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00613-9']
636,32032736,"Development and evaluation of an 1-day Acceptance and Commitment Therapy workshop for Veterans with comorbid chronic pain, TBI, and psychological distress: Outcomes from a pilot study.","OBJECTIVES


To 1) develop and refine a 1-day trans-diagnostic psychotherapeutic ""ACT on Life"" workshop tailored for Veterans with mild traumatic brain injury, stress-based psychopathology, and pain; 2) examine the feasibility, acceptability, and preliminary effects of this intervention.
SETTING


A Veterans Health Administration medical center.
PARTICIPANTS


Veterans returning from Operations Iraqi Freedom, Enduring Freedom, and New Dawn with mild TBI, stress-based psychopathology, and chronic pain.
DESIGN


Phase I involved development of the intervention by experts and subsequent refinement based on Veteran feedback (N = 11). Phase II was a pilot randomized controlled trial comparing the effects of the revised intervention (N = 20) to treatment as usual (TAU; N = 12).
MAIN MEASURES


For phase I, qualitative feedback at 2 weeks and 3 months post-workshop was obtained from Veterans. For phase II, quantitative measures included the PTSD Checklist, Depression Anxiety and Stress Scale, Military-to-Civilian Questionnaire, WHO-Disability Assessment Schedule, Brief Pain Inventory, Acceptance and Action Questionnaire.
RESULTS


Veterans found the workshop acceptable, innovative and useful. Quantitative data from phase II suggested that participants in the ACT group, relative to TAU, showed improvement in psychiatric symptoms, functioning, and reintegration 3 months post-workshop. Unexpectedly, pain interference was lower in the TAU group at follow-up.
CONCLUSIONS


Preliminary results support the feasibility, acceptability, and promising effects on psychological distress and community reintegration of this 1-day, transdiagnostic workshop for Veterans. Future research examining the effectiveness of this workshop with a larger sample size is necessary.",2020,"Quantitative data from phase II suggested that participants in the ACT group, relative to TAU, showed improvement in psychiatric symptoms, functioning, and reintegration 3 months post-workshop.","['A Veterans Health Administration medical center', 'Veterans with comorbid chronic pain, TBI, and psychological distress', 'Veterans returning from Operations Iraqi Freedom, Enduring Freedom, and New Dawn with mild TBI, stress-based psychopathology, and chronic pain', 'Veterans with mild traumatic brain injury, stress-based psychopathology, and pain']","['revised intervention (N\u202f=\u202f20) to treatment as usual (TAU; N\u202f=\u202f12', '1-day Acceptance and Commitment Therapy workshop']","['psychiatric symptoms, functioning, and reintegration', 'pain interference', 'PTSD Checklist, Depression Anxiety and Stress Scale, Military-to-Civilian Questionnaire, WHO-Disability Assessment Schedule, Brief Pain Inventory, Acceptance and Action Questionnaire']","[{'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4045979', 'cui_str': 'Operation Iraqi Freedom'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule (assessment scale)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.0334592,"Quantitative data from phase II suggested that participants in the ACT group, relative to TAU, showed improvement in psychiatric symptoms, functioning, and reintegration 3 months post-workshop.","[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America. Electronic address: lilian.dindo@bcm.edu.'}, {'ForeName': 'Adrienne L', 'Initials': 'AL', 'LastName': 'Johnson', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, WI, United States of America; Center for Tobacco Research and Intervention, University of Wisconsin, Madison, WI, United States of America.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Lang', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Merlyn', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America; Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Jorge', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America; Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105954']
637,31756383,"Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC).","INTRODUCTION


Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response.
METHODS


This single-blinded randomized placebo-controlled multicenter trial aims to enroll 260 youth (ages 10-18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers. Participants will be randomly assigned to either a web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N = 130) or to a web-based pain education program (WebED; N = 130). Assessments will be completed at baseline (T1), immediately after completion of the intervention (T2) and at 6 months post-intervention (T3). The primary study outcome is abdominal pain severity. Secondary outcomes include pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization.
CONCLUSIONS


This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life. Findings will inform delivery of web-based pain management and potentially identify patient-specific biological and psychosocial factors associated with favorable response to therapy. Clinical Trial Registration #: NCT03707431.",2020,This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life.,"['enroll 260 youth (ages 10-18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis', 'children with ARP/CP', 'children with CP', 'pediatric acute recurrent and chronic pancreatitis', 'chronic pancreatitis, diabetes and pancreatic cancer (CPDPC', 'pediatric acute recurrent and chronic pancreatitis (ARP/CP']","['placebo', 'psychological pain intervention', 'web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N\u202f=\u202f130) or to a web-based pain education program (WebED; N\u202f=\u202f130', 'Web-based cognitive-behavioral intervention']","['abdominal pain severity', 'pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}]",260.0,0.161853,This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life.,"[{'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, USA; Center for Child Health, Behavior & Development, Seattle Children's Research Institute, USA. Electronic address: tonya.palermo@seattlechildrens.org.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': ""Center for Child Health, Behavior & Development, Seattle Children's Research Institute, USA.""}, {'ForeName': 'Homer', 'Initials': 'H', 'LastName': 'Aalfs', 'Affiliation': ""Center for Child Health, Behavior & Development, Seattle Children's Research Institute, USA.""}, {'ForeName': 'Maisam', 'Initials': 'M', 'LastName': 'Abu-El-Haija', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; College of Medicine, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Barth', 'Affiliation': 'University of Texas Southwestern Medical School, Dallas, TX, USA.'}, {'ForeName': 'Melena D', 'Initials': 'MD', 'LastName': 'Bellin', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ellery', 'Affiliation': ""Children's Hospital; of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Fishman', 'Affiliation': ""Section of Pediatric Gastroenterology, Hepatology and Nutrition Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Cheryl E', 'Initials': 'CE', 'LastName': 'Gariepy', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Giefer', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Goday', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Gonska', 'Affiliation': 'Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Melvin B', 'Initials': 'MB', 'LastName': 'Heyman', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sohail Z', 'Initials': 'SZ', 'LastName': 'Husain', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Tom K', 'Initials': 'TK', 'LastName': 'Lin', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; College of Medicine, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Quin Y', 'Initials': 'QY', 'LastName': 'Liu', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Maqbool', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McFerron', 'Affiliation': 'Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Veronique D', 'Initials': 'VD', 'LastName': 'Morinville', 'Affiliation': ""Montreal Children's Hospital, McGill University, Montreal, QC, Canada.""}, {'ForeName': 'Jaimie D', 'Initials': 'JD', 'LastName': 'Nathan', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; College of Medicine, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Chee Y', 'Initials': 'CY', 'LastName': 'Ooi', 'Affiliation': ""School of Women's and Children's Health, Medicine, University of New South Wales and Sydney Children's Hospital Randwick Sydney, Australia.""}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Perito', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Pohl', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sarah Jane', 'Initials': 'SJ', 'LastName': 'Schwarzenberg', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.""}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Sellers', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, MD, USA.'}, {'ForeName': 'Uzma', 'Initials': 'U', 'LastName': 'Shah', 'Affiliation': 'Massachusetts General Hospital for Children, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Troendle', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.""}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lowe', 'Affiliation': 'Washington University School of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Aliye', 'Initials': 'A', 'LastName': 'Uc', 'Affiliation': ""University of Iowa, Stead Family Children's Hospital, Iowa City, IA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105898']
638,31786150,"A randomized controlled trial of a trauma-informed school prevention program for urban youth: Rationale, design, and methods.","INTRODUCTION


Youth in disadvantaged urban areas are frequently exposed to chronic stress and trauma, including housing instability, neighborhood violence, and other poverty-related adversities. These exposures increase risk for emotional, behavioral, and academic problems and ultimately, school dropout. Schools are a promising setting in which to address these issues; however, there are few universal, trauma-informed school-based interventions for urban youth.
METHODS/DESIGN


Project POWER (Promoting Options for Wellness and Emotion Regulation) is a randomized controlled trial testing the impact of RAP Club, a trauma-informed intervention for eighth graders that includes mindfulness as a core component. Students in 32 urban public schools (n = 800) are randomly assigned to either RAP Club or a health education active control group. We assess student emotional, behavioral, and academic outcomes using self-report surveys and teacher ratings at baseline, post-intervention, and 4-month follow up. Focus groups and interviews with students, teachers, and principals address program feasibility, acceptability, and fidelity, as well as perceived program impacts. Students complete an additional self-report survey in ninth grade. Schools provide students' academic and disciplinary data for their seventh, eighth, and ninth grade years. In addition, data on program costs are collected to conduct an economic analysis of the intervention and active control programs.
DISCUSSION


Notable study features include program co-leadership by young adults from the community and building capacity of school personnel for continued program delivery. In addition to testing program impact, we will identify factors related to successful program implementation to inform future program use and dissemination.",2020,"In addition to testing program impact, we will identify factors related to successful program implementation to inform future program use and dissemination.","['Students in 32 urban public schools (n\u202f=\u202f800', 'urban youth']","['RAP Club or a health education active control group', 'trauma-informed school prevention program']","['emotional, behavioral, and academic problems and ultimately, school dropout', 'student emotional, behavioral, and academic outcomes using self-report surveys and teacher ratings']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0018701'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0000873', 'cui_str': 'Academic problem (finding)'}, {'cui': 'C0038488', 'cui_str': 'School Dropouts'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]",800.0,0.0388926,"In addition to testing program impact, we will identify factors related to successful program implementation to inform future program use and dissemination.","[{'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Mendelson', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States. Electronic address: tmendel1@jhu.edu.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Clary', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sibinga', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Tandon', 'Affiliation': 'Northwestern University, United States.'}, {'ForeName': 'Rashelle', 'Initials': 'R', 'LastName': 'Musci', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mmari', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Salkever', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stuart', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Ialongo', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105895']
639,32040077,Perspective-taking influences attentional deployment towards facial expressions of pain: an eye-tracking study.,"Empathetic perspective-taking (PT) may be critical in modulating attention and associated responses to another's pain. However, the differential effects of imagining oneself to be in the pain sufferer's situation (""Self-perspective"") or imagining the negative impacts on the pain sufferer's experience (""Other-perspective"") on attention have not been studied. The effects of observer PT (Self vs Other) and level of facial pain expressiveness (FPE) upon attention to another person's pain was investigated. Fifty-two adults were assigned to 1 of 3 PT conditions; they were instructed to view pairs of pain expressions and neutral faces and either (1) consider their own feelings (Self-perspective), (2) consider the feelings of the person in the picture (Other-perspective), or (3) received no further instructions (Control). Eye movements provided indices of early (probability and duration of first fixation) and later (total gaze duration) attentional deployment. Pain faces were more likely to be fixated upon first. A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition. The proportion of total gaze duration on pain faces was higher in both experimental conditions than the Control condition. This effect was moderated by FPE in the Self-PT condition; there was a significant increase from low to high FPE. When observers attend to another's facial display of pain, top-down influences (such as PT) and bottom-up influences (such as sufferer's FPE) interact to control deployment and maintenance of attention.",2020,"A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition.",['Fifty-two adults'],"['pain expressions and neutral faces and either 1) consider their own feelings (Self-perspective), 2) consider the feelings of the person in the picture (Other-perspective), or 3) received no further instructions (Control', 'Empathetic perspective-taking (PT', 'Perspective-taking influences attentional deployment']","['facial expressions of pain', 'proportion of total gaze duration on pain faces', 'Eye movements provided indices of early (probability and duration of first fixation) and later (total gaze duration) attentional deployment', 'Pain faces', 'fixation duration bias towards pain', 'levels of FPE']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",52.0,0.0244327,"A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pilch', 'Affiliation': 'Centre for Health Policy and Management, School of Medicine, Trinity College Dublin, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'OʼHora', 'Affiliation': 'School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': 'Center for Pain Research, School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Caes', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, United Kingdom.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McGuire', 'Affiliation': 'School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Kainz', 'Affiliation': 'Department of Psychology, Faculty of Natural Sciences, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Vervoort', 'Affiliation': 'Department of Experimental and Clinical Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium.'}]",Pain,['10.1097/j.pain.0000000000001827']
640,32186030,Effect of acupuncture therapies combined with usual medical care on knee osteoarthritis.,"OBJECTIVE


To observe the effect of acupuncture or electroacupuncture (EA) combined with usual medical care for treating knee osteoarthritis (KOA) .
METHODS


A total of 90 patients with KOA were randomly allocated to 3 groups: usual care group (UC group, n = 30) was treated by pharmacological treatment of non-steroidal anti-inflammatory drugs (NSAIDs) and drugs for activating blood circulation (Ds-ABC), acupuncture (AP) combined with usual care group (UC group) (AP + UC group, n = 30) and EA combined with UC group (EA + UC group, n = 30). The primary outcome measurements included pain visual analogue scale/score (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index) and its subscales. Secondary outcome measurement was Assessment of Quality of Life instrument version of the 36-item Short Form Health Survey (AQoL-SF36).
RESULTS


By the end of the 1st week, AP + UC group and EA + UC group exhibited statistically significant improvements in primary outcome measures, except for WOMAC stiffness, compared with the UC group (P < 0.05). Moreover, the energy/fatigue domain of AQoL-SF36 in the AP + UC group showed better results than UC group (P < 0.05). By the end of the 2nd week, all the primary outcome measures revealed that either the AP + UC or EA + UC group demonstrating remarkable advantages compared with the UC group (P < 0.05). The social functioning and general health domains of AQoL-SF36 in the two acupuncture-intervention groups were improved significantly than UC group (P < 0.05). We also found the energy/fatigue and emotional wellbeing domains of AQoL-SF36 in the EA + UC group demonstrated better results than UC group (P < 0.05).
CONCLUSION


AP or EA combined with usual care is more effective than usual care alone for the treatment of KOA, the intervention of electric current in the process of acupuncture may improve more domains of AQoL-SF36 in KOA patients.",2019,The social functioning and general health domains of AQoL-SF36 in the two acupuncture-intervention groups were improved significantly than UC group (P < 0.05).,"['90 patients with KOA', 'knee osteoarthritis', 'KOA patients']","['usual care group (UC group, n = 30) was treated by pharmacological treatment of non-steroidal anti-inflammatory drugs (NSAIDs) and drugs for activating blood circulation (Ds-ABC), acupuncture (AP) combined with usual care group (UC group) (AP + UC group, n = 30) and EA combined with UC group (EA + UC', 'acupuncture or electroacupuncture (EA) combined with usual medical care', 'acupuncture therapies combined with usual medical care']","['energy/fatigue and emotional wellbeing domains of AQoL-SF36', 'pain visual analogue scale/score (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index) and its subscales', 'social functioning and general health domains of AQoL-SF36', 'energy/fatigue domain of AQoL-SF36', 'WOMAC stiffness', 'Quality of Life instrument version of the 36-item Short Form Health Survey (AQoL-SF36']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0005775', 'cui_str': 'Blood Circulation'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",90.0,0.0458715,The social functioning and general health domains of AQoL-SF36 in the two acupuncture-intervention groups were improved significantly than UC group (P < 0.05).,"[{'ForeName': 'Lele', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Haixin', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
641,31688884,Effect of Caspofungin vs Fluconazole Prophylaxis on Invasive Fungal Disease Among Children and Young Adults With Acute Myeloid Leukemia: A Randomized Clinical Trial.,"Importance


Children, adolescents, and young adults with acute myeloid leukemia are at high risk of life-threatening invasive fungal disease with both yeasts and molds.
Objective


To compare the efficacy of caspofungin vs fluconazole prophylaxis against proven or probable invasive fungal disease and invasive aspergillosis during neutropenia following acute myeloid leukemia chemotherapy.
Design, Setting, and Participants


This multicenter, randomized, open-label, clinical trial enrolled patients aged 3 months to 30 years with newly diagnosed de novo, relapsed, or secondary acute myeloid leukemia being treated at 115 US and Canadian institutions (April 2011-November 2016; last follow-up June 30, 2018).
Interventions


Participants were randomly assigned during the first chemotherapy cycle to prophylaxis with caspofungin (n = 257) or fluconazole (n = 260). Prophylaxis was administered during the neutropenic period following each chemotherapy cycle.
Main Outcomes and Measures


The primary outcome was proven or probable invasive fungal disease as adjudicated by blinded central review. Secondary outcomes were invasive aspergillosis, empirical antifungal therapy, and overall survival.
Results


The second interim efficacy analysis and an unplanned futility analysis based on 394 patients appeared to have suggested futility, so the study was closed to accrual. Among the 517 participants who were randomized (median age, 9 years [range, 0-26 years]; 44% female), 508 (98%) completed the trial. The 23 proven or probable invasive fungal disease events (6 caspofungin vs 17 fluconazole) included 14 molds, 7 yeasts, and 2 fungi not further categorized. The 5-month cumulative incidence of proven or probable invasive fungal disease was 3.1% (95% CI, 1.3%-7.0%) in the caspofungin group vs 7.2% (95% CI, 4.4%-11.8%) in the fluconazole group (overall P = .03 by log-rank test) and for cumulative incidence of proven or probable invasive aspergillosis was 0.5% (95% CI, 0.1%-3.5%) with caspofungin vs 3.1% (95% CI, 1.4%-6.9%) with fluconazole (overall P = .046 by log-rank test). No statistically significant differences in empirical antifungal therapy (71.9% caspofungin vs 69.5% fluconazole, overall P = .78 by log-rank test) or 2-year overall survival (68.8% caspofungin vs 70.8% fluconazole, overall P = .66 by log-rank test) were observed. The most common toxicities were hypokalemia (22 caspofungin vs 13 fluconazole), respiratory failure (6 caspofungin vs 9 fluconazole), and elevated alanine transaminase (4 caspofungin vs 8 fluconazole).
Conclusions and Relevance


Among children, adolescents, and young adults with acute myeloid leukemia, prophylaxis with caspofungin compared with fluconazole resulted in significantly lower incidence of invasive fungal disease. The findings suggest that caspofungin may be considered for prophylaxis against invasive fungal disease, although study interpretation is limited by early termination due to an unplanned interim analysis that appeared to have suggested futility.
Trial Registration


ClinicalTrials.gov Identifier: NCT01307579.",2019,"No statistically significant differences in empirical antifungal therapy (71.9% caspofungin vs 69.5% fluconazole, overall P = .78 by log-rank test) or 2-year overall survival (68.8% caspofungin vs 70.8% fluconazole, overall P = .66 by log-rank test) were observed.","['children, adolescents, and young adults with acute myeloid leukemia, prophylaxis with caspofungin compared with', 'probable invasive fungal disease and invasive aspergillosis during neutropenia following acute myeloid leukemia chemotherapy', 'Children and Young Adults', '394 patients', 'With Acute Myeloid Leukemia', '517 participants who were randomized (median age, 9 years [range, 0-26 years]; 44% female), 508 (98%) completed the trial', '23 proven or probable invasive fungal disease events (6 caspofungin vs 17 fluconazole) included 14 molds, 7 yeasts, and 2 fungi not further categorized', 'patients aged 3 months to 30 years with newly diagnosed de novo, relapsed, or secondary acute myeloid leukemia being treated at 115 US and Canadian institutions (April 2011-November 2016; last follow-up June 30, 2018', 'Importance\n\n\nChildren, adolescents, and young adults with acute myeloid leukemia']","['Caspofungin vs Fluconazole Prophylaxis', 'chemotherapy cycle to prophylaxis with caspofungin (n\u2009=\u2009257) or fluconazole', 'fluconazole', 'caspofungin vs fluconazole prophylaxis']","['5-month cumulative incidence of proven or probable invasive fungal disease', 'invasive aspergillosis, empirical antifungal therapy, and overall survival', 'invasive fungal disease', 'empirical antifungal therapy', '2-year overall survival', 'Invasive Fungal Disease', 'respiratory failure', 'cumulative incidence of proven or probable invasive aspergillosis', 'elevated alanine transaminase', 'proven or probable invasive fungal disease']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0238013', 'cui_str': 'Invasive aspergillosis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0369241', 'cui_str': 'Molds'}, {'cui': 'C0043393', 'cui_str': 'Yeasts'}, {'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0238013', 'cui_str': 'Invasive aspergillosis'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]",517.0,0.189183,"No statistically significant differences in empirical antifungal therapy (71.9% caspofungin vs 69.5% fluconazole, overall P = .78 by log-rank test) or 2-year overall survival (68.8% caspofungin vs 70.8% fluconazole, overall P = .66 by log-rank test) were observed.","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Fisher', 'Affiliation': ""Division of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Theoklis', 'Initials': 'T', 'LastName': 'Zaoutis', 'Affiliation': ""Division of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Dvorak', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Bone Marrow Transplant, University of California San Francisco.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nieder', 'Affiliation': 'Division of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Zerr', 'Affiliation': ""Division of Pediatric Infectious Diseases, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': 'University of Florida College of Medicine, Gainesville.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Callahan', 'Affiliation': ""Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Doojduen', 'Initials': 'D', 'LastName': 'Villaluna', 'Affiliation': ""Children's Oncology Group, Monrovia, California.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, City of Hope, Duarte, California.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Esbenshade', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'Division of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Wiley', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Sinai Hospital of Baltimore, Baltimore, Maryland.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'Division of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.'}]",JAMA,['10.1001/jama.2019.15702']
642,30737610,Application of an HIV Prevention Cascade to Identify Gaps in Increasing Coverage of Voluntary Medical Male Circumcision Services in 42 Rural Zambian Communities.,"Increased coverage of voluntary medical male circumcision (VMMC) is needed in countries with high HIV prevalence. We applied an HIV-prevention cascade to identify gaps in male circumcision coverage in Zambia. We used survey data collected in 2013 and 2014/15 to describe circumcision coverage at each time-point, and prevalence of variables related to demand for and supply of VMMC. We explored whether circumcision coverage in 2014/15 was associated with demand and supply among uncircumcised men in 2013. Results show that circumcision coverage was 11.5% in 2013 and 18.0% in 2014/15. Levels of having heard of circumcision and agreeing with prevention benefits was similar at both time-points (79.8% vs 83.2%, and 49.7% vs 50.7%, respectively). In 2013, 39.3% of men perceived services to be available compared to 54.7% in 2014/15. Levels of having heard of circumcision in 2013 was correlated with and higher perceived service availability associated with coverage in 2014/15. VMMC coverage was low in these study sites. Knowledge of prevention tools and of service availability are necessary to increase coverage but alone are insufficient.",2019,Levels of having heard of circumcision in 2013 was correlated with and higher perceived service availability associated with coverage in 2014/15.,"['male circumcision coverage in Zambia', '42 Rural Zambian Communities', 'uncircumcised men in 2013']",[],"['VMMC coverage', 'Levels of\xa0having heard of circumcision', 'Levels of having heard of circumcision and agreeing with prevention benefits', 'circumcision coverage']","[{'cui': 'C0008819', 'cui_str': 'Male Circumcision'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0282021', 'cui_str': 'Uncircumcised'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",,0.0214404,Levels of having heard of circumcision in 2013 was correlated with and higher perceived service availability associated with coverage in 2014/15.,"[{'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Clinical Research Department, Infectious and Tropical Diseases, The London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Bernadette.hensen@lshtm.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fearon', 'Affiliation': 'Public Health, Environments and Society, Public Health and Policy, The London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Infectious Disease Epidemiology, Epidemiology and Population Health, The London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Lewis', 'Affiliation': 'Infectious Disease Epidemiology, Epidemiology and Population Health, The London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'Infectious Disease Epidemiology, Epidemiology and Population Health, The London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tembo', 'Affiliation': 'Zambart, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Namwinga', 'Initials': 'N', 'LastName': 'Chintu', 'Affiliation': 'Society for Family Health, Lusaka, Zambia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Clinical Research Department, Infectious and Tropical Diseases, The London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hargreaves', 'Affiliation': 'Public Health, Environments and Society, Public Health and Policy, The London School of Hygiene and Tropical Medicine, London, UK.'}]",AIDS and behavior,['10.1007/s10461-019-02407-w']
643,30747340,Cognitive Behavioral Therapy for Treatment-Related Fatigue in Chronic Myeloid Leukemia Patients on Tyrosine Kinase Inhibitors: A Mixed-Method Study.,"Treatment-related fatigue significantly limits quality of life among chronic myeloid leukemia (CML) patients receiving tyrosine kinase inhibitors (TKIs), yet no interventions to reduce this symptom have been studied. We examined preliminary feasibility and efficacy of cognitive behavioral therapy for TKI treatment-related fatigue in patients with CML. We used a mixed methods convergent design and collected quantitative data through randomized single-case experiments. We included CML patients receiving TKIs and reporting severe fatigue. Within each participant, we compared CBT to a no-treatment baseline period. Fatigue severity was measured weekly with the Checklist Individual Strength. Fatigue scores were subjected to visual analyses and randomization tests for single-case experimental designs. We conducted qualitative interviews after study participation and focused on feasibility and efficacy of CBT. Visual inspection of line graphs indicated downward trends in the expected direction for fatigue in two of the four participants. The test statistics showed a decrease in fatigue severity for all participants but randomization tests did not reach statistical significance (overall p = 0.18). Participants reported qualitative improvements in level of functioning and coping with fatigue. CBT was considered feasible and acceptable for severely fatigued CML patients. Our study provided preliminary evidence for the feasibility and acceptability of CBT for severely fatigued CML patients receiving targeted therapy. We recommend further efficacy testing of this promising intervention in a pilot randomized controlled trial.",2019,The test statistics showed a decrease in fatigue severity for all participants but randomization tests did not reach statistical significance (overall p = 0.18).,"['severely fatigued CML patients receiving targeted therapy', 'patients with CML', 'Chronic Myeloid Leukemia Patients on Tyrosine Kinase Inhibitors', 'chronic myeloid leukemia (CML) patients receiving', 'CML patients receiving TKIs and reporting severe fatigue']","['Cognitive Behavioral Therapy', 'cognitive behavioral therapy', 'tyrosine kinase inhibitors (TKIs', 'CBT']","['fatigue severity', 'Fatigue severity', 'level of functioning and coping with fatigue', 'Fatigue scores']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",4.0,0.0473514,The test statistics showed a decrease in fatigue severity for all participants but randomization tests did not reach statistical significance (overall p = 0.18).,"[{'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Poort', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Onghena', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven-University of Leuven, Tiensestraat 102, 3000, Leuven, Belgium.'}, {'ForeName': 'Harriët J G', 'Initials': 'HJG', 'LastName': 'Abrahams', 'Affiliation': 'Department of Medical Psychology, Amsterdam Public Health Research Institute, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands.'}, {'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 Magnolia Drive MRC-SCM, Tampa, FL, 33612, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Nicole M A', 'Initials': 'NMA', 'LastName': 'Blijlevens', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam Public Health Research Institute, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands. Hans.Knoop@amc.uva.nl.'}]",Journal of clinical psychology in medical settings,['10.1007/s10880-019-09607-5']
644,32148744,"Effects of Video-Game Based Therapy on Balance, Postural Control, Functionality, and Quality of Life of Patients with Subacute Stroke: A Randomized Controlled Trial.","Purpose


To determine the effects of a structured protocol using commercial video games on balance, postural control, functionality, quality of life, and level of motivation in patients with subacute stroke.
Methods


A randomized controlled trial was conducted. A control group ( n  = 25) received eight weeks of conventional rehabilitation consisting of five weekly sessions based on an approach for task-oriented motor training. The experimental group ( n  = 25) received eight weeks of conventional rehabilitation consisting of five weekly sessions based on an approach for task-oriented motor training. The experimental group (.
Results


In the between-group comparison, statistically significant differences were observed in the Modified Rankin scores ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index (.
Conclusion


A protocol of semi-immersive video-game based therapy, combined with conventional therapy, may be effective for improving balance, functionality, quality of life, and motivation in patients with subacute stroke. This trial is registered with NCT03528395.",2020,"The experimental group (.
Results


In the between-group comparison, statistically significant differences were observed in the Modified Rankin scores ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index (.
","['Patients with Subacute Stroke', 'patients with subacute stroke']","['Video-Game Based Therapy', 'conventional rehabilitation consisting of five weekly sessions based on an approach for task-oriented motor training', 'structured protocol using commercial video games']","['balance, postural control, functionality, quality of life, and level of motivation', 'balance, functionality, quality of life, and motivation', 'Balance, Postural Control, Functionality, and Quality of Life', 'Barthel Index', 'Modified Rankin scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}]",,0.0583185,"The experimental group (.
Results


In the between-group comparison, statistically significant differences were observed in the Modified Rankin scores ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index ( p  < 0.01), the Barthel Index (.
","[{'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Cano-Mañas', 'Affiliation': 'Escuela Internacional de Doctorado, Universidad Rey Juan Carlos (URJC), Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Collado-Vázquez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Universidad Rey Juan Carlos (URJC), Alcorcón, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodríguez Hernández', 'Affiliation': 'Hospital La Fuenfría (Servicio Madrileño de Salud), Cercedilla, Madrid, Spain.'}, {'ForeName': 'Antonio Jesús', 'Initials': 'AJ', 'LastName': 'Muñoz Villena', 'Affiliation': 'Facultad de Formación del Profesorado, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Universidad Rey Juan Carlos (URJC), Alcorcón, Madrid, Spain.'}]",Journal of healthcare engineering,['10.1155/2020/5480315']
645,30877684,Incidence and Risk Factors for Hospital Readmission or Unexpected Visits in Women Undergoing Unscheduled Cesarean Delivery.,"OBJECTIVE


Hospital readmissions are increasingly tracked and assessed for value-based compensation. Our objective was to determine the incidence and risk factors associated with post-cesarean delivery (CD) readmissions or unexpected visits, defined as unexpected office or emergency room visits.
STUDY DESIGN


This is a secondary analysis of a multicenter randomized controlled trial of adjunctive azithromycin prophylaxis for CD performed in laboring patients with viable pregnancies. Patients were followed up to 6 weeks postpartum. Our primary outcome was a composite of hospital readmission or unexpected visit, defined as unscheduled clinic or emergency department visits. Data of hospital readmissions, unexpected visits, and their reasons were collected. Demographics, antepartum, intrapartum, and postpartum risk factors were evaluated in bivariate analyses and multivariable logistic regression modeling.
RESULTS


A total of 1,019 women were randomized to azithromycin and 994 to placebo. The prevalence of readmission or unexpected visit was 10.2% (95% confidence interval [CI]: 8.9-11.6), with rates of 3.8% (95% CI: 3.0-4.7%) hospital readmissions, 6.9% (95% CI: 5.8-8.0%) emergency room visits, and 4.2% (95% CI: 3.4-5.2%) unexpected clinic visits. The most common causes were infectious disease and hypertensive disorder. Women with readmissions or unexpected visits were more likely to be obese and diabetic, as well as experience longer length of ruptured membranes, intrauterine pressure catheter placement, and postpartum fevers. On multivariable analysis, diabetes (adjusted odds ratio [aOR]: 1.6, 95% CI: 1.1-2.4), prolonged ruptured membranes (aOR: 1.9, 95% CI: 1.3-2.8), and postpartum fevers (aOR: 4.6, 95% CI: 3.0-7.0) were significantly positively associated with readmission or unscheduled visit, while azithromycin was a protective (aOR: 0.6, 95% CI: 0.5-0.9).
CONCLUSION


Women who had postpartum fever were at especially high risk for readmission or unexpected visits. Diabetes, prolonged ruptured membranes, and postpartum fevers were significantly associated with the adverse outcome, and azithromycin was associated with lower rates of readmission and unexpected visits.",2019,"On multivariable analysis, diabetes (adjusted odds ratio [aOR]: 1.6, 95% CI: 1.1-2.4), prolonged ruptured membranes (aOR: 1.9, 95% CI: 1.3-2.8), and postpartum fevers (aOR: 4.6, 95% CI: 3.0-7.0) were significantly positively associated with readmission or unscheduled visit, while azithromycin was a protective (aOR: 0.6, 95% CI: 0.5-0.9).
","['A total of 1,019 women', 'laboring patients with viable pregnancies', 'Women who had postpartum fever were at especially high risk for readmission or unexpected visits', 'Women Undergoing Unscheduled Cesarean Delivery']","['azithromycin', 'adjunctive azithromycin prophylaxis', 'placebo']","['postpartum fevers', 'hospital readmissions', 'prevalence of readmission or unexpected visit', 'Demographics, antepartum, intrapartum, and postpartum risk factors', 'composite of hospital readmission or unexpected visit, defined as unscheduled clinic or emergency department visits', 'readmission or unscheduled visit', 'prolonged ruptured membranes']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy (finding)'}, {'cui': 'C1331543', 'cui_str': 'Puerperal pyrexia (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1331543', 'cui_str': 'Puerperal pyrexia (disorder)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456336', 'cui_str': 'Antepartum (qualifier value)'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C1171170', 'cui_str': 'Postpartum risk'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]",1019.0,0.161396,"On multivariable analysis, diabetes (adjusted odds ratio [aOR]: 1.6, 95% CI: 1.1-2.4), prolonged ruptured membranes (aOR: 1.9, 95% CI: 1.3-2.8), and postpartum fevers (aOR: 4.6, 95% CI: 3.0-7.0) were significantly positively associated with readmission or unscheduled visit, while azithromycin was a protective (aOR: 0.6, 95% CI: 0.5-0.9).
","[{'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'La Rosa', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jauk', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Boggess', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Oshner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Erin A S', 'Initials': 'EAS', 'LastName': 'Clark', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Esplin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Cleary', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Kellet', 'Initials': 'K', 'LastName': 'Letson', 'Affiliation': 'Department of Obstetrics and Gynecology, Mission Hospital, Asheville, North Carolina.'}, {'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Owens', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Mississippi at Jackson, Jackson, Mississippi.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Blackwell', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Houston at Houston, Houston, Texas.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Andrews', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1683391']
646,31608930,Ghrelin Does Not Directly Stimulate Secretion of Glucagon-like Peptide-1.,"CONTEXT


The gastrointestinal hormone ghrelin stimulates growth hormone secretion and appetite, but recent studies indicate that ghrelin also stimulates the secretion of the appetite-inhibiting and insulinotropic hormone glucagon-like peptide-1 (GLP-1).
OBJECTIVE


To investigate the putative effect of ghrelin on GLP-1 secretion in vivo and in vitro.
SUBJECTS AND METHODS


A randomized placebo-controlled crossover study was performed in eight hypopituitary subjects. Ghrelin or saline was infused intravenously (1 pmol/min × kg) after collection of baseline sample (0 min), and blood was subsequently collected at time 30, 60, 90, and 120 minutes. Mouse small intestine was perfused (n = 6) and GLP-1 output from perfused mouse small intestine was investigated in response to vascular ghrelin administration in the presence and absence of a simultaneous luminal glucose stimulus. Ghrelin receptor expression was quantified in human (n = 11) and mouse L-cells (n = 3) by RNA sequencing and RT-qPCR, respectively.
RESULTS


Ghrelin did not affect GLP-1 secretion in humans (area under the curve [AUC; 0-120 min]: ghrelin infusion = 1.37 ± 0.05 min × nmol vs. saline infusion = 1.40 ± 0.06 min × nmol [P = 0.63]), but induced peripheral insulin resistance. Likewise, ghrelin did not stimulate GLP-1 secretion from the perfused mouse small intestine model (mean outputs during baseline/ghrelin infusion = 19.3 ± 1.6/25.5 ± 2.0 fmol/min, n = 6, P = 0.16), whereas glucose-dependent insulinotropic polypeptide administration, used as a positive control, doubled GLP-1 secretion (P < 0.001). Intraluminal glucose increased GLP-1 secretion by 4-fold (P < 0.001), which was not potentiated by ghrelin. Finally, gene expression of the ghrelin receptor was undetectable in mouse L-cells and marginal in human L-cells.
CONCLUSIONS


Ghrelin does not interact directly with the L-cell and does not directly affect GLP-1 secretion.",2020,Intra-luminal glucose increased GLP-1 secretion by 4-fold (P<0.001) which was not potentiated by ghrelin.,['eight hypopituitary subjects'],"['placebo', 'Ghrelin or saline']","['Ghrelin receptor expression', 'GLP-1 secretion', 'peripheral insulin resistance']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",,0.090868,Intra-luminal glucose increased GLP-1 secretion by 4-fold (P<0.001) which was not potentiated by ghrelin.,"[{'ForeName': 'Sara Lind', 'Initials': 'SL', 'LastName': 'Jepsen', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Esben Thyssen', 'Initials': 'ET', 'LastName': 'Vestergaard', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Larraufie', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, UK.""}, {'ForeName': 'Fiona Mary', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, UK.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': ""Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, UK.""}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Medical Research Laboratories Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rune Ehrenreich', 'Initials': 'RE', 'LastName': 'Kuhre', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz046']
647,32180212,Role of Sexual Intercourse after Shockwave Lithotripsy for Distal Ureteral Stones: A Randomized Controlled Trial.,"PURPOSE


To explore whether sexual intercourse is beneficial to the clinical outcome of SWL for ureteral calculi of 7-15 mm in the distal ureter.
MATERIALS AND METHODS


Between March 2016 and January 2017, 225 patents with a stone (7-15 mm) in distal ureter were randomly divided into three groups after SWL: Group 1 was asked to have sexual intercourse at least three times a week, Group 2 was administered tamsulosin 0.4 mg/d and Group 3 was received standard therapy alone and served as the controls. Stone free rate, time to stone expulsion, pain score at admission, number of hospital visits for pain and steinstrasse were recorded in 2 weeks.
RESULTS


70 patients in Group 1, 71 patients in Group 2 and 68 patients in Group 3 were enrolled to the study. At the end of the first week and the second week, the stone free rates for Group 1 (68.6%, 80.0%) and Group 2 (69.0%, 81.7%) were approximately the same, but were significantly higher than Group 3 (50.0%, 63.2%) (P = .031, P = .022). The VAS scores of Groups 1 and 2 were slightly higher than those of Group 3 (P = .233). The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015). At the end of the second week, the incidence of steinstrasse in Groups 1 and 2 was significantly lower (2.9%, 2.8% vs 11.8%) (P = .034).
CONCLUSION


At least three sexual intercourses per week after SWL can effectively improve the stone free rate, reduce the formation of steinstrasse and relieve renal colic. It provides a choice for urologists in the SWL treatment of lower ureteral calculi.",2020,The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015).,"['Distal Ureteral Stones', 'Between March 2016 and January 2017', '70 patients in Group 1, 71 patients in Group 2 and 68 patients in Group 3 were enrolled to the study', '225 patents with a stone (7-15 mm) in distal ureter']","['tamsulosin 0.4 mg/d and Group 3 was received standard therapy alone and served as the controls', 'Shockwave Lithotripsy']","['incidence of steinstrasse', 'VAS scores', 'stone free rates', 'formation of steinstrasse and relieve renal colic', 'Sexual Intercourse', 'Stone free rate, time to stone expulsion, pain score at admission, number of hospital visits for pain and steinstrasse', 'visited the emergency room for pain']","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0403718', 'cui_str': 'Steinstrasse (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",,0.0189539,The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015).,"[{'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China. lichen0612@163.com.""}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Hua', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}]",Urology journal,['10.22037/uj.v0i0.5400']
648,31926321,"The chronic pain skills study: Protocol for a randomized controlled trial comparing hypnosis, mindfulness meditation and pain education in Veterans.","OBJECTIVES


To describe the protocol of a randomized controlled trial to evaluate the effectiveness and mechanisms of three behavioral interventions.
METHODS


Participants will include up to 343 Veterans with chronic pain due to a broad range of etiologies, randomly assigned to one of three 8-week manualized in-person group treatments: (1) Hypnosis (HYP), (2) Mindfulness Meditation (MM), or (3) Education Control (EDU).
PROJECTED OUTCOMES


The primary aim of the study is to compare the effectiveness of HYP and MM to EDU on average pain intensity measured pre- and post-treatment. Additional study aims will explore the effectiveness of HYP and MM compared to EDU on secondary outcomes (i.e., pain interference, sleep, depression, anxiety and PTSD), and the maintenance of effects at 3- and 6-months post-treatment. Participants will have electroencephalogram (EEG) assessments at pre- and post-treatment to determine if the power of specific brain oscillations moderate the effectiveness of HYP and MM (Study Aim 2) and examine brain oscillations as possible mediators of treatment effects (exploratory aim). Additional planned exploratory analyses will be performed to identify possible treatment mediators (i.e., pain acceptance, catastrophizing, mindfulness) and moderators (e.g., hypnotizability, treatment expectations, pain type, cognitive function).
SETTING


The study treatments will be administered at a large Veterans Affairs Medical Center in the northwest United States. The treatments will be integrated within clinical infrastructure and delivered by licensed and credentialed health care professionals.",2020,"8-week manualized in-person group treatments: (1) Hypnosis (HYP), (2) Mindfulness Meditation (MM), or (3) Education Control (EDU).
","['veterans', 'large Veterans Affairs Medical Center in the northwest United States', 'Participants will include up to 343 Veterans with chronic pain due to a broad range of etiologies, randomly assigned to one of three']","['hypnosis, mindfulness meditation and pain education', '8-week manualized in-person group treatments: (1) Hypnosis (HYP), (2) Mindfulness Meditation (MM), or (3) Education Control (EDU', 'HYP and MM', 'HYP and MM to EDU']","['electroencephalogram (EEG) assessments', 'secondary outcomes (i.e., pain interference, sleep quality, depression and anxiety']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",343.0,0.121871,"8-week manualized in-person group treatments: (1) Hypnosis (HYP), (2) Mindfulness Meditation (MM), or (3) Education Control (EDU).
","[{'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Williams', 'Affiliation': 'VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America; University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America. Electronic address: Rhonda.Williams1@va.gov.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Day', 'Affiliation': 'The University of Queensland, School of Psychology, Faculty of Health & Behavioral Sciences, St. Lucia Campus, Brisbane, QLD 4072, Australia.'}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Turner', 'Affiliation': 'VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America; University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Hakimian', 'Affiliation': 'University of Washington School of Medicine, Department of Neurology, Harborview Medical Center, 325 Ninth Ave, Box 359745, Seattle, WA 98104, United States of America.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gertz', 'Affiliation': 'University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Ciol', 'Affiliation': 'University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'McCall', 'Affiliation': 'VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Kincaid', 'Affiliation': 'VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Pettet', 'Affiliation': 'University of Washington, Integrated Brain Imaging Center, Department of Radiology, 1959 NE Pacific St., Box 357115, Seattle, WA 98195, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Patterson', 'Affiliation': 'University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Suri', 'Affiliation': 'VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America; University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105935']
649,32171064,"Predictive value of blood eosinophils and exhaled nitric oxide in adults with mild asthma: a prespecified subgroup analysis of an open-label, parallel-group, randomised controlled trial.","BACKGROUND


Whether blood eosinophil counts and exhaled nitric oxide (FeNO) are associated with important outcomes in mild asthma is unclear. In this prespecified subgroup analysis of a previously published open-label clinical trial, we aimed to assess associations between blood eosinophil counts and FeNO with outcomes and response to asthma treatment.
METHODS


In the previously reported 52-week, open-label, randomised controlled trial, people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia. Eligible participants were randomly assigned (1:1:1, stratified by country), to receive inhalers to take as-needed salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler). The primary outcome was the annual rates of asthma exacerbations per patient, and in this prespecified subgroup analysis, we assessed whether annual exacerbation rates in each treatment group were significantly different depending on levels of blood eosinophil count, FeNO, or a composite score of both. Analyses were done for patients with available biomarker measurements The study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000999538.
FINDINGS


675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO. Of the patients who received as-needed salbutamol, the proportion of patients having a severe exacerbation increased progressively with increasing blood eosinophil count (two [4%] of 49 participants with <0·15 × 10 9 /L, six [6%] of 93 with 0·15 to <0·3 × 10 9 /L, and 15 [19%] of 77 with ≥0·3 × 10 9 /L; p=0·014). There were no significant interactions between blood eosinophil count or FeNO level and the effect of as-needed budesonide-formoterol compared with as-needed salbutamol for either exacerbations or severe exacerbations. However, there were significant interactions between blood eosinophil count subgroups and the effect of maintenance budesonide plus as-needed salbutamol compared with as-needed salbutamol, both for exacerbations (p=0·0006) and severe exacerbations (p=0·0007). Maintenance budesonide plus as-needed salbutamol was more effective than as-needed salbutamol in patients with blood eosinophil counts of 0·3 × 10 9 /L or more, both for exacerbations (rate ratio 0·13 [95% CI 0·05-0·33]) and severe exacerbations (risk odds ratio 0·11 [0·03-0·45]). This difference was not seen for blood eosinophil counts of less than 0·15 × 10 9 /L (1·15 [0·51-1·28] for exacerbations and 5·72 [0·97-33·60] for severe exacerbations). There was no consistent interaction between treatment response and FeNO or the composite score.
INTERPRETATION


In patients with mild asthma, the effects of as-needed budesonide-formoterol on exacerbations are independent of biomarker profile, whereas the benefits of maintenance inhaled budesonide are greater in patients with high blood eosinophil counts than in patients with low counts.
FUNDING


AstraZeneca, Health Research Council of New Zealand.",2020,This difference was not seen for blood eosinophil counts of less than 0·15 ,"['10', 'patients with blood eosinophil counts of 0·3', '675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO', 'people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia', '0·13', 'patients with available biomarker measurements', '10 9', '49 participants with <0·15', 'patients with mild asthma', 'adults with mild asthma', 'Eligible participants']","['budesonide-formoterol', 'blood eosinophils and exhaled nitric oxide', 'salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler']","['blood eosinophil count', 'annual exacerbation rates', 'blood eosinophil counts', 'severe exacerbations', 'annual rates of asthma exacerbations', 'exacerbations (rate ratio', 'blood eosinophil count or FeNO level', 'levels of blood eosinophil count, FeNO, or a composite score of both']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",675.0,0.625881,This difference was not seen for blood eosinophil counts of less than 0·15 ,"[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Oxford Respiratory National Institute for Health Research Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ebmeier', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand; Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Houghton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Oldfield', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30053-9']
650,30917121,Feasibility of conducting HIV combination prevention interventions in fishing communities in Uganda: A pilot cluster randomised trial.,"OBJECTIVE


We assessed feasibility of an HIV-combination-prevention trial among fishing communities in Uganda.
DESIGN


Cluster randomised trial in four fishing communities on Lake Victoria, Uganda. Two intervention communities received a combination-prevention-package (behaviour change communication, condom promotion, HIV testing, voluntary male medical circumcision and referral for anti-retroviral therapy if HIV-positive). All four communities received routine government HIV care services.
METHODS


Using household census data we randomly selected a cohort of consenting residents aged ≥18 years. A baseline sero-survey in July 2014 was followed by two repeat surveys in March and December 2015. We measured uptake of HIV prevention methods, loss-to-follow-up and HIV incidence, accounting for multistage survey design.
RESULTS


A total of 862 participants were enrolled and followed for 15 months. Participation was 62% and 74% in the control and intervention arms respectively; Overall loss to follow up (LTFU) was 21.6% and was similar by arm. Self-reported abstinence/faithfulness increased between baseline and endline in both arms from 53% to 73% in the control arm, and 55% to 67% in the intervention arm. Reported condom use throughout the study period was 36% in the intervention arm vs 28% in the control arm; number of male participants reporting circumsicion in both arms from 58% to 79% in the intervention arm, and 39% to 46% in the control arm. Independent baseline predictors of loss-to-follow-up were: being HIV positive, residence in the community for <1 year, younger age, living in an urban area, and being away from the area for >1 month/year.
CONCLUSIONS


Recruitment and retention of participants in longitudinal trials in highly mobile HIV fishing communities is challenging. Future research should investigate modes for locating and retaining participants, and delivery of HIV-combination prevention.",2019,"Self-reported abstinence/faithfulness increased between baseline and endline in both arms from 53% to 73% in the control arm, and 55% to 67% in the intervention arm.","['consenting residents aged ≥18 years', 'Using household census data', 'four fishing communities on Lake Victoria, Uganda', '862 participants were enrolled and followed for 15 months', 'fishing communities in Uganda']","['combination-prevention-package (behaviour change communication, condom promotion, HIV testing, voluntary male medical circumcision and referral for anti-retroviral therapy if HIV-positive', 'HIV combination prevention interventions', 'HIV-combination-prevention']","['Self-reported abstinence/faithfulness', 'uptake of HIV prevention methods, loss-to-follow-up and HIV incidence', 'Overall loss to follow up (LTFU']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0007663', 'cui_str': 'Censuses'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",862.0,0.228257,"Self-reported abstinence/faithfulness increased between baseline and endline in both arms from 53% to 73% in the control arm, and 55% to 67% in the intervention arm.","[{'ForeName': 'Monica O', 'Initials': 'MO', 'LastName': 'Kuteesa', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe Uganda.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Abaasa', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe Uganda.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Nash', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London United Kingdom.'}, {'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Nsubuga', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe Uganda.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Newton', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe Uganda.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe Uganda.'}, {'ForeName': 'Anatoli', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'International AIDS Vaccine Initiative, Nairobi, Kenya.'}]",PloS one,['10.1371/journal.pone.0210719']
651,32003822,Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial.,"Importance


Lung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making.
Objective


To examine the effect of a patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU) on decision-making outcomes among smokers.
Design, Setting, and Participants


This randomized clinical trial was conducted using 13 state tobacco quitlines. Current and recent tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017. Data analysis was conducted between May 5, 2017, and September 30, 2018.
Interventions


Participants were randomized to the PDA video Lung Cancer Screening: Is It Right for Me? (n = 259) or to EDU (n = 257).
Main Outcomes and Measures


The primary outcomes were preparation for decision-making and decisional conflict measured at 1 week. Secondary outcomes included knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report.
Results


Of 516 quit line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level. Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001). Feeling informed about their screening choice was reported by 117 of 234 participants (50.0%) using a PDA compared with 66 of 233 participants (28.3%) using EDU (OR, 2.56; 95% CI, 1.72-3.79; P < .001); 159 of 234 participants (68.0%) using a PDA compared with 110 of 232 (47.4%) participants using EDU reported being clear about their values related to the harms and benefits of screening (OR, 2.37; 95% CI, 1.60-3.51; P < .001). Participants using a PDA were more knowledgeable about lung cancer screening than participants using EDU at each follow-up assessment. Intentions to be screened and screening behaviors did not differ between groups.
Conclusions and Relevance


In this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening. Many smokers eligible for lung cancer screening can be reached through tobacco quit lines.
Trial Registration


ClinicalTrials.gov identifier: NCT02286713.",2020,"Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001).","['smokers', 'Who Smoke', 'tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017', 'Persons', '13 state tobacco quitlines', '516 quit', 'line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level']","['PDA video Lung Cancer Screening', 'patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU', 'low-dose computed tomography', 'PDA', 'Patient Decision Aid']","['preparation for decision-making and decisional conflict', 'knowledgeable about lung cancer screening', 'knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C1998726', 'cui_str': 'Is informed (finding)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.247978,"Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Viola B', 'Initials': 'VB', 'LastName': 'Leal', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Kamisha H', 'Initials': 'KH', 'LastName': 'Escoto', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Cantor', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Reginald F', 'Initials': 'RF', 'LastName': 'Munden', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Vance A', 'Initials': 'VA', 'LastName': 'Rabius', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bailey', 'Affiliation': 'North American Quitline Consortium, Phoenix, Arizona.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Housten', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Pamela Graef', 'Initials': 'PG', 'LastName': 'Luckett', 'Affiliation': 'Information & Quality Healthcare Inc, Ridgeland, Mississippi.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Esparza', 'Affiliation': 'Houston Department for Health and Human Services, Houston, Texas.'}, {'ForeName': 'Myrna C', 'Initials': 'MC', 'LastName': 'Godoy', 'Affiliation': 'Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.20362']
652,32006633,Physical activity across the curriculum (PAAC3): Testing the application of technology delivered classroom physical activity breaks.,"Only 43% of children in the U.S., ages 6-11 yrs., meet current physical activity (PA) guidelines. To satisfy the MVPA requirement, schools have begun incorporating MVPA in the form of activity breaks or MVPA academic lessons. We completed two, 3 academic-yr. cluster randomized trials (DK61489, DK85317) called ""Physical Activity Across the Curriculum"" (PAAC) which involved increasing MVPA in the classroom. Across 3-yrs. teachers in PAAC schools delivered ~60 min/wk. (12 min/day) of MVPA. Although short of our MVPA goal (20 min/d), the PAAC approach substantially increased in-school MVPA. Teacher reluctance to devote additional time to develop and integrate PA lessons into their curriculum was the overwhelming barrier to meeting the MVPA goal. Therefore, to reduce barriers to delivery of classroom PA we developed a 3-academic yr. cluster randomized trial (2 yrs. active intervention, 1 yr. follow-up) to compare the effectiveness and sustainability of technology delivered (PAAC-R) and classroom teacher delivered (PAAC-T) activity breaks for increasing classroom MVPA in elementary school students in grades 2 and 3 at baseline who will progress to grades 4-5. NCT registration: NCT03493139.",2020,follow-up) to compare the effectiveness and sustainability of technology delivered (PAAC-R) and classroom teacher delivered (PAAC-T) activity breaks for increasing classroom MVPA in elementary school students in grades 2 and 3 at baseline who will progress to grades 4-5.,['elementary school students in grades 2 and 3 at baseline who will progress to grades 4-5'],"['MVPA', 'Physical activity across the curriculum (PAAC3', 'technology delivered (PAAC-R) and classroom teacher delivered (PAAC-T) activity breaks']",['PAAC approach substantially increased in-school MVPA'],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",2.0,0.0419441,follow-up) to compare the effectiveness and sustainability of technology delivered (PAAC-R) and classroom teacher delivered (PAAC-T) activity breaks for increasing classroom MVPA in elementary school students in grades 2 and 3 at baseline who will progress to grades 4-5.,"[{'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Weight Management, Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Weight Management, Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'J Leon', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': 'Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, KS 66045, USA. Electronic address: jlg@ku.edu.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Weight Management, Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: lptomey@ku.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gorczyca', 'Affiliation': 'Weight Management, Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lee', 'Affiliation': 'Department of Health Policy and Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: rlee2@kumc.edu.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway Street, Lubbock, TX 79409, USA. Electronic address: Todd.D.Little@ttu.edu.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway Street, Lubbock, TX 79409, USA. Electronic address: Jaehoon.Lee@ttu.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Honas', 'Affiliation': 'Weight Management, Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jhonas@ku.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Weight Management, Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105952']
653,32061968,Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial.,"There are adverse effects associated with long-term opioid therapy (LTOT) for chronic pain and clinicians infrequently adhere to opioid treatment guideline recommendations for reducing risk and mitigating opioid-related harms. The primary goal of the Improving the Safety of Opioid Therapy (ISOT) intervention is to reduce harms related to prescription opioids. Secondary aims focus on enhancing the clinician-patient relationship and not having a negative impact on pain-related outcomes (to be examined through a non-inferiority analysis). The study is a cluster-randomized trial and the 44 primary care providers (PCPs) who enrolled were randomized to receive either (1) a two-hour educational workshop about a patient-centered approach to opioid therapy or (2) the educational workshop plus a collaborative care intervention delivered by a nurse care manager (NCM). Patients were assigned to the same condition as their treating PCP. ISOT was based on the chronic care model and includes patient and provider activation, outcomes monitoring, and feedback to the PCP over 12 months. The NCM conducted a baseline assessment with intervention patients, tracked opioid-related behaviors and outcomes, and provided decision support to the opioid-prescribing clinician about opioid safety. Between June 2016 and October 2018, 293 veterans who were prescribed LTOT for chronic pain were enrolled, completed a baseline assessment, and assigned to a treatment condition. Participants were enrolled for 12 months. Masked assessments were conducted with participants at baseline, 6-months, and 12-months. This manuscript describes study rationale, research methods, and baseline findings.",2020,The primary goal of the Improving the Safety of Opioid Therapy (ISOT) intervention is to reduce harms related to prescription opioids.,"['44 primary care providers (PCPs) who enrolled', 'Participants were enrolled for 12\u202fmonths', 'Between June 2016 and October 2018, 293 veterans who were prescribed LTOT for chronic pain']","['opioid therapy (LTOT', 'ISOT', 'Opioid Therapy (ISOT) intervention', 'educational workshop about a patient-centered approach to opioid therapy or (2) the educational workshop plus a collaborative care intervention delivered by a nurse care manager (NCM']",[],"[{'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}]",[],,0.0670923,The primary goal of the Improving the Safety of Opioid Therapy (ISOT) intervention is to reduce harms related to prescription opioids.,"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Morasco', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Psychiatry, Oregon Health & Science University, United States of America. Electronic address: benjamin.morasco@va.gov.'}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Adams', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Maloy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Hooker', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America.'}, {'ForeName': 'Megan O', 'Initials': 'MO', 'LastName': 'Iacocca', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Krebs', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, United States of America; Department of Medicine, Division of General Internal Medicine, University of Minnesota Medical School, United States of America.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Carr', 'Affiliation': 'Primary Care Division, VA Portland Health Care System, United States of America; Department of Medicine, Division of General Internal Medicine, Oregon Health & Science University, United States of America.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Psychiatry, Oregon Health & Science University, United States of America; School of Public Health, Oregon Health & Science University and Portland State University, United States of America.'}, {'ForeName': 'Somnath', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Medicine, Division of General Internal Medicine, Oregon Health & Science University, United States of America; School of Public Health, Oregon Health & Science University and Portland State University, United States of America.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Dobscha', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Psychiatry, Oregon Health & Science University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105957']
654,32068189,Supporting Treatment Adherence Regimens in young children with epilepsy and their families: Trial design and baseline characteristics.,"This article describes the methodology, recruitment, design, and baseline participant characteristics of the Supporting Treatment Adherence Regimens (STAR) trial. STAR is a randomized controlled clinical trial of an education and problem-solving adherence intervention for young children (2-12 years old) with newly diagnosed epilepsy and their families. Using an enrichment design, only participants who demonstrated non-adherence to anti-epileptic drugs within the baseline period were randomized to treatment or control arms. Randomized participants received 8 intervention sessions over a 4-month period and completed three follow-up visits (3, 6, and 12 months following intervention). Two-hundred participants were recruited for the study. The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life. Novel aspects of the trial design (e.g., enrichment, sequential randomization, daily adherence data use), as well as recruitment and retention challenges are discussed.",2020,"The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life.","['participants who demonstrated non-adherence to antiseizure drugs within the baseline period', 'young children (2-12\u202fyears old) with newly diagnosed epilepsy and their families', 'Two-hundred participants were recruited for the study', 'young children with epilepsy and their families']",['education and problem-solving adherence intervention'],"['electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life']","[{'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",200.0,0.162703,"The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life.","[{'ForeName': 'Avani C', 'Initials': 'AC', 'LastName': 'Modi', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229, United States of America; College of Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America. Electronic address: avani.modi@cchmc.org.""}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Glauser', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229, United States of America; College of Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America. Electronic address: Tracy.glauser@cchmc.org.""}, {'ForeName': 'Shanna M', 'Initials': 'SM', 'LastName': 'Guilfoyle', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., Cincinnati, OH 45229, United States of America; College of Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America. Electronic address: shanna.guilfoyle@cchmc.org.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105959']
655,30762320,Which nostril should be used for nasotracheal intubation with Airtraq NT®: the right or left? A randomized clinical trial,"Background/aim


Nasotracheal Airtraq is specifically designed to improve the glottis view and ease the nasotracheal intubation process in normal and difficult cases.
Materials and methods


After  Ethics  committee  approval,  we  decided  to  enroll  40  patients  with  an  ASA  physical  status  of  I  or  II,  between 18 and 70 years of age undergoing elective maxillofascial, oral, and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. Patients were randomized into the right and left nostril groups.
Results


Demographic  and  airway  characteristics  were  similar  among  the  groups.  Nasotracheal  intubation  through  the  right  nostril  was shorter than that of the left nostril during nasotracheal intubation with the Airtraq NT (P < 0.001). 90° counterclockwise rotation of the tip of the tube was needed for directing the tube into the vocal cords in both right and left nostril groups (72% vs 88%). External laryngeal  pressure  and  head  flexion  maneuvers  can  ease  the  intubation  from  the  left  nostril  (P  <  0.001  vs  P  =  0.03).  Cuff  inflation  maneuver also can be helpful in some cases. We did not need any operator change or Magill forceps for any of the patients.
Conclusion


Nasotracheal intubation via the right nostril can be safely and quickly performed with the Airtraq NT without the need of Magill forceps. We recommend the use of the 90° counterclockwise rotation, external laryngeal pressure, and head flexion maneuvers to direct the tube into the vocal cords first. On the other hand, cuff inflation maneuver must also be kept in mind.",2019,the  right  nostril  was shorter than that of the left nostril during nasotracheal intubation with the Airtraq NT (P < 0.001).,"['40  patients  with  an  ASA  physical  status  of  I  or  II,  between 18 and 70 years of age undergoing']","['elective maxillofascial, oral, and double chin surgery to determine which nostril', 'Nasotracheal  intubation  through', '90° counterclockwise rotation, external laryngeal pressure, and head flexion maneuvers to direct the tube into the vocal cords first', 'nasotracheal intubation with Airtraq NT®']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0595944', 'cui_str': 'Structure of anterior naris'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}]",[],40.0,0.0453654,the  right  nostril  was shorter than that of the left nostril during nasotracheal intubation with the Airtraq NT (P < 0.001).,"[{'ForeName': 'Zehra İpek', 'Initials': 'Zİ', 'LastName': 'Arslan', 'Affiliation': ''}, {'ForeName': 'Neşe', 'Initials': 'N', 'LastName': 'Türkyılmaz', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-1803-177']
656,32160422,"Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial.","OBJECTIVE


Alcohol use disorder (AUD) is a common comorbidity of schizophrenia. No effective pharmacologic treatment is available for both disorders to date.
METHODS


In a phase 2, double-blind study, patients with schizophrenia and AUD experiencing ≥ 10 drinking and ≥ 2 heavy-drinking days in the previous month and recent (≤ 6 mo) disease symptom exacerbation were recruited between June 2014 and March 2017. DSM-IV-TR and DSM-5 criteria were used to assign the diagnoses of schizophrenia and AUD, respectively. After a 6-week lead-in period, 234 eligible patients were randomized (1:1) to olanzapine + 10 mg samidorphan tablets (OLZ/SAM) or olanzapine + placebo tablets (olanzapine) for 36-60 weeks of treatment. The primary outcome of time to the first event of exacerbation of disease symptoms (EEDS) was evaluated using the log rank test for treatment comparison, and the Cox proportional-hazards model was used to estimate hazard ratio. Safety was assessed as adverse events and laboratory measures.
RESULTS


No significant difference was observed between groups in the time to first EEDS (hazard ratio = 0.91; 95% CI, 0.53-1.56; P = .746). Patients treated with OLZ/SAM vs olanzapine had numerically lower rates in 6 of 8 criteria to evaluate EEDS. Change from baseline in percentage of heavy-drinking days during the double-blind treatment period was similar in OLZ/SAM- vs olanzapine-treated patients. OLZ/SAM was generally well tolerated with a safety profile similar to olanzapine.
CONCLUSIONS


OLZ/SAM was not superior to olanzapine in the time to EEDS and was well tolerated in patients with schizophrenia and AUD. Further research is needed to identify effective treatments for this difficult-to-treat population.
TRIAL REGISTRATIONS


ClinicalTrials.gov identifier: NCT02161718; EudraCT number: 2014-001211-39 ​.",2020,Patients treated with OLZ/SAM vs olanzapine had numerically lower rates in 6 of 8 criteria to evaluate EEDS.,"['ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder', 'patients with schizophrenia and AUD experiencing ≥ 10 drinking and ≥ 2 heavy-drinking days in the previous month and recent (≤ 6 mo) disease symptom exacerbation were recruited between June 2014 and March 2017', 'patients with schizophrenia and AUD', '234 eligible patients']","['olanzapine + 10 mg samidorphan tablets (OLZ/SAM) or olanzapine + placebo tablets (olanzapine', 'OLZ/SAM vs olanzapine', 'OLZ/SAM', 'Olanzapine Plus Samidorphan', 'olanzapine']","['adverse events and laboratory measures', 'time to first EEDS', 'time to the first event of exacerbation of disease symptoms (EEDS']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0235874', 'cui_str': 'Disease Exacerbation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",234.0,0.0925487,Patients treated with OLZ/SAM vs olanzapine had numerically lower rates in 6 of 8 criteria to evaluate EEDS.,"[{'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Brunette', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756. Mary.F.Brunette@hitchcock.org.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDonnell', 'Affiliation': 'Alkermes Pharma Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'DiPetrillo', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Bernard L', 'Initials': 'BL', 'LastName': 'Silverman', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Citrome', 'Affiliation': 'New York Medical College, Valhalla, New York, USA.'}, {'ForeName': 'Alan I', 'Initials': 'AI', 'LastName': 'Green', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12786']
657,30117361,Outcomes after Concussion Recovery Education: Effects of Litigation and Disability Status on Maintenance of Symptoms.,"This study examined the hypothesis that people who receive concussion recovery education would have better outcomes than those who received usual discharge paperwork from the emergency department (ED) and tested whether participants who were in litigation or seeking disability compensation had more symptoms than individuals not engaged in these activities. Two hundred and fifty-five persons with a diagnosis of concussion were assigned randomly to a brief education group (one-page double-sided document), a longer education group (10-page document), and usual care (standard ED discharge instructions), and were these documents in the ED. A (non-concussion) trauma comparison group was enrolled to determine the symptom rate unrelated to brain injury. The Concussion Symptom Checklist (CSC) and litigation and disability status questions were completed by telephone at one week, three months, and six months. Neither long nor brief information handouts had a significant impact on symptoms over time; the standard form had an average decrease of 1.20 symptoms compared with the brief instructional intervention group (p = 0.031). Litigation status and disability seeking status were significant predictors of symptoms on CSC over time: disability seeking (p = 0.017) and litigation status (p = 0.05). Persons seeking Social Security disability or legal compensation endorsed more symptoms over time than those who were not. Number of symptoms on the CSC for the trauma control group was the same as those who sustained concussion. Type of recovery material was not as important as noting that concussion symptoms resolve over time, and that remaining symptoms are not specific to brain injury. Litigation and disability seeking behavior accounted for maintained symptoms, rather than the concussion itself.",2019,Neither long nor brief information handouts had a significant impact on symptoms over time; the standard form had an average decrease of 1.20 symptoms compared with the brief instructional intervention group (p = 0.031).,"['people who receive concussion recovery education would have better outcomes than those who received usual discharge paperwork from the emergency department (ED) and tested whether participants who were in litigation or seeking disability compensation had more symptoms than individuals not engaged in these activities', 'Two hundred and fifty-five persons with a diagnosis of concussion']","['Litigation and Disability Status', 'brief education group (one-page double-sided document), a longer education group (10-page document), and usual care (standard ED discharge instructions']","['Maintenance of Symptoms', 'litigation status', 'Litigation and disability seeking behavior', 'Concussion Symptom Checklist (CSC) and litigation and disability status questions', 'Litigation status and disability seeking status']","[{'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220872', 'cui_str': 'litigation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0220872', 'cui_str': 'litigation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220872', 'cui_str': 'litigation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}]",255.0,0.0259797,Neither long nor brief information handouts had a significant impact on symptoms over time; the standard form had an average decrease of 1.20 symptoms compared with the brief instructional intervention group (p = 0.031).,"[{'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Hanks', 'Affiliation': '1 Departments of Physical Medicine and Rehabilitation, Wayne State University School of Medicine , Detroit, Michigan.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Rapport', 'Affiliation': '2 Department of Psychology, Wayne State University College of Liberal Arts and Sciences , Detroit, Michigan.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Seagly', 'Affiliation': '3 Department of Physical Medicine and Rehabilitation, University of Michigan , Ann Arbor, Michigan.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Millis', 'Affiliation': '1 Departments of Physical Medicine and Rehabilitation, Wayne State University School of Medicine , Detroit, Michigan.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': '5 Rainbow Rehabilitation, Livonia, Michigan.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': '4 Department of Emergency Medicine, Wayne State University School of Medicine , Detroit, Michigan.'}]",Journal of neurotrauma,['10.1089/neu.2018.5873']
658,32180239,Better cognitive efficiency is associated with increased experimental anxiety.,"There is increased interest in the development of cognitive training targeting working memory (WM) to alleviate anxiety symptoms, but the effectiveness of such an approach is unclear. Improved understanding of the effect of cognitive training on anxiety may facilitate the development of more effective cognitive training treatment for anxiety disorders. This study uses an experimental approach to examine the interplay of WM and anxiety following WM training. Previous studies show that increased demand on WM reduces concurrent anxiety evoked by threat of shock (induced anxiety). However, improving WM pharmacologically or via exercise prevents this anxiolytic effect. Conceivably, improving WM frees up cognitive resources to process threat information, thereby increasing anxiety. The present study tested the hypothesis that practicing a high load WM (i.e., increased demand) task would improve WM, and thus, free cognitive resources to process threat of shock, resulting in more anxiety (i.e., greater startle) during a subsequent WM task. Participants were randomly assigned to two training groups. The active-training group (N = 20) was trained on a 1- (low load) & 3-back (high load) WM task, whereas the control-training group (N = 20) performed a 0-back WM task. The experimental phase, similar in both groups, consisted of a 1- & 3-back WM task performed during both threat of shock and safety. As predicted, active training improved WM accuracy and increased anxiety during the experimental 3-back WM task. Therefore, improving WM efficiency can increase anxiety, possibly by freeing WM resources to process threat information.",2020,"As predicted, active training improved WM accuracy and increased anxiety during the experimental 3-back WM task.",[],"['active-training group (N\xa0=\xa020) was trained on a 1- (low load) & 3-back (high load) WM task, whereas the control-training group (N\xa0=\xa020) performed a 0-back WM task', 'cognitive training']",['WM accuracy and increased anxiety'],[],"[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",20.0,0.0268519,"As predicted, active training improved WM accuracy and increased anxiety during the experimental 3-back WM task.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Department of Psychiatry, VA Boston Healthcare System, Boston, Massachusetts, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Stahl', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Beale', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Balderston', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}]",Psychophysiology,['10.1111/psyp.13559']
659,32040014,Secondary Analysis of the Efficacy and Safety Trial Data of the Tetravalent Dengue Vaccine in Children and Adolescents in Colombia.,"BACKGROUND


The efficacy of the recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) against virologically-confirmed dengue (VCD) has been documented in a phase 3 trial in Latin America (CYD15, NCT01374516). This is a descriptive secondary analysis of the efficacy and safety of CYD-TDV in participants from Colombia.
METHODS


Data from 9740 Colombian participants 9-16 years of age who were randomized 2:1 to receive CYD-TDV or placebo were assessed to describe the vaccine efficacy of CYD-TDV against VCD and severe VCD. Estimation was made of the relative risk (RR) for hospitalized VCD cases and severe hospitalized VCD cases after the first dose of CYD-TDV, as well as a description of the incidence of hospitalized dengue from the start of the study and per year of the study until study completion.
RESULTS


During the active phase of the trial in Colombia, the efficacy of CYD-TDV was 67.5% [95% confidence interval (CI): 58.3-74.7] against symptomatic VCD due to any serotype from injection 1 (month 0) to 25 months postinjection 1. Over 6 years, the RR across all 4 serotypes was 0.166 (95% CI: 0.09-0.29) in hospitalized VCD patients and 0.154 (95% CI: 0.04-0.50) in patients with severe hospitalized VCD.
CONCLUSIONS


Analysis of the data from Colombia mimics the efficacy observed in CYD15 during the active surveillance follow-up (25 months), but with a sustained beneficial RR for dengue hospitalizations on the subsequent years of follow-up. In Colombia, where seroprevalence has been demonstrated to be high in several regions of the country, CYD-TDV is a useful tool to consider as part of an integrated control strategy against endemic dengue, a disease with a high economic impact on the health system.",2020,"Over 6 years, the RR across all 4 serotypes was 0.166","['participants from Colombia', 'Data from 9740 Colombian participants 9-16 years of age who', 'Children and Adolescents in Colombia']","['CYD-TDV', 'Tetravalent Dengue Vaccine', 'CYD-TDV or placebo']","['symptomatic VCD', 'vaccine efficacy of CYD-TDV against VCD and severe VCD']","[{'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",9740.0,0.2911,"Over 6 years, the RR across all 4 serotypes was 0.166","[{'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Reynales', 'Affiliation': 'From the Centro de Atención e Investigación Médica - CAIMED, Bogotá, Colombia.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Carrasquilla', 'Affiliation': 'Fundación Santa Fe de Bogotá, Bogotá, Colombia.'}, {'ForeName': 'Betzana', 'Initials': 'B', 'LastName': 'Zambrano', 'Affiliation': 'Sanofi Pasteur Global Clinical Sciences, Montevideo, Uruguay.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Cortés S', 'Affiliation': 'Sanofi Global Head Medical, Bogotá, Colombia.'}, {'ForeName': 'Tifany', 'Initials': 'T', 'LastName': 'Machabert', 'Affiliation': ""Sanofi Pasteur Global Clinical Programs, Marcy L'Étoile, France.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Biostatistics and Programming, Clinical Scientific Operations, Sanofi, Beijing, China.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pallardy', 'Affiliation': ""Sanofi Pasteur Global Clinical Programs, Marcy L'Étoile, France.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Haney', 'Affiliation': 'Sanofi Pasteur Global Pharmacovigilance, Swiftwater, PA, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Faccini', 'Affiliation': 'From the Centro de Atención e Investigación Médica - CAIMED, Bogotá, Colombia.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Quintero', 'Affiliation': 'Fundación Santa Fe de Bogotá, Bogotá, Colombia.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Noriega', 'Affiliation': 'Sanofi Pasteur Global Clinical Sciences, Swiftwater, PA, USA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002580']
660,32167957,Adding Contralaterally Controlled Electrical Stimulation of the Triceps to Contralaterally Controlled Functional Electrical Stimulation of the Finger Extensors Reduces Upper Limb Impairment and Improves Reachable Workspace but not Dexterity: A Randomized Controlled Trial.,"OBJECTIVE


Different methods of neuromuscular electrical stimulation may be used for poststroke upper limb rehabilitation. This study evaluated the effects of contralaterally controlled functional electrical stimulation of the triceps and finger extensors.
DESIGN


This is a randomized controlled trial of 67 participants who were less than 2 yrs poststroke and assigned to the following: (a) arm + hand contralaterally controlled functional electrical stimulation, (b) hand contralaterally controlled functional electrical stimulation, or (c) arm + hand cyclic neuromuscular electrical stimulation. Participants were prescribed 10 sessions/week of assigned electrical stimulation at home plus 24 sessions of functional task practice in the laboratory for 12 wks. The primary outcome measure was the Box and Blocks Test. Secondary measures included reachable workspace, Upper Extremity Fugl-Meyer, Stroke Upper Limb Capacity Scale, Arm Motor Abilities Test, and Motor Activity Log.
RESULTS


There were no significant between-group differences on the Box and Blocks Test. At 6 mos after treatment, arm + hand contralaterally controlled functional electrical stimulation improved reachable workspace more than hand contralaterally controlled functional electrical stimulation, between-group difference of 264 (95% confidence interval = 28-500) cm and more than arm + hand cyclic neuromuscular electrical stimulation, between-group difference of 281 (95% confidence interval = 22-540) cm. Arm + hand contralaterally controlled functional electrical stimulation improved Upper Extremity Fugl-Meyer score more than hand contralaterally controlled functional electrical stimulation, between-group difference of 6.7 (95% confidence interval = 0.6-12.7). The between-group differences on the Stroke Upper Limb Capacity Scale and Arm Motor Abilities Test were not significant.
CONCLUSIONS


Adding contralaterally controlled elbow extension to hand contralaterally controlled functional electrical stimulation does not improve on gains in hand dexterity, but it further reduces upper limb impairment and improves reachable workspace measured in the laboratory. However, these additional benefits may not be large enough to be perceived by stroke survivors when they are performing activities of daily living at home.",2020,"CCFES improved UEFM score more than Hand CCFES, between-group difference of 6.7 (95% CI, 0.6-12.7).",['67 participants <2 years post-stroke assigned to'],"['neuromuscular electrical stimulation (NMES', 'contralaterally controlled functional electrical stimulation (CCFES']","['theSULCS and AMAT', 'Box and Blocks Test (BBT', 'reachable workspace', 'UEFM score', 'Reachable Workspace (RW), Upper Extremity Fugl-Meyer (UEFM), Stroke Upper Limb Capacity Scale (SULCS), and Arm Motor Abilities Test (AMAT), and Motor Activity Log (MAL', 'BBT']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]",67.0,0.175681,"CCFES improved UEFM score more than Hand CCFES, between-group difference of 6.7 (95% CI, 0.6-12.7).","[{'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, MetroHealth Rehabilitation Institute (JSK, NSM, MYH, TZH, RDW, JC), and the Center for Healthcare Research and Policy (DDG), The MetroHealth System, Cleveland, Ohio; Cleveland Functional Electrical Stimulation Center, Cleveland, Ohio (JSK, NSM, MYH, TZH, RDW, JC); and Departments of Physical Medicine and Rehabilitation (JSK, NSM, RDW, JC), Medicine (DDG), and Biomedical Engineering (JC), Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Makowski', 'Affiliation': ''}, {'ForeName': 'Mary Y', 'Initials': 'MY', 'LastName': 'Harley', 'Affiliation': ''}, {'ForeName': 'Terri Z', 'Initials': 'TZ', 'LastName': 'Hisel', 'Affiliation': ''}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Gunzler', 'Affiliation': ''}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001363']
661,32171815,Efficacy of targeted education in reducing topical steroid phobia: A randomized clinical trial.,"BACKGROUND


Fear of adverse effects of corticosteroids is common in dermatology and results in medication nonadherence.
OBJECTIVE


To study the efficacy of targeted education in reducing topical steroid phobia.
METHODS


In this double-blinded, randomized controlled trial, participants in the intervention arm were presented with an educational video and patient information leaflet targeting common misconceptions of topical corticosteroids. Steroid phobia was assessed with the topical corticosteroid phobia (TOPICOP) scale, medication adherence with the Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux (ECOB) score, and quality of life with the Dermatology Life Quality Index (DLQI).
RESULTS


The study randomized 275 patients. The mean TOPICOP score in the intervention arm decreased (improved) from 41.9 (SD, 17.4) to 37.1 (SD, 20.0) and to 33.8 (SD, 19.0) at 1 month and 3 months, respectively, with the reduction arising from the knowledge domain but not the fears and behaviors domain. This remained statistically significant after adjusting for demographic confounding with an expected reduction of 4.22 points (P = .031). After accounting for demographic factors, there was no statistical difference in medication adherence and quality of life. Limitations include the exclusion of non-English-speaking patients.
CONCLUSION


Targeted education at a single time point improved the TOPICOP score primarily in the knowledge domain but not in the fear domain.",2020,"© score in the intervention arm decreased (improved) from 41.9 (SD,17.4) to 37.1 (SD,20.0) and 33.8 (SD,19.0) at 1 month and 3 months, respectively with the reduction arising from the knowledge domain but not the fears and behaviours domain.",['275 patients were randomised'],"['TOPICOP', 'educational video and patient information leaflet targeting common misconceptions of topical corticosteroids', 'corticosteroids', 'Targeted Education']","['Mean (SD) TOPICOP', 'medication adherence and quality of life', '© scale, medication adherence with the ECOB score, and quality of life with the DLQI', 'Steroid phobia']","[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0034380'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]",275.0,0.151103,"© score in the intervention arm decreased (improved) from 41.9 (SD,17.4) to 37.1 (SD,20.0) and 33.8 (SD,19.0) at 1 month and 3 months, respectively with the reduction arising from the knowledge domain but not the fears and behaviours domain.","[{'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore. Electronic address: ellie_choi@nuhs.edu.sg.'}, {'ForeName': 'Ken Wei', 'Initials': 'KW', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Fengjie', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Nisha Suyien', 'Initials': 'NS', 'LastName': 'Chandran', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.079']
662,32164428,Headache and non-headache symptoms provoked by nitroglycerin in migraineurs: A human pharmacological triggering study.,"BACKGROUND


Studying a spontaneous migraine attack is challenging, particularly the earliest components. Nitroglycerin is a potent, reliable and reproducible migraine trigger of the entirety of the migraine attack, making its use experimentally attractive.
METHODS


Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms were exposed to a 0.5 mcg/kg/min nitroglycerin infusion. Eighty-three percent (n = 44) developed typical premonitory and headache symptomatology. Fifty-seven percent (n = 25) were invited back to further study visits, during which they were re-exposed to nitroglycerin or placebo infusion in a double-blind randomised design. The phenotype of premonitory symptoms and headache was captured and compared to spontaneous attacks and between triggered attacks using agreement analysis.
RESULTS


More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001). The agreement in triggering for the most commonly reported premonitory symptoms (concentration difficulty and tiredness) was >66%. The retriggering agreement for all but one premonitory symptom was >60%. The agreement in timing to onset of premonitory symptoms was reliable across two triggered attacks. The agreement with spontaneous attacks and between attacks for headache and its associated symptoms, including laterality, was less reliable.
CONCLUSIONS


Nitroglycerin can reliably and reproducibly provoke premonitory symptomatology associated with migraine. This forms an ideal model to study the earliest manifestations of migraine attacks.",2020,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001).","['Eighty-three percent (n\u2009', 'migraineurs', 'Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms', 'Fifty-seven percent (n\u2009']","['nitroglycerin or placebo infusion', 'nitroglycerin infusion', 'placebo', 'Nitroglycerin', 'nitroglycerin']","['Headache', 'typical premonitory and headache symptomatology']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0240805', 'cui_str': 'Prodrome'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",53.0,0.162561,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001).","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jayde', 'Initials': 'J', 'LastName': 'Newman', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102420910114']
663,31740426,The N-AcetylCysteine and RAMipril in Takotsubo Syndrome Trial (NACRAM): Rationale and design of a randomised controlled trial of sequential N-Acetylcysteine and ramipril for the management of Takotsubo Syndrome.,"BACKGROUND


Takotsubo Syndrome(TTS), contrary to historical reports, is now increasingly recognised to be associated with substantial mortality and morbidity, both in the short- and long-term. Although TTS is often precipitated by a catecholamine ""pulse"", in-hospital hypotension is a common occurrence, increasing the risk of mortality. Furthermore, despite the transient catecholamine stimulus, there is increasing evidence that there are significant long term sequelae, including persistently impaired left ventricular(LV) systolic dysfunction, myocardial oedema with fibrosis, as well as persistent impairment of quality of life. A definitive therapeutic option to limit the extent of initial myocardial injury, and to accelerate recovery in TTS is therefore justified. However to date, there has been a lack of prospective studies in this area.
DESIGN AND RATIONALE


NACRAM is a multi-centre, randomised, placebo-controlled trial, sequentially testing early use of intravenous N-acetylcysteine(NAC), followed by/or oral ramipril for 12 weeks. The rationale for utilising these agents is related to their effects on limiting nitrosative stress and expression of the inflammasome activator thioredoxin interacting protein(TXNIP); both processes fundamental to the pathogenesis of TTS.
END POINTS


NACRAM is assessing resolution of myocardial oedema on cardiac magnetic resonance imaging(CMR), improvements in LV systolic function as measured by global longitudinal strain(GLS) on echocardiography, quality of life, and inflammatory markers.
DISCUSSION


To the best of our knowledge, NACRAM will be the first prospective study to help definitively evaluate a therapeutic option in acute attacks of TTS.",2020,"NACRAM is assessing resolution of myocardial oedema on cardiac magnetic resonance imaging(CMR), improvements in LV systolic function as measured by global longitudinal strain(GLS) on echocardiography, quality of life, and inflammatory markers.
",['Takotsubo Syndrome'],"['TTS', 'AcetylCysteine and RAMipril', 'placebo', 'intravenous N-acetylcysteine(NAC', 'sequential N-Acetylcysteine and ramipril', 'NACRAM', 'oral ramipril']","['echocardiography, quality of life, and inflammatory markers', 'LV systolic function']","[{'cui': 'C1739395', 'cui_str': 'Tako-tsubo Cardiomyopathy'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0034380'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0619176,"NACRAM is assessing resolution of myocardial oedema on cardiac magnetic resonance imaging(CMR), improvements in LV systolic function as measured by global longitudinal strain(GLS) on echocardiography, quality of life, and inflammatory markers.
","[{'ForeName': 'Gao Jing', 'Initials': 'GJ', 'LastName': 'Ong', 'Affiliation': 'Cardiology Unit, Queen Elizabeth Hospital, Woodville, SA, Australia; University of Adelaide, Basil Hetzel Institute, Woodville, SA, Australia; Cardiology Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Thanh Ha', 'Initials': 'TH', 'LastName': 'Nguyen', 'Affiliation': 'Cardiology Unit, Queen Elizabeth Hospital, Woodville, SA, Australia; University of Adelaide, Basil Hetzel Institute, Woodville, SA, Australia.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Stansborough', 'Affiliation': 'Cardiology Unit, Queen Elizabeth Hospital, Woodville, SA, Australia.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Surikow', 'Affiliation': 'Cardiology Unit, Queen Elizabeth Hospital, Woodville, SA, Australia; University of Adelaide, Basil Hetzel Institute, Woodville, SA, Australia.'}, {'ForeName': 'Gnanadevan', 'Initials': 'G', 'LastName': 'Mahadavan', 'Affiliation': 'Cardiology Unit, Queen Elizabeth Hospital, Woodville, SA, Australia; University of Adelaide, Basil Hetzel Institute, Woodville, SA, Australia; Cardiology Unit, Royal Adelaide Hospital, Adelaide, SA, Australia; Cardiology Unit, Lyell McEwin Hospital, Elizabeth Vale, SA, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Worthley', 'Affiliation': 'Cardiology Unit, Queen Elizabeth Hospital, Woodville, SA, Australia; University of Adelaide, Basil Hetzel Institute, Woodville, SA, Australia; Cardiology Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Horowitz', 'Affiliation': 'Cardiology Unit, Queen Elizabeth Hospital, Woodville, SA, Australia; University of Adelaide, Basil Hetzel Institute, Woodville, SA, Australia. Electronic address: john.horowitz@adelaide.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105894']
664,31740428,"A physician-initiated double-blind, randomised, placebo-controlled, phase 2 study evaluating the efficacy and safety of inhibition of NADPH oxidase with the first-in-class Nox-1/4 inhibitor, GKT137831, in adults with type 1 diabetes and persistently elevated urinary albumin excretion: Protocol and statistical considerations.","PURPOSE


Kidney disease caused by type 1 diabetes can progress to end stage renal disease and can increase mortality risk. Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (Nox) plays a major role in producing oxidative stress in the kidney in diabetes, and its activity is attenuated by GKT137831, an oral Nox inhibitor with predominant inhibitory action on Nox-1 and Nox - 4. Previous studies have demonstrated renoprotective effects with GKT137831 in various experimental models of type 1 diabetes-related kidney disease. This study will evaluate the effect of GKT137831 in treating clinical diabetic kidney disease.
DESIGN


This is a multi-center, randomized, placebo-controlled trial, parallel arm study evaluating the effect on albuminuria of treatment with GKT137831 400 mg BID for 48 weeks. The study will randomize 142 participants who have persistent albuminuria and estimated glomerular filtration rate (eGFR) at baseline of at least 40 ml/min/1.73m 2 .
PRIMARY OUTCOME MEASURES


Difference between arms in urine albumin to creatinine ratio. Secondary outcome measures include eGFR.
CONCLUSION


This study is important because it may identify a new way of slowing renal disease progression in people with type 1 diabetes and albuminuria already receiving standard of care treatment.",2020,"This is a multi-center, randomised, placebo-controlled trial, parallel arm study evaluating the effect on albuminuria of treatment with GKT137831 200 mg BID for 48 weeks.","['142 participants who have persistent albuminuria and estimated glomerular filtration rate (eGFR) at baseline of at least 40\u202fml/min/1.73m 2 ', 'people with type 1 diabetes and albuminuria already receiving standard of care treatment', 'adults with type 1 diabetes and persistently elevated urinary albumin excretion']","['placebo', 'GKT137831', 'Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (Nox', 'NADPH oxidase']","['urine albumin to creatinine ratio', 'eGFR']","[{'cui': 'C4546070', 'cui_str': 'Persistent albuminuria'}, {'cui': 'C3811844'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3529183', 'cui_str': 'GKT137831'}, {'cui': 'C0027303', 'cui_str': 'NADPH'}, {'cui': 'C0242417', 'cui_str': 'Oxidases'}, {'cui': 'C0068355', 'cui_str': 'NADPH Oxidase'}]","[{'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",142.0,0.28594,"This is a multi-center, randomised, placebo-controlled trial, parallel arm study evaluating the effect on albuminuria of treatment with GKT137831 200 mg BID for 48 weeks.","[{'ForeName': 'Anne T', 'Initials': 'AT', 'LastName': 'Reutens', 'Affiliation': 'Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: anne.reutens@baker.edu.au.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Jandeleit-Dahm', 'Affiliation': 'Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: karin.jandeleit-dahm@monash.edu.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: merlin.thomas@monash.edu.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Salim', 'Affiliation': 'Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: Agus.Salim@baker.edu.au.'}, {'ForeName': 'Alysha M', 'Initials': 'AM', 'LastName': 'De Livera', 'Affiliation': 'Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: Alysha.deLivera@baker.edu.au.'}, {'ForeName': 'Leon A', 'Initials': 'LA', 'LastName': 'Bach', 'Affiliation': 'Department of Endocrinology and Diabetes, Level 5 Centre Block, The Alfred, PO Box 315, Prahran, VIC 3181, Australia; Monash University, Department of Medicine, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: l.bach@alfred.org.au.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Colman', 'Affiliation': 'Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, RMH VIC 3050, Australia. Electronic address: peter.colman@mh.org.au.'}, {'ForeName': 'Timothy M E', 'Initials': 'TME', 'LastName': 'Davis', 'Affiliation': 'University of Western Australia, Medical School, Fremantle Hospital, PO Box 480, Fremantle, WA 6959, Australia. Electronic address: tim.davis@uwa.edu.au.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Medicine, The University of Melbourne and Department of Endocrinology, Austin Health, Heidelberg Repatriation Hospital, Department of Medicine, Boronia Building, Level 1, 300 Waterdale Rd, Heidelberg, VIC 3081, Australia. Electronic address: elif.ekinci@unimelb.edu.au.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Department of Endocrinology, Level 3, Acute Services Building, Royal North Shore Hospital, St Leonards, NSW 2065, Australia; The University of Sydney NSW 2006, Australia. Electronic address: greg.fulcher@sydney.edu.au.'}, {'ForeName': 'Peter Shane', 'Initials': 'PS', 'LastName': 'Hamblin', 'Affiliation': 'Diabetes & Endocrinology Centre, Sunshine Hospital, 176 Furlong Road, St Albans, VIC 3021, Australia; Department of Medicine-Western Precinct, University of Melbourne, St Albans, VIC 3021, Australia. Electronic address: Peter.Hamblin@wh.org.au.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Kotowicz', 'Affiliation': 'Deakin University, Geelong, VIC, Australia. Electronic address: markk@barwonhealth.org.au.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': ""Department of Endocrinology & Diabetes, Level 4 Daly Wing, St Vincent's Hospital, University of Melbourne, PO Box 2900, Fitzroy, VIC 3065, Australia. Electronic address: richard.macisaac@svha.org.au.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Morbey', 'Affiliation': 'Hunter Diabetes Centre, Level 1, 41 Llewellyn Street, Merewether, NSW 2291, Australia. Electronic address: drmorbey@hunterdiabetes.com.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown Hospital, Therry Rd, Campbelltown, NSW 2560, Australia. Electronic address: da.simmons@westernsydney.edu.au.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Soldatos', 'Affiliation': 'Diabetes and Vascular Medicine Unit, Monash Health, 246 Clayton Road, Clayton, VIC 3168, Australia. Electronic address: Georgia.Soldatos@monashhealth.org.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building, Corner of North Terrace and George Street, Adelaide, SA 5005, Australia. Electronic address: gary.wittert@adelaide.edu.au.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Diabetes Centre, Level 6, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050, Australia; The University of Sydney NSW 2006, Australia. Electronic address: Ted.Wu@health.nsw.gov.au.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: mark.cooper@monash.edu.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: jonathan.shaw@baker.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105892']
665,32165027,Burn scar outcome at six and 12 months after injury in children with partial thickness scalds: Effects of dressing treatment.,"INTRODUCTION


In line with other researchers in the field of burns' care, we think that research investigating the long-term outcome of scars is largely lacking. As scarring is of the utmost importance to the patient, clinicians who treat burns must aim to find treatments that lead to a good end result. The aim of this study was to study scar outcomes at six and 12 months after injury. It is an extension of a previous randomised controlled trial (RCT) in which two dressings (porcine xenograft and silver foam dressing) were examined with respect to their ability to help heal partial thickness scalds.
METHOD


Children aged six months - six years with acute partial thickness scalds, on the trunk, or extremities, or both, were included. In the previous study, the silver foam was found to have significantly shorter healing times than the xenograft. Children were assessed at six and 12 months after injury for this study, and photographs were taken of the burn site, and both the patient and observer scar assessment scale (POSAS) and the Vancouver scar scale (VSS) were completed and evaluated by blinded observers.
RESULTS


Of the 58 children from the original RCT, 39 returned to the clinic for evaluation of their scars at six months, and 34 at 12 months after injury. There were no differences in POSAS, VSS total scores, or incidence of hypertrophic scarring between the different dressings. Fifteen children were assessed as having hypertrophic scarring, all of whom had healing times that had extended beyond 14 days.
CONCLUSIONS


This study compared burn scarring after two different treatments for burns in children with partial-thickness scalds and the data suggested that neither dressing had a more favourable impact on scar outcome. The conclusion is, however, tempered by the non-return of all the patients to the follow up. However, as anticipated, regardless of the dressing used, longer healing times were associated with higher scar scores (more scarring) and hypertrophic scarring.",2020,"There were no differences in POSAS, VSS total scores, or incidence of hypertrophic scarring between the different dressings.","['Children aged six months - six years with acute partial thickness scalds, on the trunk, or extremities, or both, were included', '58 children from the original RCT', 'burns in children with partial-thickness scalds', 'children with partial thickness scalds']",[],"['observer scar assessment scale (POSAS) and the Vancouver scar scale (VSS', 'having hypertrophic scarring', 'POSAS, VSS total scores, or incidence of hypertrophic scarring', 'longer healing times', 'scar scores (more scarring) and hypertrophic scarring', 'healing times', 'scar outcome']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0332691', 'cui_str': 'Scalding injury (morphologic abnormality)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}]",[],"[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",15.0,0.0225455,"There were no differences in POSAS, VSS total scores, or incidence of hypertrophic scarring between the different dressings.","[{'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Karlsson', 'Affiliation': 'Department of Hand Surgery, Plastic Surgery and Burns, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden. Electronic address: Matilda.Karlsson@regionostergotland.se.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Steinvall', 'Affiliation': 'Department of Hand Surgery, Plastic Surgery and Burns, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Sjöberg', 'Affiliation': 'Department of Hand Surgery, Plastic Surgery and Burns, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden; Department of Anesthesiology and Intensive Care, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Olofsson', 'Affiliation': 'Department of Hand Surgery, Plastic Surgery and Burns, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Elmasry', 'Affiliation': 'Department of Hand Surgery, Plastic Surgery and Burns, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.02.007']
666,32102812,"How, in what contexts, and why do quality dashboards lead to improvements in care quality in acute hospitals? Protocol for a realist feasibility evaluation.","INTRODUCTION


National audits are used to monitor care quality and safety and are anticipated to reduce unexplained variations in quality by stimulating quality improvement (QI). However, variation within and between providers in the extent of engagement with national audits means that the potential for national audit data to inform QI is not being realised. This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet).
METHODS AND ANALYSIS


Realist evaluation, which involves building, testing and refining theories of how an intervention works, provides an overall framework for this feasibility study. Realist hypotheses that describe how, in what contexts, and why QualDash is expected to provide benefit will be tested across five hospitals. A controlled interrupted time series analysis, using key MINAP and PICANet measures, will provide preliminary evidence of the impact of QualDash, while ethnographic observations and interviews over 12 months will provide initial insight into contexts and mechanisms that lead to those impacts. Feasibility outcomes include the extent to which MINAP and PICANet data are used, data completeness in the audits, and the extent to which participants perceive QualDash to be useful and express the intention to continue using it after the study period.
ETHICS AND DISSEMINATION


The study has been approved by the University of Leeds School of Healthcare Research Ethics Committee. Study results will provide an initial understanding of how, in what contexts, and why quality dashboards lead to improvements in care quality. These will be disseminated to academic audiences, study participants, hospital IT departments and national audits. If the results show a trial is feasible, we will disseminate the QualDash software through a stepped wedge cluster randomised trial.",2020,"This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet).
",[],['QualDash'],[],[],[],[],,0.129498,"This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet).
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randell', 'Affiliation': 'Faculty of Health Studies, University of Bradford, Bradford, West Yorkshire, UK r.randell@bradford.ac.uk.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Alvarado', 'Affiliation': 'Wolfson Centre for Applied Health Research, Bradford, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'McVey', 'Affiliation': 'Wolfson Centre for Applied Health Research, Bradford, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Greenhalgh', 'Affiliation': 'Sociology and Social Policy, University of Leeds, Leeds, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'West', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Parslow', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Keen', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Elshehaly', 'Affiliation': 'Faculty of Engineering & Informatics, University of Bradford, Bradford, UK.'}, {'ForeName': 'Roy A', 'Initials': 'RA', 'LastName': 'Ruddle', 'Affiliation': 'School of Computing, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lake', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Mamas', 'Initials': 'M', 'LastName': 'Mamas', 'Affiliation': 'Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feltbower', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Dowding', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, Greater Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033208']
667,31618208,Kaposi's sarcoma-associated herpesvirus seropositivity is associated with parasite infections in Ugandan fishing communities on Lake Victoria islands.,"We investigated the impact of helminths and malaria infection on Kaposi's sarcoma associated herpesvirus (KSHV) seropositivity, using samples and data collected from a cluster-randomised trial of intensive versus standard anthelminthic treatment. The trial was carried out in 2012 to 2016 among fishing communities on Lake Victoria islands in Uganda. Plasma samples from 2881 participants from two household surveys, the baseline (1310 participants) and the final (1571 participants) surveys were tested for KSHV IgG antibody responses to K8.1 and ORF73 recombinant proteins using ELISA. The baseline survey was carried out before the trial intervention while the final survey was carried out after three years of the trial intervention. Additionally, a subset sample of 372 participants from the final survey was tested for IgE, IgG and IgG4 antibody concentrations to S. mansoni adults worm antigen (SWA) and S. mansoni egg antigen (SEA) using ELISA. Infection by helminths (S. mansoni, N. americanus, T. trichiura and S. stercoralis) was diagnosed using real-time PCR, urine circulating cathodic antigen (CCA) and stool microscopy (Kato-Katz method) while malaria infection was diagnosed using microscopy. We analysed the relationship between helminth and malaria infections and KSHV seropositivity using regression modelling, allowing for survey design. At baseline, 56% of the participants were male while 48% of the participants were male in the final survey. The most prevalent helminth infection was S. mansoni (at baseline 52% and 34% in the final survey by microscopy, 86% by CCA and 50% by PCR in the final survey). KSHV seropositivity was 66% (baseline) and 56% (final survey) among those 1-12 years and >80% in those 13+ years in both surveys; malaria parasitaemia prevalence was 7% (baseline) and 4% (final survey). At baseline, individuals infected with S. mansoni (detected by microscopy) were more likely to be KSHV seropositive (aOR = 1.86 (1.16, 2.99) p = 0.012) and had higher anti-K8.1 antibody levels (acoefficient = 0.03 (0.01, 0.06) p = 0.02). In the final survey, S. mansoni (by microscopy, adjusted Odds Ratio (aOR = 1.43 (1.04-1.95), p = 0.028) and malaria parasitaemia (aOR = 3.49 (1.08-11.28), p = 0.038) were positively associated with KSHV seropositivity. Additionally, KSHV seropositive participants had higher S. mansoni-specific IgE and IgG antibody concentrations in plasma. Furthermore, HIV infected individuals on cART were less likely to be KSHV seropositive compared to HIV negative individuals (aOR = 0.46 (0.30, 0.71) p = 0.002). Schistosoma species skew the immune response towards Th2 and regulatory responses, which could impact on KSHV reactivation if co-infected with both organisms.",2019,"In the final survey, S. mansoni (by microscopy, adjusted Odds Ratio (aOR = 1.43 (1.04-1.95), p = 0.028) and malaria parasitaemia (aOR = 3.49 (1.08-11.28), p = 0.038) were positively associated with KSHV seropositivity.","['2881 participants from two household surveys, the baseline (1310 participants) and the final (1571 participants) surveys were tested for KSHV IgG antibody responses to K8.1 and ORF73 recombinant proteins using ELISA', '2012 to 2016 among fishing communities on Lake Victoria islands in Uganda', 'Ugandan fishing communities on Lake Victoria islands', '372 participants from the final survey']",[],"['malaria parasitaemia prevalence', 'higher anti-K8.1 antibody levels', 'KSHV seropositivity', 'KSHV seropositive', 'higher S. mansoni-specific IgE and IgG antibody concentrations in plasma', 'IgE, IgG and IgG4 antibody concentrations to S. mansoni adults worm antigen (SWA) and S. mansoni egg antigen (SEA', 'malaria parasitaemia']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376526', 'cui_str': 'Kaposi Sarcoma-Associated Herpesvirus'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0034861', 'cui_str': 'Biosynthetic Proteins'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}]",[],"[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376526', 'cui_str': 'Kaposi Sarcoma-Associated Herpesvirus'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020860', 'cui_str': 'IgG4'}, {'cui': 'C0018889', 'cui_str': 'Helminthiasis'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}]",1310.0,0.0578699,"In the final survey, S. mansoni (by microscopy, adjusted Odds Ratio (aOR = 1.43 (1.04-1.95), p = 0.028) and malaria parasitaemia (aOR = 3.49 (1.08-11.28), p = 0.038) were positively associated with KSHV seropositivity.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Nalwoga', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Chihota', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Wendell', 'Initials': 'W', 'LastName': 'Miley', 'Affiliation': 'Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, Maryland, United States of America.'}, {'ForeName': 'Bridgious', 'Initials': 'B', 'LastName': 'Walusimbi', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Jacent', 'Initials': 'J', 'LastName': 'Nassuuna', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Sanya', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Gyaviira', 'Initials': 'G', 'LastName': 'Nkurunungi', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Nazzarena', 'Initials': 'N', 'LastName': 'Labo', 'Affiliation': 'Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, Maryland, United States of America.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cose', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Whitby', 'Affiliation': 'Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, Maryland, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Newton', 'Affiliation': 'MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0007776']
668,31367877,Fecal Microbiota Transplant via Endoscopic Delivering Through Small Intestine and Colon: No Difference for Crohn's Disease.,"BACKGROUND AND AIMS


Crohn's disease (CD) is a chronic inflammatory bowel disorder associated with intestinal dysbiosis. This study aimed to determine the efficacy and safety of different methods of fecal microbiota transplantation (FMT), a potential therapy for CD.
METHODS


Patients with CD were randomized to receive FMT by gastroscopy or colonoscopy; a second transplantation was performed 1 week later. Patients were assessed by clinical evaluation and serum testing (at weeks 1, 2, 4, 6, and 8) and endoscopy (8 weeks after transplantation). Fecal DNA was extracted and analyzed using the Illuminal sequencing platform.
RESULTS


Of the 27 patients included in the study, clinical remission was achieved in 18 (66.7%); no significant difference was seen between the two methods. 76.9% of gastroscopy group patients and 64.3% of colonoscopy group patients experienced mild adverse events during or shortly after treatment. Microbiota diversity analyses showed that, in comparison with the donors, patients had lower operational taxonomic units (OTU; 117 vs. 258, p < 0.05) and Shannon diversity index (2.05 vs. 3.46, p < 0.05). The CD patients showed a significant increase in OTU and Shannon diversity index 2 weeks after FMT. In comparison with the donors, CD patients had lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus.
CONCLUSIONS


FMT was seen to be safe and effective in this cohort of patients with CD. No significant differences in clinical remission rate and adverse events were seen between the gastroscopy and colonoscopy groups. FMT was seen to increase the species richness in CD patients.",2020,"In comparison with the donors, CD patients had lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus.
","['Patients with CD', 'Fecal Microbiota Transplant via Endoscopic Delivering Through Small Intestine and Colon', '27 patients included in the study']","['FMT by gastroscopy or colonoscopy', 'FMT', 'fecal microbiota transplantation (FMT']","['clinical remission', 'species richness', 'mild adverse events', 'Fecal DNA', 'efficacy and safety', 'Shannon diversity index', 'OTU and Shannon diversity index', 'safe and effective', 'lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus', 'clinical remission rate and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004661', 'cui_str': 'Bacteroides'}, {'cui': 'C0015146', 'cui_str': 'Eubacterium'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C1894384', 'cui_str': 'Cronobacter'}, {'cui': 'C0016878', 'cui_str': 'Sphaerophorus'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}]",,0.0487709,"In comparison with the donors, CD patients had lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus.
","[{'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chibin', 'Initials': 'C', 'LastName': 'Bu', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Quan', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Changxin', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China. wxy20011@163.com.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05751-y']
669,31367878,Chyme Reinfusion Is Associated with Lower Rate of Postoperative Ileus in Crohn's Disease Patients After Stoma Closure.,"BACKGROUND


The rate of postoperative ileus following stoma closure is high in patients with Crohn's disease and temporary enterostomy.
AIMS


To evaluate the effect of chyme reinfusion on postoperative outcomes including ileus in these patients.
METHODS


Patients were screened from January 2012 to December 2017 and divided into chyme reinfusion group (n = 33) and non-chyme reinfusion group (n = 84). The following 30-day postoperative outcomes were evaluated. Univariate and multivariate analyses and propensity score matching were performed to identify risk factors for these postoperative outcomes.
RESULTS


The incidence of postoperative ileus was significantly lower in the chyme reinfusion than in non-chyme reinfusion group, which had been confirmed by the results after matching (3/26 vs 11/26, p = 0.012). The rate of postoperative diarrhea was significantly lower in the chyme reinfusion group compared with non-chyme reinfusion group, whereas the difference was not significant after matching (2/26 vs 6/26, p = 0.191). Additionally, the postoperative length of stay was significantly shorter in the chyme reinfusion than in non-chyme reinfusion group before and after propensity score matching. In the multivariate analysis, chyme reinfusion was an independent protective factor for postoperative ileus (odds ratio 0.218; 95% confidence interval 0.05-0.95; p = 0.042) and for postoperative length of stay (coefficient - 0.191; 95% confidence interval - 0.350 to - 0.032, p = 0.019).
CONCLUSIONS


Chyme reinfusion was associated with lower rate of postoperative ileus and shorter length of stay following stoma closure in Crohn's patients with temporary ileostomy. Further randomized clinical trial between patients with or without chyme reinfusion was needed to confirm these conclusions.",2020,"The incidence of postoperative ileus was significantly lower in the chyme reinfusion than in non-chyme reinfusion group, which had been confirmed by the results after matching (3/26 vs 11/26, p = 0.012).","[""Crohn's Disease Patients After Stoma Closure"", ""Crohn's patients with temporary ileostomy"", ""patients with Crohn's disease and temporary enterostomy"", 'ileus in these patients', 'patients with or without chyme reinfusion', 'Patients were screened from January 2012 to December 2017 and divided into chyme reinfusion group (n\u2009=\u200933) and non-chyme reinfusion group (n\u2009=\u200984']","['Chyme Reinfusion', 'chyme reinfusion']","['incidence of postoperative ileus', 'postoperative length of stay', 'protective factor for postoperative ileus', 'rate of postoperative diarrhea']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3665863', 'cui_str': 'Stoma closure'}, {'cui': 'C0010346', 'cui_str': 'Regional Enteritis'}, {'cui': 'C2937270', 'cui_str': 'Creation of temporary ileostomy (procedure)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1442523', 'cui_str': 'Enterostomy (morphologic abnormality)'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0227258', 'cui_str': 'Small intestine contents (substance)'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0227258', 'cui_str': 'Small intestine contents (substance)'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.072543,"The incidence of postoperative ileus was significantly lower in the chyme reinfusion than in non-chyme reinfusion group, which had been confirmed by the results after matching (3/26 vs 11/26, p = 0.012).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China. liyi.jlh@hotmail.com.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China. juwiming@nju.edu.cn.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05753-w']
670,31422134,Ticagrelor to Reduce Myocardial Injury in Patients With High-Risk Coronary Artery Plaque.,"OBJECTIVES


The goal of this study was to determine whether ticagrelor reduces high-sensitivity troponin I concentrations in patients with established coronary artery disease and high-risk coronary plaque.
BACKGROUND


High-risk coronary atherosclerotic plaque is associated with higher plasma troponin concentrations suggesting ongoing myocardial injury that may be a target for dual antiplatelet therapy.
METHODS


In a randomized, double-blind, placebo-controlled trial, patients with multivessel coronary artery disease underwent coronary  18 F-fluoride positron emission tomography/coronary computed tomography scanning and measurement of high-sensitivity cardiac troponin I. Patients were randomized (1:1) to receive ticagrelor 90 mg twice daily or matched placebo. The primary endpoint was troponin I concentration at 30 days in patients with increased coronary  18 F-fluoride uptake.
RESULTS


In total, 202 patients were randomized to treatment, and 191 met the pre-specified criteria for inclusion in the primary analysis. In patients with increased coronary  18 F-fluoride uptake (120 of 191), there was no evidence that ticagrelor had an effect on plasma troponin concentrations at 30 days (ratio of geometric means for ticagrelor vs. placebo: 1.11; 95% confidence interval: 0.90 to 1.36; p = 0.32). Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
CONCLUSIONS


Dual antiplatelet therapy with ticagrelor did not reduce plasma troponin concentrations in patients with high-risk coronary plaque, suggesting that subclinical plaque thrombosis does not contribute to ongoing myocardial injury in this setting. (Dual Antiplatelet Therapy to Reduce Myocardial Injury [DIAMOND]; NCT02110303).",2020,"Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
","['Patients', 'patients with high-risk coronary plaque', '202 patients were randomized to treatment, and 191 met the pre-specified criteria for inclusion in the primary analysis', 'patients with established coronary artery disease and high-risk coronary plaque', 'patients with multivessel coronary artery disease underwent coronary  18 F-fluoride positron emission tomography/coronary computed tomography scanning and measurement of high-sensitivity cardiac troponin I. Patients']","['ticagrelor', 'placebo', 'Ticagrelor', 'ticagrelor 90\xa0mg twice daily or matched placebo']","['troponin concentrations', 'Myocardial Injury', 'plasma troponin concentrations', 'troponin I concentration', 'sensitivity troponin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",202.0,0.613089,"Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
","[{'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: alastairmoss@gmail.com.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Mhairi K', 'Initials': 'MK', 'LastName': 'Doris', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jack P M', 'Initials': 'JPM', 'LastName': 'Andrews', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rachael O', 'Initials': 'RO', 'LastName': 'Forsythe', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cartlidge', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Tania A', 'Initials': 'TA', 'LastName': 'Pawade', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Daghem', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Raftis', 'Affiliation': 'Medical Research Council Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forsyth', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Steff C', 'Initials': 'SC', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lee', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Christchurch Heart Institute, University of Otago, Christchurch, New Zealand.'}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.05.023']
671,30763405,Effect of Schistosoma mansoni infection and its treatment on antibody responses to measles catch-up immunisation in pre-school children: A randomised trial.,"BACKGROUND


Schistosoma infection is associated with immune modulation that can influence responses to non-schistosome antigens. Vaccine responses may be impaired in S. mansoni-infected individuals. We investigated effects of S. mansoni infection on responses to childhood measles catch-up immunisation and of praziquantel treatment on this outcome in a randomised trial.
METHODOLOGY


The Immune Modulation and Childhood Immunisation (IMoChI) study was based in Entebbe, Uganda. Children aged 3-5 years (193 S. mansoni-infected and 61 uninfected) were enrolled. Infected children were randomised in a 1:1:1 ratio to receive praziquantel 2 weeks before, at time of, or 1 week after, measles catch-up immunisation. Plasma anti-measles IgG was measured at enrolment, 1 week and 24 weeks after measles immunisation. Primary outcomes were IgG levels and percentage of participants with levels considered protective against measles.
RESULTS


Anti-measles IgG levels increased following immunisation, but at 1 week post-immunisation S. mansoni-infected, compared to uninfected, children had lower levels of anti-measles IgG (adjusted geometric mean ratio (aGMR) 0.4 [95% CI 0.2-0.7]) and the percentage with protective antibody levels was also lower (adjusted odds ratio 0.1 [0-0.9]). Among S. mansoni-infected children, anti-measles IgG one week post-immunisation was higher among those treated with praziquantel than among those who were not yet treated (treatment before immunisation, aGMR 2.3 [1.5-4.8]; treatment at immunisation aGMR 1.8 [1.1-3.5]). At 24 weeks post-immunisation, IgG levels did not differ between the trial groups, but tended to be lower among previously-infected children who were still S mansoni stool-positive than among those who became stool-negative.
CONCLUSIONS AND SIGNIFICANCE


Our findings suggest that S. mansoni infection among pre-school children is associated with a reduced antibody response to catch-up measles immunisation, and that praziquantel treatment improves the response. S. mansoni infection may contribute to impaired vaccine responses in endemic populations; effective schistosomiasis control may be beneficial for vaccine efficacy. This should be further explored.
TRIAL REGISTRATION


ISRCTN87107592.",2019,"RESULTS


Anti-measles IgG levels increased following immunisation, but at 1 week post-immunisation S. mansoni-infected, compared to uninfected, children had lower levels of anti-measles IgG (adjusted geometric mean ratio (aGMR) 0.4","['pre-school children', 'endemic populations', 'S. mansoni-infected individuals', 'Infected children', 'Children aged 3-5 years (193 S. mansoni-infected and 61 uninfected) were enrolled']","['S. mansoni infection', 'Schistosoma mansoni infection', 'praziquantel', 'praziquantel treatment']","['percentage with protective antibody levels', 'Plasma anti-measles IgG', 'antibody responses', 'IgG levels', 'IgG levels and percentage of participants with levels considered protective against measles', 'Vaccine responses']","[{'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0036330', 'cui_str': 'Schistosoma mansoni Infection'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",,0.338325,"RESULTS


Anti-measles IgG levels increased following immunisation, but at 1 week post-immunisation S. mansoni-infected, compared to uninfected, children had lower levels of anti-measles IgG (adjusted geometric mean ratio (aGMR) 0.4","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tweyongyere', 'Affiliation': 'Department of Veterinary Pharmacy Clinical and Comparative Medicine, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Beatrice R', 'Initials': 'BR', 'LastName': 'Nassanga', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Muhwezi', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Odongo', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Swaib A', 'Initials': 'SA', 'LastName': 'Lule', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Nsubuga', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'London School of Hygiene & Tropical Medicine, Keppel Street, London United Kingdom.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Cose', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0007157']
672,32170453,Arthroscopic repair of partial-thickness articular surface rotator cuff tears: single-row transtendon technique versus double-row suture bridge (transosseous equivalent) fixation: results from a prospective randomized study.,"BACKGROUND


The purpose of this prospective study was to compare the clinical and structural findings following the arthroscopic repair of partial-thickness (exceeding 50%) articular-sided rotator cuff tears using either a single-row or a double-row suture bridge fixation.
MATERIALS AND METHODS


Fifty patients were included in this study. The patients were randomly placed into two groups: 25 underwent the single-row (Group I) and 25 a double-row suture bridge fixation (Group II). The clinical outcomes were assessed using ASES and Constant shoulder scores, both preoperatively and at the end of follow-up. The pain level was evaluated using the visual analogue scale (VAS), preoperatively, at 6 months and at the end of follow-up. All patients underwent preoperative MRI to identify the rotator cuff tear, and postoperatively at 12 months to evaluate tendon integrity.
RESULTS


The average follow-up was 32.5 months. The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II. There were no significant differences between the two groups. The average preoperative pain level decreased from 7.4 to 3 at 6 months and to 0.4 at the end of the Group I; and from 7.6 to 3 at 6 months and 0.8 in Group II. There was no significant difference between the two groups. At 12 months, the MRI assessments showed two retears in Group I (8%) and one retear in Group II (4%).
CONCLUSION


Arthroscopic repair of partial-thickness articular rotator cuff tears that exceed 50% of tendon thickness with a single-row transtendon repair or double-row suture bridge provides functional improvement and pain relief regardless of the repair technique used. There were no differences in clinical results between both techniques.
LEVEL OF EVIDENCE


Level II; prospective comparative study.",2020,The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II.,"['arthroscopic repair of partial-thickness (exceeding 50', 'Fifty patients were included in this study']","['double-row suture bridge fixation', 'Arthroscopic repair of partial-thickness articular rotator cuff tears', 'single-row transtendon technique versus double-row suture bridge (transosseous equivalent) fixation', 'articular-sided rotator cuff tears using either a single-row or a double-row suture bridge fixation', 'Arthroscopic repair of partial-thickness articular surface rotator cuff tears']","['average preoperative pain level', 'MRI assessments', 'mean Constant shoulder scores', 'pain level', 'ASES and Constant shoulder scores', 'mean ASES scores', 'visual analogue scale (VAS']","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",50.0,0.0221552,The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II.,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zafra', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Uceda', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain. ucedasan@gmail.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Muñoz-Luna', 'Affiliation': 'Reina Sofía University Hospital, Avda. Menéndez Pidal, 14004, Córdoba, Spain.'}, {'ForeName': 'Rafael C', 'Initials': 'RC', 'LastName': 'Muñoz-López', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Font', 'Affiliation': 'IMIBIC, Universidad de Córdoba, Córdoba, Spain.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03387-6']
673,32175948,McGrath Video Laryngoscope Versus Macintosh Direct Laryngoscopy for Intubation of Morbidly Obese Patients: A Randomized Trial.,"BACKGROUND


Two-thirds of the US population is considered obese and about 8% morbidly obese. Obese patients may present a unique challenge to anesthesia clinicians in airway management. Videolaryngoscopes may provide better airway visualization, which theoretically improves intubation success. However, previous work in morbidly obese patients was limited. We therefore tested the primary hypothesis that the use of McGrath video laryngoscope improves visualization of the vocal cords versus Macintosh direct laryngoscopy (Teleflex, Morrisville, NC) in morbidly obese patients.
METHODS


We enrolled 130 surgical patients, aged 18-99 years, with a body mass index ≥40 kg/m and American Society of Anaesthesiologists (ASA) physical status I-III. Patients were randomly allocated 1:1-stratified for patient's body mass index ≥50 kg/m-to McGrath video laryngoscope versus direct laryngoscopy with a Macintosh blade. The study groups were compared on glottis visualization, defined as improved Cormack and Lehane classification, with proportional odds logistic regression model.
RESULTS


McGrath video laryngoscope provided significantly better glottis visualization than Macintosh direct laryngoscopy with an estimated odds ratio of 4.6 (95% confidence interval [CI], 2.2-9.8; P < .01). We did not observe any evidence that number of intubation attempts and failed intubations increased or decreased.
CONCLUSIONS


McGrath video laryngoscope improves glottis visualization versus Macintosh direct laryngoscopy in morbidly obese patients. Large clinical trials are needed to determine whether improved airway visualization with videolaryngoscopy reduces intubation attempts and failures.",2020,"CONCLUSIONS


McGrath video laryngoscope improves glottis visualization versus Macintosh direct laryngoscopy in morbidly obese patients.","['morbidly obese patients', '130 surgical patients, aged 18-99 years, with a body mass index ≥40 kg/m and American Society of Anaesthesiologists (ASA) physical status I-III', 'Obese patients', 'Morbidly Obese Patients']","['McGrath Video Laryngoscope Versus Macintosh Direct Laryngoscopy', ""patient's body mass index ≥50 kg/m-to McGrath video laryngoscope versus direct laryngoscopy with a Macintosh blade"", 'McGrath video laryngoscope', 'Macintosh direct laryngoscopy (Teleflex, Morrisville, NC', 'videolaryngoscopy']","['number of intubation attempts and failed intubations', 'intubation success', 'glottis visualization']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2948008', 'cui_str': 'Blade'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1301877', 'cui_str': 'Failed intubation'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}]",130.0,0.176566,"CONCLUSIONS


McGrath video laryngoscope improves glottis visualization versus Macintosh direct laryngoscopy in morbidly obese patients.","[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Division of Anesthesia, Critical Care and Pain Management, Tel-Aviv Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Lauretta', 'Initials': 'L', 'LastName': 'Mosteller', 'Affiliation': 'Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Keebler', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steckner', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Chahar', 'Initials': 'C', 'LastName': 'Praveen', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': 'Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004747']
674,32166840,"Editorial Comment to OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single-dose treatment from a phase III, randomized, double-blind, placebo-controlled trial (interim analysis).",,2020,,['Japanese patients with overactive bladder and urinary incontinence'],"['placebo', 'OnabotulinumtoxinA (botulinum toxin type A']",[],"[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]",[],,0.406287,,"[{'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, Faculty of Medicine, University of Yamanashi, Chuo, Yamanashi, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14226']
675,32163927,The Effects of Interrupting Sitting Time on Affect and State Anxiety in Children of Healthy Weight and Overweight: A Randomized Crossover Trial.,"PURPOSE


Sedentary time relates to higher anxiety and more negative affect in children. This study assessed whether interrupting sitting over 3 hours is sufficient to influence state anxiety, positive affect, or negative affect, and tested weight status as a moderator.
METHODS


Analyses were the second (preplanned) purpose of a larger study. Children (N = 61; age: mean [SD] = 9.5 [1.3]; 43% healthy weight) completed 2 experimental conditions: continuous sitting for 3 hours and sitting for 3 hours interrupted with walking for 3 minutes in every 30 minutes. State anxiety, positive affect, and negative affect were reported at pretest and posttest. Multilevel models for repeated measures assessed whether experimental condition predicted posttest scores.
RESULTS


Experimental condition was unrelated to posttest state anxiety or positive affect. Weight status moderated how experimental condition influenced posttest negative affect (P = .003). Negative affect was lower in the children of healthy weight after interrupted sitting (vs continuous sitting; β = -0.8; 95% confidence interval, -1.5 to 0.0, P = .05), but it was higher in the children with overweight/obesity after interrupted sitting (vs continuous sitting; β = 0.6; 95% confidence interval, 0.0 to 1.2, P = .06).
CONCLUSIONS


Interrupting sitting acutely reduced negative affect in children of healthy weight, but not in children with overweight. Further research is needed to better understand the potential emotional benefits of sitting interruptions in youth.",2020,"Negative affect was lower in the children of healthy weight after interrupted sitting (vs continuous sitting; β = -0.8; 95% confidence interval, -1.5 to 0.0, P = .05), but it was higher in the children with overweight/obesity after interrupted sitting (vs continuous sitting; β = 0.6; 95% confidence interval, 0.0 to 1.2, P = .06).
","['Children of Healthy Weight and Overweight', 'Children (N = 61; age: mean [SD] = 9.5 [1.3]; 43% healthy weight', 'children']",['Sitting Time'],"['healthy weight', 'State Anxiety', 'State anxiety, positive affect, and negative affect']","[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.0249378,"Negative affect was lower in the children of healthy weight after interrupted sitting (vs continuous sitting; β = -0.8; 95% confidence interval, -1.5 to 0.0, P = .05), but it was higher in the children with overweight/obesity after interrupted sitting (vs continuous sitting; β = 0.6; 95% confidence interval, 0.0 to 1.2, P = .06).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zink', 'Affiliation': 'University of Southern California.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Berrigan', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Miranda M', 'Initials': 'MM', 'LastName': 'Broadney', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Faizah', 'Initials': 'F', 'LastName': 'Shareef', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Papachristopoulou', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Brady', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Shanna B', 'Initials': 'SB', 'LastName': 'Bernstein', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brychta', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Jacob D', 'Initials': 'JD', 'LastName': 'Hattenbach', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Ira L', 'Initials': 'IL', 'LastName': 'Tigner', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Courville', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Bart E', 'Initials': 'BE', 'LastName': 'Drinkard', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Smith', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Rosing', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Wolters', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Britni R', 'Initials': 'BR', 'LastName': 'Belcher', 'Affiliation': 'University of Southern California.'}]",Pediatric exercise science,['10.1123/pes.2019-0169']
676,32056318,"Editorial Comment to Comparison of single- and multiple-dose cefazolin as prophylaxis for transurethral enucleation of prostate: A multicenter, prospective, randomized controlled trial by the Japanese Research Group for Urinary Tract Infection.",,2020,,['transurethral enucleation of prostate'],['single- and multiple-dose cefazolin'],['Urinary Tract Infection'],"[{'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C1293631', 'cui_str': 'Enucleation of prostate'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",,0.0460389,,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yazawa', 'Affiliation': 'Yazawa Clinic, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Infectious Diseases and Infection Control, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14199']
677,31819385,Randomised Controlled Trial Of The Effect Of Tai Chi On Postural Balance Of People With Dementia.,"Purpose


To investigate the effect of Tai Chi exercise on postural balance among people with dementia (PWD) and the feasibility of a definitive trial on falls prevention.
Patients and methods


Dyads, comprising community-dwelling PWD and their informal carer (N=85), were randomised to usual care (n=43) or usual care plus weekly Tai Chi classes and home practice for 20 weeks (n=42). The primary outcome was the timed up and go test. All outcomes for PWD and their carers were assessed six months post-baseline, except for falls, which were collected prospectively over the six-month follow-up period.
Results


For PWD, there was no significant difference at follow-up on the timed up and go test (mean difference [MD] = 0.82, 95% confidence interval [CI] = -2.17, 3.81). At follow-up, PWD in the Tai Chi group had significantly higher quality of life (MD = 0.051, 95% CI = 0.002, 0.100, standardised effect size [ES] = 0.51) and a significantly lower rate of falls (rate ratio = 0.35, 95% CI =0.15, 0.81), which was no longer significant when an outlier was removed. Carers in the Tai Chi group at follow-up were significantly worse on the timed up and go test (MD = 1.83, 95% CI = 0.12, 3.53, ES = 0.61). The remaining secondary outcomes were not significant. No serious adverse events were related to participation in Tai Chi.
Conclusion


With refinement, this Tai Chi intervention has potential to reduce the incidence of falls and improve quality of life among community-dwelling PWD [Trial registration: NCT02864056].",2019,"Carers in the Tai Chi group at follow-up were significantly worse on the timed up and go test (MD = 1.83, 95% CI = 0.12, 3.53, ES = 0.61).","['People With Dementia', 'people with dementia (PWD', 'Patients and methods\n\n\nDyads, comprising community-dwelling PWD and their informal carer (N=85']","['Tai Chi exercise', 'Tai Chi intervention', 'Tai Chi', 'usual care (n=43) or usual care plus weekly Tai Chi classes and home practice']","['timed up and go test', 'serious adverse events', 'Postural Balance', 'postural balance', 'quality of life', 'rate of falls']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C1319882', 'cui_str': 'Informal carer'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0034380'}]",,0.117109,"Carers in the Tai Chi group at follow-up were significantly worse on the timed up and go test (MD = 1.83, 95% CI = 0.12, 3.53, ES = 0.61).","[{'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Nyman', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre, Faculty of Science and Technology, Bournemouth University, Poole House, Talbot Campus, Poole, Dorset BH12 5BB, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ingram', 'Affiliation': 'Peninsula Clinical Trials Unit, Peninsula Medical School, University of Plymouth, Plymouth, Devon PL4 8AA, UK.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'Peninsula Clinical Trials Unit, Peninsula Medical School, University of Plymouth, Plymouth, Devon PL4 8AA, UK.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Thomas', 'Affiliation': 'Bournemouth University Clinical Research Unit, Faculty of Health and Social Sciences, Bournemouth University, Royal London House, Lansdowne Campus, Bournemouth, Dorset BH1 3LT, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Bournemouth University Clinical Research Unit, Faculty of Health and Social Sciences, Bournemouth University, Royal London House, Lansdowne Campus, Bournemouth, Dorset BH1 3LT, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vassallo', 'Affiliation': 'Centre of Postgraduate Medical Research and Education, Faculty of Health and Social Sciences, Bournemouth University, Royal London House, Lansdowne Campus, Bournemouth, Dorset BH1 3LT, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Faculty of Medicine, University of Southampton, Highfield Campus, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Bibi', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre, Faculty of Science and Technology, Bournemouth University, Poole House, Talbot Campus, Poole, Dorset BH12 5BB, UK.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Barrado-Martín', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre, Faculty of Science and Technology, Bournemouth University, Poole House, Talbot Campus, Poole, Dorset BH12 5BB, UK.'}]",Clinical interventions in aging,['10.2147/CIA.S228931']
678,32160096,Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer.,"PURPOSE


Whether dosimetric advantages of proton beam therapy (PBT) translate to improved clinical outcomes compared with intensity-modulated radiation therapy (IMRT) remains unclear. This randomized trial compared total toxicity burden (TTB) and progression-free survival (PFS) between these modalities for esophageal cancer.
METHODS


This phase IIB trial randomly assigned patients to PBT or IMRT (50.4 Gy), stratified for histology, resectability, induction chemotherapy, and stage. The prespecified coprimary end points were TTB and PFS. TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs) in operated patients, quantified the extent of AE severity experienced over the duration of 1 year following treatment. The trial was conducted using Bayesian group sequential design with three planned interim analyses at 33%, 50%, and 67% of expected accrual (adjusted for follow-up).
RESULTS


This trial (commenced April 2012) was approved for closure and analysis upon activation of NRG-GI006 in March 2019, which occurred immediately prior to the planned 67% interim analysis. Altogether, 145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable. Median follow-up was 44.1 months. Fifty-one patients (30 IMRT, 21 PBT) underwent esophagectomy; 80% of PBT was passive scattering. The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0). The mean POC score was 7.6 times higher for IMRT (19.1; 7.3-32.3) versus PBT (2.5; 0.3-5.2). The posterior probability that mean TTB was lower for PBT compared with IMRT was 0.9989, which exceeded the trial's stopping boundary of 0.9942 at the 67% interim analysis. The 3-year PFS rate (50.8%  v  51.2%) and 3-year overall survival rates (44.5%  v  44.5%) were similar.
CONCLUSION


For locally advanced esophageal cancer, PBT reduced the risk and severity of AEs compared with IMRT while maintaining similar PFS.",2020,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","['145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable', 'Locally Advanced Esophageal Cancer']","['esophagectomy', 'PBT or IMRT', 'Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy', 'PBT', 'IMRT', 'proton beam therapy (PBT', 'intensity-modulated radiation therapy (IMRT']","['posterior mean TTB', 'TTB and PFS', 'total toxicity burden (TTB) and progression-free survival (PFS', '3-year PFS rate', '3-year overall survival rates', 'posterior probability that mean TTB', 'mean POC score', 'TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",145.0,0.283472,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","[{'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Hobbs', 'Affiliation': 'Quantitative Health Sciences, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Tidwell', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiudong', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Corsini', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mok', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Luyang', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Ritsuko U', 'Initials': 'RU', 'LastName': 'Komaki', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Chun', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Melenda D', 'Initials': 'MD', 'LastName': 'Jeter', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jaffer A', 'Initials': 'JA', 'LastName': 'Ajani', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Blum-Murphy', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ara A', 'Initials': 'AA', 'LastName': 'Vaporciyan', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Reza J', 'Initials': 'RJ', 'LastName': 'Mehran', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Koong', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Saumil J', 'Initials': 'SJ', 'LastName': 'Gandhi', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Wayne L', 'Initials': 'WL', 'LastName': 'Hofstetter', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Theodore S', 'Initials': 'TS', 'LastName': 'Hong', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Delaney', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02503']
679,32162420,"Is there enough naloxone to deter the diversion? Effect of concurrent administration of intravenous naloxone on opioid agonist effects of intravenous buprenorphine: A randomised, double-blind, within-subject, crossover study among opioid-dependent subjects.","INTRODUCTION AND AIMS


We aimed to evaluate and compare the effect of different intravenous doses of naloxone on reinforcing effect of intravenous buprenorphine (2 mg) in patients stabilised on sublingual buprenorphine.
DESIGN AND METHODS


This is a double-blind, within-subject, randomised, crossover study. Opioid-dependent patients, with history of intravenous drug use, stabilised on buprenorphine maintenance treatment were included after informed consent (n = 14). We administered and assessed the reinforcing effects of six test conditions: buprenorphine and naloxone co-formulation (BNX) in 4:1, 2:1 and 1:1 dose ratio (i.e. buprenorphine 2 mg + naloxone 0.5, 1 and 2 mg, respectively), buprenorphine alone (2 mg), pheniramine maleate (45.5 mg) and saline at 24 hourly intervals.
RESULTS


No significant opioid withdrawals were precipitated during any test conditions. Compared to buprenorphine alone, 4:1 BNX had comparable euphoria, drug recognition, subjective opiate sensations and drug liking (P > 0.05); 2:1 BNX condition had significantly different subjective euphoria (P = 0.001), opioid recognition (P = 0.002), subjective opioid sensations at 60 min (P = 0.027) and drug liking (P < 0.001), while 1:1 BNX had significantly different objective euphoria (P = 0.002), opioid recognition (P = 0.030), subjective opioid sensations (P < 0.001) and drug liking (P < 0.001). No significant difference was noted on sedation scores between buprenorphine alone and all three combinations of BNX.
DISCUSSION AND CONCLUSIONS


The 4:1 BNX condition did not impact the reinforcing agonist effects of buprenorphine. None of the intravenous BNX combination ratios precipitated opioid withdrawals. Findings emphasise the need for exploring more abuse deterrent mechanisms.",2020,"No significant difference was noted on sedation scores between buprenorphine alone and all three combinations of BNX.
","['Opioid-dependent patients, with history of intravenous drug use, stabilised on buprenorphine maintenance treatment were included after informed consent (n =\u200914', 'patients stabilised on sublingual buprenorphine', 'opioid-dependent subjects']","['buprenorphine alone (2 mg), pheniramine maleate', 'buprenorphine', 'naloxone', 'buprenorphine and naloxone co-formulation (BNX', 'buprenorphine 2 mg\u2009+\u2009naloxone']","['sedation scores', 'opioid recognition', 'euphoria, drug recognition, subjective opiate sensations and drug liking', 'subjective opioid sensations', 'subjective euphoria', 'drug liking', 'objective euphoria']","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0887016', 'cui_str': 'Pheniramine Maleate'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C1171048', 'cui_str': 'Buprenorphine 2 MG'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.157362,"No significant difference was noted on sedation scores between buprenorphine alone and all three combinations of BNX.
","[{'ForeName': 'Naveen K', 'Initials': 'NK', 'LastName': 'Dhagudu', 'Affiliation': 'Department of Psychiatry, Viswabharathi Medical College, Kurnool, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Ambekar', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashwani K', 'Initials': 'AK', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Raka', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}]",Drug and alcohol review,['10.1111/dar.13057']
680,32106240,"Impact of a teacher-led school handwashing program on children's handwashing with soap at school and home in Bihar, India.","Handwashing with soap is an important preventive health behavior, and yet promoting this behavior has proven challenging. We report the results of a program that trained teachers to deliver a handwashing with soap behavior change program to children in primary schools in Bihar, India. Ten intervention schools selected along with ten nearby control schools, and intervention schools received the ""School of Five"" program promoting handwashing with soap using interactive stories, games, and songs, behavioral diaries to encourage habit formation, and public commitment. Households with children aged 8-13 attending the nearby school were enrolled in the study. Handwashing with soap was measured using sticker diaries before eating and after defecation 4 weeks after the intervention was completed. Children in the treatment reported 15.1% more handwashing with soap on key occasions (35.2%) than those in the control group (20.1%) (RR: 1.77, CI: (1.22, 2.58), p = .003). There was no evidence that handwashing with soap after defecation was higher in the treatment group than the control group (RR: 1.18, CI: (0.88, 1.57), p = .265), but there was strong evidence that handwashing with soap was greater in the treatment than in the control before eating (RR: 2.68, 95% CI: (1.43, 5.03), p = .002). Rates of handwashing increased both at home (RR: 1.63, CI: 1.14, 2.32), p = .007) and at school (RR: 4.76, 95% CI: (1.65, 17.9), p = .004), though the impact on handwashing with soap at key occasions in schools was much higher than at home. Promoting handwashing with soap through teachers in schools may be an effective way to achieve behavior change at scale.",2020,"There was no evidence that handwashing with soap after defecation was higher in the treatment group than the control group (RR: 1.18, CI: (0.88, 1.57), p = .265), but there was strong evidence that handwashing with soap was greater in the treatment than in the control before eating (RR:","['to children in primary schools in Bihar, India', ""children's handwashing with soap at school and home in Bihar, India"", 'Households with children aged 8-13 attending the nearby school were enrolled in the study', 'Ten intervention schools selected along with ten nearby control schools, and intervention schools received the']","['School of Five"" program promoting handwashing with soap using interactive stories, games, and songs, behavioral diaries to encourage habit formation, and public commitment', 'handwashing with soap behavior change program', 'teacher-led school handwashing program']","['Rates of handwashing', 'handwashing with soap on key occasions', 'handwashing with soap after defecation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0872005', 'cui_str': 'Songs'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",,0.0230905,"There was no evidence that handwashing with soap after defecation was higher in the treatment group than the control group (RR: 1.18, CI: (0.88, 1.57), p = .265), but there was strong evidence that handwashing with soap was greater in the treatment than in the control before eating (RR:","[{'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Tidwell', 'Affiliation': 'Mossavar-Rahmani Center for Business and Government, Harvard Kennedy School of Government, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Anila', 'Initials': 'A', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Arathi', 'Initials': 'A', 'LastName': 'Unni', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Sheth', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Daryanani', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Population Services International, Delhi, India.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Sidibe', 'Affiliation': 'Mossavar-Rahmani Center for Business and Government, Harvard Kennedy School of Government, Cambridge, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0229655']
681,31710096,School Interventions-based Prevention of Early-Childhood Caries among 3-5-year-old children from very low socioeconomic status: Two-year randomized trial.,"OBJECTIVES


To assess the effectiveness of school-based interventions to prevent early childhood caries (ECC) among preschool children from very low socioeconomic background over a period of 2 years.
MATERIALS AND METHODS


Four hundred and twenty preschool children between the ages of 3-5 years participated in this double blind, three parallel arm clinical trial. School only interventions such as prohibition of sugary snack consumption in school, teacher supervised daily brushing using fluoridated toothpaste, and oral health education were implemented with regular follow-up at 6 months, 1, and 2 years. The study group had all three interventions, in active control-tooth brushing and oral health education, and in negative control, only oral health education. Decay at d1/d2 using World Health Organization criteria, visible plaque and gingival inflammation were assessed at all follow-ups. The value of P < 0.05 was considered significant.
RESULTS


Absolute caries risk reduction in the study group was 20 percent and 12 percent when compared to active, negative controls after 2 years. Mean caries increment in the study group was 0.4 for d1/d2, for the active control group was 0.9 and negative control 0.8. The effect of interventions to prevent ECC in each group was calculated using the Çohen's d, and the study group had a score of 0.6 when compared with active controls and 0.9 in comparison to the negative control group.
CONCLUSIONS


Prohibition of sugary snacking in school and daily supervised tooth brushing, with or without oral health education is effective in preventing ECC among preschool children with health neglect in very low-resource settings.",2020,"Mean caries increment in the study group was 0.4 for d1/d2, for the active control group was 0.9 and negative control 0.8.","['of Early-Childhood Caries among 3-5-year-old children from very low socioeconomic status', 'preschool children from very low socioeconomic background over a period of 2\u2009years', 'active control-tooth brushing and oral health education, and in negative control, only oral health education', 'Four hundred and twenty preschool children between the ages of 3-5\u2009years', 'preschool children with health neglect in very low-resource settings']","['school-based interventions', 'School Interventions-based Prevention']","['Absolute caries risk reduction', 'visible plaque and gingival inflammation', 'Mean caries increment']","[{'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0018703', 'cui_str': 'Health Education, Dental'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",420.0,0.0469511,"Mean caries increment in the study group was 0.4 for d1/d2, for the active control group was 0.9 and negative control 0.8.","[{'ForeName': 'Srinivasan Raj', 'Initials': 'SR', 'LastName': 'Samuel', 'Affiliation': 'Department of Public Health Dentistry, Saveetha Dental College, SIMATS, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Shashidhar', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal University, Manipal, Karnataka, India.'}, {'ForeName': 'Jeevika Chandrasekar', 'Initials': 'JC', 'LastName': 'Rao', 'Affiliation': 'Department of Public Health Dentistry, Thai Moogambigai Dental College and Hospital, Dr. M.G.R Educational and Research Institute University, Chennai, Tamil Nadu, India.'}]",Journal of public health dentistry,['10.1111/jphd.12348']
682,31655020,Impact of the addition of azithromycin to antimalarials used for seasonal malaria chemoprevention on antimicrobial resistance of Streptococcus pneumoniae.,"OBJECTIVE


A trial was conducted in Burkina Faso and Mali to investigate whether addition of azithromycin to the antimalarials used for seasonal malaria chemoprevention reduces mortality and hospital admissions of children. We tested the sensitivity of nasal isolates of Streptococcus pneumoniae obtained during this trial to azithromycin and other antibiotics.
METHODS


Azithromycin or placebo was administered monthly, in combination with the antimalarials used for seasonal malaria chemoprevention, for four months, over the annual malaria transmission seasons of 2014, 2015, and 2016. Nasopharyngeal swabs were collected from 2773 Burkinabe and 2709 Malian children on seven occasions: in July and December each year prior to and after drug administration, and at a final survey in early 2018. Pneumococci were isolated from nasopharyngeal swabs and tested for sensitivity to azithromycin and other antibiotics.
RESULTS


A total of 5482 samples were collected. In Burkina Faso, the percentage of pneumococcal isolates resistant to azithromycin among children who had received it increased from 4.9% (95% CI: 2.4%, 9.9%) before the intervention to 25.6% (95% CI: 17.6%, 35.7%) afterward. In Mali, the increase was from 7.6% (95% CI: 3.8%, 14.4%) to 68.5% (95% CI: 55.1%, 79.4%). The percentage of resistant isolates remained elevated (17.7% (95% CI: 11.1%, 27.1%) in Burkina Faso and 19.1% (95% CI: 13.5%, 26.3%) in Mali) among children who had received azithromycin 1 year after stopping the intervention. An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
CONCLUSION


Addition of azithromycin to the antimalarial combination used for seasonal malaria chemoprevention was associated with an increase in resistance of pneumococci to azithromycin and erythromycin, which persisted 1 year after the last administration of azithromycin.",2019,"An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
","['children', 'Nasopharyngeal swabs were collected from 2773 Burkinabe and 2709 Malian children on seven occasions: in July and December each year prior to and after drug administration, and at a final survey in early 2018']","['placebo', 'azithromycin', 'azithromycin and erythromycin', 'Azithromycin or placebo']","['resistance of pneumococci', 'percentage of resistant isolates', 'antimicrobial resistance of Streptococcus pneumoniae', 'resistance to azithromycin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab (specimen)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",,0.169842,"An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
","[{'ForeName': 'Soumeya', 'Initials': 'S', 'LastName': 'Hema-Ouangraoua', 'Affiliation': 'Centre MURAZ, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Abdoul', 'Initials': 'A', 'LastName': 'Aziz Maiga', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Nikiema', 'Initials': 'N', 'LastName': 'Frédéric', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Rakiswendé', 'Initials': 'R', 'LastName': 'Serge Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Tamboura', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Badji', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Gore-Langton', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandrahoman', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bosco Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13321']
683,30690531,"Infant Feeding Practices, Workplace Breastfeeding/Lactation Practices, and Perception of Unit/Service Support Among Primiparous Active Duty Servicewomen.","INTRODUCTION


Successful breastfeeding provides multiple health benefits to Servicewomen and their infants and has positive indirect benefits to the military. Workplace lactation support influences breastfeeding continuation after a Servicewoman's return to work.
MATERIALS AND METHODS


This study evaluated the breastfeeding practices and workplace breastfeeding support among primiparous women serving in the U.S. Army. The study was a subanalysis of a non-blinded randomized controlled trial designed to determine the effect of postpartum appointment timing (either 2-3 or 6-8 weeks after delivery) on breastfeeding rates 6 months post-delivery. Subanalysis results were obtained through a telephonic follow-up survey 5-6 months after delivery; Servicewomen were queried to assess their breastfeeding/lactation practices and perception of unit and service support.
RESULTS


Eighty of the 97 (82.5%) enrolled Servicewomen participated in the survey. Among respondents, 43.8% were still breastfeeding and 93.6% of those indicated an intent to breastfeed for a duration of 6 months or longer. Among respondents who provided feedback on their workplace, unit, and Army support for breastfeeding/lactation, only 13% reported they had access to a private room, sink, and refrigerator; 53% of respondents felt ""mostly"" or ""very"" supported by their assigned unit and 50% felt ""mostly"" or ""very"" supported by the Army.
CONCLUSION


While almost half of the respondents were still breastfeeding and planned to continue 5-6 months postpartum and the majority of respondents felt ""mostly"" or ""very"" supported in their breastfeeding by their unit and the Army, comprehensive physical support for lactation in the workplace was inconsistent. This study provides feedback to inform ongoing implementation of the existing Army breastfeeding support directive.",2019,"Among respondents, 43.8% were still breastfeeding and 93.6% of those indicated an intent to breastfeed for a duration of 6 months or longer.","['primiparous women serving in the U.S. Army', 'Primiparous Active Duty Servicewomen', 'Eighty of the 97 (82.5%) enrolled Servicewomen participated in the survey']",[],[],"[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],,0.0306714,"Among respondents, 43.8% were still breastfeeding and 93.6% of those indicated an intent to breastfeed for a duration of 6 months or longer.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Abbott', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, 9040 Fitzsimmons Dr., Tacoma, WA.'}, {'ForeName': 'Jenava', 'Initials': 'J', 'LastName': 'Carty', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, 9040 Fitzsimmons Dr., Tacoma, WA.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Batig', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, 9040 Fitzsimmons Dr., Tacoma, WA.'}]",Military medicine,['10.1093/milmed/usy356']
684,31245004,"Recruitment, retention, and training of people with type 2 diabetes as diabetes prevention mentors (DPM) to support a healthcare professional-delivered diabetes prevention program: the Norfolk Diabetes Prevention Study (NDPS).","Objective


Intensive lifestyle interventions reduce the risk of type 2 diabetes in populations at highest risk, but staffing levels are usually unable to meet the challenge of delivering effective prevention strategies to a very large at-risk population. Training volunteers with existing type 2 diabetes to support healthcare professionals deliver lifestyle interventions is an attractive option.
Methods


We identified 141 973 people at highest risk of diabetes in the East of England, screened 12 778, and randomized 1764 into a suite of type 2 diabetes prevention and screen detected type 2 diabetes management trials. A key element of the program tested the value of volunteers with type 2 diabetes, trained to act as diabetes prevention mentors (DPM) when added to an intervention arm delivered by healthcare professionals trained to support participant lifestyle change.
Results


We invited 9951 people with type 2 diabetes to become DPM and 427 responded (4.3%). Of these, 356 (83.3%) were interviewed by phone, and of these 131 (36.8%) were interviewed in person. We then appointed 104 of these 131 interviewed applicants (79%) to the role (mean age 62 years, 55% (n=57) male). All DPMs volunteered for a total of 2895 months, and made 6879 telephone calls to 461 randomized participants. Seventy-six (73%) DPMs volunteered for at least 6 months and 66 (73%) for at least 1 year.
Discussion


Individuals with type 2 diabetes can be recruited, trained and retained as DPM in large numbers to support a group-based diabetes prevention program delivered by healthcare professionals. This volunteer model is low cost, and accesses the large type 2 diabetes population that shares a lifestyle experience with the target population. This is an attractive model for supporting diabetes prevention efforts.",2019,We invited 9951 people with type 2 diabetes to become DPM and 427 responded (4.3%).,"['volunteers with type 2 diabetes, trained to act as diabetes prevention mentors (DPM', 'appointed 104 of these 131 interviewed applicants (79%) to the role (mean age 62 years, 55% (n=57) male', '9951 people with type 2 diabetes to become DPM and 427 responded (4.3', 'Discussion\n\n\nIndividuals with type 2 diabetes', 'Training volunteers with existing type 2 diabetes', '141\u2009973 people at highest risk of diabetes in the East of England, screened 12 778, and randomized 1764 into a suite of type 2 diabetes prevention and screen detected type 2 diabetes management trials', 'All DPMs volunteered for a total of 2895 months, and made 6879 telephone calls to 461 randomized participants']","['healthcare professional-delivered diabetes prevention program', 'healthcare professionals trained to support participant lifestyle change', 'Intensive lifestyle interventions']",[],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C1634619', 'cui_str': 'dpm'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0641798', 'cui_str': 'DPMS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",[],9951.0,0.0168498,We invited 9951 people with type 2 diabetes to become DPM and 427 responded (4.3%).,"[{'ForeName': 'Nikki J', 'Initials': 'NJ', 'LastName': 'Garner', 'Affiliation': 'Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pascale', 'Affiliation': 'Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Kalman', 'Initials': 'K', 'LastName': 'France', 'Affiliation': 'Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Ferns', 'Affiliation': 'Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Auckland', 'Affiliation': 'Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2018-000619']
685,31934980,Assessment of Bone Formation After Secondary Alveolar Bone Grafting With and Without Platelet-Rich Plasma Using Computer-Aided Engineering Techniques.,"The aim of this study was to analyze the newly formed bone volume (FV), 6 months after secondary alveoloplasty using iliac cancellous bone graft, with and without platelet-rich plasma (PRP). Forty patients with unilateral alveolar cleft were involved in this randomized, prospective, comparative study, with 20 patients each forming the control (group A) and PRP (group B) groups, respectively. The preoperative alveolar defect volume (DV) and the postoperative FV were automatically calculated by the computer-aided engineering software using the patients' pre and postsurgical computed tomography data. The volume of the actual bone graft (AV) was identical to the DV calculated before surgery. The bone formation ratio (BF%) was calculated as follows: BF% = (FV/AV) × 100%. The mean BF% was 42.54 ± 9.32% in group A and 46.97 ± 18.49% in group B. There was no statistically significant difference between the 2 groups for BF% (P > 0.05). The study presents a fast and accurate method for assessing the effect of PRP in alveolar grafting. However, the study found no conclusive evidence on the effect of PRP on bone growth.",2020,There was no statistically significant difference between the 2 groups for BF% (P > 0.05).,['Forty patients with unilateral alveolar cleft'],['PRP'],"['Bone Formation', 'preoperative alveolar defect volume (DV) and the postoperative FV', 'bone formation ratio (BF', 'volume of the actual bone graft (AV', 'mean BF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",40.0,0.016441,There was no statistically significant difference between the 2 groups for BF% (P > 0.05).,"[{'ForeName': 'Shuxiu', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Center for Cleft Lip and Palate Treatment, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ningbei', 'Initials': 'N', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006256']
686,32167550,Randomized Controlled Trial Comparing Landmark and Ultrasound-Guided Glossopharyngeal Nerve in Eagle Syndrome.,"INTRODUCTION


The glossopharyngeal nerve lies posterior to the internal carotid artery at the submandibular region. The primary objective of this study was to compare ultrasound-guided glossopharyngeal nerve block (UGPNB) and landmark glossopharyngeal nerve block (GPNB).
MATERIALS & METHODS


Inclusion criteria were patients with unilateral Eagle syndrome and ear pain. Group UGPNB (N = 25) received three UGPNBs at weekly intervals with 1.5 mL of 0.5% ropivacaine and 20 mg of methylprednisolone. Group GPNB (N = 26) received landmark GPNB. Pain intensity was evaluated with the numerical rating scale (NRS) before every block, 30 minutes after every block, and at one, three, and five weeks after the third block. Quality of life, assessed using the Brief Pain Inventory (BPI), and satisfaction scores were noted.
RESULTS


NRS scores before the second and third blocks and a week after were significantly lower in group UGPNB and comparable at weeks 3 and 5. NRS scores 30 minutes after every block were significantly decreased from the preblock values but were comparable between groups. In 68% of patients, a curvilinear probe delineated the internal carotid artery (ICA). Out-of-plane needle trajectory was required in 64% of patients. BPI and satisfaction scores were significantly better in the UGPNB group in the ""block"" weeks.
CONCLUSIONS


UGPNB with 1.5 mL of 0.5% ropivacaine and 20 mg of methylprednisolone injected posterior to the ICA in the submandibular region provides better pain relief for at least a week compared with an extraoral landmark technique when three weekly consecutive blocks are given. In most patients, a curvilinear probe and out-of-plane needle trajectory are most suitable for ultrasound block.",2020,"RESULTS


NRS scores before the second and third blocks and a week after were significantly lower in group UGPNB and comparable at weeks 3 and 5.","['Inclusion criteria were patients with unilateral Eagle syndrome and ear pain', 'Eagle Syndrome']","['Landmark and Ultrasound-Guided Glossopharyngeal', 'ultrasound-guided glossopharyngeal nerve block (UGPNB) and landmark glossopharyngeal nerve block (GPNB', 'UGPNB', 'landmark GPNB', 'methylprednisolone', 'ropivacaine and 20\u2009mg of methylprednisolone', 'ropivacaine']","['BPI and satisfaction scores', 'internal carotid artery (ICA', 'Quality of life, assessed using the Brief Pain Inventory (BPI), and satisfaction scores', 'pain relief', 'Pain intensity', 'NRS scores', 'numerical rating scale (NRS']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1868714', 'cui_str': 'Elongated styloid process syndrome'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394814', 'cui_str': 'Local anesthetic glossopharyngeal nerve block (procedure)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}]",,0.0637826,"RESULTS


NRS scores before the second and third blocks and a week after were significantly lower in group UGPNB and comparable at weeks 3 and 5.","[{'ForeName': 'Shanmuga', 'Initials': 'S', 'LastName': 'Sundaram', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Punj', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz370']
687,32164877,"Adjuvant  131 I-metuximab for hepatocellular carcinoma after liver resection: a randomised, controlled, multicentre, open-label, phase 2 trial.","BACKGROUND


Effective adjuvant treatment after hepatectomy for hepatocellular carcinoma (HCC) is an important area of research. Radioactive iodine ( 131 I)-labelled metuximab is a radiolabelled monoclonal antibody against the CD147 (also known as basigin or HAb18G) antigen that is expressed in HCC. We aimed to examine the role of  131 I-metuximab as an adjuvant therapy after HCC resection.
METHODS


This randomised, controlled, multicentre, open-label, phase 2 trial was done at five medical centres in China. Patients aged 18-75 years who underwent curative-intent resection of histologically confirmed HCC expressing CD147 were randomly assigned (1:1) by a computer-generated random sequence, stratified by centre, to receive either adjuvant transarterial injection of one dose of 27·75 MBq/kg  131 I-metuximab 4-6 weeks after the hepatectomy (treatment group) or no adjuvant treatment (control group). Patients and physicians were not masked to the study groups. The primary outcome was 5-year recurrence-free survival (RFS) in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT00819650.
FINDINGS


Between April 1, 2009, and Nov 30, 2012, 485 patients were screened for eligibility. 329 (68%) of these patients were excluded and 156 (32%) were randomly assigned to receive either  131 I-metuximab (n=78) or no adjuvant treatment (n=78). The median follow-up was 55·9 months (IQR 18·6-79·4). In the intention-to-treat population, the 5-year RFS was 43·4% (95% CI 33·6-55·9) in the  131 I-metuximab group and 21·7% (14·2-33·1) in the control group (hazard ratio 0·49 [95% CI 0·34-0·72]; Z=2·96, p=0·0031).  131 I-metuximab-associated adverse events occurred within the first 4 weeks in 34 (45%) of 76 patients, seven (21%) of whom had grade 3 or 4 adverse events. These adverse events were all resolved with appropriate treatment within 2 weeks of being identified.
INTERPRETATION


Adjuvant  131 I-metuximab treatment significantly improved the 5-year RFS of patients after hepatectomy for HCC tumours expressing CD147. This treatment was well tolerated by patients.
FUNDING


State Key Project on Infectious Diseases of China.",2020,"INTERPRETATION


Adjuvant  131 I-metuximab treatment significantly improved the 5-year RFS of patients after hepatectomy for HCC tumours expressing CD147.","['five medical centres in China', 'Patients aged 18-75 years who underwent curative-intent resection of histologically confirmed HCC expressing CD147', 'hepatocellular carcinoma (HCC', 'hepatocellular carcinoma after liver resection', 'Between April 1, 2009, and Nov 30, 2012, 485 patients were screened for eligibility', '329 (68%) of these patients were excluded and 156 (32%) were randomly assigned to receive either  131']","['adjuvant transarterial injection of one dose of 27·75 MBq/kg  131', 'I-metuximab (n=78) or no adjuvant treatment', 'hepatectomy (treatment group) or no adjuvant treatment (control group', 'Radioactive iodine']","['5-year recurrence-free survival (RFS', 'adverse events', '5-year RFS']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556640', 'cui_str': 'MBq'}, {'cui': 'C1722700', 'cui_str': 'metuximab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",485.0,0.168194,"INTERPRETATION


Adjuvant  131 I-metuximab treatment significantly improved the 5-year RFS of patients after hepatectomy for HCC tumours expressing CD147.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jingliang', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': ""Cell Engineering Research Center, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yefa', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jingfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatobiliary Surgery, First Affiliated and Mengchao Hepatobiliary Surgery Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xuying', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Clinical Database, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chunfang', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Clinical Laboratory, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Anfeng', 'Initials': 'A', 'LastName': 'Si', 'Affiliation': 'Department of Clinical Database, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hongyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Centre for Liver Cancer, Key Laboratory of Signaling Regulation and Targeting Therapy of Liver Cancer of the Ministry of Education of China, Shanghai Key Laboratory of Hepatobiliary Tumor Biology, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Mengchao', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China; Department of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China; Faculty of Medicine, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Area, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Cell Engineering Research Center, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China. Electronic address: shenfengehbh@sina.com.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30422-4']
688,31982648,Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial.,"INTRODUCTION


Patients with cancer often receive care that is not aligned with their personal values and goals. Serious illness conversations (SICs) between clinicians and patients can help increase a patient's understanding of their prognosis, goals and values.
METHODS AND ANALYSIS


In this study, we describe the design of a stepped-wedge cluster randomized trial to evaluate the impact of an intervention that employs machine learning-based prognostic algorithms and behavioral nudges to prompt oncologists to have SICs with patients at high risk of short-term mortality. Data are collected on documented SICs, documented advance care planning discussions, and end-of-life care utilization (emergency room and inpatient admissions, chemotherapy and hospice utilization) for patients of all enrolled clinicians.
CONCLUSION


This trial represents a novel application of machine-generated mortality predictions combined with behavioral nudges in the routine care of outpatients with cancer. Findings from the trial may inform strategies to encourage early serious illness conversations and the application of mortality risk predictions in clinical settings.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03984773.",2020,"Serious illness conversations (SICs) between clinicians and patients can help increase a patient's understanding of their prognosis, goals and values.
","['patients of all enrolled clinicians', 'patients at high risk of short-term mortality', 'outpatients with cancer', 'cancer patients']","['machine-generated mortality predictions combined with behavioral nudges', 'intervention that employs machine learning-based prognostic algorithms']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}]",[],,0.157318,"Serious illness conversations (SICs) between clinicians and patients can help increase a patient's understanding of their prognosis, goals and values.
","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Manz', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: Christopher.manz@pennmedicine.upenn.edu.'}, {'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Parikh', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America; Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, United States of America.'}, {'ForeName': 'Chalanda N', 'Initials': 'CN', 'LastName': 'Evans', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Chivers', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, PA, United States of America.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Regli', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, PA, United States of America.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bekelman', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Small', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': ""O'Connor"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Schuchter', 'Affiliation': 'Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Lawrence N', 'Initials': 'LN', 'LastName': 'Shulman', 'Affiliation': 'Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America; Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105951']
689,31678410,Study to promote innovation in rural integrated telepsychiatry (SPIRIT): Rationale and design of a randomized comparative effectiveness trial of managing complex psychiatric disorders in rural primary care clinics.,"OBJECTIVE


Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two approaches to managing PTSD and bipolar disorder in FQHCs.
INTERVENTIONS


Treatment comparators are: 1) Telepsychiatry Collaborative Care, which integrates consulting telepsychiatrists into primary care teams, and 2) Telepsychiatry Enhanced Referral, where telepsychiatrists and telepsychologists treat patients directly.
METHODS


Because Telepsychiatry Enhanced Referral is an adaptive intervention, a Sequential, Multiple Assignment, Randomized Trial design is used. Twenty-four FQHC clinics without on-site psychiatrists or psychologists are participating in the trial. The sample is patients screening positive for PTSD and/or bipolar disorder who are not already engaged in pharmacotherapy with a mental health specialist. Intervention fidelity is measured but not controlled. Patient treatment engagement is measured but not required, and intent-to-treat analysis will be used. Survey questions measure treatment engagement and effectiveness. The Short-Form 12 Mental Health Component Summary (SF-12 MCS) is the primary outcome.
RESULTS


A third (34%) of those enrolled (n = 1004) are racial/ethnic minorities, 81% are not fully employed, 68% are Medicaid enrollees, 7% are uninsured, and 62% live in poverty. Mental health related quality of life (SF-12 MCS) is 2.5 standard deviations below the national mean.
DISCUSSION


We hypothesize that patients randomized to Telepsychiatry Collaborative Care will have better outcomes than those randomized to Telepsychiatry Enhanced Referral because a higher proportion will engage in evidence-based treatment.",2020,"Mental health related quality of life (SF-12 MCS) is 2.5 standard deviations below the national mean.
","['34% of those enrolled (n\u202f=\u202f924) are racial/ethnic minorities, 82% are not fully employed, 68% are Medicaid enrollees, 7% are uninsured, and 62% live in poverty', 'Rural Integrated Telepsychiatry (SPIRIT', '1000 patients screening positive for PTSD and/or bipolar disorder who are not already engaged in pharmacotherapy with a mental health specialist', 'rural primary care clinics', 'Twenty-four FQHC clinics without on-site psychiatrists or psychologists are participating in the trial']","['Telepsychiatry Collaborative Care, which integrates consulting telepsychiatrists into primary care teams, and 2) Telepsychiatry Enhanced Referral, where telepsychiatrists and telepsychologists treat patients directly']",['Mental health related quality of life (SF-12 MCS'],"[{'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C1634625', 'cui_str': 'Percent live'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",1000.0,0.130906,"Mental health related quality of life (SF-12 MCS) is 2.5 standard deviations below the national mean.
","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fortney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA; Department of Veterans Affairs, Health Services Research and Development, Center of Innovation for Veteran-Centered and Value-Driven Care, Seattle, WA, USA. Electronic address: fortneyj@uw.edu.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Cerimele', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Pfeiffer', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA; Department of Veterans Affairs, Health Services Research and Development, Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Zielinski', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Pyne', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Department of Veterans Affairs, Health Services Research and Development, Center for Mental Healthcare and Outcomes Research, Little Rock, AR, USA.'}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Bowen', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Ferro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Danna', 'Initials': 'D', 'LastName': 'Moore', 'Affiliation': 'Social and Economic Sciences Research Center at Washington State University, Pullman, WA, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': ''}, {'ForeName': 'Florence C', 'Initials': 'FC', 'LastName': 'Fee', 'Affiliation': 'NHMH - No Health without Mental Health, San Francisco, CA, Arlington, VA, USA.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Heral', 'Affiliation': ''}, {'ForeName': 'Jode', 'Initials': 'J', 'LastName': 'Freyholtz-London', 'Affiliation': 'Wellness in the Woods, Eagle Bend, MN, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'McDonald', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jeremey', 'Initials': 'J', 'LastName': 'Mullins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hafer', 'Affiliation': 'Community Health Plan of Washington, Seattle, WA, USA.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Solberg', 'Affiliation': 'Health Partners Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Unützer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105873']
690,32162213,Health Demands Moderate the Link Between Willpower Beliefs and Physical Activity in Patients with Knee Osteoarthritis.,"BACKGROUND


Regular physical activity (PA) was found to alleviate pain and improve functioning among patients with osteoarthritis of the knee (OAK). Heightened health demands due to OAK severity, body mass index (BMI), and depressive symptoms may require self-regulatory strategies to engage in more PA. Research on willpower-the capacity to exert self-control-suggests that believing that willpower is a nonlimited rather than a limited resource predicts effective self-regulation specifically when demands are high. The present study examines the association of OAK patients' willpower beliefs with their daily PA as a function of health demands.
METHODS


To identify the moderating role of OAK severity (WOMAC), BMI, and depressive symptoms (CES-D) on the link between willpower beliefs and objectively assessed PA over a 7-day period, baseline data of a registered randomized controlled trial with 243 patients (M age  = 65.47 years, SD = 0.49) were examined in secondary analyses.
RESULTS


Moderation analyses revealed that overall positive associations of willpower beliefs with PA were further qualified by OAK severity, BMI, and depressive symptoms. When patients faced less health demands, believing that willpower is nonlimited was associated with more PA. When health demands were higher, willpower beliefs were not associated with PA.
CONCLUSION


OAK patients' willpower beliefs were associated with PA. However, facing more health demands seemed to erase this beneficial link. Improving willpower beliefs by way of intervention may help to shed more light on predictive direction and ways to overcome barriers to regular physical activity.",2020,"When health demands were higher, willpower beliefs were not associated with PA.
","['243 patients (M age \u2009=\u200965.47\xa0years, SD\u2009=\u20090.49', 'patients with osteoarthritis of the knee (OAK', 'Patients with Knee Osteoarthritis']",['Regular physical activity (PA'],"['OAK severity, BMI, and depressive symptoms', 'OAK severity (WOMAC), BMI, and depressive symptoms (CES-D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0330302', 'cui_str': 'Quercus'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0330302', 'cui_str': 'Quercus'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",243.0,0.0176824,"When health demands were higher, willpower beliefs were not associated with PA.
","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Di Maio', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany. sally.dimaio@fu-berlin.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Job', 'Affiliation': 'Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Center for Muscle and Bone Research, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Ertel', 'Affiliation': 'Department of Traumatology and Reconstructive Surgery, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Knoll', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09865-w']
691,32094219,Brief interventions for obesity when patients are asked to pay for weight loss treatment: an observational study in primary care with an embedded randomised trial.,"BACKGROUND


A brief intervention whereby GPs opportunistically facilitate an NHS-funded referral to a weight loss programme is clinically and cost-effective.
AIM


To test the acceptability of a brief intervention and attendance at a weight loss programme when GPs facilitate a referral that requires patients to pay for the service.
DESIGN AND SETTING


An observational study of the effect of a GP encouraging attendance at a weight loss programme requiring self-payment in the West Midlands from 16 October 2018 to 30 November 2018, to compare with a previous trial in England in which the service was NHS-funded.
METHOD


Sixty patients with obesity who consecutively attended primary care appointments received an opportunistic brief intervention by a GP to endorse and offer a referral to a weight loss programme at the patient's own expense. Participants were randomised to GPs who either stated the weekly monetary cost of the programme (basic cost) or who compared the weekly cost to an everyday discretionary item (cost comparison). Participants were subsequently asked to report whether they had attended a weight loss programme.
RESULTS


Overall, 47% of participants ( n  = 28) accepted the referral; 50% ( n  = 15) in the basic cost group and 43% ( n  = 13) in the cost comparison group. This was significantly less than in a previous study when the programme was NHS-funded (77%,  n  = 722/940;  P <0.0001). Most participants reported the intervention to be helpful/very helpful and appropriate/very appropriate (78%,  n  = 46/59 and 85%,  n  = 50/59, respectively) but scores were significantly lower than when the programme was NHS-funded (92%  n  = 851/922 and 88%  n  = 813/922, respectively;  P  = 0.004). One person (2%) attended the weight loss programme, which is significantly lower than the 40% of participants who attended when the programme was NHS-funded ( P <0.0001).
CONCLUSION


GP referral to a weight loss programme that requires patients to pay rather than offering an NHS-funded programme is acceptable; however, it results in almost no attendance.",2020,"Most participants reported the intervention to be helpful/very helpful and appropriate/very appropriate (78%,  n  = 46/59 and 85%,  n  = 50/59, respectively) but scores were significantly lower than when the programme was NHS-funded (92%  n  = 851/922 and 88%  n  = 813/922, respectively;  P  = 0.004).","['encouraging attendance at a weight loss programme requiring self-payment in the West Midlands from 16 October 2018 to 30 November 2018, to compare with a previous trial in England in which the service was NHS-funded', 'Sixty patients with obesity who consecutively attended primary care appointments received an', 'Participants were subsequently asked to report whether they had attended a weight loss programme']","['opportunistic brief intervention by a GP to endorse and offer a referral to a weight loss programme', 'GP', 'GPs who either stated the weekly monetary cost of the programme (basic cost) or who compared the weekly cost to an everyday discretionary item (cost comparison']",['weight loss programme'],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0454882', 'cui_str': 'West Midlands (geographic location)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1278502', 'cui_str': 'Appointment received'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3853050', 'cui_str': 'Cost Comparison'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",60.0,0.0622502,"Most participants reported the intervention to be helpful/very helpful and appropriate/very appropriate (78%,  n  = 46/59 and 85%,  n  = 50/59, respectively) but scores were significantly lower than when the programme was NHS-funded (92%  n  = 851/922 and 88%  n  = 813/922, respectively;  P  = 0.004).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Tudor', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford; National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford; National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Manoharan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford; National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X708797']
692,31838258,Program to improve mobility in aging (PRIMA) study: Methods and rationale of a task-oriented motor learning exercise program.,"Walking difficulty is a common and costly problem in older adults. A potentially important yet unaddressed strategy to enhance walking ability through exercise intervention is to add a timing and coordination component in gait training (i.e. task specific timing and coordination exercise intervention) to the usual strength, endurance, and flexibility training. We describe the methods and rationale of a randomized single-blind, physical therapist supervised, exercise intervention trial to compare the effects of a standard strength, endurance, and flexibility program to a standard plus timing and coordination program in community-dwelling older adults walking slower than the desired gait speed of 1.2 m/s. Exercise sessions are twice weekly for 12 weeks. Participants are assessed at baseline, 12 weeks (post intervention), 24 weeks and 36 weeks. The primary outcome is gait speed, secondary outcomes represent components of the interventions (strength, endurance, flexibility, timing and coordination), and tertiary outcomes are measure of activity and participation (Late Life Function and Disability Instrument and physical activity). The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time. The information derived from this project will provide valuable insight into the prevention and management of walking difficulty, which is so common in older Americans.",2020,"The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time.","['older Americans', 'older adults', 'community-dwelling older adults walking slower than the desired gait speed of 1.2\u202fm/s']","['standard strength, endurance, and flexibility program to a standard plus timing and coordination program', 'task-oriented motor learning exercise program']","['gait speed, secondary outcomes represent components of the interventions (strength, endurance, flexibility, timing and coordination), and tertiary outcomes are measure of activity and participation (Late Life Function and Disability Instrument and physical activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.040983,"The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States. Electronic address: jbrach@pitt.edu.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Gil', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Neurology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kriska', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Rakie', 'Initials': 'R', 'LastName': 'Cham', 'Affiliation': 'Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105912']
693,30859755,Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study.,"Frailty is associated with increased mortality both before and after liver transplantation (LT). There are no standardized exercise programs, in particular home-based exercise programs (HBEPs), for patients awaiting LT. The aim was to investigate the feasibility of such a program in patients awaiting LT. Patients were randomly selected from the Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises. Feasibility was based on patient eligibility (≥66% of waiting list), target recruitment (≥90% of n = 20), safety (no related serious adverse events), and adherence (≥66% adherence to 6-week HBEP). Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS]) were taken at baseline and at 6 and 12 weeks. 18 patients (50% male; median age, 55 years) were recruited. All domains of the study feasibility criteria were met. ISWT improved after 6 weeks (50 m; P ≤ 0.01) and 12 weeks (210 m; P ≤ 0.01), despite withdrawal of the telephone health calls. Similarly, improvements were seen in ADS (2700/day; P ≤ 0.01) and the SPPBT (2.5; P = 0.02) after 12 weeks. There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04). In conclusion, a 12-week HBEP, incorporating both easy-to-apply resistance and aerobic exercises, is safe and feasible in patients awaiting LT. Measures of aerobic and functional capacity demonstrate trends toward improvement that warrant further investigation in a randomized controlled trial.",2019,"There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04).","['patients awaiting LT', '18 patients (50% male; median age, 55 years) were recruited', 'Patients Awaiting Liver Transplantation']","['Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises', 'Home-Based Exercise']","['ISWT', 'Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS', 'HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.0341438,"There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04).","[{'ForeName': 'Felicity Rhian', 'Initials': 'FR', 'LastName': 'Williams', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vallance', 'Affiliation': 'Department of Physiotherapy, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faulkner', 'Affiliation': 'Department of Anaesthesia, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Towey', 'Affiliation': 'Department of Dietetics, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Durman', 'Affiliation': 'Advanced Personal Trainer, Virgin Active Solihull, Solihull, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kyte', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Elsharkawy', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Thamara', 'Initials': 'T', 'LastName': 'Perera', 'Affiliation': 'Liver Transplant Unit, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Holt', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Lord', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Matthew James', 'Initials': 'MJ', 'LastName': 'Armstrong', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25442']
694,30737046,Malaria early in the first pregnancy: Potential impact of iron status.,"BACKGROUND & AIMS


Low iron stores may protect from malaria infection, therefore improving iron stores in early pregnancy in line with current recommendations could increase malaria susceptibility. To test this hypothesis we compared iron biomarkers and red cell indices in nulliparae and primigravidae who participated in a randomized controlled trial of long-term weekly iron supplementation.
METHODS


Cross-sectional and longitudinal data analysis from a randomized controlled trial of long-term weekly iron supplementation in rural Burkina Faso. Malaria parasitaemia was monitored and biomarkers and red cell indices measured at study end-points: plasma ferritin, transferrin receptor (sTfR), zinc protoporphyrin, hepcidin, sTfR/log 10  ferritin ratio, body iron, haemoglobin, red cell distribution width; mean corpuscular haemoglobin concentration/volume, and C-reactive protein. Correlation coefficients between biomarkers and red cell indices were determined. A regression correction approach based on ferritin was used to estimate iron body stores, allowing for inflammation. Body iron differences were compared between nulliparae and primigravidae, and the association determined of iron biomarkers and body iron stores with malaria.
RESULTS


Iron and haematological indices of 972 nulliparae (mean age 16.5 years) and 314 primigravidae (median gestation 18 weeks) were available. Malaria prevalence was 54.0% in primigravidae and 41.8% in nulliparae (relative risk 1.28, 95% CI 1.13-1.45, P < 0.001), anaemia prevalence 69.7% and 43.4% (P < 0.001), and iron deficient erythropoiesis (low body iron) 8.0% and 11.7% (P = 0.088) respectively. Unlike other biomarkers the sTfR/log 10  ferritin ratio showed no correlation with inflammation as measured by CRP. Most biomarkers indicated reduced iron deficiency in early pregnancy, with the exception of haemoglobin. Body iron increased by 0.6-1.2 mg/kg in early gestation, did not differ by malaria status in nulliparae, but was higher in primigravidae with malaria (6.5 mg/kg versus 5.0 mg/kg; relative risk 1.53, 95% CI 0.67-2.38, P < 0.001).
CONCLUSION


In primigravidae, early pregnancy haemoglobin was not a good indicator of requirement for iron supplementation, which could be detrimental given the association of better iron status with increased malaria infection.
TRIAL REGISTRATION


clinicaltrials.gov:NCT01210040. Until placed in a public repository, data relating to the current study can be requested from the corresponding author and will be made available following an end user data agreement and sponsor approval.",2020,"Body iron increased by 0.6-1.2 mg/kg in early gestation, did not differ by malaria status in nulliparae, but was higher in primigravidae with malaria (6.5 mg/kg versus 5.0 mg/kg; relative risk 1.53, 95% CI 0.67-2.38, P ","['nulliparae and primigravidae who participated', 'rural Burkina Faso', 'Iron and haematological indices of 972 nulliparae (mean age 16.5 years) and 314 primigravidae (median gestation 18 weeks) were available']",['long-term weekly iron supplementation'],"['Malaria parasitaemia', 'iron deficient erythropoiesis', 'plasma ferritin, transferrin receptor (sTfR), zinc protoporphyrin, hepcidin, sTfR', 'malaria status in nulliparae', 'Malaria prevalence', 'anaemia prevalence', 'log 10  ferritin ratio, body iron, haemoglobin, red cell distribution width; mean corpuscular haemoglobin concentration/volume, and C-reactive protein', 'Body iron']","[{'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0014819', 'cui_str': 'Erythropoiesis'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0034845', 'cui_str': 'Transferrin Receptor'}, {'cui': 'C0078791', 'cui_str': 'zinc protoporphyrin'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0427460', 'cui_str': 'Red Cell Distribution Width'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.364863,"Body iron increased by 0.6-1.2 mg/kg in early gestation, did not differ by malaria status in nulliparae, but was higher in primigravidae with malaria (6.5 mg/kg versus 5.0 mg/kg; relative risk 1.53, 95% CI 0.67-2.38, P ","[{'ForeName': 'Salou', 'Initials': 'S', 'LastName': 'Diallo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso. Electronic address: saloudiallo89@yahoo.fr.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre (MAHSC), Oxford Road, University of Manchester, Manchester, M139PL, UK. Electronic address: steve.roberts@manchester.ac.uk.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gies', 'Affiliation': 'Department of Biomedical Sciences, Prince Leopold Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium; Medical Mission Institute, Würzburg, Germany. Electronic address: sabine.gies@medmissio.de.'}, {'ForeName': 'Toussaint', 'Initials': 'T', 'LastName': 'Rouamba', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso. Electronic address: rouambatoussaint@gmail.com.'}, {'ForeName': 'Dorine W', 'Initials': 'DW', 'LastName': 'Swinkels', 'Affiliation': 'Department of Laboratory Medicine (TLM 830), Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB, Nijmegen, the Netherlands; Hepcidinanalysis.com, Geert Grooteplein 10 (830), 6525 GA, Nijmegen, the Netherlands. Electronic address: Dorine.Swinkels@radboudumc.nl.'}, {'ForeName': 'Anneke J', 'Initials': 'AJ', 'LastName': 'Geurts-Moespot', 'Affiliation': 'Hepcidinanalysis.com, Geert Grooteplein 10 (830), 6525 GA, Nijmegen, the Netherlands. Electronic address: Anneke.Geurts-Moespot@radboudumc.nl.'}, {'ForeName': 'Sayouba', 'Initials': 'S', 'LastName': 'Ouedraogo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso. Electronic address: dm_osayouba@yahoo.fr.'}, {'ForeName': 'Georges Anicet', 'Initials': 'GA', 'LastName': 'Ouedraogo', 'Affiliation': 'Université polytechnique de Bobo Dioulasso, PO Box 1091, Burkina Faso. Electronic address: oga@fasonet.bf.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso. Electronic address: halidoutinto@gmail.com.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Brabin', 'Affiliation': 'Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L35QA, England, UK; Institute of Infection and Global Health, University of Liverpool, UK; Global Child Health Group, Academic Medical Centre, University of Amsterdam, the Netherlands. Electronic address: b.j.brabin@liverpool.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.01.016']
695,31950979,"Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial.","Importance


It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock.
Objective


To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock.
Design, Setting, and Participants


Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019.
Interventions


Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days.
Main Outcomes and Measures


The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality.
Results


Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was -0.6 hours (95% CI, -8.3 to 7.2 hours; P = .83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported.
Conclusions and Relevance


In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT03333278.",2020,"No serious adverse events were reported.
","['Patients With Septic Shock', '216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63', '10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock', 'The first patient was enrolled on May 8, 2018, and the last on July 9, 2019', 'patients with septic shock']","['intravenous vitamin C, hydrocortisone, and thiamine', 'intravenous hydrocortisone', 'hydrocortisone alone', 'vitamin C, hydrocortisone, and thiamine', 'intravenous vitamin C', 'thiamine', 'hydrocortisone', 'Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone']","['Time alive and vasopressor free', 'Ninety-day mortality', 'duration of time alive and free of vasopressor administration up to day 7', 'serious adverse events', 'duration of time alive and free of vasopressor administration', 'Time Alive and Free of Vasopressor Support', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",216.0,0.416565,"No serious adverse events were reported.
","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Frei', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Udy', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Edney', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Hunt', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Judd', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thummaporn', 'Initials': 'T', 'LastName': 'Naorungroj', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Forbes', 'Initials': 'F', 'LastName': 'McGain', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Hudson', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Wisam', 'Initials': 'W', 'LastName': 'Al-Bassam', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dhiraj Bhatia', 'Initials': 'DB', 'LastName': 'Dwivedi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Peppin', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'McCracken', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Orosz', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.22176']
696,32162167,Pilot Study of an Online Self-Directed Learning Module for Medical Decision-Making Capacity.,"OBJECTIVE


This study assessed the impact of an online, self-directed learning module on medical student knowledge and attitudes regarding decision-making capacity.
METHODS


The authors created a 15-min didactic video on decision-making capacity and sorted medical students on the psychiatry clerkship to teaching as usual or teaching as usual plus watching the video. The authors assessed student knowledge about and attitudes toward decisional capacity assessment using a pre/posttest design.
RESULTS


Thirty-eight students completed the study (24% of all psychiatry clerkship students in one academic year). Students who watched the video (n = 14) achieved higher scores on the posttest compared with students who did not watch the video (n = 24) (90% vs 84% on general knowledge and case examples), though this difference was small and not statistically significant. The degree of improvement from pretest to posttest was higher for students who watched the video but did not reach statistical significance.
CONCLUSIONS


Overall, students found the online teaching module to be a helpful augmentation strategy for learning decisional capacity assessment. The authors incorporated student feedback and additional review to create an enhanced video, which is available on ADMSEP's Clinical Simulation Initiative website.",2020,"The degree of improvement from pretest to posttest was higher for students who watched the video but did not reach statistical significance.
",['Thirty-eight students completed the study (24% of all psychiatry clerkship students in one academic year'],"['online, self-directed learning module', 'Online Self-Directed Learning Module', 'didactic video']",['student knowledge about and attitudes toward decisional capacity assessment'],"[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0255723,"The degree of improvement from pretest to posttest was higher for students who watched the video but did not reach statistical significance.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ryznar', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. elizabeth.ryznar.md@gmail.com.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Hamaoka', 'Affiliation': 'Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'R Brett', 'Initials': 'RB', 'LastName': 'Lloyd', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}]",Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry,['10.1007/s40596-020-01215-y']
697,32143732,"The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain.","BACKGROUND


Shoulder impingement syndrome is one of the most common causes of shoulder pain, accounting for approximately 30% of all shoulder pain. Approximately 35% of patients with shoulder impingement syndrome are refractory to conservative treatment. For patients who fail conservative treatment, there is no established treatment to successfully treat their chronic pain. Prior randomized control trials have demonstrated efficacy for the use of a single lead intramuscular peripheral nerve stimulation of the axillary nerve at the motor points of the deltoid muscle for treatment of hemiplegic shoulder pain. This is the first controlled trial to utilize the same novel technology to treat shoulder impingement syndrome outside of the stroke population.
METHODS


This is a dual-site, placebo-controlled, double-blinded, randomized control trial. Participants will be randomized to two treatment groups. The intervention group will be treated with active peripheral nerve stimulation of the axillary nerve of the affected shoulder and the control group will be treated with sham peripheral nerve stimulation of the axillary nerve of the affected shoulder. Both groups will receive a standardized exercise therapy program directed by a licensed therapist.
DISCUSSION


This study protocol will allow the investigators to determine if this novel, non-pharmacologic treatment of shoulder pain can demonstrate the same benefit in musculoskeletal patients which has been previously demonstrated in the stroke population.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03752619. Registered on 26 November 2018.",2020,Prior randomized control trials have demonstrated efficacy for the use of a single lead intramuscular peripheral nerve stimulation of the axillary nerve at the motor points of the deltoid muscle for treatment of hemiplegic shoulder pain.,"['chronic shoulder pain', 'hemiplegic shoulder pain', 'musculoskeletal patients']","['standardized exercise therapy program directed by a licensed therapist', 'active peripheral nerve stimulation of the axillary nerve of the affected shoulder and the control group will be treated with sham peripheral nerve stimulation of the axillary nerve of the affected shoulder', 'axillary nerve stimulation', 'placebo']",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.506571,Prior randomized control trials have demonstrated efficacy for the use of a single lead intramuscular peripheral nerve stimulation of the axillary nerve at the motor points of the deltoid muscle for treatment of hemiplegic shoulder pain.,"[{'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Cleland', 'Affiliation': 'MetroHealth Rehabilitation Institute, MetroHealth System, 4229 Pearl Rd, N5-27, Cleveland, OH, 44109, USA.'}, {'ForeName': 'Nitin B', 'Initials': 'NB', 'LastName': 'Jain', 'Affiliation': 'Vanderbilt University Medical Center, 3319 West End Ave, Nashville, TN, 37203, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': 'MetroHealth Rehabilitation Institute, MetroHealth System, 4229 Pearl Rd, N5-27, Cleveland, OH, 44109, USA.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Hansen', 'Affiliation': 'MetroHealth Rehabilitation Institute, MetroHealth System, 4229 Pearl Rd, N5-27, Cleveland, OH, 44109, USA.'}, {'ForeName': 'Terri Z', 'Initials': 'TZ', 'LastName': 'Hisel', 'Affiliation': 'MetroHealth Rehabilitation Institute, MetroHealth System, 4229 Pearl Rd, N5-27, Cleveland, OH, 44109, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Gunzler', 'Affiliation': 'Center for Healthcare Research and Policy, MetroHealth System, 2500 MetroHealth Dr., Cleveland, OH, 44109, USA.'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Whitehair', 'Affiliation': 'MetroHealth Rehabilitation Institute, MetroHealth System, 4229 Pearl Rd, N5-27, Cleveland, OH, 44109, USA.'}, {'ForeName': 'Chong H', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'MetroHealth Rehabilitation Institute, MetroHealth System, 4229 Pearl Rd, N5-27, Cleveland, OH, 44109, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Wilson', 'Affiliation': 'MetroHealth Rehabilitation Institute, MetroHealth System, 4229 Pearl Rd, N5-27, Cleveland, OH, 44109, USA. rwilson@metrohealth.org.'}]",Trials,['10.1186/s13063-020-4174-x']
698,31965649,"Comparison of single- and multiple-dose cefazolin as prophylaxis for transurethral enucleation of prostate: A multicenter, prospective, randomized controlled trial by the Japanese Research Group for Urinary Tract Infection.","OBJECTIVES


To compare the optimal administration period of antimicrobial prophylaxis in patients undergoing transurethral enucleation of the prostate for benign prostatic hyperplasia.
METHODS


We carried out a randomized controlled trial to compare the differences in incidence of perioperative genitourinary tract infection between single and multiple (3 days) administrations of cefazolin for transurethral enucleation of the prostate in benign prostatic hyperplasia patients without pyuria or bacteriuria between January 2015 and December 2018.
RESULTS


This multicenter randomized controlled trial included 203 patients who underwent a transurethral enucleation of the prostate procedure. All received antimicrobial prophylaxis, and were randomized into those who received single-dose (n = 101) or multiple-dose (n = 102) therapy. The rate of genitourinary tract infection after transurethral enucleation of the prostate for all patients was 1.5%, whereas that in the single-dose group was 1.0% and in the multiple-dose group was 2.0%, which were not significantly different (P = 1.00).
CONCLUSIONS


A single dose of antimicrobial prophylaxis as a prophylactic antibacterial drug is sufficient for patients undergoing transurethral enucleation of the prostate who do not have presurgical pyuria or bacteriuria.",2020,"The rate of genitourinary tract infection after transurethral enucleation of the prostate for all patients was 1.5%, whereas that in the single-dose group was 1.0% and in the multiple-dose group was 2.0%, which were not significantly different (P = 1.00).
","['patients undergoing transurethral enucleation of the prostate for benign prostatic hyperplasia', 'transurethral enucleation of prostate', 'patients undergoing transurethral enucleation of the prostate who do not have presurgical pyuria or bacteriuria', '203 patients who underwent a transurethral enucleation of the prostate procedure', 'benign prostatic hyperplasia patients without pyuria or bacteriuria between January 2015 and December 2018']","['cefazolin', 'single- and multiple-dose cefazolin', 'antimicrobial prophylaxis']","['Urinary Tract Infection', 'rate of genitourinary tract infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C1293631', 'cui_str': 'Enucleation of prostate'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0034359', 'cui_str': 'Pyuria'}, {'cui': 'C0004659', 'cui_str': 'Bacteriuria'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C1279247', 'cui_str': 'Genitourinary tract infection'}]",203.0,0.0824334,"The rate of genitourinary tract infection after transurethral enucleation of the prostate for all patients was 1.5%, whereas that in the single-dose group was 1.0% and in the multiple-dose group was 2.0%, which were not significantly different (P = 1.00).
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Togo', 'Affiliation': 'Department of Urology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Fukui', 'Affiliation': 'Department of Urology, Takarazuka City Hospital, Takarazuka, Hyogo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Department of Urology, Nishinomiya Municipal Central Hospital, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Sojun', 'Initials': 'S', 'LastName': 'Kanamaru', 'Affiliation': 'Department of Urology, Kobe City Nishi-Kobe Medical Center, Kobe, Hyogo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Urology, Kobe City Nishi-Kobe Medical Center, Kobe, Hyogo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Okayama, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Sadahira', 'Affiliation': 'Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Okayama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Urology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Urology, University of Occupational and Environmental Health Japan, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Hamasuna', 'Affiliation': 'Department of Urology, Federation of National Public Services Affiliated Personal Mutual Aid Associations, Shin-Kokura Hospital, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Kiyohito', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Urology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Takai', 'Affiliation': 'Department of Urology, Kizawa Memorial Hospital, Minokamo, Gifu, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Department of Urology, Gifu University Hospital, Gifu, Gifu, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Yasuda', 'Affiliation': 'Center for Nutrition Support and Infection Control, Gifu University Hospital, Gifu, Gifu, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kokura', 'Affiliation': 'Department of Urology, Takarazuka City Hospital, Takarazuka, Hyogo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Kondoh', 'Affiliation': 'Department of Urology, Kyowakai Kyoritsu Hospital, Kawanishi, Hyogo, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Takiuchi', 'Affiliation': 'Department of Urology, Nishinomiya Municipal Central Hospital, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Urology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14181']
699,32068463,Hemodynamic and perceptual responses to blood flow-restricted exercise among patients undergoing dialysis.,"End-stage kidney disease is associated with reduced exercise capacity, muscle atrophy, and impaired muscle function. While these may be improved with exercise, single modalities of exercise do not traditionally elicit improvements across all required physiological domains. Blood flow-restricted exercise may improve all of these physiological domains with low intensities traditionally considered insufficient for these adaptions. Investigation of this technique appeals, but is yet to be evaluated, in patients undergoing dialysis. With the use of a progressive crossover design, 10 satellite patients undergoing hemodialysis underwent three exercise conditions over 2 wk: two bouts (10 min) of unrestricted cycling during two consecutive hemodialysis sessions ( condition 1 ), two bouts of cycling with blood flow restriction while off hemodialysis on 2 separate days ( condition 2 ), and two bouts of cycling with blood flow restriction during two hemodialysis sessions ( condition 3 ). Outcomes included hemodynamic responses (heart rate and blood pressure) throughout all sessions, participant-perceived exertion and discomfort on a Borg scale, and evaluation of ultrafiltration rates and dialysis adequacy (Kt/V) obtained post hoc. Hemodynamic responses were consistent regardless of condition. Significant increases in heart rate, systolic blood pressure, and mean arterial blood pressure ( P  < 0.05) were observed postexercise followed by a reduction in blood pressures during the 60-min recovery (12, 5, and 11 mmHg for systolic, diastolic, and mean arterial pressures, respectively). Blood pressures returned to predialysis ranges following the recovery period. Blood flow restriction did not affect ultrafiltration achieved or Kt/V. Hemodynamic safety and tolerability of blood flow restriction during aerobic exercise on hemodialysis is comparable to standard aerobic exercise.",2020,"Significant increases in heart rate, systolic blood pressure and mean arterial blood pressure (P<0.05) were observed post-exercise, followed by a reduction in blood pressures during the 60 min recovery (12 mmHg, 5 mmHg and 11 mm Hg for systolic, diastolic and mean arterial pressures, respectively).","['Dialysis Patients', 'dialysis patients']",[],"['exercise capacity, muscle atrophy and impaired muscle function', 'blood pressures', 'haemodynamic responses (heart rate, blood pressure) throughout all sessions, participant-perceived exertion and discomfort on a Borg scale, and evaluation of ultrafiltration rates and Kt/V obtained  post-hoc ', 'Blood flow restriction', 'heart rate, systolic blood pressure and mean arterial blood pressure', 'Haemodynamic and Perceptual Responses to Blood Flow', 'Blood pressures', 'Haemodynamic responses']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026846', 'cui_str': 'Atrophy, Muscle'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",,0.0333491,"Significant increases in heart rate, systolic blood pressure and mean arterial blood pressure (P<0.05) were observed post-exercise, followed by a reduction in blood pressures during the 60 min recovery (12 mmHg, 5 mmHg and 11 mm Hg for systolic, diastolic and mean arterial pressures, respectively).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Clarkson', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brumby', 'Affiliation': 'Department of Renal Medicine, Eastern Health Clinical School, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steve F', 'Initials': 'SF', 'LastName': 'Fraser', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'McMahon', 'Affiliation': 'Department of Renal Medicine, Eastern Health Clinical School, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Bennett', 'Affiliation': 'Medical and Clinical Affairs, Satellite Healthcare, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Warmington', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00576.2019']
700,31964678,FACT: a randomised controlled trial to assess the feasibility of QbTest in the assessment process of attention deficit hyperactivity disorder (ADHD) for young people in prison-a feasibility trial protocol.,"INTRODUCTION


The prevalence of attention deficit hyperactivity disorder (ADHD) within the Children and Young People Secure Estate (CYPSE) is much higher than seen in the general population. To make a diagnosis of ADHD, clinicians draw on information from multiple sources, including parents and teachers. However, obtaining these is particularly difficult for young people in the secure estate. There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD. The objective of this study is to assess the feasibility and acceptability of QbTest in the assessment of ADHD within the CYPSE.
METHODS AND ANALYSIS


A single-centre parallel group feasibility randomised controlled trial will be conducted. Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD will be randomised to the intervention arm (n=30; QbTest plus usual care) or control arm (n=30; usual care). Primary analyses will be descriptive and a process evaluation will be conducted to assess the contexts involved in implementing the intervention. Interviews will be conducted to explore acceptability and thematic analysis will be used to analyse the data.
ETHICS AND DISSEMINATION


This study was approved by National Health Service Wales research ethics committee 3 (18/WA/0347) on 15 February 2019. The findings will be published in peer-reviewed journals, presented at relevant conferences and disseminated to the public via summaries cocreated with our patient and public involvement group.
TRIAL REGISTRATION NUMBER


ISRCTN17402196.",2020,There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD.,['Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD'],['FACT'],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",[],[],60.0,0.166984,There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lennox', 'Affiliation': 'Division of Psychology and Mental Health, The University of Manchester, Manchester, UK charlotte.lennox@manchester.ac.uk.'}, {'ForeName': 'Charlotte Lucy', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Lesley-Anne', 'Initials': 'LA', 'LastName': 'Carter', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Beresford', 'Affiliation': 'Social Policy Research Unit, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Department of Clinical and Forensic Psychology, Psychology Services Limited, London, UK.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Kraam', 'Affiliation': 'Child and Adolescent Mental Health Service, Rotherham Doncaster and South Humber Mental Health NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Wilkinson-Cunningham', 'Affiliation': 'Research and Development, Leeds Community Healthcare NHS Trust, Leeds, UK.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Reeves', 'Affiliation': 'Medical School, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Prathiba', 'Initials': 'P', 'LastName': 'Chitsabesan', 'Affiliation': 'Child and Adolescent Mental Health Service, Pennine Care NHS Foundation Trust, Ashton-under-Lyne, Lancashire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035519']
701,30019617,Association of Acute Increase in Plasma Neurofilament Light with Repetitive Subconcussive Head Impacts: A Pilot Randomized Control Trial.,"The purpose of the study was to examine an association of repetitive subconcussive head impacts with changes in plasma neurofilament light (NF-L) levels following 10 bouts of controlled soccer heading. In this randomized control trial, 37 healthy adult soccer players were randomly assigned into either a heading (n = 19) or kicking-control group (n = 18). The heading group executed 10 headers with soccer balls projected at a velocity of 25 mph over 10 min. Plasma samples were obtained at pre-heading baseline, 0 h, 2 h, and 24 h post-heading. The kicking-control group followed the same protocol with 10 kicks. Plasma NF-L was measured using ultrasensitive single-molecule array technology. Data from 34 subjects were eligible for analysis (heading n = 18 and kicking n = 16). Ten subconcussive head impacts induced a gradual increase in plasma NF-L expression for the heading group (β = 0.0297, standard error [SE] = 0.01, p = 0.0049), whereas there was no significant time effect for the kicking-control group. A follow-up analysis revealed that a significant difference appeared at 24 h post-heading (3.68 ± 0.30 pg/mL) compared with pre-heading (3.12 ± 0.29 pg/mL, p = 0.0013; Cohen's d = 1.898). At the 24 h post-heading time-point, the plasma NF-L level for the heading group was significantly higher than that of the kicking-control group with an estimated mean difference of 0.66 pg/mL (SE = 0.22, p = 0.0025). The data suggest that the increased level of plasma NF-L was driven by repetitive subconcussive head impacts and required longer than 2 h after the head impacts for the increase to be detected. Plasma NF-L levels may serve as an objective marker to monitor acute axonal burden from subconcussive head impacts.",2019,"At the 24 h post-heading time-point, the plasma NF-L level for the heading group was significantly higher than that of the kicking-control group with an estimated mean difference of 0.66 pg/mL (SE = 0.22, p = 0.0025).","['37 healthy adult soccer players', '10 bouts of controlled soccer heading', '34 subjects were eligible for analysis (heading n\u2009=\u200918 and kicking n\u2009=\u200916']",['kicking-control group'],"['plasma NF-L expression', 'level of plasma NF-L', 'Plasma NF-L levels', 'plasma NF-L level', 'Plasma NF-L', 'plasma neurofilament light (NF-L) levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0018670', 'cui_str': 'Head'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]",37.0,0.113486,"At the 24 h post-heading time-point, the plasma NF-L level for the heading group was significantly higher than that of the kicking-control group with an estimated mean difference of 0.66 pg/mL (SE = 0.22, p = 0.0025).","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wirsching', 'Affiliation': '1 Department of Kinesiology, Indiana University , Bloomington, Indiana.'}, {'ForeName': 'Zhongxue', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': '2 Department of Epidemiology and Biostatistics, School of Public Health, Indiana University , Bloomington, Indiana.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Bevilacqua', 'Affiliation': '1 Department of Kinesiology, Indiana University , Bloomington, Indiana.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Huibregtse', 'Affiliation': '1 Department of Kinesiology, Indiana University , Bloomington, Indiana.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kawata', 'Affiliation': '1 Department of Kinesiology, Indiana University , Bloomington, Indiana.'}]",Journal of neurotrauma,['10.1089/neu.2018.5836']
702,30793203,Effect of 7 Months of Physical Training and Military Routine on the Bone Mass of Young Adults.,"INTRODUCTION


Physical activity (PA) has a great influence on bone mineral density (BMD) and bone mineral content (BMC), however longitudinal studies that seek to relate bone mass to physical activity are scarce and have a small sample size. The aim of this study was to evaluate and compare the effect of 7 months of military physical training (MPT), impact sports (IS), and swimming in the bone mass of young military adults.
MATERIALS AND METHODS


A prospective study was conducted with 213 military school students (male and aged 19.2 ± 1.2 years) divided into three groups: MPT (n = 144), IS (n = 56), and Swimming (n = 13). Dual-energy X-ray absorptiometry was used to determine body composition (percentage of fat, fat mass, and fat-free mass) and bone mass (BMD, BMD Z-Score, total BMC, arm BMC, leg BMC, and trunk BMC), at the beginning of the military service and after 7 months of training.
RESULTS


It was observed a significant increase in BMD, BMD Z-Score, total BMC and BMC of all segments analyzed for all groups (p < 0.01). There was a significantly greater variation in BMD of the IS group in relation to the MPT group (p < 0.01), and in the arm BMC of the MPT group in relation to the IS group (p < 0.05).
CONCLUSION


After 7 months of training, there were significant increases in BMC and BMD of all the groups evaluated. The bone response was associated with the muscular group used in the physical exercise and the IS group showed greater gain in BMD.",2019,"It was observed a significant increase in BMD, BMD Z-Score, total BMC and BMC of all segments analyzed for all groups (p < 0.01).","['Young Adults', '213 military school students (male and aged 19.2 ± 1.2 years) divided into three groups: MPT (n = 144), IS (n = 56), and Swimming (n = 13', 'young military adults']","['Dual-energy X-ray absorptiometry', 'Physical activity (PA', 'Physical Training and Military Routine', 'military physical training (MPT), impact sports (IS), and swimming']","['gain in BMD', 'body composition (percentage of fat, fat mass, and fat-free mass) and bone mass (BMD, BMD Z-Score, total BMC, arm BMC, leg BMC, and trunk BMC', 'BMD', 'bone response', 'BMD, BMD Z-Score, total BMC and BMC', 'BMC and BMD', 'bone mineral density (BMD) and bone mineral content (BMC']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}]",213.0,0.0266679,"It was observed a significant increase in BMD, BMD Z-Score, total BMC and BMC of all segments analyzed for all groups (p < 0.01).","[{'ForeName': 'Josiel Almeida', 'Initials': 'JA', 'LastName': 'de Avila', 'Affiliation': 'Growth and Body Composition Lab, Center for Investigation in Pediatrics, Faculty of Medical Sciences, University of Campinas (UNICAMP), 126 Tessália Vieira de Camargo Rue, Cidade Universitária Zeferino Vaz, 13083-887 - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Mauro Augusto Schreiter', 'Initials': 'MAS', 'LastName': 'Melloni', 'Affiliation': 'Growth and Body Composition Lab, Center for Investigation in Pediatrics, Faculty of Medical Sciences, University of Campinas (UNICAMP), 126 Tessália Vieira de Camargo Rue, Cidade Universitária Zeferino Vaz, 13083-887 - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Mauro Alexandre', 'Initials': 'MA', 'LastName': 'Pascoa', 'Affiliation': 'Growth and Body Composition Lab, Center for Investigation in Pediatrics, Faculty of Medical Sciences, University of Campinas (UNICAMP), 126 Tessália Vieira de Camargo Rue, Cidade Universitária Zeferino Vaz, 13083-887 - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Vagner Xavier', 'Initials': 'VX', 'LastName': 'Cirolini', 'Affiliation': 'Growth and Body Composition Lab, Center for Investigation in Pediatrics, Faculty of Medical Sciences, University of Campinas (UNICAMP), 126 Tessália Vieira de Camargo Rue, Cidade Universitária Zeferino Vaz, 13083-887 - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Camila Justino de Oliveira', 'Initials': 'CJO', 'LastName': 'Barbeta', 'Affiliation': 'Growth and Body Composition Lab, Center for Investigation in Pediatrics, Faculty of Medical Sciences, University of Campinas (UNICAMP), 126 Tessália Vieira de Camargo Rue, Cidade Universitária Zeferino Vaz, 13083-887 - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Rafael Almeida', 'Initials': 'RA', 'LastName': 'de Avila', 'Affiliation': 'Faculty of Medical Sciences, Federal University of Santa Maria (UFSM), 1000 Roraima Avenue, Cidade Universitária, Camobi, 97105-900 - Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Ezequiel Moreira', 'Initials': 'EM', 'LastName': 'Gonçalves', 'Affiliation': 'Growth and Body Composition Lab, Center for Investigation in Pediatrics, Faculty of Medical Sciences, University of Campinas (UNICAMP), 126 Tessália Vieira de Camargo Rue, Cidade Universitária Zeferino Vaz, 13083-887 - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Guerra-Junior', 'Affiliation': 'Growth and Body Composition Lab, Center for Investigation in Pediatrics, Faculty of Medical Sciences, University of Campinas (UNICAMP), 126 Tessália Vieira de Camargo Rue, Cidade Universitária Zeferino Vaz, 13083-887 - Campinas, São Paulo, Brazil.'}]",Military medicine,['10.1093/milmed/usz001']
703,31289053,Formative mixed-method multicase study research to inform the development of a safer sex and healthy relationships intervention in further education (FE) settings: the SaFE Project.,"OBJECTIVES


Sexual health includes pleasurable, safe, sexual experiences free from coercion, discrimination and violence. In the UK, many young people's experiences fall short of this definition. This study aimed to inform the development of a safer sex and healthy relationships intervention for those aged 16-19 years studying in further education (FE) settings.
DESIGN


A formative mixed-method multicase study explored if and how to implement four components within a single intervention.
SETTING


Six FE settings in England and Wales and one sexual health charity participated between October and July 2015.
PARTICIPANTS


Focus groups with 134 FE students and 44 FE staff, and interviews with 11 FE managers and 12 sexual health charity staff, first explored whether four candidate intervention components were acceptable and could have sustained implementation. An e-survey with 2105 students and 163 staff then examined potential uptake and acceptability of components shortlisted in the first stage. Stakeholder consultation was then used to refine the intervention.
INTERVENTION


Informed by a review of evidence of effective interventions delivered in other settings, four candidate intervention components were identified which could promote safer sex and healthy relationships among those aged 16-19 years: 1) student-led sexual health action groups; 2) on-site sexual health and relationships services; 3) staff safeguarding training about sexual health and relationships and 4) sex and relationships education.
RESULTS


On-site sexual health and relationships services and staff safeguarding training about sexual health and relationships were key gaps in current FE provision and welcomed by staff, students and health professionals. Sex and relationships education and student-led sexual health action groups were not considered acceptable.
CONCLUSIONS


The SaFE intervention, comprising on-site sexual health and relationships services and staff safeguarding training in FE settings, may have potential promoting sexual health among FE students. Further optimisation and refinement with key stakeholders is required before piloting via cluster randomised controlled trial.",2019,"RESULTS


On-site sexual health and relationships services and staff safeguarding training about sexual health and relationships were key gaps in current FE provision and welcomed by staff, students and health professionals.","['those aged 16-19\u2009years studying in further education (FE) settings', 'Six FE settings in England and Wales and one sexual health charity participated between October and July 2015', 'Focus groups with 134 FE students and 44 FE staff, and interviews with 11 FE managers and 12 sexual health charity staff', 'those aged 16-19\u2009years: 1) student-led sexual health action groups']",[],['site sexual health and relationships services'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0578818', 'cui_str': 'In further education (finding)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]",,0.031228,"RESULTS


On-site sexual health and relationships services and staff safeguarding training about sexual health and relationships were key gaps in current FE provision and welcomed by staff, students and health professionals.","[{'ForeName': 'Honor', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Turney', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), Cardiff University, Cardiff, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), Cardiff University, Cardiff, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Health and Wellbeing, MRC Social and Public Health Sciences Unit, Glasgow, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Public Health and Policy, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-024692']
704,31398375,"Predictors of recurrence, early treatment failure and death from Staphylococcus aureus bacteraemia: Observational analyses within the ARREST trial.","OBJECTIVES


Adjunctive rifampicin did not reduce failure/recurrence/death as a composite endpoint in the ARREST trial of Staphylococcus aureus bacteraemia, but did reduce recurrences. We investigated clinically-defined 14-day treatment failure, and recurrence and S. aureus-attributed/unattributed mortality by 12-weeks to further define their predictors.
METHODS


A post-hoc exploratory analysis using competing risks models was conducted to identify sub-groups which might benefit from rifampicin. A points-based recurrence risk score was developed and used to compare rifampicin's benefits.
RESULTS


Recurrence was strongly associated with liver and renal failure, diabetes and immune-suppressive drugs (p < 0.005); in contrast, failure and S. aureus-attributed mortality were associated with older age and higher neutrophil counts. Higher SOFA scores predicted mortality; higher Charlson scores and deep-seated initial infection focus predicted failure. Unexpectedly, recurrence risk increased with increasing BMI in placebo (p = 0.04) but not rifampicin (p = 0.60) participants (p heterogeneity  = 0.06). A persistent focus was judged the primary reason for recurrence in 23(74%). A 5-factor risk score based on BMI, Immunosuppression, Renal disease, Diabetes, Liver disease (BIRDL) strongly predicted recurrence (p < 0.001).
CONCLUSIONS


Rifampicin reduces recurrences overall; those with greatest absolute risk reductions were identified using a simple risk score. Source control and adequate duration of antibiotic therapy remain essential to prevent recurrence and improve outcomes.",2019,"Unexpectedly, recurrence risk increased with increasing BMI in placebo (p = 0.04) but not rifampicin (p = 0.60) participants (p heterogeneity  = 0.06).",[],"['rifampicin', 'Rifampicin', 'placebo']","['failure/recurrence/death', 'liver and renal failure, diabetes and immune-suppressive drugs', 'recurrence risk', '5-factor risk score based on BMI, Immunosuppression, Renal disease, Diabetes, Liver disease (BIRDL) strongly predicted recurrence']",[],"[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}]",,0.175106,"Unexpectedly, recurrence risk increased with increasing BMI in placebo (p = 0.04) but not rifampicin (p = 0.60) participants (p heterogeneity  = 0.06).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Szubert', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, UK.'}, {'ForeName': 'Sarah Lou', 'Initials': 'SL', 'LastName': 'Bailey', 'Affiliation': ""Guy's and St. Thomas' NHS Foundation Trust, London, UK; Kings College London, London, UK.""}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Cooke', 'Affiliation': 'Imperial College London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Llewelyn', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Edgeworth', 'Affiliation': ""Guy's and St. Thomas' NHS Foundation Trust, London, UK; Kings College London, London, UK.""}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, University College London, UK; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, UK; Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam. Electronic address: gthwaites@oucru.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infection,['10.1016/j.jinf.2019.08.001']
705,31388518,Neuro-autonomic changes induced by remote ischemic preconditioning (RIPC) in healthy young adults: Implications for stress.,"The mechanisms underlying the protective effects of remote ischemic preconditioning (RIPC) are not presently clear. Recent studies in experimental models suggest the involvement of the autonomic nervous system (ANS) in cardioprotection. The aim of this study was to investigate the changes in ANS in healthy young volunteers divided into RIPC (n = 22) or SHAM (n = 18) groups. RIPC was induced by 1 cycle of 4 min inflation/5 min deflation followed by 2 cycles of 5 min inflation/5 min deflation of a cuff placed on the upper left limb. The study included analysis of heart rate (HR), blood pressure (BP), heart rate variability (HRV), measurements of microcirculation and porphyrin fluorescence in the limb before and after the RIPC. RIPC caused reactive hyperemia in the limb and reduced blood porphyrin level. A mental load (serial sevens test) and mild motor stress (hyperventilation) were performed on all subjects before and after RIPC or corresponding rest in the SHAM group. Reduction of HR occurred during the experiments in both RIPC and SHAM groups reflecting RIPC-independent adaptation of the subjects to the experimental procedure. However, in contrast to the SHAM group, RIPC altered several of the spectral indices of HRV during the serial sevens test and hyperventilation. This was expressed predominantly as an increase in power of the very low-frequency band of the spectrum, increased values of detrended fluctuation analysis and weakening of correlation between the HRV parameters and HR. In conclusion, RIPC induces changes in the activity of ANS that are linked to stress resistance.",2019,Reduction of HR occurred during the experiments in both RIPC and SHAM groups reflecting RIPC-independent adaptation of the subjects to the experimental procedure.,"['healthy young adults', 'healthy young volunteers divided into RIPC (n\u202f=\u202f22) or']","['remote ischemic preconditioning (RIPC', 'RIPC and SHAM', 'SHAM', 'RIPC']","['blood porphyrin level', 'heart rate (HR), blood pressure (BP), heart rate variability (HRV), measurements of microcirculation and porphyrin fluorescence', 'reactive hyperemia', 'mild motor stress (hyperventilation', 'Reduction of HR']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1278129', 'cui_str': 'Blood porphyrin measurement'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0032712', 'cui_str': 'Porphyrins'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.047496,Reduction of HR occurred during the experiments in both RIPC and SHAM groups reflecting RIPC-independent adaptation of the subjects to the experimental procedure.,"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Khaliulin', 'Affiliation': 'Bristol Medical School, University of Bristol, Level 7, Bristol Royal Infirmary, Upper Maudlin Street, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Arnold N', 'Initials': 'AN', 'LastName': 'Fleishman', 'Affiliation': 'Research Institute for Complex Problems of Hygiene and Occupational Diseases, 23 Ulitsa Kutuzova, Novokuznetsk, Kemerovo Oblast, 654041, Russia.'}, {'ForeName': 'Nadezhda I', 'Initials': 'NI', 'LastName': 'Shumeiko', 'Affiliation': 'Research Institute for Complex Problems of Hygiene and Occupational Diseases, 23 Ulitsa Kutuzova, Novokuznetsk, Kemerovo Oblast, 654041, Russia.'}, {'ForeName': 'TatyanaV', 'Initials': 'T', 'LastName': 'Korablina', 'Affiliation': 'Information Technology Department, Siberian State Industrial University, Ulitsa Kirova, 42, Novokuznetsk, Kemerovo Oblast, 654007, Russia.'}, {'ForeName': 'Stanislav A', 'Initials': 'SA', 'LastName': 'Petrovskiy', 'Affiliation': 'Research Institute for Complex Problems of Hygiene and Occupational Diseases, 23 Ulitsa Kutuzova, Novokuznetsk, Kemerovo Oblast, 654041, Russia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Ascione', 'Affiliation': 'Bristol Medical School, University of Bristol, Level 7, Bristol Royal Infirmary, Upper Maudlin Street, Bristol, BS2 8HW, UK.'}, {'ForeName': 'M-Saadeh', 'Initials': 'MS', 'LastName': 'Suleiman', 'Affiliation': 'Bristol Medical School, University of Bristol, Level 7, Bristol Royal Infirmary, Upper Maudlin Street, Bristol, BS2 8HW, UK.'}]",Neurobiology of stress,['10.1016/j.ynstr.2019.100189']
706,31213445,"Individualised screening for diabetic retinopathy: the ISDR study-rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening.","INTRODUCTION


Currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.
METHODS AND ANALYSIS


PWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.
ETHICS AND DISSEMINATION


Ethical approval was obtained from National Research Ethics Service Committee North West - Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.
TRIAL REGISTRATION NUMBER


ISRCTN87561257; Pre-results.",2019,"Currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually.","['PWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme', 'diabetic retinopathy', 'people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually']","['RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals', 'Individualised screening', 'personalised variable-interval risk-based screening for DR']","['safety, acceptability and cost-effectiveness', 'attendance rates', 'rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life', 'attendance for follow-up screening']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",,0.406542,"Currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually.","[{'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Broadbent', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sampson', 'Affiliation': 'Division of Rehabilitation and Ageing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Amu', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Abigail E', 'Initials': 'AE', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Susan U', 'Initials': 'SU', 'LastName': 'Howlin', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Appelbe', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Moitt', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cheyne', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mehrdad Mobayen', 'Initials': 'MM', 'LastName': 'Rahni', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Patient and Public Involvement Group, Liverpool, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': 'Patient and Public Involvement Group, Liverpool, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Stratton', 'Affiliation': 'Gloucestershire Retinal Research Group, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'Division of Rehabilitation and Ageing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025788']
707,31915308,"Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility).","New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).",2020,"There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained.","['adults with a modified medical research council breathlessness scale score ≥3', 'severe breathlessness in advanced lung disease']","['placebo', 'mirtazapine', 'EudraCT']","['tolerability or safety, and blinding', 'Worst breathlessness ratings']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3472510', 'cui_str': 'Medical Research Council breathlessness scale score'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0429691', 'cui_str': 'Breathlessness rating (staging scale)'}]",64.0,0.7013,"There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained.","[{'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK irene.higginson@kcl.ac.uk.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilcock', 'Affiliation': 'Department of Clinical Oncology, University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, The University of Hull, Hull, UK.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Bajwah', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lovell', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Hart', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, University of Hull, Castle Hill Hospital, University of Hull, Hull, Kingston upon Hull, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Crosby', 'Affiliation': 'Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Poad', 'Affiliation': 'Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Currow', 'Affiliation': 'Faculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Best', 'Affiliation': 'Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213879']
708,30427588,Effect of Food on the Pharmacokinetics of Ertugliflozin and Its Fixed-Dose Combinations Ertugliflozin/Sitagliptin and Ertugliflozin/Metformin.,"Ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, is approved in the United States and European Union for the treatment of type 2 diabetes in adults, both as monotherapy and as part of fixed-dose combination (FDC) therapies with either sitagliptin or immediate-release metformin. The effect of a standard, high-fat breakfast on the pharmacokinetics of the highest strengths of ertugliflozin monotherapy (15 mg), ertugliflozin/sitagliptin FDC (15-/100-mg), and ertugliflozin/metformin FDC (7.5-/1000-mg) tablets was evaluated. In 3 separate open-label, 2-period, 2-sequence, single-dose, crossover studies, 14 healthy subjects per study were randomized to receive either ertugliflozin monotherapy or FDC tablets comprising ertugliflozin and sitagliptin or ertugliflozin and metformin under fasted and fed (or vice versa) conditions. Food did not meaningfully affect the pharmacokinetics of ertugliflozin, sitagliptin, or metformin. For FDCs, the effect of food was consistent with that described for individual components. All treatments were well tolerated. Ertugliflozin and ertugliflozin/sitagliptin FDC tablets can be administered without regard to meals. As metformin is administered with meals because of its gastrointestinal side effects, the ertugliflozin/metformin FDC should also be administered with meals.",2019,"Food did not meaningfully affect the pharmacokinetics of ertugliflozin, sitagliptin, or metformin.",['14 healthy subjects per study'],"['Ertugliflozin', 'metformin', 'ertugliflozin monotherapy', 'ertugliflozin monotherapy or FDC tablets comprising ertugliflozin and sitagliptin or ertugliflozin and metformin under fasted and fed (or vice versa) conditions', 'ertugliflozin/sitagliptin FDC (15-/100-mg), and ertugliflozin/metformin FDC (7.5-/1000-mg) tablets', 'Ertugliflozin and Its Fixed-Dose Combinations Ertugliflozin/Sitagliptin and Ertugliflozin/Metformin', 'ertugliflozin/metformin FDC', 'Ertugliflozin and ertugliflozin/sitagliptin FDC tablets']","['pharmacokinetics of ertugliflozin, sitagliptin, or metformin', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4535697', 'cui_str': 'ertugliflozin / sitagliptin'}, {'cui': 'C4535599', 'cui_str': 'ertugliflozin / Metformin'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]",14.0,0.0207993,"Food did not meaningfully affect the pharmacokinetics of ertugliflozin, sitagliptin, or metformin.","[{'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Fediuk', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Matschke', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Almasa', 'Initials': 'A', 'LastName': 'Bass', 'Affiliation': 'Pfizer Inc., Durham, NC, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Vikas K', 'Initials': 'VK', 'LastName': 'Dawra', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.629']
709,32100576,"The Efficacy and Safety of Acupuncture for Preventing Radiation Pneumonitis in Patients With Lung Cancer: A Prospective, Single-Blinded, Randomized Pilot Proof-of-Principle Study.","Purpose:  We evaluated the efficacy and safety of acupuncture for prevention of radiation pneumonitis in patients with lung cancer.  Methods:  Twenty-five patients were prospectively enrolled in this study and randomized to either intervention group or control group. The patients assigned to the intervention group received 15 minutes of acupuncture treatment twice a week. The patients assigned to the control group received RT alone without acupuncture treatment. The primary endpoint was incidence of radiation pneumonitis. The secondary endpoints were FEV1 (forced expiratory volume in 1 second), DLCO (diffusing capacity for carbon monoxide), 6-minute walk distance, and modified Borg scale.  Results:  The intervention group showed lower incidences of grade 3 and grade ≥2 radiation pneumonitis than the control group (10% vs 30% for grade 3 and 50% vs 60% for grade ≥2). In the control group, mean DLCO value was decreased from 62.1% at baseline to 49.1% after RT ( P  = .004). The DLCO was also decreased after RT in the intervention group, but the decrement was not statistically significant (56.7% at baseline and 50.9% after RT,  P  = .204). The FEV1 and 6-minute walk distance were decreased after RT in the control group. However, FEV1 and 6-minute walk distance were increased after RT in the intervention group.  Conclusions:  This study found that patients who received acupuncture treatment showed a lower incidence of radiation pneumonitis and a protective effect against aggravation of pulmonary function after RT in patients with lung cancer. To confirm the results of this study, well-designed randomized studies with large sample sizes will be required.",2020,The intervention group showed lower incidences of grade 3 and grade ≥2 radiation pneumonitis than the control group (10% vs 30% for grade 3 and 50% vs 60% for grade ≥2).,"['patients with lung cancer', 'Methods:  Twenty-five patients', 'Patients With Lung Cancer']","['acupuncture', 'Acupuncture', 'RT alone without acupuncture treatment', 'intervention group or control group']","['incidence of radiation pneumonitis', 'lower incidences of grade 3 and grade ≥2 radiation pneumonitis', 'efficacy and safety', 'FEV1 and 6-minute walk distance', 'DLCO', 'FEV1 (forced expiratory volume in 1 second), DLCO (diffusing capacity for carbon monoxide), 6-minute walk distance, and modified Borg scale', 'radiation pneumonitis', 'mean DLCO value', 'Radiation Pneumonitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1280474', 'cui_str': 'Transfer factor (respiratory measure) (observable entity)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",25.0,0.0423814,The intervention group showed lower incidences of grade 3 and grade ≥2 radiation pneumonitis than the control group (10% vs 30% for grade 3 and 50% vs 60% for grade ≥2).,"[{'ForeName': 'Moonkyoo', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Hyeun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jaehyo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Beom-Joon', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Kwan-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Integrative cancer therapies,['10.1177/1534735420908327']
710,32109255,"A randomized controlled study incorporating an electromechanical gait machine, the Hybrid Assistive Limb, in gait training of patients with severe limitations in walking in the subacute phase after stroke.","Early onset, intensive and repetitive, gait training may improve outcome after stroke but for patients with severe limitations in walking, rehabilitation is a challenge. The Hybrid Assistive Limb (HAL) is a gait machine that captures voluntary actions and support gait motions. Previous studies of HAL indicate beneficial effects on walking, but these results need to be confirmed in blinded, randomized controlled studies. This study aimed to explore effects of incorporating gait training with HAL as part of an inpatient rehabilitation program after stroke. Thirty-two subacute stroke patients with severe limitations in walking were randomized to incorporated HAL training (4 days/week for 4 weeks) or conventional gait training only. Blinded assessments were carried out at baseline, after the intervention, and at 6 months post stroke. The primary outcome was walking independence according to the Functional Ambulation Categories. Secondary outcomes were the Fugl-Meyer Assessment, 2-Minute Walk Test, Berg Balance Scale, and the Barthel Index. No significant between-group differences were found regarding any primary or secondary outcomes. At 6 months, two thirds of all patients were independent in walking. Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048). This study found no difference between groups for any outcomes despite the extra resources required for the HAL training, but highlights the substantial improvements in walking seen when evidence-based rehabilitation is provided to patients, with severe limitations in walking in the subacute stage after stroke. In future studies potential subgroups of patients who will benefit the most from electromechanically-assisted gait training should be explored.",2020,"Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048).","['Thirty-two subacute stroke patients with severe limitations in walking', 'patients with severe limitations in walking in the subacute phase after stroke']","['HAL', 'electromechanical gait machine, the Hybrid Assistive Limb, in gait training', 'conventional gait training only', 'Hybrid Assistive Limb (HAL', 'HAL training', 'gait training with HAL']","['Fugl-Meyer Assessment, 2-Minute Walk Test, Berg Balance Scale, and the Barthel Index', 'walking independence according to the Functional Ambulation Categories']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}]",32.0,0.0927106,"Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048).","[{'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Wall', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Borg', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Vreede', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Palmcrantz', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0229707']
711,31259767,HIV stigma and viral load among African-American women receiving treatment for HIV.,"OBJECTIVE


African-American women are more likely than other women in the United States to experience poor HIV-related health; HIV stigma may contribute to these outcomes. This study assessed the relationship between HIV stigma and viral load, over time, among a sample of African-American women receiving treatment for HIV, and explored social support and depressive symptoms as mediators.
DESIGN


Secondary analysis of longitudinal data.
METHODS


Data came from a randomized trial of an intervention to reduce HIV stigma among African-American women in HIV care in Chicago, Illinois and Birmingham, Alabama. Sociodemographic and psychosocial data were collected at up to six study visits over 14 months. Viral loads were extracted from medical records during the study period. Generalized linear mixed effects models were used to estimate associations among overall, internalized, and enacted HIV stigma and viral load over time. Mediation analyses were used to estimate indirect effects via social support and depressive symptoms.
RESULTS


Data from 234 women were analyzed. Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005). Both between-subject (adjusted β = 0.74, P < 0.001) and within-subject (adjusted β = 0.34, P = 0.005) differences in enacted stigma were associated with viral load. Neither social support nor depressive symptoms were statistically significant mediators.
CONCLUSION


Ongoing experiences of HIV stigmatization may contribute to increased viral load among African-American women in primary HIV care. Interventions should aim to alleviate the consequences of stigma experienced by patients and prevent future stigmatization.",2019,"Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005).","['African-American women in HIV care in Chicago, Illinois and Birmingham, Alabama', 'African-American women', 'African-American women in primary HIV care', '234 women were analyzed', 'African-American women receiving treatment for HIV', 'African-American women receiving treatment for HIV, and explored social support and depressive symptoms as mediators']",[],"['Overall HIV stigma', 'enacted stigma', 'Sociodemographic and psychosocial data', 'depressive symptoms', 'HIV stigma', 'overall, internalized, and enacted HIV stigma and viral load over time', 'Viral loads', 'HIV stigma and viral load']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037438'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",234.0,0.0469557,"Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005).","[{'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Kemp', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lipira', 'Affiliation': 'Department of Health Services.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'School of Social Work.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Nevin', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Simoni', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohn', 'Affiliation': 'Division of Infectious Diseases, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Mieoak', 'Initials': 'M', 'LastName': 'Bahk', 'Affiliation': 'Ruth M. Rothstein CORE Center, Chicago, Illinois.'}, {'ForeName': 'Baiba', 'Initials': 'B', 'LastName': 'Berzins', 'Affiliation': 'Division of Infectious Diseases, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Andrasik', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Global Health.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002212']
712,31269926,"A physical activity, nutrition and oral health intervention in nursery settings: process evaluation of the NAP SACC UK feasibility cluster RCT.","BACKGROUND


The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. A feasibility randomised controlled trial was conducted in England to adapt the intervention to the UK context. An embedded process evaluation focused on three key questions. 1. Was it feasible and acceptable to implement the intervention as planned? 2. How did the intervention affect staff and parent mediators? 3. Were the trial design and methods acceptable?
METHODS


Twelve nurseries in south-west England were recruited and randomised to intervention or control. The intervention comprised: NAP SACC UK Partner (Health Visitor) support to nurseries to review practice and policies against best practice, and then set goals to improve physical activity, nutrition and oral health; two staff training workshops; and a web-based parent support element. The process evaluation comprised: observations of Partner training (n = 1), Partner/manager meetings (n = 5) and staff workshops (n = 10); semi-structured interviews with Partners (n = 4), managers (n = 12), staff (n = 4) and parents (n = 20); analysis of self-assessment forms, goal setting forms and Partner logbooks; and assessment of staff and parent knowledge, motivation and self-efficacy mediators.
RESULTS


Overall, NAP SACC UK was feasible to implement and acceptable to nursery staff, managers, Partners and parents. The intervention was implemented as planned in five of the six intervention nurseries. Partners and managers appreciated the opportunity to review and improve nursery practices and valued the relationship forged between them. Staff rated the training workshops highly, despite attending outside of working hours. Most goals set by nurseries were achieved. However, Partners raised concerns about Health Visitors' capacity to deliver the intervention in any subsequent roll out. Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group. The web-based parent element was not well used and should be removed from any subsequent trial. The trial methods were acceptable to managers, staff, Partners and parents.
CONCLUSIONS


Implementing and evaluating a physical activity and nutrition intervention in nursery settings is feasible and acceptable. A full RCT of NAP SACC UK (with appropriate modifications) is warranted.
TRIAL REGISTRATION


ISRCTN16287377 (10 Apr 2015).",2019,"Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group.","['Twelve nurseries in south-west England', 'nursery settings']","['childcare (NAP SACC) intervention', 'Partner training (n\u2009=\u20091), Partner/manager meetings (n\u2009=\u20095) and staff workshops (n\u2009=\u200910); semi-structured interviews with Partners', 'NAP SACC UK Partner (Health Visitor']",['Mediator scores'],"[{'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",3.0,0.0637596,"Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Langford', 'Affiliation': 'DECIPHer, Bristol Medical School, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK. Beki.langford@bristol.ac.uk.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Jago', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Social Science Complex, 8 Priory Rd, Bristol, BS8 1TZ, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Centre for Trials Research, DECIPHer, College of Biomedical and Life Sciences, Cardiff University, 4th Floor Health Park, Cardiff, CF14 4YS, UK.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'Institute of Health & Wellbeing, MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow, G2 3AX, UK.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Papadaki', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Social Science Complex, 8 Priory Rd, Bristol, BS8 1TZ, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Rd, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Rd, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, Centre for Health promotion and Disease Prevention, University of North Carolina, 1700 M.L.K. Jr Blvd #7426, Chapel Hill, NC, 27514, USA.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'DECIPHer, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Rd, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Wells', 'Affiliation': 'DECIPHer, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Rd, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kipping', 'Affiliation': 'DECIPHer, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Rd, Bristol, BS8 2PS, UK.'}]",BMC public health,['10.1186/s12889-019-7102-9']
713,31126299,Changes in FTO and IRX3 gene expression in obese and overweight male adolescents undergoing an intensive lifestyle intervention and the role of FTO genotype in this interaction.,"BACKGROUND


Lifestyle intervention may have a critical effect on the association between genetics and obesity. This study aimed to investigate changes in FTO and IRX3 gene expression in obese and overweight male adolescents undergoing a lifestyle intervention and the role of FTO genotype in this interaction.
METHODS


This study was a field trial of 62 adolescents from boys' high schools in Tehran, Iran. Two schools were randomly allocated as the intervention (n = 30) and control (n = 32) schools. The rs9930506 SNP in FTO was genotyped at baseline and the level of FTO and IRX3 expression in peripheral blood mononuclear cells (PBMCs). Anthropometric measurements were assessed at baseline and after 18 weeks of intensive lifestyle intervention.
RESULTS


Our results showed that IRX3 expression in the intervention group was significantly up-regulated compared to baseline (P = 0.007) and compared to the control group (P = 0.011).The intervention group had significantly up-regulated transcripts of IRX3 only in rs9930506 risk allele carriers of the intervention group compared to risk allele carriers of the control group (P = 0.017). Moreover, our data showed that the FTO expression was up-regulated in AA genotype carriers and down-regulated in AG/GG genotype carriers (P = 0.017).
CONCLUSION


Lifestyle modification may exert its effects on obesity through changes in the expression level of the FTO and IRX3 genes. However, FTO genotype plays a role in the extent of the effect of lifestyle changes on gene expression. Further studies are crucial to have a better understanding of the interaction between lifestyle, genetics and anthropometric measurements. Trial registration This paper reports a comprehensive intervention study (Interactions of Genetics, Lifestyle and Anthropometrics study or IGLA study), which is retrospectively registered in the Iranian Registry of Clinical Trials as IRCT2016020925699N2. Date registered: April 24, 2016. ( https://www.irct.ir/searchresult.php?id=25699&number=2 ).",2019,Lifestyle modification may exert its effects on obesity through changes in the expression level of the FTO and IRX3 genes.,"['obese and overweight male adolescents undergoing a', 'obese and overweight male adolescents undergoing an', ""62 adolescents from boys' high schools in Tehran, Iran""]","['lifestyle intervention', 'intensive lifestyle intervention']","['FTO expression', 'level of FTO and IRX3 expression in peripheral blood mononuclear cells (PBMCs', 'FTO and IRX3 gene expression', 'IRX3 expression', 'Anthropometric measurements']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",62.0,0.0291192,Lifestyle modification may exert its effects on obesity through changes in the expression level of the FTO and IRX3 genes.,"[{'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Doaei', 'Affiliation': 'Research Center of Health and Environment, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Kalantari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pantea', 'Initials': 'P', 'LastName': 'Izadi', 'Affiliation': 'Department of Medical Genetics, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tuire', 'Initials': 'T', 'LastName': 'Salonurmi', 'Affiliation': 'Department of Internal Medicine, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mosavi Jarrahi', 'Affiliation': 'Faculty of Medical School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Rafieifar', 'Affiliation': 'Health Promotion and Education Department, Ministry of Health, Tehran, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Azizi Tabesh', 'Affiliation': 'Department of Medical Genetics, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Rahimzadeh', 'Affiliation': 'Institute for Intelligent Systems Research and Innovation (IISRI), Deakin University, Geelong Waurn Ponds, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gholamalizadeh', 'Affiliation': 'Student Research Committee, Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Gholamalizadeh@sbmu.ac.ir.'}, {'ForeName': 'Mark O', 'Initials': 'MO', 'LastName': 'Goodarzi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",Journal of translational medicine,['10.1186/s12967-019-1921-4']
714,31676719,Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial.,"BACKGROUND


People with recurrent or drug-resistant TB require long courses of intramuscular injections. We evaluate a novel system in which patient-nominated lay carers were trained to deliver intramuscular injections to patients in their own homes.
METHODS


A pragmatic, individually randomised non-inferiority trial was conducted at two hospitals in Malawi. Adults starting TB retreatment were recruited. Patients randomised to the intervention received home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin. Patients receiving standard care were admitted to hospital for 2 months of streptomycin. The primary outcome was successful treatment (alive and on treatment) at the end of the intervention.
RESULTS


Of 456 patients screened, 204 participants were randomised. The trial was terminated early due to futility. At the end of the intervention, 97/101 (96.0%) in the hospital arm were still alive and on treatment compared with 96/103 (93.2%) in the home-based arm (risk difference -0.03 (95% CI -0.09 to 0.03); p value 0.538). There were no differences in the proportion completing 8 months of anti-TB treatment; or the proportion experiencing 2-month sputum culture conversion. The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management. Home-based care reduced risk of catastrophic household costs by 84%.
CONCLUSIONS


Although this trial failed to meet target recruitment, the available data demonstrate that training patient-nominated lay people has potential to provide a feasible solution to the operational challenges associated with delivering long-term-injectable drugs to people with recurrent or drug-resistant TB in resource-limited settings, and substantially reduce costs. Further data under operational conditions are required.
TRIAL REGISTRATION NUMBER


ISRCTN05815615.",2020,"The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management.","['TB by lay carers', 'People with recurrent or drug-resistant TB require long courses of intramuscular injections', 'Patients receiving standard care were admitted to hospital for 2\u2009months of streptomycin', '456 patients screened, 204 participants were randomised', 'patient-nominated lay carers', 'two hospitals in Malawi', 'Adults starting TB retreatment were recruited']",['home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin'],"['successful treatment (alive and on treatment', 'mean cost of hospital-based management']","[{'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",204.0,0.212781,"The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management.","[{'ForeName': 'Danielle B', 'Initials': 'DB', 'LastName': 'Cohen', 'Affiliation': 'Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK Danielle.Cohen@sheffield.ac.uk.'}, {'ForeName': 'Kuzani', 'Initials': 'K', 'LastName': 'Mbendera', 'Affiliation': 'Malawi National TB Programme, Lilongwe, Malawi.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mangochi', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Phiri', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Division of Health Sciences, University of Warwick, Warwick, UK.'}, {'ForeName': 'Geraint', 'Initials': 'G', 'LastName': 'Davies', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Corbett', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Bertel', 'Initials': 'B', 'LastName': 'Squire', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",Thorax,['10.1136/thoraxjnl-2018-212675']
715,31891136,Posterior lamellar versus bilamellar tarsal rotation surgery for trachomatous trichiasis: Long-term outcomes from a randomised controlled trial.,"Background


We re-examined the participants of a clinical trial four years after enrolment to identify which of the two most commonly used eyelid surgery procedures to treat the blinding stage of trachoma (trachomatous trichiasis, TT), the posterior Lamellar Tarsal Rotation (PLTR) and Billamelar Tarsal Rotation (BLTR), gives better results in the long-term.
Methods


A randomised, controlled, single masked clinical trial was done in Ethiopia. At baseline, adults (aged >18 years with upper lid unoperated TT were recruited from a community-based screening. Participants were randomly assigned (1:1), to either BLTR or PLTR surgery, stratified by surgeon. At 4 years an independent assessor masked to allocation examined the trial participants' eyes using the same procedures as for the baseline and earlier follow-ups. The primary outcome was the proportion of individuals who had recurrence (postoperative TT, PTT) at the 4-year examination, or a history of repeat surgery in the 4-year period. The intervention effect was estimated by logistic regression, controlled for surgeon as a fixed effect in the model. The trial is registered with the Pan African Clinical Trials Registry (number PACTR201401000743135).
Findings


1000 participants with TT were enrolled, randomly assigned, and treated (501 in the BLTR group and 499 in the PLTR group) between Feb 13, 2014, and May 31, 2014. At year 4, 943 (94.3%) participants were re-examined (471, PLTR; 472, BLTR) and included in the primary outcome analysis. PTT had developed in 169/943 (17•9%) study eyes, among which 129 (76•3%) had minor trichiasis (≤5 lashes touching the eye). PTT was significantly more frequent at 4-year in the BLTR arm (105/472 [22•2%]) than the PLTR arm (64/471 [13•6%]), adjusted OR 1•82 (95% CI, 1•29-2•56);  p  = 0•0006, with 8•6% (95%CI 3•8-13•5) risk difference.
Interpretation


The PLTR surgical procedure had superior long-term outcomes to the BLTR with significantly lower risk of PTT supporting the current WHO guideline that the PLTR should be the procedure of choice for training new surgeons in the programmatic management of TT.",2019,"PTT was significantly more frequent at 4-year in the BLTR arm (105/472 [22•2%]) than the PLTR arm (64/471 [13•6%]), adjusted OR 1•82","['1000 participants with TT were enrolled, randomly assigned, and treated (501 in the BLTR group and 499 in the PLTR group) between Feb 13, 2014, and May 31, 2014', 'adults (aged >18 years with upper lid unoperated TT were recruited from a community-based screening']","['BLTR or PLTR surgery', 'Posterior lamellar versus bilamellar tarsal rotation surgery']","['proportion of individuals who had recurrence (postoperative TT, PTT) at the 4-year examination, or a history of repeat surgery', 'posterior Lamellar Tarsal Rotation (PLTR) and Billamelar Tarsal Rotation (BLTR', 'PTT']","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",1000.0,0.356988,"PTT was significantly more frequent at 4-year in the BLTR arm (105/472 [22•2%]) than the PLTR arm (64/471 [13•6%]), adjusted OR 1•82","[{'ForeName': 'Esmael', 'Initials': 'E', 'LastName': 'Habtamu', 'Affiliation': 'International Centre for Eye Health, Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Tariku', 'Initials': 'T', 'LastName': 'Wondie', 'Affiliation': 'The Carter Center, Addis Ababa, Ethiopia.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center, Addis Ababa, Ethiopia.'}, {'ForeName': 'Bezawit', 'Initials': 'B', 'LastName': 'Atinafu', 'Affiliation': 'The Carter Center, Addis Ababa, Ethiopia.'}, {'ForeName': 'Bizuayehu', 'Initials': 'B', 'LastName': 'Gashaw', 'Affiliation': 'Amhara Regional Health Bureau, Bahirdar, Ethiopia.'}, {'ForeName': 'Abebaw', 'Initials': 'A', 'LastName': 'Gebeyehu', 'Affiliation': 'Amhara Regional Health Bureau, Bahirdar, Ethiopia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kelly Callahan', 'Affiliation': 'The Carter Center, Atlanta, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.'}]",EClinicalMedicine,['10.1016/j.eclinm.2019.10.015']
716,32151214,A Randomized Controlled Trial of Video Psychoeducation for Electroconvulsive Therapy in the United States.,"OBJECTIVE


Electroconvulsive therapy (ECT) is a highly effective psychiatric treatment that remains largely underutilized. Patient psychoeducation about ECT may improve uptake of this treatment.
METHODS


This randomized controlled trial compared two forms of psychoeducation about ECT: video psychoeducation and an informational brochure. In 2019, a national sample of 556 U.S. adults who screened positive for depression were recruited and randomly assigned to receive one of these educational interventions online. Participant perceptions, knowledge, and willingness to receive ECT were assessed before and after psychoeducation.
RESULTS


Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups. The proportion of participants who reported being willing to receive ECT increased significantly after receipt of psychoeducation (from 31% to 63% in the video psychoeducation group and from 29% to 56% in the brochure group). Female gender, severity of depression, and comorbid mental and substance use disorders were associated with positive changes in ECT perceptions and increased willingness to receive ECT.
CONCLUSIONS


These findings suggest brief psychoeducation for ECT is needed and may improve acceptance of this robust treatment.",2020,"Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups.","['In 2019, a national sample of 556 U.S. adults who screened positive for depression']","['ECT', 'educational interventions online', 'Electroconvulsive therapy (ECT', 'psychoeducation about ECT: video psychoeducation and an informational brochure', 'Video Psychoeducation']","['positive perceptions and knowledge about ECT', 'Participant perceptions, knowledge, and willingness to receive ECT']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]",556.0,0.292575,"Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Minda', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rosenheck', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wilkinson', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900448']
717,32149388,The Effect of Renal Impairment on the Pharmacokinetics and Safety of Itacitinib.,"Itacitinib is a novel, selective, Janus kinase 1 inhibitor in development for treatment of graft-versus-host disease. The objective of this study was to assess pharmacokinetics and safety of 300-mg itacitinib dosed in participants with normal renal function (n = 10), severe renal impairment (n = 8), and end-stage renal disease (ESRD) on hemodialysis (n = 8). Serial plasma and urine samples (urine from normal and severe groups only) were collected before dosing until 72 hours after dosing. In the ESRD group, itacitinib was evaluated in 2 periods, when dosed before (period 1) and after (period 2) a hemodialysis session. Geometric mean ratios (90% confidence interval) in participants with severe renal impairment, ESRD period 1 and ESRD period 2 relative to participants with normal renal function were 1.65 (1.13-2.39), 0.71 (0.49-1.03), and 0.83 (0.57-1.20) for maximum plasma drug concentration and 2.23 (1.56-3.18), 0.81 (0.57-1.16), and 0.95 (0.66-1.35) for area under the plasma concentration-time curve from time zero to infinity. Itacitinib was well tolerated, and 3 grade 1 treatment-emergent adverse events were reported over the course of the study. Given the magnitude of exposure changes in participants with severe renal impairment or ESRD and the historic risk-benefit profile, no dose adjustment is recommended for itacitinib in patients with impaired renal function, although the final dosage recommendation will be based on cumulative pharmacokinetics and safety from this study and from the pivotal graft-versus-host disease trial. Additionally, itacitinib may be administered to patients undergoing dialysis regardless of the time of dialysis.",2020,"Geometric mean ratios (90% confidence interval) in participants with severe renal impairment, ESRD period 1 and ESRD period 2 relative to participants with normal renal function were 1.65 (1.13-2.39), 0.71 (0.49-1.03), and 0.83 (0.57-1.20) for maximum plasma drug concentration and 2.23 (1.56-3.18), 0.81 (0.57-1.16), and 0.95 (0.66-1.35) for area under the plasma concentration-time curve from time zero to infinity.","['patients with impaired renal function', 'participants with severe renal impairment or ESRD and the historic risk', 'participants with normal renal function (n = 10), severe renal impairment (n = 8), and end-stage renal disease (ESRD) on hemodialysis (n = 8']",['300-mg itacitinib'],"['pharmacokinetics and safety', 'maximum plasma drug concentration', 'Serial plasma and urine samples', 'Geometric mean ratios', 'normal renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}]",,0.0526038,"Geometric mean ratios (90% confidence interval) in participants with severe renal impairment, ESRD period 1 and ESRD period 2 relative to participants with normal renal function were 1.65 (1.13-2.39), 0.71 (0.49-1.03), and 0.83 (0.57-1.20) for maximum plasma drug concentration and 2.23 (1.56-3.18), 0.81 (0.57-1.16), and 0.95 (0.66-1.35) for area under the plasma concentration-time curve from time zero to infinity.","[{'ForeName': 'Nithya', 'Initials': 'N', 'LastName': 'Srinivas', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Barbour', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Epstein', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Gongfu', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Petusky', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Zhinyin', 'Initials': 'Z', 'LastName': 'Xun', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Yuska', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Marbury', 'Affiliation': 'Orlando Clinical Research Center, Orlando, Florida, USA.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Swamy', 'Initials': 'S', 'LastName': 'Yeleswaram', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Punwani', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1601']
718,31714954,Effect of Stopping Cotrimoxazole Preventive Therapy on Microbial Translocation and Inflammatory Markers Among Human Immunodeficiency Virus-Infected Ugandan Adults on Antiretroviral Therapy: The COSTOP Trial Immunology Substudy.,"BACKGROUND


Cotrimoxazole preventive therapy (CPT) in human immunodeficiency virus (HIV) infection is a World Health Organization-recommended standard of care in resource-limited settings, but the mechanism of CPT's beneficial effects is unclear. The COSTOP trial (ISRCTN44723643) evaluated the noninferiority of discontinuing CPT in stabilized patients on antiretroviral therapy. The COSTOP immunology substudy was conducted on a subset of COSTOP participants randomized to continue CPT (n = 86) or discontinue CPT (placebo, n = 86) as daily treatment for 1 year.
METHODS


We evaluated whether CPT reduces microbial translocation, indicated by the presence of bacterial lipopolysaccharide (LPS) and LPS control factors such as soluble CD14 (sCD14) and endotoxin core antibody (EndoCAb immunoglobulin M [IgM]) in plasma. Intestinal barrier damage as indicated by plasma intestinal fatty acid binding protein (IFABP), T-cell activation, and the inflammatory markers C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α) were also evaluated.
RESULTS


We found no significant change in markers of microbial translocation (LPS, IFABP, sCD14, and T-cell activation), with decreased EndoCAb IgM. There was significant increase in inflammation markers (CRP and IL-6) after stopping CPT compared to those who continued CPT.
CONCLUSIONS


These results add to the evidence of immunological benefits of CPT among HIV-infected populations in resource-limited settings. However, no evidence of reducing microbial translocation was observed.",2020,"There was significant increase in inflammation markers (CRP and IL-6) after stopping CPT compared to those who continued CPT.
","['stabilized patients on antiretroviral therapy', 'human immunodeficiency virus', 'Human Immunodeficiency Virus-Infected Ugandan Adults on Antiretroviral Therapy']","['discontinue CPT (placebo', 'Cotrimoxazole preventive therapy (CPT', 'Stopping Cotrimoxazole Preventive Therapy', 'CPT']","['Microbial Translocation and Inflammatory Markers', 'markers of microbial translocation (LPS, IFABP, sCD14, and T-cell activation', 'microbial translocation', 'inflammation markers (CRP and IL-6', 'plasma intestinal fatty acid binding protein (IFABP), T-cell activation, and the inflammatory markers C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α', 'EndoCAb IgM']","[{'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0163314', 'cui_str': 'Fatty Acid-Binding Proteins, Intestinal-Specific'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0020861', 'cui_str': 'IgM'}]",,0.1037,"There was significant increase in inflammation markers (CRP and IL-6) after stopping CPT compared to those who continued CPT.
","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kyosiimire-Lugemwa', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Zacchaeus', 'Initials': 'Z', 'LastName': 'Anywaine', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Abaasa', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gombe', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Musinguzi', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Grosskurth', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Munderi', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Pala', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz494']
719,32157608,A telephone-based education and support intervention for Rural Breast Cancer Survivors: a randomized controlled trial comparing two implementation strategies in rural Florida.,"PURPOSE


To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivors (RBCS) in which education was delivered early or after the support component.
METHODS


Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S) and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods.
RESULTS


Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, and 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (mean (standard deviation): SF-36 PCS, 44.88 (10.6) vs. 45.08 (10.6); MCS, 49.45 (11.1) vs. 48.1 (11.9); CES-D, 10.11 (9.8) vs. 10.86 (10.5); POMS-SF, 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS, 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen's d, - 0.22; 95% CI, - 0.38, - 0.06) and POMS (Cohen's d, 0.23; 95% CI, 0.07, 0.39) for EE-S vs. S-DE.
CONCLUSIONS


The implementation strategies were equivalent.
IMPLICATIONS FOR CANCER SURVIVORS


Enhancing support may be considered before delivering not-in-person interventions to RBCS.",2020,"There were no differences between EE-S and S-DE in demographics or outcomes at baseline (mean (standard deviation): SF-36 PCS, 44.88 (10.6) vs. 45.08","['rural Florida', 'Rural Breast Cancer Survivors', 'Rural Breast Cancer Survivors (RBCS', 'Of 432 RBCS (mean 25.6\xa0months from diagnosis', 'Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms']","['Early Education and Support (EE-S) and Support and Delayed Education (S-DE', 'telephone-based education and support intervention', 'implementation telephone-based strategies of an evidence-based educational and support intervention']","['depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study Social Support Survey, MOS-SSS', 'quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS', 'POMS']","[{'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0037438'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.207277,"There were no differences between EE-S and S-DE in demographics or outcomes at baseline (mean (standard deviation): SF-36 PCS, 44.88 (10.6) vs. 45.08","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Meneses', 'Affiliation': 'School of Nursing, Office of Research and Scholarship, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA. mpisu@uab.edu.""}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, Office of Research and Scholarship, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Benz', 'Affiliation': 'School of Nursing, Office of Research and Scholarship, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Mathematical Sciences, The University of Texas at El Paso, El Paso, TX, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McNees', 'Affiliation': 'School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00866-y']
720,32090730,High-dose oral vitamin D supplementation and mortality in people aged 65-84 years: the VIDAL cluster feasibility RCT of open versus double-blind individual randomisation.,"BACKGROUND


Randomised controlled trials demonstrating improved longevity are needed to justify high-dose vitamin D supplementation for older populations.
OBJECTIVES


To demonstrate the feasibility of a large trial ( n  ≈ 20,000) of high-dose vitamin D in people aged 65-84 years through general practitioner (GP) practices, and to cluster randomise participating practices between open-label and double-blind randomisation to compare effects on recruitment, compliance and contamination.
DESIGN


Twenty GP practices were randomised in matched pairs between open-label and double-blind allocation. Within each practice, patients were individually randomised to vitamin D or control (i.e. no treatment or placebo). Participants were invited to attend their GP practice to provide a blood sample and complete a lifestyle questionnaire at recruitment and again at 2 years. Randomisation by telephone followed receipt of a serum corrected calcium assay confirming eligibility (< 2.65 nmol/l). Treatment compliance was reported by quarterly follow-up forms sent and returned by e-mail or post (participant choice). GP visits and infections were abstracted from GP records. Hospital attendances, cancer diagnoses and deaths were ascertained by linkage to Hospital Episode Statistics and national registration through NHS Digital.
SETTING


GP practices in England.
PARTICIPANTS


Recruitment opened in October 2013 and closed in January 2015. A total of 1615 registered patients aged 65-84 years were randomised: 407 to vitamin D and 421 to no treatment in open practices; 395 to vitamin D and 392 to placebo in blind practices.
INTERVENTIONS


There was a 24-month treatment period: 12 monthly doses (100,000 IU of vitamin D 3  or placebo as 5 ml oily solution) were posted after randomisation and at 1 year (100,000 IU per month corresponds to 3300 IU per day). Reminders were sent monthly by e-mail, text message or post.
MAIN OUTCOME MEASURES


Recruitment, compliance, contamination and change in circulating 25-hydroxyvitamin D [25(OH)D] from baseline to 2 years.
RESULTS


Participation rates (randomised/invited) were 15.0% in open practices and 13.4% in double-blind practices ( p  = 0.7). The proportion still taking study medication at 2 years was 91.2% in open practices and 89.2% in double-blind practices ( p  = 0.4). The proportion of control participants taking > 400 IU vitamin D per day at 2 years was 5.0% in open practices and 4.8% in double-blind practices. Mean serum 25(OH)D concentration was 51.5 nmol/l [95% confidence interval (CI) 50.2 to 52.8 nmol/l] with 82.6% of participants < 75 nmol/l at baseline. At 2 years, this increased to 109.6 nmol/l (95% CI 107.1 to 112.1 nmol/l) with 12.0% < 75 nmol/l in those allocated to vitamin D and was unaltered at 51.8 nmol/l (95% CI 49.8 to 53.8 nmol/l) in those allocated to no vitamin D (no treatment or placebo).
CONCLUSIONS


A trial could recruit 20,000 participants aged 65-84 years through 200 GP practices over 2 years. Approximately 80% would be expected to adhere to allocated treatment (vitamin D or placebo) for 5 years. The trial could be conducted entirely by e-mail in participants aged < 80 years, but some participants aged 80-84 years would require postal follow-up. Recruitment and treatment compliance would be similar and contamination (self-administration of vitamin D) would be minimal, whether control participants are randomised openly to no treatment with no contact during the trial or randomised double-blind to placebo with monthly reminders.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN46328341 and EudraCT database 2011-003699-34.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 10. See the NIHR Journals Library website for further project information.",2020,Mean serum 25(OH)D concentration was 51.5 nmol/l,"['Participants were invited to attend their GP practice to provide a blood sample and complete a lifestyle questionnaire at recruitment and again at 2 years', '1615 registered patients aged 65-84 years', 'older populations', 'people aged 65-84 years through general practitioner (GP) practices, and to cluster randomise participating practices between', 'GP practices in England', 'people aged 65-84 years', 'participants aged <\u200980 years, but some participants aged 80-84 years would require postal follow-up', 'Twenty GP practices', 'Recruitment opened in October 2013 and closed in January 2015', '20,000 participants aged 65-84 years through 200 GP practices over 2 years', 'EudraCT database 2011-003699-34']","['High-dose oral vitamin D supplementation', 'vitamin D supplementation', 'vitamin D (no treatment or placebo', 'placebo', 'vitamin D 3  or placebo', 'vitamin D or placebo', 'high-dose vitamin D', 'open-label and double-blind randomisation', 'vitamin D or control (i.e. no treatment or placebo', 'vitamin D']","['Mean serum 25(OH)D concentration', 'GP visits and infections', 'Recruitment, compliance, contamination and change in circulating 25-hydroxyvitamin D [25(OH)D', 'Hospital attendances, cancer diagnoses and deaths']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1615.0,0.702849,Mean serum 25(OH)D concentration was 51.5 nmol/l,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rake', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Gilham', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Laurette', 'Initials': 'L', 'LastName': 'Bukasa', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ostler', 'Affiliation': 'Computational and Analytical Sciences, Rothamsted Research, Harpenden, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Newton', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peto Wild', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Aigret', 'Affiliation': 'Barts Clinical Trials Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Medical Research Council Population Health Research Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gillie', 'Affiliation': 'Health Research Forum, London, UK.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Nazareth', 'Affiliation': 'Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': 'Barts Clinical Trials Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Martineau', 'Affiliation': 'Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Peto', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24100']
721,32149378,Effectiveness of Sexual Skills Training Program on Promoting Sexual Intimacy and Satisfaction in Women in Tehran (Iran): A randomized clinical Trial Study.,"PURPOSE


The purpose of this study was to evaluate the effectiveness of sexual skills training on intimacy and sexual satisfaction in women.
MATERIALS AND METHODS


This is a randomized clinical trial study with parallel design. 70 participants (n=35 each) were divided into 2 groups as control and intervention groups. Women were selected in multiple steps. Some requirements for inclusion criteria were: obtaining a standard score of marital satisfaction, women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian. Some factors for exclusion criteria were: women's absence in more than 2 training classes, pregnancy during the study. Data collection was conducted through four questionnaires: demographic characteristics, marital satisfaction, sexual satisfaction and sexual intimacy. Validity and reliability of the questionnaires were measured through content validity and Chronbach Alpha, respectively. The data extracted from the questionnaires were analyzed using SPSS software, version 18.0. For data analysis, descriptive statistics, independent t-test, paired t-test, or non-parametric tests were applied. Significance level of the test was considered p<0.05.
RESULTS


The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
CONCLUSION


In total, the training lessons gave positive views to participants towards their sexual issues so that they formed realistic and positive sexual expectations, healthier sexual behaviors and self-expressions and consequently, gained more sexual knowledge that made them able to experience more intimacy and satisfaction in sexual relationships with their spouses.",2020,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","['women', 'Women in Tehran (Iran', 'women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian', '70 participants (n=35 each']","['Sexual Skills Training Program', 'sexual skills training']","['intimacy and sexual satisfaction', 'sexual satisfaction (p<0.001) and sexual intimacy', 'Sexual Intimacy and Satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",70.0,0.054477,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Salehi Moghaddam', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. fatemehsalehi28@yahoo.com.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'TorkZahrani', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Moslemi', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Arak University of Medical Sciences ,Arak, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Azin', 'Affiliation': 'MD, MPH, FECSM, Reproductive Biotechnology Research Center, Avicenna Research Institute, \nACECR, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Ozgoli', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Joulaee Rad', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4690']
722,31456562,Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT.,"BACKGROUND


A total of 25,000 people in the UK have osteoporotic vertebral fracture (OVF). Evidence suggests that physiotherapy may have an important treatment role.
OBJECTIVE


The objective was to investigate the clinical effectiveness and cost-effectiveness of two different physiotherapy programmes for people with OVF compared with a single physiotherapy session.
DESIGN


This was a prospective, adaptive, multicentre, assessor-blinded randomised controlled trial (RCT) with nested qualitative and health economic studies.
SETTING


This trial was based in 21 NHS physiotherapy departments.
PARTICIPANTS


The participants were people with symptomatic OVF.
INTERVENTIONS


Seven sessions of either manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT).
MAIN OUTCOME MEASURES


Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test, respectively. Secondary outcomes were (1) thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version.
RESULTS


A total of 615 participants were enrolled, with 216, 203 and 196 randomised by a computer-generated program to exercise therapy, manual therapy and a SSPT, respectively. Baseline data were available for 613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years). Primary outcome data were obtained for 69% of participants (429/615) at 12 months: 175 in the exercise therapy arm, 181 in the manual therapy arm and 173 in the SSPT arm. Interim analysis met the criteria for all arms to remain in the study. For the primary outcomes at 12 months, there were no significant benefits over SSPT of exercise [QUALEFFO-41, difference -0.23 points, 95% confidence interval (CI) -3.20 to 1.59 points;  p  = 1.000; and TLS test, difference 5.77 seconds, 95% CI -4.85 to 20.46 seconds;  p  = 0.437] or of manual therapy (QUALEFFO-41, difference 1.35 points, 95% CI -1.76 to 2.93 points;  p  = 0.744; TLS test, difference 9.69 seconds (95% CI 0.09 to 24.86 seconds;  p  = 0.335). At 4 months, there were significant gains for both manual therapy and exercise therapy over SSPT in the TLS test in participants aged < 70 years. Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT. Neither manual therapy nor exercise therapy was cost-effective relative to a SSPT using the threshold of £20,000 per quality-adjusted life-year. There were no treatment-related serious adverse events.
CONCLUSIONS


This is the largest RCT to date assessing physiotherapy in participants with OVFs. At 1 year, neither treatment intervention conferred more benefit than a single 1-hour physiotherapy advice session. The focus of future work should be on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN49117867.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 44. See the NIHR Journals Library website for further project information.",2019,"Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT.","['25,000 people in the UK have osteoporotic vertebral fracture (OVF', 'The participants were people with symptomatic OVF', '21 NHS physiotherapy departments', 'people with OVF compared with a single physiotherapy session', 'participants aged <\u200970 years', 'participants with OVFs', '613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years', '615 participants were enrolled, with 216, 203 and 196 randomised by a']","['manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT', 'Exercise therapy', 'Exercise or manual physiotherapy', 'computer-generated program to exercise therapy, manual therapy and a SSPT', 'manual therapy nor exercise therapy']","['confidence interval (CI', 'quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test', 'thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version', 'clinical effectiveness and cost-effectiveness']","[{'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C4517625', 'cui_str': '196'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}]","[{'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0034380'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0022823'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",615.0,0.18653,"Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Minns Lowe', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Muhammad K', 'Initials': 'MK', 'LastName': 'Javaid', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Noufaily', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Adhikari', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23440']
723,30703667,"Two- and three-year follow-up from a gender-specific, web-based drug abuse prevention program for adolescent girls.","INTRODUCTION


Rates of drug use among early adolescent girls meet or exceed rates of their male counterparts. Girls are also vulnerable to differential risk factors for drug use. Yet, expressly designed prevention programs targeting this population are absent. The present study reports 2- and 3-year findings on a web-based drug abuse prevention program for adolescent girls.
METHODS


A sample of adolescent girls (N = 788) were recruited via Facebook. Online, all girls completed pretests; girls were randomly assigned to a 9-session intervention arm or to a measurement-only control arm and all girls completed posttests. All girls also completed 1-, 2-, and 3-year follow-up measurements.
RESULTS


At 2-year follow-up and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette, marijuana, and ""other"" drug use (club drugs, cocaine, ecstasy, hallucinogens, heroin, inhalants, methamphetamines, steroids, prescription drugs), lower rates of peer drug use, and increased scores on drug refusal skills, coping skills, self-esteem, media literacy, and self-efficacy. At 3-year follow-up, and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image.
CONCLUSIONS


Longitudinal outcome data lend support to the efficacy of a gender-specific, web-based drug abuse prevention program to reduce adolescent girls' drug use rates and associated risk factors.",2019,"At 3-year follow-up, and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image.
","['early adolescent girls', 'adolescent girls', 'A sample of adolescent girls (N\u202f=\u202f788) were recruited via Facebook']","['9-session intervention arm or to a measurement-only control arm and all girls completed posttests', 'web-based drug abuse prevention program']","['drug refusal skills, coping skills, self-esteem, media literacy, and self-efficacy', 'past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1171189', 'cui_str': 'Drug abuse prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]",788.0,0.0291591,"At 3-year follow-up, and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image.
","[{'ForeName': 'Traci Marie', 'Initials': 'TM', 'LastName': 'Schwinn', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Ave, NY, NY 10027, USA. Electronic address: tms40@columbia.edu.'}, {'ForeName': 'Steven Paul', 'Initials': 'SP', 'LastName': 'Schinke', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Ave, NY, NY 10027, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Keller', 'Affiliation': 'Teachers College, Columbia University, 525 West 120th St., New York, NY 10027, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hopkins', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Ave, NY, NY 10027, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.01.010']
724,30809978,A Phase I Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Adults With Severe Renal Impairment and Healthy Matched Control Participants.,"This study investigates the impact of severe renal impairment on the pharmacokinetics of cabotegravir, an investigational HIV-1 integrase inhibitor. This was a phase I, open-label, parallel-group, multicenter study conducted in 8 participants with severe renal impairment (creatinine clearance <30 mL/min; no renal replacement therapy) and 8 healthy participants (creatinine clearance >90 mL/min; 2 women/group; 6 men/group) matched for sex, age (±10 years), and body mass index (±25%). Participants received a single 30-mg oral cabotegravir tablet to determine total and unbound plasma cabotegravir concentrations. Arithmetic and geometric least squares means were calculated, and cabotegravir noncompartmental pharmacokinetic parameters were compared using geometric least squares mean ratios with 90% confidence intervals. Safety was assessed throughout the study. Geometric least squares mean ratios (90% confidence intervals) were 0.97 (0.84-1.14) for area under the plasma concentration-time curve extrapolated to infinity, 1.01 (0.87-1.17) for maximum observed plasma concentration, 1.31 (0.84-2.03) for unbound cabotegravir 2 hours after dosing, and 1.51 (1.19-1.92) for unbound cabotegravir 24 hours after dosing. All adverse events were grade 1, except grade 3 lipase elevation in a participant with renal impairment. Severe renal impairment did not impact plasma cabotegravir exposure, and cabotegravir may be administered without dose adjustment in renal impairment among patients not receiving renal replacement.",2019,"Geometric least squares mean ratios (90% confidence intervals) were 0.97 (0.84-1.14) for area under the plasma concentration-time curve extrapolated to infinity, 1.01 (0.87-1.17) for maximum observed plasma concentration, 1.31 (0.84-2.03) for unbound cabotegravir 2 hours after dosing, and 1.51 (1.19-1.92) for unbound cabotegravir 24 hours after dosing.","['Adults With Severe Renal Impairment and Healthy Matched Control Participants', '8 participants with severe renal impairment (creatinine clearance', '8 healthy participants (creatinine clearance', 'patients not receiving renal replacement']",['Cabotegravir'],"['Severe renal impairment', 'Arithmetic and geometric least squares means', 'plasma concentration', 'Safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}]",[{'cui': 'C4310385'}],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",8.0,0.043854,"Geometric least squares mean ratios (90% confidence intervals) were 0.97 (0.84-1.14) for area under the plasma concentration-time curve extrapolated to infinity, 1.01 (0.87-1.17) for maximum observed plasma concentration, 1.31 (0.84-2.03) for unbound cabotegravir 2 hours after dosing, and 1.51 (1.19-1.92) for unbound cabotegravir 24 hours after dosing.","[{'ForeName': 'Ridhi', 'Initials': 'R', 'LastName': 'Parasrampuria', 'Affiliation': 'GlaxoSmithKline, Upper Merion, PA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Ford', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, PA, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'PAREXEL International, Durham, PA, USA.'}, {'ForeName': 'Caifeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'PAREXEL International, Durham, PA, USA.'}, {'ForeName': 'Kalpana K', 'Initials': 'KK', 'LastName': 'Bakshi', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, PA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Trezza', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, PA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Spreen', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, PA, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, PA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.664']
725,32057131,Imaginator: A Proof-of-Concept Feasibility Trial of a Brief Imagery-Based Psychological Intervention for Young People Who Self-Harm.,"OBJECTIVES


The Imaginator study tested the feasibility of a short mental imagery-based psychological intervention for young people who self-harm and used a stepped-wedge design to investigate effects on self-harm frequency reduction at 3 and 6 months.
METHOD


A total of 38 participants aged 16-25 were recruited via community self-referral and mental health services. Participants were randomized to immediate delivery of Functional Imagery Training (FIT) or usual care followed by delayed delivery after 3 months. FIT comprised two face-to-face sessions, five phone sessions, and use of a smartphone app. Outcomes' assessment was blind to allocation.
RESULTS


Three quarters of those who began treatment completed face-to-face sessions, and 57% completed five or more sessions in total. Self-harm frequency data were obtained on 76% of the sample at 3 months (primary outcome) and 63% at 6 months. FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75). The Immediate FIT group maintained improvements from 3 to 6 months (d = 0.05). Participants receiving usual care also reduced self-harm (d = 0.47).
CONCLUSIONS


A brief mental imagery-based psychological intervention targeting self-harm in young people is feasible and may comprise a novel transdiagnostic treatment for self-harm.",2020,FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75).,"['young people', 'Young People', 'Participants receiving usual care also reduced self-harm (d\xa0=\xa00.47', '38 participants aged 16-25 were recruited via community self-referral and mental health services', 'Imaginator', 'young people who self-harm']","['mental imagery-based psychological intervention', 'Brief Imagery-Based Psychological Intervention', 'short mental imagery-based psychological intervention', 'Functional Imagery Training (FIT) or usual care followed by delayed delivery after 3\xa0months']",[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0237824', 'cui_str': 'Self-referral (procedure)'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0235863', 'cui_str': 'Delayed delivery'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],38.0,0.0348264,FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75).,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Di Simplicio', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Appiah-Kusi', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Meiser-Stedman', 'Affiliation': 'Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': ""Centre for Children's Health Research, School of Psychology & Counselling, Institute of Health & Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12620']
726,30256537,"A Phase 1 Assessment of the QT Interval in Healthy Adults Following Exposure to Rolapitant, a Cancer Supportive Care Antiemetic.","This 2-part study evaluated the QT/QTc prolongation potential and safety and pharmacokinetics of the antiemetic rolapitant, a neurokinin-1 receptor antagonist. Part 1 was a randomized, placebo-controlled single-dose-escalation study assessing the safety of a single high dose of rolapitant. Part 2 was a randomized, placebo- and positive-controlled, double-blind parallel-group study including 4 treatment arms: rolapitant at the highest safe dose established in part 1, placebo, moxifloxacin 400 mg (positive control), and rolapitant at the presumed therapeutic dose (180 mg). Among 184 adults, rolapitant was absorbed following oral administration under fasting conditions, with a median T max  of 4 to 6 hours (range, 2-8 hours) and was safe at all doses up to 720 mg. No differences in mean change in QTcF were observed between placebo and rolapitant from baseline or at any point. At any point, the upper bound of the confidence interval for the mean difference between placebo and rolapitant was no greater than 4.4 milliseconds, and the mean difference between placebo and rolapitant was no greater than 1.7 milliseconds, suggesting an insignificant change in QTc with rolapitant. Rolapitant is safe and does not prolong the QT interval at doses up to 720 mg relative to placebo in healthy adults.",2019,Rolapitant is safe and does not prolong the QT interval at doses up to 720 mg relative to placebo in healthy adults.,"['healthy adults', 'Healthy Adults', '184 adults']","['placebo, moxifloxacin 400 mg (positive control), and rolapitant at the presumed therapeutic dose', 'placebo']","['mean change in QTcF', 'QT/QTc prolongation potential and safety and pharmacokinetics']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3273719', 'cui_str': 'rolapitant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.382023,Rolapitant is safe and does not prolong the QT interval at doses up to 720 mg relative to placebo in healthy adults.,"[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'TESARO, Waltham, MA, USA.'}, {'ForeName': 'Zhi-Yi', 'Initials': 'ZY', 'LastName': 'Zhang', 'Affiliation': 'TESARO, Waltham, MA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'TESARO, Waltham, MA, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kansra', 'Affiliation': 'TESARO, Waltham, MA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.619']
727,30329224,Pharmacokinetics of a Lobeglitazone/Metformin Fixed-Dose Combination Tablet (CKD-395 0.5/1000 mg) Versus Concomitant Administration of Single Agents and the Effect of Food on the Metabolism of CKD-395 in Healthy Male Subjects.,"This study aimed to compare the pharmacokinetic profile of combined CKD-395 0.5/1000 mg treatment with that of the coadministration of lobeglitazone sulfate 0.5 mg and metformin hydrochloride (HCl) extended-release (XR) 1000 mg and assess the effect of food on the pharmacokinetics of CKD-395 0.5/1000 mg. Two clinical trials were conducted as part of an open-label, single-dose, randomized, 2-period, 2-sequence crossover study. In study 1, a total of 26 subjects received either CKD-395 0.5/1000 mg as a test drug or coadministration of lobeglitazone sulfate 0.5 mg and metformin HCl XR 1000 mg individually as a reference treatment under fed conditions. In study 2, a total of 16 subjects received CKD-395 0.5/1000 mg treatment under either fasted or fed conditions. Blood samples were collected at intervals from 0 to 48 hours. In study 1, the geometric mean ratios and 90% confidence intervals of pharmacokinetic parameters for lobeglitazone and metformin were all within 80%-125% in the fed condition. In study 2, there were no high-fat meal effects on the area under the curve extending up to the last sampling time (AUC last  ) of lobeglitazone, but there was a decrease in the maximum plasma concentration (C max  ) of lobeglitazone by approximately 32% in the fed condition. Although the AUC last  of metformin increased by approximately 70% in the fed condition, there was no effect of food on the C max  of metformin, which is consistent with the already-established food effect on metformin HCl XR. No adverse drug reactions or serious adverse events were observed. This study suggests that CKD-395 0.5/1000 mg exhibits similar exposure and absorption rates to coadministration of single agents and is well tolerated under both fasted and fed conditions.",2019,No adverse drug reactions or serious adverse events were observed.,['Healthy Male Subjects'],"['lobeglitazone and metformin', 'combined CKD-395', 'metformin', 'CKD-395 0.5/1000 mg treatment under either fasted or fed conditions', 'CKD-395 0.5/1000\xa0mg as a test drug or coadministration of lobeglitazone sulfate 0.5\xa0mg and metformin HCl XR', 'lobeglitazone sulfate 0.5\xa0mg and metformin hydrochloride (HCl', 'Lobeglitazone/Metformin Fixed-Dose Combination Tablet']","['maximum plasma concentration (C max  ) of lobeglitazone', 'Blood samples', 'adverse drug reactions or serious adverse events', 'geometric mean ratios and 90% confidence intervals of pharmacokinetic parameters']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",26.0,0.0388741,No adverse drug reactions or serious adverse events were observed.,"[{'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Shin Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Research Institute, Chong Kun Dang Pharmaceutical Corp., Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.625']
728,31380892,Effect of a Professional Coaching Intervention on the Well-being and Distress of Physicians: A Pilot Randomized Clinical Trial.,"Importance


Burnout symptoms among physicians are common and have potentially serious ramifications for physicians and their patients. Randomized studies testing interventions to address burnout have been uncommon.
Objective


To explore the effect of individualized coaching on the well-being of physicians.
Design, Setting, and Participants


A pilot randomized clinical trial involving 88 practicing physicians in the departments of medicine, family medicine, and pediatrics who volunteered for coaching was conducted between October 9, 2017, and March 27, 2018, at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin. Statistical analysis was conducted from August 24, 2018, to March 25, 2019.
Interventions


A total of 6 coaching sessions facilitated by a professional coach.
Main Outcomes and Measures


Burnout, quality of life, resilience, job satisfaction, engagement, and meaning at work using established metrics. Analysis was performed on an intent-to-treat basis.
Results


Among the 88 physicians in the study (48 women and 40 men), after 6 months of professional coaching, emotional exhaustion decreased by a mean (SD) of 5.2 (8.7) points in the intervention group compared with an increase of 1.5 (7.7) points in the control group by the end of the study (P < .001). Absolute rates of high emotional exhaustion at 5 months decreased by 19.5% in the intervention group and increased by 9.8% in the control group (-29.3% [95% CI, -34.0% to -24.6%]) (P < .001). Absolute rates of overall burnout at 5 months also decreased by 17.1% in the intervention group and increased by 4.9% in the control group (-22.0% [95% CI, -25.2% to -18.7%]) (P < .001). Quality of life improved by a mean (SD) of 1.2 (2.5) points in the intervention group compared with 0.1 (1.7) points in the control group (1.1 points [95% CI, 0.04-2.1 points]) (P = .005), and resilience scores improved by a mean (SD) of 1.3 (5.2) points in the intervention group compared with 0.6 (4.0) points in the control group (0.7 points [95% CI, 0.0-3.0 points]) (P = .04). No statistically significant differences in depersonalization, job satisfaction, engagement, or meaning in work were observed.
Conclusions and Relevance


Professional coaching may be an effective way to reduce emotional exhaustion and overall burnout as well as improve quality of life and resilience for some physicians.
Trial Registration


ClinicalTrials.gov identifier: NCT03207581.",2019,"Quality of life improved by a mean (SD) of 1.2 (2.5) points in the intervention group compared with 0.1 (1.7) points in the control group (1.1 points [95% CI, 0.04-2.1 points]) (P = .005), and resilience scores improved by a mean (SD) of 1.3 (5.2) points in the intervention group compared with 0.6 (4.0) points in the control group (0.7 points [95% CI, 0.0-3.0 points]) (P = .04).","['88 physicians in the study (48 women and 40 men', 'Well-being and Distress of Physicians', '88 practicing physicians in the departments of medicine, family medicine, and pediatrics who volunteered for coaching was conducted between October 9, 2017, and March 27, 2018, at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin']","['Professional Coaching Intervention', 'individualized coaching']","['Quality of life', 'Absolute rates of high emotional exhaustion', 'Measures\n\n\nBurnout, quality of life, resilience, job satisfaction, engagement, and meaning at work using established metrics', 'professional coaching, emotional exhaustion', 'resilience scores', 'quality of life and resilience', 'depersonalization, job satisfaction, engagement, or meaning in work', 'Absolute rates of overall burnout']","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0003787', 'cui_str': 'Arizona'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",48.0,0.185465,"Quality of life improved by a mean (SD) of 1.2 (2.5) points in the intervention group compared with 0.1 (1.7) points in the control group (1.1 points [95% CI, 0.04-2.1 points]) (P = .005), and resilience scores improved by a mean (SD) of 1.3 (5.2) points in the intervention group compared with 0.6 (4.0) points in the control group (0.7 points [95% CI, 0.0-3.0 points]) (P = .04).","[{'ForeName': 'Liselotte N', 'Initials': 'LN', 'LastName': 'Dyrbye', 'Affiliation': 'Department of Medicine, Program on Physician Well-Being, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tait D', 'Initials': 'TD', 'LastName': 'Shanafelt', 'Affiliation': 'Department of Medicine, WellMD Center, Stanford School of Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Priscilla R', 'Initials': 'PR', 'LastName': 'Gill', 'Affiliation': 'Workforce Learning, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Satele', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'West', 'Affiliation': 'Department of Medicine, Program on Physician Well-Being, Mayo Clinic, Rochester, Minnesota.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.2425']
729,31296516,"ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol.","INTRODUCTION


Pelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related to the challenges of appropriate pain control and early mobilisation. The current standard for treatment of PFF is non-surgical management. Minimally invasive surgical techniques for sacral fracture stabilisation have been shown to improve outcomes in terms of pain control and mobility, and they are safe. Randomised controlled trials are required before recommendations can be made for surgical management of PFF to become the new standard of care. This feasibility study will explore several uncertainties around conducting such a trial.
METHODS AND ANALYSIS


ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) is a single-site randomised controlled, parallel-arm, feasibility trial of surgical stabilisation versus non-surgical management of acute sacral fragility fractures in people aged 70 years and over. Patients will be randomised to either surgical or non-surgical group on a 1:1 ratio. Follow-up of participants will occur at 2, 4 and 12 weeks with safety data collected at 52 weeks. Primary objectives are to determine feasibility and design of a future trial, including outcomes on recruitment, adherence to randomisation and safety. This will be supplemented with a qualitative interview study of participants and clinicians. Secondary objectives will inform study design procedures to determine clinical and economic outcomes between groups, including scored questionnaires, analgesia requirements, resource use and quality of life data. Data analysis will be largely descriptive to inform outcomes and future sample size.
ETHICS AND DISSEMINATION


Ethical approval was granted by the North East Newcastle and North Tyneside 2 Research Ethics Committee (reference 18/NE/0212). ASSERT was approved and sponsored by Nottingham University Hospitals NHS Trust (reference 18HC001) and the Health Research Authority (reference IRAS 232791). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals on study completion.
TRIAL REGISTRATION NUMBER


ISRCTN16719542; Pre-results.",2019,"Minimally invasive surgical techniques for sacral fracture stabilisation have been shown to improve outcomes in terms of pain control and mobility, and they are safe.","['older people trial', 'acute sacral fragility fractures in people aged 70 years and over']","['PFF', 'surgical stabilisation versus non-surgical management', 'surgical or non-surgical']","['scored questionnaires, analgesia requirements, resource use and quality of life data']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0302113', 'cui_str': 'Fragility, function (observable entity)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}]",,0.202656,"Minimally invasive surgical techniques for sacral fracture stabilisation have been shown to improve outcomes in terms of pain control and mobility, and they are safe.","[{'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'van Berkel', 'Affiliation': 'Health Care of the Older People Division, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Ong', 'Affiliation': 'Health Care of the Older People Division, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hendrick', 'Affiliation': 'Division of Physiotherapy and Rehabilitation Sciences, School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leighton', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Salem', 'Affiliation': 'Centre for Spinal Studies and Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Quraishi', 'Affiliation': 'Centre for Spinal Studies and Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Suazo Di Paola', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Opinder', 'Initials': 'O', 'LastName': 'Sahota', 'Affiliation': 'Health Care of the Older People Division, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032111']
730,30240132,Pharmacokinetics and Safety of CSL112 (Apolipoprotein A-I [Human]) in Adults With Moderate Renal Impairment and Normal Renal Function.,"CSL112 (Apolipoprotein A-I [human]) is an intravenous preparation of apolipoprotein A-I (apoA-I), formulated with phosphatidylcholine (PC) and stabilized with sucrose, in development to prevent early recurrent cardiovascular events following acute myocardial infarction (AMI). This phase 1 study was designed to determine if moderate renal impairment (RI) influenced the pharmacokinetics (PK) and safety of CSL112. Thirty-two subjects, 16 with moderate RI (estimated glomerular filtration rate [eGFR] ≥ 30 and < 60 mL/min/1.73 m 2  ) and 16 age-, sex-, and weight-matched subjects with normal renal function (eGFR ≥ 90 mL/min/1.73 m 2  ) were randomized 3:1 to receive a single infusion of CSL112 2 g (n = 6) or placebo (n = 2), or CSL112 6 g (n = 6) or placebo (n = 2). PK sampling was at prespecified times from 48 hours prior to 144 hours following infusions, with final safety assessments at 90 days. Renal and hepatic safety, and adverse events (AEs) were monitored throughout the study. Plasma apoA-I and PC PK profiles were similar between renal function cohorts at both doses. For CSL112 6 g mean ± SD apoA-I AUC 0   -   last  was 7670 ± 1900 and 9170 ± 2910 mg·h/dL in normal renal function and moderate RI subjects, respectively. Renal apoA-I clearance was <1% of CSL112 dose. In moderate RI, sucrose clearance was slower; however, approximately 70% was excreted within 48 hours in both renal function cohorts. No CSL112-related serious AEs or clinically significant renal or hepatic safety changes were observed. Dose adjustment of CSL112 is not required in subjects with moderate RI, supporting its further investigation in AMI patients with moderate RI.",2019,No CSL112-related serious AEs or clinically significant renal or hepatic safety changes were observed.,"['acute myocardial infarction (AMI', 'Thirty-two subjects, 16 with moderate RI (estimated glomerular filtration rate [eGFR] ≥ 30 and < 60 mL/min/1.73 m 2  ) and 16 age-, sex-, and', 'Adults With Moderate Renal Impairment and Normal Renal Function', 'AMI patients with moderate RI', 'weight-matched subjects with normal renal function (eGFR ≥ 90 mL/min/1.73 m 2  ']","['CSL112', 'CSL112 ', 'placebo', 'phosphatidylcholine (PC) and stabilized with sucrose', 'CSL112 (Apolipoprotein A-I [Human', 'Apolipoprotein A-I [human', 'CSL112 6 g (n = 6) or placebo']","['Renal and hepatic safety, and adverse events (AEs', 'Plasma apoA-I and PC PK profiles', 'mean ± SD', 'renal or hepatic safety changes', 'moderate renal impairment (RI) influenced the pharmacokinetics (PK) and safety of CSL112', 'Renal apoA']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C3712106', 'cui_str': 'CSL112'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1959616', 'cui_str': 'Phosphatidyl Cholines'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0622790', 'cui_str': 'Apo A-I (Giessen)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0756567', 'cui_str': 'apoA-I(Zavalla)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3712106', 'cui_str': 'CSL112'}, {'cui': 'C0003592', 'cui_str': 'Apo-A'}]",,0.0568099,No CSL112-related serious AEs or clinically significant renal or hepatic safety changes were observed.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Tortorici', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Duffy', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Feaster', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gille', 'Affiliation': 'CSL Limited, Parkville, Australia.'}, {'ForeName': 'Timothy G K', 'Initials': 'TGK', 'LastName': 'Mant', 'Affiliation': 'IQIVA, Reading, UK.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Wright', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': ""D'Andrea"", 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.618']
731,31843338,Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial.,"BACKGROUND


BC2001, the largest randomised trial of bladder-sparing treatment for muscle-invasive bladder cancer, demonstrated improvement of local control and bladder cancer-specific survival from the addition of concomitant 5-fluorouracil and mitomycin C to radiotherapy.
OBJECTIVE


To determine the impact of treatment on the health-related quality of life (HRQoL) of BC2001 participants.
DESIGN, SETTING, AND PARTICIPANTS


458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder.
INTERVENTION


Patients were randomised to the chemotherapy comparison (radiotherapy, 178, or chemoradiotherapy, 182); and/or to the radiotherapy comparison (standard, 108, or reduced high-dose volume radiotherapy, 111).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Patients completed Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires at baseline, end of treatment (EoT), and 6, 12, 24, 36, 48, and 60 months after radiotherapy. The primary endpoint was change from baseline in the bladder cancer subscale (BLCS) at 12 months.
RESULTS AND LIMITATIONS


Data were available for 331 (92%) and 204 (93%) participants at baseline and for 192 (54%) and 114 (52%) at 12 months for the chemotherapy and radiotherapy comparisons, respectively. HRQoL declined at EoT (BLCS -5.06 [99% confidence interval: -6.12 to -4.00, p< 0.001]; overall FACT-B TOTAL score -8.22 [-10.76 to -5.68, p< 0.01]), recovering to baseline at 6 months and remaining similar to baseline subsequently. There was no significant difference between randomised groups at any time point.
CONCLUSIONS


Immediately following (chemo)radiotherapy, a significant proportion of patients report declines in HRQoL, which improve to baseline after 6 months. Two-thirds of patients report stable or improved HRQoL on long-term follow-up. There is no evidence of impairment in HRQoL resulting from the addition of chemotherapy.
PATIENT SUMMARY


Quality of life of bladder cancer patients treated with radiotherapy±chemotherapy deteriorates during treatment, but improves to at least pretreatment levels within 6 months. Addition of chemotherapy to radiotherapy does not affect patient-reported quality of life.",2020,"There was no significant difference between randomised groups at any time point.
","['458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder', 'muscle-invasive bladder cancer', 'Patients Treated for Muscle-invasive Bladder Cancer with', 'bladder cancer patients treated with', ' 178, or chemoradiotherapy, 182']","['bladder-sparing treatment', 'chemotherapy to radiotherapy', 'radiotherapy±chemotherapy deteriorates', 'Radiotherapy ± Chemotherapy', '5-fluorouracil and mitomycin C to radiotherapy', 'chemotherapy comparison (radiotherapy']","['bladder cancer subscale (BLCS', 'Quality of Life Outcomes', 'Quality of life', 'HRQoL', 'local control and bladder cancer-specific survival', 'quality of life', 'Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",458.0,0.462282,"There was no significant difference between randomised groups at any time point.
","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Huddart', 'Affiliation': 'The Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK. Electronic address: Robert.Huddart@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Crundwell', 'Affiliation': 'Royal Devon & Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Jenkins', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rawlings', 'Affiliation': 'Torbay and South Devon NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Tremlett', 'Affiliation': 'Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Campani', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hendron', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Academic unit of Oncology, Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'University of Birmingham, Birmingham, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.11.001']
732,31504709,Whole Grain Wheat Consumption Affects Postprandial Inflammatory Response in a Randomized Controlled Trial in Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study.,"BACKGROUND


Whole grain wheat (WGW) consumption is associated with health benefits in observational studies. However, WGW randomized controlled trial (RCT) studies show mixed effects.
OBJECTIVES


The health impact of WGW consumption was investigated by quantification of the body's resilience, which was defined as the ""ability to adapt to a standardized challenge.""
METHODS


A double-blind RCT was performed with overweight and obese (BMI: 25-35 kg/m2) men (n = 19) and postmenopausal women (n = 31) aged 45-70 y, with mildly elevated plasma total cholesterol (>5 mmol/L), who were randomly assigned to either 12-wk WGW (98 g/d) or refined wheat (RW). Before and after the intervention a standardized mixed-meal challenge was performed. Plasma samples were taken after overnight fasting and postprandially (30, 60, 120, and 240 min). Thirty-one biomarkers were quantified focusing on metabolism, liver, cardiovascular health, and inflammation. Linear mixed-models evaluated fasting compared with postprandial intervention effects. Health space models were used to evaluate intervention effects as composite markers representing resilience of inflammation, liver, and metabolism.
RESULTS


Postprandial biomarker changes related to liver showed decreased alanine aminotransferase by WGW (P = 0.03) and increased β-hydroxybutyrate (P = 0.001) response in RW. Postprandial changes related to inflammation showed increased C-reactive protein (P = 0.001), IL-6 (P = 0.02), IL-8 (P = 0.007), and decreased IL-1B (P = 0.0002) in RW and decreased C-reactive protein (P < 0.0001), serum amyloid A (P < 0.0001), IL-8 (P = 0.02), and IL-10 (P < 0.0001) in WGW. Health space visualization demonstrated diminished inflammatory (P < 0.01) and liver resilience (P < 0.01) by RW, whereas liver resilience was rejuvenated by WGW (P < 0.05).
CONCLUSIONS


Twelve-week 98 g/d WGW consumption can promote liver and inflammatory resilience in overweight and obese subjects with mildly elevated plasma cholesterol. The health space approach appeared appropriate to evaluate intervention effects as composite markers. This trial was registered at www.clinicaltrials.gov as NCT02385149.",2019,"Postprandial changes related to inflammation showed increased C-reactive protein (P = 0.001), IL-6","['Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study', 'overweight and obese subjects with mildly elevated plasma cholesterol', 'overweight and obese (BMI: 25-35 kg/m2) men (n\xa0=\xa019) and postmenopausal women (n\xa0=\xa031) aged 45-70 y, with mildly elevated plasma total cholesterol (>5 mmol/L']","['RCT', 'Whole Grain Wheat Consumption', 'Whole grain wheat (WGW) consumption']","['liver resilience', 'IL-6', 'IL-10', 'β-hydroxybutyrate', 'RW and decreased C-reactive protein', 'IL-1B', 'alanine aminotransferase by WGW', 'C-reactive protein', 'metabolism, liver, cardiovascular health, and inflammation', 'serum amyloid', 'IL-8']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",,0.317179,"Postprandial changes related to inflammation showed increased C-reactive protein (P = 0.001), IL-6","[{'ForeName': 'Femke P M', 'Initials': 'FPM', 'LastName': 'Hoevenaars', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Esser', 'Affiliation': 'Wageningen University, Division of Human Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schutte', 'Affiliation': 'Wageningen University, Division of Human Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Marion G', 'Initials': 'MG', 'LastName': 'Priebe', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Medical Biomics, Groningen, Netherlands.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Vonk', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Medical Biomics, Groningen, Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'van den Brink', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'van der Kamp', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Johanna H M', 'Initials': 'JHM', 'LastName': 'Stroeve', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Lydia A', 'Initials': 'LA', 'LastName': 'Afman', 'Affiliation': 'Wageningen University, Division of Human Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxz177']
733,31390743,Evaluation of a Violence-Prevention Programme with Jamaican Primary School Teachers: A Cluster Randomised Trial.,"This study investigated the effect of a school-based violence prevention programme implemented in Grade 1 classrooms in Jamaican primary schools. Fourteen primary schools were randomly assigned to receive training in classroom behaviour management ( n  = 7 schools, 27 teachers/classrooms) or to a control group ( n  = 7 schools, 28 teachers/classrooms). Four children from each class were randomly selected to participate in the evaluation ( n  = 220 children). Teachers were trained through a combination of workshop and in-class support sessions, and received a mean of 11.5 h of training (range = 3-20) over 8 months. The primary outcomes were observations of (1) teachers' use of violence against children and (2) class-wide child aggression. Teachers in intervention schools used significantly less violence against children (effect size (ES) = -0.73); benefits to class-wide child aggression were not significant (ES = -0.20). Intervention teachers also provided a more emotionally supportive classroom environment (ES = 1.22). No benefits were found to class-wide prosocial behaviour, teacher wellbeing, or child mental health. The intervention benefited children's early learning skills, especially oral language and self-regulation skills (ES = 0.25), although no benefits were found to achievement in maths calculation, reading and spelling. A relatively brief teacher-training programme reduced violence against children by teachers and increased the quality of the classroom environment.",2019,"The intervention benefited children's early learning skills, especially oral language and self-regulation skills (ES = 0.25), although no benefits were found to achievement in maths calculation, reading and spelling.","['Jamaican Primary School Teachers', 'Grade 1 classrooms in Jamaican primary schools', 'Fourteen primary schools', 'Four children from each class were randomly selected to participate in the evaluation ( n  = 220 children']","['school-based violence prevention programme', 'training in classroom behaviour management']","['class-wide prosocial behaviour, teacher wellbeing, or child mental health', ""observations of (1) teachers' use of violence against children and (2) class-wide child aggression"", '0.73); benefits to class-wide child aggression', 'violence against children (effect size (ES) ', ""children's early learning skills, especially oral language and self-regulation skills""]","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150143', 'cui_str': 'Behavior modification case management'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]",220.0,0.0174584,"The intervention benefited children's early learning skills, especially oral language and self-regulation skills (ES = 0.25), although no benefits were found to achievement in maths calculation, reading and spelling.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Baker-Henningham', 'Affiliation': 'School of Psychology, Bangor University, Bangor LL57 2AS, UK. h.henningham@bangor.ac.uk.'}, {'ForeName': 'Yakeisha', 'Initials': 'Y', 'LastName': 'Scott', 'Affiliation': 'Caribbean Institute for Health Research, University of the West Indies, Kingston 7, Jamaica.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Bowers', 'Affiliation': 'Caribbean Institute for Health Research, University of the West Indies, Kingston 7, Jamaica.'}, {'ForeName': 'Taja', 'Initials': 'T', 'LastName': 'Francis', 'Affiliation': 'Caribbean Institute for Health Research, University of the West Indies, Kingston 7, Jamaica.'}]",International journal of environmental research and public health,['10.3390/ijerph16152797']
734,31345985,Patient experience and reflective learning (PEARL): a mixed methods protocol for staff insight development in acute and intensive care medicine in the UK.,"INTRODUCTION


Patient and staff experiences are strongly influenced by attitudes and behaviours, and provide important insights into care quality. Patient and staff feedback could be used more effectively to enhance behaviours and improve care through systematic integration with techniques for reflective learning. We aim to develop a reflective learning framework and toolkit for healthcare staff to improve patient, family and staff experience.
METHODS & ANALYSIS


Local project teams including staff and patients from the acute medical units (AMUs) and intensive care units (ICUs) of three National Health Service trusts will implement two experience surveys derived from existing instruments: a continuous patient and relative survey and an annual staff survey. Survey data will be supplemented by ethnographic interviews and observations in the workplace to evaluate barriers to and facilitators of reflective learning. Using facilitated iterative co-design, local project teams will supplement survey data with their experiences of healthcare to identify events, actions, activities and interventions which promote personal insight and empathy through reflective learning. Outputs will be collated by the central project team to develop a reflective learning framework and toolkit which will be fed back to the local groups for review, refinement and piloting. The development process will be mapped to a conceptual theory of reflective learning which combines psychological and pedagogical theories of learning, alongside theories of behaviour change based on capability, opportunity and motivation influencing behaviour. The output will be a locally-adaptable workplace-based toolkit providing guidance on using reflective learning to incorporate patient and staff experience in routine clinical activities.
ETHICS & DISSEMINATION


The PEARL project has received ethics approval from the London Brent Research Ethics Committee (REC Ref 16/LO/224). We propose a national cluster randomised step-wedge trial of the toolkit developed for large-scale evaluation of impact on patient outcomes.",2019,Patient and staff feedback could be used more effectively to enhance behaviours and improve care through systematic integration with techniques for reflective learning.,['Local project teams including staff and patients from the acute medical units (AMUs) and intensive care units (ICUs) of three National Health Service trusts will implement two experience surveys derived from existing instruments: a continuous patient and relative survey and an annual staff survey'],['reflective learning (PEARL'],[],"[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]",[],[],,0.066792,Patient and staff feedback could be used more effectively to enhance behaviours and improve care through systematic integration with techniques for reflective learning.,"[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Brookes', 'Affiliation': 'Research, Development & Innovation, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'Warwick Medical School (WMS), The University of Warwick, Warwick, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Tarrant', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Archer', 'Affiliation': 'Royal Australasian College of Surgeons, Melbourne, Victoria, Australia.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Buckley', 'Affiliation': 'Birmingham, UK.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Buckley', 'Affiliation': 'Birmingham, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Clement', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Evison', 'Affiliation': 'Department of Health Informatics, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Gao Smith', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gibbins', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hayton', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lilford', 'Affiliation': 'Division of Health and Population Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Mullhi', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Packer', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Perkins', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Birmingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shelton', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Snelson', 'Affiliation': 'Critical Care, University Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'CLAHRC, Imperial College, London, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, Coventry, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wolstenholme', 'Affiliation': 'NIHR CLAHRC Yorkshire and Humber, Sheffield, UK.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Anaesthesia, Newcastle upon Tyne Hospitals, Newcastle upon Tyne, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Bion', 'Affiliation': 'Intensive Care Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-030679']
735,31365529,Comparative evaluation of anesthetic efficacy of 1.8 mL and 3.6 mL of articaine in irreversible pulpitis of the mandibular molar: A randomized clinical trial.,"OBJECTIVE


The aim of this study was to compare the anesthetic efficacy of two volumes of articaine in conventional inferior alveolar nerve block (IANB) of mandibular molars with irreversible pulpitis, and in cases of anesthetic failure, its complementation with periodontal ligament injection (PDL).
METHODS


Ninety patients with irreversible pulpitis in mandibular molars received conventional IANB with 1.8 mL or 3.6 mL of 4% articaine with 1:100,000 epinephrine. In cases of IANB failure, the same volumes were administered in the PDL. Presence of pulpal anesthesia and absence/presence of pain during pulpectomy were evaluated by electric pulp stimulation and verbal analogue scale, respectively. Relative risks (RR) with corresponding 95% confidence intervals (95% CI) were calculated for each outcome.
RESULTS


27% and 42% of the patients achieved pulpal anesthesia following IANB with 1.8 mL and 3.6 mL, respectively (RR = 0.63, CI 95% 0.35 to 1.14, p = 0.12). Analgesia during pulpectomy was present in 64% and 73% of the patients, respectively, for 1.8 mL and 3.6 mL (RR = 0.87, CI 95% 0.66 to 1.16, p = 0.36). In cases of IANB failure, 75% and 42% of the patients that received 1.8 mL and 3.6 mL of PDL injection, respectively, achieved pulpal anesthesia (RR = 1.80, CI 95% 0.87 to 3.72, p = 0.11). During a new attempt at the pulpectomy procedure, analgesia was present in 69% and 75% of the patients, respectively, for 1.8 mL and 3.6 mL (RR = 0.91, CI 95% 0.57 to 1.45, p = 0.71).
CONCLUSION


Increasing the volume from 1.8 mL to 3.6 mL of the 4% articaine with 1:100,000 epinephrine in the IANB and in the PDL, did not significantly increase the success rate of pulpal anesthesia and clinical analgesia during the pulpectomy procedure. Therefore, both volumes presented a similar efficacy, though neither resulted in effective pain control during irreversible pulpitis treatment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02422823.",2019,"Analgesia during pulpectomy was present in 64% and 73% of the patients, respectively, for 1.8 mL and 3.6 mL (RR = 0.87, CI 95% 0.66 to 1.16, p = 0.36).","['Ninety patients with irreversible pulpitis in mandibular molars received', 'mandibular molars with irreversible pulpitis, and in cases of anesthetic failure, its complementation with periodontal ligament injection (PDL', 'irreversible pulpitis of the mandibular molar']","['conventional IANB with 1.8 mL or 3.6 mL of 4% articaine with 1:100,000 epinephrine', 'articaine', 'epinephrine']","['Analgesia', 'success rate of pulpal anesthesia and clinical analgesia', 'Relative risks (RR', 'pulpal anesthesia', 'anesthetic efficacy', 'effective pain control']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0399406', 'cui_str': 'Irreversible pulpitis'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031093', 'cui_str': 'Alveolodental Membrane'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",90.0,0.231997,"Analgesia during pulpectomy was present in 64% and 73% of the patients, respectively, for 1.8 mL and 3.6 mL (RR = 0.87, CI 95% 0.66 to 1.16, p = 0.36).","[{'ForeName': 'Stella Agra', 'Initials': 'SA', 'LastName': 'Silva', 'Affiliation': 'Department of Stomatology, São Paulo University, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, São Paulo, SP, Brazil.'}, {'ForeName': 'Cláudio Mendes', 'Initials': 'CM', 'LastName': 'Pannuti', 'Affiliation': 'Department of Stomatology, São Paulo University, São Paulo, SP, Brazil.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Braz-Silva', 'Affiliation': 'Department of Stomatology, São Paulo University, São Paulo, SP, Brazil.'}, {'ForeName': 'Carina Gisele Costa', 'Initials': 'CGC', 'LastName': 'Bispo', 'Affiliation': 'Department of Dentistry, Maringá State University, Maringá, Paraná, Brazil.'}, {'ForeName': 'Inês Aparecida', 'Initials': 'IA', 'LastName': 'Buscariolo', 'Affiliation': 'Department of Stomatology, São Paulo University, São Paulo, SP, Brazil.'}, {'ForeName': 'Rodney Garcia', 'Initials': 'RG', 'LastName': 'Rocha', 'Affiliation': 'Department of Stomatology, São Paulo University, São Paulo, SP, Brazil.'}, {'ForeName': 'Isabel Peixoto', 'Initials': 'IP', 'LastName': 'Tortamano', 'Affiliation': 'Department of Stomatology, São Paulo University, São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0219536']
736,31262768,"Safety, Pharmacokinetics, and Food Effect of Tebipenem Pivoxil Hydrobromide after Single and Multiple Ascending Oral Doses in Healthy Adult Subjects.","Tebipenem pivoxil hydrobromide (TBPM-PI-HBr, formerly SPR994) is an orally available prodrug of tebipenem, a carbapenem with activity versus multidrug-resistant (MDR) Gram-negative pathogens, including quinolone-resistant and extended-spectrum-β-lactamase-producing  Enterobacteriaceae  The safety and pharmacokinetics (PK) of tebipenem were studied after administration of single and multiple ascending oral doses of TBPM-PI-HBr in fed and fasted states. Healthy adults received single oral doses of TBPM-PI-HBr at 100 mg to 900 mg or placebo ( n  = 108) or multiple doses of 300 mg or 600 mg every 8 h or placebo ( n  = 16) for 14 days. In the single-ascending-dose (SAD) phase, mean tebipenem plasma concentrations increased in a linear and dose proportional manner for doses of 100 to 900 mg and were comparable in the fasted and fed states for the 300- and 600-mg doses. In the MAD phase, tebipenem maximum concentration ( C   max ) was reached within 1.5 h and was dose proportional on day 1 and higher than dose proportional (2.7-fold) on day 14. AUC was more than 2-fold greater on day 1 (2.7-fold) and day 14 (2.5-fold) for 600 mg q8h than for 300 mg q8h. Approximately 55% to 60% of tebipenem was recovered in the urine. TBPM-PI-HBr was well tolerated; mild, transient diarrhea was the most commonly reported adverse event. TBPM-PI-HBr provides an orally bioavailable carbapenem option to treat serious infections caused by MDR  Enterobacteriaceae  and has the potential to decrease the need for intravenous antibiotic therapy in the hospital or outpatient setting. (This study has been registered at ClinicalTrials.gov under identifier NCT03395249.).",2019,AUC was more than 2-fold greater on Day 1 (2.7 fold) and Day 14 (2.5 fold) for 600 mg q8h compared with 300 mg q8h.,"['Healthy adults', 'Healthy Adult Subjects']","['Tebipenem pivoxil hydrobromide (TBPM-PI-HBr, formerly SPR994', 'TBPM-PI-HBr 100 mg to 900 mg or placebo', 'Tebipenem Pivoxil Hydrobromide', 'placebo']","['safety and pharmacokinetics (PK) of tebipenem', 'Safety, Pharmacokinetics, and Food Effect', 'tebipenem C max', 'mean tebipenem plasma concentrations', 'TBPM-PI-HBr was well tolerated; mild, transient diarrhea']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1568612', 'cui_str': 'tebipenem'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1568612', 'cui_str': 'tebipenem'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.0861917,AUC was more than 2-fold greater on Day 1 (2.7 fold) and Day 14 (2.5 fold) for 600 mg q8h compared with 300 mg q8h.,"[{'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA peckburg@sperotherapeutics.com.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Walpole', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Grayson', 'Initials': 'G', 'LastName': 'Moore', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Utley', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Manyak', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Dane', 'Affiliation': 'DaneStat Consulting, Alderley Edge, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Melnick', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00618-19']
737,30863852,Healthcare Costs and Life-years Gained From Treatments Within the Advancing Cryptococcal Meningitis Treatment for Africa (ACTA) Trial on Cryptococcal Meningitis: A Comparison of Antifungal Induction Strategies in Sub-Saharan Africa.,"BACKGROUND


Mortality from cryptoccocal meningitis remains high. The ACTA trial demonstrated that, compared with 2 weeks of amphotericin B (AmB) plus flucystosine (5FC), 1 week of AmB and 5FC was associated with lower mortality and 2 weeks of oral flucanozole (FLU) plus 5FC was non-inferior. Here, we assess the cost-effectiveness of these different treatment courses.
METHODS


Participants were randomized in a ratio of 2:1:1:1:1 to 2 weeks of oral 5FC and FLU, 1 week of AmB and FLU, 1 week of AmB and 5FC, 2 weeks of AmB and FLU, or 2 weeks of AmB and 5FC in Malawi, Zambia, Cameroon, and Tanzania. Data on individual resource use and health outcomes were collected. Cost-effectiveness was measured as incremental costs per life-year saved, and non-parametric bootstrapping was done.
RESULTS


Total costs per patient were US $1442 for 2 weeks of oral FLU and 5FC, $1763 for 1 week of AmB and FLU, $1861 for 1 week of AmB and 5FC, $2125 for 2 weeks of AmB and FLU, and $2285 for 2 weeks of AmB and 5FC. Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective. The incremental cost-effectiveness ratio for 1 week of AmB and 5FC versus oral FLU and 5FC was US $208 (95% confidence interval $91-1210) per life-year saved.
CLINICAL TRIALS REGISTRATION


ISRCTN45035509.
CONCLUSIONS


Both 1 week of AmB and 5FC and 2 weeks of Oral FLU and 5FC are cost-effective treatments.",2019,"Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective.","['Africa (ACTA) Trial on Cryptococcal Meningitis', 'Sub-Saharan Africa', 'Participants']","['oral 5FC and FLU, 1 week of AmB and FLU, 1 week of AmB and 5FC, 2 weeks of AmB and FLU, or 2 weeks of AmB and 5FC in Malawi, Zambia, Cameroon, and Tanzania', 'AmB and 5FC versus oral FLU and 5FC', 'oral flucanozole (FLU) plus 5FC', 'amphotericin B (AmB) plus flucystosine (5FC']","['Healthcare Costs and Life-years', 'Cost-effectiveness', 'incremental cost-effectiveness ratio', 'cost-effectiveness']","[{'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0085436', 'cui_str': 'Meningitis, Cryptococcal'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0297931,"Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Mwenge', 'Affiliation': 'Zambart, Health Economics Unit, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Shabir', 'Initials': 'S', 'LastName': 'Lakhi', 'Affiliation': 'University Teaching Hospital, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Chanda', 'Affiliation': 'Institute for Medical Research and Training, University Teaching Hospital, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mwaba', 'Affiliation': 'Department of Internal Medicine and Directorate of Research and Post-Graduate Studies, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Síle F', 'Initials': 'SF', 'LastName': 'Molloy', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Gheorghe', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Ulla K', 'Initials': 'UK', 'LastName': 'Griffiths', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Heyderman', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Hôpital Central Yaoundé/Site Agence Nationale de Recherche sur le Sida Cameroun, Yaoundé Hopitaux de Paris, France.'}, {'ForeName': 'Sayoki', 'Initials': 'S', 'LastName': 'Mfinanga', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Adrienne K', 'Initials': 'AK', 'LastName': 'Chan', 'Affiliation': 'Dignitas International, Zomba Central Hospital, Malawi.'}, {'ForeName': 'Elvis', 'Initials': 'E', 'LastName': 'Temfack', 'Affiliation': 'Douala General Hospital, Cameroon.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'National Institute for Medical Research, Muhimbili Medical Research Centre, Dar Es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lortholary', 'Affiliation': 'Institut Pasteur, Molecular Mycology Unit, Paris, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Loyse', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Louis W', 'Initials': 'LW', 'LastName': 'Niessen', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy971']
738,31373374,"PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Contributes to Postpartum Weight Retention in Guatemala: A Cluster-Randomized Controlled Intervention Trial.","BACKGROUND


Food-assisted maternal and child health and nutrition (FA-MCHN) programs are widely used to reduce household food insecurity and maternal and child undernutrition in low- and middle-income countries. These programs, however, may unintentionally lead to excessive energy intake and unhealthy weight gain, especially in food-secure populations.
OBJECTIVE


We evaluated the impact of an FA-MCHN program implemented in Guatemala on maternal weight from pregnancy to 24 mo postpartum. The program was earlier shown to reduce stunting.
METHODS


We used a longitudinal, cluster-randomized controlled trial with arms varying in family ration size [full (FFR), reduced (RFR), none (NFR)] and individual maternal ration type [corn-soy blend (CSB), lipid-based nutrient supplement (LNS), micronutrient powder (MNP)]: A: FFR + CSB; B: RFR + CSB; C: NFR + CSB; D: FFR + LNS; E: FFR + MNP; F: control. Weight was measured during pregnancy and at 1, 4, 6, 9, 12, 18, and 24 mo postpartum. We used linear mixed models controlling for pregnancy weight with random cluster and mother effects. Data on 3535 women were analyzed.
RESULTS


Significant (P < 0.05) or marginally significant (P < 0.10) effects of 0.50-0.65 kg were found at all time points (except 9 mo) in arm A. Similar-sized effects were found in arms B (1, 4, 6, and 12 mo) and C (1 and 12 mo). Marginally significant effects (0.51-0.66 kg) were found in arm D (1, 6, 9, and 12 mo); in arm E, marginally significant effects (0.48-0.75 kg) were found from 6 to 24 mo.
CONCLUSIONS


The effect on maternal postpartum weight is of concern because of the high existing prevalence of overweight. Programs need to include ""double-duty"" objectives and actions, to ensure that addressing child undernutrition does not exacerbate the problem of unhealthy weight gain. This trial was registered at clinicaltrials.gov as NCT01072279.",2019,"Marginally significant effects (0.51-0.66 kg) were found in arm D (1, 6, 9, and 12 mo); in arm E, marginally significant effects (0.48-0.75 kg) were found from 6 to 24 mo.
","['Guatemala on maternal weight from pregnancy to 24 mo postpartum', 'Guatemala', '3535 women were analyzed']","['individual maternal ration type [corn-soy blend (CSB), lipid-based nutrient supplement (LNS), micronutrient powder (MNP', 'FA-MCHN program', 'Food-assisted maternal and child health and nutrition (FA-MCHN']","['Weight', 'family ration size [full (FFR), reduced (RFR), none (NFR']","[{'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1264664', 'cui_str': 'Number fraction'}]",3535.0,0.100416,"Marginally significant effects (0.51-0.66 kg) were found in arm D (1, 6, 9, and 12 mo); in arm E, marginally significant effects (0.48-0.75 kg) were found from 6 to 24 mo.
","[{'ForeName': 'Jef L', 'Initials': 'JL', 'LastName': 'Leroy', 'Affiliation': 'Poverty, Health and Nutrition, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Deanna K', 'Initials': 'DK', 'LastName': 'Olney', 'Affiliation': 'Poverty, Health and Nutrition, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Ruel', 'Affiliation': 'Poverty, Health and Nutrition, International Food Policy Research Institute, Washington, DC, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz175']
739,31623764,Guiding Therapy by Coronary CT Angiography Improves Outcomes in Patients With Stable Chest Pain.,"BACKGROUND


Within the SCOT-HEART (Scottish COmputed Tomography of the HEART Trial) trial of patients with stable chest pain, the use of coronary computed tomography angiography (CTA) reduced the rate of death from coronary heart disease or nonfatal myocardial infarction (primary endpoint).
OBJECTIVES


This study sought to assess the consistency and mechanisms of the 5-year reduction in this endpoint.
METHODS


In this open-label trial, 4,146 participants were randomized to standard care alone or standard care plus coronary CTA. This study explored the primary endpoint by symptoms, diagnosis, coronary revascularizations, and preventative therapies.
RESULTS


Event reductions were consistent across symptom and risk categories (p = NS for interactions). In patients who were not diagnosed with angina due to coronary heart disease, coronary CTA was associated with a lower primary endpoint incidence rate (0.23; 95% confidence interval [CI]: 0.13 to 0.35 vs. 0.59; 95% CI: 0.42 to 0.80 per 100 patient-years; p < 0.001). In those who had undergone coronary CTA, rates of coronary revascularization were higher in the first year (hazard ratio [HR]: 1.21; 95% CI: 1.01 to 1.46; p = 0.042) but lower beyond 1 year (HR: 0.59; 95% CI: 0.38 to 0.90; p = 0.015). Patients assigned to coronary CTA had higher rates of preventative therapies throughout follow-up (p < 0.001 for all), with rates highest in those with CT-defined coronary artery disease. Modeling studies demonstrated the plausibility of the observed effect size.
CONCLUSIONS


The beneficial effect of coronary CTA on outcomes is consistent across subgroups with plausible underlying mechanisms. Coronary CTA improves coronary heart disease outcomes by enabling better targeting of preventative treatments to those with coronary artery disease. (Scottish COmputed Tomography of the HEART Trial [SCOT-HEART]; NCT01149590).",2019,"Patients assigned to coronary CTA had higher rates of preventative therapies throughout follow-up (p < 0.001 for all), with rates highest in those with CT-defined coronary artery disease.","['Patients', 'patients with stable chest pain', '4,146 participants']","['Coronary CTA', 'coronary computed tomography angiography (CTA', 'coronary CTA', 'Coronary CT Angiography', 'standard care alone or standard care plus coronary CTA']","['symptoms, diagnosis, coronary revascularizations, and preventative therapies', 'rates of coronary revascularization', 'coronary heart disease outcomes', 'rates of preventative therapies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]",4146.0,0.163119,"Patients assigned to coronary CTA had higher rates of preventative therapies throughout follow-up (p < 0.001 for all), with rates highest in those with CT-defined coronary artery disease.","[{'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Christchurch Heart Institute, University of Otago, Christchurch, New Zealand. Electronic address: philip.adamson@cdhb.health.nz.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Boon', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Daghem', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Timmis', 'Affiliation': 'William Harvey Research Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': ""Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Ahmadi', 'Affiliation': ""Ichan School of Medicine and Mount Sinai Hospital, Mount Sinai Heart, New York, New York; St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Leipsic', 'Affiliation': ""St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jagat', 'Initials': 'J', 'LastName': 'Narula', 'Affiliation': 'Ichan School of Medicine and Mount Sinai Hospital, Mount Sinai Heart, New York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.085']
740,31562798,Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.,"BACKGROUND


Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established.
METHODS


We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction.
RESULTS


At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0).
CONCLUSIONS


In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).",2019,"Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1).","['patients with left main coronary artery disease', 'group, 957 patients', '1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either']","['PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG', 'coronary-artery bypass grafting (CABG', 'CABG', 'PCI or CABG', 'percutaneous coronary intervention (PCI) with contemporary drug-eluting stents']","['All cerebrovascular events', 'composite of death, stroke, or myocardial infarction', 'Ischemia-driven revascularization', 'death, stroke, or myocardial infarction', 'myocardial infarction', 'incidences of definite cardiovascular death', 'Death', 'incidence of stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0303986', 'cui_str': 'Fluoropolymer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}]",1905.0,0.392253,"Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1).","[{'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Puskas', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Karmpaliotis', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'W Morris', 'Initials': 'WM', 'LastName': 'Brown', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Lembo', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Banning', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Horkay', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Piet W', 'Initials': 'PW', 'LastName': 'Boonstra', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Ad J', 'Initials': 'AJ', 'LastName': 'van Boven', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Bogáts', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Mansour', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pomar', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hickey', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gershlick', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Pawel E', 'Initials': 'PE', 'LastName': 'Buszman', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Bochenek', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Schampaert', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Pagé', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Simonton', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ""From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1909406']
741,31779689,Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial.,"BACKGROUND


Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking.
METHODS/DESIGN


This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme.
DISCUSSION


This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI.
TRIAL REGISTRATION


ISRCTN registry, ISRCTN59404712. Registered 28/11/17.",2019,"This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI.
","['Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking', 'Eligible participants', 'hardcore smokers with smoking-related chronic disease', 'smokers with smoking-related chronic diseases or SMI', 'smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking']","['general practitioner and nurse promotion of electronic cigarettes versus standard care', 'general practitioners (GPs) and nurses delivering a brief advice intervention', 'control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials']","['patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention', 'smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months', 'smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence', 'feasibility, acceptability and effectiveness']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4505216', 'cui_str': 'Vaper'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0726383,"This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI.
","[{'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK. rachna.begh@phc.ox.ac.uk.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Coleman', 'Affiliation': ""Division of Primary Care, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Academic Unit of Psychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Barnes', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, NR4 7UL, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Gilbert', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ferrey', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Madigan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Hamilton', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Warren', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Grabey', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Clark', 'Affiliation': ""Division of Primary Care, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dickinson', 'Affiliation': ""Division of Primary Care, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}]",Trials,['10.1186/s13063-019-3850-1']
742,30932508,Positive impact of IPS supported employment on PTSD-related occupational-psychosocial functional outcomes: Results from a VA randomized-controlled trial.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) has significant negative effects on occupational, interpersonal, and social functioning. Supported employment is highly effective in helping people with a diagnosis of PTSD obtain and maintain competitive employment. However, less is known about the impact of supported employment on functioning in work or school, social, and interpersonal areas as specifically related to the symptoms of PTSD.
METHOD


The Veterans Individual Placement and Support Toward Advancing Recovery study was a prospective, multisite, randomized, controlled trial that compared Individual Placement and Support (IPS) supported employment with a stepwise vocational rehabilitation involving transitional work (TW) assignments with unemployed veterans with PTSD diagnoses (n = 541) at 12 Veterans Administration (VA) medical centers. This analysis focuses on the PTSD-related functional outcomes over the 18-month follow-up period.
RESULTS


Compared with those randomized to TW, the PTSD Related Functioning Inventory (PRFI) total score significantly improved for participants randomized to IPS (LSMeans difference = -3.92, 95% CI [-7.49, -.36]; p = .03) over 18 months. When the Work/School subscale of the PRFI was removed from the analysis, the IPS group continued to show significant improvements compared with the TW group on the PRFI relationship and lifestyle domains (LSMeans difference = -2.37, 95% CI [-4.74, .00]; p = .05), suggesting a positive impact of IPS beyond work/school functioning.
CONCLUSION


Compared with the usual-care VA vocational services for veterans with PTSD, IPS supported employment is associated with greater improvement in overall PTSD-related functioning, including occupational, interpersonal, and lifestyle domains. In addition to superior employment outcomes, IPS has a positive impact on occupational-psychosocial functioning outcomes. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Compared with those randomized to TW, the PTSD Related Functioning Inventory (PRFI) total score significantly improved for participants randomized to IPS (LSMeans difference = -3.92, 95% CI [-7.49, -.36]","['unemployed veterans with PTSD diagnoses (n = 541) at 12 Veterans Administration (VA) medical centers', 'Posttraumatic stress disorder (PTSD']",['Individual Placement and Support (IPS) supported employment with a stepwise vocational rehabilitation involving transitional work (TW) assignments'],"['PRFI relationship and lifestyle domains', 'PTSD Related Functioning Inventory (PRFI) total score', 'positive impact of IPS beyond work/school functioning', 'overall PTSD-related functioning, including occupational, interpersonal, and lifestyle domains']","[{'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0041735', 'cui_str': 'United States. Dept. of Veterans Affairs'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0085362', 'cui_str': 'Employment, Supported'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation (regime/therapy)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}]",,0.0560995,"Compared with those randomized to TW, the PTSD Related Functioning Inventory (PRFI) total score significantly improved for participants randomized to IPS (LSMeans difference = -3.92, 95% CI [-7.49, -.36]","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mueller', 'Affiliation': 'Department of Psychology, Edith Nourse Rogers Memorial Veterans Hospital.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Wolfe', 'Affiliation': 'San Francisco Veterans Affairs Medical Center.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'San Francisco Veterans Affairs Medical Center.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'McCaslin', 'Affiliation': 'Dissemination & Training Division, National Center for PTSD.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yehuda', 'Affiliation': 'James J. Peters Veterans Affairs Medical Center.'}, {'ForeName': 'Janine D', 'Initials': 'JD', 'LastName': 'Flory', 'Affiliation': 'James J. Peters Veterans Affairs Medical Center.'}, {'ForeName': 'Tassos C', 'Initials': 'TC', 'LastName': 'Kyriakides', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Veterans Affairs Connecticut Healthcare System.'}, {'ForeName': 'Rich', 'Initials': 'R', 'LastName': 'Toscano', 'Affiliation': 'Tuscaloosa Veterans Affairs Medical Center.'}, {'ForeName': 'Lori L', 'Initials': 'LL', 'LastName': 'Davis', 'Affiliation': 'Tuscaloosa Veterans Affairs Medical Center.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000345']
743,30777112,Community perspectives on treating asymptomatic infections for malaria elimination in The Gambia.,"BACKGROUND


Innovative and cost-effective strategies that clear asymptomatic malaria infections are required to reach malaria elimination goals, but remain a challenge. This mixed methods study explored people's attitudes towards the reactive treatment of compound contacts of malaria cases with a 3-day course of dihydroartemisinin-piperaquine (DHAP), the socio-cultural representations of asymptomatic infections, and more specifically their treatment.
METHODS


Prior to the start of the intervention, a sequential mixed method study was carried out. Qualitative data collection involved in-depth interviews and participant observations (including informal conversations) with key informants from the trial communities and the trial staff. Quantitative data were derived from a pre-trial cross-sectional survey on health literacy and health-seeking behaviour among randomly selected members of the study communities.
RESULTS


In the pre-trial cross-sectional survey, 73% of respondents reported that malaria could be hidden in the body without symptoms. Whilst this may be interpreted as people's comprehension of asymptomatic malaria, qualitative data indicated that informants had different interpretations of asymptomatic disease than the biomedical model. It was described as: (i) a minor illness that does not prevent people carrying out daily activities; (ii) an illness that oscillates between symptomatic and asymptomatic phases; and, (iii) a condition where disease agents are present in the body but remain hidden, without signs and symptoms, until something triggers their manifestation. Furthermore, this form of hidden malaria was reported to be most present in those living in the same compound with a malaria case (71%).
CONCLUSION


Treating asymptomatic malaria with pharmaceuticals was considered acceptable. However, people felt uncertain to take treatment without screening for malaria first, largely due to the lack of symptoms. Knowledge of asymptomatic malaria was not a strong re-inforcement for treatment adherence. In this study, the pre-intervention active engagement of communities existed of having people co-design accurate information messages about their personal risk of malaria, which increased their trust in expert knowledge and thus proved essential for the successful implementation of the community-based intervention.",2019,Knowledge of asymptomatic malaria was not a strong re-inforcement for treatment adherence.,['randomly selected members of the study communities'],['dihydroartemisinin-piperaquine (DHAP'],[],"[{'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}]",[],,0.037169,Knowledge of asymptomatic malaria was not a strong re-inforcement for treatment adherence.,"[{'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Jaiteh', 'Affiliation': 'Medical Anthropology Unit, Institute of Tropical Medicine, Antwerp, Belgium. fjaiteh@mrc.gm.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Masunaga', 'Affiliation': 'Medical Anthropology Unit, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Okebe', 'Affiliation': 'Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Balen', 'Affiliation': 'School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gryseels', 'Affiliation': 'Medical Anthropology Unit, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Joan Muela', 'Initials': 'JM', 'LastName': 'Ribera', 'Affiliation': 'PASS Suisse, Neuchâtel, Switzerland.'}, {'ForeName': 'Koen Peeters', 'Initials': 'KP', 'LastName': 'Grietens', 'Affiliation': 'Medical Anthropology Unit, Institute of Tropical Medicine, Antwerp, Belgium.'}]",Malaria journal,['10.1186/s12936-019-2672-7']
744,30865791,A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis.,"BACKGROUND


Cohort studies in Bangladesh showed promising cure rates among patients with multidrug-resistant tuberculosis who received existing drugs in regimens shorter than that recommended by the World Health Organization (WHO) in 2011.
METHODS


We conducted a phase 3 noninferiority trial in participants with rifampin-resistant tuberculosis that was susceptible to fluoroquinolones and aminoglycosides. Participants were randomly assigned, in a 2:1 ratio, to receive a short regimen (9 to 11 months) that included high-dose moxifloxacin or a long regimen (20 months) that followed the 2011 WHO guidelines. The primary efficacy outcome was a favorable status at 132 weeks, defined by cultures negative for  Mycobacterium tuberculosis  at 132 weeks and at a previous occasion, with no intervening positive culture or previous unfavorable outcome. An upper 95% confidence limit for the between-group difference in favorable status that was 10 percentage points or less was used to determine noninferiority.
RESULTS


Of 424 participants who underwent randomization, 383 were included in the modified intention-to-treat population. Favorable status was reported in 79.8% of participants in the long-regimen group and in 78.8% of those in the short-regimen group - a difference, with adjustment for human immunodeficiency virus status, of 1.0 percentage point (95% confidence interval [CI], -7.5 to 9.5) (P = 0.02 for noninferiority). The results with respect to noninferiority were consistent among the 321 participants in the per-protocol population (adjusted difference, -0.7 percentage points; 95% CI, -10.5 to 9.1). An adverse event of grade 3 or higher occurred in 45.4% of participants in the long-regimen group and in 48.2% in the short-regimen group. Prolongation of either the QT interval or the corrected QT interval (calculated with Fridericia's formula) to 500 msec occurred in 11.0% of participants in the short-regimen group, as compared with 6.4% in the long-regimen group (P = 0.14); because of the greater incidence in the short-regimen group, participants were closely monitored and some received medication adjustments. Death occurred in 8.5% of participants in the short-regimen group and in 6.4% in the long-regimen group, and acquired resistance to fluoroquinolones or aminoglycosides occurred in 3.3% and 2.3%, respectively.
CONCLUSIONS


In persons with rifampin-resistant tuberculosis that was susceptible to fluoroquinolones and aminoglycosides, a short regimen was noninferior to a long regimen with respect to the primary efficacy outcome and was similar to the long regimen in terms of safety. (Funded by the U.S. Agency for International Development and others; Current Controlled Trials number, ISRCTN78372190; ClinicalTrials.gov number, NCT02409290.).",2019,An adverse event of grade 3 or higher occurred in 45.4% of participants in the long-regimen group and in 48.2% in the short-regimen group.,"['persons with rifampin-resistant tuberculosis', 'patients with multidrug-resistant tuberculosis who received existing drugs in regimens shorter than that recommended by the World Health Organization (WHO) in 2011', 'participants with rifampin-resistant tuberculosis that was susceptible to fluoroquinolones and aminoglycosides', 'Rifampin-Resistant Tuberculosis', '424 participants who underwent randomization, 383 were included in the modified intention-to-treat population']","['moxifloxacin', 'fluoroquinolones and aminoglycosides']","['Death', 'corrected QT interval', 'Favorable status', 'acquired resistance to fluoroquinolones or aminoglycosides']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206526', 'cui_str': 'Tuberculosis, Multi-Drug Resistant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}]",,0.277203,An adverse event of grade 3 or higher occurred in 45.4% of participants in the long-regimen group and in 48.2% in the short-regimen group.,"[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Nunn', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Patrick P J', 'Initials': 'PPJ', 'LastName': 'Phillips', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Meredith', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Chen-Yuan', 'Initials': 'CY', 'LastName': 'Chiang', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Conradie', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Doljinsuren', 'Initials': 'D', 'LastName': 'Dalai', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'van Deun', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Phan-Thuong', 'Initials': 'PT', 'LastName': 'Dat', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Ngoc', 'Initials': 'N', 'LastName': 'Lan', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Master', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Tesfamarium', 'Initials': 'T', 'LastName': 'Mebrahtu', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Meressa', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Ronelle', 'Initials': 'R', 'LastName': 'Moodliar', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Nosipho', 'Initials': 'N', 'LastName': 'Ngubane', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sanders', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Stephen Bertel', 'Initials': 'SB', 'LastName': 'Squire', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Torrea', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'Bazarragchaa', 'Initials': 'B', 'LastName': 'Tsogt', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Rusen', 'Affiliation': ""From the Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London (A.J.N, P.P.J.P., S.K.M., K.S.), and the Liverpool School of Tropical Medicine, Liverpool (S.B.S.) - both in the United Kingdom; International Union against Tuberculosis and Lung Disease (the Union), Paris (C.-Y.C., A.D., I.D.R.); the Department of Internal Medicine, Wanfang Hospital, and School of Medicine, Taipei Medical University (C.-Y.C.) - both in Taipei, Taiwan; the University of Witwatersrand, Faculty of Health Sciences, Johannesburg (F.C.), King Dinizulu Hospital Complex, Kwazulu Natal (I.M., N.N.), and Think TB and HIV Investigative Network, Durban (R.M.) - all in South Africa; National Center for Communicable Diseases (D.D.) and the Mongolian Tuberculosis Coalition (B.T.) - both in Ulaanbaatar, Mongolia; the Institute of Tropical Medicine, Antwerp, Belgium (A.D., G.T.); Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam (P.-T.D., N.L.); Armauer Hansen Research Institute (T.M.), and St. Peter's Tuberculosis Specialized Hospital and Global Health Committee (D.M.) - all in Addis Ababa, Ethiopia; the Division of Research and Development, Vital Strategies, New York (I.D.R.); and the Dalla Lana School of Public Health, University of Toronto, Toronto (I.D.R.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1811867']
745,31043522,A randomized placebo-controlled pilot trial shows that intranasal vasopressin improves social deficits in children with autism.,"The social impairments of autism spectrum disorder (ASD) have a major impact on quality of life, yet there are no medications that effectively treat these core social behavior deficits. Preclinical research suggests that arginine vasopressin (AVP), a neuropeptide involved in promoting mammalian social behaviors, may be a possible treatment for ASD. Using a double-blind, randomized, placebo-controlled, parallel study design, we tested the efficacy and tolerability of a 4-week intranasal AVP daily treatment in 30 children with ASD. AVP-treated participants aged 6 to 9.5 years received the maximum daily target dose of 24 International Units (IU); participants aged 9.6 to 12.9 years received the maximum daily target dose of 32 IU. Intranasal AVP treatment compared to placebo enhanced social abilities as assessed by change from baseline in this phase 2 trial's primary outcome measure, the Social Responsiveness Scale, 2nd Edition total score (SRS-2  T  score;  F   1,20  = 9.853;  P  = 0.0052; η p   2  = 33.0%; Cohen's  d  = 1.40). AVP treatment also diminished anxiety symptoms and some repetitive behaviors. Most of these findings were more pronounced when we accounted for pretreatment AVP concentrations in blood. AVP was well tolerated with minimal side effects. No AVP-treated participants dropped out of the trial, and there were no differences in the rate of adverse events reported between treatment conditions. Last, no changes from baseline were observed in vital signs, electrocardiogram tracings, height and body weight, or clinical chemistry measurements after 4 weeks of AVP treatment. These preliminary findings suggest that AVP has potential for treating social impairments in children with ASD.",2019,"No AVP-treated participants dropped out of the trial, and there were no differences in the rate of adverse events reported between treatment conditions.","['children with ASD', 'children with autism', 'AVP-treated participants aged 6 to 9.5 years received the maximum daily target dose of 24 International Units (IU); participants aged 9.6 to 12.9 years', 'autism spectrum disorder (ASD', '30 children with ASD']","['intranasal AVP', 'arginine vasopressin (AVP', 'AVP', 'intranasal vasopressin', 'placebo', 'Intranasal AVP']","['anxiety symptoms and some repetitive behaviors', 'vital signs, electrocardiogram tracings, height and body weight, or clinical chemistry measurements', 'social abilities', 'social deficits', 'Social Responsiveness Scale, 2nd Edition total score', 'efficacy and tolerability', 'rate of adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0008000', 'cui_str': 'Chemistry, Clinical'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0222045'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.467857,"No AVP-treated participants dropped out of the trial, and there were no differences in the rate of adverse events reported between treatment conditions.","[{'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA. kjparker@stanford.edu.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Oztan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Libove', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Mohsin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Karhson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Raena D', 'Initials': 'RD', 'LastName': 'Sumiyoshi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Jacqueline E', 'Initials': 'JE', 'LastName': 'Summers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Kyle E', 'Initials': 'KE', 'LastName': 'Hinman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Motonaga', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Dean S', 'Initials': 'DS', 'LastName': 'Carson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Lawrence K', 'Initials': 'LK', 'LastName': 'Fung', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Garner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Antonio Y', 'Initials': 'AY', 'LastName': 'Hardan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}]",Science translational medicine,['10.1126/scitranslmed.aau7356']
746,31014344,Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme).,"BACKGROUND


MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention.
METHODS


An expert panel, consisting of the MACRO Programme Management Group, independent advisors, and patient contributors, was convened to review current evidence and the mixed-method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of orally administered steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design.
RESULTS


A 12-week course of clarithromycin was agreed as the main trial comparator due to its increasing use as a first- and second-line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Orally administered steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure that the MACRO trial is both pragmatic and generalisable to primary care. A modified, three-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that the patients recruited would be considered eligible for the treatment offered in the trial due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation.
CONCLUSION


The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS.",2019,"An expert panel, consisting of the MACRO Programme Management Group, independent advisors, and patient contributors, was convened to review current evidence and the mixed-method data collected as part of the programme, and reach agreement on MACRO trial design.","['Adults with Chronic RhinOsinusitis', 'patients with CRS', 'adults with chronic rhinosinusitis (CRS', 'Inclusion criteria were amended to ensure that the patients recruited would be considered eligible for the treatment offered in the trial due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon']","['macrolide antibiotics and endoscopic sinus surgery', 'clarithromycin']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0586894', 'cui_str': 'Ear, nose and throat surgeon (occupation)'}]","[{'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]",[],,0.108797,"An expert panel, consisting of the MACRO Programme Management Group, independent advisors, and patient contributors, was convened to review current evidence and the mixed-method data collected as part of the programme, and reach agreement on MACRO trial design.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Blackshaw', 'Affiliation': 'evidENT, Ear Institute, University College London, London, UK. H.blackshaw@ucl.ac.uk.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Vennik', 'Affiliation': 'Primary Care and Populations Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Philpott', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Populations Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Eyles', 'Affiliation': 'Primary Care and Populations Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carpenter', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Clarke', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schilder', 'Affiliation': 'evidENT, Ear Institute, University College London, London, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Lund', 'Affiliation': 'evidENT, Ear Institute, University College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'James Paget University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Durham', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Spiros', 'Initials': 'S', 'LastName': 'Denaxas', 'Affiliation': 'Farr Institute, University College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Farr Institute, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beard', 'Affiliation': 'Surgical Interventional Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Surgical Interventional Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Le Conte', 'Affiliation': 'Surgical Interventional Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Airey', 'Affiliation': 'evidENT, Ear Institute, University College London, London, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Boardman', 'Affiliation': 'Fifth Sense, Sanderum House, 38 Oakley Road, Chinnor, Oxfordshire, OX39 4TW, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hopkins', 'Affiliation': ""Guy's and St. Thomas' NHS Foundation Trust, London, UK.""}]",Trials,['10.1186/s13063-019-3318-3']
747,30836166,"Dose Escalation for Prostate Adenocarcinoma: A Long-Term Update on the Outcomes of a Phase 3, Single Institution Randomized Clinical Trial.","PURPOSE


To determine the long-term outcomes for prostate adenocarcinoma when escalating radiation dose from 70 Gy to 78 Gy.
METHODS AND MATERIALS


Between 1993 and 1998, 301 patients with biopsy-proven clinical stage T1b-T3 prostate adenocarcinoma, any prostate-specific antigen level, and any Gleason score were randomized to 70 Gy in 35 fractions versus 78 Gy in 39 fractions of photon radiation therapy using a 4-field box technique without hormone deprivation therapy. The primary outcome was powered to detect a 15% difference in biochemical or clinical failure. Secondary outcomes included survival, prostate cancer mortality, biochemical failure, local failure, nodal failure, distant failure, and secondary malignancy rates.
RESULTS


With a median follow-up of 14.3 years, the cumulative incidence of 15-year biochemical or clinical failure was 18.9% versus 12.0% in the 70 Gy versus 78 Gy arms, respectively (subhazard ratio [sHR], 0.61; 95% confidence interval [CI], 0.38-0.98; Fine-Gray P = .042). The 15-year cumulative incidence of distant metastasis was 3.4% versus 1.1%, respectively (sHR, 0.33; 95% CI, 0.13-0.82; Fine-Gray P = .018). The 15-year cumulative incidence of prostate cancer-specific mortality was 6.2% versus 3.2%, respectively, (sHR, 0.52; 95% CI, 0.27-0.98; Fine-Gray P = .045). There were no differences in overall survival (HR, 1.10; 95% CI, 0.84-1.45; log rank P = .469) or other-cause survival (sHR, 1.33; 95% CI, 0.99-1.79; Fine-Gray P = .061). Salvage therapy was more common in the 70 Gy arm, at 38.7% versus 21.9% in the 78 Gy arm (P = .002). There was a 2.3% secondary solid malignancy rate (1 bladder, 6 rectal) within the radiation treatment field, which was not significantly different between treatment arms.
CONCLUSIONS


Dose escalation by 8 Gy (78 Gy vs 70 Gy) provided a sustained improvement in biochemical and clinical failure, which translated into lower salvage rates and improved prostate cancer-specific mortality, but not overall survival. Long-term follow-up demonstrated a low incidence of potential solid tumor secondary malignancies.",2019,"CONCLUSIONS


Dose escalation by 8 Gy (78 Gy vs 70 Gy) provided a sustained improvement in biochemical and clinical failure, which translated into lower salvage rates and improved prostate cancer-specific mortality, but not overall survival.","['Prostate Adenocarcinoma', 'Between 1993 and 1998, 301 patients with biopsy-proven clinical stage T1b-T3 prostate adenocarcinoma, any prostate-specific antigen level, and any Gleason score', 'With a median follow-up of 14.3\xa0years']",['70\xa0Gy in 35 fractions versus 78\xa0Gy in 39 fractions of photon radiation therapy using a 4-field box technique without hormone deprivation therapy'],"['survival, prostate cancer mortality, biochemical failure, local failure, nodal failure, distant failure, and secondary malignancy rates', '15-year cumulative incidence of distant metastasis', 'biochemical or clinical failure', '15-year cumulative incidence of prostate cancer-specific mortality', 'biochemical and clinical failure', 'solid malignancy rate', 'salvage rates and improved prostate cancer-specific mortality', 'cumulative incidence of 15-year biochemical or clinical failure', 'overall survival']","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0854652', 'cui_str': 'Photon radiation therapy'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",301.0,0.415313,"CONCLUSIONS


Dose escalation by 8 Gy (78 Gy vs 70 Gy) provided a sustained improvement in biochemical and clinical failure, which translated into lower salvage rates and improved prostate cancer-specific mortality, but not overall survival.","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Pasalic', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kuban', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Pamela K', 'Initials': 'PK', 'LastName': 'Allen', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Shane M', 'Initials': 'SM', 'LastName': 'Mesko', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Grant', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Augustyn', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Frank', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Seungtaek', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Hoffman', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Quynh-Nhu', 'Initials': 'QN', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'McGuire', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Department of Radiation Oncology, The University of Miami, Miami, Florida.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Anscher', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: msanscher@mdanderson.org.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2019.02.045']
748,32072792,"Effects of lumbar stabilization and muscular stretching on pain, disabilities, postural control and muscle activation in pregnant woman with low back pain.","BACKGROUND


Low back pain is common during pregnancy. Lumbar stabilization and stretching exercises are recommended to treat low back pain in the general population. However, few studies have applied the effects of these two interventions in pregnant women with low back pain.
AIM


To compare the effects of lumbar stabilization and stretching exercises for the treatment of gestational low back pain.
DESIGN


A pilot randomized clinical trial.
SETTING


Laboratory of Functional Evaluation and Human Motor Performance and physical therapy clinics.
POPULATION


Initially, 30 pregnant women with low back pain were recruited, of which 24 met the following inclusion criteria: being between 19-29 weeks of gestation; being in prenatal clinical follow-up; having nonspecific mechanical low back pain started in pregnancy; not participating in specific low back pain treatment in the last 3 months. A total of 20 women completed the study (10 each group).
METHODS


The main outcome measures were clinical (pain by Visual Analogue Scale (VAS) and McGill Pain Questionnaire and disability by Roland Morris Questionnaire), and secondary outcome measures were: postural balance (force platform); muscle activation level of multifidus, iliocostalis lumborum, rectus abdominis and external abdominal oblique (electromyography). The women were randomized into two groups for 6 weeks of intervention twice a week for a 50-minute treatment: 1) lumbar stabilization exercise protocol and 2) stretching exercise protocol.
RESULTS


There was a significant reduction (P=0.03) in pain (1.68 in VAS and 4.81 for McGill questionnaire) for both interventions, but no change in disability score. In addition, both interventions were comparable for a significant improvement in postural stability (in mean d=0.77) for the velocity sway parameter, and significantly increased activation (P>0.05) of the external abdominal oblique muscle after intervention.
CONCLUSIONS


Both modalities (lumbar stabilization and stretching) were efficient for pain reduction, improving balance and increasing one trunk activity muscle after 6 weeks of intervention in pregnant women with low back pain.
CLINICAL REHABILITATION IMPACT


The present study has implications, especially for clinical decision-making with regard to therapy choice in pregnant women with LBP to reduce pain and improve trunk function as measured through balance performance.",2020,"There was a significant reduction (p = 0.03) in pain (1.68 in VAS and 4.81 for McGill questionnaire) for both interventions, but no change in disability score.","['pregnant woman with low back pain', '20 women completed the study (10 each group', 'pregnant women with low back pain', 'Initially, 30 pregnant women with low back pain were recruited, of which 24 met the following inclusion criteria: being between 19-29 weeks of gestation; being in prenatal clinical follow-up; having nonspecific mechanical low back pain started in pregnancy; not participating in specific low back pain treatment in the last 3 months', 'pregnant women with LBP', 'gestational low back pain']","['lumbar stabilization exercise protocol and 2) stretching exercise protocol', 'lumbar stabilization and muscular stretching', 'lumbar stabilization and stretching exercises', 'Lumbar stabilization and stretching exercises']","['disability score', 'clinical (pain by Visual Analogue Scale (VAS) and McGill Pain Questionnaire and disability by Roland Morris Questionnaire), and secondary outcome measures were: postural balance (force platform); muscle activation level of multifidus, iliocostalis lumborum, rectus abdominis and external abdominal oblique (electromyography', 'postural stability', 'activation', 'pain, disabilities, postural control and muscle activation', 'pain', 'pain reduction, improving balance and increasing one trunk activity muscle']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0423682', 'cui_str': 'Low Back Pain, Mechanical'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0224319', 'cui_str': 'Multifidus'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4508995', 'cui_str': 'Improved balance'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",30.0,0.127456,"There was a significant reduction (p = 0.03) in pain (1.68 in VAS and 4.81 for McGill questionnaire) for both interventions, but no change in disability score.","[{'ForeName': 'Adriana P', 'Initials': 'AP', 'LastName': 'Fontana Carvalho', 'Affiliation': 'Laboratory of Functional Evaluation and Human Motor Performance (LAFUP), Universidade Pitagoras UNOPAR, Londrina, PR, Brazil.'}, {'ForeName': 'Sébastien S', 'Initials': 'SS', 'LastName': 'Dufresne', 'Affiliation': 'Department of Health Sciences, BioNR Research Laboratory, Université du Québec à Chicoutimi, Chicoutimi QC, Canada.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Rogerio de Oliveira', 'Affiliation': 'Laboratory of Functional Evaluation and Human Motor Performance (LAFUP), Universidade Pitagoras UNOPAR, Londrina, PR, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Couto Furlanetto', 'Affiliation': 'Laboratory of Functional Evaluation and Human Motor Performance (LAFUP), Universidade Pitagoras UNOPAR, Londrina, PR, Brazil.'}, {'ForeName': 'Maryane', 'Initials': 'M', 'LastName': 'Dubois', 'Affiliation': 'Department of Health Sciences, BioNR Research Laboratory, Université du Québec à Chicoutimi, Chicoutimi QC, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Dallaire', 'Affiliation': 'Department of Health Sciences, BioNR Research Laboratory, Université du Québec à Chicoutimi, Chicoutimi QC, Canada.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Ngomo', 'Affiliation': 'Department of Health Sciences, BioNR Research Laboratory, Université du Québec à Chicoutimi, Chicoutimi QC, Canada.'}, {'ForeName': 'Rubens A', 'Initials': 'RA', 'LastName': 'da Silva', 'Affiliation': 'Laboratory of Functional Evaluation and Human Motor Performance (LAFUP), Universidade Pitagoras UNOPAR, Londrina, PR, Brazil - rubens.dasilva@uqac.ca.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06086-4']
749,30916641,Sexual risk reduction interventions for patients attending sexual health clinics: a mixed-methods feasibility study.,"BACKGROUND


Sexually transmitted infections (STIs) continue to represent a major public health challenge. There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services. However, it is not known if these interventions are effective when implemented at scale in SH settings in England.
OBJECTIVES


The study (Santé) had two main objectives - (1) to develop and pilot a package of evidence-based sexual risk reduction interventions that can be delivered through SH services and (2) to assess the feasibility of conducting a randomised controlled trial (RCT) to determine effectiveness against usual care.
DESIGN


The project was a multistage, mixed-methods study, with developmental and pilot RCT phases. Preparatory work included a systematic review, an analysis of national surveillance data, the development of a triage algorithm, and interviews and surveys with SH staff and patients to identify, select and adapt interventions. A pilot cluster RCT was planned for eight SH clinics; the intervention would be offered in four clinics, with qualitative and process evaluation to assess feasibility and acceptability. Four clinics acted as controls; in all clinics, participants would be consented to a 6-week follow-up STI screen.
SETTING


SH clinics in England.
PARTICIPANTS


Young people (aged 16-25 years), and men who have sex with men.
INTERVENTION


A three-part intervention package - (1) a triage tool to score patients as being at high or low risk of STI using routine data, (2) a study-designed web page with tailored SH information for all patients, regardless of risk and (3) a brief one-to-one session based on motivational interviewing for high-risk patients.
MAIN OUTCOME MEASURES


The three outcomes were (1) the acceptability of the intervention to patients and SH providers, (2) the feasibility of delivering the interventions within existing resources and (3) the feasibility of obtaining follow-up data on STI diagnoses (primary outcome in a full trial).
RESULTS


We identified 33 relevant trials from the systematic review, including videos, peer support, digital and brief one-to-one sessions. Patients and SH providers showed preferences for one-to-one and digital interventions, and providers indicated that these intervention types could feasibly be implemented in their settings. There were no appropriate digital interventions that could be adapted in time for the pilot; therefore, we created a placeholder for the purposes of the pilot. The intervention package was piloted in two SH settings, rather than the planned four. Several barriers were found to intervention implementation, including a lack of trained staff time and clinic space. The intervention package was theoretically acceptable, but we observed poor engagement. We recruited patients from six clinics for the follow-up, rather than eight. The completion rate for follow-up was lower than anticipated (16% vs. 46%).
LIMITATIONS


Fewer clinics were included in the pilot than planned, limiting the ability to make strong conclusions on the feasibility of the RCT.
CONCLUSION


We were unable to conclude whether or not a definitive RCT would be feasible because of challenges in implementation of a pilot, but have laid the groundwork for future research in the area.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN16738765.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 12. See the NIHR Journals Library website for further project information.",2019,There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services.,"['Young people (aged 16-25 years), and men who have sex with men', 'patients attending sexual health clinics', 'SH clinics in England', 'patients attending sexual health (SH) services', 'recruited patients from six clinics for the follow-up, rather than eight']","['brief one-to-one session based on motivational interviewing', 'Sexual risk reduction interventions']","['STI rates', 'risky sexual behaviours', 'completion rate']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0603458,There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Burns', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Howarth', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Gwenda', 'Initials': 'G', 'LastName': 'Hughes', 'Affiliation': 'Sexually Transmitted Infection Surveillance, Public Health England, London, UK.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Miners', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pollard', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23120']
750,30739747,"Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial.","BACKGROUND


Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage.
METHODS


MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1·0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0-3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046.
FINDINGS


Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0-3 at 365 days (adjusted risk difference 4% [95% CI -4 to 12]; p=0·33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0·60 (p=0·03), 0·84 (p=0·42), 0·87 (p=0·49), and 0·82 (p=0·44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0·02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0·07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0·012).
INTERPRETATION


For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons.
FUNDING


National Institute of Neurological Disorders and Stroke and Genentech.",2019,The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections).,"['499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set', 'patients with intracerebral haemorrhage', '78 hospitals in the USA, Canada, Europe, Australia, and Asia', 'Between Dec 30, 2013, and Aug 15, 2017, 506 patients', 'intracerebral haemorrhage evacuation (MISTIE III', 'enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more']","['minimally invasive catheter evacuation followed by thrombolysis (MISTIE', 'standard medical care', 'minimally invasive surgery with thrombolysis']","['serious adverse event', 'number of serious adverse events', 'good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score', 'symptomatic bleeding', 'prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location', 'number of patients with symptomatic bleeding and brain bacterial infections', 'Efficacy and safety', 'mRS score', 'modified intention-to-treat (mITT) population']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4324376', 'cui_str': 'Symptomatic bleeding'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",506.0,0.164633,The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections).,"[{'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA. Electronic address: dhanley@jhmi.edu.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rosenblum', 'Affiliation': 'Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Mayo', 'Affiliation': 'Emissary International, Austin, TX, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Bistran-Hall', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Gandhi', 'Affiliation': 'University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'W Andrew', 'Initials': 'WA', 'LastName': 'Mould', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ullman', 'Affiliation': ""The Children's Hospital, Philadelphia, PA, USA.""}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'J Ricardo', 'Initials': 'JR', 'LastName': 'Carhuapoma', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Carlos S', 'Initials': 'CS', 'LastName': 'Kase', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kennedy R', 'Initials': 'KR', 'LastName': 'Lees', 'Affiliation': 'School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Betz', 'Affiliation': 'Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Avadhani', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Caron', 'Affiliation': 'University of Texas Health, San Antonio, TX, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Harrigan', 'Affiliation': 'University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Carlson', 'Affiliation': 'University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Bulters', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'LeDoux', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Cully', 'Initials': 'C', 'LastName': 'Cobb', 'Affiliation': 'Mercy Neurological Institute Stroke Center, Sacramento, California, USA.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Gupta', 'Affiliation': 'Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Kitagawa', 'Affiliation': 'University of Texas, McGovern Medical Center, Houston, TX, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Chicoine', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Hiren', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Salford Royal Hospital, Salford, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dodd', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Camarata', 'Affiliation': 'University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Wolfe', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Stadnik', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'P Lynn', 'Initials': 'PL', 'LastName': 'Money', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Newcastle Royal Infirmary, Newcastle, UK.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Sarabia', 'Affiliation': 'Hospital Universitario Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Sagi', 'Initials': 'S', 'LastName': 'Harnof', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Pal', 'Initials': 'P', 'LastName': 'Barzo', 'Affiliation': 'University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Unterberg', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jeanne S', 'Initials': 'JS', 'LastName': 'Teitelbaum', 'Affiliation': 'Montreal Neurological Institute and Hospital at McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Guangzhou Neuroscience Institute, Guangzhou Liuhua Qiao Hospital, Guangzhou, China.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health China at Peking University Health Science Center, Beijing, China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Mendelow', 'Affiliation': 'Newcastle University, Newcastle, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gregson', 'Affiliation': 'Newcastle University, Newcastle, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': 'National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vespa', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Issam A', 'Initials': 'IA', 'LastName': 'Awad', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)30195-3']
751,30994576,"Sexual frequency and pain in a randomized clinical trial of vaginal estradiol tablets, moisturizer, and placebo in postmenopausal women.","OBJECTIVE


To evaluate the efficacy of two common interventions for bothersome postmenopausal vaginal symptoms on improving sexual frequency and pain.
METHODS


This is a post-hoc analysis of data from a 12-week double-blind placebo-controlled trial that randomized postmenopausal women (ages 45-70 years) with moderate-severe genitourinary discomfort to vaginal 10 μg estradiol tablet plus placebo gel (n = 102), placebo tablet plus vaginal moisturizer (n = 100), or dual placebo (n = 100). Outcomes were proportion of sexually active women at 12 weeks, frequency of sexual activity, and pain severity with sexual activity (0-3 scale). Consistent with the original study design, comparisons were made between each active arm and the dual placebo arm.
RESULTS


Most women enrolled in the trial, 294/302 (97%), had sufficient data to be included in this analysis. Mean age of participants was 61 years, most were white (88%), college educated (66%), and most reported sexual activity in the month before enrollment (81%). After 12 weeks of treatment, a similar proportion of women in the vaginal estrogen and dual placebo groups reported sexual activity in the past week (50% and 40%; P = 0.10) and the past month (78% and 84%, P = 0.52). Mean (standard deviation) pain with sexual activity scores at 12 weeks were similar between vaginal estrogen (1.0 [1.0]) and placebo (0.9 [0.9], P = 0.52] groups. The proportion sexually active at 12 weeks (35%) and mean (standard deviation) pain severity in the vaginal moisturizer group (1.1 [0.9]) did not differ from placebo (P = 0.36).
CONCLUSIONS


Compared to placebo, neither low-dose vaginal estradiol nor vaginal moisturizer treatment over 12 weeks resulted in significantly greater increases in the proportions of women reporting sexual activity or improvement in pain scores with sexual activity.
TRIAL REGISTRATION


Clinical trials.gov: NCT02516202.",2019,"Compared to placebo, neither low-dose vaginal estradiol nor vaginal moisturizer treatment over 12 weeks resulted in significantly greater increases in the proportions of women reporting sexual activity or improvement in pain scores with sexual activity.
","['postmenopausal women', 'n = 102', 'Mean age of participants was 61 years, most were white (88%), college educated (66', 'randomized postmenopausal women (ages 45-70 years) with moderate-severe genitourinary discomfort to vaginal 10\u200aμg']","['vaginal estradiol tablets, moisturizer, and placebo', 'estradiol tablet plus placebo gel', 'placebo', 'placebo tablet plus vaginal moisturizer (n\u200a=\u200a100), or dual placebo']","['proportion sexually active', 'mean (standard deviation) pain severity', 'Sexual frequency and pain', 'Mean (standard deviation) pain with sexual activity scores', 'sexual activity', 'pain scores with sexual activity', 'sexual frequency and pain', 'frequency of sexual activity, and pain severity with sexual activity', 'proportions of women reporting sexual activity', 'bothersome postmenopausal vaginal symptoms']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",102.0,0.707351,"Compared to placebo, neither low-dose vaginal estradiol nor vaginal moisturizer treatment over 12 weeks resulted in significantly greater increases in the proportions of women reporting sexual activity or improvement in pain scores with sexual activity.
","[{'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larson', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Diem', 'Affiliation': 'Departments of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': 'Department of Family Medicine and Public Health, University of California at San Diego, La Jolla, CA.'}, {'ForeName': 'Bette', 'Initials': 'B', 'LastName': 'Caan', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland of Northern California, CA.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Shifren', 'Affiliation': 'Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Woods', 'Affiliation': 'University of Washington School of Nursing, Seattle, WA.'}, {'ForeName': 'Julia R', 'Initials': 'JR', 'LastName': 'Heiman', 'Affiliation': 'Kinsey Institute for Research in Sex, Gender and Reproduction, Psychological and Brain Sciences, Indiana University, Bloomington, IN.'}, {'ForeName': 'Stacy T', 'Initials': 'ST', 'LastName': 'Lindau', 'Affiliation': 'Departments of Obstetrics and Gynecology and Medicine-Geriatrics and Palliative Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001341']
752,30623420,Marine omega-3 fatty acid intake and survival of stage III colon cancer according to tumor molecular markers in NCCTG Phase III trial N0147 (Alliance).,"Marine omega-3 polyunsaturated fatty acids (MO3PUFAs) have anticancer properties and may improve colon cancer survival. However, it remains unknown whether the benefit differs by tumor molecular subtype. We examined data from a phase III randomized trial of FOLFOX or FOLFOX + cetuximab among 1,735 stage III colon cancer patients who completed a dietary questionnaire at enrollment. Multivariable hazard ratios and 95% confidence intervals (CIs) were calculated for the association between MO3PUFA and disease-free survival (DFS) and overall survival according to KRAS and BRAF V600E  mutations and DNA mismatch repair (MMR) status. Higher MO3PUFA intake was associated with improved 3-year DFS for KRAS wild-type tumors (77% vs. 73%; HR: 0.84; 95% CI: 0.67-1.05) but not KRAS-mutant tumors (64% vs. 70%; HR: 1.30; 95% CI: 0.97-1.73; P interaction  = 0.02). Similar heterogeneity was found by MMR (P interaction  = 0.14): higher MO3PUFA was associated with better 3-year DFS for tumors with deficient MMR (72% vs. 67%) but not proficient MMR (72% vs. 72%). No heterogeneity was found by BRAF V600E  mutation. Similar findings were obtained for overall survival. In conclusion, we found a suggestive beneficial association between higher MO3PUFA intake and improved survival among stage III colon cancer patients with wild-type KRAS and deficient MMR. Given the relatively small number of cases with tumor molecular assessments, further studies, preferably through pooled analyses of multiples cohorts, are needed to validate our findings.",2019,Similar heterogeneity was found by MMR (P interaction  = 0.14): higher MO3PUFA was associated with better 3-year DFS for tumors with deficient MMR (72% vs. 67%) but not proficient MMR (72% vs. 72%).,"['1,735 stage III colon cancer patients who completed a dietary questionnaire at enrollment', 'stage III colon cancer patients with wild-type KRAS and deficient MMR']","['Marine omega-3 polyunsaturated fatty acids (MO3PUFAs', 'Marine omega-3 fatty acid intake', 'FOLFOX or FOLFOX + cetuximab']","['colon cancer survival', 'survival', 'MO3PUFA and disease-free survival (DFS) and overall survival', '3-year DFS', 'overall survival']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0556124', 'cui_str': 'N-3 fatty acid intake (observable entity)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.116466,Similar heterogeneity was found by MMR (P interaction  = 0.14): higher MO3PUFA was associated with better 3-year DFS for tumors with deficient MMR (72% vs. 67%) but not proficient MMR (72% vs. 72%).,"[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology and Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Zemla', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hull', 'Affiliation': ""Leeds Institute of Biomedical & Clinical Sciences, University of Leeds, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Limburg', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology and Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners Cancer Care and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",International journal of cancer,['10.1002/ijc.32113']
753,30418528,"Measles Immunity at 4.5 Years of Age Following Vaccination at 9 and 15-18 Months of Age Among Human Immunodeficiency Virus (HIV)-infected, HIV-exposed-uninfected, and HIV-unexposed Children.","BACKGROUND


Human immunodeficiency virus (HIV)-infected and HIV-exposed-uninfected (HEU) children may be at increased risk of measles infection due to waning of immunity following vaccination. We evaluated persistence of antibodies to measles vaccination at 4.5 years of age in HIV-unexposed, HEU, and HIV-infected children with CD4+ ≥25% previously randomized to immediate antiretroviral therapy (ART) interrupted at 12 months (HIV/Immed-ART-12), 24 months (HIV/Immed-ART-24), or when clinically/immunologically indicated (HIV/Def-ART). The HIV/Def-ART group initiated ART by median 5.8 (interquartile range, 4.4-10.3) months of age.
METHODS


In this study, HIV-unexposed (n = 95), HEU (n = 84), HIV/Immed-ART-12 (n = 70), HIV/Immed-ART-24 (n = 70), and HIV/Def-ART (n = 62) children were scheduled to receive measles vaccination at age 9 and 15-18 months. Antimeasles serum immunoglobulin G titers were quantified using enzyme-linked immunosorbent assay at 4.5 years.
RESULTS


Compared with HIV-unexposed children (2860 mIU/mL), measles antibody geometric mean titers (GMTs) were significantly lower in both HIV/Immed-ART-12 (571; P < .001) and HIV/Immed-ART-24 (1136; P < .001) but similar in the HIV/Def-ART (2777) and HEU (3242) groups. Furthermore, compared with HIV-unexposed, antibody titers ≥330 mIU/mL (ie, presumed serocorrelate for protection; 99%) were also significantly lower in HIV/Immed-ART-12 (70%; P < .001) and HIV/Immed-ART-24 (83%; P < .001) but similar in the HIV/Def-ART (90%) and HEU (98%) groups.
CONCLUSIONS


HIV-infected children in whom ART was interrupted at either 12 or 24 months had lower GMTs and lower proportions with seroprotective titers than HIV-unexposed children, indicating a potential downside of ART treatment interruption.
CLINICAL TRIALS REGISTRATION


NCT00099658 and NCT00102960.",2019,"Conclusions


HIV-infected children in whom ART was interrupted at either 12 or 24 months of age had lower GMTs and lower proportions with seroprotective titres than HIV-unexposed children; indicating a potential downside of ART treatment interruption.","['HIV-unexposed (n=95), HEU (n=84), HIV/Immed-ART-12 (n=70), HIV/Immed-ART-24 (n=70), and HIV/Def-ART (n=62) children were scheduled to receive measles vaccination at 9 and 15-18 months of age', 'Measles immunity at 4.5 years of age following vaccination at 9 and 15-18 months of age among HIV-infected, HIV-exposed-uninfected and HIV-unexposed children', '4.5 years of age in HIV-unexposed, HEU, and HIV-infected children with CD4+≥25% previously randomised to', 'participants from 6-12 weeks through 4.5 years of age']",['immediate antiretroviral therapy'],"['measles antibody geometric mean titres (GMTs', 'Anti-measles serum IgG titres']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0054282', 'cui_str': 'tribufos'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0042201', 'cui_str': 'Measles vaccination (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1168051', 'cui_str': 'Measles antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.291677,"Conclusions


HIV-infected children in whom ART was interrupted at either 12 or 24 months of age had lower GMTs and lower proportions with seroprotective titres than HIV-unexposed children; indicating a potential downside of ART treatment interruption.","[{'ForeName': 'Eleonora A M L', 'Initials': 'EAML', 'LastName': 'Mutsaerts', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Martijn N', 'Initials': 'MN', 'LastName': 'van Rijswijk', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Klipstein-Grobusch', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Kennedy', 'Initials': 'K', 'LastName': 'Otwombe', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Cotton', 'Affiliation': 'Family Clinical Research Unit, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy964']
754,8079572,[The reactogenic properties and antigenic activity of inactivated 3-component influenza vaccines used intranasally].,,1993,,[],[],[],[],[],[],,0.00937651,,"[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Erofeeva', 'Affiliation': ''}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Maksakova', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mikhaĭlov', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Kostiuchek', 'Affiliation': ''}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Marinich', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Tsaritsyna', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Shadrin', 'Affiliation': ''}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Subbotina', 'Affiliation': ''}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Sidorova', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Voĭtsekhovskaia', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
755,30657439,Associations between causal attributions for obesity and long-term weight loss.,"Obesity is a complex disease caused by a wide array of behavioral, biological, and environmental factors. However, obesity is often attributed to oversimplified and stigmatizing causal factors such as laziness, lack of willpower, and failure to take personal responsibility for one's health. Understanding of the causal factors that contribute to obesity among people with obesity may affect their weight management efforts. The current study explored associations between causal attributions for obesity and long-term weight loss, as well as examined potential changes in attributions with weight reduction. The 16-item Causal Attributions for Obesity scale (rated 1-7) was administered to 178 patients seeking behavioral/pharmacological weight-loss treatment. Causal attributions and weight were assessed at baseline, after 14 weeks of a low-calorie diet, and again at weeks 24 and 52 of a subsequent randomized trial (i.e., 66 weeks total). Logistic and linear regression examined effects of baseline causal attribution ratings on weight loss. Higher baseline ratings of personal responsibility attributions predicted 38% reduced odds of achieving ≥10% weight loss at week 52 (p = 0.02). Causal attribution ratings did not change over time or correlate continuously with weight change. Thus, attributing obesity to a failure of personal responsibility may impair long-term weight management efforts for individuals seeking ≥10% weight loss. Targeted techniques are needed to reduce patients' stigmatizing beliefs about the causes of obesity.",2019,Higher baseline ratings of personal responsibility attributions predicted 38% reduced odds of achieving ≥10% weight loss at week 52 (p = 0.02).,['178 patients seeking behavioral/pharmacological weight-loss treatment'],[],"['Causal attributions and weight', 'weight loss', 'Causal attribution ratings', '16-item Causal Attributions for Obesity scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0222045'}]",178.0,0.0131796,Higher baseline ratings of personal responsibility attributions predicted 38% reduced odds of achieving ≥10% weight loss at week 52 (p = 0.02).,"[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Allison', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}, {'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'a Center for Weight and Eating Disorders, Department of Psychiatry , Perelman School of Medicine at the University of Pennsylvania , Philadelphia , PA.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2018.1556202']
756,31120534,Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality.,"Importance


Black men are more likely to die of prostate cancer than white men. In men with similar stages of disease, the contribution of biological vs nonbiological differences to this observed disparity is unclear.
Objective


To quantify the association of black race with long-term survival outcomes after controlling for known prognostic variables and access to care among men with prostate cancer.
Design, Setting, and Participants


This multiple-cohort study included updated individual patient-level data of men with clinical T1-4N0-1M0 prostate cancer from the following 3 cohorts: Surveillance, Epidemiology, and End Results (SEER [n = 296 273]); 5 equal-access regional medical centers within the Veterans Affairs health system (VA [n = 3972]); and 4 pooled National Cancer Institute-sponsored Radiation Therapy Oncology Group phase 3 randomized clinical trials (RCTs [n = 5854]). Data were collected in the 3 cohorts from January 1, 1992, through December 31, 2013, and analyzed from April 27, 2017, through April 13, 2019.
Exposures


In the VA and RCT cohorts, all patients received surgery and radiotherapy, respectively, with curative intent. In SEER, radical treatment, hormone therapy, or conservative management were received.
Main Outcomes and Measures


Prostate cancer-specific mortality (PCSM). Secondary measures included other-cause mortality (OCM). To adjust for demographic-, cancer-, and treatment-related baseline differences, inverse probability weighting (IPW) was performed.
Results


Among the 306 100 participants included in the analysis (mean [SD] age, 64.9 [8.9] years), black men constituted 52 840 patients (17.8%) in the SEER cohort, 1513 (38.1%) in the VA cohort, and 1129 (19.3%) in the RCT cohort. Black race was associated with an increased age-adjusted PCSM hazard (subdistribution hazard ratio [sHR], 1.30; 95% CI, 1.23-1.37; P < .001) within the SEER cohort. After IPW adjustment, black race was associated with a 0.5% (95% CI, 0.2%-0.9%) increase in PCSM at 10 years after diagnosis (sHR, 1.09; 95% CI, 1.04-1.15; P < .001), with no significant difference for high-risk men (sHR, 1.04; 95% CI, 0.97-1.12; P = .29). No significant differences in PCSM were found in the VA IPW cohort (sHR, 0.85; 95% CI, 0.56-1.30; P = .46), and black men had a significantly lower hazard in the RCT IPW cohort (sHR, 0.81; 95% CI, 0.66-0.99; P = .04). Black men had a significantly increased hazard of OCM in the SEER (sHR, 1.30; 95% CI, 1.27-1.34; P < .001) and RCT (sHR, 1.17; 95% CI, 1.06-1.29; P = .002) IPW cohorts.
Conclusions and Relevance


In this study, after adjustment for nonbiological differences, notably access to care and standardized treatment, black race did not appear to be associated with inferior stage-for-stage PCSM. A large disparity remained in OCM for black men with nonmetastatic prostate cancer.",2019,"No significant differences in PCSM were found in the VA IPW cohort (sHR, 0.85; 95% CI, 0.56-1.30; P = .46), and black men had a significantly lower hazard in the RCT IPW cohort (sHR, 0.81; 95% CI, 0.66-0.99; P = .04).","['Participants\n\n\nThis multiple-cohort study included updated individual patient-level data of men with clinical T1-4N0-1M0 prostate cancer from the following 3 cohorts: Surveillance, Epidemiology, and End Results (SEER [n\u2009', '3 cohorts from January 1, 1992, through December 31, 2013, and analyzed from April 27, 2017, through April 13, 2019', 'black men with nonmetastatic prostate cancer', 'men with prostate cancer', '306 100 participants included in the analysis (mean [SD] age, 64.9 [8.9] years), black men constituted\u200952\u202f840 patients (17.8%) in the SEER cohort, 1513 (38.1%) in the VA cohort, and 1129 (19.3%) in the RCT cohort', 'Importance\n\n\nBlack men', '296\u202f273]); 5 equal-access regional medical centers within the Veterans Affairs health system (VA [n\u2009=\u20093972]); and 4 pooled National Cancer Institute-sponsored Radiation Therapy Oncology Group phase 3 randomized clinical trials (RCTs [n\u2009=\u20095854']",['OCM'],"['black race', 'hazard of OCM', 'probability weighting (IPW', 'cause mortality (OCM', 'Measures\n\n\nProstate cancer-specific mortality (PCSM', 'PCSM', 'Black Race']","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",[],"[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",306100.0,0.205254,"No significant differences in PCSM were found in the VA IPW cohort (sHR, 0.85; 95% CI, 0.56-1.30; P = .46), and black men had a significantly lower hazard in the RCT IPW cohort (sHR, 0.81; 95% CI, 0.66-0.99; P = .04).","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Dess', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hartman', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Mahal', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Payal D', 'Initials': 'PD', 'LastName': 'Soni', 'Affiliation': 'Department of Radiation Oncology, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Jackson', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California, San Francisco.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Amling', 'Affiliation': 'Department of Urology, Oregon Health and Science University, Portland.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Aronson', 'Affiliation': 'Department of Urology, University of California, Los Angeles.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Kane', 'Affiliation': 'Department of Urology, University of California, San Diego.'}, {'ForeName': 'Martha K', 'Initials': 'MK', 'LastName': 'Terris', 'Affiliation': 'Department of Urology, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Zumsteg', 'Affiliation': 'Department of Radiation Oncology, Cedars Sinai, West Hollywood, California.'}, {'ForeName': 'Santino', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Osborne', 'Affiliation': 'Department of Radiology, Weill Cornell, New York, New York.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Morgan', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Department of Pathology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Simpa S', 'Initials': 'SS', 'LastName': 'Salami', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Amar U', 'Initials': 'AU', 'LastName': 'Kishan', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mack', 'Initials': 'M', 'LastName': 'Roach', 'Affiliation': 'Department of Urology, University of California, San Francisco.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Department of Urology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars Sinai, West Hollywood, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Urology, University of California, San Francisco.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dignam', 'Affiliation': 'Department of Biostatistics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Schipper', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}]",JAMA oncology,['10.1001/jamaoncol.2019.0826']
757,30543350,Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib: The SURTIME Randomized Clinical Trial.,"Importance


In clinical practice, patients with primary metastatic renal cell carcinoma (mRCC) have been offered cytoreductive nephrectomy (CN) followed by targeted therapy, but the optimal sequence of surgery and systemic therapy is unknown.
Objective


To examine whether a period of sunitinib therapy before CN improves outcome compared with immediate CN followed by sunitinib.
Design, Setting, and Participants


This randomized clinical trial began as a phase 3 trial on July 14, 2010, and continued until March 24, 2016, with a median follow-up of 3.3 years and a clinical cutoff date for this report of May 5, 2017. Patients with mRCC of clear cell subtype, resectable primary tumor, and 3 or fewer surgical risk factors were studied.
Interventions


Immediate CN followed by sunitinib therapy vs treatment with 3 cycles of sunitinib followed by CN in the absence of progression followed by sunitinib therapy.
Main Outcomes and Measures


Progression-free survival was the primary end point, which needed a sample size of 458 patients. Because of poor accrual, the independent data monitoring committee endorsed reporting the intention-to-treat 28-week progression-free rate (PFR) instead. Overall survival (OS), adverse events, and postoperative progression were secondary end points.
Results


The study closed after 5.7 years with 99 patients (80 men and 19 women; mean [SD] age, 60 [8.5] years). The 28-week PFR was 42% in the immediate CN arm (n = 50) and 43% in the deferred CN arm (n = 49) (P = .61). The intention-to-treat OS hazard ratio of deferred vs immediate CN was 0.57 (95% CI, 0.34-0.95; P = .03), with a median OS of 32.4 months (95% CI, 14.5-65.3 months) in the deferred CN arm and 15.0 months (95% CI, 9.3-29.5 months) in the immediate CN arm. In the deferred CN arm, 48 of 49 patients (98%; 95% CI, 89%-100%) received sunitinib vs 40 of 50 (80%; 95% CI, 67%-89%) in the immediate arm. Systemic progression before planned CN in the deferred CN arm resulted in a per-protocol recommendation against nephrectomy in 14 patients (29%; 95% CI, 18%-43%).
Conclusions and Relevance


Deferred CN did not improve the 28-week PFR. With the deferred approach, more patients received sunitinib and OS results were higher. Pretreatment with sunitinib may identify patients with inherent resistance to systemic therapy before planned CN. This evidence complements recent data from randomized clinical trials to inform treatment decisions in patients with primary clear cell mRCC requiring sunitinib.
Trial Registration


ClinicalTrials.gov identifier: NCT01099423.",2019,The intention-to-treat OS hazard ratio of deferred vs immediate CN was 0.57,"['July 14, 2010, and continued until March 24, 2016, with a median follow-up of 3.3 years and a clinical cutoff date for this report of May 5, 2017', '99 patients (80 men and 19 women; mean [SD] age, 60 [8.5] years', 'patients with primary metastatic renal cell carcinoma (mRCC', 'Patients with mRCC of clear cell subtype, resectable primary tumor, and 3 or fewer surgical risk factors were studied', 'patients with primary clear cell mRCC requiring sunitinib', 'Patients with Synchronous Metastatic Renal Cell Carcinoma', 'patients with inherent resistance to systemic therapy before planned CN']","['Sunitinib', 'Immediate vs Deferred Cytoreductive Nephrectomy', 'cytoreductive nephrectomy (CN', 'sunitinib']","['Measures\n\n\nProgression-free survival', '28-week PFR', 'Overall survival (OS), adverse events, and postoperative progression', 'Systemic progression']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]",,0.253539,The intention-to-treat OS hazard ratio of deferred vs immediate CN was 0.57,"[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mulders', 'Affiliation': 'Department of Urology, Radboud University Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jewett', 'Affiliation': 'Department of Urology, Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Department of Oncology, Cardiff Hospital, Wales, United Kingdom.'}, {'ForeName': 'Johannes V', 'Initials': 'JV', 'LastName': 'van Thienen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van Velthoven', 'Affiliation': 'Department of Urology, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Pilar Laguna', 'Affiliation': 'Department of Urology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Division of Medical Oncology, QEII Health Sciences Center, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Harm H E', 'Initials': 'HHE', 'LastName': 'van Melick', 'Affiliation': 'Department of Urology, Saint Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Maureen J', 'Initials': 'MJ', 'LastName': 'Aarts', 'Affiliation': 'Department of Oncology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Lattouf', 'Affiliation': 'Department of Surgery-Urology, University of Montreal Hospital Center, Quebec, Ontario, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Oncology, The Royal Free Hospital and Queen Mary University, London, United Kingdom.'}, {'ForeName': 'Igle Jan', 'Initials': 'IJ', 'LastName': 'de Jong Md PhD', 'Affiliation': 'Department of Urology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Department of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Collette', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Collette', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",JAMA oncology,['10.1001/jamaoncol.2018.5543']
758,30489140,A pilot study comparing peer supported web-based CBT to self-managed web CBT for primary care veterans with PTSD and hazardous alcohol use.,"OBJECTIVE


Many combat veterans struggle with posttraumatic stress disorder (PTSD) and hazardous alcohol use and are hesitant to engage in behavioral health services. Combining peer support with an eHealth intervention may overcome many barriers to care. This pilot study investigated the feasibility of adding peer support to a web-based cognitive behavior therapy (CBT) targeting PTSD symptoms and hazardous drinking, called Thinking Forward.
METHOD


Thirty primary care patients with PTSD and hazardous alcohol use were randomized to receive Thinking Forward with or without peer support. Participants were assessed at pretreatment, posttreatment, and 24-week follow-up. Feasibility was analyzed with descriptive statistics. Preliminary outcomes were analyzed with multilevel modeling and effect sizes are presented.
RESULTS


Peer support specialists can be feasibly trained to support the Thinking Forward intervention with good fidelity. Both participants and peers reported good satisfaction with the protocol; although peers discussed a mismatch between the philosophies of peer support and diagnostically focused CBT. All participants experienced significant improvements in PTSD, quality of life, resiliency, and coping from pre- to posttreatment, with no differences between conditions. Pretreatment patient activation predicted outcomes regardless of whether participants received peer support.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


Peer support interventions to facilitate eHealth programs should strive to be consistent with the person-centered, recovery orientation of peer support, explicitly focus on patient activation, and consider characteristics of the patients, such as their level of problem recognition and willingness to engage in traditional behavioral health modalities. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"All participants experienced significant improvements in PTSD, quality of life, resiliency, and coping from pre- to posttreatment, with no differences between conditions.","['Thirty primary care patients with PTSD and hazardous alcohol use', 'primary care veterans with PTSD and hazardous alcohol use', 'veterans struggle with posttraumatic stress disorder (PTSD']","['Thinking Forward with or without peer support', 'peer support to a web-based cognitive behavior therapy (CBT', 'peer supported web-based CBT to self-managed web CBT']","['PTSD, quality of life, resiliency, and coping from pre- to posttreatment']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0034380'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0234576,"All participants experienced significant improvements in PTSD, quality of life, resiliency, and coping from pre- to posttreatment, with no differences between conditions.","[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Possemato', 'Affiliation': 'Veterans Affairs Center for Integrated Healthcare.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Johnson', 'Affiliation': 'Veterans Affairs Center for Integrated Healthcare.'}, {'ForeName': 'J Bronte', 'Initials': 'JB', 'LastName': 'Emery', 'Affiliation': 'Veterans Affairs Center for Integrated Healthcare.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'Veterans Affairs Center for Integrated Healthcare.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Acosta', 'Affiliation': 'National Development Research Institutes.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Dartmouth College.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rosenblum', 'Affiliation': 'National Development Research Institutes.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'National Development Research Institutes.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000334']
759,30653490,A randomized trial of AmBisome monotherapy and AmBisome and miltefosine combination to treat visceral leishmaniasis in HIV co-infected patients in Ethiopia.,"BACKGROUND


Visceral leishmaniasis (VL) in human immunodeficiency virus (HIV) co-infected patients requires special case management. AmBisome monotherapy at 40 mg/kg is recommended by the World Health Organization. The objective of the study was to assess if a combination of a lower dose of AmBisome with miltefosine would show acceptable efficacy at the end of treatment.
METHODOLOGY/PRINCIPAL FINDINGS


An open-label, non-comparative randomized trial of AmBisome (30 mg/kg) with miltefosine (100 mg/day for 28 days), and AmBisome monotherapy (40 mg/kg) was conducted in Ethiopian VL patients co-infected with HIV (NCT02011958). A sequential design was used with a triangular continuation region. The primary outcome was parasite clearance at day 29, after the first round of treatment. Patients with clinical improvement but without parasite clearance at day 29 received a second round of the allocated treatment. Efficacy was evaluated again at day 58, after completion of treatment. Recruitment was stopped after inclusion of 19 and 39 patients in monotherapy and combination arms respectively, as per pre-specified stopping rules. At D29, intention-to-treat efficacy in the AmBisome arm was 70% (95% CI 45-87%) in the unadjusted analysis, and 50% (95% CI 27-73%) in the adjusted analysis, while in the combination arm, it was 81% (95% CI 67-90%) and 67% (95% CI 48-82%) respectively. At D58, the adjusted efficacy was 55% (95% CI 32-78%) in the monotherapy arm, and 88% (95% CI 79-98%) in the combination arm. No major safety concerns related to the study medication were identified. Ten SAEs were observed within the treatment period, and 4 deaths unrelated to the study medication.
CONCLUSIONS/SIGNIFICANCE


The extended treatment strategy with the combination regimen showed the highest documented efficacy in HIV-VL patients; these results support a recommendation of this regimen as first-line treatment strategy for HIV-VL patients in eastern Africa.
TRIAL REGISTRATION NUMBER


www.clinicaltrials.gov NCT02011958.",2019,"At D58, the adjusted efficacy was 55% (95% CI 32-78%) in the monotherapy arm, and 88% (95% CI 79-98%) in the combination arm.","['HIV-VL patients in eastern Africa', 'HIV co-infected patients in Ethiopia']","['AmBisome monotherapy and AmBisome and miltefosine combination', 'AmBisome', 'AmBisome monotherapy', 'miltefosine']","['parasite clearance', 'adjusted efficacy', 'intention-to-treat efficacy', 'Efficacy']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001741', 'cui_str': 'East Africa'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0591076', 'cui_str': 'AmBisome'}, {'cui': 'C0068006', 'cui_str': 'miltefosine'}]","[{'cui': 'C0521066', 'cui_str': 'parasites'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",,0.217939,"At D58, the adjusted efficacy was 55% (95% CI 32-78%) in the monotherapy arm, and 88% (95% CI 79-98%) in the combination arm.","[{'ForeName': 'Ermias', 'Initials': 'E', 'LastName': 'Diro', 'Affiliation': 'Leishmaniasis Research and Treatment Centre, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Blesson', 'Affiliation': 'Research & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}, {'ForeName': 'Tansy', 'Initials': 'T', 'LastName': 'Edwards', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Koert', 'Initials': 'K', 'LastName': 'Ritmeijer', 'Affiliation': 'Médecins sans Frontières, Amsterdam, the Netherlands.'}, {'ForeName': 'Helina', 'Initials': 'H', 'LastName': 'Fikre', 'Affiliation': 'Leishmaniasis Research and Treatment Centre, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Henok', 'Initials': 'H', 'LastName': 'Admassu', 'Affiliation': 'Abdurafi Health Centre, Médecins sans Frontières, Abdurafi, Ethiopia.'}, {'ForeName': 'Aderajew', 'Initials': 'A', 'LastName': 'Kibret', 'Affiliation': 'Abdurafi Health Centre, Médecins sans Frontières, Abdurafi, Ethiopia.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Ellis', 'Affiliation': 'Research & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': 'Bardonneau', 'Affiliation': 'Research & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}, {'ForeName': 'Eduard E', 'Initials': 'EE', 'LastName': 'Zijlstra', 'Affiliation': 'Research & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}, {'ForeName': 'Peninah', 'Initials': 'P', 'LastName': 'Soipei', 'Affiliation': 'Drugs for Neglected Diseases initiative, Nairobi, Kenya.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mutinda', 'Affiliation': 'Drugs for Neglected Diseases initiative, Nairobi, Kenya.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Omollo', 'Affiliation': 'Drugs for Neglected Diseases initiative, Nairobi, Kenya.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kimutai', 'Affiliation': 'Drugs for Neglected Diseases initiative, Nairobi, Kenya.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Omwalo', 'Affiliation': 'Drugs for Neglected Diseases initiative, Nairobi, Kenya.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Wasunna', 'Affiliation': 'Drugs for Neglected Diseases initiative, Nairobi, Kenya.'}, {'ForeName': 'Fentahun', 'Initials': 'F', 'LastName': 'Tadesse', 'Affiliation': 'Neglected Tropical Diseases, Federal Ministry of Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Alves', 'Affiliation': 'Research & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Strub-Wourgaft', 'Affiliation': 'Research & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}, {'ForeName': 'Asrat', 'Initials': 'A', 'LastName': 'Hailu', 'Affiliation': 'Department of Microbiology, Immunology, and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alvar', 'Affiliation': 'Research & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0006988']
760,31196169,"A realist process evaluation of Enhanced Triple P for Baby and Mellow Bumps, within a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE): study protocol for a randomized controlled trial.","BACKGROUND


THRIVE is a three-arm randomised controlled trial (RCT) that aims to evaluate whether antenatal and early postnatal interventions, Enhanced Triple B for Baby (ETPB) plus care as usual (CAU) or Mellow Bumps (MB) plus CAU (versus CAU alone), can: 1) improve the mental health and well-being of pregnant women with complex health and social care needs; 2) improve mother-infant bonding and interaction; 3) reduce child maltreatment; and 4) improve child language acquisition. This paper focuses on THRIVE's realist process evaluation, which is carefully monitoring what is happening in the RCT.
METHODS


Realistic evaluation provides the theoretical rationale for the process evaluation. We question: 1) how faithfully are MB and ETPB implemented? 2) What are the mechanisms by which they work, if they do, and who do they work for and how? 3) What contextual factors are necessary for the programmes to function, or might prevent them functioning? The mixed-methods design includes quantitative measures, which are pre- and post-training/intervention questionnaires for facilitators and mothers-to-be, and post-session evaluation forms. Qualitative data collection methods include participant observation of facilitator training and the delivery of a series of antenatal sessions in selected intervention groups (n = 3 for ETPB and n = 3 for MB), semi-structured interviews with facilitators, pregnant women, partners, and referring facilitators, and telephone interviews examining the content of the postnatal components of ETPB and MB.
DISCUSSION


The findings of this process evaluation will help researchers and decision makers interpret the outcomes of THRIVE. It will provide a greater understanding of: how the interventions work (if they do); the extent and quality of their implementation; contextual factors facilitating and constraining intervention functioning; variations in response within and between subgroups of vulnerable parents; and benefits or unintended consequences of either intervention. Few studies to date have published detailed research protocols illustrating how realist process evaluation is designed and conducted as an integral part of a randomised controlled trial.
TRIAL REGISTRATION


ISRCTN, ISRCTN21656568 . Registered on 8 November 2013.",2019,"Qualitative data collection methods include participant observation of facilitator training and the delivery of a series of antenatal sessions in selected intervention groups (n = 3 for ETPB and n = 3 for MB), semi-structured interviews with facilitators, pregnant women, partners, and referring facilitators, and telephone interviews examining the content of the postnatal components of ETPB and MB.
",['Baby'],"['ETPB) plus care as usual (CAU) or Mellow Bumps (MB) plus CAU', 'ETPB and n\u2009=\xa03\u2009for MB), semi-structured interviews with facilitators, pregnant women, partners, and referring facilitators, and telephone interviews examining the content of the postnatal components of ETPB and MB']",['child language acquisition'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0077103', 'cui_str': 'Et(3)Pb'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0008081', 'cui_str': 'Child Language'}]",,0.130719,"Qualitative data collection methods include participant observation of facilitator training and the delivery of a series of antenatal sessions in selected intervention groups (n = 3 for ETPB and n = 3 for MB), semi-structured interviews with facilitators, pregnant women, partners, and referring facilitators, and telephone interviews examining the content of the postnatal components of ETPB and MB.
","[{'ForeName': 'Rosaleen', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'Glasgow Caledonian University, Psychology, Social Work and Allied Health Professionals, School of Health and Life Sciences, 4th Floor, George Moore Building, Cowcaddens Road, Glasgow, G4 0BA, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Buston', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow, G2 3AX, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wight', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow, G2 3AX, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McGee', 'Affiliation': 'Glasgow Caledonian University, Psychology, Social Work and Allied Health Professionals, School of Health and Life Sciences, 4th Floor, George Moore Building, Cowcaddens Road, Glasgow, G4 0BA, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Public Health Sciences, NHS Health Scotland, Gyle Square, 1 Gyle Crescent, Edinburgh, EH12 9EB, UK.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Henderson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow, G2 3AX, UK. marion.henderson@glasgow.ac.uk.'}]",Trials,['10.1186/s13063-019-3395-3']
761,30412233,A Community Choir Intervention to Promote Well-Being Among Diverse Older Adults: Results From the Community of Voices Trial.,"OBJECTIVES


To test effects of the Community of Voices choir intervention on the health, well-being, and health care costs of racial/ethnically diverse older adults.
METHOD


Twelve Administration-on-Aging-supported senior centers were cluster randomized into two groups: the intervention group started the choir immediately and a wait-list control group began the choir 6 months later. The choir program was designed for community-dwelling adults aged 60 years and older. The multimodal intervention comprises activities that engage participants cognitively, physically, and socially. Outcome measures assessed these three domains as well as health care utilization and costs. The intention-to-treat comparison was at 6 months.
RESULTS


The sample (N = 390) had a mean age of 71.3 years (SD = 7.2); 65% were nonwhite. Six-month retention was 92%. Compared to controls, intervention group members experienced significantly greater improvements in loneliness (p = .02; standardized effect size [ES = 0.34] and interest in life (p = .008, ES = 0.39). No significant group differences were observed for cognitive or physical outcomes or for health care costs.
DISCUSSION


Findings support adoption of community choirs for reducing loneliness and increasing interest in life among diverse older adults. Further efforts need to examine the mechanisms by which engagement in choirs improves aspects of well-being and reduces health disparities among older adults, including potential longer-term effects.
CLINICALTRIALS.GOV REGISTRATION


NCT01869179 registered January 9, 2013.",2020,"Compared to controls, intervention group members experienced significantly greater improvements in loneliness (p=0.02; standardized effect size (ES=0.34) and interest in life (p=0.008, ES=0.39).","['Diverse Older Adults', 'racial/ethnically diverse older adults', 'The sample (N=390) had a mean age of 71.3 years (SD=7.2); 65% were non-white', 'Method\n\n\nTwelve Administration-on-Aging-supported senior centers', 'community-dwelling adults aged 60 and over', 'diverse older adults', 'older adults']","['Community Choir Intervention', 'Community of Voices choir intervention', 'intervention group started the choir immediately and a wait-list control group began the choir 6 months later']","['loneliness', 'cognitive or physical outcomes or for healthcare costs', 'healthcare utilization and costs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",390.0,0.0333673,"Compared to controls, intervention group members experienced significantly greater improvements in loneliness (p=0.02; standardized effect size (ES=0.34) and interest in life (p=0.008, ES=0.39).","[{'ForeName': 'Julene K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Stewart', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acree', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Nápoles', 'Affiliation': 'Intramural Research Program, National Institute of Minority Health and Health Disparities, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Flatt', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Max', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gregorich', 'Affiliation': 'Center for Aging in Diverse Communities, University of California San Francisco, Bethesda, Maryland.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby132']
762,30252544,Asthma dissemination around patient-centered treatments in North Carolina (ADAPT-NC): a cluster randomized control trial evaluating dissemination of an evidence-based shared decision-making intervention for asthma management.,"Objective : To compare three dissemination approaches for implementing an asthma shared decision-making (SDM) intervention into primary care practices.  Methods : We randomized thirty practices into three study arms: (1) a facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention. Patient perceptions of SDM were assessed in the active intervention arms using a one-question anonymous survey. Logistic regression models compared the frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions) between the three arms.  Results : We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites. Patients were more likely to report that they participated equally with the provider in making the treatment decision in the facilitator-led sites (75% vs. 66%,  p  = 0.001). Comparisons of outcomes for patients in the facilitator-led ( n  = 1,658) and lunch-and-learn ( n  = 2,613) arms respectively vs. control ( n  = 2,273) showed no significant differences for ED visits (Odds Ratio [OR] [95%CI] = 0.77[0.57-1.04]; 0.83[0.66-1.07]), hospitalizations (OR [95%CI] = 1.30[0.59-2.89]; 1.40 [0.68-3.06]), or oral steroids (OR [95%CI] =0.95[0.79-1.15]; 1.03[0.81-1.06]).  Conclusion : Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach. While there was no significant difference in health outcomes between the three arms, the results were most likely confounded by a concurrent statewide asthma initiative and the pragmatic implementation of the intervention. These results offer support for the use of structured approaches such as facilitator-led dissemination of complex interventions into primary care practices.",2019,"CONCLUSION


Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach.","['We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites', 'Asthma dissemination around patient-centered treatments in North Carolina (ADAPT-NC']",['facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention'],"['health outcomes', 'frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions', 'ED visits']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",30.0,0.150132,"CONCLUSION


Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ludden', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Shade', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Reeves', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Madelyn', 'Initials': 'M', 'LastName': 'Welch', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Yhenneko J', 'Initials': 'YJ', 'LastName': 'Taylor', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Sveta', 'Initials': 'S', 'LastName': 'Mohanan', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McWilliams', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Halladay', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Tamera', 'Initials': 'T', 'LastName': 'Coyne-Beasley', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Division General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bray', 'Affiliation': 'Vidant Medical Group, Greenville, NC, USA.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Tapp', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1514630']
763,30500405,Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review.,"OBJECTIVES


The Consolidated Standards of Reporting Trials extension for the stepped-wedge cluster randomized trial (SW-CRT) is a recently published reporting guideline for SW-CRTs. We assess the quality of reporting of a recent sample of SW-CRTs.
STUDY DESIGN AND SETTING


Quality of reporting was asssessed according to the 26 items in the new guideline using a novel crowd sourcing methodology conducted independently and in duplicate, with random assignment, by 50 reviewers. We assessed reliability of the quality assessments, proposing this as a novel way to assess robustness of items in reporting guidelines.
RESULTS


Several items were well reported. Some items were very poorly reported, including several items that have unique requirements for the SW-CRT, such as the rationale for use of the design, description of the design, identification and recruitment of participants within clusters, and concealment of cluster allocation (not reported in more than 50% of the reports). Agreement across items was moderate (median percentage agreement was 76% [IQR 64 to 86]). Agreement was low for several items including the description of the trial design and why trial ended or stopped for example.
CONCLUSIONS


When reporting SW-CRTs, authors should pay particular attention to ensure clear reporting on the exact format of the design with justification, as well as how clusters and individuals were identified for inclusion in the study, and whether this was done before or after randomization of the clusters, which are crucial for risk of bias assessments. Some items, including why the trial ended, might either not be relevant to SW-CRTs or might be unclearly described in the statement.",2019,Agreement across items was moderate (median percentage agreement was 76% [IQR 64 to 86]).,"['Quality of reporting was asssessed according to the 26 items in the new guideline using a novel crowd sourcing methodology conducted independently and in duplicate, with random assignment, by 50 reviewers']",[],[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]",[],[],,0.105786,Agreement across items was moderate (median percentage agreement was 76% [IQR 64 to 86]).,"[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK. Electronic address: k.hemming@bham.ac.uk.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Carroll', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'Biostatistics, Monash University, Melbourne, Australia.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2018.11.017']
764,32144522,"Tranexamic acid attenuates inflammatory effect and modulates immune response in primary total knee arthroplasty: a randomized, placebo-controlled, pilot trial.","AIMS


To explore the effect of intravenous tranexamic acid (IV-TXA) on inflammation and immune response following primary total knee arthroplasty (TKA).
METHODS


Primary TKA patients (n = 125) were randomized into the following four groups: group A to receive placebo; group B to receive a single dose of 20 mg kg -1  IV-TXA and 20 mg of intravenous dexamethasone (IV-DXM); group C to receive six doses of IV-TXA (total dosage > 6 g); and group D to receive six doses of IV-TXA combined with three doses of IV-DXM (total dosage = 40 mg). The primary outcomes were C-reactive protein (CRP) and interleukin (IL)-6 levels and the secondary outcomes were complement C3 and C4 and T-cell subset levels, which were measured preoperatively and at 24 h, 48 h, 72 h, and 2 weeks postoperatively.
RESULTS


The postoperative peak CRP and IL-6 levels in group C (93.7 ± 22.2 mg L -1 , 108.8 ± 41.7 pg mL -1 ) were lower compared with those in group A (134.7 ± 28.8 mg L -1 , P < 0.01; 161.6 ± 64.4 pg mL -1 , P < 0.01). Groups B and D exhibited significantly lower CRP and IL-6 levels compared with groups A and C at 24 h, 48 h, and 72 h postoperatively (P < 0.05 for all). In group C, complement C3 and C4 levels were higher compared with those in group A at 48 h (0.967 ± 0.127 g L -1  vs. 0.792 ± 0.100 g L -1 , P < 0.01; 0.221 ± 0.046 g L -1  vs. 0.167 ± 0.028 g L -1 , P < 0.01) and 72 h (1.050 ± 0.181 g L -1  vs. 0.860 ± 0.126 g L -1 , P = 0.01; 0.240 ± 0.052 g L -1  vs. 0.182 ± 0.036 g L -1 , P < 0.01) postoperatively and CD3 and CD4 subset levels were higher compared with those in group B at 24 h postoperatively (66.78 ± 9.29% vs. 56.10 ± 12.47%, P < 0.05; 36.69 ± 5.78% vs. 28.39 ± 8.89%, P < 0.05).
CONCLUSION


Six doses of IV-TXA could attenuate the inflammatory effect, modulate the immune response, and reduce immunosuppression caused by DXM in patients after TKA.",2020,"Groups B and D exhibited significantly lower CRP and IL-6 levels compared with groups A and C at 24 h, 48 h, and 72 h postoperatively (P < 0.05 for all).","['Primary TKA patients (n\u2009=\u2009125', 'primary total knee arthroplasty (TKA', 'primary total knee arthroplasty']","['TXA and 20\xa0mg of intravenous dexamethasone (IV-DXM); group C to receive six doses of IV-TXA (total dosage\u2009', 'placebo', 'IV-TXA combined with three doses of IV-DXM', 'IV-TXA', 'Tranexamic acid', 'intravenous tranexamic acid (IV-TXA']","['inflammation and immune response', 'complement C3 and C4 levels', 'C-reactive protein (CRP) and interleukin (IL)-6 levels and the secondary outcomes were complement C3 and C4 and T-cell subset levels', 'postoperative peak CRP and IL-6 levels', 'CD3 and CD4 subset levels', 'CRP and IL-6 levels']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0009506', 'cui_str': 'Complement C3'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2362651', 'cui_str': 'T cell subsets'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",125.0,0.247443,"Groups B and D exhibited significantly lower CRP and IL-6 levels compared with groups A and C at 24 h, 48 h, and 72 h postoperatively (P < 0.05 for all).","[{'ForeName': 'Shaoyun', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery, The Third Hospital of Mianyang, Sichuan Mental Health Center, Mianyang, Sichuan, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, 37#Guoxue Road, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, 37#Guoxue Road, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Guorui', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, 37#Guoxue Road, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, 37#Guoxue Road, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, 37#Guoxue Road, Chengdu, 610041, Sichuan, People's Republic of China. peifuxinghx@163.com.""}]",Inflammopharmacology,['10.1007/s10787-020-00695-6']
765,32221596,A putative placebo analysis of the effects of sacubitril/valsartan in heart failure across the full range of ejection fraction.,"AIMS


The PARADIGM-HF and PARAGON-HF trials tested sacubitril/valsartan against active controls given renin-angiotensin system inhibitors (RASi) are ethically mandated in heart failure (HF) with reduced ejection fraction and are used in the vast majority of patients with HF with preserved ejection fraction. To estimate the effects of sacubitril/valsartan had it been tested against a placebo control, we made indirect comparisons of the effects of sacubitril/valsartan with putative placebos in HF across the full range of left ventricular ejection fraction (LVEF).
METHODS AND RESULTS


We analysed patient-level data from the PARADIGM-HF and PARAGON-HF trials (n = 13 194) and the CHARM-Alternative and CHARM-Preserved trials (n = 5050, candesartan vs. placebo). The rate ratio (RR) of sacubitril/valsartan vs. putative placebo was estimated by the product of the RR for sacubitril/valsartan vs. RASi and the RR for RASi vs. placebo. Total HF hospitalizations and cardiovascular death were analysed using the negative binomial method. Treatment effects were estimated using cubic spline methods by ejection fraction as a continuous measure. Across the range of LVEF, sacubitril/valsartan was associated with a RR 0.54 [95% confidence interval (CI) 0.45-0.65] for the recurrent primary endpoint compared with putative placebo (P < 0.001). Treatment benefits of sacubitril/valsartan vs. putative placebo varied non-linearly with LVEF with attenuation of effects observed at LVEF above 60%. When analyzing data from PARADIGM-HF and CHARM-Alternative, the estimated risk reduction of sacubitril/valsartan vs. putative placebo was 48% (95% CI 35-58%); P < 0.001. When analyzing data from PARAGON-HF and CHARM-Preserved (with LVEF ≥ 45%), the estimated risk reduction of sacubitril/valsartan vs. putative placebo was 29% (95% CI 7-46%); P = 0.013. Across the full range of LVEF, consistent effects were observed for time-to-first endpoints: first primary endpoint (RR 0.72, 95% CI 0.64-0.82), first HF hospitalization (RR 0.67, 95% CI 0.58-0.78), cardiovascular death (RR 0.76, 95% CI 0.64-0.89), and all-cause death (RR 0.83, 95% CI 0.71-0.96); all P < 0.02.
CONCLUSION


This putative placebo analysis reinforces the treatment benefits of sacubitril/valsartan on risk of adverse cardiovascular events across the full range of LVEF, with most pronounced effects observed at a LVEF up to 60%.",2020,"Across the full range of LVEF, consistent effects were observed for time-to-first endpoints: first primary endpoint (RR 0.72, 95% CI 0.64-0.82), first HF hospitalization (RR 0.67, 95% CI 0.58-0.78), cardiovascular death (RR 0.76, 95% CI 0.64-0.89), and all-cause death (RR 0.83, 95% CI 0.71-0.96); all P < 0.02.
CONCLUSION


",['patients with HF with preserved ejection fraction'],"['placebo', 'sacubitril/valsartan vs. putative placebo', 'valsartan against active controls given renin-angiotensin system inhibitors (RASi', 'sacubitril/valsartan', 'sacubitril/valsartan with putative placebos', 'CHARM-Alternative and CHARM-Preserved trials (n\u2009=\u20095050, candesartan vs. placebo']","['heart failure across the full range of ejection fraction', 'Total HF hospitalizations and cardiovascular death', 'HF hospitalization', 'cause death', 'rate ratio (RR', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035096'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.430989,"Across the full range of LVEF, consistent effects were observed for time-to-first endpoints: first primary endpoint (RR 0.72, 95% CI 0.64-0.82), first HF hospitalization (RR 0.67, 95% CI 0.58-0.78), cardiovascular death (RR 0.76, 95% CI 0.64-0.89), and all-cause death (RR 0.83, 95% CI 0.71-0.96); all P < 0.02.
CONCLUSION


","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, 3500 Gaston Avenue, Dallas, TX 75246, USA.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Widimský', 'Affiliation': 'Department of Medicine III, Charles University in Prague, First Faculty of Medicine, Katerinská 32, CZ-121 08 Prague 2, Czech Republic.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Seferovic', 'Affiliation': 'Heart Failure Center, Faculty of Medicine, University of Belgrade, 8 Koste Todorovića, Belgrade 11000, Serbia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Rizkala', 'Affiliation': 'Global Drug Development, Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Global Drug Development, Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Global Drug Development, Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}]",European heart journal,['10.1093/eurheartj/ehaa184']
766,29658750,Emotional arousal may increase susceptibility to fraud in older and younger adults.,"Financial fraud is a societal problem for adults of all ages, but financial losses are especially damaging to older adults who typically live on fixed incomes and have less time to recoup losses. Persuasion tactics used by fraud perpetrators often elicit high levels of emotional arousal; thus, studying emotional arousal may help to identify the conditions under which individuals are particularly susceptible to fraud. We examined whether inducing high-arousal positive (HAP) and high-arousal negative (HAN) emotions increased susceptibility to fraud. Older (ages 65 to 85) and younger (ages 30 to 40) adults were randomly assigned to 1 of 3 emotional arousal conditions in a laboratory task: HAP, HAN, or low arousal (LA). Fraud susceptibility was assessed through participants' responses to misleading advertisements. Both HAP and HAN emotions were successfully induced in older and younger participants. For participants who exhibited the intended induced emotional arousal, both the HAP and HAN conditions, relative to the LA condition, significantly increased participants' reported intention to purchase falsely advertised items. These effects did not differ significantly between older and younger adults and were mitigated in participants who did not exhibit the intended emotional arousal. However, irrespective of the emotional arousal condition to which older adults were assigned (HAP, HAN, or LA), they reported greater purchase intention than did younger adults. These results inform the literature on fraud susceptibility and aging. Educating consumers to postpone financial decisions until they are in calm emotional states may protect against this common persuasion tactic. (PsycINFO Database Record",2018,These effects did not differ significantly between older and younger adults and were mitigated in participants who did not exhibit the intended emotional arousal.,"['older and younger adults', 'Older (ages 65 to 85) and younger (ages 30 to 40) adults', 'older and younger participants']","['3 emotional arousal conditions in a laboratory task: HAP, HAN, or low arousal (LA']","['Emotional arousal', 'high-arousal positive (HAP) and high-arousal negative (HAN) emotions']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0641339', 'cui_str': 'HAN(II)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.0998415,These effects did not differ significantly between older and younger adults and were mitigated in participants who did not exhibit the intended emotional arousal.,"[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kircanski', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Notthoff', 'Affiliation': 'Department of Psychology, Humboldt University Berlin.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'DeLiema', 'Affiliation': 'Stanford Center on Longevity, Stanford University.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Samanez-Larkin', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Shadel', 'Affiliation': 'AARP Washington.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Mottola', 'Affiliation': 'Financial Industry Regulatory Authority (FINRA) Investor Education Foundation.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Carstensen', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Gotlib', 'Affiliation': 'Department of Psychology, Stanford University.'}]",Psychology and aging,['10.1037/pag0000228']
767,29871673,"'Test n Treat (TnT)'- Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial.","BACKGROUND


Sexually active young people attending London further education (FE) colleges have high rates of chlamydia, but screening rates are low. We will conduct a cluster randomised feasibility trial of frequent, rapid, on-site chlamydia testing and same-day treatment (Test and Treat (TnT)) in six FE colleges (with parallel qualitative and economic assessments) to assess the feasibility of conducting a future trial to investigate if TnT reduces chlamydia rates.
METHODS


We will recruit 80 sexually active students aged 16-24 years from public areas at each of six colleges. All participants (total n = 480) will be asked to provide samples (urine for males, self-taken vaginal swabs for females) and complete questionnaires on sexual lifestyle and healthcare use at baseline and after 7 months. Participants will be informed that baseline samples will not be tested for 7 months and be advised to get screened separately. Colleges will be randomly allocated to the intervention (TnT) or the control group (no TnT). One and 4 months after recruitment, participants at each intervention college (n = 3) will be texted and invited for on-site chlamydia tests using the 90-min Cepheid GeneXpert system. Students with positive results will be asked to see a visiting nurse health adviser for same-day treatment and partner notification, (backed by genitourinary medicine follow-up). Participants in control colleges (n = 3) will receive 'thank you' texts 1 and 4 months after recruitment. Seven months after recruitment, participants from both groups will be invited to complete questionnaires and provide samples for TnT. All samples will be tested, and same-day treatment offered to students with positive results. Acceptability of TnT will be assessed by qualitative interviews of purposively sampled students (n = 30) and college staff (n = 12). We will collect data on costs of TnT and usual healthcare.
DISCUSSION


Findings will provide key values to inform feasibility, sample size and timescales of a future definitive trial of TnT in FE colleges, including: Recruitment rates TnT uptake rates Follow-up rates Prevalence of chlamydia in participants at baseline and 7 months Acceptability of TnT to students and college staff Estimate of the cost per person screened/treated in TnT versus usual care TRIAL REGISTRATION: International Standard Randomised Controlled Trials Registry, ID: ISRCTN58038795 , Registered on 31 August 2016.",2018,"BACKGROUND


Sexually active young people attending London further education (FE) colleges have high rates of chlamydia, but screening rates are low.","['sexually active further education college students', 'purposively sampled students (n\u2009=\u200930) and college staff (n\u2009=\u200912', 'All participants (total n\u2009=\u2009480) will be asked to provide samples (urine for males, self-taken vaginal swabs for females) and complete questionnaires on sexual lifestyle and healthcare use at baseline and after 7 months', '80 sexually active students aged 16-24 years from public areas at each of six colleges']","['same-day treatment (Test and Treat (TnT', 'control group (no TnT', ""Test n Treat (TnT)'- Rapid testing and same-day, on-site treatment""]",[],"[{'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0557809', 'cui_str': 'Further education college (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0042037'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0578549', 'cui_str': 'Taking vaginal swab (procedure)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0041070', 'cui_str': '2,4,6-Trinitrotoluene'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],80.0,0.227643,"BACKGROUND


Sexually active young people attending London further education (FE) colleges have high rates of chlamydia, but screening rates are low.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kerry-Barnard', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, SW17ORE, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fleming', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, SW17ORE, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Reid', 'Affiliation': ""Department of Primary Care and Public Health Sciences, King's College London, 4th Floor, Addison House, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': ""Department of Primary Care and Public Health Sciences, King's College London, 4th Floor, Addison House, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Vari M', 'Initials': 'VM', 'LastName': 'Drennan', 'Affiliation': ""Centre for Health and Social Care Research, Kingston University and St George's University of London, London, SW17ORE, UK.""}, {'ForeName': 'Elisabeth J', 'Initials': 'EJ', 'LastName': 'Adams', 'Affiliation': 'Aquarius Population Health Limited, 58a Highgate High Street, London, N6 5HX, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Majewska', 'Affiliation': 'WEM Consultancy Ltd., 96 Tantallon Road, London, SW12 8DH, UK.'}, {'ForeName': 'Anjella', 'Initials': 'A', 'LastName': 'Balendra', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, SW17ORE, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harding-Esch', 'Affiliation': ""Infection and Immunity, St George's, University of London, London, SW17ORE, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cousins', 'Affiliation': ""Infection and Immunity, St George's, University of London, London, SW17ORE, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tariq Sadiq', 'Affiliation': ""Infection and Immunity, St George's, University of London, London, SW17ORE, UK.""}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Oakeshott', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, SW17ORE, UK. oakeshot@sgul.ac.uk.""}]",Trials,['10.1186/s13063-018-2674-8']
768,29177975,Hepatic safety analysis of trabectedin: results of a pharmacokinetic study with trabectedin in patients with hepatic impairment and experience from a phase 3 clinical trial.,"Purpose Trabectedin is metabolized by the liver and has been associated with transient, noncumulative transaminase elevation. Two recent studies further characterize hepatic tolerability with trabectedin therapy: a phase 1 pharmacokinetic study (Study #1004; NCT01273493) in patients with advanced malignancies and hepatic impairment (HI), and a phase 3 study (Study #3007; NCT01343277) of trabectedin vs. dacarbazine in patients with advanced sarcomas and normal hepatic function. Methods In Study #1004, patients received a single 3-h intravenous (IV) infusion of trabectedin: control group, trabectedin 1.3 mg/m 2 ; HI group (baseline total bilirubin >1.5 and ≤3× upper limit of normal [ULN]; AST and ALT ≤2.5× ULN), trabectedin 0.58 or 0.9 mg/m 2 . In Study #3007, the trabectedin group received 1.5 mg/m 2  by 24-h IV infusion every 3 weeks until disease progression or unacceptable toxicity. Results In Study #1004, dose-normalized trabectedin exposure was higher in HI patients (n = 6) versus controls (n = 9) (geometric mean ratios [90% CI] AUC last : 1.97 [1.20; 3.22]). In Study #3007, following trabectedin administration, 90% of patients had elevated ALT (32% grade 3-4) and 84% had elevated AST (17% grade 3-4). Transaminase elevations were transient and noncumulative. Progression-free survival was similar in patients with grade 3-4 hepatotoxicity (n = 109) versus grade 0-2 hepatotoxicity (n = 231) (median [95% CI]: 4.63 [4.01, 5.85] months versus 3.55 [2.73, 4.63] months; P = 0.545, HR = 0.91 [0.68-1.23]). Conclusion Trabectedin treatment of patients with HI results in higher plasma exposures. Hepatotoxicity in patients with normal liver function can be effectively addressed through dose reductions and delays.",2018,"Progression-free survival was similar in patients with grade 3-4 hepatotoxicity (n = 109) versus grade 0-2 hepatotoxicity (n = 231) (median [95% CI]: 4.63 [4.01, 5.85] months versus 3.55 [2.73, 4.63] months; P = 0.545, HR = 0.91 [0.68-1.23]).","['patients with hepatic impairment and experience from a phase 3 clinical trial', 'patients with normal liver function', 'patients with advanced malignancies and hepatic impairment (HI', 'patients with advanced sarcomas and normal hepatic function']","['single 3-h intravenous (IV) infusion of trabectedin: control group, trabectedin 1.3\xa0mg/m 2 ; HI group (baseline total bilirubin >1.5 and ≤3× upper limit of normal [ULN]; AST and ALT ≤2.5× ULN), trabectedin 0.58 or 0.9\xa0mg/m 2 ', 'trabectedin', 'trabectedin vs. dacarbazine', 'trabectedin therapy']","['Transaminase elevations', 'elevated ALT', 'Hepatotoxicity', 'Progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.120689,"Progression-free survival was similar in patients with grade 3-4 hepatotoxicity (n = 109) versus grade 0-2 hepatotoxicity (n = 231) (median [95% CI]: 4.63 [4.01, 5.85] months versus 3.55 [2.73, 4.63] months; P = 0.545, HR = 0.91 [0.68-1.23]).","[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': 'START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain. emiliano.calvo@start.stoh.com.'}, {'ForeName': 'Analia', 'Initials': 'A', 'LastName': 'Azaro', 'Affiliation': ""Molecular Therapeutics Research Unit, Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rodon', 'Affiliation': ""Molecular Therapeutics Research Unit, Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Oncology Center GZA Hospitals Sint Augustinus, Translational Cancer Research Unit, Department of Medical Oncology, Antwerp, Belgium.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Huizing', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Francis Mark', 'Initials': 'FM', 'LastName': 'Senecal', 'Affiliation': 'Hem Onc Northwest PC, Tacoma, WA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'LoRusso', 'Affiliation': 'Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Lorrin', 'Initials': 'L', 'LastName': 'Yee', 'Affiliation': 'Northwest Medical Specialties PLLC, Tacoma, WA, USA.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Poggesi', 'Affiliation': 'Janssen-Cilag SpA, Cologno Monzese, Milan, Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'de Jong', 'Affiliation': 'Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Triantos', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Youn C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Knoblauch', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Trilok V', 'Initials': 'TV', 'LastName': 'Parekh', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Demetri', 'Affiliation': 'Sarcoma Center and Ludwig Center, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",Investigational new drugs,['10.1007/s10637-017-0546-9']
769,29659126,Guanfacine decreases symptoms of cannabis withdrawal in daily cannabis smokers.,"The α2a-adrenergic agonist, lofexidine, reduced cannabis withdrawal-related sleep disruption in the laboratory, but side effects (e.g. fatigue, hypotension) limit its utility as a treatment for cannabis use disorder. This study tested the potential efficacy and tolerability of a daily bedtime administration of the FDA-approved α2a-adrenergic agonist, guanfacine, in a human laboratory model of cannabis use disorder. Daily, nontreatment-seeking cannabis smokers (13M, 2F) completed a within-subject study comprising two 9-day inpatient study phases. Each phase tested the effects of daily placebo or immediate-release guanfacine (2 mg) on cannabis intoxication (5.6 percent THC; 2 days), withdrawal (4 days of abstinence) and subsequent 'relapse' (3 days of cannabis self-administration). Ratings of mood, sleep, cardiovascular effects, food intake, psychomotor performance and cannabis self-administration were assessed. An outpatient phase preceded each inpatient phase for medication clearance or dose induction. Under placebo medication conditions, cannabis abstinence produced significant withdrawal, including irritability, sleep disruption and anorexia. Guanfacine reduced ratings of irritability and improved objective measures of sleep during cannabis withdrawal relative to placebo but did not reduce cannabis self-administration. Guanfacine was well tolerated with little evidence of fatigue and only small decreases in blood pressure: no dose was held due to hypotension. Thus, a single daily administration of guanfacine at bedtime improved sleep and mood during cannabis withdrawal relative to placebo. This positive signal supports further studies varying the guanfacine dose, formulation or frequency of administration, or combining it with other medications to increase the likelihood of having an impact on cannabis use.",2019,Guanfacine reduced ratings of irritability and improved objective measures of sleep during cannabis withdrawal relative to placebo but did not reduce cannabis self-administration.,"['Daily, nontreatment-seeking cannabis smokers (13M, 2F) completed a within-subject study comprising two 9-day inpatient study phases', 'daily cannabis smokers']","['lofexidine', 'placebo', 'placebo or immediate-release guanfacine', 'Guanfacine', 'guanfacine', 'FDA-approved α2a-adrenergic agonist, guanfacine']","['blood pressure', 'irritability, sleep disruption and anorexia', 'cannabis intoxication', 'potential efficacy and tolerability', 'ratings of irritability', 'sleep and mood', 'Ratings of mood, sleep, cardiovascular effects, food intake, psychomotor performance and cannabis self-administration']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0065152', 'cui_str': 'lofexidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0001648', 'cui_str': 'Adrenomimetics'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0006872', 'cui_str': 'Cannabis sativa poisoning (disorder)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0036589', 'cui_str': 'Self Administration'}]",,0.277342,Guanfacine reduced ratings of irritability and improved objective measures of sleep during cannabis withdrawal relative to placebo but did not reduce cannabis self-administration.,"[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Haney', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Ziva D', 'Initials': 'ZD', 'LastName': 'Cooper', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Gillinder', 'Initials': 'G', 'LastName': 'Bedi', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Herrmann', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Stephanie Collins', 'Initials': 'SC', 'LastName': 'Reed', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Foltin', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}]",Addiction biology,['10.1111/adb.12621']
770,29652246,Metformin in non-diabetic hyperglycaemia: the GLINT feasibility RCT.,"BACKGROUND


The treatment of people with diabetes with metformin can reduce cardiovascular disease (CVD) and may reduce the risk of cancer. However, it is unknown whether or not metformin can reduce the risk of these outcomes in people with elevated blood glucose levels below the threshold for diabetes [i.e. non-diabetic hyperglycaemia (NDH)].
OBJECTIVE


To assess the feasibility of the Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT) and to estimate the key parameters to inform the design of the full trial. These parameters include the recruitment strategy, randomisation, electronic data capture, postal drug distribution, retention, study medication adherence, safety monitoring and remote collection of outcome data.
DESIGN


A multicentre, individually randomised, double-blind, parallel-group, pragmatic, primary prevention trial. Participants were individually randomised on a 1 : 1 basis, blocked within each site.
SETTING


General practices and clinical research facilities in Cambridgeshire, Norfolk and Leicestershire.
PARTICIPANTS


Males and females aged ≥ 40 years with NDH who had a high risk of CVD.
INTERVENTIONS


Prolonged-release metformin (500 mg) (Glucophage ®  SR, Merck KGaA, Bedfont Cross, Middlesex, UK) or the matched placebo, up to three tablets per day, distributed by post.
MAIN OUTCOME MEASURES


Recruitment rates; adherence to study medication; laboratory results at baseline and 3 and 6 months; reliability and acceptability of study drug delivery; questionnaire return rates; and quality of life.
RESULTS


We sent 5251 invitations, with 511 individuals consenting to participate. Of these, 249 were eligible and were randomised between March and November 2015 (125 to the metformin group and 124 to the placebo group). Participants were followed up for 0.99 years [standard deviation (SD) 0.30 years]. The use of electronic medical records to identify potentially eligible individuals in individual practices was resource intensive. Participants were generally elderly [mean age 70 years (SD 6.7 years)], overweight [mean body mass index 30.1 kg/m 2  (SD 4.5 kg/m 2 )] and male (88%), and the mean modelled 10-year CVD risk was 28.8% (SD 8.5%). Randomisation, postal delivery of the study drug and outcome assessment using registers/medical records were feasible and acceptable to participants. Most participants were able to take three tablets per day, but premature discontinuation of the study drug was common (≈30% of participants by 6 months), although there were no differences between the groups. All randomised participants returned questionnaires at baseline and 67% of participants returned questionnaires by the end of the study. There was no between-group difference in Short Form questionnaire-8 items or EuroQol-5 Dimensions scores. Compared with placebo, metformin was associated with small improvements in the mean glycated haemoglobin level [-0.82 mmol/mol, 95% confidence interval (CI) -1.39 to -0.24 mmol/mol], mean estimated glomerular filtration rate (2.31 ml/minute/1.73 m 2 , 95% CI -0.2 to 4.81 ml/minute/1.73 m 2 ) and mean low-density lipoprotein cholesterol level (-0.11 mmol/l, 95% CI -0.25 to 0.02 mmol/l) and a reduction in mean plasma vitamin B 12  level (-16.4 ng/l, 95% CI -32.9 to -0.01 ng/l). There were 35 serious adverse events (13 in the placebo group, 22 in the metformin group), with none deemed to be treatment related.
LIMITATIONS


Changes to sponsorship reduced the study duration, the limited availability of information in medical records reduced recruitment efficiency and discontinuation of study medication exceeded forecasts.
CONCLUSIONS


A large, pragmatic trial comparing the effects of prolonged-release metformin and placebo on the risk of CVD events is potentially feasible. However, changes to the study design and conduct are recommended to enable an efficient scaling up of the trial. Recommendations include changing the inclusion criteria to recruit people with pre-existing CVD to increase the recruitment and event rates, using large primary/secondary care databases to increase recruitment rates, conducting follow-up remotely to improve efficiency and including a run-in period prior to randomisation to optimise trial adherence.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN34875079.
FUNDING


The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 22, No. 18. See the NIHR Journals Library website for further project information. Merck KGaA provided metformin and matching placebo.",2018,"Compared with placebo, metformin was associated with small improvements in the mean glycated haemoglobin level [-0.82 mmol/mol, 95% confidence interval (CI) -1.39 to -0.24 mmol/mol], mean estimated glomerular filtration rate (2.31 ml/minute/1.73 ","['people with diabetes with', 'non-diabetic hyperglycaemia', '249 were eligible and were randomised between March and November 2015 (125 to the metformin group and 124 to the', 'Participants were generally elderly [mean age 70 years (SD 6.7 years)], overweight [mean body mass index 30.1\u2009kg/m 2  (SD 4.5\u2009kg/m 2 )] and male (88%), and the mean modelled 10-year CVD risk was 28.8% (SD 8.5', 'General practices and clinical research facilities in Cambridgeshire, Norfolk and Leicestershire', 'Males and females aged ≥\u200940 years with NDH who had a high risk of CVD', '511 individuals consenting to participate']","['placebo, metformin', 'placebo', 'metformin', 'metformin and matching placebo', 'prolonged-release metformin and placebo', 'Prolonged-release metformin', 'Metformin']","['mean low-density lipoprotein cholesterol level', 'mean glycated haemoglobin level', 'Recruitment rates; adherence to study medication; laboratory results at baseline and 3 and 6 months; reliability and acceptability of study drug delivery; questionnaire return rates; and quality of life', 'mean plasma vitamin B 12  level', 'Short Form questionnaire-8 items or EuroQol-5 Dimensions scores', 'glomerular filtration rate', 'serious adverse events', 'recruitment strategy, randomisation, electronic data capture, postal drug distribution, retention, study medication adherence, safety monitoring and remote collection of outcome data']","[{'cui': 'C0850671', 'cui_str': 'Non-diabetic hyperglycemia'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0454843', 'cui_str': 'Cambridgeshire (geographic location)'}, {'cui': 'C0454866', 'cui_str': 'Norfolk (geographic location)'}, {'cui': 'C0454863', 'cui_str': 'Leicestershire (geographic location)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",5251.0,0.364326,"Compared with placebo, metformin was associated with small improvements in the mean glycated haemoglobin level [-0.82 mmol/mol, 95% confidence interval (CI) -1.39 to -0.24 mmol/mol], mean estimated glomerular filtration rate (2.31 ml/minute/1.73 ","[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Wareham', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Brierley', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dymond', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Eichenberger', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Evans', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Kyla', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hitman', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Irving', 'Affiliation': 'Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lessels', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Millward', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Petrie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rutter', 'Affiliation': 'Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sharp', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta22180']
771,31586293,Enhancing the efficacy of  131 I therapy in non-toxic multinodular goitre with appropriate use of methimazole: an analysis of randomized controlled study.,"PURPOSE


It is possible to raise the rate of the uptake of  131 I in the thyroid gland (RAIU) by increasing the endogenous TSH level through appropriate use of methimazole (MMI) prior to  131 I therapy. The purpose of this paper is to assess the impact of pre treatment with MMI on the efficacy of  131 I therapy in non-toxic multinodular goitre (NMG).
METHODS


Thirty-one patients with NMG received  131 I treatment in order to reduce the volume of the thyroid (TVR). Those in group 1 (n = 16) were administered 10 mg of methimazole for 6 weeks. Four days after its discontinuation, they received  131 I. Patients in group 2 (n = 15) were given a placebo instead of MMI. The therapeutic activity of  131 I was constant (800 MBq) and was repeated every 6 months. Treatment was discontinued when TVR reached <40 ml.
RESULTS


In group 1, RAIU increased approximately twofold. Ten patients from group 2 and four patients from group 1 received further doses of  131 I. The median of time until TVR decreased below 40 ml was 9 months [6-12 months] and 18 months [14-22 months] in group 2. At 2 years after the  131 I therapy, the occurrence of hypothyroidism did not differ significantly (36% in group 1 and 33% in group2, p = 0.074).
CONCLUSIONS


Radioiodine treatment of NMG preceded with appropriate application of MMI is efficient thanks to increased RAIU, shorter period of treatment, and lower frequency of  131 I administration, without an increase in the incidence of post-treatment hypothyroidism.",2020,"At 2 years after the  131 I therapy, the occurrence of hypothyroidism did not differ significantly (36% in group 1 and 33% in group2, p = 0.074).
",['Thirty-one patients with NMG received  131'],"['placebo instead of MMI', 'MMI', 'methimazole (MMI', 'methimazole']","['occurrence of hypothyroidism', 'median of time until TVR', 'volume of the thyroid (TVR', 'RAIU']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025644', 'cui_str': 'thiamazole'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}]",131.0,0.0255241,"At 2 years after the  131 I therapy, the occurrence of hypothyroidism did not differ significantly (36% in group 1 and 33% in group2, p = 0.074).
","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Szumowski', 'Affiliation': 'Department of Nuclear Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland. piotrmjs@wp.pl.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Abdelrazek', 'Affiliation': 'Department of Nuclear Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sykała', 'Affiliation': 'Department of Nuclear Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Mojsak', 'Affiliation': 'Department of Nuclear Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Żukowski', 'Affiliation': 'Department of Nuclear Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Siewko', 'Affiliation': 'Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Maliszewska', 'Affiliation': 'Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Adamska', 'Affiliation': 'Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Popławska-Kita', 'Affiliation': 'Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Krętowski', 'Affiliation': 'Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Myśliwiec', 'Affiliation': 'Department of Nuclear Medicine, Medical University of Bialystok, M. Skłodowskiej-Curie St. 24A, 15-276, Bialystok, Poland.'}]",Endocrine,['10.1007/s12020-019-02100-x']
772,31831388,"Endovascular treatment versus standard medical treatment for vertebrobasilar artery occlusion (BEST): an open-label, randomised controlled trial.","BACKGROUND


Previous randomised trials have shown an overwhelming benefit of mechanical thrombectomy for treating patients with stroke caused by large vessel occlusion of the anterior circulation. Whether endovascular treatment is beneficial for vertebrobasilar artery occlusion remains unknown. In this study, we aimed to investigate the safety and efficacy of endovascular treatment of acute strokes due to vertebrobasilar artery occlusion.
METHODS


We did a multicentre, randomised, open-label trial, with blinded outcome assessment of thrombectomy in patients presenting within 8 h of vertebrobasilar occlusion at 28 centres in China. Patients were randomly assigned (1:1) to endovascular therapy plus standard medical therapy (intervention group) or standard medical therapy alone (control group). The randomisation sequence was computer-generated and stratified by participating centres. Allocation concealment was implemented by use of sealed envelopes. The primary outcome was a modified Rankin scale (mRS) score of 3 or lower (indicating ability to walk unassisted) at 90 days, assessed on an intention-to-treat basis. The primary safety outcome was mortality at 90 days. Secondary safety endpoints included the rates of symptomatic intracranial haemorrhage, device-related complications, and other severe adverse events. The BEST trial is registered with ClinicalTrials.gov, NCT02441556.
FINDINGS


Between April 27, 2015, and Sept 27, 2017, we assessed 288 patients for eligibility. The trial was terminated early after 131 patients had been randomly assigned (66 patients to the intervention group and 65 to the control group) because of high crossover rate and poor recruitment. In the intention-to-treat analysis, there was no evidence of a difference in the proportion of participants with mRS 0-3 at 90 days according to treatment (28 [42%] of 66 patients in the intervention group vs 21 [32%] of 65 in the control group; adjusted odds ratio [OR] 1·74, 95% CI 0·81-3·74). Secondary prespecified analyses of the primary outcome, done to assess the effect of crossovers, showed higher rates of mRS 0-3 at 90 days in patients who actually received the intervention compared with those who received standard medical therapy alone in both per-protocol (28 [44%] of 63 patients with intervention vs 13 [25%] of 51 with standard therapy; adjusted OR 2·90, 95% CI 1·20-7·03) and as-treated (36 [47%] of 77 patients with intervention vs 13 [24%] of 54 with standard therapy; 3·02, 1·31-7·00) populations. The 90-day mortality was similar between groups (22 [33%] of 66 patients in the intervention vs 25 [38%] of 65 in the control group; p=0·54) despite a numerically higher prevalence of symptomatic intracranial haemorrhage in the intervention group.
INTERPRETATION


There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone. Results might have been confounded by loss of equipoise over the course of the trial, resulting in poor adherence to the assigned study treatment and a reduced sample size due to the early termination of the study.
FUNDING


Jiangsu Provincial Special Program of Medical Science.",2020,There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone.,"['vertebrobasilar artery occlusion (BEST', 'Between April 27, 2015, and Sept 27, 2017, we assessed 288 patients for eligibility', 'patients presenting within 8 h of vertebrobasilar occlusion at 28 centres in China', '131 patients', 'patients with stroke caused by large vessel occlusion of the anterior circulation']","['endovascular therapy', 'endovascular treatment', 'endovascular therapy plus standard medical therapy (intervention group) or standard medical therapy alone (control group', 'Endovascular treatment versus standard medical treatment']","['modified Rankin scale (mRS) score of 3 or lower (indicating ability to walk unassisted) at 90 days, assessed on an intention-to-treat basis', 'mortality', 'symptomatic intracranial haemorrhage', 'safety and efficacy', 'rates of symptomatic intracranial haemorrhage, device-related complications, and other severe adverse events', '90-day mortality']","[{'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",288.0,0.210128,There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone.,"[{'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China; Stroke Center and Department of Neurology, First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China. Electronic address: xfliu2@ustc.edu.cn.'}, {'ForeName': 'Qiliang', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Ruidong', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Zi', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China; Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Statistics, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Huaiming', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wusheng', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Qiushi', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': ""Department of Neurosurgery, 101th Hospital of the People's Liberation Army, Wuxi, China.""}, {'ForeName': 'Dequan', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurology, 175th hospital of the People's Liberation Army, Affiliated Southeast Hospital of Xiamen University, Zhangzhou, China.""}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Neurology, Hubei Zhongshan Hospital, Hubei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Neurology, Hubei Zhongshan Hospital, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Changsha Central Hospital, Changsha, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, Hangzhou, China.""}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Affiliated Zhongshan Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Liao', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': ""Department of Neurology, Lu'an Affiliated Hospital of Anhui Medical University, Lu'an, China.""}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Guangdong No 2 Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hongchao', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Sichuan People's Hospital, Chengdu, China.""}, {'ForeName': 'Congguo', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, First People's Hospital of Huainan, Huainan, China.""}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, Lishui Hospital of Zhejiang University, Lishui, China.'}, {'ForeName': 'Qiyi', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Neurology, Linyi People's Hospital, Linyi, China.""}, {'ForeName': 'Zhonglun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, Taian City Central Hospital, Taian, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Fuzhou General Hospital of Nanjing Military Region, Fuzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Haowen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Intervention Neuroradiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Wuhan No 1 Hospital, Wuhan, China.'}, {'ForeName': 'Xiguang', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, Chinese Armed Police Force Guangdong Armed Police Corps hospital, Guangzhou, China.'}, {'ForeName': 'Zili', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Haicun', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Third People's Hospital of Yancheng, Yancheng, China.""}, {'ForeName': 'Chuanming', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Shenzhen Nanshan People's Hospital and 6th Affiliated Hospital of Shenzhen University Health Science Center, Shenzhen, China.""}, {'ForeName': 'Penghua', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': ""Department of Interventional Radiology, Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Liangfu', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Cerebrovascular Center, Henan Provincial People's Hospital, Zhengzhou University, Zhengzhou, China.""}, {'ForeName': 'Shiquan', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, 123rd Hospital of the People's Liberation Army, Bengbu, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Stroke Center and Department of Neurology, First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Pingzhou', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Yangzhou Hongquan Hospital, Yangzhou, China.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Neurovascular Imaging Research Core and University of California Los Angeles Stroke Center, Department of Neurology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Vitor M', 'Initials': 'VM', 'LastName': 'Pereira', 'Affiliation': 'Department of Medical Imaging and Surgery, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Gelin', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Department of Neurology, Neurosurgery and Radiology, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: rnoguei@emory.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30395-3']
773,31976567,Long-term outcomes of osteotome sinus floor elevation with or without bone grafting: The 10-year results of a randomized controlled trial.,"AIMS


To assess the long-term clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with or without bone grafting.
MATERIALS AND METHODS


Forty-five patients were randomly assigned into two groups: Group 1 (OSFE with deproteinized bovine bone mineral) and Group 2 (OSFE without grafting). The patients were recalled at 1, 3, 5 and 10 years after surgery. The implant survival, endo-sinus bone gain (ESBG), marginal bone loss (MBL), peri-implant bone height (PBH, distance from the most coronal level to the most apical level of bone-to-implant contact), prosthesis survival and hardware complications, and peri-implant soft tissue conditions were assessed.
RESULTS


Forty patients attended the 10-year examination. Mean residual bone height was 4.58 ± 1.28 mm. The 10-year cumulative survival rate was 90.7% for Group 1 and 95.0% for Group 2. The PBH was 5.89 ± 1.24 mm for Group 1 and 5.74 ± 1.43 mm for Group 2 at 10 years. The ESBG of both groups remained stable after 3 years. Two-thirds of the implants were free of hardware complications. No significant differences in MBL and peri-implant tissue parameters were found.
CONCLUSION


OSFE with or without grafting both yielded predictable clinical outcomes with similar PBH (ClinicalTrials.gov. NCT01619956).",2020,The 10-year cumulative survival rate was 90.7% for Group 1 and 95.0% for Group 2.,"['Forty patients attended the 10-year examination', 'Forty-five patients']","['osteotome sinus floor elevation with or without bone grafting', 'Group 1 (OSFE with deproteinized bovine bone mineral) and Group 2 (OSFE without grafting', 'implants placed using osteotome sinus floor elevation (OSFE) with or without bone grafting']","['implant survival, endo-sinus bone gain (ESBG), marginal bone loss (MBL), peri-implant bone height (PBH, distance from the most coronal level to the most apical level of bone-to-implant contact), prosthesis survival and hardware complications, and peri-implant soft tissue conditions', 'hardware complications', 'MBL and peri-implant tissue parameters', 'Mean residual bone height', '10-year cumulative survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0182092', 'cui_str': 'Osteotome (physical object)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C3179277', 'cui_str': 'Prosthesis Survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}]",45.0,0.064398,The 10-year cumulative survival rate was 90.7% for Group 1 and 95.0% for Group 2.,"[{'ForeName': 'Shu-Jiao', 'Initials': 'SJ', 'LastName': 'Qian', 'Affiliation': ""Department of Implant Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institue of Stomatology, Shanghai, China.""}, {'ForeName': 'Jia-Ji', 'Initials': 'JJ', 'LastName': 'Mo', 'Affiliation': ""Department of Implant Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institue of Stomatology, Shanghai, China.""}, {'ForeName': 'Mi-Si', 'Initials': 'MS', 'LastName': 'Si', 'Affiliation': 'Department of Oral Implantology, Stomatology Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shi-Chong', 'Initials': 'SC', 'LastName': 'Qiao', 'Affiliation': ""Department of Implant Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institue of Stomatology, Shanghai, China.""}, {'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Shi', 'Affiliation': ""Department of Implant Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institue of Stomatology, Shanghai, China.""}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': ""Department of Implant Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institue of Stomatology, Shanghai, China.""}]",Journal of clinical periodontology,['10.1111/jcpe.13260']
774,31970906,Appetite-Related Responses to Overfeeding and Longitudinal Weight Change in Obesity-Prone and Obesity-Resistant Adults.,"OBJECTIVE


Appetite responses to 3 days of overfeeding (OF) were examined as correlates of longitudinal weight change in adults classified as obesity prone (OP) or obesity resistant (OR).
METHODS


OP (n = 22) and OR (n = 30) adults consumed a controlled eucaloric and OF diet (140% of energy needs) for 3 days, followed by 3 days of ad libitum feeding. Hunger and satiety were evaluated by visual analog scales. Ghrelin and peptide YY (PYY) levels were measured during a 24-hour inpatient visit on day 3. Body weight and composition were measured annually for 4.0 ± 1.3 years.
RESULTS


Dietary restraint and disinhibition were greater in OP than OR (mean difference: 3.5 ± 1.2 and 3.3 ± 0.9, respectively; P < 0.01) participants, and disinhibition was associated with longitudinal weight change (n = 48; r = 0.35; P = 0.02). Compared with the eucaloric diet, energy intake fell significantly in OR participants following OF (P = 0.03) but not in OP (P = 0.33) participants. Twenty-four-hour PYY area under the curve values increased with OF in OR (P = 0.02) but not in OP (P = 0.17) participants. Furthermore, changes in PYY levels with OF correlated with measured energy intake (r = -0.36; P = 0.01).
CONCLUSIONS


Baseline disinhibition and PYY responses to OF differed between OP and OR adults. Dietary disinhibition was associated with 5-year longitudinal weight gain. Differences in appetite regulation may underlie differences in propensity for weight gain.",2020,Twenty-four-hour PYY area under the curve values increased with OF in OR (P = 0.02) but not in OP (P = 0.17) participants.,"['adults classified as obesity prone (OP) or obesity resistant (OR', 'Obesity-Prone and Obesity-Resistant Adults', 'OP (n\u2009=\u200922) and OR (n\u2009=\u200930) adults']",['consumed a controlled eucaloric and OF diet'],"['Hunger and satiety', 'Ghrelin and peptide YY (PYY) levels', 'visual analog scales', 'Dietary disinhibition', 'Body weight and composition', 'energy intake fell', '5-year longitudinal weight gain', 'longitudinal weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition, function (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",,0.100239,Twenty-four-hour PYY area under the curve values increased with OF in OR (P = 0.02) but not in OP (P = 0.17) participants.,"[{'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Rynders', 'Affiliation': ""Center for Women's Health Research, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bergouignan', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Kealey', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22687']
775,31981517,Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study.,"BACKGROUND


Colonoscopy with computer-aided detection (CADe) has been shown in non-blinded trials to improve detection of colon polyps and adenomas by providing visual alarms during the procedure. We aimed to assess the effectiveness of a CADe system that avoids potential operational bias.
METHODS


We did a double-blind randomised trial at the endoscopy centre in Caotang branch hospital of Sichuan Provincial People's Hospital in China. We enrolled consecutive patients (aged 18-75 years) presenting for diagnostic and screening colonoscopy. We excluded patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery or who had a contraindication for biopsy; we also excluded patients who had previously had an unsuccessful colonoscopy and who had a high suspicion for polyposis syndromes, inflammatory bowel disease, and colorectal cancer. We allocated patients (1:1) to colonoscopy with either the CADe system or a sham system. Randomisation was by computer-generated random number allocation. Patients and the endoscopist were unaware of the random assignment. To achieve masking, the output of the system was shown on a second monitor that was only visible to an observer who was responsible for reporting the alerts. The primary outcome was the adenoma detection rate (ADR), which is the proportion of individuals having a complete colonoscopy, from caecum to rectum, who had one or more adenomas detected. The primary analysis was per protocol. We also analysed characteristics of polyps and adenomas missed initially by endoscopists but detected by the CADe system. This trial is complete and is registered with http://www.chictr.org.cn, ChiCTR1800017675.
FINDINGS


Between Sept 3, 2018, and Jan 11, 2019, 1046 patients were enrolled to the study, of whom 36 were excluded before randomisation, 508 were allocated colonoscopy with polyp detection using the CADe system, and 502 were allocated colonoscopy with the sham system. After further excluding patients who met exclusion criteria, 484 patients in the CADe group and 478 in the sham group were included in analyses. The ADR was significantly greater in the CADe group than in the sham group, with 165 (34%) of 484 patients allocated to the CADe system having one or more adenomas detected versus 132 (28%) of 478 allocated to the sham system (odds ratio 1·36, 95% CI 1·03-1·79; p=0·030). No complications were reported among all colonoscopy procedures. Polyps initially missed by the endoscopist but identified by the CADe system were generally small in size, isochromatic, flat in shape, had an unclear boundary, were partly behind colon folds, and were on the edge of the visual field.
INTERPRETATION


Polyps initially missed by the endoscopist had characteristics that are sometimes difficult for skilled endoscopists to recognise. Such polyps could be detected using a high-performance CADe system during colonoscopy. The effect of CADe during colonoscopy on the incidence of interval colorectal cancer should be investigated.
FUNDING


None.",2020,"Polyps initially missed by the endoscopist but identified by the CADe system were generally small in size, isochromatic, flat in shape, had an unclear boundary, were partly behind colon folds, and were on the edge of the visual field.
","[""Caotang branch hospital of Sichuan Provincial People's Hospital in China"", 'adenoma detection during colonoscopy (CADe-DB trial', 'enrolled consecutive patients (aged 18-75 years) presenting for diagnostic and screening colonoscopy', 'Between Sept 3, 2018, and Jan 11, 2019, 1046 patients were enrolled to the study, of whom 36 were excluded before randomisation, 508 were allocated colonoscopy with polyp detection using the CADe system, and 502 were allocated colonoscopy with the sham system', 'patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery or who had a contraindication for biopsy; we also excluded patients who had previously had an unsuccessful colonoscopy and who had a high suspicion for polyposis syndromes, inflammatory bowel disease, and colorectal cancer']","['CADe', 'endoscopy centre', 'Colonoscopy with computer-aided detection (CADe', 'colonoscopy with either the CADe system or a sham system', 'deep-learning computer-aided detection system']","['incidence of interval colorectal cancer', 'adenoma detection rate (ADR), which is the proportion of individuals having a complete colonoscopy, from caecum to rectum', 'ADR']","[{'cui': 'C0020024', 'cui_str': 'Hospitals, Branch'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0330157', 'cui_str': 'Juniperus oxycedrus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3662621', 'cui_str': 'History of inflammatory bowel disease'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}]","[{'cui': 'C0330157', 'cui_str': 'Juniperus oxycedrus'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}]",1046.0,0.323385,"Polyps initially missed by the endoscopist but identified by the CADe system were generally small in size, isochromatic, flat in shape, had an unclear boundary, were partly behind colon folds, and were on the edge of the visual field.
","[{'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Berzin', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Glissen Brown', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Peixi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Liangping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China. Electronic address: zhou.guanyu@outlook.com.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30411-X']
776,31644514,Glottic visibility for laryngeal surgery: Tritube vs. microlaryngeal tube: A randomised controlled trial.,"BACKGROUND


Good visibility is essential for successful laryngeal surgery. A Tritube with outer diameter 4.4 mm, combined with flow-controlled ventilation (FCV), enables ventilation by active expiration with a sealed trachea and may improve laryngeal visibility.
OBJECTIVES


We hypothesised that a Tritube with FCV would provide better laryngeal visibility and surgical conditions for laryngeal surgery than a conventional microlaryngeal tube (MLT) with volume-controlled ventilation (VCV).
DESIGN


Randomised, controlled trial.
SETTING


University Medical Centre.
PATIENTS


A total of 55 consecutive patients (>18 years) undergoing elective laryngeal surgery were assessed for participation, providing 40 evaluable data sets with 20 per group.
INTERVENTIONS


Random allocation to intubation with Tritube and ventilation with FCV (Tritube-FCV group) or intubation with MLT 6.0 and ventilation with VCV (MLT-VCV) as control. Tidal volumes of 7 ml kg predicted body weight, and positive end-expiratory pressure of 7 cmH2O were standardised between groups.
MAIN OUTCOME MEASURES


Primary endpoint was the tube-related concealment of laryngeal structures, measured on videolaryngoscopic photographs by appropriate software. Secondary endpoints were surgical conditions (categorical four-point rating scale), respiratory variables and change of end-expiratory lung volume from atmospheric airway pressure to ventilation with positive end-expiratory pressure. Data are presented as median [IQR].
RESULTS


There was less concealment of laryngeal structures with the Tritube than with the MLT; 7 [6 to 9] vs. 22 [18 to 27] %, (P < 0.001). Surgical conditions were rated comparably (P = 0.06). A subgroup of residents in training perceived surgical conditions to be better with the Tritube compared with the MLT (P = 0.006). Respiratory system compliance with the Tritube was higher at 61 [52 to 71] vs. 46 [41 to 51] ml cmH2O (P < 0.001), plateau pressure was lower at 14 [13 to 15] vs. 17 [16 to 18] cmH2O (P < 0.001), and change of end-expiratory lung volume was higher at 681 [463 to 849] vs. 414 [194 to 604] ml, (P = 0.023) for Tritube-FCV compared with MLT-VCV.
CONCLUSION


During laryngeal surgery a Tritube improves visibility of the surgical site but not surgical conditions when compared with a MLT 6.0. FCV improves lung aeration and respiratory system compliance compared with VCV.
TRIAL REGISTRY NUMBER


DRKS00013097.",2019,During laryngeal surgery a Tritube improves visibility of the surgical site but not surgical conditions when compared with a MLT 6.0.,"['55 consecutive patients (>18 years) undergoing elective laryngeal surgery were assessed for participation, providing 40 evaluable data sets with 20 per group', 'laryngeal surgery', 'University Medical Centre']","['conventional microlaryngeal tube (MLT) with volume-controlled ventilation (VCV', 'Tritube® vs. microlaryngeal tube', 'cmH2O', 'FCV', 'combined with flow-controlled ventilation (FCV', 'Random allocation to intubation with Tritube and ventilation with FCV (Tritube-FCV group) or intubation with MLT 6.0 and ventilation with VCV (MLT-VCV']","['concealment of laryngeal structures', 'Respiratory system compliance', 'plateau pressure', 'change of end-expiratory lung volume', 'laryngeal visibility and surgical conditions', 'surgical conditions (categorical four-point rating scale), respiratory variables and change of end-expiratory lung volume from atmospheric airway pressure to ventilation with positive end-expiratory pressure', 'visibility of the surgical site', 'tube-related concealment of laryngeal structures, measured on videolaryngoscopic photographs by appropriate software', 'lung aeration and respiratory system compliance', 'Glottic visibility', 'Tidal volumes of 7\u200aml\u200akg predicted body weight, and positive end-expiratory pressure of 7\u200acmH2O']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0015763', 'cui_str': 'Calicivirus, Feline'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C3541375', 'cui_str': 'RESPIRATORY SYSTEM'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}]",55.0,0.107937,During laryngeal surgery a Tritube improves visibility of the surgical site but not surgical conditions when compared with a MLT 6.0.,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'From the Department of Anaesthesiology and Critical Care (JS, FG, JW, VK, CW, SB, SW, SS) and Department of Otorhinolaryngology (JP, CB), Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Günther', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Kehm', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Pfeiffer', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Wenzel', 'Affiliation': ''}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Borgmann', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wirth', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001110']
777,30849239,High dose Nitrate ingestion does not improve 40 km cycling time trial performance in trained cyclists.,"This study evaluated the chronic effects of nitrate (NO 3 - ) ingestion over three days, on 40 km TT performance in 11trained cyclists (VO 2max : 60.8 ± 7.4 ml.kg -1 .min -1 ; age: 36 ± 9 years; height: 1.80 ± 0.06 m; body mass: 87.2 ± 12.0 kg). Utilising a double-blind randomised cross-over design, participants completed three 40 km TT on a Velotron® ergometer following the ingestion of either a 140 ml of ""BEET It sport®"" NO 3 -  shot containing 12.8 mmol or 800 mg of NO 3 - , a placebo drink or nothing (control). Performance, oxygen consumption (VO 2 ), blood bicarbonate (HCO3-), pH and lactate (BLa) and ratings of perceived exertion (RPE) were measured every 10 km throughout the TT. The present findings show that NO 3 -  ingestion had no effect on TT performance (NO 3 - : 4098.0 ± 209.8 vs. Placebo: 4161.9 ± 263.3 s, p = 0.296, ES = 0.11), or VO 2  (p = 0.253, ES = 0.13). Similarly, blood lactate and RPE were also unaffected by the experimental conditions (p = 0.522, ES = 0.06; p = 0.085, ES = 0.30) respectively. Therefore, these results suggest that a high dose of NO 3 -  over three days has limited efficacy as an ergogenic aid for 40 km TT cycling performance in trained cyclists.",2020,"Similarly, blood lactate and RPE were also unaffected by the experimental conditions (p = 0.522, ES = 0.06; p = 0.085, ES = 0.30) respectively.","['trained cyclists', '11trained cyclists (VO 2max : 60.8 ± 7.4 ml.kg -1', '1 ; age: 36 ± 9 years; height: 1.80 ± 0.06 m; body mass: 87.2 ± 12.0 kg']","['placebo drink or nothing (control', 'nitrate (NO 3 - ) ingestion', 'High dose Nitrate ingestion', 'Placebo', 'Velotron® ergometer following the ingestion of either a 140 ml of ""BEET']","['Performance, oxygen consumption (VO 2 ), blood bicarbonate (HCO3-), pH and lactate (BLa) and ratings of perceived exertion (RPE', 'blood lactate and RPE', 'TT performance', '40 km cycling time trial performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517412', 'cui_str': 'Zero point zero six'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0600054', 'cui_str': 'Beets'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0005768'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.477301,"Similarly, blood lactate and RPE were also unaffected by the experimental conditions (p = 0.522, ES = 0.06; p = 0.085, ES = 0.30) respectively.","[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Mosher', 'Affiliation': 'Sports Performance and Nutrition Group, Edge Hill University, Ormskirk, UK.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Gough', 'Affiliation': 'School of Health Sciences, Birmingham City University, Birmingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': 'Department of Life Science, Westminster University, London, United Kingdom.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Mc Naughton', 'Affiliation': 'Sports Performance and Nutrition Group, Edge Hill University, Ormskirk, UK.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Sports Performance and Nutrition Group, Edge Hill University, Ormskirk, UK.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Sparks', 'Affiliation': 'Sports Performance and Nutrition Group, Edge Hill University, Ormskirk, UK.'}]",Research in sports medicine (Print),['10.1080/15438627.2019.1586707']
778,31314952,Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain.,"BACKGROUND


Intramuscular injection of Nerve Growth Factor (NGF) may influence the responsiveness of active chemo-sensitive channels affecting muscle pain sensitivity. This double-blinded crossover study in healthy humans assessed contraction-evoked pain responses and pain sensitivity during acute ischaemia in the tibialis anterior (TA) muscle before and 24 hr after five distributed NGF injections (1 µg, 4 cm interval) compared with control injections (isotonic-saline).
METHODS


Twenty-one subjects participated in two experimental phases, each including five sessions over 7 days, with a gap of 4 weeks in-between. Muscle pain intensity evoked with daily functional tasks (Likert scale score) was collected using a paper diary. Pain intensity evoked by ischaemic and non-ischaemic contractions numerical rating scale (NRS) was collected at Day0 and Day1. Pressure pain thresholds (PPTs) on the TA were recorded before (Day0), 3 hr, 1, 3, and 7 days post-injection, and after the ischaemic-contractions and post-cuff deflation at Day0 and Day1.
RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05). Higher NRS pain scores of ischaemic-contractions were seen when contracting the muscle injected with NGF compared to baseline (p = .003) and control (p = .012). Pain during non-ischaemic contractions was not significantly affected by NGF injections. Decreased PPTs were found at 3 hr, Day1 and Day3 post-injection (p < .05) in both conditions. Compared with pre-contractions, PPTs were increased following ischaemic contractions at Day0 (p < .05) and Day1 (p < .05) in both conditions.
CONCLUSION


This study showed that ischaemic contraction-evoked pain was facilitated in an NGF-sensitized muscle.
SIGNIFICANCE


Acidification of the muscle environment may affect muscle nociceptors and pain by different mechanisms, including activation of ASIC 3  and TRPV1. In this study, pain evoked following ischaemic contractions was increased in the Nerve Growth Factor (NGF)-sensitized muscle compared with non-ischaemic contractions and in the non-sensitized muscle. These findings illustrate that responses of peripheral afferents under ischaemic conditions are altered by a pre-sensitized muscle. This highlights the role of growth factors, including NGF, in peripheral muscle sensitization with clinical implications for ischaemic myalgia.",2019,"RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05).","['healthy humans assessed', 'Twenty-one subjects participated in two experimental phases, each including five sessions over 7\xa0days, with a gap of 4\xa0weeks in-between']","['control injections (isotonic-saline', 'Nerve Growth Factor (NGF']","['Higher NRS pain scores of ischaemic-contractions', 'contraction-evoked pain responses and pain sensitivity', 'ischaemic contraction-evoked pain', 'Likert scores of pain', 'Muscle pain intensity evoked with daily functional tasks (Likert scale score', 'Pressure pain thresholds (PPTs', 'Decreased PPTs', 'Pain', 'pain evoked following ischaemic contractions', 'Pain intensity evoked by ischaemic and non-ischaemic contractions numerical rating scale (NRS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}]",21.0,0.0926177,"RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05).","[{'ForeName': 'Line Bay', 'Initials': 'LB', 'LastName': 'Sørensen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Biomedicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1455']
779,31255452,Twelve-month angiographic and clinical outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold and a metallic stent in patients with coronary artery disease.,"BACKGROUND


Recent studies showed bioresorbable scaffold (BRS) increased risks of late target lesion failure (TLF) and thrombosis. XINSORB scaffold is a poly-L-lactic acid based BRS.
METHODS


The study included randomization and registry parts. Eligible patients with one or two de novo lesions were randomly 1:1 assigned to XINSORB scaffold and sirolimus-eluting stent (SES) in randomization part. These patients were clinically and angiographically assessed. In registry part, patients were treated with XINSORB scaffold only and were clinically assessed. The primary endpoint was in-segment late luminal loss (LLL) at 12-month in randomization part. The secondary endpoint was 12-month TLF in all XINSORB-treated patients.
RESULTS


Total 395 and 798 patients were enrolled in randomization and registry part, respectively. Device success was 98.0% (1069/1091) in all XINSORB-treated and 100% (221/221) in SES-treated lesions. The primary endpoint of in-segment LLL at 12-month was 0.19 ± 0.32 mm in XINSORB and 0.31 ± 0.41 mm in SES (P = 0.003), which met the noninferior margin of 0.195 mm (95% CI: -0.20, -0.04, P ≪ 0.0001). No difference was found in TLF between two devices. In all XINSORB-treated patients, 12-month TLF was 0.8% (8/998), which also met the noninferior margin of 9.0% (95% CI: 0.3%, 1.4%, P ≪ 0.0001). Only one device thrombosis was recorded in all XINSORB-treated patients while none in SES.
CONCLUSIONS


In the multicenter clinical trial, XINSORB BRS was noninferior to sirolimus-eluting stent for the primary endpoint of in-segment LLL at 12-month in patients with simple and moderate complex de novo coronary lesions. TLF at 12-month was low and comparable.",2019,Device success was 98.0% (1069/1091) in all XINSORB-treated and 100% (221/221) in SES-treated lesions.,"['Eligible patients with one or two de novo lesions', '395 and 798 patients were enrolled in randomization and registry part, respectively', 'patients with coronary artery disease']","['metallic stent', 'sirolimus-eluting stent', 'TLF', 'XINSORB scaffold and sirolimus-eluting stent (SES']","['segment late luminal loss (LLL', 'TLF', 'Device success', 'segment LLL', '12-month TLF', 'device thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]","[{'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",798.0,0.0618501,Device success was 98.0% (1069/1091) in all XINSORB-treated and 100% (221/221) in SES-treated lesions.,"[{'ForeName': 'Yizhe', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiasheng', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: ge.lei@zs-hospital.sh.cn.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: ge.junbo2@zs-hospital.sh.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.06.053']
780,31281046,"A comparison of angina symptoms reported by clinicians and patients, pre and post revascularisation: Insights from the Stent or Surgery Trial.","BACKGROUND


There are limited data comparing the consistency of angina reporting by patients and clinicians.
METHODS


We performed a retrospective analysis of data from the randomised Stent or Surgery (SoS) trial. The trial required reporting of angina using the Canadian Cardiovascular Society (CCS) classification by both patients and clinicians at baseline and twelve months. We compared paired observations to describe the magnitude and direction of differences in clinician and patient reporting. The difference in CCS grade was expressed as the clinician minus patient value. We also examined the proportion of trial subjects reported as being free from angina (CCS = 0) in clinician and patient reporting.
RESULTS


Paired CCS data was available for 912 and 887 cases at baseline and 12 months respectively. At baseline, clinicians reported freedom from angina in a single case (1/912 = 0.1%) compared to 70/912 (7.7%) patients (Delta 7.6% 95% CI 5.8 to 9.3, P ≤0.001). At 12 months, the position was reversed, with clinicians reporting 639/887 (72%) angina free compared to 449/887 (50.6%) for patients (Delta -21.4 95% CI -17.1 to -25.8 P ≤ 0.001). For the reported CCS grade at follow-up, the weighted linear kappa for overall agreement was 0.312. Discordant reporting involved the clinician suggesting less angina rather than more (36% v 8% of cases).
CONCLUSIONS


These findings have implications for our perception of previous research which has, in the main, focussed on clinician reporting. This emphasises the importance of patient reporting and a need to better understand reasons for discordance.",2019,"At baseline, clinicians reported freedom from angina in a single case (1/912 = 0.1%) compared to 70/912 (7.7%) patients (Delta 7.6% 95% CI 5.8 to 9.3, P ≤0.001).",[],[],['CCS grade'],[],[],"[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.0965867,"At baseline, clinicians reported freedom from angina in a single case (1/912 = 0.1%) compared to 70/912 (7.7%) patients (Delta 7.6% 95% CI 5.8 to 9.3, P ≤0.001).","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kemp', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, UK. Electronic address: ian.kemp@lhch.nhs.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Appleby', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Department of Biostatistics, University of Liverpool, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lisboa', 'Affiliation': 'Dept. of Applied Mathematics, Faculty of Engineering and Technology, Liverpool John Moores University, UK.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Stables', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, UK.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.06.052']
781,31982203,The Look After Yourself (LAY) intervention to improve self-management in stroke survivors: Results from a quasi-experimental study.,"OBJECTIVE


To test the efficacy of a self-management intervention for stroke survivors vs. usual care.
METHODS


Using a quasi-experimental study, participants were recruited from three public Italian hospitals. Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI) were administered at baseline, discharge and two months after discharge. Mixed models with a propensity score were used between experimental group (EG) and control group (CG). Logistic models were used to compare the use of health services.
RESULTS


Eighty-two stroke survivors were enrolled in the EG and 103 in the CG. Self-efficacy in self-management improved in the EG compared to the CG during hospitalization. Improvements from baseline to discharge were found in the EG in the mental component of SF-12 and in MBI. The EG were 8.9 times more likely to contact general practitioners after discharge and 2.9 times to do regular exercise than CG. Notably, EG with higher education benefitted more from the intervention.
CONCLUSION


The intervention was efficacious in improving self-efficacy, mental health and activities of daily living.
PRACTICE IMPLICATIONS


Structured educational interventions based on problem-solving and individual goal setting may improve self-management skills in stroke survivors.",2020,"Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI) were administered at baseline, discharge and two months after discharge.","['stroke survivors vs. usual care', 'participants were recruited from three public Italian hospitals', 'stroke survivors', 'Eighty-two stroke survivors']","['Structured educational interventions', 'Yourself (LAY) intervention', 'self-management intervention']","['self-efficacy, mental health and activities of daily living', 'Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C2607857'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0274552,"Questionnaires assessing self-efficacy (SSEQ), quality of life (SF-12), physical performance (SPPB), depression (GDS) and activities of daily living (MBI) were administered at baseline, discharge and two months after discharge.","[{'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Messina', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy. Electronic address: laura.dallolio@unibo.it.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Fugazzaro', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rucci', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Iommi', 'Affiliation': 'Advanced School for Health Policy-Specialisation School for Public Administration, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bardelli', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Department of Surgery, Medicine, Dentistry and Morphological Sciences-University of Modena and Reggio-Emilia, Modena, Italy; Scientific Directorate-Local Health Authority-IRCCS of Reggio-Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Denti', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Monia Allisen', 'Initials': 'MA', 'LastName': 'Accogli', 'Affiliation': 'Physical Medicine and Rehabilitation Unit-Local Health Authority-IRCCS of Reggio Emilia, Reggio-Emilia, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Cavalli', 'Affiliation': 'University Hospital Authority St. Orsola-Malpighi Polyclinic, Bologna, Italy.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Pagliacci', 'Affiliation': 'Department of Community Health Care Agency USL Tuscany, Northwest, Pisa, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Fantini', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Section of Hygiene and Biostatistics, Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Taricco', 'Affiliation': 'University Hospital Authority St. Orsola-Malpighi Polyclinic, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Patient education and counseling,['10.1016/j.pec.2020.01.004']
782,29889599,Pain management using a multimodal physiotherapy program including a biobehavioral approach for chronic nonspecific neck pain: a randomized controlled trial.,"Objective : To determine the effectiveness of a therapeutic patient education (TPE) intervention based on a biobehavioral approach combined with manual therapy (MT) to reduce pain in patients with chronic nonspecific neck pain (CNSNP). In addition, this study intended to assess the effectiveness of a multimodal physiotherapy program including TPE to reduce pain in patients with CNSNP.  Design : Single-blind randomized controlled trial.  Interventions : A total of 47 patients with CNSNP were randomized into three groups: (1) MT (control group); (2) MT plus TPE based on a biobehavioral approach (Exp1); and (3) MT plus TPE based on a biobehavioral approach, and therapeutic exercise (Exp2).  Main Outcome Measurements : The clinical outcomes were recorded at baseline and at 1 and 4 months after the initiation of treatment. The primary outcome was pain intensity (Visual Analog Scale), and the secondary outcomes were pain catastrophizing (Pain Catastrophizing Scale), illness severity and global improvement (Clinical Global Impression Scale), and mechanosensitivity of the median nerve (Upper Limb Neural Test) and the cervical region (Modified Passive Neck Flexion Test).  Results : Statistically significant differences in pain intensity were found when Exp2 was compared with Exp1 and the control group at 4 months ( p  = 0.015 and  p  = 0.001, respectively), but no difference was found between Exp1 and the control group at the same follow-up period ( p  = 0.86). Exp2 showed statistically significant differences in all of the secondary outcomes except for pain catastrophizing when compared with the control group at 4 months.  Conclusions : The Exp2 group was more effective than Exp1 and the control group in terms of reducing pain intensity at 4 months; at post-treatment, only Exp2 was more effective than the control group.",2020,"The Exp2 group was more effective than Exp1 and the control group in terms of reducing pain intensity at 4 months; at post-treatment, only Exp2 was more effective than the control group.","['patients with CNSNP', 'patients with chronic nonspecific neck pain (CNSNP', '47 patients with CNSNP', 'chronic nonspecific neck pain']","['multimodal physiotherapy program', 'biobehavioral approach combined with manual therapy (MT', 'MT (control group); (2) MT plus TPE based on a biobehavioral approach (Exp1); and (3) MT plus TPE based on a biobehavioral approach, and therapeutic exercise (Exp2', 'multimodal physiotherapy program including TPE', 'therapeutic patient education (TPE) intervention']","['pain catastrophizing', 'pain intensity (Visual Analog Scale), and the secondary outcomes were pain catastrophizing (Pain Catastrophizing Scale), illness severity and global improvement (Clinical Global Impression Scale), and mechanosensitivity of the median nerve (Upper Limb Neural Test) and the cervical region (Modified Passive Neck Flexion Test', 'pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4042874', 'cui_str': 'Biobehavioral Model'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0222045'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0560753', 'cui_str': 'Passive neck flexion test'}]",47.0,0.159892,"The Exp2 group was more effective than Exp1 and the control group in terms of reducing pain intensity at 4 months; at post-treatment, only Exp2 was more effective than the control group.","[{'ForeName': 'Ibai', 'Initials': 'I', 'LastName': 'López-de-Uralde-Villanueva', 'Affiliation': 'Department of Physiotherapy, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Beltran-Alacreu', 'Affiliation': 'Department of Physiotherapy, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Movement Sciences (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autonóma de Madrid, Madrid, Spain.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Department of Physiotherapy, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1480678']
783,31964579,"Effects of an educational intervention on heart failure knowledge, self-care behaviors, and health-related quality of life of patients with heart failure: Exploring the role of depression.","OBJECTIVES


To test effects of an educational intervention on patient-reported outcomes among rural heart failure (HF) patients and to examine whether effects differed between patients with and without depression.
METHODS


Patients (N = 614) were randomized to usual care (UC) or 1 of 2 intervention groups. Both intervention groups received face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS). Follow-up lasted 24 months. Statistical analyses included linear mixed models and subgroup analyses by depression status.
RESULTS


Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001). Improvement lasted 24 months only in the PLUS group. Compared to UC, both intervention groups exhibited better self-care at 3 months (LITE-UC, p < 0.001; PLUS-UC, p < 0.001) and 12 months (LITE-UC, p = 0.001; PLUS-UC, p = 0.002). There were no differences in health-related quality of life (HRQOL) among groups. In subgroup analyses, similar effects were found among non-depressed, but not among depressed patients.
CONCLUSION


The educational intervention improved HF knowledge and self-care, but not HRQOL. No intervention effects were observed in patients with depressive symptoms.
PRACTICE IMPLICATIONS


The simple educational intervention is promising to improve HF knowledge and self-care. Additional strategies are needed for depressed patients.",2020,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","['Patients (N\u202f=\u202f614', 'rural heart failure (HF) patients', 'patients with depressive symptoms', 'patients with and without depression', 'patients with heart failure']","['face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS', 'usual care (UC', 'educational intervention']","['HF knowledge', 'HF knowledge and self-care', 'health-related quality of life (HRQOL', 'heart failure knowledge, self-care behaviors, and health-related quality of life', 'self-care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",614.0,0.0257365,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","[{'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Hwang', 'Affiliation': 'College of Nursing & Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: bhwang@snu.ac.kr.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Pelter', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.007']
784,31927028,Gabapentin for pain management after osmotic dilator insertion and prior to dilation and evacuation: A randomized controlled trial.,"OBJECTIVE


To evaluate if gabapentin 600 mg reduces pain after osmotic dilator placement the day before a dilation and evacuation (D&E) procedure.
STUDY DESIGN


We conducted a double-blind, placebo-controlled, randomized (stratified by vaginal parity) trial among women undergoing osmotic dilator placement before D&E at 15-23 5/7 weeks gestation. Subjects received gabapentin 600 mg or placebo 30 min before dilator placement, with re-dosing 8 h later. We assessed pain after dilator placement using a numeric rating scale (NRS; scale 0-10) at 5 min, 2, 4, and 8 h, and at presentation for D&E. The primary outcome was median NRS pain score change from baseline to 8 h after dilator placement. Secondary outcomes included gabapentin-related side effects and analgesic use.
RESULTS


Of 121 randomized women, we excluded three subjects (allergic reaction [placebo], randomization error, no NRS data), leaving 60 gabapentin and 58 placebo subjects. Of 110 (93%) women who provided 8-hour data, median pain score changes from baseline did not differ between gabapentin and placebo groups overall (2 vs. 2.5, p = 0.52), in vaginally nulliparous women (2 vs. 4, p = 0.10) or in parous women (2 vs. 1.5, p = 0.37). We found no statistically significant differences in median pain score change from baseline to any timepoint overall or when stratified by parity. Beginning at 2 h after dilator placement, more gabapentin than placebo users experienced dizziness (29/53[55%] vs. 11/53[21%], p = 0.001) and tiredness (34/54[63%] vs. 17/54[31%], p = 0.002). The proportion of women using narcotics did not differ between gabapentin (35/60[58%]) or placebo (40/58[69%]) users (p = 0.26).
CONCLUSIONS


Gabapentin does not reduce pain with overnight osmotic dilator placement prior to D&E and causes drug-related side effects.
IMPLICATIONS STATEMENT


Women experience pain, mostly mild to moderate, with overnight cervical dilator placement at 15-23 5/7 weeks gestation. About 2/3 of women will use a limited quantity of narcotics if provided. Gabapentin does not decrease the pain with or following dilator placement and does not decrease narcotic use.",2020,We found no statistically significant differences in median pain score change from baseline to any timepoint overall or when stratified by parity.,"['three subjects (allergic reaction [placebo], randomization error, no NRS data), leaving 60 gabapentin and 58 placebo subjects', 'women undergoing osmotic dilator placement before D&E at 15 to 23 5/7 weeks gestation', 'Pain Management after Osmotic Dilator Insertion and prior to Dilation and Evacuation', '121 randomized women']","['placebo', 'gabapentin', 'Gabapentin', 'gabapentin 600 mg or placebo']","['median pain score change', 'dizziness', 'tiredness', 'median NRS pain score change', 'pain', 'gabapentin-related side effects and analgesic use', 'proportion of women using narcotics', 'median pain score changes']","[{'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C2978027', 'cui_str': 'gabapentin 600 MG [Gralise]'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}]",121.0,0.865522,We found no statistically significant differences in median pain score change from baseline to any timepoint overall or when stratified by parity.,"[{'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA. Electronic address: mdcreinin@ucdavis.edu.'}, {'ForeName': 'Natasha R', 'Initials': 'NR', 'LastName': 'Schimmoeller', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Matulich', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Melody Y', 'Initials': 'MY', 'LastName': 'Hou', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Melo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.'}]",Contraception,['10.1016/j.contraception.2019.12.001']
785,29863450,Predictors for adherence to a home-based pelvic floor muscle exercise program for treating female urinary incontinence in Brazil.,"Objective : To assess predictors for adherence to a home-based pelvic floor muscle exercise (PFME) program supplemented with three physical therapy sessions in women with urinary incontinence (UI).  Design : Secondary analysis of a randomized controlled trial of interventions to enhance self-efficacy with respect to PFME.  Setting : Patients were referred from public primary or secondary care providers in Florianópolis, Brazil.  Participants : Adult women with UI.  Intervention : Three supervised physiotherapy sessions for the treatment of UI combined with home-based PFME program. Treatment groups were combined for predictive modelling because there was no difference after intervention between groups regarding UI and adherence rates.  Main Outcome Measures : Adherence to PFME at 3-month follow-up (structured questionnaire). Baseline Predictors: self-efficacy and outcome expectation scales; severity of UI (ICIQ-SF), pelvic floor muscle strength, age, body mass index (BMI), and educational level.  Results : 86 women with UI of whom 72 completed the study. An intention-to-treat analysis was performed. Forty-three women reported carrying out PFME every day. Adherence was correlated to: baseline self-efficacy ( r  = 0.299); age ( r  = 0.242); and educational level ( r  = -0.273). Hierarchical regression analyses incorporating treatment group, age, education, disease-related factors (severity of UI; pelvic floor muscle strength; BMI), and outcome expectations and self-efficacy showed that only baseline self-efficacy predicted adherence ( R 2  = 0.217).  Conclusions : Adherence to home-based PFME is a complex phenomenon. Assessing self-efficacy may help physiotherapists to detect patients' confidence in performing home-based exercises and, when necessary, give patients additional incentives.",2020,"Treatment groups were combined for predictive modelling because there was no difference after intervention between groups regarding UI and adherence rates.
","['Adult women with UI', 'Forty-three women reported carrying out PFME every day', '86 women with UI of whom 72 completed the study', 'female urinary incontinence in Brazil', 'women with urinary incontinence (UI', 'Patients were referred from public primary or secondary care providers in Florianópolis, Brazil']","['UI combined with home-based PFME program', 'PFME', 'home-based pelvic floor muscle exercise (PFME) program supplemented with three physical therapy sessions', 'home-based pelvic floor muscle exercise program']","['baseline self-efficacy', 'Adherence', 'Baseline Predictors: self-efficacy and outcome expectation scales; severity of UI (ICIQ-SF), pelvic floor muscle strength, age, body mass index (BMI), and educational level', 'UI and adherence rates', 'educational level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0633055', 'cui_str': 'PFME'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0633055', 'cui_str': 'PFME'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0222045'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",86.0,0.0464654,"Treatment groups were combined for predictive modelling because there was no difference after intervention between groups regarding UI and adherence rates.
","[{'ForeName': 'Cinara', 'Initials': 'C', 'LastName': 'Sacomori', 'Affiliation': ""School of Kinesiology, Universidad Bernardo O'Higgins, Santiago de Chile, Chile.""}, {'ForeName': 'Bary', 'Initials': 'B', 'LastName': 'Berghmans', 'Affiliation': 'Pelvic care Centre Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'de Bie', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Mesters', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Fernando Luiz', 'Initials': 'FL', 'LastName': 'Cardoso', 'Affiliation': 'Department of Health Sciences, Centre of Health and Sports Sciences, Universidade do Estado de Santa Catarina, Florianópolis, SC, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1482583']
786,29889597,A feasibility study of brain-targeted treatment for people with painful knee osteoarthritis in tertiary care.,"Purpose : To assess the feasibility and clinical impact of brain-targeted treatment (BT; aiming to target sensorimotor processing) in knee osteoarthritis patients attending tertiary care.  Methods : Randomized replicated case series. The study involved three phases, each of 2 weeks duration: (1) no-treatment phase; (2) BT phase (left/right judgments and touch discrimination training); and (3) usual care (education, strengthening, and stretching training). Primary outcomes were: timely recruitment; number of participants completing the interventions; treatment compliance and barriers; follow-up rates; and treatment impact on pain and function. Fear-avoidance beliefs and clinical measures of cortical body representation (tactile acuity and left/right judgment performance) were secondary outcomes.  Result s: A total of 5% (19/355) of all assessed patients were eligible to participate and of these, 58% (11/19) agreed to participate. Ten patients completed the study, and 9 were successfully followed up, with treatment compliance varying between interventions. Compliance was poor for the touch discrimination component of BT. No significant effects were observed for pain relief or knee function after any treatment. A positive impact of treatment was found for fear-avoidance beliefs (usual care vs. washout,  p  = 0.007; BT vs. washout,  p  = 0.029) and left/right judgment accuracy (usual care vs. washout;  p  = 0.006).  Conclusions : Clear barriers were identified to implementing BT in tertiary care for knee osteoarthritis. Access to all available services (especially the use of interpreters), and treatment options that do not require additional assistance to perform (e.g., touch discrimination training) represent the main lessons learned.",2020,"A positive impact of treatment was found for fear-avoidance beliefs (usual care vs. washout, p = ","['people with painful knee osteoarthritis in tertiary care', 'knee osteoarthritis patients attending tertiary care', 'A total of 5% (19/355) of all assessed patients were eligible to participate and of these, 58% (11/19) agreed to participate']","['brain-targeted treatment (BT', 'brain-targeted treatment', 'usual care (education, strengthening, and stretching training']","['Fear-avoidance beliefs and clinical measures of cortical body representation (tactile acuity and left/right judgment performance', 'pain relief or knee function', 'fear-avoidance beliefs', 'timely recruitment; number of participants completing the interventions; treatment compliance and barriers; follow-up rates; and treatment impact on pain and function', 'left/right judgment accuracy']","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3489573', 'cui_str': 'Body Representation'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0374721,"A positive impact of treatment was found for fear-avoidance beliefs (usual care vs. washout, p = ","[{'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Harms', 'Affiliation': 'Department of Physiotherapy, Northern Hospital, Epping, Victoria, Australia.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Heredia-Rizo', 'Affiliation': 'Physiotherapy Department, Faculty of Nursing, Physiotherapy and Podiatry, Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'G Lorimer', 'Initials': 'GL', 'LastName': 'Moseley', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide, South Australia.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Hau', 'Affiliation': 'Northern Clinical School of Melbourne Medical School, Northern Hospital, Epping, Victoria, Australia.'}, {'ForeName': 'Tasha R', 'Initials': 'TR', 'LastName': 'Stanton', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide, South Australia.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1482391']
787,31881392,Cenicriviroc for the treatment of liver fibrosis in adults with nonalcoholic steatohepatitis: AURORA Phase 3 study design.,"INTRODUCTION


Nonalcoholic steatohepatitis (NASH) is a sub-classification of nonalcoholic fatty liver disease (NAFLD) characterized by increased risk of progressive liver fibrosis. Cenicriviroc (CVC) is a novel, orally administered, potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with NASH.
METHODS AND ANALYSIS


Efficacy and safety of CVC will be comprehensively evaluated in a global, Phase 3, multicenter, randomized, double-blind, placebo-controlled study (AURORA, NCT03028740) of subjects with NASH and Stage F2 or F3 fibrosis. Approximately 2000 adults (Part 1, 1200 subjects; Part 2, 800 additional subjects) aged 18-75 years with histological evidence of NASH with Stage F2 or F3 fibrosis (NASH Clinical Research Network classification system) will be randomized 2:1 to CVC 150 mg or placebo orally once daily. Primary efficacy endpoints will include the proportion of subjects with ≥1-stage improvement in liver fibrosis and no worsening of steatohepatitis at Month 12 relative to screening (Part 1), and time to first occurrence of any adjudicated event: death; histopathologic progression to cirrhosis; liver transplant; Model of End-Stage Liver Disease score ≥ 15; ascites; hospitalization due to liver decompensation (Part 2). Patient-reported outcomes will assess changes in health outcomes from baseline (Chronic Liver Disease Questionnaire - NAFLD; Work Productivity and Activity Impairment in NASH; 36-Item Short Form Health Survey version 2). Adverse events will be assessed throughout the study. As there are currently no approved treatments indicated for NASH, the AURORA CVC Phase 3 study addresses an unmet medical need.",2020,"Cenicriviroc (CVC) is a novel, orally administered, potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with NASH.
","['subjects with NASH and Stage F2 or F3 fibrosis', 'Approximately 2000 adults (Part 1, 1200 subjects; Part 2, 800 additional subjects) aged 18-75\u202fyears with histological evidence of NASH with Stage F2 or F3 fibrosis (NASH Clinical Research Network classification system', 'liver fibrosis in adults with NASH', 'adults with nonalcoholic steatohepatitis']","['CVC', 'CVC 150\u202fmg or placebo', 'Nonalcoholic steatohepatitis (NASH', 'placebo', 'Cenicriviroc (CVC']","['Adverse events', 'proportion of subjects with ≥1-stage improvement in liver fibrosis and no worsening of steatohepatitis at Month 12 relative to screening (Part 1), and time to first occurrence of any adjudicated event: death; histopathologic progression to cirrhosis; liver transplant; Model of End-Stage Liver Disease score\u202f≥\u202f15; ascites; hospitalization due to liver decompensation (Part 2', 'health outcomes from baseline (Chronic Liver Disease Questionnaire - NAFLD; Work Productivity and Activity Impairment']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C4279622'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",1200.0,0.117715,"Cenicriviroc (CVC) is a novel, orally administered, potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with NASH.
","[{'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Institute of Translational & Clinical Research, 4(th) floor, William Leech Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne NE2 4HH, UK. Electronic address: quentin.anstee@newcastle.ac.uk.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Saint Louis University, 3635 Vista Avenue, St. Louis, MO 63110, USA.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Chinese University of Hong Kong, Department of Medicine and Therapeutics, 9/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT, Hong Kong, China.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Duke University, 40 Duke Medicine Circle, Durham, NC 27710, USA.'}, {'ForeName': 'Zobair M', 'Initials': 'ZM', 'LastName': 'Younossi', 'Affiliation': 'Center for Liver Diseases and Department of Medicine, Inova Fairfax Medical Campus, 3300 Gallows Road, Falls Church, VA 22042, USA.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Allergan plc, 2525 Dupont Drive, Irvine, CA 92612, USA.'}, {'ForeName': 'Maria Lucia', 'Initials': 'ML', 'LastName': 'Pecoraro', 'Affiliation': 'Allergan plc, 701 Gateway Boulevard, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Star', 'Initials': 'S', 'LastName': 'Seyedkazemi', 'Affiliation': 'Allergan plc, 701 Gateway Boulevard, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Fischer', 'Affiliation': 'Allergan plc, 701 Gateway Boulevard, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bedossa', 'Affiliation': 'Hôpital Beaujon, 100 Boulevard du Général Leclerc, 92110 Clichy, France.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Center for Liver Diseases and Department of Medicine, Inova Fairfax Medical Campus, 3300 Gallows Road, Falls Church, VA 22042, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, University of Texas Health Science Center, 607 Camden Street, Suite 108, San Antonio, TX 78215, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tacke', 'Affiliation': 'Charité University Medical Center Berlin, Augustenburger Platz 1, D-13353 Berlin, Germany.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, 1201 East Marshall Street, Richmond, VA 23298, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105922']
788,31588504,The Risks of Cardiovascular Disease and Mortality Following Weight Change in Adults with Diabetes: Results from ADVANCE.,"CONTEXT


Weight loss is strongly recommended for overweight and obese adults with type 2 diabetes. Unintentional weight loss is associated with increased risk of all-cause mortality, but few studies have examined its association with cardiovascular outcomes in patients with diabetes.
OBJECTIVE


To evaluate 2-year weight change and subsequent risk of cardiovascular events and mortality in established type 2 diabetes.
DESIGN AND SETTING


The Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation was an international, multisite 2×2 factorial trial of intensive glucose control and blood pressure control. We examined 5 categories of 2-year weight change: >10% loss, 4% to 10% loss, stable (±<4%), 4% to 10% gain, and >10% gain. We used Cox regression with follow-up time starting at 2 years, adjusting for intervention arm, demographics, cardiovascular risk factors, and diabetes medication use from the 2-year visit.
RESULTS


Among 10 081 participants with valid weight measurements, average age was 66 years. By the 2-year examination, 4.3% had >10% weight loss, 18.4% had 4% to 10% weight loss, and 5.3% had >10% weight gain. Over the following 3 years of the trial, >10% weight loss was strongly associated with major macrovascular events (hazard ratio [HR], 1.75; 95% confidence interval [CI], 1.26-2.44), cardiovascular mortality (HR, 2.76; 95% CI, 1.87-4.09), all-cause mortality (HR, 2.79; 95% CI, 2.10-3.71), but not major microvascular events (HR, 0.91; 95% CI, 0.61-1.36), compared with stable weight. There was no evidence of effect modification by baseline body mass index, age, or type of diabetes medication.
CONCLUSIONS


In the absence of substantial lifestyle changes, weight loss may be a warning sign of poor health meriting further workup in patients with type 2 diabetes.",2020,"There was no evidence of effect modification by baseline BMI, age, or type of diabetes medication.
","['10,081 participants with valid weight measurements, average age was 66 years', 'patients with diabetes', 'Adults with Diabetes', 'patients with type 2 diabetes', 'overweight and obese adults with type 2 diabetes']",['intensive glucose control and blood pressure control'],"['Unintentional weight loss', 'cardiovascular mortality', 'cause mortality', 'major macrovascular events', 'weight loss', 'major microvascular events', '2-year weight change and subsequent risk of cardiovascular events and mortality']","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C2363736', 'cui_str': 'Involuntary weight loss'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0634737,"There was no evidence of effect modification by baseline BMI, age, or type of diabetes medication.
","[{'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The G eorge Institute for Global Health, Sydney 2042, Australia.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Warren', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'A Richey', 'Initials': 'AR', 'LastName': 'Sharrett', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Sciences, University College London, London, WC1E 6BT, UK.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Fondation Opthalmologique Adolphe de Rothschild, Université Denis Diderot, 75019 Paris, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hamet', 'Affiliation': ""Center de Rechercher, Center Hospitalier de l'Université de Montréal (CRCHUM), Montréal, Québec H2X 0A9, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'Department of Physiology, Royal Melbourne Hospital, University of Melbourne, Victoria 3010, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Mcevoy', 'Affiliation': 'School of Medicine, National University of Ireland, Galway Campus, and National Institute for Preventive Cardiology, Galway, H91 TK33, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The G eorge Institute for Global Health, Sydney 2042, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Selvin', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz045']
789,31928846,Clinical and MRI Predictors of Conversion From Mild Behavioural Impairment to Dementia.,"OBJECTIVE


As an analogy with mild cognitive impairment (MCI), the mild behavioral impairment (MBI) construct has been proposed as a diagnostic label for those presenting late-onset behavioral symptoms. To date, however, the clinical, cognitive, and structural imaging features associated with an increased risk of conversion from MBI to dementia are poorly understood.
METHODS


We retrospectively analyzed the cognitive performance and structural brain MRI of 113 subjects, with a clinical follow-up of at least 4 years available. Subjects were randomly assigned to a Group A (56 subjects; age: 65.4 ± 7.9 years, 15 females, MMSE score: 28.4 ± 2.3)) or to a Group B (57 subjects, age: 66.6 ± 6.4, 17 females, MMSE score: 28.0 ± 1.4). In the Group A, cognitive and structural variables were compared between converters (at 4 years) and nonconverters and then verified in the Group B group.
RESULTS


In the Group A, 14 patients converted to behavioral-variant of frontotemporal dementia (bv-FTD) and 4 to Alzheimer's Disease (AD). Converters presented at baseline lower executive function scores and total Theory of Mind (ToM scores), as well as more severe focal frontal atrophy. In the Group B, 13 subjects converted to bv-FTD and none to AD. The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%).
CONCLUSION


The combined presence of executive deficit, impaired ToM, and presence of isolated frontal atrophy was associated with risk of progression from MBI to a clinically evident neurodegenerative condition, mainly bv-FTD, over a 4-year period.",2020,"The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%).
","['113 subjects, with a clinical follow-up of at least 4 years available', 'Subjects were randomly assigned to a Group A (56 subjects; age: 65.4 ± 7.9 years, 15 females, MMSE score: 28.4 ± 2.3)) or to a Group B (57 subjects, age: 66.6 ± 6.4, 17 females, MMSE score: 28.0 ± 1.4', ""14 patients converted to behavioral-variant of frontotemporal dementia (bv-FTD) and 4 to Alzheimer's Disease (AD""]",[],"['severe focal frontal atrophy', 'executive function scores and total Theory of Mind (ToM scores']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia (disorder)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",113.0,0.0375881,"The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Orso', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mattei', 'Affiliation': 'Bozen Civic Hospital (Chiara Mattei), Bozen, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arnaldi', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Massa', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Serafini', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Plantone', 'Affiliation': 'Neurology Unit, Di Venere Hospital (Domenico Plantone), Bari, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Doglione', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Grafman', 'Affiliation': 'Cognitive Neuroscience Laboratory, Shirley Ryan Ability Lab (Jordan Grafman), Chicago, IL.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pardini', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy. Electronic address: matteo.pardini@unige.it.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.12.007']
790,31926918,"Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study.","BACKGROUND


Chemoprevention of colorectal adenoma and colorectal cancer remains an important public health goal. The present study aimed to investigate the clinical potential and safety of berberine for prevention of colorectal adenoma recurrence.
METHODS


This double-blind, randomised, placebo-controlled trial was done in seven hospital centres across six provinces in China. Individuals aged 18-75 years who had at least one but no more than six histologically confirmed colorectal adenomas that had undergone complete polypectomy within the 6 months before recruitment were recruited and randomly assigned (1:1) to receive berberine (0·3 g twice daily) or placebo tablets via block randomisation (block size of six). Participants were to undergo a first follow-up colonoscopy 1 year after enrolment, and if no colorectal adenomas were detected, a second follow-up colonoscopy at 2 years was planned. The study continued until the last enrolled participant reached the 2-year follow-up point. All participants, investigators, endoscopists, and pathologists were blinded to treatment assignment. The primary efficacy endpoint was the recurrence of adenomas at any follow-up colonoscopy. Analysis was based on modified intention-to-treat, with the full analysis set including all randomised participants who received at least one dose of study medication and who had available efficacy data. The study is registered with ClinicalTrials.gov, number NCT02226185; the trial has ended and this report represents the final analysis.
FINDINGS


Between Nov 14, 2014, and Dec 30, 2016, 553 participants were randomly assigned to the berberine group and 555 to the placebo group. The full analysis set consisted of 429 participants in the berberine group and 462 in the placebo group. 155 (36%) participants in the berberine group and 216 (47%) in the placebo group were found to have recurrent adenoma during follow-up (unadjusted relative risk ratio for recurrence 0·77, 95% CI 0·66-0·91; p=0·001). No colorectal cancers were detected during follow-up. The most common adverse event was constipation (six [1%] of 446 patients in the berberine group vs one [<0·5%] of 478 in the placebo group). No serious adverse events were reported.
INTERPRETATION


Berberine 0·3 g twice daily was safe and effective in reducing the risk of recurrence of colorectal adenoma and could be an option for chemoprevention after polypectomy.
FUNDING


National Natural Science Foundation of China.",2020,The most common adverse event was constipation (six [1%] of 446 patients in the berberine group vs one [<0·5%] of 478 in the placebo group).,"['Individuals aged 18-75 years who had at least one but no more than six histologically confirmed colorectal adenomas that had undergone complete polypectomy within the 6 months before recruitment', 'seven hospital centres across six provinces in China', '429 participants in the berberine group and 462 in the', 'Between Nov 14, 2014, and Dec 30, 2016, 553 participants']","['placebo', 'berberine', 'berberine (0·3 g twice daily) or placebo tablets', 'Berberine versus placebo']","['serious adverse events', 'recurrence of adenomas at any follow-up colonoscopy', 'recurrence of colorectal adenoma', 'recurrent adenoma', 'colorectal cancers', 'risk of recurrence of colorectal adenoma']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",553.0,0.722249,The most common adverse event was constipation (six [1%] of 446 patients in the berberine group vs one [<0·5%] of 478 in the placebo group).,"[{'ForeName': 'Ying-Xuan', 'Initials': 'YX', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qin-Yan', 'Initials': 'QY', 'LastName': 'Gao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tian-Hui', 'Initials': 'TH', 'LastName': 'Zou', 'Affiliation': 'Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Bang-Mao', 'Initials': 'BM', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Si-De', 'Initials': 'SD', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jian-Qiu', 'Initials': 'JQ', 'LastName': 'Sheng', 'Affiliation': 'Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jian-Lin', 'Initials': 'JL', 'LastName': 'Ren', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Zou', 'Affiliation': 'Division of Gastroenterology and Hepatology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Zhan-Ju', 'Initials': 'ZJ', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University, Shanghai, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, Clinical Research Institute, Shanghai Jiao-Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xiao', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University, Shanghai, China.""}, {'ForeName': 'Xiao-Tan', 'Initials': 'XT', 'LastName': 'Dou', 'Affiliation': 'Division of Gastroenterology and Hepatology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Hai-Long', 'Initials': 'HL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xiao-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Kang', 'Affiliation': 'Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hong-Zhi', 'Initials': 'HZ', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Hui-Min', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiao-Chuang', 'Initials': 'XC', 'LastName': 'Cao', 'Affiliation': 'Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing-Yuan', 'Initials': 'JY', 'LastName': 'Fang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China. Electronic address: jingyuanfang@sjtu.edu.cn.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30409-1']
791,31927027,Postplacental placement of intrauterine devices: A randomized clinical trial.,"OBJECTIVE


To compare the expulsion rate of the TCu380A intrauterine device (IUD) or levonorgestrel (LNG) 52 mg intrauterine system (IUS) up to 90 days after postplacental placement (10 min after delivery of the placenta).
STUDY DESIGN


Randomized trial (1:1) of women aged 18-43 years and ≥37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil. Follow-up was scheduled at 42 and 90 days after device placement. We confirmed the IUD or IUS location using ultrasonography. Multivariate logistic regression was used to assess variables associated with expulsion.
RESULTS


We enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups. By the 90-day follow-up visit, 22/60 women (36.7%) in the TCu380A IUD group had expelled the device, as had 12/60 women in the IUS group (20%). Thirty-three of the 34 expulsions had occurred by the 42-day visit. Multivariate analysis demonstrated that the expulsion odds ratio ([OR]; 95% confidence interval [CI]) was higher after vaginal delivery than after Cesarean delivery (OR 5.60; 95% CI 2.08-15.10; P < 0.00) and higher among women with one (OR 4.38; 95% CI 1.33-14.43; P 0.00) or three or more deliveries (including the present one) (OR 6.08; 95% CI 1.78-20.77; P 0.00) than those with two deliveries.
CONCLUSIONS


Postplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery. Most of the expulsions occurred within 42 days.
IMPLICATIONS


Policy makers should increase the availability of both the TCu380A and the LNG intrauterine devices for the immediate postpartum period, even though the expulsion rate is higher than that after interval placement.",2020,"CONCLUSIONS


Postplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery.","['We enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups', 'women aged 18-43 years and ≥37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil']","['Postplacental placement of intrauterine devices', 'Postplacental TCu380A IUD placement', 'TCu380A intrauterine device', 'levonorgestrel (LNG) 52mg intrauterine system (IUS', 'TCu380A IUD']","['expulsion odds ratio', 'expulsion rate']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0937459', 'cui_str': 'levonorgestrel 52 MG 5 Year Intrauterine System'}]","[{'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",140.0,0.358485,"CONCLUSIONS


Postplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery.","[{'ForeName': 'Montas', 'Initials': 'M', 'LastName': 'Laporte', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Marangoni', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Surita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Cassia T', 'Initials': 'CT', 'LastName': 'Juliato', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Miadaira', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bahamondes', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil. Electronic address: bahamond@caism.unicamp.br.'}]",Contraception,['10.1016/j.contraception.2019.12.006']
792,29487402,Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects.,"Ketamine's mechanism of action was assessed using gamma power from magnetoencephalography (MEG) as a proxy measure for homeostatic balance in 35 unmedicated subjects with major depressive disorder (MDD) and 25 healthy controls enrolled in a double-blind, placebo-controlled, randomized cross-over trial of 0.5 mg/kg ketamine. MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration. Both groups showed increased resting gamma power following ketamine. In MDD subjects, gamma power was not associated with the magnitude of the antidepressant effect. However, baseline gamma power was found to moderate the relationship between post-ketamine gamma power and antidepressant response; specifically, higher post-ketamine gamma power was associated with better response in MDD subjects with lower baseline gamma, with an inverted relationship in MDD subjects with higher baseline gamma. This relationship was observed in multiple regions involved in networks hypothesized to be involved in the pathophysiology of MDD. This finding suggests biological subtypes based on the direction of homeostatic dysregulation and has important implications for inferring ketamine's mechanism of action from studies of healthy controls alone.",2019,"MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration.","['depressed and healthy subjects', '35 unmedicated subjects with major depressive disorder (MDD) and 25 healthy controls enrolled']","['Ketamine', 'ketamine', 'gamma power from magnetoencephalography (MEG', 'placebo']","['depressive symptoms', 'resting gamma power']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}]",35.0,0.0308105,"MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration.","[{'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nugenta@mail.nih.gov.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Ballard', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, Baltimore, MD, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Brutsche', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0028-2']
793,31959649,Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920.,,2020,,"['Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Placebo', 'Liraglutide']",['Acute Gallbladder or Biliary Disease'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0538329,,"[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Skelin', 'Affiliation': 'Department of Pharmacy, General Hospital Šibenik, Šibenik, Croatia marko.skelin@bolnica-sibenik.hr.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Rahelić', 'Affiliation': 'University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Skelin', 'Affiliation': 'Faculty of Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Lucijanic', 'Affiliation': 'Department of Hematology, Dubrava University Hospital, Zagreb, Croatia.'}]",Diabetes care,['10.2337/dc19-2039']
794,31959650,Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920.,,2020,,"['Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Placebo', 'Liraglutide']",['Acute Gallbladder or Biliary Disease'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.051179,,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Division, St. Josef-Hospital (Ruhr University), Bochum, Germany michael.nauck@rub.de.'}, {'ForeName': 'Eskil', 'Initials': 'E', 'LastName': 'Kreiner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dci19-0067']
795,31042621,Chronic repetitive transcranial magnetic stimulation (rTMS) on sleeping quality and mood status in drug dependent male inpatients during abstinence.,"BACKGROUND


Drug abstinence is accompanied by aversive experiences and lasting changes in mood status and worsening sleep quality. This study investigated the potential effects of chronic repetitive transcranial magnetic stimulation (rTMS) in substance dependent inpatients during abstinence.
METHODS


This was a double-blinded study with 105 males inpatients dependent on heroin or methamphetamine (average abstinence time was six months). The inpatients were randomly divided into 10 Hz intervention (n = 40), sham stimulation (n = 40) and control (waiting list, no treatment) (n = 25) groups. Five sessions of rTMS stimulation were administrated for six consecutive weeks, reaching a total of 180,000 pulses. There was no intervention for control group. Patients were assessed using the Pittsburgh Sleep Quality Index (PSQI), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) were assessed prior to and after six weeks of intervention.
RESULTS


The results showed that six weeks of rTMS treatment significantly improved the sleep quality (p < 0.001), alleviated depression (p < 0.001) and anxiety state (p < 0.001) of substance dependent inpatients in early abstinence. Furthermore, the active TMS group showed significant differences between sham and control groups.
CONCLUSION


These findings suggested that chronic rTMS treatment have positive effects for substance dependent inpatients during abstinence. Future studies are required to understand the underlying mechanism for improving different clinical symptoms.",2019,"The results showed that six weeks of rTMS treatment significantly improved the sleep quality (p < 0.001), alleviated depression (p < 0.001) and anxiety state (p < 0.001) of substance dependent inpatients in early abstinence.","['drug dependent male inpatients during abstinence', 'substance dependent inpatients during abstinence', 'n\xa0=\xa025', '105 males inpatients dependent on heroin or methamphetamine (average abstinence time was six months']","['Chronic repetitive transcranial magnetic stimulation (rTMS', 'chronic repetitive transcranial magnetic stimulation (rTMS', 'sham stimulation (n\xa0=\xa040) and control (waiting list, no treatment', 'Hz intervention', 'rTMS']","['Pittsburgh Sleep Quality Index (PSQI), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS', 'alleviated depression', 'anxiety state', 'sleep quality', 'sleeping quality and mood status']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",105.0,0.073819,"The results showed that six weeks of rTMS treatment significantly improved the sleep quality (p < 0.001), alleviated depression (p < 0.001) and anxiety state (p < 0.001) of substance dependent inpatients in early abstinence.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Medicine, Zhejiang Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Zhejiang Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhejiang Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Miaosen', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'Fuchun Addiction Rehabilitation Center, 1 Heshangling Road, Fuyang, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yongjin', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Fuchun Addiction Rehabilitation Center, 1 Heshangling Road, Fuyang, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Gudang Community Health Service Center, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Fuchun Addiction Rehabilitation Center, 1 Heshangling Road, Fuyang, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Zhejiang Hospital, Hangzhou, Zhejiang, China. Electronic address: Drzhangrui@163.com.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",Sleep medicine,['10.1016/j.sleep.2019.01.052']
796,31950977,Effect of Stress Ulcer Prophylaxis With Proton Pump Inhibitors vs Histamine-2 Receptor Blockers on In-Hospital Mortality Among ICU Patients Receiving Invasive Mechanical Ventilation: The PEPTIC Randomized Clinical Trial.,"Importance


Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs) are often prescribed for patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU). The comparative effect of these drugs on mortality is unknown.
Objective


To compare in-hospital mortality rates using PPIs vs H2RBs for stress ulcer prophylaxis.
Design, Setting, and Participants


Cluster crossover randomized clinical trial conducted at 50 ICUs in 5 countries between August 2016 and January 2019. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission were followed up for 90 days at the hospital.
Interventions


Two stress ulcer prophylaxis strategies were compared (preferential use with PPIs vs preferential use with H2RBs). Each ICU used each strategy sequentially for 6 months in random order; 25 ICUs were randomized to the sequence with use of PPIs and then use of H2RBs and 25 ICUs were randomized to the sequence with use of H2RBs and then use of PPIs (13 436 patients randomized by site to PPIs and 13 392 randomized by site to H2RBs).
Main Outcomes and Measures


The primary outcome was all-cause mortality within 90 days during index hospitalization. Secondary outcomes were clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay.
Results


Among 26 982 patients who were randomized, 154 opted out, and 26 828 were analyzed (mean [SD] age, 58 [17.0] years; 9691 [36.1%] were women). There were 26 771 patients (99.2%) included in the mortality analysis; 2459 of 13 415 patients (18.3%) in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients (17.5%) in the H2RB group died at the hospital by day 90 (risk ratio, 1.05 [95% CI, 1.00 to 1.10]; absolute risk difference, 0.93 percentage points [95% CI, -0.01 to 1.88] percentage points; P = .054). An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs. Clinically important upper gastrointestinal bleeding occurred in 1.3% of the PPI group and 1.8% of the H2RB group (risk ratio, 0.73 [95% CI, 0.57 to 0.92]; absolute risk difference, -0.51 percentage points [95% CI, -0.90 to -0.12 percentage points]; P = .009). Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group. One adverse event (an allergic reaction) was reported in 1 patient in the PPI group.
Conclusions and Relevance


Among ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication.
Trial Registration


anzctr.org.au Identifier: ACTRN12616000481471.",2020,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"['50 ICUs in 5 countries between August 2016 and January 2019', 'ICU patients requiring mechanical ventilation', 'Patients Receiving Invasive Mechanical Ventilation', 'Patients requiring invasive mechanical ventilation within 24 hours of ICU admission', 'patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU', '17.0] years; 9691 [36.1%] were women', '26\u202f982 patients who were randomized, 154 opted out, and 26\u202f828 were analyzed (mean [SD] age, 58']","['ICU', 'Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs', 'PPIs vs H2RBs', 'Proton Pump Inhibitors vs Histamine-2 Receptor Blockers', 'anzctr.org.au Identifier']","['hospital mortality rates', 'cause mortality', 'Hospital Mortality', 'Clinically important upper gastrointestinal bleeding', 'clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay', 'Rates of Clostridioides difficile infection and ICU and hospital lengths of stay']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2741638', 'cui_str': 'Stress ulcer (disorder)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.126156,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'Biostatistics Unit, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Intensive Care Unit, Freeman Hospital, Newcastle upon Tyne, England.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Brickell', 'Affiliation': ""University College Dublin-Clinical Research Centre, St Vincent's Hospital, Dublin, Ireland.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gattas', 'Affiliation': 'Intensive Care Unit, Royal Prince Alfred Hospital, Camperdown, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Intensive Care Unit, Canberra Hospital, Canberra, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Leanlove', 'Initials': 'L', 'LastName': 'Navarra', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Opgenorth', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pilcher', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Saxena', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Steve A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}]",JAMA,['10.1001/jama.2019.22190']
797,31951273,Assessment of Anatomic Restoration of Distal Radius Fractures Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


The value of precise anatomic restoration for distal radius fractures (DRFs) in older adults has been debated for many decades, with conflicting results in the literature. In light of the growing population of adults aged 60 years and older, both fracture incidence and associated treatment costs are expected to increase.
Objective


To determine the association between radiographic measures of reduction and patient outcomes after DRF in older patients.
Design, Setting, and Participants


Data were collected from the Wrist and Radius Injury Surgical Trial (WRIST), a multicenter randomized clinical trial of DRF treatments for adults aged 60 years and older (enrollment from April 10, 2012, to December 31, 2016, with a 2-year follow-up). Data analysis was performed from January 3, 2019, to August 19, 2019. WRIST participants who completed 12-month assessments were included in the study. According to the biomechanical principle of alignment, 2-phase multivariable regression models were adopted to assess the association between radiographic measures of reduction and functional and patient-reported outcomes 12 months following treatment.
Interventions


Participants were randomized to receive volar locking plate, percutaneous pinning, or external fixation. Those who opted for nonoperative treatment received casts.
Main Outcomes and Measures


Hand grip strength, wrist arc of motion, radial deviation, ulnar deviation, the Michigan Hand Outcomes Questionnaire (MHQ) total score, MHQ function score, and MHQ activities of daily living score were measured at 12 months following treatment.
Results


Data from 166 WRIST participants (144 [86.7%] women; mean [SD] age, 70.9 [8.9] years) found that only 2 of the 84 correlation coefficients calculated were statistically significant. For patients aged 70 years or older, every degree increase in radial inclination away from normal (22°) grip strength in the injured hand was 1.1 kg weaker than the uninjured hand (95% CI, 0.38-1.76; P = .004) and each millimeter increase toward normal (0 mm) in ulnar variance was associated with a 10.4-point improvement in MHQ ADL score (95% CI, -16.84 to -3.86; P = .003). However, neither of these radiographic parameters appeared to be associated with MHQ total or function scores.
Conclusions and Relevance


The study results suggest that precise restoration of wrist anatomy is not associated with better patient outcomes for older adults with DRF 12 months following treatment. Surgeons can consider this evidence to improve quality of care by prioritizing patient preferences and efficient use of resources over achieving exact realignment.
Trial Registration


ClinicalTrials.gov identifier: NCT01589692.",2020,The study results suggest that precise restoration of wrist anatomy is not associated with better patient outcomes for older adults with DRF 12 months following treatment.,"['Older Adults', 'adults aged 60 years and older (enrollment from April 10, 2012, to December 31, 2016, with a 2-year follow-up', 'older patients', 'older adults', 'Distal Radius Fractures', 'WRIST participants who completed 12-month assessments were included in the study']","['DRF', 'volar locking plate, percutaneous pinning, or external fixation']","['radial inclination away from normal (22°) grip strength', 'MHQ ADL score', 'MHQ total or function scores', 'Measures\n\n\nHand grip strength, wrist arc of motion, radial deviation, ulnar deviation, the Michigan Hand Outcomes Questionnaire (MHQ) total score, MHQ function score, and MHQ activities of daily living score']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0449751', 'cui_str': 'Radial deviation (qualifier value)'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation (qualifier value)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.158434,The study results suggest that precise restoration of wrist anatomy is not associated with better patient outcomes for older adults with DRF 12 months following treatment.,"[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Chung', 'Affiliation': 'Section of Plastic Surgery, Department of Surgery, Michigan Medicine, Ann Arbor.'}, {'ForeName': 'Hoyune E', 'Initials': 'HE', 'LastName': 'Cho', 'Affiliation': 'Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Yeonil', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Early Development Statistics, Merck & Co Inc, Rahway, New Jersey.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Shauver', 'Affiliation': 'Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2019.19433']
798,31899371,Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.,"INTRODUCTION


Physical activity monitors, motivational text messages, personal calls, and group meetings, have proven to be efficacious physical activity interventions. However, individual participant response to these interventions varies drastically. A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders. We describe a SMART to determine the most effective adaptive intervention to increase physical activity (steps, moderate-to-vigorous physical activity) and improve cardiovascular health among employed women who are not regularly physically active. The SMART uses combinations of four treatments: 1) enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings.
METHODS


Participants (N = 312) include women ages 18-70 employed at a large academic medical center. Women will be randomized to an initial intervention, either an enhanced physical activity monitor or enhanced physical activity monitor + text messaging. Non-responders to the initial intervention at 2 months will be randomized to either personal calls or groups meetings for the next 6 months. At 8 months, all participants will return to only an enhanced physical activity monitor until their final 12-month assessment.
DISCUSSION


Results of this study will add to the literature on improving physical activity in employed women. This study will identify effective interventions for women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.",2020,A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders.,"['women who respond to less intensive treatments', 'employed women who are not regularly physically active', 'employed women', 'Participants (N\u202f=\u202f312) include women ages 18-70 employed at a large academic medical center']","['enhanced physical activity monitor or enhanced physical activity monitor\u202f+\u202ftext messaging. Non-responders to the initial intervention', 'enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings']","['cardiovascular health', 'physical activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",70.0,0.0342475,A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders.,"[{'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Buchholz', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America. Electronic address: susan_buchholz@rush.edu.'}, {'ForeName': 'JoEllen', 'Initials': 'J', 'LastName': 'Wilbur', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Halloway', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schoeny', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Rush University, College of Health Sciences, Chicago, IL, United States of America.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Vispute', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Kitsiou', 'Affiliation': 'University of Illinois at Chicago, College of Applied Health Sciences, Chicago, IL, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105921']
799,31920458,Peer-support to increase uptake of screening for diabetic retinopathy: process evaluation of the DURE cluster randomized trial.,"Background


There is limited evidence on how implementation of peer support interventions influences effectiveness, particularly for individuals with diabetes. We conducted a cluster randomized controlled trial to compare the effectiveness of a peer-led health education package versus usual care to increase uptake of screening for diabetic retinopathy (DR).
Methods


Our process evaluation used a mixed-method design to investigate the recruitment and retention, reach, dose, fidelity, acceptability, and context of implementation, and was guided by the Consolidated Framework for Implementation Research (CFIR). We reviewed trial documents, conducted semi-structured interviews with key informants ( n  = 10) and conducted four focus group discussions with participants in both arms of the trial. Three analysts undertook CFIR theory-driven content analysis of the qualitative data. Quantitative data was analyzed to provide descriptive statistics relevant to the objectives of the process evaluation.
Results


The trial had positive implementation outcomes, 100% retention of clusters and 96% retention for participants, 83% adherence to delivery of content of group talks (fidelity), and 78% attendance (reach) to at least 50% (3/6) of the group talks (dose). The data revealed that intervention characteristics, outer setting, inner setting, individual characteristics, and process (all the constructs of CFIR) influenced the implementation. There were more facilitators than barriers to the implementation. Facilitators included the relative advantage of the intervention compared with current practice (intervention characteristics); awareness of the growing prioritization of diabetes in the national health policy framework (outer setting); tension for change due to the realization of the vulnerability to vision loss from DR (inner setting); a strong collective sense of accountability of peer supporters to implement the intervention (individual characteristics); and regular feedback on the progress with implementation (process). Potential barriers included the need to queue at the eye clinic (intervention characteristic), travel inconveniences (inner setting), and socio-political disruption (outer setting).
Conclusions


The intervention was implemented with high retention, reach, fidelity, and dose. The CFIR provided a valuable framework for evaluating contextual factors that influenced implementation and helped to understand what adaptations may be needed during scale up.
Trial registration


Pan African Clinical Trials Registry: PACTR201707002430195 registered 15 July 2017.",2020,"The CFIR provided a valuable framework for evaluating contextual factors that influenced implementation and helped to understand what adaptations may be needed during scale up.
","['diabetic retinopathy (DR', 'individuals with diabetes', 'diabetic retinopathy']",['peer-led health education package versus usual care'],['adherence to delivery of content of group talks (fidelity'],"[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018701'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]",,0.110516,"The CFIR provided a valuable framework for evaluating contextual factors that influenced implementation and helped to understand what adaptations may be needed during scale up.
","[{'ForeName': 'Nyawira', 'Initials': 'N', 'LastName': 'Mwangi', 'Affiliation': '1London School of Hygiene and Tropical Medicine, London, England.'}, {'ForeName': 'Covadonga', 'Initials': 'C', 'LastName': 'Bascaran', 'Affiliation': '1London School of Hygiene and Tropical Medicine, London, England.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ramke', 'Affiliation': '1London School of Hygiene and Tropical Medicine, London, England.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Kipturgo', 'Affiliation': '2Kenya Medical Training College, Nairobi, Kenya.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': '1London School of Hygiene and Tropical Medicine, London, England.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': ""Ng'ang'a"", 'Affiliation': 'Kerugoya County Referral Hospital, Kerugoya, Kenya.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gichuhi', 'Affiliation': '5University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Mutie', 'Affiliation': '2Kenya Medical Training College, Nairobi, Kenya.'}, {'ForeName': 'Consuela', 'Initials': 'C', 'LastName': 'Moorman', 'Affiliation': '6Oxford University NHS Trust, Oxford, UK.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Muthami', 'Affiliation': '7Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Foster', 'Affiliation': '1London School of Hygiene and Tropical Medicine, London, England.'}]",Tropical medicine and health,['10.1186/s41182-019-0188-z']
800,31566744,Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study.,"OBJECTIVE


To assess the efficacy and safety of cryoablation of the posterior nasal nerve (PNN) for treatment of chronic rhinitis.
METHODS


This was a prospective single-arm trial of 98 adult patients at six U.S. centers with chronic allergic and nonallergic rhinitis. PNN cryoablation was performed in-office under local anesthesia using a handheld device. Patients discontinued use of intranasal ipratropium 3 days prior to treatment and throughout the study period. Reflective Total Nasal Symptom Score (rTNSS) was measured at pretreatment baseline and posttreatment at 1 month, 3 months, 6 months, and 9 months. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed at pretreatment and 3 months posttreatment. Adverse effects and postprocedure medication usage were recorded.
RESULTS


Ninety-eight procedures (100%) were successfully completed. rTNSS significantly improved over pretreatment baseline (6.1 ± 1.9) at 1 month (2.9 ± 1.9, P < 0.001), 3 months (3.0 ± 2.3, P < 0.001), 6 months (3.0 ± 2.1, P < 0.001), and 9 months (3.0 ± 2.4, P < 0.001) postprocedure. Nasal congestion and rhinorrhea subscores improved significantly at all time points (P < 0.001). Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups. RQLQ significantly improved over pretreatment baseline (3.0 ± 1.0) at 3 months (1.5 ± 1.0, P < 0.001), and all RQLQ subdomains demonstrated improvement. Of 54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use. Twenty-nine adverse effects were reported, including headache, epistaxis, and sinusitis.
CONCLUSION


Cryoablation of the PNN for chronic rhinitis is safe and can result in relief of nasal symptoms and improvements in quality of life.
LEVEL OF EVIDENCE


4 Laryngoscope, 130: 1877-1884, 2020.",2020,"Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups.","['98 adult patients at six U.S. centers with chronic allergic and nonallergic rhinitis', 'rhinitis', '54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use', 'Ninety-eight procedures (100%) were successfully completed']","['posterior nasal nerve (PNN', 'intranasal ipratropium', 'PNN cryoablation', 'Cryosurgical ablation']","['Reflective Total Nasal Symptom Score (rTNSS', 'quality of life', 'efficacy and safety', 'headache, epistaxis, and sinusitis', 'rTNSS', 'RQLQ', 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ', 'Nasal congestion and rhinorrhea subscores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0037199', 'cui_str': 'Sinus Infections'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}]",98.0,0.0455949,"Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Chang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Hwang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28301']
801,31982649,Adherence-adjustment in placebo-controlled randomized trials: An application to the candesartan in heart failure randomized trial.,"BACKGROUND


The per-protocol effect provides important information in randomized trials with incomplete adherence. Yet, because valid estimation typically requires adjustment for prognostic factors that predict adherence, per-protocol effect estimates are often met with skepticism. In placebo-controlled trials, however, the validity of adjustment can be indirectly verified by demonstrating no association between adherence and the outcome among the placebo arm. Here, we describe a two-stage procedure in which we first adjust for time-varying adherence in the placebo arm and then use a similar procedure to estimate the per-protocol effect.
METHODS


We use the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) randomized trial. First, we compare adherers versus non-adherers in the placebo arm, adjusting for pre- and post-randomization variables. Second, we use models validated in the placebo arm to estimate the per-protocol effect of adherence to candesartan versus placebo in the full trial.
FINDINGS


We successfully estimated no association between adherence and mortality in the placebo arm; hazard ratio: 0.91 (95% CI: 0.51, 2.52). We then estimated the per-protocol effect under two sets of protocol-defined stopping criteria after adjustment for post-randomization confounders. The mortality hazard ratio estimates ranged from 0.91 to 0.93 for the per-protocol effect estimates, similar to the intention-to-treat effect estimates.
INTERPRETATION


Adherence adjustment in the CHARM trial is feasible when appropriate assumptions about missing data and confounding are made. These assumptions cannot be verified but can be supported through the use of placebo-arm adherence assessment.",2020,"We successfully estimated no association between adherence and mortality in the placebo arm; hazard ratio: 0∙91 (95% CI: 0∙51, 2∙52).",[],"['placebo', 'Candesartan', 'candesartan versus placebo', 'candesartan']","['adherence and mortality', 'mortality hazard ratio estimates']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.666194,"We successfully estimated no association between adherence and mortality in the placebo arm; hazard ratio: 0∙91 (95% CI: 0∙51, 2∙52).","[{'ForeName': 'Eleanor J', 'Initials': 'EJ', 'LastName': 'Murray', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Boston University School of Public Health, Boston, MA, USA. Electronic address: ejmurray@bu.edu.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': 'Department of Non-invasive Cardiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Bradi', 'Initials': 'B', 'LastName': 'Granger', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': 'Department of Non-invasive Cardiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Harvard-MIT Division of Health Sciences and Technology, Boston, MA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105937']
802,31818699,"Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study.","BACKGROUND


Many patients with Parkinson's disease have potentially disabling off episodes that are not predictably responsive to levodopa. In this study, we assessed the safety and efficacy of apomorphine sublingual film as an on-demand therapy for off episodes in patients with Parkinson's disease.
METHODS


This randomised, double-blind, placebo-controlled study was done by movement disorder specialists at 32 sites in the USA and one in Canada. Patients with Parkinson's disease who had 2 h or more of off time per day with predictable morning off periods, were responsive to levodopa, and were on stable doses of anti-parkinsonian medication were eligible. In an open-label titration phase, increasing doses of apomorphine sublingual film (10-35 mg) were administered until a tolerable full on response was achieved. Patients were then randomly assigned (1:1) with an interactive web-response system to receive the effective dose of apomorphine sublingual film or matching placebo in a 12-week, double-blind maintenance phase. Randomisation was not stratified, and the block size was four. All patients and study personnel were masked to treatment assignments. The primary endpoint was the in-clinic change from predose to 30 min post-dose in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 (motor) score at week 12, analysed on a modified intention-to-treat population by use of a mixed-effect model for repeated measures. Safety analyses were done on all enrolled patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT02469090.
FINDINGS


Between June 18, 2015, and Dec 11, 2017, 109 patients were enrolled and randomly assigned to receive apomorphine sublingual film (n=54) or placebo (n=55). All patients received the assigned study treatment, and 34 (63%) of 54 patients receiving apomorphine sublingual film and 46 (84%) of 55 receiving placebo completed the study. Least squares mean (SE) change from predose to 30 min post-dose in MDS-UPDRS part 3 score at week 12 was -11·1 (SE 1·46, 95% CI -14·0 to -8·2) with apomorphine sublingual film and -3·5 (1·29, -6·1 to -0·9) with placebo (difference -7·6, SE 1·96, 95% CI -11·5 to -3·7; p=0·0002). Mild-to-moderate oropharyngeal events were the most common side-effect, reported in 17 (31%) of 54 patients receiving apomorphine sublingual film and in four (7%) of 55 patients receiving placebo, leading to treatment discontinuation in nine (17%) patients treated with apomorphine and in one (2%) patient treated with placebo. Other treatment-emergent adverse events were transient nausea (in 15 [28%] patients receiving apomorphine sublingual film), somnolence (seven [13%]), and dizziness (five [9%]). Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders were infrequent (prevalence ≤2% of all patients) or did not occur. One patient treated with apomorphine sublingual film (with known cardiac risk factors) had a fatal cardiac arrest.
INTERPRETATION


Although nearly a third of patients discontinued treatment primarily because of oropharyngeal side-effects, apomorphine sublingual film provided an efficacious, on-demand treatment for off episodes for most patients with Parkinson's disease in this trial. The long-term safety and efficacy of apomorphine sublingual film are currently being investigated.
FUNDING


Cynapsus Therapeutics and Sunovion.",2020,"Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders were infrequent (prevalence ≤2% of all patients) or did not occur.","[""Parkinson's disease"", ""Patients with Parkinson's disease who had 2 h or more of off time per day with predictable morning off periods, were responsive to levodopa, and were on stable doses of anti-parkinsonian medication were eligible"", ""patients with Parkinson's disease"", 'enrolled patients who received at least one dose of study medication', 'movement disorder specialists at 32 sites in the USA and one in Canada', 'All patients received the assigned study treatment, and 34 (63%) of 54 patients receiving', 'Between June 18, 2015, and Dec 11, 2017, 109 patients']","['apomorphine sublingual film', 'apomorphine sublingual film or matching placebo', 'apomorphine', 'placebo', 'Apomorphine sublingual film']","['transient nausea', 'dizziness', 'fatal cardiac arrest', ""clinic change from predose to 30 min post-dose in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 (motor) score"", 'safety and efficacy', 'Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders', 'somnolence', 'Mild-to-moderate oropharyngeal events']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439568', 'cui_str': 'Post-dose (qualifier value)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0021122', 'cui_str': 'Impulse Control Disorders'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",109.0,0.374256,"Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders were infrequent (prevalence ≤2% of all patients) or did not occur.","[{'ForeName': 'C Warren', 'Initials': 'CW', 'LastName': 'Olanow', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Clintrex, Sarasota, FL, USA. Electronic address: warren.olanow@clintrex.com.'}, {'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Factor', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'Department of Neurology, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Holly A', 'Initials': 'HA', 'LastName': 'Shill', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'University of Kansas Medical Center, University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clintrex, Sarasota, FL, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sciarappa', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30396-5']
803,32406581,"Effect of a water, sanitation and hygiene program on handwashing with soap among household members of diarrhoea patients in healthcare facilities in Bangladesh: a cluster-randomised controlled trial of the CHoBI7 mobile health program.","OBJECTIVE


The Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) is a water treatment and handwashing with soap intervention for diarrhoea patients and their household members which is initially delivered in a healthcare facility setting. This study evaluated the effectiveness of CHoBI7 program delivery in increasing handwashing with soap in a healthcare facility setting among diarrhoea patients and their household members.
METHODS


A randomised controlled trial of the CHoBI7 program was conducted among 404 diarrhoea patients and their accompanying household members in healthcare facilities in Dhaka, Bangladesh. The 'Standard Message' Arm received the standard message given in Bangladesh to diarrhoea patients on the use of oral rehydration solution. The 'Health Facility Visit + Soapy Water' Arm received the standard message, the CHoBI7 communication module delivered bedside to the patient; and a soapy water bottle in the healthcare facility. The 'Health Facility Visit + Handwashing Station' Arm received this same intervention plus a small plastic handwashing station. Within 24 h of intervention delivery, three-hour structured observation of handwashing practices at stool/vomit- and food-related events (key events) was conducted in healthcare facilities of diarrhoea patients and their accompanying household members.
RESULTS


Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Soapy Water Arm (51% vs. 25 %) (Odds Ratio: 3.02; (95% Confidence Interval (CI): 1.41, 6.45) and the Health Facility Visit + Handwashing Station Arm (58% vs. 25%) OR: 4.12; (95% CI: 1.86, 9.14).
CONCLUSION


These findings demonstrate that delivery of the CHoBI7 communication module and provision of a soapy water bottle to diarrhoea patients and their accompanying household members presents a promising approach to increase handwashing with soap among this high risk population in a healthcare facility setting in Bangladesh.",2020,"Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Handwashing Station Arm (58% vs. 25%)","['404 diarrhea patients and their accompanying household members in health facilities in Dhaka, Bangladesh', 'Handwashing with Soap among Household Members of Diarrhea Patients in Health Facilities in Bangladesh']","['CHoBI7 program delivery', 'Water, Sanitation, and Hygiene Program', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7', 'CHoBI7 program']",['Health Facility Visit + Soapy Water Arm'],"[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",404.0,0.0475223,"Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Handwashing Station Arm (58% vs. 25%)","[{'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul Islam', 'Initials': 'MSI', 'LastName': 'Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon K', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Sharika', 'Initials': 'S', 'LastName': 'Nuzhat', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'M Tasdik', 'Initials': 'MT', 'LastName': 'Hasan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13416']
804,31625483,Computer-based tailored dietary counselling improves the nutrient adequacy of the diet of French pregnant women: a randomised controlled trial.,"During pregnancy, mothers-to-be should adapt their diet to meet increases in nutrient requirements. Pregnant women appear to be keener to adopt healthier diets, but are not always successful. The objective of the present study was to determine whether a guided, stepwise and tailored dietary counselling programme, designed using an optimisation algorithm, could improve the nutrient adequacy of the diet of pregnant women, beyond generic guidelines. Pregnant women (n 80) who attended Notre-Dame-de-Bon-Secours Maternity Clinic were randomly allocated to the control or intervention arm. Dietary data were obtained twice from an online 3-d dietary record. The nutrient adequacy of the diet was calculated using the PANDiet score, a 100-point diet quality index adapted to the specific nutrient requirements for pregnancy. Women were supplied with generic dietary guidelines in a reference booklet. In the intervention arm, they also received nine sets of tailored dietary advice identified by an optimisation algorithm as best improving their PANDiet score. Pregnant women (n 78) completed the 12-week dietary follow-up. Initial PANDiet scores were similar in the control and intervention arms (60·4 (sd 7·3) v. 60·3 (sd 7·3), P = 0·92). The PANDiet score increased in the intervention arm (+3·6 (sd 9·3), P = 0·02) but not in the control arm (-0·3 (sd 7·3), P = 0·77), and these changes differed between arms (P = 0·04). In the intervention arm, there were improvements in the probabilities of adequacy for α-linolenic acid, thiamin, folate and cholesterol intakes (P < 0·05). Tailored dietary counselling using a computer-based algorithm is more effective than generic dietary counselling alone in improving the nutrient adequacy of the diet of French women in mid-pregnancy.",2020,"In the intervention arm, there were improvements in the probabilities of adequacy for ALA, thiamin, folate and cholesterol intakes (P<0.05).Tailored dietary counseling using a computer-based algorithm is more effective than generic dietary counseling alone in improving the nutrient adequacy of the diet of French women in mid-pregnancy.","['French pregnant women', 'Pregnant women', 'pregnant women, beyond generic guidelines.80 pregnant women who attended Notre-Dame-de-Bon-Secours Maternity Clinic']","['nine sets of tailored dietary advice identified by an optimization algorithm', 'Computer-based tailored dietary counseling', 'guided, stepwise and tailored dietary counseling program']","['PANDiet score', 'probabilities of adequacy for ALA, thiamin, folate and cholesterol intakes', 'Initial PANDiet scores']","[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0112088', 'cui_str': 'DAME'}, {'cui': 'C1274026', 'cui_str': 'Maternity clinic'}]","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.0574956,"In the intervention arm, there were improvements in the probabilities of adequacy for ALA, thiamin, folate and cholesterol intakes (P<0.05).Tailored dietary counseling using a computer-based algorithm is more effective than generic dietary counseling alone in improving the nutrient adequacy of the diet of French women in mid-pregnancy.","[{'ForeName': 'Clélia M', 'Initials': 'CM', 'LastName': 'Bianchi', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mariotti', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'Global Nutrition Department, Danone Nutricia Research, Centre Daniel Carasso, RD 128, 91737 Palaiseau Cedex, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Journet', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Yaëlle', 'Initials': 'Y', 'LastName': 'Stehr', 'Affiliation': 'Notre Dame de Bon Secours Maternity Unit, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Beaussier', 'Affiliation': 'Clinical Research Center, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Fournier', 'Affiliation': 'Clinical Research Center, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dervaux', 'Affiliation': 'UMR MIA-Paris, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Cohen-Tanuggi', 'Affiliation': 'UMR MIA-Paris, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Reulet', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Eric O', 'Initials': 'EO', 'LastName': 'Verger', 'Affiliation': 'NUTRIPASS, IRD, Université de Montpellier, SupAgro, 34000 Montpellier, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Azria', 'Affiliation': 'Notre Dame de Bon Secours Maternity Unit, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Huneau', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}]",The British journal of nutrition,['10.1017/S0007114519002617']
805,31960719,Combination of Epidural Blockade and Parecoxib in Enhanced Recovery After Gastrointestinal Surgery.,"OBJECTIVE


To investigation effects of the combination use of epidural blockade and parecoxib in postoperative recovery of colorectal cancer (CRC) patients.
METHODS


The present prospective single-blinded study included 186 CRC patients who received radical resection during April 2016 to December 2017. All patients were randomized into 3 different groups, the epidural blockade group, the combined-group with both epidural blockade and pre-intravenous injection of parecoxib, and the control group. The mean operative time, bleeding volume, the first out of bed activity time and hospital stay time were recorded. The mini-mental state examination (MMSE) score and Ramsay score were measured for cognitive function and the Visual Analog Score (VAS) was determined for the pain condition.
RESULTS


The surgery time for the control group was significantly shorter than the other 2 groups ( P  < 0.05). The VAS scores were significantly lower in both the combined group and the epidural blockade group when compared with the control group and were dramatically lower in the combined group than the others 2 groups (all  P  < 0.05). The first out of bed activity time and hospital stay time were the shortest in the combined group, and the control group had the longest time (all  P  < 0.05). Both the Ramsay and MMSE scores were the highest in the combination group than other groups (all  P  < 0.05) and no significant difference was observed between the epidural blockade group and the control.
CONCLUSION


The combination of epidural blockade and parecoxib could enhance the recovery process, as well as reduce the pain for the CRC patients.",2020,"The first out of bed activity time and hospital stay time were the shortest in the combined group, and the control group had the longest time (all  P  < 0.05).","['186 CRC patients who received', 'colorectal cancer (CRC) patients', 'during April 2016 to December 2017']","['epidural blockade', 'radical resection', 'Epidural Blockade and Parecoxib', 'parecoxib', 'epidural blockade and parecoxib', 'combined-group with both epidural blockade and pre-intravenous injection of parecoxib']","['mini-mental state examination (MMSE) score and Ramsay score', 'Ramsay and MMSE scores', 'VAS scores', 'cognitive function and the Visual Analog Score (VAS', 'longest time', 'mean operative time, bleeding volume, the first out of bed activity time and hospital stay time', 'pain', 'bed activity time and hospital stay time', 'surgery time']","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}]","[{'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",186.0,0.0257619,"The first out of bed activity time and hospital stay time were the shortest in the combined group, and the control group had the longest time (all  P  < 0.05).","[{'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Clinic, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}, {'ForeName': 'Bingqian', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': 'Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Ayibuta', 'Initials': 'A', 'LastName': 'Yashengaili', 'Affiliation': 'Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Xuebin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2019.1690601']
806,31644511,Laryngoscopic techniques modulate anaesthesiologists' perception of halitosis in patients: A randomised controlled trial.,"BACKGROUND


Perception of halitosis in patients during intubation is a common and additional stressor for anaesthesiologists and may lead to potential health risks.
OBJECTIVES


We hypothesised that intubation with videolaryngoscopy could help reduce the anaesthesiologists' perception of patients' oral malodor during intubation.
DESIGN


A single-blinded, randomised controlled trial.
SETTING


Single centre general hospital, Guangdong Province, China.
PARTICIPANTS


A total of 440 patients who underwent intubation under general anaesthesia for elective surgery, aged 18 to 60 years old, American Society of Anaesthesiologists class I to III, without upper airway abnormality or airway infection were enrolled.
INTERVENTION


Patients were randomly assigned to receive either UE videolaryngoscopy (UE) or Macintosh's direct laryngoscopy (Macintosh) group. All intubations were performed by one of six very experienced anaesthesiologists.
MAIN OUTCOME MEASURES


The patient's oral odour score was measured prior to induction of anaesthesia. The anaesthesiologists' perception of the patient's oral malodor during intubation was recorded. The shortest distance from patient's mouth to the anaesthesiologist's nose (MN distance), the exertion rating and discomfort were also measured.
RESULTS


The oral malodor score did not differ in the UE and Macintosh groups prior to the induction of anaesthesia. However, the incidence of the anaesthesiologists' perception of halitosis during intubation was significantly lower in the UE group compared with the Macintosh group (P < 0.001). Similarly, the MN distance was significantly greater in the UE group compared with the Macintosh group (P < 0.001). The first-attempt success rate was higher in the UE group compared to the Macintosh group (P < 0.001). However, the exertion scores were considerably higher in the Macintosh group. After intubation, anaesthesiologists experienced more waist and shoulder discomfort with the Macintosh than the UE technique of intubation.
CONCLUSION


Compared with direct laryngoscopy, videolaryngoscopy might reduce the anaesthesiologists' perception of the patients' oral malodor, help improve first-attempt success rate, as well as alleviate the anaesthesiologists' waist and shoulder discomfort.
TRIAL REGISTRATION


Clinicaltrials.gov (ChiCTR-IOR-15007038).",2019,The oral malodor score did not differ in the UE and Macintosh groups prior to the induction of anaesthesia.,"['A total of 440 patients who underwent intubation under general anaesthesia for elective surgery, aged 18 to 60 years old, American Society of Anaesthesiologists class I to III, without upper airway abnormality or airway infection were enrolled', 'Single centre general hospital, Guangdong Province, China', 'halitosis in patients', ""patients' oral malodor during intubation""]","['videolaryngoscopy', 'Laryngoscopic techniques', 'direct laryngoscopy, videolaryngoscopy', ""UE videolaryngoscopy (UE) or Macintosh's direct laryngoscopy (Macintosh) group""]","['success rate', 'oral malodor score', 'exertion rating and discomfort', 'waist and shoulder discomfort', 'exertion scores', ""anaesthesiologists' perception of halitosis during intubation"", 'MN distance']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0429689', 'cui_str': 'Exertion rating (staging scale)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C1096593', 'cui_str': 'Shoulder discomfort'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",440.0,0.0872739,The oral malodor score did not differ in the UE and Macintosh groups prior to the induction of anaesthesia.,"[{'ForeName': 'Chaojin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'Hei', 'Affiliation': ''}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': ''}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Rongzong', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Chulian', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Shen', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001115']
807,29847188,"Low-frequency vibrotherapy considerably improves the effectiveness of manual lymphatic drainage (MLD) in patients with lipedema: A two-armed, randomized, controlled pragmatic trial.","Purpose : Although the exact prevalence of lipedema is unknown the number of women suffering from this condition is ever-growing. When treated conservatively, manual lymphatic drainage is regarded the gold standard. However, the rate of its effectiveness varies considerably with some women showing minimal to no improvement depending on severity of the disease and medical history.  Methods : Thirty female patients diagnosed with lipedema stage 2-3 referred to physiotherapeutic treatment were randomly allocated to either six treatments of MLD or to six treatments of combined MLD and vibrotherapy treatment. Outcome parameters were the volume of lipedema at four locations of either the lower ( n  = 29) or the upper extremities ( n  = 1), as well as quality of life.  Findings : A very large superiority of effectiveness was found for the combined treatment. Reduction of the sizes of lipedema varied between 1.1 <  d  < 3.2. These patients' quality of life was also considerably better ( d  = 1.0).  Conclusions : Combining MLD with vibrotherapy treatment drastically enhances the effectiveness of treating lipedema.",2020,A very large superiority of effectiveness was found for the combined treatment.,"['Thirty female patients diagnosed with lipedema stage 2-3 referred to physiotherapeutic treatment', 'patients with lipedema']","['manual lymphatic drainage (MLD', 'combined MLD and vibrotherapy treatment', 'MLD']","['effectiveness of treating lipedema', 'sizes of lipedema', 'quality of life', 'volume of lipedema at four locations of either the lower (n\xa0=\xa029) or the upper extremities']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0398370', 'cui_str': 'Lipoedemas'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0556834', 'cui_str': 'Manual Lymphatic Drainage'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic Leukoencephalopathy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0398370', 'cui_str': 'Lipoedemas'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",30.0,0.0449983,A very large superiority of effectiveness was found for the combined treatment.,"[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Schneider', 'Affiliation': 'RECON - Research and Consulting, Freiburg, Germany.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1479474']
808,31923471,"Memory advancement by intranasal insulin in type 2 diabetes (MemAID) randomized controlled clinical trial: Design, methods and rationale.","BACKGROUND


Type 2 diabetes mellitus (T2DM) accelerates brain aging and increases the risk for dementia. Insulin is a key neurotrophic factor in the brain, where it modulates energy metabolism, neurovascular coupling, and regeneration. Impaired insulin-mediated brain signaling and central insulin resistance may contribute to cognitive and functional decline in T2DM. Intranasal insulin (INI) has emerged as a potential therapy for treating T2DM-related cognitive impairment.
METHODS/DESIGN


Ongoing from 2015, a prospective, two-center, randomized, double-blind, placebo-controlled trial of 210 subjects (120 T2DM and 90 non-diabetic older adults) randomized into four treatment arms (60 T2DM-INI, 60 T2DM-Placebo, 45 Control-INI, and 45 Control-Placebo) evaluating the long-term effects of daily intranasal administration of 40 International Units (IU) of human insulin, as compared to placebo (sterile saline) over 24 weeks and 24 weeks of post-treatment follow-up. Study outcomes are: 1) long-term INI effects on cognition, daily functionality, and gait speed; 2) identifying a clinically relevant phenotype that predicts response to INI therapy; 3) long-term safety.
CONCLUSION


This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia. Trial Registration NCT02415556.",2020,"This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia.","['type 2 diabetes (MemAID', 'older people with T2DM and non-diabetic controls', '210 subjects (120 T2DM and 90 non-diabetic older adults']","['daily intranasal administration of 40 International Units (IU) of human insulin, as compared to placebo (sterile saline', 'intranasal insulin', 'placebo', 'Memory advancement by intranasal insulin', 'T2DM-Placebo, 45 Control-INI, and 45 Control-Placebo', 'Intranasal insulin (INI']","['memory and cognition', '1) long-term INI effects on cognition, daily functionality, and gait speed; 2) identifying a clinically relevant phenotype that predicts response to INI therapy; 3) long-term safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001560', 'cui_str': 'Drug Administration, Intranasal'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",210.0,0.477211,"This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Galindo-Mendez', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Trevino', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGlinchey', 'Affiliation': 'Translational Research Center for TBI and Stress Disorders (TRACTS), Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fortier', 'Affiliation': 'Translational Research Center for TBI and Stress Disorders (TRACTS), Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lioutas', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': ""Autonomic Laboratory, Department of Neurology, Brigham and Women's Faulkner Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA; Department of Medicine, Boston VA Healthcare System, Harvard Medical School, Boston, MA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. Electronic address: vnovak@bidmc.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105934']
809,31944812,Better than my past self: Temporal comparison raises children's pride without triggering superiority goals.,"Western societies offer children many opportunities for downward social comparisons (i.e., comparing oneself favorably to others). Such comparisons make children feel proud of themselves but could inadvertently trigger a desire to be superior to others. How can children be made to feel proud without triggering a desire for superiority? We hypothesized that downward temporal comparisons (i.e., comparing one's current self favorably to one's past self) can make children feel proud and give them a sense of insight and progress, without triggering a desire for superiority. We randomly assigned 583 children ( M age  = 11.65,  SD  = 1.92) to engage in social comparisons (downward or upward), temporal comparisons (downward or upward), or no comparison. As hypothesized, downward social and temporal comparisons both made children feel proud, but only temporal comparisons did so without triggering superiority goals. Relative to social comparisons, temporal comparisons gave children a sense of progress and insight. These comparison effects were similar across middle-to-late childhood (ages 8-10), early adolescence (ages 11-13), and middle adolescence (ages 14-16). Collectively, our findings suggest that social comparisons contribute a competitive interpersonal orientation marked by a desire for superiority. Temporal comparisons, in contrast, shift children's goals away from being better than others toward being better than their own past selves. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"As hypothesized, downward social and temporal comparisons both made children feel proud, but only temporal comparisons did so without triggering superiority goals.","['583 children ( M age  = 11.65,  SD  = 1.92) to', 'early adolescence (ages 11-13), and middle adolescence (ages 14-16']","['engage in social comparisons (downward or upward), temporal comparisons (downward or upward), or no comparison']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}]",[],583.0,0.079534,"As hypothesized, downward social and temporal comparisons both made children feel proud, but only temporal comparisons did so without triggering superiority goals.","[{'ForeName': 'Çisem', 'Initials': 'Ç', 'LastName': 'Gürel', 'Affiliation': 'Research Institute of Child Development and Education.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Brummelman', 'Affiliation': 'Research Institute of Child Development and Education.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Sedikides', 'Affiliation': 'Center for Research on Self and Identity.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'Overbeek', 'Affiliation': 'Research Institute of Child Development and Education.'}]",Journal of experimental psychology. General,['10.1037/xge0000733']
810,31650500,Evaluation of hyperoxia-induced hypercapnia in obese patients after cardiac surgery: a randomized crossover comparison of conservative and liberal oxygen administration.,"PURPOSE


Recent studies on patients with stable obesity-hypoventilation syndrome have raised concerns about hyperoxia-induced hypercapnia in this population. This study aimed to evaluate whether a higher oxygen saturation target would increase arterial partial pressure of carbon dioxide (PaCO 2)  in obese patients after coronary artery bypass grafting surgery (CABG).
METHODS


Obese patients having CABG were recruited. With a randomized crossover design, we compared two oxygenation strategies for 30 min each, immediately after extubation: a peripheral oxygen saturation (SpO 2 ) target of ≥ 95% achieved with manual oxygen titration (liberal) and a SpO 2  target of 90% achieved with FreeO 2 , an automated oxygen titration device (conservative). The main outcome was end-of-period arterial PaCO 2 .
RESULTS


Thirty patients were included. Mean (standard deviation [SD]) body mass index (BMI) was 34 (3) kg·m -2  and mean (SD) baseline partial pressure of carbon dioxide (PCO 2 ) was 40.7 (3.1) mmHg. Mean (SD) end-of-period PaCO 2  was 42.0 (5.4) mmHg in the conservative period, compared with 42.6 (4.6) mmHg in the liberal period [mean difference - 0.6 (95% confidence interval - 2.2 to 0.9) mmHg; P = 0.4]. Adjusted analysis for age, BMI, narcotics, and preoperative PaCO 2  did not substantively change the results. Fourteen patients were retainers, showing an elevation in mean (SD) PaCO 2  in the liberal period of 3.3 (4.1) mmHg. Eleven patients had the opposite response, with a mean (SD) end-of-period PaCO 2  decrease of 1.8 (2.2) mmHg in the liberal period. Five patients had a neutral response.
CONCLUSION


This study did not show a clinically important increase in PaCO 2  associated with higher SpO 2  values in this specific population of obese patients after CABG. Partial pressure of carbon dioxide increased with liberal oxygen administration in almost half of the patients, but no predictive factor was identified.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02917668); registered 25 September, 2016.",2020,"Partial pressure of carbon dioxide increased with liberal oxygen administration in almost half of the patients, but no predictive factor was identified.
","['Obese patients having CABG were recruited', 'patients with stable obesity-hypoventilation syndrome', 'Fourteen patients were retainers, showing an elevation in mean (SD) PaCO 2  in the liberal period of 3.3 (4.1) mmHg', 'obese patients after coronary artery bypass grafting surgery (CABG', 'Eleven patients had the opposite response, with a mean (SD) end-of-period PaCO 2  decrease of 1.8 (2.2) mmHg in the liberal period', 'Five patients had a neutral response', 'Thirty patients were included', 'obese patients after cardiac surgery']","['carbon dioxide (PaCO 2', 'hyperoxia-induced hypercapnia', 'conservative and liberal oxygen administration', 'peripheral oxygen saturation (SpO 2 )\xa0target of ≥ 95% achieved with manual oxygen titration (liberal) and a SpO 2 \xa0target of 90% achieved with FreeO 2 , an automated oxygen titration device (conservative']","['Partial pressure of carbon dioxide', 'Mean (SD) end-of-period PaCO 2', 'Mean (standard deviation [SD]) body mass index (BMI', 'SD) baseline partial pressure of carbon dioxide (PCO 2 ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0031880', 'cui_str': 'Obesity Hypoventilation Syndrome'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",30.0,0.46155,"Partial pressure of carbon dioxide increased with liberal oxygen administration in almost half of the patients, but no predictive factor was identified.
","[{'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Denault', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Research Center, 2725 Chemin Ste-Foy, Quebec, QC, G1V 4G5, Canada. marie-helene.denault.1@ulaval.ca.'}, {'ForeName': 'Carolanne', 'Initials': 'C', 'LastName': 'Ruel', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Research Center, 2725 Chemin Ste-Foy, Quebec, QC, G1V 4G5, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Research Center, 2725 Chemin Ste-Foy, Quebec, QC, G1V 4G5, Canada.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bouchard', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Research Center, 2725 Chemin Ste-Foy, Quebec, QC, G1V 4G5, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Simard', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Research Center, 2725 Chemin Ste-Foy, Quebec, QC, G1V 4G5, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lellouche', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Research Center, 2725 Chemin Ste-Foy, Quebec, QC, G1V 4G5, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01500-x']
811,31721089,New insights into weight management by orlistat in comparison with cinnamon as a natural lipase inhibitor.,"BACKGROUND AND OBJECTIVES


Orlistat which is taken by obese patients may present some therapeutic assistance through its inhibition of lipase activity. Otherwise, a natural lipase inhibitor as cinnamon is widely used traditional medicine to decrease cholesterol and body weight. The current study aimed to investigate the weight management of orlistat in comparison with cinnamon through different obesity related targets.
METHODS


Subjects were divided into: Group 1: subjects received cinnamon capsules for 60 days. Group 2: subjects were received orlistat twice daily for 30 days, then once daily for another 30 days. Blood samples were collected at baseline and after 2 months.
RESULTS


Both orlistat and cinnamon groups showed a significant reduction in BMI, lipid profile, and lipase activity compared with baseline. Orlistat group showed significant elevation (p < 0.001) in glucagon, insulin-degrading enzyme (IDE) and dopamine level concomitant with the decrease of serum glutamate compared with baseline level of the same group and cinnamon group. However, cinnamon reduced serum insulin level and insulin resistance (IR) compared with baseline level of the same group and orlistat group.
CONCLUSIONS


Orlistat can be used in weight management not only for its pancreatic lipase inhibition but also, due to its indirect appetite reduction effect through elevated glucagon, IDE and dopamine levels and its inhibitory effect on glutamate neurotransmitter, whereas, cinnamon improves BMI and glycaemic targets.",2020,"Orlistat group showed significant elevation (p < 0.001) in glucagon, insulin-degrading enzyme (IDE) and dopamine level concomitant with the decrease of serum glutamate compared with baseline level of the same group and cinnamon group.","['Subjects were divided into: Group 1: subjects received', 'obese patients']","['orlistat', 'Orlistat', 'cinnamon capsules']","['glucagon, insulin-degrading enzyme (IDE) and dopamine level concomitant', 'BMI, lipid profile, and lipase activity', 'Blood samples', 'serum insulin level and insulin resistance (IR', 'serum glutamate', 'cholesterol and body weight']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0076275', 'cui_str': 'orlistat'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0201984,"Orlistat group showed significant elevation (p < 0.001) in glucagon, insulin-degrading enzyme (IDE) and dopamine level concomitant with the decrease of serum glutamate compared with baseline level of the same group and cinnamon group.","[{'ForeName': 'Naglaa F', 'Initials': 'NF', 'LastName': 'Khedr', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt. Naglaa.khedr@pharm.tanta.edu.eg.'}, {'ForeName': 'Abla M', 'Initials': 'AM', 'LastName': 'Ebeid', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Delta University for Science and Technology, Gamasaa, Egypt.'}, {'ForeName': 'Rania M', 'Initials': 'RM', 'LastName': 'Khalil', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Delta University for Science and Technology, Gamasaa, Egypt.'}]",Endocrine,['10.1007/s12020-019-02127-0']
812,31927647,"""Comparative study between the efficacy of fractional CO2 laser, Q-switched Nd:YAG laser (1064 nm), and both types in treatment of keratosis pilaris"".","The aim of this study was to assess and compare the efficacy of fractional CO2 laser, Q-switched Nd:YAG laser (1064 nm), and their combined use in treatment of keratosis pilaris. The study included twenty female patients. For each patient, three areas were randomly assigned to treatment by either fractional CO2 laser (area A) or Q-switched laser (1064 nm) (area C), or both types of laser (area B). All patients were assessed by digital photography at baseline and 1 month after the last session. Assessment was done by two non-blinded and two blinded investigators (blinded investigators do not know which area is treated with which machine and non-blinded knows). Patients reported the degree of satisfaction or any adverse effects also after 1 month from the last session. The three treatment modalities led to overall improvement in the KP lesions. According to patients' score and investigator two, area B showed statistically significant improvement compared to areas A and C (p=0.001 and p=0.039, respectively). The first blinded investigators' assessment revealed that there was statistically significant improvement in area C compared to A and B (p = 0.023). The assessment of both investigator one and the second blinded investigator revealed that there was improvement in the three areas with no statistically significant difference between them. Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.",2020,Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.,"['twenty female patients', 'keratosis pilaris']","['fractional CO2 and Q-switched Nd:YAG laser', 'fractional CO2 laser (area A) or Q-switched laser', 'fractional CO2 laser, Q-switched Nd:YAG laser']",['degree of satisfaction or any adverse effects'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0870082', 'cui_str': 'Hyperkeratosis of skin'}]","[{'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1956123', 'cui_str': 'Q-Switched Lasers'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",20.0,0.0294406,Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.,"[{'ForeName': 'Rehab Mohamed', 'Initials': 'RM', 'LastName': 'Sobhi', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt. sobhirehab@yahoo.com.'}, {'ForeName': 'Nada Adel Hassan', 'Initials': 'NAH', 'LastName': 'Adawy', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt.'}, {'ForeName': 'Iman Sany', 'Initials': 'IS', 'LastName': 'Zaky', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt.'}]",Lasers in medical science,['10.1007/s10103-020-02956-w']
813,31944378,The plasma pharmacokinetics of fosfomycin and metronidazole after intraperitoneal administration in patients undergoing appendectomy for uncomplicated appendicitis.,"We aimed to investigate the pharmacokinetics of fosfomycin and metronidazole after intraperitoneal administration of the combination of fosfomycin and metronidazole in patients undergoing laparoscopic appendectomy for uncomplicated appendicitis. We included eight otherwise healthy men undergoing laparoscopic appendectomy. The trial treatment was administered at the end of the surgical procedure and left in the abdominal cavity. Trial drugs consisted of 4 g fosfomycin and 1 g metronidazole in a total volume of 500.2 mL. Blood samples were collected prior to and ½, 1, 2, 4, 8, 12 and 24 h after administration. High-performance liquid chromatography-mass spectrometry was used for the measurement of plasma concentrations, and pharmacokinetic calculations were undertaken. Antimicrobial susceptibility testing was undertaken on isolates from intraoperatively collected specimens. The median maximal concentration for fosfomycin in plasma was 104.4 mg/L, median time point for the maximal concentration was 1.5 h, median half-life 3.0 h, and median area under the curve 608 mg*h/L. The median maximal concentration for metronidazole in plasma was 13.6 mg/L, median time point for the maximal concentration was 2.0 h, median half-life 7.3 h, and median area under the curve was 164 mg*h/L. All aerobic bacteria were susceptible to fosfomycin, and all anaerobes were susceptible to metronidazole. Plasma concentrations of fosfomycin and metronidazole were in line with concentrations reported from pharmacokinetic studies after intravenous administration and were within therapeutic ranges.",2020,"The median maximal concentration for fosfomycin in plasma was 104.4 mg/l, median time point for the maximal concentration was 1.5 hours, median half-life 3.0 hours, and median area under the curve 608 mg*hours/l.","['patients undergoing appendectomy for uncomplicated appendicitis', 'eight otherwise healthy men undergoing', 'patients undergoing laparoscopic appendectomy for uncomplicated appendicitis']","['laparoscopic appendectomy', 'metronidazole', 'fosfomycin and metronidazole', '4 g fosfomycin and 1 g metronidazole']","['median maximal concentration for fosfomycin in plasma', 'median maximal concentration', 'Plasma concentrations of fosfomycin and metronidazole']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]",,0.031729,"The median maximal concentration for fosfomycin in plasma was 104.4 mg/l, median time point for the maximal concentration was 1.5 hours, median half-life 3.0 hours, and median area under the curve 608 mg*hours/l.","[{'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Fonnes', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej 75, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Johan Juhl', 'Initials': 'JJ', 'LastName': 'Weisser', 'Affiliation': 'Section of Analytical Bioscience, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, DK-2100, Copenhagen E, Denmark.'}, {'ForeName': 'Barbara Juliane', 'Initials': 'BJ', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej 75, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Arpi', 'Affiliation': 'Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej 75, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej 75, DK-2730, Herlev, Denmark.'}]",Fundamental & clinical pharmacology,['10.1111/fcp.12535']
814,29496722,Calcium and vitamin D supplementation and increased risk of serrated polyps: results from a randomised clinical trial.,"OBJECTIVE


Serrated lesions such as sessile serrated adenomas or polyps (SSA/Ps) are important colorectal cancer precursors, but aetiological factors for these lesions are largely unknown. We aimed to determine the effects of calcium and vitamin D supplementation on the incidence of serrated polyps (SPs) in general and hyperplastic polyps and SSA/Ps specifically.
DESIGN


Participants with one or more adenoma at baseline were randomised to receive 1200 mg/day of elemental calcium, 1000 IU/day of vitamin D 3 , both or neither agent. Treatment continued for 3 or 5 years, when risk of polyps was determined from surveillance colonoscopy (treatment phase). Outcomes after treatment ceased were also assessed (observational phase). Adjusted risk ratios (aRRs) of SPs were determined via multivariable generalised linear models.
RESULTS


SPs were diagnosed in 565 of 2058 (27.5%) participants during the treatment phase and 329/1108 (29.7%) during the observational phase. In total, 211 SSA/Ps were identified during follow-up. In the treatment phase, there was no effect of either calcium or vitamin D on incidence of SSA/Ps. However, during the later observational phase, we observed elevated risks of SSA/Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).
CONCLUSION


In a large multicentre chemoprevention study, we found evidence that calcium and vitamin D supplementation increased the risk of SSA/Ps. This appeared to be a late effect: 6-10 years after supplementation began. These possible risks must be weighed against the benefits of calcium and vitamin D supplementation. :  Trial registration  NUMBER: NCT00153816; Results.",2019,"Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).
","['Participants with one or more adenoma at baseline', 'serrated polyps (SPs) in general and hyperplastic polyps and SSA']","['calcium or vitamin D', 'calcium and vitamin D supplementation', 'Calcium and vitamin D supplementation', 'elemental calcium, 1000 IU/day of vitamin D 3 , both or neither agent']","['risk of serrated polyps', 'risk of SSA/Ps', 'Adjusted risk ratios (aRRs) of SPs']","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0333983', 'cui_str': 'Metaplastic polyp (morphologic abnormality)'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C4255078', 'cui_str': 'SPS'}]",,0.282579,"Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).
","[{'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Crockett', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Ahnen', 'Affiliation': 'Division of Gastroenterology, University of Colorado School of Medicine, Aurora Health Care, Denver, Colorado, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Robertson', 'Affiliation': 'Division of Gastroenterology and Hepatology, VA Medical Center, White River Junction, VT & Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Anderson', 'Affiliation': 'Division of Gastroenterology and Hepatology, VA Medical Center, White River Junction, VT & Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Wallace', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Burke', 'Affiliation': 'Department of Gastroenterology, Cleveland Clinic School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Bresalier', 'Affiliation': 'Department of Gastroenterology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Snover', 'Affiliation': 'Department of Pathology, Fairview Southdale Hospital, Edina, Minnesota, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}]",Gut,['10.1136/gutjnl-2017-315242']
815,31971595,Decrease in Resting Heart Rate Measured Using Smartphone Apps to Verify Abstinence From Smoking: An Exploratory Study.,"INTRODUCTION


Verifying self-reports of smoking abstinence is challenging in studies that involve remote data collection. Resting heart rate (HR) decreases during smoking abstinence. This study assessed whether a decrease in resting HR measured using freely available smartphone apps could potentially be used to verify smoking abstinence.
METHODS


This study involved a repeated measures experimental design, with data collection in natural setting. Participants were 18 adult, daily smokers. They recorded resting HR in beats per minute (bpm) using freely available smartphone apps during five timepoints (two in the morning and three postnoon) on each of 3 days. The outcome measure was the mean of the postnoon HR recordings. The experimental condition for each of the 3 days (counterbalanced order) was as follows: (1) smoking as usual, (2) not smoking without nicotine replacement therapy (NRT), or (3) not smoking but using NRT. Abstinence was verified using expired-air carbon monoxide (CO) concentration.
RESULTS


Compared with the smoking as usual condition, mean HR was 13.4 bpm lower (95% confidence interval [CI] = 5.4 to 21.4, p = .001) in the not smoking without NRT condition and 10.4 bpm lower (95% CI = 3.1 to 17.8, p = 0.004) in the not smoking with NRT condition. There was no statistically significant difference in HR between the two not smoking conditions (p = .39). Abstinence during not smoking days without and with NRT was CO-verified in 18/18 and in 16/18 cases, respectively.
CONCLUSIONS


Self-recording of resting HR in natural setting using smartphone apps shows a reliable decrease in response to smoking abstinence and may provide a basis for remote verification in smoking cessation studies.
IMPLICATIONS


Remote verification of self-reported abstinence in smoking cessation studies remains challenging. Smoking abstinence has been shown to decrease resting HR under laboratory conditions. This study demonstrated that self-recording using freely available smartphone apps shows reliable decreases in resting HR during smoking abstinence and may provide a basis for inexpensive remote verification of smoking abstinence.",2020,There was no statistically significant difference in HR between the two not smoking conditions (p=0.39).,"['Participants were 18 adult, daily smokers']","['smoking as usual, 2) not smoking without nicotine replacement therapy (NRT), or 3) not smoking but using NRT']","['HR', 'resting HR', 'expired-air carbon monoxide (CO) concentration', 'mean of the post-noon HR recordings', 'resting heart rate', 'Resting heart rate (HR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0585020', 'cui_str': 'Noon (qualifier value)'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}]",18.0,0.0368632,There was no statistically significant difference in HR between the two not smoking conditions (p=0.39).,"[{'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Herbec', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Parker', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Harveen Kaur', 'Initials': 'HK', 'LastName': 'Ubhi', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Raupach', 'Affiliation': 'The Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa021']
816,31977324,Increased Muscle Strength Limits Postural Sway During Daily Living Activities in Total Hip Arthroplasty Patients.,"OBJECTIVE


The aim of the study was to investigate the effect of maximal strength training on postural sway after total hip arthroplasty, performed before and after a battery of physical performance tests that resemble daily living activities.
DESIGN


This study is an exploratory study based on data from a 3-mo randomized controlled trial involving 54 total hip arthroplasty patients performing maximal strength training or conventional rehabilitation. At 3, 6, and 12 mos postoperatively, postural sway was evaluated in two gait tests; ie, one test before and one test after conducting a battery of physical performance tests.
RESULTS


At 3 mos postoperatively, postural sway in the test after was significantly higher for the conventional rehabilitation group than the maximal strength training group (P = 0.045); however, there was no between-group difference at the test before (P = 0.670). Postural sway was also significantly higher in the test after compared with the test before in the conventional rehabilitation group (P < 0.001). No difference was found between the test before and test after in the maximal strength training group (P = 0.713). At 6 and 12 mos postoperatively, there were no statistically significant within- or between-group differences in postural sway.
CONCLUSIONS


Increased muscular strength limits postural sway 3 mos postoperatively in total hip arthroplasty patients after a demanding battery of physical performance tests simulating daily living activities.",2020,"At 6 and 12 months postoperatively, there were no statistically significant within- or between-group differences in postural sway.
","['total hip arthroplasty patients', 'postural sway after total hip arthroplasty (THA', '54 THA patients performing']","['MST or conventional rehabilitation (CR', 'MST', 'maximal strength training (MST']","['postural sway in the TA', 'postural sway', 'Postural sway', 'TB and TA']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",54.0,0.0278132,"At 6 and 12 months postoperatively, there were no statistically significant within- or between-group differences in postural sway.
","[{'ForeName': 'Siri B', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'From the Orthopedic Research Centre, Department of Orthopedic Surgery, Clinic of Orthopedics, Rheumatology and Dermatology, St. Olavs Hospital HF, Trondheim, Norway (SBW, OAF, JK); Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway (SBW, OAF); Department of Orthopedic Surgery, Clinic of Orthopedics, Rheumatology and Dermatology, St. Olavs Hospital HF, Trondheim, Norway (SBW, OAF, JK, VSH); Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway (VSH); and OsloMet - Oslo Metropolitan University, Faculty of Health Sciences, Institute of Nursing, Oslo, Norway (VSH).'}, {'ForeName': 'Olav A', 'Initials': 'OA', 'LastName': 'Foss', 'Affiliation': ''}, {'ForeName': 'Jomar', 'Initials': 'J', 'LastName': 'Klaksvik', 'Affiliation': ''}, {'ForeName': 'Vigdis S', 'Initials': 'VS', 'LastName': 'Husby', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001382']
817,30783724,"The Joint Tip Graft: A Joint Support for Rim, Facet and Infratip Lobule in Rhinoplasty.","BACKGROUND


The authors of this study have developed a novel graft called the 'The Joint Tip Graft' which adds support to the lateral crus, camouflages the tip grafts, supports the facet and adds volume to the nasal tip as a single graft. The aim of this study was to define and introduce the tripod graft.
METHODS


Thirty patients who underwent primary rhinoplasty at a tertiary academic center were included. Patients were randomly assigned into two groups according to the grafts used: group 1: Joint tip graft was additionally used, and group 2: Joint tip graft was not used. All patients were photographed by a photographer who is familiar with medical photography. Preoperative and postoperative sixth month photographs were taken for analysis. The brightest point of the infratip lobule and the darkest point of the facets were selected and analyzed with computer software. The luminance ratio of facet to infratip lobule was calculated to overcome light and head position differences.
RESULTS


Mean infratip luminance scores were 112.20 ± 5.72 and 109.73 ± 7.13 in groups 1 and 2, respectively (p > 0.05). Mean facet luminance scores were 101.33 ± 4.91 and 89.27 ± 5.11 in groups 1 and 2, respectively (p < 0.05). Facet/infratip luminance ratios were calculated for each group. Mean facet/infratip luminance ratios were 0.90 ± 0.01 and 0.82 ± 0.16 for groups 1 and 2, respectively (p < 0.05).
CONCLUSIONS


The joint tip graft is a novel graft that is easy to harvest and apply. It spans both of the alar cartilages, supports the facet area and creates a smooth gradual light shadow transition. Additionally, it acts as a camouflage over the tip grafts.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2019,"Mean facet luminance scores were 101.33 ± 4.91 and 89.27 ± 5.11 in groups 1 and 2, respectively (p < 0.05).","['Thirty patients who underwent primary rhinoplasty at a tertiary academic center were included', 'All patients were photographed by a photographer who is familiar with medical photography']","['IV', 'Joint tip graft']","['Mean infratip luminance scores', 'luminance ratio of facet to infratip lobule', 'Mean facet/infratip luminance ratios', 'Facet/infratip luminance ratios', 'Mean facet luminance scores']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0554179', 'cui_str': 'Photographer (occupation)'}, {'cui': 'C0431056', 'cui_str': 'Photography of patient'}]","[{'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234684', 'cui_str': 'Luminance, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}]",30.0,0.0275634,"Mean facet luminance scores were 101.33 ± 4.91 and 89.27 ± 5.11 in groups 1 and 2, respectively (p < 0.05).","[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Gode', 'Affiliation': 'Otolaryngology Department, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Goksel', 'Initials': 'G', 'LastName': 'Turhal', 'Affiliation': 'Otolaryngology Department, Ege University School of Medicine, Izmir, Turkey. gokselturhal@gmail.com.'}, {'ForeName': 'Veysel', 'Initials': 'V', 'LastName': 'Berber', 'Affiliation': 'Otolaryngology Department, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Kaya', 'Affiliation': 'Otolaryngology Department, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Karci', 'Affiliation': 'Otolaryngology Department, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Cingi', 'Affiliation': 'Otolaryngology Department, Osmangazi University School of Medicine, Eskisehir, Turkey.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01329-1']
818,31547736,CPX-351 (vyxeos) in AML.,"For decades, the standard induction for patients with acute myeloid leukemia (AML) has been the combination of cytarabine with anthracycline (7 + 3 regimen). In August 2017 the US FDA approved CPX-351 (vyxeos), a liposomal formulation of cytarabine and daunorubicin at a fixed 5:1 molar ratio, for the treatment of adults with newly diagnosed AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML (t-AML). This is the first approved treatment specifically for patients with this subgroup of AML. The approval was based on findings from a multicenter, randomized, open-label, phase III study of CPX-351 Versus 7 + 3 in patients 60-75 years old with newly diagnosed AML-MRC or t-AML. In this study CPX-351 had a higher median OS than 7 + 3 (9.56 vs 5.95 months, HR 0.69; 95% CI: 0.52 to 0.90,  p  = 0.005). In this profile, we review preclinical and clinical data, and discuss limitations and future directions with CPX-351 use in AML.",2020,"In this study CPX-351 had a higher median OS than 7 + 3 (9.56 vs 5.95 months, HR 0.69; 95% CI: 0.52 to 0.90,  p  = 0.005).","['patients 60-75\u2009years old with newly diagnosed AML-MRC or t-AML', 'patients with acute myeloid leukemia (AML', 'patients with this subgroup of AML', 'adults with newly diagnosed AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML (t-AML']","['CPX-351', 'cytarabine and daunorubicin', 'cytarabine with anthracycline']",['median OS'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0348452,"In this study CPX-351 had a higher median OS than 7 + 3 (9.56 vs 5.95 months, HR 0.69; 95% CI: 0.52 to 0.90,  p  = 0.005).","[{'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Alfayez', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi-Kashani', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1660970']
819,31926484,Body composition and neuromotor development in the year after NICU discharge in premature infants.,"BACKGROUND


Hypothesis: neuromotor development correlates to body composition over the first year of life in prematurely born infants and can be influenced by enhancing motor activity.
METHODS


Forty-six female and 53 male infants [27 ± 1.8 (sd) weeks] randomized to comparison or exercise group (caregiver provided 15-20 min daily of developmentally appropriate motor activities) completed the year-long study. Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS) were assessed.
RESULTS


AIMS at 1 year correlated with LBM (r = 0.32, p < 0.001) in the whole cohort. However, there was no effect of the intervention. LBM increased by ~3685 g (p < 0.001)); insulin-like growth factor-1 (IGF-1) was correlated with LBM (r = 0.36, p = 0.002). IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125). LBM and bone mineral density were significantly lower and IGF-1 higher in the females at 1 year.
CONCLUSIONS


We found an association between neuromotor development and LBM suggesting that motor activity may influence LBM. Our particular intervention was ineffective. Whether activities provided largely by caregivers to enhance motor activity in prematurely born infants can affect the interrelated (1) balance of growth and inflammation mediators, (2) neuromotor development, (3) sexual dimorphism, and/or (4) body composition early in life remains unknown.",2020,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","['Forty-six female and 53 male infants [27\u2009±\u20091.8 (sd) weeks', 'prematurely born infants', 'premature infants']",['randomized to comparison or exercise group (caregiver provided 15-20\u2009min daily of developmentally appropriate motor activities'],"['IL-1RA (an inflammatory biomarker', 'Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS', 'insulin-like growth factor-1 (IGF-1', 'Body composition and neuromotor development', 'motor activity', 'LBM and bone mineral density', 'LBM']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0222045'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",46.0,0.0798796,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","[{'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Cooper', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA. dcooper@hs.uci.edu.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kepes', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Candice Taylor', 'Initials': 'CT', 'LastName': 'Lucas', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Fadia', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zalidvar', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Nitzan', 'Initials': 'N', 'LastName': 'Dror', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Soliman', 'Affiliation': ""Miller Women's and Children's Hospital, Long Beach, CA, USA.""}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}]",Pediatric research,['10.1038/s41390-020-0756-2']
820,31925891,Comparative clinical study of the efficacy of intralesional MMR vaccine vs intralesional vitamin D injection in treatment of warts.,"BACKGROUND


Many therapeutic modalities were reported for the treatment of warts; however, no single treatment is completely effective.
OBJECTIVE


To evaluate the efficacy of intralesional injection of MMR vaccine vs vitamin D in treatment of warts.
PATIENTS AND METHODS


A total of 60 patients were included in the study divided into two groups. Group A received intralesional MMR vaccine into largest wart, and group B received intralesional vitamin D 3  into each lesion with maximum of five warts treated in one session. A maximum of six sessions was done every 3 weeks in both groups. Follow-up was done for 6 months for any recurrence.
RESULTS


In group A: complete response in 80%, partial response in 6.67%, minimal response in 6.67%, and no response in 6.67% of patients. About 60% of patients with multiple warts showed complete clearance of distant untreated warts. In group B: complete response in 66.7%, partial response in 6.67%, minimal response in 20%, and no response in 6.67% of patients. There was no significant difference between both groups. No recurrence was observed in both groups in the follow-up period.
CONCLUSIONS


Immunotherapy by both intralesional MMR vaccine and vitamin D 3  is simple, well-tolerated, effective, and cost-benefit modalities for the treatment of warts.",2020,"No recurrence was observed in both groups in the follow-up period.
","['warts', 'A total of 60 patients']","['intralesional MMR vaccine', 'intralesional vitamin D', 'intralesional MMR vaccine vs intralesional vitamin D injection', 'MMR vaccine vs vitamin D']","['complete clearance', 'No recurrence']","[{'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0065828', 'cui_str': 'MMR Vaccine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0280837,"No recurrence was observed in both groups in the follow-up period.
","[{'ForeName': 'Dalia R', 'Initials': 'DR', 'LastName': 'Shaldoum', 'Affiliation': 'MBBCh. Faculty of medicine, Tanta University.'}, {'ForeName': 'Ghada F R', 'Initials': 'GFR', 'LastName': 'Hassan', 'Affiliation': 'Dermatology and Venereology, Faculty of medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Eman H', 'Initials': 'EH', 'LastName': 'El Maadawy', 'Affiliation': 'Dermatology and Venereology, Faculty of medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Gamal M', 'Initials': 'GM', 'LastName': 'El-Maghraby', 'Affiliation': 'Pharmaceutical Technology, Faculty of pharmacy, Tanta University, Tanta, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13272']
821,31535367,"Levcromakalim, an Adenosine Triphosphate-Sensitive Potassium Channel Opener, Dilates Extracerebral but not Cerebral Arteries.","BACKGROUND


ATP-sensitive potassium (K ATP  ) channel opener levcromakalim induces migraine attacks in migraine patients. Underlying mechanisms responsible for headache and migraine induction after levcromakalim infusion are unknown.
OBJECTIVE


To investigate the effect of levcromakalim on the cranial arteries and to explore the possible relationship between the middle meningeal artery (MMA) dilation and headache.
METHODS


In a double-blind, randomized, placebo-controlled study, 20 healthy volunteers were scanned at the baseline and repeatedly after infusion of levcromakalim (n = 14) and placebo (n = 6). All participants received a subcutaneous injection of sumatriptan 6 mg before the last scanning.
RESULTS


The MMA circumference was significantly larger after levcromakalim compared with placebo (P < .0001). The MMA dilation lasted over 5 hours during observational period. We found a significant association between headache and MMA dilation (P < .0001). The superficial temporal artery (STA) circumference was significantly larger after levcromakalim compared with placebo (P = .03) over the initial period (110 minutes). Over the entire observational period, there was no difference in circumference of the STA and the middle cerebral artery (MCA) between levcromakalim and placebo.
CONCLUSION


Levcromakalim dilated the MMA but not MCA. The MMA dilation was associated with headache. Future studies should investigate whether opening of K ATP  channels can activate and sensitize the perivascular nociceptors.",2019,The MMA circumference was significantly larger after levcromakalim compared with placebo (P < .0001).,"['migraine patients', '20 healthy volunteers']","['ATP-sensitive potassium (K ATP  ) channel opener levcromakalim', 'placebo', 'levcromakalim', 'subcutaneous injection of sumatriptan']","['MMA circumference', 'superficial temporal artery (STA) circumference', 'migraine attacks', 'headache and MMA dilation', 'circumference of the STA and the middle cerebral artery (MCA']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0244960', 'cui_str': 'Levcromakalim'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}]","[{'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}]",20.0,0.161541,The MMA circumference was significantly larger after levcromakalim compared with placebo (P < .0001).,"[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Glostrup Research Park, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob M', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene T', 'Initials': 'LT', 'LastName': 'Skovgaard', 'Affiliation': 'Department of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik B W', 'Initials': 'HBW', 'LastName': 'Larsson', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Headache,['10.1111/head.13634']
822,31535394,"Phase 3 Pilot Randomized Controlled Trial Comparing Early Trophic Enteral Nutrition With ""No Enteral Nutrition"" in Mechanically Ventilated Patients With Septic Shock.","BACKGROUND


The optimal dose and timing of enteral nutrition (EN) in septic shock are unclear.
METHODS


We conducted a phase 3 single-center randomized controlled pilot trial comparing early trophic EN with ""no EN"" in mechanically ventilated adults with septic shock, with the hypothesis that implementing a protocol comparing early trophic EN with ""no EN"" in patients with septic shock would be feasible. Patients were randomized to early trophic EN or ""no EN"" until off vasopressor for 3 hours. The primary outcome was feasibility in achieving >75% consent and compliance rate and <10% contamination rate.
RESULTS


One hundred thirty-one patients were eligible for enrollment, and 49 were available for consent. Thirty-one (86%) consented and were randomized and 100% of patients in the early EN arm and 94% in the ""no EN"" arm completed their protocols. While on vasopressors, early EN group received median 384 kcal, and the ""no EN"" group received median 0 kcal. Contamination rate was 0 in the early trophic EN arm and 6% in the ""no EN"" arm. The early EN group had median 25 intensive care unit-free days, as compared with 12 in the ""no EN"" arm (P = .014). The early EN arm had median 27 ventilator-free days, compared with 14 in ""no EN"" arm (P = .009).
CONCLUSION


Our protocol comparing early trophic EN with ""no EN"" in septic shock was feasible. Early trophic EN may be beneficial, but a larger multicenter trial is warranted to confirm the observed clinical benefits seen in this trial.",2020,"The early EN arm had median 27 ventilator-free days, compared with 14 in ""no EN"" arm (P = .009).
","['One hundred thirty-one patients were eligible for enrollment, and 49 were available for consent', 'Mechanically Ventilated Patients With Septic Shock', 'Thirty-one (86%) consented and were randomized and 100% of patients in the early EN arm and 94% in the ""no EN"" arm completed their protocols', 'mechanically ventilated adults with septic shock']","['No Enteral Nutrition', 'enteral nutrition (EN', 'early trophic EN or ""no EN"" until off vasopressor', 'trophic EN with ""no EN', 'Trophic Enteral Nutrition']","['feasibility in achieving >75% consent and compliance rate and <10% contamination rate', 'median 25 intensive care unit-free days', 'Contamination rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",131.0,0.135419,"The early EN arm had median 27 ventilator-free days, compared with 14 in ""no EN"" arm (P = .009).
","[{'ForeName': 'Jayshil J', 'Initials': 'JJ', 'LastName': 'Patel', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kozeniecki', 'Affiliation': 'Department of Nutrition Services, Froedtert Hospital, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Peppard', 'Affiliation': 'Department of Pharmacy, Froedtert & the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Peppard', 'Affiliation': 'Division of Trauma and Critical Care, Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Zellner-Jones', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Graf', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': 'Institute for Health & Policy, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Clinical Evaluation Research Unit, Department of Public Health Sciences, Queen's University, Department of Critical Care Medicine, Kingston General Hospital, Kingston, Ontario, Canada.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1706']
823,31650529,An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial.,"BACKGROUND


A femoral nerve block relieves pain after total hip arthroplasty, but its use is controversial due to motor paralysis accompanied by an increased risk of fall. Assumedly, the iliopsoas plane block (IPB) targets the hip articular branches of the femoral nerve without motor blockade. However, this has only been indicated in a cadaver study. Therefore, we designed this volunteer study.
METHODS


Twenty healthy volunteers were randomly allocated to blinded paired active vs. sham IPB (5 mL lidocaine 18 mg/mL with epinephrine vs saline). The primary outcome was reduction of maximal force of knee extension after IPB compared to baseline. Secondary outcomes included reduction of maximal force of hip adduction, and the pattern of injectate spread assessed with magnetic resonance imaging.
RESULTS


Mean (confidence interval) change of maximal force of knee extension from baseline to after IPB was -9.7 N (-22, 3.0) (P = .12) (n = 14). The injectate was consistently observed in an anatomically well-defined closed fascial compartment between the intra- and extra-pelvic components of the iliopsoas muscle anterior to the hip joint.
CONCLUSION


We observed no significant reduction of maximal force of knee extension after an IPB. The injectate was contained in a fascial compartment previously shown to contain all sensory branches from the femoral nerve to the hip joint. The clinical consequence of selective anesthesia of all sensory femoral nerve branches from the hip could be a reduced risk of fall compared to a traditional femoral nerve block. Registration of Trial: The trial was prospectively registered in EudraCT (Reference: 2018-000089-12, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2018-000089-12).",2020,We observed no significant reduction of maximal force of knee extension after an iliopsoas plane block.,['Twenty healthy volunteers'],['blinded paired active vs. sham iliopsoas plane block (5 mL lidocaine 18 mg/mL with epinephrine vs. saline'],"['Mean (confidence interval) change of maximal force of knee extension', 'reduction of maximal force of knee extension after iliopsoas plane block', 'maximal force of knee extension', 'reduction of maximal force of hip adduction, and the pattern of injectate spread assessed with magnetic resonance imaging']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]",20.0,0.358259,We observed no significant reduction of maximal force of knee extension after an iliopsoas plane block.,"[{'ForeName': 'Niels D', 'Initials': 'ND', 'LastName': 'Nielsen', 'Affiliation': 'Elective Surgery Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Merete N', 'Initials': 'MN', 'LastName': 'Madsen', 'Affiliation': 'Elective Surgery Center, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Helle K', 'Initials': 'HK', 'LastName': 'Østergaard', 'Affiliation': 'Department of Orthopedic Surgery, Viborg Regional Hospital, Viborg, Denmark.'}, {'ForeName': 'Siska', 'Initials': 'S', 'LastName': 'Bjørn', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Pedersen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Søballe', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Børglum', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Zealand University Hospital, University of Copenhagen, Roskilde, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13498']
824,31914790,Predictors for Poor Linkage to Care Among Hospitalized Persons Living with HIV and Co-Occurring Substance Use Disorder.,"Persons living with HIV (PLWH) with substance use disorders (SUD) remain a population difficult to engage in HIV care. Project HOPE (Hospital Visits as an Opportunity for Prevention and Engagement), a randomized controlled trial testing patient navigation with/without contingency management for PLWH with SUD, aimed to address this disparity. PLWH with SUD who were out of care were recruited from 11 hospitals across the United States from 2012 to 2014. Baseline socioeconomic factors, medical mistrust scores, and perceived discrimination surveys were collected at enrollment and evaluated for effects on linkage to care at the 6-month follow-up assessment. Linkage to care (attending an outpatient visit for HIV care), early linkage to care (attending first visit within 30 days of enrollment), and engagement in care (two HIV visits within the 6-month period) were determined by medical record abstraction, supplemented by self-report. Among 801 participants enrolled in the study (mean age 45 years, 33% women, and 73% African American), those who did not complete high school and with severe food insecurity had lower odds of being linked to care at 6 months. Those with high levels of medical mistrust, recent drug use, and who did not complete high school had lower odds of early linkage to care. Early linkage was associated with higher odds of engagement at 6 months and was mitigated by both patient navigator interventions (all  p  < .05). Addressing social determinants of health is critical to correct the disparity seen in HIV outcomes among PLWH with SUD. Identifying factors that alter the effect of interventions could help identify patients who would benefit most.",2020,Early linkage was associated with higher odds of engagement at 6 months and was mitigated by both patient navigator interventions (all p<0.05).,"['Persons living with HIV (PLWH) with substance use disorders (SUD', 'Hospitalized Persons Living with HIV and Co-Occurring Substance Use Disorder', 'PLWH with SUD who were out of care were recruited from 11 hospitals across the U.S. from 2012-2014', '801 participants enrolled in the study (mean age 45 years, 33% women, and 73% African American), those who did not complete high school and with severe food insecurity had lower odds of being linked to care at 6 months']",[],"['Baseline socioeconomic factors, medical mistrust scores, and perceived discrimination surveys']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0037464', 'cui_str': 'Socioeconomic Factors'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",801.0,0.0338922,Early linkage was associated with higher odds of engagement at 6 months and was mitigated by both patient navigator interventions (all p<0.05).,"[{'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Summers', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Colasanti', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Armstrong', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, UT Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': 'National Institute on Drug Abuse, Bethesda, Maryland, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Infectious Diseases Program, Grady Health System, Atlanta, Georgia, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",AIDS research and human retroviruses,['10.1089/AID.2019.0153']
825,31892758,The comparative efficacy of disinfectant wipes on common-use computer keyboards in a veterinary teaching hospital.,"The efficacies of 3 disinfectant wipes at reducing bacterial contamination on keyboards in a veterinary teaching hospital were studied. Thirty common-use keyboards were randomized into ""dirty"" and ""clean"" halves. Cultures were obtained from the ""dirty"" halves. The ""clean"" halves were disinfected with a randomly assigned wipe [peroxygen (AHP)-, alcohol-, quaternary ammonium (QAC)-based] or untreated (NT) and cultured. Colony-forming units (CFU) were enumerated after 48 hours. Mean reduction in CFU was 91.5%, 65.3%, 94.9%, and 78.8% for the AHP, alcohol, QAC, and NT groups, respectively. There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups. The reduction in CFUs in the NT group was attributed to the mechanical action of wiping the keyboard surface for culture. The use of disinfectant wipes reduced CFUs on keyboards and may be a useful component of veterinary infection control programs.",2020,There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups.,['Thirty common-use keyboards'],"['randomly assigned wipe [peroxygen (AHP)-, alcohol-, quaternary ammonium (QAC)-based] or untreated (NT) and cultured', 'disinfectant wipes']","['Mean reduction in CFU', 'CFUs', 'reduction in CFUs']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",30.0,0.016321,There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups.,"[{'ForeName': 'Eileen K', 'Initials': 'EK', 'LastName': 'Wong', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Brandy A', 'Initials': 'BA', 'LastName': 'Burgess', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Ben M', 'Initials': 'BM', 'LastName': 'Brainard', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Greene', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hurley', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Koenig', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}]",The Canadian veterinary journal = La revue veterinaire canadienne,[]
826,31975288,A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): results of a randomised-controlled feasibility study.,"BACKGROUND


Osteoarthritis is a prevalent condition in older adults that causes many patients to require a hip or knee replacement. Reducing patients' sedentariness prior to surgery may improve physical function and post-operative outcomes.
METHODS


We conducted a pragmatic randomised-controlled feasibility study with 2:1 allocation into intervention or usual care groups. The intervention, based on Self-Determination Theory, involved techniques to reduce sedentary behaviour, including motivational interviewing, setting of behavioural goals, and more. The primary outcome was feasibility, assessed using mixed methods. We included exploratory measures to inform a future definitive trial, such as ActivPal3 accelerometry to measure movement, the Short Physical Performance Battery (SPPB), Basic Psychological Needs, and cardiometabolic biomarkers. Assessments were at baseline, 1-week pre-surgery, and 6-week post-surgery.
RESULTS


We recruited 35 participants aged ≥ 60 years approximately 8 weeks before hip or knee arthroplasty. Participant uptake rate was 14.2%, and retention rate 85.7%. Participants were very satisfied with the study which was found to be feasible with some modifications. Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d -1 .
CONCLUSION


In this older surgical population, it is feasible to use behavioural techniques to displace sedentary time to activity and to conduct a trial spanning the period of surgical intervention. This may improve physical function and surgical outcomes. The INTEREST intervention is now ready for evaluation in a full-scale randomised-controlled trial.
REGISTRATION


This trial was registered on Clinicaltrials.gov on 13/11/2018. ID: NCT03740412.",2020,"Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d -1 .
CONCLUSION


","['60\xa0years approximately 8\xa0weeks before hip or knee arthroplasty', '35 participants aged\u2009≥', 'older adults', 'older adults undergoing orthopaedic surgery (INTEREST']",['ID'],"['SPPB', 'Short Physical Performance Battery (SPPB), Basic Psychological Needs, and cardiometabolic biomarkers', 'Participant uptake rate', 'sedentary time']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",35.0,0.12182,"Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d -1 .
CONCLUSION


","[{'ForeName': 'Justin Avery', 'Initials': 'JA', 'LastName': 'Aunger', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK. j.aunger@bham.ac.uk.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Davis', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Evans Atiah', 'Initials': 'EA', 'LastName': 'Asamane', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Carolyn Anne', 'Initials': 'CA', 'LastName': 'Greig', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01475-6']
827,31554528,Randomised trial of chronic supplementation with a nutraceutical mixture in subjects with non-alcoholic fatty liver disease.,"A mixture of natural ingredients, namely, DHA, phosphatidylcholine, silymarin, choline, curcumin and d-α-tocopherol, was studied in subjects with non-alcoholic fatty liver disease (NAFLD). Primary endpoints were serum levels of hepatic enzymes, and other parameters of liver function, the metabolic syndrome and inflammation were the secondary endpoints. The coagulation-fibrinolysis balance was also thoroughly investigated, as NAFLD is associated with haemostatic alterations, which might contribute to increased cardiovascular risk of this condition. The present study involved a double-blind, randomised, multicentre controlled trial of two parallel groups. Subjects with NAFLD (18-80 years, either sex) received the active or control treatment for 3 months. All assays were performed on a total of 113 subjects before and at the end of supplementation. The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased from 23·2 to 3·7 % after treatment, only the AST levels reaching statistical significance. However, no differences were found between control and active groups. Metabolic and inflammatory variables were unchanged, except for a slight (less than 10 %) increase in cholesterol and glucose levels after the active treatment. Coagulation-fibrinolytic parameters were unaffected by either treatment. In conclusion, chronic supplementation with the mixture of dietary compounds was well tolerated and apparently safe in NAFLD subjects. The trial failed to demonstrate any efficacy on relevant physiopathological markers, but its protocol and results may be useful to design future studies with natural compounds.",2020,"The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased after treatment from 23.2% to 3.7%, reaching statistical significance only for AST levels.","['Subjects with NAFLD (18-80 years, either sex', 'subjects with non alcoholic fatty liver disease (NAFLD', '113 total subjects', 'subjects with Non Alcoholic Fatty Liver Disease (NAFLD']","['docosahexaenoic acid (DHA), phosphatidylcholine, silymarin, choline, curcumin and D-α-tocopherol', 'nutraceutical mixture', 'chronic supplementation']","['Metabolic and inflammatory variables', 'coagulation-fibrinolysis balance', 'serum levels of hepatic enzymes; other parameters of liver function, metabolic syndrome and inflammation', 'cholesterol and glucose levels', 'Coagulation-fibrinolytic parameters', 'hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C1959616', 'cui_str': 'Phosphatidyl Cholines'}, {'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}]",,0.119658,"The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased after treatment from 23.2% to 3.7%, reaching statistical significance only for AST levels.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cerletti', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Colucci', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Storto', 'Affiliation': 'Clinical Pathology Unit, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Concetta T', 'Initials': 'CT', 'LastName': 'Ammollo', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Incampo', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Costanzo', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Bartolomeo', 'Affiliation': 'U.O. Internal Medicine, Ospedale ""F. Veneziale"", Isernia, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Portincasa', 'Affiliation': 'Clinica Medica ""A. Murri"", Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Section of Gastroenterology, Department of Emergency and Organ Transplantation, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Di Castelnuovo', 'Affiliation': 'Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Semeraro', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Iacoviello', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Gaetano', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}]",The British journal of nutrition,['10.1017/S0007114519002484']
828,31977929,Placebo effect in children: the role of expectation and learning.,"Classical conditioning and expectations are well-known underlying mechanisms of placebo hypoalgesia. Only little is known about their differential effect in adults, however, and even less in children. Previous studies in children evoked placebo hypoalgesia either with expectations alone or in combination with classical conditioning and revealed conflicting results. Furthermore, these studies investigated children of different ages making it even more difficult to draw conclusions. This study tried to disentangle classical conditioning and expectations by investigating them separately. To examine age effects, n = 172 children (6-9, 10-13, and 14-17 years) as well as n = 32 adults (> = 18 years) were tested using a heat pain paradigm investigating the effectiveness of creams some of which were bogusly introduced as analgesic. In addition to subjective pain intensity ratings, peripheral physiological measures were recorded. Results showed a successful induction of placebo hypoalgesia by both mechanisms for pain ratings and heart rate acceleration. Placebo hypoalgesia was particularly pronounced in children younger than 14 years. Furthermore, placebo hypoalgesia was more marked in children whose mothers raised the expectations. It was also stronger in participants who noticed a strong pain reduction during learning trials. These results encourage the use of placebo effect in clinical practice, particularly for younger children. They underline the relevance of an initial pain reduction and encourage the inclusion of parents in treatment.",2020,Placebo hypoalgesia was particularly pronounced in children under fourteen years.,"['children', '172 children (6-9, 10-13 and 14-17 years) as well as n = 32 adults (> 18 years', 'younger children', 'children under fourteen years']","['Placebo', 'placebo']","['pain ratings and heart rate acceleration', 'subjective pain intensity ratings peripheral physiological measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",172.0,0.0940302,Placebo hypoalgesia was particularly pronounced in children under fourteen years.,"[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gniß', 'Affiliation': 'Department of Clinical Psychology, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kappesser', 'Affiliation': ''}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Hermann', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001811']
829,31953079,"Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study.","BACKGROUND


Treatment options for patients with unresectable locally advanced pancreatic cancer are scarce. Results from a subanalysis of the phase 3 MPACT trial in metastatic pancreatic cancer suggested potential activity of nab-paclitaxel plus gemcitabine against locally advanced pancreatic cancer. The objective of this phase 2 trial was to evaluate safety and efficacy of nab-paclitaxel plus gemcitabine in previously untreated locally advanced pancreatic cancer.
METHODS


This international, open-label, multicentre, phase 2 trial (LAPACT) took place at 35 sites in five countries (USA, France, Spain, Canada, and Italy). Patients with Eastern Cooperative Oncology Group performance status of up to 1 underwent six cycles of induction with nab-paclitaxel 125 mg/m 2  plus gemcitabine 1000 mg/m 2  (days 1, 8, and 15 of each 28-day cycle). After induction, patients without progressive disease or unacceptable adverse events were eligible to receive continued therapy per investigator's choice: continued nab-paclitaxel plus gemcitabine, chemoradiation, or surgery. The primary endpoint was time to treatment failure; secondary endpoints were disease control rate, overall response rate, progression-free survival, overall survival, safety, and quality of life. The reported efficacy outcomes were analysed in the intention-to-treat population, and safety outcomes were analysed in the treated population. This trial is registered with ClinicalTrials.gov, NCT02301143, and EudraCT, 2014-001408-23 and is complete.
FINDINGS


Between April 21, 2015, and April 26, 2018, 107 patients were enrolled in the study. 106 received the study treatment; one patient enrolled but did not receive treatment. 44 (41%) of 107 enrolled patients discontinued induction; the most common reason for discontinuing induction was adverse events (22 [21%] patients). 62 (58%) of 107 enrolled patients completed induction treatment and 47 (44%) patients subsequently received continued treatment per investigator's choice: 12 (11%) continued nab-paclitaxel plus gemcitabine, 18 (17%) received chemoradiation, and 17 (16%) underwent surgery (seven had R0 resection status, nine had R1). 15 (14%) patients completed induction treatment but did not receive continued treatment. Median time to treatment failure was 9·0 months (90% CI 7·3-10·1); median progression-free survival was 10·9 months (90% CI 9·3-11·6), and median overall survival was 18·8 months (90% CI 15·0-24·0). During induction, 83 patients achieved disease control and the disease control rate was 77·6% (90% CI 70·3-83·5). 36 patients had a best response of partial response; the overall response rate during induction was 33·6% (90% CI 26·6-41·5). The most common treatment-emergent adverse events that were grade 3 or higher in the treated population during induction were neutropenia (35 [33%] of 106 patients), anaemia (12 [11%]), and fatigue (11 [10%]). The most common treatment-emergent serious adverse events during induction were pneumonia (five [5%] patients), pyrexia (five [5%]), and febrile neutropenia (three [3%]). No deaths were caused by treatment-related adverse events during the induction phase, and global quality of life was maintained in most patients.
INTERPRETATION


The data from this trial support the tolerability and activity of nab-paclitaxel plus gemcitabine for locally advanced pancreatic cancer, and a potential to convert unresectable, locally advanced disease to surgically resectable disease. The safety profile was generally consistent with previous findings.
FUNDING


Celgene.",2020,"No deaths were caused by treatment-related adverse events during the induction phase, and global quality of life was maintained in most patients.
","['Patients with Eastern Cooperative Oncology Group performance status of up to 1 underwent six cycles of', 'patients without progressive disease or unacceptable adverse events', 'against locally advanced pancreatic cancer', 'previously untreated locally advanced pancreatic cancer', '62 (58%) of 107 enrolled patients completed induction treatment and 47 (44', 'patients with locally advanced pancreatic cancer (LAPACT', 'patients with unresectable locally advanced pancreatic cancer', 'Between April 21, 2015, and April 26, 2018, 107 patients were enrolled in the study']","['induction with nab-paclitaxel 125 mg/m 2  plus gemcitabine', 'nab-paclitaxel plus gemcitabine, chemoradiation, or surgery', 'nab-paclitaxel plus gemcitabine', 'Nab-paclitaxel plus gemcitabine', 'paclitaxel plus gemcitabine']","['safety and efficacy', 'intention-to-treat population, and safety outcomes', 'adverse events', 'median overall survival', 'neutropenia', 'anaemia', 'pyrexia', 'Median time to treatment failure', 'median progression-free survival', 'febrile neutropenia', 'overall response rate', 'disease control and the disease control rate', 'time to treatment failure; secondary endpoints were disease control rate, overall response rate, progression-free survival, overall survival, safety, and quality of life', 'global quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",107.0,0.166793,"No deaths were caused by treatment-related adverse events during the induction phase, and global quality of life was maintained in most patients.
","[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute, Wayne State University, Hudson-Webber Cancer Research Center, Detroit, MI, USA. Electronic address: philipp@karmanos.org.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Lacy', 'Affiliation': 'Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Department of Digestive Oncology, Institut du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology, IRCCS Ospedale San Martino IST, Genoa, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pazo-Cid', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Manzano Mozo', 'Affiliation': ""Department of Medical Oncology, Hospital Germans Trias i Pujol, Institut Català d'Oncologia Badalona, Barcelona, Spain.""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, UC Davis School of Medicine, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Dowden', 'Affiliation': 'Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zakari', 'Affiliation': 'Department of Internal Medicine, AdventHealth Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Terrebonne', 'Affiliation': 'Department of Gastroenterology, CHU Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Bathini', 'Affiliation': 'Division of Hematology/Oncology, UMass Memorial Medical Center, Worcester, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-Trabada', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Asselah', 'Affiliation': 'Department of Oncology, McGill University Royal Victoria Hospital, Montréal, QC, Canada.'}, {'ForeName': 'Muhammad Wasif', 'Initials': 'MW', 'LastName': 'Saif', 'Affiliation': 'Medical Oncology, Northwell Health Cancer Institute, Lake Success, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Shiansong Li', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Teng Jin', 'Initials': 'TJ', 'LastName': 'Ong', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nydam', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Department of Pancreatology, Hôpital Beaujon (AP-HP), Université Denis Diderot-Paris VII, Clichy, France.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30327-9']
830,31482319,"Recovery from Copperhead Snake Envenomation: Role of Age, Sex, Bite Location, Severity, and Treatment.","INTRODUCTION


Few data exist to understand the recovery phase of pit viper envenomation. A recently published placebo-controlled clinical trial affords this opportunity. The purpose of this study is to examine the time course of recovery from copperhead snake (Agkistrodon contortrix) envenomation patients managed with and without the use of antivenom, stratified by age, sex, anatomic site of envenomation, initial severity of envenomation, and geographic region.
METHODS


This is a post-hoc subgroup analysis of data from a multi-center double-blinded clinical trial of Fab antivenom (FabAV) vs. placebo. Outcomes were the Patient-Specific Functional Scale (PSFS) score at 3, 7, 10, and 14 days after envenomation. Least-squares mean PSFS score curves were calculated for each subgroup, and repeated measures ANOVA was used to estimate between-group comparisons.
RESULTS


Seventy-two subjects were included, of whom 44 received FabAV. Males demonstrated better overall recovery than females (model predicted PSFS score 6.18 vs 4.99; difference 1.19; 95% CI 0.12 to 2.25; p = 0.029). No sex difference was found in response to FabAV. Overall recovery and effect of FabAV were similar in adult vs adolescent patients, patients with upper vs lower extremity envenomation, and patients with initially mild vs moderate envenomation signs. Analysis by geographic location was not successful due to ANOVA mode instability.
CONCLUSIONS


Male victims of copperhead snake envenomation demonstrate slightly better recovery than females, but response to Fab antivenom overall is similar across all subgroups studied.",2020,"Overall recovery and effect of FabAV were similar in adult vs adolescent patients, patients with upper vs lower extremity envenomation, and patients with initially mild vs moderate envenomation signs.","['patients managed with and without the use of antivenom, stratified by age, sex, anatomic site of envenomation, initial severity of envenomation, and geographic region', 'Seventy-two subjects were included, of whom 44 received FabAV']","['placebo', 'Fab antivenom (FabAV) vs. placebo', 'copperhead snake (Agkistrodon contortrix) envenomation']","['overall recovery', 'Patient-Specific Functional Scale (PSFS) score', 'Least-squares mean PSFS score curves', 'Overall recovery and effect of FabAV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0003450', 'cui_str': 'Antivenoms'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003450', 'cui_str': 'Antivenoms'}, {'cui': 'C0206310', 'cui_str': 'Copperhead'}, {'cui': 'C0037382', 'cui_str': 'Ophidia'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4304945', 'cui_str': 'Patient-Specific Functional Scale score'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",72.0,0.392421,"Overall recovery and effect of FabAV were similar in adult vs adolescent patients, patients with upper vs lower extremity envenomation, and patients with initially mild vs moderate envenomation signs.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lavonas', 'Affiliation': 'Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, USA. eric.lavonas@dhha.org.'}, {'ForeName': 'Randy I', 'Initials': 'RI', 'LastName': 'Burnham', 'Affiliation': 'Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schwarz', 'Affiliation': 'Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Quackenbush', 'Affiliation': 'Department of Emergency Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Texas A&M Health Science Center, College Station, TX, USA.'}, {'ForeName': 'S Rutherfoord', 'Initials': 'SR', 'LastName': 'Rose', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Greene', 'Affiliation': 'Henry J. N. Taub Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Toschlog', 'Affiliation': 'Department of Surgery, Brody School of Medicine at East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Nathan P', 'Initials': 'NP', 'LastName': 'Charlton', 'Affiliation': 'Division of Medical Toxicology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Mullins', 'Affiliation': 'Division of Emergency Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Department of Emergency Medicine and Hospital Services, Medical College of Georgia, Augusta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Denning', 'Affiliation': 'Department of Surgery, Marshall Health, Huntington, WV, USA.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kleinschmidt', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Bush', 'Affiliation': 'Department of Emergency Medicine, Brody School of Medicine at East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Anderson', 'Affiliation': 'Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, USA.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Gerardo', 'Affiliation': 'Division of Emergency Medicine, Department of Surgery, Duke University School of Medicine, Durham, NC, USA.'}]",Journal of medical toxicology : official journal of the American College of Medical Toxicology,['10.1007/s13181-019-00733-y']
831,31624854,Short-term dialysis catheter versus central venous catheter infections in ICU patients: a post hoc analysis of individual data of 4 multi-centric randomized trials.,"PURPOSE


Little is known on catheter-related infections associated with short-term dialysis catheters (DC). Recommendations for infection prevention are mostly derived from those related to central venous catheters (CVC). A comparison of infectious risk of DCs and CVCs would be instrumental for improving infection control prevention strategies. This study aimed to describe differences in infectious risk between DC and CVC.
METHODS


We used individual data from 4 multicenter randomized controlled trials in intensive care units (ICUs) that evaluated various prevention strategies regarding colonization, major catheter-related infections (MCRI) and catheter-related bloodstream infections (CR-BSI). We selected only catheters with non-chlorhexidine gluconate impregnated dressings. A marginal Cox model for clustered data was used for the evaluation of the daily hazard rate for catheter-tip colonization, MCRI and CR-BSI.
RESULTS


We included 3029 patients and 4148 catheters (31,547 catheter-days) which comprised 1872 DCs and 2276 CVCs. After adjustment on confounders, we identified an increased risk in DC compared to CVC for colonization (HR 1.45, 95% CI 1.03-2.04, p = 0.04) and for MCRI (HR 2.97, 95% CI 1.03-8.51, p = 0.04) in the first 7 days of catheter maintenance. The daily hazard rate for colonization and MCRI was generally higher for DC in the first catheter-days, whereas it was similar between DC and CVC for longer catheterizations.
CONCLUSIONS


The daily risk of colonization and MCRI was significantly higher in DC compared to CVC within the first 7 days of catheter maintenance. Targeted prevention strategies for DC should mostly focus on the period following the insertion.",2019,"After adjustment on confounders, we identified an increased risk in DC compared to CVC for colonization (HR 1.45, 95% CI 1.03-2.04, p = 0.04) and for MCRI (HR 2.97, 95% CI 1.03-8.51, p = 0.04) in the first 7 days of catheter maintenance.","['3029 patients and 4148 catheters (31,547 catheter-days) which comprised 1872 DCs and 2276 CVCs', 'ICU patients']","['Short-term dialysis catheter versus central venous catheter infections', 'chlorhexidine gluconate impregnated dressings']","['daily risk of colonization and MCRI', 'daily hazard rate for colonization and MCRI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0179747', 'cui_str': 'Dialysis catheter'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C1272974', 'cui_str': 'Impregnated dressing'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",3029.0,0.0850983,"After adjustment on confounders, we identified an increased risk in DC compared to CVC for colonization (HR 1.45, 95% CI 1.03-2.04, p = 0.04) and for MCRI (HR 2.97, 95% CI 1.03-8.51, p = 0.04) in the first 7 days of catheter maintenance.","[{'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Buetti', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Ruckly', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Lucet', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mimoz', 'Affiliation': 'Services des Urgences Adultes and SAMU 86, Centre Hospitalier Universitaire de Poitiers, 86021, Poitiers, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'Medical ICU, Gabriel-Montpied University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France. jean-francois.timsit@aphp.fr.'}]",Intensive care medicine,['10.1007/s00134-019-05812-w']
832,31930338,Serious Adverse Events Cluster in Participants Experiencing the Primary Composite Cardiovascular Endpoint: A Post Hoc Analysis of the SPRINT Trial.,"BACKGROUND


Intensively treated participants in the SPRINT study experienced fewer primary cardiovascular composite study endpoints (CVD events) and lower mortality, although 38% of participants experienced a serious adverse event (SAE). The relationship of SAEs with CVD events is unknown.
METHODS


CVD events were defined as either myocardial infarction, acute coronary syndrome, decompensated heart failure, stroke, or death from cardiovascular causes. Cox models were utilized to understand the occurrence of SAEs with CVD events according to baseline atherosclerotic cardiovascular disease (ASCVD) risk.
RESULTS


SAEs occurred in 96% of those experiencing a CVD event but only in 34% (P < 0.001) of those not experiencing a CVD event. Occurrence of SAEs monotonically increased across the range of baseline ASCVD risk being approximately twice as great in the highest compared with the lowest risk category. SAE occurrence was strongly associated with ASCVD risk but was similar within risk groups across treatment arms. In adjusted Cox models, experiencing a CVD event was the strongest predictor of SAEs in all risk groups. By the end of year 1, the hazard ratios for the low, middle, and high ASCVD risk tertiles, and baseline clinical CVD group were 2.56 (95% CI = 1.39-4.71); 2.52 (1.63-3.89); 3.61 (2.79-4.68); 1.86 (1.37-2.54), respectively-a trend observed in subsequent years until study end. Intensive treatment independently predicted SAEs only in the second ASVCD risk tertile.
CONCLUSIONS


The occurrence of SAEs is multifactorial and mostly related to prerandomization patient characteristics, most prominently ASCVD risk, which, in turn, relates to in-study CVD events.",2020,"RESULTS


SAEs occurred in 96% of those experiencing a CVD event but only in 34% (p < 0.001) of those not experiencing a CVD event.",['Participants Experiencing the Primary Composite Cardiovascular Endpoint'],[],"['myocardial infarction, acute coronary syndrome, decompensated heart failure, stroke, or death from cardiovascular causes', 'SAEs', 'hazard ratios', 'ASCVD risk', 'SAE occurrence', 'serious adverse event (SAE']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",[],"[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0777405,"RESULTS


SAEs occurred in 96% of those experiencing a CVD event but only in 34% (p < 0.001) of those not experiencing a CVD event.","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Botchway', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Buhnerkempe', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Prakash', 'Affiliation': 'Center for Clinical Research, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Al-Akchar', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Bemi', 'Initials': 'B', 'LastName': 'Adekola', 'Affiliation': 'Division of General Internal Medicine, Hypertension Section, Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Flack', 'Affiliation': 'Division of General Internal Medicine, Hypertension Section, Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa010']
833,32406728,A cluster randomized controlled trial of a positive physical activity intervention.,"OBJECTIVE


Due to global urbanization, technological advancements, and increasing convenience in daily activities, reduced energy expenditure in all aspects of life has become a major public health concern. A positive physical activity (PPA) intervention was developed to promote physical activity and fitness among Hong Kong families. PPA utilizes positive affective attitudes to circumvent barriers to health behavior change by helping families associate feelings of enjoyment with physical activity. Zero-Time Exercise (ZTEx) was introduced and promoted as a foot-in-the-door approach.
METHOD


Using a community-based collaborative approach, the research team worked with social service organizations, a government department, and schools to implement a cluster randomized controlled crossover trial at a citywide scale. A total of 1,983 eligible participants from 1,467 families were recruited from all 18 districts in Hong Kong. Data were collected using structured questionnaires and physical fitness assessments at preintervention and 1-month and 3-month follow-up.
RESULTS


PPA was effective in increasing ZTEx and ZTEx with family members at 1-month and 3-month follow-up and in improving balance and endurance at 3-month follow-up. Semistructured focus groups provided further support for the intervention effectiveness and added in-depth insights into the participants' motivational, interpersonal, and affective experiences.
CONCLUSION


The results not only shed light on the intervention's effectiveness for physical activity and fitness but also demonstrated that the community-based collaborative approach was successful in engaging relevant stakeholders in an active and fruitful partnership with effective capacity building for program development. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


PPA was effective in increasing ZTEx and ZTEx with family members at 1-month and 3-month follow-up and in improving balance and endurance at 3-month follow-up.","['Using a community-based collaborative approach', '1,983 eligible participants from 1,467 families were recruited from all 18 districts in Hong Kong']","['Zero-Time Exercise (ZTEx', 'positive physical activity (PPA) intervention', 'positive physical activity intervention', 'PPA']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],1467.0,0.0423359,"RESULTS


PPA was effective in increasing ZTEx and ZTEx with family members at 1-month and 3-month follow-up and in improving balance and endurance at 3-month follow-up.","[{'ForeName': 'Henry C Y', 'Initials': 'HCY', 'LastName': 'Ho', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Moses Wai-Keung', 'Initials': 'MW', 'LastName': 'Mui', 'Affiliation': 'Hong Kong Council of Social Service.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Wan', 'Affiliation': 'School of Public Health.'}, {'ForeName': 'Carol Wing-See', 'Initials': 'CW', 'LastName': 'Yew', 'Affiliation': 'United Centre of Emotional Health and Positive Living.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000885']
834,31696936,Global REACH 2018: The influence of acute and chronic hypoxia on cerebral haemodynamics and related functional outcomes during cold and heat stress.,"KEY POINTS


Thermal and hypoxic stress commonly coexist in environmental, occupational and clinical settings, yet how the brain tolerates these multi-stressor environments is unknown Core cooling by 1.0°C reduced cerebral blood flow (CBF) by 20-30% and cerebral oxygen delivery (CDO 2  ) by 12-19% at sea level and high altitude, whereas core heating by 1.5°C did not reliably reduce CBF or CDO 2  Oxygen content in arterial blood was fully restored with acclimatisation to 4330 m, but concurrent cold stress reduced CBF and CDO 2  Gross indices of cognition were not impaired by any combination of thermal and hypoxic stress despite large reductions in CDO 2  Chronic hypoxia renders the brain susceptible to large reductions in oxygen delivery with concurrent cold stress, which might make monitoring core temperature more important in this context ABSTRACT: Real-world settings are composed of multiple environmental stressors, yet the majority of research in environmental physiology investigates these stressors in isolation. The brain is central in both behavioural and physiological responses to threatening stimuli and, given its tight metabolic and haemodynamic requirements, is particularly susceptible to environmental stress. We measured cerebral blood flow (CBF, duplex ultrasound), cerebral oxygen delivery (CDO 2  ), oesophageal temperature, and arterial blood gases during exposure to three commonly experienced environmental stressors - heat, cold and hypoxia - in isolation, and in combination. Twelve healthy male subjects (27 ± 11 years) underwent core cooling by 1.0°C and core heating by 1.5°C in randomised order at sea level; acute hypoxia (  P   ET   ,   O   2         = 50 mm Hg) was imposed at baseline and at each thermal extreme. Core cooling and heating protocols were repeated after 16 ± 4 days residing at 4330 m to investigate any interactions with high altitude acclimatisation. Cold stress decreased CBF by 20-30% and CDO 2  by 12-19% (both P < 0.01) irrespective of altitude, whereas heating did not reliably change either CBF or CDO 2  (both P > 0.08). The increases in CBF with acute hypoxia during thermal stress were appropriate to maintain CDO 2  at normothermic, normoxic values. Reaction time was faster and slower by 6-9% with heating and cooling, respectively (both P < 0.01), but central (brain) processes were not impaired by any combination of environmental stressors. These findings highlight the powerful influence of core cooling in reducing CDO 2  . Despite these large reductions in CDO 2  with cold stress, gross indices of cognition remained stable.",2020,"•Gross indices of cognition were not impaired by any combination of thermal and hypoxic stress despite large reductions in CDO 2  •Chronic hypoxia renders the brain susceptible to large reductions in oxygen delivery with concurrent cold stress, which might make monitoring core temperature more important in this context ABSTRACT: Real-world settings are composed of multiple environmental stressors, yet the majority of research in environmental physiology investigates these stressors in isolation.",['Twelve healthy male subjects (27\xa0±\xa011 years) underwent'],['core cooling by 1.0\xa0°C and core heating by 1.5\xa0°C'],"['CBF with acute hypoxia', 'Reaction time', 'cerebral blood flow (CBF, duplex ultrasound), cerebral oxygen delivery (CDO 2  ), oesophageal temperature, and arterial blood gases during exposure to three commonly experienced environmental stressors - heat, cold and hypoxia - in isolation, and in combination', 'CBF', 'cerebral blood flow (CBF']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0242845', 'cui_str': 'Ultrasonography, Doppler, Duplex'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0220862', 'cui_str': 'isolation'}]",12.0,0.0334794,"•Gross indices of cognition were not impaired by any combination of thermal and hypoxic stress despite large reductions in CDO 2  •Chronic hypoxia renders the brain susceptible to large reductions in oxygen delivery with concurrent cold stress, which might make monitoring core temperature more important in this context ABSTRACT: Real-world settings are composed of multiple environmental stressors, yet the majority of research in environmental physiology investigates these stressors in isolation.","[{'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Gibbons', 'Affiliation': 'School of Physical Education, Sport & Exercise Science, University of Otago, 55/47 Union St W, Dunedin, 9016, New Zealand.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Thomas', 'Affiliation': 'Department of Surgical Sciences, University of Otago, 201 Great King St, Dunedin, 9016, New Zealand.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Otago, 201 Great King St, Dunedin, 9016, New Zealand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stembridge', 'Affiliation': 'Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cyncoed Road, Cardiff, CF23 6XD, UK.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Caldwell', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Howe', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Hoiland', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Akerman', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, 125 University St, Ottawa, Ontario, Canada, K1N 6N5.'}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Dawkins', 'Affiliation': 'Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cyncoed Road, Cardiff, CF23 6XD, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Patrician', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Coombs', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gasho', 'Affiliation': 'Division of Pulmonary, Critical Care, Hyperbaric and Sleep Medicine, Loma Linda University School of Medicine, Loma Linda, CA, USA.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Stacey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, UK.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Cotter', 'Affiliation': 'School of Physical Education, Sport & Exercise Science, University of Otago, 55/47 Union St W, Dunedin, 9016, New Zealand.'}]",The Journal of physiology,['10.1113/JP278917']
835,31711752,"Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial.","BACKGROUND


Therapies with novel mechanisms of action against hepatitis B virus (HBV) infection are being explored with the goal of achieving a functional cure (sustained off-treatment response) without requiring lifelong therapy. We aimed to evaluate the pharmacokinetics, safety, and antiviral activity of ABI-H0731, an investigational inhibitor of the HBV core protein.
METHODS


This phase 1, randomised, placebo-controlled study was done in two parts. In part 1, healthy adults without hepatitis B aged 18-65 years at one clinical research centre in New Zealand (eight participants per dose cohort) were randomly assigned (3:1) to receive single oral doses of ABI-H0731 (100, 300, 600, or 1000 mg) or matching placebo, or once-daily or twice-daily doses of ABI-H0731 800 mg or matching placebo for 7 days. In part 2, adults aged 18-65 years at clinical research centres in New Zealand, Australia, the UK, Hong Kong, Taiwan, and South Korea with chronic HBV (12 participants per dose cohort) were randomly assigned (5:1) to receive ABI-H0731 (100, 200, 300, or 400 mg) or matching placebo once daily for 28 days. In part 2, participants were required to have HBeAg-positive or HBeAg-negative chronic HBV infection, with serum HBV DNA concentrations of at least 2 × 10 4  IU/mL (HBeAg-positive) or 2 × 10 3  IU/mL (HBeAg-negative) and serum alanine aminotransferase concentrations less than seven times the upper limit of normal. Both parts used simple randomisation, with study participants, site personnel, and study monitors masked to treatment assignments. The primary study objective was dose-related safety and tolerability of ABI-H0731 in healthy volunteers and in participants with chronic HBV infection, assessed in all treated participants. Key secondary assessments included pharmacokinetic analyses and virological responses. This study is registered with ClinicalTrials.gov, identifier NCT02908191 and is completed.
FINDINGS


48 [61%] of 79 healthy volunteers were enrolled in the single-ascending or multiple-ascending dose phase of part 1 between Nov 16, 2016, and Jan, 27, 2017. 38 [55%] of 69 HBV-infected participants were enrolled in part 2 between June 15, 2017, and March 15, 2018. All adverse events were non-specific and of mild or moderate intensity apart from a single HBV-infected participant given the 400 mg dose who developed a severe (grade 3) maculopapular rash and terminated treatment. Overall, the most frequent adverse events of any grade among the 74 participants who received ABI-H0731 were headache (11 [15%]), influenza-like illness (seven [9%]), and dizziness (six [8%]); the most frequent adverse events considered treatment-related were rash (four [5%]) and dizziness (three [4%]). In part 1, ABI-H0731 reached maximum plasma concentrations (T max ) in 2·50-4·17 h; the mean plasma half-life (t 1/2 ) was 23·5-28·4 h. In part 2, mean maximum HBV DNA declines from baseline were 1·7 log 10  IU/mL in the 100 mg dose cohort, 2·1 log 10  IU/mL in the 200 mg dose cohort, and 2·8 log 10  IU/mL in the 300 mg dose cohort. Across dose cohorts, serum HBV RNA declines correlated with HBV DNA declines.
INTERPRETATION


No pattern of treatment-emergent adverse events was observed at ABI-H0731 doses up to 300 mg in individuals with chronic hepatitis B. ABI-H0731 was rapidly absorbed and exhibited a plasma half-life supportive of once-daily dosing. Dose-dependent decreases in serum HBV DNA and RNA concentrations are consistent with the proposed mechanism of action.
FUNDING


Assembly Biosciences.",2020,No pattern of treatment-emergent adverse events was observed at ABI-H0731 doses up to 300 mg in individuals with chronic hepatitis B. ABI-H0731 was rapidly absorbed and exhibited a plasma half-life supportive of once-daily dosing.,"['healthy volunteers and in participants with chronic HBV infection, assessed in all treated participants', 'healthy adults without hepatitis B aged 18-65 years at one clinical research centre in New Zealand (eight participants per dose cohort', '79 healthy volunteers were enrolled in the single-ascending or multiple-ascending dose phase of part 1 between Nov 16, 2016, and Jan, 27, 2017', '48', 'adults aged 18-65 years at clinical research centres in New Zealand, Australia, the UK, Hong Kong, Taiwan, and South Korea with chronic HBV (12 participants per dose cohort', '38 [55%] of 69 HBV-infected participants were enrolled in part 2 between June 15, 2017, and March 15, 2018']","['placebo', 'matching placebo', 'matching placebo, or once-daily or twice-daily doses of ABI-H0731 800 mg or matching placebo']","['Safety, pharmacokinetics, and antiviral effects', 'maximum plasma concentrations (T max ', 'influenza-like illness', 'headache', 'pharmacokinetics, safety, and antiviral activity', 'pharmacokinetic analyses and virological responses', 'mean maximum HBV DNA declines', 'serum HBV DNA and RNA concentrations', 'HBeAg-positive or HBeAg-negative chronic HBV infection, with serum HBV DNA concentrations', 'dizziness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",79.0,0.415045,No pattern of treatment-emergent adverse events was observed at ABI-H0731 doses up to 300 mg in individuals with chronic hepatitis B. ABI-H0731 was rapidly absorbed and exhibited a plasma half-life supportive of once-daily dosing.,"[{'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region, China. Electronic address: mfyuen@hkucc.hku.hk.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': ""Institute of Liver Studies, King's College Hospital, London, UK.""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwabe', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Hallym University, Chuncheon Sacred Heart Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Young-Suk', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Linear Clinical Research, Perth, WA, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sievert', 'Affiliation': 'Monash Health, Monash University, VIC, Australia.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Visvanathan', 'Affiliation': ""St Vincent's Hospital, Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ruby', 'Affiliation': 'Assembly Biosciences, San Francisco, CA, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Liaw', 'Affiliation': 'Assembly Biosciences, San Francisco, CA, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'Assembly Biosciences, San Francisco, CA, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Assembly Biosciences, San Francisco, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Colonno', 'Affiliation': 'Assembly Biosciences, San Francisco, CA, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Lopatin', 'Affiliation': 'Assembly Biosciences, San Francisco, CA, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30346-2']
836,31603582,Auricular acupuncture for adult tonsillectomy.,"OBJECTIVES


Adult tonsillectomy causes significant postoperative pain that can last over 14 days, but narcotic regimens only provide a modest reduction in pain. Auricular acupuncture has been demonstrated to improve pain with minimal complications. This study compared acupuncture versus control for pain, opioid consumption, nausea, and return of diet and activity following tonsillectomy.
METHODS


A prospective, single-blinded randomized controlled trial was performed on 134 adults undergoing tonsillectomy at a tertiary care teaching hospital. Each patient was randomized to receive either auricular (Battlefield protocol) acupuncture with auricular bandages or bandages alone while under general anesthesia. Subjects journaled daily postoperative pain, diet, activity, and opioid consumption, then returned to the clinic on postoperative day 14 for a final questionnaire and evaluation.
RESULTS


Ninety-nine patients completed the study with 50 patients in the acupuncture group and 49 patients in the control group. Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter. There was an equivalent level of postoperative narcotic usage, nausea, emesis, functional activity and diet between the two groups. The main complication following tonsillectomy was secondary hemorrhage and there was no significant difference between the two groups (20%, 10%; P = .13).
CONCLUSION


Auricular acupuncture provides increased pain relief on the day of surgery, an effect that seems to diminish after 24 hours.
LEVEL OF EVIDENCE


1b Laryngoscope, 130: 1907-1912, 2020.",2020,"Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter.","['134 adults undergoing tonsillectomy at a tertiary care teaching hospital', 'Ninety-nine patients completed the study with 50 patients in the acupuncture group and 49 patients in the control group', 'adult tonsillectomy']","['auricular (Battlefield protocol) acupuncture with auricular bandages or bandages alone while under general anesthesia', 'Auricular acupuncture', 'acupuncture']","['Subjects journaled daily postoperative pain, diet, activity, and opioid consumption', 'pain', 'pain with minimal complications', 'pain thereafter', 'postoperative narcotic usage, nausea, emesis, functional activity and diet', 'Pain scores', 'pain relief', 'pain, opioid consumption, nausea, and return of diet and activity']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}]","[{'cui': 'C2316067', 'cui_str': 'Journaling (regime/therapy)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",99.0,0.193897,"Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter.","[{'ForeName': 'Anil N', 'Initials': 'AN', 'LastName': 'Shah', 'Affiliation': 'Department of Otolaryngology, Naval Hospital Bremerton, Bremerton, Washington, U.S.A.'}, {'ForeName': 'Chad B', 'Initials': 'CB', 'LastName': 'Moore', 'Affiliation': 'Nurse Anesthesia Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, U.S.A.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Brigger', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28338']
837,31410968,Clinical relevance of ticagrelor monotherapy following 1-month dual antiplatelet therapy after bifurcation percutaneous coronary intervention: Insight from GLOBAL LEADERS trial.,"BACKGROUND


The aim of this study was to investigate the impact of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for bifurcation lesions.
METHODS


GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing 1-month DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. The primary endpoint was a composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years.
RESULTS


Among the 15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion. The incidence of the primary endpoint was similar between the bifurcation and nonbifurcation groups (4.7 vs. 4.0%, p = .083). The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment.
CONCLUSIONS


After PCI for bifurcation lesions using 1-month of DAPT followed by ticagrelor monotherapy for 23 months did not demonstrate explicit benefit regarding all-cause death or new Q-wave MI as in the overall trial.",2020,"The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment.
","['patients treated with a biolimus A9-eluting stent', '15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion', 'bifurcation percutaneous coronary intervention']","['ticagrelor monotherapy', 'DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy']","['composite of all-cause death or new Q-wave myocardial infarction (MI) at 2\u2009years', 'definite or probable stent thrombosis', 'stroke', 'presence/absence of a bifurcation lesion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",2498.0,0.142694,"The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment.
","[{'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'De Wilder', 'Affiliation': 'Heart Centre, Imelda Hospital Bonheiden, Bonheiden, Belgium.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Komiyama', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, Villa Maria Cecila Hospital GVM, Cotignola (RA), Italy.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Louvard', 'Affiliation': 'Department of Cardiology, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'G Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials (FACT), Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart and Thorax Center, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Faculty of Medicine and Life Sciences, Jessa Ziekenhuis, the Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Clinical Research, Morges, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Heart Centre, Imelda Hospital Bonheiden, Bonheiden, Belgium.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, Imperial College London, London, UK.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28428']
838,31913519,"Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial.","OBJECTIVE


To evaluate the long-term safety and tolerability of ubrogepant for the acute treatment of migraine.
BACKGROUND


Ubrogepant is an oral, calcitonin gene-related receptor antagonist in development for the acute treatment of migraine. The efficacy of ubrogepant was demonstrated in 2 phase 3 trials in which a significant improvement was observed in migraine headache pain, migraine-associated symptoms, and ability to function.
METHODS


This was a phase 3, multicenter, randomized, open-label, 52-week extension trial. Adults with migraine with or without aura entered the trial after completing one of 2 phase 3 lead-in trials and were re-randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg. Randomization to ubrogepant dose was blinded. Those randomized to usual care continued to treat migraine attacks with their own medication. The usual care arm was included in this trial to capture background rates of hepatic laboratory parameters and contextualize hepatic safety assessments. Safety and tolerability were the primary outcome measures. The safety population for the ubrogepant arms included all randomized participants who received at least 1 dose of treatment. All cases of alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevations of ≥3 times the upper limit of normal were adjudicated by an independent panel of liver experts who were blinded to dose.
RESULTS


The safety population included 1230 participants (404 in the ubrogepant 50-mg group, 409 in the ubrogepant 100-mg group, and 417 in the usual care group). Participants were on average 42 years of age, 90% (1106/1230) female and 85% (1043/1230) white, with an average BMI of 30 kg/m 2  . Throughout the trial, 21,454 migraine attacks were treated with 31,968 doses of ubrogepant. Treatment-emergent adverse events (TEAEs) were reported by 268/404 (66%) participants receiving ubrogepant 50 mg and 297/409 (73%) receiving ubrogepant 100 mg. The most commonly reported TEAE was upper respiratory tract infection (<12%); findings were similar across dose groups. Treatment-related TEAEs were reported by 42/404 (10%) participants in the ubrogepant 50-mg group and 43/409 (11%) in the ubrogepant 100-mg group. Serious adverse events (SAEs) were reported by 9/404 (2%) participants in the ubrogepant 50-mg group and 12/409 (3%) participants in the ubrogepant 100-mg group. Twenty cases of ALT/AST levels of ≥3 times the upper limit of normal were reported and reviewed by an independent clinical adjudication committee of liver experts. There were no cases of Hy's Law.
CONCLUSIONS


Long-term intermittent use of ubrogepant 50 and 100 mg given as 1 or 2 doses per attack for the acute treatment of migraine was safe and well tolerated, as indicated by a low incidence of treatment-related TEAEs and SAEs and discontinuations due to adverse events in this 1-year trial.",2020,The most commonly reported TEAE was upper respiratory tract infection (<12%); findings were similar across dose groups.,"['Adults with migraine with or without aura entered the trial after completing one of 2 phase 3 lead-in trials', '1230 participants (404 in the ubrogepant 50-mg group, 409 in the ubrogepant 100-mg group, and 417 in the usual care group', 'Participants were on average 42\xa0years of age, 90% (1106/1230) female\xa0and 85% (1043/1230) white, with an average BMI of 30\xa0kg/m 2  ', 'Migraine']","['usual care, ubrogepant 50\xa0mg, or ubrogepant 100\xa0mg', 'Ubrogepant']","['Safety and tolerability', 'Serious adverse events (SAEs', 'upper respiratory tract infection', 'alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevations', 'migraine headache pain, migraine-associated symptoms, and ability to function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031843', 'cui_str': 'function'}]",1230.0,0.0856448,The most commonly reported TEAE was upper respiratory tract infection (<12%); findings were similar across dose groups.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'Medstar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine and Montefiore Headache Center, Bronx, NY, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hutchinson', 'Affiliation': 'Orange County Migraine & Headache Center, Irvine, CA, USA.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Knievel', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Sung Yun', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Severt', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}]",Headache,['10.1111/head.13682']
839,31944571,Prediction of pathological complete response to neoadjuvant chemotherapy in breast cancer using a deep learning (DL) method.,"BACKGROUND


The aim of the study was to develop a deep learning (DL) algorithm to evaluate the pathological complete response (pCR) to neoadjuvant chemotherapy in breast cancer.
METHODS


A total of 302 breast cancer patients in this retrospective study were randomly divided into a training set (n = 244) and a validation set (n = 58). Tumor regions were manually delineated on each slice by two expert radiologists on enhanced T1-weighted images. Pathological results were used as ground truth. Deep learning network contained five repetitions of convolution and max-pooling layers and ended with three dense layers. The pre-NAC model and post-NAC model inputted six phases of pre-NAC and post-NAC images, respectively. The combined model used 12 channels from six phases of pre-NAC and six phases of post-NAC images. All models above included three indexes of molecular type as one additional input channel.
RESULTS


The training set contained 137 non-pCR and 107 pCR participants. The validation set contained 33 non-pCR and 25 pCR participants. The area under the receiver operating characteristic (ROC) curve (AUC) of three models was 0.553 for pre-NAC, 0.968 for post-NAC and 0.970 for the combined data, respectively. A significant difference was found in AUC between using pre-NAC data alone and combined data (P < 0.001). The positive predictive value of the combined model was greater than that of the post-NAC model (100% vs. 82.8%, P = 0.033).
CONCLUSION


This study established a deep learning model to predict PCR status after neoadjuvant therapy by combining pre-NAC and post-NAC MRI data. The model performed better than using pre-NAC data only, and also performed better than using post-NAC data only.
KEY POINTS


Significant findings of the study. It achieved an AUC of 0.968 for pCR prediction. It showed a significantly greater AUC than using pre-NAC data only. What this study adds This study established a deep learning model to predict PCR status after neoadjuvant therapy by combining pre-NAC and post-NAC MRI data.",2020,"The model performed better than using pre-NAC data only, and also performed better than using post-NAC data only.
","['breast cancer', '302 breast cancer patients']","['neoadjuvant chemotherapy', 'deep learning (DL) algorithm']","['AUC', 'area under the receiver operating characteristic (ROC) curve (AUC']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002045'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",302.0,0.0291485,"The model performed better than using pre-NAC data only, and also performed better than using post-NAC data only.
","[{'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Qu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Zhu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Cao', 'Affiliation': 'Radiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Radiology, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Ying-Shi', 'Initials': 'YS', 'LastName': 'Sun', 'Affiliation': 'Radiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Thoracic cancer,['10.1111/1759-7714.13309']
840,31675174,MRI-Based Radiomics: Associations With the Recurrence-Free Survival of Patients With Hepatocellular Carcinoma Treated With Conventional Transcatheter Arterial Chemoembolization.,"BACKGROUND


Preoperative estimation of hepatocellular carcinoma (HCC) recurrence after conventional transcatheter arterial chemoembolization (c-TACE) is crucial for subsequent follow-up and therapy decisions.
PURPOSE


To evaluate the associations of radiomics models based on pretreatment contrast-enhanced MRI, a clinical-radiological model and a combined model with the recurrence-free survival (RFS) of patients with HCC after c-TACE, and to develop a radiomics nomogram for individual RFS estimations and risk stratification.
STUDY TYPE


Retrospective.
POPULATION


In all, 184 consecutive HCC patients.
FIELD STRENGTH/SEQUENCE


1.5T or 3.0T, including T 2  WI, T 1  WI, and contrast-enhanced T 1  WI.
ASSESSMENT


All HCC patients were randomly divided into the training (n = 110) and validation datasets (n = 74). Radiomics signatures capturing intratumoral and peritumoral expansion (1, 3, and 5 mm) were constructed, and the radiomics models were set up using least absolute shrinkage and selection operator (LASSO) Cox regression. Clinical-radiological features were identified by univariate and multivariate Cox regression. The clinical-radiological model and the combined model fusing the radiomics signature with the clinical-radiological risk factors were developed by a multivariate Cox proportional hazard model. A radiomics nomogram derived from the combined model was established.
STATISTICAL TESTS


LASSO Cox regression, univariate and multivariate Cox regression, Kaplan-Meier analysis were performed. The discrimination performance of each model was quantified by the C-index.
RESULTS


Among the different peritumoral expansion models, only the 3-mm peritumoral expansion model (C-index, 0.714) showed a comparable performance (P = 0.4087) to that of the portal venous phase intratumoral model (C-index, 0.727). The combined model showed the best performance and the C-index was 0.802. Kaplan-Meier analysis showed that the cutoff values of the combined model relative to a median value (1.7426) perfectly stratified these patients into high-risk and low-risk subgroups.
DATA CONCLUSION


The combined model is more valuable than the clinical-radiological model or radiomics model alone for evaluating the RFS of HCC patients after c-TACE, and the radiomics nomogram can be used to preoperatively and individually estimate RFS.
LEVEL OF EVIDENCE


3 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;52:461-473.",2020,"The combined model is more valuable than the clinical-radiological model or radiomics model alone for evaluating the RFS of HCC patients after c-TACE, and the radiomics nomogram can be used to preoperatively and individually estimate RFS.
","['184 consecutive HCC patients', 'patients with HCC after c']","['MRI-Based Radiomics', 'conventional transcatheter arterial chemoembolization (c-TACE', 'Conventional Transcatheter Arterial Chemoembolization', 'TACE']",[],"[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}]",[],184.0,0.0126853,"The combined model is more valuable than the clinical-radiological model or radiomics model alone for evaluating the RFS of HCC patients after c-TACE, and the radiomics nomogram can be used to preoperatively and individually estimate RFS.
","[{'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xiangling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Dajing', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'GE Healthcare, Shanghai, China.'}, {'ForeName': 'Zhuoyue', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Chongqing General Hospital, Chongqing, China.'}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26977']
841,31860326,Sex-Specific Differential Responses of Circulating Biomarkers in Obstructive Sleep Apnea Treatment. A  Post Hoc  Analysis of a Randomized Controlled Trial.,"Rationale : Knowledge of sex-specific changes of cardiovascular biomarkers in response to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) is limited. Objectives : We hypothesized a differential sex-specific cardiovascular biomarker response with CPAP therapy for OSA. Methods : Participants with moderate-severe OSA (apnea-hypopnea index, 15 events/h) were randomized to CPAP versus sham and completed polysomnography and collection of biomarkers of inflammation (myeloperoxidase, fibrinogen, paraoxonase, interleukin [IL]-6, IL-6 soluble receptor, aryl esterase, oxidized low-density lipoprotein, lipoprotein A, plasminogen activator inhibitor 1, and F 2 -isoprostane urine/creatinine ratio) and vascular measures at baseline and 8 weeks of therapy with either CPAP ( n  = 72) or sham treatment ( n  = 70).  Post hoc  secondary analyses of sex-study arm interaction relative to change in inflammatory biomarkers were evaluated via linear regression with adjustment for baseline biomarker value, age, race, body mass, index, waist circumference, and CPAP adherence. Interactions were further evaluated via sex-stratified analyses. Results : The study sample comprised a total of 149 participants aged 50.8 ± 11.7 years; 55% were male, and 55% were white. Participants had a median apnea-hypopnea index of 26.3 events per hour (interquartile range, 13-37). There were substantial interactions between study arm and sex for myeloperoxidase, paraoxonase, and fibrinogen ( P  = 0.03,  P  = 0.03, and  P  = 0.08, respectively). No significant interactions were found for the vascular measures. Estimates were similar but with decreased power in sex-stratified analyses, with decreased biomarkers in women and increased biomarkers in men. Conclusions : Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers, which persisted after adjustment for confounders. These findings set the stage for validation studies and, if confirmed, biochemical pathway elucidation to inform sex-specific personalized treatment approaches.Clinical trial registered with www.clinicaltrials.gov (NCT00607893).",2020,"CONCLUSIONS


Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers which persisted after adjustment for confounders.","['Participants with moderate-severe OSA(apnea-hypopnea index, AHI ≥ 15', '149 participants were aged 50.8±11.7 years, 55% male, 55% white with median AHI 26.3 (IQR:13-37', 'Obstructive Sleep Apnea Treatment', 'obstructive sleep apnea (OSA']","['continuous positive airway pressure (CPAP) therapy', 'CPAP', 'CPAP therapy']","['inflammation (myeloperoxidase, fibrinogen, paroxonase, interleukin(IL)-6, IL-6 soluble receptor, aryl esterase, oxidized LDL, lipoprotein A, plasminogen activator inhibitor-1, and F2-isoprostane urine to creatinine ratio) and vascular measures']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517668', 'cui_str': 'Twenty-six point three'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0014894', 'cui_str': 'Esterases'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein Lp(a)'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0949861', 'cui_str': 'F2-Isoprostanes'}, {'cui': 'C0042037'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429854', 'cui_str': 'Vascular measure'}]",149.0,0.126066,"CONCLUSIONS


Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers which persisted after adjustment for confounders.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio; and.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute.'}, {'ForeName': 'Kingman P', 'Initials': 'KP', 'LastName': 'Strohl', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio; and.'}, {'ForeName': 'Harneet', 'Initials': 'H', 'LastName': 'Walia', 'Affiliation': 'Sleep Disorders Center, Neurologic Institute, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University.'}, {'ForeName': 'Stan L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, and.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Sleep Disorders Center, Neurologic Institute, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201908-593OC']
842,31595704,"Open-Label, Randomized, Single-Dose, 2-Period, 2-Sequence Crossover, Comparative Pharmacokinetic Study to Evaluate Bioequivalence of 2 Oral Formulations of Olanzapine Under Fasting and Fed Conditions.","Olanzapine, a second-generation atypical antipsychotic drug, is widely used for schizophrenia and moderate to severe mania associated with bipolar disorders. This open-label, randomized, single-dose, 2-sequence, 2-period crossover, comparative pharmacokinetic study assessed the bioequivalence of 5 mg of olanzapine administered in tablet (R) or disintegrating tablet (T) formulation in healthy Chinese volunteers under both fasting and fed conditions. Numbers of enrolled subjects were 30 and 24 for fasting and fed treatments, respectively. Blood samples were drawn and collected predose as well as up to 144 hours postdose. The plasma concentration of olanzapine was quantitated by a robust, rapid, and sensitive liquid chromatography-tandem mass spectrometry method. The R was bioequivalent to T formulation under either fasting or fed conditions. The 90%CI for ratios of the geometric means observed maximum plasma concentration, area under the curve from time 0 extrapolated to last time point, and area under the curve from time 0 extrapolated to infinity were all within the allowed limit (80.0% to 125.0%). The pharmacokinetic profiles of T and R formulations were similar under fasting and fed conditions. Both formulations were well tolerated, with a similar incidence of treatment-emergent adverse events under fasting and fed conditions.",2020,"Both formulations were well tolerated, with a similar incidence of treatment-emergent adverse events under fasting and fed conditions.",['healthy Chinese volunteers under both fasting and fed conditions'],"['Olanzapine', 'olanzapine administered in tablet (R) or disintegrating tablet (T) formulation']",['plasma concentration of olanzapine'],"[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]",,0.0149459,"Both formulations were well tolerated, with a similar incidence of treatment-emergent adverse events under fasting and fed conditions.","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Hongchuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Weiyue', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.743']
843,31539053,Energy Availability Is Associated With Luteinizing Hormone Pulse Frequency and Induction of Luteal Phase Defects.,"OBJECTIVE


Determine the interrelations between reductions in energy availability (EA), luteinizing hormone (LH) pulse frequency, and the induction of menstrual disturbances in previously sedentary, ovulatory women.
METHODS


Secondary analysis of a randomized controlled trial consisting of a 3-month controlled diet and supervised exercise program. EA was calculated daily by measured energy intake (kcal) and exercise energy expenditure (kcal) normalized to fat-free mass (kg) and averaged during baseline and each of 3 intervention menstrual cycles. Blood samples were obtained every 10 minutes for 24 hours in the early follicular phase before the intervention and after 3 months of diet and exercise (n = 14). LH pulse dynamics were assessed by Cluster. Linear mixed models determined whether EA predicts LH pulse frequency and LH pulse frequency predicts luteal phase defects (LPDs).
RESULTS


Subjects were 20 ± 1 years old, 165.1 ± 1.4 cm tall, and weighed 58.9 ± 1.5 kg. LH pulse frequency decreased from 0.82 ± 0.06 pulses/h to 0.63 ± 0.09 pulses/h (P = 0.048) as a result of the intervention which produced modest (-3.2 ± 0.6 kg) weight loss. EA, averaged across a menstrual cycle, predicted LH pulse frequency (P = 0.003) such that a single-unit decrease in EA was associated with a 0.017 pulses/h decrease in LH pulse frequency. LH pulse frequency in cycles with LPDs was 49% of that observed in cycles with no menstrual disturbances and for every 0.1-unit decrease in LH pulse frequency, the odds of having an LPD were 22× greater than having an optimal ovulatory cycle (P = 0.01).
CONCLUSIONS


Modest reductions in EA over a prolonged period are associated with decreased LH pulse frequency and the induction of menstrual disturbances.",2020,LH pulse frequency decreased from 0.82±0.06pulses,"['Subjects were 20±1yrs old 165.1±1.4cm tall and weighed 58.9±1.5kg', 'previously sedentary, ovulatory women']",['controlled diet and supervised exercise program'],"['energy intake (kcal) and exercise energy expenditure (kcal) normalized to fat-free mass (kg', 'EA predicts LH pulse frequency and LH pulse frequency predicts luteal phase defects (LPDs', 'energy availability (EA), LH pulse frequency, and the induction of menstrual disturbances', 'LH pulse dynamics', 'LH pulse frequency']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0404576', 'cui_str': 'Luteal phase defect (disorder)'}, {'cui': 'C0025345', 'cui_str': 'Menstruation Disorders'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",,0.0510295,LH pulse frequency decreased from 0.82±0.06pulses,"[{'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Koltun', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'De Souza', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Scheid', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Nancy I', 'Initials': 'NI', 'LastName': 'Williams', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz030']
844,31940011,Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.,"Importance


Behavioral high-risk phenotypes predict the onset of bipolar disorder among youths who have parents with bipolar disorder. Few studies have examined whether early intervention delays new mood episodes in high-risk youths.
Objective


To determine whether family-focused therapy (FFT) for high-risk youths is more effective than standard psychoeducation in hastening recovery and delaying emergence of mood episodes during the 1 to 4 years after an active period of mood symptoms.
Design, Settings, and Participants


This multisite randomized clinical trial included referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II. Recruitment started from October 6, 2011, and ended on September 15, 2016. Independent evaluators interviewed participants every 4 to 6 months to measure symptoms for up to 4 years. Data analysis was performed from March 13 to November 3, 2019.
Interventions


High-risk youths and parents were randomly allocated to FFT (12 sessions in 4 months of psychoeducation, communication training, and problem-solving skills training; n = 61) or enhanced care (6 sessions in 4 months of family and individual psychoeducation; n = 66). Youths could receive medication management in either condition.
Main Outcomes and Measures


The coprimary outcomes, derived using weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery. Secondary outcomes were time to conversion to bipolar disorder I or II and longitudinal symptom trajectories.
Results


All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years) were followed up for a median of 98 weeks (range, 0-255 weeks). No differences were detected between treatments in time to recovery from pretreatment symptoms. High-risk youths in the FFT group had longer intervals from recovery to the emergence of the next mood episode (χ2 = 5.44; P = .02; hazard ratio, 0.55; 95% CI, 0.48-0.92;), and from randomization to the next mood episode (χ2 = 4.44; P = .03; hazard ratio, 0.59; 95% CI, 0.35-0.97) than youths in enhanced care. Specifically, FFT was associated with longer intervals to depressive episodes (log-rank χ2 = 6.24; P = .01; hazard ratio, 0.53; 95% CI, 0.31-0.88) but did not differ from enhanced care in time to manic or hypomanic episodes, conversions to bipolar disorder, or symptom trajectories.
Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes. Clarifying the relationship between changes in family functioning and changes in the course of high-risk syndromes merits future investigation.
Trial Registration


ClinicalTrials.gov identifier: NCT01483391.",2020,"Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes.","['Interventions\n\n\nHigh-risk youths and parents', 'Symptomatic Youths at High Risk for Bipolar Disorder', 'referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II', 'youths who have parents with bipolar disorder', 'All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years', 'high-risk youths']","['Family-Focused Therapy vs Enhanced Usual Care', 'family-focused therapy (FFT', 'psychoeducation, communication training, and problem-solving skills training; n\u2009=\u200961) or enhanced care (6 sessions in 4 months of family and individual psychoeducation', 'standard psychoeducation', 'FFT']","['weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery', 'time to conversion to bipolar disorder I or II and longitudinal symptom trajectories', 'longer intervals to depressive episodes']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]",127.0,0.142508,"Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Suddath', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Forgey Borlik', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private practice, Menlo Park, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4520']
845,31846073,Volumetric facial contour changes of immediately placed implants with and without immediate provisionalization.,"BACKGROUND


Whether immediate provisionalization can preserve facial tissue contour remains undetermined. The goal of this 12-month randomized controlled clinical trial was to compare three-dimensional (3D) ridge changes after immediate implant placement with and without immediate provisionalization.
METHODS


Forty participants with an unrestorable maxillary anterior or premolar tooth were randomized to receive either a provisional crown (test) or standard healing abutment (control) after immediate implant placement. In each participant, three digital models taken before implant surgery, final crown delivery (4 months), and final follow-up (12 months) were registered to analyze linear deviation in 3D and volume changes of ridge contour at the implant site.
RESULTS


The mean value of mid-facial linear 3D spatial resorption ranged from 0.1 to 0.7 mm. Significant difference of linear changes of facial contour was noted over time and not between the groups. Facial volume changes at 12 months remained significantly higher in the control group than in the test group (17.4% versus 11.9%, P = 0.04).
CONCLUSIONS


Linear changes of facial soft-tissue resorption at immediately placed implants were independent of immediate provisionalization. However, immediate provisionalization showed better volume preservation at the esthetic concern area (mid-facial margin and 2 to 6 mm above) at the final 12-month follow-up.",2020,"Facial volume changes at 12 months remained significantly higher in the control group than in the test group (17.4 vs. 11.9%, P = 0.04).
",['Forty participants with an unrestorable maxillary anterior or premolar tooth'],['provisional crown (test) or standard healing abutment (control) after immediate implant placement'],"['3-dimensional (3D) ridge changes', 'linear changes of facial contour', 'mean value of mid-facial linear 3D spatial resorption', 'facial soft-tissue resorption', 'Volumetric facial contour changes', 'Facial volume changes']","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3266125', 'cui_str': 'Healing abutment (physical object)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",40.0,0.0601765,"Facial volume changes at 12 months remained significantly higher in the control group than in the test group (17.4 vs. 11.9%, P = 0.04).
","[{'ForeName': 'I-Ching', 'Initials': 'IC', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}, {'ForeName': 'Hsun-Liang', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Kinney', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}]",Journal of periodontology,['10.1002/JPER.19-0308']
846,31900843,"Effects of montelukast sodium plus budesonide on lung function, inflammatory factors, and immune levels in elderly patients with asthma.","BACKGROUND


Asthma in elderly patients causes excessive suffering and inconvenience. Regimens with better efficacy and less adverse events are still in need of researches.
AIMS


To investigate the effect of montelukast sodium plus budesonide on lung function, inflammatory factors, and immune levels in elderly asthma patients.
METHODS


A total of 180 patients with asthma were assigned into the control group and the observation group. The control group was given aerosol inhalation of budesonide suspension, while the observation group was given budesonide inhalation and oral montelukast sodium. The treatment effect, lung function (forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF)%), inflammatory factors (interleukin (IL)-4, IL-6, and tumor necrosis factor-α (TNF-α)), and immune level (immunoglobulin (Ig) A, and IgE) were analyzed and compared between the two groups.
RESULTS


After treatment, the effective rate was significantly higher in the observation group. The lung function and serum inflammatory factors were improved in both groups. The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower. Patients in both groups showed elevated IgA level and reduced IgE level, and the improvements were more significant in the observation group. There was no significant difference between the two groups in terms of adverse reaction.
CONCLUSIONS


Montelukast sodium plus budesonide has a promising clinical effect on asthma in elderly patients, effectively improves lung function and immunocompetence, and controls inflammatory response, without increasing the adverse reaction.",2020,"The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower.","['180 patients with asthma', 'elderly patients', 'elderly asthma patients', 'elderly patients with asthma', 'elderly patients causes excessive suffering and inconvenience']","['aerosol inhalation of budesonide suspension', 'budesonide inhalation and oral montelukast sodium', 'Montelukast sodium plus budesonide', 'montelukast sodium plus budesonide']","['FEV1, FVC, and PEF', 'elevated IgA level and reduced IgE level', 'lung function, inflammatory factors, and immune levels', 'adverse reaction', 'inflammatory factors IL-4, IL-6, and TNF-α', 'effective rate', 'lung function (forced expiratory volume in 1\xa0s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF)%), inflammatory factors (interleukin (IL)-4, IL-6, and tumor necrosis factor-α (TNF-α)), and immune level (immunoglobulin (Ig) A, and IgE', 'lung function and serum inflammatory factors', 'lung function and immunocompetence, and controls inflammatory response']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0380447', 'cui_str': 'montelukast sodium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020987', 'cui_str': 'Immunologic Competence'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",180.0,0.0356722,"The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory, Zhangye People's Hospital Affiliated to Hexi University, Zhangye, 734000, Gansu, China.""}, {'ForeName': 'Baohong', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory, Zhangye People's Hospital Affiliated to Hexi University, Zhangye, 734000, Gansu, China. libaohong2lb3h@163.com.""}]",Irish journal of medical science,['10.1007/s11845-019-02167-5']
847,31829100,Enriched Marine Oil Supplements Increase Peripheral Blood Specialized Pro-Resolving Mediators Concentrations and Reprogram Host Immune Responses: A Randomized Double-Blind Placebo-Controlled Study.,"RATIONALE


Specialized pro-resolving mediators (SPM-lipoxins, resolvins, protectins, and maresins) are produced via the enzymatic conversion of essential fatty acids, including the omega-3 fatty acids docosahexaenoic acid and n-3 docosapentaenoic acid. These mediators exert potent leukocyte directed actions and control vascular inflammation. Supplementation of animals and humans with essential fatty acids, in particular omega-3 fatty acids, exerts protective actions reducing vascular and systemic inflammation. Of note, the mechanism(s) activated by these supplements in exerting their protective actions remain poorly understood.
OBJECTIVE


Given that essential fatty acids are precursors in the biosynthesises of SPM, the aim of the present study was to establish the relationship between supplementation and peripheral SPM concentrations. We also investigated the relationship between changes in plasma SPM concentrations and peripheral blood platelet and leukocyte responses.
METHODS AND RESULTS


Healthy volunteers were enrolled in a double-blinded, placebo-controlled, crossover study, and peripheral blood was collected at baseline, 2, 4, 6, and 24 hours post administration of placebo or one of 3 doses of an enriched marine oil supplement. Assessment of plasma SPM concentrations using lipid mediator profiling demonstrated a time- and dose-dependent increase in peripheral blood SPM concentration. Supplementation also led to a regulation of peripheral blood cell responses. Here we found a dose-dependent increase in neutrophil and monocyte phagocytosis of bacteria and a decrease in the diurnal activation of leukocytes and platelets, as measured by a reduction in adhesion molecule expression. In addition, transcriptomic analysis of peripheral blood cells demonstrated a marked change in transcript levels of immune and metabolic genes 24 hours post supplementation when compared with placebo.
CONCLUSIONS


Together, these findings demonstrate that supplementation with an enriched marine oil leads to an increase in peripheral blood SPM concentrations and reprograms peripheral blood cells, indicating a role for SPM in mediating the immune-directed actions of this supplement.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT03347006.",2020,Assessment of plasma SPM concentrations using lipid mediator profiling demonstrated a time- and dose-dependent increase in peripheral blood SPM concentration.,['Healthy volunteers'],"['Enriched Marine Oil Supplements', 'placebo or one of 3 doses of an enriched marine oil supplement', 'Placebo', 'placebo']","['neutrophil and monocyte phagocytosis of bacteria', 'peripheral blood cell responses', 'Peripheral Blood Specialized Pro-Resolving Mediators Concentrations and Reprogram Host Immune Responses', 'transcript levels of immune and metabolic genes', 'peripheral blood SPM concentrations', 'peripheral blood SPM concentration', 'plasma SPM concentrations and peripheral blood platelet and leukocyte responses', 'diurnal activation of leukocytes and platelets']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}]",,0.237696,Assessment of plasma SPM concentrations using lipid mediator profiling demonstrated a time- and dose-dependent increase in peripheral blood SPM concentration.,"[{'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Souza', 'Affiliation': 'From the Barts and The London School of Medicine and Dentistry (P.R.S., R.M.M., E.A.G., R.A.C., R.D.M., J.D.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Marques', 'Affiliation': 'From the Barts and The London School of Medicine and Dentistry (P.R.S., R.M.M., E.A.G., R.A.C., R.D.M., J.D.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'Esteban A', 'Initials': 'EA', 'LastName': 'Gomez', 'Affiliation': 'From the Barts and The London School of Medicine and Dentistry (P.R.S., R.M.M., E.A.G., R.A.C., R.D.M., J.D.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'Romain A', 'Initials': 'RA', 'LastName': 'Colas', 'Affiliation': 'From the Barts and The London School of Medicine and Dentistry (P.R.S., R.M.M., E.A.G., R.A.C., R.D.M., J.D.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'De Matteis', 'Affiliation': 'From the Barts and The London School of Medicine and Dentistry (P.R.S., R.M.M., E.A.G., R.A.C., R.D.M., J.D.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zak', 'Affiliation': 'Clinical Research Centre & the NIHR Biomedical Research Centre at Barts (A.Z., M.P., D.J.C.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'Mital', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Clinical Research Centre & the NIHR Biomedical Research Centre at Barts (A.Z., M.P., D.J.C.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Collier', 'Affiliation': 'Clinical Research Centre & the NIHR Biomedical Research Centre at Barts (A.Z., M.P., D.J.C.), Charterhouse Square, Queen Mary University of London, UK.'}, {'ForeName': 'Jesmond', 'Initials': 'J', 'LastName': 'Dalli', 'Affiliation': 'From the Barts and The London School of Medicine and Dentistry (P.R.S., R.M.M., E.A.G., R.A.C., R.D.M., J.D.), Charterhouse Square, Queen Mary University of London, UK.'}]",Circulation research,['10.1161/CIRCRESAHA.119.315506']
848,31843638,Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents.,"Latinx adolescents are at higher risk for chronic diseases relative to adolescents of other ethnic groups, in part because of their lack of adherence to diet recommendations and their higher rates of substance use. Given the proximal influence of family factors during the developmental stage of adolescence, parenting interventions may be an effective way to promote healthy nutrition and substance use prevention simultaneously. This article describes the design and theoretical rationale of a study assessing the effects of Families Preparing the New Generation Plus (FPNG Plus), a 10-week culturally-tailored nutrition and substance use prevention parenting program, on diet and substance use outcomes among Latinx middle school students (6th-8th grade). The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level. Adolescents and parents will complete surveys pre- and post-intervention, and 16-weeks after program participation, regarding diet behaviors, substance use, and parenting practices. A random subsample of 126 dyads (42 from each program), will participate in additional data collection to assess the home food environment, detailed dietary intake (via two 24-h recalls), and provide biomarkers of cardiometabolic risk (blood pressure, total cholesterol and HbA1c). If successful, this study will provide evidence contributing to helping Latinx parents assist their adolescent children develop and maintain long-lasting positive lifestyle behaviors in order to prevent concurrent substance use and diet-related chronic diseases.",2020,"The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level.","['Latinx adolescents', 'Latinx middle school students (6th-8th grade', 'A random subsample of 126 dyads (42 from each program', '1494 parent-child dyads from 18 schools, randomized at the school level']","['parenting intervention', 'FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success']","['cardiometabolic risk (blood pressure, total cholesterol and HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0700132', 'cui_str': 'Academic Success'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",126.0,0.0486669,"The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, United States of America; Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America. Electronic address: Sonia.Vega.Lopez@asu.edu.'}, {'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Lela Rankin', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Bruening', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Anaid', 'Initials': 'A', 'LastName': 'Gonzalvez', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Vega-Luna', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Perilla', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Harthun', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Gabriel Q', 'Initials': 'GQ', 'LastName': 'Shaibi', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America; College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Delgado', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rosario', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann', 'Affiliation': 'College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105914']
849,31837287,Suvorexant to treat alcohol use disorder and comorbid insomnia: Plan for a phase II trial.,"Alcohol use disorder (AUD) is a complex neuropsychiatric disease state in which currently approved pharmacotherapeutics are of relatively low effect at a population level. One reason for this may be that current pharmacotherapeutics focus on the reward pathway in relapse prevention, rather than addressing AUD from a holistic perspective. Importantly, one often overlooked symptom of AUD is sleep disruption. In recent years, an efficient, relatively low risk and economic strategy that has proven successful in other disorders is the repositioning or repurposing of drugs approved for the treatment of other indications. Suvorexant, a dual orexin receptor antagonist, has been licensed for the treatment of insomnia in the USA, Australia and Japan. The orexin system also plays a role in the emotional dysregulation that occurs during withdrawal from alcohol use and in alcohol-seeking behaviours. These two factors prompted the planning of a clinical trial into the use of suvorexant to treat insomnia in alcohol dependent individuals during and 24 weeks post-acute alcohol withdrawal. In this review we outline the comorbid nature of AUD and sleep disruptions. We then highlight the role of the orexin system in both sleep-wake regulation and AUD. Finally, we discuss our plan for a Phase II double blind placebo controlled trial examining the effectiveness of suvorexant for the treatment of comorbid insomnia and AUD.",2020,"Suvorexant, a dual orexin receptor antagonist, has been licensed for the treatment of insomnia in the USA, Australia and Japan.",[],['Suvorexant'],[],[],"[{'cui': 'C3179535', 'cui_str': 'suvorexant'}]",[],,0.03563,"Suvorexant, a dual orexin receptor antagonist, has been licensed for the treatment of insomnia in the USA, Australia and Japan.","[{'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Campbell', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Victoria 3010, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Norman', 'Affiliation': ""St Vincent's Hospital Melbourne, Department of Addiction Medicine, The University of Melbourne, Victoria 3010, Australia.""}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bonomo', 'Affiliation': ""St Vincent's Hospital Melbourne, Department of Addiction Medicine, The University of Melbourne, Victoria 3010, Australia.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lawrence', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Victoria 3010, Australia. Electronic address: andrew.lawrence@florey.edu.au.'}]",Brain research,['10.1016/j.brainres.2019.146597']
850,31840332,Predictors of Adherence to Self-Care in Rural Patients With Heart Failure.,"BACKGROUND


The common reality of not following a recommended course of treatment is a major cause of poor health outcomes in patients with heart failure (HF). The purpose of this study was to identify predictors of adherence to HF self-care recommendations in rural HF patients who received an intervention to promote symptom management and self-care.
METHODS


Data from 349 rural HF patients (42% female, 90% Caucasian) randomized to the intervention arms of the study were used. Adherence was measured using the European Heart Failure Self-Care Scale questionnaire, a brief measure that asks patients to report their adherence to a variety of recommended HF symptom management behaviors (ie, daily weight monitoring, when to call the physician, medications, diet, and exercise). The following predictors were tested: age, gender, marital status, education level, depression score (measured using PHQ-9), anxiety score (measured with the Brief Symptom Inventory), and level of perceived control (measured using Control Attitudes Scale-R). Multivariate linear regression was used to test the model.
RESULTS


The model to predict adherence was significant (P < .0001). Of the covariates tested in the regression model, being a male (P = .009), having less anxiety (P = .018), not being depressed (P = .017), and having higher perceived control (P = .003) were predictors of improved self-care score at 3 months.
CONCLUSION


Adherence is a multifaceted and a challenging behavior based on the assumption that the patient agrees with self-care recommendations. These data suggest interventions designed to promote adherence behaviors should include an assessment of gender, anxiety, depression, and perceived control for optimal outcomes.",2020,"Of the covariates tested in the regression model, being a male (P = .009), having less anxiety (P = .018), not being depressed (P = .017), and having higher perceived control (P = .003) were predictors of improved self-care score at 3 months.
","['Data from 349 rural HF patients (42% female, 90% Caucasian', 'patients with heart failure (HF', 'Rural Patients With Heart Failure', 'rural HF patients who received an intervention to promote symptom management and self-care']",[],"['marital status, education level, depression score (measured using PHQ-9), anxiety score (measured with the Brief Symptom Inventory), and level of perceived control (measured using Control Attitudes Scale-R', 'self-care score', 'European Heart Failure Self-Care Scale questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]",[],"[{'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0222045'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",349.0,0.03791,"Of the covariates tested in the regression model, being a male (P = .009), having less anxiety (P = .018), not being depressed (P = .017), and having higher perceived control (P = .003) were predictors of improved self-care score at 3 months.
","[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Biddle', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Pelter', 'Affiliation': 'School of Nursing, University of California, San Francisco, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Nursing, University of California, San Francisco, California.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': 'School of Nursing, University of California, San Francisco, California.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12405']
851,31830304,Hypothermic to ischemic ratio and mortality in post-cardiac arrest patients.,"BACKGROUND


We studied the associations between ischemia and hypothermia duration, that is, the hypothermic to ischemic ratio (H/I ratio), with mortality in patients included in a trial on two durations of targeted temperature management (TTM) at 33°C.
METHODS


The TTH48 (NCT01689077) trial compared 24 and 48 hours of TTM in patients after cardiac arrest. We calculated the hypothermia time from return of spontaneous circulation (ROSC) until the patient reached 37°C after TTM and the ischemic time from CA to ROSC. We compared continuous variables with the Mann-Whitney U test. Using COX regression, we studied the independent association of the logarithmically transformed H/I ratio and time to death as well as interaction between time to ROSC, hypothermia duration, and intervention group. We visualized the predictive ability of variables with receiver operating characteristic curve analysis.
RESULTS


Of the 338 patients, 237 (70%) survived for 6 months. The H/I ratio was 155 (IQR 111-238) in survivors and 114 (IQR 80-169) in non-survivors (P < .001). In a Cox regression model including factors associated with outcome in univariate analysis, the logarithmically transformed H/I ratio was a significant predictor of outcome (hazard ratio 0.52 (0.37-0.72, P = .001)). After removing an outlier, we found no interaction between time to ROSC and intervention group (P = .55) or hypothermia duration in quartiles (P = .07) with mortality. There was no significant difference in the area under the curve (AUC) between time to ROSC and H/I ratio (ΔAUC 0.03 95% CI -0.006-0.07, P = .10).
CONCLUSIONS


We did not find any consistent evidence of a modification of the effect of TTM based on ischemia duration.",2020,"After removing an outlier, we found no interaction between time to ROSC and intervention group (P = .55) or hypothermia duration in quartiles (P = .07) with mortality.","['in patients after cardiac arrest', 'post-cardiac arrest patients', 'Of the 338 patients, 237 (70%) survived for 6\xa0months']","['Hypothermic', 'TTM']","['area under the curve (AUC', 'ischemic ratio and mortality', 'hypothermia duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",338.0,0.0771708,"After removing an outlier, we found no interaction between time to ROSC and intervention group (P = .55) or hypothermia duration in quartiles (P = .07) with mortality.","[{'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Soreide', 'Affiliation': 'Critical Care and Anaesthesiology Research Group, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Kelly N', 'Initials': 'KN', 'LastName': 'Sawyer', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Valdo', 'Initials': 'V', 'LastName': 'Toome', 'Affiliation': 'Department of Intensive Cardiac Care, North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Internal Medicine, Nephrology and Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christophe H V', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Research Center for Emergency Medicine, Department of Emergency Medicine and Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Tiainen', 'Affiliation': 'Department of Neurology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Aalborg University Hospital, Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Dept of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Department of Emergency Medicine and Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13528']
852,31721185,"Evaluation of Cardiovascular Outcomes in Adult Patients With Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Double-Blind, Placebo-Controlled EVOLVE-1, EVOLVE-2, and REGAIN Studies.","OBJECTIVE


Blood pressure (BP), pulse, electrocardiogram (ECG), and clinical cardiovascular (CV) outcomes in patients with episodic or chronic migraine treated for up to 6 months with galcanezumab compared to placebo were evaluated.
BACKGROUND


Calcitonin gene-related peptide, a potent microvascular vasodilator, has a hypothesized protective role in CV health. Increased CV risks have been reported in patients with migraine.
METHODS


In 2 similarly designed episodic migraine 6-month studies and 1 chronic migraine 3-month study, data from patients randomized (1:1:2) to subcutaneous injection of galcanezumab 120 mg/month (following initial 240 mg loading dose) or 240 mg/month or placebo were pooled. Treatment comparisons for cardiovascular treatment-emergent adverse events (CV TEAE) and categorical and mean changes in BP, pulse, and ECG were evaluated using the Cochran-Mantel-Haenszel test. Mean changes from baseline in BP, pulse, and ECG were evaluated using the analysis of covariance model.
RESULTS


Overall, among galcanezumab 120 mg (n = 705) and 240 mg (n = 730), and placebo (n = 1451) groups, the percentage of patients reporting ≥1 CV TEAE was low and was similar between the galcanezumab 120 mg (2.6%; odds ratio [OR] = 0.9; 95% confidence interval [CI]: 0.5,1.5) and galcanezumab 240 mg (3.3%; OR = 1.1; 95% CI: 0.7,1.9), and placebo (2.9%) groups. The frequency of any individual CV TEAE, broad or narrow term, was ≤1.4%. The CV-related serious adverse events that occurred in the galcanezumab 240 mg group (n = 3; acute myocardial infarction, pulmonary embolism, and transient ischemic attack) and placebo group (n = 3; pulmonary embolism, deep vein thrombosis, and myocardial infarction) were not considered treatment related. Four placebo- and 1 galcanezumab-treated patient discontinued due to a CV TEAE. Least squares mean and categorical changes from baseline in BP, pulse, and QT interval corrected using Fridericia's correction were similar across treatment groups.
CONCLUSIONS


In this 6-month treatment trial, the percentages of galcanezumab- and placebo-treated patients that reported CV TEAEs or serious adverse events were low and similar between groups with few discontinuations. Thus, no clinically meaningful treatment group differences were observed for changes in BP, pulse, or ECG parameters. Additional longer-term studies in a broader and larger cohort are required to better characterize CV safety.",2020,"the percentage of patients reporting ≥1 CV TEAE was low and was similar between the galcanezumab 120 mg (2.6%; odds ratio [OR] = 0.9; 95% confidence interval [CI]: 0.5,1.5) and galcanezumab 240 mg (3.3%; OR = 1.1; 95% CI: 0.7,1.9), and placebo (2.9%) groups.","['patients with episodic or chronic migraine treated for up to 6\xa0months with', 'patients with migraine', 'Adult Patients']","['Placebo', 'galcanezumab- and placebo', 'galcanezumab-treated patient discontinued due to a CV TEAE', 'placebo', 'subcutaneous injection of galcanezumab', 'galcanezumab', 'Galcanezumab']","['acute myocardial infarction, pulmonary embolism, and transient ischemic attack', 'cardiovascular treatment-emergent adverse events (CV TEAE) and categorical and mean changes in BP, pulse, and ECG', 'changes in BP, pulse, or ECG parameters', 'Cardiovascular Outcomes', 'CV TEAEs or serious adverse events', 'BP, pulse, and QT', 'BP, pulse, and ECG', 'pulmonary embolism, deep vein thrombosis, and myocardial infarction', 'Blood pressure (BP), pulse, electrocardiogram (ECG), and clinical cardiovascular (CV) outcomes', 'Increased CV risks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1451.0,0.326349,"the percentage of patients reporting ≥1 CV TEAE was low and was similar between the galcanezumab 120 mg (2.6%; odds ratio [OR] = 0.9; 95% confidence interval [CI]: 0.5,1.5) and galcanezumab 240 mg (3.3%; OR = 1.1; 95% CI: 0.7,1.9), and placebo (2.9%) groups.","[{'ForeName': 'Tina M', 'Initials': 'TM', 'LastName': 'Oakes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kovacs', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Rosen', 'Affiliation': 'Department of Neurology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Phebe', 'Initials': 'P', 'LastName': 'Kemmer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Camporeale', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13684']
853,31909291,Telephone delivered incentives for encouraging adherence to supervised methadone consumption (TIES): Study protocol for a feasibility study for an RCT of clinical and cost effectiveness.,"The majority of people receiving treatment for their heroin addiction, are prescribed methadone; for which there is an extensive evidence base. When treatment starts, people take their daily dose of methadone under supervision at a community pharmacy. Supervision guarantees methadone is taken as directed by the individual for whom it has been prescribed, helps to ensure individuals take their correct dose every day, and safeguards against diversion and overdose. However, individuals often fail to attend the pharmacy to take their methadone. Each missed dose is of concern. If a patient misses their daily dose of methadone, they will start to experience opiate withdrawal and cravings and are more likely to use heroin. If they miss three days dose, there are concerns that they may lose tolerance to the drug and may be at risk of overdose when the next dose is taken. Hence there is an urgent need to develop effective interventions for medication adherence. Research suggests that incentive-based medication adherence interventions may be very effective, but there are few controlled trials and the provision of incentives requires time and organisational systems which can be challenging in pharmacies. The investigators have developed the technology to deliver incentives by mobile telephone. This cluster randomised trial will test the feasibility of conducting a future trial evaluating the clinical and cost effectiveness of using telephone delivered incentives (praise and modest financial rewards via text messaging) to encourage adherence with supervised consumption of methadone in community pharmacies. Three drug services (each with two or three community pharmacies supervising methadone consumption that will enrol 20 individuals, a total of 60 participants) will be recruited and randomly allocated to deliver either i) telephone delivered incentives, ii) telephone delivered reminders or iii) no telephone system. Acceptability, recruitment, follow-up, and suitable measures of clinical and cost effectiveness will be assessed. Findings from this feasibility study will be assessed against stated progression criteria and used to inform a future confirmatory trial of the clinical and cost effectiveness of telephone delivered incentives to encourage medication adherence.
Trial registration


ISRCTN58958179 (retrospectively registered).",2020,This cluster randomised trial will test the feasibility of conducting a future trial evaluating the clinical and cost effectiveness of using telephone delivered incentives (praise and modest financial rewards via text messaging) to encourage adherence with supervised consumption of methadone in community pharmacies.,"['community pharmacies', 'Three drug services (each with two or three community pharmacies supervising methadone consumption that will enrol 20 individuals, a total of 60 participants']","['methadone', 'telephone delivered incentives (praise and modest financial rewards via text messaging', 'i) telephone delivered incentives, ii) telephone delivered reminders or iii) no telephone system', 'methadone consumption (TIES']",[],"[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0557963', 'cui_str': 'Praising (procedure)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}]",[],60.0,0.172659,This cluster randomised trial will test the feasibility of conducting a future trial evaluating the clinical and cost effectiveness of using telephone delivered incentives (praise and modest financial rewards via text messaging) to encourage adherence with supervised consumption of methadone in community pharmacies.,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Metrebian', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Middlesex University, Department of Mental Health, Social Work and Integrative Medicine, School of Health and Education, The Burroughs, London, NW4 4BT, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'University College London, National Collaborating Centre for Mental Health, Research Department of Clinical, Educational and Health Psychology, University College London 1-19 Torrington Place London, WC1 7HB, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Carr', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Woolston-Thomas', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Tas', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Carol-Ann', 'Initials': 'CA', 'LastName': 'Getty', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'van der Waal', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Southwark, Central Acute and Addictions Directorate, Marina House, 63-65 Denmark Hill, London, SE5 8RS, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kelleher', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Southwark, Central Acute and Addictions Directorate, Marina House, 63-65 Denmark Hill, London, SE5 8RS, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Finch', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Southwark, Central Acute and Addictions Directorate, Marina House, 63-65 Denmark Hill, London, SE5 8RS, UK.'}, {'ForeName': 'Prun', 'Initials': 'P', 'LastName': 'Bijral', 'Affiliation': 'Change, Grow, Live, 39-41 Thomas Street, Manchester, M4 1NA, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'University of Bath, Claverton Down, Bath, BA2 7AY, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, Camberwell, London, SE5 8AB, UK.""}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100506']
854,31784435,Factors perceived to facilitate or hinder handwashing among primary students: a qualitative assessment of the Mikono Safi intervention schools in NW Tanzania.,"OBJECTIVE


To qualitatively assess the effects of a multi-modal school-based water, sanitation and hygiene (WASH) intervention on handwashing behaviour among primary students in North Western (NW) Tanzania.
DESIGN


The study was a qualitative assessment of barriers and facilitators to handwashing among students attending primary schools participating in the Mikono Safi Trial (Kiswahili for 'Clean Hands), a cluster-randomised trial assessing the impact of a school-based WASH intervention on selected soil transmitted helminth infections. Data collection methods included in-depth interviews with teachers, focus group discussions and friendship pair interviews with students collected between April and October 2018. The Capability-Opportunity-Motivation and Behaviour model was used to inform data collection and analysis.
SETTING


The study was conducted in four purposively selected intervention schools in three districts of Kagera region, NW Tanzania (Bukoba urban, Bukoba rural and Muleba districts).
PARTICIPANTS


Participants comprised 16 purposively selected teachers aged between 23 and 52 years and 100 students aged 7-15 years RESULTS: The Mikono Safi intervention increased students' reported capability and motivation to wash their hands with soap at key times, particularly after visiting the toilet. Improvements in students' handwashing knowledge and skills were reported by both teachers and students, and motivation for handwashing was enhanced by emotional drivers such as disgust, fear and nurture. Newly established handwashing stations improved the physical opportunity to wash hands, although the availability of water and the provision of soap was not always consistent (eg, due to internal organisational shortcomings or during the dry season). Students and teachers were actively engaged in intervention implementation which created a school community that valued and supported improved hand hygiene.
CONCLUSION


The intervention was successful in improving capability and motivation for handwashing. Handwashing opportunity was also greatly improved, although the supply with water and soap was sometimes interrupted, calling for much stronger multi-sectoral collaboration to improve access to water at schools.
TRIAL REGISTRATION NUMBER


ISRCTN45013173; Pre-results.",2019,"The Mikono Safi intervention increased students' reported capability and motivation to wash their hands with soap at key times, particularly after visiting the toilet.","[""students attending primary schools participating in the Mikono Safi Trial (Kiswahili for 'Clean Hands"", 'primary students in North Western (NW) Tanzania', 'Participants comprised 16 purposively selected teachers aged between 23 and 52 years and 100 students aged 7-15 years RESULTS', 'four purposively selected intervention schools in three districts of Kagera region, NW Tanzania (Bukoba urban, Bukoba rural and Muleba districts']","['school-based WASH intervention', 'Mikono Safi intervention', 'multi-modal school-based water, sanitation and hygiene (WASH) intervention']",['capability and motivation for handwashing'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school (finding)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0274157,"The Mikono Safi intervention increased students' reported capability and motivation to wash their hands with soap at key times, particularly after visiting the toilet.","[{'ForeName': 'Elialilia', 'Initials': 'E', 'LastName': 'Okello', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania elialilia.okello@mitu.or.tz.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Grosskurth', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Makata', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Onike', 'Initials': 'O', 'LastName': 'Mcharo', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinungh'i"", 'Affiliation': 'National Institute for Medical Research (NIMR), Mwanza Centre, Mwanza, Tanzania.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreibelbis', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030947']
855,31877362,Beneficial Effects of Listening to Classical Music in Patients With Heart Failure: A Randomized Controlled Trial.,"BACKGROUND


Practical recommendations on nonpharmacologic non-device/surgical interventions in patients with heart failure (HF) are well known. Although complementary treatments may have beneficial effects, there is no evidence that these on their own improve mortality, morbidity, or quality of life. We examined the effects of listening to recorded classical music on HF-specific quality of life (QOL), generic QOL, sleep quality, anxiety, depression, and cognitive state in patients with HF in the home-care setting.
METHODS AND RESULTS


Multicenter randomized controlled trial. One hundred fifty-nine patients with HF were randomized on a 1:1 basis in 2 groups: experimental (music) and control. Patients were evaluated after 30, 60, 90 days (experimental period) and at 6 months. Patients randomized to the music group listened to music from a large preselected playlist, at least 30 minutes per day, for 3 months on an MP3 player. Patients in the control group received standard care. HF-specific QOL, generic QOL, self-care, somatic perception of HF symptoms, sleep quality, anxiety and depression, and cognitive abilities were assessed throughout the use of specific scales. On average, patients in the music group showed greater improvements in terms of HF-specific QOL (P < .001), generic-QOL (P = .005), quality of sleep (P = .007), anxiety and depression levels (P < .001 for both), and cognitive performances (P = .003).
CONCLUSIONS


Listening to recorded classical music is a feasible, noninvasive, safe, and inexpensive intervention, able to improve QOL in patients with HF in the home-care setting.",2020,"On average, patients in the music group showed greater improvements in terms of HF-specific QOL (P<0.001), generic-QOL (P=0.005), quality of sleep (P=0.007), anxiety and depression levels (P<0.001 for both), and cognitive performances (P=0.003).
","['patients with heart failure', 'patients with heart failure (HF', 'patients with HF in the home-care setting', 'One hundred fifty-nine patients with HF']","['listening to recorded classical music', 'music group listened to music from a large preselected playlist', 'standard care', 'listening to classical music', 'Listening to recorded classical music']","['cognitive performances', 'HF-specific QOL, generic QOL, self-care, somatic perception of HF symptoms, sleep quality, anxiety and depression, and cognitive abilities', 'quality of sleep', 'generic-QOL', 'HF-specific quality of life (QOL), generic QOL, sleep quality, anxiety, depression, and cognitive state', 'mortality, morbidity or quality of life', 'HF-specific QOL', 'anxiety and depression levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",159.0,0.0734823,"On average, patients in the music group showed greater improvements in terms of HF-specific QOL (P<0.001), generic-QOL (P=0.005), quality of sleep (P=0.007), anxiety and depression levels (P<0.001 for both), and cognitive performances (P=0.003).
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Burrai', 'Affiliation': 'Educational and Research, ATS Sardegna-ASSL Sassari, 07100 Sassari, Italy.'}, {'ForeName': 'Giuseppe D', 'Initials': 'GD', 'LastName': 'Sanna', 'Affiliation': 'Clinical and Interventional Cardiology, Sassari University Hospital, 07100 Sassari, Italy. Electronic address: giuseppe.sanna@aousassari.it.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Moccia', 'Affiliation': 'Clinical and Interventional Cardiology, Sassari University Hospital, 07100 Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morlando', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, 20138 Milano, Italy.'}, {'ForeName': 'Eugenio R', 'Initials': 'ER', 'LastName': 'Cosentino', 'Affiliation': 'Department of Internal Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Virna', 'Initials': 'V', 'LastName': 'Bui', 'Affiliation': 'Department of Internal Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Micheluzzi', 'Affiliation': 'Clinical and Interventional Cardiology, Sassari University Hospital, 07100 Sassari, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': 'Department of Internal Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Parodi', 'Affiliation': 'Clinical and Interventional Cardiology, Sassari University Hospital, 07100 Sassari, Italy.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2019.12.005']
856,31765657,Single dose testosterone administration increases impulsivity in the intertemporal choice task among healthy males.,"Circulating levels of testosterone have been positively associated with impulsivity. The present study investigates the effect of testosterone administration on impulsivity in an intertemporal choice task, where participants are given a choice between smaller-sooner rewards and larger-later rewards. Healthy young male participants (n = 111) received a single-dose of 150 mg testosterone gel in a double-blind, placebo-controlled, between-subjects design. At 180 min post-administration, participants performed the decision-making task. Both model-free (i.e., higher indifference point) and model-based (i.e., steeper discounting rate) parameters revealed that testosterone administration increased impulsive choice. This finding supports the hypothesis that exogenous testosterone increases impulsivity among healthy young males in a laboratory task.",2020,"Both model-free (i.e., higher indifference point) and model-based (i.e., steeper discounting rate) parameters revealed that testosterone administration increased impulsive choice.","['healthy males', 'Healthy young male participants (n\u202f=\u202f111', 'healthy young males']","['exogenous testosterone', 'testosterone gel', 'testosterone']","['impulsive choice', 'impulsivity']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsivity'}]",,0.240442,"Both model-free (i.e., higher indifference point) and model-based (i.e., steeper discounting rate) parameters revealed that testosterone administration increased impulsive choice.","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Psychology, Zhejiang Normal University, Jinhua, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Reward, Competition, Dominance and Social Neuroscience Lab, Department of Psychology, School of Social and Behavioral Sciences, Nanjing University, Nanjing, China; Institute for Brain Sciences, Nanjing University, Nanjing, China.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Zilioli', 'Affiliation': 'Institute for Brain Sciences, Nanjing University, Nanjing, China; Department of Psychology, Wayne State University, Detroit, United States; Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, United States.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}]",Hormones and behavior,['10.1016/j.yhbeh.2019.104634']
857,31838334,"How does Community-Led Total Sanitation (CLTS) promote latrine construction, and can it be improved? A cluster-randomized controlled trial in Ghana.","RATIONALE


Open defecation is connected to poor health and child mortality, but billions of people still do not have access to safe sanitation facilities. Community-Led Total Sanitation (CLTS) promotes latrine construction to eradicate open defecation. However, the mechanisms by which CLTS works and how they can be improved remain unknown. The present study is the first to investigate the psychosocial determinants of CLTS in a longitudinal design. Furthermore, we tested whether CLTS can be made more effective by theory- and evidence-based interventions using the risks, attitudes, norms, abilities, and selfregulation (RANAS) model.
METHODS


A cluster-randomized controlled trial of 3216 households was implemented in rural Ghana. Communities were randomly assigned to classic CLTS, one of three RANAS-based interventions, or to the control arm. Prepost surveys at 6-month follow-up included standardized interviews assessing psychosocial determinants from the RANAS model. Regression analyses and multilevel mediation models were computed to test intervention effects and mechanisms of CLTS.
RESULTS


Latrine coverage increased pre-post by 67.6% in all intervention arms and by 7.9% in the control arm (p < .001). The combination with RANAS-based interventions showed non-significantly greater effects than CLTS alone. The effects of CLTS on latrine construction were significantly mediated by changes in four determinants: others' behaviour and approval, self-efficacy, action planning and commitment. Changes in vulnerability, severity, and barrier planning were positively connected to latrine construction but not affected by CLTS.
CONCLUSION


This study corroborates the effectiveness of CLTS in increasing latrine coverage, and additional activities can be improved further. Behaviour change techniques within CLTS that strengthened the relevant factors should be maintained. The study also recommends interventions based on the RANAS approach to improve CLTS. Further research is needed to understand the effects of RANAS-based interventions combined with CLTS at longer follow-up.",2020,"The effects of CLTS on latrine construction were significantly mediated by changes in four determinants: others' behaviour and approval, self-efficacy, action planning and commitment.","['3216 households was implemented in rural Ghana', 'Ghana']","['Community-Led Total Sanitation (CLTS', 'CLTS']","['latrine construction', 'vulnerability, severity, and barrier planning']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}]","[{'cui': 'C0023124', 'cui_str': 'Latrines'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",,0.0327357,"The effects of CLTS on latrine construction were significantly mediated by changes in four determinants: others' behaviour and approval, self-efficacy, action planning and commitment.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Harter', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Ueberlandstrasse 133, 8600, Dübendorf, Switzerland. Electronic address: miriam.harter@eawag.ch.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Inauen', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Ueberlandstrasse 133, 8600, Dübendorf, Switzerland; Department of Psychology, University of Bern, Fabrikstrasse 8, 3012, Bern, Switzerland. Electronic address: jennifer.inauen@eawag.ch.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Mosler', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Ueberlandstrasse 133, 8600, Dübendorf, Switzerland. Electronic address: hans-joachim.mosler@eawag.ch.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.112705']
858,31535359,The Therapeutic Effect of Intravesical Instillation of Platelet Rich Plasma on Recurrent Bacterial Cystitis in Women: A Randomized Clinical Trial.,"PURPOSE


Recurrent bacterial cystitis is a common infection in women and there are concerns about its antibiotic therapy. Platelet rich plasma has antimicrobial and tissue repairing effects. We investigated the effect of platelet rich plasma as an intravesical therapy to prevent recurrence of bacterial cystitis.
MATERIALS AND METHODS


Thirty women with a history of recurrent bacterial cystitis were randomly assigned into two groups: 1) platelet rich plasma and 2) control groups. The first group received 10 mL of platelet rich plasma with intravesical instillation plus 40 mL of normal saline. The control group only received 50 mL of normal saline. We did the instillation once a week for four weeks in both groups. We followed up the participants two and 12 months after the last instillation with a questionnaire (the international consultation on incontinence questionnaire in overactive bladder) and result of their urine culture.
RESULTS


A significant decrease was observed in the number of bacterial cystitis recurrences in the platelet rich plasma group compared to the control group 12 months after the instillation (4 vs. 1, P = 0.004). Also, there was a significant improvement in the questionnaire's score two (3.6 ± 2.58 vs. 0.66 ± 1.63, P = 0.002) and 12 months (3.4 ± 2.77 vs. 0.006 ± 1.83, P < 0.001) after instillation in the platelet rich plasma group compared to control group. There was no adverse effect 12 months after instillation.
CONCLUSION


Platelet rich plasma can significantly decrease the recurrence of bacterial cystitis up to a year after instillation without any side effect.",2019,"A significant decrease was observed in the number of bacterial cystitis recurrences in the platelet rich plasma group compared to the control group 12 months after the instillation (4 vs. 1, P = 0.004).","['recurrent bacterial cystitis in women', 'Thirty women with a history of recurrent bacterial cystitis']","['platelet rich plasma and 2) control groups', '10 mL of platelet rich plasma with intravesical instillation plus 40 mL of normal saline', 'platelet rich plasma', '50 mL of normal saline', 'Materials and Methods']","[""questionnaire's score"", 'number of bacterial cystitis recurrences', 'recurrence of bacterial cystitis']","[{'cui': 'C1959870', 'cui_str': 'Recurrent bacterial cystitis (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0742964', 'cui_str': 'Bladder infection due bacteria'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",30.0,0.0435269,"A significant decrease was observed in the number of bacterial cystitis recurrences in the platelet rich plasma group compared to the control group 12 months after the instillation (4 vs. 1, P = 0.004).","[{'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran. mirzaeimahboubeh@yahoo.com.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Daneshpajooh', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Farsinezhad', 'Affiliation': 'Cell Therapy and Regenerative Medicine Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Jafarian', 'Affiliation': 'Department of Internal Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ebadzadeh', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Saberi', 'Affiliation': 'Isfahan Kidney Transplantation Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Teimorian', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran.'}]",Urology journal,['10.22037/uj.v0i0.5239']
859,31899803,Promising results from an implemented treatment model for paediatric obesity.,"AIM


To investigate the implementation of a plan of action for treatment of childhood obesity, and the effect after 2 years of treatment.
METHODS


Children aged 6-12.9 years who started obesity treatment between 2008 and 2015 in a paediatric clinic in Stockholm County were included. The treatment model included staff education and support and group activities for parents and children separately followed by individual sessions to a multidisciplinary team. The main outcome was change in body mass index standard deviation score (BMI SDS), in comparison to a matched control group.
RESULTS


In the intervention group, 1334 children (52% boys) with an average age of 9.3 years and BMI SDS of 2.7 and 3012 children in the control group were included. The intervention group decreased their BMI SDS more after two years compared with the control group, (-0.31 vs -0.23, P < .001). Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all P < .001) had greater decreases in BMI SDS after 2 years. Sex did not affect the outcome.
CONCLUSION


Even though the treatment in the control group was effective, the implementation of the action plan yielded a better treatment response compared with the control group.",2020,Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all p<0.001) had greater decreases in BMI SDS after two years.,"['paediatric obesity', '1,334 children (52% boys) with an average age of 9.3 years and BMI SDS of 2.7 and 3,012 children in the control group were included', 'Children aged 6-12.9 years who started obesity treatment between 2008-2015 in a paediatric clinic in Stockholm County were included']",[],"['BMI SDS', 'body mass index standard deviation score (BMI SDS']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1334.0,0.0355141,Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all p<0.001) had greater decreases in BMI SDS after two years.,"[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hagman', 'Affiliation': 'Division of Paediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bohlin', 'Affiliation': ""Department of Women's and Children's Health, Södertälje Hospital, Sodertalje, Sweden.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Klaesson', 'Affiliation': ""Department of Women's and Children's Health, Södertälje Hospital, Sodertalje, Sweden.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ejderhamn', 'Affiliation': ""Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Danielsson', 'Affiliation': 'Division of Paediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15158']
860,31899529,Effectiveness of Virtual vs In-Person Inhaler Education for Hospitalized Patients With Obstructive Lung Disease: A Randomized Clinical Trial.,"Importance


Many patients who are hospitalized cannot use inhalers correctly, yet education for their use is often not provided. To address the need for an effective intervention feasible for wide-scale implementation, a virtual teach-to-goal intervention was developed to provide tailored patient-directed education using adaptive learning technology.
Objective


To assess whether the virtual teach-to-goal intervention is noninferior to an in-person teach-to-goal intervention for improving inhaler technique.
Design, Setting, and Participants


An equivalence and noninferiority randomized clinical trial took place from January 13, 2016, through September 20, 2017, with analyses conducted between October 25, 2017, and September 23, 2019. Adult inpatients with asthma or chronic obstructive pulmonary disease (COPD) admitted to general inpatient wards were eligible. Enrolled participants were randomized to virtual (n = 61) or in-person (n = 60) educational interventions. Investigators and research assistants were masked to interventions. Initial enrollment, study assessments, and delivery of the educational intervention occurred in the hospital; participants returned at 30 days for a follow-up research visit.
Interventions


Virtual education was a module delivered via handheld tablet with self-assessment questions before demonstration, narrated video demonstration of the correct technique, and self-assessment questions after demonstration; up to 3 rounds were repeated as needed. In-person education participants received iterative rounds of inhaler technique assessment and education by trained staff.
Main Outcomes and Measures


Noninferiority testing of whether virtual vs in-person education achieved an equal percentage with correct inhaler technique after education (>9 of 12 steps correct) against an a priori noninferiority limit of -10%; logistic regression models were used to adjust for differences in baseline technique and health literacy.
Results


Among 118 participants (59 in each group), most were black (114 [97%]) and female (76 [64%]), with a mean (SD) age of 54.5 (13.0) years. Correct technique increased similarly before vs after education in virtual (67%; range, 2%-69%) and in-person (66%; range, 17% to 83%) groups, although the difference after intervention exceeded the noninferiority limit (-14%; 95% CI lower bound, -26%). When adjusting for baseline inhaler technique, the difference was equivalent to the noninferiority limit (-10%; 95% CI lower bound, -22%).
Conclusions and Relevance


The findings suggest that patient-directed virtual education similarly improved the percentage of participants with correct technique compared with in-person education. Future work should confirm whether virtual teach-to-goal education is noninferior to in-person education and whether it is associated with long-term skills retention, medication adherence, and improved health outcomes.
Trial Registration


ClinicalTrials.gov identifier: NCT02611531.",2020,"Correct technique increased similarly before vs after education in virtual (67%; range, 2%-69%) and in-person (66%; range, 17% to 83%) groups, although the difference after intervention exceeded the noninferiority limit (-14%; 95% CI lower bound, -26%).","['Hospitalized Patients With Obstructive Lung Disease', '118 participants (59 in each group', 'Adult inpatients with asthma or chronic obstructive pulmonary disease (COPD) admitted to general inpatient wards were eligible', 'January 13, 2016, through September 20, 2017, with analyses conducted between October 25, 2017, and September 23, 2019']","['person (n\u2009=\u200960) educational interventions', 'Virtual vs In-Person Inhaler Education']","['Correct technique', 'noninferiority limit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600260', 'cui_str': 'Obstructive Pulmonary Diseases'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",118.0,0.201069,"Correct technique increased similarly before vs after education in virtual (67%; range, 2%-69%) and in-person (66%; range, 17% to 83%) groups, although the difference after intervention exceeded the noninferiority limit (-14%; 95% CI lower bound, -26%).","[{'ForeName': 'Valerie G', 'Initials': 'VG', 'LastName': 'Press', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Vineet M', 'Initials': 'VM', 'LastName': 'Arora', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Kelly', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Carey', 'Affiliation': 'Section of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Steve R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'Section of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18205']
861,31873952,Changes in systemic and subcutaneous adipose tissue inflammation and oxidative stress in response to exercise training in obese black African women.,"KEY POINTS


Inflammation and oxidative stress are interrelated during obesity and contribute to the development of insulin resistance; and exercise training represents a key component in the management of these conditions. Black African women, despite high gluteal subcutaneous adipose tissue (SAT) and less visceral fat, are less insulin sensitive than their white counterparts. Exercise training improved systemic oxidative stress in obese black women, which was related to gynoid fat reduction and not insulin sensitivity. Inflammatory markers changed depot-specifically in response to exercise training, increasing in gluteal SAT without changing in abdominal SAT. The increase of inflammatory state in gluteal SAT after exercise training is suggested to result from tissue remodelling consecutive to the reduction of gynoid fat but does not contribute to the improvement of whole-body insulin sensitivity in obese black South African women.
ABSTRACT


Inflammation and oxidative stress are interrelated during obesity and contribute to the development of insulin resistance. Exercise training represents a key component in the management of obesity. We evaluated the effects of 12 weeks' combined resistance and aerobic exercise training on systemic and abdominal vs. gluteal subcutaneous adipose tissue (SAT) inflammatory and oxidative status in obese black South African women. Before and after the intervention, body composition (dual energy X-ray absorptiometry), cardio-respiratory fitness (  VO   2   peak      ), serum and SAT inflammatory and oxidative stress markers were measured from 15 (control group) and 20 (exercise group) women and insulin sensitivity (S I  ; frequently sampled intravenous glucose tolerance test) was estimated. Following the intervention,  VO   2   peak      (9.8%), body fat composition (1-3%) and S I  (9%) improved, serum thiobarbituric acid reactive substances (TBARS) decreased (6.5%), and catalase activity increased (23%) in the exercise compared to the control group (P < 0.05), without changes in circulating inflammatory markers. The mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor increased in the gluteal SAT exercise compared to the control group P < 0.05), with no changes in abdominal SAT. These changes of inflammatory profile in gluteal SAT, in addition to the reduction of circulating TBARS, correlated with the reduction of gynoid fat, but not with the improvement of S I  . The changes in systemic oxidative stress markers and gluteal SAT inflammatory genes correlated with the reduction in gynoid fat but were not directly associated with the exercise-induced improvements in S I  .",2020,"The mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor increased in the gluteal SAT exercise compared to the control group P < 0.05), with no changes in abdominal SAT.","['obese black African women', 'Black African women', 'obese black women', 'obese black South African women']","['exercise training', 'Exercise training', ""12\xa0weeks' combined resistance and aerobic exercise training""]","['gluteal SAT exercise', 'abdominal SAT', 'systemic oxidative stress markers and gluteal SAT inflammatory genes', 'systemic and abdominal vs. gluteal subcutaneous adipose tissue (SAT) inflammatory and oxidative status', 'catalase activity', 'body fat composition', 'body composition (dual energy X-ray absorptiometry), cardio-respiratory fitness (  VO   2   peak      ), serum and SAT inflammatory and oxidative stress markers', 'serum thiobarbituric acid reactive substances (TBARS', 'circulating inflammatory markers', 'systemic oxidative stress', 'insulin sensitivity (S', 'mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337824', 'cui_str': 'Black African (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0024429', 'cui_str': 'Migration Inhibition Factors, Macrophage'}]",,0.0197529,"The mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor increased in the gluteal SAT exercise compared to the control group P < 0.05), with no changes in abdominal SAT.","[{'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Nono Nankam', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melony F', 'Initials': 'MF', 'LastName': 'De Smidt', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Dheshnie', 'Initials': 'D', 'LastName': 'Keswell', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Medicine, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}]",The Journal of physiology,['10.1113/JP278669']
862,31854292,Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT.,"BACKGROUND


People with serious mental illness have sexual health needs, but there is limited evidence regarding effective interventions to promote their sexual health.
OBJECTIVES


To develop a sexual health promotion intervention for people with serious mental illness, and to conduct a feasibility trial in order to establish the acceptability and parameters for a fully powered trial.
DESIGN


A two-armed randomised controlled, open feasibility study comparing usual care alone with usual care plus the adjunctive intervention.
SETTING


Five community mental health providers in Leeds, Barnsley, Brighton and London.
PARTICIPANTS


Adults aged ≥ 18 years with serious mental illness and receiving care from community mental health teams.
INTERVENTIONS


A remote, web-based computer randomisation system allocated participants to usual care plus the RESPECT (Randomised Evaluation of Sexual health Promotion Effectiveness informing Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm). The intervention was an interactive manualised package of exercises, quizzes and discussion topics focusing on knowledge, motivation and behavioural intentions to adopt safer sexual behaviours.
MAIN OUTCOME MEASURES


Feasibility parameters including establishing the percentage of people who were eligible, consented and were retained in each arm of the trial, retention for the intervention, as well as the completeness of the data collection. Data were collected on knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life. Data were collected at baseline and then at 3 months and 6 months post randomisation.
RESULTS


Of a target of 100 participants, 72 people participated in the trial over 12 months. Of the 36 participants randomised to the intervention arm, 27 received some of the intervention (75.0%). At 3 months, 59 of the 72 participants completed follow-up questionnaires (81.9%) (30 participants from the intervention arm and 29 participants from the control arm). Only the first 38 participants were followed up at 6 months. However, data were collected on 29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm. No adverse events were reported. Participant feedback confirmed that both the design and the intervention were acceptable. The economic analysis indicated high completion rates and completeness of data among participants who continued the trial.
CONCLUSIONS


Despite the limitations, the findings suggest that it is both acceptable and feasible to undertake a sexual health promotion study for people with serious mental illness.
FUTURE WORK


A fully powered randomised controlled trial would be required to establish the clinical effectiveness of the intervention.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN15747739.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 65. See the NIHR Journals Library website for further project information.",2019,No adverse events were reported.,"['29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm', 'Adults aged ≥\u200918 years with serious mental illness and receiving care from community mental health teams', 'people with serious mental illness', 'Five community mental health providers in Leeds, Barnsley, Brighton and London', '72 people participated in the trial over 12 months', 'people with severe mental illness', '100 participants', 'People with serious mental illness']","['sexual health promotion intervention', 'usual care alone with usual care plus the adjunctive intervention', 'Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm']","['Sexual health promotion', 'adverse events', 'knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life']","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}]",100.0,0.130031,No adverse events were reported.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gascoyne', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Thirimon', 'Initials': 'T', 'LastName': 'Moe-Byrne', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Edmondson', 'Affiliation': 'Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Lottie', 'Initials': 'L', 'LastName': 'Millett', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Dare', 'Affiliation': 'Expert by experience, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Primary Care and Public Health, University of Sussex, Brighton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Nolan', 'Affiliation': 'School of Health and Social Care, University of Essex, Colchester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Walker', 'Affiliation': 'Expert by experience, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23650']
863,30792141,Dietary supplement of tomato can accelerate urinary aMT6s level and improve sleep quality in obese postmenopausal women.,"The aim of this study was to investigate the effect of the ingestion of tomato before bed on obese postmenopausal women's urinary 6-sulphatoxymelatonin (aMT6s) level and sleep quality. We quantified melatonin concentrations in beefsteak tomato, black tomato, and two commercial tomato juices and found that beefsteak tomato contained the highest level of melatonin. In this 8-week open-label, randomized controlled dietary intervention trial, 36 subjects completed the entire trial. The tomato group ate 250 g of beefsteak tomatoes 2 h before sleep for 8 weeks. Blood and urine samples were collected at the baseline and in the 8th week and were analyzed. The Pittsburgh Sleep Quality Index (PSQI) in the tomato group significantly decreased with time (p for trend = 0.0297). After 8 weeks of the beefsteak intervention, all components of the PSQI in tomato group had significantly improved, and their aMT6s level was 10-fold significantly higher than that of the control group. Therefore, supplementation with beefsteak tomato before sleep can increase circulating melatonin and improve sleep quality in obese postmenopausal women.",2020,The Pittsburgh Sleep Quality Index (PSQI) in the tomato group significantly decreased with time (p for trend = 0.0297).,"[""obese postmenopausal women's"", '36 subjects completed the entire trial', 'obese postmenopausal women']",[],"['Pittsburgh Sleep Quality Index (PSQI', 'Blood and urine samples', 'urinary aMT6s level', 'urinary 6-sulphatoxymelatonin (aMT6s) level and sleep quality', 'sleep quality', 'aMT6s level']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}]",[],"[{'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0005768'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0049713', 'cui_str': '6-hydroxymelatoninsulfate'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",36.0,0.0302334,The Pittsburgh Sleep Quality Index (PSQI) in the tomato group significantly decreased with time (p for trend = 0.0297).,"[{'ForeName': 'Ting-Hsuan', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'Department of Nutrition and Health Sciences, Taipei Medical University, Taipei, 11031, Taiwan.'}, {'ForeName': 'Yi Chun', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition and Health Sciences, Taipei Medical University, Taipei, 11031, Taiwan.'}, {'ForeName': 'Tzu-Hsuan', 'Initials': 'TH', 'LastName': 'Ou', 'Affiliation': 'Department of Nutrition and Health Sciences, Taipei Medical University, Taipei, 11031, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chien', 'Affiliation': 'Department of Nutrition and Health Sciences, Taipei Medical University, Taipei, 11031, Taiwan; Graduate Institute of Metabolism and Obesity, College of Nutrition, Taipei Medical University, Taipei, 11031, Taiwan. Electronic address: ychien@tmu.edu.tw.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.009']
864,31881390,Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.,"BACKGROUND


Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own.
OBJECTIVES


The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention).
METHODS


PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum.
DISCUSSION


This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
TRIAL REGISTRATION


National Clinical Trial (NCT) Identifier: NCT03925883.",2020,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
","['collaboration with a large community health center whose patient population is 37% Latino', 'community health centers', 'Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy']","['targeted navigation program', 'precision health intervention', 'patient navigation or usual care']","['overall and by probability stratum', 'time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers', 'colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.111953,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA. Electronic address: Gloria.D.Coronado@kpchr.org.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Johnson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Schneider', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Mummadi', 'Affiliation': 'Northwest Permanente Medical Group, Portland, OR, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Jimenez', 'Affiliation': 'Sea Mar Community Health Centers, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105920']
865,31364169,A randomised controlled trial of treatments of childhood anxiety disorder in the context of maternal anxiety disorder: clinical and cost-effectiveness outcomes.,"BACKGROUND


This study evaluated whether clinical and economic outcomes from CBT for child anxiety disorders in the context of maternal anxiety disorders are improved by adding treatment focused on (a) maternal anxiety disorders or (b) mother-child interactions.
METHODS


Two hundred and eleven children (7-12 years, 85% White British, 52% female) with a primary anxiety disorder, whose mothers also had a current anxiety disorder, were randomised to receive (a) child-focused CBT with nonspecific control interventions (CCBT+Con), (b) CCBT with CBT for the maternal anxiety disorder (CCBT+MCBT), or (c) CCBT with an intervention targeting the mother-child interaction (CCBT+MCI). A cost-utility analysis from a societal perspective was conducted using mother/child combined quality-adjusted life years (QALYs). [Trial registration: https://doi.org/10.1186/isrctn19762288].
RESULTS


MCBT was associated with immediate reductions in maternal anxiety compared to the nonspecific control; however, after children had also received CCBT, maternal outcomes in the CCBT+MCI and CCBT+Con arms improved and CCBT+MCBT was no longer superior. Neither CCBT+MCBT nor CCBT+MCI conferred a benefit over CCBT+Con in terms of child anxiety disorder diagnoses post-treatment [primary outcome] (adj RR: 1.22 (95% CI: 0.88, 1.67), p = .23; adj RR: 1.21 (95% CI: 0.88, 1.65), p = .24, respectively) or global improvement ratings (adj RR: 1.25 (95% CI: 0.99, 1.57), p = .06; adj RR: 1.18 (95% CI: 0.93, 1.50), p = .17) or six and 12 months later. No significant differences between the groups were found on the main economic outcome measures (child/mother combined QALY mean difference: CCBT+MCBT vs. CCBT+Con: -0.04 (95% CI: -0.12, 0.04), p = .29; CCBT+MCI vs. CCBT+Con: 0.02 (95% CI: -0.05, -0.09), p = .54). CCBT+MCI was associated with nonsignificantly higher costs than CCBT (mean difference: £154 (95% CI: -£1,239, £1,547), p = .83) but, when taking into account sampling uncertainty, it may be cost-effective compared with CCBT alone.
CONCLUSIONS


Good outcomes were achieved for children and their mothers across treatment arms. There was no evidence of significant clinical benefit from supplementing CCBT with either CBT for the maternal anxiety disorder or treatment focussed on mother-child interactions, but the addition of MCI (and not MCBT) may be cost-effective.",2020,"No significant differences between the groups were found on the main economic outcome measures (child/mother combined QALY mean difference: CCBT+MCBT vs. CCBT+Con: -0.04 (95% CI: -0.12, 0.04), p = .29; CCBT+MCI vs. CCBT+Con: 0.02","['Two hundred and eleven children (7-12\xa0years, 85% White British, 52% female) with a primary anxiety disorder, whose mothers also had a current anxiety disorder', 'childhood anxiety disorder in the context of maternal anxiety disorder']","['CCBT+Con', 'CBT with nonspecific control interventions (CCBT+Con), (b) CCBT with CBT for the maternal anxiety disorder (CCBT+MCBT), or (c) CCBT with an intervention targeting the mother-child interaction (CCBT+MCI', 'CBT', 'CCBT+MCBT']","['maternal anxiety', 'global improvement ratings', 'child anxiety disorder diagnoses']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1278523', 'cui_str': 'White British'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",211.0,0.0783766,"No significant differences between the groups were found on the main economic outcome measures (child/mother combined QALY mean difference: CCBT+MCBT vs. CCBT+Con: -0.04 (95% CI: -0.12, 0.04), p = .29; CCBT+MCI vs. CCBT+Con: 0.02","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Creswell', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Violato', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cruddace', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'Population, Policy and Practice, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Willetts', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, Berkshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Cooper', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13089']
866,30685298,"Consumption of whole grain/bran rye instead of refined wheat decrease concentrations of TNF-R2, e-selectin, and endostatin in an exploratory study in men with prostate cancer.","BACKGROUND & AIMS


Rye consumption has shown beneficial effects on prostate cancer tumors, as indicated by slower initial tumor growth in animal models and lowering of prostate-specific antigen (PSA) in humans. This study evaluated the effects of whole grain/bran rye consumption on low-grade inflammation and endothelial function biomarkers in men with prostate cancer.
METHODS


Seventeen men with untreated, low-grade prostate cancer consumed 485 g rye whole grain and bran products (RP) per day or refined wheat products with added cellulose (WP) in a randomized crossover design. Fasting blood samples were taken before and after 2, 4, and 6 weeks of treatment.
RESULTS


Concentrations of tumor nuclear factor-receptor 2 (TNF-R2), e-selectin, and endostatin were significantly lower after consumption of the RP diet compared with WP (p < 0.05). Cathepsin S concentration was positively correlated to TNF-R2 and endostatin concentrations across all occasions. Strong correlations were consistently found between intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) and between interleukin-6 (IL-6) and interleukin-1 receptor antagonist (IL-1RA). No effect of intervention was found in 92 inflammation-related protein biomarkers measured in a proximity extension assay.
CONCLUSIONS


RP diet lowered TNF-R2, e-selectin, and endostatin, compared with WP in men with prostate cancer. These effects were accompanied by a reduction in PSA.",2020,Strong correlations were consistently found between intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) and between interleukin-6 (IL-6) and interleukin-1 receptor antagonist (IL-1RA).,"['Seventeen men with untreated, low-grade prostate cancer consumed 485\xa0g', 'men with prostate cancer']","['rye whole grain and bran products (RP) per day or refined wheat products with added cellulose (WP', 'whole grain/bran rye consumption', 'Consumption of whole grain/bran rye']","['TNF-R2, e-selectin, and endostatin', '92 inflammation-related protein biomarkers', 'low-grade inflammation and endothelial function biomarkers', 'nuclear factor-receptor 2 (TNF-R2), e-selectin, and endostatin', 'intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) and between interleukin-6 (IL-6) and interleukin-1 receptor antagonist (IL-1RA', 'Fasting blood samples', 'TNF-R2 and endostatin concentrations', 'Cathepsin S concentration']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1140674', 'cui_str': 'Rye'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0353942', 'cui_str': 'Bran'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0255813', 'cui_str': 'Receptors, Tumor Necrosis Factor, Type II'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0534628', 'cui_str': 'Endostatins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0054874', 'cui_str': 'cathepsin S'}]",17.0,0.022095,Strong correlations were consistently found between intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) and between interleukin-6 (IL-6) and interleukin-1 receptor antagonist (IL-1RA).,"[{'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Zamaratskaia', 'Affiliation': 'Swedish University of Agricultural Sciences, Department of Molecular Sciences, Box, 7015, Uppsala, Sweden.'}, {'ForeName': 'Nor Adila', 'Initials': 'NA', 'LastName': 'Mhd Omar', 'Affiliation': 'Unit of Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden. Electronic address: nor.adila.mhd.omar@ki.se.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Brunius', 'Affiliation': 'Swedish University of Agricultural Sciences, Department of Molecular Sciences, Box, 7015, Uppsala, Sweden; Department of Biology and Biological Engineering, Division of Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Hallmans', 'Affiliation': 'Department of Public Health and Clinical Medicine, Nutritional Research, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Johansson', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Sven-Olof', 'Initials': 'SO', 'LastName': 'Andersson', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Akademiska Sjukhuset, Ing.40, 5 tr, Uppsala, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Åman', 'Affiliation': 'Swedish University of Agricultural Sciences, Department of Molecular Sciences, Box, 7015, Uppsala, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Unit of Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden; Department of Public Health and Clinical Medicine, Nutritional Research, Umeå University, Umeå, Sweden; Department of Biology and Biological Engineering, Division of Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.01.007']
867,30704890,Vitamin B complex supplementation as a homocysteine-lowering therapy for early stage diabetic nephropathy in pediatric patients with type 1 diabetes: A randomized controlled trial.,"BACKGROUND


Homocysteine levels are elevated in patients with type 1 diabetes mellitus (T1DM) and could induce renal injury. B vitamins have an important role in preventing microvascular complications of diabetes.
AIM


We performed a randomized-controlled trial of oral supplementation with vitamin B complex as an adjuvant therapy for nephropathy in pediatric T1DM patients and assessed its relation to homocysteine and cystatin C as a marker of nephropathy.
METHODS


This trial included 80 T1DM patients with microalbuminuria, despite oral angiotensin-converting enzyme inhibitors, aged 12-18 years with at least 5 years disease duration and HbA1c ≤8.5%. Patients were randomly assigned into two groups; intervention group which received oral vitamin B complex (B1, B6 and B12) once daily and placebo group. Both groups were followed-up for 12 weeks with assessment of plasma homocysteine, HbA1c, urinary albumin excretion (UAE) and cystatin C.
RESULTS


Both groups were well-matched in baseline clinical and laboratory parameters. Baseline homocysteine levels were elevated in both groups compared with reference control values. After 12 weeks, supplementation with vitamin B complex for the intervention group resulted in a significant decrease of homocysteine, fasting blood glucose, HbA1c, triglycerides, total cholesterol, UAE and cystatin C compared with baseline levels (p < 0.001) and with placebo group (p < 0.001). No adverse reactions were reported. Baseline cystatin C was negatively correlated to vitamin B12 (r = -0.77, p = 0.001).
CONCLUSIONS


Vitamin B complex improved glycemic control and renal function through decreasing homocysteine and could be a safe and effective strategy for treatment of early stage nephropathy in pediatric T1DM. This trial was registered at ClinicalTrials.gov (NCT03594240).",2020,No adverse reactions were reported.,"['80 T1DM patients with microalbuminuria, despite oral angiotensin-converting enzyme inhibitors, aged 12-18 years with at least 5 years disease duration and HbA1c ≤8.5', 'nephropathy in pediatric T1DM patients', 'patients with type 1 diabetes mellitus (T1DM', 'pediatric patients with type 1 diabetes']","['oral supplementation with vitamin B complex', 'placebo', 'homocysteine-lowering therapy', 'Vitamin B complex', 'Vitamin B complex supplementation', 'oral vitamin B complex (B1, B6 and B12) once daily and placebo', 'B vitamins']","['Baseline homocysteine levels', 'vitamin B12 (r', 'glycemic control and renal function', 'homocysteine, fasting blood glucose, HbA1c, triglycerides, total cholesterol, UAE and cystatin C', 'adverse reactions', 'plasma homocysteine, HbA1c, urinary albumin excretion (UAE) and cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4524017', 'cui_str': 'Vitamin B complex supplementation'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}]","[{'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",80.0,0.528868,No adverse reactions were reported.,"[{'ForeName': 'Nancy Samir', 'Initials': 'NS', 'LastName': 'Elbarbary', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: nancy_elbarbary@med.asu.edu.eg.'}, {'ForeName': 'Eman Abdel Rahman', 'Initials': 'EAR', 'LastName': 'Ismail', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mamdouh Ahmed', 'Initials': 'MA', 'LastName': 'Zaki', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ahram Canadian University, Cairo, Egypt.'}, {'ForeName': 'Yasser Wagih', 'Initials': 'YW', 'LastName': 'Darwish', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Marwa Zaki', 'Initials': 'MZ', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ahram Canadian University, Cairo, Egypt.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'El-Hamamsy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.01.006']
868,30827722,Arabinoxylan oligosaccharides and polyunsaturated fatty acid effects on gut microbiota and metabolic markers in overweight individuals with signs of metabolic syndrome: A randomized cross-over trial.,"BACKGROUND & AIMS


Gut microbiota composition is linked to obesity and metabolic syndrome. The nutrients and doses required to modulate the gut microbiota towards beneficially influence components of the metabolic syndrome are unclear. This study aimed to investigate diet-induced effects on the gut microbiota and metabolic markers in overweight individuals with indices of the metabolic syndrome.
METHODS


A twelve-week randomized cross-over trial was conducted with two intervention periods separated by a washout period. The dietary intakes of interest were wheat bran extract, rich in arabinoxylan oligosaccharides (AXOS) (10.4 g/d AXOS) and polyunsaturated fatty acids (PUFA) (3.6 g/d n-3 PUFA). Dietary records, fecal and blood samples, as well as anthropometric data, were collected before and after intervention. Anthropometry and gastrointestinal symptoms were evaluated weekly. Gut microbiota composition was analyzed by massive sequencing of 16S ribosomal RNA gene V3V4 amplicons.
RESULTS


Twenty-seven participants completed the study (90%). Intake of AXOS induced an expected bifidogenic effect on gut microbiota (p < 0.01) and increased butyrate-producing bacterial species as well (p < 0.05). Beta-diversity analysis indicated that the structure of the gut microbiota only changed as a result of the AXOS intervention (Permanova = 1.90, p < 0.02) and no changes in metabolic markers were observed after any of the interventions.
CONCLUSIONS


AXOS intake has a bifidogenic effect and also increases butyrate producers in the gut microbiota; even though this type of dietary fiber did not modulate lipid or glucose metabolic parameters related to metabolic syndrome. Four-week PUFA intake did not induce any notable effect on the gut microbiota composition or metabolic risk markers.
REGISTRATION


Registered under ClinicalTrials.gov Identifier no. NCT02215343.
CLINICAL TRIAL REGISTRATION


Registered at https://www.clinicaltrials.gov/ (NCT02215343).
ETHICAL COMMITTEE


H-4-2014-052.
THE DANISH DATA PROTECTION AGENCY


2013-54-0522.",2020,Intake of AXOS induced an expected bifidogenic effect on gut microbiota (p < 0.01) and increased butyrate-producing bacterial species as well (p < 0.05).,"['AGENCY\n\n\n2013-54-0522', 'overweight individuals with indices of the metabolic syndrome', 'COMMITTEE\n\n\nH-4-2014-052', 'Twenty-seven participants completed the study (90', 'overweight individuals with signs of metabolic syndrome']","['polyunsaturated fatty acids (PUFA', 'wheat bran extract, rich in arabinoxylan oligosaccharides (AXOS', 'Arabinoxylan oligosaccharides and polyunsaturated fatty acid effects']","['Gut microbiota composition', 'butyrate-producing bacterial species', 'gut microbiota and metabolic markers', 'gut microbiota composition or metabolic risk markers', 'Anthropometry and gastrointestinal symptoms', 'bifidogenic effect on gut microbiota', 'metabolic markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]","[{'cui': 'C3257534', 'cui_str': 'Triticum vulgare extract'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker (substance)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",27.0,0.0426857,Intake of AXOS induced an expected bifidogenic effect on gut microbiota (p < 0.01) and increased butyrate-producing bacterial species as well (p < 0.05).,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kjølbæk', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark. Electronic address: louisekjoelbaek@nexs.ku.dk.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Benítez-Páez', 'Affiliation': 'Microbial Ecology, Nutrition & Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC), 46980, Paterna, Valencia, Spain. Electronic address: abenitez@iata.csic.es.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Gómez Del Pulgar', 'Affiliation': 'Microbial Ecology, Nutrition & Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC), 46980, Paterna, Valencia, Spain.'}, {'ForeName': 'Lena K', 'Initials': 'LK', 'LastName': 'Brahe', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Liebisch', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Matysik', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rampelli', 'Affiliation': 'Microbial Ecology of Health Unit, Department of Pharmacy and Biotechnology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vermeiren', 'Affiliation': 'Cargill R&D Centre Europe, Havenstraat 84, B-1800 Vilvoorde, Belgium.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Brigidi', 'Affiliation': 'Microbial Ecology of Health Unit, Department of Pharmacy and Biotechnology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Lesli H', 'Initials': 'LH', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sanz', 'Affiliation': 'Microbial Ecology, Nutrition & Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC), 46980, Paterna, Valencia, Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.01.012']
869,29566730,Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial.,"BACKGROUND


The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA).
METHODS/DESIGN


The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months.
DISCUSSION


This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa.
TRIAL REGISTRATION


South African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015.",2018,"Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions.","['Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm', 'hypertensive patients withcomorbid depression attending PHC facilities in South Africa', '20 largest eligible clinics from one district in the North West Province are enrolled in the trial', 'adults with hypertension in South Africa', 'hypertensive patients attending primary health care (PHC) facilities in South Africa (SA']","['Collaborative care', 'strengthened training', 'standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care', 'strengtheneddepression identification and collaborative management']",['PHQ-9 score'],"[{'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1000.0,0.118325,"Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions.","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa. peterseni@ukzn.ac.za.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Folb', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': 'Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK.'}, {'ForeName': 'Babalwa', 'Initials': 'B', 'LastName': 'Zani', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Selohilwe', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa.'}, {'ForeName': 'Ruwayda', 'Initials': 'R', 'LastName': 'Petrus', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa.'}, {'ForeName': 'Ntokozo', 'Initials': 'N', 'LastName': 'Mntambo', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Georgeu-Pepper', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tasneem', 'Initials': 'T', 'LastName': 'Kathree', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa.'}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Department of Population Health and Primary Care, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gaziano', 'Affiliation': 'Department of Health Policy and Management, Harvard University, Cambridge, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Levitt', 'Affiliation': 'Department of Diabetic Medicine and Endocrinology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Fairall', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-018-2518-6']
870,31849155,Effects of nicorandil infusion on ECG parameters in patients with unstable angina pectoris and percutaneous coronary intervention.,"BACKGROUND


Percutaneous coronary intervention (PCI) is effective in treating patients with acute coronary syndrome (ACS) but is associated with some serious complications. Nicorandil is an anti-anginal agent acting to improve microvascular circulation and to increase coronary blood flow. The objective of this article is to evaluate the effects of intracoronary injection followed with continuous intravenous injection of nicorandil on ECG parameters in patients with unstable angina pectoris (UA) undergoing PCI.
METHODS


A single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019. Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled. ECG was recorded and analyzed before and 24 hr after nicorandil infusion.
RESULTS


Patients were divided into three groups: control group (n = 23, aged 63.43 ± 12.55 years), short-term, and prolonged use with nicorandil group (n = 20 and 20, aged 66.45 ± 8.06 years and 65.80 ± 9.49 years, respectively). Clinical characteristics and ECG parameters were similar before PCI among three groups (p > .05). In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
CONCLUSIONS


Nicorandil infusion reduces QTd and Tp-e interval in patients with UA. Further studies will be needed to determine whether these electrophysiological changes are associated with a reduction of ventricular arrhythmias and improved outcomes.",2020,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
","['patients with unstable angina pectoris and percutaneous coronary intervention', 'patients with unstable angina pectoris (UA) undergoing PCI.\nMETHODS\n\n\nA single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019', 'patients with acute coronary syndrome (ACS', 'Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled', 'Patients were divided into three groups: control group (n\xa0=\xa023, aged 63.43\xa0±\xa012.55\xa0years), short-term, and prolonged use with nicorandil group (n\xa0=\xa020 and 20, aged 66.45\xa0±\xa08.06\xa0years and 65.80\xa0±\xa09.49\xa0years, respectively', 'patients with UA']","['Percutaneous coronary intervention (PCI', 'nicorandil', 'nicorandil infusion', 'Nicorandil', 'intracoronary injection']","['coronary blood flow', 'intervals of QTd and Tp-e', 'QTd and Tp-e interval', 'Clinical characteristics and ECG parameters', 'ECG parameters', 'ECG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",63.0,0.0131258,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
","[{'ForeName': 'Weiding', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Kangyin', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Tse', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Guangping', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12736']
871,31888378,Laboratory Findings After Urinary Tract Infection and Antimicrobial Prophylaxis in Children With Vesicoureteral Reflux.,"It is a common practice to monitor blood tests in patients receiving long-term trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis for recurrent urinary tract infections. This multicenter, randomized, placebo-controlled trial enrolled 607 children aged 2 to 71 months with vesicoureteral reflux diagnosed after symptomatic urinary tract infection. Study participants received TMP-SMZ (n = 302) or placebo (n = 305) and were followed for 2 years. Serum electrolytes (n ≥ 370), creatinine (n = 310), and complete blood counts (n ≥ 206) were measured at study entry and at the 24-month study conclusion. We found no significant electrolyte, renal, or hematologic abnormalities when comparing the treatment and placebo groups. We observed changes in several laboratory parameters in both treatment and placebo groups as would normally be expected with physiologic maturation. Changes were within the normal range for age. Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine. Our findings do not support routine monitoring of these laboratory tests in children receiving long-term TMP-SMZ prophylaxis.",2020,"Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine.","['patients receiving long-term', 'Children With Vesicoureteral Reflux', 'children receiving long-term TMP-SMZ prophylaxis', '607 children aged 2 to 71 months with vesicoureteral reflux diagnosed after symptomatic urinary tract infection']","['placebo', 'TMP-SMX', 'trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis', 'TMP-SMZ']","['Serum electrolytes (n ≥ 370), creatinine (n = 310), and complete blood counts (n ≥ 206', 'complete blood count, serum electrolytes, or creatinine', 'significant electrolyte, renal, or hematologic abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteral Reflux'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",607.0,0.253822,"Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine.","[{'ForeName': 'Milan Dattaram', 'Initials': 'MD', 'LastName': 'Nadkarni', 'Affiliation': 'Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Tej K', 'Initials': 'TK', 'LastName': 'Mattoo', 'Affiliation': ""Children's Hospital of Michigan, Detroit, MI, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gravens-Mueller', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Myra A', 'Initials': 'MA', 'LastName': 'Carpenter', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marva', 'Initials': 'M', 'LastName': 'Moxey-Mims', 'Affiliation': ""Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Saul P', 'Initials': 'SP', 'LastName': 'Greenfield', 'Affiliation': 'State University of New York at Buffalo, NY, USA.'}, {'ForeName': 'Ranjiv', 'Initials': 'R', 'LastName': 'Mathews', 'Affiliation': 'Southern Illinois University, Springfield, IL, USA.'}]",Clinical pediatrics,['10.1177/0009922819898185']
872,31815640,Correction to: Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial.,"After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2]. We would like to formally apologize and give credit to the authors of that article [2]: Chris Smith, Uk Vannak, Ly Sokhey, Thoai D Ngo, Judy Gold, Khemrin Khut, Phil Edwards, Tung Rathavy and Caroline Free.",2019,"Chris Smith, Uk Vannak, Ly Sokhey, Thoai D Ngo, Judy Gold, Khemrin Khut, Phil Edwards, Tung Rathavy and Caroline Free.",['female entertainment workers in Cambodia'],['Mobile Link - a theory-based messaging intervention'],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0881422,"Chris Smith, Uk Vannak, Ly Sokhey, Thoai D Ngo, Judy Gold, Khemrin Khut, Phil Edwards, Tung Rathavy and Caroline Free.","[{'ForeName': 'Carinne', 'Initials': 'C', 'LastName': 'Brody', 'Affiliation': 'Public Health Program, College of Education and Health Sciences, Touro, University California, Vallejo, CA, USA.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Tuot', 'Affiliation': 'KHANA Center for Population Health, Research, No. 33, Street 71, Phnom Penh, Cambodia.'}, {'ForeName': 'Pheak', 'Initials': 'P', 'LastName': 'Chhoun', 'Affiliation': 'KHANA Center for Population Health, Research, No. 33, Street 71, Phnom Penh, Cambodia.'}, {'ForeName': 'Dallas', 'Initials': 'D', 'LastName': 'Swendeman', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Kathryn C', 'Initials': 'KC', 'LastName': 'Kaplan', 'Affiliation': 'KHANA Center for Population Health, Research, No. 33, Street 71, Phnom Penh, Cambodia.'}, {'ForeName': 'Siyan', 'Initials': 'S', 'LastName': 'Yi', 'Affiliation': 'Public Health Program, College of Education and Health Sciences, Touro, University California, Vallejo, CA, USA. siyan@doctor.com.'}]",Trials,['10.1186/s13063-019-3941-z']
873,31805983,Investigating modifications to participant information materials to improve recruitment into a large randomized trial.,"BACKGROUND


Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants' response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it.
METHODS


Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2-THRIVE is registered at ClinicalTrials.gov (NCT00461630).
RESULTS


The commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94-1.17) and 1.10 (95% CI 0.94-1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33).
CONCLUSIONS


Many reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.",2019,"However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33).
",['Participants who declined to participate in the HPS2-THRIVE trial'],[],[],"[{'cui': 'C2938208', 'cui_str': 'Thrive'}]",[],[],,0.180909,"However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wincott', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rejive', 'Initials': 'R', 'LastName': 'Dayanandan', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lay', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parish', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bowman', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK. jane.armitage@ndph.ox.ac.uk.'}]",Trials,['10.1186/s13063-019-3779-4']
874,31852019,Editorial Comment to Ultraslow full-power shock wave lithotripsy versus slow power-ramping shock wave lithotripsy in stones with high attenuation value: A randomized comparative study.,,2020,,['stones with high attenuation value'],['Ultraslow full-power shock wave lithotripsy versus slow power-ramping shock wave lithotripsy'],[],"[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0348053', 'cui_str': 'Ramping (qualifier value)'}]",[],,0.0209822,,"[{'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Taguchi', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14165']
875,31329503,Postural Stability in Patients with Lower Limb Lymphedema.,"Background:  Impaired mobility and musculoskeletal dysfunctions are commonly seen in patients with lymphedema and can affect the balance system in patients in whom the lower limb is affected. This study aims at comparing postural stability between patients with lower limb lymphedema (LLL) and healthy subjects.  Methods and Results:  This controlled study included 36 patients with LLL (LLL group) and 36 healthy subjects (control group). Fall risk, stability index, and Fourier index measurements of Tetrax ®  Interactive Balance System were compared. There were no statistically significant differences between groups in terms of demographics parameters ( p  > 0.05). Some stability and Fourier index measurements were significantly higher in subjects in the LLL group than in the control group. However, the fall risk was not statistically different in patients with LLL than healthy subjects ( p  > 0.05).  Conclusion:  LLL may cause balance impairments. However, this impairment may not lead to increased fall risk. The evaluation of postural stability in LLL patients would be a useful addition to routine clinical practice due to the relationship between LLL and balance impairments.",2019,"However, the fall risk was not statistically different in patients with LLL than healthy subjects ( p  > 0.05).  ","['patients with lymphedema', 'patients with lower limb lymphedema (LLL) and healthy subjects', 'LLL patients', '36 patients with LLL (LLL group) and 36 healthy subjects (control group', 'Patients with Lower Limb Lymphedema']",['LLL'],"['Fall risk, stability index, and Fourier index measurements of Tetrax ®  Interactive Balance System', 'stability and Fourier index measurements', 'Postural Stability', 'Impaired mobility and musculoskeletal dysfunctions', 'fall risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0518456', 'cui_str': 'Physical mobility impairment'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",36.0,0.0227722,"However, the fall risk was not statistically different in patients with LLL than healthy subjects ( p  > 0.05).  ","[{'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Doruk Analan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Kaya', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Adana City Training and Research Hospital, Adana, Turkey.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0004']
876,31329507,Effectiveness of Kinesio Taping on Anastomotic Regions in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Pilot Study.,"Background:  The purpose of the study was to investigate the effect of using Kinesio Taping ®  (KT) on anastomotic regions along with complex decongestive physiotherapy (CDP) in patients with breast cancer-related lymphedema (BCRL).  Methods and Results:  Patients with unilateral BCRL were divided into two groups in this randomized controlled study: Group 1 (CDP,  n  = 14) and Group 2 (CDP+ KT,  n  = 18). Assessment of limb size was quantified by using circumferential limb measurements and then calculated for each segment by using the frustum formula. CDP included manual lymphatic drainage, compression bandages, exercises, and skin care. KT was applied to lymphatic anastomosis. All patients received treatment for 1 hour per day, 5 days per week for 4 weeks. The outcome measure was difference in the reduction of limb volumes between the groups. There was a significant difference in both groups before and after treatment ( p  < 0.05), but there was no significant difference between the two groups regarding changes in limb volume ( p  > 0.05).  Conclusion:  The results suggest that applying KT to lymphatic anastomotic regions is not effective in reducing limb volume in the management of BCRL.",2019,The results suggest that applying KT to lymphatic anastomotic regions is not effective in reducing limb volume in the management of BCRL.,"['Patients with unilateral BCRL', 'Patients with Breast Cancer-Related Lymphedema', 'patients with breast cancer-related lymphedema (BCRL']","['complex decongestive physiotherapy (CDP', 'Kinesio Taping', 'Kinesio Taping ®  (KT']","['limb size', 'limb volume', 'reduction of limb volumes', 'manual lymphatic drainage, compression bandages, exercises, and skin care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0010724', 'cui_str': 'CDP'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0556834', 'cui_str': 'Manual Lymphatic Drainage'}, {'cui': 'C0677875', 'cui_str': 'Compression Wraps'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}]",,0.025077,The results suggest that applying KT to lymphatic anastomotic regions is not effective in reducing limb volume in the management of BCRL.,"[{'ForeName': 'Gülbin', 'Initials': 'G', 'LastName': 'Ergin', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Science Faculty, European University of Lefke, Lefke, North Cyprus.'}, {'ForeName': 'Ertan', 'Initials': 'E', 'LastName': 'Şahinoğlu', 'Affiliation': 'Dr. İsmail Atabek Physical Therapy and Rehabilitation Center, İzmir, Turkey.'}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Karadibak', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, İzmir, Turkey.'}, {'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Yavuzşen', 'Affiliation': 'Institute for Oncology, Dokuz Eylul University, İzmir, Turkey.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0003']
877,31338563,"A Vitamin D, Calcium and Leucine-Enriched Whey Protein Nutritional Supplement Improves Measures of Bone Health in Sarcopenic Non-Malnourished Older Adults: The PROVIDE Study.","Alterations in musculoskeletal health with advanced age contribute to sarcopenia and decline in bone mineral density (BMD) and bone strength. This decline may be modifiable via dietary supplementation. To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of bone health. Participants (n 380) were participants of the PROVIDE study, a 13-week, multicenter, randomized, controlled, double-blind, 2 parallel-group study among non-malnourished older participants (≥ 65 years) with sarcopenia [determined by Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index (SMI; skeletal muscle mass/BW × 100) ≤ 37% in men and ≤ 28% in women using bioelectric impedance analysis] Supplementation of a vitamin D, calcium and leucine-enriched whey protein drink that comprises a full range of micronutrients (active; 2/day) was compared with an iso-caloric control. Serum 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH), biochemical markers of bone formation (osteocalcin; OC, procollagen type 1 amino-terminal propeptide; P1NP) and resorption (carboxy-terminal collagen crosslinks; CTX), insulin like growth factor 1 (IGF-1) and total-body BMD were analysed pre- and post-intervention. Serum 25(OH)D concentrations increased from 51.1 ± 22.9 nmol/L (mean ± SD) to 78.9 ± 21.1 nmol/L in the active group (p < 0.001 vs. control). Serum PTH showed a significant treatment difference (p < 0.001) with a decline in the active group, and increase in the control group. Serum IGF-1 increased in the active group (p < 0.001 vs. control). Serum CTX showed a greater decline in the active group (p = 0.001 vs. control). There were no significant differences in serum OC or P1NP between groups during the intervention. Total body BMD showed a small (0.02 g/cm 2 ; ~ 2%) but significant increase in the active group after supplementation (p = 0.033 vs. control). Consuming a vitamin D, calcium and leucine-enriched whey protein supplement for 13 weeks improved 25(OH)D, suppressed PTH and had small but positive effects on BMD, indicative of improved bone health, in sarcopenic non-malnourished older adults.",2019,"Serum PTH showed a significant treatment difference (p < 0.001) with a decline in the active group, and increase in the control group.","['Participants (n 380', 'Sarcopenic Non-Malnourished Older Adults', 'malnourished older participants (≥', '65\xa0years) with sarcopenia [determined by Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index (SMI; skeletal muscle mass/BW\u2009×\u2009100', 'sarcopenic non-malnourished older adults']","['Whey Protein Nutritional Supplement', 'vitamin D, calcium and leucine-enriched whey protein supplement', 'Vitamin D, Calcium and Leucine-Enriched', 'vitamin D, calcium and leucine-enriched whey protein drink']","['Total body BMD', 'bone health', 'Serum IGF-1', 'serum OC or P1NP', 'bone mineral density (BMD) and bone strength', 'Serum PTH', 'BMD, indicative of improved bone health', 'Bone Health', 'Serum 25(OH)D concentrations', 'Serum 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH), biochemical markers of bone formation (osteocalcin; OC, procollagen type 1 amino-terminal propeptide; P1NP) and resorption (carboxy-terminal collagen crosslinks; CTX), insulin like growth factor 1 (IGF-1) and total-body BMD']","[{'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]",380.0,0.237198,"Serum PTH showed a significant treatment difference (p < 0.001) with a decline in the active group, and increase in the control group.","[{'ForeName': 'Tom R', 'Initials': 'TR', 'LastName': 'Hill', 'Affiliation': 'Institute of Cellular Medicine, Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK. Tom.hill@ncl.ac.uk.'}, {'ForeName': 'Sjors', 'Initials': 'S', 'LastName': 'Verlaan', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Uppsalalaan 12, Utrecht Science Park, Utrecht, 3584 CT, The Netherlands.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Biesheuvel', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Uppsalalaan 12, Utrecht Science Park, Utrecht, 3584 CT, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, Metabolic Bone Centre, Northern General Hospital, University of Sheffield, Sheffield, S5 7AU, UK.'}, {'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Bauer', 'Affiliation': 'Department of Geriatric Medicine, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Brandt', 'Affiliation': 'Institute of Cellular Medicine, Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Lorenzo M', 'Initials': 'LM', 'LastName': 'Donini', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Maggio', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Parma, Italy.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mets', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Seal', 'Affiliation': 'Institute of Cellular Medicine, Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Sander Lj', 'Initials': 'SL', 'LastName': 'Wijers', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Uppsalalaan 12, Utrecht Science Park, Utrecht, 3584 CT, The Netherlands.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Institute for Biomedicine on Ageing, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences/Clinical Nutrition and Metabolism, Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Aspray', 'Affiliation': 'Bone Clinic, Institute of Cellular Medicine, Freeman Hospital, Newcastle University, Newcastle upon Tyne, NE7 7DE, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Calcified tissue international,['10.1007/s00223-019-00581-6']
878,30345498,Comparison of Classic and Inguinal Obturator Nerve Blocks Applied for Preventing Adductor Muscle Contractions in Bladder Tumor Surgeries: A Prospective Randomized Trial.,"PURPOSE


Obturator nerve block (ONB) has been performed in surgeries of transurethral resection of bladder tumors (TUR-BT) for the prevention of the development of obturator muscle contraction. Currently, classic and inguinal approaches are frequently being used. In the present study, we aimed to compare the success rate, performance speed, and complication risks of both approaches.
MATERIALS AND METHODS


Sixty-six patients who underwent TUR-BT under spinal anesthesia were randomly selected, and ONB was performed on the tumor location side using classic (n = 33) or inguinal (n = 33) approaches. Ten milliliters of 0.25% bupivacaine were administered using a peripheral nerve stimulator in both approaches.Two endpoints were defined in the study: Primary endpoint; the duration of the determination of the obturator nerve and number of interventions when each participant is assessed in at the end of the ONB procedure. Secondary endpoint; development of contractions, and complications each participant is assessed during the TUR-BT and 24 hours after ONB. (Clinical Trial Registration Number: ACTRN12617001050347)Result: General anesthesia was applied to the five patients in the classic ONB group who detected diffuse or bilateral tumors. These patients were excluded from the study. Contractions developed in 4 patients in each group, no statistically significant difference was detected between the groups (14.3%, n = 4 versus 12.1%, n = 4) (P = 1.00). No complications were detected in both groups during the TUR-BT and 24 hours after ONB. We found that the inguinal approach provided a statistically significant advantage regarding the number of punctures (1.9 ± 0.9 versus1.5 ± 0.7) (P = .036), and duration of the procedure (99.1 ± 48.4 seconds versus 76.0 ± 31.9 seconds) (P=.029) compared with the classic approach.
CONCLUSION


Although complications and success rates were similar in both groups, the inguinal method may be abetter approach because it is faster and requires fewer punctures.",2019,"Contractions developed in 4 patients in each group, no statistically significant difference was detected between the groups (14.3%, n = 4 versus 12.1%, n = 4) (P = 1.00).","['Bladder Tumor Surgeries', 'Sixty-six patients who underwent TUR-BT under spinal anesthesia were randomly selected, and ONB was performed on the tumor location side using classic (n = 33) or inguinal (n = 33) approaches', 'five patients in the classic ONB group who detected diffuse or bilateral tumors']","['Obturator nerve block (ONB', 'Classic and Inguinal Obturator Nerve Blocks', 'bupivacaine']","['Contractions', 'success rate, performance speed, and complication risks', 'duration of the determination of the obturator nerve and number of interventions', 'contractions, and complications each participant is assessed during the TUR-BT and 24 hours after ONB', 'complications and success rates']","[{'cui': 'C0005695', 'cui_str': 'Bladder Tumors'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0394741', 'cui_str': 'Local anesthetic obturator nerve block (procedure)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0028783', 'cui_str': 'Obturator Nerve'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]",66.0,0.0535178,"Contractions developed in 4 patients in each group, no statistically significant difference was detected between the groups (14.3%, n = 4 versus 12.1%, n = 4) (P = 1.00).","[{'ForeName': 'Recai', 'Initials': 'R', 'LastName': 'Dagli', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey. drresel@gmail.com.'}, {'ForeName': 'Mumtaz', 'Initials': 'M', 'LastName': 'Dadali', 'Affiliation': 'Department of Urology, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Emir', 'Affiliation': 'Department of Urology, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Bagbanci', 'Affiliation': 'Department of Urology, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kirsehir, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4176']
879,32028090,In-kind incentives and health worker performance: Experimental evidence from El Salvador.,"We experimentally evaluated the effects of in-kind team incentives on health worker performance in El Salvador, with 38 out of 75 community health teams randomly assigned to performance incentives over a 12-month period. All teams received monitoring, performance feedback and recognition for their achievements allowing us to isolate the effect of the incentive. While both treatment and control groups exhibit improvements in performance measures over time, the in-kind incentives generated significant improvements in community outreach, quality of care, timeliness of care, and utilization of maternal and child health services after 12 months. Gains were largest for teams at the bottom and top of the baseline performance distribution. We find no evidence of results being driven by changes in reporting or by shifting away effort from non-contracted outcomes. These results suggest that in-kind team incentives may be a viable alternative to monetary or individual incentives in certain contexts.",2020,"While both treatment and control groups exhibit improvements in performance measures over time, the in-kind incentives generated significant improvements in community outreach, quality of care, timeliness of care, and utilization of maternal and child health services after 12 months.","['El Salvador, with 38 out of 75 community health teams']",[],"['community outreach, quality of care, timeliness of care, and utilization of maternal and child health services', 'health worker performance']","[{'cui': 'C0013754', 'cui_str': 'El Salvador'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]",[],"[{'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",75.0,0.0663259,"While both treatment and control groups exhibit improvements in performance measures over time, the in-kind incentives generated significant improvements in community outreach, quality of care, timeliness of care, and utilization of maternal and child health services after 12 months.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bernal', 'Affiliation': 'Inter-American Development Bank, 1300 New York Avenue, NW, Washington, DC, 20577, United States. Electronic address: pbernallara@iadb.org.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Inter-American Development Bank, 1300 New York Avenue, NW, Washington, DC, 20577, United States. Electronic address: smartinez@iadb.org.'}]",Journal of health economics,['10.1016/j.jhealeco.2019.102267']
880,31318392,Durvalumab With or Without Tremelimumab for Patients With Metastatic Pancreatic Ductal Adenocarcinoma: A Phase 2 Randomized Clinical Trial.,"Importance


New therapeutic options for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) are needed. This study evaluated dual checkpoint combination therapy in patients with mPDAC.
Objective


To evaluate the safety and efficacy of the anti-PD-L1 (programmed death-ligand 1) antibody using either durvalumab monotherapy or in combination with the anticytotoxic T-lymphocyte antigen 4 antibody using durvalumab plus tremelimumab therapy in patients with mPDAC.
Design, Setting, and Participants


Part A of this multicenter, 2-part, phase 2 randomized clinical trial was a lead-in safety, open-label study with planned expansion to part B pending an efficacy signal from part A. Between November 26, 2015, and March 23, 2017, 65 patients with mPDAC who had previously received only 1 first-line fluorouracil-based or gemcitabine-based treatment were enrolled at 21 sites in 6 countries. Efficacy analysis included the intent-to-treat population; safety analysis included patients who received at least 1 dose of study treatment and for whom any postdose data were available.
Interventions


Patients received durvalumab (1500 mg every 4 weeks) plus tremelimumab (75 mg every 4 weeks) combination therapy for 4 cycles followed by durvalumab therapy (1500 mg every 4 weeks) or durvalumab monotherapy (1500 mg every 4 weeks) for up to 12 months or until the onset of progressive disease or unacceptable toxic effects.
Main Outcomes and Measures


Safety and efficacy were measured by objective response rate, which was used to determine study expansion to part B. The threshold for expansion was an objective response rate of 10% for either treatment arm.
Results


Among 65 randomized patients, 34 (52%) were men and median age was 61 (95% CI, 37-81) years. Grade 3 or higher treatment-related adverse events occurred in 7 of 32 patients (22%) receiving combination therapy and in 2 of 32 patients (6%) receiving monotherapy; 1 patient randomized to the monotherapy arm did not receive treatment owing to worsened disease. Fatigue, diarrhea, and pruritus were the most common adverse events in both arms. Overall, 4 of 64 patients (6%) discontinued treatment owing to treatment-related adverse events. Objective response rate was 3.1% (95% CI, 0.08-16.22) for patients receiving combination therapy and 0% (95% CI, 0.00-10.58) for patients receiving monotherapy. Low patient numbers limited observation of the associations between treatment response and PD-L1 expression or microsatellite instability status.
Conclusion and Relevance


Treatment was well tolerated, and the efficacy of durvalumab plus tremelimumab therapy and durvalumab monotherapy reflected a population of patients with mPDAC who had poor prognoses and rapidly progressing disease. Patients were not enrolled in part B because the threshold for efficacy was not met in part A.
Trial Registration


ClinicalTrials.gov identifier: NCT02558894.",2019,"Objective response rate was 3.1% (95% CI, 0.08-16.22) for patients receiving combination therapy and 0% (95% CI, 0.00-10.58) for patients receiving monotherapy.","['Patients With Metastatic Pancreatic Ductal Adenocarcinoma', 'patients who received at least 1 dose of study treatment and for whom any postdose data were available', '65 randomized patients, 34 (52%) were men and median age was 61 (95% CI, 37-81) years', 'Between November 26, 2015, and March 23, 2017, 65 patients with mPDAC who had previously received only 1 first-line fluorouracil-based or gemcitabine-based treatment were enrolled at 21 sites in 6 countries', 'patients with mPDAC who had poor prognoses and rapidly progressing disease', 'patients with metastatic pancreatic ductal adenocarcinoma (mPDAC', 'patients with mPDAC']","['tremelimumab', 'durvalumab', 'durvalumab monotherapy', 'durvalumab plus tremelimumab therapy', 'dual checkpoint combination therapy', 'durvalumab therapy', 'monotherapy', 'anti-PD-L1 (programmed death-ligand 1) antibody using either durvalumab monotherapy', 'Durvalumab With or Without Tremelimumab']","['adverse events', 'Objective response rate', 'objective response rate', 'Fatigue, diarrhea, and pruritus', 'Measures\n\n\nSafety and efficacy', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",65.0,0.0873355,"Objective response rate was 3.1% (95% CI, 0.08-16.22) for patients receiving combination therapy and 0% (95% CI, 0.00-10.58) for patients receiving monotherapy.","[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Gastrointestinal Medical Oncology, David M. Rubenstein Center for Pancreatic Cancer, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Neesha', 'Initials': 'N', 'LastName': 'Dhani', 'Affiliation': 'Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Renouf', 'Affiliation': 'Medical Oncology, BC Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Myung Ah', 'Initials': 'MA', 'LastName': 'Lee', 'Affiliation': ""Department of Oncology, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Weijing', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Division of Medical Oncology, University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fisher', 'Affiliation': 'Department of Medicine-Medical Oncology, Stanford University, Stanford, California.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Hezel', 'Affiliation': 'Division of Hematology and Oncology, University of Rochester, Rochester, New York.'}, {'ForeName': 'Shao-Chun', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Vlahovic', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Takahashi', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitts', 'Affiliation': 'Independent Biostatistician, Durham, North Carolina.'}, {'ForeName': 'Philip Agop', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Department of Oncology, Barbara Ann Karmanos Cancer Institute, Detroit, Michigan.'}]",JAMA oncology,['10.1001/jamaoncol.2019.1588']
881,31309547,Interventions for morphea.,"BACKGROUND


Morphea (morphoea) is an immune-mediated disease in which excess synthesis and deposition of collagen in the skin and underlying connective tissues results in hardened cutaneous areas. Morphea has different clinical features according to the subtype and stage of evolution of the disease. There is currently no consensus on optimal interventions for morphea.
OBJECTIVES


To assess the effects of treatments for people with any form of morphea.
SEARCH METHODS


We searched the following databases up to July 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and five trial registers. We checked the reference lists of included studies for further references to relevant randomised controlled trials.
SELECTION CRITERIA


Randomised controlled trials of topical, intralesional, or systemic treatments (isolated or combined) in anyone who has been clinically diagnosed by a medical practitioner with any form of morphea. Eligible controls were placebo, no intervention, any other treatment, or different doses or duration of a treatment.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. The primary outcomes were global improvement of disease activity or damage assessed by a medical practitioner or by participants, and adverse effects. Secondary outcomes were improvement of disease activity and improvement of disease damage. We used GRADE to assess the quality of the evidence for each outcome.
MAIN RESULTS


We included 14 trials, with a total of 429 randomised participants, aged between 3 and 76 years. There were juvenile and adult participants; over half were female, and the majority had circumscribed morphea, followed by linear scleroderma. The settings of the studies (where described) included a dermatologic centre, a national laboratory centre, paediatric rheumatology and dermatology centres, and a university hospital or medical centre.The studies evaluated heterogenous therapies for different types of morphea, covering a wide range of comparisons. We were unable to conduct any meta-analyses. Seven studies investigated topical medications, two evaluated intralesional medications, and five investigated systemic medications. The study duration ranged from seven weeks to 15 months from baseline.We present here results for our primary outcomes for our four key comparisons. All of these results are based on low-quality evidence.The included studies were at high risk of performance, detection, attrition, and reporting bias.Global improvement of disease activity or damage after treatment may be higher with oral methotrexate (15 mg/m², maximum 20 mg, once a week, for 12 months or until disease flare) plus oral prednisone (1 mg/kg a day, maximum of 50 mg, in a single morning dose, for three months, and one month with gradually decreased dose until discontinuation) than with placebo plus oral prednisone in children and adolescents with active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed) (risk ratio (RR) 2.31, 95% confidence interval (CI) 1.20 to 4.45; number needed to treat for an additional beneficial outcome (NNTB) 3; 1 randomised controlled trial (RCT); 70 participants, all juvenile). This outcome was measured 12 months from the start of treatment or until flare of the disease. Data were not available separately for each morphea type. There may be little or no difference in the number of participants experiencing at least one adverse event with oral methotrexate (26/46) or placebo (11/24) (RR 1.23, 95% CI 0.75 to 2.04; 1 RCT; 70 participants assessed during the 12-month follow-up). Adverse events related to methotrexate included alopecia, nausea, headache, fatigue and hepatotoxicity, whilst adverse events related to prednisone (given in both groups) included weight gain (more than 5% of body weight) and striae rubrae.One three-armed RCT compared the following treatments: medium-dose (50 J/cm²) UVA-1; low-dose (20 J/cm²) UVA-1; and narrowband UVB phototherapy. There may be little or no difference between treatments in global improvement of disease activity or damage, as assessed through the modified skin score (where high values represent a worse outcome): medium-dose UVA-1 phototherapy versus low-dose UVA-1 group: MD 1.60, 95% CI -1.70 to 4.90 (44 participants); narrowband UVB phototherapy versus medium-dose UVA-1 group: MD -1.70, 95% CI -5.27 to 1.87 (35 participants); and narrowband UVB versus low-dose UVA-1 group: MD -0.10, 95% CI -2.49 to 2.29 (45 participants). This RCT included children and adults with active morphea (circumscribed morphea, linear scleroderma (with trunk/limb variant and head variant), generalised morphea, or mixed morphea), who received phototherapy five times a week, for eight weeks. Outcomes were measured at eight weeks from the start of treatment.Safety data, measured throughout treatment, from the same RCT (62 participants) showed that treatment with UVA-1 phototherapy may cause mild tanning compared to narrowband UVB: narrowband UVB versus medium-dose UVA-1: RR 0.03, 95% CI 0.00 to 0.42; 35 participants; narrowband UVB versus low-dose UVA-1: RR 0.03, 95% CI 0.00 to 0.41; 45 participants. However, there may be no difference in the number of participants reporting mild tanning when comparing medium and low dose UVA-1 phototherapy (RR 1.00, 95% CI 0.91 to 1.10; 44 participants). Transient erythema was reported in three participants with narrowband UVB and no participants in the low- or medium-dose UVA-1 groups.
AUTHORS' CONCLUSIONS


Compared to placebo plus oral prednisone, oral methotrexate plus oral prednisone may improve disease activity or damage in juvenile active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed), but there may be a slightly increased chance of experiencing at least one adverse event.When medium-dose UVA-1 (50 J/cm²), low-dose UVA-1 (20 J/cm²), and narrowband UVB were compared against each other in treating children and adults with active morphea (circumscribed morphea, linear scleroderma, generalised morphea and mixed morphea), there may be little or no difference between these treatments on global improvement of disease activity or damage. UVA-1 phototherapy may cause more mild tanning than narrowband UVB, but there may be no difference between medium- and low-dose UVA-1 phototherapy. These results are based on low-quality evidence.Limitations of data and analyses include risk of bias and imprecision (small number of participants or events and wide confidence intervals). We encourage multicentre RCTs to increase sample size and evaluate, with validated tools, different treatment responses according to the subtypes of morphea and age groups.",2019,"Compared to placebo plus oral prednisone, oral methotrexate plus oral prednisone may improve disease activity or damage in juvenile active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed), but there may be a slightly increased chance of experiencing at least one adverse event.","['14 trials, with a total of 429 randomised participants, aged between 3 and 76 years', 'people with any form of morphea', 'studies (where described) included a dermatologic centre, a national laboratory centre, paediatric rheumatology and dermatology centres, and a university hospital or medical centre', 'anyone who has been clinically diagnosed by a medical practitioner with any form of morphea', 'children and adults with active morphea (circumscribed morphea, linear scleroderma, generalised morphea and mixed morphea', 'children and adults with active morphea (circumscribed morphea, linear scleroderma (with trunk/limb variant and head variant), generalised morphea, or mixed morphea']","['phototherapy', 'oral methotrexate', 'UVA-1', 'UVA-1 phototherapy ', 'placebo', 'narrowband UVB: narrowband UVB versus medium-dose UVA-1', 'oral prednisone', 'methotrexate', 'placebo plus oral prednisone', 'UVA-1 phototherapy', 'placebo plus oral prednisone, oral methotrexate plus oral prednisone', 'narrowband UVB phototherapy']","['modified skin score', 'Transient erythema', 'global improvement of disease activity or damage assessed by a medical practitioner or by participants, and adverse effects', 'alopecia, nausea, headache, fatigue and hepatotoxicity, whilst adverse events', 'disease activity and improvement of disease damage', 'weight gain', 'global improvement of disease activity or damage', 'disease activity or damage']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1527383', 'cui_str': 'Morphea'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0263409', 'cui_str': 'Linear Scleroderma'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy (procedure)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner (occupation)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",70.0,0.405154,"Compared to placebo plus oral prednisone, oral methotrexate plus oral prednisone may improve disease activity or damage in juvenile active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed), but there may be a slightly increased chance of experiencing at least one adverse event.","[{'ForeName': 'Julia V de', 'Initials': 'JV', 'LastName': 'Albuquerque', 'Affiliation': 'Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Rua Borges Lagoa, 564 cj 63, São Paulo, São Paulo, Brazil, 04038-000.'}, {'ForeName': 'Brenda Ng', 'Initials': 'BN', 'LastName': 'Andriolo', 'Affiliation': ''}, {'ForeName': 'Monica Ra', 'Initials': 'MR', 'LastName': 'Vasconcellos', 'Affiliation': ''}, {'ForeName': 'Vinicius T', 'Initials': 'VT', 'LastName': 'Civile', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lyddiatt', 'Affiliation': ''}, {'ForeName': 'Virginia Fm', 'Initials': 'VF', 'LastName': 'Trevisani', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD005027.pub5']
882,31305874,Nabiximols for the Treatment of Cannabis Dependence: A Randomized Clinical Trial.,"Importance


There are no effective medications for treating dependence on cannabis.
Objective


To examine the safety and efficacy of nabiximols in the treatment of patients with cannabis dependence.
Design, Setting, and Participants


This parallel double-blind randomized clinical trial comparing nabiximols with placebo in a 12-week, multisite outpatient study recruited participants from February 3, 2016, to June 14, 2017, at 4 outpatient specialist alcohol and drug treatment services in New South Wales, Australia. Participants had cannabis dependence (as defined by the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision) and were seeking treatment, were nonresponsive to prior treatment attempts, were 18 to 64 years of age, had no other substance use disorder, had no severe medical or psychiatric conditions, were not pregnant, were not mandated by a court to undergo treatment, and provided informed consent. Results for primary efficacy measures and all secondary outcomes were obtained using a modified intention-to-treat data set.
Interventions


Participants received 12-week treatment involving weekly clinical reviews, structured counseling, and flexible medication doses-up to 32 sprays daily (tetrahydrocannabinol, 86.4 mg, and cannabidiol, 80 mg), dispensed weekly.
Main Outcomes and Measures


Primary outcome was self-reported number of days using illicit cannabis during the 12-week period. Other outcomes included alternate cannabis use parameters (periods of abstinence, withdrawal, cravings, and problems), safety parameters (adverse events and aberrant medication use), health status, other substance use, and treatment retention.
Results


A total of 128 participants (30 women and 98 men; mean [SD] age, 35.0 [10.9] years) were randomized and received at least 1 dose of study medication. Participants had used a mean (SD) of 2.3 (2.1) g of cannabis on a mean (SD) of 25.7 (4.5) days in the past 28 days. Treatment retention was comparable for the 2 groups (placebo, 30 of 67 participants [44.8%]; nabiximols, 30 of 61 participants [49.2%]), and both groups used similar mean (SD) doses (placebo, 18.5 [9.5] sprays daily; nabiximols, 17.6 [9.5] sprays daily, equivalent to a mean [SD] of 47.5 [25.7] mg of tetrahydrocannabinol and 44.0 [23.8] mg of cannabidiol). For the primary end point, the placebo group reported significantly more days using cannabis during the 12 weeks (mean [SD], 53.1 [33.0] days) than the nabiximols group (mean [SD], 35.0 [32.4] days; estimated difference, 18.6 days; 95% CI, 3.5-33.7 days; P = .02). Both groups showed comparable improvements in health status, with no substantial changes in other substance use. Medication was well tolerated with few adverse events.
Conclusions and Relevance


This study demonstrates that cannabinoid agonist treatment, in this case using nabiximols, in combination with psychosocial interventions is a safe approach for reducing cannabis use among individuals with cannabis dependence who are seeking treatment.
Trial Registration


anzctr.org.au Identifier: ACTRN12616000103460.",2019,"Treatment retention was comparable for the 2 groups (placebo, 30 of 67 participants [44.8%]; nabiximols, 30 of 61 participants [49.2%]), and both groups used similar mean (SD) doses (placebo, 18.5 [9.5] sprays daily; nabiximols, 17.6 [9.5] sprays daily, equivalent to a mean [SD] of 47.5 [25.7] mg of tetrahydrocannabinol and 44.0 [23.8] mg of cannabidiol).","['Cannabis Dependence', 'multisite outpatient study recruited participants from February 3, 2016, to June 14, 2017, at 4 outpatient specialist alcohol and drug treatment services in New South Wales, Australia', '128 participants (30 women and 98 men; mean [SD] age, 35.0 [10.9] years', 'patients with cannabis dependence', 'Participants had cannabis dependence (as defined by the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision) and were seeking treatment, were nonresponsive to prior treatment attempts, were 18 to 64 years of age, had no other substance use disorder, had no severe medical or psychiatric conditions, were not pregnant, were not mandated by a court to undergo treatment, and provided informed consent', 'Participants had used a mean (SD) of 2.3 (2.1) g of cannabis on a mean (SD) of 25.7 (4.5) days in the past 28 days', 'individuals with cannabis dependence who are seeking treatment']","['structured counseling, and flexible medication doses-up to 32 sprays daily (tetrahydrocannabinol, 86.4 mg, and cannabidiol, 80 mg), dispensed weekly', 'placebo', 'anzctr.org.au Identifier', 'psychosocial interventions']","['self-reported number of days using illicit cannabis', 'Treatment retention', 'safety and efficacy of nabiximols', 'modified intention-to-treat data set', 'alternate cannabis use parameters (periods of abstinence, withdrawal, cravings, and problems), safety parameters (adverse events and aberrant medication use), health status, other substance use, and treatment retention', 'health status']","[{'cui': 'C0006870', 'cui_str': 'Cannabis Dependence'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0936079', 'cui_str': 'Hemp Plant'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205444', 'cui_str': 'Tenth (qualifier value)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2347556', 'cui_str': 'tetrahydrocannabinol-cannabidiol combination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",128.0,0.280993,"Treatment retention was comparable for the 2 groups (placebo, 30 of 67 participants [44.8%]; nabiximols, 30 of 61 participants [49.2%]), and both groups used similar mean (SD) doses (placebo, 18.5 [9.5] sprays daily; nabiximols, 17.6 [9.5] sprays daily, equivalent to a mean [SD] of 47.5 [25.7] mg of tetrahydrocannabinol and 44.0 [23.8] mg of cannabidiol).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'Drug and Alcohol Services, Hunter New England Local Health District, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'National Drug and Alcohol Research Centre, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McGregor', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'School of Psychology, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gugusheff', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nghi', 'Initials': 'N', 'LastName': 'Phung', 'Affiliation': 'Drug Health, Western Sydney Local Health District, Parramatta, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Chan', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, Faculty of Medicine and Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Drug and Alcohol Services, Hunter New England Local Health District, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'Drug Health, Western Sydney Local Health District, Parramatta, New South Wales, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Luksza', 'Affiliation': 'Drug Health, Western Sydney Local Health District, Parramatta, New South Wales, Australia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Shanahan', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kevin', 'Affiliation': 'Drug and Alcohol Services, Hunter New England Local Health District, Newcastle, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Allsop', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.1993']
883,32108976,Improving Cancer Patients' Insurance Choices (I Can PIC): A Randomized Trial of a Personalized Health Insurance Decision Aid.,"BACKGROUND


Many cancer survivors struggle to choose a health insurance plan that meets their needs because of high costs, limited health insurance literacy, and lack of decision support. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial.
MATERIALS AND METHODS


Eligible individuals (18-64 years, diagnosed with cancer for ≤5 years, English-speaking, not Medicaid or Medicare eligible) were randomized to I Can PIC or an attention control health insurance worksheet. Primary outcomes included health insurance knowledge, decisional conflict, and decision self-efficacy after completing I Can PIC or the control. Secondary outcomes included knowledge, decisional conflict, decision self-efficacy, health insurance literacy, financial toxicity, and delayed care at a 3-6-month follow-up.
RESULTS


A total of 263 of 335 eligible participants (79%) consented and were randomized; 206 (73%) completed the initial survey (106 in I Can PIC; 100 in the control), and 180 (87%) completed a 3-6 month follow-up. After viewing I Can PIC or the control, health insurance knowledge and a health insurance literacy item assessing confidence understanding health insurance were higher in the I Can PIC group. At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed. There were no significant differences between groups in other outcomes. Results did not change when controlling for health literacy and employment. Both groups reported having limited health insurance options.
CONCLUSION


I Can PIC can improve cancer survivors' health insurance knowledge and confidence using health insurance. System-level interventions are needed to lower financial toxicity and help patients manage care costs.
IMPLICATIONS FOR PRACTICE


Inadequate health insurance compromises cancer treatment and impacts overall and cancer-specific mortality. Uninsured or underinsured survivors report fewer recommended cancer screenings and may delay or avoid needed follow-up cancer care because of costs. Even those with adequate insurance report difficulty managing care costs. Health insurance decision support and resources to help manage care costs are thus paramount to cancer survivors' health and care management. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial. I Can PIC provides health insurance information, supports patients through managing care costs, offers a list of financial and emotional support resources, and provides a personalized cost estimate of annual health care expenses across plan types.",2020,"At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed.","['A total of 263 of 335 eligible participants (79%) consented and were randomized; 206 (73%) completed the initial survey (106 in I Can PIC; 100 in the control), and 180 (87%) completed a 3-6 month follow-up', ""Cancer Patients' Insurance Choices (I Can PIC"", 'Eligible individuals (18-64\u2009years, diagnosed with cancer for ≤5\u2009years, English-speaking, not Medicaid or Medicare eligible']",['I Can PIC or an attention control health insurance worksheet'],"['health literacy and employment', 'health insurance knowledge, decisional conflict, and decision self-efficacy after completing I Can PIC or the control', 'knowledge, decisional conflict, decision self-efficacy, health insurance literacy, financial toxicity, and delayed care at a 3-6-month follow-up']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]","[{'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",335.0,0.111716,"At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed.","[{'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Grant', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Nerissa P', 'Initials': 'NP', 'LastName': 'George', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Barker', 'Affiliation': 'Brown School and Center for Health Economics and Policy, Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Kuroki', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'McBride', 'Affiliation': 'Brown School and Center for Health Economics and Policy, Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Goodwin', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0703']
884,31958177,Worked examples for teaching electrocardiogram interpretation: Salient or discriminatory features?,"CONTEXT


Cognitive load theory states that one way to optimise learning is to decrease extraneous cognitive load, defined as information not relevant to task completion. Worked examples, which show the learner the logic behind the solving of a problem, can decrease extraneous load. However, there is little research to guide the optimal formatting of worked examples.
METHODS


In a crossover design, first-year medical students were randomised to worked examples of bradycardias with salient features first and tachycardias with discriminatory features second (n = 33) or worked examples of bradycardias with discriminatory features first and tachycardias with salient features second (n = 32). After each learning phase, participants completed a testing phase. Diagnostic accuracy and reported cognitive load were compared between the two worked example formats, as well as with data for a group of historical controls, consisting of medical students interpreting electrocardiogram rhythms without worked examples. Each module concluded with a questionnaire in which the learner was asked to rate his or her perceptions of the difficulty of the core content, the clarity with which the information was presented, and perceived learning.
RESULTS


Worked examples highlighting salient and discriminatory features were associated with similar levels of diagnostic accuracy (56% and 60%, respectively; P = .32). Both worked example conditions were associated with higher diagnostic accuracy than was found in historical controls (P < .0001). There was no difference in the extraneous load experienced between worked examples highlighting salient features and those highlighting discriminatory features (12.5 ± 6.1 and 11.9 ± 6.1, respectively; P = .52). Participants reported greater intrinsic load in the worked examples highlighting salient rather than discriminatory features (17.1 ± 4.9 and 15.5 ± 4.6, respectively; P = .01).
CONCLUSIONS


Discriminatory feature-based worked examples were associated with less intrinsic cognitive load, but this did not translate into any meaningful difference in diagnostic performance. Instruction with worked examples improved diagnostic performance regardless of whether salient or discriminatory features were highlighted.",2020,"RESULTS


Worked examples highlighting salient and discriminating features were associated with similar diagnostic accuracy (56 vs 60%, p = 0.32).",[],[],"['intrinsic load', 'diagnostic accuracy']",[],[],"[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",,0.044689,"RESULTS


Worked examples highlighting salient and discriminating features were associated with similar diagnostic accuracy (56 vs 60%, p = 0.32).","[{'ForeName': 'Terence Huy', 'Initials': 'TH', 'LastName': 'Thach', 'Affiliation': 'Division of Emergency Medicine, Postgraduate medical education, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blissett', 'Affiliation': 'Division of Cardiology, Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sibbald', 'Affiliation': 'Division of Cardiology, Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}]",Medical education,['10.1111/medu.14066']
885,31317180,Subxiphoid versus intercostal uniportal video-assisted thoracoscopic surgery for bilateral lung resections: a single-institution experience.,"OBJECTIVES


Subxiphoid uniportal video-assisted thoracoscopic surgery (SUVATS) is a technically difficult and challenging operation that can help decrease pain around the incision after traditional intercostal uniportal video-assisted thoracoscopic surgery (IUVATS), and can also treat bilateral lesions through the same incision. We aimed to compare perioperative outcomes and pain scores after SUVATS and IUVATS in patients receiving synchronous treatment of bilateral lung lesions.
METHODS


Patients who received SUVATS and IUVATS bilateral lung resections from September 2014 to February 2018 were analysed. Ultimately a total of 381 cases were analysed after using one-to-one propensity score matching to match baseline characteristics between the 2 groups.
RESULTS


The 381 patients included 56 with SUVATS and 325 with IUVATS. After matching, 54 SUVATS and 54 IUVATS cases were analysed. The 2 groups had similar preoperative factors and did not differ with respect to duration of chest tube placement, length of stay in hospital and incidence of postoperative complications. SUVATS was associated with a significantly longer operative time (212.3 vs 154.6 min, P < 0.001) and more blood loss (190.9 vs 72.7 ml, P < 0.001), lower pain score on the first day after operation (2.6 vs 3.0, P = 0.03) and before discharge (0.8 vs 1.4, P < 0.001). Furthermore, less patients in group SUVATS requested for additional analgesic therapy (P = 0.03).
CONCLUSIONS


Compared with IUVATS, despite the longer operative time and greater blood loss, SUVATS for bilateral lung lesions is a safe surgical procedure associated with significantly less postoperative pain and a similar incidence of postoperative complications in selected patients.",2020,"The 2 groups had similar preoperative factors and did not differ with respect to duration of chest tube placement, length of stay in hospital and incidence of postoperative complications.","['Patients who received SUVATS and IUVATS bilateral lung resections from September 2014 to February 2018 were analysed', 'patients receiving synchronous treatment of bilateral lung lesions', '381 patients included 56 with SUVATS and 325 with IUVATS', 'bilateral lung resections']","['Subxiphoid uniportal video-assisted thoracoscopic surgery (SUVATS', 'SUVATS and IUVATS', 'Subxiphoid versus intercostal uniportal video-assisted thoracoscopic surgery']","['lower pain score', 'blood loss', 'postoperative pain', 'duration of chest tube placement, length of stay in hospital and incidence of postoperative complications', 'perioperative outcomes and pain scores', 'longer operative time', 'postoperative complications', 'operative time and greater blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}]","[{'cui': 'C4304660', 'cui_str': 'Uniportal video assisted thoracoscopic surgery (procedure)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",2018.0,0.0667574,"The 2 groups had similar preoperative factors and did not differ with respect to duration of chest tube placement, length of stay in hospital and incidence of postoperative complications.","[{'ForeName': 'Haomin', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Al Sawalhi', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Gening', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Deping', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz206']
886,30010175,RE: The Evaluation of the Result of Warm Normal Saline Irrigation in Ureteral Endoscopic Surgeries: A Randomized Clinical Trial.,,2018,,['Ureteral Endoscopic Surgeries'],['RE'],[],"[{'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}]",[],[],,0.175794,,"[{'ForeName': 'Amir Hosseini', 'Initials': 'AH', 'LastName': 'Kashi', 'Affiliation': 'Hasheminejad Kidney Center (HKC), Iran University of Medical Sciences, Tehran, Iran. ahkashi@gmail.com.'}]",Urology journal,['10.22037/uj.v15i4.4682']
887,26675661,Pilot feasibility and safety study examining the effect of medium chain triglyceride supplementation in subjects with mild cognitive impairment: A randomized controlled trial.,"BACKGROUND


Impaired brain glucose metabolism appears to be a potential pathogenic feature of mild cognitive impairment (MCI). This study examined the potential for increasing circulating ketone bodies through medium chain triglyceride (MCT) supplementation, as a means to beneficially modulate brain homeostasis in subjects with MCI.
METHODS


Six participants with MCI were enrolled in a randomized placebo-controlled trial. Participants received 56 g/day of either medium chain triglycerides (MCTs) or placebo for 24 weeks. Serum β-hydroxybutyrate concentrations, apolipoprotein-E4 status, and cognitive assessments were carried out. Due to the small number of participants only the raw scores were examined.
RESULTS


Intake of MCT oil increased serum ketone bodies and improved memory, while intake of placebo did not show improvement in any of the cognitive measures tested.
CONCLUSIONS


Consumption of 56 g/day of MCTs for 24 weeks increases serum ketone concentrations and appears to be a candidate for larger randomized control trials in the future that quantify the modulation of cognitive function through supplementation with ketone precursors, in patients with MCI.",2015,"RESULTS


Intake of MCT oil increased serum ketone bodies and improved memory, while intake of placebo did not show improvement in any of the cognitive measures tested.
","['subjects with MCI', 'patients with MCI', 'subjects with mild cognitive impairment', 'Six participants with MCI']","['medium chain triglycerides (MCTs) or placebo', 'placebo', 'MCT oil', 'medium chain triglyceride (MCT) supplementation', 'medium chain triglyceride supplementation']","['Serum β-hydroxybutyrate concentrations, apolipoprotein-E4 status, and cognitive assessments', 'serum ketone concentrations', 'serum ketone bodies and improved memory']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0556090', 'cui_str': 'Medium chain triglyceride supplementation (product)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0103843', 'cui_str': 'apolipoprotein E4 (Philadelphia)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1287282', 'cui_str': 'Finding of ketone concentration, dipstick (finding)'}, {'cui': 'C0202110', 'cui_str': 'Ketone bodies measurement, quantitative (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",6.0,0.247524,"RESULTS


Intake of MCT oil increased serum ketone bodies and improved memory, while intake of placebo did not show improvement in any of the cognitive measures tested.
","[{'ForeName': 'Candida J', 'Initials': 'CJ', 'LastName': 'Rebello', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, United States ; School of Nutrition and Food Sciences, Louisiana State University, Baton Rouge, United States.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Keller', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, United States.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Liu', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, United States.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, United States.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, United States.'}]",BBA clinical,['10.1016/j.bbacli.2015.01.001']
888,31308360,Development of a delayed-release nutrient for appetite control in adults with obesity and type 2 diabetes and initial clinical testing in a single dose randomized controlled trial.,"BACKGROUND AND OBJECTIVES


Delivery of nutrients directly to the small intestine, either via enteral feeding tube or by gastric bypass surgery, is associated with increased levels of appetite-suppressing and glucoregulatory hormones, including GLP-1, and reduced appetite. Achieving these changes non-invasively using formulated foods may be of therapeutic benefit in individuals with obesity and related comorbidities. The aim of this pilot study was to determine the effect of a single dose of a novel delayed-release nutrient (DRN) on glucose, GLP-1, c-peptide, insulin, and appetite in adults with obesity and type 2 diabetes.
SUBJECTS AND METHODS


We formulated an all-natural, generally recognized as safe ('GRAS"") DRN and conducted a randomized prospective crossover trial. Nineteen adults with obesity and type 2 diabetes underwent paired 3-h meal tolerance tests (MTT) in randomized order 1-4 weeks apart. Subjects ingested a single dose of DRN and the same nutrients as unformulated powders (UN).
RESULTS


For DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed. While Tmax for GLP-1 was also significantly delayed following DRN compared with UN (45 min later; p = 0.26), Cmax did not differ significantly. GLP-1 rose significantly during the last 90 min of the 3-h MTT (β 1  = 0.16 pg/mL/min, p = 0.025), while following UN it decreased (β 1  = -0.21 pg/mL/min, p = 0.0026) (p difference = 0.0003). There were minimal differences in seven measures of appetite and adverse symptoms between DRN and UN.
CONCLUSIONS


We conclude that nutrient can be formulated using all-natural ingredients to induce a delayed rise in GLP-1. Further testing is needed to determine the amount and site of nutrient release, when maximum GLP-1 levels occur, and if modification of the formulation specifications and dose are associated with appetite and glucose control.",2019,"RESULTS


For DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed.","['Nineteen adults with obesity and type 2 diabetes underwent', 'individuals with obesity and related comorbidities', 'adults with obesity and type 2 diabetes']","['novel delayed-release nutrient (DRN', 'paired 3-h meal tolerance tests (MTT']","['GLP-1', 'appetite and adverse symptoms', 'time of maximal concentration (Tmax', 'maximal concentration (Cmax', 'glucose, GLP-1, c-peptide, insulin, and appetite']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C4544674', 'cui_str': 'Delayed-release'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0647210', 'cui_str': 'MTTS'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",19.0,0.0759147,"RESULTS


For DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA. beale@usc.edu.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'SC CTSI, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yassine', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Azen', 'Affiliation': 'SC CTSI, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Christopher', 'Affiliation': 'CaliVive Inc., San Mateo, CA, 94402, USA.'}]",Nutrition & diabetes,['10.1038/s41387-019-0088-7']
889,32125434,Meningococcal and pneumococcal carriage in Hajj pilgrims: findings of a randomized controlled trial.,"BACKGROUND


Intense congestion during the Hajj pilgrimage amplifies the risk of meningococcal carriage and disease, and there have been many meningococcal outbreaks reported amongst pilgrims. Thus, a strict vaccination policy is enforced by the host country and either polysaccharide or conjugate quadrivalent meningococcal vaccines are mandatory. However, unlike conjugate vaccines, the polysaccharide vaccine is not thought to reduce pharyngeal carriage of meningococci.
METHODS


A single-blinded, randomized, controlled trial amongst pilgrims from Saudi Arabia and Australia during the Hajj seasons of 2016-2017 was conducted to compare MenACWY-Conjugate vaccine with MenACWY-Polysaccharide vaccine, to determine if the conjugate vaccine is more effective in reducing asymptomatic carriage of meningococci, and whether the effect may be long-standing. Oropharyngeal swabs were obtained pre-, immediately post- and 6-11 months following completion of Hajj and tested for the presence of meningococci.
RESULTS


Amongst 2000 individuals approached, only 1146 participants aged 18-91 (mean 37.6) years agreed to participate and were randomized to receive either the polysaccharide (n = 561) or the conjugate (n = 561) vaccine, 60.8% were male, and 93.5% were from Saudi Arabia. Amongst oropharyngeal swabs obtained before Hajj, only two (0.2%) tested positive for Neisseria meningitidis. Similarly, meningococci were identified in only one sample at each of the post-Hajj and late follow-up visits. None of the carriage isolates were amongst the serogroups covered by the vaccines. A post hoc analysis of the third swabs revealed that 22.4% of all participants (50/223) were positive for Streptococcus pneumoniae nucleic acid.
CONCLUSION


The low overall carriage rate of meningococci found amongst Hajj pilgrims in 2016 and 2017 demonstrates a successful vaccination policy, but neither supports nor refutes the superiority of meningococcal conjugate ACWY vaccine over the polysaccharide vaccine against carriage. Although an association could not be established in this study, molecular epidemiology would help to establish the role of Hajj in facilitating transmission of pneumococci and inform vaccination policy.",2020,"Among oropharyngeal swabs obtained before Hajj, only two (0.2%) tested positive for Neisseria meningitidis.","['2000 individuals approached, only 1146 participants aged 18-91 (mean 37.6) years agreed to participate', 'pilgrims from Saudi Arabia and Australia during the Hajj seasons of 2016-2017', 'Hajj pilgrims']","['vaccine with MenACWY-Polysaccharide vaccine', 'polysaccharide (n\u2009=\u2009561) or conjugate (n\u2009=\u2009561) vaccine']",[],"[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]",[],,0.259203,"Among oropharyngeal swabs obtained before Hajj, only two (0.2%) tested positive for Neisseria meningitidis.","[{'ForeName': 'Al-Mamoon', 'Initials': 'AM', 'LastName': 'Badahdah', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah 22252, Saudi Arabia.'}, {'ForeName': 'Marwan A', 'Initials': 'MA', 'LastName': 'Bakarman', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah 22252, Saudi Arabia.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Khatami', 'Affiliation': ""The Discipline of Child and Adolescent Health, The Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Tashani', 'Affiliation': ""The Discipline of Child and Adolescent Health, The Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia.""}, {'ForeName': 'Osamah', 'Initials': 'O', 'LastName': 'Barasheed', 'Affiliation': 'The Executive Administration of Research and Innovation, King Abdullah Medical City in Holy Capital (KAMC-HC), Makkah 24246, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alfelali', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah 22252, Saudi Arabia.'}, {'ForeName': 'Mohammad I', 'Initials': 'MI', 'LastName': 'Azeem', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW 2145, Australia.""}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Bokhary', 'Affiliation': 'Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soltan', 'Affiliation': 'Microbiology department, Al Borg Medical Laboratories, Jeddah 21573, Saudi Arabia.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Lahra', 'Affiliation': 'The World Health Organisation Collaborating Centre for STI and AMR, and Neisseria Reference Laboratory, New South Wales Health Pathology, Microbiology, Prince of Wales Hospital, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Neisha', 'Initials': 'N', 'LastName': 'Jeoffreys', 'Affiliation': 'New South Wales Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital and University of Sydney, Westmead NSW 2145, Australia.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Kok', 'Affiliation': 'New South Wales Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital and University of Sydney, Westmead NSW 2145, Australia.'}, {'ForeName': 'Dominic E', 'Initials': 'DE', 'LastName': 'Dwyer', 'Affiliation': 'New South Wales Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital and University of Sydney, Westmead NSW 2145, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Booy', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW 2145, Australia.""}, {'ForeName': 'Harunor', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW 2145, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of travel medicine,['10.1093/jtm/taaa032']
890,31297799,Divergent Thinking Promotes Deductive Reasoning in Preschoolers.,"This study explored the hypothesis that preschoolers' deductive reasoning would be improved by encouraging use of divergent thinking (DT). Children of 4-5 years of age (n = 120) were randomly given DT or neutral control exercises before deductive reasoning problems. To allow a stronger test of the hypothesis, half of the children receiving the DT exercises were given explicit examples, which have been shown to reduce ideational originality. Results indicate that, as predicted, DT exercises without examples significantly improved rates of deductive responding, compared to exercises with examples and the control condition. These findings indicate that DT is a key component in the early beginnings of deductive reasoning. Some educational implications are discussed.",2020,"Results indicate that, as predicted, DT exercises without examples significantly improved rates of deductive responding, compared to exercises with examples and the control condition.","['Children of 4-5\xa0years of age (n\xa0=\xa0120', 'Preschoolers']","['Divergent Thinking Promotes Deductive Reasoning', 'DT or neutral control exercises']",['rates of deductive responding'],"[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.0170416,"Results indicate that, as predicted, DT exercises without examples significantly improved rates of deductive responding, compared to exercises with examples and the control condition.","[{'ForeName': 'Pier-Luc', 'Initials': 'PL', 'LastName': 'de Chantal', 'Affiliation': 'Université du Québec à Montréal.'}, {'ForeName': 'Émilie', 'Initials': 'É', 'LastName': 'Gagnon-St-Pierre', 'Affiliation': 'Université du Québec à Montréal.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Markovits', 'Affiliation': 'Université du Québec à Montréal.'}]",Child development,['10.1111/cdev.13278']
891,31023352,Protocol for a randomised controlled feasibility study examining the efficacy of brief cognitive therapy for the Treatment of Anxiety Disorders in Adolescents (TAD-A).,"BACKGROUND


Anxiety disorders affect a quarter of the population during their lifetime, and typically emerge in childhood or adolescence. Anxiety disorders disrupt young people's social, emotional and academic development and in the absence of treatment, often follow a chronic course. Although effective treatments, such as Cognitive Behaviour Therapy (CBT), exist, only a small proportion of adolescents with anxiety disorders who need treatment receive them. Barriers to treatment provision include the fact that CBT typically requires 14-16 sessions by a highly qualified therapist and services are stretched - resulting in lengthy waiting lists and limited access to treatment. This highlights the importance of developing new ways of providing effective treatments for adolescent anxiety disorders. This study aims to assess the feasibility of a future, large-scale trial. This will give a clear indication of the likely success of running a randomised controlled trial to compare a new, brief cognitive therapy treatment to an existing CBT group therapy for adolescents with anxiety disorders.
METHODS/DESIGN


The study will examine whether a definitive trial can be conducted on the basis of a feasibility RCT using a number of well-defined criteria. The feasibility RCT is a single-centre, randomised control trial. Forty-eight Young people (age 11-17.5 years) attending a university research clinic, who meet the diagnostic criteria for a DSM-5 anxiety disorder, will be randomly allocated to receive either (1) Adolescent Cognitive Therapy for Anxiety (ACTA), which involves six 60-90-min sessions and a booster session or (2) group CBT, which involves eight 2-h sessions and a booster session. As part of the feasibility indicators, patient outcomes, expectations and experiences, as well as health economic factors, will be assessed before, at the end of treatment and at a 3-month follow-up.
DISCUSSION


The successful delivery of a future, definitive trial has the potential to bring direct benefits to young people and their families, adolescent mental health service providers, as well as benefits to adult mental health services and society more broadly by disrupting the negative trajectory commonly associated with adolescent anxiety disorders.
TRIAL REGISTRATION


ISRCTN, ID: ISRCTN86123204 . Retrospectively registered on 23 November 2017.",2019,"The successful delivery of a future, definitive trial has the potential to bring direct benefits to young people and their families, adolescent mental health service providers, as well as benefits to adult mental health services and society more broadly by disrupting the negative trajectory commonly associated with adolescent anxiety disorders.
","['adolescent anxiety disorders', 'young people and their families, adolescent mental health service providers', 'Anxiety Disorders in Adolescents (TAD-A', 'adolescents with anxiety disorders', 'Retrospectively registered on 23 November 2017', 'Forty-eight Young people (age 11-17.5\u2009years) attending a university research clinic, who meet the diagnostic criteria for a DSM-5 anxiety disorder']","['Cognitive Behaviour Therapy (CBT', 'Adolescent Cognitive Therapy for Anxiety (ACTA', 'CBT group therapy', 'cognitive therapy', 'ID']",['Anxiety disorders'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]",48.0,0.0391607,"The successful delivery of a future, definitive trial has the potential to bring direct benefits to young people and their families, adolescent mental health service providers, as well as benefits to adult mental health services and society more broadly by disrupting the negative trajectory commonly associated with adolescent anxiety disorders.
","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Harry Pitt Building, Earley Gate, Reading, RG6 6AL, UK.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Waite', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Harry Pitt Building, Earley Gate, Reading, RG6 6AL, UK. p.l.waite@reading.ac.uk.'}, {'ForeName': 'Brynjar', 'Initials': 'B', 'LastName': 'Halldorsson', 'Affiliation': 'Departments of Experimental Psychology and Psychiatry, Anna, Watts Building, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Percy', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Harry Pitt Building, Earley Gate, Reading, RG6 6AL, UK.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Violato', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Creswell', 'Affiliation': 'Departments of Experimental Psychology and Psychiatry, Anna, Watts Building, Oxford, OX2 6GG, UK.'}]",Trials,['10.1186/s13063-019-3295-6']
892,31329221,Association Between Stress Testing-Induced Myocardial Ischemia and Clinical Events in Patients With Multivessel Coronary Artery Disease.,"Importance


The long-term prognostic implications of myocardial ischemia documented during stress testing in patients with multivessel coronary artery disease (CAD) are unclear.
Objective


To assess whether documented stress testing-induced myocardial ischemia is associated with major adverse cardiovascular events or ventricular function changes in patients with stable multivessel CAD.
Design, Setting, and Participants


A prospective cohort study was conducted using data from a single-center randomized clinical trial (Medicine, Angioplasty, or Surgery Study [MASS] II) to examine the association of myocardial ischemia documented during stress testing at baseline with cardiovascular events and ventricular function changes during follow-up. Participants were previously randomized (May 1, 1995, to May 31, 2000) to medical therapy, percutaneous coronary intervention with bare metal stents, or coronary artery bypass grafting. Event-free survival was estimated by the Kaplan-Meier method, and multivariable Cox regression models were calculated to assess the association between ischemia and the primary composite end point. The vital status was determined on February 28, 2011. Data were analyzed from February 1, 2016, to April 1, 2017.
Main Outcomes and Measures


Cardiovascular events (overall mortality, myocardial infarction, and revascularization for refractory angina) were tracked from the time of randomization to the end of the 10-year follow-up (mean [SD] duration, 11.4 [4.3] years). Myocardial ischemia was assessed at baseline and at 1-year intervals by exercise stress testing, and ventricular function (left ventricular ejection fraction) was assessed by echocardiography at baseline and after 10 years. Patients with documented ischemia were compared with those without ischemia regarding the outcomes and changes in ventricular function.
Results


Of 611 participants, 535 underwent exercise stress testing at baseline: 270 with documented ischemia and 265 without. Of these 535 patients, 373 (69.7%) were men, and the mean (SD) age for the entire cohort was 59.7 (9.2) years. No association was found between the presence of ischemia at baseline and survival free of combined cardiovascular events (hazard ratio, 1.00; 95% CI, 0.80-1.27; P = .95) after multivariable adjustment that included CAD initial randomized treatments. In addition, among 320 patients who underwent echocardiographic evaluation, the slight decline in left ventricular ejection fraction after 10 years was similar in both groups (median [SD] difference, -4.9% [18.7%] vs -6.6% [20.0%], respectively, for groups with and without ischemia; P = .97).
Conclusions and Relevance


In this study, regardless of the therapeutic strategy applied, the presence of documented myocardial ischemia did not appear to be associated with an increased occurrence of major adverse cardiovascular events or changes in ventricular function in patients with multivessel CAD during a long-term follow-up.",2019,"No association was found between the presence of ischemia at baseline and survival free of combined cardiovascular events (hazard ratio, 1.00; 95% CI, 0.80-1.27; P = .95) after multivariable adjustment that included CAD initial randomized treatments.","['patients with multivessel coronary artery disease (CAD', '535 patients, 373 (69.7%) were men, and the mean (SD) age for the entire cohort was 59.7 (9.2) years', 'Patients With Multivessel Coronary Artery Disease', 'patients with multivessel CAD', '611 participants, 535 underwent exercise stress testing at baseline: 270 with documented ischemia and 265 without', 'patients with stable multivessel CAD']","['medical therapy, percutaneous coronary intervention with bare metal stents, or coronary artery bypass grafting']","['Event-free survival', 'Myocardial ischemia', 'left ventricular ejection fraction', 'Measures\n\n\nCardiovascular events (overall mortality, myocardial infarction, and revascularization for refractory angina', 'ventricular function', 'ventricular function (left ventricular ejection fraction', 'presence of ischemia at baseline and survival free of combined cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0430120', 'cui_str': 'Exercise stress test - endocrine (procedure)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",611.0,0.0400239,"No association was found between the presence of ischemia at baseline and survival free of combined cardiovascular events (hazard ratio, 1.00; 95% CI, 0.80-1.27; P = .95) after multivariable adjustment that included CAD initial randomized treatments.","[{'ForeName': 'Cibele Larrosa', 'Initials': 'CL', 'LastName': 'Garzillo', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Whady', 'Initials': 'W', 'LastName': 'Hueb', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gersh', 'Affiliation': 'Department of Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Paulo Cury', 'Initials': 'PC', 'LastName': 'Rezende', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Gomes', 'Initials': 'EG', 'LastName': 'Lima', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Desiderio', 'Initials': 'D', 'LastName': 'Favarato', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Antônio', 'Initials': 'JA', 'LastName': 'Franchini Ramires', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.2227']
893,31314045,Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated.
Objective


To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial.
Design, Setting, and Participants


The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015.
Interventions


According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred.
Main Outcomes and Measures


The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups.
Results


Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25).
Conclusions and Relevance


The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.
Trial Registration


ClinicalTrials.gov identifier: NCT02053038.",2019,"The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.
","['patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial', 'total trial population (2492 patients), 758 patients (30.4%) had diabetes', '2492 patients in a 1:1 ratio to undergo either', 'Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465', 'Patients With or Without Type 2 Diabetes', 'Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery', 'patients with type 2 diabetes', 'patients with diabetes']","['iFR-guided or FFR-guided treatment', 'iFR-guided or FFR-guided coronary revascularization', 'iFR-guided and FFR-guided treatment']","['rate of deferral of revascularization', 'iFR guidance', 'rate of MACE', 'fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR', 'MACE rates', 'major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2492.0,0.0609224,"The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Seoul National University Hospital and Institute on Aging, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Hakim-Moulay', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, University College London, London, England.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Inje University Ilsan Paik Hospital, Daehwa-Dong, South Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Ulsan Hospital, Ulsan, South Korea and Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Iqbal S', 'Initials': 'IS', 'LastName': 'Malik', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Sukhjinder S', 'Initials': 'SS', 'LastName': 'Nijjer', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Mejía-Rentería', 'Affiliation': 'Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Alegria-Barrero', 'Affiliation': 'Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Altman', 'Affiliation': 'Colorado Heart and Vascular, Lakewood, Colorado.'}, {'ForeName': 'Sérgio B', 'Initials': 'SB', 'LastName': 'Baptista', 'Affiliation': 'Hospital Prof Doutor Fernando Fonseca, Amadora, Portugal.'}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Bojara', 'Affiliation': 'Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Pedro Canas', 'Initials': 'PC', 'LastName': 'Silva', 'Affiliation': 'Hospital Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Mario', 'Affiliation': 'Royal Brompton Hospital, Imperial College London, London, England.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Pauls Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Gerber', 'Affiliation': 'Conquest Hospital, St Leonards-on-Sea, England.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Going', 'Affiliation': 'Sana Klinikum Lichtenberg, Lichtenberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Härle', 'Affiliation': 'Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Farrel', 'Initials': 'F', 'LastName': 'Hellig', 'Affiliation': 'Sunninghill Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Indolfi', 'Affiliation': 'University Magna Graecia, Catanzaro, Italy.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Jeremias', 'Affiliation': 'Stony Brook University Medical Center, New York, New York.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Kharbanda', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, England.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Khashaba', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yuetsu', 'Initials': 'Y', 'LastName': 'Kikuta', 'Affiliation': 'Fukuyama Cardiovascular Hospital, Fukuyama, Japan.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krackhardt', 'Affiliation': 'Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lehman', 'Affiliation': 'Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Martijin', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Niccoli', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'AMC Heart Center, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Flavo', 'Initials': 'F', 'LastName': 'Ribichini', 'Affiliation': 'University Hospital Verona, Verona, Italy.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Samady', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sapontis', 'Affiliation': 'Monash Heart, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Arnold H', 'Initials': 'AH', 'LastName': 'Seto', 'Affiliation': 'Veterans Affairs Long Beach Healthcare System, Long Beach, California.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sezer', 'Affiliation': 'Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Royal Devon and Exeter Hospital, Exeter, England.'}, {'ForeName': 'Jasvindar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takashima', 'Affiliation': 'Aichi Medical University Hospital, Aichi, Japan.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, England.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, England.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Institut Coeur Poumon, Lille University Hospital, Lille, France.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vinhas', 'Affiliation': 'Hospital Garcia de Horta, Lisbon, Portugal.'}, {'ForeName': 'Christiaan J', 'Initials': 'CJ', 'LastName': 'Vrints', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Walters', 'Affiliation': 'Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Fukuoka Sannou Hospital, Fukuoka, Japan.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Samuels', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Buller', 'Affiliation': 'St Michaels Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Serruys', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2298']
894,31314143,Genetic testing for prevention of severe drug-induced skin rash.,"BACKGROUND


Drug-induced skin reactions present with a range of clinical symptoms, from mild maculopapular skin rashes to potentially fatal blistering skin rashes - such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) - which may result in death. Milder reactions may be troublesome and lead to low drug compliance. The pathogenesis of these drug reactions is not yet fully understood; however, there is evidence that pretreatment genetic testing may help to predict and prevent these reactions in some cases.
OBJECTIVES


To assess the effects of prospective pharmacogenetic screening to reduce drug-associated skin reactions in a patient population.
SEARCH METHODS


We searched the following databases up to July 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials registers, and checked the reference lists of included studies and relevant reviews for further references to relevant randomised controlled trials (RCTs).
SELECTION CRITERIA


We included RCTs of participants who had prospective pharmacogenetic screening to determine genetic variants associated with hypersensitivity reactions, compared with those who did not have prospective pharmacogenetic screening. We included participants in any setting, who were of any age, gender, and ethnicity, who had been prescribed drugs known to cause delayed type hypersensitivity reactions.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. To assess studies for inclusion, two review authors independently screened all of the titles and abstracts of publications identified by the searches. Because there was only one included study, many of the planned data analyses were not applicable to the review. We used GRADE to assess the quality of the included study.The review's primary outcomes were the incidence of severe skin rashes with systemic symptoms (such as fever and multiple organ involvement), and long-term effects (such as scarring of eyelids or lung tissue). Secondary outcomes were hospitalisation for drug-induced skin reactions, blistering skin reactions (such as SJS, hypersensitivity (HSS) syndrome), and death.
MAIN RESULTS


One study, which was a randomised, double-blind, controlled, multicentre trial, fulfilled our inclusion criteria. The trial included 1956 adult participants (74% men, with a mean age of 42 years) across 265 centres (medical centres, hospitals, outpatient clinics) in 19 countries around the world who were infected with HIV-type 1 and who had not received abacavir previously. The participants, who had a clinical need for treatment with an antiretroviral-drug regimen containing abacavir, were randomly assigned to undergo prospective human leukocyte antigen (HLA) Class I, locus B, allele 57:01 (HLA-B*57:01) screening (prospective-screening group) before this treatment, or to undergo a standard-care approach of abacavir use without prospective HLA-B*57:01 screening (control group). Participants who tested positive for HLA-B*57:01 were not given abacavir; instead, they received antiretroviral therapy that did not include abacavir. The control group did have retrospective HLA-B*57:01 pharmacogenetic testing. The trial duration was six months. Each participant was observed for six weeks. Assessments were performed at the time of study entry, at baseline (day one of abacavir treatment), and at weeks one, two and six. This study was funded by the manufacturer of abacavir, GlaxoSmithKline.The study did not assess any of our primary outcomes, and it measured none of our secondary outcomes in isolation. However, it did assess an outcome of (characteristically severe) hypersensitivity reaction which included (but was not limited to) our secondary outcomes of HSS and SJS/TEN.The study demonstrated that prospective HLA-B*57:01 screening probably reduces the incidence of hypersensitivity reaction to abacavir. The incidence of clinically diagnosed HSS reaction to abacavir was lower in the screening arm (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.28 to 0.67; 1650 participants; moderate-quality evidence), as was immunologically confirmed HSS reaction (RR 0.02, 95% 0.00 to 0.37; 1644 participants; moderate-quality evidence). A positive result from an epicutaneous patch test performed six to ten weeks after clinical diagnosis provided immunological confirmation.Overall, the study demonstrates a low risk of bias across five out of seven domains. There was a high risk of detection bias because hypersensitivity reactions were diagnosed by the principal investigator at the recruitment site without the use of predefined clinical criteria. Although there was also high risk of attrition bias due to excluding participants with incomplete follow-up from analyses, the authors did undertake a series of sensitivity analyses based on the intention-to-treat population, which demonstrated consistent results with the primary analysis. We rated the study quality as moderate-quality using GRADE criteria.
AUTHORS' CONCLUSIONS


Prospective screening for HLA-B*57:01 probably reduces severe hypersensitivity skin reactions to abacavir in patients positive for HIV-type 1. However, these results are only based on one study, which was at high risk of attrition and detection bias.Our primary outcomes (incidence of severe skin rashes with systemic symptoms, and long-term effects) were not assessed by the trial, and only one of the review's secondary outcomes was measured (hypersensitivity reaction); thus, we found no evidence relating to hospitalisation, death, or long-term conditions resulting from drug injury.We found no eligible evidence on genetic testing for severe drug-induced skin rash in relation to different drugs and classes of drugs. Further clinical trials based on other drugs, and in different patient populations, would be useful for advising policy changes for improving the prevention of adverse skin reactions to drug treatments.",2019,"AUTHORS' CONCLUSIONS


Prospective screening for HLA-B*57:01 probably reduces severe hypersensitivity skin reactions to abacavir in patients positive for HIV-type 1.","['participants, who had a clinical need for treatment with an antiretroviral-drug regimen containing', 'patient population', 'participants who had prospective pharmacogenetic screening to determine genetic variants associated with hypersensitivity reactions, compared with those who did not have prospective pharmacogenetic screening', 'participants in any setting, who were of any age, gender, and ethnicity, who had been prescribed drugs known to cause delayed type hypersensitivity reactions', '1956 adult participants (74% men, with a mean age of 42 years) across 265 centres (medical centres, hospitals, outpatient clinics) in 19 countries around the world who were infected with HIV-type 1 and who had not received abacavir previously', 'patients positive for HIV-type 1', 'Participants who tested positive for HLA-B*57:01 were not given']","['abacavir', 'antiretroviral therapy that did not include abacavir', 'human leukocyte antigen (HLA) Class I, locus B, allele 57:01 (HLA-B*57:01) screening (prospective-screening group) before this treatment, or to undergo a standard-care approach of abacavir use without prospective HLA-B*57:01 screening (control group', 'abacavir, GlaxoSmithKline']","['hypersensitivity reaction to abacavir', 'HSS reaction', 'severe skin rashes with systemic symptoms, and long-term effects', 'severe hypersensitivity skin reactions', 'hospitalisation, death, or long-term conditions resulting from drug injury', 'incidence of severe skin rashes with systemic symptoms (such as fever and multiple organ involvement), and long-term effects (such as scarring of eyelids or lung tissue', 'incidence of clinically diagnosed HSS reaction to abacavir', 'hospitalisation for drug-induced skin reactions, blistering skin reactions (such as SJS, hypersensitivity (HSS) syndrome), and death']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Testing'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0020522', 'cui_str': 'Delayed Hypersensitivity'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008897', 'cui_str': 'Human Class I Antigens'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023983', 'cui_str': 'Effects, Long-Term'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1408773', 'cui_str': 'Scar of skin of eyelid'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C1319688', 'cui_str': 'Blister - unit of product usage'}, {'cui': 'C0543698', 'cui_str': 'Hypersensitive syndrome'}]",1956.0,0.251494,"AUTHORS' CONCLUSIONS


Prospective screening for HLA-B*57:01 probably reduces severe hypersensitivity skin reactions to abacavir in patients positive for HIV-type 1.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Alfirevic', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Centre for Personalised Medicine, Block A: Waterhouse Building, 1-5 Brownlow Street, Liverpool, UK, L69 3GE.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': ''}, {'ForeName': 'Branka', 'Initials': 'B', 'LastName': 'Marinovic', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Harcourt-Smith', 'Affiliation': ''}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Jorgensen', 'Affiliation': ''}, {'ForeName': 'Tess E', 'Initials': 'TE', 'LastName': 'Cooper', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010891.pub2']
895,31287766,Efficacy Study of a Social Communication and Self-Regulation Intervention for School-Age Children With Autism Spectrum Disorder: A Randomized Controlled Trial.,"Purpose This study aimed to examine the initial efficacy of a parent-assisted blended intervention combining components of Structured TEACCHing and Social Thinking, designed to increase social communication and self-regulation concept knowledge in 1st and 2nd graders ( n = 17) diagnosed with autism spectrum disorder (ASD) and their parents. Method A randomized delayed treatment control group design with pre- and postintervention assessments of both parents and children was implemented within a community practice setting. Two follow-up assessments at 3 and 6 months postintervention were also completed. Results Overall, results indicate that the intervention is efficacious in teaching social communication and self-regulation concept knowledge to children with ASD and their parents. Both parents and children demonstrated an increase in social communication and self-regulation knowledge after participating in the Growing, Learning, and Living With Autism Group as compared to a delayed treatment control group. The effects of the intervention did not extend to parent-child interactions coded from video recordings. Child treatment effects were maintained at the 3- and 6-month follow-up assessments. Conclusions Preliminary efficacy of the Growing, Learning, and Living With Autism Group was established. Based on parent report at the conclusion of the intervention, this is a socially valid intervention for teaching social communication and self-regulation skills to school-age children with ASD. Supplemental Material https://doi.org/10.23641/asha.8637236.",2019,"Both parents and children demonstrated an increase in social communication and self-regulation knowledge after participating in the Growing, Learning, and Living With Autism Group as compared to a delayed treatment control group.","['Spectrum Disorder', 'children with ASD and their parents', 'school-age children with ASD', 'School-Age Children With Autism', '1st and 2nd graders ( n = 17) diagnosed with autism spectrum disorder (ASD) and their parents']","['Social Communication and Self-Regulation Intervention', 'parent-assisted blended intervention combining components of Structured TEACCHing and Social Thinking']",['social communication and self-regulation knowledge'],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",17.0,0.0154917,"Both parents and children demonstrated an increase in social communication and self-regulation knowledge after participating in the Growing, Learning, and Living With Autism Group as compared to a delayed treatment control group.","[{'ForeName': 'Sallie W', 'Initials': 'SW', 'LastName': 'Nowell', 'Affiliation': 'Frank Porter Graham Child Development Institute, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Watson', 'Affiliation': 'Department of Allied Health Sciences, Division of Speech and Hearing Sciences, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Boyd', 'Affiliation': ""Juniper Gardens Children's Project, The University of Kansas, Lawrence.""}, {'ForeName': 'Laura G', 'Initials': 'LG', 'LastName': 'Klinger', 'Affiliation': 'TEACCH Autism Program, The University of North Carolina at Chapel Hill.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-18-0093']
896,31841156,Exploring Patients' Experiences of Internet-Based Self-Management Support for Low Back Pain in Primary Care.,"OBJECTIVE


We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance.
DESIGN


Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial.
METHODS


Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically.
RESULTS


Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain).
CONCLUSIONS


The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention.",2019,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[""patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance"", 'Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population', 'Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population', 'for Low Back Pain in Primary Care']","['Internet-Based Self-Management Support', 'physiotherapist telephone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],15.0,0.0816618,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Stanford', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Yoganantham', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hay', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz312']
897,31228760,"Analgesia-first sedation in critically ill adults: A U.S. pilot, randomized controlled trial.","PURPOSE


To determine the feasibility of conducting a multicenter ICU RCT of AFS compared to either protocol-directed sedation (PDS) or both PDS and daily sedation interruption (DSI) in North America.
MATERIALS AND METHODS


This single-center RCT compared AFS [fentanyl (bolus ± infusions) to reach CPOT ≤2; if RASS ≥1, CPOT ≤2 and additional fentanyl failed to reach RASS goal (-2 to 0), low-dose propofol (up to 6 h) was given] with either PDS or both PDS and DSI daily in adults mechanically ventilated (MV) ≥48 h. Relevant feasibility, safety, and clinical outcomes were defined and evaluated.
RESULTS


90 of 160 eligible patients were enrolled [AFS = 27; PDS = 28; PDS + DSI = 31]; rate = 3/month. Time from intubation to randomization was 17.5 ± 11.6 h. Study days fully adherent to the study intervention [AFS = 95%; PDS = 99%; PDS + DSI = 96%] and time spent in the first 48 h after randomization without pain (CPOT ≤2)[AFS = 82%; PDS = 78%; PDS + DSI = 77%] and at goal RASS[AFS = 88%; PDS = 83%; PDS + DSI = 95%] were high and similar. Nurse-perceived [median (IQR)] study workload (10-point VAS) was higher with AFS [4(2-6)] than PDS [1(1-3)] or PDS + DSI [2(1-5)]; p = .002). Unplanned extubation was rare (AFS = 1; PDS = 0; PDS + DSI = 1). Days [median (IQR)] free of MV in the 28d after intubation [AFS 24(23,26); PDS 24(20,26); PDS + DSI 24(21,26)] was not different (p = .62).
CONCLUSION


A multicenter RCT evaluating AFS is feasible to conduct in North America.",2019,study workload (10-point VAS) was higher with AFS [4(2-6)] than PDS [1(1-3)] or PDS + DSI [2(1-5)];,"['North America', '90 of 160 eligible patients were enrolled [AFS\u202f=\u202f27; PDS\u202f=\u202f28; PDS\u202f+\u202fDSI\u202f=\u202f31]; rate\u202f=\u202f3/month', 'critically ill adults']","['Analgesia-first sedation', 'protocol-directed sedation (PDS) or both PDS and daily sedation interruption (DSI', 'propofol']","['Nurse-perceived [median (IQR', 'study workload (10-point VAS', 'Days [median (IQR)] free of MV', 'PDS 24(20,26); PDS\u202f+\u202fDSI 24(21,26', 'time spent', 'Unplanned extubation']","[{'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]",160.0,0.108096,study workload (10-point VAS) was higher with AFS [4(2-6)] than PDS [1(1-3)] or PDS + DSI [2(1-5)];,"[{'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Tanios', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Huan Mark', 'Initials': 'HM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pharmacy Practice and Administration, Western University of Health Sciences, Pomona, CA, United States of America.'}, {'ForeName': 'Hyunsoon', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Critical Care, Sinai Health System and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'Epstein', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, United States of America.'}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'Youssef', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Beltran', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Flores', 'Affiliation': 'Department of Critical Care, Universidad Autonoma de Guadalajara School of Medicine, Guadalajara, Mexico.'}, {'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Sidhom', 'Affiliation': 'Department of Internal Medicine, University of California Medical Center, Orange, CA, United States of America.'}, {'ForeName': 'Arunpal', 'Initials': 'A', 'LastName': 'Sehgal', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Leo', 'Affiliation': 'Department of Medicine, MemorialCare Health System, Fountain Valley, CA, United States of America.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Tufts Medical Center, United States of America; School of Pharmacy, Northeastern University, Boston, MA, United States of America. Electronic address: j.devlin@neu.edu.'}]",Journal of critical care,['10.1016/j.jcrc.2019.06.008']
898,31292752,Influence of a 3-month low-calorie Mediterranean diet compared to the vegetarian diet on human gut microbiota and SCFA: the CARDIVEG Study.,"PURPOSE


We evaluated the effect of low-calorie mediterranean (MD) and vegetarian (VD) diets on gut microbiome (GM) composition and short-chain-fatty acids (SCFA) production.
METHODS


We performed next generation sequencing (NGS) of 16S rRNA and SCFA analysis on fecal samples of 23 overweight omnivores (16 F; 7 M) with low-to-moderate cardiovascular risk. They were randomly assigned to a VD or MD, each lasting 3 months, with a crossover study design.
RESULTS


Dietary interventions did not produce significant diversity in the GM composition at higher ranks (family and above), neither between nor within MD and VD, but they did it at genus level. MD significantly changed the abundance of Enterorhabdus, Lachnoclostridium and Parabacteroides, while VD significantly affected the abundance of Anaerostipes, Streptococcus, Clostridium sensu stricto, and Odoribacter. Comparison of the mean variation of each SCFA between MD and VD showed an opposite and statistically significant trend for propionic acid (+ 10% vs - 28%, respectively, p = 0.034). In addition, variations of SCFA were negatively correlated with changes of some inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12, only after MD. Finally, correlation analyses showed a potential relationship-modulated by the two diets-between changes of genera and changes of clinical and biochemical parameters.
CONCLUSIONS


A short-term dietary intervention with MD or VD does not induce major change in the GM, suggesting that a diet should last longer than 3 months for scratching the microbial resilience. Changes in SCFA production support their role in modulating the inflammatory response, thus mediating the anti-inflammatory and protective properties of MD.",2020,"In addition, variations of SCFA were negatively correlated with changes of some inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12, only after MD.","['23 overweight omnivores (16 F; 7 M) with low-to-moderate cardiovascular risk', 'human gut microbiota and SCFA']","['low-calorie mediterranean (MD) and vegetarian (VD) diets', 'next generation sequencing (NGS) of 16S rRNA and SCFA analysis', 'vegetarian diet', 'low-calorie Mediterranean diet']","['propionic acid', 'inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12', 'abundance of Enterorhabdus, Lachnoclostridium and Parabacteroides', 'abundance of Anaerostipes, Streptococcus, Clostridium sensu stricto, and Odoribacter', 'gut microbiome (GM) composition and short-chain-fatty acids (SCFA) production', 'GM composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0562693', 'cui_str': 'Omnivore (organism)'}, {'cui': 'C1173706', 'cui_str': ""7-methoxy-6-(2'-methoxy-3'-hydroxy-3'-methyl butyl)""}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0072186', 'cui_str': 'Propionic acid'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides species'}, {'cui': 'C1224225', 'cui_str': 'Anaerostipes'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C1629861', 'cui_str': 'Genus Odoribacter'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C0033268'}]",,0.0239323,"In addition, variations of SCFA were negatively correlated with changes of some inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12, only after MD.","[{'ForeName': 'Giuditta', 'Initials': 'G', 'LastName': 'Pagliai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Edda', 'Initials': 'E', 'LastName': 'Russo', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Niccolai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dinu', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Pilato', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Magrini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Bartolucci', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health Section of Pharmaceutical and Nutraceutical Sciences, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Baldi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Menicatti', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health Section of Pharmaceutical and Nutraceutical Sciences, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy.'}, {'ForeName': 'Betti', 'Initials': 'B', 'LastName': 'Giusti', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Marcucci', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Rossolini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Casini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sofi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Amedei', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. amedeo.amedei@unifi.it.'}]",European journal of nutrition,['10.1007/s00394-019-02050-0']
899,31838596,Reduction of Streptococcus mutans by probiotic milk: a multicenter randomized controlled trial.,"OBJECTIVE


To investigate the effects of probiotics, Lactobacillus paracasei SD1, on the quantities of Streptococcus mutans in saliva and plaque samples of preschool children.
DESIGN


This randomized trial recruited 487 preschool children from eight childcare centers. Participants were assigned to receive a 6-month course of placebo milk daily (group I), probiotic milk either daily (group II) or three days a week (triweekly, group III). The absolute quantities of S. mutans and total lactobacilli in the saliva and plaque samples at baseline (T0), after intervention (T6), and 6 months after discontinuation (T12) were assessed by qPCR.
RESULTS


Of 487 children, 354 completed all follow-up periods. However, only 268 children (3.2 ± 0.8 years old; groups I = 86, II = 89, and III = 93) provided adequate saliva for qPCR. Whereas the quantities of S. mutans were significantly decreased in groups II and III compared to group I in the saliva and plaque samples at T6 and T12, those of total lactobacilli were significantly increased (p < 0.0167). There was no difference in the quantities of S. mutans or total lactobacilli between groups II and III at any period. Significant changes in the quantities of S. mutans and total lactobacilli lasted until T12 compared to T0 (p < 0.0167).
CONCLUSIONS


Probiotic administration daily or triweekly reduces S. mutans quantities, whereas it increases total lactobacilli quantities that persists at least 6 months after discontinuation in the saliva and plaque samples of preschool children.
CLINICAL RELEVANCE


Daily or triweekly consumption of L. paracasei SD1 supplemented in milk may help prevent dental caries in preschool children.",2020,There was no difference in the quantities of S. mutans or total lactobacilli between groups II and III at any period.,"['preschool children', 'Of 487 children, 354 completed all follow-up periods', '487 preschool children from eight childcare centers', '268 children (3.2 ± 0.8 years old; groups I = 86, II = 89, and III = 93) provided']","['probiotic milk', 'SD1', 'placebo milk daily (group I), probiotic milk either daily', 'probiotics, Lactobacillus paracasei SD1', 'L. paracasei']","['quantities of S. mutans and total lactobacilli', 'total lactobacilli quantities', 'absolute quantities of S. mutans and total lactobacilli', 'quantities of S. mutans or total lactobacilli', 'total lactobacilli', 'adequate saliva for qPCR', 'dental caries', 'quantities of S. mutans']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}]",487.0,0.0303064,There was no difference in the quantities of S. mutans or total lactobacilli between groups II and III at any period.,"[{'ForeName': 'Chanika', 'Initials': 'C', 'LastName': 'Manmontri', 'Affiliation': 'Division of Pediatric Dentistry, Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Areerat', 'Initials': 'A', 'LastName': 'Nirunsittirat', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Supatcharin', 'Initials': 'S', 'LastName': 'Piwat', 'Affiliation': 'Common Oral Diseases and Epidemiology Research Center, Faculty of Dentistry, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand.'}, {'ForeName': 'Onnida', 'Initials': 'O', 'LastName': 'Wattanarat', 'Affiliation': 'Division of Pediatric Dentistry, Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Nuntiya', 'Initials': 'N', 'LastName': 'Pahumunto', 'Affiliation': 'Common Oral Diseases and Epidemiology Research Center, Faculty of Dentistry, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand.'}, {'ForeName': 'Anupong', 'Initials': 'A', 'LastName': 'Makeudom', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Thanapat', 'Initials': 'T', 'LastName': 'Sastraruji', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Suttichai', 'Initials': 'S', 'LastName': 'Krisanaprakornkit', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Rawee', 'Initials': 'R', 'LastName': 'Teanpaisan', 'Affiliation': 'Common Oral Diseases and Epidemiology Research Center, Faculty of Dentistry, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand. rawee.t@psu.ac.th.'}]",Clinical oral investigations,['10.1007/s00784-019-03095-5']
900,31327047,Is Bacillus coagulans supplementation plus low FODMAP diet superior to low FODMAP diet in irritable bowel syndrome management?,"PURPOSE


The aim of this study was to assess the superiority of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet plus Bacillus coagulans supplementation to low FODMAP diet alone in the reduction of irritable bowel syndrome (IBS) symptoms.
METHODS


In this randomized clinical trial, fifty IBS patients who met Rome IV criteria for IBS were randomly assigned to receive a low FODMAP diet plus either a probiotic or a placebo capsule for 8 weeks. Probiotic capsules contained 10 9 B. coagulans spores and 400 mg inulin, while placebo capsules consisted of 500 mg rice starch.
RESULTS


Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001). Moreover, the frequency of patients with clinical improvement in IBS-symptom severity scale (IBS-SSS) was significantly more in probiotic group compared to placebo group (P = 0.038).
CONCLUSION


Our results indicate that the addition of probiotic supplement containing B. coagulans to the low FODMAP diet might be superior to low FODMAP diet in alleviating IBS symptoms.",2020,"RESULTS


Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001).",['fifty IBS patients who met Rome IV criteria for IBS'],"['FODMAP diet superior to low FODMAP diet', 'placebo', 'low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet plus Bacillus coagulans supplementation to low FODMAP diet alone', 'low FODMAP diet plus either a probiotic or a placebo capsule', 'placebo capsules consisted of 500\xa0mg rice starch']","['severity score', 'IBS-symptom severity scale (IBS-SSS', 'irritable bowel syndrome (IBS) symptoms', 'abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C4552346', 'cui_str': 'FODMAP diet'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0012611', 'cui_str': 'Disaccharides'}, {'cui': 'C0026492', 'cui_str': 'Simple Sugars'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0947613', 'cui_str': 'STARCH, RICE'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0034380'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",50.0,0.135522,"RESULTS


Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001).","[{'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Abhari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeede', 'Initials': 'S', 'LastName': 'Saadati', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hosseini-Oskouiee', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Department of Food Technology, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Hejazi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. a_hekmat2000@yahoo.com.'}]",European journal of nutrition,['10.1007/s00394-019-02060-y']
901,31326395,"A Phase IV, Randomized, Double-Blind, Placebo-Controlled Crossover Study of the Effects of Ustekinumab on Vascular Inflammation in Psoriasis (the VIP-U Trial).","Psoriasis is a T helper type 17 autoimmune disease associated with an increased risk cardiovascular events and mortality. Ustekinumab, an antibody to p40, blocks cytokines IL-12 and IL-23, and is a highly effective and safe treatment for psoriasis. We conducted a randomized double-blinded placebo-controlled trial to determine the effect of ustekinumab on aortic vascular inflammation (AVI) measured by imaging, and key biomarkers of inflammation, lipid, and glucose metabolism in the blood of patients with moderate-to-severe psoriasis. A total of 43 patients were randomized, and at week 12, ustekinumab-treated patients had a -18.65% (95% confidence interval = -29.45% to -7.85%) reduction in AVI, a reduction in inflammatory biomarkers, and an increase in apolipoprotein B lipoproteins compared with placebo. At week 12, placebo patients were crossed over such that all patients received ustekinumab for 52 weeks. At the end of 52 weeks of ustekinumab treatment, there was no change in AVI compared with baseline, inflammatory markers were reduced, and there were increases in selected measures of lipids and leptin. These results show that blockade of IL-12 and/or IL-23 may transiently reduce AVI, with more durable reduction in inflammatory cytokines associated with cardiovascular disease.",2020,"At the end of 52 weeks of ustekinumab treatment there was no change in aortic vascular inflammation compared to baseline, inflammatory markers were reduced and there were increases in selected measures of lipids and leptin.
","['patients with moderate to severe psoriasis', '43 patients']","['placebo', 'Placebo', 'ustekinumab', 'Ustekinumab']","['apolipoprotein-B lipoproteins', 'inflammatory markers', 'aortic vascular inflammation', 'selected measures of lipids and leptin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0947751', 'cui_str': 'Vascular inflammations'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0299583', 'cui_str': 'leptin'}]",43.0,0.557078,"At the end of 52 weeks of ustekinumab treatment there was no change in aortic vascular inflammation compared to baseline, inflammatory markers were reduced and there were increases in selected measures of lipids and leptin.
","[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Gelfand', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Electronic address: Joel.Gelfand@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Abass', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Department of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Torigian', 'Affiliation': 'Department of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Werner', 'Affiliation': 'Department of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Maryte', 'Initials': 'M', 'LastName': 'Papadopoulos', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Megan H', 'Initials': 'MH', 'LastName': 'Noe', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Dey', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.07.679']
902,32406746,[High intensity interval training increases the utilization of fatty acids in subjects with overweight or obesity. A randomized study].,"Introduction


Introduction: the effect of high intensity interval training (HIIT) on fat utilization during exercise needs to be studied in depth. Objective: to determine the effect of HIIT training program in subjects with overweight or obesity on the use of fat during exercise, body composition and cardiovascular variables. The second objective was to compare the variables according to the duration of the program (i.e., 12, 16 and 20 weeks). Material and methods: 30 subjects were studied (age 44.8 ± 11.6 years). Three groups were formed at random, the G1 (12 weeks, n = 12, 48.08 ± 8.20 years), G2 (16 weeks, n = 10, 42.10 ± 11.60 years) and G3 (20 weeks, n = 8, 43.38 ± 15.76 years). All groups performed HIIT 3 times per week. Results: the three groups showed a significant decrease in body fat percentage (p < 0.05), without differences between groups. Similarly, cardiovascular variables did not report differences between groups (p-interaction > 0.05) after the intervention; however, the groups reported a significant decrease systolic blood pressure (p < 0, 05). In the pre vs. post analysis by groups, the three groups showed improvements in VO2max without differences between groups (p-interaction > 0.05). Finally, the three groups increased the fats utilization during exercise (p < 0.05). Conclusion: the program increased fat utilization during exercise, decreased body fat % and improved cardiovascular parameters, however after 12 training weeks it is advisable to apply variations to training to maximize results.",2020,"the three groups showed a significant decrease in body fat percentage (p < 0.05), without differences between groups.","['subjects with overweight or obesity on the use of fat during exercise, body composition and cardiovascular variables', 'subjects with overweight or obesity', '30 subjects were studied (age 44.8 ± 11.6 years']","['High intensity interval training', 'HIIT training program', 'high intensity interval training (HIIT']","['fats utilization', 'body fat percentage', 'fat utilization during exercise, decreased body fat % and improved cardiovascular parameters', 'VO2max', 'systolic blood pressure', 'utilization of fatty acids', 'cardiovascular variables']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",30.0,0.0214989,"the three groups showed a significant decrease in body fat percentage (p < 0.05), without differences between groups.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moris', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación. Universidad de la Frontera.'}, {'ForeName': 'Pedro Antonio', 'Initials': 'PA', 'LastName': 'Delgado Floody', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación. Universidad de la Frontera.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Martínez Salazar', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación. Universidad de la Frontera.'}]",Nutricion hospitalaria,['10.20960/nh.02940']
903,31315150,A pilot randomized controlled trial of a gratitude intervention for adolescents with Type 1 diabetes.,"AIM


Cost-effective psychosocial interventions that can feasibly be implemented into busy clinical settings are needed to improve psychological and physical health outcomes in adolescents with Type 1 diabetes. We examined the efficacy of a gratitude journalling intervention to improve psychological well-being and glycaemic control in adolescents aged 10-16 years with Type 1 diabetes.
METHODS


Eighty adolescents were randomized to the 8-week gratitude intervention (N = 40) or standard care (N = 40). Self-reported measures of stress, quality of life, self-care, depression and gratitude were assessed at baseline and 8 weeks after baseline. Glycaemic control (HbA 1c  ) was assessed at baseline and 12 weeks after baseline. A per-protocol analysis was conducted with the adolescents who completed all questionnaires (N = 60). Analysis of covariance (ANCOVA) was used to examine differences between treatment arms at follow-up adjusting for baseline scores.
RESULTS


There was no evidence of any between-group differences in the psychological or behavioural measures at follow-up (all P-values > 0.05). Glycaemic control slightly increased in the control group while remaining stable in the gratitude group, with a between-group difference of 6.1 mmol/mol [95% confidence interval (CI) -2.6 to 14.7; 0.6%, 95% CI -0.2 to 1.3] at 12 weeks after baseline. After adjusting for baseline HbA 1c  , this between-group difference was significant (P = 0.048).
CONCLUSIONS


This is the first randomized trial of a gratitude journalling intervention for adolescents with Type 1 diabetes. Gratitude journalling interventions represent a clinically usable approach. If and how it helps to stabilise glycaemic control in adolescents with Type 1 diabetes remains to be confirmed in future research.",2020,There was no evidence of any between-group differences in the psychological or behavioural measures at follow-up (all P-values > 0.05).,"['Eighty adolescents', 'adolescents with Type 1 diabetes', 'adolescents aged 10-16 years with Type 1 diabetes']","['gratitude intervention', 'gratitude journalling intervention', 'gratitude intervention (N\xa0=\xa040) or standard care']","['Glycaemic control slightly', 'stress, quality of life, self-care, depression and gratitude', 'psychological or behavioural measures', 'Glycaemic control (HbA 1c  ']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034380'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",80.0,0.0876569,There was no evidence of any between-group differences in the psychological or behavioural measures at follow-up (all P-values > 0.05).,"[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14078']
904,31315446,"Monthly Video-Consultation for Children With Type 1 Diabetes Using a Continuous Glucose Monitoring System: Design of ViDiKi, a Multimethod Intervention Study to Evaluate the Benefit of Telemedicine.","BACKGROUND


The introduction of continuous glucose monitoring (CGM) implies new challenges for diabetes care. As CGM systems are often directly linked to a web-based software solution, structured telemedicine care using a video-consultation may be a new option for families who care for children with type 1 diabetes mellitus (T1DM).
METHODS


""ViDiKi"" (Virtual Diabetes Outpatient Clinic for Children and Youth) is a multicenter controlled trial carried out in Northern Germany. ViDiKi will examine if monthly telemedical consultations, in addition to regular care, will improve glycemic control and psychosocial outcomes. The primary outcome is glycemic control as measured by a change in glycated hemoglobin (HbA1c). A total of 240 participants aged between one year and 16 years using a CGM with multiple daily injections (MDI) or insulin pump therapy were recruited and assigned to a starter group or a six-month waiting control group. The sample size is designed to detect a between-group difference of 0.5% in HbA1c change at six months. Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine. To gain deeper insight into the experience of using telemedicine, qualitative interviews will be conducted. In a health-economic analysis, the costs of telemedicine and a cost-of-care analysis will be calculated.
CONCLUSIONS


The results from the ViDiKi study shall give important information on the feasibility and putative benefits of telemedicine in children with T1DM and their caregivers.
GERMAN CLINICAL TRAILS REGISTER (DRKS)


DRKS00012645.",2020,"Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine.","['Northern Germany', 'children with T1DM and their caregivers', 'ViDiKi"" (Virtual Diabetes Outpatient Clinic for Children and Youth', '240 participants aged between one year and 16 years using a', 'families who care for children with type 1 diabetes mellitus (T1DM', 'Children']","['CGM with multiple daily injections (MDI) or insulin pump therapy', 'telemedicine', 'continuous glucose monitoring (CGM', 'starter group or a six-month waiting control group', 'Telemedicine']","['glycemic control as measured by a change in glycated hemoglobin (HbA1c', 'variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine']","[{'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]",240.0,0.0839175,"Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine.","[{'ForeName': 'Fabian-Simon', 'Initials': 'FS', 'LastName': 'Frielitz', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Luebeck, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Müller-Godeffroy', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, University Medical Center, Campus Luebeck, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Hübner', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Luebeck, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Eisemann', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Luebeck, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Dördelmann', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Luebeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Menrath', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, University Medical Center, Campus Luebeck, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Katalinic', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Luebeck, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Hiort', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, University Medical Center, Campus Luebeck, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'von Sengbusch', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, University Medical Center, Campus Luebeck, Germany.'}]",Journal of diabetes science and technology,['10.1177/1932296819861991']
905,31295558,Validity and reliability of test strips for the measurement of salivary nitrite concentration with and without the use of mouthwash in healthy adults.,"The nitrate (NO 3 - )-nitrite (NO 2 - )-nitric oxide (NO) pathway has received considerable interest in recent years as a potential target for nutritional interventions designed to increase NO production, and elicit therapeutic effects in humans. In particular, studies have evaluated the effects of supplemental dietary NO 3 - , which serves as a 'substrate' for this pathway, on numerous different health outcomes. One challenge has been to evaluate compliance with the NO 3 -  interventions. A recent advance in this field has been the development of a non-invasive, simple and rapid method to measure nitrite concentrations in saliva using small test salivary strips. In the present study, ten healthy adults were recruited to a randomised, crossover study and received an acute dose of NO 3 - -rich beetroot juice (BJ) after rinsing their mouth with either water or commercially available antibacterial mouthwash. Salivary NO 3 -  and NO 2 -  concentrations were measured at baseline and up to 5 h after BJ consumption using the gold-standard chemiluminescence and a colorimetric Griess assay. In addition, two salivary test strips (Berkeley Test strips, CA, USA) were used to measure NO 2 - concentrations at the same time points. Five observers read the strips and inter- and intra-observer reliability was measured. The Bland-Altman method was used to provide a visual representation of the agreement between the methods used to evaluate salivary NO 3 - /NO 2 - concentration. Sialin concentrations were measured at baseline and up to 5 h after BJ consumption. BJ elevated salivary NO 3 -  and NO 2 -  concentrations when the mouth was rinsed with water (both P < 0.01), as assessed via both chemiluminescence and Griess methods. Rinsing the mouth with antibacterial mouthwash attenuated markedly the increase in NO 2 -  (P < 0.001), while NO 3 - concentrations were unaffected (P > 0.05). The Intra-Class Coefficients of Correlation (ICC) showed a high inter- and intra-observer reliability (r > 0.8). A significant positive correlation was found between absolute salivary NO 2 -  concentrations measured by strips and Griess and chemiluminescence methods (rho = 0.83 and 0.77, respectively) and also when expressed as changes in salivary NO 2 -  concentrations (rho = 0.80 and 0.79, respectively). Bland Altman analysis indicated a poor agreement for absolute NO 2 -  concentrations between salivary strips and the chemiluminescence and Griess methods. A small significant negative correlation was found between changes in salivary sialin and salivary NO 2 - concentrations (r = -0.20, P = 0.04). A non-significant positive correlation was observed between the change in salivary sialin and salivary NO 3 - concentrations (r = 0.18, P = 0.06). This study suggests that commercially available salivary NO 2 -  test strips provide a reasonable surrogate marker for monitoring changes in salivary NO 2 -  concentrations in humans. However, the strips do not provide accurate estimates of absolute NO 2 -  concentrations.",2019,"Rinsing the mouth with antibacterial mouthwash attenuated markedly the increase in NO 2 -  (P < 0.001), while NO 3 - concentrations were unaffected (P > 0.05).","['healthy adults', 'ten healthy adults']","['Salivary', 'NO 3 - -rich beetroot juice (BJ) after rinsing their mouth with either water or commercially available antibacterial mouthwash']","['Sialin concentrations', 'salivary sialin and salivary NO 2 - concentrations', 'NO 3 -  and NO 2 -  concentrations', 'absolute salivary NO 2 -  concentrations measured by strips and Griess and chemiluminescence methods', 'salivary sialin and salivary NO 3 - concentrations', 'NO 2 ', 'BJ elevated salivary NO 3 -  and NO 2 -  concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0162524', 'cui_str': 'Chemiluminescence'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",10.0,0.0390093,"Rinsing the mouth with antibacterial mouthwash attenuated markedly the increase in NO 2 -  (P < 0.001), while NO 3 - concentrations were unaffected (P > 0.05).","[{'ForeName': 'Abrar M', 'Initials': 'AM', 'LastName': 'Babateen', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK; Faculty of Applied Medical Sciences, Clinical Nutrition Department, Umm Al-Qura University, Makkah, Saudi Arabia. Electronic address: a.m.o.babateen2@ncl.ac.uk.'}, {'ForeName': 'Oliver M', 'Initials': 'OM', 'LastName': 'Shannon', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': ""Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK; School of Life Sciences, The University of Nottingham Medical School, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2019.07.002']
906,31701524,Proposed Therapeutic Range of Treosulfan in Reduced Toxicity Pediatric Allogeneic Hematopoietic Stem Cell Transplant Conditioning: Results From a Prospective Trial.,"Treosulfan is given off-label in pediatric allogeneic hematopoietic stem cell transplant. This study investigated treosulfan's pharmacokinetics (PKs), efficacy, and safety in a prospective trial. Pediatric patients (n = 87) receiving treosulfan-fludarabine conditioning were followed for at least 1 year posttransplant. PKs were described with a two-compartment model. During follow-up, 11 of 87 patients died and 12 of 87 patients had low engraftment (≤ 20% myeloid chimerism). For each increase in treosulfan area under the curve from zero to infinity (AUC (0-∞)  ) of 1,000 mg hour/L the hazard ratio (95% confidence interval) for mortality increase was 1.46 (1.23-1.74), and the hazard ratio for low engraftment was 0.61 (0.36-1.04). A cumulative AUC (0-∞)  of 4,800 mg hour/L maximized the probability of success (> 20% engraftment and no mortality) at 82%. Probability of success with AUC (0-∞)  between 80% and 125% of this target were 78% and 79%. Measuring PK at the first dose and individualizing the third dose may be required in nonmalignant disease.",2020,hour/L maximized the probability of success (> 20% engraftment and no mortality) at 82%.,"['Pediatric patients (n\xa0=\xa087) receiving', 'Toxicity Pediatric Allogeneic Hematopoietic Stem Cell Transplant Conditioning', 'pediatric allogeneic hematopoietic stem cell transplant']",['treosulfan-fludarabine'],"['probability of success', 'hazard ratio for low engraftment', 'low engraftment', 'mortality increase']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0076959', 'cui_str': 'treosulfan'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",87.0,0.132641,hour/L maximized the probability of success (> 20% engraftment and no mortality) at 82%.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chiesa', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Standing', 'Affiliation': 'Pharmacy Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Winter', 'Affiliation': 'Chemical Pathology Department, Great Ormond Street Hospital for Children,, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Nademi', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Pinner', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kloprogge', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McLellen', 'Affiliation': 'Clinical Biochemistry, Integrated Laboratory Medicine Directorate, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Persis J', 'Initials': 'PJ', 'LastName': 'Amrolia', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Kanchan', 'Initials': 'K', 'LastName': 'Rao', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Lucchini', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Silva', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Ciocarlie', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Arina', 'Initials': 'A', 'LastName': 'Lazareva', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gennery', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Bilyana', 'Initials': 'B', 'LastName': 'Doncheva', 'Affiliation': 'Pharmacy Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cant', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hambleton', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Flood', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rogerson', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Devine', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Prunty', 'Affiliation': 'Chemical Pathology Department, Great Ormond Street Hospital for Children,, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heales', 'Affiliation': 'Chemical Pathology Department, Great Ormond Street Hospital for Children,, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Veys', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Slatter', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1715']
907,31280343,Pre-meal protein intake alters postprandial plasma metabolome in subjects with metabolic syndrome.,"PURPOSE


We examined the effect on the postprandial plasma metabolome of protein pre-meals before a fat-rich main meal.
METHODS


Two randomized, cross-over meal studies were conducted to test the dose-response effect (0 g, 10 g, 20 g) of a pre-meal with whey protein (WP) (PREMEAL I), and the effect of protein quality (10 g WP, casein, or gluten) and timing (- 15 min vs - 30 min) of the pre-meal (PREMEAL II). Participants with metabolic syndrome received one of the test meals on each test day, - 15 min (or - 30 min) prior to a standardized fat-rich breakfast. Plasma samples were collected at - 15 min (or - 30 min), 0, 120, 240 a nd 360 min and analyzed using liquid chromatography-mass spectrometry with an untargeted method.
RESULTS


Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels before the main meal. Early (- 15 to 0 min) aromatic amino acids and BCAA in response to pre-meal WP partially predict the glucose and insulin response after the main meal. A pre-meal with WP altered the postprandial plasma metabolic pattern of acyl-carnitines, specific PCs, LPCs and LPEs, betaine, citric acid, linoleic acid, and β-hydroxypalmitic acid compared to no pre-meal. The casein and WP pre-meals exhibited similar postprandial amino acid responses whereas a pre-meal with gluten resulted in lower levels of plasma amino acids and its metabolites.
CONCLUSION


A pre-meal with protein affects the postprandial metabolic pattern indicating facilitated glucose and lipid disposal from plasma in participants with metabolic syndrome.",2020,"Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels before the main meal.","['subjects with metabolic syndrome', 'participants with metabolic syndrome', 'Participants with metabolic syndrome']","['Pre-meal protein intake', 'pre-meal with whey protein (WP']","['postprandial amino acid responses', 'plasma amino acids and its metabolites', 'Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels', 'glucose and insulin response', 'postprandial plasma metabolic pattern of acyl-carnitines, specific PCs, LPCs and LPEs, betaine, citric acid, linoleic acid, and β-hydroxypalmitic acid', 'postprandial metabolic pattern indicating facilitated glucose and lipid disposal from plasma']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0301713', 'cui_str': 'Aromatic Amino Acids'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",,0.0271201,"Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels before the main meal.","[{'ForeName': 'Ceyda Tugba', 'Initials': 'CT', 'LastName': 'Pekmez', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark. ctp@nexs.ku.dk.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bjørnshave', 'Affiliation': 'Department Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pratico', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark.'}]",European journal of nutrition,['10.1007/s00394-019-02039-9']
908,31282698,Suggestion of cognitive enhancement improves emotion regulation.,"Cognitive training seems a promising approach to enhance emotion regulation. To establish a causal connection, researchers must compare the training intervention with a control group that accounts for improvements induced by some factors other than the training. Despite this familiar methodology, the influence of expectations on the transfer effects of training remains poorly understood. We tested this possibility in 2 experiments, where a procedure was designed to intentionally induce a placebo effect via the suggestion of cognitive enhancement to evaluate the role of expectation in emotion regulation gains from cognitive training. Both the Placebo and Control groups completed the identical short-term working memory training (20 min) in Experiment 1. New participants were recruited to complete a long-term pseudotraining program (7 days) in Experiment 2. The results from the 2 experiments consistently showed that the Placebo group, who expected benefits from the training, unlike the Control group, showed less negative emotion and better regulatory effects after pseudotraining, irrespective of the duration of the training. Thus, inadequate control of expectation is a fundamental design flaw that potentially undermines any causal inferences. These findings also suggest a novel perspective for optimizing the experimental designs in psychological interventions and advancing the understanding of emotion regulation enhancement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The results from the 2 experiments consistently showed that the Placebo group, who expected benefits from the training, unlike the Control group, showed less negative emotion and better regulatory effects after pseudotraining, irrespective of the duration of the training.",['New participants were recruited to complete a long-term pseudotraining program (7 days) in Experiment 2'],"['Placebo', 'Cognitive training']","['emotion regulation', 'negative emotion and better regulatory effects']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0259245,"The results from the 2 experiments consistently showed that the Placebo group, who expected benefits from the training, unlike the Control group, showed less negative emotion and better regulatory effects after pseudotraining, irrespective of the duration of the training.","[{'ForeName': 'Quanshan', 'Initials': 'Q', 'LastName': 'Long', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Hanxiao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Center for Brain Imaging.'}, {'ForeName': 'Jiajin', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Antao', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000629']
909,31249394,Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma.,"BACKGROUND


Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection.
METHODS


To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed.
RESULTS


Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein (R 2 : 0.75; P < 2 × 10 -16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients.
CONCLUSION


Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience.
CLINICAL TRIAL REGISTRATION


NCT01761266.",2019,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.",['hepatocellular carcinoma'],['lenvatinib vs sorafenib'],['UPCR and 24-hour urine protein'],"[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}]",,0.0399609,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.","[{'ForeName': 'Thomas R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. j.evans@beatson.gla.ac.uk.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'David Geffen School of Medicine, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Severance Hospital, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Silvija', 'Initials': 'S', 'LastName': 'Kraljevic', 'Affiliation': 'Former employee of Eisai Ltd, Hatfield, UK.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Piscaglia', 'Affiliation': 'Unit of Internal Medicine, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Max W', 'Initials': 'MW', 'LastName': 'Sung', 'Affiliation': 'Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-019-0506-6']
910,31273686,Cost-Effectiveness of Three Alternative Boosted Protease Inhibitor-Based Second-Line Regimens in HIV-Infected Patients in West and Central Africa.,"BACKGROUND


While dolutegravir has been added by WHO as a preferred second-line option for the treatment of HIV infection, boosted protease inhibitor (bPI)-based regimens are still needed as alternative second-line options. Identifying optimal bPI-based second-line combinations is essential, given associated high costs and funding constraints in low- and middle-income countries. We assessed the cost-effectiveness of three alternative bPI-based second-line regimens in Burkina Faso, Cameroon and Senegal.
METHODS


We used data collected over 2010-2015 in the 2LADY trial/post-trial cohort. Patients with first-line antiretroviral therapy (ART) failure were randomly assigned to tenofovir/emtricitabine + lopinavir/ritonavir (TDF/FTC LPV/r; arm A), abacavir + didanosine + lopinavir/ritonavir (arm B), or tenofovir/emtricitabine + darunavir/ritonavir (arm C). Costs (US dollars, 2016), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios were computed for each country over 24 months of follow-up and extrapolated to 5 years using a simulated patient-level Markov model. We assessed uncertainty using cost-effectiveness acceptability curves, scenarios and prices threshold analysis.
RESULTS


In each country, over 24 months, arm A was significantly less costly than arms B and C (incremental costs ranging from US$410-$US721 and US$468-US$546 for B and C vs A, respectively) and offered similar health benefits (incremental QALY: - 0.138 to 0.023 and - 0.179 to 0.028, respectively). Over 5 years, arm A remained the least costly, health benefits not being significantly different between arms. Compared with arms B and C, in each study country, Arm A had a ≥ 95% probability of being cost-effective for a large range of cost-effectiveness thresholds, irrespective of the scenario considered.
CONCLUSIONS


Using TDF/FTC LPV/r as a bPI-based second-line regimen provided the best economic value in the three study countries.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT00928187.",2020,"In each country, over 24 months, arm A was significantly less costly than arms B and C (incremental costs ranging from US$410-$US721 and US$468-US$546 for B and C vs A, respectively) and offered similar health benefits (incremental QALY: - 0.138 to 0.023 and - 0.179 to 0.028, respectively).","['Patients with first-line antiretroviral therapy (ART) failure', 'HIV-Infected Patients in West and Central Africa']","['tenofovir/emtricitabine\u2009+\u2009lopinavir/ritonavir (TDF/FTC LPV/r; arm A), abacavir\u2009+\u2009didanosine\u2009+\u2009lopinavir/ritonavir (arm B), or tenofovir/emtricitabine\u2009+\u2009darunavir/ritonavir (arm C', 'Three Alternative Boosted Protease Inhibitor-Based Second-Line Regimens']","['Cost-Effectiveness', 'Costs (US dollars, 2016), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001740', 'cui_str': 'Africa, Central'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir / Ritonavir'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0012133', 'cui_str': 'Didanosine'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0967433,"In each country, over 24 months, arm A was significantly less costly than arms B and C (incremental costs ranging from US$410-$US721 and US$468-US$546 for B and C vs A, respectively) and offered similar health benefits (incremental QALY: - 0.138 to 0.023 and - 0.179 to 0.028, respectively).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boyer', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Nishimwe', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France. marie.nishimwe@inserm.fr.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sagaon-Teyssier', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'March', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD), INSERM U1175, University of Montpellier, Montpellier, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koulla-Shiro', 'Affiliation': 'Infectious Diseases Department, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'M-Q', 'Initials': 'MQ', 'LastName': 'Bousmah', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Toby', 'Affiliation': 'Day Care Unit, Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Mpoudi-Etame', 'Affiliation': 'Epidemiology and Infectious Diseases Service, Region 1 Military Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Ngom Gueye', 'Affiliation': 'Ambulatory Care Unit, Fann Hospital, Dakar, Senegal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sawadogo', 'Affiliation': 'Day Care Unit, University Hospital Souro Sanou, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ciaffi', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD), INSERM U1175, University of Montpellier, Montpellier, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Spire', 'Affiliation': ""Aix Marseille Univ, INSERM, SESSTIM, IRD, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD), INSERM U1175, University of Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics - open,['10.1007/s41669-019-0157-9']
911,32030911,Increased Visceral Adipose Tissue Without Weight Retention at 59 Weeks Postpartum.,"OBJECTIVE


This study aimed to determine whether controlling maternal gestational weight gain (GWG) influences adipose tissue distribution at 1 year postpartum.
METHODS


Women with overweight or obesity (n = 210, BMI ≥ 25 or ≥ 30) were randomized to a lifestyle intervention (LI) designed to control GWG or to usual obstetrical care (UC). Measures included anthropometry, whole-body magnetic resonance imaging for visceral (VAT), intermuscular, and subcutaneous adipose tissue, and cardiometabolic risk factors in pregnancy (15 and 35 weeks) and after delivery (15 and 59 weeks).
RESULTS


Baseline (15 weeks) characteristics were similar (mean [SD]: age, 33.8 [4.3] years; weight, 81.9 [13.7] kg; BMI, 30.4 [4.5]; gestational age at randomization, 14.9 [0.8] weeks). LI had less GWG (1.79 kg; P = 0.003) and subcutaneous adipose tissue gain at 35 weeks gestation (P < 0.01). UC postpartum weight (2.92 kg) was higher at 15 weeks but not different from baseline or LI at 59 weeks postpartum. Postpartum VAT increased from baseline in LI by 0.23 kg at 15 weeks and 0.55 kg at 59 weeks; in UC, it increased by 0.34 kg at 15 and 59 weeks. Intermuscular adipose tissue remained elevated in LI (0.22 kg) at 59 weeks. VAT was associated with several cardiometabolic risk factors at 59 weeks.
CONCLUSIONS


Despite no weight retention at 59 weeks postpartum, women had increased VAT by ~30%. Postpartum modifiable behaviors are warranted to lower the risk of VAT retention.",2020,LI had less GWG (1.79 kg; P = 0.003) and subcutaneous adipose tissue gain at 35 weeks gestation (P < 0.01).,"['33.8 [4.3] years; weight, 81.9 [13.7] kg; BMI, 30.4 [4.5]; gestational age at randomization, 14.9 [0.8] weeks', 'Women with overweight or obesity (n\u2009']","['lifestyle intervention (LI) designed\xa0to control GWG or to usual obstetrical care (UC', 'VAT']","['Postpartum VAT', 'Intermuscular adipose tissue remained elevated in LI', 'UC postpartum weight', 'GWG', 'Increased Visceral Adipose Tissue Without Weight Retention', 'maternal gestational weight gain (GWG) influences adipose tissue distribution', 'anthropometry, whole-body magnetic resonance imaging for visceral (VAT), intermuscular, and subcutaneous adipose tissue, and cardiometabolic risk factors in pregnancy', 'subcutaneous adipose tissue gain', 'several cardiometabolic risk factors', 'weight retention']","[{'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205484', 'cui_str': 'Obstetrical (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",,0.1477,LI had less GWG (1.79 kg; P = 0.003) and subcutaneous adipose tissue gain at 35 weeks gestation (P < 0.01).,"[{'ForeName': 'Isaiah', 'Initials': 'I', 'LastName': 'Janumala', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Toro-Ramos', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Widen', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Rosenn', 'Affiliation': 'Department of Obstetrics and Gynecology, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Crane', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Center for Family and Community Medicine, Columbia University, New York, New York, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Gidwani', 'Affiliation': 'Department of Pediatrics, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Paley', 'Affiliation': 'Department of Pediatrics, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Thornton', 'Affiliation': 'Thornton Consulting, Mahopac, New York, USA.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22736']
912,31246895,"Associations between change in blood pressure and functional outcome, early events and death: results from the Efficacy of Nitric Oxide in Stroke trial.","OBJECTIVES


High blood pressure (BP) is associated with a poor outcome after acute stroke. Early reduction in BP may be associated with fewer early adverse events and deaths, and improved functional outcome.
METHODS


Analyses used data from the Efficacy of Nitric Oxide in Stroke trial, a multicentre randomized single-masked and outcome-masked trial of glyceryl trinitrate vs. no glyceryl trinitrate in 4011 patients recruited within 48 h of an ischaemic or haemorrhagic stroke and with raised SBP (140-220 mmHg). Change in SBP from baseline to day 1 was categorized as: more than 15% decrease, 15-5% decrease, 5% decrease to 5% increase (no change - reference) and more than 5% increase. The primary outcome was functional outcome (modified Rankin scale) score at 90 days.
RESULTS


Across all patients, both moderate (5-15%) and large (>15%) decreases in SBP were associated with beneficial shifts in the modified Rankin scale relative to patients with no change in BP: adjusted common odds ratio (OR) 0.81 [95% confidence interval (CI) 0.70-0.90] and OR 0.84 (95% CI 0.71-1.00), respectively. A moderate decrease in SBP was also associated with a lower risk of early adverse events, adjusted OR 0.69 (95% CI 0.52-0.90).
CONCLUSION


Modest decreases in SBP in acute stroke appear to be associated with fewer early events and better long-term functional outcome.",2019,"A moderate decrease in SBP was also associated with a lower risk of early adverse events, adjusted OR 0.69 (95% CI 0.52-0.90).
",['4011 patients recruited within 48\u200ah of an ischaemic or haemorrhagic stroke and with raised SBP (140-220\u200ammHg'],"['glyceryl trinitrate vs. no glyceryl trinitrate', 'Nitric Oxide']","['SBP', 'Change in SBP', 'functional outcome (modified Rankin scale) score', 'blood pressure and functional outcome, early events and death', 'functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4011.0,0.17742,"A moderate decrease in SBP was also associated with a lower risk of early adverse events, adjusted OR 0.69 (95% CI 0.52-0.90).
","[{'ForeName': 'Else C', 'Initials': 'EC', 'LastName': 'Sandset', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Appleton', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Berge', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gommans', 'Affiliation': ""Hawke's Bay Hospital, Hastings, New Zealand.""}, {'ForeName': 'Kailash', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Medicine, University of Thessaly, Greece.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Division of Neurology, Department of Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Woodhouse', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hypertension,['10.1097/HJH.0000000000002154']
913,31264294,Model-based analysis on systemic availability of co-administered cannabinoids after controlled vaporised administration.,"BACKGROUND


The most important two medicinal cannabinoids are Δ 9  -tetrahydrocannabinol (THC) and cannabidiol (CBD). Vaporised administration is superior due to its higher systemic availability, lower individual variability and faster drug delivery. Although it is common THC is co-administered with CBD, the influence of CBD on the pharmacokinetics, especially the systemic availability of THC after vaporised administration, is unknown.
AIMS


To investigate the influence of different doses of co-administered CBD on the systemic availability of THC, and to compare the availability of THC and CBD in a sample of frequent and infrequent cannabis users.
METHODS


The study used a randomised, double-blind, crossover placebo-controlled design. THC and/or CBD in ethanol was vaporised and inhaled. Plasma concentrations of THC and CBD were analysed. The THC data created in this study were pooled together with published THC pharmacokinetic data in order to cover all the phases of THC disposition. Population pharmacokinetic model of THC was developed based on the pooled data. The model of CBD was developed based on the data created in this study.
RESULTS


Population pharmacokinetic models of THC and CBD were developed. With concomitant inhalation of high-dose CBD, the systemic availability of THC decreased significantly. Frequent cannabis users appeared to have higher systemic availability of THC and CBD when high-dose CBD was administered.
CONCLUSIONS


The results observed in this study are useful for guiding future pharmacokinetic studies of medicinal cannabinoids, and for development of dosing guidelines for medical use of cannabis in the 'real-world' setting.",2020,"Frequent cannabis users appeared to have higher systemic availability of THC and CBD when high dose CBD was administered.
",[],"['placebo', 'THC', 'coadministered CBD', 'tetrahydrocannabinol']","['Plasma concentrations of THC and CBD', 'systemic availability of THC and CBD', 'systemic availability of THC', 'availability of THC and CBD', 'THC) and cannabidiol (CBD']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]",,0.0941398,"Frequent cannabis users appeared to have higher systemic availability of THC and CBD when high dose CBD was administered.
","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Galettis', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Broyd', 'Affiliation': 'School of Psychology and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Hendrika', 'Initials': 'H', 'LastName': 'van Hell', 'Affiliation': 'School of Psychology and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Lisa-Marie', 'Initials': 'LM', 'LastName': 'Greenwood', 'Affiliation': 'School of Psychology and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Krey', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Solowij', 'Affiliation': 'The Australian Centre for Cannabinoid Clinical and Research Excellence, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Martin', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}]",Internal medicine journal,['10.1111/imj.14415']
914,31255371,"A Low-Cost, Intradialytic, Protein-Rich Meal Improves the Nutritional Status in Chinese Hemodialysis Patients.","OBJECTIVE


Short-term administration of oral nutritional supplements can improve the nutritional status of hemodialysis patients. However, such treatment is associated with high cost. The aim of the present trial was to evaluate the benefits of the short-term administration of a low-cost, intradialytic, protein-rich meal on selected parameters of the nutritional status in Chinese patients undergoing hemodialysis.
METHODS


This was a 6-month single-center, prospective interventional study. Stable hemodialysis patients aged ≥18 years with a concentration of serum albumin <40 g/L were eligible for inclusion in this study. Patients allocated to the intervention group (IG) received nutritional counseling plus a low-cost, intradialytic, protein-rich meal thrice weekly over a period of 3 months, followed by a treatment-free period of 3 months. Patients allocated to the control group (CG) received nutritional counseling alone. Changes in serum albumin and body composition were investigated.
RESULTS


At the start of the study, both groups were similar except for the levels of C-reactive protein (P = .034) and hemoglobin (P = .003). At the end of the study period, the level of serum albumin (P = .001) was significantly increased with increased protein intake in the IG (P = .048). However, this difference was not sustained during the follow-up period after termination of therapy. In the IG, the levels of serum albumin were significantly decreased between months 3 and 6 (P < .001), whereas those in the CG remained unchanged. There were no statistically significant differences observed between the two groups in the levels of C-reactive protein and body composition.
CONCLUSION


The short-term administration of a low-cost, intradialytic, protein-rich meal (i.e., 200 mL milk plus two egg whites) resulted in a significant improvement in the levels of serum albumin versus nutritional counseling alone. This inexpensive nutritional intervention was feasible for the treatment of Chinese patients undergoing hemodialysis.",2020,"At the end of the study period, the level of serum albumin (P = .001) was significantly increased with increased protein intake in the IG (P = .048).","['hemodialysis patients', 'Chinese Hemodialysis Patients', 'Stable hemodialysis patients aged ≥18 years with a concentration of serum albumin <40 g/L were eligible for inclusion in this study', 'Chinese patients undergoing hemodialysis']","['nutritional counseling plus a low-cost, intradialytic, protein-rich meal thrice', 'oral nutritional supplements', 'control group (CG) received nutritional counseling alone', 'inexpensive nutritional intervention', 'low-cost, intradialytic, protein-rich meal']","['levels of C-reactive protein', 'serum albumin and body composition', 'hemoglobin', 'levels of serum albumin', 'level of serum albumin', 'protein intake', 'levels of C-reactive protein and body composition']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444661', 'cui_str': 'Protein-rich meal (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.0151238,"At the end of the study period, the level of serum albumin (P = .001) was significantly increased with increased protein intake in the IG (P = .048).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Division of Neurology, Baotou Central Hospital, Baotou, China.'}, {'ForeName': 'Guocun', 'Initials': 'G', 'LastName': 'Hou', 'Affiliation': 'Division of Nephrology, Baotou Central Hospital, Baotou, China. Electronic address: houguocun2007@163.com.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Division of Nephrology, Baotou Central Hospital, Baotou, China.'}, {'ForeName': 'Aizhen', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Division of Nephrology, Baotou Central Hospital, Baotou, China.'}, {'ForeName': 'Yuanmin', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Division of Nephrology, Baotou Central Hospital, Baotou, China.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.03.084']
915,32005839,Preventing peripheral intravenous catheter failure by reducing mechanical irritation.,"Peripheral intravenous catheter failure is a significant concern in the clinical setting. We investigated the effectiveness of care protocols, including an ultrasonographic ""pre-scan"" for selecting a large-diameter vein before catheterization, a ""post-scan"" for confirming the catheter tip position after catheterization with ultrasonography, and the use of a flexible polyurethane catheter to reduce the mechanical irritation that contributes to the incidence of catheter failure. This intervention study was a non-randomized controlled trial to investigate the effectiveness of the abovementioned care protocols, the effects of which were compared to the outcomes in the control group, which received conventional care. For both groups, participants were selected from patients in two wards at the University of Tokyo in Japan between July and November 2017. Inverse probability score-based weighted methods (IPW) using propensity score were used to estimate the effectiveness of care protocols. The primary outcome was catheter failure, which was defined as accidental and unplanned catheter removal. We used Kaplan-Meier survival curves to compare rates of time until catheter failure. We analysed 189 and 233 catheters in the intervention and control groups, respectively. In the control group, 68 catheters (29.2%) were determined to have failed, whereas, in the intervention group, only 21 catheters (11.1%) failed. There was a significant difference between each group regarding the ratio of catheter failure adjusted according to IPW (p = 0.003). The relative risk reduction of the intervention for catheter failure was 0.60 (95% CI: 0.47-0.71). Care protocols, including assessment of vein diameter, vein depth, and catheter tip location using ultrasound examination for reducing mechanical irritation is a promising method to reduce catheter failure incidence.",2020,The relative risk reduction of the intervention for catheter failure was 0.60 (95% CI: 0.47-0.71).,['participants were selected from patients in two wards at the University of Tokyo in Japan between July and November 2017'],['conventional care'],"['catheter failure, which was defined as accidental and unplanned catheter removal', 'relative risk reduction', 'catheter failure', 'ratio of catheter failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0517604,The relative risk reduction of the intervention for catheter failure was 0.60 (95% CI: 0.47-0.71).,"[{'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Life Support Technology (Molten), Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Murayama', 'Affiliation': 'Department of Advanced Nursing Technology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Abe-Doi', 'Affiliation': 'Department of Advanced Nursing Technology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Miyahara-Kaneko', 'Affiliation': 'Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Kanno', 'Affiliation': 'Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Nursing, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Mizuno', 'Affiliation': 'Department of Nursing, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Chieko', 'Initials': 'C', 'LastName': 'Komiyama', 'Affiliation': 'Department of Nursing, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Sanada', 'Affiliation': 'Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. hsanada-tky@umin.ac.jp.'}]",Scientific reports,['10.1038/s41598-019-56873-2']
916,31264055,Pilot randomized controlled trial of exercise training for older veterans with PTSD.,"Exercise training positively impacts mental health, yet remains untested in older adults with posttraumatic stress disorder (PTSD). We conducted a randomized controlled pilot trial to test the feasibility and acceptability of exercise training in older veterans with PTSD. Fifty-four veterans ≥ 60 years, with a DSM-V diagnosis of PTSD, were randomized to supervised exercise (n = 36) or wait-list (WL; n = 18). Primary outcomes included recruitment rates, attendance, satisfaction, and retention. Secondary outcomes included changes in PTSD symptoms, depression, health-related quality of life, and sleep quality; assessed at baseline and 12 weeks. There were no adverse events. Attrition was minimal (14%), and adherence to the exercise intervention was high (82%). Clinically significant improvements in PTSD and related conditions were observed following exercise (Cohen's d = 0.36-0.81). Exercise training is safe and acceptable in older adults with PTSD, may improve PTSD symptoms, and broadly impacts PTSD-related conditions. Future definitive trials are warranted.",2020,Clinically significant improvements in PTSD and related conditions were observed following exercise (Cohen's d = 0.36-0.81).,"['60\xa0years, with a DSM-V diagnosis of PTSD', 'Fifty-four veterans ≥', 'older veterans with PTSD', 'older adults with PTSD', 'older adults with posttraumatic stress disorder (PTSD']","['exercise training', 'supervised exercise', 'Exercise training']","['PTSD and related conditions', 'recruitment rates, attendance, satisfaction, and retention', 'Attrition', 'changes in PTSD symptoms, depression, health-related quality of life, and sleep quality']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0384691,Clinically significant improvements in PTSD and related conditions were observed following exercise (Cohen's d = 0.36-0.81).,"[{'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Hall', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Durham Healthcare System, 508 Fulton St., Durham, NC, 27705, USA. katherine.hall@duke.edu.'}, {'ForeName': 'Miriam C', 'Initials': 'MC', 'LastName': 'Morey', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Durham Healthcare System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Medicine, Duke University, 3600 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center, VA Durham Healthcare System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Pebole', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Durham Healthcare System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sloane', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Durham Healthcare System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, 3600 Duke Medicine Circle, Durham, NC, 27710, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00073-w']
917,31277968,Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial.,"INTRODUCTION


Despite the importance of using penile injections as part of a penile rehabilitation program, men have difficulty complying with these programs.
AIM


To test a novel psychological intervention based on Acceptance and Commitment Therapy for erectile dysfunction (ACT-ED) to help men utilize penile injections.
METHODS


This pilot randomized controlled trial (RCT) recruited men who were beginning a standard care (SC) structured penile rehabilitation program following radical prostatectomy. The SC program instructed patients to use penile injections 2 to 3 times per week. Participants were randomized to SC+ACT-ED or SC+enhanced monitoring (EM). Over 4 months, patients in the SC+ACT-ED group received SC plus 4 ACT sessions and 3 ACT phone calls; those in the EM group received SC plus 7 phone calls from an experienced sexual medicine nurse practitioner. Participants were assessed at study entry and at 4 and 8 months. For this pilot study, the goal was to determine initial efficacy (ie, effect sizes, where d = 0.2 is small, d = 0.5 is medium, and d = 0.8 is large).
MAIN OUTCOME MEASURE


Primary outcomes were feasibility and use of penile injections. Secondary outcomes were ED treatment satisfaction (ie, Erectile Dysfunction Inventory of Treatment Satisfaction, or EDITS), sexual Self-Esteem and Relationship (SEAR) quality, sexual bother (SB), and prostate cancer treatment regret.
RESULTS


The 53 participants were randomized (ACT, n = 26; EM, n = 27). The study acceptance rate was 61%. At 4 months, the ACT-ED group utilized more penile injections per week (1.7) compared to the EM group (0.9) (d = 1.25; P = .001) and was more adherent to penile rehabilitation compared to the EM group (ACT, 44%; EM, 10%; relative risk [RR], 4.4; P = .02). These gains were maintained at 8 months for injections per week (ACT, 1.2; EM, 0.7; d = 1.08; P = .03) and approached significance for adherence (ACT, 18%; EM, 0%; P = .10). At 4 months, ACT-ED, compared to EM, reported moderate effects for greater satisfaction with ED treatment (d = 0.41; P = .22), greater sexual self-esteem (d = 0.54; P = .07) and sexual confidence (d = 0.48; P = .07), lower sexual bother (d = 0.43; P = .17), and lower prostate cancer treatment regret (d = 0.74; P = .02). At 8 months, moderate effects in favor of ACT-ED were maintained for greater sexual self-esteem (d = 0.40; P = .19) and less treatment regret (d = 0.47; P = .16).
CLINICAL IMPLICATIONS


ACT concepts may help men utilize penile injections and cope with the effects of ED.
STRENGTHS AND LIMITATIONS


Strengths include use of an innovative intervention utilizing ACT concepts and pilot RCT. Limitations include the pilot nature of the study (eg, small samples size, lack of statistical power).
CONCLUSION


ACT-ED is feasible and significantly increases the use of penile injections. ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret. Nelson CJ, Saracino RM, Napolitano S, et al. Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial. J Sex Med 2019; 19:1398-1408.",2019,ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret.,['53 participants'],"['standard care (SC) structured penile rehabilitation program following radical prostatectomy', 'Penile Injection Therapy-Based Rehabilitation', 'novel psychological intervention based on Acceptance and Commitment Therapy', 'SC+ACT-ED or SC+enhanced monitoring (EM']","['acceptance rate', 'ED treatment satisfaction (ie, Erectile Dysfunction Inventory of Treatment Satisfaction, or EDITS), sexual Self-Esteem and Relationship (SEAR) quality, sexual bother (SB), and prostate cancer treatment regret', 'lower prostate cancer treatment regret', 'treatment regret', 'adherent to penile rehabilitation', 'initial efficacy', 'sexual confidence', 'lower sexual bother', 'feasibility and use of penile injections', 'sexual self-esteem', 'greater sexual self-esteem']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",53.0,0.0701759,ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret.,"[{'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Electronic address: nelsonc@mskcc.org.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Saracino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Napolitano', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Pessin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Narus', 'Affiliation': 'Sexual and Reproductive Medicine Program, Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Mulhall', 'Affiliation': 'Sexual and Reproductive Medicine Program, Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.013']
918,32409778,A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial.,"STUDY DESIGN


Protocol for a pragmatic randomized controlled trial (the Exercise guideline Promotion and Implementation in Chronic SCI [EPIC-SCI] Trial).
PRIMARY OBJECTIVES


To test if home-/community-based exercise, prescribed according to the international SCI exercise guidelines, significantly reduces chronic bodily pain in adults with SCI.
SECONDARY OBJECTIVES


To investigate: (1) the effects of exercise on musculoskeletal and neuropathic chronic pain; (2) if reduced inflammation and increased descending inhibitory control are viable pathways by which exercise reduces pain; (3) the effects of chronic pain reductions on subjective well-being; and (4) efficiency of a home-/community-based exercise intervention.
SETTING


Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada.
METHOD


Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines, will be recruited and randomized to a 6-month Exercise or Wait-List Control condition. Exercise will occur in home/community settings and will be supported through behavioral counseling. All measures will be taken at baseline, 3-months and 6-months. Analyses will consist of linear mixed effect models, multiple regression analyses and a cost-utility analysis. The economic evaluation will examine the incremental costs and health benefits generated by the intervention compared with usual care.
ETHICS AND DISSEMINATION


The University of British Columbia Clinical Research Ethics Board approved the protocol (#H19-01650). Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.",2020,"Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.","['adults with SCI', 'Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada', 'Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines']","['home-/community-based exercise intervention', 'international scientific SCI exercise guidelines', '6-month Exercise or Wait-List Control condition', 'exercise']","['chronic bodily pain', 'musculoskeletal and neuropathic chronic pain', 'SCI chronic pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",84.0,0.155033,"Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.","[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada. kathleen_martin.ginis@ubc.ca.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'van der Scheer', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kendra R', 'Initials': 'KR', 'LastName': 'Todd', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Centre for Chronic Disease Prevention and Management, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gaudet', 'Affiliation': 'Spinal Cord Injury British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Hoekstra', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Mohammad Ehsanul', 'Initials': 'ME', 'LastName': 'Karim', 'Affiliation': 'School of Population and Public Health and Centre for Health Evaluation and Outcome Sciences, Providence Health Care, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John L K', 'Initials': 'JLK', 'LastName': 'Kramer', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, UBC; Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Townson', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}]",Spinal cord,['10.1038/s41393-020-0478-7']
919,31023843,"The effect of gefapixant, a P2X3 antagonist, on cough reflex sensitivity: a randomised placebo-controlled study.","We evaluated the effect of gefapixant on cough reflex sensitivity to evoked tussive challenge.In this phase 2, double-blind, two-period study, patients with chronic cough (CC) and healthy volunteers (HV) were randomised to single-dose gefapixant 100 mg or placebo in a crossover fashion. Sequential inhalational challenges with ATP, citric acid, capsaicin and distilled water were performed 1, 3 and 5 h after dosing. Mean concentrations evoking ≥2 coughs (C2) and ≥5 coughs (C5) post dose  versus  baseline were co-primary endpoints. Objective cough frequency (coughs·h -1 ) over 24 h and a cough severity visual analogue scale (VAS) were assessed in CC patients. Adverse events were monitored.24 CC patients and 12 HV were randomised (mean age 61 and 38 years, respectively). The cough challenge threshold increased for ATP by 4.7-fold (C2, p≤0.001) and 3.7-fold (C5, p=0.007) for gefapixant  versus  placebo in CC patients; in HV, C2 and C5 increased 2.4-fold (C2, p=0.113; C5, p=0.003). The distilled water C2 and C5 thresholds increased significantly (p<0.001) by a factor of 1.4 and 1.3, respectively, in CC patients. Gefapixant had no effect on capsaicin or citric acid challenge. Median cough frequency was reduced by 42% and the least squares mean cough severity VAS was 18.0 mm lower for gefapixant  versus  placebo in CC patients. Dysgeusia was the most frequent adverse event (75% of HV and 67% of CC patients).ATP-evoked cough was significantly inhibited by gefapixant 100 mg, demonstrating peripheral target engagement. Cough count and severity were reduced in CC patients. Distilled water may also evoke cough through a purinergic pathway.",2019,"The cough challenge threshold increased for ATP by 4.7-fold (C2, p≤0.001) and 3.7-fold (C5, p=0.007) for gefapixant  versus  placebo in CC patients; in HV, C2 and C5 increased 2.4-fold (C2, p=0.113; C5, p=0.003).",['patients with chronic cough (CC) and healthy volunteers (HV'],"['placebo', 'gefapixant, a P2X3 antagonist', 'ATP, citric acid, capsaicin and distilled water', 'gefapixant', 'gefapixant 100\u2005mg or placebo']","['Mean concentrations evoking ≥2 coughs (C2) and ≥5 coughs (C5', 'Dysgeusia', 'Adverse events', 'Cough count and severity', 'Objective cough frequency (coughs·h -1 ) over 24\u2005h and a cough severity visual analogue scale (VAS', 'capsaicin or citric acid challenge', 'evoked cough', 'cough reflex sensitivity', 'Median cough frequency', 'cough severity VAS', 'cough challenge threshold increased for ATP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex (observable entity)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001480', 'cui_str': 'ATP'}]",,0.0679462,"The cough challenge threshold increased for ATP by 4.7-fold (C2, p≤0.001) and 3.7-fold (C5, p=0.007) for gefapixant  versus  placebo in CC patients; in HV, C2 and C5 increased 2.4-fold (C2, p=0.113; C5, p=0.003).","[{'ForeName': 'Alyn H', 'Initials': 'AH', 'LastName': 'Morice', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tershakovec', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Brindle', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Thackray-Nocera', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}]",The European respiratory journal,['10.1183/13993003.00439-2019']
920,30914268,A randomised controlled trial of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDITOF-MS) versus conventional microbiological methods for identifying pathogens: Impact on optimal antimicrobial therapy of invasive bacterial and fungal infections in Vietnam.,"OBJECTIVES


We assessed the impact of MALDITOF-MS on the timeliness of optimal antimicrobial therapy through a parallel-arm randomised controlled trial in two hospitals in Vietnam.
METHODS


We recruited patients with a pathogen (bacterial or fungal) cultured from a normally sterile sample. Samples were randomly assigned (1:1) to identification by MALDITOF-MS or conventional diagnostics. The primary outcome was the proportion on optimal antimicrobial therapy within 24 h of positive culture, determined by a blinded independent review committee. Trial registered at ClinicalTrials.gov (NCT02306330).
RESULTS


Among 1005 randomised patients, pathogens were isolated from 628 (326 intervention, 302 control), with 377 excluded as likely contaminants or discharged/died before positive culture. Most isolates were cultured from blood (421/628, 67.0%). The proportion receiving optimal antimicrobial therapy within 24 h (the primary outcome) or 48 h of growth was not significantly different between MALDITOF-MS and control arms (135/326, 41.4% vs 120/302, 39.7%; Adjusted Odds ration (AOR) 1.17, p = 0.40 and 151/326, 46.3% vs 141/302, 46.7%; AOR 1.05 p = 0.79, respectively).
CONCLUSIONS


MALDITOF-MS, in the absence of an antimicrobial stewardship programme, did not improve the proportion on optimal antimicrobial therapy at 24 or 48 h after first growth in a lower-middle income setting with high rates of antibiotic resistance.",2019,"The proportion receiving optimal antimicrobial therapy within 24 h (the primary outcome) or 48 h of growth was not significantly different between MALDITOF-MS and control arms (135/326, 41.4% vs 120/302, 39.7%; Adjusted Odds ration (AOR) 1.17, p = 0.40 and 151/326, 46.3% vs 141/302, 46.7%; AOR 1.05 p = 0.79, respectively).
","['two hospitals in Vietnam', '1005 randomised patients, pathogens were isolated from 628 (326 intervention, 302 control), with 377 excluded as likely contaminants or discharged/died before positive culture', 'invasive bacterial and fungal infections in Vietnam', 'patients with a pathogen (bacterial or fungal) cultured from a normally sterile sample', 'identifying pathogens']",['matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDITOF-MS) versus conventional microbiological methods'],"['proportion on optimal antimicrobial therapy within 24\u202fh of positive culture', '48\u202fh of growth']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0026946', 'cui_str': 'Fungal Infections'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0037813', 'cui_str': 'Spectrum Analysis, Mass'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0450078', 'cui_str': 'Microbiological method (qualifier value)'}]","[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",1005.0,0.306059,"The proportion receiving optimal antimicrobial therapy within 24 h (the primary outcome) or 48 h of growth was not significantly different between MALDITOF-MS and control arms (135/326, 41.4% vs 120/302, 39.7%; Adjusted Odds ration (AOR) 1.17, p = 0.40 and 151/326, 46.3% vs 141/302, 46.7%; AOR 1.05 p = 0.79, respectively).
","[{'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Nadjm', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam; Centre for Tropical Medicine & Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: bnadjm@oucru.org.'}, {'ForeName': 'Vu Quoc', 'Initials': 'VQ', 'LastName': 'Dat', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam; Department of Infectious Diseases, Hanoi Medical University, Hanoi, Viet Nam.'}, {'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Campbell', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam; Centre for Tropical Medicine & Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Vu Tien Viet', 'Initials': 'VTV', 'LastName': 'Dung', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Torre', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Thi Cam', 'Initials': 'NTC', 'LastName': 'Tu', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ninh Thi Thanh', 'Initials': 'NTT', 'LastName': 'Van', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Dao Tuyet', 'Initials': 'DT', 'LastName': 'Trinh', 'Affiliation': 'National Hospital for Tropical Diseases, Hanoi, Viet Nam.'}, {'ForeName': 'Nguyen Phu Huong', 'Initials': 'NPH', 'LastName': 'Lan', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Vu', 'Initials': 'NV', 'LastName': 'Trung', 'Affiliation': 'National Hospital for Tropical Diseases, Hanoi, Viet Nam.'}, {'ForeName': 'Nguyen Thi Thuy', 'Initials': 'NTT', 'LastName': 'Hang', 'Affiliation': 'National Hospital for Tropical Diseases, Hanoi, Viet Nam.'}, {'ForeName': 'Le Thi', 'Initials': 'LT', 'LastName': 'Hoi', 'Affiliation': 'National Hospital for Tropical Diseases, Hanoi, Viet Nam.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam; Centre for Tropical Medicine & Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Wolbers', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Van Kinh', 'Affiliation': 'National Hospital for Tropical Diseases, Hanoi, Viet Nam.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam; Centre for Tropical Medicine & Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'H Rogier', 'Initials': 'HR', 'LastName': 'van Doorn', 'Affiliation': 'Oxford University Clinical Research Unit, Hanoi & Ho Chi Minh City, Viet Nam; Centre for Tropical Medicine & Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Heiman F L', 'Initials': 'HFL', 'LastName': 'Wertheim', 'Affiliation': 'Centre for Tropical Medicine & Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Department of Medical Microbiology, RadboudUMC, Nijmegen, The Netherlands.'}]",The Journal of infection,['10.1016/j.jinf.2019.03.010']
921,31733423,"Effects of teriparatide versus percutaneous vertebroplasty on pain relief, quality of life and cost-effectiveness in postmenopausal females with acute osteoporotic vertebral compression fracture: A prospective cohort study.","BACKGROUND


Osteoporotic vertebral compression fracture (OVCF) is a common disease in senior patients. Conservative treatments (usual care) and percutaneous vertebroplasty (PVP) are typically applied to treat OVCFs; however, their efficacies are not fully satisfactory. While Teriparatide (TPTD) is effective in both anti-osteoporosis and bone healing, whether TPTD could be applied as a conservative treatment for acute OVCFs remains unclear.
METHODS


This investigation represents a real-world prospective cohort study, where 60 postmenopausal women (≥55 years old) with acute OVCFs were equally assigned to a TPTD conservative group or PVP (plus alendronate) group based on the patient's choice. TPTD (20 μg, s.c., once daily) or alendronate (70 mg, p.o., once weekly) were administrated together with 0.6 mg Caltrate and 500 iu Vitamin D3 per day. A health survey (SF-36) was conducted at 0-, 1- and 3-months post-treatment. Back pain and the Oswestry Disability Index (ODI) were measured at 0-week, 1-week, 1-month and 3-months after treatment, while the direct medical cost was analyzed at the end of the third month.
RESULTS


Both treatments with TPTD and PVP significantly and similarly improved the patients' health quality, with reduced visual analogue and ODI scores at the end of the first and third months. PVP was more effective in reducing pain at the early time point (1 week, p < 0.05). 24 of 27 patients who were rescanned with magnetic resonance imaging in the TPTD group showed bone healing. The mid-vertebral height was increased by PVP (p < 0.05) but not by TPTD. The cost of TPTD treatment was 21,868.61 ± 167.05 RMB per capita, while the cost for PVP treatment was 33,265.95 ± 1491.11 RMB per capita (p < 0.05).
CONCLUSION


TPTD conservative treatment obtained similar therapeutic effects but cost less than PVP in terms of treating acute OVCF.",2020,"PVP was more effective in reducing pain at the early time point (1 week, p < 0.05).","['60 postmenopausal women (≥55\u202fyears old) with acute OVCFs', 'senior patients', 'postmenopausal females with acute osteoporotic vertebral compression fracture', '24 of 27 patients who were rescanned with magnetic resonance imaging in the']","['Teriparatide (TPTD', 'TPTD and PVP', 'TPTD', 'teriparatide', 'percutaneous vertebroplasty', 'TPTD conservative group or PVP (plus alendronate', 'Conservative treatments (usual care) and percutaneous vertebroplasty (PVP', 'PVP', 'alendronate', 'Osteoporotic vertebral compression fracture (OVCF']","['mid-vertebral height', 'direct medical cost', 'cost of TPTD treatment', ""patients' health quality"", 'pain relief, quality of life and cost-effectiveness', 'pain', 'Back pain and the Oswestry Disability Index (ODI', 'visual analogue and ODI scores', 'bone healing']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",60.0,0.0246109,"PVP was more effective in reducing pain at the early time point (1 week, p < 0.05).","[{'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Spine Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Spine Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Spine Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Spine Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Spine Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianting', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Spine Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China. Electronic address: drmyang@yahoo.com.'}]",Bone,['10.1016/j.bone.2019.115154']
922,31798984,"Effectiveness of a multilevel intervention to reduce violence and increase condom use in intimate partnerships among female sex workers: cluster randomised controlled trial in Karnataka, India.","Introduction


Samvedana Plus is a multilevel intervention working with sex workers, their intimate partners (IPs) and communities to reduce intimate partner violence (IPV) and to increase condom use within intimate relationships of sex workers in Northern Karnataka, India.
Methods


A cluster randomised controlled trial in 47 villages. Female sex workers with IPs in the last 6 months were eligible for baseline (2014), midline (2016) and endline (2017) surveys. 24 villages were randomised to Samvedana Plus and 23 to a wait-list control. Primary outcomes among sex workers included experience of physical and/or sexual IPV or severe physical/sexual IPV in the last 6 months and consistent condom use with their IP in past 30 days. Analyses adjusted for clustering and baseline cluster-level means of outcomes.
Result


Baseline (n=620) imbalance was observed with respect to age (33.9 vs 35.2) and IPV (31.4% vs 45.0%). No differences in physical/sexual IPV (8.1% vs 9.0%), severe physical/sexual IPV (6.9% vs 8.7%) or consistent condom use with IPs (62.5% vs 57.3%) were observed by trial arm at end line (n=547). Samvedana Plus was associated with decreased acceptance of IPV (adjusted OR (AOR)=0.62, 95% CI 0.40 to 0.94, p=0.025), increased awareness of self-protection strategies (AOR=1.73, 95% CI=1.04-2.89, p=0.035) and solidarity of sex workers around issues of IPV (AOR=1.69, 95% CI=1.02-2.82, p=0.042). We observed an increase in IPV between baseline (25.9%) and midline (63.5%) among women in Samvedana Plus villages but lower in comparison villages (41.8%-44.3%) and a sharp decrease at end line in both arms (~8%).
Conclusion


We found no evidence that Samvedana Plus reduced IPV or increased condom use, but it may impact acceptance of IPV, increase knowledge of self-protection strategies and increase sex worker solidarity. Inconsistencies in reported IPV undermined the ability of the trial to assess effectiveness.
Trial registration number


NCT02807259.",2019,"Plus was associated with decreased acceptance of IPV (adjusted OR (AOR)=0.62, 95% CI 0.40 to 0.94, p=0.025), increased awareness of self-protection strategies (AOR=1.73, 95% CI=1.04-2.89, p=0.035) and solidarity of sex workers around issues of IPV (AOR=1.69, 95% CI=1.02-2.82, p=0.042).","['24 villages', 'Female sex workers with IPs in the last 6 months were eligible for baseline (2014), midline (2016) and endline (2017) surveys', 'sex workers in Northern Karnataka, India', 'female sex workers', '47 villages']","['Introduction\n\n\nSamvedana', 'Samvedana', 'multilevel intervention', 'Samvedana Plus and 23 to a wait-list control']","['awareness of self-protection strategies', 'solidarity of sex workers around issues of IPV', 'IPV', 'severe physical/sexual IPV', 'acceptance of IPV', 'physical/sexual IPV', 'experience of physical and/or sexual IPV or severe physical/sexual IPV']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0240816', 'cui_str': 'Prostitutes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3146223', 'cui_str': 'Awareness of self (observable entity)'}, {'cui': 'C0240816', 'cui_str': 'Prostitutes'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",,0.190348,"Plus was associated with decreased acceptance of IPV (adjusted OR (AOR)=0.62, 95% CI 0.40 to 0.94, p=0.025), increased awareness of self-protection strategies (AOR=1.73, 95% CI=1.04-2.89, p=0.035) and solidarity of sex workers around issues of IPV (AOR=1.69, 95% CI=1.02-2.82, p=0.042).","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Javalkar', 'Affiliation': 'Karnataka Health Promotion Trust, Bengalaru, India.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Platt', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Prakash', 'Affiliation': 'Karnataka Health Promotion Trust, Bengalaru, India.'}, {'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Beattie', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Collumbien', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Mitzy', 'Initials': 'M', 'LastName': 'Gafos', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Satyanarayana', 'Initials': 'S', 'LastName': 'Ramanaik', 'Affiliation': 'Karnataka Health Promotion Trust, Bengalaru, India.'}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Davey', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Division, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Parinita', 'Initials': 'P', 'LastName': 'Bhattacharjee', 'Affiliation': 'Karnataka Health Promotion Trust, Bengalaru, India.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Thalinja', 'Affiliation': 'Karnataka Health Promotion Trust, Bengalaru, India.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Dl', 'Affiliation': 'Karnataka Health Promotion Trust, Bengalaru, India.'}, {'ForeName': 'Shajy', 'Initials': 'S', 'LastName': 'Isac', 'Affiliation': 'Karnataka Health Promotion Trust, Bengalaru, India.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Heise', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ global health,['10.1136/bmjgh-2019-001546']
923,30808389,Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial.,"BACKGROUND


Adolescence and young adulthood are critical times of initiation and progression to daily use of tobacco. However, it is difficult to recruit young adults to traditional smoking cessation and retention rates are typically low. Smartphone cessation applications (apps) can provide real-time responses to smoking urges and related cues, which are known to be important factors in lapse and relapse. Given the popularity of smartphones among young adults and the considerably higher download rates of commercially developed apps compared to research-based apps, there is a need to design pragmatic studies that evaluate commercial tobacco cessation apps. The aims of this pilot study are to assess the impact on tobacco cessation of using a smartphone app compared with usual care and to generate feasibility data to inform a future fully powered clinical trial.
METHODS


We will conduct an open randomized controlled trial with parallel groups. Participants will be selected from hospitalized patients and must be aged 18-30 years, interested in cessation, smoked > 5 cigarettes/day over the past 30 days, and own an Apple or Android smartphone. Participants who are eligible will be randomized to either a smartphone experimental group or patient-initiated follow up (usual care). As this study seeks to assess feasibility, the primary data will include (1) recruitment rates, (2) retention rates, and (3) adherence, measured through user engagement with the app.
DISCUSSION


This pilot trial will be the first to evaluate a commercially available smartphone app for tobacco cessation in a hospitalized setting. Data generated by this study can be used for larger fully powered trials such as comparative effectiveness studies against apps developed by academics or health scientists based on behavioral theories, or cost-effectiveness analyses of mobile interventions.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03538678 . Registered on 28 May 2018.",2019,"Smartphone cessation applications (apps) can provide real-time responses to smoking urges and related cues, which are known to be important factors in lapse and relapse.","['Participants will be selected from hospitalized patients and must be aged 18-30\u2009years, interested in cessation, smoked >\u20095 cigarettes/day over the past 30\u2009days, and own an Apple or Android smartphone', 'young adults']","['smartphone app compared with usual care', 'Tobacco cessation mobile app intervention', 'smartphone experimental group or patient-initiated follow up (usual care']","['recruitment rates, (2) retention rates, and (3) adherence, measured through user engagement with the app']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0718532', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.189761,"Smartphone cessation applications (apps) can provide real-time responses to smoking urges and related cues, which are known to be important factors in lapse and relapse.","[{'ForeName': 'Kar-Hai', 'Initials': 'KH', 'LastName': 'Chu', 'Affiliation': 'University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA. chuk@pitt.edu.'}, {'ForeName': 'César G', 'Initials': 'CG', 'LastName': 'Escobar-Viera', 'Affiliation': 'University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Matheny', 'Affiliation': 'University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Esa M', 'Initials': 'EM', 'LastName': 'Davis', 'Affiliation': 'University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Primack', 'Affiliation': 'University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA.'}]",Trials,['10.1186/s13063-019-3246-2']
924,31240665,"Comparative study of the influence of adductor canal block plus multimodal periarticular infiltration versus combined adductor canal block, multimodal periarticular infiltration and intra-articular epidural catheter ropivacaine infiltration on pain relief after total knee arthroplasty: a prospective study.","BACKGROUND


A combined regimen of adductor canal block (ACB) and multimodal periarticular infiltration (MPI) with local anesthetic (ropivacaine) is a known effective method of controlling pain in the first 6-8 h after total knee arthroplasty (TKA); however, managing breakthrough pain after their combined effect wears off can be challenging. We hypothesized that, by additionally leaving an intra-articular epidural catheter (IAEC) inside the knee with intermittent infiltration of local anesthetic in conjunction with ACB and MPI, it would help manage the breakthrough pain when their combined effect wears off.
METHODS


We did a prospective study in our institution between December 2015 and August 2016 on a total of 206 patients undergoing primary unilateral TKA. The initial consecutive 106 patients received ACB + MPI (Group 1, n = 106), and the subsequent 100 patients received ACB + MPI + IAEC (Group 2, n = 100). The primary outcome measure was pain using visual analogue scale (VAS) recorded at 6, 12, 24 and 48 h, and the secondary outcome measures were requirement for rescue analgesics and repeat adductor canal block and length of hospital stay.
RESULTS


There was no statistically significant difference in VAS scores between the two groups at 6 h but at 12, 24 and 48 h; there was a statistically significant difference between the two groups in terms of VAS scores, rescue analgesic requirements, repeat adductor canal block and shorter hospital stay favoring the ACB + MPI + IAEC group.
CONCLUSION


Intermittent knee infiltration with ropivacaine is a safe, reproducible and effective method to control pain in the first 48 h postoperative period after TKA.",2020,"There was no statistically significant difference in VAS scores between the two groups at 6 h but at 12, 24 and 48 h; there was a statistically significant difference between the two groups in terms of VAS scores, rescue analgesic requirements, repeat adductor canal block and shorter hospital stay favoring the ACB + MPI + IAEC group.
","['after total knee arthroplasty', 'our institution between December 2015 and August 2016 on a total of 206 patients undergoing primary unilateral TKA']","['ACB\u2009+\u2009MPI', 'adductor canal block plus multimodal periarticular infiltration versus combined adductor canal block, multimodal periarticular infiltration and intra-articular epidural catheter ropivacaine infiltration', 'adductor canal block (ACB) and multimodal periarticular infiltration (MPI) with local anesthetic (ropivacaine', 'ropivacaine', 'ACB\u2009+\u2009MPI\u2009+\u2009IAEC']","['VAS scores, rescue analgesic requirements, repeat adductor canal block and shorter hospital stay', 'pain using visual analogue scale (VAS', 'VAS scores', 'requirement for rescue analgesics and repeat adductor canal block and length of hospital stay', 'pain relief']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter, device (physical object)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",206.0,0.0581146,"There was no statistically significant difference in VAS scores between the two groups at 6 h but at 12, 24 and 48 h; there was a statistically significant difference between the two groups in terms of VAS scores, rescue analgesic requirements, repeat adductor canal block and shorter hospital stay favoring the ACB + MPI + IAEC group.
","[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Dannana', 'Affiliation': 'Max Cure Hospital, Hyderabad, India. sekhardannana@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Apsingi', 'Affiliation': 'Max Cure Hospital, Hyderabad, India.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Ponnala', 'Affiliation': 'Max Cure Hospital, Hyderabad, India.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Bollavaram', 'Affiliation': 'Max Cure Hospital, Hyderabad, India.'}, {'ForeName': 'Giridhar', 'Initials': 'G', 'LastName': 'Boyapati', 'Affiliation': 'Max Cure Hospital, Hyderabad, India.'}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Eachempati', 'Affiliation': 'Max Cure Hospital, Hyderabad, India.'}]",Musculoskeletal surgery,['10.1007/s12306-019-00613-2']
925,31186395,Clinical application of percutaneous kyphoplasty under the guidance of DynaCT in the treatment of compression fractures of thoracolumbar.,"OBJECTIVES


This study aims to investigate the clinical application values of percutaneous kyphoplasty (PKP) under the guidance of DynaCT in the treatment of compression fractures of thoracolumbar.
METHODS


57 patients with compression fractures of thoracolumbar who were treated with PKP in The Second People's Hospital of Weifang from December 2014 to August 2016 were selected. Patients were randomly divided into DynaCT+DSA treatment group (27 cases) and DSA treatment group (30 cases) for PKP surgery. There were 19 cases of simple thoracic compression fractures, 28 cases of simple lumbar compression fractures, and 10 cases of thoracic vertebral compression fractures. Bone cement filling and leakage conditions were recorded after surgery. Efficacy of PKP was evaluated at 3 days after operation using visual analogue scale (VAS) and the maximal depth of the affected vertebrae. 71 lesioned vertebrae were treated and all punctures were successful.
RESULTS


VAS score and height of the largest depression in vertebrae were significantly improved after surgery (p<0.05), while no significant differences were found between 2 groups. The leakage rate of bone cement in the two groups was 24.3% and 18.4%, respectively.
CONCLUSION


DynaCT can be used to guide the development of vertebral puncture program before PKP, guide the accurate puncture during operation, and can be used to evaluate the leakage of bone cement timely and reliably.",2019,"RESULTS


VAS score and height of the largest depression in vertebrae were significantly improved after surgery (p<0.05), while no significant differences were found between 2 groups.","['compression fractures of thoracolumbar', ""57 patients with compression fractures of thoracolumbar who were treated with PKP in The Second People's Hospital of Weifang from December 2014 to August 2016 were selected""]","['PKP', 'percutaneous kyphoplasty (PKP', 'DynaCT+DSA', 'DynaCT', 'PKP surgery', 'DSA treatment']","['visual analogue scale (VAS) and the maximal depth of the affected vertebrae', 'VAS score and height of the largest depression in vertebrae', 'Bone cement filling and leakage conditions', 'leakage rate of bone cement']","[{'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0005934', 'cui_str': 'Bone Pastes'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",57.0,0.0135821,"RESULTS


VAS score and height of the largest depression in vertebrae were significantly improved after surgery (p<0.05), while no significant differences were found between 2 groups.","[{'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'He', 'Affiliation': ""Department of Interventional Therapy, The Second People's Hospital of Weifang, P.R. China.""}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Kunning', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Aiqiang', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': ''}]",Journal of musculoskeletal & neuronal interactions,[]
926,31797203,Efficacy of early combination of local radiotherapy and GM-CSF for advanced non-small cell lung cancer treated with icotinib.,"BACKGROUND


Lung cancer is a disease that severely endangers human health. Non-small cell lung cancer (NSCLC) accounts for approximately 4/5 of lung cancers.
AIMS


To investigate the efficacy of early combination of local radiotherapy and granulocyte macrophage colony-stimulating factor (GM-CSF) for advanced NSCLC treated with icotinib.
METHODS


Forty-two patients with stage IV NSCLC complicated with EGFR gene mutation were selected and randomly divided into two groups, with 21 patients in each group. Patients in control group were treated with icotinib, and patients in experimental group were treated with icotinib combined with local radiotherapy and subcutaneous injection of GM-CSF. One-year progression free survival between two groups was compared.
RESULTS


Three months after treatment, the efficacy in experimental group was significantly better than that in control group, and objective response rate was 95.24% in experimental group, which was higher than the 71.43% in control group. Patients in experimental group had no differences in white blood cell and neutrophil, but had significantly lower carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8+ than those in control group and before treatment. There were no differences in the proportion of patients with adverse reactions between two groups. One-year progression free survival was significantly better in experimental group than in control group.
CONCLUSIONS


Early combination of local radiotherapy and GM-CSF has a significant efficacy for advanced NSCLC accounts for approximately 4/5 of lung cancers treated with icotinib, and it can improve patients' autoimmunity and lengthen progression free survival.",2020,"Patients in experimental group had no differences in white blood cell and neutrophil, but had significantly lower carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8+ than those in control group and before treatment.","['advanced non-small cell lung cancer treated with icotinib', 'Forty-two patients with stage IV NSCLC complicated with EGFR gene mutation']","['icotinib combined with local radiotherapy and subcutaneous injection of GM-CSF', 'local radiotherapy and GM-CSF', 'local radiotherapy and granulocyte macrophage colony-stimulating factor (GM-CSF', 'icotinib']","['carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8', 'white blood cell and neutrophil', 'objective response rate', 'progression free survival', 'proportion of patients with adverse reactions']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2604307', 'cui_str': '4-((3-ethynylphenyl)amino)-6,7-benzo-12-crown-4-quinazoline'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C3266992', 'cui_str': 'Epidermal growth factor receptor gene mutation'}]","[{'cui': 'C2604307', 'cui_str': '4-((3-ethynylphenyl)amino)-6,7-benzo-12-crown-4-quinazoline'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]","[{'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C1880904', 'cui_str': 'Nervous System-Specific Enolase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",42.0,0.0248504,"Patients in experimental group had no differences in white blood cell and neutrophil, but had significantly lower carcino-embryonic antigen and neuron-specific enolase levels and higher CD3+, CD4+, and CD4+/CD8+ than those in control group and before treatment.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Departments of Oncology, The Second People's Hospital of Yibin, No.268 Nanguang Road, Cuiping District, Yibin, 644000, Sichuan Province, China.""}, {'ForeName': 'Xinyun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Oncology, The Guizhou Provincial People's Hospital, Guiyang, Guizhou Province, China.""}, {'ForeName': 'Zepei', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, The Second People's Hospital of Yibin, No.96 North Street, Cuiping District, 644000, Yibin, Sichuan Province, China.""}, {'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Departments of Oncology, The Second People's Hospital of Yibin, No.268 Nanguang Road, Cuiping District, Yibin, 644000, Sichuan Province, China.""}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': ""Departments of Oncology, The Second People's Hospital of Yibin, No.268 Nanguang Road, Cuiping District, Yibin, 644000, Sichuan Province, China. jiayuming8djf@163.com.""}]",Irish journal of medical science,['10.1007/s11845-019-02137-x']
927,31186389,Effects of progressive resistance exercises on quality of life and functional capacity in pediatric patients with chronic kidney disease: a randomized trail.,"AIM


To investigate the effects of progressive resistance exercises on quality of life and functional capacity in pediatric patients with chronic kidney disease.
METHODS


Thirty-two children with chronic kidney disease from both genders, age ranged from 8 to 12 years participated in this study. They were allocated randomly into two groups of equal numbers, standard medical care (SC) and exercise (EX) groups. The SC group received standard medical care with no change of their regular daily activities. The EX group received progressive resistance exercises for 60 minutes two times a week in addition to the standard medical care for six successive months.
OUTCOME MEASURES


Included the pediatric quality of life inventory and six-minutes walking test to assess quality of life and functional capacity respectively.
RESULTS


There were statistically significant improvements in the post-test quality of life and functional capacity in the EX group (p<0.05). The SC group showed significant decrease of quality of life and non-significant change was recorded regarding their functional capacity (p<0.05). The post-test comparison between the two groups revealed significant difference in favor of the EX group in all measured variables.
CONCLUSION


Progressive resistance exercises contributed to the improvement of quality of life and functional capacity in pediatric patients with chronic kidney disease.",2019,There were statistically significant improvements in the post-test quality of life and functional capacity in the EX group (p<0.05).,"['pediatric patients with chronic kidney disease', 'Thirty-two children with chronic kidney disease from both genders, age ranged from 8 to 12 years participated in this study']","['standard medical care with no change of their regular daily activities', 'Progressive resistance exercises', 'standard medical care (SC) and exercise (EX', 'progressive resistance exercises']","['pediatric quality of life inventory and six-minutes walking test to assess quality of life and functional capacity respectively', 'quality of life and functional capacity', 'quality of life', 'post-test quality of life and functional capacity']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",32.0,0.0179173,There were statistically significant improvements in the post-test quality of life and functional capacity in the EX group (p<0.05).,"[{'ForeName': 'Amira M', 'Initials': 'AM', 'LastName': 'Abd-Elmonem', 'Affiliation': 'Physical Therapy For Pediatrics Department, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Amira M', 'Initials': 'AM', 'LastName': 'Al-Tohamy', 'Affiliation': ''}, {'ForeName': 'Rasha Ee', 'Initials': 'RE', 'LastName': 'Galal', 'Affiliation': ''}, {'ForeName': 'Fatma A', 'Initials': 'FA', 'LastName': 'Abd-Elhalim', 'Affiliation': ''}]",Journal of musculoskeletal & neuronal interactions,[]
928,31129017,Neer Award 2019: Latarjet procedure vs. iliac crest bone graft transfer for treatment of anterior shoulder instability with glenoid bone loss: a prospective randomized trial.,"BACKGROUND


The Latarjet and iliac crest bone graft transfer (ICBGT) procedures are competing treatment options for anterior shoulder instability with glenoid bone loss.
METHODS


In this bicentric prospective randomized study, 60 patients with anterior shoulder instability and glenoid bone loss were included and randomized to either an open Latarjet or open ICBGT (J-bone graft) procedure. Clinical evaluation was completed before surgery and 6, 12, and 24 months after surgery, including the Western Ontario Shoulder Instability index, Rowe score, Subjective Shoulder Value, pain level, satisfaction level, and work and sports impairment, as well as assessment of instability, range of motion, and strength. Adverse events were prospectively recorded. Radiographic evaluation included preoperative, postoperative, and follow-up computed tomography analysis.
RESULTS


None of the clinical scores showed a significant difference between the 2 groups (P > .05). Strength and range of motion showed no significant differences except for diminished internal rotation capacity in the Latarjet group at every follow-up time point (P < .05). A single postoperative traumatic subluxation event occurred in 2 ICBGT patients and 1 Latarjet patient. The type and severity of other adverse events were heterogeneous. Donor-site sensory disturbances were observed in 27% of the ICBGT patients. Computed tomography scans revealed a larger glenoid augmentation effect of the ICBGTs; this, however, was attenuated at follow-up.
CONCLUSION


The Latarjet and ICBGT procedures for the treatment of anterior shoulder instability with glenoid bone loss showed no difference in clinical and radiologic outcomes except for significantly worse internal rotation capacity in the Latarjet group and frequently noted donor-site sensory disturbances in the ICBGT group.",2019,Strength and range of motion showed no significant differences except for diminished internal rotation capacity in the Latarjet group at every follow-up time point (P < .05).,"['Neer Award 2019', 'anterior shoulder instability with glenoid bone loss', '60 patients with anterior shoulder instability and glenoid bone loss']","['Computed tomography scans', 'open Latarjet or open ICBGT (J-bone graft) procedure', 'Latarjet procedure vs. iliac crest bone graft transfer', 'Latarjet and iliac crest bone graft transfer (ICBGT) procedures']","['Donor-site sensory disturbances', 'internal rotation capacity', 'Western Ontario Shoulder Instability index, Rowe score, Subjective Shoulder Value, pain level, satisfaction level, and work and sports impairment, as well as assessment of instability, range of motion, and strength', 'Adverse events']","[{'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable (finding)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3697075', 'cui_str': 'Latarjet procedure'}, {'cui': 'C0223651', 'cui_str': 'Iliac Crest'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0348011', 'cui_str': 'Surgical transfer - action'}]","[{'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0152027', 'cui_str': 'Sensory Disorders'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0374487,Strength and range of motion showed no significant differences except for diminished internal rotation capacity in the Latarjet group at every follow-up time point (P < .05).,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Moroder', 'Affiliation': 'Department for Shoulder and Elbow Surgery, Center for Musculoskeletal Surgery, Campus Virchow, Charité-Universitaetsmedizin Berlin, Berlin, Germany. Electronic address: philipp.moroder@charite.de.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Schulz', 'Affiliation': 'Department of Traumatology and Sports Injuries, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Wierer', 'Affiliation': 'Department of Traumatology and Sports Injuries, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Auffarth', 'Affiliation': 'Department of Traumatology and Sports Injuries, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Habermeyer', 'Affiliation': 'Department of Shoulder and Elbow Surgery, ATOS Clinic Munich, Munich, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Resch', 'Affiliation': 'Department of Traumatology and Sports Injuries, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tauber', 'Affiliation': 'Department of Shoulder and Elbow Surgery, ATOS Clinic Munich, Munich, Germany.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.03.035']
929,31230988,Baseline characteristics did not identify people with low back pain who respond best to a Movement System Impairment-Based classification treatment.,"STUDY DESIGN


Secondary analysis of data from a randomized controlled trial.
BACKGROUND


Treatment based on the Movement System Impairment-Based classification for chronic low back pain results in the same benefit when compared to other forms of exercise. It is possible that participant's characteristics measured at baseline can identify people with chronic low back pain who would respond best to a treatment based on the Movement System Impairment model.
OBJECTIVES


To assess if specific characteristics of people with chronic low back pain measured at baseline can modify the effects of a treatment based on the Movement System Impairment model on pain and disability.
METHODS


Four variables assessed at baseline that could potentially modify the treatment effects of the treatment based on the Movement System Impairment model were selected (age, educational status, physical activity status and STarT back tool classification). Separate univariate models were used to investigate a possible modifier treatment effect of baseline participant's characteristics on pain and disability after the treatment. Findings of interaction values above 1 point for the outcome mean pain intensity or above 3 points for disability (Roland Morris questionnaire) were considered clinically relevant.
RESULTS


Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification.
CONCLUSION


Age, educational status, physical activity status and STarT back tool classification did not modify the effects of an 8-week treatment based on the Movement System Impairment model in patients with chronic low back pain. Registered at www.clinicaltrials.gov: NCT02221609 (https://clinicaltrials.gov/ct2/show/NCT02221609).",2020,"RESULTS


Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification.
","['patients with chronic low back pain', 'people with chronic low back pain']",[],"['educational status, physical activity status and STarT back tool classification', 'pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]",[],"[{'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.151896,"RESULTS


Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification.
","[{'ForeName': 'Daniel Camara', 'Initials': 'DC', 'LastName': 'Azevedo', 'Affiliation': 'Programa de Mestrado e Doutorado em Fisioterapia, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: danielazevedo@pucminas.br.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Henrique de Oliveira', 'Initials': 'HO', 'LastName': 'Santos', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Daniel Ribeiro', 'Initials': 'DR', 'LastName': 'Oliveira', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Joao Victor Leite de', 'Initials': 'JVL', 'LastName': 'Souza', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Leonardo Oliveira Pena', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Programa de Mestrado e Doutorado em Fisioterapia, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Musculoskeletal Division, The George Institute for Global Health, Sydney, NSW, Australia.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.05.006']
930,31775650,Enhanced coordination of care to reduce medication risks in older home care clients in primary care: a randomized controlled trial.,"BACKGROUND


As populations are aging, a growing number of home care clients are frail and use multiple, complex medications. Combined with the lack of coordination of care this may pose uncontrolled polypharmacy and potential patient safety risks. The aim of this study was to assess the impact of a care coordination intervention on medication risks identified in drug regimens of older home care clients over a one-year period.
METHODS


Two-arm, parallel, cluster randomized controlled trial with baseline and follow-up assessment at 12 months. The study was conducted in Primary Care in Lohja, Finland: all 5 home care units, the public healthcare center, and a private community pharmacy.
PARTICIPANTS


All consented home care clients aged > 65 years, using at least one prescription medicine who were assessed at baseline and at 12 months.
INTERVENTION


Practical nurses were trained to make the preliminary medication risk assessment during home visits and report findings to the coordinating pharmacist. The coordinating pharmacist prepared the cases for the triage meeting with the physician and home care nurse to decide on further actions. Each patient's physician made the final decisions on medication changes needed. Outcomes were measured as changes in medication risks: use of potentially inappropriate medications and psychotropics; anticholinergic and serotonergic load; drug-drug interactions.
RESULTS


Participants (n = 129) characteristics: mean age 82.8 years, female 69.8%, mean number of prescription medicines in use 13.1. The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use. Half (50.0%) of the participants with a potential need for medication changes, agreed on in the triage meeting, had none of the medication changes actually implemented.
CONCLUSION


The care coordination intervention used in this study indicated tendency for effectiveness when implemented as planned. Even though the outcome of the intervention was not optimal, the value of this paper is in discussing the real world experiences and challenges of implementing new practices in home care.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02545257). Registered September 9 2015.",2019,"The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use.","['Participants (n\u2009=\u2009129) characteristics: mean age 82.8\u2009years, female 69.8%, mean number of prescription medicines in use 13.1', 'older home care clients in primary care', 'Primary Care in Lohja, Finland: all 5 home care units, the public healthcare center, and a private community pharmacy', 'older home care clients over a one-year period', 'All consented home care clients aged >\u200965\u2009years, using at least one prescription medicine who were assessed at baseline and at 12\u2009months']",['care coordination intervention'],"['medication risks', 'changes in medication risks: use of potentially inappropriate medications and psychotropics; anticholinergic and serotonergic load; drug-drug interactions']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.032924,"The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use.","[{'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Toivo', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland. terhi.toivo@helsinki.fi.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Airaksinen', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Dimitrow', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Savela', 'Affiliation': '1st Pharmacy of Lohja, Laurinkatu 37-41 A, 08100, Turku, Finland.'}, {'ForeName': 'Katariina', 'Initials': 'K', 'LastName': 'Pelkonen', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Valtteri', 'Initials': 'V', 'LastName': 'Kiuru', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Tuula', 'Initials': 'T', 'LastName': 'Suominen', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Uunimäki', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Sirkka-Liisa', 'Initials': 'SL', 'LastName': 'Kivelä', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Leikola', 'Affiliation': '1st Pharmacy of Lohja, Laurinkatu 37-41 A, 08100, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Puustinen', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}]",BMC geriatrics,['10.1186/s12877-019-1353-2']
931,31228197,Promoting Volunteering Among Older Adults in Hong Kong: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Volunteering has consistently been associated with better mental, physical, and cognitive health in older adulthood. However, the volunteering rate of older adults in Hong Kong is much lower than in Western countries. Few studies have examined whether interventions can be effective in motivating older adults to volunteer in Hong Kong. To fill this gap, we conducted a randomized controlled trial to examine the impact of a theory-based social-cognitive intervention on volunteering.
RESEARCH DESIGN AND METHODS


A total of 264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage = 6.90 years, 81.06% female) were randomly assigned to either an experimental group or an active control group. Participants in the experimental group received 4 weekly 1-hr face-to-face volunteering intervention sessions. Those in the active control group received parallel sessions targeting physical activity instead of volunteering. The time spent on volunteering per month was self-reported and measured at baseline, 6 weeks, 3 months, and 6 months after the intervention. Self-efficacy, intention, action planning, and self-monitoring of volunteering were measured as mediators.
RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups. Self-efficacy, intention, and action planning consistently mediated the effect of the intervention on volunteering minutes.
DISCUSSION AND IMPLICATIONS


The findings demonstrate the effectiveness of the intervention on volunteering behavior in older adults in Hong Kong through well-established behavior change techniques.",2020,"RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups.","['older adulthood', 'Older Adults in Hong Kong', 'motivating older adults to volunteer in Hong Kong', '6.90 years, 81.06% female', '264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage ', 'older adults']","['active control group', 'parallel sessions targeting physical activity instead of volunteering', 'theory-based social-cognitive intervention', '4 weekly 1-hr face-to-face volunteering intervention sessions']","['Self-efficacy, intention, action planning, and self-monitoring of volunteering', 'volunteering behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",264.0,0.0563992,"RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups.","[{'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Warner', 'Affiliation': 'Department of Psychology, MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Alice Ming-Lin', 'Initials': 'AM', 'LastName': 'Chong', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Kowloon Tong, Hong Kong, China.'}, {'ForeName': 'Tianyuan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Centre for Psychosocial Health, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Wolff', 'Affiliation': 'Department of Psychology, Friedrich-Alexander-University (FAU) Erlangen-Nuremberg, Institute of Psychogerontology, Nuremberg, Germany.'}, {'ForeName': 'Kee-Lee', 'Initials': 'KL', 'LastName': 'Chou', 'Affiliation': 'Department of Asian and Policy Studies, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}]",The Gerontologist,['10.1093/geront/gnz076']
932,31227804,Fatty acid regio-specificity of triacylglycerol molecules may affect plasma lipid responses to dietary fats-a randomised controlled cross-over trial.,"BACKGROUND/OBJECTIVES


Hypercholesterolaemic effects of saturated fatty acids (SFA) may be influenced not only by the chain length, but also by their specific location within the triacylglycerol (TAG) molecule. We examined the hypothesis that dietary fats rich in SFA, but containing mostly unsaturated fatty acids in the sn-2 position with most SFA in sn-1 and -3 (palm olein [PO] and cocoa butter [CB]) will have similar serum lipid outcomes to unsaturated olive oil (OO).
SUBJECTS/METHODS


Thirty-eight participants (20-40 yr, 18.5- ≤ 27.5 kg/m 2 ) completed a 4-week randomised 3 × 3 crossover feeding intervention, preceded by 2-week run-in and separated by 2-week washout periods. Background diet contained 35 percentage of total energy (%E) fat, 18%E protein, 48%E carbohydrates, differing in test fats only (palm olein (PO), CB, OO; 20%E). Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions, were assessed pre- and post-intervention. Data were analysed using mixed effects longitudinal models with a P-value < 0.05 considered significant.
RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB. No differences were seen for TC/HDL-C (mean [95%CI] change for PO, 0.08[0.00, 0.15] mmol/L; CB, 0.06 [-0.05, 0.16] mmol/L; and OO, -0.01 [-0.15, 0.13] mmol/L; P = 0.53] or any other parameter including LDL sub-fractions. OO decreased IDL-A compared to PO (-2.2 [-4.31, -0.21] mg/dL, P = 0.03).
CONCLUSION


In healthy young participants, plasma lipid responses to PO and CB, enriched in SFA but having primarily unsaturated fatty acid in the sn-2 position of TAG, did not differ from OO.",2020,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","['Thirty-eight participants (20-40\u2009yr, 18.5-\u2009≤\u200927.5', 'healthy young participants']",['saturated fatty acids (SFA'],"['plasma fatty acids', 'plasma lipid responses', 'TC/HDL-C', 'OO and C18:0', 'Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",38.0,0.0699815,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","[{'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia. welma.stonehouse@csiro.au.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'James-Martin', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mahinda', 'Initials': 'M', 'LastName': 'Abeywardena', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0452-7']
933,31606032,"Intensified household contact tracing, prevention and treatment support versus enhanced standard of care for contacts of tuberculosis cases in South Africa: study protocol for a household cluster-randomised trial.","BACKGROUND


Household contact tracing of index TB cases has been advocated as a key part of TB control for many years, but has not been widely implemented in many low-resource setting because of the current dearth of high quality evidence for effectiveness. Innovative strategies for earlier, more effective treatment are particularly important in contexts with hyper-endemic levels of HIV, where levels of TB infection remain extremely high.
METHODS


We present the design of a household cluster-randomised controlled trial of interventions aimed at improving TB-free survival and reducing childhood prevalence of Mycobacterium tuberculosis infection among household contacts of index TB cases diagnosed in two provinces of South Africa. Households of index TB cases will be randomly allocated in a 1:1 ratio to receive either an intensified home screening and linkage for TB and HIV intervention, or enhanced standard of care. The primary outcome will compare between groups the TB-free survival of household contacts over 15 months. All participants, or their next-of-kin, will provide written informed consent to participate.
DISCUSSION


Evidence from randomised trials is required to identify cost-effective approaches to TB case-finding that can be applied at scale in sub-Saharan Africa.
TRIAL REGISTRATION


ISRCTN16006202 (01/02/2017: retrospectively registered) and NHREC4399 (11/04/2016: prospectively registered). Protocol version: 4.0 (date: 18th January 2018).",2019,We present the design of a household cluster-randomised controlled trial of interventions aimed at improving TB-free survival and reducing childhood prevalence of Mycobacterium tuberculosis infection among household contacts of index TB cases diagnosed in two provinces of South Africa.,"['Households of index TB cases', 'household contacts of index TB cases diagnosed in two provinces of South Africa']","['intensified home screening and linkage for TB and HIV intervention, or enhanced standard of care', 'Intensified household contact tracing, prevention and treatment support versus enhanced standard of care']",['TB-free survival of household contacts'],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0079161', 'cui_str': 'Communicable Disease Contact Tracing'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0020052', 'cui_str': 'Households'}]",,0.347757,We present the design of a household cluster-randomised controlled trial of interventions aimed at improving TB-free survival and reducing childhood prevalence of Mycobacterium tuberculosis infection among household contacts of index TB cases diagnosed in two provinces of South Africa.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacPherson', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital, Blantyre, Malawi. peter.macpherson@lstmed.ac.uk.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'Department of Internal Medicine, Klerksdorp Tshepong Hospital Complex and University of the Witwatersrand, Klerksdorp, South Africa.'}, {'ForeName': 'Sanjay G', 'Initials': 'SG', 'LastName': 'Lala', 'Affiliation': 'Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Soweto, South Africa.'}, {'ForeName': 'Minja', 'Initials': 'M', 'LastName': 'Milovanovic', 'Affiliation': 'Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Soweto, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ratsela', 'Affiliation': 'Department of Medicine, Polokwane and Mankweng Hospitals, University of Limpopo, Polokwane, South Africa.'}, {'ForeName': 'Limakatso', 'Initials': 'L', 'LastName': 'Lebina', 'Affiliation': 'Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Soweto, South Africa.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Kinghorn', 'Affiliation': 'Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, Soweto, South Africa.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Martinson', 'Affiliation': 'Department of Internal Medicine, Klerksdorp Tshepong Hospital Complex and University of the Witwatersrand, Klerksdorp, South Africa.'}]",BMC infectious diseases,['10.1186/s12879-019-4502-5']
934,31793084,Ultraslow full-power shock wave lithotripsy versus slow power-ramping shock wave lithotripsy in stones with high attenuation value: A randomized comparative study.,"OBJECTIVES


To compare the efficacy and safety of ultraslow full-power versus slow rate, power-ramping shock wave lithotripsy in the management of stones with a high attenuation value.
METHODS


This was a randomized comparative study enrolling patients with single high attenuation value (≥1000 Hounsfield unit) stones (≤3 cm) between September 2015 and May 2018. Patients with skin-to-stone distance >11 cm or body mass index >30 kg/m 2  were excluded. Electrohydraulic shock wave lithotripsy was carried out at rate of 30 shock waves/min for group A versus 60 shock waves/min for group B. In group A, power ramping was from 6 to 18 kV for 100 shock waves, then a safety pause for 2 min, followed by ramping 18-22 kV for 100 shock waves, then a safety pause for 2 min. This full power (22 kV) was maintained until the end of the session. In group B, power ramping was carried out with an increase of 4 kV each 500 shock waves, then maintained on 22 kV in the last 1000-1500 shock waves. Follow up was carried out up to 3 months after the last session. Perioperative data were compared, including the stone free rate (as a primary outcome) and complications (secondary outcome). Predicting factors for success were analyzed using logistic regression.
RESULTS


A total of 100 patients in group A and 96 patients in group B were included. The stone-free rate was significantly higher in group A (76% vs 38.5%; P < 0.001). Both groups were comparable in complication rates (20% vs 19.8%; P = 0.971). The stone-free rate remained significantly higher in group A in logistic regression analysis (odds ratio 24.011, 95% confidence interval 8.29-69.54; P < 0.001).
CONCLUSIONS


Ultraslow full-power shock wave lithotripsy for high attenuation value stones is associated with an improved stone-free rate without affecting safety. Further validation studies are required using other shock wave lithotripsy machines.",2020,Both groups were comparable in complication rates (20% vs 19.8%; P = 0.971).,"['100 patients in group', 'Patients with skin-to-stone distance >11\xa0cm or body mass index', '96 patients in group\xa0B were included', 'enrolling patients with single high attenuation value (≥1000\xa0Hounsfield unit) stones (≤3\xa0cm) between September 2015 and May 2018', 'stones with high attenuation value', '30\xa0kg/m 2  were excluded']","['Ultraslow full-power shock wave lithotripsy', 'ultraslow full-power versus slow rate, power-ramping shock wave lithotripsy', 'Ultraslow full-power shock wave lithotripsy versus slow power-ramping shock wave lithotripsy', 'Electrohydraulic shock wave lithotripsy']","['stone free rate', 'complication rates', 'stone-free rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0348053', 'cui_str': 'Ramping (qualifier value)'}, {'cui': 'C0442829', 'cui_str': 'Electrohydraulic (qualifier value)'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",100.0,0.0837611,Both groups were comparable in complication rates (20% vs 19.8%; P = 0.971).,"[{'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Al-Dessoukey', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abdallah', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ayman S', 'Initials': 'AS', 'LastName': 'Moussa', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Sayed', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abdelbary', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Rabie', 'Initials': 'R', 'LastName': 'Abdallah', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Massoud', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Abdelhamid', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Akram A', 'Initials': 'AA', 'LastName': 'Elmarakbi', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Ragheb', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Mohammed S', 'Initials': 'MS', 'LastName': 'ElSheemy', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Ghoneima', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14158']
935,31221782,Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies.,"The phase 3 POLLUX and CASTOR studies demonstrated superior benefit of daratumumab plus lenalidomide/dexamethasone or bortezomib/dexamethasone in relapsed/refractory multiple myeloma. Efficacy and safety of daratumumab was analyzed according to age groups of 65 to 74 years and ≥75 years. Patients received ≥1 prior line of therapy. In POLLUX, patients received lenalidomide/dexamethasone ± daratumumab (16 mg/kg weekly, cycles 1-2; every two weeks, cycles 3-6; monthly until progression). In CASTOR, patients received eight cycles of bortezomib/dexamethasone ± daratumumab (16 mg/kg weekly, cycles 1-3; every three weeks, cycles 4-8; monthly until progression). Patients aged >75 years received dexamethasone 20 mg weekly. For patients aged ≥75 years in POLLUX (median follow-up: 25.4 months), daratumumab/lenalido-mide/dexamethasone prolonged progression-free survival  versus  lenalido-mide/dexamethasone (median: 28.9  versus  11.4 months; hazard ratio, 0.27; 95% confidence interval, 0.10-0.69;  P =0.0042) and increased overall response rate (93.1%  versus  76.5%;  P =0.0740). Neutropenia was the most common grade 3/4 treatment-emergent adverse event (daratumumab: 44.8%; control: 31.4%). Infusion-related reactions occurred in 12 (41.4%) patients. For patients aged ≥75 years in CASTOR (median follow-up: 19.4 months), daratumumab/bortezomib/dexamethasone prolonged progression-free survival versus bortezomib/dexamethasone (median: 17.9  versus  8.1 months; hazard ratio, 0.26; 95% confidence interval, 0.10-0.65;  P =0.0022) and increased overall response rate (95.0%  versus  78.8%;  P =0.1134). Thrombocytopenia was the most common grade 3/4 treatment-emergent adverse event (daratumumab: 45.0%; control: 37.1%). Infusion-related reactions occurred in 13 (65.0%) patients. Similar findings were reported for patients aged 65 to 74 years in both studies. Taken together, this subgroup analysis of efficacy and safety of daratumumab was largely consistent with the overall populations.",2020,Neutropenia was the most common grade 3/4 treatment-emergent adverse event (daratumumab: 44.8%; control: 31.4%).,"['patients aged 65 to 74 years in both studies', 'age groups of 65 to 74 years and ≥75 years', 'Patients aged >75 years received']","['lenalidomide/dexamethasone ± daratumumab', 'bortezomib/dexamethasone', 'dexamethasone or bortezomib/dexamethasone', 'dexamethasone', 'daratumumab/bortezomib/dexamethasone', 'lenalidomide/dexamethasone', 'bortezomib/dexamethasone ± daratumumab', 'daratumumab/lenalidomide/dexamethasone']","['Thrombocytopenia', 'Neutropenia', 'overall response rate', 'Efficacy and safety of daratumumab']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}]",,0.20972,Neutropenia was the most common grade 3/4 treatment-emergent adverse event (daratumumab: 44.8%; control: 31.4%).,"[{'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL, Salamanca, Spain mvmateos@usal.es.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Institute of Hematology Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Laubach', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, United Kingdom.""}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Tom Baker Cancer Center, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Schecter', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""O'Rourke"", 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}]",Haematologica,['10.3324/haematol.2019.217448']
936,31791688,"Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal carcinoma treatment (ICON8): primary progression free survival analysis results from a GCIG phase 3 randomised controlled trial.","BACKGROUND


Carboplatin and paclitaxel administered every 3 weeks is standard-of-care first-line chemotherapy for epithelial ovarian cancer. The Japanese JGOG3016 trial showed a significant improvement in progression-free and overall survival with dose-dense weekly paclitaxel and 3-weekly carboplatin. In this study, we aimed to compare efficacy and safety of two dose-dense weekly regimens to standard 3-weekly chemotherapy in a predominantly European population with epithelial ovarian cancer.
METHODS


In this phase 3 trial, women with newly diagnosed International Federation of Gynecology and Obstetrics stage IC-IV epithelial ovarian cancer were randomly assigned to group 1 (carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2  paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2  paclitaxel weekly), or group 3 (carboplatin AUC2 and 80 mg/m 2  paclitaxel weekly). Written informed consent was provided by all women who entered the trial. The protocol had the appropriate national research ethics committee approval for the countries where the study was conducted. Patients entered the trial after immediate primary surgery, or before neoadjuvant chemotherapy with subsequent planned delayed primary surgery. The trial coprimary outcomes were progression-free survival and overall survival. Data analyses were done on an intention-to-treat basis, and were powered to detect a hazard ratio of 0·75 in progression-free survival. The main comparisons were between the control group (group 1) and each of the weekly research groups (groups 2 and 3).
FINDINGS


Between June 6, 2011, and Nov 28, 2014, 1566 women were randomly assigned to treatment. 72% (365), completed six protocol-defined treatment cycles in group 1, 60% (305) in group 2, and 63% (322) in group 3, although 90% (454), 89% (454), and 85% (437) completed six platinum-based chemotherapy cycles, respectively. Paclitaxel dose intensification was achieved with weekly treatment (median total paclitaxel dose 1010 mg/m 2  in group 1; 1233 mg/m 2  in group 2; 1274 mg/m 2  in group 3). By February, 2017, 1018 (65%) patients had experienced disease progression. No significant progression-free survival increase was observed with either weekly regimen (restricted mean survival time 24·4 months [97·5% CI 23·0-26·0] in group 1, 24·9 months [24·0-25·9] in group 2, 25·3 months [23·9-26·9] in group 3; median progression-free survival 17·7 months [IQR 10·6-not reached] in group 1, 20·8 months [11·9-59·0] in group 2, 21·0 months [12·0-54·0] in group 3; log-rank p=0·35 for group 2 vs group 1; group 3 vs 1 p=0·51). Although grade 3 or 4 toxic effects increased with weekly treatment, these effects were predominantly uncomplicated. Febrile neutropenia and sensory neuropathy incidences were similar across groups.
INTERPRETATION


Weekly dose-dense chemotherapy can be delivered successfully as first-line treatment for epithelial ovarian cancer but does not significantly improve progression-free survival compared with standard 3-weekly chemotherapy in predominantly European populations.
FUNDING


Cancer Research UK, Medical Research Council, Health Research Board in Ireland, Irish Cancer Society, Cancer Australia.",2019,"No significant progression-free survival increase was observed with either weekly regimen (restricted mean survival time 24·4 months [97·5% CI 23·0-26·0] in group 1, 24·9 months [24·0-25·9] in group 2, 25·3 months [23·9-26·9] in group 3; median progression-free survival 17·7 months [IQR 10·6-not reached] in group 1, 20·8 months [11·9-59·0] in group 2, 21·0 months [12·0-54·0] in group 3; log-rank p=0·35 for group 2 vs group 1; group 3 vs 1 p=0·51).","['Between June 6, 2011, and Nov 28, 2014, 1566 women', 'epithelial ovarian cancer', 'predominantly European population with epithelial ovarian cancer', 'women with newly diagnosed International Federation of Gynecology and Obstetrics stage IC-IV epithelial ovarian cancer']","['neoadjuvant chemotherapy with subsequent planned delayed primary surgery', 'Carboplatin and paclitaxel', 'group 1 (carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2  paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2  paclitaxel weekly), or group 3 (carboplatin AUC2 and 80 mg/m 2  paclitaxel', 'Paclitaxel', 'primary peritoneal carcinoma treatment (ICON8']","['toxic effects', 'Febrile neutropenia and sensory neuropathy incidences', 'disease progression', 'progression-free and overall survival', 'efficacy and safety', 'progression-free survival increase', 'progression-free survival', 'median progression-free survival', 'progression-free survival and overall survival']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1566.0,0.186979,"No significant progression-free survival increase was observed with either weekly regimen (restricted mean survival time 24·4 months [97·5% CI 23·0-26·0] in group 1, 24·9 months [24·0-25·9] in group 2, 25·3 months [23·9-26·9] in group 3; median progression-free survival 17·7 months [IQR 10·6-not reached] in group 1, 20·8 months [11·9-59·0] in group 2, 21·0 months [12·0-54·0] in group 3; log-rank p=0·35 for group 2 vs group 1; group 3 vs 1 p=0·51).","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie National Health Service Foundation Trust, and University of Manchester, Manchester, UK.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'James', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials & Methodology, University College London, London, UK. Electronic address: e.james@ucl.ac.uk.'}, {'ForeName': 'Iain A', 'Initials': 'IA', 'LastName': 'McNeish', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Oncology Department, St John of God Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Dearbhaile M', 'Initials': 'DM', 'LastName': ""O'Donnell"", 'Affiliation': 'Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hook', 'Affiliation': ""St James' University Hospital, Leeds, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Queen Alexandra Hospital, Portsmouth Hospitals National Health Service Trust, Portsmouth, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blagden', 'Affiliation': 'Churchill Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brenton', 'Affiliation': 'Li Ka Shing Centre, Cancer Research UK Cambridge Institute, Cambridge, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Naik', 'Affiliation': 'Gynaecology Oncology Centre, Queen Elizabeth Hospital, Gateshead, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': ""St James' University Hospital, Leeds, UK.""}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': 'Institute of Cancer and Genomics, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Cook', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials & Methodology, University College London, London, UK.'}, {'ForeName': 'Gosala S', 'Initials': 'GS', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials & Methodology, University College London, London, UK.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Gabra', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK; Early Clinical Development, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Lord', 'Affiliation': 'Department of Oncology, Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Dark', 'Affiliation': 'Northern Centre for Cancer Care, Freeman Hospital, Newcastle, UK.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Earl', 'Affiliation': ""Department of Medical Oncology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Gynaecological Unit, The Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rosalind M', 'Initials': 'RM', 'LastName': 'Glasspool', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Velindre Cancer Centre, Wales, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Birmingham City Hospital, Birmingham, UK.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Swart', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Stenning', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials & Methodology, University College London, London, UK.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials & Methodology, University College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials & Methodology, University College London, London, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'University College London Cancer Institute, and University College London Hospitals, London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)32259-7']
937,31216955,The effect of preconception counselling on health locus of control and stress in Iranian women: a randomized control trial.,"Preconception counseling can improve women's health and pregnancy outcomes. Internal health locus of control and belief in the benefits of health-promoting behaviors improve people's engagement in health-promoting behaviors. This study examined whether preconception counseling was related to stress and health locus of control. This randomized controlled trial was conducted from March to November 2016 on 152 healthy 18-35-year-old women intending to become pregnant within the next year in Iran. The intervention group received six sessions of group counseling, and the control group received only usual care. The Perceived Stress Scale, Multidimensional Health Locus of Control Scales and checklist for preconception control were completed before and after the intervention. Repeated measures ANOVA showed a significant post-intervention increase in the mean internal health locus of control ( P  < .001) and preconception control scores ( P  = .034) in the intervention group and the mean perceived stress score ( P  = .001), and chance health locus of control ( P  = .013) decreased significantly. Preconception counseling was associated with increased internal locus of control and reduced perceived stress. Preconception counselors should consider reinforcing women's internal beliefs with an emphasis on the effect of the couple's own behaviors and exposures on pregnancy and fetal outcomes.",2020,"< .001) and preconception control scores ( P  = .034) in the intervention group and the mean perceived stress score ( P  = .001), and chance health locus of control ( P  = .013) decreased significantly.","['March to November 2016 on 152 healthy 18-35-year-old women intending to become pregnant within the next year in Iran', 'Iranian women']","['Preconception counseling', 'preconception counselling', 'preconception counseling', 'six sessions of group counseling, and the control group received only usual care']","['internal locus of control and reduced perceived stress', 'preconception control scores', 'mean perceived stress score', 'Perceived Stress Scale, Multidimensional Health Locus of Control Scales and checklist for preconception control', ""women's health and pregnancy outcomes"", 'mean internal health locus of control ( P', 'chance health locus of control', 'health locus of control and stress']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0474171', 'cui_str': 'Pre-pregnancy education'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0582648', 'cui_str': 'Multidimensional health locus of control scale (assessment scale)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",152.0,0.0259526,"< .001) and preconception control scores ( P  = .034) in the intervention group and the mean perceived stress score ( P  = .001), and chance health locus of control ( P  = .013) decreased significantly.","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Babapour', 'Affiliation': 'Faculty of Psychology, Tabriz University, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Ghasemi Yngyknd', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Women & health,['10.1080/03630242.2019.1626790']
938,31791008,Keeping it together for the kids: New mothers' descriptions of the impact of intimate partner violence on parenting.,"BACKGROUND


Intimate partner violence (IPV) affects 1 in 3 US women with the effects of IPV detectable for several generations. While IPV is known to have significant impacts on maternal-child outcomes, little is known about the mother's perspectives of the interplay between perinatal IPV exposure, parenting styles, and safety strategies.
METHODS


This secondary analysis of semi-structured, longitudinal qualitative interview data explored with pregnant women their histories of IPV, their parenting practices, and safety strategies. Data were derived from a randomized controlled trial, DOVE, with 22 interviews from 11 women collected during pregnancy and 12 or 24 months postpartum.
RESULTS


Data were analyzed using constant comparative analysis resulting in three themes: ""broken spirit,"" ""I want better for my kids and me,"" and ""safety planning as an element of parenting."" Women described at baseline having a ""broken spirit"" due to their experiences with household and family chaos and childhood abuse. However, when mothers ended the abusive relationship, they described a better life and several strategies to protect themselves and their children. During their final interviews, mothers discussed how their lives improved after ending the relationship as well as safety planning strategies they employed like looking for ""red flags"" in potential partners, struggles with finding trustworthy childcare, and stockpiling money should they choose to end the relationship.
CONCLUSION


These rich data add new information about how mothers of very young children navigate difficult parenting and safety decisions in the context of lifetime traumatic events and provide insights relevant for practice and research with this highly-vulnerable group of IPV survivors.",2020,"During their final interviews, mothers discussed how their lives improved after ending the relationship as well as safety planning strategies they employed like looking for ""red flags"" in potential partners, struggles with finding trustworthy childcare, and stockpiling money should they choose to end the relationship.
","['22 interviews from 11 women collected during pregnancy and 12 or 24 months postpartum', 'pregnant women their histories of IPV, their parenting practices']",[],[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]",[],[],,0.0793694,"During their final interviews, mothers discussed how their lives improved after ending the relationship as well as safety planning strategies they employed like looking for ""red flags"" in potential partners, struggles with finding trustworthy childcare, and stockpiling money should they choose to end the relationship.
","[{'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Herbell', 'Affiliation': 'The Ohio State University College of Nursing, 1585 Neil Ave, Columbus, OH, 43210, United States. Electronic address: herbell.3@osu.edu.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'University of Missouri S235 School of Nursing, University of Missouri, Columbia, MO 65211, United States.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Bloom', 'Affiliation': 'University of Missouri S235 School of Nursing, University of Missouri, Columbia, MO 65211, United States.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Sharps', 'Affiliation': 'Johns Hopkins University School of Nursing, 525 N Wolfe St, Baltimore, MD 21205, United States.'}, {'ForeName': 'Linda F C', 'Initials': 'LFC', 'LastName': 'Bullock', 'Affiliation': 'University of Virginia School of Nursing, 225 Jeanette Lancaster Way, Charlottesville, VA 22903, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2019.104268']
939,29119864,"Associations between having an informal caregiver, social support, and self-care among low-income adults with poorly controlled diabetes.","Objective To determine whether the presence of an informal caregiver and the patient's level of social support are associated with better diabetes self-care among adults with poorly controlled diabetes. Methods Cross-sectional study using baseline data from 253 adults of age 30-70 with poorly controlled diabetes. Participants who reported receiving assistance with their diabetes from a friend or family member in the past month were classified as having a caregiver. We used multivariate linear and logistic regression models to evaluate the associations between having a caregiver and level of social support with five self-reported diabetes self-care behaviors: diet, foot checks, blood glucose monitoring, medications, and physical activity. Results Compared to participants with no informal caregiver, those with an informal caregiver were significantly more likely to report moderate or high medication adherence (OR = 1.93, 95% CI: 1.07-3.49, p = 0.028). When we included social support in the model, having a caregiver was no longer significantly associated with medication adherence (OR = 1.50, 95% CI: 0.80-2.82), but social support score was (OR = 1.22, 95% CI: 1.03-1.45, p = 0.023). Discussion Among low-income adults with poorly controlled diabetes, having both an informal caregiver and high social support for diabetes may have a beneficial effect on medication adherence, a key self-care target to improve diabetes control.",2017,"When we included social support in the model, having a caregiver was no longer significantly associated with medication adherence (OR = 1.50, 95% CI: 0.80-2.82), but social support score was (OR = 1.22, 95% CI: 1.03-1.45, p = 0.023).","['Participants who reported receiving assistance with their diabetes from a friend or family member in the past month were classified as having a caregiver', '253 adults of age 30-70 with poorly controlled diabetes', 'adults with poorly controlled diabetes', 'low-income adults with poorly controlled diabetes']",[],"['medication adherence', 'social support score', 'report moderate or high medication adherence']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0302604', 'cui_str': 'Low income'}]",[],"[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0037438'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",253.0,0.0333624,"When we included social support in the model, having a caregiver was no longer significantly associated with medication adherence (OR = 1.50, 95% CI: 0.80-2.82), but social support score was (OR = 1.22, 95% CI: 1.03-1.45, p = 0.023).","[{'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Bouldin', 'Affiliation': '1 Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services Research & Development, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'Ranak B', 'Initials': 'RB', 'LastName': 'Trivedi', 'Affiliation': '3 Center for Innovation to Implementation, Health Services Research & Development, VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Gayle E', 'Initials': 'GE', 'LastName': 'Reiber', 'Affiliation': '1 Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services Research & Development, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Rosland', 'Affiliation': '5 Center for Clinical Management Research, VA Ann Arbor Health Care System, Ann Arbor, MI, USA.'}, {'ForeName': 'Julie B', 'Initials': 'JB', 'LastName': 'Silverman', 'Affiliation': '1 Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services Research & Development, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Krieger', 'Affiliation': '2 Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Nelson', 'Affiliation': '1 Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services Research & Development, VA Puget Sound Health Care System, Seattle, WA, USA.'}]",Chronic illness,['10.1177/1742395317690032']
940,31206613,N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease.,"This study assessed the biological and clinical effects in patients with Parkinson's disease (PD) of N-acetyl-cysteine (NAC), the prodrug to l-cysteine, a precursor to the natural biological antioxidant glutathione. Forty-two patients with PD were randomized to either weekly intravenous infusions of NAC (50 mg/kg) plus oral doses (500 mg twice per day) for 3 months or standard of care only. Participants received prebrain and postbrain imaging with ioflupane (DaTscan) to measure dopamine transporter (DAT) binding. In the NAC group, significantly increased DAT binding was found in the caudate and putamen (mean increase from 3.4% to 8.3%) compared with controls (P < 0.05), along with significantly improved PD symptoms (P < 0.0001). The results suggest NAC may positively affect the dopaminergic system in patients with PD, with corresponding positive clinical effects. Larger scale studies are warranted.",2019,"In the NAC group significantly increased DAT binding was found in the caudate and putamen (mean increase from 3.4% to 8.3%) compared to controls (p<0.05), along with significantly improved PD symptoms (p<0.0001).","['Forty-two patients with PD', ""patients with Parkinson's disease (PD) of N-acetyl-cysteine (NAC""]","['pre and post brain imaging with ioflupane (DaTscan) to measure dopamine transporter (DAT) binding', 'NAC', 'N-Acetyl Cysteine']","['PD symptoms', 'DAT binding', 'dopaminergic system']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1956795', 'cui_str': '8-azabicyclo(3,2,1)octane-2-carboxylic acid, 8-(3-fluoropropyl)-3-(4-iodophenyl)-, methyl ester, (1R-(exo,exo))-'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Plasma Membrane Transport Proteins'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",42.0,0.0451377,"In the NAC group significantly increased DAT binding was found in the caudate and putamen (mean increase from 3.4% to 8.3%) compared to controls (p<0.05), along with significantly improved PD symptoms (p<0.0001).","[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Monti', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zabrecky', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kremens', 'Affiliation': ""Department of Neurology, Jefferson Comprehensive Parkinson's Disease and Movement Disorders Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Tsao-Wei', 'Initials': 'TW', 'LastName': 'Liang', 'Affiliation': ""Department of Neurology, Jefferson Comprehensive Parkinson's Disease and Movement Disorders Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Wintering', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Bazzan', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Marcus Institute of Integrative Health, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Brendan K', 'Initials': 'BK', 'LastName': 'Bowens', 'Affiliation': 'Marcus Institute of Integrative Health, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Chervoneva', 'Affiliation': 'Department of Biostatistics, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Intenzo', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Newberg', 'Affiliation': 'Department of Integrative Medicine and Nutritional Sciences, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1548']
941,31740429,CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment.,"BACKGROUND


Socioeconomically-disadvantaged households have a high prevalence of pediatric overweight/obesity, and also face barriers to accessing weight loss treatment in healthcare settings. Delivering family-based pediatric weight loss treatment in the home setting may enhance its efficacy by facilitating treatment attendance, enabling more tailored treatment recommendations informed by observations of the home environment, and increasing accountability. This paper describes the design of the Creating Health Environments for Chicago Kids (CHECK) Trial, which evaluates the efficacy, cost-effectiveness, and mechanisms of home visitation in family-based pediatric weight loss treatment for children in low-income households.
DESIGN


CHECK is a two-arm, parallel group, randomized controlled trial that is enrolling N = 266 children, ages 6-12 y, who have overweight/obesity (BMI percentile ≥85) and live in a low-income household. Participants are randomized in a 1:1 ratio to either standard of care family-based weight loss treatment delivered in the home, or the identical intervention delivered in an academic medical center. The primary outcome is change in child BMI z-score from baseline to 12 months. Program delivery costs are rigorously documented to enable cost-effectiveness analyses from the societal and payer perspectives. Objectively-documented changes to the home environment and aspects of intervention delivery (e.g., hours of in-person contact received, quantity of behavioral goals set per session) will be tested as hypothesized treatment mechanisms.
IMPLICATIONS


Findings will inform the design of future interventions, and treatment dissemination decisions by public health agencies and third-party payers.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03195790.",2020,"Delivering family-based pediatric weight loss treatment in the home setting may enhance its efficacy by facilitating treatment attendance, enabling more tailored treatment recommendations informed by observations of the home environment, and increasing accountability.","['Chicago Kids (CHECK', 'children in low-income households', 'Socioeconomically-disadvantaged households', 'enrolling N\u202f=\u202f266 children, ages 6-12 y, who have overweight/obesity (BMI percentile ≥85) and live in a low-income household']","['home visitation', 'CHECK', 'standard of care family-based weight loss treatment delivered in the home, or the identical intervention delivered in an academic medical center']","['change in child BMI z-score', 'efficacy, cost-effectiveness', 'efficacy and cost-effectiveness']","[{'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",266.0,0.0699766,"Delivering family-based pediatric weight loss treatment in the home setting may enhance its efficacy by facilitating treatment attendance, enabling more tailored treatment recommendations informed by observations of the home environment, and increasing accountability.","[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Appelhans', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, United States of America; Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, United States of America. Electronic address: brad_appelhans@rush.edu.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'French', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, United States of America.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Bradley', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'Department of Pediatrics, Rush University Medical Center, United States of America.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Janssen', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, United States of America; Department of Mathematics and Computer Science, Lake Forest College, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105891']
942,31740343,The effect of bisphosphosphonates on bone turnover and bone balance in postmenopausal women with osteoporosis: The T-score bone marker approach in the TRIO study.,"Postmenopausal osteoporosis is characterised by increased bone turnover and an imbalance between bone resorption and formation. Bisphosphonate treatment reduces bone turnover but their effect on bone balance is yet to be fully investigated. Using the T-score approach our aims were to: i) investigate the effects of oral nitrogen-containing bisphosphonates on bone balance and turnover in postmenopausal women with osteoporosis and ii) determine the relationship of the change in bone balance and turnover with the change in BMD at the lumbar spine and total hip. Women were recruited, mean age 67 years, and randomised to receive: ibandronate (n = 55, 150 mg/month), alendronate (n = 54, 70 mg/week) or risedronate (n = 56, 35 mg/week). They also received calcium and vitamin D daily. A fasting serum sample was collected at baseline and weeks 1, 2, 4, 12, 13, 48 and 96. The control group were 226 healthy premenopausal women receiving no treatments. PINP and CTX were measured using the iSYSIDS analyser and BMD (in g/cm2) of the lumbar spine and total hip were measured by DXA (Hologic Inc). PINP and CTX values were log10-transformed and normalised. T-scores were calculated using the mean and standard deviation from the premenopausal group. Bone turnover and bone balance were calculated from the T-scores. Mean levels (95% CI) of balance and turnover are shown in the table. The change in turnover at weeks 4, 12 and 48 was inversely correlated with the change in lumbar spine and total hip BMD at weeks 48 and 96, (p < .01 to p < .001). The change in balance at week 4 positively correlated with the change in total hip BMD at weeks 48, (p < .01). Bisphosphonates resulted in an initial positive balance and a reduction in turnover. Some of these changes were associated with increases in BMD. Bone turnover is a better predictor of BMD than bone balance.",2020,"The change in turnover at weeks 4, 12 and 48 was inversely correlated with the change in lumbar spine and total hip BMD at weeks 48 and 96, (p < .01 to p < .001).","['postmenopausal women with osteoporosis and ii', '226 healthy premenopausal women receiving no treatments', 'Women were recruited, mean age 67\u202fyears', 'postmenopausal women with osteoporosis']","['Bisphosphonates', 'calcium and vitamin D daily', 'ibandronate', 'alendronate', 'oral nitrogen-containing bisphosphonates', 'Bisphosphonate', 'risedronate', 'bisphosphosphonates']","['bone balance and turnover', 'total hip BMD', 'BMD', 'change in turnover', 'lumbar spine and total hip', 'Mean levels', 'lumbar spine and total hip BMD', 'Bone turnover and bone balance', 'T-scores', 'bone turnover and bone balance', 'PINP and CTX values']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",226.0,0.0331017,"The change in turnover at weeks 4, 12 and 48 was inversely correlated with the change in lumbar spine and total hip BMD at weeks 48 and 96, (p < .01 to p < .001).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gossiel', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, United Kingdom. Electronic address: f.gossiel@sheffield.ac.uk.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Paggiosi', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Naylor', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'McCloskey', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Peel', 'Affiliation': 'Metabolic Bone Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital Sheffield, United Kingdom.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, United Kingdom.'}]",Bone,['10.1016/j.bone.2019.115158']
943,31731005,"A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial.","BACKGROUND


Nonalcoholic steatohepatitis (NASH) is a multifactorial disease involving different contributing mechanisms, with no approved therapies so far. Tropifexor (TXR), a farnesoid X receptor agonist, and cenicriviroc (CVC), a chemokine receptor types 2/5 antagonist, target the steatotic, inflammatory, and/or fibrotic pathways involved in NASH.
DESIGN


TANDEM (CLJC242A2201J; NCT03517540) is a 48-week, phase 2b, randomized, double-blind, multicenter study in 200 adult patients with biopsy-proven NASH and liver fibrosis. Patients will be randomized in a 1:1:1:1 ratio to receive either TXR 140 μg once daily (qd), CVC 150 mg qd, TXR 140 μg + CVC 150 mg qd, or TXR 90 μg + CVC 150 mg qd. The study comprises a 48-week treatment period and 4 weeks of follow-up. The key inclusion criterion is presence of NASH with fibrosis stage F2/F3 as seen on screening liver biopsy or on historical liver biopsy performed within 6 months prior to screening.
OBJECTIVES


The primary objective is evaluation of the safety and tolerability of combination therapy compared with the monotherapies over 48 weeks. The secondary objective is to evaluate efficacy as assessed by ≥1-point improvement in liver fibrosis versus baseline or resolution of steatohepatitis after 48 weeks.
SUMMARY


TANDEM will evaluate the combination of TXR and CVC with respect to safety and efficacy outcomes related to improvement in fibrosis or resolution of steatohepatitis. Given the effects of TXR and CVC in multiple pathophysiological pathways associated with NASH, combination therapy is likely to show additional benefits compared with monotherapy.",2020,The primary objective is evaluation of the safety and tolerability of combination therapy compared with the monotherapies over 48 weeks.,"['200 adult patients with biopsy-proven NASH and liver fibrosis', 'patients with nonalcoholic steatohepatitis and liver fibrosis']","['TXR and CVC', 'Nonalcoholic steatohepatitis (NASH', 'combination therapy', 'TXR', 'Tropifexor (TXR', 'tropifexor and cenicriviroc', 'CVC 150\u202fmg qd, TXR 140\u202fμg\u202f+\u202fCVC 150\u202fmg qd, or TXR 90\u202fμg\u202f+\u202fCVC 150\u202fmg qd']","['safety and efficacy', 'safety and tolerability']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4279622'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",200.0,0.283176,The primary objective is evaluation of the safety and tolerability of combination therapy compared with the monotherapies over 48 weeks.,"[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Pedrosa', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Star', 'Initials': 'S', 'LastName': 'Seyedkazemi', 'Affiliation': 'Allergan plc, CA, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Francque', 'Affiliation': 'University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Virginia, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Northwestern University, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Charlton', 'Affiliation': 'University of Chicago, IL, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'University of California at San Diego, California, USA.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne Université, Hôpital Pitié Salpêtrière, ICAN, Paris, France.'}, {'ForeName': 'Jossy', 'Initials': 'J', 'LastName': 'Kochuparampil', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Fischer', 'Affiliation': 'Allergan plc, CA, USA.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Vaidyanathan', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Institute of Translational & Clinical Research, Faculty of Medical Sciences, Newcastle University, Newcastle NIHR Biomedical Research Center, & Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK. Electronic address: quentin.anstee@newcastle.ac.uk.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105889']
944,30824296,A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.,"BACKGROUND


The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality.
OBJECTIVE


To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended.
DESIGN, SETTING, AND PARTICIPANTS


This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended.
RESULTS AND LIMITATIONS


The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently.
CONCLUSIONS


Findings corroborate earlier results that PSA screening significantly reduces PCa mortality, showing larger absolute benefit with longer follow-up and a reduction in excess incidence. Repeated screening may be important to reduce PCa mortality on a population level.
PATIENT SUMMARY


In this report, we looked at the outcomes from prostate cancer in a large European population. We found that repeated screening reduces the risk of dying from prostate cancer.",2019,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"['eight European countries', '182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry']",['PSA screening'],"['PCa mortality', 'rate ratio of PCa mortality', 'absolute PCa mortality', 'risk of dying from prostate cancer', 'PCa death', 'PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended', 'number needed to diagnose']","[{'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.339695,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Nelen', 'Affiliation': 'Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Lujan', 'Affiliation': 'Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Denis', 'Affiliation': 'Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rebillard', 'Affiliation': 'Urology Department, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ulf H', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Rebecka Arnsrud', 'Initials': 'RA', 'LastName': 'Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Stinesen Kollberg', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Theodorus', 'Initials': 'T', 'LastName': 'van der Kwast', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, Canada.'}, {'ForeName': 'Eveline A', 'Initials': 'EA', 'LastName': 'Heijnsdijk', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Fritz H', 'Initials': 'FH', 'LastName': 'Schröder', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.02.009']
945,31481504,A Phase I Study of the Combination of Rituximab and Ipilimumab in Patients with Relapsed/Refractory B-Cell Lymphoma.,"PURPOSE


Based on the potential for ipilimumab (I) to augment T-cell activation, we hypothesize that ipilimumab would augment the efficacy of rituximab (R) in patients with relapsed/refractory (R/R) CD20 + non-Hodgkin's lymphoma (NHL). This phase I study aimed to identify a recommended phase 2 dose, document toxicities, and preliminarily assess efficacy and potential predictive biomarkers.
PATIENTS AND METHODS


Thirty-three patients with R/R CD20 + B-cell lymphoma received R at 375 mg/m 2 weekly for 4 weeks and I at 3 mg/kg on day 1 and every 3 weeks for four doses. Responding patients went on to maintenance with each agent given every 12 weeks. To facilitate correlative analysis, the expansion phase randomized patients to simultaneous R+I versus R with I delayed 2 weeks.
RESULTS


Toxicity was manageable; no dose-limiting toxicity was observed at the doses studied. When considering the entire cohort, efficacy was modest, with an objective response rate (ORR) of 24% and median progression-free survival (PFS) of 2.6 months. However, in follicular lymphoma patients, the ORR was 58% with a median PFS of 5.6 months. The randomized comparison of R with R+I demonstrated that R+I resulted in more effective B-cell depletion (BCD). Both B-cell depletion and the ratio of CD45RA - regulatory T cell (Treg) to Treg were associated with response at all time points.
CONCLUSIONS


The combination of R+I has manageable toxicity and encouraging efficacy in R/R follicular lymphoma. The ratio of CD45RA - Tregs to total Tregs, and peripheral BCD should be studied further as potential predictors of response.",2019,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","['Thirty-three patients with R/R CD20+ B-cell lymphoma received R at 375mg/m 2  weekly for 4 weeks and', 'patients with relapsed/refractory (R/R) CD20+ NHL', 'Patients with Relapsed/Refractory B-Cell Lymphoma']",['Rituximab and Ipilimumab'],"['median progression-free survival (PFS', 'objective response rate (ORR', 'ORR', 'effective B cell depletion (BCD', 'limiting toxicity']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079731', 'cui_str': 'B-Cell Lymphomas'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",33.0,0.0214727,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Tuscano', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, California. jtuscano@ucdavis.edu.'}, {'ForeName': 'Emanual', 'Initials': 'E', 'LastName': 'Maverakis', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Groshen', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Denice', 'Initials': 'D', 'LastName': 'Tsao-Wei', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Luxardi', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Merleev', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Beaven', 'Affiliation': 'University of North Carolina Comprehensive Cancer Center, Chapel Hill, North Carolina.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Popplewell', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kirschbaum', 'Affiliation': 'Taiho Oncology, Princeton, New Jersey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Schroeder', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Newman', 'Affiliation': 'Division of Molecular Pharmacology, Department of Medical Oncology, City of Hope, Duarte, California, USA.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0438']
946,31187863,Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity.,"BACKGROUND


Dietary DHA intake among US toddlers is low. Healthy physical growth is an important objective for the clinical care of children born preterm.
OBJECTIVES


The aim of the trial was to examine the effects of supplementing toddlers born preterm with DHA and arachidonic acid (AA) for 180 d on growth and adiposity.
METHODS


Omega Tots, a randomized placebo-controlled trial, was conducted between April 2012 and March 2017. Children born at <35 wk gestation who were 10-16 mo in corrected age were assigned to receive daily oral supplements of DHA and AA (200 mg each, ""DHA + AA"") or corn oil (placebo) for 180 d. Prespecified secondary outcomes included weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage, which were measured at baseline and trial completion. Mixed-effects regression was used to compare the change in outcomes between the DHA + AA and placebo groups, controlling for baseline values.
RESULTS


Among 377 children included in the analysis (median corrected age = 15.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end. No statistically significant differences between the DHA + AA and placebo groups in growth or adiposity outcomes were observed. For instance, the change in weight-for-age z scores was 0.1 for the DHA + AA group and 0.0 for the placebo group (effect size = 0.01, P = 0.99). However, post-hoc subgroup analyses revealed a statistically significant interaction between treatment group and sex, suggesting somewhat slower linear growth for females assigned to the DHA + AA group compared with the placebo group.
CONCLUSIONS


Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo. If DHA supplementation is implemented after the first year of life, it can be expected to have no effect on short-term growth or adiposity. This trial is registered with clinicaltrials.gov as NCT02199808.",2019,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","['Toddlers Born Preterm', 'supplementing toddlers born preterm with DHA and', 'children born preterm', 'Children born at <35 wk gestation who were 10-16 mo in corrected age', '377 children included in the analysis (median corrected age\xa0=\xa015.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end', 'April 2012 and March 2017']","['daily oral supplements of DHA and AA (200 mg each, ""DHA\xa0+\xa0AA"") or corn oil (placebo', 'arachidonic acid (AA', 'placebo', 'Docosahexaenoic and Arachidonic Acid Supplementation']","['weight-for-age z scores', 'growth or adiposity outcomes', 'weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage', 'growth or adiposity']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",377.0,0.675973,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","[{'ForeName': 'Taniqua T', 'Initials': 'TT', 'LastName': 'Ingol', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': 'Schoenbaum Family Center and Crane Center for Early Childhood Research and Policy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Keith O', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Psychology, Alberta Children's Hospital Research Institute, and Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Nelin', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Sheppard', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}]",The Journal of nutrition,['10.1093/jn/nxz115']
947,31056423,"Lessons Learned and Strategies for Recruitment of Diverse, Low-income Patients into an Integrative Medical Group Visit Clinical Trial.","OBJECTIVE


Description of recruitment methods and lessons learned in a randomized controlled trial of underserved patients using an integrative medical group visits intervention.
METHODS


Comparison of the demographic characteristics of participants screened and consented to the study as well as description of recruitment methods used.
OUTCOME MEASURES


This paper examines the characteristics of patients who were eligible compared to those who were not, characteristics of patients at the different sites, and patient characteristics over time (by comparing various cohorts) based on our experiences recruiting underserved patients.
RESULTS


We screened 338 patients, with 205 (60.6%) meeting eligibility criteria and 159 patients randomized and consented. 133 patients were found ineligible, with the most common reasons being low depression scores (n = 20), manic symptoms (n = 20), and psychotic symptoms (n = 19), and alcohol use (n = 15). We found demographic differences in patients recruited by different methods and at different sites- patients referred by provider letter were older than those referred by self-referral or provider referral (mean age/SD vs. mean age/SD, p = 0.0001). For site-specific differences, patients at DH were older (53 SD = 12.3) than those at the Boston Medical Center (49 SD = 11.3) and CSHC (p = 0.048) in pair-wise comparisons. Patients at DH were also more likely to be white (25%) as compared to BMC (18%) and DH (7%), while those at CSHC were more likely to be black (70%) (p = 0.008).",2019,"For site-specific differences, patients at DH were older (53 SD = 12.3) than those at the Boston Medical Center (49 SD = 11.3) and CSHC (p = 0.048) in pair-wise comparisons.","['underserved patients using an integrative medical group visits intervention', '338 patients, with 205 (60.6%) meeting eligibility criteria and 159 patients randomized and consented', 'Comparison of the demographic characteristics of participants screened and consented to the study as well as description of recruitment methods used', 'patients who were eligible compared to those who were not, characteristics of patients at the different sites, and patient characteristics over time (by comparing various cohorts) based on our experiences recruiting underserved patients', '133 patients were found ineligible, with the most common reasons being low depression scores (n\u202f=\u202f20), manic symptoms (n\u202f=\u202f20), and psychotic symptoms (n\u202f=\u202f19), and alcohol use (n\u202f=\u202f15', 'patients recruited by different methods and at different sites- patients referred by provider letter were older than those referred by self-referral or provider referral (mean age/SD vs. mean age/SD, p\u202f=\u202f0.0001']",[],[],"[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3266254', 'cui_str': 'Referred by self (finding)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],[],133.0,0.145108,"For site-specific differences, patients at DH were older (53 SD = 12.3) than those at the Boston Medical Center (49 SD = 11.3) and CSHC (p = 0.048) in pair-wise comparisons.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gardiner', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA. Electronic address: paula.gardiner@bmc.org.'}, {'ForeName': 'Anna Sophia', 'Initials': 'AS', 'LastName': 'Lestoquoy', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'N Lily', 'Initials': 'NL', 'LastName': 'Negash', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gergen-Barnett', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Saper', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Penti', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'White', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.01.003']
948,31079993,Are Patients More Satisfied With a Balanced Total Knee Arthroplasty?,"BACKGROUND


Patient-reported outcome measures are increasingly recognized as an important tool in quantifying the clinical success of arthroplasty surgery. The aim of this study is to measure post-operative joint awareness and satisfaction in patients with and without a quantitatively balanced knee following primary total knee arthroplasty (TKA).
METHODS


In this multi-center study, a total of 318 eligible patients were assigned to one of the 2 patient groups: sensor-guided TKA or surgeon-guided TKA. In the sensor-guided group, quantitative balancing was performed according to intercompartmental tibiofemoral load measurements measured by an instrumented tibial trial component. In contrast, for the surgeon-guided group, the knees were balanced according to the surgeons' standard manual techniques while blinding the surgeon to the sensor measurements. Patients were blinded to their allocation and filled out the validated Forgotten Joint Score and 2011 Knee Society Satisfaction questionnaires at 6 weeks and 6 months. For the purposes of this study, the subjects were pooled and stratified by their state of soft tissue balance, based on the mediolateral load differential through the range of motion.
RESULTS


In the surgeon-guided group, approximately 50% of the cases yielded a quantitatively balanced knee. Significantly more balanced knees were observed in the sensor-guided group (84.0%). More importantly, for both outcome measures, the balanced group of patients reported significantly better outcomes scores.
CONCLUSION


This demonstrates that using sensor feedback during knee arthroplasty surgery results in a more reproducible procedure, resulting in a higher percentage of balanced patients who in turn demonstrate superior clinical outcomes compared to unbalanced patients.",2019,Significantly more balanced knees were observed in the sensor-guided group (84.0%).,"['patients with and without a quantitatively balanced knee following primary total knee arthroplasty (TKA', '318 eligible patients were assigned to one of the 2 patient groups']",['sensor-guided TKA or surgeon-guided TKA'],['balanced knees'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",318.0,0.0401875,Significantly more balanced knees were observed in the sensor-guided group (84.0%).,"[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Golladay', 'Affiliation': 'Department of Orthopaedic Surgery, Virginia Commonwealth University Health, Richmond, Virginia.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Bradbury', 'Affiliation': 'Department of Orthopaedic Surgery, Emory Healthcare, Atlanta, Georgia.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Illinois Bone and Joint Institute, Morton Grove, Illinois.'}, {'ForeName': 'Ivan J', 'Initials': 'IJ', 'LastName': 'Fernandez-Madrid', 'Affiliation': 'NYU Orthopaedic Surgery Associates, NYU Langone Health, New York, New York.'}, {'ForeName': 'Viktor E', 'Initials': 'VE', 'LastName': 'Krebs', 'Affiliation': 'Department of Orthopaedic Surgery, The Cleveland Clinic Foundation A41, Cleveland, Ohio.'}, {'ForeName': 'Preetesh D', 'Initials': 'PD', 'LastName': 'Patel', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Suarez', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida; Miami Orthopaedics and Sports Medicine Institute, Baptist Health South Florida, Miami, Florida.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Higuera Rueda', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida.'}, {'ForeName': 'Wael K', 'Initials': 'WK', 'LastName': 'Barsoum', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.03.036']
949,31676314,The SAFE-trial: Safe surgery for glioblastoma multiforme: Awake craniotomy versus surgery under general anesthesia. Study protocol for a multicenter prospective randomized controlled trial.,"BACKGROUND


Surgery of GBM nowadays is usually performed under general anesthesia (GA) and resections are often not as aggressive as possible, due to the chance of seriously damaging the patient with a rather low life expectancy. A surgical technique optimizing resection of the tumor in eloquent areas but preventing neurological deficits is necessary to improve survival and quality of life in these patients. Awake craniotomy (AC) with the use of cortical and subcortical stimulation has been widely implemented for low-grade glioma resections (LGG), but not yet for GBM. AC has shown to increase resection percentage and preserve quality of life in LGG and could thus be of important value in GBM surgery.
METHODS/DESIGN


This study is a prospective, multicenter, randomized controlled trial (RCT). Consecutive patients with a glioblastoma in or near eloquent areas (Sawaya grading II/III) will be 1:1 randomized to awake craniotomy or craniotomy under general anesthesia. 246 patients will be included in neurosurgical centers in the Netherlands and Belgium. Primary end-points are: 1) Postoperative neurological morbidity and 2) Proportion of patients with gross-total resections. Secondary end-points are: 1) Health-related quality of life; 2) Progression-free survival (PFS); 3) Overall survival (OS) and 4) Frequency and severity of Serious Adverse Effects in each group. Also, a cost-benefit analysis will be performed. All patients will receive standard adjuvant treatment with concomitant chemoradiotherapy.
DISCUSSION


This RCT should demonstrate whether AC is superior to craniotomy under GA on neurological morbidity, extent of resection and survival for glioblastoma resections in or near eloquent areas.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03861299 Netherlands Trial Register (NTR): NL7589.",2020,"AC has shown to increase resection percentage and preserve quality of life in low grade glioma (LGG) and could be of important value in the surgery of GBM.
","[""Glioblastoma Multiforme (GBM) or astrocytoma's grade IV (WHO"", 'Consecutive patients with a glioblastoma in or near eloquent areas (Sawaya grading II/III', '123 patients in each treatment arm are required', '246 patients in 4\u202fyears', 'patients with GBM', '246 patients in 4 neurosurgical centers in the Netherlands and 1 neurosurgical center in Belgium']","['Awake craniotomy versus craniotomy under general anaesthesia', 'concomitant temozolamide and radiation therapy and standard follow up', 'awake craniotomy or craniotomy under general anaesthesia with an 1:1 allocation ratio', 'Awake craniotomy (AC']","['survival', '1) Proportion of patients with NIH Stroke Scale (NIHSS) deterioration', 'survival and quality of life', '2) Progression-free survival (PFS', '1) Health related quality of life (HRQoL', 'Overall survival (OS', '4) Frequency and severity of Serious Adverse Effects', 'postoperative MRI', 'total NIHSS score']","[{'cui': 'C1621958', 'cui_str': 'Glioblastoma Multiforme'}, {'cui': 'C0004114', 'cui_str': 'Astroglioma'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",246.0,0.205721,"AC has shown to increase resection percentage and preserve quality of life in low grade glioma (LGG) and could be of important value in the surgery of GBM.
","[{'ForeName': 'Jasper K W', 'Initials': 'JKW', 'LastName': 'Gerritsen', 'Affiliation': 'Erasmus Medical Center Rotterdam, Department of Neurosurgery, The Netherlands. Electronic address: j.gerritsen@erasmusmc.nl.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Klimek', 'Affiliation': 'Erasmus Medical Center Rotterdam, Department of Anesthesiology, The Netherlands.'}, {'ForeName': 'Clemens M F', 'Initials': 'CMF', 'LastName': 'Dirven', 'Affiliation': 'Erasmus Medical Center Rotterdam, Department of Neurosurgery, The Netherlands.'}, {'ForeName': 'Esther Oomen-de', 'Initials': 'EO', 'LastName': 'Hoop', 'Affiliation': 'Erasmus Medical Center Rotterdam, Department of Biostatistics, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Wagemakers', 'Affiliation': 'University Medical Center Groningen, Department of Neurosurgery, The Netherlands.'}, {'ForeName': 'Geert Jan M', 'Initials': 'GJM', 'LastName': 'Rutten', 'Affiliation': 'Elisabeth-Tweesteden Hospital Tilburg, Department of Neurosurgery, The Netherlands.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Kloet', 'Affiliation': 'Haaglanden Medical Center Den Haag, Department of Neurosurgery, The Netherlands.'}, {'ForeName': 'Giorgio G', 'Initials': 'GG', 'LastName': 'Hallaert', 'Affiliation': 'University Hospital Gent, Department of Neurosurgery, Belgium.'}, {'ForeName': 'Arnaud J P E', 'Initials': 'AJPE', 'LastName': 'Vincent', 'Affiliation': 'Erasmus Medical Center Rotterdam, Department of Neurosurgery, The Netherlands.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105876']
950,31504690,A 4-d Water Intake Intervention Increases Hydration and Cognitive Flexibility among Preadolescent Children.,"BACKGROUND


Hydration effects on cognition remain understudied in children. This is concerning since a large proportion of US children exhibit insufficient hydration.
OBJECTIVE


This study investigated the effects of water intake on urinary markers of hydration and cognition among preadolescents.
METHODS


A 3-intervention crossover design was used among 9- to 11-y-olds [n = 75 (43 males, 32 females); 58.2 ± 28.5 BMI percentile]. Participants maintained their water intake [ad libitum (AL)] or consumed high (2.5 L/d) or low (0.5 L/d) water for 4 d. The primary outcomes were performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively. Secondary outcomes included urine hydration indices [i.e., color, urine specific gravity (USG), osmolality] assessed using 24-h urine collected during day 4 of each intervention. Repeated-measures ANOVAs were used to assess intervention effects.
RESULTS


There was a significant difference in hydration across all 3 interventions. Urine color during the low intervention [median (IQR): 6 (2)] was greater than during AL [5 (2)], and both were greater than during the high intervention [18 (0)] (all P ≤ 0.01). Similarly, osmolality [low (mean ± SD): 912 ± 199 mOsmol/kg, AL: 790 ± 257.0 mOsmol/kg, high: 260 ± 115 mOsmol/kg] and USG [low (mean ± SD): 1.023 ± 0.005, AL: 1.020 ± 0.007, high: 1.005 ± 0.004] during the low intervention were greater during AL, and both were greater than during the high intervention (all P ≤ 0.01). USG and osmolality AL values were related to switch task measures (β: 0.21 to -0.31, P < 0.05). Benefits of the high intervention were observed during the switch task, whereby participants exhibited 34% lower working memory cost relative to the low intervention. No significant changes in cognition were observed for the flanker and go/no-go tasks.
CONCLUSIONS


The water intervention improved urinary markers of hydration and had selective benefits during task switching. Furthermore, children's cognitive flexibility selectively benefits from greater habitual hydration and water intake. This study is registered at clinicaltrials.gov as NCT02816450.",2019,"The primary outcomes were performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively.","['Preadolescent Children', 'children', '75 (43 males, 32 females); 58.2\xa0±\xa028.5 BMI percentile', '9- to 11-y-olds [n\xa0']","['water intake', '4-d Water Intake Intervention', 'water intake [ad libitum (AL)] or consumed high (2.5 L/d) or low (0.5 L/d) water for 4 d']","['performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively', 'urinary markers of hydration', 'USG and osmolality AL values', 'osmolality [low (mean ± SD): 912\xa0±\xa0199 mOsmol/kg, AL', 'cognition', 'Hydration and Cognitive Flexibility', 'Urine color', 'urine hydration indices [i.e., color, urine specific gravity (USG), osmolality] assessed using 24-h urine collected']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439353', 'cui_str': 'mosmol/kg'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042037'}, {'cui': 'C0587361', 'cui_str': 'Specific gravity of urine (finding)'}]",,0.0263834,"The primary outcomes were performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively.","[{'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Westfall', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Alicia R', 'Initials': 'AR', 'LastName': 'Jones', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Macie A', 'Initials': 'MA', 'LastName': 'Sinn', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Jeanne H', 'Initials': 'JH', 'LastName': 'Bottin', 'Affiliation': 'Health, Hydration, and Nutrition Science Department, Danone Research, Palaiseau, France.'}, {'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Perrier', 'Affiliation': 'Health, Hydration, and Nutrition Science Department, Danone Research, Palaiseau, France.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz206']
951,30975478,"Posterior Hip Precautions Do Not Impact Early Recovery in Total Hip Arthroplasty: A Multicenter, Randomized, Controlled Study.","BACKGROUND


Posterior hip precautions have been routinely prescribed to decrease dislocation rates. The purpose of this study was to determine whether the absence of hip precautions improved early recovery after total hip arthroplasty via the posterolateral approach.
METHODS


Patients undergoing total hip arthroplasty via the posterolateral approach at 3 centers were enrolled. Patients meeting the selection criteria were randomized to standard hip precautions (SHP) or no hip precautions (NHP) for 6 weeks following surgery. HOOS Jr, Health State visual analog score, and rate of pain scores were recorded preoperatively and in subsequent postoperative visits; dislocation episodes were also noted. Standard statistical analysis was performed.
RESULTS


From 2016 to 2017, 159 patients were randomized to SHP and 154 patients were randomized to NHP. Controlling for the center at which the surgery was performed, the only difference in outcome scores between the 2 groups was at 2 weeks; the NHP group had a lower HOOS Jr score when compared to the SHP group (P = .03). There was no difference in outcome scores at any other time points when compared to preoperative assessments. In the SHP group, there were 2 recorded dislocations (1.3%) and 1 in the NHP group (0.7%; P = .62).
CONCLUSION


In this multicenter, randomized, controlled study, the absence of hip precautions in the postoperative period did not improve subjective outcomes which may be explained by the self-limiting behavior of NHP patients. Furthermore, with the numbers available for the study, there was no difference in the rate of dislocation between the 2 groups.",2019,There was no difference in outcome scores at any other time points when compared to preoperative assessments.,"['Patients meeting the selection criteria', 'Total Hip Arthroplasty', 'Patients undergoing total hip arthroplasty via the posterolateral approach at 3 centers were enrolled', 'From 2016 to 2017, 159 patients were randomized to SHP and 154 patients']","['NHP', 'standard hip precautions (SHP) or no hip precautions (NHP']","['HOOS Jr score', 'dislocation rates', 'rate of dislocation', 'HOOS Jr, Health State visual analog score, and rate of pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",159.0,0.0786813,There was no difference in outcome scores at any other time points when compared to preoperative assessments.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Dietz', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Adam E', 'Initials': 'AE', 'LastName': 'Klein', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Brock A', 'Initials': 'BA', 'LastName': 'Lindsey', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Duncan', 'Affiliation': 'Department of Orthopaedics, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Eicher', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Gillig', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Smith', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}, {'ForeName': 'G Daxton', 'Initials': 'GD', 'LastName': 'Steele', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.057']
952,31786203,Six-year contraceptive efficacy and continued safety of a levonorgestrel 52 mg intrauterine system.,"OBJECTIVE


To assess 6-year contraceptive efficacy and safety of a levonorgestrel 52 mg intrauterine system (IUS).
STUDY DESIGN


We assessed pregnancy rates through 72 months in women aged 16-35 years at enrollment and safety in all participants (aged 16-45 years, n = 1751) in an ongoing 10-year phase-3 trial.
RESULTS


Over six years, nine pregnancies occurred (none in year 6) for a life-table pregnancy rate of 0.87 (95% CI 0.44-1.70). Adverse event rates remain low through 6 or more years of use. Two expulsions occurred in year 6.
CONCLUSION


This levonorgestrel 52 mg IUS is a highly effective and safe contraceptive over 6 years of use.
IMPLICATIONS


The levonorgestrel 52 mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.",2020,The levonorgestrel 52mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.,"['women aged 16-35 years at enrollment and safety in all participants (aged 16-45 years, n=1751) in an ongoing 10-year phase-3 trial']","['Levonorgestrel 52mg Intrauterine System', 'levonorgestrel 52mg intrauterine system (IUS', 'levonorgestrel 52mg IUS']","['pregnancy rates', '6-year contraceptive efficacy and safety', '6-year contraceptive efficacy', 'life-table pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C0937459', 'cui_str': 'levonorgestrel 52 MG 5 Year Intrauterine System'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023683', 'cui_str': 'Life Tables'}]",,0.351592,The levonorgestrel 52mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.,"[{'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Keder', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Gangestad', 'Affiliation': 'Department of Reproductive Biology, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Stephanie B', 'Initials': 'SB', 'LastName': 'Teal', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Andrea I', 'Initials': 'AI', 'LastName': 'Olariu', 'Affiliation': 'Medicines360, San Francisco, CA, USA.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA. Electronic address: mdcreinin@ucdavis.edu.'}]",Contraception,['10.1016/j.contraception.2019.10.010']
953,30088226,The Effect of Counseling on Breast Cancer Awareness in Rural Iranian Women: a Randomized Controlled Clinical Trial.,"In a community such as Iran where late presentation is predominant and the majority of breast cancer patients are diagnosed at advanced stages of the disease, there is an urgent need for improving the level of awareness about breast cancer and early detection measures. Given that rural residents are at higher risk for late diagnosis of breast cancer because they have less education, income, and access to advanced screening technologies, this study was conducted to determine the effect of counseling on breast cancer awareness of rural Iranian women. This randomized clinical trial was conducted on 60 rural women from the Abish Ahmad area in northwestern Iran in 2017. The randomized cluster method was used for sampling. From 20 rural health houses and centers, about one third were selected randomly. From the six selected clusters, three were randomly allocated as the control group and three as the intervention group. Using convenience sampling, 30 women between the ages of 40 and 69 were selected from the control group and 30 from the intervention group. The intervention group attended six group counseling sessions. Data was gathered using a demographic and obstetrical information questionnaire and breast cancer awareness measures. The chi-square, independent t test and ANCOVA by controlling for the baseline scores were used to analyze the data. After counseling, the mean knowledge about breast cancer score was significantly higher in the intervention group than in the control group (adjusted mean difference, 17.02; confidence interval (CI) 95%, 15.44 to 18.59; p < 0.001). The mean barriers to breast cancer screening score showed a significant decrease in the intervention group compared to the control group (AMD, - 1.74; 95% CI - 3.12 to - 0.36, p < 0.001). After intervention, the frequency of breast self-exam showed a significant difference between groups (p < 0.001); but for confidence about noticing breast changes, no significant difference was observed between groups (p = 0.08). Group counseling had a significant effect on enhancing breast cancer awareness of rural Iranian women, except for confidence about noticing breast changes.",2019,"After intervention, the frequency of breast self-exam showed a significant difference between groups (p < 0.001); but for confidence about noticing breast changes, no significant difference was observed between groups (p = 0.08).","['Rural Iranian Women', '60 rural women from the Abish Ahmad area in northwestern Iran in 2017', '30 women between the ages of 40 and 69 were selected from the control group and 30 from the intervention group', 'rural Iranian women', 'From 20 rural health houses and centers, about one third were selected randomly']",[],"['enhancing breast cancer awareness', 'mean barriers to breast cancer screening score', 'frequency of breast self-exam', 'mean knowledge about breast cancer score', 'Breast Cancer Awareness']","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035959'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",30.0,0.0471122,"After intervention, the frequency of breast self-exam showed a significant difference between groups (p < 0.001); but for confidence about noticing breast changes, no significant difference was observed between groups (p = 0.08).","[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Alizadeh Sabeg', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Mehrabi', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Nourizadeh', 'Affiliation': 'Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical sciences, Tabriz, Iran. rnourizadeh@gmail.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Poursharifi', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1411-z']
954,31776620,Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


The objective was to compare the effect of antibiotics versus no antibiotics prophylaxis per-operatively on the frequency of urinary tract infection (UTI) following mid-urethral sling application to treat stress or mixed urinary incontinence.
METHODS


This study was designed as a multicenter prospective randomized trial. Women were included from eight centers in three countries. Women were aged under 60 years and had objectively verified stress urinary incontinence. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either antibiotics or no antibiotics. UTI was defined in accordance with the Centers for Disease Control (CDC) criteria for symptomatic UTI. Women were followed up at 3, 12, and 36 months. This was part of a trial comparing subjective cure rate in relation to application of Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings.
RESULTS


The main outcome was to evaluate if per-operative antibiotics had any impact on UTI following sling surgery. In total, 305 women were randomized (158 [52%] to antibiotics and 147 [48%] to no antibiotics). Demographic data disclosed no differences between the two groups. The trial did not show any difference between the two groups regarding the frequency of postoperative UTI. Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs. Per-operative antibiotics had no influence on the frequency of mesh erosions or any other complication.
CONCLUSIONS


Our trial does not suggest any beneficial effect of per-operative antibiotics on the risk of post-operative UTIs.",2020,Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs.,"['Women with mixed urinary incontinence', 'urinary incontinence', 'Women were aged under 60\xa0years and had objectively verified stress urinary incontinence', 'Women were included from eight centers in three countries', '305 women']","['mid-urethral sling surgery', 'antibiotics', 'per-operative antibiotics', 'Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings']","['frequency of urinary tract infection (UTI', 'urinary tract infection rate', 'frequency of postoperative UTI', 'frequency of mesh erosions']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0869256', 'cui_str': 'Mixed incontinence (finding)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}]","[{'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}]",305.0,0.165136,Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rudnicki', 'Affiliation': 'Department of Obstetrics and Gynecology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense, Denmark. mr@rsyd.dk.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Jakobsson', 'Affiliation': 'Center for Primary Healthcare Research, Clinical Research Center, Box 50332, 202 13, Malmö, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Teleman', 'Affiliation': 'Department of Obstetrics and Gynecology, Skane University Hospital, Lund University, Klinikgatan 12, 221 85, Lund, Sweden.'}]",International urogynecology journal,['10.1007/s00192-019-04156-9']
955,31623760,Sex-Specific Thresholds of High-Sensitivity Troponin in Patients With Suspected Acute Coronary Syndrome.,"BACKGROUND


Major disparities between women and men in the diagnosis, management, and outcomes of acute coronary syndrome are well recognized.
OBJECTIVES


The aim of this study was to evaluate the impact of implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome.
METHODS


Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals. Myocardial injury was defined as high-sensitivity cardiac troponin I concentration >99th centile of 16 ng/l in women and 34 ng/l in men. The primary outcome was recurrent myocardial infarction or cardiovascular death at 1 year.
RESULTS


A total of 48,282 patients (47% women) were included. Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%. Following implementation, women with myocardial injury remained less likely than men to undergo coronary revascularization (15% vs. 34%) and to receive dual antiplatelet (26% vs. 43%), statin (16% vs. 26%), or other preventive therapies (p < 0.001 for all). The primary outcome occurred in 18% (369 of 2,072) and 17% (488 of 2,919) of women with myocardial injury before and after implementation, respectively (adjusted hazard ratio: 1.11; 95% confidence interval: 0.92 to 1.33), compared with 18% (370 of 2,044) and 15% (513 of 3,325) of men (adjusted hazard ratio: 0.85; 95% confidence interval: 0.71 to 1.01).
CONCLUSIONS


Use of sex-specific thresholds identified 5 times more additional women than men with myocardial injury. Despite this increase, women received approximately one-half the number of treatments for coronary artery disease as men, and outcomes were not improved. (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome [High-STEACS]; NCT01852123).",2019,Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%.,"['Patients', 'women', '48,282 patients (47% women) were included', 'women by 42% and in men by 6', '99th centile of 16', 'women and men with suspected acute coronary syndrome', 'Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals']",['implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds'],"['recurrent myocardial infarction or cardiovascular death', 'coronary revascularization', 'myocardial injury', 'high-sensitivity cardiac troponin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]",,0.486415,Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%.,"[{'ForeName': 'Kuan Ken', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Amy V', 'Initials': 'AV', 'LastName': 'Ferry', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Strachan', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Dorien M', 'Initials': 'DM', 'LastName': 'Kimenai', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands; Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Steven J R', 'Initials': 'SJR', 'LastName': 'Meex', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands; Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Findlay', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cruickshank', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Emergency Medicine Research Group Edinburgh, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Collinson', 'Affiliation': ""Departments of Clinical Blood Sciences and Cardiology, St. George's, University Hospitals NHS Trust and St. George's University of London, London, United Kingdom.""}, {'ForeName': 'Fred S', 'Initials': 'FS', 'LastName': 'Apple', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Hennepin County Medical Center & University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Donogh', 'Initials': 'D', 'LastName': 'Maguire', 'Affiliation': 'Emergency Medicine Department, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tuck', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Keerie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: nick.mills@ed.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.082']
956,31782023,"Acute effects of photobiomodulation therapy and magnetic field on functional mobility in stroke survivors: a randomized, sham-controlled, triple-blind, crossover, clinical trial.","Identify the optimal energy delivered with a single application of the combination of photobiomodulation therapy (PBMT) combining different light sources (low-level laser therapy-LLLT and light emitting diode therapy-LEDT) and static magnetic field (sMF) in order to determine the acute effects on functional mobility of stroke survivors. Was conducted a randomized, placebo-controlled, crossover, triple-blind, clinical trial (RCT). Twelve patients were recruited, however ten concluded the study, they were randomly treated with four PBMT/sMF energies (sham-0 J, 10 J, 30 J, and 50 J per site irradiated), with 1-week interval washout between treatments. PBMT/sMF were administered after the pre-intervention (baseline) evaluation and the total energy delivered per site at each treatment was determined based on the results of the randomization procedure. PBMT/sMF were administered in direct contact with the skin and applied with slight pressure to nine sites on the knee extensors, six sites on the knee flexors, and two sites on the plantar flexors' muscles in both lower limbs (bilaterally). The primary outcome measure was the 6-min walk test (6MWT) and the secondary outcome was the Timed Up and Go (TUG) test. Significant improvements were found in the 6MWT test using a total energy of 30 J per site compared with sham (0 J) (p < 0.05) and compared with the baseline evaluation (p < 0.01). And in the TUG test significant improvements were also found using a total energy per site of 30 J per site compared to sham (0 J) and baseline (p < 0.05). PBMT with different light sources (laser and LEDs) and wavelengths in combination with sMF with a total energy per site of 30 J has positive acute effects on functional mobility in stroke survivors.",2020,Significant improvements were found in the 6MWT test using a total energy of 30 J per site compared with sham (0 J) (p < 0.05) and compared with the baseline evaluation (p < 0.01).,"['Twelve patients were recruited, however ten concluded the study, they were randomly treated with four', 'stroke survivors']","['PBMT with different light sources (laser and LEDs', 'photobiomodulation therapy and magnetic field', 'placebo', 'PBMT/sMF', 'photobiomodulation therapy (PBMT) combining different light sources (low-level laser therapy-LLLT and light emitting diode therapy-LEDT) and static magnetic field (sMF']","['functional mobility', '6MWT test using a total energy', '6-min walk test (6MWT) and the secondary outcome was the Timed Up and Go (TUG) test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0563533', 'cui_str': 'Magnetic Fields'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}]",10.0,0.124809,Significant improvements were found in the 6MWT test using a total energy of 30 J per site compared with sham (0 J) (p < 0.05) and compared with the baseline evaluation (p < 0.01).,"[{'ForeName': 'Heliodora Leão', 'Initials': 'HL', 'LastName': 'Casalechi', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Arislander Jonathan Lopes', 'Initials': 'AJL', 'LastName': 'Dumont', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil. arislanderlg@gmail.com.'}, {'ForeName': 'Luiz Alfredo Braun', 'Initials': 'LAB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physiotherapy of the Guairacá College and the Centro-Oeste State University (UNICENTRO), Guarapuava, Parana, Brazil.'}, {'ForeName': 'Paulo Roberto Vicente', 'Initials': 'PRV', 'LastName': 'de Paiva', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Caroline Dos Santos Monteiro', 'Initials': 'CDSM', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Paulo de Tarso Camillo', 'Initials': 'PTC', 'LastName': 'de Carvalho', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Claudia Santos', 'Initials': 'CS', 'LastName': 'Oliveira', 'Affiliation': 'Health Sciences Program, Santa Casa School of Medical Sciences of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02898-y']
957,30116989,The Effects of the Training Program and Counseling Program Given to Women Who Underwent a Mastectomy and Spouses.,"Following breast cancer treatment, many families are negatively affected following the treatment for breast cancer of their women members. This study focused on assessing the effects of the training program and counseling program given to women who underwent a mastectomy and their spouses. Sixty women and 60 spouses were recruited for this study. The women in the experimental group and their spouses were provided with a four-session training program, once a week. Following this training, a 3-month follow-up and counseling were given and an assessment made. There was significant difference between average post-test scores of spouses in the experimental and control groups, in terms of problem solving (p = .003), communication (p = .033), and roles (p = .000) dimensions of family assessment device (FAD). Noting that women in the experimental and control groups demonstrated significant differences among average post-test scores in terms of role emotional (p = .045) and mental health (p = .017) dimensions of Quality of Life Scale (SF-36), a significant difference existed among average post-test scores of spouses in the experimental and control groups in terms of general health (p = .017), role physical (p = .011), role emotional (p = .003), and mental health (p = .005) dimensions of Quality of Life Scale. These results indicated that training and counseling program provided to this population produced positive effects upon family functioning and quality of life.",2019,"There was significant difference between average post-test scores of spouses in the experimental and control groups, in terms of problem solving (p = .003), communication (p = .033), and roles (p = .000) dimensions of family assessment device (FAD).","['Sixty women and 60 spouses', 'women who underwent a mastectomy and their spouses']","['training program and counseling program', 'Training Program and Counseling Program Given to Women']","['mental health', 'family functioning and quality of life', 'role physical', 'general health', 'Quality of Life Scale', 'Quality of Life Scale (SF-36', 'role emotional']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",60.0,0.0206622,"There was significant difference between average post-test scores of spouses in the experimental and control groups, in terms of problem solving (p = .003), communication (p = .033), and roles (p = .000) dimensions of family assessment device (FAD).","[{'ForeName': 'Bahar Kefeli', 'Initials': 'BK', 'LastName': 'Çol', 'Affiliation': 'Recep Tayyip Erdogan University Guneysu Vocational School of Physical Theraphy and Rehabilitation, Rize, Turkey. bahar_kefeli@hotmail.com.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Kılıç', 'Affiliation': 'Nursing Faculty, Public Health Nursing Department, Atatürk University, Erzurum, Turkey. dilekk@atauni.edu.tr.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1410-0']
958,31678837,The impact of plain packaging and health warnings on consumer appeal of cannabis products.,"BACKGROUND


Canada implemented 'plain packaging' regulations and rotating health warnings for cannabis products upon legalizing non-medical cannabis in October 2018. Plain packaging and health warnings are effective policy measures for reducing appeal of tobacco products; however, there is little evidence in the cannabis domain.
METHODS


An experimental task was conducted as part of the online International Cannabis Policy Study. Participants aged 16-65 from Canada (n = 9987) and US states with 'legal' (n = 7376) and 'illegal' (n = 9682) recreational cannabis were randomly assigned to see one of 18 cannabis product images. Outcomes were product appeal (0 = Not at all appealing, 10 = Very appealing) and perceived youth orientation (4 age groups). A 3 (branding: full branding, brand logo only, or plain black packaging) x 2 (health warning labels: present or absent) x 3 (product type: edible gummies, cannabis oil, or pre-rolled joints) factorial design was used.
RESULTS


Compared to plain packaging or a brand logo, packages with full branding were considered more appealing and more likely to be youth-oriented (p < 0.001). Products with health warnings were considered less appealing than packages without warnings (p < 0.001). Edible gummies were perceived as more appealing and more likely to be youth-oriented than pre-rolled joints and cannabis oil (p < 0.001). Additionally, edible gummies were rated as significantly more appealing by 16-18 and 19-35-year-olds than by older adults (p < 0.02 for all).
CONCLUSIONS


Comprehensive health warnings and 'plain packaging' regulations may reduce the appeal of cannabis products in a legal market. The results also provide empirical evidence that edible gummies are perceived to appeal to youth.",2019,Products with health warnings were considered less appealing than packages without warnings (p < 0.001).,"[""Participants aged 16-65 from Canada (n\u202f=\u202f9987) and US states with 'legal' (n\u202f=\u202f7376) and 'illegal' (n\u202f=\u202f9682) recreational cannabis""]","['A 3 (branding: full branding, brand logo only, or plain black packaging', 'plain packaging and health warnings']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030176', 'cui_str': 'Packaging'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.0585123,Products with health warnings were considered less appealing than packages without warnings (p < 0.001).,"[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, N2L 3G1, Canada. Electronic address: samantha.goodman@uwaterloo.ca.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Leos-Toro', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, N2L 3G1, Canada. Electronic address: cesar.leos-toro@uwaterloo.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, N2L 3G1, Canada. Electronic address: dhammond@uwaterloo.ca.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107633']
959,31765659,Androstadienone resulted in a rightward shift of women's preference for sexually dimorphic male faces across the continuum of femininity-masculinity.,"As a derivative of testosterone, androstadienone (AND) can influence human psychological and physiological states. To explore the influence of AND on women's preferences for male sexual dimorphic faces in a mate-choice context, we asked 52 females in the luteal phase to choose one from four sexual dimorphic male faces in a long-term and short-term context while inhaling 250 μm of AND or a placebo odor on two consecutive days. Results revealed that participants had a greater and lesser preference for the +30% masculinized and 60% feminized faces, respectively, while inhaling AND, as compared to when inhaling the placebo. The AND intervention resulted in a rightward shift of the women's preference for male sexual dimorphic faces across the continuum of femininity-masculinity. The current findings highlight that AND may influence women's preference for male sexually dimorphic faces in a mate-choice context.",2020,The AND intervention resulted in a rightward shift of the women's preference for male sexual dimorphic faces across the continuum of femininity-masculinity.,"[""women's preferences for male sexual dimorphic faces in a mate-choice context, we asked 52 females in the luteal phase to choose one from four sexual dimorphic male faces in a long-term and short-term context while inhaling 250\u202fμm of AND or a placebo odor on two consecutive days""]","['testosterone, androstadienone (AND', 'Androstadienone']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205220', 'cui_str': 'Dimorphic (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",[],,0.0840548,The AND intervention resulted in a rightward shift of the women's preference for male sexual dimorphic faces across the continuum of femininity-masculinity.,"[{'ForeName': 'Caoyuan', 'Initials': 'C', 'LastName': 'Niu', 'Affiliation': 'Key Laboratory of Cognition and Personality (Ministry of Education), Southwest University, Chongqing, China; Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Key Laboratory of Cognition and Personality (Ministry of Education), Southwest University, Chongqing, China; Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: lijuntrue@163.com.'}]",Hormones and behavior,['10.1016/j.yhbeh.2019.104635']
960,31743793,The Nutritious Eating with Soul (NEW Soul) Study: Study design and methods of a two-year randomized trial comparing culturally adapted soul food vegan vs. omnivorous diets among African American adults at risk for heart disease.,"BACKGROUND


Previous research has found that African American (AA) vegetarians/vegans have a significantly lower body mass index and risk of hypertension compared to omnivores.
OBJECTIVES


The Nutritious Eating with Soul (NEW Soul) study partnered with local soul food restaurants/chefs to deliver two behavioral nutrition interventions to AA adults. NEW Soul examines the impact of two different culturally tailored diets (vegan and omnivorous low-fat) on changes in risk factors for cardiovascular disease (CVD).
METHODS


AA adults with overweight or obesity are recruited from the community in the Midlands of South Carolina. Eligible participants are randomized to follow one of two different culturally-adapted, soul food diets: a vegan diet emphasizing minimally-processed whole foods from plants or a low-fat omnivorous diet. Participants attend weekly group classes for the first six months, bi-weekly for the next six months, and monthly meetings for the last year. In addition to face-to-face content, participants also have access to private Facebook groups for their diet, podcasts, and online newsletters starting at six months. Primary outcomes include changes in body weight and CVD risk factors (lipids, blood pressure, glucose, and insulin) at 12 months. Secondary outcomes include changes in dietary intake. Participants complete assessments at baseline and at months 6, 12, and 24.
CONCLUSIONS


The NEW Soul study is an innovative intervention aimed at improving dietary intake while maintaining traditional AA cultural food choices. Primary outcomes are expected by 2021.",2020,"Primary outcomes include changes in body weight and CVD risk factors (lipids, blood pressure, glucose, and insulin) at 12 months.","['AA adults with overweight or obesity are recruited from the community in the Midlands of South Carolina', 'African American adults at risk for heart disease', 'Eligible participants']","['culturally adapted soul food vegan vs. omnivorous diets', 'culturally tailored diets (vegan and omnivorous low-fat', 'vegan diet emphasizing minimally-processed whole foods from plants or a low-fat omnivorous diet']","['changes in body weight and CVD risk factors (lipids, blood pressure, glucose, and insulin', 'changes in dietary intake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2987738', 'cui_str': 'Vegan'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0344353', 'cui_str': 'Vegan dietary (finding)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0453870', 'cui_str': 'Whole food (substance)'}, {'cui': 'C0032098', 'cui_str': 'Plants'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0460591,"Primary outcomes include changes in body weight and CVD risk factors (lipids, blood pressure, glucose, and insulin) at 12 months.","[{'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA. Electronic address: brie@sc.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': 'School of Medicine, University of South Carolina, 6439 Garners Ferry Rd, Columbia, SC 29209, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Rush University, Division of Cardiology, Department of Internal Medicine, Rush Medical College, 1725 W. Harrison St., Suite 1159, Chicago, IL 60612, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Davey', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105897']
961,31200629,Dynamic scapular recognition exercise improves scapular upward rotation and shoulder pain and disability in patients with adhesive capsulitis: a randomized controlled trial.,"BACKGROUND


Examine the ability of a dynamic scapular recognition exercise to improve scapular upward rotation and decrease shoulder pain and disability in patients with adhesive capsulitis of the shoulder.
METHODS


A test-retest randomized controlled study design was used. A total of sixty-six patients with unilateral adhesive capsulitis were equally divided into two groups. The study group received a dynamic scapular recognition exercise using a wireless biofeedback system, while the control group received placebo treatment in the form of active range-of-motion (ROM) exercises of the sound upper limb. A digital inclinometer was used to measure the scapular upward rotation and ROM of the shoulder joint, and the Shoulder Pain and Disability Index (SPADI) was used to measure the shoulder pain and disability.
RESULTS


Study results showed that after two weeks, there were statistically significant differences between the study and control groups in scapular upward rotation and shoulder flexion and abduction (P < .05) and nonsignificant differences in shoulder external rotation and SPADI (P > .05). After two and six months, there were statistically significant differences between study and control groups in scapular upward rotation; shoulder flexion, abduction and external rotation; and SPADI scores (P < .05).
CONCLUSION


This study showed that a dynamic scapular recognition exercise significantly improves scapular upward rotation and the ROM of shoulder flexion and abduction after two weeks. At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores. These improvements persisted for six months after the performance of this exercise.",2020,"At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores.","['A total of sixty-six patients with unilateral adhesive capsulitis', 'patients with adhesive capsulitis', 'patients with adhesive capsulitis of the shoulder']","['Dynamic scapular recognition exercise', 'dynamic scapular recognition exercise', 'dynamic scapular recognition exercise using\xa0a\xa0wireless biofeedback system, while the control group received placebo treatment in the form of active range-of-motion (ROM) exercises of the sound upper limb']","['shoulder pain and disability', 'scapular upward rotation and shoulder flexion and abduction', 'shoulder external rotation and SPADI', 'scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores', 'scapular upward rotation and ROM of the shoulder joint,\xa0and the Shoulder Pain and Disability Index (SPADI', 'scapular upward rotation and the ROM of shoulder flexion and abduction', 'scapular upward rotation; shoulder flexion, abduction and external rotation; and SPADI scores', 'scapular upward rotation and shoulder pain and disability']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0179310', 'cui_str': 'Biofeedback system'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise (regime/therapy)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037009', 'cui_str': 'Glenohumeral Joint'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",66.0,0.0736383,"At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores.","[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign , Champaign, IL, USA.'}, {'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign , Champaign, IL, USA.'}, {'ForeName': 'Wadida H', 'Initials': 'WH', 'LastName': 'El Sayed', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University , Giza Egypt.'}, {'ForeName': 'Mohamed E Abdel', 'Initials': 'MEA', 'LastName': 'Wanis', 'Affiliation': 'Department of Orthopedic, Faculty of Medicine, Suhag University , Sohag, Egypt.'}, {'ForeName': 'Abeer A', 'Initials': 'AA', 'LastName': 'Yamany', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University , Giza Egypt.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1622896']
962,30035582,A latent transition analysis of a cluster randomized controlled trial for drug use prevention.,"OBJECTIVE


The objective of the study was to evaluate the impact of #Tamojunto, a Brazilian adaptation of the Unplugged prevention program, on patterns of drug use among adolescents and to characterize their trajectories of drug use over time.
METHOD


An in-cluster randomized controlled trial was conducted in 2014-2015 with 2 parallel arms (intervention and control). The intervention group attended 12 weekly classes of the #Tamojunto intervention. The control schools did not offer a prevention program. The target population was students attending seventh and eighth grades. The primary dichotomous outcome measures were use of drugs (any alcohol use, binge drinking, tobacco, marijuana, inhalants, and cocaine) in the past year assessed using a questionnaire before intervention and in 2 waves of follow-up (9 and 21 months).
RESULTS


A latent transition analysis in 6,391 students from 72 public schools in 6 Brazilian cities revealed 3 distinct patterns of drug use behavior: abstainers/low users (81.54% at baseline, 70.61% after 21 months), alcohol users/binge drinkers (16.65% at baseline, 21.45% after 21 months), and polydrug users (1.80% at baseline, 7.92% after 21 months). No differences in the probabilities of transitions between these drug use patterns were found between the intervention and control groups. The most likely trajectory was no transition between patterns, regardless of the intervention and baseline pattern.
CONCLUSIONS


The intervention was not successful in changing adolescent drug use patterns over time, showing that the components of the Brazilian adaptation of the Unplugged prevention program should be reevaluated. (PsycINFO Database Record",2018,No differences in the probabilities of transitions between these drug use patterns were found between the intervention and control groups.,"['6,391 students from 72 public schools in 6 Brazilian cities revealed 3 distinct patterns of drug use behavior: abstainers/low users (81.54% at baseline, 70.61% after 21 months), alcohol users/binge drinkers (16.65% at baseline, 21.45% after 21 months), and polydrug users (1.80% at baseline, 7.92% after 21 months', '2014-2015 with 2 parallel arms (intervention and control']",[],"['probabilities of transitions', 'use of drugs (any alcohol use, binge drinking, tobacco, marijuana, inhalants, and cocaine']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0556297', 'cui_str': 'Current drinker of alcohol (finding)'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",6391.0,0.0597456,No differences in the probabilities of transitions between these drug use patterns were found between the intervention and control groups.,"[{'ForeName': 'Juliana Y', 'Initials': 'JY', 'LastName': 'Valente', 'Affiliation': 'Department of Preventive Medicine.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Swardfager', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Department of Preventive Medicine.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000329']
963,31784348,An Open-label Study With Pirfenidone on Chronic Hypersensitivity Pneumonitis.,"BACKGROUND


Chronic hypersensitivity pneumonitis (cHP) represents a severe lung disease often evolving to fibrosis with the subsequent destruction of the lung parenchyma. There are no approved therapies with confirmed efficacy to deal with this disease.
METHODS


We performed an open-label, proof of concept study, to evaluate the efficacy and safety of pirfenidone added to immunosuppressive drugs on the treatment of cHP. We included 22 patients assigned to two groups: Group 1, nine patients that received prednisone plus azathioprine and Group 2, thirteen patients, received prednisone plus azathioprine and pirfenidone (ClinicalTrials.gov identifier NCT02496182). There were no significant imbalances in clinically relevant baseline characteristics between two study groups.
RESULTS


After 1 year of treatment, inclusion of pirfenidone was not associated with improved forced vital capacity (primary end-point). A not significant tendency to show higher improvement of diffusion capacity of the lung for carbon monoxide (D LCO ) was observed in the group receiving pirfenidone (p=0.06). Likewise, a significant improvement in the total score on the SGRQ was found in the group 2 (p=0.02) without differences in other two questionnaires related to quality of life (ATAQ-IPF and EQ-5D-3L). HRCT showed a decrease of the ground glass attenuation without changes in the fibrotic lesions and without differences between both groups.
CONCLUSIONS


These findings suggest that the addition of pirfenidone to the anti-inflammatory treatment in patients with chronic HP may improve the outcome with acceptable safety profile. However, prospective randomized double-blind, placebo-controlled trials in largest cohorts are needed to validate its efficacy.",2020,"HRCT showed a decrease of the ground glass attenuation without changes in the fibrotic lesions and without differences between both groups.
","['Chronic hypersensitivity pneumonitis (cHP', '22 patients assigned to two groups: Group 1, nine patients that received', 'patients with chronic HP']","['pirfenidone', 'prednisone plus azathioprine', 'placebo', 'Pirfenidone', 'HRCT', 'prednisone plus azathioprine and pirfenidone']","['efficacy and safety', 'quality of life (ATAQ-IPF and EQ-5D-3L', 'diffusion capacity of the lung for carbon monoxide (D LCO ', 'total score on the SGRQ', 'Chronic Hypersensitivity Pneumonitis', 'forced vital capacity']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0002390', 'cui_str': 'Pneumonitis, Hypersensitivity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0002390', 'cui_str': 'Pneumonitis, Hypersensitivity'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}]",22.0,0.082069,"HRCT showed a decrease of the ground glass attenuation without changes in the fibrotic lesions and without differences between both groups.
","[{'ForeName': 'Heidegger', 'Initials': 'H', 'LastName': 'Mateos-Toledo', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Mejía-Ávila', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Rodríguez-Barreto', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'José Guillermo', 'Initials': 'JG', 'LastName': 'Mejía-Hurtado', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rojas-Serrano', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Estrada', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Castillo-Pedroza', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Castillo-Castillo', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gaxiola', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Ivette', 'Initials': 'I', 'LastName': 'Buendía-Roldan', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Selman', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas, Mexico City, Mexico. Electronic address: mselmanl@yahoo.com.mx.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2019.08.019']
964,31770296,"Preemptive Pregabalin in Children and Adolescents Undergoing Posterior Instrumented Spinal Fusion: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial.","BACKGROUND


Pregabalin as part of a multimodal pain-management regimen has been shown to reduce opioid consumption after spinal surgery in adults but it is unclear whether this is also true in adolescents. Pregabalin has been found to have neuroprotective effects and therefore could have a positive impact on pain after spinal deformity surgery. We conducted a randomized, double-blinded, placebo-controlled clinical trial of adolescent patients undergoing spinal fusion to evaluate the short-term effects of pregabalin on postoperative pain and opioid consumption.
METHODS


Adolescents with adolescent idiopathic scoliosis, Scheuermann kyphosis, or spondylolisthesis who were scheduled for posterior spinal fusion with all-pedicle-screw instrumentation were randomized to receive either pregabalin (2 mg/kg twice daily) or placebo preoperatively and for 5 days after surgery. The patients ranged from 10 to 21 years of age. The primary outcome was total opioid consumption as measured with use of patient-controlled analgesia. Postoperative pain scores and opioid-related adverse effects were evaluated.
RESULTS


Sixty-three of 77 eligible patients were included and analyzed. Cumulative oxycodone consumption per kilogram did not differ between the study groups during the first 48 hours postoperatively, with a median of 1.44 mg/kg (95% confidence interval [CI],1.32 to 1.67 mg/kg) in the pregabalin group and 1.50 mg/kg (95% CI, 1.39 to 1.79 mg/kg) in the placebo group (p = 0.433). A subgroup analysis of 51 patients with adolescent idiopathic scoliosis showed the same result, with a mean of 1.45 mg/kg (95% CI, 1.24 to 1.65 mg/kg) in the pregabalin group and 1.59 mg/kg (95% CI, 1.37 to 1.82 mg/kg) in the placebo group (p = 0.289). Total oxycodone consumption per hour (mg/kg/hr) was not different between the groups over the time points (p = 0.752). The postoperative pain scores did not differ significantly between the groups (p = 0.196).
CONCLUSIONS


The use of perioperative pregabalin does not reduce the postoperative opioid consumption or pain scores in adolescents after posterior spinal fusion surgery.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The use of perioperative pregabalin does not reduce the postoperative opioid consumption or pain scores in adolescents after posterior spinal fusion surgery.
","['adolescents after posterior spinal fusion surgery', '51 patients with adolescent idiopathic scoliosis', 'Sixty-three of 77 eligible patients were included and analyzed', 'adolescent patients undergoing spinal fusion', 'Adolescents with adolescent idiopathic scoliosis, Scheuermann kyphosis, or spondylolisthesis who were scheduled for posterior spinal fusion with all-pedicle-screw instrumentation', 'Children and Adolescents Undergoing Posterior']","['pregabalin', 'Placebo', 'Instrumented Spinal Fusion', 'placebo', 'Preemptive Pregabalin', 'perioperative pregabalin', 'Pregabalin']","['opioid consumption', 'Postoperative pain scores and opioid-related adverse effects', 'postoperative pain scores', 'postoperative opioid consumption or pain scores', 'Cumulative oxycodone consumption per kilogram', 'Total oxycodone consumption', 'total opioid consumption as measured with use of patient-controlled analgesia']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0919636', 'cui_str': 'Operative spinal fusion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis (disorder)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037935', 'cui_str': 'Spinal Fusion'}, {'cui': 'C0036310', 'cui_str': 'Scheuermann Kyphosis'}, {'cui': 'C0038016', 'cui_str': 'Spondylisthesis'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0037935', 'cui_str': 'Spinal Fusion'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}]",77.0,0.746358,"The use of perioperative pregabalin does not reduce the postoperative opioid consumption or pain scores in adolescents after posterior spinal fusion surgery.
","[{'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Helenius', 'Affiliation': 'Departments of Anaesthesiology and Intensive Care (L.L.H. and T.M.) and Paediatric Orthopaedic Surgery (L.L.H., H.O., M.L., O.P., and I.J.H.), University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Oksanen', 'Affiliation': 'Departments of Anaesthesiology and Intensive Care (L.L.H. and T.M.) and Paediatric Orthopaedic Surgery (L.L.H., H.O., M.L., O.P., and I.J.H.), University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Lastikka', 'Affiliation': 'Departments of Anaesthesiology and Intensive Care (L.L.H. and T.M.) and Paediatric Orthopaedic Surgery (L.L.H., H.O., M.L., O.P., and I.J.H.), University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Pajulo', 'Affiliation': 'Departments of Anaesthesiology and Intensive Care (L.L.H. and T.M.) and Paediatric Orthopaedic Surgery (L.L.H., H.O., M.L., O.P., and I.J.H.), University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Tuula', 'Initials': 'T', 'LastName': 'Manner', 'Affiliation': 'Departments of Anaesthesiology and Intensive Care (L.L.H. and T.M.) and Paediatric Orthopaedic Surgery (L.L.H., H.O., M.L., O.P., and I.J.H.), University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ilkka J', 'Initials': 'IJ', 'LastName': 'Helenius', 'Affiliation': 'Departments of Anaesthesiology and Intensive Care (L.L.H. and T.M.) and Paediatric Orthopaedic Surgery (L.L.H., H.O., M.L., O.P., and I.J.H.), University of Turku and Turku University Hospital, Turku, Finland.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00650']
965,31733813,"Task-sharing of psychological treatment for antenatal depression in Khayelitsha, South Africa: Effects on antenatal and postnatal outcomes in an individual randomised controlled trial.","The study's objective was to determine the effectiveness of a task-sharing psychological treatment for perinatal depression using non-specialist community health workers. A double-blind individual randomised controlled trial was conducted in two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town. Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS) were randomised into the intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls). The primary outcome was response on the Hamilton Depression Rating Scale (HDRS) at three months postpartum (minimum 40% score reduction from baseline) among participants who did not experience pregnancy or infant loss (modified intention-to-treat population) (registered on Clinical Trials: NCT01977326). Of 2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n = 200; intervention: n = 184). There were no significant differences in response on the HDRS at three months postpartum between the intervention and control arm. A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa. The findings give cause for reflection on the strategy of task-sharing in low-resource settings.",2020,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","['two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town', 'antenatal depression in Khayelitsha, South Africa', 'perinatal depression using non-specialist community health workers', 'Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS', '2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n\u202f=\u202f200; intervention: n\u202f=\u202f184', 'women living in Khayelitsha, South Africa']","['Task-sharing of psychological treatment', 'intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls', 'task-sharing psychological treatment']","['HDRS', 'Hamilton Depression Rating Scale (HDRS']","[{'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0222045'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",2187.0,0.206439,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","[{'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa; King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: crick.lund@uct.ac.za.""}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Garman', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Davies', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Memory', 'Initials': 'M', 'LastName': 'Munodawafa', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Honikman', 'Affiliation': 'Perinatal Mental Health Project, Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Medical Research Council, Durban, South Africa; Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bass', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bolton', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joska', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Kagee', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prince', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa; MRC Unit on Risk & Resilience in Mental Disorders, Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Hanani', 'Initials': 'H', 'LastName': 'Tabana', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa, And School of Nursing and Midwifery, Queens University, Belfast, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK; Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.""}, {'ForeName': 'Atalay', 'Initials': 'A', 'LastName': 'Alem', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Susser', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, USA; New York State Psychiatric Institute, New York, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103466']
966,31195885,"Calorie counting smart phone apps: Effectiveness in nutritional awareness, lifestyle modification and weight management among young Indian adults.","Calorie counting mobile apps claim to assist in weight management by helping users monitor their diets and track activity. This study assessed quality and effectiveness of popular calorie counting apps in weight management and behaviour change. Top 20 apps were selected from Google Play store and their quality was assessed using a 55-point scoring scale on attributes like standards used, content accuracy, user interface and sources of database. The mean (±SD (standard deviation)) quality score was 36.95 (±5.65). The calorie and activity recommendations were compared with standards and over 65 per cent apps over/underestimated calorie intake. To assess effectiveness, 60 young volunteers were recruited and divided into two groups. The intervention group (n = 30) was asked to use one of the top 3 apps for 8 weeks. Pre- and post-comparisons were made with the control group (n = 28). No significant difference was noted in anthropometry or food consumption. There was increasing trend (13.33%) in physical activity in the intervention group.",2020,No significant difference was noted in anthropometry or food consumption.,"['60 young volunteers', 'young Indian adults']",['Calorie counting smart phone apps'],"['quality score', 'mean (±SD (standard deviation', 'weight management and behaviour change', 'physical activity', 'anthropometry or food consumption']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.0273592,No significant difference was noted in anthropometry or food consumption.,"[{'ForeName': 'Paromita', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'National Institute of Nutrition, Indian Council for Medical Research, India.'}, {'ForeName': 'Vishnu Vardhana Rao', 'Initials': 'VVR', 'LastName': 'Mendu', 'Affiliation': 'National Institute of Medical Statistics, Indian Council of Medical Research, India.'}, {'ForeName': 'Damayanthi', 'Initials': 'D', 'LastName': 'Korrapati', 'Affiliation': ''}, {'ForeName': 'SubbaRao M', 'Initials': 'SM', 'LastName': 'Gavaravarapu', 'Affiliation': 'National Institute of Nutrition, Indian Council for Medical Research, India.'}]",Health informatics journal,['10.1177/1460458219852531']
967,31438903,"Pilot study of a two-arm non-randomized controlled cluster trial of a psychosocial intervention to improve late life depression in socioeconomically deprived areas of São Paulo, Brazil (PROACTIVE): feasibility study of a psychosocial intervention for late life depression in São Paulo.","BACKGROUND


Depression is a common and recurrent condition among older adults and is associated with poor quality of life and increased health care utilization and costs. The purpose of this pilot study was to assess the feasibility of delivering a psychosocial intervention targeting depression, and to develop the procedures to conduct a cluster randomized controlled trial among older adults registered with primary care clinics in poor neighbourhoods of São Paulo, Brazil.
METHODS


We conducted a pilot study of a two-arm cluster, non-randomized controlled trial. Two primary care clinics adhering to the Family Health Strategy were allocated to either the intervention or the control arm. In the control arm, patients received enhanced usual care consisting of staff training for improved recognition and management of depression. In the intervention arm, alongside the enhanced usual care, patients received a 17-week psychosocial intervention delivered by health workers assisted with an application installed in a tablet.
RESULTS


We randomly selected 579 of 2020 older adults registered in the intervention clinic to participate in the study. Among these individuals, 353 were assessed for depression and 40 (11.0%) scored at least 10 on the PHQ-9 and were therefore invited to participate. The consent rate was 33/40 (82%) with a resulting yield of 33/579 (5.7%). In the control arm, we randomly selected 320 older adults among 1482 registered in the clinic, 223 were assessed for depression and 28 (12.6%) scored 10 or above on the PHQ-9. The consent rate was 25/28 (89%), with a resulting yield of 25/320 (7.8%). Of the 33 who consented in the intervention arm, 19 (59.4%) completed all sessions. The mean PHQ-9 at follow-up (approximately 30 weeks after inclusion) were 12.3 (SD = 3.7) and 3.8 (SD = 3.9) in the control and intervention arms, respectively. Follow-up rates were 92 and 94% in control and intervention arms, respectively.
CONCLUSIONS


Identification and engagement of clinics, randomization, recruitment of individuals, measures, and baseline and follow-up assessments all proved to be feasible in primary care clinics in São Paulo, Brazil. Results support the development of a definitive cluster randomized controlled trial.
TRIAL REGISTRATION


This study was retrospectively registered with Registro Brasileiro de Ensaios Clínicos (ReBEC), number RBR-5nf6wd . Registered 06 August 2018.",2019,"Follow-up rates were 92 and 94% in control and intervention arms, respectively.
","['late life depression in São Paulo', 'older adults registered with primary care clinics in poor neighbourhoods of São Paulo, Brazil', 'Among these individuals, 353 were assessed for depression and 40 (11.0%) scored at least 10 on the PHQ-9 and were therefore invited to participate', 'Two primary care clinics adhering to the Family Health Strategy', '320 older adults among 1482 registered in the clinic, 223 were assessed for depression and 28 (12.6%) scored 10 or above on the PHQ-9', '2020 older adults registered in the intervention clinic to participate in the study', 'older adults', 'socioeconomically deprived areas of São Paulo, Brazil (PROACTIVE']","['17-week psychosocial intervention delivered by health workers assisted with an application installed in a tablet', 'psychosocial intervention targeting depression', 'enhanced usual care consisting of staff training', 'psychosocial intervention']","['mean PHQ-9', 'late life depression', 'consent rate']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0600220', 'cui_str': 'Family Health'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]",353.0,0.0886691,"Follow-up rates were 92 and 94% in control and intervention arms, respectively.
","[{'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Scazufca', 'Affiliation': 'LIM-23, Faculdade de Medicina, Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Universidade de São Paulo, São Paulo, Brazil. scazufca@gmail.com.'}, {'ForeName': 'Maria Clara P', 'Initials': 'MCP', 'LastName': 'de Paula Couto', 'Affiliation': 'LIM-23, Faculdade de Medicina, Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maiara Garcia', 'Initials': 'MG', 'LastName': 'Henrique', 'Affiliation': 'LIM-23, Faculdade de Medicina, Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana Vilela', 'Initials': 'AV', 'LastName': 'Mendes', 'Affiliation': 'LIM-23, Faculdade de Medicina, Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Departamento de Medicina Preventiva, Faculdade de Medicina (FMUSP), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Paula Carvalho', 'Initials': 'PC', 'LastName': 'Pereda', 'Affiliation': 'Departamento de Economia, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renato M', 'Initials': 'RM', 'LastName': 'Franzin', 'Affiliation': 'Departamento de Engenharia de Sistemas Eletrônicos, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio Carlos', 'Initials': 'AC', 'LastName': 'Seabra', 'Affiliation': 'Departamento de Engenharia de Sistemas Eletrônicos, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van de Ven', 'Affiliation': 'Department of Electronics & Computer Engineering, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Centre of Global Mental Health, Institute of Psychiatry, Psychology, and Neurosciences,King's College, London, UK.""}]",BMC public health,['10.1186/s12889-019-7495-5']
968,31785169,Daylight photodynamic therapy for prevention of new actinic keratosis and keratinocyte carcinomas in organ transplants. A cryotherapy-controlled randomized clinical trial.,"BACKGROUND


Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR.
OBJECTIVES


To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR.
METHODS


A randomized, intra-subject controlled, evaluator-blind, split-face and/or scalp trial, from April 2016 to October 2018. Participants were OTR older than 18 years, 1-year posttransplant, with at least 5 AK on each hemi-face/hemi-scalp. One side received six field treatments with DPDT: two sessions 15 days apart at baseline, two at 3 months and two at 9 months after baseline. Control side received lesion-directed treatment with cryotherapy (double freeze-thaw) at baseline, 3 and 9 months. Total number of lesions (AK and KC) at 21 months, number of new AK and KC at 3, 9, 15 and 21 months and treatment preferences were analysed.
RESULTS


Of 24 men included, 23 were analysed at 3 months; and 21, at 9, 15 and 21 months. Mean (SD) age was 69.8 years (9.2). The total number of lesions at 21 months was 4.7 (4.3) for DPDT and 5.8 (5.0) for control side; P = 0.09. DPDT showed significantly lower means [SD] of new lesions compared to control side at 3 months (4.2 [3.4] vs. 6.8 [4.8]; P < 0.001), 9 months (3.0 [3.3] vs. 4.3 [3.4]; P = 0.04) and 15 months (3.0 [4.6] vs. 4.8 [5.0]; P = 0.02), and non-significant at 21 months (3.7 [3.5] vs. 5.0 [4.5]; P = 0.06). Most participants preferred DPDT.
CONCLUSION


DPDT showed potential effectiveness in preventing new AK and KC in OTR by consecutive treatments of field cancerization. The preference for DPDT could facilitate adherence to the long-term treatment necessary in these patients.",2020,"There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR.
","['new actinic keratosis and keratinocyte carcinomas in organ transplants', 'Organ transplant recipients (OTR', '24 men included', 'Participants were OTR older than 18 years, 1 year post-transplant, with at least 5 AK on each hemi-face/hemi-scalp']","['Control side received lesion-directed treatment with cryotherapy', 'daylight photodynamic therapy (DPDT', 'Daylight photodynamic therapy']","['means [SD] of new lesions', 'Total number of lesions', 'Total number of lesions (AK and KC', 'number of new AK and KC']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte (cell)'}, {'cui': 'C0524930', 'cui_str': 'Organ Grafts'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0577303', 'cui_str': 'Total number of lesions (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0874597,"There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR.
","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bernad', 'Affiliation': 'Department of Dermatology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Aguado', 'Affiliation': 'Department of Dermatology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Núñez-Córdoba', 'Affiliation': 'Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Redondo', 'Affiliation': 'Department of Dermatology, Clínica Universidad de Navarra, Pamplona, Spain.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16125']
969,31654779,Psychotropic medications and proton pump inhibitors and the risk of fractures in the teriparatide versus risedronate VERO clinical trial.,"BACKGROUND


VERO is a fracture endpoint study in women with established osteoporosis that showed reduction in the risks of new vertebral fractures (VFx) and clinical fractures in women randomized to teriparatide compared with risedronate. Patients on psychotropic drugs (hypnotics, benzodiazepines and antidepressants [selective serotonin- and norepinephrine-reuptake inhibitors: SSRIs and SNRIs]) and proton pump inhibitors (PPIs) may be at a higher risk of fractures. We studied the association of exposure to these medications with the risk of fractures in the VERO study cohort, including an assessment of their potential interactions with the assigned clinical trial drugs.
METHODS


A total of 1360 postmenopausal women with at least 2 moderate or 1 severe VFx and bone mineral density T-score ≤-1.50 were randomized to subcutaneous daily teriparatide (20μg) or oral weekly risedronate (35mg) in a double-blind, double-dummy, 2-year trial. In thispost-hoc analysis, multivariable log-binomial and Cox proportional hazards regression models were used to estimate adjusted risk ratios (RR) or hazard ratios (HR) for the exposure to these concomitant medications with the occurrence of incident fractures. We also assessed treatment effect modifications on anti-fracture efficacy driven by the use of these medications.
RESULTS


There were 406 (29.9 %), 347 (25.5 %) and 176 (12.9 %) subjects taking PPIs, benzodiazepines/hypnotics, and SSRIs/SNRIs during the study, respectively. For all fracture endpoints, the greater risk reduction of teriparatide versus risedronate did not significantly differ within the categories of psychotropic drugs and PPIs. Multivariable analysis showed that the risk of pooled new and worsened VFx was higher in PPI users than in non-PPI users (RR: 1.57; p=0.032), regardless of the study treatment. Benzodiazepine/hypnotic drug users showed an increased risk of clinical fractures (HR: 1.71; p=0.026) and non-vertebral fragility fractures (NVFFx, HR: 1.89; p=0.017), regardless of the study treatment. Increases in the risk of clinical fractures (HR: 1.93; p=0.018) and NVFFx (HR: 2.16; p=0.011) were also observed in SSRI/SNRI users, regardless of the study treatment.
CONCLUSION


In postmenopausal women with severe osteoporosis, the superior anti-fracture efficacy of teriparatide compared with risedronate was consistent regardless of psychotropic or PPI drugs use. Patients taking psychotropic drugs and PPIs showed a higher risk for NVFFx and VFx respectively, compared to those not on these medications.",2020,"For all fracture endpoints, the greater risk reduction of teriparatide versus risedronate did not significantly differ within the categories of psychotropic drugs and PPIs.","['women with established osteoporosis', '1360 postmenopausal women with at least 2 moderate or 1 severe VFx and bone mineral density T-score ≤-1.50', 'postmenopausal women with severe osteoporosis']","['Psychotropic Medications and Proton Pump Inhibitors', 'psychotropic drugs (hypnotics, benzodiazepines and antidepressants [selective serotonin- and norepinephrine-reuptake inhibitors: SSRIs and SNRIs]) and proton pump inhibitors (PPIs', 'teriparatide', 'subcutaneous daily teriparatide (20\u2009µg) or oral weekly risedronate', 'risedronate', 'Benzodiazepine']","['risk reduction of teriparatide', 'anti-fracture efficacy', 'risk of clinical fractures', 'risk of pooled new and worsened VFx']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}]","[{'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0033978', 'cui_str': 'Psychoactive Drugs'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1579361', 'cui_str': 'SNRIs'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]",1360.0,0.0900318,"For all fracture endpoints, the greater risk reduction of teriparatide versus risedronate did not significantly differ within the categories of psychotropic drugs and PPIs.","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, Canada. Electronic address: davidkendler@gmail.com.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Marin', 'Affiliation': 'Lilly Research Center Europe, Madrid, Spain. Electronic address: marin_fernando@lilly.com.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Geusens', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address: piet.geusens@scarlet.be.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'López-Romero', 'Affiliation': 'Lilly Research Center Europe, Madrid, Spain. Electronic address: lopez_romero_pedro@lilly.com.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'Regional Hospital of Orleans and University of Orleans, Orleans, France. Electronic address: eric.lespessailles@chr-orleans.fr.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Body', 'Affiliation': 'CHU Brugmann, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: jean-jacques.BODY@chu-brugmann.be.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Minisola', 'Affiliation': 'Sapienza Rome University, Rome, Italy. Electronic address: salvatore.minisola@uniroma1.it.'}]",Bone,['10.1016/j.bone.2019.115113']
970,31116358,Effect of Targeting Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation on Postsurgical Delirium Among Older Patients: A Nested Randomized Clinical Trial.,"Importance


Delirium occurs in up to 52% of patients after cardiac surgery and may result from changes in cerebral perfusion. Using intraoperative cerebral autoregulation monitoring to individualize and optimize cerebral perfusion may be a useful strategy to reduce the incidence of delirium after cardiac surgery.
Objective


To determine whether targeting mean arterial pressure during cardiopulmonary bypass (CPB) using cerebral autoregulation monitoring reduces the incidence of delirium compared with usual care.
Design, Setting, and Participants


This randomized clinical trial nested within a larger trial enrolled patients older than 55 years who underwent nonemergency cardiac surgery at a single US academic medical center between October 11, 2012, and May 10, 2016, and had a high risk for neurologic complications. Patients, physicians, and outcome assessors were masked to the assigned intervention. A total of 2764 patients were screened, and 199 were eligible for analysis in this study.
Intervention


In the intervention group, the patient's lower limit of cerebral autoregulation was identified during surgery before CPB. On CPB, the patient's mean arterial pressure was targeted to be greater than that patient's lower limit of autoregulation. In the control group, mean arterial pressure targets were determined according to institutional practice.
Main Outcomes and Measures


The main outcome was any incidence of delirium on postoperative days 1 through 4, as adjudicated by a consensus expert panel.
Results


Among the 199 participants in this study, mean (SD) age was 70.3 (7.5) years and 150 (75.4%) were male. One hundred sixty-two (81.4%) were white, 26 (13.1%) were black, and 11 (5.5%) were of other race. Of 103 patients randomized to usual care, 94 were analyzed, and of 102 patients randomized to the intervention 105 were analyzed. Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04). The odds of delirium were reduced by 45% in patients randomized to the autoregulation group (odds ratio, 0.55; 95% CI, 0.31-0.97; P = .04).
Conclusions and Relevance


The results of this study suggest that optimizing mean arterial pressure to be greater than the individual patient's lower limit of cerebral autoregulation during CPB may reduce the incidence of delirium after cardiac surgery, but further study is needed.
Trial Registration


ClinicalTrials.gov identifier: NCT00981474.",2019,"Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04).","['199 participants in this study, mean (SD) age was 70.3 (7.5) years and 150 (75.4%) were male', 'Older Patients', 'A total of 2764 patients were screened, and 199 were eligible for analysis in this study', '103 patients randomized to usual care, 94 were analyzed, and of 102 patients randomized to the intervention 105 were analyzed', 'One hundred sixty-two (81.4%) were white, 26 (13.1%) were black, and 11 (5.5%) were of other race', 'larger trial enrolled patients older than 55 years who underwent nonemergency cardiac surgery at a single US academic medical center between October 11, 2012, and May 10, 2016, and had a high risk for neurologic complications']","['Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation', 'cardiopulmonary bypass (CPB) using cerebral autoregulation monitoring']","['odds of delirium', 'cerebral autoregulation', 'cerebral perfusion', 'delirium', 'incidence of delirium', 'mean arterial pressure targets', 'mean arterial pressure']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",2764.0,0.273762,"Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04).","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Neufeld', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Probert', 'Affiliation': 'School of Medicine, New York University, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'LaFlam', 'Affiliation': 'Medical Student, School of Medicine, Tufts University, Medford Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Max', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Hori', 'Affiliation': 'Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Mandal', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Penn State University Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Hogue', 'Affiliation': 'Bluhm Cardiovascular Institute, Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Kenton', 'Initials': 'K', 'LastName': 'Zehr', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Duke', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conte', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Penn State University Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'O Joseph', 'Initials': 'OJ', 'LastName': 'Bienvenu', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gottesman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yamaguchi', 'Affiliation': 'Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kraut', 'Affiliation': 'Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA surgery,['10.1001/jamasurg.2019.1163']
971,31768618,"The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects.","Suprahyoid muscle activation and tongue pressure force play a critical role for swallowing function. In addition, dysphagia limit is one of most important factors indicating swallowing efficiency. The purpose of this study was to compare the effects of 8-week training sessions of three different exercises including chin tuck against resistance (CTAR), Shaker exercises and chin tuck exercise with theraband on suprahyoid muscle activity, anterior tongue pressure and dysphagia limit in healthy subjects. Thirty-six healthy volunteers aged between 18 and 40 years who scored below 3 points from Turkish version of Eating Assessment Tool (T-EAT-10) were included in the study, and all participants were divided into three groups randomly. Maximal suprahyoid muscle activations and dysphagia limit of participants were assessed by superficial electromyography. CTAR and chin tuck exercise with theraband increased the maximum suprahyoid muscle activation (p 1  = 0.004, p 2  = 0.018), whereas Shaker exercise did not increase maximal suprahyoid muscle activation (p = 0.507) after exercise training. CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248). There was no statistically significant difference in dysphagia limits in three groups between before and after exercise training (p > 0.05). As a result, although CTAR seems to be the most effective exercise in most parameters, chin tuck exercise with theraband can also be used as an alternative to CTAR to improve suprahyoid muscle activity and tongue pressure.",2020,"CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248).","['Healthy Subjects', 'healthy subjects', 'Thirty-six healthy volunteers aged between 18 and 40\xa0years who scored below 3 points from Turkish version of Eating Assessment Tool (T-EAT-10']","['Different Exercise Trainings', 'exercises including chin tuck against resistance (CTAR), Shaker exercises and chin tuck exercise with theraband']","['Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit', 'maximal suprahyoid muscle activation', 'Maximal suprahyoid muscle activations and dysphagia limit', 'suprahyoid muscle activity, anterior tongue pressure and dysphagia limit', 'tongue pressure', 'anterior tongue pressure', 'dysphagia limits', 'maximum suprahyoid muscle activation', 'CTAR and chin tuck exercise']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]","[{'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0226945', 'cui_str': 'Structure of body of tongue'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",36.0,0.0123338,"CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248).","[{'ForeName': 'Hasan Erkan', 'Initials': 'HE', 'LastName': 'Kılınç', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Lokman Hekim University, Sogutozu, Ankara, 06510, Turkey. erkankilinc86@hotmail.com.'}, {'ForeName': 'Selen Serel', 'Initials': 'SS', 'LastName': 'Arslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Numan', 'Initials': 'N', 'LastName': 'Demir', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Karaduman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}]",Dysphagia,['10.1007/s00455-019-10079-w']
972,31188026,Pharmacogenetics of Metformin for Medication-Induced Weight Gain in Autism Spectrum Disorder.,"Objectives:  We recently found that metformin attenuated weight gain due to mixed dopamine and serotonin receptor antagonists, commonly termed atypical antipsychotics, in children and adolescents with autism spectrum disorder (ASD). Previous studies have found that genetic variation predicts response to metformin in diabetes. In this study, we aimed to assess whether response to metformin for weight gain in this population is associated with variants in five genes previously implicated in metformin response in diabetes.  Methods:  Youth with ASD who experienced significant weight gain while taking mixed receptor antagonist medications were randomly assigned to metformin or placebo for 16 weeks, followed by open-label metformin treatment for 16 weeks. In the 53 participants with available DNA samples, we used a linear, mixed model analysis to assess response in the first 16 weeks of metformin treatment, whether in the randomized or open-label period, based upon genotypes at polymorphisms in five genes previously associated with metformin response in diabetes:  ATM ,  SLC2A2 ,  MATE1 ,  MATE2 , and  OCT1 .  Results:  In the primary analysis, both  ATM  and  OCT1  showed significant effects of genotype on change in body mass index  z -scores, the primary outcome measure, during the first 16 weeks of treatment with metformin. No other polymorphism showed a significant difference.  Conclusion:  As has been shown for metformin treatment in diabetes, genetic variation may predict response to metformin for weight gain in youth with ASD treated with mixed receptor antagonists. Further work is needed to replicate these findings and evaluate whether they can be used prospectively to improve outcomes.",2019,"In the primary analysis, both  ATM  and  OCT1  showed significant effects of genotype on change in body mass index  z","['children and adolescents with autism spectrum disorder (ASD', '53 participants with available DNA samples', 'Youth with ASD who experienced significant weight gain while taking mixed receptor antagonist medications', 'Autism Spectrum Disorder', 'youth with ASD treated with mixed receptor antagonists']","['Metformin', 'metformin or placebo', 'metformin']","['body mass index  z', 'weight gain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",53.0,0.0763889,"In the primary analysis, both  ATM  and  OCT1  showed significant effects of genotype on change in body mass index  z","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Garfunkel', 'Affiliation': '1Department of Psychiatry, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Evdokia A', 'Initials': 'EA', 'LastName': 'Anagnostou', 'Affiliation': '2Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Aman', 'Affiliation': '4Nisonger Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Handen', 'Affiliation': '5Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Sanders', 'Affiliation': '6Department of Psychiatry, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': '7Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': '7Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': '1Department of Psychiatry, Columbia University Medical Center, New York, New York.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0171']
973,31161344,Continuous glucose monitoring targets in type 1 diabetes pregnancy: every 5% time in range matters.,"With randomised trial data confirming that continuous glucose monitoring (CGM) is associated with improvements in maternal glucose control and neonatal health outcomes, CGM is increasingly used in antenatal care. Across pregnancy, the ambition is to increase the CGM time in range (TIR), while reducing time above range (TAR), time below range (TBR) and glycaemic variability measures. Pregnant women with type 1 diabetes currently spend, on average, 50% (12 h), 55% (13 h) and 60% (14 h) in the target range of 3.5-7.8 mmol/l (63-140 mg/dl) during the first, second and third trimesters, respectively. Hyperglycaemia, as measured by TAR, reduces from 40% (10 h) to 33% (8 h) during the first to third trimester. A TIR of >70% (16 h, 48 min) and a TAR of <25% (6 h) is achieved only in the final weeks of pregnancy. CGM TBR data are particularly sensor dependent, but regardless of the threshold used for individual patients, spending ≥4% of time (1 h) below 3.5 mmol/l or ≥1% of time (15 min) below 3.0 mmol/l is not recommended. While maternal hyperglycaemia is a well-established risk factor for obstetric and neonatal complications, CGM-based risk factors are emerging. A 5% lower TIR and 5% higher TAR during the second and third trimesters is associated with increased risk of large for gestational age infants, neonatal hypoglycaemia and neonatal intensive care unit admissions. For optimal neonatal outcomes, women and clinicians should aim for a TIR of >70% (16 h, 48 min) and a TAR of <25% (6 h), from as early as possible during pregnancy.",2019,"Hyperglycaemia, as measured by TAR, reduces from 40% (10 h) to 33% (8 h) during the first to third trimester.","['Pregnant women with type 1 diabetes', 'type 1 diabetes pregnancy']",['continuous glucose monitoring (CGM'],"['Hyperglycaemia', 'CGM time in range (TIR), while reducing time above range (TAR), time below range (TBR) and glycaemic variability measures']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0260841,"Hyperglycaemia, as measured by TAR, reduces from 40% (10 h) to 33% (8 h) during the first to third trimester.","[{'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Norwich Medical School, University of East Anglia, Floor 2, Bob Champion Research and Education Building, Norwich, NR4 7UQ, UK. helen.murphy@uea.ac.uk.'}]",Diabetologia,['10.1007/s00125-019-4904-3']
974,31168590,Bovine Colostrum in the Treatment of Acute Diarrhea in Children: A Double-Blinded Randomized Controlled Trial.,"OBJECTIVES


To evaluate the effect of bovine colostrum (BC) on the treatment of children with acute diarrhea attending the outpatient clinic.
METHODS


This double-blind randomized controlled trial was conducted on 160 children with diarrhea; 80 cases were randomly treated with BC group and 80 cases randomly received placebo (placebo group). All cases were investigated for bacterial causes of diarrhea (Salmonella spp, Shigella spp, diarrheagenic E. coli (DEC), Campylobacter spp., and Vibrio cholerae) as well as for Rotavirus antigen in stool.
RESULTS


After 48 h, the BC group had a significantly lower frequency of vomiting, diarrhea and Vesikari scoring compared with the placebo group (p = 0.000, p = 0.000, p = 0.000, respectively), whether it was due to Rotavirus or E. coli infection.
CONCLUSIONS


BC is effective in the treatment of acute diarrhea and can be considered as adjuvant therapy in both viral and bacterial diarrhea to prevent diarrhea-related complications.",2020,"After 48 h, the BC group had a significantly lower frequency of vomiting, diarrhea and Vesikari scoring compared with the placebo group (p = 0.000, p = 0.000, p = 0.000, respectively), whether it was due to Rotavirus or E. coli infection.
","['160 children with diarrhea; 80 cases', 'Acute Diarrhea in Children', 'children with acute diarrhea attending the outpatient clinic']","['Bovine Colostrum', 'placebo', 'bovine colostrum (BC', 'BC', 'placebo (placebo']","['frequency of vomiting, diarrhea and Vesikari scoring']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",160.0,0.612383,"After 48 h, the BC group had a significantly lower frequency of vomiting, diarrhea and Vesikari scoring compared with the placebo group (p = 0.000, p = 0.000, p = 0.000, respectively), whether it was due to Rotavirus or E. coli infection.
","[{'ForeName': 'Sana Hosny', 'Initials': 'SH', 'LastName': 'Barakat', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria 21131, Egypt.'}, {'ForeName': 'Marwa Ahmed', 'Initials': 'MA', 'LastName': 'Meheissen', 'Affiliation': 'Department of Medical Microbiology and Immunology, Faculty of Medicine, Alexandria University, Alexandria 21131, Egypt.'}, {'ForeName': 'Omneya Magdy', 'Initials': 'OM', 'LastName': 'Omar', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria 21131, Egypt.'}, {'ForeName': 'Doaa Ali', 'Initials': 'DA', 'LastName': 'Elbana', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria 21131, Egypt.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz029']
975,29597104,Development of a coping intervention to improve traumatic stress and HIV care engagement among South African women with sexual trauma histories.,"This paper describes the development and preliminary trial run of ImpACT (Improving AIDS Care after Trauma), a brief coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We engaged in an iterative process to culturally adapt a cognitive-behavioral intervention for delivery within a South African primary care clinic. This process involved three phases: (a) preliminary intervention development, drawing on content from a prior evidence-based intervention; (b) contextual adaptation of the curriculum through formative data collection using a multi-method qualitative approach; and (c) pre-testing of trauma screening procedures and a subsequent trial run of the intervention. Feedback from key informant interviews and patient in-depth interviews guided the refinement of session content and adaptation of key intervention elements, including culturally relevant visuals, metaphors, and interactive exercises. The trial run curriculum consisted of four individual sessions and two group sessions. Strong session attendance during the trial run supported the feasibility of ImpACT. Participants responded positively to the logistics of the intervention delivery and the majority of session content. Trial run feedback helped to further refine intervention content and delivery towards a pilot randomized clinical trial to assess the feasibility and potential efficacy of this intervention.",2018,"This paper describes the development and preliminary trial run of ImpACT (Improving AIDS Care after Trauma), a brief coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories.",['South African women with sexual trauma histories'],"['coping intervention', 'culturally relevant visuals, metaphors, and interactive exercises', 'brief coping intervention', 'cognitive-behavioral intervention']",['traumatic stress and HIV care engagement'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0302829', 'cui_str': 'Metaphor'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",,0.0345222,"This paper describes the development and preliminary trial run of ImpACT (Improving AIDS Care after Trauma), a brief coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories.","[{'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Sikkema', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, United States; Department of Psychology and Neuroscience, Duke University, Durham, NC, United States; Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa. Electronic address: kathleen.sikkema@duke.edu.'}, {'ForeName': 'Karmel W', 'Initials': 'KW', 'LastName': 'Choi', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, United States; Department of Psychology and Neuroscience, Duke University, Durham, NC, United States.'}, {'ForeName': 'Corne', 'Initials': 'C', 'LastName': 'Robertson', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Knettel', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Nonceba', 'Initials': 'N', 'LastName': 'Ciya', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Knippler', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Watt', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Joska', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2018.02.007']
976,31173651,From being alone to being the only one: Neuroticism is associated with an egocentric shift in an alone context.,"OBJECTIVE


This research presents evidence for an egocentric shift occurring among individuals high in Neuroticism by the mere thought-and actual state-of being alone.
METHOD


Four experiments and one experience sampling study (N = 719). In the experiments, Neuroticism was measured, and participants were randomly primed to adopt either an alone or a ""with others"" social context mind-set. The experiments measured different expressions of egocentrism. Study 1 measured perspective-taking, Study 2a was focused on social value orientation, Study 2b measured money allocation in a dictator game, and Study 3 measured self-reported and behavioral interpersonal trust. Trust was also the focus of Study 4, a 5-day experience sampling study.
RESULTS


In an alone mind-set, high (vs. low) Neuroticism individuals were more likely to adopt an egocentric perspective in evaluating social stimuli (Study 1) and to adopt a selfish approach to money allocation (Studies 2a, 2b). Studies 3 and 4 addressed the source of the shift, showing that in an alone mind-set (Study 3) and in an actual alone state (Study 4), Neuroticism was associated with reduced interpersonal trust.
CONCLUSIONS


For high-Neuroticism individuals, thinking about-and actually being-alone induces a sense that they only have themselves to rely on.",2020,"Neuroticism individuals were more likely to adopt an egocentric perspective in evaluating social stimuli (Study 1) and to adopt a selfish approach to money allocation (Studies 2a, 2b).",['Four experiments and one experience sampling study (N\xa0=\xa0719'],[],[],"[{'cui': 'C4279973', 'cui_str': 'Experience Sampling'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],[],,0.0184949,"Neuroticism individuals were more likely to adopt an egocentric perspective in evaluating social stimuli (Study 1) and to adopt a selfish approach to money allocation (Studies 2a, 2b).","[{'ForeName': 'Liad', 'Initials': 'L', 'LastName': 'Uziel', 'Affiliation': 'Psychology Department, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Seemann', 'Affiliation': 'Department of Psychology, Johannes Gutenberg-University of Mainz, Mainz, Germany.'}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Schmidt-Barad', 'Affiliation': 'Psychology Department, Bar-Ilan University, Ramat-Gan, Israel.'}]",Journal of personality,['10.1111/jopy.12494']
977,31175566,Involving Patients in the Development and Evaluation of an Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care: a Mixed Methods Approach.,"This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.",2020,Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group.,"['Twenty-five patients', 'muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care']","['control group (N\u2009=\u20098) or ETEI', 'educational and training experiential intervention (ETEI', 'diet and nutrition education', 'Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care', 'nurse-led session on MIBC education']","['cancer worries and efficacy beliefs', 'cancer worries', 'healthy lifestyle', 'retention rates', 'knowledge', 'confidence in treatment decisions', 'self-efficacy beliefs', 'improved decisional support', 'improved communication']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",25.0,0.0314422,Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group.,"[{'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Mohamed', 'Affiliation': 'Department of Urology and Oncological Sciences, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10028, USA. nihal.mohamed@mountsinai.org.'}, {'ForeName': 'Tung Ming', 'Initials': 'TM', 'LastName': 'Leung', 'Affiliation': 'Department of Urology and Oncological Sciences, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10028, USA.'}, {'ForeName': 'Qainat N', 'Initials': 'QN', 'LastName': 'Shah', 'Affiliation': 'Albany Medical College, 43 New Scotland Ave., Albany, NY, 12208, USA.'}, {'ForeName': 'Sailaja', 'Initials': 'S', 'LastName': 'Pisipati', 'Affiliation': 'University of Nevada Reno School of Medicine, 1664 N Virginia St., Reno, NV, 89557, USA.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Berry', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Cancer Center, 450 Brookline Ave., Boston, MA, 02215, USA.'}, {'ForeName': 'Emma K T', 'Initials': 'EKT', 'LastName': 'Benn', 'Affiliation': 'Department of Urology and Oncological Sciences, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10028, USA.'}, {'ForeName': 'Cheryl T', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Ohio State University, 915 Olentangy River Rd., Columbus, OH, 43212, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Smith Institute for Urology, 450 Lakeville Road, Lake Success, NY, 11042, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mehrazin', 'Affiliation': 'Department of Urology and Oncological Sciences, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10028, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sfakianos', 'Affiliation': 'Department of Urology and Oncological Sciences, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10028, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01534-1']
978,30680633,A pilot randomized controlled trial of 6-week combined exercise program on fasting insulin and fitness levels in individuals with spinal cord injury.,"PURPOSE


The aim of this randomized controlled trial study was to investigate the effect of combined exercise program on the fasting insulin and fitness levels of people with spinal cord injury (SCI).
METHODS


A total of 19 individuals with SCI participated in a combined exercise program consisting of aerobic and resistance exercises for 60 min per day, 3 days per week for 6 weeks. Peak oxygen consumption, body mass index, percent body fat, waist circumference, shoulder abduction and adduction, shoulder flexion and extension, elbow flexion and extension, fasting insulin levels, and homeostasis model assessment of insulin resistance (HOMA-IR) levels were measured at baseline and after the intervention.
RESULTS


The 6-week exercise program significantly decreased the average fasting insulin (baseline: 7.5 ± 4.7 µU/ml vs. post-intervention: 4.5 ± 2.2 µU/ml, p < 0.05) and HOMA-IR (baseline: 1.5 ± 1.0 vs. post-intervention: 0.9 ± 0.4, p < 0.05) in the exercise group, whereas there was no change in control group (between group difference, mean fasting insulin: - 3.2 µU/ml, p = 0.003; mean HOMA-IR: - 0.66, p = 0.001). In addition, muscle strength of the shoulder flexors, extensors, abductors, adductors, and elbow flexors was significantly improved in the exercise group compared to the controls.
CONCLUSION


A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI. These slides can be retrieved under Electronic Supplementary Material.",2019,A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI.,"['people with spinal cord injury (SCI', '19 individuals with SCI participated in a', 'individuals with spinal cord injury']","['combined exercise program', 'combined exercise program consisting of aerobic and resistance exercises']","['Peak oxygen consumption, body mass index, percent body fat, waist circumference, shoulder abduction and adduction, shoulder flexion and extension, elbow flexion and extension, fasting insulin levels, and homeostasis model assessment of insulin resistance (HOMA-IR) levels', 'fasting insulin and HOMA-IR levels', 'average fasting insulin', 'fasting insulin and fitness levels', 'mean fasting insulin', 'muscle strength of the shoulder flexors, extensors, abductors, adductors, and elbow flexors', 'HOMA-IR']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",19.0,0.0718928,A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI.,"[{'ForeName': 'Dong-Il', 'Initials': 'DI', 'LastName': 'Kim', 'Affiliation': 'Department of Professional Therapy, Graduate School of Professional Therapy, Gachon University, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Can Ozan', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hyuna', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Sport Industry Studies, Exercise Medicine and Rehabilitation Laboratory, Yonsei University, 50 Yonsei-Ro, Seodaemun-Gu, Seoul, 120-749, Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ""Korea Disabled People's Development Institute, Seoul, Korea.""}, {'ForeName': 'Sang-Yong', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Gachon University, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Kyong-Mee', 'Initials': 'KM', 'LastName': 'Chung', 'Affiliation': 'Department of Psychology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Young-Hee', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Yonsei University Wonju College of Medicine, Wonju, Gangwon-do, Korea.'}, {'ForeName': 'Bum-Suk', 'Initials': 'BS', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Hospital, Seoul, Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Sport Industry Studies, Exercise Medicine and Rehabilitation Laboratory, Yonsei University, 50 Yonsei-Ro, Seodaemun-Gu, Seoul, 120-749, Korea. jjeon@yonsei.ac.kr.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05885-7']
979,31160171,Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study.,"BACKGROUND


In the Mammary Oncology Assessment of LEE011's (Ribociclib's) Efficacy and Safety (MONALEESA-2) study, combination treatment with the selective inhibitor of cyclin-dependent kinases 4/6 ribociclib with letrozole significantly improved progression-free survival (PFS) versus letrozole alone in postmenopausal women with hormone receptor-positive HR + /HER2 -  advanced breast cancer (ABC). Herein we present results from the subset of US patients enrolled in MONALEESA-2.
PATIENTS AND METHODS


Postmenopausal women with HR + /HER2 -  ABC without previous treatment for advanced disease were randomized (1:1) to ribociclib 600 mg/d (3 weeks on/1 week off) with letrozole 2.5 mg/d (continuous) or placebo with letrozole. The primary end point was locally assessed PFS.
RESULTS


Overall, 213 US patients were enrolled in MONALEESA-2 (ribociclib, n = 100; placebo, n = 113). Baseline characteristics were similar between treatment groups and consistent with the global population. With a median follow-up of 27 months, 38 (38%) and 29 (26%) patients in the ribociclib and placebo groups, respectively, had continued to receive treatment. Median PFS was 27.6 months with ribociclib and 15.0 months with placebo (hazard ratio, 0.53). The most common all-cause adverse events were neutropenia (ribociclib, 72.0% [n = 72]; placebo, 4.6% [n = 5]), nausea (ribociclib, 69.0% [n = 69]; placebo, 44.0% [n = 48]), and fatigue (ribociclib, 60.0% [n = 60]; placebo, 50.5% [n = 55]). Two patients (ribociclib, 2.0%; placebo, 0%) experienced febrile neutropenia.
CONCLUSION


In the US subset of MONALEESA-2, ribociclib with letrozole showed superior efficacy versus letrozole alone. These findings are consistent with the global population and support first-line use of ribociclib with letrozole in patients with HR + /HER2 -  ABC.",2019,"The most common all-cause adverse events were neutropenia (ribociclib, 72.0% [n = 72]; placebo, 4.6% [n = 5]), nausea (ribociclib, 69.0% [n = 69]; placebo, 44.0% [n = 48]), and fatigue (ribociclib, 60.0% [n = 60]; placebo, 50.5% [n = 55]).","['213 US patients were enrolled in MONALEESA-2 (ribociclib, n\xa0= 100; placebo, n\xa0= 113', 'patients with HR + /HER2 -  ABC', 'US Patients', 'postmenopausal women with hormone receptor-positive HR + /HER2 -  advanced breast cancer (ABC', 'Postmenopausal women with HR + /HER2 -  ABC without previous treatment for advanced disease']","['Ribociclib With Letrozole', 'placebo', 'letrozole 2.5 mg/d (continuous) or placebo with letrozole', 'ribociclib', 'letrozole']","['progression-free survival (PFS', 'locally assessed PFS', 'febrile neutropenia', 'Efficacy and Safety', 'nausea', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1597613', 'cui_str': 'letrozole 2.5 MG [Femara]'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.153584,"The most common all-cause adverse events were neutropenia (ribociclib, 72.0% [n = 72]; placebo, 4.6% [n = 5]), nausea (ribociclib, 69.0% [n = 69]; placebo, 44.0% [n = 48]), and fatigue (ribociclib, 60.0% [n = 60]; placebo, 50.5% [n = 55]).","[{'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN; Tennessee Oncology, Nashville, TN. Electronic address: dyardley@tnonc.com.'}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Hart', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN; Florida Cancer Specialists, Fort Myers, FL.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Favret', 'Affiliation': 'US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Virginia Cancer Specialists, PC, Fairfax, VA.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Blau', 'Affiliation': 'Division of Hematology-Oncology, Northwest Medical Specialties, PLLC, Puyallup, WA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Diab', 'Affiliation': 'US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Rocky Mountain Cancer Centers, LLP, Aurora, CO.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Texas Oncology, PA, Tyler, TX.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sparano', 'Affiliation': 'Department of Oncology, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'J Thad', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richards', 'Affiliation': 'US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Oncology and Hematology Associates of Southwest Virginia, Inc, DBA Blue Ridge Cancer Care, Salem, VA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ward', 'Affiliation': 'US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Oncology Hematology Care, Cincinnati, OH.'}, {'ForeName': 'Bhuvaneswari', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center/Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Virginia Piper Cancer Institute, Allina Health, Minneapolis, MN.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Blackwell', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pluard', 'Affiliation': ""Saint Luke's Cancer Institute, Saint Luke's Health Systems, Kansas City, MO.""}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'Department of Medicine, Perlmutter Cancer Center at NYU Langone Health, New York, NY.'}, {'ForeName': 'Cristina I', 'Initials': 'CI', 'LastName': 'Truica', 'Affiliation': 'Department of Medicine, Pennsylvania State Cancer Institute, Hershey, PA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alemany', 'Affiliation': 'Florida Hospital Cancer Institute, Orlando, FL.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Volas-Redd', 'Affiliation': 'Georgia Cancer Specialists affiliated with Northside Hospital Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Shtivelband', 'Affiliation': 'Ironwood Cancer and Research Center, Chandler, AZ.'}, {'ForeName': 'Das', 'Initials': 'D', 'LastName': 'Purkayastha', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Anand A', 'Initials': 'AA', 'LastName': 'Dalal', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Clinical breast cancer,['10.1016/j.clbc.2019.02.007']
980,31758471,Relevant Weight Reduction and Reversed Metabolic Co-morbidities Can Be Achieved by Duodenojejunal Bypass Liner in Adolescents with Morbid Obesity.,"BACKGROUND


Duodenojejunal bypass liner (DJBL) is an endoscopic, reversible bariatric procedure resulting in weight loss and metabolic co-morbidities improvements in the adults.
OBJECTIVES


To determine safety and effectiveness of 12-month treatment with DJBL in adolescents with severe obesity (BMI > 35 kg/m 2 ) and co-morbidities.
METHODS


Post-pubertal subjects were treated with DJBL in an open-label, prospective clinical trial (NTC0218393). They were examined at 3 monthly intervals during the 12 months of DJBL treatment and 12 months of follow-up.
RESULTS


DJBL was successfully placed in 19/22 adolescents (13 females, mean age (95%CI); 17.3 (16.7-17.9) years, BMI-SDS 3.7 (3.6-3.9)). There were no serious device-related adverse effects. Clinically relevant percent total weight loss (%TWL) (mean (95%CI)) 11.4 (7.4-15.3) % and BMI decrease - 4.9 (- 2.4 to - 7.4) kg/m 2  was observed at DJBL removal (n = 19). At 12 months after device removal, %TWL was 4.1 (- 2.6-10.8) % and BMI decrease - 2.6 (0.2 to - 5.4) kg/m 2  when compared with values at baseline (n = 13). HOMA-IR (- 2.1 (- 3 to - 1.3), WBISI 1.15 (0.23 to 2.07), total cholesterol, LDL-c, and triglycerides levels also improved during DJBL treatment and relapsed similarly to weight at 12-month follow-up. A decrease in iron stores, Zn, and Se levels was determined during DJBL treatment and spontaneously improved at follow-up.
CONCLUSIONS


Twelve months of DJBL treatment was safe and effective in adolescents with morbid obesity. Weight regain following device removal and relapse of metabolic complications should be expected.",2020,There were no serious device-related adverse effects.,"['adolescents with morbid obesity', '19/22 adolescents (13 females, mean age (95%CI', 'adolescents with severe obesity (BMI > 35 kg/m 2 ) and co-morbidities.\nMETHODS\n\n\nPost-pubertal subjects', 'Adolescents with Morbid Obesity']","['Duodenojejunal bypass liner (DJBL', 'Duodenojejunal Bypass Liner', 'DJBL']","['Relevant Weight Reduction and Reversed Metabolic', 'Weight regain', 'iron stores, Zn, and Se levels', 'total cholesterol, LDL-c, and triglycerides levels', 'Co-morbidities', 'mean (95%CI', 'serious device-related adverse effects', 'total weight loss (%TWL', 'HOMA-IR']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1626404', 'cui_str': 'Post-pubertal'}]","[{'cui': 'C0450198', 'cui_str': 'Duodenojejunal (qualifier value)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0273943,There were no serious device-related adverse effects.,"[{'ForeName': 'Matjaž', 'Initials': 'M', 'LastName': 'Homan', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia. matjaz.homan@guest.arnes.si.""}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Kovač', 'Affiliation': ""Unit of Special Laboratory Diagnostics, University Children's Hospital, University Medical Center Ljubljana, Vrazov trg 1, SI-1000, Ljubljana, Slovenia.""}, {'ForeName': 'Rok', 'Initials': 'R', 'LastName': 'Orel', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.'}, {'ForeName': 'Primož', 'Initials': 'P', 'LastName': 'Kotnik', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.'}]",Obesity surgery,['10.1007/s11695-019-04279-4']
981,31155645,Optimization with levosimendan improves outcomes after left ventricular assist device implantation.,"OBJECTIVES


The aim of this study was to examine the haemodynamic effects of preoperative levosimendan infusion in patients who underwent left ventricular assist device implantation and evaluate the prognoses.
METHODS


Between May 2013 and October 2018, 85 adult patients who underwent left ventricular assist device implantation were included; 44 and 41 patients suffered from dilated cardiomyopathy and ischaemic cardiomyopathy, respectively. Patients were divided into 2 groups: group A (58 patients) included those who received levosimendan infusion in addition to other inotropes and group B (27 patients) included those who received inotropic agents other than levosimendan. Levosimendan infusion was started at a dose of 0.1 µg⋅kg-1⋅min-1 for a maximum of 48 h without a bolus. The primary outcome was early right ventricular failure (RVF). The secondary outcomes were in-hospital mortality, need for right ventricular assist device, late RVF and recovery of end-organ functions. The safety end points of levosimendan included hypotension, atrial fibrillation, ventricular tachycardia or fibrillation and resuscitated cardiac arrest.
RESULTS


Patient characteristics were similar in both groups. No significant differences between groups were observed in the rates of early mortality, RVF, need for right ventricular assist device, cardiopulmonary bypass time and intensive care unit stay. Survival rates at 30 days, 1 year and 3 years and freedom from late RVF were similar between the groups. Administration of levosimendan was safe, generally well-tolerated and not interrupted because of side effects.
CONCLUSIONS


Levosimendan therapy was well-tolerated in patients who received permanent left ventricular assist devices. Combined preoperative therapy with inotropes and levosimendan significantly improves end-organ functions.",2020,"No significant differences between groups were observed in the rates of early mortality, RVF, need for right ventricular assist device, cardiopulmonary bypass time and intensive care unit stay.","['patients who received permanent left ventricular assist devices', 'Between May 2013 and October 2018, 85 adult patients who underwent left ventricular assist device implantation were included', '44 and 41 patients suffered from dilated cardiomyopathy and ischaemic cardiomyopathy, respectively', 'patients who underwent left ventricular assist device implantation and evaluate the prognoses']","['Levosimendan therapy', 'inotropic agents other than levosimendan', 'levosimendan', 'preoperative levosimendan infusion', 'levosimendan infusion in addition to other inotropes', 'Levosimendan']","['rates of early mortality, RVF, need for right ventricular assist device, cardiopulmonary bypass time and intensive care unit stay', 'early right ventricular failure (RVF', 'Survival rates', 'end-organ functions', 'haemodynamic effects', 'hospital mortality, need for right ventricular assist device, late RVF and recovery of end-organ functions', 'hypotension, atrial fibrillation, ventricular tachycardia or fibrillation and resuscitated cardiac arrest']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0007193', 'cui_str': 'Cardiomyopathy, Dilated'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0304509', 'cui_str': 'Inotropic product'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2939447', 'cui_str': 'Right ventricular failure (disorder)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0183046', 'cui_str': 'Right ventricular assist device'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0042514', 'cui_str': 'Tachycardia, Ventricular'}, {'cui': 'C0232197', 'cui_str': 'Fibrillation (disorder)'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]",85.0,0.104077,"No significant differences between groups were observed in the rates of early mortality, RVF, need for right ventricular assist device, cardiopulmonary bypass time and intensive care unit stay.","[{'ForeName': 'Sinan Sabit', 'Initials': 'SS', 'LastName': 'Kocabeyoglu', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Kervan', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Dogan Emre', 'Initials': 'DE', 'LastName': 'Sert', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Karahan', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Aygun', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Osman Fehmi', 'Initials': 'OF', 'LastName': 'Beyazal', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Ertekin Utku', 'Initials': 'EU', 'LastName': 'Unal', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Akin', 'Affiliation': 'Department of Cardiology, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Demirkan', 'Affiliation': 'Department of Cardiology, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Pac', 'Affiliation': 'Department of Cardiovascular Surgery, Turkiye Yuksek Ihtisas Hospital, Ankara, Turkey.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz159']
982,30914500,n-3 PUFAs improve erythrocyte fatty acid profile in patients with small AAA: a randomized controlled trial.,"Abdominal aortic aneurysm (AAA) is an important cause of death in older adults, which has no current drug therapy. Inflammation and abnormal redox status are believed to be key pathogenic mechanisms for AAA. In light of evidence correlating inflammation with aberrant fatty acid profiles, this study compared erythrocyte fatty acid content in 43 AAA patients (diameter 3.0-4.5 cm) and 52 healthy controls. In addition, the effect of omega-3 PUFA (n-3 PUFA) supplementation on erythrocyte fatty acid content was examined in a cohort of 30 AAA patients as part of a 12 week randomized placebo-controlled clinical trial. Blood analyses identified associations between AAA and decreased linoleic acid (LA), and AAA and increased Δ6-desaturase activity and biosynthesis of arachidonic acid (AA) from LA. Omega-3 PUFA supplementation (1.5 g DHA + 0.3 g EPA/day) decreased red blood cell distribution width (14.8 ± 0.4% to 13.8 ± 0.2%;  P  = 0.003) and levels of pro-inflammatory n-6 PUFAs (AA, 12.46 ± 0.23% to 10.14 ± 0.3%,  P  < 0.001; adrenic acid, 2.12 ± 0.13% to 1.23 ± 0.09%;  P  < 0.001). In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17;  P  < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01;  P  < 0.01) following supplementation. The findings suggest that n-3 PUFAs improve fatty acid profiles and ameliorate factors associated with inflammation in AAA patients.",2019,"In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17;  P  < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01;  P  < 0.01) following supplementation.","['43 AAA patients (diameter 3.0-4.5 cm) and 52 healthy controls', 'patients with small AAA', 'older adults']","['Abdominal aortic aneurysm (AAA', 'n-3 PUFAs', 'omega-3 PUFA (n-3 PUFA) supplementation', 'placebo']","['linoleic acid (LA), and AAA and increased Δ6-desaturase activity and biosynthesis of arachidonic acid (AA', 'erythrocyte fatty acid profile', 'red blood cell distribution width', 'levels of pro-inflammatory n-6 PUFAs', 'erythrocyte fatty acid content', 'Δ-4 desaturase activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162871', 'cui_str': 'Aortic Aneurysm, Abdominal'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",30.0,0.112601,"In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17;  P  < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01;  P  < 0.01) following supplementation.","[{'ForeName': 'Lara T', 'Initials': 'LT', 'LastName': 'Meital', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Windsor', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Rebecca M L', 'Initials': 'RML', 'LastName': 'Ramirez Jewell', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Technical Services University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Sunshine Vascular, Buderim, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Magee', 'Affiliation': 'Sunshine Coast University Hospital Birtinya, Queensland, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': ""O'Donnell"", 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Jha', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Perissiou', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease College of Medicine and Dentistry, James Cook University and Department of Vascular and Endovascular Surgery, Townsville Hospital, Townsville, Australia; and.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Bailey', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brooks', 'Affiliation': 'Centre for Genetics, Ecology, and Physiology, School of Science and Engineering University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Askew', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Fraser D', 'Initials': 'FD', 'LastName': 'Russell', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia frussell@usc.edu.au.'}]",Journal of lipid research,['10.1194/jlr.P093013']
983,31134608,Modified Mini-laparoscopic Surgery Optimized the Laparoscopic Decortication of Renal Cyst.,"PURPOSE


This study was to introduce the modified mini-laparoscopic surgery for renal cyst and investigate itsadvantages on operative time, cosmetic effect and pain reduction by comparison with laparo-endoscopic single sitesurgery (LESS) and conventional laparoscopic surgery.
METHODS AND PATIENTS


Between May 2015 and October 2018, 140 consecutive patients with benign renal cystunderwent laparoscopic decortication of renal cyst. Of which, 48 cases were in mini-laparoscopic surgery group(M group), 56 cases in LESS group and 36 cases in conventional laparoscopic surgery group (C group). The operativetime, blood loss, visual analog scale (VAS) and Scar Cosmesis Assessment and Rating (SCAR) Scale wasrecorded.
RESULTS


The mean operative time in M group (26.08±7.70 min) and C group (28.56 ± 7.99 min). was significantlyless than that in LESS group (47.32 ±10.53 min) (P < 0.01). Mean blood loss did not differ between the 3 groups(P > 0.05). Mean VAS pain scores in M group were significantly lower than that of LESS group and C group onpostoperative day (POD) 1 and 3 (P < 0.01). The SCAR scale of POD 30 in C group (6.25 ± 1.0) was significantlyhigher than that in M group (0.77 ± 0.59) and LESS group (0.98 ± 0.70). The postoperative course was uneventfulwith no morbidity within 1to 6 months of follow-up.
CONCLUSION


Modified mini-laparoscopic decortication of renal cyst have more comprehensive advantages comparingwith LESS and conventional laparoscopic surgery. It is convenient and offered significant cosmetic benefitand reduced incisional pain.",2019,Mean blood loss did not differ between the 3 groups (P>0.05).,['140 consecutive patients with benign renal cyst underwent laparoscopic decortication of renal cyst'],"['modified mini-laparoscopic surgery', 'LESS', 'LESS and conventional laparoscopic surgery', 'conventional laparoscopic surgery', 'laparo-endoscopic single site surgery (LESS) and conventional laparoscopic surgery', 'Modified mini-laparoscopic decortication of renal cyst', 'Modified Mini-laparoscopic Surgery']","['Mean VAS pain scores', 'incisional pain', 'mean operative time', 'Mean blood loss', 'SCAR scale of POD', 'operative time, cosmetic effect and pain reduction', 'operative time, blood loss, visual analog scale (VAS) and Scar Cosmesis Assessment and Rating (SCAR']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0268800', 'cui_str': 'Simple renal cyst (disorder)'}, {'cui': 'C2678502', 'cui_str': 'Decortication (procedure)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2678502', 'cui_str': 'Decortication (procedure)'}, {'cui': 'C0268800', 'cui_str': 'Simple renal cyst (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",140.0,0.0358773,Mean blood loss did not differ between the 3 groups (P>0.05).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University. chen.wei3@zs-hospital.sh.cn.'}, {'ForeName': 'Zhi-Bing', 'Initials': 'ZB', 'LastName': 'Xu', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Cang', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Guo', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}]",Urology journal,['10.22037/uj.v0i0.5029']
984,31758268,Simplify pulpectomy in primary molars with a single-file reciprocating system: a randomized controlled clinical trial.,"OBJECTIVES


To compare the clinical use of a single-file NiTi reciprocal system (sNiTi) to that of stainless steel hand file (SSH) instrumentation in primary tooth pulpectomy.
MATERIALS AND METHODS


A prospective randomized clinical trial was conducted in 34 healthy children aged 3-7 years. Thirty-seven mandibular primary molars were randomly assigned to two groups: sNiTi and SSH. Instrumentation time, obturation time, quality of obturation, and 6- and 12-month clinical and radiographic outcomes were compared between the two groups.
RESULTS


The median instrumentation time using sNiTi (3.23 min) was significantly shorter than that for SSH (7.38 min). Obturation times were not different. The quality of obturation was significantly different only in the mesial root canals; overfilling was seen more in the sNiTi group, while underfilling occurred more in the SSH group. At 6 and 12 months, both groups showed comparable clinical and radiographic success regardless of the type of instrumentation.
CONCLUSIONS


sNiTi shortens instrumentation time with comparable obturation time, overall quality of obturation, and clinical and radiographic outcomes with SSH.
CLINICAL RELEVANCE


Pulpectomy is indicated to prevent premature loss of primary teeth with irreversible inflamed or infected pulp. However, it is complicated and time-consuming. sNiTi reciprocating system is an alternative to hand filing technique, avoiding multiple steps and simplifying pulpectomy procedures.",2020,"The quality of obturation was significantly different only in the mesial root canals; overfilling was seen more in the sNiTi group, while underfilling occurred more in the SSH group.","['Thirty-seven mandibular primary molars', '34 healthy children aged 3-7\xa0years', 'primary molars with a single-file reciprocating system', 'primary teeth with irreversible inflamed or infected pulp']","['Simplify pulpectomy', 'stainless steel hand file (SSH) instrumentation', 'sNiTi and SSH', 'SSH', 'single-file NiTi reciprocal system (sNiTi']","['obturation time, overall quality of obturation, and clinical and radiographic outcomes', 'Instrumentation time, obturation time, quality of obturation, and 6- and 12-month clinical and radiographic outcomes', 'median instrumentation time using sNiTi', 'quality of obturation']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}]","[{'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0001168', 'cui_str': 'Complete obstruction (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",37.0,0.0591135,"The quality of obturation was significantly different only in the mesial root canals; overfilling was seen more in the sNiTi group, while underfilling occurred more in the SSH group.","[{'ForeName': 'Kaewta', 'Initials': 'K', 'LastName': 'Boonchoo', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pattarawadee', 'Initials': 'P', 'LastName': 'Leelataweewud', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. pattarawadee.lee@mahidol.ac.th.'}, {'ForeName': 'Kallaya', 'Initials': 'K', 'LastName': 'Yanpiset', 'Affiliation': 'Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varangkanar', 'Initials': 'V', 'LastName': 'Jirarattanasopha', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}]",Clinical oral investigations,['10.1007/s00784-019-03130-5']
985,31096123,Effects of sleep extension on cognitive/motor performance and motivation in military tactical athletes.,"OBJECTIVE


Investigate the immediate and residual impacts of sleep extension in tactical athletes.
METHODS


A randomized controlled trial (Sleep extension = EXT vs Control = CON) was conducted on 50 (EXT: 20.12 ± 2.01 years vs CON: 19.76 ± 1.09 years) tactical athletes enrolled in the Reserve Officers' Training Corps (ROTC). Participants wore actigraphs for 15 consecutive nights and completed a cognitive/motor battery after seven habitual sleep nights, after four sleep extension nights, and after the resumption of habitual sleep for four nights. The CON group remained on habitual sleep schedules for the entire study.
RESULTS


During the intervention, the EXT group significantly increased mean sleep time (1.36 ± 0.71 h, p < 0.001). After sleep extension, there were significant between-group differences on the mean score change since baseline in Psychomotor Vigilance Test (PVT) reaction time (p = 0.026), Trail Making Test (TMT) - B time (p = 0.027), standing broad jump (SBJ) distance (p < 0.001), and motivation levels [to perform the cognitive tasks (p = 0.003) and the SBJ (p = 0.009)]; with the EXT group showing a greater enhancement in performance/motivation. After resuming habitual sleep schedules, significant between-group differences on the mean score change since baseline persisted on SBJ distance (p = 0.001) and motivation to perform the SBJ (p = 0.035), with the EXT showing greater enhancement in performance/motivation.
CONCLUSION


Increasing sleep duration in military tactical athletes resulted in immediate performance benefits in psychomotor vigilance, executive functioning, standing broad jump distance, and motivation levels. Benefits on motor performance were evident four days after resumption of habitual sleep schedules. Military tactical athletes aiming to optimize their overall performance should consider the impact of longer sleep durations when feasible.",2019,"After sleep extension, there were significant between-group differences on the mean score change since baseline in Psychomotor Vigilance Test (PVT) reaction time (p = 0.026),","['Military tactical athletes', ""50 (EXT: 20.12\xa0±\xa02.01 years vs CON: 19.76\xa0±\xa01.09 years) tactical athletes enrolled in the Reserve Officers' Training Corps (ROTC"", 'tactical athletes', 'military tactical athletes']","['EXT vs Control\xa0=\xa0CON', 'EXT', 'sleep extension', 'CON']","['standing broad jump (SBJ) distance', 'psychomotor vigilance, executive functioning, standing broad jump distance, and motivation levels', 'habitual sleep schedules', 'mean sleep time', 'performance/motivation', 'motivation levels [to perform the cognitive tasks', 'SBJ distance', 'mean score change since baseline in Psychomotor Vigilance Test (PVT) reaction time', 'Trail Making Test (TMT) - B time', 'motor performance']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517490', 'cui_str': '1.09 (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}]",50.0,0.0421917,"After sleep extension, there were significant between-group differences on the mean score change since baseline in Psychomotor Vigilance Test (PVT) reaction time (p = 0.026),","[{'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Ritland', 'Affiliation': 'Department of Kinesiology, University of Maryland, 4200 Valley Drive, College Park, MD, 20742, USA; Military Performance Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA, 01760, USA. Electronic address: bradley.m.ritland.mil@mail.mil.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Simonelli', 'Affiliation': 'Behavioral Biology Branch, Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA. Electronic address: guido.simonelli.ctr@mail.mil.'}, {'ForeName': 'Rodolphe J', 'Initials': 'RJ', 'LastName': 'Gentili', 'Affiliation': 'Department of Kinesiology, University of Maryland, 4200 Valley Drive, College Park, MD, 20742, USA. Electronic address: rodolphe@umd.edu.'}, {'ForeName': 'J Carson', 'Initials': 'JC', 'LastName': 'Smith', 'Affiliation': 'Department of Kinesiology, University of Maryland, 4200 Valley Drive, College Park, MD, 20742, USA. Electronic address: carson@umd.edu.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Maryland, 4200 Valley Drive, College Park, MD, 20742, USA. Electronic address: xinhe@umd.edu.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Mantua', 'Affiliation': 'Behavioral Biology Branch, Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA. Electronic address: janna.r.mantua.ctr@mail.mil.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Balkin', 'Affiliation': 'Behavioral Biology Branch, Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA. Electronic address: thomas.j.balkin.ctr@mail.mil.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Hatfield', 'Affiliation': 'Department of Kinesiology, University of Maryland, 4200 Valley Drive, College Park, MD, 20742, USA. Electronic address: bhatfiel@umd.edu.'}]",Sleep medicine,['10.1016/j.sleep.2019.03.013']
986,31868130,Effects of dynamic lycra orthosis as an adjunct to rehabilitation after botulinum toxin-A injection of the upper-limb in adults following stroke: A single-blinded randomized controlled pilot study.,"BACKGROUND


Dynamic lycra splints are proposed to modify hypertonicity due to their characteristics - neutral warmth, circumferential pressure, and creating a low-intensity prolonged stretch on hypertonic muscles - to contribute to increased sensory awareness of the involved limb.
OBJECTIVES


The aim of this study was to investigate the effects of dynamic lycra orthosis as an adjunct to botulinum toxin-A injection and rehabilitation of the upper-limb in adults following stroke.
METHODS


Patients who had suffered a stroke more than three months previously were randomized into two groups: lycra sleeve plus rehabilitation (n = 10) and only-rehabilitation group (n = 10). After botulinum toxin injection, both groups underwent an upper-limb rehabilitation program. The intervention group wore a lycra sleeve for eight hours a day, five days a week for three weeks in addition to the rehabilitation program. Fugl Meyer upper-limb motor score, Motricity index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in touch-detection thresholds of the fingers measured via Semmes-Weinstein monofilaments were assessed by blinded investigators at before treatment, post-treatment (at 3 weeks) and three months post-treatment. This trial is registered with Clinicaltrials.gov, number NCT03546959.
RESULTS


There were no differences between groups in terms of Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold at any follow-up time points.
CONCLUSIONS


Using lycra splints as an adjunct to an upper-limb rehabilitation program after stroke did not provide additional benefit in spasticity, upper-limb motor function, light touch threshold of fingers or stroke-specific quality-of-life.",2020,"There were no differences between groups in terms of Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold at any follow-up time points.","['adults following stroke', 'Methods : Patients who had suffered a stroke more than three months previously']","['botulinum toxin-A injection', ' ', 'botulinum toxin injection', 'lycra sleeve plus rehabilitation (n = 10) and only-rehabilitation group', 'botulinum toxin-A injection and rehabilitation', 'Dynamic lycra splints', 'upper-limb rehabilitation program', 'dynamic lycra orthosis', 'lycra sleeve']","['Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold', 'Fugl Meyer upper-limb motor score, Motricity index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in touch-detection thresholds of the fingers measured via Semmes-Weinstein monofilaments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0074939', 'cui_str': 'Spandex'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451322', 'cui_str': 'Motricity index (assessment scale)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0423553', 'cui_str': 'Light touch, function (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0612257,"There were no differences between groups in terms of Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold at any follow-up time points.","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Giray', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Kardelen', 'Initials': 'K', 'LastName': 'Gencer Atalay', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Eren', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Osman Hakan', 'Initials': 'OH', 'LastName': 'Gündüz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Karadag-Saygi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2019.1704371']
987,31161241,"Femoral tunnel position in chronic anterior cruciate ligament rupture reconstruction: randomized controlled trial comparing anatomic, biomechanical and clinical outcomes.","PURPOSE


The aim of this study was to compare the outcomes between anteromedial (AM) and transtibial (TT) femoral tunnel positioning techniques for the reconstruction of chronic anterior cruciate ligament (ACL) rupture.
MATERIALS AND METHODS


It is a randomized prospective study of 106 patients who underwent ACL reconstruction because of a chronic ACL rupture (55 AMT, 51 TT). Minimum follow-up was 2 years. Demographic, clinical and radiological data, including MRI grafts' anatomy and biomechanics intraoperative navigation system evaluation, were analyzed. Also, International Knee Documentation Committee score, Tegner Knee score, Lysholm Knee Score, Short-Form Health Survey and 4-point Likert Scale were evaluated.
RESULTS


The AM technique achieves a more anatomic graft than TT technique in both sagittal and coronal plane (6° approximately). Immediate postoperative biomechanical evaluation of the graft showed both techniques significantly improved translational and rotational laxity (p = 0.000). AMT showed superiority only in controlling internal rotation (p = 0.016). Both techniques reported significant improvement in all evaluated score scales, without differences between techniques. Independently of the femoral tunnel positioning technique, patients with cartilage lesion had worse clinical outcomes.
CONCLUSIONS


Our findings suggest that AMT achieves a more anatomical and biomechanically accurate graft allowing better control over internal rotation laxity; however, this does not lead to better clinical outcomes if we compare with TT in the reconstruction of chronic ACL rupture. Patients with chronic ACL rupture and cartilage lesion had worse clinical outcomes, independently the femoral tunnel positioning technique.",2019,Immediate postoperative biomechanical evaluation of the graft showed both techniques significantly improved translational and rotational laxity (p = 0.000).,"['chronic anterior cruciate ligament (ACL) rupture', 'Patients with chronic ACL rupture and cartilage lesion', '106 patients who underwent ACL reconstruction because of a chronic ACL rupture (55 AMT, 51 TT', 'chronic anterior cruciate ligament rupture reconstruction']","['AMT', 'Femoral tunnel position', 'anteromedial (AM) and transtibial (TT) femoral tunnel positioning techniques']","['International Knee Documentation Committee score, Tegner Knee score, Lysholm Knee Score, Short-Form Health Survey and 4-point Likert Scale', 'translational and rotational laxity']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scale'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}]",106.0,0.0457269,Immediate postoperative biomechanical evaluation of the graft showed both techniques significantly improved translational and rotational laxity (p = 0.000).,"[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Minguell', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'Jorge H', 'Initials': 'JH', 'LastName': 'Nuñez', 'Affiliation': 'Knee and Spine Unit, Department of Traumatology and Orthopedic Surgery, University Hospital of Mutua Terrassa (DNR), Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain. hassan2803med@gmail.com.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Reverte-Vinaixa', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sallent', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gargallo-Margarit', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castellet', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02455-x']
988,31757656,"Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial.","BACKGROUND


Laparoscopy-assisted distal gastrectomy (LADG) is increasingly being used as an alternative to open distal gastrectomy (ODG) for gastric cancer treatment. Retrospective studies have shown equivalent survival with the two procedures, but these studies are limited by selection bias because LADG is more technically difficult than ODG. We aimed to evaluate whether LADG was non-inferior to ODG in terms of long-term survival outcomes.
METHODS


We did an open-label, multicentre, non-inferiority, phase 3 randomised controlled trial at 33 institutions in Japan. Patients aged 20-80 years with histologically confirmed gastric adenocarcinoma (T1N0, T1N1, or T2[MP]N0), clinical stage I, in the middle or lower third of the stomach, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with a body-mass index of less than 30 kg/m 2 , were randomly assigned (1:1) to receive ODG or LADG. Randomisation was done by telephone, fax, or with a web-based system in the Japan Clinical Oncology Group Data Center; a minimisation method with a random component was used to adjust for institution and clinical stage (IA or IB). Only study-accredited surgeons performed ODG and LADG. The primary endpoint was relapse-free survival and was analysed according to the intention-to-treat principle. The non-inferiority margin (LADG vs ODG) was set at a hazard ratio (HR) of 1·54. The trial was registered with the UMIN Clinical Trials Registry, UMIN000003319.
FINDINGS


Between March 15, 2010, and Nov 29, 2013, 921 patients were enrolled and randomly assigned to receive ODG (n=459) or LADG (n=462). 912 (99%) participants had the assigned surgery. 5-year relapse-free survival was 94·0% (95% CI 91·4-95·9) in the ODG group and 95·1% (92·7-96·8) in the LADG group. LADG was non-inferior to ODG for relapse-free survival (HR 0·84 [90% CI 0·56-1·27]), p=0·0075). The most common grade 3 or 4 adverse event was bowel obstruction, occurring in 11 (2%) of 455 patients in the ODG group and five (1%) of 457 patients in the LADG group. There were no treatment-related deaths.
INTERPRETATION


This trial supports the non-inferiority of LADG compared with ODG for clinical stage I gastric cancer relapse-free survival, suggesting that LADG should be considered a standard treatment option when performed by experienced surgeons.
FUNDING


Japan National Cancer Center, Ministry of Health, Labour and Welfare of Japan, Japan Agency for Medical Research and Development.",2020,"LADG was non-inferior to ODG for relapse-free survival (HR 0·84 [90% CI 0·56-1·27]), p=0·0075).","['Patients aged 20-80 years with histologically confirmed gastric adenocarcinoma (T1N0, T1N1, or T2[MP]N0), clinical stage I, in the middle or lower third of the stomach, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with a body-mass index of less than 30 kg/m 2', '912 (99%) participants had the assigned surgery', '33 institutions in Japan', 'Between March 15, 2010, and Nov 29, 2013, 921 patients']","['ODG', 'laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection', 'LADG', 'Laparoscopy-assisted distal gastrectomy (LADG', 'ODG or LADG']","['Survival outcomes', '5-year relapse-free survival', 'relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I (finding)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",921.0,0.318253,"LADG was non-inferior to ODG for relapse-free survival (HR 0·84 [90% CI 0·56-1·27]), p=0·0075).","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Katai', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan. Electronic address: hkatai@ncc.go.jp.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Bando', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Takagane', 'Affiliation': 'Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Teshima', 'Affiliation': 'Department of Surgery, National Hospital Organization, Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Koeda', 'Affiliation': 'Department of Surgery, Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Souya', 'Initials': 'S', 'LastName': 'Nunobe', 'Affiliation': 'Department of Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Division of Upper Gastrointestinal Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30332-2']
989,31131137,Characteristics and contraceptive outcomes of women seeking medical or surgical abortion in reproductive health clinics in Cambodia.,"Background


Since the approval of medical abortion in Cambodia in 2010, the proportion of women reporting an abortion has increased. We describe the characteristics and contraceptive outcomes of women seeking medical abortion compared to surgical abortion at four reproductive health clinics in Cambodia.
Methods


Secondary data analysis using data collected in the MObile Technology for Improved Family Planning (MOTIF) trial, a single blind, randomized trial of a personalized, mobile phone-based intervention designed to support post-abortion family planning in Cambodia. Baseline interviews were conducted after women had received post-abortion family planning counselling at the clinic, and follow-up interviews were conducted at 4 and 12 months. We used multivariable logistic regression to assess associations between abortion type and baseline characteristics, contraceptive uptake, repeat pregnancy and repeat abortion. We conducted an exploratory analysis to compare the timing of initiation of long-acting (LA) contraception between women having medical versus surgical abortion over the four-month post-abortion period.
Results


Of the 500 women who participated in the trial, 41% had a medical abortion. In multivariate analyses, women undergoing medical abortion were more likely to be urban residents, have a higher level of education, be undecided or not intending to use family planning, and be undecided or intending to have another child. There was no association between type of abortion and contraceptive uptake, repeat pregnancy or repeat abortion. Women who had medical abortion initiated LA contraception post abortion later than women who had surgical abortion.
Conclusions


Our results suggest women having a medical abortion in Cambodia have different baseline characteristics and had delayed uptake of contraception compared to women having a surgical abortion. However, we cannot draw conclusions on the direction of associations and causality. Further research is recommended to explore reasons for the observed findings with view to increasing access to abortion and post-abortion contraception.",2019,Our results suggest women having a medical abortion in Cambodia have different baseline characteristics and had delayed uptake of contraception compared to women having a surgical abortion.,"['women having medical versus surgical abortion over the four-month post-abortion period', '500 women who participated in the trial, 41% had a medical abortion', 'women undergoing medical abortion', 'Women who had medical abortion initiated LA contraception post abortion later than women who had surgical abortion', 'women seeking medical or surgical abortion in reproductive health clinics in Cambodia', 'women seeking medical abortion compared to surgical abortion at four reproductive health clinics in Cambodia']",['long-acting (LA) contraception'],"['delayed uptake of contraception', 'type of abortion and contraceptive uptake, repeat pregnancy or repeat abortion', 'abortion type and baseline characteristics, contraceptive uptake, repeat pregnancy and repeat abortion']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3146283', 'cui_str': 'Medical abortion'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",,0.153777,Our results suggest women having a medical abortion in Cambodia have different baseline characteristics and had delayed uptake of contraception compared to women having a surgical abortion.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': '1Graduate School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Scott', 'Affiliation': '2Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': '2Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Tansy', 'Initials': 'T', 'LastName': 'Edwards', 'Affiliation': '3MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}]",Contraception and reproductive medicine,['10.1186/s40834-019-0086-0']
990,31122495,"Safety of the tau-directed monoclonal antibody BIIB092 in progressive supranuclear palsy: a randomised, placebo-controlled, multiple ascending dose phase 1b trial.","BACKGROUND


Progressive supranuclear palsy is a rare neurodegenerative disease associated with dysfunctional tau protein. BIIB092 is a humanised monoclonal antibody that binds to N-terminal tau and is thus being assessed as a potential novel treatment for progressive supranuclear palsy. We aimed to investigate the safety and tolerability of BIIB092 in individuals with progressive supranuclear palsy.
METHODS


This 12-week, double-blind, randomised, placebo-controlled, multiple ascending dose, phase 1b trial was done at 13 outpatient sites in the USA. Participants aged 41-86 years with probable or possible progressive supranuclear palsy with a score of 20 or greater on the Mini-Mental State Examination (MMSE) were enrolled. Three BIIB092 dose escalation cohorts (150 mg, 700 mg, or 2100 mg; eight participants per cohort) were tested sequentially. For each dose cohort, the first two participants were randomly assigned by a computer-generated scheme to receive either BIIB092 or placebo intravenously every 4 weeks for 57 days. After 2 days, the six remaining participants in each cohort were randomly assigned (5:1) to receive BIIB092 or placebo for 57 days. An additional expansion panel of 24 patients was randomly assigned (3:1) to receive 2100 mg or placebo every 4 weeks for 57 days. All participants were followed up to day 85. The primary outcome was safety, which was analysed in the treated population (all enrolled participants who received at least one dose of the study drug). This trial is registered with ClinicalTrials.gov, NCT02460094.
FINDINGS


Between Oct 2, 2015, and Oct 19, 2016, 48 participants were enrolled and randomly assigned to the BIIB092 (n=36) and placebo (n=12) groups. No apparent demographic differences were observed between the two groups at baseline. All 48 participants completed the treatment phase of the study. Adverse events were generally mild to moderate in severity; the most common in the placebo and BIIB092 groups were falls (in two [17%] of 12 patients and in ten [28%] of 36 patients), urinary tract infections (in one [8%] of 12 and in six [17%] of 36), contusions (in one [8%] of 12 and in five [14%] of 36), and headaches (in none and in five [14%] of 36). Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia. None was considered to be related to the study drug, all were resolved, and no deaths were reported.
INTERPRETATION


Repeated administration of the anti-tau monoclonal antibody BIIB092, at doses of up to 2100 mg, appears to be well tolerated in participants with progressive supranuclear palsy. Results of this phase 1b trial have informed the design of the ongoing phase 2 PASSPORT (NCT03068468) study to examine the efficacy and safety of BIIB092.
FUNDING


Bristol-Myers Squibb, Biogen.",2019,"Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia.","['Participants aged 41-86 years with probable or possible progressive supranuclear palsy with a score of 20 or greater on the Mini-Mental State Examination (MMSE) were enrolled', 'Between Oct 2, 2015, and Oct 19, 2016, 48 participants were enrolled and randomly assigned to the BIIB092 (n=36) and', 'progressive supranuclear palsy', 'participants with progressive supranuclear palsy', 'individuals with progressive supranuclear palsy', '24 patients', 'All 48 participants completed the treatment phase of the study']","['BIIB092 or placebo', 'placebo', 'tau-directed monoclonal antibody BIIB092']","['Adverse events', 'safety and tolerability', 'severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia', 'headaches', 'urinary tract infections']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0038868', 'cui_str': 'Steele-Richardson-Olszewski Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",48.0,0.474552,"Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia.","[{'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Qureshi', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ahlijanian', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grundman', 'Affiliation': 'Global R&D Partners, LLC, San Diego, CA, USA; University of California, San Diego, CA, USA.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Golbe', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Litvan', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Honig', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tuite', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nikolaus R', 'Initials': 'NR', 'LastName': 'McFarland', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Suilleabhain"", 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Giridhar S', 'Initials': 'GS', 'LastName': 'Tirucherai', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Bechtold', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Bordelon', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Geldmacher', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Grossman', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': 'Boca Raton Institute for Neurodegenerative Disorders, Boca Raton, FL, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Zesiewicz', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Kumar Kandadi', 'Initials': 'KK', 'LastName': 'Muralidharan', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Graham', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Gorman"", 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Samantha Budd', 'Initials': 'SB', 'LastName': 'Haeberlein', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Tien', 'Initials': 'T', 'LastName': 'Dam', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: tien.dam@biogen.com.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30139-5']
991,31124912,Effects of ospemifene on genitourinary health assessed by prospective vulvar-vestibular photography and vaginal/vulvar health indices.,"OBJECTIVE


To prospectively evaluate the effects of ospemifene on the vulva and vagina in postmenopausal women using vulvar-vestibular photography and direct visual assessments.
METHODS


Postmenopausal women (aged 40-80 years) with moderate to severe vaginal dryness as their most bothersome symptom (MBS) were randomized to daily ospemifene 60 mg or placebo in this 12-week, multicenter, double-blind, phase 3 study. Vulvar-vestibular photographic images were captured at baseline and week 12 and were independently assessed with the Vulvar Imaging Assessment Scale (VIAS). Changes from baseline in Vaginal and Vulvar Health Indices (VHI and VuHI) with ospemifene versus placebo were analyzed at weeks 4, 8, and 12. Correlations between VIAS, VHI, and VuHI, with vaginal dryness severity and the Female Sexual Function Index (FSFI) scores were also assessed.
RESULTS


In all, 631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population. Compared with placebo, ospemifene significantly improved total scores for VIAS (P = 0.0154), VHI (P < 0.0001), and VuHI (P < 0.0001) from baseline to week 12; significant VHI (P < 0.0001) and VuHI (P = 0.002) improvements were observed at week 4. Most VHI and VuHI individual items were significantly better with ospemifene versus placebo at week 12 (P < 0.05). Most correlations between the vulvovaginal assessment total scores versus vaginal dryness severity and FSFI scores were significant (P < 0.05).
CONCLUSION


Improvements observed in vulvovaginal health with ospemifene assessed by prospective vulvar-vestibular photography and other direct visual assessments support its efficacy in addition to the treatment of moderate to severe vaginal dryness due to menopause and the use of photographic and direct visual evaluations in future clinical trials.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 VIDEO SUMMARY: Supplemental Digital Content 1, http://links.lww.com/MENO/A415This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.",2019,"Compared with placebo, ospemifene significantly improved total scores for VIAS","['631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population', 'postmenopausal women using vulvar-vestibular photography and direct visual assessments', 'Postmenopausal women (aged 40-80 years) with moderate to severe vaginal dryness as their most bothersome symptom (MBS']","['ospemifene', 'daily ospemifene 60\u200amg or placebo', 'Supplemental Digital Content 1', 'placebo']","['genitourinary health assessed by prospective vulvar-vestibular photography and vaginal/vulvar health indices', 'vulvovaginal assessment total scores versus vaginal dryness severity and FSFI scores', 'Vaginal and Vulvar Health Indices (VHI and VuHI', 'vulvovaginal health', 'Vulvar-vestibular photographic images', 'VIAS, VHI, and VuHI, with vaginal dryness severity and the Female Sexual Function Index (FSFI) scores', 'total scores for VIAS', 'Vulvar Imaging Assessment Scale (VIAS']","[{'cui': 'C1313616', 'cui_str': 'Ospemifene'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1313616', 'cui_str': 'Ospemifene'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3537521', 'cui_str': 'Ospemifene 60 MG [Osphena]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",631.0,0.0338963,"Compared with placebo, ospemifene significantly improved total scores for VIAS","[{'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Goldstein', 'Affiliation': 'Director, Sexual Medicine, Alvarado Hospital, San Diego, CA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University, School of Medicine, IntimMedicine Specialists, Washington, DC.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida, College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Altomare', 'Affiliation': 'Shionogi Inc, Florham Park, NJ.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Shionogi Inc, Florham Park, NJ.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shionogi Inc, Florham Park, NJ.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Schaffer', 'Affiliation': 'Duchesnay Inc, Quebec, Canada.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Soulban', 'Affiliation': 'Duchesnay Inc, Quebec, Canada.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001350']
992,31748982,Effects of argon plasma treatment on the osteoconductivity of bone grafting materials.,"BACKGROUND


The osteoconductive properties of bone grafting materials represent one area of research for the management of bony defects found in the fields of periodontology and oral surgery. From a physico-chemical aspect, the wettability of the graft has been demonstrated to be one of the most important factors for new bone formation. It is also well-known that argon plasma treatment (PAT) and ultraviolet irradiation (UV) may increase the surface wettability and, consequently, improve the regenerative potential of the bone grafts. Therefore, the aim of the present in vitro study was to evaluate the effect of PAT and UV treatment on the osteoconductive potential of various bone grafts.
MATERIALS AND METHODS


The following four frequently used bone grafts were selected for this study: synthetic hydroxyapatite (Mg-HA), biphasic calcium phosphate (BCP), cancellous and cortical xenogenic bone matrices (CaBM, CoBM). Sixty-six serially numbered disks 10 mm in diameter were used for each graft material and randomly assigned to the following three groups: test 1 (PAT), test 2 (UV), and control (no treatment). Six samples underwent topographic analysis using SEM pre- and post-treatments to evaluate changes in surface topography/characteristics. Additionally, cell adhesion and cell proliferation were evaluated at 2 and 72 h respectively following incubation in a three-dimensional culture system utilizing a bioreactor. Furthermore, the effects of PAT and UV on immune cells were assessed by measuring the viability of human macrophages at 24 h.
RESULTS


The topographic analysis showed different initial morphologies of the commercial biomaterials (e.g., Mg-HA and BCP showed flat morphology; BM samples were extremely porous with high roughness). The surface analysis following experimental treatments did not demonstrate topographical difference when compared with controls. Investigation of cells demonstrated that PAT treatment significantly increased cell adhesion of all 4 evaluated bone substitutes, whereas UV failed to show any statistically significant differences. The viability test revealed no differences in terms of macrophage adhesion on any of the tested surfaces.
CONCLUSION


Within their limitations, the present results suggest that treatment of various bone grafting materials with PAT appears to enhance the osteoconductivity of bone substitutes in the early stage by improving osteoblast adhesion without concomitantly affecting macrophage viability.
CLINICAL RELEVANCE


Treatment of bone grafts with PAT appears to result in faster osseointegration of the bone grafting materials and may thus favorably influence bone regeneration.",2020,"Investigation of cells demonstrated that PAT treatment significantly increased cell adhesion of all 4 evaluated bone substitutes, whereas UV failed to show any statistically significant differences.",[],"['argon plasma treatment (PAT) and ultraviolet irradiation (UV', 'argon plasma treatment', 'PAT and UV treatment', 'PAT', 'synthetic hydroxyapatite (Mg-HA), biphasic calcium phosphate (BCP), cancellous and cortical xenogenic bone matrices (CaBM, CoBM']","['osteoconductivity of bone grafting materials', 'cell adhesion', 'cell adhesion and cell proliferation', 'viability of human macrophages', 'macrophage adhesion']",[],"[{'cui': 'C0003781', 'cui_str': 'Argon'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0210087', 'cui_str': 'biphasic calcium phosphate'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}]",66.0,0.0438062,"Investigation of cells demonstrated that PAT treatment significantly increased cell adhesion of all 4 evaluated bone substitutes, whereas UV failed to show any statistically significant differences.","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Canullo', 'Affiliation': 'Private practice, Via Nizza, 46, 00198, Rome, Italy. luigicanullo@yahoo.com.'}, {'ForeName': 'Tullio', 'Initials': 'T', 'LastName': 'Genova', 'Affiliation': 'CIR Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Rakic', 'Affiliation': 'Department of Periodontology, Nantes University, Nantes, France.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Miron', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Muzzi', 'Affiliation': 'Department of Science, University Roma Tre, Viale G. Marconi, 446, 00146, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Carossa', 'Affiliation': 'CIR Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mussano', 'Affiliation': 'CIR Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}]",Clinical oral investigations,['10.1007/s00784-019-03119-0']
993,30590600,When is it appropriate to stop non-vitamin K antagonist oral anticoagulants before catheter ablation of atrial fibrillation? A multicentre prospective randomized study.,"AIMS


Although a recent expert consensus statement has recommended periprocedural uninterrupted (UI) non-vitamin K antagonist oral anticoagulants (NOACs) during catheter ablation of atrial fibrillation (AF) as a Class I indication, there have been no clear randomized trials. We investigated the safety and efficacy of UI, procedure day single-dose skipped (SDS), and 24-hour skipped (24S) NOACs in patients undergoing AF ablation.
METHODS AND RESULTS


In this prospective, open-label, randomized multicentre trial, 326 patients (75% male, 58 ± 11 years old) scheduled for AF catheter ablation were randomly assigned in a 1:1:1 ratio to UI, SDS, and 24S at three tertiary hospitals. Bridging with low molecular weight heparin was carried out in the patients with persistent AF who were assigned to the 24S group. Dabigatran, rivaroxaban, and apixaban were assigned in order after randomization. The primary endpoint was the incidence of bleeding events within 1 month after ablation. The secondary endpoints included thrombo-embolic and other procedure-related complications. The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139). The incidence of major bleeding up to 1 month after ablation and a post-procedural reduction in the haemoglobin levels did not significantly differ among the treatment groups and different NOACs (P > 0.05). There were no fatal events or thrombo-embolic complications in all the three groups.
CONCLUSION


In patients undergoing AF ablation, UI NOACs and SDS or double dose skipped NOACs had a comparable efficacy and safety, regardless of the type of NOAC.",2019,"The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139).","['patients undergoing AF ablation', '326 patients (75% male, 58\u2009±\u200911 years old) scheduled for AF catheter ablation', 'patients with persistent AF who were assigned to the 24S group']","['vitamin K antagonist oral anticoagulants (NOACs', 'Dabigatran, rivaroxaban, and apixaban', 'UI, procedure day single-dose skipped (SDS), and 24-hour skipped (24S) NOACs']","['safety and efficacy', 'incidence of bleeding events', 'mean activated clotting time', 'haemoglobin levels', 'thrombo-embolic and other procedure-related complications', 'incidence of major bleeding', 'efficacy and safety', 'intra-procedural heparin requirement', 'fatal events or thrombo-embolic complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0560435', 'cui_str': 'Does skip (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",326.0,0.072216,"The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139).","[{'ForeName': 'Hee Tae', 'Initials': 'HT', 'LastName': 'Yu', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jaemin', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Korea University Cardiovascular Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Junbeom', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Sun', 'Initials': 'JS', 'LastName': 'Uhm', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Youn', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Joung', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Moon-Hyoung', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Korea University Cardiovascular Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hui-Nam', 'Initials': 'HN', 'LastName': 'Pak', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}]",European heart journal,['10.1093/eurheartj/ehy870']
994,31144762,"Suplatast tosilate in patients with interstitial cystitis: Efficacy and treatment possibilities, with suggestions for future assessments.","OBJECTIVE


Suplatast tosilate, a Th2 cytokine inhibitor, was predicted to relieve interstitial cystitis symptoms. Four studies with suplatast tosilate in Japanese interstitial cystitis patients have been conducted: a single-arm clinical study, a phase II dose-ranging trial, a phase III trial with placebo, and a second phase PIII trial with placebo. Treatment efficacy was observed in the first two studies; however, in the phase PIII trials, no significant difference in interstitial cystitis symptom score changes was observed between suplatast tosilate and placebo. We summarized these four studies to investigate factors causing the difference in observed efficacy.
METHODS


Placebo effects in the first two studies and differences regarding study design between the four studies were considered to be possible factors. Therefore, placebo effects were investigated by comparing interstitial cystitis symptom score changes, and the study designs were compared to investigate the effects on observed efficacy.
RESULTS


Interstitial cystitis symptom score changes in the phase PII treatment groups increased in a dose-dependent manner and showed an almost linear relationship with interstitial cystitis symptom score changes observed in placebo groups of 2 phase PIII studies. A major difference regarding the phase PIII study design was the use of diagnostic hydrodistention. Diagnostic hydrodistention and its washout period were applied only in the phase PIII trials.
CONCLUSIONS


Comparison of interstitial cystitis symptom score changes suggested that the placebo effect was very small. Use of diagnostic hydrodistention was considered to be a major difference in the population characteristics of the studies and may have resulted in different observed efficacies. Diagnostic hydrodistention, which potentially influences the treatment effect, is probably not essential for trials of suplatast in interstitial cystitis patients.",2019,"RESULTS


Interstitial cystitis symptom score changes in the phase PII treatment groups increased in a dose-dependent manner and showed an almost linear relationship with interstitial cystitis symptom score changes observed in placebo groups of 2 phase PIII studies.","['Japanese interstitial cystitis patients', 'interstitial cystitis patients', 'patients with interstitial cystitis']",['placebo'],"['Treatment efficacy', 'Interstitial cystitis symptom score changes', 'interstitial cystitis symptom score changes']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0600040', 'cui_str': 'Chronic interstitial cystitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0600040', 'cui_str': 'Chronic interstitial cystitis (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0749172,"RESULTS


Interstitial cystitis symptom score changes in the phase PII treatment groups increased in a dose-dependent manner and showed an almost linear relationship with interstitial cystitis symptom score changes observed in placebo groups of 2 phase PIII studies.","[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'International Consultation on Interstitial Cystitis Japan, Kyoto, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Homma', 'Affiliation': 'Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13968']
995,31119515,"Effect of Spiritist ""Passe"" on Preoperative Anxiety of Surgical Patients: A Randomized Controlled Trial, Double-Blind.","The objective of this study was to evaluate the preoperative anxiety of hospitalized patients exposed to Spiritist ""passe,"" laying on of hand with the intention of healing (Sham) and without laying on of hand. Other variables as depression, pain, physiological parameters, muscle tension, and well-being were assessed. Patients in the Spiritist ""passe"" intervention group showed greater reductions in anxiety (p < 0.05) and muscle tension (p < 0.01) and increases in well-being (p < 0.01). More marked reductions in preoperative anxiety and muscle tension and improvement in well-being were observed in patients exposed to Spiritist ""passe"" compared to Sham or standard medical care.Trial registration: ClinicalTrials.gov Identifier NCT03356691.",2020,"Patients in the Spiritist ""passe"" intervention group showed greater reductions in anxiety (p < 0.05) and muscle tension (p < 0.01) and increases in well-being (p < 0.01).","['Surgical Patients', 'hospitalized patients exposed to Spiritist ""passe,"" laying on of hand with the intention of healing (Sham) and without laying on of hand']","['Spiritist ""Passe']","['depression, pain, physiological parameters, muscle tension, and well-being', 'preoperative anxiety and muscle tension and improvement in well-being', 'Preoperative Anxiety', 'muscle tension', 'anxiety']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0969660', 'cui_str': 'Laying-on-of-Hands'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0427195', 'cui_str': 'Muscle tension (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.109669,"Patients in the Spiritist ""passe"" intervention group showed greater reductions in anxiety (p < 0.05) and muscle tension (p < 0.01) and increases in well-being (p < 0.01).","[{'ForeName': 'Élida Mara', 'Initials': 'ÉM', 'LastName': 'Carneiro', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil. elidamc16@gmail.com.'}, {'ForeName': 'Ariana de Melo', 'Initials': 'AM', 'LastName': 'Tosta', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Izabella Barberato Silva', 'Initials': 'IBS', 'LastName': 'Antonelli', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Veridiana Mariano', 'Initials': 'VM', 'LastName': 'Soares', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Livia Figueira Avezum', 'Initials': 'LFA', 'LastName': 'Oliveira', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Rafaela Miranda Carneiro', 'Initials': 'RMC', 'LastName': 'Borges', 'Affiliation': 'University of Uberaba (UNIUBE), 50, Nenê Sabino Avenue, 1801, Uberaba, MG, 38025 050, Brazil.'}, {'ForeName': 'Adriana Paula', 'Initials': 'AP', 'LastName': 'da Silva', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}, {'ForeName': 'Maria de Fátima', 'Initials': 'MF', 'LastName': 'Borges', 'Affiliation': 'Clinics Hospital, Federal University of Triângulo Mineiro (HC-UFTM), 330, Getúlio Guarita Street, Uberaba, MG, Brazil.'}]",Journal of religion and health,['10.1007/s10943-019-00841-7']
996,31504394,Outcomes of transported and in-house patients on extracorporeal life support: a propensity score-matching study.,"OBJECTIVES


Patients on extracorporeal life support (ECLS), like other critically ill patients, are transported to other institutions for various reasons. However, little has been reported concerning the characteristics and clinical outcomes of transported patients compared with those of in-house patients.
METHODS


A total of 281 adult patients received ECLS between January 2014 and August 2016. Patients who underwent cannulation at another institution by our team were excluded. Patients were divided into 2 groups: transported group (N = 46) and in-house group (N = 235). All 46 patients were safely transported without serious adverse events. The mean travel distance was 206±140 km, with a mean travel time of 78 ± 57 min. Following propensity score matching, 44 transported patients were matched to 148 in-house patients.
RESULTS


In the matched population, the mean age was 48 ± 13 years in the transported group and 49 ± 17 years in the in-house group (P = 0.70). The ECLS type (venoarterial/venovenous) comprised 35/9 (79.5/20.5%) in the transported group and 119/29 (80.4/19.6%) in the in-house group (P = 0.93). Seventeen (38.6%) extracorporeal cardiopulmonary resuscitations were performed in the transported group and 59 (39.9%) were performed in the in-house group (P = 0.91). The incidence of limb ischaemia and acute kidney injury was higher in the transported group (P = 0.007 and P = 0.001, respectively). However, the rate of survival to discharge did not differ between the groups (63.6% in the transported group vs 64.2% in the in-house group, P = 0.94) and there was no difference in overall mortality (P = 0.99).
CONCLUSIONS


Although transported patients had more complications than in-house ECLS patients, clinical outcomes were comparable in the matched population. Transporting ECLS patients to an experienced centre may be justified based on our experience.",2020,"The incidence of limb ischaemia and acute kidney injury was higher in the transported group (P = 0.007 and P = 0.001, respectively).","['Patients who underwent cannulation at another institution by our team were excluded', '44 transported patients were matched to 148 in-house patients', 'matched population, the mean age was 48\u2009±\u200913\u2009years in the transported group and 49\u2009±\u200917\u2009years in the in-house group (P\u2009=\u20090.70', '281 adult patients received ECLS between January 2014 and August 2016']",['extracorporeal life support (ECLS'],"['mean travel distance', 'incidence of limb ischaemia and acute kidney injury', 'rate of survival to discharge', 'overall mortality', 'extracorporeal cardiopulmonary resuscitations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]",281.0,0.0389563,"The incidence of limb ischaemia and acute kidney injury was higher in the transported group (P = 0.007 and P = 0.001, respectively).","[{'ForeName': 'Heemoon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kiick', 'Initials': 'K', 'LastName': 'Sung', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gee Young', 'Initials': 'GY', 'LastName': 'Suh', 'Affiliation': 'Department of Critical Care Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Chi Ryang', 'Initials': 'CR', 'LastName': 'Chung', 'Affiliation': 'Department of Critical Care Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Hoon', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyeongman', 'Initials': 'K', 'LastName': 'Jeon', 'Affiliation': 'Department of Critical Care Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Keumhee Chough', 'Initials': 'KC', 'LastName': 'Carriere', 'Affiliation': 'Department of Mathematical and Statistical Sciences, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Joong Hyun', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yang Hyun', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz227']
997,31741252,Vibrator-Assisted Start-Stop Exercises Improve Premature Ejaculation Symptoms: A Randomized Controlled Trial.,"Premature ejaculation (PE) is associated with decreased quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties. Here we investigated the effectiveness of vibrator-assisted start-stop exercises for treatment of PE, and whether the treatment effect could be enhanced by an additional psychobehavioral intervention. Fifty participants with a mean age of 41.7 years were included and randomized into two treatment groups and a waiting list control group. Participants were instructed to perform start-stop exercises while stimulating the penis with a purpose-made vibrator, 3 times a week for 6 weeks. Additionally, participants in one of the treatment groups received additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week. Data were gathered through online questionnaires before and after treatment, as well as 3 and 6 months after treatment. The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group). The additional psychobehavioral intervention did not further reduce PE symptoms, but did decrease PE-associated negative symptoms such as levels of sexual distress, anxiety, and depression. No side effects were reported. Vibrator-assisted start-stop exercises can be offered as an adequate treatment option for PE.",2020,"The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group).",['Fifty participants with a mean age of 41.7\xa0years'],"['Vibrator-Assisted Start-Stop Exercises', 'waiting list control group', 'additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week', 'vibrator-assisted start-stop exercises', 'Vibrator-assisted start-stop exercises']","['Premature Ejaculation Symptoms', 'Premature ejaculation (PE', 'sexual distress, anxiety, and depression', 'PE symptoms', 'quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184304', 'cui_str': 'Vibrator, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441633'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",50.0,0.0493297,"The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ventus', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Fabriksgatan 2, 20500, Turku, Finland. dventus@abo.fi.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Gunst', 'Affiliation': 'Department of Psychology, University of Turku, Turku, Finland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Katarina G', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Zamore-Söderström', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Kärnä', 'Affiliation': ', Turku, Finland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jern', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Fabriksgatan 2, 20500, Turku, Finland.'}]",Archives of sexual behavior,['10.1007/s10508-019-01520-0']
998,31145203,Cognitive behavior therapy for menopausal symptoms (CBT-Meno): a randomized controlled trial.,"OBJECTIVE


To evaluate the effectiveness of cognitive behavioral therapy for menopausal symptoms (CBT-Meno) compared with a waitlist condition (no active intervention). A randomized controlled trial was conducted with 71 perimenopausal or postmenopausal women who were seeking treatment for menopausal symptoms.
METHODS


Blind assessments were conducted at baseline, 12 weeks postbaseline, and 3 months post-treatment. An intention-to-treat analysis was conducted. CBT-Meno sessions included psychoeducation, and cognitive and behavioral strategies for vasomotor and depressive symptoms, anxiety, sleep difficulties, and sexual concerns. Primary outcomes were scores on the Hot Flash Related Daily Interference Scale (HFRDIS) and Beck Depression Inventory (BDI-II). Secondary outcomes were scores assessing vasomotor and sexual concerns on the Greene Climacteric Scale (GCS-vm, GCS-sex), the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Pittsburgh Sleep Quality Index (PSQI), and the Female Sexual Function Index (FSFI).
RESULTS


There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS; P < 0.001, ηP = 0.21) and ""bothersomeness"" (GCS-vm; P = 0.04, ηP = 0.06), depressive symptoms (BDI-II; P = 0.001, ηP = 0.15), sleep difficulties (PSQI; P = 0.001, ηP = 0.17), and sexual concerns (GCS-sex; P = 0.03, ηP = 0.07). These results were found even when controlling for menopausal staging and medication use. Gains were maintained at 3 months post-treatment.
CONCLUSIONS


CBT-Meno was particularly effective in improving self-reported vasomotor symptoms, depressive symptoms, sleep difficulties, and sexual concerns. Although future studies will be needed to confirm the impact of CBT-Meno on anxiety symptoms, these results suggest that this protocol is effective in targeting commonly reported menopausal symptoms. : Video Summary: Supplemental Digiatl Content 1, http://links.lww.com/MENO/A416.",2019,There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS;,"['menopausal symptoms (CBT-Meno', '71 perimenopausal or postmenopausal women who were seeking treatment for menopausal symptoms']","['Cognitive behavior therapy', ' Video Summary: Supplemental Digiatl Content 1, http://links.lww.com/MENO/A416', 'cognitive behavioral therapy']","['bothersomeness', 'scores on the Hot Flash Related Daily Interference Scale (HFRDIS) and Beck Depression Inventory (BDI-II', 'vasomotor symptom interference (HFRDIS', 'depressive symptoms', 'sexual concerns', 'vasomotor symptoms, depressive symptoms, sleep difficulties, and sexual concerns', 'scores assessing vasomotor and sexual concerns on the Greene Climacteric Scale (GCS-vm, GCS-sex), the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Pittsburgh Sleep Quality Index (PSQI), and the Female Sexual Function Index (FSFI', 'vasomotor and depressive symptoms, anxiety, sleep difficulties, and sexual concerns', 'sleep difficulties']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0682126,There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS;,"[{'ForeName': 'Sheryl M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Donegan', 'Affiliation': ""Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton, Ontario, Canada.""}, {'ForeName': 'Benicio N', 'Initials': 'BN', 'LastName': 'Frey', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Fedorkow', 'Affiliation': 'Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Key', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Randi E', 'Initials': 'RE', 'LastName': 'McCabe', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001363']
999,31724212,Development and validation of a model for hepatitis B e antigen seroconversion in entecavir-treated patients with chronic hepatitis B.,"Achieving hepatitis B e antigen (HBeAg) seroconversion is a satisfactory endpoint during antiviral treatment for chronic hepatitis B (CHB). This study aimed to develop and validate a novel scoring system to predict HBeAg seroconversion during entecavir (ETV) treatment. A total of 526 patients with HBeAg-positive CHB treated with ETV for at least 1 year were randomly assigned to the training and validation cohorts. Baseline parameters including hepatitis B virus DNA, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and alanine aminotransferase level were quantified. Patients who achieved HBeAg seroconversion were compared with those without HBeAg seroconversion. A prediction model was established to predict HBeAg seroconversion during ETV treatment. After a median follow up of 2.67 years, 93 (36.0%) and 87 (32.5%) patients in the training and validation cohorts developed HBeAg seroconversion. A prediction score composed of age, HBsAg and HBcAb quantification was derived. Areas under receiver operating characteristic curve at 5 years of this prediction score were 0.70 and 0.72 in the training and validation cohorts. By using the dual cutoff values of 0.28 and 0.58, the model was endowed with high sensitivity and specificity to exclude or identify patients developing HBeAg seroconversion (90.3% sensitivity and 90.2% specificity in the training cohort as well as 92.8% sensitivity and 84.4% specificity in the validation cohort, respectively). A novel prediction score that uses baseline clinical variables was developed and validated. The score accurately estimates the probabilities of developing HBeAg seroconversion at 5-years ETV therapy in patients with CHB.",2020,The score accurately estimates the probabilities of developing HBeAg seroconversion at 5 years entecavir therapy in CHB patients.,"['chronic hepatitis B (CHB', 'entecavir-treated chronic hepatitis B patients', '526 HBeAg positive CHB patients treated with ETV for at least 1 year']",['entecavir (ETV'],"['HBV DNA, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and alanine aminotransferase (ALT) level', 'HBeAg seroconversion']","[{'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0201480', 'cui_str': 'Hepatitis B core antibody measurement (procedure)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",,0.0486043,The score accurately estimates the probabilities of developing HBeAg seroconversion at 5 years entecavir therapy in CHB patients.,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Grace L-H', 'Initials': 'GL', 'LastName': 'Wong', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Kuang', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Margo J H', 'Initials': 'MJH', 'LastName': 'van Campenhout', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Vincent W-S', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Terry C-F', 'Initials': 'TC', 'LastName': 'Yip', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Chi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Xieer', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weiyin', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yaobo', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaoju', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Boonstra', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Henry L-Y', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.'}]",Journal of medical virology,['10.1002/jmv.25628']
1000,31139827,The Effects of Preventive Home Visits on Older People's Use of Health Care and Social Services and Related Costs.,"BACKGROUND


We use data from a randomized controlled trial on preventive home visits exploring effectiveness on health-related quality of life. In this article, we examine the intervention's cost-effectiveness and effects on quality-adjusted life years in older home-dwelling adults.
METHODS


There were 422 independently home-dwelling participants in the randomized, controlled trial, all aged more than 75 years, with equal numbers in the control and intervention groups. The intervention took place in a municipality in Finland and consisted of multiprofessional preventive home visits. We gathered the data on health care and social services use from central registers and medical records during 1 year before the intervention and 2 years after the intervention. We analyzed the total health care and social services use and costs per person-years and the difference in change in health-related quality of life as measured using the 15D measure. We calculated quality-adjusted life years and incremental cost-effectiveness ratios.
RESULTS


There was no significant difference in baseline use of services or in the total use and costs of health care and social services during the 2-year follow-up between the two groups. In the intervention group, health-related quality of life declined significantly more slowly compared with the control group (-0.015), but there was no significant difference in quality-adjusted life years gained between the groups. The cost-effectiveness plane showed 60% of incremental cost-effectiveness ratios lying in the dominant quadrant, representing additional effects with lower costs.
CONCLUSIONS


This multiprofessional preventive home visit intervention appears to have positive effects on health-related quality of life without accruing additional costs.
THE CLINICAL TRIAL REGISTRATION NUMBER


ACTRN12616001411437.",2020,There was no significant difference in baseline use of services or in the total use and costs of health-care and social services during the two-year follow-up between the two groups.,"['older home-dwelling adults', '422 independently home-dwelling participants in the randomized, controlled trial, all aged over 75 years, with equal numbers in the control and intervention groups']",['Preventive Home Visits'],"['total use and costs of health-care and social services', 'health-related quality of life (HRQoL', 'quality-adjusted life years (QALYs', 'cost-effectiveness plane', 'total health-care and social services use and costs per person years', 'calculated QALYs and incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",422.0,0.0530138,There was no significant difference in baseline use of services or in the total use and costs of health-care and social services during the two-year follow-up between the two groups.,"[{'ForeName': 'Heini A', 'Initials': 'HA', 'LastName': 'Liimatta', 'Affiliation': 'Hyvinkää City Health Center, University of Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Lampela', 'Affiliation': 'Hyvinkää City Health Center, University of Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Laitinen-Parkkonen', 'Affiliation': 'Keski-Uusimaa Joint Municipality Authority for Health Care and Social Services, Uusimaa, Finland.'}, {'ForeName': 'Kaisu H', 'Initials': 'KH', 'LastName': 'Pitkala', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Uusimaa, Finland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz139']
1001,31743822,"Grinding, polishing and glazing of the occlusal surface do not affect the load-bearing capacity under fatigue and survival rates of bonded monolithic fully-stabilized zirconia simplified restorations.","This study aims to evaluate the effect of distinct surface treatments (grinding, polishing and glaze) of the occlusal surface of fully-stabilized zirconia (FSZ) simplified restorations bonded onto epoxy resin on the fatigue behavior of the restorations. Disc shaped specimens of FSZ (IPS e.max Zircad MT Multi) were produced (Ø = 10 mm and 0.8 mm in thickness) and randomly allocated into 5 groups, considering the factor 'surface treatment' of the occlusal surface: Ctrl - as-sintered; Gr - ground with coarse diamond bur; Gr + Pol- grinding + polishing with two-step polishing system; Gr + Gl - grinding + glaze application; Gr + Pol + Gl - grinding + polishing + glaze application. Next, the FSZ intaglio surface was air-abraded with 45 μm aluminum oxide powder for 10 s at 15 mm of distance under 2 bar pressure and the discs were adhesively cemented (Multilink Automix) onto its dentin analogue pair (Ø = 10 mm; thickness = 2.7 mm). Finally, the step-stress fatigue test was executed (load ranging from 200 to 1300 N; step-size of 100N; 10,000 cycles per step, 20 Hz). In addition, surface topography, roughness, phase transformation and fractography analyses were performed. Grinding altered the topographical pattern introducing defects into the material surface and increasing roughness. Polishing and glaze application led to a smoothening effect, reducing surface defects and statistically decreasing roughness. However, the effect on roughness of polishing and glaze was statistically similar. No phase transformation was observed, thus only cubic and tetragonal phases were detected. No surface treatment had a deleterious effect regarding the fatigue failure load, number of cycles for failure and survival rates. All failures (cracks) started on the bonding surface. Thus, polishing and glaze are indicated to reduce surface roughness, despite not leading to differences in terms of fatigue performance.",2020,"No surface treatment had a deleterious effect regarding the fatigue failure load, number of cycles for failure and survival rates.",[],"['distinct surface treatments (grinding, polishing and glaze', ""factor 'surface treatment' of the occlusal surface: Ctrl - as-sintered; Gr - ground with coarse diamond bur; Gr\xa0+\xa0Pol- grinding\xa0+\xa0polishing with two-step polishing system; Gr\xa0+\xa0Gl - grinding\xa0+\xa0glaze application; Gr\xa0+\xa0Pol\xa0+\xa0Gl - grinding\xa0+\xa0polishing\xa0+\xa0glaze application"", 'FSZ']","['roughness of polishing and glaze', 'fatigue failure load, number of cycles for failure and survival rates']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205194', 'cui_str': 'Coarse (qualifier value)'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur (physical object)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding (procedure)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0540078,"No surface treatment had a deleterious effect regarding the fatigue failure load, number of cycles for failure and survival rates.","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.103528']
1002,31740072,"Long-term Oncological Outcomes from an Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).","BACKGROUND


The long-term oncological outcomes of laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC) are still maturing compared with open radical cystectomy (ORC).
OBJECTIVE


To evaluate the 5-yr oncological outcomes of patients recruited into the randomised trial of Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion.
DESIGN, SETTING, AND PARTICIPANTS


A review of prospectively maintained database of 60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC) who were previously randomised in the CORAL trial to receive ORC, RARC, or LRC. This trial was designed to compare the perioperative and early oncological outcomes of these techniques.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcomes of interest included 5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). Kaplan-Meier curves were used to plot the recurrence and survival data. The curves between RFS, CSS, and OS were compared using the log-rank test. A two-sided p value <0.05 was considered significant. Results were analysed on the basis of intention to treat.
RESULTS AND LIMITATIONS


A total of 60 patients with either MIBC (n=38) or HRNMIBC (n=21) were randomised in the CORAL trial to receive ORC, RARC, or LRC. The 5-yr RFS was 60%, 58%, and 71%; 5-yr CSS was 64%, 68%, and 69%; and 5-yr OS was 55%, 65%, and 61% for ORC, RARC, and LRC, respectively. There was no significant difference in RFS, CSS, and OS between the three surgical arms. The principal limitation is the small sample size.
CONCLUSIONS


There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer. Minimally invasive techniques achieved equivalent oncological outcomes to the gold standard of ORC. However, the study was based at a single institution with a small sample size.
PATIENT SUMMARY


Patients who agreed to participate in the randomised trial of either open, laparoscopic, or robotic-assisted radical cystectomy for bladder cancer did not have different cancer outcomes at 5yr.",2020,"There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer.","['60 patients with either MIBC (n=38) or HRNMIBC (n=21', '60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC']","['Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion', 'ORC, RARC, or LRC', 'Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL', 'open, laparoscopic, or robotic-assisted radical cystectomy', 'open radical cystectomy (ORC', 'laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC']","['5-yr CSS', 'curves between RFS, CSS, and OS', 'RFS, CSS, and OS', 'equivalent oncological outcomes', '5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS', '5-yr RFS, CSS, and OS rates', '5-yr OS', '5-yr RFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0042020', 'cui_str': 'Urinary Diversion'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0324034', 'cui_str': 'Coral'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.280624,"There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer.","[{'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, King's College London, London, UK. Electronic address: shamim.khan@gstt.nhs.uk.""}, {'ForeName': 'Kawa', 'Initials': 'K', 'LastName': 'Omar', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK; Department of Urology, King's College Hospital, Denmark Hill, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gan', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""King's College London, School of Cancer and Pharmaceutical Studies, Translational Oncology & Urology Research (TOUR), London, UK.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Thurairaja', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rimington', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, King's College London, London, UK.""}]",European urology,['10.1016/j.eururo.2019.10.027']
1003,31120118,Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial.,"AIMS


To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban.
METHODS AND RESULTS


We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%).
CONCLUSION


Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.",2020,The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment.,"['From May 2014 through June 2018, consecutive patients were enrolled in seven countries', 'patients with acute low-risk PE (EudraCT Identifier 2013-001657-28', 'patients with acute low-risk PE', 'patients with low-risk pulmonary embolism with the']","['oral factor Xa inhibitor rivaroxaban', 'rivaroxaban', 'Rivaroxaban']","['Major bleeding', 'absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities', 'suffered symptomatic non-fatal VTE recurrence', 'symptomatic recurrent venous thromboembolism (VTE) or PE-related death', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4553708', 'cui_str': 'Factor Xa inhibitor'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0242707', 'cui_str': 'Right Ventricular Dysfunction'}, {'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.198423,The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment.,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmidtmann', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center Mainz, Obere Zahlbacher Strasse 69, 55131 Mainz, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, Research Center on Thromboembolic Diseases and Antithrombotic Therapies, University of Insubria, Viale Luigi Borri 57, 21100 Varese, Italy.'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Vascular Medicine, Klinikum Darmstadt, Grafenstrasse 9, 64283 Darmstadt, Germany.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': 'Internal and Cardiovascular Medicine - Stroke Unit, University of Perugia, Via G. Dottori 1, 06129 Perugia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Bernardi', 'Affiliation': 'Department of Emergency Medicine, ULSS n.7, Via Brigata Bisagno 4, 31015 Conegliano (Treviso), Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Thrombosis Research Unit, Division of Hematology, Department of Medicine I, University Hospital ""Carl Gustav Carus"", Fetscherstrasse 74, 01307 Dresden, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bonacchini', 'Affiliation': ""S.C. Medicina d'Urgenza e Pronto Soccorso, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore 3, 20162 Milano, Italy.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'II Medical Department, Coburg Hospital, Ketschendorfer Strasse 33, 96450 Coburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christ', 'Affiliation': 'Emergency Care (Notfallzentrum), Luzerner Kantonsspital, 6000 Luzern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Czihal', 'Affiliation': 'Division of Vascular Medicine, Hospital of the Ludwig-Maximilians-University, Georgenstrasse 5, 80799 Munich, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duerschmied', 'Affiliation': 'Department of Cardiology and Angiology I, Heart Center, Faculty of Medicine, University of Freiburg, Hugstetter Strasse 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Empen', 'Affiliation': 'Department of Internal Medicine, University Medical Center, Fleischmannstrasse 6, 17489 Greifswald, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Espinola-Klein', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ficker', 'Affiliation': 'Department of Respiratory Medicine, Nuremberg General Hospital/Paracelsus Medical University, Prof.-Ernst-Nathan-Strasse 1, 90419 Nuremberg, Germany.'}, {'ForeName': 'Cândida', 'Initials': 'C', 'LastName': 'Fonseca', 'Affiliation': 'Department of Internal Medicine, Hospital S. Francisco Xavier/CHLO, NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Campo Mártires da Pátria 130, 1169-056 Lisbon, Portugal.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Genth-Zotz', 'Affiliation': 'Department of Internal Medicine I, Katholisches Klinikum Mainz, An der Goldrube 11, 55131 Mainz, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jiménez', 'Affiliation': 'Respiratory Department, Ramón y Cajal Hospital, Universidad de Alcala, IRYCIS, Ctra. Colmenar Viejo, km. 9, 100, 28034 Madrid, Spain.'}, {'ForeName': 'Veli-Pekka', 'Initials': 'VP', 'LastName': 'Harjola', 'Affiliation': 'Emergency Medicine, University of Helsinki, Department of Emergency Medicine and Services, Helsinki University Hospital, Tukholmankatu 8A, 00290 Helsinki, Finland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Held', 'Affiliation': 'Department of Internal Medicine, Medical Mission Hospital, Academic Teaching Hospital of the Julius-Maximilian University of Wuerzburg, Josef-Schneider-Strasse 2, 97080 Wuerzburg, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Iogna Prat', 'Affiliation': 'Department of Emergency Medicine, Santa Maria della Misericordia Hospital, Piazzale Santa Maria della Misericordia 15, 33100 Udine, Italy.'}, {'ForeName': 'Tobias J', 'Initials': 'TJ', 'LastName': 'Lange', 'Affiliation': 'Department of Internal Medicine II, Division of Pneumology, University Medical Center Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Manolis', 'Affiliation': ""Department of Cardiology, General Hospital 'Asklepeion Voulas', Leof. Vasileos Pavlou 1, 166 73 Athens, Greece.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Kliniken Maria Hilf, Klinik für Pneumologie, Krankenhaus St. Franziskus, Viersener Str. 450, 41063 Mönchengladbach, Germany.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Mustonen', 'Affiliation': 'Department of Medicine, Keski-Suomi Central Hospital and University of Jyväskylä, Keskussairaalantie 19, 40620 Jyväskylä, Finland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Rauch-Kroehnert', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany; German Center for Cardiovascular Research (DZHK), Berlin, Germany.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ruiz-Artacho', 'Affiliation': 'Emergency Department, Clinico San Carlos Hospital, IdISSC, alle del Prof Martín Lagos, s/n, 28040 Madrid, Spain.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schellong', 'Affiliation': 'Vascular Center, Municipal Hospital of Dresden-Friedrichstadt, Friedrichstraße 41, 01067 Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schwaiblmair', 'Affiliation': 'Department of Cardiology, Respiratory Medicine and Intensive Care, Klinikum Augsburg, Ludwig-Maximilians-University Munich, Stenglinstrasse 2, 86156 Munich, Germany.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Stahrenberg', 'Affiliation': 'Helios Albert-Schweitzer-Klinik, Albert-Schweitzer-Weg 1, 37154 Northeim, Germany.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Westerweel', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Albert Schweitzerplaats 25, 3318 AT Dordrecht, The Netherlands.'}, {'ForeName': 'Philipp S', 'Initials': 'PS', 'LastName': 'Wild', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Stavros V', 'Initials': 'SV', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Lankeit', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz367']
1004,31112605,Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention.,"BACKGROUND AND OBJECTIVES


Social isolation is associated with a higher risk of dementia. We previously conducted and showed the efficacy of an intervention which uses conversation (the core component of social interactions) as a tool to enhance cognitive function. We now explore whether cognitive improvements through conversation-based intervention depend on an individual's personality.
RESEARCH DESIGN AND METHODS


We reexamined data from a 6-week randomized controlled trial (ClinicalTrials.gov Number: NCT01571427) to determine whether conversation-based intervention effects were moderated by personality traits in 83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment). The intervention group participated in daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks. At baseline, psychosocial questionnaires and a neuropsychological battery were completed.
RESULTS


Intervention group participants with high agreeableness, conscientiousness, and extraversion exhibited significant improvements in language-based executive function tasks beyond changes in the control group (ps < .05). An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
DISCUSSION AND IMPLICATIONS


Our exploratory findings suggest the adaptive role of personality traits in conversation-based cognitive interventions may be limited to tasks incorporating a language component, and offer initial evidence for personalized approaches to cognitive health in late life.",2020,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","['83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment']",['daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks'],"['language-based executive function tasks', 'Cognitive Function', 'delayed recall memory and working memory tasks']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",83.0,0.0918085,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Cerino', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hooker', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Goodrich', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}, {'ForeName': 'Hiroko H', 'Initials': 'HH', 'LastName': 'Dodge', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}]",The Gerontologist,['10.1093/geront/gnz063']
1005,31095318,Engaging Caregivers in Health-Related Housing Decisions for Older Adults With Cognitive Impairment: A Cluster Randomized Trial.,"BACKGROUND AND OBJECTIVES


Informal caregivers are rarely as involved as they want to be in the housing decisions of cognitively impaired older adults. Lack of awareness of available options and their benefits and risks may lead to decisions that do not reflect older adults' preferences, and to guilt and regret. We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
RESEARCH DESIGN AND METHODS


In a two-arm pragmatic cluster randomized trial with home care teams working in health centers in the Province of Quebec, we randomized health centers to receive training in interprofessional SDM (intervention) or not (control). Eligible caregivers had made a housing decision for a cognitively impaired adult aged 65 years or older who was receiving services from a home care team. The primary outcome was the proportion of caregivers reporting an active role in decision making. We performed intention-to-treat multilevel analysis.
RESULTS


We consecutively enrolled a random group of 16 health centers and recruited 309 caregivers, among whom 296 were included in the analysis. In the intervention arm, the proportion of caregivers reporting an active role in decision making increased by 12% (95% CI -2% to 27%; p = .10). After removal of an influential cluster outlier, the proportion increased to 18% (95% CI: 7%-29%; p < .01).
DISCUSSION AND IMPLICATIONS


Training home care teams in interprofessional SDM increased caregiver involvement in health-related housing decisions for cognitively impaired older adults.",2020,"We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
","['in health centers in the Province of Quebec', 'cognitively impaired older adults', 'consecutively enrolled a random group of 16 health centers and recruited 309 caregivers, among whom 296 were included in the analysis', 'Eligible caregivers had made a housing decision for a cognitively impaired adult aged 65 years or older who was receiving services from a home care team', 'Older Adults With Cognitive Impairment']","['home care teams working', 'training in interprofessional SDM (intervention) or not (control']",['proportion of caregivers reporting an active role in decision making'],"[{'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",,0.262906,"We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
","[{'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'Ottawa Hospital Research Institute and Faculty of Health Sciences, University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Brière', 'Affiliation': 'Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, Québec, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Freitas', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Mirjam M', 'Initials': 'MM', 'LastName': 'Garvelink', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Maman Joyce', 'Initials': 'MJ', 'LastName': 'Dogba', 'Affiliation': 'Department of Family Medicine and Emergency Medicine.'}, {'ForeName': 'Pierre J', 'Initials': 'PJ', 'LastName': 'Durand', 'Affiliation': 'Department of Family Medicine and Emergency Medicine.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': 'School of Nutrition, Québec, Canada.'}, {'ForeName': 'Jordie', 'Initials': 'J', 'LastName': 'Croteau', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Louis-Paul', 'Initials': 'LP', 'LastName': 'Rivest', 'Affiliation': 'Department of Mathematics and Statistics, Université Laval, Québec, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}]",The Gerontologist,['10.1093/geront/gnz045']
1006,31088505,POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth.,"BACKGROUND


High rates of preterm births remain a UK public health concern. Preterm birth is a major determinant of adverse infant and longer-term outcomes, including survival, quality of life, psychosocial effects on the family and health care costs. We aim to test whether a model of care combining continuity of midwife care with rapid referral to a specialist obstetric clinic throughout pregnancy, intrapartum and the postpartum period is feasible and improves experience and outcomes for women at increased risk of preterm birth.
METHODS


This pilot, hybrid, type 2 randomised controlled implementation trial will recruit 350 pregnant women at increased risk of preterm birth to a midwifery continuity of care intervention or standard care. The intervention will be provided from recruitment (antenatal), labour, birth and the postnatal period, in hospital and community settings and in collaboration with specialist obstetric clinic care, when required. Standard care will be the current maternity care provision by NHS midwives and obstetricians at the study site. Participants will be followed up until 6-8 weeks postpartum. The composite primary outcome is the appropriate initiation of any specified interventions related to the prevention and/or management of preterm labour and birth. Secondary outcomes are related to: recruitment and attrition rates; implementation; acceptability to women, health care professionals and stakeholders; health in pregnancy and other complications; intrapartum outcomes; maternal and neonatal postnatal outcomes; psycho-social health; quality of care; women's experiences and health economic analysis. The trial has 80% power to detect a 15% increase in the rate of appropriate interventions (40 to 55%). The analysis will be by 'intention to treat' analysis.
DISCUSSION


Little is known about the underlying reasons why and how models of midwifery continuity of care are associated with fewer preterm births, better maternal and infant outcomes and more positive experiences; nor how these models of care can be implemented successfully in the health services. This will be the first study to provide direct evidence regarding the effectiveness, implementation and evaluation of a midwifery continuity of care model and rapid access to specialist obstetric services for women at increased risk of preterm birth.
TRIAL REGISTRATION


ISRCTN37733900 . Retrospectively registered on 21 August 2017.",2019,"Preterm birth is a major determinant of adverse infant and longer-term outcomes, including survival, quality of life, psychosocial effects on the family and health care costs.","['350 pregnant women at increased risk of preterm birth to a midwifery continuity of care intervention or standard care', 'women at increased risk of preterm birth']",[],"['appropriate initiation of any specified interventions related to the prevention and/or management of preterm labour and birth', ""related to: recruitment and attrition rates; implementation; acceptability to women, health care professionals and stakeholders; health in pregnancy and other complications; intrapartum outcomes; maternal and neonatal postnatal outcomes; psycho-social health; quality of care; women's experiences and health economic analysis"", 'survival, quality of life, psychosocial effects on the family and health care costs', 'rate of appropriate interventions']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",350.0,0.255664,"Preterm birth is a major determinant of adverse infant and longer-term outcomes, including survival, quality of life, psychosocial effects on the family and health care costs.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fernandez Turienzo', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill, Coventry, CV4 7A, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bollard', 'Affiliation': 'Lewisham and Greenwich NHS Trust, Lewisham High Street, London, SE13 6HL, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brigante', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, James Clerk Maxwell Building, London, SE1 8WA, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Briley', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Coxon', 'Affiliation': ""Department of Midwifery, Kingston University and St. George's, University of London, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cross', 'Affiliation': 'Department of Public Health, London Borough of Lewisham, Laurence House, London, SE6 4RU, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""Centre for Implementation Science, Institute of Psychiatry, Psychology and Neuroscience, King's College London, David Goldberg Centre, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'Lewisham and Greenwich NHS Trust, Lewisham High Street, London, SE13 6HL, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Melaugh', 'Affiliation': ""Centre for Implementation Science, Institute of Psychiatry, Psychology and Neuroscience, King's College London, David Goldberg Centre, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Moulla', 'Affiliation': 'Lewisham and Greenwich NHS Trust, Lewisham High Street, London, SE13 6HL, UK.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Tribe', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, SE1 7EH, UK. jane.sandall@kcl.ac.uk.""}]",Trials,['10.1186/s13063-019-3352-1']
1007,31144430,"Postprandial hypoglycaemia after Roux-en-Y gastric bypass and the effects of acarbose, sitagliptin, verapamil, liraglutide and pasireotide.","AIM


To investigate the effects of acarbose, sitagliptin, verapamil, liraglutide and pasireotide on post-bariatric hypoglycaemia (PBH) after Roux-en-Y gastric bypass.
MATERIALS AND METHODS


In a randomized crossover study, 11 women who had undergone Roux-en-Y gastric bypass and had documented hypoglycaemia were each evaluated during a baseline period without treatment and during five treatment periods with the following interventions: acarbose 50 mg for 1 week, sitagliptin 100 mg for 1 week, verapamil 120 mg for 1 week, liraglutide 1.2 mg for 3 weeks and pasireotide 300 μg as a single dose. Treatment effects were evaluated by a mixed-meal tolerance test (MMTT) and, for all treatment periods except pasireotide, by 6 days of continuous glucose monitoring (CGM).
RESULTS


Treatment with acarbose and treatment with pasireotide both significantly lifted nadir glucose levels (mean ± SEM 3.9 ± 0.2 and 7.9 ± 0.4 vs 3.4 ± 0.2; P < .03) and reduced time in hypoglycaemia during the MMTTs. Acarbose reduced peak glucose levels and time in hyperglycaemia, whereas pasireotide greatly increased both variables. Acarbose and pasireotide reduced insulin and C-peptide levels, and pasireotide also diminished glucagon-like peptide-1 levels. Sitagliptin lowered nadir glucose values, while verapamil and liraglutide had no effect on hypoglycaemia. During the CGM periods, the treatments had no impact on hypoglycaemia, whereas acarbose and liraglutide reduced hyperglycaemia and glycaemic variability.
CONCLUSIONS


In an experimental setting, treatment with acarbose and pasireotide reduced PBH. Acarbose appears to have an overall glucose-stabilizing effect, whereas pasireotide leads to increased and sustained hyperglycaemia.",2019,"Acarbose and pasireotide reduced insulin and C-peptide levels, and pasireotide also diminished glucagon-like peptide-1 levels.",['11 women who had undergone Roux-en-Y gastric bypass and had documented hypoglycaemia'],"['acarbose', 'acarbose, sitagliptin, verapamil, liraglutide and pasireotide', 'Acarbose', 'acarbose and liraglutide', 'acarbose 50\u2009mg for 1\u2009week, sitagliptin 100\u2009mg for 1\u2009week, verapamil 120\u2009mg for 1\u2009week, liraglutide 1.2\u2009mg for 3\u2009weeks and pasireotide 300\u2009μg as a single dose']","['Postprandial hypoglycaemia', 'hyperglycaemia and glycaemic variability', 'hypoglycaemia', 'reduced time in hypoglycaemia', 'lifted nadir glucose levels', 'PBH', 'peak glucose levels and time in hyperglycaemia', 'nadir glucose values']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0982924', 'cui_str': 'Acarbose 50 MG'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0271710', 'cui_str': 'Postprandial Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",11.0,0.0147148,"Acarbose and pasireotide reduced insulin and C-peptide levels, and pasireotide also diminished glucagon-like peptide-1 levels.","[{'ForeName': 'Caroline Christfort', 'Initials': 'CC', 'LastName': 'Øhrstrøm', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Worm', 'Affiliation': 'Department of Medicine, Amager Hospital, Amager, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Højager', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Ditte', 'Initials': 'D', 'LastName': 'Andersen', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and Novo Nordisk Foundation Centre for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Urd Lynge', 'Initials': 'UL', 'LastName': 'Kielgast', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Dorte Lindqvist', 'Initials': 'DL', 'LastName': 'Hansen', 'Affiliation': 'Clinical Department, Steno Diabetes Center, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13796']
1008,31084994,Sertraline and Mirtazapine Versus Placebo in Subgroups of Depression in Dementia: Findings From the HTA-SADD Randomized Controlled Trial.,"OBJECTIVE


Studies have shown that antidepressants are no better than placebo in treating depression in dementia. The authors examined antidepressant efficacy in subgroups of depression in dementia with different depressive symptom profiles.
METHODS


This study focuses on exploratory secondary analyses on the randomized, parallel-group, double-blind, placebo-controlled Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial. The setting included old-age psychiatry services in nine centers in England. The participants included 326 patients meeting National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association probable/possible Alzheimer disease criteria, and Cornell Scale for Depression in Dementia (CSDD) scores of 8 or more. Intervention was placebo (n = 111), sertraline (n = 107), or mirtazapine (n = 108). Latent class analyses (LCA) on baseline CSDD items clustered participants into symptom-based subgroups. Mixed-model analysis evaluated CSDD improvement at 13 and 39 weeks by randomization in each subgroup.
RESULTS


LCA yielded 4 subgroups: severe (n = 34), psychological (n = 86), affective (n = 129), and somatic (n = 77). Mirtazapine, but not sertraline, outperformed placebo in the psychological subgroup at week 13 (adjusted estimate: -2.77 [standard error (SE) 1.16; 95% confidence interval: -5.09 to -0.46]), which remained, but lost statistical significance at week 39 (adjusted estimate: -2.97 [SE 1.59; 95% confidence interval: -6.15 to 0.20]). Neither sertraline nor mirtazapine outperformed placebo in the other subgroups.
CONCLUSION


Because of the exploratory nature of the analyses and the small sample sizes for subgroup analysis there is the need for caution in interpreting these data. Replication of the potential effects of mirtazapine in the subgroup of those with depression in dementia with ""psychological"" symptoms would be valuable. These data should not change clinical practice, but future trials should consider stratifying types of depression in dementia in secondary analyses.",2019,"Mirtazapine, but not sertraline, outperformed placebo in the psychological subgroup at week 13 (adjusted estimate:","['subgroup of those with depression in dementia with ""psychological"" symptoms', ""participants included 326 patients meeting National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association probable/possible Alzheimer disease criteria, and Cornell Scale for Depression in Dementia (CSDD) scores of 8 or more"", 'Subgroups of Depression in Dementia', 'subgroups of depression in dementia with different depressive symptom profiles']","['sertraline', 'placebo', 'standard error (SE', 'mirtazapine', 'Mirtazapine', 'Sertraline and Mirtazapine Versus Placebo']",['CSDD improvement'],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0009460', 'cui_str': 'Communicative Disorders'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]",[],326.0,0.512515,"Mirtazapine, but not sertraline, outperformed placebo in the psychological subgroup at week 13 (adjusted estimate:","[{'ForeName': 'Marij', 'Initials': 'M', 'LastName': 'Zuidersma', 'Affiliation': 'University Center of Psychiatry & Interdisciplinary Center of Psychopathology and Emotion Regulation (MZ, ROV), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Kia-Chong', 'Initials': 'KC', 'LastName': 'Chua', 'Affiliation': ""Health Service and Population Research Department (KCC), Institute of Psychiatry, Psychology & Neuroscience, King's College London, London.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hellier', 'Affiliation': ""Biostatistics & Health Informatics Department (JH), Institute of Psychiatry, Psychology & Neuroscience, King's College London, London.""}, {'ForeName': 'Richard Oude', 'Initials': 'RO', 'LastName': 'Voshaar', 'Affiliation': 'University Center of Psychiatry & Interdisciplinary Center of Psychopathology and Emotion Regulation (MZ, ROV), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Sube', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Centre for Dementia Studies (SB), Brighton & Sussex Medical School, University of Sussex, Brighton, East Sussex, United Kingdom. Electronic address: s.banerjee@bsms.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.03.021']
1009,31084640,Reduction in the occurrence of distressing involuntary memories following propranolol or hydrocortisone in healthy women.,"BACKGROUND


Pharmacological treatments targeting the neuroendocrine stress response may hold special promise in secondary prevention of posttraumatic stress disorder (PTSD). However, findings from clinical trials have been inconsistent and the efficacy of specific drugs, their temporal window of efficacy, effective doses and the characteristics of likely treatment responders remain unclear.
METHOD


Using an experimental human model of distressing involuntary memory formation, we compare the effects of two drugs that have theoretical or empirical support as secondary preventive agents in PTSD. Eighty-eight healthy women (average age: 23.5 years) received oral propranolol (80 mg), hydrocortisone (30 mg), or matched placebo immediately after viewing a 'trauma film'. They then completed daily, time-stamped intrusion diaries for 1 week, at the end of which, voluntary memory was tested.
RESULTS


While neither drug affected voluntary memory for the trauma narrative, propranolol treatment was associated with 42% fewer, and hydrocortisone with 55% fewer intrusions across the week, relative to placebo. Additionally, propranolol reduced general trauma-like symptoms, and post-drug cortisol levels were negatively correlated with intrusion frequency in the hydrocortisone group.
CONCLUSIONS


Overall, this study shows substantial reductions in intrusive memories and preserved voluntary narrative-declarative memory following either propranolol or hydrocortisone in an experimental model of psychological trauma. As such, despite some inconsistencies in clinical trials, our findings support continued investigation of propranolol and hydrocortisone as secondary preventive agents for re-experiencing symptoms of PTSD. The findings also suggest that it is critical for future research to identify the conditions governing the preventive efficacy of these drugs in PTSD.",2020,"RESULTS


While neither drug affected voluntary memory for the trauma narrative","['Eighty-eight healthy women (average age: 23.5 years', 'healthy women']","['propranolol or hydrocortisone', 'propranolol and hydrocortisone', 'oral propranolol', 'propranolol', 'hydrocortisone', 'hydrocortisone (30 mg), or matched placebo']","['general trauma-like symptoms, and post-drug cortisol levels', 'distressing involuntary memories', 'intrusive memories and preserved voluntary narrative-declarative memory']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}]",88.0,0.0430301,"RESULTS


While neither drug affected voluntary memory for the trauma narrative","[{'ForeName': 'Sunjeev K', 'Initials': 'SK', 'LastName': 'Kamboj', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'An Tong', 'Initials': 'AT', 'LastName': 'Gong', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'ZhiHui', 'Initials': 'Z', 'LastName': 'Sim', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'Adrihani A', 'Initials': 'AA', 'LastName': 'Rashid', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Baba', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Iskandar', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, UCLH, London, UK.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Das', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, LondonWC1E 6BT, UK.'}]",Psychological medicine,['10.1017/S0033291719001028']
1010,29705935,Project SHINE: effects of a randomized family-based health promotion program on the physical activity of African American parents.,"This study examined the effects of a family-based health promotion intervention on the moderate-to-vigorous physical activity (MVPA), light physical activity, sedentary behavior, and fruit and vegetable intake of African American parents. Eighty-nine African American parents (41.5 ± 8.5 years; 92% females; 74% obese; 64% < $40 K income) and adolescents (12.5 ± 1.4 years; 61% girls; 48% obese) were randomized to a 6-week behavioral skills plus positive parenting and peer monitoring intervention grounded in social cognitive, self-determination, and family systems theories or a general health comparison program. Parents wore accelerometers for 7 days and completed three 24-h dietary recalls at baseline and post-intervention. Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05). There were no other significant effects. Family-based approaches that include African American parents and youth may increase parent MVPA and hold promise for preventing chronic diseases.",2018,"Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05).","['African American parents and youth', 'African American parents', 'Eighty-nine African American parents (41.5\u2009±\u20098.5\xa0years; 92% females; 74% obese; 64%\u2009<\u2009$40\xa0K income) and adolescents (12.5\u2009±\u20091.4\xa0years; 61% girls; 48% obese']","['behavioral skills plus positive parenting and peer monitoring intervention grounded in social cognitive, self-determination, and family systems theories or a general health comparison program', 'randomized family-based health promotion program', 'family-based health promotion intervention']","['moderate-to-vigorous physical activity (MVPA), light physical activity, sedentary behavior, and fruit and vegetable intake', 'parent MVPA']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0303276', 'cui_str': 'K-40 radioisotope'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0039154', 'cui_str': 'Systems Theory'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",89.0,0.0135485,"Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite 1009, Miami, FL, 33136, USA. s.stgeorge@med.miami.edu.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': 'Department of Individual, Family, and Community Education, College of Education, University of New Mexico, Albuquerque, NM, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9926-7']
1011,31734798,Efficacy of a medication management service in improving adherence to tyrosine kinase inhibitors and clinical outcomes of patients with chronic myeloid leukaemia: a randomised controlled trial.,"PURPOSE


Suboptimal adherence to tyrosine kinase inhibitors (TKIs) contributes to poor clinical outcomes in chronic myeloid leukemia (CML). This randomised controlled trial (RCT) aimed to evaluate the impact of a medication management service (MMS) on adherence to TKIs and clinical outcomes.
METHODS


A parallel RCT was conducted in two hospitals in Malaysia, where 129 CML patients were randomised to MMS or control (usual care) groups using a stratified 1:1 block randomisation method. The 6-month MMS included three face-to-face medication use reviews, CML and TKI-related education, two follow-up telephone conversations, a printed information booklet and two adherence aids. Medication adherence (primary outcome), molecular responses and health-related quality of life (HRQoL) scores were assessed at baseline, 6th and 12th month. Medication adherence and HRQoL were assessed using medication possession ratio and the European Organisation for Research and Treatment in Cancer questionnaire (EORTC_QLQ30_CML24) respectively.
RESULTS


The MMS group (n = 65) showed significantly higher adherence to TKIs than the control group (n = 64) at 6th month (81.5% vs 56.3%; p = 0.002), but not at 12th month (72.6% vs 60.3%; p = 0.147). In addition, a significantly higher proportion of participants in the MMS group achieved major molecular response at 6th month (58.5% vs 35.9%; p = 0.010), but not at 12th month (66.2% vs 51.6%; p = 0.092). Significant deep molecular response was also obtained at 12th month (24.6% vs 10.9%; p = 0.042). Six out of 20 subscales of EORTC-QLQ30-CML24 were significantly better in the MMS group.
CONCLUSIONS


The MMS improved CML patients' adherence to TKI as well as achieved better clinical outcomes.
TRIAL REGISTRATION


Clinicaltrial.gov (ID: NCT03090477).",2020,"Six out of 20 subscales of EORTC-QLQ30-CML24 were significantly better in the MMS group.
","['two hospitals in Malaysia, where 129 CML patients', 'patients with chronic myeloid leukaemia', 'chronic myeloid leukemia (CML']","['medication management service (MMS', 'MMS or control (usual care', 'tyrosine kinase inhibitors (TKIs', 'medication management service']","['Significant deep molecular response', 'adherence to TKIs', 'Medication adherence and HRQoL', 'Medication adherence (primary outcome), molecular responses and health-related quality of life (HRQoL) scores', 'major molecular response']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",129.0,0.118383,"Six out of 20 subscales of EORTC-QLQ30-CML24 were significantly better in the MMS group.
","[{'ForeName': 'Bee Kim', 'Initials': 'BK', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siew Siang', 'Initials': 'SS', 'LastName': 'Chua', 'Affiliation': ""School of Pharmacy, Faculty of Health and Medical Sciences, Taylor's University, 47500, Subang Jaya, Selangor, Malaysia.""}, {'ForeName': 'Li-Chia', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}, {'ForeName': 'Kian Meng', 'Initials': 'KM', 'LastName': 'Chang', 'Affiliation': 'Department of Hematology, Ampang Hospital, 68000, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Sharmini', 'Initials': 'S', 'LastName': 'Balashanker', 'Affiliation': 'School of Pharmacy, University of Nottingham Malaysia Campus, 43500, Semenyih, Selangor, Malaysia.'}, {'ForeName': 'Ping Chong', 'Initials': 'PC', 'LastName': 'Bee', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia. pcbee@um.edu.my.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05133-0']
1012,31389835,"Comparing the McGrath Mac Video Laryngoscope and Direct Laryngoscopy for Prehospital Emergency Intubation in Air Rescue Patients: A Multicenter, Randomized, Controlled Trial.","OBJECTIVES


Tracheal intubation in prehospital emergency care is challenging. The McGrath Mac Video Laryngoscope (Medtronic, Minneapolis, MN) has been proven to be a reliable alternative for in-hospital airway management. This trial compared the McGrath Mac Video Laryngoscope and direct laryngoscopy for the prehospital setting.
DESIGN


Multicenter, prospective, randomized, controlled equivalence trial.
SETTING


Oesterreichischer Automobil- und Touring Club (OEAMTC) Helicopter Emergency Medical Service in Austria, 18-month study period.
PATIENTS


Five-hundred fourteen adult emergency patients (≥ 18 yr old).
INTERVENTIONS


Helicopter Emergency Medical Service physicians followed the institutional algorithm, comprising a maximum of two tracheal intubation attempts with each device, followed by supraglottic, then surgical airway access in case of tracheal intubation failure. No restrictions were given for tracheal intubation indication.
MEASUREMENTS MAIN RESULTS


The Primary outcome was the rate of successful tracheal intubation; equivalence range was ± 6.5% of success rates. Secondary outcomes were the number of attempts to successful tracheal intubation, time to glottis passage and first end-tidal CO2 measurement, degree of glottis visualization, and number of problems. The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39). There was no statistically significant difference with regard to tracheal intubation times, number of attempts or difficulty. The view to the glottis was significantly better, but the number of technical problems was increased with the McGrath Mac Video Laryngoscope. After a failed first tracheal intubation attempt, immediate switching of the device was significantly more successful than after the second attempt (90.5% vs 57.1%; p = 0.0003), regardless of the method.
CONCLUSIONS


Both devices are equivalently well suited for use in prehospital emergency tracheal intubation of adult patients. Switching the device following a failed first tracheal intubation attempt was more successful than a second attempt with the same device.",2019,"The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39).","['prehospital emergency tracheal intubation of adult patients', 'Oesterreichischer Automobil- und Touring Club (OEAMTC', 'Five-hundred fourteen adult emergency patients (≥ 18 yr old', 'Prehospital Emergency Intubation in Air Rescue Patients']","['McGrath Mac Video Laryngoscope and Direct Laryngoscopy', 'McGrath Mac Video Laryngoscope and direct laryngoscopy']","['tracheal intubation times, number of attempts or difficulty', 'success rate', 'number of attempts to successful tracheal intubation, time to glottis passage and first end-tidal CO2 measurement, degree of glottis visualization, and number of problems', 'number of technical problems', 'rate of successful tracheal intubation; equivalence range']","[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",514.0,0.185522,"The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39).","[{'ForeName': 'Janett', 'Initials': 'J', 'LastName': 'Kreutziger', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Hornung', 'Affiliation': 'Department of Anesthesiology, Emergency and Critical Care Medicine, Wiener Neustadt General Hospital, Wiener Neustadt, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Harrer', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Urschl', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Doppler', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Wolfgang G', 'Initials': 'WG', 'LastName': 'Voelckel', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Trimmel', 'Affiliation': 'Department of Anesthesiology, Emergency and Critical Care Medicine, Wiener Neustadt General Hospital, Wiener Neustadt, Austria.'}]",Critical care medicine,['10.1097/CCM.0000000000003918']
1013,31079146,"Safety Comparison of Two Enterovirus 71 (EV71) Inactivated Vaccines in Yiwu, China.","The safety of two kinds of post-marketing enterovirus 71 (EV71) vaccine in China was evaluated in this study. Fourteen vaccination clinics were randomly assigned in a 1:1 ratio, and both children in two groups were administered according to a two-dose schedule (on a 0 and 28 day schedule). Written informed consent was obtained, and recipients in this study were observed for 30 min after inoculation in the clinic, and then followed via phone or on-site follow-up at day 3 and 30. No severe EV71-associated adverse event was reported. No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556). There was no significant difference in the occurrence of adverse events among recipients aged less than 24 months; however, the proportion of adverse events was higher in Group CAMS than in Group Sinovac among the subjects aged 24-35 months (5.3% vs. 2.5%, p < 0.001). The two kinds of EV71 vaccines showed satisfactory safety. Adverse events after vaccination were normal and acceptable.",2019,"No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556).","['Fourteen vaccination clinics', 'Yiwu, China']",['Two Enterovirus 71 (EV71) Inactivated Vaccines'],"['satisfactory safety', 'proportion of adverse events', 'Adverse events', 'occurrence of adverse events']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0338051', 'cui_str': 'Vaccination clinic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.0379054,"No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556).","[{'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Fu', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Weibiao', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Lingqiao', 'Initials': 'L', 'LastName': 'Lou', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz004']
1014,31738448,Intra- and inter-Individual variability in nerve block duration: A randomized cross-over trial in the common peroneal nerve of healthy volunteers.,"BACKGROUND


The reported variation in nerve block duration is considerable. To individualize nerve block therapy, knowledge of the intra- vs inter-individual variability is essential. We investigated the relative contribution of these 2 parameters to the overall nerve block duration variability.
METHODS


With ethics committee approval, we conducted a randomized cross-over trial where 20 healthy volunteers received 8 common peroneal nerve blockades with lidocaine 0.5% on 4 consecutive days. Allocations were 5 mL to either the right or left side and 10 mL to the opposite side on day 1 and 2 and vice versa on day 3 and 4. With fixed needle entry and nerve target, we repeated local anaesthetic deposition for each blockade. The primary outcome was variation in duration of sensory nerve block defined as insensitivity to a cold stimulus. Data were analysed using linear mixed model regression.
RESULTS


The mean sensory block duration of 380 (95% CI = [342; 418]) minutes on day one was 55 [33; 77] minutes longer than on day two (P < .001), but there were no differences in mean duration between days 2, 3 and 4. The ratios with 2.5; 97.5 percentiles between inter- and intra-individual variation were 2.4 [0.8; 5.2] for the 5 mL blockades and 3.0 [0.9; 6.7] for the 10 mL blockades. The probabilities of inter- to intra-individual variation-ratios >1 were 96% and 97%.
CONCLUSION


The intra-individual variability is a substantially minor contributor to the overall variability in sensory nerve block duration compared with the inter-individual variability.",2020,"The mean sensory block duration of 380 (95% CI = [342; 418]) minutes on day one was 55 [33; 77] minutes longer than on day two (P < 0.001), but there were no differences in mean duration between days two, three and four.","['healthy volunteers', 'twenty healthy volunteers', 'nerve block duration']",['lidocaine'],"['variation in duration of sensory nerve block defined as insensitivity to a cold stimulus', 'mean sensory block duration', 'mean duration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",20.0,0.140519,"The mean sensory block duration of 380 (95% CI = [342; 418]) minutes on day one was 55 [33; 77] minutes longer than on day two (P < 0.001), but there were no differences in mean duration between days two, three and four.","[{'ForeName': 'Mikkel H', 'Initials': 'MH', 'LastName': 'Madsen', 'Affiliation': 'Department of Anaesthesiology, Nordsjaellands Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Claus B', 'Initials': 'CB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Anaesthesiology, Nordsjaellands Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Mølleskov', 'Affiliation': 'Department of Anaesthesiology, Nordsjaellands Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rothe', 'Affiliation': 'Department of Anaesthesiology, Nordsjaellands Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Andreas E K', 'Initials': 'AEK', 'LastName': 'Jensen', 'Affiliation': 'Institute of Public Health, Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lundstrøm', 'Affiliation': 'Department of Anaesthesiology, Nordsjaellands Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Kai H W', 'Initials': 'KHW', 'LastName': 'Lange', 'Affiliation': 'Department of Anaesthesiology, Nordsjaellands Hospital, University of Copenhagen, Hillerød, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13512']
1015,31004689,Improved balance performance accompanied by structural plasticity in blind adults after training.,"Postural control requires the sensory integration of visual, vestibular, and proprioceptive signals. In the absence of vision, either by blindfolding or in blind individuals, balance performance is typically poorer than with sight. Previous research has suggested that despite showing compensatory vestibular and proprioceptive processing during upright standing, balance performance in blind individuals is overall lower than in sighted controls with eyes open. The present study tested whether balance training, which places demands on vestibular and proprioceptive self-motion perception, improves balance performance in blind adults, and whether we find similar structural correlates in cortical and subcortical brain areas as have been reported in sighted individuals. Fourteen congenitally or late blind adults were randomly assigned to either a balance or a relaxation group and exercised twice a week for 12 weeks. Assessments prior to and after training included balance tests and the acquisition of T1-weighted MRI images. The blind balance group significantly improved in dynamic, static, and functional balance performance compared to the blind relaxation group. The balance performance improvement did not differ from that of age- and gender matched sighted adults after balance training. Cortical thickness increased in the left parahippocampus and decreased in the inferior insula bilaterally in the blind balance group compared to the blind relaxation group. Thickness decreases in the insula were related to improved static and functional balance. Gray matter volume was reduced in the left hippocampus proper and increased in the right subiculum in the blind balance group. The present data suggest that impaired balance performance in blind adults can be significantly improved by a training inducing plasticity in brain regions associated with vestibular and proprioceptive self-motion processing.",2019,Gray matter volume was reduced in the left hippocampus proper and increased in the right subiculum in the blind balance group.,"['Fourteen congenitally or late blind adults', 'sighted individuals']","['balance training, which places demands on vestibular and proprioceptive self-motion perception', 'relaxation group and exercised twice']","['balance performance', 'Cortical thickness', 'dynamic, static, and functional balance performance', 'Gray matter volume', 'balance performance improvement', 'static and functional balance']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026598', 'cui_str': 'Motion Perception'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.0315564,Gray matter volume was reduced in the left hippocampus proper and increased in the right subiculum in the blind balance group.,"[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Rogge', 'Affiliation': 'Universität Hamburg, Biological Psychology and Neuropsychology, Von-Melle-Park 11, 20146, Hamburg, Germany. Electronic address: ann-kathrin.rogge@uni-hamburg.de.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Hötting', 'Affiliation': 'Universität Hamburg, Biological Psychology and Neuropsychology, Von-Melle-Park 11, 20146, Hamburg, Germany. Electronic address: Kirsten.Hoetting@uni-hamburg.de.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Nagel', 'Affiliation': 'Universität Hamburg, Sports Medicine, Turmweg 2, 20146, Hamburg, Germany. Electronic address: Volker.Nagel@uni-hamburg.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Friedrich Schiller University, Human Movement Science, Seidelstraße 20, 07749, Jena, Germany. Electronic address: astrid.zech@uni-jena.de.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Hölig', 'Affiliation': 'Friedrich Schiller University, Human Movement Science, Seidelstraße 20, 07749, Jena, Germany. Electronic address: Cordula.Hoelig@uni-hamburg.de.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Röder', 'Affiliation': 'Universität Hamburg, Biological Psychology and Neuropsychology, Von-Melle-Park 11, 20146, Hamburg, Germany. Electronic address: Brigitte.Roeder@uni-hamburg.de.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2019.04.005']
1016,31078402,Short-Term Effects of Branched-Chain Amino Acids-Enriched Dialysis Fluid on Branched-Chain Amino Acids Plasma Level and Mass Balance: A Randomized Cross-Over Study.,"OBJECTIVE(S)


The hemodialysis (HD) session per se is a catabolic event contributing to protein-energy wasting via several mechanisms including nutrient losses. Amino acids (AAs) losses in the dialysate are estimated from 6 to 10 g per treatment. The HD patient plasma AA concentration is usually lower than in normal subjects. This is even more marked in patients with long dialysis vintage or malnutrition.
METHODS


The aim of the study was to evaluate the effect on mass balance of a branched-chain AA (BCAA)-enriched (valine, isoleucine, leucine) dialysis fluid in a group of 6 stable HD anuric patients, fasting since 12 hours. The specific choice of BCAA relied on their key role on protein and muscle anabolism and their usual decreased plasma concentration in HD patients. Each patient was prescribed in a cross-over design and random order, either receiving a standard high-flux HD or an HD treatment using a BCAA-enriched acid concentrate designed to achieve a physiological plasma concentration of BCAAs. HD prescription remained unchanged during the 2 phases of study. Dialysate electrolytes prescription was kept constant for each individual patient, as well as dialysate glucose concentration (5.5 mmol/L). Pre- and post-dialysis BCAAs concentrations were measured by Ion-Exchange Liquid Chromatography. Postdialysis concentrations were corrected for hemoconcentration, and net mass transfer was calculated.
RESULTS


Six stable prevalent end-stage kidney disease patients were studied. They consisted of 5 men and 1 woman, aged 69.9 years, with body mass index of 25.2 kg/m 2 . Treatment schedule consisted of treatment time 4 hours, high-flux polysulfone membrane (1.8 m 2 ), blood flow 350 mL/minute, and dialysate/blood flow ratio at 1.5. The average BCAAs concentration in dialysate was targeted to physiological levels and assessed in 6 different samples, respectively for plasma valine, isoleucine, and leucine at 271, 78, and 145 μmol/L. With standard dialysate, plasma valine decreased from 204.5 to 130.8 (P = .0014). Plasma isoleucine and leucine changes were not significant, respectively from 65.7 to 59.3 μmol/L and 110.3 to 113.4 μmol/L. When using the BCAA-enriched dialysis fluid, plasma valine increased from 197.2 to 269.2 μmol/L (P = .0001), plasma isoleucine and leucine respectively from 63.2 to 84.7 (P = .0022) and from 107.2 to 161.6 μmoles/L (P = .0002). Dialysis dose estimated from KT/V did not differ between the sessions. The mass transfer with BCAA-enriched dialysate was +115, +16, and + 83 μmol per session for leucine, isoleucine, and valine, respectively.
CONCLUSION(S)


In conclusion, the addition of BCAAs at physiological concentration in the dialysis fluid contributes to restore physiological plasma concentrations for valine, isoleucine, and leucine at the end of a dialysis session. As BCAAs are essential to muscle balance, this could help to limit losses of BCAAs, restore physiological BCAAs concentrations, and decrease muscle catabolism observed during the HD treatment. Further outcome-based studies are needed to confirm this hypothesis on a larger scale and longer treatment time.",2020,"With standard dialysate, plasma valine decreased from 204.5 to 130.8 (P = .0014).","['Six stable prevalent end-stage kidney disease patients', 'patients with long dialysis vintage or malnutrition', 'a group of 6 stable HD anuric patients, fasting since 12\xa0hours', 'HD patients', '5 men and 1 woman, aged 69.9\xa0years, with body mass index of 25.2\xa0kg/m 2 ']","['Branched-Chain Amino Acids-Enriched Dialysis Fluid', 'branched-chain AA (BCAA)-enriched (valine, isoleucine, leucine) dialysis fluid']","['HD patient plasma AA concentration', 'Amino acids (AAs) losses', 'Pre- and post-dialysis BCAAs concentrations', 'Branched-Chain Amino Acids Plasma Level and Mass Balance', 'plasma valine', 'Postdialysis concentrations', 'muscle catabolism', 'Plasma isoleucine and leucine changes', 'dialysate glucose concentration', 'average BCAAs concentration', 'plasma isoleucine and leucine', 'HD prescription', 'dialysis fluid, plasma valine']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C0042285', 'cui_str': 'L-valine'}, {'cui': 'C0022192', 'cui_str': 'L-isoleucine'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1264635', 'cui_str': 'Post-dialysis'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0042285', 'cui_str': 'L-valine'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0022192', 'cui_str': 'L-isoleucine'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",5.0,0.0405103,"With standard dialysate, plasma valine decreased from 204.5 to 130.8 (P = .0014).","[{'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Deleaval', 'Affiliation': 'NephroCare Tassin-Charcot, Sainte-Foy-Les-Lyon, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Luaire', 'Affiliation': ""Fresenius-SMAD, L'Arbresle, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Laffay', 'Affiliation': ""Fresenius-SMAD, L'Arbresle, France.""}, {'ForeName': 'Dorine', 'Initials': 'D', 'LastName': 'Jambut-Cadon', 'Affiliation': 'A.R.C en Ciel, Basse-Goulaine, France.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Stauss-Grabo', 'Affiliation': 'Center of Excellence Medical, FMC EMEA, Bad Homburg, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Canaud', 'Affiliation': 'Center of Excellence Medical, FMC EMEA, Bad Homburg, Germany.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chazot', 'Affiliation': 'NephroCare Tassin-Charcot, Sainte-Foy-Les-Lyon, France. Electronic address: chchazot@gmail.com.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.03.079']
1017,2970744,[Prophylactic efficacy of reaferon in viral hepatitis A and acute respiratory infections in children].,"Reaferon, the analog of human alpha 2-interferon obtained by gene engineering techniques, was studied with a view to its use for the prevention of hepatitis A. The study involved children of preschool age in Tashkent. In a strictly controlled trial children aged 2-6 years received the preparation orally in a dose of 1 X 10(6) I. U. or the diluent alone used as placebo. The preparation was administered to 1,100 children and the placebo to 1,078 children. The preparation and placebo were administered twice a week for two months. On the whole, during that period hepatitis A morbidity in both test and control groups of children was the same (5.1% and 4.9% respectively), but among children of nursery age receiving Reaferon the incidence of hepatitis A and acute respiratory viral infections was lower than among those receiving the placebo, though this difference was statistically significant only for cases of acute respiratory infections.",1988,"On the whole, during that period hepatitis A morbidity in both test and control groups of children was the same (5.1% and 4.9% respectively), but among children of nursery age receiving Reaferon the incidence of hepatitis A and acute respiratory viral infections was lower than among those receiving the placebo, though this difference was statistically significant only for cases of acute respiratory infections.","['to 1,078 children', 'children', 'trial children aged 2-6 years', 'children of preschool age in Tashkent']","['reaferon', 'placebo']",['hepatitis A and acute respiratory viral infections'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}]","[{'cui': 'C0073010', 'cui_str': 'Reaferon'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019159', 'cui_str': 'Hepatitis, Infectious'}, {'cui': 'C0042769', 'cui_str': 'Viral Infections'}]",1100.0,0.123662,"On the whole, during that period hepatitis A morbidity in both test and control groups of children was the same (5.1% and 4.9% respectively), but among children of nursery age receiving Reaferon the incidence of hepatitis A and acute respiratory viral infections was lower than among those receiving the placebo, though this difference was statistically significant only for cases of acute respiratory infections.","[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Iuldashev', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Slepushkin', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Khodzhaeva', 'Affiliation': ''}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Schastnyĭ', 'Affiliation': ''}, {'ForeName': 'F Kh', 'Initials': 'FKh', 'LastName': 'Kamilov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1018,31738342,"Enteropathogens and Rotavirus Vaccine Immunogenicity in a Cluster Randomized Trial of Improved Water, Sanitation and Hygiene in Rural Zimbabwe.","BACKGROUND


Oral rotavirus vaccines (RVVs) are less efficacious in low-income versus high-income settings, plausibly due to more enteropathogen exposure through poor water, sanitation and hygiene (WASH). We explored associations between enteropathogens and RVV immunogenicity and evaluated the effect of improved WASH on enteropathogen carriage.
METHODS


We detected stool enteropathogens using quantitative molecular methods and measured anti-rotavirus immunoglobulin A by enzyme-linked immunosorbent assay in infants enrolled to a cluster randomized 2 × 2 factorial trial of improved WASH and improved infant feeding in Zimbabwe (NCT01824940). We used multivariable regression to explore associations between enteropathogens and RVV seroconversion, seropositivity and geometric mean titer. We evaluated effects of improved WASH on enteropathogen prevalence using linear and binomial regression models with generalized estimating equations.
RESULTS


Among 224 infants with enteropathogen and immunogenicity data, 107 (47.8%) had ≥1 pathogen and 39 (17.4%) had ≥2 pathogens detected at median age 41 days (interquartile range: 35-54). RVV seroconversion was low (23.7%). After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96). There were otherwise no meaningful associations between individual or total pathogens (bacteria, viruses, parasites or all pathogens) and any measure of RVV immunogenicity. Enteropathogen detection did not differ between randomized WASH and non-WASH groups.
CONCLUSIONS


Enteropathogen infections were common around the time of rotavirus vaccination in rural Zimbabwean infants but did not explain poor RVV immunogenicity and were not reduced by a package of household-level WASH interventions.",2019,"After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96).","['224 infants with enteropathogen and immunogenicity data, 107 (47.8%) had ≥1 pathogen and 39 (17.4%) had ≥2 pathogens detected at median age 41 days (interquartile range: 35-54', 'rural Zimbabwean infants', 'Rural Zimbabwe']","['WASH', 'quantitative molecular methods and measured anti-rotavirus immunoglobulin A by enzyme-linked immunosorbent assay', 'Oral rotavirus vaccines (RVVs']","['enteropathogens and RVV seroconversion, seropositivity and geometric mean titer', 'Enteropathogen detection', 'RVV seroconversion', 'RVV immunogenicity']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1562052', 'cui_str': 'Enteropathogen'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1562052', 'cui_str': 'Enteropathogen'}]",224.0,0.235107,"After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Church', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Taniuchi', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rukobo', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Govha', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002485']
1019,31074205,Addition of canagliflozin to insulin improves glycaemic control and reduces insulin dose in patients with type 2 diabetes mellitus: A randomized controlled trial.,"The aim of this study was to evaluate the efficacy of canagliflozin in reducing the required insulin dose and the risk of hypoglycaemia in type 2 diabetes (T2D). This study was conducted in patients with T2D treated with insulin. They were randomly assigned to the control (n = 17) and canagliflozin (n = 17, plus 100 mg/day canagliflozin) groups. In both groups, a defined insulin dose adjustment protocol was applied to achieve the same level of glycaemic control. The change from baseline in daily insulin dose was significantly smaller in the canagliflozin group (3.9 units/day) than in the control group (13.4 units/day; P = 0.040). Low blood glucose index and predicted % of blood glucose (BG) <70 mg/dL, which are hypoglycaemia-related variables, worsened significantly in the control group but both remained unchanged in the canagliflozin group. The standard deviation for night-time BG levels improved significantly only in the canagliflozin group. Supplementation of insulin therapy with 100 mg canagliflozin in patients with T2D reduced the required insulin dose and hypoglycaemic risk and flattened night-time glycaemic fluctuations while maintaining the same level of glycaemic control.",2019,The standard deviation for night-time BG levels improved significantly only in the canagliflozin group.,"['patients with T2D', 'patients with type 2 diabetes mellitus', 'patients with T2D treated with insulin', 'type 2 diabetes (T2D']","['canagliflozin', 'canagliflozin (n\u2009=\u200917, plus 100\u2009mg/day canagliflozin', 'insulin therapy with 100\u2009mg canagliflozin', 'canagliflozin to insulin']","['blood glucose (BG', 'daily insulin dose', 'required insulin dose and hypoglycaemic risk and flattened night-time glycaemic fluctuations', 'standard deviation for night-time BG levels', 'Low blood glucose index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0461365,The standard deviation for night-time BG levels improved significantly only in the canagliflozin group.,"[{'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Goshima', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Tokutsu', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13770']
1020,31733990,"Efficacy, safety, and tolerability of mirabegron in patients aged ≥65yr with overactive bladder wet: a phase IV, double-blind, randomised, placebo-controlled study (PILLAR).","BACKGROUND


The majority of patients with overactive bladder (OAB) are aged >65yr. There has been no prospectively designed study assessing treatment efficacy with the β3-adrenoreceptor agonist, mirabegron, specifically in this age group.
OBJECTIVE


A phase IV study comparing flexibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence.
DESIGN, SETTING, AND PARTICIPANTS


Community-dwelling patients aged ≥65yr with OAB for ≥3mo.
INTERVENTION


Following a 2-wk placebo run in, patients with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/24h were randomised 1:1 to double-blind 25mg/d mirabegron or matched placebo, for 12wk. After week 4 or 8, the dose could be increased to 50mg/d mirabegron/matched placebo based on patient and investigator discretion.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Coprimary endpoints: change from baseline to end of treatment (EOT) in the mean numbers of micturitions/24h and incontinence episodes/24h. Secondary endpoints: change from baseline to EOT in the mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Analysis of covariance (ANCOVA) was used for the mean number of micturitions/24h, mean volume voided/micturition, and mean number of urgency episodes/24h. Stratified rank ANCOVA was used for the mean numbers of incontinence episodes/24h and urgency incontinence episodes/24h.
RESULTS AND LIMITATIONS


Statistically significant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24h, mean number of incontinence episodes/24h, mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Safety and tolerability were consistent with the known mirabegron safety profile.
CONCLUSIONS


Mirabegron efficacy, safety, and tolerability over 12 wk were confirmed in patients aged ≥65yr with OAB and incontinence.
PATIENT SUMMARY


We examined the effect of mirabegron compared with placebo in people aged 65yr or older with overactive bladder and incontinence. Mirabegron improved the symptoms of overactive bladder compared with placebo. Side effects were similar to those already known for mirabegron.",2020,"Statistically significant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24h, mean number of incontinence episodes/24h, mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h.","['patients aged ≥65yr with overactive bladder wet', 'Community-dwelling patients aged ≥65yr with OAB for ≥3mo', 'patients with overactive bladder (OAB) are aged >65yr', 'elderly patients with OAB and urgency incontinence', 'patients aged ≥65yr with OAB and incontinence', 'people aged 65yr or older with overactive bladder and incontinence']",['placebo'],"['Mirabegron efficacy, safety, and tolerability', 'symptoms of overactive bladder', 'Efficacy, safety, and tolerability of mirabegron', 'mean number of micturitions/24h, mean number of incontinence episodes/24h, mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h', 'Side effects', 'mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h', 'Safety and tolerability', 'baseline to EOT in the mean volume voided/micturition', 'baseline to end of treatment (EOT) in the mean numbers of micturitions/24h and incontinence episodes/24h']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.277888,"Statistically significant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24h, mean number of incontinence episodes/24h, mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Geriatric Medicine, University of Alberta, Edmonton, Alberta, Canada. Electronic address: adrian.wagg@ualberta.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': ""Division of Urology, St Elizabeth's Medical Center, Boston, MA, USA.""}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Engel', 'Affiliation': 'Bayview Research Group, LLC, Valley Village, CA, USA.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Schermer', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}]",European urology,['10.1016/j.eururo.2019.10.002']
1021,30475006,Perspectives on a contingency management intervention for alcohol use among consumers with serious mental illness.,"OBJECTIVE


This study describes the perspectives of outpatients with serious mental illness (SMI) and alcohol dependence on their participation in a contingency management (CM) intervention for alcohol use.
METHODS


Thirty-five adults with SMI and alcohol dependence participated in a randomized trial of CM for alcohol use, where they were rewarded with prizes contingent on abstinence from alcohol. All participants were interviewed regarding their participation in CM with a consistent structure that included nine open-ended questions. Favored and disliked aspects of CM, perception of alcohol biomarker accuracy, and interest in participating in similar CM interventions provided by treatment centers, rather than researchers, were explored.
RESULTS


Participants spoke enthusiastically about receiving prizes, as well as how CM increased their awareness of drinking and helped support their abstinence from alcohol. Most participants felt the ethyl glucuronide biomarker urine tests used to measure alcohol use were accurate, and they were interested in enrolling in CM if it was offered as a clinical program. Research staff who implemented the intervention were well regarded by participants, and interactions with research staff were perceived positively.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


Adults with SMI and alcohol dependence participating in a trial of CM for alcohol use reported overall positive perceptions of and experiences with CM. Receiving small tangible prizes and having positive interpersonal interactions with study staff were reported as especially impactful. These findings indicate that CM is well received by consumers, in addition to its empirical and practical benefits as an evidence-based, low-cost intervention. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"RESULTS


Participants spoke enthusiastically about receiving prizes, as well as how CM increased their awareness of drinking and helped support their abstinence from alcohol.","['Thirty-five adults with SMI and alcohol dependence participated in a randomized trial of CM for alcohol use, where they were rewarded with prizes contingent on abstinence from alcohol', 'consumers with serious mental illness', 'outpatients with serious mental illness (SMI) and alcohol dependence on their participation in a contingency management (CM) intervention for alcohol use', 'Adults with SMI and alcohol dependence participating']",['contingency management intervention'],[],"[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]",[],[],35.0,0.0309629,"RESULTS


Participants spoke enthusiastically about receiving prizes, as well as how CM increased their awareness of drinking and helped support their abstinence from alcohol.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Leickly', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Skalisky', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Angelo', 'Affiliation': 'School of Public Health, University of Washington.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Srebnik', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Roll', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000330']
1022,19622592,A double-blind randomized phase II study on the efficacy of topical eye treatment in the prevention of docetaxel-induced dacryostenosis.,"BACKGROUND


Dacryostenosis is a common side-effect of weekly docetaxel (Taxotere). We investigate the efficacy of eyedrops containing corticosteroids (CS) versus artificial tears (AT) in patients receiving weekly docetaxel in the prevention of dacryostenosis.
PATIENTS AND METHODS


Twenty patients receiving weekly docetaxel were evaluated. Forty eyes were double-blind randomized: AT in one eye and CS in the other eye were administered, six times daily, throughout the docetaxel administration. Patients were assessed for tearing and stenosis at weeks 3, 6, 9 and 26. The primary end point was the incidence of dacryostenosis in each group at 9 weeks.
RESULTS


At 9 weeks, punctal or canalicular stenosis was observed in 9 of 20 (45%) of the CS eyes and 9 of 20 (45%) of the AT eyes. Dacryostenosis was mild in 37 of 40 eyes (93%) and severe in 3 of 40 eyes (8%), with equal distribution in the CS and AT group. Tearing was present in 9 of 20 (45%) of the CS eyes and 8 of 20 (40%) of the AT eyes, of which two eyes without stenosis in each group.
CONCLUSIONS


The incidence of dacryostenosis in patients receiving weekly docetaxel was not different for the AT- and the CS-treated eyes. The dacryostenosis was predominantly mild, not leading to surgical interventions.",2010,"Dacryostenosis was mild in 37 of 40 eyes (93%) and severe in 3 of 40 eyes (8%), with equal distribution in the CS and AT group.","['patients receiving weekly docetaxel in the prevention of dacryostenosis', 'Forty eyes were double-blind randomized', 'Twenty patients receiving weekly']","['docetaxel (Taxotere', 'docetaxel', 'eyedrops containing corticosteroids (CS) versus artificial tears (AT']","['Dacryostenosis', 'incidence of dacryostenosis', 'punctal or canalicular stenosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",40.0,0.0968066,"Dacryostenosis was mild in 37 of 40 eyes (93%) and severe in 3 of 40 eyes (8%), with equal distribution in the CS and AT group.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Leyssens', 'Affiliation': 'Departments of Ophthalmology. Electronic address: barbara.leyssens@gmail.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'Departments of Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Lobelle', 'Affiliation': 'Departments of Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gillis', 'Affiliation': 'Departments of Ophthalmology.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Paridaens', 'Affiliation': 'Departments of Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mombaerts', 'Affiliation': 'Departments of Ophthalmology.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp319']
1023,31074827,Exclusive Breast Milk vs. Hybrid Milk Feeding for Preterm Babies-A Randomized Controlled Trial Comparing Time to Full Feeds.,"When breastmilk is insufficient to meet planned feed volumes, neonatologists need to continue parenteral nutrition (PN) or use formula. This trial conducted at a tertiary care unit in South India between August 2014 and April 2016 compared time to full feeds in preterms fed 'mother's milk alone(MM)' vs. 'hybrid feed-mother's milk supplemented with formula(HF)'. We also compared time to regain birth weights, duration of PN, feed intolerance, Necrotizing Enterocolitis stage 2 or more, all-cause mortality, Extrauterine growth restriction, Healthcare associated infections, exclusive breast milk feeding rates at discharge, Retinopathy of prematurity requiring laser therapy, abnormal neurosonogram and oxygen dependency at 28 days. Neonates between 27 and 32 weeks were randomized into MM/HF when breast milk was insufficient. HF received formula to reach targeted feed volumes. MM received more PN to meet fluid requirements. 54 babies were analyzed in MM and 58 in HF. Time to full feeds were similar-MM (14.1 ± 4 days); HF (13.5 ± 4 days), p = 0.45. Exclusive breast milk feeding rates at discharge were higher in MM when compared to HF (74% vs. 51%). Other secondary outcomes were similar between groups. When mother's milk is unavailable in sufficient quantities, preterm babies may receive hybrid feeds. (Clinical trials registry of India no. REF/2016/02/006622).",2020,Exclusive breast milk feeding rates at discharge were higher in MM when compared to HF (74% vs. 51%).,"['Neonates between 27 and 32\u2009weeks', 'tertiary care unit in South India between August 2014 and April 2016 compared time to', 'Preterm Babies']","['MM/HF', 'Exclusive Breast Milk vs. Hybrid Milk Feeding', ""full feeds in preterms fed 'mother's milk alone(MM)' vs. 'hybrid feed-mother's milk supplemented with formula(HF""]","['time to regain birth weights, duration of PN, feed intolerance, Necrotizing Enterocolitis stage 2 or more, all-cause mortality, Extrauterine growth restriction, Healthcare associated infections, exclusive breast milk feeding rates at discharge, Retinopathy of prematurity requiring laser therapy, abnormal neurosonogram and oxygen dependency']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]",54.0,0.111584,Exclusive breast milk feeding rates at discharge were higher in MM when compared to HF (74% vs. 51%).,"[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Nandakumar', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, India.'}, {'ForeName': 'Femitha', 'Initials': 'F', 'LastName': 'Pournami', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, India.'}, {'ForeName': 'Jyothi', 'Initials': 'J', 'LastName': 'Prabhakar', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, India.'}, {'ForeName': 'P M C', 'Initials': 'PMC', 'LastName': 'Nair', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz028']
1024,31735560,"Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.","BACKGROUND


Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma.
METHODS


We did a randomised, multicentre, open-label, phase 3 study at 102 hospitals in 24 countries in Europe, North America, and the Asia-Pacific regions. Eligible participants were adult patients with relapsed and refractory multiple myeloma who had received at least two previous lines of treatment, including lenalidomide and a proteasome inhibitor. Patients were excluded if they were refractory to previous treatment with an anti-CD38 monoclonal antibody. We randomly assigned patients (1:1) to either isatuximab 10 mg/kg plus pomalidomide 4 mg plus dexamethasone 40 mg (20 mg for patients aged ≥75 years), or pomalidomide 4 mg plus dexamethasone 40 mg. Randomisation was done using interactive response technology and stratified according to the number of previous lines of treatment (2-3 vs >3) and age (<75 years vs ≥75 years). Treatments were assigned based on a permuted blocked randomisation scheme with a block size of four. The isatuximab-pomalidomide-dexamethasone group received isatuximab intravenously on days 1, 8, 15, and 22 in the first 28-day cycle, then on days 1 and 15 in subsequent cycles. Both groups received oral pomalidomide on days 1 to 21 in each cycle, and oral or intravenous dexamethasone on days 1, 8, 15, and 22 of each cycle. Treatment continued until disease progression, unacceptable toxicity, or consent withdrawal. Dose reductions for adverse reactions were permitted for pomalidomide and dexamethasone, but not for isatuximab. The primary endpoint was progression-free survival, determined by an independent response committee and assessed in the intention-to-treat population. Safety was assessed in all participants who received at least one dose of study drug. This study is registered at ClinicalTrials.gov, number NCT02990338.
FINDINGS


Between Jan 10, 2017, and Feb 2, 2018, we randomly assigned 307 patients to treatment: 154 to isatuximab-pomalidomide-dexamethasone, and 153 to pomalidomide-dexamethasone. At a median follow-up of 11·6 months (IQR 10·1-13·9), median progression-free survival was 11·5 months (95% CI 8·9-13·9) in the isatuximab-pomalidomide-dexamethasone group versus 6·5 months (4·5-8·3) in the pomalidomide-dexamethasone group; hazard ratio 0·596, 95% CI 0·44-0·81; p=0·001 by stratified log-rank test. The most frequent treatment-emergent adverse events (any grade; isatuximab-pomalidomide-dexamethasone vs pomalidomide-dexamethasone) were infusion reactions (56 [38%] vs 0), upper respiratory tract infections (43 [28%] vs 26 [17%]), and diarrhoea (39 [26%] vs 29 [20%]). Adverse events with a fatal outcome were reported in 12 patients (8%) in the isatuximab-pomalidomide-dexamethasone group and 14 (9%) in the pomalidomide-dexamethasone group. Deaths due to treatment-related adverse events were reported for one patient (<1%) in the isatuximab-pomalidomide-dexamethasone group (sepsis) and two (1%) in the pomalidomide-dexamethasone group (pneumonia and urinary tract infection).
INTERPRETATION


The addition of isatuximab to pomalidomide-dexamethasone significantly improves progression-free survival in patients with relapsed and refractory multiple myeloma. Isatuximab is an important new treatment option for the management of relapsed and refractory myeloma, particularly for patients who become refractory to lenalidomide and a proteasome inhibitor.
FUNDING


Sanofi. VIDEO ABSTRACT.",2019,"hazard ratio 0·596, 95% CI 0·44-0·81;","['Between Jan 10, 2017, and Feb 2, 2018', 'patients who become refractory to lenalidomide and a proteasome inhibitor', 'participants who received at least one dose of study drug', 'Patients were excluded if they were refractory to previous treatment with an anti-CD38 monoclonal antibody', 'patients with relapsed and refractory multiple myeloma (ICARIA-MM', '307 patients to treatment: 154 to', 'patients with relapsed and refractory multiple myeloma', 'Eligible participants were adult patients with relapsed and refractory multiple myeloma who had received at least two previous lines of treatment, including lenalidomide and a proteasome inhibitor', '102 hospitals in 24 countries in Europe, North America, and the Asia-Pacific regions']","['isatuximab 10 mg/kg plus pomalidomide 4 mg plus dexamethasone', 'pomalidomide-dexamethasone', 'isatuximab-pomalidomide-dexamethasone, and 153 to pomalidomide-dexamethasone', 'Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone', 'pomalidomide 4 mg plus dexamethasone', 'dexamethasone', 'isatuximab-pomalidomide-dexamethasone', 'isatuximab plus pomalidomide and dexamethasone', 'oral pomalidomide', 'pomalidomide and dexamethasone']","['Safety', 'progression-free survival', 'diarrhoea', 'Adverse events', 'median progression-free survival', 'Deaths', 'upper respiratory tract infections', 'progression-free survival benefit', 'adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1443643', 'cui_str': 'Proteasome Endopeptidase Complex Inhibitors'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3536424', 'cui_str': 'pomalidomide 4 MG'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",307.0,0.208808,"hazard ratio 0·596, 95% CI 0·44-0·81;","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': 'Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France. Electronic address: attal.michel@iuct-oncopole.fr.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: paul_richardson@dfci.harvard.edu.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clinical and Translational Medicine, Clínica Universidad de Navarra, Navarra, CIMA, IDISNA, CIBER-ONC, Pamplona, Spain.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': '1st Department of Medicine, Department of Hematology, First Faculty of Medicine Charles University and General Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Department of Haematology, CHU La Milétrie-Poitiers, Poitiers, France.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, Oslo, Norway; KG Jebsen Center for B cell malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Jeffrey Shang-Yi', 'Initials': 'JS', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Minarik', 'Affiliation': 'Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'H Miles', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': 'Cancer Immunology and Molecular Oncology, Epworth Healthcare, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Macé', 'Affiliation': 'Sanofi Research And Development, Vitry-Sur-Seine, France.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Corzo', 'Affiliation': 'Sanofi-Genzyme Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Campana', 'Affiliation': 'Sanofi-Genzyme Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Solenn', 'Initials': 'S', 'LastName': 'Le-Guennec', 'Affiliation': 'Sanofi Research And Development, Vitry-Sur-Seine, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Dubin', 'Affiliation': 'Sanofi Research And Development, Vitry-Sur-Seine, France.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32556-5']
1025,31547890,Moving toward community based telehealth services using mhealth for hypertensive patients.,"BACKGROUND


Although self-care can control and prevent complications in hypertensive patients, self-care adherence is relatively low among these patients. Community-based telehealth services through mhealth can be an effective solution.
OBJECTIVE


This study aimed to evaluate the effect and acceptance of an mhealth application as a community-based telehealth intervention on self-care behavior adherence.
METHOD


This clinical trial included sixty hypertensive patients and their matched controls from two heart clinics affiliated to Shiraz University of Medical Sciences (SUMS). Self-care behaviors were assessed using Hill-Bone questionnaire before and after the intervention. Acceptability was evaluated in the intervention group at the end of the study period. The data were analyzed via SPSS 18 software using descriptive and inferential statistics.
RESULT


The results showed a significant difference between the intervention and control groups regarding the mean score of self-care behaviors (4.13 ± 0.23 versus 3.18 ± 0.27, p < .001). Additionally, a significant difference was observed between the two groups concerning the mean scores of the two subscales of self-care behaviors, including ""medication taking"" and ""proper diet"". However, no significant difference was observed between the two groups regarding the mean score of ""appointment keeping"" (p = .075). Overall, the intervention group participants were satisfied (4.27 ± 0.34) with this approach for managing hypertension.
CONCLUSION


Community-based telehealth services through mhealth had the potential to improve self-care behaviors in hypertensive patients and seemed to be accepted by the patients in the intervention group.",2019,Community-based telehealth services through mhealth had the potential to improve self-care behaviors in hypertensive patients and seemed to be accepted by the patients in the intervention group.,"['hypertensive patients', 'sixty hypertensive patients and their matched controls from two heart clinics affiliated to Shiraz University of Medical Sciences (SUMS']",['Moving toward community based telehealth services'],"['mean score of ""appointment keeping', 'mean scores of the two subscales of self-care behaviors, including ""medication taking"" and ""proper diet', 'mean score of self-care behaviors', 'Self-care behaviors', 'Acceptability', 'self-care behaviors']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4520476', 'cui_str': 'Telehealth service'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",18.0,0.0176412,Community-based telehealth services through mhealth had the potential to improve self-care behaviors in hypertensive patients and seemed to be accepted by the patients in the intervention group.,"[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Health Information Management, Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rezaee', 'Affiliation': 'Department of Health Information Technology, Clinical Education Research Center, Human Resources Development Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Aslani', 'Affiliation': 'Department of Health Information Management, Human Resources Development Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shirdeli', 'Affiliation': 'Health Information Management, Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Kojuri', 'Affiliation': 'Clinical Education Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",International journal of technology assessment in health care,['10.1017/S0266462319000655']
1026,31043521,A phase 2 clinical trial of a vasopressin V1a receptor antagonist shows improved adaptive behaviors in men with autism spectrum disorder.,"There are no approved pharmacological therapies to address the core symptoms of autism spectrum disorder (ASD), namely, persistent deficits in social communication and social interaction and the presence of restricted, repetitive patterns of behaviors, interests, or activities. The neuropeptide vasopressin has been implicated in the regulation of social behaviors, and its modulation has emerged as a therapeutic target for ASD. The phase 2 VANILLA clinical trial reported here evaluated balovaptan, an orally administered selective vasopressin V1a receptor antagonist, in 223 men with ASD and intelligence quotient ≥70. The drug was administered daily for 12 weeks and was compared with placebo. Participants were randomized to placebo ( n  = 75) or one of three balovaptan dose arms (1.5 mg,  n  = 32; 4 mg,  n  = 77; 10 mg,  n  = 39). Balovaptan treatment was not associated with a change from baseline compared with placebo at 12 weeks in the primary efficacy endpoint (Social Responsiveness Scale, 2nd Edition). However, dose-dependent and clinically meaningful improvements on the Vineland-II Adaptive Behavior Scales composite score were observed for participants treated with balovaptan 4 or 10 mg compared with placebo. This was driven principally by improvements in the Vineland-II socialization and communication scores. Balovaptan was well tolerated across all doses, and no drug-related safety concerns were identified. These results support further study of balovaptan as a potential treatment for the socialization and communication deficits in ASD.",2019,"Balovaptan treatment was not associated with a change from baseline compared with placebo at 12 weeks in the primary efficacy endpoint (Social Responsiveness Scale, 2nd Edition).","['men with autism spectrum disorder', '223 men with ASD and intelligence quotient ≥70']","['balovaptan', 'placebo', 'Balovaptan', 'selective vasopressin V1a receptor antagonist', 'neuropeptide vasopressin', 'vasopressin V1a receptor antagonist']","['Vineland-II Adaptive Behavior Scales composite score', 'efficacy endpoint (Social Responsiveness Scale, 2nd Edition', 'adaptive behaviors']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0284725', 'cui_str': 'Vasopressin Type 1A Receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}]","[{'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}, {'cui': 'C0222045'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}]",223.0,0.105261,"Balovaptan treatment was not associated with a change from baseline compared with placebo at 12 weeks in the primary efficacy endpoint (Social Responsiveness Scale, 2nd Edition).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bolognani', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Valle Rubido', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Squassante', 'Affiliation': 'Product Development, F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wandel', 'Affiliation': 'Product Development, F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Derks', 'Affiliation': 'Roche Pharma Research and Early Development, Roche Innovation Center Welwyn, Roche Products Ltd., Welwyn, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Murtagh', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sevigny', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khwaja', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Umbricht', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Fontoura', 'Affiliation': 'Product Development, F. Hoffmann-La Roche AG, Basel, Switzerland. paulo.fontoura@roche.com.'}]",Science translational medicine,['10.1126/scitranslmed.aat7838']
1027,31050143,"Efficacy and safety of an expanded dulaglutide dose range: A phase 2, placebo-controlled trial in patients with type 2 diabetes using metformin.","AIMS


Dulaglutide, a once weekly GLP-1 receptor agonist, is approved at two doses (1.5 and 0.75 mg) for treatment of type 2 diabetes (T2D). Two higher doses of dulaglutide (3.0 and 4.5 mg) were evaluated for safety and efficacy to determine whether these doses warrant further study for improved control of glucose and body weight.
MATERIALS AND METHODS


This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76). The primary objective was superiority of dulaglutide doses over placebo in reduction of HbA1c at 18 weeks. Secondary objectives included superiority of dulaglutide over placebo in change from baseline in body weight and fasting serum glucose (FSG) at 18 weeks. Investigational doses of dulaglutide were compared to the 1.5 mg dose as an exploratory objective.
RESULTS


HbA1c reduction at 18 weeks was significantly greater with dulaglutide vs placebo (placebo, -0.44% ± 0.10% [-4.8 ± 1.1 mmol/mol]; dulaglutide 1.5 mg, -1.23% ± 0.10% [-13.5 ± 1.1 mmol/mol]; dulaglutide 3.0 mg, -1.31% ± 0.10% [-14.3 ± 1.1 mmol/mol]; dulaglutide 4.5 mg, -1.40% ± 0.10% [-15.3 ± 1.1 mmol/mol]; P < 0.001, each dose), as were changes in body weight (placebo, -1.6 ± 0.39 kg; dulaglutide 1.5 mg, -2.8 ± 0.39 kg; dulaglutide 3.0 mg, -3.9 ± 0.39 kg; dulaglutide 4.5 mg, -4.1 ± 0.41 kg; P < 0.001, each dose). All three dulaglutide doses significantly reduced FSG from baseline (1.5 mg, -36.2 ± 4.7 mg/dL [-2.0 ± 0.3 mmol/L]; 3.0 mg, -34.5 ± 4.5 mg/dL [-1.9 ± 0.3 mmol/L]; 4.5 mg, -38.0 ± 4.7 mg/dL [-2.1 ± 0.3 mmol/L]) vs placebo (-12.4 ± 4.5 mg/dL [-0.7 ± 0.3 mmol/L]) (P < 0.001, all). Safety profiles of the higher doses were consistent with the established safety profile for dulaglutide. Gastrointestinal events were mostly mild to moderate, and was dose-related for nausea.
CONCLUSION


All three dulaglutide doses were superior to placebo in improving glycaemic control and reducing body weight in participants with T2D using metformin. The potential for doses of dulaglutide of 3.0 and 4.5 mg to provide additional glycaemic benefit and weight reduction with an acceptable safety profile, compared with the 1.5 mg dose, warrants further study in a phase 3 trial.",2019,All three dulaglutide doses were superior to placebo in improving glycaemic control and reducing body weight in participants with T2D using metformin.,"['patients with type 2 diabetes using', '318 patients with T2D using ≥1500\u2009mg', 'participants with T2D using']","['placebo', 'metformin', 'expanded dulaglutide dose range', 'dL', 'dulaglutide', 'dulaglutide 1.5 mg (n\u2009=\u200981), dulaglutide 3.0 mg (n\u2009=\u200979) or dulaglutide', 'metformin, to receive subcutaneous injection of placebo', 'dulaglutide over placebo', 'placebo (placebo']","['safety and efficacy', 'HbA1c reduction', 'glycaemic control and reducing body weight', 'Gastrointestinal events', 'body weight and fasting serum glucose (FSG', 'Efficacy and safety', 'nausea', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies (morphologic abnormality)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",318.0,0.169259,All three dulaglutide doses were superior to placebo in improving glycaemic control and reducing body weight in participants with T2D using metformin.,"[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Wynne', 'Affiliation': ""Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas.""}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Matyjaszek-Matuszek', 'Affiliation': 'Department of Endocrinology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Bartaskova', 'Affiliation': 'Diabetologická Ambulance, Prague, Czech Republic.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cox', 'Affiliation': 'Lilly Diabetes, Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Woodward', 'Affiliation': 'Lilly Diabetes, Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Ying G', 'Initials': 'YG', 'LastName': 'Li', 'Affiliation': 'Lilly Diabetes, Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Lai S', 'Initials': 'LS', 'LastName': 'Tham', 'Affiliation': 'Lilly Diabetes, Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Zvonko', 'Initials': 'Z', 'LastName': 'Milicevic', 'Affiliation': 'Lilly Diabetes, Eli Lilly and Company, Indianapolis, Indiana.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13764']
1028,31056081,Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial.,"BACKGROUND


Reduction of the pulse width has been reported to improve ECT outcomes with unilateral ECT (similar efficacy, fewer cognitive side effects), but has been minimally studied for bitemporal ECT. The only study comparing brief and ultrabrief pulse bitemporal ECT found reduced efficacy for bitemporal ultrabrief compared to bitemporal brief pulse stimulation. This randomised controlled trial (RCT) aimed to test if ultrabrief pulse bitemporal ECT results in fewer cognitive side effects than brief pulse bitemporal ECT, when given at doses adjusted with the aim of achieving comparable efficacy.
METHODS


Thirty-six participants were randomly assigned to receive ultrabrief (at 3 times seizure threshold) or brief (at 1.5 times seizure threshold) pulse bitemporal ECT given 3 times a week in a double-blind, controlled proof-of-concept trial. Blinded raters assessed mood and cognitive functioning over the ECT course.
RESULTS


Efficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course. The ultrabrief pulse group performed better on a test of visual memory assessed acutely after an ECT treatment.
CONCLUSIONS


This study suggests there may be a small cognitive advantage in giving bitemporal ECT with an ultrabrief pulse when dosage is increased to match the efficacy of brief pulse bitemporal ECT, but the study was underpowered to fully examine this issue.Clinical Trials Registration: www.clinicaltrials.gov, NCT00870805.",2020,Efficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course.,['Thirty-six participants'],"['ultrabrief pulse bitemporal ECT', 'ultrabrief pulse bitemporal electroconvulsive therapy', 'ultrabrief']","['mood and cognitive functioning', 'Efficacy and cognitive outcomes', 'cognitive side effects']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal (qualifier value)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",36.0,0.17552,Efficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course.,"[{'ForeName': 'Donel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Katalinic', 'Affiliation': 'St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Hadzi-Pavlovic', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ingram', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ingram', 'Affiliation': 'The Melbourne Clinic, Melbourne, VIC, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Simpson', 'Affiliation': 'St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'McGoldrick', 'Affiliation': 'Welsey Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Dowling', 'Affiliation': 'The Melbourne Clinic, Melbourne, VIC, Australia.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Loo', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}]",Psychological medicine,['10.1017/S0033291719000989']
1029,31452469,Cost-analysis of virtual reality training based on the Virtual Reality for Upper Extremity in Subacute stroke (VIRTUES) trial.,"OBJECTIVES


Stroke is a major cause of lasting disability worldwide. Virtual reality (VR) training has been introduced as a means of increasing the effectiveness of rehabilitation by providing large doses of task-related training with many repetitions and different modes of feedback. As VR is increasingly used in neurorehabilitation, cost considerations are important.
METHODS


A cost-analysis was conducted based on the Virtual Reality for Upper Extremity in Subacute stroke (VIRTUES) trial, a recent international randomized controlled observer-blind multicenter trial. Average therapist time required per therapy session may differ between VR and conventional training (CT), leading to potential cost savings due to a therapist being able to supervise more than one patient at a time. Exploratory cost analyses are presented to explore such assumptions.
RESULTS


Based on our calculations, VR incurs extra costs as compared with CT when the same amount of therapist contact is provided, as was the case in VIRTUES. However, the exploratory analyses demonstrated that these costs may be rapidly counterbalanced when time for therapist supervision can be reduced.
CONCLUSIONS


Extra costs for VR can be outweighed by reduced therapist time and decreasing VR system costs in the nearer future, and not least by increased patient motivation.",2019,"CONCLUSIONS


Extra costs for VR can be outweighed by reduced therapist time and decreasing VR system costs in the nearer future, and not least by increased patient motivation.",[],"['VR and conventional training (CT', 'virtual reality training', 'Virtual reality (VR) training']","['VR system costs', 'Average therapist time']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0252608,"CONCLUSIONS


Extra costs for VR can be outweighed by reduced therapist time and decreasing VR system costs in the nearer future, and not least by increased patient motivation.","[{'ForeName': 'M Kamrul', 'Initials': 'MK', 'LastName': 'Islam', 'Affiliation': 'NORCE Norwegian Research Centre AS, Nygårdsgaten 112, 5008 Bergen, Norway.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Brunner', 'Affiliation': 'Hammel Neurocenter, Department of Clinical Medicine, Aarhus University, 8450 Hammel, Denmark.'}]",International journal of technology assessment in health care,['10.1017/S026646231900059X']
1030,30907429,Cerebellar repetitive transcranial magnetic stimulation restores pharyngeal brain activity and swallowing behaviour after disruption by a cortical virtual lesion.,"KEY POINTS


Despite evidence that the human cerebellum has an important role in swallowing neurophysiology, the effects of cerebellar stimulation on swallowing in the disrupted brain have not been explored. In this study, for the first time, the application of cerebellar neurostimulation is characterized in a human model of disrupted swallowing (using a cortical virtual lesion). It is demonstrated that cerebellar stimulation can reverse the suppressed activity in the cortical swallowing system and restore swallowing function in a challenging behavioural task, suggesting the findings may have important therapeutic implications.
ABSTRACT


Repetitive transcranial magnetic stimulation (rTMS) can alter neuronal activity within the brain with therapeutic potential. Low frequency stimulation to the 'dominant' cortical swallowing projection induces a 'virtual-lesion' transiently suppressing cortical excitability and disrupting swallowing behaviour. Here, we compared the ability of ipsi-lesional, contra-lesional and sham cerebellar rTMS to reverse the effects of a 'virtual-lesion' in health. Two groups of healthy participants (n = 15/group) were intubated with pharyngeal catheters. Baseline pharyngeal motor evoked potentials (PMEPs) and swallowing performance (reaction task) were measured. Participants received 10 min of 1 Hz rTMS to the pharyngeal motor cortex which elicited the largest PMEPs to suppress cortical activity and disrupt swallowing behaviour. Over six visits, participants were randomized to receive 250 pulses of 10 Hz cerebellar rTMS to the ipsi-lesional side, contra-lesional side or sham while assessing PMEP amplitude or swallowing performance for an hour afterwards. Compared to sham, active cerebellar rTMS, whether administered ipsi-lesionally (P = 0.011) or contra-lesionally (P = 0.005), reversed the inhibitory effects of the cortical 'virtual-lesion' on PMEPs and swallowing accuracy (ipsi-lesional, P < 0.001, contra-lesional, P < 0.001). Cerebellar rTMS was able to reverse the disruptive effects of a 'virtual lesion'. These findings provide evidence for developing cerebellar rTMS into a treatment for post-stroke dysphagia.",2019,"Compared to sham, active cerebellar rTMS, whether administered ipsi-lesionally (P = 0.011) or contra-lesionally (P = 0.005), reversed the inhibitory effects of the cortical 'virtual-lesion' on PMEPs and swallowing accuracy (ipsi-lesional, P < 0.001, contra-lesional, P ",['Two groups of healthy participants (n\xa0=\xa015/group) were intubated with pharyngeal catheters'],"['10\xa0min of 1\xa0Hz rTMS', '250 pulses of 10\xa0Hz cerebellar rTMS to the ipsi-lesional side, contra-lesional side or sham while assessing PMEP amplitude or swallowing performance for an hour afterwards', 'Repetitive transcranial magnetic stimulation (rTMS', 'Cerebellar repetitive transcranial magnetic stimulation']","['cortical excitability and disrupting swallowing behaviour', ""inhibitory effects of the cortical 'virtual-lesion' on PMEPs and swallowing accuracy"", 'Baseline pharyngeal motor evoked potentials (PMEPs) and swallowing performance (reaction task']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0117061', 'cui_str': 'exopolysaccharide, Pseudomonas marginalis'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0117061', 'cui_str': 'exopolysaccharide, Pseudomonas marginalis'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",,0.0452782,"Compared to sham, active cerebellar rTMS, whether administered ipsi-lesionally (P = 0.011) or contra-lesionally (P = 0.005), reversed the inhibitory effects of the cortical 'virtual-lesion' on PMEPs and swallowing accuracy (ipsi-lesional, P < 0.001, contra-lesional, P ","[{'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Sasegbon', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Salford, UK.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Salford, UK.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Simons', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Salford, UK.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Michou', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Salford, UK.'}, {'ForeName': 'Dipesh H', 'Initials': 'DH', 'LastName': 'Vasant', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Salford, UK.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Magara', 'Affiliation': 'Division of Dysphagia Rehabilitation, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rothwell', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, University College London, London, UK.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Division of Dysphagia Rehabilitation, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Hamdy', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Salford, UK.'}]",The Journal of physiology,['10.1113/JP277545']
1031,31609774,Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial.,"OBJECTIVES


Previous trials suggest that vasopressin may improve outcomes in patients with vasodilatory shock. The aim of this study was to evaluate whether vasopressin could be superior to norepinephrine to improve outcomes in cancer patients with septic shock.
DESIGN


Single-center, randomized, double-blind clinical trial, and meta-analysis of randomized trials.
SETTING


ICU of a tertiary care hospital.
PATIENTS


Two-hundred fifty patients 18 years old or older with cancer and septic shock.
INTERVENTIONS


Patients were assigned to either vasopressin or norepinephrine as first-line vasopressor therapy. An updated meta-analysis was also conducted including randomized trials published until October 2018.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was all-cause mortality at 28 days after randomization. Prespecified secondary outcomes included 90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score 24 hours and 96 hours after randomization. We also measure the prevalence of adverse effects in 28 days. A total of 250 patients were randomized. The primary outcome was observed in 71 patients (56.8%) in the vasopressin group and 66 patients (52.8%) in the norepinephrine group (p = 0.52). There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
CONCLUSIONS


In cancer patients with septic shock, vasopressin as first-line vasopressor therapy was not superior to norepinephrine in reducing 28-day mortality rate.",2019,"There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
","['Cancer Patients', 'patients with vasodilatory shock', 'cancer patients with septic shock', 'Two-hundred fifty patients 18 years old or older with cancer and septic shock', '250 patients were randomized', 'ICU of a tertiary care hospital']","['vasopressin or norepinephrine', 'norepinephrine', 'Vasopressin Versus Norepinephrine', 'vasopressin']","['28-day mortality rate', '90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score', 'number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score', '90-day mortality', 'cause mortality', 'prevalence of adverse effects']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}]","[{'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",250.0,0.621102,"There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.
","[{'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'Zambolim', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Juliano Pinheiro', 'Initials': 'JP', 'LastName': 'de Almeida', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Section of Anaesthetics, Pain Medicine and Intensive Care, Faculty of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Clarice Hyesuk Lee', 'Initials': 'CHL', 'LastName': 'Park', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julia Tizue', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Stephanie Itala', 'Initials': 'SI', 'LastName': 'Rizk', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tais Felix', 'Initials': 'TF', 'LastName': 'Szeles', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nestor Cordeiro', 'Initials': 'NC', 'LastName': 'Dos Santos Neto', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto Kalil', 'Initials': 'RK', 'LastName': 'Filho', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Filomena Regina Barbosa Gomes', 'Initials': 'FRBG', 'LastName': 'Galas', 'Affiliation': 'Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000004023']
1032,30954691,Bolus therapy with 3% hypertonic saline or 0.9% saline in emergency department patients with suspected sepsis: A pilot randomised controlled trial.,"OBJECTIVE AND DESIGN


Hypertonic saline administered during fluid resuscitation may mitigate endothelial glycocalyx (EG) shedding and inflammation. The objective of this pilot randomised controlled trial was to measure the effect of hypertonic saline, compared to isotonic saline, on biomarkers of EG shedding and inflammation in emergency department patients with suspected sepsis.
METHODS


Patients received either 5 mL/kg of 3% saline (hypertonic group, n = 34) or 10 mL/kg of 0.9% saline (isotonic group, n = 31). Change in serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin were compared from baseline (T0) to after fluid (T1), 3 h (T3) and 12-24 h (T24) later, as was serum osmolality, using linear mixed effects models.
RESULTS


The hypertonic group had significantly increased mean serum osmolality compared to the isotonic group at T1 (P < .001) and T3 (P = .004). Minor differences were found in some biomarker outcomes, including a decreased fold-change in syndecan-1 at T1 (P = .012) and in interleukin-10 at T24 (P = .006) in the isotonic group, compared to the hypertonic group.
CONCLUSIONS


Although a single bolus of hypertonic saline increased serum osmolality, it did not reduce biomarkers of EG shedding or inflammation, compared to patients that received isotonic saline.
TRIAL REGISTRATION


ANZCTR.org.au, ACTRN12611001021965, Registered on 23rd September 2011.",2019,"Change in serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin were compared from baseline (T0) to after fluid (T1), 3 h (T3) and 12-24 h (T24) later, as was serum osmolality, using linear mixed effects models.
","['Patients received either', 'emergency department patients with suspected sepsis']","['5\u202fmL/kg of 3% saline (hypertonic group, n\u202f=\u202f34) or 10\u202fmL/kg of 0.9% saline (isotonic', 'hypertonic saline', 'hypertonic saline or 0.9% saline', 'isotonic saline']","['serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin', 'serum osmolality', 'mean serum osmolality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609943', 'cui_str': 'CD138 Antigens'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0202151', 'cui_str': 'Osmolality measurement, serum (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.483211,"Change in serum biomarker concentrations of syndecan-1, hyaluronan, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukin-6, -8, -10, interferon-γ, neutrophil gelatinase-associated lipocalin and resistin were compared from baseline (T0) to after fluid (T1), 3 h (T3) and 12-24 h (T24) later, as was serum osmolality, using linear mixed effects models.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smart', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Comparative Health Research Group, School of Veterinary Medicine, Murdoch University, Perth, Australia. Electronic address: Lisa.smart@research.uwa.edu.au.'}, {'ForeName': 'Stephen P J', 'Initials': 'SPJ', 'LastName': 'Macdonald', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Emergency Department, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Bosio', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatovich', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Emergency Department, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Neil', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Arendts', 'Affiliation': 'Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia; Emergency Medicine, University of Western Australia, Perth, Australia; Emergency Department, Fiona Stanley Hospital, Perth, Australia.'}]",Journal of critical care,['10.1016/j.jcrc.2019.03.009']
1033,31725332,Effects of alcohol intoxication goggles (fatal vision goggles) with a concurrent cognitive task on simulated driving performance.,"Objective:  Fatal vision goggles (FVGs) are image-distorting equipment used to simulate alcohol impairment in driver education programs. Unlike alcohol, which disrupts cognitive processes, FVG only induces visual impairment. Performing concurrent cognitive tasks while wearing FVG may reduce the wearer's attentional resources and provide a better simulation of alcohol intoxication. This study examined the impact of wearing FVG with/without administration of a concurrent cognitive task on simulated driving. Methods:  Twenty-one males (23 ± 3 y, mean ± SD) participated in this randomized, repeated-measures study involving two experimental trials. In each trial, participants completed a baseline drive then an experimental drive under one of two conditions: (1) FVG and (2) FVG with additional cognitive demand (FVG + CD). The driving test included 3 separate scenarios (Task 1, 2, 3) lasting ∼5min each. Lateral (standard deviation of lane position [SDLP]; number of lane crossings [LCs]) and longitudinal control parameters (average speed; standard deviation of speed [SDSP]; distance headway; minimum distance headway) were monitored in Tasks 1 and 2. Latency to two different stimuli (choice reaction time [CRT]) was examined in Task 3. Results:  In Task 1, SDLP and LC were unaffected by either condition. However, SDSP increased significantly from baseline with FVG, irrespective of cognitive demand. In Task 2, distance headway decreased significantly from baseline with FVG, but increased significantly with FVG + CD. Minimum distance headway was significantly decreased, while SDLP increased significantly and LC increased (although not statistically significant) in both conditions relative to baseline. In Task 3, a significant increase in CRT occurred with FVG + CD, but not with FVG alone. Conclusions:  Wearing FVG negatively impacted simulated driving performance. However, effects were isolated to specific performance outcomes and were dependent on complexity of the driving task. Addition of a secondary cognitive task exacerbates the effects of FVG on select driving outcomes (i.e. lane position, SDSP), influences the effect direction on other measures (i.e. distance headway), and has a detrimental effect on reaction time to stimuli embedded in the scenario, that is not observed with FVG alone. Future studies using FVG as a surrogate means to alcohol intoxication should consider these results, informing methodological decisions to reduce potential for confounding effects.",2019,"Minimum distance headway was significantly decreased, while SDLP increased significantly and LC increased (although not statistically significant) in both conditions relative to baseline.","['Methods:  Twenty-one males (23\u2009±\u20093\u2009y, mean\u2009±\u2009SD']","['Fatal vision goggles (FVGs', 'FVG and (2) FVG with additional cognitive demand (FVG\u2009+\u2009CD', 'alcohol intoxication goggles (fatal vision goggles', 'FVG']","['CRT', 'Minimum distance headway', 'SDSP', 'visual impairment', 'complexity of the driving task', 'lane crossings [LCs]) and longitudinal control parameters (average speed; standard deviation of speed [SDSP]; distance headway; minimum distance headway', 'distance headway']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0018020', 'cui_str': 'Goggles'}, {'cui': 'C0001969', 'cui_str': 'Drunkenness'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",21.0,0.0351429,"Minimum distance headway was significantly decreased, while SDLP increased significantly and LC increased (although not statistically significant) in both conditions relative to baseline.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Irwin', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Desbrow', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}]",Traffic injury prevention,['10.1080/15389588.2019.1669023']
1034,31729930,"The Lived Experiences, Perceptions, and Considerations of Patients After Operable Lung Cancer Concerning Nonparticipation in a Randomized Clinical Rehabilitation Trial.","The purpose of this study was to explore the lived experiences, perceptions, and considerations of individuals who declined participation in a randomized clinical trial involving exercise rehabilitation after surgery for lung cancer. An interpretive phenomenological approach was applied comprising interviews with 15 individuals who did not wish to participate in the trial. The findings shed light on a discrepancy between their freedom to act and make decisions and the limitations of having to act in a certain way. The participants found themselves in a gray area between a healthy life and a good life, as influenced by societal norms and taking responsibility for one's own health and rehabilitation. When including patients in rehabilitation after lung cancer, having insight into the underlying narrative on values and the good life, priorities in daily life, social context and the norms embedded in people's self-understanding is crucial.",2020,"The participants found themselves in a gray area between a healthy life and a good life, as influenced by societal norms and taking responsibility for one's own health and rehabilitation.","['after surgery for lung cancer', '15 individuals who did not wish to participate in the trial', 'patients in rehabilitation after lung cancer']",['exercise rehabilitation'],[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",[],,0.0405626,"The participants found themselves in a gray area between a healthy life and a good life, as influenced by societal norms and taking responsibility for one's own health and rehabilitation.","[{'ForeName': 'Mai Nanna', 'Initials': 'MN', 'LastName': 'Schoenau', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'The Social Home Care, Copenhagen, Denmark.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Ulvestad', 'Affiliation': 'Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Maja Schick', 'Initials': 'MS', 'LastName': 'Sommer', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Holst', 'Initials': 'JH', 'LastName': 'Pedersen', 'Affiliation': 'University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Missel', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Qualitative health research,['10.1177/1049732319886564']
1035,31678411,Bayesian cancer clinical trial designs with subgroup-specific decisions.,"Two illustrative applications are presented of Bayesian clinical trial designs that make adaptive subgroup-specific decisions based on elicited utilities of patient outcomes to quantify risk-benefit trade-offs. The first design is for a randomized trial to evaluate effects of nutritional prehabilitation on post-operative morbidity in esophageal cancer patients undergoing surgery. The second design is for a dose-finding trial of natural killer cells to treat advanced hematologic malignancies, with five time-to-event outcomes. Each design is based on a Bayesian hierarchical model that borrows strength between subgroups. Computer simulation is used to evaluate each design's properties, including comparison to a simpler design ignoring treatment-subgroup interactions. The simulations show that accounting prospectively for treatment-subgroup interactions yields designs with very desirable properties, is greatly superior to a simplified comparator design that ignores subgroups if treatment-subgroup interactions actually exist, and each design is robust to deviations from the assumed underlying model.",2020,"The simulations show that accounting prospectively for treatment-subgroup interactions yields designs with very desirable properties, is greatly superior to a simplified comparator design that ignores subgroups if treatment-subgroup interactions actually exist, and each design is robust to deviations from the assumed underlying model.",['esophageal cancer patients undergoing surgery'],['nutritional prehabilitation'],[],"[{'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],[],,0.0529792,"The simulations show that accounting prospectively for treatment-subgroup interactions yields designs with very desirable properties, is greatly superior to a simplified comparator design that ignores subgroups if treatment-subgroup interactions actually exist, and each design is robust to deviations from the assumed underlying model.","[{'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': 'Department of Biostatistics, M.D. Anderson Cancer Center, Houston, TX, United States of America. Electronic address: rex@mdanderson.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105860']
1036,31706052,Effect of bisphosphonate on the prevention of bone loss in patients with gastric cancer after gastrectomy: A randomized controlled trial.,"BACKGROUND


Bone loss is highly prevalent after gastrectomy in gastric cancer patients. Therefore, the efficacy of medical treatment should be evaluated in patients undergoing gastrectomy.
METHODS


We conducted an unblinded, randomized controlled trial of patients who underwent gastrectomy to treat gastric cancer. The intention-to-treat participants (n = 107) were randomly assigned to receive either alendronate at a weekly dose of 70 mg and daily elemental calcium (500 mg) with cholecalciferol (1000 IU) or daily elemental calcium (500 mg) with cholecalciferol (1000 IU) only. The primary endpoint was defined by the changes in bone mineral density of four measurement sites: the lumbar spine, femur neck, total hip, and trochanter. Changes in bone turnover markers, osteocalcin and collagen I carboxyterminal telopeptide were also observed.
RESULTS


At baseline, there were no differences between the two groups in bone mineral density. In the lumbar spine and trochanter, there were no significant percentage changes compared with the baseline in the alendronate group, but a significant decrease was noted in the control group (p < 0.001 for both lumbar spine and trochanter). In the femur neck and total hip, a larger decrease was observed compared with the baseline in the control group (p < 0.001 for both femur neck and total hip). Significant percentage increases in serum osteocalcin compared with baseline were noted in the control group (p for trend <0.001), but there was no change in the alendronate group (p for trend = 0.713). Collagen I carboxyterminal telopeptide significantly declined in the alendronate group over 12 months (p for trend <0.001).
CONCLUSIONS


Prevention and treatment with bisphosphonate effectively reduces bone loss by suppressing bone resorption in gastric cancer patients undergoing gastrectomy.",2020,"In the lumbar spine and trochanter, there were no significant percentage changes compared with the baseline in the alendronate group, but a significant decrease was noted in the control group (p < 0.001 for both lumbar spine and trochanter).","['patients who underwent gastrectomy to treat gastric cancer', 'patients with gastric cancer after gastrectomy', 'participants (n\u202f=\u202f107', 'patients undergoing gastrectomy', 'gastric cancer patients undergoing gastrectomy', 'gastric cancer patients']","['bisphosphonate', 'alendronate at a weekly dose of 70\u202fmg and daily elemental calcium', 'cholecalciferol', 'alendronate', 'daily elemental calcium']","['bone mineral density of four measurement sites: the lumbar spine, femur neck, total hip, and trochanter', 'bone loss', 'bone mineral density', 'serum osteocalcin', 'Collagen I carboxyterminal telopeptide', 'bone turnover markers, osteocalcin and collagen I carboxyterminal telopeptide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449687', 'cui_str': 'Measurement site'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}]",,0.116991,"In the lumbar spine and trochanter, there were no significant percentage changes compared with the baseline in the alendronate group, but a significant decrease was noted in the control group (p < 0.001 for both lumbar spine and trochanter).","[{'ForeName': 'Jeonghoon', 'Initials': 'J', 'LastName': 'Ha', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.""}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea. Electronic address: leejm68@catholic.ac.kr.""}, {'ForeName': 'Yejee', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Republic of Korea.'}, {'ForeName': 'Mee Kyoung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.""}, {'ForeName': 'Hyuk-Sang', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.""}, {'ForeName': 'Ki-Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.""}, {'ForeName': 'Hae Myung', 'Initials': 'HM', 'LastName': 'Jeon', 'Affiliation': ""Department of Surgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.""}, {'ForeName': 'Moo Il', 'Initials': 'MI', 'LastName': 'Kang', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.""}, {'ForeName': 'Ki-Hyun', 'Initials': 'KH', 'LastName': 'Baek', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea. Electronic address: drbkh@catholic.ac.kr.""}]",Bone,['10.1016/j.bone.2019.115138']
1037,27125223,In-home nighttime predictive low glucose suspend experience in children and adults with type 1 diabetes.,"Overnight predictive low glucose suspend (PLGS) reduces hypoglycemia across all ages; however, there are no reports on behavior or experience differences across age groups, especially in pediatrics. As run-in for a subsequent randomized clinical trial (RCT), 127 subjects (50% male) ages 4-45 yr utilized the experimental PLGS system nightly for 5-10 nights (PLGS active phase). We analyzed the number of blood glucose (BG) checks and boluses given per age group. During the subsequent 42 night RCT phase, we analyzed sensor use, skin reactions, errors, and reasons why the experimental system was not used. In 821 nights of active PLGS, subjects ages 4-6 yr (and their parents) tested BG levels 75% of nights compared with 65% of nights (7-10 yr), 53% of nights (11-14 yr), 33% of nights (15-25 yr), and 28% of nights (26-45 yr), respectively (p < 0.001). Likewise, youngest subjects (and parents) administered insulin boluses 56% of nights during active PLGS use compared with 48%, 33%, 20%, and 25%, respectively (p < 0.001). This was unrelated to study requirements. During the RCT phase, subjects 4-6 yr experienced more frequent and severe skin reactions (p = 0.02), while adult subjects (26-45 yr) wore individual sensors a median of 26 h longer than the youngest subjects (p < 0.001). Technical problems with the sensor (errors, miscalibrations, etc.), traveling, and BG levels >270 at bedtime (study requirement) were primary contributors to non-system use. Understanding the different use patterns and challenges in pediatrics and adolescence is needed to direct patient education to optimize use of PLGS and future artificial pancreas systems.",2017,"During the RCT phase, subjects 4-6 yr experienced more frequent and severe skin reactions (p = 0.02), while adult subjects (26-45 yr) wore individual sensors a median of 26 h longer than the youngest subjects (p < 0.001).","['children and adults with type 1 diabetes', '127 subjects (50% male) ages 4-45\u2009yr utilized the experimental PLGS system nightly for 5-10 nights (PLGS active phase']",['Overnight predictive low glucose suspend (PLGS'],"['frequent and severe skin reactions', 'BG levels', 'number of blood glucose (BG) checks']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1705537', 'cui_str': 'Suspended'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0436887,"During the RCT phase, subjects 4-6 yr experienced more frequent and severe skin reactions (p = 0.02), while adult subjects (26-45 yr) wore individual sensors a median of 26 h longer than the youngest subjects (p < 0.001).","[{'ForeName': 'Laurel H', 'Initials': 'LH', 'LastName': 'Messer', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Buckingham', 'Affiliation': 'Division of Endocrinology and Diabetes, Stanford School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Darrell M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Division of Endocrinology and Diabetes, Stanford School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': ""Division of Endocrinology and Metabolism, St Joseph's Health Care, London, ON, Canada.""}, {'ForeName': 'Trang T', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': 'Division of Endocrinology and Diabetes, Stanford School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Driscoll', 'Affiliation': ""Diabetes Clinical Trials Unit, St. Joseph's Health Care London, London, ON, Canada.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Clinton', 'Affiliation': 'Division of Endocrinology and Diabetes, Stanford School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.12395']
1038,31037505,The Effect on Nausea and Vomiting of Structured Education Given to Male Lung Cancer Patients Receiving Chemotherapy.,"The objective of this study was to investigate the effect on nausea and vomiting of structured education given to male lung cancer patients receiving chemotherapy. This quasi-experimental research study had pre- and post-tests control groups. The estimated sample size was at least 20 subjects per group. Data were collected in the chest diseases clinic and outpatient chemotherapy unit of a university hospital in Turkey. An education booklet and structured education were given 30 mins for each patient before chemotherapy. In post-test 1, nausea severity was significantly lower in the experimental group than in the control group (mean difference - 2.50, 95% CI - 1.46 to - 0.17, d = 0.82, p = 0.05). This was also the case in post-test 2 (mean difference - 2.10, 95% CI - 1.50 to - 0.21, d = 0.85, p = 0.01). According to this, the sizes of Cohen's d effect were large (0.82 and 0.85 for post-test 1 and post-test 2 respectively). However, vomiting frequency did not differ significantly between the experimental group and the control group in either post-test 1 or post-test 2 (p > 0.05). Structured education given by nurses had a positive effect on the severity of nausea. Nurses may be able to raise nausea management in cancer patients to a better level by education intervention.",2020,"However, vomiting frequency did not differ significantly between the experimental group and the control group in either post-test 1 or post-test 2 (p > 0.05).","['chest diseases clinic and outpatient chemotherapy unit of a university hospital in Turkey', 'Male Lung Cancer Patients', 'male lung cancer patients receiving chemotherapy', 'cancer patients']",['Chemotherapy'],"['nausea and vomiting', 'Nausea and Vomiting', 'vomiting frequency', 'severity of nausea', 'nausea severity']","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.0968816,"However, vomiting frequency did not differ significantly between the experimental group and the control group in either post-test 1 or post-test 2 (p > 0.05).","[{'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Ince', 'Affiliation': 'Sterilization Unit, Izzet Baysal Training and Research Hospital, Bolu Abant Izzet Baysal University, PO 14280, Golkoy/Bolu, Turkey. yasmingun@gmail.com.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Yildirim Usta', 'Affiliation': 'Department of Internal Medicine Nursing, Bolu Health School, Bolu Abant Izzet Baysal University, PO 14280, Golkoy/Bolu, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01531-4']
1039,31030594,Evaluation of efficacy and safety of oral terbinafine and itraconazole combination therapy in the management of dermatophytosis.,"BACKGROUND


There has been an alarming increase in recalcitrant dermatophytosis in recent years. The standard treatment guidelines no longer seem effective in achieving clearance and results in high failure rates.
OBJECTIVE


To evaluate the efficacy and safety of oral terbinafine and itraconazole combination therapy in the management of dermatophytosis.
METHODS


Clinically diagnosed and KOH positive patients of tinea corporis/cruris/faciei were randomly divided into three groups and given terbinafine 250 mg, itraconazole 200 mg and a combination of both once daily taken on the same day respectively for 3 weeks. Partial responders at the end of the therapy were given same treatment for additional 3 weeks. Clinical parameters namely itching, erythema, and scaling were evaluated at baseline, 3, 6, and 9 weeks. Adverse effects were noted at the end of therapy.
RESULTS


Maximum clinical and mycological cure was achieved in group III (receiving combination therapy) (90%) followed by group II (receiving itraconazole) (50%) and group I (receiving terbinafine) (35%). The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects.
CONCLUSIONS


The combination of systemic terbinafine and itraconazole therapy may be an effective and safe therapeutic strategy in the management of dermatophytosis.",2019,"The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects.
",['Clinically diagnosed and KOH positive patients of tinea corporis/cruris/faciei'],"['terbinafine and itraconazole therapy', 'terbinafine and itraconazole combination therapy', 'itraconazole', 'terbinafine 250\u2009mg, itraconazole', 'terbinafine and itraconazole', 'terbinafine']","['Clinical parameters namely itching, erythema, and scaling', 'Adverse effects', 'mycological cure', 'efficacy and safety']","[{'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040252', 'cui_str': 'Tinea corporis (disorder)'}]","[{'cui': 'C0956383', 'cui_str': 'Terbinafine, (Z)-isomer'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1596471', 'cui_str': 'terbinafine 250 MG [Lamisil]'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205467', 'cui_str': 'Mycologic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0174065,"The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects.
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'a Department of Dermatology , Government Medical College and Hospital , Chandigarh , India.'}, {'ForeName': 'Mala', 'Initials': 'M', 'LastName': 'Bhalla', 'Affiliation': 'a Department of Dermatology , Government Medical College and Hospital , Chandigarh , India.'}, {'ForeName': 'Gurvinder P', 'Initials': 'GP', 'LastName': 'Thami', 'Affiliation': 'a Department of Dermatology , Government Medical College and Hospital , Chandigarh , India.'}, {'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Chander', 'Affiliation': 'b Department of Microbiology , Government Medical College and Hospital , Chandigarh , India.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1612835']
1040,31034030,Euthermia in Stable Preterm Babies: 'Cocooning' for Warmth! - A Randomized Controlled Trial.,"Very preterm babies, after their initial need for rigorous supports, remain in intensive care units for maintaining euthermia. We compared proportion of 'hypothermia OR hyperthermia episodes(HHE)'; physiological instability events; and weight gain in stable preterm babies between 29 and 32 weeks nursed in Cocoon warmer (CW) vs. servo-controlled Radiant warmer(RW) in the intervals between kangaroo mother care. Sixty-six babies were randomized to CW and 59 to RW; number of temperature recordings over 24 h in CW were 1417 and 1271 in RW. HHE were comparable in RW (4.64%) and CW (5.15%); RR 1.1(0.79-1.55), p = 0.6. The combined incidence of physiological instability events was less in CW than RW [(RR 0.49 (0.25-0.97), p = 0.06]. Mean weight gain was similar, being 13.4 ± 6.1 g/day in CW and 12.8 ± 4.9 g/day in RW (p = 0.55). CW was comparable to RW in thermoregulation of hospitalized stable preterm babies.",2020,"The combined incidence of physiological instability events was less in CW than RW [(RR 0.49 (0.25-0.97), p = 0.06].","['Very preterm babies', 'stable preterm babies between 29 and 32\u2009weeks nursed in Cocoon warmer (CW) vs. servo-controlled Radiant warmer(RW) in the intervals between kangaroo mother care', 'Sixty-six babies', 'Stable Preterm Babies']",['CW'],"['Mean weight gain', 'physiological instability events', 'HHE']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0599994', 'cui_str': 'Overprotected (finding)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",66.0,0.0715381,"The combined incidence of physiological instability events was less in CW than RW [(RR 0.49 (0.25-0.97), p = 0.06].","[{'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Vijayan', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, Kerala.'}, {'ForeName': 'Femitha', 'Initials': 'F', 'LastName': 'Pournami', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, Kerala.'}, {'ForeName': 'Jyothi', 'Initials': 'J', 'LastName': 'Prabhakar', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, Kerala.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Neonatology, Kerala Institute of Medical Sciences, Trivandrum 695029, Kerala.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz025']
1041,31029616,Myocardial Blood Flow and Coronary Flow Reserve During 3 Years Following Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent Implantation: The VANISH Trial.,"OBJECTIVES


The randomized clinical VANISH (Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: A Randomized [ 15 O]H 2 O PET/CT Study) trial was conducted to assess quantitative myocardial blood flow (MBF) during resting, hyperemia, and cold pressor testing (CPT) with positron emission tomographic perfusion imaging after the implantation of a bioresorbable everolimus-eluting scaffold compared with a drug-eluting stent.
BACKGROUND


Long-term resorption of the bioresorbable everolimus-eluting scaffold reinstates normal vessel geometry, allowing natural regeneration of the newly formed endothelium with revival of vasomotor function.
METHODS


Sixty patients (18 to 65 years of age) with single-vessel disease and type A or B1 lesions were randomized in a 1-to-1 fashion. Approximately 1 month, 1 year, and 3 years after device implantation, patients underwent [ 15 O]H 2 O cardiac positron emission tomography. The primary endpoint was the interaction of device type and evolution over time of hyperemic MBF, coronary flow reserve, or CPT reserve. At 3-year follow-up, control invasive coronary angiography with optical coherence tomography was performed.
RESULTS


Fifty-nine (98%), 56 (93%), and 51 (85%) patients successfully completed 1-month, 1-year, and 3-year follow-up positron emission tomography, respectively, and no culprit vessel events were registered during follow-up time. The primary study endpoint (i.e., interaction between device type and time) was nonsignificant for hyperemic MBF, CPT reserve, and coronary flow reserve (p > 0.05 for all). In all patients, hyperemic MBF decreased from 1 to 3 years (p = 0.02), while coronary flow reserve was lower at 3-year follow-up compared with 1-month and 1-year follow-up (p = 0.03 for both). After 3 years, percentage area stenosis measured with optical coherence tomography was higher within the bioresorbable everolimus-eluting scaffold compared with the drug-eluting stent (p = 0.03).
CONCLUSIONS


The hypothesized beneficial effects of scaffold resorption did not translate to improved MBF during maximal hyperemia or endothelium-dependent vasodilation by CPT.",2019,"After 3 years, percentage area stenosis measured with optical coherence tomography was higher within the bioresorbable everolimus-eluting scaffold compared with the drug-eluting stent (p = 0.03).
",['Sixty patients (18 to 65 years of age) with single-vessel disease and type A or B1 lesions'],"['Vascular Reparative Therapy', 'control invasive coronary angiography with optical coherence tomography', 'Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent Implantation']","['hyperemic MBF, CPT reserve, and coronary flow reserve', 'Vasomotor Function and Myocardial Perfusion', 'percentage area stenosis measured with optical coherence tomography', 'culprit vessel events', 'interaction of device type and evolution over time of hyperemic MBF, coronary flow reserve, or CPT reserve', 'coronary flow reserve', 'Myocardial Blood Flow and Coronary Flow Reserve', 'hyperemic MBF', 'quantitative myocardial blood flow (MBF) during resting, hyperemia, and cold pressor testing (CPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0856737', 'cui_str': 'Single vessel disease'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0232365', 'cui_str': 'Vasomotor function (observable entity)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}]",,0.107485,"After 3 years, percentage area stenosis measured with optical coherence tomography was higher within the bioresorbable everolimus-eluting scaffold compared with the drug-eluting stent (p = 0.03).
","[{'ForeName': 'Wijnand J', 'Initials': 'WJ', 'LastName': 'Stuijfzand', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Schumacher', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Roel S', 'Initials': 'RS', 'LastName': 'Driessen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Lammertsma', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Bakker', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Mischa T', 'Initials': 'MT', 'LastName': 'Rijnierse', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter G', 'Initials': 'PG', 'LastName': 'Raijmakers', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands. Electronic address: p.knaapen@vumc.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.03.004']
1042,30601823,"HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: An adaptive multi-arm, multi-stage cluster randomised trial.","BACKGROUND


Conventional HIV testing services have been less comprehensive in reaching men than in reaching women globally, but HIV self-testing (HIVST) appears to be an acceptable alternative. Measurement of linkage to post-test services following HIVST remains the biggest challenge, yet is the biggest driver of cost-effectiveness. We investigated the impact of HIVST alone or with additional interventions on the uptake of testing and linkage to care or prevention among male partners of antenatal care clinic attendees in a novel adaptive trial.
METHODS AND FINDINGS


An adaptive multi-arm, 2-stage cluster randomised trial was conducted between 8 August 2016 and 30 June 2017, with antenatal care clinic (ANC) days (i.e., clusters of women attending on a single day) as the unit of randomisation. Recruitment was from Ndirande, Bangwe, and Zingwangwa primary health clinics in urban Blantyre, Malawi. Women attending an ANC for the first time for their current pregnancy (regardless of trimester), 18 years and older, with a primary male partner not known to be on ART were enrolled in the trial after giving consent. Randomisation was to either the standard of care (SOC; with a clinic invitation letter to the male partner) or 1 of 5 intervention arms: the first arm provided women with 2 HIVST kits for their partners; the second and third arms provided 2 HIVST kits along with a conditional fixed financial incentive of $3 or $10; the fourth arm provided 2 HIVST kits and a 10% chance of receiving $30 in a lottery; and the fifth arm provided 2 HIVST kits and a phone call reminder for the women's partners. The primary outcome was the proportion of male partners who were reported to have tested for HIV and linked into care or prevention within 28 days, with referral for antiretroviral therapy (ART) or circumcision accordingly. Women were interviewed at 28 days about partner testing and adverse events. Cluster-level summaries compared each intervention versus SOC using eligible women as the denominator (intention-to-treat). Risk ratios were adjusted for male partner testing history and recruitment clinic. A total of 2,349/3,137 (74.9%) women participated (71 ANC days), with a mean age of 24.8 years (SD: 5.4). The majority (2,201/2,233; 98.6%) of women were married, 254/2,107 (12.3%) were unable to read and write, and 1,505/2,247 (67.0%) were not employed. The mean age for male partners was 29.6 years (SD: 7.5), only 88/2,200 (4.0%) were unemployed, and 966/2,210 (43.7%) had never tested for HIV before. Women in the SOC arm reported that 17.4% (71/408) of their partners tested for HIV, whereas a much higher proportion of partners were reported to have tested for HIV in all intervention arms (87.0%-95.4%, p < 0.001 in all 5 intervention arms). As compared with those who tested in the SOC arm (geometric mean 13.0%), higher proportions of partners met the primary endpoint in the HIVST + $3 (geometric mean 40.9%, adjusted risk ratio [aRR] 3.01 [95% CI 1.63-5.57], p < 0.001), HIVST + $10 (51.7%, aRR 3.72 [95% CI 1.85-7.48], p < 0.001), and phone reminder (22.3%, aRR 1.58 [95% CI 1.07-2.33], p = 0.021) arms. In contrast, there was no significant increase in partners meeting the primary endpoint in the HIVST alone (geometric mean 17.5%, aRR 1.45 [95% CI 0.99-2.13], p = 0.130) or lottery (18.6%, aRR 1.43 [95% CI 0.96-2.13], p = 0.211) arms. The lottery arm was dropped at interim analysis. Overall, 46 male partners were confirmed to be HIV positive, 42 (91.3%) of whom initiated ART within 28 days; 222 tested HIV negative and were not already circumcised, of whom 135 (60.8%) were circumcised as part of the trial. No serious adverse events were reported. Costs per male partner who attended the clinic with a confirmed HIV test result were $23.73 and $28.08 for the HIVST + $3 and HIVST + $10 arms, respectively. Notable limitations of the trial included the relatively small number of clusters randomised to each arm, proxy reporting of the male partner testing outcome, and being unable to evaluate retention in care.
CONCLUSIONS


In this study, the odds of men's linkage to care or prevention increased substantially using conditional fixed financial incentives plus partner-delivered HIVST; combinations were potentially affordable.
TRIAL REGISTRATION


ISRCTN 18421340.",2019,"Overall, 46 male partners were confirmed to be HIV positive, 42 (91.3%) of whom initiated ART within 28 days; 222 tested HIV negative and were not already circumcised, of whom 135 (60.8%) were circumcised as part of the trial.","['A total of 2,349/3,137 (74.9%) women participated (71 ANC days), with a mean age of 24.8 years (SD: 5.4', 'Women attending an ANC for the first time for their current pregnancy (regardless of trimester), 18 years and older, with a primary male partner not known to be on ART were enrolled in the trial after giving consent', 'male partners who were reported to have tested for HIV and linked into care or prevention within 28 days, with referral for antiretroviral therapy (ART) or circumcision accordingly', 'male partners of antenatal care clinic attendees in Malawi', 'male partners of antenatal care clinic attendees in a novel adaptive trial', 'mean age for male partners was 29.6 years (SD: 7.5), only 88/2,200 (4.0%) were unemployed, and 966/2,210 (43.7%) had never tested for HIV before', '8 August 2016 and 30 June 2017, with antenatal care clinic (ANC) days (i.e., clusters of women attending on a single day) as the unit of randomisation', '46 male partners']","['HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention', 'HIVST alone or with additional interventions', 'standard of care (SOC; with a clinic invitation letter to the male partner) or 1 of 5 intervention arms: the first arm provided women with 2 HIVST kits for their partners; the second and third arms provided 2 HIVST kits along with a conditional fixed financial incentive of $3 or $10; the fourth arm provided 2 HIVST kits and a 10% chance of receiving $30 in a lottery; and the fifth arm provided 2 HIVST kits and a phone call reminder', 'aRR']","['Risk ratios', 'adjusted risk ratio [aRR', 'HIVST ', 'HIVST alone (geometric mean 17.5%, aRR', 'serious adverse events']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",46.0,0.299659,"Overall, 46 male partners were confirmed to be HIV positive, 42 (91.3%) of whom initiated ART within 28 days; 222 tested HIV negative and were not already circumcised, of whom 135 (60.8%) were circumcised as part of the trial.","[{'ForeName': 'Augustine T', 'Initials': 'AT', 'LastName': 'Choko', 'Affiliation': 'TB/HIV Group, Malawi-Liverpool-Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'TB/HIV Group, Malawi-Liverpool-Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Lepine', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Cheryl C', 'Initials': 'CC', 'LastName': 'Johnson', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Sakala', 'Affiliation': 'TB/HIV Group, Malawi-Liverpool-Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Thokozani', 'Initials': 'T', 'LastName': 'Kalua', 'Affiliation': 'Department of HIV/AIDS, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kumwenda', 'Affiliation': 'TB/HIV Group, Malawi-Liverpool-Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1002719']
1043,30943578,Systemic therapy in the management of localized and locally advanced renal cell carcinoma: Current state and future perspectives.,"Systemic therapy strategies in the setting of localized and locally advanced renal cell carcinoma have continued to evolve in two directions: (i) as adjuvant therapy (to reduce the risk of recurrence or progression in high-risk localized groups); or (ii) as neoadjuvant therapy as a strategy to render primary renal tumors amenable to planned surgical resection in settings where radical resection or nephron-sparing surgery was not thought to be safe or feasible. In the realm of adjuvant therapy, the results of adjuvant therapy phase III randomized clinical trials have been mixed and contradictory; nevertheless, the findings of the landmark Sunitinib Treatment of Renal Adjuvant Cancer study have led to approval of sunitinib as an adjuvant agent in the USA. In the realm of neoadjuvant therapy, presurgical tumor reduction has been shown in a number of phase II studies utilizing targeted molecular agents and in a recently published small randomized double-blind placebo-controlled study, and an expanding body of literature suggests benefit in select patients. Thus, large randomized clinical trial data are not present to support this approach, and guidelines for use of presurgical therapy have not been promulgated. The advent of immunomodulation through checkpoint inhibition represents an exciting horizon for adjuvant and neoadjuvant strategies. The present article reviews the current status and future prospects of adjuvant and neoadjuvant therapy in localized and locally advanced renal cell carcinoma.",2019,"In the realm of neoadjuvant therapy, presurgical tumor reduction has been shown in a number of phase II studies utilizing targeted molecular agents and in a recently published small randomized double-blind placebo-controlled study, and an expanding body of literature suggests benefit in select patients.",['localized and locally advanced renal cell carcinoma'],"['Systemic therapy', 'radical resection or nephron-sparing surgery']",[],"[{'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0027713', 'cui_str': 'Nephrons'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],,0.109447,"In the realm of neoadjuvant therapy, presurgical tumor reduction has been shown in a number of phase II studies utilizing targeted molecular agents and in a recently published small randomized double-blind placebo-controlled study, and an expanding body of literature suggests benefit in select patients.","[{'ForeName': 'Sean W', 'Initials': 'SW', 'LastName': 'Berquist', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Kendrick', 'Initials': 'K', 'LastName': 'Yim', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Ryan', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Sunil H', 'Initials': 'SH', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Eldefrawy', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Brittney H', 'Initials': 'BH', 'LastName': 'Cotta', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Bradshaw', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Meagher', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Bindayi', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Rana R', 'Initials': 'RR', 'LastName': 'McKay', 'Affiliation': 'Division of Medical Oncology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Autorino', 'Affiliation': 'Division of Urology, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Department of Urology, Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Ithaar H', 'Initials': 'IH', 'LastName': 'Derweesh', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13943']
1044,30997142,A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): protocol for a randomised controlled feasibility study.,"Background


Osteoarthritis is a highly prevalent condition in older adults, that causes many sufferers to require a hip or knee replacement in order to improve their quality of life and reduce pain. Individuals waiting for hip or knee replacements are often highly sedentary; thus, it is pertinent to assess whether reducing their sedentariness prior to surgery may aid in improving post-operative outcomes.
Methods/design


The study will be a randomised controlled feasibility trial design, with 2:1 randomisation into an intervention and usual care group respectively. A target of 45 patients aged 60 years or older waiting for elective hip and knee replacements will be recruited from Russells Hall Hospital, Dudley, UK, approximately 8-10 weeks before surgery. The intervention, informed by Self-Determination Theory (SDT), will be composed of multiple behaviour change techniques, namely, motivational interviewing, feedback on current objectively measured sedentary behaviour and activity, goal-setting, environmental modification, self-monitoring, and social support. Assessments will occur at baseline, 1 week pre-surgery, and 6 weeks post-surgery. The primary outcome will be the feasibility of intervention delivery and of the trial procedures, assessed quantitatively based on rates of recruitment, retention, measures-completion, and intervention fidelity assessment, and with mixed-methods assessment of acceptability, practicality, adaption, satisfaction, and safety. Exploratory outcomes will include physical function, cardiometabolic biomarkers, measurement of SDT constructs, and both objective and subjective measurement of physical activity and sedentariness. The study will last up to 18 weeks per participant. No formal between-group comparisons are planned, but the variance in within-group changes and differences between groups in outcome measures will be explored and reported with 95% confidence intervals.
Discussion


This is the first study assessing the feasibility of an intervention to reduce sedentary behaviour in older adults with mobility limitations, and the first to assess whether such a reduction could work in a prehabilitative context prior to surgery. The results of this study will help inform the design of a definitive randomised controlled trial.
Trial registration


This trial is registered on Clinicaltrials.gov. Registration number: NCT03740412. Date of registration: 13/11/2018.",2019,"This is the first study assessing the feasibility of an intervention to reduce sedentary behaviour in older adults with mobility limitations, and the first to assess whether such a reduction could work in a prehabilitative context prior to surgery.","['older adults with mobility limitations', 'Individuals waiting for hip or knee replacements', 'older adults undergoing orthopaedic surgery (INTEREST', '45 patients aged 60\u2009years\xa0or older waiting for elective hip and knee replacements will be recruited from Russells Hall Hospital, Dudley, UK, approximately 8-10\u2009weeks before surgery', 'older adults']",[],"['sedentary behaviour', 'physical function, cardiometabolic biomarkers, measurement of SDT constructs, and both objective and subjective measurement\xa0of\xa0physical activity and sedentariness', 'feasibility of intervention delivery and of the trial procedures, assessed quantitatively based on rates of recruitment, retention, measures-completion, and intervention fidelity assessment, and with mixed-methods assessment of acceptability, practicality, adaption, satisfaction, and safety', 'quality of life and reduce pain']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for (contextual qualifier) (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C2356088', 'cui_str': 'Halls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",[],"[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.140406,"This is the first study assessing the feasibility of an intervention to reduce sedentary behaviour in older adults with mobility limitations, and the first to assess whether such a reduction could work in a prehabilitative context prior to surgery.","[{'ForeName': 'Justin Avery', 'Initials': 'JA', 'LastName': 'Aunger', 'Affiliation': '1School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, B15 2TT UK.'}, {'ForeName': 'Colin James', 'Initials': 'CJ', 'LastName': 'Greaves', 'Affiliation': '1School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, B15 2TT UK.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Davis', 'Affiliation': '2Royal Orthopaedic Hospital NHS Foundation Trust, Bristol Road South, Northfield, Birmingham, B31 2AP UK.'}, {'ForeName': 'Carolyn Anne', 'Initials': 'CA', 'LastName': 'Greig', 'Affiliation': '1School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, B15 2TT UK.'}]",Pilot and feasibility studies,['10.1186/s40814-019-0437-2']
1045,31835196,Self-distancing as a path to help-seeking for people with depression.,"OBJECTIVE


Three studies explored whether self-distancing, a method where the self is treated as an other, can impact help-seeking among those with depression. Self-distancing was expected to reduce the negative biases associated with depression by minimizing self-relevance through taking the perspective of an objective other. We hypothesized that when thinking about a past experience of help-seeking, a selfdistancing prompt would cause increased help-seeking intentions and more favorable help-seeking outcome expectations. The influence of selfdistancing on the self-stigma of help-seeking was also explored.
METHODS


Participants were randomly assigned to write (Studies 1 and 3) or watch a video (Study 2) where they were prompted to think about helpseeking from their own perspective or an objective other's perspective. Studies 2 and 3 were pre-registered on the Open Science Framework.
RESULTS


In Study 1, self-distancing increased help-seeking intentions but did not influence help-seeking expectations or self-stigma. The a priori hypotheses were not supported in Study 2 or 3. However, exploratory analyses of Study 3 revealed an interaction between condition and level of depressive symptomatology indicating that the distancing condition weakened the relationship between higher levels of depressive symptomatology and lower help-seeking intentions, and between higher levels of depressive symptomatology and higher self-stigma. Additionally, analyses of written responses indicated participants in the distancing condition were significantly less likely to write responses void of positive content.
CONCLUSION


Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.",2020,"Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.","['people with depression', 'Participants']",[],"['depressive symptomatology and lower help-seeking intentions', 'depressive symptomatology and higher self-stigma', 'help-seeking intentions']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",,0.0296119,"Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Hollar', 'Affiliation': 'Claremont Graduate University, United States. Electronic address: sara.hollar@cgu.edu.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Claremont Graduate University, United States.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.112700']
1046,30862667,A Human TRPA1-Specific Pain Model.,"The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances. However, TRPA1 species differences are substantial and limit translational research. TRPA1 agonists tested previously in humans also have other targets. Therefore, the sensation generated by isolated TRPA1 activation in humans is unknown. The availability of 2-chloro -N- (4-(4-methoxyphenyl)thiazol-2-yl) -N- (3-methoxypropyl)-acetamide (JT010), a potent and specific TRPA1 agonist, allowed us to explore this issue. To corroborate the specificity of JT010, it was investigated whether the TRPA1 antagonist (1E,3E)-1-(4-fluorophenyl)-2-methyl-1-penten-3-one oxime (A-967079) abolishes JT010-elicited pain. Sixteen healthy volunteers of both sexes rated pain due to intraepidermal injections of different concentrations and combinations of the substances. The study design was a double-blind crossover study. All subjects received all types of injections, including a placebo without substances. Injections of the TRPA1 agonist dose-dependently caused pain with a half-maximal effective concentration of 0.31 μm Coinjection of A-967079 dose-dependently reduced and at a high concentration abolished JT010-induced pain. Quantification of JT010 by HPLC showed that a substantial part is adsorbed when in contact with polypropylene surfaces, but that this was overcome by handling in glass vials and injection using glass syringes. Isolated TRPA1 activation in humans causes pain. Thus, intradermal JT010 injection can serve as a tool to validate new TRPA1 antagonists concerning target engagement. More importantly, TRPA1-specific tools allow quantification of the TRPA1-dependent component in physiology and pathophysiology. SIGNIFICANCE STATEMENT  This study showed that activation of the ion channel transient receptor potential ankyrin 1 (TRPA1) alone indeed suffices to elicit pain in humans, independent of other receptors previously found to be involved in pain generation. The newly established TRPA1-specific pain model allows different applications. First, it can be tested whether diseases are associated with compromised or exaggerated TRPA1-dependent painful sensations in the skin. Second, it can be investigated whether a new, possibly systemically applied drug directed against TRPA1 engages its target in humans. Further, the general possibility of quantitative inhibition of TRPA1 allows identification of the TRPA1-dependent disease component, given that the substance reaches its target. This contributes to a better understanding of pathophysiology, can lay the basis for new therapeutic approaches, and can bridge the gap between preclinical research and clinical trials.",2019,The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances.,['Sixteen healthy volunteers of both sexes rated pain'],"['2-chloro -N- (4-(4-methoxyphenyl)thiazol-2-yl) -N', 'placebo without substances', '3-methoxypropyl)-acetamide (JT010', 'TRPA1 antagonist (1E,3E)-1-(4-fluorophenyl)-2-methyl-1-penten-3-one oxime']",['pain'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0050423', 'cui_str': 'acetamide'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0030020', 'cui_str': 'Hydroxyimino Compounds'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",16.0,0.0439185,The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Heber', 'Affiliation': 'Institutes of Physiology, stefan.heber@meduniwien.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gold-Binder', 'Affiliation': 'Institutes of Physiology.'}, {'ForeName': 'Cosmin I', 'Initials': 'CI', 'LastName': 'Ciotu', 'Affiliation': 'Institutes of Physiology.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Witek', 'Affiliation': 'Pharmacology, Center for Physiology and Pharmacology, and.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Ninidze', 'Affiliation': 'Division of Special Anesthesia and Pain Medicine, Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kress', 'Affiliation': 'Division of Special Anesthesia and Pain Medicine, Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michael J M', 'Initials': 'MJM', 'LastName': 'Fischer', 'Affiliation': 'Institutes of Physiology.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3048-18.2019']
1047,30843602,Cycling with blood flow restriction improves performance and muscle K +  regulation and alters the effect of anti-oxidant infusion in humans.,"KEY POINTS


Training with blood flow restriction (BFR) is a well-recognized strategy for promoting muscle hypertrophy and strength. However, its potential to enhance muscle function during sustained, intense exercise remains largely unexplored. In the present study, we report that interval training with BFR augments improvements in performance and reduces net K +  release from contracting muscles during high-intensity exercise in active men. A better K +  regulation after BFR-training is associated with an elevated blood flow to exercising muscles and altered muscle anti-oxidant function, as indicated by a higher reduced to oxidized glutathione (GSH:GSSG) ratio, compared to control, as well as an increased thigh net K +  release during intense exercise with concomitant anti-oxidant infusion. Training with BFR also invoked fibre type-specific adaptations in the abundance of Na +  ,K +  -ATPase isoforms (α 1  , β 1  , phospholemman/FXYD1). Thus, BFR-training enhances performance and K +  regulation during intense exercise, which may be a result of adaptations in anti-oxidant function, blood flow and Na +  ,K +  -ATPase-isoform abundance at the fibre-type level.
ABSTRACT


We examined whether blood flow restriction (BFR) augments training-induced improvements in K +  regulation and performance during intense exercise in men, and also whether these adaptations are associated with an altered muscle anti-oxidant function, blood flow and/or with fibre type-dependent changes in Na +  ,K +  -ATPase-isoform abundance. Ten recreationally-active men (25 ± 4 years, 49.7 ± 5.3 mL kg -1   min -1  ) performed 6 weeks of interval cycling, where one leg trained without BFR (control; CON-leg) and the other trained with BFR (BFR-leg, pressure: ∼180 mmHg). Before and after training, femoral arterial and venous K +  concentrations and artery blood flow were measured during single-leg knee-extensor exercise at 25% (Ex1) and 90% of thigh incremental peak power (Ex2) with i.v. infusion of N-acetylcysteine (NAC) or placebo (saline) and a resting muscle biopsy was collected. After training, performance increased more in BFR-leg (23%) than in CON-leg (12%, P < 0.05), whereas K +  release during Ex2 was attenuated only from BFR-leg (P < 0.05). The muscle GSH:GSSG ratio at rest and blood flow during exercise was higher in BFR-leg than in CON-leg after training (P < 0.05). After training, NAC increased resting muscle GSH concentration and thigh net K +  release during Ex2 only in BFR-leg (P < 0.05), whereas the abundance of Na +  ,K +  -ATPase-isoform α 1  in type II (51%), β 1  in type I (33%), and FXYD1 in type I (108%) and type II (60%) fibres was higher in BFR-leg than in CON-leg (P < 0.05). Thus, training with BFR elicited greater improvements in performance and reduced thigh K +  release during intense exercise, which were associated with adaptations in muscle anti-oxidant function, blood flow and Na +  ,K +  -ATPase-isoform abundance at the fibre-type level.",2019,"Training with BFR also invoked fibre type-specific adaptations in the abundance of Na +  ,K +  -ATPase isoforms (α 1  , β 1  , phospholemman/FXYD1).","['humans', 'Ten recreationally-active men (25\xa0±\xa04\xa0years, 49.7\xa0±\xa05.3\xa0mL']","['blood flow restriction (BFR', 'blood flow restriction', 'leg trained without BFR (control; CON-leg) and the other trained with BFR (BFR-leg, pressure', 'N-acetylcysteine (NAC) or placebo (saline']","['performance and reduced thigh K +  release', 'muscle anti-oxidant function, blood flow and Na +  ,K +  -ATPase-isoform abundance', 'muscle GSH:GSSG ratio at rest and blood flow', 'resting muscle GSH concentration and thigh net K +  release', 'femoral arterial and venous K +  concentrations and artery blood flow', 'abundance of Na +  ,K +  -ATPase-isoform α 1', 'BFR-leg']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708663', 'cui_str': '5.3'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0001473', 'cui_str': 'ATPases'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.0239916,"Training with BFR also invoked fibre type-specific adaptations in the abundance of Na +  ,K +  -ATPase isoforms (α 1  , β 1  , phospholemman/FXYD1).","[{'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Christiansen', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper H', 'Initials': 'KH', 'LastName': 'Eibye', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Villads', 'Initials': 'V', 'LastName': 'Rasmussen', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans M', 'Initials': 'HM', 'LastName': 'Voldbye', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Thomassen', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nyberg', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas G P', 'Initials': 'TGP', 'LastName': 'Gunnarsson', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Skovgaard', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads S', 'Initials': 'MS', 'LastName': 'Lindskrog', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hostrup', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of physiology,['10.1113/JP277657']
1048,31722404,Analgesic Effects of Directed Repetitive Transcranial Magnetic Stimulation in Acute Neuropathic Pain After Spinal Cord Injury.,"OBJECTIVES


Central neuropathic pain (CNP) often appears following spinal cord injury (SCI), but current treatments are not always successful. In this study, we evaluated the analgesic effects of repetitive transcranial magnetic stimulation (rTMS) applied over the hand area of the motor cortex in patients with acute CNP after SCI.
METHODS


A total of 48 patients with complete or incomplete SCI and acute CNP participated in this study and were randomized to receive either rTMS (10 Hz, 1,500 stimuli; N = 24) or a sham intervention (N = 24) for three weeks. The numeric rating scale (NRS) and Short-Form McGill Pain Questionnaire-2 (Chinese Edition; SF-MPQ-2-CN) were analyzed to assess the degree of pain. Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) were collected to explore expression influenced by rTMS. Motor-evoked potential (MEP) latency and maximal amplitude were measured to determine neurophysiological changes. The assessments were carried out at baseline (T0), three days (T1), one week (T2), two weeks (T3), and three weeks (T4) after onset of treatment.
RESULTS


The analysis showed significant treatment-time interactions for the quality and intensity of pain, as measured by NRS (P < 0.001, η2 = 0.441) and SF-MPQ-2 (P < 0.001, η2 = 0.590). Compared with the sham group, the NRS and SF-MPQ2-CN scores were significantly lower on the third day (P < 0.001, Cohen's d = 1.135; P = 0.006, Cohen's d = 0.616) and after one week (P < 0.001, Cohen's d = 0.846; P = 0.012, Cohen's d = 0.557) of treatment. In addition, the serum levels of BDNF and NGF were significantly higher in the treated group after three weeks (P = 0.015, Cohen's d = 0.539; P = 0.009, Cohen's d = 0.580), and the MEP amplitude increased by 109.59% (P = 0.033, Cohen's d = 0.464).
CONCLUSIONS


These findings indicate that 10 Hz rTMS over the hand area of the motor cortex could alleviate acute CNP in the early phase of SCI and could enhance MEP parameters and modulate BDNF and NGF secretion.",2020,"Compared with the sham group, the NRS and SF-MPQ2-CN scores were significantly lower on the third day (P < 0.001, Cohen's d = 1.135; P = 0.006, Cohen's d = 0.616) and after one week (P < 0.001, Cohen's d = 0.846; P = 0.012, Cohen's d = 0.557) of treatment.",['patients with acute CNP after SCI.\nMETHODS\n\n\nA total of 48 patients with complete or incomplete SCI and acute CNP participated in this study'],"['Directed Repetitive Transcranial Magnetic Stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['degree of pain', 'Acute Neuropathic Pain', 'serum levels of BDNF and NGF', 'SF-MPQ-2', 'MEP parameters and modulate BDNF and NGF secretion', 'Motor-evoked potential (MEP) latency and maximal amplitude', 'NRS and SF-MPQ2-CN scores', 'numeric rating scale (NRS) and Short-Form McGill Pain Questionnaire-2 (Chinese Edition; SF-MPQ-2-CN', 'quality and intensity of pain', 'MEP amplitude', 'Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",1500.0,0.188542,"Compared with the sham group, the NRS and SF-MPQ2-CN scores were significantly lower on the third day (P < 0.001, Cohen's d = 1.135; P = 0.006, Cohen's d = 0.616) and after one week (P < 0.001, Cohen's d = 0.846; P = 0.012, Cohen's d = 0.557) of treatment.","[{'ForeName': 'Chen-Guang', 'Initials': 'CG', 'LastName': 'Zhao', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Ju', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Sun', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Mou', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz290']
1049,31725021,"A Prospective, Randomized, Double-Blinded Study of the Effect of Intravenous Ondansetron on the Effective Dose in 50% of Subjects of Prophylactic Phenylephrine Infusions for Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Delivery.","BACKGROUND


Ondansetron has been shown to reduce the incidence of hypotension and vasopressor requirement during spinal anesthesia for obstetric and nonobstetric surgery. However, the magnitude of this effect has not been fully quantified. In this parallel-group, randomized, double-blinded study, we determined the effective dose in 50% of subjects (ED50) of a prophylactic phenylephrine infusion for preventing hypotension in patients who received a single dose of intravenous ondansetron 4 mg or saline control before combined spinal-epidural anesthesia for elective cesarean delivery. ED50 values obtained were compared to estimate the effect of ondansetron versus placebo on vasopressor requirement.
METHODS


Sixty parturients were randomly assigned to receive ondansetron (group O) or saline control (group C) 10 minutes before positioning for induction of spinal anesthesia. A prophylactic phenylephrine infusion was used to prevent hypotension. The first patient in each group received a phenylephrine infusion at the rate of 0.5 µg/kg/min. The infusion rate for each subsequent patient was varied with increments or decrements of 0.05 µg/kg/min based on the response of the previous patient, and the effective dose of the phenylephrine infusion for preventing hypotension in 50% of patients (ED50) was calculated for each group and compared using up-down sequential analysis. Probit regression was applied as a backup and sensitivity analysis was used to compare ED50 values for phenylephrine between groups by comparing calculated relative mean potency.
RESULTS


The ED50 (mean [95% confidence interval (CI)]) of the rate of phenylephrine infusion was lower in group O (0.24 µg/kg/min [0.10-0.38 µg/kg/min]) compared with group C (0.32 µg/kg/min [0.14-0.47 µg/kg/min]) (P < .001). The total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery was lower in group O (316.5 ± 25.9 µg) than in group C (387.7 ± 14.7 µg, P = .02). The estimate of relative median potency for phenylephrine for group O versus group C was 0.74 (95% CI, 0.37-0.95).
CONCLUSIONS


Under the conditions of this study, intravenous ondansetron 4 mg reduced the ED50 of a prophylactic phenylephrine infusion by approximately 26% in patients undergoing cesarean delivery under combined spinal-epidural anesthesia.",2020,"The total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery was lower in group O (316.5 ± 25.9 µg) than in group C (387.7 ± 14.7 µg, P = .02).","['before combined spinal-epidural anesthesia for elective cesarean delivery', '50% of Subjects of Prophylactic Phenylephrine Infusions for Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Delivery', 'patients undergoing cesarean delivery under combined spinal-epidural anesthesia', 'Sixty parturients']","['prophylactic phenylephrine infusion', 'ondansetron', 'phenylephrine infusion', 'ondansetron 4 mg or saline control', 'Intravenous Ondansetron', 'phenylephrine', 'placebo', 'saline control', 'Ondansetron']","['rate of phenylephrine infusion', 'total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery', 'hypotension', 'infusion rate', 'relative median potency']","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1123367', 'cui_str': 'Ondansetron 4 MG'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.512375,"The total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery was lower in group O (316.5 ± 25.9 µg) than in group C (387.7 ± 14.7 µg, P = .02).","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Changna', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Yinfa', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Obstetrics, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Obstetrics, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anesthesiology, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Xinzhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004534']
1050,30761523,"Neprilysin inhibition for pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled, proof-of-concept trial.","BACKGROUND AND PURPOSE


Pulmonary arterial hypertension (PAH) is an incurable, incapacitating disorder resulting from increased pulmonary vascular resistance, pulmonary arterial remodelling, and right ventricular failure. In preclinical models, the combination of a PDE5 inhibitor (PDE5i) with a neprilysin inhibitor augments natriuretic peptide bioactivity, promotes cGMP signalling, and reverses the structural and haemodynamic deficits that characterize PAH. Herein, we conducted a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of repurposing the neprilysin inhibitor, racecadotril, in PAH.
EXPERIMENTAL APPROACH


Twenty-one PAH patients stable on PDE5i therapy were recruited. Acute haemodynamic and biochemical changes following a single dose of racecadotril or matching placebo were determined; this was followed by a 14-day safety and efficacy evaluation. The primary endpoint in both steps was the maximum change in circulating atrial natriuretic peptide (ANP) concentration (Δ max  ), with secondary outcomes including pulmonary and systemic haemodynamics plus mechanistic biomarkers.
KEY RESULTS


Acute administration of racecadotril (100 mg) resulted in a 79% increase in the plasma ANP concentration and a 106% increase in plasma cGMP levels, with a concomitant 14% fall in pulmonary vascular resistance. Racecadotril (100 mg; t.i.d.) treatment for 14 days resulted in a 19% rise in plasma ANP concentration. Neither acute nor chronic administration of racecadotril resulted in a significant drop in mean arterial BP or any serious adverse effects.
CONCLUSIONS AND IMPLICATIONS


This Phase IIa evaluation provides proof-of-principle evidence that neprilysin inhibitors may have therapeutic utility in PAH and warrants a larger scale prospective trial.",2019,"Neither acute nor chronic administration of racecadotril resulted in a significant drop in mean arterial BP or any serious adverse effects.
","['Twenty-one PAH patients stable on PDE5i therapy were recruited', 'pulmonary arterial hypertension']","['placebo', 'racecadotril or matching placebo', 'Racecadotril', 'Neprilysin inhibition', 'racecadotril', 'PDE5 inhibitor (PDE5i']","['plasma cGMP levels', 'plasma ANP concentration', 'mean arterial BP or any serious adverse effects', 'pulmonary vascular resistance', 'efficacy and safety', 'maximum change in circulating atrial natriuretic peptide (ANP) concentration (Δ max  ), with secondary outcomes including pulmonary and systemic haemodynamics plus mechanistic biomarkers']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0050461', 'cui_str': 'racecadotril'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027481', 'cui_str': 'Atriopeptins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",21.0,0.648475,"Neither acute nor chronic administration of racecadotril resulted in a significant drop in mean arterial BP or any serious adverse effects.
","[{'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Hobbs', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Amie J', 'Initials': 'AJ', 'LastName': 'Moyes', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Reshma S', 'Initials': 'RS', 'LastName': 'Baliga', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Dipa', 'Initials': 'D', 'LastName': 'Ghedia', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ochiel', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Sylvestre', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maclagan', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Quartly', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Reecha', 'Initials': 'R', 'LastName': 'Sofat', 'Affiliation': 'Centre for Clinical Pharmacology, Rayne Institute, London, UK.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Smit', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Schreiber', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gerry J', 'Initials': 'GJ', 'LastName': 'Coghlan', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'MacAllister', 'Affiliation': 'Dorset County Hospital NHS Foundation Trust, Dorset, UK.'}]",British journal of pharmacology,['10.1111/bph.14621']
1051,31025924,"Primary efficacy of netakimab, a novel interleukin-17 inhibitor, in the treatment of active ankylosing spondylitis in adults.","OBJECTIVES


Netakimab (NTK) is a humanised monoclonal antibody targeting interleukin-17A, previously investigated in a phase 1 trial in healthy volunteers. Here, we report the results of a phase 2 trial, conducted to assess safety and pharmacokinetics (PK), to establish a therapeutic dose of NTK in a target population of patients with active ankylosing spondylitis (AS).
METHODS


89 patients with active AS, despite non-steroidal anti-inflammatory (NSAID) drug treatment, were randomised to receive 40, 80 or 120 mg of subcutaneous NTK or placebo at weeks 0, 1, 2 and q2wk thereafter until week 12. The primary endpoint was to achieve a proportion of patients with ≥20% improvement in Assessment of Spondyloarthritis.
RESULTS


Rates of ASAS20 response at week 16 for NTK with 95%CI for difference in ASAS20 rates NTK vs. placebo were 72.73% [1.69%;58.05%], 81.82% [12.36%;65.56%], 90.91% [23.71%;72.39%] at doses of 40, 80 and 120 mg. The response rate in the placebo arm was 42.86%. The pre-specified margin of clinically non-meaningful difference was 10%. Superiority to placebo was confirmed for doses 80 and 120 mg. The most frequent adverse events (AEs) were lymphocytosis, neutropenia, and asymptomatic bacteriuria. No dose-dependent toxicity or serious adverse events (SAEs) were observed. The most effective dose with the fastest response onset and favourable safety profile was 120 mg.
CONCLUSIONS


The data obtained demonstrate the efficacy and favourable safety profile of NTK in active AS. Clinical development of NTK will be continued in a phase 3 trial aimed to evaluate the efficacy of 1-year treatment with NTK 120 mg in patients with AS.",2020,No dose-dependent toxicity or serious adverse events (SAEs) were observed.,"['healthy volunteers', 'patients with AS', '89 patients with active AS, despite non-steroidal anti-inflammatory (NSAID) drug treatment', 'patients with active ankylosing spondylitis (AS', 'active ankylosing spondylitis in adults']","['NTK', 'subcutaneous NTK or placebo', 'placebo', 'netakimab, a novel interleukin-17 inhibitor']","['ASAS20 response', 'lymphocytosis, neutropenia, and asymptomatic bacteriuria', 'safety and pharmacokinetics (PK', 'response rate', 'toxicity or serious adverse events (SAEs', 'proportion of patients with ≥20% improvement in Assessment of Spondyloarthritis']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0253479', 'cui_str': 'megakaryocyte-associated tyrosine kinase, mouse'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0024282', 'cui_str': 'Lymphocytosis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}]",89.0,0.576528,No dose-dependent toxicity or serious adverse events (SAEs) were observed.,"[{'ForeName': 'Shandor', 'Initials': 'S', 'LastName': 'Erdes', 'Affiliation': 'Nasonova Research Institute of Rheumatology, Moscow, Russia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Nasonov', 'Affiliation': 'Nasonova Research Institute of Rheumatology, Moscow, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kunder', 'Affiliation': 'Academy for Postgraduate Education, Minsk, Belarus.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Pristrom', 'Affiliation': 'Academy for Postgraduate Education, Minsk, Belarus.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Soroka', 'Affiliation': 'Belarus State Medical University, Minsk, Belarus.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Shesternya', 'Affiliation': 'Krasnoyarsk State Medical University, Krasnoyarsk, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Dubinina', 'Affiliation': 'Nasonova Research Institute of Rheumatology, Moscow, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Smakotina', 'Affiliation': 'Regional Clinical Hospital, Kemerovo, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Raskina', 'Affiliation': 'Kemerovo State Medical University, Kemerovo, Russia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Krechikova', 'Affiliation': 'Regional Clinical Hospital, Smolensk, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Povarova', 'Affiliation': 'Road Clinical Hospital, Saratov, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plaksina', 'Affiliation': 'Clinical Hospital, Nizhniy Novgorod, Russia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Gordeev', 'Affiliation': 'City Clinical Hospital No. 15, Moscow, Russia.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Mazurov', 'Affiliation': 'North-Western State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Reshetko', 'Affiliation': 'Regional Clinical Hospital, Saratov, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zonova', 'Affiliation': 'Municipal Clinical Inpatient Facility No. 1, Novosibirsk, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eremeeva', 'Affiliation': 'JSC BIOCAD, St. Petersburg, Russia. eremeevaav@biocad.ru.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Chernyaeva', 'Affiliation': 'JSC BIOCAD, St. Petersburg, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Makulova', 'Affiliation': 'Institute for Medical Research, St. Petersburg, Russia.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Ivanov', 'Affiliation': 'JSC BIOCAD, St. Petersburg, Russia.'}]",Clinical and experimental rheumatology,[]
1052,31412825,Women's income and risk of intimate partner violence: secondary findings from the MAISHA cluster randomised trial in North-Western Tanzania.,"BACKGROUND


Intimate partner violence (IPV) is pervasive throughout the world, with profound consequences for women's health. While women's 'economic empowerment' is touted as a potential means to reduce IPV, evidence is mixed as to the role of different economic factors in determining women's risk. This paper explores associations and potential pathways between women's income and experience of IPV, in Mwanza city, Tanzania.
METHODS


We use data from married/cohabiting women (N = 740) enrolled in the MAISHA study, a cluster randomised trial of an IPV prevention intervention. Women were interviewed at baseline and 29-months later. We use logistic regression to model cross-sectional (baseline) and longitudinal associations between: a woman's monthly income (quartiles) and her past year risk of physical IPV, sexual IPV and economic abuse; and a woman's relative financial contribution to the household (same/less than partner; more than partner) and past year physical IPV and sexual IPV.
RESULTS


At baseline, 96% of respondents reported earning an income and 28% contributed more financially to the household than their partner did. Higher income was associated with lower past-year physical IPV risk at baseline and longitudinally, and lower sexual IPV at baseline only. No clear associations were seen between income and economic abuse. Higher relative financial contribution was associated with increased physical IPV and sexual IPV among all women at baseline, though only among control women longitudinally. Higher income was associated with several potential pathways to reduced IPV, including reduced household hardship, fewer arguments over the partner's inability to provide for the family, improved relationship dynamics, and increased relationship dissolution. Those contributing more than their partner tended to come from more disadvantaged households, argue more over their partner's inability to provide, and have worse relationship dynamics.
CONCLUSIONS


While women's income was protective against IPV, women who contributed more financially than their partners had greater IPV risk. Poverty and tensions over men's inability to provide emerge as potentially important drivers of this association. Interventions to empower women should not only broaden women's access to economic resources and opportunities, but also work with women and men to address men's livelihoods, male gender roles and masculinity norms.
TRIAL REGISTRATION


ClinicalTrials.gov #NCT02592252 , registered retrospectively (13/08/2015).",2019,"Higher income was associated with several potential pathways to reduced IPV, including reduced household hardship, fewer arguments over the partner's inability to provide for the family, improved relationship dynamics, and increased relationship dissolution.","[""Women's income and risk of intimate partner violence"", ""woman's monthly income (quartiles) and her past year risk of physical IPV, sexual IPV and economic abuse; and a woman's relative financial contribution to the household (same/less than partner; more than partner) and past year physical IPV and sexual IPV"", 'Intimate partner violence (IPV', 'married/cohabiting women (N\xa0=\u2009740) enrolled in the MAISHA study', ""women's income and experience of IPV, in Mwanza city, Tanzania""]",['IPV prevention intervention'],"['lower past-year physical IPV risk', 'sexual IPV', 'physical IPV and sexual IPV', 'IPV risk']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1138437', 'cui_str': 'Financial Contributions'}, {'cui': 'C0445247', 'cui_str': 'Same (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",740.0,0.0695079,"Higher income was associated with several potential pathways to reduced IPV, including reduced household hardship, fewer arguments over the partner's inability to provide for the family, improved relationship dynamics, and increased relationship dissolution.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Abramsky', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK. Tanya.abramsky@lshtm.ac.uk.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Lees', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Stöckl', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Kapinga', 'Affiliation': 'Mwanza Intervention Trials Unit, PO Box 11936, Mwanza, Tanzania.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Mshana', 'Affiliation': 'Mwanza Intervention Trials Unit, PO Box 11936, Mwanza, Tanzania.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, PO Box 11936, Mwanza, Tanzania.'}]",BMC public health,['10.1186/s12889-019-7454-1']
1053,31608431,Postoperative quality and safety using Efficacy Safety Score (ESS) and a wireless patient monitoring system at the ward: A randomised controlled study.,"BACKGROUND


Postoperative pain, side-effects and time to mobilisation are indicators for the quality of postoperative recovery. The aim of this randomised controlled study was to investigate if efficacy safety score (ESS) combined with a wireless patient monitoring system would improve these clinical outcomes for patients at a general surgical ward.
METHODS


The trial included 195 patients randomised to a standard care group (SC-Group) or intervention group (INT-Group) receiving continuous wireless monitoring of vital signs combined with ESS during the first 24 postoperative hours. The primary outcome was time to mobilisation. Secondary outcomes were average pain, doses of postoperative opioids, unscheduled interventions, side-effects, patient satisfaction and length of hospital stay (LOS).
RESULTS


Mean time to postoperative mobilisation was 10.1 hours for patients in the INT-Group compared to 14.2 hours in the SC-Group; this corresponds to an adjusted hazard ratio of 1.54 (95% confidence interval 1.04-2.28). INT-Group patients received a higher dose of oral morphine equivalents; 26 mg vs 15 mg, P < .001; reported lower intensity of pain on a 0-10 scale; 2.1 vs 3.3, P < .001; and had higher patient satisfaction on a 5-point scale; 4.9 vs 4.3, P < .001. The LOS was similar between the groups; 71 hours in INT-Group vs 77 hours in SC-Group, P = .58. No serious side-effects were registered in INT-Group, whereas two were registered in SC-Group.
CONCLUSIONS


Introducing ESS as a decision tool combined with a wireless monitoring system resulted in less pain, increased satisfaction and more rapid mobilisation for patients in this study.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT03438578.",2020,"The length of hospital stay was similar between the groups; 71 hours in INT-Group vs 77 hours in SC-Group, P=0.58.","['195 patients randomised to a', 'patients at a general surgical ward']","['oral morphine', 'standard care group (SC-Group) or intervention group (INT-Group) receiving continuous wireless monitoring of vital signs combined with ESS', 'wireless patient monitoring system']","['Postoperative quality and safety using Efficacy Safety Score (ESS', 'average pain, doses of postoperative opioids, unscheduled interventions, side-effects, patient satisfaction and length of hospital stay', 'Mean time to postoperative mobilisation', 'length of hospital stay', 'Efficacy Safety Score (ESS', 'time to mobilisation', 'serious side-effects', 'intensity of pain', 'pain, increased satisfaction']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0030695', 'cui_str': 'Patient Monitoring'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",195.0,0.259256,"The length of hospital stay was similar between the groups; 71 hours in INT-Group vs 77 hours in SC-Group, P=0.58.","[{'ForeName': 'Erlend Johan', 'Initials': 'EJ', 'LastName': 'Skraastad', 'Affiliation': 'Clinic of Anaesthesia and Intensive care, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Petter Christian', 'Initials': 'PC', 'LastName': 'Borchgrevink', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Tom Ivar L', 'Initials': 'TIL', 'LastName': 'Nilsen', 'Affiliation': 'Clinic of Anaesthesia and Intensive care, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Raeder', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Oslo University Hospital, Oslo, Norway.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13492']
1054,31001740,The Health Promoting Mindfulness or Qigong Educational Programs for Beneficial Lifestyle Changes of Cancer Survivors.,"This study used heart rate variability (HRV) to monitor levels of cancer-related fatigue (CRF) and quality of life (QOL) of cancer survivors subjected to program measures at different psychosomatic or functional levels. A longitudinal study was conducted at a cancer center in Taiwan. Fifty-two cancer survivals were randomly assigned to either the mindfulness group (n = 25) or the Qigong group (n = 27). Both groups received a 12-week mindfulness and Qigong programs, respectively. Improvements in CRF, QOL, and HRV after a 12-week program and at the 3-month follow-up point. For the long-term effects in both mindfulness and Qigong groups, CRF showed a significant downward trend (p < 0.05), but a significant upward trend was observed in HRV (p < 0.001). Mindfulness and Qigong exhibited different effectiveness in individuals, indicating that the mental and physical aspects of health are equally essential and should be addressed in a complementary combination. These findings are worthy of being shared with cancer survivors to benefit their physical and mental well-being. We suggest that healthcare professionals incorporate mindfulness and Qigong in cancer survivors' daily life as means to encourage lifestyle changes for improving their health.",2020,"For the long-term effects in both mindfulness and Qigong groups, CRF showed a significant downward trend (p < 0.05), but a significant upward trend was observed in HRV (p < 0.001).","['Fifty-two cancer survivals', 'cancer center in Taiwan', 'Cancer Survivors']",['Health Promoting Mindfulness or Qigong Educational Programs'],"['CRF, QOL, and HRV', 'HRV', 'heart rate variability (HRV) to monitor levels of cancer-related fatigue (CRF) and quality of life (QOL']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}]",52.0,0.0201319,"For the long-term effects in both mindfulness and Qigong groups, CRF showed a significant downward trend (p < 0.05), but a significant upward trend was observed in HRV (p < 0.001).","[{'ForeName': 'Tse-Chou', 'Initials': 'TC', 'LastName': 'Cheng', 'Affiliation': 'Department of Urology, Chi Mei Medical Center, Liouying, 201, Taikang, Taikang Vil., Liouying Dist., Tainan City, 73657, Taiwan.'}, {'ForeName': 'Yi-Hua', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Administration, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County, 35053, Taiwan.'}, {'ForeName': 'Chun-Lin', 'Initials': 'CL', 'LastName': 'Mar', 'Affiliation': 'College of Educational Sciences, Yulin Normal University, 1303 Educational E. Road, Yulin City, Guangxi, 537000, China.'}, {'ForeName': 'Wen-Tsung', 'Initials': 'WT', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chi Mei Medical Center, Liouying, 201, Taikang, Taikang Vil., Liouying Dist., Tainan City, 73657, Taiwan.'}, {'ForeName': 'Yuan-Ping', 'Initials': 'YP', 'LastName': 'Chang', 'Affiliation': 'Nursing Department, Fooyin University, 151 Jinxue Rd., Daliao Dist., Kaohsiung City, 83102, Taiwan. fyucyp@gmail.com.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01522-5']
1055,30968431,Deep neuromuscular blockade for endolaryngeal procedures: A multicenter randomized study.,"OBJECTIVES/HYPOTHESIS


The aim of the present study was to compare the surgical condition between deep neuromuscular blockade (NMB) and moderate NMB.
STUDY DESIGN


Multicenter, randomized, parallel intervention trial.
METHODS


One hundred two patients underwent microscopic endolaryngeal surgery at four university hospitals. The patients were randomized into moderate NMB (train-of-four 1-2) (M group) or deep NMB (post-tetanic count 1-2) (D group) with moderate or high doses of rocuronium, respectively. Surgical rating conditions (SRCs) were evaluated during the surgery. Sugammadex was given to the M group at 2 mg/kg and the D group at 4 mg/kg. Perioperative clinical signs and conditions were recorded until discharge from the postanesthesia care unit.
RESULTS


Clinically acceptable SRC was observed in 49 patients (100%) in the D group and 43 patients (89.6%) in the M group (P = .027). The frequency of notable vocal fold movement in the M group was significantly higher than the D group (70.8% vs. 32.7%). The patients in the M group required more additional doses of rocuronium (47.9%) than the D group (20.4%) to maintain full relaxation (P = .005). The median time (interquartile range) from administration of sugammadex to train-of-four ratio 0.9 in the D group was shorter than the M group (120 [109-180 minutes] vs. 180 minutes [120-240 minutes], P = .034).
CONCLUSIONS


Deep NMB with high doses of rocuronium combined with 4 mg/kg of sugammadex for reversal during endolaryngeal surgery provided better SRC and anesthetic conditions than moderate NMB of rocuronium with 2 mg/kg of sugammadex.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:437-441, 2020.",2020,The frequency of notable vocal fold movement in the M group was significantly higher than the D group (70.8% vs. 32.7%).,['One hundred two patients underwent microscopic endolaryngeal surgery at four university hospitals'],"['moderate NMB (train-of-four 1-2) (M group) or deep NMB', 'deep neuromuscular blockade (NMB', 'Sugammadex', 'rocuronium']","['Surgical rating conditions (SRCs', 'frequency of notable vocal fold movement', 'median time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",102.0,0.215599,The frequency of notable vocal fold movement in the M group was significantly higher than the D group (70.8% vs. 32.7%).,"[{'ForeName': 'Prok', 'Initials': 'P', 'LastName': 'Laosuwan', 'Affiliation': 'Department of Anesthesiology, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Phuriphong', 'Initials': 'P', 'LastName': 'Songarj', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Worawut', 'Initials': 'W', 'LastName': 'Lapisatepun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Settapong', 'Initials': 'S', 'LastName': 'Boonsri', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Oraluxna', 'Initials': 'O', 'LastName': 'Rodanant', 'Affiliation': 'Department of Anesthesiology, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Wirat', 'Initials': 'W', 'LastName': 'Wasinwong', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Wimonrat', 'Initials': 'W', 'LastName': 'Sriraj', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Jittiya', 'Initials': 'J', 'LastName': 'Watcharotayangul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Mingkwan', 'Initials': 'M', 'LastName': 'Wongyingsinn', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",The Laryngoscope,['10.1002/lary.27956']
1056,30990088,Parent-Teen Group versus Dyadic Treatment for Adolescent ADHD: What Works for Whom?,"The goal of this study was to evaluate the comparative efficacy of 2 clinic-based psychosocial treatment modalities for adolescent attention deficit/hyperactivity disorder (ADHD) and identify characteristics that facilitate patient-modality matching. Culturally diverse adolescents with ADHD ( N =  123) were randomized to 1 of 2 versions of a parent-teen psychosocial treatment for ADHD (Supporting Teens' Autonomy Daily [STAND]): (a) group parent and adolescent skills training or (b) dyadic skills training blended with motivational interviewing. Participants were assessed at baseline, posttreatment, and 6-month follow-up on ADHD symptom severity and functional treatment targets. Differences in therapy process and cost were documented. Modality differences in outcome were examined using linear mixed and general linear models. Each modality successfully engaged the proposed therapy processes. Dyadic and group STAND produced equivalent overall outcomes. However, the dyadic modality demonstrated superior efficacy when parents had elevated ADHD or depression symptoms or high conflict with the teen. Families with lower parent education level and higher parental depression showed lower overall attendance; married parents were more likely to attend dyadic STAND (vs. group). Naturalistic stimulant medication did not influence treatment outcome. At less than one third of the cost of dyadic treatment, group models may be an economical option for treating parents and adolescents with ADHD. Screening adolescents with ADHD for parental psychopathology and parent-teen conflict may allow clinics to match higher risk patients to more personalized approaches that can enhance efficacy.",2020,Families with lower parent education level and higher parental depression showed lower overall attendance; married parents were more likely to attend dyadic STAND (vs. group).,"['N =\xa0123', 'Culturally diverse adolescents with ADHD', 'parents and adolescents with ADHD', 'Screening adolescents with ADHD', 'adolescent attention deficit/hyperactivity disorder (ADHD', 'Adolescent ADHD']","['2 clinic-based psychosocial treatment modalities', ""parent-teen psychosocial treatment for ADHD (Supporting Teens' Autonomy Daily [STAND"", 'adolescent skills training or (b) dyadic skills training blended with motivational interviewing']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]",[],123.0,0.0355367,Families with lower parent education level and higher parental depression showed lower overall attendance; married parents were more likely to attend dyadic STAND (vs. group).,"[{'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Florida International University.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Center for Children and Families, Florida International University.'}, {'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Coxe', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Health Policy and Management, Florida International University.'}, {'ForeName': 'Kisbel', 'Initials': 'K', 'LastName': 'Espinal', 'Affiliation': 'Center for Children and Families, Florida International University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1585257']
1057,30976196,Implementation of the Family Nurse Partnership programme in England: experiences of key health professionals explored through trial parallel process evaluation.,"Background


The Family Nurse Partnership (FNP) programme was introduced to support young first-time mothers. A randomised trial found FNP added little short-term benefit compared to usual care. The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context. The aim of the focus groups was to investigate views of key health professionals towards the integration and delivery of FNP programme in England.
Methods


Focus groups were conducted separately with Family Nurses, Health Visitors and Midwives at trial sites during 2011-2012. Transcripts from audio-recordings were analysed thematically.
Results


A total of 122 professionals participated in one of 19 focus groups. Family Nurses were confident in the effectiveness of FNP, although they experienced practical difficulties meeting programme fidelity targets and considered that programme goals did not sufficiently reflect client or community priorities. Health Visitors and Midwives regarded FNP as well-resourced and beneficial to clients, describing their own services as undervalued and struggling. They wished to work closely with Family Nurses, but felt excluded from doing so by practical barriers and programme protection.
Conclusion


FNP was described as well-resourced and delivered by highly motivated and well supported Family Nurses. FNP eligibility, content and outcomes conflicted with individual client and community priorities. These factors may have restricted the potential effectiveness of a programme developed and previously tested in a different social milieu. Building Blocks ISRCTN23019866 Registered 20/04/2009.",2019,"The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context.","['122 professionals participated in one of 19 focus groups', 'Methods\n\n\nFocus groups were conducted separately with Family Nurses, Health Visitors and Midwives at trial sites during 2011-2012']","['FNP', 'Family Nurse Partnership (FNP) programme', 'Building Blocks', 'Family Nurse Partnership programme', 'FNP programme']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",[],122.0,0.0371835,"The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'Clinical Nursing and Midwifery, School of Healthcare Sciences, Room 1.7, Ty Dewi Sant,Heath Park, Cardiff, CF14 4XN UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': '2Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': '3Division of Population Medicine, Cardiff University, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Bennert', 'Affiliation': 'Department of Psychology, Clinical Psychology, Bath, Somerset BA2 7AY UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Addison', 'Affiliation': '2Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': '2Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS UK.'}]",BMC nursing,['10.1186/s12912-019-0338-y']
1058,31370912,"Trajectories and Predictors of Children's Early-Starting Conduct Problems: Child, Family, Genetic, and Intervention Effects.","Several research teams have previously traced patterns of emerging conduct problems (CP) from early or middle childhood. The current study expands on this previous literature by using a genetically-informed, experimental, and long-term longitudinal design to examine trajectories of early-emerging conduct problems and early childhood discriminators of such patterns from the toddler period to adolescence. The sample represents a cohort of 731 toddlers and diverse families recruited based on socioeconomic, child, and family risk, varying in urbanicity and assessed on nine occasions between ages 2 and 14. In addition to examining child, family, and community level discriminators of patterns of emerging conduct problems, we were able to account for genetic susceptibility using polygenic scores and the study's experimental design to determine whether random assignment to the Family Check-Up (FCU) discriminated trajectory groups. In addition, in accord with differential susceptibility theory, we tested whether the effects of the FCU were stronger for those children with higher genetic susceptibility. Results augmented previous findings documenting the influence of child (inhibitory control [IC], gender) and family (harsh parenting, parental depression, and educational attainment) risk. In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility. Implications are discussed for early identification and specifically, prevention efforts addressing early child and family risk.",2019,"In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility.","['731 toddlers and diverse families recruited based on socioeconomic, child, and family risk, varying in urbanicity and assessed on nine occasions between ages 2 and 14']",[],"['child (inhibitory control [IC], gender) and family (harsh parenting, parental depression, and educational attainment) risk']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",731.0,0.0284405,"In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility.","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chardée A', 'Initials': 'CA', 'LastName': 'Galán', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lemery-Chalfant', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kit K', 'Initials': 'KK', 'LastName': 'Elam', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Department of Social Policy & Intervention, University of Oxford, Oxford, UK.'}]",Development and psychopathology,['10.1017/S0954579419000828']
1059,30982972,Optimal reassessment time for treatment response in posterior canal benign paroxysmal positional vertigo.,"OBJECTIVES/HYPOTHESIS


The present study aimed to evaluate the optimal reassessment time for treatment response in posterior canal benign paroxysmal positional vertigo (PC-BPPV) following the initial Epley maneuver.
STUDY DESIGN


Prospective, single-blinded, randomized study.
METHODS


One hundred eight patients with PC-BPPV agreed to participate. These patients received a single modified Epley maneuver (recommended by the 2008 American Academy of Otolaryngology-Head and Neck Surgery guidelines) daily until positional nystagmus disappeared during the Dix-Hallpike maneuver 24 hours after the treatment. Repeated Dix-Hallpike testing to reassess the treatment response was performed at 1 hour (post-1 hour), every 24 hours (post-24 hours) until the positional nystagmus resolved, 1 week (post-1 week), and 1 month (post-1 month) following the therapeutic maneuver. The difference in the resolution rates at post-1 hour and post-24 hours reassessment was analyzed, and the recurrence rates at post-1 week and post-1 month were evaluated.
RESULTS


The resolution rate was 67.6% at post-1 hour, which increased to 79.6% at post-24 hours reassessment. There was a statistically significant difference in the results of the Dix-Hallpike test between post-1 hour and post-24 hours follow-up. After complete resolution, nine out of 108 patients (8.3%) demonstrated recurrence within 1 month.
CONCLUSIONS


Reassessment after 24 hours following the initial Epley maneuver is more advantageous than a 1-hour follow-up in patients with PC-BPPV. This information may be helpful for clinicians in deciding the appropriate follow-up period after treatment for PC-BPPV.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:496-499, 2020.",2020,There was a statistically significant difference in the results of the Dix-Hallpike test between post-1 hour and post-24 hours follow-up.,"['posterior canal benign paroxysmal positional vertigo (PC-BPPV', 'One hundred eight patients with PC-BPPV agreed to participate', 'posterior canal benign paroxysmal positional vertigo']",['single modified Epley maneuver'],"['resolution rates', 'Dix-Hallpike test', 'recurrence', 'recurrence rates', 'resolution rate']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1279393', 'cui_str': 'Epley maneuver (procedure)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",108.0,0.0791666,There was a statistically significant difference in the results of the Dix-Hallpike test between post-1 hour and post-24 hours follow-up.,"[{'ForeName': 'Mee Hyun', 'Initials': 'MH', 'LastName': 'Song', 'Affiliation': 'Department of Otorhinolaryngology, Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Yonsei University Wonju College of Medicine, Wonju, South Korea.'}, {'ForeName': 'Dae Bo', 'Initials': 'DB', 'LastName': 'Shim', 'Affiliation': 'Department of Otorhinolaryngology, Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}]",The Laryngoscope,['10.1002/lary.28005']
1060,30823563,Consumption of Animal-Source Protein is Associated with Improved Height-for-Age  z  Scores in Rural Malawian Children Aged 12⁻36 Months.,"Linear growth faltering, caused by insufficient diet, recurrent infections and environmental enteric dysfunction (EED), continues to plague young children in low- and middle-income countries (LMICs). Diets in LMICs are primarily plant based, and thus have poor-quality protein and low levels of essential micronutrients. The aim of this study was to assess the association of the type and protein quality of food consumed with stunting, EED and acute malnutrition in children aged 6⁻36 months in Limera and Masenjere, two rural Southern Malawian communities. This is a secondary analysis of two randomized controlled trials that tested the effects of common bean and cowpea flour on stunting in children aged 6⁻36 months. We used data from two interactive 24-h dietary recalls conducted 12 weeks after enrolment into each trial. Food intakes were compared between the regions using Chi-square and Student's  t -test. There were 355 children that participated in the dietary recalls. The diets of children were of poor quality, but the children from Limera consumed more fish (54% vs. 35%,  p  = 0.009) and more bioavailable protein (26.0 ± 10.3 g/day vs. 23.1 ± 8.1 g/day,  p  = 0.018, respectively) than children in Masenjere. Food type and protein quality were not associated with any of the outcomes except an association between animal protein consumption and improvement in height-for-age  z  scores in children aged 12⁻36 months ( p  = 0.047). These findings support the notion that animal-source food (ASF) consumption in this vulnerable population promotes linear growth.",2019,Food type and protein quality were not associated with any of the outcomes except an association between animal protein consumption and improvement in height-for-age  z  scores in children aged 12⁻36 months ( p  = 0.047).,"['children aged 6⁻36 months in Limera and Masenjere, two rural Southern Malawian communities', 'Rural Malawian Children Aged 12⁻36 Months', '355 children that participated in the dietary recalls', 'plague young children in low- and middle-income countries (LMICs', 'children aged 6⁻36 months']",['common bean and cowpea flour'],"['Food type and protein quality', 'Food intakes', 'bioavailable protein']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032064', 'cui_str': 'Yersinia pestis Infection'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0996862', 'cui_str': 'Vigna'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]",355.0,0.0643817,Food type and protein quality were not associated with any of the outcomes except an association between animal protein consumption and improvement in height-for-age  z  scores in children aged 12⁻36 months ( p  = 0.047).,"[{'ForeName': 'Yankho', 'Initials': 'Y', 'LastName': 'Kaimila', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. ykaimila1@gmail.com.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Divala', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. odivala@yahoo.com.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Agapova', 'Affiliation': 'Washington University School of Medicine, Department of Pediatrics, Campus Box 8116, St. Louis, MO 63110, USA. shtepaz@gmail.com.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Stephenson', 'Affiliation': 'Washington University School of Medicine, Department of Pediatrics, Campus Box 8116, St. Louis, MO 63110, USA. kbstephe@gmail.com.'}, {'ForeName': 'Chrissie', 'Initials': 'C', 'LastName': 'Thakwalakwa', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. cthakwalakwa@yahoo.com.'}, {'ForeName': 'Indi', 'Initials': 'I', 'LastName': 'Trehan', 'Affiliation': 'Washington University School of Medicine, Department of Pediatrics, Campus Box 8116, St. Louis, MO 63110, USA. itrehan@wustl.edu.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. manarymj@wustl.edu.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. kmaleta@medcol.mw.'}]",Nutrients,['10.3390/nu11020480']
1061,31840424,Clinical evidences of benefits from an advanced skin care routine in comparison with a simple routine.,"BACKGROUND


The use of a skin care routine is commonly promoted by the cosmetic industry, yet there is a lack of clinical evidence to support this practice over the use of a single skin care product.
AIMS


In the present study, we aimed at showing the clinical benefits of using a comprehensive skin care routine vs a simple one.
METHODS


Skin micro-/macro-topographic, skin color, and superficial/deep hydration were collected at baseline and after 4 weeks of use, on forty-nine women randomly allocated to two groups. The first one followed the use of an advanced routine (AR: Cleanser/Toner/Eye cream/Serum/Day & Night cream), while the other group was instructed to use a simple routine (SR: Cleanser & Day cream).
RESULTS


Hemoglobin heterogeneity was found to be significantly reduced only in the SR group. However, the AR outperformed the SR when it comes to improving superficial hydration, deep hydration, skin roughness, mean pore area, melanin heterogeneity, and crow's feet wrinkle depth. A significant increase in skin brightness from baseline was only recorded when using the AR while both routines significantly improved the nasolabial wrinkles.
CONCLUSION


These findings advocate for using a relevant daily routine as it demonstrates the visible skin benefits over a short period, while driving the creation of habits for the prevention of aging signs.",2020,"However, the AR outperformed the SR when it comes to improving superficial hydration, deep hydration, skin roughness, mean pore area, melanin heterogeneity, and crow's feet wrinkle depth.","['Skin micro-/macro-topographic, skin color, and superficial/deep hydration were collected at baseline and after 4\xa0weeks of use, on forty-nine women randomly allocated to two groups']","['simple routine (SR: Cleanser & Day cream', 'advanced routine (AR: Cleanser/Toner/Eye cream/Serum/Day & Night cream', 'comprehensive skin care routine vs a simple one']","['Hemoglobin heterogeneity', 'skin brightness', 'nasolabial wrinkles', ""superficial hydration, deep hydration, skin roughness, mean pore area, melanin heterogeneity, and crow's feet wrinkle depth""]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0037290', 'cui_str': 'Skin Tone'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0993163', 'cui_str': 'Ophthalmic Cream'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}]",49.0,0.0184621,"However, the AR outperformed the SR when it comes to improving superficial hydration, deep hydration, skin roughness, mean pore area, melanin heterogeneity, and crow's feet wrinkle depth.","[{'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Messaraa', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Robertson', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hurley', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Doyle', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mansfield', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Daly', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Tansey', 'Affiliation': 'Oriflame R&D, Bray, Ireland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Mavon', 'Affiliation': 'Oriflame Skin Research Institute, Oriflame Cosmetics AB, Stockholm, Sweden.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13252']
1062,30970218,Supplementation with dietary ω-3 mitigates immobilization-induced reductions in skeletal muscle mitochondrial respiration in young women.,"Omega-3 (ω-3) supplementation attenuates immobilization-induced atrophy; however, the underlying mechanisms remain unclear. Since mitochondrial dysfunction and oxidative stress have been implicated in muscle atrophy, we examined whether ω-3 supplementation could mitigate disuse-mediated mitochondrial dysfunction. Healthy young women (age = 22 ± 3 yr) randomly received control ( n  = 9) or ω-3 supplementation ( n  = 11; 3 g eicosapentaenoic acid, 2 g docosahexaenoic acid) for 4 wk prior to and throughout 2 wk of single-limb immobilization. Biopsies were performed before and after 3 and 14 d of immobilization for the assessment of mitochondrial respiration, H 2 O 2  emission, and markers of ADP transport/lipid metabolism. In controls, immobilization rapidly (3 d) reduced (∼20%) ADP-stimulated mitochondrial respiration without altering ADP sensitivity or the abundance of mitochondrial proteins. Extending immobilization to 14 d did not further reduce mitochondrial coupled respiration; however, unlike following 3 d, mitochondrial proteins were reduced ∼20%. In contrast, ω-3 supplementation prevented immobilization-induced reductions in mitochondrial content and respiration throughout the immobilization period. Regardless of dietary supplement, immobilization did not alter mitochondrial H 2 O 2  emission in the presence or absence of ADP, markers of cellular redox state, mitochondrial lipid-supported respiration, or lipid-related metabolic proteins. These data highlight the rapidity of mitochondrial adaptations in response to muscle disuse, challenge the necessity for increased oxidative stress during inactivity, and establish that ω-3 supplementation preserves oxidative phosphorylation function and content during immobilization.-Miotto, P. M., McGlory, C., Bahniwal, R., Kamal, M., Phillips, S. M., Holloway, G. P. Supplementation with dietary ω-3 mitigates immobilization-induced reductions in skeletal muscle mitochondrial respiration in young women.",2019,"Extending immobilization to 14 d did not further reduce mitochondrial coupled respiration; however, unlike following 3 d, mitochondrial proteins were reduced ∼20%.","['Healthy young women (age = 22 ± 3 yr) randomly received', 'young women']","['ADP-stimulated mitochondrial respiration', 'eicosapentaenoic acid, 2 g docosahexaenoic acid', 'control ( n  = 9) or ω-3 supplementation', 'Omega-3 (ω-3) supplementation']","['skeletal muscle mitochondrial respiration', 'mitochondrial content and respiration']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.0362044,"Extending immobilization to 14 d did not further reduce mitochondrial coupled respiration; however, unlike following 3 d, mitochondrial proteins were reduced ∼20%.","[{'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Miotto', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Ontario, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ravninder', 'Initials': 'R', 'LastName': 'Bahniwal', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Holloway', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Ontario, Canada.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.201900095R']
1063,31811839,Prophylactic vaginal dinoprostone administration six hours prior to copper-T380A intrauterine device insertion in nulliparous women: A randomized controlled trial.,"OBJECTIVE


To determine the effectiveness of 3 mg vaginal dinoprostone administered six hours prior to copper intrauterine device (IUD) insertion compared to placebo in increasing ease of insertion and reducing insertion pain among nulliparous women.
STUDY DESIGN


This was a single-center double-blinded randomized controlled trial (RCT). We randomly divided the two hundred nulliparous women requesting a copper T380A IUD to receive 3 mg vaginal dinoprostone or placebo six hours before IUD insertion. The primary outcome was provider ease of insertion. Patients reported their perceived insertion pain using a 10 cm visual analog scale (VAS). We also reported number of failed IUD insertions.
RESULTS


Baseline characteristics were similar between groups. Ease of insertion score was lower in dinoprostone group than placebo group (3.6 ± 2.5 vs. 5.4 ± 2.8; p < 0.01) denoting easier insertion for clinicians in dinoprostone group. Mean pain score during copper IUD insertion was lower in dinoprostone group (3.7 ± 2.3 vs. 5.0 ± 2.8; p < 0.01). Failed IUD insertion occurred in two cases of dinoprostone group (2%) versus four cases in control group (4%) (p-value; 0.68).
CONCLUSIONS


Although vaginal dinoprostone administration six hours prior to copper IUD insertion in nulliparous women leads to an easy IUD insertion, we do not routinely advise it as the reduction in IUD insertion pain scores with vaginal dinoprostone lacked clinical significance.
IMPLICATIONS


In settings where it is feasible to provide dinoprostone vaginally six hours before copper IUD insertion, clinicians will find insertion easier, and nulliparous women may experience somewhat less pain during the procedure. Where waiting six hours is practical, this may prove to be useful.",2020,"Failed IUD insertion occurred in two cases of dinoprostone group (2%) versus four cases in control group (4%) (p-value; 0.68).
","['nulliparous women', 'two hundred nulliparous women requesting a']","['Prophylactic vaginal dinoprostone administration six hours prior to copper-T380A intrauterine device insertion', 'copper T380A IUD to receive 3\u202fmg vaginal dinoprostone or placebo', 'dinoprostone', 'placebo', 'vaginal dinoprostone']","['Ease of insertion score', 'provider ease of insertion', 'insertion pain using a 10\u202fcm visual analog scale (VAS', 'Mean pain score during copper IUD insertion', 'Failed IUD insertion']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}]",,0.713033,"Failed IUD insertion occurred in two cases of dinoprostone group (2%) versus four cases in control group (4%) (p-value; 0.68).
","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Fikry Yosif', 'Initials': 'MFY', 'LastName': 'Kasem', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Lithy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Mahy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr Hassan', 'Initials': 'AH', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'A-Wahab', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amal Hanafy', 'Initials': 'AH', 'LastName': 'Hussien', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A Mageed A', 'Initials': 'AAMA', 'LastName': 'Allah', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Alaa', 'Initials': 'AA', 'LastName': 'El Din Wali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hossam H', 'Initials': 'HH', 'LastName': 'Soliman', 'Affiliation': 'Al Gala Maternity Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Ahmed Taher', 'Initials': 'AT', 'LastName': 'Masoud', 'Affiliation': 'Faculty of Medicine, Fayoum University, Egypt. Electronic address: at1263@fayoum.edu.eg.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Abdou', 'Affiliation': 'Helwan University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rana M', 'Initials': 'RM', 'LastName': 'Abdella', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sherif Sameh', 'Initials': 'SS', 'LastName': 'Zaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Contraception,['10.1016/j.contraception.2019.10.012']
1064,31712950,Feasibility of a novel exercise prehabilitation programme in patients scheduled for elective colorectal surgery: a feasibility randomised controlled trial.,"BACKGROUND AND OBJECTIVES


To investigate the feasibility of delivering a functional exercise-based prehabilitation intervention and its effects on postoperative length of hospital stay, preoperative physical functioning and health-related quality of life in elective colorectal surgery.
MATERIALS AND METHODS


In this randomised controlled feasibility trial, 22 elective colorectal surgery patients were randomly assigned to exercise prehabilitation (n = 11) or standard care (n = 11). Feasibility of delivering the intervention was assessed based on recruitment and compliance to the intervention. Impact on postoperative length of hospital stay and complications, preoperative physical functioning (timed up and go test, five times sit to stand, stair climb test, handgrip dynamometry and 6-min walk test) and health-related quality of life were also assessed.
RESULTS


Over 42% of patients (84/198) screened were deemed ineligible for prehabilitation due to insufficient time existing prior to scheduled surgery. Of those who were eligible, approximately 18% consented to the trial. Median length of hospital stay was 8 [range 6-27] and 10 [range 5-12] days respectively for the standard care and prehabilitation groups. Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care.
CONCLUSIONS


Despite prehabilitation appearing to convey positive benefits on physical functioning, short surgical wait times and patient engagement represent major obstacles to implementing exercise prehabilitation programmes in colorectal cancer patients.",2020,"Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care.
","['colorectal cancer patients', 'patients scheduled for elective colorectal surgery', 'Over 42% of patients (84/198) screened were deemed ineligible for prehabilitation due to insufficient time existing prior to scheduled surgery', '22 elective colorectal surgery patients']","['novel exercise prehabilitation programme', 'standard care', 'exercise prehabilitation', 'functional exercise-based prehabilitation intervention']","['Median length of hospital stay', 'stair climb test and 6-min walk test', 'postoperative length of hospital stay and complications, preoperative physical functioning (timed up and go test, five times sit to stand, stair climb test, handgrip dynamometry and 6-min walk test) and health-related quality of life', 'postoperative length of hospital stay, preoperative physical functioning and health-related quality of life']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",22.0,0.0883603,"Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care.
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Northgraves', 'Affiliation': 'Hull Health Trials Unit, University of Hull, Hull, UK.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Arunachalam', 'Affiliation': 'General Surgery, Pinderfields Hospital, Wakefield, UK.'}, {'ForeName': 'Leigh A', 'Initials': 'LA', 'LastName': 'Madden', 'Affiliation': 'Department of Biomedical Science, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Marshall', 'Affiliation': 'Sport, Health and Exercise Science, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hartley', 'Affiliation': 'Academic Surgical Unit, Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'MacFie', 'Affiliation': 'Combined Gastroenterology Research Unit, Scarborough Hospital, Scarborough, UK.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Vince', 'Affiliation': 'Sport, Health and Exercise Science, School of Life Sciences, University of Hull, Hull, UK. Rebecca.vince@hull.ac.uk.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05098-0']
1065,30937447,Standard pre-travel consultation versus shorter consultation combined with smartphone support: a randomized controlled trial.,"Immediate and long-term recalls of a pre-travel consultation are suboptimal. We aimed to assess the role of online consultation for travellers.
We randomized travellers into two study groups. In the intervention arm, each traveller was given a short pre-travel consultation of 8-12 minutes, combined with the option of smartphone support before and during the trip. In the control arm, each traveller was given a standard length pre-travel consultation of 18-22 minutes. Endpoints included knowledge about potential risks, travellers' satisfaction, time allocated to each traveller and clinical events.
We enrolled 75 patients in the intervention group and 74 patients in the control group. Online consultation was used 33 times, by 24 travellers, both before and during the trip. Important health hazards that were addressed included animal and insect bites (8), treatment of diarrhea (4), malaria prophylaxis (2) and altitude sickness prophylaxis (5). Other consultations consisted mainly of reassurances of worried travellers and provision of data. Knowledge about travel-related risks was higher in the control group before travelling (8.86 ± 1.12 vs 8.34 ± 1.32, P = 0.014), and there was a trend towards higher levels of knowledge also during the trip (8.29 ± 1.35 vs 7.89 ± 1.39, P = 0.06). Travellers' satisfaction before and during the trip was similar in both groups: median 10 (10, 10) in both groups before traveling (P = 0.51) and median 9 (8, 10) in both groups during the trip (P = 0.71). In the intervention group, time allocated to each traveller was <12 minutes. There were no differences in the number of clinical events (P > 0.2 for all comparisons).
Online WhatsApp support addressed several important travel-related hazards but, when combined with a shortened pre-travel consultation, was associated with a lower level of knowledge about health risks. Therefore, such smartphone support should augment, rather than replace, pre-travel consultation.",2019,"Knowledge about travel-related risks was higher in the control group before travelling (8.86 ± 1.12 vs 8.34 ± 1.32, P = 0.014), and there was a trend towards higher levels of knowledge also during the trip (8.29 ± 1.35 vs 7.89 ± 1.39, P = 0.06).",['enrolled 75 patients in the intervention group and 74 patients in the control group'],['Standard pre-travel consultation versus shorter consultation combined with smartphone support'],"[""Travellers' satisfaction"", 'number of clinical events', 'Knowledge about travel-related risks', ""knowledge about potential risks, travellers' satisfaction, time allocated to each traveller and clinical events""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",75.0,0.0562562,"Knowledge about travel-related risks was higher in the control group before travelling (8.86 ± 1.12 vs 8.34 ± 1.32, P = 0.014), and there was a trend towards higher levels of knowledge also during the trip (8.29 ± 1.35 vs 7.89 ± 1.39, P = 0.06).","[{'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Rozenberg', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Petersiel', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Korytny', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Bishop', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Amjad', 'Initials': 'A', 'LastName': 'Mousa', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Carmit', 'Initials': 'C', 'LastName': 'Fried', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Maister', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Neuberger', 'Affiliation': 'Travel Medicine and Tropical Diseases Clinic, Division of Infectious Diseases, Rambam Medical Center, Haifa, Israel.'}]",Journal of travel medicine,['10.1093/jtm/taz025']
1066,29037481,Surgical outcomes among elderly women with endometrial cancer treated by laparoscopic hysterectomy: a NRG/Gynecologic Oncology Group study.,"OBJECTIVE


Tolerance of and complications caused by minimally invasive hysterectomy and staging in the older endometrial cancer population is largely unknown despite the fact that this is the most rapidly growing age group in the United States. The objective of this retrospective review was to compare operative morbidity by age in patients on the Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus (LAP2) trial.
STUDY DESIGN


This is a retrospective analysis of patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage uterine cancer patients randomized to laparotomy vs laparoscopy for surgical staging. Differences in the rates and types of intraoperative and perioperative complications were compared by age. Specifically complications between patients <60 vs ≥60 years old were compared caused by toxicity analysis showing a sharp increase in toxicity starting at age 60 years in the laparotomy group.
RESULTS


LAP2 included 1477 patients ≥60 years old. As expected, with increasing age there was worsening performance status and disease characteristics including higher rates of serous histology, high-stage disease, and lymphovascular space invasion. There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups. Toxicity analysis showed a sharp increase in toxicity seen in patients ≥60 years old in the laparotomy group. Further analysis showed that when comparing laparotomy with laparoscopy in patients <60 years old vs ≥60 years old and controlling for race, body mass index, stage, grade, and performance status, patients <60 years old undergoing laparotomy had more hospital stays >2 days (odds ratio, 17.48; 95% confidence interval, 11.71-27.00, P < .001) compared with patients <60 years old undergoing laparoscopy. However, when comparing laparotomy with laparoscopy in patients ≥60 years old, in addition to hospital stay >2 days (odds ratio, 12.77; 95% confidence interval, 8.74-19.32, P < .001), there were higher rates of the following postoperative complications: antibiotic administration (odds ratio, 1.63; 95% confidence interval, 1.24-2.14, P < .001), ileus (odds ratio, 2.16; 95% confidence interval, 1.42-3.31, P <0.001), pneumonias (odds ratio, 2.36; 95% confidence interval, 1.01-5.66, P = .048), deep vein thromboses (odds ratio, 2.87; 95% confidence interval, 1.08-8.03, P = .035), and arrhythmias (odds ratio, 3.21; 95% confidence interval, 1.60-6.65, P = .001) in the laparotomy group.
CONCLUSION


Laparoscopic staging for uterine cancer is associated with decreased morbidity in the immediate postoperative period in patients ≥60 years old. These results allow for more accurate preoperative counseling. A minimally invasive approach to uterine cancer staging may decrease morbidity that could affect long-term survival.",2018,There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups.,"['patients <60 years old undergoing laparoscopy', 'patients on the', 'patients ≥60 years old in the laparotomy group', 'patients ≥60 years old', 'With Endometrial Cancer or Cancer of the Uterus (LAP2) trial', 'elderly women with endometrial cancer\xa0treated by', '1477 patients ≥60 years old', 'older endometrial cancer population', 'patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage uterine cancer patients randomized to']","['laparoscopic hysterectomy', 'Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery', 'Laparoscopic staging', 'laparotomy vs laparoscopy']","['toxicity starting', 'hospital stays', 'deep vein\xa0thromboses', 'lymph node dissection rate', 'operative morbidity', 'rates and types of intraoperative and perioperative complications', 'postoperative complications: antibiotic administration', 'arrhythmias', 'toxicity seen', 'ileus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0153567', 'cui_str': 'Cancer of Uterus'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0297197', 'cui_str': 'lamina-associated polypeptide 2'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}]",1477.0,0.293865,There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups.,"[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bishop', 'Affiliation': 'Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK. Electronic address: erbishop@mcw.edu.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Java', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""Women's Cancer Center, Las Vegas, NV.""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Department of Gynecologic Oncology, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Division of Gynecologic Oncology, Memorial Sloan-Kettering Cancer Center, New York City, NY.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kushner', 'Affiliation': 'Department of Gynecologic Oncology, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Floor', 'Initials': 'F', 'LastName': 'Backes', 'Affiliation': 'Wexner Medical Center, Ohio State University, Hilliard, OH.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Gynecologic Oncology Service, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Geller', 'Affiliation': 'University of Minnesota School of Medicine, Minneapolis, MN.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hurteau', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Chicago Pritzker School of Medicine, NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'Department of Gynecologic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology, M. D. Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zweizig', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': 'Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2017.09.026']
1067,31622777,GIP's effect on bone metabolism is reduced by the selective GIP receptor antagonist GIP(3-30)NH 2 .,"Infusion of the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) suppresses the bone resorption marker carboxy-terminal type 1 collagen crosslinks (CTX). Using separate and combined infusions of the selective GIP receptor (GIPR) antagonist, GIP(3-30)NH 2 , and GIP, we investigated how GIPR inhibition affects bone turnover markers. Ten healthy men (median age 22.5 years (range 21-25), BMI 21.3kg/m 2  (19.9-24.7)) participated in a randomized, doubled blinded, placebo-controlled, crossover study with four 1h 12mmol/l-hyperglycemic clamps on four separate study days with concomitant infusions of GIP, GIP+GIP(3-30)NH 2 , GIP(3-30)NH 2 , and placebo, respectively, separated by a period of at least one week. GIP was infused at 1.5pmol/kg/min and GIP(3-30)NH 2  at 800pmol/kg/min. Plasma glucose was clamped at 12.0±1.2mmol/l and plasma levels of GIP and GIP(3-30)NH 2  amounted to ∼80pmol/l and ∼50nmol/l, respectively. GIP suppressed CTX more than placebo (baseline-subtracted AUC -6,811±1,260 vs. -3,012±3,018ng/l×min, P= 0.002) and resulted in CTX values of 53 ± 6.9% (GIP) versus 81 ± 10% of baseline (placebo), respectively (P = 0.0006), at the end of the hyperglycemic clamp. Co-infusion of GIP and GIP(3-30)NH 2  attenuated the GIP-induced CTX suppression by 51±33% (P = 0.01). The peak value of the bone formation marker N-terminal propeptide of type 1 procollagen (P1NP) peaked at higher levels during GIP (109±6.7% of baseline) than during GIP(3-30)NH 2  infusion (101±8.9%) (P = 0.049) and GIP suppressed PTH levels compared to GIP(3-30)NH 2  alone (P = 0.0158). In conclusion, blockade of the GIPR with GIP(3-30)NH 2  diminished GIP-induced CTX and P1NP responses, showing that these effects are GIPR-mediated and that GIPR antagonism might interfere with bone resorption.",2020,Co-infusion of GIP and GIP(3-30)NH 2  attenuated the GIP-induced CTX suppression by 51 ± 33% (P = 0.01).,"['Ten healthy men (median age 22.5 years (range 21-25), BMI 21.3\u2009kg/m 2  (19.9-24.7']","['placebo', 'selective GIP receptor (GIPR) antagonist, GIP(3-30)NH 2 , and GIP', 'GIP, GIP\u2009+\u2009GIP(3-30)NH 2 , GIP(3-30)NH 2 , and placebo', 'incretin hormone glucose-dependent insulinotropic polypeptide (GIP']","['GIP suppressed CTX', 'bone metabolism', 'Plasma glucose', 'GIP-induced CTX suppression', 'GIP suppressed PTH levels', 'peak value of the bone formation marker N-terminal propeptide of type 1 procollagen (P1NP', 'CTX values']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061126', 'cui_str': 'glucose-dependent insulinotropic polypeptide receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}]","[{'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}]",10.0,0.121387,Co-infusion of GIP and GIP(3-30)NH 2  attenuated the GIP-induced CTX suppression by 51 ± 33% (P = 0.01).,"[{'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark. Electronic address: filip.krag.knop.01@regionh.dk.'}]",Bone,['10.1016/j.bone.2019.115079']
1068,31712013,Effect of 6-week washout period on intraocular pressure following chronic prostaglandin analogue treatment: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of a 6-week washout period on intraocular pressure (IOP) following long-term monotherapy prostaglandin use.
DESIGN


Prospective, randomized, controlled, single-centre, single-blinded, parallel-group clinical study.
PARTICIPANTS


Subjects aged >18 years diagnosed with open-angle glaucoma or open-angle glaucoma suspects based on elevated IOP in one or both eyes, using monotherapy topical latanoprost, bimatoprost, or travoprost once daily.
METHODS


Subjects were prospectively randomized to continue prostaglandin analogue (PGA) monotherapy (control group) or discontinue PGA monotherapy (washout group) for 42 days. IOP was measured at day 0 (day of randomization), 7, 21, and 42.
MAIN OUTCOME MEASURE


Mean IOP (mm Hg) ± standard deviation.
RESULTS


154 eyes (87 participants) completed the study, with 69 eyes (39 participants) in the control group and 85 eyes (48 participants) in the washout group. In the control group, day 0 IOP (14.64 ± 2.68 mm Hg) did not significantly differ from IOP at days 7 (14.25 ± 3.01 mm Hg), 21 (14.57 ± 2.61 mm Hg), and 42 (14.78 ± 2.30 mm Hg) (all p > 0.30). In the washout group, mean IOP values at days 7 (16.19 ± 3.80 mm Hg), 21 (17.28 ± 3.55 mm Hg), and 42 (17.84 ± 3.31 mm Hg) were significantly greater than those at day 0 (14.48 ± 1.94 mm Hg) and day-matched control group values (all p < 0.002). In the washout group, 24.7% of eyes had a day 42 IOP ≥21 mm Hg. No eyes in the control group had a day 42 IOP ≥21 mm Hg.
CONCLUSIONS


Six weeks of PGA washout after long-term monotherapy resulted in a small but statistically significant IOP increase. Majority of washout group participants maintained an IOP lower than 21 mm Hg after the 6-week washout duration. (https://clinicaltrials.gov/ identifier, NCT03534882).",2020,"IOP (14.64 ± 2.68 mm Hg) did not significantly differ from IOP at days 7 (14.25 ± 3.01 mm Hg), 21 (14.57 ± 2.61 mm Hg), and 42 (14.78 ± 2.30 mm Hg) (all p > 0.30).","['154 eyes (87 participants) completed the study, with 69 eyes (39 participants) in the control group and 85 eyes (48 participants) in the washout group', 'Subjects', 'Subjects aged >18 years diagnosed with open-angle glaucoma or open-angle glaucoma suspects based on elevated IOP in one or both eyes, using']","['monotherapy topical latanoprost, bimatoprost, or travoprost once daily', 'prostaglandin analogue (PGA) monotherapy (control group) or discontinue PGA monotherapy', 'chronic prostaglandin analogue treatment']","['intraocular pressure', 'intraocular pressure (IOP', 'mean IOP values', 'Mean IOP (mm Hg) ± standard deviation', 'IOP']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C0937916', 'cui_str': 'travoprost'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin Analogs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",87.0,0.195139,"IOP (14.64 ± 2.68 mm Hg) did not significantly differ from IOP at days 7 (14.25 ± 3.01 mm Hg), 21 (14.57 ± 2.61 mm Hg), and 42 (14.78 ± 2.30 mm Hg) (all p > 0.30).","[{'ForeName': 'Carter W', 'Initials': 'CW', 'LastName': 'Lim', 'Affiliation': 'University of Ottawa Faculty of Medicine, Ottawa, Ont.; Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, London, Ont.. Electronic address: carterwlim@gmail.com.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Diaconita', 'Affiliation': ""Ivey Eye Institute, St. Joseph's Health Care, London, Ont.; Schulich School of Medicine and Dentistry, Western University, London, Ont.""}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, Ont.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ault', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, Ont.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lizotte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ont.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Schulich School of Medicine and Dentistry, Western University, London, Ont.'}, {'ForeName': 'Cindy M L', 'Initials': 'CML', 'LastName': 'Hutnik', 'Affiliation': ""Ivey Eye Institute, St. Joseph's Health Care, London, Ont.; Schulich School of Medicine and Dentistry, Western University, London, Ont.""}]",Canadian journal of ophthalmology. Journal canadien d'ophtalmologie,['10.1016/j.jcjo.2019.08.004']
1069,31838255,"Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial.","The optimal systolic blood pressure (SBP) treatment target in elderly people is full of challenge, and non-adherence is one major cause of uncontrolled BP. The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial is a multi-center, randomized controlled trial that aims to examine whether an intensive treatment (110 ≤ SBP < 130 mmHg) will provide more benefits in lowering cardiovascular events than a mild treatment (130 ≤ SBP < 150 mmHg) among people aged 60-80 years. From January 10, 2017 to December 31, 2017, 8511 patients with primary hypertension were recruited at 42 clinical centers throughout China and randomly assigned to the intensive or standard treatment in 1:1 ratio, in which clinical sites are considered as a stratification factor in randomization. Participants will be followed for an average of four years. All participants used the same validated home BP device and all centers used the same validated office BP device which can automatically upload the readings to a data center. The hospitals were randomly classified as the smartphone-based App center or usual care center in 1:1 ratio for the secondary purpose to study the effect of App management on BP control. In this trial, mean age of participants was 66.2 ± 4.8 years, 24.1% were in the range of 70-80 years, and 65% were at high-risk with the 10-year Framingham risk score ≥ 15%. In conclusion, STEP will provide evidence not only to address appropriate target of BP control among hypertensive patients aged 60-80 years, but also to assess an effective model of App management for hypertension. Trial Registration number: ClinicalTrials. gov. Unique identifier: NCT03015311.",2020,"The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial is a multi-center, randomized controlled trial that aims to examine whether an intensive treatment (110 ≤ SBP < 130 mmHg) will provide more benefits in lowering cardiovascular events than a mild treatment (130 ≤ SBP < 150 mmHg) among people aged 60-80 years.","['elderly hypertensive patients (STEP', 'Elderly Hypertensive Patients (STEP', 'hypertensive patients aged 60-80\u202fyears', 'elderly people', 'people aged 60-80\u202fyears', 'From January 10, 2017 to December 31, 2017, 8511 patients with primary hypertension were recruited at 42 clinical centers throughout China', 'mean age of participants was 66.2\u202f±\u202f4.8\u202fyears, 24.1% were in the range of 70-80\u202fyears, and 65% were at high-risk with the 10-year Framingham risk score\u202f≥\u202f15']","['blood pressure intervention', 'intensive treatment (110\u202f≤\u202fSBP\u202f<\u202f130\u202fmmHg', 'smartphone-based App center or usual care center', 'Blood Pressure Intervention']",['optimal systolic blood pressure (SBP'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",,0.0860429,"The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial is a multi-center, randomized controlled trial that aims to examine whether an intensive treatment (110 ≤ SBP < 130 mmHg) will provide more benefits in lowering cardiovascular events than a mild treatment (130 ≤ SBP < 150 mmHg) among people aged 60-80 years.","[{'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Hypertension Center, FuWai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100037, China.'}, {'ForeName': 'Shouling', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Kailuan General Hospital, Tangshan, Hebei 063000, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.'}, {'ForeName': 'Yingqing', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Guangdong Cardiovascular Institute, Guangzhou, Guangdong 510080, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Bingpo', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Kang Ya Hospital, Yiyang, Hunan 413000, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""The People's Hospital of Ji Xian District, Tianjin 301900, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Tian', 'Affiliation': ""First Affiliated Hospital, Xian Jiaotong University, Xi'an, Shanxi 710061, China.""}, {'ForeName': 'Yinong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The 1st Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Zihong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Fuwai Yunnan Cardiovascular Hospital, Kunming, Yunnan 650106, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Pingjin Hospital, Logistics University of PAPF, Tianjin 300162, China.'}, {'ForeName': 'Tzung-Dau', 'Initials': 'TD', 'LastName': 'Wang', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan 10051, China.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University School of Medicine (JMU), Shimotsuke, Tochigi 329-0498, Japan.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Hypertension Center, FuWai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100037, China. Electronic address: zhangweili1747@yahoo.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Hypertension Center, FuWai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100037, China. Electronic address: caijun7879@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105913']
1070,30898609,Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome: ODYSSEY OUTCOMES Trial.,"BACKGROUND


Patients with acute coronary syndrome (ACS) and concomitant noncoronary atherosclerosis have a high risk of major adverse cardiovascular events (MACEs) and death. The impact of lipid lowering by proprotein convertase subtilisin-kexin type 9 inhibition in such patients is undetermined.
OBJECTIVES


This pre-specified analysis from ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) determined whether polyvascular disease influenced risks of MACEs and death and their modification by alirocumab in patients with recent ACS and dyslipidemia despite intensive statin therapy.
METHODS


Patients were randomized to alirocumab or placebo 1 to 12 months after ACS. The primary MACEs endpoint was the composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint.
RESULTS


Median follow-up was 2.8 years. Of 18,924 patients, 17,370 had monovascular (coronary) disease, 1,405 had polyvascular disease in 2 beds (coronary and peripheral artery or cerebrovascular), and 149 had polyvascular disease in 3 beds (coronary, peripheral artery, cerebrovascular). With placebo, the incidence of MACEs by respective vascular categories was 10.0%, 22.2%, and 39.7%. With alirocumab, the corresponding absolute risk reduction was 1.4% (95% confidence interval [CI]: 0.6% to 2.3%), 1.9% (95% CI: -2.4% to 6.2%), and 13.0% (95% CI: -2.0% to 28.0%). With placebo, the incidence of death by respective vascular categories was 3.5%, 10.0%, and 21.8%; the absolute risk reduction with alirocumab was 0.4% (95% CI: -0.1% to 1.0%), 1.3% (95% CI: -1.8% to 4.3%), and 16.2% (95% CI: 5.5% to 26.8%).
CONCLUSIONS


In patients with recent ACS and dyslipidemia despite intensive statin therapy, polyvascular disease is associated with high risks of MACEs and death. The large absolute reductions in those risks with alirocumab are a potential benefit for these patients. (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab [ODYSSEY OUTCOMES]: NCT01663402).",2019,"With alirocumab, corresponding absolute risk reduction (ARR [95% confidence interval]) was 1.4% (0.6, 2.3), 1.9% (-2.4%, 6.2%), and 13.0% (-2.0, 28.0).","['Patients with Recent Acute Coronary Syndrome and Polyvascular Disease', 'Patients with acute coronary syndrome (ACS', 'patients with recent ACS and dyslipidemia despite intensive statin therapy', 'patients with recent ACS and dyslipidemia despite intensive statin therapy, polyVD', 'Patients', '18,924 patients, 17,370 had monovascular (coronary) disease, 1,405 had polyVD in two beds (coronary and peripheral artery or cerebrovascular), and 149 had polyVD in three beds (coronary, peripheral artery, cerebrovascular']","['alirocumab', 'lipid-lowering by proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibition', 'placebo', 'alirocumab or placebo', 'Alirocumab']","['composite of coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, or unstable angina requiring hospitalization', 'incidence of death by respective vascular categories', 'incidence of MACE by respective vascular categories']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",18924.0,0.26158,"With alirocumab, corresponding absolute risk reduction (ARR [95% confidence interval]) was 1.4% (0.6, 2.3), 1.9% (-2.4%, 6.2%), and 13.0% (-2.0, 28.0).","[{'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.w.jukema@lumc.nl.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, New York.'}, {'ForeName': 'Laurien E', 'Initials': 'LE', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Latinoamerican Cardiological Studies, Cardiovascular Institute of Rosario, Rosario, Argentina.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Karpov', 'Affiliation': 'Russian Cardiological Scientific-Productive Complex, Moscow, Russian Federation.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Prieto', 'Affiliation': 'University of Chile Clinical Hospital, Santiago, Chile.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris and Paris Diderot University, Sorbonne Paris Cité, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.03.013']
1071,31300907,Laparoscopic versus open pancreaticoduodenectomy for pancreatic neuroendocrine tumors: a single-center experience.,"BACKGROUND


The efficacy and outcomes of laparoscopic resection for pancreatic neuroendocrine tumors (PNETs) are well established; however, specific data regarding the outcomes of laparoscopic pancreaticoduodenectomy (L-PD) are limited. The purpose of the present study was to compare the clinical and oncological outcomes following L-PD versus open PD (O-PD) in patients with PNETs.
METHODS


This retrospective study included 149 patients with PNETs who underwent PD at the Asan Medical Center between January 2006 and December 2017. In 58 patients, a laparoscopic approach was used (L-PD group), and in 91, an open technique was used (O-PD group).
RESULTS


The mean operative time was longer in the L-PD group than in the O-PD group (417.4 min vs. 362.2 min; p = 0.002), and the mean duration of postoperative stay was shorter in the L-PD group (12.6 days vs. 17.8 days; p < 0.001). The estimated blood loss (433.2 ml vs. 415.0 ml; p = 0.824) and the overall complication rate (34.5% vs. 38.5%; p = 0.624) did not significantly differ between the two groups. Regarding the oncological outcomes, there were no significant differences in the resection margins, tumor size, tumor grading, or T/N stage. The number of harvested lymph nodes in the L-PD group was lower than that in the O-PD group (7.1 vs. 10.8; p = 0.002). The 3-year overall survival rate was 91.9% in the L-PD group and 93.6% in the O-PD group (p = 0.974). The 3-year disease-free survival rate was 94.8% in the L-PD group and 86.7% in the O-PD group (p = 0.225).
CONCLUSIONS


L-PD is feasible for the treatment of PNETs in selected patients and has the advantages of short recovery time and reduced hospital stay. The survival rate was similar in both groups; however, due to the difference in the harvested lymph nodes, a randomized trial should confirm the oncological safety of L-PD for PNETs.",2019,The estimated blood loss (433.2 ml vs. 415.0 ml; p = 0.824) and the overall complication rate (34.5% vs. 38.5%; p = 0.624) did not significantly differ between the two groups.,"['pancreatic neuroendocrine tumors', 'patients with PNETs', '149 patients with PNETs who underwent PD at the Asan Medical Center between January 2006 and December 2017']","['laparoscopic resection', 'laparoscopic approach', 'Laparoscopic versus open pancreaticoduodenectomy', 'L-PD versus open PD (O-PD']","['resection margins, tumor size, tumor grading, or T/N stage', 'mean duration of postoperative stay', '3-year overall survival rate', 'survival rate', '3-year disease-free survival rate', 'overall complication rate', 'mean operative time', 'number of harvested lymph nodes', 'estimated blood loss']","[{'cui': 'C0242363', 'cui_str': 'Islet Cell Tumor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206663', 'cui_str': 'Primitive Neuroepithelial Neoplasms'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C0229985', 'cui_str': 'Margins of Excision'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}]",149.0,0.0460687,The estimated blood loss (433.2 ml vs. 415.0 ml; p = 0.824) and the overall complication rate (34.5% vs. 38.5%; p = 0.624) did not significantly differ between the two groups.,"[{'ForeName': 'Hanbaro', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, College of Medicine, Hallym University, Chuncheon, South Korea.'}, {'ForeName': 'Ki Byung', 'Initials': 'KB', 'LastName': 'Song', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Dae Wook', 'Initials': 'DW', 'LastName': 'Hwang', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Alshammary', 'Affiliation': 'Department of Surgery, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Song Cheol', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea. drksc@amc.seoul.kr.'}]",Surgical endoscopy,['10.1007/s00464-019-06969-7']
1072,30962136,Laparoscopic versus open liver resection in the posterosuperior segments: a sub-group analysis from the OSLO-COMET randomized controlled trial.,"BACKGROUND


Laparoscopic liver resection in the posterosuperior segments is technically challenging. This study aimed to compare the perioperative outcomes for laparoscopic and open resection of colorectal liver metastases located in the posterosuperior segments.
METHODS


This was a subgroup analysis of the OSLO-COMET randomized controlled trial, where 280 patients were randomly assigned to open or laparoscopic parenchyma-sparing liver resections of colorectal metastases. Patients with tumors in the posterosuperior segments were identified, and perioperative outcomes and health related quality of life (HRQoL) were compared.
RESULTS


We identified a total of 136 patients, 62 in the laparoscopic and 74 in the open group. The postoperative complication rate was 26% in the laparoscopic and 31% in the open group. The blood loss was less in the open group (500 vs. 250 ml, P = 0.006), but the perioperative transfusion rate was similar. The operative time was similar, while postoperative hospital stay was shorter in the laparoscopic group (2 vs. 4 days, P < 0.001). HRQoL was significantly better after laparoscopy at 1 month.
CONCLUSION


In patients undergoing laparoscopic or open liver resection of colorectal liver metastases in the posterosuperior segments, laparoscopic surgery was associated with shorter hospital stay and comparable perioperative outcomes.",2019,"The blood loss was less in the open group (500 vs. 250 ml, P = 0.006), but the perioperative transfusion rate was similar.","['Patients with tumors in the posterosuperior segments', '280 patients', 'patients undergoing', '136 patients, 62 in the laparoscopic and 74 in the open group']","['laparoscopic parenchyma-sparing liver resections of colorectal metastases', 'laparoscopic surgery', 'Laparoscopic liver resection', 'laparoscopic or open liver resection', 'Laparoscopic versus open liver resection', 'laparoscopic and open resection']","['postoperative hospital stay', 'blood loss', 'perioperative transfusion rate', 'postoperative complication rate', 'operative time', 'perioperative outcomes and health related quality of life (HRQoL', 'HRQoL', 'shorter hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",136.0,0.13975,"The blood loss was less in the open group (500 vs. 250 ml, P = 0.006), but the perioperative transfusion rate was similar.","[{'ForeName': 'Davit L', 'Initials': 'DL', 'LastName': 'Aghayan', 'Affiliation': 'The Intervention Center, Oslo University Hospital - Rikshospitalet, Oslo, Norway; Institute of Clinical Medicine, Medical Faculty, University of Oslo, Norway; Department of Surgery N1, Yerevan State Medical University After M. Heratsi, Yerevan, Armenia. Electronic address: dr.aghayan@gmail.com.'}, {'ForeName': 'Åsmund A', 'Initials': 'ÅA', 'LastName': 'Fretland', 'Affiliation': 'The Intervention Center, Oslo University Hospital - Rikshospitalet, Oslo, Norway; Institute of Clinical Medicine, Medical Faculty, University of Oslo, Norway; Department of HPB Surgery, Oslo University Hospital - Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Airazat M', 'Initials': 'AM', 'LastName': 'Kazaryan', 'Affiliation': 'The Intervention Center, Oslo University Hospital - Rikshospitalet, Oslo, Norway; Department of Surgery N1, Yerevan State Medical University After M. Heratsi, Yerevan, Armenia; Department of Surgery, Fonna Hospital Trust, Stord, Norway; Department of Faculty Surgery №2I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Mushegh A', 'Initials': 'MA', 'LastName': 'Sahakyan', 'Affiliation': 'The Intervention Center, Oslo University Hospital - Rikshospitalet, Oslo, Norway; Department of Surgery N1, Yerevan State Medical University After M. Heratsi, Yerevan, Armenia; Department of General and Laparoscopic Surgery, Central Clinical Military Hospital, Yerevan, Armenia.'}, {'ForeName': 'Vegar J', 'Initials': 'VJ', 'LastName': 'Dagenborg', 'Affiliation': 'Institute of Clinical Medicine, Medical Faculty, University of Oslo, Norway; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway; Department of Gastroenterological Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bjørn Atle', 'Initials': 'BA', 'LastName': 'Bjørnbeth', 'Affiliation': 'Department of HPB Surgery, Oslo University Hospital - Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Flatmark', 'Affiliation': 'Institute of Clinical Medicine, Medical Faculty, University of Oslo, Norway; Department of Tumor Biology, Oslo University Hospital, Oslo, Norway; Department of Gastroenterological Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Kristiansen', 'Affiliation': 'The Intervention Center, Oslo University Hospital - Rikshospitalet, Oslo, Norway; Department of Information Technology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Edwin', 'Affiliation': 'The Intervention Center, Oslo University Hospital - Rikshospitalet, Oslo, Norway; Institute of Clinical Medicine, Medical Faculty, University of Oslo, Norway; Department of HPB Surgery, Oslo University Hospital - Rikshospitalet, Oslo, Norway.'}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2019.03.358']
1073,30975599,The inflammatory response after laparoscopic and open pancreatoduodenectomy and the association with complications in a multicenter randomized controlled trial.,"BACKGROUND


The systemic inflammatory response seen after surgery seems to be related to postoperative complications. A reduction of the inflammatory response through minimally invasive surgery might therefore be the mechanism via which postoperative outcome could be improved. The aim of this study was to investigate if postoperative inflammatory markers differed between laparoscopic (LPD) and open pancreatoduodenectomy (OPD) and if there was a relationship between inflammatory markers and the occurrence of postoperative complications.
METHODS


A side study of the multicenter randomized controlled LEOPARD-2 trial comparing LPD to OPD was performed. Area under the curve (AUC) for plasma inflammatory markers, including interleukin (IL-) 6, IL-8 and C reactive protein (CRP) levels, were determined during the first 96 postoperative hours and compared between LPD and OPD, Clavien-Dindo ≥ III complications, and postoperative pancreatic fistula (POPF) grade B/C.
RESULTS


Overall, 38 patients were included (18 LPD and 20 OPD). The median AUC of IL-6 was 627 (195-1378) after LPD vs. 338 (175-694)pg/mL after OPD, (p = 0.114). The AUC of IL-8 and CRP were comparable. IL-6 levels were higher in patients with a Clavien-Dindo ≥ III complication (634[309-1489] vs. 297 [171-680], p = 0.034) and POPF grade B/C (994 [534-3265] vs. 334 [173-704], p = 0.003). In patients with a POPF grade B/C, IL-6 levels tended to be higher after LPD, as compared to OPD (3533[IQR 1133-3533] vs. 715[IQR 39-1658], p = 0.053).
CONCLUSION


LPD, as compared to OPD, did not reduce the postoperative inflammatory response. IL-6 levels were associated with postoperative complications and pancreatic fistula.",2019,"Area under the curve (AUC) for plasma inflammatory markers, including interleukin (IL-) 6, IL-8 and C reactive protein (CRP) levels, were determined during the first 96 postoperative hours and compared between LPD and OPD, Clavien-Dindo ",['38 patients were included (18 LPD and 20 OPD'],"['laparoscopic (LPD) and open pancreatoduodenectomy (OPD', 'laparoscopic and open pancreatoduodenectomy']","['POPF grade B/C', 'AUC of IL-8 and CRP', 'median AUC of IL-6', 'Area under the curve (AUC) for plasma inflammatory markers, including interleukin (IL-) 6, IL-8 and C reactive protein (CRP) levels', 'postoperative inflammatory response', 'IL-6 levels', 'postoperative inflammatory markers', '≥\xa0III complications, and postoperative pancreatic fistula (POPF) grade B/C', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C0441806', 'cui_str': 'Grade B (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}]",38.0,0.215765,"Area under the curve (AUC) for plasma inflammatory markers, including interleukin (IL-) 6, IL-8 and C reactive protein (CRP) levels, were determined during the first 96 postoperative hours and compared between LPD and OPD, Clavien-Dindo ","[{'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'van Hilst', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address: j.vanhilst@amc.nl.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Brinkman', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands; Tytgat Institute for Liver and Intestinal Research, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'de Rooij', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Clinical Epidemiologist, Department of Surgery, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Misha D', 'Initials': 'MD', 'LastName': 'Luyer', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Hendrik A', 'Initials': 'HA', 'LastName': 'Marsman', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Karsten', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Heger', 'Affiliation': 'Department of Experimental Surgery, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address: m.g.besselink@amc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2019.03.353']
1074,30948288,"Intravenous vs Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: A Randomized, Blinded Trial.","BACKGROUND


Multimodal analgesia including acetaminophen is increasingly popular for analgesia after total hip arthroplasty (THA). Intravenous (IV) administration of acetaminophen has pharmacokinetic benefits, but unclear clinical advantages. The authors hypothesized that IV acetaminophen would reduce pain with activity, opioid usage, or opioid-related side effects, compared to oral acetaminophen.
METHODS


In this double-blinded, randomized, controlled trial, 154 THA patients received either IV or oral acetaminophen as part of a comprehensive opioid-sparing multimodal analgesia strategy. Primary outcomes were pain with physical therapy on postoperative day (POD) 1, opioid side effects (POD 1), and cumulative opioid use.
RESULTS


There was no difference in opioid side effects, pain scores, or opioid use between the groups.
CONCLUSION


Patients in both groups had low pain scores, minimal opioid side effects, and limited opioid usage (corresponding to 6 doses of tramadol 100 mg over 3 days). This highlights multimodal analgesia as an effective method of pain control for THA.",2019,"There was no difference in opioid side effects, pain scores, or opioid use between the groups.
","['After Total Hip Arthroplasty', '154 THA patients', 'total hip arthroplasty (THA']","['tramadol', 'comprehensive opioid-sparing multimodal analgesia strategy', 'Intravenous vs Oral Acetaminophen', 'IV or oral acetaminophen', 'acetaminophen']","['pain with physical therapy on postoperative day (POD', 'opioid side effects (POD 1), and cumulative opioid use', 'opioid side effects, pain scores, or opioid use', 'pain with activity, opioid usage, or opioid-related side effects', 'low pain scores, minimal opioid side effects']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]",154.0,0.485813,"There was no difference in opioid side effects, pain scores, or opioid use between the groups.
","[{'ForeName': 'Geoffrey H', 'Initials': 'GH', 'LastName': 'Westrich', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Birch', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Ahava R', 'Initials': 'AR', 'LastName': 'Muskat', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Padgett', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Enrique A', 'Initials': 'EA', 'LastName': 'Goytizolo', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Mathias P', 'Initials': 'MP', 'LastName': 'Bostrom', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mayman', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Jacques T', 'Initials': 'JT', 'LastName': 'YaDeau', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.030']
1075,31713631,Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results of the SPAIN study.,"AIMS


Reflex vasovagal syncope (VVS) is the most common cause of syncope and patients with recurrent episodes may severely impair quality of life (QoL). This pre-specified analysis evaluated whether the clinically significant reduction in syncope burden demonstrated by dual-chamber pacing with closed loop stimulation (DDD-CLS) reported in the SPAIN trial translates into improved QoL.
METHODS AND RESULTS


Patients aged ≥40 years with ≥5 VVS episodes and cardioinhibitory response induced by head-up tilt testing were included. Patients were randomized 1:1 to active DDD-CLS pacing algorithm for 12 months followed by sham DDI mode for the remaining 12 months (Group A) or vice versa (Group B). QoL was assessed using the Short Form-36 (SF-36) health survey, Physical Component Score (PCS), and Mental Component Score (MCS) before randomization (baseline) and at 12- and 24-month follow-up. Fifty-four patients were enrolled from 11 participating centres. No significant carryover effect was detected for any variable, and the only period effect was observed in the vitality subdomain (P = 0.033). Mean SF-36 scores were higher in the DDD-CLS group vs. the DDI group for the eight subdomains and significantly different in physical role, bodily pain, and vitality (P < 0.05). The analysis of component summary scores indicated that DDD-CLS benefited both mental and physical components with significant differences in PCS when compared with the DDI group.
CONCLUSION


Dual-chamber pacing with closed loop stimulation determined a significant and clinically relevant improvement in QoL across both mental and physical components in patients with recurrent VVS.
REGISTRATION


Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study); NCT01621464.",2020,"Mean SF-36 scores were higher in the DDD-CLS group vs. the DDI group for the eight subdomains and significantly different in physical role, bodily pain, and vitality (P < 0.05).","['Patients aged ≥40\u2009years with ≥5', 'patients with recurrent reflex vasovagal syncope', 'patients with recurrent VVS', 'Fifty-four patients were enrolled from 11 participating centres']","['active DDD-CLS pacing algorithm', 'dual-chamber pacing with closed loop stimulation (DDD-CLS', 'dual-chamber pacing with closed loop stimulation']","['physical role, bodily pain, and vitality', 'quality of life', 'Mean SF-36 scores', 'syncope burden', 'carryover effect', 'vitality subdomain', 'VVS episodes and cardioinhibitory response', 'Short Form-36 (SF-36) health survey, Physical Component Score (PCS), and Mental Component Score (MCS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0011037', 'cui_str': 'Dichlorodiphenyldichloroethane'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0002045'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",54.0,0.0590439,"Mean SF-36 scores were higher in the DDD-CLS group vs. the DDI group for the eight subdomains and significantly different in physical role, bodily pain, and vitality (P < 0.05).","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Barón-Esquivias', 'Affiliation': 'Department of Cardiology, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Sevilla. Av. Manuel Siurot, S/n, 41013 Sevilla, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Moya-Mitjans', 'Affiliation': 'Agencia de Investigación de la Sociedad Española de Cardiología, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Martinez-Alday', 'Affiliation': 'Agencia de Investigación de la Sociedad Española de Cardiología, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ruiz-Granell', 'Affiliation': 'Agencia de Investigación de la Sociedad Española de Cardiología, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lacunza-Ruiz', 'Affiliation': 'Agencia de Investigación de la Sociedad Española de Cardiología, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Garcia-Civera', 'Affiliation': 'Agencia de Investigación de la Sociedad Española de Cardiología, Madrid, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Gutiérrez-Carretero', 'Affiliation': 'Department of Cardiology, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Sevilla. Av. Manuel Siurot, S/n, 41013 Sevilla, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romero-Garrido', 'Affiliation': 'Department of Cardiology, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Sevilla. Av. Manuel Siurot, S/n, 41013 Sevilla, Spain.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, University of Calgary 3330 Hospital Drive NW, Calgary, Alberta T2N 4N1 and Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz294']
1076,30943128,¡Activate Ya! Co-learning about school-based tobacco prevention and physical activity promotion in secondary school students in Uruguay.,"PURPOSE


¡Activate Ya! was a group-randomized controlled intervention trial aimed at developing and evaluating the impact of a school-based intervention on preventing cigarette smoking and promoting physical activity (PA) in secondary school students in Uruguay. Secondary aims were to evaluate the program's impact on students' smoking- and PA-related psychosocial risk and protective factors.
METHODS


Sixteen schools and  n  = 654 students participated in the study. The one-year intervention included a classroom-based curriculum, an afterschool program, activity breaks, and final showcase event. A self-administered questionnaire measured outcomes at three time points. Fixed effects regression models tested for differences in outcomes by study condition.
RESULTS


While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected. Past 7-day PA, measured by the PAQ-C, was significantly higher among intervention school students overall ( p  = .048) and for girls ( p  = .03) at posttest, and intervention girls reported significantly higher athletic identity PA competence, friend and teacher PA support at posttest, and PA enjoyment at follow-up ( p  < .05).
CONCLUSION


The positive short-term effects of ¡Activate Ya! on PA and related outcomes for girls support the utility of school-based health promotion in Uruguay. Additional research is needed to determine the most effective strategies to prevent tobacco use among students and promote PA among boys in this setting.",2020,"While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected.","['\n\n\nSixteen schools and n = 654 students participated in the study', 'secondary school students in Uruguay']","['school-based intervention', 'classroom-based curriculum, an afterschool program, activity breaks, and final showcase event', 'Activate Ya', 'Activate Ya! Co-learning about school-based tobacco prevention and physical activity promotion']","['cigarette smoking and promoting physical activity (PA', ""students' smoking- and PA-related psychosocial risk and protective factors"", 'athletic identity PA competence, friend and teacher PA support at posttest, and PA enjoyment', 'selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0042113', 'cui_str': 'Uruguay'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}]",654.0,0.0188797,"While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected.","[{'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Springer', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Harrell', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Martínez Gomensoro', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Traversa Fresco', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Florines', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Joowon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Perry', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bianco', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Estol', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}]",Global health promotion,['10.1177/1757975918813049']
1077,30657353,Choosing the right strategy based on individualized treatment effect predictions: combination versus sequential chemotherapy in patients with metastatic colorectal cancer.,"BACKGROUND


Translating results from randomized trials to individual patients is challenging, since treatment effects may vary due to heterogeneous prognostic characteristics. We aimed to demonstrate model development for individualized treatment effect predictions in cancer patients. We used data from two randomized trials that investigated sequential versus combination chemotherapy in unresectable metastatic colorectal cancer (mCRC) patients.
MATERIAL AND METHODS


We used data from 803 patients included in CAIRO for prediction model development and internal validation, and data from 1423 patients included in FOCUS for external validation. A Weibull model with pre-specified patient and tumour characteristics was developed for a prediction of gain in median overall survival (OS) by upfront combination versus sequential chemotherapy. Decision curve analysis with net benefit was used. A nomogram was built using logistic regression for estimating the probability of receiving second-line treatment after the first-line monochemotherapy.
RESULTS


Median-predicted gain in OS for the combination versus sequential chemotherapy was 2.3 months (IQR: -1.1 to 3.7 months). A predicted gain in favour of sequential chemotherapy was found in 231 patients (29%) and a predicted gain of >3 months for combination chemotherapy in 294 patients (37%). Patients with benefit from sequential chemotherapy had metachronous metastatic disease and a left-sided primary tumour. Decision curve analyses showed improvement in a net benefit for treating all patients according to prediction-based treatment compared to treating all patients with combination chemotherapy. Multiple characteristics were identified as prognostic variables which identify patients at risk of never receiving second-line treatment if treated with initial monochemotherapy. External validation showed good calibration with moderate discrimination in both models (C-index 0.66 and 0.65, respectively).
CONCLUSIONS


We successfully developed individualized prediction models including prognostic characteristics derived from randomized trials to estimate treatment effects in mCRC patients. In times where the heterogeneity of CRC becomes increasingly evident, such tools are an important step towards personalized treatment.",2019,Decision curve analyses showed improvement in a net benefit for treating all patients according to prediction-based treatment compared to treating all patients with combination chemotherapy.,"['803 patients included in CAIRO for prediction model development and internal validation, and data from 1423 patients included in FOCUS for external validation', 'patients with metastatic colorectal cancer', 'mCRC patients', 'Patients with benefit from sequential chemotherapy had metachronous metastatic disease and a left-sided primary tumour', 'unresectable metastatic colorectal cancer (mCRC) patients', 'cancer patients']","['sequential chemotherapy', 'sequential versus combination chemotherapy']",['Median-predicted gain in OS'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1423.0,0.115692,Decision curve analyses showed improvement in a net benefit for treating all patients according to prediction-based treatment compared to treating all patients with combination chemotherapy.,"[{'ForeName': 'Johannes J M', 'Initials': 'JJM', 'LastName': 'Kwakman', 'Affiliation': 'a Department of Medical Oncology , Amsterdam UMC, University of Amsterdam , Amsterdam , The Netherlands.'}, {'ForeName': 'Rob C M', 'Initials': 'RCM', 'LastName': 'van Kruijsdijk', 'Affiliation': 'b Department of Internal Medicine , University Medical Center Utrecht, Utrecht University , Utrecht , The Netherlands.'}, {'ForeName': 'Sjoerd G', 'Initials': 'SG', 'LastName': 'Elias', 'Affiliation': 'c Department of Epidemiology , Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Utrecht University , Utrecht , The Netherlands.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Seymour', 'Affiliation': 'd Department of Medical Oncology , The Leeds Teaching Hospitals, University of Leeds , Leeds , UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Meade', 'Affiliation': 'e Clinical Trials Unit at UCL , Institute of Clinical Trials and Methodology , London , UK.'}, {'ForeName': 'Frank L J', 'Initials': 'FLJ', 'LastName': 'Visseren', 'Affiliation': 'f Department of Vascular Medicine , University Medical Center Utrecht, Utrecht University , Utrecht , The Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'g Department of Medical Oncology , Amsterdam UMC, University of Amsterdam , Amsterdam , The Netherlands.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'h Department of Medical Oncology , University Medical Center Utrecht, Utrecht University , Utrecht , The Netherlands.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2018.1564840']
1078,30923094,Bortezomib-based induction followed by stem cell transplantation in light chain amyloidosis: results of the multicenter HOVON 104 trial.,"This prospective, multicenter, phase II study investigated the use of four cycles of bortezomib-dexamethasone induction treatment, followed by high-dose melphalan and autologous stem cell transplantation (SCT) in patients with newly diagnosed light chain amyloidosis. The aim of the study was to improve the hematologic complete remission (CR) rate 6 months after SCT from 30% to 50%. Fifty patients were enrolled and 72% had two or more organs involved. The overall hematologic response rate after induction treatment was 80% including 20% CR and 38% very good partial remissions (VGPR). Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients). Thirty-one patients received melphalan 200 mg/m 2  and four patients a reduced dose because of renal function impairment. There were no deaths related to the transplantation procedure. Hematologic responses improved at 6 months after SCT to 86% with 46% CR and 26% VGPR. However, due to the high treatment discontinuation rate before transplantation the primary endpoint of the study was not met and the CR rate in the intention-to-treat analysis was 32%. Organ responses continued to improve after SCT. We confirm the high efficacy of bortezomib-dexamethasone treatment in patients with AL amyloidosis. However, because of both treatment-related toxicity and disease characteristics, 30% of the patients could not proceed to SCT after induction treatment. ( Trial registered at Dutch Trial Register identifier NTR3220 ).",2019,Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients).,"['Fifty patients were enrolled and 72% had two or more organs involved', 'patients with AL amyloidosis', 'light chain amyloidosis', 'patients with newly diagnosed light chain amyloidosis']","['bortezomib-dexamethasone', 'Bortezomib-based induction followed by stem cell transplantation', 'melphalan', 'melphalan and autologous stem cell transplantation (SCT']","['overall hematologic response rate', 'renal function impairment', 'toxicity and disease-related organ damage and death', 'hematologic complete remission (CR) rate', 'CR rate', 'Hematologic responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0268381', 'cui_str': 'AL Amyloidosis'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",50.0,0.0357223,Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients).,"[{'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht Cancer Center, Utrecht, the Netherlands m.c.minnema@umcutrecht.nl.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Nasserinejad', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Bouke', 'Initials': 'B', 'LastName': 'Hazenberg', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University of Groningen Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Hegenbart', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, Heidelberg University, Amyloidosis Center, Heidelberg, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Vlummens', 'Affiliation': 'Department of Haematology, Ghent University, Gent, Belgium.'}, {'ForeName': 'Paula F', 'Initials': 'PF', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, HagaZiekenhuis, Den Haag, the Netherlands.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Marie Jose', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Department of Hematology, Academic Medical Center, Lymphoma and Myeloma Center, Amsterdam, the Netherlands.'}, {'ForeName': 'M Ron', 'Initials': 'MR', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Hematology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'de Waal', 'Affiliation': 'Department of Hematology, University of Groningen, Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam Cancer Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Lidwien', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'Department of Internal Medicine, Maxima Medisch Centrum, Eindhoven, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Koene', 'Affiliation': 'Department of Hematology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Hematology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schönland', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, Heidelberg University, Amyloidosis Center, Heidelberg, Germany.'}]",Haematologica,['10.3324/haematol.2018.213900']
1079,30896743,Dietary Calcium Intake and Bone Loss Over 6 Years in Osteopenic Postmenopausal Women.,"CONTEXT


Calcium intakes are commonly lower than the recommended levels, and increasing calcium intake is often recommended for bone health.
OBJECTIVE


To determine the relationship between dietary calcium intake and rate of bone loss in older postmenopausal women.
PARTICIPANTS


Analysis of observational data collected from a randomized controlled trial. Participants were osteopenic (hip T-scores between -1.0 and -2.5) women, aged >65 years, not receiving therapy for osteoporosis nor taking calcium supplements. Women from the total cohort (n = 1994) contributed data to the analysis of calcium intake and bone mineral density (BMD) at baseline, and women from the placebo group (n = 698) contributed data to the analysis of calcium intake and change in BMD. BMD and bone mineral content (BMC) of the spine, total hip, femoral neck, and total body were measured three times over 6 years.
RESULTS


Mean calcium intake was 886 mg/day. Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status, and past hormone replacement use. There was no relationship between bone loss and quintile of calcium intake at any site, with or without adjustment for covariables. Total body bone balance (i.e., change in BMC) was unrelated to an individuals' calcium intake (P = 0.99).
CONCLUSIONS


Postmenopausal bone loss is unrelated to dietary calcium intake. This suggests that strategies to increase calcium intake are unlikely to impact the prevalence of and morbidity from postmenopausal osteoporosis.",2019,"Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status and past hormone replacement use.","['women aged >65 years not receiving therapy for osteoporosis, nor taking calcium supplements', 'osteopenic postmenopausal women', 'older postmenopausal women', 'Participants were osteopenic (hip T-scores between -1.0 and -2.5']",['placebo'],"['bone loss', 'BMD and bone mineral content (BMC) of the spine, total hip, femoral neck and total body', 'Baseline BMDs', 'Dietary calcium intake and bone loss', 'calcium intake and bone mineral density (BMD', 'calcium intake and change in BMD', 'Total body bone balance', 'bone loss and quintile of calcium intake']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0006726', 'cui_str': 'Calcium, Dietary'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.119109,"Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status and past hormone replacement use.","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Bristow', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Mihov', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00111']
1080,30943777,Standard and accelerated corneal cross-linking long-term results: A randomized clinical trial.,"PURPOSE


To compare long-term results between accelerated and standard corneal cross-linking protocols in the treatment of progressive keratoconus and compare their effectiveness between central (cone in the central 3 mm) and peripheral (cone beyond 3 mm) cases.
METHODS


In this randomized clinical trial, we compared 31 eyes treated with accelerated corneal cross-linking (18 mW/cm 2 , 5 min) and 31 eyes treated with standard corneal cross-linking (3 mW/cm 2 , 30 min), 16 central and 11 peripheral keratoconus in each group. In this report, 4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count were evaluated.
RESULTS


Uncorrected distance visual acuity improvement was better with standard corneal cross-linking (0.19 ± 0.30 logMAR) than accelerated corneal cross-linking (0.08 ± 0.35 logMAR), but the intergroup difference was not statistically significant (p = 0.283). Cylinder and spherical equivalent significantly increased similarly in both groups. Among topographic indices, anterior Kmax-3 mm showed more reduction in standard corneal cross-linking than accelerated corneal cross-linking (1.35 ± 1.39 vs 0.36 ± 1.10 D, p = 0.011). Anterior Kmax-8 mm reduced by 1.50 ± 1.82 and 0.37 ± 1.58 D in the standard corneal cross-linking and accelerated corneal cross-linking groups, respectively (p = 0.029). Compared to 18-month results, none of the indices at 4 years showed any significant intergroup difference (all p > 0.05). In cases with peripheral keratoconus, changes in anterior Kmax-3 mm (+0.03 ± 0.66 vs -1.17 ± 1.15 D, p = 0.012) and anterior Kmax-8 mm (+0.43 ± 1.09 vs -1.57 ± 1.40 D, p = 0.003) were greater with standard corneal cross-linking. In central cases, no significant intergroup difference was observed.
CONCLUSION


At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery. These differences concerned cases of peripheral keratoconus, and the two protocols were similarly effective in central cases. Beyond the 18th month, the two protocols appeared to be similarly effective.",2020,"At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery.","['31 eyes treated with accelerated corneal cross-linking (18\u2009mW/cm 2 , 5\u2009min) and 31 eyes treated with']","['accelerated and standard corneal cross-linking protocols', 'standard corneal cross-linking']","['Uncorrected distance visual acuity improvement', 'Cylinder and spherical equivalent', '4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}]",,0.0477401,"At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery.","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hashemi', 'Affiliation': 'Noor Research Center for Ophthalmic Epidemiology, Noor Eye Hospital, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran.'}]",European journal of ophthalmology,['10.1177/1120672119839927']
1081,31707503,Effects of a home-exercise programme in childhood survivors of acute lymphoblastic leukaemia on physical fitness and physical functioning: results of a randomised clinical trial.,"PURPOSE


The aim of this study was to evaluate the effects of a home-exercise programme on physical fitness indicators and physical functioning after completion of chemotherapy in children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL).
METHODS


Twenty-four survivors of ALL were assigned to usual care (control group, n = 12, 11.0 ± 3.7 years) or to a home-exercise programme (intervention group, n = 12, 11.8 ± 4.3 years). Peak oxygen uptake (VO 2 peak ml/kg/min), minute ventilation (VE L/min), output of carbon dioxide (VCO 2  L/min), respiratory exchange ratio (RER), peak heart rate (beats/min), maximal load (W), VO 2  at anaerobic threshold (VO 2  at AT, ml/kg/min), pulse oxygen (PO 2  ml/beat), heart rate at anaerobic threshold (beats/min), handgrip test (pounds), flexibility (cm), Timed Up & Go test TUG (s), and Timed Up and Down Stairs test (TUDS s) were measured at baseline and over 16 weeks of intervention.
RESULTS


Adjusted mixed linear models revealed a significant group-time interaction + 6.7 (95% CI = 0.6-12.8 ml/kg/min; η 2  partial = 0.046, P = 0.035) for VO 2 peak. Similarly, changes in mean values were observed after the home-exercise programme compared with baseline for VE (L/min) - 8.8 (3.0) (P = 0.035), VCO 2  - 0.2 (0.08), (P = 0.041), maximal load (W) - 35.5 (12.8) (P = 0.024), TUDS (s) 0.8 (2.6) (P = 0.010), and TUG (s) 0.6 (0.1) (P = 0.001); however, the group-time interaction was not significant.
CONCLUSION


The home-exercise programme resulted in changes in measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test). This is an interesting and important study that surely adds to the current body of knowledge/literature on the safety of exercise interventions, especially in children with haematological cancer.",2020,"The home-exercise programme resulted in changes in measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test).","['children with haematological cancer', 'Twenty-four survivors of ALL were assigned to usual care (control group, n = 12, 11.0 ± 3.7 years) or to a', 'children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL', 'childhood survivors of acute lymphoblastic leukaemia on physical fitness and physical functioning']","['home-exercise programme (intervention', 'chemotherapy', 'home-exercise programme']","['physical fitness indicators and physical functioning', 'Peak oxygen uptake (VO 2 peak ml/kg/min), minute ventilation (VE L/min), output of carbon dioxide (VCO 2  L/min), respiratory exchange ratio (RER), peak heart rate (beats/min), maximal load (W), VO 2  at anaerobic threshold (VO 2  at AT, ml/kg/min), pulse oxygen (PO 2  ml/beat), heart rate at anaerobic threshold (beats/min), handgrip test (pounds), flexibility (cm), Timed Up & Go test TUG (s), and Timed Up and Down Stairs test (TUDS s', 'mean values', 'measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia, disease (disorder)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0456718', 'cui_str': 'mL/beat'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",24.0,0.112242,"The home-exercise programme resulted in changes in measures of VO 2 peak, VE, VCO 2 , and functional capacity during daily life activities (TUDS and TUG test).","[{'ForeName': 'Jahn Dubery', 'Initials': 'JD', 'LastName': 'Manchola-González', 'Affiliation': 'Physiotherapy Department, Universitat Inernacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Caritat', 'Initials': 'C', 'LastName': 'Bagur-Calafat', 'Affiliation': 'Physiotherapy Department, Universitat Inernacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Girabent-Farrés', 'Affiliation': 'Physiotherapy Department, Universitat Inernacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Josep Ricard', 'Initials': 'JR', 'LastName': 'Serra-Grima', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Roser Álvarez', 'Initials': 'RÁ', 'LastName': 'Pérez', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Manuel Vicente', 'Initials': 'MV', 'LastName': 'Garnacho-Castaño', 'Affiliation': 'Research group in physical activity, performance and health (GRI-AFIRS), School of Health Sciences, TecnoCampus-Pompeu Fabra University, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Badell', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed-Universidad Pública de Navarra (UPNA)-Complejo Hospitalario de Navarra (CHN), Instituto de Investigación Sanitaria de Navarra (IdiSNA), 31008, Pamplona, Navarra, Spain. robin640@hotmail.com.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05131-2']
1082,30659664,"Evaluating the effects of switching from dutasteride to tadalafil in benign prostatic hyperplasia patients with lower urinary tract symptoms: A randomized, open-label, multicenter study.",,2019,,['benign prostatic hyperplasia patients with lower urinary tract symptoms'],"['switching from dutasteride', 'tadalafil']",[],"[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]",[],,0.014301,,"[{'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Hatakeyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Narita', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yoneyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Ohyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13908']
1083,9340476,[Cost effectiveness of bisoprolol in heart failure. Economic evaluation of the Cardiac Insufficiency Bisoprolol Study (CIBIS) for Germany].,"BACKGROUND


The Cardiac Insufficiency Bisoprolol Study (CIBIS) demonstrates that, for patients with heart failure of different etiologies, the administration of the beta(1)-adrenoceptor blocker bisoprolol adjuvant to the standard therapy leads to a significant avoidance of hospital admissions.
PHARMACOECONOMIC EVALUATION


The results of the CIBIS were evaluated pharmacoeconomically for the Federal Republic of Germany, and were restricted to direct costs only. The costs of bisoprolol medication and in-patient treatment of heart failure were considered, the latter forming the major part of costs incurred.
CONCLUSION


Adjunctive therapy with bisoprolol is not only clinically beneficial to the patient with heart failure, but also economically advantageous.",1997,"The results of the CIBIS were evaluated pharmacoeconomically for the Federal Republic of Germany, and were restricted to direct costs only.","['Germany', 'heart failure', 'patients with heart failure of different etiologies']","['beta(1)-adrenoceptor blocker bisoprolol adjuvant', 'bisoprolol']",['costs of bisoprolol medication'],"[{'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015127', 'cui_str': 'causes'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}]",,0.0221624,"The results of the CIBIS were evaluated pharmacoeconomically for the Federal Republic of Germany, and were restricted to direct costs only.","[{'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Schädlich', 'Affiliation': 'InForMed, Gesselschaft für interdisziplinäre Forschung und Beratung im Gesundheitswesen, Hamburg.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Paschen', 'Affiliation': ''}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Brecht', 'Affiliation': ''}]","Medizinische Klinik (Munich, Germany : 1983)",[]
1084,31823527,"Pharmacokinetics, Pharmacodynamics, and Safety of a Single Escalating Dose and Repeated Doses of Rasagiline Transdermal Patch in Healthy Chinese Subjects.","A rasagiline transdermal patch can be used to offer continuous rasagiline to patients with Parkinson's disease who cannot take their usual oral medications. This was the first study to investigate the pharmacokinetics, pharmacodynamics, and safety of the rasagiline transdermal patch in healthy Chinese subjects. Thirty subjects were randomized to 3 groups with 10 subjects in each group. The 10 subjects of group 1 received a single 1-mg dose of rasagiline as a tablet; the 20 subjects of groups 2 and 3 received a single transdermal patch (48-hour patch-on period) containing 1.25 mg and 2.5 mg rasagiline, respectively. After a 2-week washout period, the subjects of group 1 were assigned to receive 1 mg of rasagiline tablets every 24 hours for 7 days, and the subjects of group 2 were assigned to receive 1.25-mg rasagiline transdermal patches (48-hour patch-on period) every 72 hours for 5 time periods. The absorption of rasagiline from the transdermal patch was significantly improved, although the peak plasma concentration was obviously reduced. There was slight accumulation of rasagiline dose after multiple administrations. Inhibition of platelet monoamine oxidase-B (MAO-B) activity was dose dependent. The 80% inhibition maintained for at least 48 hours after multiple-dose administration of 1 mg tablets, and for 72 hours after multiple-dose administration of 1.25 mg/48 h patch. Compared with rasagiline tablets, the transdermal patch had a prolonged duration of 80% inhibition and increased maximal inhibition of MAO-B activity. These characteristics permitted an interval of 3 days of dosing, which was convenient for patients to use.",2020,"Compared with rasagiline tablets, the transdermal patch had a prolonged duration of 80% inhibition and increased maximal inhibition of MAO-B activity.","['Healthy Chinese Subjects', 'Thirty subjects were randomized to 3 groups with 10 subjects in each group', ""patients with Parkinson's disease who cannot take their usual oral medications"", 'healthy Chinese subjects']","['single transdermal patch (48-hour patch-on period) containing 1.25 mg and 2.5\xa0mg rasagiline', 'single 1-mg dose of rasagiline', 'platelet monoamine oxidase-B', '1.25-mg rasagiline transdermal patches', 'rasagiline tablets', 'Rasagiline Transdermal Patch', 'rasagiline transdermal patch']","['absorption of rasagiline', 'peak plasma concentration', 'maximal inhibition of MAO-B activity', 'MAO-B) activity', 'pharmacokinetics, pharmacodynamics, and safety', 'Pharmacokinetics, Pharmacodynamics, and Safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0026456', 'cui_str': 'MAO-B'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0026456', 'cui_str': 'MAO-B'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0256371,"Compared with rasagiline tablets, the transdermal patch had a prolonged duration of 80% inhibition and increased maximal inhibition of MAO-B activity.","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Quanying', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Shunlin', 'Initials': 'S', 'LastName': 'Zong', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Chengzhe', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': ""Department of Pharmaceutics, Children's Hospital of Soochow University, Suzhou City, Jiangsu Province, China.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.761']
1085,30885760,"Comparison of a picosecond alexandrite laser versus a Q-switched alexandrite laser for the treatment of nevus of Ota: A randomized, split-lesion, controlled trial.","BACKGROUND


Novel picosecond lasers have been available for various pigmentary disorders. However, there are limited data directly comparing picosecond lasers and Q-switched lasers for treatment of nevus of Ota.
OBJECTIVE


To compare the efficacy and safety of a picosecond alexandrite laser (PSAL) with a Q-switched alexandrite laser (QSAL) for the treatment of nevus of Ota.
METHODS


Each lesion of 56 enrolled participants was split into 2 parts and randomly assigned to either the PSAL or QSAL treatment arm. Each lesion was treated in up to 6 sessions in 12-week intervals. Efficacy and safety were determined using blinded visual evaluation and self-report at each follow-up visit.
RESULTS


The PSAL arm achieved a significantly better clearance (5-point scale, PSAL 4.53 vs QSAL 4.0) with fewer sessions (PSAL 5.26 vs QSAL 5.87) and less severe pain (Visual Analog Scale, PSAL 5.61 vs QSAL 6.40). Patients were more satisfied with PSAL than QSAL (Likert scale, 4.5 vs 4.0). Occurrences of postinflammatory hyperpigmentation (PSAL 26% vs QSAL 34%) and hypopigmentation (PSAL 21% vs QSAL 47%) were also lower in PSAL than QSAL arm.
LIMITATIONS


Lack of objective assessments and outcome measures.
CONCLUSION


PSAL demonstrated better clinical results and fewer adverse events than QSAL for the treatment of nevus of Ota.",2020,"RESULTS


PSAL arm achieved a significantly better clearance (4.53 vs 4.0) with fewer sessions (5.26 vs 5.87) and less severe pain (5.61 vs 6.40).","['nevus of Ota', '56 participants enrolled was split into two parts']","['Q-switched alexandrite laser (QSAL', 'QSAL', 'picosecond alexandrite laser (PSAL', 'picosecond alexandrite laser versus a Q-switched alexandrite laser', 'PASL or QSAL']","['clearance', 'adverse events', 'Occurrences of post inflammatory hyperpigmentation', 'efficacy and safety', 'severe pain']","[{'cui': 'C0027961', 'cui_str': 'Nevus of Ota'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}]","[{'cui': 'C0392245', 'cui_str': 'Alexandrite Lasers'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",56.0,0.0503462,"RESULTS


PSAL arm achieved a significantly better clearance (4.53 vs 4.0) with fewer sessions (5.26 vs 5.87) and less severe pain (5.61 vs 6.40).","[{'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Mengli', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Qiuju', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Huizhen', 'Initials': 'H', 'LastName': 'Rong', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Gaorong', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Hualing', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China. Electronic address: ddlin@hotmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.03.016']
1086,31713310,Evaluation of a novel mesh-covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1-year results of the SCAFFOLD trial.,"OBJECTIVE


The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year.
BACKGROUND


SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population.
METHODS


The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates.
RESULTS


Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis.
CONCLUSIONS


Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).",2020,"Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population.
","['patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy', '312 patients enrolled and treated, 264 were eligible per protocol and evaluable for', 'patients at high risk for endarterectomy']","['novel mesh-covered stent', 'GORE® Carotid Stent (GCS']","['low rates of death/stroke/myocardial infarction', 'rate of DSMI', 'major adverse events', 'KM estimates of 1-year event probability', 'freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis', 'Kaplan-Meier (KM) estimates', 'proportion with ipsilateral stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C1322797', 'cui_str': 'Covered Stent'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}]",264.0,0.344714,"Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population.
","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Lankenau Heart Institute, Main Line Health, Wynnewood, Pennsylvania.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, SUNY University at Buffalo & Kaleida Health, Buffalo, New York.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Bacharach', 'Affiliation': 'North Central Heart Institute, Sioux Falls, South Dakota.'}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Wellmont CVA Heart and Vascular Institute, Kingsport, Tennessee.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Randall', 'Affiliation': 'W.L. Gore & Associates, Inc., Flagstaff, Arizona.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Siddiqui', 'Affiliation': 'Jacobs Institute, SUNY University at Buffalo & Kaleida Health, Buffalo, New York.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Schonholz', 'Affiliation': 'Division of Vascular & Interventional Radiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Alani', 'Affiliation': 'Covenant Healthcare System, Saginaw, Michigan.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Schneider', 'Affiliation': 'Hawaii Permanente Medical Group and Kaiser Foundation Hospital, Honolulu, Hawaii.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28586']
1087,30604373,Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.,"INTRODUCTION


Limitations in inflammatory bowel disease (IBD) care necessitate greater patient activation and self-efficacy, measures associated with positive health outcomes.
METHODS


We assessed change in patient activation and general self-efficacy from baseline to 12 months through our TELEmedicine for IBD trial, a multicenter, randomized controlled trial consisting of a web-based monitoring system that interacts with participants via text messaging. A total of 222 adults with IBD who had experienced an IBD flare within 2 years prior to the trial were randomized into either a control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W).
RESULTS


Changes in self-efficacy scores were not significantly different between control and experimental groups. Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03).
CONCLUSIONS


Use of remote monitoring did not improve self-efficacy or patient activation compared to routine care.",2020,"Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03).
",['222 adults with IBD who had experienced an IBD flare within 2\xa0years prior to the trial'],"['control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W', 'TELEmedicine']","['Patient activation scores', 'Patient Activation and Self-Efficacy', 'self-efficacy or patient activation', 'patient activation and general self-efficacy', 'self-efficacy scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",222.0,0.0406776,"Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03).
","[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Bilgrami', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Abutaleb', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Kenechukwu', 'Initials': 'K', 'LastName': 'Chudy-Onwugaje', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Langenberg', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Regueiro', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schwartz', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'J Kathleen', 'Initials': 'JK', 'LastName': 'Tracy', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Patil', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Quezada', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Russman', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Charlene C', 'Initials': 'CC', 'LastName': 'Quinn', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Guruprasad', 'Initials': 'G', 'LastName': 'Jambaulikar', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Dawn B', 'Initials': 'DB', 'LastName': 'Beaulieu', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Horst', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Raymond K', 'Initials': 'RK', 'LastName': 'Cross', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA. rcross@som.umaryland.edu.'}]",Digestive diseases and sciences,['10.1007/s10620-018-5433-5']
1088,31708447,"A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial.","BACKGROUND


Patients with recent stroke or transient ischaemic attack are at high risk for a further vascular event, possibly leading to permanent disability or death. Although evidence-based treatments for secondary prevention are available, many patients do not achieve recommended behavioural modifications and pharmaceutical prevention targets in the long-term. We aimed to investigate whether a support programme for enhanced secondary prevention can reduce the frequency of recurrent vascular events.
METHODS


INSPiRE-TMS was an open-label, multicentre, international randomised controlled trial done at seven German hospitals with acute stroke units and a Danish stroke centre. Patients with non-disabling stroke or transient ischaemic attack within 2 weeks from study enrolment and at least one modifiable risk factor (ie, arterial hypertension, diabetes, atrial fibrillation, or smoking) were included. Computerised randomisation was used to allocate patients (1:1) either to the support programme in addition to conventional care or to conventional care alone. The support programme used feedback and motivational interviewing strategies with eight outpatient visits over 2 years aiming to improve adherence to secondary prevention targets. The primary outcome was the composite of major vascular events consisting of stroke, acute coronary syndrome, and vascular death, assessed in the intention-to-treat population (all patients who underwent randomisation, did not withdraw study participation, and had at least one follow-up). Outcomes were assessed at annual follow-ups using time-to-first-event analysis. All-cause death was monitored as a safety outcome. This trial is registered with ClinicalTrials.gov, NCT01586702.
FINDINGS


From Aug 22, 2011, to Oct 30, 2017, we enrolled 2098 patients. Of those, 1048 (50·0%) were randomly assigned to the support programme group and 1050 (50·0%) patients were assigned to the conventional care group. 1030 (98·3%) patients in the support group and 1042 (99·2%) patients in the conventional care group were included in the intention-to-treat analysis. The mean age of analysed participants was 67·4 years and 700 (34%) were women. After a mean follow-up of 3·6 years, the primary outcome of major vascular events had occurred in 163 (15·8%) of 1030 patients of the support programme group and in 175 (16·8%) of 1042 patients of the conventional care group (hazard ratio [HR] 0·92, 95% CI 0·75-1·14). Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17). More patients in the support programme group achieved secondary prevention targets (eg, in 1-year-follow-up 52% vs 42% [p<0·0001] for blood pressure, 62% vs 54% [p=0·0010] for LDL, 33% vs 19% [p<0·0001] for physical activity, and 51% vs 34% [p=0·0010] for smoking cessation).
INTERPRETATION


Provision of an intensified secondary prevention programme in patients with non-disabling stroke or transient ischaemic attack was associated with improved achievement of secondary prevention targets but did not lead to a significantly lower rate of major vascular events. Further research is needed to investigate the effects of support programmes in selected patients who do not achieve secondary prevention targets soon after discharge.
FUNDING


German Federal Ministry of Education and Research, Pfizer, and German Stroke Foundation.",2020,"Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17).","['From Aug 22, 2011, to Oct 30, 2017, we enrolled 2098 patients', 'seven German hospitals with acute stroke units and a Danish stroke centre', '1030 (98·3%) patients in the support group and 1042 (99·2%) patients in the conventional care group were included in the intention-to-treat analysis', 'Patients with recent stroke or transient ischaemic attack', 'The mean age of analysed participants was 67·4 years and 700 (34%) were women', 'Patients with non-disabling stroke or transient ischaemic attack within 2 weeks from study enrolment and at least one modifiable risk factor (ie, arterial hypertension, diabetes, atrial fibrillation, or smoking) were included', 'patients with transient ischaemic attack and minor stroke (INSPiRE-TMS', 'selected patients who do not achieve secondary prevention targets soon after discharge', 'patients with non-disabling stroke or transient ischaemic attack']","['support programme in addition to conventional care or to conventional care alone', 'conventional care group']","['major vascular events', 'blood pressure', 'secondary prevention targets', 'physical activity', 'composite of major vascular events consisting of stroke, acute coronary syndrome, and vascular death, assessed in the intention-to-treat population', 'cause death', 'Total major vascular event numbers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",2098.0,0.159218,"Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Laumeier', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ihl', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Steinicke', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ferse', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Centre for Cardiovascular Research, Berlin, Germany; German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Grau', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Sidsel', 'Initials': 'S', 'LastName': 'Hastrup', 'Affiliation': 'The Danish Stroke Centre, Neurology, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Poppert', 'Affiliation': 'Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Palm', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schoene', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Seifert', 'Affiliation': 'Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Farid I', 'Initials': 'FI', 'LastName': 'Kandil', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Institute of Computational Neuroscience, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Weber', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'von Weitzel-Mudersbach', 'Affiliation': 'The Danish Stroke Centre, Neurology, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Martin L J', 'Initials': 'MLJ', 'LastName': 'Wimmer', 'Affiliation': 'Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, Munich, Germany.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': 'Department of Neurology and Neurosurgery and Julius Center, University Medical Center Utrecht and Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Centre, Bichat Hospital, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Jacoba P', 'Initials': 'JP', 'LastName': 'Greving', 'Affiliation': 'Department of Neurology and Neurosurgery and Julius Center, University Medical Center Utrecht and Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Busse', 'Affiliation': 'German Stroke Society, Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Köhler', 'Affiliation': 'Medical Department, Division of Cardiology and Angiology, Campus Charité Mitte, Centre for Cardiovascular Telemedicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marx', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Heinrich J', 'Initials': 'HJ', 'LastName': 'Audebert', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address: Heinrich.audebert@charite.de.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30369-2']
1089,30589514,"Prospective, double-blind, randomized clinical trial comparing an ERAS pathway with ketorolac and pregabalin versus standard of care plus placebo during live donor nephrectomy for kidney transplant.","Opioid exposure is a concern after live donation for kidney transplant. We theorized that an enhanced recovery after surgery pathway (ERAS) using pregabalin preoperatively to desensitize nerves followed by the nonsteroidal anti-inflammatory drug ketorolac, during and after surgery, can control pain, thus requiring less perioperative narcotics. The aim of this study was to determine if the use of a nonopioid analgesic ERAS protocol for donor nephrectomies could decrease the use of narcotics without an increase in complications compared with standard of care (SOC). This is a single-center, prospective, double-blind, randomized clinical trial involving a total of 62 patients undergoing nephrectomy for live donor kidney transplant. Length of hospital stay (LOS) was significantly reduced by 10% in the ERAS group versus the SOC-plus-placebo group. Morphine dose equivalents were significantly reduced by 40% in the study group versus the SOC-plus-placebo group. The use of this nonopioid analgesic ERAS pathway for donor nephrectomies decreased the use of narcotics without an increase in complications compared with SOC. There was significantly reduced LOS and less narcotic use in the study group versus the SOC-plus-placebo group. (ClinicalTrials.gov registration number: NCT03669081).",2019,There was significantly reduced LOS and less narcotic use in the study group versus the SOC-plus-placebo group.,"['live donor nephrectomy for kidney transplant', '62 patients undergoing nephrectomy for live donor kidney transplant']","['SOC-plus-placebo', 'ERAS', 'nonopioid analgesic ERAS protocol', 'ERAS pathway with ketorolac and pregabalin versus standard of care plus placebo', 'Morphine']","['Length of hospital stay (LOS', 'LOS']","[{'cui': 'C0401187', 'cui_str': 'Donation of kidney'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242937', 'cui_str': 'Non-Opioid Analgesics'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",62.0,0.515702,There was significantly reduced LOS and less narcotic use in the study group versus the SOC-plus-placebo group.,"[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Campsen', 'Affiliation': 'Department of Surgery, Division of Transplantation and Advanced Hepatobiliary Surgery, Salt Lake City, Utah.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Call', 'Affiliation': 'Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Chelsea McCarty', 'Initials': 'CM', 'LastName': 'Allen', 'Affiliation': 'Department of Internal Medicine, Division of Epidemiology, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Angela P', 'Initials': 'AP', 'LastName': 'Presson', 'Affiliation': 'Department of Internal Medicine, Division of Epidemiology, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Eryberto', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Department of Surgery, Division of Transplantation and Advanced Hepatobiliary Surgery, Salt Lake City, Utah.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rofaiel', 'Affiliation': 'Department of Surgery, Division of Transplantation and Advanced Hepatobiliary Surgery, Salt Lake City, Utah.'}, {'ForeName': 'Robin D', 'Initials': 'RD', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Division of Transplantation and Advanced Hepatobiliary Surgery, Salt Lake City, Utah.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15242']
1090,29659963,Saturated Fats from Butter but Not from Cheese Increase HDL-Mediated Cholesterol Efflux Capacity from J774 Macrophages in Men and Women with Abdominal Obesity.,"Background


Recent evidence suggests that the association between dietary saturated fatty acids (SFAs) and coronary artery disease risk varies according to food sources. How SFAs from butter and cheese influence HDL-mediated cholesterol efflux capacity (CEC), a key process in reverse cholesterol transport, is currently unknown.
Objective


In a predefined secondary analysis of a previously published trial, we have examined how diets rich in SFAs from either cheese or butter influence HDL-mediated CEC, compared with diets rich in either monounsaturated fatty acids (MUFAs) or polyunsaturated fatty acids (PUFAs).
Methods


In a randomized crossover controlled consumption trial, 46 men and women with abdominal obesity consumed 5 isocaloric diets, each for 4 wk. Two diets were rich in SFAs either from cheese (CHEESE) or butter (BUTTER) [12.4-12.6% of energy (%E) as SFAs, 32%E as fat, 52%E as carbohydrates]. In 2 other diets, SFAs (5.8%E) were replaced with either MUFAs from refined olive oil (MUFA) or PUFAs from corn oil (PUFA). Finally, a lower fat and carbohydrate diet was used as a control (5.8%E as SFAs, 25.0%E as fat, 59%E as carbohydrates; CHO). Post-diet HDL-mediated CEC was determined ex vivo using radiolabelled J774 macrophages incubated with apolipoprotein B-depleted serum from the participants.
Results


Mean (±SD) age was 41.4 ± 14.2 y, and waist circumference was 107.6 ± 11.5 cm in men and 94.3 ± 12.4 cm in women. BUTTER and MUFA increased HDL-mediated CEC compared with CHEESE (+4.3%, P = 0.026 and +4.7%, P = 0.031, respectively). Exploring the significant diet × sex interaction (P = 0.044) revealed that the increase in HDL-mediated CEC after BUTTER compared with CHEESE was significant among men (+6.0%, P = 0.047) but not women (+2.9%, P = 0.19), whereas the increase after MUFA compared with CHEESE was significant among women (+9.1%, P = 0.008) but not men (-0.6%, P = 0.99).
Conclusion


These results provide evidence of a food matrix effect modulating the impact of dairy SFAs on HDL-mediated CEC with potential sex-related differences that deserve further investigation. This trial was registered at clinicaltrials.gov as NCT02106208.",2018,"BUTTER and MUFA increased HDL-mediated CEC compared with CHEESE (+4.3%, P = 0.026 and +4.7%, P = 0.031, respectively).","['Mean (±SD) age was 41.4\xa0±\xa014.2 y, and waist circumference was 107.6\xa0±\xa011.5 cm in men and 94.3\xa0±\xa012.4 cm in women', 'Men and Women with Abdominal Obesity', '46 men and women with abdominal obesity consumed 5 isocaloric diets, each for 4 wk']","['MUFAs from refined olive oil (MUFA) or PUFAs from corn oil (PUFA', 'Saturated Fats from Butter', 'monounsaturated fatty acids (MUFAs) or polyunsaturated fatty acids (PUFAs']",['HDL-mediated CEC'],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517543', 'cui_str': '12.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus (organism)'}]",46.0,0.0601803,"BUTTER and MUFA increased HDL-mediated CEC compared with CHEESE (+4.3%, P = 0.026 and +4.7%, P = 0.031, respectively).","[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Brassard', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Benoît J', 'Initials': 'BJ', 'LastName': 'Arsenault', 'Affiliation': ""Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': ""Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bernic', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Maude', 'Initials': 'M', 'LastName': 'Tessier-Grenier', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Talbot', 'Affiliation': 'Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Asztalos', 'Affiliation': 'Cardiovascular Nutrition Laboratory, Human Nutrition Research Center on Aging, Tufts University, Boston, MA.'}, {'ForeName': 'Peter J H', 'Initials': 'PJH', 'LastName': 'Jones', 'Affiliation': 'Richardson Centre for Functional Foods and Nutraceuticals (RCFFN), University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Couture', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Lamarche', 'Affiliation': ""Institute of Nutrition and Functional Foods (INAF), School of Nutrition, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) and Department of Medicine, Department of Social and Preventive Medicine, CHU de Quebec Research Center, and Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, Canada.""}]",The Journal of nutrition,['10.1093/jn/nxy014']
1091,30882160,Treatment Satisfaction with Flexible-dose Fesoterodine in Patients with Overactive Bladder who were Dissatisfied with Previous Anticholinergic Therapy: A Multicenter Single-Arm Clinical Study.,"PURPOSE


We investigated treatment satisfaction with flexible-dose fesoterodine in patients with overactive bladder (OAB) who were dissatisfied with previous anticholinergic therapy.
MATERIALS AND METHODS


The subjects were prescribed fesoterodine 4 mg for 4 weeks and fesoterodine 4 mg or 8 mg for another 8 weeks. The primary end point of this study was patients' satisfaction after 12 weeks of fesoterodine treatment on a five-point Likert scale. Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
RESULTS


Overall, 84 patients were assigned to the treatment group in this study and 63 patients completed the 12-week treatment course. A final fesoterodine dose of 4 mg and 8 mg was used by 45 (71.4%) and 18 (28.6%) patients, respectively. The satisfaction and dissatisfaction rates at 12 weeks were 69.9% and 14.2%, respectively. Mean changes in the daytime micturitions (9.73 ± 4.72 vs. 7.76 ± 2.86), urgency episodes (7.73 ± 5.68 vs. 3.71 ± 4.09), and nocturnal micturitions (2.13 ± 1.36 vs. 1.68 ± 1.12) in 24 hours improved significantly with flexible-dose fesoterodine treatment (P < .05). Most adverse events were mild and none were severe.
CONCLUSION


The flexible dose fesoterodine represents an alternative treatment modality in patients with OAB who are dissatisfied with previous anticholinergic therapy in Korea.",2020,"Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
","['patients with overactive bladder (OAB) who were dissatisfied with previous anticholinergic therapy', 'patients with OAB who are dissatisfied with previous anticholinergic therapy in Korea', '84 patients', 'Patients with Overactive Bladder who were Dissatisfied with Previous Anticholinergic Therapy']","['fesoterodine', 'Flexible-dose Fesoterodine', 'flexible-dose fesoterodine']","['change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment', 'satisfaction and dissatisfaction rates', 'urgency episodes', 'five-point Likert scale', 'nocturnal micturitions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",84.0,0.045367,"Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
","[{'ForeName': 'Jin Bong', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea. c-sparrow@hanmail.net.""}, {'ForeName': 'Kang Jun', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}, {'ForeName': 'Won Hee', 'Initials': 'WH', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Inha University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dong Hwan', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ""Department of Urology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.""}, {'ForeName': 'Young-Ho', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.'}, {'ForeName': 'In Rae', 'Initials': 'IR', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Ilsanpaik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Urology, School of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, National Health Insurance Service, Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}]",Urology journal,['10.22037/uj.v0i0.4650']
1092,30882163,Effects of Isothermic Irrigation on Core Body Temperature During Endoscopic Urethral Stone Treatment Surgery Under Spinal Anesthesia: A Randomized Controlled Trial.,"Purpose? Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery. The current study is designed to study the effect of isothermic hydration on core temperature in patients scheduled for endoscopic urethral stone treatment surgery under spinal anesthesia. Materials and Methods? Sixty patients allocated randomly into two groups. In GroupW (n = 30) irrigation fluid at 37°C was used whereas at room temperature in GroupRT (n = 30). Spinal anesthesia was performed at L3-L4 interspace with 15mg of hyperbaric bupivacaine. Core temperature, shivering, and hemodynamic parameters were measured every minute until 10th minute and five minute intervals until the end of operation. Shivering and surgeon comfort was also recorded. The primary outcome was the core temperature at the end of surgery. Frequencies, means, standard deviations, percentages, chi-square tests, independent samples t-test, and Mann Whitney U tests were used where eligible for the statistical analysis.Results? Baseline core temperature was 36.6 ± 0.4°C in GroupW and 36.6 ± 0.5°C in GroupRT (P = .097) which decreased to 36.0 ± 0.5°C and 35.2 ± 0.7°C respectively (P = .018) at the end of operation.  Shivering was observed in 36.7% (n = 11) in GroupRT and 6.7% (n = 2) in GroupW (P = .012). Hemodynamic parameter changes and demographic data were not significant between groups.Conclusion? Isothermic irrigation decreases both the reduction in core temperature and the incidence of shivering while increasing the surgeon comfort.",2020,Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery.,"['patients undergoing endoscopic urethral stone treatment surgery', 'Sixty patients allocated randomly into two groups', 'patients undergoing transurethral resection of prostate gland', 'patients scheduled for endoscopic urethral stone treatment surgery under spinal anesthesia']","['Isothermic irrigation', 'Spinal anesthesia was performed at L3-L4 interspace with 15mg of hyperbaric bupivacaine', 'Endoscopic Urethral Stone Treatment Surgery Under Spinal Anesthesia', 'isothermic hydration', 'Isothermic Irrigation']","['Shivering', 'core temperature at the end of surgery', 'Core Body Temperature', 'Shivering and surgeon comfort', 'Core temperature, shivering, and hemodynamic parameters', 'Hemodynamic parameter changes and demographic data', 'Frequencies, means, standard deviations, percentages, chi-square tests, independent samples t-test, and Mann Whitney U tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162301', 'cui_str': 'Calculus in urethra (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0162301', 'cui_str': 'Calculus in urethra (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}]","[{'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}]",60.0,0.0455054,Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery.,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Canturk', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey. drmcanturk@gmail.com.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Hakki', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Kocaoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4524']
1093,30770334,Effect of different surface treatment on the shear bond strength of metal brackets to bleached and desensitized enamel.,"INTRODUCTION


The aim of this study was to determine the effect of bleaching and desensitizing on shear bond strength (SBS) of metal brackets to enamel.
METHODS


One hundred extracted human premolar were randomly assigned to 5 groups of 20. In the first group (control), no bleaching or desensitizing agent was used. Groups 2 to 5 were bleached with 37.5% hydrogen peroxide and desensitized with 6.0% potassium nitrate. Surface treatment comprised of etching for 15seconds in groups 1, 2 and 3, Er:yag laser irradiation and etching in group 4 and sandblasting and etching in group 5. Premolar brackets were bonded with Transbond XT and cured for 20seconds and the SBS was tested using a universal testing machine. Adhesive remnant index (ARI) score was used to record the mode of bond failure.
RESULTS


No significant difference was found between the mean SBS (MPa) in groups 1(15.22), 4(14.02), and 5(12.62). SBS in group 4 was significantly higher than group 2 (8.15) (P<0.001). Also, SBS in groups 2 (P<0.001) and 3(11.74) (P=0.012) were significantly lower than group 1. An increased frequency of ARI score of 2 and 3 was observed in groups 1, 4 and 5.
CONCLUSIONS


Bleaching plus desensitizing significantly decreased the SBS of orthodontic brackets. Delaying the bonding procedure for at least 2 weeks or alternative surface treatment methods such as combined laser and acid etching or combined sand blasting and acid etching can improve the SBS.",2019,SBS in group 4 was significantly higher than group 2 (8.15) (P<0.001).,"['One hundred', 'extracted human premolar', 'metal brackets to bleached and desensitized enamel']","['laser irradiation and etching', 'bleaching and desensitizing', 'Transbond XT', 'hydrogen peroxide and desensitized with 6.0% potassium nitrate']","['frequency of ARI score', 'mean SBS (MPa', 'SBS of orthodontic brackets', 'Adhesive remnant index (ARI) score', 'SBS', 'shear bond strength (SBS']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C1312066', 'cui_str': 'Transbond XT'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085428', 'cui_str': 'Dental Braces'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}]",100.0,0.0222809,SBS in group 4 was significantly higher than group 2 (8.15) (P<0.001).,"[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Zarif Najafi', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Rafaat', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Dental Material Department and Biomaterials Research Center, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Pakshir', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Amin', 'Initials': 'MA', 'LastName': 'Tavakkoli', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: tavakkolident@gmail.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Torkan', 'Affiliation': 'Department of orthodontics, University of Washington, Seattle, WA, USA.'}]",International orthodontics,['10.1016/j.ortho.2019.01.008']
1094,30857952,"To Cement or Not? Five-Year Results of a Prospective, Randomized Study Comparing Cemented vs Cementless Total Knee Arthroplasty.","BACKGROUND


The optimal mode of fixation in total knee arthroplasty is a continuing subject of debate.
METHODS


Previously, we reported 2-year results for this prospective, randomized trial. Knee Society Scores, Oxford scores, and pain visual analog scales were collected pre-operatively and post-operatively. Minimum 5-year follow-up has been obtained with radiographic analysis for 85 patients.
RESULTS


Mean Knee Society Scores and Oxford scores and patient-reported outcomes were similar in both groups. Each group had 1 additional revision, but neither was related to implant fixation. Survivorship with revision as an endpoint was equivalent (95.9% and 95.3%, P = .98). There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION


Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up. Updates are planned at 10 and 15-year intervals to observe long-term modes of failure between these 2 methods of fixation.",2019,"There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION


Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up.",['85 patients'],[],"['radiolucencies', 'Knee Society Scores, Oxford scores, and pain visual analog scales', 'Mean Knee Society Scores and Oxford scores and patient-reported outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",85.0,0.0868731,"There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION


Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up.","[{'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Fricka', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McAsey', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}, {'ForeName': 'Supatra', 'Initials': 'S', 'LastName': 'Sritulanondha', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.024']
1095,30882284,Start-up propulsion biomechanics changes with fatiguing activity in persons with spinal cord injury.,"Objective:  Shoulder pathology is a common condition in wheelchair users that can considerably impact quality of life. Shoulder muscles are prone to fatigue, but it is unclear how fatigue affects start-up propulsion biomechanics. This study determines acute changes in start-up wheelchair propulsion biomechanics at the end of a fatiguing propulsion protocol.  Design:  Quasi-experimental one-group pretest-postest design.  Setting:  Biomechanics laboratory . Participants:  Twenty-six wheelchair users with spinal cord injury (age: 35.5 ± 9.8 years, sex: 73% males and 73% with a paraplegia).  Interventions:  Protocol of 15 min including maximum voluntary propulsion, right- and left turns, full stops, start-up propulsion, and rests.  Outcome measures:  Maximum resultant force, maximum rate of rise of applied force, mean velocity, mean fraction of effective force, and mean contact time at the beginning and end of the protocol during start-up propulsion.  Results:  There was a significant reduction in maximum resultant force (P < 0.001) and mean velocity (P < 0.001) at the end of the protocol. Also, contact time was reduced in the first stroke of start-up propulsion (P < 0.001). Finally, propelling with a shorter contact time was associated with a greater reduction in performance (maximum velocity) at the end of the protocol.  Conclusion:  There are clear changes in overground propulsion biomechanics at the end of a fatiguing propulsion protocol. While reduced forces could protect the shoulder, these reduced forces come with shorter contact times and lower velocity. Investigating changes in start-up propulsion biomechanics with fatigue could provide insight into injury risk.",2020,"Also, contact time was reduced in the first stroke of start-up propulsion (P < 0.001).","['persons with spinal cord injury', 'Twenty-six wheelchair users with spinal cord injury (age: 35.5\u2009±\u20099.8 years, sex: 73% males and 73% with a paraplegia']","['Protocol of 15 min including maximum voluntary propulsion, right- and left turns, full stops, start-up propulsion, and rests']","['mean velocity', 'performance (maximum velocity', 'contact time', 'maximum resultant force', 'Maximum resultant force, maximum rate of rise of applied force, mean velocity, mean fraction of effective force, and mean contact time at the beginning and end of the protocol during start-up propulsion']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]",,0.0635597,"Also, contact time was reduced in the first stroke of start-up propulsion (P < 0.001).","[{'ForeName': 'Fransiska M', 'Initials': 'FM', 'LastName': 'Bossuyt', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Hogaboom', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Worobey', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Koontz', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ursina', 'Initials': 'U', 'LastName': 'Arnet', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Boninger', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2019.1582603']
1096,30873731,Driving change: A partnership study protocol using shared emergency department data to reduce alcohol-related harm.,"BACKGROUND


Sharing anonymised ED data with community agencies to reduce alcohol-related injury and assaults has been found effective in the UK. This protocol document outlines the design of an Australian multi-site trial using shared, anonymised ED data to reduce alcohol-related harm.
DESIGN AND METHOD


Nine hospitals will participate in a 36 month stepped-wedge cluster randomised trial. After a 9 month baseline period, EDs will be randomised in five groups, clustered on geographic proximity, to commence the intervention at 3 monthly intervals. 'Last-drinks' data regarding alcohol use in the preceding 12 h, typical alcohol consumption amount, and location of alcohol purchase and consumption, are to be prospectively collected by ED triage nurses and clinicians at all nine EDs as a part of standard clinical process. Brief information flyers will be delivered to all ED patients who self-report risky alcohol consumption. Public Health Interventions to be conducted are: (i) information sharing with venues (via letter), and (ii) with police and other community agencies, and (iii) the option for public release of 'Top 5' venue lists.
OUTCOMES


Primary outcomes will be: (i) the number and proportion of ED attendances among patients reporting recent alcohol use; and (ii) the number and proportion of ED attendances during high-alcohol hours (Friday and Saturday nights, 20.00-06.00 hours) assigned an injury diagnosis. Process measures will assess logistical and feasibility concerns, and clinical impacts of implementing this systems-change model in an Australian context. An economic cost-benefit analysis will evaluate the economic impact, or return on investment.",2019,"BACKGROUND


Sharing anonymised ED data with community agencies to reduce alcohol-related injury and assaults has been found effective in the UK.","['ED patients who self-report risky alcohol consumption', 'Nine hospitals will participate in a 36 month stepped-wedge cluster randomised trial']",[],"[' (i) the number and proportion of ED attendances among patients reporting recent alcohol use; and (ii) the number and proportion of ED attendances during high-alcohol hours (Friday and Saturday nights, 20.00-06.00 hours) assigned an injury diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0585029', 'cui_str': 'Friday (qualifier value)'}, {'cui': 'C0585030', 'cui_str': 'Saturday (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",9.0,0.0606412,"BACKGROUND


Sharing anonymised ED data with community agencies to reduce alcohol-related injury and assaults has been found effective in the UK.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Miller', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Droste', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Egerton-Warburton', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Caldicott', 'Affiliation': 'Calvary Health Care, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Gordian', 'Initials': 'G', 'LastName': 'Fulde', 'Affiliation': ""St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Ezard', 'Affiliation': ""St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Preisz', 'Affiliation': ""St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walby', 'Affiliation': ""St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lloyd-Jones', 'Affiliation': ""St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Stella', 'Affiliation': 'Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sheridan', 'Affiliation': 'Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Baker', 'Affiliation': 'Southwest Health Care, Warrnambool, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'The Canberra Hospital and Health Service, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shakeshaft', 'Affiliation': 'National Drug and Alcohol Research Centre, The University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alys', 'Initials': 'A', 'LastName': 'Havard', 'Affiliation': 'Centre for Big Data Research in Health, The University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Bowe', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Petra K', 'Initials': 'PK', 'LastName': 'Staiger', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'National Centre for Epidemiology and Population Health, The Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Doran', 'Affiliation': 'Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Coomber', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hyder', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Barker', 'Affiliation': 'Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shepherd', 'Affiliation': 'Crime and Security Research Institute, Cardiff University, Cardiff, UK.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13266']
1097,31704740,Multicenter Randomized Controlled Trial of Vitamin K Antagonist Replacement by Rivaroxaban with or without Vitamin K2 in Hemodialysis Patients with Atrial Fibrillation: the Valkyrie Study.,"BACKGROUND


Vitamin K antagonists (VKAs), although commonly used to reduce thromboembolic risk in atrial fibrillation, have been incriminated as probable cause of accelerated vascular calcification (VC) in patients on hemodialysis. Functional vitamin K deficiency may further contribute to their susceptibility for VC. We investigated the effect of vitamin K status on VC progression in 132 patients on hemodialysis with atrial fibrillation treated with VKAs or qualifying for anticoagulation.
METHODS


Patients were randomized to VKAs with target INR 2-3, rivaroxaban 10 mg daily, or rivaroxaban 10 mg daily plus vitamin K2 2000  µ g thrice weekly during 18 months. Systemic dp-ucMGP levels were quantified to assess vascular vitamin K status. Cardiac and thoracic aorta calcium scores and pulse wave velocity were measured to evaluate VC progression.
RESULTS


Baseline dp-ucMGP was severely elevated in all groups. Initiation or continuation of VKAs further increased dp-ucMGP, whereas levels decreased in the rivaroxaban group and to a larger extent in the rivaroxaban+vitamin K2 group, but remained nevertheless elevated. Changes in coronary artery, thoracic aorta, and cardiac valve calcium scores and pulse wave velocity were not significantly different among the treatment arms. All cause death, stroke, and cardiovascular event rates were similar between the groups. Bleeding outcomes were not significantly different, except for a lower number of life-threatening and major bleeding episodes in the rivaroxaban arms versus the VKA arm.
CONCLUSIONS


Withdrawal of VKAs and high-dose vitamin K2 improve vitamin K status in patients on hemodialysis, but have no significant favorable effect on VC progression. Severe bleeding complications may be lower with rivaroxaban than with VKAs.",2020,"Bleeding outcomes were not significantly different, except for a lower number of life-threatening and major bleeding episodes in the rivaroxaban arms versus the VKA arm.
","['Patients', 'patients on hemodialysis', 'Hemodialysis Patients with Atrial Fibrillation', '132 patients on hemodialysis with atrial fibrillation treated with VKAs or qualifying for anticoagulation']","['rivaroxaban', 'vitamin K status', 'rivaroxaban 10 mg daily, or rivaroxaban 10 mg daily plus vitamin K2 2000', 'Vitamin K antagonists (VKAs', 'Rivaroxaban with or without Vitamin K2', 'Vitamin K Antagonist Replacement']","['VC progression', 'Initiation or continuation of VKAs further increased dp-ucMGP', 'Severe bleeding complications', 'life-threatening and major bleeding episodes', 'All cause death, stroke, and cardiovascular event rates', 'vitamin K status', 'Changes in coronary artery, thoracic aorta, and cardiac valve calcium scores and pulse wave velocity', 'Bleeding outcomes', 'Cardiac and thoracic aorta calcium scores and pulse wave velocity', 'Systemic dp-ucMGP levels', 'vascular vitamin K status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3162458', 'cui_str': 'rivaroxaban 10 MG [Xarelto]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1522460', 'cui_str': 'Thoracic aorta structure (body structure)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",132.0,0.173215,"Bleeding outcomes were not significantly different, except for a lower number of life-threatening and major bleeding episodes in the rivaroxaban arms versus the VKA arm.
","[{'ForeName': 'An S', 'Initials': 'AS', 'LastName': 'De Vriese', 'Affiliation': 'Division of Nephrology and Infectious Diseases and an.devriese@azsintjan.be.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Caluwé', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Pyfferoen', 'Affiliation': 'Department of Medical Imaging, AZ Sint-Jan Brugge, Brugge, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Bacquer', 'Affiliation': 'Public Health, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Delanote', 'Affiliation': 'Department of Medical Imaging, AZ Sint-Jan Brugge, Brugge, Belgium.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'De Surgeloose', 'Affiliation': 'Department of Medical Imaging, ZNA Middelheim, Antwerp, Belgium; and.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Van Hoenacker', 'Affiliation': 'Department of Medical Imaging, Onze Lieve Vrouw Hospital, Aalst, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Van Vlem', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Verbeke', 'Affiliation': 'Division of Nephrology, University Hospital, Ghent, Belgium.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019060579']
1098,30829142,Counselor turnover in substance use disorder treatment research: Observations from one multisite trial.,"Background:  Counselor workforce turnover is a critical area of concern for substance use disorder (SUD) treatment providers and researchers. To facilitate the adoption and implementation of innovative treatments, attention must be paid to how SUD treatment workforce issues affect the implementation of clinical effectiveness research. Multiple variables have been shown to relate to turnover, yet reasons that are specific to conducting research have not been systematically assessed.  Methods:  In a randomized clinical trial testing a sexual risk reduction counselor training intervention, 69 counselors at 4 outpatient SUD treatment sites (2 opioid treatment programs [OTPs], 2 psychosocial) were enrolled and randomized to 1 of 2 training conditions (Standard vs. Enhanced). Study counselor and agency turnover rates were calculated. Agency context and policies that impacted research participation were examined.  Results:  Study turnover rates for enrolled counselors were substantial, ranging from 33% to 74% over approximately a 2-year active study period. Study counselor turnover was significantly greater at outpatient psychosocial programs versus OTPs. Counselor turnover did not differ due to demographic or training condition assignment. Leaving agency employment was the most typical reason for study counselor turnover.  Conclusions:  This secondary analysis used data from a multisite study with frontline counselors to provide a qualitative description of challenges faced when conducting effectiveness research in SUD treatment settings. That counselors may be both subjects and deliverers of the interventions studied in clinical trials, with implications for differential impact on study implementation, is highlighted. We offer suggestions for researchers seeking to implement effectiveness research in SUD clinical service settings.",2019,Study counselor turnover was significantly greater at outpatient psychosocial programs versus OTPs.,"['69 counselors at 4 outpatient SUD treatment sites (2 opioid treatment programs [OTPs], 2 psychosocial']",['sexual risk reduction counselor training intervention'],"['Counselor turnover', 'agency turnover rates', 'Study counselor turnover']","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",,0.0389812,Study counselor turnover was significantly greater at outpatient psychosocial programs versus OTPs.,"[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Hatch-Maillette', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Harwick', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Baer', 'Affiliation': 'Department of Psychology, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Masters', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Kasie', 'Initials': 'K', 'LastName': 'Cloud', 'Affiliation': 'CODA Inc. , Portland , Oregon , USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Peavy', 'Affiliation': 'Evergreen Treatment Services , Seattle , Washington , USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': 'CODA Inc. , Portland , Oregon , USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Beadnell', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Wells', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}]",Substance abuse,['10.1080/08897077.2019.1572051']
1099,30445275,Effects of time-varying changes in tobacco and alcohol use on depressive symptoms following pharmaco-behavioral treatment for smoking and heavy drinking.,"BACKGROUND


Complete abstinence from alcohol as well as smoking cessation have been shown to predict reductions in depressive symptoms over time. However, whether reducing alcohol use or smoking positively affect depressive symptoms has yet to be examined. The current study examined depressive symptoms as a function of time-varying changes in alcohol use and smoking status following a pharmaco-behavioral treatment addressing smoking cessation and alcohol reduction.
METHODS


Participants were heavy-drinking smokers (n = 150) followed for 26 weeks after their quit smoking date, with assessments of smoking, alcohol use, and depressive symptoms at baseline and 2, 8, 16, and 26 weeks.
RESULTS


Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01). Exploratory analyses, which excluded observations in which a participant was abstinent, revealed a significant effect of percent change in cigarettes smoked, modeled continuously, on depressive symptoms, (B = 4.39). By contrast, no differences were observed in depressive symptoms in relation to changes in alcohol use.
CONCLUSION


It appears that smoking abstinence is associated with improvements in depression as compared to any level of sustained or reduced use and that the magnitude of smoking reduction may be associated with lower depressive symptoms among those who did not quit successfully. If replicated, these findings may inform treatment for individuals for whom depression is a major barrier to cessation and who have been unable or are unwilling to be completely abstinent from smoking.",2019,"RESULTS


Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01).","['depressive symptoms following pharmaco-behavioral treatment for smoking and heavy drinking', 'Participants were heavy-drinking smokers (n\u2009=\u2009150) followed for 26 weeks after their quit smoking date, with assessments of smoking, alcohol use, and depressive symptoms at baseline and 2, 8, 16, and 26 weeks']",[],['depressive symptoms'],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0199516,"RESULTS


Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01).","[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychological Sciences, Kent State University, 144 Kent Hall, P.O. Box 5190, Kent, OH, 44242-0001, USA; Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA. Electronic address: wlechner@kent.edu.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Sidhu', 'Affiliation': 'Department of Psychological Sciences, Kent State University, 144 Kent Hall, P.O. Box 5190, Kent, OH, 44242-0001, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.09.030']
1100,31897315,Comparison of Nitroglycerin versus Lignocaine Spray to Attenuate Haemodynamic Changes in Elective Surgical Patients Undergoing Direct Laryngoscopy and Endotracheal Intubation: A prospective randomised study.,"Objectives


This study aimed to compare the effects of nitroglycerin (NTG) versus lignocaine spray in blunting the pressor response during direct laryngoscopy and endotracheal intubation.
Methods


This study was conducted between January and June 2018 in the Department of Anesthesiology, Teerthankar Mahaveer Medical College, Moradabad, India. A total of 90 elective surgical patients of American Society of Anesthesiologists physical status grades I or II were divided into three groups, comprising two treatment groups and one control group. Patients in the treatment groups received either one puff (1.5 mg/kg) of lignocaine 10% spray or one puff (400 μg) of NTG spray in the oropharynx one minute prior to the induction of anaesthesia. Haemodynamic variables and mean rate pressure product at baseline and one, two, three, four and five minutes post-induction were compared.
Results


There was a significant reduction in mean heart rate at 3-5 minutes in both treatment groups compared to the control group ( P  <0.050), as well as lower increases in mean arterial pressure at 1-3 minutes ( P  <0.050). However, at 2-4 minutes, there was a significantly greater decrease in mean systolic blood pressure in the NTG group compared to both the lignocaine and control groups ( P  <0.050). Moreover, a greater decrease in mean rate pressure product response at 1-5 minutes was observed in the NTG group compared to the lignocaine and control groups ( P  = 0.001).
Conclusion


The NTG spray was more effective than lignocaine in attenuating blood pressure increases and rate pressure product during elective laryngoscopy and intubation.",2019,"There was a significant reduction in mean heart rate at 3-5 minutes in both treatment groups compared to the control group ( P  <0.050), as well as lower increases in mean arterial pressure at 1-3 minutes ( P  <0.050).","['January and June 2018 in the Department of Anesthesiology, Teerthankar Mahaveer Medical College, Moradabad, India', '90 elective surgical patients of American Society of Anesthesiologists physical status grades', 'Elective Surgical Patients']","['Lignocaine Spray', 'Nitroglycerin', 'Undergoing Direct Laryngoscopy and Endotracheal Intubation', 'lignocaine', 'lignocaine 10% spray or one puff (400 μg) of NTG spray', 'lignocaine spray', 'nitroglycerin (NTG']","['Haemodynamic Changes', 'Haemodynamic variables and mean rate pressure product', 'blood pressure increases and rate pressure product', 'mean arterial pressure', 'mean rate pressure product response', 'mean systolic blood pressure', 'pressor response', 'mean heart rate']","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",90.0,0.0155195,"There was a significant reduction in mean heart rate at 3-5 minutes in both treatment groups compared to the control group ( P  <0.050), as well as lower increases in mean arterial pressure at 1-3 minutes ( P  <0.050).","[{'ForeName': 'Rohit K', 'Initials': 'RK', 'LastName': 'Varshney', 'Affiliation': 'Department of Anesthesiology, Teerthanker Mahaveer Medical College & Research Centre, Teerthanker Mahaveer University, Moradabad, India.'}, {'ForeName': 'Mukesh K', 'Initials': 'MK', 'LastName': 'Prasad', 'Affiliation': 'Department of Anesthesiology, Teerthanker Mahaveer Medical College & Research Centre, Teerthanker Mahaveer University, Moradabad, India.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, Teerthanker Mahaveer University, Moradabad, India.'}]",Sultan Qaboos University medical journal,['10.18295/squmj.2019.19.04.007']
1101,30827716,"Physical Therapy on Postoperative Day Zero Following Total Knee Arthroplasty: A Randomized, Controlled Trial of 394 Patients.","BACKGROUND


Surgeons have increasingly emphasized early mobilization as a way to facilitate discharge following total knee arthroplasty (TKA). The purpose of this study was to determine whether starting formal physical therapy (PT) the afternoon of postoperative day (POD) 0, instead of starting PT the morning of POD 1, could shorten hospital length of stay (LOS).
METHODS


Patients undergoing elective TKA with a planned minimum 1-night hospital stay were randomized to start formal PT the afternoon following surgery or the morning of POD 1. LOS in hours was the primary outcome. An a priori sample size calculation suggested that 394 patients were required to show a 4-hour difference between groups.
RESULTS


Out of 394 patients enrolled and randomized, 378 (95.9%) completed the study. The observed difference in hospital LOS was not large enough to be of clinical significance (intention-to-treat analysis: median of 32.0 hours for POD 0 PT vs 31.0 hours for POD 1 PT, P = .65; as-treated analysis: median of 31.0 hours for POD 0 PT vs 32.0 hours for POD 1 PT, P = .12). Similarly, the observed differences in satisfaction with inpatient PT (10.0 vs 10.0, P = .77), patient-reported readiness for discharge at time of discharge (10.0 vs 10.0, P = .97), and POD 0 pain (3.3 vs 4.0, P = .79) were not large enough to be of clinical significance.
CONCLUSION


While PT on the day of surgery has been suggested as one method to facilitate discharge following TKA, this randomized trial did not demonstrate clinically meaningful differences in hospital LOS or patient satisfaction when PT is initiated on the day of surgery vs on the morning after surgery.",2019,"Similarly, the observed differences in satisfaction with inpatient PT (10.0 vs 10.0, P = .77), patient-reported readiness for discharge at time of discharge (10.0 vs 10.0, P = .97), and POD 0 pain (3.3 vs 4.0, P = .79) were not large enough to be of clinical significance.
","['394 patients', '394 Patients', 'Total Knee Arthroplasty', '394 patients enrolled and randomized, 378 (95.9%) completed the study', 'Patients undergoing elective TKA with a planned minimum 1-night hospital stay']","['starting formal physical therapy (PT', 'Physical Therapy', 'LOS']","['POD 0 pain', 'hospital LOS', 'satisfaction with inpatient PT', 'hospital length of stay (LOS', 'Postoperative Day Zero']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]","[{'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]",394.0,0.215244,"Similarly, the observed differences in satisfaction with inpatient PT (10.0 vs 10.0, P = .77), patient-reported readiness for discharge at time of discharge (10.0 vs 10.0, P = .97), and POD 0 pain (3.3 vs 4.0, P = .79) were not large enough to be of clinical significance.
","[{'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bohl', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Calkins', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Darrith', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tori A', 'Initials': 'TA', 'LastName': 'Edmiston', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tad L', 'Initials': 'TL', 'LastName': 'Gerlinger', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Levine', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.010']
1102,30831358,"Influence of finishing/polishing on the fatigue strength, surface topography, and roughness of an yttrium-stabilized tetragonal zirconia polycrystals subjected to grinding.","This study aimed to evaluate the effects of various polishing systems associated or not to finishing with diamond burs of lower-grit size on the topography, roughness, and fatigue behavior of a ground yttrium-stabilized tetragonal polycrystalline zirconia (Y-TZP). Disc specimens of Y-TZP (Zenostar T, Ivoclar-Vivadent) were produced (diameter = 15 mm, thickness = 1.2 ± 0.2 mm; ISO 6872-2015) and randomly allocated into 8 groups: [Ctrl] as-sintered; [Gr] ground with coarse diamond bur; [Gr+Eve] grinding + polishing with EveDiacera (2-step polishing system); [Gr+Fin+Eve] grinding + finishing + polishing with EveDiacera; [Gr+Kg] grinding + polishing with Kg Viking (2-step polishing system); [Gr+Fin+Kg] grinding + finishing + polishing with Kg Viking; [Gr+Op] grinding + polishing with Optrafine (3-step polishing system); and [Gr+Fin+Op] grinding + finishing + polishing with Optrafine. Next, surface topography, roughness, phase transformation, fatigue strength (staircase method), and fractography analyses were performed. Grinding changed the surface topography and generated higher roughness (Ra in μm) (1.214); the subsequent finishing/polishing procedures were able to reduce the roughness (0.326-0.839); however, it remained higher than the control [ctrl] group (0.221). All samples subjected to surface treatment presented an increase in m-phase content (8.04-17.46%). In terms of fatigue strength (in MPa), the grinding group (677.36) and polishing/finishing groups (641.66-707.20) presented higher fatigue strength than the control [ctrl] group (592.48). Finishing before polishing had no effect on fatigue strength (645.37-707.20). Grinding altered the Y-TZP surface features and increased their fatigue strength by phase transformation mechanism, while the finishing/polishing procedures promoted surface smoothening, while maintaining high fatigue strengths. Finishing as an additional step before polishing had no effect on roughness reduction and fatigue strength improvements; thus, the finishing procedure might be unnecessary.",2019,"Grinding changed the surface topography and generated higher roughness (Ra in μm) (1.214); the subsequent finishing/polishing procedures were able to reduce the roughness (0.326-0.839); however, it remained higher than the control [ctrl] group (0.221).",[],"['coarse diamond bur; [Gr+Eve] grinding\u202f+\u202fpolishing with EveDiacera (2-step polishing system); [Gr+Fin+Eve] grinding\u202f+\u202ffinishing\u202f+\u202fpolishing with EveDiacera; [Gr+Kg] grinding +\u202fpolishing with Kg Viking (2-step polishing system); [Gr+Fin+Kg] grinding\u202f+\u202ffinishing\u202f+\u202fpolishing with Kg Viking; [Gr+Op] grinding\u202f+\u202fpolishing with Optrafine (3-step polishing system); and [Gr+Fin+Op] grinding\u202f+\u202ffinishing\u202f+\u202fpolishing with Optrafine', 'ground yttrium-stabilized tetragonal polycrystalline zirconia (Y-TZP', 'TZP', 'finishing/polishing']","['roughness reduction and fatigue strength improvements', 'fatigue strength, surface topography, and roughness', 'fatigue strength', 'm-phase content', 'Next, surface topography, roughness, phase transformation, fatigue strength (staircase method), and fractography analyses']",[],"[{'cui': 'C0205194', 'cui_str': 'Coarse (qualifier value)'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur (physical object)'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding (procedure)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0007591', 'cui_str': 'M Phase'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",,0.020953,"Grinding changed the surface topography and generated higher roughness (Ra in μm) (1.214); the subsequent finishing/polishing procedures were able to reduce the roughness (0.326-0.839); however, it remained higher than the control [ctrl] group (0.221).","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Marília Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: mariliarippe@mail.ufsm.br.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'School of Dentistry, Meridional Faculty - IMED, Passo Fundo, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Marco Cícero', 'Initials': 'MC', 'LastName': 'Bottino', 'Affiliation': 'School of Dentistry, Dept. of Cariology, Restorative Sciences, Endodontics, University of Michigan, Ann Arbor, MI, USA. Electronic address: mbottino@umich.edu.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: lfvalandro@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.02.013']
1103,30829190,Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial.,"BACKGROUND


Befriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.
METHOD


Patients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.
RESULTS


A total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI -40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.
CONCLUSIONS


Although no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.Declaration of interestNone.",2019,"At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI -40.7 to 58.5, P = 0.72).","['124 patients', 'Patients', 'patients with schizophrenia or related disorders', 'patients with schizophrenia']","['volunteer befriending programme', 'befriending programme for 1 year or to receive information about social activities']","['daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis', 'quality of life, symptoms or self-esteem', 'social contacts', 'mean TUS scores']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",124.0,0.181147,"At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI -40.7 to 58.5, P = 0.72).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Professor, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development),Queen Mary University of London,UK.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Chevalier', 'Affiliation': 'Trial Manager, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development),Queen Mary University of London,UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamborg', 'Affiliation': 'Statistician, Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health,Queen Mary University of London,UK.'}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Golden', 'Affiliation': 'Volunteer Coordinator, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development),Queen Mary University of London,UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Professor, Division of Psychiatry, Faculty of Brain Sciences,University College London,UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Pistrang', 'Affiliation': 'Emeritus Professor, Department of Clinical, Educational and Health Psychology,University College London,UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.42']
1104,29208478,Pilot Testing of a Brief Couple-Based Mind-Body Intervention for Patients With Metastatic Non-Small Cell Lung Cancer and Their Partners.,"CONTEXT


Given the generally incurable nature of metastatic lung cancer, patients and their spouses/partners are at risk for psychological and spiritual distress. To address this concern, we developed a couple-based mind-body (CBMB) intervention.
OBJECTIVES


This formative research aimed at examining the intervention's acceptability and initial efficacy in patients with metastatic lung cancer undergoing treatment and their spouses.
METHODS


Intervention content evaluation sessions and an ensuing single-arm trial were conducted. To evaluate intervention content, participants performed intervention exercises and then participated in semistructured interviews and completed written evaluations. In the single-arm trial, four intervention sessions were delivered over two weeks, focusing on cultivating mindfulness, interpersonal connection, gratitude, and purpose. Newly recruited couples completed measures of depressive symptoms, cancer distress, spiritual well-being, and sleep disturbances before and after the intervention.
RESULTS


Content evaluations by seven dyads of patients and their partners revealed high acceptability ratings for the CBMB intervention (e.g., all participants would recommend the intervention). Consent and adherence rates (54% and 67%, respectively) were acceptable in the single-arm trial. All patients (n = 7 dyads; 67% male; mean age, 55 years) and partners (33% male; mean age, 59 years) rated the intervention as useful. Paired t-test analyses revealed large effect sizes for reduced sleep disturbances (d = 1.83) and medium effect sizes for cancer-specific distress (d = 0.61) for patients and large effect sizes for depressive symptoms (d = 0.90) for partners.
CONCLUSION


Based on these results, the CBMB intervention appears to be acceptable and subjectively useful. In addition, we observed preliminary evidence of quality of life gains in both patients and their partners.",2018,"Paired t-test analyses revealed large effect sizes for reduced sleep disturbances (d = 1.83) and medium effect sizes for cancer-specific distress (d = 0.61) for patients and large effect sizes for depressive symptoms (d = 0.90) for partners.
","['All patients (n\xa0=\xa07 dyads; 67% male; mean age, 55\xa0years) and partners (33% male; mean age, 59\xa0years) rated the intervention as useful', 'Patients', 'patients with metastatic lung cancer undergoing treatment and their spouses']","['CBMB intervention', 'Brief Couple-Based Mind-Body Intervention']","['quality of life gains', 'acceptability ratings', 'depressive symptoms', 'medium effect sizes for cancer-specific distress', 'Consent and adherence rates', 'depressive symptoms, cancer distress, spiritual well-being, and sleep disturbances', 'sleep disturbances']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0034380'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]",67.0,0.0258406,"Paired t-test analyses revealed large effect sizes for reduced sleep disturbances (d = 1.83) and medium effect sizes for cancer-specific distress (d = 0.61) for patients and large effect sizes for depressive symptoms (d = 0.90) for partners.
","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department of Palliative, Rehabilitative & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: kmilbury@mdanderson.org.'}, {'ForeName': 'Rosalinda', 'Initials': 'R', 'LastName': 'Engle', 'Affiliation': 'Department of Palliative, Rehabilitative & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tsao', 'Affiliation': 'Department of Thoracic/Head & Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Owens', 'Affiliation': 'Department of Palliative, Rehabilitative & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Chaoul', 'Affiliation': 'Department of Palliative, Rehabilitative & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative, Rehabilitative & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitative & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2017.11.027']
1105,30816744,Nudging the better angels of our nature: A field experiment on morality and well-being.,"A field experiment examines how moral behavior, moral thoughts, and self-benefiting behavior affect daily well-being. Using experience sampling technology, we randomly grouped participants over 10 days to either behave morally, have moral thoughts, or do something positive for themselves. Participants received treatment-specific instructions in the morning of 5 days and no instructions on the other 5 control days. At each day's end, participants completed measures that examined, among others, subjective well-being, self-perceived morality and empathy, and social isolation and closeness. Full analyses found limited evidence for treatment- versus control-day differences. However, restricting analyses to occasions on which participants complied with instructions revealed treatment- versus control-day main effects on all measures, while showing that self-perceived morality and empathy toward others particularly increased in the moral deeds and moral thoughts group. These findings suggest that moral behavior, moral thoughts, and self-benefiting behavior are all effective means of boosting well-being, but only moral deeds and, perhaps surprisingly, also moral thoughts strengthen the moral self-concept and empathy. Results from an additional study assessing laypeople's predictions suggest that people do not fully intuit this pattern of results. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Full analyses found limited evidence for treatment- versus control-day differences.,[],[],"['subjective well-being, self-perceived morality and empathy, and social isolation and closeness']",[],[],"[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]",,0.0222172,Full analyses found limited evidence for treatment- versus control-day differences.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Waytz', 'Affiliation': 'Kellogg School of Management.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000588']
1106,30776909,Effect of Iron Isomaltoside on Skeletal Muscle Energetics in Patients With Chronic Heart Failure and Iron Deficiency.,"BACKGROUND


Iron repletion augments exercise capacity in chronic heart failure (HF), but there is a lack of mechanistic data explaining how iron could augment exercise performance despite minimal changes in hemoglobin (Hb). Besides Hb, iron is an obligate component of mitochondrial enzymes that generate cellular energy in the form of adenosine triphosphate and phosphocreatine (PCr). Dynamic phosphorus magnetic resonance spectroscopy is a noninvasive tool that quantifies in vivo muscle energetics by measuring the kinetics of PCr recovery after exertion. We tested the hypothesis that intravenous iron repletion in chronic HF enhances skeletal muscle energetics as reflected by shorter PCr recovery half-times (PCr t 1/2 ) on phosphorus magnetic resonance spectroscopy.
METHODS


We enrolled 40 patients (50% anemic) with chronic HF, New York Heart Association class ≥II, left ventricular ejection fraction ≤45%, and iron deficiency (ferritin<100 μg/L or 100-300 μg/L with transferrin saturation <20%). Subjects underwent stratified (anemic versus nonanemic) randomization (1:1) to a single, double-blinded, total dose infusion of iron isomaltoside or saline placebo with end points reassessed early at 2 weeks posttreatment to minimize confounding from exercise adaptation. The primary end point was PCr t 1/2  at 2 weeks. Secondary end points included ADP recovery half-time (ADP t 1/2;  energetic marker), iron status, symptoms, Hb, exercise capacity, and safety.
RESULTS


In the total population, treatment groups were similar at baseline. At 2 weeks, iron isomaltoside improved PCr t 1/2  (adjusted difference, -6.8 s; 95% CI, 11.5 to -2.1; P=0.006), ADP t 1/2  (-5.3 s; 95% CI, -9.7 to -0.9; P=0.02), ferritin (304 ng/mL; 95% CI, 217-391; P<0.0001), transferrin saturation (6.8%; 95% CI, 2.7-10.8; P=0.002), New York Heart Association class (-0.23; 95% CI, -0.46 to -0.01; P=0.04), resting respiratory rate (-0.7 breaths/min; 95% CI, -1.2 to -0.2; P=0.009), and postexercise Borg dyspnea score (-2.0; 95% CI, -3.7 to -0.3; P=0.04), but not Hb (2.4 g/L; 95% CI, -3.5 to 8.4; P=0.41). Adverse events were similar between groups. In subgroup analyses, iron isomaltoside improved PCr t 1/2  in anemic (-8.4 s; 95% CI, -16.7 to -0.2; P=0.04) and nonanemic (-5.2 s; 95% CI, -10.6 to 0.2; P=0.06) cohorts.
CONCLUSIONS


In patients with chronic HF and iron deficiency, a total repletion dose of iron isomaltoside given at a single sitting is well tolerated and associated with faster skeletal muscle PCr t 1/2  at 2 weeks, implying better mitochondrial function. Augmented skeletal muscle energetics might therefore be an important mechanism via which iron repletion confers benefits in chronic HF despite minimal Hb changes.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005592-13/GB . Unique identifier: EudraCT 2012-005592-13.",2019,"resting respiratory rate (-0.7 breaths/min; 95% CI, -1.2 to -0.2; P=0.009), and postexercise Borg dyspnea score (-2.0; 95% CI, -3.7 to -0.3; P=0.04), but not Hb (2.4 g/L; 95% CI, -3.5 to 8.4; P=0.41).","['chronic heart failure (HF', 'Patients With Chronic Heart Failure and Iron Deficiency', 'patients with chronic HF and iron deficiency', 'enrolled 40 patients (50% anemic) with chronic HF, New York Heart Association class ≥II, left ventricular ejection fraction ≤45%, and iron deficiency (ferritin<100 μg/L or 100-300 μg/L with']","['Dynamic phosphorus magnetic resonance spectroscopy', 'iron isomaltoside or saline placebo', 'transferrin saturation', 'Iron Isomaltoside']","['resting respiratory rate', 'Adverse events', 'ferritin', 'iron isomaltoside improved PCr t 1/2  in anemic', 'Skeletal Muscle Energetics', 'New York Heart Association class', 'ADP recovery half-time (ADP t 1/2;  energetic marker), iron status, symptoms, Hb, exercise capacity, and safety', 'postexercise Borg dyspnea score', 'nonanemic', 'transferrin saturation']","[{'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}]",40.0,0.630092,"resting respiratory rate (-0.7 breaths/min; 95% CI, -1.2 to -0.2; P=0.009), and postexercise Borg dyspnea score (-2.0; 95% CI, -3.7 to -0.3; P=0.04), but not Hb (2.4 g/L; 95% CI, -3.5 to 8.4; P=0.41).","[{'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Charles-Edwards', 'Affiliation': ""School of Imaging Sciences and Biomedical Engineering, King's College, London, UK (G.C.-E.).""}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Amaral', 'Affiliation': ""King's College London British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, James Black Centre, UK (N.A., N.C., T.M., M.M., A.M.S., D.O.O.).""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Sleigh', 'Affiliation': 'Wolfson Brain Imaging Centre, University of Cambridge School of Clinical Medicine, UK (A.S.).'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Ayis', 'Affiliation': 'School of Population Health and Environmental Sciences, Kings College London, UK (S.A.).'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Catibog', 'Affiliation': ""King's College London British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, James Black Centre, UK (N.A., N.C., T.M., M.M., A.M.S., D.O.O.).""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McDonagh', 'Affiliation': ""King's College London British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, James Black Centre, UK (N.A., N.C., T.M., M.M., A.M.S., D.O.O.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Monaghan', 'Affiliation': ""King's College London British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, James Black Centre, UK (N.A., N.C., T.M., M.M., A.M.S., D.O.O.).""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Amin-Youssef', 'Affiliation': ""Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK (N.A., N.C., T.M., M.M., G.A.-Y., A.M.S., D.O.O.).""}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Kemp', 'Affiliation': 'Department of Musculoskeletal Biology, University of Liverpool and MRC-Arthritis Research UK Centre for Integrated research into Musculoskeletal Ageing (CIMA), Liverpool (G.J.K.).'}, {'ForeName': 'Ajay M', 'Initials': 'AM', 'LastName': 'Shah', 'Affiliation': ""King's College London British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, James Black Centre, UK (N.A., N.C., T.M., M.M., A.M.S., D.O.O.).""}, {'ForeName': 'Darlington O', 'Initials': 'DO', 'LastName': 'Okonko', 'Affiliation': ""King's College London British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, James Black Centre, UK (N.A., N.C., T.M., M.M., A.M.S., D.O.O.).""}]",Circulation,['10.1161/CIRCULATIONAHA.118.038516']
1107,30782070,Effectiveness of telemonitoring-enhanced support over structured telephone support in reducing heart failure-related healthcare utilization in a multi-ethnic Asian setting.,"AIMS


Our study aimed to compare the effectiveness of telemonitoring over structured telephone support in reducing heart failure-related healthcare utilization.
METHODS


This was a non-randomised controlled study comparing 150 recently discharged heart failure patients enrolled into telemonitoring and 55 patients who only received structured telephone support after rejecting telemonitoring. Patient activation, knowledge and self-management levels were measured at baseline and the one year upon programme completion using the Patient Activation Measure, the Dutch Heart Failure Knowledge Scale and the Self-Care of Heart Failure Index respectively. Differences in heart failure-related and all-cause hospitalization rates, total bed days and mortality rates at 180 days and at one year, knowledge and self-management scores and total cost of care between groups at one year were analysed.
RESULTS


Average age of telemonitoring was 57.9 years and 63.9 years for structured telephone support. Significant difference in adjusted 180-day all-cause bed days (telemonitoring: five days versus structured telephone support: 9.8 days), heart failure-related bed days (telemonitoring: 1.2 days versus structured telephone support: six days) and adjusted one-year heart failure-related bed days (telemonitoring: 2.2 days versus structured telephone support: 6.6 days) were observed. Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32,  p  = 0.02). Estimated mean maintenance and confidence scores were significantly higher in the telemonitoring group at one year. No differences in all-cause and HF-related readmission rates and knowledge levels were observed. The one-year total cost of care was predicted to be Singapore dollars (SG$) 2774.4 lower ( p  = 0.07) in telemonitoring.
CONCLUSION


In conclusion, telemonitoring was associated with lower all-cause and heart failure-related total bed days at 180 days, lower heart failure-related total bed days and total cost of care at one year as compared with structured telephone support.",2020,"Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p = 0.02).","['Average age of telemonitoring was 57.9 years and 63.9 years for structured telephone support', 'a multi-ethnic Asian setting', '150 recently discharged heart failure patients enrolled into telemonitoring and 55 patients who only received']","['telemonitoring over structured telephone support', 'structured telephone support after rejecting telemonitoring', 'telemonitoring-enhanced support over structured telephone support']","['Patient activation, knowledge and self-management levels', 'knowledge and self-management scores and total cost of care', 'heart failure', 'Dutch Heart Failure Knowledge Scale and the Self-Care of Heart Failure Index respectively', 'heart failure-related and all-cause hospitalization rates, total bed days and mortality rates', 'heart failure-related healthcare utilization', 'Estimated mean maintenance and confidence scores', 'Singapore dollars (SG', 'heart failure-related total bed days and total cost of care', 'cause and HF-related readmission rates and knowledge levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0222045'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",150.0,0.0585862,"Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p = 0.02).","[{'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Leng Chow', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Chaw Yu K', 'Initials': 'CYK', 'LastName': 'Aung', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Shao Chuen', 'Initials': 'SC', 'LastName': 'Tong', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Geraldine Sl', 'Initials': 'GS', 'LastName': 'Goh', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'MacDonald', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Angela Nk', 'Initials': 'AN', 'LastName': 'Ng', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Atikah E', 'Initials': 'AE', 'LastName': 'Ahmad', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Mei Foon', 'Initials': 'MF', 'LastName': 'Yap', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Leong', 'Affiliation': 'Thomson Medical Centre Hospital, Singapore.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Bruege', 'Affiliation': 'Philips Population Health Management, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Tesanovic', 'Affiliation': 'Philips Research, Eindhoven, The Netherlands.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riistama', 'Affiliation': 'Philips Research, Eindhoven, The Netherlands.'}, {'ForeName': 'Sze Yunn', 'Initials': 'SY', 'LastName': 'Pang', 'Affiliation': 'Health Informatics and Population Management, Philips ASEAN Pacific, Singapore.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Erazo', 'Affiliation': 'Health Informatics and Population Management, Philips ASEAN Pacific, Singapore.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18825164']
1108,31216086,"Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection.","Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single-arm, open-label, phase 3, deferred treatment study, we investigated the efficacy and safety of sofosbuvir-velpatasvir among patients randomized to the placebo group in the ASTRAL-1 study. Patients received sofosbuvir-velpatasvir (400/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12). The primary safety endpoint was any adverse events (AEs) leading to the permanent discontinuation of study drug. Overall, 108/111 (97%, 95% confidence interval [CI], 92%-99%) achieved SVR12, and only one patient had virological failure. SVR12 was achieved by 61/63 (97%, 95%CI, 89%-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83%-100%) with genotype 2, 19/19 (100%; 95%CI, 82%-100%) with genotype 4 and 8/9 (89%; 95% CI, 52%-100%) with genotype 6. All (19/19; 95%CI, 82-100) patients with cirrhosis and all (31/31, 95%CI, 89-100) with prior treatment experience achieved SVR12. The safety profile during treatment was similar to that observed in patients receiving placebo treatment. The most common AEs were headache, fatigue and nausea. One patient (1%) discontinued treatment due to an AE of gallbladder carcinoma, which was not considered related to treatment. Of five reported serious AEs, none were considered related to study drug. Sofosbuvir-velpatasvir for 12 weeks was effective and well tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4 or 6 infection, including those with compensated cirrhosis (ClinicalTrials.gov NCT02346721).",2019,"SVR12 was achieved by 61/63 (97%, 95%CI, 89-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83-100%) with genotype 2, 19/19 (100%; 95%CI, 82-100%) with genotype 4, and 8/9 (89%; 95% CI, 52-100%) with genotype 6.",[],"['placebo', 'sofosbuvir-velpatasvir']","['proportion of patients with sustained virologic response', 'headache, fatigue, and nausea', 'SVR12', 'SVR12.The safety profile', 'effective and well-tolerated', 'efficacy and safety', 'adverse events (AEs) leading to the permanent discontinuation of study drug', 'virological failure']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C4079582', 'cui_str': 'velpatasvir'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",100.0,0.418454,"SVR12 was achieved by 61/63 (97%, 95%CI, 89-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83-100%) with genotype 2, 19/19 (100%; 95%CI, 82-100%) with genotype 4, and 8/9 (89%; 95% CI, 52-100%) with genotype 6.","[{'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Asselah', 'Affiliation': 'Hepatology Department, Head of Viral Hepatitis Team, INSERM UMR1149, Beaujon Hospital, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Shafran', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bourgeois', 'Affiliation': 'Ziekenhuis Netwerk Antwerpen STER Site Stuivenberg, Antwerpen, Belgium.'}, {'ForeName': 'Ching-Lung', 'Initials': 'CL', 'LastName': 'Lai', 'Affiliation': 'The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mathurin', 'Affiliation': 'Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Willems', 'Affiliation': 'Université de Montréal, Québec, Canada.'}, {'ForeName': 'Mindie H', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Stanford University Medical Center, Stanford, California, USA.'}, {'ForeName': 'Mitchell N', 'Initials': 'MN', 'LastName': 'Davis', 'Affiliation': 'South Florida Center of Gastroenterology, Wellington, Florida, USA.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Evguenia', 'Initials': 'E', 'LastName': 'Svarovskaia', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNally', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Obaid S', 'Initials': 'OS', 'LastName': 'Shaikh', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Tram T', 'Initials': 'TT', 'LastName': 'Tran', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}]",Journal of viral hepatitis,['10.1111/jvh.13159']
1109,30792142,Effect of procyanidin on dietary iron absorption in hereditary hemochromatosis and in dysmetabolic iron overload syndrome: A crossover double-blind randomized controlled trial.,"BACKGROUND & AIMS


Type I hereditary hemochromatosis (HH) and dysmetabolic iron overload syndrome (DIOS) are the two most prevalent iron overload diseases. Although many food components, particularly polyphenols, reduce iron bioavailability, there is no clinically validated nutritional strategy to reduce food-iron absorption in patients with these diseases. We aimed to determine whether supplementation with 100 mg of procyanidins during a meal reduces dietary iron absorption in patients with HH or DIOS.
METHODS


20 HH and 20 DIOS patients were enrolled in a double-blind three-period crossover randomized study. Basal serum iron level was measured following an overnight fast. Each patient consumed a standardized test iron-rich meal containing 43 mg of iron with two capsules of placebo or procyanidin supplementation. Each period was separated by a 3-day wash-out period. The primary objective was a reduction of dietary iron absorption, assessed by a reduction of serum-iron area under the curve (AUC) corrected for baseline serum iron.
RESULTS


All patients completed the study. The meal and the procyanidin supplements were well tolerated. In both HH and DIOS patients, the iron-rich meal induced a significant increase of serum iron compared with baseline at 120, 180, 240 min, from 8 to 9.1% (p = 0.002, 0.001 and 0.003, respectively) in DIOS and from 15.8 to 25.7% (p < 0.001) in HH. Iron absorption was 3.5-fold higher in HH than in DIOS (p < 0.001). Procyanidin supplementation did not significantly modify iron absorption in DIOS (AUC of added iron 332.87 ± 649.55 vs 312.61 ± 678.61 μmol.h/L, p = 0.916) or in HH (1168.62 ± 652.87 vs 1148.54 μmol.h/L ± 1290.05, p = 0.917).
CONCLUSIONS


An iron-rich test meal led to a marked increase in iron absorption in HH but a mild increase in DIOS. Procyanidin supplementation does not significantly reduce dietary iron absorption in either disease. CLINICAL TRIAL REGISTRY: clinicaltrials.gov (NCT03453918).",2020,Iron absorption was 3.5-fold higher in HH than in DIOS (p < 0.001).,"['patients with these diseases', 'patients with HH or DIOS', '678.61', '20 HH and 20 DIOS patients', 'hereditary hemochromatosis and in dysmetabolic iron overload syndrome']","['supplementation with 100\xa0mg of procyanidins', 'standardized test iron-rich meal containing 43\xa0mg of iron with two capsules of placebo or procyanidin supplementation', 'procyanidin', 'Procyanidin supplementation']","['tolerated', 'reduction of dietary iron absorption, assessed by a reduction of serum-iron area under the curve (AUC) corrected for baseline serum iron', 'Iron absorption', 'iron absorption in HH', 'dietary iron absorption', 'serum iron', 'iron absorption in DIOS', 'Basal serum iron level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0854076', 'cui_str': 'DIOS'}, {'cui': 'C0392514', 'cui_str': 'Familial Hemochromatosis'}, {'cui': 'C0282193', 'cui_str': 'Iron Overload'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0072061', 'cui_str': '2H-1-Benzopyran-3,4,5,7-tetrol, 2-(3,4-dihydroxyphenyl)-2-((2-(3,4-dihydroxyphenyl)-3,4-dihydro-5,7-dihydroxy-2H-1-benzopyran-3-yl)oxy)-3,4-dihydro-'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0376520', 'cui_str': 'Dietary Iron'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0854076', 'cui_str': 'DIOS'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",,0.44101,Iron absorption was 3.5-fold higher in HH than in DIOS (p < 0.001).,"[{'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lobbes', 'Affiliation': 'Internal Medicine Department, University Hospital Clermont-Ferrand, F-63003, France. Electronic address: hervelobbes@gmail.com.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Gladine', 'Affiliation': 'Université Clermont Auvergne, INRA, UNH, Unité de Nutrition Humaine, CRNH Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Université Clermont Auvergne, INRA, UNH, Unité de Nutrition Humaine, CRNH Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'University Hospital Clermont-Ferrand, Biostatistics Unit, Clermont-Ferrand, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': 'Clinical Pharmacology Department CPC/CIC INSERM 1405, Clermont-Auvergne University, University Hospital Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Cardot', 'Affiliation': 'Clermont-Auvergne University, MEDIS and CIC1405, INSERM, CS 60032, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruivard', 'Affiliation': 'Internal Medicine Department, University Hospital Clermont-Ferrand, F-63003, France; Clermont-Auvergne University, CRNS, SIGMA Clermont, Institute Pascal, F-63000 Clermont-Ferrand, France.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.012']
1110,30792143,High molecular weight oat β-glucan enhances lipid-lowering effects of phytosterols. A randomised controlled trial.,"BACKGROUND & AIMS


Oat β-glucan (OBG) and phytosterols (PS) are known to lower blood cholesterol levels via different mechanisms. Combination of high molecular weight (MW) OBG and PS in a single functional food could have complementary and/or synergistic effects for optimising heart health. The aim of this study was to investigate the effects of dietary supplementation with high-MW OBG with or without PS on plasma lipids in hypercholesterolaemic individuals.
METHODS


In a double-blinded, placebo-controlled, 2 × 2 factorial trial, participants were randomised to receive biscuits fortified with either no PS or OBG (PL, n = 18) or 2 g PS (PS, n = 18), 3 g OBG (OBG, n = 18), or combination of 2 g PS and 3 g OBG (PS-OBG, n = 18) per day for 6 weeks. Primary outcome was fasting plasma total cholesterol (TC) and secondary outcomes were LDL-cholesterol, LDL-C; HDL-cholesterol, HDL-C; triglycerides, TG and TC to HDL-cholesterol (TC:HDL) ratio.
RESULTS


TC and LDL-C were significantly lowered following PS (-4.6% and -7.6% respectively; p < 0.05), OBG (-5.7% and -8.6%; p < 0.01) and PS-OBG (-11.5% and -13.9%; p < 0.0001) administration. The reduction in TC in the PS-OBG group was significantly greater compared to PL (p < 0.001) and PS (p < 0.05). PS-OBG group had a significantly greater reduction in LDL-C compared to PL (p < 0.01) but not in comparison to PS or OBG groups. TC:HDL ratio was significantly reduced following PS-OBG (-8.9%; p < 0.01) only, and there was no significant difference found between groups. Plasma TG reduced by 8.4% following PS-OBG, however, this was statistically non-significant. Plasma HDL-C remained unchanged across all groups.
CONCLUSIONS


Dietary supplementation with high-MW OBG and PS in a single functional food enhances their lipid-lowering potential. Blood cholesterol lowering by PS and OBG is additive. Delivery of these two bioactive nutrients in a single food allows optimisation of their lipid-lowering effects and may provide added heart health benefits with enhanced compliance. The trial was registered with the Australian New Zealand Clinical Trials Registry at http://www.anzctr.org.au/(ACTRN12618001455257).",2020,PS-OBG group had a significantly greater reduction in LDL-C compared to PL (p < 0.01) but not in comparison to PS or OBG groups.,['hypercholesterolaemic individuals'],"['Oat β-glucan (OBG) and phytosterols (PS', 'placebo', 'biscuits fortified with either no PS or OBG (PL, n\xa0=\xa018) or 2\xa0g PS', 'TC', 'PS-OBG', 'dietary supplementation with high-MW OBG with or without PS', 'high molecular weight (MW) OBG and PS']","['Plasma HDL-C', 'OBG', 'reduction in TC', 'HDL ratio', 'Blood cholesterol lowering', 'PS-OBG', 'Plasma TG', 'fasting plasma total cholesterol (TC) and secondary outcomes were LDL-cholesterol, LDL-C; HDL-cholesterol, HDL-C; triglycerides, TG and TC to HDL-cholesterol (TC:HDL) ratio', 'LDL-C', 'TC and LDL-C']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.3613,PS-OBG group had a significantly greater reduction in LDL-C compared to PL (p < 0.01) but not in comparison to PS or OBG groups.,"[{'ForeName': 'Jessica Ja', 'Initials': 'JJ', 'LastName': 'Ferguson', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, 305C Medical Science Building, University of Newcastle, Callaghan, NSW, 2308, Australia. Electronic address: Jessica.Ferguson@uon.edu.au.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Stojanovski', 'Affiliation': 'School of Mathematics and Physical Sciences, University of Newcastle, Callaghan, NSW, 2308, Australia. Electronic address: Elizabeth.Stojanovski@newcastle.edu.au.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'MacDonald-Wicks', 'Affiliation': 'School of Health Sciences, Faculty of Health & Medicine, University of Newcastle, Callaghan, NSW, 2308, Australia. Electronic address: Lesley-Wicks@newcastle.edu.au.'}, {'ForeName': 'Manohar L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, 305C Medical Science Building, University of Newcastle, Callaghan, NSW, 2308, Australia. Electronic address: Manohar.Garg@newcastle.edu.au.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.007']
1111,31702015,Skeletal Effects of Levothyroxine for Subclinical Hypothyroidism in Older Adults: A TRUST Randomized Trial Nested Study.,"CONTEXT


Both thyroid dysfunction and levothyroxine (LT4) therapy have been associated with bone loss, but studies on the effect of LT4 for subclinical hypothyroidism (SHypo) on bone yielded conflicting results.
OBJECTIVE


To assess the effect of LT4 treatment on bone mineral density (BMD), Trabecular Bone Score (TBS), and bone turnover markers (BTMs) in older adults with SHypo.
DESIGN AND INTERVENTION


Planned nested substudy of the double-blind placebo-controlled TRUST trial. Participants with SHypo were randomized to LT4 with dose titration versus placebo with computerized mock titration.
SETTING AND PARTICIPANTS


196 community-dwelling adults over 65 years enrolled at the Swiss TRUST sites had baseline and 1-year follow-up bone examinations; 4 participants withdrew due to adverse events not related to treatment.
MAIN OUTCOME MEASURES


One-year percentage changes of BMD, TBS, and 2 serum BTMs (serum CTX-1 [sCTX] and procollagen type 1 N-terminal polypeptide [P1NP]). Student's t-test for unadjusted analyses and linear regression adjusted for clinical center and sex were performed.
RESULTS


Mean age was 74.3 years ± 5.7, 45.4% were women, and 19.6% were osteoporotic. The unadjusted 1-year change in lumbar spine BMD was similar between LT4 (+0.8%) and placebo-treated groups (-0.6%; between-groups difference +1.4%: 95% confidence interval [CI] -0.1 to 2.9, P = .059). Likewise, there were no between-group differences in 1-year change in TBS (-1.3%: 95% CI -3.1 to 0.6, P = .19), total hip BMD (-0.2%: 95% CI -1.1 to 0.1, P = .61), or BTMs levels (sCTX +24.1%: 95% CI -7.9 to 56.2, P = .14), or after adjustment for clinical centers and sex.
CONCLUSIONS


Over 1-year levothyroxine had no effect on bone health in older adults with SHypo.
REGISTRATION


ClinicalTrial.gov NCT01660126 and NCT02491008.",2020,"The unadjusted 1-year change in lumbar spine BMD was similar between LT4 (+0.8%) and placebo-treated groups (-0.6%; between-groups difference +1.4%: 95%CI -0.1 to 2.9, p=0.059).","['Participants with SHypo', '196 community-dwelling adults over 65 years enrolled at the Swiss TRUST sites had baseline and 1-year follow-up bone examinations; 4 participants withdrew due to adverse events not related to treatment', 'Older Adults', 'older adults with SHypo', 'Mean age was 74.3y ± 5.7, 45.4% were women, and 19.6% were osteoporotic']","['Levothyroxine', 'levothyroxine therapy', 'LT4', 'placebo', 'LT4 with dose titration vs. placebo', 'levothyroxine']","['total hip BMD', 'bone health', 'lumbar spine BMD', 'BMD, TBS, and two serum BTMs (sCTX and P1NP', '1-year change in TBS', 'bone mineral density (BMD), Trabecular Bone Score (TBS), and bone turnover markers (BTMs', 'BTMs levels']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",196.0,0.653512,"The unadjusted 1-year change in lumbar spine BMD was similar between LT4 (+0.8%) and placebo-treated groups (-0.6%; between-groups difference +1.4%: 95%CI -0.1 to 2.9, p=0.059).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gonzalez Rodriguez', 'Affiliation': 'Center of Bone Diseases, Rheumatology Unit, Bone and Joint Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Mirah', 'Initials': 'M', 'LastName': 'Stuber', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Del Giovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Axel L', 'Initials': 'AL', 'LastName': 'Löwe', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicolien A', 'Initials': 'NA', 'LastName': 'van Vliet', 'Affiliation': 'Department of Internal Medicine, Section Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'van Heemst', 'Affiliation': 'Department of Internal Medicine, Section Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Departments of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mooijaart', 'Affiliation': 'Departments of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rudi G J', 'Initials': 'RGJ', 'LastName': 'Westendorp', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aeberli', 'Affiliation': 'Department of Rheumatology and Clinical Immunology/Allergology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'Departments of Medicine, Epidemiology and Biostatistics, University of California, San Francisco, US.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Hans', 'Affiliation': 'Center of Bone Diseases, Rheumatology Unit, Bone and Joint Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz058']
1112,31736187,Stress-related suppression of peripheral cytokines predicts future relapse in alcohol-dependent individuals with and without subclinical depression.,"Chronic alcohol abuse and depressive symptoms are both associated with peripheral cytokine changes. Despite this, cytokine adaptations have not been assessed in co-morbid populations or prospectively as predictors of relapse. We examine cytokine responses to stress in alcohol-dependent individuals and social drinkers, both with and without subclinical depression. We also examine the potential link between cytokine adaptations in response to stress and prospective alcohol relapse risk. Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms) were exposed to two 5-minute personalized guided imagery conditions (stress and neutral) across consecutive days in a randomized and counterbalanced order. Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure. Following treatment discharge, follow-up interviews were conducted over 90 days to assess relapse. Dampened IL-1ra and IL-6 in response to stress was observed as a function of alcohol dependence and not moderated by depressive symptoms. Lower levels of IL-6 following stress also predicted greater drinking days following treatment. Conversely, high depressive symptomatology was associated solely with pro-inflammatory adaptations. Stress-related suppression of TNFα predicted drinking severity only in alcohol-dependent individuals with subclinical depression, and suppressed TNFR1 following stress was only seen in individuals with subclinical depression. Stress-induced suppression of pro-inflammatory TNF markers may indicate a risk factor for alcohol-dependent individuals with co-occurring depressive symptoms.",2019,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","['alcohol-dependent individuals with and without subclinical depression', 'Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms', 'alcohol-dependent individuals and social drinkers, both with and without subclinical depression']",['5-minute personalized guided imagery conditions (stress and neutral'],"['Chronic alcohol abuse and depressive symptoms', 'Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0077503', 'cui_str': 'TNF Receptors'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}]",,0.0329056,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Department of Psychiatry, School of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'MacDougall', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'LaVallee', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Simpson', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, The Connecticut Mental Health Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Addiction biology,['10.1111/adb.12832']
1113,30803323,The feasibility of online video calling to engage patients with cystic fibrosis in exercise training.,"INTRODUCTION


Physical activity, including structured exercise, is an essential component in the management of cystic fibrosis. The use of telehealth such as video-calling may be a useful method for the delivery of exercise and physical activity interventions, though the feasibility of this remains unknown.
METHODS


Nine patients with cystic fibrosis (three female, six male, 30.9 ± 8.7 years) volunteered to participate. Participants completed an eight-week exercise training intervention conducted via Skype, using personalised exercises, with all sessions supervised by an exercise therapist. Feasibility was assessed by demand, implementation, practicality and acceptability. Changes in anthropometric, pulmonary, physical activity and quality of life variables were also assessed.
RESULTS


Two male participants withdrew from the study, citing lack of available time. The remaining participants found use of Skype useful, with a mean satisfaction rating of 9/10, and three participants requesting to continue the sessions beyond the duration of the study. Mean compliance with sessions was 68%, with mean duration of sessions being 20 min. A total of 25% of calls suffered from technical issues such as video or audio lags. Anthropometric, pulmonary, physical activity and quality of life variables remained unchanged over the course of the study period.
DISCUSSION


The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants. Findings have implications for clinical practice and could allow care teams to engage patients remotely in exercise. Further research is required to assess the efficacy of this modality on increasing physical activity and associated health outcomes.",2020,"The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants.","['Nine patients with cystic fibrosis (three female, six male, 30.9\u2009±\u20098.7 years) volunteered to participate', 'engage patients with cystic fibrosis in exercise training', 'Two male participants withdrew from the study, citing lack of available time']","['exercise training intervention conducted via Skype, using personalised exercises, with all sessions supervised by an exercise therapist', 'exercise intervention', 'online video calling']","['Anthropometric, pulmonary, physical activity and quality of life variables', 'Mean compliance', 'Changes in anthropometric, pulmonary, physical activity and quality of life variables', 'demand, implementation, practicality and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",2.0,0.0180621,"The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants.","[{'ForeName': 'Owen W', 'Initials': 'OW', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shelley', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Trott', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Bowhay', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': 'Research and Development Directorate, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Sheldon', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19828630']
1114,30779061,Comparison between antimicrobial-coated sutures and uncoated sutures for the prevention of surgical site infections in plastic surgery: a double blind control trial.,"OBJECTIVE


Surgical site infection (SSI) produces considerable morbidity and increases health care costs. One of its causes is microbial adherence to the surgical sutures surface. A strategy to avoid microbial colonization is the use of antimicrobial-impregnated sutures. Recently absorbable sutures treated with chlorhexidine (CHX) have been developed. Our study purpose was to compare CHX-coated and uncoated suture in elective plastic surgery.
PATIENTS AND METHODS


We conducted a randomized, double-blind, single-centre controlled trial of 18 patients undergoing elective bilateral mammary surgery and 18 patients undergoing skin lesions removals. Patients were divided into 2 groups receiving antibacterial-coated (study group) and uncoated (controlled group) sutures for wound closure. Patients were evaluated for scar results and signs of SSIs were monitored over a period of 30 days (or 1 year in case of prosthetic surgery). Statistical comparison was performed using dependent t-tests for paired samples.
RESULTS


For patients undergoing mammary surgery, based on Vancouver Scale, there were no significant differences between the two groups. We noticed that in 8 patients the vertical scars belonging to the control group were larger than the contralateral 8 vertical sutures belonging to the study group. For patients undergoing skin surgery, surgical wounds treated with uncoated sutures were significantly more erythematous than the ones belonging to the study group (Media: 0,8333% vs. 1,5556%, respectively; standard deviation: 9,235 vs. 0,6157; 95%; p=0.0092).
CONCLUSIONS


No wounds infection was reported between the two groups. Based on our experience, we conclude that the use of CHX-coated sutures should be considered in case of inflamed lesions removal. Further studies are needed to validate our results.",2019,No wounds infection was reported between the two groups.,"['and 18 patients undergoing skin lesions removals', '18 patients undergoing', 'plastic surgery']","['CHX-coated sutures', 'chlorhexidine (CHX', 'elective bilateral mammary surgery', 'CHX-coated and uncoated suture', 'antimicrobial-coated sutures and uncoated sutures', 'antibacterial-coated (study group) and uncoated (controlled group) sutures for wound closure']","['wounds infection', 'scar results and signs of SSIs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0191322', 'cui_str': 'Excision of lesion of skin (procedure)'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}]","[{'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",18.0,0.118994,No wounds infection was reported between the two groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carella', 'Affiliation': 'Department of General Surgery, Plastic Surgery ""P. Valdoni"", Policlinico Umberto I, Sapienza University of Rome, Rome, Italy. carellasara@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fioramonti', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Onesti', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Scuderi', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201902_16982']
1115,30423449,"Efficacy, Safety, and Quality of Life in a Multicenter, Randomized, Placebo-Controlled Trial of Low-Dose Peanut Oral Immunotherapy in Children with Peanut Allergy.","BACKGROUND


Only 2 small placebo-controlled trials on peanut oral immunotherapy (OIT) have been published.
OBJECTIVE


We examined the efficacy, safety, immunologic parameters, quality of life (QOL), and burden of treatment (BOT) of low-dose peanut OIT in a multicenter, double-blind, randomized placebo-controlled trial.
METHODS


A total of 62 children aged 3 to 17 years with IgE-mediated, challenge-proven peanut allergy were randomized (1:1) to receive peanut OIT with a maintenance dose of 125 to 250 mg peanut protein or placebo. The primary outcome was the proportion of children tolerating 300 mg or more peanut protein at oral food challenge (OFC) after 16 months of OIT. We measured the occurrence of adverse events (AEs), immunologic changes, and QOL before and after OIT and BOT during OIT.
RESULTS


Twenty-three of 31 (74.2%) children of the active group tolerated at least 300 mg peanut protein at final OFC compared with 5 of 31 (16.1%) in the placebo group (P < .001). Thirteen of 31 (41.9%) children of the active versus 1 of 31 (3.2%) of the placebo group tolerated the highest dose of 4.5 g peanut protein at final OFC (P < .001). There was no significant difference between the groups in the occurrence of AE-related dropouts or in the number, severity, and treatment of objective AEs. In the peanut-OIT group, we noted a significant reduction in peanut-specific IL-4, IL-5, IL-10, and IL-2 production by PBMCs compared with the placebo group, as well as a significant increase in peanut-specific IgG 4  levels and a significant improvement in QOL; 86% of children evaluated the BOT positively.
DISCUSSION


Low-dose OIT is a promising, effective, and safe treatment option for peanut-allergic children, leading to improvement in QOL, a low BOT, and immunologic changes showing tolerance development.",2019,"There was no significant difference between the groups in the occurrence of AE-related dropouts or in the number, severity, and treatment of objective AEs.","['62 children aged 3 to 17 years with IgE-mediated, challenge-proven peanut allergy', 'Twenty-three of 31 (74.2', 'peanut-allergic children', 'Children with Peanut Allergy']","['placebo', 'Low-Dose Peanut Oral Immunotherapy', 'Placebo', 'peanut oral immunotherapy (OIT', 'peanut OIT with a maintenance dose of 125 to 250 mg peanut protein or placebo']","['QOL', 'proportion of children tolerating 300 mg or more peanut protein at oral food challenge (OFC', 'occurrence of adverse events (AEs), immunologic changes, and QOL before and after OIT and BOT during OIT', 'peanut-specific IgG 4  levels', 'efficacy, safety, immunologic parameters, quality of life (QOL), and burden of treatment (BOT', 'Efficacy, Safety, and Quality of Life', 'peanut-specific IL-4, IL-5, IL-10, and IL-2 production by PBMCs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0033268'}]",62.0,0.659824,"There was no significant difference between the groups in the occurrence of AE-related dropouts or in the number, severity, and treatment of objective AEs.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Blumchen', 'Affiliation': 'Department of Children and Adolescent Medicine, Division of Pneumology, Allergology and Cystic fibrosis, University Hospital Frankfurt, Frankfurt am Main, Germany; Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address: katharina.bluemchen@kgu.de.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Trendelenburg', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ahrens', 'Affiliation': 'Children\'s Hospital ""Altona"", Hamburg, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Gruebl', 'Affiliation': 'Department of Pediatrics, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Eckard', 'Initials': 'E', 'LastName': 'Hamelmann', 'Affiliation': ""Department of Pediatrics, Allergy Center, Ruhr-University Bochum, Bochum, Germany; Children's Center Bethel, EvKB, Bielefeld, Germany.""}, {'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Hansen', 'Affiliation': 'Department of Pediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Heinzmann', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, University Medical Center, Medical Faculty, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Nemat', 'Affiliation': 'Department of Pediatrics, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holzhauser', 'Affiliation': 'Paul-Ehrlich-Institut, Division of Allergology, Langen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Roeder', 'Affiliation': 'Paul-Ehrlich-Institut, Division of Allergology, Langen, Germany; Institute for Product Quality (IFP), Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hartmann', 'Affiliation': 'Sphingotec, Hennigsdorf, Germany.'}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Niggemann', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2018.10.048']
1116,30762318,A comparison of the effects of mirror therapy and phantom exercises on phantom limb pain,"Background/aim


Although mirror therapy (MT) and phantom exercises (PE) have been shown to reduce pain, the efficacy of these methods in terms of pain, quality of life (QoL), and psychological status (PS) has not been investigated and compared to date. The aim of this study was to determine whether there is any difference between MT and PE in the treatment of phantom limb pain (PLP).
Materials and methods


Forty unilateral transtibial amputees (aged 18–45 years) participated in this study. The subjects were randomly divided into ‘MT group’ and ‘PE group’. QoL was assessed using Short-Form 36 (SF-36), psychological status using the Beck depression inventory (BDI), and pain intensity using a visual analog scale (VAS), before and at the end of the program, and on the 3rd and 6th months thereafter.
Results


All assessments for all parameters improved significantly in both groups (P < 0.05). Comparison of the two groups revealed a significant difference in changes for VAS and BDI in all measurements, and in pre- and posttreatment scores for all SF-36 parameters (except for Role-Emotional) in favor of the MT group (P < 0.05).
Conclusion


While pain intensity decreased and QoL and PS improved in both the MT and PE groups, these improvements were greater in the MT group.",2019,"Comparison of the two groups revealed a significant difference in changes for VAS and BDI in all measurements, and in pre- and posttreatment scores for all SF-36 parameters (except for Role-Emotional) in favor of the MT group (P < 0.05).
","['Materials and methods\n\n\nForty unilateral transtibial amputees (aged 18–45 years', 'phantom limb pain (PLP']","['MT and PE', 'mirror therapy and phantom exercises', 'mirror therapy (MT) and phantom exercises (PE']","['QoL and PS', 'pain, quality of life (QoL), and psychological status (PS', 'Short-Form 36 (SF-36), psychological status using the Beck depression inventory (BDI), and pain intensity using a visual analog scale (VAS', 'QoL', 'pain intensity', 'phantom limb pain', 'VAS and BDI']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002695', 'cui_str': 'Amputees'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031315', 'cui_str': 'Phantom Sensation'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282611', 'cui_str': 'Phantoms, Imaging'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0031315', 'cui_str': 'Phantom Sensation'}]",40.0,0.0786272,"Comparison of the two groups revealed a significant difference in changes for VAS and BDI in all measurements, and in pre- and posttreatment scores for all SF-36 parameters (except for Role-Emotional) in favor of the MT group (P < 0.05).
","[{'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Anaforoğlu Külünkoğlu', 'Affiliation': ''}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Erbahçeci', 'Affiliation': ''}, {'ForeName': 'Afra', 'Initials': 'A', 'LastName': 'Alkan', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-1712-166']
1117,30740297,Denosumab versus zoledronic acid in cases of surgically unsalvageable giant cell tumor of bone: A randomized clinical trial.,"Background


Although denosumab has been approved as an antiresorptive agent for giant cell tumor of bone, its efficacy has not been proven.
Objectives


To compare the efficacy and safety of denosumab and zoledronic acid treatment in patients with surgically unsalvageable giant cell tumor of bone.
Methods


A total of 250 patients with surgically unsalvageable giant cell tumor of bone were included in this randomized clinical trial. Patients received either subcutaneous denosumab (DB group; 120 mg per 4 weeks plus an additional 120 mg on days 8 and 15;  n  = 125) or intravenous zoledronic acid (ZA group; 4 mg per 4 weeks;  n  = 125) for six cycles. Disease status, clinical benefits, treatment-emergent adverse effects, overall survival, and cost of treatment were evaluated during the follow-up period. Statistical significance was determined using 95% confidence intervals.
Results


Denosumab and zoledronic acid had similar tumor responses ( p  = 0.18) and clinical benefits ( p  = 0.476). Disease progression was observed in fewer patients in the DB group (1%) than ZA group (2%). Denosumab caused fatigue ( p  = 0.0004) and back pain ( p  < 0.0001), while zoledronic acid caused hypocalcemia ( p  < 0.0001), flu-like symptoms ( p  = 0.021), hypotension ( p  = 0.021), and hypokalemia ( p  = 0.021). Denosumab treatment was markedly more expensive than zoledronic acid treatment ( p  < 0.0001). The cost to manage treatment-emergent adverse effects was higher for the ZA group than the DB group ( p  = 0.0425). Overall survival was the same for both treatments ( p  = 0.066).
Conclusions


Denosumab is a safe but costly alternative to zoledronic acid for treatment of surgically unsalvageable giant cell tumor of bone.",2019,"Denosumab caused fatigue ( p  = 0.0004) and back pain ( p  < 0.0001), while zoledronic acid caused hypocalcemia ( p  < 0.0001), flu-like symptoms ( p  = 0.021), hypotension ( p  = 0.021), and hypokalemia ( p  = 0.021).","['250 patients with surgically unsalvageable giant cell tumor of bone', 'patients with surgically unsalvageable giant cell tumor of bone', 'cases of surgically unsalvageable giant cell tumor of bone']","['Denosumab', 'zoledronic acid', 'denosumab and zoledronic acid', 'subcutaneous denosumab (DB group; 120\u202fmg per 4 weeks plus an additional 120\u202fmg on days 8 and 15;  n \u202f=\u202f125) or intravenous zoledronic acid (ZA group; 4\u202fmg per 4 weeks;  n \u202f=\u202f125) for six cycles', 'Denosumab and zoledronic acid', 'ZA', 'denosumab']","['back pain', 'fatigue', 'flu-like symptoms', 'Disease progression', 'hypotension', 'zoledronic acid caused hypocalcemia', 'Overall survival', 'clinical benefits', 'Disease status, clinical benefits, treatment-emergent adverse effects, overall survival, and cost of treatment', 'hypokalemia', 'cost to manage treatment-emergent adverse effects', 'efficacy and safety']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206638', 'cui_str': 'Giant Cell Tumor of Bone'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms (finding)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",250.0,0.157412,"Denosumab caused fatigue ( p  = 0.0004) and back pain ( p  < 0.0001), while zoledronic acid caused hypocalcemia ( p  < 0.0001), flu-like symptoms ( p  = 0.021), hypotension ( p  = 0.021), and hypokalemia ( p  = 0.021).","[{'ForeName': 'Shenglong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, No 44 of Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province 110042, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, No 44 of Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province 110042, China.'}, {'ForeName': 'Qiankun', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, No 44 of Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province 110042, China.'}]",Journal of bone oncology,['10.1016/j.jbo.2019.100217']
1118,30765235,Comparison of conventional and laser-aided fiberotomy in relapse tendency of rotated tooth: A randomized controlled clinical trial.,"INTRODUCTION


The aim of the present study was to compare the tendency of mandibular incisor rotation relapse after conventional circumferential supracrestal fiberotomy (CSF) with Er,Cr:YSGG laser-aided CSF.
METHODS


In this three-arm parallel study, the patients with one lower incisor rotation greater than 30 degrees before treatment were selected. The patients were randomly assigned to three groups in a 1:1:1 ratio. Rotational relapse tendency was measured on a digitized model one month after arch wire removal. Probing depth, clinical crown height and pain levels were also measured.
RESULTS


A total of 46 patients were recruited. Relapse tendency in conventional CSF and laser-aided CSF groups were 5.09±1.59° and 4.87±2.08°, respectively, and significantly lower than 11.28±2.93° in the control group (P<0.001). Relapse tendency was not different between the conventional CSF and laser CSF groups. Probing depth, clinical crown height, and experienced pain levels exhibited negligible differences.
CONCLUSIONS


Er,Cr:YSGG laser-aided CSF in one month was as effective in reducing rotational relapse tendency of mandibular incisor teeth as conventional CSF.",2019,YSGG laser-aided CSF in one month was as effective in reducing rotational relapse tendency of mandibular incisor teeth as conventional CSF.,"['patients with one lower incisor rotation greater than 30 degrees before treatment were selected', 'relapse tendency of rotated tooth', 'A total of 46 patients were recruited']","['Er,Cr', 'conventional and laser-aided fiberotomy', 'conventional CSF and laser-aided CSF', 'conventional circumferential supracrestal fiberotomy (CSF) with Er,Cr:YSGG laser-aided CSF', 'YSGG laser-aided CSF']","['Probing depth, clinical crown height, and experienced pain levels', 'Probing depth, clinical crown height and pain levels', 'Rotational relapse tendency', 'Relapse tendency', 'mandibular incisor rotation relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0266071', 'cui_str': 'Rotation of tooth (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}]","[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",46.0,0.0238815,YSGG laser-aided CSF in one month was as effective in reducing rotational relapse tendency of mandibular incisor teeth as conventional CSF.,"[{'ForeName': 'Amir Farhang', 'Initials': 'AF', 'LastName': 'Miresmæili', 'Affiliation': 'Department of Orthodontics, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mollabashi', 'Affiliation': 'Department of Orthodontics, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Gholami', 'Affiliation': 'Department of Periodontics, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran; Department of Periodontics, Dentofacial Deformities Research Center, Dental Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farhadian', 'Affiliation': 'Department of Biostatistics, School of Public Health and Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Rezaei-Soufi', 'Affiliation': 'Restorative Department, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Javanshir', 'Affiliation': 'Department of Orthodontics, Anzali International Campus, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Malekshoar', 'Affiliation': 'Department of Orthodontics, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: miladmalekshoar@rocketmail.com.'}]",International orthodontics,['10.1016/j.ortho.2019.01.018']
1119,31654674,Experimental empathy induction promotes oxytocin increases and testosterone decreases.,"Oxytocin and testosterone coordinate adaptive social behaviors with stimuli in the environment. Administration of oxytocin and testosterone is associated with increased and reduced indicators of empathy, respectively, but how levels of these hormones are jointly affected by naturalistic empathy-inducing stimuli remains unclear. In this study, salivary oxytocin and testosterone levels were measured in 173 healthy adults before and after watching a video involving a gravely ill child. Participants also completed questionnaires to assess psychological variables predicted to affect oxytocin reactivity (Autism-Spectrum Quotient, Interpersonal Reactivity Index, Empathy and Systemizing Quotients). On average, there was a 14% increase in oxytocin (p = 0.003) and 4% decrease in testosterone (p = 0.001) pre- to post-video. Opposite directional changes in hormone levels occurred together, as supported by a chi-square test (p < 0.001) and a circular statistics test (p < 0.05). Considered separately, psychological traits did not predict hormone levels or changes to any appreciable degree. However, oxytocin and testosterone changes were linked with empathy relative to systemizing such that: (1) 'Empathy Bias' was associated with a large oxytocin increase but little change in testosterone, while (2) 'Systemizing Bias' and 'Balance' between empathy and systemizing were associated with a decrease in testosterone but little change in oxytocin. These findings suggest that participants were divisible into 'high oxytocin responders' (relatively empathetic) and 'high testosterone responders' (balanced or systemizing-biased). These findings support a model of joint, opposite changes in oxytocin and testosterone under experimental empathy induction, with high, somewhat predictable, diversity in individual responses.",2020,"On average, there was a 14% increase in oxytocin (p = 0.003) and 4% decrease in testosterone (p = 0.001) pre-",['173 healthy adults before and after watching a video involving a gravely ill child'],"['oxytocin and testosterone', 'Oxytocin and testosterone']","['oxytocin reactivity (Autism-Spectrum Quotient, Interpersonal Reactivity Index, Empathy and Systemizing Quotients', 'oxytocin', ""testosterone, while (2) 'Systemizing Bias' and 'Balance"", 'hormone levels', 'salivary oxytocin and testosterone levels', 'testosterone']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",173.0,0.114196,"On average, there was a 14% increase in oxytocin (p = 0.003) and 4% decrease in testosterone (p = 0.001) pre-","[{'ForeName': 'Tanya L', 'Initials': 'TL', 'LastName': 'Procyshyn', 'Affiliation': 'Department of Biological Sciences, 8888 University Drive, Simon Fraser University, Burnaby V5A 1S6, Canada; Autism Research Centre, Department of Psychiatry, University of Cambridge, Cambridge CB2 8AH, UK.'}, {'ForeName': 'Neil V', 'Initials': 'NV', 'LastName': 'Watson', 'Affiliation': 'Department of Psychology, 8888 University Drive, Simon Fraser University, Burnaby V5A 1S6, Canada.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Crespi', 'Affiliation': 'Department of Biological Sciences, 8888 University Drive, Simon Fraser University, Burnaby V5A 1S6, Canada. Electronic address: crespi@sfu.ca.'}]",Hormones and behavior,['10.1016/j.yhbeh.2019.104607']
1120,30719774,Autologous platelet-rich plasma covering urethroplasty versus dartos flap in distal hypospadias repair: A prospective randomized study.,"OBJECTIVE


To compare the outcome and complication rate of the platelet-rich plasma applied as a coverage layer and dartos flap layer during primary repair of distal hypospadias.
METHODS


A prospective randomized study was carried out comprising 180 boys (age range 12-65 months) from October 2011 to December 2016 at Al-Azhar University Hospitals, Cairo, Egypt. A single surgeon carried out all urethroplasty. Patients were randomly divided into two groups: group A (tubularized incised plate urethroplasty with platelet-rich plasma coverage layer) and group B (ventral dartos flap). Complication rates were compared between two groups.
RESULTS


There was a significant difference in the occurrence of complications between the two groups. A total of 36 (20%) complications were recorded in 26 patients, just 12 (13.3%) reported in group A, but 24 (26.7%) complications were reported in group B. Urethrocutaneous fistula was observed in nine patients (10%) in group A, and 12 (13.3%) in group B. Partial glans dehiscence occurred in one patient in group A, and four patients in group B. No patient in group A had a superficial wound infection, compared with six patients in group B. One case of meatal stenosis and urethral stricture was recorded in each group, all of which were managed conservatively. The resultant urinary stream was single and good in 154 patients of both groups.
CONCLUSIONS


Platelet-rich plasma sheet might be considered as an alternative coverage layer for distal hypospadias repair, especially in the absence of a healthy layer.",2019,"One case of meatal stenosis and urethral stricture was recorded in each group, all of which were managed conservatively.","['180 boys (age range 12-65\xa0months) from October 2011 to December 2016 at Al-Azhar University Hospitals, Cairo, Egypt', '154 patients of both groups', 'distal hypospadias repair']","['group\xa0A (tubularized incised plate urethroplasty with platelet-rich plasma coverage layer) and group\xa0B (ventral dartos flap', 'Autologous platelet-rich plasma covering urethroplasty versus dartos flap']","['Complication rates', 'B. Partial glans dehiscence', 'occurrence of complications', 'superficial wound infection', 'Urethrocutaneous fistula', 'meatal stenosis and urethral stricture']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra (procedure)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0440926', 'cui_str': 'Dartos flap (substance)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound (morphologic abnormality)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0431750', 'cui_str': 'Stenosis of urinary meatus (disorder)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}]",180.0,0.0178328,"One case of meatal stenosis and urethral stricture was recorded in each group, all of which were managed conservatively.","[{'ForeName': 'Abdelaziz Yehya', 'Initials': 'AY', 'LastName': 'Mahmoud', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gouda', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Gamaan', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Baky Fahmy', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13912']
1121,31691253,"Evaluating NeuroSENSE for assessing depth of hypnosis during desflurane anesthesia: an adaptive, randomized-controlled trial.","PURPOSE


Processed electroencephalography (EEG) monitors support depth-of-hypnosis assessment during anesthesia. This randomized-controlled trial investigated the performance of the NeuroSENSE electroencephalography (EEG) monitor to determine whether its wavelet anesthetic value for central nervous system (WAV CNS ) index distinguishes consciousness from unconsciousness during induction of anesthesia (as assessed by the anesthesiologist) and emergence from anesthesia (indicated by patient responsiveness), and whether it correlates with changes in desflurane minimum alveolar concentration (MAC) during maintenance of anesthesia.
METHODS


EEG was collected using a fronto-temporal bilateral montage. The WAV CNS  was continuously recorded by the NeuroSENSE monitor, to which the anesthesiologist was blinded. Anesthesia was induced with propofol/remifentanil and maintained with desflurane, with randomized changes of -0.4, 0, or +0.4 MAC every 7.5 min within the 0.8-1.6 MAC range, if clinically acceptable to the anesthesiologist. During emergence from anesthesia, desflurane was stepped down by 0.2 MAC every five minutes.
RESULTS


Data from 75 patients with a median [interquartile range] age of 41[35-52] yr were obtained. The WAV CNS  distinguished consciousness from unconsciousness as assessed by the anesthesiologist, with area under the receiver operating characteristic curve of 99.5% (95% confidence interval [CI], 98.5 to 100.0) at loss of consciousness and 99.4% (95% CI, 98.5 to 100.0) at return of consciousness. Bilateral WAV CNS  changes correlated with desflurane concentrations, with -8.0 and -8.6 WAV CNS  units, respectively, per 1 MAC change in the 0.8-1.6 MAC range during maintenance of anesthesia and -10.0 and -10.5 WAV CNS  units, respectively, in the 0.4-1.6 MAC range including emergence from anesthesia.
CONCLUSION


The NeuroSENSE monitor can reliably discriminate between consciousness and unconsciousness, as assessed by the anesthesiologist, during induction of anesthesia and with a lower level of reliability during emergence from anesthesia. The WAV CNS  correlates with desflurane concentration but plateaus at higher concentrations, similar to other EEG monitors, which suggests limited utility to titrate higher concentrations of anesthetic vapour.
TRIAL REGISTRATION


clinicaltrials.gov, NCT02088671; registered 17 March, 2014.",2020,"The WAV CNS  distinguished consciousness from unconsciousness as assessed by the anesthesiologist, with area under the receiver operating characteristic curve of 99.5% (95% confidence interval [CI], 98.5 to 100.0) at loss of consciousness and 99.4% (95% CI, 98.5 to 100.0) at return of consciousness.",['75 patients with a median [interquartile range] age of 41[35-52] yr were obtained'],"['propofol/remifentanil', 'NeuroSENSE electroencephalography (EEG', 'desflurane', 'desflurane anesthesia']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",[],,0.151689,"The WAV CNS  distinguished consciousness from unconsciousness as assessed by the anesthesiologist, with area under the receiver operating characteristic curve of 99.5% (95% confidence interval [CI], 98.5 to 100.0) at loss of consciousness and 99.4% (95% CI, 98.5 to 100.0) at return of consciousness.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Görges', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada. mgorges@bcchr.ca.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'West', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Cooke', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Pi', 'Affiliation': 'Department of Statistics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Rollin F', 'Initials': 'RF', 'LastName': 'Brant', 'Affiliation': ""BC Children's Hospital Research Institute, 950 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada.""}, {'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'Dumont', 'Affiliation': ""BC Children's Hospital Research Institute, 950 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada.""}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Ansermino', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Merchant', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01522-5']
1122,30475043,A pilot randomized controlled trial evaluating a web-based training program on pediatric medical traumatic stress and trauma-informed care for emergency department staff.,"This pilot parallel group superiority randomized controlled trial investigated the efficacy and acceptability of a web-based training program on pediatric medical traumatic stress and trauma-informed care (Australian and New Zealand Clinical Trials Registry number: ACTRN12617001148369). Eligibility criteria for this study included being a nurse or physician working in an ED in Australia or New Zealand, being fluent in English and having Internet access. Emergency department (ED) staff (N = 71) were randomly assigned into the training (n = 32) or control group n = 39). We hypothesized that compared to the control group, ED staff in the training group would show a greater improvement in knowledge of pediatric medical traumatic stress 1-week post training and that improvement would be maintained at 1-month post training. At baseline participants completed a brief questionnaire assessing knowledge of pediatric medical traumatic stress. The training group then completed the 15-min online training program. The knowledge questionnaire was readministered to all participants' 1 week and 1 month posttraining, after which the control group gained access to the training. Acceptability was based on a program evaluation measure utilizing quantitative and qualitative items. The training group had significantly greater knowledge following training and at follow-up than the control group (p > .001, f = .42) and reported high rates of satisfaction. The results demonstrated an improvement in ED staff knowledge as a result of the training and provide preliminary support for the efficacy and acceptability of brief online training to improve the knowledge of ED staff interested in pediatric medical traumatic stress and trauma-informed care. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"The training group had significantly greater knowledge following training and at follow-up than the control group (p > .001, f = .42) and reported high rates of satisfaction.","['Eligibility criteria for this study included being a nurse or physician working in an ED in Australia or New Zealand, being fluent in English and having Internet access', 'pediatric medical traumatic stress and trauma-informed care for emergency department staff', 'Emergency department (ED) staff (N = 71', 'pediatric medical traumatic stress and trauma-informed care (Australian and New Zealand Clinical Trials Registry number']",['web-based training program'],"['rates of satisfaction', 'knowledge of pediatric medical traumatic stress', 'Acceptability', 'efficacy and acceptability']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",71.0,0.0257917,"The training group had significantly greater knowledge following training and at follow-up than the control group (p > .001, f = .42) and reported high rates of satisfaction.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hoysted', 'Affiliation': 'School of Psychological Sciences and Monash Institute of Cognitive and Clinical Neuroscience, Monash University.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jobson', 'Affiliation': 'School of Psychological Sciences and Monash Institute of Cognitive and Clinical Neuroscience, Monash University.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Alisic', 'Affiliation': 'Monash University Accident Research Centre, Monash University.'}]",Psychological services,['10.1037/ser0000247']
1123,30768429,Using Electronic Clinical Decision Support in Patient-Centered Medical Homes to Improve Management of Diabetes in Primary Care: The DECIDE Study.,"This prospective, randomized, real-world study aimed to examine the impact of electronic health record-based clinical decision support (CDS) tools on the management of diabetes in small- to medium-sized primary care practices participating in Delaware's patient-centered medical home project. Overall, use of CDS systems was associated with greater reductions from baseline in hemoglobin A1c and low-density lipoprotein cholesterol, and more patients achieving treatment goals. Physicians and staff reported that the CDS toolkit empowered them to be more involved in clinical decision-making, thereby helping to improve diabetes care. However, all cited significant barriers to fully implementing team-based CDS, predominantly involving time and reimbursement.",2019,"Overall, use of CDS systems was associated with greater reductions from baseline in hemoglobin A1c and low-density lipoprotein cholesterol, and more patients achieving treatment goals.","['Patient-Centered Medical Homes to Improve Management of Diabetes in Primary Care', ""diabetes in small- to medium-sized primary care practices participating in Delaware's patient-centered medical home project""]",['electronic health record-based clinical decision support (CDS) tools'],['hemoglobin A1c and low-density lipoprotein cholesterol'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2713310', 'cui_str': 'Medical Home'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0011198', 'cui_str': 'Delaware'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",,0.0188189,"Overall, use of CDS systems was associated with greater reductions from baseline in hemoglobin A1c and low-density lipoprotein cholesterol, and more patients achieving treatment goals.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Delaware Valley Outcomes Research, Newark, Delaware (Dr Gill and Ms Turk); independent consultant (Dr Kucharski); Sanofi US, Inc, Bridgewater, New Jersey (Dr Pan); and Regeneron Pharmaceuticals Inc, Tarrytown, New York (Dr Wei).'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kucharski', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Turk', 'Affiliation': ''}, {'ForeName': 'Chunshen', 'Initials': 'C', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ''}]",The Journal of ambulatory care management,['10.1097/JAC.0000000000000267']
1124,30641335,Effects of a brief pain and smoking cessation intervention in adults with chronic pain: A randomized controlled trial.,"Tobacco cigarette smokers with comorbid chronic pain experience greater difficulty quitting smoking relative to those without chronic pain. A brief smoking cessation intervention was developed to address smoking in the context of chronic pain to increase the intention to engage in smoking cessation treatment. The primary aim of this randomized controlled trial was to investigate the effects of a brief pain and smoking (BPS) cessation intervention on the willingness to consider quitting smoking in adults with chronic pain seeking treatment in a pain specialty outpatient clinic. Subjects randomized to the BPS intervention were 7.5 times more likely to endorse willingness to consider quitting smoking. Subjects who received the BPS intervention were also greater than 2.5 times more likely to report an interest in learning about cessation programs, and nearly 5 times more likely to endorse willingness to consider participating in an intensive smoking cessation program. Moreover, subjects who received the BPS intervention evinced a trend-level reduction in perceived difficulty of quitting smoking. These results contribute to a growing multidisciplinary literature examining pain-smoking interrelations and suggest that smokers with chronic pain may become more willing to consider engaging a cessation attempt as awareness increases about how continued smoking may interfere with the clinical outcomes of pain treatment. These results are also consistent with clinical practice guidelines for promoting intention to quit among smokers currently unwilling to engage a quit attempt by incorporating strategies aimed at identifying ambivalence about the continued use of tobacco.",2019,"Subjects who received the BPS intervention were also greater than 2.5 times more likely to report an interest in learning about cessation programs, and nearly 5 times more likely to endorse willingness to consider participating in an intensive smoking cessation program.","['adults with chronic pain seeking treatment in a pain specialty outpatient clinic', 'Tobacco cigarette smokers with comorbid chronic pain experience greater difficulty quitting smoking relative to those without chronic pain', 'adults with chronic pain']","['smoking cessation intervention', 'brief pain and smoking cessation intervention', 'brief pain and smoking (BPS) cessation intervention', 'BPS intervention']","['endorse willingness to consider quitting smoking', 'quitting smoking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0159413,"Subjects who received the BPS intervention were also greater than 2.5 times more likely to report an interest in learning about cessation programs, and nearly 5 times more likely to endorse willingness to consider participating in an intensive smoking cessation program.","[{'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Hooten', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic College of Medicine, Rochester, MN, United States. Electronic address: hooten.william@mayo.edu.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'LaRowe', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, United States.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Zale', 'Affiliation': 'Department of Psychology, Binghamton University, Binghamton, NY, United States.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Ditre', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, United States.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Warner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic College of Medicine, Rochester, MN, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.11.040']
1125,30759295,Feasibility of a Single-Subject Protocol to Shift Young Children's Sleep Schedules.,"The objective of this study is to describe children's adherence to changing sleep schedules within a small-scale, single-subject, at-home sleep manipulation experiment. Subjects were six healthy children (male = 4, ages 6-8). Children underwent: baseline, a 7-day self-selected sleep pattern; Condition A1, a 3- to 12-day stabilized sleep pattern (assigned time into/out of bed set at baseline averages); Condition B, a 3- to 12-day phase-delayed sleep pattern (time into/out of bed 2 h later than Condition A); and Condition A2, a 3- to 7-day return-to-stabilized sleep pattern (time into/out of bed at Baseline averages, identical to Condition A1). All children completed conditions. Per parent report, adherence to assigned time into/out of bed was good; sleep onset/offset adherence was variable. Within this small-scale, short-term sleep manipulation, children effectively got into/out of bed at assigned times despite manipulating sleep schedules by 2 h. However, they struggle to shift their sleep onset and offset times to match the time they were in bed.",2019,"Within this small-scale, short-term sleep manipulation, children effectively got into/out of bed at assigned times despite manipulating sleep schedules by 2 h.","[""Shift Young Children's Sleep Schedules"", 'Subjects were six healthy children (male\u2009=\u20094, ages 6-8']","['Single-Subject Protocol', '7-day self-selected sleep pattern; Condition A1, a 3- to 12-day stabilized sleep pattern (assigned time into/out of bed set at baseline averages); Condition B, a 3- to 12-day phase-delayed sleep pattern (time into/out of bed 2\xa0h later than Condition A); and Condition A2, a 3- to 7-day return-to-stabilized sleep pattern']",[],"[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}]",[],6.0,0.0125283,"Within this small-scale, short-term sleep manipulation, children effectively got into/out of bed at assigned times despite manipulating sleep schedules by 2 h.","[{'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Fisher', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, 700 Children's Dr, Columbus, OH, 43205, USA. Rachel.Fisher@nationwidechildrens.org.""}, {'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ""Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital and Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Janicke', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, 1225 Center Dr, Gainesville, FL, 32603, USA.'}]",Journal of clinical psychology in medical settings,['10.1007/s10880-019-09604-8']
1126,30314739,Evaluation of a nurse-led intervention program in heart failure: A randomized trial.,"BACKGROUND AND OBJECTIVE


Several trials have evaluated the effect of disease management programs in heart failure (HF) with diverse results. The aim of this study was to develop a simple nurse-led clinic intervention program for patients with HF and assess whether this intervention positively affects the prognosis of patients, their care costs and perceived quality of life (QoL).
METHODS


Between 2011 and 2013, 127 patients with reduced ejection fraction were prospectively randomly allocated (1:2) to standard care or intervention program. Primary composite endpoint was all-cause mortality and hospital readmissions. Secondary endpoints were all-cause mortality, all-cause hospital readmissions, readmissions for HF, time to first readmission and QoL improvements assessed by ""Minnesota Living with Heart Failure Questionnaire"" (MLHFQ). An intention-to-treat analysis was performed.
RESULTS


After a median follow-up of 2-years, no differences were found in the primary composite endpoint. Likewise, there were no differences between groups in the predefined secondary endpoints of mortality and readmissions from any cause. However, in the intervention group, readmissions for HF were significantly reduced (35% vs. 18%; p=0.04) and QoL significantly improved (MLHFQ±SD: 2.29±14 vs. 10.9±14.75; p=0.04).
CONCLUSIONS


In patients with HF, the use of a nurse-led intervention program significantly improves perceived QoL and reduce HF hospital readmissions.",2019,"In patients with HF, the use of a nurse-led intervention program significantly improves perceived QoL and reduce HF hospital readmissions.","['127 patients with reduced ejection fraction', 'Between 2011 and 2013', 'heart failure', 'patients with HF']","['standard care or intervention program', 'nurse-led intervention program']","['readmissions for HF', 'mortality and readmissions', 'cause mortality and hospital readmissions', 'QoL', 'cause mortality, all-cause hospital readmissions, readmissions for HF, time to first readmission and QoL improvements assessed by ""Minnesota Living with Heart Failure Questionnaire"" (MLHFQ', 'care costs and perceived quality of life (QoL', 'perceived QoL and reduce HF hospital readmissions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",127.0,0.0973912,"In patients with HF, the use of a nurse-led intervention program significantly improves perceived QoL and reduce HF hospital readmissions.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ortiz-Bautista', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Morán-Fernández', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Díaz-García', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Delgado-Nicolás', 'Affiliation': 'Los Angeles Primary Care Center, Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Ponz-de Antonio', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Rodríguez-Chaverri', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Mª Dolores', 'Initials': 'MD', 'LastName': 'García-Cosio', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de Juan-Bagudá', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lora-Pablos', 'Affiliation': 'Clinical Research Unit (I+12), Hospital Universitario 12 de Octubre, CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Escribano-Subías', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Facultad de Medicina, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Bueno', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Facultad de Medicina, Universidad Complutense, Madrid, Spain; Centro Nacional de investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Arribas-Ynsaurriaga', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Facultad de Medicina, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Delgado-Jiménez', 'Affiliation': 'Department of Cardiology, Hospital Universitario 12 de Octubre, CIBER Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Facultad de Medicina, Universidad Complutense, Madrid, Spain. Electronic address: jdelgado.hdoc@salud.madrid.org.'}]",Medicina clinica,['10.1016/j.medcli.2018.08.005']
1127,30640504,Prevention of alcohol use in older teens: A randomized trial of an online family prevention program.,"This study examines effects of a randomized controlled trial for an online, family-based prevention program for older teens, Smart Choices 4 Teens, on alcohol use and related outcomes. Families (N = 411; teen age M = 16.4, SD = 0.5) were randomly assigned to the intervention or control condition in 2014-2015. Both intent to treat (ITT) and dosage models were conducted. ITT models: At the 6-month follow-up, teens in the experimental condition reported fewer friends who had been drunk, and parents in the experimental group reported more communication about social host laws. At the 12-month follow-up, parents in the experimental condition reported consuming fewer drinks than parents in the control group. Dosage models: At the 6-month follow-up, dosage was inversely related to teen drinking in the past 6 months or 30 days, frequency of teen drinking during the past 6 months and 30 days, drinks consumed by teens over the past 6 months, teen drunkenness and binge-drinking during the past 30 days, teen reported communication about safe drinking and positively related to parent and teen reported communication about social host laws. At 12 months, dosage was inversely related to teen alcohol use, frequency of teen drinking over the past 30 days, drinks consumed by teens over the past 6 months and 30 days, and teen drunkenness over the past 6 months. Results suggest that Smart Choices 4 Teens is beneficial for families. Dissemination and implementation strategies that motivate completion of program content will improve outcomes related to older teens' alcohol use. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"At the 12-month follow-up, parents in the experimental condition reported consuming fewer drinks than parents in the control group.","['Families (N = 411; teen age M = 16.4, SD = 0.5', 'older teens', 'older teens, Smart Choices 4 Teens, on alcohol use and related outcomes']","['online family prevention program', 'online, family-based prevention program']","['alcohol use, frequency of teen drinking']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0684314', 'cui_str': 'Adolescent Alcohol Consumption'}]",,0.0150518,"At the 12-month follow-up, parents in the experimental condition reported consuming fewer drinks than parents in the control group.","[{'ForeName': 'Hilary F', 'Initials': 'HF', 'LastName': 'Byrnes', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation.'}, {'ForeName': 'Brenda A', 'Initials': 'BA', 'LastName': 'Miller', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Grube', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bourdeau', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., Golden.'}, {'ForeName': 'Meme', 'Initials': 'M', 'LastName': 'Wang-Schweig', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation.'}, {'ForeName': 'W Gill', 'Initials': 'WG', 'LastName': 'Woodall', 'Affiliation': 'Klein Buendel, Inc.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000442']
1128,30761846,Comparison of early and long term outcomes of open Lichtenstein repair and totally extraperitoneal herniorrhaphy for primary inguinal hernias,"Background/aim


Inguinal  hernia  repair  is  one  of  the  most  common  surgical  procedures  worldwide.  There  is  still  controversy  over  which method has the best postoperative results. The aim of this study was to compare early and late postoperative results of laparoscopic totally extraperitoneal herniorrhaphy (TEP) and open Lichtenstein herniorrhaphy (OLR).
Materials and methods


The study was conducted in a randomized prospective manner and it was concluded with 302 patients (147 cases  in  TEP  group  and  155  cases  in  OLR  group).  All  procedures  were  performed  by  two  experienced  surgeons  in  both  open  and  laparoscopic inguinal hernia repair.
Results


The groups were similar in terms of age, sex, and types of inguinal hernia according to Nyhuss classification. The mean operation time was shorter in TEP group with 49.2 ± 15.5 min vs 54.3 ± 14.6 min in OLR group (P = 0.004). The mean length of hospital stay was significantly shorter in TEP group (P = 0.001). The mean postoperative visual analogue scale score was significantly lower in TEP group. With a mean follow-up of 40.95 months, the recurrence rates were similar in both groups with a rate of 4.3%. In terms of chronic pain, TEP group has better results than OLR with 3.4% vs 25.2%, respectively (P = 0.001).
Conclusion


In experienced hands, TEP procedure has better early and late postoperative results than OLR, whereas recurrence rates are similar.",2019,The mean length of hospital stay was significantly shorter in TEP group (P = 0.001).,"['primary inguinal hernias', '302 patients (147 cases  in  TEP  group  and  155  cases  in  OLR  group']","['TEP', 'open Lichtenstein repair and totally extraperitoneal herniorrhaphy', 'All  procedures  were  performed  by  two  experienced  surgeons  in  both  open  and  laparoscopic inguinal hernia repair', 'laparoscopic totally extraperitoneal herniorrhaphy (TEP) and open Lichtenstein herniorrhaphy (OLR']","['mean operation time', 'mean length of hospital stay', 'mean postoperative visual analogue scale score', 'recurrence rates']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",302.0,0.0680419,The mean length of hospital stay was significantly shorter in TEP group (P = 0.001).,"[{'ForeName': 'Barış', 'Initials': 'B', 'LastName': 'Sevinç', 'Affiliation': ''}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Damburacı', 'Affiliation': ''}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Güner', 'Affiliation': ''}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Karahan', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-1803-94']
1129,30762087,Acute reconstruction results in less sick-leave days and as such fewer indirect costs to the individual and society compared to delayed reconstruction for ACL injuries.,"PURPOSE


To compare the total number of sick-leave days caused by the knee injury from the day of injury and over the first year between acute (within 8 days) and delayed (6-10 weeks) anterior cruciate ligament reconstruction (ACLR) and also assess other clinical outcomes during this period.
METHODS


Seventy patients with an acute ACL injury and Tegner level of 6 or more were randomized to acute (within 8 days) or delayed (after 6-10 weeks) ACLR. Patient-reported outcomes; objective IKDC and manual stability measurements were assessed at 6 and 12 months. With data from the Swedish Social Insurance Agency (Försäkringskassan) information about the number of sick-leave days due to the knee injury over the following 12 months was collected and compared between the two groups.
RESULTS


Seventy-one percent received compensation for sick leave (26 in the acute versus 23 in the delayed group). The mean number of sick-leave days for the acute group was significantly lower (M = 56.9, SD = 36.4) compared to the delayed group (M = 88.5, SD = 50.2), p < 0.05. The acute group was also significantly stronger in flexion in both slow and fast angle velocities according to Biodex ® . No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
CONCLUSION


Acute and delayed ACLR provided comparable clinical outcomes after 12 months. Acute reconstruction resulted in less sick-leave days and as such fewer indirect costs to the individual and society. These findings suggest that if patients requiring ACLR can be identified early and ACLR can be performed in the acute phase, socioeconomic costs can potentially be reduced by minimizing time off work.
LEVEL OF EVIDENCE


II.",2020,"No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
","['With data from the Swedish Social Insurance Agency ', 'Seventy patients with an acute ACL injury and Tegner level of 6 or more were randomized to acute (within 8\xa0days) or delayed (after 6-10\xa0weeks']",['anterior cruciate ligament reconstruction (ACLR'],"['flexion in both slow and fast angle velocities', 'compensation for sick leave', 'total number of sick-leave days', 'outcomes; objective IKDC and manual stability measurements', 'mean number of sick-leave days']","[{'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",70.0,0.0674861,"No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'von Essen', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden. Christoffer.vonessen@gmail.com.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'McCallum', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Barenius', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05397-3']
1130,30737047,Haptoglobin phenotype influences the effectiveness of diet-induced weight loss in middle-age abdominally obese women with metabolic abnormalities.,"BACKGROUND & AIMS


Haptoglobin (Hp) is associated with risks of obesity and cardiometabolic dysfunction; however, the role of the Hp phenotype in diet-induced weight loss remains to be elucidated. This study investigated whether the Hp phenotype contributes to inter-individual variations in body weight reduction as well as changes in the metabolic profile.
METHODS


Secondary data analysis from a randomized controlled trial. In total, 151 abdominally obese Taiwanese women with ≥2 metabolic components were randomized to each of four dietary programs [calorie restriction (CR), calorie restriction plus fish oil supplementation (CRF), calorie restricted meal replacement (CRMR), and calorie restricted meal replacement with fish oil supplementation (CRMRF)] for 12 weeks. Abdominal obesity was defined as a waist circumference (WC) ≥ 80 cm in women. Hp phenotyping was performed by plasma gel electrophoresis.
RESULTS


The prevalence of the Hp 1-1, 2-1, and 2-2 phenotypes were 12.58%, 41.06% and 46.35%, respectively. The mean age was 50.59 ± 12.22 years, and mean reduction in the percent body weight was 4.7% ± 3.8%. The Hp 1-1 phenotype exhibited significant decreases in the WC, body fat mass, plasma insulin levels, free hemoglobin and homeostatic model assessment of insulin resistance (HOMA-IR) compared to the Hp 2-1 or Hp 2-2 phenotypes after adjusting for the baseline age, WC, metabolic syndrome (MetS), and dietary programs (all adjusted p < 0.05). A greater improvement in the prevalence of central obesity and, to a lesser extent, MetS was also found in women with the Hp 1-1 phenotype.
CONCLUSIONS


Obese women with the Hp 1-1 phenotype might obtain greater benefits in terms of reducing abdominal fat and improving insulin sensitivity in response to hypocaloric diet-induced weight reduction. The findings from this study support potential gene-diet interactions affecting weight loss. This trial was registered at ClinicalTrials.gov as NCT01768169.
CLINICAL TRIAL REGISTRY


This trial was registered at ClinicalTrials.gov as NCT01768169.",2020,"The Hp 1-1 phenotype exhibited significant decreases in the WC, body fat mass, plasma insulin levels, free hemoglobin and homeostatic model assessment of insulin resistance (HOMA-IR) compared to the Hp 2-1 or Hp 2-2 phenotypes after adjusting for the baseline age, WC, metabolic syndrome (MetS), and dietary programs (all adjusted p < 0.05).","['151 abdominally obese Taiwanese women with ≥2 metabolic components', 'Obese women', 'middle-age abdominally obese women with metabolic abnormalities']","['dietary programs [calorie restriction (CR), calorie restriction plus fish oil supplementation (CRF), calorie restricted meal replacement (CRMR), and calorie restricted meal replacement with fish oil supplementation (CRMRF', 'Haptoglobin']","['prevalence of central obesity', 'weight loss', 'Abdominal obesity', 'WC, body fat mass, plasma insulin levels, free hemoglobin and homeostatic model assessment of insulin resistance (HOMA-IR']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026062', 'cui_str': 'Middle Age'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",151.0,0.117505,"The Hp 1-1 phenotype exhibited significant decreases in the WC, body fat mass, plasma insulin levels, free hemoglobin and homeostatic model assessment of insulin resistance (HOMA-IR) compared to the Hp 2-1 or Hp 2-2 phenotypes after adjusting for the baseline age, WC, metabolic syndrome (MetS), and dietary programs (all adjusted p < 0.05).","[{'ForeName': 'Kelvin Yohanes', 'Initials': 'KY', 'LastName': 'Tang', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Metabolism and Obesity Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Tsai-Mu', 'Initials': 'TM', 'LastName': 'Cheng', 'Affiliation': 'Graduate Institute of Translational Medicine, College of Medical Sciences and Technology, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chyi-Huey', 'Initials': 'CH', 'LastName': 'Bai', 'Affiliation': 'Department of Public Health, College of Medicine, Taipei Medical University, Taipei, Taiwan; Department of Public Health, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jung-Su', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Metabolism and Obesity Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan; Nutrition Research Center, Taipei Medical University Hospital, Taipei, Taiwan; Chinese Taipei Society for the Study of Obesity, CTSSO, Taipei, Taiwan. Electronic address: susanchang@tmu.edu.tw.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.01.019']
1131,31694478,How specific is cognitive change? A randomized controlled trial comparing brief cognitive and mindfulness interventions for depression.,"Objective : There is a debate in psychotherapy research as to whether different kinds of psychotherapy work through specific mechanisms of change. Particularly, it is questioned whether cognitive change is specific to cognitive therapy. This study aimed to answer this question by comparing a brief cognitive intervention with an active comparison intervention (i.e., brief mindfulness-based intervention) and by following strict methodological guidelines.  Method:  72 currently depressed outpatients were randomized to either cognitive intervention ( n  = 39) or mindfulness-based intervention ( n  = 33). Automatic thoughts ( negative self-statements ,  well-being , and  self-confidence ), dysfunctional attitudes ( performance evaluation  and  approval by others ) and depressive symptoms were assessed before and six times during treatment. Within-person and between-person mediation effects were analyzed using multilevel structural equation modeling.  Results : There was no difference in cognitive change between the interventions. Negative self-statements and performance evaluations were significant mediators of the within-person effect of time on depressive symptoms, while the three other cognitive variables did not change. Conversely, change in depressive symptoms also mediated within-person cognitive change.  Conclusion : Cognitive change seems to be a general rather than a specific mechanism of change. However, the mutual impact of cognitive and depressive change does not support a unidirectional causal model.",2020,There was no difference in cognitive change between the interventions.,[],"['cognitive intervention with an active comparison intervention (i.e., brief mindfulness-based intervention', 'cognitive intervention ( n \u2009=\u200939) or mindfulness-based intervention', 'cognitive and mindfulness interventions']","['depressive symptoms', 'Automatic thoughts ( negative self-statements ,  well-being , and  self-confidence ), dysfunctional attitudes ( performance evaluation  and  approval by others ) and depressive symptoms', 'cognitive change']",[],"[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",72.0,0.0416822,There was no difference in cognitive change between the interventions.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hofheinz', 'Affiliation': 'Institute of Psychology, University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Reder', 'Affiliation': 'Institute of Psychology, University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, German.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1685138']
1132,30640148,Which behavior change techniques help young adults reduce binge drinking? A pilot randomized clinical trial of 5 text message interventions.,"Text message (SMS) interventions can reduce binge drinking in young adults, but optimal behavior change techniques (BCTs) remain unknown. The present study tests the acceptability and preliminary efficacy of different combinations of SMS-delivered BCTs. 149 young adults who screened positive for hazardous drinking completed a baseline survey in the Emergency Department. For the following 2-weeks, on days they typically drank (1 to 3 days per week), participants received ecological momentary assessments (EMA) of drinking plans and desire to get drunk; the next day they were prompted to report recall of number of drinks consumed the prior day. Participants who responded to at least 50% these EMA (N = 127) were randomized to one of five 12-week interventions: Cued Self-Monitoring (TRACK); Drinking Intentions Feedback (PLAN); Drinking Performance Feedback (USE); Adaptive Goal Support (GOAL); and a combination of BCTs (COMBO). 79% of all EMA were completed over 12 weeks, which decreased from around 93% on week 1 to 65% by week 12. Using EMA data, relative to TRACK, only COMBO showed significant reductions in binge drinking and max drinks per drinking episode over time. Using TLFB data, there were no significant differences between groups from baseline to 14- and 28-weeks follow-up. Results lay the groundwork for a larger trial testing the effects of BCTs on binge drinking for young adults.",2019,"Text message (SMS) interventions can reduce binge drinking in young adults, but optimal behavior change techniques (BCTs) remain unknown.","['149 young adults who screened positive for hazardous drinking completed a baseline survey in the Emergency Department', 'Participants who responded to at least 50% these EMA (N\u202f=\u202f127', 'young adults']","['Cued Self-Monitoring (TRACK); Drinking Intentions Feedback (PLAN); Drinking Performance Feedback (USE', 'Text message (SMS) interventions', 'ecological momentary assessments (EMA) of drinking plans and desire to get drunk', 'BCTs (COMBO', 'SMS-delivered BCTs', 'BCTs']","['binge drinking', 'binge drinking and max drinks per drinking episode']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0001969', 'cui_str': 'Drunkenness'}]","[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",149.0,0.0524272,"Text message (SMS) interventions can reduce binge drinking in young adults, but optimal behavior change techniques (BCTs) remain unknown.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: suffbp@upmc.edu.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kirisci', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Duncan B', 'Initials': 'DB', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.01.006']
1133,30690578,Self-Managed Strength Training for Active Duty Military With a Knee Injury: A Randomized Controlled Pilot Trial.,"INTRODUCTION


Knee injuries among active duty military are one of the most frequent musculoskeletal injuries and are often caused by exercise or intense physical activity or combat training. These injuries pose a threat to force readiness. Our objective was to assess feasibility (including recruitment and retention rates) of three self-managed strengthening strategies for knee injuries and determine if they resulted in improvements in lower extremity strength, function, pain, and activity compared to usual physical therapy (PT) in military members.
METHODS


A pilot study using a randomized controlled trial was conducted at three outpatient military medical treatment facilities. After baseline testing, 78 active duty military members with a knee injury were randomized to 1-4 trial arms: (1) neuromuscular electrical stimulation (NMES) applied to the quadriceps muscle; (2) graduated strength walking using a weighted vest (WALK); (3) combined NMES with strength walking (COMBO); (4) usual PT alone. All groups received usual PT. The primary outcome was the rates of change in knee extensor and flexor strength over 18 weeks. Secondary outcomes explored the rates of change in functional performance, pain, and activities of daily living scale (ADLS). The primary analysis for the endpoints used repeated measures, linear mixed-effects models. This study was approved by Institutional Review Boards at all facilities.
RESULTS


The randomized sample (N = 78) included 19 participants in the PT-only, 20 in the WALK, 19 in the NMES and 20 in the COMBO groups. At baseline, there were no group differences. Fifty of the participants completed the 18-week study. The completers and non-completers differed at baseline on injury mechanism, with more completers injured during sports (45% vs 29%), and more non-completers during military training (36% vs 18%). Also, they differed in uninjured knee extension (completers 28% weaker), and uninjured knee flexion (completers 22% weaker). Adherence for self-reported daily step logs showed that the WALK group was 15% below goal and COMBO group 6% below goal. The 300 PV muscle stimulator showed the NMES group completed 34% of recommended stimulation sessions and the COMBO group 30%.Knee extension strength in the injured knee found only the COMBO group having a statistically higher improvement compared to PT-only (Change over 18 weeks: 10.6 kg in COMBO; 2.1 kg in PT-only). For the injured knee flexion changes, only the COMBO showed significant difference from PT-only (Change over 18 weeks: 7.5 kg in COMBO; -0.2 kg in PT-only). Similarly, for the uninjured knee, only the COMBO showed significant difference from PT-only in knee extension (Change over 18 weeks: 14.7 Kg in COMBO; 2.7 kg in PT-only) and knee flexion (Change over 18 weeks: 6.5 kg in COMBO; -0.2 kg in PT-only). Overall pain improved during the study for all groups with no significant group differences. Similarly, function and ADLS significantly improved over 18 weeks, with no significant group differences.
CONCLUSIONS


Knee extensor strength improvements in the COMBO group were significantly higher compared to usual PT. Pain, functional measures, and ADLS all improved during the study with no group differences. Further research is required to confirm these findings.",2019,"Similarly, for the uninjured knee, only the COMBO showed significant difference from PT-only in knee extension (Change over 18 weeks: 14.7 Kg in COMBO; 2.7 kg in PT-only) and knee flexion (Change over 18 weeks: 6.5 kg in COMBO; -0.2 kg in PT-only).","['three outpatient military medical treatment facilities', 'Fifty of the participants completed the 18-week study', 'Active Duty Military With a Knee Injury', '78 active duty military members with a knee injury', 'randomized sample (N = 78) included 19 participants in the PT-only, 20 in the WALK, 19 in the NMES and 20 in the COMBO groups', 'military members']","['usual physical therapy (PT', 'usual PT', 'Self-Managed Strength Training', 'neuromuscular electrical stimulation (NMES) applied to the quadriceps muscle; (2) graduated strength walking using a weighted vest (WALK); (3) combined NMES with strength walking (COMBO); (4) usual PT alone', 'NMES']","['knee flexion', 'Overall pain', 'COMBO group 30%.Knee extension strength', 'Knee extensor strength improvements', 'function and ADLS', 'uninjured knee flexion', 'Adherence for self-reported daily step logs', 'rates of change in knee extensor and flexor strength', 'lower extremity strength, function, pain, and activity', 'Pain, functional measures, and ADLS', 'rates of change in functional performance, pain, and activities of daily living scale (ADLS']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0453884', 'cui_str': 'Waistcoat'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3853978'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}]",,0.0865293,"Similarly, for the uninjured knee, only the COMBO showed significant difference from PT-only in knee extension (Change over 18 weeks: 14.7 Kg in COMBO; 2.7 kg in PT-only) and knee flexion (Change over 18 weeks: 6.5 kg in COMBO; -0.2 kg in PT-only).","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Talbot Col Usafr Ret', 'Affiliation': 'College of Medicine, University of Tennessee Health Science Center, Department of Neurology, 855 Monroe Ave, Suite 415, Memphis, TN.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brede', 'Affiliation': 'College of Medicine, University of Tennessee Health Science Center, Department of Neurology, 855 Monroe Ave, Suite 415, Memphis, TN.'}, {'ForeName': 'Marquita N', 'Initials': 'MN', 'LastName': 'Price', 'Affiliation': 'Commander, 20th Medical Operations Squadron, 20th Medical Group, Shaw AFB, SC, DSN.'}, {'ForeName': 'Pilar D', 'Initials': 'PD', 'LastName': 'Zuber', 'Affiliation': 'College of Health and Human Services, University of North Carolina at Charlotte, Department of Public Health Sciences, 9201 University City Blvd, Charlotte, NC.'}, {'ForeName': 'E Jeffrey', 'Initials': 'EJ', 'LastName': 'Metter', 'Affiliation': 'College of Medicine, University of Tennessee Health Science Center, Department of Neurology, 855 Monroe Ave, Suite 415, Memphis, TN.'}]",Military medicine,['10.1093/milmed/usy347']
1134,30718190,Effects of Chromotherapy on the Cognitive Ability of Older Adults: A Quasi-Experimental Study.,"OBJECTIVE


This study aimed to assess the effects of chromotherapy on the cognitive ability of older adults.
METHODS


This quasi-experimental pretest and posttest study was conducted among 135 older adults in Ilocos Sur, Philippines, between August and September 2015. The participants were divided into three groups: red, green, and white lights, with 45 people in each group. The cognitive ability of older adults was measured using an adapted Mini-Mental State Exam (MMSE).
RESULTS


After the interventions, the red and green light experimental groups acquired a modest increase in cognitive ability scores against the comparison white light group (p < 0.001). However, the effects were not significantly different between the red and green lights postintervention (p > 0.05).
CONCLUSION


The chromotherapy is effective in improving the cognitive ability of older adults. Specifically, the red and green lights are better than the white light in increasing the cognitive ability of older adults.",2019,"However, the effects were not significantly different between the red and green lights postintervention (p > 0.05).
","['135 older adults in Ilocos Sur, Philippines, between August and September 2015', 'Older Adults', 'older adults']","['chromotherapy', 'Chromotherapy', 'adapted Mini-Mental State Exam (MMSE']",['cognitive ability scores'],"[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085102', 'cui_str': 'Chromatotherapy'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",135.0,0.0214111,"However, the effects were not significantly different between the red and green lights postintervention (p > 0.05).
","[{'ForeName': 'Emmanuel D', 'Initials': 'ED', 'LastName': 'Paragas', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines; Nursing Services Department, JW Ruby Memorial Hospital, West Virginia University Medicine, Morgantown, WV, USA. Electronic address: emmanparagasjr@yahoo.com.'}, {'ForeName': 'Abigail Therese Y', 'Initials': 'ATY', 'LastName': 'Ng', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines. Electronic address: yapng.abigail@gmail.com.'}, {'ForeName': 'Denice Victoria L', 'Initials': 'DVL', 'LastName': 'Reyes', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines. Electronic address: denicevictoria019@gmail.com.'}, {'ForeName': 'Gerald Andrei B', 'Initials': 'GAB', 'LastName': 'Reyes', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines. Electronic address: geraldandrei.reyes@gmail.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.01.002']
1135,30221336,Is A Combination of Antibiotics and Non-Steroidal Anti-Inflammatory Drugs More Beneficial Than Antibiotic Monotherapy For The Treatment of Female Acute Uncomplicated Cystitis? A Randomized Controlled Pilot Study.,"Purpose: To compare the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) combination therapy to single-agent antibiotic therapy for the resolution of symptoms during two restricted activity days in patients with acute uncomplicated cystitis (AUC)Materials and Methods: We performed a prospective, randomized control pilot study. A total of 55 patients were enrolled. Group I (n=28) was treated with cepodoxime (100 mg twice per day), and Group II (n=27) was treated with cepodoxime (100 mg) and aceclofenac (100 mg) twice per day; both groups were treated for three days. Upon dysuria after each administration, the participants entered a value on a numerical pain scale. The primary outcome was whether there were any differences in the decrease rate in pain scale between the two groups.Result: The average age of the 55 patients was 49.9 ± 13.5 years, and prior to the clinical visit, the patients ex-perienced an average of 2.4 ± 2.2 days of dysuria symptoms. The average numerical pain scale score for dysuria was 4.98 ± 2.18. Thirty-four patients (61.8%) showed positive culture results, and E. coli was the most commonly found bacteria, cultured in 32 patients.Fifty-one patients visited the clinic on day 7, and 42 (76.4%) reported symptom improvement, while nine patients (16.3%) had persistent symptoms. The follow-up numerical pain score was 0.39 ± 1.02 points. The pain score was dramatically decreased after medication. No difference was observed in the magnitude of the pain scale reduction between the two groups (P = 0.134). However, group II showed faster symptom resolution (P = 0.035) at the third administration (day 1.5).Conclusion: Combination therapy with NSAIDs and antibiotics for AUC patients can improve symptoms faster during two restricted activity days when patients have difficulty performing daily living activities.",2018,No difference was observed in the magnitude of the pain scale reduction between the two groups (P = 0.134).,"['55 patients were enrolled', 'The average age of the 55 patients was 49.9 ± 13.5 years, and prior to the clinical visit, the patients ex-perienced an average of 2.4 ± 2.2 days of dysuria symptoms', 'Female Acute Uncomplicated Cystitis', 'patients with acute uncomplicated cystitis (AUC)Materials and Methods']","['Antibiotic Monotherapy', 'cepodoxime', 'non-steroidal anti-inflammatory drugs (NSAIDs) combination therapy', 'aceclofenac']","['numerical pain scale', 'faster symptom resolution', 'pain scale', 'pain scale reduction', 'average numerical pain scale score for dysuria', 'pain score', 'symptom improvement', 'persistent symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0050403', 'cui_str': 'aceclofenac'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",55.0,0.0570695,No difference was observed in the magnitude of the pain scale reduction between the two groups (P = 0.134).,"[{'ForeName': 'Kyungtae', 'Initials': 'K', 'LastName': 'Ko', 'Affiliation': 'Department of Urology, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea. palindromes@hanmail.net.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Cheol Young', 'Initials': 'CY', 'LastName': 'Oh', 'Affiliation': 'Department of Urology, Hallym University Hallym Sacred Heart Hospital, Gyeonggi, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.'}, {'ForeName': 'Sung Tae', 'Initials': 'ST', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Bang', 'Affiliation': 'Department of Urology, Hallym University Hallym Sacred Heart Hospital, Gyeonggi, Korea.'}, {'ForeName': 'Tae Young', 'Initials': 'TY', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Min Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Jin Seon', 'Initials': 'JS', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.'}, {'ForeName': 'Young Goo', 'Initials': 'YG', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hallym University Hallym Sacred Heart Hospital, Gyeonggi, Korea.'}, {'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.'}]",Urology journal,['10.22037/uj.v0i0.3716']
1136,30697876,The effect of short-duration resistance training on insulin sensitivity and muscle adaptations in overweight men.,"NEW FINDINGS


What is the central question of this study? What is the time course of muscular adaptations to short-duration resistance exercise training? What is the main finding and its importance? Short-duration resistance training results in early and progressive increases in muscle mass and function and an increase in insulin sensitivity.
ABSTRACT


The aim of the study was to investigate the effects of 6 weeks of resistance exercise training, composed of one set of each exercise to voluntary failure, on insulin sensitivity and the time course of adaptations in muscle strength/mass. Ten overweight men (age 36 ± 8 years; height 175 ± 9 cm; weight 89 ± 14 kg; body mass index 29 ± 3 kg m -2  ) were recruited to the study. Resistance exercise training involved three sessions per week for 6 weeks. Each session involved one set of nine exercises, performed at 80% of one-repetition maximum to volitional failure. Sessions lasted 15-20 min. Oral glucose tolerance tests were performed at baseline and post-intervention. Vastus lateralis muscle thickness, knee-extensor maximal isometric torque and rate of torque development (measured between 0 and 50, 0 and 100, 0 and 200, and 0 and 300 ms) were measured at baseline, each week of the intervention, and after the intervention. Resistance training resulted in a 16.3 ± 18.7% (P < 0.05) increase in insulin sensitivity (Cederholm index). Muscle thickness, maximal isometric torque and one-repetition maximum increased with training, and at the end of the intervention were 10.3 ± 2.5, 26.9 ± 8.3, 18.3 ± 4.5% higher (P < 0.05 for both) than baseline, respectively. The rate of torque development at 50 and 100 ms, but not at 200 and 300 ms, increased (P < 0.05) over the intervention period. Six weeks of single-set resistance exercise to failure results in improvements in insulin sensitivity and increases in muscle size and strength in young overweight men.",2019,Six weeks of single-set resistance exercise to failure results in improvements in insulin sensitivity and increases in muscle size and strength in young overweight men.,"['Ten overweight men (age 36\xa0±\xa08 years; height 175\xa0±\xa09\xa0cm; weight 89\xa0±\xa014\xa0kg; body mass index 29\xa0±\xa03\xa0kg\xa0m -2  ', 'overweight men', 'young overweight men']","['resistance exercise training', 'short-duration resistance training', 'Resistance training', 'Resistance exercise training']","['insulin sensitivity', 'Muscle thickness, maximal isometric torque and one-repetition maximum', 'insulin sensitivity (Cederholm index', 'Oral glucose tolerance tests', 'Vastus lateralis muscle thickness, knee-extensor maximal isometric torque and rate of torque development', 'rate of torque development', 'muscle size and strength', 'insulin sensitivity and muscle adaptations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0224444', 'cui_str': 'Vastus Lateralis'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]",10.0,0.0304272,Six weeks of single-set resistance exercise to failure results in improvements in insulin sensitivity and increases in muscle size and strength in young overweight men.,"[{'ForeName': 'Ahmad D', 'Initials': 'AD', 'LastName': 'Ismail', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Faris F Aba', 'Initials': 'FFA', 'LastName': 'Alkhayl', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Gray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}]",Experimental physiology,['10.1113/EP087435']
1137,30691866,"Protein timing has no effect on lean mass, strength and functional capacity gains induced by resistance exercise in postmenopausal women: A randomized clinical trial.","BACKGROUND & AIMS


Short-term studies have shown that protein intake immediately post-exercise increases muscle protein synthesis. However, the effect of protein timing (comparing protein intake post-exercise vs. several hours after exercise) on lean mass and strength gains in long-term studies is still not fully elucidated. Thus, the aim of our study was to evaluate the effect of protein timing on lean mass, strength and functional capacity gains induced by resistance exercise in postmenopausal women.
METHODS


Thirty-four postmenopausal women (60.9 ± 6.7 years) participated in this double-blind, parallel-group, randomized clinical trial. All individuals performed the same resistance training protocol in the morning, 3 times a week, at 70% of 1-maximum repetition (1-RM), over 8 weeks. Participants were randomly assigned to protein-carbohydrate group (PC) (n = 17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n = 17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Lean mass was assessed using dual-energy X-ray absorptiometry, handgrip strength by a dynamometer, and strength was evaluated by 1-RM of bench press and leg extension. One mile walk test was performed to assess the functional capacity.
RESULTS


Both the PC group (37.3 [35.0-39.7] to 38.1 [35.9-40.5] kg) and the CP group (38.2 [36.0-40.5] to 38.8 [36.5-41.3] kg) increased the total lean mass (p < 0.001). An increase was also observed in both groups for 1-RM bench press, 1-RM leg extension and handgrip strength (p < 0.001). In addition, the time of 1-mile walk test decreased in both groups (p = 0.019). No differences were noted for group and time interaction for these variables (p > 0.05).
CONCLUSION


Protein timing has no effect on lean mass, strength and functional capacity gains induced by resistance exercise in postmenopausal women. This trial was registered at ClinicalTrials.gov as NCT03372876.",2020,"In addition, the time of 1-mile walk test decreased in both groups (p = 0.019).","['postmenopausal women', 'Thirty-four postmenopausal women (60.9\xa0±\xa06.7 years']","['protein-carbohydrate group (PC) (n\xa0=\xa017), that ingested 30\xa0g of whey protein immediately after exercise and 30\xa0g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n\xa0=\xa017), that ingested 30\xa0g of maltodextrin immediately after exercise and 30\xa0g of whey protein in the afternoon']","['Lean mass', 'time of 1-mile walk test', '1-RM bench press, 1-RM leg extension and handgrip strength', 'lean mass, strength and functional capacity gains', 'total lean mass', 'lean mass and strength gains']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",34.0,0.203918,"In addition, the time of 1-mile walk test decreased in both groups (p = 0.019).","[{'ForeName': 'Flávia M S', 'Initials': 'FMS', 'LastName': 'de Branco', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Marcelo A S', 'Initials': 'MAS', 'LastName': 'Carneiro', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, MG, Brazil; Department of Sport Sciences, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Luana T', 'Initials': 'LT', 'LastName': 'Rossato', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Paula C', 'Initials': 'PC', 'LastName': 'Nahas', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Kely R C', 'Initials': 'KRC', 'LastName': 'Teixeira', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Gersiel N', 'Initials': 'GN', 'LastName': 'de Oliveira', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, MG, Brazil; Department of Sport Sciences, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Fábio L', 'Initials': 'FL', 'LastName': 'Orsatti', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, MG, Brazil; Department of Sport Sciences, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Erick P', 'Initials': 'EP', 'LastName': 'de Oliveira', 'Affiliation': 'School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, Minas Gerais, Brazil. Electronic address: erick_po@yahoo.com.br.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.01.008']
1138,28750548,"A feasibility study of a novel, task-specific movement training intervention for women with patellofemoral pain.","OBJECTIVE


To investigate whether a novel, task-specific training intervention that focused on correcting pain-producing movement patterns was feasible and whether it would improve hip and knee kinematics, pain, and function in women with patellofemoral pain.
DESIGN


Prospective, non-randomized, within-group, double baseline, feasibility intervention study.
SUBJECTS


A total of 25 women with patellofemoral pain were enrolled.
INTERVENTION


The intervention, delivered 2×/week for six weeks, consisted of supervised, high-repetition practice of daily weight-bearing and recreational activities. Activities were selected and progressed based on participants' interest and ability to maintain optimal alignment without increasing pain.
MAIN MEASURES


Primary feasibility outcomes were recruitment, retention, adherence, and treatment credibility (Credibility/Expectancy Questionnaire). Secondary outcomes assessing intervention effects were hip and knee kinematics, pain (visual analog scale: current, average in past week, maximum in past week), and function (Patient-Specific Functional Scale).
RESULTS


A total of 25 participants were recruited and 23 were retained (92% retention). Self-reported average daily adherence was 79% and participants were able to perform their prescribed home program correctly (reduced hip and knee frontal plane angles) by the second intervention visit. On average, treatment credibility was rated 25 (out of 27) and expectancy was rated 22 (out of 27). Hip and knee kinematics, pain, and function improved following the intervention when compared to the control phase.
CONCLUSION


Based on the feasibility outcomes and preliminary intervention effects, this task-specific training intervention warrants further investigation and should be evaluated in a larger, randomized clinical trial.",2018,"Hip and knee kinematics, pain, and function improved following the intervention when compared to the control phase.
","['25 women with patellofemoral pain were enrolled', 'women with patellofemoral pain', 'A total of 25 participants were recruited and 23 were retained (92% retention']","['novel, task-specific training intervention', 'novel, task-specific movement training intervention', 'task-specific training intervention']","['Hip and knee kinematics, pain, and function', 'recruitment, retention, adherence, and treatment credibility (Credibility/Expectancy Questionnaire', 'Self-reported average daily adherence', 'hip and knee kinematics, pain, and function', 'hip and knee kinematics, pain (visual analog scale: current, average in past week, maximum in past week), and function (Patient-Specific Functional Scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}]",25.0,0.0592801,"Hip and knee kinematics, pain, and function improved following the intervention when compared to the control phase.
","[{'ForeName': 'Gretchen B', 'Initials': 'GB', 'LastName': 'Salsich', 'Affiliation': '1 Program in Physical Therapy, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Yemm', 'Affiliation': '1 Program in Physical Therapy, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steger-May', 'Affiliation': '2 Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lang', 'Affiliation': '3 Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Van Dillen', 'Affiliation': '3 Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, USA.'}]",Clinical rehabilitation,['10.1177/0269215517723055']
1139,30081380,Cognitive function of patients with treatment-resistant depression after a single low dose of ketamine infusion.,"BACKGROUND


Clinical and animal studies have reported conflicting results regarding the effect of ketamine on cognitive function, although increasing evidence supports a rapid and sustained antidepressant effect of a subanesthetic dose of ketamine infusion for patients with treatment-resistant depression (TRD). However, the cognitive function before and after ketamine infusion was rarely investigated in patients with TRD.
METHODS


A total of 71 adult patients with TRD were enrolled and randomized to 0.5-mg/kg ketamine, 0.2-mg/kg ketamine, or normal saline infusion groups. Depressive symptoms were measured using the Hamilton Depression Rating Scale at baseline and at different time points post ketamine infusion. Cognitive function was evaluated using working memory and go/no-go tasks at baseline, Day 3, and Day 14 post ketamine infusion.
RESULTS


A single low dose of ketamine infusion did not impair the cognitive function of patients with TRD. The paired t test revealed that patients with TRD receiving 0.5 mg/kg of ketamine infusion exhibited a slight improvement in sustained attention and response control measured using the go/no-go task at Day 14 post ketamine infusion. A significant association was also observed between depressive symptoms and cognitive function changes at Day 3 in the 0.5-mg/kg ketamine infusion group.
DISCUSSION


A 0.5 mg/kg dose of ketamine infusion was not harmful, but slightly beneficial, for the cognitive function of patients with TRD. Additional studies are necessary to elucidate the effects of repeated ketamine infusion on cognitive function.",2018,"A 0.5 mg/kg dose of ketamine infusion was not harmful, but slightly beneficial, for the cognitive function of patients with TRD.","['patients with TRD', 'patients with treatment-resistant depression after a single low dose of', 'patients with treatment-resistant depression (TRD', '71 adult patients with TRD']","['ketamine', 'ketamine, 0.2-mg/kg ketamine, or normal saline infusion groups', 'ketamine infusion']","['cognitive function', 'depressive symptoms and cognitive function changes', 'Depressive symptoms', 'Cognitive function', 'Hamilton Depression Rating Scale', 'sustained attention and response control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",71.0,0.0395257,"A 0.5 mg/kg dose of ketamine infusion was not harmful, but slightly beneficial, for the cognitive function of patients with TRD.","[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan. Electronic address: on5083@msn.com.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: tomsu0402@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2018.07.033']
1140,30690645,Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial.,"Background


Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences.
Objective


To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control.
Design


Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061).
Setting


13 medical and surgical ICUs at 5 hospitals.
Participants


Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses.
Intervention


A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting.
Measurements


The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation.
Results


The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ.
Limitation


Contamination among clinicians could have biased results toward the null hypothesis.
Conclusion


A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making.
Primary Funding Source


National Institutes of Health.",2019,"A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes.","['277 patients, 416 surrogates, and 427 clinicians', 'Patients With Prolonged Mechanical Ventilation', 'Participants\n\n\nAdult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses']","['decision aid about prolonged mechanical ventilation', 'information according to usual care practices followed by a family meeting', 'Personalized Web-Based Decision Aid']","['decisional conflict', 'psychological distress', 'Concordance improvement', 'physician estimates', 'clinician-surrogate concordance scale', '1-year survival estimates', 'experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",277.0,0.149238,"A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Duke University, Durham, North Carolina (C.E.C., D.M.J.).'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (D.B.W., J.M.K.).'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'University of Washington, Seattle, Washington (C.L.H.).'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Jones', 'Affiliation': 'Duke University, Durham, North Carolina (C.E.C., D.M.J.).'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Kahn', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (D.B.W., J.M.K.).'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Duke University and the Center for Health Services Research in Primary Care at the Durham VA Medical Center, Durham, North Carolina (M.K.O.).'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado, Aurora, Colorado (C.L.L.).'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina (L.C.H., S.S.C.).'}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Carson', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina (L.C.H., S.S.C.).'}]",Annals of internal medicine,['10.7326/M18-2335']
1141,31690089,Moderators of the effect of guided online self-help for people with HIV and depressive symptoms.,"The goal of the study was to investigate moderators of intervention effect of a guided Internet-based self-help cognitive behavioral intervention for people with HIV and depressive symptoms. This study was part of a randomized controlled trial where the intervention was found to be effective in reducing depressive symptoms, compared to an attention-only control group. Demographic characteristics (e.g., age), HIV characteristics (e.g., duration of HIV), and psychological characteristics (e.g., coping self-efficacy) were investigated as potential moderators of intervention effect. In 2015, 188 people with HIV and depressive symptoms were included in the study: 97 were randomized to the intervention group and 91 to the control group. Two moderators of intervention effect were found: coping self-efficacy and baseline depression severity. Participants with low coping self-efficacy and baseline depression severity improved more in the intervention group than in the control group, and participants with high coping self-efficacy and baseline depression severity improved in both groups. The results indicate that the intervention may be provided to all people with HIV and depressive symptoms. It may be especially important for people with HIV and low coping self-efficacy to start with the intervention since they show less improvement in the control group with only attention.  Trial registration:  Nederlands Trialregister NTR5407, September 11, 2015.",2020,"Participants with low coping self-efficacy and baseline depression severity improved more in the intervention group than in the control group, and participants with high coping self-efficacy and baseline depression severity improved in both groups.","['188 people with HIV and depressive symptoms were included in the study: 97', 'people with HIV and depressive symptoms']","['guided Internet-based self-help cognitive behavioral intervention', 'guided online self-help']","['low coping self-efficacy and baseline depression severity', 'depressive symptoms', 'Demographic characteristics (e.g., age), HIV characteristics (e.g., duration of HIV), and psychological characteristics (e.g., coping self-efficacy', 'high coping self-efficacy and baseline depression severity', 'coping self-efficacy and baseline depression severity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",97.0,0.0692081,"Participants with low coping self-efficacy and baseline depression severity improved more in the intervention group than in the control group, and participants with high coping self-efficacy and baseline depression severity improved in both groups.","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'van Luenen', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Kraaij', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dusseldorp', 'Affiliation': 'Institute of Psychology, Section of Methodology and Statistics, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Garnefski', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}]",AIDS care,['10.1080/09540121.2019.1679703']
1142,30710323,Pretreatment metabolic tumour volume in stage IIIA/B non-small-cell lung cancer uncovers differences in effectiveness of definitive radiochemotherapy schedules: analysis of the ESPATUE randomized phase 3 trial.,"PURPOSE


According to the ACRIN 6668/RTOG 0235 trial, pretreatment metabolic tumour volume (MTV) as detected by  18 F-fluorodeoxyglucose PET/CT is a prognostic factor in patients with stage III non-small-cell lung cancer (NSCLC) after definitive radiochemotherapy (RCT). To validate the prognostic value of MTV in patients with stage III NSCLC after RCT, we analysed mature survival data from the German phase III trial ESPATUE.
METHODS


This analysis included patients who were staged by PET/CT and who were enrolled in the ESPATUE trial, a randomized study comparing definitive RCT (arm A) with surgery (arm B) after induction chemotherapy and RCT in patients with resectable stage IIIA/IIIB NSCLC. Patients refusing surgery and those with nonresectable disease were scheduled to receive definitive RCT. MTV was measured using a fixed threshold-based approach and a model-based iterative volume thresholding approach. Data were analysed using proportional hazards models and Kaplan-Meier survival functions.
RESULTS


MTV as a continuous variable did not reveal differences in survival between the 117 patients scheduled to receive definitive RCT and all 169 enrolled patients who underwent pretreatment PET/CT (p > 0.5). Five-year survival rates were 33% (95% CI 17-49%) in patients scheduled for definitive RCT with a high MTV (>95.4 ml) and 32% (95% CI: 22-42%) in those with a low MTV. The hazard ratio for survival was 0.997 (95% CI 0.973-1.022) per 10-ml increase in MTV and the slope was significantly shallower than that in the ACRIN 6668/RTOG 0235 trial (random effects model, p = 0.002). There were no differences in MTV size distributions between the ACRIN and ESPATUE trials (p = 0.97).
CONCLUSION


Patients with stage III NSCLC and a large MTV in whom definitive RCT had a particularly good survival in the ESPATUE trial. Treatment individualization according to MTV is not supported by this study. The ESPATUE and ACRIN trials differed by the use of cisplatin-containing induction chemotherapy and an intensified radiotherapy regimen that were particularly effective in patients with large MTV disease.",2019,Five-year survival rates were 33% (95% CI 17-49%) in patients scheduled for definitive RCT with a high MTV (>95.4 ml) and 32% (95% CI: 22-42%) in those with a low MTV.,"['patients with large MTV disease', '117 patients scheduled to receive definitive RCT and all 169 enrolled patients who underwent', 'patients who were staged by PET/CT and who were enrolled', 'patients with stage III NSCLC after RCT, we analysed mature survival data from the German phase III trial ESPATUE', 'patients with stage III non-small-cell lung cancer (NSCLC) after definitive radiochemotherapy (RCT', 'patients with resectable stage IIIA/IIIB NSCLC', 'Patients refusing surgery and those with nonresectable disease']","['pretreatment PET/CT', 'induction chemotherapy and RCT', 'cisplatin-containing induction chemotherapy', 'definitive RCT', 'MTV']","['survival', 'MTV size distributions', 'hazard ratio for survival', 'Five-year survival rates', 'good survival', 'MTV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",169.0,0.343627,Five-year survival rates were 33% (95% CI 17-49%) in patients scheduled for definitive RCT with a high MTV (>95.4 ml) and 32% (95% CI: 22-42%) in those with a low MTV.,"[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Guberina', 'Affiliation': 'Department of Radiation Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, Hufelandstr. 55, 45122, Essen, Germany.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Eberhardt', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, 45122, Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stuschke', 'Affiliation': 'Department of Radiation Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, Hufelandstr. 55, 45122, Essen, Germany. martin.stuschke@uk-essen.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gauler', 'Affiliation': 'Department of Radiation Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, Hufelandstr. 55, 45122, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'German Cancer Consortium (DKTK), Partner Site University Hospital Essen, 45122, Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, 45122, Essen, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Stamatis', 'Affiliation': 'Department of Thoracic Surgery, Ruhrlandklinik, University of Duisburg-Essen Medical School, 45239, Essen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Theegarten', 'Affiliation': 'Department of Pathology, West German Cancer Center, University of Duisburg-Essen Medical School, 45122, Essen, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Jentzen', 'Affiliation': 'Department of Nuclear Medicine, West German Cancer Center, University of Duisburg-Essen Medical School, 45122, Essen, Germany.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Herrmann', 'Affiliation': 'German Cancer Consortium (DKTK), Partner Site University Hospital Essen, 45122, Essen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Pöttgen', 'Affiliation': 'Department of Radiation Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, Hufelandstr. 55, 45122, Essen, Germany.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-019-4270-x']
1143,31633603,The role of goal-directed therapy in the prevention of acute kidney injury after major gastrointestinal surgery: Substudy of the OPTIMISE trial.,"BACKGROUND


Acute kidney injury (AKI) is an important adverse outcome after major surgery. Peri-operative goal-directed haemodynamic therapy (GDT) may improve outcomes by reducing complications such as AKI.
OBJECTIVE


To determine if GDT was associated with a reduced incidence of postoperative AKI according to specific renal biomarkers.
DESIGN


Prospective substudy of the OPTIMISE trial, a multicentre randomised controlled trial comparing peri-operative GDT to usual patient care.
SETTING


Four UK National Health Service hospitals.
PATIENTS


A total of 287 high-risk patients aged at least 50 years undergoing major gastrointestinal surgery.
OUTCOME MEASURES


The primary outcome measure was AKI defined as urinary neutrophil gelatinase-associated lipase (NGAL) at least 150 ng ml 24 and 72 h after surgery. Secondary outcomes were between-group differences in NGAL measurements and NGAL : creatinine ratios 24 and 72 h after surgery and AKI stage 2 or greater according to Kidney Disease Improving Global Outcomes (KDIGO) criteria within 30 days of surgery.
RESULTS


In total, 20 of 287 patients (7%) experienced postoperative AKI of KDIGO grade 2 or 3 within 30 days. The proportion of patients with urinary NGAL at least 150 ng ml 24 or 72 h after surgery was similar in the two groups [GDT 31/144 (21.5%) patients vs. usual patient care 28/143 (19.6%) patients; P = 0.88]. Absolute values of urinary NGAL were also similar at 24 h (GDT 53.5 vs. usual patient care 44.1 ng ml; P = 0.38) and 72 h (GDT 45.1 vs. usual patient care 41.1 ng ml; P = 0.50) as were urinary NGAL : creatinine ratios at 24 h (GDT 45 vs. usual patient care 43 ng mg; P = 0.63) and 72 h (GDT 66 vs. usual patient care 63 ng mg; P = 0.62). The incidence of KDIGO-defined AKI was also similar between the groups [GDT 9/144 (6%) patients vs. usual patient care 11/143 (8%) patients; P = 0.80].
CONCLUSION


In this trial, GDT did not reduce the incidence of AKI amongst high-risk patients undergoing major gastrointestinal surgery. This may reflect improving standards in usual patient care.
TRIAL REGISTRATION


OPTIMISE Trial Registration ISRCTN04386758.",2019,"In this trial, GDT did not reduce the incidence of AKI amongst high-risk patients undergoing major gastrointestinal surgery.","['risk patients undergoing major gastrointestinal surgery', '287 high-risk patients aged at least 50 years undergoing major gastrointestinal surgery', 'acute kidney injury after major gastrointestinal surgery', 'Four UK National Health Service hospitals']","['Peri-operative goal-directed haemodynamic therapy (GDT', 'GDT', 'peri-operative GDT']","['postoperative AKI', 'NGAL measurements and NGAL\u200a:\u200acreatinine ratios 24 and 72\u200ah after surgery and AKI stage 2 or greater according to Kidney Disease Improving Global Outcomes (KDIGO) criteria', 'incidence of KDIGO-defined AKI', 'proportion of patients with urinary NGAL', 'Absolute values of urinary NGAL', 'AKI defined as urinary neutrophil gelatinase-associated lipase (NGAL']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",287.0,0.516856,"In this trial, GDT did not reduce the incidence of AKI amongst high-risk patients undergoing major gastrointestinal surgery.","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'MacDonald', 'Affiliation': 'From the Department of Peri-operative Medicine and Pain, Royal London Hospital, London, UK (NM), UCD School of Medicine (PTM, PD), Clinical Research Centre, UCD School of Medicine, University College Dublin, Dublin, Ireland (RI) and William Harvey Research Institute, Queen Mary University of London, Charterhouse Square, London, UK (RMP, JRP).'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Pearse', 'Affiliation': ''}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Murray', 'Affiliation': ''}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Inzitari', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Prowle', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001104']
1144,31644512,Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial.,"BACKGROUND


The Spritztube is a new supraglottic airway device combining the ability to allow extraglottic ventilation of the lungs with the opportunity to perform fibreoptic-assisted intubation.
OBJECTIVES


To compare the Spritztube tracheal cannula with the Laryngeal Mask Airway Supreme (LMA-S) in anaesthetised adult patients.
DESIGN


A single-centre, randomised controlled study.
SETTING


Tertiary hospital.
PATIENTS


Mechanically ventilated patients undergoing elective surgery in the supine position under general anaesthesia were included. Main exclusion criteria were a history of, or predicted, difficult airway management according to SIAARTI guidelines and absence of written informed consent.
INTERVENTIONS


Patients received the LMA-S or Spritztube tracheal cannula to facilitate ventilation of the lungs.
MAIN OUTCOME MEASURES


Successful placement (primary outcome), time required for insertion, number of attempts, subjective assessment of ease of insertion, safety and incidence of complications were recorded.
RESULTS


One hundred and sixty seven patients were allocated to the LMA-S or Spritztube group, respectively, a total of 334 patients. In the LMA-S group, the device insertion failed in nine patients, compared with none in the Spritztube group (P = 0.002). Spritztube insertion was easy in 100% of cases compared with 94.6% of the cases in the LMA-S group (P = 0.03). The number of attempts was significantly higher with the LMA-S compared with the Spritztube (P = 0.0007), whereas the insertion times were comparable (P = 0.06). Except for the incidence of blood-staining, which was higher in the LMA-S group (P = 0.01), the number of complications was comparable in the two groups.
CONCLUSION


The Spritztube was as effective as the LMA-S in maintaining the airway with all patients being successfully ventilated without difficulty. The success rate of achieving a patent airway was comparable between the groups, with a similar occurrence of complications.
TRIAL REGISTRATION


NCT03443219.",2019,The Spritztube was as effective as the LMA-S in maintaining the airway with all patients being successfully ventilated without difficulty.,"['Tertiary hospital', 'Mechanically ventilated patients undergoing elective surgery in the supine position under general anaesthesia were included', 'anaesthetised adult patients', 'One hundred and sixty seven patients']","['LMA-S or Spritztube', 'Laryngeal Mask Airway Supreme™ vs. the Spritztube® tracheal cannula', 'LMA-S or Spritztube tracheal cannula to facilitate ventilation of the lungs', 'Spritztube tracheal cannula with the Laryngeal Mask Airway Supreme (LMA-S']","['incidence of blood-staining', 'time required for insertion, number of attempts, subjective assessment of ease of insertion, safety and incidence of complications', 'success rate of achieving a patent airway', 'number of complications', 'number of attempts']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005768'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]",334.0,0.107823,The Spritztube was as effective as the LMA-S in maintaining the airway with all patients being successfully ventilated without difficulty.,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Rosa', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care, San Bortolo Hospital, Vicenza (SDR, AR, AP, EB, PG, VU, AP, RB, SCC), Department of Anaesthesia and Intensive Care Medicine, Maggiore Della Carità University Hospital, Novara (AM, DC) and Anesthesia and Intensive Care, AOU Policlinico Vittorio Emanuele, Catania, Italy (MS).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Messina', 'Affiliation': ''}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Sorbello', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rigobello', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Colombo', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piccolo', 'Affiliation': ''}, {'ForeName': 'Efrem', 'Initials': 'E', 'LastName': 'Bonaldi', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gennaro', 'Affiliation': ''}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Urukalo', 'Affiliation': ''}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Pellizzari', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Bonato', 'Affiliation': ''}, {'ForeName': 'Stefano Checcacci', 'Initials': 'SC', 'LastName': 'Carboni', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001106']
1145,31688930,Five-Day Changes in Biomarkers of Exposure Among Adult Smokers After Completely Switching From Combustible Cigarettes to a Nicotine-Salt Pod System.,"INTRODUCTION


This study examined changes in biomarkers of exposure (BoE) after 5 days of nicotine-salt pod system (NSPS) use, compared with continuation of usual-cigarette smoking and cigarette abstinence, among adult combustible cigarette smokers.
AIMS AND METHODS


A randomized, open-label, parallel-cohort, confinement study of healthy adult smokers, naive to NSPS use, was conducted. Participants (N = 90) were randomized to six cohorts (n = 15 each): exclusive ad libitum use of NSPS (four flavors: Virginia Tobacco, Mint, Mango, Creme), continuation of usual-brand cigarette smoking, or cigarette abstinence. Total nicotine equivalents and BoE (NNN, NNAL, 3-HPMA, MHBMA, S-PMA, HMPMA, CEMA, 1-OHP, and COHb) were measured.
RESULTS


Eight non-nicotine BoEs, measured in urine, were reduced by an aggregate of 85.0% in the pooled NSPS cohort; increased by 14.4% in the cigarette cohort (p < .001 for pooled NSPS vs. cigarette); and reduced by 85.3% in the abstinence cohort (p > .05; 99.6% relative reduction between pooled NSPS vs. abstinence). Similar changes in individual BoEs were also observed (p < .001 for each BoE between pooled NSPS vs. cigarettes; and abstinence vs. pooled NSPS; p > .05 for each BoE between pooled NSPS vs. abstinence). Blood COHb decreased by 71.8% in the pooled NSPS cohort and 69.1% in the abstinence cohort (p > .05) and increased by 13.3% in the cigarette cohort (p < .001). Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (p > .05).
CONCLUSION


Complete switching from cigarettes to NSPS produced significant reductions in key non-nicotine BoEs associated with cigarette smoking.
IMPLICATIONS


The results of this study concorded with evidence that complete switching from combustible cigarettes to tobacco and nontobacco-flavored vapor products may reduce exposure to key carcinogens and other toxicants known to be associated with tobacco-related diseases. Future research is needed to assess the long-term health effects of NSPS use. These results should not be interpreted to mean that the use of NSPS is without any risk, particularly for nonusers of tobacco products.",2020,"Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (P>0.05).
","['healthy adult smokers, naive to NSPS use was conducted', 'Adult Smokers after Completely Switching from Combustible Cigarettes to a Nicotine-Salt Pod System', 'Participants (N=90) were randomized to 6 cohorts (n=15 each', 'adult combustible cigarette smokers']","['nicotine-salt pod system (NSPS', 'exclusive ad libitum use of NSPS (4 flavors: Virginia Tobacco, Mint, Mango, Creme), continuation of usual brand cigarette smoking, or cigarette abstinence']","['Blood COHb', 'Mean total urine nicotine equivalents', 'individual BoEs', 'Total nicotine equivalents and biomarkers of exposure (NNN, NNAL, 3-HPMA, MHBMA, S-PMA, HMPMA, CEMA, 1-OHP, and COHb']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0452249', 'cui_str': 'Mint - sweet'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0005768'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0063186', 'cui_str': 'hydroxypropyl methacrylate'}, {'cui': 'C0048451', 'cui_str': 'p-methoxy-alpha-methylphenethylamine'}]",,0.0160007,"Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (P>0.05).
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jay', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Pfaunmiller', 'Affiliation': 'Celerion, Inc., Lincoln, NE.'}, {'ForeName': 'Norman J', 'Initials': 'NJ', 'LastName': 'Huang', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Cohen', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Graff', 'Affiliation': 'JUUL Labs, Inc., San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz206']
1146,31666344,"Prolonged survival in the absence of disease-recurrence in advanced-stage follicular lymphoma following chemo-immunotherapy: 13-year update of the prospective, multicenter randomized GITMO-IIL trial.","A prospective trial conducted in the period 2000-2005 showed no survival advantage for high-dose chemotherapy with rituximab and autograft (R-HDS)  versus  conventional chemotherapy with rituximab (CHOP-R) as first-line therapy in 134 high-risk follicular lymphoma patients aged <60 years. The study has been updated at the 13-year median follow up. As of February 2017, 88 (66%) patients were alive, with overall survival of 66.4% at 13 years, without a significant difference between R-HDS (64.5%) and CHOP-R (68.5%). To date, 46 patients have died, mainly because of disease progression (47.8% of all deaths), secondary malignancies (3 solid tumor, 9 myelodysplasia/acute leukemia; 26.1% of all deaths), and other toxicities (21.7% of all deaths). Complete remission was documented in 98 (73.1%) patients and associated with overall survival, with 13-year estimates of 77.0% and 36.8% for complete remission  versus  no-complete remission, respectively. Molecular remission was documented in 39 (65%) out of 60 evaluable patients and associated with improved survival. In multivariate analysis, complete remission achievement had the strongest effect on survival ( P <0.001), along with younger age ( P =0.002) and female sex ( P =0.013). Overall, 50 patients (37.3%) survived with no disease recurrence (18 CHOP-R, 32 R-HDS). This follow up is the longest reported on follicular lymphoma treated upfront with rituximab-chemotherapy and demonstrates an unprecedented improvement in survival compared to the pre-rituximab era, regardless of the use of intensified or conventional treatment. Complete remission was the most important factor for prolonged survival and a high proportion of patients had prolonged survival in their first remission, raising the issue of curability in follicular lymphoma. (Registered at clinicaltrials.gov identifier: 00435955).",2019,"Complete remission was the most important factor for prolonged survival and a high proportion of patients had prolonged survival in their first remission, raising the issue of curability in follicular lymphoma.","['134 high-risk follicular lymphoma patients aged <60 years', '46 patients have died, mainly because of disease progression (47.8% of all deaths), secondary malignancies (3 solid tumor, 9 myelodysplasia/acute leukemia; 26.1% of all deaths), and other toxicities (21.7% of all deaths']","['rituximab-chemotherapy', 'chemotherapy with rituximab and autograft (R-HDS)  versus  conventional chemotherapy with rituximab (CHOP-R']","['Complete remission', 'survival', 'prolonged survival', 'Prolonged survival', 'Molecular remission', 'survival advantage', 'overall survival', 'disease recurrence']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}]",134.0,0.244075,"Complete remission was the most important factor for prolonged survival and a high proportion of patients had prolonged survival in their first remission, raising the issue of curability in follicular lymphoma.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bruna', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Hematology University Division, Verona.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Boccomini', 'Affiliation': 'Hematology Division, Città della Salute Hospital, Torino.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Patti', 'Affiliation': 'Hematology Division, Azienda Villa Sofia-Cervello, Palermo.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Barbui', 'Affiliation': 'Hematology Division, Papa Giovanni XXIII Hospital, Bergamo.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pulsoni', 'Affiliation': 'Department of Cellular Biotechnologies and Hematology, La Sapienza University, Roma.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Musso', 'Affiliation': 'Hematology Unit, La Maddalena Hospital, Palermo.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'SC Oncoematologia, Università degli Studi di Perugia.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gini', 'Affiliation': 'Hematology University Division, Ancona.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Castellino', 'Affiliation': 'Department of Hematology, S. Croce e Carle Hospital, Cuneo.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Rossini', 'Affiliation': 'Hematology University Division, Monza.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ciceri', 'Affiliation': 'Hematology Unit HSR, Milano.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Rota-Scalabrini', 'Affiliation': 'Oncologia Medica, Cancer Institute FPO, IRCCS, Candiolo.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Stelitano', 'Affiliation': 'Hematology Division, Reggio Calabria.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Raimondo', 'Affiliation': 'Hematology Univiversity Division, Catania.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'Division of Hematology, Brescia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Devizzi', 'Affiliation': 'University Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Zoli', 'Affiliation': 'Hematology Division, S. Camillo Hospital, Roma.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zallio', 'Affiliation': 'SC Ematologia AO SS Antonio e Biagio e Cesare Arrigo, Alessandria.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Narni', 'Affiliation': 'Hematology University Division, Modena.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dondi', 'Affiliation': 'Division of Oncology, Modena.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Parvis', 'Affiliation': 'Division of Internal Medicine, S. Luigi Hospital, Orbassano.'}, {'ForeName': 'Gianpietro', 'Initials': 'G', 'LastName': 'Semenzato', 'Affiliation': 'Hematology University Division, Padova.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lanza', 'Affiliation': 'Hematology Unit, Cremona.'}, {'ForeName': 'Tommasina', 'Initials': 'T', 'LastName': 'Perrone', 'Affiliation': 'Hematology University Division, Bari.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Angrilli', 'Affiliation': 'Hematology Division, Pescara.'}, {'ForeName': 'Atto', 'Initials': 'A', 'LastName': 'Billio', 'Affiliation': 'Hematology Division, Bolzano.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gueli', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mantoan', 'Affiliation': 'Hematology University Division, Città della Salute Hospital, Torino.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Hematology Division, Papa Giovanni XXIII Hospital, Bergamo.'}, {'ForeName': 'Alessandro Massimo', 'Initials': 'AM', 'LastName': 'Gianni', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'University Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Passera', 'Affiliation': 'Nuclear Medicine Division, Città della Salute Hospital, Torino.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ladetto', 'Affiliation': 'SC Ematologia AO SS Antonio e Biagio e Cesare Arrigo, Alessandria.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano corrado.tarella@unimi.it.'}]",Haematologica,['10.3324/haematol.2018.209932']
1147,31302205,A randomized trial provided new evidence on the accuracy and efficiency of traditional vs. electronically annotated abstraction approaches in systematic reviews.,"OBJECTIVES


Data Abstraction Assistant (DAA) is a software for linking items abstracted into a data collection form for a systematic review to their locations in a study report. We conducted a randomized cross-over trial that compared DAA-facilitated single-data abstraction plus verification (""DAA verification""), single data abstraction plus verification (""regular verification""), and independent dual data abstraction plus adjudication (""independent abstraction"").
STUDY DESIGN AND SETTING


This study is an online randomized cross-over trial with 26 pairs of data abstractors. Each pair abstracted data from six articles, two per approach. Outcomes were the proportion of errors and time taken.
RESULTS


Overall proportion of errors was 17% for DAA verification, 16% for regular verification, and 15% for independent abstraction. DAA verification was associated with higher odds of errors when compared with regular verification (adjusted odds ratio [OR] = 1.08; 95% confidence interval [CI]: 0.99-1.17) or independent abstraction (adjusted OR = 1.12; 95% CI: 1.03-1.22). For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
CONCLUSION


Independent abstraction may only be necessary for complex data items. DAA provides an audit trail that is crucial for reproducible research.",2019,"For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
",['26 pairs of data abstractors'],"['DAA-facilitated single-data abstraction plus verification (""DAA verification']",['proportion of errors and time taken'],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",,0.133149,"For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
","[{'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E6140, Baltimore, MD 21205, USA. Electronic address: tli19@jhu.edu.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Saldanha', 'Affiliation': 'Center for Evidence Synthesis in Health, Department of Health Services, Policy, and Practice, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA; Department of Epidemiology (Secondary), Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jap', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Bryant T', 'Initials': 'BT', 'LastName': 'Smith', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Canner', 'Affiliation': 'Department of Surgery, Center for Outcomes Research, Johns Hopkins School of Medicine, 720 Rutland Avenue, Turner 74, Baltimore, MD 21205, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Hutfless', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, 600 N Wolfe St, Blalock 406, Baltimore, MD 21205, USA.'}, {'ForeName': 'Vernal', 'Initials': 'V', 'LastName': 'Branch', 'Affiliation': '119 Landings Drive, Suite 403, Mooresville, NC 28117, USA.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Carini', 'Affiliation': 'Department of Medicine, School of Medicine, University of California San Francisco, 3333 California Street, San Francisco, CA 94143, USA.'}, {'ForeName': 'Wiley', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Internal Medicine, Kaiser Permanente Northwest, 500 NE Multnomah Street, Suite 100, KPB-2, Portland, OR 97232, USA.'}, {'ForeName': 'Berry', 'Initials': 'B', 'LastName': 'de Bruijn', 'Affiliation': 'Internal Medicine, National Research Council Canada, Digital Technologies Research Centre, 1200 Montreal Road, Ottawa, Ontario K1A 0R6, Canada.'}, {'ForeName': 'Byron C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Internal Medicine, College of Computer and Information Science, Northeastern University, 440 Huntington Avenue, 476 West Village H, Boston, MA 02115, USA.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Walsh', 'Affiliation': 'Internal Medicine, California Breast Cancer Organizations, 900 Kent Drive, Davis, CA 95616, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Whamond', 'Affiliation': 'Internal Medicine, Cochrane Consumer Network, 1421 Woodstock Road, Fredericton, New Brunswick E3C 1P2, Canada.'}, {'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Murad', 'Affiliation': 'Internal Medicine, Evidence-based Practice Center, Mayo Clinic, 200 1st Street, Rochester, MN 55905, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Sim', 'Affiliation': 'Department of Medicine, University of California San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Berlin', 'Affiliation': 'Internal Medicine, Epidemiology, Johnson & Johnson, 1125 Trenton-Harbourton Road, K3-Zone 1, Titusville, NJ 08560, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lau', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Dickersin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E6152, Baltimore, MD 21205, USA.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Schmid', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, 121 South Main Street, Box G-S121-7, Providence, RI 02912, USA.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.07.005']
1148,30685963,A prospective randomized clinical study evaluating the efficacy and compliance of oral sulfate solution and 2-L ascorbic acid plus polyethylene glycol.,"BACKGROUND/AIMS


Oral sulfate solution (OSS) is an emerging cleansing agent for bowel preparation. However, data comparing OSS to other conventional bowel preparations in Asian patients are limited. Therefore, the objective of this study was to compare the efficacy and tolerability of OSS to ascorbic acid plus polyethylene glycol (AA + PEG) in Asian patients.
METHODS


This was a prospective, randomized, parallel, investigator-blind study performed in two university hospitals in Korea. Bowel preparation efficacy was evaluated using both the Ottawa Bowel Preparation Scale (OBPS) and Boston Bowel Preparation Scale (BBPS).
RESULTS


Among 173 patients, 86 received OSS while 87 received AA + PEG for bowel preparation. Total OBPS score was 2.80 ± 2.48 in the OSS group and 4.49 ± 3.08 in the AA + PEG group, indicating significantly (p < 0.001) better efficacy with OSS. Total BBPS was higher in the OSS group (7.43 ± 1.49 vs. 6.51 ± 1.76, p < 0.001), indicating superior bowel preparation quality with OSS. Preparation-related adverse events were generally acceptable. Patients receiving OSS had more nausea (1.92 ± 0.94 vs. 1.54 ± 0.76, p = 0.004) and abdominal cramping (1.45 ± 0.78 vs. 1.17 ± 0.51, p = 0.006) than those receiving AA + PEG. However, overall satisfaction and taste were similar between the two groups.
CONCLUSION


OSS had a non-inferior bowel cleansing efficacy than AA + PEG regardless of colon segment.",2020,"Patients receiving OSS had more nausea (1.92 ± 0.94 vs. 1.54 ± 0.76, p = 0.004) and abdominal cramping (1.45 ± 0.78 vs. 1.17 ± 0.51, p = 0.006) than those receiving AA + PEG.","['Asian patients', '173 patients', 'two university hospitals in Korea']","['ascorbic acid plus polyethylene glycol (AA + PEG', 'AA + PEG', 'Oral sulfate solution (OSS', 'OSS', 'oral sulfate solution and 2-L ascorbic acid plus polyethylene glycol']","['Total OBPS score', 'Total BBPS', 'efficacy and tolerability', 'overall satisfaction and taste', 'nausea', 'abdominal cramping', 'Bowel preparation efficacy', 'Ottawa Bowel Preparation Scale (OBPS) and Boston Bowel Preparation Scale (BBPS']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0222045'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}]",173.0,0.096813,"Patients receiving OSS had more nausea (1.92 ± 0.94 vs. 1.54 ± 0.76, p = 0.004) and abdominal cramping (1.45 ± 0.78 vs. 1.17 ± 0.51, p = 0.006) than those receiving AA + PEG.","[{'ForeName': 'Ki Hwan', 'Initials': 'KH', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Ji Ae', 'Initials': 'JA', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Beom Jae', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Moon Kyung', 'Initials': 'MK', 'LastName': 'Joo', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Yu Ra', 'Initials': 'YR', 'LastName': 'Sim', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Wonjae', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Taehyun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Ji Yoon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Ei Rie', 'Initials': 'ER', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Yoon Tae', 'Initials': 'YT', 'LastName': 'Jeen', 'Affiliation': 'Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Jong-Jae', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2017.275']
1149,32407901,A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial.,"OBJECTIVES


Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity.
DESIGN


This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs. cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019.
RESULTS


The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive.
CONCLUSIONS


To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02819570.",2020,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"['preterm pre-labor rupture of membranes', 'PPROM', '84 women with PPROM, from 12/2015-12/2019', 'preterm pre-labor rupture of membranes (PPROM']","['ampicillin\u2009+\u2009roxithromycin vs cefuroxime\u2009+\u2009roxithromycin', 'ampicillin\u2009+\u2009roxithromycin', 'cefuroxime\u2009+\u2009roxithromycin', 'prophylactic antibiotic regimen']","['K. pneumonia cultures', 'median latency period', 'Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0235839', 'cui_str': 'Fever of the newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",84.0,0.100097,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"[{'ForeName': 'Maya Frank', 'Initials': 'MF', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel. Electronic address: homesickid@yahoo.com.'}, {'ForeName': 'Inshirah', 'Initials': 'I', 'LastName': 'Sgayer', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miron', 'Affiliation': 'Department of Pediatrics A, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krencel', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Vered Fleisher', 'Initials': 'VF', 'LastName': 'Sheffer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Neonatal Intensive Care Unit, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Suraya Saied', 'Initials': 'SS', 'LastName': 'Idriss', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Sammour', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peleg', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Inbar Ben', 'Initials': 'IB', 'LastName': 'Shachar', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Rechnitzer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Clinical Microbiology Laboratory, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.005']
1150,30463434,Comparison of a Smartphone Otoscope and Conventional Otoscope in the Diagnosis and Management of Acute Otitis Media.,"Acute otitis media (AOM) is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. We assessed (1) the rates of antimicrobial prescribing by pediatric emergency department clinicians using a smartphone otoscope device as compared with a conventional otoscope and (2) clinician acceptability of the smartphone device. We conducted a randomized control study in children's hospital emergency departments over 6 months. More than 1500 encounters were analyzed. The odds of prescribing antibiotics after being given a diagnosis of AOM by clinicians assigned to the smartphone group was 11% higher than the conventional group (18.8% vs 18.0%, odds ratio = 1.106,  P  = .600). Eight (73%) of the 11 physicians in the smartphone group preferred the smartphone device over the conventional otoscope. Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.",2019,Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.,"['Acute otitis media (AOM', ""children's hospital emergency departments over 6 months"", 'Acute Otitis Media']","['smartphone otoscope', 'Smartphone Otoscope and Conventional Otoscope', 'smartphone otoscope device']","['odds of prescribing antibiotics', 'smartphone device']","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media (disorder)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0182098', 'cui_str': 'Otoscopes'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",,0.0406635,Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.,"[{'ForeName': 'K Ning', 'Initials': 'KN', 'LastName': 'Chan', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Silverstein', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Leah N', 'Initials': 'LN', 'LastName': 'Bryan', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'McCracken', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Wendalyn K', 'Initials': 'WK', 'LastName': 'Little', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Andi L', 'Initials': 'AL', 'LastName': 'Shane', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}]",Clinical pediatrics,['10.1177/0009922818812480']
1151,32408117,"Effects of saffron supplementation on glycemia and inflammation in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial study.","BACKGROUND


New evidence indicates that overproduction of pro-inflammatory cytokines is responsible for the development of diabetes difficulties. Some herbals such as saffron, may control inflammation and improve the hyperglycemic states in diabetic patients. Therefore, this investigation aimed to assess the effects of saffron supplementation on fasting glucose and inflammatory markers levels in patients with type2 diabetes mellitus (T2DM).
METHODS


In this randomized double-blind, placebo-controlled clinical trial, 60 T2DM patients were randomly assigned into two groups as saffron and placebo (n = 30) receiving 100 mg/day saffron powder or starch capsules (1 capsule) for a duration of 8 weeks. Fasting blood sample was collected at baseline and at the end of the intervention. Fasting blood glucose (FBG) was immediately analyzed by the auto-analyzer. The serum level of Interleukin -6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10) were measured using ELISA assay by laboratory kits. Also, Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level.
RESULTS


Saffron supplementation significantly decreased the FBG levels within 8 weeks compared to placebo (130.93 ± 21.21 vs 135.13 ± 23.03 mg/dl, P = 0.012). Moreover, the serum level of TNF-α notably reduced in the saffron group compared to the placebo group (114.40 ± 24.28 vs 140.90 ± 25.49 pg/ml, P < 0.001). Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
CONCLUSION


In our study, it was indicated that saffron modulates glucose levels as well as inflammation status in T2DM patients through decreasing the expressions levels of some inflammatory mediators. Also, further investigations are necessary to confirm the positive effects of saffron as a complementary therapy for T2DM patients.",2020,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","['60 T2DM patients', 'patients with type 2 diabetes mellitus', 'patients with type2 diabetes mellitus (T2DM', 'diabetic patients', 'T2DM patients']","['saffron supplementation', 'saffron and placebo (n\xa0=\xa030) receiving 100\xa0mg/day saffron powder or starch capsules', 'placebo']","['IL-6 mRNA levels', 'hyperglycemic states', 'glycemia and inflammation', 'Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level', 'FBG levels', 'expressions of TNF-α', 'fasting glucose and inflammatory markers levels', 'Fasting blood glucose (FBG', 'serum level of Interleukin\xa0-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10', 'serum level of TNF-α', 'Fasting blood sample']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.491142,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aynaz', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pharmacology School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meisam', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Cellular and Molecular Nutrition, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Students Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Houshyar', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: roshanravann@tbzmed.ac.ir.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: mesrialamdari.n@tak.iums.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.031']
1152,30674240,Extended Efficacy of Low-Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Intermediate-Risk Kidney Transplant Recipients: Two-Year Follow-Up.,"OBJECTIVES


In a previous study, we evaluated 1-year outcomes of using low-dose valganciclovir prophylaxis for cytomegalovirus infection in intermediate-risk kidney transplant recipients. Whether this effect persists in the long term is unknown. We aimed to evaluate the 2-year follow up of such adopted prophylaxis.
MATERIALS AND METHODS


We randomized 2 matched groups of kidney transplant recipients (1:1) to receive valganciclovir as 450 mg daily (group 1) or 900 mg daily (group 2) for the first 6 months after kidney transplant. The final analysis included 196 patients as intermediate-risk patients (98 in each treatment group) after exclusion of 5 high-risk patients. Serologically, all patients were at moderate risk for cytomegalovirus infection. Long-term outcomes including cytomegalovirus disease, acute rejection, new-onset diabetes after transplant, graft loss, and patient survival were assessed.
RESULTS


Through year 2 of follow-up, cytomegalovirus infection was reported in only 1 patient in group 1 (at month 13) and 1 patient in group 2 (at month 19) (not significant). Biopsy-proven acute rejection episodes were not statistically different between the groups (2 episodes in group 1 and 6 in group 2; P = .431). New-onset diabetes posttransplant was reported in 8.1% in group 1 and 13.2% in group 2 (P = .535). Graft failure was equal in both groups (1 in each group) at 2 years of follow up (not significant). Patient survival was comparable in both groups (100% in group 1 versus 97.9% in group 2; P = .661). The total number of cytomegalovirus infections at 2 years was numerically less in group 1 (P = .128).
CONCLUSIONS


Low-dose valganciclovir prophylaxis for 6 months was associated with sustained reduction of cytomegalovirus infection up to 2 years after kidney transplant without significant impact on the acute rejection, new-onset diabetes posttransplant, or patient and graft outcomes.",2019,"The total number of cytomegalovirus infections at 2 years was numerically less in group 1 (P = .128).
","['We randomized 2 matched groups of kidney transplant recipients (1:1) to receive', 'intermediate-risk kidney transplant recipients', 'Intermediate-Risk Kidney Transplant Recipients', '196 patients as intermediate-risk patients (98 in each treatment group) after exclusion of 5 high-risk patients']","['Low-Dose Valganciclovir', 'valganciclovir', 'low-dose valganciclovir prophylaxis']","['total number of cytomegalovirus infections', 'Graft failure', 'cytomegalovirus infection', 'Biopsy-proven acute rejection episodes', 'cytomegalovirus disease, acute rejection, new-onset diabetes after transplant, graft loss, and patient survival', 'New-onset diabetes posttransplant', 'Patient survival']","[{'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",2.0,0.0212798,"The total number of cytomegalovirus infections at 2 years was numerically less in group 1 (P = .128).
","[{'ForeName': 'Medhat A', 'Initials': 'MA', 'LastName': 'Halim', 'Affiliation': 'The Department of Medicine, Hamed Al-Essa Organ Transplantation Centre, Ibn Sina Hospital, Kuwait.'}, {'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Gheith', 'Affiliation': ''}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Makkeya', 'Affiliation': ''}, {'ForeName': 'Ayman M', 'Initials': 'AM', 'LastName': 'Nagib', 'Affiliation': ''}, {'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Atta', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Emam', 'Affiliation': ''}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Yehia', 'Affiliation': ''}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Said', 'Affiliation': ''}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Nair', 'Affiliation': ''}, {'ForeName': 'Torki', 'Initials': 'T', 'LastName': 'Al-Otaibi', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2018.0020']
1153,30614315,The use of Zhukovsky vaginal and intrauterine balloons to improve the outcome of postpartum hysterectomies in patients with severe bleeding.,"Aim:  To assess the efficacy of a Zhukovsky obstetric double balloon for improving outcomes in women undergoing hysterectomy for postpartum hemorrhage. Materials and methods:  This was a randomized controlled study. Participants were divided into two groups to undergo insertion of a Zhukovsky obstetric double balloon prior to hysterectomy ( n  = 16) or conventional hysterectomy ( n  = 25). Results:  The main reasons for major obstetric hemorrhage were placenta accreta (53.6%), uterine atony (26.8%), uteroplacental apoplexy (14.6%), and amniotic fluid embolism (4.8%). The use of a Zhukovsky obstetric double balloon during postpartum hysterectomy was associated with a 1.7-fold reduction in blood loss and a 2.3-fold reduction in blood loss > 2000 ml compared with conventional hysterectomy. Conclusion:  The use of a Zhukovsky obstetric double balloon represents a potent tool for improvement of immediate outcomes of hysterectomy in women with severe postpartum bleeding.",2020,The use of a Zhukovsky obstetric double balloon represents a potent tool for improvement of immediate outcomes of hysterectomy in women with severe postpartum bleeding.,"['women undergoing hysterectomy for postpartum hemorrhage', 'women with severe postpartum bleeding', 'patients with severe bleeding']","['Zhukovsky obstetric double balloon', 'Zhukovsky obstetric double balloon prior to hysterectomy (n\u2009=\u200916) or conventional hysterectomy', 'Zhukovsky vaginal and intrauterine balloons']","['blood loss', 'uteroplacental apoplexy', 'major obstetric hemorrhage were placenta accreta', 'amniotic fluid embolism']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0221379', 'cui_str': 'Couvelaire uterus (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0032044', 'cui_str': 'Placenta Accreta'}, {'cui': 'C0013927', 'cui_str': 'Embolism, Amniotic Fluid'}]",,0.235579,The use of a Zhukovsky obstetric double balloon represents a potent tool for improvement of immediate outcomes of hysterectomy in women with severe postpartum bleeding.,"[{'ForeName': 'Sergey V', 'Initials': 'SV', 'LastName': 'Barinov', 'Affiliation': 'Russian Ministry of Health, Federal State Budget Educational Institution of Higher Education Omsk State Medical University, Omsk, Russia.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Medjannikova', 'Affiliation': 'Russian Ministry of Health, Federal State Budget Educational Institution of Higher Education Omsk State Medical University, Omsk, Russia.'}, {'ForeName': 'Yuliya I', 'Initials': 'YI', 'LastName': 'Tirskaya', 'Affiliation': 'Russian Ministry of Health, Federal State Budget Educational Institution of Higher Education Omsk State Medical University, Omsk, Russia.'}, {'ForeName': 'Vladimir D', 'Initials': 'VD', 'LastName': 'Chuprinin', 'Affiliation': 'Ministry of Health of Russia, National Medical Research Center of Obstetrics, Gynecology and Perinatology, Moscow, Russia.'}, {'ForeName': 'Elena G', 'Initials': 'EG', 'LastName': 'Khilkevich', 'Affiliation': 'Ministry of Health of Russia, National Medical Research Center of Obstetrics, Gynecology and Perinatology, Moscow, Russia.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Savelyeva', 'Affiliation': 'Russian Ministry of Health, Federal State Budget Educational Institution of Higher Education Omsk State Medical University, Omsk, Russia.'}, {'ForeName': 'Inna V', 'Initials': 'IV', 'LastName': 'Shamina', 'Affiliation': 'Russian Ministry of Health, Federal State Budget Educational Institution of Higher Education Omsk State Medical University, Omsk, Russia.'}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Borisova', 'Affiliation': 'Russian Ministry of Health, Federal State Budget Educational Institution of Higher Education Omsk State Medical University, Omsk, Russia.'}, {'ForeName': 'Oksana V', 'Initials': 'OV', 'LastName': 'Lazareva', 'Affiliation': 'Russian Ministry of Health, Federal State Budget Educational Institution of Higher Education Omsk State Medical University, Omsk, Russia.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1566309']
1154,31576513,The effect of midazolam as premedication on the quality of postoperative recovery after laparotomy: a randomized clinical trial.,"PURPOSE


Despite the uncertain effects of anxiolytic premedication with benzodiazepines on the quality of postoperative recovery, perioperative benzodiazepine administration is still a common practice in many hospitals. We evaluated the effect of premedication with midazolam on the quality of recovery in hospitalized patients undergoing a laparotomy.
METHODS


We conducted a single-centre randomized placebo-controlled, double-blinded clinical trial from July 2014 to September 2015. We included 192 patients aged > 18 yr scheduled for elective laparotomy with a planned postoperative stay of ≥ three days. Participants were randomized into two groups to receive either midazolam 3 mg or sodium chloride 0.9% intravenously as premedication prior to surgery. Patients were followed up for up to one week after surgery. The primary outcome was the Quality of Recovery-40 (QoR-40) score on postoperative day (POD) 3. The secondary outcomes included the QoR-40 score on POD 7, and the State-Trait Anxiety Inventory, State-Trait Anger Scale, Multidimensional Fatigue Inventory, and the Hospital Anxiety and Depression Scale scores.
RESULTS


The mean (standard deviation) postoperative QoR-40 scores on POD 3 were not significantly different in the midazolam group compared with controls [166.4 (17.0) vs 163.9 (19.8), respectively; mean difference, 2.3; 95% confidence interval, - 2.9 to 8.4; P = 0.35]. There were no between-group differences in any of the secondary outcomes.
CONCLUSIONS


Administration of midazolam as premedication for laparotomy patients did not improve the quality of recovery up to one week after surgery. General prescription of midazolam as premedication can be questioned and might only suit some patients.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT01993459); registered 29 October, 2013.",2020,"The mean (standard deviation) postoperative QoR-40 scores on POD 3 were not significantly different in the midazolam group compared with controls [166.4 (17.0) vs 163.9 (19.8), respectively; mean difference, 2.3; 95% confidence interval, - 2.9 to 8.4; P = 0.35].","['hospitalized patients undergoing a laparotomy', 'laparotomy patients', '192 patients aged > 18 yr scheduled for elective laparotomy with a planned postoperative stay of ≥ three days', 'July 2014 to September 2015', 'after laparotomy']","['placebo', 'midazolam 3 mg or sodium chloride 0.9% intravenously as premedication prior to surgery', 'midazolam', 'benzodiazepines']","['quality of recovery', 'QoR-40 score on POD 7, and the State-Trait Anxiety Inventory, State-Trait Anger Scale, Multidimensional Fatigue Inventory, and the Hospital Anxiety and Depression Scale scores', 'quality of postoperative recovery', 'mean (standard deviation) postoperative QoR-40 scores on POD 3', 'Quality of Recovery-40 (QoR-40) score on postoperative day (POD) 3']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0222045'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",192.0,0.568403,"The mean (standard deviation) postoperative QoR-40 scores on POD 3 were not significantly different in the midazolam group compared with controls [166.4 (17.0) vs 163.9 (19.8), respectively; mean difference, 2.3; 95% confidence interval, - 2.9 to 8.4; P = 0.35].","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'van Beek', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands. s.vanbeek@erasmusmc.nl.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kroon', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Rijs', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Hendrik-Jan', 'Initials': 'HJ', 'LastName': 'Mijderwijk', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Klimek', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Stolker', 'Affiliation': 'Department of Anesthesiology, Erasmus University Medical Centre, PO 2040, 3000 CA, Rotterdam, The Netherlands.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01494-6']
1155,31585191,S. aureus colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine.,"OBJECTIVES


Assess Staphylococcus aureus (S. aureus) colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine (SA3Ag).
METHODS


In this phase 1, double-blind, sponsor-unblinded study, participants were randomized to receive a single dose (1 of 3 dose levels) of SA3Ag or placebo and a booster dose or placebo at 6 months. S. aureus isolates from nasal, perineal, and oropharyngeal swabs before and through 12 months post-vaccination were identified.
RESULTS


Baseline S. aureus colonization prevalence was 30.6% (any site), with nasal carriage (27.0%) more common than oropharyngeal/perineal (3.2% each). Following initial vaccination (low-dose: 102; mid-dose: 101; high-dose: 101; placebo: 102) and booster (low-dose: 45; mid-dose: 44; high-dose: 27; placebo: 181), placebo and SA3Ag groups showed similar S. aureus carriage through 12 months. Most colonized participants (74.0%) were colonized by single spa types. Placebo and SA3Ag groups had similar persistence of colonization, with 19.6-30.7% due to single spa types. Acquisition was observed in mid- and high-dose recipients (∼20%) and low-dose and placebo recipients (∼12%). Vaccination resulted in substantial increases in antibodies to all 3 antigens, irrespective of carriage status.
CONCLUSIONS


Based on descriptive analyses of this small study, SA3Ag vaccination did not impact S. aureus acquisition or carriage. Carriage status did not impact antibody responses to SA3Ag.",2019,"Vaccination resulted in substantial increases in antibodies to all 3 antigens, irrespective of carriage status.
","['Healthy Australian Adults Receiving an Investigational S. aureus 3-antigen Vaccine', 'healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine (SA3Ag']","['placebo', 'Placebo', 'SA3Ag or placebo and a booster dose or placebo']","['Acquisition', 'persistence of colonization', 'nasal carriage', 'colonization prevalence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.635179,"Vaccination resulted in substantial increases in antibodies to all 3 antigens, irrespective of carriage status.
","[{'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Marshall', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital and Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia. Electronic address: helen.marshall@adelaide.edu.au.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baber', 'Affiliation': 'Pfizer Australia Pty Ltd, Sydney, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Richmond', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia Division of Paediatrics & Vaccine Trials Group, Perth, WA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nissen', 'Affiliation': ""Queensland Paediatric Infectious Diseases Laboratory, Children's Health Research Centre, University of Queensland, Queensland Children's Hospital, South Brisbane, Qld, Australia.""}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Shakib', 'Affiliation': 'Department of Clinical Pharmacology, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Barry N', 'Initials': 'BN', 'LastName': 'Kreiswirth', 'Affiliation': 'Public Health Research Institute, Rutgers University, Newark, NJ, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Zito', 'Affiliation': 'Pfizer Vaccine Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Severs', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eiden', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gruber', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'C Hal', 'Initials': 'CH', 'LastName': 'Jones', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Annaliesa S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, NY, USA.'}]",The Journal of infection,['10.1016/j.jinf.2019.09.018']
1156,30457934,Impact of early telephone contact on 3-month follow-up rates following residential drug and alcohol treatment: A randomized controlled trial.,"Background:  Routine outcome monitoring (ROM) is an important component of service provision and qualitity assurance procedures. However, a major logistical and financial challenge for organizations is successfully following up participants once they have left residential alcohol and other drug treatment. The aim of the current study was to assess the impact and effectiveness of an ""early"" follow-up contact and brief interview on subsequent 3-month ROM follow-up success.  Methods:  Participants were 800 clients attending specialist residential alcohol and other drug treatment provided by The Salvation Army. As part of routine outcome assessment procedures, all people attending these programs are asked to complete a 3-month follow-up assessment. Participants were randomly allocated either to the early contact condition (i.e., ""early"" 2-week follow - up contact prior to the 3-month follow-up assessment) or to the control condition (i.e., no ""early"" 2-week follow-up prior to the 3-month follow-up assessment). The primary outcomes were the proportion of participants who were followed up and surveyed at 3 months.  Results:  There were significantly higher follow-up rates at 3 months post discharge for participants in the early contact group (55.6%) compared with the control condition (46.1%). Although there were higher rates of 3-month follow-up for participants in the early contact group, rates of successful survey completion were not significantly different between the 2 groups.  Conclusions:  Including an early 2-week telephone call prior to the 3-month assessment increased the number of participants we were able to follow up at 3 months post discharge but did not improve the rate of survey participation at 3 months. The additional costs associated with this activity and the modest increase in follow-up rates need to be considered prior to organizations investing in these follow-up enhancement activities.",2019,There were significantly higher follow-up rates at 3 months post discharge for participants in the early contact group (55.6%) compared with the control condition (46.1%).,['Participants were 800 clients attending specialist residential alcohol and other drug treatment provided by The Salvation Army'],"['early contact condition (i.e., ""early"" 2-week follow-up contact prior to the 3-month follow-up assessment) or to the control condition (i.e., no ""early"" 2-week follow-up prior to the 3-month follow-up assessment', 'early"" follow-up contact and brief interview']","['rates of successful survey completion', 'rate of survey participation']","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",800.0,0.0596181,There were significantly higher follow-up rates at 3 months post discharge for participants in the early contact group (55.6%) compared with the control condition (46.1%).,"[{'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'School of Psychology, Illawarra Institute for Mental Health, University of Wollongong , Wollongong , New South Wales , Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Blackman', 'Affiliation': 'School of Psychology, Illawarra Institute for Mental Health, University of Wollongong , Wollongong , New South Wales , Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'School of Psychology, Illawarra Institute for Mental Health, University of Wollongong , Wollongong , New South Wales , Australia.'}]",Substance abuse,['10.1080/08897077.2018.1528494']
1157,31721979,Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


After the occurrence of nonfatal cardiovascular events, recurrent events are highly likely. Most cardiovascular outcomes trials analyze first events only; extending analyses to first and recurrent (total) events can provide clinically meaningful information.
Objective


To investigate whether liraglutide is associated with reduced first and recurrent total major adverse cardiovascular events (MACE) compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events.
Design, Setting, and Participants


This post hoc analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) randomized, double-blind, clinical trial included data from patients with type 2 diabetes who had established or were at high risk for cardiovascular disease at 410 sites in 32 countries from August 2010, to December 2015. Data analysis was performed from August 15, 2016, to July 5, 2019.
Interventions


Patients were randomized 1:1 to receive liraglutide (up to 1.8 mg per day) or placebo, both with standard care, for 3.5 to 5.0 years.
Main Outcomes and Measures


Assessed outcomes were MACE (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), expanded MACE (primary MACE plus coronary revascularization and hospitalization for heart failure or unstable angina pectoris), and the individual end points.
Results


The 9340 LEADER trial participants (6003 [64.3%] male; mean [SD] age, 64.3 [7.2] years) experienced 1605 total MACE (1302 first and 303 recurrent events; median follow-up, 3.8 years [range, 0-5.2 years]). Patients who experienced any MACE were older (1 MACE: mean [SD] age, 65.6 [8.0] years; >1 MACE: 65.7 [7.9] years) and had diabetes for longer duration (1 MACE: mean [SD] duration, 13.4 [8.3] years; >1 MACE: 14.4 [8.7] years) compared with patients without MACE (mean [SD] age, 64.1 [7.1] years; mean [SD] duration, 12.7 [7.9] years). Fewer first and recurrent MACE occurred in the liraglutide group (n = 4668; 608 first and 127 recurrent events) than in the placebo group (n = 4672; 694 first and 176 recurrent events). Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo. For most individual cardiovascular end points, liraglutide was associated with lower risk vs placebo.
Conclusions and Relevance


These results suggest that liraglutide treatment is associated with reduced total MACE compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events. This analysis supports the findings of an absolute benefit of liraglutide treatment with respect to the overall burden of cardiovascular events in this high-risk patient population.
Trial Registration


ClinicalTrials.gov identifier: NCT01179048.",2019,"Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo.","['patients with type 2 diabetes and high risk of cardiovascular events', 'The 9340 LEADER trial participants (6003 [64.3%] male; mean [SD] age, 64.3 [7.2] years) experienced 1605 total MACE (1302 first and 303 recurrent events; median follow-up, 3.8 years [range, 0-5.2 years', 'patients without MACE (mean [SD] age, 64.1 [7.1] years; mean [SD] duration, 12.7 [7.9] years', 'patients with type 2 diabetes who had established or were at high risk for cardiovascular disease at 410 sites in 32 countries from August 2010, to December 2015', 'Diabetes', 'Patients With Type', 'Patients who experienced any MACE were older (1 MACE: mean [SD] age, 65.6 [8.0] years; >1 MACE: 65.7 [7.9] years) and had diabetes for longer duration (1 MACE: mean [SD] duration, 13.4 [8.3] years', '2 Diabetes and High Risk of Cardiovascular Events']","['placebo', 'liraglutide', 'Liraglutide']","['total expanded MACE', 'MACE (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), expanded MACE (primary MACE plus coronary revascularization and hospitalization for heart failure or unstable angina pectoris), and the individual end points', 'Occurence of First and Recurrent Major Adverse Cardiovascular Events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.134549,"Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo.","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, United Kingdom.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ørsted', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}]",JAMA cardiology,['10.1001/jamacardio.2019.3080']
1158,30395180,Simplifying the World Health Organization Protocol: 3 Steps Versus 6 Steps for Performance of Hand Hygiene in a Cluster-randomized Trial.,"BACKGROUND


In an experimental setting, a simplified, 3-step hand hygiene technique for applying alcohol-based hand rub was non inferior in terms of reduction of bacterial counts, as compared to the conventional World Health Organization 6-step technique. We therefore compared compliance and microbiological efficacy between both hand hygiene techniques in routine clinical practice.
METHODS


We performed a cluster-randomized trial from October-November 2015 at the University Hospital Basel, Switzerland: a tertiary, academic care center (ISRCTN45923734). We randomly assigned 12 wards to either the 3-step technique or the conventional 6-step technique of hand rubbing. The primary endpoints were compliance with the assigned technique and reduction of bacterial counts on the hands of health-care workers.
RESULTS


Overall, 2923 hand hygiene indications were observed, and compliance was 70.7% (2066/2923). Compliance with technique and indications was 51.7% (595/1151) and 75.9% (1151/1516) on wards assigned to the 3-step technique, respectively, as compared to 12.7% (116/915) and 65.0% (915/1407) on wards assigned to the 6-step technique (P < .001). The reduction factor (RF) of bacterial colony counts did not differ between techniques (median RF 0.97 log10 colony-forming units [CFU] [interquartile range 0.39-1.59] for the 3-step technique vs median RF 1.04 log10 CFU [interquartile range 0.49-1.52] for the 6-step technique; P = .629).
CONCLUSIONS


In a clinical setting, the simpler hand hygiene technique, consisting of 3 steps, resulted in higher compliance with both hand hygiene indications and technique, as compared to the 6 steps. As the results of the microbiological analyses exclude inferiority, the conventional 6 steps could be safely replaced by a simpler hand hygiene technique.
CLINICAL TRIALS REGISTRATION


ISRCTN45923734.",2019,"The reduction factor (RF) of bacterial colony counts did not differ between both techniques (median RF 0.97 log10 CFU, IQR 0.39-1.59 for the 3-step technique vs. median RF 1.04 log10 CFU, IQR 0.49-1.52 for the 6-step technique, p=0.629).
","['10/2015-11/2015 at the University Hospital Basel, Switzerland - a tertiary academic care center (ISRCTN45923734']",['3-step technique or the conventional 6-step technique for use of hand rub'],"['bacterial counts on hands of healthcare workers', 'reduction factor (RF) of bacterial colony counts']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0004618', 'cui_str': 'Bacterial Count'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}]",12.0,0.0571497,"The reduction factor (RF) of bacterial colony counts did not differ between both techniques (median RF 0.97 log10 CFU, IQR 0.39-1.59 for the 3-step technique vs. median RF 1.04 log10 CFU, IQR 0.49-1.52 for the 6-step technique, p=0.629).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tschudin-Sutter', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sepulcri', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dangel', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ulrich', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Switzerland.'}, {'ForeName': 'Reno', 'Initials': 'R', 'LastName': 'Frei', 'Affiliation': 'Division of Clinical Microbiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Andreas F', 'Initials': 'AF', 'LastName': 'Widmer', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy948']
1159,30517622,Mid-term results of a randomized trial of tricuspid annuloplasty for less-than-severe functional tricuspid regurgitation at the time of mitral valve surgery†.,"OBJECTIVES


The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both centre specific and surgeon specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.
METHODS


A single-centre randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated with or without tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up and cardiac magnetic resonance. The primary outcome was freedom from more than or equal to moderate tricuspid regurgitation with vena contracta ≥4 mm. Secondary outcomes were maximal oxygen uptake and right ventricular (RV) dimension and function.
RESULTS


A total of 53 patients were allocated to receive concomitant TVP+, and 53 patients were treated conservatively (TVP-). At 5 years, tricuspid regurgitation was observed to be greater than mild in 10 patients in the TVP- group and no patients in the TVP+ group (P < 0.01). Maximal oxygen uptake, RV basal diameter, end-diastolic diameter and end-systolic diameter and fractional area changes were similar in both groups. Cardiac magnetic resonance confirmed no differences in RV end-diastolic volume, RV end-systolic volume and RV ejection fraction.
CONCLUSIONS


This single-centre prospective randomized trial demonstrated that prophylactic tricuspid annuloplasty irrespective of annular dilatation at the time of mitral surgery reduced the recurrence of moderate or severe FTR at 5-year follow-up and reduced the pulmonary pressure. Nevertheless, the functional capacity, the RV function and the RV dimension remained similar.",2019,"Maximal oxygen uptake, RV basal diameter, end-diastolic diameter and end-systolic diameter and fractional area changes were similar in both groups.","['patients with less-than-severe FTR undergoing mitral valve surgery to be', '53 patients', 'for less-than-severe functional tricuspid regurgitation at the time of mitral valve surgery†']","['concomitant TVP', 'treated conservatively (TVP', 'prophylactically treated with or without tricuspid valve annuloplasty (TVP- or TVP', 'functional tricuspid regurgitation (FTR', 'tricuspid annuloplasty', 'TVP', 'prophylactic tricuspid annuloplasty']","['recurrence of moderate or severe FTR', 'freedom from more than or equal to moderate tricuspid regurgitation with vena contracta ≥4\u2009mm', 'functional capacity, the RV function and the RV dimension', 'maximal oxygen uptake and right ventricular (RV) dimension and function', 'Maximal oxygen uptake, RV basal diameter, end-diastolic diameter and end-systolic diameter and fractional area changes', 'RV end-diastolic volume, RV end-systolic volume and RV ejection fraction', 'tricuspid regurgitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0340392', 'cui_str': 'Functional tricuspid regurgitation (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0040960', 'cui_str': 'Tricuspid Valve'}, {'cui': 'C0190165', 'cui_str': 'Reconstruction of annulus of cardiac valve (procedure)'}, {'cui': 'C0340392', 'cui_str': 'Functional tricuspid regurgitation (disorder)'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid Regurgitation'}, {'cui': 'C2732913', 'cui_str': 'Vena contracta (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",53.0,0.064555,"Maximal oxygen uptake, RV basal diameter, end-diastolic diameter and end-systolic diameter and fractional area changes were similar in both groups.","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pettinari', 'Affiliation': 'Cardiac Surgery Department, Ziekenhuis Oost Limburg, Genk, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'De Kerchove', 'Affiliation': 'Cardiac Surgery Department, Universitair Clinique St. Luc, Brussel, Belgium.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Lazam', 'Affiliation': 'Cardiology Department, Universitair Clinique St. Luc, Brussel, Belgium.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Pasquet', 'Affiliation': 'Cardiology Department, Universitair Clinique St. Luc, Brussel, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Cardiology Department, Universitair Clinique St. Luc, Brussel, Belgium.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vanoverschelde', 'Affiliation': 'Cardiology Department, Universitair Clinique St. Luc, Brussel, Belgium.'}, {'ForeName': 'Gebrine', 'Initials': 'G', 'LastName': 'El-Khoury', 'Affiliation': 'Cardiac Surgery Department, Universitair Clinique St. Luc, Brussel, Belgium.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezy378']
1160,30504510,Cost-effective Tapering Algorithm in Patients with Rheumatoid Arthritis: Combination of Multibiomarker Disease Activity Score and Autoantibody Status.,"OBJECTIVE


To analyze the effect of a risk-stratified disease-modifying antirheumatic drug (DMARD)-tapering algorithm based on multibiomarker disease activity (MBDA) score and anticitrullinated protein antibodies (ACPA) on direct treatment costs for patients with rheumatoid arthritis (RA) in sustained remission.
METHODS


The study was a posthoc retrospective analysis of direct treatment costs for 146 patients with RA in sustained remission tapering and stopping DMARD treatment, in the prospective randomized RETRO study. MBDA scores and ACPA status were determined in baseline samples of patients continuing DMARD (arm 1), tapering their dose by 50% (arm 2), or stopping after tapering (arm 3). Patients were followed over 1 year, and direct treatment costs were evaluated every 3 months. MBDA and ACPA status were used as predictors creating a risk-stratified tapering algorithm based on relapse rates.
RESULTS


RA patients with a low MBDA score (< 30 units) and negative ACPA showed the lowest relapse risk (19%), while double-positive patients showed high relapse risk (61%). In ACPA-negative and MBDA-negative (< 30 units), and ACPA or MBDA single-positive (> 30 units) groups, DMARD tapering appears feasible. Considering only patients without flare, direct costs for synthetic and biologic DMARD in the ACPA/MBDA-negative and single positive groups (n = 41) would have been €372,245.16 for full-dose treatment over 1 year. Tapering and stopping DMARD in this low-risk relapse group allowed a reduction of €219,712.03 of DMARD costs. Average reduction of DMARD costs per patient was €5358.83.
CONCLUSION


Combining MBDA score and ACPA status at baseline may allow risk stratification for successful DMARD tapering and cost-effective use of biologic DMARD in patients in deep remission as defined by the 28-joint count Disease Activity Score using erythrocyte sedimentation rate.",2019,"RESULTS


RA patients with a low MBDA score (< 30 units) and negative ACPA showed the lowest relapse risk (19%), while double-positive patients showed high relapse risk (61%).","['146 patients with RA in sustained remission tapering and stopping DMARD treatment', 'patients with rheumatoid arthritis (RA) in sustained remission', 'Patients with Rheumatoid Arthritis']",[],"['DMARD costs', 'relapse risk', 'multibiomarker disease activity (MBDA) score and anticitrullinated protein antibodies (ACPA', 'lowest relapse risk', 'Combining MBDA score and ACPA status', 'low MBDA score', 'MBDA scores and ACPA status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]",[],"[{'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0636836', 'cui_str': 'MBDA'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",146.0,0.021541,"RESULTS


RA patients with a low MBDA score (< 30 units) and negative ACPA showed the lowest relapse risk (19%), while double-positive patients showed high relapse risk (61%).","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hagen', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Englbrecht', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Haschka', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Reiser', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Kleyer', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hueber', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Manger', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Figueiredo', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Jayme Fogagnolo', 'Initials': 'JF', 'LastName': 'Cobra', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Tony', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Finzel', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kleinert', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Wendler', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schuch', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Ronneberger', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feuchtenberger', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fleck', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Manger', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Ochs', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Hans-Martin', 'Initials': 'HM', 'LastName': 'Lorenz', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Nüsslein', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Henes', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Krüger', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schett', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rech', 'Affiliation': 'From the Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Department of Internal Medicine 3 - Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany; St. Vincent Hospital, Vinforce Study Group, Medical University of Vienna, Vienna, Austria; Institutio de Rheumatologia, São Paolo, Brazil; University of Würzburg, Internal Medicine 2, Würzburg; University Medical Center Freiburg, Rheumatology and Clinical Immunology, Freiburg; Rheumatology Clinical Practice Erlangen, Erlangen; Rheumatology Practice and Department of Internal Medicine 2, Clinic Burghausen, Burghausen; Asklepios Medical Center, Department of Rheumatology and clinical Immunology, Bad Abbach; Rheumatology Practice Bamberg, Bamberg; Rheumatology Practice Bayreuth, Bayreuth; University of Heidelberg, Medicine 5, Heidelberg; Rheumatology Practice Nuremberg, Nuremberg; Schlosspark Klinik, Internal Medicine/Rheumatology, Berlin; University of Tübingen, Centre for Interdisciplinary Clinical Immunology, Tübingen; Praxiszentrum St. Bonifatius, Munich, Germany. juergen.rech@uk-erlangen.de.'}]",The Journal of rheumatology,['10.3899/jrheum.180028']
1161,30497085,Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design.,"INTRODUCTION


Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance.
MATERIALS AND METHODS


PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years.
DISCUSSION


PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.",2020,"INTRODUCTION


Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches.","['patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years', 'Aortic Valve Replacement', 'patients undergoing SAVR in the presence of severe aortic stenosis']","['standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting', 'Sutureless versus Stented Bioprostheses', 'AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement', 'Perceval (LivaNova, London, UK) sutureless bioprosthesis']","['safety and efficacy', 'number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.0453639,"INTRODUCTION


Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorusso', 'Affiliation': 'Department of Cardio-Thoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC\u2009+\u2009), Maastricht, The Netherlands.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Folliguet', 'Affiliation': 'Chirurgie Cardiaque & Transplantation, Assistance Publique, Hôpital, Henri Mondor, Université Paris 12 UPEC, France.'}, {'ForeName': 'Malakh', 'Initials': 'M', 'LastName': 'Shrestha', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Meuris', 'Affiliation': 'Cardiac Surgery Department, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roselli', 'Affiliation': 'Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Klersy', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nozza', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Verhees', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Larracas', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Goisis', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Fischlein', 'Affiliation': 'Department of Cardiac Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0038-1675847']
1162,30412147,[The role of the combined balneotherapeutic treatment as the 'add-back therapy' against the background of the anti-hormonal effects of the agonists of gonadotropin-releasing hormone in the women suffering from endometriosis genitalis externa].,"BACKGROUND


The use of agonists of gonadotropin-releasing hormone (GnRH) for the rehabilitation treatment of the patients presenting with endometriosis genitalis externa is known to significantly enhance the risk of development of hypoestrogenism. The so-called 'add-back-therapy' is carried out as a preventive measure to eliminate hypoestrogenism caused by the intake of GnRH agonists without detriment to the effectiveness of anti-hormonal therapy.
AIM


The objective of the present study was to estimate the effectiveness of the new method ('add-back hormone replacement therapy') in comparison with anti-hormonal therapy with the use of GRH agonists at the stage of the early postoperative medical rehabilitation based on the drinking of mineral waters (MW) and radon therapy (RT) in the patients who had undergone the laparoscopic interventions for the treatment of endometrioid heterotopies of the ovaries (1-3 months post-operatively).
MATERIAL AND METHODS


To evaluate the effectiveness of the spa and health resort-based rehabilitation measures, the long-term effects of GnRH agonists have been studied in 2 groups of the patients formed by the of simple randomization method. The main group (MG) was comprised of 45 women received medical rehabilitation under conditions of a spa and health resort setting with the application of medium-salt water from the Pyatigorsk spring and radon therapy in the combination with triptorelin. The group of comparison (CG) was composed of 44 women given the treatment with the use of triptorelin under the out-patient conditions. The assessment of the results of the study included: the estimation of the intensity of pelvic pain syndrome, indicators of the hormonal status and the quality of life (QL), ultrasonic examination of the pelvic organs, and the occurrence of adverse effects of triptorelin. The duration of the study was 3 years (2014-2016).
RESULTS


The analysis of the long-term results of the rehabilitative treatment has demonstrated that the rehabilitation activities under the spa and health resort conditions within 1-3 months after the surgical intervention including the application of MW and RT in the combination with an agonist of gonadotropin-releasing hormone (triptorelin) greatly contributed to the stability of the results of the treatment: specifically, only 2.5% of the patients suffered the recurrence of cystic ovarian endometriosis whereas 24.5% (p<0.001) reported the restoration of the reproductive function. The patients comprising the control group experienced the recurrence of the pathologic process in 7.5% of the cases and the restoration of the reproductive function in 15.8% of the cases (p<0.001). Simultaneously, the quality of life in the patients in the main group improved 3.4 times on the average in comparison with the initial level (p<0.001). The 2.2-fold improvement of the quality of life was documented in the control patients (p<0.001). At the same time, the frequency of adverse reactions to the treatment with triptorelin in the control patients was higher than in the main group including pain in the epigastric area, headache, irritability, hyperhidrosis, and instability of arterial blood pressure (ABP) that significantly deteriorated the life quality in these women.
CONCLUSION


The comparative analysis of the results of the follow-up observations has demonstrated that the application of drinking mineral water and radon therapy for the treatment of the women suffering from endometriosis genitalis externa can be recommended as 'add-back therapy' against the background of anti-hormonal effects of agonists of gonadotropin-releasing hormone.",2018,The 2.2-fold improvement of the quality of life was documented in the control patients (p<0.001).,"['patients who had undergone the laparoscopic interventions for the treatment of endometrioid heterotopies of the ovaries (1-3 months post-operatively', 'patients presenting with endometriosis genitalis externa', 'women suffering from endometriosis genitalis externa']","['gonadotropin-releasing hormone (GnRH', ""new method ('add-back hormone replacement therapy"", 'drinking mineral water and radon therapy', 'medical rehabilitation under conditions of a spa and health resort setting with the application of medium-salt water from the Pyatigorsk spring and radon therapy in the combination with triptorelin', 'gonadotropin-releasing hormone', 'gonadotropin-releasing hormone (triptorelin', 'triptorelin', 'combined balneotherapeutic treatment']","['pain in the epigastric area, headache, irritability, hyperhidrosis, and instability of arterial blood pressure (ABP', 'frequency of adverse reactions', 'recurrence of cystic ovarian endometriosis', 'reproductive function', 'pelvic pain syndrome, indicators of the hormonal status and the quality of life (QL), ultrasonic examination of the pelvic organs', 'drinking of mineral waters (MW) and radon therapy (RT', 'quality of life', 'recurrence of the pathologic process']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0034629', 'cui_str': 'Radon'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018740', 'cui_str': 'Health Resorts'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0337055', 'cui_str': 'Salt water (substance)'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205207', 'cui_str': 'Cystic (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0232896', 'cui_str': 'Reproductive function'}, {'cui': 'C0152078', 'cui_str': 'Pelvic congestion syndrome (disorder)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0034629', 'cui_str': 'Radon'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030660', 'cui_str': 'Pathological Processes'}]",,0.0183901,The 2.2-fold improvement of the quality of life was documented in the control patients (p<0.001).,"[{'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Akhkubekova', 'Affiliation': 'Pyatigorsk state scientific research institute of balneotherapeiutics of Russian Federal Medical Biological Agency, Pyatigorsk, Russia'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Kaysinova', 'Affiliation': 'Pyatigorsk state scientific research institute of balneotherapeiutics of Russian Federal Medical Biological Agency, Pyatigorsk, Russia'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Fedorov', 'Affiliation': 'Ural state medical university, Ekaterinburg, Russia'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Efimenko', 'Affiliation': 'Pyatigorsk state scientific research institute of balneotherapeiutics of Russian Federal Medical Biological Agency, Pyatigorsk, Russia'}, {'ForeName': 'I I', 'Initials': 'II', 'LastName': 'Gaidamaka', 'Affiliation': 'North Ossetian state medical academy, Vladikavkaz, Russia'}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Chalaja', 'Affiliation': 'Pyatigorsk state scientific research institute of balneotherapeiutics of Russian Federal Medical Biological Agency, Pyatigorsk, Russia'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Cherevashchenko', 'Affiliation': 'Pyatigorsk state scientific research institute of balneotherapeiutics of Russian Federal Medical Biological Agency, Pyatigorsk, Russia'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Tsallagova', 'Affiliation': 'Institute of biomedical researches — branch of the Vladikavkaz scientific center of Russian Academy of Sciences, Vladikavkaz, Russia'}, {'ForeName': 'E E', 'Initials': 'EE', 'LastName': 'Urvacheva', 'Affiliation': 'Pyatigorsk state scientific research institute of balneotherapeiutics of Russian Federal Medical Biological Agency, Pyatigorsk, Russia'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Ovsienko', 'Affiliation': 'Pyatigorsk state scientific research institute of balneotherapeiutics of Russian Federal Medical Biological Agency, Pyatigorsk, Russia'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20189505131']
1163,31568799,Novel UL97 drug resistance mutations identified at baseline in a clinical trial of maribavir for resistant or refractory cytomegalovirus infection.,"In a Phase 2 clinical trial, 120 subjects with cytomegalovirus (CMV) infection refractory or resistant to standard therapy were randomized equally to 3 doses of oral maribavir treatment, and 70% achieved undetectable plasma CMV DNA within 12 weeks. At study entry, standard diagnostic UL97 genotyping was available for 71 subjects, with 60 (85%) revealing well-characterized ganciclovir resistance mutations that did not preclude a therapeutic response to maribavir. Central laboratory testing of a range of UL97 codons (288-468) not fully covered by standard genotyping was done on 93 subjects at baseline. This detected no previously known maribavir resistance mutations, but identified atypical mutations in 3 subjects, including a P-loop substitution F342Y, and ATP-binding region substitutions K359E/Q. By recombinant phenotyping, K359E and K359Q each conferred a nearly 4-fold increased ganciclovir 50% inhibitory concentration (EC50) without maribavir resistance, whereas F342Y conferred a 6-fold increased ganciclovir EC50 and a 4.5-fold increased maribavir EC50. The subject with F342Y detected at baseline did not achieve plasma CMV DNA clearance after 12 weeks of maribavir therapy and later developed an additional UL97 substitution H411Y known to confer 12- to 20-fold increased MBV EC50 by itself. The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold. Diagnostic genotyping of UL97 should be expanded to cover the ATP-binding region beginning at codon 335 to enable the detection of atypical resistance mutations and further correlation of their clinical significance.",2019,The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold.,"['71 subjects, with 60 (85%) revealing well-characterized ganciclovir resistance mutations that did not preclude a therapeutic response to maribavir', '120 subjects with cytomegalovirus (CMV) infection refractory or resistant to standard therapy']",['UL97 codons'],"['MBV EC50', 'maribavir EC50', 'plasma CMV DNA clearance']","[{'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009221', 'cui_str': 'Codon'}]","[{'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",120.0,0.0455351,The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold.,"[{'ForeName': 'Sunwen', 'Initials': 'S', 'LastName': 'Chou', 'Affiliation': 'Division of Infectious Diseases, Oregon Health and Science University, Department of Veterans Affairs Medical Center, Portland, Oregon, USA. Electronic address: chous@ohsu.edu.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}, {'ForeName': 'Kening', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}, {'ForeName': 'Tien', 'Initials': 'T', 'LastName': 'Bo', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}]",Antiviral research,['10.1016/j.antiviral.2019.104616']
1164,30657971,The Respiratory Specimen Collection Trial (ReSpeCT): A Randomized Controlled Trial to Compare Quality and Timeliness of Respiratory Sample Collection in the Home by Parents and Healthcare Workers From Children Aged <2 Years.,"BACKGROUND


Most acute respiratory infection (ARI) research focuses on severe disease and overlooks the burden of community-managed illness. For community-based studies, home-based specimen collection by parents could be a resource-saving alternative to collection by healthcare workers (HCWs). In this study, we compared parent and HCW groups for their likelihood to collect specimens and the timeliness and quality of such collection.
METHODS


In this unblinded randomized controlled trial, parents from Brisbane, Australia, were taught to identify new ARI episodes in their children aged <2 years. When their child had a new ARI, parents either collected a nasal swab from the child (P group) or contacted an HCW who visited to obtain a nasopharyngeal swab (HCW group). We compared the likelihood and timeliness of specimen collection and respiratory pathogen detection. A nested diagnostic study compared paired specimen collections from children in the HCW group.
RESULTS


Included were 76 incident ARI episodes from 31 children and 102 episodes from 33 children in the P and HCW groups, respectively. The proportions of ARIs for which a specimen was collected were similar (P group, 69.7%; HCW group, 72.5%; P = .77), and pathogens were detected in 93.8% and 77.5% of the specimens, respectively (P = .03). The period between ARI onset and specimen collection was shorter in the P group than in the HCW group (mean difference, 1.9 days [95% confidence interval, 0.7-3.0 days]; P < .001). For the 69 paired specimens, viral loads were lower in the parent-collected swabs (mean cycle threshold difference, 4.5 [95% confidence interval, 3.1-5.9]; P < .001).
CONCLUSIONS


Parents and HCWs obtained samples in similar proportions of ARI episodes, but the parents collected the samples fewer days after ARI onset and with a resulting higher likelihood of pathogen identification. This method can be used in population-based epidemiological studies of ARI as a resource-saving alternative.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT00966069.",2020,"The proportions of ARIs for which a specimen was collected were similar (P group, 69.7%; HCW group, 72.5%; P = .77), and pathogens were detected in 93.8% and 77.5% of the specimens, respectively (P = .03).","['children in the HCW group', 'parents from Brisbane, Australia, were taught to identify new ARI episodes in their children aged <2 years', 'Home by Parents and Healthcare Workers From Children Aged <2 Years']",['HCW'],"['ARI onset and specimen collection', 'proportions of ARIs', 'viral loads']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}]",[],"[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",31.0,0.186814,"The proportions of ARIs for which a specimen was collected were similar (P group, 69.7%; HCW group, 72.5%; P = .77), and pathogens were detected in 93.8% and 77.5% of the specimens, respectively (P = .03).","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Zoch-Lesniak', 'Affiliation': 'Centre of Rehabilitation Research, University of Potsdam, Germany.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Queensland, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Grimwood', 'Affiliation': 'Menzies Health Institute Queensland, Queensland, Australia.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Lambert', 'Affiliation': 'Child Health Research Centre, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piy136']
1165,31679902,"The effect of yoga on respiratory functions, symptom control and life quality of asthma patients: A randomized controlled study.","AIM


This study was conducted to find out the effect of yoga applied to asthma patients on the patients' respiratory functions, symptom control and quality of life.
METHODS


The sample of the study consisted of a total of randomly chosen 112 asthma patients, 56 in the experimental group and 56 in the control group, who met the research criteria and who agreed to participate in the study. A total of 12 yoga sessions, 2 sessions a week for 6 weeks, was applied to the patients in the experimental group. The patients in the control group did not receive any intervention.
RESULTS


In the intragroup comparison of average pre-test and post-test scores of respiratory function and Asthma Control Test (ACT) and Asthma Quality of Life Scale (AQLQ) total and sub-dimension scores of the patients in the experimental and control group, the difference was found to be statistically significant (p < 0.05). In addition, post-test score averages were found to increase in the experimental group, while they were found to decrease in the control group.
CONCLUSION


It was found that yoga influenced respiratory functions, symptom control and quality of life positively in asthma patients. The clinical trial registration number is NCT04107415/https://clinicaltrials.gov/ct2/show/NCT04107415.",2020,"In addition, post-test score averages were found to increase in the experimental group, while they were found to decrease in the control group.
","['asthma patients', 'asthma patients on the patients', '112 asthma patients, 56 in the experimental group and 56 in the control group, who met the research criteria and who agreed to participate in the study']",[],"['respiratory function and Asthma Control Test (ACT) and Asthma Quality of Life Scale (AQLQ) total and sub-dimension scores', 'respiratory functions, symptom control and life quality', 'respiratory functions, symptom control and quality of life']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035168'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0034380'}]",112.0,0.0192302,"In addition, post-test score averages were found to increase in the experimental group, while they were found to decrease in the control group.
","[{'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Bahçecioğlu Turan', 'Affiliation': 'Ataturk University, Faculty of Nursing, Department of Internal Medicine Nursing, Erzurum, Turkey. Electronic address: glcnbah@hotmail.com.'}, {'ForeName': 'Mehtap', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Ataturk University, Faculty of Nursing, Department of Internal Medicine Nursing, Erzurum, Turkey. Electronic address: mtan@atauni.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101070']
1166,30497658,Comparison of ultrasound and extracorporeal shock wave therapy in lateral epicondylosis.,"OBJECTIVE


The aim of this study was to compare the efficacy of extracorporeal shock wave therapy (ESWT) and therapeutic ultrasound (US) in the treatment of lateral epicondylosis (LE).
METHODS


Our study enrolled 50 patients with LE. Patients were randomized into two groups. Group 1 underwent therapeutic US (n = 24; 5 males and 15 females; mean age: 43.75 ± 4.52) Group 2 underwent ESWT (n = 20; 8 males and 16 females; mean age: 46.04 ± 9.24). Patients were evaluated at baseline, after treatment,and 1 month following treatment. The outcome measures were the visual analog scale (VAS), algometer, grip dynamometer, quick-disability of the arm,shoulder,and hand (QDASH), patient-rated tennis elbow evaluation (PRTEE), and Short Form-36 (SF-36) health survey questionnairre.
RESULTS


Both groups showed significant improvements in terms of VAS (all p values < 0.0001), dynamometer (p = 0.001 vs p = 0.015), algometer (all p values < 0.0001), PRTEE (all p values < 0.0001), QDASH (all p values < 0.0001), and SF-36 scores (p = 0.001 vs p = 0.005) within time. There was no significant difference between the two groups, except algometer scores in favor of ESWT (p = 0.029).
CONCLUSION


ESWT and therapeutic US are equally effective in treating LE. ESWT is an alternative therapeutic intervention and as effective as US.
LEVEL OF EVIDENCE


Level III, Therapeutic study.",2018,"Both groups showed significant improvements in terms of VAS (all p values < 0.0001), dynamometer (p = 0.001 vs p = 0.015), algometer (all p values < 0.0001), PRTEE (all p values < 0.0001), QDASH (all p values < 0.0001), and SF-36 scores (p = 0.001 vs p = 0.005) within time.","['n\xa0=\xa020; 8 males and 16 females', '50 patients with LE', '24; 5 males and 15 females; mean age: 43.75\xa0±\xa04.52', 'lateral epicondylosis', 'lateral epicondylosis (LE']","['ultrasound and extracorporeal shock wave therapy', 'extracorporeal shock wave therapy (ESWT) and therapeutic ultrasound (US', 'therapeutic US (n\xa0', 'ESWT']","['QDASH', 'visual analog scale (VAS), algometer, grip dynamometer, quick-disability of the arm,shoulder,and hand (QDASH), patient-rated tennis elbow evaluation (PRTEE), and Short Form-36 (SF-36) health survey questionnairre', 'SF-36 scores', 'VAS']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.0314923,"Both groups showed significant improvements in terms of VAS (all p values < 0.0001), dynamometer (p = 0.001 vs p = 0.015), algometer (all p values < 0.0001), PRTEE (all p values < 0.0001), QDASH (all p values < 0.0001), and SF-36 scores (p = 0.001 vs p = 0.005) within time.","[{'ForeName': 'Bestami', 'Initials': 'B', 'LastName': 'Yalvaç', 'Affiliation': 'Özel Başarı Hospital, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey.'}, {'ForeName': 'Nilgün', 'Initials': 'N', 'LastName': 'Mesci', 'Affiliation': 'Haydarpaşa Numune Education and Research Hospital, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey. Electronic address: nilgunbilgili@yahoo.com.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Geler Külcü', 'Affiliation': 'Haydarpaşa Numune Education and Research Hospital, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey.'}, {'ForeName': 'Ozan Volkan', 'Initials': 'OV', 'LastName': 'Yurdakul', 'Affiliation': 'Bezmialem Vakıf University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.1016/j.aott.2018.06.004']
1167,29261439,Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012.,"Purpose To determine whether cotargeting poly (ADP-ribose) polymerase-1 plus androgen receptor is superior to androgen receptor inhibition in metastatic castration-resistant prostate cancer (mCRPC) and whether ETS fusions predict response. Patients and Methods Patients underwent metastatic site biopsy and were stratified by ETS status and randomly assigned to abiraterone plus prednisone without (arm A) or with veliparib (arm B). Primary objectives were: confirmed prostate-specific antigen (PSA) response rate (RR) and whether ETS fusions predicted response. Secondary objectives were: safety, measurable disease RR (mRR), progression-free survival (PFS), and molecular biomarker analysis. A total of 148 patients were randomly assigned to detect a 20% PSA RR improvement. Results A total of 148 patients with mCRPC were randomly assigned: arm A, n = 72; arm B, n = 76. There were no differences in PSA RR (63.9% v 72.4%; P = .27), mRR (45.0% v 52.2%; P = .51), or median PFS (10.1 v 11 months; P = .99). ETS fusions did not predict response. Exploratory analysis of tumor sequencing (80 patients) revealed: 41 patients (51%) were ETS positive, 20 (25%) had DNA-damage repair defect (DRD), 41 (51%) had AR amplification or copy gain, 34 (43%) had PTEN mutation, 33 (41%) had TP53 mutation, 39 (49%) had PIK3CA pathway activation, and 12 (15%) had WNT pathway alteration. Patients with DRD had significantly higher PSA RR (90% v 56.7%; P = .007) and mRR (87.5% v 38.6%; P = .001), PSA decline ≥ 90% (75% v 25%; P = .001), and longer median PFS (14.5 v 8.1 months; P = .025) versus those with wild-type tumors. Median PFS was longer in patients with normal PTEN (13.5 v 6.7 months; P = .02), TP53 (13.5 v 7.7 months; P = .01), and PIK3CA (13.8 v 8.3 months; P = .03) versus those with mutation or activation. In multivariable analysis adjusting for clinical covariates, DRD association with PFS remained significant. Conclusion Veliparib and ETS status did not affect response. Exploratory analysis identified a novel DRD association with mCRPC outcomes.",2018,"Patients with DRD had significantly higher PSA RR (90% v 56.7%; P = .007) and mRR (87.5% v 38.6%; P = .001), PSA decline ≥ 90% (75% v 25%; P = .001), and longer median PFS (14.5 v 8.1 months; P = .025) versus those with wild-type tumors.","['tumor sequencing (80 patients) revealed: 41 patients (51%) were ETS positive, 20 (25%) had DNA-damage repair defect ', 'Metastatic Castration-Resistant Prostate Cancer', 'Patients and Methods Patients underwent metastatic site biopsy and were stratified by ETS status and randomly assigned to', '148 patients', '148 patients with mCRPC', 'metastatic castration-resistant prostate cancer (mCRPC']","['abiraterone plus prednisone without (arm A) or with veliparib (arm B', 'cotargeting poly (ADP-ribose) polymerase-1 plus androgen receptor']","['PSA RR', 'PIK3CA pathway activation', 'TP53', 'safety, measurable disease RR (mRR), progression-free survival (PFS), and molecular biomarker analysis', 'AR amplification or copy gain', 'confirmed prostate-specific antigen (PSA) response rate (RR) and whether ETS fusions predicted response', 'mRR', 'longer median PFS', 'median PFS', 'Median PFS']","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C4082864', 'cui_str': 'NAD+ ADP-ribosyltransferase-1'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",148.0,0.310998,"Patients with DRD had significantly higher PSA RR (90% v 56.7%; P = .007) and mRR (87.5% v 38.6%; P = .001), PSA decline ≥ 90% (75% v 25%; P = .001), and longer median PFS (14.5 v 8.1 months; P = .025) versus those with wild-type tumors.","[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Daignault-Newton', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Przemyslaw W', 'Initials': 'PW', 'LastName': 'Twardowski', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Costantine', 'Initials': 'C', 'LastName': 'Albany', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Stein', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Lakshmi P', 'Initials': 'LP', 'LastName': 'Kunju', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Siddiqui', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Yi-Mi', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lonigro', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Tomlins', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Cooney', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Montgomery', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Shevrin', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Young E', 'Initials': 'YE', 'LastName': 'Whang', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Smith', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Megan V', 'Initials': 'MV', 'LastName': 'Caram', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Knudsen', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Arul M', 'Initials': 'AM', 'LastName': 'Chinnaiyan', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.75.7310']
1168,30378448,Social conversation skill improvements associated with the Social Tools And Rules for Teens program for adolescents with autism spectrum disorder: Results of a randomized controlled trial.,"There has been a significant increase in the development of interventions to improve the social competence and success of adolescents with autism spectrum disorder. The current investigation used direct observation and coding of social conversations as a rigorous method to further assess the efficacy of the Social Tools And Rules for Teens socialization intervention for adolescents with autism spectrum disorder in the context of a randomized controlled trial. A total of 35 adolescents with high-functioning autism spectrum disorder were randomized to either a treatment or waitlist control group. The 20-week group intervention took place once a week for 90 min per session. Brief video-recorded conversations between participants and unfamiliar, untrained peers were recorded at pre- and post-time points and coded for selected social behaviors (i.e. questions asked, positive facial expressions, and mutual engagement). Results revealed a significant Group × Time treatment effect for both questions asked and positive facial expressions. The findings support that the Social Tools And Rules for Teens intervention can positively impact specific, observable social behaviors through systematic coding of live social conversations within the context of a randomized controlled trial. This investigation is one of the first randomized controlled trials of a group socialization intervention to use systematic coding of live social conversations to assess social competence improvements.",2019,A total of 35 adolescents with high-functioning autism spectrum disorder were randomized to either a treatment or waitlist control group.,"['adolescents with autism spectrum disorder', '35 adolescents with high-functioning autism spectrum disorder']",['waitlist control group'],['positive facial expressions'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}]",35.0,0.0582681,A total of 35 adolescents with high-functioning autism spectrum disorder were randomized to either a treatment or waitlist control group.,"[{'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Ko', 'Affiliation': 'University of California, Santa Barbara, USA.'}, {'ForeName': 'Amber R', 'Initials': 'AR', 'LastName': 'Miller', 'Affiliation': 'University of California, Santa Barbara, USA.'}, {'ForeName': 'Ty W', 'Initials': 'TW', 'LastName': 'Vernon', 'Affiliation': 'University of California, Santa Barbara, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361318808781']
1169,30641025,E-mentoring for youth with physical disabilities preparing for employment: a content analysis of support exchanged between participants of a mentored and non-mentored group.,"Background:  Peer-mentoring is a method of delivering support that may ameliorate some of the challenges that youth with physical disabilities experience when preparing for future employment. This qualitative study compared and described forum content of an employment-focused peer e-mentoring intervention for youth with physical disabilities with a focus on support provided within a mentored group (an experimental group) and a non-mentored group (a control group). Methods:  Using a descriptive qualitative approach, textual data from discussion forums of two groups within a peer e-mentoring intervention were analyzed through a content analysis. This qualitative study was part of a larger mixed - method pilot - randomized control trial on peer e-mentoring. Results:  The mentored group consisted of nine youth with physical disabilities, aged 15-21 (mean age, 17.8) and two paid - peer mentors, and the non-mentored group included seven youth with physical disabilities, aged 15-19 (mean age   =   16.1). We analyzed 151 posts. The types of support exchanged differed between the two groups. Two overarching themes emerged: (1) solution-focused support and (2) catalysts for support Conclusion:  Peer e-mentoring can offer youth unique forms of support to help them prepare for employment. Clinicians may explore the opportunity for peer e-mentoring to complement current practice in preparing youth with physical disabilities for future employment.Implications for rehabilitationClinicians such as social workers, occupational therapists, and life skill coaches who are interested in preparing youth with physical disabilities for employment should consider the unique types of support provided in an online-mentored group.Peer e-mentoring has the potential to offer youth with physical disabilities distinct types of support and addresses concerns raised from face-to-face mentoring programs, such as accessibility and time.",2020,"Peer e-mentoring has the potential to offer youth with physical disabilities distinct types of support and addresses concerns raised from face-to-face mentoring programs, such as accessibility and time.","['youth with physical disabilities preparing for employment', 'nine youth with physical disabilities, aged 15-21 (mean age, 17.8) and two paid-peer mentors, and the non-mentored group included seven youth with physical disabilities, aged 15-19 (mean age\xa0=\xa016.1', 'youth with physical disabilities']","['employment-focused peer e-mentoring intervention', 'solution-focused support and (2) catalysts for support Conclusion: Peer e-mentoring', 'Peer e-mentoring', 'E-mentoring']",[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4319689', 'cui_str': 'Sixteen point one'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}]",[],151.0,0.0282194,"Peer e-mentoring has the potential to offer youth with physical disabilities distinct types of support and addresses concerns raised from face-to-face mentoring programs, such as accessibility and time.","[{'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Cassiani', 'Affiliation': 'Rehabilitation Science Institute, Toronto, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lindsay', 'Affiliation': 'Rehabilitation Science Institute, Toronto, Canada.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1543360']
1170,31662239,Comparing acupressure with aromatherapy using Citrus aurantium in terms of their effectiveness in sleep quality in patients undergoing percutaneous coronary interventions: A randomized clinical trial.,"INTRODUCTION


Poor sleep quality is prevalent in candidates for percutaneous coronary interventions (PCIs). The present study was conducted to compare aromatherapy with acupressure in terms of their effectiveness in sleep quality in patients undergoing PCIs.
MATERIALS AND METHODS


The present study was conducted on 85 patients undergoing PCIs and randomly assigned, using block randomization, to five groups, namely (1)aromatherapy, (2)placebo aromatherapy, (3)acupressure, (4)placebo acupressure (acupressure applied to a point not traditionally associated with improving sleep) and (5)control. The intervention groups received aromatherapy or acupressure or placebo from 10pm to 8am the following day. The control group received only routine care. Sleep quality was measured in the patients using a visual analog scale (VAS) that was completed by them before and after the intervention.
RESULTS


The mean pretest score of sleep quality was 2.91 ± 0.53 in the aromatherapy group, 2.84 ± 0.47 in the placebo aromatherapy group, 2.98 ± 0.59 in the acupressure group, 2.75 ± 0.41 in the placebo acupressure group and 2.88 ± 0.41 in the controls. ANOVA suggested no significant differences among these groups in the pretest (P = 0.746). The mean posttest score of sleep quality was 3.72 ± 1.84 in the aromatherapy group, 3.70 ± 1.83 in the placebo aromatherapy group, 7.35 ± 0.99 in the acupressure group, 2.67 ± 0.41in the placebo acupressure group and 2.72 ± 0.34 in the controls, suggesting significant differences among the five groups based on the ANOVA results showed significant differences among the five groups (P < 0.001). The mean posttest score of sleep quality was higher than the pretest score by 4.37 in the acupressure group compared to in the other groups (P < 0.001).
CONCLUSION


The present findings provided scientific evidence for the benefits of using different methods, including acupressure, for sleep quality in patients undergoing PCIs.
IRANIAN REGISTRY OF CLINICAL TRIALS NUMBER


IRCT201707248665N6.",2020,"The mean posttest score of sleep quality was higher than the pretest score by 4.37 in the acupressure group compared to in the other groups (P < 0.001).
","['patients undergoing percutaneous coronary interventions', 'patients undergoing PCIs', '85 patients undergoing PCIs']","['aromatherapy with acupressure', 'aromatherapy or acupressure or placebo', 'acupressure with aromatherapy', 'namely (1)aromatherapy, (2)placebo aromatherapy, (3)acupressure, (4)placebo acupressure (acupressure applied to a point not traditionally associated with improving sleep) and (5)control', 'routine care']","['Sleep quality', 'sleep quality', 'mean posttest score of sleep quality', 'visual analog scale (VAS', 'mean pretest score of sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",85.0,0.0585768,"The mean posttest score of sleep quality was higher than the pretest score by 4.37 in the acupressure group compared to in the other groups (P < 0.001).
","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Asgari', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: asgari5000@gmail.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Vafaei-Moghadam', 'Affiliation': 'Critical Care Nursing, Student Research Committee, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: ahmadmoghaddam24@gmail.com.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Babamohamadi', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: babamohamadi@semums.ac.ir.'}, {'ForeName': 'Raheb', 'Initials': 'R', 'LastName': 'Ghorbani', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Epidemiology and Statistics, Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: Ghorbani.raheb93@gmail.com.'}, {'ForeName': 'Ravanbakhsh', 'Initials': 'R', 'LastName': 'Esmaeili', 'Affiliation': 'Orthopedic Research Center, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: r.esmaeili@mazums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101066']
1171,30624719,Relationship between body mass index and outcomes in patients with atrial fibrillation treated with edoxaban or warfarin in the ENGAGE AF-TIMI 48 trial.,"AIMS


To investigate the relationship between body mass index (BMI) and outcomes in patients with atrial fibrillation (AF).
METHODS AND RESULTS


In the ENGAGE AF-TIMI 48 trial, patients with AF were randomized to warfarin (international normalized ratio 2.0-3.0) or edoxaban. The cohort (N = 21 028) included patients across BMI categories (kg/m2): underweight (<18.5) in 0.8%, normal (18.5 to <25) in 21.4%, overweight (25 to <30) in 37.6%, moderately obese (30 to <35) in 24.8%, severely obese (35 to <40) in 10.0%, and very severely obese (≥40) in 5.5%. In an adjusted analysis, higher BMI (continuous, per 5 kg/m2 increase) was significantly and independently associated with lower risks of stroke/systemic embolic event (SEE) [hazard ratio (HR) 0.88, P = 0.0001], ischaemic stroke/SEE (HR 0.87, P < 0.0001), and death (HR 0.91, P < 0.0001), but with increased risks of major (HR 1.06, P = 0.025) and major or clinically relevant non-major bleeding (HR 1.05, P = 0.0007). There was a significant interaction between sex and increasing BMI category, with lower risk of ischaemic stroke/SEE in males and increased risk of bleeding in women. Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >18.5 kg/m2, while time in therapeutic range for warfarin improved significantly as BMI increased (P < 0.0001). The effects of edoxaban vs. warfarin on stroke/SEE, major bleeding, and net clinical outcome were similar across BMI groups.
CONCLUSION


An increased BMI was independently associated with a lower risk of stroke/SEE, better survival, but increased risk of bleeding. The efficacy and safety profiles of edoxaban were similar across BMI categories ranging from 18.5 to >40.",2019,Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >,"['The cohort (N\u2009=\u200921\xa0028) included patients across BMI categories (kg/m2): underweight (<18.5) in 0.8%, normal (18.5 to <25) in 21.4%, overweight (25 to <30) in 37.6%, moderately obese (30 to <35) in 24.8%, severely obese (35 to <40) in 10.0%, and very severely obese (≥40) in 5.5', 'patients with atrial fibrillation treated with', 'patients with atrial fibrillation (AF', 'patients with AF']","['edoxaban', 'edoxaban or warfarin', 'warfarin', 'edoxaban vs. warfarin']","['BMI', 'risk of bleeding', 'Trough edoxaban concentration and anti-Factor Xa activity', 'death', 'major or clinically relevant non-major bleeding', 'lower risk of stroke/SEE, better survival', 'stroke/SEE, major bleeding, and net clinical outcome', 'lower risks of stroke/systemic embolic event (SEE', 'ischaemic stroke/SEE']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",,0.116703,Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena & Reggio Emilia, Modena University Hospital, Via del Pozzo 71, Modena, Italy.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi Sankyo, Inc., Global Clinical Development Department, 211 Mount Airy Road, Basking Ridge, NJ, USA.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Global Medical Affairs Department, Zielstattstr. 48, Munich, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Rutman', 'Affiliation': 'Daiichi Sankyo, Inc., Global Clinical Development Department, 211 Mount Airy Road, Basking Ridge, NJ, USA.'}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Daiichi Sankyo, Inc., Global Clinical Development Department, 211 Mount Airy Road, Basking Ridge, NJ, USA.'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}]",European heart journal,['10.1093/eurheartj/ehy861']
1172,30624997,"Physical endometrial manipulation and its impact on success rate and live birth rate in ICSI in patients with unexplained infertility after recurrent ICSI failure, a double blinded randomized controlled trial.","Background:  Unexplained infertility is a rising problem and endometrial manipulation could be one of the solutions for enhancing the pregnancy rate and live birth rate in such circumstances. Aims:  To evaluate the influence of local endometrial physical manipulation with specializd method for endometrial and tubal hydration (Elgazzar and Alalfy technique) on ICSI outcome and in increasing chemical, clinical, and live birth rate in ICSI after previous recurrent ICSI failure in patients with unexplained infertility. Results:  When comparing group 1 (hydrotubation group) and group 2 (the control group with no intervention) with regards to the biochemical, clinical, and live birth rate, the hydrotubation group revealed higher rates and a better ICSI outcome. Conclusion:  Hydrotubation is useful in increasing biochemical, clinical, and live birth rates after recurrent failed ICSI trials with a specialized method for hydration of endometrium and tubes (Elgazzar and Alalfy technique).",2020,"CONCLUSION


Hydrotubation is useful in increasing biochemical, clinical, and live birth rates after recurrent failed ICSI trials with a specialized method for hydration of endometrium and tubes (Elgazzar and Alalfy technique).","['patients with unexplained infertility after recurrent ICSI failure', 'patients with unexplained infertility']","['Physical endometrial manipulation', 'local endometrial physical manipulation with specializd method for endometrial and tubal hydration (Elgazzar and Alalfy technique', 'ICSI']","['pregnancy rate and live birth rate', 'success rate and live birth rate', 'higher rates and a better ICSI outcome', 'live birth rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]",,0.307028,"CONCLUSION


Hydrotubation is useful in increasing biochemical, clinical, and live birth rates after recurrent failed ICSI trials with a specialized method for hydration of endometrium and tubes (Elgazzar and Alalfy technique).","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alalfy', 'Affiliation': 'Reproductive Health and Family Planning Department, National Research Centre, Aljazeerah Hospital, CAIFM, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elgazzar', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nevein', 'Initials': 'N', 'LastName': 'Ghamry', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Elsawah', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Azkalani', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Lithy', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hammam', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Gaafar', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Elshenofy', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Nagy', 'Affiliation': 'Reproductive Health and Family Planning Department, National Research Centre, Aljazeerah Hospital, CAIFM, Cairo, Egypt.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Abdella', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Yossra', 'Initials': 'Y', 'LastName': 'Lasheen', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Soliman', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Wahba', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Haggag', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hany', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Farouk', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Sharaf', 'Affiliation': 'Obstetrics and Gynecology Department, Kasralainy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Alaa Hamed', 'Initials': 'AH', 'LastName': 'Al Arshal', 'Affiliation': 'Obstetrics and Gynecology Department, AlAzhar University, Cairo, Egypt.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1566897']
1173,27579859,Agglutination by anti-capsular polysaccharide antibody is associated with protection against experimental human pneumococcal carriage.,"The ability of pneumococcal conjugate vaccine (PCV) to decrease transmission by blocking the acquisition of colonization has been attributed to herd immunity. We describe the role of mucosal immunoglobulin G (IgG) to capsular polysaccharide (CPS) in mediating protection from carriage, translating our findings from a murine model to humans. We used a flow cytometric assay to quantify antibody-mediated agglutination demonstrating that hyperimmune sera generated against an unencapsulated mutant was poorly agglutinating. Passive immunization with this antiserum was ineffective to block acquisition of colonization compared to agglutinating antisera raised against the encapsulated parent strain. In the human challenge model, samples were collected from PCV and control-vaccinated adults. In PCV-vaccinated subjects, IgG levels to CPS were increased in serum and nasal wash (NW). IgG to the inoculated strain CPS dropped in NW samples after inoculation suggesting its sequestration by colonizing pneumococci. In post-vaccination NW samples pneumococci were heavily agglutinated compared with pre-vaccination samples in subjects protected against carriage. Our results indicate that pneumococcal agglutination mediated by CPS-specific antibodies is a key mechanism of protection against acquisition of carriage. Capsule may be the only vaccine target that can elicit strong agglutinating antibody responses, leading to protection against carriage acquisition and generation of herd immunity.",2017,Passive immunization with this antiserum was ineffective to block acquisition of colonization compared to agglutinating antisera raised against the encapsulated parent strain.,[],"['pneumococcal conjugate vaccine (PCV', 'mucosal immunoglobulin G (IgG) to capsular polysaccharide (CPS']",['IgG levels to CPS'],[],"[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement (procedure)'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0294526,Passive immunization with this antiserum was ineffective to block acquisition of colonization compared to agglutinating antisera raised against the encapsulated parent strain.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mitsi', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Roche', 'Affiliation': 'Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reiné', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zangari', 'Affiliation': 'Department of Microbiology, New York University School of Medicine, New York, NY 10016, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Owugha', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Pennington', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Gritzfeld', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Wright', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Selm', 'Affiliation': 'Department of Pediatrics, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'de Jonge', 'Affiliation': 'Department of Pediatrics, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Weiser', 'Affiliation': 'Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",Mucosal immunology,['10.1038/mi.2016.71']
1174,30601581,Reduction of Cortical Bone Turnover and Erosion Depth After 2 and 3 Years of Denosumab: Iliac Bone Histomorphometry in the FREEDOM Trial.,"Denosumab, a RANKL inhibitor, reduced the risk of vertebral, hip, and nonvertebral fractures in the Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) trial of postmenopausal women with osteoporosis compared with placebo. Previous bone histomorphometric analysis in FREEDOM showed decreased bone resorption and turnover in cancellous bone after 2 and 3 years. The purpose of the present study was to evaluate the effects of denosumab compared with placebo in the cortical compartment from transiliac bone biopsies obtained during FREEDOM. A total of 112 specimens were evaluable for cortical histomorphometry, including 67 obtained at month 24 (37 placebo, 30 denosumab) and 45 at month 36 (25 placebo, 20 denosumab). Eroded surface, osteoclast surface, erosion depth, and wall thickness were measured on the endocortical surface. Cortical thickness and cortical porosity were also measured. Dynamic parameters of bone formation were assessed for endocortical, periosteal, and intracortical envelopes. Endocortical osteoclast surface, eroded surface, and mean and maximum erosion depth were significantly lower in the denosumab group versus placebo at months 24 and 36 (p < 0.0001 to p = 0.04). Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness) were not different between the two groups. Dynamic parameters were low with tetracycline labels in cortical bone observed in 13 (43%) and 10 (50%) of denosumab biopsies at months 24 and 36, respectively, reflecting a marked decrease in bone turnover. In conclusion, our data reveal the mechanism of action of denosumab on cortical bone: inhibition of osteoclastic resorption and reduced activation of new remodeling sites. In addition, reduced endocortical erosion depth with no change of wall thickness may contribute to increased bone strength by reducing the bone loss and fragility associated with deep resorption cavities and may likely contribute to the greater BMD gain with denosumab than with other antiresorptive agents. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.",2019,Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness) were not different between the two groups.,"['A total of 112 specimens were evaluable for cortical histomorphometry, including 67 obtained at month 24 (37 placebo, 30 denosumab) and 45 at month 36 (25 placebo, 20 denosumab', 'postmenopausal women with osteoporosis']","['Denosumab', 'placebo', 'tetracycline labels', 'denosumab', 'Denosumab: Iliac Bone Histomorphometry']","['cortical bone', 'Cortical Bone Turnover and Erosion Depth', 'bone strength', 'Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness', 'bone formation', 'BMD gain', 'Cortical thickness and cortical porosity', 'bone turnover', 'Endocortical osteoclast surface, eroded surface, and mean and maximum erosion depth', 'Eroded surface, osteoclast surface, erosion depth, and wall thickness', 'bone resorption and turnover in cancellous bone']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039651', 'cui_str': 'Tetracyclines'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}]","[{'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0080037', 'cui_str': 'Porosity'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0029431', 'cui_str': 'Osteoclasts'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}]",112.0,0.0419879,Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness) were not different between the two groups.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Chavassieux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Portero-Muzy', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Jean Paul', 'Initials': 'JP', 'LastName': 'Roux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Horlait', 'Affiliation': 'Amgen, Boulogne Billancourt, France.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Department of Pathology and Cell Biology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Chapurlat', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3631']
1175,31676298,Evaluation of meaning of life and self-care agency in nursing care given to chronic obstructive pulmonary patients according to health promotion model.,"The study was conducted to evaluate the meaning of life and self-care agency in nursing care given to chronic obstructive pulmonary patients according to the health promotion model. The sample of the study was determined by power analysis and 40 COPD patients were assigned to each group by simple random sampling method. Descriptive Information Form, Life Attitude Profile and Self-care Agency Scale were used to obtain the data. Nursing care was applied by the researcher 3 times in every 2 weeks according to the health promotion model in the houses of the patients in the experimental groups. Number, percentage, mean, standard deviation, dependent samples t-test, independent samples t-test, chi-square and ANOVA were used to analyze the data. It was determined that while posttest mean score of the patients in the Experimental group 1 for Self-care agency scale was 112.70 ± 29.0; their posttest mean score for Life Attitude Profile was 156.37 ± 13.5. Posttest mean score of the patients in the Control group 1 for Self-care agency scale was 81.35 ± 17.7; whereas, their posttest mean score for Life Attitude Profile was 120.50 ± 31.9. The difference between the posttest mean scores of the groups was statistically significant (p < 0.05). The care applied to the patients with COPD according to health promotion model was found to increase self-care agency and meaning of life of the patients.",2020,The care applied to the patients with COPD according to health promotion model was found to increase self-care agency and meaning of life of the patients.,"['chronic obstructive pulmonary patients according to the health promotion model', '40 COPD patients', 'chronic obstructive pulmonary patients according to health promotion model']",[],"['Self-care agency scale', 'Life Attitude Profile and Self-care Agency Scale', 'meaning of life and self-care agency']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]",[],"[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0222045'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",40.0,0.0119538,The care applied to the patients with COPD according to health promotion model was found to increase self-care agency and meaning of life of the patients.,"[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Karasu', 'Affiliation': 'Kilis 7 Aralık University, Yusuf Şerefoğlu Faculty of Health Sciences, Department of Nursing, Kilis, Turkey. Electronic address: fatmakarasu@kilis.edu.tr.'}, {'ForeName': 'Rukuye', 'Initials': 'R', 'LastName': 'Aylaz', 'Affiliation': 'Inönü University, Faculty of Nursing, Malatya, Turkey. Electronic address: rukuye.aylaz@inonu.edu.tr.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151208']
1176,25364994,Patient perspectives on buprenorphine/naloxone: a qualitative study of retention during the starting treatment with agonist replacement therapies (START) study.,"This study examines the barriers and facilitators of retention among patients receiving buprenorphine/naloxone at eight community-based opioid treatment programs across the United States. Participants (n = 105) were recruited up to three and a half years after having participated in a randomized clinical trial comparing the effect of buprenorphine/naloxone and methadone on liver function. Semi-structured interviews were conducted with 67 patients provided with buprenorphine/naloxone who had terminated early and 38 patients who had completed at least 24 weeks of the trial. Qualitative data were analyzed using the constant comparison method. Barriers to buprenorphine/naloxone retention that emerged included factors associated with: (1) the design of the clinical trial; (2) negative medication or treatment experience; and (3) personal circumstances. The facilitators comprised: (1) positive experience with the medication; (2) personal determination and commitment to complete; and (3) staff encouragement and support. The themes drawn from interviews highlight the importance of considering patients' prior experience with buprenorphine/naloxone and methadone, medication preference, personal circumstances, and motivation to abstain from illicit use or misuse of opioids, as these may influence retention. Ongoing education of patients and staff regarding buprenorphine/naloxone, especially in comparison to methadone, and support from staff and peers are essential.",2014,Semi-structured interviews were conducted with 67 patients provided with buprenorphine/naloxone who had terminated early and 38 patients who had completed at least 24 weeks of the trial.,"['at eight community-based opioid treatment programs across the United States', 'Participants (n = 105) were recruited up to three and a half years after having participated', 'who had terminated early and 38 patients who had completed at least 24 weeks of the trial', 'patients receiving']","['buprenorphine/naloxone and methadone', 'buprenorphine/naloxone']",['liver function'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}]",105.0,0.0232863,Semi-structured interviews were conducted with 67 patients provided with buprenorphine/naloxone who had terminated early and 38 patients who had completed at least 24 weeks of the trial.,"[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Teruya', 'Affiliation': 'a Investigator, UCLA Integrated Substance Abuse Programs , Los Angeles , CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'Shannon Gwin', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Hasson', 'Affiliation': ''}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Samantha H', 'Initials': 'SH', 'LastName': 'Buoncristiani', 'Affiliation': ''}, {'ForeName': 'Yih-Ing', 'Initials': 'YI', 'LastName': 'Hser', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': ''}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Glick', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McLaughlin', 'Affiliation': ''}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': ''}]",Journal of psychoactive drugs,['10.1080/02791072.2014.921743']
1177,31593697,Oxytocin amplifies the influence of good intentions on social judgments.,"Studies have shown that the evolutionarily conserved neuropeptide oxytocin (OT) promotes various prosocial behaviors, yet there are few studies of the effect of OT on social judgments, especially on judgments when the actor's intention and the final outcome are incongruent. In a double-blind, placebo-controlled experiment, participants were asked to play the role of the recipient in a dictator game and to make social judgments about the dictator after intranasal OT administration. To isolate the outcome and the intention of the dictator's allocation, we developed a novel social judgment task in which recipients were told that 50% of the dictators' proposals would be reversed. The results showed that the effect of OT on social judgment was modulated by intention: OT increased goodness ratings only towards dictators with hyperfair intention. Our findings support the affiliative-motivation theory which states that OT enhances the affiliative motivation and recognition of positive-valence social stimuli.",2020,The results showed that the effect of OT on social judgment was modulated by intention: OT increased goodness ratings only towards dictators with hyperfair intention.,[],"['placebo', 'OT', 'neuropeptide oxytocin (OT', 'Oxytocin']","['social judgments', 'goodness ratings', 'affiliative motivation and recognition of positive-valence social stimuli']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0469941,The results showed that the effect of OT on social judgment was modulated by intention: OT increased goodness ratings only towards dictators with hyperfair intention.,"[{'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of Psychology, Center for Studies of Psychological Application and Key Laboratory of Mental Health and Cognitive Science of Guangdong Province, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Chengyan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Center for Studies of Psychological Application and Key Laboratory of Mental Health and Cognitive Science of Guangdong Province, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Rongjun', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore. Electronic address: psyyr@nus.edu.sg.'}]",Hormones and behavior,['10.1016/j.yhbeh.2019.104589']
1178,30613868,Clinical utility of bone turnover markers in monitoring the withdrawal of treatment with oral bisphosphonates in postmenopausal osteoporosis.,"Bone markers may be useful to monitor response to treatment withdrawal in osteoporosis. We used two criteria for investigating the change in BTMs after withdrawal of bisphosphonate treatment. A larger increase in BTMs was associated with greater bone loss. Bone markers may be useful in monitoring of patients taking a pause from treatment.
INTRODUCTION


Measurement of bone turnover markers (BTMs) may be useful to monitor offset of treatment with bisphosphonates (BP) in osteoporosis. We assessed the effect of withdrawal of BP treatment by comparing the changes in BTMs and total hip (TH) bone density (BMD).
METHODS


We studied postmenopausal osteoporotic women who had completed a randomised study of three oral BPs. After 2 years of treatment, participants with BMD T-score > - 2.5 and in whom it was considered clinically appropriate to discontinue treatment, were invited to participate in a further 2-year observational study. Biochemical response was assessed using BTMs (CTX and PINP) with offset being defined by two criteria: (1) an increase greater than the least significant change (LSC) and (2) an increase above the reference mean value.
RESULTS


Fifty women completed the study. At 48 weeks after stopping BPs, CTX was greater than the LSC for 66% of women and PINP 72%; CTX was above the reference mean for 64% of women and PINP 42%. The decrease in THBMD was greater for women with the largest increase in BTM compared to those with continued suppression (mean difference for CTX was - 2.98%, 95%CI - 4.75 to - 1.22, P < 0.001, PINP - 2.25%, 95% CI - 4.46 to - 0.032, P = 0.046).
CONCLUSION


The measurement of BTM after withdrawal of BPs is potentially useful to evaluate patients that are taking a pause from treatment. An increase in BTMs more than the LSC and/or reference mean reflects loss of treatment effect and identifies patients that are likely to have a decrease in BMD. Such changes could provide an indication for reintroduction of treatment.",2019,"At 48 weeks after stopping BPs, CTX was greater than the LSC for 66% of women and PINP 72%; CTX was above the reference mean for 64% of women and PINP 42%.","['Fifty women completed the study', 'postmenopausal osteoporotic women who had completed a randomised study of three oral BPs', 'postmenopausal osteoporosis']","['oral bisphosphonates', 'bisphosphonates (BP']","['BTMs (CTX and PINP', 'THBMD', 'BMD', 'BTMs and total hip (TH) bone density (BMD', 'BTMs', 'BTM', 'Biochemical response']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}]",50.0,0.0815825,"At 48 weeks after stopping BPs, CTX was greater than the LSC for 66% of women and PINP 72%; CTX was above the reference mean for 64% of women and PINP 42%.","[{'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Naylor', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK. k.e.naylor@sheffield.ac.uk.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'McCloskey', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Jacques', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'N F A', 'Initials': 'NFA', 'LastName': 'Peel', 'Affiliation': 'Metabolic Bone Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital Sheffield, Sheffield, UK.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Paggiosi', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gossiel', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Walsh', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-018-04823-5']
1179,31668556,Continue or stop applying wet cupping therapy (al-hijamah) in migraine headache:A randomized controlled trial.,"BACKGROUND


and purpose: Although wet cupping therapy (WCT) is currently in use, clinical investigations of its efficiency are scarce. The aim of this study was to evaluate the short- and long-term effects of WCT on headache and disability associated with migraine.
MATERIALS AND METHODS


This was an open-label trial conducted at Karabuk University Training and Research Hospital between May 2016 and January 2018. WCT was applied once a month to migraine patients. At the end of 3 months, patients were randomized into two groups using block randomization method. Control group (Group 1) consisted of 53 patients and the intervention group (Group 2) 56 patients. Evaluation was performed to both groups before treatment and at the 6th and 12th months using the migraine disability assessment (MIDAS).
RESULTS


Group 1 received three sessions, whereas Group 2 continued treatment for 12 months. Visual analog scale (VAS) and MIDAS values at the 12th month were significantly higher compared with 6-month values in Group 1 (p < 0.001) and lower in Group 2 (p < 0.001). Both VAS and MIDAS scores of the patients in Group 2 improved significantly better than those in Group 1. No adverse effects were seen.
CONCLUSION


WCT reduced pain and disability in patients with migraine, and the efficacy increased when the application was continued.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03503903.",2020,"No adverse effects were seen.
","['Karabuk University Training and Research Hospital between May 2016 and January 2018', 'migraine headache', 'patients with migraine']","['Continue or stop applying wet cupping therapy (al-hijamah', 'WCT', 'wet cupping therapy (WCT']","['pain and disability', 'migraine disability assessment (MIDAS', 'VAS and MIDAS scores', 'headache and disability', 'Visual analog scale (VAS) and MIDAS values', 'adverse effects']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0035168'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0394663', 'cui_str': 'Cupping (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",56.0,0.0441142,"No adverse effects were seen.
","[{'ForeName': 'Suleyman', 'Initials': 'S', 'LastName': 'Ersoy', 'Affiliation': 'Karabuk University, Medical Faculty, Department of Family Medicine, Karabuk, Turkey. Electronic address: suleymanersoy@gmail.com.'}, {'ForeName': 'Ali Ramazan', 'Initials': 'AR', 'LastName': 'Benli', 'Affiliation': 'Karabuk University, Medical Faculty, Department of Family Medicine, Karabuk, Turkey. Electronic address: dralibenli@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101065']
1180,30590425,"Clinical outcomes, edoxaban concentration, and anti-factor Xa activity of Asian patients with atrial fibrillation compared with non-Asians in the ENGAGE AF-TIMI 48 trial.","AIMS


Prior studies suggested that the risks of ischaemic stroke and bleeding in patients of Asian race with atrial fibrillation (AF) may be higher than that of non-Asians. In the analysis of ENGAGE AF-TIMI 48 trial, we compared clinical outcomes, edoxaban concentration, and anti-factor Xa (anti-FXa) activity, between Asian and non-Asian races.
METHODS AND RESULTS


There were 2909 patients of Asian race and 18 195 non-Asian race in the ENGAGE AF-TIMI 48 trial. The risks of thromboembolism and bleeding events were compared for Asians and non-Asians treated with warfarin. The trough levels of edoxaban concentration and anti-FXa activity were also compared and correlated with the efficacy and safety of edoxaban vs. warfarin. Compared to non-Asian patients, the Asian population was on average 2 years younger and 20 kg lighter. In the warfarin group, the adjusted risk of ischaemic stroke did not differ significantly for patients of Asian and non-Asian race [adjusted hazard ratio (aHR) = 1.12, P = 0.56). Asians treated with warfarin had a higher-adjusted risk of intracranial haemorrhage (ICH: aHR 1.71, P = 0.03) compared with non-Asians. The trough edoxaban concentration and anti-FXa activity were 20-25% lower for Asians compared with non-Asians. Compared to warfarin, higher dose edoxaban significantly reduced ICH while preserving the efficacy of stroke prevention in both Asians and non-Asians. Two of three net clinical outcomes appeared to be more favourably reduced with edoxaban in Asians compared with non-Asians (Pint = 0.063 for primary, 0.037 for secondary, and 0.032 for third net clinical outcomes, respectively).
CONCLUSION


Compared to warfarin, higher dose edoxaban preserved the efficacy for stroke prevention and was associated with a favourable safety profile for Asians, which may be due to the lower trough edoxaban concentration and anti-FXa activity achieved in patients of Asian race.",2019,"Compared to warfarin, higher dose edoxaban preserved the efficacy for stroke prevention and was associated with a favourable safety profile for Asians, which may be due to the lower trough edoxaban concentration and anti-FXa activity achieved in patients of Asian race.","['Asian patients with atrial fibrillation', 'patients of Asian race with atrial fibrillation (AF', '2909 patients of Asian race and 18\u2009195 non-Asian race in the ENGAGE AF-TIMI 48 trial']","['edoxaban', 'warfarin', 'edoxaban vs. warfarin']","['adjusted risk of ischaemic stroke', 'risks of thromboembolism and bleeding events', 'clinical outcomes, edoxaban concentration, and anti-factor Xa (anti-FXa) activity', 'trough levels of edoxaban concentration and anti-FXa activity', 'trough edoxaban concentration and anti-FXa activity', 'intracranial haemorrhage', 'efficacy and safety', 'ICH']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0519727,"Compared to warfarin, higher dose edoxaban preserved the efficacy for stroke prevention and was associated with a favourable safety profile for Asians, which may be due to the lower trough edoxaban concentration and anti-FXa activity achieved in patients of Asian race.","[{'ForeName': 'Tze-Fan', 'Initials': 'TF', 'LastName': 'Chao', 'Affiliation': 'Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City 112, Taiwan.'}, {'ForeName': 'Shih-Ann', 'Initials': 'SA', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City 112, Taiwan.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Hamershock', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Cardiovascular, Metabolic and Renal Disease Therapeutic Area, Global Clinical Development, Daiichi Sankyo Pharma Development, 211 Mt. Airy Road, Basking Ridge, NJ USA.'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}]",European heart journal,['10.1093/eurheartj/ehy807']
1181,31673708,A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases: Clinical Trial Protocol.,"BACKGROUND


Brain metastases which require resection are treated with surgery followed by whole brain radiation therapy or postoperative cavity boost stereotactic radiosurgery (POCBS). Recently a novel strategy using neoadjuvant stereotactic radiosurgery (NaSRS) followed by resection was reported, demonstrating lower rates of postoperative leptomeningeal dissemination (LMD) and symptomatic radiation toxicity compared to a comparative cohort of patients treated with postoperative SRS.
OBJECTIVE


To determine if the rate of symptomatic radiation toxicity at 1 yr in patients who receive NaSRS differs significantly from historical rates for patients treated with POCBS.
METHODS


This is a multi-center, non-randomized, open phase II clinical trial. A total of 30 patients with up to 10 brain metastases, at least 1 of which is appropriate for surgical resection, will be enrolled for over 4 yr. All enrolled patients will be assigned to receive NaSRS followed by surgery.
EXPECTED OUTCOME


This study will clarify whether symptomatic radiation toxicity caused by NaSRS is significantly decreased compared to historical rates associated with POCBS. Secondary endpoints will include 1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival. Tertiary analyses will include correlation between LC and radiation toxicity with pretreatment clinical factors, serum markers, radiomic features, and molecular assessments of the resected tumors.
DISCUSSION


This prospective study will determine the toxicity associated with NaSRS and provide additional quantitative metrics of efficacy for future comparative trials.",2020,"Secondary endpoints will include 1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival.","['30 patients with up to 10 brain metastases, at least 1 of which is appropriate for surgical resection, will be enrolled for over 4 yr', 'Large Brain Metastases', 'patients who receive NaSRS differs significantly from historical rates for patients treated with POCBS']","['neoadjuvant stereotactic radiosurgery (NaSRS', 'surgery followed by whole brain radiation therapy or postoperative cavity boost stereotactic radiosurgery (POCBS', 'NaSRS followed by surgery', 'Neoadjuvant Stereotactic Radiosurgery']","['postoperative leptomeningeal dissemination (LMD) and symptomatic radiation toxicity', '1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival', 'rate of symptomatic radiation toxicity', 'LC and radiation toxicity with pretreatment clinical factors, serum markers, radiomic features, and molecular assessments of the resected tumors', 'symptomatic radiation toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0011793', 'cui_str': 'Dextran 40'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",,0.0605815,"Secondary endpoints will include 1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival.","[{'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takami', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Nassiri', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Moraes', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Zadeh', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Conrad', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Berlin', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Normand', 'Initials': 'N', 'LastName': 'Laperriere', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Barbara-Ann', 'Initials': 'BA', 'LastName': 'Millar', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'David Benjamin', 'Initials': 'DB', 'LastName': 'Shultz', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kongkham', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}]",Neurosurgery,['10.1093/neuros/nyz442']
1182,31674219,Are self-efficacy measures confounded with motivation? An experimental test.,"Standard measures of self-efficacy (SE) may confound  perceived capability  and  motivation  because respondents interpret the word ""can"" as ""will"".  Objective:  To test whether priming for the meaning of the word ""can"" changes self-efficacy ratings.  Design:  In an experimental test, 134 university students responded to an on-line standardized measure of exercise SE and provided definitions of the words ""can"" and ""will"". One month later participants were randomized to complete (a) the same questionnaire (control), (b) the same questionnaire but with presentation of each participant's definition of ""can"" prior to the SE measure (definition priming), or (c) the same questionnaire but with SE items (""I can exercise…"") placed side-by-side with behavioral intention items (""I will exercise…"") (side-by-side priming).  Results:  SE increased relative to controls for side-by-side (b = 12.08,  SE  = 2.70,  p <.01) but not definition priming (ns), with the former even stronger among participants ( n  = 91) who provided strict (i.e., literal) rather than liberal definitions of ""can"" (b = 15.38,  SE  = 3.21,  p <.001).  Conclusion:  Priming of the meaning of the word ""can"" led to increases in self-efficacy ratings among those who hold a literal meaning of the word ""can"". This suggests that for many respondents standard assessments of SE may be confounded by motivation.",2020,"increased relative to controls for side-by-side (b = 12.08,  SE  = 2.70,  p <.01) but not definition priming (ns), with the former even stronger among participants ( n  = 91) who provided strict (i.e., literal) rather than liberal definitions of ""can"" (b = 15.38,  SE  = 3.21,  p <.001).  ",['134 university students'],"['can"" prior to the SE measure (definition priming), or (c) the same questionnaire but with SE items (""I can exercise…"") placed side-by-side with behavioral intention items (""I will exercise…', 'SE']",['self-efficacy ratings'],"[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",134.0,0.0141905,"increased relative to controls for side-by-side (b = 12.08,  SE  = 2.70,  p <.01) but not definition priming (ns), with the former even stronger among participants ( n  = 91) who provided strict (i.e., literal) rather than liberal definitions of ""can"" (b = 15.38,  SE  = 3.21,  p <.001).  ","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dionne', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory, School of Exercise Science, Physical and Health Education, University of Victoria, Victoria, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}]",Psychology & health,['10.1080/08870446.2019.1683179']
1183,31672469,Impact of orally administered tramadol combined with self-selected music on adult outpatients with burns undergoing dressing change: A randomized controlled trial.,"OBJECTIVE


To investigate the effects of music and/or tramadol on pain and anxiety in burn outpatients undergoing dressing changes.
DESIGN


Randomized controlled trial.
SETTING


Burns and Plastic Reconstruction Unit.
PARTICIPANTS


Patients (N=180) with burns on up to 10%-30% of the total body surface area (TBSA).
INTERVENTIONS


The patients were randomly allocated to 4 equal-sized groups as follows: (1) tramadol group (TG), patients received 100mg of tramadol orally 20min before the dressing change; (2) music group (MG), patients listened to self-selected music during the dressing change; (3) music-plus-tramadol group (MTG), patients received tramadol and listened to self-selected music; and (4) control group (CG), patients received a routine dressing change only. All patients underwent the interventions once per day for 2days.
MAIN OUTCOME MEASURES


McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes).
RESULTS


The results showed that music-plus-tramadol group (MTG) had better outcomes with respect to pain and anxiety management during dressing changes.
CONCLUSIONS


In comparison with music or tramadol alone, the integration of music and tramadol offers a secure and favorable treatment choice to relieve pain and anxiety, ultimately improving the satisfaction levels of burn outpatients during dressing changes.",2020,"The results showed that music-plus-tramadol group (MTG) had better outcomes with respect to pain and anxiety management during dressing changes.
","['Patients (N=180) with burns on up to 10%-30% of the total body surface area (TBSA', 'Burns and Plastic Reconstruction Unit', 'burn outpatients undergoing dressing changes', 'adult outpatients with burns undergoing dressing change']","['tramadol and listened to self-selected music; and (4) control group (CG', 'tramadol', 'music-plus-tramadol', 'tramadol orally 20min before the dressing change; (2) music group (MG), patients listened to self-selected music during the dressing change; (3) music-plus-tramadol group (MTG', 'tramadol combined with self-selected music', 'routine dressing change only', 'tramadol group (TG', 'music and/or tramadol']","['pain and anxiety management', 'pain and anxiety', 'McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0222045'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.152371,"The results showed that music-plus-tramadol group (MTG) had better outcomes with respect to pain and anxiety management during dressing changes.
","[{'ForeName': 'Xiu-Hang', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: Suhanvip@yeah.net.'}, {'ForeName': 'Xin-Xin', 'Initials': 'XX', 'LastName': 'Gao', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: 891397174@qq.com.'}, {'ForeName': 'Wei-Wei', 'Initials': 'WW', 'LastName': 'Wu', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: zxh012210@163.com.'}, {'ForeName': 'Jia-Ao', 'Initials': 'JA', 'LastName': 'Yu', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: yujiaoao1973@126.com.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.10.010']
1184,31673858,"Incidence of postoperative pain after canal shaping by using Reciproc and Twisted File Adaptive systems: a prospective, randomized clinical trial.","OBJECTIVES


The aim of this prospective clinical trial was to investigate the incidence of postoperative pain after initial root canal treatment using Twisted File Adaptive (TFA) and Reciproc systems.
MATERIALS AND METHODS


A total of sixty-four previously initiated or necrotic posterior teeth were randomly assigned to two groups based on the rotary system used; TFA (SybronEndo, Orange, Ca) (n = 35) and Reciproc (VDW, Munich, Germany) (n = 29). All teeth were treated in a single visit. Patients were contacted to assess the level of postoperative pain on a visual analog scale after treatment by 6 h, 24 h, 48 h, 72 h, and 1 week. Patients were also asked to report if any medication was taken during the follow-up period. The postoperative pain scores were analyzed by Mann-Whitney test with respect to follow-up interval at a significance level of 0.05.
RESULTS


Patients treated with TFA reported significantly lower postoperative pain levels at 24 h, 48 h, and 72 h compared with those in Reciproc group (p < 0.01). There were no significant differences between the two groups at 6 h and 1-week follow-up intervals (p > 0.05). About 11% (TFA) and 24% (Reciproc) of the treated patients took analgesics, but none of them took antibiotics during the follow-up period.
CONCLUSIONS


The tested rotary systems induced postoperative pain after root canal treatment. The TFA system was found to induce less pain scores compared with the Reciproc system after the treatment by 24 h, 48 h, and 72 h.
CLINICAL RELEVANCE


The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.",2020,The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.,['A total of sixty-four previously initiated or necrotic posterior teeth'],"['initial root canal treatment using Twisted File Adaptive (TFA) and Reciproc systems', 'rotary system used; TFA (SybronEndo, Orange, Ca) (n = 35) and Reciproc (VDW, Munich, Germany', 'canal shaping by using Reciproc and Twisted File Adaptive systems', 'TFA']","['postoperative pain', 'pain scores', 'postoperative pain scores', 'level of postoperative pain on a visual analog scale', 'level of postoperative pain', 'postoperative pain levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",64.0,0.0357202,The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.,"[{'ForeName': 'Taher', 'Initials': 'T', 'LastName': 'AlOmari', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Ghadah', 'Initials': 'G', 'LastName': 'AlThobiti', 'Affiliation': 'Specialized Dental Center, Department of Endodontics, Ministry of Health, Taif, Saudi Arabia.'}, {'ForeName': 'Sabri', 'Initials': 'S', 'LastName': 'AlThobaiti', 'Affiliation': 'King Abdulaziz Medical City, Ministry of National Guard-Health Affairs, Jeddah, Saudi Arabia.'}, {'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'AlOufi', 'Affiliation': 'Department of Endodontics, Dental Specialist Center, King Fahad Hospital, Ministry of Health, Medina, Saudi Arabia.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Masuadi', 'Affiliation': 'Department of Medical Education, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Jamleh', 'Affiliation': 'Department of Medical Education, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. aojamleh@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-019-03106-5']
1185,30157940,"Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial.","BACKGROUND


There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) trial.
METHODS


PATH-2 is a pragmatic, parallel-group, multi-centre, double-blinded, randomised, placebo-controlled, superiority trial. The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function. Patients are identified in the orthopaedic/trauma outpatient clinic. The primary outcome is muscle-tendon work capacity from the Heel Rise Endurance Test result, expressed as the Limb Symmetry Index (work, in joules), at 24 weeks post randomisation. Multivariate linear regression adjusting for the stratification factors (centre and age) and additional prognostic factors will be used to investigate the adjusted effect of the intervention. The analysis will be by modified intention-to-treat. Sensitivity analysis will assess the internal validity of the trial results by performing a per-protocol analysis. Safety will be summarised by treatment arm for all patients who started treatment. Secondary patient-reported outcome measures will be analysed using linear mixed effects models to allow all data collected at all follow-up points to be considered. Missing data will be summarised and reported by treatment arm. Missing data imputation will be performed, if appropriate.
DISCUSSION


The PATH-2 trial will be reported in accordance with the CONSORT statement. This SAP publication will avoid bias arising from prior knowledge of the study results. Any changes or deviations from the current SAP will be described and justified in the final report.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN54992179 , assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.",2018,The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function.,[],"['PRP', 'placebo', 'Platelet-rich plasma']","['muscle-tendon work capacity from the Heel Rise Endurance Test result, expressed as the Limb Symmetry Index (work, in joules']",[],"[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439256', 'cui_str': 'Joule'}]",,0.577323,The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function.,"[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Schlüssel', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Kadoorie Centre for Critical Care Research, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wagland', 'Affiliation': 'Kadoorie Centre for Critical Care Research, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Alsousou', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Willett', 'Affiliation': 'Kadoorie Centre for Critical Care Research, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. susan.dutton@csm.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-018-2840-z']
1186,31606362,Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.,"OBJECTIVES


This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.
BACKGROUND


Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.
METHODS


The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.
RESULTS


Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02).
CONCLUSIONS


Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).",2019,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","['20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial ', 'trial randomized patients hospitalized for HF to receive', '79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n\xa0=\xa037,883 [77.2%]; black, n\xa0=\xa011,180 [22.8', 'Decompensated Heart\xa0Failure', 'Decompensated Heart Failure', 'non-Hispanic white (n\xa0=\xa01,494) and black (n\xa0=\xa01,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e.,\xa0Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria', 'from May 2007 to August 2010 and was neutral for clinical endpoints']","['nesiritide or placebo', 'Nesiritide']","['30-day readmission', 'blood pressure and higher ejection fraction', 'mortality rates', 'hospital mortality']","[{'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.20658,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina. Electronic address: stephen.greene@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Forge, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Stanford University, Stanford, California; Verily Life Sciences (Alphabet), South San Francisco, California.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Matsouaka', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Samman Tahhan', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Clyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.07.011']
1187,31424550,Genomic investigation of Staphylococcus aureus recovered from Gambian women and newborns following an oral dose of intra-partum azithromycin.,"BACKGROUND


Oral azithromycin given during labour reduces carriage of bacteria responsible for neonatal sepsis, including Staphylococcus aureus. However, there is concern that this may promote drug resistance.
OBJECTIVES


Here, we combine genomic and epidemiological data on S. aureus isolated from mothers and babies in a randomized intra-partum azithromycin trial (PregnAnZI) to describe bacterial population dynamics and resistance mechanisms.
METHODS


Participants from both arms of the trial, who carried S. aureus in day 3 and day 28 samples post-intervention, were included. Sixty-six S. aureus isolates (from 7 mothers and 10 babies) underwent comparative genome analyses and the data were then combined with epidemiological data. Trial registration (main trial): ClinicalTrials.gov Identifier NCT01800942.
RESULTS


Seven S. aureus STs were identified, with ST5 dominant (n = 40, 61.0%), followed by ST15 (n = 11, 17.0%). ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022). In azithromycin-resistant isolates, msr(A) was the main macrolide resistance gene (n = 36, 80%). Ten study participants, from both trial arms, acquired azithromycin-resistant S. aureus after initially harbouring a susceptible isolate. In nine (90%) of these cases, the acquired clone was an msr(A)-containing ST5 S. aureus. Long-read sequencing demonstrated that in ST5, msr(A) was found on an MDR plasmid.
CONCLUSIONS


Our data reveal in this Gambian population the presence of a dominant clone of S. aureus harbouring plasmid-encoded azithromycin resistance, which was acquired by participants in both arms of the study. Understanding these resistance dynamics is crucial to defining the public health drug resistance impacts of azithromycin prophylaxis given during labour in Africa.",2019,"ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022).","['Participants from both arms of the trial, who carried S. aureus in day 3 and day 28 samples post-intervention, were included', 'Sixty-six S. aureus isolates (from 7 mothers and 10 babies', 'resistant S. aureus after initially harbouring a susceptible isolate']","['placebo', 'azithromycin', 'azithromycin prophylaxis']",[],"[{'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]",[],10.0,0.421266,"ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022).","[{'ForeName': 'Abdoulie', 'Initials': 'A', 'LastName': 'Bojang', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Baines', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Donovan', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Guerillot', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kerrie', 'Initials': 'K', 'LastName': 'Stevens', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Higgs', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ousman', 'Initials': 'O', 'LastName': 'Secka', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Schultz', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Seemann', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Stinear', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roca', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz341']
1188,30225981,'Ripple' effect on infant zBMI trajectory of an internet-based weight loss program for low-income postpartum women.,"BACKGROUND


Weight loss interventions can have positive 'ripple' effects on untreated partners in the home, but ripple effects on infants are unknown.
OBJECTIVE


To examine whether a 12-month internet-based weight loss intervention for postpartum mothers had a positive ripple effect on participants' infants.
METHODS


A 12-month cluster randomized, assessor-blind, clinical trial enrolling 371 postpartum women at 12 Women, Infants, Children clinics in CA. Clinics were randomized to standard Women, Infants, Children or an internet-based weight loss intervention for mothers.
RESULTS


A total of 333 of the 371 (89.8%) mothers assented for infant participation. Infants were 5.3 ± 3.2 months; 75.9% were Hispanic and 64% were breastfeeding. Infant retention was 272/333 (82.7%) at 6 months post enrollment and 251/333 (75.3%) at 12 months post enrollment. In intent-to-treat analysis, a significant interaction between group and time was observed (p = 0.008) with the offspring of intervention mothers exhibiting lower zBMI change from study entry through 6 months (0.23 [CI, 0.03, 0.44] vs. 0.65 [0.50, 0.79] zBMI change, respectively; p = 0.001) but was not significant through 12 months (p = 0.16). Regardless of group, maternal reports at the final assessment indicated that infants (aged =17.2 ± 3.4 months) consumed sweetened beverages (0.93 ± 1.5/week), juice (2.0 ± 1.4/day), 'junk food' (7.8 ± 5.4/week) and fast food (2/month), and 46.7% of the infants had a TV in their bedroom.
CONCLUSIONS


An internet-based weight loss program for low-income, postpartum mothers had a positive 'ripple' effect on the zBMI of infants in the home during the first 6 months of treatment.",2019,"In intent-to-treat analysis, a significant interaction between group and time was observed (p = 0.008) with the offspring of intervention mothers exhibiting lower zBMI change from study entry through 6 months (0.23 [CI, 0.03, 0.44] vs. 0.65 [0.50, 0.79] zBMI change, respectively; p = 0.001) but was not significant through 12 months (p = 0.16).","['low-income postpartum women', '371 postpartum women at 12 Women, Infants, Children clinics in CA', 'A total of 333 of the 371 (89.8%) mothers assented for infant participation', ""postpartum mothers had a positive ripple effect on participants' infants""]","['internet-based weight loss intervention for mothers', 'internet-based weight loss intervention', 'internet-based weight loss program']","['zBMI change', 'Infant retention']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",371.0,0.182126,"In intent-to-treat analysis, a significant interaction between group and time was observed (p = 0.008) with the offspring of intervention mothers exhibiting lower zBMI change from study entry through 6 months (0.23 [CI, 0.03, 0.44] vs. 0.65 [0.50, 0.79] zBMI change, respectively; p = 0.001) but was not significant through 12 months (p = 0.16).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology and Public Health, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Hagobian', 'Affiliation': 'Department of Kinesiology and Public Health, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ventura', 'Affiliation': 'Department of Kinesiology and Public Health, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brannen', 'Affiliation': 'Department of Kinesiology and Public Health, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Erickson-Hatley', 'Affiliation': 'Departments of Health Behavior and Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schaffner', 'Affiliation': 'Statistics Department, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Muñoz-Christian', 'Affiliation': 'Modern Languages Department, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mercado', 'Affiliation': 'Department of Kinesiology and Public Health, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Departments of Health Behavior and Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Pediatric obesity,['10.1111/ijpo.12456']
1189,27995880,[Pharmacokinetics of generic dasatinib in the management of chronic myeloid leukemia in the choronie phase].,"Objective:  To evaluate the pharmacokinetics and bioequivalence of generic dasatinib in patients with chronic myeloid leukemia in the choronie phase (CML-CP).  Methods:  Using randomized, parallel, overlapping, self-control designed study, a 100 mg dose of the reference or test tablet was given to 12 CML-CP patients who were resistant or intolerant to Imatinib and Nilotinib in a randomized two-way crossover design, and the plasma concentration of the medicine was assayed by HPLC-MS-MS. The main pharmacokinetic parameters and bioequivalence of the two formulations were evaluated.  Results:  The major pharmacokinetic parameters were as follows: C max  (209.01±58.69) μg/L and (223.07±79.51) μg/L, T max  (1.1±0.8) h and (1.1±0.8) h, T 1/2  (5.10±1.34) h and (4.39±0.74) h, AUC 0-τ  (646.65±185.67) h·μg/L and (695.84±273.40) h·μg/L (all  P >0.05); AUC 0-∝  (668.11±186.00) h·μg/L and (712.42±278.08) h·μg/L, MRT (5.32 ± 1.70) h and (4.68 ± 1.53) h (all  P >0.05).  Conclusion:  The two formulations were bioequivalent.",2016,(695.84±273.40) h·μg/L (all  P >0.05);,"['12 CML-CP patients who were resistant or intolerant to Imatinib and Nilotinib', 'patients with chronic myeloid leukemia in the choronie phase (CML-CP']",['generic dasatinib'],"['AUC 0-∝', 'chronic myeloid leukemia']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1455147', 'cui_str': 'dasatinib'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]",,0.0548904,(695.84±273.40) h·μg/L (all  P >0.05);,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': ""Institute of Hematology, Peking University People's Hospital Beijing 100044, China.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Hang', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Institute of Hematology, Peking University People's Hospital Beijing 100044, China.""}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2016.11.006']
1190,31843639,"Rationale, design, and development of SleepWell24: A smartphone application to promote adherence to positive airway pressure therapy among patients with obstructive sleep apnea.","BACKGROUND


Positive airway pressure (PAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), a chronic disorder that affects 6-13% of the adult population. However, adherence to PAP therapy is challenging, and current approaches to improve adherence have limited efficacy and scalability.
METHODS/DESIGN


To promote PAP adherence, we developed SleepWell24, a multicomponent, evidence-based smartphone application that delivers objective biofeedback concerning PAP use and sleep/physical activity patterns via cloud-based PAP machine and wearable sensor data, and behavior change strategies and troubleshooting of PAP therapy interface use. This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA.
DISCUSSION


SleepWell24 is an innovative, multi-component behavior change intervention, designed as a self-management approach to addressing the psychosocial determinants of adherence to PAP therapy among new users. The results will guide lengthier future trials that assess numerous patient-centered and clinical outcomes.",2020,"This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA.
","['patients with obstructive sleep apnea', 'SleepWell24', 'patients newly diagnosed with OSA', 'obstructive sleep apnea (OSA']","['PAP therapy', 'Positive airway pressure (PAP) therapy', 'smartphone application']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],,0.033392,"This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA.
","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Petrov', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America. Electronic address: Petrov@asu.edu.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hasanaj', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Coles M', 'Initials': 'CM', 'LastName': 'Hoffmann', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America.'}, {'ForeName': 'Dana R', 'Initials': 'DR', 'LastName': 'Epstein', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America; College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Krahn', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Scottsdale, AZ, United States of America.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hollingshead', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Yu', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America.'}, {'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'St Louis', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Morgenthaler', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America. Electronic address: Matthew.Buman@asu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105908']
1191,31662328,Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial.,"OBJECTIVE


To evaluate the neuroprotective effect of therapeutic hypothermia (TH) induced by phase changing material (PCM) on MRI biomarkers in infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting.
DESIGN


Open-label randomised controlled trial.
SETTING


One neonatal intensive care unit in a tertiary care centre in India.
PATIENTS


50 term/near-term infants admitted within 5 hours after birth with predefined physiological criteria and signs of moderate/severe HIE.
INTERVENTIONS


Standard care (n=25) or standard care plus 72 hours of hypothermia (33.5°C±0.5°C, n=25) induced by PCM.
MAIN OUTCOME MEASURES


Primary outcome was fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat.
RESULTS


Primary outcome was available for 22 infants (44%, 11 in each group). Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts. After adjusting for sex, birth weight and gestational age, the mean difference in PLIC FA between groups was 0.026 (95% CI 0.004 to 0.048, p=0.023). Conventional MRI was available for 46 infants and demonstrated significantly less moderate/severe abnormalities in the cooled (n=2, 9%) than in the non-cooled (n=10, 43%) infants. There was no difference in adverse events between groups.
CONCLUSIONS


This study confirmed that TH induced by PCM reduced brain injury detected on MRI in infants with moderate HIE in a neonatal intensive care unit in India. Future research should focus on optimal supportive treatment during hypothermia rather than looking at efficacy of TH in low-resource settings.
TRIAL REGISTRATION NUMBER


CTRI/2013/05/003693.",2020,Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts.,"['50 term/near-term infants admitted within 5\u2009hours after birth with predefined physiological criteria and signs of moderate/severe HIE', 'infants with moderate HIE in a neonatal intensive care unit in India', 'neonatal hypoxic-ischaemic encephalopathy in India (THIN study', 'infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting', 'One neonatal intensive care unit in a tertiary care centre in India']","['PCM', 'Standard care (n=25) or standard care plus 72\u2009hours of hypothermia', 'Therapeutic hypothermia', 'TH', 'therapeutic hypothermia (TH) induced by phase changing material (PCM']","['adverse events', 'MRI biomarkers', 'PLIC FA', 'moderate/severe abnormalities', 'fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat']","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C1442467', 'cui_str': '5 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0152341', 'cui_str': 'Capsula Interna'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",,0.202317,Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts.,"[{'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Aker', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway karoline.aker@ntnu.no.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Støen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Live', 'Initials': 'L', 'LastName': 'Eikenes', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martinez-Biarge', 'Affiliation': 'Department of Paediatrics, Imperial College London, London, UK.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Nakken', 'Affiliation': 'Norwegian Advisory Unit for Functional MRI, Department of Radiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Asta Kristine', 'Initials': 'AK', 'LastName': 'Håberg', 'Affiliation': 'Norwegian Advisory Unit for Functional MRI, Department of Radiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Gibikote', 'Affiliation': 'Department of Radiology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Neonatology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-317311']
1192,30335422,Intraindividual variability in symptoms consistently predicts sudden gains: An examination of three independent datasets.,"OBJECTIVE


Sudden gains are robust predictors of outcome in psychotherapy. However, previous attempts at predicting sudden gains have yielded inconclusive findings. The aim of the present study was to examine a novel, transdiagnostic, transtherapeutic predictor of sudden gains that would replicate in different settings and populations. Specifically, we examined intraindividual variability in symptoms.
METHOD


We examined data from a randomized controlled trial (RCT) of prolonged exposure therapy for posttraumatic stress disorder (PTSD) in children and adolescents (n = 63), an RCT of cognitive and behavioral therapies for obsessive-compulsive disorder (OCD) in adults (n = 91), and psychodynamic therapy delivered under routine clinical conditions in a naturalistic setting for diverse disorders (n = 106). In all 3 data sets, we examined whether a measure of variability in symptoms occurring during the first sessions could predict sudden gains.
RESULTS


Variability in symptoms was found to be independent of total change during treatment. Variability in symptoms significantly predicted sudden gains in all 3 data sets and correctly classified 81.0%, 69.2%, and 76.9% of individuals to sudden gain or nonsudden gain status, respectively.
CONCLUSIONS


The present study represents the first examination of variability in symptoms as a predictor of sudden gains. Findings indicated that sudden gains are significantly predicted by intraindividual variability in symptoms, in diverse settings, contexts, and populations. Advantages of this predictor, as well as clinical and research implications are discussed. (PsycINFO Database Record (c) 2018 APA, all rights reserved).",2018,"Variability in symptoms significantly predicted sudden gains in all 3 data sets and correctly classified 81.0%, 69.2%, and 76.9% of individuals to sudden gain or nonsudden gain status, respectively.
","['posttraumatic stress disorder (PTSD) in children and adolescents (n = 63), an RCT of cognitive and behavioral therapies for obsessive-compulsive disorder (OCD) in adults (n = 91), and psychodynamic therapy delivered under routine clinical conditions in a naturalistic setting for diverse disorders (n = 106']",['prolonged exposure therapy'],['sudden gains'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C1276802', 'cui_str': 'Sudden onset'}]",,0.0445825,"Variability in symptoms significantly predicted sudden gains in all 3 data sets and correctly classified 81.0%, 69.2%, and 76.9% of individuals to sudden gain or nonsudden gain status, respectively.
","[{'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Shalom', 'Affiliation': 'Department of Psychology, University of Haifa.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gilboa-Schechtman', 'Affiliation': 'Department of Psychology, Bar-Ilan University.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Atzil-Slonim', 'Affiliation': 'Department of Psychology, Bar-Ilan University.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Bar-Kalifa', 'Affiliation': 'Department of Psychology, Bar-Ilan University.'}, {'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Hasson-Ohayon', 'Affiliation': 'Department of Psychology, Bar-Ilan University.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Department of Psychiatry and EMGO , Institute for Health and Care Research, VU University Medical Center.'}, {'ForeName': 'Anton J L M', 'Initials': 'AJLM', 'LastName': 'van Balkom', 'Affiliation': 'Department of Psychiatry and EMGO , Institute for Health and Care Research, VU University Medical Center.'}, {'ForeName': 'Idan M', 'Initials': 'IM', 'LastName': 'Aderka', 'Affiliation': 'Department of Psychology, University of Haifa.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000344']
1193,31661693,The Effectiveness of Action Observation Therapy Based on Mirror Neuron Theory in Chinese Patients with Apraxia of Speech after Stroke.,"OBJECTIVE


The present study aimed to evaluate the efficacy of action observation therapy (AOT) on apraxia of speech (AOS) in patients after stroke.
MATERIALS AND METHODS


Forty-two patients diagnosed with AOS after stroke were randomly divided into an experimental group (n = 21) and a control group (n = 21). Both groups received 30 min of conventional language therapy twice daily, 5 days a week for 4 weeks. The patients in the experimental group additionally received 20 min of AOT before 10 min language therapy each day. The speech function and aphasia severity of the 2 groups were assessed using the speech apraxia assessment method of the China Rehabilitation Research Center, Western Aphasia Battery (WAB), and the Boston Diagnostic Aphasia Examination before and after treatment.
RESULTS


AOS and WAB scores increased significantly after treatment in both groups (p < 0.05). AOS and WAB scores exhibited significant differences between the experimental group and the control group after training (p < 0.05). The response rate in the experimental group was significantly higher than that in the control group (p < 0.05).
CONCLUSION


AOT based on mirror neuron theory may improve language function in patients with AOS after stroke.",2019,"The response rate in the experimental group was significantly higher than that in the control group (p < 0.05).
","['Chinese Patients with Apraxia of Speech after Stroke', 'Forty-two patients diagnosed with AOS after stroke', 'patients with AOS after stroke', 'patients after stroke']","['Action Observation Therapy', 'conventional language therapy', 'action observation therapy (AOT']","['AOS and WAB scores', 'apraxia of speech (AOS', 'speech function and aphasia severity', 'speech apraxia assessment method of the China Rehabilitation Research Center, Western Aphasia Battery (WAB), and the Boston Diagnostic Aphasia Examination', 'response rate', 'language function']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264611', 'cui_str': 'Apraxia of Phonation'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023017', 'cui_str': 'Language Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0264611', 'cui_str': 'Apraxia of Phonation'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1514830', 'cui_str': 'Rehabilitation Research'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0451580', 'cui_str': 'Western aphasia battery (assessment scale)'}, {'cui': 'C0451036', 'cui_str': 'Boston Diagnostic Aphasia Examination'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]",42.0,0.0250256,"The response rate in the experimental group was significantly higher than that in the control group (p < 0.05).
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'You', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Zhongda Hospital Southeast University, Nanjing, China.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation, Brain Hospital Affiliated to Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Shan', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China, neuroscl@163.com.'}]",European neurology,['10.1159/000503960']
1194,30587088,Recruitment of Schools for Intervention Research to Reduce Health Disparities for Sexual and Gender Minority Students.,"Recruiting schools for intervention research can be daunting. This study examined the experiences of researchers recruiting public high schools for a randomized controlled trial to reduce suicide disparities for sexual and gender minority (SGM) youth by implementing evidence-based strategies to enhance school environments. We enrolled 42 schools throughout New Mexico between August 2016 and April 2017. Based on qualitative analysis of recruitment efforts, three groups of factors affected enrollment: (1) non-SGM-specific factors, (2) SGM-specific factors, and (3) facilitating factors. Non-SGM-specific factors negatively impacted the willingness or ability to participate (e.g., demanding staff workloads and beliefs that ""outsiders"" should not assist with school-based interventions). Notable SGM-specific factors centered on influences in socially conservative community environments and beliefs that schools lacked SGM students. Advocacy, leveraging relationships, and persistence were facilitating factors for overcoming recruitment obstacles. Our findings have implications for researchers and school nurses interested in school-based interventions, especially those focused on SGM youth.",2020,"Non-SGM-specific factors negatively impacted the willingness or ability to participate (e.g., demanding staff workloads and beliefs that ""outsiders"" should not assist with school-based interventions).","['Sexual and Gender Minority Students', 'We enrolled 42 schools throughout New Mexico between August 2016 and April 2017']",[],[],"[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],[],42.0,0.0188143,"Non-SGM-specific factors negatively impacted the willingness or ability to participate (e.g., demanding staff workloads and beliefs that ""outsiders"" should not assist with school-based interventions).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Shattuck', 'Affiliation': 'Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}, {'ForeName': 'Janie Lee', 'Initials': 'JL', 'LastName': 'Hall', 'Affiliation': 'Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'The Trevor Project, Los Angeles, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Greenberg', 'Affiliation': 'Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Peñaloza', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Willging', 'Affiliation': 'Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840518820103']
1195,31448126,Elevated serum complement levels and higher gene copy number of complement  C4B  are associated with hypertension and effective response to statin therapy in childhood-onset systemic lupus erythematosus (SLE).,"Objective


Systemic lupus erythematosus (SLE) features high frequency of cardiovascular disease (CVD) and fluctuating complement levels. The clinical trial Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) aimed to evaluate whether atorvastatin treatment reduced the progression of atherosclerosis in 221 patients with childhood-onset SLE (cSLE), using carotid intima media thickness (CIMT) as surrogates. We leveraged APPLE biorepository and trial data to investigate the relationship between  complement  and CVD in cSLE.
Methods


Gene copy numbers (GCNs) for total  C4 ,  C4A  and  C4B  were measured by TaqMan-based real-time PCR and Southern blotting, and analysed with laboratory and clinical parameters through Student's t-test and χ 2  analyses. Effects of total  C4 ,  C4A  and  C4B  GCNs on the response to placebo or atorvastatin treatment and progression of CIMT were examined by regression analyses.
Results


At baseline, C4 protein levels strongly correlated with GCNs of total  C4  (p=1.8×10 -6 ). Each copy of  C4  gene increased mean serum C4 by 3.28 mg/dL. Compared with those without hypertension (N=142), individuals with hypertension demonstrated significantly elevated serum levels for C4 and C3 at baseline and serially (C4: P=5.0×10 -25 ; C3: P=5.84×10 -20 ). Individuals with ≥2  C4B  genes had 2.5 times the odds of having hypertension (p=0.016) and higher diastolic blood pressure (p=0.015) compared with those with  C4B  deficiency. At the study end, subjects with ≥2  C4B  and atorvastatin treatment had significantly slower increase in CIMT compared with those treated with placebo (p=0.018).
Conclusions


cSLE with hypertension had elevated serum levels of C4 and C3 and higher GCN of  C4B ; cSLE with ≥2  C4B  genes would benefit from statins therapy to prevent atherosclerosis.",2019,"Each copy of  C4  gene increased mean serum C4 by 3.28 mg/dL. Compared with those without hypertension (N=142), individuals with hypertension demonstrated significantly elevated serum levels for C4 and C3 at baseline and serially (C4: P=5.0×10 -25 ; C3: P=5.84×10 -20 ).","['Pediatric Lupus Erythematosus (APPLE', '221 patients with childhood-onset SLE (cSLE), using carotid intima media thickness (CIMT) as surrogates']","['statin therapy', 'placebo or atorvastatin', 'placebo', 'atorvastatin']","['CIMT', 'having hypertension', 'diastolic blood pressure', 'Methods\n\n\nGene copy numbers (GCNs) for total  C4 ,  C4A  and  C4B', 'mean serum C4', 'C4 protein levels']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0178655', 'cui_str': 'Gene Copy Number'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",221.0,0.107465,"Each copy of  C4  gene increased mean serum C4 by 3.28 mg/dL. Compared with those without hypertension (N=142), individuals with hypertension demonstrated significantly elevated serum levels for C4 and C3 at baseline and serially (C4: P=5.0×10 -25 ; C3: P=5.84×10 -20 ).","[{'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Mulvihill', 'Affiliation': ""Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Ardoin', 'Affiliation': ""Division of Rheumatology, Nationwide Children's Hospitatl, Columbus, OH, USA.""}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Thompson', 'Affiliation': ""Center for Autoimmune Genomics and Etiology, Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio, USA.""}, {'ForeName': 'Bi', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Center for Microbial Pathogenesis, Abigail Wexner Research Institute, Columbus, Ohio, USA.'}, {'ForeName': 'Gakit Richard', 'Initials': 'GR', 'LastName': 'Yu', 'Affiliation': ""Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'King', 'Affiliation': ""Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Singer', 'Affiliation': 'Department of Medicine, University Hospitals/Case Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Levy', 'Affiliation': 'Department of Rheumatology, Hospital for Sick Children and Univeristy of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Hermine', 'Initials': 'H', 'LastName': 'Brunner', 'Affiliation': ""Department of Pediatrics, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Yee Ling', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Microbiology and Immunology, Loyola University Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Haikady N', 'Initials': 'HN', 'LastName': 'Nagaraja', 'Affiliation': 'Division of Biostatistics, College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Laura Eve', 'Initials': 'LE', 'LastName': 'Schanberg', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Chack-Yung', 'Initials': 'CY', 'LastName': 'Yu', 'Affiliation': ""Division of Rheumatology, Nationwide Children's Hospitatl, Columbus, OH, USA.""}]",Lupus science & medicine,['10.1136/lupus-2019-000333']
1196,29781068,Pelvic Floor Muscle Training With Or Without Tibial Nerve Stimulation and Lifestyle Changes Have Comparable Effects on The Overactive Bladder. A Randomized Clinical Trial.,"PURPOSE


To compare effects of transcutaneous posterior tibial nerve stimulation (TPTNS) and pelvic floor muscle training (PFMT) in women with overactive bladder syndrome (OAB).
MATERIAL AND METHODS


We randomized 67 women ? 18 years with OAB to three parallel groups: group I (n = 22) received life-style recommendations (LSR) only; group II (n = 24) had LSR + PFMT and group III (n = 21) had LSR + PFMT + TPTNS. Urgency, evaluated by a 3-day voiding diary before treatment and six weeks later, was the main outcome measure. The King's College Health Questionnaire was also administered.
RESULTS


Urgency was significantly reduced in all three groups from 5.1 ± 3.7 to 3.8 ± 3.2 episodes/day, P = .016 in group I, from 5.2 ± 3.6 to 3.2 ± 2.9, P = .006 in group II and from 6.8 ± 3.1 to 4.4 ± 3.5 in group III, P = .013. There were no intergroup differences. The questionnaire results improved significantly only in group III as regards general health perception, role limitation, physical and social limitations without intergroup differences. Womenimproved their micturition frequency in two groups from 8.9 ± 3.2 to 7.5 ± 2.3 episodes/per day, P = .025 in group II, and from 8.8 ± 2.3 to 7.4 ± 2.0, P = .001 in group III, but only in group II was a significant reduction of urinary incontinence seen from 3.8 ± 4.6 to 2.9 ± 4.8 episodes/day, P = .045.
CONCLUSION


All three treatments lead to effective short-term reduction of urgency in women with OAB, but longterm efficacy evaluation is required.",2018,"The questionnaire results improved significantly only in group III as regards general health perception, role limitation, physical and social limitations without intergroup differences.","['We randomized 67 women ', 'women with OAB', '18 years with OAB', 'women with overactive bladder syndrome (OAB']","['LSR + PFMT + TPTNS', 'LSR + PFMT', 'Pelvic Floor Muscle Training With Or Without', 'transcutaneous posterior tibial nerve stimulation (TPTNS) and pelvic floor muscle training (PFMT', 'life-style recommendations (LSR']","['Urgency', 'urinary incontinence', '3-day voiding diary', 'general health perception, role limitation, physical and social limitations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",67.0,0.0247262,"The questionnaire results improved significantly only in group III as regards general health perception, role limitation, physical and social limitations without intergroup differences.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Bykoviene', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, Kaunas, Lithuania. lina.bykoviene@lsmuni.lt.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Rosita', 'Initials': 'R', 'LastName': 'Aniuliene', 'Affiliation': 'Department of Obstetrics and Gynecology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Bartuseviciene', 'Affiliation': 'Department of Obstetrics and Gynecology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Arnoldas', 'Initials': 'A', 'LastName': 'Bartusevicius', 'Affiliation': 'Department of Obstetrics and Gynecology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Urology journal,['10.22037/uj.v0i0.4169']
1197,29681046,Long-term Effect of Colchicine Treatment in Preventing Urethral Stricture Recurrence After Internal Urethrotomy.,"PURPOSE


Urethral stricture, known as a scar formation leading to urethral lumen stricture in sub-epithelial tissue, is the most common late complication of transurethral prostate resection (TURP). The aim of study is to evaluate efficacy of colchicine treatment in preventing urethral stricture recurrence in patients after internal urethrotomy, and to determine whether colchicine treatment had a sustained effect in decreasing stricture recurrences in patients with concomitant diseases.
METHODS


Patient data with weak urine stream and/or voiding difficulty, and who had internal urethrotomy in Urology Department of Maltepe University Hospital between dates 01 January 2011 and December 2016 were collected. They were randomized to colchicine receiving, and non-receiving arms. Colchicine was given 1 g/day orally for two months, and primary efficacy point was defined as urethral stricture development in 3, 6, and 12 months after internal urethrotomy.
RESULTS


The study was conducted on 84 males with the mean age of 67.7 ± 7.5 years. The mean ages of colchicine receivers and non-receivers were 68.2 ± 7.6 and 67.1 ± 7.6 years, respectively. Recurrence rate of urethral stricture was significantly lower in colchicine receivers (P = .044) than non-receivers. In overall evaluation, recurrence rate of urethral stricture was significantly low, if there was only one comorbidity (P = .006), but rates were significantly higher in presence of three (P = .010) and four (P = .040) comorbidities. No significant difference in recurrencerates was determined in patients without comorbidities or with two comorbidities (P > .05).
CONCLUSION


Combination of oral colchicine with internal urethrotomy reduces recurrence rates of urethral stricturesignificantly.",2018,Recurrence rate of urethral stricture was significantly lower in colchicine receivers (P = .044) than non-receivers.,"['Patient data with weak urine stream and/or voiding difficulty, and who had internal urethrotomy in Urology Department of Maltepe University Hospital between dates 01 January 2011 and December 2016 were collected', 'patients after internal urethrotomy', 'patients with concomitant diseases', '84 males with the mean age of 67.7 ± 7.5 years']","['Colchicine', 'transurethral prostate resection (TURP', 'colchicine']","['stricture recurrences', 'recurrence rates of urethral stricturesignificantly', 'urethral stricture recurrence', 'Recurrence rate of urethral stricture', 'Urethral Stricture Recurrence', 'recurrence rate of urethral stricture', 'urethral stricture development', 'recurrencerates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0442540', 'cui_str': 'Streams'}, {'cui': 'C0241705', 'cui_str': 'Painful urging to urinate (finding)'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0587531', 'cui_str': 'Urology department (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0243087', 'cui_str': 'concomitant disease'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",84.0,0.0246675,Recurrence rate of urethral stricture was significantly lower in colchicine receivers (P = .044) than non-receivers.,"[{'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Sinanoglu', 'Affiliation': 'Urology Department, Maltepe University Faculty of Medicine, Istanbul Turkey. orhundr@hotmail.com.'}, {'ForeName': 'Fatih Osman', 'Initials': 'FO', 'LastName': 'Kurtulus', 'Affiliation': 'Urology Clinic Kolan Hospital, Istanbul Turkey.'}, {'ForeName': 'Feride Sinem', 'Initials': 'FS', 'LastName': 'Akgün', 'Affiliation': 'Emergency Department, Maltepe University Faculty of Medicine, Istanbul Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4198']
1198,30558818,"Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres.","BACKGROUND


A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.
METHODS


This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.
RESULTS


The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.
CONCLUSIONS


IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains.
CLINICAL TRIAL REGISTRATION


EudraCT no. 2013-001231-51.",2019,"Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains.","['Healthy children aged 6-35\u202fmonths not previously vaccinated against influenza', '4980 participants completing the study according to protocol, was demonstrated for IIV4', 'children aged 6-35\u202fmonths', '5806 participants', 'Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons', 'Northern and Southern Hemispheres', 'Europe in 2016 for individuals aged\u202f≥\u202f3\u202fyears']","['placebo, the licensed trivalent split-virion inactivated vaccine (IIV3', 'placebo', 'EudraCT', 'quadrivalent inactivated influenza vaccine', 'quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata']","['Safety profiles', 'injection-site reactions', 'Vaccine efficacy', 'efficacy against influenza illness', 'efficacy and safety', 'Efficacy, immunogenicity, and safety']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",5806.0,0.3056,"Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pepin', 'Affiliation': ""Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Stephanie.Pepin@sanofipasteur.com.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dupuy', 'Affiliation': ""Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofi.com.""}, {'ForeName': 'Charissa Fay Corazon', 'Initials': 'CFC', 'LastName': 'Borja-Tabora', 'Affiliation': 'Research Institute for Tropical Medicine, Muntinlupa City, Philippines.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Montellano', 'Affiliation': 'Mary Chiles General Hospital, Manila, Philippines.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Bravo', 'Affiliation': 'University of the Philippines Manila - National Institutes of Health, Manila, Philippines.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': ""Philippine Children's Medical Center, Quezon City, Philippines. Electronic address: jimson2@me.com.""}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'de Castro', 'Affiliation': 'DLSUMC De La Salle Health Sciences Institute, Dasmariñas, Cavite, Philippines.'}, {'ForeName': 'Doris Maribel', 'Initials': 'DM', 'LastName': 'Rivera-Medina', 'Affiliation': 'Inversiones en Investigación Médica S.A, Tegucigalpa, Honduras.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cutland', 'Affiliation': 'Chris Hani Baragwanath Hospital, Johannesburg, South Africa. Electronic address: cutlandc@rmpru.co.za.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ariza', 'Affiliation': 'Caimed Dominicana A.S. Investigacion en Salud, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diez-Domingo', 'Affiliation': 'FISABIO-Public Health, Valencia, Spain.'}, {'ForeName': 'Celia Diaz', 'Initials': 'CD', 'LastName': 'Gonzalez', 'Affiliation': 'Hospital Infantil La Paz, Madrid, Spain. Electronic address: celiac.diaz@salud.madrid.org.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Martinón-Torres', 'Affiliation': 'Translational Pediatrics and Infectious Diseases, Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago, Universidad de Santiago, Spain. Electronic address: Federico.Martinon.Torres@sergas.es.'}, {'ForeName': 'Efimia', 'Initials': 'E', 'LastName': 'Papadopoulou-Alataki', 'Affiliation': 'School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. Electronic address: efiala@otenet.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Theodoriadou', 'Affiliation': ""Children's Hospital Aghia Sofia, Athens, Greece. Electronic address: mpapagrig@med.uoa.gr.""}, {'ForeName': 'Marie Pierre', 'Initials': 'MP', 'LastName': 'Kazek-Duret', 'Affiliation': ""Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Marie-Pierre.Kazek-Duret@sanofi.com.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: Sanjay.Gurunathan@sanofi.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Bruijn', 'Affiliation': ""Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Iris.DeBruijn@sanofi.com.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2018.11.074']
1199,31253718,Evidence that an intervention weakens the relationship between adolescent electronic cigarette use and tobacco smoking: a 24-month prospective study.,"BACKGROUND


The electronic cigarette (e-cigarette) use to subsequent smoking relationship in adolescents has received much attention. Whether an intervention to reduce smoking initiation attenuated this relationship was assessed.
METHOD


Data were from 3994 adolescent never smokers (aged 13-14 years at baseline) as part of a cluster randomised controlled trial. Self-report measures of smoking, e-cigarette use and covariates were assessed and used to predict ever smoked cigarettes, any recent tobacco smoking and regularly smoked cigarettes at 24-month follow-up.
RESULTS


Baseline ever use of e-cigarettes was associated with ever smoked cigarettes (OR=4.03, 95% CI 3.33 to 4.88; controlling for covariates, OR=2.78, 95% CI 2.20 to 3.51), any recent tobacco smoking (OR=3.38, 95% CI 2.72 to 4.21; controlling for covariates, OR=2.17, 95% CI 1.76 to 2.69) and regularly smoked cigarettes (OR=3.60, 95% CI 2.35 to 5.51; controlling for covariates, OR=1.27, 95% CI 1.17 to 1.39) at follow-up. For ever smoked cigarettes only, the impact of e-cigarette use was attenuated in the intervention (OR=1.83) compared with control (OR=4.53) condition. For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)).
CONCLUSIONS


This is one of the first studies to show that e-cigarette use was robustly associated with measures of smoking over 24 months and the first to show an intervention to attenuate the relationship. Further research with a broader age range of adolescents is required.",2020,"For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)).
",['Data were from 3994 adolescent never smokers (aged 13-14 years at baseline'],[],"['adolescent electronic cigarette use and tobacco smoking', 'regularly smoked cigarettes', 'recent tobacco smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]",,0.0288669,"For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)).
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK m.t.conner@leeds.ac.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grogan', 'Affiliation': 'Department of Psychology, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Simms-Ellis', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Flett', 'Affiliation': 'Faculty of Health Sciences, Staffordshire University, Staffordshire, UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Sykes-Muskett', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cowap', 'Affiliation': 'Faculty of Health Sciences, Staffordshire University, Staffordshire, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Armitage', 'Affiliation': 'Psychology, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Schmitt', 'Affiliation': 'Academic Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Torgerson', 'Affiliation': 'Education, Durham University, Durham, Durham, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Institute of Health Sciences, University of York, York, North Yorkshire, UK.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054905']
1200,29880301,Effectiveness of targeted enhanced terminal room disinfection on hospital-wide acquisition and infection with multidrug-resistant organisms and Clostridium difficile: a secondary analysis of a multicentre cluster randomised controlled trial with crossover design (BETR Disinfection).,"BACKGROUND


The hospital environment is a source of pathogen transmission. The effect of enhanced disinfection strategies on the hospital-wide incidence of infection has not been investigated in a multicentre, randomised controlled trial. We aimed to assess the effectiveness of four disinfection strategies on hospital-wide incidence of multidrug-resistant organisms and Clostridium difficile in the Benefits of Enhanced Terminal Room (BETR) Disinfection study.
METHODS


We did a prespecified secondary analysis of the results from the BETR Disinfection study, a pragmatic, multicentre, crossover cluster-randomised trial that assessed four different strategies for terminal room disinfection in nine hospitals in the southeastern USA. Rooms from which a patient with a specific infection or colonisation (due to the target organisms C difficile, meticillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci (VRE), or multidrug-resistant Acinetobacter spp) was discharged were terminally disinfected with one of four strategies: standard disinfection (quaternary ammonium disinfectant, except for C difficile, for which 10% hypochlorite [bleach] was used; reference); standard disinfection and disinfecting ultraviolet light (UV-C), except for C difficile, for which bleach and UV-C was used (UV strategy); 10% hypochlorite (bleach strategy); and bleach and UV-C (bleach and UV strategy). We randomly assigned the sequence of strategies for each hospital (1:1:1:1), and each strategy was used for 7 months, including a 1-month wash-in period and 6 months of data collection. The prespecified secondary outcomes were hospital-wide, hospital-acquired incidence of all target organisms (calculated as number of patients with hospital-acquired infection with a target organism per 10 000 patient days), and hospital-wide, hospital-acquired incidence of each target organism separately. BETR Disinfection is registered with ClinicalTrials.gov, number NCT01579370.
FINDINGS


Between April, 2012, and July, 2014, there were 271 740 unique patients with 375 918 admissions. 314 610 admissions met all inclusion criteria (n=73 071 in the reference study period, n=81 621 in the UV study period, n=78 760 in the bleach study period, and n=81 158 in the bleach and UV study period). 2681 incidenct cases of hospital-acquired infection or colonisation occurred during the study. There was no significant difference in the hospital-wide risk of target organism acquisition between standard disinfection and the three enhanced terminal disinfection strategies for all target multidrug-resistant organisms (UV study period relative risk [RR] 0·89, 95% CI 0·79-1·00; p=0·052; bleach study period 0·92, 0·79-1·08; p=0·32; bleach and UV study period 0·99, 0·89-1·11; p=0·89). The decrease in risk in the UV study period was driven by decreases in risk of acquisition of C difficile (RR 0·89, 95% CI 0·80-0·99; p=0·031) and VRE (0·56, 0·31-0·996; p=0·048).
INTERPRETATION


Enhanced terminal room disinfection with UV in a targeted subset of high-risk rooms led to a decrease in hospital-wide incidence of C difficile and VRE. Enhanced disinfection overcomes limitations of standard disinfection strategies and is a potential strategy to reduce the risk of acquisition of multidrug-resistant organisms and C difficile.
FUNDING


US Centers for Disease Control and Prevention.",2018,There was no significant difference in the hospital-wide risk of target organism acquisition between standard disinfection and the three enhanced terminal disinfection strategies for all target multidrug-resistant organisms (UV study period relative risk [RR],"['314\u2008610 admissions met all inclusion criteria (n=73\u2008071 in the reference study period, n=81\u2008621 in the UV study period, n=78\u2008760 in the bleach study period, and n=81\u2008158 in the bleach and UV study period', 'nine hospitals in the southeastern USA', 'Between April, 2012, and July, 2014, there were 271\u2008740 unique patients with 375\u2008918 admissions']","['enhanced disinfection strategies', 'targeted enhanced terminal room disinfection', 'standard disinfection and disinfecting ultraviolet light (UV-C), except for C difficile, for which bleach and UV-C was used (UV strategy); 10% hypochlorite (bleach strategy); and bleach and UV-C (bleach and UV strategy']","['hospital-acquired infection or colonisation', 'hospital-wide, hospital-acquired incidence of all target organisms (calculated as number of patients with hospital-acquired infection with a target organism per 10\u2008000 patient days), and hospital-wide, hospital-acquired incidence of each target organism separately', 'risk of acquisition of C difficile', 'hospital-wide risk of target organism acquisition']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}]","[{'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet Light'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C0122922', 'cui_str': 'Hypochlorite'}]","[{'cui': 'C0205721', 'cui_str': 'Infections, Hospital'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0456393', 'cui_str': 'Hospital acquired (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0029235', 'cui_str': 'Organism - attribute'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.299442,There was no significant difference in the hospital-wide risk of target organism acquisition between standard disinfection and the three enhanced terminal disinfection strategies for all target multidrug-resistant organisms (UV study period relative risk [RR],"[{'ForeName': 'Deverick J', 'Initials': 'DJ', 'LastName': 'Anderson', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: deverick.anderson@duke.edu.'}, {'ForeName': 'Rebekah W', 'Initials': 'RW', 'LastName': 'Moehring', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Durham Veterans Affairs Medical Center, Durham, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Weber', 'Affiliation': 'Department of Hospital Epidemiology, University of North Carolina Health Care, Chapel Hill, NC, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Lewis', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Luke F', 'Initials': 'LF', 'LastName': 'Chen', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'J Conrad', 'Initials': 'JC', 'LastName': 'Schwab', 'Affiliation': 'Chesapeake Regional Medical Center, Chesapeake, VA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Becherer', 'Affiliation': 'Rex Healthcare, Raleigh, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blocker', 'Affiliation': 'Alamance Regional Medical Center, Burlington, NC, USA; Carolinas Medical Center, Charlotte, NC, USA.'}, {'ForeName': 'Patricia F', 'Initials': 'PF', 'LastName': 'Triplett', 'Affiliation': 'High Point Regional Hospital, High Point, NC, USA.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Knelson', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Centre, Durham, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Rutala', 'Affiliation': 'Department of Hospital Epidemiology, University of North Carolina Health Care, Chapel Hill, NC, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sexton', 'Affiliation': 'Duke Center for Antimicrobial Stewardship and Infection Prevention, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30278-0']
1201,30585101,Comparison of bilateral and unilateral umbilical artery diastolic blood flow abnormalities in monochorionic diamniotic twin pregnancies.,"Aim:  Our study aimed to clarify the prognosis of bilateral and unilateral umbilical artery end-diastolic blood flow abnormalities (BFAs) in monochorionic diamniotic twin pregnancies. Methods:  Monochorionic diamniotic twin pregnancies were classified into bilateral (group 1), unilateral (group 2), and no (group 3) umbilical artery end-diastolic BFAs. After the usual obstetric management, short- and long-term prognoses were analyzed. Results:  A total of 171 monochorionic diamniotic twins were analyzed and classified into group 1 (13 twins, 7.6%), 2 (12 twins, 7.0%), and 3 (146 twins, 85.4%). Gestational age at delivery was significantly lower in group 1 than in groups 2 and 3 (median, 29.3, 35.6, and 35.6 weeks, respectively;  p  < .01 and  p  < .001). The survival rate of fetuses with BFAs was significantly lower in group 1 than in group 2 (23.0% [3/13] versus 100% [12/12];  p  < .001). However, the survival rate of the co-twin was not significantly different between groups 1 and 2 (84.6% [11/13] versus 100% [12/12];  p  = .48). The survival rate of both fetuses was significantly lower in group 1 than in groups 2 and 3 (53.8% [14/26], 100% [24/24], and 98.6% [288/292], respectively; both  p  < .001). In cases with fetal therapy, the survival rate of both fetuses tended to be lower in group 1 than in group 2 (44.4% [8/18] versus 83.3% [10/12];  p  = .05). In cases without fetal therapy, the gestational age at delivery tended to lower in group 1 than in group 2 and was significantly lower than in group 3 (median, 29.1, 35.6, 35.6 weeks, respectively;  p  = .05 and  p  < .05). The survival rate of fetuses with BFA tended to be lower in group 1 than in group 2 (50.0% [2/4] versus 100% [12/12];  p  = .05). The survival rate of the co-twin was not significantly different between groups 1 and 2 (100% [4/4] versus 100% [12/12];  p  = 1). The survival rate of both fetuses tended to be lower in group 1 than in group 2 and was significantly lower than in group 3 (75% [6/8], 100% [24/24], and 99.2% [278/280], respectively;  p  = .05 and  p  < .01). Conclusions:  In monochorionic diamniotic twin pregnancies, bilateral umbilical artery end-diastolic BFAs demonstrated a poor prognosis. However, unilateral abnormalities exhibited a good prognosis similar to that in twins with normal umbilical artery blood flow. If such abnormalities are detected during a routine checkup, the umbilical artery pulse wave on the other side should be examined.",2020,"In cases with fetal therapy, the survival rate of both fetuses tended to be lower in group 1 than in group 2 (44.4% [8/18] versus 83.3% [10/12]; p = 0.05).","['twins with normal umbilical artery blood flow', 'monochorionic diamniotic twin pregnancies', '171 monochorionic diamniotic twins were analyzed and classified into group 1 (13 twins, 7.6%), 2 (12 twins, 7.0%), and 3 (146 twins, 85.4', 'Monochorionic diamniotic twin pregnancies']","['bilateral and unilateral umbilical artery end-diastolic blood flow abnormalities (BFAs', 'bilateral and unilateral umbilical artery diastolic blood flow abnormalities']","['survival rate', 'survival rate of fetuses with BFA', 'survival rate of the co-twin', 'gestational age at delivery', 'survival rate of both fetuses', 'bilateral umbilical artery end-diastolic BFAs', 'Gestational age at delivery', 'survival rate of fetuses with BFAs']","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C2977401', 'cui_str': 'Monochorionic diamniotic twin pregnancy (disorder)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0654146', 'cui_str': '4,4-difluoro-5-methyl-4-bora-3,4-diaza-3-indacenedodecanoic acid'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",171.0,0.0286146,"In cases with fetal therapy, the survival rate of both fetuses tended to be lower in group 1 than in group 2 (44.4% [8/18] versus 83.3% [10/12]; p = 0.05).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Katsura', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Iwagaki', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Chiaki', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Matsui', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'Nagai', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Yasumi', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Fetal-Maternal Medicine, Nagara Medical Center, Nagara, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiga University of Medical Science Hospital, Otsu, Japan.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1564031']
1202,30375661,A randomised controlled trial of protocolised music therapy demonstrates developmental milestone acquisition in hospitalised infants.,"AIM


To compare the effectiveness of an intensive-intermittent vs. standard spaced protocolised music therapy intervention on supporting developmental milestone acquisition of infants >44 weeks postmenstrual age (PMA) hospitalised in a Neonatal Intensive Care Unit (NICU).
METHOD


This was a comparative effectiveness study of infants 44-66 weeks PMA with a projected NICU stay of at least one month from recruitment. Infants were randomised to one of two treatment groups: traditional therapy (2x/week) and intermittent-intensive (4x/week, off, 4x/week, off). Both groups received the same number of sessions over a 4-week period. Sessions at the start and end of the treatment period were video recorded. Two masked researchers reviewed and coded videos. Milestones used for video recording were adapted from the Developmental Assessment of Young Children.
RESULTS


Twenty-four infants participated, with groups matched for birth age, PMA at start of study, race, IVH severity, and respiratory support. Total and motor composite scores were higher post-intervention (Cohen's d = 0.71 and 0.97, both p < 0.01), with the same degree of skill acquisition found for both intervention groups.
CONCLUSION


A developmental music therapy protocol supports developmental skills acquisition of post-term infants in a NICU. Similar outcomes for both groups provide therapists with varying treatment dosing options to best support their patients.",2019,"Total and motor composite scores were higher post-intervention (Cohen's d = 0.71 and 0.97,","['infants 44-66\xa0weeks', 'infants >44\xa0weeks postmenstrual age (PMA) hospitalised in a Neonatal Intensive Care Unit (NICU', 'hospitalised infants', 'post-term infants in a NICU']","['protocolised music therapy', 'intensive-intermittent vs. standard spaced protocolised music therapy intervention', 'traditional therapy (2x/week) and intermittent-intensive']",['Total and motor composite scores'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0021293', 'cui_str': 'Infant, Postmature'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C3650840', 'cui_str': 'Traditional therapy (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",24.0,0.0592268,"Total and motor composite scores were higher post-intervention (Cohen's d = 0.71 and 0.97,","[{'ForeName': 'Lelia', 'Initials': 'L', 'LastName': 'Emery', 'Affiliation': ""Nationwide Children's Hospital, Perinatal Research Institute, Columbus, OH, USA.""}, {'ForeName': 'Ellyn L', 'Initials': 'EL', 'LastName': 'Hamm', 'Affiliation': ""Nationwide Children's Hospital, Perinatal Research Institute, Columbus, OH, USA.""}, {'ForeName': 'Kaleigh', 'Initials': 'K', 'LastName': 'Hague', 'Affiliation': ""Nationwide Children's Hospital, Perinatal Research Institute, Columbus, OH, USA.""}, {'ForeName': 'Olena D', 'Initials': 'OD', 'LastName': 'Chorna', 'Affiliation': ""Nationwide Children's Hospital, Perinatal Research Institute, Columbus, OH, USA.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Moore-Clingenpeel', 'Affiliation': ""Nationwide Children's Hospital, Biostatistics Research Core, Columbus, OH, USA.""}, {'ForeName': 'Nathalie L', 'Initials': 'NL', 'LastName': 'Maitre', 'Affiliation': ""Nationwide Children's Hospital, Perinatal Research Institute, Columbus, OH, USA.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14628']
1203,31657981,Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16.,"PURPOSE


Despite contemporary treatment, up to 10% of children with acute lymphoblastic leukemia still experience relapse. We evaluated whether a higher dosage of PEG-asparaginase and early intensification of triple intrathecal therapy would improve systemic and CNS control.
PATIENTS AND METHODS


Between 2007 and 2017, 598 consecutive patients age 0 to 18 years received risk-directed chemotherapy without prophylactic cranial irradiation in the St Jude Total Therapy Study 16. Patients were randomly assigned to receive PEG-asparaginase 3,500 U/m 2  versus the conventional 2,500 U/m 2 . Patients presenting features that were associated with increased risk of CNS relapse received two extra doses of intrathecal therapy during the first 2 weeks of remission induction.
RESULTS


The 5-year event-free survival and overall survival rates for the 598 patients were 88.2% (95% CI, 84.9% to 91.5%) and 94.1% (95% CI, 91.7% to 96.5%), respectively. Cumulative risk of any-isolated or combined-CNS relapse was 1.5% (95% CI, 0.5% to 2.5%). Higher doses of PEG-asparaginase did not affect treatment outcome. T-cell phenotype was the only independent risk factor for any CNS relapse (hazard ratio, 5.15; 95% CI, 1.3 to 20.6;  P  = . 021). Among 359 patients with features that were associated with increased risk for CNS relapse, the 5-year rate of any CNS relapse was significantly lower than that among 248 patients with the same features treated in the previous Total Therapy Study 15 (1.8% [95% CI, 0.4% to 3.3%]  v  5.7% [95% CI, 2.8% to 8.6%];  P  = .008). There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
CONCLUSION


Higher doses of PEG-asparaginase failed to improve outcome, but additional intrathecal therapy during early induction seemed to contribute to improved CNS control without excessive toxicity for high-risk patients.",2019,"There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
","['Between 2007 and 2017, 598 consecutive patients age 0 to 18 years received', '359 patients with features', 'children with acute lymphoblastic leukemia still experience relapse']","['PEG-asparaginase', 'risk-directed chemotherapy without prophylactic cranial irradiation', 'PEG-asparaginase 3,500 U/m 2  versus the conventional 2,500 U/m 2 ']","['cumulative risk of seizure or infection', 'risk for CNS relapse', 'risk of CNS relapse', '5-year event-free survival and overall survival rates', '5-year rate of any CNS relapse', 'Cumulative risk of any-isolated or combined-CNS relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",598.0,0.0488517,"There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
","[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Deqing', 'Initials': 'D', 'LastName': 'Pei', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Sandlund', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Coustan-Smith', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Campana', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Ribeiro', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Susana C', 'Initials': 'SC', 'LastName': 'Raimondi', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Raja B', 'Initials': 'RB', 'LastName': 'Khan', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Mullighan', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Evans', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01692']
1204,30453852,Intensive Patients' Education and Lifestyle Improving Program in CAD Patients.,"The objective of this article is to investigate the effects of intensive patients' education and lifestyle improving program (IPEL) on anxiety, depression, and overall survival (OS) in coronary artery disease (CAD) patients with anxiety and depression. In all, 224 CAD patients with anxiety and depression were randomly assigned to IPEL or control group. In Stage I, the IPEL group received IPEL and usual care, while the control group only received usual care. In Stage II, patients were further followed up and OS analysis was performed. Hospital Anxiety and Depression Scale-anxiety (HADS-A) and HADS-depression (HADS-D) were used to assess anxiety and depression. IPEL reduced HADS-A score at Month 9 (M9)/M12, and the percentage of anxiety at M12 and HADS-A score changed. IPEL reduced HADS-D score at M12, and the percentage of depression at M12 and HADS-D score changed compared with control. Patients with nonanxiety/nondepression at M12 in the IPEL group showed better OS. IPEL reduces anxiety and depression and improves OS in CAD patients.",2019,"IPEL reduced HADS-D score at M12, and the percentage of depression at M12 and HADS-D score changed compared with control.","[""Intensive Patients' Education and Lifestyle Improving Program in CAD Patients"", '224 CAD patients with anxiety and depression', 'coronary artery disease (CAD) patients with anxiety and depression', 'CAD patients']","['IPEL', ""intensive patients' education and lifestyle improving program (IPEL"", 'control group only received usual care']","['anxiety, depression, and overall survival (OS', 'anxiety and depression and improves OS', 'OS', 'Hospital Anxiety and Depression Scale-anxiety (HADS-A) and HADS-depression (HADS-D', 'anxiety and depression', 'percentage of depression at M12 and HADS-D score', 'IPEL reduced HADS-A score', 'IPEL reduced HADS-D score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",224.0,0.0288189,"IPEL reduced HADS-D score at M12, and the percentage of depression at M12 and HADS-D score changed compared with control.","[{'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': '1 Department of Geriatrics, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Tianzhu', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': '2 Department of General Surgery, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': '3 Department of Nursing, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}]",Western journal of nursing research,['10.1177/0193945918810205']
1205,30467711,Effect of an Educational Video to Increase Calls and Screening into an Anal Cancer Clinical Trial Among HIV+ Hispanics in PR: Results from a Randomized Controlled Behavioral Trial.,"Anal cancer incidence is higher in persons living with HIV/AIDS (PLWHA) than in the general population. Participation of PLWHA in anal cancer clinical trials (CTs) is essential; Hispanic PLWHA are underrepresented in CTs. We conducted a behavioral CT among 305 PLWHA in Puerto Rico to measure the efficacy of an educational video in increasing calls and screening into an anal cancer CT. Participants received printed educational materials on anal cancer and CTs; the intervention group also received an educational video. Outcome assessment based on follow-up interviews showed that printed materials increased awareness about CTs and high-resolution anoscopy (HRA), and willingness to participate in an anal cancer CT in both groups. However, the addition of the video increased the likelihood of participants to call the CT for orientation (RR adjusted  = 1.66, 95% CI 1.00-2.76; p = 0.05) and pre-screening evaluation (RR adjusted  = 1.70, 95% CI 0.95-3.03; p = 0.07). This intervention could help increase participation of Hispanics into anal cancer-related CTs.",2019,"Outcome assessment based on follow-up interviews showed that printed materials increased awareness about CTs and high-resolution anoscopy (HRA), and willingness to participate in an anal cancer CT in both groups.","['persons living with HIV/AIDS (PLWHA) than in the general population', 'HIV+ Hispanics in PR']","['Educational Video', 'PLWHA', 'printed educational materials on anal cancer and CTs; the intervention group also received an educational video', 'educational video']","['awareness about CTs and high-resolution anoscopy (HRA), and willingness to participate in an anal cancer CT', 'Anal cancer incidence']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0279637', 'cui_str': 'Anal Cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0193158', 'cui_str': 'Anoscopy (procedure)'}, {'cui': 'C0279637', 'cui_str': 'Anal Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0288922,"Outcome assessment based on follow-up interviews showed that printed materials increased awareness about CTs and high-resolution anoscopy (HRA), and willingness to participate in an anal cancer CT in both groups.","[{'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Ortiz', 'Affiliation': 'Cancer Control and Population Sciences Program, University of Puerto Rico Comprehensive Cancer Center, San Juan, Puerto Rico. ana.ortiz7@upr.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Machin', 'Affiliation': 'Cancer Control and Population Sciences Program, University of Puerto Rico Comprehensive Cancer Center, San Juan, Puerto Rico.'}, {'ForeName': 'Marievelisse', 'Initials': 'M', 'LastName': 'Soto-Salgado', 'Affiliation': 'University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Hilmaris', 'Initials': 'H', 'LastName': 'Centeno-Girona', 'Affiliation': 'University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Darilyn', 'Initials': 'D', 'LastName': 'Rivera-Collazo', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'González', 'Affiliation': 'University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Moon S', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Cancer Control/Cancer Health Disparities, Division of Hematology and Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Colón-López', 'Affiliation': 'Cancer Control and Population Sciences Program, University of Puerto Rico Comprehensive Cancer Center, San Juan, Puerto Rico.'}]",AIDS and behavior,['10.1007/s10461-018-2330-z']
1206,30278853,A randomized controlled trial of working memory and processing speed training in schizophrenia.,"BACKGROUND


Although prior research has shown that cognitive training may improve cognition for schizophrenia patients, it is currently unclear which domains of cognition should be targeted in training. One suggestion is to target low- or mid-level cognitive processes. In particular, working memory (WM) and processing speed (PS) have been named as two key areas of impairment in schizophrenia, and two domains of cognition that are linked to higher-order cognition and daily functioning. This study aimed to investigate the near-transfer (transfer of gains to related contexts), far-transfer (transfer of gains to unrelated contexts), and real-world gains associated with WM and PS training in schizophrenia.
METHODS


Eighty-three participants with schizophrenia were recruited and randomly assigned to computerized WM training, PS training, or a no-training control group. Outcome measures included WM, PS, fluid intelligence, executive functioning, social cognition, and daily functioning and symptoms.
RESULTS


PS training led to significant gains in untrained PS tasks, as well as gains in far-transfer tasks that required speed of processing. WM training did not lead to gains in untrained WM tasks and showed inconsistent effects on some far-transfer tasks.
CONCLUSIONS


These results suggest some benefit of domain-specific cognitive training, specifically PS training, in schizophrenia. Far-transfer of gains to other cognitive domains and to real-world functioning may not occur after targeted WM or PS training, though non-specific effects (e.g. through behavioral activation, increased motivation) may lead to improvements in some tasks. Future studies should continue to investigate the mechanisms by which cognitive training may enhance cognition and functioning in schizophrenia.",2019,"WM training did not lead to gains in untrained WM tasks and showed inconsistent effects on some far-transfer tasks.
","['schizophrenia', 'Eighty-three participants with schizophrenia', 'schizophrenia patients']","['WM training', 'working memory and processing speed training', 'computerized WM training, PS training, or a no-training control group', 'cognitive training', 'working memory (WM) and processing speed (PS']","['WM, PS, fluid intelligence, executive functioning, social cognition, and daily functioning and symptoms', 'untrained PS tasks']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",83.0,0.0240582,"WM training did not lead to gains in untrained WM tasks and showed inconsistent effects on some far-transfer tasks.
","[{'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Cassetta', 'Affiliation': 'Department of Psychology, University of Calgary, 2500 University Drive NW, Calgary, AB, Canada, T2N 1N4.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Tomfohr-Madsen', 'Affiliation': 'Department of Psychology, University of Calgary, 2500 University Drive NW, Calgary, AB, Canada, T2N 1N4.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Goghari', 'Affiliation': 'Department of Psychology and Graduate Department of Psychological Clinical Science, University of Toronto Scarborough, 1265 Military Trail, Toronto, ON, Canada, M1C 1A4.'}]",Psychological medicine,['10.1017/S0033291718002775']
1207,31655073,Contraceptive counseling practices and patient experience: Results from a cluster randomized controlled trial at Planned Parenthood.,"OBJECTIVES


Systematic reviews of contraceptive counseling interventions have shown inconsistent impact on patient outcomes. The current study assessed the effects of an evidence-informed contraceptive counseling staff training intervention on patient experience, contraceptive selection, and behavior over three months of follow-up.
STUDY DESIGN


We randomly assigned 10 Planned Parenthood health centers in the Southeastern US to intervention (staff received contraceptive counseling training) and control (usual counseling) groups. From December 2016-June 2017, patients completed surveys immediately post visit (n = 756) and one and three months after. We compared differences in patients' counseling experience (e.g., number of evidence-informed practices experienced, satisfaction with counseling), contraceptive selection, and behavior (e.g., method discontinuation, accurate pill use, condom use) between study groups using mixed effect models with health center specified as a random effect.
RESULTS


Seven hundred and fifty-six participants completed the baseline survey; 579 (77%) completed one or both follow-up surveys. The intervention group was more likely to report experiencing all evidence-informed counseling practices (adj. Prevalence Ratio [aPR] = 2.27, 95% CI 1.27, 4.04) with less variation in the number of practices and higher satisfaction with their counseling than the control group (p < 0.01). We found no sustained differences in contraceptive behaviors at both one- and three-month follow-up.
CONCLUSIONS


We found immediate positive effects of the intervention on patients' perceptions of their counseling experience and no differences in changes in contraceptive behavior over time between the study groups.
IMPLICATIONS


Evidence-based strategies to improve the quality of contraceptive care and subsequent outcomes, while centering patients' needs and preferences, are needed. The contraceptive counseling intervention offers a tool for increasing consistency in contraceptive counseling practices across health centers and improving patient satisfaction.",2020,"We found immediate positive effects of the intervention on patients' perceptions of their counseling experience and no differences in changes in contraceptive behavior over time between the study groups.
","['Seven hundred and fifty-six participants completed the baseline survey; 579 (77%) completed one or both follow-up surveys', 'contraceptive counseling practices across health centers']","['contraceptive counseling interventions', 'evidence-informed contraceptive counseling staff training intervention', 'contraceptive counseling intervention', 'Contraceptive counseling practices', 'contraceptive counseling training) and control (usual counseling']","['contraceptive behaviors', 'Prevalence Ratio', 'contraceptive behavior', 'patient experience, contraceptive selection, and behavior']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0009862', 'cui_str': 'Contraceptive Behavior'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",756.0,0.1014,"We found immediate positive effects of the intervention on patients' perceptions of their counseling experience and no differences in changes in contraceptive behavior over time between the study groups.
","[{'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Simons', 'Affiliation': 'Planned Parenthood Federation of America, New York, NY, USA. Electronic address: hannah.simons@ppfa.org.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Leon-Atkins', 'Affiliation': 'Planned Parenthood Federation of America, New York, NY, USA.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Kohn', 'Affiliation': 'Planned Parenthood Federation of America, New York, NY, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Spector', 'Affiliation': 'Planned Parenthood South Atlantic, Raleigh, NC, USA.'}, {'ForeName': 'Jade F', 'Initials': 'JF', 'LastName': 'Hillery', 'Affiliation': 'Planned Parenthood Federation of America, New York, NY, USA.'}, {'ForeName': 'Gulielma', 'Initials': 'G', 'LastName': 'Fager', 'Affiliation': 'Planned Parenthood Federation of America, New York, NY, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Kantor', 'Affiliation': 'Planned Parenthood Federation of America, New York, NY, USA; Rutgers School of Public Health, Newark, NJ, USA.'}]",Contraception,['10.1016/j.contraception.2019.10.003']
1208,30296845,Outcomes of children receiving Group-Early Start Denver Model in an inclusive versus autism-specific setting: A pilot randomized controlled trial.,"A major topic of debate is whether children with autism spectrum disorder should be educated in inclusive or specialized settings. We examined the feasibility and preliminary effectiveness of delivering the Group-Early Start Denver Model to children with autism spectrum disorder in inclusive versus specialized classrooms. We randomly assigned 44 preschoolers with autism spectrum disorder to receive the Group-Early Start Denver Model across one school calendar year in classrooms that included only children with autism spectrum disorder or mostly children who were typically developing. Blind-rated indicators of teaching quality showed similar results across settings, which were above the local benchmark. Children showed improvements across blinded proximal measures of spontaneous vocalization, social interaction, and imitation and across distal measures of verbal cognition, adaptive behavior, and autism symptoms irrespective of intervention setting. Mothers of participants experienced a reduction in stress irrespective of child intervention setting. Across both settings, age at intervention start was negatively associated with gains in verbal cognition. Delivery of Group-Early Start Denver Model in an inclusive setting appeared to be feasible, with no significant differences in teaching quality and child improvements when the program was implemented in inclusive versus specialized classrooms.",2019,"Children showed improvements across blinded proximal measures of spontaneous vocalization, social interaction, and imitation and across distal measures of verbal cognition, adaptive behavior, and autism symptoms irrespective of intervention setting.","['in classrooms that included only children with autism spectrum disorder or mostly children who were typically developing', 'children with autism spectrum disorder', '44 preschoolers with autism spectrum disorder to', 'children with autism spectrum disorder in inclusive versus specialized classrooms', 'children receiving Group-Early Start Denver Model in an inclusive versus autism-specific setting']","['delivering the Group-Early Start Denver Model', 'receive the Group-Early Start Denver Model across one school calendar year']","['spontaneous vocalization, social interaction, and imitation and across distal measures of verbal cognition, adaptive behavior, and autism symptoms', 'teaching quality and child improvements', 'verbal cognition']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029039', 'cui_str': 'Only Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456586', 'cui_str': 'Calendar year (qualifier value)'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0564182', 'cui_str': 'Vocalizing'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",44.0,0.0488802,"Children showed improvements across blinded proximal measures of spontaneous vocalization, social interaction, and imitation and across distal measures of verbal cognition, adaptive behavior, and autism symptoms irrespective of intervention setting.","[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vivanti', 'Affiliation': '1 A.J. Drexel Autism Institute, Drexel University, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Dissanayake', 'Affiliation': '2 La Trobe University, Australia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Duncan', 'Affiliation': '2 La Trobe University, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Feary', 'Affiliation': '2 La Trobe University, Australia.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Capes', 'Affiliation': '2 La Trobe University, Australia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Upson', 'Affiliation': '2 La Trobe University, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Bent', 'Affiliation': '2 La Trobe University, Australia.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': '3 University of California, USA.'}, {'ForeName': 'Kristelle', 'Initials': 'K', 'LastName': 'Hudry', 'Affiliation': '2 La Trobe University, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Autism : the international journal of research and practice,['10.1177/1362361318801341']
1209,30309256,The Physiological Impact of Window Murals on Pediatric Patients.,"OBJECTIVES


To examine the magnitude of impact of two nature-themed window murals on physiological processes, as measured by heart rate and blood pressure, of pediatric patients.
BACKGROUND


Many children and adolescents find at least one aspect of the hospitalization process frightening or anxiety provoking. One physical feature linked to stress reduction is access to positive distractions. Views of nature are one of the most common forms of positive distractions in healthcare environments. Patient room windows are the most common way patients are exposed to natural elements. Exposure to views of nature is linked to a number of positive impacts on physiological outcomes. Unfortunately, not every patient room will be able to provide a nature-filled window view. In situations where nature scenes do not occur, enhanced nature views may be utilized to replicate many of the same benefits as actual nature views.
METHODS


Pediatric patients were randomly assigned to one of the three room conditions: aquatic window mural, tree window mural, or control condition. The medical data of participants ( n = 90) who stayed in the rooms were gathered and evaluated for differences.
RESULTS


Data analysis supports the notion that patient stress is heightened at the time of admission. Patients in the rooms with murals were found to have improvements in heart rate and systolic blood pressure in comparison to patients in control rooms, suggesting that the murals had an impact on physiological processes. Data also suggest that subject matter played a role, as patients in tree murals rooms had the most health-related outcomes.",2019,"Patients in the rooms with murals were found to have improvements in heart rate and systolic blood pressure in comparison to patients in control rooms, suggesting that the murals had an impact on physiological processes.","['Pediatric patients', 'pediatric patients', 'Pediatric Patients']","['aquatic window mural, tree window mural, or control condition']","['heart rate and blood pressure', 'heart rate and systolic blood pressure']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0441995', 'cui_str': 'Mural (qualifier value)'}, {'cui': 'C0040811', 'cui_str': 'Trees'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",90.0,0.0511364,"Patients in the rooms with murals were found to have improvements in heart rate and systolic blood pressure in comparison to patients in control rooms, suggesting that the murals had an impact on physiological processes.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': '1 Department of Design, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Gaines', 'Affiliation': '1 Department of Design, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Debajyoti', 'Initials': 'D', 'LastName': 'Pati', 'Affiliation': '1 Department of Design, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Malinda', 'Initials': 'M', 'LastName': 'Colwell', 'Affiliation': '2 Human Development and Family Studies, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Motheral', 'Affiliation': '3 General Pediatrics, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Nicole Gilinsky', 'Initials': 'NG', 'LastName': 'Adams', 'Affiliation': '4 Independent Consultant, Lubbock, TX, USA.'}]",HERD,['10.1177/1937586718800483']
1210,30325305,AVURT: aspirin versus placebo for the treatment of venous leg ulcers - a Phase II pilot randomised controlled trial.,"BACKGROUND


Venous leg ulcers (VLUs) are the most common cause of leg ulceration, affecting 1 in 100 adults. VLUs may take many months to heal (25% fail to heal). Estimated prevalence is between 1% and 3% of the elderly population. Compression is the mainstay of treatment and few additional therapies exist to improve healing. Two previous trials have indicated that low-dose aspirin, as an adjunct to standard care, may improve healing time, but these trials were insufficiently robust. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established.
OBJECTIVES


Primary objective - to assess the effects of 300 mg of aspirin (daily) versus placebo on the time to healing of the reference VLU. Secondary objectives - to assess the feasibility of leading into a larger pragmatic Phase III trial and the safety of aspirin in this population.
DESIGN


A multicentred, pilot, Phase II randomised double-blind, parallel-group, placebo-controlled efficacy trial.
SETTING


Community leg ulcer clinics or services, hospital outpatient clinics, leg ulcer clinics, tissue viability clinics and wound clinics in England, Wales and Scotland.
PARTICIPANTS


Patients aged ≥ 18 years with a chronic VLU (i.e. the VLU is > 6 weeks in duration or the patient has a history of VLU) and who are not regularly taking aspirin.
INTERVENTIONS


300 mg of daily oral aspirin versus placebo. All patients were offered care in accordance with Scottish Intercollegiate Guidelines Network (SIGN) guidance with multicomponent compression therapy aiming to deliver 40 mmHg at the ankle when possible.
RANDOMISATION


Participants were allocated in a 1 : 1 (aspirin : placebo) ratio by the Research Pharmacy, St George's University Hospitals NHS Foundation Trust, using a randomisation schedule generated in advance by the investigational medicinal product manufacturer. Randomisation was stratified according to ulcer size (≤ 5cm 2  or > 5cm 2 ).
MAIN OUTCOME MEASURE


The primary outcome was time to healing of the largest eligible ulcer (reference ulcer).
FEASIBILITY RESULTS – RECRUITMENT


27 patients were recruited from eight sites over a period of 8 months. The target of 100 patients was not achieved and two sites did not recruit. Barriers to recruitment included a short recruitment window and a large proportion of participants failing to meet the eligibility criteria.
RESULTS


The average age of the 27 randomised participants (placebo,  n  = 13; aspirin,  n  = 14) was 62 years (standard deviation 13 years), and two-thirds were male ( n  = 18). Participants had their reference ulcer for a median of 15 months, and the median size of ulcer was 17.1 cm 2 . There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85;  p  = 0.357). One expected, related serious adverse event was recorded for a participant in the aspirin group.
LIMITATIONS


The trial under-recruited because many patients did not meet the eligibility criteria.
CONCLUSIONS


There was no evidence that aspirin was efficacious in hastening the healing of chronic VLUs. It can be concluded that a larger Phase III (effectiveness) trial would not be feasible.
TRIAL REGISTRATION


Clinical Trials.gov NCT02333123; European Clinical Trials Database (EudraCT) 2014-003979-39.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 22, No. 55. See the NIHR Journals Library website for further project information.",2018,"There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85;  p  = 0.357).","['100 adults', 'venous leg ulcers ', '27 patients were recruited from eight sites over a period of 8 months', '100 patients was not achieved and two sites did not recruit', 'Patients aged ≥\u200918 years with a chronic VLU (i.e. the VLU is >\u20096 weeks in duration or the patient has a history of VLU) and who are not regularly taking aspirin', 'Community leg ulcer clinics or services, hospital outpatient clinics, leg ulcer clinics, tissue viability clinics and wound clinics in England, Wales and Scotland', 'All patients were offered care in accordance with Scottish Intercollegiate Guidelines Network (SIGN) guidance with', '  n \u2009=\u200914) was 62 years (standard deviation 13 years), and two-thirds were male ( n \u2009=\u200918']","['aspirin\u2009:\u2009placebo', 'aspirin', 'placebo', 'AVURT: aspirin versus placebo', 'Aspirin', 'aspirin (daily) versus placebo', 'placebo,  n \u2009=\u200913; aspirin', 'multicomponent compression therapy', 'aspirin versus placebo']","['time to healing of the reference VLU', 'serious adverse event', 'time to healing of the largest eligible ulcer (reference ulcer', 'time to healing of the reference ulcer', 'healing time', 'median size of ulcer']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0029916', 'cui_str': 'Ambulatory Care Facilities, Hospital'}, {'cui': 'C1449935', 'cui_str': 'Tissue Viability'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",27.0,0.208957,"There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85;  p  = 0.357).","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tilbrook', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bland', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Buckley', 'Affiliation': 'Cancer Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chetter', 'Affiliation': 'Academic Vascular Surgical Unit, Hull Royal Infirmary, Hull, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dumville', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fenner', 'Affiliation': 'Orthopaedic Department, West Middlesex Hospital, Isleworth, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Forsythe', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Hull York Medical School and York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Harding', 'Affiliation': 'Wound Healing, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Layton', 'Affiliation': 'Harrogate and District NHS Foundation Trust, Harrogate, UK.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Lindsay', 'Affiliation': 'The Lindsay Leg Club Foundation, Ipswich, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Moffatt', 'Affiliation': 'School of Health Sciences, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Rolfe', 'Affiliation': ""Joint Research and Enterprise Office, St George's University of London, London, UK.""}, {'ForeName': 'Illary', 'Initials': 'I', 'LastName': 'Sbizzera', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Stansby', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vowden', 'Affiliation': 'Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary, Bradford, UK.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'Lay representative.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hinchliffe', 'Affiliation': 'Bristol Centre for Surgical Research, National Institute for Health Research (NIHR) Biomedical Research Centre, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta22550']
1211,30251749,The Effect of Interfascial Injection on Obturator Nerve Block Compared with Nerve Stimulating Approach by Ultrasound-Guide: A Randomized Clinical Trial.,"PURPOSE


This study was conducted to evaluate whether the ultrasound-guided interfascial injection technique is really compatible with the ultrasound-guided nerve stimulating technique for obturator nerve block (ONB) at the inguinal crease after bifurcation of the obturator nerve.
MATERIALS AND METHODS


A total 62 ONBs were performed for transurethral resection of bladder tumors under spinal anesthesia, and divided into two groups, that is, to an ultrasound-guided ONB with nerve stimulation control group (the US-NS group) or an ultrasound-guided interfascial injection experimental group (the US-IFI group). In the US-IFI group, complete ONB was confirmed using a nerve stimulator at 5 min after completing the injection, and if residual twitching remained, another local anesthetic was injected; in such cases blocks were considered to have 'failed'. During TURB surgeries, two urology assistants determined obturator reflex grade (I-IV) at 15 min after injection completion in both groups.
RESULTS


We assumed that the US-NS group achieved complete ONB in all cases. Six cases in the US-IFI group failed to achieve complete ONB (failure rate: 0% versus 19.4%, P = .012). There was one case of grade II obturator reflex in each group.
CONCLUSION


The ultrasound-guided interfascial injection technique was not compatible with the ultrasound-guided nerve stimulating technique for ONB at the inguinal crease.",2019,The ultrasound-guided interfascial injection technique was not compatible with the ultrasound-guided nerve stimulating technique for ONB at the inguinal crease.,[],"['Interfascial Injection', 'transurethral resection of bladder tumors under spinal anesthesia', 'Nerve Stimulating Approach by Ultrasound-Guide', 'ultrasound-guided interfascial injection technique', 'ultrasound-guided ONB with nerve stimulation control group (the US-NS group) or an ultrasound-guided interfascial injection experimental group']","['grade II obturator reflex', 'complete ONB (failure rate', 'complete ONB']",[],"[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0449623', 'cui_str': 'Nerve stimulated (attribute)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",62.0,0.0215325,The ultrasound-guided interfascial injection technique was not compatible with the ultrasound-guided nerve stimulating technique for ONB at the inguinal crease.,"[{'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea. fred0314@gilhospital.com.'}, {'ForeName': 'Hee Yeon', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kyung Mi', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Hyeon Ju', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Su Bin', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Mi Geum', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}]",Urology journal,['10.22037/uj.v0i0.4386']
1212,31870562,"Effect of a 6-week ""Mediterranean"" dietary intervention on in vitro human embryo development: the Preconception Dietary Supplements in Assisted Reproduction double-blinded randomized controlled trial.","OBJECTIVE


To study the impact of increased dietary intake of omega-3 fatty acids, vitamin D, and olive oil for 6 weeks before in vitro fertilization (IVF) or IVF-intracytoplasmic sperm injection (ICSI) on morphokinetic markers of early embryo development.
DESIGN


A double-blinded randomized controlled trial.
SETTING


Academic IVF unit.
PATIENT(S)


A total of 111 couples undergoing IVF or IVF-ICSI were recruited.
INTERVENTIONS(S)


Fifty-five couples received the 6-week study intervention of a daily supplement drink enriched with omega-3 fatty acids and vitamin D plus additional olive oil and olive oil-based spread, and 56 couples received the control intervention.
MAIN OUTCOME MEASURE(S)


The primary end point for the study was the time taken for completion of the second cell cycle after fertilization (CC2). Secondary end points included time to complete the third and fourth cell cycles (CC3 and CC4), the synchrony of the second and third cell cycles (S2 and S3), and the day 3 and day 5 Known Implantation Data Scores (KIDScores).
RESULT(S)


There was no difference in CC2 between the two groups. However, CC4 was accelerated in the study group compared with the control group, and a significantly shortened S3 as well as an increase in KIDScore on day 3 were observed, indicating improved embryo quality in the study group.
CONCLUSION(S)


This study demonstrates that a short period of dietary supplementation alters the rate of embryo cleavage. Further research is required to investigate the mechanisms that regulate this effect, and whether the impact on embryo development translates into improved clinical outcomes.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN50956936.",2020,There was no difference in CC2 between the two groups.,"['111 couples undergoing IVF or IVF-ICSI were recruited', 'Academic IVF unit in the United Kingdom', '\n\n\nFifty-five couples']","['Preconception Dietary Supplements', 'omega-3 fatty acids, vitamin D, and olive oil', 'daily supplement drink enriched with omega-3 fatty acids and vitamin D plus additional olive oil and olive oil-based spread, and 56 couples received the control intervention', 'IVF-intracytoplasmic sperm injection (ICSI', 'dietary supplementation', 'Mediterranean"" dietary intervention']","['time to complete the third and fourth cell cycles (CC3 and CC4), the synchrony of the second and third cell cycles (S2 and S3), and the day 3 and day 5 Known Implantation Data Scores (KIDScores', 'CC2', 'embryo quality', 'vitro human\xa0embryo development', 'CC4', 'rate of embryo cleavage', 'time taken for completion of the second cell cycle after fertilization (CC2']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0007586', 'cui_str': 'Cell Division Cycle'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0013936', 'cui_str': 'Embryonic Development'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}]",55.0,0.509738,There was no difference in CC2 between the two groups.,"[{'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Kermack', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom; Centre for Human Development, Stem Cells and Regeneration, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; Complete Fertility Centre, Department of Obstetrics and Gynaecology, Princess Anne Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom. Electronic address: alexandra.kermack@uhs.nhs.uk.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Lowen', 'Affiliation': 'Complete Fertility Centre, Department of Obstetrics and Gynaecology, Princess Anne Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Wellstead', 'Affiliation': 'Complete Fertility Centre, Department of Obstetrics and Gynaecology, Princess Anne Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'Centre for Human Development, Stem Cells and Regeneration, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Montag', 'Affiliation': 'Ilabcomm, St. Augustin, Germany.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom; Centre for Human Development, Stem Cells and Regeneration, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; Complete Fertility Centre, Department of Obstetrics and Gynaecology, Princess Anne Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Osmond', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Franchesca D', 'Initials': 'FD', 'LastName': 'Houghton', 'Affiliation': 'Centre for Human Development, Stem Cells and Regeneration, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom; Centre for Human Development, Stem Cells and Regeneration, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Nick S', 'Initials': 'NS', 'LastName': 'Macklon', 'Affiliation': ""NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom; Centre for Human Development, Stem Cells and Regeneration, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; Complete Fertility Centre, Department of Obstetrics and Gynaecology, Princess Anne Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Reprohealth, Zealand University Hospital, Roskilde, Denmark; London Women's Clinic, London, United Kingdom.""}]",Fertility and sterility,['10.1016/j.fertnstert.2019.09.041']
1213,31611341,Risk factors for disease progression in idiopathic pulmonary fibrosis.,"In this retrospective study of a randomised trial of simtuzumab in idiopathic pulmonary fibrosis (IPF), prodromal decline in forced vital capacity (FVC) was significantly associated with increased risk of mortality, respiratory and all-cause hospitalisations, and categorical disease progression. Predictive modelling of progression-free survival event risk was used to assess the effect of population enrichment for patients at risk of rapid progression of IPF; C-index values were 0.64 (death), 0.69 (disease progression), and 0.72 (adjudicated respiratory hospitalisation) and 0.76 (all-cause hospitalisation). Predictive modelling may be a useful tool for improving efficiency of clinical trials with categorical end points.",2020,Predictive modelling may be a useful tool for improving efficiency of clinical trials with categorical end points.,"['patients at risk of rapid progression of IPF; C-index values were 0.64 (death), 0.69 (disease progression), and 0.72 (adjudicated respiratory hospitalisation) and 0.76 (all-cause hospitalisation', 'idiopathic pulmonary fibrosis']",['simtuzumab'],"['idiopathic pulmonary fibrosis (IPF), prodromal decline in forced vital capacity (FVC', 'risk of mortality, respiratory and all-cause hospitalisations, and categorical disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517470', 'cui_str': 'Zero point six four'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C4517475', 'cui_str': '0.72'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C4054022', 'cui_str': 'simtuzumab'}]","[{'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",,0.0320595,Predictive modelling may be a useful tool for improving efficiency of clinical trials with categorical end points.,"[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'Center for Interstitial Lung Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA graghu@uw.edu.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Ley', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, National Jewish Health, Denver, Colorado, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Center for Rare Pulmonary Diseases, Hospices Civils de Lyon, University of Lyon, UMR754, Lyon, France.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Gibson', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kaner', 'Affiliation': 'Department of Clinical Medicine and Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Noble', 'Affiliation': 'Department of Medicine, Cedars Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Song', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, National Heart & Lung Institute, Royal Brompton Hospital, Imperial College, London, UK.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Whelan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lynch', 'Affiliation': 'Department of Radiology, National Jewish Health, Denver, Colorado, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Humphries', 'Affiliation': 'Department of Radiology, National Jewish Health, Denver, Colorado, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Moreau', 'Affiliation': 'Research and Development, bioMérieux, Lyon, France.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Goodman', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Patterson', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Smith', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': 'Biostatistics, Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sundy', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': ""O'Riordan"", 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Medicine, Cornell University, New York City, New York, USA.'}]",Thorax,['10.1136/thoraxjnl-2019-213620']
1214,31650270,"Fifteen-year results of a randomized controlled trial comparing 0.02% mitomycin C, limbal conjunctival autograft, and combined mitomycin C with limbal conjunctival autograft in recurrent pterygium surgery.","PURPOSE


To compare the long-term outcomes of recurrent pterygium surgery between three different techniques.
METHODS


We performed a 15-year follow-up study of a randomized controlled study on surgical management of recurrent pterygium. Group 1 received limbal conjunctival autograft (LCAU); group 2 received intraoperative mitomycin C (MMC) 0.02% for 5 min; and group 3 received combined LCAU + MMC 0.02% for 5 min. Consecutive patients enrolled in the original study (from April 2001 to March 2003) were invited back for a detailed clinical examination to document the long-term outcomes. The main outcome measures included the recurrence rate, residual conjunctival bed status, and complications from any of the surgical methods.
RESULTS


Sixty-two patients were recruited in the original study. Eight patients had passed away and 12 patients were uncontactable or not responded. One patient who had bilateral operations refused to return for follow-up and one eye had insufficient data for analysis. Finally, 40 eyes of 40 patients were included for analyses. One eye developed a recurrence over 15 years and none required a tertiary pterygium operation. The patient received LCAU for a temporal recurrent pterygium developed a 2.2-mm recurrence.
CONCLUSIONS


All three techniques yielded favorable outcomes for patients with recurrent pterygium. The use of LCAU was associated with better cosmetic outcome.",2019,"The main outcome measures included the recurrence rate, residual conjunctival bed status, and complications from any of the surgical methods.
","['Consecutive patients enrolled in the original study (from April 2001 to March 2003', 'recurrent pterygium', 'recurrent pterygium surgery', 'Sixty-two patients were recruited in the original study', '40 eyes of 40 patients were included for analyses', 'Eight patients had passed away and 12 patients were uncontactable or not responded', 'patients with recurrent pterygium']","['mitomycin C, limbal conjunctival autograft, and combined mitomycin C with limbal conjunctival autograft', 'intraoperative mitomycin C (MMC', 'limbal conjunctival autograft (LCAU', 'LCAU', 'combined LCAU + MMC']","['recurrent pterygium surgery', 'recurrence rate, residual conjunctival bed status, and complications from any of the surgical methods']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0155158', 'cui_str': 'Recurrent pterygium (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]","[{'cui': 'C0155158', 'cui_str': 'Recurrent pterygium (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",62.0,0.106666,"The main outcome measures included the recurrence rate, residual conjunctival bed status, and complications from any of the surgical methods.
","[{'ForeName': 'Ka Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, Prince of Wales Hospital, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, Prince of Wales Hospital, Shatin, New Territories, Hong Kong. youngla@ha.org.hk.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-019-04499-5']
1215,31648204,Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease.,"BACKGROUND


Parkinson's disease (PD) results in a global decrease in information processing, ultimately resulting in dysfunction executing motor-cognitive tasks. Motor-cognitive impairments contribute to postural instability, often leading to falls and decreased physical activity. The aim of this study was to determine the effects of a multimodal training (MMT) versus single-modal (SMT) training on motor symptoms, fall frequency, and physical activity in patients with PD classified as fallers.
METHODS


Individuals with PD were randomized into SMT (n = 11) or MMT (n = 10) and completed training 3 times per week for 8 weeks. The SMT completed gait and cognitive training separately, whereas MMT completed gait and cognitive training simultaneously during each 45-minute session. Physical activity, 30-day fall frequency, and PD motor symptoms were assessed at baseline, posttreatment, and during a 4-week follow-up.
RESULTS


Both groups exhibited significant (P < .05) improvements in clinical ratings of motor function, as symptoms improved by 8% and 15% for SMT and MMT, respectively. Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]). The MMT resulted in a significant 60% reduction in falls.
CONCLUSIONS


Although SMT and MMT approaches are both effective in improving physical activity and motor symptoms of PD, only MMT reduced fall frequency after the intervention.",2019,Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]).,"[""Individuals With Parkinson's Disease"", 'patients with PD classified as fallers', 'Individuals with PD']","['multimodal training (MMT) versus single-modal (SMT) training', 'MMT', 'Multimodal Training', 'SMT']","['clinical ratings of motor function', 'falls', 'physical activity and motor symptoms of PD', 'motor symptoms, fall frequency, and physical activity', 'Physical activity', 'Physical activity, 30-day fall frequency, and PD motor symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0165732,Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]).,"[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Penko', 'Affiliation': ''}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Barkley', 'Affiliation': ''}, {'ForeName': 'Anson B', 'Initials': 'AB', 'LastName': 'Rosenfeldt', 'Affiliation': ''}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0595']
1216,30198318,"Effects of Heart Rate Reduction With Either Pyridostigmine or Ivabradine in Patients With Heart Failure: A Randomized, Double-Blind Study.","BACKGROUND


Heart rate (HR) reduction with ivabradine has been proved to reduce hospitalization and death from heart failure (HF). We sought to investigate whether pyridostigmine would effectively reduce HR in patients with chronic HF as compared with ivabradine.
METHODS


Twenty-one patients with HF who were in sinus rhythm with a resting HR over 70 bpm, despite optimal medical treatment, were included in a randomized, double-blind study comparing pyridostigmine versus ivabradine. The initial dose of ivabradine was 5 mg twice daily to reach a target HR between 50 and 60 bpm and could be titrated to a maximum of 7.5 mg twice daily. Pyridostigmine was used in a fixed dose of 30 mg 3 times daily.
RESULTS


The baseline HR for ivabradine and pyridostigmine groups was 89.1 (13.5) and 80.1 (7.2) bpm, respectively ( P  = .083). After 6 months of treatment, HR was significantly reduced to 64.8 (8.3) bpm in the ivabradine group ( P  = .0014) and 63.6 (5.9) bpm in the pyridostigmine group ( P  = .0001). The N-terminal pro-B-type natriuretic peptide was reduced in the ivabradine group (median: 1308.4 [interquartile range: 731-1896] vs 755.8 [134.5-1014] pg/mL;  P  = .027) and in the pyridostigmine group (132.8 [89.9-829] vs 100.7 [38-360] pg/mL;  P  = .002). Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups. Exercise capacity was improved in both groups, with increments in volume of oxygen utilization ( V ˙ O 2 ; ivabradine: 13.1 vs 15.6,  P  = .048; pyridostigmine: 13.3 vs 16.7,  P  = .032). Heart rate recovery in the first minute postexercise was improved with pyridostigmine (11.8 [3.9] vs 18 [6.5];  P  = .046), but not with ivabradine (13.3 [6.9] vs 14.1 [8.2];  P  = .70). No differences in either group were observed in the myocardial scintigraphy with 123-iodine-metaiodobenzylguanidine.
CONCLUSION


Both drugs significantly reduced HR, with improvements in exercise capacity and in neurohormonal and inflammatory profiles.",2019,"Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups.","['Patients With Heart Failure', 'Twenty-one patients with HF who were in sinus rhythm with a resting HR over 70 bpm, despite optimal medical treatment', 'patients with chronic HF as compared with ivabradine']","['ivabradine', 'Pyridostigmine or Ivabradine', 'pyridostigmine', 'pyridostigmine versus ivabradine', 'Pyridostigmine']","['Heart Rate Reduction', 'volume of oxygen utilization', 'HR', 'Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor', 'Heart rate recovery', 'exercise capacity and in neurohormonal and inflammatory profiles', 'Exercise capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",21.0,0.262683,"Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups.","[{'ForeName': 'Aline Sterque', 'Initials': 'AS', 'LastName': 'Villacorta', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Villacorta', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'José Antônio', 'Initials': 'JA', 'LastName': 'Caldas', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bernardo Campanário', 'Initials': 'BC', 'LastName': 'Precht', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pilar Barreto', 'Initials': 'PB', 'LastName': 'Porto', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Letícia Ubaldo', 'Initials': 'LU', 'LastName': 'Rodrigues', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Neves', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Analucia Rampazzo', 'Initials': 'AR', 'LastName': 'Xavier', 'Affiliation': 'Pathology Department, LAMAP, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Kanaan', 'Affiliation': 'Pathology Department, LAMAP, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Cláudio Tinoco', 'Initials': 'CT', 'LastName': 'Mesquita', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Antônio Cláudio Lucas', 'Initials': 'ACL', 'LastName': 'da Nóbrega', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248418799364']
1217,30178449,Are Stone Density and Location Useful Parameters That Can Determine the Endourological Surgical Technique for Kidney Stones That are Smaller than 2 cm? A Prospective Randomized Controlled Trial.,"Purpose: We aimed to evaluate whether these parameters could be guiding for us in selection between retrograde intrarenal surgery (RIRS) and mini-percutaneous nephrolithotomy (PNL) procedures in kidney stones that are smaller than 2 cm.
MATERIALS AND METHODS


The patients who had kidney stones smaller than two cm and were planned to undergo surgery were randomly distributed into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while mini-PNL group was dilated up to 16.5F and mini-PNL was per-formed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of Hounsfield unit (HU) value indicating the stone density being higher or lower than 677 and stone location on stone-free rates.
RESULTS


The study involved 60 patients including 30 in each group. The groups' preoperative values were similar. The hospitalization time and the total duration of scopy were longer in mini-PNL when the postoperative values were compared (P < .0001). In terms of stone densities, HU values that were lower than 677 in the mini-PNL group affected the stone-free rate and reduced it from 100% (> 677HU) to 55.6% (< 677HU), whereas the change was significant (P = .005). Lower calyx stones affected the RIRS results negatively, whereas multiple calyceal stones affected the mini-PNL group negatively.
CONCLUSION


Both methods had a similar success rate, but lower pole stones, multiple calyceal stones and stone density parameters affected the stone-free rates significantly, and these may be effective in treatment selection.",2019,"Both methods had a similar success rate, but lower pole stones, multiple calyceal stones and stone density parameters affected the stone-free rates significantly, and these may be effective in treatment selection.","['60 patients including 30 in each group', 'Kidney Stones', 'patients who had kidney stones smaller than two cm and were planned to undergo surgery']",['retrograde intrarenal surgery (RIRS) and mini-percutaneous nephrolithotomy (PNL) procedures'],"['stone densities, HU values', 'multiple calyceal stones', 'stone-free rate', 'hospitalization time and the total duration of scopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",60.0,0.02222,"Both methods had a similar success rate, but lower pole stones, multiple calyceal stones and stone density parameters affected the stone-free rates significantly, and these may be effective in treatment selection.","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Gucuk', 'Affiliation': 'Department of Urology, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey. gucukadnan@hotmail.com.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Urology, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey.'}, {'ForeName': 'Sebahat', 'Initials': 'S', 'LastName': 'Gucuk', 'Affiliation': 'Department of Family Medicine, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Uyeturk', 'Affiliation': 'Department of Urology, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4280']
1218,30265610,"Epacadostat Plus Pembrolizumab in Patients With Advanced Solid Tumors: Phase I Results From a Multicenter, Open-Label Phase I/II Trial (ECHO-202/KEYNOTE-037).","PURPOSE


Tumors may evade immunosurveillance through upregulation of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme. Epacadostat is a potent and highly selective IDO1 enzyme inhibitor. The open-label phase I/II ECHO-202/KEYNOTE-037 trial evaluated epacadostat plus pembrolizumab, a programmed death protein 1 inhibitor, in patients with advanced solid tumors. Phase I results on maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics are reported.
PATIENTS AND METHODS


Patients received escalating doses of oral epacadostat (25, 50, 100, or 300 mg) twice per day plus intravenous pembrolizumab 2 mg/kg or 200 mg every 3 weeks. During the safety expansion, patients received epacadostat (50, 100, or 300 mg) twice per day plus pembrolizumab 200 mg every 3 weeks.
RESULTS


Sixty-two patients were enrolled and received one or more doses of study treatment. The maximum tolerated dose of epacadostat in combination with pembrolizumab was not reached. Fifty-two patients (84%) experienced treatment-related adverse events (TRAEs), with fatigue (36%), rash (36%), arthralgia (24%), pruritus (23%), and nausea (21%) occurring in ≥ 20%. Grade 3/4 TRAEs were reported in 24% of patients. Seven patients (11%) discontinued study treatment because of TRAEs. No TRAEs led to death. Epacadostat 100 mg twice per day plus pembrolizumab 200 mg every 3 weeks was recommended for phase II evaluation. Objective responses (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) occurred in 12 (55%) of 22 patients with melanoma and in patients with non-small-cell lung cancer, renal cell carcinoma, endometrial adenocarcinoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck. The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
CONCLUSION


Epacadostat in combination with pembrolizumab generally was well tolerated and had encouraging antitumor activity in multiple advanced solid tumors.",2018,"The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
","['22 patients with melanoma and in patients with non-small-cell lung cancer, renal cell carcinoma, endometrial adenocarcinoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck', 'patients with advanced solid tumors', 'Patients received', 'Solid Tumors', 'Patients With Advanced Solid Tumors', 'Sixty-two patients were enrolled and received one or more doses of study treatment']","['Open-Label', 'escalating doses of oral epacadostat', 'Epacadostat 100 mg twice per day plus pembrolizumab', 'Epacadostat Plus Pembrolizumab', 'pembrolizumab']","['pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate', 'pruritus', 'arthralgia', 'Grade 3/4 TRAEs', 'antitumor activity', 'maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics', 'treatment-related adverse events (TRAEs), with fatigue', 'nausea', 'rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1153706', 'cui_str': 'Adenocarcinoma of uterus (disorder)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",62.0,0.0502529,"The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
","[{'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mitchell', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Smith', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bauer', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wasser', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Olszanski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Luke', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Ani S', 'Initials': 'AS', 'LastName': 'Balmanoukian', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Emmett V', 'Initials': 'EV', 'LastName': 'Schmidt', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Yufan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Maleski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Leopold', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.78.9602']
1219,30104114,Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine.,"BACKGROUND


A newly developed bovine-human reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was tested for its potential effect on the immunogenicity of concomitantly administered EPI vaccines in infants in a randomized controlled study in India.
METHODS


In this Phase III, multicenter, open label, randomized, controlled study, three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given to healthy infants at 6, 10, and 14 weeks of age. Subjects also received three doses of DTwP-HepB-Hib (diphtheria, tetanus, whole-cell pertussis, hepatitis B, and haemophilus influenzae type b conjugate - pentavalent vaccine) and oral polio vaccine concomitantly at 6, 10, and 14 weeks of age and a single dose of inactivated polio vaccine at 14 weeks of age. Blood samples were collected four weeks after the final vaccination to assess immune responses to all the vaccines administered. For diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 antibodies, non-interference was to be supported if the lower limit of the two-sided 90% confidence interval (CI) for the seroprotection rate difference for the BRV-PV group minus the Rotarix® group was >10.0%. For pertussis antibodies, non-interference was to be supported if the lower limit of the two-sided 90% CI for the ratio of geometric mean concentrations (GMCs) was >0.5.
RESULTS


A total of 1500 infants were randomized to either BRV-PV (1125 infants) or Rotarix® (375 infants), of which 1341 completed the study as per the protocol. More than 97% of subjects achieved seroprotective antibody titres against diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 in both groups. The difference in seroprotection rates between the BRV-PV group and the Rotarix® group for all these antibodies was less than 1%. The ratio of GMCs of anti-pertussis IgG concentrations for the BRV-PV group versus Rotarix® was 1.04 [90% CI: 0.90; 1.19].
CONCLUSION


BRV-PV does not interfere with the immunogenicity of concomitantly administered routine infants vaccines.",2018,"More than 97% of subjects achieved seroprotective antibody titres against diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 in both groups.","['healthy infants at 6, 10, and 14\u202fweeks of age', '1500 infants']","['placebo', 'BRV-PV', 'BRV-PV or two doses of Rotarix®', 'Rotarix®', 'DTwP-HepB-Hib (diphtheria, tetanus, whole-cell pertussis, hepatitis B, and haemophilus influenzae type b conjugate - pentavalent vaccine) and oral polio vaccine', 'EPI vaccines']","['seroprotective antibody titres against diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type', 'ratio of GMCs of anti-pertussis IgG concentrations', 'seroprotection rates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0061073', 'cui_str': 'HPhCA'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}]","[{'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1328638', 'cui_str': 'Pertussis IgG'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",1500.0,0.174426,"More than 97% of subjects achieved seroprotective antibody titres against diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 in both groups.","[{'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Rathi', 'Affiliation': 'PATH, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kawade', 'Affiliation': 'Vadu Rural Health Program KEM Hospital Research Centre Vadu, Pune, India.'}, {'ForeName': 'Padmasani', 'Initials': 'P', 'LastName': 'Venkatramanan', 'Affiliation': 'Sri Ramachandra Medical Centre, Chennai, India.'}, {'ForeName': 'Ritabrata', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Lalwani', 'Affiliation': 'Bharati Vidyapeeth Medical College & Hospital, Pune, India.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Dubey', 'Affiliation': 'Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Venkateswara Rao', 'Affiliation': 'Gandhi Medical College & Gandhi Hospital, Secunderabad, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Narayanappa', 'Affiliation': 'JSS Medical College & Hospital, Mysore, India.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Ghildiyal', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Nithya J', 'Initials': 'NJ', 'LastName': 'Gogtay', 'Affiliation': 'Seth GS Medical College & KEM Hospital, Mumbai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Venugopal', 'Affiliation': 'Andhra Medical College, Visakhapatnam, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Palkar', 'Affiliation': 'Bharati Vidyapeeth Medical College & Hospital, Pune, India.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Munshi', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bavdekar', 'Affiliation': 'Vadu Rural Health Program KEM Hospital Research Centre Vadu, Pune, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Juvekar', 'Affiliation': 'Vadu Rural Health Program KEM Hospital Research Centre Vadu, Pune, India.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Ganguly', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'Prabal', 'Initials': 'P', 'LastName': 'Niyogi', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'Kheya Ghosh', 'Initials': 'KG', 'LastName': 'Uttam', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Kondekar', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Kumbhar', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Smilu', 'Initials': 'S', 'LastName': 'Mohanlal', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Mukesh C', 'Initials': 'MC', 'LastName': 'Agarwal', 'Affiliation': 'Seth GS Medical College & KEM Hospital, Mumbai, India.'}, {'ForeName': 'Parvan', 'Initials': 'P', 'LastName': 'Shetty', 'Affiliation': 'Seth GS Medical College & KEM Hospital, Mumbai, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Antony', 'Affiliation': 'PATH, India.'}, {'ForeName': 'Bhagwat', 'Initials': 'B', 'LastName': 'Gunale', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Dharmadhikari', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Deshpande', 'Affiliation': 'Enterovirus Research Centre, Mumbai, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nalavade', 'Affiliation': 'Enterovirus Research Centre, Mumbai, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Enterovirus Research Centre, Mumbai, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Quest Diagnostics India Private Limited, Gurgaon, India.'}, {'ForeName': 'Yuxiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'PATH, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, USA.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Kulkarni', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India. Electronic address: drpsk@seruminstitute.com.'}]",Vaccine,['10.1016/j.vaccine.2018.07.064']
1220,30160510,Race analysis in an African American sample with serious mental illness and comorbid diabetes.,"OBJECTIVES


Targeted Training in Illness Management (TTIM) focuses on enhancing care engagement for people living with serious mental illness and diabetes. This secondary analysis from a 60-week, randomized controlled trial of TTIM versus treatment as usual evaluated racial subgroup outcomes.
METHOD


Demographics, clinical characteristics, and diabetes status were evaluated for those self-identifying as non-Hispanic White, African American, and Hispanic. Longitudinal response to TTIM was evaluated using a multiple domain risk index. Due to their small sample size; those identifying as Hispanic were excluded from this analysis.
RESULTS


Non-Hispanic White participants had greater baseline socioeconomic advantages. Baseline risk scores, glycosylated hemoglobin (HbA1c) values, and HbA1c differences over time were similar for African American and non-Hispanic White participants.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


African American participants living with serious mental illness and diabetes receiving TTIM did as well as non-Hispanic White participants. Inclusive approaches that feature peer support and are situated in safety-net health care settings need to be further investigated with respect to potentially impacting health disparities. (PsycINFO Database Record",2018,"Baseline risk scores, glycosylated hemoglobin (HbA1c) values, and HbA1c differences over time were similar for African American and non-Hispanic White participants.
","['people living with serious mental illness and diabetes', 'African American participants living with serious mental illness and diabetes receiving TTIM did as well as non-Hispanic White participants', 'Hispanic White participants had greater baseline socioeconomic advantages', 'African American sample with serious mental illness and comorbid diabetes']",['TTIM'],"['Baseline risk scores, glycosylated hemoglobin (HbA1c) values, and HbA1c differences over time']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0535563,"Baseline risk scores, glycosylated hemoglobin (HbA1c) values, and HbA1c differences over time were similar for African American and non-Hispanic White participants.
","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Neurological and Behavioral Outcomes Center, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Howland', 'Affiliation': 'Neurological and Behavioral Outcomes Center, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Gunzler', 'Affiliation': 'Center for Health Care Research and Policy, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Stephanie W', 'Initials': 'SW', 'LastName': 'Kanuch', 'Affiliation': 'MetroHealth Medical Cente.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Cassidy', 'Affiliation': 'University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McCormick', 'Affiliation': 'Center for Health Care Research and Policy, Case Western Reserve University.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, Harvard Medical School.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Scheidemantel', 'Affiliation': 'Scheidemantel, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'MetroHealth Medical Center.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Blixen', 'Affiliation': 'Neurological and Behavioral Outcomes Center, Case Western Reserve University.'}, {'ForeName': 'Neal V', 'Initials': 'NV', 'LastName': 'Dawson', 'Affiliation': 'Center for Health Care Research and Policy, Case Western Reserve University School of Medicine.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000314']
1221,31862828,Comment on Jakubowicz et al. Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. Diabetes Care 2019;42:2171-2180.,,2020,,"['Diabetes', 'Patients With Type']",[],['Glycated Hemoglobin and Daily Insulin Dose'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.0233596,,"[{'ForeName': 'Ivan E', 'Initials': 'IE', 'LastName': 'Saraiva', 'Affiliation': 'Division of Hospital Medicine, University of Kentucky, Lexington, KY ivansaraiva@uky.edu.'}]",Diabetes care,['10.2337/dc19-1957']
1222,31862829,Response to Comment on Jakubowicz et al. Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. Diabetes Care 2019;42:2171-2180.,,2020,,"['Diabetes', 'Patients With Type']",[],['Glycated Hemoglobin and Daily Insulin Dose'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.0217909,,"[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Froy', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel oren.froy@mail.huji.ac.il.'}]",Diabetes care,['10.2337/dci19-0061']
1223,31898756,Nasolabial fold correction through cheek volume loss restoration versus thread lifting: a comparative study.,"Nasolabial folds are caused by loss of deep fat and subsequent loss of muscle contour in the midface, leading to sagging which forms cosmetic issues in some cases when they are otherwise overly pronounced. Various treatment procedures have been developed to reduce their appearance. The objective of this study is to compare the efficacy of hyaluronic acid (HA) cheek fillers injection and thread lifting in improving the nasolabail folds. Twenty cases presenting with prominent nasolabial folds were randomly divided into two groups; group A underwent HA fillers for cheek lifting and group B underwent thread lifting for the cheek. Only one session was done for each case, and then they were followed up after 1 and 2 months. Statistical significant difference after treatment for both groups was detected using the wrinkle severity rating scale (WSRS) and the modified Fitzpatrick wrinkle scale (MFWS). The average global aesthetic improvement scale (GAIS) was 2.2 ± 0.79 for the fillers group and 3.2 ± 0.92 for the threads group, showing a statistical significant improvement with a p value less than 0.05 favoring the fillers group. 70% of fillers cases were satisfied and only 30% of threads cases. Fillers cheek injection is recommended for patients with sagged thin face to improve the nasolabial folds as well as giving volume and contour. Threads would do better for patients desiring an oval, less wide face shape. Combining threads with other cosmetic procedure would give a better holistic appearance.",2020,"The average global aesthetic improvement scale (GAIS) was 2.2 ± 0.79 for the fillers group and 3.2 ± 0.92 for the threads group, showing a statistical significant improvement with a p value less than 0.05 favoring the fillers group.","['Twenty cases presenting with prominent nasolabial folds', 'patients with sagged thin face']","['Nasolabial fold correction through cheek volume loss restoration versus thread lifting', 'HA fillers', 'hyaluronic acid (HA) cheek fillers injection']","['wrinkle severity rating scale (WSRS) and the modified Fitzpatrick wrinkle scale (MFWS', 'average global aesthetic improvement scale (GAIS']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205402', 'cui_str': 'Prominent (qualifier value)'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial Fold'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0221328', 'cui_str': 'Nasolabial Fold'}, {'cui': 'C0007966', 'cui_str': 'Bucca'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0206244', 'cui_str': 'Lifting'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}]",,0.0111716,"The average global aesthetic improvement scale (GAIS) was 2.2 ± 0.79 for the fillers group and 3.2 ± 0.92 for the threads group, showing a statistical significant improvement with a p value less than 0.05 favoring the fillers group.","[{'ForeName': 'Marwa S', 'Initials': 'MS', 'LastName': 'El-Mesidy', 'Affiliation': 'Dermatology Department, Kasr Al Ainy Faculty of Medicine Cairo University, Cairo, Egypt. Marwa.elmesidy@kasralainy.edu.eg.'}, {'ForeName': 'Waseem T', 'Initials': 'WT', 'LastName': 'Alaklouk', 'Affiliation': 'Dermatology Department, Kasr Al Ainy Faculty of Medicine Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Azzam', 'Affiliation': 'Dermatology Department, Kasr Al Ainy Faculty of Medicine Cairo University, Cairo, Egypt.'}]",Archives of dermatological research,['10.1007/s00403-019-02031-7']
1224,30058061,Comparison of the Efficacy of Intravenous and Intramuscular Lornoxicam for the Initial Treatment of Acute Renal Colic: A Randomized Clinical Trial.,"PURPOSE


We aimed to find out if there was any difference between intramuscular and intravenous administration of lornoxicam in terms of efficacy and side effects.
MATERIALS AND METHODS


This study was a single-blind parallel-group randomized clinical trial. A total of 51 patients who were diagnosed with acute renal colic at our clinic were included in the study. Pain severity prior to treatment was rated using the Visual Analogue Scale (VAS). Patients were randomized into 2 groups: Group 1 (n = 27) received intramuscular 8mg lornoxicam and Group 2 (n=24) received intravenous 8mg lornoxicam. Pain severity was reassessed 30 minutes after the treatment. Pre- and post-treatment VAS scores and the mean changein the VAS scores of the 2 groups were statistically compared.
RESULTS


The mean VAS scores decreased significantly from 7.65 to 2.07 in Group 1, from 7.96 to 1.38 in Group 2, and from 7.79 to 1.75 in total (P < 0.001). No statistically significant difference was observed between Groups 1 and 2 in terms of VAS score reduction (P = 0.128). None of the patients suffered any side effects except for 1 (2%) patient who had dyspepsia.
CONCLUSION


Parenteral lornoxicam provides significant pain relief in patients with acute renal colic. However, no significant difference was found between intramuscular and intravenous administration in terms of analgesic efficacy.",2019,No statistically significant difference was observed between Groups 1 and 2 in terms of VAS score reduction (P = 0.128).,"['51 patients who were diagnosed with acute renal colic at our clinic were included in the study', 'patients with acute renal colic', 'Acute Renal Colic']","['lornoxicam', 'intramuscular 8mg lornoxicam', 'Intravenous and Intramuscular Lornoxicam', 'intravenous 8mg lornoxicam', 'Parenteral lornoxicam']","['VAS score reduction', 'analgesic efficacy', 'Pain severity', 'mean VAS scores', 'VAS scores', 'efficacy and side effects', 'Visual Analogue Scale (VAS', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0055477', 'cui_str': 'lornoxicam'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",51.0,0.05528,No statistically significant difference was observed between Groups 1 and 2 in terms of VAS score reduction (P = 0.128).,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Soylu', 'Affiliation': 'Department of Urology, Gozde Akademi Hospital, Malatya, Turkey. drsoylu@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sarier', 'Affiliation': 'Department of Urology, Medical Park Hospital, Antalya Turkey.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Altunoluk', 'Affiliation': 'Department of Urology, Medical Palace Hospital, Kayseri, Turkey.'}, {'ForeName': 'Haluk', 'Initials': 'H', 'LastName': 'Soylemez', 'Affiliation': 'Department of Urology, Aile Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yasar Can', 'Initials': 'YC', 'LastName': 'Baydinc', 'Affiliation': 'Occupational Physician, Izmir, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4496']
1225,30009627,Early Versus Late Motion Following Volar Plating of Distal Radius Fractures.,"Background:  Distal radius fractures are common, and the trend in fixation has included the use of locked volar plating. The duration of splinting required after surgery and the effect splinting has upon outcome of the wrist are not clear. Our aim was to compare outcome of patients treated with early versus late motion protocol after volar plating.  Methods:  Thirty-three patients with distal radius fractures were prospectively and randomly enrolled into an early versus late motion study including volar plating of the distal radius fracture. Early motion included an active and passive wrist motion protocol by 14 days after surgery and delayed motion was initiated at 5 weeks. Fractures were defined as intra-articular and extra-articular, and those with, and without, ulnar styloid fracture. Motion and outcome scores (Disabilities of the Arm, Shoulder and Hand [DASH]/patient-rated wrist evaluation [PRWE]), and strength were measured through 1 year.  Results:  Wrist motion, DASH, and PRWE scores were only significantly different at 6 weeks with no significant differences at any later time points up to 1 year. One patient had complex regional pain syndrome (CRPS) and one had adhesive capsulitis in the late motion group.  Conclusions:  Following locked volar plating of distal radius fractures, early motion favored earlier return of motion along with lower DASH, PRWE, and pain scores within first 6 weeks. Although the late motion group had delayed recovery, there were no long-term significant differences in motion, strength, outcome, or pain scores. The 2 cases with complications (CRPS and adhesive capsulitis) did occur in the late motion group and may implicate late motion with these problems.",2020,"RESULTS


Wrist motion, DASH, and PRWE scores were only significantly different at 6 weeks with no significant differences at any later time points up to 1 year.","['Thirty-three patients with distal radius fractures', 'patients treated with early versus late motion protocol after volar plating']",['volar plating of the distal radius fracture'],"['adhesive capsulitis', 'Motion and outcome scores (Disabilities of the Arm, Shoulder and Hand [DASH]/patient-rated wrist evaluation [PRWE]), and strength', 'complex regional pain syndrome (CRPS', 'PRWE, and pain scores', 'motion, strength, outcome, or pain scores', 'Wrist motion, DASH, and PRWE scores', 'delayed recovery']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}]","[{'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0458219', 'cui_str': 'CRPS (Complex Regional Pain Syndromes)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",33.0,0.024611,"RESULTS


Wrist motion, DASH, and PRWE scores were only significantly different at 6 weeks with no significant differences at any later time points up to 1 year.","[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Dennison', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Charlene L', 'Initials': 'CL', 'LastName': 'Blanchard', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Elhassan', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Moran', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Alexander Y', 'Initials': 'AY', 'LastName': 'Shin', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718787880']
1226,31557064,Neoadjuvant Modified FOLFOX6 With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Final Results of the Chinese FOWARC Trial.,"PURPOSE


In the multicenter, open-label, phase III FOWARC trial, modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy resulted in a higher pathologic complete response rate than fluorouracil plus radiotherapy in Chinese patients with locally advanced rectal cancer. Here, we report the final results.
METHODS


Adults ages 18 to 75 years with stage II/III rectal cancer were randomly assigned (1:1:1) to five cycles of infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2  over 48 hours) plus radiotherapy (46.0 to 50.4 Gy delivered in 23 to 25 fractions during cycles 2 to 4) followed by surgery and seven cycles of infusional fluorouracil, the same treatment plus intravenous oxaliplatin 85 mg/m 2  on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. The primary end point was 3-year disease-free survival (DFS).
RESULTS


In total, 495 patients were randomly assigned to treatment. After a median follow-up of 45.2 months, DFS events were reported in 46, 39, and 46 patients in the fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy, and mFOLFOX6 arms. In each arm, the probability of 3-year DFS was 72.9%, 77.2%, and 73.5% ( P  = .709 by the log-rank test), the 3-year probability of local recurrence after R0/1 resection was 8.0%, 7.0%, and 8.3% ( P  = .873 by the log-rank test), and the 3-year overall survival rate was 91.3%, 89.1%, and 90.7% ( P  = .971 by log-rank test), respectively.
CONCLUSION


mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer. No significant difference in outcomes was found between mFOLFOX6 without radiotherapy and fluorouracil with radiotherapy, which requires additional investigation of the role of radiotherapy in these regimens.",2019,"CONCLUSION


mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","['Locally Advanced Rectal Cancer', 'Adults ages 18 to 75 years with stage II/III rectal cancer', 'patients with locally advanced rectal cancer', '495 patients', 'Chinese patients with locally advanced rectal cancer']","['fluorouracil with radiotherapy', 'fluorouracil with radiation', 'fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy', 'infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2  over 48 hours) plus radiotherapy', 'infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy', 'fluorouracil plus radiotherapy', 'Without Radiation Versus Fluorouracil Plus Radiation', 'infusional fluorouracil', 'oxaliplatin 85 mg/m 2  on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6', 'Neoadjuvant Modified FOLFOX6']","['3-year overall survival rate', 'probability of 3-year DFS', '3-year probability of local recurrence', '3-year DFS', '3-year disease-free survival (DFS', 'DFS events']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",495.0,0.0663218,"CONCLUSION


mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","[{'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lan', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Daoda', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Xiehe Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""The First People's Hospital, Guangzhou City, People's Republic of China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ""The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital, Foshan City, People's Republic of China.""}, {'ForeName': 'Zonghai', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Zhujiang Hospital, Nanfang University of Medical Science, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guanfu', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ""Guangdong Provincial Peoples Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhongcheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""General Hospital, Hunan Province, Changsha, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""The First Affiliated Hospital, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Xinhua Hospital, Dongguan, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhiyang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Meijin', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02309']
1227,29990345,What speech and language therapy do community dwelling stroke survivors with aphasia receive in the UK?,"BACKGROUND


Speech and language therapy provision for aphasia (a language disorder) post stroke has been studied over time through surveys completed by speech and language therapists. This paper revisits provision based on what was received by 278 patients in 21 UK speech and language therapy departments in 2014-2016.
AIMS


To explore the speech and language therapy received by community dwelling people with post stroke aphasia in the UK.
METHODS AND PROCEDURES


A quantitative content analysis was conducted by two speech and language therapist researchers. Therapy goals recorded were coded into categories and subcategories. Descriptive statistics were used to identify the frequency with which goal categories were targeted, average therapy time received, length and frequency of therapy sessions, personnel involved and mode of delivery.
OUTCOMES AND RESULTS


Forty-five percent of participants were in receipt of therapy in the three month window observed. Six goal categories were identified. Rehabilitation was the most frequent (60%) followed by enabling (17.2%), review (4.3%), assessment (3.6%), supportive (3.5%) and activity to support therapy (2.8%). The median amount of therapy received in three months was 6.3 hours at an average of one 60-minute session every two weeks. Seventy-seven percent of therapy sessions were delivered by qualified speech and language therapists and 23% by assistants. Ninety percent of sessions were one to one, face to face sessions whilst 9.5% were group sessions.
DISCUSSION


In line with previous reports, speech and language therapy for community dwelling stroke survivors with aphasia is restricted. Rehabilitation is a large focus of therapy but the intensity and dose with which it is provided is substantially lower than that required for an effective outcome. Despite this, one to one face to face therapy is favoured. More efficient methods to support more therapeutic doses of therapy are not commonly used in routine clinical services.",2018,"Rehabilitation was the most frequent (60%) followed by enabling (17.2%), review (4.3%), assessment (3.6%), supportive (3.5%) and activity to support therapy (2.8%).","['278 patients in 21 UK speech and language therapy departments in 2014-2016', 'community dwelling stroke survivors', 'community dwelling people with post stroke aphasia in the UK']",[],['median amount of therapy'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0209985,"Rehabilitation was the most frequent (60%) followed by enabling (17.2%), review (4.3%), assessment (3.6%), supportive (3.5%) and activity to support therapy (2.8%).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Palmer', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Witts', 'Affiliation': 'Speech and Language Therapy, Derbyshire Community Health Services NHS Foundation Trust, Chesterfield, United Kingdom.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Chater', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0200096']
1228,31645180,"Efficacy of Group Reminiscence Therapy on Cognition, Depression, Neuropsychiatric Symptoms, and Activities of Daily Living for Patients With Alzheimer Disease.","The current study aimed to investigate the effects of group reminiscence therapy on cognitive function, depression, neuropsychiatric symptoms, and activities of daily living in patients with mild-to-moderate Alzheimer disease (AD). A single-blind randomized parallel-design controlled trial was conducted between May 1, 2017, and April 30, 2018. Ninety patients with mild-to-moderate AD recruited from Beijing Geriatric Hospital were randomly allocated into intervention (n = 45) and control groups (n = 45). In the intervention group, group-based reminiscence therapy was performed in two 30- to 45-minute sessions weekly for 12 weeks. Control participants received only conventional drug treatments and routine daily care. Alzheimer disease-related symptoms were evaluated using the Alzheimer's Disease Assessment Scale-Cognitive section, the Cornell Scale for Depression in Dementia (CSDD), the Neuropsychiatric Inventory, and the Barthel Index. Four time points were set for data collection: baseline (before treatment), 4 weeks (during treatment), 12 weeks (end of treatment), and 24 weeks (12 weeks posttreatment). χ 2  Tests, independent  t  tests, repeated-measures analysis of variance, and Bonferroni tests were used for data analysis. Significant improvements in depressive and neuropsychiatric symptoms were found in the intervention group compared to the control group ( P  < .05). Mean CSDD scores in the intervention group were improved at all 3 time points compared to baseline and showed the greatest effect at 12 weeks ( t  = 2.076,  P  = .041) and 24 weeks follow-up ( t  = 3.834,  P  = .000) compared to controls. Group reminiscence therapy was effective for improving depressive symptoms and was beneficial for treating neuropsychiatric symptoms in patients with AD.",2020,"Mean CSDD scores in the intervention group were improved at all 3 time points compared to baseline and showed the greatest effect at 12 weeks ( t  = 2.076,  P  = .041) and 24 weeks follow-up ( t  = 3.834,  P  = .000) compared to controls.","['patients with mild-to-moderate Alzheimer disease (AD', 'Patients With Alzheimer Disease', 'Ninety patients with mild-to-moderate AD recruited from Beijing Geriatric Hospital', 'May 1, 2017, and April 30, 2018', 'patients with AD']","['conventional drug treatments and routine daily care', 'group reminiscence therapy', 'Group Reminiscence Therapy']","['depressive and neuropsychiatric symptoms', 'depressive symptoms', ""Alzheimer's Disease Assessment Scale-Cognitive section, the Cornell Scale for Depression in Dementia (CSDD"", 'Mean CSDD scores', 'Cognition, Depression, Neuropsychiatric Symptoms, and Activities of Daily Living', 'cognitive function, depression, neuropsychiatric symptoms, and activities of daily living']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0337964', 'cui_str': 'Geriatric hospital (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150321', 'cui_str': 'Rt - reminiscence therapy'}]","[{'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",90.0,0.0613789,"Mean CSDD scores in the intervention group were improved at all 3 time points compared to baseline and showed the greatest effect at 12 weeks ( t  = 2.076,  P  = .041) and 24 weeks follow-up ( t  = 3.834,  P  = .000) compared to controls.","[{'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital & School of Mental Health, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ji-Hui', 'Initials': 'JH', 'LastName': 'Lyu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Scientific Research and Teaching, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Mao-Long', 'Initials': 'ML', 'LastName': 'Gao', 'Affiliation': 'The Geriatric Institute for Clinic and Rehabilitation, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital & School of Mental Health, Capital Medical University, Beijing, China.'}, {'ForeName': 'Pei-Xian', 'Initials': 'PX', 'LastName': 'Mao', 'Affiliation': 'Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital & School of Mental Health, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Li', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital & School of Mental Health, Capital Medical University, Beijing, China.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719882099']
1229,31632654,Costs and consequences of the Family Nurse Partnership (FNP) programme in England: evidence from the Building Blocks trial.,"Background:  The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners. The Building Blocks (BB) trial aimed to explore the effectiveness and cost-effectiveness of this programme. This paper reports the results of an economic evaluation of the Building Blocks randomised controlled trial (RCT) based on a cost-consequence approach.  Methods : A large sample of 1618 families was followed-up at various intervals during pregnancy and for two years after birth. A cost-consequence approach was taken to appraise the full range of costs arising from the intervention including both health and social measures of cost alongside the consequences of the trial, specifically, the primary outcomes.  Results : A large number of potential factors were identified that are likely to attract additional costs beyond the implementation costs of the intervention including both health and non-health outcomes.  Conclusion : Given the extensive costs and only small beneficial consequences observed within the two year follow-up period, the cost-consequence model suggests that the FNP intervention is unlikely to be worth the substantial costs and policy makers may wish to consider other options for investment.  Trial registration : ISRCTN23019866 (20/04/2009).",2019,The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners.,[],"['FNP intervention', 'Family Nurse Partnership (FNP) programme', 'Family Nurse Partnership (FNP']",['effectiveness and cost-effectiveness'],[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",1618.0,0.0621001,The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners.,"[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Corbacho', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ronaldson', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, CF14 4XN, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Population Health Trials, Cardiff University, Cardiff, CF14 4ER, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.20149.1']
1230,31565411,Effects of parenting classes and economic strengthening for caregivers on the cognition of HIV-exposed infants: a pragmatic cluster randomised controlled trial in rural Zimbabwe.,"Introduction


HIV-exposed children show signs of developmental delay. We assessed the impact of a pragmatic multicomponent intervention for caregivers of HIV-exposed children aged 0-2 years in Zimbabwe.
Methods


We conducted a cluster-randomised trial from 2016 to 2018. Clusters were catchments surrounding clinics, allocated (1:1) to either National HIV guidelines standard of care or standard care plus an 18-session group intervention comprising i) early childhood stimulation (ECS) and parenting training with home visits to reinforce skills and retention in HIV care; ii) economic strengthening. Primary outcomes measured 12 months after baseline (4.5 months postintervention completion) included: i) global child development measured using the Mullen early learning composite score; ii) retention in HIV care. Analysis used mixed effects regression to account for clustering and adjusted minimally for baseline prognostic factors and was by intention to treat.
Results


Thirty clusters, 15 in each arm, were randomised. 574 dyads were recruited with 89.5% retained at follow-up. Ninety one of 281 (32.4%) were recorded as having received the complete intervention package, with 161/281 (57.3%) attending ≥14 ECS sessions. There was no evidence of an intervention effect on global child development (intervention mean 88.1 vs standard of care mean 87.6; adjusted mean difference=0.06; 95% CI -2.68 to 2.80; p=0.97) or infant retention in care (proportion of children who had missed their most recent HIV test: intervention 21.8% vs standard of care 16.9%, p=0.18). There was weak evidence that the proportion of caregivers with parental stress was reduced in the intervention arm (adjusted OR (aOR)=0.69; 95% CI 0.45 to 1.05; p=0.08) and stronger evidence that parental distress specifically was reduced (intervention arm 17.4% vs standard of care 29.1% scoring above the cut-off; aOR=0.56; 95% CI 0.35 to 0.89; p=0.01).
Conclusion


This multicomponent intervention had no impact on child development outcomes within 4.5 months of completion, but had an impact on parental distress. Maternal mental health remains a high priority.
Trial registration number


PACTR201701001387209.",2019,There was weak evidence that the proportion of caregivers with parental stress was reduced in the intervention arm (adjusted OR (aOR)=0.69;,"['574 dyads were recruited with 89.5% retained at follow-up', '2016 to 2018', 'Ninety one of 281 (32.4%) were recorded as having received the complete intervention package, with 161/281 (57.3%) attending ≥14\u2009ECS sessions', 'caregivers on the cognition of HIV-exposed infants', 'caregivers of HIV-exposed children aged 0-2 years in Zimbabwe']","['pragmatic multicomponent intervention', 'National HIV guidelines standard of care or standard care plus an 18-session group intervention comprising i) early childhood stimulation (ECS) and parenting training with home visits to reinforce skills and retention in HIV care; ii) economic strengthening', 'parenting classes and economic strengthening']","['parental distress', 'proportion of caregivers with parental stress', ' i) global child development measured using the Mullen early learning composite score; ii) retention in HIV care', 'global child development']","[{'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",574.0,0.456952,There was weak evidence that the proportion of caregivers with parental stress was reduced in the intervention arm (adjusted OR (aOR)=0.69;,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mebrahtu', 'Affiliation': 'Institute of Global Health, University College London, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Simms', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Zivai', 'Initials': 'Z', 'LastName': 'Mupambireyi', 'Affiliation': 'Centre for Sexual Health HIV/AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Rehman', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Rudo', 'Initials': 'R', 'LastName': 'Chingono', 'Affiliation': 'Centre for Sexual Health HIV/AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Matsikire', 'Affiliation': 'Centre for Sexual Health HIV/AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Rickie', 'Initials': 'R', 'LastName': 'Malaba', 'Affiliation': 'MRC Tropical Epidemiology Group, World Education Inc./Bantwana, Harare, Zimbabwe.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Ndlovu', 'Affiliation': 'MRC Tropical Epidemiology Group, World Education Inc./Bantwana, Harare, Zimbabwe.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Cowan', 'Affiliation': 'Centre for Sexual Health HIV/AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Sherr', 'Affiliation': 'Institute of Global Health, University College London, London, UK.'}]",BMJ global health,['10.1136/bmjgh-2019-001651']
1231,31642350,Editor's Choice: Consistency tendency and the theory of planned behavior: a randomized controlled crossover trial in a physical activity context.,"Objective:  This study examined the effects of consistency tendency on the predictive power of the theory of planned behavior (TPB) in relation to physical activity behavior. Methods:  In this randomized controlled cross-over trial, we recruited 770 undergraduate students from Indonesia who were randomly assigned into two groups. Participants completed physical activity versions of TPB measures at T1 (baseline) and T2 (post 1 week), and the International Physical Activity Questionnaire at T3 (post 1 month). At T1 and T2, the TPB questions were either presented in ensemble-order (i.e., consistency tendency supressed) or alternate-order (i.e., consistency tendency facilitated). Results:  The parameter estimates of the model (CFI > .92, TLI > .90, SRMR < .08, RMSEA < .08) aligned with the tenets of TPB. As compared to ensemble-order, a TPB measured in alternate-order yielded stronger cross-sectional relationships, but this pattern did not appear in the prospective relationships in TPB (i.e., intention/perceived behavioral control and behavior). Conclusions:  Consistency tendency inflated the factor correlations of cross-sectionally measured TPB variables, but the inflation was not observed in the prospective prediction of behavior. Health psychology questionnaires with items presented in ensemble order may represent a viable means of reducing the confounding effect of consistency tendency.",2020,"As compared to ensemble-order, a TPB measured in alternate-order yielded stronger cross-sectional relationships, but this pattern did not appear in the prospective relationships in TPB (i.e., intention/perceived behavioral control and behavior).  ",['770 undergraduate students from Indonesia who were randomly assigned into two groups'],['planned behavior (TPB'],"['physical activity versions of TPB measures', 'International Physical Activity Questionnaire']","[{'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",770.0,0.0292494,"As compared to ensemble-order, a TPB measured in alternate-order yielded stronger cross-sectional relationships, but this pattern did not appear in the prospective relationships in TPB (i.e., intention/perceived behavioral control and behavior).  ","[{'ForeName': 'Derwin K C', 'Initials': 'DKC', 'LastName': 'Chan', 'Affiliation': 'Faculty of Education and Human Development, The Education University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Cleoputri', 'Initials': 'C', 'LastName': 'Yusainy', 'Affiliation': 'Department of Psychology, Brawijaya University, Malang, Indonesia.'}, {'ForeName': 'Ziadatul', 'Initials': 'Z', 'LastName': 'Hikmiah', 'Affiliation': 'Department of Psychology, Brawijaya University, Malang, Indonesia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ivarsson', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'University of California, Merced, CA, USA.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Health and Physical Education, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}]",Psychology & health,['10.1080/08870446.2019.1677904']
1232,31570733,Apatinib Mesylate in the treatment of advanced progressed lung adenocarcinoma patients with EGFR-TKI resistance -A Multicenter Randomized Trial.,"Few pieces of evidence have been published on the use of Apatinib Mesylate (AM) against EGFR-TKI resistance in lung adenocarcinoma (LA) patients. Here, we investigate the clinical efficacy and safety of AM in the treatment of advanced progressed epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) resistant LA patients. We conducted a double-blind, randomized controlled trial in 68 patients admitted to 18 hospitals of Anhui province in China. The efficacy and safety of AM treatment were evaluated in terms of progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as related adverse events (AE). A literature knowledge database analysis and a pathway model reconstruction were performed to decipher the relevant mechanism may be involved. Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001). No significant difference was observed between case and control group in terms of AE, and no drug-related death occurred. Pathway analysis supports that Apatinib can be repurposed for the treatment of LA. Our results suggested that AM could be a potential option for advanced progressed LA patients to combat EGFR-TKI resistance.",2019,"Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001).","['68 patients admitted to 18 hospitals of Anhui province in China', 'lung adenocarcinoma (LA) patients', 'advanced progressed lung adenocarcinoma patients with EGFR-TKI resistance -A']","['AM', 'Apatinib Mesylate']","['efficacy in PFS', 'ORR', 'progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as related adverse events (AE', 'efficacy and safety', 'DCR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C4547969', 'cui_str': 'apatinib mesylate'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",68.0,0.0629498,"Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': ""Department of Respiratory, the People's Hospital of Tongling, Tongling, Anhui province, 244000, China. fangping1964@126.com.""}, {'ForeName': 'Liqin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory, Yijishan Hospital of Wannan Medical College, No. 2 Zheshan West Road, Wuhu, Anhui Province, 241000, China.'}, {'ForeName': 'Xianru', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory, Tongling Municipal Hospital, No. 2999 Changjiang West Road, Tongling, Anhui Province, 244099, China.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Respiratory, Anqing First People's Hospital, No. 42 Xiaosu Road, Anqing, Anhui Province, 246000, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Respiratory, Xuancheng People's Hospital, No. 15 Huancheng North Road, Xuancheng, Anhui Province, 242000, China.""}, {'ForeName': 'Qi-An', 'Initials': 'QA', 'LastName': 'Jiang', 'Affiliation': 'Department of Respiratory, Anqing Municipal Hospital, No.172 Renmin Road, Yingjiang District, Anqing, Anhui Province, 246000, China.'}, {'ForeName': 'Mingbao', 'Initials': 'M', 'LastName': 'Zha', 'Affiliation': 'Department of Respiratory, Wuhu City Hospital of Traditional Chinese Medicine, No. 240 Jiuhua Middle Road, Jinghu District, Wuhu, Anhui Province, 2461002, China.'}, {'ForeName': 'Anastasia P', 'Initials': 'AP', 'LastName': 'Nesterova', 'Affiliation': 'Department of Biology Solution, Elsevier, 1150 18th St NW, Washington, DC 20036, USA.'}, {'ForeName': 'Hongbao', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Biology Solution, Elsevier, 1150 18th St NW, Washington, DC 20036, USA. caohon2010@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-50350-6']
1233,29792556,Effect of Wii training on hand function in children with hemiplegic cerebral palsy.,"Objective : The purpose of this study was to investigate the effect of Wii training on hand function in children with hemiplegic cerebral palsy.  Methods : A randomized controlled trial was conducted in 40 children with hemiplegic cerebral palsy (8-12 years). The experimental group received Wii training involving four games for 40 minutes a day, three times a week for 12 weeks plus usual care. The control group received usual care alone. Outcomes were spasticity measured using the modified Ashworth scale, grip strength measured using dynamometry, and hand function measured using the Peabody developmental motor scale (2nd ed.). Outcomes were measured at baseline and after 12 weeks of intervention.  Results : Spasticity in the experimental group decreased by 0.4 out of 4.0 (95% CI 0.1 to 0.8) more than the control group by 12 weeks. Power grip strength increased by 1.6 kg (95% CI 0.7 to 2.5) and pinch grip strength by 1.2 kg (95% CI 0.8 to 1.6) more than the control group by 12 weeks. Hand function increased by 6 out of 52 (95% CI 5 to 7) more than the control group by 12 weeks.  Conclusion : Wii training plus usual care decreases spasticity and increases grip strength and hand function in children with hemiplegic cerebral palsy.",2020,Wii training plus usual care decreases spasticity and increases grip strength and hand function in children with hemiplegic cerebral palsy.,"['children with hemiplegic cerebral palsy', '40 children with hemiplegic cerebral palsy (8-12\xa0years']","['Wii training', 'usual care alone']","['spasticity measured using the modified Ashworth scale, grip strength measured using dynamometry, and hand function measured using the Peabody developmental motor scale', 'pinch grip strength', 'Spasticity', 'Power grip strength', 'Hand function', 'grip strength and hand function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0427081', 'cui_str': 'Pinch grip (observable entity)'}]",40.0,0.0507832,Wii training plus usual care decreases spasticity and increases grip strength and hand function in children with hemiplegic cerebral palsy.,"[{'ForeName': 'Shamekh Mohamed', 'Initials': 'SM', 'LastName': 'El-Shamy', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mohamed Fawzy', 'Initials': 'MF', 'LastName': 'El-Banna', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1479810']
1234,31533646,"Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial.","BACKGROUND


Prevention of new HIV infections is a critical public health issue. The highest HIV testing gaps are in men, adolescents 15-19 years old, and adults 40 years and older. Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise. Community-based strategies, however, are resource intensive, costly and not widely implemented. A community-led approach to health interventions involves supporting communities to plan and implement solutions to improve their health. This trial aims to determine if community-led delivery of HIVST can improve HIV testing uptake, ART initiation, and broader social outcomes in rural Malawi.
METHODS


The trial uses a parallel arm, cluster-randomised design with group village heads (GVH) and their defined catchment areas randomised (1:1) to community-led HIVST or continue with the standard of the care (SOC). As part of the intervention, informal community health cadres are supported to plan and implement a seven-day HIVST campaign linked to HIV treatment and prevention. Approximately 12 months after the initial campaign, intervention GVHs are randomised to lead a repeat HIVST campaign. The primary outcome includes the proportion of adolescents 15-19 years old who have tested for HIV in their lifetime. Secondary outcomes include recent testing in adults 40 years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma. Outcomes will be measured through cross-sectional surveys and clinic registers. Economic evaluation will determine the cost per person tested, cost per person diagnosed, and incremental cost effectiveness ratio.
DISCUSSION


To the best of our knowledge, this is the first trial to assess the effectiveness of community-led HTS, which has only recently been enabled by the introduction of HIVST. Community-led delivery of HIVST is a promising new strategy for providing periodic HIV testing to support HIV prevention in rural communities. Further, introduction of HIVST through a community-led framework seems particularly apt, with control over healthcare concurrently devolved to individuals and communities.
TRIAL REGISTRATION


Clinicaltrials.gov registry ( NCT03541382 ) registered 30 May 2018.",2019,"Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise.","['rural Malawi', 'rural communities', 'adolescents 15-19\u2009years old who have tested for HIV in their lifetime', 'men, adolescents 15-19\u2009years old, and adults 40\u2009years and older', 'group village heads (GVH) and their defined catchment areas randomised (1:1) to']","['Community-based HIV testing services (HTS', 'community-led HIVST or continue with the standard of the care (SOC', 'HIVST']",['recent testing in adults 40\u2009years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma'],"[{'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",,0.189123,"Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise.","[{'ForeName': 'Pitchaya P', 'Initials': 'PP', 'LastName': 'Indravudh', 'Affiliation': 'Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK. peach.indravudh@gmail.com.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Moses K', 'Initials': 'MK', 'LastName': 'Kumwenda', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Nzawa', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chilongosi', 'Affiliation': 'Population Services International, Lilongwe, Malawi.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Desmond', 'Affiliation': 'Clinical Sciences Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Nyirenda', 'Affiliation': 'Department of HIV and AIDS, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Cheryl C', 'Initials': 'CC', 'LastName': 'Johnson', 'Affiliation': 'Department of HIV/AIDS, World Health Organisation, Geneva, Switzerland.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Baggaley', 'Affiliation': 'Department of HIV/AIDS, World Health Organisation, Geneva, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Johannesburg, South Africa.'}, {'ForeName': 'Fern', 'Initials': 'F', 'LastName': 'Terris-Prestholt', 'Affiliation': 'Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.'}]",BMC infectious diseases,['10.1186/s12879-019-4430-4']
1235,31557763,Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial.,"Importance


The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists.
Objective


To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI).
Design, Setting, and Participants


This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15 991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure.
Interventions


The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin.
Main Outcomes and Measures


The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction.
Results


Of 15 968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P = .07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P = .004).
Conclusions and Relevance


Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI.
Trial Registration


ClinicalTrials.gov identifier: NCT01813435.",2019,"This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI.","['acute coronary syndromes (ACS', '968 participants', 'patients with ACS who, within this time frame', 'Acute Coronary Syndromes', 'Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure', '7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group', '130 secondary/tertiary care hospitals in different countries, with 15\u202f991 unselected patients with stable coronary artery disease or ACS undergoing PCI', 'patients with ACS beyond 1 month after percutaneous coronary intervention (PCI']","['Aspirin', 'Ticagrelor', 'ticagrelor alone or ticagrelor and aspirin', 'aspirin plus ticagrelor', 'aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS', 'aspirin', 'ticagrelor', 'aspirin monotherapy']","['composite of all-cause death or new Q-wave myocardial infarction', 'bleeding risk']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4517746', 'cui_str': '3750'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",130.0,0.0780479,"This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI.","[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'PLx Pharma Inc, Sparta, New Jersey.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chun Ching', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rademaker-Havinga', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, England.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, Boston, Massachusetts.""}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida, College of Medicine, Jacksonville.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Giessen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials, Université Paris Diderot, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, and INSERM U-1148, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.3355']
1236,31647577,"Efficacy, Tolerability, and Safety of DFN-15 (Celecoxib Oral Solution, 25 mg/mL) in the Acute Treatment of Episodic Migraine: A Randomized, Double-Blind, Placebo-Controlled Study.","OBJECTIVE


The objective of this study was to evaluate the efficacy, tolerability, and safety of 120 mg DFN-15 vs placebo for the acute treatment of migraine.
BACKGROUND


Certain nonsteroidal anti-inflammatory drugs (NSAIDs) are guideline-recommended therapies for the acute treatment of migraine, but patients who use them may have issues with gastrointestinal tolerability. Celecoxib, a selective inhibitor of cyclooxygenase-2, produces analgesia similar to nonselective NSAIDs. DFN-15 is an oral, ready-made liquid solution of celecoxib being investigated for the acute treatment of migraine.
METHODS


A randomized, double-blind, placebo-controlled, efficacy, tolerability, and safety study in adults with migraine was conducted. Subjects treated a single migraine attack with 120 mg DFN-15 or placebo as soon as possible after the onset of pain of moderate to severe intensity. The 2 independent coprimary efficacy endpoints were the proportion of subjects with freedom from pain and the absence of the most bothersome symptom (MBS) at 2 hours postdose. A second double-blind treatment period followed the first, but did not contribute to the primary outcomes and will be reported elsewhere.
RESULTS


There were 622 subjects randomized (1:1) to double-blind treatment with either 120 mg DFN-15 or placebo, and 567 (91.2%) treated a migraine with study drug (n = 285 DFN-15; n = 282 placebo). Groups were balanced in demographic characteristics; the mean age was 40, and most subjects were female (87% [494/567]). At 2 hours postdose, DFN-15 was significantly superior to placebo for pain freedom (35.6% [98/275] vs 21.7% [57/263], P < .001), with an odds ratio (95% CI) of 2.00 (1.36, 2.94) and for freedom from the MBS (57.8% [134/232] vs 44.8% [104/232], P = .007), with an odds ratio (95% CI) of 1.68 (1.17, 2.43). A total of 13.3% (38/285) of DFN-15-treated subjects and 8.9% (25/282) of placebo-treated subjects reported a treatment-emergent adverse event (TEAE). Study drug-related TEAEs were reported by 9.1% (26/285) of DFN-15 subjects and 6.0% (17/282) of placebo subjects, the most common of which were dysgeusia (4.2% [12/285] vs 1.4% [4/282]) and nausea (3.2% [9/285] vs 1.8% [5/282]). No subjects treated with DFN-15 reported TEAEs that were severe or led to withdrawal, and no serious TEAEs or deaths were reported in the study.
CONCLUSIONS


DFN-15 was significantly more effective than placebo for the acute treatment of migraine, with a generally favorable tolerability and safety profile.",2020,"At 2 hours postdose, DFN-15 was significantly superior to placebo for pain freedom (35.6% [98/275] vs 21.7% [57/263], P ","['Episodic Migraine', 'adults with migraine']","['Placebo', 'DFN-15 or placebo', 'Celecoxib', 'DFN-15', 'Celecoxib Oral Solution, 25 mg/mL', 'DFN-15 vs placebo', 'placebo', 'celecoxib', 'migraine with study drug (n\xa0=\xa0285 DFN-15; n\xa0=\xa0282 placebo']","['efficacy, tolerability, and safety', 'dysgeusia', 'proportion of subjects with freedom from pain and the absence of the most bothersome symptom (MBS', 'efficacy, tolerability', 'Efficacy, Tolerability, and Safety', 'treatment-emergent adverse event (TEAE', 'nausea', 'severe or led to withdrawal, and no serious TEAEs or deaths', 'pain freedom']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",622.0,0.461719,"At 2 hours postdose, DFN-15 was significantly superior to placebo for pain freedom (35.6% [98/275] vs 21.7% [57/263], P ","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Munjal', 'Affiliation': ""Dr. Reddy's Laboratories, Princeton, NJ, USA.""}, {'ForeName': 'Elimor', 'Initials': 'E', 'LastName': 'Brand-Schieber', 'Affiliation': ""Dr. Reddy's Laboratories, Princeton, NJ, USA.""}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}]",Headache,['10.1111/head.13663']
1237,31642953,"Randomized, controlled trial of fesoterodine fumarate for overactive bladder in Parkinson's disease.","AIMS


To evaluate short-term efficacy and safety of fesoterodine fumarate in Parkinson's disease (PD) patients with overactive bladder (OAB) symptoms.
METHODS


This is a randomized, double-blind, placebo-controlled study. It also has an open-label extension phase. From May 2016 to May 2018, 63 patients were randomized to receive fesoterodine 4 mg or placebo for 4 weeks. At the end of 4 weeks of randomization phase, patients were received fesoterodine fumarate 4 mg daily for another 4 weeks at the open-label extension phase. The change in the mean number of micturition episodes per 24 h period was the primary outcome measure of the study.
RESULTS


The number of micturition episodes per 24 h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001). Also the mean number of nocturia and urgency episodes decreased in the fesoterodine group. In the open-label phase, the mean number of micturition, urgency and urgency urinary incontinence episodes were improved significantly. The number of nocturia episodes did not change in the open-label phase. Cognitive functions were stable after 4 weeks of fesoterodine 4 mg treatment.
CONCLUSIONS


OAB symptoms were significantly improved in older adults with PD under fesoterodine fumarate treatment, and this advantage continued in the open-label portion in the short term. In this randomized controlled study, the cognitive functions of the participants were not affected by fesoterodine 4 mg treatment compared with placebo.",2020,The number of micturition episodes per 24 h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001).,"[""Parkinson's disease (PD) patients with overactive bladder (OAB) symptoms"", 'From May 2016 to May 2018, 63 patients', 'older adults with PD under', ""overactive bladder in Parkinson's disease""]","['placebo', 'fesoterodine', 'fesoterodine 4\xa0mg or placebo', 'fesoterodine fumarate']","['Cognitive functions', 'mean number of nocturia and urgency episodes', 'mean number of micturition episodes', 'number of nocturia episodes', 'number of micturition episodes', 'OAB symptoms', 'mean number of micturition, urgency and urgency urinary incontinence episodes']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C2343854', 'cui_str': 'Fesoterodine Fumarate'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]",63.0,0.284208,The number of micturition episodes per 24 h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001).,"[{'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Yonguc', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey. tyonguc@gmail.com.'}, {'ForeName': 'Ertugrul', 'Initials': 'E', 'LastName': 'Sefik', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Inci', 'Affiliation': 'Department of Neurology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Ozge Yılmaz', 'Initials': 'OY', 'LastName': 'Kusbeci', 'Affiliation': 'Department of Neurology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Celik', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Mehmet Erhan', 'Initials': 'ME', 'LastName': 'Aydın', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Polat', 'Affiliation': 'Department of Urology, Amasya University Sabuncuoglu Serefeddin Training and Research Hospital, Amasya, Turkey.'}]",World journal of urology,['10.1007/s00345-019-02981-7']
1238,31605929,Influence of shading technique on mechanical fatigue performance and optical properties of a 4Y-TZP ceramic for monolithic restorations.,"This study aimed to evaluate the effect of shading procedures on the fatigue performance and optical properties of an yttria-stabilized tetragonal zirconia polycrystal ceramic (4Y-TZP - stabilized by 4 mol% Y 2 O 3 ). Disc-shaped specimens were produced at pre-sintered stage and randomly allocated into 5 groups (n=15) considering the shading technique: Ctrl (no pigmentation); Brush 1× and Brush 3× (brushing on 1 or 3 applications, respectively); Immer 2min and Immer 4min (immersion for 2 or 4 min, respectively). Following each pigment application, the specimens were dried in accordance with the manufacturers' guidelines (15 min in a stove at 70 °C) and sintered in a specific furnace. Biaxial flexural fatigue test followed a step-stress approach (initial strength: 200 MPa; step-size: 25 MPa; 10.000 cycles/step; frequency: 20 Hz). Optical measurements were conducted in a spectrophotometer following the CIEDE2000 parameters. Roughness, topography, crystalline grain size, crystalline phase content and fractography analysis were also performed. The flexural fatigue strength (FFS) and the number of cycles to fracture (CFF) were statistically affected by pigmentation techniques (mean FFS in MPa/mean CFF): Ctrl (446.7/105,619) > Brush 1 × (436.7/102,854) ≥ Brush 3 × (405.0/89,962) ≥ Immer 2 min (395.0/85,103) ≥ Immer 4 min (383.3/81,382), although the exposure intensity (increase in number of applications or in application time) to the pigment had no effect (Brush 1 × = Brush 3 × ; Immer 2 min = Immer 4 min). Regarding optical properties, shading techniques similarly affected translucency and opalescence parameters, regardless of the exposure intensity to the pigment (Brush 1 × = Brush 3 × = Immer 2 min = Immer 4 min > Ctrl), whereas the exposure intensity to the pigment only promoted relevant alterations in the color change parameter (ΔE 00 ) for the brushing technique (Brush 3 × > Brush 1 × ). No difference was observed in crystalline phase content, topographic pattern or roughness, although an increase in the zirconia grain size could be detected. Thus, the shading technique might affect the fatigue behavior and promote optical changes in a 4Y-TZP ceramic.",2020,"No difference was observed in crystalline phase content, topographic pattern or roughness, although an increase in the zirconia grain size could be detected.",['monolithic restorations'],"['shading procedures', 'yttria-stabilized tetragonal zirconia polycrystal ceramic', 'shading technique: Ctrl (no pigmentation); Brush 1× and Brush 3× (brushing on 1 or 3 applications, respectively); Immer 2min and Immer 4min (immersion', 'shading technique']","['mechanical fatigue performance and optical properties', 'flexural fatigue strength (FFS) and the number of cycles to fracture (CFF', 'crystalline phase content, topographic pattern or roughness', 'number of applications or in application time', 'fatigue performance and optical properties', 'zirconia grain size', 'Roughness, topography, crystalline grain size, crystalline phase content and fractography analysis']","[{'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1568826', 'cui_str': 'Yttria-Stabilized Tetragonal Zirconia Polycrystals Ceramic'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0439748', 'cui_str': 'Flexural (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0263486,"No difference was observed in crystalline phase content, topographic pattern or roughness, although an increase in the zirconia grain size could be detected.","[{'ForeName': 'Maria Luiza', 'Initials': 'ML', 'LastName': 'Auzani', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: marialuizaauzani@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Gabriel Kalil', 'Initials': 'GK', 'LastName': 'Rocha Pereira', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.103457']
1239,29752024,Socioeconomic drivers of vaccine uptake: An analysis of the data of a geographically defined cluster randomized cholera vaccine trial in Bangladesh.,"BACKGROUND


Evaluations of oral cholera vaccines (OCVs) have demonstrated their effectiveness in diverse settings. However, low vaccine uptake in some settings reduces the opportunity for prevention. This paper identifies the socioeconomic factors associated with vaccine uptake in a mass vaccination program.
METHODS


This was a three-arm (vaccine, vaccine plus behavioral change, and non-intervention) cluster randomized trial conducted in Dhaka, Bangladesh. Socio-demographic and vaccination data were collected from 268,896 participants. A geographical information system (GIS) was used to design and implement the vaccination program. A logistic regression model was used to assess the association between vaccine uptake and socioeconomic characteristics.
RESULTS


The GIS supported the implementation of the vaccination program by identifying ideal locations of vaccination centres for equitable population access, defining catchment areas of daily activities, and providing daily coverage maps during the campaign. Among 188,206 individuals in the intervention arms, 123,686 (66%) received two complete doses, and 64,520 (34%) received one or no doses of the OCV. The vaccine uptake rate was higher in females than males (aOR: 1.80; 95% CI = 1.75-1.84) and in younger (<15 years) than older participants (aOR: 2.19; 95% CI = 2.13-3.26). Individuals living in their own house or having a higher monthly family expenditure were more likely to receive the OCV (aOR: 1.60; 95% CI = 1.50-1.70 and aOR: 1.14; 95% CI = 1.10-1.18 respectively). Individuals using treated water for drinking or using own tap as the source of water were more likely to receive the OCV (aOR: 1.23; 95% CI = 1.17-1.29 and aOR: 1.14; 95% CI = 1.02-1.25 respectively) than their counterpart. Vaccine uptake was also significantly higher in participants residing farther away from health facilities (aOR: 95% 1.80; CI = 1.36-2.37).
CONCLUSION


The GIS was useful in designing field activities, facilitating vaccine delivery and identifying socioeconomic drivers of vaccine uptake in the urban area of Bangladesh. Addressing these socioeconomic drivers may help improve OCV uptake, thereby effectiveness of the OCV in a community.",2018,"The GIS was useful in designing field activities, facilitating vaccine delivery and identifying socioeconomic drivers of vaccine uptake in the urban area of Bangladesh.","['268,896 participants', 'Socioeconomic drivers of vaccine uptake', 'Bangladesh']",['oral cholera vaccines (OCVs'],"['Vaccine uptake', 'vaccine uptake rate', 'OCV uptake']","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]",268896.0,0.259784,"The GIS was useful in designing field activities, facilitating vaccine delivery and identifying socioeconomic drivers of vaccine uptake in the urban area of Bangladesh.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'School of Public Health and Community Medicine, UNSW Australia, NSW, Australia; International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh. Electronic address: amiticddrb@yahoo.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rosewell', 'Affiliation': 'School of Public Health and Community Medicine, UNSW Australia, NSW, Australia.'}, {'ForeName': 'C Raina', 'Initials': 'CR', 'LastName': 'MacIntyre', 'Affiliation': 'School of Public Health and Community Medicine, UNSW Australia, NSW, Australia.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, USA; Korea University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}]",Vaccine,['10.1016/j.vaccine.2018.04.084']
1240,29921538,Peer influence processes as mediators of effects of a middle school substance use prevention program.,"BACKGROUND


Peer influence processes have been linked to escalation in substance use during the middle school years, particularly among at-risk youth. In this study, we report on an approach to prevention that attempts to counteract peer influence by interrupting the process of deviant peer clustering, in which socially marginalized youth self-aggregate and reinforce delinquent behavior, including substance use. We aimed to interrupt this process by implementing collaborative, group-based learning activities in school (i.e., cooperative learning).
METHODS


In a cluster randomized trial in the Pacific Northwest (N = 1460 7th-grade students in 15 schools), we tested whether cooperative learning can reduce alcohol and tobacco use, and whether these effects are mediated by reductions in the amount of alcohol and tobacco use among one's friends. Intervention schools were provided with training in cooperative learning, and data were collected in September/October 2016 (baseline) and March 2017 (follow-up).
RESULTS


Results indicated that cooperative learning significantly lowered rates of growth in alcohol (β = -0.60 [-0.36|-0.84]; p < .001) and tobacco use (β = -0.58 [-0.21|-0.94]; p = .01) between baseline and follow-up in intervention schools as compared to control schools. These effects were mediated by reductions in the prevalence of alcohol and tobacco use, respectively, among self-selected friends.
CONCLUSIONS


Cooperative learning was able to significantly reduce the prevalence of both alcohol and tobacco use in friendship networks during the school year. The lower prevalence of alcohol and tobacco use among friends, in turn, reduced individual use at follow-up. This study was registered as trial NCT03119415 in ClinicalTrials.gov.",2018,"CONCLUSIONS


Cooperative learning was able to significantly reduce the prevalence of both alcohol and tobacco use in friendship networks during the school year.",['Pacific Northwest (N = 1460 7th-grade students in 15 schools'],['cooperative learning'],['rates of growth in alcohol'],"[{'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",,0.0279829,"CONCLUSIONS


Cooperative learning was able to significantly reduce the prevalence of both alcohol and tobacco use in friendship networks during the school year.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'Oregon Research Institute, 1776 Millrace, Eugene, OR 97403, United States. Electronic address: markv@ori.org.'}, {'ForeName': 'Cary J', 'Initials': 'CJ', 'LastName': 'Roseth', 'Affiliation': 'Michigan State University, College of Education, East Lansing, MI, United States. Electronic address: croseth@msu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.06.016']
1241,29681047,"The Effect of Local Anesthetic Agent Infiltration Around Nephrostomy Tract On Postoperative Pain Control After Percutaneous Nephrolithotomy: A single-centre, randomised, double-blind, placebocontrolled clinical trial.","PURPOSE


Insufficient alleviation of pain after percutaneous nephrolithotomy causes patient dissatisfaction and generates additional morbidity factors by preventing early mobilization. This study investigated the effects of bupivacaine infiltration with two different doses around the nephrostomy tract after percutaneous nephrolithotomy.
MATERIALS AND METHODS


Patients who underwent subcostal single entrance percutaneous nephrolithotomy were randomly divided into 3 groups of 20 patients. While the first and second group were planned to receive bupivacaine at rates of 0.5% and 0.25% respectively, the third group was planned to receive a placebo agent to preserve the doubly blinded nature of the study.
RESULTS


A statistically significant difference was found in the number of patients using tramadole. The frequency of analgesic administration was found lower in the two groups that received bupivacaine in comparison to the group that did not, while the time of the first analgesic administration in the group that received high dose bupivacaine was significantly later than the other groups. Although there was no difference between the groups in terms of total amount of analgesic usage, patients who received higher concentrations of bupivacaine were likely to requirea lower amount of narcotic agent. The frequency of analgesic administration decreased significantly in patients of both groups that received bupivacaine. Moreover, by administering bupivacaine at a 0.5% rate, fewer patients (50%) required narcotic analgesia and the first time of analgesic administration was found to be significantly later.
CONCLUSION


Administering bupivacaine at a 0.5% rate around the nephrostomy tract after surgery was demonstrated to be more effective.",2018,"The frequency of analgesic administration was found lower in the two groups that received bupivacaine in comparison to the group that did not, while the time of the first analgesic administration in the group that received high dose bupivacaine was significantly later than the other groups.",['Patients who underwent subcostal single entrance percutaneous nephrolithotomy were randomly divided into 3 groups of 20 patients'],"['Local Anesthetic Agent Infiltration Around Nephrostomy Tract', 'placebo', 'bupivacaine', 'Percutaneous Nephrolithotomy', 'percutaneous nephrolithotomy']","['frequency of analgesic administration', 'Postoperative Pain Control', 'narcotic analgesia and the first time of analgesic administration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0337095', 'cui_str': 'Entrance (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic (procedure)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0594253,"The frequency of analgesic administration was found lower in the two groups that received bupivacaine in comparison to the group that did not, while the time of the first analgesic administration in the group that received high dose bupivacaine was significantly later than the other groups.","[{'ForeName': 'Gokce', 'Initials': 'G', 'LastName': 'Dundar', 'Affiliation': 'Urology Department, Cizre State Hospital, Şırnak, Turkey. dr@gokcedundar.com.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Gokcen', 'Affiliation': 'Department of Urology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Gokce', 'Affiliation': 'Department of Urology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Emin Yener', 'Initials': 'EY', 'LastName': 'Gultekin', 'Affiliation': 'Department of Urology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4145']
1242,31222540,Pre-operative intravenous steroid improves pain and joint mobility after total knee arthroplasty in Chinese population: a double-blind randomized controlled trial.,"INTRODUCTION


This study aims to investigate the effect of pre-operative intravenous methylprednisolone on post-operative pain control and joint mobility in Chinese patients undergoing single primary total knee arthroplasty.
METHODS


This is a prospective, randomized, double-blinded, placebo-controlled single-centre trial. Sixty subjects were randomized into intervention and control group. The peri-operative anaesthetic and analgesic regimes were standardized. The intervention group received 125 mg methylprednisolone intravenously on the induction of anaesthesia. Subjects were assessed at 24, 30 and 48 h after surgery and upon discharge for pain scores and range of movement from the operated knee. Change in C-reactive protein level was calculated. Patient's satisfaction was recorded. Adverse reactions were documented. Subjects were followed up at 6 weeks, 4 months and 1 year.
RESULTS


Rest pain and pain on movement were significantly reduced in the methylprednisolone group at 24 and 30 h after surgery (ANOVA p = 0.030, p = 0.003, p = 0.032, p = 0.010). The methylprednisolone group demonstrated a greater range of movement from the operated knee up to 30 h after surgery (ANOVA p = 0.031). Post-operative C-reactive protein level was significantly less in the methylprednisolone group (p < 0.001). Methylprednisolone group had a higher patient's satisfaction than the control group (p < 0.01). No adverse effects were noted at the 1-year follow-up.
CONCLUSION


Pre-operative intravenous methylprednisolone improves post-operative pain and joint mobility after total knee arthroplasty up to 30 h after operation. It results in a higher patients' satisfaction. It can act as an effective adjunct in the multimodal analgesic regime.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03082092.",2019,Methylprednisolone group had a higher patient's satisfaction than the control group (p < 0.01).,"['Sixty subjects', 'total knee arthroplasty in Chinese population', 'Chinese patients undergoing single primary total knee arthroplasty']","['Methylprednisolone', 'Pre-operative intravenous steroid', 'placebo', 'methylprednisolone', 'pre-operative intravenous methylprednisolone']","['Change in C-reactive protein level', 'Rest pain and pain on movement', 'Adverse reactions', 'post-operative pain and joint mobility', ""patient's satisfaction"", 'adverse effects', 'range of movement from the operated knee', 'pain and joint mobility', 'Post-operative C-reactive protein level']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0563322', 'cui_str': 'Intravenous steroid injection (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",60.0,0.368583,Methylprednisolone group had a higher patient's satisfaction than the control group (p < 0.01).,"[{'ForeName': 'Bernadette Lok Yiu', 'Initials': 'BLY', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong. cly919@ha.org.hk.'}, {'ForeName': 'Eric Hang Kwong', 'Initials': 'EHK', 'LastName': 'So', 'Affiliation': 'Department of Anaesthesiology and Operating Theatre Services, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Grace Kit Man', 'Initials': 'GKM', 'LastName': 'Hui', 'Affiliation': 'Department of Anaesthesiology and Operating Theatre Services, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Boogie Pui Ki', 'Initials': 'BPK', 'LastName': 'Yung', 'Affiliation': 'Physiotherapy Department, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Ada Sau Kwan', 'Initials': 'ASK', 'LastName': 'Tsui', 'Affiliation': 'Physiotherapy Department, Hong Kong Buddhist Hospital, 10 Heng Lam Street, Lok Fu, Kowloon, Hong Kong.'}, {'ForeName': 'Oscar Kam Fung', 'Initials': 'OKF', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Hong Kong Buddhist Hospital, Lok Fu, Hong Kong.'}, {'ForeName': 'Margaret Wai Yee', 'Initials': 'MWY', 'LastName': 'Poon', 'Affiliation': 'Physiotherapy Department, Hong Kong Buddhist Hospital, 10 Heng Lam Street, Lok Fu, Kowloon, Hong Kong.'}, {'ForeName': 'Andy C M', 'Initials': 'ACM', 'LastName': 'Chan', 'Affiliation': 'Physiotherapy Department, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Steven H S', 'Initials': 'SHS', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesiology and Operating Theatre Services, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Paul Sin Chuen', 'Initials': 'PSC', 'LastName': 'Yip', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02469-5']
1243,31872153,Effects of dietary nitrate and folate supplementation on blood pressure in hypertensive Tanzanians: Design and baseline characteristics of a feasibility trial.,"The burden of hypertension in Sub-Saharan African countries is rising. Low-cost and effective interventions are needed to mitigate these alarming trends. No evidence is available on the use of dietary nitrate for treating hypertension in African populations. The objectives of this study are to assess the feasibility and efficacy of using beetroot and folate as a combined dietary intervention to treat Tanzanian adults with pre- and mild to moderate hypertension. This was a three-arm double-blind, placebo-controlled, parallel randomised clinical trial conducted within the Hai Demographic Surveillance Site in the Kilimanjaro region in Tanzania. 48 participants were randomised to one of three groups for a 60-day intervention period. Group 1: Combined dietary intervention (beetroot juice and folate), Group 2: Single dietary intervention (beetroot juice and placebo capsule), and Group 3: Control group (placebo beetroot juice and placebo capsule). The primary outcome of the trial was to evaluate the feasibility of the study in a low-income setting. Trial assessments included resting clinic and ambulatory 24-hr blood pressure measurements, lifestyle and dietary questionnaires and collection of biological samples. Our cohort included 8 (16.7%) males and 40 (83.3%) females with mean age 60.7 years (SD 6.5). The mean (SD) BMI, clinic systolic blood pressure and ambulatory systolic blood pressure at baseline were 27.6 kg/m 2  (5.4), 151.0 (19.4), and 140.4 (15.0) mmHg, respectively. Eight (16.7%) participants were classified as pre-hypertensive, 20 (41.7%) as stage-1 hypertensive, and 20 (41.7%) as stage-2 hypertensive. Overall, the results support the feasibility of a study of this nature within a hypertensive African population.
Trial registration number


ISRCTN67978523.",2019,"The mean (SD) BMI, clinic systolic blood pressure and ambulatory systolic blood pressure at baseline were 27.6 kg/m 2  (5.4), 151.0 (19.4), and 140.4 (15.0) mmHg, respectively.","['48 participants', 'hypertensive African population', 'hypertensive Tanzanians', 'Our cohort included 8 (16.7%) males and 40 (83.3%) females with mean age 60.7 years (SD 6.5', 'Tanzanian adults with pre- and mild to moderate hypertension', 'Eight (16.7%) participants were classified as pre-hypertensive, 20 (41.7%) as stage-1 hypertensive, and 20 (41.7%) as stage-2 hypertensive', 'Hai Demographic Surveillance Site in the Kilimanjaro region in Tanzania', 'African populations']","['dietary nitrate', 'dietary nitrate and folate supplementation', 'placebo', 'Combined dietary intervention (beetroot juice and folate), Group 2: Single dietary intervention (beetroot juice and placebo capsule), and Group 3: Control group (placebo beetroot juice and placebo capsule', 'beetroot and folate']","['burden of hypertension', 'blood pressure', 'resting clinic and ambulatory 24-hr blood pressure measurements, lifestyle and dietary questionnaires and collection of biological samples', 'feasibility and efficacy', 'mean (SD) BMI, clinic systolic blood pressure and ambulatory systolic blood pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",48.0,0.26893,"The mean (SD) BMI, clinic systolic blood pressure and ambulatory systolic blood pressure at baseline were 27.6 kg/m 2  (5.4), 151.0 (19.4), and 140.4 (15.0) mmHg, respectively.","[{'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Kandhari', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Claremont Road, Newcastle on Tyne, UK.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Prabhakar', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Claremont Road, Newcastle on Tyne, UK.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical Centre and Kilimanjaro Christian Medical University College, Tanzania.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Rogathi', 'Affiliation': 'Kilimanjaro Christian Medical Centre and Kilimanjaro Christian Medical University College, Tanzania.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Temu', 'Affiliation': 'Kilimanjaro Christian Medical Centre and Kilimanjaro Christian Medical University College, Tanzania.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Gray', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Stella-Maria', 'Initials': 'SM', 'LastName': 'Paddick', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Newcastle on Tyne, NE2 4HH, UK.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100472']
1244,29609568,A cluster randomized controlled trial to assess the impact on intimate partner violence of a 10-session participatory gender training curriculum delivered to women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01): study protocol.,"BACKGROUND


Worldwide, almost one third (30%) of women who have been in a relationship have experienced physical and/or sexual violence from an intimate partner. Given the considerable negative impacts of intimate partner violence (IPV) on women's physical health and well-being, there is an urgent need for rigorous evidence on violence prevention interventions.
METHODS


The study, comprising a cluster randomized controlled trial (RCT) and in-depth qualitative study, will assess the impact on women's past year experience of physical and/or sexual IPV of a participatory gender training curriculum (MAISHA curriculum) delivered to women participating in group-based microfinance in Tanzania. More broadly, the study aims to learn more about the factors that contribute to women's vulnerability to violence and understand how the intervention impacts on the lives of women and their families. Sixty-six eligible microfinance loan groups are enrolled and randomly allocated to: the 10-session MAISHA curriculum, delivered over 20 weeks (n = 33); or, to no intervention (n = 33). Study participants are interviewed at baseline and at 24 months post-intervention about their: household; partner; income; health; attitudes and social norms; relationship (including experiences of different forms of violence); childhood; and community. For the qualitative study and process evaluation, focus group discussions are being conducted with study participants and MAISHA curriculum facilitators. In-depth interviews are being conducted with a purposive sample of 18 participants. The primary outcome, assessed at 24 months post-intervention, is a composite of women's reported experience of physical and/or sexual IPV during the past 12 months. Secondary outcomes include: reported experience of physical, sexual and emotional/psychological IPV during the past 12 months, attitudes towards IPV and reported disclosure of IPV to others.
DISCUSSION


The study forms part of a wider programme of research (MAISHA) that includes: a complementary cluster RCT evaluating the impact of delivering the MAISHA curriculum to women not receiving formal group-based microfinance; an economic evaluation; and a cross-sectional survey of men to explore male risk factors associated with IPV. MAISHA will generate rigorous evidence on violence prevention interventions, as well as further insights into the different forms and consequences of violence and drivers of violence perpetration.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT02592252 , registered retrospectively on 13 August 2015.",2018,"The primary outcome, assessed at 24 months post-intervention, is a composite of women's reported experience of physical and/or sexual IPV during the past 12 months.","['Study participants are interviewed at baseline and at 24\xa0months post-intervention about their: household; partner; income; health; attitudes and social norms; relationship (including experiences of different forms of violence); childhood; and community', 'women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01', 'Sixty-six eligible microfinance loan groups', ""women's past year experience of physical and/or sexual IPV of a participatory gender training curriculum (MAISHA curriculum) delivered to women participating in group-based microfinance in Tanzania"", 'women who have been in a relationship have experienced physical and/or sexual violence from an intimate partner']","['MAISHA curriculum to women not receiving formal group-based microfinance', '10-session participatory gender training curriculum']","[' reported experience of physical, sexual and emotional/psychological IPV during the past 12\xa0months, attitudes towards IPV and reported disclosure of IPV to others', 'intimate partner violence', ""composite of women's reported experience of physical and/or sexual IPV""]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0699756', 'cui_str': 'Intimate (qualifier value)'}]","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",18.0,0.115763,"The primary outcome, assessed at 24 months post-intervention, is a composite of women's reported experience of physical and/or sexual IPV during the past 12 months.","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK. sheila.harvey@lshtm.ac.uk.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Lees', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Mshana', 'Affiliation': 'National Institute for Medical Research, PO Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pilger', 'Affiliation': 'Mwanza Intervention Trials Unit, PO Box 11936, Mwanza, Tanzania.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Mwanza Intervention Trials Unit, PO Box 11936, Mwanza, Tanzania.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, PO Box 11936, Mwanza, Tanzania.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}]",BMC women's health,['10.1186/s12905-018-0546-8']
1245,29637421,The Efficacy of a Universal School-Based Prevention Program for Eating Disorders among German Adolescents: Results from a Randomized-Controlled Trial.,"Disordered eating is highly prevalent during adolescence and has a detrimental effect on further development. Effective prevention programs are needed to prevent unhealthy developmental trajectories. This study evaluated the efficacy of the POPS-program (POtsdam Prevention at Schools), a universal school-based eating disorder prevention program for adolescents. In a cluster-randomized design, we compared the intervention group receiving the prevention program to a waiting control group. Outcomes included indicators of disordered eating and relevant risk factors for eating disorders (body dissatisfaction, internalization of the thin ideal, perceived media pressure, perfectionism, emotional element of exercise, social comparison, and perceived teasing). Questionnaires were administered at the start of the intervention, 3 and 12 months post intervention. At baseline, 1112 adolescents aged 10 to 16 years participated (49% girls; 51% intervention group). Intention-to-treat analyses with the complete data set and per-protocol analyses as a completer analysis were performed. The intervention group showed a more favorable course compared to the control group regarding all observed risk factors for eating disorders except for perceived teasing. Effect sizes were small but comparable to other primary prevention programs. At 1-year follow-up, a small but significant effect on disordered eating was observed. Results of the per-protocol analyses were mostly confirmed by the intention-to-treat analyses. Results were promising for both genders although girls benefited more regarding disordered eating and internalization of the thin ideal. Further studies are warranted examining successful program elements and whether gender-specific programs are needed.",2018,The intervention group showed a more favorable course compared to the control group regarding all observed risk factors for eating disorders except for perceived teasing.,"['Eating Disorders among German Adolescents', '1112 adolescents aged 10 to 16 years participated (49% girls; 51% intervention group', 'adolescents']","['universal school-based eating disorder prevention program', 'Universal School-Based Prevention Program', 'POPS-program (POtsdam Prevention at Schools', 'intervention group receiving the prevention program to a waiting control group']","['disordered eating and relevant risk factors for eating disorders (body dissatisfaction, internalization of the thin ideal, perceived media pressure, perfectionism, emotional element of exercise, social comparison, and perceived teasing', 'disordered eating']","[{'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",1112.0,0.0459013,The intervention group showed a more favorable course compared to the control group regarding all observed risk factors for eating disorders except for perceived teasing.,"[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Warschburger', 'Affiliation': 'Department of Psychology, University of Potsdam, Karl-Liebknecht-Str. 24-25, Potsdam, 14476, Germany. warschb@uni-potsdam.de.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Zitzmann', 'Affiliation': 'Department of Psychology, University of Potsdam, Karl-Liebknecht-Str. 24-25, Potsdam, 14476, Germany.'}]",Journal of youth and adolescence,['10.1007/s10964-018-0852-3']
1246,31876907,Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial.,"AIMS


To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence.
METHODS AND RESULTS


This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm.
CONCLUSION


In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected.
CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER


NCT01813435.",2020,No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952).,"['treated patients undergoing', 'patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD']","['percutaneous coronary intervention', 'ticagrelor', 'aspirin monotherapy', 'ticagrelor monotherapy']","['2-year clinical outcomes', 'COPD and dyspnoea AE', '2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction', 'dyspnoea']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",2101.0,0.320772,No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952).,"[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Spitzer', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Plante', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Hernández Antolin', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Jambrik', 'Affiliation': 'Békés Megyei Pándy Kálmán Kórház County Hospital, Gyula, Hungary.'}, {'ForeName': 'Valeri', 'Initials': 'V', 'LastName': 'Gelev', 'Affiliation': 'Tokuda Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Cardiologie Clinique Valmy Hopital Prive Dijon Bourgogne HPDB Dijon, Dijon, France.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Konteva', 'Affiliation': 'Heart Centre ""Pontica"", Burgas, Bulgaria.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen, Caen, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Morelle', 'Affiliation': 'Clinique St. Martin, Caen, France.'}, {'ForeName': 'Krzysztof J', 'Initials': 'KJ', 'LastName': 'Filipiak', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rademaker-Havinga', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Cardiovascular Science, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Giessen, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université Paris Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz052']
1247,29809030,Are visual cues helpful for virtual spatial navigation and spatial memory in patients with mild cognitive impairment or Alzheimer's disease?,"OBJECTIVE


To evaluate whether visual cues are helpful for virtual spatial navigation and memory in Alzheimer's disease (AD) and patients with mild cognitive impairment (MCI).
METHOD


20 patients with AD, 18 patients with MCI and 20 age-matched healthy controls (HC) were included. Participants had to actively reproduce a path that included 5 intersections with one landmark at each intersection that they had seen previously during a learning phase. Three cueing conditions for navigation were offered: salient landmarks, directional arrows and a map. A path without additional visual stimuli served as control condition. Navigation time and number of trajectory mistakes were recorded.
RESULTS


With the presence of directional arrows, no significant difference was found between groups concerning the number of trajectory mistakes and navigation time. The number of trajectory mistakes did not differ significantly between patients with AD and patients with MCI on the path with arrows, the path with salient landmarks and the path with a map. There were significant correlations between the number of trajectory mistakes under the arrow condition and executive tests, and between the number of trajectory mistakes under the salient landmark condition and memory tests.
CONCLUSION


Visual cueing such as directional arrows and salient landmarks appears helpful for spatial navigation and memory tasks in patients with AD and patients with MCI. This study opens new research avenues for neuro-rehabilitation, such as the use of augmented reality in real-life settings to support the navigational capabilities of patients with MCI and patients with AD. (PsycINFO Database Record",2018,"With the presence of directional arrows, no significant difference was found between groups concerning the number of trajectory mistakes and navigation time.","['patients with MCI and patients with AD', 'Participants had to actively reproduce a path that included 5 intersections with one landmark at each intersection that they had seen previously during a learning phase', ""patients with mild cognitive impairment or Alzheimer's disease"", 'patients with AD and patients with MCI', ""Alzheimer's disease (AD) and patients with mild cognitive impairment (MCI"", '20 patients with AD, 18 patients with MCI and 20 age-matched healthy controls (HC) were included']",['Visual cueing such as directional arrows and salient landmarks'],"['number of trajectory mistakes under the arrow condition and executive tests', 'number of trajectory mistakes under the salient landmark condition and memory tests', 'Navigation time and number of trajectory mistakes', 'number of trajectory mistakes and navigation time', 'number of trajectory mistakes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0336721', 'cui_str': 'Arrow, device (physical object)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0336721', 'cui_str': 'Arrow, device (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.0321903,"With the presence of directional arrows, no significant difference was found between groups concerning the number of trajectory mistakes and navigation time.","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Cogné', 'Affiliation': 'Rehabilitation Unit, University Hospital of Bordeaux.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Auriacombe', 'Affiliation': 'Institut des Maladies Neurodégénératives, University Hospital of Bordeaux.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Vasa', 'Affiliation': 'University of Bordeaux.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Tison', 'Affiliation': 'Institut des Maladies Neurodégénératives, and Neurology Unit, University Hospital of Bordeaux.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Klinger', 'Affiliation': ""Digital Interactions Health and Disability Lab, École Supérieure d'Informatique Electronique Automatique.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Sauzéon', 'Affiliation': 'Institut National de Recherche en Informatique et en Automatique.'}, {'ForeName': 'Pierre-Alain', 'Initials': 'PA', 'LastName': 'Joseph', 'Affiliation': 'Rehabilitation Medicine Unit, University Hospital of Bordeaux.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'N Kaoua', 'Affiliation': 'Institut National de Recherche en Informatique et en Automatique.'}]",Neuropsychology,['10.1037/neu0000435']
1248,29551030,[The efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia].,"Objective:  To investigate the safety and efficacy of eltrombopag for adult patients with chronic immune thrombocytopenia (cITP).  Methods:  It was a randomised, single-centre, 6 weeks, placebo-controlled study. Beginning in January 29(th), 2013, 35 patients were enrolled, and the trial was completed on May 16(th), 2014. 17 patients were assigned to receive eltrombopag (starting dose 25 mg/d) and 18 were assigned to receive placebo.  Results:  A total of 35 cases of adult cITP, 6 males and 29 females with a median age of 42(22-66) years were enrolled. One patient withdrew from eltrombopag treatment group for the adverse event (AE) and discontinued treatment. In first two weeks, 27.78% (5/18) of placebo-treated compared with 64.71%(11/17) of eltrombopag-treated patients achieved platelet counts ≥ 30×10(9)/L( P =0.031); Treatment 6 weeks, the proportion of platelet counts reached ≥50×10(9)/L and ≥ 30×10(9)/L in eltrombopag-treated were higher than placebo-treated ones with statistically significant differences in both groups [64.71%(11/17)  vs  11.11% (2/18),  P =0.001; 76.47% (13/17)  vs  38.89% (7/18),  P =0.028]; The study also indicated a statistically significant difference in favour of eltrombopag compared with placebo in the odds of achieving the outcome of a platelet count ≥ 50×10(9)/L at least once during 6-week treatment (94.11%  vs  33.33%,  P <0.001), and 70.59%(12/17) of patients with the platelet count continuously ≥ 50×10(9)/L in 50% of treatment time in eltrombopag-treated group was more than placebo-treated one [11.11%(2/18),  P <0.001]. Proportions of patients who required rescue treatment were 44.44% in placebo group and none in eltrombopag-treated one, respectively ( P =0.002); The odds of bleeding symptoms with the WHO bleeding scale had no difference in both groups after 6 weeks ( P =0.066). Adverse events that occurred more frequently due to eltrombopag than placebo included increased transaminase (3/17) and blood bilirubin (5/17), cerebral infarction(1/17).  Conclusions:  The thrombopoietin receptor agonist eltrombopag was a suitable therapeutic option for Chinese adults with cITP.",2018,The thrombopoietin receptor agonist eltrombopag was a suitable therapeutic option for Chinese adults with cITP.,"['Chinese patients with chronic immune thrombocytopenia', 'A total of 35 cases of adult cITP, 6 males and 29 females with a median age of 42(22-66) years were enrolled', 'Beginning in January 29(th), 2013, 35 patients were enrolled, and the trial was completed on May 16(th), 2014', 'adult patients with chronic immune thrombocytopenia (cITP', 'Chinese adults with cITP', '17 patients']","['thrombopoietin receptor agonist eltrombopag', 'eltrombopag', 'placebo']","['safety and efficacy', 'Adverse events', 'odds of bleeding symptoms with the WHO bleeding scale', 'efficacy and safety', 'proportion of platelet counts', 'transaminase (3/17) and blood bilirubin (5/17), cerebral infarction(1/17']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4522005', 'cui_str': 'Thrombopoietin receptor agonist'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0863174', 'cui_str': 'Blood bilirubin'}]",35.0,0.275698,The thrombopoietin receptor agonist eltrombopag was a suitable therapeutic option for Chinese adults with cITP.,"[{'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Huang', 'Affiliation': 'Institute of Hematology and Blood Disease Hospital, CAMS & PUMC, Tianjin 300020, China.'}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Yang', 'Affiliation': ''}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2018.01.007']
1249,29683690,Call to claim your prize: Perceived benefits and risk drive intention to comply in a mass marketing scam.,"Mass marketing scams extract an enormous toll, yet the literature on scams is just emerging. In Experiment 1, 211 adults reviewed a solicitation and rated their intention of contacting an ""activation number"" for a prize. Scarcity and authority were manipulated. Many (48.82%) indicated some willingness to contact to ""activate"" the winnings. Intention of responding was inversely related to the perception of risk (b = -.441, p < .001) and positively associated with perception of benefits (b = .554, p < .001), but not with the experimental condition. In Experiment 2, 291 adults were randomly assigned to one of the three conditions (low, medium, or high activation fee), and were asked to report willingness to contact. Activation fees decreased intent to contact, but percentages remained high (25.70%), with higher perception of risk reducing contact rates (b = -.581, p < .001), and benefit perception increasing intent to contact (b = .381, p < .001). Our studies indicate that consumers are responding to perceived risks and benefits in their decision-making, regardless of persuasion elements used by scammers. In summary, our studies find that consumers with lower levels of education and high perception of benefits are at increased risk for mass marketing scams. (PsycINFO Database Record",2018,"Activation fees decreased intent to contact, but percentages remained high (25.70%), with higher perception of risk reducing contact rates (b = -.581, p < .001), and benefit perception increasing intent to contact (b = .381, p < .001).","['211 adults reviewed a solicitation and rated their intention of contacting an ""activation number"" for a prize', '291 adults']",[],['higher perception of risk reducing contact rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0080049', 'cui_str': 'Prizes'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",291.0,0.0245097,"Activation fees decreased intent to contact, but percentages remained high (25.70%), with higher perception of risk reducing contact rates (b = -.581, p < .001), and benefit perception increasing intent to contact (b = .381, p < .001).","[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'Department of Psychology, Scripps College.'}, {'ForeName': 'Pi-Ju', 'Initials': 'PJ', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, University of California, San Francisco.'}, {'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Hanoch', 'Affiliation': 'Department of Psychology, University of Plymouth.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Xi', 'Affiliation': 'Department of Psychology, Claremont Graduate University.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Klapatch', 'Affiliation': 'Department of Psychology, Claremont Graduate University.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000167']
1250,31473600,Oxygen Therapy in Myocardial Infarction Patients With or Without Diabetes: A Predefined Subgroup Analysis From the DETO2X-AMI Trial.,"OBJECTIVE


To determine the effects of oxygen therapy in myocardial infarction (MI) patients with and without diabetes.
RESEARCH DESIGN AND METHODS


In the Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6-12 h or ambient air. In this prespecified analysis involving 5,010 patients with confirmed MI, 934 had known diabetes. Oxidative stress may be of particular importance in diabetes, and the primary objective was to study the effect of supplemental oxygen on the composite of all-cause death and rehospitalization with MI or heart failure (HF) at 1 year in patients with and without diabetes.
RESULTS


As expected, event rates were significantly higher in patients with diabetes compared with patients without diabetes (main composite end point: hazard ratio [HR] 1.60 [95% CI 1.32-1.93],  P  < 0.01). In patients with diabetes, the main composite end point occurred in 16.2% (72 of 445) allocated to oxygen as compared with 16.6% (81 of 489) allocated to ambient air (HR 0.93 [95% CI 0.67-1.27],  P  = 0.81). There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year. Likewise, corresponding end points in patients without diabetes were similar between the treatment groups.
CONCLUSIONS


Despite markedly higher event rates in patients with MI and diabetes, oxygen therapy did not significantly affect 1-year all-cause death, cardiovascular death, or rehospitalization with MI or HF, irrespective of underlying diabetes, in line with the results of the entire study.",2019,There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year.,"['5,010 patients with confirmed MI, 934 had known diabetes', '6,629 normoxemic patients with suspected MI', 'patients with and without diabetes', 'myocardial infarction (MI) patients with and without diabetes', 'Myocardial Infarction Patients With or Without Diabetes']","['oxygen therapy', 'Oxygen Therapy']","['rate of cardiovascular death', 'death, cardiovascular death, or rehospitalization with MI or HF, irrespective of underlying diabetes', 'event rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5010.0,0.135599,There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nyström', 'Affiliation': 'Division of Endocrinology, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Cardiology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Lindahl', 'Affiliation': 'Cardiology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Cardiology, Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Herlitz', 'Affiliation': 'Department of Health Sciences, University of Borås, Borås, Sweden.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital Department of Cardiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mellbin', 'Affiliation': 'Division of Cardiology, Department of Medicine, Solna, Karolinska Institutet, and Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Alfredsson', 'Affiliation': 'Department of Medical and Health Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Cardiology, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0590']
1251,31608934,Effect of the Incretin Hormones on the Endocrine Pancreas in End-Stage Renal Disease.,"CONTEXT


The insulin-stimulating and glucagon-regulating effects of the 2 incretin hormones, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), contribute to maintain normal glucose homeostasis. Impaired glucose tolerance occurs with high prevalence among patients with end-stage renal disease (ESRD).
OBJECTIVE


To evaluate the effect of the incretin hormones on endocrine pancreatic function in patients with ESRD.
DESIGN AND SETTING


Twelve ESRD patients on chronic hemodialysis and 12 matched healthy controls, all with normal oral glucose tolerance test, were included. On 3 separate days, a 2-hour euglycemic clamp followed by a 2-hour hyperglycemic clamp (3 mM above fasting level) was performed with concomitant infusion of GLP-1 (1 pmol/kg/min), GIP (2 pmol/kg/min), or saline administered in a randomized, double-blinded fashion. A 30% lower infusion rate was used in the ESRD group to obtain comparable incretin hormone plasma levels.
RESULTS


During clamps, comparable plasma glucose and intact incretin hormone concentrations were achieved. The effect of GLP-1 to increase insulin concentrations relative to placebo levels tended to be lower during euglycemia in ESRD and was significantly reduced during hyperglycemia (50 [8-72]%, P = 0.03). Similarly, the effect of GIP relative to placebo levels tended to be lower during euglycemia in ESRD and was significantly reduced during hyperglycemia (34 [13-50]%, P = 0.005). Glucagon was suppressed in both groups, with controls reaching lower concentrations than ESRD patients.
CONCLUSIONS


The effect of incretin hormones to increase insulin release is reduced in ESRD, which, together with elevated glucagon levels, could contribute to the high prevalence of impaired glucose tolerance among ESRD patients.",2020,"The effect of GLP-1 to increase insulin concentrations relative to placebo levels tended to be lower during euglycaemia in ESRD and was significantly reduced during hyperglycaemia (50 [8-72]%, P=0.03).","['end-stage renal disease', 'patients with ESRD', 'and Setting: Twelve ESRD patients on chronic haemodialysis and 12 matched healthy controls, all with normal oral glucose tolerance test, were included', 'patients with end-stage renal disease (ESRD']","['GIP (2 pmol/kg/min) or saline', 'incretin hormones', 'euglycaemic clamp followed by a 2 h hyperglycaemic clamp']","['plasma glucose and intact incretin hormone concentrations', 'hyperglycaemia', 'Glucagon', 'Impaired glucose tolerance (IGT', 'endocrine pancreatic function']","[{'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}]",,0.0990271,"The effect of GLP-1 to increase insulin concentrations relative to placebo levels tended to be lower during euglycaemia in ESRD and was significantly reduced during hyperglycaemia (50 [8-72]%, P=0.03).","[{'ForeName': 'Morten B', 'Initials': 'MB', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Rydahl', 'Affiliation': 'Department of Nephrology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Henrik P', 'Initials': 'HP', 'LastName': 'Hansen', 'Affiliation': 'Department of Nephrology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Bressendorff', 'Affiliation': 'Department of Cardiology, Endocrinology and Nephrology, Nordsjællands Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Lisbet', 'Initials': 'L', 'LastName': 'Brandi', 'Affiliation': 'Department of Cardiology, Endocrinology and Nephrology, Nordsjællands Hospital, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Clinical Metabolomics Core Facility, Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'The Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Hornum', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz048']
1252,29474130,"""It's natural and healthy, but I don't want to see it"": Using Entertainment-Education to Improve Attitudes Toward Breastfeeding in Public.","While it has been well established that breastfeeding provides the best nourishment for children, few women achieve the recommended breastfeeding duration. Negative media messages have been identified as one explanation for the lack of individual and public support for breastfeeding. This study explored the influence of media on the knowledge and attitudes of a nearly childless population to ascertain if and how entertainment media can positively impact perceptions of breastfeeding. Using cultivation and parasocial interaction, this research measured entertainment television's effect on breastfeeding attitudes using randomized-group experiments involving 375 students. Overall, participants generally held positive attitudes but were uncomfortable seeing breastfeeding. Moreover, results indicate that viewing a prime-time television clip that depicted public breastfeeding not only significantly lessened the extent to which participants believed that breastfeeding was a private activity but also improved attitudes and support for breastfeeding in public. This study concludes that more pro-breastfeeding media messages in entertainment media could help create a climate conducive to breastfeeding success.",2019,"Moreover, results indicate that viewing a prime-time television clip that depicted public breastfeeding not only significantly lessened the extent to which participants believed that breastfeeding was a private activity but also improved attitudes and support for breastfeeding in public.",['375 students'],[],['Attitudes'],"[{'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}]",375.0,0.0135692,"Moreover, results indicate that viewing a prime-time television clip that depicted public breastfeeding not only significantly lessened the extent to which participants believed that breastfeeding was a private activity but also improved attitudes and support for breastfeeding in public.","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Foss', 'Affiliation': 'a School of Journalism , Middle Tennessee State University.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'a School of Journalism , Middle Tennessee State University.'}]",Health communication,['10.1080/10410236.2018.1440506']
1253,31635815,"Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo.","BACKGROUND


Mirabegron, a β3-adrenoreceptor agonist, is an alternative drug to antimuscarinics for overactive bladder (OAB) symptoms.
OBJECTIVE


To summarise safety and efficacy reporting of mirabegron treatment for OAB symptoms.
DESIGN, SETTING, AND PARTICIPANTS


Pooled data analysed from 10 phase 2-4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug.
INTERVENTION


Mirabegron: 25 and 50mg; antimuscarinics: solifenacin (2.5, 5, and 10mg) and tolterodine extended release (4mg).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age (<65 vs ≥65yr and <75 vs ≥75yr) and sex were assessed. Solifenacin 2.5 and 10mg groups were not included in the efficacy analyses (small patient numbers). Safety was evaluated using the proportion of treatment-emergent adverse events. Efficacy variables were derived from bladder diaries (baseline and week 12).
RESULTS AND LIMITATIONS


Baseline hypertension and diabetes were more frequent across treatment groups in the older versus younger age groups and in men versus women. Within sexes, frequencies were similar between treatment groups. Some differences were observed in baseline characteristics, including type of incontinence and medical history between sexes. No previously unreported safety concerns were identified. Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups. Significant treatment-by-subgroup interactions included change from baseline in the mean number of incontinence episodes/24h by age (<65 vs ≥65yr), nocturia by age (<65 vs ≥65yr and <75 vs ≥75yr), and urgency episodes by previous OAB medication.
CONCLUSIONS


Data from this integrated database of 10 mirabegron studies reaffirm the safety and efficacy profiles of mirabegron, solifenacin, and tolterodine in adults of different age groups and sexes.
PATIENT SUMMARY


Overactive bladder is a complex of symptoms including a compelling desire to pass urine that leads to increased frequency, which may lead to a degree of incontinence if you do not reach the toilet in time and may wake you from sleep. We pooled data from 10 different studies of mirabegron in patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women. No new safety concerns were identified, and mirabegron improved the symptoms of overactive bladder.",2020,"Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups.","['Pooled data analysed from 10 phase 2-4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug', 'adults of different age groups and sexes', 'patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women', 'Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or']","['Placebo', 'antimuscarinics: solifenacin', 'Mirabegron', 'placebo', 'tolterodine extended release (4mg', 'Solifenacin']","['symptoms of overactive bladder', 'efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes', 'Safety', 'nocturia', 'Baseline hypertension and diabetes', 'Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age ']","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0595947', 'cui_str': 'Extrinsic (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.124115,"Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Chapple', 'Affiliation': 'Royal Hallamshire Hospital, Sheffield, UK. Electronic address: c.r.chapple@sheffield.ac.uk.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cruz', 'Affiliation': 'Department of Urology, Faculty of Medicine, Hospital S João, Porto, Portugal; I3S Institute, Porto, Portugal.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cardozo', 'Affiliation': ""Department of Urogynaecology, King's College Hospital, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Urology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Astellas Pharma Europe Ltd., Chertsey, Surrey, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stoelzel', 'Affiliation': 'Department of Data Science, Astellas Pharma Europe, Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Global Medical Affairs, Astellas Pharma, Chertsey, UK.'}]",European urology,['10.1016/j.eururo.2019.09.024']
1254,29507743,"Effect of transporting an evidence-based, violence prevention intervention to Jamaican preschools on teacher and class-wide child behaviour: a cluster randomised trial.","Introduction


Based on extensive piloting work, we adapted the Incredible Years (IY) teacher-training programme to the Jamaican preschool setting and evaluated this adapted version through a cluster-randomised trial.
Methods


Twenty-four community preschools in Kingston, Jamaica were randomly assigned to intervention (12 schools, 37 teachers) or control (12 schools, 36 teachers). The intervention involved training teachers in classroom management through eight full-day training workshops and four individual 1-h in-class support sessions. Outcome measurements included direct observation of teachers' positive and negative behaviours to the whole class and to high-risk children and four observer ratings: two measures of class-wide child behaviour and two measures of classroom atmosphere. Measures were repeated at a six-month follow-up.
Results


Significant benefits of intervention were found for teachers' positive [effect size (ES) = 3.35] and negative (ES = 1.29) behaviours to the whole class and to high-risk children (positive: ES = 0.83; negative: ES = 0.50) and for observer ratings of class-wide child behaviour (ES = 0.73), child interest and enthusiasm (ES = 0.98), teacher warmth (ES = 2.03) and opportunities provided to share and help (ES = 5.72). At 6-month follow-up, significant benefits of intervention were sustained: positive behaviours (ES = 2.70), negative behaviours (ES = 0.98), child behaviour (ES = 0.50), child interest and enthusiasm (ES = 0.78), teacher warmth (ES = 0.91), opportunities to share and help (ES = 1.42).
Conclusions


The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up. Benefits were of a similar magnitude to those found in a pilot study of the minimally adapted version that required significantly more in-class support for teachers.",2018,"The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up.","['Jamaican preschools on teacher and class-wide child behaviour', 'Methods\n\n\nTwenty-four community preschools in Kingston, Jamaica were randomly assigned to intervention (12 schools, 37 teachers) or control (12 schools, 36 teachers']","['violence prevention intervention', 'intervention involved training teachers in classroom management through eight full-day training workshops and four individual 1-h in-class support sessions']","[""direct observation of teachers' positive and negative behaviours to the whole class and to high-risk children and four observer ratings: two measures of class-wide child behaviour and two measures of classroom atmosphere"", 'negative behaviours (ES = 0.98), child behaviour (ES = 0.50), child interest and enthusiasm (ES = 0.78), teacher warmth']","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022337', 'cui_str': 'Jamaica'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0424090', 'cui_str': 'Level of interest (observable entity)'}, {'cui': 'C4517480', 'cui_str': 'Zero point seven eight'}]",37.0,0.0243866,"The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Baker-Henningham', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Caribbean Institute for Health Research, University of the West Indies, Kingston §7, Jamaica.'}]","Global mental health (Cambridge, England)",['10.1017/gmh.2017.29']
1255,29482372,Effects of a Personal Narrative in Messages Designed to Promote Healthy Fish Consumption Among Women of Childbearing Age.,"Women of childbearing age (WCBA) can attain health benefits of fish consumption while minimizing risks by following state and federal fish consumption guidelines, but many women avoid fish out of concerns about mercury exposure. This study tested the impact of brochures, informed by communication theory and research, to promote healthy fish consumption among licensed female anglers. We conducted a randomized, two-wave longitudinal experiment between May 2014 and September 2015 among 1,135 women ages 18-48 years (at baseline), drawn from a sample of licensed anglers in the Great Lakes region of the United States. We randomly assigned women to one of five groups, to either be sent one of four brochures in spring 2015 using a two (including a short personal narrative or not) by two (using certain or uncertain language) factorial design, or to a no-exposure control arm. Participants reported their fish consumption in summer 2014 and summer 2015 via an online diary. Exposure to brochure versions that included a short personal narrative helped move women whose baseline levels of fish consumption were furthest from federal recommendations closer to these guidelines; effects were clearest among women confirmed, by self-report or web tracking, to have seen the brochure. Narratives hold promise as a strategy to communicate effectively about the benefits of healthy fish consumption and risks of overconsumption among WCBA, but widespread dissemination may be necessary to achieve these effects.",2019,"Exposure to brochure versions that included a short personal narrative helped move women whose baseline levels of fish consumption were furthest from federal recommendations closer to these guidelines; effects were clearest among women confirmed, by self-report or web tracking, to have seen the brochure.","['healthy fish consumption among licensed female anglers', 'Women of childbearing age (WCBA', 'May 2014 and September 2015 among 1,135 women ages 18-48\xa0years (at baseline), drawn from a sample of licensed anglers in the Great Lakes region of the United States', 'Women of Childbearing Age']","['short personal narrative or not) by two (using certain or uncertain language) factorial design, or to a no-exposure control arm', 'Personal Narrative in Messages Designed to Promote Healthy Fish Consumption']",[],"[{'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0600664', 'cui_str': 'Personal Narratives'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",[],,0.119238,"Exposure to brochure versions that included a short personal narrative helped move women whose baseline levels of fish consumption were furthest from federal recommendations closer to these guidelines; effects were clearest among women confirmed, by self-report or web tracking, to have seen the brochure.","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'a Department of Communication , Cornell University.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Connelly', 'Affiliation': 'b Department of Natural Resources , Cornell University.'}, {'ForeName': 'T Bruce', 'Initials': 'TB', 'LastName': 'Lauber', 'Affiliation': 'b Department of Natural Resources , Cornell University.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Knuth', 'Affiliation': 'b Department of Natural Resources , Cornell University.'}]",Health communication,['10.1080/10410236.2018.1437526']
1256,31553410,Effect of 1 or 2 Doses of Inclisiran on Low-Density Lipoprotein Cholesterol Levels: One-Year Follow-up of the ORION-1 Randomized Clinical Trial.,"Importance


Sustained reductions in low-density lipoprotein cholesterol (LDL-C) with lipid-lowering therapies that require frequent dosing are reliant on patient adherence, and poor adherence is associated with worse clinical outcomes.
Objective


To determine whether inclisiran, a small interfering RNA, reduces mean LDL-C exposure with an infrequent dosing regimen.
Design, Setting, and Participants


Prespecified analysis of a randomized, double-blind, placebo-controlled multicenter phase 2 clinical trial. Participants were followed up monthly for LDL-C levels and proprotein convertase subtilisin-kexin type 9 (PCSK9) measurements as well as safety until their LDL-C levels had returned to within 20% of their change from baseline (maximum 360 days). The study included patients with elevated LDL-C despite maximally tolerated statin therapy. Data were analyzed between January 11, 2016, and June 7, 2017.
Interventions


One dose (200, 300, or 500 mg on day 1) or 2 doses (100, 200, or 300 mg on days 1 and 90) of inclisiran sodium or placebo.
Main Outcomes and Measures


Duration of time to return to within 20% of change from baseline for LDL-C levels and time-averaged LDL-C reductions over 1 year.
Results


At baseline, among the 501 participants, 65% were men (n = 326 of 501), mean age was 63 years, 6% had familial hypercholesterolemia (n = 28 of 501), and 69% had established ASCVD (n = 347 of 501). Baseline LDL-C was 128 mg/dL among 501 randomized participants. The percentage of participants who were followed up to day 360 because their LDL-C levels had not returned to within 20% of their change from baseline ranged from 48.3% to 65.0% for those receiving a single dose and between 55.9% and 83.1% of those receiving 2 doses, with similar effects observed for PCSK9. Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses. The 2-dose 300-mg regimen produced the highest proportion of responders at day 360 and the greatest mean reduction in LDL-C over 1 year. Incidence of adverse events was similar through to 1 year.
Conclusions and Relevance


Treatment with inclisiran resulted in durable reductions in LDL-C over 1 year. Inclisiran may offer a novel approach to LDL-C reduction with the convenience of infrequent dosing.
Trial Registration


ClinicalTrials.gov identifier: NCT02597127.",2019,Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses.,"['501 participants, 65% were men (n\u2009=\u2009326 of 501), mean age was 63 years, 6% had familial hypercholesterolemia (n\u2009=\u200928 of 501), and 69% had established ASCVD (n\u2009=\u2009347 of 501', 'patients with elevated LDL-C despite maximally tolerated statin therapy']","['placebo', 'inclisiran sodium or placebo', 'Inclisiran']","['safety until their LDL-C levels', 'Incidence of adverse events', 'low-density lipoprotein cholesterol (LDL-C', 'Measures\n\n\nDuration of time to return to within 20% of change from baseline for LDL-C levels and time-averaged LDL-C reductions', 'LDL-C levels', 'Low-Density Lipoprotein Cholesterol Levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4307388', 'cui_str': 'inclisiran'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",501.0,0.524868,Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses.,"[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, Charing Cross Hospital, London, England.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Stoekenbroek', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kallend', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Nishikido', 'Affiliation': 'Cardiovascular Medicine, Saga University, Nabeshima, Saga, Japan.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Charité-Universitats medizin Berlin, Berlin, Germany.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Wright', 'Affiliation': 'Department of Cardiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter L J', 'Initials': 'PLJ', 'LastName': 'Wijngaard', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'University of Amsterdam, Amsterdam, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.3502']
1257,29566739,Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial.,"BACKGROUND


The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART.
METHODS


The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health's Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women's health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively.
DISCUSSION


The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015.",2018,"We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual).","['adults on lifelong ART', '2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9', 'adults receiving antiretroviral therapy in South Africa', '19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015', '40 clinics across two rural districts of the North West Province of South Africa']",[],"['PHQ-9 scores', 'viral load suppression rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",[],"[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",,0.204148,"We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual).","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Fairall', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa. lara.fairall@uct.ac.za.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Babalwa', 'Initials': 'B', 'LastName': 'Zani', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Folb', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Georgeu-Pepper', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Selohilwe', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Ruwayda', 'Initials': 'R', 'LastName': 'Petrus', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Ntokozo', 'Initials': 'N', 'LastName': 'Mntambo', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Department of Population Health and Primary Care, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hanass-Hancock', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Cuncil, Durban, South Africa.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Carmona', 'Affiliation': 'Department of Molecular Medicine and Haematology, University of the Witwatersrand, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gaziano', 'Affiliation': ""Cardiovascular Medicine, Brigham & Women's Hospital, Boston, USA.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Levitt', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tasneem', 'Initials': 'T', 'LastName': 'Kathree', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-018-2517-7']
1258,31629615,Improving burn surgery education for medical students in China.,"INTRODUCTION


In China, although burn treatment develops rapidly, and ranks in the forefront of the world, there is a relative shortage of burn specialists, which limits the development of burn education. In traditional curriculum of surgery education, burn surgery education accounts for few proportions, which results in the indifference to the burn surgery among medical students. To date, few research reported the application of Clinical pathway- Problem based Learning (CP-PBL) in burn surgery education. The objective of the study is to explore the teaching effect of this novel teaching method in burn surgery education.
METHODS


A pilot study was performed. One hundred and six students were randomly divided into a Lecture based Learning (LBL) only group (control group) and a LBL combined Clinical pathway- Problem based Learning group (observation group). A set of test was designed as evaluation criteria based on questions of burn surgery in National Medical Licensing Examination (NMLE) from 2011 to 2018.
RESULTS


The students with Clinical pathway- Problem based Learning had better academic performances in profession theory. Type A2 and Type A3/A4 scores in the observation group were higher than those in the control group (p < 0.05). The scores of the observation group were higher than those of control group in the domains of understanding and application (p < 0.05). They also have higher favorable impressions of learning experience.
CONCLUSIONS


More active approaches yield more learning and are viewed more favorable, which provides a vital message for the evolution of curriculum in Chinese medical schools.",2020,Type A2 and Type A3/A4 scores in the observation group were higher than those in the control group (p < 0.05).,"['One hundred and six students', 'burn surgery in National Medical Licensing Examination (NMLE) from 2011 to 2018', 'students with Clinical pathway- Problem based Learning had better academic performances in profession theory', 'medical students in China']",['Lecture based Learning (LBL) only group (control group) and a LBL combined Clinical pathway- Problem based Learning group (observation group'],[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0242373', 'cui_str': 'Licensing'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],,0.0232826,Type A2 and Type A3/A4 scores in the observation group were higher than those in the control group (p < 0.05).,"[{'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Shengjing\u2009Hospital\u2009of\u2009China\u2009Medical\u2009University, No.36 Sanhao Street, Heping District, Shenyang, 110004, China. Electronic address: yaopin@sj-hospital.org.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'OuYang', 'Affiliation': 'Humanity and Management College of Shaanxi University of Chinese Medicine, China, Xixian Big Road, Xixian New District, Shanxi Province, 712046, China. Electronic address: 303188490@qq.com.'}, {'ForeName': 'Chunping', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Administration School, Hainan Medical University, China, No. 3 Xueyuan Road, Longhua Area, Haikou, Hainan Province, 571199, China. Electronic address: 956894529@qq.com.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'College of the Humanities and Social Sciences, China Medical University, No.77 Puhe Road, Shenyang North New Area, Shenyang, 110122, China. Electronic address: 1134854137@qq.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'College of the Humanities and Social Sciences, China Medical University, No.77 Puhe Road, Shenyang North New Area, Shenyang, 110122, China. Electronic address: wxinsmile@qq.com.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Burns, The First Affiliated Hospital of China Medical University, No.155 Nanjing Road, Heping District, Shenyang, Liaoning Province, 110001, China. Electronic address: 985653404@qq.com.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.09.012']
1259,31629546,Estimation of the Risk of Lung Cancer in Women Participating in a Population-Based Breast Cancer Screening Program.,"INTRODUCTION


Lung cancer mortality is increasing in women. In Spain, estimates suggest that lung cancer mortality may soon surpass breast cancer mortality, the main cause of cancer mortality among women. The aim of this study was to estimate the proportion of women at high risk of developing lung cancer in a group of participants in a population-based breast cancer screening program.
METHODS


Cross-sectional study in a sample of women who participated in a population-based breast cancer screening program in 2016 in Hospitalet de Llobregat (n=1,601). High risk of lung cancer was defined according to the criteria of the National Lung Screening Trial (NLST) and the Dutch-Belgian randomized lung cancer screening trial (NELSON).
RESULTS


Around 20% of smokers according to NLST criteria and 40% of smokers according to NELSON criteria, and around 20% of former smokers according to both criteria, are at high risk of developing lung cancer. A positive and statistically significant trend is observed between the proportion of women at high risk and nicotine dependence measured with the brief Fagerström test.
CONCLUSIONS


A high proportion of participants in this breast cancer screening program have a high risk of developing lung cancer and would be eligible to participate in a lung cancer screening program. Population-based breast cancer screening programs may be useful to implement lung cancer primary prevention activities.",2020,"A positive and statistically significant trend is observed between the proportion of women at high risk and nicotine dependence measured with the brief Fagerström test.
","['Women Participating in a Population-Based Breast Cancer Screening Program', 'women at high risk of developing lung cancer in a group of participants in a population-based breast cancer screening program', 'Cross-sectional study in a sample of women who participated in a population-based breast cancer screening program in 2016 in Hospitalet de Llobregat (n=1,601', 'women']",[],"['Risk of Lung Cancer', 'High risk of lung cancer']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]",,0.036676,"A positive and statistically significant trend is observed between the proportion of women at high risk and nicotine dependence measured with the brief Fagerström test.
","[{'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'González-Marrón', 'Affiliation': 'Group of Evaluation of Health Determinants and Health Policies, Universitat Internacional de Catalunya, SantCugat del Vallès, España.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Martín-Sánchez', 'Affiliation': 'Group of Evaluation of Health Determinants and Health Policies, Universitat Internacional de Catalunya, SantCugat del Vallès, España.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Garcia-Alemany', 'Affiliation': ""Screening Cancer Unit, Cancer Prevention and Control Program, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, España.""}, {'ForeName': 'Encarna', 'Initials': 'E', 'LastName': 'Martínez-Martín', 'Affiliation': ""Screening Cancer Unit, Cancer Prevention and Control Program, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, España.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Matilla-Santander', 'Affiliation': 'Group of Evaluation of Health Determinants and Health Policies, Universitat Internacional de Catalunya, SantCugat del Vallès, España.'}, {'ForeName': 'Àurea', 'Initials': 'À', 'LastName': 'Cartanyà-Hueso', 'Affiliation': 'Group of Evaluation of Health Determinants and Health Policies, Universitat Internacional de Catalunya, SantCugat del Vallès, España.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': ""Screening Cancer Unit, Cancer Prevention and Control Program, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, España.""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'García', 'Affiliation': ""Screening Cancer Unit, Cancer Prevention and Control Program, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, España.""}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Martínez-Sánchez', 'Affiliation': 'Group of Evaluation of Health Determinants and Health Policies, Universitat Internacional de Catalunya, SantCugat del Vallès, España; Cancer Epidemiology and Cancer Prevention Program, T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: jmmartinez@uic.es.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2019.04.014']
1260,29504791,Maternal patterns of antenatal and postnatal depressed mood and the impact on child health at 3-years postpartum.,"OBJECTIVE


The consequences of maternal depressed mood on children's growth, health, and cognitive and language development are examined over the first 3 years of life.
METHOD


Pregnant women in 24 periurban township neighborhoods in Cape Town, South Africa (N = 1,238 mothers) were randomized by neighborhood to a home visiting intervention or a standard care condition. Reassessments were conducted for 93%-85% of mothers at 2-weeks, 6-, 18-, and 36-months postbirth. Regressions were conducted on measures of children's growth, behavior, language, and cognition to examine the impact of four patterns of depressed mood: antenatal only (n = 154, 13.8%), postnatal only (n = 272, 24.3%), antenatal and postnatal (n = 220, 19.7%), and no depressed mood on any assessment (n = 473, 42.3%).
RESULTS


Patterns of depressed mood were similar across intervention conditions. Depressed mothers were significantly less educated, had lower incomes, were less likely to be employed or to have electricity; were more likely to report problematic drinking of alcohol, experience food insecurity, interpersonal partner violence, and to be HIV seropositive. At 36 months, the pattern of maternal depressed mood over time was significantly associated with children's compromised physical growth, both in weight and height, and more internalizing and externalizing symptoms of behavior problems. Measures of language and cognition were similar across maternal patterns of depressed mood.
CONCLUSIONS


Mothers who report depressed mood face significantly more life challenges, both environmental stressors related to poverty and other problematic behaviors. More proximal, postnatal depressed mood appears to have a larger influence on their children, compared with antenatal depressed mood. (PsycINFO Database Record",2018,"At 36 months, the pattern of maternal depressed mood over time was significantly associated with children's compromised physical growth, both in weight and height, and more internalizing and externalizing symptoms of behavior problems.","['Pregnant women in 24 periurban township neighborhoods in Cape Town, South Africa (N = 1,238 mothers', 'only (n = 154, 13.8%), postnatal only (n = 272, 24.3%), antenatal and postnatal (n = 220, 19.7%), and no depressed mood on any assessment (n = 473, 42.3']",['neighborhood to a home visiting intervention or a standard care condition'],"['language and cognition', 'physical growth, both in weight and height, and more internalizing and externalizing symptoms of behavior problems', ""children's growth, behavior, language, and cognition to examine the impact of four patterns of depressed mood: antenatal""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]",1238.0,0.0175886,"At 36 months, the pattern of maternal depressed mood over time was significantly associated with children's compromised physical growth, both in weight and height, and more internalizing and externalizing symptoms of behavior problems.","[{'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Rotheram-Fuller', 'Affiliation': ""Division of Education Leadership and Innovation, Mary Lou Fulton Teacher's College, Arizona State University.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Psychology, Stellenbosch University.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Scheffler', 'Affiliation': 'The Global Center for Children and Families, Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California at Los Angeles.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Weichle', 'Affiliation': 'The Global Center for Children and Families, Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California at Los Angeles.'}, {'ForeName': 'Panteha', 'Initials': 'P', 'LastName': 'Hayati Rezvan', 'Affiliation': 'The Global Center for Children and Families, Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California at Los Angeles.'}, {'ForeName': 'Warren Scott', 'Initials': 'WS', 'LastName': 'Comulada', 'Affiliation': 'The Global Center for Children and Families, Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California at Los Angeles.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'The Global Center for Children and Families, Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California at Los Angeles.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000281']
1261,31618177,Acute effects of essential oil blend containing phlai oil on mood among healthy male volunteers: Randomized controlled trial.,"Background Essential oil blend (ESOB) containing Zingiber montanum or Phlai and Zingiber tenuiscapus oils as the major components has high levels of terpenes such as sabinene, terpinene, terpinolene, and terpine-4-ol. Phlai is well known for its analgesic property, but its effects on mood remain unclear. This study aimed to investigate the acute effects of inhaling the ESOB containing phlai essential oils on mood and stress among healthy volunteers. Methods A prospective, randomized, double-blinded, controlled trial pilot study was conducted among 38 healthy male volunteers; 19 in the ESOB containing phlai oil group and 19 in the control group, which used olive oil. One single inhalation was provided continuously for 15 min via hot steam. Mood status was assessed pre- and post-intervention using the Visual Analog Scales for Mood, Anxiety, Stress and Alertness (MASA). Rorschach tests, in a modified analysis, were also employed. One-way ANCOVA was used to determine statistical differences of the mood test results between ESOB containing phlai oil and olive oil. Results Mean age of the participants was 22.11 (SD 2.1) years. Both ESOB containing phlai oil and olive oil increased the post-test scores of positive mood and reduced the scores of negative mood. However, no difference was observed regarding the mood test scores between groups, except concerning the Rorschach stress test (F (1,38)=6.486, p=0.015). The variance of change, explained by the model (R square), was 32.8%, while the adjusted R-squared was 0.290. Conclusions Single inhalation aromatherapy using ESOB containing phlai oil or olive oil showed an immediate improvement of mood states among healthy young male volunteers by easing the negative emotions and enhancing positive emotions, especially feelings of pleasure and contentment. Natural blend of phlai essential oils was more efficacious than olive oil in reducing emotional stress.",2019,"However, no difference was observed regarding the mood test scores between groups, except concerning the Rorschach stress test (F (1,38)=6.486, p=0.015).","['38 healthy male volunteers; 19 in the ESOB containing phlai oil group and 19 in the control group, which used olive oil', 'healthy young male volunteers', 'healthy male volunteers', 'Mean age of the participants was 22.11 (SD 2.1) years', 'healthy volunteers']","['ESOB containing phlai essential oils', 'ESOB containing phlai oil or olive oil', 'essential oil blend containing phlai oil', ' Essential oil blend (ESOB) containing Zingiber montanum or Phlai and Zingiber tenuiscapus oils', 'olive oil', 'ESOB containing phlai oil and olive oil']","['emotional stress', 'mood test scores', 'Mood status', 'Visual Analog Scales for Mood, Anxiety, Stress and Alertness (MASA', 'scores of negative mood', 'mood states', 'mood and stress']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0086209', 'cui_str': 'Emotional Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0622231', 'cui_str': 'MASA'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",38.0,0.156993,"However, no difference was observed regarding the mood test scores between groups, except concerning the Rorschach stress test (F (1,38)=6.486, p=0.015).","[{'ForeName': 'Warangkana', 'Initials': 'W', 'LastName': 'Arpornchayanon', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sumittra', 'Initials': 'S', 'LastName': 'Gomonchareonsiri', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Chansakaow', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Tinakon', 'Initials': 'T', 'LastName': 'Wongpakaran', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pairada', 'Initials': 'P', 'LastName': 'Varnado', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nahathai', 'Initials': 'N', 'LastName': 'Wongpakaran', 'Affiliation': 'Psychiatry, Chiang Mai University, 110 Intawaroros Rd., Chiang Mai 50200, Thailand.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0097']
1262,31626692,"Predictors and Clinical Outcomes of Poor Platelet Recovery in Adult Dengue With Thrombocytopenia: A Multicenter, Prospective Study.","BACKGROUND


Platelet transfusion is common in dengue patients with thrombocytopenia. We previously showed in a randomized clinical trial that prophylactic platelet transfusion did not reduce clinical bleeding. In this study, we aimed to characterize the predictors and clinical outcomes of poor platelet recovery in transfused and nontransfused participants.
METHODS


We analyzed patients from the Adult Dengue Platelet Study with laboratory-confirmed dengue with ≤20 000 platelets/μL and without persistent mild bleeding or any severe bleeding in a post hoc analysis. Poor platelet recovery was defined as a platelet count of ≤20 000/μL on Day 2. We recruited 372 participants from 5 acute care hospitals located in Singapore and Malaysia between 29 April 2010 and 9 December 2014. Of these, 188 were randomly assigned to the transfusion group and 184 to the control group.
RESULTS


Of 360 patients, 158 had poor platelet recovery. Age, white cell count, and day of illness at study enrollment were significant predictors of poor platelet recovery after adjustment for baseline characteristics and platelet transfusion. Patients with poor platelet recovery had longer hospitalizations but no significant difference in other clinical outcomes, regardless of transfusion. We found a significant interaction between platelet recovery and transfusion; patients with poor platelet recovery were more likely to bleed if given a prophylactic platelet transfusion (odds ratio 2.34, 95% confidence interval 1.18-4.63).
CONCLUSIONS


Dengue patients with thrombocytopenia who were older or presented earlier and with lower white cell counts were more likely to have poor platelet recovery. In patients with poor platelet recovery, platelet transfusion does not improve outcomes and may actually increase the risk of bleeding. The mechanisms of poor platelet recovery need to be determined.
CLINICAL TRIALS REGISTRATION


NCT01030211.",2020,"We found a significant interaction between platelet recovery and transfusion; patients with poor platelet recovery were more likely to bleed if given a prophylactic platelet transfusion (odds ratio 2.34, 95% confidence interval 1.18-4.63).
","['372 participants from 5 acute care hospitals located in Singapore and Malaysia between 29 April 2010 and 9 December 2014', 'dengue patients with thrombocytopenia', 'patients from the Adult Dengue Platelet Study with laboratory-confirmed dengue with ≤20 000 platelets/μL and without persistent mild bleeding or any severe bleeding in a post hoc analysis', 'transfused and nontransfused participants', 'Of 360 patients, 158 had poor platelet recovery', 'Adult Dengue With Thrombocytopenia']",[],"['risk of bleeding', 'Poor platelet recovery', 'clinical bleeding']","[{'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",372.0,0.0749228,"We found a significant interaction between platelet recovery and transfusion; patients with poor platelet recovery were more likely to bleed if given a prophylactic platelet transfusion (odds ratio 2.34, 95% confidence interval 1.18-4.63).
","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Po Ying', 'Initials': 'PY', 'LastName': 'Chia', 'Affiliation': 'Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Sharifah F', 'Initials': 'SF', 'LastName': 'Syed-Omar', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Sasheela S L', 'Initials': 'SSL', 'LastName': 'Ponnampalavanar', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Adeeba', 'Initials': 'A', 'LastName': 'Kamarulzaman', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lucy C S', 'Initials': 'LCS', 'LastName': 'Lum', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tambyah', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Yee-Sin', 'Initials': 'YS', 'LastName': 'Leo', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz850']
1263,29365393,[Efficacy and safety of IA regimen containing different doses of idarubicin in de-novo acute myeloid leukemia for adult patients].,"Objective:  To investigate the efficacy and safety of IA regimen which contains idarubicin (IDA) 8 mg/m(2), 10 mg/m(2) or 12 mg/m(2) as induction chemotherapy for adult patients with de-novo acute myeloid leukemia (AML) .  Methods:  A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China were enrolled in the multicenter, single-blind, non-randomized, clinical controlled study. To compare the response rate of complete remission (CR) , adverse events between different dose idarubicin combined with cytarabine (100 mg/m(2)) as induction chemotherapy in newly diagnosed patients of adult AML.  Results:  Of 1 207 evaluable AML patients were assigned to this analysis of CR rate. The CR rates of IDA 8 mg/m(2) group, IDA 10 mg/m(2) group and IDA 12 mg/m(2) group were 73.6% (215/292) , 84.1% (662/787) and 86.7% (111/128) , respectively ( P <0.001) . After adjusted for age, blast ratio of bone marrow, FAB classification and risk stratification, the odds ratios (95%  CI ) of IDA 10 mg/m(2) group and IDA 12 mg/m(2) group were 0.49 (0.34-0.70) and 0.36 (0.18-0.71) , as compared with the IDA 8 mg/m(2) group ( P <0.001,  P =0.003) . In the intermediate and favorable groups, CR rates was 76.5% (163/213) , 86.9% (506/582) and 86.1% (68/79) in different doses of IDA ( P =0.007) . Interestingly, IA regimen with IDA 10 mg/m(2) was the only beneficial factor affecting CR in this group after adjusted for age, blast ratio of bone marrow and FAB classification[ OR =0.47 (95%  CI  0.31-0.71) ,  P <0.001]. CR rates in adverse group was 50.0% (18/36) , 60.6% (43/71) and 81.8% (18/22) respectively ( P =0.089) . However, the odds ratios (95%  CI ) of IDA 12 mg/m(2) when compared with the IDA 8 mg/m(2) was 0.22 (0.06-0.80) , after adjusted for age, blast ratio of bone marrow and FAB classification. The median time (days) of neutrophil count less than 0.5×10(9)/L in IDA 8 mg/m(2) group, IDA 10 mg/m(2) group and IDA 12 mg/m(2) group were 14 (11-18) , 15 (11-20) and 18 (14-22) , respectively ( P =0.012) and of platelet count lower than 20×10(9)/L were 14 (7-17) , 15 (11-20) and 17 (15-21) , respectively ( P =0.001) . The incidences of lung infection in the three groups were 9.8%, 13.5% and 25.2%, respectively ( P <0.001) .  Conclusions:  For young adult patients (aged 18-60 years) with AML in China, intensifying induction therapy with idarubicin 10 mg/m(2) is clinically superior to IDA 8 mg/m(2) and IDA 12 mg/m(2) in favorable intermediate AML subgroup. However, idarubicin 12 mg/m(2) is more suitable to adverse AML subgroup.",2017,"In the intermediate and favorable groups, CR rates was 76.5% (163/213) , 86.9% (506/582) and 86.1% (68/79) in different doses of IDA ( P =0.007) .","['young adult patients (aged 18-60 years) with AML in China, intensifying induction therapy with', '1 207 evaluable AML patients', 'A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China', 'de-novo acute myeloid leukemia for adult patients', 'newly diagnosed patients of adult AML', 'adult patients with de-novo acute myeloid leukemia (AML) ']","['idarubicin combined with cytarabine', 'IA regimen which contains idarubicin (IDA) 8 mg/m(2), 10 mg/m(2) or 12 mg/m(2) as induction chemotherapy', 'idarubicin']","['median time (days) of neutrophil count', 'response rate of complete remission (CR) , adverse events', 'blast ratio of bone marrow, FAB classification and risk stratification, the odds ratios', 'efficacy and safety', 'platelet count', 'CR rates', 'beneficial factor affecting CR', 'incidences of lung infection']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}]",1215.0,0.155343,"In the intermediate and favorable groups, CR rates was 76.5% (163/213) , 86.9% (506/582) and 86.1% (68/79) in different doses of IDA ( P =0.007) .","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Sun', 'Affiliation': 'Jiangsu Institute of Hematology, the First Affiliated Hospital of Soochow University, Collaborative Innovation Center of Hematology, Soochow University, Suzhou Institute of Blood and Marrow Transplantation, Suzhou 215006, China.'}, {'ForeName': 'X P', 'Initials': 'XP', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'X S', 'Initials': 'XS', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Q S', 'Initials': 'QS', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Z M', 'Initials': 'ZM', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'K Q', 'Initials': 'KQ', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Liao', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Z P', 'Initials': 'ZP', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Institute of Hematology, the First Affiliated Hospital of Soochow University, Collaborative Innovation Center of Hematology, Soochow University, Suzhou Institute of Blood and Marrow Transplantation, Suzhou 215006, China.'}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2017.12.003']
1264,29299888,Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision.,"PURPOSE


Penile nerve block is the most popular nerve block for the circumcision in pediatric patients. This study aimed to compare the analgesic efficiency of penile nerve block and the pudendal nerve block on postoperative pain and additional analgesic requirements in children undergoing circumcision.
MATERIAL AND METHODS


This prospective randomized double-blind study enrolled 85 children, aged 1 to10 years, undergoing circumcision. The patients were randomly divided into two groups either receiving dorsal penile block group (PNB-Group) or pudendal nerve block (PDB-Group). In the PNB-Group, 0.3 ml/kg 0.25 % bupivacaine was used; and, in the PDB-Group, 0.3 ml/kg bupivacaine was applied with nerve stimulator at a concentration of 0.25%. In the postoperative period, the modified CHEOPS pain scale scoring and additional analgesic demand were evaluated at the 5th and 30th minutes and at the 1st and 2nd hours. The subsequent pain evaluations were made by the parents at home, at the postoperative 6th, 12th, 18th and 24th hours.
RESULTS


Seven patients were excluded from the study, and seventy eight patients were evaluated for analysis. Patients in PDB-Group had significantly lower postoperative pain intensity and lower mCHEOPS scores (3.83 ± 0.98) when compared to the PNB-Group (6.47 ± 0.91) (P < .01) at all measurement times and none of patients in PDB-Group had additional analgesic requirements up to 24 hours. Patients in the PNB-Group had significantly more analgesic requirements at all measurements times except at the 1st, 2nd, 24th hours. 3.8%, 30.8%, 46.2% and 59% of the patients in the PNB group needed additional analgesia respectively at 5th, 6th, 12th and 18th hours.
CONCLUSION


Pudendal nerve block provided additional analgesic free period and had better analgesic efficiency compared to the penile nerve block lasting until 24 hours after operation.",2018,"Patients in the PNB-Group had significantly more analgesic requirements at all measurements times except at the 1st, 2nd, 24th hours.","['children undergoing circumcision', 'Children Undergoing Circumcision', 'pediatric patients', 'enrolled 85 children, aged 1 to10 years, undergoing circumcision', 'Seven patients were excluded from the study, and seventy eight patients were evaluated for analysis']","['penile nerve block and the pudendal nerve block', 'bupivacaine', 'dorsal penile block group (PNB-Group) or pudendal nerve block (PDB-Group', 'Pudendal Nerve Block Versus Penile Nerve Block']","['modified CHEOPS pain scale scoring and additional analgesic demand', 'additional analgesic requirements', 'subsequent pain evaluations', 'postoperative pain intensity and lower mCHEOPS scores', 'analgesic efficiency', 'additional analgesia', 'postoperative pain and additional analgesic requirements', 'analgesic requirements']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0228959', 'cui_str': 'Pudendal Nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0394769', 'cui_str': 'Local anesthetic penile block (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",85.0,0.056487,"Patients in the PNB-Group had significantly more analgesic requirements at all measurements times except at the 1st, 2nd, 24th hours.","[{'ForeName': 'Ayse Cigdem', 'Initials': 'AC', 'LastName': 'Tutuncu', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY. actutuncu@gmail.com.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Kendigelen', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}, {'ForeName': 'Gulruh', 'Initials': 'G', 'LastName': 'Ashyyeralyeva', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}, {'ForeName': 'Fatis', 'Initials': 'F', 'LastName': 'Altintas', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}, {'ForeName': 'Senol', 'Initials': 'S', 'LastName': 'Emre', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Pediatric Surgery, Istanbul TURKEY.'}, {'ForeName': 'Rahsan', 'Initials': 'R', 'LastName': 'Ozcan', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Pediatric Surgery, Istanbul TURKEY.'}, {'ForeName': 'Guner', 'Initials': 'G', 'LastName': 'Kaya', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}]",Urology journal,['10.22037/uj.v0i0.4292']
1265,29294732,Individual Versus Group Cognitive-Behavioral Therapy for Partner-Violent Men: A Preliminary Randomized Trial.,"A randomized clinical trial tested the hypothesis that a flexible, case formulation-based, individual treatment approach integrating motivational interviewing strategies with cognitive-behavioral therapy (ICBT) is more efficacious than a standardized group cognitive-behavioral approach (GCBT) for perpetrators of intimate partner violence (IPV). Forty-two men presenting for services at a community domestic violence agency were randomized to receive 20 sessions of ICBT or a 20-week group cognitive-behavioral therapy (CBT) program. Participants and their relationship partners completed assessments of relationship abuse and relationship functioning at baseline and quarterly follow-ups for 1 year. Treatment uptake and session attendance were significantly higher in ICBT than GCBT. However, contrary to the study hypothesis, GCBT produced consistently equivalent or greater benefits than ICBT. Participant self-reports revealed significant reductions in abusive behavior and injuries across conditions with no differential benefits between conditions. Victim partner reports revealed more favorable outcomes for group treatment, including a statistically significant difference in psychological aggression, and differences exceeding a medium effect size for physical assault, emotional abuse, and partner relationship adjustment. In response to hypothetical relationship scenarios, GCBT was associated with greater reductions than ICBT (exceeding a medium effect) in articulated cognitive distortions and aggressive intentions. Treatment competence ratings suggest that flexible, individualized administration of CBT creates challenges in session agenda setting, homework implementation, and formal aspects of relationship skills training. Although caution is needed in generalizing findings from this small-scale trial, the results suggest that the mutual support and positive social influence available in group intervention may be particularly helpful for IPV perpetrators.",2020,"In response to hypothetical relationship scenarios, GCBT was associated with greater reductions than ICBT (exceeding a medium effect) in articulated cognitive distortions and aggressive intentions.","['Partner-Violent Men', 'Forty-two men presenting for services at a community domestic violence agency']","['GCBT', 'ICBT or a 20-week group cognitive-behavioral therapy (CBT) program', 'cognitive-behavioral therapy (ICBT', 'Individual Versus Group Cognitive-Behavioral Therapy', 'ICBT']","['psychological aggression, and differences exceeding a medium effect size for physical assault, emotional abuse, and partner relationship adjustment', 'Treatment uptake and session attendance']","[{'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0206073', 'cui_str': 'Domestic Violence'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0740319', 'cui_str': 'Physical assault'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse (event)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",42.0,0.0241597,"In response to hypothetical relationship scenarios, GCBT was associated with greater reductions than ICBT (exceeding a medium effect) in articulated cognitive distortions and aggressive intentions.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': 'University of Maryland, Baltimore County, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Eckhardt', 'Affiliation': 'Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Clifford', 'Affiliation': 'University of Maryland, Baltimore County, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'LaMotte', 'Affiliation': 'University of Maryland, Baltimore County, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Meis', 'Affiliation': 'Minneapolis VA Health Care System, MN, USA.'}]",Journal of interpersonal violence,['10.1177/0886260517705666']
1266,31630089,Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT).,"BACKGROUND


One-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP.
METHODS


206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6-8 weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models.
RESULTS


CFT reduced disability more than the group intervention at 6 months (mean difference, 8.65; 95% CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95% CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056) or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134).
CONCLUSION


CFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry (NCT02145728).",2020,An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT).,"['206 adults with CLBP', 'chronic low back pain']","['Cognitive functional therapy compared with a group-based exercise and education intervention', 'CFT', 'physiotherapist-delivered individualised intervention (CFT', 'physiotherapist-delivered group-based exercise and education', 'individualised intervention called cognitive functional therapy (CFT', 'CFT (n=106) or group-based exercise and education']","['pain intensity', 'disability and pain intensity', 'disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",206.0,0.198245,An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT).,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'Institute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia mary.okeeffe@sydney.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Shenton Park, Perth, Western Australia, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Purtill', 'Affiliation': 'Department of Mathematics & Statistics, Faculty of Science & Engineering, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Bargary', 'Affiliation': 'Department of Mathematics & Statistics, Faculty of Science & Engineering, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}]",British journal of sports medicine,['10.1136/bjsports-2019-100780']
1267,31629118,Feasibility and Effectiveness of Telelactation Among Rural Breastfeeding Women.,"OBJECTIVE


To evaluate the feasibility and impact of telelactation via personal electronic devices on breastfeeding duration and exclusivity among rural women.
METHODS


The Tele-MILC trial, a pragmatic, parallel design trial, recruited 203 women during their postpartum hospitalization in a critical access hospital in Pennsylvania and randomized them to receive telelactation (n = 102) or usual care (n = 101). We used intent-to-treat (ITT) and instrumental variable (IV) approaches to analyze study data for the 187 participants who completed follow-up. The primary outcomes were any breastfeeding and exclusive breastfeeding at 12 weeks postpartum.
RESULTS


Among participants in the telelactation arm, 50% (47/94) reported participating in video calls. At 12 weeks, 71% of participants in the telelactation arm versus 68% of control participants were breastfeeding in the ITT model (3% difference, P = .73), whereas 73% of participants in the telelactation arm versus 68% of control participants were breastfeeding in the IV model (5% difference, P = .74). Among participants who were still breastfeeding at 12 weeks, 51% participants in the telelactation arm were breastfeeding exclusively versus 46% of control participants in the ITT model (5% difference, P = .47), whereas 56% of participants in the telelactation arm were breastfeeding exclusively versus 45% of control participants in the IV model (11% difference, P = .48). In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant.
CONCLUSIONS


This trial demonstrated that telelactation can be implemented with a rural underserved population. Though this trial was not powered to detect differences in breastfeeding duration and exclusivity, and none were observed, telelactation remains a promising approach for further investigation. ClinicalTrials.gov Identifier: NCT02870413.",2020,"In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant.
","['rural underserved population', '203 women during their postpartum hospitalization in a critical access hospital in Pennsylvania and randomized them to receive telelactation (n=102) or usual care (n=101', 'participants in the telelactation arm, 50% (47/94) reported participating in video calls', 'rural women', 'Rural Breastfeeding Women', '187 participants who completed follow-up']","['Telelactation', 'telelactation via personal electronic devices']","['breastfeeding and exclusive breastfeeding at 12 weeks postpartum', 'breastfeeding duration and exclusivity', 'breastfeeding in the ITT model']","[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",203.0,0.165296,"In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant.
","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Uscher-Pines', 'Affiliation': 'RAND Corporation (L Uscher-Pines, B Ghosh-Dastidar, and KA Kapinos), Arlington, Va. Electronic address: luscherp@rand.org.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ghosh-Dastidar', 'Affiliation': 'RAND Corporation (L Uscher-Pines, B Ghosh-Dastidar, and KA Kapinos), Arlington, Va.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine (DL Bogen and KN Ray), Pittsburgh, Pa.'}, {'ForeName': 'Kristin N', 'Initials': 'KN', 'LastName': 'Ray', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine (DL Bogen and KN Ray), Pittsburgh, Pa.'}, {'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Demirci', 'Affiliation': 'University of Pittsburgh School of Nursing (JR Demirci), Pittsburgh, Pa.'}, {'ForeName': 'Ateev', 'Initials': 'A', 'LastName': 'Mehrotra', 'Affiliation': 'Harvard Medical School (A Mehrotra), Boston, Mass.'}, {'ForeName': 'Kandice A', 'Initials': 'KA', 'LastName': 'Kapinos', 'Affiliation': 'RAND Corporation (L Uscher-Pines, B Ghosh-Dastidar, and KA Kapinos), Arlington, Va.'}]",Academic pediatrics,['10.1016/j.acap.2019.10.008']
1268,31585725,"Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report.","BACKGROUND


Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children. Age restrictions and other limitations of existing oral live-attenuated typhoid and parenteral Vi polysaccharide vaccines have triggered the development of Vi conjugate vaccines with improved immunological properties, use in younger age range, and longer durability of protection. We present the safety, reactogenicity, and immunogenicity data from a Phase II study after a single dose of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) conducted in 6-23-month old Filipino children.
METHODS


This is a randomized, observer-blinded Phase II study to assess the immunogenicity, safety and reactogenicity of Vi-DT compared to placebo, conducted in Muntinlupa City, The Philippines. Participants aged 6-23 months were enrolled and randomized to Vi-DT (25 µg) or placebo (0.9% sodium chloride) and evaluated for immunogenicity and overall safety 28 days post vaccination.
RESULTS


A total of 285 participants were enrolled and age-stratified: 6 to < 9 months, 9-12 months, and 13-23 months. Seventy-six (76) participants received Vi-DT and 19 received placebo per each strata. All participants seroconverted after a single dose of Vi-DT versus 7% of placebo recipients. Anti-Vi IgG GMT was 444.38 [95% CI (400.28; 493.34)] after a single dose of Vi-DT; there was no change in GMT after placebo administration, 0.41 [95% CI (0.33; 0.51), p < 0.0001]. A similar pattern of immunogenicity was reported across all age strata. The vaccine reported to be safe and well tolerated.
CONCLUSIONS


Vi-DT vaccine was immunogenic, safe, and well tolerated in children aged 6-23 months. ClinicalTrials.gov registration number: NCT03527355.",2020,"BACKGROUND


Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","['Muntinlupa City, The Philippines', 'healthy Filipino infants and toddlers', 'school-aged children', 'Participants aged 6-23\u202fmonths', '6-23-month old Filipino children', '285 participants were enrolled and age-stratified: 6 to < 9\u202fmonths, 9-12\u202fmonths, and 13-23\u202fmonths', 'Seventy-six (76) participants received', 'children aged 6-23\u202fmonths']","['Vi-DT vaccine', 'Vi-DT', 'placebo (0.9% sodium chloride', 'placebo', 'Vi-DT typhoid conjugate vaccine', 'Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT']","['safety, reactogenicity, and immunogenicity data', 'GMT', 'Immunogenicity, safety and reactogenicity', 'safe and well tolerated', 'immunogenicity, safety and reactogenicity']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1556093', 'cui_str': 'Filipinos (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0058773', 'cui_str': 'DT Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",285.0,0.64885,"BACKGROUND


Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Alberto', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Saluja', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea. Electronic address: tarun.saluja@ivi.int.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Teshome', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ju Yeon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Chinaworapong', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwook', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sue-Kyoung', 'Initials': 'SK', 'LastName': 'Jo', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Seon-Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Ham', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Hwa', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'T Anh', 'Initials': 'TA', 'LastName': 'Wartel', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}]",Vaccine,['10.1016/j.vaccine.2019.09.074']
1269,29398771,Lessons from in-home air filtration intervention trials to reduce urban ultrafine particle number concentrations.,"Background


Exposure to airborne ultrafine particle (UFP; <100 nm in aerodynamic diameter) is an emerging public health problem. Nevertheless, the benefit of using high efficiency particulate arrestance (HEPA) filtration to reduce UFP concentrations in homes is not yet clear.
Methods


We conducted a randomized crossover study of HEPA filtration without a washout period in 23 homes of low-income Puerto Ricans in Boston and Chelsea, MA (USA). Most participants were female, older adults who were overweight or obese. Particle number concentrations (PNC, a proxy for UFP) were measured indoors and outdoors at each home continuously for six weeks. Homes received both HEPA filtration and sham filtration for three weeks each in random order.
Results


Median PNC under HEPA filtration was 50-85% lower compared to sham filtration in most homes, but we found no benefit in terms of reduced inflammation; associations between hsCRP, IL-6, or TNFRII in blood samples and indoor PNC were inverse and not statistically significant.
Conclusions


Limitations to our study design likely contributed to our findings. Limitations included carry-over effects, a population that may have been relatively unresponsive to UFP, reduction in PNC even during sham filtration that limited differences between HEPA and sham filtration, window opening by participants, and lack of fine-grained (room-specific) participant time-activity information. Our approach was similar to other recent HEPA intervention studies of particulate matter exposure and cardiovascular risk, suggesting that there is a need for better study designs.",2017,"Particle number concentrations (PNC, a proxy for UFP) were measured indoors and outdoors at each home continuously for six weeks.","['Most participants were female, older adults who were overweight or obese', '23 homes of low-income Puerto Ricans in Boston and Chelsea, MA (USA']","['airborne ultrafine particle (UFP; <100 nm in aerodynamic diameter', 'HEPA filtration and sham filtration', 'HEPA filtration']","['reduced inflammation; associations between hsCRP, IL-6, or TNFRII in blood samples and indoor PNC', 'UFP concentrations', 'Median PNC under HEPA filtration', 'Particle number concentrations (PNC, a proxy for UFP']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0006037', 'cui_str': 'Boston'}]","[{'cui': 'C0077801', 'cui_str': 'Ultrafine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C1264651', 'cui_str': 'Number concentration'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}]",,0.212601,"Particle number concentrations (PNC, a proxy for UFP) were measured indoors and outdoors at each home continuously for six weeks.","[{'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Brugge', 'Affiliation': 'Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave., Boston, MA 02111.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Simon', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University School of Engineering, Tufts University, Medford, MA 02155.'}, {'ForeName': 'Neelakshi', 'Initials': 'N', 'LastName': 'Hudda', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University School of Engineering, Tufts University, Medford, MA 02155.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Zellmer', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University School of Engineering, Tufts University, Medford, MA 02155.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Corlin', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University School of Engineering, Tufts University, Medford, MA 02155.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cleland', 'Affiliation': 'Department of Community Health, Tufts University, Medford, MA 02155.'}, {'ForeName': 'Eda Yiqi', 'Initials': 'EY', 'LastName': 'Lu', 'Affiliation': 'University of Massachusetts Amherst, 360 Campus Center Way, Amherst, MA 01003.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Rivera', 'Affiliation': 'Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave., Boston, MA 02111.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Department of Community Health, Tufts University, Medford, MA 02155.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Chung', 'Affiliation': 'Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave., Boston, MA 02111.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Durant', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University School of Engineering, Tufts University, Medford, MA 02155.'}]",Building and environment,['10.1016/j.buildenv.2017.10.007']
1270,31625399,Psychosocial impact of inclusion of HPV test on the management of women with atypical squamous cells of undetermined significance: a study within a randomised pragmatic trial in a middle-income country.,"Objective:  To assess the psychosocial impact of human papillomavirus (HPV) testing, colposcopy, and Pap-smear, as triage strategies after a Pap-smear with atypical squamous cells of undetermined significance (ASCUS). We also sought to evaluate the psychosocial impact based on the results of the strategies.  Methods:  Nested within a randomised pragmatic trial, which compared an immediate colposcopy, repeat Pap-smear, and high risk HPV test, we enrolled 675 women between 2012 and 2014. Participants completed surveys at enrollment, two weeks after triage test results, and 1 year thereafter to assess cervical cancer and HPV knowledge, self-esteem, anxiety and HPV impact (HIP).  Results:  Knowledge, self-esteem, anxiety and HIP improved with no differences among arms. At the baseline, 31.4% and 32.7% of the participants had state anxiety and trait anxiety, respectively, which decreased to 10.7% and 13.3% in the last survey. Compared to HPV-negative women, HPV-positive women in the second survey had worse HIP scores (HPV-:  M  22.9 [SD: 15.20]; HPV+:  M  35.9 [SD: 19.91];  p <  0.001), trait anxiety (HPV-:  M  15.4 [SD 12.73]; HPV+:  M  22.9 [SD 13.29];  p  = 0.001), and state anxiety (HPV-:  M  10.7 [SD 11.25]; HPV+:  M  21.4 [SD 14.81];  p <  0.001).  Conclusions : HPV testing as a triage strategy for women with ASCUS does not differ from colposcopies or Pap-smears in terms of psychosocial outcomes.",2020,"Results:  Knowledge, self-esteem, anxiety and HIP improved with no differences among arms.","['women with atypical squamous cells of undetermined significance', 'women with ASCUS', 'enrolled 675 women between 2012 and 2014']","['HPV test', 'human papillomavirus (HPV) testing, colposcopy, and Pap-smear', 'HPV', 'immediate colposcopy, repeat Pap-smear, and high risk HPV test']","['Results:  Knowledge, self-esteem, anxiety and HIP', 'state anxiety and trait anxiety', 'state anxiety', 'trait anxiety', 'HIP scores', 'cervical cancer and HPV knowledge, self-esteem, anxiety and HPV impact (HIP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0521184', 'cui_str': 'ASCUS'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0079104', 'cui_str': 'Cervical Smears'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",675.0,0.123197,"Results:  Knowledge, self-esteem, anxiety and HIP improved with no differences among arms.","[{'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Garcés-Palacio', 'Affiliation': 'Grupo de Epidemiología, Facultad Nacional de Salud Pública, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Gloria I', 'Initials': 'GI', 'LastName': 'Sanchez', 'Affiliation': 'Grupo Infección y Cáncer, Facultad de Medicina, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Baena Zapata', 'Affiliation': 'Grupo Infección y Cáncer, Facultad de Medicina, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Córdoba Sánchez', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Yenny', 'Initials': 'Y', 'LastName': 'Urrea Cosme', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez Zabala', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Ruiz Osorio', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia (UdeA), Medellín, Colombia.'}]",Psychology & health,['10.1080/08870446.2019.1678749']
1271,29369240,CapsoCam SV-1 Versus PillCam SB 3 in the Detection of Obscure Gastrointestinal Bleeding: Results of a Prospective Randomized Comparative Multicenter Study.,"BACKGROUND AND STUDY AIM


Newer capsule with a panoramic viewing mode is available and might increase the detection rate of bleeding lesions in patients with obscure gastrointestinal bleeding (OGIB). Furthermore, an improved patient acceptance rate is expected.
MATERIALS AND METHODS


In a randomized prospective comparative multicenter study, patients with OGIB were included and examined either with CapsoCam SV-1 or with PillCam SB 3. Detection of bleeding lesions, transit, and evaluation time and adverse events were evaluated. Physicians were interviewed about their experience with both capsules and the evaluation software. A detailed subject questionnaire analyzed acceptance of each capsule. Follow-up was 3 months.
RESULTS


In total, 181 patients with OGIB were recruited into the study. After exclusion of 28 patients 153 patients were randomized and CapsoCam SV-1 (n=78) or PillCam SB 3 (n=75) was administered. CapsoCam SV-1 detected more cases of bleeding (31/79, diagnostic yield 39.7%) compared with PillCam SB 3 (26/75, diagnostic yield 34.6%, NS). Transit time of both capsules was not different. Evaluation time with PillCam SB 3 was superior to CapsoCam SV-1 (27 vs. 40 min, P=0.01). In total, 95% of the physicians were satisfied with each capsule system and evaluation software. The acceptance rate of the patients to retrieve the CapsoCam SV-1 was high. Adverse events/serious adverse events were 17.9%/1.3% with CapsoCam SV-1 and 16%/0% with PillCam SB 3. Rebleeding rate was 28.75% within 3 months.
CONCLUSIONS


CapsoCam SV-1 detected more lesions; however, relevant bleeding sources were visualized by both capsules. Physician's satisfaction was high with both capsule systems and evaluation software. Patient's acceptance with CapsoCam SV-1 was unexpectedly high. Serious adverse events were 0% with PillCam SB 3 and 1.3% with CapsoCam SV-1.",2019,"CapsoCam SV-1 detected more cases of bleeding (31/79, diagnostic yield 39.7%) compared with PillCam SB 3 (26/75, diagnostic yield 34.6%, NS).","['181 patients with OGIB were recruited into the study', 'patients with obscure gastrointestinal bleeding (OGIB', '28 patients 153 patients', 'patients with OGIB', 'Obscure Gastrointestinal Bleeding']","['CapsoCam SV-1 or with PillCam SB 3', 'PillCam SB', 'CapsoCam SV-1']","['acceptance rate', 'bleeding', 'Rebleeding rate', ""Physician's satisfaction"", 'Transit time', 'Adverse events/serious adverse events', 'Detection of bleeding lesions, transit, and evaluation time and adverse events', 'detection rate of bleeding lesions', 'patient acceptance rate', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4302233', 'cui_str': 'Obscure gastrointestinal bleeding'}]",[],"[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",181.0,0.034936,"CapsoCam SV-1 detected more cases of bleeding (31/79, diagnostic yield 39.7%) compared with PillCam SB 3 (26/75, diagnostic yield 34.6%, NS).","[{'ForeName': 'Lilli L', 'Initials': 'LL', 'LastName': 'Zwinger', 'Affiliation': 'Campus Benjamin Franklin, Medical Department of Gastroenterology, Infectious Diseases and Rheumatology.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Siegmund', 'Affiliation': 'Campus Benjamin Franklin, Medical Department of Gastroenterology, Infectious Diseases and Rheumatology.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Stroux', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Adler', 'Affiliation': 'Campus Virchow Klinikum.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Veltzke-Schlieker', 'Affiliation': 'Campus Virchow Klinikum.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wentrup', 'Affiliation': 'Campus Mitte, Medical Department of Gastroenterology and Hepatology, Charité University Medicine.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jürgensen', 'Affiliation': 'Campus Mitte, Medical Department of Gastroenterology and Hepatology, Charité University Medicine.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Wiedenmann', 'Affiliation': 'Campus Virchow Klinikum.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Wiedbrauck', 'Affiliation': 'General Hospital Celle, Medical Department of Gastroenterology, Celle, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Hollerbach', 'Affiliation': 'General Hospital Celle, Medical Department of Gastroenterology, Celle, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Liceni', 'Affiliation': 'Ambulatory Healthcare Center, Bayerischer Platz, Berlin.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bojarski', 'Affiliation': 'Campus Benjamin Franklin, Medical Department of Gastroenterology, Infectious Diseases and Rheumatology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000000994']
1272,29308579,Improvement of Erection Related Incision Pain in Circumcision Patients using Interrupted Rapid Eye Movement Sleep: A Randomized Controlled Study.,"INTRODUCTION


Postoperative pain from male circumcision (MC) is common especially in the sleep-related erection period. This study aims to explore the effect of interrupted rapid eye movement (IREM) sleep on relieving SRE-related incision pain and the improvement of other clinical outcomes.
MATERIALS AND METHODS


This simple randomized controlled study was conducted between May and November 2016. Approval was obtained from the local ethical committee on 5 May 2016. Ninety participants who underwent male circumcision were divided into the interrupted rapid eye movement sleep group and the control group. The times and the cumulative time of erection-related moderate and severe pain in minutes at night for 3 days after the operation were observed and compared. We also compared the condition of the incision swelling and healing.Sleep time at night was used to evaluate the safety of interrupted rapid eye movement sleep.
RESULTS


For the first 3 days after the operation, the times of sleep-related erection pain were significantly decreased in the IREM sleep group (P = .010). Five patients reported that there was no pain during night. The cumulative time of erection-related moderate and severe pain was statistically decreased in the interrupted rapid eye movement sleep group (P = .034). After 3 days, there was no moderate and severe pain related to sleep-related erection in the 2 groups. There were no significant differences in incision swelling (P = .768), healing (P = .626), and sleep time (P = .231).
CONCLUSION


Interrupted rapid eye movement sleep is an effective, simple, and free treatment to relieve incision pain of sleep-related erections.",2018,"There were no significant differences in incision swelling (P = .768), healing (P = .626), and sleep time (P = .231).
","['Circumcision Patients using Interrupted Rapid Eye Movement Sleep', 'Ninety participants who underwent male circumcision']","['interrupted rapid eye movement (IREM) sleep', 'Interrupted rapid eye movement sleep', 'interrupted rapid eye movement sleep group and the control group']","['incision swelling', 'times of sleep-related erection pain', 'moderate and severe pain', 'cumulative time of erection-related moderate and severe pain', 'Sleep time', 'sleep time', 'Erection Related Incision Pain', 'healing', 'incision swelling and healing']","[{'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}]","[{'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",90.0,0.0609254,"There were no significant differences in incision swelling (P = .768), healing (P = .626), and sleep time (P = .231).
","[{'ForeName': 'A-Juan', 'Initials': 'AJ', 'LastName': 'Dai', 'Affiliation': 'Division of anesthesia surgery, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China. dai_ajuan@163.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Soochow University, No.1 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Soochow University, No.1 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China.'}]",Urology journal,['10.22037/uj.v0i0.3981']
1273,31629944,Cluster Randomized Trial of a Pre/Interconception Health Intervention for Mothers in Pediatric Visits.,"OBJECTIVE


Recognizing that pediatric primary care focuses on family health and is an important location of contact for women of childbearing age, this project assessed the effectiveness of a pre/interconception women's health intervention delivered during pediatric primary care using a cluster randomized trial.
METHODS


Pediatric clinicians were randomized to a screening and brief educational intervention group or usual care comparison group. Intervention group clinicians received training on pre/interconception care, including recommended counseling and referral resources for needs identified. Women presenting to primary care with their child ≤12 months were enrolled and assigned to the group corresponding to the assignment of their child's clinician. Mothers seen by clinicians in the intervention group completed a pre/interconception health screening tool and discussed results with their child's clinician during the visit. These mothers were compared to mothers seen by comparison group clinicians who did not receive the screening tool or clinician discussion. All enrolled mothers (Intervention and Comparison) received written preconception health information and a 90-day supply of multivitamins. Primary outcomes at 6 and 12 months post enrollment included contraception use, pregnancy, and access to and use of preventive health care. Secondary outcomes included daily folic acid supplementation, smoking, and substance use.
RESULTS


A total of 415 women were enrolled and those who had at least 1 follow-up assessment were included in the analysis (n = 383). There was no significant effect of the intervention on contraceptive use, pregnancy incidence, or use of preventive care. Assignment to the intervention increased the odds of daily folic acid use (odds ratio 1.82, 95% confidence interval 1.25, 2.63) during follow-up. Intervention mothers were less likely to smoke at 6, but not 12 months.
CONCLUSIONS


Pediatric visits are an opportune location for addressing maternal health and this intervention demonstrated feasibility and improved outcomes for some but not all outcomes. Attention to maternal health needs in pediatric visits during infancy may be important for maintaining positive pre/interconception health behaviors.",2020,"Assignment to the intervention increased the odds of daily folic acid use [OR 1.82, 95% CI 1.25, 2.63] during follow-up.","['Mothers In Pediatric Visits', 'women of childbearing age', 'Pediatric clinicians', '415 women were enrolled and those who had at least one follow-up assessment were included in the analysis (n= 383', 'Women presenting to primary care with their child ≤12 months']","['written preconception health information and a 90 day supply of multivitamins', 'screening and brief educational intervention group or usual care comparison group', 'training on pre/interconception care, including recommended counseling and referral resources for needs identified', 'Pre/Interconception Health Intervention']","['daily folic acid supplementation, smoking and substance use', 'contraception use, pregnancy, and access to and use of preventive health care', 'contraceptive use, pregnancy incidence, or use of preventive care', 'odds of daily folic acid use']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0033109', 'cui_str': 'Preventive Health'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4277527', 'cui_str': 'Preventive Care'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]",415.0,0.0515678,"Assignment to the intervention increased the odds of daily folic acid use [OR 1.82, 95% CI 1.25, 2.63] during follow-up.","[{'ForeName': 'Krishna K', 'Initials': 'KK', 'LastName': 'Upadhya', 'Affiliation': ""Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Division of Adolescent and Young Adult Medicine, Children's National Medical Center, (KK Upadhya), Washington, DC.""}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Psoter', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Connor', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md.'}, {'ForeName': 'Kamila B', 'Initials': 'KB', 'LastName': 'Mistry', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Office of Extramural Research, Education and Priority Populations, Agency for Healthcare Research and Quality, (KB Mistry), Rockville, Md.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Levy', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Child and Teen Wellness Center, (DJ Levy), Owings Mills, Md.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, (TL Cheng), Baltimore, Md. Electronic address: tcheng2@jhmi.edu.'}]",Academic pediatrics,['10.1016/j.acap.2019.10.003']
1274,29455404,The Effect of Pre-Surgery Information Online Lecture on Nutrition Knowledge and Anxiety Among Bariatric Surgery Candidates.,"INTRODUCTION


Best practices for patient education in bariatric surgery (BS) remain undefined. The aims of this study were to evaluate the effect of an online lecture on nutrition knowledge, weight loss expectations, and anxiety among BS candidates and present a new tool to assess this knowledge before BS.
METHODS


An interventional non-randomized controlled trial on 200 BS candidates recruited while attending a pre-BS committee. The first 100 consecutive patients were assigned to the control group and the latter 100 consecutive patients to the intervention group and were instructed to watch an online lecture of 15-min 1-2 weeks prior to surgery. All participants completed a BS nutrition knowledge and the state-trait anxiety inventory (STAI) questionnaires at the pre-BS committee and once again at the pre-surgery clinic. Body mass index (BMI), comorbidities, surgery type, marital status, and number of dietitian sessions were obtained from medical records.
RESULTS


Data for paired study questionnaires scores were available for 128 patients (n = 69 and n = 59 for the control and intervention groups, respectively), with a mean age and BMI of 40.3 ± 11.4 years and 41.3 ± 4.9 kg/m 2 , respectively. The BS nutrition knowledge and the state anxiety scores increased for both study groups at the pre-surgery clinic as compared to the pre-BS committee (P ≤ 0.028), but the improvement in the nutrition knowledge score was significantly higher for the intervention group (P = 0.030). No within or between-group differences were found for the trait anxiety items score. The ""dream"" and ""realistic"" weight goals were lower than the expected weight loss according to 70% excess weight loss (EWL) for both study groups at both time-points (P < 0.001 for all).
CONCLUSION


Education by an online lecture prior to the surgery improves BS nutrition knowledge, but not anxiety. ClinicalTrials.gov number: NCT02857647.",2018,"The BS nutrition knowledge and the state anxiety scores increased for both study groups at the pre-surgery clinic as compared to the pre-BS committee (P ≤ 0.028), but the improvement in the nutrition knowledge score was significantly higher for the intervention group (P = 0.030).","['200 BS candidates recruited while attending a pre-BS committee', '128 patients (n\u2009=\u200969 and n\u2009=\u200959 for the control and intervention groups, respectively), with a mean age and BMI of 40.3\u2009±\u200911.4\xa0years and 41.3\u2009±\u20094.9\xa0kg/m 2 , respectively', '100 consecutive patients were assigned to the control group and the latter 100 consecutive patients to the']","['online lecture', 'Pre-Surgery Information Online Lecture', 'intervention group and were instructed to watch an online lecture of 15-min 1-2\xa0weeks prior to surgery']","['BS nutrition knowledge and the state-trait anxiety inventory (STAI) questionnaires', 'BS nutrition knowledge', 'trait anxiety items score', 'Body mass index (BMI), comorbidities, surgery type, marital status, and number of dietitian sessions', 'nutrition knowledge score', 'Nutrition Knowledge and Anxiety', 'BS nutrition knowledge and the state anxiety scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",200.0,0.0712859,"The BS nutrition knowledge and the state anxiety scores increased for both study groups at the pre-surgery clinic as compared to the pre-BS committee (P ≤ 0.028), but the improvement in the nutrition knowledge score was significantly higher for the intervention group (P = 0.030).","[{'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Sherf-Dagan', 'Affiliation': 'Department of Nutrition, Assuta Medical Center, Tel-Aviv, Israel. shirisherf@gmail.com.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Hod', 'Affiliation': 'Research division, Epidemiological service, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Limor', 'Initials': 'L', 'LastName': 'Mardy-Tilbor', 'Affiliation': 'Department of Nutrition, Assuta Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Shir', 'Initials': 'S', 'LastName': 'Gliksman', 'Affiliation': 'Department of Nutrition, Assuta Medical Center, Rishon LeZion, Israel.'}, {'ForeName': 'Tair', 'Initials': 'T', 'LastName': 'Ben-Porat', 'Affiliation': 'Department of Nutrition, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Sakran', 'Affiliation': 'Assia Medical Group, Assuta Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Zelber-Sagi', 'Affiliation': 'School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goitein', 'Affiliation': 'Assia Medical Group, Assuta Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Asnat', 'Initials': 'A', 'LastName': 'Raziel', 'Affiliation': 'Assia Medical Group, Assuta Medical Center, Tel-Aviv, Israel.'}]",Obesity surgery,['10.1007/s11695-018-3134-y']
1275,29395526,"Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial.","BACKGROUND


We conducted a randomized, non-inferiority, clinical study of MMR vaccine by a disposable-syringe jet injector (DSJI) in toddlers in India in comparison with the conventional administration.
METHODS


MMR vaccine was administered subcutaneously by DSJI or needle-syringe (N-S) to toddlers (15-18 months) who had received a measles vaccine at 9 months. Seropositivity to measles, mumps, and rubella serum IgG antibodies was assessed 35 days after vaccination. Non-inferiority was concluded if the upper limit of the 95% CI for the difference in the percent of seropositive between groups was less than 10%. Solicited reactions were collected for 14 days after vaccination by using structured diaries.
RESULTS


In each study group, 170 subjects received MMR vaccine. On day 35, seropositivity for measles was 97.5% [95% CI (93.8%, 99.3%)] in the DSJI group and 98.7% [95% CI (95.5%, 99.8%)] in the N-S group; for mumps, 98.8% [95% CI (95.6%, 99.8%)] and 98.7% [95% CI (95.5%, 99.8%)]; and for rubella, 98.8% [95% CI (95.6%, 99.8%)] and 100% [95% CI (97.7%, 100.0%)]; none of the differences were significant. The day 35 post-vaccination GMTs in DSJI and N-S groups were measles: 5.48 IU/ml [95% CI (3.71, 8.11)] and 5.94 IU/ml [95% CI (3.92, 9.01)], mumps: 3.83 ISR [95% CI (3.53, 4.14)] and 3.66 ISR [95% CI (3.39, 3.95)] and rubella: 95.27 IU/ml [95% CI (70.39, 128.95)] and 107.06 IU/ml [95% CI (79.02, 145.06)]; none of the differences were significant. The DSJI group reported 173 solicited local reactions and the N-S group reported 112; most were mild grade. Of the total of 156 solicited systemic adverse events, most were mild, and incidence between the two groups was similar.
CONCLUSIONS


MMR vaccination via DSJI is as immunogenic as vaccination by N-S. Safety profile of DSJI method is similar to N-S except for injection site reactions which are more with DSJI and are well-tolerated. Registration US National Institutes of Health clinical trials identifier - NCT02253407. Clinical trial registry of India identifier - CTRI/2013/05/003702.",2018,"On day 35, seropositivity for measles was 97.5% [95% CI (93.8%, 99.3%)] in the DSJI group and 98.7% [95% CI (95.5%, 99.8%)] in the N-S group; for mumps, 98.8% [95% CI (95.6%, 99.8%)] and 98.7% [95% CI (95.5%, 99.8%)]; and for rubella, 98.8% [95% CI (95.6%, 99.8%)] and 100% [95% CI (97.7%, 100.0%)]; none of the differences were significant.","['India', '170 subjects received', 'toddlers in India in comparison with the conventional administration']","['IU/ml', 'MMR vaccine', 'disposable-syringe jet injector (DSJI', 'DSJI or needle-syringe', 'measles-mumps-rubella vaccine delivered by disposable-syringe jet injector']","['Immunogenicity and safety', 'Seropositivity to measles, mumps, and rubella serum IgG antibodies']","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C0065828', 'cui_str': 'MMR Vaccine'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C3888433', 'cui_str': 'Jet Injector'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.586908,"On day 35, seropositivity for measles was 97.5% [95% CI (93.8%, 99.3%)] in the DSJI group and 98.7% [95% CI (95.5%, 99.8%)] in the N-S group; for mumps, 98.8% [95% CI (95.6%, 99.8%)] and 98.7% [95% CI (95.5%, 99.8%)]; and for rubella, 98.8% [95% CI (95.6%, 99.8%)] and 100% [95% CI (97.7%, 100.0%)]; none of the differences were significant.","[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bavdekar', 'Affiliation': 'KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Oswal', 'Affiliation': 'Bharti Vidyapeeth Deemed University Medical College, Pune, India.'}, {'ForeName': 'Padmasani Venkat', 'Initials': 'PV', 'LastName': 'Ramanan', 'Affiliation': 'Sri Ramachandra Medical Centre, Chennai, India.'}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Aundhkar', 'Affiliation': 'Krishna Institute of Medical Sciences, Karad, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Venugopal', 'Affiliation': 'Andhra Medical College and King George Hospital, Visakhapatnam, India.'}, {'ForeName': 'Dhananjay', 'Initials': 'D', 'LastName': 'Kapse', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'PharmaJet, Golden, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McGray', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Zehrung', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Kulkarni', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India. Electronic address: drpsk@seruminstitute.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2018.01.006']
1276,29497960,Systemic Inflammation in Severe Obese Patients Undergoing Surgery for Obesity and Weight-Related Diseases.,"BACKGROUND


Obesity is a worldwide disease related to genetic, environmental, and behavioral factors, and it is associated with high rates of morbidity and mortality. Recently, obesity has been characterized by a low-grade inflammatory state known as inflammome indicated by chronic increases in circulating concentrations of inflammatory markers. The purpose of this study was to evaluate the effect of weight loss induced by surgery for obesity and weight-related diseases on pro-inflammatory cytokine (TNF-α) and anti-inflammatory adipokine (adiponectin) levels, and on an adipose-derived hormone (leptin) in severely obese subjects.
METHODS


This randomized, controlled trial involved 55 severe obese patients (50 women, age 18-63 years, and body mass index of 35.7-63 kg/m 2 ) who underwent bariatric surgery (BS). Patients with a BMI > 65 kg/m 2  and clinical and mental instability, or significant and unrealistic expectations of surgery were excluded. Blood samples were collected during the fasting period to analyze tumor necrosis factor alpha (TNF-α), adiponectin, and leptin levels by enzyme-linked immunosorbent assay.
RESULTS


At baseline, no significant difference was observed in the anthropometric, demographic, clinical characteristics and biochemistry and inflammatory markers between the control group (CG) and bariatric surgery group (BSG). The same finding was also observed when we compared the baseline variables to those at the 6-month follow-up in the CG. However, the same variables in the BSG group were significantly different between baseline and the 6-month follow-up after BS.
CONCLUSIONS


Weight loss induced by surgery for obesity and weight-related diseases reduced the inflammome state in severely obese patients.",2018,"However, the same variables in the BSG group were significantly different between baseline and the 6-month follow-up after BS.
","['55 severe obese patients (50 women, age 18-63\xa0years, and body mass index of 35.7-63\xa0kg/m 2 ) who underwent bariatric surgery (BS', 'severely obese patients', 'severely obese subjects', 'Patients with a BMI ', 'Severe Obese Patients Undergoing Surgery for Obesity and Weight-Related Diseases']",[],"['anthropometric, demographic, clinical characteristics and biochemistry and inflammatory markers', 'tumor necrosis factor alpha (TNF-α), adiponectin, and leptin levels by enzyme-linked immunosorbent assay', 'Systemic Inflammation', 'pro-inflammatory cytokine (TNF-α) and anti-inflammatory adipokine (adiponectin) levels']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}]",55.0,0.102753,"However, the same variables in the BSG group were significantly different between baseline and the 6-month follow-up after BS.
","[{'ForeName': 'Wilson R', 'Initials': 'WR', 'LastName': 'Freitas', 'Affiliation': ""Master's Degree and PhD Post Graduation Program in Research in Surgery, Santa Casa of Sao Paulo Medical School, Sao Paulo, SP, Brazil.""}, {'ForeName': 'Luis Vicente Franco', 'Initials': 'LVF', 'LastName': 'Oliveira', 'Affiliation': 'School of Medicine, University Center of Anapolis (UniEvangélica), Rua Graciano A. de Souza 514, Lote 28, Quadra 07, Setor Bougainville, Anapolis, GO, 75075-580, Brazil. oliveira.lvf@pq.cnpq.br.'}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': ""Master's Degree and PhD Post Graduation Program in Research in Surgery, Santa Casa of Sao Paulo Medical School, Sao Paulo, SP, Brazil.""}, {'ForeName': 'Elias J', 'Initials': 'EJ', 'LastName': 'Ilias', 'Affiliation': ""Master's Degree and PhD Post Graduation Program in Research in Surgery, Santa Casa of Sao Paulo Medical School, Sao Paulo, SP, Brazil.""}, {'ForeName': 'Carina P', 'Initials': 'CP', 'LastName': 'Lottenberg', 'Affiliation': 'School of Health Sciences, Santa Casa de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Anderson S', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': ""Sleep Laboratory, Master's Degree and PhD Programs in Rehabilitation Sciences, Nove de Julho University (UNINOVE), Sao Paulo, SP, Brazil.""}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Urbano', 'Affiliation': ""Sleep Laboratory, Master's Degree and PhD Programs in Rehabilitation Sciences, Nove de Julho University (UNINOVE), Sao Paulo, SP, Brazil.""}, {'ForeName': 'Manoel C', 'Initials': 'MC', 'LastName': 'Oliveira', 'Affiliation': ""Immunology and Pulmonary Exercise Laboratory, Master's Degree and PhD Program in Rehabilitation Sciences, Nove de Julho University (UNINOVE), Sao Paulo, SP, Brazil.""}, {'ForeName': 'Rodolfo P', 'Initials': 'RP', 'LastName': 'Vieira', 'Affiliation': 'Universidade Brasil, Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), Sao Jose dos Campos, SP, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Ribeiro-Alves', 'Affiliation': 'Evandro Chagas Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Vera L S', 'Initials': 'VLS', 'LastName': 'Alves', 'Affiliation': ""Master's Degree and PhD Post Graduation Program in Research in Surgery, Santa Casa of Sao Paulo Medical School, Sao Paulo, SP, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Kassab', 'Affiliation': ""Master's Degree and PhD Post Graduation Program in Research in Surgery, Santa Casa of Sao Paulo Medical School, Sao Paulo, SP, Brazil.""}, {'ForeName': 'Fabio R', 'Initials': 'FR', 'LastName': 'Thuler', 'Affiliation': ""Master's Degree and PhD Post Graduation Program in Research in Surgery, Santa Casa of Sao Paulo Medical School, Sao Paulo, SP, Brazil.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Malheiros', 'Affiliation': ""Master's Degree and PhD Post Graduation Program in Research in Surgery, Santa Casa of Sao Paulo Medical School, Sao Paulo, SP, Brazil.""}]",Obesity surgery,['10.1007/s11695-017-3104-9']
1277,29422384,"Efficacy and safety of primaquine and methylene blue for prevention of Plasmodium falciparum transmission in Mali: a phase 2, single-blind, randomised controlled trial.","BACKGROUND


Primaquine and methylene blue are gametocytocidal compounds that could prevent Plasmodium falciparum transmission to mosquitoes. We aimed to assess the efficacy and safety of primaquine and methylene blue in preventing human to mosquito transmission of P falciparum among glucose-6-phosphate dehydrogenase (G6PD)-normal, gametocytaemic male participants.
METHODS


This was a phase 2, single-blind, randomised controlled trial done at the Clinical Research Centre of the Malaria Research and Training Centre (MRTC) of the University of Bamako (Bamako, Mali). We enrolled male participants aged 5-50 years with asymptomatic P falciparum malaria. G6PD-normal participants with gametocytes detected by blood smear were randomised 1:1:1:1 in block sizes of eight, using a sealed-envelope design, to receive either sulfadoxine-pyrimethamine and amodiaquine, sulfadoxine-pyrimethamine and amodiaquine plus a single dose of 0·25 mg/kg primaquine, dihydroartemisinin-piperaquine, or dihydroartemisinin-piperaquine plus 15 mg/kg per day methylene blue for 3 days. Laboratory staff, investigators, and insectary technicians were masked to the treatment group and gametocyte density of study participants. The study pharmacist and treating physician were not masked. Participants could request unmasking. The primary efficacy endpoint, analysed in all infected patients with at least one infectivity measure before and after treatment, was median within-person percentage change in mosquito infectivity 2 and 7 days after treatment, assessed by membrane feeding. This study is registered with ClinicalTrials.gov, number NCT02831023.
FINDINGS


Between June 27, 2016, and Nov 1, 2016, 80 participants were enrolled and assigned to the sulfadoxine-pyrimethamine and amodiaquine (n=20), sulfadoxine-pyrimethamine and amodiaquine plus primaquine (n=20), dihydroartemisinin-piperaquine (n=20), or dihydroartemisinin-piperaquine plus methylene blue (n=20) groups. Among participants infectious at baseline (54 [68%] of 80), those in the sulfadoxine-pyrimethamine and amodiaquine plus primaquine group (n=19) had a median 100% (IQR 100 to 100) within-person reduction in mosquito infectivity on day 2, a larger reduction than was noted with sulfadoxine-pyrimethamine and amodiaquine alone (n=12; -10·2%, IQR -143·9 to 56·6; p<0·0001). The dihydroartemisinin-piperaquine plus methylene blue (n=11) group had a median 100% (IQR 100 to 100) within-person reduction in mosquito infectivity on day 2, a larger reduction than was noted with dihydroartemisinin-piperaquine alone (n=12; -6·0%, IQR -126·1 to 86·9; p<0·0001). Haemoglobin changes were similar between gametocytocidal arms and their respective controls. After exclusion of blue urine, adverse events were similar across all groups (59 [74%] of 80 participants had 162 adverse events overall, 145 [90%] of which were mild).
INTERPRETATION


Adding a single dose of 0·25 mg/kg primaquine to sulfadoxine-pyrimethamine and amodiaquine or 3 days of 15 mg/kg per day methylene blue to dihydroartemisinin-piperaquine was highly efficacious for preventing P falciparum transmission. Both primaquine and methylene blue were well tolerated.
FUNDING


Bill & Melinda Gates Foundation, European Research Council.",2018,"After exclusion of blue urine, adverse events were similar across all groups (59 [74%] of 80 participants had 162 adverse events overall, 145 [90%] of which were mild).
","['Between June 27, 2016, and Nov 1, 2016, 80 participants were enrolled and assigned to the', 'enrolled male participants aged 5-50 years with asymptomatic P falciparum malaria', 'G6PD-normal participants with gametocytes detected by blood smear', 'dehydrogenase (G6PD)-normal, gametocytaemic male participants', 'Clinical Research Centre of the Malaria Research and Training Centre (MRTC) of the University of Bamako (Bamako, Mali', 'Mali']","['dihydroartemisinin-piperaquine alone', 'sulfadoxine-pyrimethamine and amodiaquine plus primaquine', 'Primaquine and methylene blue', 'primaquine and methylene blue', 'sulfadoxine-pyrimethamine and amodiaquine, sulfadoxine-pyrimethamine and amodiaquine plus a single dose of 0·25 mg/kg primaquine, dihydroartemisinin-piperaquine, or dihydroartemisinin-piperaquine plus 15 mg/kg per day methylene blue', 'dihydroartemisinin-piperaquine (n=20), or dihydroartemisinin-piperaquine plus methylene blue', 'primaquine to sulfadoxine-pyrimethamine and amodiaquine', 'sulfadoxine-pyrimethamine and amodiaquine', 'glucose-6-phosphate', 'dihydroartemisinin-piperaquine plus methylene blue']","['tolerated', 'mosquito infectivity', 'adverse events', 'Efficacy and safety', 'efficacy and safety', 'Haemoglobin changes']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0557814', 'cui_str': 'Training center (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}]","[{'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0025746', 'cui_str': 'methylthioninium chloride'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0672761', 'cui_str': 'glycerol-6-phosphate transporter'}]","[{'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0030657', 'cui_str': 'infectivity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",80.0,0.226078,"After exclusion of blue urine, adverse events were similar across all groups (59 [74%] of 80 participants had 162 adverse events overall, 145 [90%] of which were mild).
","[{'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Roh', 'Affiliation': 'Global Health Group, Malaria Elimination Initiative, University of California, San Francisco, CA, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA. Electronic address: michelle.roh@ucsf.edu.'}, {'ForeName': 'Halimatou', 'Initials': 'H', 'LastName': 'Diawara', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Almahamoudou', 'Initials': 'A', 'LastName': 'Mahamar', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Harouna M', 'Initials': 'HM', 'LastName': 'Soumare', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Kjerstin', 'Initials': 'K', 'LastName': 'Lanke', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Koualy', 'Initials': 'K', 'LastName': 'Sanogo', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Daouda T', 'Initials': 'DT', 'LastName': 'Kone', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Kalifa', 'Initials': 'K', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Sekouba', 'Initials': 'S', 'LastName': 'Keita', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Djibrilla', 'Initials': 'D', 'LastName': 'Issiaka', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Sekou F', 'Initials': 'SF', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy, Medicine, and Dentistry, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Will J R', 'Initials': 'WJR', 'LastName': 'Stone', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands; Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jimee', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': ""Global Health Group, Malaria Elimination Initiative, University of California, San Francisco, CA, USA; President's Malaria Initiative, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.""}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Müller', 'Affiliation': 'Institute of Public Health, Ruprecht-Karls-University, Heidelberg, Germany.'}, {'ForeName': 'Joelle M', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Srinivasan', 'Affiliation': 'Institute for Health Metrics and Evaluation, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Drakeley', 'Affiliation': 'Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Global Health Group, Malaria Elimination Initiative, University of California, San Francisco, CA, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Chen', 'Affiliation': 'Global Health Group, Malaria Elimination Initiative, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands; Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30044-6']
1278,31617896,Quality of life predicting long-term outcomes in cardiac resynchronization therapy patients.,"AIMS


While improvement in quality of life (QoL) has been widely reported in cardiac resynchronization therapy (CRT) patients, its predictive value is not well-understood. We aimed to assess the predictive role of baseline QoL on long-term heart failure (HF) or death events in mild HF patients enrolled in Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT).
METHODS AND RESULTS


A total of 1791 of 1820 patients had their QoL evaluated at baseline, using the EuroQol-5 dimensions (EQ-5D) and the Kansas City Cardiomyopathy Questionnaires (KCCQ). Kaplan-Meier survival analyses and multivariate Cox models were utilized. Issues within any of the domains of the baseline EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were associated with long-term mortality (median follow-up 5.6 years) (all P < 0.05). Heart failure or death events were predicted by issues in baseline mobility [hazard ratio (HR) = 1.41, P < 0.001], usual activities (HR = 1.41, P < 0.001), and anxiety/depression (HR = 1.21, P = 0.035). The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003). Every 10% increase in the visual analogue scale (0-100) was associated with an 8% lower risk of all-cause mortality (P = 0.006), and a 6% lower risk of HF/death (P = 0.002). Mobility issues also predicted echocardiographic reverse remodelling (-33.08 mL vs. -31.17 mL, P = 0.043). Using the KCCQ, patients in the lower tertile of the clinical summary or physical limitations score had a significantly higher risk of long-term HF or death (P < 0.05).
CONCLUSION


In mild HF patients enrolled in MADIT-CRT, multiple baseline QoL questionnaire domains were predictors of echocardiographic remodelling, long-term all-cause mortality, and HF events.",2019,"The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003).","['cardiac resynchronization therapy patients', 'A total of 1791 of 1820 patients had their QoL evaluated at baseline, using the EuroQol-5 dimensions (EQ-5D) and the Kansas City Cardiomyopathy Questionnaires (KCCQ', 'mild HF patients enrolled in Multicenter Automatic Defibrillator Implantation Trial with']",['Cardiac Resynchronization Therapy (MADIT-CRT'],"['usual activity', 'usual activities', 'risk of HF/death', 'risk of long-term HF or death', 'Quality of life predicting long-term outcomes', 'risk of HF events alone', 'quality of life (QoL', 'long-term mortality', 'baseline EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression', 'anxiety/depression', 'Heart failure or death events', 'visual analogue scale']","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",1820.0,0.125056,"The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003).","[{'ForeName': 'Klaudia Vivien', 'Initials': 'KV', 'LastName': 'Nagy', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Rosero', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Geller', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Kosztin', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz262']
1279,31523039,"Maternal intramuscular dexamethasone versus betamethasone before preterm birth (ASTEROID): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Antenatal corticosteroids given to women before preterm birth improve infant survival and health. However, whether dexamethasone or betamethasone have better maternal, neonatal, and childhood health outcomes remains unclear. We therefore aimed to assess whether administration of antenatal dexamethasone to women at risk of preterm birth reduced the risk of death or neurosensory disability in their children at age 2 years compared with betamethasone. We also aimed to assess whether dexamethasone reduced neonatal morbidity, had benefits for the mother, or affected childhood body size, blood pressure, behaviour, or general health compared with betamethasone.
METHODS


In this multicentre, double-blind, randomised controlled trial, we recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies. Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids. We randomly assigned women (1:1) to receive two intramuscular injections of either 12 mg dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose), 24 h apart. The randomisation schedule used balanced, variable blocks that were stratified by hospital, gestational age, and number of fetuses (singleton or twins). We masked all participants, staff, and assessors to treatment groups. Analyses were by intention to treat. The primary outcome was death or neurosensory disability at age 2 years (corrected for prematurity). This study is registered with ANZCTR, ACTRN12608000631303.
FINDINGS


Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50%) women were assigned to receive dexamethasone and 667 (50%) women were assigned to receive betamethasone. 27 (4%) fetuses, infants, or children in the dexamethasone group and 28 (4%) fetuses, infants, or children in the betamethasone group died before age 2 years. The primary outcome of death or neurosensory disability at age 2 years was determined for 603 (79%) of 763 fetuses whose mothers received dexamethasone and 591 (79%) of 746 fetuses whose mothers received betamethasone. We found a similar incidence of death or neurosensory disability in the dexamethasone (198 [33%] of 603 infants) and betamethasone groups (192 [32%] of 591 infants; adjusted relative risk [adjRR] 0·97, 95% CI 0·83 to 1·13; p=0·66). 18 (3%) of 679 women in the dexamethasone group and 28 of 667 (4%) women in the betamethasone group reported side-effects. Discomfort at the injection site, the most frequent side-effect, was less likely in the dexamethasone group than in the betamethasone group (six [1%] women vs 17 [3%] women; p=0·02).
INTERPRETATION


The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment. Our findings indicate that either antenatal corticosteroid can be given to women before preterm birth to improve infant and child health.
FUNDING


National Health and Medical Research Council (Australia).",2019,The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment.,"['recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies', 'Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids', 'Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50', 'and 667 (50%) women']","['antenatal corticosteroid', 'dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose', 'betamethasone', 'Maternal intramuscular dexamethasone', 'dexamethasone', 'antenatal dexamethasone']","['death or neurosensory disability', 'side-effects', 'incidence of survival without neurosensory disability', 'Discomfort', 'death or neurosensory disability at age 2 years (corrected for prematurity', 'risk of death or neurosensory disability', 'neonatal morbidity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0152150', 'cui_str': 'Pregnancy, Twin'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0108964', 'cui_str': 'Celestone Chronodose'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",679.0,0.56823,The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment.,"[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand; School of Medicine, The University of Adelaide, Adelaide, SA, Australia. Electronic address: c.crowther@auckland.ac.nz.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Chad C', 'Initials': 'CC', 'LastName': 'Andersen', 'Affiliation': ""Department of Perinatal Medicine, Women's and Children's Hospital, Adelaide, SA, Australia.""}, {'ForeName': 'Philippa F', 'Initials': 'PF', 'LastName': 'Middleton', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Thach', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Osteoporosis and Bone Biology, Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Department of Obstetrics and Gynaecology, The Royal Women's Hospital and Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Robinson', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30292-5']
1280,31368191,"Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial.","Recent studies demonstrated the utility of perineural injection with platelet-rich plasma (PRP) and 5% dextrose (D5W) as novel strategies for treatment of carpal tunnel syndrome (CTS). The present study comprised a prospective, randomized, single-blind, head-to head comparative trial to compare the 6-month outcome of perineural injection with PRP or D5W in patients with moderate CTS. Fifty-two patients with unilateral moderate CTS were enrolled and randomized into two groups: The PRP group received a single 3-cc perineural injection of PRP under ultrasound guidance, and dextrose group received a single 3-cc perineural injection of D5W under ultrasound guidance. The Boston Carpal Tunnel Syndrome Questionnaire score was used as the primary outcome. Secondary outcomes included cross-sectional area (CSA) of the median nerve and electrophysiological assessments. Evaluations were performed at baseline and at 1, 3, and 6 months postinjection. All patients (26 patients per group) completed the study. Compared with the dextrose group, the PRP group demonstrated significant reductions in Boston Carpal Tunnel Syndrome Questionnaire function at 3 months (p = .044), distal motor latency at 6 months (p = .028), and CSA at 3 and 6 months (p = .010 and.018, respectively). A single perineural injection of PRP reduced the CSA of the median nerve more effectively than injection of D5W at 3 and 6 months postinjection for patients with moderate CTS.",2019,A single perineural injection of PRP reduced the CSA of the median nerve more effectively than injection of D5W at 3 and 6 months postinjection for patients with moderate CTS.,"['All patients (26 patients per group) completed the study', 'patients with moderate CTS', 'carpal tunnel syndrome (CTS', 'Fifty-two patients with unilateral moderate CTS', 'moderate carpal tunnel syndrome']","['PRP', 'single 3-cc perineural injection of PRP under ultrasound guidance, and dextrose group received a single 3-cc perineural injection of D5W under ultrasound guidance', 'dextrose', 'perineural injection with platelet-rich plasma (PRP) and 5% dextrose (D5W', 'perineural platelet-rich plasma and dextrose injections', 'perineural injection with PRP or D5W']","['distal motor latency', 'Boston Carpal Tunnel Syndrome Questionnaire score', 'cross-sectional area (CSA) of the median nerve and electrophysiological assessments', 'Boston Carpal Tunnel Syndrome Questionnaire function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031843', 'cui_str': 'function'}]",52.0,0.025784,A single perineural injection of PRP reduced the CSA of the median nerve more effectively than injection of D5W at 3 and 6 months postinjection for patients with moderate CTS.,"[{'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Ying', 'Initials': 'TY', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Chou', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Ming-Jen', 'Initials': 'MJ', 'LastName': 'Ke', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Yung-Tsan', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.2950']
1281,29290087,Does Mild Hydronephrosis Induced by Full-Bladder Improve Outcomes in Patients Undergoing Shock Wave Lithotripsy for Lower Calyceal Stones?: A Prospective Randomized Study.,"PURPOSE


To compare the outcomes, sessions and shock wave numbers in patients undergoing standard procedure shock wave lithotripsy (SWL) and patients undergoing SWL with mild hydronephrosis induced by full-bladderfollowing oral hydration before SWL procedure for lower calyceal stones.
MATERIALS AND METHODS


Between January 2014- January 2016 a total of 371 patients who underwent SWL, for lower pole calyceal stones ? 2 cm, were included into the study. 127 patients were treated in the supine position (Group A), 123 in the prone position (Group B) and 121 in the prone position with full bladder and mild hydronephrosis checked by ultrasound before procedure (Group C). There were 286 men and 85 women with a mean ± SD age of 36 ± 11 yearsResults: The mean (SD) stone sizes within the group A, group B and group C were 11 mm (±3 mm), 12 mm (±4.1 mm) and 11 mm (± 3.8 mm) respectively. No significant difference was found in age (P = .18) and stone size between 3 groups (P = .07). The median interquartile range (IQR) number of shocks within the group A, group B and group C were 7600 (3855), 6500 (4300) and 6700 (4915) respectively. Significant difference was found in number of shock waves among 3 groups (P < .01). The difference between groups according to stone expulsion rate wasfound significant in all sessions (P = .01).
CONCLUSION


The present study suggests that mild hydronephrotic status induced by full-bladder before SWL can lower cost and patient discomfort by decrease in number of sessions and increase in stone clearance.",2018,"The difference between groups according to stone expulsion rate wasfound significant in all sessions (P = .01).
","['Between January 2014- January 2016 a total of 371 patients who underwent SWL, for lower pole calyceal stones ', 'Patients Undergoing', 'patients undergoing standard procedure shock wave lithotripsy (SWL) and patients undergoing SWL with mild hydronephrosis induced by full-bladderfollowing oral hydration before SWL procedure for lower calyceal stones', '127 patients were treated in the supine position (Group A), 123 in the prone position (Group B) and 121 in the prone position with full bladder and mild hydronephrosis checked by ultrasound before procedure (Group C', '286 men and 85 women with a mean ± SD age of 36 ± 11 yearsResults']",['Shock Wave Lithotripsy'],"['stone expulsion rate', 'stone clearance', 'stone size', 'number of shock waves', 'median interquartile range (IQR) number of shocks', 'mean (SD) stone sizes']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337815', 'cui_str': 'Poles (ethnic group)'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus (disorder)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0033422', 'cui_str': 'Prone Position'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0585032', 'cui_str': 'Before procedure (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",127.0,0.105074,"The difference between groups according to stone expulsion rate wasfound significant in all sessions (P = .01).
","[{'ForeName': 'Ismet Aydin', 'Initials': 'IA', 'LastName': 'Hazar', 'Affiliation': 'Department of Urology, Taksim Research and Training Hospital, Istanbul, Turkey. mdhazar@gmail.com.'}, {'ForeName': 'Basri', 'Initials': 'B', 'LastName': 'Cakiroglu', 'Affiliation': 'Department Urology, Hisar Intercontinental Hospital, Istanbul, Turkey.'}, {'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Sinanoglu', 'Affiliation': 'Department of Urology, Maltepe University, Istanbul, Turkey.'}, {'ForeName': 'Feride Sinem', 'Initials': 'FS', 'LastName': 'Akgün', 'Affiliation': 'Department of Emergency Clinic, Maltepe University, Istanbul, Turkey.'}, {'ForeName': 'Ersan', 'Initials': 'E', 'LastName': 'Arda', 'Affiliation': 'Department of Urology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Ilkan', 'Initials': 'I', 'LastName': 'Yuksel', 'Affiliation': 'Department of Urology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Akdere', 'Affiliation': 'Department of Urology, Trakya University, Edirne, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.3923']
1282,29250762,Evaluation the result of warm normal saline irrigation in ureteral endoscopic surgeries.,"PURPOSE


Transurethral lithotripsy (TUL) is a major modality for the endoscopic management of ureteral stones. Ureteral spasm makes access for ureters difficult, which causes impaction of the ureteroscope, ureteral dislodge, and a low success rate of endoscopic surgeries. This study described the outcomes of a new endoscopic surgical experience by use of 40-degree warm saline irrigation during TUL compaired with routine ambient air irrigation in TUL.
MATERIALS AND METHODS


In this randomized clinical trial from 2014 to 2015, 150 patients with ureteral stone with balanced randomization were divided into two parallel groups. Patients underwent TUL in the first group with 20-25 degree saline irrigation and in the second group with 40-degree saline irrigation. One surgical team with the same semi-rigid instrument performed all TULs and the other steps were similar in both groups. Complete stone fragmentation was measured as the primary outcome and the duration of procedure, retrograde stone migration and all and any intraoperative complications were the secondary measurements.
RESULT


While comparing warm saline irrigation with cold saline irrigation, the rate of access to upper ureter was 95% versus 72%, stone retropulsion frequency was 10.7% versus 30.7% and the stone-free rate was 96% versus 76% respectively (P < .05). There was no ureteroscope impaction and ureteral dislodge in both groups.
CONCLUSION


Using warm saline irrigation in endoscopic surgeries results in better surgical outcomes including a lower ureteral spasm rate, greater ureteral muscle relaxation and better access to the upper ureteral zone, and a lower rate of complications, such as ureteroscope impaction, ureteral dislodge and stone retropulsion.",2018,"Using warm saline irrigation in endoscopic surgeries results in better surgical outcomes including a lower ureteral spasm rate, greater ureteral muscle relaxation and better access to the upper ureteral zone, and a lower rate of complications, such as ureteroscope impaction, ureteral dislodge and stone retropulsion.","['ureteral endoscopic surgeries', '2014 to 2015, 150 patients with ureteral stone with balanced randomization']","['warm normal saline irrigation', 'Transurethral lithotripsy (TUL', 'TUL', '40-degree saline irrigation', '40-degree warm saline irrigation', 'warm saline irrigation']","['rate of access to upper ureter', 'stone-free rate', 'ureteroscope impaction and ureteral dislodge', 'ureteral spasm rate, greater ureteral muscle relaxation', 'Complete stone fragmentation', 'duration of procedure, retrograde stone migration and all and any intraoperative complications', 'stone retropulsion frequency']","[{'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0184213', 'cui_str': 'Ureteroscopes'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}, {'cui': 'C0948226', 'cui_str': 'Ureteral spasm'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0277845', 'cui_str': 'Retropulsion (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",150.0,0.0491624,"Using warm saline irrigation in endoscopic surgeries results in better surgical outcomes including a lower ureteral spasm rate, greater ureteral muscle relaxation and better access to the upper ureteral zone, and a lower rate of complications, such as ureteroscope impaction, ureteral dislodge and stone retropulsion.","[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mohammadzadeh Rezaei', 'Affiliation': 'Department of Urology, Mashhad University of Medical Sciences, Mashhad-IRAN.. mohammadzadehma@mums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Akhavan Rezayat', 'Affiliation': 'Department of Urology, Mashhad University of Medical Sciences, Mashhad-IRAN.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Tavakoli', 'Affiliation': 'Department of Urology, Mashhad University of Medical Sciences, Mashhad-IRAN.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Jarahi', 'Affiliation': 'Department of Community Medicine, Mashhad University of Medical Sciences, Mashhad-IRAN.'}]",Urology journal,['10.22037/uj.v0i0.3872']
1283,31613965,Impaired Respiratory Function in Women With PCOS Compared With Matched Controls From a Population-Based Study.,"CONTEXT


Increased prevalence of asthma has been reported from epidemiological studies in women with polycystic ovary syndrome (PCOS).
OBJECTIVE


To investigate respiratory function in women with PCOS compared with controls in a clinical setting.
DESIGN


An 8-year clinical follow-up study including self-reported asthma diagnoses and spirometry of women with PCOS randomized to metformin or placebo during pregnancy in the original studies (the Pilot and the PregMet-study), compared with matched controls from a population-based cohort study (The HUNT Study).
SETTING


Secondary and tertiary care centers.
PARTICIPANTS


A total of 145 women with PCOS (54% of original cohort) were matched 1:3 to controls, on gender, age, and smoking-status.
MAIN OUTCOMES AND MEASURES


Self-reported doctor-diagnosed asthma (DDA), percentage of predicted forced expiratory volume in the first second of expiration (FEV1 % predicted), percentage of predicted forced vital capacity (FVC % predicted).
RESULTS


Women with PCOS reported more DDA compared with controls (19% vs 9%; P < 0.01). Spirometry indicated a combined obstructive (FEV1 % predicted, 93.7 vs 102.0; P < 0.01) and restrictive (FVC % predicted, 94.5 vs 103.7; P < 0.01) respiratory impairment in PCOS compared with controls. Metformin in pregnancy did not affect respiratory function at follow-up.
CONCLUSION


Women with PCOS reported higher prevalence of DDA compared with controls matched for age and smoking status. In addition, respiratory function was decreased, with both obstructive and restrictive components. Further insight to the underlying pathogenesis of these observations is needed.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: The PregMet study: NCT00159536. The Pilot study: NCT03259919.",2020,"RESULTS


Women with PCOS reported more DDA compared to controls (19% vs 9%, p<0.01).","['Secondary and tertiary care centers', 'women with PCOS compared to controls in a clinical setting', '145 women with PCOS (54% of original cohort) were matched 1:3 to controls, on gender, age and smoking-status', 'matched controls from a population-based cohort study (The HUNT Study', '8-year clinical follow-up including self-reported asthma diagnoses and spirometry of women with PCOS randomized to', 'women with PCOS']","['metformin or placebo', 'Metformin']","['Self-reported doctor diagnosed asthma (DDA), FEV1 % predicted, FVC % predicted', 'DDA', 'respiratory function', 'respiratory impairment in PCOS', 'prevalence of DDA']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4255216', 'cui_str': 'Hunting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0106487', 'cui_str': 'DDA'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",145.0,0.20856,"RESULTS


Women with PCOS reported more DDA compared to controls (19% vs 9%, p<0.01).","[{'ForeName': 'Maria Othelie', 'Initials': 'MO', 'LastName': 'Underdal', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Anne Hildur', 'Initials': 'AH', 'LastName': 'Henriksen', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Internal Medicine, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz053']
1284,29239658,Working memory training in older adults: Bayesian evidence supporting the absence of transfer.,"The question of whether working memory training leads to generalized improvements in untrained cognitive abilities is a longstanding and heatedly debated one. Previous research provides mostly ambiguous evidence regarding the presence or absence of transfer effects in older adults. Thus, to draw decisive conclusions regarding the effectiveness of working memory training interventions, methodologically sound studies with larger sample sizes are needed. In this study, we investigated whether or not a computer-based working memory training intervention induced near and far transfer in a large sample of 142 healthy older adults (65 to 80 years). Therefore, we randomly assigned participants to either the experimental group, which completed 25 sessions of adaptive, process-based working memory training, or to the active, adaptive visual search control group. Bayesian linear mixed-effects models were used to estimate performance improvements on the level of abilities, using multiple indicator tasks for near (working memory) and far transfer (fluid intelligence, shifting, and inhibition). Our data provided consistent evidence supporting the absence of near transfer to untrained working memory tasks and the absence of far transfer effects to all of the assessed abilities. Our results suggest that working memory training is not an effective way to improve general cognitive functioning in old age. (PsycINFO Database Record",2017,The question of whether working memory training leads to generalized improvements in untrained cognitive abilities is a longstanding and heatedly debated one.,"['142 healthy older adults (65 to 80 years', 'older adults']","['computer-based working memory training intervention', 'working memory training', 'adaptive, process-based working memory training, or to the active, adaptive visual search control group', 'Working memory training']","['general cognitive functioning', 'level of abilities, using multiple indicator tasks for near (working memory) and far transfer (fluid intelligence, shifting, and inhibition']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",142.0,0.056346,The question of whether working memory training leads to generalized improvements in untrained cognitive abilities is a longstanding and heatedly debated one.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Guye', 'Affiliation': 'University Research Priority Program, University of Zurich.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'von Bastian', 'Affiliation': 'Department of Psychology, Bournemouth University.'}]",Psychology and aging,['10.1037/pag0000206']
1285,29277883,Effects of Different Anesthetic Agents on Surgical Site Hemorrhage During Circumcision.,"PURPOSE


To investigate the effects of ketamine+midazolam and propofol+sevoflurane anesthesia on surgical site hemorrhage during circumcision procedures.
MATERIALS AND METHODS


The boys undergoing circumcision surgery were included in the study. The patients were divided into two groups. In Group 1 (n = 50), 0.01 mg/kg midazolam and 2 mg/kg IV ketamine were administered. In Group 2 (n = 50), 1 ?g/kg fentanyl, 1 mg/kg lidocaine 2%, and 2-3 mg/kg IV propofol were administered, and patency of airway was ensured with a laryngeal mask airway. The intraoperative bleeding scale was recorded during the procedure to evaluate surgical site bleeding. Hemorrhage was checked for the first three hours using the postoperative bleeding scale to follow the amount of hemorrhage.
RESULTS


Intraoperative bleeding scores were significantly higher in Group 1 as compared to Group 2. However, there was no significant difference between the groups regarding frequency of postoperative hemorrhage. Themean blood pressure values measured at 5th, 10th, 15th minutes and recovery room were significantly higher in Group 1.
CONCLUSION


The intraoperative bleeding scores were significantly higher with ketamine+midazolam compared to propofol+sevoflurane. On the other hand this hemorrhage can be controlled easily with appropriate hemostasis, and the amount of blood loss was not clinically significant. We think that our study makes a positive contribution to the literature about the effects of anesthetics on the surgical site bleeding during circumcision.
CLINICAL TRIALS REGISTRATION


ACTRN12616000189426.",2018,The intraoperative bleeding scores were significantly higher with ketamine+midazolam compared to propofol+sevoflurane.,"['boys undergoing circumcision surgery', 'Surgical Site Hemorrhage During Circumcision']","['ketamine', 'ketamine+midazolam', 'midazolam', 'lidocaine', 'ketamine+midazolam and propofol+sevoflurane anesthesia', 'propofol+sevoflurane']","['Intraoperative bleeding scores', 'blood loss', 'Themean blood pressure values', 'Hemorrhage', 'postoperative bleeding scale', 'surgical site hemorrhage', 'intraoperative bleeding scale', 'frequency of postoperative hemorrhage', 'intraoperative bleeding scores']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0222045'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}]",50.0,0.0356675,The intraoperative bleeding scores were significantly higher with ketamine+midazolam compared to propofol+sevoflurane.,"[{'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Karasu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey. drderyatopuz@gmail.com.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey.'}, {'ForeName': 'Seyda Efsun', 'Initials': 'SE', 'LastName': 'Ozgunay', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey.'}, {'ForeName': 'Isra', 'Initials': 'I', 'LastName': 'Karaduman', 'Affiliation': 'Department of Anesthesiology and Reanimation, Gaziemir Government Hospital, Izmir 35410, Turkey.'}, {'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Ozer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Savsat Government Hospital, Artvin 08700, Turkey.'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Kaya', 'Affiliation': 'Department of Pediatric Surgery, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.3882']
1286,30824268,Medium-chain fatty acids lower postprandial lipemia: A randomized crossover trial.,"Epidemiological and interventional studies have linked saturated fatty acids (SFA) with elevated levels of low-density lipoprotein cholesterol (LDL-C) and increased CVD risk. However, the effects of the SFA chain length on postprandial lipemia in humans are not well elucidated. The aim of this study was to investigate the impact of short, medium and long-chain SFA on postprandial blood lipids in healthy volunteers. Sixteen healthy volunteers consumed test biscuits containing 40 g of either butter (BB), coconut oil (CB) or lard (LB) in a single-blinded, randomized crossover design. Blood samples were collected fasting and 2, 3, 4, and 6 hours postprandially and assessed for blood lipids (total cholesterol, TC; high-density lipoprotein cholesterol, HDL-C; LDL-C and triglyceride, TG). The postprandial TG response following CB was 59.8% lower than following BB (p < 0.01) and 58.8% lower than LB (p < 0.01), although no difference was observed between the BB and the LB responses. The net area under the LDL-C concentration curve was significantly larger after consumption of the CB compared to the BB, despite no significant differences in postprandial net area under the TC and HDL-C concentration curves. Consumption of medium-chain SFA as CB resulted in lower postprandial TG excursions compared to short-chain SFA as BB and long-chain SFA as LB, despite their identical fat and caloric content. These results suggest that SFA differ in their potential to elevate postprandial lipid levels, and that coconut oil, a rich source of medium-chain SFA may not be as hyperlipidemic as animal fats rich in long chain SFA. ANZCTR IDENTIFIER: 12617000903381. CLINICAL TRIAL REGISTRY NUMBER: The study was registered with the Australia New Zealand Trial registry as ACTRN12617000903381.",2020,"The postprandial TG response following CB was 59.8% lower than following BB (p < 0.01) and 58.8% lower than LB (p < 0.01), although no difference was observed between the BB and the LB responses.","['healthy volunteers', 'Sixteen healthy volunteers']","['medium and long-chain SFA', 'test biscuits containing 40\xa0g of either butter (BB), coconut oil (CB) or lard (LB', 'Medium-chain fatty acids']","['low-density lipoprotein cholesterol (LDL-C) and increased CVD risk', 'postprandial blood lipids', 'net area under the LDL-C concentration curve', 'postprandial net area under the TC and HDL-C concentration curves', 'blood lipids (total cholesterol, TC; high-density lipoprotein cholesterol, HDL-C; LDL-C and triglyceride, TG', 'postprandial TG excursions', 'postprandial TG response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0056060', 'cui_str': 'Coconut Oil'}, {'cui': 'C0064658', 'cui_str': 'lard'}, {'cui': 'C0522094', 'cui_str': 'Medium chain fatty acid'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",16.0,0.102783,"The postprandial TG response following CB was 59.8% lower than following BB (p < 0.01) and 58.8% lower than LB (p < 0.01), although no difference was observed between the BB and the LB responses.","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Panth', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, 305C Medical Science Building, Callaghan, NSW 2308, Australia. Electronic address: nisha.panth@uon.edu.au.'}, {'ForeName': 'Cintia B', 'Initials': 'CB', 'LastName': 'Dias', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, 305C Medical Science Building, Callaghan, NSW 2308, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: cintia.dias@uon.edu.au.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Wynne', 'Affiliation': 'Department of Diabetes & Endocrinology, School of Medicine and Public Health, Hunter Medical Research Institute, University of Newcastle, New Lambton, NSW 2310, Australia. Electronic address: katie-jane.wynne@hnehealth.nsw.gov.au.'}, {'ForeName': 'Harjinder', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: h.singh@massey.ac.nz.'}, {'ForeName': 'Manohar L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, 305C Medical Science Building, Callaghan, NSW 2308, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: manohar.garg@newcastle.edu.au.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.008']
1287,31259488,A Multicenter Trial of Vena Cava Filters in Severely Injured Patients.,"BACKGROUND


Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known.
METHODS


In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met.
RESULTS


The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients.
CONCLUSIONS


Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).",2019,"Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98).","['Severely Injured Patients', '240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed', '46 patients in the', 'severely injured patients who have a contraindication to prophylactic anticoagulation is not known']","['vena cava filter', 'inferior vena cava filter', 'mandatory computed tomographic pulmonary angiography', 'Vena Cava Filters']","['median Injury Severity Score', 'symptomatic pulmonary embolism or death', 'pulmonary embolism', 'symptomatic pulmonary embolism', 'prophylactic anticoagulation', 'pulmonary embolism or death', 'composite of symptomatic pulmonary embolism or death']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0080306', 'cui_str': 'Inferior Vena Cava Filters'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0080306', 'cui_str': 'Inferior Vena Cava Filters'}, {'cui': 'C0677490', 'cui_str': 'Pulmonary angiogram'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",240.0,0.218804,"Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98).","[{'ForeName': 'Kwok M', 'Initials': 'KM', 'LastName': 'Ho', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Honeybul', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Zellweger', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Wibrow', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lipman', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Holley', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kop', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Geelhoed', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Corcoran', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Misur', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Edibam', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Ross I', 'Initials': 'RI', 'LastName': 'Baker', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chamberlain', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Forsdyke', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}, {'ForeName': 'Frederick B', 'Initials': 'FB', 'LastName': 'Rogers', 'Affiliation': ""From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).""}]",The New England journal of medicine,['10.1056/NEJMoa1806515']
1288,30981954,"Development and validation of a simple, fast, and sensitive LC/MS/MS method for the quantification of oxfendazole in human plasma and its application to clinical pharmacokinetic study.","The most popular standard treatments for soil transmitted helminths in humans including mebendazole, albendazole, levamisole, and pyrantel pamoate, show greatly variable efficacy against different species of parasites and have unfavorable pharmacokinetic characteristics, such as short half-life. The transition of oxfendazole, a potent broad-spectrum anthelmintic with long half-life, from veterinary medicine to human use has been considered as a promising approach. However, analytical methods for the quantitative detection of oxfendazole in human matrix are very limited and lack sensitivity. In this study, we have developed a high-performance liquid chromatography-tandem mass spectrometry (LC/MS/MS) method for the quantification of oxfendazole in human plasma using albendazole as an internal standard. The established method was fully validated with lower limit of quantitation (LLOQ) of 0.5 ng/mL and linearity in the range of 0.5-1000 ng/mL; intra-day and inter-day accuracies ranged from 2.6 to 9.5% for 3 quality control levels (1.5 ng/mL, 75 ng/mL, and 750 ng/mL) and LLOQ; intra-day and inter-day precision was ≤13.6% for quality controls and ≤15.1% for LLOQ; matrix factor and extraction recovery were consistent with coefficient of variation of less than 15.0%. Other parameters including matrix selectivity, injection carryover, reinjection reproducibility, hemolysis effect, interference of analyte with internal standard, dilution integrity, freeze/thaw stability, whole blood stability, and stock solution stability were also validated and met the acceptance criteria. The assay was successfully applied to quantify oxfendazole plasma concentration in healthy adult volunteers after the administration of multiple oral doses of oxfendazole.",2019,The assay was successfully applied to quantify oxfendazole plasma concentration in healthy adult volunteers after the administration of multiple oral doses of oxfendazole.,['healthy adult volunteers'],"['oxfendazole', 'albendazole', 'mebendazole, albendazole, levamisole']","['matrix selectivity, injection carryover, reinjection reproducibility, hemolysis effect, interference of analyte with internal standard, dilution integrity, freeze/thaw stability, whole blood stability, and stock solution stability', 'limit of quantitation (LLOQ']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0069761', 'cui_str': 'oxfendazole'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0025023', 'cui_str': 'Mebendazole'}, {'cui': 'C0023556', 'cui_str': 'Levamisole'}]","[{'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443354', 'cui_str': 'Analyte (substance)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",,0.0456254,The assay was successfully applied to quantify oxfendazole plasma concentration in healthy adult volunteers after the administration of multiple oral doses of oxfendazole.,"[{'ForeName': 'Thanh', 'Initials': 'T', 'LastName': 'Bach', 'Affiliation': 'Division of Pharmaceutics and Translational Therapeutics, College of Pharmacy, University of Iowa, IA, 52242, USA.'}, {'ForeName': 'SoHyun', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'College of Pharmacy, University of Iowa, IA, 52242, USA.'}, {'ForeName': 'Ronilda', 'Initials': 'R', 'LastName': ""D'Cunha"", 'Affiliation': 'Division of Pharmaceutics and Translational Therapeutics, College of Pharmacy, University of Iowa, IA, 52242, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Winokur', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, IA, 52242, USA.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'An', 'Affiliation': 'Division of Pharmaceutics and Translational Therapeutics, College of Pharmacy, University of Iowa, IA, 52242, USA. Electronic address: guohua-an@uiowa.edu.'}]",Journal of pharmaceutical and biomedical analysis,['10.1016/j.jpba.2019.03.048']
1289,31599019,l-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients.,"BACKGROUND AND AIMS


The effect of perioperative treatment with l-carnitine in hepatectomized patients is unclear. The objective of the current study is to evaluate the short-term outcomes after liver cancer surgery in patients treated with l-carnitine compared with nontreated patients.
METHODS


Patients with primary liver malignancies scheduled to undergo a hepatectomy were randomly assigned to receive either perioperative treatment with l-carnitine (carnitine group) or usual intake (control group). The primary endpoint of this study was the short-term outcome after liver surgery.
RESULTS


The study participants were randomly assigned into 2 groups: 106 patients in the control group and 102 patients in the perioperative l-carnitine supplementation group. The restoration of serum ammonia levels, prothrombin time, and peripheral neutrophil count at 3 days after the operation was significantly faster in the carnitine group than in the control group. Fewer patients in the carnitine group developed grade B posthepatic liver failure, according to the grading system of the International Study Group of Liver Surgery, than patients in the control group (20% vs 76%). The length of hospitalization was significantly shorter in patients in the carnitine group than in those in the control group.
CONCLUSIONS


We found that perioperative treatment with l-carnitine was significantly better than ordinary treatment in reducing postoperative serum ammonia levels, suggesting that l-carnitine may serve as a pivotal regulator of liver injury and repair and result in shorter postoperative hospitalization (ClinicalTrials.gov trial registration no. NCT03021876).",2020,"We found that perioperative treatment with l-carnitine was significantly better than ordinary treatment in reducing postoperative serum ammonia levels, suggesting that l-carnitine may serve as a pivotal regulator of liver injury and repair and result in shorter postoperative hospitalization (ClinicalTrials.gov trial registration","['patients treated with l-carnitine compared with nontreated patients', 'Hepatectomized Patients', '106 patients in the control group and 102 patients in the', 'Patients with primary liver malignancies scheduled to undergo a hepatectomy', 'hepatectomized patients']","['l-Carnitine', 'l-carnitine', 'perioperative treatment with l-carnitine (carnitine group) or usual intake (control group', 'perioperative l-carnitine supplementation group', 'carnitine']","['Postoperative Liver Function', 'grade B posthepatic liver failure', 'postoperative serum ammonia levels', 'length of hospitalization', 'restoration of serum ammonia levels, prothrombin time, and peripheral neutrophil count', 'short-term outcome after liver surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0441806', 'cui_str': 'Grade B (qualifier value)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201879', 'cui_str': 'Ammonia measurement (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",106.0,0.0387063,"We found that perioperative treatment with l-carnitine was significantly better than ordinary treatment in reducing postoperative serum ammonia levels, suggesting that l-carnitine may serve as a pivotal regulator of liver injury and repair and result in shorter postoperative hospitalization (ClinicalTrials.gov trial registration","[{'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Okabayashi', 'Affiliation': 'Department of Gastroenterological Surgery, Kōchi Health Sciences Center, Kōchi, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Sui', 'Affiliation': 'Department of Gastroenterological Surgery, Kōchi Health Sciences Center, Kōchi, Japan.'}, {'ForeName': 'Takatsugu', 'Initials': 'T', 'LastName': 'Mastumoto', 'Affiliation': 'Department of Gastroenterological Surgery, Kōchi Health Sciences Center, Kōchi, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Iwata', 'Affiliation': 'Department of Diagnostic Pathology, Kōchi Health Sciences Center, Kōchi, Japan.'}, {'ForeName': 'Sojiro', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Radiology, Kōchi Health Sciences Center, Kōchi, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Iiyama', 'Affiliation': 'Department of Biostatistics, National Center for Global Health and Medicine, Kōchi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Clinical Oncology at Kōchi Health Sciences Center, Kōchi, Japan.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1720']
1290,31597534,Comparison of the Effects of 2 Surgical Techniques Used in the Treatment of Concha Bullosa on Olfactory Functions.,"INTRODUCTION


Concha bullosa (CB), which is pneumatization of the concha, is one of the most commonly seen anatomic variations of the lateral nasal wall.
OBJECTIVE


To investigate the effects on olfactory function of lateral turbinectomy and crushing methods used in the surgical treatment of CB.
METHODS


The study included a total of 47 patients operated on for a diagnosis of CB and nasal septum deviation. The patients comprised 22 females and 25 males, with bilateral CB in 18 cases and unilateral in 29 cases. Intervention was made to a total of 65 CB. The cases were separated as those applied with septoplasty and lateral turbinectomy in group 1 (n = 34) and those applied with the septoplasty and crushing method in group 2 (n = 31). The olfactory function of the patients was evaluated preoperatively and at 3 months postoperatively with the Brief Smell Identification Test.
RESULTS


A statistically significant increase was determined in the postoperative smell test results compared with the preoperative values in both group 1 ( P  = .021) and group 2 ( P  = .001). When the change in the smell test results from preoperative to postoperative was compared between the groups, the increase in group 2 was determined to be statistically significantly greater ( P  = .002).
CONCLUSION


The results of this study showed that the crushing method in surgical treatment of CB increased olfactory functions more than the lateral resection method, and as the improvement in olfactory functions was greater, this demonstrated that only increasing the nasal cavity is not sufficient and the nasal mucosa should be protected as far as possible.",2020,"RESULTS


A statistically significant increase was determined in the postoperative smell test results compared with the preoperative values in both group 1 ( P  = .021) and group 2 ( P  = .001).","['The study included a total of 47 patients operated on for a diagnosis of CB and nasal septum deviation', 'patients comprised 22 females and 25 males, with bilateral CB in 18 cases and unilateral in 29 cases']",[],"['postoperative smell test', 'olfactory functions']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum (disorder)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",65.0,0.0131735,"RESULTS


A statistically significant increase was determined in the postoperative smell test results compared with the preoperative values in both group 1 ( P  = .021) and group 2 ( P  = .001).","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Akkoca', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Ministry of Health, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Tüzüner', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Ministry of Health, Başkent Üniversity, Ankara, Turkey.'}, {'ForeName': 'Ceren Ersöz', 'Initials': 'CE', 'LastName': 'Ünlü', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Ministry of Health, Gulhane Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Gökçe', 'Initials': 'G', 'LastName': 'Şimşek', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Ministry of Health, Kırıkkale Üniversity, Ankara, Turkey.'}, {'ForeName': 'Selda Kargın', 'Initials': 'SK', 'LastName': 'Kaytez', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Ministry of Health, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Gülay Aktar', 'Initials': 'GA', 'LastName': 'Uğurlu', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Ministry of Health, Ankara Training and Research Hospital, Ankara, Turkey.'}]","Ear, nose, & throat journal",['10.1177/0145561319881061']
1291,23242542,Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women.,"BACKGROUND


Cervical cancer is a major public health problem for women in sub-Saharan Africa. Availability of a human papillomavirus (HPV) vaccine could have an important public health impact.
METHODS


In this phase IIIb, double-blind, randomized, placebo-controlled, multicenter trial (NCT00481767), healthy African girls and young women seronegative for human immunodeficiency virus (HIV) were stratified by age (10-14 or 15-25 years) and randomized (2:1) to receive either HPV-16/18 AS04-adjuvanted vaccine (n = 450) or placebo (n = 226) at 0, 1, and 6 months. The primary objective was to evaluate HPV-16/18 antibody responses at month 7. Seropositivity rates and corresponding geometric mean titers (GMTs) were measured by enzyme-linked immunosorbent assay.
RESULTS


In the according-to-protocol analysis at month 7, 100% of initially seronegative participants in the vaccine group were seropositive for both anti-HPV-16 and anti-HPV-18 antibodies (n = 130 and n = 128 for 10-14-year-olds, respectively; n = 190 and n = 212 for 15-25-year-olds). GMTs for HPV-16 and HPV-18 were higher in 10-14-year-olds (18 423 [95% confidence interval, 16 185-20 970] and 6487 [5590-7529] enzyme-linked immunosorbent assay units (EU)/mL, respectively) than in 15-25-year-olds (10 683 [9567-11 930] and 3743 [3400-4120] EU/mL, respectively). Seropositivity was maintained at month 12. No participant withdrew owing to adverse events. No vaccine-related serious adverse events were reported.
CONCLUSIONS


The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had a clinically acceptable safety profile when administered to healthy HIV-seronegative African girls and young women.",2013,The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had a clinically acceptable safety profile when administered to healthy HIV-seronegative African girls and young women.,"['healthy African girls and young women seronegative for human immunodeficiency virus (HIV) were stratified by age (10-14 or 15-25 years', 'healthy HIV-seronegative African girls and young women', '10-25-year-old HIV-Seronegative African girls and young women', 'women in sub-Saharan Africa']","['HPV-16/18 AS04-adjuvanted vaccine', 'placebo', 'human papillomavirus-16/18 AS04-adjuvanted vaccine', 'human papillomavirus (HPV) vaccine']","['Safety and immunogenicity', 'Seropositivity rates and corresponding geometric mean titers (GMTs', 'Seropositivity', 'HPV-16/18 antibody responses']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",,0.643201,The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had a clinically acceptable safety profile when administered to healthy HIV-seronegative African girls and young women.,"[{'ForeName': 'Papa Salif', 'Initials': 'PS', 'LastName': 'Sow', 'Affiliation': 'CHU Fann, Service des Maladies Infectieuses, Dakar (Fann), Senegal.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Watson-Jones', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Kiviat', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Changalucha', 'Affiliation': ''}, {'ForeName': 'Khardiata Diallo', 'Initials': 'KD', 'LastName': 'Mbaye', 'Affiliation': ''}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Kouro', 'Initials': 'K', 'LastName': 'Bousso', 'Affiliation': ''}, {'ForeName': 'Bazil', 'Initials': 'B', 'LastName': 'Kavishe', 'Affiliation': ''}, {'ForeName': 'Aura', 'Initials': 'A', 'LastName': 'Andreasen', 'Affiliation': ''}, {'ForeName': 'Macoumba', 'Initials': 'M', 'LastName': 'Toure', 'Affiliation': ''}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mayaud', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lebacq', 'Affiliation': ''}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Herazeh', 'Affiliation': ''}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Descamps', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jis619']
1292,31603191,Personalized antiplatelet therapy guided by a novel detection of platelet aggregation function in stable coronary artery disease patients undergoing percutaneous coronary intervention: a randomized controlled clinical trial.,"AIMS


A number of studies have attempted to demonstrate the benefits associated with personalized antiplatelet therapy guided by platelet function testing, which has led to disappointing findings. In this study, we used a new platelet function test to guide antiplatelet therapy in stable coronary artery disease (CAD) patients after percutaneous coronary intervention (PCI).
METHODS AND RESULTS


In the present randomized controlled trial, a total of 2237 patients with stable CAD undergoing PCI were randomly chosen to be administered personalized antiplatelet therapy (personalized group; n = 1123) or standard antiplatelet treatment (standard group; n = 1114). The patients in the standard therapy group, without detecting the platelet aggregation rate, were administered a 75 mg/day clopidogrel maintenance dosage plus 100 mg/day of aspirin for at least 6 months after the procedure. For the patients in the personalized therapy group, the antiplatelet strategy was performed according to the maximum aggregation rate (MAR), determined using a novel platelet analyser, PL-12. If MAR > 55%, 90 mg ticagrelor was administered twice daily plus 100 mg/day of aspirin after PCI. If MAR ≤55%, 75 mg/day clopidogrel plus 100 mg/day of aspirin was administered after PCI. The primary endpoint was net clinical adverse events, which were a composite of cardiac death, myocardial infarction, stroke, stent thrombosis, urgent revascularization, and bleeding [Bleeding Academic Research Consortium (BARC) definitions, Type 2, 3, or 5], in the 180-day period after randomization. The primary endpoint was reached in 58 patients in the personalized group, compared with 85 patients in the standard group [5.1% vs. 7.5%, hazard ratio (HR) 0.678, 95% confidence interval (CI) 0.486-0.947, P = 0.023], on intention-to-treat analysis. We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR 0.510, 95% CI 0.284-0.915, P = 0.020). We did not find a significant difference in major bleeding events at either the 30-day (0.5% vs. 0.3%, P = 0.322) or the 180-day follow-up (2.1% vs. 1.6%, P = 0.364) between the two groups.
CONCLUSION


The present study suggests that personalized antiplatelet therapy according to MAR can significantly improve the net clinical benefit 180 days after PCI.",2020,"We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR: 0.510, 95% CI: 0.284-0.915, P = 0.020).","['stable coronary artery disease patients undergoing PCI', '2237 patients with stable coronary artery disease (CAD) undergoing PCI', 'stable CAD patients after PCI']","['ticagrelor', 'clopidogrel maintenance dosage plus 100\u2009mg/day of aspirin', 'personalized antiplatelet therapy (personalized group; n\u2009=\u20091123) or standard antiplatelet treatment', 'aspirin']","['net clinical adverse events, which were a composite of cardiac death, myocardial infarction (MI), stroke, stent thrombosis, urgent revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5', 'net clinical adverse events (including ischaemic and bleeding events', 'maximum aggregation rate (MAR', 'major bleeding events', 'platelet aggregation rate']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0430991', 'cui_str': 'Mixed antiglobulin test for sperm (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}]",2237.0,0.0964211,"We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR: 0.510, 95% CI: 0.284-0.915, P = 0.020).","[{'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xian-Geng', 'Initials': 'XG', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Cadre Ward, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi-Ning', 'Initials': 'YN', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi-Tong', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz059']
1293,31862436,Communicating health information and improving coordination with primary care (CHIIP): Rationale and design of a randomized cardiovascular health promotion trial for adult survivors of childhood cancer.,"BACKGROUND


Long-term survival for children diagnosed with cancer exceeds 80%. Notably, premature cardiovascular disease has become the leading non-cancer cause of late mortality among these survivors.
METHODS/DESIGN


This randomized controlled trial (RCT; NCT03104543) focuses on adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment. Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes. Those with abnormal values are then enrolled in an RCT to test the efficacy of a 12-month personalized, remotely delivered survivorship care plan (SCP) intervention designed to reduce undertreatment of these three target conditions. The intervention approximates a clinical encounter and is based on chronic disease self-management strategies.
RESULTS


With a goal of 750, currently 342 out of 742 eligible participants approached have enrolled (46.1%). Initially, we randomized participants to different recruitment strategies, including shorter approach packets and a tiered consent, but did not find significant differences in participation rates (40.7% to 42.9%; p = .95). Subsequently, slightly greater participation was seen with larger upfront unconditional incentive checks ($50 vs. $25: 50.7% vs. 44.1%; p = .10). Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive.
CONCLUSION


The overall study will determine if a National Academy of Medicine-recommended SCP intervention can improve cardiovascular outcomes among long-term survivors of childhood cancer. Modifications to the recruitment strategy may improve participation rates over time.",2020,"Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive.
","['Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes', 'adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment', '750, currently 342 out of 742 eligible participants approached have enrolled (46.1', 'children diagnosed with cancer exceeds 80', 'adult survivors of childhood cancer']","['survivorship care plan (SCP) intervention', 'primary care (CHIIP', 'Medicine-recommended SCP intervention']","['participation rates', 'cardiovascular outcomes']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0038955'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}]",[],742.0,0.163255,"Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive.
","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': ""Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA, United States of America. Electronic address: ericchow@uw.edu.""}, {'ForeName': 'Laura-Mae', 'Initials': 'LM', 'LastName': 'Baldwin', 'Affiliation': 'Department of Family Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Hagen', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States of America; Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Gibson', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Kochar', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Nathan', 'Affiliation': 'Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Tonorezos', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yasui', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Armstrong', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Oeffinger', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105915']
1294,31851011,Effects of Home Exercises on Shoulder Pain and Pathology in Chronic Spinal Cord Injury: A Randomized Controlled Trial.,"OBJECTIVE


The aims of this study were to replicate findings that a home exercise program intervention improved shoulder pain and function and to assess changes in supraspinatus tendon pathology associated with the home exercise program in persons with chronic spinal cord injury.
DESIGN


The study is a single-blind randomized controlled trial. Individuals with spinal cord injury of at least 1 yr and chronic shoulder pain of moderate or greater average intensity were enrolled. Participants were randomized to a 12-wk home exercise program consisting of strengthening and stretching exercises or to an education-only control group, with immediate postintervention and 4-wk postintervention (16 wks) follow-ups. The main outcome measures were self-report measures of shoulder pain and impairment, the Physical Examination of the Shoulder Scale, quantitative ultrasound metrics of the supraspinatus tendon, and the Ultrasound Shoulder Pathology Rating Scale.
RESULTS


Thirty-two participants were randomized to home exercise program or education-only control condition. The mean ± SD age was 44.8 ± 12.5; 81.3% were male; 65.6% had motor complete paraplegia. Using a per-protocol, within-group analysis method, significant differences were observed between baseline and postintervention for the home exercise program group for the least pain intensity (P = 0.02), number of days with shoulder pain (P = 0.042), Physical Examination of the Shoulder Scale scores (dominant side, P = 0.036; nondominant side, P = 0.008), the Disabilities of the Arm, Shoulder, and Hand (P = 0.028), and the Patient Global Impression of Change (P = 0.015). The education-only control condition group demonstrated significant changes in average unpleasantness of shoulder pain after the intervention period (P = 0.049). Comparisons in changes from baseline between groups showed that the home exercise program group had greater improvements in nondominant-side Physical Examination of the Shoulder Scale scores and global impression of change, whereas the education-only control condition group had greater improvements in depressive symptoms.For quantitative ultrasound measures, no significant changes were found with within-group analyses for the home exercise program group, although the education-only control condition group demonstrated a decrease in tendon width in the nondominant-side supraspinatus tendon (P = 0.036). Comparison of changes between groups suggests that the education-only control condition group had a greater increase in dominant shoulder supraspinatus tendon ultrasound contrast at the end of the study.
CONCLUSIONS


Changes in several measures of shoulder pain and function occurred after the home exercise program intervention, although the magnitude of changes was only significantly greater than those of the education-only control condition group for two measures. Significant changes in supraspinatus pathology were not detected with quantitative ultrasound metrics.",2020,"Participants were randomized to a 12-week HEP consisting of strengthening and stretching exercises or to an education-only control group (CON), with immediate post-intervention and 4-week post-intervention (16 weeks) follow-ups.","['Individuals with SCI of at least 1 year and chronic shoulder pain of moderate or greater average intensity were enrolled', 'Chronic Spinal Cord Injury', '32 participants', 'Average age was 44.8 ', 'persons with chronic spinal cord injury (SCI']","['home exercise program (HEP) intervention', 'HEP consisting of strengthening and stretching exercises or to an education-only control group (CON), with immediate post-intervention and 4-week post-intervention', 'CON', 'Home Exercises', 'HEP or CON', 'HEP']","['tendon width', 'Patient Global Impression of Change', 'least pain intensity', 'self-report measures of shoulder pain and impairment, and the Physical Examination of the Shoulder Scale (PESS), quantitative ultrasound (QUS) metrics of the supraspinatus tendon, and the Ultrasound Shoulder Pathology Rating Scale (USPRS', 'depressive symptoms', 'supraspinatus pathology', 'motor complete paraplegia', 'PESS scores', 'shoulder pain and function', 'average unpleasantness of shoulder pain', 'Shoulder Pain and Pathology', 'number of days with shoulder pain', 'non-dominant side PESS scores and global impression of change']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0222045'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1659098', 'cui_str': 'Complete paraplegia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445549', 'cui_str': 'Non-dominant side (qualifier value)'}]",32.0,0.0837195,"Participants were randomized to a 12-week HEP consisting of strengthening and stretching exercises or to an education-only control group (CON), with immediate post-intervention and 4-week post-intervention (16 weeks) follow-ups.","[{'ForeName': 'Diana D', 'Initials': 'DD', 'LastName': 'Cardenas', 'Affiliation': 'From the South Florida SCI Model System, Department of Physical Medicine & Rehabilitation, University of Miami Miller School of Medicine, Miami, Florida (DDC, ERF, RI); Miami Veterans Administration Medical Center, Miami, Florida (ERF); Department of Physical Medicine & Rehabilitation, University of Alabama at Birmingham, Birmingham, Alabama (RC); and Jackson Memorial Hospital, Miami, Florida (MFO).'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Felix', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cowan', 'Affiliation': ''}, {'ForeName': 'Melanie F', 'Initials': 'MF', 'LastName': 'Orell', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Irwin', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001362']
1295,30879734,Effect of late versus early initiation of parenteral nutrition on weight deterioration during PICU stay: Secondary analysis of the PEPaNIC randomised controlled trial.,"BACKGROUND & AIMS


Critically ill children are at increased risk of weight deterioration in the paediatric intensive care unit (PICU). Whether early initiation of parenteral nutrition (PN) prevents weight deterioration is unknown. The aims of this study were to assess the effect of withholding supplemental PN during the first week on weight Z-score change in PICU and to evaluate the association between weight Z-score change in the PICU and clinical outcomes.
METHODS


This is a secondary analysis of the Paediatric Early versus Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC) randomised controlled trial (N = 1440), which focused on the subgroup of patients with longitudinal weight Z-scores available on admission and on the last day in PICU. Patients were randomly allocated to initiation of supplemental PN after one week (Late-PN) or within 24 h (Early-PN) when enteral nutrition was insufficient. The effect of Late-PN versus Early-PN on the change in weight Z-score was investigated, adjusted for risk factors. Moreover, the association between weight Z-score change and clinical outcomes was explored, adjusted for risk factors.
RESULTS


Longitudinal weight Z-scores were available for 470 patients. Enteral nutrition intake was equal in the Early-PN and Late-PN group. Less weight Z-score deterioration during PICU stay was associated with a lower risk of new infections (adjusted OR per Z-score increase 0.72 [0.55-0.96], p = 0.02), and with a higher likelihood of an earlier discharge from PICU alive (adjusted HR per Z-score increase 1.22 [1.10-1.37], p < 0.001). During PICU-stay, the change in weight Z-score did not differ among both groups (Late-PN median 0.00 [-0.34-0.12] vs Early-PN median -0.03 [-0.48-0.01], adjusted β = 0.10 [-0.05-0.25], p = 0.18).
CONCLUSIONS


Weight deterioration during the PICU stay was associated with worse clinical outcomes. Withholding supplemental PN during the first week did not aggravate weight Z-score deterioration during PICU stay.
TRIAL REGISTRATION


clinicaltrials.gov NCT01536275.",2020,"During PICU-stay, the change in weight Z-score did not differ among both groups (Late-PN median 0.00 [-0.34-0.12] vs Early-PN median ","['470 patients', 'patients with longitudinal weight Z-scores available on admission and on the last day in PICU']","['parenteral nutrition', 'Late-PN versus Early-PN', 'parenteral nutrition (PN']","['weight Z-score change and clinical outcomes', 'weight Z-score', 'Enteral nutrition intake', 'weight deterioration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0457453', 'cui_str': 'On admission (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]",,0.217242,"During PICU-stay, the change in weight Z-score did not differ among both groups (Late-PN median 0.00 [-0.34-0.12] vs Early-PN median ","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'van Puffelen', 'Affiliation': ""Department of Paediatrics and Paediatric Surgery, Intensive Care Unit, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.""}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hulst', 'Affiliation': ""Department of Paediatrics, Division of Paediatric Gastroenterology, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dulfer', 'Affiliation': ""Department of Paediatrics and Paediatric Surgery, Intensive Care Unit, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'K F M', 'Initials': 'KFM', 'LastName': 'Joosten', 'Affiliation': ""Department of Paediatrics and Paediatric Surgery, Intensive Care Unit, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.""}, {'ForeName': 'S C A T', 'Initials': 'SCAT', 'LastName': 'Verbruggen', 'Affiliation': ""Department of Paediatrics and Paediatric Surgery, Intensive Care Unit, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands. Electronic address: s.verbruggen@erasmusmc.nl.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.014']
1296,31601716,Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.,"BACKGROUND AND AIM


Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity  via  genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS  via  a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.
METHODS


This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea-hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604.
RESULTS


22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m -2 ) completed the protocol. At 6 months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1 events·h -1 , a mean change of 10.8 events·h -1  (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h -1 , a mean change of 9.3 events·h -1  (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.
CONCLUSIONS


Bilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.",2020,"Daytime sleepiness (ESS, p=0.01) and sleep-related quality of life (FOSQ-10, p=0.02) both significantly improved.","['27 implanted participants (63% male', 'aged 55.9±12.0\u2005years, BMI 27.4±3.0\u2005kg·m -2 ), 22 completed the protocol', 'eight centres in three countries (Australia, France, UK', 'Adult Obstructive Sleep Apnea']","['Bilateral Hypoglossal Nerve Stimulation', 'Hypoglossal Nerve Stimulation (HNS']","['safety and effectiveness', 'number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring', 'Obstructive Sleep Apnea (OSA', 'Daytime sleepiness (ESS, p=0.01) and sleep-related quality of life', 'change in the 4% Oxygen Desaturation Index (ODI', 'OSA severity and improve quality of life', 'measures of sleepiness, quality of life, snoring, and device use', 'SAE', 'ODI', 'incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI', 'AHI']","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0020614', 'cui_str': 'Cranial Nerve XII'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0557652', 'cui_str': 'Bedroom (environment)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]",22.0,0.0898181,"Daytime sleepiness (ESS, p=0.01) and sleep-related quality of life (FOSQ-10, p=0.02) both significantly improved.","[{'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Eastwood', 'Affiliation': 'Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Australia peter.eastwood@health.wa.gov.au.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Barnes', 'Affiliation': 'Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'MacKay', 'Affiliation': 'Illawarra ENT Head and Neck Clinic, Wollongong, Australia.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wheatley', 'Affiliation': 'Dept of Respiratory and Sleep Medicine, Westmead Hospital, Westmead, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hillman', 'Affiliation': 'Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Xuân-Lan', 'Initials': 'XL', 'LastName': 'Nguyên', 'Affiliation': 'Unité de Somnologie et Fonction Respiratoire, Hopital St Antoine, Paris, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Dept Otolaryngology, Head and Neck Surgery, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Campbell', 'Affiliation': 'Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Pételle', 'Affiliation': 'Service ORL Chirurgie de la Face et du Cou, Hôpital Tenon, AP-HP, Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Walsh', 'Affiliation': 'Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Jones', 'Affiliation': 'Illawarra ENT Head and Neck Clinic, Wollongong, Australia.'}, {'ForeName': 'Carsten E', 'Initials': 'CE', 'LastName': 'Palme', 'Affiliation': 'University of Sydney at Westmead Hospital, Westmead, Australia.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bizon', 'Affiliation': 'Dept Otolaryngology, Head and Neck Surgery, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Meslier', 'Affiliation': 'Dept of Respiratory and Sleep Medicine, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Bertolus', 'Affiliation': 'AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service des Pathologies du Sommeil (Département ""R3S""), Paris, France.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Maddison', 'Affiliation': 'Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Laccourreye', 'Affiliation': 'Dept Otolaryngology, Head and Neck Surgery, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Raux', 'Affiliation': 'Nyxoah, S.A., Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Denoncin', 'Affiliation': 'Nyxoah, S.A., Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Attali', 'Affiliation': 'Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Gagnadoux', 'Affiliation': 'Dept of Respiratory and Sleep Medicine, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Sandrine H', 'Initials': 'SH', 'LastName': 'Launois', 'Affiliation': 'Unité de Somnologie et Fonction Respiratoire, Hopital St Antoine, Paris, France.'}]",The European respiratory journal,['10.1183/13993003.01320-2019']
1297,32492153,VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population.,"CONTEXT


It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting.
OBJECTIVE


The objective of this work is to determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.
DESIGN


VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25 871 adults, randomly assigned November 2011 to March 2014 and treated for 5.3 years (median).
SETTING


This is a nationwide study.
PARTICIPANTS


Men 50 years or older and women 55 years or older (mean age, 67.1 years) without cancer or cardiovascular disease at baseline participated in this study.
INTERVENTIONS


Interventions included vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2 × 2 factorial design.
MAIN OUTCOME MEASURES


Main outcome measures include 2 or more falls and falls resulting in a doctor or hospital visit.
RESULTS


Baseline serum total 25-hydroxyvitamin D (25[OH]D) level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with 2 or more falls were similar between active and placebo groups (9.8% vs 9.4%). Over 5 years, there were no differences in the proportion having 2 or more falls (odds ratio [OR] = 0.97; 95% CI, 0.90-1.05, P = .50), falls resulting in a doctor visit (OR = 1.03; 95% CI, 0.94-1.13, P = .46), or resulting in a hospital visit (OR = 1.04; 95% CI, 0.90-1.19, P = .61) between groups. Results did not differ between those with baseline 25(OH)D less than 50 vs 50 nmol/L or greater or other cut points.
CONCLUSION


Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.",2020,Results did not differ between those with baseline 25(OH)D,"['Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline', 'Nationwide study', '25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median', 'generally healthy adults']","['vitamin D3 vs. placebo', 'supplemental vitamin D3', 'VITamin D and OmegA-3 TriaL (VITAL', 'placebo-controlled RCT', 'VITamin D and OmegA-3 TriaL', 'Vitamin D3 (cholecalciferol; 2,000 IU/day', 'Vitamin D Supplements', 'and/or omega-3 fatty acids (1 g/day) or respective placebos', 'vitamin D supplementation', 'placebo']","['proportion having ≥2 falls', 'falls resulting in a doctor visit', 'Risk of Falls', 'Baseline serum total 25-hydroxyvitamin D [25(OH)D] level', 'fall risk', 'falls, falls resulting in a doctor or hospital visit']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",25871.0,0.702356,Results did not differ between those with baseline 25(OH)D,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Cawthon', 'Affiliation': 'California Pacific Medical Center, Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa311']
1298,30125462,Early conversion of pediatric kidney transplant patients to everolimus with reduced tacrolimus and steroid elimination: Results of a randomized trial.,"In a 12-month, multicenter, open-label study, 106 children were randomized at 4 to 6 weeks after kidney transplantation to switch to everolimus with reduced TAC (EVR/rTAC) and steroid elimination from month 5 posttransplant or to continue standard tacrolimus with mycophenolate mofetil (sTAC/MMF) and steroids. The cumulative incidence of a co-primary efficacy end point (biopsy-proven acute rejection [BPAR], graft loss, or death from randomization to month 12) was 10.3% with EVR/rTAC and 5.8% with sTAC/MMF (difference 4.4%; P = .417). BPAR occurred in 9.6% and 5.6% of patients, respectively. Patient and renal allograft survival were 100%. The co-primary end point of mean estimated glomerular filtration rate at month 12 was 76.2 mL/min/1.73 m 2  with EVR/rTAC and 72.5 mL/min/1.73 m 2  for sTAC/MMF (difference 3.8 mL/min/1.73m 2  ; P = .49). One EVR/rTAC patient developed posttransplant lymphoproliferative disease. Longitudinal growth and sexual maturation were equivalent between groups. The randomized drug regimen was discontinued in 34.6% and 13% of patients in the EVR/rTAC and sTAC/MMF groups, respectively (P = .024), and discontinued due to adverse events/infections in 25.0% and 11.1% of patients (P = .062). In conclusion, early conversion of pediatric kidney transplant patients from TAC, MMF, and steroids to EVR/rTAC and steroid withdrawal maintains immunosuppressive efficacy and preserves renal function.",2019,Longitudinal growth and sexual maturation were equivalent between groups.,"['106 children', 'pediatric kidney transplant patients to everolimus with reduced tacrolimus and steroid elimination']","['kidney transplantation to switch to everolimus with reduced TAC (EVR/rTAC) and steroid elimination from month 5 posttransplant or to continue standard tacrolimus with mycophenolate mofetil (sTAC/MMF) and steroids', 'sTAC/MMF']","['cumulative incidence of a co-primary efficacy end point (biopsy-proven acute rejection [BPAR], graft loss, or death', 'posttransplant lymphoproliferative disease', 'renal allograft survival', 'glomerular filtration rate', 'adverse events/infections', 'BPAR', 'Longitudinal growth and sexual maturation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024314', 'cui_str': 'Lymphoproliferative Disorders'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0036887', 'cui_str': 'Sexual Maturation'}]",106.0,0.0244982,Longitudinal growth and sexual maturation were equivalent between groups.,"[{'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ettenger', 'Affiliation': ""Division of Pediatric Nephrology, UCLA Mattel Children's Hospital, Los Angeles, CA, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dello Strologo', 'Affiliation': ""Nephrology Unit, Department of Pediatrics, Institute for Scientific Research, Bambino Gesù Children's Hospital, Rome, Italy.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Marks', 'Affiliation': 'Department of Paediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva', 'Affiliation': 'Nephrology Division, Hospital do Rim, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjerre', 'Affiliation': 'Division of Paediatric and Adolescent Medicine, Department of Pediatrics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': ""Department of Paediatric Nephrology, Nottingham Children's Hospital, Nottingham, UK.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'El-Djouher', 'Initials': 'ED', 'LastName': 'Martzloff', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rauer', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ng', 'Affiliation': 'Biometrics and Statistical Science, Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15081']
1299,31846857,Refining hand washing interventions by identifying active ingredients: A cluster-randomized controlled trial in rural Zimbabwe.,"RATIONALE


Consistent hand washing with soap can reduce the risk of diarrhea, but changing hand-washing behavior is difficult. Systematic behavior change approaches promise to enhance hand washing with soap effectively, and allow the identification of active intervention ingredients using mediation analysis. This knowledge can then be used to derive hypotheses for systematically refining the intervention.
OBJECTIVE


We demonstrate this at the example of a behavior change intervention to promote hand washing with soap based on the RANAS approach (risk, attitudes, norms, ability, and self-regulation).
METHODS


Sixteen wards of Masvingo province in Zimbabwe were randomly allocated to the RANAS-based intervention or a wait-list control group. Hand washing at baseline and follow-up was observed for 224 randomly selected caregivers of young children. They additionally participated in quantitative face-to-face interviews assessing psychosocial factors.
RESULTS


At baseline, hand washing with soap was <3% on average, and did not differ between groups (p = .526). At follow-up, intervention participants washed hands with soap more frequently than controls (in 29.4% vs. 8.2% of all stool- and food-related situations, B = 1.88, SE = 0.32, OR = 6.6, p < .001). Mediation analyses revealed that the intervention enhanced several of the targeted psychosocial factors; return, descriptive and injunctive norms, action knowledge, action self-efficacy, maintenance self-efficacy, action planning, and remembering. The intervention effect was mediated through increased remembering.
CONCLUSION


This study supports the efficacy of a systematic approach to behavior change to promote hand washing with soap. The analyses of the mechanisms revealed important insights into the active ingredients of the intervention, which will facilitate its future refinement.",2020,"At baseline, hand washing with soap was <3% on average, and did not differ between groups (p = .526).","['224 randomly selected caregivers of young children', 'Sixteen wards of Masvingo province in Zimbabwe', 'rural Zimbabwe']","['RANAS-based intervention or a wait-list control group', 'Refining hand washing interventions']","['risk of diarrhea', 'targeted psychosocial factors; return, descriptive and injunctive norms, action knowledge, action self-efficacy, maintenance self-efficacy, action planning, and remembering']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",224.0,0.0242939,"At baseline, hand washing with soap was <3% on average, and did not differ between groups (p = .526).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Inauen', 'Affiliation': 'Institute of Psychology, University of Bern, Bern, Switzerland; Department of Environmental Social Sciences, Eawag: Swiss Federal Institute of Aquatic Science & Technology, Duebendorf, Switzerland. Electronic address: jennifer.inauen@psy.unibe.ch.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lilje', 'Affiliation': 'Department of Environmental Social Sciences, Eawag: Swiss Federal Institute of Aquatic Science & Technology, Duebendorf, Switzerland.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Mosler', 'Affiliation': 'Department of Environmental Social Sciences, Eawag: Swiss Federal Institute of Aquatic Science & Technology, Duebendorf, Switzerland.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.112712']
1300,30125457,Effects of marine n-3 fatty acid supplementation in renal transplantation: A randomized controlled trial.,"Marine n-3 fatty acids (FAs) may exert beneficial effects on inflammation, fibrosis, and endothelial function, which could preserve renal graft function. In this randomized controlled trial, 132 Norwegian renal transplant recipients received either 2.6 g of marine n-3 FAs or olive oil (control) daily for 44 weeks, in addition to standard care. Thirty patients did not complete the trial. The primary endpoint was change (Δ) in measured glomerular filtration rate (mGFR) during follow-up. We found no significant difference in Δ mGFR between the marine n-3 FA group and controls (6.7 vs 3.8 mL/min per 1.73 m 2  , P = .15). Significant beneficial effects from marine n-3 FA supplementation were, however, seen in secondary endpoints plasma triglycerides, plasma high-sensitivity C-reactive protein, and brachial artery flow-mediated dilation. In the per-protocol population, the renal graft indices percent interstitial fibrosis and Chronic Allograft Damage Index also were significantly lower in the marine n-3 FA group. The cumulative incidence of adverse events did not differ between the marine n-3 FA group (n = 218) and controls (n = 240). In conclusion, marine FA supplementation did not improve renal function compared with controls, but was safe, lowered plasma triglyceride and high-sensitivity C-reactive protein levels, and improved endothelial function (Clinical.Trials.gov identifier NCT01744067).",2019,"In the per-protocol population, the renal graft indices percent interstitial fibrosis and Chronic Allograft Damage Index also were significantly lower in the marine n-3 FA group.","['renal transplantation', 'Thirty patients did not complete the trial', '132 Norwegian renal transplant recipients']","['marine n-3 FA', 'marine n-3 fatty acid supplementation', '2.6\xa0g of marine n-3 FAs or olive oil (control', 'marine FA supplementation', 'marine n-3 FA supplementation', 'Marine n-3 fatty acids (FAs']","['renal function', 'renal graft indices percent interstitial fibrosis and Chronic Allograft Damage Index', 'safe, lowered plasma triglyceride and high-sensitivity C-reactive protein levels, and improved endothelial function', 'cumulative incidence of adverse events', 'glomerular filtration rate (mGFR', 'plasma triglycerides, plasma high-sensitivity C-reactive protein, and brachial artery flow-mediated dilation']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}]","[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C3887486', 'cui_str': 'Interstitial fibrosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",132.0,0.10126,"In the per-protocol population, the renal graft indices percent interstitial fibrosis and Chronic Allograft Damage Index also were significantly lower in the marine n-3 FA group.","[{'ForeName': 'Ivar A', 'Initials': 'IA', 'LastName': 'Eide', 'Affiliation': 'Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Finn P', 'Initials': 'FP', 'LastName': 'Reinholt', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Jenssen', 'Affiliation': 'Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Åsberg', 'Affiliation': 'Department of Renal Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Bergan', 'Affiliation': 'Department of Pharmacology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Brabrand', 'Affiliation': 'Department of Radiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'My', 'Initials': 'M', 'LastName': 'Svensson', 'Affiliation': 'Department of Renal Medicine, Akershus University Hospital, Lørenskog, Norway.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15080']
1301,31586206,13-valent Pneumococcal Conjugate Vaccine in children with acute lymphoblastic leukaemia: protective immunity can be achieved on completion of treatment.,"BACKGROUND


Children with acute lymphoblastic leukaemia (ALL) are at increased risk of invasive pneumococcal disease. This study describes the immunogenicity of 13-valent pneumococcal conjugate vaccine (PCV13) during and after chemotherapy.
METHODS


Children with ALL were allocated to study groups and received a single dose of PCV13: Group 1 - maintenance chemotherapy; Group 2 - end of chemotherapy; Group 3 - 6 months after chemotherapy. A protective vaccine response was defined as at least 10 of 12 serotypes (or greater than 83% of serotypes with data) achieving post-vaccination serotype-specific IgG ≥ 0.35 µg/mL and ≥ 4 fold rise, compared to pre-vaccination at 1 and 12 months.
RESULTS


One hundred and eighteen children were recruited. Only 12.8% (5/39; 95% CI 4.3% to 27.4%) of patients vaccinated during maintenance (Group 1) achieved a protective response at 1 month post-vaccination and none had a protective response at 12 months. For Group 2 patients, 59.5% (22/37; 95% CI 42.1% to 75.3%) achieved a response at 1 month and 37.9% (11/29; 95% CI 20.7% to 57.7%) maintained immunity at 12 months. For Group 3 patients, 56.8% (21/37; 95% CI 39.5% to 72.9%) achieved a protective response at 1 month and 43.3% (13/30; 95% CI 25.5% to 62.6%) maintained immunity at 12 months.
CONCLUSION


This study demonstrated the earliest time point at which protective immunity can be achieved in children with ALL is on completion of chemotherapy. This is earlier than current recommendations and may improve protection during a period when children are most susceptible to infection.",2019,"For Group 2 patients, 59.5% (22/37; 95% CI 42.1% to 75.3%) achieved a response at 1 month and 37.9% (11/29; 95% CI 20.7% to 57.7%) maintained immunity at 12 months.","['Children with ALL', 'Children with acute lymphoblastic leukaemia (ALL', 'children with ALL', 'children with acute lymphoblastic leukaemia', 'One hundred and eighteen children were recruited']","['PCV13: Group 1 - maintenance chemotherapy; Group 2 - end of chemotherapy', '13-valent pneumococcal conjugate vaccine (PCV13', 'Pneumococcal Conjugate Vaccine']","['protective vaccine response', 'protective response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia, disease (disorder)'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]",118.0,0.104254,"For Group 2 patients, 59.5% (22/37; 95% CI 42.1% to 75.3%) achieved a response at 1 month and 37.9% (11/29; 95% CI 20.7% to 57.7%) maintained immunity at 12 months.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bate', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Manchester.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chisholm', 'Affiliation': 'Department of Paediatric Oncology, Royal Marsden Hospital, Sutton, Surrey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dixon', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Galanopoulou', 'Affiliation': 'University of Southampton, Clinical Trials Unit, Southampton.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Great Ormond Street Institute of Child Health Biomedical Research Centre, University College London, London.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': 'Great Ormond Street Institute of Child Health Biomedical Research Centre, University College London, London.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'University of Southampton, Clinical Trials Unit, Southampton.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mapstone', 'Affiliation': 'University of Southampton, Clinical Trials Unit, Southampton.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': ""Paediatric Infectious Diseases Research Group & Vaccine Institute, St. George's University of London and St Georges University Hospitals NHS Trust, London, England.""}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Williams', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Gray', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Manchester.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz965']
1302,31583977,Randomized Pilot Study: A Mobile Technology-based Self-management Intervention for Sickle Cell Pain.,"Little is known about the effects of self-managed relaxation interventions on pain, stress, and autonomic responses in patients with sickle cell disease (SCD). This pre-post randomized controlled pilot study was conducted to determine the feasibility of using computer tablets for relaxation intervention delivery; acceptability of study procedures; and intervention effects on pain, stress, and indicators of relaxation. The 30 research participants ranged in age from 22 years to 59 years. All were African American; 53% were male. They were randomized to an experimental group that watched a relaxation video or a control group that discussed their disease. All participants completed the study, indicating feasibility. Acceptability rates were also high. Data were obtained for the intervention's immediate effect on pain, stress, respiration, pulse, finger skin temperature, and self-reported relaxation. These preliminary findings will guide future, higher-powered studies to determine the intervention's efficacy and mechanism in SCD.The ClinicalTrials.gov Identifier: NCT02729363.",2020,Acceptability rates were also high.,"['30 research participants ranged in age from 22 years to 59 years', 'Sickle Cell Pain', 'patients with sickle cell disease (SCD', 'All were African American; 53% were male']","['relaxation video', 'Mobile Technology-based Self-management Intervention', 'self-managed relaxation interventions']","['Acceptability rates', 'pain, stress, respiration, pulse, finger skin temperature, and self-reported relaxation', 'pain, stress, and autonomic responses', 'pain, stress, and indicators of relaxation']","[{'cui': 'C0035168'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte (cell)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0398662,Acceptability rates were also high.,"[{'ForeName': 'Miriam O', 'Initials': 'MO', 'LastName': 'Ezenwa', 'Affiliation': 'Department of Biobehavioral Nursing Science, College Of Nursing, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Biobehavioral Nursing Science, College Of Nursing, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Minh-Nguyet T', 'Initials': 'MT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Molly W', 'Initials': 'MW', 'LastName': 'Mandernach', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Clayton T', 'Initials': 'CT', 'LastName': 'Hunter', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Saunjoo L', 'Initials': 'SL', 'LastName': 'Yoon', 'Affiliation': 'Department of Biobehavioral Nursing Science, College Of Nursing, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fedele', 'Affiliation': 'Department of Clinical & Health Psychology, Gainesville, Florida, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lucero', 'Affiliation': 'Department of Family, Community, and Health System Science, College Of Nursing, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Lyon', 'Affiliation': 'Department of Biobehavioral Nursing Science, College Of Nursing, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'Department of Biobehavioral Nursing Science, College Of Nursing, University of Florida, Gainesville, Florida, USA.'}]",Western journal of nursing research,['10.1177/0193945919878821']
1303,28332858,Modified Cognitive Behavioral Therapy for Insomnia in Depressed Adolescents: A Pilot Study.,"Objective/Background:  The purpose of the study was to pilot a five-week insomnia treatment in adolescents with major depressive disorder (MDD) and insomnia. This was an open-label trial of a modified-group cognitive behavioral therapy for insomnia (CBTI).  Participants:  Adolescents with MDD ( n  = 16; mean age = 17.3 +/- 1.7), characterized by the Children's Depression Rating Scale-Revised T-score ≥ 55 and insomnia, characterized by > 30 min to fall or return to sleep and an Insomnia Severity Index (ISI) score of ≥ 7 participated.  Methods:  Sleep diaries, actigraphy, weekly ISI, Quick Inventory of Depressive Symptomatology (QIDS), and Multidimensional Fatigue Inventory (MFI) were completed.  Results:  Paired  t -tests comparing pre- and posttreatment revealed a decrease in sleep onset latency from 41 min +/- 14 min to 18 min +/- 8.9 min ( t  = 5.9,  p  = .004). Linear mixed modeling across sessions revealed that ISI ( B  = 11.0,  SE  = 0.94,  p  < .001), QIDS ( B  = 11.3,  SE  = 0.96,  p  < .001), and MFI ( B  = 30.0,  SE  = 4.4,  p  < .001) improved across treatment. Daily sleep diaries showed decreased wake during the night ( B  = 22.8,  SE  = 7.19,  p  = .008), increased sleep time ( B  = 382.4,  SE  = 71.89,  p  < .001), and increased quality of sleep ( B  = 3.7,  SE  = 0.37,  p  < .001). When asked whether group members would recommend this group, 27% responded ""yes"" and 73% responded ""definitely yes.""  Conclusions:  Additional controlled studies utilizing sleep-focused therapy in depressed adolescents with insomnia are warranted.",2019,"Daily sleep diaries showed decreased wake during the night (B = 22.8, SE = 7.19, p = .008), increased sleep time (B = 382.4, SE = 71.89, p < .001), and increased quality of sleep (B = 3.7, SE = 0.37, p < .001).","['adolescents with major depressive disorder (MDD) and insomnia', 'Adolescents with MDD (n = 16; mean age = 17.3 ', 'insomnia (CBTI', 'depressed adolescents with insomnia', 'Depressed Adolescents']","['Modified Cognitive Behavioral Therapy', 'modified-group cognitive behavioral therapy', 'yes"" and 73% responded ""definitely yes']","['Daily sleep diaries', 'sleep onset latency', ""Children's Depression Rating Scale-Revised T-score ≥ 55 and insomnia, characterized by > 30 min to fall or return to sleep and an Insomnia Severity Index (ISI) score"", 'increased sleep time', 'QIDS', 'MFI', 'Sleep diaries, actigraphy, weekly ISI, Quick Inventory of Depressive Symptomatology (QIDS), and Multidimensional Fatigue Inventory (MFI', 'quality of sleep']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C4706228', 'cui_str': 'Insomnia Severity Index score (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}]",,0.0345799,"Daily sleep diaries showed decreased wake during the night (B = 22.8, SE = 7.19, p = .008), increased sleep time (B = 382.4, SE = 71.89, p < .001), and increased quality of sleep (B = 3.7, SE = 0.37, p < .001).","[{'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Conroy', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Czopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Dore-Stites', 'Affiliation': 'Pediatric Behavioral Development, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Dopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Roseanne', 'Initials': 'R', 'LastName': 'Armitage', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Hoban', 'Affiliation': 'Pediatric Sleep Medicine and Clinical Neurophysiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}]",Behavioral sleep medicine,['10.1080/15402002.2017.1299737']
1304,31577792,Text messaging for maternal and infant retention in prevention of mother-to-child HIV transmission services: A pragmatic stepped-wedge cluster-randomized trial in Kenya.,"BACKGROUND


Timely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention.
METHODS AND FINDINGS


In a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range [IQR] 23-30), median gestational age was 30 weeks (IQR 28-34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk [aRR] 1.03; 95% CI 0.97-1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97-1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention.
CONCLUSIONS


In this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates.
TRIAL REGISTRATION


ClinicalTrials.gov Trial Number NCT02350140.",2019,There was also a nonsignificant increase in maternal postpartum retention in the intervention periods.,"['2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery ', 'Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included', 'Overall median age was 27 years (interquartile range [IQR] 23-30), median gestational age was 30 weeks (IQR 28-34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone']",['Texting Improves Testing (TextIT) intervention (a theory-based text messaging system'],"['infant HIV testing and maternal retention in care during the first 8 weeks after delivery', 'HIV virologic testing', 'maternal postpartum retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4704685', 'cui_str': 'Retention in Care'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704685', 'cui_str': 'Retention in Care'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",2472.0,0.203468,There was also a nonsignificant increase in maternal postpartum retention in the intervention periods.,"[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Odeny', 'Affiliation': 'Department of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, United States of America.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Eliud', 'Initials': 'E', 'LastName': 'Akama', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Elvin H', 'Initials': 'EH', 'LastName': 'Geng', 'Affiliation': 'University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'King K', 'Initials': 'KK', 'LastName': 'Holmes', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'McClelland', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1002924']
1305,31588804,Glycemic impact of a diet and lifestyle intervention on diabetics and prediabetics during treatment for non-muscle invasive bladder cancer.,"Introduction:  Patients with Type II Diabetes Mellitus (DM2) have increased risk of recurrence and progression of non-muscle invasive bladder cancer (NMIBC). Glucose control through lifestyle intervention is an uninvestigated, attractive strategy to decrease risk of cancer recurrence. We test the feasibility of a diet and exercise program and its glycemic impact in patients with DM2 and NMIBC. Materials/methods:  Five participants with NMIBC and pre-diabetes or DM2 were recruited for a pilot, prospective clinical trial. Each participant received dietary counseling for 16 sessions during clinical visits. The intervention included a carbohydrate-restricted (CR) diet (<130 grams per day), 30 min, walking 5×/wk, and 5000 steps daily. Diet compliance was measured with 24-hour diet recall. Exercise was monitored with accelerometer and self-report. Results:  Five participants enrolled and two participants completed the 12-month intervention. Adherence was 60% to CR diet and 84% to exercise goals. Participants reduced carbohydrate consumption by 44%. Participants showed reductions in fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring. Conclusions:  Adherence to a CR diet and exercise goals is feasible in patients with NMIBC and DM2 and also leads improved glucose control. A phase-II trial on bladder cancer-specific outcomes is warranted.",2020,"Participants showed reductions in fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring.  ","['patients with DM2 and NMIBC', 'Five participants with NMIBC and pre-diabetes or DM2', 'non-muscle invasive bladder cancer', 'patients with NMIBC and DM2', 'Patients with Type II Diabetes', 'Five participants enrolled and two participants completed the 12-month intervention']","['Glucose control through lifestyle intervention', 'diet and exercise program', 'dietary counseling', 'diet and lifestyle intervention', 'carbohydrate-restricted (CR) diet']","['risk of cancer recurrence', 'carbohydrate consumption', 'fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring', 'Adherence', 'diabetics and prediabetics', 'Diet compliance', 'risk of recurrence and progression of non-muscle invasive bladder cancer (NMIBC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]",5.0,0.025133,"Participants showed reductions in fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring.  ","[{'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Chestnut', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Woodson', 'Initials': 'W', 'LastName': 'Smelser', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Dum', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Misty', 'Initials': 'M', 'LastName': 'Bechtel', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hand', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Michel', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'Bawajeeh', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Zohreh', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Weiya', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Anant', 'Affiliation': 'Department of Cancer Biology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robbins', 'Affiliation': 'Department of Internal Medicine, Diabetes Institute, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Holzbeierlein', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hamilton-Reeves', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Eugene K', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}]",Nutrition and cancer,['10.1080/01635581.2019.1672761']
1306,31576471,Psychoeducational group intervention for breast cancer survivors: a non-randomized multi-center pilot study.,"PURPOSE


The aim of the study was to evaluate an outpatient psychoeducational group program for breast cancer patients aimed to improve various psychosocial parameters, enhancing the patients' competence and reducing fear of recurrence.
METHODS


The study is based on a multi-center, non-randomized control group design with three measurement time points (T1 baseline, T2 end of the intervention, T3 6-week follow-up). Breast cancer patients were assessed with various standardized questionnaires including fear of progression, self-efficacy, depression, and quality of life.
RESULTS


A total of 50 breast cancer patients participated (intervention group n = 27, control group n = 23). The results show a significant reduction in the fear of progression/recurrence (FoPR) (p = 0.003) and a significant increase in self-efficacy (SE) (p = 0.007) for the intervention group with a large (FoPR, Eta 2  = .178) and medium (SE, Eta 2  = .113) effect size, respectively. For all other outcome criteria such as depressive symptoms, social support, or quality of life, no significant changes over time or differences between both groups were found.
CONCLUSIONS


The psychoeducational program has been proven to be effective for breast cancer survivors, but further investigation based on a randomized trial is necessary.
PRACTICE IMPLICATIONS


To improve participation rate assessment of patient's needs and close cooperation with rehabilitation centers, psychosocial counseling services, and medical oncologists are recommended.",2020,"For all other outcome criteria such as depressive symptoms, social support, or quality of life, no significant changes over time or differences between both groups were found.
","['50 breast cancer patients participated (intervention group n\u2009=\u200927, control group n\u2009=\u200923', 'breast cancer patients', 'breast cancer survivors', 'Breast cancer patients']","['outpatient psychoeducational group program', 'Psychoeducational group intervention']","['self-efficacy (SE', 'fear of progression/recurrence (FoPR', 'fear of recurrence', 'fear of progression, self-efficacy, depression, and quality of life', 'depressive symptoms, social support, or quality of life']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0037438'}]",50.0,0.0215598,"For all other outcome criteria such as depressive symptoms, social support, or quality of life, no significant changes over time or differences between both groups were found.
","[{'ForeName': 'Joachim B', 'Initials': 'JB', 'LastName': 'Weis', 'Affiliation': 'Comprehensive Cancer Center Department of Cancer Self-Help Research, Medical Center University Freiburg, Hugstetter Str. 49, 79106, Freiburg, Germany. joachim.weis@uniklinik-freiburg.de.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Gschwendtner', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Giesler', 'Affiliation': 'Institute of Medical Biometry und Statistics, Section of Health Services Research and Rehabilitation Research, Medical Center University Freiburg, Breisgau, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Adams', 'Affiliation': 'Department of Public Health and Education, University of Education, Freiburg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Wirtz', 'Affiliation': 'Department of Research Methods, University of Education, Freiburg, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05076-6']
1307,31354153,Asymmetric sinus excision and primary closure with additional skin excision technique. Effect of reduction of dead-space with Karydakis modification.,"OBJECTIVE


Pilonidal sinus is one of the common diseases, although there is still no gold standard of treatment available. The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.
METHODS


A total of 100 patients were included in a randomised controlled trial, who were divided into two groups. Each group included 50 patients, and the patients in Group-1 were treated with the new technique, whereas in Group- 2, the standard Karydakis technique was performed. In the new technique, following total sinus excision, an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.
RESULTS


There was no significant difference in terms of sex, age, and sinus volume. Operation time was longer in first group (p=0,002). Seroma formation rate was higher in the secound group (p=0.036). There was no significant difference in terms of soft tissue infection (p=0.339) and wound dehiscence (p=0.218). The mean follow-up period was 30 months and no recurrence was observed in both groups.
CONCLUSIONS


The results of the study suggest that this technique may be considered as an alternative surgical method in pilonidal sinus surgery.
KEY WORDS


Dead, Karydakis flap-space volume, Sacrococcygeal pilonidal sinus, Seroma, Skin excision.",2019,There was no significant difference in terms of soft tissue infection (p=0.339) and wound dehiscence (p=0.218).,['A total of 100 patients'],['Asymmetric sinus excision and primary closure with additional skin excision technique'],"['soft tissue infection', 'Operation time', 'Seroma formation rate', 'wound dehiscence', 'Dead, Karydakis flap-space volume, Sacrococcygeal pilonidal sinus, Seroma, Skin excision', 'sex, age, and sinus volume']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0149778', 'cui_str': 'Soft Tissue Infection'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]",100.0,0.0129314,There was no significant difference in terms of soft tissue infection (p=0.339) and wound dehiscence (p=0.218).,"[{'ForeName': 'Abdulcabbar', 'Initials': 'A', 'LastName': 'Kartal', 'Affiliation': ''}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Yalçın', 'Affiliation': ''}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Oter', 'Affiliation': ''}, {'ForeName': 'Murat Ferhat', 'Initials': 'MF', 'LastName': 'Ferhatoğlu', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Uzunköy', 'Affiliation': ''}]",Annali italiani di chirurgia,[]
1308,31584721,Randomized Controlled Trial of the Marriage Checkup: Depression Outcomes.,"The association between relationship functioning and depressive symptoms is well established. This study examined the effects of the Marriage Checkup, a brief two-session Assessment and Feedback relationship intervention, on depressive symptoms. Two hundred and nine married couples participated in the Marriage Checkup and were randomized into Treatment (N = 108) and Waitlist-Control Conditions (N = 101). Compared to the control condition, intervention participants reported significant improvements in depressive symptoms (d = 0.55), with an even greater effect for those who were reporting more severe baseline depression symptoms (d = 0.67). These outcomes are comparable to those within long-term individual psychotherapy, couple therapy, and pharmacology trials, making this the briefest intervention to date to demonstrate significant improvements in depressive symptoms. Clinical implications are discussed.",2020,"Compared to the control condition, intervention participants reported significant improvements in depressive symptoms (d = 0.55), with an even greater effect for those who were reporting more severe baseline depression symptoms (d = 0.67).",['Two hundred and nine married couples participated in the Marriage Checkup'],"['Marriage Checkup, a brief two-session Assessment and Feedback relationship intervention']","['depressive symptoms', 'severe baseline depression symptoms']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0402276,"Compared to the control condition, intervention participants reported significant improvements in depressive symptoms (d = 0.55), with an even greater effect for those who were reporting more severe baseline depression symptoms (d = 0.67).","[{'ForeName': 'Tatiana D', 'Initials': 'TD', 'LastName': 'Gray', 'Affiliation': 'Clark University.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hawrilenko', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Cordova', 'Affiliation': 'Clark University.'}]",Journal of marital and family therapy,['10.1111/jmft.12411']
1309,32412872,"Investigation of the effects of veterinarians' attire on ratings of trust, confidence, and comfort in a sample of pet owners in Canada.","OBJECTIVE


To examine companion animal owners' perceptions of appropriate veterinarian attire and investigate potential associations between a veterinarian's attire and clients' ratings of trust in, confidence in, and comfort with a veterinarian.
SAMPLE


449 pet owners.
PROCEDURES


Participants were randomly assigned to complete a questionnaire containing photos of a male or female model veterinarian photographed in 8 attire types (formal attire, white dress shirt with black pants, white casual shirt with khaki pants, surgical scrubs, white casual shirt with jeans, surgical scrub top with jeans, surgical scrub top with khaki pants, and white laboratory coat with khaki pants). Participants were asked to rate their trust in, confidence in, and comfort with the pictured individual on a response scale of 1 (low) to 7 (high), rank photos according to their preferences for attire, and provide input on the importance of attire and other appearance-related subjects. Attire and gender of photographed individual and participant demographics were investigated for associations with trust, confidence, and comfort scores.
RESULTS


Most (317/445 [71%]) respondents indicated veterinarians' attire was important. Attire type was significantly associated with respondents' trust, confidence, and comfort scores. Model veterinarian gender and participant education level were also associated with trust and comfort scores.
CONCLUSIONS AND CLINICAL RELEVANCE


Veterinarians' attire is a form of nonverbal communication that is likely to inform clients' first impressions and may influence clients' trust in, confidence in, and comfort with a veterinarian. Veterinary personnel and veterinary management should consider how attire and general appearance represent staff members or their practice.",2020,"Attire type was significantly associated with respondents' trust, confidence, and comfort scores.","['SAMPLE\n\n\n449 pet owners', 'sample of pet owners in Canada', 'Participants']","[""veterinarians' attire"", 'questionnaire containing photos of a male or female model veterinarian photographed in 8 attire types (formal attire, white dress shirt with black pants, white casual shirt with khaki pants, surgical scrubs, white casual shirt with jeans, surgical scrub top with jeans, surgical scrub top with khaki pants, and white laboratory coat with khaki pants']","['ratings of trust, confidence, and comfort']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0242856', 'cui_str': 'Veterinarian'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing'}, {'cui': 'C2936698', 'cui_str': 'Scrubbing, Surgical'}, {'cui': 'C0453932', 'cui_str': 'Jeans'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0405637,"Attire type was significantly associated with respondents' trust, confidence, and comfort scores.","[{'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Coe', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Pizzolon', 'Affiliation': ''}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Hester', 'Affiliation': ''}, {'ForeName': 'Leandra J', 'Initials': 'LJ', 'LastName': 'Nogueira Borden', 'Affiliation': ''}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Haley', 'Affiliation': ''}]",Journal of the American Veterinary Medical Association,['10.2460/javma.256.11.1268']
1310,30104729,Translating advice to eat more vegetables into practice: observations from a 12-month weight loss trial.,"OBJECTIVES


This study aimed to identify the main vegetable sources of overweight participants during a 12-month randomised controlled trial for weight loss.
METHODS


Secondary analysis using data from diet history interviews to determine changes to daily vegetable intake amounts and types throughout the trial at 0, 3 and 12 months.
RESULTS


Pre-trial 77% participants consumed frozen vegetables. At baseline (n = 113, 85 F), participants reported 345 ± 170 (56-920) g/day vegetables increasing to 498 ± 180 (146-930) g/day at 3 months and remaining stable at 475 ± 169(170-1053) g/day by 12 months (p = 0.001). At baseline, 32 of 34 different vegetable categories were reported, mainly tomato (69.9 g/day) and, potato (58.2 g/day). After 3 months (n = 109), seven vegetables remained in the top 10 reported (contributing 72%). Tomato remained top ranked to 12 months.
CONCLUSION


Following advice to consume more vegetables, consumption increased above the Australian Dietary recommendation of ~375 g/day. Tomatoes remained a mainstay regardless of the time of year, but choices changed with time. Frozen vegetables may be a feasible option.",2019,"At baseline (n = 113, 85 F), participants reported 345 ± 170 (56-920) g/day vegetables increasing to 498 ± 180 (146-930) g/day at 3 months and remaining stable at 475 ± 169(170-1053) g/day by 12 months (p = 0.001).",['overweight participants'],[],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]",[],[],,0.244299,"At baseline (n = 113, 85 F), participants reported 345 ± 170 (56-920) g/day vegetables increasing to 498 ± 180 (146-930) g/day at 3 months and remaining stable at 475 ± 169(170-1053) g/day by 12 months (p = 0.001).","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': ""O'Shea"", 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tapsell', 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Thorne', 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Probst', 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia. yasmine@uow.edu.au.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0277-9']
1311,32026495,Randomized Clinical Trial Comparing Two Methods of Measuring Insertion Length of Nasogastric Tubes in Newborns.,"INTRODUCTION


The selection of a method for measuring the insertion length of nasogastric tubes in newborns is an important factor in establishing the safe use of this device.
OBJECTIVE


The objective was to verify whether there is a difference in the proportion of correctly placed nasogastric tubes when using the nose, earlobe, mid-umbilicus (NEMU) method and the weight-based equation for measuring the insertion length.
METHODS


This study is a randomized, controlled, blinded study comparing 2 methods of nasogastric insertion at a neonatal unit, with intensive and intermediate care, on 162 randomized individuals. Radiological assessment and pH test were conducted to verify tube placement. Data were collected on sex, birth weight, gestational age, and days of life. A log-binomial model was used to verify whether there were placement differences between investigated methods.
RESULTS


Of the patients, 56.1% were male, who had a mean birth weight of 1886.8 g and gestational age of 32.9 weeks and were 10.8 days old. Radiological images demonstrated that tubes were properly placed in the gastric body in 67.5% of patients using the NEMU method and in 91.5% using the weight-based equation: the weight-based equation was superior to the NEMU method, with a prevalence ratio of 1.36 (95% CI, 1.15-1.44). There was no difference between the 2 methods, according to pH test (P-value: .7179).
CONCLUSION


Based on radiographic confirmation, the weight-based equation for measuring the insertion length of the nasogastric tube in newborns resulted in significantly more nasogastric tubes being placed in the correct intragastric location.",2020,"Radiological images demonstrated that tubes were properly placed in the gastric body in 67.5% of patients using the NEMU method and in 91.5% using the weight-based equation: the weight-based equation was superior to the NEMU method, with a prevalence ratio of 1.36 (95% CI, 1.15-1.44).","['Newborns', '162 randomized individuals', 'Of the patients, 56.1% were male, who had a mean birth weight of 1886.8 g and gestational age of 32.9 weeks and were 10.8 days old']","['nasogastric insertion at a neonatal unit, with intensive and intermediate care']",[],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",[],162.0,0.0772818,"Radiological images demonstrated that tubes were properly placed in the gastric body in 67.5% of patients using the NEMU method and in 91.5% using the weight-based equation: the weight-based equation was superior to the NEMU method, with a prevalence ratio of 1.36 (95% CI, 1.15-1.44).","[{'ForeName': 'Flávia de Souza Barbosa', 'Initials': 'FSB', 'LastName': 'Dias', 'Affiliation': 'School of Nursing, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Menezes', 'Initials': 'RM', 'LastName': 'Jales', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Beatriz Regina', 'Initials': 'BR', 'LastName': 'Alvares', 'Affiliation': 'Department of Radiology, School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Jamil Pedro de Siqueira', 'Initials': 'JPS', 'LastName': 'Caldas', 'Affiliation': 'Department of Pediatrics, School of Medical Sciences, University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Elenice Valentim', 'Initials': 'EV', 'LastName': 'Carmona', 'Affiliation': 'School of Nursing, University of Campinas, São Paulo, Brazil.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1786']
1312,31570825,Transcutaneous functional electrical stimulation-a novel therapy for premature ejaculation: results of a proof of concept study.,"Premature Ejaculation (PE) is a very common and disturbing sexual dysfunction in men. Currently available treatment modalities are associated with limited efficacy and low treatment adherence. In this prospective, single-blinded, self-controlled study, we evaluated the efficacy and safety of transcutaneous electrical stimulation (TES) for the treatment of (PE). We included 23 patients aged 20-60 (mean: 38.7) with lifelong PE. On the first visit, we delivered either TES or sham treatment to the perineum, based on the enrollment order. For stimulation, we used a commercial neuromuscular electrical stimulation device. The patients were invited for the second visit after at least 7 days for receiving the alternating treatment. During the treatment sessions, the patients were left alone in a privet silent room to masturbate and a stopwatch was used to measure their masturbation ejaculatory latency time (MELT). The patients also filled-out safety questionnaires after each visit and on each of the 3 following days. Of the 20 patients who completed the study, 17 (85%) experienced prolonged MELT under TES compared with the sham treatment. Mean MELT values increased 3.5-folds under TES (p = 0.0009). We demonstrated a significant increase in MELT in lifelong PE patients using TES. This therapeutic option may have the potential to become an on-demand treatment option for PE. Future studies with wireless devices are needed to confirm the efficacy and safety of this treatment concept during intercourse.",2020,"Of the 20 patients who completed the study, 17 (85%) experienced prolonged MELT under TES compared with the sham treatment.","['23 patients aged 20-60 (mean: 38.7) with lifelong PE', 'premature ejaculation']","['Transcutaneous functional electrical stimulation-a novel therapy', 'TES', 'transcutaneous electrical stimulation (TES']","['masturbation ejaculatory latency time (MELT', 'prolonged MELT under TES', 'Mean MELT values', 'MELT', 'Premature Ejaculation (PE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C0024906', 'cui_str': 'Masturbation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0599882', 'cui_str': 'Melting'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]",,0.0182798,"Of the 20 patients who completed the study, 17 (85%) experienced prolonged MELT under TES compared with the sham treatment.","[{'ForeName': 'Arik', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel. arikshec@gmail.com.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Serefoglu', 'Affiliation': 'Department of Urology, Biruni University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Gollan', 'Affiliation': 'Virility Medical Ltd., Nazareth, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Physical Therapy Department, Faculty of Health Sciences Ariel University, Ariel, Israel.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Meiry', 'Affiliation': 'Virility Medical Ltd., Nazareth, Israel.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Appel', 'Affiliation': 'Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Gruenwald', 'Affiliation': 'Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel.'}]",International journal of impotence research,['10.1038/s41443-019-0207-y']
1313,27859619,Treatment of Adolescent PTSD: The Impact of Prolonged Exposure Versus Client-Centered Therapy on Co-Occurring Emotional and Behavioral Problems.,"The present study evaluated secondary emotional and behavioral outcomes among adolescents who received prolonged exposure (PE-A) or client-centered therapy (CCT) for posttraumatic stress disorder (PTSD) in a randomized controlled trial. Participants were 61 adolescent girls (age: M = 15.33, SD = 1.50 years) with sexual abuse related PTSD seeking treatment at a community mental health clinic. Multilevel modeling was employed to evaluate group differences on the Youth Self-Report (YSR) over acute treatment and 12-month follow-up. Both treatment groups showed significant improvements on all YSR scales from baseline to 12-month follow-up. Adolescents who received PE-A showed significantly greater reductions than those receiving CCT on the Externalizing subscale (d = 0.70), rule-breaking behavior (d = 0.63), aggressive behavior (d = 0.62), and conduct problems (d = 0.78). No treatment differences were found on the Internalizing subscale or among other YSR problem areas. Both PE-A and CCT effectively reduced many co-occurring problems among adolescents with PTSD. Although PE-A focuses on PTSD and not on disruptive behaviors, PE-A was associated with greater sustained changes in externalizing symptoms, supporting broad effects of trauma-focused treatment on associated problem areas.",2016,"Adolescents who received PE-A showed significantly greater reductions than those receiving CCT on the Externalizing subscale (d = 0.70), rule-breaking behavior (d = 0.63), aggressive behavior (d = 0.62), and conduct problems (d = 0.78).","['Participants were 61 adolescent girls (age: M = 15.33, SD = 1.50 years) with sexual abuse related PTSD seeking treatment at a community mental health clinic', 'adolescents who received', 'Adolescent PTSD', 'adolescents with PTSD']","['PE-A and CCT', 'Prolonged Exposure Versus Client-Centered Therapy', 'CCT', 'prolonged exposure (PE-A) or client-centered therapy (CCT']","['YSR scales', 'Youth Self-Report (YSR', 'rule-breaking behavior', 'Internalizing subscale', 'aggressive behavior', 'Externalizing subscale', 'externalizing symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse (event)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0028302', 'cui_str': 'Nondirective Therapy'}]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",61.0,0.0159192,"Adolescents who received PE-A showed significantly greater reductions than those receiving CCT on the Externalizing subscale (d = 0.70), rule-breaking behavior (d = 0.63), aggressive behavior (d = 0.62), and conduct problems (d = 0.78).","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zandberg', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Antonia N', 'Initials': 'AN', 'LastName': 'Kaczkurkin', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Rescorla', 'Affiliation': 'Department of Psychology, Bryn Mawr College, Bryn Mawr, Pennsylvania, USA.'}, {'ForeName': 'Elna', 'Initials': 'E', 'LastName': 'Yadin', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Journal of traumatic stress,['10.1002/jts.22138']
1314,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE


Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial.
MATERIAL AND METHODS


A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed.
RESULTS


Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
CONCLUSION


Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006']
1315,32413238,Pharmacokinetics and Bioequivalence of 2 Olanzapine Orally Disintegrating Tablet Products in Healthy Chinese Subjects Under Fed and Fasting Conditions.,"To assess the bioequivalence of two 5-mg olanzapine orally disintegrating tablet (ODT) products, 2 randomized, open-label, single-dose, 2-way crossover studies were carried out under fasting or fed conditions. Blood samples were collected at scheduled times according to the study protocol. Statistical analysis of area under the concentration-time curve from time 0 to 168 hours (AUC 0-t  ), area under the curve from time zero to infinity (AUC 0-∞  ), and peak plasma concentration (C max  ) was conducted. Two formulations were considered bioequivalent if the 90% confidence intervals (CIs) of the geometric mean ratios for AUC 0-t,  AUC 0-∞  , and C max  were within the range of 0.80-1.25. Adverse events were recorded and evaluated throughout the studies. A total of 48 subjects with 24 in each study completed the 2 studies. In fasted subjects, the 90%CIs for the test product versus the reference product were 97.28%-105.13% for AUC 0-t  , 97.57%-105.54% for AUC 0-∞  , and 90.94%-103.97% for C max  . In fed subjects, the 90%CIs for AUC 0-t  , AUC 0-∞  and C max  were 99.73%-122.63%, 99.56%-121.75%, and 99.46%-120.46%, respectively. No serious adverse events were reported in the studies. The reference and the test product of 5-mg olanzapine ODT show comparable pharmacokinetic profiles under both fed and fasted conditions and were considered bioequivalent.",2020,No serious adverse events were reported in the studies.,"['48 subjects with 24 in each study completed the 2 studies', 'Healthy Chinese Subjects Under Fed and Fasting Conditions']","['olanzapine', 'Olanzapine Orally Disintegrating Tablet Products', 'olanzapine ODT']","['serious adverse events', 'peak plasma concentration', '90%CIs for AUC 0-t  , AUC 0-∞  and C max', 'Adverse events']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1248714', 'cui_str': 'olanzapine Disintegrating Oral Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",48.0,0.0358422,No serious adverse events were reported in the studies.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'QILU Pharmaceutical, Jinan, Shandong, China.'}, {'ForeName': 'Hongquan', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yunfang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianghui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.765']
1316,32413431,Anchor vs suture for the attachment of vaginal mesh in a robotic-assisted sacrocolpopexy: a randomized clinical trial.,"BACKGROUND


Vaginal mesh attachment can be one of the most time-consuming components of a minimally invasive sacrocolpopexy.
OBJECTIVE


To assess the impact on the duration vaginal mesh attachment of using absorbable anchors compared to interrupted sutures for vaginal mesh attachment in robotic-assisted sacrocolpopexy.
STUDY DESIGN


This was a single-masked, randomized clinical trial of women with pelvic organ prolapse that underwent a robotic-assisted sacrocolpopexy at 2 clinical sites. The participants were randomized to receive either interrupted delayed absorbable anchors or sutures during the vaginal mesh attachment portion of the surgery. The participants completed validated questionnaires at baseline and at 6 weeks, 6 months, and 12 months after the surgery. A certified examiner, masked to the attachment technique that was used, performed a clinical examination using the Pelvic Organ Prolapse Quantification system and also assessed for mesh exposure and the overall appearance of the vaginal walls using a 10-cm visual analog scale at each follow-up visit. The primary outcome was the vaginal mesh attachment time. The categorical variables were compared using chi-square or Fischer's Exact test, whereas the continuous variables were compared using Student's t-test or Mann-Whitney U test where appropriate. An intention-to-treat analysis was performed.
RESULTS


Fifty-three participants were randomized, 26 to mesh attachment with anchor, 27 to mesh attachment with suture, and 81% (21/26) and 93% (25/27) had 12-month follow up respectively. There were no significant differences between the groups with regard to age (P=.12), body mass index (P=.23), stage of prolapse (P=.97), or other preoperative factors. Mesh attachment interval time was faster in the anchor compared to suturing study arm (12.2±7.8 vs 21.2±5.2 minutes; P<.001), while sacrocolpopexy times (107.6±33.2 vs 109.8±21.2 minutes; P=.774) were not different. The ease of placement for the surgeon based on a visual analog scale (P=.16), the appearance of the mesh attachment (P=.07), and the overall satisfaction with the use of the specific attachment type (P=.65) were similar for the arms. There was no difference in perioperative adverse events rates between arms and by 12 months follow-up there were no sacrocolpopexy mesh, anchor, or suture exposures. There was no difference in outcomes at 12 months including composite failure (10% vs 12%; P=.79), patient global impression of improvement (1.06 vs 1.19; P=.27), or patient pelvic pain (9.81 vs 9.67; P=.56).
CONCLUSION


In patients undergoing a robotic-assisted sacrocolpopexy, the anchor vaginal mesh attachment technique required significantly less time than suturing. There was no difference between techniques in complications, failure, surgeon, or patient-reported outcomes through 12 months of follow-up. Mesh attachment during sacrocolpopexy can be performed in less time by using the anchor technique, providing surgeons with an alternative surgical technique for this procedure.",2020,"There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up.","['patients undergoing', 'women with pelvic organ prolapse undergoing robotic-assisted sacrocolpopexy', 'Fifty-three participants']","['robotic-assisted sacrocolpopexy the anchor vaginal mesh attachment technique', 'VAS', 'Anchor versus Suture for Attachment of Vaginal Mesh in Robotic-Assisted Sacrocolpopexy', 'interrupted delayed-absorbable anchors or sutures', 'absorbable anchors compared to interrupted sutures']","['Mesh attachment interval time', 'patient global impression of improvement', 'patient pelvic pain', 'composite failure', 'vaginal mesh attachment time', 'BMI (p=0.23), stage of prolapse', 'perioperative adverse events rates', 'global satisfaction', 'appearance of mesh attachment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",53.0,0.29178,"There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Berger', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego Medical Center, San Diego, CA; Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Science, University of California San Diego, San Diego, CA. Electronic address: alexanderbergermd@gmail.com.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Tan-Kim', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego Medical Center, San Diego, CA.'}, {'ForeName': 'Shawn A', 'Initials': 'SA', 'LastName': 'Menefee', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego Medical Center, San Diego, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.018']
1317,27790554,Comparison between Thoracic Epidural Block and Thoracic Paravertebral Block for Post Thoracotomy Pain Relief.,"INTRODUCTION


Postoperative pain after thoracotomy is being considered one of the most severe pain and if not treated well, can result in various respiratory and other complications.
AIM


Present study was conducted with the aim to compare continuous thoracic epidural infusion with continuous paravertebral infusion for postoperative pain using Visual Analogue Scale (VAS) score and four point observer ranking. The secondary outcomes measured were pulmonary functions and any complication like hypotension, bradycardia, nausea, vomiting, urinary retention and neurological complications if any.
MATERIALS AND METHODS


Sixty patients of age group 18-60 years posted for anterolateral thoracotomy surgery for lung resection were randomised either to epidural or paravertebral group in this randomised prospective double blind study. In Epidural group 7.5ml bolus of 0.125% Bupivacaine with 50μg Fentanyl and in Paravertebral group 15ml bolus of 0.125% Bupivacaine with 50μg Fentanyl was given 30 minutes before the anticipated end of surgery. Bolus dose was followed by infusion of 0.125% Bupivacaine with 2μg/ml Fentanyl at the rate of 5 ml/hr in both groups. Parameters noted were Mean Arterial Pressure (MAP), Heart Rate (HR), Oxygen Saturation (SpO 2 ), Arterial Blood Gas (PaCO 2 , P/F ratio), Visual Analogue Scale (VAS) and Four Point Observer Ranking Scale (FPORS) for pain, number of sensory segments blocked (by checking for pinprick sensation), requirement of infusion top ups and rescue analgesia (Tramadol), pre and postoperative pulmonary function test {(Forced Expiratory Volume (FEV) 1 , Forced Vital Capacity (FVC), FEV 1 /FVC, Peak Expiratory Flow Rate (PEFR)} and complications from start of infusion till 24 hours in the postoperative period.
RESULTS


Both the techniques were effective in relieving pain but pain relief was significantly better with epidural. Postoperatively, HR, SpO 2 , P/F ratio and PaCO 2  were comparable between group E and P. There was significant decline in FeV 1 , FVC, FeV 1 /FVC and PEFR in postoperative period as compared to preoperative value in both the groups. Hypotension and bradycardia were more in group E.
CONCLUSION


Both the techniques, continuous thoracic epidural block and continuous thoracic paravertebral block were effective for post-thoracotomy pain relief; however, epidural block provides better pain relief. The incidence of sympatholytic complications was more in epidural group. The effect on respiratory mechanics was equivalent. Hence, paravertebral block can be used in post thoracotomy pain relief in those patients where thoracic epidural is contraindicated.",2016,"There was significant decline in FeV 1 , FVC, FeV 1 /FVC and PEFR in postoperative period as compared to preoperative value in both the groups.",['Sixty patients of age group 18-60 years posted for'],"['Bupivacaine with 2μg/ml Fentanyl', 'Bupivacaine with 50μg Fentanyl and in Paravertebral group 15ml bolus of 0.125% Bupivacaine with 50μg Fentanyl', 'epidural or paravertebral group', 'continuous thoracic epidural infusion with continuous paravertebral infusion', 'Thoracic Epidural Block and Thoracic Paravertebral Block', 'anterolateral thoracotomy surgery for lung resection']","['relieving pain but pain relief', 'Mean Arterial Pressure (MAP), Heart Rate (HR), Oxygen Saturation (SpO 2 ), Arterial Blood Gas (PaCO 2 , P/F ratio), Visual Analogue Scale (VAS) and Four Point Observer Ranking Scale (FPORS) for pain, number of sensory segments blocked (by checking for pinprick sensation), requirement of infusion top ups and rescue analgesia (Tramadol), pre and postoperative pulmonary function test {(Forced Expiratory Volume (FEV) 1 , Forced Vital Capacity (FVC), FEV 1 /FVC, Peak Expiratory Flow Rate (PEFR)} and complications', 'Postoperatively, HR, SpO 2 , P/F ratio and PaCO 2', 'Hypotension and bradycardia', 'sympatholytic complications', 'pulmonary functions and any complication like hypotension, bradycardia, nausea, vomiting, urinary retention and neurological complications if any', 'postoperative pain using Visual Analogue Scale (VAS) score', 'pain relief', 'FeV 1 , FVC, FeV 1 /FVC and PEFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0394835', 'cui_str': 'Local anesthetic thoracic epidural block (procedure)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0442950', 'cui_str': 'Anterolateral thoracotomy (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0039051', 'cui_str': 'Sympatholytic Agents'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030735', 'cui_str': 'PEFR'}]",60.0,0.117508,"There was significant decline in FeV 1 , FVC, FeV 1 /FVC and PEFR in postoperative period as compared to preoperative value in both the groups.","[{'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': ""Resident, Department of Anaesthesiology, King George's Medical University , Lucknow, Uttar Pradesh, India .""}, {'ForeName': 'Reetu', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': ""Associate Professor, Department of Anaesthesiology, King George's Medical University , Lucknow, Uttar Pradesh, India .""}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Bhatia', 'Affiliation': ""Professor, Department of Anaesthesiology, King George's Medical University , Lucknow, Uttar Pradesh, India .""}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Chaudhary', 'Affiliation': ""Additional Professor, Department of Anaesthesiology, King Gorge's Medical University , Lucknow, Uttar Pradesh, India .""}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Chandra', 'Affiliation': ""Professor, Department of Anaesthesiology, King Gorge's Medical University , Lucknow, Uttar Pradesh, India .""}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Prakash', 'Affiliation': ""Senior Resident, Department of Anaesthesiology, King George's Medical University , Lucknow, Uttar Pradesh, India .""}]",Journal of clinical and diagnostic research : JCDR,[]
1318,27765756,Safety and efficacy of nivolumab and standard chemotherapy drug combination in patients with advanced non-small-cell lung cancer: a four arms phase Ib study.,"BACKGROUND


The human IgG4 monoclonal antibody nivolumab targets programmed cell death-1 (PD-1) and promotes antitumor response by blocking the interaction of PD-1 with its ligands. This single-center phase Ib study investigated the tolerability, safety, and pharmacokinetics of nivolumab combined with standard chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS


Patients who had stage IIIB without indication for definitive radiotherapy, stage IV, or recurrent NSCLC were eligible. Regimens were nivolumab 10 mg/kg + gemcitabine/cisplatin (arm A), pemetrexed/cisplatin (arm B), paclitaxel/carboplatin/bevacizumab (arm C), or docetaxel (arm D). Regimens A, B, and D were repeated every 3 weeks for up to four cycles and regimen C was repeated for up to six cycles; nivolumab alone (arm A), with pemetrexed (arm B), bevacizumab (arm C), or docetaxel (arm D) was continued every 3 weeks as maintenance therapy until disease progression or unacceptable toxicity. Dose-limiting toxicity (DLT) was evaluated during the first treatment cycle.
RESULTS


As of March 2014, six patients were enrolled in each arm. The combination of nivolumab 10 mg/kg and chemotherapy was well tolerated. DLT was observed in only one patient in arm A (alanine aminotransferase increased). Select adverse events (those with a potential immunologic cause) of any grade were observed in six, four, six, and five patients in arms A, B, C, and D, respectively. Three, three, six, and one patient achieved partial response while median progression-free survival was 6.28, 9.63 months, not reached, and 3.15 months in arms A, B, C, and D, respectively.
CONCLUSIONS


Combination of nivolumab 10 mg/kg and chemotherapy showed an acceptable toxicity profile and encouraging antitumor activity in patients with advanced NSCLC.
CLINICAL TRIALS NUMBER


Japanese Pharmaceutical Information Center Clinical Trials Information (JapicCTI)-132071.",2016,DLT was observed in only one patient in arm A (alanine aminotransferase increased).,"['patients with advanced non-small-cell lung cancer', 'Patients who had stage IIIB without indication for definitive radiotherapy, stage IV, or recurrent NSCLC were eligible', 'patients with advanced NSCLC', 'patients with advanced non-small-cell lung cancer (NSCLC']","['nivolumab 10 mg/kg and chemotherapy', 'nivolumab 10 mg/kg + gemcitabine/cisplatin (arm A), pemetrexed/cisplatin (arm B), paclitaxel/carboplatin/bevacizumab (arm C), or docetaxel (arm D', 'nivolumab alone (arm A), with pemetrexed (arm B), bevacizumab (arm C), or docetaxel', 'nivolumab and standard chemotherapy drug combination', 'nivolumab combined with standard chemotherapy']","['DLT', 'tolerated', 'partial response while median progression-free survival', 'tolerability, safety, and pharmacokinetics', 'Safety and efficacy', 'acceptable toxicity profile and encouraging antitumor activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013162', 'cui_str': 'Drug Combinations'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",6.0,0.1578,DLT was observed in only one patient in arm A (alanine aminotransferase increased).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo skanda@ncc.go.jp.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kubo', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Utsumi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kitazono', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mizugaki', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hozumi', 'Affiliation': 'ONO Pharmaceutical Co. Ltd, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw416']
1319,31907323,Cautionary study on the effects of pay for performance on quality of care: a pilot randomised controlled trial using standardised patients.,"BACKGROUND


Due to the difficulty of studying incentives in practice, there is limited empirical evidence of the full-impact pay-for-performance (P4P) incentive systems.
OBJECTIVE


To evaluate the impact of P4P in a controlled, simulated environment.
DESIGN


We employed a simulation-based randomised controlled trial with three standardised patients to assess advanced practice providers' performance. Each patient reflected one of the following: (A) indicated for P4P screenings, (B) too young for P4P screenings, or (C) indicated for P4P screenings, but screenings are unrelated to the reason for the visit. Indication was determined by the 2016 Centers for Medicare and Medicaid Services quality measures.
INTERVENTION


The P4P group was paid $150 and received a bonus of $10 for meeting each of five outcome measures (breast cancer, colorectal cancer, pneumococcal, tobacco use and depression screenings) for each of the three cases (max $300). The control group received $200.
SETTING


Learning resource centre.
PARTICIPANTS


35 advanced practice primary care providers (physician assistants and nurse practitioners) and 105 standardised patient encounters.
MEASUREMENTS


Adherence to incentivised outcome measures, interpersonal communication skills, standards of care, and misuse.
RESULTS


The  Type a  patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027). The  Type b  patient was more likely to be prescribed screenings not indicated, but highlighted by P4P: breast cancer screening (47% P4P vs 0% control, p<0.01) and colorectal cancer screening (24% P4P vs 0% control, p=0.03). The P4P group over-reported completion of incentivised measures resulting in overpayment (average of $9.02 per patient).
LIMITATIONS


A small sample size and limited variability in patient panel limit the generalisability of findings.
CONCLUSIONS


Our findings caution the adoption of P4P by highlighting the unintended consequences of the incentive system.",2020,"The  Type a  patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027).","[""three standardised patients to assess advanced practice providers' performance"", '35 advanced practice primary care providers (physician assistants and nurse practitioners) and 105 standardised patient encounters.\nMEASUREMENTS', 'Learning resource centre']",[],"['quality of care', 'P4P screenings', 'interpersonal communication skills, standards of care, and misuse', 'colorectal cancer screening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]",35.0,0.114741,"The  Type a  patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Green', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona, USA ellen.green@asu.edu.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Peterson', 'Affiliation': 'Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Markiewicz', 'Affiliation': 'Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Noel M', 'Initials': 'NM', 'LastName': 'Arring', 'Affiliation': 'Department of Systems, Population and Leadership, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010260']
1320,32090585,"Effect of a double nutritional intervention on the nutritional status, functional capacity, and quality of life of patients with chronic heart failure: 12-month results from a randomized clinical trial.","Introduction


Introduction: malnutrition is commonly associated with, and worsens the prognosis of heart failure. The management of chronic heart failure and its complications based only on the application of pharmacologic guidelines is incomplete. The benefits of interventions to improve nutritional status may be limited by the multifactorial nature of malnutrition. The objective of the present study was to determine whether nutritional advice and nutritional supplementation can improve the nutritional status of patients with chronic heart failure. Methods: we performed a randomized clinical trial on an intention-to-treat basis with blinded observers. We divided a sample of 76 patients into 2 groups: one that received structured advice combined with nutritional supplements for 12 weeks (test group), and one that received treatment as usual (control group). The outcome measure was nutritional status as evaluated using the Subjective Global Assessment and the Mini Nutritional Assessment tools. After 12 weeks of treatment the test group received a leaflet that served as a reminder. No further interventions were applied in either group. Patients were followed for 1 year. Results: at 3 months of follow-up nutritional status improved 4-fold in the test group, whereas no change was observed in the control group. At 9 months nutritional status in the intervention group had improved 2-fold with respect to the baseline visit, whereas no differences were recorded in the control group. Differences in mortality and length of stay at 1 year did not reach statistical significance.",2020,Differences in mortality and length of stay at 1 year did not reach statistical significance.,"['patients with chronic heart failure', '76 patients into 2 groups: one that received']","['double nutritional intervention', 'nutritional advice and nutritional supplementation', 'structured advice combined with nutritional supplements']","['nutritional status, functional capacity, and quality of life', 'mortality and length of stay', 'nutritional status as evaluated using the Subjective Global Assessment and the Mini Nutritional Assessment tools']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",76.0,0.0224267,Differences in mortality and length of stay at 1 year did not reach statistical significance.,"[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Guerra-Sánchez', 'Affiliation': 'Instituto de Investigación Biomedica Gregorio Marañón. Hospital General Universitario Gregorio Marañón. Facultad Enfermería,fisiot. y podol. Universidad Complutense de Madrid.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Fresno-Flores', 'Affiliation': 'Hospital General Gregorio Universitario Marañón.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez-Rincón', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología. Universidad Complutense de Madrid.'}]",Nutricion hospitalaria,['10.20960/nh.02820']
1321,29990524,Doggy bags and downsizing: Packaging uneaten food to go after a meal attenuates the portion size effect in women.,"Serving larger portions leads to increased food and energy intake, but little is known about strategies to moderate this response. This study tested how the effect of portion size on meal intake was influenced by providing the option to take away uneaten food in a ""doggy bag"" (to-go container). Women were randomly assigned to one of two subject groups: a To-Go Group (n = 27) that was informed before each meal that their leftover food would be packaged to take away after the meal, and a Control Group (n = 26) that was not given this option. In a crossover design, subjects came to the lab once a week for four weeks to eat a dinner composed of five foods. Across meals, the portion size of all foods was varied (100%, 125%, 150%, and 175% of baseline). Results showed that the portion size effect, defined as the trajectory of intake across the weight of food served, differed significantly by subject group (P ≤ 0.025). In the Control Group, increasing the portion size of all foods led to substantial increases in intake (P < 0.0001); for every 100 g added to the baseline portion, women in this group consumed an additional mean (±SEM) of 64 ± 12 g of food and 90 ± 19 kcal, until intake leveled off. In contrast, intake of women in the To-Go Group increased by only 17 ± 12 g and 19 ± 18 kcal for every additional 100 g served; these increases did not differ significantly from zero (P > 0.15). Thus, the effect of portion size on intake was attenuated in the To-Go Group compared to the Control Group. These data indicate that packaging uneaten food after a meal could be an effective strategy to reduce overconsumption from large portions.",2018,"In the Control Group, increasing the portion size of all foods led to substantial increases in intake (P < 0.0001); for every 100 g added to the baseline portion, women in this group consumed an additional mean (±SEM) of 64 ± 12 g of food and 90 ± 19 kcal, until intake leveled off.",['women'],['Doggy bags and downsizing'],"['trajectory of intake across the weight of food served', 'portion size of all foods']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}]",,0.0196198,"In the Control Group, increasing the portion size of all foods led to substantial increases in intake (P < 0.0001); for every 100 g added to the baseline portion, women in this group consumed an additional mean (±SEM) of 64 ± 12 g of food and 90 ± 19 kcal, until intake leveled off.","[{'ForeName': 'Faris M', 'Initials': 'FM', 'LastName': 'Zuraikat', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Roe', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Alissa D', 'Initials': 'AD', 'LastName': 'Smethers', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA. Electronic address: bjr4@psu.edu.'}]",Appetite,['10.1016/j.appet.2018.07.009']
1322,32069288,Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.,"BACKGROUND


Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation.
METHODS AND FINDINGS


We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes.
CONCLUSIONS


In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted.
TRIAL REGISTRATION


The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.",2020,"Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life.","['Australia', 'Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation', 'people with mobility limitations admitted to aged care and neurological rehabilitation', '258 participants (129 intervention, 129 control', '3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation']","['intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices', 'secure online database (REDCap', 'average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge', 'usual multidisciplinary inpatient and post-hospital rehabilitation care']","['self-reported balance confidence and quality of life', 'upright time', 'adverse events', 'risk of a type I error; and potential low statistical power', 'Changes in mobility scores', 'mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1828349', 'cui_str': 'Using device'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1136005', 'cui_str': 'Computers, Handheld'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019728', 'cui_str': 'HLA-A'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034380'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.158428,"Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hassett', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maayken', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'McCluskey', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Department of Public & Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stuart T', 'Initials': 'ST', 'LastName': 'Smith', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Coffs Harbour, New South Wales, Australia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schurr', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Killington', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Bongers', 'Affiliation': 'Faculty of Design, Architecture and Building, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Treacy', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Dorsch', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Scrivener', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sakina', 'Initials': 'S', 'LastName': 'Chagpar', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pinheiro', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Heritier', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003029']
1323,31776655,Poly-ε-caprolactone scaffold for the reinforcement of stapled small intestinal anastomoses: a randomized experimental study.,"BACKGROUND


Anastomotic leakage is a severe complication in gastrointestinal surgery. Different methods have been evaluated for anastomotic reinforcement to prevent anastomotic leakage. The aim of this study was to investigate the effect of a poly-ε-caprolactone (PCL) scaffold incorporated in the staple-line, on the anastomotic strength and histological wound healing, of small intestinal anastomoses in piglets.
METHOD


This randomized experimental trial included 17 piglets. In each piglet, three end-to-end anastomoses were performed in the small intestine with a circular stapler, i.e. one control and two interventional anastomoses. On postoperative day 5, the anastomoses were resected and subjected to tension stretch test and histological examination.
RESULTS


No anastomotic leakage occurred. In the interventional anastomoses, the mean value for maximal tensile strength was 15.7 N, which was significantly higher than control anastomoses 12.7 N (p = 0.01). No statistically significant differences were found between the two groups in the histopathological parameters.
CONCLUSION


To conclude, this study has shown that the incorporation of a PCL scaffold in the staple-line was feasible and significantly increased the maximal tensile strength of small intestine anastomoses in piglets on postoperative day 5. The difference in histological parameters was not significantly distinct.",2019,"No statistically significant differences were found between the two groups in the histopathological parameters.
","['17 piglets', 'stapled small intestinal anastomoses', 'piglets']","['poly-ε-caprolactone (PCL) scaffold', 'Poly-ε-caprolactone scaffold']","['maximal tensile strength of small intestine anastomoses', 'anastomotic leakage', 'histological parameters', 'histopathological parameters', 'mean value for maximal tensile strength']","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0852831', 'cui_str': 'Small intestinal anastomosis'}]","[{'cui': 'C0908527', 'cui_str': 'caprolactone'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1540845', 'cui_str': 'Muscle tensile strength, function (observable entity)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0592161,"No statistically significant differences were found between the two groups in the histopathological parameters.
","[{'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Larsen', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Westerholt', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Madsen', 'Affiliation': 'Research Unit for Pathology, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'D Q S', 'Initials': 'DQS', 'LastName': 'Le', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, 8200, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Qvist', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, University of Southern Denmark, Odense, Denmark. famqvist@dadlnet.dk.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Ellebæk', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}]",Langenbeck's archives of surgery,['10.1007/s00423-019-01843-5']
1324,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND


Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS


We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
CONCLUSIONS


After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638']
1325,31322037,Effects of Social Support and 12-Step Involvement on Recovery among People in Continuing Care for Cocaine Dependence.,"Background:  Social networks that support recovery lead to enhanced treatment outcomes and sobriety regardless if this support stems from family, peer groups or 12-Step programs. Treatment process factors including readiness to change and commitment to abstinence also impact substance use. However, little is understood about the relationship between social support to treatment process factors during and after treatment for substance use disorders.  Objectives:  To identify the ways in which different social networks foster substance use change in a sample of individuals with cocaine dependence from intensive outpatient programs (IOPs).  Methods:  Data were drawn from two studies examining adults ( N  = 489) with cocaine dependence in IOPs for substance use disorders collected between 2004 and 2009. Assessment data were collected at 3- to 6-month intervals from baseline to 24-months and included the University of Rhode Island change assessment questionnaire, timeline followback, thoughts about abstinence, perceived social support - friend, and family versions and analyzed using GEE and mediational analyses.  Results:  Greater perceived friend social support was associated with greater readiness to change whereas greater perceived familial social support was associated with substance use goal; greater social support from both friends and family were associated with less substance use. Greater AA/NA participation was associated with substance use goal and readiness to change, and less substance use. Substance use goals partially mediated the impact of social support on later substance use.  Conclusions/Importance:  While peer and familial support are key to sustained recovery, their impact differentially affects treatment process variables. This information could be used to inform social support treatment interventions.",2019,Greater perceived friend social support was associated with greater readiness to change whereas greater perceived familial social support was associated with substance use goal; greater social support from both friends and family were associated with less substance use.,"['People in Continuing Care for Cocaine Dependence', 'individuals with cocaine dependence from intensive outpatient programs (IOPs', 'Methods:  Data were drawn from two studies examining adults ( N \u2009=\u2009489) with cocaine dependence in IOPs for substance use disorders collected between 2004 and 2009']",['Social Support and 12-Step Involvement'],"['University of Rhode Island change assessment questionnaire, timeline followback, thoughts about abstinence, perceived social support - friend, and family versions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0600427', 'cui_str': 'Cocaine dependence'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.0235709,Greater perceived friend social support was associated with greater readiness to change whereas greater perceived familial social support was associated with substance use goal; greater social support from both friends and family were associated with less substance use.,"[{'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Lookatch', 'Affiliation': 'Veterans Integrated Service Network 4, Mental Illness Research, Education and Clinical Center Michael J. Crescenz VA Medical Center , Philadelphia , PA , USA.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Wimberly', 'Affiliation': 'UM School of Social Work, University of Maryland, Baltimore , Baltimore , MA , USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McKay', 'Affiliation': 'Veterans Integrated Service Network 4, Mental Illness Research, Education and Clinical Center Michael J. Crescenz VA Medical Center , Philadelphia , PA , USA.'}]",Substance use & misuse,['10.1080/10826084.2019.1638406']
1326,31539833,Making the worst of a good job: Induced dampening appraisals blunt happiness and increase sadness in adolescents during pleasant memory recall.,"Previous work has shown that dampening appraisals (e.g., thinking ""this is too good to last"") reduce happiness and enhance sadness when adults recall positive events. In contrast, amplifying appraisals (e.g., thinking ""this is the sign of good things to come"") do not significantly alter affective experience during the same task. The present study examined whether this pattern holds in adolescence. Eighty-nine adolescents completed an uninstructed positive recall task before being randomized to either dampening, uninstructed control or amplifying instructions during a second positive recall task. Participants experienced a significantly smaller increase in happiness and a significantly less marked reduction in sadness when recalling a positive memory under dampening instructions, relative to both the amplifying and no instruction control conditions. There was no significant difference between the amplifying and control conditions. This broadly replicates adult findings, but the detrimental effects of dampening were less marked in adolescents than adults. Nevertheless, given that elevated dampening appraisals are associated with depressed mood, dampening may partly account for why depressed adolescents struggle to experience positive emotions, and represent a promising target for clinical intervention.",2019,"Participants experienced a significantly smaller increase in happiness and a significantly less marked reduction in sadness when recalling a positive memory under dampening instructions, relative to both the amplifying and no instruction control conditions.","['adolescents than adults', 'Eighty-nine adolescents completed an uninstructed positive recall task before being randomized to either']","['dampening, uninstructed control or amplifying instructions during a second positive recall task']",['happiness'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0018592', 'cui_str': 'Happinesses'}]",89.0,0.0203546,"Participants experienced a significantly smaller increase in happiness and a significantly less marked reduction in sadness when recalling a positive memory under dampening instructions, relative to both the amplifying and no instruction control conditions.","[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Mood Disorders Centre, School of Psychology, University of Exeter, Exeter, EX4 4QG, UK. Electronic address: my278@exeter.ac.uk.'}, {'ForeName': 'Lamprini', 'Initials': 'L', 'LastName': 'Psychogiou', 'Affiliation': 'Mood Disorders Centre, School of Psychology, University of Exeter, Exeter, EX4 4QG, UK.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Javaid', 'Affiliation': 'Mood Disorders Centre, School of Psychology, University of Exeter, Exeter, EX4 4QG, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': ""University of Exeter Medical School, University of Exeter, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.""}, {'ForeName': 'Barnaby D', 'Initials': 'BD', 'LastName': 'Dunn', 'Affiliation': 'Mood Disorders Centre, School of Psychology, University of Exeter, Exeter, EX4 4QG, UK.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103476']
1327,32492302,"Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children.","BACKGROUND


Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin's lymphoma are limited.
METHODS


We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B (LMB) chemotherapy with standard LMB chemotherapy alone. The primary end point was event-free survival. Overall survival and toxic effects were also assessed.
RESULTS


Analyses were based on 328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma. The median follow-up was 39.9 months. Events were observed in 10 patients in the rituximab-chemotherapy group and in 28 in the chemotherapy group. Event-free survival at 3 years was 93.9% (95% confidence interval [CI], 89.1 to 96.7) in the rituximab-chemotherapy group and 82.3% (95% CI, 75.7 to 87.5) in the chemotherapy group (hazard ratio for primary refractory disease or first occurrence of progression, relapse after response, death from any cause, or second cancer, 0.32; 95% CI, 0.15 to 0.66; one-sided P = 0.00096, which reached the significance level required for this analysis). Eight patients in the rituximab-chemotherapy group died (4 deaths were disease-related, 3 were treatment-related, and 1 was from a second cancer), as did 20 in the chemotherapy group (17 deaths were disease-related, and 3 were treatment-related) (hazard ratio, 0.36; 95% CI, 0.16 to 0.82). The incidence of acute adverse events of grade 4 or higher after prephase treatment was 33.3% in the rituximab-chemotherapy group and 24.2% in the chemotherapy group (P = 0.07); events were related mainly to febrile neutropenia and infection. Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
CONCLUSIONS


Rituximab added to standard LMB chemotherapy markedly prolonged event-free survival and overall survival among children and adolescents with high-grade, high-risk, mature B-cell non-Hodgkin's lymphoma and was associated with a higher incidence of hypogammaglobulinemia and, potentially, more episodes of infection. (Funded by the Clinical Research Hospital Program of the French Ministry of Health and others; ClinicalTrials.gov number, NCT01516580.).",2020,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","['adults with B-cell cancer', ""children with high-grade, mature B-cell non-Hodgkin's lymphoma"", ""328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma"", ""High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children"", ""patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B ""]","['standard LMB chemotherapy', 'Rituximab', 'LMB) chemotherapy with standard LMB chemotherapy alone', 'rituximab-chemotherapy']","['Event-free survival', 'efficacy and safety', 'incidence of acute adverse events', 'febrile neutropenia and infection', 'prolonged event-free survival and overall survival', 'event-free survival', 'Overall survival and toxic effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",328.0,0.163524,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pillon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'G A Amos', 'Initials': 'GAA', 'LastName': 'Burke', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Delgado', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Zsiros', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Csoka', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Bernarda', 'Initials': 'B', 'LastName': 'Kazanowska', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Chiang', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Adamson', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patte', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915315']
1328,32492577,Associations Between Food Insecurity and Parental Feeding Behaviors of Toddlers.,"OBJECTIVE


We examined associations between household food insecurity status and parental feeding behavior, weight perception, and child weight status in a diverse sample of young children.
METHODS


Cross-sectional analysis of 2-year-old children in Greenlight, a cluster randomized trial to prevent childhood obesity. The exposure was food insecurity, defined as a positive response to a validated screen. Outcomes were parent feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status. t tests and linear regression were used to assess associations between food insecurity and each outcome. We adjusted for child sex, race/ethnicity, parent education, employment, site, number of children in the home, and Special Supplemental Nutrition Program for Women, Infants, and Children status.
RESULTS


Five hundred three households (37%) were food insecure. After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, P = .01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; P = .02). No differences were observed in monitoring or restrictive feeding behaviors. After adjusting for covariates, there was no difference in weight status or prevalence of overweight/obesity of children or parents based on household food insecurity status.
CONCLUSIONS


Parents from food insecure households reported more pressuring feeding behaviors. This finding underscores the need to address food insecurity and potentially prevent harmful effects on child feeding. Parents in food insecure households might benefit from linkage with resources and education to develop healthier feeding behaviors.",2020,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","['503 households (37%) were food insecure', '2-year old children in Greenlight, a cluster randomized trial to prevent childhood obesity', 'Toddlers']",[],"['pressuring feeding behaviors', 'monitoring or restrictive feeding behaviors', 'weight status or prevalence of overweight/obesity', 'feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]",[],"[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",503.0,0.0299764,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","[{'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Orr', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel (CJ Orr and KB Flower), Chapel Hill, NC. Electronic address: colin_orr@med.unc.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ravanbakht', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine (S Ravanbakht and EM Perrin), Durham, NC.'}, {'ForeName': 'Kori B', 'Initials': 'KB', 'LastName': 'Flower', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel (CJ Orr and KB Flower), Chapel Hill, NC.'}, {'ForeName': 'H Shonna', 'Initials': 'HS', 'LastName': 'Yin', 'Affiliation': 'Department of Pediatrics and Department of Population Health, New York University School of Medicine (HS Yin) New York, NY.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Division of General and Internal Medicine, Department of Medicine, Vanderbilt University Medical Center (RL Rothman), Nashville, Tenn; Center for Health Services Research, Vanderbilt University Medical Center (RL Rothman), Nashville, Tenn.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Sanders', 'Affiliation': 'General Pediatrics, Department of Pediatrics, Stanford University of School of Medicine (LM Sanders), Stanford, Calif.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Delamater', 'Affiliation': 'Mailman Center for Child Development, University of Miami Miller School of Medicine (A Delamater), Miami, Fla.'}, {'ForeName': 'Eliana M', 'Initials': 'EM', 'LastName': 'Perrin', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine (S Ravanbakht and EM Perrin), Durham, NC.'}]",Academic pediatrics,['10.1016/j.acap.2020.05.020']
1329,32415575,"Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).","INTRODUCTION


Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks.
METHODS


In IXORA-S,  randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined.
RESULTS


Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16-20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE.
CONCLUSIONS


Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity.
TRIAL REGISTRATION


ClinicalTrials.gov identifier; NCT02561806.",2020,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"['patients with moderate-to-severe plaque psoriasis over 52\xa0weeks', 'Patients with plaque psoriasis often have nail psoriasis', 'nail psoriasis', 'Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis']","['IXE and UST (IXORA-S', 'IXE or UST', 'IXE', 'Ixekizumab', 'Ixekizumab (IXE) and ustekinumab (UST', 'UST']","['Psoriasis Area of Severity Index (PASI) and NAPSI improvement', 'nail psoriasis', 'NAPSI score improvement', 'baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI', 'Progressive improvement', 'skin response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}]",,0.0802576,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"[{'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wasel', 'Affiliation': 'Stratica Medical and Probity Medical Research, Edmonton, AB, Canada. nwasel@straticamedical.com.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Research Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'French', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University of Munich (LMU Munich), Munich, Germany.'}, {'ForeName': 'Curdin', 'Initials': 'C', 'LastName': 'Conrad', 'Affiliation': 'Department of Dermatology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dutronc', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Berggren', 'Affiliation': 'HaaPACS GmbH, Schriesheim, Germany.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, University Hospital of Nice-Côte d'Azur, Nice, France.""}]",Dermatology and therapy,['10.1007/s13555-020-00383-x']
1330,29169546,Telehealth electronic monitoring to reduce postdischarge complications and surgical site infections after arterial revascularization with groin incision.,"It is intuitive that postdischarge surgical complications are associated with increased patient dissatisfaction, and are directly associated with an increase in medical expenditures. It is also easy to make the connection that many post-hospital discharge surgical complications, including surgical site infections (SSIs), could be influenced or exacerbated by patient comorbidities. The authors of a recent study reported that female gender, obesity, diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive pulmonary disease, dyspnea, and neurologic disease were significant predictors of SSIs after vascular reconstruction was performed. The main concern for optimal patient care, especially in geographically isolated areas of West Virginia, is to have early, expeditious, and prompt diagnosis of complications and SSI. This adjunct to existing approaches could lead to improved outcomes and patient satisfaction, minimizing third-party interventions and decreasing the total cost of care. It seems reasonable to believe that monitoring using telehealth technology and managing the general health care of patients after a hospital vascular intervention will improve overall health and reduce 30-day readmissions and SSIs.",2017,"This adjunct to existing approaches could lead to improved outcomes and patient satisfaction, minimizing third-party interventions and decreasing the total cost of care.",['surgical site infections after arterial revascularization with groin incision'],['Telehealth electronic monitoring'],['total cost of care'],"[{'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0261742,"This adjunct to existing approaches could lead to improved outcomes and patient satisfaction, minimizing third-party interventions and decreasing the total cost of care.","[{'ForeName': 'Albeir Y', 'Initials': 'AY', 'LastName': 'Mousa', 'Affiliation': 'Department of Surgery, Robert C. Byrd Health Sciences Center/West Virginia University, Charleston Area Medical Center, Vascular Center of Excellence, Charleston, WVa. Electronic address: amousa@hsc.wvu.edu.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Broce', 'Affiliation': 'Center for Health Services and Outcomes Research, Charleston Area Medical Center Health Education and Research Institute, Charleston, WVa.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': 'Center for Health Services and Outcomes Research, Charleston Area Medical Center Health Education and Research Institute, Charleston, WVa.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McKee', 'Affiliation': 'Partners in Health Network Charleston, Charleston, WVa.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yacoub', 'Affiliation': 'Department of Surgery, Robert C. Byrd Health Sciences Center/West Virginia University, Charleston Area Medical Center, Vascular Center of Excellence, Charleston, WVa.'}]",Journal of vascular surgery,['10.1016/j.jvs.2017.07.063']
1331,27289488,"Low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy: Rationale and design of the Highlow study, a randomised trial of two doses.","BACKGROUND


Women with a history of venous thromboembolism (VTE) have a 2% to 10% absolute risk of VTE recurrence during subsequent pregnancies. Therefore, current guidelines recommend that all pregnant women with a history of VTE receive pharmacologic thromboprophylaxis. The optimal dose of low-molecular-weight heparin (LMWH) for thromboprophylaxis is unknown. In the Highlow study (NCT 01828697; www.highlowstudy.org), we compare a fixed low dose of LMWH with an intermediate dose of LMWH for the prevention of pregnancy-associated recurrent VTE. We present the rationale and design features of this study.
METHODS


The Highlow study is an investigator-initiated, multicentre, international, open-label, randomised trial. Pregnant women with a history of VTE and an indication for ante- and postpartum pharmacologic thromboprophylaxis are included before 14weeks of gestation. The primary efficacy outcome is symptomatic recurrent VTE during pregnancy and 6weeks postpartum. The primary safety outcomes are clinically relevant bleeding, blood transfusions before 6weeks postpartum and mortality. Patients are closely monitored to detect cutaneous reactions to LMWH and are followed for 3months after delivery. A central independent adjudication committee adjudicates all suspected outcome events.
CONCLUSION


The Highlow study is the first large randomised controlled trial in pregnancy that will provide high-quality evidence on the optimal dose of LWMH thromboprophylaxis for the prevention of recurrent VTE in pregnant women with a history of VTE.",2016,The optimal dose of low-molecular-weight heparin (LMWH) for thromboprophylaxis is unknown.,"['Pregnant women with a history of VTE and an indication for ante- and postpartum pharmacologic thromboprophylaxis are included before 14weeks of gestation', 'pregnant women with a history of VTE receive pharmacologic thromboprophylaxis', 'pregnant women with a history of VTE', 'pregnancy', 'Women with a history of venous thromboembolism (VTE']","['Low-molecular-weight heparin', 'LWMH thromboprophylaxis', 'LMWH with an intermediate dose of LMWH', 'low-molecular-weight heparin (LMWH']","['symptomatic recurrent VTE during pregnancy and 6weeks postpartum', 'clinically relevant bleeding, blood transfusions before 6weeks postpartum and mortality']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.141048,The optimal dose of low-molecular-weight heparin (LMWH) for thromboprophylaxis is unknown.,"[{'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Bleker', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: s.m.bleker@amc.uva.nl.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buchmüller', 'Affiliation': 'INSERM, CIC 1408 - F Crin, INNOVTE; CHU Saint-Etienne, Hôpital Nord, Service Médecine Vasculaire et Thérapeutique, F-42055 Saint Etienne, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chauleur', 'Affiliation': 'INSERM, U1059, F-42023, CHU Saint-Etienne, Hôpital Nord, Service de Gynéco-Obstétrique, F-42055 Saint Etienne, France.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Ní Áinle', 'Affiliation': 'Mater Misericordiae University Hospital and Rotunda Hospital, Dublin, Ireland; SPHERE Research Group, University College Dublin School of Medicine.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Donnelly', 'Affiliation': 'Mater Misericordiae University Hospital and Rotunda Hospital, Dublin, Ireland; SPHERE Research Group, University College Dublin School of Medicine.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'University Hospital Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium.'}, {'ForeName': 'Anne Flem', 'Initials': 'AF', 'LastName': 'Jacobsen', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Wessel', 'Initials': 'W', 'LastName': 'Ganzevoort', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prins', 'Affiliation': 'Department of Clinical Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Center for Vascular Diseases, Division ""Thrombosis Research"", University Hospital ""Carl Gustav Carus"", Dresden, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'DeSancho', 'Affiliation': 'Weill Cornell Medical Center New York, New York, United States.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Haemostasis, Johannes Gutenberg University of Mainz, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pabinger', 'Affiliation': 'Clinical Division of Haematology and Haemostaseology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Rodger', 'Affiliation': 'Departments of Medicine, Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada; Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Decousus', 'Affiliation': 'INSERM, CIC 1408 - F Crin, INNOVTE; CHU Saint-Etienne, Hôpital Nord, Service Médecine Vasculaire et Thérapeutique, F-42055 Saint Etienne, France.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Middeldorp', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}]",Thrombosis research,['10.1016/j.thromres.2016.06.001']
1332,32492705,Moderate-Intensity Exercise and High-Intensity Interval Training Affect Insulin Sensitivity Similarly in Obese Adults.,"OBJECTIVE


We compared the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on insulin sensitivity and other important metabolic adaptations in adults with obesity.
METHODS


Thirty-one inactive adults with obesity (age: 31 ± 6 years; body mass index: 33 ± 3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10 × 1-minute at 90%HRmax, 1-minute active recovery; n = 16) or MICT (45 minutes at 70%HRmax; n = 15). To assess the direct effects of exercise independent of weight/fat loss, participants were required to maintain body mass.
RESULTS


Training increased peak oxygen uptake by ~10% in both HIIT and MICT (P < 0.0001), and body weight/fat mass were unchanged. Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp) was ~20% greater the day after the final exercise session compared to pretraining (P < 0.01), with no difference between HIIT and MICT. When trained participants abstained from exercise for 4 days, insulin sensitivity returned to pretraining levels in both groups. HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism. Training-induced alterations in muscle lipid profile were also similar between groups.
CONCLUSION


Despite large differences in training intensity and exercise time, 12 weeks of HIIT and MICT induce similar acute improvements in peripheral insulin sensitivity the day after exercise, and similar longer term metabolic adaptations in skeletal muscle in adults with obesity. These findings support the notion that the insulin-sensitizing effects of both HIIT and MICT are mediated by factors stemming from the most recent exercise session(s) rather than adaptations that accrue with training.",2020,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"['adults with obesity', 'obese adults', 'Thirty-one inactive adults with obesity (age: 31±6 years, BMI: 33±3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10x1-minute at 90%HRmax, 1-minute active recovery; n=16) or']","['MICT', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT', 'HIIT and MICT', 'Moderate-intensity exercise and high-intensity interval training']","['muscle lipid profile', 'peak oxygen uptake', 'insulin sensitivity', 'Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp', 'body weight/fat mass']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",31.0,0.0721815,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Schleh', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Cheehoon', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Ludzki', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Varshney', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Van Pelt', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Chenevert', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Gioscia-Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Suzette M', 'Initials': 'SM', 'LastName': 'Howton', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rode', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Burant', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Horowitz', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa345']
1333,27280850,"Cost-effectiveness of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema Treatment: Analysis From the Diabetic Retinopathy Clinical Research Network Comparative Effectiveness Trial.","IMPORTANCE


Anti-vascular endothelial growth factor (VEGF) medicines have revolutionized diabetic macular edema (DME) treatment. A recent randomized clinical trial comparing anti-VEGF agents for patients with decreased vision from DME found that at 1 year aflibercept (2.0 mg) achieved better visual outcomes than repackaged (compounded) bevacizumab (1.25 mg) or ranibizumab (0.3 mg); the worse the starting vision, the greater the treatment benefit with aflibercept. However, aflibercept and ranibizumab, respectively, are approximately 31 and 20 times more expensive than bevacizumab.
OBJECTIVE


To examine the incremental cost-effectiveness ratios (ICERs) of aflibercept, bevacizumab, and ranibizumab for the treatment of DME.
DESIGN, SETTING, AND PARTICIPANTS


Post hoc analysis of efficacy, safety, and resource utilization data at 1-year follow-up from the Diabetic Retinopathy Clinical Research Network Comparative Effectiveness Trial. Patients were enrolled from August 22, 2012, through August 28, 2013, and analysis was performed from August 21, 2014, through November 7, 2015.
MAIN OUTCOMES AND MEASURES


The ICERs for all trial participants and subgroups with baseline vision of approximate Snellen equivalent 20/32 to 20/40 (better vision) and baseline vision of approximate Snellen equivalent 20/50 or worse (worse vision). One-year trial data were used to calculate cost-effectiveness for 1 year for the 3 anti-VEGF agents; mathematical modeling was then used to project 10-year cost-effectiveness results.
RESULTS


The study included 624 participants (mean [SD] age, 60.6 [10.5] years; 45.7% female; 65.5% white), 209 in the aflibercept group, 207 in the bevacizumab group, and 208 in the ranibizumab group. For all participants, during 1 year, the ICERs of aflibercept and ranibizumab compared with bevacizumab were $1 110 000 per quality-adjusted life-year (QALY) and $1 730 000 per QALY, respectively. During 10 years, they were $349 000 per QALY and $603 000 per QALY, respectively. Compared with ranibizumab, aflibercept's ICER was $648 000 per QALY at 1 year and $203 000 per QALY at 10 years. For the subgroup with worse baseline vision, the 10-year ICERs of aflibercept and ranibizumab compared with bevacizumab were $287 000 per QALY and $817 000 per QALY, respectively. In eyes with decreased vision from DME, treatment costs of aflibercept and ranibizumab would need to decrease by 69% and 80%, respectively, to reach a cost-effectiveness threshold of $100 000 per QALY compared with bevacizumab during a 10-year horizon; for the subgroup with worse baseline vision, the costs would need to decrease by 62% and 84%, respectively.
CONCLUSIONS AND RELEVANCE


Aflibercept (2.0 mg) and ranibizumab (0.3 mg) are not cost-effective relative to bevacizumab for treatment of DME unless their prices decrease substantially. These results highlight the challenges that physicians, patients, and policymakers face when safety and efficacy results are at odds with cost-effectiveness results.",2016,"During 10 years, they were $349 000 per QALY and $603 000 per QALY, respectively.","['624 participants (mean [SD] age, 60.6 [10.5] years; 45.7% female; 65.5% white), 209 in the aflibercept group, 207 in the bevacizumab group, and 208 in the ranibizumab group', 'trial participants and subgroups with baseline vision of approximate Snellen equivalent 20/32 to 20/40 (better vision) and baseline vision of approximate Snellen equivalent 20/50 or worse (worse vision', 'patients with decreased vision from DME found that at 1 year', 'Diabetic Macular Edema Treatment', 'Patients were enrolled from August 22, 2012, through August 28, 2013, and analysis was performed from August 21, 2014, through November 7, 2015']","['ranibizumab', 'Aflibercept, Bevacizumab, and Ranibizumab', 'anti-VEGF agents', 'bevacizumab', 'aflibercept, bevacizumab, and ranibizumab', 'aflibercept and ranibizumab', 'Anti-vascular endothelial growth factor (VEGF) medicines', ""ranibizumab, aflibercept's ICER"", 'aflibercept']","['visual outcomes', 'efficacy, safety, and resource utilization data', '10-year ICERs', 'incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0558171', 'cui_str': 'Decreased vision'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",624.0,0.15558,"During 10 years, they were $349 000 per QALY and $603 000 per QALY, respectively.","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Ross', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor2Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hutton', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor3Department of Industrial and Operations Engineering, University of Michigan College of Engineering, Ann Arbor4Institute for Healthcare Policy and Innovat.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Stein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor2Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor4Institute for Healthcare Policy and Innovation, Univers.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland6Editor, JAMA Ophthalmology.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2016.1669']
1334,27333620,[Efficacy and safety of high-dose dexamethasone combined with rhTPO for newly diagnosed adults   with severe immune thrombocytopenia].,"OBJECTIVE


To evaluate the efficacy and safety of high dose dexamethasone combined with recombinant human thrombopoietin (rhTPO) in adults with severe newly diagnosed immune thrombocytopenia (ITP).
METHODS


Forty-eight adult patients with severe ITP were randomized into two groups, experimental group and control group. The patients in experimental group were given high-dose dexamethasone combined with rhTPO treatment, the patients in control group were given single high-dose dexamethasone treatment. Platelet count, platelet increase, as well as the overall response rate were strictly observed in the process. At the same time, the patient's drug tolerance and any adverse drug reactions were observed.
RESULTS


The platelet counts and platelet increase of the patients in experimental group were significantly higher than that in control group (P<0.05) at day 3, 7, 14, 30. There was no significant difference in overall response rates between the two groups (34.8% vs 36.0%, 56.5% vs 48.0%, P>0.05) at day 3, 7. The overall response rates of experimental group at day 14, 30 were significantly higher than that of control group (91.3% vs 68.0%, 82.6% vs 52.0%, P<0.05). The muscle aches occurred in one patient in experimental group which was self-recovery without special treatment.
CONCLUSION


rhTPO combined with high-dose dexamethasone could rapidly increase the platelet count, reduce the risk of bleeding, and prolonge the effect with a low incidence of tolerable adverse events compared to single high-dose dexamethasone. rhTPO combined with high-dose dexamethasone could be a new therapeutic choice for severe primary ITP.",2016,"The platelet counts and platelet increase of the patients in experimental group were significantly higher than that in control group (P<0.05) at day 3, 7, 14, 30.","['Forty-eight adult patients with severe ITP', 'newly diagnosed adults   with severe immune thrombocytopenia', 'adults with severe newly diagnosed immune thrombocytopenia (ITP']","['dexamethasone', 'rhTPO combined with high-dose dexamethasone', 'dexamethasone treatment', 'dexamethasone combined with rhTPO', 'dexamethasone combined with recombinant human thrombopoietin (rhTPO']","['overall response rates', 'platelet count', 'platelet counts and platelet increase', 'efficacy and safety', 'Platelet count, platelet increase', ""patient's drug tolerance and any adverse drug reactions"", 'risk of bleeding', 'muscle aches', 'overall response rate']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021540', 'cui_str': 'ITP'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0857460', 'cui_str': 'Platelet count above reference range'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013220', 'cui_str': 'Drug Tolerance'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",48.0,0.0582829,"The platelet counts and platelet increase of the patients in experimental group were significantly higher than that in control group (P<0.05) at day 3, 7, 14, 30.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Muhebaier', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'An', 'Affiliation': ''}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,[]
1335,31296923,Association of post-operative CEA with survival and oxaliplatin benefit in patients with stage II colon cancer: a post hoc analysis of the MOSAIC trial.,"BACKGROUND


Adjuvant treatment for stage II colon cancer (CC) can be proposed to patients with high-risk disease. Recently, 2.35 ng/mL carcinoembryonic antigen (CEA) was identified as the best cut-off value. This post hoc analysis of the MOSAIC trial assessed post-operative CEA prognostic value for survival outcomes and predictive value for the addition of oxaliplatin to adjuvant treatment.
METHODS


Prognostic and predictive values of post-operative CEA in patients with stage II CC were evaluated with Kaplan-Meier survival curves and Cox model with interaction terms. Disease-free survival (DFS) and overall survival (OS) were estimated.
RESULTS


Among 899 stage II CC patients, post-operative CEA was available in 867 (96.4%); and 434 (48.65%) had a high-risk stage II disease. The 3-year DFS rate was 88.5% and 78.7% in the ≤ 2.35 ng/mL and > 2.35 ng/mL group, respectively (P = 0.006). Use of oxaliplatin showed survival benefit only in patients with high-risk stage II CC and post-operative CEA > 2.35 ng/ml (interaction term P = 0.09 and 0.03 for DFS and OS).
CONCLUSION


CEA is a strong prognostic factor for DFS and OS in stage II CC. In the MOSAIC trial, only high-risk stage II CC patients with post-operative CEA > 2.35 ng/mL benefited from the addition of oxaliplatin to LV5FU2.
TRIAL REGISTRATION


NCT00275210 (January 11, 2006).",2019,"Use of oxaliplatin showed survival benefit only in patients with high-risk stage II CC and post-operative CEA > 2.35 ng/ml (interaction term P = 0.09 and 0.03 for DFS and OS).
","['patients with high-risk disease', 'patients with stage II CC', 'patients with stage II colon cancer', 'stage II colon cancer (CC']","['oxaliplatin', 'CEA']","['3-year DFS rate', 'Disease-free survival (DFS) and overall survival (OS', 'post-operative CEA', 'survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",,0.250109,"Use of oxaliplatin showed survival benefit only in patients with high-risk stage II CC and post-operative CEA > 2.35 ng/ml (interaction term P = 0.09 and 0.03 for DFS and OS).
","[{'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Auclin', 'Affiliation': 'Department of Hepato-Gastroenterology and Gastrointestinal Oncology, Sorbonne Paris-Cité, Paris Descartes University, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Sorbonne University, Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Hepato-Gastroenterology and Gastrointestinal Oncology, Sorbonne Paris-Cité, Paris Descartes University, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Unit of Medical Oncology, Clinical Cancer Center, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'Department of Gastroenterology and Digestive diseases, Hopital Erasme, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), CIBERONC, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Department of Oncology, Royal Bournemouth Hospital and Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'Aimery', 'Initials': 'A', 'LastName': 'de Gramont', 'Affiliation': 'Oncology Multidisciplinary Research Group (GERCOR), Paris, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France. dvernerey@chu-besancon.fr.'}]",British journal of cancer,['10.1038/s41416-019-0521-7']
1336,32419491,Short- and Midterm Adherence to Platelet P2Y12 Receptor Inhibitors After Percutaneous Coronary Intervention With Drug-Eluting Stents.,"INTRODUCTION/OBJECTIVES


In patients who have undergone recent percutaneous coronary intervention (PCI), poor adhesion to antiplatelet agents may increase the risk of stent thrombosis and death. We aimed to investigate the adherence to different P2Y12 receptor inhibitors after PCI with drug-eluting stent in stable and unstable patients and to evaluate the factors associated with low adherence.
METHOD


In a prospective study conducted between 2014 and 2018, the 8-item Morisky scale was applied at 30 days and 6 months post-PCI to measure P2Y12 receptor inhibitors adherence. Also, we describe the characteristics of patients using different platelet receptor P2Y12 inhibitors. Regression models were used to identify predictors of poor adherence.
RESULTS


A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes). Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years,  P  < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years,  P  < .01). Patients with low/moderate adherence at 30 days and 6 months represented, respectively, 19.8% and 27.5% of our sample. Current smokers and preexisting cardiovascular disease at presentation were associated with lower adherence at 30 days.
CONCLUSIONS


We found substantial rates of moderate and low adherence to P2Y12 receptor inhibitors early after PCI. Current smokers and preexisting cardiovascular disease at presentation were associated with a lower likelihood of adherence. These results highlight the need of monitoring adherence to medical treatment after PCI.",2020,"Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years,  P  < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years,  P  < .01).","['A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes', 'patients who have undergone recent percutaneous coronary intervention (PCI']","['Percutaneous Coronary Intervention With Drug-Eluting Stents', 'Platelet P2Y12 Receptor Inhibitors', 'clopidogrel', 'ticagrelor']",['risk of stent thrombosis and death'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",214.0,0.0204004,"Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years,  P  < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years,  P  < .01).","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Morita', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Wajngarten', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Miguel Morita', 'Initials': 'MM', 'LastName': 'Fernandes-Silva', 'Affiliation': 'Department of Internal Medicine, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Caixeta', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Franken', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Antonio E', 'Initials': 'AE', 'LastName': 'Pesaro', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420926667']
1337,26823382,A Novel Feed-Forward Modeling System Leads to Sustained Improvements in Attention and Academic Performance.,"Objective:  This study tested a novel feed-forward modeling (FFM) system as a nonpharmacological intervention for the treatment of ADHD children and the training of cognitive skills that improve academic performance.  Method:  This study implemented a randomized, controlled, parallel design comparing this FFM with a nonpharmacological community care intervention. Improvements were measured on parent- and clinician-rated scales of ADHD symptomatology and on academic performance tests completed by the participant. Participants were followed for 3 months after training.  Results:  Participants in the FFM training group showed significant improvements in ADHD symptomatology and academic performance, while the control group did not. Improvements from FFM were sustained 3 months later.  Conclusion:  The FFM appeared to be an effective intervention for the treatment of ADHD and improving academic performance. This FFM training intervention shows promise as a first-line treatment for ADHD while improving academic performance.",2020,"RESULTS


Participants in the FFM training group showed significant improvements in ADHD symptomatology and academic performance, while the control group did not.",['ADHD children'],"['novel feed-forward modeling (FFM) system', 'FFM', 'FFM training']","['parent- and clinician-rated scales of ADHD symptomatology and on academic performance tests', 'ADHD symptomatology and academic performance']","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0222045'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.01961,"RESULTS


Participants in the FFM training group showed significant improvements in ADHD symptomatology and academic performance, while the control group did not.","[{'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'McDermott', 'Affiliation': 'Atentiv LLC, Waltham, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Rose', 'Affiliation': 'Atentiv LLC, Waltham, MA, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Norris', 'Affiliation': 'Atentiv LLC, Waltham, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gordon', 'Affiliation': 'Atentiv LLC, Waltham, MA, USA.'}]",Journal of attention disorders,['10.1177/1087054715623044']
1338,31560971,Acceptability and Efficacy of a Sexual Health Texting Intervention Designed to Support Adolescent Females.,"OBJECTIVE


To evaluate the feasibility, acceptability, and initial efficacy of a pilot texting intervention (""t4she"") in primary care designed to increase sexual health knowledge and promote dual protection strategies to reduce unintended pregnancies and sexually transmitted infections among adolescent females.
METHODS


Participants were recruited from 2 federally qualified health centers. Eligibility included: being 13 to 18 years of age; assigned female at birth; English-speaking; not currently pregnant and/or intending to become pregnant; and having texting capabilities. A randomized controlled trial assessed between-group differences at 3 and 6 months on knowledge, Health Belief Model constructs, and sexual behaviors. Input on intervention acceptability was obtained at 3 months.
RESULTS


Among 244 participants enrolled and randomized, the average age was 16 (±1.6), 80% were Hispanic/Latina, 53% had ever had vaginal sex, and 50% had used prescription birth control with 24% currently using a long-acting reversible method. Among those sexually active, 29% reported consistent condom use and 24% reported engaging in dual protection behaviors at last sex. Among participants with all follow-up data (N = 136), intervention participants had significant increases in sexual health knowledge and reported more prescription birth control use at follow-up than control participants. No significant outcome differences were found for condom use or dual protection behaviors. Intervention participants reported receiving messages, being introduced to new information, and reading and sharing the messages.
CONCLUSIONS


The pilot t4she sexual health intervention significantly improved knowledge and use of short-acting prescription birth control among young females in primary care and was acceptable by youth and feasible to implement.",2020,The pilot t4she sexual health intervention significantly improved knowledge and use of short-acting prescription birth control among young females in primary care and was acceptable by youth and feasible to implement.,"['support adolescent females', 'Participants were recruited from 2 federally qualified health centers', 'adolescent females', 'young females in primary care', 'Eligibility included: being 13-18 years of age; assigned female at birth; English-speaking; not currently pregnant and/or intending to become pregnant; and having texting capabilities', '244 participants enrolled and randomized, the average age was 16 (±1.6), 80% were Hispanic/Latina, 53% had ever had vaginal sex, and 50% had used prescription birth control with 24% currently using a long-acting reversible method']","['pilot texting intervention (""t4she', 'sexual health texting intervention']","['sexual health knowledge', 'prescription birth control use', 'dual protection behaviors', 'Acceptability and efficacy', 'knowledge, Health Belief Model constructs, and sexual behaviors', 'feasibility, acceptability and initial efficacy', 'condom use or dual protection behaviors']","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444864', 'cui_str': 'AM 13 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}]",244.0,0.0454064,The pilot t4she sexual health intervention significantly improved knowledge and use of short-acting prescription birth control among young females in primary care and was acceptable by youth and feasible to implement.,"[{'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Rinehart', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo; Department of Medicine, University of Colorado, School of Medicine (DJ Rinehart, EP Havranek, and M Cox-Martin), Aurora, Colo. Electronic address: deborah.rinehart@dhha.org.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Leslie', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo.'}, {'ForeName': 'M Joshua', 'Initials': 'MJ', 'LastName': 'Durfee', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Stowell', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cox-Martin', 'Affiliation': 'Department of Medicine, University of Colorado, School of Medicine (DJ Rinehart, EP Havranek, and M Cox-Martin), Aurora, Colo.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Thomas-Gale', 'Affiliation': 'Ambulatory Care Services, Denver Health and Hospital Authority (T Thomas-Gale), Denver, Colo.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Shlay', 'Affiliation': 'Denver Public Health, Denver Health and Hospital Authority (JC Shlay), Denver, Colo; Department of Family Medicine, School of Medicine, University of Colorado Anschutz Medical Campus (JC Shlay), Aurora, Colo.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Havranek', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo; Department of Medicine, University of Colorado, School of Medicine (DJ Rinehart, EP Havranek, and M Cox-Martin), Aurora, Colo.'}]",Academic pediatrics,['10.1016/j.acap.2019.09.004']
1339,32416333,Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design.,"Atrial fibrillation is the most common sustained arrhythmia affecting over 33 million people worldwide. Approximately 70% of AF patients have non-paroxysmal AF. As AF progresses from paroxysmal to non-paroxysmal forms, the prevalence of comorbidities increases. The efficacy of catheter ablation for persistent and long standing persistent (LSP) AF is <40%, often requiring multiple ablation procedures with greater cost and potentially more complications. There is an unmet need to effectively treat such patients. METHODS: CONVERGE is an investigational device exempt, prospective, multi-center, open label 2:1 randomized controlled pivotal study to evaluate the overall success of the Convergent hybrid procedure compared to endocardial catheter ablation for the treatment of symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD). A total of 153 subjects at 27 centers are treated in the study. The CONVERGE study is differentiated from other studies currently being conducted on the persistent AF population, because a) there is no time restriction on the duration of diagnosed AF in the patients being studied and b) the trial allows patients with left atrial sizes up to 6 centimeters. The ongoing trials are limited to either 6 months, 12 months or 3-years of continuous AF making CONVERGE the only ablation trial thus far to include a substantial portion of patients with longstanding persistent AF. The convergent procedure involves combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation. The primary endpoint is freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The primary safety endpoint is the incidence of major adverse events from the procedure through 30-days post procedure. CONCLUSION: CONVERGE AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF. By providing objective comparative data, the study aims to provide guidance on the treatment of such patients.",2020,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"['symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD', '153 subjects at 27 centers are treated in the study', 'patients with longstanding persistent AF', 'patients with left atrial sizes up to 6 centimeters']","['minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation', 'catheter ablation', 'Epicardial and Endocardial RF Ablation', 'endocardial catheter ablation']","['freedom from AF/AFL/AF absent class I/III AAD', 'incidence of major adverse events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0475210', 'cui_str': 'cm'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0014124', 'cui_str': 'Endocardial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",153.0,0.021211,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'DeLurgio', 'Affiliation': ""Emory St. Joseph's Hospital, Atlanta, GA.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}, {'ForeName': 'Jaswinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blauth', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Saumil', 'Initials': 'S', 'LastName': 'Oza', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mostovych', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Yashasvi', 'Initials': 'Y', 'LastName': 'Awasthi', 'Affiliation': 'AtriCure, Inc., Mason, OH. Electronic address: yawasthi@atricure.com.'}, {'ForeName': 'Nfii', 'Initials': 'N', 'LastName': 'Ndikintum', 'Affiliation': 'AtriCure, Inc., Mason, OH.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Crossen', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}]",American heart journal,['10.1016/j.ahj.2020.02.016']
1340,32416385,Transdiagnostic preventative intervention for subclinical anxiety: Development and initial validation.,"Risk factors associated with the development of anxiety disorders have been identified; however, the development of preventive interventions targeting these risk factors is in the nascent stage. To date, preventive interventions have tended to target specific anxiety disorder symptoms (e.g., panic attacks). Although these interventions are effective at reducing risk for the targeted disorder (e.g., panic disorder), the focus of the intervention is narrow, thereby limiting the dissemination of these interventions. One approach that may broaden the scope of our prevention efforts is the development of a transdiagnostic intervention. Currently, transdiagnostic interventions have only been used in those with diagnosed conditions (e.g., anxiety disorders); however, it stands to reason that a transdiagnostic approach may also be helpful for those at-risk for developing anxiety disorders. The present study reported on the development and use of a brief preventative intervention for those with subclinical anxiety (i.e., worry, social anxiety). Participants were randomized into either a transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group. Participants consisted of sixty-nine individuals with subclinical levels of anxiety. Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group. Further, change in safety aid utilization was a significant mediator in the association between intervention group and social anxiety and worry at Week 1; however, it was not a significant mediator at Month 1. Implications of these results and avenues for future research are discussed.",2020,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.",['Participants consisted of sixty-nine individuals with subclinical levels of anxiety'],"['transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group', 'Transdiagnostic preventative intervention']","['safety aid utilization', 'social anxiety, worry, and levels of impairment', 'social anxiety and worry']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",69.0,0.0158088,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.","[{'ForeName': 'Kristina J', 'Initials': 'KJ', 'LastName': 'Korte', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA; Harvard T.H. Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: kkorte@mgh.harvard.edu.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.001']
1341,31383238,"Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.","STUDY OBJECTIVES


Insomnia is a chief complaint among postmenopausal women, and insomnia impairs daytime functioning and reduces quality of life. Recent evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI) for menopausal insomnia, but it remains unclear whether treating insomnia improves daytime function in this population. This study evaluated whether CBTI improves daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life in postmenopausal women with insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious.
METHODS


Single-site, randomized control trial. One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia were randomized to 3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at pretreatment, posttreatment, and 6-month follow-up.
RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later. The CBTI group reported better quality of life as indicated by substantial improvements in emotional wellbeing and resiliency to physical and emotional problems, whereas the SRT and SHE groups only showed improvements in resiliency to physical problems. Pain complaints decreased as sleep improved but were not associated with specific treatment conditions. Similarly, insomnia remitters reported fewer daytime and nighttime hot flashes, although reductions were not associated with any specific treatment.
CONCLUSIONS


CBTI and SRT are efficacious options for postmenopausal women with chronic insomnia. Both interventions improve daytime function, quality of life, and work performance, although CBTI produces superior results including the added benefit of improved emotional health.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295; URL: https://clinicaltrials.gov/ct2/show/record/NCT01933295.",2019,"RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later.","['postmenopausal women with chronic insomnia', 'One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia', 'postmenopausal women with insomnia', 'Postmenopausal Women With Insomnia']","['3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI', 'Cognitive Behavioral Therapy', 'CBTI and SRT', 'sleep restriction therapy (SRT)-a single component of CBTI', 'CBTI', 'cognitive behavioral therapy']","['daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life', 'Pain complaints', 'daytime and nighttime hot flashes', 'daytime function, quality of life, and work performance', 'Improving Daytime Functioning, Work Performance, and Quality of Life', 'emotional wellbeing and resiliency to physical and emotional problems', 'quality of life', 'fatigue, energy, sleepiness, and work function', 'Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1286385', 'cui_str': 'Performance at Work'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",150.0,0.064667,"RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Atkinson', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Roehrs', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7882']
1342,31559463,Acute ACL reconstruction shows superior clinical results and can be performed safely without an increased risk of developing arthrofibrosis.,"PURPOSE


To compare acute ACL reconstruction (ACLR) within 8 days of injury with delayed reconstruction after normalized range of motion (ROM), 6-10 weeks after injury. It was hypothesized that acute ACL reconstruction with modern techniques is safe and can be beneficial in terms of patient-reported outcomes and range of motion.
METHODS


The effect of acute and delayed ACLR was randomized studied on 70 patients with high recreational activity level, Tegner level 6 or more, between 2006 and 2013. Patient-reported outcomes, objective IKDC, KOOS, and manual stability measurements were documented during the 24-month follow-up period.
RESULTS


The acute ACLR group did not result in increased stiffness and showed superior outcome regarding strength and how the patient felt their knee functioning at 24 months. In addition, the acute group was not inferior to the delayed group in any assessment. Regarding patient-related outcomes in KOOS, both groups showed significant improvements in all subscales, but no difference was found between the groups. Functional return (FR) rate was almost double compared to the Swedish knee ligament register and treatment failure (TF) rate was reduced by half, no significant difference between the groups. No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
CONCLUSION


Acute ACLR within 8 days of injury does not appear to adversely affect ROM or result in increased stiffness in the knee joint and was not inferior to the delayed group in any assessment when compared to delayed surgery.
LEVEL OF EVIDENCE


I.",2020,"No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
","['70 patients with high recreational activity level, Tegner level 6 or more, between 2006 and 2013']",['acute ACL reconstruction (ACLR'],"['Functional return (FR) rate', 'Swedish knee ligament register and treatment failure (TF) rate', 'cyclops removal, re-injury of ACL or meniscus', 'objective IKDC, KOOS, and manual stability measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0162643'}, {'cui': 'C1578615', 'cui_str': 'Cyclops'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2315938', 'cui_str': 'Genus Meniscus'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.053596,"No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'von Essen', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden. Christoffer.vonessen@gmail.com.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Barenius', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05722-w']
1343,31551577,Transcutaneous electric nerve stimulation to treat patients with premature ejaculation: phase II clinical trial.,"A phase II single-arm trial was conducted from June 2017 to October 2018 to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for premature ejaculation (PE) treatment. Twelve men with PE and no prior treatment were enrolled, one was withdrawn and 11 subjects provided data for the main outcome. TPTNS consisted of 30-min sessions of the application of 20 Hz with a pulse amplitude of 200 µsec. The intensity was adjusted based on individual sensibility. The participants received 3 weekly sessions for 12 consecutive weeks. Follow-up continued for 9 months after therapy completion. The main outcome was a threefold increase in the intravaginal ejaculation latency time (IELT) at week 12. Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12. The IELT increased 4.8-fold, 6.8-fold, and 5.4-fold at weeks 12, 24, and 48, respectively. One episode of constipation was reported, and one patient reported a sensation of heat in the leg during one therapy session. The findings suggest that TPTNS therapy delays ejaculation in patients with lifelong premature ejaculation, with no serious secondary effects. Controlled trials with larger sample sizes are needed to verify these results.",2020,"Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12.","['patients with lifelong premature ejaculation', 'Twelve men with PE and no prior treatment were enrolled, one was withdrawn and 11 subjects provided data for the main outcome', 'premature ejaculation (PE) treatment', 'patients with premature ejaculation']","['Transcutaneous electric nerve stimulation', 'transcutaneous posterior tibial nerve stimulation (TPTNS']","['intravaginal ejaculation latency time (IELT', 'tripled baseline IELT scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0410765,"Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12.","[{'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Uribe', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sandoval-Salinas', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'Hector A', 'Initials': 'HA', 'LastName': 'Corredor', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Martínez', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Saffon', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia. jsaffon@bostonmedical.com.co.'}]",International journal of impotence research,['10.1038/s41443-019-0196-x']
1344,26470422,[EFFECT OF LONGIDAZE ON MICROBIAL LANDSCAPE OF CERVICAL CANAL AND UTERINE CAVITY DURING THERAPY OF WOMEN WITH CHRONIC NONSPECIFIC ENDOMETRITIS AND UTERUS MYOMA].,"AIM


Evaluation of microbiological effectiveness of longidaze preparation use during therapy of active non-specific endometritis in women with uterus myoma.
MATERIALS AND METHODS


2 groups of women were formed by a method of random selection. The first was composed of patients with active chronic endometritis, that had received standard etiotropic antibacterial therapy. The second included patients, that had received longidaze in addition to the standard therapy. Therapy effectiveness evaluation was carried out based on the analysis of microbial landscape of cervical canal and uterine cavity 2 months after the therapy during phase I of the menstrual cycle.
RESULTS


Non-plasma-coagulating staphylococci, enterococci and anaerobes were established to be present predominately in the examined women of both the first and the second group.
CONCLUSION


The application of longidaze in combination with antibacterial therapy results in the most significant improvement of microbial landscape of cervical canal and uterine cavity.",2015,The application of longidaze in combination with antibacterial therapy results in the most significant improvement of microbial landscape of cervical canal and uterine cavity.,"['THERAPY OF WOMEN WITH CHRONIC NONSPECIFIC ENDOMETRITIS AND UTERUS MYOMA', '2 groups of women were formed by a method of random selection', 'patients with active chronic endometritis', 'women with uterus myoma']","['longidaze preparation', 'standard etiotropic antibacterial therapy']",['microbial landscape of cervical canal and uterine cavity'],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0238104', 'cui_str': 'Chronic endometritis (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0227841', 'cui_str': 'Cervical canal structure (body structure)'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}]",,0.0460663,The application of longidaze in combination with antibacterial therapy results in the most significant improvement of microbial landscape of cervical canal and uterine cavity.,"[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Troshina', 'Affiliation': ''}, {'ForeName': 'I I', 'Initials': 'II', 'LastName': 'Dolgushin', 'Affiliation': ''}, {'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Dolgushina', 'Affiliation': ''}, {'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Bakhareva', 'Affiliation': ''}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Kurnosenko', 'Affiliation': ''}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Nadvikova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1345,26470430,[TREATMENT OF PATIENTS WITH CHRONIC RECURRENT HERPES VIRUS INFECTION OF GENITAL LOCALIZATION: A CLINICAL STUDY OF FORTEPREN PREPARATION].,"AIM


Selection of optimal dosage regimen, length of treatment course (frequency of administration), safety, tolerance and clinical effectiveness evaluation of the medical preparation fortepren in patients with chronical recurrent herpes virus infection of genital localization.
MATERIALS AND METHODS


The medical product of antiviral and immune modulating effect--fortepren (sodium polyprenyl phosphate) as a 4 mg/ml solution for injections combined with the base course of acyclic nucleoside acyclovir, 400 mg tablets, held studies. 40 male and female patients participated in the study. After a 10-day acyclovir course (400 mg x 3 times a day) for removing the acute phase, 4 groups of 10 individuals were formed: 1--5 ml (20 mg) of fortepren i/m once at day 13 ± 2 after the start of the study after the completion of the treatment of the acute phase of the disease; 2--5 ml (20 mg) fortepren i/m 3 times at an interval of 21 days; 3--2 ml (8 mg) fortepren i/m 3 times at an interval of 21 days; 4 (control)--5 ml of placebo i/m at remission stage 3 times at an interval of 21 days. Increase of the duration of inter-recurrence period, decrease of the severity of the recurrences, state of skin and mucous damage elements, improvements of immunologic parameters were considered during effectiveness evaluation.
RESULTS


Significant differences in the frequency of recurrences of genital herpes were shown for 3 months of observation in experimental and control groups. A significant reduction of genital herpes recurrence frequency from 3.52 ± 0.09 (before treatment) to 2.89 ± 0.08 (after treatment) was noted in patients of group 3 (p < 0.001). The frequency of recurrences in the control group was 3.84 ± 0.10, that was higher than the parameters in all the experimental groups. A significant reduction of the rash area was noted in group 3, moreover, a redution of frequency of detection of clinical manifestations of genital herpes in the form of vesicle elements after treatment in groups 2 (p = 0.02) and 3 (p = 0.005) was found. Evaluation of local symptoms has established that burning have caused minimal discomfort for patients of groups 3 and 4 and itch and soreness--of groups 1 and 3. The least pronounced exacerbations were noted in patients of group 3. Intramuscular administration of fortepren preparation was established to result in the increase of titers of leukocyte virus-induced interferon for the whole duration of treatment.
CONCLUSION


An intramuscular dose of 2 ml (8 mg) at recurrence stage 3 times at an interval of 21 days after the completion of the 10-day base course of treatment of the acute phase of chronical recurrent herpes virus infection of genital localization using acyclovir was accepted as an optimal dosage regimen. Analysis of the obtained results has shown an acceptable safety profile and a good level of tolerance for fortepren preparation.",2015,"RESULTS


Significant differences in the frequency of recurrences of genital herpes were shown for 3 months of observation in experimental and control groups.","['patients with chronical recurrent herpes virus infection of genital localization', '40 male and female patients participated in the study']","['acyclovir', 'fortepren (sodium polyprenyl phosphate', 'placebo']","['redution of frequency of detection of clinical manifestations of genital herpes', 'genital herpes recurrence frequency', 'frequency of recurrences of genital herpes', 'frequency of recurrences', 'severity of the recurrences, state of skin and mucous damage elements, improvements of immunologic parameters', 'titers of leukocyte virus-induced interferon', 'safety, tolerance and clinical effectiveness evaluation', 'rash area']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019372', 'cui_str': 'Herpesvirus Infections'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1280464', 'cui_str': 'Manifestation of (qualifier value)'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439708', 'cui_str': 'Mucous (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",40.0,0.0476492,"RESULTS


Significant differences in the frequency of recurrences of genital herpes were shown for 3 months of observation in experimental and control groups.","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Narovlyansky', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Sedov', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Pronin', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Shulzhenko', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sanin', 'Affiliation': ''}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Zuikova', 'Affiliation': ''}, {'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Schubelko', 'Affiliation': ''}, {'ForeName': 'A Yu', 'Initials': 'AY', 'LastName': 'Savchenko', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Parfenova', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Izmestieva', 'Affiliation': ''}, {'ForeName': 'An V', 'Initials': 'AV', 'LastName': 'Izmestieva', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Grigorieva', 'Affiliation': ''}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Suprun', 'Affiliation': ''}, {'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Zubashev', 'Affiliation': ''}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Kozlov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1346,30624616,Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER2-positive metastatic breast cancer.,,2019,,['HER2-positive metastatic breast cancer'],"['nonpegylated liposomal doxorubicin', 'trastuzumab and paclitaxel']",[],"[{'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}]","[{'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]",[],,0.0146698,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manikhas', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Llombart', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Roman', 'Affiliation': ''}, {'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Semiglazov', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Byakhov', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lokanatha', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Forenza', 'Affiliation': ''}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Goldfarb', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Matera', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Azarnia', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rozencweig', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy529']
1347,26554558,Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial.,"BACKGROUND


Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs - it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established.
METHODS/DESIGN


AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events.
DISCUSSION


The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU.
TRIAL REGISTRATION


The study is registered on a public database with clinicaltrials.gov ( NCT02333123 ; registered on 5 November 2014).",2015,"Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established.
","['100 participants, identified from community leg ulcer clinics and hospital clinics', 'patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU', 'Venous Ulcers', '100 adults']","['standard care with compression therapy', 'placebo', 'aspirin', 'aspirin once daily or placebo', 'Aspirin']","['feasibility and safety', 'time to healing of the reference ulcer', 'ulcer size, pain evaluation, compliance and adverse events']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.170987,"Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established.
","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tilbrook', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. helen.tilbrook@york.ac.uk.'}, {'ForeName': 'Rachael O', 'Initials': 'RO', 'LastName': 'Forsythe', 'Affiliation': ""St George's Vascular Institute, St George's Healthcare NHS Trust, Blackshaw Road, London, SW17 0QT, UK. rachael.forsythe@ed.ac.uk.""}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Rolfe', 'Affiliation': ""St George's University of London, London, UK. drolfe@sgul.ac.uk.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. laura.clark@york.ac.uk.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bland', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. martin.bland@york.ac.uk.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Buckley', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. hannah.buckley@york.ac.uk.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chetter', 'Affiliation': 'Hull York Medical School, University of Hull, Kingston upon Hull, UK. ian.chetter@hey.nhs.uk.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. liz.cook@york.ac.uk.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dumville', 'Affiliation': 'School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK. jo.dumville@manchester.ac.uk.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. rhian.gabe@york.ac.uk.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Harding', 'Affiliation': 'Wound Healing Research Unit, Cardiff University, Cardiff, UK. hardingkg@cf.ac.uk.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Layton', 'Affiliation': 'Harrogate and District NHS Foundation Trust, London, UK. alison.layton@hdft.nhs.uk.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Lindsay', 'Affiliation': 'The Lindsay Leg Club Foundation, London, UK. ellie@legclubfoundation.com.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. catriona.mcdaid@york.ac.uk.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Moffatt', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK. christine.moffatt@nottingham.ac.uk.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK. C.J.Phillips@swansea.ac.uk.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Stansby', 'Affiliation': 'School of Surgical and Reproductive Sciences, Newcastle University, Newcastle upon Tyne, UK. Gerard.Stansby@nuth.nhs.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vowden', 'Affiliation': 'University of Bradford, Bradford, UK. peter.vowden@mac.com.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': ""St George's Vascular Institute, St George's Healthcare NHS Trust, Blackshaw Road, London, SW17 0QT, UK. laurie.williams49@gmail.com.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences, York Trials Unit, University of York, York, UK. david.torgerson@york.ac.uk.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hinchliffe', 'Affiliation': ""St George's Vascular Institute, St George's Healthcare NHS Trust, Blackshaw Road, London, SW17 0QT, UK. rhinchli@sgul.ac.uk.""}]",Trials,['10.1186/s13063-015-1039-9']
1348,27033753,"[Homoharringtonine in newly diagnosed acute promyelocytic leukemia treatment: a prospective, randomized controlled trial].","OBJECTIVE


To compare the efficacy and toxicities of combining homoharringtonine (HHT)±daunorubicin (DNR) with all-trans-retinoic acid (ATRA) based therapy and DNR plus ATRA based therapy in newly diagnosed low/intermediate risk acute promyelocytic leukemia (APL).
METHODS


A total of 96 newly diagnosed patients with APL were randomized to HHT group, DNR group and HHT+ DNR group prospectively. The complete remission (CR) rate, the overall survival (OS) and event-free survival (EFS) of three groups were analyzed.
RESULTS


There were 31 patients in HHT group, 33 patients in DNR group and 32 patients in HHT+ DNR group. The baseline characteristics of three groups were similar. No patient died during induction therapy. The morphologic CR rate was 100.0%. The median time to peak WBC counts in HHT+DNR group (4 days, range: 1-23 days) was significantly shorter than that in HHT group (9 days, range: 1-27 days) (P=0.008) and DNR group (7 days, range: 1-27 days) (P=0.240). There was no difference among three groups about the incidence of differentiation syndrome, the median interval to achieve CR, peak WBC counts and transfusions (P >0.05). All patients achieved complete molecular remission (CMR) during consolidation therapy. The interval to achieve CMR was no significantly difference among three groups (P >0.05). The 3-year OS rates for HHT group, DNR group and HHT+DNR group were 95.0%, 100.0% and 91.0%, respectively (P=0.595). The 3-year EFS rates for three groups were 93.0%, 90.0% and 85.0% (P=0.382). No difference was found in the incidence of adverse events among three groups (P >0.05).
CONCLUSIONS


Similar to DNR plus ATRA based therapy, HHT plus ATRA based induction and consolidation therapy should be one of highly-efficient treatment options for newly diagnosed APL. Clinical trial registration Chinese Clinical Trial Registry, ChiCTR-TRC-12002628.",2016,"There was no difference among three groups about the incidence of differentiation syndrome, the median interval to achieve CR, peak WBC counts and transfusions (P >0.05).","['newly diagnosed low/intermediate risk acute promyelocytic leukemia (APL', '31 patients in HHT group, 33 patients in DNR group and 32 patients in HHT+ DNR group', 'newly diagnosed acute promyelocytic leukemia treatment', '96 newly diagnosed patients with APL']","['homoharringtonine (HHT)±daunorubicin (DNR) with all-trans-retinoic acid (ATRA) based therapy and DNR plus ATRA based therapy', 'HHT', 'HHT plus ATRA', 'Homoharringtonine', 'DNR group and HHT+ DNR']","['complete remission (CR) rate, the overall survival (OS) and event-free survival (EFS', '3-year OS rates', 'incidence of differentiation syndrome, the median interval to achieve CR, peak WBC counts and transfusions', 'efficacy and toxicities', 'morphologic CR rate', 'interval to achieve CMR', 'median time to peak WBC counts', 'complete molecular remission (CMR', '3-year EFS rates', 'incidence of adverse events']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0062941', 'cui_str': 'omacetaxine mepesuccinate'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0860564', 'cui_str': 'Differentiation syndrome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",96.0,0.0639346,"There was no difference among three groups about the incidence of differentiation syndrome, the median interval to achieve CR, peak WBC counts and transfusions (P >0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Leukemia Center, Institute of Hematology & Blood Disease Hospital, CAMS & PUMC, Tianjin 300020, China.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'K Q', 'Initials': 'KQ', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'X L', 'Initials': 'XL', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'R X', 'Initials': 'RX', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Mi', 'Affiliation': ''}, {'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Wang', 'Affiliation': ''}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2016.03.002']
1349,32019981,Comparisons between end-effector and exoskeleton rehabilitation robots regarding upper extremity function among chronic stroke patients with moderate-to-severe upper limb impairment.,"End-effector (EE) and exoskeleton (Exo) robots have not been directly compared previously. The present study aimed to directly compare EE and Exo robots in chronic stroke patients with moderate-to-severe upper limb impairment. This single-blinded, randomised controlled trial included 38 patients with stroke who were admitted to the rehabilitation hospital. The patients were equally divided into EE and Exo groups. Baseline characteristics, including sex, age, stroke type, brain lesion side (left/right), stroke duration, Fugl-Meyer Assessment (FMA)-Upper Extremity score, and Wolf Motor Function Test (WMFT) score, were assessed. Additionally, impairment level (FMA, motor status score), activity (WMFT), and participation (stroke impact scale [SIS]) were evaluated. There were no significant differences in baseline characteristics between the groups. After the intervention, improvements were significantly better in the EE group with regard to activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation). There was no intervention-related adverse event. The EE robot intervention is better than the Exo robot intervention with regard to activity and participation among chronic stroke patients with moderate-to-severe upper limb impairment. Further research is needed to confirm this novel finding.",2020,"After the intervention, improvements were significantly better in the EE group with regard to activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation).","['chronic stroke patients with moderate-to-severe upper limb impairment', '38 patients with stroke who were admitted to the rehabilitation hospital']","['exoskeleton rehabilitation robots', 'EE and Exo robots', 'End-effector (EE) and exoskeleton (Exo) robots']","['impairment level (FMA, motor status score), activity (WMFT), and participation (stroke impact scale [SIS', 'activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation', 'sex, age, stroke type, brain lesion side (left/right), stroke duration, Fugl-Meyer Assessment (FMA)-Upper Extremity score, and Wolf Motor Function Test (WMFT) score']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain (finding)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",38.0,0.020525,"After the intervention, improvements were significantly better in the EE group with regard to activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation).","[{'ForeName': 'Stephanie Hyeyoung', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Gyulee', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Duk Youn', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ha Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Yeong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Law, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Si-Bog', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea. asfreelyas@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-58630-2']
1350,32064135,"The effects of steamed ginger ethanolic extract on weight and body fat loss: a randomized, double-blind, placebo-controlled clinical trial.","Steamed ginger ethanolic extract (SGE) is a product with a high 6-shogaol contents and is thought to be more potent than other ginger products. We conducted a 12-week, randomized, double-blind, placebo-controlled clinical trial to determine the effects of SGE on weight and body fat loss. Eighty healthy obese participants were recruited and randomly divided into the SGE and placebo groups. The outcome measures comprised indicators of efficacy (body weight, body mass index, body composition, and blood markers) and safety. Following the supplementation period, mean body weight, body mass index, and body fat level were significantly lower in the SGE group than in the placebo group. No clinically significant changes were observed for any safety parameter. These results suggest that SGE is a potent anti-obesity agent that does not cause significant side effects. Therefore, SGE supplementation combined with lifestyle modification could be effective in the management of body weight and fat mass.",2020,"Following the supplementation period, mean body weight, body mass index, and body fat level were significantly lower in the SGE group than in the placebo group.",['Eighty healthy obese participants'],"['steamed ginger ethanolic extract', 'SGE supplementation combined with lifestyle modification', 'Steamed ginger ethanolic extract (SGE', 'placebo', 'SGE', 'SGE and placebo']","['indicators of efficacy (body weight, body mass index, body composition, and blood markers) and safety', 'mean body weight, body mass index, and body fat level', 'weight and body fat loss']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005768'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",80.0,0.382777,"Following the supplementation period, mean body weight, body mass index, and body fat level were significantly lower in the SGE group than in the placebo group.","[{'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': '1Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': '1Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': '1Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Ki-Chan', 'Initials': 'KC', 'LastName': 'Ha', 'Affiliation': 'Healthcare Claims and Management Incorporated, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Hyang-Im', 'Initials': 'HI', 'LastName': 'Baek', 'Affiliation': 'Healthcare Claims and Management Incorporated, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Yu-Kyung', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Healthcare Claims and Management Incorporated, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Kap-Hoon', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': '4Department of Pharmaceutical Engineering, Woosuk University, Wanju-Gun, Republic of Korea.'}, {'ForeName': 'Soon-Yeon', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Healthy Local Food Branding Agency, Wanju-Gun, Republic of Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Healthy Local Food Branding Agency, Wanju-Gun, Republic of Korea.'}, {'ForeName': 'Youn-Soo', 'Initials': 'YS', 'LastName': 'Cha', 'Affiliation': '2Department of Food Science and Human Nutrition, Chonbuk National University, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Byung-Hyun', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': '6Department of Biochemistry, Chonbuk National University Medical School, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': '1Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju-si, Republic of Korea.'}]",Food science and biotechnology,['10.1007/s10068-019-00649-x']
1351,31552584,Prednisolone or hydrocortisone replacement in patients with corticotrope deficiency fasting during Ramadan result in similar risks of complications and quality of life: a randomized double-blind controlled trial.,"PURPOSE


The aims of the study were to compare the risk of complications and the quality of life in patients with corticotrope deficiency, who fasted during Ramadan. Both hydrocortisone and prednisolone were compared as treatments.
METHODS


A randomized double-blind crossover clinical trial conducted in the department of Endocrinology of the University Hospital la Rabta in Tunis, during Ramadan 2018, on 53 patients with known corticotrope deficiency treated with hydrocortisone 20 mg per day and who were willing to fast during Ramadan. Patients were randomized into two groups; AB that received hydrocortisone twice daily for 14 days then prednisolone once daily with a placebo for 14 days and group BA that received the two treatments in the reverse order. Patients had to complete a daily follow-up sheet about their eating and sleeping habits, the occurrence of complications and blood glucose monitoring and also to respond to the AddiQoL questionnaire at the end of each treatment period.
RESULTS


Fifty patients' data were analyzed; 29 men, mean age: 42.4 ± 13.3 years, mean duration of the disease: 8.1 ± 7.6 years. The frequency of complications, mean blood glucose levels and the quality of life did not differ on hydrocortisone compared to prednisolone after adjustment for the sequence of the treatment.
CONCLUSIONS


the risks of Ramadan fasting in patients with corticotrope deficiency were the same on hydrocortisone or prednisolone.",2020,"The frequency of complications, mean blood glucose levels and the quality of life did not differ on hydrocortisone compared to prednisolone after adjustment for the sequence of the treatment.
","[""Fifty patients' data were analyzed; 29 men, mean age: 42.4\u2009±\u200913.3 years, mean duration of the disease: 8.1\u2009±\u20097.6 years"", 'department of Endocrinology of the University Hospital la Rabta in Tunis, during Ramadan 2018, on 53 patients with known corticotrope deficiency treated with', 'patients with corticotrope deficiency, who fasted during Ramadan', 'patients with corticotrope deficiency', 'patients with corticotrope deficiency fasting during Ramadan result in similar']","['prednisolone', 'hydrocortisone and prednisolone', 'hydrocortisone 20\u2009mg per day and who were willing to fast during Ramadan', 'Prednisolone or hydrocortisone replacement', 'placebo', 'hydrocortisone or prednisolone', 'hydrocortisone']","['frequency of complications, mean blood glucose levels and the quality of life', 'risks of complications and quality of life', 'risk of complications and the quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0445341', 'cui_str': 'Tunis (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0986553', 'cui_str': 'Hydrocortisone 20 MG'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0034380'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",50.0,0.255255,"The frequency of complications, mean blood glucose levels and the quality of life did not differ on hydrocortisone compared to prednisolone after adjustment for the sequence of the treatment.
","[{'ForeName': 'Melika', 'Initials': 'M', 'LastName': 'Chihaoui', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia. melikachihaoui@yahoo.fr.'}, {'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'Mimita', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}, {'ForeName': 'Ibtissem', 'Initials': 'I', 'LastName': 'Oueslati', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}, {'ForeName': 'Ons', 'Initials': 'O', 'LastName': 'Rejeb', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}, {'ForeName': 'Zohra', 'Initials': 'Z', 'LastName': 'Ben Amor', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}, {'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'Grira', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'Yazidi', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Chaker', 'Affiliation': 'Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}]",Endocrine,['10.1007/s12020-019-02082-w']
1352,30489095,The implementation of a team training intervention for school mental health: Lessons learned.,"Children obtain more mental health services through schools than through any other system. In urban, low-resource schools, mental health care often is provided by teams of contracted community mental health workers. Implementation of intended services may struggle in the context of challenges related to team functioning. Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an efficacious approach for improving team functioning in health care. In collaboration with stakeholders, we adapted TeamSTEPPS for school mental health teams and pilot-tested it in 3 schools participating in an ongoing implementation of cognitive-behavioral therapy. In total, 3 teams randomized to receive TeamSTEPPS were compared with 3 teams who did not participate in TeamSTEPPS. Feasibility and acceptability of the adapted TeamSTEPPS and the impact on team skills and behavior were assessed through qualitative interviews and field notes and quantitatively over the course of 1 school year. In this article, we describe the process of adapting and implementing TeamSTEPPS. In addition to providing the researchers' perspective, we illustrate participant perspectives using qualitative data when possible. Key challenges included leader and staff turnover, logistical barriers (e.g., difficulty securing private space for qualitative interviews in schools), and navigating the protection of participant rights and autonomy given that prospective participants were employed by an agency with a vested interest in their participation. Concrete suggestions for overcoming challenges are provided to guide future research. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an efficacious approach for improving team functioning in health care.,"['school mental health', '3 schools participating in an ongoing implementation of cognitive-behavioral therapy']","['TeamSTEPPS', 'team training intervention', 'adapted TeamSTEPPS']","['Feasibility and acceptability', 'mental health services']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]",3.0,0.0654272,Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an efficacious approach for improving team functioning in health care.,"[{'ForeName': 'Courtney Benjamin', 'Initials': 'CB', 'LastName': 'Wolk', 'Affiliation': 'Center for Mental Health Policy and Services Research, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Stewart', 'Affiliation': 'Center for Mental Health Policy and Services Research, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Eiraldi', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cronholm', 'Affiliation': 'Department of Family Medicine and Community Health, University of Pennsylvania.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Salas', 'Affiliation': 'Department of Psychology, Rice University.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Mandell', 'Affiliation': 'Center for Mental Health Policy and Services Research, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000179']
1353,26631085,Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial.,"OBJECTIVE


The purpose of this study is to evaluate the efficacy of a behavioral self-regulation intervention vs. active control condition using a parallel-group randomized clinical trial with a sample of center hemodialysis patients with chronic kidney disease.
METHOD


Participants were recruited from 8 hemodialysis treatment centers in the Midwest. Eligible patients were (a) fluid nonadherent as defined by an interdialytic weight gain >2.5 kg over a 4-week period, (b) >18 years of age, (c) English-speaking without severe cognitive impairment, (d) treated with center-based hemodialysis for >3 months, and (e) not living in a care facility in which meals were managed. Medical records were used to identify eligible patients. Patients were randomly assigned to either a behavioral self-regulation intervention or active control condition in which groups of 3-8 patients met for hour-long, weekly sessions for 7 weeks at their usual hemodialysis clinic. Primary analyses were intention-to-treat.
RESULTS


Sixty-one patients were randomized to the intervention while 58 were assigned to the attention-placebo support and discussion control. Covariate-adjusted between-subjects analyses demonstrated no unique intervention effect for the primary outcome, interdialytic weight gain (β = 0.13, p = 0.48). Significant within-subjects improvement over time was observed for the intervention group (β = -0.32, p = 0.014).
CONCLUSIONS


The present study found that participation in a behavioral self-regulation intervention resulted in no unique intervention effect on a key indicator of adherence for those with severe chronic kidney disease. There was, however, modest within-subjects improvement in interdialytic weight gain for the intervention group which meshes with other evidence showing the utility of behavioral interventions in this patient population. ClinicalTrials.gov Identifier: NCT01066949.",2016,"Significant within-subjects improvement over time was observed for the intervention group (β = -0.32, p = 0.014).
","['Sixty-one patients', 'Participants were recruited from 8 hemodialysis treatment centers in the Midwest', 'Patient Adherence to Fluid-Intake Restrictions in Hemodialysis', 'Eligible patients were (a) fluid nonadherent as defined by an interdialytic weight gain >2.5\xa0kg over a 4-week period, (b) >18\xa0years of age', 'center hemodialysis patients with chronic kidney disease', 'those with severe chronic kidney disease']","['attention-placebo support and discussion control', 'Behavioral Self-Regulation Intervention', 'behavioral self-regulation intervention', 'behavioral self-regulation intervention vs. active control condition', 'behavioral self-regulation intervention or active control condition']","['intention-to-treat', 'interdialytic weight gain']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}, {'cui': 'C1096076', 'cui_str': 'Fluid intake restriction'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",61.0,0.0706124,"Significant within-subjects improvement over time was observed for the intervention group (β = -0.32, p = 0.014).
","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'VA Iowa City Healthcare System, Iowa City, IA, USA.'}, {'ForeName': 'Quinn D', 'Initials': 'QD', 'LastName': 'Kellerman', 'Affiliation': 'VA Minneapolis Healthcare System, Minneapolis, MN, USA.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hillis', 'Affiliation': 'VA Iowa City Healthcare System, Iowa City, IA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Cvengros', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lawton', 'Affiliation': 'Department of Internal Medicine, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Christensen', 'Affiliation': 'Departments of Psychology and Internal Medicine, The University of Iowa, 11 Seashore Hall East, Iowa City, IA, 52242, USA. alan-christensen@uiowa.edu.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-015-9741-0']
1354,32090939,Fracture strength of lithium disilicate cantilever resin bonded fixed dental prosthesis.,"OBJECTIVES


Metal and Zirconia cantilever resin bonded fixed dental prosthesis (RBFDPs) are extensively used when missing anterior teeth. Lithium disilicate is not used a lot as it is not indicated by the manufacturers. The aim of this in vitro study was to investigate the fracture strength of lithium disilicate cantilever RBFDPs with different configurations and compare them to metal and zirconium RBFDPs.
METHODS


Sound extracted human canines (N = 60) were divided into six groups, to be restored with a cantilever RBFDP. Specimen were randomly divided over 6 groups (n = 10): Full crown of lithium disilicate (FCL); Veneer wing of lithium disilicate (VL); Connector of lithium disilicate (CL); Palatal wing of lithium disilicate (PL); Palatal wing of zirconia (PZ) and Palatal wing of metal ceramic (PM). All bridges were bonded with an adhesive system. After thermalcyclic ageing (20 × 10 3 x, 5-55 °C) all samples were loaded until fracture occurred. Failure types were classified and representative SEM done.
RESULTS


The mean fracture strength results per group were: 588N (FCL) 588N (PM), 550N (CL), 534N (PL), 465N (VL), 38N (PZ). A significant (p = 0.001) difference was found between the groups, all groups had a higher fracture strength than the zirconia RBFDPs. Failure type analysis showed some trends among the groups. Irrepairable fractures of the root were only seen in samples restored with lithium disilicate. Metal and zirconia RBFDPs predominantly failed on the adhesive interface, where 60% of the zirconia samples had pretest debondings.
SIGNIFICANCE


No differences in fracture strength were found between cantilever RBFDPs made from metal or lithium disilicate. Metal (0% pre-test failures) and zirconium (60% pretest failures) RBFDPs failed predominantly on the adhesive interface whereas the lithium disilicate (0% pre-test failures) samples showed fractures in the contact area. The least invasive connector (CL) and Metal (PM) RBFDP obtained a high fracture strength and optimal fracture pattern.",2020,The least invasive connector (CL) and Metal (PM) RBFDP obtained a high fracture strength and optimal fracture pattern.,"['Sound extracted human canines (N\xa0', 'Metal and Zirconia cantilever resin bonded fixed dental prosthesis (RBFDPs', 'lithium disilicate cantilever resin bonded fixed dental prosthesis']","['Lithium disilicate', 'Full crown of lithium disilicate (FCL); Veneer wing of lithium disilicate (VL); Connector of lithium disilicate (CL); Palatal wing of lithium disilicate (PL); Palatal wing of zirconia (PZ) and Palatal wing of metal ceramic (PM', 'lithium disilicate']","['least invasive connector (CL) and Metal (PM) RBFDP', 'fracture strength', 'mean fracture strength', 'Fracture strength']","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0162686', 'cui_str': 'Dental Prosthesis'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}]","[{'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0559953', 'cui_str': 'Veneer (physical object)'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",60.0,0.0266987,The least invasive connector (CL) and Metal (PM) RBFDP obtained a high fracture strength and optimal fracture pattern.,"[{'ForeName': 'Marco M M', 'Initials': 'MMM', 'LastName': 'Gresnigt', 'Affiliation': 'University Medical Center Groningen, The University of Groningen, Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, the Netherlands; Martini Hospital, Department of Special Dental Care, Groningen, the Netherlands. Electronic address: marcogresnigt@yahoo.com.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Tirlet', 'Affiliation': 'Private Practice, Paris, France.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Bošnjak', 'Affiliation': 'University Medical Center Groningen, The University of Groningen, Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, the Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'van der Made', 'Affiliation': 'Dental Laboratory Kwalident, Beilen, the Netherlands.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Attal', 'Affiliation': 'Unité de Recherche en Biomatériaux, Innovations et Interfaces - EA 4462, Faculté de Chirurgie Dentaire, Université Paris Descartes, Hôpital Charles Foix, Ivry-sur-Seine, France.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.103615']
1355,31385881,Randomized Clinical Trial of an ICU Recovery Pilot Program for Survivors of Critical Illness.,"OBJECTIVES


To examine the effect of an interdisciplinary ICU recovery program on process measures and clinical outcomes.
DESIGN


A prospective, single-center, randomized pilot trial.
SETTING


Academic, tertiary-care medical center.
PATIENTS


Adult patients admitted to the medical ICU for at least 48 hours with a predicted risk of 30-day same-hospital readmission of at least 15%.
INTERVENTIONS


Patients randomized to the ICU recovery program group were offered a structured 10-intervention program, including an inpatient visit by a nurse practitioner, an informational pamphlet, a 24 hours a day, 7 days a week phone number for the recovery team, and an outpatient ICU recovery clinic visit with a critical care physician, nurse practitioner, pharmacist, psychologist, and case manager. For patients randomized to the usual care group, all aspects of care were determined by treating clinicians.
MEASUREMENTS AND MAIN RESULTS


Among the primary analysis of enrolled patients who survived to hospital discharge, patients randomized to the ICU recovery program (n = 111) and usual care (n = 121) were similar at baseline. Patients in the ICU recovery program group received a median of two interventions compared with one intervention in the usual care group (p < 0.001). A total of 16 patients (14.4%) in the ICU recovery program group and 26 patients (21.5%) in the usual care group were readmitted to the study hospital within 30 days of discharge (p = 0.16). For these patients, the median time to readmission was 21.5 days (interquartile range, 11.5-26.2 d) in the ICU recovery program group and 7 days (interquartile range, 4-21.2 d) in the usual care group (p = 0.03). Four patients (3.6%) in the ICU recovery program and 14 patients (11.6%) in the usual care group were readmitted within 7 days of hospital discharge (p = 0.02). The composite outcome of death or readmission within 30 days of hospital discharge occurred in 20 patients (18%) in the ICU recovery program group and 36 patients (29.8%) in usual care group (p = 0.04).
CONCLUSIONS


This randomized pilot trial found that a multidisciplinary ICU recovery program could deliver more interventions for post ICU recovery than usual care. The finding of longer time-to-readmission with an ICU recovery program should be examined in future trials.",2019,This randomized pilot trial found that a multidisciplinary ICU recovery program could deliver more interventions for post ICU recovery than usual care.,"['Adult patients admitted to the medical ICU for at least 48 hours with a predicted risk of 30-day same-hospital readmission of at least 15', 'Survivors of Critical Illness', 'enrolled patients who survived to hospital discharge, patients randomized to the ICU recovery program (n = 111) and usual care (n = 121', 'Academic, tertiary-care medical center']","['ICU Recovery Pilot Program', 'ICU recovery program group were offered a structured 10-intervention program, including an inpatient visit by a nurse practitioner, an informational pamphlet', 'interdisciplinary ICU recovery program']","['hospital discharge', 'death or readmission within 30 days of hospital discharge', 'median time to readmission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0356935,This randomized pilot trial found that a multidisciplinary ICU recovery program could deliver more interventions for post ICU recovery than usual care.,"[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Bloom', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Stollings', 'Affiliation': 'Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Kirkpatrick', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Sevin', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}]",Critical care medicine,['10.1097/CCM.0000000000003909']
1356,27117727,Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial.,"Study Design Feasibility randomized clinical trial. Background Rehabilitation may be an appropriate treatment strategy for patients with chronic hip joint pain; however, the evidence related to the effectiveness of rehabilitation is limited. Objectives To assess feasibility of performing a randomized clinical trial to investigate the effectiveness of movement-pattern training (MPT) to improve function in people with chronic hip joint pain. Methods Thirty-five patients with chronic hip joint pain were randomized into a treatment (MPT) group or a control (wait-list) group. The MPT program included 6 one-hour supervised sessions and incorporated (1) task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature. The wait-list group received no treatment. Primary outcomes for feasibility were patient retention and adherence. Secondary outcomes to assess treatment effects were patient-reported function (Hip disability and Osteoarthritis Outcome Score), lower extremity kinematics, and hip muscle strength. Results Retention rates did not differ between the MPT (89%) and wait-list groups (94%, P = 1.0). Sixteen of the 18 patients (89%) in the MPT group attended at least 80% of the treatment sessions. For the home exercise program, 89% of patients reported performing their home program at least once per day. Secondary outcomes support the rationale for conduct of a superiority randomized clinical trial. Conclusion Based on retention and adherence rates, a larger randomized clinical trial appears feasible and warranted to assess treatment effects more precisely. Data from this feasibility study will inform our future clinical trial. Level of Evidence Therapy, level 2b-. J Orthop Sports Phys Ther 2016;46(6):452-461. Epub 26 Apr 2016. doi:10.2519/jospt.2016.6279.",2016,Sixteen of the 18 patients (89%) in the MPT group attended at least 80% of the treatment sessions.,"['Methods Thirty-five patients with chronic hip joint pain', 'people with chronic hip joint pain', 'patients with chronic hip joint pain', 'People', 'With Chronic Hip Joint Pain']","['task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature', ' Rehabilitation', 'Movement-Pattern Training', 'movement-pattern training (MPT', 'MPT', 'treatment (MPT']","['retention and adherence rates', 'patient retention and adherence', 'Results Retention rates', 'patient-reported function (Hip disability and Osteoarthritis Outcome Score), lower extremity kinematics, and hip muscle strength']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2960679', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",35.0,0.146087,Sixteen of the 18 patients (89%) in the MPT group attended at least 80% of the treatment sessions.,"[{'ForeName': 'Marcie', 'Initials': 'M', 'LastName': 'Harris-Hayes', 'Affiliation': ''}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Czuppon', 'Affiliation': ''}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Van Dillen', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steger-May', 'Affiliation': ''}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Sahrmann', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Schootman', 'Affiliation': ''}, {'ForeName': 'Gretchen B', 'Initials': 'GB', 'LastName': 'Salsich', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Clohisy', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mueller', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2016.6279']
1357,27084025,Process Evaluation of the Project SHINE Intervention for African American Families: An Integrated Positive Parenting and Peer Monitoring Approach to Health Promotion.,"This study describes the process evaluation of Project SHINE, a randomized family-based health promotion intervention that integrated parenting and peer monitoring for improving sedentary behavior, physical activity, and diet in African American families. Adolescent-parent dyads (n = 89) were randomized to a 6-week behavioral, positive parenting, and peer monitoring skills intervention or a general health education comparison condition. Process evaluation included observational ratings of fidelity, attendance records, psychosocial measures, and qualitative interviews. Results indicated that the intervention was delivered with high fidelity based on facilitator adherence (>98% of content delivered) and competent use of theoretically based behavior change and positive parenting skills (100% of ratings >3 on a 1-4 scale). Although only 43% of peers attended the ""bring a friend"" session, overall attendance was high (4.39 ± 1.51 sessions) as was the retention rate (88%). Parents in the intervention condition reported significant improvements in communication related to adolescents' engagement in health behaviors both on their own and with peers. These findings were supported by qualitative themes related to improvements in family communication and connectedness. This study provides an innovative example of how future family-based health promotion trials can expand their process evaluation approaches by assessing theoretically relevant positive parenting variables as part of ongoing monitoring.",2016,Parents in the intervention condition reported significant improvements in communication related to adolescents' engagement in health behaviors both on their own and with peers.,"['Adolescent-parent dyads (n = 89', 'African American Families', 'African American families']","['Project SHINE Intervention', 'health promotion intervention that integrated parenting and peer monitoring', '6-week behavioral, positive parenting, and peer monitoring skills intervention or a general health education comparison condition']","['overall attendance', ""communication related to adolescents' engagement in health behaviors"", 'retention rate', 'behavior change and positive parenting skills', 'facilitator adherence', 'observational ratings of fidelity, attendance records, psychosocial measures, and qualitative interviews']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018687'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",89.0,0.0170063,Parents in the intervention condition reported significant improvements in communication related to adolescents' engagement in health behaviors both on their own and with peers.,"[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA s.stgeorge@med.miami.edu.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'McDaniel', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Kassandra A', 'Initials': 'KA', 'LastName': 'Alia', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}]",Health promotion practice,['10.1177/1524839916635977']
1358,32421226,Bevacizumab plus chemotherapy in nonsquamous non-small cell lung cancer patients with malignant pleural effusion uncontrolled by tube drainage or pleurodesis: A phase II study North East Japan Study group trial NEJ013B.,"BACKGROUND


Pleurodesis is the standard of care for non-small cell lung cancer (NSCLC) patients with symptomatic malignant pleural effusion (MPE). However, there is no standard management for MPE uncontrolled by pleurodesis. Most patients with unsuccessful MPE control are unable to receive effective chemotherapy. Vascular endothelial growth factor (VEGF) plays an important role in the pathogenesis of MPE. This multicenter, phase II study investigated the effects of bevacizumab plus chemotherapy in nonsquamous NSCLC patients with unsuccessful management of MPE.
METHODS


Nonsquamous NSCLC patients with MPE following unsuccessful tube drainage or pleurodesis received bevacizumab (15 mg/kg) plus chemotherapy every three weeks. The primary endpoint was pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE at eight weeks. Secondary endpoints included pleural progression-free survival (PPFS), safety, and quality of life (QoL).
RESULTS


A total of 20 patients (median age: 69 years; 14 males; 20 adenocarcinomas; six epidermal growth factor receptor mutations) were enrolled in nine centers. The PECR was 80% and the primary end point was met. The PPFS and the overall survival (OS) were 16.6 months and 19.6 months, respectively. Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002). Toxicities of grade ≥ 3 included neutropenia (50%), thrombocytopenia (10%), proteinuria (10%), and hypertension (2%). The cognitive QoL score improved after treatment.
CONCLUSIONS


Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE, and should be considered as a standard therapy in this setting.
KEY POINTS


SIGNIFICANT FINDINGS OF THE STUDY: Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE.
WHAT THIS STUDY ADDS


Bevacizumab plus chemotherapy should be considered as a standard treatment option for patients with uncontrolled MPE.
CLINICAL TRIAL REGISTRATION


UMIN000006868 was a phase II study of efficacy of bevacizumab plus chemotherapy for the management of malignant pleural effusion (MPE) in nonsquamous non-small cell lung cancer patients with MPE unsuccessfully controlled by tube drainage or pleurodesis (North East Japan Study Group Trial NEJ-013B) (http://umin.sc.jp/ctr/).",2020,Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002).,"['nonsquamous NSCLC patients with unsuccessful management of MPE', 'Nonsquamous NSCLC patients with MPE following unsuccessful tube drainage or pleurodesis received', 'nonsquamous non-small cell lung cancer patients with MPE unsuccessfully controlled by', '20 patients (median age: 69\u2009years; 14 males; 20 adenocarcinomas; six epidermal growth factor receptor mutations) were enrolled in nine centers', 'nonsquamous non-small cell lung cancer patients with malignant pleural effusion uncontrolled by tube drainage or pleurodesis', 'non-small cell lung cancer (NSCLC) patients with symptomatic malignant pleural effusion (MPE', 'nonsquamous NSCLC patients with uncontrolled MPE', 'patients with uncontrolled MPE']","['tube drainage or pleurodesis', 'Bevacizumab plus chemotherapy', 'bevacizumab', 'bevacizumab plus chemotherapy']","['cognitive QoL score', 'thrombocytopenia', 'shorter PPFS', 'pleural progression-free survival (PPFS), safety, and quality of life (QoL', 'Toxicities of grade\u2009≥\u20093 included neutropenia', 'pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE', 'overall survival (OS']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",20.0,0.123536,Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002).,"[{'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Noro', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory medicine, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Usuki', 'Affiliation': 'Department of Pulmonary Medicine, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Yomota', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Nishitsuji', 'Affiliation': 'Department of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Internal Medicine, Jizankai Medical Foundation Tsuboi Cancer Center Hospital, Fukushima, Japan.'}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Hino', 'Affiliation': 'Department of Pulmonary Medicine, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Division of Pulmonary Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Miyanaga', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seike', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thoracic cancer,['10.1111/1759-7714.13472']
1359,32419117,Emotion Regulation among Children in Foster Care Versus Birth Parent Care: Differential Effects of an Early Home-Visiting Intervention.,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning. The current study uses two randomized control trials, one conducted with foster caregivers and one conducted with birth parents, to investigate the longitudinal effects of caregiver type (foster versus birth parent) and a home-visiting parenting intervention on emotion regulation among young children referred to CPS. Participants were 211 children referred to CPS during infancy or toddlerhood, of whom 120 remained with their birth parents and 91 were placed in foster care. Caregivers were randomly assigned to receive Attachment and Biobehavioral Catch-Up (ABC), a 10-session intervention designed to promote nurturing, sensitive, and non-intrusive caregiving, or a control intervention. Caregiver type moderated the effects of ABC on young children's observed anger dysregulation during a frustrating task at age 2 to 3 years. Among children remaining with their birth parents, children whose caregivers received ABC showed lower anger dysregulation than children whose caregivers received the control intervention. Children placed in foster care showed lower anger dysregulation than children with birth parents regardless of parenting intervention, and additionally showed higher adaptive regulation than children remaining with their birth parents. Adaptive regulation was not significantly associated with parenting intervention or the caregiver by intervention interaction. Results suggest that foster care placement may be protective for emerging emotion regulation skills among young children referred to CPS, and an attachment-based parenting intervention buffers risks of remaining in the home for young children's emotion dysregulation.",2020,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning.","['young children', 'children remaining with their birth parents', 'young children referred to CPS', 'Versus Birth Parent Care', 'Participants were 211 children referred to CPS during infancy or toddlerhood, of whom 120 remained with their birth parents and 91 were placed in foster care', 'foster caregivers and one conducted with birth parents', 'Children in Foster Care']","['Attachment and Biobehavioral Catch-Up (ABC), a 10-session intervention designed to promote nurturing, sensitive, and non-intrusive caregiving, or a control intervention', 'ABC', 'Child Protective Services (CPS', 'Early Home-Visiting Intervention', 'caregiver type (foster versus birth parent) and a home-visiting parenting intervention']","['emotion regulation skills', 'anger dysregulation', 'Emotion Regulation', 'adaptive regulation', 'Adaptive regulation']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C3178496', 'cui_str': 'AM 211'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0580719', 'cui_str': 'Child in foster care'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",211.0,0.0309807,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning.","[{'ForeName': 'Madelyn H', 'Initials': 'MH', 'LastName': 'Labella', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA. mlabella@udel.edu.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Sellers', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}, {'ForeName': 'Caroline K P', 'Initials': 'CKP', 'LastName': 'Roben', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00653-4']
1360,32419310,Effect of high bicarbonate hemodialysis solution on biochemical parameters and anthropometric indices.,"INTRODUCTION


Protein energy wasting is an adverse consequence of renal failure, which is correlated with increased mortality and morbidity. Metabolic acidosis has a major role in the development of protein energy wasting in hemodialysis patients. Every effort that could ameliorate this catabolic state would be beneficial to stabilize body composition. The aim of this study was to investigate the possible beneficial effects of high bicarbonate dialysis on anthropometric indices and biochemical parameters of nutrition.
METHODS


Fifty-six hemodialysis patients were randomly enrolled in two groups: an intervention group that underwent hemodialysis for 6 months with high bicarbonate dialysate concentration (36 mmol/L, N = 26) and a control group that underwent hemodialysis using a bicarbonate dialysate concentration of 30 mmol/L (N = 30). Biochemical parameters of nutrition and weight, body mass index (BMI), total body water, percent body fat, and other anthropometric indices were measured at the beginning and the end of the trial.
FINDINGS


At the end of the 6 month evaluation period, plasma levels of albumin, phosphorus, K, calcium, and bicarbonate showed no significant changes. Body weight and BMI increased significantly in high bicarbonate arm but did not change significantly in the control group. Percent body fat in the arms and legs did not change in intervention arm, but decreased significantly in the controls.
DISCUSSION


The results suggest that higher bicarbonate dialysis can have beneficial effects on nutritional status and might protect against loss of fat mass.",2020,"Percent body fat in the arms and legs did not change in intervention arm, but decreased significantly in the controls.
","['Fifty-six hemodialysis patients', 'hemodialysis patients']","['bicarbonate hemodialysis solution', 'control group that underwent hemodialysis using a bicarbonate dialysate concentration of 30\u2009mmol/L', 'bicarbonate dialysis', 'intervention group that underwent hemodialysis for 6\u2009months with high bicarbonate dialysate concentration']","['plasma levels of albumin, phosphorus, K, calcium, and bicarbonate', 'Body weight and BMI', 'mortality and morbidity', 'Biochemical parameters of nutrition and weight, body mass index (BMI), total body water, percent body fat, and other anthropometric indices', 'biochemical parameters and anthropometric indices']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0019006', 'cui_str': 'Hemodialysis solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",56.0,0.0196057,"Percent body fat in the arms and legs did not change in intervention arm, but decreased significantly in the controls.
","[{'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Hefzollah', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Saeid Najafpour', 'Initials': 'SN', 'LastName': 'Boushehri', 'Affiliation': 'Department of Nutrition, School of Health and Nutrition, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mahmudpour', 'Affiliation': 'The Persian Gulf Tropical Medicine Research Center, The Persian Gulf Biomedical Sciences Research Institute, Bushehr University of Medical Sciences, Bushehr, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12842']
1361,26304075,"[Efficacy and safety of anagrelide in treatment of essential thrombocythemia: multicenter, randomized controlled clinical trial].","OBJECTIVE


To evaluate the efficacy and safety of anagrelide in essential thrombocythemia (ET).
METHODS


Patients who diagnosed as ET according to the World Health Organization classification were enrolled. Each patient was assigned to take anagrelide hydrochloride capsule or hydroxyurea tablet by random 1∶1 ratio. Dose of anagrelide started at 2 mg/d, then increased gradually and the maximum dose was 10 mg/d until the platelet counts dropped to (100-400) × 10⁹/L, one month later gradually reduced to maintain dose. The dose of hydroxyurea was 1000 mg/d at beginning, then increased gradually, when platelet counts dropped to (100-400)×10⁹/L and kept for one month, reduced to maintain dose as 10 mg·kg⁻¹·d⁻¹. The observation period was 12 weeks.
RESULTS


A total of 222 patients were enrolled in seventeen centers (including 113 patients treated with anagrelide and 109 with hydroxyurea). Therapy efficacy can be evaluated in 198 patients (including 97 patients administered with anagrelide and 101 with hydroxyurea). At 12th weeks of therapy, the hematologic remission rate was 87.63% (85/97) in anagrelide group and 88.12% (89/107) in hydroxyurea group, the differences between the two groups were not significant (P=0.173). Treatment with anagrelide lowered the platelet counts by a median of 393 (362-1 339) × 10⁹/L from a median of 827 (562-1657) × 109/L at the beginning of the observation to 400(127-1130)×10⁹/L after 12 weeks (P<0.001), which were similar to the treatment result of hydroxyurea by a median drop of 398 (597-1846)× 10⁹/L (P=0.982). The median time to achieving response of anagrelide group was 7 (3-14) days, superior to that of hydroxyurea for 21 (14-28) significantly (P=0.003). Frequency of anagrelide related adverse events was 65.49 % (74/113), including cardiopalmus (36.28% ), headache (21.24% ), fatigue (14.16% ) and dizzy (11.50% ).
CONCLUSION


Anagrelide was effective in patients with ET which had similar hematologic remission rate to hydroxyurea and could take effect more quickly than hydroxyurea. Incidence of adverse events was undifferentiated between anagrelide and hydroxyurea, but anagrelide treatment had tolerable adverse effects and no hematologic toxicity.",2015,"Incidence of adverse events was undifferentiated between anagrelide and hydroxyurea, but anagrelide treatment had tolerable adverse effects and no hematologic toxicity.","['198 patients (including 97 patients administered with anagrelide and 101 with hydroxyurea', 'Patients who diagnosed as ET according to the World Health Organization classification were enrolled', '× 10⁹/L from a median of 827 (562-1657', '222 patients were enrolled in seventeen centers (including 113 patients treated with anagrelide and 109 with hydroxyurea']","['hydroxyurea', 'anagrelide hydrochloride capsule or hydroxyurea tablet', 'anagrelide']","['median time to achieving response', 'Frequency of anagrelide related adverse events', 'dizzy', 'Incidence of adverse events', 'efficacy and safety', 'hematologic remission rate', 'Therapy efficacy', 'platelet counts', 'headache', 'tolerable adverse effects and no hematologic toxicity', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0051809', 'cui_str': 'anagrelide'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0771907', 'cui_str': 'Anagrelide hydrochloride'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0051809', 'cui_str': 'anagrelide'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0051809', 'cui_str': 'anagrelide'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",222.0,0.0831704,"Incidence of adverse events was undifferentiated between anagrelide and hydroxyurea, but anagrelide treatment had tolerable adverse effects and no hematologic toxicity.","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': 'Department of Hematology, the Second Hospital of Shanxi Medical University, Taiyuan 030001, China.'}, {'ForeName': 'Linhua', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, the Second Hospital of Shanxi Medical University, Taiyuan 030001, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': ''}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Renchi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Xiangshan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Shuye', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Aining', 'Initials': 'A', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ''}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2015.07.00']
1362,32419143,"Comment on ""Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single-center phase II clinical trial for safety and efficacy"".",,2020,,['gastric cancer'],[],[],"[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]",[],[],,0.0111715,,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Xiyin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Traditional Chinese Medicine, Community Health Service Center of Guali Town of Xiaoshan, Hangzhou, China.'}]",Journal of surgical oncology,['10.1002/jso.25954']
1363,31786163,Phase I/II open-label trial of intravenous allogeneic mesenchymal stromal cell therapy in adults with recessive dystrophic epidermolysis bullosa.,"BACKGROUND


Recessive dystrophic epidermolysis bullosa (RDEB) is a hereditary blistering disorder due to a lack of type VII collagen. At present, treatment is mainly supportive.
OBJECTIVES


To determine whether intravenous allogeneic bone marrow-derived mesenchymal stromal/stem cells (BM-MSCs) are safe in RDEB adults and if the cells improve wound healing and quality of life.
METHODS


We conducted a prospective, phase I/II, open-label study recruiting 10 RDEB adults to receive 2 intravenous infusions of BM-MSCs (on day 0 and day 14; each dose 2-4 × 10 6  cells/kg).
RESULTS


BM-MSCs were well tolerated with no serious adverse events to 12 months. Regarding efficacy, there was a transient reduction in disease activity scores (8/10 subjects) and a significant reduction in itch. One individual showed a transient increase in type VII collagen.
LIMITATIONS


Open-label trial with no placebo.
CONCLUSIONS


MSC infusion is safe in RDEB adults and can have clinical benefits for at least 2 months.",2020,"Regarding efficacy, there was transient reduction in disease activity scores (8 of 10 subjects) and significant reduction in itch.","['10 RDEB adults', 'adults with recessive dystrophic epidermolysis bullosa']","['intravenous allogeneic mesenchymal stromal cell therapy', 'intravenous infusions of BM-MSCs', 'placebo', 'intravenous allogeneic bone marrow-derived mesenchymal stromal/stem cells (BM-MSC', 'MSC infusion']","['disease activity scores', 'transient increase in C7', 'wound healing and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079474', 'cui_str': 'Hallopeau-Siemens Disease'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0034380'}]",,0.0278886,"Regarding efficacy, there was transient reduction in disease activity scores (8 of 10 subjects) and significant reduction in itch.","[{'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Rashidghamat', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Tendai', 'Initials': 'T', 'LastName': 'Kadiyirire', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Ayis', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Petrof', 'Affiliation': 'Department of Dermatology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Pullabhatla', 'Affiliation': ""UK NIHR GSTFT/KCL Comprehensive Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Chrysanthi', 'Initials': 'C', 'LastName': 'Ainali', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK; Dignosis Ltd, London, UK.""}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Guy', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Aristodemou', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McMillan', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ozoemena', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mee', 'Affiliation': ""Immunodermatology Laboratory, Viapath, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Rashida', 'Initials': 'R', 'LastName': 'Pramanik', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Alka', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': ""UK NIHR GSTFT/KCL Comprehensive Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rosamund', 'Initials': 'R', 'LastName': 'Nuamah', 'Affiliation': ""UK NIHR GSTFT/KCL Comprehensive Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'de Rinaldis', 'Affiliation': 'I&I Precision Immunology, Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Serrano', 'Affiliation': ""Clinical Trial Management Research Platform, NIHR Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Maurin', 'Affiliation': ""Clinical Trial Management Research Platform, NIHR Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Martinez-Queipo', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Su M', 'Initials': 'SM', 'LastName': 'Lwin', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Dusko', 'Initials': 'D', 'LastName': 'Ilic', 'Affiliation': ""Stem Cell Laboratories, Guy's Assisted Conception Unit, Department of Women & Children's Health, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Dermatology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Dazzi', 'Affiliation': ""Department of Haematological Medicine, The Rayne Institute, King's College London, London, UK.""}, {'ForeName': 'Ineke', 'Initials': 'I', 'LastName': 'Slaper-Cortenbach', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Westinga', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Zeddies', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'van den Broek', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Onoufriadis', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Jemima E', 'Initials': 'JE', 'LastName': 'Mellerio', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'McGrath', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK. Electronic address: john.mcgrath@kcl.ac.uk.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.11.038']
1364,32417925,A Randomized Trial to Compare Serratus Anterior Plane Block and Erector Spinae Plane Block for Pain Management Following Thoracoscopic Surgery.,"OBJECTIVE


Comparison of ultrasound (US)-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) in video-assisted thoracic surgery (VATS) patients. The primary outcome was to compare perioperative and postoperative (48 hours) opioid consumption.
METHODS


A total of 60 patients were randomized into two groups (N = 30): an ESPB group and an SAPB group. All the patients received intravenous patient-controlled postoperative analgesia and ibuprofen 400 mg intravenously every eight hours. Visual analog scale (VAS) scores, opioid consumption, and adverse events were recorded.
RESULTS


Intraoperative and postoperative opioid consumption at 0-8, 8-16, and 16-24 hours and rescue analgesic use were significantly lower in the ESPB group (P < 0.05). Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05). There was no significant difference between static VAS scores at the fourth hour. There were no differences between adverse effects. Block procedure time and one-time puncture success were similar between groups (P  > 0.05 each).
CONCLUSION


US-guided ESPB may provide better pain control than SAPB after VATS.
QUESTION


Even though there are studies about analgesia management after VATS, clinicians want to perform the technique that is both less invasive and more effective.
FINDINGS


This randomized trial showed that US-guided ESPB provides effective analgesia compared with SAPB.
MEANING


Performing single-injection ESPB reduces VAS scores and opioid consumption compared with SAPB.",2020,Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05).,"['Pain Management Following Thoracoscopic Surgery', '60 patients', 'video-assisted thoracic surgery (VATS) patients']","['Serratus Anterior Plane Block and Erector Spinae Plane Block', 'ESPB', 'US-guided ESPB', 'intravenous patient-controlled postoperative analgesia and ibuprofen', 'VATS', 'ultrasound (US)-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB']","['VAS scores and opioid consumption', 'Static/dynamic VAS scores', 'Intraoperative and postoperative opioid consumption', 'perioperative and postoperative (48 hours) opioid consumption', 'Visual analog scale (VAS) scores, opioid consumption, and adverse events', 'rescue analgesic use', 'Block procedure time and one-time puncture success', 'adverse effects', 'static VAS scores']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",60.0,0.139796,Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05).,"[{'ForeName': 'Mürsel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Birzat Emre', 'Initials': 'BE', 'LastName': 'Gölboyu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Manisa State Hospital, Manisa, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Bayrak', 'Affiliation': 'Department of Thoracic Surgery, Istanbul Medipol University, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Tulgar', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maltepe University, Istanbul, Turkey.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa101']
1365,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND


No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
MATERIALS AND METHODS


Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
RESULTS


The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
CONCLUSION


No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020']
1366,31533845,"Intermittent preventive treatment of malaria delivered to primary schoolchildren provided effective individual protection in Jinja, Uganda: secondary outcomes of a cluster-randomized trial (START-IPT).","BACKGROUND


Intermittent preventive treatment (IPT) of malaria is recommended as policy for certain high-risk populations, but not currently for schoolchildren. A cluster-randomized trial was conducted to evaluate the effect of IPT with dihydroartemisinin-piperaquine (DP) on primary schoolchildren in Jinja, Uganda. Results of the impact of IPT of schoolchildren on community-level transmission have been reported previously. Here, secondary outcomes from a school-based survey are presented.
METHODS


Eighty-four clusters (one primary school plus 100 households) were randomized to intervention and control (1:1 ratio). Participants from intervention schools received monthly IPT with DP for up to 6 rounds (June-December 2014). At endline (November-December 2014), randomly selected children from all 84 schools were surveyed (13 per school) and thick blood smears were done. Those with fever or history of fever were tested with rapid diagnostic tests (RDTs) for malaria. Haemoglobin was measured in every fifth participant. Outcome measures included prevalence of asexual parasites and gametocytes (by microscopy), and prevalence of anaemia. Prevalence outcomes were analysed using generalized linear Poisson models with log link function, incorporating a cluster-level random intercept and quantified using prevalence risk ratios.
RESULTS


Among 23,280 students listed on the 42 intervention school registers, 10,079 (43.3%) aged 5-20 years were enrolled into the IPT intervention and received at least one dose of DP; of these, 9286 (92.1%) received at least one full (3-day) course. In total, 1092 children were enrolled into the final school survey (546 per arm) and had a thick blood smear done; of these, 255 had haemoglobin measured (129 intervention, 126 control). Children in the intervention arm were less likely to have asexual parasites (9.2% intervention vs 44.1% control, adjusted risk ratio [aRR] 0.22 [95% CI 0.16-0.30] p < 0.001), gametocytes (3.1% intervention vs 9.5% control, aRR 0.34 [95% CI 0.20-0.56] p < 0.001), fever (20.2% intervention vs 56.2% control, aRR 0.35 [95% CI 0.25-0.50] p < 0.001), or symptomatic malaria (5.1% intervention vs 35.7% control, aRR 0.14 [95% CI 0.08-0.26] p < 0.001). Prevalence of anaemia and mean haemoglobin were similar in both study arms.
CONCLUSIONS


School-aged children are a major reservoir of malaria parasites. Delivering IPT to schoolchildren would benefit individual children and may reduce transmission. School-based IPT could help to intensify malaria control toward elimination, and should be considered for policies and programmes. Trial registration Clinicaltrials.gov (NCT02009215), Registered 11 December 2013. https://clinicaltrials.gov/ct2/show/NCT02009215.",2019,"p < 0.001), fever (20.2% intervention vs 56.2% control, aRR 0.35","['Eighty-four clusters (one primary school plus 100 households', 'primary schoolchildren in Jinja, Uganda', 'School-aged children', '1092 children were enrolled into the final school survey (546 per arm) and had a thick blood smear done; of these, 255 had haemoglobin measured (129 intervention, 126 control', '23,280 students listed on the 42 intervention school registers, 10,079 (43.3%) aged 5-20\xa0years were enrolled into the', 'At endline (November-December 2014), randomly selected children from all 84 schools were surveyed (13 per school) and thick blood smears were done']","['IPT with DP', 'IPT intervention and received at least one dose of DP', 'IPT with dihydroartemisinin-piperaquine (DP']","['gametocytes', 'Prevalence of anaemia and mean haemoglobin', 'fever or history of fever', 'adjusted risk ratio [aRR', 'symptomatic malaria', 'Haemoglobin', 'asexual parasites', 'prevalence of asexual parasites and gametocytes (by microscopy), and prevalence of anaemia', 'fever']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}]","[{'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0521066', 'cui_str': 'parasites'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}]",1092.0,0.179941,"p < 0.001), fever (20.2% intervention vs 56.2% control, aRR 0.35","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Rehman', 'Affiliation': 'Department of Infectious Disease Epidemiology, LSHTM, London, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maiteki-Sebuguzi', 'Affiliation': 'Infectious Diseases Research Collaboration, PO Box 7475, Kampala, Uganda.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Gonahasa', 'Affiliation': 'Infectious Diseases Research Collaboration, PO Box 7475, Kampala, Uganda.'}, {'ForeName': 'Jaffer', 'Initials': 'J', 'LastName': 'Okiring', 'Affiliation': 'Infectious Diseases Research Collaboration, PO Box 7475, Kampala, Uganda.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Kigozi', 'Affiliation': 'Infectious Diseases Research Collaboration, PO Box 7475, Kampala, Uganda.'}, {'ForeName': 'Clare I R', 'Initials': 'CIR', 'LastName': 'Chandler', 'Affiliation': 'Department of Global Health & Development, Department of Clinical Research, LSHTM, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Drakeley', 'Affiliation': 'Department of Infection and Immunity, LSHTM, London, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Staedke', 'Affiliation': 'Infectious Diseases Research Collaboration, PO Box 7475, Kampala, Uganda. sarah.staedke@lshtm.ac.uk.'}]",Malaria journal,['10.1186/s12936-019-2954-0']
1367,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS


Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS


Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
1368,32417348,Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND


Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy.
METHODS


Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP).
RESULTS


188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found.
CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.",2020,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: yungan.tao@gustaveroussy.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; INSERM 1018, Villefjuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France; Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France; Centre francois Baclesse, Caen, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes, France; Institut du Cancer de Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France; Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021']
1369,32416996,"Restricted versus liberal intraoperative benzodiazepine use in cardiac anaesthesia for reducing delirium (B-Free Pilot): a pilot, multicentre, randomised, cluster crossover trial.","BACKGROUND


Delirium is common after cardiac surgery and is associated with adverse outcomes. Perioperative benzodiazepine use is associated with delirium and is common during cardiac surgery, which may increase the risk of postoperative delirium. We undertook a pilot study to inform the feasibility of a large randomised cluster crossover trial examining whether an institutional policy of restricted benzodiazepine administration during cardiac surgery (compared with liberal administration) would reduce delirium.
METHODS


We conducted a two-centre, pilot, randomised cluster crossover trial with four 4 week crossover periods. Each centre was randomised to a policy of restricted or liberal use, and then alternated between the two policies during the remaining three periods. Our feasibility outcomes were adherence to each policy (goal ≥80%) and outcome assessment (one delirium assessment per day in the ICU in ≥90% of participants). We also evaluated the incidence of intraoperative awareness in one site using serial Brice questionnaires.
RESULTS


Of 800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium. Of these, 355/389 (91.3%) received benzodiazepines during the liberal benzodiazepine periods and 363/411 (88.3%) did not receive benzodiazepines during the restricted benzodiazepine periods. Amongst the 800 patients, 740 (92.5%) had ≥1 postoperative delirium assessment per day in the ICU. Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness.
CONCLUSIONS


This pilot study demonstrates the feasibility of a large, multicentre, randomised, cluster crossover trial examining whether an institutional policy of restricted vs liberal benzodiazepine use during cardiac surgery will reduce postoperative delirium.
CLINICAL TRIAL REGISTRATION


NCT03053869.",2020,"Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness.
","['521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted', '800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium']","['benzodiazepines', 'benzodiazepine', 'liberal intraoperative benzodiazepine']",['postoperative delirium assessment'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0919727', 'cui_str': 'Awareness During Anesthesia'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",800.0,0.304096,"Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spence', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada; Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada. Electronic address: Jessica.Spence@phri.ca.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Belley-Côté', 'Affiliation': 'Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada; Department of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Shun Fu', 'Initials': 'SF', 'LastName': 'Lee', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': 'Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Surgery (Cardiac Surgery), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Bangdiwala', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Syed', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Sarkaria', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacIsaac', 'Affiliation': 'School of Medicine, Faculty of Medicine, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lengyel', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Um', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'McIntyre', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Morvarid', 'Initials': 'M', 'LastName': 'Kavosh', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fast', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': 'Department of Critical Care, University of Manitoba, Winnipeg, MB, Canada; Department of Surgery (Cardiac Surgery), University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lamy', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Surgery (Cardiac Surgery), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.03.030']
1370,31549861,"The effects of an expressive writing intervention on pregnancy rates, alexithymia and psychophysical health during an assisted reproductive treatment.","Objective:  World Health Organization reported that in developed countries one in four couples experience infertility with serious implications for the psychophysical well-being. Aim of this study was to evaluate the effects of Pennebaker's writing technique on pregnancy rates, alexithymia and psychophysical health during an assisted reproductive treatment (ART). Method:  91 women admitted for an ART were randomly divided into two groups: an experimental one ( n  = 46), where women wrote about their thoughts and emotions concerning the infertility experience, and a control group ( n  = 45) where women did not write. All subjects completed a socio-demographic questionnaire, the 20-item Toronto Alexithymia Scale and the Symptoms Checklist-90-R before and after the writing sessions. Results:  A significant difference in pregnancy rates between the experimental group ( n  = 13) and the control group ( n  = 5) was found (χ 2  = 4.216;  p  < .04). A significant difference was also found between women who participated in the study (experimental + control= 91) and women who declined to participate, in the direction of more ART successes ( n  = 18 vs.  n  = 0) in the group of women who participated (χ 2  = 10.17;  p  < .01). Conclusions:  The findings support the usefulness of the writing technique during ART in promoting treatment success.",2020,A significant difference in pregnancy rates between the experimental group ( n  = 13) and the control group ( n  = 5) was found (χ 2  = 4.216;  p  < .04).,['91 women admitted for an ART'],"[""Pennebaker's writing technique"", 'women wrote about their thoughts and emotions concerning the infertility experience, and a control group', 'expressive writing intervention']","['pregnancy rates', 'ART successes', 'pregnancy rates, alexithymia and psychophysical health', 'socio-demographic questionnaire, the 20-item Toronto Alexithymia Scale and the Symptoms Checklist-90-R']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}]",91.0,0.0358192,A significant difference in pregnancy rates between the experimental group ( n  = 13) and the control group ( n  = 5) was found (χ 2  = 4.216;  p  < .04).,"[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Renzi', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Solano', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Di Trani', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ginobbi', 'Affiliation': 'Casamadre Association, Rome, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Minutolo', 'Affiliation': 'Department of Reproductive Medicine, Altamedica-Artemisia SpA, Rome, Italy.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Tambelli', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}]",Psychology & health,['10.1080/08870446.2019.1667500']
1371,31915433,"The Effectiveness, Tolerability, and Safety of Different 1-Day Bowel Preparation Regimens for Pediatric Colonoscopy.","Background


Currently, there is no generally accepted universal protocol for bowel preparation before colonoscopy in children.
Aim


The aim of the study was to compare three different 1-day bowel preparation methods for a pediatric elective colonoscopy in terms of their efficacy, safety, and patient-reported tolerability.
Material and Methods


The study was randomized, prospective, and investigator-blinded. All children aged 10 to 18 years consecutively referred to the tertiary pediatric gastroenterology unit were enrolled. The participants were randomized to receive polyethylene glycol 3350 combined with bisacodyl (PEG-bisacodyl group), or polyethylene glycol 4000 with electrolytes (PEG-ELS group), or sodium picosulphate plus magnesium oxide plus citric acid (NaPico+MgCit group). Bowel preparation was assessed according to the Boston Bowel Preparation Scale (BBPS). For patient tolerability and acceptability, questionnaires were obtained.
Results


One hundred twenty-three children were allocated to three age- and sex-matched groups. All of the patients completed colonoscopies with visualization of the cecum. There was no difference among the groups for the mean BBPS score. A total of 73 patients (59.3%) experienced minor adverse events. No serious adverse events occurred in any group. Nausea was the only symptom more frequent in the PEG-ELS group compared to the NaPico+MgCit group ( p  = 0.04), and apathy was the only symptom more frequent in PEG-bisacodyl than in the NaPico+MgCit group ( p  = 0.04). All of the patients were able to complete 75% or more of the study protocol, and 85.4% were able to complete the full regimen. The acceptability was the highest in the NaPico+MgCit group with respect to the patient's grade for palatability, low volume of the solution, and willingness to repeat the same protocol.
Conclusion


All bowel cleansing methods show similar efficacy. However, because of the higher tolerability and acceptability profile, the NaPico+MgCit-based regimen appears to be the most proper for colonoscopy preparation in children.",2019,"Nausea was the only symptom more frequent in the PEG-ELS group compared to the NaPico+MgCit group ( p  = 0.04), and apathy was the only symptom more frequent in PEG-bisacodyl than in the NaPico+MgCit group ( p  = 0.04).","['All children aged 10 to 18 years consecutively referred to the tertiary pediatric gastroenterology unit were enrolled', 'Pediatric Colonoscopy', 'One hundred twenty-three children were allocated to three age- and sex-matched groups']","['polyethylene glycol 3350 combined with bisacodyl (PEG-bisacodyl group), or polyethylene glycol 4000 with electrolytes (PEG-ELS group), or sodium picosulphate plus magnesium oxide plus citric acid (NaPico+MgCit group', 'NaPico+MgCit']","['mean BBPS score', 'minor adverse events', 'serious adverse events', 'Effectiveness, Tolerability, and Safety', 'Boston Bowel Preparation Scale (BBPS', 'Nausea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1636281', 'cui_str': 'Pediatric gastroenterology'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0724672', 'cui_str': 'POLYETHYLENE GLYCOL 3350'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",123.0,0.0726099,"Nausea was the only symptom more frequent in the PEG-ELS group compared to the NaPico+MgCit group ( p  = 0.04), and apathy was the only symptom more frequent in PEG-bisacodyl than in the NaPico+MgCit group ( p  = 0.04).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Szaflarska-Popławska', 'Affiliation': 'Department of Pediatric Endoscopy and Gastrointestinal Function Testing, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Tunowska', 'Affiliation': 'Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Sobieska-Poszwa', 'Affiliation': 'Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Krogulska', 'Affiliation': 'Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}]",Gastroenterology research and practice,['10.1155/2019/3230654']
1372,25538174,A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer.,"BACKGROUND


It is unclear whether treating brain metastasis before starting systemic chemotherapy can improve survival compared with upfront chemotherapy in non-small-cell lung cancer (NSCLC) with asymptomatic cerebral oligo-metastases.
PATIENTS AND METHODS


We undertook a randomized, controlled trial of 105 patients with one to four brain metastases, admitted to Samsung Medical Center between 2008 and 2013. Patients were randomly assigned to receive stereotactic radiosurgery (SRS) (49 patients) followed by chemotherapy or upfront chemotherapy (49 patients). The primary end point was overall survival (OS) and secondary end points included central nervous system (CNS) progression-free survival, progression to symptomatic brain metastasis and brain functional outcome.
RESULTS


The median age was 58 years (range, 29-85) with ECOG 0-1 performance status, and 40% of patients were never smokers. Most patients had adenocarcinoma, and about half of patients had only one brain metastasis, while the rest had multiple cerebral metastases. The median OS time was 14.6 months [95% confidence interval (CI), 9.2-20.0] in the SRS group and 15.3 months (95% CI, 7.2-23.4) for the upfront chemotherapy group (P = 0.418). There was no significant difference in time to CNS disease progression [median, 9.4 months (SRS) versus 6.6 months (upfront chemotherapy), P = 0.248]. Symptomatic progression of brain metastases was observed more frequently in the upfront chemotherapy group (26.5%) than the SRS group (18.4%) but without statistical significance.
CONCLUSIONS


Although this study included smaller sample size than initially anticipated due to early termination, SRS followed by chemotherapy did not improve OS in oligo-brain metastases NSCLC patients compared with upfront chemotherapy. Further study with large number of patients should be needed to confirm the use of upfront chemotherapy alone in this subgroup of patients.
CLINICAL TRIALS NUMBER


NCT01301560.",2015,"Symptomatic progression of brain metastases was observed more frequently in the upfront chemotherapy group (26.5%) than the SRS group (18.4%) but without statistical significance.
","['105 patients with one to four brain metastases, admitted to Samsung Medical Center between 2008 and 2013', 'The median age was 58 years (range, 29-85) with ECOG 0-1 performance status, and 40% of patients were never smokers', 'patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer']","['chemotherapy or upfront chemotherapy', 'upfront chemotherapy', 'stereotactic radiosurgery (SRS']","['overall survival (OS) and secondary end points included central nervous system (CNS) progression-free survival, progression to symptomatic brain metastasis and brain functional outcome', 'Symptomatic progression of brain metastases', 'median OS time', 'survival', 'time to CNS disease progression']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1137305', 'cui_str': 'oligo(caprolactone)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007682', 'cui_str': 'CNS Diseases'}]",105.0,0.146403,"Symptomatic progression of brain metastases was observed more frequently in the upfront chemotherapy group (26.5%) than the SRS group (18.4%) but without statistical significance.
","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Lim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'M-Y', 'Initials': 'MY', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'S-W', 'Initials': 'SW', 'LastName': 'Um', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Na', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Samsung Medical Center, Sunkyunkwan University School of Medicine, Seoul, Republic of Korea; Department of Biostatistics and Bioinformatics, Duke University, Durham, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'O J', 'Initials': 'OJ', 'LastName': 'Kwon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J-I', 'Initials': 'JI', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul. Electronic address: silkahn@skku.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu584']
1373,31885129,"Efficacy of ""Mentoring to Be Active"" on Weight Loss, Body Mass Index, and Body Fat among Obese and Extremely Obese Youth in Rural Appalachia.","PURPOSE


This study compares the efficacy of a behavioral skills mentoring program (Mentored Planning to Be Active [MBA]) to a teacher-led program (Planning to Be Active [PBA]) for increasing physical activity in Appalachian teens on health outcomes (weight loss, body mass index (BMI), and body fat).
METHODS


Secondary analysis of a larger group-randomized controlled trial was conducted in 20 rural Appalachian schools. Descriptive Pearson correlations and multivariate analyses with between-subject effects were conducted. Effect sizes (ES) using Cohen's d and odds ratios (OR) with 95% confidence intervals were calculated.
FINDINGS


The obese MBA group lost 77.5% more weight by T3 compared to the PBA group; T2 was (F = 8.51, P = .000) and T3 was (F = 7.62, P = .000). ES was 0.34. OR = 1.45 (95% CI: 0.558-3.792) at T2 and OR = 3.32 (95% CI: 1.103-9.978) at T3. Extremely obese in the MBA group lost 80.0% more weight compared to the PBA group; T2 was (F = 5.23, P = .025) and at T3 (F = 6.33, P = .015) ES was 0.58. OR = 4.36 (95% CI: 0.981-19.34). Extremely obese females lost more weight compared to males (F = 4.75, P = .034). BMI and body fat had similar results; youth in the MBA group had the most improvement.
CONCLUSIONS


Rural Appalachian youth are disproportionately extremely obese. BMI does not capture adiposity or cardiovascular risk. BMI, BMI percentile, raw weight, fat mass, and percent body fat are more complete analyses of adiposity and cardiovascular risk.",2020,"Extremely obese in the MBA group lost 80.0% more weight compared to the PBA group; T2 was (F = 5.23, P = .025) and at T3 (F = 6.33, P = .015) ES was 0.58.","['20 rural Appalachian schools', 'Obese and Extremely Obese Youth in Rural Appalachia', 'Appalachian teens']","['BMI', 'behavioral skills mentoring program (Mentored Planning to Be Active [MBA', 'teacher-led program (Planning to Be Active [PBA', 'Mentoring']","['BMI, BMI percentile, raw weight, fat mass, and percent body fat', 'weight', 'capture adiposity or cardiovascular risk', 'Weight Loss, Body Mass Index, and Body Fat', 'health outcomes (weight loss, body mass index (BMI), and body fat', 'BMI and body fat']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C1521910', 'cui_str': 'Teens'}]","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0744384,"Extremely obese in the MBA group lost 80.0% more weight compared to the PBA group; T2 was (F = 5.23, P = .025) and at T3 (F = 6.33, P = .015) ES was 0.58.","[{'ForeName': 'Laureen H', 'Initials': 'LH', 'LastName': 'Smith', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Petosa', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Columbus, Ohio.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12410']
1374,32424833,Atraumatic restorative treatments improve child oral health-related quality of life: A noninferiority randomized controlled trial.,"OBJECTIVES


Management of dental caries under dental general anaesthesia (DGA) in young children improves their quality of life. A randomized controlled trial was undertaken to test the changes in oral health-related quality of life among children treated under a DGA or managed using the Atraumatic Restorative Treatment and Hall crown approaches (ARTs).
METHODS


Children scheduled for a DGA for the management of dental caries after assessment at the Oral Health Centre of Western Australia were invited to participate. Inclusion and exclusion criteria were applied. Child oral health-related quality of life (COHRQoL) was evaluated through the Early Childhood Oral Health Impact Scale (ECOHIS) and the child-specific Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) at baseline and 12 months after consent. The changes in child oral health-related quality of life were analysed on an intention-to-treat basis. Paired t-test and Wilcoxon's matched-pairs rank test were used for within-group comparison and t-test, Mann-Whitney test, and test of proportions for between-group comparisons. Linear regression was used for multivariable analyses of the follow-up scores.
RESULTS


Sixty-five parents/carers agreed to participate and were randomized (Test = 32; Control = 33). Mean age = 4.7 years, SD 1.1; 51% male. At baseline, there were no statistically significant differences in age and sex between the groups; however, the ARTs group reported higher ECOHIS scores. At follow-up, both the ARTs and DGA groups had lower ECOHIS scores (20.7 vs 12.9 and 14.4 vs 13.3, respectively) and CARIES-QC scores (12.6 vs 7.1 and 9.9 vs 8.4, respectively). The within-group differences in the ARTs group were statistically significant while the differences in the DGA group were not, P < .01 and P > .05, respectively. In a linear regression of the follow-up scores, being in the DGA group increased the follow-up scores, but it was no longer statistically significant while baseline impact scores were significantly associated with greater follow-up scores for both the ECOHIS and the CARIES-QC, P < .01.
CONCLUSION


The child oral health-related quality life among children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries.",2020,"The child oral health-related quality life among children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries.","['children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries', 'young children', 'dental caries under dental', 'Mean age\xa0', 'Sixty-five parents/carers agreed to participate and were randomized ', 'children treated under a DGA or managed using the Atraumatic Restorative Treatment and Hall crown approaches (ARTs', 'Children scheduled for a DGA for the management of dental caries after assessment at the Oral Health Centre of Western Australia were invited to participate']","['general anaesthesia (DGA', 'Atraumatic restorative treatments']","['quality of life', 'lower ECOHIS scores', 'child oral health-related quality of life', 'oral health-related quality of life', 'baseline impact scores', 'CARIES-QC scores', 'higher ECOHIS scores', 'Early Childhood Oral Health Impact Scale (ECOHIS) and the child-specific Caries Impacts and Experiences Questionnaire for Children (CARIES-QC', 'Child oral health-related quality of life (COHRQoL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",65.0,0.067343,"The child oral health-related quality life among children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Dental Health Services, Perth, WA, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Forrest', 'Affiliation': 'Dental Health Services, Perth, WA, Australia.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12539']
1375,31954541,Brief interventions for improving adherence in schizophrenia: A pilot study using electronic medication event monitoring.,"Poor medication adherence remains frequent in schizophrenia. The present study examined the efficacy of two month-long pilot interventions using the Medication Event Monitoring System (MEMS®). Thirty-three outpatients at high risk for relapse were randomized to receive a smartphone-based intervention, a nurse-based intervention, or treatment as usual. All patients then used the MEMS® to objectively measure medication adherence over six months. No differences were observed in adherence measures or relapse rates across the three groups. When using electronic medication monitoring as an objective measure of adherence, easily-implemented interventions may not significantly improve adherence in patients at high risk for relapse.",2020,No differences were observed in adherence measures or relapse rates across the three groups.,"['patients at high risk for relapse', 'Thirty-three outpatients at high risk for relapse', 'schizophrenia']","['Medication Event Monitoring System (MEMS®', 'smartphone-based intervention, a nurse-based intervention, or treatment as usual']","['medication adherence', 'adherence measures or relapse rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",33.0,0.015776,No differences were observed in adherence measures or relapse rates across the three groups.,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Tessier', 'Affiliation': ""Centre Hospitalier Charles Perrens, Pole de Psychiatrie 347, 121 rue de la Bechade, Bordeaux 33076, France; CNRS-UMR 5287, Université de Bordeaux, Institut de Neurosciences Cognitives et Intégratives d'Aquitaine (INCIA), 146 rue Léo Saignat, Bordeaux 33076, France.""}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Dupuy', 'Affiliation': ""CNRS-UMR 5287, Université de Bordeaux, Institut de Neurosciences Cognitives et Intégratives d'Aquitaine (INCIA), 146 rue Léo Saignat, Bordeaux 33076, France; EA 4136-Handicap et Système Nerveux, Université de Bordeaux, 146 rue Léo Saignat, Bordeaux 33076, France.""}, {'ForeName': 'Franck Jean', 'Initials': 'FJ', 'LastName': 'Baylé', 'Affiliation': 'Hôpital Sainte-Anne, Université Paris V-Descartes, 1 Rue Cabanis, Paris 75014, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Herse', 'Affiliation': 'Centre Hospitalier Charles Perrens, Pole de Psychiatrie 347, 121 rue de la Bechade, Bordeaux 33076, France.'}, {'ForeName': 'Anne-Catherine', 'Initials': 'AC', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, University of Liège, Place du 20 Août 7, Liège 4000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Vrijens', 'Affiliation': 'Department of Public Health, University of Liège, Place du 20 Août 7, Liège 4000, Belgium; AARDEX Group, 24, Rue des Cyclistes Frontière 4600 Visé, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Schweitzer', 'Affiliation': ""CNRS-UMR 5287, Université de Bordeaux, Institut de Neurosciences Cognitives et Intégratives d'Aquitaine (INCIA), 146 rue Léo Saignat, Bordeaux 33076, France; EPHE, PSL Research University, Les Patios Saint-Jacques, 4-14 Rue Ferrus, Paris 75014, France.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Swendsen', 'Affiliation': ""CNRS-UMR 5287, Université de Bordeaux, Institut de Neurosciences Cognitives et Intégratives d'Aquitaine (INCIA), 146 rue Léo Saignat, Bordeaux 33076, France; EPHE, PSL Research University, Les Patios Saint-Jacques, 4-14 Rue Ferrus, Paris 75014, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Misdrahi', 'Affiliation': ""Centre Hospitalier Charles Perrens, Pole de Psychiatrie 347, 121 rue de la Bechade, Bordeaux 33076, France; CNRS-UMR 5287, Université de Bordeaux, Institut de Neurosciences Cognitives et Intégratives d'Aquitaine (INCIA), 146 rue Léo Saignat, Bordeaux 33076, France. Electronic address: david.misdrahi@u-bordeaux.fr.""}]",Psychiatry research,['10.1016/j.psychres.2020.112780']
1376,25343269,Teleneuropsychology: evidence for video teleconference-based neuropsychological assessment.,"The use of videoconference technology to deliver health care diagnostics and treatment continues to grow at a rapid pace. Telepsychiatry and telepsychology applications are well-accepted by patients and providers, and both diagnostic and treatment outcomes have generally been similar to traditional face-to-face interactions. Preliminary applications of videoconference-based neuropsychological assessment (teleneuropsychology) have yielded promising results in the feasibility and reliability of several standard tests, although large-scale studies are lacking. This investigation was conducted to determine the reliability of video teleconference (VTC) - based neuropsychological assessment using a brief battery of standard neuropsychological tests commonly used in the evaluation of known or suspected dementia. Tests included the Mini-Mental State Examination (MMSE), Hopkins Verbal Learning Test-Revised, Digit Span forward and backward, short form Boston Naming Test, Letter and Category Fluency, and Clock Drawing. Tests were administered via VTC and in-person to subjects, counterbalanced using alternate test forms and standard instructions. Two hundred two adult subjects were tested in both rural and urban settings, including 83 with cognitive impairment and 119 healthy controls. We found highly similar results across VTC and in-person conditions, with significant intraclass correlations (mean=.74; range: 0.55-0.91) between test scores. Findings remained consistent in subjects with or without cognitive impairment and in persons with MMSE scores as low as 15. VTC-based neuropsychological testing is a valid and reliable alternative to traditional face-to-face assessment using selected measures. More VTC-based studies using additional tests in different populations are needed to fully explore the utility of this new testing medium.",2014,VTC-based neuropsychological testing is a valid and reliable alternative to traditional face-to-face assessment using selected measures.,"['Two hundred two adult subjects were tested in both rural and urban settings, including 83 with cognitive impairment and 119 healthy controls']","['Teleneuropsychology', 'video teleconference (VTC) - based neuropsychological assessment', 'videoconference technology', 'videoconference-based neuropsychological assessment (teleneuropsychology', 'VTC-based neuropsychological testing']","['Mini-Mental State Examination (MMSE), Hopkins Verbal Learning Test-Revised, Digit Span forward and backward, short form Boston Naming Test, Letter and Category Fluency, and Clock Drawing']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0451037', 'cui_str': 'Boston Naming Test'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}]",202.0,0.0362128,VTC-based neuropsychological testing is a valid and reliable alternative to traditional face-to-face assessment using selected measures.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Munro Cullum', 'Affiliation': '1Department of Psychiatry,The University of Texas Southwestern Medical Center,Dallas,Texas.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': '3Department of Clinical Sciences,The University of Texas Southwestern Medical Center,Dallas,Texas.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grosch', 'Affiliation': '1Department of Psychiatry,The University of Texas Southwestern Medical Center,Dallas,Texas.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Parikh', 'Affiliation': '1Department of Psychiatry,The University of Texas Southwestern Medical Center,Dallas,Texas.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Weiner', 'Affiliation': '1Department of Psychiatry,The University of Texas Southwestern Medical Center,Dallas,Texas.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617714000873']
1377,24846036,Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial.,"IMPORTANCE


There is limited evidence supporting use of physical therapy for hip osteoarthritis.
OBJECTIVE


To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis.
DESIGN, SETTING, AND PARTICIPANTS


Randomized, placebo-controlled, participant- and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph. Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up (May 2010-February 2013) INTERVENTIONS: Participants attended 10 treatment sessions over 12 weeks. Active treatment included education and advice, manual therapy, home exercise, and gait aid if appropriate. Sham treatment included inactive ultrasound and inert gel. For 24 weeks after treatment, the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly.
MAIN OUTCOMES AND MEASURES


Primary outcomes were average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 no difficulty to 68 extreme difficulty) at week 13. Secondary outcomes were these measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life at weeks 13 and 36.
RESULTS


Ninety-six patients (94%) completed week 13 measurements and 83 (81%) completed week 36 measurements. The between-group differences for improvements in pain were not significant. For the active group, the baseline mean (SD) visual analog scale score was 58.8 mm (13.3) and the week-13 score was 40.1 mm (24.6); for the sham group, the baseline score was 58.0 mm (11.6) and the week-13 score was 35.2 mm (21.4). The mean difference was 6.9 mm favoring sham treatment (95% CI, -3.9 to 17.7). The function scores were not significantly different between groups. The baseline mean (SD) physical function score for the active group was 32.3 (9.2) and the week-13 score was 27.5 (12.9) units, whereas the baseline score for the sham treatment group was 32.4 (8.4) units and the week-13 score was 26.4 (11.3) units, for a mean difference of 1.4 units favoring sham (95% CI, -3.8 to 6.5) at week 13. There were no between-group differences in secondary outcomes (except greater week-13 improvement in the balance step test in the active group). Nineteen of 46 patients (41%) in the active group reported 26 mild adverse effects and 7 of 49 (14%) in the sham group reported 9 mild adverse events (P = .003).
CONCLUSIONS AND RELEVANCE


Among adults with painful hip osteoarthritis, physical therapy did not result in greater improvement in pain or function compared with sham treatment, raising questions about its value for these patients.
TRIAL REGISTRATION


anzctr.org.au Identifier: ACTRN12610000439044.",2014,"Among adults with painful hip osteoarthritis, physical therapy did not result in greater improvement in pain or function compared with sham treatment, raising questions about its value for these patients.
","['102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph', 'patients with hip osteoarthritis', 'adults with painful hip osteoarthritis']","['active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly', 'physical therapy', 'inactive ultrasound and inert gel', 'placebo']","['pain', 'baseline mean (SD) visual analog scale score', 'pain or function', 'baseline mean (SD) physical function score', 'pain and physical function', '26 mild adverse effects', 'function scores', 'average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0', 'pain and function', 'measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life', 'mild adverse events']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0029410', 'cui_str': 'Coxarthrosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551516', 'cui_str': 'Painful hips'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C2607857'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",102.0,0.270093,"Among adults with painful hip osteoarthritis, physical therapy did not result in greater improvement in pain or function compared with sham treatment, raising questions about its value for these patients.
","[{'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thorlene', 'Initials': 'T', 'LastName': 'Egerton', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'J Haxby', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Metcalf', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McManus', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Sims', 'Affiliation': 'Cricket Australia Centre of Excellence, Brisbane, Australia.'}, {'ForeName': 'Yong-Hao', 'Initials': 'YH', 'LastName': 'Pua', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore.'}, {'ForeName': 'Tim V', 'Initials': 'TV', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Centre for Health Economics, Monash University, Melbourne.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne8Department of Clinical Epidemiology, Cabrini Health, Melbourne.'}]",JAMA,['10.1001/jama.2014.4591']
1378,31870766,"Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial.","BACKGROUND


Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain.
METHODS


This multicentre, double-blind, parallel-arm, randomised controlled trial was done at 13 specialist clinics, academic centres, and hospitals in the USA. Patients with chronic, intractable pain of the back and legs (Visual Analog Scale [VAS] pain score ≥60 mm; Oswestry Disability Index [ODI] score 41-80) who were refractory to conservative therapy, on stable pain medications, had no previous experience with spinal cord stimulation, and were appropriate candidates for a spinal cord stimulation trial were screened. Eligible patients were randomly assigned (1:1) to receive ECAP-controlled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal cord stimulation (control group). The randomisation sequence was computer generated with permuted blocks of size 4 and 6 and stratified by site. Patients, investigators, and site staff were masked to the treatment assignment. The primary outcome was the proportion of patients with a reduction of 50% or more in overall back and leg pain with no increase in pain medications. Non-inferiority (δ=10%) followed by superiority were tested in the intention-to-treat population at 3 months (primary analysis) and 12 months (additional prespecified analysis) after the permanent implant. This study is registered with ClinicalTrials.gov, NCT02924129, and is ongoing.
FINDINGS


Between Feb 21, 2017, and Feb 20, 2018, 134 patients were enrolled and randomly assigned (67 to each treatment group). The intention-to-treat analysis comprised 125 patients at 3 months (62 in the closed-loop group and 63 in the open-loop group) and 118 patients at 12 months (59 in the closed-loop group and 59 in the open-loop group). The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6-37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3-37·7; p=0·0060). We observed no differences in safety profiles between the two groups. The most frequently reported study-related adverse events in both groups were lead migration (nine [7%] patients), implantable pulse generator pocket pain (five [4%]), and muscle spasm or cramp (three [2%]).
INTERPRETATION


ECAP-controlled closed-loop stimulation provided significantly greater and more clinically meaningful pain relief up to 12 months than open-loop spinal cord stimulation. Greater spinal cord activation seen in the closed-loop group suggests a mechanistic explanation for the superior results, which aligns with the putative mechanism of action for spinal cord stimulation and warrants further investigation.
FUNDING


Saluda Medical.",2020,"The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6-37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3-37·7; p=0·0060).","['patients during daily use', 'chronic back and leg pain (Evoke', 'Eligible patients', 'Patients with chronic, intractable pain of the back and legs (Visual Analog Scale [VAS] pain score ≥60 mm', 'Between Feb 21, 2017, and Feb 20, 2018, 134 patients were enrolled and randomly assigned', '13 specialist clinics, academic centres, and hospitals in the USA']","['ECAP-controlled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal cord stimulation (control group', 'therapy via recorded evoked compound action potentials (ECAPs', 'closed-loop spinal cord stimulation', 'ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation']","['pain relief', 'pain medications', 'muscle spasm or cramp', 'implantable pulse generator pocket pain', 'safety profiles', 'proportion of patients with a reduction of 50% or more in overall back and leg pain', 'meaningful pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0559530', 'cui_str': 'Open loop (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}]",134.0,0.450313,"The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6-37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3-37·7; p=0·0060).","[{'ForeName': 'Nagy', 'Initials': 'N', 'LastName': 'Mekhail', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA. Electronic address: mekhain@ccf.org.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Levy', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Deer', 'Affiliation': 'The Spine and Nerve Center of The Virginias, Charleston, WV, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Carolinas Pain Institute and Wake Forest University School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ, USA.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Amirdelfan', 'Affiliation': 'IPM Medical Group, Walnut Creek, CA, USA.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Hunter', 'Affiliation': 'Ainsworth Institute of Pain Management, New York, NY, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rosen', 'Affiliation': 'Delaware Valley Pain and Spine Institute, Trevose, PA, USA.'}, {'ForeName': 'Shrif J', 'Initials': 'SJ', 'LastName': 'Costandi', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Falowski', 'Affiliation': 'Neurosurgical Associates of Lancaster, Lancaster, PA, USA.'}, {'ForeName': 'Abram H', 'Initials': 'AH', 'LastName': 'Burgher', 'Affiliation': 'HOPE Research-TPC, Phoenix, AZ, USA.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Pope', 'Affiliation': 'Evolve Restorative Center, Santa Rosa, CA, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Gilmore', 'Affiliation': 'Center for Clinical Research, Winston-Salem, NC, USA.'}, {'ForeName': 'Farooq A', 'Initials': 'FA', 'LastName': 'Qureshi', 'Affiliation': ""St Luke's Spine & Pain Associates, Easton, PA, USA.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': 'Pain Management Associates, Independence, MO, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carlson', 'Affiliation': 'Arizona Pain, Glendale, AZ, USA.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Kim', 'Affiliation': 'The Spine and Nerve Center of The Virginias, Charleston, WV, USA.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Yang', 'Affiliation': 'Summit Pain Alliance, Santa Rosa, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stauss', 'Affiliation': 'Advanced Pain Management, Greenfield, WI, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Poree', 'Affiliation': 'University of California at San Francisco, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30414-4']
1379,25538173,Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial.,"BACKGROUND


For patients with initially unresectable liver metastases from colorectal cancer, chemotherapy can downsize metastases and facilitate secondary resection. We assessed the efficacy of bevacizumab plus modified FOLFOX-6 (5-fluorouracil/folinic acid, oxaliplatin) or FOLFOXIRI (5-fluorouracil/folinic acid, oxaliplatin, irinotecan) in this setting.
PATIENTS AND METHODS


OLIVIA was a multinational open-label phase II study conducted at 16 centres in Austria, France, Spain, and the UK. Patients with unresectable liver metastases were randomised to bevacizumab (5 mg/kg) plus mFOLFOX-6 [oxaliplatin 85 mg/m(2), folinic acid 400 mg/m(2), 5-fluorouracil 400 mg/m(2) (bolus) then 2400 mg/m(2) (46-h infusion)] or FOLFOXIRI [oxaliplatin 85 mg/m(2), irinotecan 165 mg/m(2), folinic acid 200 mg/m(2), 5-fluorouracil 3200 mg/m(2) (46-h infusion)] every 2 weeks. Unresectability was defined as ≥1 of the following criteria: no possibility of upfront R0/R1 resection of all lesions; <30% residual liver volume after resection; metastases in contact with major vessels of the remnant liver. Resectability was evaluated by multidisciplinary review. The primary end point was overall resection rate (R0/R1/R2). Efficacy end points were analysed by intention-to-treat analysis.
RESULTS


In patients assigned to bevacizumab-FOLFOXIRI (n = 41) or bevacizumab-mFOLFOX-6 (n = 39), the overall resection rate was 61% [95% confidence interval (CI) 45% to 76%] and 49% (95% CI 32% to 65%), respectively (difference 12%; 95% CI -11% to 36%). R0 resection rates were 49% and 23%, respectively. Overall tumour response rates were 81% (95% CI 65% to 91%) with bevacizumab-FOLFOXIRI and 62% (95% CI 45% to 77%) with bevacizumab-mFOLFOX-6. Median progression-free survival (PFS) was 18·6 (95% CI 12.9-22.3) months and 11·5 (95% CI 9.6-13.6) months, respectively. The most common grade 3-5 adverse events were neutropenia (bevacizumab-FOLFOXIRI, 50%; bevacizumab-mFOLFOX-6, 35%) and diarrhoea (30% and 14%, respectively).
CONCLUSIONS


Bevacizumab-FOLFOXIRI was associated with higher response and resection rates and prolonged PFS versus bevacizumab-mFOLFOX-6 in patients with initially unresectable liver metastases from colorectal cancer. Toxicity was increased but manageable with bevacizumab-FOLFOXIRI.
CLINICALTRIALSGOV


NCT00778102.",2015,Overall tumour response rates were 81% (95% CI 65% to 91%) with bevacizumab-FOLFOXIRI and 62% (95% CI 45% to 77%) with bevacizumab-mFOLFOX-6.,"['OLIVIA was a multinational open-label phase II study conducted at 16 centres in Austria, France, Spain, and the UK', 'Patients with unresectable liver metastases', 'patients with initially unresectable liver metastases from colorectal cancer']","['FOLFOXIRI [oxaliplatin 85 mg/m(2), irinotecan 165 mg/m(2), folinic acid 200 mg/m(2), 5-fluorouracil 3200 mg/m(2) (46-h infusion', 'bevacizumab', 'chemotherapy', 'Bevacizumab plus mFOLFOX-6 or FOLFOXIRI', 'bevacizumab-FOLFOXIRI', 'bevacizumab plus modified FOLFOX-6 (5-fluorouracil/folinic acid, oxaliplatin) or FOLFOXIRI (5-fluorouracil/folinic acid, oxaliplatin, irinotecan', 'bevacizumab-mFOLFOX-6', 'Bevacizumab-FOLFOXIRI', 'mFOLFOX-6 [oxaliplatin 85 mg/m(2), folinic acid 400 mg/m(2), 5-fluorouracil 400 mg/m(2) (bolus']","['Overall tumour response rates', 'overall resection rate', 'diarrhoea', 'overall resection rate (R0/R1/R2', 'response and resection rates', 'R0 resection rates', 'Median progression-free survival (PFS', 'Resectability', 'Toxicity']","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.125857,Overall tumour response rates were 81% (95% CI 65% to 91%) with bevacizumab-FOLFOXIRI and 62% (95% CI 45% to 77%) with bevacizumab-mFOLFOX-6.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gruenberger', 'Affiliation': 'Department of Surgery I, Rudolfstiftung Hospital, Vienna, Austria. Electronic address: t.gruenberger@icloud.com.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Oncology, University College London Cancer Institute, London.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Department of Medicine, The Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'García Alfonso', 'Affiliation': 'Department of Medical Oncology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rivoire', 'Affiliation': 'Department of Surgical Oncology, Léon Bérard Cancer Center, Université Claude Bernard Lyon I, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mudan', 'Affiliation': 'Department of Surgery, The Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lasserre', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hermann', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Waterkamp', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'Centre Hepato-Biliaire, AP-HP Hôpital Paul Brousse, UMR-S 776, Université Paris-Sud, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu580']
1380,31880758,Endotoxin Removal in Septic Shock with the Alteco LPS Adsorber Was Safe But Showed no Benefit Compared to Placebo in the Double-Blind Randomized Controlled Trial-the Asset Study.,"PURPOSE


Lipopolysaccharides (LPS) are presumed to contribute to the inflammatory response in sepsis. We investigated if extracorporeal Alteco LPS Adsorber for LPS removal in early gram-negative septic shock was feasible and safe. Also, effects on endotoxin level, inflammatory response, and organ function were assessed.
METHODS


A pilot, double-blinded, randomized, Phase IIa, feasibility clinical investigation was undertaken in six Scandinavian intensive care units aiming to allocate 32 septic shock patients with abdominal or urogenital focus on LPS Adsorber therapy or a Sham Adsorber, therapy without active LPS binding. The study treatment was initiated within 12 h of inclusion and given for 6 h daily on first 2 days. LPS was measured in all patients.
RESULTS


The investigation was terminated after 527 days with eight patients included in the LPS Adsorber group and seven in the Sham group. Twenty-one adverse effects, judged not to be related to the device, were reported in three patients in the LPS Adsorber group and two in the Sham group. Two patients in the Sham group and no patients in the LPS Adsorber group died within 28 days. Plasma LPS levels were low without groups differences during or after adsorber therapy. The changes in inflammatory markers and organ function were similar in the groups.
CONCLUSIONS


In a small cohort of patients with presumed gram-negative septic shock, levels of circulating endotoxin were low and no adverse effects within 28 days after LPS adsorber-treatment were observed. No benefit compared with a sham device was seen when using a LPS adsorber in addition to standard care.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02335723. Registered: November 28, 2014.",2020,"Twenty-one adverse effects, judged not to be related to the device, were reported in three patients in the LPS Adsorber group and two in the Sham group.","['six Scandinavian intensive care units aiming to allocate thirty-two septic shock patients with abdominal or urogenital focus to LPS Adsorber therapy or a Sham Adsorber, therapy without active LPS-binding']",['Placebo'],"['inflammatory markers and organ function', 'LPS', 'endotoxin level, inflammatory response and organ function', 'Plasma LPS levels']","[{'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",32.0,0.524534,"Twenty-one adverse effects, judged not to be related to the device, were reported in three patients in the LPS Adsorber group and two in the Sham group.","[{'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Lipcsey', 'Affiliation': 'Hedenstierna Laboratory, Department of Surgical Sciences/Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Tenhunen', 'Affiliation': 'Department of Surgical Sciences/Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Soeren E', 'Initials': 'SE', 'LastName': 'Pischke', 'Affiliation': 'Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kuitunen', 'Affiliation': 'Department of Intensive Care, University of Tampere and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Flaatten', 'Affiliation': 'Department of Clinical Medicine, Haukeland University Hospital, UiB Bergen, Bergen, Norway.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'De Geer', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Sjölin', 'Affiliation': 'Section of Infectious Diseases, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frithiof', 'Affiliation': 'Department of Surgical Sciences/Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Chew', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Stepani', 'Initials': 'S', 'LastName': 'Bendel', 'Affiliation': 'Department of Intensive Care, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Kawati', 'Affiliation': 'Department of Surgical Sciences/Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Section of Clinical Chemistry, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tom Eirik', 'Initials': 'TE', 'LastName': 'Mollnes', 'Affiliation': 'Department of Immunology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tor Inge', 'Initials': 'TI', 'LastName': 'Tønnessen', 'Affiliation': 'Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Rubertsson', 'Affiliation': 'Department of Surgical Sciences/Anaesthesiology and Intensive Care Medicine, Uppsala University, Uppsala, Sweden.'}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001503']
1381,24662210,Outcomes are not different for patient-matched versus nonmatched treatment in subjects with chronic recurrent low back pain: a randomized clinical trial.,"BACKGROUND CONTEXT


Classification schemas for low back pain (LBP), such as the Treatment-Based Classification and the Movement System Impairment, use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes.
PURPOSE


To assess if providing matched treatments based on patient-specific clinical features led to superior treatment outcomes compared with an unmatched treatment for subjects with chronic recurrent LBP.
STUDY DESIGN


This study is a randomized controlled trial.
PATIENT SAMPLE


Subjects (n=124) with LBP (≥12 months) with or without recurrences underwent a standardized clinical examination to group them into one of two strata: ineligible or eligible for stabilization exercises based on the Treatment-Based Classification schema. Subjects underwent additional clinical tests to assign them to one of the five possible Movement System Impairment categories.
OUTCOME MEASURES


Questionnaires were collected electronically at Week 0 (before treatment), Week 7 (after the 6-week 1-hour treatment sessions), and 12 months. Using the Oswestry disability index (0-100) and the Numeric Pain Rating Scale (0-10), the primary analysis was performed using the intention-to-treat principle. Secondary outcomes included fear-avoidance beliefs and psychosocial work-related and general health status.
METHODS


After subjects were categorized based on their particular clinical features using both the Treatment-Based Classification and Movement System Impairment schemas, they were randomized into one of two treatments using a 3:1 ratio for matched or unmatched treatments. The treatments were trunk stabilization exercise or Movement System Impairment-directed exercises.
RESULTS


Of the patients allocated to treatment for this study, 76 received a matched treatment and 25 received an unmatched treatment. After treatment, both groups showed a statistically significant improvement in the primary outcome measures and almost all the secondary measures; however, the matched treatment group did not demonstrate superior outcomes at Week 7 or 12 months, except on one of the secondary measures (Graded Chronic Pain Scale [Disability Scale]) (p=.01).
CONCLUSIONS


Providing a matched treatment based on either the Treatment-Based Classification or the Movement System Impairment classification schema did not improve treatment outcomes compared with an unmatched treatment for patients with chronic LBP, except on one secondary disability measure.",2014,"After treatment, both groups showed a statistically significant improvement in the primary outcome measures and almost all the secondary measures; however, the matched treatment group did not demonstrate superior outcomes at Week 7 or 12 months, except on one of the secondary measures (Graded Chronic Pain Scale [Disability Scale])","['SAMPLE\n\n\nSubjects (n=124) with LBP (≥12 months) with or without recurrences underwent a standardized clinical examination to group them into one of two strata: ineligible or eligible for', 'subgroup patients with LBP', 'subjects with chronic recurrent LBP', 'After subjects were categorized based on their particular clinical features using both the Treatment-Based Classification and Movement System Impairment schemas', 'subjects with chronic recurrent low back pain']","['stabilization exercises based on the Treatment-Based Classification schema', 'trunk stabilization exercise or Movement System Impairment-directed exercises']","['fear-avoidance beliefs and psychosocial work-related and general health status', 'secondary measures (Graded Chronic Pain Scale [Disability Scale', 'Numeric Pain Rating Scale', 'Oswestry disability index']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0751648', 'cui_str': 'Recurrent Low Back Pain'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",124.0,0.0482588,"After treatment, both groups showed a statistically significant improvement in the primary outcome measures and almost all the secondary measures; however, the matched treatment group did not demonstrate superior outcomes at Week 7 or 12 months, except on one of the secondary measures (Graded Chronic Pain Scale [Disability Scale])","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Henry', 'Affiliation': 'Department of Rehabilitation and Movement Science, College of Nursing and Health Science, University of Vermont, 305 Rowell Bldg, 106 Carrigan Drive, Burlington, VT 05405-0068, USA. Electronic address: sharon.henry@uvm.edu.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Van Dillen', 'Affiliation': 'Program in Physical Therapy and Department of Orthopaedic Surgery, Washington University School of Medicine, Campus Box 8502, 4444 Forest Park Avenue, St. Louis, MO 63108, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Ouellette-Morton', 'Affiliation': 'Department of Rehabilitation and Movement Science, College of Nursing and Health Science, University of Vermont, 305 Rowell Bldg, 106 Carrigan Drive, Burlington, VT 05405-0068, USA.'}, {'ForeName': 'Juvena R', 'Initials': 'JR', 'LastName': 'Hitt', 'Affiliation': 'Department of Rehabilitation and Movement Science, College of Nursing and Health Science, University of Vermont, 305 Rowell Bldg, 106 Carrigan Drive, Burlington, VT 05405-0068, USA.'}, {'ForeName': 'Karen V', 'Initials': 'KV', 'LastName': 'Lomond', 'Affiliation': 'Department of Rehabilitation and Movement Science, College of Nursing and Health Science, University of Vermont, 305 Rowell Bldg, 106 Carrigan Drive, Burlington, VT 05405-0068, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'DeSarno', 'Affiliation': 'Department of Biostatistics, College of Medicine, University of Vermont, 305 Rowell Bldg, 106 Carrigan Drive, Burlington, VT 05405-0068, USA.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'Department of Biostatistics, College of Medicine, University of Vermont, 305 Rowell Bldg, 106 Carrigan Drive, Burlington, VT 05405-0068, USA.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2014.03.024']
1382,23297639,[Effect of combined administration of bile duct decompression and lactulose in mechanical jaundice].,"AIM


Study the state of intestine microecology in patients with obstructive jaundice after decompression of bile ducts and administration of lactulose.
MATERIALS AND METHODS


58 patients of different gender and age who were under treatment in the 13th surgical department of City Clinical Hospital No. 7 due to obstructive jaundice were examined. Evaluation of lactulose administration was carried out in a blinded randomized study. The patients were divided into 2 groups of 29 individuals each: (1) patients who had undergone surgery without administration oflactulose (control) and (2) patients who had received immediately after decompression of bile ducts 30 ml of lactulose for 1 week (comparison group). Feces samples were obtained with a weekly interval for bacteriological study for dysbacteriosis.
RESULTS


Based on the results of bacteriological analysis of feces in all the 58 patients with mechanical jaundice disorders of intestine microecology of various severity degrees were detected. In the patient group who had received lactulose for 7 days after the decompression ofbile ducts a tendency for an increase ofpopulation level of bifidobacteria and lactobacilli and a decrease of quantity of opportunistic microorganisms of various taxonomical groups was noted.
CONCLUSION


Administration of lactulose to patients at 30 ml dose per day for 7 days positively affected the state of microbiocenosis of colon towards its normalization.",2012,Based on the results of bacteriological analysis of feces in all the 58 patients with mechanical jaundice disorders of intestine microecology of various severity degrees were detected.,"['patients were divided into 2 groups of 29 individuals each: (1) patients who had undergone surgery without administration oflactulose (control) and (2) patients who had received immediately after', '58 patients with mechanical jaundice disorders of intestine microecology of various severity degrees', '58 patients of different gender and age who were under treatment in the 13th surgical department of City Clinical Hospital No', 'mechanical jaundice', 'patients with obstructive jaundice after decompression of bile ducts and administration of lactulose']","['lactulose', 'bile duct decompression and lactulose', 'decompression of bile ducts 30 ml of lactulose']","['quantity of opportunistic microorganisms', 'ofpopulation level of bifidobacteria and lactobacilli', 'obstructive jaundice']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C0021831', 'cui_str': 'Intestinal Diseases'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0587503', 'cui_str': 'Surgical department (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0005400', 'cui_str': 'Bile Ducts'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}]","[{'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0005400', 'cui_str': 'Bile Ducts'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}]",58.0,0.028516,Based on the results of bacteriological analysis of feces in all the 58 patients with mechanical jaundice disorders of intestine microecology of various severity degrees were detected.,"[{'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Rabaev', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Bekbaurov', 'Affiliation': ''}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Fialkina', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1383,32492981,Impact of CD56 Continuously Recognizable as Prognostic Value of Acute Promyelocytic Leukemia: Results of Multivariate Analyses in the Japan Adult Leukemia Study Group (JALSG)-APL204 Study and a Review of the Literature.,"BACKGROUND


After long-term analysis of the JALSG-APL204 study we recently reported that maintenance therapy with tamibarotene was more effective than all-trans retinoic acid (ATRA) by reducing relapse in APL patients. Here, the clinical significance of other important prognostic factors was evaluated with multivariate analyses.
PATIENTS AND METHODS


Newly diagnosed acute promyelocytic leukemia (APL) patients were registered with the study. Induction was composed of ATRA and chemotherapy. Patients who achieved molecular remission after consolidation were randomly assigned to maintenance with tamibarotene or ATRA.
RESULTS


Of the 344 eligible patients, 319 (93%) achieved complete remission (CR). After completing consolidation, 269 patients underwent maintenance random assignment-135 to ATRA, and 134 to tamibarotene. By multivariate analysis, overexpression of CD56 in blast was an independent unfavorable prognostic factor for relapse-free survival (RFS) ( p  = 0.006) together with more than 10.0 × 10 9 /L WBC counts ( p  = 0.001) and the ATRA arm in maintenance ( p  = 0.028). Of all phenotypes, CD56 was related most clearly to an unfavorable prognosis. The CR rate, mortality rate during induction and overall survival of CD56 +  APL were not significantly different compared with CD56 -  APL. CD56 is continuously an independent unfavorable prognostic factor for RFS in APL patients treated with ATRA and chemotherapy followed by ATRA or tamibarotene maintenance therapy.",2020,"The CR rate, mortality rate during induction and overall survival of CD56 +  APL were not significantly different compared with CD56 -  APL.","['Acute Promyelocytic Leukemia', 'Patients who achieved molecular remission after consolidation', 'Newly diagnosed acute promyelocytic leukemia (APL) patients were registered with the study', 'Japan Adult Leukemia Study Group ', '269 patients underwent maintenance random assignment-135 to ATRA, and 134 to tamibarotene']","['tamibarotene or ATRA', 'CD56', 'tamibarotene']","['CR rate, mortality rate during induction and overall survival of CD56 +  APL', 'relapse-free survival (RFS', 'WBC counts', 'complete remission (CR']","[{'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C1567753', 'cui_str': 'tamibarotene'}]","[{'cui': 'C1567753', 'cui_str': 'tamibarotene'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",344.0,0.133671,"The CR rate, mortality rate during induction and overall survival of CD56 +  APL were not significantly different compared with CD56 -  APL.","[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Takeshita', 'Affiliation': 'Transfusion and Cell Therapy, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, Higashiku 431-3192, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Asou', 'Affiliation': 'International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka 350-1298, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Atsuta', 'Affiliation': 'The Japanese Data Center for Hematopoietic Cell Transplantation, 1-1-20 Taikou-minami, Higashiku, Nagoya 461-0047, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Furumaki', 'Affiliation': 'Transfusion and Cell Therapy, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, Higashiku 431-3192, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sakura', 'Affiliation': 'Hematology, Saiseikai Maebashi Hospital, 564-1, Kamishindenmachi, Maebashi 371-0821, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Hematology/Oncology, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki 710-8602, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sawa', 'Affiliation': 'Hematology and Oncology, Anjo Kosei Hospital, 28 Higashikurokute, Anjochou, Anjo 446-8602, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Dobashi', 'Affiliation': 'Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8, Nishisinbashi, Minatoku, Tokyo 105-8461, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Hematology and Rheumatology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Ohsakasayama 589-8511, Japan.'}, {'ForeName': 'Rikio', 'Initials': 'R', 'LastName': 'Suzuki', 'Affiliation': 'Hematology and Oncology, Tokai University School of Medicine, 143 Shimokasuya, Isahara 259-1193, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Hematology and Rheumatology, Nihon University School of Medicine, 30-1 Ohyaguchikamichou, Itabashiku, Tokyo 173-8610, Japan.'}, {'ForeName': 'Shigehisa', 'Initials': 'S', 'LastName': 'Tamaki', 'Affiliation': 'Hematology, Japanese Red Cross Ise Hospital, 1-471-2 Funae, Ise 516-8512, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Hagihara', 'Affiliation': 'Hematology and Clinical Immunology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawaku, Yokohama 236-0004, Japan.'}, {'ForeName': 'Katsumichi', 'Initials': 'K', 'LastName': 'Fujimaki', 'Affiliation': 'Hematology, Fujisawa City Hospital, 2-6-1 Fujisawa, Fujisawa 251-8550, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minamiguchi', 'Affiliation': 'Hematology, Shiga University of Medical Science, Seta-Tsukinowa, Otsu 520-2192, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Hematology, Saiseikai Yokohama Nanbu Hospital, 3-2-10 Kounandai, Kounanku, Yokohama 234-0054, Japan.'}, {'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Yanada', 'Affiliation': 'Hematology and Cell Therapy, Aichi Cancer Center, 1-1 Kanokoden, Chikusaku, Nagoya 464-8681, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Hematology, Oncology and Respiratory Medicine, Okayama University Medical School, 2-5-1 Shikatachou, Kitaku, Okayama 700-8558, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Usui', 'Affiliation': 'Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8, Nishisinbashi, Minatoku, Tokyo 105-8461, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'National Cancer Center Hospital, 5-1-1 Tsukiji, Chuouku, Tokyo 104-0045, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kiyoi', 'Affiliation': 'Hematology and Oncology, Nagoya University Graduate School of Medicine, 65 Tsurumaichou, Showaku, Nagoya 466-8550, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Ohtake', 'Affiliation': 'Kanazawa University, Kakumamachi, Kanazawa 920-1192, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Hematology and Rheumatology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Ohsakasayama 589-8511, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Naoe', 'Affiliation': 'National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Nakaku, Nagoya 460-0001, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Hematology, Atomic Bomb Institute, Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan.'}, {'ForeName': 'The Japan Adult Leukemia Study', 'Initials': 'TJALS', 'LastName': 'Group', 'Affiliation': 'JALSG office, 3-6-35 Nishiki, Nakaku, Nagoya 460-0003, Japan.'}]",Cancers,['10.3390/cancers12061444']
1384,23210356,[Combined physiobalneotherapy of vibration disease associated with dyscirculatory encephalopathy in the miners].,"The present study included 161 patients with vibration disease associated with dyscirculatory encephalopathy. It was designed to estimate the degree of cognitive dysfunction and the efficacy of its treatment by physiobalneotherapeutic techniiques including low-frequency pulsed currents in combination with general artificial sodium chloride and iodine bromide baths. In addition, the influence of combined therapy on the clinical course of the disease, results of neuropsychological tests, and cerebral hemodynamics was evaluated.",2012,It was designed to estimate the degree of cognitive dysfunction and the efficacy of its treatment by physiobalneotherapeutic techniiques including low-frequency pulsed currents in combination with general artificial sodium chloride and iodine bromide baths.,['161 patients with vibration disease associated with dyscirculatory encephalopathy'],['general artificial sodium chloride and iodine bromide baths'],"['neuropsychological tests, and cerebral hemodynamics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340685', 'cui_str': 'Vibration syndrome (disorder)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathies'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0063752', 'cui_str': 'iodobromine'}, {'cui': 'C0150141'}]","[{'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",161.0,0.0165989,It was designed to estimate the degree of cognitive dysfunction and the efficacy of its treatment by physiobalneotherapeutic techniiques including low-frequency pulsed currents in combination with general artificial sodium chloride and iodine bromide baths.,"[{'ForeName': 'Iu M', 'Initials': 'IuM', 'LastName': 'Borzunova', 'Affiliation': 'Ekaterinburg Medical Research Centre of Prophylaxis and Health Promotion in the Employees\nof Industrial Enterprises of Russian Federal Consumer Rights Protection and Human Health Control Agency, Ekaterinburg, Russia'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Fedorov', 'Affiliation': 'Ural State Medical Academy of Russian Ministry of Health and Social Development, Ekaterinburg, Russia'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",[]
1385,32418217,The impact of a modified electronic probe tip design on patient perception of discomfort during periodontal probing using standardized probing force: A randomized controlled trial.,"AIMS


This study evaluated pain associated with electronic probing comparing two commercially available probe tip designs using standardized force.
MATERIAL AND METHODS


Twenty adult patients with slight-moderate chronic periodontitis received periodontal probing using controlled-force electronic probe at 2 visits. In visit 1, a random arch was probed with either a ball-end (0.6 mm diameter, 408 kPa; Test) or straight (0.45 mm diameter, 726 kPa; Control) probe tip. The opposing arch was then probed using the other probe tip. Discomfort associated with each probing episode was recorded using visual analogue scale (VAS). 7 days later, tip assignments were alternated from visit 1 and VAS re-scored. VAS scores were compared by probe tip, arches and visits.
RESULTS


Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p = .3713). However, the straight tip was associated with decreased VAS scores in the maxilla (p = .01). Overall, VAS values did not differ by arch or study visit. Individual VAS scores showed high levels of correlation between study visits and between tips used (R 2   = .86 and 0.64, respectively, p < .0001).
CONCLUSIONS


Both probing approaches were associated with low levels of pain on probing. The straight tip may be perceived as more comfortable in the maxilla.",2020,"RESULTS


Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p=0.3713).",['Twenty adult patients with slight-moderate chronic periodontitis received periodontal probing using controlled-force electronic probe at 2 visits'],['modified electronic probe tip design'],"['visual analogue scale (VAS', 'patient perception of discomfort', 'VAS scores', 'Individual VAS scores', 'Overall, VAS values']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0339407,"RESULTS


Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p=0.3713).","[{'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Harrison', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stuhr', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Shaddox', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}]",Journal of clinical periodontology,['10.1111/jcpe.13308']
1386,31367742,Omadacycline for Acute Bacterial Skin and Skin Structure Infections.,"BACKGROUND


Within the last decade, methicillin-resistant Staphylococcus aureus (MRSA) has emerged as a frequent cause of purulent skin and soft tissue infections. New therapeutic options are being investigated for these infections.
METHODS


We report an integrated analysis of 2 randomized, controlled studies involving omadacycline, a novel aminomethylcycline, and linezolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Omadacycline in Acute Skin and Skin Structure Infections Study 1 (OASIS-1) initiated patients on intravenous omadacycline or linezolid, with the option to transition to an oral formulation after day 3. OASIS-2 was an oral-only study of omadacycline versus linezolid.
RESULTS


In total, 691 patients received omadacycline and 689 patients received linezolid. Infection types included wound infection in 46.8% of patients, cellulitis/erysipelas in 30.5%, and major abscess in 22.7%. Pathogens were identified in 73.2% of patients. S. aureus was detected in 74.7% and MRSA in 32.4% of patients in whom a pathogen was identified. Omadacycline was noninferior to linezolid using the Food and Drug Administration primary endpoint of early clinical response (86.2% vs 83.9%; difference 2.3, 95% confidence interval -1.5 to 6.2) and using the European Medicines Agency primary endpoint of investigator-assessed clinical response at the posttreatment evaluation. Clinical responses were similar across different infection types and infections caused by different pathogens. Treatment-emergent adverse events, mostly described as mild or moderate, were reported by 51.1% of patients receiving omadacycline and 41.2% of those receiving linezolid.
CONCLUSIONS


Omadacycline was effective and safe in ABSSSI.
CLINICAL TRIALS REGISTRATION


NCT02378480 and NCT02877927.",2019,S. aureus was detected in 74.7% and MRSA in 32.4% of patients in whom a pathogen was identified.,"['691 patients received', 'Acute Skin and Skin Structure Infections Study 1 (OASIS-1) initiated patients on intravenous', 'acute bacterial skin and skin structure infections (ABSSSI']","['omadacycline versus linezolid', 'Omadacycline', 'linezolid', 'omadacycline', 'omadacycline or linezolid', 'omadacycline, a novel aminomethylcycline, and linezolid']","['early clinical response', 'wound infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}]","[{'cui': 'C2983838', 'cui_str': 'omadacycline'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}]",691.0,0.0383841,S. aureus was detected in 74.7% and MRSA in 32.4% of patients in whom a pathogen was identified.,"[{'ForeName': 'Fredrick M', 'Initials': 'FM', 'LastName': 'Abrahamian', 'Affiliation': 'Department of Emergency Medicine, Olive View-UCLA Medical Center, Sylmar.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sakoulas', 'Affiliation': 'Division of Host-Microbe Systems and Therapeutics, Center for Immunity, Infection and Inflammation, University of California San Diego School of Medicine, La Jolla.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Tzanis', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manley', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Steenbergen', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stats Consulting, Guerneville, California.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'McGovern', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz396']
1387,31542988,"Age-Related Differences in Medication Adherence, Symptoms, and Stigma in Poorly Adherent Adults With Bipolar Disorder.","OBJECTIVE


We present a secondary analysis of data reporting differences in medication adherence, psychiatric symptom severity, and internalized stigma levels in older (age ≥ 55 years) versus younger (age < 55 years) adults with bipolar disorder (BD) and poor medication adherence.
METHODS


Data used for this analysis came from 184 participants in a National Institute of Mental Health-funded randomized controlled trial, comparing a customized adherence enhancement (CAE) intervention intended to promote BD medication adherence with a BD-specific educational program (EDU). At screen, study participants were ≥20% nonadherent with BD medications as measured by the Tablets Routine Questionnaire (TRQ). Psychiatric symptoms, functional status, and internalized stigma were measured using validated scales.
RESULTS


Older adults had significantly lower anxiety disorder comorbidity ( P  < .01 for 1 or more anxiety disorders), depressive symptom severity scores ( P  = .011), and self-stigma scores ( P  = .001) compared to their younger counterparts. In the analyses evaluating change over time in TRQ between older and younger participants by treatment arm (ie, CAE and EDU), there was a significant finding of interaction between time, age-group, and treatment arm ( P  = .007).
CONCLUSIONS


Older adults may be less anxious and depressed, with less self-stigma, compared to younger people with BD and poor adherence. With respect to medication adherence, older individuals in EDU appear to do less well than younger individuals over time.",2020,"RESULTS


Older adults had significantly lower anxiety disorder comorbidity ( P  < .01 for 1 or more anxiety disorders), depressive symptom severity scores ( P  = .011), and self-stigma scores ( P  = .001) compared to their younger counterparts.","['Older adults', 'older (age ≥ 55 years) versus younger (age < 55 years) adults with bipolar disorder (BD) and poor medication adherence', '184 participants in a National Institute of Mental Health-funded randomized controlled trial']",['customized adherence enhancement (CAE) intervention intended to promote BD medication adherence with a BD-specific educational program (EDU'],"['medication adherence, psychiatric symptom severity, and internalized stigma levels', 'anxiety disorder comorbidity', 'anxiety disorders), depressive symptom severity scores', 'Psychiatric symptoms, functional status, and internalized stigma', 'self-stigma scores', 'Tablets Routine Questionnaire (TRQ', 'Medication Adherence, Symptoms, and Stigma']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0027466', 'cui_str': 'National Institute of Mental Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",184.0,0.0551426,"RESULTS


Older adults had significantly lower anxiety disorder comorbidity ( P  < .01 for 1 or more anxiety disorders), depressive symptom severity scores ( P  = .011), and self-stigma scores ( P  = .001) compared to their younger counterparts.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Smilowitz', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Awais', 'Initials': 'A', 'LastName': 'Aftab', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Aebi', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Tatsuoka', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719874116']
1388,31870188,KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma.,"Patients with high-risk stage II melanoma are at significant risk for recurrence after surgical resection. Adjuvant treatment options to lower the risk for distant metastases are limited. Although adjuvant IFN-α2b is associated with improved relapse-free survival in patients with high-risk melanoma, toxicity and limited overall survival benefits limit its use. Adjuvant treatment with the PD-1 inhibitor pembrolizumab significantly improved recurrence-free survival, compared with placebo, in patients with resected stage III melanoma in the Phase III KEYNOTE-054 trial; efficacy in patients with stage II disease has not been established. This article describes the design and rationale of KEYNOTE-716 (NCT03553836), a two-part, randomized, placebo-controlled, multicenter Phase III study of adjuvant pembrolizumab in patients with surgically resected high-risk stage II melanoma. Clinical trial registry & ID: ClinicalTrials.gov, NCT03553836.",2020,"Although adjuvant IFN-α2b is associated with improved relapse-free survival in patients with high-risk melanoma, toxicity and limited overall survival benefits limit its use.","['patients with stage II disease', 'resected high-risk stage II melanoma', 'patients with surgically resected high-risk stage II melanoma', 'patients with resected stage III melanoma', 'Patients with high-risk stage II melanoma']","['placebo', 'pembrolizumab', 'adjuvant pembrolizumab', 'PD-1 inhibitor pembrolizumab']","['recurrence-free survival', 'relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.518572,"Although adjuvant IFN-α2b is associated with improved relapse-free survival in patients with high-risk melanoma, toxicity and limited overall survival benefits limit its use.","[{'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Luke', 'Affiliation': 'Cancer Immunotherapeutics Center, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA\xa015232, USA.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale,"" Naples, Italy.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Department of Medical Oncology, Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Gershenwald', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Department of Dermatology and Skin Cancers, Hôpital de la Timone, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatological Oncology, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Cancer Immunotherapeutics Center, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA\xa015232, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Department of Dermatology, Elbe Kliniken Buxtehude, Buxtehude, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Dermatology Unit, Department of Oncology, Gustave Roussy Cancer Centre, Villejuif, France.'}, {'ForeName': 'Merrick', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Scolyer', 'Affiliation': 'Melanoma Institute Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Yoon', 'Affiliation': 'Department of Surgical Oncology, Dana-Farber Cancer Institute, Boston, MA\xa002215, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Poklepovic', 'Affiliation': 'Department of Internal Medicine, VCU Massey Cancer Center, Richmond, VA 23298, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, NJ\xa007033, USA.'}, {'ForeName': 'Sama', 'Initials': 'S', 'LastName': 'Ahsan', 'Affiliation': 'Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, NJ\xa007033, USA.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, NJ\xa007033, USA.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'M Eggermont', 'Affiliation': 'Dermatology Unit, Department of Oncology, Gustave Roussy Cancer Centre, Villejuif, France.'}]","Future oncology (London, England)",['10.2217/fon-2019-0666']
1389,31758920,Comparative pharmacokinetic estimates of drospirenone alone and in combination with ethinyl estradiol after single and repeated oral administration in healthy females.,"OBJECTIVE


To determine the pharmacokinetics (PK) of drospirenone (DRSP), alone versus in combination with ethinyl estradiol (EE), after single and repeated administration.
STUDY DESIGN


We conducted a single-centre, open-label, crossover, 2-treatment, 2-period, 2-sequence study in which non-micronized DRSP 4 mg or a combination of DRSP 3 mg and EE 0.02 mg were administered to healthy female subjects on day 1 to obtain a single-dose kinetic profile, and from day 4 to day 15 to obtain a repeated-dose kinetic profile. The maximum observed concentration (C max ) and area under the concentration/time curve (AUC) were determined in a model-independent way using non dose corrected data. Statistical analysis was based on a parametric method (ANOVA-log).
RESULTS


A total of 24 healthy female subjects were randomized 1:1 into the study. The mean relative, non-dose-corrected PK estimates after single-dose administration for the endpoints AUC (0-72h) , AUC (0-24h)  and C max  were 543.5 ng*h/mL, 296.1 ng*h/mL and 27.3 ng/mL for DRSP alone, and 442.0 ng*h/mL, 264.7 ng*h/mL and 37.5 ng/mL for the DRSP/EE combination; p < 0.001. The mean relative, non-dose-corrected PK estimates after repeated dose administration for the endpoints AUC (0-72h) , AUC (0-24h)  and C max  were 1066.8 ng*h/ml, 570.2 ng*h/mL and 41.0 ng/mL for DRSP alone, and 1394.5 ng*h/mL, 732.8 ng*h/mL and 61.4 ng/mL for the DRSP/EE combination; p < 0.001.
CONCLUSIONS


DRSP alone exhibits a lower accumulation ratio than together with EE. The extent of systemic exposure at steady-state is about 32% less with the new formulation (AUC (0-24h) , steady-state geometric mean ratio: 77.8%; 90% confidence interval: 74.6%-81.1%). This PK profile may be caused by EE.
IMPLICATIONS


Our results suggest that metabolic pathways of DRSP can be inhibited by EE resulting in higher DRSP plasma concentrations in DRSP/EE formulations than in a DRSP-alone formulation. The enzymes CYP3A4 and SULT1A1 may play a role. Additional drug-drug-interaction studies are needed to better understand these metabolic pathways and their future clinical implications.",2020,"The extent of systemic exposure at steady-state is about 32% less with the new formulation (AUC (0-24h) , steady-state geometric mean ratio: 77.8%; 90% confidence interval: 74.6%-81.1%).","['healthy females', '24 healthy female subjects', 'healthy female subjects']","['micronized DRSP 4 mg or a combination of DRSP 3 mg and EE', 'ethinyl estradiol', 'drospirenone (DRSP), alone versus in combination with ethinyl estradiol (EE', 'DRSP', 'drospirenone']","['mean relative, non-dose-corrected PK estimates', 'DRSP plasma concentrations', 'accumulation ratio', 'maximum observed concentration (C max ) and area under the concentration/time curve (AUC']","[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",24.0,0.107105,"The extent of systemic exposure at steady-state is about 32% less with the new formulation (AUC (0-24h) , steady-state geometric mean ratio: 77.8%; 90% confidence interval: 74.6%-81.1%).","[{'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Richter', 'Affiliation': 'CCDRD AG, Germany. Electronic address: wrichter@ccdrdag.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Koytchev', 'Affiliation': 'CCDRD AG, Germany. Electronic address: rkoytchev@ccdrdag.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kirkov', 'Affiliation': 'MHAT Tokuda Hospital, Bulgaria. Electronic address: v.kirkov@mail.bg.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merki', 'Affiliation': 'Klinik für Reproduktions-Endokrinologie, Universitäts Spital Zürich, Switzerland. Electronic address: gabriele.merki@usz.ch.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis Healthcare, Germany. Electronic address: enrico.colli@exeltis.com.'}, {'ForeName': 'P-A', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Healthcare, Germany. Electronic address: pedro-antonio.regidor@exeltis.com.'}]",Contraception,['10.1016/j.contraception.2019.10.005']
1390,24591201,Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study.,"This randomized, noninferiority (NI), global, phase 3 study evaluated the efficacy and safety of bendamustine plus rituximab (BR) vs a standard rituximab-chemotherapy regimen (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] or rituximab plus cyclophosphamide, vincristine, and prednisone [R-CVP]) for treatment-naive patients with indolent non-Hodgkin's lymphoma or mantle cell lymphoma. Investigators preassigned the standard treatment regimen they considered most appropriate for each patient; patients were randomized to receive BR (n = 224) or standard therapy (R-CHOP/R-CVP, n = 223) for 6 cycles; 2 additional cycles were permitted at investigator discretion. Response was assessed by a blinded independent review committee. BR was noninferior to R-CHOP/R-CVP, as assessed by the primary end point of complete response rate (31% vs 25%, respectively; P = .0225 for NI [0.88 margin]). The overall response rates for BR and R-CHOP/R-CVP were 97% and 91%, respectively (P = .0102). Incidences of vomiting and drug-hypersensitivity reactions were significantly higher in patients treated with BR (P < .05), and incidences of peripheral neuropathy/paresthesia and alopecia were significantly higher in patients treated with standard-therapy regimens (P < .05). These data indicate BR is noninferior to standard therapy with regard to clinical response with an acceptable safety profile. This trial was registered at www.clinicaltrials.gov as #NCT00877006.",2014,"Incidences of vomiting and drug-hypersensitivity reactions were significantly higher in patients treated with BR (P < .05), and incidences of peripheral neuropathy/paresthesia and alopecia were significantly higher in patients treated with standard-therapy regimens (P < .05).","[""treatment-naive patients with indolent non-Hodgkin's lymphoma or mantle cell lymphoma""]","['MCL', 'standard therapy', 'bendamustine-rituximab or R-CHOP/R-CVP', 'bendamustine plus rituximab (BR) vs a standard rituximab-chemotherapy regimen (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] or rituximab plus cyclophosphamide, vincristine, and prednisone [R-CVP']","['efficacy and safety', 'incidences of peripheral neuropathy/paresthesia and alopecia', 'complete response rate', 'Incidences of vomiting and drug-hypersensitivity reactions', 'overall response rates for BR and R-CHOP/R-CVP']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0013182', 'cui_str': 'Drug Allergy'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0659196,"Incidences of vomiting and drug-hypersensitivity reactions were significantly higher in patients treated with BR (P < .05), and incidences of peripheral neuropathy/paresthesia and alopecia were significantly higher in patients treated with standard-therapy regimens (P < .05).","[{'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN;'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van der Jagt', 'Affiliation': ''}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Tim E', 'Initials': 'TE', 'LastName': 'Hawkins', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macdonald', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hertzberg', 'Affiliation': ''}, {'ForeName': 'Yiu-Lam', 'Initials': 'YL', 'LastName': 'Kwan', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Kolibaba', 'Affiliation': ''}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Issa', 'Affiliation': ''}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Clementi', 'Affiliation': ''}, {'ForeName': 'Doreen M', 'Initials': 'DM', 'LastName': 'Hallman', 'Affiliation': ''}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Munteanu', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Burke', 'Affiliation': ''}]",Blood,['10.1182/blood-2013-11-531327']
1391,32492913,"Effects of Monomeric and Oligomeric Flavanols on Kidney Function, Inflammation and Oxidative Stress in Runners: A Randomized Double-Blind Pilot Study.","Nonsteroidal anti-inflammatory drugs are frequently used by athletes in order to prevent musculoskeletal pain and improve performance. In combination with strenuous exercise, they can contribute to a reduction of renal blood flow and promote development of kidney damage. We aimed to investigate whether monomeric and oligomeric flavanols (MOF) could reduce the severity of kidney injuries associated with the intake of 400-mg ibuprofen followed by the completion of a half-marathon in recreational athletes. In this double-blind, randomized study, the original MOF blend of extracts from grape seeds ( Vitis vinifera  L.) and pine bark ( Pinus pinaster  L.) or placebo were taken for 14 days preceding the ibuprofen/half-marathon. Urine samples were collected before and after the ibuprofen/half-marathon, and biomarkers of kidney injury, inflammation and oxidative stress were assessed. Intake of MOF significantly reduced the incidence of post-race hematuria ( p =  0.0004) and lowered concentrations of interleukin (IL)-6 in the urine ( p =  0.032). Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde tended to decrease. The supplementation with MOF in recreational runners appears to safely preserve kidney function, reduce inflammation and promote antioxidant defense during strenuous exercise and intake of a single dose of ibuprofen.",2020,"Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde tended to decrease.","['recreational runners', 'recreational athletes', 'Runners']","['strenuous exercise', 'monomeric and oligomeric flavanols (MOF', 'Monomeric and Oligomeric Flavanols', '400-mg ibuprofen', 'ibuprofen', 'placebo']","['Kidney Function, Inflammation and Oxidative Stress', 'incidence of post-race hematuria', 'Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde', 'lowered concentrations of interleukin (IL)-6', 'biomarkers of kidney injury, inflammation and oxidative stress', 'renal blood flow and promote development of kidney damage']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",,0.218245,"Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde tended to decrease.","[{'ForeName': 'Khrystyna O', 'Initials': 'KO', 'LastName': 'Semen', 'Affiliation': 'Campus Venlo, Faculty of Science and Engineering, Maastricht University, 5911 BV Venlo, The Netherlands.'}, {'ForeName': 'Antje R', 'Initials': 'AR', 'LastName': 'Weseler', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Health, Medicine, and Life Sciences, Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Marcel J W', 'Initials': 'MJW', 'LastName': 'Janssen', 'Affiliation': 'Department of Clinical Chemistry and Haematology, VieCuri Medical Center Noord Limburg, 5912 BL Venlo, The Netherlands.'}, {'ForeName': 'Marie-José', 'Initials': 'MJ', 'LastName': 'Drittij-Reijnders', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Health, Medicine, and Life Sciences, Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Jos L M L', 'Initials': 'JLML', 'LastName': 'le Noble', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Health, Medicine, and Life Sciences, Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Aalt', 'Initials': 'A', 'LastName': 'Bast', 'Affiliation': 'Campus Venlo, Faculty of Science and Engineering, Maastricht University, 5911 BV Venlo, The Netherlands.'}]",Nutrients,['10.3390/nu12061634']
1392,23297638,[Change of proinflammatory cytokine profile in human intestine in dysbacteriosis caused by the antibiotics therapy].,"AIM


Study of the proinflammatory cytokines level in human gut of adults with intestinal dysbacterioses (ID).
MATERIALS AND METHODS


It is surveyed the out-patient 110 adult with torpid clinical form of enteric infection. All of patients received antibiotics of a wide spectrum of action. Patients were randomized into two groups by 55 in each. Studying of structure of gut microflora with use of differential-diagnostic media and criteria of an estimation dysbiotic infringements according to Russian Federation Standard ""Protocol of patient management. Intestine dysbacterioses"" (2003). Also defined quantity of IL-1beta, IL-6 and INF-gamma in coprofiltrates by ELISA (""Vector-Best"", Russia).
RESULTS


By comparison of positive tests proinflammatory cytokines in coprofiltratis and the gut dysbiosis expression (ID) it was revealed that the most adverse variant of revealing IL-6 in any combinations with tested cytokines in 57,2 +/- 4,7% cases. Similar cases were characterized subcompensated and decompensated gut dysbacteriosis in 65 +/- 4,5% and 100% of cases. Compensated (subclinical) form of ID revealed at patients, in coprofiltratis which INF-gamma was detected without of combinations with IL-6.
CONCLUSION


Testing of proinflammatory cytokines in coprofiltrates of individuals in ID may be one of the prognosis criteria of inflammatory reactions course duration and evaluation of therapeutic effect of disordered microbiocenosis correction.",2012,"Compensated (subclinical) form of ID revealed at patients, in coprofiltratis which INF-gamma was detected without of combinations with IL-6.
CONCLUSION


Testing of proinflammatory cytokines in coprofiltrates of individuals in ID may be one of the prognosis criteria of inflammatory reactions course duration and evaluation of therapeutic effect of disordered microbiocenosis correction.","['human gut of adults with intestinal dysbacterioses (ID', 'It is surveyed the out-patient 110 adult with torpid clinical form of enteric infection', 'coprofiltratis and the gut dysbiosis expression (ID']",[],"['quantity of IL-1beta, IL-6 and INF-gamma']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1536021', 'cui_str': 'Disbacteriosis'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",[],"[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}]",110.0,0.0322792,"Compensated (subclinical) form of ID revealed at patients, in coprofiltratis which INF-gamma was detected without of combinations with IL-6.
CONCLUSION


Testing of proinflammatory cytokines in coprofiltrates of individuals in ID may be one of the prognosis criteria of inflammatory reactions course duration and evaluation of therapeutic effect of disordered microbiocenosis correction.","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Aleshukina', 'Affiliation': ''}, {'ForeName': 'É A', 'Initials': 'ÉA', 'LastName': 'Iagovkin', 'Affiliation': ''}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Bondarenko', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1393,32035854,Randomized Trial of a Virtual Reality Tool to Teach Surgical Technique for Tibial Shaft Fracture Intramedullary Nailing.,"INTRODUCTION


Active learning methods have accumulated popularity due to improved results in knowledge acquisition as opposed to passive learning methods. For surgical resident physicians with limited training opportunities outside of the operating room due to time constraints, virtual reality (VR) is a relatively inexpensive and time-efficient active training method for procurement of surgical skills. We conducted a simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs as a more effective modality of learning orthopedic surgical techniques compared to passive learning tools such as a standard guide (SG) through trained novice medical students performing a SawBones simulation of intramedullary nail fixation.
MATERIALS AND METHODS


First and second-year medical students without prior experience of procedure were recruited and randomized to SG or VR training. Participants were observed performing simulated tibia IMN procedure immediately after training and evaluated by a blinded attending surgeon using procedure-specific checklist and 5-point global assessment scale. Participants returned after 2-weeks for repeat training and evaluation.
RESULTS


20 participants were recruited and randomized into VR (n = 10) and SG (n = 10) groups. All 20 participants completed the first phase and 17 completed the second phase of the study. Aggregate global assessment scores were significantly higher for VR than SG group (17.5 vs. 7.5, p < 0.001), including scores in all individual categories. The percentage of steps completed correctly was significantly higher in the VR group compared to the SG group (63% vs. 25%, p < 0.002). Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
DISCUSSION


VR training was more effective than a passive SG in our model of simulated tibia IMN for novice medical students. Virtual reality training may be a useful method to augment orthopedic education.",2020,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","['20 participants', 'novice medical students', 'trained novice medical students performing a SawBones simulation of intramedullary nail fixation', 'All 20 participants completed the first phase and 17 completed the second phase of the study', 'First and second-year medical students without prior experience of procedure', 'Tibial Shaft Fracture Intramedullary Nailing']","['VR training', 'Virtual Reality Tool to Teach Surgical Technique', 'simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs', 'Virtual reality training', 'SG or VR training', 'SG']","['Aggregate global assessment scores', 'percentage of steps completed correctly']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",20.0,0.0186146,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Blumstein', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: gblumstein@mednet.ucla.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zukotynski', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Cevallos', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Ishmael', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Zoller', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Burke', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Clarkson', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bernthal', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nelson F', 'Initials': 'NF', 'LastName': 'SooHoo', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.01.002']
1394,25916294,[Clinical study on Rituximab in the treatment of idiopathic thrombotic thrombocytopenic purpura].,"OBJECTIVE


To study the efficacy and safety of rituximab (RTX) in the treatment of idiopathic thrombotic thrombocytopenic purpura (ITTP).
METHODS


Among 17 ITTP patients, nine cases of the RTX group were administrated with RTX plus plasma exchange (PEX) and steroids. Eight cases of the control group received PEX plus steroids±other immune inhibitors. Patients received RTX 375 mg/m², 1 per week for 4 weeks. The laboratory parameters, including hemogram, LDH, ADAMTS13 activities and its inhibitors, and the ratio of B lymphocytes in peripheral blood were monitored. The number of PEX, total plasma volumes, remission time, relapse ratio and adverse effects in both groups were compared.
RESULTS


The median number of PEX/median total plasma volumes in the RTX and control group were 5(2-8)/9.6(4.0-15.4) L and 6(4-9)/11.2(7.5-14.6) L, respectively. Patients in the RTX and control group achieved hematologic remission at the median time of 15(5-20) days and 22(7-36) days, respectively. And the median time of immunological remission in the two groups was 2(2-8) and 2(2-4) weeks, respectively. ADAMTS13 activities increased significantly after 2 weeks in both two groups. There was no relapse in the RTX group, while 4 patients relapsed in the control group. The percentage of B lymphocytes in peripheral blood obviously deduced one week after first dose of RTX infusion compared with the level before treatment [(2.19±5.11)% vs (18.39±7.15)%, P<0.001], and began to gradually increase 9 months later. Severe adverse events were not observed in RTX group during the therapeutic procedure and follow-up, but one patient, who had sustained immunologic remission, died of severe pneumonia 7 months later.
CONCLUSION


In the treatment of ITTP, RTX in conjunction with PEX and steroids appeared to be a safe and effective therapy, with fast and sustained remission in hematology and even in immunology, with lower relapse rate and less adverse effects. But patients needed to be paid attention to prevent and treat infectious events in time.",2015,"Patients in the RTX and control group achieved hematologic remission at the median time of 15(5-20) days and 22(7-36) days, respectively.","['Among 17 ITTP patients', 'idiopathic thrombotic thrombocytopenic purpura (ITTP', 'idiopathic thrombotic thrombocytopenic purpura']","['ITTP, RTX', 'ADAMTS13', 'rituximab (RTX', 'Rituximab', 'RTX', 'RTX plus plasma exchange (PEX) and steroids', 'PEX plus steroids±other immune inhibitors']","['median time of immunological remission', 'Severe adverse events', 'sustained immunologic remission, died of severe pneumonia', 'percentage of B lymphocytes in peripheral blood', 'median number of PEX/median total plasma volumes', 'hemogram, LDH, ADAMTS13 activities and its inhibitors, and the ratio of B lymphocytes in peripheral blood', 'hematologic remission', 'number of PEX, total plasma volumes, remission time, relapse ratio and adverse effects', 'activities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2584778', 'cui_str': 'Moschowitz syndrome'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}, {'cui': 'C0200631', 'cui_str': 'Complete blood count without differential (procedure)'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0304921,"Patients in the RTX and control group achieved hematologic remission at the median time of 15(5-20) days and 22(7-36) days, respectively.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, 100th Hospital of PLA, Suzhou 215007, China.'}, {'ForeName': 'Tianqin', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, 100th Hospital of PLA, Suzhou 215007, China.'}, {'ForeName': 'Hongshi', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Hematology, 100th Hospital of PLA, Suzhou 215007, China.'}, {'ForeName': 'Chuanlu', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Hematology, 100th Hospital of PLA, Suzhou 215007, China.'}, {'ForeName': 'Haifei', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, 100th Hospital of PLA, Suzhou 215007, China.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'She', 'Affiliation': 'Department of Hematology, 100th Hospital of PLA, Suzhou 215007, China.'}, {'ForeName': 'Zhaoyue', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, 100th Hospital of PLA, Suzhou 215007, China.'}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2015.04.012']
1395,23320544,Decrease of postprandial endothelial dysfunction by spice mix added to high-fat hamburger meat in men with Type 2 diabetes mellitus.,"AIMS


Consumption of a high-fat diet has been demonstrated to promote endothelial dysfunction, possibly through an increase in lipid peroxidation and decrease in serum nitric oxide. The present study was designed to investigate whether consumption of a hamburger cooked with a polyphenol-rich spice mixture will reduce postprandial lipid oxidation and endothelial dysfunction in men with Type 2 diabetes.
METHODS


Twenty-two subjects consumed burgers cooked with salt only (control burger) or with salt and spice mix (spice burger) in randomized order. The postprandial concentration of urinary malondialdehyde and nitrate/nitrite as well as the peripheral arterial tonometry score were determined.
RESULTS


Eighteen subjects completed the study. Postprandial serum glucose, insulin and triglyceride concentrations were similar in all subjects after control burger or spice burger consumption. Urine malondialdehyde excretion in mmol/g creatinine was reduced by 31% (P < 0.001) after consuming the spice burger compared with the control burger. Two hours after consumption of the burgers, the peripheral arterial tonometry score was significantly different between control burger consumption (-9.7 ± 21.5%) and spice burger consumption (+18.0 ± 42.4%) (P = 0.025). Mean urinary nitrate/nitrite concentrations in urine collected during the 6 h after consumption of the control burger was 9.09 ± 5.7 mmol/g creatinine, but 12.37 ± 7.00 mmol/g creatinine after the spice burger (P = 0.053).
CONCLUSION


Adding a spice mix to hamburger meat prior to cooking resulted in a reduction in urinary malondialdehyde, an increase in urinary nitrate/nitrite and improvement of postprandial endothelial dysfunction in men with Type 2 diabetes. Therefore, cooking a hamburger with a polyphenol-rich spice mixture may lead to potential cardiovascular benefits in patients with Type 2 diabetes mellitus.",2013,"Postprandial serum glucose, insulin and triglyceride concentrations were similar in all subjects after control burger or spice burger consumption.","['patients with Type 2 diabetes mellitus', 'Eighteen subjects completed the study', 'men with Type 2 diabetes', 'Twenty-two subjects', 'men with Type 2 diabetes mellitus']","['polyphenol-rich spice mixture', 'consumed burgers cooked with salt only (control burger) or with salt and spice mix (spice burger']","['spice burger consumption', 'urinary nitrate/nitrite and improvement of postprandial endothelial dysfunction', 'Urine malondialdehyde excretion in mmol/g creatinine', 'Postprandial serum glucose, insulin and triglyceride concentrations', 'serum nitric oxide', 'postprandial endothelial dysfunction', 'peripheral arterial tonometry score', 'postprandial concentration of urinary malondialdehyde and nitrate/nitrite as well as the peripheral arterial tonometry score', 'Mean urinary nitrate/nitrite concentrations', 'lipid peroxidation', 'postprandial lipid oxidation and endothelial dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0037910', 'cui_str': 'Spices'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0452929', 'cui_str': 'Burger (substance)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}]","[{'cui': 'C0037910', 'cui_str': 'Spices'}, {'cui': 'C0452929', 'cui_str': 'Burger (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0042037'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]",22.0,0.0202185,"Postprandial serum glucose, insulin and triglyceride concentrations were similar in all subjects after control burger or spice burger consumption.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Henning', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rahnama', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zerlin', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thames', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Heber', 'Affiliation': ''}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.12120']
1396,32418538,The impact of a cartoon character on adults perceptions of Children's breakfast cereals: a randomized experiment.,"BACKGROUND


Cartoon characters on processed food packaging increase the perception of product preference among children, but their effect among adults has rarely been examined. We evaluated the effect of a cartoon character on breakfast cereals on beliefs about buying them for children, as well as whether demographic characteristics modified this effect.
METHODS


An experimental study was conducted with adults from online consumer panels in Mexico (n = 3755). Participants were randomly assigned to a ""cartoon"" condition (n = 1789), in which they viewed a breakfast cereal box with a Minion character on the front of the package, or the ""control"" condition (n = 1966), in which the same cereal box was displayed with no character on the package. Participants were asked: ""Is this a good cereal to buy children?"" with the response options ""Yes"", ""No"", or ""Don't know"". Multinomial adjusted logistic models regressed responses to this question (Yes = 0, No = 1, 2 = Don't know) on experimental condition. Differences in the effect of the cartoon character across demographic characteristics were tested by introducing multiplicative interaction terms.
RESULTS


The adjusted model showed that participants in the ""cartoon character"" condition were 1.67 (1.45-1.94) times more likely to consider the cereal as being ""Not good to buy for children"" than those in the control condition (p < 0.001). This effect was smaller among parents (RRR = 1.39, 1.13-1.72) compared to those without children (RRR = 2.01, 1.63-2.47). No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
CONCLUSION


Among this sample of Mexican adults, a cereal with a cartoon character on the packaging was more often perceived as ""not good to buy for children"" compared to a cereal without it. This effect was smaller among parents, potentially due to children influences of parental decisions during food purchasing.",2020,"No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
","[""adults perceptions of Children's breakfast cereals"", 'adults from online consumer panels in Mexico (n\u2009=\u20093755']","['cartoon"" condition (n\u2009=\u20091789), in which they viewed a breakfast cereal box with a Minion character on the front of the package, or the ""control"" condition', 'cartoon character', 'cartoon character on breakfast cereals']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0482463,"No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Contreras-Manzano', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Jáuregui', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico. alejandra.jauregui@insp.mx.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nieto', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vargas-Meza', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Thrasher', 'Affiliation': 'Population Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Illescas-Zárate', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Demography, ANU College of Arts and Social Sciences, The Australian National University, 9 Fellows Road Acton ACT, Canberra, 260, Australia.'}]",Nutrition journal,['10.1186/s12937-020-00565-5']
1397,24000594,"[Reactogenicity, safety, immunogenicity and prophylactic effectiveness of polysaccharide pneumococcus vaccine during immunization of HIV-infected patients].","AIM


Study safety, reactogenicity, immunogenicity and prophylactic effectiveness of polysaccharide pneumococcus vaccines during immunization of adult HIV-infected patients.
MATERIALS AND METHODS


200 HIV-infected patients at stages 3 to 4A of the disease aged 20 to 50 years with the quantity of CD4+ T-lymphocytes in blood of no less than 500 microl(-1) took part in the study. 100 individuals immunized with polysaccharide 23-valent pneumococcus vaccine (Pneumo 23, Sanofi Pasteur, France) constituted the observation group. 100 individuals not immunized against pneumococcus infection constituted the comparison group. The groups were standardized by sex, age and disease stage. Vaccine reactogenicity was evaluated by detection of general and local postvaccination reactions, degree of their intensity and duration. Vaccine safety was evaluated based on comparative evaluation of results of general clinical and biochemical studies of blood, general urine analysis, determination of IgE in blood sera, CD4+ T-lymphocytes level, quantity of HIV RNA (viral load) before vaccination and 28 days after the immunization. Vaccine immunogenicity was evaluated by determination in blood sera of IgG against a mixture of Streptococcus pneumoniae polysaccharides comprising Pneumo 23. Prophylaxis effectiveness of the preparation was evaluated by juxtaposition of acute respiratory illness morbidity in observation and control groups.
RESULTS


During immunization of HIV-infected patients against pneumococcus infection postvaccination complications, severe local and general postvaccination reactions were not detected, laboratory studies carried out before and after the immunization gave evidence on the lack of progression of the main disease and activization of the infectious process. After the immunization the geometric mean antibody titer against S. pneumoniae increased by 2 times and reached protective level. Index of prophylactic effectiveness of Pneumo 23 vaccines during immunization of HIV-positive patients was 5.6, and relative risk of the disease in the immunized group--0.07, in the control group--0.42.
CONCLUSION


The data provided give evidence on the high prophylactic effect of vaccination of immune compromised HIV-positive patients with a lack of deterioration of the main disease course.",2013,After the immunization the geometric mean antibody titer against S. pneumoniae increased by 2 times and reached protective level.,"['HIV-infected patients', '100 individuals immunized with', '200 HIV-infected patients at stages 3 to 4A of the disease aged 20 to 50 years with the quantity of CD4+ T-lymphocytes in blood of no less than 500 microl(-1) took part in the study', 'adult HIV-infected patients', '100 individuals not immunized against pneumococcus infection constituted the comparison group']","['polysaccharide pneumococcus vaccines', 'polysaccharide 23-valent pneumococcus vaccine (Pneumo 23, Sanofi Pasteur, France) constituted the observation group', 'polysaccharide pneumococcus vaccine']","['geometric mean antibody titer against S. pneumoniae', 'Index of prophylactic effectiveness', 'Vaccine safety', 'Vaccine reactogenicity', 'reactogenicity, immunogenicity and prophylactic effectiveness', 'blood, general urine analysis, determination of IgE in blood sera, CD4+ T-lymphocytes level, quantity of HIV RNA (viral load', 'Reactogenicity, safety, immunogenicity and prophylactic effectiveness', 'Vaccine immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0039215', 'cui_str': 'CD4-Positive Lymphocytes'}, {'cui': 'C0005768'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1608615', 'cui_str': 'Pneumo-23'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005768'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0039215', 'cui_str': 'CD4-Positive Lymphocytes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4277607', 'cui_str': 'Antigenicity, Vaccine'}]",100.0,0.0685549,After the immunization the geometric mean antibody titer against S. pneumoniae increased by 2 times and reached protective level.,"[{'ForeName': 'I V', 'Initials': 'IV', 'LastName': ""Fel'dblium"", 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Nikolenko', 'Affiliation': ''}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': ""Vorob'eva"", 'Affiliation': ''}, {'ForeName': 'É S', 'Initials': 'ÉS', 'LastName': 'Ivanova', 'Affiliation': ''}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': ""Shmagel'"", 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Khafizov', 'Affiliation': ''}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Iurganova', 'Affiliation': ''}, {'ForeName': 'S Ia', 'Initials': 'SIa', 'LastName': 'Zverev', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1398,32422685,A randomized clinical trial of a group cognitive-behavioral therapy to reduce alcohol use among human immunodeficiency virus-infected outpatients in western Kenya.,"BACKGROUND AND AIMS


Culturally relevant and feasible interventions are needed to address limited professional resources in sub-Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive-behavioral therapy (CBT) intervention to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya.
DESIGN


Randomized clinical trial.
SETTING


A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration.
PARTICIPANTS


A total of 614 HIV-infected outpatients [312 CBT; 302 healthy life-styles (HL); 48.5% male; mean age: 38.9 years; mean education 7.7 years] who reported a minimum of hazardous or binge drinking.
INTERVENTION AND COMPARATOR


A culturally adapted six-session gender-stratified group CBT intervention compared with HL education, each delivered by paraprofessionals over six weekly 90-minute sessions with a 9-month follow-up.
MEASUREMENTS


Primary outcome measures were percentage of drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the time-line follow-back from baseline to 9 months post-intervention. Exploratory analyses examined unprotected sex and number of partners.
FINDINGS


Median attendance was six sessions across condition. Retention at 9 months post-intervention was high and similar by condition: CBT 86% and HL 83%. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period, PDD - CBT = 3.64 (0.696), HL = 5.72 (0.71), mean difference 2.08, 95% confidence interval (CI) = 0.13 - 4.04; DDD - CBT = 0.66 (0.96), HL = 0.98 (0.098), mean difference = 0.31, 95% CI = 0.05 - 0.58. Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
CONCLUSIONS


A cognitive-behavioral therapy intervention was more efficacious than healthy lifestyles education in reducing alcohol use among HIV-infected Kenyan outpatient drinkers.",2020,"Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
","['A total of 614 HIV-infected outpatients (312 CBT; 302 HL; 48.5% male; mean age: 38.9 years; mean education 7.7 years) who reported a minimum of hazardous or binge drinking', 'HIV-infected Kenyan outpatient drinkers', 'HIV-infected outpatients in Eldoret, Kenya', 'A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration', 'human immunodeficiency virus-infected out-patients in western Kenya']","['CBT intervention compared with Healthy Lifestyles education (HL', 'cognitive-behavioral therapy intervention', 'cognitive-behavioral therapy (CBT) intervention', 'group cognitive-behavioral therapy']","['Risky sex', 'PDD and DDD marginal means', 'percent drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the Timeline Followback']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}]",614.0,0.0372522,"Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Papas', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Benson N', 'Initials': 'BN', 'LastName': 'Gakinya', 'Affiliation': 'School of Medicine, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Mwaniki', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Keter', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Klein', 'Affiliation': 'Right Response LLC, Minneapolis, MN, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Loxley', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Sidle', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schlaudt', 'Affiliation': 'Lutheran World Foundation, Gore, Chad.'}, {'ForeName': 'Tobista', 'Initials': 'T', 'LastName': 'Nafula', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Omodi', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Joyce B', 'Initials': 'JB', 'LastName': 'Baliddawa', 'Affiliation': 'School of Medicine, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Kinyanjui', 'Affiliation': 'School of Medicine, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15112']
1399,23014566,Bortezomib and dexamethasone consolidation following risk-adapted melphalan and stem cell transplantation for patients with newly diagnosed light-chain amyloidosis.,"To improve the efficacy of risk-adapted melphalan (MEL) in patients with amyloidosis (AL), we conducted a phase II trial using bortezomib and dexamethasone (BD) as consolidation. Forty untreated patients with renal (70%), cardiac (65%), liver/gastrointestinal (15%) or nervous system (13%) AL were assigned MEL 100, 140 or 200 mg/m(2) based on age, renal function and cardiac involvement. Hematological response was assessed at 3 months post stem cell transplant (SCT); patients with less than complete hematological response (CR) received BD consolidation. Four patients with advanced cardiac AL died within 100 days of SCT (10% treatment-related mortality). Survival at 12 and 24 months post treatment start was 88 and 82% overall and was 81 and 72% in patients with cardiac AL. At 3 months post SCT, 45% had ≥ partial response (PR) including 27% CR. Twenty-three patients received consolidation and in 86% response improved; all patients responded in one cycle. At 12 and 24 months, 79 and 60% had ≥ PR, 58 and 40% CR. Organ responses occurred in 55 and 70% at 12 and 24 months. Eight patients relapsed/progressed. One patient with serologic progression had organ impairment at time of progression. In newly diagnosed AL, BD following SCT rapidly and effectively improves responses resulting in high CR rates and maintained organ improvement.",2013,Survival at 12 and 24 months post treatment start was 88 and 82% overall and was 81 and 72% in patients with cardiac AL.,"['patients with amyloidosis (AL', 'Forty untreated patients with renal (70%), cardiac (65%), liver/gastrointestinal (15%) or nervous system (13', 'patients with newly diagnosed light-chain amyloidosis']","['risk-adapted melphalan (MEL', 'SCT', 'bortezomib and dexamethasone (BD', 'Bortezomib and dexamethasone consolidation following risk-adapted melphalan and stem cell transplantation']","['Survival', 'partial response (PR', 'Organ responses', 'Hematological response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027763', 'cui_str': 'Nervous System'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",40.0,0.0304213,Survival at 12 and 24 months post treatment start was 88 and 82% overall and was 81 and 72% in patients with cardiac AL.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Landau', 'Affiliation': 'Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. landau@mskcc.org'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hassoun', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Rosenzweig', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Flombaum', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bello', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hoover', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Riedel', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': ''}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Comenzo', 'Affiliation': ''}]",Leukemia,['10.1038/leu.2012.274']
1400,32421854,"A phase II, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of VT-1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail.","BACKGROUND


Onychomycosis is a fungal disease that affects the fingernails and toenails and is predominantly caused by dermatophytes. VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of lanosterol demethylase, and has demonstrated potent activity against Trichophyton rubrum and Trichophyton mentagrophytes.
OBJECTIVES


To evaluate the safety and efficacy of four dosing regimens of orally administered VT-1161 compared with placebo in patients with moderate-to-severe distal and lateral subungual onychomycosis of the toenail.
METHODS


This was a phase II, randomized, double-blind, placebo-controlled, multicentre study (ClinicalTrials.gov identifier NCT02267356). Patients aged 18-70 years (n = 259) who had 25-75% mycotic involvement were randomized to five treatment groups. They received 300 mg VT-1161 as a 2-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks, or 600 mg VT-1161 as a 2-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks. All treatments were followed by a nontreatment period of 36 weeks. A matching placebo arm was included.
RESULTS


In the intent-to-treat population, at week 48 the complete cure rates were 0% in the placebo group and ranged from 32% to 42% in the VT-1161 treatment groups (P < 0·001 vs. placebo). VT-1161 was well tolerated, with no evidence of an adverse effect on liver function or QT intervals.
CONCLUSIONS


VT-1161 treatment led to high nail clearance rates and a favourable safety profile. VT-1161 exhibits characteristics that appear promising for the treatment of this chronic and difficult-to-treat condition and warrants further evaluation in larger studies.",2020,"VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of the lanosterol demethylase, and has demonstrated potent activity against T. rubrum and T. mentagrophytes.
","['patients with moderate to severe distal and lateral subungual onychomycosis of the toenail', 'Patients aged 18-70 years (n=259) who had ≥25% to ≤75% mycotic involvement', 'patients with distal and lateral subungual onychomycosis of the toenail']","['VT-1161 oral tablets', 'placebo']","['nail clearance rates', 'efficacy and safety', 'safety and efficacy', 'complete cure rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1274513', 'cui_str': 'Distal and lateral subungual onychomycosis'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4043593', 'cui_str': 'VT-1161'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.272912,"VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of the lanosterol demethylase, and has demonstrated potent activity against T. rubrum and T. mentagrophytes.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': 'Department of Dermatology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Viamet Pharmaceuticals Inc., Durham, NC, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Degenhardt', 'Affiliation': 'Viamet Pharmaceuticals Inc., Durham, NC, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Curelop', 'Affiliation': 'Viamet Pharmaceuticals Inc., Durham, NC, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pollak', 'Affiliation': 'Endeavor Clinical Trials, San Antonio, TX, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schotzinger', 'Affiliation': 'Viamet Pharmaceuticals Inc., Durham, NC, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tavakkol', 'Affiliation': 'Viamet Pharmaceuticals Inc., Durham, NC, USA.'}]",The British journal of dermatology,['10.1111/bjd.19224']
1401,32423235,The Effects of Listening to Music on Breast Milk Production by Mothers of Premature Newborns in the Neonatal Intensive Care Unit: A Randomized Controlled Study.,"Objective:  This study was a randomized controlled experiment to determine the effects of listening to music on breast milk production in Turkish mothers with premature newborns.  Methods:  The study consisted of two groups of randomly selected mothers ( n  = 20 each) of newborns in the neonatal intensive care unit (NICU) of two university hospitals in Istanbul between November 2017 and November 2018. On the first day, all mothers were provided with training for milking with pumps. On the second through fourth days, mothers in the music group (MG) underwent two sessions of milking with music and a pump for 15 minutes at 11:00 and 16:00; the mothers in the control group underwent two sessions of milking without music. To evaluate stress levels, Spielberger's State-Trait Anxiety Inventory was administered and salivary cortisol tests were taken on the first and final days of the study.  Results:  The mean age of participants was 28.5 ± 5.3 years, the mean gestational week was 32.21 ± 2.26, and the mean birth weight of the newborns was 1748 ± 533.4 g. The state and total anxiety scores of the MG were statistically low ( p  < 0.05). There was no difference between the MG and control group in the amount of breast milk produced; however, the final test cortisol levels of the MG group were significantly lower compared with the pretest measurements ( p  < 0.05).  Conclusion:  Listening to music in the NICU while breastfeeding can help reduce stress levels in mothers to premature newborns and support breast milk production.",2020,"There was no difference between the MG and control group in the amount of breast milk produced; however, the final test cortisol levels of the MG group were significantly lower compared with the pretest measurements ( p  < 0.05).  ","['The mean age of participants was 28.5\u2009±\u20095.3 years, the mean gestational week was 32.21\u2009±\u20092.26, and the mean birth weight of the newborns was 1748\u2009±\u2009533.4', 'mothers to premature newborns', 'Turkish mothers with premature newborns', 'randomly selected mothers ( n \u2009=\u200920 each) of newborns in the neonatal intensive care unit (NICU) of two university hospitals in Istanbul between November 2017 and November 2018', 'Mothers of Premature Newborns in the Neonatal Intensive Care Unit']","['listening to music', 'Listening to Music']","['breast milk production', ""stress levels, Spielberger's State-Trait Anxiety Inventory"", 'stress levels', 'final test cortisol levels', 'state and total anxiety scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0362383,"There was no difference between the MG and control group in the amount of breast milk produced; however, the final test cortisol levels of the MG group were significantly lower compared with the pretest measurements ( p  < 0.05).  ","[{'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Varişoğlu', 'Affiliation': 'Depertmant of Nursing, Faculty of Health Science, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Ilkay', 'Initials': 'I', 'LastName': 'Güngör Satilmiş', 'Affiliation': ""İlkay Güngör Satilmiş's Institution, Florence Nightingale Faculty of Nursing, Istanbul University Cerrahpasa, Istanbul, Turkey.""}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0027']
1402,22730101,"Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study.","BACKGROUND


Bone metastases are common in patients with advanced non-small-cell lung cancer (NSCLC) and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes.
PATIENTS AND METHODS


This study evaluated whether zoledronic acid (ZOL) delayed disease progression or recurrence in patients with controlled stage IIIA/B NSCLC after first-line therapy. Patients received vitamin D and calcium supplementation and were randomized to i.v. ZOL (every 3-4 weeks) or no treatment (control). The primary end point was progression-free survival (PFS).
RESULTS


No significant intergroup differences were observed in PFS or overall survival (OS). Median PFS was 9.0 months with ZOL versus 11.3 months for control. Fifteen ZOL-treated (6.6%) and 19 control patients (9.0%) developed bone metastases. Estimated 1-year OS was 81.8% for each group. ZOL safety profile was consistent with previous clinical data, but with higher discontinuations versus control. Fifteen ZOL-treated (6.6%) and five control patients (2.3%) had renal adverse events. Two cases of osteonecrosis of the jaw were reported.
CONCLUSIONS


ZOL did not significantly affect PFS or OS in stage IIIA/B NSCLC patients with controlled disease, with a trend toward worsening PFS in the longer-term follow-up. Few patients experienced bone metastases, possibly limiting the potential ZOL impact on disease course.",2012,No significant intergroup differences were observed in PFS or overall survival (OS).,"['patients with controlled stage IIIA/B NSCLC after first-line therapy', 'patients with advanced non-small-cell lung cancer (NSCLC', 'patients with stage IIIA/B NSCLC']","['ZOL', 'Zoledronic acid', 'zoledronic acid (ZOL', 'vitamin D and calcium supplementation']","['PFS or overall survival (OS', 'renal adverse events', 'ZOL safety profile', 'bone metastases', 'Median PFS', 'PFS or OS', 'Estimated 1-year OS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0845329,No significant intergroup differences were observed in PFS or overall survival (OS).,"[{'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Torino, Italy. Electronic address: giorgio.scagliotti@unito.it.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kosmidis', 'Affiliation': 'Department of Oncology, Hygeia Hospital, Athens, Greece.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'Pulmonary Oncological Unit, San Camillo Hospital, Rome, Italy.'}, {'ForeName': 'A J M', 'Initials': 'AJM', 'LastName': 'Schreurs', 'Affiliation': ""Department of Pulmonary Diseases, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Albert', 'Affiliation': 'Department of Pulmonology, Mátrai Gyógyintézet, Mátraháza, Hungary.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Engel-Riedel', 'Affiliation': 'Department of Medical Oncology, Lung Clinic Merheim, Cologne, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schallier', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barbera', 'Affiliation': 'Department of Medical Oncology, Mariano Santo Hospital, Cosenza, Italy.'}, {'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Kuo', 'Affiliation': 'Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sallo', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Perez', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Manegold', 'Affiliation': 'Department of Surgery, University Medical Center Mannheim, Heidelberg University, Mannheim, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds128']
1403,31539295,Negative Hyperselection of Patients With  RAS  and  BRAF  Wild-Type Metastatic Colorectal Cancer Who Received Panitumumab-Based Maintenance Therapy.,"PURPOSE


We assessed the prognostic/predictive role of primary tumor sidedness and uncommon alterations of anti-epidermal growth factor receptor (EGFR) primary resistance (primary resistance in  RAS  and  BRAF  wild-type metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with  RAS / BRAF  wild-type (wt) metastatic colorectal cancer (mCRC) who were randomly assigned to panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino trial (ClinicalTrials.gov identifier: NCT02476045).
PATIENTS AND METHODS


This prespecified retrospective analysis included 199 evaluable patients with  RAS / BRAF  wt. The PRESSING panel included the following: immunohistochemistry (IHC) and in situ hybridization for  HER2/MET  amplification, IHC with or without RNA sequencing for  ALK/ROS1/NTRKs/RET  fusions, next-generation sequencing for  HER2 / PIK3CAex.20/PTEN / AKT1  and  RAS  mutations with low mutant allele fraction, and multiplex polymerase chain reaction for microsatellite instability. PRESSING status (any positive biomarker  v  all negative) and sidedness were correlated with overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) in the study population and by treatment arm.
RESULTS


Overall, left- and right-sided tumors were 85.4% and 14.6%, respectively, and PRESSING-negative and -positive tumors were 75.4% and 24.6%, respectively. At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062). Similar results were observed in the PRESSING-positive versus PRESSING-negative subgroup for ORR (59.2%  v  75.3%;  P  = .030), PFS (7.7  v  12.1 months;  P  < .001), and OS (2-year rate: 48.1%  v  68.1%;  P  = .021). The PFS benefit of FU plus LV added to panitumumab maintenance, reported in the study, was independent from sidedness and PRESSING status (interaction for PFS  P  = .293 and .127, respectively). However, outcomes were extremely poor in patients who received single-agent panitumumab and had right-sided tumors (median PFS, 7.7 months; 2-year OS, 38.5%) or PRESSING-positive tumors (median PFS, 7.4 months; 2-year OS, 47.0%).
CONCLUSION


The combined assessment of sidedness and molecular alterations of anti-EGFR primary resistance identified a consistent proportion of patients with  RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs.",2019,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062).","['199 evaluable patients with  RAS / BRAF  wt', 'Patients With  RAS  and  BRAF  Wild-Type Metastatic Colorectal Cancer', 'patients with  RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs', 'metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with  RAS / BRAF  wild-type (wt) metastatic colorectal cancer (mCRC']","['Panitumumab-Based Maintenance Therapy', 'panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino']","['Overall, left- and right-sided tumors', 'overall response rate (ORR), progression-free survival (PFS), and overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",199.0,0.168706,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062).","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Humanitas Cancer Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Murialdo', 'Affiliation': 'University of Genoa and IRCCS Azienda Ospedaliera Universitaria (AOU) San Martino-IST, Genoa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sartore-Bianchi', 'Affiliation': 'Niguarda Cancer Center, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Azienda Socio-Sanitaria Territoriale Ospedale di Cremona, Cremona, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Racca', 'Affiliation': 'AOU Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Adamo', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Annunziata', 'Initials': 'A', 'LastName': 'Gloghini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Busico', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Palermo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milione', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01254']
1404,22396446,Prognostic impact of meningeal dissemination in primary CNS lymphoma (PCNSL): experience from the G-PCNSL-SG1 trial.,"BACKGROUND


We evaluated the frequency and prognostic impact of meningeal dissemination (MD) in immunocompetent adult patients with primary central nervous system lymphoma treated in a randomized phase III trial.
PATIENTS AND METHODS


MD was evaluated at study entry and defined by lymphoma proof in the meningeal compartment detected by at least one of the following methods: cerebrospinal fluid (CSF) cytomorphology, detection of clonal B cells by IgH PCR in CSF or contrast enhancement of the leptomeninges on magnetic resonance imaging (MRI).
RESULTS


Data on MD were available in 415 patients, of those, MD was detected in 65 (15.7%): in 44/361 (12.2%) by CSF cytomorphology, in 16/152 (10.5%) by PCR and in 17/415 (4.1%) by MRI. Major patients' characteristics and therapy did not significantly differ between patients with MD (MD+) versus those without MD (MD-). There was a significant correlation of MD with CSF pleocytosis (>5/μl; P < 0.0001), but no correlation with CSF protein elevation (>45 mg/dl). Median progression-free survival was 6.7 months [95% confidence interval (CI) 0-14.5] in MD+ and 8.3 months (5.7-10.8) in MD- patients (P = 0.95); median overall survival was 21.5 months (95% CI 16.8-26.1) and 24.9 months (17.5-32.3), respectively (P = 0.98).
CONCLUSION


MD was detected infrequently and had no impact on outcome in this trial.",2012,"Median progression-free survival was 6.7 months [95% confidence interval (CI) 0-14.5] in MD+ and 8.3 months (5.7-10.8) in MD- patients (P = 0.95); median overall survival was 21.5 months (95% CI 16.8-26.1) and 24.9 months (17.5-32.3), respectively (P = 0.98).
","['immunocompetent adult patients with primary central nervous system lymphoma', 'MD was evaluated at study entry and defined by lymphoma proof in the meningeal compartment detected by at least one of the following methods: cerebrospinal fluid (CSF) cytomorphology, detection of clonal B cells by IgH PCR in CSF or contrast enhancement of the leptomeninges on magnetic resonance imaging (MRI', 'primary CNS lymphoma (PCNSL']",[],"['median overall survival', 'MD', 'Median progression-free survival', 'CSF protein elevation', 'MD with CSF pleocytosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0007807'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0228126', 'cui_str': 'Leptomeninges structure'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0201943', 'cui_str': 'Protein, spinal fluid'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0151857', 'cui_str': 'Pleocytosis'}]",,0.3046,"Median progression-free survival was 6.7 months [95% confidence interval (CI) 0-14.5] in MD+ and 8.3 months (5.7-10.8) in MD- patients (P = 0.95); median overall survival was 21.5 months (95% CI 16.8-26.1) and 24.9 months (17.5-32.3), respectively (P = 0.98).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Korfel', 'Affiliation': 'Department of Hematology & Oncology, Campus Benjamin Franklin, Charite Berlin, Berlin, Germany. Electronic address: agnieszka.korfel@charite.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland; Department of Neurology, University Hospital Tuebingen, Tuebingen.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute of Biostatistics, University Tuebingen, Tuebingen; Institute of Biostatistics, University Hospital Tuebingen, Tuebingen.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Roth', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland; Department of Neurology, University Hospital Tuebingen, Tuebingen.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Klasen', 'Affiliation': 'Department of Hematology & Oncology, Pius Hospital, Oldenburg.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roeth', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, Essen.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rauch', 'Affiliation': 'Department of Hematology & Oncology, Evangelisches Krankenhaus Bielefeld, Bielefeld.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Hematology & Oncology, Klinikum Bremen Mitte, Bremen.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fischer', 'Affiliation': 'Department of Hematology & Oncology, University of Magdeburg, Magdeburg.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hundsberger', 'Affiliation': 'Department of Hematology & Oncology, University Hospital Mainz, Mainz, Germany; Department of Neurology, Cantonal Hospital, St Gallen, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leithäuser', 'Affiliation': 'Department of Hematology & Oncology, University Hospital Rostock, Rostock.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Birnbaum', 'Affiliation': 'Department of Neurology, University Hospital Grosshadern, Munich.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kirchen', 'Affiliation': 'Department of Hematology & Oncology, Hospital Trier, Trier.'}, {'ForeName': 'H-G', 'Initials': 'HG', 'LastName': 'Mergenthaler', 'Affiliation': 'Department of Oncology & Hematology, Klinikum Stuttgart, Stuttgart.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schubert', 'Affiliation': 'Department of Neurology, Hospital Minden, Minden.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Berdel', 'Affiliation': 'Department of Medicine A, University Hospital Muenster, Muenster.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Birkmann', 'Affiliation': 'Department of Hematology & Oncology, Hospital Nürnberg, Nürnberg.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hummel', 'Affiliation': 'Department of Pathology, Campus Benjamin Franklin, Charite Berlin, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thiel', 'Affiliation': 'Department of Hematology & Oncology, Campus Benjamin Franklin, Charite Berlin, Berlin, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fischer', 'Affiliation': 'Department of Hematology & Oncology, Campus Benjamin Franklin, Charite Berlin, Berlin, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr627']
1405,32423621,Clinical Outcomes of Stereotactic Body Radiotherapy With Immediate Versus Delayed Hormone Therapy in Men With Oligometastatic Recurrence of Prostate Cancer.,"AIMS


Stereotactic body radiotherapy (SBRT) with the delayed option of androgen deprivation therapy (ADT) is the current treatment paradigm in men relapsed with oligometastatic prostate cancer based on the outcome of a phase II randomised controlled study. The immediate (concomitant) use of ADT in this clinical setting potentially augments the efficacy of SBRT by improving systemic disease control. The aim of this study was to compare the clinical outcomes of these two treatment strategies.
MATERIALS AND METHODS


Eighty-eight patients with up to three oligometastases and controlled primary disease who had been treated using SBRT with immediate or delayed ADT were included in this retrospective analysis. Progression-free survival (PFS), widespread failure-free survival (WFFS) and freedom from further interventions (FFFI) were assessed using Kaplan-Meier and Cox proportional hazard regression methods. Toxicity was evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
RESULTS


Thirty-nine patients (44.3%) were treated with SBRT and immediate ADT (continuous ADT, n = 7; intermittent ADT, n = 32) and 49 (55.7%) with SBRT and delayed ADT. The median follow-up was 24 months (interquartile range 13.5-37.0 months). PFS in the immediate and delayed ADT groups were 26 months and 16 months, respectively (P < 0.007). The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025). The 1- and 2-year FFFI in the immediate ADT group were 88% and 64.1%, respectively, significantly higher than those in the delayed ADT group (63.8% and 30.2%, respectively, P < 0.002). Acute toxicities of grade 1-2 occurred in 17.9% of the immediate ADT group and 18.4% of the delayed ADT group (P = 0.96). Only one case of grade 3 late toxicity (pelvic insufficiency) was identified in this study.
CONCLUSIONS


SBRT with concomitant ADT improves PFS, WFFS and FFFI as compared with SBRT with delayed ADT; this finding needs validation in a prospective, randomised study.",2020,The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025).,"['men relapsed with oligometastatic prostate cancer', 'Men With Oligometastatic Recurrence of Prostate Cancer', 'Eighty-eight patients with up to three oligometastases and controlled primary disease who had been treated using SBRT with immediate or delayed ADT were included in this retrospective analysis']","['Stereotactic Body Radiotherapy With Immediate Versus Delayed Hormone Therapy', 'androgen deprivation therapy (ADT', 'SBRT and immediate ADT', 'SBRT with delayed ADT', 'SBRT with concomitant ADT', 'Stereotactic body radiotherapy (SBRT']","['PFS', 'grade 3 late toxicity (pelvic insufficiency', '1- and 2-year FFFI', 'Acute toxicities of grade 1-2', 'median WFFS', 'Toxicity', 'Progression-free survival (PFS), widespread failure-free survival (WFFS) and freedom from further interventions (FFFI', 'PFS, WFFS and FFFI']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",88.0,0.0423596,The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025).,"[{'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Chaw', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK. Electronic address: 0109061c@doctors.org.uk.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'deSouza', 'Affiliation': 'Cancer Research UK Imaging Centre, The Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Y E', 'Initials': 'YE', 'LastName': 'Suh', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van As', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.03.008']
1406,22383680,Influence of zoledronic acid on disseminated tumor cells in primary breast cancer patients.,"BACKGROUND


The presence of disseminated tumor cells (DTCs) in bone marrow of patients with early breast cancer (EBC) has been correlated with increased risk of metastatic disease or locoregional relapse. Zoledronic acid (ZOL) treatment has reduced DTCs in the bone marrow of patients with EBC in several studies. This controlled study sought to confirm these observations.
PATIENTS AND METHODS


Patients with EBC and DTC-positive bone marrow were randomized (N = 96) to treatment with ZOL plus adjuvant systemic therapy or adjuvant systemic therapy alone. The change in DTC numbers at 12 months versus baseline was measured.
RESULTS


DTC-positive patients treated with ZOL were more likely to become DTC-negative after 12 months of treatment compared with the controls (67% versus 35%; P = 0.009). At 12 months, DTC counts decreased to a mean of 0.5 ± 0.8 DTCs in the ZOL group and to 0.9 ± 0.8 DTCs in the control group. In addition, ZOL was generally well tolerated.
CONCLUSIONS


Treatment with ZOL improves elimination of DTCs. Further studies are needed to determine whether the reduction in DTCs by ZOL provides clinical benefit.",2012,"RESULTS


DTC-positive patients treated with ZOL were more likely to become DTC-negative after 12 months of treatment compared with the controls (67% versus 35%; P = 0.009).","['Patients with EBC and DTC-positive bone marrow were randomized (N = 96) to treatment with', 'patients with early breast cancer (EBC', 'primary breast cancer patients']","['ZOL plus adjuvant systemic therapy or adjuvant systemic therapy alone', 'Zoledronic acid (ZOL', 'ZOL', 'zoledronic acid']","['DTC counts', 'elimination of DTCs', 'tolerated', 'DTC numbers', 'DTC-negative']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.0398045,"RESULTS


DTC-positive patients treated with ZOL were more likely to become DTC-negative after 12 months of treatment compared with the controls (67% versus 35%; P = 0.009).","[{'ForeName': 'E-F', 'Initials': 'EF', 'LastName': 'Solomayer', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg. Electronic address: erich.solomayer@uks.eu.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gebauer', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Heidelberg, Heidelberg.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hirnle', 'Affiliation': 'Department of Radiation Oncology, Central Academic Hospital, Bielefeld.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, Heinrich-Heine University, Düsseldorf.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lück', 'Affiliation': 'Department of Gynecologic Oncology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Breast Center, Department of Senologie, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Krämer', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wackwitz', 'Affiliation': 'Norvartis Oncology, Department of Medical Affairs, Nuremberg.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wallwiener', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr612']
1407,31398997,Double-blind placebo-controlled randomized clinical trial of ginger ( Zingiber officinale Rosc. ) in the prophylactic treatment of migraine.,"BACKGROUND


Previous studies have shown an analgesic effect of ginger in the acute treatment of migraine, and there is anecdotal evidence of its efficacy in migraine prophylaxis.
OBJECTIVE


This study aimed to evaluate the potential of ginger to prevent migraine attacks.
METHODS


This double-blind, placebo-controlled randomized clinical trial took place at the Headache Clinic, Universidade Federal de Minas Gerais (Belo Horizonte, Minas Gerais, Brazil), involving 107 patients. Only subjects diagnosed with episodic migraine, aged between 18 and 60 years old, and who were not taking any prophylactic medication, were enrolled in the study. After one month of observation, subjects selected for the study were randomized 1:1 into placebo and treatment groups. Patients received capsules three times per day of 200 mg of dry extract of ginger (5% active ingredient) or placebo (cellulose) for three months. Visits were performed monthly and the patients were asked to fill in a migraine diary. The adherence to treatment was evaluated by counting capsules.
RESULTS


The percentage of patients who responded to treatment (i.e. a reduction of 50% in the number of migraine attacks at the end of treatment) did not differ between the groups. There was a decrease in the number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks in both groups, without significant difference between ginger and placebo groups.
CONCLUSIONS


Ginger provides no greater benefit in the prophylactic treatment of migraine when compared to placebo. This trial is registered at ClinicalTrials.gov (NCT02570633).",2020,"There was a decrease in the number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks in both groups, without significant difference between ginger and placebo groups.
","['Headache Clinic, Universidade Federal de Minas Gerais', '107 patients', 'Only subjects diagnosed with episodic migraine, aged between 18 and 60 years old, and who were not taking any prophylactic medication, were enrolled in the study']","['placebo', 'ginger ( Zingiber officinale Rosc. ', 'dry extract of ginger (5% active ingredient) or placebo (cellulose']","['number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks', 'number of migraine attacks']","[{'cui': 'C3839733', 'cui_str': 'Headache clinic (environment)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C1720167', 'cui_str': 'Dry extract (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]",107.0,0.513998,"There was a decrease in the number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks in both groups, without significant difference between ginger and placebo groups.
","[{'ForeName': 'Laís Bhering', 'Initials': 'LB', 'LastName': 'Martins', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Maria Dos Santos', 'Initials': 'AMDS', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Nayara Mussi', 'Initials': 'NM', 'LastName': 'Monteze', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Jenneffer Rayane Braga', 'Initials': 'JRB', 'LastName': 'Tibaes', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Matheus Henrique Alves', 'Initials': 'MHA', 'LastName': 'Amaral', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Rodrigo Santiago', 'Initials': 'RS', 'LastName': 'Gomez', 'Affiliation': 'University Hospital, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Santa Casa BH Ensino e Pesquisa, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adaliene Versiani Matos', 'Initials': 'AVM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419869319']
1408,31916717,The effects of enteral artificial amniotic fluid-containing erythropoietin on short term outcomes of preterm infants.,"Hosseini M, Azampour H, Raeisi S, Behtari M, Valizadeh H, Saboohi R. The effects of enteral artificial amniotic fluid-containing erythropoietin on short term outcomes of preterm infants. Turk J Pediatr 2019; 61: 392-398. Necrotizing Enterocolitis (NEC) is a common devastating gastrointestinal disease, which usually develops in premature infants. Erythropoietin (EPO) as a hematopoietic hormone produced by the kidney can also be naturally found in amniotic fluid and breast milk. There is some evidence that supports the contribution of EPO in the prevention of inflammation and intestinal tissue repair. This study was aimed to determine if oral administration of artificial amniotic fluid with or without EPO would protect preterm infants against NEC and improve the certain neonatal outcomes. In this study, 150 preterm infants with gestational age 28 weeks or less and birth weight 1250 grams or less were enrolled. The infants were divided randomly into 3 groups: 1) Control group (n=50) with routine feeding protocol without any administration; 2) Amniotic fluid group (n=50) with 5mL/kg synthetic amniotic fluid; 3) EPO group (n=50) with RhuEPO dissolved in the synthetic amniotic fluid. The administrations of the study solution were started 3 days after the birth and were continued for 3 weeks (21 days). The infants in the study groups were followed up until discharge and the frequency of NEC, mortality, and other complications of the disease among the groups were compared. The mortality rate in preterm infants of the amniotic fluid and EPO groups were significantly lower than in the control group (p=0.027). We couldn`t find any significant differences in the frequency of NEC and other complications among the three study groups. The administration of synthetic amniotic fluid (with or without EPO) in preterm infants may decrease the mortality rate. Use of EPO in synthetic amniotic fluid did not affect the frequency of NEC.",2019,The mortality rate in preterm infants of the amniotic fluid and EPO groups were significantly lower than in the control group (p=0.027).,"['150 preterm infants with gestational age 28 weeks or less and birth weight 1250 grams or less were enrolled', 'preterm infants', 'premature infants']","['Control group (n=50) with routine feeding protocol without any administration; 2) Amniotic fluid group (n=50) with 5mL/kg synthetic amniotic fluid; 3) EPO group (n=50) with RhuEPO dissolved in the synthetic amniotic fluid', 'synthetic amniotic fluid (with or without EPO', 'artificial amniotic fluid with or without EPO', 'Erythropoietin (EPO', 'enteral artificial amniotic fluid-containing erythropoietin', 'EPO']","['frequency of NEC', 'mortality rate', 'Necrotizing Enterocolitis (NEC', 'Hosseini M, Azampour H, Raeisi S, Behtari M, Valizadeh H, Saboohi R']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002638', 'cui_str': 'Amniotic Fluid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521688', 'cui_str': 'Dissolve (transformation)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}]",,0.0890697,The mortality rate in preterm infants of the amniotic fluid and EPO groups were significantly lower than in the control group (p=0.027).,"[{'ForeName': 'Mohammadbagher', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Azampour', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Raeisi', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Behtari', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Valizadeh', 'Affiliation': 'Department of Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Saboohi', 'Affiliation': 'Department of Neonatology, Al-Zahra Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",The Turkish journal of pediatrics,['10.24953/turkjped.2019.03.011']
1409,31927569,The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial.,"STUDY OBJECTIVES


While cognitive and behavioral therapy for insomnia (CBTi) is an effective treatment in patients with comorbid moderate and severe obstructive sleep apnea (OSA), there is concern that the bedtime restriction component of CBTi might dangerously exacerbate daytime sleepiness in such patients. We examined randomized controlled trial data to investigate the effect of OSA severity, and pretreatment daytime sleepiness on week-to-week changes in daytime sleepiness and sleep parameters during CBTi and no-treatment control.
METHODS


One hundred and forty-five patients with untreated physician-diagnosed OSA (apnea-hypopnea index ≥15) and psychologist-diagnosed insomnia (ICSD-3) were randomized to a 4-week CBTi program (n = 72) or no-treatment control (n = 73). The Epworth sleepiness scale (ESS) and sleep diaries were completed during pretreatment, weekly CBTi sessions, and posttreatment. Effects of OSA severity, pretreatment daytime sleepiness, and intervention group on weekly changes in daytime sleepiness and sleep parameters were investigated.
RESULTS


The CBTi group reported a 15% increase in ESS scores following the first week of bedtime restriction (M change = 1.3 points, 95% CI = 0.1-2.5, p = 0.031, Cohen's d = 0.27) which immediately returned to pretreatment levels for all subsequent weeks, while sleep parameters gradually improved throughout CBTi. There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups or OSA-severity groups. Higher pretreatment ESS scores were associated with a greater ESS reduction during CBTi.
CONCLUSIONS


CBTi appears to be a safe and effective treatment in the presence of comorbid moderate and severe OSA. Nevertheless, patients living with comorbid insomnia and sleep apnea and treated with CBTi should be monitored closely for increased daytime sleepiness during the initial weeks of bedtime restriction therapy.
CLINICAL TRIAL REGISTRATION


Treating comorbid insomnia with obstructive sleep apnoea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnoea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.",2020,"There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups, or OSA-severity groups.","['145 patients with untreated physician-diagnosed OSA (Apnea-hypopnea index≥15) and psychologist-diagnosed insomnia (ICSD-3', 'insomnia patients with co-morbid moderate and severe sleep apnea', 'patients with co-morbid moderate and severe obstructive sleep apnea (OSA']","['CBTi program', 'cognitive and behavioral therapy', 'CBTi']","['sleepiness and sleep parameters', 'Epworth sleepiness scale (ESS) and sleep diaries', 'daytime sleepiness', 'daytime sleepiness and sleep parameters', 'OSA-severity, pre-treatment daytime sleepiness', 'OSA severity, and pre-treatment daytime sleepiness', 'ESS scores']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",145.0,0.0147282,"There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups, or OSA-severity groups.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sweetman', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Science Research (ISSR), University of Queensland, Indooroopilly, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Grady"", 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunn', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'College of Education Psychology and Social Work, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}]",Sleep,['10.1093/sleep/zsaa002']
1410,31395122,Off-Pump Versus On-Pump Bypass Surgery for Left Main Coronary Artery Disease.,"BACKGROUND


Concerns remain for a greater risk of incomplete revascularization and reduced survival with off-pump coronary artery bypass grafting (CABG) surgery compared with on-pump surgery particularly in patients with left main disease and extensive underlying myocardial ischemia.
OBJECTIVES


This study sought to compare outcomes following off-pump versus on-pump surgery for left main disease by performing a post hoc analysis from the multicenter, randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial.
METHODS


The EXCEL trial was designed to compare percutaneous coronary intervention with everolimus-eluting stents versus CABG in patients with left main disease. CABG was performed with or without cardiopulmonary bypass (on-pump vs. off-pump surgery) according to the discretion of the operator. The 3-year outcomes in the off-pump and on-pump groups were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation.
RESULTS


Among 923 CABG patients, 652 and 271 patients underwent on-pump and off-pump surgery, respectively. Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007). After IPTW adjustment for baseline differences, off-pump surgery was associated with a significantly increased risk of 3-year all-cause death (8.8% vs. 4.5%; hazard ratio: 1.94; 95% confidence interval: 1.10 to 3.41; p = 0.02) and a nonsignificant difference in the risk for the composite endpoint of death, myocardial infarction, or stroke (11.8% vs. 9.2%; hazard ratio: 1.28; 95% confidence interval: 0.82 to 2.00; p = 0.28).
CONCLUSIONS


Among patients with left main disease treated with CABG in the EXCEL trial, off-pump surgery was associated with a lower rate of revascularization of the coronary arteries supplying the inferolateral wall and an increased risk of 3-year all-cause death compared with on-pump surgery.",2019,"Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007).","['patients with left main disease and extensive underlying myocardial ischemia', '923 CABG patients, 652 and 271 patients underwent on-pump and off-pump surgery, respectively', 'patients with left main disease treated with', 'patients with left main disease']","['everolimus-eluting stents versus CABG', 'Off-Pump Versus On-Pump Bypass Surgery', 'pump coronary artery bypass grafting (CABG) surgery', 'CABG', 'pump versus on-pump surgery', 'XIENCE versus Coronary Artery Bypass Surgery']","['rate of revascularization of the left circumflex coronary artery', 'rate of revascularization of the coronary arteries supplying the inferolateral wall and an increased risk of 3-year all-cause death', '3-year outcomes', 'risk of 3-year all-cause death', 'death, myocardial infarction, or stroke', 'right coronary artery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}]",923.0,0.311361,"Despite a similar extent of disease, off-pump surgery was associated with a lower rate of revascularization of the left circumflex coronary artery (84.1% vs. 90.0%; p = 0.01) and right coronary artery (31.1% vs. 40.6%; p = 0.007).","[{'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'University of Bristol, Bristol, United Kingdom. Electronic address: umberto.benedetto@bristol.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Saint Luke's Hospital, New York, New York.""}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'W Morris', 'Initials': 'WM', 'LastName': 'Brown', 'Affiliation': 'Piedmont Atlanta Hospital, Atlanta, Georgia.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Horkay', 'Affiliation': 'National Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Piet W', 'Initials': 'PW', 'LastName': 'Boonstra', 'Affiliation': 'Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Bogáts', 'Affiliation': 'University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': 'Hôpital Hôtel-Dieu de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center, New York, New York. Electronic address: https://twitter.com/GreggWStone.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.05.063']
1411,31693129,Phase III Randomized Trial of Bisphosphonates as Adjuvant Therapy in Breast Cancer: S0307.,"BACKGROUND


Adjuvant bisphosphonates, when given in a low-estrogen environment, can decrease breast cancer recurrence and death. Treatment guidelines include recommendations for adjuvant bisphosphonates in postmenopausal patients. SWOG/Alliance/Canadian Cancer Trials Group/ECOG-ACRIN/NRG Oncology study S0307 compared the efficacy of three bisphosphonates in early-stage breast cancer.
METHODS


Patients with stage I-III breast cancer were randomly assigned to 3 years of intravenous zoledronic acid, oral clodronate, or oral ibandronate. The primary endpoint was disease-free survival (DFS) with overall survival as a secondary outcome. All statistical tests were two-sided.
RESULTS


A total of 6097 patients enrolled. Median age was 52.7 years. Prior to being randomly assigned, 73.2% patients indicated preference for oral vs intravenous formulation. DFS did not differ across arms in a log-rank test (P = .49); 5-year DFS was 88.3% (zoledronic acid: 95% confidence interval [CI] = 86.9% to 89.6%), 87.6% (clodronate: 95% CI = 86.1% to 88.9%), and 87.4% (ibandronate: 95% CI = 85.6% to 88.9%). Additionally, 5-year overall survival did not differ between arms (log rank P = .50) and was 92.6% (zoledronic acid: 95% CI = 91.4% to 93.6%), 92.4% (clodronate: 95% CI = 91.2% to 93.5%), and 92.9% (ibandronate: 95% CI = 91.5% to 94.1%). Bone as first site of recurrence did not differ between arms (P = .93). Analyses based on age and tumor subtypes showed no treatment differences. Grade 3/4 toxicity was 8.8% (zoledronic acid), 8.3% (clodronate), and 10.5% (ibandronate). Osteonecrosis of the jaw was highest for zoledronic acid (1.26%) compared with clodronate (0.36%) and ibandronate (0.77%).
CONCLUSIONS


We found no evidence of differences in efficacy by type of bisphosphonate, either in overall analysis or subgroups. Despite an increased rate of osteonecrosis of the jaw with zoledronic acid, overall toxicity grade differed little across arms. Given that patients expressed preference for oral formulation, efforts to make oral agents available in the United States should be considered.",2020,"Osteonecrosis of the Jaw (ONJ) was highest for zoledronic acid (1.26%), compared to clodronate (0.36%) and ibandronate (0.77%).
","['Patients with stage I-III breast cancer', '6,097 patients enrolled', 'breast cancer', 'Median age was 52.7 years', 'early stage breast cancer', 'postmenopausal patients']","['clodronate', 'bisphosphonate', 'zoledronic acid', 'intravenous zoledronic acid, oral clodronate, or oral ibandronate', 'bisphosphonates']","['Osteonecrosis of the Jaw (ONJ', 'breast cancer recurrence and death', 'Grade 3/4 toxicity', 'disease-free survival (DFS) with overall survival (OS', 'DFS', '5-year', 'rate of ONJ with zoledronic acid, overall toxicity grade']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}]","[{'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]",,0.212636,"Osteonecrosis of the Jaw (ONJ) was highest for zoledronic acid (1.26%), compared to clodronate (0.36%) and ibandronate (0.77%).
","[{'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Alexander H G', 'Initials': 'AHG', 'LastName': 'Paterson', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jieling L', 'Initials': 'JL', 'LastName': ""M'iao"", 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Danika L', 'Initials': 'DL', 'LastName': 'Lew', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Alison T', 'Initials': 'AT', 'LastName': 'Stopeck', 'Affiliation': 'Stony Brook Cancer Center, Stony Brook University Cancer Center, Stony Brook, NY.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan, Ann Arbor, MI (DFH, CHVP); Columbia University, New York, NY.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': ''}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Schubert', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Van Poznak', 'Affiliation': ''}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Carla I', 'Initials': 'CI', 'LastName': 'Falkson', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Elias', 'Affiliation': 'University of Colorado, Denver, CO.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Messino', 'Affiliation': 'Cancer Care of WNC, Greenville, NC.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Margolis', 'Affiliation': 'Beaumont NCORP/William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Chew', 'Affiliation': 'University of California at Davis, Sacramento, CA.'}, {'ForeName': 'Kim Z', 'Initials': 'KZ', 'LastName': 'Dammann', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Abrams', 'Affiliation': 'Cancer Therapy and Evaluation Program, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Livingston', 'Affiliation': 'University of Arizona, Tucson, AZ.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz215']
1412,21913385,[Repression of bacterial biofilms in suppurative necrotic complications of diabetic foot syndrome by ultrasound cavitation].,"AIM


Study of wound microbial landscape in suppurative necrotic complications in patients with diabetic foot syndrome (DFS), and a possibility of suppression of bacterial biofilm development in these wounds by ultrasound cavitation (USC).
MATERIALS AND METHODS


2 randomized groups of patients were included in the study: main group of 145 individuals with suppurative necrotic complications of DFS, who received ultrasound cavitation therapy, and comparison group of 86 patients who received basic therapy. In the main group Sonoca-180 (Siring, Germany) unit, that allows to combine the process of mechanical wound treatment with antibacterial action of low frequency ultrasound, was used for wound treatment. Quantitative and qualitative composition of wound microflora was studied by using bacteriological method with parallel utilization of transmission and scanning electron microscopy in the dynamic of USC treatment.
RESULTS


In patients with DFS bacterial biofilms containing congestions in the polysaccharide matrix and fixed at the surface of dense structure of periostenum wound were detected. In the microbial landscape in DFS patients in 21% of cases aerobic-anaerobic microflora was detected, while associations included mostly from 2 to 5 bacteria species--members of the Peptococcus, Peptostreptococcus, Prevotella, Bacteroides genera. Bacteria of Staphylococcus, Acinetobacter, Pseudomonas, Escherichia and Klebsiella sp. genera were detected less frequently. Application of USC in the main group resulted in a decrease of microbial contamination of wounds in the short-term.
CONCLUSION


USC method, when compared with classical therapy approach in DFS complications, in patients with suppurative necrotic complications allows not only to remove mechanically the necrotic tissues but also to effectively suppress the bacterial biofilms that have formed in the wounds, this promotes the acceleration of recovery process and preparation of the patients for further plastic surgery intervention.",2011,"Application of USC in the main group resulted in a decrease of microbial contamination of wounds in the short-term.
","['patients with suppurative necrotic complications', 'patients with diabetic foot syndrome (DFS', '2 randomized groups of patients were included in the study: main group of 145 individuals with suppurative necrotic complications of DFS, who received ultrasound cavitation therapy, and comparison group of 86 patients who received']","['classical therapy approach', 'wound microbial landscape', 'basic therapy', 'ultrasound cavitation', 'USC']","['suppurative necrotic complications', 'microbial contamination of wounds']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3249881', 'cui_str': 'Infection - suppurative (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}]","[{'cui': 'C3249881', 'cui_str': 'Infection - suppurative (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",145.0,0.0223897,"Application of USC in the main group resulted in a decrease of microbial contamination of wounds in the short-term.
","[{'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Risman', 'Affiliation': ''}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': ""Rybal'chenko"", 'Affiliation': ''}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Bondarenko', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Ryzhankova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1413,21916043,[Evaluation of immunogenicity and safety of 2 immunizations with allantoic intranasal live influenza vaccine Ultragrivac].,"AIM


Evaluate reactogenicity, safety and immunogenicity in phase 2 clinical trials of 2 immunization schedules with Ultragrivac--an allantoic intranasal life influenza vaccine based on A/17/ duck/Potsdam/86/92 [17/H5] reassortant strain.
MATERIALS AND METHODS


4 groups of volunteers participated in the study: group 1--40 individuals were vaccinated twice with a 10 day interval; group 2--40 individuals were vaccinated twice with a 21 day interval; group 3 (control)--10 individuals received placebo twice with a 10 day interval; group 4 (control)--10 individuals received placebo twice with a 21 day interval. Local (secretory IgA), cellular and humoral immune response were evaluated. Humoral immunity was evaluated by the intensity of increase of geometric mean antibody titers against 2 influenza virus strains A/17/duck/Potsdam/86/92 [17/H5] and A/chicken/Suzdalka/Nov-1 1/2005 (H5N1), and by the level of significant (4 times or more) antibody seroconversions after the vaccination.
RESULTS


After the use of Ultragrivac the level of secretory IgA in the nasal cavity of vaccinated volunteers in the groups with revaccination intervals of 10 and 21 days increased significantly. The second immunization with 10 or 21 day intervals significantly increased postvaccinal humoral immune response. Humoral immune response induction after 2 vaccinations with 10 day interval was no less effective than with 21 day interval.
CONCLUSION


Ultragrivac allantoic intranasal live influenza vaccine is areactogenic, harmless for vaccinated individuals, safe for those around, and has immunogenic properties against not only homologous virus A(H5N2), but also against influenza strain A(H5N1).",2011,"Humoral immunity was evaluated by the intensity of increase of geometric mean antibody titers against 2 influenza virus strains A/17/duck/Potsdam/86/92 [17/H5] and A/chicken/Suzdalka/Nov-1 1/2005 (H5N1), and by the level of significant (4 times or more) antibody seroconversions after the vaccination.
",['4 groups of volunteers participated in the study: group 1--40 individuals were'],"['Ultragrivac--an allantoic intranasal life influenza vaccine', 'allantoic intranasal live influenza vaccine Ultragrivac', 'vaccinated twice with a 10 day interval; group 2--40 individuals were vaccinated twice with a 21 day interval; group 3 (control)--10 individuals received placebo twice with a 10 day interval; group 4 (control)--10 individuals received placebo']","['geometric mean antibody titers', 'Humoral immune response induction', 'reactogenicity, safety and immunogenicity', 'postvaccinal humoral immune response', 'Local (secretory IgA), cellular and humoral immune response', 'Humoral immunity']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3253832', 'cui_str': 'Ultragrivac'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C1155229'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0020838', 'cui_str': 'Secretory IgA'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}]",,0.054815,"Humoral immunity was evaluated by the intensity of increase of geometric mean antibody titers against 2 influenza virus strains A/17/duck/Potsdam/86/92 [17/H5] and A/chicken/Suzdalka/Nov-1 1/2005 (H5N1), and by the level of significant (4 times or more) antibody seroconversions after the vaccination.
","[{'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Shishkina', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Mazurkova', 'Affiliation': ''}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Ternovoĭ', 'Affiliation': ''}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Bulychev', 'Affiliation': ''}, {'ForeName': 'Iu V', 'Initials': 'IuV', 'LastName': 'Tumanov', 'Affiliation': ''}, {'ForeName': 'M O', 'Initials': 'MO', 'LastName': 'Skarnovich', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Kabanov', 'Affiliation': ''}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Ryndiuk', 'Affiliation': ''}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Kuzubov', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Mironov', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stavskiĭ', 'Affiliation': ''}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Drozdov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1414,31941381,Homocysteine Level Predicts Response to Dual Antiplatelet in Women With Minor Stroke or Transient Ischemic Attack: Subanalysis of the CHANCE Trial.,"OBJECTIVES


To investigate the relationship of homocysteine levels with the efficacy and safety of dual antiplatelet therapy in female and male patients. Approach and Results: The CHANCE trial (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events) randomized patients with acute minor ischemic stroke or high-risk transient ischemic attack to clopidogrel plus aspirin or aspirin alone from October 1, 2009, to July 30, 2012, in China. A subgroup of 3044 consecutive patients with baseline homocysteine levels from 73 (64%) prespecified clinical sites was analyzed. Participants were grouped by sex. Primary outcome was stroke recurrence within 90 days. Secondary outcomes consisted of composite vascular events and independent living or death. Safety outcome was any bleeding. Cox proportional-hazards models were used to assess the interaction of homocysteine levels with randomized antiplatelet therapy on efficacy and safety outcomes. A significant interaction between homocysteine levels and the randomized antiplatelet therapies was found on recurrent stroke after adjustment for confounding factors in women ( P =0.010) but not in men ( P =0.595). Compared with aspirin alone, clopidogrel plus aspirin significantly reduced the risk of recurrent stroke in women without elevated homocysteine levels (adjusted hazard ratio, 0.459 [95% CI, 0.271-0.776];  P =0.004). Such benefit disappeared in female patients with increased homocysteine level. No significant interaction on functional outcome or bleeding rate was observed.
CONCLUSIONS


Homocysteine could be a potential biomarker to discriminate the effects of dual and single antiplatelet therapy in female patients with minor ischemic stroke or high-risk transient ischemic attack.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT00979589.",2020,A significant interaction between homocysteine levels and the randomized antiplatelet therapies was found on recurrent stroke after adjustment for confounding factors in women ( P =0.010) but not in men ( P =0.595).,"['female patients with increased homocysteine level', 'Women With Minor Stroke or Transient Ischemic Attack', '3044 consecutive patients with baseline homocysteine levels from 73 (64%) prespecified clinical sites was analyzed', 'alone from October 1, 2009, to July 30, 2012, in China', 'female and male patients', 'High-Risk Patients With Acute Nondisabling Cerebrovascular Events) randomized patients with acute minor ischemic stroke or high-risk transient ischemic attack to', 'female patients with minor ischemic stroke or high-risk transient ischemic attack']","['clopidogrel plus aspirin', 'aspirin', 'clopidogrel plus aspirin or aspirin', 'dual antiplatelet therapy']","['stroke recurrence', 'functional outcome or bleeding rate', 'efficacy and safety outcomes', 'recurrent stroke', 'homocysteine levels', 'bleeding', 'composite vascular events and independent living or death', 'risk of recurrent stroke']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",3044.0,0.246809,A significant interaction between homocysteine levels and the randomized antiplatelet therapies was found on recurrent stroke after adjustment for confounding factors in women ( P =0.010) but not in men ( P =0.595).,"[{'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zuo', 'Affiliation': 'Department of Anesthesiology, University of Virginia Health System, Charlottesville (Z.Z.).'}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Anxin', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.119.313741']
1415,31305878,Association of Screen Time and Depression in Adolescence.,"Importance


Increases in screen time have been found to be associated with increases in depressive symptoms. However, longitudinal studies are lacking.
Objective


To repeatedly measure the association between screen time and depression to test 3 explanatory hypotheses: displacement, upward social comparison, and reinforcing spirals.
Design, Setting, and Participants


This secondary analysis used data from a randomized clinical trial assessing the 4-year efficacy of a personality-targeted drug and alcohol prevention intervention. This study assessed screen time and depression throughout 4 years, using an annual survey in a sample of adolescents who entered the seventh grade in 31 schools in the Greater Montreal area. Data were collected from September 2012 to September 2018. Analysis began and ended in December 2018.
Main Outcomes and Measures


Independent variables were social media, television, video gaming, and computer use. Symptoms of depression was the outcome, measured using the Brief Symptoms Inventory. Exercise and self-esteem were assessed to test displacement and upward social comparison hypothesis.
Results


A total of 3826 adolescents (1798 girls [47%]; mean [SD] age, 12.7 [0.5] years) were included. In general, depression symptoms increased yearly (year 1 mean [SD], 4.29 [5.10] points; year 4 mean [SD], 5.45 [5.93] points). Multilevel models, which included random intercepts at the school and individual level estimated between-person and within-person associations between screen time and depression. Significant between-person associations showed that for every increased hour spent using social media, adolescents showed a 0.64-unit increase in depressive symptoms (95% CI, 0.32-0.51). Similar between-level associations were reported for computer use (0.69; 95% CI, 0.47-0.91). Significant within-person associations revealed that a further 1-hour increase in social media use in a given year was associated with a further 0.41-unit increase in depressive symptoms in that same year. A similar within-person association was found for television (0.18; 95% CI, 0.09-0.27). Significant between-person and within-person associations between screen time and exercise and self-esteem supported upward social comparison and not displacement hypothesis. Furthermore, a significant interaction between the between-person and within-person associations concerning social media and self-esteem supported reinforcing spirals hypothesis.
Conclusions and Relevance


Time-varying associations between social media, television, and depression were found, which appeared to be more explained by upward social comparison and reinforcing spirals hypotheses than by the displacement hypothesis. Both screen time modes should be taken into account when developing preventive measures and when advising parents.",2019,Significant between-person and within-person associations between screen time and exercise and self-esteem supported upward social comparison and not displacement hypothesis.,"['adolescents who entered the seventh grade in 31 schools in the Greater Montreal area', '3826 adolescents (1798 girls [47%]; mean [SD] age, 12.7 [0.5] years) were included']",['personality-targeted drug and alcohol prevention intervention'],"['Exercise and self-esteem', 'depressive symptoms', 'social media use', 'social media, television, video gaming, and computer use']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]",3826.0,0.0313868,Significant between-person and within-person associations between screen time and exercise and self-esteem supported upward social comparison and not displacement hypothesis.,"[{'ForeName': 'Elroy', 'Initials': 'E', 'LastName': 'Boers', 'Affiliation': 'Department of Psychiatry, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Afzali', 'Affiliation': 'Department of Psychiatry, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Newton', 'Affiliation': 'University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Conrod', 'Affiliation': 'Department of Psychiatry, University of Montreal, Montreal, Quebec, Canada.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.1759']
1416,31697042,Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.,"INTRODUCTION


Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers.
METHODS


A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/V urea   ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data.
FINDINGS


Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/V urea  was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home.
CONCLUSION


Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.",2020,The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods.,"['Thirty participants enrolled and 28 completed all trial periods', 'patients and/or caregivers']",['Tablo hemodialysis system'],"['weekly standard Kt/V urea  \u2009≥\u20092.1', 'intention-to-treat cohort', 'delivery of ultrafiltration (UF', 'median resolution time of alarms', 'Safety and efficacy', 'adverse events (AEs', 'secondary efficacy UF endpoint', 'safety and efficacy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",30.0,0.0341899,The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods.,"[{'ForeName': 'Troy J', 'Initials': 'TJ', 'LastName': 'Plumb', 'Affiliation': 'University of Nebraska, Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Alvarez', 'Affiliation': 'Palo Alto Medical Foundation, Palo Alto, California, USA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Ross', 'Affiliation': 'Kansas Nephrology Research Institute, Wichita, Kansas, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Nephrology Associates Medical Group, Riverside, California, USA.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Mulhern', 'Affiliation': 'Fresenius Kidney Care Pioneer Valley Dialysis, West Springfield, Massachusetts, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': 'Southwest Georgia Nephrology Clinic, Albany, Georgia, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Abra', 'Affiliation': 'Satellite Healthcare, Mountain View, California, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Prichard', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Aragon', 'Affiliation': 'Clinical Development, Outset Medical, San Jose, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12795']
1417,32046656,Stratified primary care versus non-stratified care for musculoskeletal pain: qualitative findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.,"BACKGROUND


Stratified care involves subgrouping patients based on key characteristics, e.g. prognostic risk, and matching these subgroups to appropriate early treatment options. The STarT MSK feasibility and pilot cluster randomised controlled trial (RCT) examined the feasibility of a future main trial and of delivering prognostic stratified primary care for patients with musculoskeletal pain. The pilot RCT was conducted in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK development tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. This paper reports on a nested qualitative study exploring the feasibility of delivering stratified care ahead of the main trial.
METHODS


'Stimulated-recall' interviews were conducted with patients and GPs in the stratified care arm (n = 10 patients; 10 GPs), prompted by consultation recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Capability, Opportunity and Motivation GPs and patients had to engage with stratified care.
RESULTS


Patients reported positive views that stratified care enabled a more 'structured' consultation, and felt tool items were useful in making GPs aware of patients' worries and concerns. However, the closed nature of the tool's items was seen as a barrier to opening up discussion. GPs identified difficulties integrating the tool within consultations (Opportunity), but found this easier as it became more familiar. Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability). Most GPs reported that the matched treatment options aided their clinical decision-making (Motivation), but identified some options that were not available to them (e.g. pain management clinics), and other options that were not included in the matched treatments but which were felt appropriate for some patients (e.g. consider imaging).
CONCLUSION


This nested qualitative study, using the COM-B model, identified amendments required for the main trial including changes to the Keele STarT MSK tool and matched treatment options, targeting the COM-B model constructs, and these have been implemented in the current main trial.
TRIAL REGISTRATION


ISRCTN 15366334.",2020,"Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability).","[""Stimulated-recall' interviews were conducted with patients and GPs in the stratified care arm (n\xa0=\u200910 patients; 10 GPs"", 'patients with musculoskeletal pain', '8 UK general practices (4 stratified care; 4 usual care) with 524 patients']",['Stratified primary care versus non-stratified care'],[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],,0.0699847,"Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK. b.saunders@keele.ac.uk.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Cooper', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Protheroe', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chudyk', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chew-Graham', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Bartlam', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}]",BMC family practice,['10.1186/s12875-020-1098-1']
1418,32046647,Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.,"BACKGROUND


Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations.
METHODS


The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making.
RESULTS


GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved ""complete success"".
CONCLUSIONS


A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments.
TRIAL REGISTRATION


Name of the registry: ISRCTN.
TRIAL REGISTRATION NUMBER


15366334. Date of registration: 06/04/2016.",2020,"GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved ""complete success"".
","['Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template', '3063 patients (intervention\u2009=\u20091591, control\u2009=\u20091472), completed the EMR template with 1237 eligible patients (intervention\u2009=\u2009513, control\u2009=\u2009724) and 524 participants (42%) consented to data collection (intervention\u2009=\u2009231, control\u2009=\u2009293', 'patients with low back pain', 'Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities']",['Stratified primary care versus non-stratified care'],"['exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity']","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036577', 'cui_str': 'Selection Bias'}]",,0.142764,"GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved ""complete success"".
","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK. j.hill@keele.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Garvin', 'Affiliation': 'Keele Clinical Trials Unit, School for Primary, Community and Social Care, Faculty of Medicine and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cooper', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wathall', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Protheroe', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chudyk', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Dunn', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van der Windt', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}]",BMC family practice,['10.1186/s12875-019-1074-9']
1419,31751776,"Adapting home telehealth group appointment model (CoYoT1 clinic) for a low SES, publicly insured, minority young adult population with type 1 diabetes.","As more individuals from diverse backgrounds are diagnosed with Type 1 Diabetes (T1D), the need to address resulting disparities in diabetes outcomes among these populations also escalates. Although young adulthood proves challenging for all patients with diabetes, young adults (YA) from racial/ethnic minorities and low socioeconomic backgrounds face even greater T1D management obstacles. The poorer outcomes in these populations drive an urgent need for alternative care models to improve YA's engagement in their T1D clinical care and address barriers to improved health outcomes. Previous telemedicine initiatives for T1D have yielded positive diabetes care results, especially in YA, offering one promising way to reach this high-risk population. To serve these patients better, an established and successful home telehealth group appointment model, ""CoYoT1 Clinic"" (Colorado Young Adults with T1D), was adapted to provide care to YA with T1D at a large urban children's hospital in Southern California. At this location, ~70% of patients have public/no insurance, and 85% are racial/ethnic minorities. In this paper, we report the process of adapting the CoYoT1 Clinic model and designing a randomized controlled trial (RCT) to evaluate its efficacy. The adapted model uses meticulous study-design methods that incorporate patient advisors, quantitative and qualitative data collection, collaboration with local stakeholders, intervention development, and patient randomization into a factorial design analyzing telemedicine versus in-person and patient-centered versus standard care. The new model addresses the needs of high-risk YA in Southern California, with the goal of increasing access to care, improving follow-up frequency, and strengthening patient and provider satisfaction. The study is registered with ClinicalTrials.gov (Clinical Trials Number: NCT03793673).",2020,The poorer outcomes in these populations drive an urgent need for alternative care models to improve YA's engagement in their T1D clinical care and address barriers to improved health outcomes.,"[""Colorado Young Adults with T1D), was adapted to provide care to YA with T1D at a large urban children's hospital in Southern California"", 'minority young adult population with type 1 diabetes']",['CoYoT1 Clinic'],[],"[{'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",[],,0.0516039,The poorer outcomes in these populations drive an urgent need for alternative care models to improve YA's engagement in their T1D clinical care and address barriers to improved health outcomes.,"[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Children's Hospital Los Angeles, USA; Keck School of Medicine of the University of Southern California, USA. Electronic address: jraymond@chla.usc.edu.""}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Reid', 'Affiliation': ""Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fox', 'Affiliation': 'University of Southern California School of Pharmacy, Department of Pharmaceutical and Health Economics, USA; USC Schaeffer Center for Health Economics and Policy, USA.'}, {'ForeName': 'Jaquelin Flores', 'Initials': 'JF', 'LastName': 'Garcia', 'Affiliation': ""Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': ""Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bisno', 'Affiliation': ""Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Fogel', 'Affiliation': ""Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Subramanian', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': ""Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Pyatak', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105896']
1420,32067100,Two-year outcome data suggest that less invasive surfactant administration (LISA) is safe. Results from the follow-up of the randomized controlled AMV (avoid mechanical ventilation) study.,"Less invasive surfactant administration (LISA) is a method to deliver surfactant to spontaneously breathing premature infants via a thin catheter. Here we report the two-year outcome from the AMV (avoid mechanical ventilation) study, the first randomized controlled trial on this mode of surfactant delivery. No statistically significant differences in weight, length or neurodevelopmental outcome (Bayley II scores) were found between the LISA intervention group (n = 95) and the control group (n = 84) that received standard treatment.Conclusion: No differences in outcome were observed at 2 years. LISA seems safe in that aspect. What is Known: • LISA is a method that is in increasing use for surfactant delivery to spontaneously breathing infants. LISA reduces the need for mechanical ventilation. What is New: • Outcome data at 2 years from the first randomized study with LISA raise no safety concerns in comparison to a group of infants that received standard treatment.",2020,"No statistically significant differences in weight, length or neurodevelopmental outcome (Bayley II scores) were found between the LISA intervention group (n = 95) and the control group (n = 84) that received standard treatment.",['spontaneously breathing infants'],"['LISA intervention', 'LISA', 'invasive surfactant administration (LISA']","['weight, length or neurodevelopmental outcome (Bayley II scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0760559,"No statistically significant differences in weight, length or neurodevelopmental outcome (Bayley II scores) were found between the LISA intervention group (n = 95) and the control group (n = 84) that received standard treatment.","[{'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Paediatrics, University Hospital of Schleswig-Holstein, University of Lübeck, Ratzeburger Allee 160, D-23538, Lübeck, Germany. egbert.herting@uksh.de.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': 'Department of Neonatology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Härtel', 'Affiliation': 'Department of Paediatrics, University Hospital of Schleswig-Holstein, University of Lübeck, Ratzeburger Allee 160, D-23538, Lübeck, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'von der Wense', 'Affiliation': ""Department of Neonatology, Children's Hospital Hamburg-Altona, Hamburg, Germany.""}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Weller', 'Affiliation': 'Department of Paediatrics, Evangelical Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hoehn', 'Affiliation': 'Department of Paediatrics, University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vochem', 'Affiliation': 'Department of Neonatology, Olgahospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Möller', 'Affiliation': 'Department of Paediatrics, Saarbrücken General Hospital, Saarbrücken, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wieg', 'Affiliation': ""Germany Children's Hospital Aschaffenburg-Alzenau, Aschaffenburg, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Department of Neonatology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Paediatrics, University Hospital of Schleswig-Holstein, University of Lübeck, Ratzeburger Allee 160, D-23538, Lübeck, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of pediatrics,['10.1007/s00431-020-03572-0']
1421,31539025,Preoperative VolumE Replacement therapy in DIabetic patients undergoing coronary artery bypass grafting surgery: results from an open parallel group randomized Controlled Trial (VeRDiCT).,"OBJECTIVES


To investigate the effect of preoperative volume replacement therapy (VRT) on renal function, health outcome and time to fitness for discharge in diabetic patients undergoing coronary artery bypass grafting (CABG).
METHODS


In 2 parallel randomized controlled trials, diabetic patients were allocated to preoperative VRT (1 ml/kg/h of Hartmann's solution for 12 h) or usual care. Primary outcome was time to fitness for discharge. Secondary outcomes included acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury.
RESULTS


In total, 169 patients were randomized (84 VRT, 85 usual care; mean age 64 years; 88% male). Time to fitness for discharge was similar between groups [median 6 days; interquartile range 5.0-9.0 in both groups; hazard ratio 0.95, 95% confidence interval (CI) 0.65-1.38; P = 0.78]. Postoperative acute kidney injury was not statistically different (VRT: 27.7% vs usual care: 18.8%, odds ratio 1.72, 95% CI 0.82-3.59; P = 0.15). Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR) 1.16, 95% CI 0.94-1.42; P = 0.16], N-acetyl-beta-d-glucosaminidase (GMR 1.08, 95% CI 0.83-1.40; P = 0.57), C-reactive protein (GMR 1.00, 95% CI 0.88-1.13; P = 0.94), troponin T (Trop-T; GMR 1.18, 95% CI 0.78-1.79; P = 0.39) and other secondary health outcomes were similar between groups. QoL improved in both groups at 3 months with no difference observed.
CONCLUSIONS


The use of preoperative VRT is not superior to usual care in diabetic patients undergoing CABG.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN02159606.",2020,"Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR)","['diabetic patients', '169 patients were randomized (84 VRT, 85 usual care; mean age 64\u2009years; 88% male', 'diabetic patients undergoing coronary artery bypass grafting (CABG', 'DIabetic patients undergoing coronary artery bypass grafting surgery', 'diabetic patients undergoing CABG']","['preoperative VRT', 'Preoperative VolumE Replacement therapy', ""preoperative VRT (1\u2009ml/kg/h of Hartmann's solution for 12\u2009h) or usual care"", 'preoperative volume replacement therapy (VRT']","['Postoperative acute kidney injury', 'Time to fitness for discharge', 'time to fitness for discharge', 'acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury', 'renal function, health outcome and time to fitness for discharge', 'secondary health outcomes', 'microalbumin/creatinine ratio [geometric mean ratio (GMR', 'C-reactive protein', 'QoL', 'Estimated glomerular filtration rate']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3811844'}]",169.0,0.370451,"Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR)","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'Rosie A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Wells', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'Barney', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hillier', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Ascione', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivz226']
1422,31535360,An Overnight Stay Versus three Days Admission after Uncomplicated Percutaneous Nephrolithotomy: A Randomized Clinical Trial.,"PURPOSE


To evaluate the safety and efficacy of discharging patients on the first postoperative day after an uncomplicated percutaneous nephrolithotomy (PCNL).
MATERIALS AND METHODS


after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day, we randomly assigned patients into two groups-Group 1: overnight surgery, and Group 2: routine discharge after three days. Patients with significant residual stone on control fluoroscopy were excluded. Ninety eight and 102 patients were assigned to groups 1 and 2, respectively. Serum Hemoglobin and Cr were evaluated before the operation as well as the first postoperative day. Stone free status was evaluated using ultrasound and KUB radiography at the first postoperative day.
RESULTS


The stone and patient characteristics were not different in two groups. The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups. Nine patients (9.2%) in Group 1 and five (4.9%) in Group 2 were readmitted because of complications (mainly hematuria) (p=.23). Of the readmitted patients, five in Group 1 (55%), and three in Group 2 (60%) received blood transfusion (p=.87). in these patients, group 1 received 1.6±0.51 units of blood compared with 1.93±0.25 in group 2 (p=.07). All the readmitted patients did well with conservative therapy with no need for angioembolization.
CONCLUSION


In uncomplicated PCNL with no significant residual stone, discharging the patient on the first postoperative day is safe. The outcome is comparable to a routine three-day hospital stay.",2020,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"['after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day', 'Patients with significant residual stone on control fluoroscopy were excluded', 'Ninety eight and 102 patients']","['overnight surgery, and Group 2: routine discharge', 'Overnight Stay Versus three Days Admission after uncomplicated Percutaneous Nephrolithotomy', 'uncomplicated percutaneous nephrolithotomy (PCNL']","['Serum Hemoglobin and Cr', 'blood transfusion', 'hemoglobin and creatinine levels', 'safety and efficacy']","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0356594,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Basiri@unrc.ir.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Department of Surgery, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran. drdavoodarab@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Pakmanesh', 'Affiliation': 'Department of urology, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran. h_pakmanesh@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Abedinzadeh', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. abedinoro@yahoo.com.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. hormozkarami@yahoo.com.'}]",Urology journal,['10.22037/uj.v0i0.5314']
1423,31529097,Sitagliptin Decreases Visceral Fat and Blood Glucose in Women With Polycystic Ovarian Syndrome.,"CONTEXT


Women with polycystic ovarian syndrome (PCOS) have decreased growth hormone (GH), which can result in increased visceral adiposity (VAT) and impaired vascular function. GH-releasing hormone, a dipeptidyl peptidase-4 (DPP4) substrate, stimulates GH secretion.
OBJECTIVE


We tested the hypothesis that DPP4 inhibition increases GH and improves glucose levels and vascular function in women with PCOS.
METHODS


Eighteen women with PCOS participated in a double-blind, crossover study. They received sitagliptin either 100 mg or placebo daily for 1 month, with crossover treatments separated by an 8-week washout. During each treatment, women underwent a 75-gram oral glucose tolerance test (OGTT) and assessments of vascular function and body composition. Overnight GH secretion was assessed via venous sampling every 10 minutes for 12 hours and analyzed using an automated deconvolution algorithm.
RESULTS


During OGTT, sitagliptin increased glucagon-like peptide-1 (P < 0.001), early insulin secretion (from mean [± SD] insulinogenic index 1.9 ± 1.2 to 3.2 ± 3.1; P = 0.02), and decreased peak glucose (mean -17.2 mg/dL [95% CI, -27.7 to -6.6]; P < 0.01). At 1 month, sitagliptin decreased VAT (from 1141.9 ± 700.7 to 1055.1 ± 710.1 g; P = 0.02) but did not affect vascular function. Sitagliptin increased GH half-life (from 13.9 ± 3.6 to 17.0 ± 6.8 min, N = 16; P = 0.04) and interpulse interval (from 53.2 ± 20.0 to 77.3 ± 38.2 min, N = 16; P < 0.05) but did not increase mean overnight GH (P = 0.92 vs placebo).
CONCLUSIONS


Sitagliptin decreased the maximal glucose response to OGTT and VAT. Sitagliptin did not increase overnight GH but increased GH half-life and the interpulse interval.
CLINICAL TRIAL REGISTRATION


This study was registered at www.clinicaltrials.gov as NCT02122380 prior to enrollment of the first participant.",2020,"During OGTT, sitagliptin increased GLP-1 (p<0.001), early insulin secretion (from mean insulinogenic index 1.9±1.2 (SD) to 3.2±3.1; p=0.02) and decreased peak glucose (mean -17.2 mg/dL","['Women with polycystic ovarian syndrome (PCOS', 'women with PCOS', 'women with polycystic ovarian syndrome', 'Eighteen women with PCOS participated in a double-blinded, cross-over study']","['75-gram oral glucose tolerance test (OGTT', 'Sitagliptin', 'sitagliptin 100 mg vs. placebo']","['GLP-1 (p<0.001), early insulin secretion', 'visceral fat and blood glucoses', 'maximal glucose response', 'overnight GH levels', 'peak glucose', 'Overnight GH secretion', 'glucose levels and vascular function', 'mean overnight GH', 'interpulse interval', 'sitagliptin decreased VAT', 'Sitagliptin increased GH half-life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",18.0,0.187824,"During OGTT, sitagliptin increased GLP-1 (p<0.001), early insulin secretion (from mean insulinogenic index 1.9±1.2 (SD) to 3.2±3.1; p=0.02) and decreased peak glucose (mean -17.2 mg/dL","[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Devin', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Nian', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Celedonio', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wright', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz028']
1424,32424022,Whole-Grain Processing and Glycemic Control in Type 2 Diabetes: A Randomized Crossover Trial.,"OBJECTIVE


To consider the effects of whole-grain processing, specifically milling, on glycemic control in free-living adults with type 2 diabetes.
RESEARCH DESIGN AND METHODS


Participants of this crossover trial were randomized to two interventions of 2 weeks, separated by washout. They were advised to replace the grain foods they normally consumed with intervention foods. Intervention foods were nutrient-matched whole-grain products of wheat, oats, and brown rice that differed in their degree of processing. No other lifestyle advice was given. Continuous glucose monitoring systems were worn. Other cardiometabolic risk factors and alkylresorcinols (a biomarker of whole-grain intake) were measured pre- and postintervention.
RESULTS


Thirty-one adults with type 2 diabetes (63 ± 13 years old, BMI 32.4 ± 7 kg/m 2 , HbA 1c  7.5 ± 3.4% [59 ± 14 mmol/mol]) commenced the trial; 28 (90%) completed both interventions. The increase in alkylresorcinols did not differ between interventions, and there was no difference in reported energy intake. Postprandial responses were 9% (95% CI 3-15) lower following breakfast and 6% (1-10) lower following all meals of less-processed whole grains when compared with finely milled grains. Day-long glycemic variability also was reduced when measured by 24-h SD (-0.16 mmol/L [95% CI -0.25 to -0.06]) and mean amplitude of glycemic excursion (-0.36 [95% CI -0.65 to -0.08]). Mean change in body weight differed by 0.81 kg (95% CI 0.62-1.05) between interventions, increasing during the finely milled intervention and decreasing during the less-processed whole-grain intervention. This was not a mediating factor for the glycemic variables considered.
CONCLUSIONS


Consuming less-processed whole-grain foods over 2 weeks improved measures of glycemia in free-living adults with type 2 diabetes compared with an equivalent amount of whole-grain foods that were finely milled. Dietary advice should promote the consumption of minimally processed whole grains.",2020,"The increase in alkylresorcinols did not differ between interventions, and there was no difference in reported energy intake.","['Type 2 Diabetes', 'free-living adults with type 2 diabetes', 'Thirty-one adults with type 2 diabetes (63 ± 13 years old, BMI 32.4 ± 7 kg/m 2 , HbA 1c  7.5 ± 3.4% [59 ± 14 mmol/mol]) commenced the trial; 28 (90%) completed both interventions']","['whole-grain processing, specifically milling']","['glycemia', 'reported energy intake', 'mean amplitude of glycemic excursion', 'Mean change in body weight', 'Postprandial responses', 'alkylresorcinols']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0599997', 'cui_str': 'Mill'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}]",31.0,0.0556802,"The increase in alkylresorcinols did not differ between interventions, and there was no difference in reported energy intake.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Åberg', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Neumann', 'Affiliation': 'Department of Pathology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'AgResearch, Lincoln University, Lincoln, New Zealand.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Reynolds', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand andrew.reynolds@otago.ac.nz.'}]",Diabetes care,['10.2337/dc20-0263']
1425,31314050,Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Limited evidence is available regarding the benefit and hazard of higher-intensity treatment to lower lipid levels among patients 75 years or older. As a result, guideline recommendations differ for this age group compared with younger patients.
Objective


To determine the effect on outcomes and risks of combination ezetimibe and simvastatin compared with simvastatin monotherapy to lower lipid levels among patients 75 years or older with stabilized acute coronary syndrome (ACS).
Design, Setting, Participants


In this prespecified secondary analysis of the global, multicenter, prospective clinical randomized Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), outcomes and risks were compared by age among patients 50 years or older after a hospitalization for ACS. Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014. Data were analyzed May 29, 2015, through March 13, 2018, using Kaplan-Meier curves and Cox proportional hazards models.
Interventions


Double-blind randomized assignment to combined simvastatin and ezetimibe or simvastatin and placebo with follow-up for a median of 6 years (interquartile range, 4.3-7.1 years).
Main Outcomes and Measures


The primary composite end point consisted of death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days. Individual adverse ischemic and safety end points and lipid variables were also analyzed.
Results


Of 18 144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization. Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction). The rate of adverse events did not increase with simvastatin-ezetimibe vs simvastatin-placebo among younger or older patients.
Conclusions and Relevance


In IMPROVE-IT, patients hospitalized for ACS derived benefit from higher-intensity therapy to lower lipid levels with simvastatin-ezetimibe compared with simvastatin monotherapy, with the greatest absolute risk reduction among patients 75 years or older. Addition of ezetimibe to simvastatin was not associated with any significant increase in safety issues among older patients. These results may have implications for guideline recommendations regarding lowering of lipid levels in the elderly.
Trial Registration


ClinicalTrials.gov identifier: NCT00202878.",2019,"Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction).","['patients 75 years or older', 'median of 6 years (interquartile range, 4.3-7.1 years', 'patients 75 years or older with stabilized acute coronary syndrome (ACS', 'patients 50 years or older after a hospitalization for ACS', 'Participants', 'older patients', 'Results\n\n\nOf 18\u202f144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization', 'Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014', 'Patients 75 Years or Older', 'younger or older patients']","['Simvastatin-Ezetimibe', 'simvastatin-placebo', 'combination ezetimibe and simvastatin', 'simvastatin-ezetimibe', 'simvastatin-ezetimibe vs simvastatin-placebo', 'ezetimibe to simvastatin', 'simvastatin monotherapy', 'Simvastatin Monotherapy', 'combined simvastatin and ezetimibe or simvastatin and placebo']","['rate of adverse events', 'Individual adverse ischemic and safety end points and lipid variables', 'lipid levels', 'death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532737', 'cui_str': 'ezetimibe / Simvastatin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",,0.259567,"Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction).","[{'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Bach', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Blazing', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2306']
1426,22674146,"Chemotherapy (CT) and hormonotherapy (HT) as neoadjuvant treatment in luminal breast cancer patients: results from the GEICAM/2006-03, a multicenter, randomized, phase-II study.","BACKGROUND


Luminal breast cancer is a highly endocrine responsive disease. However, the therapeutic benefit of chemotherapy (CT) in this population is not fully characterized. This study investigates the value of CT and hormone therapy (HT) in luminal breast cancer patients in the neoadjuvant setting.
PATIENTS AND METHODS


Patients with operable breast cancer and immunophenotypically defined luminal disease (ER+/PR+/HER2-/cytokeratin 8/18+) were recruited. Patients were randomized to CT (epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) 4 cycles followed by docetaxel 100 mg/m(2 )4 cycles [EC-T]) or HT (exemestane 25 mg daily 24 weeks [combined with goserelin in premenopausal patients]). The primary end point was the clinical response measured by magnetic resonance imaging.
RESULTS


Ninety-five patients were randomized (47 CT, 48 HT). The clinical response rate was 66% for CT and 48% for HT (P = 0.075). We performed an unplanned analysis based on Ki67 levels (cut-off of 10%). Similar clinical response was seen between arms in patients with low Ki67 (CT: 63%, HT: 58%; P = 0.74); patients with high Ki67 had a better response with CT (67 versus 42%; P = 0.075). Grade 3/4 toxicity was more frequent with CT.
CONCLUSIONS


Luminal immunophenotype is not enough to identify patients who do not benefit from neoadjuvant CT. Luminal patients with low proliferation index could potentially avoid CT.",2012,"Similar clinical response was seen between arms in patients with low Ki67 (CT: 63%, HT: 58%; P = 0.74); patients with high Ki67 had a better response with CT (67 versus 42%; P = 0.075).","['premenopausal patients', 'Patients with operable breast cancer and immunophenotypically defined luminal disease (ER+/PR+/HER2-/cytokeratin 8/18+) were recruited', 'luminal breast cancer patients', 'Ninety-five patients', 'Luminal patients with low proliferation index could potentially avoid CT', 'luminal breast cancer patients in the neoadjuvant setting']","['CT and hormone therapy (HT', 'chemotherapy (CT', 'CT (epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) 4 cycles followed by docetaxel 100 mg/m(2 )4 cycles [EC-T]) or HT (exemestane 25 mg daily 24 weeks [combined with goserelin', 'Chemotherapy (CT) and hormonotherapy (HT']","['clinical response measured by magnetic resonance imaging', 'Grade 3/4 toxicity', 'clinical response rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1592266', 'cui_str': 'exemestane 25 MG [Aromasin]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",95.0,0.0432233,"Similar clinical response was seen between arms in patients with low Ki67 (CT: 63%, HT: 58%; P = 0.74); patients with high Ki67 had a better response with CT (67 versus 42%; P = 0.075).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alba', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga. Electronic address: ealbac@uma.es.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Calvo', 'Affiliation': 'Department of Medical Oncology, C H U Juan Canalejo, A Coruna.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albanell', 'Affiliation': 'Department of Medical Oncology, H del Mar, Barcelona.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'De la Haba', 'Affiliation': 'Department of Medical Oncology, Hospital Reina Sofia, Cordoba.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arcusa Lanza', 'Affiliation': 'Department of Medical Oncology, Consorci Sanitari de Terrassa, Barcelona.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Chacon', 'Affiliation': 'Department of Medical Oncology, H Virgen de la Salud, Toledo.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sanchez-Rovira', 'Affiliation': 'Department of Medical Oncology, C H de Jaen, Jaen.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Plazaola', 'Affiliation': 'Department of Medical Oncology, Onkologikoa, Donostia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Lopez Garcia-Asenjo', 'Affiliation': 'Department of Medical Oncology, H C U San Carlos, Madrid.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Department of Medical Oncology, Hospital Clinico Universitario, Valencia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carrasco', 'Affiliation': 'GEICAM, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'Department of Medical Oncology, Hospital Clinico Universitario, Valencia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds132']
1427,31372864,The role of neuropsychological mechanisms in implementation intentions to reduce alcohol consumption among heavy drinkers: a randomized trial.,"Implementation intention formation, which involves identifying triggers and linking them with coping strategies, has proven effective at reducing alcohol consumption in general populations. For the first time, the present study tested the ability of implementation intentions to reduce alcohol consumption among heavy drinkers and to explore potential neuropsychological mechanisms. At baseline, participants were randomized to form implementation intentions or to an active control group. There was a 5.7 unit (1 unit = 10 ml or 8 g ethanol) per week reduction ([95%CI 0.15, 11.19], p = 0.048) in alcohol consumption at 1 month follow-up among participants who formed implementation intentions, which was significantly more than controls F(1, 91) = 3.95, p = 0.048, a medium effect size (d = 0.47, Cohen, 1992). No significant differences in performance on the neuropsychological tasks were found between groups. The present study demonstrates for the first time that implementation intentions reduce alcohol consumption among heavy drinkers.",2020,No significant differences in performance on the neuropsychological tasks were found between groups.,['heavy drinkers'],['10\xa0ml or 8\xa0g ethanol'],"['performance on the neuropsychological tasks', 'alcohol consumption']","[{'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",,0.0398301,No significant differences in performance on the neuropsychological tasks were found between groups.,"[{'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK. elly.mcgrath@manchester.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Millar', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Armitage', 'Affiliation': 'Division of Psychology and Mental Health, Manchester Centre for Health Psychology, Manchester Academic Health Science Centre, United Kingdom and NIHR Manchester Biomedical Research Centre and NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester, UK.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00078-5']
1428,32430457,"Effects of an Electronic Software ""Prompt"" With Health Care Professional Training on Cardiovascular and Renal Complications in a Multiethnic Population With Type 2 Diabetes and Microalbuminuria (the GP-Prompt Study): Results of a Pragmatic Cluster-Randomized Trial.","OBJECTIVE


Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes mellitus (T2DM) and microalbuminuria. The effects of using an electronic ""prompt"" with a treatment algorithm to support a treat-to-target approach has not been tested in primary care.
RESEARCH DESIGN AND METHODS


A multicenter, cluster-randomized trial was conducted among primary care practices across Leicestershire, U.K. The primary outcome was the proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80 mmHg, respectively) and total cholesterol (<3.5 mmol/L) targets at 24 months. Secondary outcomes included proportion of individuals with HbA 1c  <58 mmol/mol (<7.5%), changes in prescribing, change in the albumin-to-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality, and coding accuracy.
RESULTS


A total of 2,721 individuals from 22 practices, mean age 63 years, 41% female, and 62% from black and minority ethnic groups completed 2 years of follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the prespecified outcome of total cholesterol <4.0 mmol/L (odds ratio 1.24; 95% CI 1.05-1.47;  P  = 0.01) increased with intensive intervention compared with control. Coding for microalbuminuria increased relative to control (odds ratio 2.05; 95% CI 1.29-3.25;  P  < 0.01).
CONCLUSIONS


Greater improvements in composite cardiovascular risk factor control with this intervention compared with standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies, including patient education and health care professional engagement, in the management of T2DM.",2020,"Coding for microalbuminuria increased relative to control (odds ratio 2.05; 95% CI 1.29-3.25;  P  < 0.01).
","['Multiethnic Population With Type 2 Diabetes and Microalbuminuria (the GP-Prompt Study', 'primary care practices across Leicestershire, U.K', '2,721 individuals from 22 practices, mean age 63 years, 41% female, and 62% from black and minority ethnic groups completed 2 years of follow-up', 'individuals with type 2 diabetes (T2DM) and microalbuminuria']","['Electronic Software ""Prompt"" With Health Care Professional Training']","['proportion of individuals with HbA 1c  <58 mmol/mol', 'total cholesterol', 'Cardiovascular and Renal Complications', 'changes in prescribing, change in the albumin-to-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality, and coding accuracy', 'proportion of individuals achieving systolic and diastolic blood pressure', 'lipid profile', 'composite cardiovascular risk factor control']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0454863', 'cui_str': 'Leicestershire'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",2721.0,0.0749131,"Coding for microalbuminuria increased relative to control (odds ratio 2.05; 95% CI 1.29-3.25;  P  < 0.01).
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Willis', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Crasto', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dallosso', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Waheed', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Seidu', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K. kk22@le.ac.uk.'}]",Diabetes care,['10.2337/dc19-2243']
1429,31531959,Stepping up early treatment for help-seeking youth with at-risk mental states: Feasibility and acceptability of a real-world exercise program.,"INTRODUCTION


Youth with at-risk mental states (ARMS) have low levels of physical activity (PA), reduced fitness levels and experience poor sleep quality. These lifestyle factors exacerbate mental health symptoms and increase cardiometabolic disease risk. PA interventions can help prevent this decline in physical health whilst reducing mental health symptom severity. Whether PA interventions are feasible and acceptable amongst youth with ARMS is unclear.
METHODS


This study evaluated the feasibility and acceptability of headspace Active, a pragmatic PA program offered to 14 to 25 year olds with ARMS. The 12-week exercise physiologist-led intervention was conducted in adjunct to usual care. Feasibility was determined by number of referrals, attendance, engagement in exercise sessions and dropout from the intervention. Acceptability was assessed by a 10-item questionnaire. Secondary outcomes included anthropometry, cardiorespiratory fitness and strength. Subjective PA levels, symptoms of depression and anxiety, sleep, motivation and quality of life were also assessed.
RESULTS


Within 12 months, 77% of referrals completed the 12-week intervention (n = 20), with six dropouts. Of the 20 ""completers"", 95% attended at least five sessions over the 12-week intervention. Participants found the program highly acceptable (mean = 41.2/50 on the 10-item acceptability questionnaire) and experienced significant improvements in PA, strength, motivation, depressive symptoms and sleep quality post-intervention. No changes in anthropometry were observed.
CONCLUSION


Results suggest headspace Active was feasible and acceptable and was associated with improvements in physical and mental health outcomes among ARMS youth. Given the potential scalability of this real-world PA program to other youth mental health settings, these data have implications for best practice implementation of PA interventions for individuals with emerging mental illness.",2020,"No changes in anthropometry were observed.
","['individuals with emerging mental illness', '14 to 25 year olds with ARMS', 'help-seeking youth with at-risk mental states']","['Stepping up early treatment', 'real-world exercise program', 'PA interventions', 'exercise physiologist-led intervention']","['10-item acceptability questionnaire', 'physical and mental health outcomes', 'PA, strength, motivation, depressive symptoms and sleep quality post-intervention', 'anthropometry, cardiorespiratory fitness and strength', 'Subjective PA levels, symptoms of depression and anxiety, sleep, motivation and quality of life', 'Acceptability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}]","[{'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0260141', 'cui_str': 'Physiologist (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}]",,0.0340962,"No changes in anthropometry were observed.
","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Lederman', 'Affiliation': 'Keeping the Body In Mind, South Eastern Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Ward', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Maloney', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Keeping the Body In Mind, South Eastern Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Teasdale', 'Affiliation': 'Keeping the Body In Mind, South Eastern Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Morell', 'Affiliation': 'Keeping the Body In Mind, South Eastern Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Keeping the Body In Mind, South Eastern Sydney Local Health District, Sydney, New South Wales, Australia.'}]",Early intervention in psychiatry,['10.1111/eip.12871']
1430,31533783,"The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial.","BACKGROUND


Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial.
METHODS/DESIGN


We will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding.
DISCUSSION


Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems.
TRIAL REGISTRATION


Both trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).",2019,The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India.,"['school-going adolescents with common mental health problems in India', 'six Government-run secondary schools in New Delhi', '240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated distress/impairment']","['classroom-based sensitization intervention', 'classroom-based sensitization intervention over\xa0and above school-level sensitization activities', 'low-intensity problem-solving intervention', 'school-based psychological intervention', 'brief problem-solving intervention delivered over 3\u2009weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control']","['distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",240.0,0.370344,The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India.,"[{'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, Brighton, BN1 9RH, UK.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Malik', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Shinde', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Hoogendoorn', 'Affiliation': 'Amsterdam UMC, Amsterdam Public Health research institute, Vrije Universitiet, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Ruwaard', 'Affiliation': 'Amsterdam UMC, Amsterdam Public Health research institute, Vrije Universitiet, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Krishna', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Bhat', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Rooplata', 'Initials': 'R', 'LastName': 'Sahu', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India.'}, {'ForeName': 'Paulomi', 'Initials': 'P', 'LastName': 'Sudhir', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore, Karnataka, 560029, India.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, Maple House, 149 Tottenham Court Rd, London, W1T 7NF, UK.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, van der Boechorstraat 1, 1081, BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, 3227 Franz Hall, Los Angeles, CA, 90095-1563, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'University Department of Psychiatry, Warneford Hospital, Oxford, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India. Vikram_Patel@hms.harvard.edu.'}]",Trials,['10.1186/s13063-019-3573-3']
1431,31522033,Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours.,"BACKGROUND


Brivanib is a selective inhibitor of vascular endothelial growth factor and fibroblast growth factor (FGF) signalling. We performed a phase II randomised discontinuation trial of brivanib in 7 tumour types (soft-tissue sarcomas [STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer and transitional cell carcinoma [TCC]).
PATIENTS AND METHODS


During a 12-week open-label lead-in period, patients received brivanib 800 mg daily and were evaluated for FGF2 status by immunohistochemistry. Patients with stable disease at week 12 were randomised to brivanib or placebo. A study steering committee evaluated week 12 response to determine if enrolment in a tumour type would continue. The primary objective was progression-free survival (PFS) for brivanib versus placebo in patients with FGF2-positive tumours.
RESULTS


A total of 595 patients were treated, and stable disease was observed at the week 12 randomisation point in all tumour types. Closure decisions were made for breast cancer, pancreatic cancer, NSCLC, gastric cancer and TCC. Criteria for expansion were met for STS and ovarian cancer. In 53 randomised patients with STS and FGF2-positive tumours, the median PFS was 2.8 months for brivanib and 1.4 months for placebo (hazard ratio [HR]: 0.58, p = 0.08). For all randomised patients with sarcomas, the median PFS was 2.8 months (95% confidence interval [CI]: 1.4-4.0) for those treated with brivanib compared with 1.4 months (95% CI: 1.3-1.6) for placebo (HR = 0.64, 95% CI: 0.38-1.07; p = 0.09). In the 36 randomised patients with ovarian cancer and FGF2-positive tumours, the median PFS was 4.0 (95% CI: 2.6-4.2) months for brivanib and 2.0 months (95% CI: 1.2-2.7) for placebo (HR: 0.56, 95% CI: 0.26-1.22). For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11).
CONCLUSION


Brivanib demonstrated activity in STS and ovarian cancer with an acceptable safety profile. FGF2 expression, as defined in the protocol, is not a predictive biomarker of the efficacy of brivanib.",2019,"For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11).
","['Patients with stable disease at week 12', '595 patients', '36 randomised patients with ovarian cancer and FGF2-positive tumours', '7 tumour types (soft-tissue sarcomas\xa0[STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer\xa0and transitional cell carcinoma [TCC', '53 randomised patients with STS and FGF2-positive tumours', 'patients with FGF2-positive tumours', 'patients with advanced solid tumours']","['brivanib or placebo', 'brivanib', 'placebo', 'brivanib 800\xa0mg daily and were evaluated for FGF2 status by immunohistochemistry', 'brivanib versus placebo']","['progression-free survival (PFS', 'median PFS', 'FGF2 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C2700604', 'cui_str': 'brivanib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",595.0,0.421179,"For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11).
","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom. Electronic address: robin.jones4@nhs.net.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lillian L', 'Initials': 'LL', 'LastName': 'Siu', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': 'Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Medioni', 'Affiliation': 'Hôpital Européen Georges Pompidou, Paris, France; Paris-Descartes University, Paris, France.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'DeJonge', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rudin', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sawyer', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Khayat', 'Affiliation': 'Petrie-Salpetriere Hospital, Paris, France.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Judith M P G M', 'Initials': 'JMPGM', 'LastName': 'de Vos-Geelen', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'T R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Obel', 'Affiliation': 'North Shore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Brockstein', 'Affiliation': 'North Shore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'DeGreve', 'Affiliation': 'University Hospital Brussels, Brussels, Belgium.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Baurain', 'Affiliation': 'Centre du Cancer, Cu Saint-Luc/UCL, Brussels, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Maki', 'Affiliation': 'Monter Cancer Center, Lake Success, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Adamo"", 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ Previously Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dickson', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Undevia', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Geary', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Janisch', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Albiruni R', 'Initials': 'AR', 'LastName': 'Abdul Razak', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Vitfell-Rasmussen', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Walters', 'Affiliation': 'Intensity Therapeutics Inc, Westport, CT Previously BMS, USA.'}, {'ForeName': 'Stan B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.024']
1432,31870463,Enzymatically modified isoquercitrin improves endothelial function in volunteers at risk of cardiovascular disease.,"A higher intake of food rich in flavonoids such as quercetin can reduce the risk of CVD. Enzymatically modified isoquercitrin (EMIQ®) has a bioavailability 17-fold higher than quercetin aglycone and has shown potential CVD moderating effects in animal studies. The present study aimed to determine whether acute ingestion of EMIQ® improves endothelial function, blood pressure (BP) and cognitive function in human volunteers at risk of CVD. Twenty-five participants (twelve males and thirteen females) with at least one CVD risk factor completed this randomised, controlled, crossover study. In a random order, participants were given EMIQ® (2 mg aglycone equivalent)/kg body weight or placebo alongside a standard breakfast meal. Endothelial function, assessed by flow-mediated dilatation (FMD) of the brachial artery was measured before and 1·5 h after intervention. BP, arterial stiffness, cognitive function, BP during cognitive stress and measures of quercetin metabolites, oxidative stress and markers of nitric oxide (NO) production were assessed post-intervention. After adjustment for pre-treatment measurements and treatment order, EMIQ® treatment resulted in a significantly higher FMD response compared with the placebo (1·80 (95 % CI 0·23, 3·37) %; P = 0·025). Plasma concentrations of quercetin metabolites were significantly higher (P < 0·001) after EMIQ® treatment compared with the placebo. No changes in BP, arterial stiffness, cognitive function or biochemical parameters were observed. In this human intervention study, the acute administration of EMIQ® significantly increased circulating quercetin metabolites and improved endothelial function. Further clinical trials are required to assess whether health benefits are associated with long-term EMIQ® consumption.",2020,Plasma concentrations of quercetin metabolites were significantly higher (P < 0·001) after EMIQ® treatment compared with the placebo.,"['human volunteers at risk of CVD', 'volunteers at risk of cardiovascular disease', 'Twenty-five participants (twelve males and thirteen females) with at least one CVD risk factor']","['EMIQ® (2 mg aglycone equivalent)/kg body weight or placebo alongside a standard breakfast meal', 'EMIQ®', 'placebo', 'Enzymatically modified isoquercitrin (EMIQ®', 'Enzymatically modified isoquercitrin']","['BP, arterial stiffness, cognitive function or biochemical parameters', 'endothelial function, blood pressure (BP) and cognitive function', 'circulating quercetin metabolites and improved endothelial function', 'Endothelial function, assessed by flow-mediated dilatation (FMD) of the brachial artery', 'Plasma concentrations of quercetin metabolites', 'FMD response', 'endothelial function', 'BP, arterial stiffness, cognitive function, BP during cognitive stress and measures of quercetin metabolites, oxidative stress and markers of nitric oxide (NO) production']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C0304518', 'cui_str': 'Aglycone'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0064071', 'cui_str': 'quercetin 3-(beta-D-glucofuranoside)'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0033268'}]",25.0,0.168715,Plasma concentrations of quercetin metabolites were significantly higher (P < 0·001) after EMIQ® treatment compared with the placebo.,"[{'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}, {'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ward', 'Affiliation': 'School of Public Health and Curtin Health Innovation Research Institute, Curtin University, Perth, 6102 Western Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Centre for Epidemiology and Biostatistics, School of Public Health, FlindersUniversity of South Australia, Adelaide, 5042 South Australia, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Croft', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519002137']
1433,31801814,Extremely Preterm Infants Have Significant Alterations in Their Conventional T Cell Compartment during the First Weeks of Life.,"Extremely preterm neonates are particularly susceptible to infections, likely because of severely impaired immune function. However, little is known on the composition of the T cell compartment in early life in this vulnerable population. We conducted a comprehensive phenotypic flow cytometry-based longitudinal analysis of the peripheral conventional T cell compartment of human extremely low gestational age neonates (ELGAN) with extremely low birth weight (ELBW; <1000 g) participating in a randomized placebo-controlled study of probiotic supplementation. PBMCs from ELGAN/ELBW neonates were collected at day 14, day 28, and postmenstrual week 36. Comparisons were made with full-term 14-d-old neonates. Total CD4 +  and CD8 +  T cell frequencies were markedly lower in the preterm neonates. The reduction was more pronounced among the CD8 +  population, resulting in an increased CD4/CD8 ratio. The preterm infants were also more Th2 skewed than the full-term infants. Although the frequency of regulatory T cells seemed normal in the ELGAN/ELBW preterm neonates, their expression of the homing receptors α4β7, CCR4, and CCR9 was altered. Notably, ELGAN/ELBW infants developing necrotizing enterocolitis before day 14 had higher expression of CCR9 in CD4 + T cells at day 14. Chorioamnionitis clearly associated with reduced T regulatory cell frequencies and functional characteristics within the preterm group. Finally, probiotic supplementation with  Lactobacillus reuteri  did not impose any phenotypic changes of the conventional T cell compartment. In conclusion, notable immaturities of the T cell compartment in ELGAN/ELBW neonates may at least partially explain their increased susceptibility to severe immune-mediated morbidities.",2020,"Notably, ELGAN/ELBW infants developing necrotizing enterocolitis before day 14 had higher expression of CCR9 in CD4 + T cells at day 14.",['human extremely low gestational age neonates (ELGAN) with extremely low birth weight (ELBW; <1000 g) participating in a randomized'],"['placebo', 'probiotic supplementation']","['necrotizing enterocolitis', 'Total CD4 +  and CD8 +  T cell frequencies', 'CD4/CD8 ratio', 'reduced T regulatory cell frequencies and functional characteristics']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.122672,"Notably, ELGAN/ELBW infants developing necrotizing enterocolitis before day 14 had higher expression of CCR9 in CD4 + T cells at day 14.","[{'ForeName': 'Khaleda Rahman', 'Initials': 'KR', 'LastName': 'Qazi', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, 106 91 Stockholm, Sweden; qazi.khaleda.rahman@su.se.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Bach Jensen', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, 581 83 Linköping, Sweden.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'van der Heiden', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Björkander', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Holmlund', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Yeneneh', 'Initials': 'Y', 'LastName': 'Haileselassie', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Efthymia', 'Initials': 'E', 'LastName': 'Kokkinou', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Marchini', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, 171 77 Stockholm, Sweden.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, 581 83 Linköping, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Abrahamsson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, 581 83 Linköping, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Sverremark-Ekström', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, 106 91 Stockholm, Sweden.'}]","Journal of immunology (Baltimore, Md. : 1950)",['10.4049/jimmunol.1900941']
1434,20737683,[Study of tolerability and reactogenicity of pandemic vaccines against influenza type A/H1N1].,"AIM


To study tolerability and safety of pandemic vaccines against influenza A/H1N1 ""INFLUVIR"" and ""PANDEFLU"" on limited group of volunteers during phase I clinical trial.
MATERIALS AND METHODS


Thirty healthy volunteers were participated in phase I clinical trial. Clinical and laboratory tests of volunteers randomized to 2 groups (20 persons received vaccine and 10 persons - placebo) were performed. ""INFLUVIR"" vaccine was administered by intranasal route. Volunteers were hospitalized and followed up for development of local and systemic adverse events during 7 days after vaccination. ""PANDEFLU"" was administered intramuscularly; vaccinees were followed for 7 days in outpatient settings. RESULTS. Phase I clinical trial showed good tolerability and low reactogenicity of ""INFLUVIR"" and ""PANDEFLU"" vaccines. There were no moderate and severe local and systemic adverse events registered.
CONCLUSION


On the basis of performed phase I clinical trial, phase II trial was recommended to perform in order to assess the reactogenicity, safety and immunogenicity of studied vaccines.",2010,"There were no moderate and severe local and systemic adverse events registered.
","['Thirty healthy volunteers', 'volunteers randomized to 2 groups (20 persons received']","['INFLUVIR"" and ', 'pandemic vaccines against influenza A/H1N1 ""INFLUVIR"" and ', 'vaccine and 10 persons - placebo', 'pandemic vaccines against influenza type A/H1N1']","['tolerability and reactogenicity', 'reactogenicity, safety and immunogenicity', 'moderate and severe local and systemic adverse']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C2934816', 'cui_str': 'Influvir'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]",30.0,0.0394403,"There were no moderate and severe local and systemic adverse events registered.
","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Mironov', 'Affiliation': ''}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Bushmenkov', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Dyldina', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Romanova', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Tsaan', 'Affiliation': ''}, {'ForeName': 'O I', 'Initials': 'OI', 'LastName': 'Kiselev', 'Affiliation': ''}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Erofeeva', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Stukova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1435,20465002,[Clinical trial of safety and immunogenicity of new influenza vaccine Grifor in children].,"AIM


Assessment of reactogenicity, safety and immunogenicity after single intramuscular immunization of children with Grifor vaccine.
MATERIALS AND METHODS


Reactogenicity, safety, and immunogenicity of Grifor vaccine compared with Vaxigrip vaccine was evaluated during phase III clinical trial in the Institute of Influenza. Thirty-six children aged 12 - 17 years, divided on 2 groups, participated in single blind comparative prospective randomized trial. Seroconversion factor, seroconversion and seroprotection levels were evaluated by hemagglutination inhibition assay.
RESULTS


Results of study of systemic and local reactogenicity in children during first 7 days after immunization with Grifor and Vaxigrip vaccine showed good tolerability, areactogenicity and safety of both vaccines. Complete blood count, serum biochemistry and urinalysis results as well as serum IgE level did not change after vaccination. After immunization with Grifor vaccine, seroconversion rate to influenza virus subtypes A/H1N1, A/H3N2, and B was 70%, 50%, and 70% respectively, seroprotection rate--90%, 80%, and 85% respectively, and seroconversion factor--6.5, 2.7, and 4.0 respectively.
CONCLUSION


This trial, which was performed in tightly controlled conditions, had demonstrated that Grifor vaccine is safe and highly immunogenic against influenza viruses A and B and satisfies criteria of both Federal Service for Surveillance for Protection of Consumers Rights and Human Welfare and CHMP of EMA. Obtained results allow to recommend the Grifor vaccine for use in pediatric practice according to national immunization schedule.",2010,"After immunization with Grifor vaccine, seroconversion rate to influenza virus subtypes A/H1N1, A/H3N2, and B was 70%, 50%, and 70% respectively, seroprotection rate--90%, 80%, and 85% respectively, and seroconversion factor--6.5, 2.7, and 4.0 respectively.
","['Thirty-six children aged 12 - 17 years', 'children with Grifor vaccine', 'children']","['Grifor and Vaxigrip vaccine', 'Vaxigrip vaccine', 'Grifor vaccine', 'new influenza vaccine Grifor']","['Complete blood count, serum biochemistry and urinalysis results', 'seroprotection rate--90', 'good tolerability, areactogenicity and safety', 'Seroconversion factor, seroconversion and seroprotection levels', 'reactogenicity, safety and immunogenicity', 'seroconversion rate', 'serum IgE level']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2715804', 'cui_str': 'Grifor'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C2715804', 'cui_str': 'Grifor'}, {'cui': 'C1312593', 'cui_str': 'vaxigrip'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}]",36.0,0.0479548,"After immunization with Grifor vaccine, seroconversion rate to influenza virus subtypes A/H1N1, A/H3N2, and B was 70%, 50%, and 70% respectively, seroprotection rate--90%, 80%, and 85% respectively, and seroconversion factor--6.5, 2.7, and 4.0 respectively.
","[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Erofeeva', 'Affiliation': ''}, {'ForeName': 'S Ia', 'Initials': 'SIa', 'LastName': ""Mel'nikov"", 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Semchenko', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Korovkin', 'Affiliation': ''}, {'ForeName': 'I Iu', 'Initials': 'IIu', 'LastName': 'Nikonorov', 'Affiliation': ''}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Maksakova', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Voĭtsekhovskaia', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Erman', 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Gonchar', 'Affiliation': ''}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Pozdeev', 'Affiliation': ''}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Drinevskiĭ', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1436,31811645,Adjunctive use of enamel matrix derivatives to porcine-derived xenograft for the treatment of one-wall intrabony defects: Two-year longitudinal results of a randomized controlled clinical trial.,"BACKGROUND


The purpose of this study was to evaluate the potential advantages of adjunctive use of enamel matrix protein derivative (EMD) in combination with demineralized porcine bone matrix (DPBM) for the treatment of one-wall intrabony defects in the molar regions, in comparison with the use of DPBM alone, through a randomized controlled clinical trial.
METHODS


Forty-two participants were randomly assigned to two groups: one where DPBM with the adjunctive use of EMD (test group, n = 20) was applied and the other without EMD (control group, n = 22). Changes in the clinical and radiographic parameters from baseline at 6, 12, and 24 months were measured (probing pocket depth, clinical attachment loss, defect depth, and defect width). Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (dehiscence/fenestration, persistent swelling, spontaneous bleeding, and ulceration) were also assessed.
RESULTS


Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events. However, no statistically significant differences in any of the measured parameters were found when the two groups were compared. Early wound healing outcomes and the severity of swelling did not differ between the groups, but the severity of pain (P = 0.046), duration (P = 0.033), and swelling (P = 0.022) were significantly lower in the test group.
CONCLUSIONS


DPBM has been verified for biocompatibility and can be used as a scaffold to enhance the clinical and radiographic outcomes of periodontal regeneration of one-wall intrabony defects. In particular, the adjunctive use of EMD significantly reduced the postoperative discomfort.",2020,"Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events.",['Forty-two participants'],"['demineralized porcine bone matrix (DPBM', 'enamel matrix derivatives to porcine-derived xenograft', 'enamel matrix protein derivative (EMD', 'DPBM with the adjunctive use of EMD']","['severity of pain', 'Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (dehiscence/fenestration, persistent swelling, spontaneous bleeding, and ulceration', 'swelling', 'clinical attachment loss, defect depth, and defect width', 'clinical and radiographic outcomes', 'Early wound healing outcomes', 'postoperative discomfort', 'severity of swelling']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0005962', 'cui_str': 'Bone Matrix'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0522537', 'cui_str': 'Xenografts'}, {'cui': 'C0893442', 'cui_str': 'enamel matrix proteins'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0337280', 'cui_str': 'Fenestration - action (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]",42.0,0.0371864,"Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events.","[{'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}, {'ForeName': 'Do-Hyung', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}, {'ForeName': 'Seong-Nyum', 'Initials': 'SN', 'LastName': 'Jeong', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}]",Journal of periodontology,['10.1002/JPER.19-0432']
1437,19833819,"A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer.","BACKGROUND


Paclitaxel-carboplatin is used as the standard regimen for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was designed to compare gemcitabine + carboplatin or gemcitabine + paclitaxel to the standard regimen.
PATIENTS AND METHODS


A total of 1135 chemonaive patients with stage IIIB or IV NSCLC were randomly allocated to receive gemcitabine 1000 mg/m(2) on days 1 and 8 plus carboplatin area under the concentration-time curve (AUC) 5.5 on day 1 (GC), gemcitabine 1000 mg/m(2) on days 1 and 8 plus paclitaxel 200 mg/m(2) on day 1 (GP), or paclitaxel 225 mg/m(2) plus carboplatin AUC 6.0 on day 1 (PC). Stratification was based on disease stage, baseline weight loss, and presence or absence of brain metastases. Cycles were repeated every 21 days for up to six cycles or disease progression.
RESULTS


Median survival (months) with GC was 7.9 compared with 8.5 for GP and 8.7 for PC. Response rates (RRs) were as follows: GC, 25.3%; GP, 32.1%; and PC, 29.8%. The GC arm was associated with a greater incidence of grade 3 or 4 hematologic events but a lower rate of neurotoxicity and alopecia when compared with GP and PC.
CONCLUSIONS


Non-platinum and non-paclitaxel gemcitabine-containing doublets demonstrate similar overall survival and RR compared with the standard PC regimen. However, the treatment arms had distinct toxicity profiles.",2010,"The GC arm was associated with a greater incidence of grade 3 or 4 hematologic events but a lower rate of neurotoxicity and alopecia when compared with GP and PC.
","['1135 chemonaive patients with stage IIIB or IV NSCLC', 'patients with advanced or metastatic non-small-cell lung cancer', 'patients with advanced or metastatic non-small-cell lung cancer (NSCLC']","['gemcitabine', 'platinum and non-paclitaxel gemcitabine', 'carboplatin or paclitaxel versus paclitaxel plus carboplatin', 'Paclitaxel-carboplatin', 'gemcitabine 1000 mg/m(2) on days 1 and 8 plus carboplatin area under the concentration-time curve (AUC) 5.5 on day 1 (GC), gemcitabine 1000 mg/m(2) on days 1 and 8 plus paclitaxel 200 mg/m(2) on day 1 (GP), or paclitaxel 225 mg/m(2) plus carboplatin AUC', 'gemcitabine + carboplatin or gemcitabine + paclitaxel']","['incidence of grade 3 or 4 hematologic events', 'neurotoxicity and alopecia', 'overall survival and RR', 'Median survival', 'distinct toxicity profiles', 'disease stage, baseline weight loss, and presence or absence of brain metastases', 'Response rates (RRs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}]",1135.0,0.0455861,"The GC arm was associated with a greater incidence of grade 3 or 4 hematologic events but a lower rate of neurotoxicity and alopecia when compared with GP and PC.
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Treat', 'Affiliation': 'US Medical Division, Lilly USA, Indianapolis, IN. Electronic address: treatjo@lilly.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gonin', 'Affiliation': 'Westat, Rockville, MD.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'Division of Hematology/Oncology, Multidisciplinary Thoracic Oncology Group, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Division of Hematology/Oncology, University of Maryland Greenbaum Cancer Center, Baltimore, MD.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Catalano', 'Affiliation': 'Drexel University College of Medicine, Philadelphia, PA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Marinucci', 'Affiliation': 'Drexel University College of Medicine, Philadelphia, PA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ansari', 'Affiliation': 'Northern Indiana Cancer Research Consortium, South Bend, IN.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Gillenwater', 'Affiliation': 'Department of Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, VA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Rowland', 'Affiliation': 'Department of Medicine, Carle Clinic Cancer Center, Urbana, IL.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Comis', 'Affiliation': 'Drexel University College of Medicine, Philadelphia, PA.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Obasaju', 'Affiliation': 'US Medical Division, Lilly USA, Indianapolis, IN.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'Division of Hematology/Oncology, Penn State Hershey Cancer Institute, Hershey, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp352']
1438,31455824,"Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.",,2019,,['preterm infants'],"['placebo', 'Morphine']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.11121,,"[{'ForeName': 'Omri David', 'Initials': 'OD', 'LastName': 'Soffer', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA. Omri.soffer@childrens.harvard.edu.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelissen', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Berde', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0476-9']
1439,32430507,"Impact of Myc in HIV-associated Non-Hodgkin Lymphomas Treated with EPOCH, and Outcomes with Vorinostat (AMC075 Trial).","EPOCH is a preferred regimen for HIV-NHLs, which are frequently EBV+ or HHV-8+. The histone deacetylase (HDAC) inhibitor vorinostat disrupts EBV/HHV-8 latency, enhances chemotherapy-induced cell death, and may clear HIV reservoirs. To assess whether vorinostat increases EPOCH efficacy and/or HIV clearance we performed a randomized phase 2 study in 90 patients (45 per arm) with aggressive HIV-NHLs using dose-adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle. Up to 1 prior cycle of systemic chemotherapy was allowed. The primary endpoint was complete response (CR). In 86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1), CR rates were 74% versus 68% for EPOCH versus EPOCH-vorinostat, respectively (1-sided P=0.72). Patients with CD4+ count <200 cells/mm3 had a lower CR rate. EPOCH-vorinostat did not eliminate HIV reservoirs and resulted in more frequent grade 4 neutropenia and thrombocytopenia (47% and 29%, respectively) versus EPOCH (20% and 2%, respectively). The overall and event-free survival (EFS) rates were similar between arms. Overall, patients with Myc+ DLBCL had significantly lower EFS (44% at 3-yr, versus 83% in Myc- DLBCL). Low diagnosis-to-treatment interval (DTI) was also associated with inferior outcomes, while pre-protocol therapy had no negative impact. In conclusion, EPOCH had broad efficacy against highly aggressive HIV-NHLs, while vorinostat had no benefit; patients with Myc-driven DLBCL, low CD4, and low DTI had less favorable outcomes. Permitting pre-protocol therapy facilitated accruals without compromising outcomes. NCT0119384.",2020,The overall and event-free survival (EFS) rates were similar between arms.,"['86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1', '90 patients (45 per arm) with aggressive HIV-NHLs using dose']",['adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle'],"['CR rates', 'EPOCH efficacy', 'complete response (CR', 'Low diagnosis-to-treatment interval (DTI', 'EFS', 'overall and event-free survival (EFS) rates', 'and/or HIV clearance', 'frequent grade 4 neutropenia and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0079746', 'cui_str': ""Diffuse non-Hodgkin's lymphoma, immunoblastic (clinical)""}, {'cui': 'C1292753', 'cui_str': 'Primary effusion lymphoma'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",90.0,0.175059,The overall and event-free survival (EFS) rates were similar between arms.,"[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Weill Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Reid', 'Affiliation': 'Moores UCSD Cancer Center, La Jolla, California, United States.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Siegel', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States.'}, {'ForeName': 'Page C', 'Initials': 'PC', 'LastName': 'Moore', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Rubinstein', 'Affiliation': 'John H. Stroger Hospital of Cook County, Chicago, Illinois, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Durand', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Cesarman', 'Affiliation': 'Weill Cornell Medicine, New York, New York, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Aboulafia', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Baiocchi', 'Affiliation': 'Ohio State University, Colmubus, Ohio, United States.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ratner', 'Affiliation': 'Washington University, St. Louis, Missouri, United States.'}, {'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'University of California, San Francisco, San Francisco, California, United States.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Capoferri', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'U. of Arkansas for Medical Sciences, :Little Rock, Arkansas, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'UCLA, Los Angeles, California, United States.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Noy', 'Affiliation': 'Weill Cornell Medicine, United States.'}]",Blood,['10.1182/blood.2019003959']
1440,32431211,Accurately Reflecting Uncertainty When Using Patient-Level Simulation Models to Extrapolate Clinical Trial Data.,"Introduction.  Patient-level simulation models facilitate extrapolation of clinical trial data while allowing for heterogeneity, prior history, and nonlinearity. However, combining different types of uncertainty around within-trial and extrapolated results remains challenging.  Methods.  We tested 4 methods to combine parameter uncertainty (around the regression coefficients used to predict future events) with sampling uncertainty (uncertainty around mean risk factors within the finite sample whose outcomes are being predicted and the effect of treatment on these risk factors). We compared these 4 methods using a simulation study based on an economic evaluation extrapolating the AFORRD randomized controlled trial using the UK Prospective Diabetes Study Outcomes Model version 2. This established type 2 diabetes model predicts patient-level health outcomes and costs.  Results.  The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value). Allowing for sampling uncertainty as well as parameter uncertainty widened confidence intervals by 6.3-fold and gave 96.3% coverage. Methods adjusting for baseline risk factors that combine sampling and parameter uncertainty overcame the bias that can result from between-group baseline imbalance and gave confidence intervals around 50% wider than those just considering parameter uncertainty, with 99.8% coverage.  Conclusions.  Analyses extrapolating data for individual trial participants should include both sampling uncertainty and parameter uncertainty and should adjust for any imbalance in baseline covariates.",2020,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).",[],[],[],[],[],[],,0.0800414,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).","[{'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research & Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20916442']
1441,31937553,"Impact of respiratory muscle training on respiratory muscle strength, respiratory function and quality of life in individuals with tetraplegia: a randomised clinical trial.","BACKGROUND


Respiratory complications remain a leading cause of morbidity and mortality in people with acute and chronic tetraplegia. Respiratory muscle weakness following spinal cord injury-induced tetraplegia impairs lung function and the ability to cough. In particular, inspiratory muscle strength has been identified as the best predictor of the likelihood of developing pneumonia in individuals with tetraplegia. We hypothesised that 6 weeks of progressive respiratory muscle training (RMT) increases respiratory muscle strength with improvements in lung function, quality of life and respiratory health.
METHODS


Sixty-two adults with tetraplegia participated in a double-blind randomised controlled trial. Active or sham RMT was performed twice daily for 6 weeks. Inspiratory muscle strength, measured as maximal inspiratory pressure (PImax) was the primary outcome. Secondary outcomes included lung function, quality of life and respiratory health. Between-group comparisons were obtained with linear models adjusting for baseline values of the outcomes.
RESULTS


After 6 weeks, there was a greater improvement in PImax in the active group than in the sham group (mean difference 11.5 cmH 2 O (95% CI 5.6 to 17.4), p<0.001) and respiratory symptoms were reduced (St George Respiratory Questionnaire mean difference 10.3 points (0.01-20.65), p=0.046). Significant improvements were observed in quality of life (EuroQol-Five Dimensional Visual Analogue Scale 14.9 points (1.9-27.9), p=0.023) and perceived breathlessness (Borg score 0.64 (0.11-1.17), p=0.021). There were no significant improvements in other measures of respiratory function (p=0.126-0.979).
CONCLUSIONS


Progressive RMT increases inspiratory muscle strength in people with tetraplegia, by a magnitude which is likely to be clinically significant. Measurement of baseline PImax and provision of RMT to at-risk individuals may reduce respiratory complications after tetraplegia.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN 12612000929808).",2020,"There were no significant improvements in other measures of respiratory function (p=0.126-0.979).
","['Sixty-two adults with tetraplegia participated', 'individuals with tetraplegia', 'people with acute and chronic tetraplegia', 'people with tetraplegia']","['spinal cord injury-induced tetraplegia', 'progressive respiratory muscle training (RMT', 'respiratory muscle training', 'Active or sham RMT']","['respiratory symptoms', 'lung function, quality of life and respiratory health', 'Inspiratory muscle strength', 'respiratory muscle strength, respiratory function and quality of life', 'perceived breathlessness', 'maximal inspiratory pressure (PImax', 'inspiratory muscle strength', 'improvement in PImax', 'respiratory function', 'quality of life (EuroQol-Five Dimensional Visual Analogue Scale']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",62.0,0.362344,"There were no significant improvements in other measures of respiratory function (p=0.126-0.979).
","[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia c.boswell-ruys@neura.edu.au.'}, {'ForeName': 'Chaminda R H', 'Initials': 'CRH', 'LastName': 'Lewis', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nirupama S', 'Initials': 'NS', 'LastName': 'Wijeysuriya', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'McBain', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bonsan Bonne', 'Initials': 'BB', 'LastName': 'Lee', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'McKenzie', 'Affiliation': 'Prince of Wales Hospital and Community Health Services, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Gandevia', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Butler', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}]",Thorax,['10.1136/thoraxjnl-2019-213917']
1442,32431275,Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial.,"A cluster-randomized, double-blinded, placebo-controlled trial was conducted to estimate the protective efficacy (PE) of a spatial repellent (SR) against malaria infection in Sumba, Indonesia. Following radical cure in 1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given transfluthrin or placebo passive emanators (devices designed to release vaporized chemical). Monthly blood screening and biweekly human-landing mosquito catches were performed during a 10-month baseline (June 2015-March 2016) and a 24-month intervention period (April 2016-April 2018). Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households. The 24-cluster protective effect of 27.7% and 31.3%, for time to first-event and overall (total new) infections, respectively, was not statistically significant. Purportedly, this was due in part to zero to low incidence in some clusters, undermining the ability to detect a protective effect. Subgroup analysis of 19 clusters where at least one infection occurred during baseline showed 33.3% ( P -value = 0.083) and 40.9% ( P -value = 0.0236, statistically significant at the one-sided 5% significance level) protective effect to first infection and overall infections, respectively. Among 12 moderate- to high-risk clusters, a statistically significant decrease in infection by intervention was detected (60% PE). Primary entomological analysis of impact was inconclusive. Although this study suggests SRs prevent malaria, additional evidence is required to demonstrate the product class provides an operationally feasible and effective means of reducing malaria transmission.",2020,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","['Control of Malaria in Indonesia', '1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given', '667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households']","['transfluthrin or placebo passive emanators (devices designed to release vaporized chemical', 'Monthly blood screening and biweekly human-landing mosquito catches', 'placebo']","['infection by intervention', 'protective efficacy (PE', '24-cluster protective effect', 'time to first-event and overall (total new) infections']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3178479', 'cui_str': 'transfluthrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086137', 'cui_str': 'Device Design'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205314', 'cui_str': 'New'}]",1341.0,0.277179,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","[{'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Puji B S', 'Initials': 'PBS', 'LastName': 'Asih', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Ismail Ekoprayitno', 'Initials': 'IE', 'LastName': 'Rozi', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Dendi Hadi', 'Initials': 'DH', 'LastName': 'Permana', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Anggi Puspa', 'Initials': 'AP', 'LastName': 'Nur Hidayati', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Lepa', 'Initials': 'L', 'LastName': 'Syahrani', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Zubaidah', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Sidik', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bangs', 'Affiliation': 'Public Health and Malaria Control, PT Freeport Indonesia, International SOS, Kuala Kencana, Papua, Indonesia.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bøgh', 'Affiliation': 'The Sumba Foundation, Public Health and Malaria Control, Bali, Indonesia.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Applied and Computational Mathematics and Statistics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Evercita C', 'Initials': 'EC', 'LastName': 'Eugenio', 'Affiliation': 'Department of Applied and Computational Mathematics and Statistics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Hendrickson', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'J Kevin', 'Initials': 'JK', 'LastName': 'Baird', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Collins', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Grieco', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Neil F', 'Initials': 'NF', 'LastName': 'Lobo', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Achee', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0554']
1443,19459475,"[Clinical trial of new inactivated influenza vaccine ""Grifor""].","AIM


To confirm and prove on the extended contingent of volunteers the non-reactogenicity, safety and immunogenicity of ""Grifor"" vaccine in comparative trial with registered in Russia commercial vaccine ""Vaxigrip"".
MATERIALS AND METHODS


Phase II clinical trial was performed on the research bases of Mechnikov Institute of Vaccines and Sera and Institute of Influenza. In single-blind comparative prospective randomized trial 300 adult volunteers (150 volunteers on each base) aged 18 - 60 y.o. were divided on 3 equivalent groups. Assessment of antigenic characteristics of ""Grifor"" vaccine was performed using hemagglutination inhibition assay (HAI) with chicken erythrocytes measuring geometric mean titer (GMT), seroconversion factor as well as level of seroconversion and seroprotection.
RESULTS


Previously performed studies proved non-reactogenicity, safety and high immunogenicity of ""Grifor"", whereas this comparative trial performed with commercial vaccine ""Vaxigrip"" did not reveal significant advantage in any of studied vaccine.
CONCLUSION


""Grifor"" vaccine meet the requirements of both EMEA CPMP and methodic guidelines MY 3.3.2. 1758-03 for inactivated influenza vaccines, which allows to register vaccine ""Grifor"" in Russian Federation.",2009,"Assessment of antigenic characteristics of ""Grifor"" vaccine was performed using hemagglutination inhibition assay (HAI) with chicken erythrocytes measuring geometric mean titer (GMT), seroconversion factor as well as level of seroconversion and seroprotection.
","['Phase II clinical trial was performed on the research bases of Mechnikov Institute of Vaccines and Sera and Institute of Influenza', '300 adult volunteers (150 volunteers on each base) aged 18 - 60 y.o']","['new inactivated influenza vaccine ""Grifor']","['geometric mean titer (GMT), seroconversion factor as well as level of seroconversion and seroprotection']","[{'cui': 'C1096779', 'cui_str': 'Clinical Trial, Phase 2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035168'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C2715804', 'cui_str': 'Grifor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",300.0,0.0290749,"Assessment of antigenic characteristics of ""Grifor"" vaccine was performed using hemagglutination inhibition assay (HAI) with chicken erythrocytes measuring geometric mean titer (GMT), seroconversion factor as well as level of seroconversion and seroprotection.
","[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Zverev', 'Affiliation': ''}, {'ForeName': 'O I', 'Initials': 'OI', 'LastName': 'Kiselev', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Korovkin', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Mironov', 'Affiliation': ''}, {'ForeName': 'S Ia', 'Initials': 'SIa', 'LastName': ""Mel'nikov"", 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Mikhaĭlova', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kostinov', 'Affiliation': ''}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Erofeeva', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Solomina', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Dyldina', 'Affiliation': ''}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Zhirova', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Stukova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1444,31618132,Clinicogenomic Radiotherapy Classifier Predicting the Need for Intensified Locoregional Treatment After Breast-Conserving Surgery for Early-Stage Breast Cancer.,"PURPOSE


Most patients with early-stage breast cancer are treated with adjuvant radiotherapy (RT) after breast-conserving surgery (BCS) to prevent locoregional recurrence (LRR). However, no genomic tools are used currently to select the optimal RT strategy.
METHODS


We profiled the transcriptome of primary tumors on a clinical grade assay from the SweBCG91-RT trial, in which patients with node-negative breast cancer were randomly assigned to either whole-breast RT after BCS or no RT. We derived a new classifier, Adjuvant Radiotherapy Intensification Classifier (ARTIC), comprising 27 genes and patient age, in three publicly available cohorts, then independently validated ARTIC for LRR in 748 patients in SweBCG91-RT. We also compared previously published genomic signatures for ability to predict benefit from RT in SweBCG91-RT.
RESULTS


ARTIC was highly prognostic for LRR in patients treated with RT (hazard ratio [HR], 3.4; 95% CI, 2.0 to 5.9;  P  < .001) and predictive of RT benefit ( P interaction  = .005). Patients with low ARTIC scores had a large benefit from RT (HR, 0.33 [95% CI, 0.21 to 0.52],  P  < .001; 10-year cumulative incidence of LRR, 6%  v  21%), whereas those with high ARTIC scores benefited less from RT (HR, 0.73 [95% CI, 0.44 to 1.2],  P  = .23; 10-year cumulative incidence of LRR, 25%  v  32%). In contrast, none of the eight previously published signatures were predictive of benefit from RT in SweBCG91-RT.
CONCLUSION


ARTIC identified women with a substantial benefit from RT as well as women with a particularly elevated LRR risk in whom whole-breast RT was not sufficiently effective and, thus, in whom intensified treatment strategies such as tumor-bed boost, and possibly regional nodal RT, should be considered. To our knowledge, ARTIC is the first classifier validated as predictive of benefit from RT in a phase III clinical trial with patients randomly assigned to receive or not receive RT.",2019,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","['patients with node-negative breast cancer', 'Early-Stage Breast Cancer', '748 patients in SweBCG91-RT', 'patients with early-stage breast cancer']","['whole-breast RT after BCS or no RT', 'adjuvant radiotherapy (RT) after breast-conserving surgery (BCS', 'Clinicogenomic Radiotherapy Classifier']",['predictive of RT benefit'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],748.0,0.0539045,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'S Laura', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'PFS Genomics, Vancouver, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Fishbane', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Shuang G', 'Initials': 'SG', 'LastName': 'Zhao', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hartman', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Speers', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00761']
1445,32430693,"A multi-camera, multi-view system for training and skill assessment for robot-assisted surgery.","PURPOSE


This paper introduces the concept of using an additional intracorporeal camera for the specific goal of training and skill assessment and explores the benefits of such an approach. This additional camera can provide an additional view of the surgical scene, and we hypothesize that this additional view would improve surgical training and skill assessment in robot-assisted surgery.
METHODS


We developed a multi-camera, multi-view system, and we conducted two user studies ([Formula: see text]) to evaluate its effectiveness for training and skill assessment. In the training user study, subjects were divided into two groups: a single-view group and a dual-view group. The skill assessment study was a within-subject study, in which every subject was shown single- and dual view recorded videos of a surgical training task, and the goal was to count the number of errors committed in each video.
RESULTS


The results show the effectiveness of using an additional intracorporeal camera view for training and skill assessment. The benefits of this view are modest for skill assessment as it improves the assessment accuracy by approximately 9%. For training, the additional camera view is clearly more effective. Indeed, the dual-view group is 57% more accurate than the single-view group in a retention test. In addition, the dual-view group is 35% more accurate and 25% faster than the single-view group in a transfer test.
CONCLUSION


A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery. One application of our work is to include an additional camera view in existing virtual reality surgical training simulators to realize its benefits in training. The views from the additional intracorporeal camera can also be used to improve on existing surgical skill assessment criteria used in training systems for robot-assisted surgery.",2020,"A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery.",[],['single-view group and a dual-view group'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",[],,0.0292817,"A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery.","[{'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Abdelaal', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada. aabdelaal@ece.ubc.ca.'}, {'ForeName': 'Apeksha', 'Initials': 'A', 'LastName': 'Avinash', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Kalia', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Hager', 'Affiliation': 'Department of Computer Science, Johns Hopkins University, Baltimore, MD, 21218, USA.'}, {'ForeName': 'Septimiu E', 'Initials': 'SE', 'LastName': 'Salcudean', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-020-02176-1']
1446,32432487,Which Mothers Know That All Babies Cry? A Randomized Controlled Trial of a Child Abuse Prevention Program for Low-Income New Mothers.,"This study evaluated an intervention for low-income new mothers, half from Spanish-speaking homes, that provides education around infant crying and abusive head trauma (AHT). At enrollment, non-US-born mothers were less likely than US-born mothers to have heard of shaken baby syndrome (60% vs 89%,  P  ≤ .0001) or to know shaking babies could lead to brain damage or death (48% vs 80%,  P  < .0001). At follow-up, non-US-born intervention mothers had improved knowledge of the peak of crying (31% vs 4%,  P  = .009), improved knowledge that shaking a baby could lead to brain damage or death (36% vs 12%,  P  = .035), and identified more calming strategies for parenting stress compared with non-US-born control mothers (+0.8 [SD = 1.1] vs -0.4 [SD = 1.4]). This study identifies a gap in AHT knowledge at baseline of non-US-born mothers. These mothers had improved knowledge with intervention and are an important population for similar prevention efforts.",2020,"At enrollment, non-US-born mothers were less likely than US-born mothers to have heard of shaken baby syndrome (60% vs 89%,  P  ≤ .0001) or to know shaking babies could lead to brain damage or death (48% vs 80%,  P  < .0001).","['Low-Income New Mothers', 'non-US-born mothers', 'low-income new mothers, half from Spanish-speaking homes, that provides education around infant crying and abusive head trauma (AHT']",['Child Abuse Prevention Program'],"['brain damage or death', 'heard of shaken baby syndrome', 'knowledge of the peak of crying']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}]","[{'cui': 'C1261559', 'cui_str': 'Child abuse prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0686721', 'cui_str': 'Shaken baby syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010399', 'cui_str': 'Crying'}]",,0.0492089,"At enrollment, non-US-born mothers were less likely than US-born mothers to have heard of shaken baby syndrome (60% vs 89%,  P  ≤ .0001) or to know shaking babies could lead to brain damage or death (48% vs 80%,  P  < .0001).","[{'ForeName': 'Luisa F', 'Initials': 'LF', 'LastName': 'Cala Cala', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Carrie Leah', 'Initials': 'CL', 'LastName': 'Kelly', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Elaina', 'Initials': 'E', 'LastName': 'Ramos', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'VanVleet', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'High', 'Affiliation': 'Brown University, Providence, RI, USA.'}]",Clinical pediatrics,['10.1177/0009922820922532']
1447,31692233,Coherence principles in interval-based dose finding.,"This paper studies the notion of coherence in interval-based dose-finding methods. An incoherent decision is either (a) a recommendation to escalate the dose following an observed dose-limiting toxicity or (b) a recommendation to deescalate the dose following a non-dose-limiting toxicity. In a simulated example, we illustrate that the Bayesian optimal interval method and the Keyboard method are not coherent. We generated dose-limiting toxicity outcomes under an assumed set of true probabilities for a trial of n=36 patients in cohorts of size 1, and we counted the number of incoherent dosing decisions that were made throughout this simulated trial. Each of the methods studied resulted in 13/36 (36%) incoherent decisions in the simulated trial. Additionally, for two different target dose-limiting toxicity rates, 20% and 30%, and a sample size of n=30 patients, we randomly generated 100 dose-toxicity curves and tabulated the number of incoherent decisions made by each method in 1000 simulated trials under each curve. For each method studied, the probability of incurring at least one incoherent decision during the conduct of a single trial is greater than 75%. Coherency is an important principle in the conduct of dose-finding trials. Interval-based methods violate this principle for cohorts of size 1 and require additional modifications to overcome this shortcoming. Researchers need to take a closer look at the dose assignment behavior of interval-based methods when using them to plan dose-finding studies.",2020,Researchers need to take a closer look at the dose assignment behavior of interval-based methods when using them to plan dose-finding studies.,['n=36 patients in cohorts of size 1'],[],['toxicity rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",[],"[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",1000.0,0.14379,Researchers need to take a closer look at the dose assignment behavior of interval-based methods when using them to plan dose-finding studies.,"[{'ForeName': 'Nolan A', 'Initials': 'NA', 'LastName': 'Wages', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Iasonos', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Quigley"", 'Affiliation': 'LPSM, INSERM, Sorbonne University, Paris, France.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}]",Pharmaceutical statistics,['10.1002/pst.1974']
1448,31397488,Efficacy and safety of telbivudine to prevent mother-to-child transmission of hepatitis B virus in middle- and late-stage pregnancy with high viral loads.,"OBJECTIVE


To observe the efficacy and safety of telbivudine on mother-infant blockade in pregnant women with hepatitis B virus (HBV) DNA.
METHODS


A total of 141 pregnant women between 24 and 28 weeks of gestation and chronic HBV carriers with HBV DNA ≥10 6   copies/mL were enrolled, 105 in the treatment group and 36 in the control group. The treatment group was given telbivudine 600 mg/d oral, and the control group did not use antiviral drugs. Hepatitis B immunoglobulin 200 IU intramuscular injection and hepatitis B vaccine (HBVac) 10 μg subcutaneous injection were given to the infants in both groups within 12 hours after birth, and 10 μg of HBVac was subcutaneously injected when the infants were 1-month and 6-month old. Safety endpoints including HBV DNA quantification, liver function, CK were observed before treatment, 4 weeks after treatment, before delivery, and 24 weeks after delivery.
RESULTS


There was no difference in HBV DNA levels between the two groups before treatment and 6 months after delivery (P > .05). The HBV DNA level in the treatment group was significantly lower than that in the control group before delivery (P < .05). Between the two groups, the HBV positive rate was statistically different between the two groups (P < .05), and the difference of serum HBsAg of infants had statistical significance (P < .05), but the safety of the telbivudine group was not significantly different from that of the control group (P > .05).
CONCLUSION


The application of telbivudine antiviral therapy in the middle and late stage of pregnancy of HBV high-load pregnant women can significantly reduce the HBV DNA level before delivery, reduce the mother-to-child transmission rate of HBV, and have excellent security.",2019,There was no difference in HBV DNA levels between the two groups before treatment and 6 months after delivery (P > .05).,"['middle and late stage of pregnancy of HBV high-load pregnant women', 'pregnant women with hepatitis B virus (HBV) DNA', 'mother-to-child transmission of hepatitis B virus in middle- and late-stage pregnancy with high viral loads', '141 pregnant women between 24 and 28 weeks of gestation and chronic HBV carriers with HBV DNA ≥10 6  \u2009copies/mL were enrolled, 105 in the treatment group and 36 in the control group']","['telbivudine', 'telbivudine antiviral therapy', 'telbivudine 600\u2009mg/d oral, and the control group did not use antiviral drugs', 'Hepatitis B immunoglobulin 200\u2009IU intramuscular injection and hepatitis B vaccine (HBVac']","['serum HBsAg', 'HBV DNA quantification, liver function, CK', 'HBV DNA level', 'Efficacy and safety', 'efficacy and safety', 'HBV positive rate', 'HBV DNA levels']","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0282474', 'cui_str': 'Mother-to-Child Transmission'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1453933', 'cui_str': 'telbivudine'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C1813935', 'cui_str': 'telbivudine 600 MG'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C0062525', 'cui_str': 'hepatitis B immunoglobin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",141.0,0.0420657,There was no difference in HBV DNA levels between the two groups before treatment and 6 months after delivery (P > .05).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China.'}, {'ForeName': 'Lin Lin', 'Initials': 'LL', 'LastName': 'Tao', 'Affiliation': 'Division of Infectious Diseases, Department of Infectious Diseases, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230000, China.'}, {'ForeName': 'Li Xian', 'Initials': 'LX', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University,Jinan, Jinan, Shandong, 250012, China.'}]",Journal of medical virology,['10.1002/jmv.25566']
1449,31866194,The impact of residents sitting at the bedside on patient satisfaction during team rounds.,"OBJECTIVES


Patient satisfaction ratings are a priority for academic medical centers. Sitting during patient encounters has been recommended as a ""best practice."" 1  A prior study showed that hospitalists had higher-rated communication skills when sitting compared to standing at the bedside during rounds. 2  It is unclear whether the same is true of resident-led team rounds.
METHODS


We performed a cluster-randomized crossover trial assigning 18 internal medicine residents to sit or stand at the bedside during rounds.
RESULTS


A total of 347 patients were surveyed to assess physician communication skills. Standing residents received higher ratings than sitting residents on 2 of 5 survey items and rounding duration did not differ. These results differ from prior work that suggests sitting is superior to standing 2-6 .
CONCLUSION


We suspect that one rounding member sitting, while all others stand, is not enough to impact patients' perceptions. These results suggest that initiatives to optimize patient satisfaction on resident-staffed units should be focused elsewhere.
PRACTICE IMPLICATIONS


Patients do not have better impressions of physician communication skills when one team member is sitting and the rest are standing.",2020,Standing residents received higher ratings than sitting residents on 2 of 5 survey items and rounding duration did not differ.,"['347 patients were surveyed to assess physician communication skills', '18 internal medicine residents to sit or stand at the bedside during rounds']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",[],[],347.0,0.0382242,Standing residents received higher ratings than sitting residents on 2 of 5 survey items and rounding duration did not differ.,"[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Donovan', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: donovanak2@upmc.edu.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Spagnoletti', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rothenberger', 'Affiliation': 'Institute for Clinical Research Education, Center for Research on Healthcare Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Corbelli', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Patient education and counseling,['10.1016/j.pec.2019.12.013']
1450,31904784,Clinical Significance and Outcomes in Trial of Nabiximols for Treatment of Cannabis Dependence.,,2020,,['Cannabis Dependence'],[],[],"[{'cui': 'C0006870', 'cui_str': 'Cannabis Dependence'}]",[],[],,0.0573766,,"[{'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5664']
1451,31904790,Clinical Significance and Outcomes in Trial of Nabiximols for Treatment of Cannabis Dependence-Reply.,,2020,,[],[],[],[],[],[],,0.0535297,,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5670']
1452,31904785,Clinical Significance and Outcomes in Trial of Nabiximols for Treatment of Cannabis Dependence.,,2020,,['Cannabis Dependence'],[],[],"[{'cui': 'C0006870', 'cui_str': 'Cannabis Dependence'}]",[],[],,0.0573766,,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Kleinman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5667']
1453,31553693,"High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008.","PURPOSE


The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases.
METHODS


From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and  P  value were corrected for the three previous interim analyses by the inverse normal method.
RESULTS


Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10;  P  = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44;  P  = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm.
CONCLUSION


In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.",2019,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10;  P  = .16).","['Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases', 'From 2000 to 2015, we enrolled patients older than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases', 'Ewing Sarcoma', 'Selected patients requiring radiotherapy to an axial primary site', 'Of 543 potentially eligible patients']","['standard chemotherapy with WLI', 'busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI', 'Standard Chemotherapy and Lung Radiation', 'radiotherapy and busulfan', 'chemotherapy', 'High-Dose Chemotherapy', 'BuMel', 'vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI', 'VAI plus WLI']","['severe acute toxicities', 'Event-free survival', 'survival outcomes', 'overall survival', 'hazard ratio (HR']","[{'cui': 'C0553580', 'cui_str': ""Ewing's Tumor""}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0153678', 'cui_str': 'Secondary malignant neoplasm of pleura (disorder)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",287.0,0.239424,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10;  P  = .16).","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Dirksen', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Centre Oscar Lambret, Lille; and Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Cozic', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van den Berg', 'Affiliation': 'Emma Children Hospital - Amsterdam University Medical Centres, Amsterdam, the Netherlands.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bhadri', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Brichard', 'Affiliation': 'Cliniques Universitaires Saint Luc, Brussels, Belgium.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Claude', 'Affiliation': 'Centre Léon Bérard, Lyon; France.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Craft', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Amler', 'Affiliation': 'Westfalian Wilhelms University Muenster, Muenster; and Friedrich- Loeffler Institute, Greifswald-Insel Riems, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gorlick', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Holcombe E', 'Initials': 'HE', 'LastName': 'Grier', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guinbretiere', 'Affiliation': 'Hôpital René-Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hauser', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hjorth', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Janeway', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Juergens', 'Affiliation': 'Universitaetskinderklinik Muenster, Muenster, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'Royal Marsden Foundation NHS Trust, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Krailo', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jarmila', 'Initials': 'J', 'LastName': 'Kruseova', 'Affiliation': 'Charles University Prague, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuehne', 'Affiliation': ""University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Lervat', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Lewis', 'Affiliation': 'University of Leeds, Liverpool, United Kingdom.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Linassier', 'Affiliation': 'Centre Hospitalier Universitaire, Tours, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Marec-Berard', 'Affiliation': 'Institute of Pediatric Onco-Haematology, Lyon, France.'}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'Five Time Therapeutics, South San Francisco, CA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women and Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pacquement', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paulussen', 'Affiliation': 'Witten/Herdecke University, Datteln, Germany.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'University of California Davis, Sacramento, CA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ranft', 'Affiliation': 'Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Le Teuff', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Womer', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Oberlin', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00915']
1454,18283734,[Clinical immunological effect of interferon in cases of influenza].,"New drug formulation--a sublingual tablet--was developed on the basis of human leukocyte interferon (HLI). Evaluation of antiviral and immunomodulatory effects of the new formulation of HLI in patients with influenza showed its efficacy. The drug shortened duration of intoxication and catarrhal syndrome, decreased rate of complications and restored interferon status. Obtained results showed that ""Interferon tablets 4000 IU"" can be used in complex treatment of patients with influenza.",2007,"The drug shortened duration of intoxication and catarrhal syndrome, decreased rate of complications and restored interferon status.","['cases of influenza', 'patients with influenza']",['interferon'],"['rate of complications and restored interferon status', 'duration of intoxication and catarrhal syndrome']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",,0.0169056,"The drug shortened duration of intoxication and catarrhal syndrome, decreased rate of complications and restored interferon status.","[{'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Volkova', 'Affiliation': ''}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': ""Vorob'eva"", 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Bondarenko', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': ""Sedel'nikova"", 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Okishev', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1455,31358436,Methylphenidate and atomoxetine normalise fronto-parietal underactivation during sustained attention in ADHD adolescents.,"Problems with sustained attention are a key clinical feature of Attention Deficit/Hyperactivity Disorder (ADHD) which also manifests in poor performance and abnormal fronto-striato-parietal activation during sustained attention. Methylphenidate and atomoxetine improve attention functions and upregulate abnormal fronto-cortical activation during executive function tasks in ADHD patients. Despite this, no functional Magnetic Resonance Imaging (fMRI) study has compared the effects of methylphenidate and atomoxetine on the neurofunctional substrates of sustained attention in ADHD. This randomised, double-blind, placebo-controlled, cross-over study investigated the comparative normalisation effects of methylphenidate and atomoxetine on fMRI correlates and performance in 14 ADHD adolescents relative to 27 age-matched healthy controls during a parametric sustained attention/vigilance task with progressively increasing load of sustained attention. ADHD patients were scanned three times under a single clinical dose of either methylphenidate, atomoxetine, or placebo in pseudo-randomised order. Healthy controls were scanned once and compared to patients under each drug condition to test for potential drug-normalisation effects. Relative to controls, ADHD boys under placebo were impaired in performance and had underactivation in predominantly right-hemispheric fronto-parietal, and striato-thalamic regions. Both drugs normalised all underactivations, while only methylphenidate improved performance deficits. Within patients, methylphenidate had a drug-specific effect of upregulating left ventrolateral prefrontal/superior temporal activation relative to placebo and atomoxetine, while both drugs increased activation of right middle/superior temporal cortex, posterior cingulate, and precuneus relative to placebo. The study shows shared normalisation effects of methylphenidate and atomoxetine on fronto-striato-thalamo-parietal dysfunction in ADHD during sustained attention but a drug-specific upregulation effects of methylphenidate on ventral fronto-temporal regions.",2019,"Relative to controls, ADHD boys under placebo were impaired in performance and had underactivation in predominantly right-hemispheric fronto-parietal, and striato-thalamic regions.","['ADHD adolescents', '14 ADHD adolescents relative to 27 age-matched healthy controls during a parametric sustained attention/vigilance task with progressively increasing load of sustained attention', 'ADHD patients']","['Methylphenidate and atomoxetine', 'placebo and atomoxetine', 'placebo', 'methylphenidate, atomoxetine, or placebo', 'methylphenidate and atomoxetine', 'methylphenidate']","['fMRI correlates and performance', 'performance deficits']","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}]",,0.258623,"Relative to controls, ADHD boys under placebo were impaired in performance and had underactivation in predominantly right-hemispheric fronto-parietal, and striato-thalamic regions.","[{'ForeName': 'Olivia S', 'Initials': 'OS', 'LastName': 'Kowalczyk', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK. Electronic address: olivia.kowalczyk@kcl.ac.uk.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Cubillo', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK; Jacobs Center for Productive Youth Development, Zurich Center for Neuroeconomics, University of Zürich, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Barrett', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brammer', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, UK; Centre for Neurodegeneration Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK; NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Trust and Institute of Psychiatry, Psychology & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Rubia', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.07.139']
1456,32432795,"The effect of mindfulness-based training on stress, anxiety, depression and job satisfaction among ward nurses: A randomized control trial.","AIM


To assess the effect of a 4-week mindfulness-based training intervention on improving stress, anxiety, depression and job satisfaction among ward nurses.
BACKGROUND


Previous literature showed that mindfulness-based training is useful for helping nurses cope with stress.
METHOD


Nurses who have mild to moderate levels of stress, anxiety and depression identified from a teaching hospital were invited to a randomized control trial. The intervention group had a 2-hr Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website. Both the intervention group (n = 118) and the control group (n = 106) were evaluated pre- and post-intervention, and 8 weeks later (follow-up) using the Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale and Mindful Attention Awareness Scale.
RESULTS


There was a significant effect over time on stress, anxiety, depression and mindfulness level (p < .05). Regarding the difference between the groups and interaction between time and group, there was a significant effect for anxiety (p = .037 p = .008) and job satisfaction (p < .001, p = .40), respectively, with moderate effect size for anxiety reduction (.465) and small for job satisfaction increment (.221).
CONCLUSION


Mindfulness-Based Training is effective in improving anxiety and job satisfaction among nurses.
CLINICAL IMPLICATIONS FOR NURSING MANAGEMENT


Mindfulness-Based Training can be included as hospital policy to reduce anxiety and increase job satisfaction among nurses.",2020,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","['Nurses who have mild to moderate levels of stress, anxiety, and depression identified from a teaching hospital', 'Among Ward Nurses']","['Mindfulness-Based Training', '4-week Mindfulness-Based Training intervention', '2-hour Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website', 'mindfulness training']","['stress, anxiety, depression and mindful level (p˂.05', 'anxiety', 'anxiety and job satisfaction', 'Stress, Anxiety, Depression, and Job Satisfaction', 'anxiety reduction', 'Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale, and Mindful Attention Awareness Scale', 'job satisfaction', 'stress, anxiety, depression, and job satisfaction']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0175315,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","[{'ForeName': 'Sajed Faisal', 'Initials': 'SF', 'LastName': 'Ghawadra', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Khatijah', 'Initials': 'K', 'LastName': 'Lim Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan Yuen', 'Initials': 'WY', 'LastName': 'Choo', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Danaee', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Cheng Kar', 'Initials': 'CK', 'LastName': 'Phang', 'Affiliation': 'Behavioral Health Centre, Sunway Medical Centre, Selangor, Malaysia.'}]",Journal of nursing management,['10.1111/jonm.13049']
1457,31988029,Effect of an upstream grid on the fluidization of pharmaceutical carrier powders.,"The influence of grid generated mixing on the fluidization of pharmaceutical carrier powders is studied in a channel-flow experiment using direct high-speed imaging and particle image velocimetry (PIV). Four different lactose powders with mass median diameters that range between 61 µm and 121 µm are used. The degree of powder mixing in the flow as a function of grid position relative to the powder bed and grid area blockage ratios (ranging from ~25% to ~40%) is studied for a range of flow-rates. The study presents comprehensive mappings of how pharmaceutical powders are fluidised under the influence of mixing, by examining powder bed morphology, powder emptying rate, and the local flow-field surrounding the pocket. The use of a grid results in higher evacuation percentages (void fraction) and a faster evacuation rate but is associated with randomized evacuation behaviour as observed from the powder bed morphology. Use of a grid can enable evacuation of powder at lower overall flow-rates, which may have important implications on respiratory drug delivery. PIV results show the trend of mean velocities with the mass median powder diameter and demonstrates how a grid with lower blockage ratio can increase the degree of mixing of the evacuating powder and make the evacuation process more rapid. This study contributes towards a better understanding of fluidization processes as relevant to dry powder inhaler devices and sheds light on how simple design alterations, such as adding an upstream grid, can be incorporated to optimise device effectiveness.",2020,The use of a grid results in higher evacuation percentages (void fraction) and a faster evacuation rate but is associated with randomized evacuation behaviour as observed from the powder bed morphology.,[],[],[],[],[],[],,0.0304694,The use of a grid results in higher evacuation percentages (void fraction) and a faster evacuation rate but is associated with randomized evacuation behaviour as observed from the powder bed morphology.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Elserfy', 'Affiliation': 'School of Engineering, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kourmatzis', 'Affiliation': 'School of Aerospace, Mechanical and Mechatronic Engineering, The University of Sydney, NSW 2006, Australia. Electronic address: agisilaos.kourmatzis@sydney.edu.au.'}, {'ForeName': 'H-K', 'Initials': 'HK', 'LastName': 'Chan', 'Affiliation': 'Advanced Drug Delivery Group, School of Pharmacy, The University of Sydney, NSW 2006, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Walenga', 'Affiliation': 'Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'School of Engineering, Macquarie University, NSW 2109, Australia.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119079']
1458,18038549,[Analysis of cytokines in seminal plasma and blood sera of patients with chronic prostatitis during immunotherapy with natural complex of cytokines and antimicrobial peptides].,"Levels of pro- and anti-inflammatory cytokines (TNFalpha, IL-6, IL-8, IL-10) were studied in blood sera and seminal plasma of healthy volunteers and patients with chronic bacterial prostatitis (CBP) or chronic abacterial prostatitis (CABP). Assessment of effect of immunotropic drug Superlymph with direct antimicrobial action for treatment of mentioned groups of patients was performed. It was shown that seminal plasma of patients with CBP and CABP contained higher levels of IL-6 compared with healthy subjects. IL-8 level was increased in small part of patients with CBP and CABP. Changes in cytokine status of patients with CBP and CABP that occurred during treatment and manifested in decrease of proinflammatory cytokines levels (IL-6 and IL-8) and increase of antiinflammatory cytokine level (IL-10) point to reduction of inflammatory process in prostate. Clinical effect of complex treatment in patients with CBP considering eradication of pathogen and shortening of duration of antibacterial treatment amounted 95%. Monotherapy of patients with CABP with Superlymph was effective in 72%.",2007,"Levels of pro- and anti-inflammatory cytokines (TNFalpha, IL-6, IL-8, IL-10) were studied in blood sera and seminal plasma of healthy volunteers and patients with chronic bacterial prostatitis (CBP) or chronic abacterial prostatitis (CABP).","['patients with CABP with', 'patients with CBP considering eradication of pathogen and shortening of duration of antibacterial treatment amounted 95', 'patients with chronic prostatitis during immunotherapy with natural complex of cytokines and antimicrobial peptides', 'healthy volunteers and patients with chronic bacterial prostatitis (CBP) or chronic abacterial prostatitis (CABP']","['immunotropic drug Superlymph', 'Superlymph']","['IL-8 level', 'levels of IL-6', 'Levels of pro- and anti-inflammatory cytokines (TNFalpha, IL-6, IL-8, IL-10', 'proinflammatory cytokines levels (IL-6 and IL-8) and increase of antiinflammatory cytokine level (IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis (disorder)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1720797', 'cui_str': 'Chronic Bacterial Prostatitis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033581', 'cui_str': 'Prostatitis (disorder)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0309049,"Levels of pro- and anti-inflammatory cytokines (TNFalpha, IL-6, IL-8, IL-10) were studied in blood sera and seminal plasma of healthy volunteers and patients with chronic bacterial prostatitis (CBP) or chronic abacterial prostatitis (CABP).","[{'ForeName': 'L V', 'Initials': 'LV', 'LastName': ""Koval'chuk"", 'Affiliation': ''}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Gankovskaia', 'Affiliation': ''}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Mazo', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Viriasov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1459,31343477,Ultrasonographic Detection of Micro-Bubbles in the Right Atrium to Confirm Peripheral Venous Catheter Position in Children.,"OBJECTIVES


In pediatric patients, indwelling peripheral venous catheters are sometimes displaced to extravascular positions, causing infiltration or extravasation. No reliable techniques are available to confirm accurate IV catheterization. However, ultrasonographic detection of micro-bubble turbulence in the right atrium after saline injection has been reported to be useful in confirming central venous catheter positions in both adults and children. This study evaluated whether this micro-bubble detection test can offer better confirmation of peripheral venous catheter positions compared with the smooth saline injection technique in pediatric patients.
DESIGN


Randomized controlled study.
SETTING


Single tertiary PICU.
PATIENTS


Pediatric patients (weighing < 15 kg) who already had or required a peripheral venous catheter.
INTERVENTIONS


Patients were randomly allocated to either of the two groups (150 patients per group): undergoing either the micro-bubble detection test (M group) or the smooth saline injection test (S group).
MEASUREMENTS AND MAIN RESULTS


The peripheral venous catheters were confirmed to be IV located in the final position in 137 and 139 patients in the M and S groups, respectively. In properly located catheters, the tests were positive in 100% (n = 137/137; sensitivity, 100%; 95% CI, 97.8-100), and in 89% (n = 124/139; 95% CI, 82.8-93.8) of the M and S groups, respectively (p = 0.0001). Among the catheters located in extravascular positions, the tests were negative in 100% (n = 13/13; specificity, 100%; 95% CI, 79.4-100), and in 64% (n = 7/11; 95% CI, 30.8-89.1) of the M and S groups, respectively (p = 0.017).
CONCLUSIONS


The micro-bubble detection test is a useful technique for detecting extravasation and confirming proper positioning of peripheral IV catheters in pediatric patients.",2019,"In properly located catheters, the tests were positive in 100% (n = 137/137; sensitivity, 100%; 95% CI, 97.8-100), and in 89% (n = 124/139; 95% CI, 82.8-93.8) of the M and S groups, respectively (p = 0.0001).","['Pediatric patients (weighing < 15 kg) who already had or required a peripheral venous catheter', 'pediatric patients', 'Children']","['smooth saline injection technique', 'micro-bubble detection test (M group) or the smooth saline injection test (S group']","['Ultrasonographic Detection of Micro-Bubbles', 'peripheral venous catheters']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}]",150.0,0.0709005,"In properly located catheters, the tests were positive in 100% (n = 137/137; sensitivity, 100%; 95% CI, 97.8-100), and in 89% (n = 124/139; 95% CI, 82.8-93.8) of the M and S groups, respectively (p = 0.0001).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Nakajima', 'Affiliation': 'Department of Anesthesiology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Muneyuki', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Institute of Biomedical & Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan.'}]",Critical care medicine,['10.1097/CCM.0000000000003916']
1460,31982647,A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol.,"INTRODUCTION


The transition from high school to college is a developmentally sensitive period that is high-risk for the escalation of alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. College alcohol interventions target drinking directly at a time when students may be uninterested in changing their drinking. Approaches that indirectly target drinking may be particularly effective. Behavioral activation (BA) is an intervention that indirectly addresses mental health conditions by guiding individuals to engage in reinforcing activities that align with their values (Lejuez et al., 2001). A pilot study of a BA intervention administered in a semester-long freshman orientation course reported a significant decrease in drinking-related problems compared to students in standard orientation course (Reynolds et al., 2011).
METHODS


The cluster-randomized trial will test the efficacy of BA administered in a semester-long (16 week) freshman orientation course, compared to a standard orientation course in 540 freshmen spread over 36 course sections (18 sections each). A 5-month post-treatment assessment will measure durability of effects.
DISCUSSION


The study will test a promising BA intervention that addresses factors limiting participation in other programs by targeting alcohol use indirectly and by integrating an intervention into college curriculum. This study represents a first step toward developing an intervention course that could be widely disseminated to address the persistent college drinking problem and its consequences.
CLINICAL TRIALS REGISTRATION NUMBER


NCT04038190.",2020,"A pilot study of a BA intervention administered in a semester-long freshman orientation course reported a significant decrease in drinking-related problems compared to students in standard orientation course (Reynolds et al., 2011).
",[],"['BA', 'Behavioral activation (BA', 'BA intervention', 'behavioral activation intervention']",['drinking-related problems'],[],[],"[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0191295,"A pilot study of a BA intervention administered in a semester-long freshman orientation course reported a significant decrease in drinking-related problems compared to students in standard orientation course (Reynolds et al., 2011).
","[{'ForeName': 'Tera L', 'Initials': 'TL', 'LastName': 'Fazzino', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, United States of America; Department of Psychology, University of Kansas, United States of America. Electronic address: tfazzino@ku.edu.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Lejuez', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, United States of America; Department of Psychology, University of Kansas, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, United States of America; Department of Psychology, University of Kansas, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105950']
1461,17886373,[Affinoleukin in combined treatment of psoriasis].,"Open randomized controlled clinical trials in which 161 patients were included showed that Affinoleukin (commercial drug which contains low molecular weight proteins obtained from extract of human leukocytes membranes) was effective in treatment of psoriasis. Affinoleukin, when added to regular treatment, accelerated the establishment of remission and its duration by restoration of impaired regulatory and defensive functions of T-lymphocytes, particularly, gamma deltaT- and NKT-cells as well as monocytes and NK-cells. Regular treatment led to marked positive effect in 45% of patients with severe psoriasis and psoriasis of intermediate severity. Addition of Affinoleukin in combined treatment increased proportion of patients with marked positive effect to 72%. Magnitude of Affinoleukin effect was directly related with its dose and severity of psoriasis. Course of Affinoleukin injections (up to 30 units in adults) is worthwhile to use as immunobiological component of combined treatment of exacerbations of severe psoriasis and psoriasis of intermediate severity.",2007,"Affinoleukin, when added to regular treatment, accelerated the establishment of remission and its duration by restoration of impaired regulatory and defensive functions of T-lymphocytes, particularly, gamma deltaT- and NKT-cells as well as monocytes and NK-cells.","['161 patients', 'psoriasis', 'patients with severe psoriasis and psoriasis of intermediate severity']","['Affinoleukin', 'Affinoleukin injections', 'Affinoleukin (commercial drug which contains low molecular weight proteins obtained from extract of human leukocytes membranes']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]",[],161.0,0.0276931,"Affinoleukin, when added to regular treatment, accelerated the establishment of remission and its duration by restoration of impaired regulatory and defensive functions of T-lymphocytes, particularly, gamma deltaT- and NKT-cells as well as monocytes and NK-cells.","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Mats', 'Affiliation': ''}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Znamenskaia', 'Affiliation': ''}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Fattiakhetdinova', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Iashin', 'Affiliation': ''}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Denisova', 'Affiliation': ''}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Trofimova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1462,32011369,Reply to the Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.0971855,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001159']
1463,31720819,Post-stroke cognitive impairment as an independent predictor of ischemic stroke recurrence: PICASSO sub-study.,"INTRODUCTION


To devise appropriate preventive strategies after stroke, knowledge of the association between post-stroke cognitive impairment (PSCI) and prognosis of stroke patients is important. We investigated the association between PSCI and the vascular outcomes in patients with ischemic stroke with best medical care considering their risk factors and adherence to medications.
METHODS


Of the 1534 ischemic stroke patients who randomly assigned to aspirin or cilostazol treatment with best medical therapy by the PICASSO (PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage) trial, 1240 with baseline mini-mental state examination (MMSE) scores were analysed retrospectively. The patients were classified into three groups based on MMSE scores. Recurrence of ischemic stroke, stroke of any type and composite of major vascular events were compared among them.
RESULTS


Of the 1240 patients, 376 had MMSE scores of 28-30 (highest tertile), 419 had scores of 24-27 (middle tertile) and 445 had scores of 0-23 (lowest tertile). The average time from stroke onset to MMSE examination was 31.8 days. By trend analysis, lower tertile of MMSE score was significantly associated with recurrent ischemic stroke (p = 0.0017), stroke of any type (p = 0.0053) and composite vascular outcome (p = 0.0122). After adjustment for covariates, PSCI was independently associated with risk of recurrent ischemic stroke (HR 2.40, 95% confidence interval 1.12-5.14).
CONCLUSIONS


Cognitive impairment was associated with recurrence of ischemic stroke in high risk patients during adequate medical therapy including antiplatelet therapy. However, the other vascular events were not.",2020,"By trend analysis, lower tertile of MMSE score was significantly associated with recurrent ischemic stroke (p = 0.0017), stroke of any type (p = 0.0053) and composite vascular outcome (p = 0.0122).","['patients with ischemic stroke with best medical care considering their risk factors and adherence to medications', 'iSchemic Stroke patients with high risk of cerebral hemOrrhage) trial, 1240 with baseline mini-mental state examination', '1240 patients', 'Of the 1534 ischemic stroke patients who randomly assigned to']",['aspirin or cilostazol treatment with best medical therapy by the PICASSO (PreventIon of CArdiovascular events'],"['Recurrence of ischemic stroke, stroke of any type and composite of major vascular events', 'MMSE) scores', 'risk of recurrent ischemic stroke', 'composite vascular outcome', 'MMSE score', 'stroke of any type', 'recurrent ischemic stroke', 'MMSE scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",1240.0,0.097577,"By trend analysis, lower tertile of MMSE score was significantly associated with recurrent ischemic stroke (p = 0.0017), stroke of any type (p = 0.0053) and composite vascular outcome (p = 0.0122).","[{'ForeName': 'Hyuk Sung', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dongwhane', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Min Hwan', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Sung', 'Initials': 'JS', 'LastName': 'Lim', 'Affiliation': 'Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Kyung-Ho', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Mi Sun', 'Initials': 'MS', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Ji-Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Keun-Sik', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Republic of Korea.'}, {'ForeName': 'Eun-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Dong-Wha', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Sun U', 'Initials': 'SU', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. sukwon@amc.seoul.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-019-09630-4']
1464,17882839,[Concept of inducing of rapid immunological protection against pathogens].,"Concept of construction of new type of vaccines for inducing rapid nonspecific immunological protection against pathogens by activation of innate immunity mechanisms has been formulated. Materials about formula of the concept, theses of theory of innate immunity, and experimental and clinical data, which confirm the concept, are presented. Results of studies with recombinant proinflammatorycytokines and synthetic ligands for Toll-like receptors as well as with polycomponent vaccine containing antigens of opportunistic bacteria (Immunovac VP-4) are also presented. Obtained data allowed to assume that activation of innate immunity mechanisms by preparations carrying pathogen-associated and molecular structures of microorganisms can result in formation of rapid and nonspecific protection against any pathogen.",2007,Concept of construction of new type of vaccines for inducing rapid nonspecific immunological protection against pathogens by activation of innate immunity mechanisms has been formulated.,[],['recombinant proinflammatorycytokines'],[],[],[],[],,0.0320044,Concept of construction of new type of vaccines for inducing rapid nonspecific immunological protection against pathogens by activation of innate immunity mechanisms has been formulated.,"[{'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Semenov', 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Zverev', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1465,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND


Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS.
METHODS


The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period.
RESULTS


The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2  = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
CONCLUSIONS


Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106']
1466,17674476,[T-cell and mediators of immune response in patients with acute hepatitis C treated with combined antiviral therapy].,"Study of cytokines spectrum in 32 patients with acute hepatitis C (AHC) treated with combined antiviral therapy (CAT) was performed. 30 patients with acute HCV-infection treated with basic treatment were followed also and formed control group. Levels of mediators of immune response in sera were measured by ELISA. Significant decrease of IL-1beta, TNF-alpha, CD8, and CD20 levels compared with control group was detected in patients with AHC treated with CAT. This could be explained by antifibrotic action of (lFN-alpha) and ribavirin which is determined by suppression of hepatic stellar cells activity. After completing of CAT course, increase of IL-2, IFN-alpha, IFN-gamma, CD4, and CD16 levels as well as increase of immunoregulatory coefficient compared with values before treatment was observed as a result of appropriate biological mechanisms of interaction between antiviral drugs and human organism. Apart from antiviral action of CAT, other immunoregulatory effects of such treatment were determined. Significant increase of IL-2, IFN-gamma, and IFN-alpha levels in patients with stable virological response to 2nd week of CAT characterized high effector potential of Th1-lymphocytes that promoted suppression of active viral replication, virus elimination and was an early criterion of aniviral treatment effectiveness.",2007,"Significant decrease of IL-1beta, TNF-alpha, CD8, and CD20 levels compared with control group was detected in patients with AHC treated with CAT.","['30 patients with acute HCV-infection treated with basic treatment', '32 patients with acute hepatitis C (AHC) treated with', 'patients with acute hepatitis C treated with']","['ribavirin', 'CAT', 'combined antiviral therapy (CAT', 'combined antiviral therapy']","['IL-2, IFN-alpha, IFN-gamma, CD4, and CD16 levels', 'Levels of mediators of immune response', 'IL-1beta, TNF-alpha, CD8, and CD20 levels', 'IL-2, IFN-gamma, and IFN-alpha levels', 'immunoregulatory coefficient']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0400914', 'cui_str': 'Acute hepatitis C (disorder)'}]","[{'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}]","[{'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0301974', 'cui_str': 'Mediator of immune response (substance)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",30.0,0.0189506,"Significant decrease of IL-1beta, TNF-alpha, CD8, and CD20 levels compared with control group was detected in patients with AHC treated with CAT.","[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Sobchak', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1467,31461138,Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients With Trauma and Hemorrhagic Shock: A Randomized Clinical Trial.,"Importance


Current therapies for traumatic blood loss focus on hemorrhage control and blood volume replacement. Severe hemorrhagic shock, however, is associated with a state of arginine vasopressin (AVP) deficiency, and supplementation of this hormone may decrease the need for blood products in resuscitation.
Objective


To determine whether low-dose supplementation of AVP in patients with trauma (hereinafter referred to as trauma patients) and with hemorrhagic shock decreases their need for transfused blood products during resuscitation.
Design, Setting, and Participants


This randomized, double-blind placebo-controlled clinical trial included adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017. Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment. Data were analyzed from May 1, 2013, through May 31, 2017, using intention to treat and per protocol.
Interventions


After administration of an AVP bolus (4 U) or placebo, participants received AVP (≤0.04 U/min) or placebo for 48 hours to maintain a mean arterial blood pressure of at least 65 mm Hg.
Main Outcomes


The primary outcome was total volume of blood product transfused. Secondary end points included total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality.
Results


One hundred patients underwent randomization (49 to the AVP group and 51 to the placebo group). Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n = 93) with penetrating trauma (n = 79). Cohort characteristics before randomization were well balanced. At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22). Although the groups had similar rates of mortality (6 of 49 [12%] vs 6 of 51 [12%]; P = .94) and total complications (24 of 44 [55%] vs 30 of 47 [64%]; P = .37), the AVP group had less deep venous thrombosis (5 of 44 [11%] vs 16 of 47 [34%]; P = .02).
Conclusions and Relevance


Low-dose AVP during the resuscitation of trauma patients in hemorrhagic shock decreases blood product requirements. Additional research is necessary to determine whether including AVP improves morbidity or mortality.
Trial Registration


ClinicalTrials.gov identifier: NCT01611935.",2019,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","['Patients With Trauma and Hemorrhagic Shock', 'patients with trauma', 'adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017', 'Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment', 'Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n\u2009=\u200993) with penetrating trauma (n\u2009=\u200979', 'One hundred patients underwent randomization (49 to the AVP group and 51 to the']","['AVP bolus (4 U) or placebo', 'AVP (≤0.04 U/min) or placebo', 'AVP', 'placebo', 'Arginine Vasopressin']","['Severe hemorrhagic shock', 'total complications', 'Blood Product Transfusions', 'total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality', 'total volume of blood product transfused', 'deep venous thrombosis', 'rates of mortality', 'blood products']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0403447', 'cui_str': 'Renal Insufficiency, Chronic'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532693', 'cui_str': 'Units per minute'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",100.0,0.742006,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","[{'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Sims', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Holena', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Neils', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Seamon', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Shiroff', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Shariq', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Kaplan', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grill', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Mason', 'Affiliation': 'Department of Anesthesia, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Abella', 'Affiliation': 'Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}]",JAMA surgery,['10.1001/jamasurg.2019.2884']
1468,32428865,"Remdesivir in COVID-19: A critical review of pharmacology, pre-clinical and clinical studies.","BACKGROUND & AIMS


Remdesivir is a broad spectrum anti-viral drug that has shown to inhibit SARS-CoV-2, in vitro and in vivo. In absence of any effective treatment for SARS-CoV-2 infection (COVID-19), remdesivir has been tried for a compassionate use in severe COVID-19. Newer randomized controlled studies that have recently become available, showed a mixed result. We aimed to systematically search the literature to understand the pharmacology and clinical effects of remdesivir in patients with COVID-19.
METHODS


We systematically searched the PubMed, ClinicalTrial.Org and MedRxiv database up till May 5, 2020 using specific key words such as ""Remdesivir"" or 'GS-5734″ AND ""COVID-19"" or ""SARS-CoV-2"" and retrieved all the article published in English language, that have reported the pharmacology and the clinical outcomes of remdesivir in patients with COVID-19.
RESULTS


Initial compassionate use of remdesivir has shown a fairly good result, but difficult to quantify, in the absence of control arm. While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
CONCLUSIONS


Remdesivir has shown a mixed result in patients with COVID-19 with an acceptable side effect. However, jury is still out while awaiting the results from the forthcoming trials.",2020,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","['Remdesivir in COVID-19', 'patients with COVID-19']",['placebo'],['mortality'],"[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.151411,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","[{'ForeName': 'Awadhesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Diabetes & Endocrinology, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India. Electronic address: draksingh_2001@yahoo.com.'}, {'ForeName': 'Akriti', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'College of Medicine and JNM Hospital, Kalyani, Nadia, West Bengal, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Gynaecology & Obstetrics, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Fortis C-DOC Hospital for Diabetes and Allied Sciences, New Delhi, India.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.018']
1469,32434884,HIV RNA Rebound in Seminal Plasma after Antiretroviral Treatment Interruption.,"If strategies currently in development succeed in eradicating HIV reservoirs in peripheral blood and lymphoid tissues, residual sources of virus may remain in anatomic compartments. Paired blood and semen samples were collected from 12 individuals enrolled in a randomized, double-blind, placebo-controlled therapeutic vaccine clinical trial in people with HIV (PWH) who began antiretroviral therapy (ART) during acute or early infection (ClinicalTrials registration no. NCT01859325). After the week 56 visit (postintervention), all participants interrupted ART. At the first available time points after viral rebound, we sequenced HIV-1  env  (C2-V3),  gag  (p24), and  pol  (reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma using the MiSeq Illumina platform. Comprehensive sequence and phylogenetic analyses were performed to evaluate viral population structure, compartmentalization, and viral diversity in blood and seminal plasma. Compared to that in blood, HIV RNA rebound in semen occurred significantly later (median of 66 versus 42 days post-ART interruption,  P  < 0.01) and reached lower levels (median 164 versus 16,090 copies/ml,  P  < 0.01). Three of five participants with available sequencing data presented compartmentalized viral rebound between blood and semen in one HIV coding region. Despite early ART initiation, HIV RNA molecular diversity was higher in semen than in blood in all three coding regions for most participants. Higher HIV RNA molecular diversity in the genital tract (compared to that in blood plasma) and evidence of compartmentalization illustrate the distinct evolutionary dynamics between these two compartments after ART interruption. Future research should evaluate whether the genital compartment might contribute to viral rebound in some PWH interrupting ART. IMPORTANCE  To cure HIV, we likely need to target the reservoirs in all anatomic compartments. Here, we used sophisticated statistical and phylogenetic methods to analyze blood and semen samples collected from 12 persons with HIV who began antiretroviral therapy (ART) during very early HIV infection and who interrupted their ART as part of a clinical trial. First, we found that HIV RNA rebound in semen occurred significantly later and reached lower levels than in blood. Second, we found that the virus in semen was genetically different in some participants compared to that in blood. Finally, we found increased HIV RNA molecular diversity in semen compared to that in blood in almost all study participants. These data suggest that the HIV RNA populations emerging from the genital compartment after ART interruption might not be the same as those emerging from blood plasma. Future research should evaluate whether the genital compartment might contribute to viral rebound in some people with HIV (PWH) interrupting ART.",2020,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","['clinical trial in people with HIV (PWH) who began ART during acute or early infection (NCT01859325', '12 individuals enrolled', '12 persons with HIV who began antiretroviral therapy (ART) during very early HIV-infection and who interrupted their ART as part of a clinical trial']","['placebo-controlled therapeutic vaccine', 'antiretroviral therapy (ART']","['sequenced HIV-1  env  ( C2-V3 ),  gag (p24),  and  pol ( reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma', 'viral population structure, compartmentalization and viral diversity in blood and seminal plasma', 'HIV RNA rebound in semen', 'blood, HIV RNA rebound in semen', 'HIV RNA molecular diversity']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042210', 'cui_str': 'Vaccine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877595', 'cui_str': 'HIV RNA rebound'}]",5.0,0.115519,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gianella', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA gianella@ucsd.edu.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Chaillon', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Tae-Wook', 'Initials': 'TW', 'LastName': 'Chun', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Sneller', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ignacio', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Milenka V', 'Initials': 'MV', 'LastName': 'Vargas-Meneses', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Caballero', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Ellis', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Kovacs', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Benko', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Huibner', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Kaul', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Journal of virology,['10.1128/JVI.00415-20']
1470,32068550,CORR Insights®: Does An Augmented Reality-based Portable Navigation System Improve the Accuracy of Acetabular Component Orientation During THA? A Randomized Controlled Trial.,,2020,,[],['CORR Insights®'],['Accuracy of Acetabular Component Orientation'],[],[],"[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}]",,0.134137,,"[{'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Ponce', 'Affiliation': 'B. A. Ponce, Professor, Vice Chair Clinical Affairs, University of Alabama at Birmingham, Department of Orthopaedic Surgery, Birmingham, AL, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001174']
1471,32061188,START: single-to-double arm transition design for phase II clinical trials.,"Phase II clinical trials designed for evaluating a drug's treatment effect can be either single-arm or double-arm. A single-arm design tests the null hypothesis that the response rate of a new drug is lower than a fixed threshold, whereas a double-arm scheme takes a more objective comparison of the response rate between the new treatment and the standard of care through randomization. Although the randomized design is the gold standard for efficacy assessment, various situations may arise where a single-arm pilot study prior to a randomized trial is necessary. To combine the single- and double-arm phases and pool the information together for better decision making, we propose a Single-To-double ARm Transition design (START) with switching hypotheses tests, where the first stage compares the new drug's response rate with a minimum required level and imposes a continuation criterion, and the second stage utilizes randomization to determine the treatment's superiority. We develop a software package in R to calibrate the frequentist error rates and perform simulation studies to assess the trial characteristics. Finally, a metastatic pancreatic cancer trial is used for illustrating the decision rules under the proposed START design.",2020,"A single-arm design tests the null hypothesis that the response rate of a new drug is lower than a fixed threshold, whereas a double-arm scheme takes a more objective comparison of the response rate between the new treatment and the standard of care through randomization.",[],[],[],[],[],[],,0.151021,"A single-arm design tests the null hypothesis that the response rate of a new drug is lower than a fixed threshold, whereas a double-arm scheme takes a more objective comparison of the response rate between the new treatment and the standard of care through randomization.","[{'ForeName': 'Haolun', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Statistics and Actuarial Science, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Pok Fu Lam Road, Hong Kong.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Yin', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Pok Fu Lam Road, Hong Kong.'}]",Pharmaceutical statistics,['10.1002/pst.2005']
1472,31084573,Two to Tango or the More the Merrier? A Randomized Controlled Trial of the Effects of Group Size in Aphasia Conversation Treatment on Standardized Tests.,"Purpose Group conversation treatment has the potential to improve communication and reduce social isolation for people with aphasia. This project examined how 2 conflicting hypotheses-treatment dosage and group dynamics-affect treatment outcomes. Method Forty-eight participants with chronic aphasia were randomly assigned to either a dyad, a large group, or a delayed control group. Conversation group treatment was provided for an hour, twice per week, for 10 weeks. Individual goals were developed by each participant and addressed in the context of thematically oriented conversation treatment. Standardized testing across language domains was completed pretreatment (Time 1), posttreatment (Time 2), at a 6-week maintenance point (Time 3), and at 11-month follow-up for the experimental groups. Results Treatment groups showed greater changes on standardized measures than the control group posttreatment. Dyads showed the most changes on measures of language impairment, whereas changes on the self-reported functional communication measure (Aphasia Communication Outcome Measure) and connected speech task only showed significant changes in the large group. Conclusions This randomized controlled trial on conversation treatment indicated that both treatment groups-but not the delayed control group-showed significant changes on standardized tests. Hence, conversation treatment is associated with changes in measures of language impairment and quality of life. Dyads showed the most changes on measures of language impairment, whereas changes on the functional communication measure (Aphasia Communication Outcome Measure) and discourse production only showed significant changes in the large group. Thus, group size may be associated with effects on different types of outcome measures.",2019,"Dyads showed the most changes on measures of language impairment, whereas changes on the functional communication measure (Aphasia Communication Outcome Measure) and discourse production only showed significant changes in the large group.","['people with aphasia', 'Method Forty-eight participants with chronic aphasia']","['delayed control group', 'Group Size in Aphasia Conversation Treatment']","['functional communication measure (Aphasia Communication Outcome Measure) and discourse production', 'language impairment and quality of life', 'language impairment', 'standardized measures', 'self-reported functional communication measure (Aphasia Communication Outcome Measure) and connected speech task']","[{'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0033268'}, {'cui': 'C0023015', 'cui_str': 'Language Disorders'}, {'cui': 'C0034380'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",48.0,0.0196742,"Dyads showed the most changes on measures of language impairment, whereas changes on the functional communication measure (Aphasia Communication Outcome Measure) and discourse production only showed significant changes in the large group.","[{'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'DeDe', 'Affiliation': 'Department of Communication Sciences and Disorders, Temple University, Philadelphia, PA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hoover', 'Affiliation': 'Department of Speech, Language and Hearing Sciences, Boston University, MA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Maas', 'Affiliation': 'Department of Communication Sciences and Disorders, Temple University, Philadelphia, PA.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-18-0404']
1473,32076783,Tranexamic acid in traumatic brain injury: an explanatory study nested within the CRASH-3 trial.,"PURPOSE


The CRASH-3 trial is a randomised trial of tranexamic acid (TXA) on death and disability in patients with traumatic brain injury (TBI). It is based on the hypothesis that early TXA treatment can prevent deaths from post-traumatic intracranial bleeding. The results showed that timely TXA treatment reduces head injury deaths in patients with reactive pupils and those with a mild to moderate GCS at baseline. We examined routinely collected CT scans in a sample of 1767 CRASH-3 trial patients to explore if, why, and how patients are affected by TXA.
METHODS


The CRASH-3 IBMS is an explanatory study nested within the CRASH-3 trial. We measured the volume of intracranial bleeding on CT scans using established methods (e.g. ABC/2).
RESULTS


Patients with any un-reactive pupil had a median intracranial bleeding volume of 60 ml (IQR 18-101 ml) and patients with reactive pupils had a median volume of 26 ml (IQR 1-55 ml). Patients with severe GCS had median intracranial bleeding volume of 37 ml (IQR 3-75 ml) and patients with moderate to mild GCS had a median volume of 26 ml (IQR 0.4-50 ml). For every hour increase from injury to the baseline scan, the risk of new bleeding on a further scan decreased by 12% (adjusted RR = 0.88 [95% CI 0.80-0.96], p = 0.0047).
CONCLUSION


Patients with reactive pupils and/or mild to moderate GCS may have benefited from TXA in the CRASH-3 trial because they had less intracranial bleeding at baseline. However, because bleeding occurs soon after injury, treatment delay reduces the benefit of TXA.",2020,"RESULTS


Patients with any un-reactive pupil had a median intracranial bleeding volume of 60 ml (IQR 18-101 ml) and patients with reactive pupils had a median volume of 26 ml (IQR 1-55 ml).","['Patients with reactive pupils and/or mild to moderate GCS', 'traumatic brain injury', 'patients with traumatic brain injury (TBI', 'Patients with any un-reactive pupil']","['tranexamic acid (TXA', 'TXA', 'Tranexamic acid']","['death and disability', 'risk of new bleeding on a further scan', 'head injury deaths', 'intracranial bleeding', 'median intracranial bleeding volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.150224,"RESULTS


Patients with any un-reactive pupil had a median intracranial bleeding volume of 60 ml (IQR 18-101 ml) and patients with reactive pupils had a median volume of 26 ml (IQR 1-55 ml).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-020-01316-1']
1474,32119749,Effects of Odanacatib on Bone Structure and Quality in Postmenopausal Women With Osteoporosis: 5-Year Data From the Phase 3 Long-Term Odanacatib Fracture Trial (LOFT) and its Extension.,"Odanacatib (ODN), a selective oral inhibitor of cathepsin K, was an investigational agent previously in development for the treatment of osteoporosis. In this analysis, the effects of ODN on bone remodeling/modeling and structure were examined in the randomized, double-blind, placebo-controlled, event-driven, Phase 3, Long-term Odanacatib Fracture Trial (LOFT; NCT00529373) and planned double-blind extension in postmenopausal women with osteoporosis. A total of 386 transilial bone biopsies, obtained from consenting patients at baseline (ODN n = 17, placebo n = 23), month 24 (ODN n = 112, placebo n = 104), month 36 (ODN n = 42, placebo n = 41), and month 60 (ODN n = 27, placebo n = 20) were assessed by dynamic and static bone histomorphometry. Patient characteristics at baseline and BMD changes over 5 years for this subset were comparable to the overall LOFT population. Qualitative assessment of biopsies revealed no abnormalities. Consistent with the mechanism of ODN, osteoclast number was higher with ODN versus placebo over time. Regarding bone remodeling, dynamic bone formation indices in trabecular, intracortical, and endocortical surfaces were generally similar in ODN-treated versus placebo-treated patients after 2 years of treatment. Regarding periosteal modeling, the proportion of patients with periosteal double labels and the bone formation indices increased over time in the ODN-treated patients compared with placebo. This finding supported the observed numerical increase in cortical thickness at month 60 versus placebo. In conclusion, ODN treatment for 5 years did not reduce bone remodeling and increased the proportion of patients with periosteal bone formation. These results are consistent with the mechanism of action of ODN, and are associated with continued BMD increases and reduced risk of fractures compared with placebo in the LOFT Phase 3 fracture trial. © 2020 American Society for Bone and Mineral Research.",2020,"Regarding bone remodeling, dynamic bone formation indices in trabecular, intracortical, and endocortical surfaces were generally similar in ODN- versus placebo-treated patients after 2 years' treatment.","['386 transilial bone biopsies, obtained from consenting patients at baseline (ODN n\xa0', 'n\xa0', 'postmenopausal women with osteoporosis', 'Postmenopausal Women with Osteoporosis']","['placebo', 'Odanacatib', 'ODN versus placebo', 'ODN']","['bone formation indices', 'cortical thickness', 'Bone Structure and Quality', 'BMD increases and reduced risk of fractures', 'bone remodeling', 'bone remodeling, dynamic bone formation indices in trabecular, intracortical, and endocortical surfaces']","[{'cui': 'C0005933', 'cui_str': 'Biopsy of bone (procedure)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2351970', 'cui_str': 'odanacatib'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",386.0,0.324823,"Regarding bone remodeling, dynamic bone formation indices in trabecular, intracortical, and endocortical surfaces were generally similar in ODN- versus placebo-treated patients after 2 years' treatment.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Recker', 'Affiliation': 'Osteoporosis Research Center, School of Medicine, Creighton University, Omaha, NE, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dempster', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, West Haverstraw and Columbia University, New York, NY, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Giezek', 'Affiliation': 'Biostatistics, MSD Europe Inc., Brussels, Belgium.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Biostatistics, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': 'Synexus Helderberg Clinical Research Centre, Somerset West, South Africa.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'de Villiers', 'Affiliation': 'Mediclinic Panorama and Department of Obstetrics & Gynaecology, University of Stellenbosch, Cape Town, South Africa.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Valter', 'Affiliation': 'Center for Clinical and Basic Research (CCBR), Tallinn, Estonia.'}, {'ForeName': 'Cristiano Af', 'Initials': 'CA', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigações Clínicas, São Paulo, Brazil.'}, {'ForeName': 'Dosinda', 'Initials': 'D', 'LastName': 'Cohn', 'Affiliation': 'Clinical Operations, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Santora', 'Affiliation': 'Clinical, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Le T', 'Initials': 'LT', 'LastName': 'Duong', 'Affiliation': 'Preclinical Discovery, Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3994']
1475,30797825,"Bench stepping with incremental heights improves muscle volume, strength and functional performance in older women.","AIM


Task-specific exercises such as bench stepping can improve functional ability and reduce falling incidents in older adults. However, such exercises are often not optimized to improve muscle volume and force-velocity characteristics. This study determined the effects of a 12-week stepping program using incremental step heights (STEEP), on muscle volume, strength, power, functional ability and balance performance in older women.
METHODS


Forty-five community-dwelling women (69y ± 4) were randomly assigned to the STEEP group or a non-training CONTROL group. Training intensity was primarily determined by step height, while training volume remained equal. Thigh muscle volume (CT-scan), force-velocity characteristics of the knee extensors (Biodex dynamometer) and functional ability (Short Physical Performance Battery, timed stair ascent, 10-m walk test and countermovement jump height) were determined pre- and post-intervention. In addition, 3D trunk accelerations were recorded at the lower back to assess balance during the Short Physical Performance Battery balance tests.
RESULTS


Two-way ANOVA showed that the STEEP program increased thigh muscle volume, knee extensor isometric peak torque, dynamic peak power, unloaded rate of velocity development and improved performance on all functional tests to a greater extent than CONTROL (p < .05), except the countermovement jump. No improvements were found for peak velocity and balance performance (p > .05).
CONCLUSION


Our results indicate that bench step training with incremental step heights simultaneously improves functional ability, thigh muscle volume and force-velocity characteristics of the knee extensors in older women.",2019,"ANOVA showed that the STEEP program increased thigh muscle volume, knee extensor isometric peak torque, dynamic peak power, unloaded rate of velocity development and improved performance on all functional tests to a greater extent than CONTROL (p < .05), except the countermovement jump.","['Forty-five community-dwelling women (69y\u202f±\u202f4', 'older women', 'older adults']","['stepping program using incremental step heights (STEEP', 'STEEP group or a non-training CONTROL group']","['Training intensity', 'thigh muscle volume, knee extensor isometric peak torque, dynamic peak power, unloaded rate of velocity development and improved performance on all functional tests', 'Thigh muscle volume (CT-scan), force-velocity characteristics of the knee extensors (Biodex dynamometer) and functional ability (Short Physical Performance Battery, timed stair ascent, 10-m walk test and countermovement jump height', 'muscle volume, strength, power, functional ability and balance performance', 'muscle volume, strength and functional performance', 'functional ability, thigh muscle volume and force-velocity characteristics', 'peak velocity and balance performance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0427127', 'cui_str': 'Step height (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3853978'}]",45.0,0.0161655,"ANOVA showed that the STEEP program increased thigh muscle volume, knee extensor isometric peak torque, dynamic peak power, unloaded rate of velocity development and improved performance on all functional tests to a greater extent than CONTROL (p < .05), except the countermovement jump.","[{'ForeName': 'Remco J', 'Initials': 'RJ', 'LastName': 'Baggen', 'Affiliation': 'Department of Movement Sciences, Physical Activity, Sports and Health Research Group, KU Leuven, Leuven, Belgium; Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: remco.baggen@kuleuven.be.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Van Roie', 'Affiliation': 'Department of Movement Sciences, Physical Activity, Sports and Health Research Group, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sabine M', 'Initials': 'SM', 'LastName': 'Verschueren', 'Affiliation': 'Department of Rehabilitation Sciences, Research Group for Musculoskeletal Rehabilitation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Van Driessche', 'Affiliation': 'Department of Movement Sciences, Physical Activity, Sports and Health Research Group, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Coudyzer', 'Affiliation': 'Department of Morphology and Medical Imaging, Faculty of Medicine, Radiology Section, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jaap H', 'Initials': 'JH', 'LastName': 'van Dieën', 'Affiliation': 'Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Delecluse', 'Affiliation': 'Department of Movement Sciences, Physical Activity, Sports and Health Research Group, KU Leuven, Leuven, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2019.02.013']
1476,32118602,"Letter to the Editor: The ""Cough Trick"" Reduces Pain During Removal of Closed-suction Drains after Total Knee Arthroplasty: A Randomized Trial.",,2020,,['after Total Knee Arthroplasty'],"['Cough Trick"" Reduces Pain During Removal of Closed-suction Drains', 'Letter to the Editor']",[],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.0531496,,"[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Tiwari', 'Affiliation': 'V. Tiwari, S. Dwidmuthe, S. S. Sahoo, All India Institute of Medical Sciences-Nagpur, Nagpur, Maharashtra, India.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Dwidmuthe', 'Affiliation': ''}, {'ForeName': 'Samrat Smrutiranjan', 'Initials': 'SS', 'LastName': 'Sahoo', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001204']
1477,32114073,Data for beta-blockade in ACLS - A trial sequential analysis.,,2020,,[],[],[],[],[],[],,0.123388,,"[{'ForeName': 'Mayuri', 'Initials': 'M', 'LastName': 'Manogaran', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Canada. Electronic address: mayuri.manogaran@mail.mcgill.ca.'}, {'ForeName': 'Stephen Su', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Canada; Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada.'}]",Resuscitation,['10.1016/j.resuscitation.2020.02.019']
1478,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND


Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
METHODS


We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
RESULTS


We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
CONCLUSION


It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026']
1479,32124549,Do children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation? A report from the Children's Oncology Group.,"BACKGROUND


The role of adjuvant radiotherapy (RT) remains unclear in patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS).
PROCEDURE


Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed. All patients received systemic chemotherapy and 36 Gy adjuvant RT (if given) to the primary site at week 12 or week 4 for D9602/D9803 and ARST0531, respectively.
RESULTS


Thirty-six patients with group I ARMS were treated on D9602 (n = 6), D9803 (n = 17), or ARST0531 (n = 13), of whom 24 (67%) were male. The median age was 4.1 years (range, 0.8-45.8). Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors > 5 cm. FOXO1-fusion status was negative, positive, and unknown in 10 (28%), 15 (42%), and 11 (30%) tumors, respectively. Twenty-two (61%) patients received RT. Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively. Patients with FOXO1 positivity who received RT had superior EFS compared with those who did not (77.8% vs 16.7%; P = 0.03). Among 10 patients who were FOXO1 negative, the outcome was similar with or without RT.
CONCLUSIONS


Although limited by a small sample size, data from this study support the routine use of adjuvant RT in patients with FOXO1-positive disease even after complete resection. Additionally, omitting adjuvant RT is rational for patients with FOXO1-negative ARMS and will be prospectively investigated in the current COG trial ARST1431.",2020,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[""Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed"", 'children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation', 'patients with FOXO1-positive disease even after complete resection', 'The median age was 4.1 years (range, 0.8-45.8', 'patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS', 'Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors\xa0>\xa05\xa0cm', 'Thirty-six patients with group', '10 patients who were FOXO1 negative, the outcome was similar with or without\xa0RT']","['adjuvant radiotherapy (RT', 'systemic chemotherapy and 36\xa0Gy adjuvant RT', 'RT']","['free survival (EFS) and overall survival (OS', 'superior EFS', 'FOXO1-fusion status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",36.0,0.138132,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Aye', 'Affiliation': ""Department of Pediatrics, Children's of Alabama, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Rudzinski', 'Affiliation': ""Department of Pathology, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Odion T', 'Initials': 'OT', 'LastName': 'Binitie', 'Affiliation': ""Department of Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Pediatric General and Thoracic Surgery, Cincinnati Children's Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Wolden', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Abha A', 'Initials': 'AA', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada.'}]",Pediatric blood & cancer,['10.1002/pbc.28243']
1480,2099071,[The determination of the optimal inoculation dose of an oral cholera chemical bivalent vaccine in a controlled experiment].,"276 volunteers aged 19 years and over were placed under observation in the course of the trial of oral cholera vaccine in tablets, containing choleragen toxoid, O-antigens of serovars Inaba and Ogawa and a number of Vibrio cholerae exoenzymes, for safety, reactogenic properties and immunological effectiveness. The vaccine was found to produce no reactions in a dose of 1-4 tablets; the administration of 3 tablets (300,000 binding units of the toxoid and 10,000 units of O-antigens, serovars Inaba and Ogawa) was shown to induce the most intensive synthesis of both antitoxins and vibriocidal antibodies in the blood sera of volunteers, as well as IgA coproantibodies. The oral vaccine was found to have an advantage over parenteral vaccines due to the absence of reactogenic properties and the formation of local immunity: coproantibodies appeared in 80% and 9% of the vaccinees respectively.",1990,The oral vaccine was found to have an advantage over parenteral vaccines due to the absence of reactogenic properties and the formation of local immunity: coproantibodies appeared in 80% and 9% of the vaccinees respectively.,['276 volunteers aged 19 years and over were placed under observation in the course of the trial of'],"['oral cholera chemical bivalent vaccine', 'oral cholera vaccine']",['formation of local immunity: coproantibodies'],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008354', 'cui_str': 'Vibrio cholerae Infection'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}]","[{'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]",276.0,0.0378485,The oral vaccine was found to have an advantage over parenteral vaccines due to the absence of reactogenic properties and the formation of local immunity: coproantibodies appeared in 80% and 9% of the vaccinees respectively.,"[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Sumarokov', 'Affiliation': ''}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Ivanov', 'Affiliation': ''}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Dzhaparidze', 'Affiliation': ''}, {'ForeName': 'Iu B', 'Initials': 'IuB', 'LastName': 'Reznikov', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rystsova', 'Affiliation': ''}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Nikitina', 'Affiliation': ''}, {'ForeName': 'L Ia', 'Initials': 'LIa', 'LastName': 'Matusevich', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Popov', 'Affiliation': ''}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Plotnikova', 'Affiliation': ''}, {'ForeName': 'V Ia', 'Initials': 'VIa', 'LastName': 'Shustov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1481,31513877,Effects of stepping exergames under stable versus unstable conditions on balance and strength in healthy community-dwelling older adults: A three-armed randomized controlled trial.,"OBJECTIVE


This non-blinded, three-armed randomized controlled trial aimed at comparing the effects of volitional step training under stable and unstable conditions on balance, mobility and strength adaptations.
METHODS


Fifty-one healthy and active older adults (age = 69.4 ± 5.6 years; BMI = 27.4 ± 4.6, physical activity = 9.2 ± 5.1 h/week) were allocated to either volitional stepping (VOL), volitional stepping under unstable conditions (VOL + US) or a control group (CON) using the minimization method. Participants underwent eight weeks of exergames based step training with three sessions per week. Pre- and Post-testing included reactive balance (postural sway upon perturbation), functional balance (Y-balance test) and mobility (timed up and go test) to compare the effects of both intervention groups. Strength was tested using the heel rise test and isometric leg extension and leg curl assessment to compare transfer effects of the intervention groups.
RESULTS


Data of 45 participants was finally analyzed. Adherence was 87 ± 5% in the VOL + US group and 86 ± 6% in the VOL group. No adverse events occurred. Increased reactive balance was observed in VOL + US only (p < 0.05, standard mean difference (SMD) = 0.3) whereas both intervention groups improved functional balance (p < 0.05, SMD = 0.5-1.0). Only VOL + US led to improved functional mobility performance under dual-task conditions (p < 0.05, SMD = -0.4). Both VOL + US and VOL significantly improved calf strength endurance (p < 0.05, SMD = 0.7-0.8), whereas isometric strength of the thigh muscles revealed no significant changes (p > 0.05). Explosive strength (rate of force development) showed insignificant but medium interaction effects of the leg extensors in favor of VOL + US (p = 0.08, η 2 p  = 0.12, SMD = 0.2).
CONCLUSION


Volitional step training is an appealing and effective training tool to improve functional balance and calf strength in healthy older adults. Unstable volitional stepping seems to be superior in improving reactive balance and functional mobility under dual-task conditions. It appears that the volitional stepping under unstable conditions requires motor skills relevant for preventing falls since it is more tasks specific when compared to volitional stepping under stable conditions.",2019,"Only VOL + US led to improved functional mobility performance under dual-task conditions (p < 0.05, SMD = -0.4).","['45 participants was finally analyzed', 'healthy older adults', 'healthy community-dwelling older adults', 'Fifty-one healthy and active older adults (age\u202f=\u202f69.4\u202f±\u202f5.6\u202fyears; BMI\u202f=\u202f27.4\u202f±\u202f4.6, physical activity\u202f=\u202f9.2\u202f±\u202f5.1\u202fh/week']","['volitional step training', 'Volitional step training', 'stepping exergames under stable versus unstable conditions', 'volitional stepping (VOL), volitional stepping under unstable conditions (VOL\u202f+\u202fUS) or a control group (CON']","['functional balance', 'Increased reactive balance', 'balance and strength', 'calf strength endurance', 'functional balance and calf strength', 'balance, mobility and strength adaptations', 'reactive balance (postural sway upon perturbation), functional balance (Y-balance test) and mobility (timed up and go test', 'functional mobility performance under dual-task conditions', 'Explosive strength', 'isometric strength of the thigh muscles']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",51.0,0.0156721,"Only VOL + US led to improved functional mobility performance under dual-task conditions (p < 0.05, SMD = -0.4).","[{'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Morat', 'Affiliation': 'Department of Intervention Research in Exercise Training, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany. Electronic address: m.morat@dshs-koeln.de.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Intervention Research in Exercise Training, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Hammes', 'Affiliation': 'Department of Intervention Research in Exercise Training, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Morat', 'Affiliation': 'Institute of Movement and Sport Gerontology, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany. Electronic address: t.morat@dshs-koeln.de.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Giannouli', 'Affiliation': 'Institute of Movement and Sport Gerontology, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany. Electronic address: e.giannouli@dshs-koeln.de.'}, {'ForeName': 'Wiebren', 'Initials': 'W', 'LastName': 'Zijlstra', 'Affiliation': 'Institute of Movement and Sport Gerontology, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany. Electronic address: zijlstra@dshs-koeln.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Department of Intervention Research in Exercise Training, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany. Electronic address: l.donath@dshs-koeln.de.'}]",Experimental gerontology,['10.1016/j.exger.2019.110719']
1482,31483181,Is the efficacy of repetitive transcranial magnetic stimulation influenced by baseline severity of fatigue symptom in patients with myalgic encephalomyelitis.,"Objectives:  Recently, repetitive transcranial magnetic stimulation (rTMS) has been therapeutically applied for patients with myalgic encephalomyelitis (ME). However, it is still unclear which clinical factors could influence the efficacy of rTMS for ME patients. The purpose of this study is to clarify whether baseline severity of fatigue symptom would influence the efficacy of rTMS applied for ME patients. Methods:  Twenty-two patients with ME were studied. Each patient was hospitalized to receive 6-8 sessions of rTMS. In this study, high-frequency rTMS of 10 Hz was applied over prefrontal cortex. To evaluate the severity of fatigue symptom, Brief Fatigue Inventory (BFI) score and Visual Analogue Scale (VAS) rate were applied before and after rTMS application. Based on the BFI score before rTMS, the patients were divided into two groups: 'severe group' ( n  = 9) and 'mild group' ( n  = 13). We compared the extent of the improvements of fatigue symptom between two groups. Results:  In severe group, compared to before rTMS, VAS rate was significantly lower not only at discharge but also 2 weeks after discharge. Similarly, mild group also showed significant decrease in VAS rate at the same timepoints. However, the extent of VAS rate change did not differ between two groups. In addition, no significant correlation between baseline score of BFI and the changes in VAS rate was indicated. Conclusions:  It can be concluded that rTMS can improve fatigue symptom in ME patients regardless of baseline severity of fatigue symptom. It is expected that rTMS can be a novel therapeutic intervention for ME patients.",2020,"In severe group, compared to before rTMS, VAS rate was significantly lower not only at discharge but also 2 weeks after discharge.","['patients with myalgic encephalomyelitis', 'patients with myalgic encephalomyelitis (ME', 'Twenty-two patients with ME were studied', 'ME patients']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation']","['VAS rate', 'BFI score', 'severity of fatigue symptom, Brief Fatigue Inventory (BFI) score and Visual Analogue Scale (VAS) rate', 'VAS rate change', 'fatigue symptom']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015674', 'cui_str': 'Systemic Exertion Intolerance Disease'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",22.0,0.0170277,"In severe group, compared to before rTMS, VAS rate was significantly lower not only at discharge but also 2 weeks after discharge.","[{'ForeName': 'De Gang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, International University of Health and Welfare, Chiba, Japan.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gu', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, International University of Health and Welfare, Chiba, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Kubo', 'Affiliation': 'Department of Neurology and Stroke Center, Southern Tohoku Research Institute for Neuroscience, Southern Tohoku General Hospital, Fukushima, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Kakuda', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, International University of Health and Welfare, Chiba, Japan.'}]",The International journal of neuroscience,['10.1080/00207454.2019.1663189']
1483,17163135,"[Results of Russian multicenter trial of immunogenicity, reactogenicity and safety of new combination vaccine against hepatitis A and B (Twinrix)].","Results of registration trial of combination vaccine for prevention of hepatitis A and B are presented. The trial was conducted in 5 centers of Russia in 2004-2005 with full accordance to good clinical practice requirements and standards for multicenter open randomized trials. Immunogenicity of studied combination vaccine Twinrix was evaluated in comparison with two simultaneously administered monovalent vaccines against hepatitis A and B (Havrix and Engerix-B) in 200 healthy subjects aged 18-40, which were seronegative to hepatitis A and B. Reactogenicity based on interviewed and non-interviewed symptoms ranged on intensity was assessed also. 1 month after completion of primary vaccination all subjects in both groups were seropositive to hepatitis A. Sero-protection level of antibodies to hepatitis B virus was detected in 98.9% of participants vaccinated with Twinrix and in 95.6% of participants vaccinated with Engerix-B and Havrix. Overall, reactogenicity of vaccines was minor, marked adverse events caused by vaccination were rare (approximately 1%). Study shows that combination vaccine against hepatitis A and B (Twinrix) at least non inferior in terms of immunogenicity, safety and tolerability to monovalent vaccines (Havrix and Engerix-B), were registered in Russia.",2006,1 month after completion of primary vaccination all subjects in both groups were seropositive to hepatitis A. Sero-protection level of antibodies to hepatitis B virus was detected in 98.9% of participants vaccinated with Twinrix and in 95.6% of participants vaccinated with Engerix-B and Havrix.,"['5 centers of Russia in 2004-2005 with full accordance to good clinical practice requirements and standards for multicenter open randomized trials', '200 healthy subjects aged 18-40, which were seronegative to hepatitis A and B. Reactogenicity based on interviewed and non-interviewed symptoms ranged on intensity was assessed also']","['monovalent vaccines against hepatitis A and B (Havrix and Engerix-B', 'combination vaccine', 'studied combination vaccine Twinrix', 'new combination vaccine against hepatitis A and B (Twinrix']","['Immunogenicity', 'immunogenicity, safety and tolerability', 'immunogenicity, reactogenicity and safety', 'seropositive to hepatitis A. Sero-protection level of antibodies to hepatitis B virus']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0019159', 'cui_str': 'Hepatitis, Infectious'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0019159', 'cui_str': 'Hepatitis, Infectious'}, {'cui': 'C0700881', 'cui_str': 'Havrix'}, {'cui': 'C0116078', 'cui_str': 'Engerix-B'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0593953', 'cui_str': 'Twinrix'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019164', 'cui_str': 'Anti-HBAg'}]",200.0,0.103719,1 month after completion of primary vaccination all subjects in both groups were seropositive to hepatitis A. Sero-protection level of antibodies to hepatitis B virus was detected in 98.9% of participants vaccinated with Twinrix and in 95.6% of participants vaccinated with Engerix-B and Havrix.,"[{'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Tatochenko', 'Affiliation': ''}, {'ForeName': 'N I', 'Initials': 'NI', 'LastName': ""Il'ina"", 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Romanenko', 'Affiliation': ''}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Alikova', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Fassakhov', 'Affiliation': ''}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Miasnikova', 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Patlusova', 'Affiliation': ''}, {'ForeName': 'Iu Iu', 'Initials': 'IuIu', 'LastName': 'Zima', 'Affiliation': ''}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Reshetnikova', 'Affiliation': ''}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Frolova', 'Affiliation': ''}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Smolenov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1484,16758905,[Mucosal immunity in children with HIV infection and the possibility of correcting this immunity].,"The influence of bacterial lysate [see text]PC-19 on the mucosal immunity of children with HIV infection was evaluated. The action of this topical immunomodulator was found to increase the synthesis of sIgA, which was indirectly reflected in a rise of the local immunity of the upper respiratory ways, preventing the aggravation of the chronic focal infection and the main disease. It should be pointed out that in a group of HIV-infected children and adolescents with an initially high level of salivary IgG the prescription of preparation [see text]PC-19 led to its considerable decrease. A decrease in the level of IgG and a rise in the content of sIgA in saliva under the action of the preparation correlated with a decrease in inflammatory changes in the nasopharyngeal mucosa. On the basis of results obtained in this study additions to the algorithm of the prophylactic medical observation of children and adolescents with HIV infection have been developed.",2006,A decrease in the level of IgG and a rise in the content of sIgA in saliva under the action of the preparation correlated with a decrease in inflammatory changes in the nasopharyngeal mucosa.,"['children with HIV infection', 'children and adolescents with HIV infection']",['bacterial lysate [see text]PC-19'],"['level of IgG', 'inflammatory changes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0300133,A decrease in the level of IgG and a rise in the content of sIgA in saliva under the action of the preparation correlated with a decrease in inflammatory changes in the nasopharyngeal mucosa.,"[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kostinov', 'Affiliation': ''}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Suloeva', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Tarasova', 'Affiliation': ''}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Lukushkina', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1485,31514191,Evaluating the Outcome of Two Different Regimes in Adhesive Capsulitis: A Prospective Clinical Study.,"OBJECTIVE


Adhesive capsulitis or frozen shoulder is a painful condition affecting up to 5% of the general population. We conducted this study with the aim of evaluating the results of physiotherapy plus intra-articular methylprednisolone injection versus physiotherapy alone in idiopathic frozen shoulder.
METHODS


This prospective clinical study was conducted in a tertiary care center between August 2016 and August 2018. Patients who were diagnosed with idiopathic frozen shoulder were included in the study, and each patient was randomly allocated to one of two groups: physiotherapy alone (group A) and physiotherapy plus intra-articular steroid injection (group B).
RESULTS


A total of 52 cases diagnosed with idiopathic frozen shoulder were included and treated with the two modalities. There was a significant improvement in group B compared to group A at 6 weeks and 3 months in the range of flexion, abduction, and external rotation. The Shoulder Pain and Disability Index showed improvement in both pain and disability score in group B -compared to group A, and improvement was significant at 6 weeks and 3 months.
CONCLUSION


The results demonstrate the advantages of physiotherapy plus intra-articular steroid injection in idiopathic frozen shoulder. The predictability of results with physiotherapy plus intra-articular steroid injection in selected patients is excellent, and it is a better modality of treatment compared to physiotherapy alone.",2020,"There was a significant improvement in Group B as compared to Group A at 6 weeks and 3 months in the range of flexion, abduction and external rotation.","['52 cases diagnosed with idiopathic frozen shoulder', 'tertiary care centre between August 2016 to August 2018', 'Patients who were diagnosed with idiopathic frozen shoulder were included in the study and each patient', 'idiopathic frozen shoulder', 'Adhesive Capsulitis']","['intra-articular methylprednisolone with physiotherapy versus physiotherapy alone', 'intra-articular steroid plus physiotherapy', 'physiotherapy alone and physiotherapy and intra articular injection', 'physiotherapy alone (Group A) and physiotherapy and intra-articular steroid injection (Group B']","['Shoulder pain and disability index (SPADI', 'pain and disability score']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0429527,"There was a significant improvement in Group B as compared to Group A at 6 weeks and 3 months in the range of flexion, abduction and external rotation.","[{'ForeName': 'Rashid', 'Initials': 'R', 'LastName': 'Anjum', 'Affiliation': 'ASCOMS & Hospital, Jammu, India, raashidanjum@gmail.com.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Aggarwal', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Gautam', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Aryan', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000503317']
1486,31488402,Nebulised hypertonic saline in moderate-to-severe bronchiolitis: a randomised clinical trial.,"OBJECTIVES


To investigate whether nebulised hypertonic saline (HS) treatment would decrease length of hospital stay (LOS) among infants with moderate-to severe-bronchiolitis compared with standard supportive care (SC).
METHODS


We conducted an open, multicentre, randomised clinical trial from 1 April 2013 to 31 March 2016, in Swiss children's hospitals. Patients aged 6 weeks to 24 months with a primary diagnosis of moderate or severe bronchiolitis were included. Children with previous episodes of wheezing, cardiac disease, chronic respiratory disease, immunodeficiency, prematurity (gestational age <34 weeks), corticotherapy in the preceding 2 weeks or inhaled bronchodilators within 24 hours before presentation were excluded. Patients were randomised to receive standard SC with nebulisation of 4 mL of 3% sodium chloride every 6 hours versus SSC. Main outcomes and measures were LOS duration of oxygen therapy, transfer to intensive care unit (ICU), readmission within 7 days following discharge and adverse events.
RESULTS


121 children were randomised. No statistically significant differences were found between treatment groups at baseline (age, Wang Score, atopic history, smoking exposure). Children in the HS group had a non-significant difference in length of stay -2.8 hours (-10; 16) compared with the SC group. There were no differences in oxygen therapy duration, transfer to ICU, readmission rate or adverse events. The intervention was discontinued at the parents' request in 16% of the cases.
CONCLUSION


Our study does not support the use of HS nebulisation in children with moderate to severe bronchiolitis.
TRIAL REGISTRATION NUMBER


NCT01812525.",2020,"No statistically significant differences were found between treatment groups at baseline (age, Wang Score, atopic history, smoking exposure).","['Children with previous episodes of wheezing, cardiac disease, chronic respiratory disease, immunodeficiency, prematurity (gestational age <34 weeks), corticotherapy in the preceding 2 weeks or inhaled bronchodilators within 24\u2009hours before presentation were excluded', 'moderate-to-severe bronchiolitis', ""1 April 2013 to 31 March 2016, in Swiss children's hospitals"", 'Patients aged 6 weeks to 24 months with a primary diagnosis of moderate or severe bronchiolitis were included', 'infants with moderate-to severe-bronchiolitis compared with standard supportive care (SC', 'children with moderate to severe bronchiolitis', '121 children']","['standard SC with nebulisation of 4\u2009mL of 3% sodium chloride every 6\u2009hours versus SSC', 'Nebulised hypertonic saline', 'HS nebulisation', 'nebulised hypertonic saline (HS']","['length of hospital stay (LOS', 'LOS duration of oxygen therapy, transfer to intensive care unit (ICU), readmission within 7 days following discharge and adverse events', 'oxygen therapy duration, transfer to ICU, readmission rate or adverse events', 'length of stay']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0021051', 'cui_str': 'Immunological Deficiency Syndromes'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1275717', 'cui_str': 'Transfer to ICU'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",121.0,0.251162,"No statistically significant differences were found between treatment groups at baseline (age, Wang Score, atopic history, smoking exposure).","[{'ForeName': 'Raphaelle', 'Initials': 'R', 'LastName': 'Jaquet-Pilloud', 'Affiliation': 'Department of Medical and Surgical Pediatrics, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Marie-Elise', 'Initials': 'ME', 'LastName': 'Verga', 'Affiliation': 'Department of Medical and Surgical Pediatrics, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Russo', 'Affiliation': 'Pediatrics & Neonatal Medicine Department Hospital, Sion, Valais, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gehri', 'Affiliation': 'Department of Medical and Surgical Pediatrics, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pauchard', 'Affiliation': 'Department of Medical and Surgical Pediatrics, University Hospital of Lausanne, Lausanne, Switzerland Jean-Yves.Pauchard@chuv.ch.'}]",Archives of disease in childhood,['10.1136/archdischild-2019-317160']
1487,16941885,[Immunological and microbiological aspects of low intensity laser effect on the factors of local immunity of the reproductive tract in women with chlamydia infection].,"Assessment of immunological and microbiological efficacy of Chlamydia cervicitis management was made by a complex method with a low intensity laser. The total number of leukocytes, percentage of viable cells and the number of neutrophils were detected in cervical secrets. Functional status of neutrophils was studied by a content of lysosomes on the ground of spontaneous and induced by latex HCT-reducing capacity, phagocytic activity. A system of cytokines was studied by interleukine level (IL-1 alpha, IL-1 beta, TNF-alpha, IL-8) and IFN-gamma content in cervical mucus. Positive clinical effect of the local use of the low intensity laser for Chlamydia cervicitis treatment was accompanied by positive changes in immunological indices of cervical secret, normal concentration of cytokines in cervical secret, restoration of the number and functions of neutrophils. Local use of the low intensity laser contributed to decreased number of opportunistic pathogenic microorganisms and their associations, and restored local flora.",2006,"Local use of the low intensity laser contributed to decreased number of opportunistic pathogenic microorganisms and their associations, and restored local flora.",['women with chlamydia infection'],['low intensity laser'],"['interleukine level (IL-1 alpha, IL-1 beta, TNF-alpha, IL-8) and IFN-gamma content in cervical mucus', 'number of opportunistic pathogenic microorganisms', 'immunological indices of cervical secret, normal concentration of cytokines in cervical secret, restoration of the number and functions of neutrophils', 'total number of leukocytes, percentage of viable cells and the number of neutrophils']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008149', 'cui_str': 'Chlamydia Infections'}]","[{'cui': 'C3873737', 'cui_str': 'Low-intensity laser (physical object)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600251', 'cui_str': 'Hematopoietin-1'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0007872', 'cui_str': 'Cervical Mucus'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1277200', 'cui_str': 'Normal concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",,0.0609379,"Local use of the low intensity laser contributed to decreased number of opportunistic pathogenic microorganisms and their associations, and restored local flora.","[{'ForeName': 'I I', 'Initials': 'II', 'LastName': 'Dolgushin', 'Affiliation': ''}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Gizinger', 'Affiliation': ''}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Telesheva', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1488,16438370,[Characteristics of the immune status in specific and nonspecific prophylaxis of influenza in elderly persons].,"The results of the comparative analysis of the immunological effectiveness of the anti-influenza vaccine Vaxigrip, the inferferon inductor Arbidol and their combination in 125 elderly persons are presented. In the process of investigations the immunomodulating activity of the preparations under study was noted; this activity was manifested by the increase of the absolute and relative number of cells, carrying markers CD3+, CD4+ and CD16+, but not CD8+, CD19+ and CD25+, the normalization of the immunoregulatory index and the stimulation of the phagocytic function in the absence of essential influence on the level of HLA-DR+ expression and the concentration of immunoglobulins of the main classes. An increase in the frequency of seroconversions and the multiplicity of growth in the titers of specific antibodies to influenza viruses A (H1N1 and H3N2) and B, most pronounced in persons immunized with the vaccine simulianeouslywith the injection of Arbidol, was established.",2005,"An increase in the frequency of seroconversions and the multiplicity of growth in the titers of specific antibodies to influenza viruses A (H1N1 and H3N2) and B, most pronounced in persons immunized with the vaccine simulianeouslywith the injection of Arbidol, was established.","['elderly persons', '125 elderly persons']",['anti-influenza vaccine Vaxigrip'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1312593', 'cui_str': 'vaxigrip'}]",[],125.0,0.0188783,"An increase in the frequency of seroconversions and the multiplicity of growth in the titers of specific antibodies to influenza viruses A (H1N1 and H3N2) and B, most pronounced in persons immunized with the vaccine simulianeouslywith the injection of Arbidol, was established.","[{'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Semenenko', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': ""Sel'kova"", 'Affiliation': ''}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Gotvianskaia', 'Affiliation': ''}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Gaĭdarenko', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Polezhaeva', 'Affiliation': ''}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Evseeva', 'Affiliation': ''}, {'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Nikolaeva', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1489,31513531,Comparing the effects of cold compress and Xyla-p cream on hemodynamic changes in hemodialysis patients during venipuncture.,"Background The vital signs reflect the physiological state of patients in various clinical conditions. The purpose of this study was to compare the effects of cold compress and Xyla-P cream on hemodynamical changes during venipuncture in hemodialysis patients. Methods and Material In this clinical trial study, 50 patients under hemodialysis were selected by simple random sampling. The patients were then randomly assigned to either Xyla-P cream, cold compress or placebo groups. The vital signs (blood pressure and pulse) were measured upon two intermittent hemodialysis sessions before and after venipuncture. Data were analyzed using repeated measures analysis of variance. Results The mean alternation in systolic blood pressure was significantly different comparing the placebo and cold compress groups before and after intervention (p<0.001). However, the difference was not significant between the Xyla-P cream group and either placebo (p=0.402) or ice compress (p=0.698) groups. The difference of the mean diastolic blood pressure was significant comparing the placebo group with either the Xyla-P cream group (p=0.003) or cold compress group (p<0.001) before and after intervention. In addition, there was a significant difference in the mean number of heartbeats comparing the control group with either the Xyla-P cream group (p<0.001) or cold compress group (p<0.001) before and after the intervention. Conclusions Considering the beneficial effects of ice compress and the Xyla-P cream on reduction of cardiovascular parameters, it is recommended to use these methods in hemodialysis patients during venipuncture.",2019,The difference of the mean diastolic blood pressure was significant comparing the placebo group with either the Xyla-P cream group (p=0.003) or cold compress group (p<0.001) before and after intervention.,"['50 patients under hemodialysis were selected by simple random sampling', 'hemodialysis patients during venipuncture', 'hemodialysis patients']","['Xyla-P cream,\xa0cold compress or placebo', 'Xyla-P cream', 'placebo', 'cold compress and Xyla-p cream', 'cold\xa0compress and Xyla-P cream']","['hemodynamic changes', 'vital signs (blood pressure and pulse', 'hemodynamical changes', 'mean diastolic blood pressure', 'mean alternation in systolic blood pressure', 'mean number of heartbeats']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0919661', 'cui_str': 'Heart alternation'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",50.0,0.035888,The difference of the mean diastolic blood pressure was significant comparing the placebo group with either the Xyla-P cream group (p=0.003) or cold compress group (p<0.001) before and after intervention.,"[{'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Ghoreyshi', 'Affiliation': 'Shohada Hospital, Mashhad University of Medical Sciences, Quchan, Iran (Islamic Republic of).'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Amerian', 'Affiliation': 'Clinical Research Development Unit, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran (Islamic Republic of).'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Amanpour', 'Affiliation': 'Clinical Research Development Unit, Bahar Hospital, Shahroud University of Medical Sciences, Shahroud, Iran (Islamic Republic of).'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Randomized Controlled Trial Research Center, Shahroud University of Medical Sciences, 7th Sq., Shahroud, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0154']
1490,31248471,Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis.,"Background:  Safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadine hydrochloride and mometasone furoate, was established in three large, 2-week seasonal allergic rhinitis studies.  Objective:  To evaluate long-term (52 weeks) safety and efficacy of GSP301 in patients with perennial allergic rhinitis (PAR).  Methods:  In this randomized, double-blind, parallel-group study, 601 patients (ages ≥ 12 years) with PAR were randomized 4:1:1 to twice-daily GSP301 (olopatadine 665 μg and mometasone 25 μg [pH 3.7]) or two GSP301 vehicle formulations (placebo pH 3.7 or 7.0). Safety (primary end point) was monitored through adverse events (AE), laboratory assessments, vital signs, and physical examinations at weeks 30 and 52. The change from baseline in the average A.M. reflective Total Nasal Symptom Score (rTNSS) and instantaneous Total Nasal Symptom Score (iTNSS), Physician-assessed Nasal Symptom Scores (PNSS), and quality of life were assessed for GSP301 versus placebo pH 3.7 (p < 0.05 was considered statistically significant).  Results:  At week 52, treatment-emergent AEs (TEAE) occurred in 51.7, 41.4, and 53.5% of patients in the GSP301, placebo pH 3.7 and placebo 7.0 groups, respectively. No clinically meaningful differences were observed in TEAE incidences or other safety assessments across treatments. At weeks 6 and 30, GSP301 provided significant and clinically meaningful improvements in average rTNSS and iTNSS versus placebo pH 3.7 (p < 0.01, all comparisons). Similarly, at week 52, GSP301 provided significant and clinically meaningful improvements in rTNSS (least-squares mean difference -0.91 [95% confidence interval {CI}, -1.35 to -0.47]; p < 0.001), and iTNSS (least-squares mean difference -0.75 [95% CI, -1.17 to -0.33]; p < 0.001) versus placebo pH 3.7, with significant improvements in each individual symptom (p < 0.05, all comparisons). PNSS and quality of life were significantly improved versus placebo pH 3.7 at weeks 6 and 30 (p < 0.05, all comparisons), but these greater improvements did not reach statistical significance at week 52 (PNSS, p = 0.552; quality of life, p = 0.790).  Conclusion:  Twice-daily GSP301 was well tolerated and provided statistically significant and clinically meaningful improvements in PAR nasal symptoms versus placebo over 52 weeks and demonstrated a favorable safety profile and efficacy.Clinical trial NCT02709538, <ext-link xmlns:xlink=""http://www.w3.org/1999/xlink"" ext-link-type=""uri"" xlink:href=""http://www.clinicaltrials.gov"">www.clinicaltrials.gov</ext-link>.",2019,"At weeks 6 and 30, GSP301 provided significant and clinically meaningful improvementsin average rTNSS and iTNSS versus placebo pH 3.7 (p < 0.01, all comparisons).","['601 patients (ages greater than or equal to 12 years) with PAR', 'patients with perennial allergic rhinitis', 'three large, 2-week seasonal allergic rhinitis studies', 'patients with perennial allergic rhinitis (PAR']","['olopatadinehydrochloride and mometasone furoate', 'placebo', 'GSP301 (olopatadine 665 mcrograms and mometasone 25 micrograms [pH 3.7]) or two GSP301 vehicle formulations (placebo pH 3.7 or 7.0', 'olopatadine-mometasone combination nasal spray', 'GSP301 nasal spray', 'GSP301']","['rTNSS', 'PNSS and quality of life', 'favorable safety profile and efficacy', 'PAR nasal symptoms', 'average A.M. reflectiveTotal Nasal Symptom Score (rTNSS) and instantaneous Total Nasal Symptom Score (iTNSS), Physician-assessed Nasal Symptom Scores (PNSS), and quality of life', 'adverse events (AE), laboratoryassessments, vital signs, and physical examinations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035457', 'cui_str': 'Rhinitis, Allergic, Nonseasonal'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0527189', 'cui_str': 'olopatadine'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}]","[{'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}]",601.0,0.548178,"At weeks 6 and 30, GSP301 provided significant and clinically meaningful improvementsin average rTNSS and iTNSS versus placebo pH 3.7 (p < 0.01, all comparisons).","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Segall', 'Affiliation': 'From Clinical Research Atlanta, Stockbridge, Georgia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Prenner', 'Affiliation': 'Allergy Associates Medical Group, Inc, San Diego, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lumry', 'Affiliation': 'AARA Research Center, Dallas, Texas.'}, {'ForeName': 'Cynthia F', 'Initials': 'CF', 'LastName': 'Caracta', 'Affiliation': 'Glenmark Pharmaceuticals Inc, Paramus, New Jersey.'}, {'ForeName': 'Sudeesh K', 'Initials': 'SK', 'LastName': 'Tantry', 'Affiliation': 'Glenmark Pharmaceuticals Inc, Paramus, New Jersey.'}]",Allergy and asthma proceedings,['10.2500/aap.2019.40.4233']
1491,32071901,Age-Related Serum Thyroid-Stimulating Hormone Reference Range in Older Patients Treated with Levothyroxine: A Randomized Controlled Feasibility Trial (SORTED 1).,"Introduction


Serum thyroid-stimulating hormone (TSH) increases with age but target TSH is similar in younger and older hypothyroid patients on treatment. It is unknown if quality of life (QoL), hypothyroid symptoms and cardiovascular risk factors change in older hypothyroid patients treated to an age-appropriate reference range.
Objective


To assess if a higher target serum TSH of 4.01-8.0 mU/L is feasible in, and acceptable to, older treated hypothyroid patients.
Methods


A single-blind (participant) randomised controlled feasibility trial involving 48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4-4.0 mU/L) was conducted. Standard (0.4-4.0 mU/L) or higher (4.1-8.0 mU/L) TSH target (standard TSH [ST] or higher TSH [HT] groups) LT4 for 24 weeks was administered. The outcome measures evaluated were thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption in participants that completed the trial ( n  = 21/24 ST group,  n  = 19/24 HT group).
Results


At 24 weeks, in the ST and HT groups, respectively, median (interquartile range) serum TSH was 1.25 (0.76-1.72) and 5.50 (4.05-9.12) mU/L, mean (± SD) free thyroxine (FT4) was 19.4 ± 3.5 and 15.9 ± 2.4 pmol/L, and daily LT4 dose was 82.1 ± 26.4 and 59.2 ± 23.9 µg. There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed.
Conclusions


In hypothyroid patients aged ≥80 years on LT4 therapy for 24 weeks, there was no evidence that a higher target serum TSH was associated with an adverse impact on patient reported outcomes, cardiovascular risk factors or bone resorption marker over 24 weeks. Longer-term trials assessing morbidity and mortality outcomes and health-utility in this age group are feasible and should be performed.",2020,"There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed.
","['48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4-4.0 mU/L) was conducted', 'older treated hypothyroid patients', 'older hypothyroid patients treated to an age-appropriate reference range', 'hypothyroid patients aged ≥80 years on']","['LT4 therapy', 'Introduction\n\n\nSerum thyroid-stimulating hormone (TSH', 'Levothyroxine']","['serum TSH', 'thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption', 'cardiovascular risk factors or bone resorption marker', 'target serum TSH', 'median (interquartile range) serum TSH', 'morbidity and mortality outcomes and health-utility']","[{'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1277938', 'cui_str': 'Serum TSH measurement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086715', 'cui_str': 'Normal Range'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439342', 'cui_str': 'uU/mL'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",48.0,0.120906,"There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed.
","[{'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Razvi', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Ingoe', 'Affiliation': 'Department of Endocrinology, Gateshead Health NHS Foundation Trust, Gateshead, United Kingdom.'}, {'ForeName': 'Simon H', 'Initials': 'SH', 'LastName': 'Pearce', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, University of Sunderland, Sunderland, United Kingdom.'}]",European thyroid journal,['10.1159/000504047']
1492,16028524,[Evaluation of the influence of the bacterial vaccines Pneumo-23 and Act-HIB on the course of the chronic inflammatory process of the respiratory organs in children].,"The effectiveness and safety of vaccination of children having chronic inflammatory lung diseses with Pneumo-23 and Act-HIB were evaluated. The group under study included 38 children having chronic pneumonia, congenital defects of lung development, Kartagener's syndrome, mucoviscidosis; of these children, 25 were vaccinated with Pneumo-23 and 13--with Act-HIB. For comparison a group of 40 children with the same pathology, but not vaccinated, was used. A favorable course of the postvaccinal period was noted. Prior to vaccination Streptococcus pneumoniae in association with Haemophilus influenzae were isolated from all patients; in a year after vaccination with Pneumo-23 these microorganisms were isolated only in monoculture: S. pneumoniae in 3 out of 25 cases (88% elimination) and H. influenzae in 10 out of 25 cases (60% elimination).",2005,The effectiveness and safety of vaccination of children having chronic inflammatory lung diseses with Pneumo-23 and Act-HIB were evaluated.,"[""38 children having chronic pneumonia, congenital defects of lung development, Kartagener's syndrome, mucoviscidosis; of these children, 25 were vaccinated with Pneumo-23 and 13--with Act-HIB"", '40 children with the same pathology, but not vaccinated, was used', 'children', 'children having chronic inflammatory lung diseses with Pneumo-23 and Act-HIB']",['bacterial vaccines Pneumo-23 and Act-HIB'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4039254', 'cui_str': 'Chronic pneumonia'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0022521', 'cui_str': 'Siewert Syndrome'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C1608615', 'cui_str': 'Pneumo-23'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0004632', 'cui_str': 'Bacterin'}, {'cui': 'C1608615', 'cui_str': 'Pneumo-23'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}]",[],40.0,0.0192683,The effectiveness and safety of vaccination of children having chronic inflammatory lung diseses with Pneumo-23 and Act-HIB were evaluated.,"[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Ryzhov', 'Affiliation': ''}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Katosova', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kostinov', 'Affiliation': ''}, {'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Volkov', 'Affiliation': ''}, {'ForeName': 'O O', 'Initials': 'OO', 'LastName': 'Magarshak', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1493,32102058,Hypoxic Exercise Training to Improve Exercise Capacity in Obese Individuals.,"INTRODUCTION


Combining exercise training with hypoxic exposure has been recently proposed as a new therapeutic strategy to improve health status of obese individuals. Whether hypoxic exercise training (HET) provides greater benefits regarding body composition and cardiometabolic parameters than normoxic exercise training (NET) remains, however, unclear. We hypothesized that HET would induce greater improvement in exercise capacity and health status than NET in overweight and obese individuals.
METHODS


Twenty-three subjects were randomized into 8-wk HET (11 men and 1 woman; age, 52 ± 12 yr; body mass index, 31.2 ± 2.4 kg·m) or NET (eight men and three women; age, 56 ± 11 yr; body mass index, 31.8 ± 3.2 kg·m) programs (three sessions per week; constant-load cycling at 75% of maximal heart rate; target arterial oxygen saturation for HET 80%, FiO2 ~0.13, i.e., ~3700 m a.s.l.). Before and after the training programs, the following evaluations were performed: incremental maximal and submaximal cycling tests, measurements of pulse-wave velocity, endothelial function, fasting glucose, insulin and lipid profile, blood NO metabolites and oxidative stress, and determination of body composition by magnetic resonance imaging.
RESULTS


Peak oxygen consumption and maximal power output increased significantly after HET only (peak oxygen consumption HET + 10% ± 11% vs NET + 1% ± 10% and maximal power output HET + 11% ± 7% vs NET + 3% ± 10%, P < 0.05). Submaximal exercise responses improved similarly after HET and NET. Except diastolic blood pressure which decreased significantly after both HET and NET, no change in vascular function, metabolic status and body composition was observed after training. Hypoxic exercise training only increased nitrite and reduced superoxide dismutase concentrations.
CONCLUSIONS


Combining exercise training and hypoxic exposure may provide some additional benefits to standard NET for obese individual health status.",2020,"RESULTS


Peak oxygen consumption and maximal power output increased significantly after HET only (peak oxygen consumption HET + 10 ± 11% versus NET + 1 ± 10% and maximal power output HET + 11 ± 7% versus NET + 3 ± 10%, p < 0.05).","['obese individuals', 'overweight and obese individuals', 'Obese Individuals', 'Twenty-three subjects were randomized into 8-week HET (11 males and 1 female ; age: 52 ± 12 years ; BMI: 31.2 ± 2.4 kg·m) or NET (8 males and 3 females ; age: 56 ± 11 years ; BMI']","['Hypoxic Exercise Training', 'hypoxic exercise training (HET', 'normoxic exercise training (NET', 'HET']","['Submaximal exercise responses', 'Exercise Capacity', 'incremental maximal and submaximal cycling tests, measurements of pulse-wave velocity, endothelial function, fasting glucose, insulin and lipid profile, blood NO metabolites and oxidative stress, determination of body composition by magnetic resonance imaging', 'Except diastolic blood pressure', 'exercise capacity and health status', 'vascular function, metabolic status and body composition', 'Peak oxygen consumption and maximal power output', 'nitrite and reduced superoxide dismutase concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",23.0,0.0284828,"RESULTS


Peak oxygen consumption and maximal power output increased significantly after HET only (peak oxygen consumption HET + 10 ± 11% versus NET + 1 ± 10% and maximal power output HET + 11 ± 7% versus NET + 3 ± 10%, p < 0.05).","[{'ForeName': 'Samarmar', 'Initials': 'S', 'LastName': 'Chacaroun', 'Affiliation': 'Université Grenoble Alpes, Inserm, Grenoble Alpes University Hospital, Grenoble, FRANCE.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borowik', 'Affiliation': ''}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Vega-Escamilla Y Gonzalez', 'Affiliation': ''}, {'ForeName': 'StÉphane', 'Initials': 'S', 'LastName': 'Doutreleau', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Wuyam', 'Affiliation': ''}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Belaidi', 'Affiliation': ''}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': ''}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pepin', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Flore', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002322']
1494,16028530,[Effect of the treatment of relapsing bronchitis in children with combined interferon preparations applicated by different methods].,The clinico-immunological effect and significance of the rectal and inhalation methods of the application of recombinant IFN-alpha2 with complex immunoglobulin preparation (CIP) in the treatment of relapsing bronchitis in children have been determined. The determination of the levels of interferon activity in buccal secretions and in venous blood permits the objective evaluation of the immune responsiveness of the body and the treatment effect. The immunocorrecting action of the combined immunobiological preparation (recombinant IFN-alpha2 and CIP) is manifested by an increased level of endogenic interferon and the stimulation of phagocytic activity.,2005,The determination of the levels of interferon activity in buccal secretions and in venous blood permits the objective evaluation of the immune responsiveness of the body and the treatment effect.,"['relapsing bronchitis in children', 'children with combined']","['interferon preparations', 'combined immunobiological preparation (recombinant IFN-alpha2 and CIP', 'recombinant IFN-alpha2 with complex immunoglobulin preparation (CIP']",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]",[],,0.0490929,The determination of the levels of interferon activity in buccal secretions and in venous blood permits the objective evaluation of the immune responsiveness of the body and the treatment effect.,"[{'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Bashkina', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': ""Afanas'ev"", 'Affiliation': ''}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Aleshkin', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': ""Vorob'ev"", 'Affiliation': ''}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': ""Rubal'skiĭ"", 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Kokuev', 'Affiliation': ''}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Somova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1495,32433277,Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery.,"BACKGROUND


Prospective trials of enhanced recovery after spine surgery are lacking. We tested the hypothesis that an enhanced recovery pathway improves quality of recovery after one- to two-level lumbar fusion.
METHODS


A patient- and assessor-blinded trial of 56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed. The primary outcome was Quality of Recovery-40 score (40 to 200 points) at postoperative day 3. Twelve points defined the clinically important difference. Secondary outcomes included Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein).
RESULTS


The analysis included 25 enhanced recovery patients and 26 usual care patients. Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference. There were no significant differences in recovery scores at days 0 (175 ± 16 vs. 162 ± 22; P = 0.059), 1 (174 ± 18 vs. 164 ± 15; P = 0.050), 2 (174 ± 18 vs. 167 ± 17; P = 0.289), 14 (184 ± 13 vs. 180 ± 12; P = 0.500), and 56 (187 ± 14 vs. 190 ± 8; P = 0.801). In the enhanced recovery group, subscores on the Quality of Recovery-40 comfort dimension were higher (longitudinal mean score difference, 4; 95% CI, 1, 7; P = 0.008); time to oral intake (-3 h; 95% CI, -6, -0.5; P = 0.010); and duration of intravenous patient-controlled analgesia (-11 h; 95% CI, -19, -6; P < 0.001) were shorter; opioid consumption was lower at day 1 (-57 mg; 95% CI, -130, -5; P = 0.030) without adversely affecting pain scores (-2; 95% CI, -3, 0; P = 0.005); and C-reactive protein was lower at day 3 (6.1; 95% CI, 3.8, 15.7 vs. 15.9; 95% CI, 6.6, 19.7; P = 0.037).
CONCLUSIONS


Statistically significant gains in early recovery were achieved by an enhanced recovery pathway. However, significant clinical impact was not demonstrated.",2020,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"['56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed', '25 enhanced recovery patients and 26 usual care patients', 'patients undergoing one- or two-level lumbar spinal fusion', 'Lumbar Spine Fusion']",[],"['pain scores', 'time to oral intake', 'shorter; opioid consumption', 'Quality of Recovery-40 comfort dimension', 'Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein', 'quality of recovery', 'duration of intravenous patient-controlled analgesia', 'time to oral intake, duration of patient-controlled analgesia use, and day 1 opioid consumption', 'Quality of Recovery-40 score', 'Quality of Patient Recovery', 'recovery scores', 'C-reactive protein', 'Quality of Recovery-40 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}]",[],"[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",56.0,0.363217,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Soffin', 'Affiliation': 'From the Departments of Anesthesiology, Critical Care and Pain Management, (E.M.S., J.D.B., A.T., M.U., C.R.G., J.A.N., I.F.A., S.G.M.) Orthopedic Surgery (R.C.H., H.-J.K., F.P.C., F.J.S.) the Biostatistics Core (H.Z.), Hospital for Special Surgery, New York, New York; and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Beckman', 'Affiliation': ''}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tseng', 'Affiliation': ''}, {'ForeName': 'Haoyan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Russel C', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Urban', 'Affiliation': ''}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Guheen', 'Affiliation': ''}, {'ForeName': 'Han-Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Cammisa', 'Affiliation': ''}, {'ForeName': 'Jemiel A', 'Initials': 'JA', 'LastName': 'Nejim', 'Affiliation': ''}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Schwab', 'Affiliation': ''}, {'ForeName': 'Isabel F', 'Initials': 'IF', 'LastName': 'Armendi', 'Affiliation': ''}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Memtsoudis', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003346']
1496,32104959,Palatal augmentation prostheses in individuals treated for head and neck cancer: Effects on speech and oral transport.,"BACKGROUND


Negative side effects affecting articulation and oral transport are common after treatment for head and neck cancer (HNC). The aim of this study was to assess the effects on speech and patient-reported experience of palatal augmentation prostheses (PAP) in this patient group.
METHODS


Twenty consecutive patients who had received a PAP were included. We performed a blinded randomized listener assessment of recordings of the patients' speech with and without the PAP. Patient-reported experiences were collected from medical records.
RESULTS


The listener assessment showed that production of velar sounds improved significantly for 12 of 19 patients; 12 of 19 patients also reported easier or better speech with the PAP. All six patients treated for tongue cancer reported speech improvement. Seven of 20 patients reported better transport of food or saliva.
CONCLUSION


A PAP can help patients treated for HNC to more precisely articulated velar consonants and can benefit oral transport.",2020,The listener assessment showed that production of velar sounds improved significantly for 12 of 19 patients; 12 of 19 patients also reported easier or better speech with the PAP.,"['Twenty consecutive patients who had received a PAP were included', ""patients' speech with and without the PAP"", 'individuals treated for head and neck cancer', 'head and neck cancer (HNC']","['palatal augmentation prostheses (PAP', 'Palatal augmentation prostheses']","['speech improvement', 'better transport of food or saliva', 'production of velar sounds']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0033268'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}]",20.0,0.0418413,The listener assessment showed that production of velar sounds improved significantly for 12 of 19 patients; 12 of 19 patients also reported easier or better speech with the PAP.,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Löfhede', 'Affiliation': 'Department of Otorhinolaryngology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Wertsén', 'Affiliation': 'Clinic of Pedodontics and Special Dental Care, Sahlgrenska University Hospital, Mölndal, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Havstam', 'Affiliation': 'Department of Otorhinolaryngology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Head & neck,['10.1002/hed.26124']
1497,15636140,[Cycloferon--a new domestic preparation for the prophylaxis of influenza and other acute respiratory viral infections].,"The results of the placebo-controlled multicenter study of the epidemiological efficiency of the preparation Cycloferon for the prophylaxis of acute respiratory viral infections in children and adolescents are presented. A total of 16,000 children and adolescents were selected for the study. The epidemiological efficiency of the preparation manifested in 1.5- 2.9-fold decreased morbidity level with a protection index equal to 41 - 90%, was demonstrated.",2004,"The epidemiological efficiency of the preparation manifested in 1.5- 2.9-fold decreased morbidity level with a protection index equal to 41 - 90%, was demonstrated.","['16,000 children and adolescents were selected for the study', 'children and adolescents']","['Cycloferon--a new domestic preparation', 'preparation Cycloferon', 'placebo']",['morbidity level'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0908045', 'cui_str': 'cycloferon'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",16000.0,0.0230199,"The epidemiological efficiency of the preparation manifested in 1.5- 2.9-fold decreased morbidity level with a protection index equal to 41 - 90%, was demonstrated.","[{'ForeName': 'F I', 'Initials': 'FI', 'LastName': 'Ershov', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Kovalenko', 'Affiliation': ''}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Garashchenko', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': ""Sel'kova"", 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': ""Botvin'eva"", 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Zhekalov', 'Affiliation': ''}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Petlenko', 'Affiliation': ''}, {'ForeName': 'Iu K', 'Initials': 'IuK', 'LastName': ""Bol'bot"", 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Romantsov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1498,32073181,Challenging the Status Quo of Physician Attire in the Palliative Care Setting.,"BACKGROUND, AIM, AND HYPOTHESIS


This randomized controlled trial aimed to compare the impact of a physician's attire on the perceptions of patients with cancer of compassion, professionalism, and physician preference. Our hypothesis was that patients would perceive the physician with formal attire as more compassionate than the physician wearing casual attire.
MATERIALS AND METHODS


One hundred five adult follow-up patients with advanced cancer were randomized to watch two standardized, 3-minute video vignettes with the same script, depicting a routine physician-patient clinic encounter. Videos included a physician in formal attire with tie and buttoned-up white coat and casual attire without a tie or white coat. Actors, patients, and investigators were all blinded to the purpose and videos watched, respectively. After each video, patients completed validated questionnaires rating their perception of physician compassion, professionalism, and their overall preference for the physician.
RESULTS


There were no significant differences between formal and casual attire for compassion (median [interquartile range], 25 [10-31] vs. 20 [8-27]; p = .31) and professionalism (17 [13-21] vs. 18 [14-22]; p = .42). Thirty percent of patients preferred formal attire, 31% preferred casual attire, and 38% had no preference. Subgroup analysis did not show statistically significant differences among different cohorts of age, sex, marital status, and education level.
CONCLUSION


Doctors' attire did not affect the perceptions of patients with cancer of physician's level of compassion and professionalism, nor did it influence the patients' preference for their doctor or their trust and confidence in the doctor's ability to provide care. There is a need for more studies in this area of communications skills. Clinical trial identification number. NCT03168763 IMPLICATIONS FOR PRACTICE: The significance of physician attire as a means of nonverbal communication has not been well characterized. It is an important element to consider, as patient preferences vary geographically, are influenced by cultural beliefs, and may vary based on particular care settings. Previous studies consisted of nonblinded surveys and found increasing confidence in physicians wearing a professional white coat. Unfortunately, there are no randomized controlled trials, to the authors' knowledge, to confirm the survey findings. In this randomized, blinded clinical trial the researchers found that physician's attire did not affect patients' perception of the physician's level of compassion and professionalism. Attire also did not influence the patients' preferences for their doctor or their trust and confidence in the doctor's ability to provide care.",2020,Attire also did not influence the patients' preferences for their doctor or their trust and confidence in the doctor's ability to provide care.,"['physicians wearing a professional white coat', 'One hundred five adult follow-up patients with advanced cancer', 'patients with cancer of compassion, professionalism, and physician preference']","[""physician's attire"", 'physician in formal attire with tie and buttoned-up white coat and casual attire without a tie or white coat']",['formal and casual attire for compassion'],"[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0815219', 'cui_str': 'Professionalism'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}]",105.0,0.0534579,Attire also did not influence the patients' preferences for their doctor or their trust and confidence in the doctor's ability to provide care.,"[{'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kimberson', 'Initials': 'K', 'LastName': 'Tanco', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Minjeong', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0568']
1499,15881949,"[Clinical and immunological effect produced by vaccination with ""Pneumo 23"" of children with atopic bronchial asthma].","A total of 45 children aged 4-16 years with atopic bronchial asthma of different severity level-resulted from a past case of outhospital pneumonia, received vaccine ""Pneumo 23"" (""Aventis Pasteur"", France). The vaccine was found to be well tolerated, no cases of the exacerbation of the atopic process were registered. A reliable Increased level of specific antibodies to the mixture of polysaccharides, contained in the vaccine ""Pneumo 23"", was found to occur. The tendency towards decreased level of serum IgE was established.",2005,"A reliable Increased level of specific antibodies to the mixture of polysaccharides, contained in the vaccine ""Pneumo 23"", was found to occur.","['children with atopic bronchial asthma', '45 children aged 4-16 years with atopic bronchial asthma of different severity level-resulted from a past case of outhospital pneumonia, received']","['vaccine ""Pneumo 23"" (""Aventis Pasteur"", France']",['level of serum IgE'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1608615', 'cui_str': 'Pneumo-23'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}]",45.0,0.0233058,"A reliable Increased level of specific antibodies to the mixture of polysaccharides, contained in the vaccine ""Pneumo 23"", was found to occur.","[{'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Markelova', 'Affiliation': ''}, {'ForeName': 'Ia S', 'Initials': 'IaS', 'LastName': 'Gushchina', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kostinov', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Zhuravleva', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1500,15636137,[Naso-subcutaneous application of the polycomponent vaccine VP-4 for the treatment of patients with bronchial asthma and chronic obstructive bronchitis].,"Bacterial polycomponent vaccine (VP-4) earlier developed at the Mechnikov Research Institute for Vaccines and Sera on the basis of antigenic complexes of Klebsiella pneumoniae, Proteus vulgaris, Escherichia coli, Staphylococcus aureus was used within the program of clinical trials, for the treatment of 30 patients aged 16-59 years with the atopic and mixed form of bronchial asthma and chronic obstructive bronchitis by the combined naso-subcutaneous application. A good therapeutic effect produced by the vaccine was registered in 83.3% of the patients. It was manifested by a lower frequency of acute respiratory diseases and bronchopulmonary diseases as well as decreased need in antibiotic therapy. In the group of comparison a good effect was noted in 40% of the patients during 6 months of observation (statistically significant difference). Side effects caused by the administration of the vaccine were transitory, had mainly local character and disappeared without any treatment. In 1 patient the development of anaphylactic shock was observed. The positive effect of vaccine VP-4 could be attributed to the improved indices of cell-mediated immunity, an increased synthesis of alpha- and gamma-interferon, a droped level of IgE and specific IgG antibodies to Staphylococcus sp., Klebsiella sp., Proteus sp., Escherichia coli.",2004,It was manifested by a lower frequency of acute respiratory diseases and bronchopulmonary diseases as well as decreased need in antibiotic therapy.,"['30 patients aged 16-59 years with the atopic and mixed form of bronchial asthma and chronic obstructive bronchitis by the combined naso-subcutaneous application', 'patients with bronchial asthma and chronic obstructive bronchitis']","['polycomponent vaccine VP-4', 'Bacterial polycomponent vaccine (VP-4']","['Side effects', 'anaphylactic shock']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0155874', 'cui_str': 'Chronic obstructive bronchitis (disorder)'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002792', 'cui_str': 'Anaphylactic Reaction'}]",30.0,0.0319485,It was manifested by a lower frequency of acute respiratory diseases and bronchopulmonary diseases as well as decreased need in antibiotic therapy.,"[{'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Antonova', 'Affiliation': ''}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Markova', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Kurbatova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1501,15554315,"[Evaluation of the reactogenicity and immunogenic potency of combined vaccine ""Bubo-Kok"" in the immunization of children against diphtheria, tetanus, pertussis and viral hepatitis B].","Combined vaccine ""Bubo-Kok"" is characterized by safety and high immunological activity. The number of postvaccinal reactions in children aged 1 and 2 years, immunized with vaccine ""Bubo-Kok"", was not statistically different from those in groups of children immunized with adsorbed DPT vaccine, as well with such vaccine in combination with vaccine against hepatitis B. After the completion of the primary course of immunization 100% of children had protective antibody titers against diphtheria, tetanus and hepatitis B. Antibody titers against pertussis, equal to or exceeding protective titers, were found in more than 70% of immunized children. The immunogenic potency of vaccine ""Bubo-Kok"" with respect to all its components was not inferior to that of adsorbed DPT vaccine and vaccine against hepatitis B, when introduced simultaneously in different areas of the body. Vaccine ""Bubo-Kok"" successfully passed state trials and was recommended for registration.",2004,"The immunogenic potency of vaccine ""Bubo-Kok"" with respect to all its components was not inferior to that of adsorbed DPT vaccine and vaccine against hepatitis B, when introduced simultaneously in different areas of the body.","['children against diphtheria, tetanus, pertussis and viral hepatitis B']","['combined vaccine ""Bubo-Kok', 'Combined vaccine ""Bubo-Kok', 'adsorbed DPT vaccine']","['number of postvaccinal reactions', 'protective antibody titers against diphtheria, tetanus and hepatitis B. Antibody titers against pertussis, equal to or exceeding protective titers']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0221382', 'cui_str': 'Bubo (morphologic abnormality)'}, {'cui': 'C1277100', 'cui_str': 'DPT Vaccine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.0381354,"The immunogenic potency of vaccine ""Bubo-Kok"" with respect to all its components was not inferior to that of adsorbed DPT vaccine and vaccine against hepatitis B, when introduced simultaneously in different areas of the body.","[{'ForeName': 'I V', 'Initials': 'IV', 'LastName': ""Fel'dblium"", 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Nikolaeva', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': ""Kuz'ianin"", 'Affiliation': ''}, {'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Borisova', 'Affiliation': ''}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': ""Mel'nikov"", 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Chuprinina', 'Affiliation': ''}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Perelygina', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Shalunova', 'Affiliation': ''}, {'ForeName': 'V D', 'Initials': 'VD', 'LastName': 'Semenova', 'Affiliation': ''}, {'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Griaznova', 'Affiliation': ''}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Pushkareva', 'Affiliation': ''}, {'ForeName': 'A Iu', 'Initials': 'AIu', 'LastName': 'Uvitskiĭ', 'Affiliation': ''}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Alekseeva', 'Affiliation': ''}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Konopleva', 'Affiliation': ''}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Budanov', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Iakovleva', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1502,15554316,[Total immunization of children against influenza decreases morbidity in a number of diseases among elderly persons during influenza epidemic].,"Immunization of children aged 3-6 years in kindergartens and school children aged 7-17 years against influenza with inactivated influenza vaccine was carried out in two districts of the Moscow region. The comparison of morbidity in influenza-like diseases among the immunized children with that among nonimmunized children in control districts revealed that the effectiveness of immunization was 60.9% in kindergartens and 68.8% in schools. The analysis of morbidity in a number of diseases among 158,451 elderly persons not immunized against influenza demonstrated that, in comparison with the control districts, in those districts where mass immunization of children was carried out morbidity in influenza-like diseases among elderly persons was 3.4 times lower and, out of other 10 diseases under study, morbidity in 8 diseases was 1.5-2.6 times lower. As indicated by the data obtained in this study, total anti-influenza immunization of children in organized groups not only essentially decreased influenza morbidity among children, but also greatly decreased morbidity in influenza and a number of diseases, appearing as complications of influenza infection, among nonimmunized elderly persons during influenza epidemic.",2004,The comparison of morbidity in influenza-like diseases among the immunized children with that among nonimmunized children in control districts revealed that the effectiveness of immunization was 60.9% in kindergartens and 68.8% in schools.,"['158,451 elderly persons', 'elderly persons during influenza epidemic', 'children aged 3-6 years in kindergartens and school children aged 7-17 years against influenza with']",['inactivated influenza vaccine'],"['effectiveness of immunization', 'influenza morbidity']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",158451.0,0.0144925,The comparison of morbidity in influenza-like diseases among the immunized children with that among nonimmunized children in control districts revealed that the effectiveness of immunization was 60.9% in kindergartens and 68.8% in schools.,"[{'ForeName': 'Iu Z', 'Initials': 'IuZ', 'LastName': 'Gendon', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Kaira', 'Affiliation': ''}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': ""El'shina"", 'Affiliation': ''}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Akhmadulina', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1503,15773400,[Immunoprophylaxis of poliomyelitis in Ukraine with the use of inactivated vaccine].,"In connection with the cessation of the circulation of ""wild"" poliovirus on the territory of the European region, including Ukraine, the strategy of the vaccinal prophylaxis of poliomyelitis is reviewed. Its main aims are the creation of a high level of the specific protection of the population, the prophylaxis of vaccine-associated paralytic poliomyelitis and a decrease in the intensity of the circulation vaccine polioviruses. These aims may be achieved only by the inclusion of vaccinations with inactivated poliomyelitis vaccine (IPV) into the immunization schedule. IPV ""Imovax Polio"" produced by the firm ""Aventis Pasteur"" (France) has been shown to have low reactogenicity and high effectiveness, especially with respect to type 3 poliovirus, under the conditions of Ukraine. On the basis of our studies all children, starting from the age of 3 months, are recommended to be vaccinated first with two injections of IPV, followed by further immunization with oral vaccine.",2005,"In connection with the cessation of the circulation of ""wild"" poliovirus on the territory of the European region, including Ukraine, the strategy of the vaccinal prophylaxis of poliomyelitis is reviewed.",[],"['inactivated vaccine', 'inactivated poliomyelitis vaccine (IPV']",[],[],"[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0718003', 'cui_str': 'Poliovirus Vaccine, Inactivated'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]",[],,0.0228574,"In connection with the cessation of the circulation of ""wild"" poliovirus on the territory of the European region, including Ukraine, the strategy of the vaccinal prophylaxis of poliomyelitis is reviewed.","[{'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Frolov', 'Affiliation': ''}, {'ForeName': 'O P', 'Initials': 'OP', 'LastName': ""Sel'nikova"", 'Affiliation': ''}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Zadorozhnaia', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Moiseeva', 'Affiliation': ''}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Demchishina', 'Affiliation': ''}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Bondarenko', 'Affiliation': ''}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Zubkova', 'Affiliation': ''}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Doan', 'Affiliation': ''}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Buraia', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1504,31531996,Short-Term Creatine Supplementation May Alleviate the Malnutrition-Inflammation Score and Lean Body Mass Loss in Hemodialysis Patients: A Pilot Randomized Placebo-Controlled Trial.,"BACKGROUND


Creatine supplementation has been proposed to alleviate muscle loss in various populations, but has not been investigated in hemodialysis (HD) patients. Thus, our objective was to evaluate whether creatine supplementation could attenuate the loss of lean body mass (LBM) and malnutrition-inflammation score (MIS) in HD patients.
METHODS


A randomized, placebo-controlled, double blind, parallel-design study included HD patients, of both sexes, aged 18-59 years. The patients were allocated to a Placebo Group (PG; n = 15; received maltodextrin, 1st week: 40 g/day and 2nd-4th weeks: 10 g/day) and a Creatine Group (CG; n = 15; received creatine plus maltodextrin, 1st week: 20 g/day of creatine plus 20 g/day of maltodextrin and 2nd-4th weeks: 5 g/day of creatine plus 5 g/day of maltodextrin). Pre and post the intervention, patients were evaluated for food intake, MIS, body composition and biochemical parameters.
RESULTS


CG group attenuated the MIS (Pre: 5.57 ± 0.72 vs. Post: 3.85 ± 0.47 score, P = 0.003) compared with PG (Pre: 5.71 ± 0.97 vs. Post: 5.36 ± 0.95 score, P = 0.317) (supplement × time P = 0.017, effect size: 0.964). The change of LBM was greater in CG than in PG (CG: Δ0.95 vs PG: Δ0.13 kg). At post-intervention, 28.6% of PG patients presented LBM loss and 71.4% remain stable. In contrast, 14.4% of CG patients had LBM loss, 42.8% remain stable and 42.8% gained. Food intake and quality of life did not change. CG increased the BMI and gait speed in post-compared to pre-moment, but no difference among the groups.
CONCLUSION


In HD patients, four weeks of creatine supplementation may alleviate the MIS as well as attenuate the LBM loss compared to placebo.",2020,"RESULTS


CG group attenuated the MIS (Pre: 5.57 ± 0.72 vs. Post: 3.85 ± 0.47 score, P = 0.003) compared with PG (Pre: 5.71 ± 0.97 vs. Post: 5.36 ± 0.95 score, P = 0.317) (supplement × time P = 0.017, effect size: 0.964).","['Hemodialysis Patients', 'HD patients, of both sexes, aged 18-59 years', 'hemodialysis (HD) patients', 'HD patients']","['Placebo', 'Short-Term Creatine Supplementation', 'creatine supplementation', 'Creatine Group (CG; n\xa0=\xa015; received creatine plus maltodextrin, 1st week: 20\xa0g/day of creatine plus 20\xa0g/day of maltodextrin and 2nd-4th weeks: 5\xa0g/day of creatine plus 5\xa0g/day of maltodextrin', 'placebo', 'Creatine supplementation', 'maltodextrin']","['Malnutrition-Inflammation Score and Lean Body Mass Loss', 'food intake, MIS, body composition and biochemical parameters', 'Food intake and quality of life', 'BMI and gait speed', 'change of LBM', 'LBM loss', 'loss of lean body mass (LBM) and malnutrition-inflammation score (MIS']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439417', 'cui_str': 'g/day'}]","[{'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.486673,"RESULTS


CG group attenuated the MIS (Pre: 5.57 ± 0.72 vs. Post: 3.85 ± 0.47 score, P = 0.003) compared with PG (Pre: 5.71 ± 0.97 vs. Post: 5.36 ± 0.95 score, P = 0.317) (supplement × time P = 0.017, effect size: 0.964).","[{'ForeName': 'Ana Clara B', 'Initials': 'ACB', 'LastName': 'Marini', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'Reika D', 'Initials': 'RD', 'LastName': 'Motobu', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'Ana T V', 'Initials': 'ATV', 'LastName': 'Freitas', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Pichard', 'Affiliation': 'Clinical Nutrition, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Laviano', 'Affiliation': ""Department of Clinical Medicine, Sapienza University, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Gustavo Duarte', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1707']
1505,31504699,"Prevotella Abundance Predicts Weight Loss Success in Healthy, Overweight Adults Consuming a Whole-Grain Diet Ad Libitum: A Post Hoc Analysis of a 6-Wk Randomized Controlled Trial.","BACKGROUND


The key to effective weight loss may be to match diet and gut microbes, since recent studies have found that subjects with high Prevotella abundances in their gut microbiota lose more weight on diets rich in fiber than subjects with low Prevotella abundances.
OBJECTIVES


We reanalyzed a 6-wk, parallel, randomized trial to investigate difference in body weight changes when participants, stratified by fecal microbiota composition, consumed ad libitum a whole-grain (WG) or a refined-wheat (RW) diet.
METHODS


We stratified 46 (19 men, 27 women; ages 30-65 y) healthy, overweight adults by baseline Prevotella-to-Bacteroides ratios and Prevotella abundances. Subjects with no Prevotella were analyzed separately (n = 24). Compared with the RW diet (mean = 221 g/d), the WG diet (mean = 228 g/d) had a higher fiber content (33 g/d compared with 23 g/d). Linear mixed models and correlations were applied to link 6-wk changes in body weights and metabolic and microbiota markers, according to Prevotella groups and diets.
RESULTS


The Prevotella abundances correlated inversely with weight changes (r = -0.34; P = 0.043). Consequently, subjects with high Prevotella abundances (n = 15) spontaneously lost 1.80 kg (95% CI: -3.23, -0.37 kg; P = 0.013) more on the WG diet than on the RW diet, whereas those with low Prevotella abundances (n = 31) were weight stable (-0.22 kg; 95% CI: -1.40, 0.96 kg; P = 0.72). Thus, the mean difference between the Prevotella groups was 2.02 kg (95% CI: -3.87, -0.17 kg; P = 0.032). Subjects with no Prevotella lost 1.59 kg (95% CI: -2.65, -0.52 kg; P = 0.004) more on the WG diet than on the RW diet. No 6-wk changes in appetite sensations, glucose metabolisms, or fecal SCFAs were associated with the Prevotella groups.
CONCLUSIONS


Healthy, overweight adults with high Prevotella abundances lost more weight than subjects with low Prevotella abundances when consuming a diet rich in WG and fiber ad libitum for 6 wk. This further supports enterotypes as a potential biomarker in personalized nutrition for obesity management. This t rial was registered at clinicaltrials.gov as NCT02358122.",2019,"No 6-wk changes in appetite sensations, glucose metabolisms, or fecal SCFAs were associated with the Prevotella groups.
","['Healthy, Overweight Adults', 'Healthy, overweight adults with high Prevotella abundances lost more weight than subjects with low Prevotella abundances', 'We stratified 46 (19 men, 27 women; ages 30-65 y) healthy, overweight adults by baseline Prevotella-to-Bacteroides ratios and Prevotella abundances', 'Subjects with no Prevotella were analyzed separately (n\xa0=\xa024']",['ad libitum a whole-grain (WG) or a refined-wheat (RW) diet'],"['weight stable', 'body weight changes', 'appetite sensations, glucose metabolisms, or fecal SCFAs', 'body weights and metabolic and microbiota markers', 'weight changes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",27.0,0.0566069,"No 6-wk changes in appetite sensations, glucose metabolisms, or fecal SCFAs were associated with the Prevotella groups.
","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Vuholm', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik M', 'Initials': 'HM', 'LastName': 'Roager', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Nielsen', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Krych', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kristensen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}]",The Journal of nutrition,['10.1093/jn/nxz198']
1506,32103441,Instability in End-of-Life Care Preference Among Heart Failure Patients: Secondary Analysis of a Randomized Controlled Trial in Singapore.,"BACKGROUND


Efforts to improve quality of end-of-life (EOL) care are increasingly focused on eliciting patients' EOL preference through advance care planning (ACP). However, if patients' EOL preference changes over time and their ACP documents are not updated, these documents may no longer be valid at the time EOL decisions are made.
OBJECTIVES


To assess extent and correlates of changes in stated preference for aggressive EOL care over time.
DESIGN


Secondary analysis of data from a randomized controlled trial of a formal ACP program versus usual care in Singapore.
PATIENTS


Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4 months for up to 2 years to assess their preference for EOL care. Analytic sample included 200 patients interviewed at least twice.
RESULTS


Nearly two thirds (64%) of patients changed their preferred type of EOL care at least once. Proportion of patients changing their stated preference for type of EOL care increased with time and the change was not unidirectional. Patients who understood their prognosis correctly were less likely to change their preference from non-aggressive to aggressive EOL care (OR 0.66, p value 0.07) or to prefer aggressive EOL care (OR 0.53; p value 0.001). On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
CONCLUSION


The study provides evidence of instability in HF patients' stated EOL care preference. This undermines the value of an ACP document recorded months before EOL decisions are made unless a strategy exists for easily updating this preference.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02299180.",2020,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","['Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4\xa0months for up to 2\xa0years to assess their preference for EOL care', 'Heart Failure Patients', '200 patients interviewed at least twice']",['formal ACP program versus usual care in Singapore'],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]",[],282.0,0.0539074,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","[{'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Malhotra', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. chetna.malhotra@duke-nus.edu.sg.'}, {'ForeName': 'Meibo', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre Singapore, 5 Hospital Drive, Singapore, 169609, Singapore.'}, {'ForeName': 'Fazlur Rehman', 'Initials': 'FR', 'LastName': 'Jaufeerally', 'Affiliation': 'Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Filipinas G', 'Initials': 'FG', 'LastName': 'Bundoc', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}]",Journal of general internal medicine,['10.1007/s11606-020-05740-2']
1507,31500524,Cerebrovascular effects of endothelin-1 investigated using high-resolution magnetic resonance imaging in healthy volunteers.,"Endothelin-1 (ET-1) is a highly potent vasoconstrictor peptide released from vascular endothelium. ET-1 plays a major role in cerebrovascular disorders and likely worsens the outcome of acute ischaemic stroke and aneurismal subarachnoid haemorrhage through vasoconstriction and cerebral blood flow (CBF) reduction. Disorders that increase the risk of stroke, including hypertension, diabetes mellitus, and acute myocardial infarction, are associated with increased plasma levels of ET-1. The in vivo human cerebrovascular effects of systemic ET-1 infusion have not previously been investigated. In a two-way crossover, randomized, double-blind design, we used advanced 3 tesla MRI methods to investigate the effects of high-dose intravenous ET-1 on intra- and extracranial artery circumferences, global and regional CBF, and cerebral metabolic rate of oxygen (CMRO 2 ) in 14 healthy volunteers. Following ET-1 infusion, we observed a 14% increase of mean arterial blood pressure, a 5% decrease of middle cerebral artery (MCA) circumference, but no effects on extracerebral arteries and no effects on CBF or CMRO 2 . Collectively, the findings indicate MCA constriction secondarily to blood pressure increase and not due to a direct vasoconstrictor effect of ET-1. We suggest that, as opposed to ET-1 in the subarachnoid space, intravascular ET-1 does not exert direct cerebrovascular effects in humans.",2020,"Following ET-1 infusion, we observed a 14% increase of mean arterial blood pressure, a 5% decrease of middle cerebral artery (MCA) circumference, but no effects on extracerebral arteries and no effects on CBF or CMRO 2 .","['14 healthy volunteers', 'healthy volunteers']","['Endothelin-1 (ET-1', 'endothelin-1 investigated using high-resolution magnetic resonance imaging']","['blood pressure increase', 'intra- and extracranial artery circumferences, global and regional CBF, and cerebral metabolic rate of oxygen (CMRO 2 ', 'risk of stroke, including hypertension, diabetes mellitus, and acute myocardial infarction', 'mean arterial blood pressure', 'middle cerebral artery (MCA) circumference']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}]",14.0,0.171039,"Following ET-1 infusion, we observed a 14% increase of mean arterial blood pressure, a 5% decrease of middle cerebral artery (MCA) circumference, but no effects on extracerebral arteries and no effects on CBF or CMRO 2 .","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hougaard', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Kristian A', 'Initials': 'KA', 'LastName': 'Haanes', 'Affiliation': 'Department of Clinical Experimental Research, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Lindberg', 'Affiliation': 'Department of Clinical Physiology, Functional Imaging Unit, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Clinical Physiology, Functional Imaging Unit, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, USA.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Kruse', 'Affiliation': 'Department of Clinical Experimental Research, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Ayata', 'Affiliation': 'Stroke Service, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, USA.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X19874295']
1508,31504831,The Presence and Persistence of Unrealistic Expectations in Patients Undergoing Nerve Surgery.,"BACKGROUND


Unrealistic expectations of the outcomes of peripheral nerve surgery reduce patient satisfaction. Most clinicians can recall patients with unrealistic expectations despite verbal preoperative education.
OBJECTIVE


To assess patients' baseline level of understanding regarding nerve surgery and appropriate expectations. Additionally, we tested the effect of a written, preoperative educational handout on the patients' retention of knowledge.
METHODS


This cross-sectional survey recruited patients scheduled to undergo peripheral nerve surgery at a single institution in 2016 to 2017. During the preoperative visit, a specialized nurse practitioner reviewed perioperative protocols, risks and benefits of the surgery, and postoperative care. Patients immediately completed a survey to assess their preoperative understanding of the verbally reviewed information. During the same visit, an additional written handout was given to patients in a randomized fashion. At their first postoperative visit, all patients completed the survey again.
RESULTS


A total of 60 patients (mean age 52 yr) were enrolled of which 62% were male. Immediately following verbal instruction, 31% of patients had erroneous (unrealistic) expectations regarding pain, 30% had erroneous expectations regarding postoperative motor outcome, and 41% had erroneous expectations regarding the timing of postoperative recovery. There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
CONCLUSION


Patients undergoing peripheral nerve procedures demonstrated a high baseline level of unrealistic expectations despite standard in-person verbal counseling by specialty providers. A written handout did not have clear benefit in the retention of preoperative surgical teaching. Further investigation into more effective preoperative patient counseling is needed.",2020,"There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
","['Patients Undergoing Nerve Surgery', 'patients scheduled to undergo peripheral nerve surgery at a single institution in 2016 to 2017', '60 patients (mean age 52 yr) were enrolled of which 62% were male']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],[],,0.067368,"There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kirsch', 'Affiliation': 'School of Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brandon W', 'Initials': 'BW', 'LastName': 'Smith', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kate W C', 'Initials': 'KWC', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Sravanthi', 'Initials': 'S', 'LastName': 'Koduri', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lynda J S', 'Initials': 'LJS', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}]",Neurosurgery,['10.1093/neuros/nyz335']
1509,31504868,Acute Experimental Pain Responses in Methadone- and Buprenorphine/Naloxone-Maintained Patients Administered Additional Opioid or Gabapentin: A Double-Blind Crossover Pilot Study.,"OBJECTIVE


The study objective was to identify the analgesic efficacy of three different pharmacological strategies in patients receiving methadone or buprenorphine as opioid agonist treatment (OAT). The three pharmacological approaches, a) increasing maintenance methadone/buprenorphine dose by 30%, b) adding oxycodone, or c) adding a single dose of gabapentin, were compared with a control condition of the participant's usual OAT dose.
DESIGN


A randomized, controlled, double-blinded, double-dummy, within-subject crossover study.
SUBJECTS


Nine participants on stable doses of methadone and eight participants on stable doses of buprenorphine were recruited.
SETTING


An outpatient opioid treatment clinic in inner city Sydney, Australia.
METHODS


The cold pressor tolerance test was used to examine experimental pain threshold and tolerance. Ratings of subjective drug effects and safety measures (physiological and cognitive) were assessed.
RESULTS


There was no difference in the primary outcome measures of pain thresholds or tolerance between the conditions examined. Interindividual variability was evident. Differences in some subjective measures were identified, including lower pain recall, lower ""bad effects,"" and higher global satisfaction in the additional methadone condition. In the buprenorphine arm, increased drug liking and ""bad effects"" were detected with oxycodone administration, while increased subjective intoxication was identified with gabapentin.
CONCLUSIONS


There was no evidence of an objective improvement in analgesia with any condition compared with control. Further research is required to optimize pain management strategies in this population.",2020,"Differences in some subjective measures were identified, including lower pain recall, lower ""bad effects,"" and higher global satisfaction in the additional methadone condition.","['patients receiving methadone or buprenorphine as opioid agonist treatment (OAT', 'Nine participants on stable doses of methadone and eight participants on stable doses of', 'An outpatient opioid treatment clinic in inner city Sydney, Australia']","['methadone/buprenorphine', 'oxycodone, or c) adding a single dose of gabapentin', 'Methadone- and Buprenorphine/Naloxone-Maintained Patients Administered Additional Opioid or Gabapentin', 'buprenorphine', 'oxycodone']","['analgesic efficacy', 'Ratings of subjective drug effects and safety measures (physiological and cognitive', 'Acute Experimental Pain Responses', 'lower pain recall, lower ""bad effects,"" and higher global satisfaction', 'pain thresholds or tolerance', 'drug liking and ""bad effects', 'Interindividual variability', 'subjective intoxication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}]",9.0,0.341347,"Differences in some subjective measures were identified, including lower pain recall, lower ""bad effects,"" and higher global satisfaction in the additional methadone condition.","[{'ForeName': 'Bridin Patricia', 'Initials': 'BP', 'LastName': 'Murnion', 'Affiliation': 'Drug and Alcohol Services, Central Coast Local Health District, Hamlyn Terrace, Australia.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Apo', 'Initials': 'A', 'LastName': 'Demirkol', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Hayes', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz178']
1510,32135010,A gene-diet interaction-based score predicts response to dietary fat in the Women's Health Initiative.,"BACKGROUND


Although diet response prediction for cardiometabolic risk factors (CRFs) has been demonstrated using single genetic variants and main-effect genetic risk scores, little investigation has gone into the development of genome-wide diet response scores.
OBJECTIVE


We sought to leverage the multistudy setup of the Women's Health Initiative cohort to generate and test genetic scores for the response of 6 CRFs (BMI, systolic blood pressure, LDL cholesterol, HDL cholesterol, triglycerides, and fasting glucose) to dietary fat.
METHODS


A genome-wide interaction study was undertaken for each CRF in women (n ∼ 9000) not participating in the dietary modification (DM) trial, which focused on the reduction of dietary fat. Genetic scores based on these analyses were developed using a pruning-and-thresholding approach and tested for the prediction of 1-y CRF changes as well as long-term chronic disease development in DM trial participants (n ∼ 5000).
RESULTS


Only 1 of these genetic scores, for LDL cholesterol, predicted changes in the associated CRF. This 1760-variant score explained 3.7% (95% CI: 0.09, 11.9) of the variance in 1-y LDL cholesterol changes in the intervention arm but was unassociated with changes in the control arm. In contrast, a main-effect genetic risk score for LDL cholesterol was not useful for predicting dietary fat response. Further investigation of this score with respect to downstream disease outcomes revealed suggestive differential associations across DM trial arms, especially with respect to coronary heart disease and stroke subtypes.
CONCLUSIONS


These results lay the foundation for the combination of many genome-wide gene-diet interactions for diet response prediction while highlighting the need for further research and larger samples in order to achieve robust biomarkers for use in personalized nutrition.",2020,"This 1760-variant score explained 3.7% (95% CI: 0.09, 11.9) of the variance in 1-y LDL cholesterol changes in the intervention arm but was unassociated with changes in the control arm.","['women (n ∼ 9000) not participating in the dietary modification (DM) trial, which focused on the reduction of dietary fat']",[],"['LDL cholesterol', '1-y LDL cholesterol changes', '6 CRFs (BMI, systolic blood pressure, LDL cholesterol, HDL cholesterol, triglycerides, and fasting glucose) to dietary fat']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708915', 'cui_str': '9000'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}]",[],"[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}]",,0.0283568,"This 1760-variant score explained 3.7% (95% CI: 0.09, 11.9) of the variance in 1-y LDL cholesterol changes in the intervention arm but was unassociated with changes in the control arm.","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Westerman', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Laurence D', 'Initials': 'LD', 'LastName': 'Parnell', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Sebastiani', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jacques', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'DeMeo', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ordovás', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa037']
1511,31507088,Integrated provision of topical pre-exposure prophylaxis in routine family planning services in South Africa: a non-inferiority randomized controlled trial.,"INTRODUCTION


Tenofovir-containing oral pre-exposure prophylaxis (PrEP) is recommended for those at substantial risk as part of combination HIV prevention. However, there are limited data, beyond clinical trial settings, to guide the introduction of PrEP in healthcare services with adequate levels of adherence. Since young women in Africa are at high risk of HIV and likely to utilize family planning (FP) services, the feasibility, acceptability and effectiveness of integrating topical PrEP provision into routine FP services was assessed.
METHODS


This two-arm, randomized controlled, non-inferiority, open-label extension trial was undertaken in urban and rural KwaZulu-Natal, South Africa. HIV-negative eligible women (n = 372) from the parent trial (Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004) were randomized to receive tenofovir gel either through intervention (FP clinics, n = 189) or control clinics (CAPRISA research clinics, n = 183). Non-inferiority was predefined as gel use in the intervention clinics would be no more than 20% lower than in the control clinics. Adherence, retention and HIV incidence rates were assessed.
RESULTS


Women were enrolled between November 2012 and October 2014, and followed up for 682.3 women-years (mean = 22 months). Baseline characteristics of women in intervention and control clinics were comparable and retention rates were 92.1% and 92.3% respectively. Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7) and 5.7 (CI: 5.2 to 6.2) used gel applicators per month respectively, with a mean difference of -0.47 (CI: -1.16 to 0.21). Per-protocol estimates were on average 5.5 (CI: 5.0 to 6.1) and 5.8 (CI: 5.3 to 6.3) respectively, with a mean difference of -0.25 (CI: -0.98 to 0.48), meeting the non-inferiority criteria. Adherence, based on proportion of reported sex acts covered by two gel doses, was 79.9% (CI: 76.7 to 83.2) in intervention compared with 73.9% (CI: 70.7 to 77.1) in control clinics; mean difference:6.0% (CI: 1.5 to 10.6) (p = 0.009). HIV incidence rates were 3.5 (CI: 1.8 to 6.0) and 3.6 (CI: 1.9 to 6.3) per 100 women-years in intervention and control clinics respectively. Both these incidence rates were lower than the age-standardized rate of 6.2 per 100 women-years (n = 444) in the placebo arm of the parent trial (p = 0.019).
CONCLUSIONS


Provision of topical PrEP as part of an integrated FP service achieved higher adherence, and was as feasible, acceptable and effective in preventing HIV as provision through a research setting. This provides useful evidence for scale-up of oral PrEP in urban and rural high burden communities.",2019,"Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7) and 5.7 (CI: 5.2 to 6.2) used gel applicators per month respectively, with a mean difference of -0.47 (CI: -1.16 to 0.21).","['HIV-negative eligible women (n\xa0=\xa0372) from the parent trial (Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004', 'routine family planning services in South Africa', 'urban and rural high burden communities', 'urban and rural KwaZulu-Natal, South Africa', 'Women were enrolled between November 2012 and October 2014, and followed up for 682.3 women-years (mean\xa0=\xa022\xa0months']","['placebo', 'Tenofovir-containing oral pre-exposure prophylaxis (PrEP', 'tenofovir gel either through intervention (FP clinics, n\xa0=\xa0189) or control clinics (CAPRISA research clinics', 'topical pre-exposure prophylaxis']","['retention rates', 'incidence rates', 'HIV incidence rates', 'Adherence, retention and HIV incidence rates']","[{'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",,0.327364,"Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7) and 5.7 (CI: 5.2 to 6.2) used gel applicators per month respectively, with a mean difference of -0.47 (CI: -1.16 to 0.21).","[{'ForeName': 'Leila E', 'Initials': 'LE', 'LastName': 'Mansoor', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Yende-Zuma', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Baxter', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Mngadi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Dawood', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Tanuja N', 'Initials': 'TN', 'LastName': 'Gengiah', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Samsunder', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Schwartz', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Arlington, VA, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Arlington, VA, USA.'}, {'ForeName': 'Quarraisha', 'Initials': 'Q', 'LastName': 'Abdool Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25381']
1512,32436655,"Novel, digital, chest drainage system in cardiac surgery.","BACKGROUND


A new, self-contained, digital, continuous pump-driven chest drainage system is compared in a randomized control trial to a traditional wall-suction system in cardiac surgery.
METHODS


One hundred and twenty adult elective cardiac patients undergoing coronary artery bypass graft and/or valve surgery were randomized to the study or control group. Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2  . Additionally, a satisfaction assessment score (0-10) was performed by 52 staff members.
RESULTS


Given homogenous intra-operative variables, total chest-tube drainage was comparable among groups (566 vs 640 mL; ns), but the study group showed more efficient fluid collection during the early postoperative phase due to continuous suction (P = .01). Blood, cell saver transfusions and postoperative hemoglobin values were similar in both groups. The study group experienced drain removal after 29.8 vs 38.4 hours in the control group (ns). Seven crossovers from the Study to the Control group were registered but no patient had drain-related complications. The Personnel Satisfaction Assessment scored above 5 for all questions asked.
CONCLUSIONS


The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems. Quicker drain removal might impact on intensive care unit (ICU) stay and reduce costs. Additional advantages are portable size, battery operation, patient mobility, noiseless function, digital indications and alarms. The satisfaction assessment of the new system by the staff revealed a higher score when compared to the traditional wall suction chest drainage system.",2020,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","['Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2  ', 'and/or valve surgery', 'One hundred and twenty adult elective cardiac patients undergoing', 'cardiac surgery']",['coronary artery bypass graft'],"['drain-related complications', 'drain removal', 'Blood, cell saver transfusions and postoperative hemoglobin values', 'total chest-tube drainage', 'intensive care unit (ICU) stay and reduce costs', 'satisfaction assessment score', 'efficient fluid collection']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",120.0,0.0347734,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Barozzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Livio San', 'Initials': 'LS', 'LastName': 'Biagio', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Meneguzzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Delphine S', 'Initials': 'DS', 'LastName': 'Courvoisier', 'Affiliation': 'Quality of Care Unit, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Beat H', 'Initials': 'BH', 'LastName': 'Walpoth', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faggian', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}]",Journal of cardiac surgery,['10.1111/jocs.14629']
1513,31881621,Evaluation of Hydrocodone/Acetaminophen for Pediatric Laceration Repair: A Randomized Trial.,"BACKGROUND


Laceration repair is a common procedure, and causes pain and distress in children. The purpose of this study was to measure the effect of hydrocodone/acetaminophen elixir in reducing both pain and anxiety in children undergoing sutured laceration repair in the emergency department.
METHODS


The authors conducted a randomized, double-blinded, placebo-controlled trial in children aged 2 to 17 years, stratified by age younger than 8 years, with topical lidocaine-treated lacerations requiring sutured repair in the emergency department. The primary outcome was pain score at 5 minutes of laceration repair. Secondary outcomes included progression to procedural sedation and anxiety scores in older children.
RESULTS


Eighty-five children were randomized, 43 to the hydrocodone/acetaminophen group and 42 to the placebo group. Median 5-minute pain scores in children aged 2 to 7 years were significantly lower in the medication group (5.0; interquartile range, 4.0 to 6.50) compared with the placebo group (7.0; interquartile range, 5.25 to 10.0; p = 0.01). Three patients (12 percent) in the placebo group proceeded to procedural sedation. For children aged 8 to 17 years, there was no significant difference in pain scores between the treatment (0.5; interquartile range, 0.0 to 0.1; p = 0.81) and placebo groups (0.1; interquartile range, 0.01 to 0.4) or in anxiety scores using the State-Trait Anxiety Inventory for Children.
CONCLUSION


Adjuvant oral hydrocodone/acetaminophen is more effective than placebo in reducing pain in children younger than 8 years undergoing topical lidocaine-treated laceration repair, but it does not decrease pain or anxiety in older children.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"Adjuvant oral hydrocodone/acetaminophen is more effective than placebo in reducing pain in children younger than 8 years undergoing topical lidocaine-treated laceration repair, but it does not decrease pain or anxiety in older children.
","['children', 'Eighty-five children', 'children undergoing sutured laceration repair in the emergency department', 'treated lacerations requiring sutured repair in the emergency department', 'Pediatric Laceration Repair', 'children younger than 8 years undergoing', 'children aged 2 to 17 years, stratified by age younger than 8 years, with']","['Hydrocodone/Acetaminophen', 'hydrocodone/acetaminophen', 'hydrocodone/acetaminophen elixir', 'placebo', 'topical lidocaine']","['progression to procedural sedation and anxiety scores in older children', 'pain scores', 'procedural sedation', 'Median 5-minute pain scores', 'anxiety scores', 'pain score at 5 minutes of laceration repair', 'pain', 'pain and anxiety', 'pain or anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C3472337', 'cui_str': 'Sutured laceration'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}]","[{'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0678430', 'cui_str': 'Elixir (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",85.0,0.708415,"Adjuvant oral hydrocodone/acetaminophen is more effective than placebo in reducing pain in children younger than 8 years undergoing topical lidocaine-treated laceration repair, but it does not decrease pain or anxiety in older children.
","[{'ForeName': 'Corrie E', 'Initials': 'CE', 'LastName': 'Chumpitazi', 'Affiliation': 'Houston, Texas From the Department of Pediatrics, Section of Emergency Medicine, Baylor College of Medicine.'}, {'ForeName': 'A Chantal', 'Initials': 'AC', 'LastName': 'Caviness', 'Affiliation': ''}, {'ForeName': 'Glenda H', 'Initials': 'GH', 'LastName': 'Grawe', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Camp', 'Affiliation': ''}, {'ForeName': 'Manish I', 'Initials': 'MI', 'LastName': 'Shah', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006383']
1514,31881623,Population-Based Health Utility Assessment of Migraine Headache Symptoms before and after Surgical Intervention.,"BACKGROUND


Approximately 30 million Americans suffer from migraine headaches. The primary goals of this study are to (1) use Migraine-Specific Symptoms and Disability criteria and Migraine Headache Index to describe the symptomatic improvement following decompressive surgery for refractory migraines, and (2) use the average Migraine Headache Index preoperatively and postoperatively for health utility assessment from a healthy patient's perspective.
METHODS


The Migraine-Specific Symptoms and Disability criteria and the Migraine Headache Index were used to characterize migraine symptoms in the authors' patient population before and after decompressive surgery. Healthy individuals were randomized to a scenario in which they assumed either the preoperative or postoperative average patient symptom profile described by the authors' migraine patients. Health utility assessments were used to quantify the evaluation of health states the authors' patients experienced before and after surgical migraine therapy.
RESULTS


Twenty-five patients underwent surgery for migraine headaches. The Migraine-Specific Symptoms and Disability questionnaire showed a significant decrease in both frequency of headaches per month (p < 0.0001) and overall pain score (p = 0.007). The Migraine Headache Index demonstrated a statistically significant improvement (p = 0.03). Healthy individuals in the preoperative group had significantly lower utility scores compared with the postoperative group in all of the health utility assessments completed for migraine symptoms.
CONCLUSION


This is the first study to use health utility assessments to attest the efficacy of decompressive therapy by demonstrating the population perspective, which perceived a significant improvement in quality of life following the surgical treatment of migraines in the authors' patients.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, IV.",2020,"Healthy individuals in the preoperative group had significantly lower utility scores compared with the postoperative group in all of the health utility assessments completed for migraine symptoms.
","['Approximately 30 million Americans suffer from migraine headaches', 'Twenty-five patients underwent surgery for migraine headaches', 'Healthy individuals']",[],"['Migraine-Specific Symptoms and Disability criteria and Migraine Headache Index', 'frequency of headaches', 'overall pain score', 'utility scores', 'quality of life', 'average Migraine Headache Index preoperatively and postoperatively for health utility assessment', 'Migraine Headache Symptoms', 'Migraine-Specific Symptoms and Disability questionnaire', 'Migraine Headache Index']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0207698,"Healthy individuals in the preoperative group had significantly lower utility scores compared with the postoperative group in all of the health utility assessments completed for migraine symptoms.
","[{'ForeName': 'Radbeh', 'Initials': 'R', 'LastName': 'Torabi', 'Affiliation': 'New Orleans, La.; Boston, Mass.; and Phoenix, Ariz. From the Department of Surgery, Section of Plastic and Reconstructive Surgery, School of Medicine, Louisiana State University Health Sciences Center; Tulane School of Medicine; the Department of Surgery, Section of Plastic and Reconstructive Surgery, Massachusetts General Hospital; and Elite Plastic Surgery.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Bourn', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Veith', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wisecarver', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Briley', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bartow', 'Affiliation': ''}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Austen', 'Affiliation': ''}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tessler', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006380']
1515,31531997,"The Impact of Preoperative Immunonutrition and Standard Polymeric Supplements on Patient Outcomes After Pelvic Exenteration Surgery, Taking Compliance Into Consideration: A Randomized Controlled Trial.","BACKGROUND


The effect of immunonutrition vs standard polymeric nutrition in the preoperative phase on patient outcomes is still unclear, which could be due to contributing factors such as poorly reported compliance and unequal provision of protein, energy, and volume. The aim of this study was to examine the effects of preoperative immunonutrition compared with standard polymeric supplements matched for energy, protein, volume, length of stay, and postoperative complications in pelvic exenteration surgery, taking into consideration compliance.
METHODS


This was a single-blinded, randomized, controlled trial in patients undergoing pelvic exenteration surgery. Fifty-two participants were randomly assigned to consume 3 immunonutrition supplements/d for 5 days preoperatively, and 56 participants were randomly assigned to consume 3 standard polymeric supplements/d for 5 days preoperatively. Primary and secondary outcome measures were assessed. Compliance with each nutrition regime was recorded during the intervention, and subanalysis was conducted.
RESULTS


There was no significant difference between immunonutrition and standard polymeric supplements on length of stay (P = 0.988) or postoperative complications (P = 0.179) after pelvic exenteration surgery. Compliance with nutrition supplements was significantly less in malnourished (n = 33) compared with well-nourished participants (n = 74) (P = 0.016). Compliance varied between study groups, although not significant.
CONCLUSION


Preoperative immunonutrition did not significantly impact length of stay or postoperative complications compared with standard polymeric supplements after pelvic exenteration surgery, despite controlling for protein, energy, and volume. Compliance, protein, and energy may considerably impact the effect of immunonutrition, particularly in malnourished patients.",2020,There was no significant difference between immunonutrition and standard polymeric supplements on length of stay (P = 0.988) or postoperative complications (P = 0.179) after pelvic exenteration surgery.,"['Patient Outcomes', 'Fifty-two participants', 'malnourished patients', 'patients undergoing pelvic exenteration surgery']","['standard polymeric supplements', 'Preoperative Immunonutrition and Standard Polymeric Supplements', 'preoperative immunonutrition', 'immunonutrition vs standard polymeric nutrition']","['impact length of stay or postoperative complications', 'energy, protein, volume, length of stay, and postoperative complications', 'postoperative complications', 'length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030788', 'cui_str': 'Pelvic Exenteration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",52.0,0.0818895,There was no significant difference between immunonutrition and standard polymeric supplements on length of stay (P = 0.988) or postoperative complications (P = 0.179) after pelvic exenteration surgery.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hogan', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Solomon', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Ferrie', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Carey', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1709']
1516,31838256,Results of the CYP-GUIDES randomized controlled trial: Total cohort and primary endpoints.,"CYP-GUIDES (Cytochrome Psychotropic Genotyping Under Investigation for Decision Support) is a randomized controlled trial (RCT) comparing 2 outcomes in hospitalized patients with major depressive disorder (MDD) treated according to the patient's CYP2D6 genotype and functional status versus standard psychotropic therapy. The primary outcome was hospital Length of Stay (LOS) and the secondary outcome was the Re-Admission Rate (RAR) 30 days after discharge. The trial setting was the Institute of Living at Hartford Hospital. CYP2D6 genotyping was implemented to detect common polymorphisms resulting in an enzyme with sub-normal, normal or supra-normal function. The electronic medical record (EMR) was utilized to transmit clinically actionable drug prescribing guidance based on the patient's CYP2D6 genotype to the physician. The RCT recruited 1500 patients, genotyped CYP2D6 in 1459, and randomized 477 to standard therapy (Group S), for whom treatment-as-usual guidance was delivered without consideration of patient CYP2D6 genotype, and 982 to genetically-guided therapy (Group G) where CYP2D6-based treatment recommendations were provided via EMR to physicians. For inpatients in Group G whose CYP2D6 function was sub- or supra-normal, medications primarily metabolized by the CYP2D6 enzyme were proscribed. The RCT developed a database of potential benefit to the field. The genetic, pharmacologic and clinical information is being simultaneously published. Results did not reveal differences in LOS or RAR between Group G and Group S, but confounders may have obscured the effects of pharmacogenetic guidance. We present strategies to assess effects of pharmacogenetic guidance on the most vulnerable patients at either extreme of CYP2D6 function treated with multiple psychotropics.",2020,"Results did not reveal differences in LOS or RAR between Group G and Group S, but confounders may have obscured the effects of pharmacogenetic guidance.","['vulnerable patients at either extreme of CYP2D6 function treated with multiple psychotropics', 'hospitalized patients with major depressive disorder (MDD']","['CYP-GUIDES (Cytochrome Psychotropic', 'standard psychotropic therapy']","['hospital Length of Stay (LOS', 'LOS or RAR', 'Re-Admission Rate (RAR', 'CYP2D6 function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0010798', 'cui_str': 'Cytochromes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1264195', 'cui_str': 'Refractory anemia with ringed sideroblasts (disorder)'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C0031843', 'cui_str': 'function'}]",1500.0,0.0962851,"Results did not reveal differences in LOS or RAR between Group G and Group S, but confounders may have obscured the effects of pharmacogenetic guidance.","[{'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Ruaño', 'Affiliation': 'Institute of Living at Hartford Hospital, Genomas Laboratory of Personalized Health, 67 Jefferson Street, Hartford, CT 06106, United States. Electronic address: gualberto.ruano@hhchealth.org.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Research Administration, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, United States. Electronic address: saskia.robinson@hhchealth.org.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Holford', 'Affiliation': 'Yale School of Public Health, Yale University, 1 Church Street, 6th Floor Suite, New Haven, CT 06510, United States. Electronic address: theodore.holford@yale.edu.'}, {'ForeName': 'Raveen', 'Initials': 'R', 'LastName': 'Mehendru', 'Affiliation': 'Institute of Living at Hartford Hospital, 200 Retreat Avenue, Hartford, CT 06114, United States. Electronic address: raveen.mehendru@hhchealth.org.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'IInformation Technology Services, Hartford Healthcare, 5 Batterson Park Road, Farmington, CT 06032, United States. Electronic address: seth.baker@hhchealth.org.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tortora', 'Affiliation': 'Research Administration, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, United States. Electronic address: joseph.tortora@hhchealth.org.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Goethe', 'Affiliation': 'Private Medical Practice, 155 Ayrshire Lane, Avon, CT 06001, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105910']
1517,31502003,The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil ® ) Application in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Clinical Trial.,"BACKGROUND


Fibrin sealants and topical glue have been studied to reduce the incidence of postoperative pancreatic fistulas (POPF) after pancreatico-enteric anastomosis, but a definitive innovation is still needed. We aim to evaluate the effectiveness of fibrin sealant patch applied to pancreatico-enteric anastomosis to reduce postoperative complications, including POPF.
METHODS


This study was a single-center, prospective, randomized, phase IV trial involving three pancreaticobiliary surgeons. The primary outcome was POPF; secondary outcomes included complications, drain removal days, hospital stay, readmission rate, and cost. Risk factors for POPF were identified by logistic regression analysis.
RESULTS


A total of 124 patients were enrolled. Biochemical leakage (BL) or POPF occurred in 16 patients (25.8%) in the intervention group and 23 patients (37.1%) in the control group (no statistical significance). Clinically relevant POPF occurred in 4 patients (6.5%) in both the intervention and control groups (p = 1.000). Hospital stay (11.6 days vs. 12.1 days, p = 0.585) and drain removal days (5.7 days vs. 5.3 days, p = 0.281) were not statistically different between two groups. Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103). In multivariable analysis, age and soft pancreas texture were independent risk factors for BL or POPF in this study. Applying fibrin sealant patch is not a negative risk factor, but the p value may indicate a likelihood of reducing the incidence of BL (p = 0.084).
CONCLUSIONS


Fibrin sealant patches after pancreaticojejunostomy did not reduce the incidence of POPF or other postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).",2019,"Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103).",['124 patients were enrolled'],"['fibrin sealant patch', 'Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil ® ']","['drain removal days', 'Biochemical leakage (BL) or POPF', 'incidence of POPF', 'Clinically relevant POPF', 'complications, drain removal days, hospital stay, readmission rate, and cost', 'Hospital stay', 'Complication rates', 'readmission rates']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1276898', 'cui_str': 'Fibrinogen / Thrombin'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1871272', 'cui_str': 'TachoSil'}]","[{'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",124.0,0.166,"Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103).","[{'ForeName': 'Jaewoo', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Division of Hepatobiliary-Pancreatic Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-Ro, Gangnam-gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Guisuk', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Yejong', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Woohyung', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Ki Byung', 'Initials': 'KB', 'LastName': 'Song', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Dae Wook', 'Initials': 'DW', 'LastName': 'Hwang', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Song Cheol', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea. hbpsurgeon@gmail.com.'}]",World journal of surgery,['10.1007/s00268-019-05172-y']
1518,31881599,"Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction.","BACKGROUND


XPAND II was a prospective, multicenter, single-arm, open-label, continued-access study designed to confirm the results from the XPAND study, a multicenter, prospective, randomized study for breast reconstruction. The AeroForm device received clearance from the U.S. Food and Drug Administration in December 2016 based on the results of the pivotal XPAND trial, which compared the AeroForm to saline expanders.
METHODS


Fifty women were treated in the XPAND II study and implanted with the AeroForm device (86 devices). The study endpoint was successful completion of the second-stage surgery, and secondary endpoints were days to complete expansion and reconstruction, and patient/physician satisfaction. Following implantation, women were administered 10-cc doses of carbon dioxide at home up to three times daily. When adequate expansion was achieved, the expanders were exchanged for standard breast implants.
RESULTS


The primary endpoint (successful exchange to standard breast implant, precluding non-device-related failures) is 100 percent. All-cause interim success is 95 percent, with three subjects (four breasts) failing primary exchange because of non-device-related reasons. Median time to complete expansion was 21 days (range, 5 to 117 days). Median time to complete the reconstruction was 112 days (range, 55 to 329 days). Ninety-six percent of the subjects were very or moderately satisfied with the AeroForm expansion process.
CONCLUSIONS


Results of the XPAND II continued access study confirm and improve on previous results from the randomized trial (XPAND). These results validate that the AeroForm patient-controlled, needle-free carbon dioxide tissue expander is safe and effective for two-stage breast reconstruction.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, IV.",2020,"These results validate that the AeroForm patient-controlled, needle-free carbon dioxide tissue expander is safe and effective for two-stage breast reconstruction.
","['Ninety-six percent of the subjects were very or moderately satisfied with the AeroForm expansion process', 'Fifty women were treated in the XPAND II study and implanted with the AeroForm device (86 devices']",['carbon dioxide'],"['Median time to complete expansion', 'Median time', 'successful completion of the second-stage surgery, and secondary endpoints were days to complete expansion and reconstruction, and patient/physician satisfaction', 'primary endpoint (successful exchange to standard breast implant, precluding non-device-related failures']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179412', 'cui_str': 'Breast Prosthesis, Internal'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",50.0,0.0671393,"These results validate that the AeroForm patient-controlled, needle-free carbon dioxide tissue expander is safe and effective for two-stage breast reconstruction.
","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Ascherman', 'Affiliation': ""New York, N.Y.; Campbell and Corte Madera, Calif.; Charlotte, N.C.; Worcester and Boston, Mass.; and Fort Lauderdale, Fla. From the Division of Plastic Surgery, Columbia University College of Physicians and Surgeons, Columbia University Medical Center-New York Presbyterian Hospital; Aesthetx: Aesthetic and Reconstructive Plastic Surgery; Mohebali Plastic Surgery; Novant Health Appel Plastic Surgery; the Division of Plastic Surgery, University of Massachusetts Memorial Medical Center; the Division of Plastic Surgery, Massachusetts General Hospital, Brigham and Women's Faulkner Hospital, Harvard Medical School; and eSSe Plastic Surgery.""}, {'ForeName': 'Kamakshi', 'Initials': 'K', 'LastName': 'Zeidler', 'Affiliation': ''}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Appel', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Castle', 'Affiliation': ''}, {'ForeName': 'Yoon', 'Initials': 'Y', 'LastName': 'Chun', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Colwell', 'Affiliation': ''}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Mohebali', 'Affiliation': ''}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sudarsky', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006395']
1519,31707767,Geriatric Nutritional Risk Index as a prognostic marker in patients with extensive-stage disease small cell lung cancer: Results from a randomized controlled trial.,"BACKGROUND


Clinical impact of the Geriatric Nutritional Risk Index (GNRI) in patients with extensive-stage disease small cell lung cancer (ED-SCLC) have not previously been reported.
METHODS


This study analyzed 352 patients enrolled in a previous randomized phase III trial comparing the efficacy of irinotecan plus cisplatin with that of etoposide plus cisplatin as the first-line therapy for ED-SCLC. GNRI values were calculated using serum albumin levels and actual and ideal bodyweights. Patients with a GNRI > 98, 92-98, and <92 were grouped into no, low, and moderate/major risk groups, respectively.
RESULTS


The objective response rates were 63.2%, 52.6%, and 49.2% in the no, low, and moderate/major risk groups, respectively (P = 0.024). The median progression-free survival (PFS) was shorter in patients with a lower GNRI than in those with a higher GNRI (no vs. low vs. moderate/major risk group; 6.5 vs. 5.8 vs. 5.9 months, respectively; P = 0.028). There were significant differences in median overall survival (OS) according to GNRI (no vs. low vs. moderate/major risk group; 13.2 vs. 10.3 vs. 8.4 months, respectively; P < 0.001). Multivariate analysis revealed that being in the moderate/major risk group was an independent poor prognostic factor for PFS (hazard ratio [HR]: 1.300, 95% confidence interval [CI]: 1.012-1.670; P = 0.040) and OS (HR: 1.539; 95% CI: 1.069-2.216; P = 0.020).
CONCLUSIONS


This prospective study shows that a low GNRI value was associated with a poor prognosis, and it supports the relationship between systemic inflammation, nutritional status, and clinical outcomes in patients with ED-SCLC.Key points SIGNIFICANT FINDINGS OF THE STUDY: The lower GNRI group had a low response rate to chemotherapy for ED-SCLC. The HRs for PFS and OS were 1.300 and 1.539 in the patients with GNRI < 92.
WHAT THIS STUDY ADDS


Low GNRI is associated with poor prognosis in ED-SCLC.",2020,"There were significant differences in median overall survival (OS) according to GNRI (no vs. low vs. moderate/major risk group; 13.2 vs. 10.3 vs. 8.4 months, respectively; P < 0.001).","['Patients with a GNRI\u2009>\u200998, 92-98, and <92 were grouped into no, low, and moderate/major risk groups, respectively', 'patients with extensive-stage disease small cell lung cancer', 'patients with ED-SCLC.Key points', '352 patients enrolled', 'patients with extensive-stage disease small cell lung cancer (ED-SCLC']","['irinotecan plus cisplatin with that of etoposide plus cisplatin', 'Geriatric Nutritional Risk Index', 'Geriatric Nutritional Risk Index (GNRI']","['objective response rates', 'median overall survival (OS', 'median progression-free survival (PFS', 'HRs for PFS and OS', 'serum albumin levels and actual and ideal bodyweights', 'GNRI values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",352.0,0.0566219,"There were significant differences in median overall survival (OS) according to GNRI (no vs. low vs. moderate/major risk group; 13.2 vs. 10.3 vs. 8.4 months, respectively; P < 0.001).","[{'ForeName': 'Gyeong-Won', 'Initials': 'GW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea.'}, {'ForeName': 'Se-Il', 'Initials': 'SI', 'LastName': 'Go', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon, Korea.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Hoon-Gu', 'Initials': 'HG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon, Korea.'}, {'ForeName': 'Joo-Hang', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Ho Jung', 'Initials': 'HJ', 'LastName': 'An', 'Affiliation': ""Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Joung Soon', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Bong-Seog', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Veterans Health Service Medical Center, Seoul, Korea.'}, {'ForeName': 'Seokyung', 'Initials': 'S', 'LastName': 'Hahn', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dae Seog', 'Initials': 'DS', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}]",Thoracic cancer,['10.1111/1759-7714.13229']
1520,31444185,"Clinical and cost-effectiveness of teen online problem-solving for adolescents who have survived an acquired brain injury in the UK: protocol for a randomised, controlled feasibility study (TOPS-UK).","INTRODUCTION


Paediatric acquired brain injury is a leading cause of mortality in children in the UK. Improved treatment during the acute phase has led to increased survival rates, although with life-long morbidity in terms of social and emotional functioning. This is the protocol for a feasibility randomised controlled trial with an embedded qualitative study and feasibility economic evaluation. If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of an online intervention to enhance problem solving ability versus treatment as usual.
METHODS AND ANALYSIS


Twenty-five adolescents and their families identified by primary or secondary care clinicians at participating UK National Health Service Trusts will be recruited and individually randomised in a 1:1 ratio to receive the online intervention or treatment as usual. Participants will be followed up by online questionnaires 17 weeks after randomisation to capture acceptability of the study and intervention and resource use data. Qualitative interviews will capture participants' and clinicians' experiences of the study.
ETHICS AND DISSEMINATION


This study has been granted ethical approval by the South West-Exeter Research Ethics Committee (ref 17/SW/0083). Results will be disseminated via peer-reviewed publications and will inform the design of a larger trial.
TRIAL REGISTRATION NUMBER


ISRCTN10906069.",2019,"If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of an online intervention to enhance problem solving ability versus treatment as usual.
","['children in the UK', 'Twenty-five adolescents and their families identified by primary or secondary care clinicians at participating UK National Health Service Trusts', 'adolescents who have survived an acquired brain injury in the UK']","['online problem-solving', 'online intervention or treatment as usual', 'online intervention']",['survival rates'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",25.0,0.236689,"If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of an online intervention to enhance problem solving ability versus treatment as usual.
","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Limond', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, UK.""}, {'ForeName': 'Patricia Jane', 'Initials': 'PJ', 'LastName': 'Vickery', 'Affiliation': 'Peninsula Clinical Trials Unit, Plymouth University, Plymouth, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jeffery', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Warren', 'Affiliation': 'University of Exeter Medical School, Institute of Health Research, Exeter, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hawton', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Smithson', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Haworth', 'Affiliation': 'Patient Representative, Exeter, UK.'}, {'ForeName': 'Anna-Lynne Ruth', 'Initials': 'AR', 'LastName': 'Adlam', 'Affiliation': 'Psychology, University of Exeter, Exeter, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029349']
1521,29980388,Parental predictors of HPV vaccine initiation among low-income Hispanic females aged 11-17 years.,"PURPOSE


Hispanic women experience a disproportionate burden of cervical cancer morbidity and mortality compared to non-Hispanic women. Increasing HPV vaccination among Hispanic adolescents can help alleviate disparities. This study aimed to identify parental psychosocial predictors associated with HPV vaccine initiation and correlates of parental intentions to obtain the vaccine for their Hispanic adolescent daughters aged 11-17 years.
METHODS


This study is part of a larger three-arm randomized controlled trial testing the effectiveness of interventions to increase HPV vaccination. Parents of adolescent females were recruited in community clinics where we conducted baseline surveys. We obtained electronic medical records six months after baseline to assess vaccination status. Multilevel logistic regression was used to identify correlates of parental intentions to vaccinate and predictors of HPV vaccine initiation. Analyses with initiation as the outcome also controlled for intervention study arm. The Integrated Behavioral Model guided selection of psychosocial and outcome variables.
RESULTS


Our sample (n = 765) consisted mostly of mothers with less than a high school education born outside of the U.S. Forty-one percent had a household income less than $15,000. Most daughters had public or private insurance. Twenty-one percent initiated the HPV vaccine series. Correlates of intention to vaccinate intention included subjective norms related to daughter's doctor (AOR = 1.04; 95% CI 1.01-1.07), belief that the vaccine is safe (AOR = 1.38; 95% CI 1.06-1.78), self-efficacy to obtain the vaccine for their daughter (AOR = 2.39; 95% CI 1.52-3.77), and parental concern about vaccine side effects (AOR = 0.73; 95% CI 0.60-0.89). Intentions predicted initiation (AOR = 2.01; 95% CI 1.10-5.26); concern about sexual disinhibition decreased the odds of having a vaccinated daughter at follow-up (AOR = 0.66; 95% CI 0.47-0.92).
DISCUSSION


Parental intention and concerns about sexual disinhibition predict vaccine initiation. Further research is needed to explore the role of intention as a potential mediator between psychosocial variables and vaccination status.",2018,"Correlates of intention to vaccinate intention included subjective norms related to daughter's doctor (AOR = 1.04; 95% CI 1.01-1.07), belief that the vaccine is safe (AOR = 1.38; 95% CI 1.06-1.78), self-efficacy to obtain the vaccine for their daughter (AOR = 2.39; 95% CI 1.52-3.77), and parental concern about vaccine side effects (AOR = 0.73; 95% CI 0.60-0.89).","['Hispanic women', 'Hispanic adolescent daughters aged 11-17\u202fyears', 'low-income Hispanic females aged 11-17\u202fyears', 'Our sample (n\u202f=\u202f765) consisted mostly of mothers with less than a high school education born outside of the U.S. Forty-one percent had a household income less than $15,000', 'Hispanic adolescents', 'Parents of adolescent females', 'Hispanic women experience']",['HPV vaccine initiation'],"['sexual disinhibition', 'cervical cancer morbidity and mortality', 'self-efficacy', 'HPV vaccination']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3816449', 'cui_str': '40 (qualifier value)'}, {'cui': 'C0557163', 'cui_str': 'Household income (observable entity)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0562557', 'cui_str': 'Sexually disinhibited behavior (finding)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0914143,"Correlates of intention to vaccinate intention included subjective norms related to daughter's doctor (AOR = 1.04; 95% CI 1.01-1.07), belief that the vaccine is safe (AOR = 1.38; 95% CI 1.06-1.78), self-efficacy to obtain the vaccine for their daughter (AOR = 2.39; 95% CI 1.52-3.77), and parental concern about vaccine side effects (AOR = 0.73; 95% CI 0.60-0.89).","[{'ForeName': 'Serena A', 'Initials': 'SA', 'LastName': 'Rodriguez', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Health Science Center at Houston School of Public Health, 7000 Fannin, 25th Floor, Houston, TX 77030, United States; Department of Clinical Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., E5.506S, Dallas, TX 75390, United States. Electronic address: Serena.Rodriguez@UTSouthwestern.edu.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Savas', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Health Science Center at Houston School of Public Health, 7000 Fannin, 25th Floor, Houston, TX 77030, United States. Electronic address: Lara.Staub@uth.tmc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Baumler', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Health Science Center at Houston School of Public Health, 7000 Fannin, 25th Floor, Houston, TX 77030, United States. Electronic address: Elizabeth.R.Baumler@uth.tmc.edu.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Nyitray', 'Affiliation': 'Department of Epidemiology, Human Genetics, and Environmental Sciences, The University of Health Science Center at Houston School of Public Health, 1200 Pressler Street, Houston, TX 77030, United States. Electronic address: Alan.G.Nyitray@uth.tmc.edu.'}, {'ForeName': 'Patricia Dolan', 'Initials': 'PD', 'LastName': 'Mullen', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Health Science Center at Houston School of Public Health, 7000 Fannin, 25th Floor, Houston, TX 77030, United States. Electronic address: Patricia.D.Mullen@uth.tmc.edu.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Health Science Center at Houston School of Public Health, 7000 Fannin, 25th Floor, Houston, TX 77030, United States. Electronic address: Sally.W.Vernon@uth.tmc.edu.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Fernandez', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Health Science Center at Houston School of Public Health, 7000 Fannin, 25th Floor, Houston, TX 77030, United States. Electronic address: Maria.E.Fernandez@uth.tmc.edu.'}]",Vaccine,['10.1016/j.vaccine.2018.06.071']
1522,31894238,Developing preliminary blood metabolomics-based biomarkers of insufficient sleep in humans.,"STUDY OBJECTIVE


Identify small molecule biomarkers of insufficient sleep using untargeted plasma metabolomics in humans undergoing experimental insufficient sleep.
METHODS


We conducted a crossover laboratory study where 16 normal-weight participants (eight men; age 22 ± 5 years; body mass index < 25 kg/m2) completed three baseline days (9 hours sleep opportunity per night) followed by 5-day insufficient (5 hours sleep opportunity per night) and adequate (9 hours sleep opportunity per night) sleep conditions. Energy balanced diets were provided during baseline, with ad libitum energy intake provided during the insufficient and adequate sleep conditions. Untargeted plasma metabolomics analyses were performed using blood samples collected every 4 hours across the final 24 hours of each condition. Biomarker models were developed using logistic regression and linear support vector machine (SVM) algorithms.
RESULTS


The top-performing biomarker model was developed by linear SVM modeling, consisted of 65 compounds, and discriminated insufficient versus adequate sleep with 74% overall accuracy and a Matthew's Correlation Coefficient of 0.39. The compounds in the top-performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism.
CONCLUSION


We identified potential metabolomics-based biomarkers of insufficient sleep in humans. Although our current biomarkers require further development and validation using independent cohorts, they have potential to advance our understanding of the negative consequences of insufficient sleep, improve diagnosis of poor sleep health, and could eventually help identify targets for countermeasures designed to mitigate the negative health consequences of insufficient sleep.",2020,"The compounds in the top performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism.
","['humans', 'humans undergoing experimental insufficient sleep', '16 normal weight participants (8 men; age 22 ± 5 years; body mass index < 25 kg/m2) completed three baseline days (9h sleep opportunity per night) followed by five day insufficient (5h sleep opportunity per night) and adequate (9h sleep opportunity per night) sleep conditions']",[],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],[],65.0,0.0196736,"The compounds in the top performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism.
","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Depner', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Dasha T', 'Initials': 'DT', 'LastName': 'Cogswell', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Bisesi', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Markwald', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Charmion', 'Initials': 'C', 'LastName': 'Cruickshank-Quinn', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Quinn', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Reisdorph', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}]",Sleep,['10.1093/sleep/zsz321']
1523,31726490,A randomized clinical study to compare intrapleural infusion with intravenous infusion of bevacizumab in the management of malignant pleural effusion in patients with non-small-cell lung cancer.,"BACKGROUND


To compare the efficiency and toxicity of bevacizumab by intrapleural or intravenous infusion in the management of malignant pleural effusion in patients with non-small-cell lung cancer (NSCLC).
METHODS


Sensitizing mutation negative NSCLC patients with malignant pleural effusion were randomized into two groups in 1:1 ratio. The pleural effusion was completely drained in 24 hours; one group received intrapleural infusion and the second group received intravenous infusion of bevacizumab at a dose of 7.5 mg per kg bodyweight. The serum vascular endothelial growth factor (VEGF) was tested before and 72 hours after injection of bevacizumab. Computerized tomography (CT) scan to evaluate pleural effusions was carried out at four weeks for each patient and their survival followed-up.
RESULTS


A total of 67 patients were screened and 43 enrolled into the study. The response rate was 80% (16 of 20) in the intrapleural group and 66.7% (14 of 21) in the intravenous group. The median duration of response (DoR) of pleural effusion was 4.50 months and 3.70 months, respectively. The median serum VEGF level at 72 hours decreased 67.25% in the intrapleural group and 57.19% in the intravenous group compared to baseline level (P = 0.276). The median serum VEGF level at 72 hours decreased 52.02% compared to baseline level in patients' DoR less than three months and 68.33% in patients' DoR longer than three months, respectively (P = 0.014). The main side effects noted were mild to moderate hypertension, proteinuria and epistaxis.
CONCLUSIONS


Bevacizumab intrapleural infusion had higher efficiency and higher safety than intravenous infusion in the management of malignant pleural effusion caused by NSCLC. The decreased level of serum VEGF at 72 hours after bevacizumab treatment was closely related to the response rate and duration of the response of pleural effusion.",2020,The median serum VEGF level at 72 hours decreased 67.25% in the intrapleural group and 57.19% in the intravenous group compared to baseline level (P = 0.276).,"['patients with non-small-cell lung cancer', 'patients with non-small-cell lung cancer (NSCLC', '67 patients were screened and 43 enrolled into the study', 'Sensitizing mutation negative NSCLC patients with malignant pleural effusion']","['intravenous infusion of bevacizumab', 'bevacizumab', 'Computerized tomography (CT) scan', 'Bevacizumab intrapleural infusion']","['efficiency and toxicity', 'level of serum VEGF', 'response rate and duration of the response of pleural effusion', 'response rate', 'serum vascular endothelial growth factor (VEGF', 'moderate hypertension, proteinuria and epistaxis', 'median duration of response (DoR) of pleural effusion', 'pleural effusion', 'median serum VEGF level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}]","[{'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0441633'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",67.0,0.081156,The median serum VEGF level at 72 hours decreased 67.25% in the intrapleural group and 57.19% in the intravenous group compared to baseline level (P = 0.276).,"[{'ForeName': 'Keke', 'Initials': 'K', 'LastName': 'Nie', 'Affiliation': 'Department of Oncology, Qingdao Cancer Hospital, Qingdao, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Qingdao Cancer Hospital, Qingdao, China.'}, {'ForeName': 'Yunhong', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Oncology, Qingdao Cancer Hospital, Qingdao, China.'}, {'ForeName': 'Xingjun', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Department of Oncology, PLA 971 Hospital, Qingdao, China.'}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, the Affiliated Qingdao Central Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Youxin', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, the Affiliated Qingdao Central Hospital of Qingdao University, Qingdao, China.'}]",Thoracic cancer,['10.1111/1759-7714.13238']
1524,31950156,Effect of Omega-3 Supplementation in Patients With Smell Dysfunction Following Endoscopic Sellar and Parasellar Tumor Resection: A Multicenter Prospective Randomized Controlled Trial.,"BACKGROUND


Endoscopic endonasal approaches pose the potential risk of olfactory loss. Loss of olfaction and potentially taste can be permanent and greatly affect patients' quality of life. Treatments for olfactory loss have had limited success. Omega-3 supplementation may be a therapeutic option with its effect on wound healing and nerve regeneration.
OBJECTIVE


To evaluate the impact on olfaction in patients treated with omega-3 supplementation following endoscopic skull base tumor resection.
METHODS


In this multi-institutional, prospective, randomized controlled trial, 110 patients with sellar or parasellar tumors undergoing endoscopic resection were randomized to nasal saline irrigations or nasal saline irrigations plus omega-3 supplementation. The University of Pennsylvania Smell Identification Test (UPSIT) was administered preoperatively and at 6 wk, 3 mo, and 6 mo postoperatively.
RESULTS


Eighty-seven patients completed all 6 mo of follow-up (41 control arm, 46 omega-3 arm). At 6 wk postoperatively, 25% of patients in both groups experienced a clinically significant loss in olfaction. At 3 and 6 mo, patients receiving omega-3 demonstrated significantly less persistent olfactory loss compared to patients without supplementation (P = .02 and P = .01, respectively). After controlling for multiple confounding variables, omega-3 supplementation was found to be protective against olfactory loss (odds ratio [OR] 0.05, 95% CI 0.003-0.81, P = .03). Tumor functionality was a significant independent predictor for olfactory loss (OR 32.7, 95% CI 1.15-929.5, P = .04).
CONCLUSION


Omega-3 supplementation appears to be protective for the olfactory system during the healing period in patients who undergo endoscopic resection of sellar and parasellar masses.",2020,"Tumor functionality was a significant independent predictor for olfactory loss (OR 32.7, 95% CI 1.15-929.5, P = .04).
","['patients treated with omega-3 supplementation following endoscopic skull base tumor resection', '110 patients with sellar or parasellar tumors undergoing endoscopic resection', 'patients who undergo endoscopic resection of sellar and parasellar masses', 'Patients With Smell Dysfunction Following Endoscopic Sellar and Parasellar Tumor Resection']","['Omega-3 supplementation', 'nasal saline irrigations or nasal saline irrigations plus omega-3 supplementation', 'Omega-3 Supplementation']","['olfaction', 'protective against olfactory loss', 'persistent olfactory loss', 'olfactory loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0149543', 'cui_str': 'Cranial Base'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of Smell'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}]",110.0,0.0704208,"Tumor functionality was a significant independent predictor for olfactory loss (OR 32.7, 95% CI 1.15-929.5, P = .04).
","[{'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Aakanksha', 'Initials': 'A', 'LastName': 'Rathor', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Kaelyn', 'Initials': 'K', 'LastName': 'Krook', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Rotella', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Dodd', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Hwang', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Jayakar V', 'Initials': 'JV', 'LastName': 'Nayak', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Nelson M', 'Initials': 'NM', 'LastName': 'Oyesiku', 'Affiliation': 'Department of Neurosurgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'DelGaudio', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Levy', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Wise', 'Affiliation': 'Department of Psychology, Oglethorpe University, Atlanta, Georgia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Wise', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Zara M', 'Initials': 'ZM', 'LastName': 'Patel', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}]",Neurosurgery,['10.1093/neuros/nyz559']
1525,31326304,"Daily Oral l-Arginine Plus Tadalafil in Diabetic Patients with Erectile Dysfunction: A Double-Blinded, Randomized, Controlled Clinical Trial.","INTRODUCTION


Erectile dysfunction is a common condition among diabetic men. Many treatments are now available with variable responses.
AIM


This study aimed to evaluate the effect of daily oral l-arginine plus tadalafil in diabetic patients with mild to moderate erectile dysfunction.
METHODS


A double-blinded, randomized, controlled clinical trial was conducted with 108 diabetic male patients. Each patient was assessed by medical and sexual histories, International Index of Erectile Function 5-item questionnaires, pharmaco-penile duplex ultrasonography, and serum testosterone level.
MAIN OUTCOME MEASURE


Improvement in International Index of Erectile Function 5-item, serum testosterone level and pharmaco-penile duplex ultrasonography.
RESULTS


Erectile functions were significantly improved in all patients after treatment as compared with baseline and placebo (P < .001). Patients who received both drugs showed significant improvement compared to those treated with single drugs, as assessed by International Index of Erectile Function scores and total testosterone (P < .001). Pharmaco-penile ultrasound duplex results showed non-significant differences among patients treated with both drugs and those with each drug alone.
CONCLUSION


Daily use of l-arginine with tadalafil significantly increased the International Index of Erectile Function scores and total testosterone levels as compared to each drug alone in diabetic patients with erectile dysfunction. No differences were found based on pharmaco-penile duplex findings. El Taieb M, Hegazy E, Ibrahim A. Daily Orall-Arginine Plus Tadalafil in Diabetic Patients with Erectile Dysfunction: A Double-Blinded, Randomized, Controlled Clinical Trial. J Sex Med 2019; 19:1390-1397.",2019,"Pharmaco-penile ultrasound duplex results showed non-significant differences among patients treated with both drugs and those with each drug alone.
","['diabetic patients with mild to moderate erectile dysfunction', 'diabetic men', 'diabetic patients with erectile dysfunction', 'Diabetic Patients with Erectile Dysfunction', '108 diabetic male patients']","['placebo', 'El Taieb M, Hegazy E, Ibrahim A. Daily Orall-Arginine Plus Tadalafil', 'l-arginine with tadalafil', 'daily oral l-arginine plus tadalafil', 'Daily Oral l-Arginine Plus Tadalafil']","['International Index of Erectile Function 5-item, serum testosterone level and pharmaco-penile duplex ultrasonography', 'medical and sexual histories, International Index of Erectile Function 5-item questionnaires, pharmaco-penile duplex ultrasonography, and serum testosterone level', 'International Index of Erectile Function scores and total testosterone', 'International Index of Erectile Function scores and total testosterone levels', 'Erectile functions']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0444916', 'cui_str': 'Duplex (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",108.0,0.490958,"Pharmaco-penile ultrasound duplex results showed non-significant differences among patients treated with both drugs and those with each drug alone.
","[{'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'El Taieb', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Aswan University, Sahary City, Aswan, Egypt. Electronic address: moustafa.eltaib@aswu.edu.eg.'}, {'ForeName': 'Eisa', 'Initials': 'E', 'LastName': 'Hegazy', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, South Valley University, Qena, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Asuit University, Asyut, Egypt.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.06.009']
1526,31774581,Exploring nonverbal synchrony in borderline personality disorder: A double-blind placebo-controlled study using oxytocin.,"OBJECTIVES


Interpersonal dysfunction is a central feature of borderline personality disorder (BPD), and the neuropeptide oxytocin (OT) has been shown to impact patients' behaviour in numerous ways. Nonverbal signals such as the coordination of body movement (nonverbal synchrony) are associated with the success of interpersonal exchanges and could thus be influenced by features of BPD and by the administration of OT.
DESIGN


We explored the effect of intranasal OT (inOT) on nonverbal synchrony in sixteen patients with BPD and fifteen healthy controls (CTL) randomly assigned to two double-blind clinical interviews under inOT and placebo (PL).
METHODS


Nonverbal synchrony was assessed by automated video-analyses of subject's and interviewer's body movement. Lagged cross-correlations were used to objectively quantify coordination in dyads.
RESULTS


Synchrony was higher than pseudosynchrony (= synchrony expected by chance), and there was a differential effect of inOT between groups: While healthy controls displayed increased synchrony under inOT, patients with BPD showed low levels of synchrony under inOT. Additionally, patient's synchrony was negatively associated with self-reported childhood trauma.
CONCLUSIONS


Nonverbal synchrony in clinical interviews is influenced by inOT, and this effect depends on subject's diagnosis. In line with previous research implying positive associations between nonverbal synchrony and relationship quality, inOT led to an increase of synchrony in healthy controls, but not in patients with BPD. Low levels of synchrony under inOT in patients and its association with childhood trauma suggest that additional mechanisms such as rejection sensitivity might mediate BPD patients' nonverbal behaviour.
PRACTITIONER POINTS


Intranasal oxytocin (inOT) attenuated nonverbal synchrony - a proxy for relationship quality - in patients with borderline personality disorder (BPD), while it increased nonverbal synchrony in healthy controls (CTL). Available models (rejection sensitivity; social salience) suggest that inOT may alter the way patients with BPD assess social situations, and this alteration is expressed by changes in nonverbal coordination. Patients with BPD display low levels of synchrony which are even below expected pseudosynchrony based on chance. The association between self-reported childhood trauma and lower synchrony in BPD was most evident for patient's imitative behaviour: Under inOT, patients with high scores of childhood trauma refrained from imitating their interview partners. Study limitations include small sample sizes and limited data on the psychological impact of the clinical interviews.",2020,"Nonverbal signals such as the coordination of body movement (nonverbal synchrony) are associated with the success of interpersonal exchanges and could thus be influenced by features of BPD and by the administration of OT.
","['sixteen patients with BPD and fifteen healthy controls (CTL', 'patients with borderline personality disorder (BPD', 'borderline personality disorder', 'patients with BPD assess social situations']","['intranasal OT (inOT', 'oxytocin', 'placebo', 'neuropeptide oxytocin (OT', 'Intranasal oxytocin (inOT) attenuated nonverbal synchrony - a proxy', 'placebo (PL']",['nonverbal synchrony'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}]",[],,0.0444286,"Nonverbal signals such as the coordination of body movement (nonverbal synchrony) are associated with the success of interpersonal exchanges and could thus be influenced by features of BPD and by the administration of OT.
","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Ramseyer', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ebert', 'Affiliation': 'Division of Social Neuropsychiatry and Evolutionary Medicine, Department of Psychiatry, Psychotherapy and Preventive Medicine, LWL University Hospital Bochum, Ruhr-University Bochum, Germany.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Roser', 'Affiliation': 'Centre for Addiction Disorders, Psychiatric Hospital Königsfelden, Psychiatric Services Aargau, Academic Hospital of the University of Zurich, Switzerland.'}, {'ForeName': 'Marc-Andreas', 'Initials': 'MA', 'LastName': 'Edel', 'Affiliation': 'Fliedner Klinic, Gevelsberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Tschacher', 'Affiliation': 'Department of Experimental Psychology, University Hospital of Psychiatry and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Brüne', 'Affiliation': 'Division of Social Neuropsychiatry and Evolutionary Medicine, Department of Psychiatry, Psychotherapy and Preventive Medicine, LWL University Hospital Bochum, Ruhr-University Bochum, Germany.'}]",The British journal of clinical psychology,['10.1111/bjc.12240']
1527,31486729,Protocol for a Cluster Randomized Trial Comparing Team-Based to Clinician-Focused Implementation of Advance Care Planning in Primary Care.,"Introduction:  For many patients, primary care is an appropriate setting for advance care planning (ACP). ACP focuses on what matters most to patients and ensuring health care supports patient-defined goals. ACP may involve interactions between a clinician and a patient, but for seriously ill patients ACP could be managed by a team.  Methods:  We are conducting a cluster randomized trial comparing team-based to clinician-focused ACP using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs). Practices were randomized to one of the two models. Patients are referred to the study after engaging in ACP in primary care. Our target enrollment is 1260 subjects. Patient data are collected at enrollment, six months and one year. Primary outcomes are patient-reported goal-concordant care and days at home. Secondary outcomes include additional patient measures, clinician/team experience, and practice-level measures of SICP implementation.  Study Implementation:  This trial was designed and is conducted by the Meta-network Learning and Research Center (Meta-LARC), a consortium of PBRNs focused on integrating engagement with patients, families, and other stakeholders into primary care research and practice. The trial pairs a comparative effectiveness study with implementation of a new program and is designed to balance fidelity to the assigned model with flexibility to allow each practice to adapt implementation to their environment and priorities. Our dissemination will report the results of comparing the two models and the implementation experience of the practices to create guidance for the spread of ACP in primary care.",2019,We are conducting a cluster randomized trial comparing team-based to clinician-focused ACP using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs).,"['42 practices recruited from 7 practice-based research networks (PBRNs', '1260 subjects']","['ACP', 'clinician-focused ACP using the Serious Illness Care Program (SICP']","['additional patient measures, clinician/team experience, and practice-level measures of SICP implementation', 'patient-reported goal-concordant care and days at home']","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035168'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",1260.0,0.0420048,We are conducting a cluster randomized trial comparing team-based to clinician-focused ACP using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs).,"[{'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Totten', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Lyle J', 'Initials': 'LJ', 'LastName': 'Fagnan', 'Affiliation': 'Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dorr', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'LeAnn C', 'Initials': 'LC', 'LastName': 'Michaels', 'Affiliation': 'Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Shigeko Seiko', 'Initials': 'SS', 'LastName': 'Izumi', 'Affiliation': 'School of Nursing, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Combe', 'Affiliation': 'Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': ""Centre de Recherche Sur Les Soins et Les Services de Première Ligne de l'Université Laval, Quebec, Canada.""}]",Journal of palliative medicine,['10.1089/jpm.2019.0117']
1528,31486730,"A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC).","Background:  Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.  Objectives and Hypotheses:  Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients.  Methods:  Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization.  Setting:  Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020.  Participants:  Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer.  Interventions:  In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team.  Main Outcomes and Measures:  Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used.  Ethics and Dissemination:  This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).",2019,"Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.  ","['patients pursuing curative-intent surgery for upper GI cancers', '8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients', 'for Patients and Their Family Members (PERIOP-PC', 'Setting:  Four, geographically diverse, academic tertiary care hospitals', 'patients with upper gastrointestinal (GI) cancers', 'Participants:  Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer']","['surgeon-PC co-management with surgeon-alone management', 'specialist palliative care (PC', 'usual care arm receive care from only the surgical team', 'Perioperative Palliative Care Surrounding Cancer Surgery']","['patient postsurgical quality of life', 'patient quality of life', 'Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness', 'symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0920424'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C1515090', 'cui_str': 'Surgical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0920424'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0150081', 'cui_str': 'Spiritual distress (finding)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.131645,"Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.  ","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Aslakson', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Shivani V', 'Initials': 'SV', 'LastName': 'Chandrashekaran', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rickerson', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Bridget N', 'Initials': 'BN', 'LastName': 'Fahy', 'Affiliation': 'Department of Surgery, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Fabian M', 'Initials': 'FM', 'LastName': 'Johnston', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Miller', 'Affiliation': 'Patient-family partner, Ellicott City, Maryland.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conca-Cheng', 'Affiliation': 'The Warren Alpert Medical School, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Suwei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Arden M', 'Initials': 'AM', 'LastName': 'Morris', 'Affiliation': 'Stanford-Surgery Policy Improvement Research and Education Center, Stanford University, Stanford, California.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lorenz', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0130']
1529,31488289,The Effect of Food on the Pharmacokinetics of Sildenafil after Single Administration of a Sublingual Testosterone and Oral Sildenafil Combination Tablet in Healthy Female Subjects.,"INTRODUCTION


Female sexual interest/arousal disorder (FSIAD) affects many women worldwide, but pharmacological treatment options are scarce. A new medicine being developed for FSIAD is an on-demand, dual-route, dual-release drug combination product containing 0.5 mg testosterone (T) and 50 mg sildenafil (S), referred to here as T+S.
AIM


The aim of this study was to compare the effect of a fed and a fasted state on the pharmacokinetics of sildenafil following administration of T+S.
METHODS


Eighteen healthy women were administered T+S under fed and fasted conditions during 2 separate overnight visits in this randomized, open-label, balanced, 2-period, 2-treatment, 2-sequence crossover study.
MAIN OUTCOME MEASURES


The pharmacokinetics of sildenafil and its active metabolite N-desmethyl sildenafil were determined over a 24-hour period. Total testosterone was assessed only at a limited number of time points for quality purposes, as sublingual uptake is not expected to be affected by food intake.
RESULTS


The observed geometric mean ratios (GMRs) and 90% confidence intervals of sildenafil were not all contained within the prespecified bounds (0.80, 1.25). The GMR (90% CI) for plasma AUC 0-last  was 1.2753 (0.9706-1.6755); for AUC 0-14h , it was 1.7521 (1.0819-2.8374); and for C max , it was 1.5591 (0.8634-2.8153). Only lower limits of the CIs fell within the bounds. For N-desmethyl sildenafil, the GMR (90% CI) for AUC 0-last  was 0.8437 (0.6738-1.0564); for AUC 0-10h , it was 1.0847 (0.7648-1.5383); and for C max , it was 1.0083 (0.6638-1.5318). Only the GMRs were contained within bounds. No differences were observed between plasma testosterone C max  and T max  under fed and fasted conditions, which is in line with expectations for a sublingual administration.
CLINICAL IMPLICATIONS


The T+S combination tablet ruptures too late when taken in a fasted state and should therefore not be taken on an empty stomach.
STRENGTHS & LIMITATIONS


This is a well-controlled study that provides important insights into the performance characteristics of the delayed-release coating of the combination tablet. The higher variability of the pharmacokinetic parameters in the fasted state was caused by severely delayed rupture in one-third of the women. A reason for this is proposed but the present data do not explain this phenomenon.
CONCLUSION


The pharmacokinetics of sildenafil from this modified-release tablet are more robust under fed conditions as compared to the artificial fasted condition where no food is consumed 10 hours prior to and 4 hours after dosing. The dosing situation under the tested fasting condition does not represent the expected common use of this product. Patients should, however, be instructed not to take the tablet on an empty stomach. Bloemers J, Gerritsen J, van Rooij K, et al. The Effect of Food on the Pharmacokinetics of Sildenafil After Single Administration of a Sublingual Testosterone and Oral Sildenafil Combination Tablet in Healthy Female Subjects. J Sex Med 2019; 19:1433-1443.",2019,"No differences were observed between plasma testosterone C max  and T max  under fed and fasted conditions, which is in line with expectations for a sublingual administration.
","['Healthy Female Subjects', 'Eighteen healthy women']","['testosterone (T) and 50 mg sildenafil (S', 'sildenafil', 'T+S', 'sildenafil and its active metabolite N-desmethyl sildenafil', 'Sildenafil', 'Sublingual Testosterone and Oral Sildenafil Combination Tablet']","['observed geometric mean ratios (GMRs) and 90% confidence intervals of sildenafil', 'Total testosterone', 'plasma testosterone C max  and T max  under fed and fasted conditions', 'plasma AUC 0-last']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1665319', 'cui_str': 'Desmethylsildenafil'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",18.0,0.1162,"No differences were observed between plasma testosterone C max  and T max  under fed and fasted conditions, which is in line with expectations for a sublingual administration.
","[{'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Bloemers', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands; Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, the Netherlands. Electronic address: j.bloemers@emotionalbrain.nl.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Gerritsen', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Rooij', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands; Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'de Leede', 'Affiliation': 'Exelion Bio-Pharmaceutical Consultancy BV, Waddinxveen, the Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van der Geest', 'Affiliation': '3D-PharmXchange BV, Tilburg, the Netherlands.'}, {'ForeName': 'Henderik W', 'Initials': 'HW', 'LastName': 'Frijlink', 'Affiliation': 'Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hans P F', 'Initials': 'HPF', 'LastName': 'Koppeschaar', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Olivier', 'Affiliation': 'Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, the Netherlands; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Tuiten', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.06.015']
1530,31490817,Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial.,"BACKGROUND


Pupillometry monitoring under general anesthesia is based on the assumption that pupillary diameter variations reflect the adequacy of the provided analgesia to the intensity of the nociceptive surgical stimulus. The accurate interpretation of pupillometric data requires establishing clearly what the expected baseline unstimulated pupillary diameter at each specific level of hypnosis is. Opioids decrease pupillary diameter in a dose-dependent fashion. In contrast, the effects of hypnotic drugs on pupillary diameter are not well known. Our aim was to describe the potential relationship between propofol predicted effect-site concentrations (Cets) ranging from 1 to 3 µg/mL and pupillary diameter.
METHODS


Patients were randomized to receive propofol by target-controlled infusion at a predicted Cet of 1, 2, or 3 µg/mL (groups P1, P2, and P3, respectively). Pupillary diameter measurements were performed after 10 minutes of steady-state propofol infusion at the randomized Cet. No stimulation was performed during the study. Heart rate and bispectral index (BIS) were continuously recorded.
RESULTS


Forty patients were included: (13, 14, and 13 in groups P1, P2, and P3, respectively). Mean pupillary diameter was 5.7 mm (1 mm) in group P1, 4.8 mm (1.3 mm) in group P2, and 3.3 mm (0.8 mm) in group P3. Propofol had a dose-dependent effect on pupillary diameter (linear regression R = 0.45, P < .001). Pupillary diameter was positively correlated with the BIS (Spearman r = 0.75 [95% confidence interval (CI), 0.54 to -0.87] P < .001).
CONCLUSIONS


From 1 to 3 µg/mL of predicted Cet, propofol has a dose-dependent effect on pupillary diameter. Within this concentrations range, there is a positive correlation between BIS and pupillary diameter. The subcortical effect of propofol on pupillary diameter is correlated to its effect on the cortex. Studies assessing pupillary diameter as a marker of the nociception-antinociception balance should be performed in patients with a standardized depth of hypnosis.",2020,"Mean pupillary diameter was 5.7 mm (1 mm) in group P1, 4.8 mm (1.3 mm) in group P2, and 3.3 mm (0.8 mm) in group P3.","['Patients', 'patients with a standardized depth of hypnosis']","['propofol', 'Propofol']","['Mean pupillary diameter', 'Opioids decrease pupillary diameter', 'pupillary diameter', 'Pupillary diameter measurements', 'Pupillary diameter', 'Heart rate and bispectral index (BIS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}]",40.0,0.0349464,"Mean pupillary diameter was 5.7 mm (1 mm) in group P1, 4.8 mm (1.3 mm) in group P2, and 3.3 mm (0.8 mm) in group P3.","[{'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Sabourdin', 'Affiliation': ""From the Département d'anesthesiologie, Hôpital Armand Trousseau, Paris, France.""}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Meniolle', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Chemam', 'Affiliation': ''}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Rigouzzo', 'Affiliation': ''}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Hamza', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Louvet', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Constant', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004362']
1531,31894015,The Community Resiliency Model® to promote nurse well-being.,"BACKGROUND


Rising rates of secondary traumatic stress and burnout among nurses signal a crisis in healthcare. There is a lack of evidence regarding effective interventions to improve nurse well-being and resiliency.
PURPOSE


This study used a randomized controlled trial parallel design to test the effectiveness of a 3-hour Community Resiliency Model® (CRM) training, a novel set of sensory awareness techniques to improve emotional balance.
METHODS


Registered nurses in two urban tertiary-care hospitals were invited to participate, which entailed attending a single 3-hour ""Nurse Wellness and Well-being"" class; 196 nurses consented and were randomized into the CRM intervention or nutrition education control group to determine if the CRM group would demonstrate improvement in well-being and resiliency, secondary traumatic stress, burnout, and physical symptoms.
FINDINGS


Pre/post data were analyzed for 40 CRM and 37 nutrition group members. Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms. Participants reported using CRM techniques for self-stabilization during stressful work events.
DISCUSSION


CRM shows promise as a brief resiliency training for hospital-based nurses.",2020,"Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms.","['nurses signal a crisis in healthcare', 'Registered nurses in two urban tertiary-care hospitals were invited to participate, which entailed attending a single 3-hour ""Nurse Wellness and Well-being"" class; 196 nurses consented']","['CRM intervention or nutrition education control', 'CRM', '3-hour Community Resiliency Model® (CRM) training']","['well-being, resiliency, secondary traumatic stress, and physical symptoms']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",196.0,0.0288997,"Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Grabbe', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA. Electronic address: lgrabbe@emory.edu.'}, {'ForeName': 'Melinda K', 'Initials': 'MK', 'LastName': 'Higgins', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Baird', 'Affiliation': 'Emory Healthcare, Atlanta, GA.'}, {'ForeName': 'Patricia Ann', 'Initials': 'PA', 'LastName': 'Craven', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'San Fratello', 'Affiliation': 'Emory Healthcare, Atlanta, GA.'}]",Nursing outlook,['10.1016/j.outlook.2019.11.002']
1532,31951148,[Dental anxiety in preschool children: How helpful are behavioral control management strategies?],"Dental anxiety in preschool children: How helpful are behavioral control management strategies?  Abstract.   Objective:  Dental anxiety is a frequent problem in the dental treatment of young children. Control management methods are widely used in pediatric dental care as coping strategies. This study compares two control management strategies regarding their reduction of dental anxiety and treatment success.  Method:  A group of 60 preschool children with known dental fear in their medical history underwent professional dental cleaning in which the Tell-Show-Do Method (TSDM) was applied. Patients were randomized into two groups according to the controlling method employed: (1) limited controlling method (L-K) and (2) standardized controlling method (S-K). The efficacy of the two control methods was tested using pulse rate as an objective measure of anxiety and self-rating as a subjective indicator.  Results:  Both the S-K and the L-K condition showed a significant reduction in pulse rate, and there was no difference in physiological arousal and treatment success. However, independent of the group disposition, there was a noticeable increase in pulse rate in children after TSDM.  Conclusion:  The results of this study indicate that even limited options for controlling dental treatment do not lead to greater burdens on the children in question with dental anxiety. However, further studies are necessary to investigate the use of control methods independent of TSDM.",2020,"Both the S-K and the L-K condition showed a significant reduction in pulse rate, and there was no difference in physiological arousal and treatment success.","['60 preschool children with known dental fear in their medical history', 'young children', 'preschool children']",['professional dental cleaning in which the Tell-Show-Do Method (TSDM'],"['Dental anxiety', 'pulse rate', 'physiological arousal and treatment success']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0203604,"Both the S-K and the L-K condition showed a significant reduction in pulse rate, and there was no difference in physiological arousal and treatment success.","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Pfau', 'Affiliation': 'Kinder- und Jugendpsychiatrie, Basel, Schweiz.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Stratigaki', 'Affiliation': 'Kinderzahnmedizin, Adligenswil, Schweiz.'}, {'ForeName': 'Carlaalberta', 'Initials': 'C', 'LastName': 'Verna', 'Affiliation': 'Klinik für Kieferorthopädie und Kinderzahnmedizin, Basel, Schweiz.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Stadler', 'Affiliation': 'Kinder- und Jugendpsychiatrie, Basel, Schweiz.'}]",Zeitschrift fur Kinder- und Jugendpsychiatrie und Psychotherapie,['10.1024/1422-4917/a000703']
1533,31486726,Development of an Outpatient Palliative Care Protocol to Monitor Fidelity in the Emergency Medicine Palliative Care Access Trial.,"Introduction:  Palliative care is recommended for patients with life-limiting illnesses; however, there are few standardized protocols for outpatient palliative care visits. To address the paucity of data, this article aims to: (1) describe the elements of outpatient palliative care that are generalizable across clinical sites; (2) achieve consensus about standardized instruments used to assess domains within outpatient palliative care; and (3) develop a protocol and intervention checklist for palliative care clinicians to document outpatient visit elements that might not normally be recorded in the electronic heath record.  Methods:  As part of a randomized control trial of nurse-led telephonic case management versus specialty, outpatient palliative care in older adults with serious life-limiting illnesses in the Emergency Department, we assessed the structural characteristics of outpatient care clinics across nine participating health care systems. In addition, direct observation of outpatient palliative care visits, consultation from content experts, and survey data were used to develop an outpatient palliative care protocol and intervention checklist.  Implementation:  The protocol and checklist are being used to document the contents of each outpatient palliative care visit conducted as a part of the Emergency Medicine Palliative Care Access (EMPallA) trial. Variation across palliative care team staffing, clinic session capacity, and physical clinic model presents a challenge to standardizing the delivery of outpatient palliative care.",2019,"As part of a randomized control trial of nurse-led telephonic case management versus specialty, outpatient palliative care in older adults with serious life-limiting illnesses in the Emergency Department, we assessed the structural characteristics of outpatient care clinics across nine participating health care systems.","['patients with life-limiting illnesses', 'outpatient care clinics across nine participating health care systems', 'older adults with serious life-limiting illnesses in the Emergency Department']","['nurse-led telephonic case management versus specialty, outpatient palliative care']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]",[],,0.0364681,"As part of a randomized control trial of nurse-led telephonic case management versus specialty, outpatient palliative care in older adults with serious life-limiting illnesses in the Emergency Department, we assessed the structural characteristics of outpatient care clinics across nine participating health care systems.","[{'ForeName': 'Corita R', 'Initials': 'CR', 'LastName': 'Grudzen', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Schmucker', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Shim', 'Affiliation': 'Augusta University Medical College of Georgia, Augusta, Georgia.'}, {'ForeName': 'Aminat', 'Initials': 'A', 'LastName': 'Ibikunle', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Chung', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohen', 'Affiliation': 'Department of Internal Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of palliative medicine,['10.1089/jpm.2019.0115']
1534,31484191,"The Effect of Cynara scolymus on Blood Pressure and BMI in Hypertensive Patients: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.","BACKGROUND


Recent studies have suggested that artichoke (Cynara scolymus L.) may reduce certain biochemical blood factors but the efficacy of this plant on blood pressure (BP) has not yet been investigated. In this study, we determined the clinical efficacy of C. scolymuson BP and body mass index (BMI) in hypertensive patients as an adjunctive to captopril for the first time.
METHODS


The total phenolic content and gas chromatography-mass spectrometry metabolite profiling in leaves of C. scolymus have been evaluated. A clinical trial was subsequently carried out on 40 patients to determine the effect of C. scolymus on BP and BMI in hypertensive patients. The treatment group received capsules containing C. scolymus(500 mg twice daily) and the placebo group received starch powder for 8 weeks. Systolic blood pressure (SBP), diastolic blood pressure, and BMI were determined before and after the study.
RESULTS


A significant improvement of the BMI was seen in the C. scolymus group compared with the placebo group (p = 0.04).
CONCLUSIONS


Our findings demonstrated that the consumption of C. scolymus powder as a rich source of phenolic and antioxidant compounds could potentially improve BMI and SBP in hypertensive patients. Therefore, more trials are needed to confirm or reject the antihypertensive impact of artichoke.",2020,"A significant improvement of the BMI was seen in the C. scolymus group compared with the placebo group (p = 0.04).
","['hypertensive patients', 'Hypertensive Patients', '40 patients']","['Placebo', 'capsules containing C. scolymus(500 mg twice daily) and the placebo group received starch powder', 'placebo', 'Cynara scolymus', 'captopril']","['BP and BMI', 'clinical efficacy of C. scolymuson BP and body mass index (BMI', 'blood pressure (BP', 'Systolic blood pressure (SBP), diastolic blood pressure, and BMI', 'Blood Pressure and BMI', 'BMI', 'BMI and SBP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0301424', 'cui_str': 'Starch powder (substance)'}, {'cui': 'C1021820', 'cui_str': 'Cynara scolymus'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",,0.180071,"A significant improvement of the BMI was seen in the C. scolymus group compared with the placebo group (p = 0.04).
","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Ardalani', 'Affiliation': 'Department of Horticultural Sciences, Science and Research Branch, Islamic Azad University, Tehran, Iran, hrardalani@gmail.com.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Jandaghi', 'Affiliation': 'Children Growth Research Center, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Aramsadat', 'Initials': 'A', 'LastName': 'Meraji', 'Affiliation': 'Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hassanpour Moghadam', 'Affiliation': 'Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Complementary medicine research,['10.1159/000502280']
1535,31485809,"Comparison Between Preoperative and Intraoperative Administration of Nefopam for Acute and Chronic Postoperative Pain in Colon Cancer Patients: A Prospective, Randomized, Double-Blind Study.","BACKGROUND


The present study was designed as a prospective, randomized, double-blind clinical trial to evaluate the effects of preoperatively administered nefopam on postoperative acute hyperalgesia and the long-term painful sequelae compared to intraoperative administration.
METHODS


One hundred and fifty patients undergoing elective laparoscopic colectomy were enrolled. Group 1 (post-incisional nefopam) patients received saline at 30 min before skin incision followed by intraoperative administration of 20 mg nefopam at 1 h after incision. Group 2 (pre-incisional nefopam) patients were administered 20 mg nefopam before skin incision and received saline after skin incision. At postoperative 2, 6, 24, 48, and 72 h, fentanyl consumption and pain intensities at rest and during deep breathing were evaluated by visual analog scale (VAS). The incidence of the long-term painful sequelae after surgery was evaluated more than one year after surgery.
RESULTS


Cumulative fentanyl consumption during postoperative 72 h was similar between Group 1 and Group 2 (1534 ± 698 μg, 95% CI 1367-1702 μg vs. 1442 ± 721 μg, 95% CI 1266-1618 μg, P = 0.197). VAS pain scores at rest were comparable between the two groups, but VAS scores during deep breathing were significantly lower in Group 2 than in Group 1. Six and five patients complained of mild pain (pain rating 1) at the surgical site in Group 1 and 2, respectively.
CONCLUSIONS


Preoperatively administered nefopam reduced exertional pain compared to intraoperative administration although postoperative analgesic consumption was similar between two groups. It may be helpful to conduct early ambulation and deep breathing during the acute postoperative period in patients undergoing intestinal surgery. Trial registration No: KCT0001656.",2019,Preoperatively administered nefopam reduced exertional pain compared to intraoperative administration although postoperative analgesic consumption was similar between two groups.,"['One hundred and fifty patients undergoing elective laparoscopic colectomy were enrolled', 'patients undergoing intestinal surgery', 'Colon Cancer Patients']","['saline at 30\xa0min before skin incision followed by intraoperative administration of 20\xa0mg nefopam at 1\xa0h after incision', '20\xa0mg nefopam before skin incision and received saline after skin incision', 'Nefopam']","['exertional pain', 'postoperative analgesic consumption', 'VAS pain scores', 'incidence of the long-term painful sequelae', 'Cumulative fentanyl consumption', 'visual analog scale (VAS', 'VAS scores during deep breathing', 'fentanyl consumption and pain intensities at rest and during deep breathing', 'mild pain', 'postoperative acute hyperalgesia']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1328799', 'cui_str': 'Deep breathing (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}]",150.0,0.606468,Preoperatively administered nefopam reduced exertional pain compared to intraoperative administration although postoperative analgesic consumption was similar between two groups.,"[{'ForeName': 'Hyungsun', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Sehrin', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Seonghoon', 'Initials': 'S', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea. shko@jbnu.ac.kr.'}]",World journal of surgery,['10.1007/s00268-019-05119-3']
1536,31486721,Early Integrated Telehealth versus In-Person Palliative Care for Patients with Advanced Lung Cancer: A Study Protocol.,"Introduction:  Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer. The aims of this trial are to compare the effect of delivering early integrated PC through telehealth versus in-person on patient and caregiver outcomes. We hypothesize that both modalities for delivering early PC would be equivalent for improving patient QOL, communication about EOL care preferences with their oncologist, and length of stay in hospice.  Methods:  For this comparative effectiveness trial, we will enroll and randomize 1250 adult patients with advanced nonsmall cell lung cancer (NSCLC), who are not being treated with curative intent, to receive either early integrated telehealth or in-person PC at 20 cancer centers throughout the United States. Patients may also invite a family caregiver to participate in the study. Patients and their caregivers in both study groups meet at least every four weeks with a PC clinician from within 12 weeks of patient diagnosis of advanced NSCLC until death. Participants complete measures of QOL, mood, and quality of communication with oncologists at baseline before randomization and at 12, 24, 36, and 48 weeks. Information on health care utilization, including length of stay in hospice, will be collected from patients' health records. To test equivalence in outcomes between study groups, we will compute analysis of covariance and mixed linear models, controlling for baseline scores and study site.  Study Implementation and Stakeholder Engagement:  To ensure that this comparative effectiveness trial and findings are as patient centered and meaningful as possible, we have incorporated a robust patient and stakeholder engagement plan. Our stakeholder partners include (1) patients/families, (2) PC clinicians, (3) telehealth experts and clinician users, (4) representatives from health care systems and medical insurance providers, and (5) health care policy makers and advocates. These stakeholders will inform and provide feedback about every phase of study implementation.",2019,"Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer.","['Our stakeholder partners include (1) patients/families, (2) PC clinicians, (3) telehealth experts and clinician users, (4) representatives from health care systems and medical insurance providers, and (5) health care policy makers and advocates', 'Patients with Advanced Lung Cancer', '1250 adult patients with advanced nonsmall cell lung cancer (NSCLC), who are not being treated with curative intent, to receive either early integrated telehealth or in-person PC at 20 cancer centers throughout the United States', 'patients with advanced lung cancer']",['Early Integrated Telehealth versus In-Person Palliative Care'],"['length of stay in hospice', 'quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care', 'QOL, mood, and quality of communication with oncologists']","[{'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0242170', 'cui_str': 'Policy Makers'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",1250.0,0.0835891,"Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer.","[{'ForeName': 'Isaac S', 'Initials': 'IS', 'LastName': 'Chua', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Finly', 'Initials': 'F', 'LastName': 'Zachariah', 'Affiliation': 'City of Hope, Duarte, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dale', 'Affiliation': 'City of Hope, Duarte, California.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hanson', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Blackhall', 'Affiliation': 'University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Tammie', 'Initials': 'T', 'LastName': 'Quest', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Curseen', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Grey', 'Affiliation': 'Wake Forest Baptist Health, Winston-Salem, North Carolina.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Rhodes', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Shoemaker', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Silveira', 'Affiliation': 'Michigan Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'University of Colorado Hospital, Aurora, Colorado.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': ""O'Mahony"", 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Kostantinos', 'Initials': 'K', 'LastName': 'Leventakos', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Chardria', 'Initials': 'C', 'LastName': 'Trotter', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Sereno', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0210']
1537,32434001,Platelet activation and placenta-mediated adverse pregnancy outcomes: an ancillary study to the Effects of Aspirin in Gestation and Reproduction trial.,"BACKGROUND


Platelet activation may play a role in the pathophysiology of placenta-mediated obstetrical complications, as evidenced by the efficacy of aspirin in preventing preeclampsia, but published data regarding the relationship between biomarkers for platelet activation and adverse obstetrical outcomes are sparse. In particular, it is unknown whether prepregnancy biomarkers of platelet activation are associated with adverse pregnancy outcomes.
OBJECTIVE


This study aimed to determine the following: (1) whether maternal plasma concentrations of platelet factor 4 are associated with risk of placenta-mediated adverse obstetrical outcomes, and (2) whether these associations are modified by low-dose aspirin.
STUDY DESIGN


This ancillary study included measurement of platelet factor 4 among 1185 of 1228 women of reproductive age enrolled in the Effects of Aspirin in Gestation and Reproduction trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation. We measured platelet factor 4 in plasma samples obtained at the prepregnancy study visit (before randomization to low-dose aspirin or placebo), 12 weeks' gestation, and 28 weeks' gestation. The primary outcome was a composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational-age infant. We estimated the relative risks (RRs) and 95% confidence intervals (CIs) for the association between platelet factor 4 and the composite and individual outcomes at each time point using log-binomial regression that was weighted to account for potential selection bias and adjusted for age, body mass index, education, income, and smoking. To evaluate the potential effect modification of aspirin, we stratified the analyses by aspirin treatment assignment.
RESULTS


During follow-up, 95 women experienced the composite adverse obstetrical outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small for gestational age, and 6 of placental abruption. Overall, prepregnancy platelet factor 4 was positively associated with the composite outcome (third tertile vs first tertile; relative risk, 2.36; 95% confidence interval, 1.38-4.03) and with hypertensive disorders of pregnancy (third tertile vs first tertile; relative risk, 2.14; 95% confidence interval, 1.08-4.23). In analyses stratified by treatment group, associations were stronger in the placebo group (third tertile vs first tertile; relative risk, 3.36; 95% confidence interval, 1.42-7.93) than in the aspirin group (third tertile vs first tertile; relative risk, 1.78; 95% confidence interval, 0.90-3.50).
CONCLUSION


High concentrations of platelet factor 4 before pregnancy are associated with increased risk of placenta-mediated adverse pregnancy outcomes, particularly for hypertensive disorders of pregnancy. Aspirin may mitigate the increased risk of these outcomes among women with higher plasma concentrations of preconception platelet factor 4, but low-dose aspirin nonresponders may require higher doses of aspirin or alternate therapies to achieve obstetrical risk reduction.",2020,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[""1,185 of the 1,228 reproductive-age women enrolled in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation"", '95 women experienced the composite adverse obstetric outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small-for-gestational age (SGA), and 6 of placental abruption']","['Aspirin', 'aspirin', 'aspirin or placebo']","['composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational age neonate', 'hypertensive disorders of pregnancy', 'Platelet activation and placenta-mediated adverse pregnancy outcomes']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",584.0,0.178718,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Theilen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT. Electronic address: lauren.theilen@hsc.utah.edu.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Campbell', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Purdue-Smithe', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.026']
1538,31138588,"Safety, Efficacy, and Biomarker Analysis of Pyrotinib in Combination with Capecitabine in HER2-Positive Metastatic Breast Cancer Patients: A Phase I Clinical Trial.","PURPOSE


This phase I study assessed the safety, tolerability, MTD, pharmacokinetics, antitumor activity, and predictive biomarkers of pyrotinib, an irreversible pan-ErbB inhibitor, in combination with capecitabine in patients with HER2-positive metastatic breast cancer (MBC).
PATIENTS AND METHODS


Patients received oral pyrotinib 160 mg, 240 mg, 320 mg, or 400 mg once daily continually plus capecitabine 1,000 mg/m 2  twice daily on days 1 to 14 of a 21-day cycle. Pharmacokinetic blood samples were collected on days 1 and 14. Next-generation sequencing was performed on circulating tumor DNA to probe for predictive biomarkers.
RESULTS


A total of 28 patients were enrolled, 22 patients were treated at the two top-level doses. Among 17 (60.7%) trastuzumab-pretreated patients, 11 received trastuzumab for metastatic disease and 6 received adjuvant trastuzumab. No dose-limited toxicity was observed. Grade 3 treatment-related adverse events (AE) occurred in 12 (42.9%) patients; anemia (14.3%) and diarrhea (10.7%) were the most common grade 3 AEs. The overall response rate (ORR) was 78.6% [95% confidence interval (CI): 59.0%-91.7%], and the clinical benefit rate was 85.7% (95% CI: 67.3%-96.0%). The median progression-free survival (PFS) was 22.1 months (95% CI: 9.0-26.2 months). ORR was 70.6% (12/17) in trastuzumab-pretreated patients and 90.9% (10/11) in trastuzumab-naïve patients. Analysis of all genetic alterations in HER2-related signaling network in baseline blood samples suggested that multiple genetic alterations were significantly associated with poorer PFS compared with none or one genetic alteration (median, 16.8 vs. 29.9 months,  P  = 0.006).
CONCLUSIONS


In a population largely naïve to HER2-targeted therapy, pyrotinib in combination with capecitabine was well-tolerated and demonstrates promising antitumor activity in patients with HER2-positive MBC.",2019,The median progression-free survival(PFS) was 22.1 months(95% CI: 9.0 to 26.2 months).,"['patients with HER2-positive metastatic breast cancer(MBC', 'HER2-positive MBC patients', 'HER2-Positive Metastatic Breast Cancer Patients', 'A total of 28 patients were enrolled, 22 patients were treated at the two top-level doses']","['oral pyrotinib 160 mg, 240 mg, 320 mg, or 400 mg once daily continually plus capecitabine', 'adjuvant trastuzumab', 'capecitabine', 'Pyrotinib in Combination with Capecitabine', 'trastuzumab']","['median progression-free survival(PFS', 'overall response rate(ORR', 'clinical benefit rate', 'limited toxicity', 'Pharmacokinetic blood samples', 'safety, tolerability, maximum-tolerated dose, pharmacokinetics, antitumor activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",28.0,0.14233,The median progression-free survival(PFS) was 22.1 months(95% CI: 9.0 to 26.2 months).,"[{'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zongbi', 'Initials': 'Z', 'LastName': 'Yi', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Puyuan', 'Initials': 'P', 'LastName': 'Xing', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Dafang', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine Co., Ltd, Jiangsu, Nanjing, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Hengrui Medicine Co., Ltd, Jiangsu, Nanjing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. xubingheBM@163.com drmafei@126.com.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. xubingheBM@163.com drmafei@126.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-4173']
1539,30160499,"Abstinence and low risk drinking during treatment: Association with psychosocial functioning, alcohol use, and alcohol problems 3 years following treatment.","Abstinence from alcohol is often considered a critical element of recovery from alcohol use disorder. Yet, low risk drinking may be more desirable for some patients. There is mixed literature on whether low risk drinking is achievable and stable. Low risk drinking outcomes during treatment and outcomes 3 years after treatment were examined using data from the outpatient arm in Project MATCH (n = 877). Drinking outcomes were defined by repeated measures latent class analysis of weekly abstinence, low risk drinking days (<4/5 drinks for women/men), and heavy drinking days (≥4/5 drinks for women/men) during 12 weeks of treatment. Functioning outcome measures included psychosocial functioning, alcohol use, and alcohol-related consequences. Mixture modeling was used to examine the association between drinking classes and functioning outcomes. We identified 7 classes based on drinking during treatment: persistent heavy drinking, abstinence to heavy drinking, abstinence and heavy drinking, heavy drinking to mostly abstinent, low risk and heavy drinking, abstinence and low risk drinking, and abstinence. As compared with heavier drinkers, individuals who achieved mostly abstinence or low risk drinking, even with some heavy drinking episodes during treatment, had significant improvements in alcohol use, alcohol-related consequences, and psychosocial functioning 3 years after treatment. Those who were mostly abstinent or engaged in low risk drinking during treatment did not differ on any outcomes at 3 years after treatment. Findings indicate that low risk drinking is achievable for some individuals during treatment and that improvement in functioning among low risk drinkers can be observed at 3 years after treatment. (PsycINFO Database Record",2018,Those who were mostly abstinent or engaged in low risk drinking during treatment did not differ on any outcomes at 3 years after treatment.,"['7 classes based on drinking during treatment: persistent heavy drinking, abstinence to heavy drinking, abstinence and heavy drinking, heavy drinking to mostly abstinent, low risk and heavy drinking, abstinence and low risk drinking, and abstinence']",[],"['Abstinence and low risk drinking', 'alcohol use, alcohol-related consequences, and psychosocial functioning', 'Low risk drinking outcomes', 'psychosocial functioning, alcohol use, and alcohol-related consequences']","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]",[],"[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",877.0,0.0217965,Those who were mostly abstinent or engaged in low risk drinking during treatment did not differ on any outcomes at 3 years after treatment.,"[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kirouac', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Bravo', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Montes', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Department of Psychology.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000381']
1540,31408791,Can theta burst stimulation safely influence auditory hearing thresholds in healthy young adults?,"OBJECTIVE


This TBS sham-controlled study aimed to evaluate the effects of intermittent TBS (iTBS) and continuous TBS (cTBS) upon ipsilateral hearing thresholds after stimulation on the left auditory cortex.
METHODS


Sixty healthy adults, aged between 19 and 32 years (median of 23 years), were randomly distributed into three groups and underwent iTBS, cTBS or sham stimulation. Each double-blind experimental session comprised two pure tone audiometric evaluations per subject, before and after stimulation. To assess volunteer safety, a follow-up of at least 48 hours was implemented.
RESULTS


The iTBS group mean thresholds displayed a tendency to decrease after stimulation, predominantly in the 500 Hz-6000 Hz interval and group comparisons revealed significant differences between the iTBS and sham groups for 500 Hz (p = 0.041) and between the iTBS and cTBS groups for 4000 Hz (p = 0.038). Neither relevant side effects nor any significant hearing threshold impairment after active or sham stimulation were found.
CONCLUSIONS


A single stimulation session led to an effective neuromodulation of the auditory cortex, reflected in lower thresholds when using iTBS.
SIGNIFICANCE


These encouraging results with this safe noninvasive tool suggest that iTBS may have the potential to positively influence hearing thresholds.",2019,"The iTBS group mean thresholds displayed a tendency to decrease after stimulation, predominantly in the 500 Hz-6000 Hz interval and group comparisons revealed significant differences between the iTBS and sham groups for 500 Hz (p = 0.041) and between the iTBS and cTBS groups for 4000 Hz (p = 0.038).","['healthy young adults', 'Sixty healthy adults, aged between 19 and 32\u202fyears (median of 23\u202fyears']","['iTBS, cTBS or sham stimulation', 'intermittent TBS (iTBS) and continuous TBS (cTBS']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",[],60.0,0.0896543,"The iTBS group mean thresholds displayed a tendency to decrease after stimulation, predominantly in the 500 Hz-6000 Hz interval and group comparisons revealed significant differences between the iTBS and sham groups for 500 Hz (p = 0.041) and between the iTBS and cTBS groups for 4000 Hz (p = 0.038).","[{'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Pinto', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal; Dr. Lopes Dias School of Health - Polytechnic Institute of Castelo Branco, 6000-767, Portugal. Electronic address: nfcpinto@gmail.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Oliveira', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal. Electronic address: a30345@fcsaude.ubi.pt.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal. Electronic address: a21912@fcsaude.ubi.pt.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gama', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal; University of Beira Interior - Department of Mathematics, Covilhã 6200-506, Portugal. Electronic address: jgama@ubi.pt.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vaz Pato', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal; Sousa Martins Hospital, Guarda Local Health Unit, Guarda 6300-858, Portugal. Electronic address: mariavazpato@gmail.com.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2019.07.019']
1541,31478095,"The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study.","To evaluate the effect of high-intensity laser therapy (HILT) in patients with calcaneal spur. The patients were randomized to receive either HILT + exercise (n = 21) (five times a week for a period of 3 weeks) or placebo HILT + exercise (n = 21) (five times a week for a period of 3 weeks). Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS)), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement, and quality of life (with short form-36 (SF-36)) of the patients were evaluated at baseline, at 4 weeks, and 12 weeks. A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups. Besides, there was no significant difference in VAS (p > 0.05) and RMS (p > 0.05) between the groups. FAOS symptoms (p = 0.022) and quality of life (p = 0.038) subgroups were higher in the placebo group at 12 weeks. Significant improvements were observed in dynamic pedographic measurements in the HILT group (p < 0.05), and dynamic measurement values were significantly higher in the HILT group compared to placebo group (p < 0.05). Although the evaluation parameters, except dynamic pedographic measurements, have improved in both groups, our study results showed no superiority of HILT over placebo. To conclude, when the main complaint is pain in patients, only exercise therapy can be an economical, practical, and reliable treatment.",2020,"A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups.","['painful calcaneal spur', 'patients with calcaneal spur']","['HILT\u2009+\u2009exercise', 'HILT', 'high-intensity laser therapy (HILT', 'placebo', 'high intensity laser therapy', 'placebo HILT\u2009+\u2009exercise']","['FAOS subgroup scores', 'FAOS symptoms', 'SF-36 subgroup scores', 'Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS)), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement, and quality of life (with short form-36 (SF-36', 'quality of life', 'VAS', 'dynamic measurement values', 'RMS', 'dynamic pedographic measurements']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal Spur'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.201732,"A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups.","[{'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Yesil', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey. dradanur@yahoo.com.'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Dundar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Toktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Nuran', 'Initials': 'N', 'LastName': 'Eyvaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Yeşil', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}]",Lasers in medical science,['10.1007/s10103-019-02870-w']
1542,31450138,Less memory complaints with reduced stimulus dose during electroconvulsive therapy for depression.,"BACKGROUND


Electroconvulsive therapy (ECT) is an effective treatment for depression, but there is risk of cognitive adverse events. This risk has been partially attributed to electrical charge, thus the optimal electrical stimulus dose is still under discussion. The aim of this study was to evaluate how the risk of subjective memory worsening was changed after lowering stimulus dose during ECT for patients with major depression.
METHOD


A retrospective register-based intervention study of the effects of reduced electrical charges for patients receiving ECT for depression was conducted. The primary outcome was subjective memory worsening and the secondary outcome change in effect on depressive symptoms.
RESULTS


A total of 154 patients were enrolled in the study (High dosage group: n = 57; Lower dosage group: n = 97). Subjective memory worsening after ECT occurred in 44% of patients in the high dosage group and in 25% of patients in the lower dosage group(p = 0.014). There was no significant between-group difference in the anti-depressive effect of ECT.
LIMITATIONS


The study was register-based and the two groups were not randomized. A large portion of patients were initially excluded due to missing data in the register. The study lacks a long-term follow up.
CONCLUSION


After implementing a change of treatment protocol, that lowered ECT stimulus doses from high to moderate, the occurrence of subjective memory worsening was significantly reduced without compromising treatment results.",2019,Subjective memory worsening after ECT occurred in 44% of patients in the high dosage group and in 25% of patients in the lower dosage group(p = 0.014).,"['154 patients were enrolled in the study (High dosage group: n\u202f=\u202f57; Lower dosage group: n\u202f=\u202f97', 'patients receiving ECT for depression was conducted', 'patients with major depression']","['Electroconvulsive therapy (ECT', 'electroconvulsive therapy']","['Subjective memory worsening after ECT', 'depressive symptoms', 'subjective memory worsening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",154.0,0.048525,Subjective memory worsening after ECT occurred in 44% of patients in the high dosage group and in 25% of patients in the lower dosage group(p = 0.014).,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kronsell', 'Affiliation': 'Psykiatri Nordväst, Stockholm County Council. Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm County Council. Centrum för psykiatriforskning, Norra Stationsgatan 69, SE-113 64 Stockholm, Sweden. Electronic address: alexander.kronsell@sll.se.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Nordenskjöld', 'Affiliation': 'Faculty of Medicine and Health, Örebro University.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Tiger', 'Affiliation': 'Department of Clinical Neuroscience, Center for Psychiatry Research, Karolinska Institutet and Stockholm County Council.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.064']
1543,31502420,A novel approach to improve stress regulation among traumatized youth in residential care: Feasibility study testing three game-based meditation interventions.,"AIM


Many youth in residential care suffer from post-traumatic symptoms that have adverse effects on a range of psychological, behavioural and physiological outcomes. Although current evidence-based treatment options are effective, they have their limitations. Meditation interventions are an alternative to traditional trauma-focused treatment. This pilot study aimed to evaluate three game-based meditation interventions in a sample of traumatized youth in residential care.
METHODS


Fifteen participants were randomly divided over three conditions (Muse, DayDream and Wild Divine) that all consisted of twelve 15-minute game-play sessions. Physiological measurements (heart rate variability) were conducted at baseline, post-treatment and during each intervention session. Post-traumatic symptoms, stress, depression, anxiety and aggression were assessed at baseline, post-treatment and 1-month follow-up.
RESULTS


Physiological stress regulation was improved during the meditation sessions of all three interventions. User evaluations were in particular high for Muse with a rating of 8.42 out of 10 for game evaluation. Overall, outcomes on psychopathology demonstrated the most robust effect on stress. Muse performed best, with all participants showing reliable improvements (reliable change indexes [RCIs]) in post-traumatic symptoms, stress and anxiety. Participants who played Daydream or Wild Divine showed inconsistent progression: some participants improved, whereas others remained stable or even deteriorated based on their RCIs.
CONCLUSIONS


Preliminary findings show promising outcomes on physiology, psychopathology and user evaluations. All indicate the potential of this innovative form of stress regulation intervention, and the potential of Muse in particular, although findings should be considered preliminary due to our small sample size. Further studies are warranted to assess intervention effectiveness effects of Muse or other game-based meditation interventions for traumatized youth.",2020,"Muse performed best, with all participants showing reliable improvements (reliable change indexes [RCIs]) in post-traumatic symptoms, stress and anxiety.","['traumatized youth in residential care', 'traumatized youth', 'Fifteen participants']","['Muse or other game-based meditation interventions', 'game-based meditation interventions', 'Meditation interventions']","['Physiological measurements (heart rate variability', 'progression', 'traumatic symptoms, stress and anxiety', 'stress regulation', 'Post-traumatic symptoms, stress, depression, anxiety and aggression']","[{'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C2366566', 'cui_str': 'Muse'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150277'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}]",15.0,0.0408452,"Muse performed best, with all participants showing reliable improvements (reliable change indexes [RCIs]) in post-traumatic symptoms, stress and anxiety.","[{'ForeName': 'Angela A T', 'Initials': 'AAT', 'LastName': 'Schuurmans', 'Affiliation': 'Research & Development, Pluryn, Nijmegen, the Netherlands.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Nijhof', 'Affiliation': 'Research & Development, Pluryn, Nijmegen, the Netherlands.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Scholte', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Popma', 'Affiliation': 'Department of Child and Adolescent Psychiatry, VUmc/De Bascule, Amsterdam, the Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Research & Development, Pluryn, Nijmegen, the Netherlands.'}]",Early intervention in psychiatry,['10.1111/eip.12874']
1544,31390617,Is Mindfulness-Based Stress Reduction a Promising and Feasible Intervention for Patients Suffering from Migraine? A Randomized Controlled Pilot Trial.,"AIM


We performed a pilot study in order to evaluate the feasibility and to estimate effect sizes of mindfulness-based stress reduction (MBSR) in a sample of patients suffering from migraine.
METHOD


Migraine patients (n = 62, mean age 44 years, 92% female) were randomly allocated to either MBSR or an active control intervention based on progressive muscle relaxation and psychoeducation. The primary outcome was the number of migraine days per month assessed by headache diaries covering one month before and one month after the intervention. Secondary outcomes included functional impairment, use of medication, psychological symptoms, quality of life, pain acceptance, pain self-efficacy, pain perception and self-attributed mindfulness. To measure feasibility, questionnaires assessing study compliance and contentment were administered.
RESULTS


The primary outcome migraine frequency showed no significant group difference. Compared to the control group, the MBSR group showed greater improvements in variables of psychological symptoms, pain self-efficacy and sensory pain perception. Within the MBSR condition, all variables showed significant improvements over the course span with effect sizes ranging from d = 0.37 to 0.81, apart from the primary outcome (27% reduction in migraine days, p = 0.07). Compliance and contentment rates were good, supporting the feasibility of the MBSR intervention.
CONCLUSION


Overall, participants in the MBSR group showed more adaptive coping strategies and decreased levels of psychological impairment compared to the control group, indicating a reduced impact of migraine on their everyday lives. It is concluded that this feasibility study demonstrates the ability of mindfulness-based interventions to reduce suffering in patients with migraine.",2020,"Overall, participants in the MBSR group showed more adaptive coping strategies and decreased levels of psychological impairment compared to the control group, indicating a reduced impact of migraine on their everyday lives.","['patients with migraine', 'Migraine patients (n = 62, mean age 44 years, 92% female', 'Patients Suffering from Migraine', 'patients suffering from migraine']","['mindfulness-based stress reduction (MBSR', 'MBSR or an active control intervention based on progressive muscle relaxation and psychoeducation', 'MBSR']","['levels of psychological impairment', 'psychological symptoms, pain self-efficacy and sensory pain perception', 'adaptive coping strategies', 'number of migraine days per month assessed by headache diaries', 'functional impairment, use of medication, psychological symptoms, quality of life, pain acceptance, pain self-efficacy, pain perception and self-attributed mindfulness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0556971', 'cui_str': 'days/month (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",,0.029808,"Overall, participants in the MBSR group showed more adaptive coping strategies and decreased levels of psychological impairment compared to the control group, indicating a reduced impact of migraine on their everyday lives.","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Simshäuser', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lüking', 'Affiliation': 'Interdisciplinary Pain Center, Medical Faculty, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Kaube', 'Affiliation': 'Interdisciplinary Pain Center, Medical Faculty, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schultz', 'Affiliation': 'University Center for Complementary Medicine, Medical Faculty, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Medical Center, University of Freiburg, Freiburg, Germany, stefan.schmidt@uniklinik-freiburg.de.'}]",Complementary medicine research,['10.1159/000501425']
1545,31476757,The Effect of Resin Infiltration on the Progression of Proximal Caries Lesions: A Randomized Clinical Trial.,"OBJECTIVE


The aim of this clinical trial was to assess the effect of resin infiltration on the progression of proximal caries lesions.
SUBJECTS AND METHODS


Forty-one patients, aged between 15 and 33 years, with 2 or more non-cavitated proximal caries lesions were included. In 41 of the adolescent and young adults, 45 pairs of proximal lesions with radiological extension into the inner and outer half of the enamel, or into the outer third of the dentin, were randomly allocated to the test groups (resin infiltration application + fluoridated toothpaste and flossing use) or to the control group (fluoridated toothpaste and flossing use). Standardized geometrically aligned digital bitewing radiographs were obtained using individual biting holders. The radiographic progression of the lesions was assessed after 1 year by digital-subtraction radiography. The McNemar test was used for statistical analysis.
RESULTS


In the test group 1/45 of the lesions (2.2%) and in the control group 9/45 of the lesions (20%) showed progression. The caries progression rate of the control group was significantly higher than that of the test group (p < 0.05).
CONCLUSIONS


Resin infiltration of proximal caries lesions is effective in reducing progression of the lesion.",2020,"The caries progression rate of the control group was significantly higher than that of the test group (p< 0.05).
","['In 41 of the adolescent and young adults 45 pairs of proximal lesions with radiological extension into the inner and outer half of the enamel, or into the outer third of the dentin', 'Forty-one patients, aged 15 to 33 years, with 2 or more non-cavitated proximal caries lesions were included']","['test groups (resin infiltration application + fluoridated toothpaste and flossing use) or to the control group (fluoridated toothpaste and flossing use', 'resin infiltration', 'Resin Infiltration']","['radiographic progression of the lesions', 'caries progression rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}]",41.0,0.0412558,"The caries progression rate of the control group was significantly higher than that of the test group (p< 0.05).
","[{'ForeName': 'Soley', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Erciyes University, Kayseri, Turkey, soley@erciyes.edu.tr.'}, {'ForeName': 'Melek Hilal', 'Initials': 'MH', 'LastName': 'Kaplan', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000503053']
1546,10876850,[A cultured concentrated inactivated vaccine against tick-borne encephalitis studied during the immunization of children and adolescents].,"The word deals with the results obtained in the study of the reactogenicity and immunological activity of concentrated and inactivated tissue-culture tick-borne encephalitis vaccine, manufactured by the Chumakov Institute of Poliomyelitis and Viral Encephalitides, in the immunization of children and adolescents. The vaccine proved to be moderately reactogenic and exhibited pronounced immunological activity. In 91.5% of the immunized children the fourfold increase of the antibody level was observed. On the basis of the data obtained in this study the tick-borne encephalitis vaccine was recommended for use in medical practice for the prophylaxis of tick-borne encephalitis among children and adolescents.",1999,In 91.5% of the immunized children the fourfold increase of the antibody level was observed.,['children and adolescents'],[],"['antibody level', 'immunological activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.014468,In 91.5% of the immunized children the fourfold increase of the antibody level was observed.,"[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Pavlova', 'Affiliation': 'Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations, Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gorbunov', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': ""Vorob'eva"", 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Karavanov', 'Affiliation': ''}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Grachev', 'Affiliation': ''}, {'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Ladyshenskaia', 'Affiliation': ''}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Rasshchepkina', 'Affiliation': ''}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': ""Mel'nikova"", 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Lebedeva', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': ""Mel'nikov"", 'Affiliation': ''}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Gusmanova', 'Affiliation': ''}, {'ForeName': 'M Iu', 'Initials': 'MIu', 'LastName': 'Deviatkov', 'Affiliation': ''}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Rozanova', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mukachev', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1547,30889093,The effect of a randomized 12-week soy drink intervention on everyday mood in postmenopausal women.,"OBJECTIVE


Dietary soy may improve menopausal symptoms, and subsequently mediate mood. This novel study examines various doses of dietary soy drink on everyday mood stability and variability in postmenopausal women.
METHODS


Community-dwelling women (n = 101), within 7 years postmenopause, consumed daily either a low (10 mg, n = 35), medium (35 mg, n = 37), or high (60 mg, n = 29) dose of isoflavones, for 12 weeks. Menopausal symptoms and repeated measures of everyday mood (positive [PA] and negative [NA] affect) (assessed at four time points per day for 4 consecutive days, using The Positive and Negative Affect Schedule) were completed at baseline and follow-up.
RESULTS


The dietary soy intervention had no effect on everyday mood stability (for PA [F{2,70} = 0.95, P = 0.390] and NA [F{2,70} = 0.72, P = 0.489]) or variability (for PA [F{2,70} = 0.21, P = 0.807] and for NA [F{2,70} = 0.15, P = 0.864]), or on menopausal symptoms (for vasomotor [F{2,89} = 2.83, P = 0.064], psychological [F{2,88} = 0.63, P = 0.535], somatic [F{2,89} = 0.32, P = 0.729], and total menopausal symptoms [F{2,86} = 0.79, P = 0.458]). There were between-group differences with the medium dose reporting higher PA (low, mean 24.2, SD 6; and medium, mean 29.7, SD 6) and the low dose reporting higher NA (P = 0. 048) (low, mean 11.6, SD 2; and high, mean 10.6, SD 1) in mood scores. Psychological (baseline M = 18 and follow-up M = 16.5) and vasomotor (baseline M = 4.2 and follow-up M = 3.6) scores declined from baseline to follow-up for the overall sample.
CONCLUSIONS


Soy isoflavones had no effect on mood at any of the doses tested. Future research should focus on the menopause transition from peri to postmenopause as there may be a window of vulnerability, with fluctuating hormones and increased symptoms which may affect mood.",2019,"The dietary soy intervention had no effect on everyday mood stability (for PA [F{2,70} = 0.95, P = 0.390] and","['postmenopausal women', 'Community-dwelling women (n\u200a=\u200a101), within 7 years postmenopause', '048']","['soy drink intervention', 'dietary soy intervention', 'dietary soy drink', 'isoflavones', 'Soy isoflavones']","['everyday mood stability', 'menopausal symptoms', 'total menopausal symptoms', 'everyday mood', 'Menopausal symptoms and repeated measures of everyday mood (positive [PA] and negative [NA']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206159', 'cui_str': 'Post-menopausal Period'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone (substance)'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.20664,"The dietary soy intervention had no effect on everyday mood stability (for PA [F{2,70} = 0.95, P = 0.390] and","[{'ForeName': 'Ellen E A', 'Initials': 'EEA', 'LastName': 'Simpson', 'Affiliation': 'Psychology Research Institute, Ulster University, UK.'}, {'ForeName': 'Orlaith N', 'Initials': 'ON', 'LastName': 'Furlong', 'Affiliation': 'Nutrition Innovation Centre for Food and Health, Ulster University, UK.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Parr', 'Affiliation': 'Norwich Medical School, University of East Anglia, UK.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Hodge', 'Affiliation': 'Nutrition Innovation Centre for Food and Health, Ulster University, UK.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Slevin', 'Affiliation': 'Nutrition Innovation Centre for Food and Health, Ulster University, UK.'}, {'ForeName': 'Emeir M', 'Initials': 'EM', 'LastName': 'McSorley', 'Affiliation': 'Nutrition Innovation Centre for Food and Health, Ulster University, UK.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McCormack', 'Affiliation': 'Faculty of Science, Sligo Institute of Technology, Ireland, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McConville', 'Affiliation': 'Psychology Research Institute, Ulster University, UK.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Magee', 'Affiliation': 'Nutrition Innovation Centre for Food and Health, Ulster University, UK.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001322']
1548,31831270,The effect of acupressure on quality of life among female nurses with chronic back pain.,"BACKGROUND


Chronic back pain is one of the most common work-related diseases and most important of musculoskeletal disorders in nursing professionals and because of the physical and psychological effects, has a significant impact on quality of life (QOL). Acupressure is a holistic form of complementary medicine. This study aimed to investigate the effect of acupressure on QOL among female nurses with chronic back pain.
MATERIALS AND METHODS


This randomized single-blind clinical trial was conducted on 50 nurses with chronic back pain working at the selected hospitals in Isfahan, Iran. After convenient sampling, the subjects were randomly allocated, through lottery, to the two groups of experimental (n = 25) and sham (n = 25). In the experimental group, acupressure techniques were performed during 9 sessions, 3 times a week for 14 min for each patient. In the sham group, points within 1 cm of the main points were only touched. Data were collected using the SF36 questioner, before, and immediately, 2 weeks, and 4 weeks after the intervention. Data analysis was performed using SPSS software.
RESULTS


Independent t-test showed that the mean total score of QOL before the intervention was not significantly different between the two groups before the intervention (P = .68). However, it was significantly higher in the experimental group compared to the Sham group, immediately, 2 weeks, and 1 month after the intervention (P < .001).
CONCLUSIONS


Acupressure on specific points of the foot and back improves back pain and as a result, increases QOL. Therefore, acupressure can be used as a drug-free and low-cost approach without side effects to improve QOL in nurses with chronic back pain.",2020,"RESULTS


Independent t-test showed that the mean total score of QOL before the intervention was not significantly different between the two groups before the intervention (P = .68).","['50 nurses with chronic back pain working at the selected hospitals in Isfahan, Iran', 'nurses with chronic back pain', 'female nurses with chronic back pain']","['Acupressure', 'acupressure']","['quality of life', 'QOL', 'back pain', 'quality of life (QOL', 'mean total score of QOL']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.067822,"RESULTS


Independent t-test showed that the mean total score of QOL before the intervention was not significantly different between the two groups before the intervention (P = .68).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Movahedi Najafabadi', 'Affiliation': 'Nursing group, Faculty of Paramedical Sciences,Islamic azad university, Aligudarz branch, Lorestan, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ghafari', 'Affiliation': 'Nursing and Midwifery care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nazari', 'Affiliation': 'Adult Health Nursing Dept., Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Valiani', 'Affiliation': 'Nursing and Midwifery care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.05.020']
1549,31935026,Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,"Importance


Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data.
Objective


To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer.
Design, Setting, and Participants


The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017.
Interventions


Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241).
Main Outcomes and Measures


The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy.
Results


Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]).
Conclusions and Relevance


Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT01238172.",2020,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","['Men', '64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis', 'men with early-stage prostate cancer', 'men with early-stage prostate cancer managed with active surveillance', ""Participants\n\n\nThe Men's Eating and Living (MEAL) Study (CALGB 70807"", 'With Early-Stage Prostate Cancer', '478 patients randomized (mean [SD] age', '91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group\u2009=\u20091 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level', 'prostate cancer survivors']","['Guidelines endorsing vegetable-enriched diets', 'counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n\u2009=\u2009237) or a control group, which received written information about diet and prostate cancer (n\u2009=\u2009241', 'behavioral intervention that increased vegetable intake', 'Behavioral Intervention to Increase Vegetable Consumption']","['time to progression; progression', 'Cancer Progression', 'PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade', 'cancer progression', '24-month Kaplan-Meier progression-free percentages', 'time to progression', 'risk of prostate cancer progression', 'prostate cancer progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",478.0,0.259409,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","[{'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Hansel', 'Affiliation': 'Department of Pathology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Stroup', 'Affiliation': 'Department of Urology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Veldhuizen', 'Affiliation': 'Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.'}, {'ForeName': 'Lannis', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",JAMA,['10.1001/jama.2019.20207']
1550,30882166,Effect of Irrigation Solution Temperature on Complication of Percutaneous Nephrolithotomy: A Randomized Clinical Trial.,"PURPOSE


Many factors affecthypothermia and shivering during percutaneous nephrolithotomy and in recovery.Hence this study was carried out to determine the effect of irrigation solution temperature on complications ofpercutaneous nephrolithotomy.
MATERIALS AND METHODS


In this randomized clinical trial, 60 patients undergoing PCNL in Sina University Hospitalwere enrolled. The patients were randomly assigned in three groups according to simple random manner. Thegroups included three groups of room temperature fluid (24 degree), warm solution (37 degree), and cold fluid (20degree) during nephroscopy.
RESULTS


Although the initial core temperature was alike across the groups (P > .05); the hypothermia rate occuredin all 20 patients in the cold fluid group (P = .012). There was significant difference between the groups interms of final temperature and alteration amount (P = .001). The mean VAS scores were significantly lower in thewarm fluid group compared with the others groups at recovery, and 8hrs post-operatively (P = .03). Assessmentof shivering rates revealed that 3(15%) patients in warm solution group shivered compared to8 (40%) patients incold fluid group (P = .018).
CONCLUSION


Warm irrigation solution during PCNL results in significantly decreased hypothermia, mean postoperativepain score and shivering. Hence use of warm irrigation fluid for this matter is recommended.",2019,"The mean VAS scores were significantly lower in warm fluid group compared with the others groups at the recovery, and 8 h postoperatively (P = 0.03).",['60 patients under PCNL in Sina University Hospital were enrolled'],"['percutaneous nephrolithotomy', 'irrigation solution temperature', 'Irrigation Solution Temperature']","['hypothermia rate', 'shivering rates', 'mean VAS scores', 'hypothermia, the mean postoperative pain score and shivering', 'Complication of Percutaneous Nephrolithotomy', 'final temperature and alteration amount']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C2746010', 'cui_str': 'Irrigating solution'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",60.0,0.0647947,"The mean VAS scores were significantly lower in warm fluid group compared with the others groups at the recovery, and 8 h postoperatively (P = 0.03).","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Hosseini', 'Affiliation': 'Department of Urology, Tehran University of Medical Sciences ,Tehran, Iran. rhosseinim@yahoo.com.'}, {'ForeName': 'Mohammad Ghasem', 'Initials': 'MG', 'LastName': 'Mohseni', 'Affiliation': 'Department of Urology, Tehran University of Medical Sciences ,Tehran, Iran. Email: mgmohseni@tums.ac.ir.'}, {'ForeName': 'Seyed Mohammad Kazem', 'Initials': 'SMK', 'LastName': 'Aghamir', 'Affiliation': 'Department of Urology, Tehran University of Medical Sciences, Tehran, Iran. Email: smkaghamir@yahoo.com.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Rezaei', 'Affiliation': 'Resident of Urology, Tehran University of Medical Sciences ,Tehran, Iran. hamed109@gmail.com.'}]",Urology journal,['10.22037/uj.v0i0.4399']
1551,31445343,Bipolar depression and suicidal ideation: Moderators and mediators of a complex relationship.,"INTRODUCTION


Not all patients with bipolar depression have suicidal ideation (SI). This study examines some factors that link bipolar depression to SI.
METHODS


482 individuals with bipolar I or II were randomized to either lithium or quetiapine plus adjunctive personalized therapy in a 24 week comparative effectiveness trial. Severity of depression and SI were assessed with the Bipolar Inventory of Symptoms Scale (BISS). We examined potential moderators (age, gender, age of illness onset, bipolar type, comorbid anxiety, substance use, past suicide attempts, childhood abuse and treatment arm) and mediators (severity of anxiety, mania, irritability, impairment in functioning (LIFE-RIFT) and satisfaction and enjoyment of life (Q-LES-Q)) of the effect of depression on SI. Statistical analyses were conducted using generalized estimating equations with repeated measures.
RESULTS


Bipolar type and past suicide attempts moderated the effect of depression on SI. Life satisfaction mediated the effect of depression and SI. The relationship between anxiety, depression and SI was complex due to the high level of correlation. Treatment with lithium or quetiapine did not moderate the effect of depression on SI.
LIMITATIONS


Suicide assessment was only done using an item on BISS. Patient population was not specifically chosen for high suicide risk.
DISCUSSION


Individuals with Bipolar II experienced more SI with lower levels of depression severity. A history of suicide predisposed patients to higher levels of SI given the same severity of depression. Reduced life satisfaction mediates the effect of depression on SI and may be a target for therapeutic interventions.",2019,"Treatment with lithium or quetiapine did not moderate the effect of depression on SI.
","['patients with bipolar depression have suicidal ideation (SI', '482 individuals with bipolar I or II']","['lithium or quetiapine plus adjunctive personalized therapy', 'lithium or quetiapine']","['mediators (severity of anxiety, mania, irritability, impairment in functioning (LIFE-RIFT) and satisfaction and enjoyment of life (Q-LES-Q', 'Bipolar Inventory of Symptoms Scale (BISS', 'depression on SI', 'Severity of depression and SI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}]","[{'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424131', 'cui_str': 'Enjoyment of life (observable entity)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",482.0,0.0495685,"Treatment with lithium or quetiapine did not moderate the effect of depression on SI.
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States. Electronic address: mkamali@mgh.harvard.edu.'}, {'ForeName': 'Noreen A', 'Initials': 'NA', 'LastName': 'Reilly-Harrington', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Weilynn C', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati OH and Lindner Center of HOPE, Mason, OH, United States.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, United States.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, United States.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, United States.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Kinrys', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Brody', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, United States.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Rabideau', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.032']
1552,31392790,Exercise-induced hypoalgesia in young adult females with long-standing patellofemoral pain - A randomized crossover study.,"BACKGROUND


Patellofemoral pain (PFP) is a common knee pain condition where hip and knee exercises help improve treatment outcomes. This study compared the acute effect of hip versus knee exercises on anti-nociceptive and pro-nociceptive mechanisms in young females with long-standing PFP.
METHODS


In this randomized cross-over study, 29 females with PFP performed hip and knee exercises in randomized order during a single day. Pressure pain thresholds (PPTs) were assessed by handheld pressure algometry at the patella, the tibialis anterior muscle, and the contralateral elbow. Cuff pressure algometry at the lower legs was used to assess pain detection threshold (cPDT) and tolerance (cPTT) as well as conditioned pain modulation (CPM: change in cPDT during contralateral cuff pain conditioning) and temporal summation of pain (TSP: ten painful cuff stimulations assessed on a visual analogue scale [VAS]).
RESULTS


PPTs at the tibialis anterior muscle but not at the patella increased compared with baseline following both exercises (p < .002). Compared with baseline, the cPDTs and cPTTs increased after both types of exercises (p < .001). The cPTTs increased more after knee compared to hip exercises (p < .007). VAS scores for TSP were increased following hip exercises (p < .001) although the rate of VAS increase over repeated stimulations was not significantly affected by exercises. The CPM-effect was reduced after both types of exercises (p < .001).
CONCLUSION


A general hypoalgesic response to slowly increasing pressure stimuli was observed following both hip and knee exercises as well as decreased conditioned pain modulation, potentially indicating an attenuated ability from exercise to inhibit pain.",2019,"Compared with baseline, the cPDTs and cPTTs increased after both types of exercises (p < .001).","['young adult females with long-standing patellofemoral pain ', 'young females with long-standing PFP', '29 females with']","['Exercise-induced hypoalgesia', 'PFP performed hip and knee exercises', 'hip versus knee exercises']","['rate of VAS increase', 'VAS scores for TSP', 'Pressure pain thresholds (PPTs', 'CPM-effect', 'Cuff pressure algometry', 'pain detection threshold (cPDT) and tolerance (cPTT', 'conditioned pain modulation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises (regime/therapy)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0443999,"Compared with baseline, the cPDTs and cPTTs increased after both types of exercises (p < .001).","[{'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Straszek', 'Affiliation': 'Center for General Practice at Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Center for General Practice at Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Kristian K', 'Initials': 'KK', 'LastName': 'Petersen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Ewa M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Holden', 'Affiliation': 'Center for General Practice at Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1452']
1553,31965140,"Association of egg intake with blood lipids, cardiovascular disease, and mortality in 177,000 people in 50 countries.","BACKGROUND


Eggs are a rich source of essential nutrients, but they are also a source of dietary cholesterol. Therefore, some guidelines recommend limiting egg consumption. However, there is contradictory evidence on the impact of eggs on diseases, largely based on studies conducted in high-income countries.
OBJECTIVES


Our aim was to assess the association of egg consumption with blood lipids, cardiovascular disease (CVD), and mortality in large global studies involving populations from low-, middle-, and high-income countries.
METHODS


We studied 146,011 individuals from 21 countries in the Prospective Urban Rural Epidemiology (PURE) study. Egg consumption was recorded using country-specific validated FFQs. We also studied 31,544 patients with vascular disease in 2 multinational prospective studies: ONTARGET (Ongoing Telmisartan Alone and in Combination with Ramipril Global End Point Trial) and TRANSCEND (Telmisartan Randomized Assessment Study in ACEI Intolerant Subjects with Cardiovascular Disease). We calculated HRs using multivariable Cox frailty models with random intercepts to account for clustering by study center separately within each study.
RESULTS


In the PURE study, we recorded 14,700 composite events (8932 deaths and 8477 CVD events). In the PURE study, after excluding those with history of CVD, higher intake of egg (≥7 egg/wk compared with <1 egg/wk intake) was not significantly associated with blood lipids, composite outcome (HR: 0.96; 95% CI: 0.89, 1.04; P-trend = 0.74), total mortality (HR: 1.04; 95% CI: 0.94, 1.15; P-trend = 0.38), or major CVD (HR: 0.92; 95% CI: 0.83, 1.01; P-trend = 0.20). Similar results were observed in ONTARGET/TRANSCEND studies for composite outcome (HR 0.97; 95% CI: 0.76, 1.25; P-trend = 0.09), total mortality (HR: 0.88; 95% CI: 0.62, 1.24; P-trend = 0.55), and major CVD (HR: 0.97; 95% CI: 0.73, 1.29; P-trend = 0.12).
CONCLUSIONS


In 3 large international prospective studies including ∼177,000 individuals, 12,701 deaths, and 13,658 CVD events from 50 countries in 6 continents, we did not find significant associations between egg intake and blood lipids, mortality, or major CVD events. The ONTARGET and TRANSCEND trials were registered at clinicaltrials.gov as NCT00153101. The PURE trial was registered at clinicaltrials.gov as NCT03225586.",2020,"Similar results were observed in ONTARGET/TRANSCEND studies for composite outcome (HR 0.97; 95% CI: 0.76, 1.25; P-trend = 0.09), total mortality (HR: 0.88; 95% CI: 0.62, 1.24; P-trend = 0.55), and major CVD (HR: 0.97; 95% CI: 0.73, 1.29; P-trend = 0.12).
","['ACEI Intolerant Subjects with Cardiovascular Disease', '177,000 people in 50 countries', '146,011 individuals from 21 countries in the Prospective Urban Rural Epidemiology (PURE) study', '∼177,000 individuals, 12,701 deaths, and 13,658 CVD events from 50 countries in 6 continents', '31,544 patients with vascular disease in 2 multinational prospective studies']",['ONTARGET (Ongoing Telmisartan Alone and in Combination with Ramipril Global End Point Trial) and TRANSCEND (Telmisartan'],"['blood lipids, composite outcome', 'egg intake and blood lipids, mortality, or major CVD events', 'total mortality', 'Egg consumption', 'egg consumption with blood lipids, cardiovascular disease (CVD), and mortality']","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0556195', 'cui_str': 'Egg intake'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",146011.0,0.528705,"Similar results were observed in ONTARGET/TRANSCEND studies for composite outcome (HR 0.97; 95% CI: 0.76, 1.25; P-trend = 0.09), total mortality (HR: 0.88; 95% CI: 0.62, 1.24; P-trend = 0.55), and major CVD (HR: 0.97; 95% CI: 0.73, 1.29; P-trend = 0.12).
","[{'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mente', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sumathy', 'Initials': 'S', 'LastName': 'Rangarajan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Gopalapuram, Chennai, India.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lear', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Sumathi', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': ""Division of Nutrition, St John's Research Institute, Koramangala, Bangalore, India.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Seron', 'Affiliation': 'Faculty of Medicine, University of La Frontera, Temuco, Chile.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'FOSCAL, Medical School, University of Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Ginette', 'Initials': 'G', 'LastName': 'Turbide', 'Affiliation': 'Heart and Lung Institute, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jephat', 'Initials': 'J', 'LastName': 'Chifamba', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Khalid F', 'Initials': 'KF', 'LastName': 'AlHabib', 'Affiliation': 'Department of Cardiac Sciences, King Fahad Cardiac Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Mohammadifard', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Szuba', 'Affiliation': 'Division of Angiology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Khatib', 'Affiliation': 'Institute for Community and Public Health, Birzeit University, Birzeit, Palestine.'}, {'ForeName': 'Yuksel', 'Initials': 'Y', 'LastName': 'Altuntas', 'Affiliation': 'Clinic of Endocrinology and Metabolism Sisli, Istanbul Sisli Hamidiye Etfal Health Training and Research Hospital, Faculty of Medicine, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Romaina', 'Initials': 'R', 'LastName': 'Iqbal', 'Affiliation': 'Department of Community Health Sciences and Medicine, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Rosengren', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, and Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Yusuf', 'Affiliation': 'School of Life Sciences, Independent University, Dhaka, Bangladesh.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Smuts', 'Affiliation': 'Centre of Excellence\xa0for Nutrition, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'AfzalHussein', 'Initials': 'A', 'LastName': 'Yusufali', 'Affiliation': 'Hatta Hospital, Dubai Medical University, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Qingshan Lake Community Health Service Center, Nanchang City, China.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Clinical Studies Latin America, Rosario, Santa Fe, Argentina.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': 'Department of Medicine, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Manmeet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, School of Public Health, Chandigarh, India.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Soman', 'Affiliation': 'Health Action by People, Thiruvananthapuram, India.'}, {'ForeName': 'Noorhassim', 'Initials': 'N', 'LastName': 'Ismail', 'Affiliation': 'Department of Community Health, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Eternal Heart Care Centre & Research Institute, Jaipur, India.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dans', 'Affiliation': 'Department of Medicine, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sheridan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Koon', 'Initials': 'K', 'LastName': 'Teo', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz348']
1554,31087608,"Mechanisms underlying the cardiometabolic protective effect of walnut consumption in obese people: A cross-over, randomized, double-blind, controlled inpatient physiology study.","AIMS


To assess the effects of walnuts on cardiometabolic outcomes in obese people and to explore the underlying mechanisms using novel methods including metabolomic, lipidomic, glycomic and microbiome analysis, integrated with lipid particle fractionation, appetite-regulating hormones and haemodynamic measurements.
MATERIALS AND METHODS


A total of 10 obese individuals were enrolled in this cross-over, randomized, double-blind, placebo-controlled clinical trial. The participants had two 5-day inpatient stays, during which they consumed a smoothie containing 48 g walnuts or a macronutrient-matched placebo smoothie without nuts, with a 1-month washout period between the two visits.
RESULTS


Walnut consumption improved aspects of the lipid profile; it reduced fasting small and dense LDL particles (P < 0.02) and increased postprandial large HDL particles (P < 0.01). Lipoprotein insulin resistance score, glucose and the insulin area under the curve (AUC) decreased significantly after walnut consumption (P < 0.01, P < 0.02 and P < 0.04, respectively). Consuming walnuts significantly increased 10 N-glycans, with eight of them carrying a fucose core. Lipidomic analysis showed a robust reduction in harmful ceramides, hexosylceramides and sphingomyelins, which have been shown to mediate effects on cardiometabolic risk. The peptide YY AUC significantly increased after walnut consumption (P < 0.03). No major significant changes in haemodynamic or metabolomic analysis or in microbiome host health-promoting bacteria such as Faecalibacterium were found.
CONCLUSIONS


These data provide a more comprehensive mechanistic perspective of the effect of dietary walnut consumption on cardiometabolic variables. Lipidomic and lipid nuclear magnetic resonance spectroscopy analysis showed an early but significant reduction in ceramides and other atherogenic lipids with walnut consumption, which may explain the longer-term benefits of walnuts or other nuts on insulin resistance, cardiovascular risk and mortality.",2019,Walnut consumption improved aspects of the lipid profile; it reduced fasting small and dense LDL particles (P < 0.02) and increased postprandial large HDL particles (P < 0.01).,"['participants had two 5-day inpatient stays, during which they consumed a', 'obese people', '10 obese individuals']","['smoothie containing 48\u2009g walnuts or a macronutrient-matched placebo smoothie without nuts', 'placebo', 'walnut consumption', 'dietary walnut consumption']","['insulin resistance, cardiovascular risk and mortality', 'haemodynamic or metabolomic analysis', 'fasting small and dense LDL particles', 'Lipoprotein insulin resistance score, glucose and the insulin area under the curve (AUC', 'cardiometabolic outcomes', 'postprandial large HDL particles']","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0993635', 'cui_str': 'English walnut'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1328813', 'cui_str': 'Metabolomic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}]",10.0,0.483658,Walnut consumption improved aspects of the lipid profile; it reduced fasting small and dense LDL particles (P < 0.02) and increased postprandial large HDL particles (P < 0.01).,"[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Tuccinardi', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Beth Israel Deaconess Medical Centre/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Farr', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Beth Israel Deaconess Medical Centre/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jagriti', 'Initials': 'J', 'LastName': 'Upadhyay', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Beth Israel Deaconess Medical Centre/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Sabrina M', 'Initials': 'SM', 'LastName': 'Oussaada', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Beth Israel Deaconess Medical Centre/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Klapa', 'Affiliation': 'Department of Chemical & Biomolecular Engineering & Bioengineering, Metabolic Engineering and Systems Biology Laboratory, Institute of Chemical Engineering Sciences, Foundation for Research and Technology-Hellas, Patras, Greece.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Candela', 'Affiliation': 'Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rampelli', 'Affiliation': 'Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Lehoux', 'Affiliation': 'Department of Surgery, Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Lázaro', 'Affiliation': 'CIBERde Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Sala-Vila', 'Affiliation': 'CIBERde Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Brigidi', 'Affiliation': 'Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Cummings', 'Affiliation': 'Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Beth Israel Deaconess Medical Centre/Harvard Medical School, Boston, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13773']
1555,10852048,[The evaluation of the reactogenicity and immunogenic activity of a new concentrated inactivated leptospirosis vaccine].,"In the controlled field trial the reactogenicity, safety and antigenic activity of a new concentrated inactivated leptospirosis vaccine after its administration in one and two injections of 0.5 ml were studied in comparison with those of the existing commercial vaccine, introduced in two injections in doses of 2.0 and 2.5 ml. The new experimental vaccine exhibited low reactogenicity and was found to be safe and highly immunogenic when introduced in a single injection of 0.5 ml. As shown in this trial, the immunogenic characteristics of immunization made in a single injection were not inferior than those obtained as the result of immunization made in two injections, yielding high percentage of seroconversions (89.8% to 98.3%) with respect to 4 Leptospira serogroups and leading to the production of the protective titers of corresponding antibodies. The existing commercial vaccine was inferior to the experimental one in antigenic activity (the frequency of seroconversions, antibody titers). The results of the trial make it possible to recommend the experimental concentrated leptospirosis vaccine for use in medical practice in a dose of 0.5 ml introduced in a single injection.",1999,"The existing commercial vaccine was inferior to the experimental one in antigenic activity (the frequency of seroconversions, antibody titers).",[],['new concentrated inactivated leptospirosis vaccine'],"['reactogenicity and immunogenic activity', 'reactogenicity, safety and antigenic activity']",[],"[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0023364', 'cui_str': 'Leptospira Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0335361,"The existing commercial vaccine was inferior to the experimental one in antigenic activity (the frequency of seroconversions, antibody titers).","[{'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Ikoev', 'Affiliation': 'Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations, Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gorbunov', 'Affiliation': ''}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Vachaev', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Iagovkin', 'Affiliation': ''}, {'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Kondratenko', 'Affiliation': ''}, {'ForeName': 'Iu V', 'Initials': 'IuV', 'LastName': ""Anan'ina"", 'Affiliation': ''}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Ansimova', 'Affiliation': ''}, {'ForeName': 'N I', 'Initials': 'NI', 'LastName': 'Kostina', 'Affiliation': ''}, {'ForeName': 'I L', 'Initials': 'IL', 'LastName': ""Iur'eva"", 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Nikitin', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1556,12630351,[Multicomponent vaccine VP-4 in the therapy of allergic diseases].,"In the present study the results of the polycomponent vaccine B[symbol: see text]-4 use for the therapy of patients with bronchial asthma (BA) and latex allergy were generalized. The vaccine was introduced by the nasal-subcutaneous or nasal-oral administration simultaneously with the basic therapy. Te studies were conducted first on limited groups of patients, then in the course of the State Trial with the use of placebo control. Excellent and good effect lasting for 1 year and over was registered in 36 patients (66.7%) out of 54 BA patients receiving the vaccine by the intranasal-subcutaneous method. Immunotherapy produced no positive effect in 13 patients (24.1%). Out of 35 examined patients receiving the vaccine by the intranasal oral method, excellent and good effect was registered in 26 patients (74.2%). No effect was registered in 4 patients (11.4%). In the group of 28 patients receiving placebo simultaneously with the basic therapy positive dynamics in the course of the disease was observed only in 3 patients. Treatment with polycomponent vaccine B[symbol: see text]-4 led to a prolonged (to a year and more) decrease in the frequency and severity of exacerbations, contributed to the prolongation of remissions and to a decrease in the amount of administered medicinal preparations, especially systemic corticosteroids. Immunotherapy ensured the correction of the content of lymphocyte subpopulations with markers CD3, CD4, CD72 and a rise in the titers of antibodies to antigens contained in the preparation. The use of therapeutic polycomponent vaccine B[symbol: see text]-4 for the treatment of patients with latex allergy ensured the state of prolonged remission in this group of patients. On the basis of our investigations we believe that the use of the therapeutic polycomponent vaccine B[symbol: see text]-4 may be included into the basis therapy of allergic diseases.",2003,"Immunotherapy ensured the correction of the content of lymphocyte subpopulations with markers CD3, CD4, CD72 and a rise in the titers of antibodies to antigens contained in the preparation.","['28 patients receiving', '36 patients (66.7%) out of 54 BA patients receiving the', 'allergic diseases', 'patients with latex allergy', 'patients with bronchial asthma (BA) and latex allergy were generalized']","['polycomponent vaccine B[symbol', 'placebo control', 'placebo', 'vaccine', 'therapeutic polycomponent vaccine B[symbol', 'Multicomponent vaccine VP-4', 'Immunotherapy']",['frequency and severity of exacerbations'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0577628', 'cui_str': 'Rubber Allergy'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",54.0,0.0238879,"Immunotherapy ensured the correction of the content of lymphocyte subpopulations with markers CD3, CD4, CD72 and a rise in the titers of antibodies to antigens contained in the preparation.","[{'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Osipova', 'Affiliation': 'Research Institute of Pulmonology, Moscow, Russia.'}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1557,11550573,[Vaccine prophylaxis in elderly patients].,"In 1997-1999 observation was made on elderly people living in old people's homes and in families, as well as groups of young males living in hostel-type homes, altogether 4,518 subjects. Standard inactivated whole-virion influenza vaccine was introduced in a dose of 0.5 ml subcutaneously in a single injection or intranasally in two administrations. In control groups placebo was used. The frequency of seroconversions to vaccine strains of influenza viruses was significantly less in elderly people than in young people following both subcutaneous and intranasal immunization (on the average, by 15-20%). In young people the prophylactic effectiveness of the vaccine introduced intranasally was the same as after subcutaneous immunization with the effectiveness index (EI) being equal to 2.1-2.8. In elderly people the effectiveness of the vaccine after subcutaneous immunization was the same as in young people (EI = 1.7-2.7), but insufficient after intranasal immunization (EI < or = 1.6). The preparation ""Amber elixir plus"" enhanced the effectiveness of immunization against influenza in elderly people.",2001,"The frequency of seroconversions to vaccine strains of influenza viruses was significantly less in elderly people than in young people following both subcutaneous and intranasal immunization (on the average, by 15-20%).","['elderly people', ""elderly people living in old people's homes and in families, as well as groups of young males living in hostel-type homes, altogether 4,518 subjects"", 'elderly patients']","['Standard inactivated whole-virion influenza vaccine', 'placebo']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0578835', 'cui_str': 'Lives in residential hostel (finding)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],4518.0,0.0186675,"The frequency of seroconversions to vaccine strains of influenza viruses was significantly less in elderly people than in young people following both subcutaneous and intranasal immunization (on the average, by 15-20%).","[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Erofeeva', 'Affiliation': 'Research Institute of Influenza, St. Petersburg, Russia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Paramonova', 'Affiliation': ''}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Maksakova', 'Affiliation': ''}, {'ForeName': 'I L', 'Initials': 'IL', 'LastName': 'Kolyvanova', 'Affiliation': ''}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Nikolaeva', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Shadrin', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1558,11236499,[Immunotherapy in the complex treatment of patients with atopic dermatitis with sensitization to house dust mites].,"Ninety-nine patients aged 16-52 years with disseminated atopic dermatitis at the remission were examined and treated. The patients were divided into 3 groups according to the method of therapy. Group 1 (28 patients aged 17-52 years, found to be sensitive to Dermatophagoides pteronyssinus and D. farinae) received, in addition to standard treatment, immunotherapy (oral hyposensitization with mite allergens) in combination with ointment containing retinopalmitate and methyluracil. Group 2 (39 patients aged 17-40 years) received standard treatment combined with the administration of placebo. Group 3 (32 patients aged 16-27 years) received only standard therapy. Groups 2 and 3 were used for comparison. The results of treatment were evaluated according to changes in the immune status of the patients and a complex of clinical characteristics. Essential improvement in clinical characteristics and the normalization of immunological parameters were registered in group 1, which proved that immunotherapy was effective and safe.",2001,"Essential improvement in clinical characteristics and the normalization of immunological parameters were registered in group 1, which proved that immunotherapy was effective and safe.","['Group 1 (28 patients aged 17-52 years, found to be sensitive to Dermatophagoides pteronyssinus and D. farinae', 'Ninety-nine patients aged 16-52 years with disseminated atopic dermatitis at the remission were examined and treated', 'Group 2 (39 patients aged 17-40 years) received', 'Group 3 (32 patients aged 16-27 years) received', 'patients with atopic dermatitis with sensitization to house dust mites']","['standard treatment combined with the administration of placebo', 'immunotherapy (oral hyposensitization with mite allergens) in combination with ointment containing retinopalmitate and methyluracil', 'only standard therapy', 'Immunotherapy']",[],"[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1122992', 'cui_str': 'European House Dust Mite'}, {'cui': 'C0323677', 'cui_str': 'House Dust Mite, American'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0205221', 'cui_str': 'Disseminated (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C3539110', 'cui_str': 'house dust mites'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1320241', 'cui_str': 'Mite allergen'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0128293', 'cui_str': 'methyluracil'}]",[],99.0,0.0160961,"Essential improvement in clinical characteristics and the normalization of immunological parameters were registered in group 1, which proved that immunotherapy was effective and safe.","[{'ForeName': 'S Iu', 'Initials': 'SIu', 'LastName': 'Petrova', 'Affiliation': 'Mechnikov Research Institute for Vaccines and Sera, Moscow, Russia.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Berzhets', 'Affiliation': ''}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': ""Al'banova"", 'Affiliation': ''}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Bystritskaia', 'Affiliation': ''}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Petrova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1559,31462284,Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: protocol for a cluster randomized controlled trial in Georgia.,"BACKGROUND


Tuberculosis is one of the greatest global health concerns and disease management is challenging particularly in low- and middle-income countries. Despite improvements in addressing this epidemic in Georgia, tuberculosis remains a significant public health concern due to sub-optimal patient management. Low remuneration for specialists, limited private-sector interest in provision of infectious disease care and incomplete integration in primary care are at the core of this problem.
METHODS


This protocol sets out the methods of a two-arm cluster randomized control trial which aims to generate evidence on the effectiveness of a performance-based financing and integrated care intervention on tuberculosis loss to follow-up and treatment adherence. The trial will be implemented in health facilities (clusters) under-performing in tuberculosis management. Eligible and consenting facilities will be randomly assigned to either intervention or control (standard care). Health providers within intervention sites will form a case management team and be trained in the delivery of integrated tuberculosis care; performance-related payments based on monthly records of patients adhering to treatment and quality of care assessments will be disbursed to health providers in these facilities. The primary outcomes include loss to follow-up among adult pulmonary drug-sensitive and drug-resistant tuberculosis patients. Secondary outcomes are adherence to treatment among drug-sensitive and drug-resistant tuberculosis patients and treatment success among drug-sensitive tuberculosis patients. Data on socio-demographic characteristics, tuberculosis diagnosis and treatment regimen will also be collected. The required sample size to detect a 6% reduction in loss to follow-up among drug-sensitive tuberculosis patients and a 20% reduction in loss to follow-up among drug-resistant tuberculosis patients is 948 and 136 patients, respectively.
DISCUSSION


The trial contributes to a limited body of rigorous evidence and literature on the effectiveness of supply-side performance-based financing interventions on tuberculosis patient outcomes. Realist and health economic evaluations will be conducted in parallel with the trial, and associated composite findings will serve as a resource for the Georgian and wider regional Ministries of Health in relation to future tuberculosis and wider health policies. The trial and complementing evaluations are part of Results4TB, a multidisciplinary collaboration engaging researchers and Georgian policy and practice stakeholders in the design and evaluation of a context-sensitive tuberculosis management intervention.
TRIAL REGISTRATION


ISRCTN, ISRCTN14667607 . Registered on 14 January 2019.",2019,"Despite improvements in addressing this epidemic in Georgia, tuberculosis remains a significant public health concern due to sub-optimal patient management.","['Eligible and consenting facilities', 'tuberculosis patient outcomes']","['intervention or control (standard care', 'performance-based financing and integrated care intervention', 'supply-side performance-based financing interventions']","['adherence to treatment among drug-sensitive and drug-resistant tuberculosis patients and treatment success', 'loss to follow-up among adult pulmonary drug-sensitive and drug-resistant tuberculosis patients']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0206525', 'cui_str': 'Tuberculosis, Drug-Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}]",,0.0998268,"Despite improvements in addressing this epidemic in Georgia, tuberculosis remains a significant public health concern due to sub-optimal patient management.","[{'ForeName': 'Ivdity', 'Initials': 'I', 'LastName': 'Chikovani', 'Affiliation': 'Curatio International Foundation, 3 Kavsadze Str., 0179, Tbilisi, Georgia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Diaconu', 'Affiliation': 'Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Duric', 'Affiliation': 'Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Lela', 'Initials': 'L', 'LastName': 'Sulaberidze', 'Affiliation': 'Curatio International Foundation, 3 Kavsadze Str., 0179, Tbilisi, Georgia. l.sulaberidze@curatio.com.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Uchaneishvili', 'Affiliation': 'Curatio International Foundation, 3 Kavsadze Str., 0179, Tbilisi, Georgia.'}, {'ForeName': 'Nuredin Ibrahim', 'Initials': 'NI', 'LastName': 'Mohammed', 'Affiliation': 'MRC Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Akaki', 'Initials': 'A', 'LastName': 'Zoidze', 'Affiliation': 'Curatio International Foundation, 3 Kavsadze Str., 0179, Tbilisi, Georgia.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Witter', 'Affiliation': 'Queen Margaret University, Edinburgh, UK.'}]",Trials,['10.1186/s13063-019-3621-z']
1560,31822377,Feasibility of a self-management intervention in adolescents with headache (SMI-AH).,"PURPOSE


This study assessed the acceptability and limited efficacy of a self-management intervention to improve lifestyle behaviors and headache outcomes among rural adolescents with recurrent headache.
DESIGN AND METHODS


Participants were randomly assigned to a self-management intervention for adolescent headache (SMI-AH, n = 13) or standard care group (n = 17). The SMI-AH group participated in goal-setting, self-monitoring, and information processing to modify lifestyle behaviors (missed meals, caffeine intake, and poor sleep). Independent samples t-test was used to compare the means of outcomes at baseline and 6-week follow-up between the treatment group and control group. Linear mixed model (LMM) was used to examine the intervention effects over time.
RESULTS


The mean age was 14.8 years (sd = 1.6, range, 12-17); with female participants accounting for 80% of the sample (n = 24) and persons reporting white race were 97% (n = 29). The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch. The multivariate LMM showed significant intervention effect of lunch intake (p = 0.042 with Cohen's d = 0.42) and borderline significant effect of breakfast intake (p = 0.064 with Cohen's d = 0.38). Participants reported the intervention was easy to use and helpful to monitor behaviors.
CONCLUSIONS


Among rural adolescents, a self-management intervention is a feasible approach for engaging youth. The SMI-AH provides an opportunity for the adolescents to talk about their behaviors and participate in goal setting as well as the plan of care with the provider. Challenges identified in this study are manageable and a full study is feasible with modifications.",2020,"The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch.","['adolescents with headache (SMI-AH', 'Participants', 'rural adolescents with recurrent headache', 'The mean age was 14.8\xa0years (sd\xa0=\xa01.6, range, 12-17); with female participants accounting for 80% of the sample (n\xa0=\xa024) and persons reporting white race were 97% ', 'rural adolescents']","['self-management intervention for adolescent headache (SMI-AH, n\xa0=\xa013) or standard care group', 'self-management intervention']","['lifestyle behaviors and headache outcomes', 'lunch intake', 'days of eating breakfast and lunch', 'lifestyle behaviors', 'breakfast intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0239888', 'cui_str': 'Headache recurrent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]",,0.0316817,"The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch.","[{'ForeName': 'Suzy Mascaro', 'Initials': 'SM', 'LastName': 'Walter', 'Affiliation': 'Department of Family and Community Health, West Virginia University School of Nursing, Morgantown, WV 26506, United States of America. Electronic address: swalters@hsc.wvu.edu.'}, {'ForeName': 'R David', 'Initials': 'RD', 'LastName': 'Parker', 'Affiliation': 'Adelphi University College of Nursing and Public Health, Garden City, NY 11530, United States of America. Electronic address: rdparker@adelphi.edu.'}, {'ForeName': 'Kesheng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Family and Community Health, West Virginia University School of Nursing, Morgantown, WV 26506, United States of America. Electronic address: kesheng.wang@hsc.wvu.edu.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'West Virginia University School of Public Health, Morgantown, WV 26506, United States of America. Electronic address: Zheng.Dai@hsc.wvu.edu.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Starcher', 'Affiliation': 'West Virginia University School of Public Health, Morgantown, WV 26506, United States of America. Electronic address: mrstarcher@hsc.wvu.edu.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151223']
1561,31740726,"Neuromodulation of the prefrontal cortex facilitates diet-induced weight loss in midlife women: a randomized, proof-of-concept clinical trial.","BACKGROUND


High body mass index (BMI) is associated with neurocognitive impairments that contribute to overeating and interfere with weight loss efforts. Overweight and obesity at midlife can accelerate neurodegenerative changes and increase the risk of late-life dementia. Noninvasive neuromodulation represents a novel, affordable and scalable approach to improve neurocognitive function in this context. The purpose of this proof-of-concept study was to examine whether transcranial direct current stimulation (tDCS) aimed at enhancing prefrontal cortex activity could enhance weight loss, in combination with a hypocaloric diet, and study underlying mechanisms.
METHODS


Overall, 38 women with BMI 25-35 kg/m 2  underwent a 4 week randomized, double-blinded, sham-controlled, and parallel-design intervention, during which they received eight sessions of tDCS (n = 18 sham, n = 20 active) in combination with a diet (caloric goal of 20 kcal/kg/day). We evaluated longitudinal changes in body weight, appetite and food craving. In addition, we examined the contribution of cognitive-executive processes via food-modified computerized tasks.
RESULTS


We found that the active group had more reduction in body weight than the sham group throughout the study (p = 0.020) and significant weekly weight loss. At 4 weeks, the active group lost 2.32% of initial body weight (sham: 1.29%). Components of subjective appetite and food craving showed a trend toward more reduction in the active group. These changes were paralleled by significant improvements in task performance in the active group, particularly in a dual task that required inhibitory control and working memory (p = 0.007-0.031). Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003). No significant adverse effects were observed.
CONCLUSIONS


Our results provide proof-of-concept validation of prefrontal-targeted tDCS, combined with a diet, in midlife women with excess body weight, paving the way for larger studies evaluating clinical efficacy and long-term effects of this intervention.",2020,"Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003).","['38 women with BMI 25-35\u2009kg/m 2', 'midlife women with excess body weight', 'midlife women']","['transcranial direct current stimulation (tDCS', 'tDCS (n\u2009=\u200918 sham, n\u2009=\u200920 active) in combination with a diet']","['neurocognitive function', 'body weight', 'body weight, appetite and food craving', 'weight loss', 'task performance', 'inhibitory control and working memory', 'subjective appetite and food craving', 'adverse effects', 'lack of control overeating']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]",38.0,0.115754,"Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Amo Usanos', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Villa', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Santiago Milla', 'Initials': 'SM', 'LastName': 'Navarro', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Andresa Evelem de', 'Initials': 'AE', 'LastName': 'Melo Aroeira', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Amo Usanos', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Martínez Cancio', 'Affiliation': 'Primary Care Unit, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cuesta Villa', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Section on Genetics and Epidemiology, Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. migalonsoalonso@alumni.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0486-x']
1562,32060497,"Glycolysis/gluconeogenesis- and tricarboxylic acid cycle-related metabolites, Mediterranean diet, and type 2 diabetes.","BACKGROUND


Glycolysis/gluconeogenesis and tricarboxylic acid (TCA) cycle metabolites have been associated with type 2 diabetes (T2D). However, the associations of these metabolites with T2D incidence and the potential effect of dietary interventions remain unclear.
OBJECTIVES


We aimed to evaluate the association of baseline and 1-y changes in glycolysis/gluconeogenesis and TCA cycle metabolites with insulin resistance and T2D incidence, and the potential modifying effect of Mediterranean diet (MedDiet) interventions.
METHODS


We included 251 incident T2D cases and 638 noncases in a nested case-cohort study within the PREDIMED Study during median follow-up of 3.8 y. Participants were allocated to MedDiet + extra-virgin olive oil, MedDiet + nuts, or control diet. Plasma metabolites were measured using a targeted approach by LC-tandem MS. We tested the associations of baseline and 1-y changes in glycolysis/gluconeogenesis and TCA cycle metabolites with subsequent T2D risk using weighted Cox regression models and adjusting for potential confounders. We designed a weighted score combining all these metabolites and applying the leave-one-out cross-validation approach.
RESULTS


Baseline circulating concentrations of hexose monophosphate, pyruvate, lactate, alanine, glycerol-3 phosphate, and isocitrate were significantly associated with higher T2D risk (17-44% higher risk for each 1-SD increment). The weighted score including all metabolites was associated with a 30% (95% CI: 1.12, 1.51) higher relative risk of T2D for each 1-SD increment. Baseline lactate and alanine were associated with baseline and 1-y changes of homeostasis model assessment of insulin resistance. One-year increases in most metabolites and in the weighted score were associated with higher relative risk of T2D after 1 y of follow-up. Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons.
CONCLUSIONS


We identified a panel of glycolysis/gluconeogenesis-related metabolites that was significantly associated with T2D risk in a Mediterranean population at high cardiovascular disease risk. A MedDiet could counteract the detrimental effects of these metabolites.This trial was registered at controlled-trials.com as ISRCTN35739639.",2020,"Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons.
","['251 incident T2D cases and 638 noncases in a nested case-cohort study within the PREDIMED Study during median follow-up of 3.8 y. Participants', 'Mediterranean population at high cardiovascular disease risk']","['MedDiet\xa0+\xa0extra-virgin olive oil, MedDiet\xa0+\xa0nuts, or control diet', 'gluconeogenesis and tricarboxylic acid ', 'Glycolysis/gluconeogenesis- and tricarboxylic acid cycle-related metabolites, Mediterranean diet', 'Mediterranean diet (MedDiet) interventions']","['Plasma metabolites', 'Lower risks', 'hexose monophosphate, pyruvate, lactate, alanine, glycerol-3 phosphate, and isocitrate', 'T2D risk', 'Baseline lactate and alanine', 'weighted score including all metabolites']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0017715', 'cui_str': 'Gluconeogenesis'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}, {'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019494', 'cui_str': 'Hexose'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0051369', 'cui_str': 'alpha-glycerophosphoric acid'}, {'cui': 'C0022160', 'cui_str': 'Isocitrates'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",251.0,0.0569746,"Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Guasch-Ferré', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Santos', 'Affiliation': 'Department of Nutrition, Diabetes and Metabolism, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Clary B', 'Initials': 'CB', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Razquin', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Dennis', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Muñoz-Bravo', 'Affiliation': 'Department of Public Health and Psychiatry, University of Málaga, Málaga, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Alonso-Gómez', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Canudas', 'Affiliation': 'Human Nutrition Unit, Faculty of Medicine and Health Sciences, Pere Virgili Health Research Institute, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Asensio', 'Affiliation': 'Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Pierce', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Human Nutrition Unit, Faculty of Medicine and Health Sciences, Pere Virgili Health Research Institute, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa016']
1563,31464532,Pulmonary Vascular Pressure Response to Acute Cold Exposure in Kyrgyz Highlanders.,"Background/Aims:  Long-term high altitude residence leads to a sustained increase in pulmonary vascular resistance and elevation of pulmonary artery pressure due to chronic alveolar hypoxia. However, living at high altitude is also associated with other environmental factors such as cold. There is still little experimental evidence suggesting detrimental effects of low temperatures on the pulmonary vasculature. Therefore, our objective was to investigate acute effects of cold exposure on the pulmonary circulation in Kyrgyz high altitude natives.  Methods:  Responses of the pulmonary circulation during acute exposure to controlled cold conditions (4°C-6°C) for 60 minutes were measured in highlanders using Doppler echocardiography. Based on the Doppler echocardiography-derived tricuspid regurgitant systolic pressure gradient (TRG), subjects with TRG ≥40 mmHg were allocated into the pulmonary hypertension (PH) group. Participants from the PH group were compared with volunteer control subjects with TRG <40 mmHg. All baseline measurements were evaluated in a warm room during 60 minutes (22°C-28°C). Following baseline echocardiography, the subjects were assigned to either warm or cold exposure for an additional 60 minutes.  Results:  Acute cold exposure significantly increased TRG both in the control (ΔTRG, 4.93 mmHg) and in the PH (ΔTRG, 8.15 mmHg) group, compared to the respective warm exposure conditions (ΔTRG, -0.14 and -0.05 mmHg). No changes in cardiac output were observed upon cold exposure.  Conclusion:  Thus, acute exposure to cold leads to elevation of pulmonary artery pressure in high altitude residents.",2019,"Results:  Acute cold exposure significantly increased TRG both in the control (ΔTRG, 4.93 mmHg) and in the PH (ΔTRG, 8.15 mmHg) group, compared to the respective warm exposure conditions (ΔTRG, -0.14 and -0.05 mmHg).","['Kyrgyz Highlanders', 'kyrgyz highlanders', 'subjects with TRG ≥40\u2009mmHg were allocated into the pulmonary hypertension (PH) group', 'Kyrgyz high altitude natives']","['High Alt Med Biol', 'Doppler echocardiography-derived tricuspid regurgitant systolic pressure gradient (TRG']","['Sydykov, Akylbek, Abdirashit Maripov, Kubatbek Muratali Uulu, Nadira Kushubakova, Aleksandar Petrovic, Christina Vroom, Meerim Cholponbaeva, Melis Duishobaev, Samatbek Satybaldyev, Nurgul Satieva, Argen Mamazhakypov, Meerim Sartmyrzaeva, Nazgul Omurzakova, Zhainagul Kerimbekova, Nursultan Baktybek, Oleg Pak, Lan Zhao, Norbert Weissmann, Akpay Sarybaev, Sergey Avdeev, Hossein Ardeschir Ghofrani, Ralph Theo Schermuly, and Djuro Kosanovic', 'Pulmonary vascular pressure response', 'cardiac output', 'pulmonary vascular resistance and elevation of pulmonary artery pressure', 'TRG']","[{'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013520', 'cui_str': 'Echocardiography, Doppler'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]","[{'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}]",,0.0376725,"Results:  Acute cold exposure significantly increased TRG both in the control (ΔTRG, 4.93 mmHg) and in the PH (ΔTRG, 8.15 mmHg) group, compared to the respective warm exposure conditions (ΔTRG, -0.14 and -0.05 mmHg).","[{'ForeName': 'Akylbek', 'Initials': 'A', 'LastName': 'Sydykov', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Abdirashit', 'Initials': 'A', 'LastName': 'Maripov', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Kubatbek', 'Initials': 'K', 'LastName': 'Muratali Uulu', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Kushubakova', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Petrovic', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vroom', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Meerim', 'Initials': 'M', 'LastName': 'Cholponbaeva', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Melis', 'Initials': 'M', 'LastName': 'Duishobaev', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Samatbek', 'Initials': 'S', 'LastName': 'Satybaldyev', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nurgul', 'Initials': 'N', 'LastName': 'Satieva', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Argen', 'Initials': 'A', 'LastName': 'Mamazhakypov', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Meerim', 'Initials': 'M', 'LastName': 'Sartmyrzaeva', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nazgul', 'Initials': 'N', 'LastName': 'Omurzakova', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Zhainagul', 'Initials': 'Z', 'LastName': 'Kerimbekova', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nursultan', 'Initials': 'N', 'LastName': 'Baktybek', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Pak', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Weissmann', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Akpay', 'Initials': 'A', 'LastName': 'Sarybaev', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Avdeev', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Hossein Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Ralph Theo', 'Initials': 'RT', 'LastName': 'Schermuly', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Djuro', 'Initials': 'D', 'LastName': 'Kosanovic', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}]",High altitude medicine & biology,['10.1089/ham.2019.0046']
1564,31443716,"A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections.","BACKGROUND


Over many years, OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children. However, further studies are needed to explore the true importance of OM-85 in the prevention of respiratory tract infections (RTIs) in children. This study was planned to further contribute to the evaluation of the role played by OM-85 in prevention of recurrent RTIs in children.
METHODS


This study was a randomized (3:3:1), placebo-controlled, double-blind, single-centre, phase IV trial carried out in Italy to assess the efficacy of OM-85 (Broncho-Vaxom ® ; Vifor Pharma; Meyrin 2/Geneva, Switzerland) in reducing the number of new RTI episodes in 288 children aged 1 to 6 years with a history of recurrent RTIs and to compare the efficacy of the standard 3-month regimen with that of administration of OM-85 for 6 months during a 6-month study period.
RESULTS


The number of RTIs and of children who experienced at least one RTI were significantly lower among patients receiving OM-85 for 3 months than among those given placebo (33% vs 65.1%, p < 0.0001). Differences were statistically significant for upper RTIs (i.e., common cold/viral pharyngitis and acute otitis media; p < 0.0001 and p = 0.006, respectively). Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively). No difference was seen between children who received OM-85 for 3 and those who received OM-85 for 6 months. The prevalence of atopy as well as the history of recurrent wheezing and age of the study child did not influence the results. Benefit was maximally evident among children with a history of frequent recurrences. OM-85 was well tolerated and safe, even in children who received an influenza vaccination.
CONCLUSIONS


The use of OM-85 for 3 months in 3 series of 10 consecutive days each time reduces the risk of recurrent RTIs in children, with a favourable safety profile. The greater effect observed in children prone to several respiratory episodes than in non-prone children seems to indicate that this lysate should be administered especially to children with a proven high susceptibility to RTIs.",2019,"Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively).","['children suffering from recurrent respiratory tract infections', '288 children aged 1 to 6\xa0years with a history of recurrent RTIs', 'children']","['placebo', 'OM-85', 'OM-85 (Broncho-Vaxom ® ']","['tolerated and safe', 'number of RTIs', 'efficacy and safety', 'risk of recurrent RTIs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0863094', 'cui_str': 'Recurrent respiratory tract infections'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0054145', 'cui_str': 'Broncho-Vaxom'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",288.0,0.104231,"Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively).","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy. susanna.esposito@unimi.it.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bianchini', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bosis', 'Affiliation': ""Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Tagliabue', 'Affiliation': ""Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Coro', 'Affiliation': ""Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Argentiero', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Principi', 'Affiliation': 'Università degli Studi di Milano, Milan, Italy.'}]",Journal of translational medicine,['10.1186/s12967-019-2040-y']
1565,32048203,Effects of intravenous and mask induction on post-operative emergence delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy.,"BACKGROUND


Emergence delirium occurs in children during recovery from general anesthesia. The aim of the study was to examine the effects of mask and intravenous sevoflurane anesthesia induction on emergence delirium in children undergoing tonsillectomy with or without adenoidectomy.
METHODS


This single-blinded, prospective, randomized clinical trial was conducted in the operating room and the post-operative recovery area at a university hospital. Sixty-seven children (aged 3-12 years) were randomly assigned to receive either mask induction (group M) or intravenous induction (group IV). Vascular access was provided in group M after 8% sevoflurane and 60% nitrous oxide in oxygen were given through a mask. In the IV cohort, an intravenous cannula was inserted prior to induction. The incidence of emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale after arrival in the post-anesthesia care unit. Post-operative pain was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale.
RESULTS


PAED scores were significantly higher in group M at 5 min (group M = 12.2 ± 4.215, group IV = 9.1 ± 4.0; mean difference = 3.094, 95% CI [1.108; 5.081]; P = 0.003), at 15 min (group M = 8.0 ± 2.6, group IV = 5.1 ± 2.3; mean difference = 2.942, 95% CI [1.586-4.301]; P < 0.001), and at 30 min (group M = 5.1 ± 2.8, group IV = 2.5 ± 1.8; mean difference = 2.620, 95% CI [1.457; 3.783]; P < 0.001) than in group IV. The FLACC scale scores were similar between the two groups.
CONCLUSION


Mask induction for pediatric patients undergoing tonsillectomy with or without adenoidectomy increased Pediatric Anesthesia Emergence Delirium scores more than intravenous induction.
TRIAL REGISTRATION


NCT03252405.",2020,"RESULTS


PAED scores were significantly higher in group M at 5 min (group M = 12.2 ± 4.215, group IV = 9.1 ± 4.0; mean difference = 3.094, 95% CI [1.108; 5.081]; P = 0.003), at 15 min (group M = 8.0 ± 2.6, group IV = 5.1 ± 2.3; mean difference = 2.942, 95% CI [1.586-4.301]; P < 0.001), and at 30 min (group M = 5.1 ± 2.8, group IV = 2.5 ± 1.8; mean difference = 2.620, 95% CI [1.457; 3.783]; P < 0.001) than in group IV.","['children during recovery from general anesthesia', 'pediatric patients undergoing tonsillectomy with or without adenoidectomy', 'children undergoing tonsillectomy with or without adenoidectomy', 'pediatric patients undergoing', 'Sixty-seven children (aged 3-12\xa0years']","['sevoflurane anesthesia induction', 'intravenous and mask induction', 'tonsillectomy with or without adenoidectomy', 'sevoflurane and 60% nitrous oxide', 'mask induction (group M) or intravenous induction']","['Pediatric Anesthesia Emergence Delirium scores', 'PAED scores', 'Vascular access', 'Face, Legs, Activity, Cry, and Consolability (FLACC) scale', 'Pediatric Anesthesia Emergence Delirium (PAED) scale', 'FLACC scale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction (procedure)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}]",67.0,0.219269,"RESULTS


PAED scores were significantly higher in group M at 5 min (group M = 12.2 ± 4.215, group IV = 9.1 ± 4.0; mean difference = 3.094, 95% CI [1.108; 5.081]; P = 0.003), at 15 min (group M = 8.0 ± 2.6, group IV = 5.1 ± 2.3; mean difference = 2.942, 95% CI [1.586-4.301]; P < 0.001), and at 30 min (group M = 5.1 ± 2.8, group IV = 2.5 ± 1.8; mean difference = 2.620, 95% CI [1.457; 3.783]; P < 0.001) than in group IV.","[{'ForeName': 'Kevser', 'Initials': 'K', 'LastName': 'Peker', 'Affiliation': 'Department of Anesthesiology and Critical Care, Kırıkkale University School of Medicine, Kırıkkale, Turkey. drbabacan@hotmail.com.'}, {'ForeName': 'Reyhan', 'Initials': 'R', 'LastName': 'Polat', 'Affiliation': 'Department of Anesthesiology and Critical Care, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02197-4']
1566,31515972,Evaluation of paliperidone palmitate long-acting injectable antipsychotic therapy as an early treatment option in patients with schizophrenia.,"AIM


This exploratory post hoc analysis of a randomized, double-blind (DB), multicentre, non-inferiority study (NCT01515423) evaluated the effects of the long-acting injectable antipsychotic therapies once-monthly paliperidone palmitate (PP1M) and once-every-3-months paliperidone palmitate (PP3M) on symptom severity and functional remission in patients with schizophrenia with differing durations of illness (≤5, 6-10 and >10 years).
METHODS


Endpoints included Personal and Social Performance (PSP) scale and Positive and Negative Syndrome Scale (PANSS) total scores during the DB phase (DB baseline and DB endpoint) and the proportion of patients meeting PSP or PANSS remission criteria at any time during the open-label (OL) or DB phases that were maintained for ≥3, ≥6, ≥9 or ≥12 months.
RESULTS


In both the OL and DB phases, significant improvements in PSP scale and PANSS scores were observed from baseline in all duration-of-illness groups, with significantly greater improvements observed in the ≤5-year and 6-10-year groups compared with the >10-year group. The proportion of patients who maintained PSP or PANSS remission criteria for ≥3, ≥6, ≥9 and ≥12 months was higher in the ≤5-year and 6-10-year groups than in the >10-year group. Safety profiles were similar across duration-of-illness groups in the DB phase.
CONCLUSIONS


Symptomatic and functional improvements were observed with PP1M/PP3M in patients with differing durations of schizophrenia, but the magnitude of the effects was greater in those with early illness vs chronic illness. These findings advocate implementation of PP1M and PP3M in all stages of schizophrenia, including early illness.",2020,"In both the OL and DB phases, significant improvements in PSP scale and PANSS scores were observed from baseline in all duration-of-illness groups, with significantly greater improvements observed in the ≤5-year and 6-10-year groups compared with the >10-year group.","['patients with schizophrenia with differing durations of illness (≤5, 6-10 and >10\u2009years', 'patients with schizophrenia']","['paliperidone palmitate long-acting injectable antipsychotic therapy', 'paliperidone palmitate (PP1M) and once-every-3-months paliperidone palmitate (PP3M']","['PSP scale and PANSS scores', 'symptom severity and functional remission', 'Personal and Social Performance (PSP) scale and Positive and Negative Syndrome Scale (PANSS) total scores during the DB phase (DB baseline and DB endpoint) and the proportion of patients meeting PSP or PANSS remission criteria at any time during the open-label (OL) or DB phases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2719626', 'cui_str': 'paliperidone palmitate'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0222045'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",,0.0677623,"In both the OL and DB phases, significant improvements in PSP scale and PANSS scores were observed from baseline in all duration-of-illness groups, with significantly greater improvements observed in the ≤5-year and 6-10-year groups compared with the >10-year group.","[{'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, New Jersey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Turkoz', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, New Jersey.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Mancevski', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, New Jersey.'}, {'ForeName': 'Maju', 'Initials': 'M', 'LastName': 'Mathews', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, New Jersey.'}]",Early intervention in psychiatry,['10.1111/eip.12868']
1567,12449696,[Influence of multiplicity of immunizations of children with inactivated influenza vaccine on immune response and the effectiveness of protection].,"The formation of immunity and epidemiological effectiveness of inactivated influenza vaccines in children, regularly immunized against influenza for three years, were evaluated. The study revealed that a year after each immunization the number of children having antibodies in liters regarded as protective decreased 2-2.5 times. At the periods of epidemics morbidity rate among the vaccines dynamically decreased in these years 1.3, 2.0 and 2.8 times. Considering that a year after the second immunization a high immune stratum (60-78%) was retained in the group under study, we propose that annual immunization of the same children be limited by a period of three years, followed by an interval of one year.",2002,"At the periods of epidemics morbidity rate among the vaccines dynamically decreased in these years 1.3, 2.0 and 2.8 times.","['children, regularly immunized against influenza for three years', 'children with inactivated']","['inactivated influenza vaccines', 'influenza vaccine']","['epidemics morbidity rate', 'immune response', 'formation of immunity and epidemiological effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0223931,"At the periods of epidemics morbidity rate among the vaccines dynamically decreased in these years 1.3, 2.0 and 2.8 times.","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Slobodniuk', 'Affiliation': 'Urals State Medical Academy, Regional Center of Sanitary and Epidemiological Surveillance, Yekaterinburg, Russia.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Romanenko', 'Affiliation': ''}, {'ForeName': 'O S', 'Initials': 'OS', 'LastName': 'Utnitskaia', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Motus', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Pereverzev', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1568,10876866,[The intestinal microbiocenosis of children with diarrheal diseases during lactoglobulin treatment].,,1999,,['children with diarrheal diseases during lactoglobulin treatment'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0022945', 'cui_str': 'Lactoglobulins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],[],,0.0144979,,"[{'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Aleksanina', 'Affiliation': 'Research Institute of Microbiology and Parasitology, State Medical University, Rostov-on-Don, Russia.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Soboleva', 'Affiliation': ''}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': ""Simovan'ian"", 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Loverdo', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1569,32441031,Electrocautery Needling and the 308-nm Excimer Lamp: A Synergistic Combination for the Treatment of Stable Non-segmental Vitiligo.,"INTRODUCTION


Vitiligo is an acquired chronic depigmentation disorder caused by the destruction of melanocytes. Although various treatments have been proposed for the management of vitiligo, achieving repigmentation and preventing relapse remains challenging. The aim of the study was to evaluate the effectiveness of electrocautery needling (EC needling) as a treatment for stable non-segmental vitiligo and to determine if the effectiveness of this treatment could be enhanced by combining it with the 308-nm excimer lamp (excimer lamp).
METHODS


Thirty patients with stable non-segmental vitiligo were enrolled in this self-controlled, non-blinded study. Three vitiligo lesions of similar size, location and disease duration were selected from each patient and randomly assigned to one of three groups treated weekly with EC needling, an excimer lamp or a combination of both (combination group), respectively. The effectiveness of treatment on the repigmentation percentage and the number of treatments required for initial pigmentation were assessed.
RESULTS


There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789). The mean number of treatments required for initial repigmentation was lower in the EC needling group than in the excimer lamp group (P = 0.049). The repigmentation percentage was significantly higher in the combination group than in the EC needling group (P = 0.027) and excimer lamp group (P = 0.005). Evidence of initial pigmentation was obtained earlier in lesions treated with the combination therapy than in lesions treated with excimer lamp therapy alone (P = 0.019). Vitiligo lesions on the face and neck regions showed the highest repigmentation percentage among all anatomical regions, whereas lesions on the hands and feet showed the worst treatment response.
CONCLUSION


Electrocautery needling monotherapy was effective in treating vitiligo, and its efficacy was enhanced when combined with the 308-nm excimer lamp. This combined approach to treat vitiligo is safe and helps increase patient compliance.",2020,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"['Thirty patients with stable non-segmental vitiligo', 'Stable Non-segmental Vitiligo', 'stable non-segmental vitiligo']","['excimer lamp therapy', 'Electrocautery needling monotherapy', 'Electrocautery Needling and the 308-nm Excimer Lamp', 'excimer lamp', '308-nm excimer lamp (excimer lamp', 'electrocautery needling (EC needling', 'EC needling, an excimer lamp or a combination of both (combination group']","['repigmentation percentage', 'Vitiligo lesions', 'mean number of treatments required for initial repigmentation', 'initial pigmentation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332121', 'cui_str': 'Treatment required for'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",30.0,0.0265379,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Pui Mun', 'Initials': 'PM', 'LastName': 'Wong', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Katayama', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of TCM Chemistry, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China. zhanghm@shutcm.edu.cn.'}]",Dermatology and therapy,['10.1007/s13555-020-00395-7']
1570,31907828,Evidence for Relationship Between Early Dumping and Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass.,"BACKGROUND


Early dumping and post-bariatric hypoglycemia (PBH) are often addressed as two separate postprandial complications after Roux-en-Y gastric bypass (RYGB). The aim of the study was to evaluate the occurrence of early dumping in RYGB-operated individuals with PBH with and without treatment intervention.
METHODS


Eleven RYGB-operated women with documented PBH each underwent a baseline liquid mixed meal test (MMT) followed by five MMTs preceded by treatment with: acarbose 50 mg for 1 week, sitagliptin 100 mg for 1 week, verapamil 120 mg for 1 week, liraglutide 1.2 mg for 3 weeks, and pasireotide 300 μg as a single dose. Repetitive venous blood sampling and continuous electrocardiogram recordings were performed at fasting and during a 3-h postprandial period.
RESULTS


During the baseline MMT, there was a significant increase in HR (from 65 ± 2 to 90 ± 4 bpm, p < 0.0001) within 30 min after meal intake, while hypoglycemia occurred in the later postprandial period. The HR increase was accompanied by significant increases in serum albumin, plasma norepinephrine, blood glucose, serum insulin, and plasma GLP-1 concentrations. The postprandial HR changes were positively correlated with the changes in insulin and GLP-1 concentrations. Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1.
CONCLUSIONS


RYGB-operated individuals with PBH also have large early postprandial HR increases, hemoconcentration, and sympathetic activation, consistent with early dumping. Moreover, hormone excursions associated with PBH appear to be related to measures of early dumping, suggesting a causal relationship between early dumping and PBH.
TRIAL REGISTRATION


NCT02527993.",2020,"Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1.
","['RYGB-operated individuals with PBH with and without treatment intervention', 'Eleven RYGB-operated women with documented PBH each underwent a']","['acarbose 50\xa0mg for 1\xa0week, sitagliptin 100\xa0mg for 1\xa0week, verapamil', 'liraglutide', 'acarbose and pasireotide', 'baseline liquid mixed meal test (MMT']","['postprandial HR changes', 'Repetitive venous blood sampling and continuous electrocardiogram recordings', 'hemoconcentration, and sympathetic activation', 'insulin and GLP-1 concentrations', 'Postprandial Hypoglycemia', 'hypoglycemia', 'HR', 'HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1', 'serum albumin, plasma norepinephrine, blood glucose, serum insulin, and plasma GLP-1 concentrations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0982924', 'cui_str': 'Acarbose 50 MG'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0199562', 'cui_str': 'Continuous electrocardiogram (procedure)'}, {'cui': 'C0854379', 'cui_str': 'Haemoconcentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0271710', 'cui_str': 'Postprandial Hypoglycemia'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",11.0,0.0160128,"Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1.
","[{'ForeName': 'Caroline C', 'Initials': 'CC', 'LastName': 'Øhrstrøm', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark. carolinechristfort@hotmail.com.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Worm', 'Affiliation': 'Department of Medicine, Amager Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Urd Lynge', 'Initials': 'UL', 'LastName': 'Kielgast', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dorte L', 'Initials': 'DL', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",Obesity surgery,['10.1007/s11695-020-04387-6']
1571,30220261,The pattern of symptom change during prolonged exposure therapy and present-centered therapy for PTSD in active duty military personnel.,"BACKGROUND


Few studies have investigated the patterns of posttraumatic stress disorder (PTSD) symptom change in prolonged exposure (PE) therapy. In this study, we aimed to understand the patterns of PTSD symptom change in both PE and present-centered therapy (PCT).
METHODS


Participants were active duty military personnel (N = 326, 89.3% male, 61.2% white, 32.5 years old) randomized to spaced-PE (S-PE; 10 sessions over 8 weeks), PCT (10 sessions over 8 weeks), or massed-PE (M-PE; 10 sessions over 2 weeks). Using latent profile analysis, we determined the optimal number of PTSD symptom change classes over time and analyzed whether baseline and follow-up variables were associated with class membership.
RESULTS


Five classes, namely rapid responder (7-17%), steep linear responder (14-22%), gradual responder (30-34%), non-responder (27-33%), and symptom exacerbation (7-13%) classes, characterized each treatment. No baseline clinical characteristics predicted class membership for S-PE and M-PE; in PCT, more negative baseline trauma cognitions predicted membership in the non-responder v. gradual responder class. Class membership was robustly associated with PTSD, trauma cognitions, and depression up to 6 months after treatment for both S-PE and M-PE but not for PCT.
CONCLUSIONS


Distinct profiles of treatment response emerged that were similar across interventions. By and large, no baseline variables predicted responder class. Responder status was a strong predictor of future symptom severity for PE, whereas response to PCT was not as strongly associated with future symptoms.",2019,"Class membership was robustly associated with PTSD, trauma cognitions, and depression up to 6 months after treatment for both S-PE and M-PE but not for PCT.
","['Participants were active duty military personnel (N = 326, 89.3% male, 61.2% white, 32.5 years old) randomized to']","['PCT', 'spaced-PE', 'PE and present-centered therapy (PCT']","['gradual responder', 'symptom exacerbation', 'PTSD, trauma cognitions, and depression']","[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0639714,"Class membership was robustly associated with PTSD, trauma cognitions, and depression up to 6 months after treatment for both S-PE and M-PE but not for PCT.
","[{'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street Suite 600 N, Philadelphia, PA 19104,USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Clapp', 'Affiliation': 'University of Wyoming, Laramie, WY, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Kemp', 'Affiliation': 'Warren Alpert Medical School, Providence, RI, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Fort Hood, Texas,USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX,USA.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'VA Boston Healthcare System and Boston University School of Medicine, Boston, MA,USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX,USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX,USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX,USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio and South Texas Veterans Health Care System, San Antonio, TX,USA.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA,USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychological medicine,['10.1017/S0033291718002714']
1572,10808574,"[The evaluation of the reactogenicity, harmlessness and prophylactic efficacy of Grippol trivalent polymer-subunit influenza vaccine administered to schoolchildren].","Vaccine ""Grippol""--has been developed at the State Research Center--Institute of Immunology. The preparation belongs to new generation vaccines and is a trivalent polymer-subunit vaccine containing the sterile conjugate of influenza virus surface proteins, types A and B, bound with copolymer polyoxidonium. The administration of ""Grippol"" to children of school age (6-18 years) demonstrated low reactogenicity of the vaccine, its safety and sufficient prophylactic effectiveness. During observations on total morbidity (with the exception of influenza and acute respiratory diseases) no side effects produced by ""Grippol"" were registered. At the same time the fact that the morbidity rate of upper respiratory tract disease in the group of children immunized with the vaccine decreased in comparison with the control group (by 2.4 times) cannot be disregarded.",2000,"The administration of ""Grippol"" to children of school age (6-18 years) demonstrated low reactogenicity of the vaccine, its safety and sufficient prophylactic effectiveness.",['schoolchildren'],"['Grippol', 'Grippol trivalent polymer-subunit influenza vaccine']","['total morbidity', 'reactogenicity, harmlessness and prophylactic efficacy', 'morbidity rate of upper respiratory tract disease']",[],"[{'cui': 'C0914368', 'cui_str': 'Grippol'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0208569,"The administration of ""Grippol"" to children of school age (6-18 years) demonstrated low reactogenicity of the vaccine, its safety and sufficient prophylactic effectiveness.","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': ""El'shina"", 'Affiliation': 'Tarasevich Research Institute of Standardization and Control of Medical Biological Preparations, State Research Center--Institute of Immunology, Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gorbunov', 'Affiliation': ''}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Bektimirov', 'Affiliation': ''}, {'ForeName': 'N I', 'Initials': 'NI', 'LastName': 'Lonskaia', 'Affiliation': ''}, {'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Pavlova', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': ""Nikul'shin"", 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Khaitov', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Nekrasov', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Ivanova', 'Affiliation': ''}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Matrosovich', 'Affiliation': ''}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Puchkova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1573,31148204,Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial.,"Thromboelastography (TEG) provides a more comprehensive global coagulation assessment than routine tests (international normalized ratio [INR] and platelet [PLT] count), and its use may avoid unnecessary blood component transfusion in patients with advanced cirrhosis and significant coagulopathy who have nonvariceal upper gastrointestinal (GI) bleeding. A total of 96 patients with significant coagulopathy (defined in this study as INR >1.8 and/or PLT count < 50 × 10 9  /L) and nonvariceal upper GI bleed (diagnosed after doing upper gastrointestinal endoscopy, which showed ongoing bleed from a nonvariceal source) were randomly allocated to TEG-guided transfusion strategy (TEG group; n = 49) or standard-of-care (SOC) group (n = 47). In the TEG group, only 26.5% patients were transfused with all three blood components (fresh frozen plasma [FFP], PLTs, and cryoprecipitate) versus 87.2% in the SOC group (P < 0.001). Although 7 (14.3%) patients in the TEG group received no blood component transfusion, there were no such patients in the SOC group (P = 0.012). Also, there was a significantly lower use of blood components (FFP, PLTs, and cryoprecipitate) in the TEG group compared with the SOC group. Failure to control bleed, failure to prevent rebleeds, and mortality between the two groups were similar. Conclusion: In patients with advanced cirrhosis with coagulopathy and nonvariceal upper GI bleeding, TEG-guided transfusion strategy leads to a significantly lower use of blood components compared with SOC (transfusion guided by INR and PLT count), without an increase in failure to control bleed, failure to prevent rebleed, and mortality.",2020,"Also, there was a significantly lower use of blood components (FFP, PLTs, and cryoprecipitate) in the TEG group compared to the SOC group.","['Patients With Cirrhosis With Nonvariceal Bleeding', '96 patients with significant coagulopathy (defined in this study as INR >1.8 and/or PLT count <50 × 10 9  /L) and nonvariceal upper GI bleed (diagnosed after doing upper gastrointestinal endoscopy [UGIE], which showed ongoing bleed from a nonvariceal source', 'patients with advanced cirrhosis and significant coagulopathy who have nonvariceal upper gastrointestinal (GI) bleeding', 'patients with advanced cirrhosis with coagulopathy and nonvariceal upper GI bleeding, TEG-guided transfusion strategy']","['TEG-guided transfusion strategy (TEG group; n = 49) or standard-of-care (SOC', 'Thromboelastography (TEG', 'TEG', 'Thromboelastography-Guided Blood Component Use']","['failure to control bleed, failure to prevent rebleed, and mortality', 'blood component transfusion', 'Failure to control bleed, failure to prevent rebleeds, and mortality', 'blood components (FFP, PLTs, and cryoprecipitate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1263666', 'cui_str': 'Advanced cirrhosis'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0450129', 'cui_str': 'Blood component (substance)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085430', 'cui_str': 'Blood Component Transfusion'}, {'cui': 'C0450129', 'cui_str': 'Blood component (substance)'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}]",96.0,0.0330223,"Also, there was a significantly lower use of blood components (FFP, PLTs, and cryoprecipitate) in the TEG group compared to the SOC group.","[{'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Ahmad', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Maiwall', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Bajpai', 'Affiliation': 'Department of Transfusion Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Lalita G', 'Initials': 'LG', 'LastName': 'Mitra', 'Affiliation': 'Department of Critical Care Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Saluja', 'Affiliation': 'Department of Critical Care Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Mohan Agarwal', 'Affiliation': 'Department of Critical Care Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Chhagan', 'Initials': 'C', 'LastName': 'Bihari', 'Affiliation': 'Department of Pathology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Saggere Muralikrishna', 'Initials': 'SM', 'LastName': 'Shasthry', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Clinical Research, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Biostatistics, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv K', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30794']
1574,31309536,Lifestyle changes for treating psoriasis.,"BACKGROUND


Psoriasis is an inflammatory skin disease that presents with itching, red, scaling plaques; its worsening has been associated with obesity, drinking, smoking, lack of sleep, and a sedentary lifestyle. Lifestyle changes may improve psoriasis.
OBJECTIVES


To assess the effects of lifestyle changes for psoriasis, including weight reduction, alcohol abstinence, smoking cessation, dietary modification, exercise, and other lifestyle change interventions.
SEARCH METHODS


We searched the following databases up to July 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched the China National Knowledge Infrastructure, the Airiti Library, and five trials registers up to July 2018. We checked the references of included trials for further relevant trials, and we asked the authors of the included trials if they were aware of any relevant unpublished data.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) of lifestyle changes (either alone or in combination) for treating psoriasis in people diagnosed by a healthcare professional. Treatment had to be given for at least 12 weeks. Eligible comparisons were no lifestyle changes or another active intervention.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. The primary outcome measures were 'Severity of psoriasis' and 'Adherence to the intervention'. Secondary outcomes were 'Quality of life', 'Time to relapse', and 'Reduction in comorbidities'. We used GRADE to assess the quality of the evidence for each outcome.
MAIN RESULTS


We included 10 RCTs with 1163 participants (mean age: 43 to 61 years; 656 men and 478 women were reported). Six trials examined the effects of dietary intervention (low-calorie diet) in 499 obese participants (mean age: 44.3 to 61 years; where reported, 395 had moderate-to-severe psoriasis). One trial assessed a combined dietary intervention and exercise programme in 303 obese participants with moderate-to-severe psoriasis who had started a systemic therapy for psoriasis and had not achieved clearance after four weeks of continuous treatment (median age: 53 years). Another trial assessed a walking exercise and continuous health education in 200 participants (mean age: 43.1 years, severity not reported). Finally, two trials included education programmes promoting a healthy lifestyle in 161 participants (aged 18 to 78 years), with one trial on mild psoriasis and the other trial not reporting severity.Comparisons included information only; no intervention; medical therapy alone; and usual care (such as continuing healthy eating).All trials were conducted in hospitals and treated participants for between 12 weeks and three years. One trial did not report the treatment period. Seven trials measured the outcomes at the end of treatment and there was no additional follow-up. In two trials, there was follow-up after the treatment ended. Five trials had a high risk of performance bias, and four trials had a high risk of attrition bias.We found no trials assessing interventions for alcohol abstinence or smoking cessation. No trials assessed time to relapse. Only two trials assessed adverse events; in one trial these were caused by the add-on therapy ciclosporin (given in both groups). The trial comparing two dietary interventions to a no-treatment group observed no adverse events.The results presented in this abstract are based on trials of obese participants.Outcomes for dietary interventions versus usual care were measured 24 weeks to six months from baseline. Compared to usual care, dietary intervention (strict caloric restriction) may lead to 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) (risk ratio (RR) 1.66, 95% confidence interval (CI) 1.07 to 2.58; 2 trials, 323 participants; low-quality evidence). Adherence to the intervention may be greater with the dietary intervention than usual care, but the 95% CI indicates that the dietary intervention might also make little or no difference (RR 1.26, 95% CI 0.76 to 2.09; 2 trials, 105 participants; low-quality evidence). Dietary intervention probably achieves a greater improvement in dermatology quality-of-life index (DLQI) score compared to usual care (MD -12.20, 95% CI -13.92 to -10.48; 1 trial, 36 participants; moderate-quality evidence), and probably reduces the BMI compared to usual care (MD -4.65, 95% CI -5.93 to -3.36; 2 trials, 78 participants; moderate-quality evidence).Outcomes for dietary interventions plus exercise programme were measured 16 weeks from baseline and are based on one trial (303 participants). Compared to information only (on reducing weight to improve psoriasis), combined dietary intervention and exercise programme (dietetic plan and physical activities) probably improves psoriasis severity, but the 95% CI indicates that the intervention might make little or no difference (PASI 75: RR 1.28, 95% CI 0.83 to 1.98). This combined intervention probably results in a greater reduction in BMI (median change -1.10 kg/m², P = 0.002), but there is probably no difference in adherence (RR 0.95, 95% CI 0.89 to 1.01; 137/151 and 145/152 participants adhered in the treatment and control group, respectively). There were no data on quality of life. These outcomes are based on moderate-quality evidence.
AUTHORS' CONCLUSIONS


Dietary intervention may reduce the severity of psoriasis (low-quality evidence) and probably improves quality of life and reduces BMI (moderate-quality evidence) in obese people when compared with usual care, while combined dietary intervention and exercise programme probably improves psoriasis severity and BMI when compared with information only (moderate-quality evidence). None of the trials measured quality of life.We did not detect a clear difference in treatment adherence between those in the combined dietary intervention and exercise programme group and those given information only (moderate-quality evidence). Adherence may be improved through dietary intervention compared with usual care (low-quality evidence). Participants generally adhered well to the lifestyle interventions assessed in the review.No trials assessed the time to relapse. Trial limitations included unblinded participants and high dropout rate.Future trials should reduce dropouts and include comprehensive outcome measures; they should examine whether dietary intervention with or without an exercise programme is effective in non-obese people with psoriasis, whether an additional exercise programme is more effective than dietary intervention alone, whether the time to relapse prolongs in people who receive dietary intervention with or without exercise programme, and whether smoking cessation and alcohol abstinence are effective in treating psoriasis.",2019,We did not detect a clear difference in treatment adherence between those in the combined dietary intervention and exercise programme group and those given information only (moderate-quality evidence).,"['obese people', '1163 participants (mean age: 43 to 61 years; 656 men and 478 women were reported', 'obese participants', '303 obese participants with moderate-to-severe psoriasis who had started a systemic therapy for psoriasis and had not achieved clearance after four weeks of continuous treatment (median age: 53 years', '161 participants (aged 18 to 78 years), with one trial on mild psoriasis and the other trial not reporting severity', 'non-obese people with psoriasis', '499 obese participants (mean age: 44.3 to 61 years; where reported, 395 had moderate-to-severe psoriasis', 'people diagnosed by a healthcare professional', '200 participants (mean age: 43.1 years, severity not reported']","['education programmes promoting a healthy lifestyle', 'dietary intervention (low-calorie diet', 'dietary intervention with or without an exercise programme', 'combined dietary intervention and exercise programme', 'usual care, dietary intervention (strict caloric restriction', 'Dietary intervention', 'lifestyle changes (either alone or in combination', 'dietary interventions', 'dietary intervention with or without exercise programme', 'walking exercise and continuous health education']","['psoriasis severity and BMI', 'time to relapse', 'psoriasis severity', 'adverse events', ""Quality of life', 'Time to relapse', and 'Reduction in comorbidities"", 'quality of life and reduces BMI (moderate-quality evidence', 'BMI', 'adherence', ""Severity of psoriasis' and 'Adherence to the intervention"", 'Psoriasis Area and Severity Index (PASI 75) (risk ratio (RR', 'quality of life', 'weight to improve psoriasis', 'dermatology quality-of-life index (DLQI) score']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",323.0,0.18573,We did not detect a clear difference in treatment adherence between those in the combined dietary intervention and exercise programme group and those given information only (moderate-quality evidence).,"[{'ForeName': 'Shu-Hua', 'Initials': 'SH', 'LastName': 'Ko', 'Affiliation': 'Department of Nursing, Wei-Gong Memorial Hospital, 128, Shin-I Rd, Toufen, Miaoli, Taiwan, 35159.'}, {'ForeName': 'Ching-Chi', 'Initials': 'CC', 'LastName': 'Chi', 'Affiliation': ''}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': ''}, {'ForeName': 'Shu-Hui', 'Initials': 'SH', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yu-Shiun', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Mei-Ya', 'Initials': 'MY', 'LastName': 'Hsu', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011972.pub2']
1575,31356125,Associations between driving under the influence or riding with an impaired driver and future substance use among adolescents.,"Objective:  Risky driving behaviors among adolescents, such as riding with a drinking or impaired driver (RWID) or driving while under the influence (DUI) of alcohol or drugs, are significant public health concerns. Few studies have examined associations of RWID and DUI with future substance use and problems after controlling for baseline substance use. Given that the DUI/RWDD event may be a teachable moment to prevent future consequences (e.g., when injured or arrested), it is important to understand how this risk behavior relates to subsequent use and problems. This study therefore examined characteristics of adolescents who reported DUI and RWID and assessed their risk of future alcohol and marijuana use and consequences 6 months later.  Methods:  Participants were 668 adolescents aged 12 to 18 (inclusive) recruited at 1 of 4 primary care clinics in Pittsburgh and Los Angeles as part of a larger randomized controlled trial. They completed surveys about their health behaviors at baseline and 6 months after baseline. We examined baseline characteristics of adolescents who reported DUI and RWID and then assessed whether past-year DUI and RWID at baseline were associated with alcohol and marijuana use and consequences 6 months after baseline.  Results:  Fifty-eight percent of participants were female, 56% were Hispanic, 23% were Black, 14% were White, 7% were multiethnic or other, and the average age was 16 years (SD = 1.9). At baseline, participants who reported RWID or DUI were more likely to be older, report past-year use of alcohol and marijuana, and more likely to have an alcohol use disorder or cannabis use disorder versus those who did not report RWID or DUI, respectively. At 6-month follow-up and after controlling for baseline demographics and baseline alcohol use, RWID was associated with more frequent drinking episodes in the past 3 months and greater number of drinks in the past month when they drank heavily. DUI at baseline was associated with more frequent heavy drinking episodes and alcohol and marijuana consequences 6 months later.  Conclusions:  RWID and DUI are significantly associated with greater alcohol and marijuana use over time. This study highlights that teens may be at higher risk for problem substance use in the future even if they ride with someone who is impaired. Prevention and intervention efforts for adolescents need to address both driving under the influence and riding with an impaired driver to prevent downstream consequences.",2019,DUI at baseline was associated with more frequent heavy drinking episodes and alcohol and marijuana consequences 6 months later.  ,"['Fifty-eight percent of participants were female, 56% were Hispanic, 23% were Black, 14% were White, 7% were multiethnic or other, and the average age was 16 years (SD\u2009=\u20091.9', 'adolescents', 'adolescents, such as riding with a drinking or impaired driver (RWID) or driving while under the influence (DUI) of alcohol or drugs', 'Participants were 668 adolescents aged 12 to 18 (inclusive) recruited at 1 of 4 primary care clinics in Pittsburgh and Los Angeles as part of a larger randomized controlled trial']",[],[],"[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],[],668.0,0.0393686,DUI at baseline was associated with more frequent heavy drinking episodes and alcohol and marijuana consequences 6 months later.  ,"[{'ForeName': 'Karen Chan', 'Initials': 'KC', 'LastName': 'Osilla', 'Affiliation': 'a RAND Corporation , Santa Monica , California.'}, {'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Seelam', 'Affiliation': 'a RAND Corporation , Santa Monica , California.'}, {'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Parast', 'Affiliation': 'a RAND Corporation , Santa Monica , California.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': ""D'Amico"", 'Affiliation': 'a RAND Corporation , Santa Monica , California.'}]",Traffic injury prevention,['10.1080/15389588.2019.1615620']
1576,31329470,Driving safety improves after individualized training: An RCT involving older drivers in an urban area.,"Objective:  This study aimed to reproduce the results of a previous investigation on the safety benefits of individualized training for older drivers. We modified our method to address validity and generalizability issues.  Methods:  Older drivers were randomly assigned to one of the 3 arms: (1) education alone, (2) education + on road training, and (3) education + on road + simulator training. Older drivers were recruited from a larger urban community. At the pre- and posttests (separated by 4 to 8 weeks) participants followed driving directions using a Global Positioning System (GPS) navigation system.  Results:  Our findings support the positive influence of individualized on-road training for urban-dwelling older drivers. Overall, driving safety improved among drivers who received on-road training over those who were only exposed to an education session, F(1, 40) = 11.66,  P  = .001 (26% reduction in total unsafe driving actions [UDAs]). Statistically significant improvements were observed on observation UDAs (e.g., scanning at intersections, etc.), compliance UDAs (e.g., incomplete stop), and procedural UDAs (e.g., position in lane).  Conclusion:  This study adds to the growing evidence base in support of individualized older driver training to optimize older drivers' safety and promote continued safe driving.",2019,"Overall, driving safety improved among drivers who received on-road training over those who were only exposed to an education session, F(1, 40) =","['Older drivers were recruited from a larger urban community', 'urban-dwelling older drivers', 'older drivers in an urban area', 'older drivers', 'Methods:  Older drivers']","['individualized older driver training', 'driving directions using a Global Positioning System (GPS) navigation system', 'individualized training', 'education alone, (2) education\u2009+\u2009on road training, and (3) education\u2009+\u2009on road\u2009+\u2009simulator training']","['Overall, driving safety', 'Driving safety', 'observation UDAs (e.g., scanning at intersections, etc.), compliance UDAs (e.g., incomplete stop), and procedural UDAs (e.g., position in lane']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C2350032', 'cui_str': 'Global Positioning Systems'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",,0.019294,"Overall, driving safety improved among drivers who received on-road training over those who were only exposed to an education session, F(1, 40) =","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gagnon', 'Affiliation': 'a School of Psychology, University of Ottawa , Ottawa , Ontario , Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stinchcombe', 'Affiliation': 'a School of Psychology, University of Ottawa , Ottawa , Ontario , Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Curtis', 'Affiliation': 'a School of Psychology, University of Ottawa , Ottawa , Ontario , Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kateb', 'Affiliation': 'a School of Psychology, University of Ottawa , Ottawa , Ontario , Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Polgar', 'Affiliation': 'c School of Occupational Therapy, Western University , London , Ontario , Canada.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Porter', 'Affiliation': 'd Centre on Aging, and Faculty of Kinesiology and Recreation Management, University of Manitoba , Winnipeg , Manitoba , Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bédard', 'Affiliation': 'e Department of Health Sciences, Lakehead University , Thunder Bay , Ontario , Canada.'}]",Traffic injury prevention,['10.1080/15389588.2019.1630826']
1577,31404623,Effects of a diabetes-specific care model for hip fractured older patients with diabetes: A randomized controlled trial.,"OBJECTIVES


To examine the effects of a diabetes-specific care model for hip fractured elderly with diabetes mellitus (DM).
METHODS


A randomized controlled trial was implemented in a 3000-bed medical center in northern Taiwan. Older adults (age ≥ 60) with DM who had hip-fracture surgery (N = 176) were recruited and randomly assigned to diabetes-specific care (n = 88) and usual care (n = 88). Usual care entailed one or two in-hospital rehabilitation sessions. Diabetes-specific care comprised an interdisciplinary care (including geriatric consultation, discharge planning, and in-home rehabilitation) and diabetes-specific care (including dietary and diabetes education, blood pressure control, dyslipidemia management, a glycemic treatment regimen, and rehabilitation exercises). Outcomes including heart rate variability; rehabilitation outcomes; activities of daily living and instrumental activities of daily living were assessed before discharge and 1, 3, 6, 12, 18, 24 months afterwards.
RESULTS


Patients who received diabetes-specific care had significantly higher hip-flexion range of motion (b = 5.24, p < .01), peak-force quadriceps strength of the affected limb (b = 2.13, p < .05), higher total heart rate variability in terms of the time-domain parameter for the mean squared difference between two adjacent normal R-R intervals (b = 11.35, p < .05), and frequency-domain parameters, such as low frequency (b = 42.17, p < .05), and the high frequency-to-low frequency ratio (b = 0.11, p < .01).
CONCLUSIONS


Our diabetes-specific care model enhanced hip-flexion range of motion, peak quadriceps strength of the affected limb, and overall heart rate variability, indicating dynamic responses to environmental changes during the 24 months following hospital discharge, above and beyond the effects of usual care.",2019,"Outcomes including heart rate variability; rehabilitation outcomes; activities of daily living and instrumental activities of daily living were assessed before discharge and 1, 3, 6, 12, 18, 24 months afterwards.
","['3000-bed medical center in northern Taiwan', 'hip fractured elderly with diabetes mellitus (DM', 'Older adults (age\u202f≥\u202f60) with DM who had hip-fracture surgery (N\u202f=\u202f176', 'hip fractured older patients with diabetes']","['diabetes-specific care (n\u202f=\u202f88) and usual care', 'Usual care entailed one or two in-hospital rehabilitation sessions', 'interdisciplinary care (including geriatric consultation, discharge planning, and in-home rehabilitation) and diabetes-specific care (including dietary and diabetes education, blood pressure control, dyslipidemia management, a glycemic treatment regimen, and rehabilitation exercises', 'diabetes-specific care model']","['heart rate variability; rehabilitation outcomes; activities of daily living and instrumental activities of daily living', 'hip-flexion range of motion', 'peak-force quadriceps strength of the affected limb', 'total heart rate variability']","[{'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0012622', 'cui_str': 'Discharge Planning'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0600378', 'cui_str': 'Rehabilitation Outcome'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0340105,"Outcomes including heart rate variability; rehabilitation outcomes; activities of daily living and instrumental activities of daily living were assessed before discharge and 1, 3, 6, 12, 18, 24 months afterwards.
","[{'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Tseng', 'Affiliation': 'Department of Nursing, MeiHo University, 23 Pingguang Road, Neipu, Pingtung 91202, Taiwan. Electronic address: x00003171@meiho.edu.tw.'}, {'ForeName': 'Jersey', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'School of Public Health, University of Michigan, 1420 Washington Heights, SPH II M3007, Ann Arbor, MI 48109, USA. Electronic address: jliang@umich.edu.'}, {'ForeName': 'Jong-Shyan', 'Initials': 'JS', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Rehabilitation Science, College of Medicine, and Healthy Aging Research Center, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan. Electronic address: s5492@mail.cgu.edu.tw.'}, {'ForeName': 'Ching-Tzu', 'Initials': 'CT', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan. Electronic address: ctyang1@livemail.tw.'}, {'ForeName': 'Chi-Chuan', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedic Surgery, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan. Electronic address: ccwu@mail.cgu.edu.tw.'}, {'ForeName': 'Huey-Shinn', 'Initials': 'HS', 'LastName': 'Cheng', 'Affiliation': 'Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan. Electronic address: hscheng@adm.cgmh.org.tw.'}, {'ForeName': 'Ching-Yen', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Keelung Chang Gung Memorial Hospital, No. 200, Lane 208, Jijin 1st Road, Anle District, Keelung 20445, Taiwan. Electronic address: psycychen@yahoo.com.tw.'}, {'ForeName': 'Yueh-E', 'Initials': 'YE', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan. Electronic address: amy436643@adm.cgmh.org.tw.'}, {'ForeName': 'Woan-Shyuan', 'Initials': 'WS', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan. Electronic address: shuan@mail.cgu.edu.tw.'}, {'ForeName': 'Yea-Ing L', 'Initials': 'YL', 'LastName': 'Shyu', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan; Department of Orthopedic Surgery, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan; Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, 123 Dapi Road, Niaosng District, Kaohsiung 83301, Taiwan; Department of Gerontology and Health Care Management, Chang Gung University of Science and Technology, 261 Wenhwa 1st Road, Guishan District, Taoyuan 33303, Taiwan. Electronic address: yeaing@mail.cgu.edu.tw.'}]",Experimental gerontology,['10.1016/j.exger.2019.110689']
1578,31356921,Oral Janus kinase/SYK inhibition (ASN002) suppresses inflammation and improves epidermal barrier markers in patients with atopic dermatitis.,"BACKGROUND


Moderate-to-severe atopic dermatitis (AD) has been associated with significant disease burden and systemic abnormalities and often requires systemic treatments. Currently, safe and effective oral systemic treatments for moderate-to-severe AD are not yet available. ASN002 is an oral inhibitor of the Janus kinase/spleen tyrosine kinase signaling pathways, targeting several cytokine axes (T H 2/T H 22/T H 17/T H 1) and epidermal differentiation.
OBJECTIVE


We sought to evaluate the effect of ASN002 on the cellular and molecular biomarker profile of patients with moderate-to-severe AD and to correlate changes in biomarkers to improvements in clinical severity measures and pruritus.
METHODS


Thirty-six patients with moderate-to-severe AD were randomized to groups with dose escalation of ASN002 (20, 40, and 80 mg) and a placebo group. Skin biopsy specimens were performed at baseline, day 15, and day 29. Gene expression studies were conducted by using microarray and quantitative RT-PCR, and cellular infiltrates and protein expression were studied by using immunohistochemistry.
RESULTS


ASN002 reversed the lesional skin transcriptome toward a nonlesional phenotype. It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/IL36RN), and T H 1 (IFNG, CXCL9/CXCL11, and MX1) axes and barrier-related measures (filaggrin [FLG] and CLDN23). Significant improvements in AD gene signatures were observed predominantly in the 40- and 80-mg groups. Smaller and largely nonsignificant molecular changes were seen in the 20-mg and placebo groups.
CONCLUSION


The Janus kinase/spleen tyrosine kinase inhibitor ASN002 significantly suppressed key AD inflammatory pathways, corresponding to clinical response. ASN002 might be an effective novel therapeutic agent for moderate-to-severe AD.",2019,"It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/","['Thirty-six patients with moderate-to-severe AD', 'patients with moderate-to-severe AD', 'patients with atopic dermatitis']","['Oral Janus kinase/SYK inhibition (ASN002', 'ASN002', 'placebo']","['IL36RN), and T H 1 (IFNG, CXCL9/CXCL11, and MX1) axes and barrier-related measures', 'AD gene signatures', 'T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G', 'lesional skin transcriptome', 'epidermal barrier markers']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0123771', 'cui_str': 'Receptors, IL-4'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C1959608', 'cui_str': 'TARC Chemokine'}, {'cui': 'C4319742', 'cui_str': 'Macrophage Inflammatory Protein 4'}, {'cui': 'C1098076', 'cui_str': 'Macrophage-Derived Chemokine'}, {'cui': 'C4476471', 'cui_str': 'Chemokine CCL26'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C1579194', 'cui_str': 'Protease Inhibitor WAP3'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C3178810', 'cui_str': 'Transcriptome'}]",36.0,0.0336823,"It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/","[{'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hyun-Je', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Del Duca', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, NY.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Dubin', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Yeriel D', 'Initials': 'YD', 'LastName': 'Estrada', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Denis', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Rao', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Zammit', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: emma.guttman@mountsinai.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.07.013']
1579,18595465,[Dysbiotic manifestations during eradication therapy of Helicobacter pylori and their corrections].,"Forty-eight patients with duodenal peptic ulcer disease infected with Helicobacter pylori were examined. All patients undergo conventional 1-week eradication therapy. After its ending the patients were randomized to two groups: those who will be treated by synbiotics or control group. Normoflorin B and Normoflorin L, which contain bifidobacteria or lactobacilli in complex with different microelements, vitamins, aminoacids, organic acids, and antioxidants, were used as synbiotics. Morphologic study of biopsy samples of small intestine mucosa were performed in patients from both groups. It was determined that eradication therapy worsened existing symptoms of dyspepsia in 80.9% of cases or lead to their emergence, connected with dysbiotic manifestations, in 55.5% of patients. Inclusion of synbiotics in complex therapy resulted in rapid and effective elimination of dyspeptic symptoms, promoted recovery of affected morphologic and functional states of small intestine mucosal epithelium, and optimized metabolic processes important for the digestion.",2008,"Inclusion of synbiotics in complex therapy resulted in rapid and effective elimination of dyspeptic symptoms, promoted recovery of affected morphologic and functional states of small intestine mucosal epithelium, and optimized metabolic processes important for the digestion.",['Forty-eight patients with duodenal peptic ulcer disease infected with Helicobacter pylori'],[],[],"[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",[],[],48.0,0.0156226,"Inclusion of synbiotics in complex therapy resulted in rapid and effective elimination of dyspeptic symptoms, promoted recovery of affected morphologic and functional states of small intestine mucosal epithelium, and optimized metabolic processes important for the digestion.","[{'ForeName': 'E Iu', 'Initials': 'EIu', 'LastName': 'Eremina', 'Affiliation': ''}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Bondarenko', 'Affiliation': ''}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Zvereva', 'Affiliation': ''}, {'ForeName': 'O I', 'Initials': 'OI', 'LastName': 'Nikitina', 'Affiliation': ''}, {'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Shaposhnikova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1580,32441458,"Upper-airway collapsibility and compensatory responses under moderate sedation with ketamine, dexmedetomidine, and propofol in healthy volunteers.","BACKGROUND


Ketamine is a potent sedative drug that helps to maintain upper-airway patency, due to its higher upper-airway dilator muscular activity and higher level of duty cycle, as seen in rats. However, no clinical trials have tested passive upper-airway collapsibility and changes in the inspiratory duty cycle against partial upper-airway obstruction in humans. The present study evaluated both the passive mechanical upper-airway collapsibility and compensatory response against acute partial upper-airway obstruction using three different sedative drugs in a crossover trial.
METHODS


Eight male volunteers entered this nonblinded, randomized crossover study. Upper-airway collapsibility (passive critical closing pressure) and inspiratory duty cycle were measured under moderate sedation with ketamine, propofol, and dexmedetomidine. Propofol, dexmedetomidine, and ketamine anesthesia were induced to obtain adequate, same-level sedation, with a BIS value of 50-70 and the OAA/S score of 2-3 and RASS score of -3.
RESULTS


The median passive critical closing pressure of 0.08 [-5.51 to 1.20] cm H 2  O was not significantly different compared to that of propofol sedation (-0.32 [-1.41 to -0.19] cm H 2  O) and of dexmedetomidine sedation (-0.28 [-0.95 to -0.03] cm H 2  O) (p = .045). The median passive R US  for ketamine 54.35 [32.00 to 117.50] cm H 2  O/L/s was significantly higher than that for propofol 5.50 [2.475 to 19.60] cm H 2  O/L/s; (mean difference, 27.50; 95% CI 9.17 to 45.83) (p = .009) and for dexmedetomidine 19.25 [4.125 to 22.05] cm H 2  O/L/s; (mean difference, 22.88; 95% CI 4.67 to 41.09) (p = .021). The inspiratory duty cycle increased significantly as the inspiratory airflow decreased in passive conditions for each sedative drug, but behavior differed among the three sedative drugs.
CONCLUSION


Our findings demonstrate that ketamine sedation may have an advantage of both maintained passive upper-airway collapsibility and a compensatory respiratory response, due to both increase in neuromuscular activity and the increased duty cycle, to acute partial upper-airway obstruction.",2020,O was not significantly different compared to that of propofol sedation (-0.32,"['healthy volunteers', 'Eight male volunteers']","['ketamine', 'Ketamine', 'Propofol, dexmedetomidine, and ketamine anesthesia', 'ketamine, dexmedetomidine, and propofol', 'passive mechanical upper-airway collapsibility and compensatory response against acute partial upper-airway obstruction', 'propofol', 'dexmedetomidine', 'ketamine, propofol, and dexmedetomidine']","['median passive R US', 'Upper-airway collapsibility (passive critical closing pressure) and inspiratory duty cycle', 'inspiratory duty cycle', 'median passive critical closing pressure', 'inspiratory airflow', 'dexmedetomidine sedation', 'neuromuscular activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",8.0,0.0335115,O was not significantly different compared to that of propofol sedation (-0.32,"[{'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",Physiological reports,['10.14814/phy2.14439']
1581,10356736,"[The results of the registration clinical trials of the Act-Hib vaccine manufactured by the firm of Pasteur Mérieux Connaught, France].","The results of the field trials of the vaccine ""Act-Hib"" against Haemophilus influenzae of type b, presented for registration by Pasteur Mérieux Connaught (France), are summarized. The vaccine was found to have low reactogenicity and high immunological effectiveness. A single injection of the vaccine induced the formation of the protective level of anti-PRP antibodies in 94% of the immunized children aged 1-4 years. After immunization the mean geometric titers of specific antibodies increased sixfold in comparison with the initial level and were equal to 3.4 mu/ml. On the basis of the data of laboratory control and field clinical trials the vaccine ""Act-Hib"" was registered in the Russian Federation and permission and its practical use in the public health service of the country was permitted.",1999,After immunization the mean geometric titers of specific antibodies increased sixfold in comparison with the initial level and were equal to 3.4 mu/ml.,[],['vaccine'],"['protective level of anti-PRP antibodies', 'mean geometric titers of specific antibodies']",[],"[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}]",,0.045657,After immunization the mean geometric titers of specific antibodies increased sixfold in comparison with the initial level and were equal to 3.4 mu/ml.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gorbunov', 'Affiliation': 'Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations, Moscow, Russia.'}, {'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Pavlova', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Chuprinina', 'Affiliation': ''}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Nemirovskaia', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1582,31438807,Extending the use of routine outcome monitoring: Predicting long-term outcomes in cognitive behavioral therapy for severe health anxiety.,"Objective:  Routine outcome monitoring (ROM) is a well-evidenced means of improving psychotherapy's effectiveness. However, it is unclear how meaningful ROM is for problems that span physical and mental health, such as severe health anxiety. Physical and mental health comorbidities are common amongst severe health anxiety sufferers and cognitive behavioral therapy (CBT) is a recommended treatment.  Method:  Seventy-nine participants received CBT for severe health anxiety in a clinical trial. The Outcome Rating Scale (ORS: a ROM assessment of wellbeing) was completed at each session. Multilevel modeling assessed whether last-session ORS predicted health anxiety and other outcomes over 12-month follow-up. Similar models were developed using health anxiety as a comparative outcome-predictor. Outcome-improvements of treatment-responders with sudden gains were compared to those of non-sudden-gainers.  Results:  Last-session ORS scores predicted all outcomes up to 12 months later, with a comparable predictive effect to health anxiety. Sudden-gainers on the ORS reported significantly greater improvement in depression, functioning, and wellbeing, but no difference in health anxiety or other measures.  Conclusion:  The ORS may be a feasible, overall estimate of health, functioning, and quality of life in psychotherapy for severe health anxiety. Sudden gains on the ORS may be clinically meaningful with respect to some long-term outcomes.",2020,"Sudden-gainers on the ORS reported significantly greater improvement in depression, functioning, and wellbeing, but no difference in health anxiety or other measures.  ","['Method:  Seventy-nine participants received', 'severe health anxiety']","['cognitive behavioral therapy (CBT', 'cognitive behavioral therapy', 'CBT']","['Outcome Rating Scale (ORS: a ROM assessment of wellbeing', 'severe health anxiety', 'depression, functioning, and wellbeing', 'health anxiety', 'Outcome-improvements of treatment-responders with sudden gains']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C4273786', 'cui_str': 'Outcome Rating Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}]",79.0,0.0496876,"Sudden-gainers on the ORS reported significantly greater improvement in depression, functioning, and wellbeing, but no difference in health anxiety or other measures.  ","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Malins', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Moghaddam', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morriss', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schröder', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1657250']
1583,31044733,"How to Prevent Retinal Shift after Rhegmatogenous Retinal Detachment Repair: A Prospective, Randomized Study.","PURPOSE


To evaluate the effect of intraoperative use of heavy liquid on retinal shift after retinal detachment repair.
DESIGN


Prospective, randomized study.
PARTICIPANTS


Patients who underwent pars plana vitrectomy for macula-off rhegmatogenous retinal detachment were included in the current study.
METHODS


Patients were randomized into 2 groups: group A included patients in whom heavy liquid was used during the procedure and group B included patients in whom no heavy liquid was used. Group A and B patients were reviewed after 3 weeks and after 6 weeks, respectively, and fundus autofluorescence (FAF) images were obtained to visualize the retinal rotation.
MAIN OUTCOME MEASURE


Postoperative macular shift, visualized with FAF.
RESULTS


A total of 50 eyes from 49 patients were included. Overall, retinal shift was observed in 17 patients (34%). Patients in whom heavy liquid was used during the procedure showed significantly less macular shift after surgery (P = 0.049). There was a strong association between retinal shift and postoperative symptoms of metamorphopsia. Ten of 17 patients with retinal shift reported distorted vision (P < 0.001).
CONCLUSIONS


The use of intraoperative heavy liquid seems to be associated with lower occurrence of retinal shift after retinal detachment repair.",2019,Patients in whom heavy liquid was used during the procedure showed significantly less macular shift after surgery (P = 0.049).,"['Patients who underwent', 'for macula-off rhegmatogenous retinal detachment were included in the current study', 'A total of 50 eyes from 49 patients were included', 'after Rhegmatogenous Retinal Detachment Repair', 'Patients were randomized into 2 groups: group A included patients in whom']","['pars plana vitrectomy', 'Retinal Shift', 'heavy liquid']","['distorted vision', 'Postoperative macular shift, visualized with FAF', 'Overall, retinal shift', 'macular shift']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332573', 'cui_str': 'Macule (morphologic abnormality)'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",50.0,0.0310783,Patients in whom heavy liquid was used during the procedure showed significantly less macular shift after surgery (P = 0.049).,"[{'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Guber', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, Sankt Gallen, Switzerland; Department of Ophthalmology, University of Basel, Basel, Switzerland. Electronic address: josef_guber@hotmail.com.'}, {'ForeName': 'Megir', 'Initials': 'M', 'LastName': 'Schawkat', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, Sankt Gallen, Switzerland.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, Sankt Gallen, Switzerland.'}, {'ForeName': 'Hendrik P N', 'Initials': 'HPN', 'LastName': 'Scholl', 'Affiliation': 'Institute of Molecular and Clinical Ophthalmology, Basel, Switzerland; Department of Ophthalmology, University of Basel, Basel, Switzerland; Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Valmaggia', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, Sankt Gallen, Switzerland.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.01.010']
1584,31728713,"Analysis of autonomic outcomes in APOLLO, a phase III trial of the RNAi therapeutic patisiran in patients with hereditary transthyretin-mediated amyloidosis.","Hereditary transthyretin-mediated (hATTR) amyloidosis is a progressive, debilitating disease often resulting in early-onset, life-impacting autonomic dysfunction. The effect of the RNAi therapeutic, patisiran, on autonomic neuropathy manifestations in patients with hATTR amyloidosis with polyneuropathy in the phase III APOLLO study is reported. Patients received patisiran 0.3 mg/kg intravenously (n = 148) or placebo (n = 77) once every 3 weeks for 18 months. Patisiran halted or reversed polyneuropathy and improved quality of life from baseline in the majority of patients. At baseline, patients in APOLLO had notable autonomic impairment, as demonstrated by the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain. At 18 months, patisiran improved autonomic neuropathy symptoms compared with placebo [COMPASS-31, least squares (LS) mean difference, - 7.5; 95% CI: - 11.9, - 3.2; Norfolk QOL-DN autonomic neuropathy domain, LS mean difference, - 1.1; - 1.8, - 0.5], nutritional status (modified body mass index, LS mean difference, 115.7; - 82.4, 149.0), and vasomotor function (postural blood pressure, LS mean difference, - 0.3; - 0.5, - 0.1). Patisiran treatment also led to improvement from baseline at 18 months for COMPASS-31 (LS mean change from baseline, - 5.3; 95% CI: - 7.9, - 2.7) and individual domains, orthostatic intolerance (- 4.6; - 6.3, - 2.9) and gastrointestinal symptoms (- 0.8; - 1.5, - 0.2). Rapid worsening of all study measures was observed with placebo, while patisiran treatment resulted in stable or improved scores compared with baseline. Patisiran demonstrates benefit across a range of burdensome autonomic neuropathy manifestations that deteriorate rapidly without early and continued treatment.",2020,"At baseline, patients in APOLLO had notable autonomic impairment, as demonstrated by the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain.","['patients with hATTR amyloidosis with polyneuropathy in the phase III APOLLO study', 'patients with hereditary transthyretin-mediated amyloidosis']","['placebo', 'patisiran 0.3\xa0mg/kg intravenously (n\u2009=\u2009148) or placebo']","['Patisiran halted or reversed polyneuropathy and improved quality of life', 'gastrointestinal symptoms', 'individual domains, orthostatic intolerance', 'notable autonomic impairment', 'autonomic neuropathy symptoms', 'Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain', 'vasomotor function (postural blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0034380'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0454866', 'cui_str': 'Norfolk (geographic location)'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}, {'cui': 'C0232365', 'cui_str': 'Vasomotor function (observable entity)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.127789,"At baseline, patients in APOLLO had notable autonomic impairment, as demonstrated by the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain.","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'González-Duarte', 'Affiliation': 'Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Sección XVI, Tlalpan, CdMx, CP 01400, México City, Mexico. gonzalezduarte@aol.com.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Quan', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Hartmut H', 'Initials': 'HH', 'LastName': 'Schmidt', 'Affiliation': 'University of Münster, Münster, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Hospital Universitário Clementino Fraga Filho-UFRJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Ueda', 'Affiliation': 'Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Isabel M', 'Initials': 'IM', 'LastName': 'Conceição', 'Affiliation': 'CHULN, Hospital de Santa Maria and Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Hospital de Santo António, Centro Hospitalar Universitário Do Porto, Porto, Portugal.'}, {'ForeName': 'Cécile A', 'Initials': 'CA', 'LastName': 'Cauquil', 'Affiliation': 'AP-HP Université Paris Saclay, CHU Bicêtre, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Tard', 'Affiliation': 'Université de Lille, Lille, France.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Merkel', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Aldinc', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Adams', 'Affiliation': 'AP-HP, Université Paris Saclay, CHU Bicêtre, Université Paris-Sud, INSERM 1195, Paris, France.'}]",Journal of neurology,['10.1007/s00415-019-09602-8']
1585,32441473,Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.,"OBJECTIVE


The obesity epidemic is a public health concern, warranting further research into pharmacological treatments for weight management (WM) as an adjunct to lifestyle interventions. The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
METHODS


Across five phase 3 trials (NCT03548935, WM; NCT03552757, WM in type 2 diabetes; NCT03611582, WM with intensive behavioral therapy; NCT03548987, sustained WM; and NCT03693430, long-term WM), ~5,000 participants are being randomly assigned to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results will be available in 2020/2021. For all trials, the primary end point is change from baseline to end of treatment in body weight.
RESULTS


Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2  and a mean waist circumference of 113.0 to 115.7 cm.
CONCLUSIONS


The STEP program evaluates the efficacy and safety of semaglutide 2.4 mg subcutaneously once weekly in a broad population. The trials will provide insights on WM in people with obesity with and without type 2 diabetes and on long-term follow-up.",2020,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
","['Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2  and a mean waist circumference of 113.0 to 115.7 cm', '5,000 participants', 'people with obesity with and without type 2 diabetes and on long-term follow-up', 'adults with obesity or overweight', 'People with obesity (STEP) program']","['semaglutide 2.4 mg once weekly subcutaneously versus placebo', 'semaglutide versus placebo']","['body weight', 'efficacy and safety', 'weight loss, safety, and tolerability']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0600766,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
","[{'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Division of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Calanna', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Department of Internal Medicine, Hasharon Hospital Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology, UT Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Wharton', 'Affiliation': 'York University and Wharton Weight Management Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22794']
1586,32441474,Impact of Combined Hormonal Contraceptive Use on Weight Loss: A Secondary Analysis of a Behavioral Weight-Loss Trial.,"OBJECTIVE


This study aimed to perform a preliminary investigation of the impact of combined hormonal contraceptive (CHC) use on weight loss during an 18-month behavioral weight-loss trial.
METHODS


Adults (n = 170; 18-55 years; BMI 27-42 kg/m 2  ) received a weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support. Premenopausal women (n = 110) were classified as CHC users (CHC, n = 17) or non-CHC users (non-CHC, n = 93). Changes in weight were examined within groups using a linear mixed model, adjusted for age and randomized group assignment.
RESULTS


At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg). Between 6 and 18 M, CHC regained weight (4.9 kg; 0.9 to 8.9 kg), while weight remained relatively unchanged in non-CHC (-0.1 kg; -1.8 to 1.6 kg). At 18 M, weight was relatively unchanged from baseline in CHC (-1.8 kg; -7.3 to 3.6 kg) and was reduced from baseline in non-CHC (-7.9 kg; -10.2 to -5.5 kg).
CONCLUSIONS


In this secondary data analysis, CHC use was associated with weight regain after initial weight loss. Prospective studies are needed to further understand the extent to which CHC use influences weight loss and maintenance.",2020,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","['Adults (n\u2009=\u2009170; 18-55 years; BMI 27-42 kg/m 2  ', 'Premenopausal women (n\u2009=\u2009110) were classified as CHC users (CHC, n\u2009=\u200917) or non-CHC users (non-CHC, n\u2009=\u200993']","['combined hormonal contraceptive (CHC', 'Combined Hormonal Contraceptive', 'weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support']","['weight regain', 'weight loss', 'CHC regained weight', 'Weight Loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",,0.0745885,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","[{'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Adnin', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Ostendorf', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Bryan B', 'Initials': 'BB', 'LastName': 'Swanson', 'Affiliation': 'Department of Chemistry and Biochemistry, Colorado College, Colorado Springs, Colorado, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Kinesiology and Public Health Department, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Catenacci', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22787']
1587,9783399,[The choice of the optimal schedules in the vaccination procedure against influenza in elderly subjects].,"To improve the vaccinal prophylaxis of influenza, the comparative study of live trivalent influenza allantoic vaccine, dried, for adults, produced by the Irkutsk Enterprise for Immunological Preparations (Russia), and inactivated trivalent influenza split vaccine, obtained from Wyeth-Ayerst Company (USA), as well as schedules of their combined use for the vaccination of elderly persons, was carried out. The examination of 600 subjects revealed that the vaccines were well tolerated; the combined use of these two vaccines, as well as the use of the inactivated influenza vaccine (IIV) alone, ensured high immunogenic activity (60.0-80.0% of seroconversions). The live influenza vaccine (LIV) stimulated the production of specific antibodies only in 19.0-35.0% of the vaccinees; most of these vaccinees exhibited positive reaction only to one of the vaccine strains. Following the injection of LIV, the level of postvaccinal immunity was retained for at least 6 months. In the vaccinees receiving both vaccines the tendency towards a decrease in mean geometric titer values was less pronounced (0.2-0.4 log2) than in those receiving only IIV (0.5-0.7 log2). At the period of the rise of influenza morbidity, the contamination rate in the vaccinees with the positive postvaccinal dynamics of antibodies was low (26.0%). The indices of effectiveness were 3.8 for combined vaccination, 3.5 for IIV and 2.6 for LIV. The schedule of vaccination with IIV with the possible revaccination LIV 3-4 weeks later was recommended.",1998,The live influenza vaccine (LIV) stimulated the production of specific antibodies only in 19.0-35.0% of the vaccinees; most of these vaccinees exhibited positive reaction only to one of the vaccine strains.,"['elderly persons', 'elderly subjects']",[],"['contamination rate', 'tolerated', 'influenza morbidity', 'immunogenic activity', 'level of postvaccinal immunity', 'production of specific antibodies', 'mean geometric titer values']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0033268'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0154818,The live influenza vaccine (LIV) stimulated the production of specific antibodies only in 19.0-35.0% of the vaccinees; most of these vaccinees exhibited positive reaction only to one of the vaccine strains.,"[{'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Burtseva', 'Affiliation': 'Ivanovsky Research Institute of Virology, Moscow, Russia.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Slepushkin', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Beliaev', 'Affiliation': ''}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Kolobukhina', 'Affiliation': ''}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Merkulova', 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Boltenko', 'Affiliation': ''}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Stepnova', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Beregovskiĭ', 'Affiliation': ''}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Rudenko', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1588,32441471,Effect of Plain Versus Sugar-Sweetened Breakfast on Energy Balance and Metabolic Health: A Randomized Crossover Trial.,,2020,,[],['Plain Versus Sugar-Sweetened Breakfast'],['Energy Balance and Metabolic Health'],[],"[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.070632,,[],"Obesity (Silver Spring, Md.)",['10.1002/oby.22847']
1589,31446994,"Safety and efficacy of pembrolizumab monotherapy in elderly patients with PD-L1-positive advanced non-small-cell lung cancer: Pooled analysis from the KEYNOTE-010, KEYNOTE-024, and KEYNOTE-042 studies.","OBJECTIVES


Most lung cancer diagnoses occur in elderly patients, who are underrepresented in clinical trials. We present a pooled analysis of safety and efficacy in elderly patients (≥75 years) who received pembrolizumab (a programmed death 1 inhibitor) for advanced non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1)‒positive tumors.
METHODS


The pooled analysis included patients aged ≥18 years with advanced NSCLC with PD-L1-positive tumors from the KEYNOTE-010 (NCT01905657), KEYNOTE-024 (NCT02142738), and KEYNOTE-042 (NCT02220894) studies. In KEYNOTE-010, patients were randomized to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and KEYNOTE-042, patients were randomized to first-line pembrolizumab 200 mg Q3W or platinum-based chemotherapy. Overall survival (OS) was estimated by the Kaplan-Meier method, and safety data were summarized in elderly patients (≥75 years).
RESULTS


The analysis included 264 elderly patients with PD-L1-positive tumors (PD-L1 tumor proportion score [TPS] ≥1%); among these, 132 had PD-L1 TPS ≥ 50%. Pembrolizumab improved OS among elderly patients with PD-L1 TPS ≥ 1% (hazard ratio [HR], 0.76 [95% CI, 0.56-1.02]) and PD-L1 TPS ≥ 50% (HR, 0.40 [95% CI, 0.25-0.64]). Pembrolizumab as first-line therapy also improved OS among elderly patients with PD-L1 TPS ≥ 50% (from KEYNOTE-024 and KEYNOTE-042) compared with chemotherapy (HR, 0.41 [95% CI, 0.23‒0.73]). Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy. Immune-mediated AEs and infusion reactions were more common with pembrolizumab versus chemotherapy (overall, 24.8% vs 6.7%; grade 3‒4: 9.4% vs 0%; no grade 5 events).
CONCLUSIONS


In this pooled analysis of elderly patients with advanced NSCLC with PD-L1‒positive tumors, pembrolizumab improved OS versus chemotherapy, with a more favorable safety profile. Outcomes with pembrolizumab in patients ≥75 years were comparable to those in the overall populations in the individual studies.",2019,"Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy.","['a programmed death 1 inhibitor) for advanced non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1)‒positive tumors', 'elderly patients (≥75 years) who received', '264 elderly patients with PD-L1-positive tumors (PD-L1 tumor proportion score [TPS] ≥1%); among these, 132 had PD-L1 TPS\u202f≥\u202f50', 'elderly patients with advanced NSCLC with PD-L1‒positive tumors', 'patients aged ≥18 years with advanced NSCLC with PD-L1-positive tumors', 'elderly patients (≥75 years', 'elderly patients', 'elderly patients with PD-L1-positive advanced non-small-cell lung cancer', 'patients ≥75 years']","['pembrolizumab versus chemotherapy', 'Pembrolizumab', 'pembrolizumab', 'pembrolizumab improved OS versus chemotherapy', 'pembrolizumab monotherapy', 'pembrolizumab 200\u2009mg Q3W or platinum-based chemotherapy', 'pembrolizumab 2 or 10\u2009mg/kg every 3 weeks (Q3W) or docetaxel, as second- or later-line therapy']","['Safety and efficacy', 'Immune-mediated AEs and infusion reactions', 'Overall survival (OS', 'safety and efficacy']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",264.0,0.245098,"Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy.","[{'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Nosaki', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Minami-ku, Fukuoka-shi, Fukuoka 811-1395, Japan. Electronic address: knosaki@east.ncc.go.jp.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan. Electronic address: hideosaka@me.com.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan. Electronic address: yhosomi@cick.jp.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'The Netherlands Cancer Institute, Postbus 90203, 1006 BE Amsterdam, the Netherlands. Electronic address: p.baas@nki.nl.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, Av. Dr. Arnaldo, 251 - Cerqueira César, São Paulo, SP 01246-000, Brazil. Electronic address: gilberto.castro@usp.br.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Wöhrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangdong, 106 Zhongshan 2nd Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng 510080, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Baltimore, 21287 MD, USA. Electronic address: brahmju@jhmi.edu.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital, P. Vall d'Hebron, 119-129, 08035 and IOB Quiron, Barcelona, Spain. Electronic address: efelip@vhio.net.""}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sawada', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: takeshi.sawada@merck.com.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Noguchi', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: kazuo.noguchi@merck.com.'}, {'ForeName': 'Shi Rong', 'Initials': 'SR', 'LastName': 'Han', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: shi.rong.han@merck.com.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: bilal.piperdi@merck.com.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Kush', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: debra_kush@merck.com.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Lopes', 'Affiliation': 'Sylvester Comprehensive Cancer Center at the University of Miami, 1475 NW 12th Ave, Miami, FL 33136, USA. Electronic address: glopes.md@gmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.07.004']
1590,30098860,Comparison of DEXA and Bioimpedance for Body Composition Measurements in Nondialysis Patients With CKD.,"OBJECTIVES


The aims of this study are (1) to compare dual-energy X-ray absorptiometry (DEXA) and bioimpedance for body composition measurements in nondialysis patients with chronic kidney disease, and (2) to investigate factors associated with any measurement differences.
DESIGN AND METHODS


This is a substudy using some baseline data from a randomized controlled clinical trial. One hundred twenty patients (aged 65 ± 14 years) with a measured glomerular filtration rate 8 to 55 mL/min/1.73m 2 , not on renal replacement therapy, irrespective of age and number of comorbidities, were included from 2011 to 2016. For DEXA measurements, Lunar Prodigy or Lunar iDXA were used. For bioimpedance measurements, body composition monitor (BCM) was used. Glomerular filtration rate was measured with iohexol clearance. Data were analyzed using R software. Bland-Altman analysis was performed to compare the 2 measurements. The measurement difference was DEXA minus BCM. Multiple linear regression analysis was performed to analyze relationships between variables.
RESULTS


The estimation of fat-free mass was higher using BCM than DEXA, with a mean difference of -2.8 kg and limits of agreement (mean ± 2 SD) ranging from -12 kg to 6.5 kg. The estimation of fat mass was lower using BCM than DEXA, with a mean difference of 3.1 kg and limits of agreement (mean ± 2 SD) ranging from -6.8 kg to 13 kg. The measurement differences were significantly related to lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration.
CONCLUSION


Our study showed a limited agreement between DEXA and bioimpedance, indicating that these 2 measurements are not interchangeable in nondialysis patients with chronic kidney disease. Lean tissue index, fat tissue index, and body water might contribute to the measurement differences, while measured glomerular filtration rate is not a factor associated with the measurement differences for body composition. Thus, we suggest that the same measure of body composition be used over time.",2019,"The measurement differences were significantly related to lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration.
","['nondialysis patients with chronic kidney disease', 'nondialysis patients with chronic kidney disease, and (2', 'Nondialysis Patients With CKD', 'One hundred twenty patients (aged 65 ± 14 years) with a measured glomerular filtration rate 8 to 55']","['dual-energy X-ray absorptiometry (DEXA) and bioimpedance', 'DEXA and Bioimpedance']","['lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration', 'estimation of fat mass', 'For DEXA measurements, Lunar Prodigy or Lunar iDXA', 'Lean tissue index, fat tissue index', 'Glomerular filtration rate', 'Body Composition Measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]","[{'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392689', 'cui_str': 'Overhydration (disorder)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0388929', 'cui_str': 'Prodigy'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",120.0,0.084384,"The measurement differences were significantly related to lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration.
","[{'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Nephrology, Faculty of Medicine, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Division of Clinical Chemistry & Pharmacology, Department of Laboratory Medicine, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Clyne', 'Affiliation': 'Nephrology, Faculty of Medicine, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden. Electronic address: naomi.clyne@med.lu.se.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.05.003']
1591,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES


This study investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens.
METHODS


Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5 °C) or history of fever (<14 days) in Thailand and Myanmar.
RESULTS


Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (nine cases, 4.0%). Clinical outcomes were similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared with those with a viral organism (median 18 mg/L, interquartile range [10-49] versus 10 mg/L [≤8-22], p = 0.003), with an area under the curve of 0.65 (95% CI 0.55-0.75).
CONCLUSIONS


Serious bacterial infections requiring antibiotics are an exception rather than the rule in the first line of care. CRP testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised controlled trial was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis Hospital, Department of Medical Microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Maureen H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016']
1592,31325288,"A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study.","BACKGROUND


Mobile health (mHealth) technologies hold great promise in improving the delivery of high-quality health care services. Yet, there has been little research so far applying mHealth technologies in the context of delivering stroke care in resource-limited rural regions.
OBJECTIVE


This study aimed to introduce the design and development of an mHealth system targeting primary health care providers and to ascertain its feasibility in supporting the delivery of a System-Integrated techNology-Enabled Model of cAre (SINEMA) service for strengthening secondary prevention of stroke in rural China.
METHODS


The SINEMA mHealth system was designed by a multidisciplinary team comprising public health researchers, neurologists, and information and communication technology experts. The iterative co-design and development of the mHealth system involved the following 5 steps: (1) assessing the needs of relevant end users through in-depth interviews of stakeholders, (2) designing the functional modules and evidence-based care content, (3) designing and building the system and user interface, (4) improving and enhancing the system through a 3-month pilot test in 4 villages, and (5) finalizing the system and deploying it in field trial, and finally, evaluating its feasibility through a survey of the dominant user group.
RESULTS


From the in-depth interviews of 49 relevant stakeholders, we found that village doctors had limited capacity in caring for village-dwelling stroke patients in rural areas. Primary health care workers demonstrated real needs in receiving appropriate training and support from the mHealth system as well as great interests in using the mHealth technologies and tools. Using these findings, we designed a multifaceted mHealth system with 7 functional modules by following the iterative user-centered design and software development approach. The mHealth system, aimed at 3 different types of users (village doctors, town physicians, and county managers), was developed and utilized in a cluster-randomized controlled trial by 25 village doctors in a resource-limited county in rural China to manage 637 stroke patients between July 2017 and July 2018. In the end, a survey on the usability and functions of the mHealth system among village doctors (the dominant group of users, response rate=96%, 24/25) revealed that most of them were satisfied with the essential functions provided (71%) and were keen to continue using it (92%) after the study.
CONCLUSIONS


The mHealth system was feasible for assisting primary health care providers in rural China in delivering the SINEMA service on the secondary prevention of stroke. Further research and initiatives in scaling up the SINEMA approach and this mHealth system to other resource-limited regions in China and beyond will likely enhance the quality and accessibility of essential secondary prevention among stroke patients.
CLINICALTRIAL


ClinicalTrials.gov NCT03185858; https://clinicaltrials.gov/ct2/show/NCT03185858.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1016/j.ahj.2018.08.015.",2019,The mHealth system was feasible for assisting primary health care providers in rural China in delivering the SINEMA service on the secondary prevention of stroke.,"['stroke patients', 'From the in-depth interviews of 49 relevant stakeholders', 'village-dwelling stroke patients in rural areas', 'stroke in rural China', 'users (village doctors, town physicians, and county managers), was developed and utilized in a cluster-randomized controlled trial by 25 village doctors in a resource-limited county in rural China to manage 637 stroke patients between July 2017 and July 2018']",[],[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",[],[],49.0,0.0942861,The mHealth system was feasible for assisting primary health care providers in rural China in delivering the SINEMA service on the secondary prevention of stroke.,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}, {'ForeName': 'Enying', 'Initials': 'E', 'LastName': 'Gong', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}, {'ForeName': 'Wanbing', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}, {'ForeName': 'Zhuoran', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}, {'ForeName': 'Mengyao', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}, {'ForeName': 'Lijing L', 'Initials': 'LL', 'LastName': 'Yan', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Xu', 'Affiliation': 'Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, China Mobile Communications Corporation, Beijing, China.'}]",JMIR mHealth and uHealth,['10.2196/13503']
1593,31577664,Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.,"BACKGROUND


Breast reconstruction with the deep inferior epigastric perforator (DIEP) flap can be associated with complications such as fat necrosis. The authors' objective was to assess the safety and efficacy of fluorescent angiography with indocyanine green to reduce fat necrosis.
METHODS


The authors designed a parallel, randomized, controlled clinical trial for unilateral breast reconstruction. The poorly vascularized tissues of the DIEP flap were removed based on a clinical evaluation in group 1 and based on angiographic criteria in group 2. The authors recorded the flap dimensions, perfusion in terms of fluorescence intensity, complications, reoperations, and BREAST-Q questionnaire scores for both groups.
RESULTS


The study included a total of 51 patients. The flaps showed no size differences after the tissue was excised. The flaps of group 2 presented higher perfusion rates (p = 0.001). The incidence of fat necrosis was 59.3 percent in group 1 and 8.3 percent in group 2 (p = 0.001). Four cases of partial necrosis were recorded in group 1 (18.2 percent) compared with none in group 2 (0 percent) (p = 0.131). Four patients underwent reoperation in group 1 (14.8 percent) compared with none in group 2 (0 percent) (p = 0.113). The patients in group 2 reported higher scores in all domains of the BREAST-Q.
CONCLUSIONS


Fluorescent angiography with indocyanine green significantly reduced the incidence of fat necrosis without diminishing the flaps' dimensions. The perfusion rates were significantly higher and the patients reported significantly greater satisfaction and quality of life. Fluorescent angiography with indocyanine green may be considered a safe and effective tool to enhance the outcomes of breast reconstruction with the DIEP flap.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, I.",2020,The flaps of group 2 presented higher perfusion rates (p=.001).,['51 patients'],"['fluorescent angiography with indocyanine green (FA-ICG', 'DIEP flap and fluorescent angiography']","['perfusion rates', 'satisfaction and quality of life', 'incidence of fat necrosis', 'partial necrosis', 'flap dimensions, perfusion in terms of fluorescence intensity, complications, reoperations and BREAST-Q questionnaire scores', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0082274', 'cui_str': 'diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015668', 'cui_str': 'Steatonecrosis'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",51.0,0.11374,The flaps of group 2 presented higher perfusion rates (p=.001).,"[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Varela', 'Affiliation': 'Madrid, Spain From the Division of Plastic and Reconstructive Surgery and the Department of Preventive Medicine & Biostatistics, FibHULP/Idipaz Hospital Universitario La Paz.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Casado-Sanchez', 'Affiliation': ''}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Zarbakhsh', 'Affiliation': ''}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diez', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Hernandez-Godoy', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Landin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006393']
1594,9304332,[The immunoprophylaxis of influenza among elderly persons].,"During three seasons at the period of 1992-1996 immunization of elderly persons, living in homes for old people, against influenza with inactivated influenza vaccine (IIV) was carried out. Altogether 856 persons were immunized intranasally, 581 persons constituting the control group. For comparison, 4,825 healthy young adults aged 18-24 years were immunized under similar conditions. The study revealed that the intranasal immunization of elderly persons with IIV, made in two administrations, was safe and stimulated sufficient humoral and secretory immunity: the level of seroconversions was 24.3-41.0% to type A(H1N1) influenza virus, 29.6-50.7% to type A(H3N2) influenza virus, 39.3-59.6% to type B influenza virus; the level of diagnostic IgA conversions was 31-38%. Immunization produced a pronounced prophylactic effect (the effectiveness index 1.6-1.7), as well as decreased the total mortality level by half. The tactics of the immunization of persons from high risk groups against influenza in medical practice is discussed.",1997,"The study revealed that the intranasal immunization of elderly persons with IIV, made in two administrations, was safe and stimulated sufficient humoral and secretory immunity: the level of seroconversions was 24.3-41.0% to type A(H1N1) influenza virus, 29.6-50.7% to type A(H3N2) influenza virus, 39.3-59.6% to type B influenza virus; the level of diagnostic IgA conversions was 31-38%.","['elderly persons with IIV', 'elderly persons, living in homes for old people, against influenza with inactivated influenza vaccine (IIV', 'elderly persons', 'Altogether 856 persons were immunized intranasally, 581 persons constituting the control group', '4,825 healthy young adults aged 18-24 years']",[],"['total mortality level', 'level of diagnostic IgA conversions']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C4517894', 'cui_str': '856 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}]",4825.0,0.0103319,"The study revealed that the intranasal immunization of elderly persons with IIV, made in two administrations, was safe and stimulated sufficient humoral and secretory immunity: the level of seroconversions was 24.3-41.0% to type A(H1N1) influenza virus, 29.6-50.7% to type A(H3N2) influenza virus, 39.3-59.6% to type B influenza virus; the level of diagnostic IgA conversions was 31-38%.","[{'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Marinich', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Paramonova', 'Affiliation': ''}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Erofeeva', 'Affiliation': ''}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Maksakova', 'Affiliation': ''}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Nikolaeva', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Naĭkhin', 'Affiliation': ''}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Kraĭnova', 'Affiliation': ''}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Parkov', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1595,9304342,[The development and clinical evaluation of the probiotic Bifidumbacterin forte].,"A new probiotic ""Bifidumbacterin forte"" containing bifidobacteria immobilized on carbon sorbent has been developed. The results of extensive clinical observation on the use of the preparation in patients (children and adults) with the infectious and surgical pathology of the gastrointestinal tract are presented. The clinico-bacteriological effect thus obtained makes it possible to recommend this new probiotic ""Bifidumbacterin forte"" for medical practice for the complex treatment of children and adults with acute and chronic diseases of the gastrointestinal tract.",1997,"A new probiotic ""Bifidumbacterin forte"" containing bifidobacteria immobilized on carbon sorbent has been developed.","['children and adults with acute and chronic diseases of the gastrointestinal tract', 'patients (children and adults) with the infectious and surgical pathology of the gastrointestinal tract']",['probiotic Bifidumbacterin forte'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030669', 'cui_str': 'Pathology, Surgical'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0604396', 'cui_str': 'bifidumbacterin-forte'}]",[],,0.0151287,"A new probiotic ""Bifidumbacterin forte"" containing bifidobacteria immobilized on carbon sorbent has been developed.","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': ""Grigor'ev"", 'Affiliation': ''}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Bondarenko', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Abramov', 'Affiliation': ''}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Murashova', 'Affiliation': ''}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Feklisova', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Chuprinina', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1596,8820685,[The efficacy of the new bacterial preparation biosporin in treating acute intestinal infections].,"The clinico-laboratory study of the new probiotic Biosporin revealed its effectiveness in the treatment of patients with acute enteric infections. The pronounced curative action of the preparation, manifested by the rapid normalization of stool, the disappearance of abdominal pains and the decrease of dysbiosis in the intestine, was demonstrated. The best results were registered after the administration of Biosporin containing 2 x 10(9) microbial cells (Bacillus subtilis and Bacillus licheniformis). Biosporin was well tolerated by the patients, no side effects were observed. Biosporin is recommended for use in medical practice for the treatment of patients with acute enteric infections.",1996,"Biosporin was well tolerated by the patients, no side effects were observed.",['patients with acute enteric infections'],"['Biosporin', 'new bacterial preparation biosporin', 'probiotic Biosporin']",['tolerated'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0293354', 'cui_str': 'biosporin'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]",[],,0.0168572,"Biosporin was well tolerated by the patients, no side effects were observed.","[{'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Gracheva', 'Affiliation': 'Gabrichevsky Research Institute of Epidemiology and Microbiology, Moscow, Russia.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Gavrilov', 'Affiliation': ''}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': ""Solov'eva"", 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Smirnov', 'Affiliation': ''}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Sorokulova', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Reznik', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Chudnovskaia', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1597,9532686,"[Hep-A-in-Vac, a Russian cultured concentrated inactivated vaccine against hepatitis A].","The results of the study of the reactogenicity, safety and immunological activity of Russian cultural vaccine against hepatitis A are presented. The vaccine was found to have specific safety, moderate reactogenicity and pronounced immunological activity. In addition, the study of the prophylactic efficiency of the vaccine in the pre-epidemic period of the outbreak of hepatitis A morbidity in a group exceeding 14,000 adults was carried out. The study revealed high prophylactic efficiency of the vaccine (its efficiency rate was equal to 97.7%). On the basis of materials thus obtained vaccine ""Hep-A-in-Vac"" was recommended for use in medical practice for the prophylaxis of hepatitis A among adults.",1998,The study revealed high prophylactic efficiency of the vaccine (its efficiency rate was equal to 97.7%).,[],['vaccine'],"['specific safety, moderate reactogenicity and pronounced immunological activity', 'reactogenicity, safety and immunological activity']",[],"[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",14000.0,0.0169677,The study revealed high prophylactic efficiency of the vaccine (its efficiency rate was equal to 97.7%).,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gorbunov', 'Affiliation': 'Tarasevich State Research Institute for Standartization and Control of Medical Biological Preparations, Moscow, Russia.'}, {'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Pavlova', 'Affiliation': ''}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Rozhkov', 'Affiliation': ''}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Kukharev', 'Affiliation': ''}, {'ForeName': 'V Iu', 'Initials': 'VIu', 'LastName': 'Novikov', 'Affiliation': ''}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Karpovich', 'Affiliation': ''}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Kalashnikova', 'Affiliation': ''}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Bektimirov', 'Affiliation': ''}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Zelenov', 'Affiliation': ''}, {'ForeName': 'V D', 'Initials': 'VD', 'LastName': 'Levina', 'Affiliation': ''}, {'ForeName': 'B P', 'Initials': 'BP', 'LastName': 'Belashev', 'Affiliation': ''}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Ermolaeva', 'Affiliation': ''}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Doroshenko', 'Affiliation': ''}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Maĭdaniuk', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1598,31435732,Laparoscopy versus robotic-assisted pyeloplasty in children: preliminary results of a pilot prospective randomized controlled trial.,"PURPOSE


The aim of this randomized controlled trial (RCT) is to compare the outcomes of conventional laparoscopic pyeloplasty (LP) versus robotic-assisted laparoscopic pyeloplasty (RALP) in the treatment of ureteropelvic junction obstruction (UPJO) in children.
METHODS


A total of 53 patients with UPJO were randomized as LP (Group 1, n: 27) and RALP (Group 2, n: 26). Redo cases and patients with anatomical abnormalities were excluded. Urinary ultrasound was performed at postoperative 3, 6 and 12 months; whereas, diuretic renal scintigraphy was performed at 1 year. Failure was defined as progressive hydronephrosis on ultrasound, decline in renal function, or symptom relapse. All parameters were statistically compared.
RESULTS


The mean age of the patients was 55.53 ± 57.25 months. There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel. Mean total operative time in LP group was longer than RALP (139 min vs 105 min, respectively, p = 0.001). The hospital stay was similar between the two groups. After a mean follow-up of 12.43 ± 5.34 months, the complication and success rates were found comparable. Only two patients required re-do pyeloplasty in LP group. The mean total cost of RALP procedure was approximately four times higher than LP.
CONCLUSIONS


This is the first RCT comparing LP and RALP in pediatric population. Both LP and RALP are safe and effective in children with comparable success and complication rates. Operative time was longer for LP; whereas, total cost was higher for RALP.",2020,"There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel.","['children', '53 patients with UPJO', 'ureteropelvic junction obstruction (UPJO) in children', 'pediatric population']","['LP and RALP', 'Laparoscopy versus robotic-assisted pyeloplasty', 'RALP', 'LP', 'diuretic renal scintigraphy', 'conventional laparoscopic pyeloplasty (LP) versus robotic-assisted laparoscopic pyeloplasty (RALP']","['progressive hydronephrosis on ultrasound, decline in renal function, or symptom relapse', 'hospital stay', 'Mean total operative time', 'total cost', 'mean total cost of RALP procedure', 'patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel', 'complication and success rates', 'Operative time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521619', 'cui_str': 'Pelvi-ureteric junction obstruction'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0554139', 'cui_str': 'Reconstruction of ureteropelvic junction (procedure)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0227666', 'cui_str': 'Kidney Pelvis'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0536008,"There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel.","[{'ForeName': 'Mesrur Selcuk', 'Initials': 'MS', 'LastName': 'Silay', 'Affiliation': 'Department of Pediatric Urology, Istanbul Gelisim University & Istanbul Memorial Hospital, Istanbul, Turkey. selcuksilay@gmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Danacioglu', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Ozel', 'Affiliation': 'Department of Pediatric Surgery, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'M Ihsan', 'Initials': 'MI', 'LastName': 'Karaman', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Turhan', 'Initials': 'T', 'LastName': 'Caskurlu', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}]",World journal of urology,['10.1007/s00345-019-02910-8']
1599,31436621,Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial.,"BACKGROUND


Autologous platelet-rich plasma products can significantly vary with respect to platelet concentration, the presence of additional cellularity, and the use of additives. Therefore, the utility of each formulation for treating chronic wounds needs to be established.
OBJECTIVE


To establish the efficacy of up to 12 weeks of treatment with Aurix hematogel for healing diabetic foot ulcers against usual and customary care including any wound modality in 129 patients using a Medicare Coverage with Evidence Development paradigm.
METHODS


This pragmatic randomized controlled trial was conducted in 28 real-world outpatient wound care sites using an inclusive design that included participants with various health risks, comorbidities (eg, peripheral arterial disease, smoking), and any wound severity (Wagner 1-4).
RESULTS


Kaplan-Meier analysis showed a significant (log-rank P = .0476) time-to-heal advantage, with 48.5% of wounds healing with Aurix hematogel compared with 30.2% with usual and customary care. A higher percentage of healing was observed for Aurix across all wound severities (Wagner grade 1-4). Subgroup analysis revealed a significant healing advantage for Aurix when treating wounds accompanied by peripheral arterial disease and a demonstrated advantage for smokers.
CONCLUSIONS


This first Coverage with Evidence Development study in wound care demonstrates the effectiveness of Aurix for treating diabetic foot ulcers in Medicare beneficiaries.",2019,"Subgroup analysis revealed a significant healing advantage for Aurix when treating wounds accompanied by peripheral arterial disease and a demonstrated advantage for smokers.
","['28 real-world outpatient wound care sites using an inclusive design that included participants with various health risks, comorbidities (eg, peripheral arterial disease, smoking), and any wound severity (Wagner 1-4', '129 patients using a Medicare Coverage with Evidence Development paradigm', 'diabetic foot ulcers in Medicare beneficiaries', 'Chronic Diabetic Foot Ulcers']","['Aurix hematogel', 'Aurix Gel']","['healing', ' time-to-heal advantage']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551672', 'cui_str': 'Medicare coverage'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]",129.0,0.133504,"Subgroup analysis revealed a significant healing advantage for Aurix when treating wounds accompanied by peripheral arterial disease and a demonstrated advantage for smokers.
","[{'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Gude', 'Affiliation': ""Warren Gude, MD, is Medical Director, St Luke's Wound and Hyperbaric Clinic; Medical Director, Wound Care at Vibra Hospital; and Medical Director of Wound Care, Meadow View Nursing and Rehabilitation Center, Boise, Idaho. Daniel Hagan, DPM, DABPS, is a podiatrist, Onslow Memorial Hospital Wound Care; and in private practice, Family Foot Care, Jacksonville, North Carolina. Ferial Abood, MD, is Medical Director of Internal Medicine, Advanced Wound Care of South Central New Mexico, Gerald Champion Hospital, Alamogordo, New Mexico. Peter Clausen, PhD, is Chief Science Officer, Nuo Therapeutics Inc, Gaithersburg, Maryland. Acknowledgments: Nuo Therapeutics (Gaithersburg, Maryland) sponsored this study and provided oversight and funding for third-party vendors that supported study operations, data storage, and statistical planning and analysis. Therapies were reimbursed by the Centers for Medicare & Medicaid Services in accordance with Medicare rules.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hagan', 'Affiliation': ''}, {'ForeName': 'Ferial', 'Initials': 'F', 'LastName': 'Abood', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clausen', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000577140.19174.9e']
1600,31609286,"Knowledge and Skills Acquisition by Plastic Surgery Residents through Digital Simulation Training: A Prospective, Randomized, Blinded Trial.","BACKGROUND


Simulation is a standard component of residency training in many surgical subspecialties, yet its impact on knowledge and skills acquisition in plastic surgery training remains poorly defined. The authors evaluated the potential benefits of simulation-based cleft surgery learning in plastic surgery resident education through a prospective, randomized, blinded trial.
METHODS


Thirteen plastic surgery residents were randomized to a digital simulator or textbook demonstrating unilateral cleft lip repair. The following parameters were evaluated before and after randomization: knowledge of surgical steps, procedural confidence, markings performance on a three-dimensional stone model, and surgical performance using a hands-on/high-fidelity three-dimensional haptic model. Participant satisfaction with either educational tool was also assessed. Two expert reviewers blindly graded markings and surgical performance. Intraclass correlation coefficients were calculated. Wilcoxon signed rank and Mann-Whitney U tests were used.
RESULTS


Interrater reliability was strong for preintervention and postintervention grading of markings [preintervention intraclass correlation coefficient, 0.97 (p < 0.001); postintervention intraclass correlation coefficient, 0.96 (p < 0.001)] and surgical [preintervention intraclass correlation coefficient, 0.83 (p = 0.002); postintervention intraclass correlation coefficient, 0.81 (p = 0.004)] performance. Postintervention surgical knowledge (40.3 ± 4.4 versus 33.5 ± 3.7; p = 0.03), procedural confidence (24.0 ± 7.0 versus 14.7 ± 2.3; p = 0.03), markings performance (8.0 ± 2.5 versus 2.9 ± 3.1; p = 0.03), and surgical performance (12.3 ± 2.5 versus 8.2 ± 2.3; p = 0.04) significantly improved in the digital simulation group compared with before intervention, but not in the textbook group. All participants were more satisfied with the digital simulator as an educational tool (27.7 ± 2.5 versus 14.4 ± 4.4; p < 0.001).
CONCLUSION


The authors present evidence suggesting that digital cognitive simulators lead to significant improvement in surgical knowledge, procedural confidence, markings performance, and surgical performance.",2020,"All participants were more satisfied with the digital simulator as an educational tool (27.7±2.5 vs. 14.4±4.4; p<0.001).
","['plastic surgery resident education', 'Thirteen plastic surgery residents', 'Plastic Surgery Residents Through Digital Simulation Training']","['simulation-based cleft surgery learning', 'digital simulator or textbook demonstrating unilateral cleft lip (UCL) repair']","['surgical performance ', 'procedural confidence', 'markings performance', 'surgical knowledge, procedural confidence, markings performance, as well as surgical performance', 'Intra-class correlation coefficients (ICC']","[{'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0392006'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",,0.0954146,"All participants were more satisfied with the digital simulator as an educational tool (27.7±2.5 vs. 14.4±4.4; p<0.001).
","[{'ForeName': 'Rami S', 'Initials': 'RS', 'LastName': 'Kantar', 'Affiliation': 'New York, N.Y. From the Hansjörg Wyss Department of Plastic Surgery, New York University Langone Health.'}, {'ForeName': 'Allyson R', 'Initials': 'AR', 'LastName': 'Alfonso', 'Affiliation': ''}, {'ForeName': 'Elie P', 'Initials': 'EP', 'LastName': 'Ramly', 'Affiliation': ''}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Rifkin', 'Affiliation': ''}, {'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Maliha', 'Affiliation': ''}, {'ForeName': 'J Rodrigo', 'Initials': 'JR', 'LastName': 'Diaz-Siso', 'Affiliation': ''}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Eisemann', 'Affiliation': ''}, {'ForeName': 'Pierre B', 'Initials': 'PB', 'LastName': 'Saadeh', 'Affiliation': ''}, {'ForeName': 'Roberto L', 'Initials': 'RL', 'LastName': 'Flores', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006375']
1601,30239215,Psychometric Properties of Figure Rating Scales in Children: The Impact of Figure Ordering.,"This study examined psychometric properties of figure rating scales, particularly the effects of ascending silhouette ordering, in 153 children, 9 to 13 years old. Two versions of Collins's (1991) figural rating scale were presented: the original scale (figures arranged ascendingly) and a modified version (randomized figure ordering). Ratings of current and ideal figure were elicited and body dissatisfaction was calculated. All children were randomly assigned to one of two subgroups and completed both scale versions in a different sequence. There were no significant differences in figure selection and body dissatisfaction between the two figure orderings. Regarding the selection of the current figure, results showed that girls are more affected by the silhouette ordering than boys. Our results suggest that figure rating scales are both valid and reliable, whereby correlation coefficients reveal greater stability for ideal figure selections and body dissatisfaction ratings when using the scale with ascending figure ordering.",2020,There were no significant differences in figure selection and body dissatisfaction between the two figure orderings.,"['153 children, 9 to 13 years old', 'Children']",[],"['figure selection and body dissatisfaction', 'Psychometric Properties of Figure Rating Scales', ""Collins's (1991) figural rating scale""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0222045'}]",153.0,0.0180253,There were no significant differences in figure selection and body dissatisfaction between the two figure orderings.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Zitzmann', 'Affiliation': 'Department of Psychology, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Warschburger', 'Affiliation': 'Department of Psychology, University of Potsdam, Potsdam, Germany.'}]",Journal of personality assessment,['10.1080/00223891.2018.1505731']
1602,31314073,"Urine Tenofovir Concentrations Correlate With Plasma and Relate to Tenofovir Disoproxil Fumarate Adherence: A Randomized, Directly Observed Pharmacokinetic Trial (TARGET Study).","BACKGROUND


Direct measurement of tenofovir (TFV) in urine could be an objective measure to monitor adherence to preexposure prophylaxis (PrEP) or TFV-based antiretroviral therapy (ART).
METHODS


We conducted a 3-arm randomized, pharmacokinetic study of tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg among adults living with human immunodeficiency virus. Participants were randomized to receive controlled TDF/FTC dosing as (1) ""perfect"" adherence (daily); (2) ""moderate"" adherence (4 doses/week); or (3) ""low"" adherence (2 doses/week). We obtained trough spot urine and plasma samples during a 6-week directly observed therapy period and a 4-week washout period. TFV concentrations were compared between adherence arms using 1-way analysis of variance.
RESULTS


Among 28 participants, the median age was 33 years and 16 (57%) were male. Correlation between TFV plasma and urine concentrations was strong (ρ = 0.78; P < .0001). Median (interquartile range) steady-state trough TFV concentrations (ng/mL) for perfect, moderate, and low TDF adherence were 41 (26-52), 16 (14-19), and 4 (3-5) in plasma; and 6480 (3940-14 300), 3405 (2210-5020), and 448 (228-675) in urine. Trough TFV concentrations at steady state were significantly different between the 3 adherence arms for plasma (P < .0001) and urine (P = .0002). Following drug cessation, TFV concentrations persisted longer in urine than plasma samples. Washout urine TFV concentrations and time to undetectable concentrations did not differ between the 3 randomized adherence groups.
CONCLUSIONS


Urine TFV concentrations can inform interpretation of novel point-of-care urine-based TFV assays to assess recent TDF adherence.
CLINICAL TRIALS REGISTRATION


NCT0301260.",2020,Trough TFV concentrations at steady state were significantly different between the three adherence arms for plasma (p<0.0001) and urine (p=0.0002).,"['HIV-uninfected adults', '28 participants, mean age was 33 years and 16 (57%) were male', 'adults with controlled levels of adherence to advance development and enable interpretation of point-of-care urine assays']","['controlled TDF/FTC', 'tenofovir (TFV', 'tenofovir disoproxil fumarate (TDF) 300mg/emtricitabine (FTC']","['Washout urine TFV concentrations and time-to-undetectable concentrations', 'Median [IQR] steady-state trough TFV concentrations (ng/mL) for perfect, moderate, and low TDF adherence in plasma', 'TDF Adherence', 'urine TFV concentrations', 'Trough TFV concentrations', 'TFV plasma and urine concentrations', 'TFV concentrations']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0042037'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",28.0,0.15944,Trough TFV concentrations at steady state were significantly different between the three adherence arms for plasma (p<0.0001) and urine (p=0.0002).,"[{'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Suriyan', 'Initials': 'S', 'LastName': 'Tanasri', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Pimpinun', 'Initials': 'P', 'LastName': 'Punyati', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Wasna', 'Initials': 'W', 'LastName': 'Sirirungsi', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz645']
1603,31428854,Urinary markers of hydration during 3-day water restriction and graded rehydration.,"PURPOSE


This investigation had three purposes: (a) to evaluate changes in hydration biomarkers in response to a graded rehydration intervention (GRHI) following 3 days of water restriction (WR), (b) assess within-day variation in urine concentrations, and (c) quantify the volume of fluid needed to return to euhydration as demonstrated by change in U col .
METHODS


115 adult males and females were observed during 1 week of habitual fluid intake, 3 days of fluid restriction (1000 mL day -1 ), and a fourth day in which the sample was randomized into five different GRHI groups: no additional water, CON; additional 500 mL, G +0.50 ; additional 1000 mL, G +1.00 ; additional 1500 mL, G +1.50 ; additional 2250 mL, G +2.25 . All urine was collected on 1 day of the baseline week, during the final 2 days of the WR, and during the day of GRHI, and evaluated for urine osmolality, color, and specific gravity.
RESULTS


Following the GRHI, only G +1.50  and G +2.25  resulted in all urinary values being significantly different from CON. The mean volume of water increase was significantly greater for those whose U col  changed from > 4 to < 4 (+ 1435 ± 812 mL) than those whose U col  remained ≥ 4 (+ 667 ± 722 mL, p < 0.001).
CONCLUSIONS


An additional 500 mL of water is not sufficient, while approximately 1500 mL of additional water (for a total intake between 2990 and 3515 mL day -1 ) is required to return to a urine color associated with adequate water intake, following 3 days of WR.",2020,"RESULTS


Following the GRHI, only G +1.50  and G +2.25  resulted in all urinary values being significantly different from CON.",['115 adult males and females'],"['GRHI groups: no additional water, CON; additional 500\xa0mL, G +0.50 ; additional 1000\xa0mL, G +1.00 ; additional 1500\xa0mL, G +1.50 ; additional 2250\xa0mL, G +2.25 ']","['urine osmolality, color, and specific gravity', 'mean volume of water increase']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine (procedure)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0037786', 'cui_str': 'Relative Density'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",115.0,0.0719872,"RESULTS


Following the GRHI, only G +1.50  and G +2.25  resulted in all urinary values being significantly different from CON.","[{'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Johnson', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, 1000 E. University Ave, Laramie, WY, 82071, USA. evancjohnson@gmail.com.'}, {'ForeName': 'Ainsley E', 'Initials': 'AE', 'LastName': 'Huffman', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, 1000 E. University Ave, Laramie, WY, 82071, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Yoder', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, 1000 E. University Ave, Laramie, WY, 82071, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dolci', 'Affiliation': 'Danone Research, Palaiseau, France.'}, {'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Perrier', 'Affiliation': 'Danone Research, Palaiseau, France.'}, {'ForeName': 'D Enette', 'Initials': 'DE', 'LastName': 'Larson-Meyer', 'Affiliation': 'Department of Family and Consumer Sciences, University of Wyoming, Laramie, WY, USA.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Armstrong', 'Affiliation': 'Hydration & Nutrition, LLC, Newport News, VA, USA.'}]",European journal of nutrition,['10.1007/s00394-019-02065-7']
1604,32438543,Silicone Implant Versus Silicone Implant Assisted by Stromal Enriched Lipograft Breast Augmentation: A Prospective Comparative Study.,"Background:  Implant-assisted breast augmentation is among the most performed surgeries performed by plastic surgeons today. This prospective study evaluated the patient satisfaction and complication rates using high-profile round silicone implant alone (traditional breast augmentation) Group A versus the high-profile round silicone implant assisted with stromal enriched lipograft (composite breast augmentation) Group B.  Methods:  A total of 50 female patient candidates to undergo breast augmentation between January to September 2017 were randomly assigned to either group. The periareolar technique for breast augmentation and the subfascial plane were used in both groups for the insertion of the high-profile round silicone implants. The stromal enriched lipograft (SEL) was used in Group B for the preparation of the autologous fat grafting to the breast. The satisfaction of each patient with body appearance following breast augmentation was rated using an already published scale of 1-5. The rate of complications was analysed.  Results:  AS performed all the surgeries. In Group A, the age range was between 19 and 48 years (mean of 22.5 years). In Group B, the age range was between 20 and 47 years (mean of 24.1 years). The average BMI of Group A was 24 m/kg 2  and 23 m/kg 2  of Group B. Patient satisfaction meta-analysis for Group A and B at 12 months shows that patients in Group B expressed a satisfaction that is superior when compared to Group A patients. The ability to camouflage the implant could explain the higher satisfaction rates in Group B. The rate of complications appears similar in both groups.  Conclusions:  Composite breast augmentation using a combination of round high-profile implants and SEL in breast augmentation can achieve a higher patient satisfaction and aesthetic outcome as compared to the round high-profile breast augmentation alone. The technique is safe, simple and fast with low complication rates. Large multicentre, controlled, prospective studies need to be performed to further confirm the favourable results that were observed in this study.",2020,The rate of complications appears similar in both groups.  ,"['50 female patient candidates to undergo breast augmentation between January to September 2017', 'In Group A, the age range was between 19 and 48 years (mean of 22.5 years']","['Composite breast augmentation using a combination of round high-profile implants and SEL', 'high-profile round silicone implant assisted with stromal enriched lipograft (composite breast augmentation', 'high-profile round silicone implant alone (traditional breast augmentation', 'Silicone Implant Versus Silicone Implant Assisted by Stromal Enriched Lipograft Breast Augmentation', ':  Implant-assisted breast augmentation']","['patient satisfaction and complication rates', 'rate of complications', 'satisfaction rates', 'average BMI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517649', 'cui_str': '22.5'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0574702', 'cui_str': 'Selkup language'}, {'cui': 'C1289793', 'cui_str': 'Silicone implant'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0234892,The rate of complications appears similar in both groups.  ,"[{'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Sterodimas', 'Affiliation': 'Plastic & Reconstructive Surgery Department, Metropolitan General Hospital, 264 Mesogeion Avenue, 15562 Athens, Greece.'}]","Medicines (Basel, Switzerland)",['10.3390/medicines7050028']
1605,31422028,Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis.,"BACKGROUND


Phase 3 clinical data has shown higher proportions of patients with objective response, longer response duration, and longer overall survival with nivolumab versus docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival.
METHODS


We pooled data from four clinical studies of nivolumab in patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003) to evaluate survival outcomes. Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included. Comparisons of nivolumab versus docetaxel included all randomised patients from the phase 3 CheckMate 017 and 057 studies. We did landmark analyses by response status at 6 months to determine post-landmark survival outcomes. We excluded patients who did not have a radiographic tumour assessment at 6 months. Safety analyses included all patients who received at least one dose of nivolumab.
FINDINGS


Across all four studies, 4-year overall survival with nivolumab was 14% (95% CI 11-17) for all patients (n=664), 19% (15-24) for those with at least 1% PD-L1 expression, and 11% (7-16) for those with less than 1% PD-L1 expression. In CheckMate 017 and 057, 4-year overall survival was 14% (95% CI 11-18) in patients treated with nivolumab, compared with 5% (3-7) in patients treated with docetaxel. Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52 (0·37-0·71) for nivolumab and 0·80 (0·61-1·04) for docetaxel. Long-term data did not show any new safety signals.
INTERPRETATION


Patients with advanced NSCLC treated with nivolumab achieved a greater duration of response compared with patients treated with docetaxel, which was associated with a long-term survival advantage.
FUNDING


Bristol-Myers Squibb.",2019,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","['patients with previously treated advanced non-small-cell lung cancer (NSCLC', 'patients from the phase 3 CheckMate 017 and 057 studies', 'patients who did not have a radiographic tumour assessment at 6 months', 'patients with previously treated advanced non-small-cell lung cancer', 'patients who received at least one dose of nivolumab', 'patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003', 'Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included']","['docetaxel', 'nivolumab versus docetaxel', 'nivolumab or docetaxel', 'nivolumab']","['survival outcomes', 'duration of response', '4-year overall survival with nivolumab', '4-year overall survival', 'Survival subsequent to response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]",664.0,0.50406,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","[{'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. Electronic address: scott.antonia@duke.edu.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Castro Carpeño', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pluzanski', 'Affiliation': 'Klinika Nowotworow Pluca i Klatki Piersiowej, Centrum Onkologii-Instytut Im Marii Sklodowskiej-Curie, Warsaw, Poland.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Burgio', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garassino', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Crinò', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Institut Gustave Roussy, Department of Medical Oncology, Thoracic Group, Villejuif, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wojcik-Tomaszewska', 'Affiliation': 'Wojewodzkie Centrum Onkologii, Gdańsk, Poland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Otterson', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Penrod', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30407-3']
1606,32202231,Effects of nicotine on microvascular responsiveness after nicotine satiety versus overnight nicotine abstinence.,,2020,,[],['nicotine'],['microvascular responsiveness'],[],"[{'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",,0.0330574,,"[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruseghini', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Capelli', 'Affiliation': 'Department of Physical Performances, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Baraldo', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Chiamulera', 'Affiliation': 'Neuropsychopharmacology Lab, Department of Diagnostic and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zandonai', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behaviour Research Centre, Faculty of Psychology, University of Granada, Granada, Spain.'}]","Vascular medicine (London, England)",['10.1177/1358863X20906029']
1607,31424099,Culturally Competent Parenting: A Test of Web-Based Training for Transracial Foster and Adoptive Parents.,"This study tested a web-based parenting course called FosterParentCollege.com (FPC) Culturally Competent Parenting (CCP) for transracial foster and adoptive parents. Research indicates that transracial children, whose parents practice culturally competent parenting, have positive outcomes. A mixed methods pretest posttest treatment and control group design were implemented to determine if there was a difference in parent scores on openness to cultural receptivity after completing the course in comparison to parents assigned the control group. Cultural receptivity is defined as the effort that parents are willing to put forth to learn about CCP. Additionally, parents who participated in the treatment course completed 2-month follow-up interviews on self-reported application of techniques. Results of the study showed that parents enrolled in the treatment course had significantly higher scores for openness to cultural receptivity after completing the course than before. Themes identified in follow-up interviews indicated parents' efforts to learn more about CCP.",2020,Results of the study showed that parents enrolled in the treatment course had significantly higher scores for openness to cultural receptivity after completing the course than before.,['Transracial Foster and Adoptive Parents'],"['Culturally Competent Parenting', 'Culturally Competent Parenting (CCP', 'web-based parenting course called FosterParentCollege.com (FPC']",['cultural receptivity'],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0337466', 'cui_str': 'Adoptive parent (person)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",[],,0.0176702,Results of the study showed that parents enrolled in the treatment course had significantly higher scores for openness to cultural receptivity after completing the course than before.,"[{'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Montgomery', 'Affiliation': 'Florida State University.'}]",Journal of marital and family therapy,['10.1111/jmft.12401']
1608,30714880,Randomized pilot trial of Web-based cognitive-behavioral therapy adapted for use in office-based buprenorphine maintenance.,"Background : Despite the clear success of office-based buprenorphine treatment in increasing availability of effective treatment for opioid use disorder, constraints on its effectiveness include high attrition and limited high-quality behavioral care in many areas. Web-based interventions may be a novel strategy for providing evidence-based behavioral care to individuals receiving office-based buprenorphine maintenance. This report describes modification and initial pilot testing of Web-based training in cognitive-behavioral therapy (CBT4CBT) specifically for use with individuals in office-based buprenorphine.  Methods : Twelve-week randomized pilot trial evaluating effects of CBT4CBT-Buprenophine in retaining participants and reducing drug use with respect to standard office-based buprenorphine alone was carried out. Twenty individuals meeting DSM-5 ( Diagnostic and Statistical Manual of Mental Disorders, 5th Edition ) criteria for current opioid use disorder were randomized to standard buprenorphine treatment or buprenorphine plus access to CBT4CBT-Buprenorphine.  Results : There were promising findings regarding rates of urine toxicology screens negative for opioids (91% versus 64%;  P  = .05, effect size  d  = 0.88) and all drugs (82% versus 30%;  P  = .004,  d =  1.2). Individuals randomized to CBT4CBT-Buprenorphine completed a mean of 82.6 (SD = 4.4) days of treatment (of a possible 84) compared with 68.6 (SD = 32.6) for those assigned to standard buprenorphine treatment.  Conclusions : Although preliminary and limited by the small sample size, this trial suggests the feasibility and promise of validated, Web-based interventions, tailored for this specific patient population, for improving outcomes in office-based buprenorphine.",2019,"There were promising findings regarding rates of urine toxicology screens negative for opioids (91% versus 64%; P = .05, effect size d = 0.88) and all drugs (82% versus 30%; P = .004, d = 1.2).","['individuals in office-based buprenorphine', 'Twenty individuals meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria for current opioid use disorder', 'retaining participants and reducing drug use with respect to standard office-based']","['CBT4CBT-Buprenophine', 'buprenorphine maintenance', 'buprenorphine treatment or buprenorphine plus access to CBT4CBT-Buprenorphine', 'buprenorphine', 'Web-based training in cognitive-behavioral therapy (CBT4CBT', 'Web-based cognitive-behavioral therapy', 'CBT4CBT-Buprenorphine']",['rates of urine toxicology screens negative for opioids'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0042037'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",20.0,0.0658385,"There were promising findings regarding rates of urine toxicology screens negative for opioids (91% versus 64%; P = .05, effect size d = 0.88) and all drugs (82% versus 30%; P = .004, d = 1.2).","[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Shi', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine , New Haven , Connecticut , USA.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Henry', 'Affiliation': 'Central Medical Unit, The APT Foundation , New Haven , Connecticut , USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dwy', 'Affiliation': 'Central Medical Unit, The APT Foundation , New Haven , Connecticut , USA.'}, {'ForeName': 'Skye A', 'Initials': 'SA', 'LastName': 'Orazietti', 'Affiliation': 'Central Medical Unit, The APT Foundation , New Haven , Connecticut , USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine , New Haven , Connecticut , USA.'}]",Substance abuse,['10.1080/08897077.2019.1569192']
1609,31944804,"Use of common and unique techniques in the early treatment phase for cognitive-behavioral, interpersonal/emotional, and supportive listening interventions for generalized anxiety disorder.","Psychotherapy research often compares specific treatments to control conditions to establish efficacy of the specified treatment. Research has typically evaluated common factor elements (e.g., credibility, expectancy) in treatments only after the first or second session, largely as a manipulation check and under the assumption that such factors are static. This study observed therapist common factor and model-specific interventions in three treatment approaches from a randomized control trial for generalized anxiety disorder across the entire early phase of treatment (i.e., first five sessions). The parent randomized control trial compared two treatment conditions, using an additive design where patients were randomized to receive either interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy. The first five video-recorded sessions of  N  = 40 randomly sampled participants were observationally coded with a multidimensional intervention measure, with subscales reflecting diverse theoretical orientations and common factors. Multilevel modeling was used to examine intervention use and investigate differences between treatment conditions and segments. Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening. The pattern of intervention use of other subscales was generally consistent with the orientation of the respective protocols. In the early phase of treatment, supportive listening conditions do not appear to function as common factor controls in the manner that many might assume. Common factors are potentially enhanced in bona fide treatments that include a more detailed, specific rationale and clear and cohesive techniques and goals. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.",['generalized anxiety disorder'],"['therapist common factor and model-specific interventions', 'interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy']",[],"[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],2020.0,0.0256031,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.","[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Schwartzman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kyler', 'Initials': 'K', 'LastName': 'Lehrbach', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Louis G', 'Initials': 'LG', 'LastName': 'Castonguay', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000277']
1610,7080769,"[Evaluation of the safety, reactogenicity and antigenic activity of inactivated chromatographic influenza vaccine in school children].","To evaluate the safety, reactogenicity and immunogenicity of inactivated chromatographic influenza vaccine A(H3N2) produced by the Pasteur Research Institute of Epidemiology and Microbiology in Leningrad, children aged 7-15 years received the vaccine intradermally in doses of 114-228 IU, and 152 children received placebo. In this study inactivated influenza vaccine introduced parenterally to children aged 11-15 years in a dose of 228 IU proved to be nonreactogenic. The reactogenicity index of the preparation injected in a dose of 114 IU to children aged 7-10 years was 0.6%. Immunization in a single injection was accompanied by significant seroconversions in 87.5%-96.0% of children with the highly pronounced growth of antibody titers (21.1-34.6 times). The complex of clinico-laboratory tests showed the safety of this preparation for both age groups.",1982,Immunization in a single injection was accompanied by significant seroconversions in 87.5%-96.0% of children with the highly pronounced growth of antibody titers (21.1-34.6 times).,"['school children', 'children aged 11-15 years in a dose of 228 IU proved to be nonreactogenic', 'Leningrad, children aged 7-15 years received the vaccine intradermally in doses of 114-228 IU, and 152 children received']","['inactivated chromatographic influenza vaccine A(H3N2', 'inactivated chromatographic influenza vaccine', 'placebo', 'influenza vaccine']","['safety, reactogenicity and immunogenicity', 'safety, reactogenicity and antigenic activity', 'antibody titers', 'reactogenicity index']","[{'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0592386,Immunization in a single injection was accompanied by significant seroconversions in 87.5%-96.0% of children with the highly pronounced growth of antibody titers (21.1-34.6 times).,"[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': ""Vasil'eva"", 'Affiliation': ''}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Osidak', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bichurina', 'Affiliation': ''}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Mukhina', 'Affiliation': ''}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Chudina', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1611,32199152,"Interplay between PCI access site, anticoagulant agent, and bleeding: Insights from the REGULATE-PCI randomized trial.",,2020,,[],[],[],[],[],[],,0.0367254,,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Marquis-Gravel', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Zelenkofske', 'Affiliation': 'Regado Biosciences, Basking Ridge, NJ, USA.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, OH, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY, USA.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université Paris-Diderot, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA. Electronic address: thomas.povsic@duke.edu.'}]",American heart journal,['10.1016/j.ahj.2020.02.013']
1612,8067145,[The determination of the optimal inoculation dose of an oral cholera bivalent chemical vaccine in a controlled trial of the vaccination of children and adolescents].,"The reactogenicity and immunological effectiveness of different doses of cholera vaccine for oral administration (in tablets), containing choleragen toxoid, Ogawa and Inaba O-antigens and some of Vibrio cholerae exoenzymes, have been tested on 143 children aged 2-17 years. In this investigation the optimum immunization doses of the preparation have been established: two tablets containing 100,000 binding units (BU) of the toxoid and 2,500 units of O-antigen for children 11-14 years; four tablets containing 200,000 BU of the toxoid and 5,000 units of O-antigen for adolescents aged 15-17 years. An essential advantage of the oral vaccine over vaccines intended for parenteral administration lies in its capacity for inducing the accumulation of secretory antibodies (coproantibodies) in practically all vaccinees.",1993,"The reactogenicity and immunological effectiveness of different doses of cholera vaccine for oral administration (in tablets), containing choleragen toxoid, Ogawa and Inaba O-antigens and some of Vibrio cholerae exoenzymes, have been tested on 143 children aged 2-17 years.","['children and adolescents', 'adolescents aged 15-17 years', '143 children aged 2-17 years']","['cholera vaccine', 'oral cholera bivalent chemical vaccine']",['reactogenicity and immunological effectiveness'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}]","[{'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008354', 'cui_str': 'Vibrio cholerae Infection'}, {'cui': 'C0026384', 'cui_str': 'Molecular Vaccines'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",143.0,0.105902,"The reactogenicity and immunological effectiveness of different doses of cholera vaccine for oral administration (in tablets), containing choleragen toxoid, Ogawa and Inaba O-antigens and some of Vibrio cholerae exoenzymes, have been tested on 143 children aged 2-17 years.","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Sumarokov', 'Affiliation': ''}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Dzhaparidze', 'Affiliation': ''}, {'ForeName': 'Iu Iu', 'Initials': 'IuIu', 'LastName': 'Eliseev', 'Affiliation': ''}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Nikitina', 'Affiliation': ''}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Poliakov', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Kazakova', 'Affiliation': ''}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Meleshchenko', 'Affiliation': ''}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Tsareva', 'Affiliation': ''}, {'ForeName': 'Iu B', 'Initials': 'IuB', 'LastName': 'Reznikov', 'Affiliation': ''}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Adamova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1613,32141678,Patient-reported swallowing function after treatment for early-stage oropharyngeal carcinoma: Population-based study.,"BACKGROUND


Single-modality treatment (surgery or radiotherapy [RT]) is a curative treatment option for early-stage oropharyngeal carcinoma (OPC) with comparable (excellent) oncological outcomes. This study aimed to compare self-reported swallowing function.
METHODS


Participants with a T1-2N0-2bM0 OPC who were offered single-modality treatment and were recruited to the Head and Neck 5000 study were included. Prospectively collected self-reported swallowing function was compared between surgery and RT.
RESULTS


Those offered RT (n = 150) had less favorable baseline characteristics than those offered surgery (n = 150). At 12-month follow up, RT participants reported more swallowing problems (35% vs 23%, RR 1.3; 95% CI 0.8-2.3, P = .277) in models adjusted for baseline characteristics. In those allocated to surgery who received adjuvant therapy (n = 78, 52%), the proportion with swallowing problems was similar to those allocated to RT alone.
CONCLUSIONS


Participants offered surgery alone had similar mortality but improved swallowing, although this was not statistically significant. However, over half of participants offered surgery alone received surgery and adjuvant therapy.",2020,"At 12-month follow up, RT participants reported more swallowing problems (35% vs 23%, RR 1.3; 95% CI 0.8-2.3, P = .277) in models adjusted for baseline characteristics.","['Participants with a T1-2N0-2bM0 OPC who were offered single-modality treatment and were recruited to the Head and Neck 5000 study were included', 'early-stage oropharyngeal carcinoma (OPC']","['adjuvant therapy', 'Single-modality treatment (surgery or radiotherapy [RT']","['swallowing function', 'swallowing problems', 'proportion with swallowing problems']","[{'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392678', 'cui_str': 'Swallowing problem (finding)'}]",5000.0,0.121253,"At 12-month follow up, RT participants reported more swallowing problems (35% vs 23%, RR 1.3; 95% CI 0.8-2.3, P = .277) in models adjusted for baseline characteristics.","[{'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Karsten', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel W M', 'Initials': 'MWM', 'LastName': 'van den Brekel', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Ludi E', 'Initials': 'LE', 'LastName': 'Smeele', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Leary', 'Affiliation': 'Bristol Biomedical Research Centre, National Institute of Health (NIHR), University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ingarfield', 'Affiliation': 'Bristol Biomedical Research Centre, National Institute of Health (NIHR), University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pawlita', 'Affiliation': 'Infections and Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Waterboer', 'Affiliation': 'Infections and Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Steve J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Bristol Biomedical Research Centre, National Institute of Health (NIHR), University of Bristol, Bristol, UK.'}, {'ForeName': 'Andy R', 'Initials': 'AR', 'LastName': 'Ness', 'Affiliation': 'Bristol Biomedical Research Centre, National Institute of Health (NIHR), University of Bristol, Bristol, UK.'}]",Head & neck,['10.1002/hed.26131']
1614,32141721,The Trend of Increasing Placebo Response and Decreasing Treatment Effect in Schizophrenia Trials Continues: An Update From the US Food and Drug Administration.,"OBJECTIVE


Concerns of increasing placebo response and declining treatment effect in acute schizophrenia trials have been reported for new drug applications (NDAs) submitted to the US Food and Drug Administration (FDA) during an 18-year period from 1991 through January 2009 (ie, the pre-2009 period). Current exploratory analyses provide an update in the trends observed in placebo response, treatment effect, and dropout rates for NDAs submitted from February 2009 to 2015 (ie, the post-2009 period).
DATA SOURCES


Clinical trial data from all acute schizophrenia trials that were submitted as part of NDAs to the US FDA during a 24-year period from 1991 to 2015.
STUDY SELECTION


Aggregate trial-level efficacy data from multicenter, multiregional, randomized, placebo-controlled, 4- to 8-week, fixed- and flexible-dose trials in adult schizophrenia patients were compiled. There were 12 NDAs pre-2009 (32 trials, N = 11,567) and 3 NDAs post-2009 (14 trials, N = 6,434).
DATA EXTRACTION


Baseline demographic and disease variables and scores on the Positive and Negative Syndrome Scale (PANSS) were summarized and compared for the two time periods (pre-2009 and post-2009). The primary efficacy measure was mean change from baseline to endpoint in total PANSS score obtained by last-observation-carried-forward analysis. Regional differences in placebo response and treatment effect were explored for the two time periods based on baseline patient characteristics, sample size, and dropout rates.
RESULTS


Trials were predominantly multiregional (10/14; 71%) during the post-2009 period compared to the pre-2009 period (11/32; 34%). The overall trial success rates were 57% (8/14) and 78% (25/32) during the post-2009 and pre-2009 periods, respectively. Comparing the pre-2009 and post-2009 periods, the mean placebo response (change from baseline in PANSS score) increased from -6.4 to -10.5 and the mean treatment effect (drug response - placebo response) declined from -8.6 to -5.8 , with substantial differences observed especially in North American trials. In North American trials, placebo response increased from -4.3 (pre-2009) to -8.5 (post-2009), and treatment effect decreased from -9.0 (pre-2009) to -3.4 (post-2009). The difference in placebo response (pre- and post-2009: -10.0 and -11.3 ) and treatment effect (pre and post-2009: -8.1 and -6.4 ) in multiregional trials for the two time periods remained minimal. Baseline disease severity remained similar in the pre- and post-2009 time periods, with PANSS scores ranging between 85 and 100. Trials with higher mean baseline PANSS scores tended to show higher treatment effect irrespective of the time period and region. Post-2009, dropout rates were higher (55%) in North American trials compared with 33% in multiregional trials, similar to the pre-2009 trend.
CONCLUSIONS


The continuing trend of increasing placebo responses and decreasing treatment effects in schizophrenia trials over the 24-year period does remain of great concern, especially with respect to North American trials. However, given the current global nature of drug development, close attention to trial conduct and reexamination of design elements for future trials may be warranted.",2020,"Regional differences in placebo response and treatment effect were explored for the two time periods based on baseline patient characteristics, sample size, and dropout rates.
","['Schizophrenia Trials Continues', 'adult schizophrenia patients']",['placebo'],"['Baseline demographic and disease variables and scores on the Positive and Negative Syndrome Scale (PANSS', 'dropout rates', 'Baseline disease severity', 'total PANSS score', 'placebo response', 'mean placebo response', 'overall trial success rates']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",11567.0,0.465673,"Regional differences in placebo response and treatment effect were explored for the two time periods based on baseline patient characteristics, sample size, and dropout rates.
","[{'ForeName': 'Mathangi', 'Initials': 'M', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Center for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, MD. mgopalakrishnan@rx.umaryland.edu.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Tiffany R', 'Initials': 'TR', 'LastName': 'Farchione', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Mathis', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Uppoor', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Younis', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19r12960']
1615,32496074,"Effects of the COVID-19 pandemic and nationwide lockdown on trust, attitudes toward government, and well-being.","The contagiousness and deadliness of COVID-19 have necessitated drastic social management to halt transmission. The immediate effects of a nationwide lockdown were investigated by comparing matched samples of New Zealanders assessed before (N prelockdown  = 1,003) and during the first 18 days of lockdown (N lockdown  = 1,003). Two categories of outcomes were examined: (a) institutional trust and attitudes toward the nation and government and (b) health and well-being. Applying propensity score matching to approximate the conditions of a randomized controlled experiment, the study found that people in the pandemic/lockdown group reported higher trust in science, politicians, and police, higher levels of patriotism, and higher rates of mental distress compared to people in the prelockdown prepandemic group. Results were confirmed in within-subjects analyses. The study highlights social connectedness, resilience, and vulnerability in the face of adversity and has applied implications for how countries face this global challenge. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Two categories of outcomes were examined: (a) institutional trust and attitudes toward the nation and government and (b) health and well-being.,[],"['COVID-19 pandemic and nationwide lockdown', 'nationwide lockdown']","['institutional trust and attitudes toward the nation and government and (b) health and well-being', 'mental distress']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0235109', 'cui_str': 'Mental distress'}]",,0.0275454,Two categories of outcomes were examined: (a) institutional trust and attitudes toward the nation and government and (b) health and well-being.,"[{'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Sibley', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Lara M', 'Initials': 'LM', 'LastName': 'Greaves', 'Affiliation': 'School of Social Sciences, University of Auckland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Satherley', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Wilson', 'Affiliation': 'School of Psychology, Victoria University of Wellington.'}, {'ForeName': 'Nickola C', 'Initials': 'NC', 'LastName': 'Overall', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Carol H J', 'Initials': 'CHJ', 'LastName': 'Lee', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Milojev', 'Affiliation': 'School of Humanities, University of Auckland.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bulbulia', 'Affiliation': 'School of Humanities, University of Auckland.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Osborne', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Taciano L', 'Initials': 'TL', 'LastName': 'Milfont', 'Affiliation': 'School of Psychology, Victoria University of Wellington.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Houkamau', 'Affiliation': 'Department of Management and International Business, University of Auckland.'}, {'ForeName': 'Isabelle M', 'Initials': 'IM', 'LastName': 'Duck', 'Affiliation': 'Silverdale Medical.'}, {'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Vickers-Jones', 'Affiliation': 'School of Psychology, University of Queensland.'}, {'ForeName': 'Fiona Kate', 'Initials': 'FK', 'LastName': 'Barlow', 'Affiliation': 'School of Psychology, University of Queensland.'}]",The American psychologist,['10.1037/amp0000662']
1616,32138809,Surgical interventions for uterine prolapse and for vault prolapse: the two VUE RCTs.,"BACKGROUND


New surgical approaches for apical prolapse have gradually been introduced, with few prospective randomised controlled trial data to evaluate their safety and efficacy compared with traditional methods.
OBJECTIVE


To compare surgical uterine preservation with vaginal hysterectomy in women with uterine prolapse and abdominal procedures with vaginal procedures in women with vault prolapse in terms of clinical effectiveness, adverse events, quality of life and cost-effectiveness.
DESIGN


Two parallel randomised controlled trials (i.e. Uterine and Vault). Allocation was by remote web-based randomisation (1 : 1 ratio), minimised on the need for concomitant anterior and/or posterior procedure, concomitant incontinence procedure, age and surgeon.
SETTING


UK hospitals.
PARTICIPANTS


Uterine trial - 563 out of 565 randomised women had uterine prolapse surgery. Vault trial - 208 out of 209 randomised women had vault prolapse surgery.
INTERVENTIONS


Uterine trial - uterine preservation or vaginal hysterectomy. Vault trial - abdominal or vaginal vault suspension.
MAIN OUTCOME MEASURES


The primary outcome measures were women's prolapse symptoms (as measured using the Pelvic Organ Prolapse Symptom Score), prolapse-specific quality of life and cost-effectiveness (as assessed by incremental cost per quality-adjusted life-year).
RESULTS


Uterine trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for uterine preservation was 4.2 (standard deviation 4.9) versus vaginal hysterectomy with a Pelvic Organ Prolapse Symptom Score of 4.2 (standard deviation 5.3) (mean difference -0.05, 95% confidence interval -0.91 to 0.81). Serious adverse event rates were similar between the groups (uterine preservation 5.4% vs. vaginal hysterectomy 5.9%; risk ratio 0.82, 95% confidence interval 0.38 to 1.75). There was no difference in overall prolapse stage. Significantly more women would recommend vaginal hysterectomy to a friend (odds ratio 0.39, 95% confidence interval 0.18 to 0.83). Uterine preservation was £235 (95% confidence interval £6 to £464) more expensive than vaginal hysterectomy and generated non-significantly fewer quality-adjusted life-years (mean difference -0.004, 95% confidence interval -0.026 to 0.019). Vault trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for an abdominal procedure was 5.6 (standard deviation 5.4) versus vaginal procedure with a Pelvic Organ Prolapse Symptom Score of 5.9 (standard deviation 5.4) (mean difference -0.61, 95% confidence interval -2.08 to 0.86). The serious adverse event rates were similar between the groups (abdominal 5.9% vs. vaginal 6.0%; risk ratio 0.97, 95% confidence interval 0.27 to 3.44). The objective anterior prolapse stage 2b or more was higher in the vaginal group than in the abdominal group (odds ratio 0.38, 95% confidence interval 0.18 to 0.79). There was no difference in the overall prolapse stage. An abdominal procedure was £570 (95% confidence interval £459 to £682) more expensive than a vaginal procedure and generated non-significantly more quality-adjusted life-years (mean difference 0.004, 95% confidence interval -0.031 to 0.041).
CONCLUSIONS


Uterine trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between uterine preservation and vaginal hysterectomy. Vault trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between an abdominal and a vaginal approach.
FUTURE WORK


Long-term follow-up for at least 6 years is ongoing to identify recurrence rates, need for further prolapse surgery, adverse events and cost-effectiveness.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN86784244.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 13. See the National Institute for Health Research Journals Library website for further project information.",2020,Uterine preservation was £235,"['UK hospitals', 'uterine prolapse and for vault prolapse', '209 randomised women had vault prolapse surgery', 'Uterine trial - 563 out of 565 randomised women had uterine prolapse surgery', 'women with uterine prolapse and abdominal procedures with vaginal procedures in women with vault prolapse']","['Surgical interventions', 'vaginal hysterectomy']","['overall prolapse stage', 'efficacy, quality of life or adverse events', ""women's prolapse symptoms (as measured using the Pelvic Organ Prolapse Symptom Score), prolapse-specific quality of life and cost-effectiveness (as assessed by incremental cost per quality-adjusted life-year"", 'Pelvic Organ Prolapse Symptom Score', 'mean Pelvic Organ Prolapse Symptom Score', 'clinical effectiveness, adverse events, quality of life and cost-effectiveness', 'objective anterior prolapse stage', 'Serious adverse event rates', 'vaginal hysterectomy', 'quality-adjusted life-years', 'safety and efficacy', 'serious adverse event rates']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0042140', 'cui_str': 'Uterine Prolapse'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0020700', 'cui_str': 'Colpohysterectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0020700', 'cui_str': 'Colpohysterectomy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",565.0,0.435082,Uterine preservation was £235,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Constable', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Dwayne', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professionals Research Unit (NMAHP RU), Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""St Mary's Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Derriford Hospital, Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Nursing, Midwifery and Allied Health Professionals Research Unit (NMAHP RU), Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Montgomery', 'Affiliation': 'Independent patient representative, c/o Health Services Research Unit, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, Edinburgh BioQuarter, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24130']
1617,32069472,Efficacy of Magnesium Sulfate Treatment in Children with Acute Asthma.,"OBJECTIVE


Systemic administration of magnesium sulfate (MgSO4) has been proposed as a treatment for pediatric patients with acute asthma. However, previous trials show mixed results and uncertain evidence of benefit. The aim of the study was to ascertain whether intravenous (IV) MgSO4 improves lung function parameters in children with acute asthma.
METHODS


This was a prospective clinical trial. All patients with acute asthma received 40-50 mg/kg or maximum 1,500 mg (>30 kg) of single dose IV MgSO4, administered over 60 min. Spirometry was conducted before and 15 min after MgSO4 infusion.
RESULTS


One hundred and fifteen children aged 6 to 17 years presenting with acute asthma and FEV1 between 40% and 75% of predicted were included. Then, the patients were classified into 2 groups; mild asthma attack (FEV1 ranged from 60% to 75%; n = 50) or moderate asthma attack (FEV1 ranged from 40% to 59%; n = 65). The baseline characteristics were similar in both groups. The mean percent predicted pre and post values for FEV1/FVC ratio (mild group: 82.59 ± 9.46 vs. 85.06 ± 8.95; moderate group: 77.31 ± 11.17 vs. 79.99 ± 11.77), FEV1 (mild group: 67.14 ± 4.99 vs. 72.29 ± 8.05; moderate group: 48.50 ± 6.81 vs. 53.78 ± 9.81), PEF (mild group: 65.49 ± 12.32 vs. 71.37 ± 12.96; moderate group: 47.56 ± 11.78 vs. 51.97 ± 13.98), and FEF25-75 (mild group: 58.20 ± 12.24 vs. 66.57 ± 16.95; moderate group: 37.77 ± 11.37 vs. 43.41 ± 14.19) showed a statistically significant (p < 0.05 for all) bronchodilator effect after MgSO4 infusion in both groups with few side effects.
CONCLUSION


Administration of IV MgSO4 was associated with improved pulmonary function in children with acute asthma.",2020,"The mean percent predicted pre and post values for FEV1/FVC ratio (mild group:82,59± 9,46 vs 85,06± 8,95; moderate group:77,31± 11,17 vs 79,99± 11,77),","['children with acute asthma', 'fifteen children aged 6 to 17 years presenting with acute asthma and FEV1 between 40% to 75% of predicted were included', 'patients were classified into 2 groups; mild asthma attack (FEV1 ranged 60% to 75%; n=50) or moderate asthma attack (FEV1 ranged 40% to 59%; n=65', 'All patients with acute asthma', 'One hundred', 'pediatric patients with acute asthma']","['IV MgSO4', 'SULPHATE', 'intravenous (IV) MgSO4', 'magnesium sulphate (MgSO4']","['pulmonary function', 'lung function measurements']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",115.0,0.416135,"The mean percent predicted pre and post values for FEV1/FVC ratio (mild group:82,59± 9,46 vs 85,06± 8,95; moderate group:77,31± 11,17 vs 79,99± 11,77),","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Özdemir', 'Affiliation': 'Pediatric Pulmonary Section, Department of Pediatrics, Mersin City Training and Research Hospital, Mersin, Turkey, aliozdemir@hotmail.com.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Doğruel', 'Affiliation': 'Pediatric Allergy Section, Department of Pediatrics, University of Cukurova, Adana, Turkey.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000506595']
1618,6805176,"[Bactericidal antibodies to meningococcal serogroups A, B and C in persons inoculated with a polycomponent meningococcal vaccine].","Three groups consisting of 56, 55 and 57 subjects were immunized with polycomponent meningococcal vaccine incorporating microbial cell-wall substance in the polymeric form. The vaccine was introduced in doses of 0.25 ml, 0.5 ml and 1.0 ml, respectively, which corresponded to 100 microns, 200 microns and 400 microns of the dry substance of the vaccine. Each of 53 subjects in the control group received placebo (physiological saline) in a dose of 0.5 ml. Serum specimens were taken from all vaccinees prior to injection and on days 21-24. After the injection of the vaccine in a dose of 0.25 ml the arithmetical mean of the antimeningococcal titers increased approximately 70-fold to serogroup A, 20-fold to serogroup B and 120-fold to serogroup C, and after the injection of the vaccine in doses of 0.5 ml and 1.0 ml the titers increased 225-fold, 80-fold and 480-fold, respectively. The fact of the formation of bactericidal antibodies to serogroup B meningococci is particularly noteworthy.",1982,"Three groups consisting of 56, 55 and 57 subjects were immunized with polycomponent meningococcal vaccine incorporating microbial cell-wall substance in the polymeric form.",[],"['placebo (physiological saline', 'polycomponent meningococcal vaccine']",['antimeningococcal titers'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine (product)'}]","[{'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.147287,"Three groups consisting of 56, 55 and 57 subjects were immunized with polycomponent meningococcal vaccine incorporating microbial cell-wall substance in the polymeric form.","[{'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Belova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
1619,32141723,"Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study.","OBJECTIVE


To assess the antipsychotic efficacy and safety of a combination of olanzapine and samidorphan (OLZ/SAM).
METHODS


This 4-week, phase 3, randomized, double-blind, placebo- and olanzapine-controlled study was conducted from December 2015 to June 2017 in adults with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who were experiencing an acute exacerbation. Patients were randomized 1:1:1 to OLZ/SAM, olanzapine monotherapy, or placebo. The primary and key secondary efficacy endpoint assessed was the change in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness Scale (CGI-S) score between baseline and week 4, respectively, for OLZ/SAM versus placebo. Safety monitoring occurred throughout.
RESULTS


401 patients received ≥ 1 dose of study drug; 352 completed treatment. Treatment with OLZ/SAM resulted in significant improvements versus placebo in PANSS total and CGI-S scores from baseline to week 4 (least squares [LS] mean ± SE: -6.4 ± 1.8 [P < .001] and -0.38 ± 0.12 [P = .002], respectively). Olanzapine treatment resulted in similar improvements (PANSS and CGI-S LS mean ± SE of -5.3 ± 1.84 [P = .004] and -0.44 ± 0.12 [P < .001], respectively). Adverse events (AEs) occurred in 54.5%, 54.9%, and 44.8% of patients on OLZ/SAM, olanzapine, and placebo, respectively. Weight gain, somnolence, dry mouth, anxiety, and headache were the most common AEs (ie, ≥ 5%) with active treatment.
CONCLUSIONS


OLZ/SAM treatment resulted in statistically and clinically significant efficacy improvements over 4 weeks versus placebo in adults with acutely exacerbated schizophrenia. Improvements were similar to those observed with olanzapine. OLZ/SAM was well tolerated, with a safety profile similar to that of olanzapine.
TRIAL REGISTRATIONS


ClinicalTrials.gov identifier: NCT02634346; EudraCT number: 2015-003373-15​​.",2020,"Treatment with OLZ/SAM resulted in significant improvements versus placebo in PANSS total and CGI-S scores from baseline to week 4 (least squares [LS] mean ± SE: -6.4 ± 1.8 [P < .001] and -0.38 ± 0.12 [P = .002], respectively).","['401 patients received ≥ 1 dose of study drug; 352 completed treatment', 'Adult Patients With an Acute Exacerbation of Schizophrenia', 'December 2015 to June 2017 in adults with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who were experiencing an acute exacerbation', 'adults with acutely exacerbated schizophrenia']","['OLZ/SAM, olanzapine monotherapy, or placebo', 'placebo', 'Olanzapine', 'olanzapine', 'OLZ/SAM', 'olanzapine and samidorphan (OLZ/SAM', 'Olanzapine and Samidorphan']","['PANSS total and CGI-S scores', 'antipsychotic efficacy and safety', 'Weight gain, somnolence, dry mouth, anxiety, and headache', 'Adverse events (AEs', 'Safety monitoring', 'change in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness Scale (CGI-S) score', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444749', 'cui_str': 'Exacerbated (qualifier value)'}]","[{'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0222045'}]",,0.293013,"Treatment with OLZ/SAM resulted in significant improvements versus placebo in PANSS total and CGI-S scores from baseline to week 4 (least squares [LS] mean ± SE: -6.4 ± 1.8 [P < .001] and -0.38 ± 0.12 [P = .002], respectively).","[{'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Potkin', 'Affiliation': 'School of Medicine, University of California, Irvine, California, USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Kunovac', 'Affiliation': 'Altea Research, Las Vegas, Nevada, USA.'}, {'ForeName': 'Bernard L', 'Initials': 'BL', 'LastName': 'Silverman', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'DiPetrillo', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDonnell', 'Affiliation': 'Alkermes Pharma Ireland Limited, Connaught House, 1 Burlington Rd, Dublin D04 C5Y6, Ireland. david.mcdonnell@alkermes.com.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12769']
1620,32141724,Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training.,"BACKGROUND


Developmental stages characterized by greater neural plasticity might be critical periods during which the effects of cognitive training (CT) could theoretically be maximized. However, experiencing a first episode of schizophrenia during childhood or adolescence (ie, early-onset schizophrenia [EOS]) may reduce the brain's ability to benefit from CT. This study examined the effects of EOS versus onset at > 18 years of age (ie, adult-onset schizophrenia [AOS]) as a predictor of response to CT and the relationship between duration of illness and cognitive improvements.
METHODS


This study is a secondary analysis of data from 2 randomized trials that examined the cognitive effects of neuroscience-informed auditory training (AT) exercises in 84 outpatients with schizophrenia (26 EOS, 58 AOS, recruited between 2004 and 2014).
RESULTS


There was a significant effect of time in all cognitive domains (F > 10.22, P < .002). The effect of EOS was significant only for verbal learning and memory (F = 5.79, P = .018). AOS increased the mean change score by 5.70 points in this domain, whereas EOS showed no change (t = -2.280, P = .025). However, the difference between AOS and EOS was no longer statistically significant after control for multiple comparisons. Shorter duration of illness was associated with greater improvement in problem solving in the AOS group (r = -0.27, P = .040).
CONCLUSIONS


Auditory training is effective in improving cognition in both EOS and AOS. Treatment effects in all cognitive domains were similar, with the exception of verbal learning and memory. This result requires replication. Cognitive training provided earlier in the course of the illness results in greater improvements in executive functions.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT00312962, NCT00694889​​.",2020,"There was a significant effect of time in all cognitive domains (F > 10.22, P < .002).","['84 outpatients with schizophrenia (26 EOS, 58 AOS, recruited between 2004 and 2014', 'versus onset at > 18 years of age (ie, adult-onset schizophrenia [AOS']","['Cognitive training', 'Auditory training', 'neuroscience-informed auditory training (AT) exercises', 'EOS', 'cognitive training (CT', 'Early']","['time in all cognitive domains', 'verbal learning and memory', 'Shorter duration of illness', 'problem solving', 'mean change score', 'AOS and EOS']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",84.0,0.0583286,"There was a significant effect of time in all cognitive domains (F > 10.22, P < .002).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Puig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Hospital Clínic Barcelona, Villarroel 170, 08036-Spain. opuig@clinic.ub.es.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Miley', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Ramsay', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Ragland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Niendam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12369']
1621,31983031,Rapid changes in neuroendocrine regulation may contribute to reversal of type 2 diabetes after gastric bypass surgery.,"OBJECTIVE


To explore the role of hormones and the autonomic nervous system in the rapid remission of diabetes after Roux-en-Y Gastric Bypass (RYGB).
RESEARCH DESIGN AND METHODS


Nineteen obese patients with type 2 diabetes, 7 M/12 F, were randomized (2:1) to RYGB or standard-of-care medical treatment (control). At baseline and 4 and 24 weeks post surgery, fasting blood sampling, OGTT, intravenous arginine challenge, and heart-rate variability (HRV) assessments were performed.
RESULTS


At both 4 and 24 weeks post-RYGB the following effects were found: arginine-stimulated insulin secretion was reduced. GLP-1, GIP, and glucagon rise during OGTT was enhanced. IGF-1 and GH levels increased. In addition, total HRV and spectral components P LF  (power of low frequency) and P HF  (power of high frequency) increased. At 4 weeks, morning cortisol was lower than baseline and 24 weeks. At 24 weeks, NEFA levels during OGTT, and the P LF /P HF  ratio decreased. None of these changes were seen in the control group.
CONCLUSIONS


There were rapid changes within 4 weeks after RYGB: signs of enhanced parasympathetic nerve activity, reduced morning cortisol, and enhanced incretin and glucagon responses to glucose. The findings suggest that neurohormonal mechanisms can contribute to the rapid improvement of insulin resistance and glycemia following RYGB in type 2 diabetes.",2020,At both 4 and 24 weeks post-RYGB the following effects were found: arginine-stimulated insulin secretion was reduced.,"['Nineteen obese patients with type 2 diabetes, 7 M/12 F', 'diabetes after Roux-en-Y Gastric Bypass (RYGB']",['RYGB or standard-of-care medical treatment (control'],"['insulin resistance and glycemia', 'GLP-1, GIP, and glucagon rise', 'enhanced parasympathetic nerve activity, reduced morning cortisol, and enhanced incretin and glucagon responses to glucose', 'total HRV and spectral components P LF  (power of low frequency) and P HF', 'IGF-1 and GH levels', 'morning cortisol', 'NEFA levels', 'fasting blood sampling, OGTT, intravenous arginine challenge, and heart-rate variability (HRV) assessments', 'arginine-stimulated insulin secretion']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0459522', 'cui_str': 'Parasympathetic nerve'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",19.0,0.029435,At both 4 and 24 weeks post-RYGB the following effects were found: arginine-stimulated insulin secretion was reduced.,"[{'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Katsogiannos', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Prasad G', 'Initials': 'PG', 'LastName': 'Kamble', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Wiklund', 'Affiliation': 'Radiation Sciences, Biomedical Engineering & Informatics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sundbom', 'Affiliation': 'Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Espes', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Hammar', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'F Anders', 'Initials': 'FA', 'LastName': 'Karlsson', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden. jan.eriksson@medsci.uu.se.'}]",Endocrine,['10.1007/s12020-020-02203-w']
1622,26869049,"Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial.","BACKGROUND


In metastatic breast cancer, nab-paclitaxel has been shown to significantly increase progression-free survival compared with solvent-based paclitaxel. The GeparSepto (GBG 69) trial assessed whether weekly nab-paclitaxel could increase the proportion of patients achieving pathological complete response compared with weekly solvent-based paclitaxel, both followed by epirubicin plus cyclophosphamide as neoadjuvant treatment.
METHOD


In a phase 3 randomised trial, we enrolled patients with previously untreated unilateral or bilateral primary invasive breast cancer and randomly assigned them in a 1:1 ratio using dynamic allocation and Pocock minimisation by breast cancer subtype, Ki67 and SPARC expression. Patients were treated for 12 weeks with either intravenous nab-paclitaxel 150 mg/m(2) (after study amendment, 125 mg/m(2)) on days 1, 8, and 15 for four 3-week cycles, or solvent-based intravenous paclitaxel 80 mg/m(2) on days 1, 8, and 15 for four 3-week cycles. Taxane treatment was followed in both groups by intravenous epirubicin 90 mg/m(2) plus intravenous cyclophosphamide 600 mg/m(2) on day 1 for four 3-week cycles. Patients with HER2-positive tumours received concurrent trastuzumab 6 mg/kg (loading dose 8 mg/kg) and pertuzumab 420 mg (loading dose 840 mg) on day 1 of every 3-week cycle. Trastuzumab and pertuzumab were given every 3 weeks concomitantly with chemotherapy for all cycles. This report is the final analysis of the primary endpoint, pathological complete response (ypT0 ypN0), analysed for all patients who started treatment (modified intention to treat). We used a closed test procedure to test for non-inferiority, with the nab-paclitaxel group calculated as non-inferior to the solvent-based paclitaxel group if the lower 95% CI for the OR was above 0·858 (OR equivalent to pathological complete response [33%] minus a 10% non-inferiority margin [3·3%]; 29·7%). We planned to test for superiority only in case of a positive non-inferiority test, using an α of 0·05. Safety was assessed in all patients who received study drug. The trial is registered with ClinicalTrials.gov, number NCT01583426.
FINDINGS


Between July 30, 2012, and Dec 23, 2013, we randomly assigned 1229 women, of whom 1206 started treatment (606 with nab-paclitaxel and 600 with solvent-based paclitaxel). The nab-paclitaxel dose was reduced after enrolment of 464 participants to 125 mg/m(2) due to increased treatment discontinuation and sensory neuropathy in this group. Pathological complete response occurred more frequently in the nab-paclitaxel group (233 [38%, 95% CI 35-42] patients) than in the solvent-based paclitaxel group (174 [29%, 25-33] patients; OR 1·53, 95% CI 1·20-1·95; unadjusted p=0·00065). The incidence of grade 3-4 anaemia (13 [2%] of 605 patients in the nab-paclitaxel group vs four [1%] of patients in the solvent-based paclitaxel group; p=0·048) and peripheral sensory neuropathy grade 3-4 (63 [10%] patients receiving any nab-paclitaxel dose; 31 [8%] of patients starting with 125 mg/m(2) and 32 [15%] of patients starting with 150 mg/m(2); vs 16 [3%] in the solvent-based paclitaxel group, p<0·001) was significantly higher for nab-paclitaxel than for solvent-based paclitaxel. Overall, 283 (23%) patients were noted to have at least one serious adverse event (based on study drug received), 156 (26%) in the nab-paclitaxel group and 127 (21%) in the solvent-based paclitaxel group (p=0·057). There were three deaths (during epirubicin plus cyclophosphamide treatment) in the nab-paclitaxel group (due to sepsis, diarrhoea, and accident unrelated to the trial) versus one in the solvent-based paclitaxel group (during paclitaxel treatment; cardiac failure).
INTERPRETATION


Substituting solvent-based paclitaxel with nab-paclitaxel significantly increases the proportion of patients achieving a pathological complete response rate after anthracycline-based chemotherapy. These results might lead to an exchange of the preferred taxane, solvent-based paclitaxel, for nab-paclitaxel in therapy for primary breast cancer.
FUNDING


Celgene, Roche.",2016,"Pathological complete response occurred more frequently in the nab-paclitaxel group (233 [38%, 95% CI 35-42] patients) than in the solvent-based paclitaxel group (174 [29%, 25-33] patients; OR 1·53, 95% CI 1·20-1·95; unadjusted p=0·00065).","['patients who started treatment (modified intention to treat', 'Between July 30, 2012, and Dec 23, 2013, we randomly assigned 1229 women, of whom 1206 started treatment (606 with nab', 'Patients with HER2-positive tumours', 'enrolled patients with previously untreated unilateral or bilateral primary invasive breast cancer', 'early breast cancer (GeparSepto-GBG 69', 'primary breast cancer']","['Taxane', 'Nab-paclitaxel versus solvent-based paclitaxel', 'Trastuzumab and pertuzumab', 'epirubicin plus cyclophosphamide', 'anthracycline-based chemotherapy', 'solvent-based intravenous paclitaxel', 'paclitaxel and 600 with solvent-based paclitaxel', 'epirubicin 90 mg/m(2) plus intravenous cyclophosphamide', 'paclitaxel with nab-paclitaxel', 'intravenous nab-paclitaxel', 'taxane, solvent-based paclitaxel', 'nab-paclitaxel', 'concurrent trastuzumab 6 mg/kg (loading dose 8 mg/kg) and pertuzumab']","['peripheral sensory neuropathy grade', 'proportion of patients achieving a pathological complete response rate', 'proportion of patients achieving pathological complete response', 'progression-free survival', 'incidence of grade 3-4 anaemia', 'Pathological complete response', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036883', 'cui_str': 'Sex Steroid-Binding Protein'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0037638', 'cui_str': 'Solvents'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}]","[{'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1229.0,0.0977557,"Pathological complete response occurred more frequently in the nab-paclitaxel group (233 [38%, 95% CI 35-42] patients) than in the solvent-based paclitaxel group (174 [29%, 25-33] patients; OR 1·53, 95% CI 1·20-1·95; unadjusted p=0·00065).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'HELIOS Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Conrad', 'Affiliation': 'St Elisabeth Krankenhaus, Kassel, Germany.'}, {'ForeName': 'Bahriye', 'Initials': 'B', 'LastName': 'Aktas', 'Affiliation': ""University Women's Hospital Essen, Essen, Germany.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital Charité, Department of Pathology, Berlin, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Eidtmann', 'Affiliation': 'University Hospital Kiel, Kiel, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wiebringhaus', 'Affiliation': 'St Barbara-Klinik Hamm-Heessen, Hamm, Germany.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Interdisziplinäres Brustzentrum an den Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Hilfrich', 'Affiliation': 'Krankenhaus Eilenriede, Hannover, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Warm', 'Affiliation': 'Brustzentrum im Krankenhaus Köln-Holweide, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Paepke', 'Affiliation': 'Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde, Munich, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Just', 'Affiliation': 'Onkologische Schwerpunktpraxis, Bielefeld, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Klinikum zum Roten Kreuz, Munich, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hackmann', 'Affiliation': 'Marien Hospital Witten, Witten, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Klinik für Gynäkologie am Campus Charité Mitte, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clemens', 'Affiliation': 'Klinikum Mutterhaus der Borromäerinnen, Trier, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Darb-Esfahani', 'Affiliation': 'University Hospital Charité, Department of Pathology, Berlin, Germany.'}, {'ForeName': 'Wolfgang Daniel', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'University Hospital Charité, Department of Pathology, Berlin, Germany.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Dan Costa', 'Affiliation': 'Universitäts-Frauenklinik, Magdeburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Universitäts-Frauenklinik, Rostock, Germany.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Engels', 'Affiliation': 'Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany. Electronic address: sibylle.loibl@gbg.de.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(15)00542-2']
1623,32090630,Long-Term Favorable Effects of Physical Exercise on Burdensome Symptoms in the OptiTrain Breast Cancer Randomized Controlled Trial.,"Purpose:  We evaluate longitudinal changes in symptom clusters and core burdensome symptoms in breast cancer patients who participated in the OptiTrain trial.  Methods:  240 women were randomized to 16 weeks of supervised exercise (RT-HIIT or AT-HIIT) or usual care (UC) during adjuvant chemotherapy. Symptom clusters were composed using the Memorial Symptom Assessment Scale (MSAS), assessed at baseline, 16 weeks and 12 months later. Three symptom clusters were formed.  Results:  Three symptom clusters were identified: ""emotional,"" ""treatment-related toxicity,"" and ""physical,"" with core burdensome symptoms present over time. At 16 weeks, the reported burdens of ""feeling sad"" (RT-HIIT vs UC: effect size [ES] = -0.69; AT-HIIT vs UC: ES = -0.56) and ""feeling irritable"" (ES = -0.41 RT-HIIT; ES = -0.31 AT-HIIT) were significantly lower in both intervention groups compared with UC. At 12 months, the AT-HIIT group continued to have significantly lower scores for the core burdensome symptoms ""feeling sad"" (ES = -0.44), ""feeling irritable"" (ES = -0.44), and ""changes in the way food tastes"" (ES = -0.53) compared with UC. No between-group differences were found for physical symptoms.  Conclusion:  We identified 3 symptom clusters in breast cancer patients during and after adjuvant chemotherapy, composed of ""emotional,"" ""treatment-related toxicity,"" and ""physical"" symptoms. After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC. Our findings indicate a preserved and long-term beneficial effect of physical exercise on self-reported emotional well-being in chemotherapy-treated breast cancer patients.",2020,"After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC.","['breast cancer patients during and after adjuvant chemotherapy, composed of ""emotional,"" ""treatment-related toxicity,"" and ""physical"" symptoms', '240 women', 'chemotherapy-treated breast cancer patients', 'breast cancer patients who participated in the OptiTrain trial']","['physical exercise', 'Physical Exercise', 'supervised exercise (RT-HIIT or AT-HIIT) or usual care (UC) during adjuvant chemotherapy']","['Memorial Symptom Assessment Scale (MSAS', 'feeling irritable', 'symptom burden scores for emotional symptoms', 'Burdensome Symptoms', 'burdens of ""feeling sad"" (RT-HIIT vs UC: effect size [ES', 'physical symptoms']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",240.0,0.055644,"After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC.","[{'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Wiggenraad', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elsken', 'Initials': 'E', 'LastName': 'van der Wall', 'Affiliation': 'University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Renske', 'Initials': 'R', 'LastName': 'Altena', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}]",Integrative cancer therapies,['10.1177/1534735420905003']
1624,30852837,"Intra-operative Oxycodone Reduced Postoperative Catheter-Related Bladder Discomfort Undergoing Transurethral Resection Prostate. A Prospective, Double Blind Randomized Study.","PURPOSE


To observe the efficacy of intravenously injected oxycodone intraoperative on postoperative urinary catheter-related bladder discomfort (CRBD).
MATERIALS AND METHODS


Patients with ASA I-III received trans-urethral resection prostate under general anesthesia were observed. Patients were randomized allocated to the group control (n = 45) received placebo and the group oxycodone (n =46 ) received 0.03mg/kg of oxycodone before the end of operative 10min. The incidence and severity (mild, moderate, severe) of CRBD were assessed at 0, 1/2 h, 2 h and 6 h postoperatively. VAS scores were used to assess pain intensity during the same period. Postoperative PCA analgesic sufentanil dose and the incidences of nausea, vomiting, dizziness, over sedation were recorded in these patients.
RESULTS


Compared with the control group, the incidence of CRBD was significantly lower in the oxycodone group at 0 [22 (49 %) vs. 10 (22%); P = .007], 1/2h [18 (40%) vs. 9 (20%); P= .033], 2h [11 (24%) vs. 4 (9%); P = .001]. The severity of CRBD at 0 [mild, 9 (38%) ; moderate 9 (20%), severe 4 (9%)] was lower in the group Q than the controlled group [mild, 4 (38%) P ? .023; moderate 5 (11%), P ?.034, severe 1 (2%), P ? .012]. 1/2 h [mild, 11 (24%) Vs 5(11%), P ? .020]. Compared with the group C, VAS scores were lower in group Q at 0, 1/2h (P ? .001) and significantly decreased sufentanil dosage within 6h ( P= .001). There were no significant differences in the incidence of postoperative adverse effects between two groups.
CONCLUSION


Oxycodone can effectively prevent patients with CRBD after TURP without incurring serious adverse effects.",2019,"Compared with the group C, VAS scores were lower in group Q at 0, 1/2h",['Patients with ASA I-III received'],"['placebo and the group oxycodone', 'oxycodone', 'trans-urethral resection prostate under general anesthesia', 'Oxycodone', 'oxycodone intraoperative', 'Intra-operative Oxycodone Reduced Postoperative Catheter-Related Bladder Discomfort Undergoing Transurethral Resection Prostate']","['severity of CRBD', 'incidence of CRBD', 'incidence and severity (mild, moderate, severe) of CRBD', 'incidence of postoperative adverse effects', 'nausea, vomiting, dizziness, over sedation', 'postoperative urinary catheter-related bladder discomfort (CRBD', 'VAS scores', 'pain intensity', 'sufentanil dosage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",,0.162857,"Compared with the group C, VAS scores were lower in group Q at 0, 1/2h","[{'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Weng', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Shuqun', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang Ouhai District of Wenzhou, Zhejiang, P. R. China, 325000.'}]",Urology journal,['10.22037/uj.v0i0.4267']
1625,32141054,Can coffee consumption be used to accelerate the recovery of bowel function after cesarean section? Randomized prospective trial.,"OBJECTIVES


To evaluate whether coffee consumption accelerates the recovery of bowel function after cesarean section or not.
MATERIAL AND METHODS


This study was designed as randomized controlled study. Patients were randomly assigned to one of two groups: Ultimately, Group 1 (n = 51) was the study group and drank three cups of coffee after cesarean, whereas group 2 (n = 52) was not given any treatment. The primary outcome measure was the time to first defecation after surgery, the secondary outcomes were time to first bowel movement, passage of flatus, time to toleration of a solid diet, additional antiemetic and analgesic requirement.
RESULTS


There were no significant differences in demographic variables between the groups. The mean time to passage of first flatus was significantly shorter in the study group than the control group (8.6 ± 3.3 h vs 11.3 ± 7.5 h, respectively; p = 0.022). First defecation was 20.7 ± 11.5 h for the study group and at 29.1 ± 14.3 h for the control group (p = 0.001). In addition, there was a significant difference in mean time to toleration of solid food between the study and control groups (8.78 ± 2.33 h vs 12.88 ± 4.2.60 h, respectively; p < 0.001).
CONCLUSIONS


Coffee can be used in patients to enhance the recovery of gastrointestinal function after elective cesarean section.",2020,"In addition, there was a significant difference in mean time to toleration of solid food between the study and control groups (8.78 ± 2.33 h vs 12.88 ± 4.2.60 h, respectively; p < 0.001).
",[],[],"['First defecation', 'time to first defecation after surgery, the secondary outcomes were time to first bowel movement, passage of flatus, time to toleration of a solid diet, additional antiemetic and analgesic requirement', 'mean time to passage of first flatus', 'demographic variables', 'mean time to toleration of solid food']",[],[],"[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0453855', 'cui_str': 'Solid food (substance)'}]",52.0,0.0881402,"In addition, there was a significant difference in mean time to toleration of solid food between the study and control groups (8.78 ± 2.33 h vs 12.88 ± 4.2.60 h, respectively; p < 0.001).
","[{'ForeName': 'Sezen', 'Initials': 'S', 'LastName': 'Bozkurt Koseoglu', 'Affiliation': 'Mugla Sıtkı Kocman University Training and Research Hospital, Department Of Gynecology and Obstetrics, Turkey.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Korkmaz Toker', 'Affiliation': 'Mugla Sıtkı Kocman University, Training and Research Hospital, Department of Anesthesiology and Reanimation, Turkey. meltoker@gmail.com.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gokbel', 'Affiliation': 'Mugla Sıtkı Kocman University Training and Research Hospital, Department Of Gynecology and Obstetrics, Turkey.'}, {'ForeName': 'Ozgu', 'Initials': 'O', 'LastName': 'Celikkol', 'Affiliation': 'Mugla Sıtkı Kocman University Training and Research Hospital, Department Of Gynecology and Obstetrics, Turkey.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Gungorduk', 'Affiliation': 'Mugla Sıtkı Kocman University Training and Research Hospital, Department Of Gynecology and Obstetrics, Turkey.'}]",Ginekologia polska,['10.5603/GP.2020.0014']
1626,32227108,Music Therapist Experiences of a Randomized Controlled Trial as Clinician Researchers.,"Music therapy clinicians bring an important perspective to the design and conduct of clinically meaningful studies. Unfortunately, there continue to be roadblocks that hinder clinician involvement in research and the development of successful partnerships between academic researchers and practicing clinicians. To help grow clinician involvement, it is important that research teams share their experiences. As such, the purpose of this qualitative study was to share music therapists' perspectives about their experience of working as a research clinician on a large multisite randomized controlled trial. 10 board-certified music therapists provided written responses to 6 data-generating questions about: (a) reasons for participating, (b) perceived challenges and benefits, (c) experiences of quality assurance monitoring, (d) professional growth, (e) value of research, and (f) advice for clinicians considering research involvement. Using thematic content analysis, we identified primary themes and subthemes for each question (20 themes; 30 subthemes). Qualitative analysis revealed not only common challenges, such as reconciling clinical and research responsibilities, but also benefits, including continued professional growth, greater understanding of research processes, and research participation as a way to advocate and advance the profession. Finally, for clinicians interested in becoming involved in research, therapists noted the importance of having workplace support from a mentor, supervisor, and/or administrator; seeking out available resources; and knowing roles and responsibilities before initiating research involvement. Findings offer important insight and recommendations to support the involvement of clinicians in research and support further exploration of clinician involvement in dissemination efforts to improve translation and uptake of research into practice.",2020,"Unfortunately, there continue to be roadblocks that hinder clinician involvement in research and the development of successful partnerships between academic researchers and practicing clinicians.",[],[],[],[],[],[],10.0,0.0426504,"Unfortunately, there continue to be roadblocks that hinder clinician involvement in research and the development of successful partnerships between academic researchers and practicing clinicians.","[{'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Henley', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Collier', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': ""Children's Mercy Hospital, Kansas City, MO.""}, {'ForeName': 'Marial A', 'Initials': 'MA', 'LastName': 'Biard', 'Affiliation': ""Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Bruno', 'Affiliation': 'Eating Recovery Center of Ohio, Cincinnati, OH.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Bush', 'Affiliation': 'West Virginia University, Morgantown, WV.'}, {'ForeName': 'Erinn', 'Initials': 'E', 'LastName': 'Frees', 'Affiliation': ""Children's Minnesota, Minneapolis, MN.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Krater', 'Affiliation': 'Riley Hospital for Children at Indiana University Health, Indianapolis, IN.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Woolever', 'Affiliation': ""Children's Minnesota, Minneapolis, MN.""}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Burns', 'Affiliation': 'School of Engineering and Technology at IUPUI Department of Music and Arts Technology, Indianapolis, IN.'}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Robb', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN.'}]",Journal of music therapy,['10.1093/jmt/thaa005']
1627,32220393,Incorporating Hourly Rounding to Increase Emergency Department Patient Satisfaction: A Quality Improvement Approach.,"PROBLEM


Patient satisfaction is an important factor that influences the perceived quality of care delivered. In an effort to meet patient expectations, a process improvement initiative involving hourly rounding was implemented to improve low patient satisfaction scores.
METHODS


This project took place over 23 months and consisted of 4 phases (baseline, intervention I, break, and intervention II). During the intervention phases, self-reported hourly rounding was tracked on a daily basis. Compliance with rounding and patient satisfaction results were provided to staff during unit meetings and were displayed on a visual tracker board. Weekly 5-minute customer service training was provided to all staff. During the baseline and break phases, hourly rounding was not tracked. However, patient satisfaction data were still collected through the Interactive Customer Evaluation system. Three variables were measured using a 5-point Likert scale: overall patient satisfaction, patient perception of staff attitude, and whether the health care team answered all patient questions/concerns.
RESULTS


Hourly rounding compliance was 39% during intervention I and 51% during intervention II. Approximately 0.01% of patients submitted satisfaction data. From baseline to conclusion of intervention II, overall patient satisfaction increased from 52% to 73%; perception of staff attitude increased from 70% to 84%; and whether the health care team answered all patient questions/concerns increased from 63% to 81%.
DISCUSSION


There is a positive relationship between hourly rounding and patient satisfaction scores. Despite low compliance with hourly rounding, patient satisfaction increased for all 3 variables measured. To achieve a change in culture with hourly rounding compliance, nurse managers must consistently monitor staff compliance with hourly rounding.",2020,"From baseline to conclusion of intervention II, overall patient satisfaction increased from 52% to 73%; perception of staff attitude increased from 70% to 84%; and whether the health care team answered all patient questions/concerns increased from 63% to 81%.
",[],[],"['perception of staff attitude', 'overall patient satisfaction', '5-point Likert scale: overall patient satisfaction, patient perception of staff attitude, and whether the health care team answered all patient questions/concerns', 'patient satisfaction']",[],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038122', 'cui_str': 'Staff Attitude'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086390', 'cui_str': 'Medical Care Team'}]",3.0,0.0368272,"From baseline to conclusion of intervention II, overall patient satisfaction increased from 52% to 73%; perception of staff attitude increased from 70% to 84%; and whether the health care team answered all patient questions/concerns increased from 63% to 81%.
","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Brosinski', 'Affiliation': ''}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Riddell', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2019.08.004']
1628,32496736,Exercise Training Impacts Skeletal Muscle Clock in Adults with Prediabetes.,"PURPOSE


Disruption of the skeletal muscle molecular clock leads to metabolic disease, while exercise may be restorative, leading to improvements in metabolic health. The purpose of this study was to evaluate the effects of a 12-week exercise intervention on skeletal muscle molecular clock machinery in adults with obesity and prediabetes, and determine whether these changes were related to exercise-induced improvements in metabolic health.
METHODS


Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week exercise intervention and were fully provided isoenergetic diets. Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy) were assessed at baseline and after intervention. Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER 1/2 were measured by quantitative real-time PCR and Western blot, respectively.
RESULTS


Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max) all improved (P<0.005) with exercise training. Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged. The fold change in BMAL1 correlated with post GDR (r=0.43, P=0.044), BMI (r=-0.44, P=0.042), and body weight changes (r=-0.44, P=0.039) expressed as percent delta.
CONCLUSION


Exercise training impacts skeletal muscle molecular clock machinery in a clinically-relevant cohort of adults with obesity and prediabetes. Skeletal muscle BMAL1 gene expression may improve insulin sensitivity. Future studies are needed to determine the physiological significance of exercise-induced alterations in skeletal muscle clock machinery.",2020,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","['Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week', 'adults with obesity and prediabetes', 'Adults with Prediabetes']","['exercise intervention', 'Exercise training', 'Exercise Training', 'exercise intervention and were fully provided isoenergetic diets']","['Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy', 'Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max', 'Skeletal muscle BMAL1 gene', 'PER2 protein expression', 'BMAL1', 'BMI', 'while CLOCK, CRY1/2 and PER1', 'Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER', 'body weight changes']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0337076', 'cui_str': 'Industrial machine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",26.0,0.0285188,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002368']
1629,32498426,"Amino Acid Plasma Profiles from a Prolonged-Release Protein Substitute for Phenylketonuria: A Randomized, Single-Dose, Four-Way Crossover Trial in Healthy Volunteers.","Several disorders of amino acid (AA) metabolism are treated with a protein-restricted diet supplemented with specific AA mixtures. Delivery kinetics impacts AA absorption and plasma concentration profiles. We assessed plasma profiles after ingestion of an AA mixture engineered to prolong AA absorption with Physiomimic Technology TM  (Test) in a randomized, single-dose, four-way crossover trial in healthy volunteers (Trial Registration: ISRCTN11016729). In a two-step hypothesis, the primary endpoints were (i) significant reduction in peak plasma concentrations (C max ) of essential amino acids (EAAs) while (ii) maintaining EAA bioavailability (AUC 0-300 min ) compared to a free AA mixture (Reference). Secondary endpoints included effects on plasma profiles of other AA groups and effects on several metabolic markers. Thirty subjects completed the study. Both co-primary endpoints were met: C max  for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726,  p  < 0.0001); overall plasma EAA levels from the two AA mixtures was within the pre-specified bioequivalence range (AUC 0-300min  ratio, 0.890 (95% CI: 0.865, 0.915)). These findings were supported by the results of secondary endpoints. Prolongation of AA absorption was associated with modulation of several metabolic markers. It will be important to understand whether this can improve the long-term management of disorders of AA metabolism.",2020,"C max  for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726,  ","['Phenylketonuria', 'Healthy Volunteers', 'healthy volunteers', 'Thirty subjects completed the study']",[],"['C max  for EAAs', 'plasma EAA levels', 'peak plasma concentrations (C max ) of essential amino acids (EAAs) while (ii) maintaining EAA bioavailability', 'Prolongation of AA absorption', 'plasma profiles of other AA groups and effects on several metabolic markers']","[{'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0243046', 'cui_str': 'Excitatory Amino Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}]",30.0,0.186598,"C max  for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726,  ","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'CRST Oy, Itäinen Pitkäkatu 4B, FI-20520 Turku, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Barassi', 'Affiliation': 'APR Applied Pharma Research sa via Corti 5, CH-6828 Balerna, Switzerland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Junnila', 'Affiliation': 'Oy 4Pharma Ltd., Arkadiankatu 7, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'CRST Oy, Itäinen Pitkäkatu 4B, FI-20520 Turku, Finland.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Reiner', 'Affiliation': 'APR Applied Pharma Research sa via Corti 5, CH-6828 Balerna, Switzerland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Sarkkinen', 'Affiliation': 'Food and Nutrition, Oy Medfiles Ltd. (CRO), P. O. Box 1450, FI-70701 Kuopio, Finland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': ""Dietetic Department, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}]",Nutrients,['10.3390/nu12061653']
1630,32500130,"Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.","OBJECTIVE


Perceived stress and musculoskeletal pain are common, especially in low-income populations. Studies evaluating treatments to reduce stress in patients with chronic pain are lacking. We aimed to quantify the effect of two evidence-based interventions for chronic low back pain (cLBP), yoga and physical therapy (PT), on perceived stress in adults with cLBP.
METHODS


We used data from an assessor-blinded, parallel-group randomized controlled trial, which recruited predominantly low-income and racially diverse adults with cLBP. Participants (N = 320) were randomly assigned to 12 weeks of yoga, PT, or back pain education. We compared changes in the 10-item Perceived Stress Scale (PSS-10) from baseline to 12- and 52-week follow-up among yoga and PT participants with those receiving education. Subanalyses were conducted for participants with elevated pre-intervention perceived stress (PSS-10 score ≥17). We conducted sensitivity analyses using various imputation methods to account for potential biases in our estimates due to missing data.
RESULTS


Among 248 participants (mean age = 46.4 years, 80% nonwhite) completing all three surveys, yoga and PT showed greater reductions in PSS-10 scores compared with education at 12 weeks (mean between-group difference = -2.6, 95% confidence interval [CI] = -4.5 to -0.66, and mean between-group difference = -2.4, 95% CI = -4.4 to -0.48, respectively). This effect was stronger among participants with elevated pre-intervention perceived stress. Between-group effects had attenuated by 52 weeks. Results were similar in sensitivity analyses.
CONCLUSIONS


Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.",2020,"CONCLUSIONS


Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","['patients with chronic pain are lacking', '248 participants (mean age = 46.4 years, 80% nonwhite', 'adults with cLBP', 'recruited predominantly low-income and racially diverse adults with cLBP', 'Chronic Low Back Pain', 'Participants (N\u2009=\u2009320']","['Physical Therapy, and Education Interventions', 'Yoga and PT', 'yoga and physical therapy (PT']","['PSS-10 scores', '10-item Perceived Stress Scale (PSS-10', 'Perceived Stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",320.0,0.203356,"CONCLUSIONS


Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'Department of Rehabilitation Science, Massachusetts General Hospital Institute of Health Professions, Boston, Massachusetts.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fredman', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa150']
1631,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND


There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS


In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS


At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION


Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
1632,32235144,Multimodal Analgesic Regimen for Spine Surgery: A Randomized Placebo-controlled Trial.,"BACKGROUND


Various multimodal analgesic approaches have been proposed for spine surgery. The authors evaluated the effect of using a combination of four nonopioid analgesics versus placebo on Quality of Recovery, postoperative opioid consumption, and pain scores.
METHODS


Adults having multilevel spine surgery who were at high risk for postoperative pain were double-blind randomized to placebos or the combination of single preoperative oral doses of acetaminophen 1,000 mg and gabapentin 600 mg, an infusion of ketamine 5 µg/kg/min throughout surgery, and an infusion of lidocaine 1.5 mg/kg/h intraoperatively and during the initial hour of recovery. Postoperative analgesia included acetaminophen, gabapentin, and opioids. The primary outcome was the Quality of Recovery 15-questionnaire (0 to 150 points, with 15% considered to be a clinically important difference) assessed on the third postoperative day. Secondary outcomes were opioid use in morphine equivalents (with 20% considered to be a clinically important change) and verbal-response pain scores (0 to 10, with a 1-point change considered important) over the initial postoperative 48 h.
RESULTS


The trial was stopped early for futility per a priori guidelines. The average duration ± SD of surgery was 5.4 ± 2.1 h. The mean ± SD Quality of Recovery score was 109 ± 25 in the pathway patients (n = 150) versus 109 ± 23 in the placebo group (n = 149); estimated difference in means was 0 (95% CI, -6 to 6, P = 0.920). Pain management within the initial 48 postoperative hours was not superior in analgesic pathway group: 48-h opioid consumption median (Q1, Q3) was 72 (48, 113) mg in the analgesic pathway group and 75 (50, 152) mg in the placebo group, with the difference in medians being -9 (97.5% CI, -23 to 5, P = 0.175) mg. Mean 48-h pain scores were 4.8 ± 1.8 in the analgesic pathway group versus 5.2 ± 1.9 in the placebo group, with the difference in means being -0.4 (97.5% CI; -0.8, 0.1, P = 0.094).
CONCLUSIONS


An analgesic pathway based on preoperative acetaminophen and gabapentin, combined with intraoperative infusions of lidocaine and ketamine, did not improve recovery in patients who had multilevel spine surgery.",2020,"Pain management within the initial 48 postoperative hours was not superior in analgesic pathway group: 48-h opioid consumption median (Q1, Q3) was 72 (48, 113) mg in the analgesic pathway group and 75 (50, 152)","['spine surgery patients', 'Spine Surgery', 'patients who had multilevel spine surgery', 'spine surgery', 'Adults having multilevel spine surgery who were at high risk for postoperative pain']","['placebo', 'acetaminophen and gabapentin', 'acetaminophen, gabapentin, ketamine, and lidocaineThe Quality of Recovery', 'placebos', 'Placebo', 'acetaminophen 1,000 mg and gabapentin 600 mg, an infusion of ketamine', 'lidocaine and ketamine', 'acetaminophen, gabapentin, and opioids', 'lidocaine', 'Multimodal Analgesic Regimen', 'nonopioid analgesics versus placebo']","['Quality of Recovery 15-questionnaire', 'Pain management', 'opioid use in morphine equivalents', 'mean ± SD Quality of Recovery score', 'Quality of Recovery, postoperative opioid consumption, and pain scores', 'Mean 48-h pain scores', 'verbal-response pain scores']","[{'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1154156', 'cui_str': 'gabapentin 600 MG'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",,0.753593,"Pain management within the initial 48 postoperative hours was not superior in analgesic pathway group: 48-h opioid consumption median (Q1, Q3) was 72 (48, 113) mg in the analgesic pathway group and 75 (50, 152)","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'From the Department of General Anesthesiology (K.M., R.A., D.T., S.R., M.M., S.M., A. Kurz) Department of Quantitative Health Sciences (N.M.) Department of Neurosurgery (A. Krishnaney, A.M.) Department of Pain Management (R.R.) Department of Outcomes Research (K.M., D.I.S., N.M., M.T., S.R., A. Kurz), Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Rafi', 'Initials': 'R', 'LastName': 'Avitsian', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': ''}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Tanios', 'Affiliation': ''}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Traul', 'Affiliation': ''}, {'ForeName': 'Shobana', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': ''}, {'ForeName': 'Mariel', 'Initials': 'M', 'LastName': 'Manlapaz', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Machado', 'Affiliation': ''}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Krishnaney', 'Affiliation': ''}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rosenquist', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003143']
1633,32500725,Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies.,"BACKGROUND


Switching between antiarrhythmic drugs is timed to minimize arrhythmia recurrence and adverse reactions. Dronedarone and amiodarone have similar electrophysiological profiles; however, little is known about the optimal timing of switching, given the long half-life of amiodarone.
METHODS


The ARTEMIS atrial fibrillation (AF) Loading and Long-term studies evaluated switching patients with paroxysmal/persistent AF from amiodarone to dronedarone. Patients were randomized based on the timing of the switch: immediate, after a 2-week, or after a 4-week washout of amiodarone. Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion. The primary objectives were, for the Loading study, to evaluate recurrence of AF ≤60 days; and for the Long-term study, to profile the pharmacokinetics of dronedarone and its metabolite according to different timings of dronedarone initiation.
RESULTS


In ARTEMIS AF Loading, 176 were randomized (planned 768) after a 28 ± 2 days load of oral amiodarone. Atrial fibrillation recurrence trended less in the immediate switch versus 4-week washout group (hazard ratio [HR] = 0.65 [97.5% CI: 0.34-1.23];  P  = .14) and in the 2-week washout versus the 4-week washout group (HR = 0.75 [97.5% CI: 0.41-1.37];  P  = .32). In ARTEMIS AF Long-term, 108 patients were randomized (planned 105). Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
CONCLUSION


The trial was terminated early due to poor recruitment and so our findings are limited by low numbers. However, immediate switching from amiodarone to dronedarone appeared to be well tolerated and safe.",2020,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","['108 patients were randomized (planned 105', 'Patients With Atrial Fibrillation', 'Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion', 'patients with paroxysmal/persistent AF from']","['dronedarone', 'amiodarone to dronedarone', 'amiodarone', 'Dronedarone', 'Amiodarone']","['Atrial fibrillation recurrence', 'tolerated and safe']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",108.0,0.0279373,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","[{'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Division of Cardiology, Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St George's University of London, London, UK.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Le Heuzey', 'Affiliation': 'Hôpital Européen Georges Pompidou, Université Paris V René Descartes, Paris, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lombardi', 'Affiliation': 'Cardiologia, Fondazione IRCCS Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Tamargo', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Medicine, CIBERCV, University Complutense, Madrid, Spain.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Martinez', 'Affiliation': 'Sanofi, Montpellier, France.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Naditch-Brûlé', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420926874']
1634,32497586,Cardiovascular adaptations after 10 months of daily 12-min bouts of intense school-based physical training for 8-10-year-old children.,"The present study examined cardiovascular adaptations in 8-10-year-old schoolchildren after a full school year (10 months) of 5 × 12 min/wk. of intense physical training, including small-sided ball games (soccer, basketball and floorball) or interval running. The study involved 8-10-year-old healthy Danish schoolchildren (n = 232), who were cluster-randomized to a small-sided games group (SSG, n = 60), an interval running group (IR, n = 57) or a control group (CON, n = 115). Comprehensive transthoracic echocardiography, resting heart rate and blood pressure measurements were performed at baseline and post intervention. For interval running, analysis of baseline-to-10-months changes showed significant (P < 0.05) between-group differences in delta scores for diastolic blood pressure (BP) and mean arterial BP (IR -3.2 ± 5.7 and - 2.2 ± 6.5 mmHg vs. CON 0.2 ± 5.3 and 0.4 ± 6.4 mmHg, respectively). Delta scores also showed a trend for reduction of mean arterial BP in SSG compared to CON (-2.1 ± 6.0 vs. 0.2 ± 5.3 mmHg, P = 0.067). Moreover, there were between-group differences in delta scores (P < 0.05) for selected echocardiographic parameters, i.e. in SSG vs. CON for interventricular septum thickness and peak transmitral flow velocity in early diastole, and in IR vs. CON for left ventricular systolic diameter. In conclusion, 10 months of 5 × 12 min/wk. of IR in 8-10-year-old children decreased diastolic BP, while both IR and SSG elicited cardiac adaptations. The results suggest that frequent low volume, intense physical training can have effects on the cardiovascular health profile in healthy children.",2020,"Moreover, there were between-group differences in delta scores (P < 0.05) for selected echocardiographic parameters, i.e. in SSG vs. CON for interventricular septum thickness and peak transmitral flow velocity in early diastole, and in IR vs. CON for left ventricular systolic diameter.","['8-10-year-old schoolchildren after a full school year (10\u202fmonths) of 5\u202f×\u202f12\u202fmin/wk', '8-10-year-old children', '8-10-year-old healthy Danish schoolchildren (n\u202f=\u202f232', 'healthy children']","['small-sided games group (SSG, n\u202f=\u202f60), an interval running group (IR, n\u202f=\u202f57) or a control group (CON', 'intense school-based physical training', 'intense physical training, including small-sided ball games (soccer, basketball and floorball) or interval running']","['delta scores for diastolic blood pressure (BP) and mean arterial BP', 'Cardiovascular adaptations', 'diastolic BP', 'Delta scores', 'mean arterial BP', 'Comprehensive transthoracic echocardiography, resting heart rate and blood pressure measurements', 'delta scores', 'interventricular septum thickness and peak transmitral flow velocity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0225870', 'cui_str': 'Interventricular septum structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.050631,"Moreover, there were between-group differences in delta scores (P < 0.05) for selected echocardiographic parameters, i.e. in SSG vs. CON for interventricular septum thickness and peak transmitral flow velocity in early diastole, and in IR vs. CON for left ventricular systolic diameter.","[{'ForeName': 'Malte Nejst', 'Initials': 'MN', 'LastName': 'Larsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; Department of Nutrition, Exercise and Sports, Copenhagen Centre for Team Sport and Health, University of Copenhagen, Copenhagen, Denmark. Electronic address: mnlarsen@health.sdu.dk.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Madsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Claus Malta', 'Initials': 'CM', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen Centre for Team Sport and Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Manniche', 'Affiliation': 'LIVA Group, Copenhagen, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'Team Denmark, Brøndby, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen Centre for Team Sport and Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Peter Riis', 'Initials': 'PR', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte University Hospital, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.05.011']
1635,32502772,The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.,"OBJECTIVE


To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS).
DESIGN


Single centre double blind randomised controlled trial.
PARTICIPANTS


Women aged 18 years or over who had a CS.
INTERVENTIONS


All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group).
MAIN OUTCOME MEASURES


The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate.
RESULTS


324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups.
CONCLUSIONS


This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.",2020,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","['Women aged 18 years or over who had a CS', '324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group', 'surgical site infection following caesarean section']","['caesarean section (CS', 'copper impregnated wound dressings', 'copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group']","['SSI rates', 'infection rate', 'length of hospital stay, and readmission rate', 'incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire', 'surgical site infection (SSI) rate', 'Length of hospital stay, and readmission rate', 'incidence of superficial/deep SSI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",324.0,0.239103,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","[{'ForeName': 'Linda P', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Research Fellow, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: l.p.arendsen@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Consultant Obstetrician and Urogynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: ranee.thakar@nhs.net.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, Amersham, United Kingdom. Electronic address: paul@statsconsultancy.co.uk.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Consultant Obstetrician and UroGynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, Croydon, CR7 7YE, United Kingdom Honorary Reader, St George's University of London. Electronic address: abdulsultan@nhs.net.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.016']
1636,32502775,"Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial.","STUDY OBJECTIVE


Comparison of ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB) in patients undergoing total hip arthroplasty (THA).
DESIGN


Randomized equivalence trial.
SETTING


University Hospital.
PATIENTS


Sixty patients undergoing primary THA.
INTERVENTIONS


Patients were randomly allocated to receive ultrasound-guided LPB (n = 30) or SIFIB (n = 30). The local anesthetic agent (40 mL of levobupivacaine 0.25% with epinephrine 5 μg/mL) and block adjuvant (4 mg of intravenous dexamethasone) were identical in all subjects. Postoperatively, all patients received patient-controlled intravenous analgesia (morphine) as well as acetaminophen and ketoprofen during 48 h.
MEASUREMENTS


A blinded investigator recorded morphine consumption at 24 and 48 h as well as time to first morphine request, pain scores at 3, 6, 12, 24 and 48 h, incidence of adverse events, time to readiness for discharge, and length of hospital stay. The blinded investigator also carried out sensorimotor block assessment at 3, 6 and 24 h using a 10-point sensorimotor composite scale.
MAIN RESULTS


No intergroup differences were found in terms of cumulative morphine consumption at 24 h (95% CI: -4.0 mg to 2.0 mg) and 48 h (95% CI, -5.0 mg to 2.0 mg) or time to first morphine request. Furthermore, pain scores were similar at all time intervals after 3 h. There were no intergroup differences in terms of composite sensorimotor scores at 3 and 6 h. However, SIFIB lasted longer than lumbar plexus block as evidenced by a higher composite score at 24 h. No intergroup differences were found in terms of complications. Compared with LPB, SIFIB was associated with shorter time to readiness for discharge (3 [1-4] vs. 2 [1-3] days; P = 0.042) and length of hospital stay (3 [2-5] vs. 3 [2-4] days; P = 0.048).
CONCLUSIONS


For THA, no differences were found between LPB and SIFIB in terms of breakthrough morphine requirement and pain control. However, SIFIB resulted in a longer block and was associated with shorter time to readiness for discharge as well as decreased hospital stay.",2020,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"['Sixty patients undergoing primary THA', 'University Hospital', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['block adjuvant (4\xa0mg of intravenous dexamethasone', 'acetaminophen and ketoprofen', 'levobupivacaine', 'ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB', 'epinephrine', 'patient-controlled intravenous analgesia (morphine', 'ultrasound-guided LPB', 'Lumbar plexus block versus suprainguinal fascia iliaca block']","['shorter time to readiness for discharge', 'breakthrough morphine requirement and pain control', 'cumulative morphine consumption', 'length of hospital stay', 'complications', 'composite sensorimotor scores', 'adverse events, time to readiness for discharge, and length of hospital stay', 'hospital stay', 'Furthermore, pain scores', 'morphine consumption at 24 and 48\xa0h as well as time to first morphine request, pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",60.0,0.130543,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456. Electronic address: dbravoadvis@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Barrientos', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Wulf', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Montreal General Hospital, Department of Anesthesiology, McGill University, 1650 Ave Cedar, D10-D144, Montreal, Quebec H3G-1A4, Canada.'}, {'ForeName': 'De Q', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': ""St. Mary's Hospital, Department of Anesthesiology, McGill University, 3830 Ave Lacombe, Montreal, Quebec H3T-1M5, Canada.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109907']
1637,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND


Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities.
RESEARCH QUESTION


Is underwater gait training or overground gait training more effective in severe stroke patients?
METHODS


A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training.
RESULTS


Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm).
SIGNIFICANCE


In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking.
CLINICAL TRIAL REGISTRATION NUMBER


KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022']
1638,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995']
1639,32498216,Difensil Immuno Reduces Recurrence and Severity of Tonsillitis in Children: A Randomized Controlled Trial.,"Oral supplements (OS) support the immune system in fighting upper airways infection. This study aimed to analyze the effect of Difensil Immuno (DI) on the recurrence of tonsillitis and fever in children. A multicentric randomized clinical trial was conducted. One-hundred and twenty children with chronic tonsillitis were randomly assigned to group A, B or control. Patients in group A were treated with 10 mL of DI for 90 consecutive days, patients in group B underwent treatment with 15 mL of DI for 45 consecutive days. The following data were collected at baseline (T0), T1 and T2: tonsillitis and fever episodes, tonsillar volume, blood test results. One-way ANOVA was used to analyze within and between variances. Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2. However, T1 variances were more consistent in group A than in group B. All patients in the study groups improved their clinical outcomes. No statistically significant variances were observed in blood parameters both at T1 and T2. Our results suggest that children treated with DI had fewer episodes of tonsillitis and fever and a reduction in their tonsillar volume.",2020,"Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2.","['tonsillitis and fever in children', 'Children', 'One-hundred and twenty children with chronic tonsillitis']","['Difensil Immuno', 'Difensil Immuno (DI', 'Oral supplements (OS']","['episodes of tonsillitis and fever', 'blood parameters', 'T1 and T2: tonsillitis and fever episodes, tonsillar volume, blood test results', 'Recurrence and Severity of Tonsillitis', 'clinical parameters (episode of tonsillitis and fever, tonsillar volume']","[{'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0149517', 'cui_str': 'Chronic tonsillitis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",120.0,0.0380602,"Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2.","[{'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': 'Department of Otolaryngology, University of Perugia, 06129 Perugia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Della Volpe', 'Affiliation': ""Otology and Cochlear Implant Unit, Santobono-Pausilipon Children's Hospital, 80129 Naples, Italy.""}, {'ForeName': 'Fiammetta M', 'Initials': 'FM', 'LastName': 'Korsch', 'Affiliation': ""Otology and Cochlear Implant Unit, Santobono-Pausilipon Children's Hospital, 80129 Naples, Italy.""}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'De Lucia', 'Affiliation': ""Otology and Cochlear Implant Unit, Santobono-Pausilipon Children's Hospital, 80129 Naples, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Sense Organs Department, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Martines', 'Affiliation': 'Biomedicine, Neuroscience and Advanced Diagnostics Department, University of Palermo, 90127 Palermo, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Ricci', 'Affiliation': 'Department of Otolaryngology, University of Perugia, 06129 Perugia, Italy.'}]",Nutrients,['10.3390/nu12061637']
1640,32499312,The Diet of Higher Insulinemic Potential Is Not Associated with Worse Survival in Patients with Stage III Colon Cancer (Alliance).,"BACKGROUND


Hyperinsulinemia is considered to be important in the development of colon cancer, but few studies have investigated the associations of hyperinsulinemia with colon cancer survival via dietary scores.
METHODS


Empirical dietary index for hyperinsulinemia (EDIH) was derived to assess the insulinemic potential of daily diets reflecting the long-term insulin exposure, with higher (more positive) scores indicating higher insulinemic diets. We prospectively estimated the HRs and 95% confidence intervals (CI) to investigate the association of EDIH with disease-free, recurrence-free, and overall survival among patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803).
RESULTS


Of 1,024 patients (median follow-up: 7.3 years), 311 died, 350 had recurrences, and 394 had events for disease-free survival. Compared with patients in the lowest quintile of EDIH, the corresponding HRs of patients in the highest quintile for disease-free survival events, cancer recurrence, and overall mortality were 0.80 (95% CI, 0.56-1.15), 0.76 (95% CI, 0.51-1.11), and 0.77 (95% CI, 0.52-1.14).
CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of patients with stage III colon cancer.
IMPACT


EDIH, as a measure of dietary insulinemic potential, may be associated with colon cancer risk but not survival in patients with late-stage colon cancer.",2020,"CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","['late stage colon cancer patients', 'Patients with Stage III Colon Cancer (Alliance', 'patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803', 'stage III colon cancer patients']",[],"['hazard ratios (HR', 'risk of colon cancer recurrence or mortality', 'EDIH with disease-free, recurrence-free, and overall survival', 'disease-free survival', 'disease-free survival events, cancer recurrence, and overall mortality']","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",,0.343602,"CONCLUSIONS


Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","[{'ForeName': 'En', 'Initials': 'E', 'LastName': 'Cheng', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mullen', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Saltz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Rex B', 'Initials': 'RB', 'LastName': 'Mowat', 'Affiliation': 'Toledo Community Hospital Oncology Program, Toledo, Ohio.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Whittom', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hantel', 'Affiliation': 'Loyola University, Stritch School of Medicine, Naperville, Illinois.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Atienza', 'Affiliation': 'Virginia Oncology Associates, Norfolk, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Messino', 'Affiliation': 'Southeast Cancer Oncology Research Consortium, Mission Hospitals, Asheville, North Carolina.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kindler', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology and Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Epidemiology and Biostatistics and Department of Urology, University of California, San Francisco, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Division of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut. charles.fuchs@yale.edu.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1454']
1641,32503946,Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.,"BACKGROUND


We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.
METHODS


This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.
RESULTS


At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively. The incidence of grade 3/4 treatment-related AEs was 36% in the 10 mg/kg group vs 20% in the 3 mg/kg group, and deaths due to treatment-related AEs occurred in four (1%) and two patients (1%), respectively.
CONCLUSIONS


This 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies.
TRIAL REGISTRATION NUMBER


NCT01515189.",2020,"In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","['patients with advanced melanoma', 'patients with untreated or previously treated unresectable stage III or IV melanoma', 'patients with advanced melanoma who started metastatic treatment with']","['ipilimumab monotherapy', 'ipilimumab']","['OS', 'median OS', 'Overall survival', 'sustained long-term survival', 'median OS of patients with asymptomatic brain metastasis', 'overall survival (OS', 'incidence of grade 3/4 treatment-related AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.585321,"In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","[{'ForeName': 'Paolo Antonio', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Del Vecchio', 'Affiliation': 'Unit of Melanoma Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Center, Poznan Medical University, Poznan, Poland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Medicine, Dermatology Service, Gustave Roussy, Villejuif and Paris-Sud-University, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': ""Hospital Clinic and Institut D'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Université de Paris, INSERM, Dermatology and CIC, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Inge Marie', 'Initials': 'IM', 'LastName': 'Svane', 'Affiliation': 'Center for Cancer Immune Therapy, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Skłodowska-Curie Institute-Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': ""Clinique de Dermatologie, Unité d'Onco-Dermatologie, INSERM U1189, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.""}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Melanoma Center, The Angeles Clinic and Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreno', 'Affiliation': 'Department of Oncodermatology, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, Eberhard Karls Universitat Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancers Department, Aix-Marseille University, APHM, Marseille, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'Department of Oncodermatology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoeller', 'Affiliation': 'Division of General Dermatology and Dermato-Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Unit of Medical Oncology, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'Department of Dermatology, University Hospital Centre Reims, Reims, Champagne-Ardenne, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Operative Dermatology and Dermato-Oncology, Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Department of Oncology, Wojewodzkie Centrum Oncologii, Gdańsk, Poland.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Burcin', 'Initials': 'B', 'LastName': 'Simsek', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Instituto Toscano Tumori, Siena, Italy.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000391']
1642,32500209,Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.,"RATIONALE


Posttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual's health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD.
OBJECTIVES


To examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD.
METHODS


Participants received two to three active doses of MDMA (75-125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire.
RESULTS


There was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation.
CONCLUSIONS


PTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.",2020,The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%).,"['participants with chronic PTSD', 'PTSD', 'Participants', 'Posttraumatic stress disorder (PTSD']","['open-label psychotherapy sessions with additional non-drug therapy sessions', '3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy', 'MDMA', 'MDMA-assisted psychotherapy']","['CAPS-IV scores', 'PTSD symptoms', 'CAPS-IV total severity scores', 'Clinician-Administered PTSD Scale for DSM IV']","[{'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",,0.111743,The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%).,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jerome', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA. Ilsa@mapsbcorp.com.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Feduccia', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Julie B', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Stanford School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Emerson', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mithoefer', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Doblin', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05548-2']
1643,32500212,Subjective features of the psilocybin experience that may account for its self-administration by humans: a double-blind comparison of psilocybin and dextromethorphan.,"RATIONALE


Although both psilocybin and dextromethorphan (DXM) produce psychedelic-like subjective effects, rates of non-medical use of psilocybin are consistently greater than DXM.
OBJECTIVE


New data are presented from a study of psilocybin and DXM relevant to understanding the features of psilocybin subjective effects that may account for its higher rates of non-medical use.
METHODS


Single, acute oral doses of psilocybin (10, 20, 30 mg/70 kg), DXM (400 mg/70 kg), and placebo were administered under double-blind conditions to 20 healthy participants with histories of hallucinogen use.
RESULTS


High doses of both drugs produced similar time courses and increases in participant ratings of peak overall drug effect strength. Nine subjective effect domains are proposed to be related to the reinforcing effects of psilocybin: liking, visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience. For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM. These differences were consistent with two measures of desire to take the drug condition again.
CONCLUSIONS


This analysis provides new information about domains of psilocybin subjective effects proposed to be related to its reinforcing effects (alternatively described as the ""motivation"" to use). Observed differences on these domains between psilocybin and DXM are consistent with the relative rates of non-medical use of psilocybin and DXM.",2020,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.",['20 healthy participants with histories of hallucinogen use'],"['psilocybin and dextromethorphan', 'psilocybin and dextromethorphan (DXM', 'psilocybin', 'DXM', 'placebo']","['visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience', 'participant ratings of peak overall drug effect strength', 'DXM']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004898', 'cui_str': 'Beauty'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}]",20.0,0.150916,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Carbonaro', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA. rgriff@jhmi.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05533-9']
1644,32502908,Effects of 1 mA and 2 mA transcranial direct current stimulation on working memory performance in healthy participants.,"Anodal transcranial current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) has been shown to enhance working memory (WM) in neuropsychiatric patients. In healthy populations, however, tDCS obtains inconclusive results, mostly due to heterogeneous study and stimulation protocols. Here, we approached these issues by investigating effects of tDCS intensity on simultaneous WM performance with three cognitive loads by directly comparing findings of two double-blind, cross-over, sham-controlled experiments. TDCS was administrated to the left DLPFC at intensity of 1 mA (Experiment 1) or 2 mA (Experiment 2), while participants completed a verbal n-back paradigm (1-, 2-, 3-back). Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load. The present study suggests that cognitive load rather than tDCS intensity could be a decisive factor for effects on WM. Moreover, it emphasizes the need of thorough investigation on study parameters to develop more efficient stimulation protocols.",2020,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","['healthy participants', 'neuropsychiatric patients']","['1\xa0mA and 2\xa0mA transcranial direct current stimulation', 'TDCS', 'Anodal transcranial current stimulation (tDCS']",['working memory performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0450811,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany. Electronic address: Irina.papazova@med.uni-muenchen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Henning', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schwippel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, BKH Augsburg, Medical Faculty, University of Augsburg, Germany.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102959']
1645,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES


Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
METHODS


Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity.
RESULTS


763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
CONCLUSION


This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027']
1646,32496902,Impact of Intrathecal Triple Therapy Versus Intrathecal Methotrexate on Disease-Free Survival for High-Risk B-Lymphoblastic Leukemia: Children's Oncology Group Study AALL1131.,"PURPOSE


The high-risk stratum of Children's Oncology Group Study AALL1131 was designed to test the hypothesis that postinduction CNS prophylaxis with intrathecal triple therapy (ITT) including methotrexate, hydrocortisone, and cytarabine would improve the postinduction 5-year disease-free survival (DFS) compared with intrathecal methotrexate (IT MTX), when given on a modified augmented Berlin-Frankfurt-Münster backbone.
PATIENTS AND METHODS


Children with newly diagnosed National Cancer Institute (NCI) high-risk B-cell acute lymphoblastic leukemia (HR B-ALL) or NCI standard-risk B-ALL with defined minimal residual disease thresholds during induction were randomly assigned to receive postinduction IT MTX or ITT. Patients with CNS3-status disease were not eligible. Postinduction IT therapy was given for a total of 21 to 26 doses. Neurocognitive assessments were performed during therapy and during 1 year off therapy.
RESULTS


Random assignment was closed to accrual in March 2018 after a futility boundary had been crossed, concluding that ITT could not be shown to be superior to IT MTX. The 5-year postinduction DFS and overall survival rates (± SE) of children randomly assigned to IT MTX versus ITT were 93.2% ± 2.1%  v  90.6% ± 2.3% ( P  = .85), and 96.3% ± 1.5%  v  96.7% ± 1.4% ( P  = .77), respectively. There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT. There were no significant differences in neurocognitive outcomes for patients receiving IT MTX compared with ITT.
CONCLUSION


Postinduction CNS prophylaxis with ITT did not improve 5-year DFS for children with HR B-ALL. The standard of care for CNS prophylaxis for children with B-ALL and no overt CNS involvement remains IT MTX.",2020,"There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT.","['children with B-ALL and no overt CNS involvement remains IT MTX', 'Patients with CNS3-status disease', 'Children with newly diagnosed National Cancer Institute (NCI) high-risk B-cell acute lymphoblastic leukemia (HR B-ALL) or NCI standard-risk B-ALL with defined minimal residual disease thresholds during induction']","['Intrathecal Methotrexate', 'postinduction IT MTX or ITT', 'IT MTX', 'Intrathecal Triple Therapy', 'intrathecal triple therapy (ITT) including methotrexate, hydrocortisone, and cytarabine', 'intrathecal methotrexate (IT MTX']","['cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities', 'neurocognitive outcomes', '5-year DFS', 'postinduction 5-year disease-free survival (DFS', '5-year postinduction DFS and overall survival rates (± SE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0686377', 'cui_str': 'Secondary malignant neoplasm of central nervous system'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0503645,"There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT.","[{'ForeName': 'Wanda L', 'Initials': 'WL', 'LastName': 'Salzer', 'Affiliation': 'Uniformed Services University, Bethesda, MD.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burke', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Kristina K', 'Initials': 'KK', 'LastName': 'Hardy', 'Affiliation': ""Children's National Medical Center, Washington, DC.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kairalla', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Gore', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Hilden', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Department of Pediatrics, Maine Children's Cancer Program, Scarborough, ME.""}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Zweidler-McKay', 'Affiliation': 'ImmunoGen, Inc, Waltham, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, The Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02892']
1647,32504895,Patterns of daytime physical activity in patients with chronic fatigue syndrome.,"OBJECTIVES


To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type.
METHODS


579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group.
RESULTS


124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
CONCLUSION


We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication.",2020,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","['patients with chronic fatigue syndrome', '579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy', 'patients with chronic fatigue syndrome (CFS']",[],"['sleep disturbance', 'daytime physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],"[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",641.0,0.0298142,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beynon', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, Weston Education Centre, London, UK. Electronic address: Trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'White', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110154']
1648,32506135,Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study.,"CONTEXT


Although dietary potassium and sodium intake may influence calcium-phosphate metabolism and bone health, the effects on bone mineral parameters, including fibroblast growth factor 23 (FGF23), are unclear.
OBJECTIVE


Here, we investigated the effects of potassium or sodium supplementation on bone mineral parameters.
DESIGN, SETTING, PARTICIPANTS


We performed a post hoc analysis of a dietary controlled randomized, blinded, placebo-controlled crossover trial. Prehypertensive individuals not using antihypertensive medication (n = 36) received capsules containing potassium chloride (3 g/d), sodium chloride (3 g/d), or placebo. Linear mixed-effect models were used to estimate treatment effects.
RESULTS


Potassium supplementation increased plasma phosphate (from 1.10 ± 0.19 to 1.15 ± 0.19 mmol/L, P = 0.004), in line with an increase in tubular maximum of phosphate reabsorption (from 0.93 ± 0.21 to 1.01 ± 0.20 mmol/L, P < 0.001). FGF23 decreased (114.3 [96.8-135.0] to 108.5 [93.5-125.9] RU/mL, P = 0.01), without change in parathyroid hormone and 25-hydroxy vitamin D3. Fractional calcium excretion decreased (from 1.25 ± 0.50 to 1.11 ± 0.46 %, P = 0.03) without change in plasma calcium. Sodium supplementation decreased both plasma phosphate (from 1.10 ± 0.19 to 1.06 ± 0.21 mmol/L, P = 0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P = 0.02). Urinary and fractional calcium excretion increased (from 4.28 ± 1.91 to 5.45 ± 2.51 mmol/24 hours, P < 0.001, and from 1.25 ± 0.50 to 1.44 ± 0.54 %, P = 0.004, respectively).
CONCLUSIONS


Potassium supplementation led to a decrease in FGF23, which was accompanied by increase in plasma phosphate and decreased calcium excretion. Sodium supplementation reduced FGF23, but this was accompanied by decrease in phosphate and increase in fractional calcium excretion. Our results indicate distinct effects of potassium and sodium intake on bone mineral parameters, including FGF23.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01575041.",2020,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).",['hypertensive individuals not using antihypertensive medication (n=36) received'],"['Potassium or Sodium Supplementation', 'sodium chloride', 'capsules containing potassium chloride', 'Potassium supplementation', 'dietary potassium and sodium intake', 'potassium and sodium intake', 'potassium or sodium supplementation', 'Sodium supplementation', 'placebo']","['parathyroid hormone and 25(OH)-vitamin D3', 'Fractional calcium excretion', 'bone mineral parameters, including FGF23', 'Mineral Homeostasis', 'Urinary and fractional calcium excretion', 'plasma calcium', 'bone mineral parameters', 'plasma phosphate', 'FGF23', 'plasma phosphate and decreased calcium excretion', 'tubular maximum of phosphate reabsorption', 'fractional calcium excretion']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}, {'cui': 'C0162800', 'cui_str': 'Dietary Potassium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1272114', 'cui_str': 'Plasma calcium level'}, {'cui': 'C0858147', 'cui_str': 'Plasma phosphate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}]",,0.11207,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).","[{'ForeName': 'Jelmer K', 'Initials': 'JK', 'LastName': 'Humalda', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Stanley M H', 'Initials': 'SMH', 'LastName': 'Yeung', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Geleijnse', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, HB Wageningen, the Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Gijsbers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, HB Wageningen, the Netherlands.'}, {'ForeName': 'Ineke J', 'Initials': 'IJ', 'LastName': 'Riphagen', 'Affiliation': 'Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, CA Rotterdam, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, RC Leiden, the Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, DD Amsterdam Zuidoost, the Netherlands.'}, {'ForeName': 'Gerjan', 'Initials': 'G', 'LastName': 'Navis', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa359']
1649,32498328,The Effect of Low-Carbohydrate Diet on Macrovascular and Microvascular Endothelial Function is Not Affected by the Provision of Caloric Restriction in Women with Obesity: A Randomized Study.,"Obesity impairs both macro- and microvascular endothelial function due to decreased bioavailability of nitric oxide. Current evidence on the effect of low-carbohydrate (LC) diet on endothelial function is conflicting and confounded by the provision of caloric restriction (CR). We tested the hypothesis that LC without CR diet, but not LC with CR diet, would improve macro- and microvascular endothelial function in women with obesity. Twenty-one healthy women with obesity (age: 33 ± 2 years, body mass index: 33.0 ± 0.6 kg/m 2 ; mean ± SEM) were randomly assigned to receive either a LC diet (~10% carbohydrate calories) with CR ( n  = 12; 500 calorie/day deficit) or a LC diet without CR ( n  = 9) and completed the 6-week diet intervention. After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%,  p  = 0.7). On the other hand, following the LC diet intervention, regardless of CR, blocking nitric oxide production decreased microvascular endothelial function, measured by arteriolar flow-induced dilation ( p  ≤ 0.02 for both diets) and the magnitude was more than baseline ( p  ≤ 0.04). These data suggest improved NO contributions following the intervention. In conclusion, a 6-week LC diet, regardless of CR, may improve microvascular, but not macrovascular endothelial function, via increasing bioavailability of nitric oxide in women with obesity.",2020,"After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%,  p  = 0.7).","['women with obesity', 'Women with Obesity', 'Twenty-one healthy women with obesity (age: 33 ± 2 years, body mass index: 33.0 ± 0.6 kg/m 2 ; mean ± SEM']","['LC diet without CR ( n  = 9) and completed the 6-week diet intervention', 'LC with CR diet', 'Low-Carbohydrate Diet', 'low-carbohydrate (LC) diet', 'LC diet (~10% carbohydrate calories) with CR']","['brachial artery flow-mediated dilation', 'microvascular endothelial function', 'Macrovascular and Microvascular Endothelial Function', 'macro- and microvascular endothelial function', 'macrovascular endothelial function', 'arteriolar flow-induced dilation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",21.0,0.0299143,"After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%,  p  = 0.7).","[{'ForeName': 'Chueh-Lung', 'Initials': 'CL', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ranieri', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Szczurek', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Assem M', 'Initials': 'AM', 'LastName': 'Ellythy', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elokda', 'Affiliation': 'Department of Rehabilitation Sciences, Florida Gulf Coast University, Fort Myers, FL 33965, USA.'}, {'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Nutrients,['10.3390/nu12061649']
1650,32503294,A Mixed Methods Evaluation of a Randomized Control Trial to Evaluate the Effectiveness of the Pure Prairie Living Program in Type 2 Diabetes Participants.,"The primary objective of this randomized control trial was to evaluate the effectiveness of the Pure Prairie Living Program (PPLP) in a primary care setting. Adults with type 2 diabetes were randomized into intervention (PPLP,  n  = 25) and wait-listed controls (CON,  n  = 24). The PPLP group participated in education sessions. The intervention yielded no significant within-group changes in HbA1c at three-month (-0.04 (-0.27 to 0.17) and -0.15 (-0.38 to 0.08)) or six-month (-0.09 (-0.41 to 0.22) and 0.06 (-0.26 to 0.38)) follow ups in either CON or PPLP groups, respectively. Dietary adherence scores improved in the PPLP group ( p  < 0.05) at three and six months but were not different in the between-group comparison. No changes in diabetes self-efficacy scores were detected. In the qualitative analysis, participants described the program as clear and easy to understand. Knowledge acquired influenced their everyday decision making but participants faced barriers that prevented them from fully applying what they learned. Healthcare professionals enjoyed delivering the program but described the ""back-stage"" workload as detrimental. In conclusion, while some positive effects of the PPLP intervention were observed, they were not comparable to those previously attained by our group in an academic setting or to what the guidelines recommend, which reflects the challenge of translating lifestyle intervention to real-world settings.",2020,Dietary adherence scores improved in the PPLP group ( p  < 0.05) at three and six months but were not different in the between-group comparison.,"['Type 2 Diabetes Participants', 'Adults with type 2 diabetes']","['Pure Prairie Living Program (PPLP', 'PPLP', 'Pure Prairie Living Program']","['Dietary adherence scores', 'diabetes self-efficacy scores']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0442534', 'cui_str': 'Prairie'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0301551,Dietary adherence scores improved in the PPLP group ( p  < 0.05) at three and six months but were not different in the between-group comparison.,"[{'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Archundia-Herrera', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, 6-002 Li Ka Shing Centre for Health Innovation Research, Edmonton, AB T6G 2E1, Canada.'}, {'ForeName': 'Fatheema B', 'Initials': 'FB', 'LastName': 'Subhan', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, AB T6G 2T4, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sakowsky', 'Affiliation': 'Sherwood Park Primary Care Network, 150 Broadway Crescent, Suite 108, Sherwood Park, AB T8H 0V3, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Watkins', 'Affiliation': 'Sherwood Park Primary Care Network, 150 Broadway Crescent, Suite 108, Sherwood Park, AB T8H 0V3, Canada.'}, {'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Chan', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, 6-002 Li Ka Shing Centre for Health Innovation Research, Edmonton, AB T6G 2E1, Canada.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020153']
1651,32506233,Does acute stress influence the Pavlovian-to-instrumental transfer effect? Implications for substance use disorders.,"RATIONAL


The ability of conditioned stimuli to affect instrumental responding is a robust finding from animal as well as human research and is assumed as a key factor regarding the development and maintenance of addictive behaviour.
OBJECTIVES


While it is well known that stress is an important factor for relapse after treatment, little is known about the impact of stress on conditioned substance-associated stimuli and their influence on instrumental responding.
METHODS


We administered in the present study a Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points in a token economy to light to moderate smokers who also indicated to like eating chocolate. After completion of the first two phases of the PIT paradigm (i.e. Pavlovian training and instrumental trainings), participants were randomly allocated to the socially evaluated cold pressor test or a control condition before the final phase of the PIT paradigm, the transfer phase, was administered.
RESULTS


The presentation of a smoking-related stimulus enhanced instrumental responding for a smoking-related reward (i.e. 'smoking-PIT' effect) and presentation of a chocolate-related stimulus for a chocolate-related reward (i.e. 'chocolate-PIT' effect) in participants aware of the experimental contingencies as indicated by expectancy ratings. However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
CONCLUSIONS


The established role of stress in addiction appears not to be driven by an augmenting effect on the ability of drug stimuli to promote drug-seeking.",2020,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
",[],"['PIT paradigm (i.e. Pavlovian training and instrumental trainings', 'socially evaluated cold pressor test', 'Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points']","['acute stress', 'tobacco choice']",[],"[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",,0.0217592,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steins-Loeber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany. sabine.steins-loeber@uni-bamberg.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lörsch', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'van der Velde', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of General Psychology: Cognition, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Duka', 'Affiliation': 'Sussex Addiction Research and Intervention Centre, School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Ruhr University Bochum, Bochum, Germany.'}]",Psychopharmacology,['10.1007/s00213-020-05534-8']
1652,32506275,"Preoperative meloxicam versus postoperative meloxicam for pain control, patients' satisfaction and function recovery in hip osteoarthritis patients who receive total hip arthroplasty: a randomized, controlled study.","This study aimed to compare the analgesic effect, patients' satisfaction, tolerance and hip-joint function recovery by preoperative meloxicam versus postoperative meloxicam in treating hip osteoarthritis (OA) patients receiving total hip arthroplasty (THA). 132 hip OA patients who underwent THA surgery were allocated into postoperative analgesia (POST) and preoperative analgesia (PRE) groups at a 1:1 ratio. In the PRE group, patients took meloxicam 15 mg at 24 h pre-operation, 7.5 mg at 4 h, 24 h, 48 h and 72 h post-operation; in the POST group, patients received meloxicam 15 mg at 4 h post-operation, then 7.5 mg at 24 h, 48 h and 72 h post-operation. Furthermore, postoperative pain, consumption of patient-controlled analgesia (PCA), overall satisfaction and adverse events were evaluated within 96 h post-operation; meanwhile, Harris hip score was assessed within 6 months post-operation. Pain VAS at rest at 6 h, 12 h, 24 h, and pain VAS at passive movement at 6 h, 12 h were decreased in PRE group compared to POST group. In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group. Additionally, overall satisfaction in PRE group was higher at 24 h, 48 h and 72 h compared to POST group. While Harris hip score was of no difference between POST group and PRE group at M3 or M6. Besides, no difference in adverse events incidence was found between the two groups. In conclusion, preoperative meloxicam achieves better efficacy and similar tolerance compared to postoperative meloxicam in hip OA patients post THA.",2020,"In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group.","['hip osteoarthritis patients who receive total hip arthroplasty', '132 hip OA patients who underwent THA surgery', 'treating hip osteoarthritis (OA) patients receiving total hip arthroplasty (THA']","['postoperative analgesia (POST) and preoperative analgesia (PRE', 'meloxicam 15\xa0mg at 4\xa0h post-operation', 'meloxicam', 'Preoperative meloxicam versus postoperative meloxicam', 'meloxicam versus postoperative meloxicam']","['overall satisfaction', 'total consumption of PCA', 'Pain VAS', 'efficacy and similar tolerance', 'adverse events incidence', 'pain VAS at passive movement', ""analgesic effect, patients' satisfaction, tolerance and hip-joint function recovery"", 'Furthermore, postoperative pain, consumption of patient-controlled analgesia (PCA), overall satisfaction and adverse events']","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1128682', 'cui_str': 'meloxicam 15 MG'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",132.0,0.0274409,"In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group.","[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China. haodunye9398649@163.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}]",Inflammopharmacology,['10.1007/s10787-020-00718-2']
1653,32512272,Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis.,"INTRODUCTION


Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective.
METHODS


A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups.
RESULTS


Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of $138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of $150,000 per QALY CONCLUSION: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies.",2020,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","['patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy', 'patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial', 'stage III non-small-cell lung cancer']","['durvalumab consolidation therapy', 'durvalumab', 'Durvalumab vs placebo consolidation therapy after chemoradiotherapy', 'placebo']","['total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'mean lifetime costs and effectiveness', 'OS rates', 'cost effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0947434,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, PR China. Electronic address: gongyouling@hotmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.011']
1654,32497906,Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock: Subanalysis from the CULPRIT-SHOCK trial.,"BACKGROUND


The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear.
METHODS


This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes.
RESULTS


Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively).
CONCLUSIONS


In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.",2020,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"['patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock', 'patients undergoing', 'patients presenting with MI and multivessel disease complicated by CS']","['Radial versus femoral artery access', 'percutaneous coronary intervention (PCI', 'transradial artery access (TRA', 'percutaneous coronary artery intervention', 'transfemoral artery access (TFA']","['TRA and TFA', '30-day rate of death', '30-day rate of RRT', '30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke', 'death or RRT and death with TRA', '30-day rate of death or RRT', 'composite of death or renal replacement therapy (RRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",673.0,0.38324,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': 'Statistician unit, StatEthic, Levallois-Perret, France.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung and Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.014']
1655,32504207,Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).,"BACKGROUND


Patients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.
METHODS


In this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. Patients' postoperative courses were followed for 1 year after the index operation. Effectiveness and safety outcomes were compared at a level of significance of 5% between the two techniques.
RESULTS


A total of 100 out of 131 patients (76.3%) were evenly randomised to the small stitches and large stitches groups. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334). The overall comprehensive complication index was 14.4 ± 15.5 in the small stitches group and 19.9 ± 23.4 in the large stitches group (p = 0.168). Specifically, rates of surgical site infection (small stitches 30.0% versus large stitches 36.0%; p = 0.524) and burst abdomen (small stitches 4.0% versus large stitches 0.0%; p = 0.495) did not differ. After 1 year, incisional hernia rate was 7.5% in the small stitches group and 10.0% in the large stitches group (p > 0.999).
DISCUSSION


Both abdominal wall closure techniques investigated in this trial were feasible in relaparotomy patients. This exploratory trial revealed no noticeable difference in the effectiveness or safety of the small stitches technique with Monomax® 2-0 versus the large stitches technique with PDS II® 1 loop. Therefore, surgeons should stay with their preferred suture technique in relaparotomy patients.
TRIAL REGISTRATION


Deutsches Register Klinischer Studien ( www.germanctr.de ): DRKS00013001.",2020,The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334).,"['patients undergoing relaparotomy (ReLap study', 'patients scheduled for elective relaparotomy', 'relaparotomy patients', 'A total of 100 out of 131 patients (76.3', 'patients undergoing relaparotomy']","['abdominal wall closure techniques', 'abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop']","['burst abdomen', 'Effectiveness and safety outcomes', 'rates of surgical site infection', 'incisional hernia rate', 'overall comprehensive complication index', 'time for abdominal wall closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0023035', 'cui_str': 'Suture of abdominal wall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0085242', 'cui_str': 'Polydioxanone'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]","[{'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023035', 'cui_str': 'Suture of abdominal wall'}]",131.0,0.176231,The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334).,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. pascal.probst@med.uni-heidelberg.de.'}, {'ForeName': 'Dinh Thien-An', 'Initials': 'DT', 'LastName': 'Tran', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Harnoss', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heger', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Alina S', 'Initials': 'AS', 'LastName': 'Ritter', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Doerr-Harim', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01903-1']
1656,32505019,"Indentation marks, skin temperature and comfort of two cervical collars: A single-blinded randomized controlled trial in healthy volunteers.","BACKGROUND


Collar-related pressure ulcers (CRPU) are a problem in trauma patients with a suspicion of cervical cord injury patients. Indentation marks (IM), skin temperature (T sk ) and comfort could play a role in the development of CRPU. Two comparable cervical collars are the Stifneck® and Philadelphia®. However, the differences between them remain unclear.
AIM


To determine and compare occurrence and severity of IM, T sk  and comfort of the Stifneck® and Philadelphia® in immobilized healthy adults.
METHODS


This single-blinded randomized controlled trial compared two groups of immobilized participants in supine position for 20 min.
RESULTS


All participants (n = 60) generated IM in at least one location in the observed area. Total occurrence was higher in the Stifneck®-group (n = 95 versus n = 69; p = .002). T sk  increased significantly with 1.0  °C in the Stifneck®-group and 1.3 °C in the Philadelphia®-group (p = .024). Comfort was rated 3 on a scale of 5 (p = .506).
CONCLUSION


The occurrence of IM in both groups was high. In comparison to the Stifneck®, fewer and less severe IM were observed from the Philadelphia®. The T sk  increased significantly with both collars; however, no clinical difference in increase of T sk  between them was found. The results emphasize the need for a better design of cervical collars regarding CRPU.",2020,Total occurrence was higher in the Stifneck®-group,"['immobilized healthy adults', 'trauma patients with a suspicion of cervical cord injury patients', 'healthy volunteers', 'participants in supine position for 20\xa0min']","['immobilized', 'Collar-related pressure ulcers (CRPU']","['Indentation marks (IM), skin temperature (T sk ) and comfort', 'T sk', 'severe IM', 'Total occurrence', 'Indentation marks, skin temperature and comfort of two cervical collars']","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0457846', 'cui_str': 'Segment of cervical spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}]",,0.152707,Total occurrence was higher in the Stifneck®-group,"[{'ForeName': 'J P L', 'Initials': 'JPL', 'LastName': 'Leenen', 'Affiliation': 'Department of Surgery, Isala, Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands. Electronic address: j.p.l.leenen@isala.nl.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Ham', 'Affiliation': 'Emergency Department, University Medical Center Utrecht, University of Applied Science, Institute of Nursing Studies, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: w.h.ham@umcutrecht.nl.'}, {'ForeName': 'L P H', 'Initials': 'LPH', 'LastName': 'Leenen', 'Affiliation': 'Department of Traumatology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: l.p.h.leenen@umcutrecht.nl.'}]",International emergency nursing,['10.1016/j.ienj.2020.100878']
1657,32508297,Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial - Corrigendum.,,2020,,['women with polycystic ovary syndrome'],"['synbiotic supplementation', 'placebo']",['metabolic parameters and apelin'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}]",,0.796448,,"[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karimi', 'Affiliation': ''}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': ''}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Shirzad', 'Affiliation': ''}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': ''}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Hossein-Boroujerdi', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Javad Hosseinzadeh-Attar', 'Affiliation': ''}]",The British journal of nutrition,['10.1017/S0007114520001488']
1658,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177']
1659,32505660,Frontal-midline theta frequency and probabilistic learning: A transcranial alternating current stimulation study.,"Probabilistic learning is a fundamental cognitive ability that extracts and represents regularities of our environment enabling predictive processing during perception and acquisition of perceptual, motor, cognitive, and social skills. Previous studies show competition between neural networks related to executive function/working memory vs. probabilistic learning. Theta synchronization has been associated with the former while desynchronization with the latter in correlational studies. In the present paper our aim was to test causal relationship between fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation. We hypothesize that theta synchronization disrupts probabilistic learning performance by modulating the competitive relationship. Twenty-six young adults performed the Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning in two sessions that took place one week apart. Stimulation was applied in a double-blind cross-over within-subject design with an active theta tACS and a sham stimulation in a counter-balanced order between participants. Sinusoidal current was administered with 1 mA peak-to-peak intensity throughout the task (approximately 20 min) for the active stimulation and 30 s for the sham. We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation. To influence probabilistic learning, we suggest applying higher current intensity and stimulation parameters more precisely aligned to endogenous brain activity for future studies.",2020,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,['Twenty-six young adults'],"['fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation', 'probabilistic learning', 'fronto-parietal midline theta tACS', 'Probabilistic learning', 'Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning']",['probabilistic learning performance'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",26.0,0.103353,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,"[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Zavecz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Horváth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Solymosi', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janacsek', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Centre of Thinking and Learning, Institute for Lifecourse Development, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Dezso', 'Initials': 'D', 'LastName': 'Nemeth', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Lyon Neuroscience Research Center (CRNL), INSERM, CNRS, Université Claude Bernard Lyon 1, Lyon, France. Electronic address: dezso.nemeth@univ-lyon1.fr.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112733']
1660,32511900,Effects of Vitamin D on Apoptosis and Quality of Sperm in Asthenozoospermia.,"OBJECTIVE


Vitamin D receptor (VDR) is expressed in human spermatozoa. However, the role of vitamin D (VD) in human male reproduction has not yet been clarified. In this study, effects of VD on sperm parameters and its apoptosis in asthenozoospermic and healthy men were evaluated.
METHODS


The study was carried out on discharged semen samples of 80 asthenozoospermic and healthy men. The samples were divided into control and experimental groups (received 20 µMol of VD). This study assessed sperm motility using the Makler chamber, their morphology by Diff quick, apoptosis and necrosis by Annexin-V and TUNEL assays, and their chromatin integrity was assessed by Aniline blue and Toluidine blue staining, according to WHO guidelines.
RESULTS


The results revealed that: 1) the total number of motile sperms was increased by VD in both groups, but it was only significant in the asthenozoospermia group. 2) The progressive motility was increased with significant difference in both groups.3) Morphology of sperm did not show any changes due to VD in any of the groups. 4) Early apoptosis and necrosis of sperms were reduced in both groups, but the results of late apoptosis showed no statistical difference in these groups. 5) The percentage of positive toluidine blue was significantly decreased after using VD in the asthenozoospermia group.
CONCLUSION


VD could improve motility, early apoptosis, and sperm necrosis, especially in asthenozoospermic men and it could be used for therapeutic opportunities.",2020,"Early apoptosis and necrosis of sperms were reduced in both groups, but the results of late apoptosis showed no statistical difference in these groups.","['asthenozoospermic and healthy men', 'discharged semen samples of 80 asthenozoospermic and healthy men']","['Vitamin D receptor (VDR', 'Vitamin D', 'vitamin D (VD']","['percentage of positive toluidine blue', 'progressive motility', 'motility, early apoptosis, and sperm necrosis', 'Early apoptosis and necrosis of sperms', 'total number of motile sperms', 'Apoptosis and Quality of Sperm in Asthenozoospermia']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444176', 'cui_str': 'Seminal fluid specimen'}]","[{'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}]",,0.0152186,"Early apoptosis and necrosis of sperms were reduced in both groups, but the results of late apoptosis showed no statistical difference in these groups.","[{'ForeName': 'Mahin Taheri', 'Initials': 'MT', 'LastName': 'Moghadam', 'Affiliation': 'Cellular and Molecular Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ghazal', 'Initials': 'G', 'LastName': 'Hosseini', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences,Ahvaz, Iran.'}, {'ForeName': 'Forouzan', 'Initials': 'F', 'LastName': 'Absalan', 'Affiliation': 'Department of anatomical sciences, Abadan School of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Mahmoud Hashemi', 'Initials': 'MH', 'LastName': 'Tabar', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences,Ahvaz, Iran.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Nikbakht', 'Affiliation': 'Fertility, Infertility and Perinatology Center, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20200009']
1661,32512710,"Effect of Porcine Placenta Extract Supplement on Skin Condition in Healthy Adult Women: A Randomized, Double-Blind Placebo-Controlled Study.","Placenta extract has been used as a component of ointments for skin dryness and beautification. However, little is known about the effect of oral intake of placenta extract on skin condition. The current study aimed to clinically explore the effect of oral intake of porcine placenta extract on human skin quality. A randomized controlled double-blind trial was performed on healthy women aged 40-59 years (n = 20), who were randomly assigned to receive either placebo or 200 mg of porcine placenta extract once daily for 4 weeks from 28 January 2019 to 25 February 2019. Skin quality parameters and the Simplified Menopausal Index (SMI) were assessed at baseline and after 4 weeks. After 4 weeks, three parameters of skin quality were significantly improved in the porcine placenta group compared with the placebo group. These results suggest that porcine placenta extract can be used as a health food ingredient to maintain humans' skin condition in the dry winter season.",2020,"After 4 weeks, three parameters of skin quality were significantly improved in the porcine placenta group compared with the placebo group.","['healthy women aged 40-59 years (n = 20', 'Healthy Adult Women']","['Placebo', 'placebo or 200 mg of porcine placenta extract', 'Porcine Placenta Extract Supplement', 'porcine placenta extract', 'Placenta extract', 'placebo']","['human skin quality', 'Skin quality parameters and the Simplified Menopausal Index (SMI', 'Skin Condition', 'skin quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]",,0.422736,"After 4 weeks, three parameters of skin quality were significantly improved in the porcine placenta group compared with the placebo group.","[{'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Nagae', 'Affiliation': 'Faculty of Agriculture, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Nagata', 'Affiliation': 'Faculty of Agriculture, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Healthcare Business Unit, Kasyu Industries Co., Ltd., 2-5-3 Minami-Futajima, Wakamatsu-ku, Kitakyusyu, Fukuoka 808-0109, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yamakawa', 'Affiliation': 'Healthcare Business Unit, Kasyu Industries Co., Ltd., 2-5-3 Minami-Futajima, Wakamatsu-ku, Kitakyusyu, Fukuoka 808-0109, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Matsuki', 'Affiliation': 'Healthcare Business Unit, Kasyu Industries Co., Ltd., 2-5-3 Minami-Futajima, Wakamatsu-ku, Kitakyusyu, Fukuoka 808-0109, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ohnuki', 'Affiliation': 'Department of Biological and Environmental Chemistry, Kinki University Kyushu, Kayanomori, Izuka, Fukuoka 820-8555, Japan.'}, {'ForeName': 'Kuniyoshi', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Faculty of Agriculture, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan.'}]",Nutrients,['10.3390/nu12061671']
1662,32512752,The Effect of Three Mediterranean Diets on Remnant Cholesterol and Non-Alcoholic Fatty Liver Disease: A Secondary Analysis.,"BACKGROUND


Elevated fasting remnant cholesterol (REM-C) levels have been associated with an increased cardiovascular risk in patients with metabolic syndrome (Mets) and Non-Alcoholic Fatty Liver Disease (NAFLD). We aimed to estimate the effect of different diets on REM-C levels in patients with MetS, as well as the association between NAFLD and REM-C.
METHODS


This is a secondary analysis of the MEDIDIET study, a parallel-arm Randomized Clinical Trial (RCT). We examined 237 people with MetS who underwent Liver Ultrasound (LUS) to assess the NAFLD score at baseline, 3-, and 6-months follow-up. Subjects were randomly assigned to the Mediterranean diet (MD), Low Glycemic Index diet (LGID), or Low Glycemic Index Mediterranean diet (LGIMD). REM-C was calculated as [total cholesterol-low density lipoprotein cholesterol (LDL-C)-high density lipoprotein cholesterol (HDL-C)].
RESULTS


REM-C levels were higher in subjects with moderate or severe NAFLD than in mild or absent ones. All diets had a direct effect in lowering the levels of REM-C after 3 and 6 months of intervention. In adherents subjects, this effect was stronger among LGIMD as compared to the control group. There was also a significant increase in REM-C levels among Severe NAFLD subjects at 3 months and a decrease at 6 months.
CONCLUSIONS


fasting REM-C level is independently associated with the grade of severity of NAFLD. LGIMD adherence directly reduced the fasting REM-C in patients with MetS.",2020,"There was also a significant increase in REM-C levels among Severe NAFLD subjects at 3 months and a decrease at 6 months.
","['237 people with MetS who underwent', 'Remnant Cholesterol and Non-Alcoholic Fatty Liver Disease', 'patients with metabolic syndrome (Mets) and Non-Alcoholic Fatty Liver Disease (NAFLD', 'patients with MetS']","['Liver Ultrasound (LUS', 'Mediterranean diet (MD), Low Glycemic Index diet (LGID), or Low Glycemic Index Mediterranean diet (LGIMD', 'Three Mediterranean Diets']","['total cholesterol-low density lipoprotein cholesterol (LDL-C)-high density lipoprotein cholesterol (HDL-C', 'LGIMD adherence', 'REM-C levels', 'NAFLD score', 'levels of REM-C', 'fasting REM-C']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0412534', 'cui_str': 'Ultrasonography of liver'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",237.0,0.0442918,"There was also a significant increase in REM-C levels among Severe NAFLD subjects at 3 months and a decrease at 6 months.
","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Campanella', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Palma A', 'Initials': 'PA', 'LastName': 'Iacovazzi', 'Affiliation': 'Department of Clinical Pathology, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Misciagna', 'Affiliation': 'Scientific and Ethical Committee, University Hospital Policlinico, 70124 Bari, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Bonfiglio', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Mirizzi', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Franco', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sorino', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Caruso', 'Affiliation': 'Ambulatory of Clinical Nutrition, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Cisternino', 'Affiliation': 'Ambulatory of Clinical Nutrition, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buongiorno', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Liuzzi', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Alberto R', 'Initials': 'AR', 'LastName': 'Osella', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}]",Nutrients,['10.3390/nu12061674']
1663,32513460,Effect of Korean folk music intervention on schizophrenia inpatients' emotional behavior and interpersonal relationship functioning.,"Schizophrenia can lead to inappropriate emotional behavior and issues with interpersonal relationship functioning as it becomes chronic. This study aimed to determine the effects of a Korean folk music therapy program on the emotional behavior and interpersonal relationship functioning of patients with schizophrenia. Twenty inpatients with schizophrenia in a psychiatric ward in Daegu and North Gyeongsang Province were included in the experimental group, and 24 in the control group. The experimental group participated in a 15-session music therapy program, with two 50-minute sessions per week. For hypothesis testing, Wilks' Lambda based on sphericity testing was used to perform repeated measures ANOVA. The experimental group showed statistically significantly higher levels of emotional behavior (F = 5.814, p < .020) and interpersonal relationship functioning (F = 21.72, p < .001) than the control group, indicating that the Korean folk music therapy program was an effective intervention.",2020,"The experimental group showed statistically significantly higher levels of emotional behavior (F = 5.814, p < .020) and interpersonal relationship functioning (F = 21.72, p < .001) than the control group, indicating that the Korean folk music therapy program was an effective intervention.","['patients with schizophrenia', 'Twenty inpatients with schizophrenia in a psychiatric ward in Daegu and North Gyeongsang Province were included in the experimental group, and 24 in the control group']","['Korean folk music intervention', 'Korean folk music therapy program', '15-session music therapy program']","['interpersonal relationship functioning', 'emotional behavior and interpersonal relationship functioning', 'levels of emotional behavior', ""schizophrenia inpatients' emotional behavior and interpersonal relationship functioning""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",20.0,0.0259774,"The experimental group showed statistically significantly higher levels of emotional behavior (F = 5.814, p < .020) and interpersonal relationship functioning (F = 21.72, p < .001) than the control group, indicating that the Korean folk music therapy program was an effective intervention.","[{'ForeName': 'Kyung Ja', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Han-Il Hospital, South Korea. Electronic address: byoung7273@hanmail.net.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea. Electronic address: khl645@kmu.ac.kr.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.02.002']
1664,32513473,Incidental findings: A practical protocol for reporting elevated depressive symptoms in behavioral health research.,"Intervention studies conducted in caregivers often focus on improving mental health. Consequently, researchers may discover incidental findings like elevated depressive symptoms. Researchers have an ethical obligation to report incidental findings to participants, but no protocols exist for reporting behavioral health symptoms. The purpose of this paper was to describe a protocol for reporting elevated depressive symptoms to participants, based on the protocol used in a national randomized clinical trial of stress-reduction methods for 348 grandmothers raising grandchildren. Each questionnaire included the CES-D scale, and was scored immediately after completion. We established a cut-off score of 30 based on previous research. A registered nurse on the research team called participants with scores over 30 and ascertained whether the participant 1) was aware of the problem and 2) had sought help, and then offered additional resources. Overall, 94 (27%) participants had a CES-D score > 30. The majority (91%) were aware of the problem. About a third of the participants were on medication for their symptoms, and a third were seeing a therapist. Nine participants were not aware they had depressive symptoms. This paper outlines the ethical premise for developing our protocol, details of protocol development, and discussion for how research teams can apply this protocol to their work.",2020,The majority (91%) were aware of the problem.,['348 grandmothers raising grandchildren'],[],"['CES-D scale', 'mental health', 'depressive symptoms']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0337548', 'cui_str': 'Grandchild'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",9.0,0.122803,The majority (91%) were aware of the problem.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Wallace', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America. Electronic address: Mkw47@case.edu.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Jeanblanc', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Musil', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.04.005']
1665,32515740,Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial.,"BACKGROUND


Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression.
OBJECTIVE


We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks.
METHODS


We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9).
RESULTS


A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was -3.6 (SD 6.6) in the intervention group and -3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t 91 =-0.37; P=.72, 95% CI -3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t 84 =-2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ 2 1 =6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention.
CONCLUSIONS


The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733.",2020,The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control.,"['95 participants were enrolled (intervention, n=47; control, n=48', 'patients on a waitlist to receive secondary mental health care services for depression', 'Patients Referred to Secondary Mental Health Care for Depression']","['web-based therapy guided by a coach who had a background in social work', 'leaflet of mental health resources they could access', 'guided web-based therapy', 'Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources']","['depressive symptoms', 'change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9', 'higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score', 'mean change in PHQ-9 scores']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",95.0,0.1837,The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacLean', 'Affiliation': 'School of Journalism and Communication, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Corsi', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Litchfield', 'Affiliation': 'Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kucharski', 'Affiliation': 'Department of Psychiatry, The Ottawa Hospital, Ottawa, ON, Canada.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Genise', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Selaman', 'Affiliation': 'Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Testa', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hatcher', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/15001']
1666,32515747,Feasibility of a Home-Based Tablet App for Dexterity Training in Multiple Sclerosis: Usability Study.,"BACKGROUND


Persons with multiple sclerosis (MS) often experience dexterous difficulties during the performance of activities of daily living, such as fastening buttons, handling coins, or writing, therefore impacting their health-related quality of life. Mobile health (mHealth) solutions, such as tablet apps, may be used to train impaired dexterous skills. The feasibility of a tablet app-based dexterity home-based intervention in MS (TAD-MS) has not been explored yet in persons with MS.
OBJECTIVE


The aim of this pilot study was to evaluate the feasibility and usability of home-based dexterity training with a tablet app in both persons with MS and healthy subjects.
METHODS


A total of 9 persons with MS, aged 35-71 years, with an Expanded Disability Status Scale score between 2 and 7.5, performed the TAD-MS for 4 weeks, five times a week, with each training session lasting approximately 30 minutes. Participants' impaired dexterity was measured by the Nine-Hole Peg Test. A total of 10 age-matched healthy subjects also tested and rated the usability of the app. Outcome measures were the adherence rate as well as usability measured by the System Usability Scale and a Custom User Engagement Questionnaire (CUEQ).
RESULTS


High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8). High system usability scores (ie, mean 85.39%, SD 11.67) and overall high scores given in the CUEQ (ie, mean 8.2/10, SD 1.4) further point to high usability of the app. Neither demographic variables nor dexterity levels affected the use of the app.
CONCLUSIONS


This pilot study is the first to demonstrate high feasibility and usability of a new tablet app-based dexterity home-based training program among both persons with MS and healthy individuals. Whether this kind of training improves dexterity will need to be evaluated in a randomized controlled trial.",2020,"RESULTS


High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8).","['A total of 10 age-matched healthy subjects', '9 persons with MS, aged 35-71 years', 'persons with MS', 'persons with MS and healthy subjects', 'Persons with multiple sclerosis (MS', 'persons with MS and healthy individuals', 'Multiple Sclerosis']","['new tablet app-based dexterity home-based training program', 'home-based dexterity training', 'tablet app-based dexterity home-based intervention in MS (TAD-MS', 'Home-Based Tablet App']","['Expanded Disability Status Scale score', 'High system usability scores', 'feasibility and usability', 'dexterity', 'adherence rate as well as usability measured by the System Usability Scale and a Custom User Engagement Questionnaire (CUEQ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0057150', 'cui_str': 'DAT protocol 1'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",9.0,0.0233663,"RESULTS


High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8).","[{'ForeName': 'Judith Jantine Willemijn', 'Initials': 'JJW', 'LastName': 'van Beek', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Erwin Everardus Henri', 'Initials': 'EEH', 'LastName': 'van Wegen', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Multiple Sclerosis Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Marc Berend', 'Initials': 'MB', 'LastName': 'Rietberg', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Multiple Sclerosis Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nyffeler', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bohlhalter', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Christian Philipp', 'Initials': 'CP', 'LastName': 'Kamm', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nef', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vanbellingen', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}]",JMIR mHealth and uHealth,['10.2196/18204']
1667,32507426,Efficacy of Sweet Violet (Viola odorata) flower oil on the symptoms of adults with allergic rhinitis: A double-blind randomized placebo-controlled clinical trial.,,2020,,['adults with allergic rhinitis'],"['Sweet Violet (Viola odorata) flower oil', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0330464', 'cui_str': 'Viola odorata'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.602706,,"[{'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Yazdi', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kardooni', 'Affiliation': 'Department of otolaryngology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Namjuyan', 'Affiliation': 'Ph.D of Pharmacognosy.'}, {'ForeName': 'Hossein Molavi', 'Initials': 'HM', 'LastName': 'Vardanjani', 'Affiliation': 'MPH Department, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Tafazoli', 'Affiliation': 'Department of Traditional Medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Iran.'}, {'ForeName': 'Amir Mohammad', 'Initials': 'AM', 'LastName': 'Jaladat', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: drjaladat@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102408']
1668,32508338,The effects of hemiplegic shoulder pain on upper extremity motor function and proprioception.,"BACKGROUND


Hemiplegic shoulder pain (HSP) after stroke has negative effects on functional use of hemiplegic arm.
OBJECTIVE


This study aimed to investigate the effects of HSP on upper extremity motor function and proprioception.
METHODS


Hundred and twenty-two patients with hemiplegia were included in this study. The patients' shoulder pain was evaluated by Visual Analog Scale. According to pain scores, patients were divided into two groups as group with HSP (Group 1, n = 76) and group without HSP (Group 2, n = 46). Upper extremity motor function level and proprioception were assessed by using Fugl Meyer Motor Function Scale and the Laser-pointer Assisted Angle Reproduction Test for the 45°, 60° and 90° of shoulder flexion.
RESULTS


Upper extremity motor function and shoulder's proprioceptive sense at each angles of group 1 were found significantly worse than group 2's (p≤0.005). Correlation analysis revealed a significant positive correlation between HSP severity, and upper extremity motor dysfunction and proprioceptive impairment (p < 0.005).
CONCLUSIONS


Presence of HSP is one of the main determinators of upper extremity motor function level and proprioceptive ability at different angles. Management of HSP can make a significant contribution to sensorimotor integration by leading to recovery in the motor function and proprioceptive acuity.",2020,"RESULTS


Upper extremity motor function and shoulder's proprioceptive sense at each angles of group 1 were found significantly worse than group 2's (p≤0.005).",['A hundred and twenty-two patients with hemiplegia'],"['HSP', 'hemiplegic shoulder pain']","[""Upper extremity motor function and shoulder's proprioceptive sense"", 'Visual Analog Scale', 'shoulder pain', 'HSP severity, and upper extremity motor dysfunction and proprioceptive impairment']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0395128,"RESULTS


Upper extremity motor function and shoulder's proprioceptive sense at each angles of group 1 were found significantly worse than group 2's (p≤0.005).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Duray', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Süleyman Demirel University, Isparta, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Baskan', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}]",NeuroRehabilitation,['10.3233/NRE-203049']
1669,32508339,Robot-assisted gait training promotes brain reorganization after stroke: A randomized controlled pilot study.,"BACKGROUND


Robot-assisted gait training (RAGT) can improve walking ability after stroke but the underlying mechanisms are unknown.
OBJECTIVE


We evaluated the changes in the injured brain after RAGT and compared the effects of early start and late start of RAGT.
METHODS


Eleven patients with hemiplegia after stroke undergoing inpatient rehabilitation were examined within 3 months of stroke onset and were randomly assigned into two groups. Group 1 started RAGT with conventional physiotherapy immediately after enrollment, whereas Group 2 underwent conventional physiotherapy for 4 weeks before starting RAGT. We acquired diffusion tensor imaging data after enrollment and at 4 and 8 weeks after treatment. Fractional anisotropy (FA) and mean diffusivity (MD) maps were used to analyze the neural changes.
RESULTS


Repeated measures analysis of variance of the data at 4 weeks after treatment showed a significant interaction between time and groups (RAGT versus control) for the FA and MD values in the non-lesioned hemisphere, indicating that the non-lesioned hemisphere was significantly reorganized by RAGT compared with conventional physiotherapy. Analysis of the data at 8 weeks after treatment showed a significant interaction between time and groups (early and late start of RAGT) for the MD values in the motor-related areas bilaterally, indicating that early start of RAGT significantly accelerated bi-hemispheric reorganization as compared with late start of RAGT.
CONCLUSIONS


Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri. Furthermore, early start of RAGT can accelerate bi-hemispheric reorganization in the motor-related brain regions.",2020,"Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri.",['Eleven patients with hemiplegia after stroke undergoing inpatient rehabilitation were examined within 3 months of stroke onset'],"['conventional physiotherapy', 'Robot-assisted gait training (RAGT', 'Robot-assisted gait training', 'RAGT']",['Fractional anisotropy (FA) and mean diffusivity (MD) maps'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",11.0,0.0447341,"Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri.","[{'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Chang Soon', 'Initials': 'CS', 'LastName': 'Kang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sohyun', 'Initials': 'S', 'LastName': 'Kyeong', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}]",NeuroRehabilitation,['10.3233/NRE-203054']
1670,32508341,"Combined effects of backward treadmill training and botulinum toxin type A therapy on gait and balance in patients with chronic stroke: A pilot, single-blind, randomized controlled trial.","BACKGROUND


Backward walking is recommended to improve the components of physiological gait in neurological disease. Botulinum toxin type A is an effective safe first line-treatment for post-stroke spasticity.
OBJECTIVE


To compare the effects of backward treadmill training (BTT) versus standard forward treadmill training (FTT) on motor impairment in patients with chronic stroke receiving botulinum toxin type A therapy.
METHODS


Eighteen chronic stroke patients were randomly assigned to receive BTT (n = 7) or FTT (n = 11) as adjunct to botulinum toxin type A therapy. A total of twelve 40-minute sessions (3 sessions/week for 4 weeks) of either BTT or FTT were conducted. A blinded assessor evaluated the patients before and after treatment. The primary outcome was the 10-meter Walking Test (10 MWT). Secondary outcomes were the modified Ashworth Scale, gait analysis, and stabilometric assessment.
RESULTS


Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment.
CONCLUSIONS


Greater improvement in gait and balance was noted after BTT than after FTT as an adjunct to botulinum toxin therapy in patients with chronic stroke.",2020,"RESULTS


Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment.
","['patients with chronic stroke receiving botulinum toxin type A therapy', 'Eighteen chronic stroke patients', 'patients with chronic stroke']","['BTT or FTT', 'BTT', 'backward treadmill training (BTT) versus standard forward treadmill training (FTT', 'backward treadmill training and botulinum toxin type', 'botulinum toxin type A therapy', 'Botulinum toxin type A', 'FTT', 'botulinum toxin therapy']","['length of CoP', 'stabilometric assessment [length of centre of pressure CoP', 'modified Ashworth Scale, gait analysis, and stabilometric assessment', '10\u200aMWT', '10-meter Walking Test (10\u200aMWT', 'gait and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",18.0,0.0763676,"RESULTS


Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment.
","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serina', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Disarò', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Modenese', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203067']
1671,32510644,Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate for root coverage: 2-year results of an RCT using 3D digital measuring for volumetric comparison of gingival dimensions.,"AIM


The aim of this randomized clinical trial was to compare clinical and volumetric outcomes of tunnel technique (TUN) with subepithelial connective tissue graft (CTG) versus coronally advanced flap (CAF) with enamel matrix derivate (EMD) 2 years after gingival recession (GR) treatment.
MATERIALS AND METHODS


Twenty-three patients contributed 45 Miller class I or II GR. At baseline and follow-up examinations, study models were collected. Their three-dimensional scans allowed precise computer-assisted measurement of recession depth (REC), complete root coverage (CRC), percentage of root coverage (RC), pointwise (pTHK) and mean areal (aTHK) marginal soft tissue thickness. Clinical examination delivered probing depths (PPD) and height of keratinized tissue.
RESULTS


24 months after surgery, digitally evaluated CRC was present in 60.0% of the TUN + CTG and 0.0% of the CAF + EMD-treated sites (p < .0001), meaning a certain relapse of the gingival margin ragarding both approaches. RC amounted to 94.0% (TUN + CTG) and 57.3% (CAF + EMD), respectively (p < .0001). REC reduction (RECred) was significantly higher for TUN + CTG (1.81 ± 0.56 mm) than for CAF + EMD (0.90 ± 0.45 mm) (p < .0001). pTHK and aTHK values were significantly greater in the TUN + CTG group (1.41 ± 0.35 mm and 1.11 ± 0.26 mm) than in the CAF + EMD group (0.78 ± 0.32 mm and 0.60 ± 0.26 mm) (p < .0001). Statistical analysis detected positive correlations between THK and both RC and RECred (p < .001).
CONCLUSIONS


Two years post-operatively, CTG showed better clinical and volumetric outcomes than EMD. Increased THK values were associated with improved outcomes regarding RC and RECred.",2020,REC reduction (RECred) was significantly higher for TUN+CTG (1.81±0.56mm) than for CAF+EMD (0.90±0.45mm) (p<0.0001).,['23 patients contributed 45 Miller class I or II GR'],"['TUN+CTG', 'Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate', 'tunnel technique (TUN) with subepithelial connective tissue graft (CTG) versus coronally advanced flap (CAF) with enamel matrix derivate (EMD']","['REC reduction (RECred', 'Clinical examination delivered probing depths (PPD) and height of keratinized tissue (HKT', 'RC', 'recession depth (REC), complete root coverage (CRC), percentage of root coverage (RC), pointwise (pTHK) and mean areal (aTHK) marginal soft tissue thickness', 'pTHK and aTHK values', 'Increased THK values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]","[{'cui': 'C0080232', 'cui_str': 'Transplantation, Tissue'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]","[{'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0465349,REC reduction (RECred) was significantly higher for TUN+CTG (1.81±0.56mm) than for CAF+EMD (0.90±0.45mm) (p<0.0001).,"[{'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Zuhr', 'Affiliation': 'Private Practice Hürzeler/Zuhr, Munich, Germany.'}, {'ForeName': 'Stephan F', 'Initials': 'SF', 'LastName': 'Rebele', 'Affiliation': 'Private Practice Rebele, Dinkelsbühl, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Faculty of Medicine and Medical Center, Institute of Medical Biometry and Statistics, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Petsos', 'Affiliation': 'Department of Periodontology, Center of Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Hürzeler', 'Affiliation': 'Private Practice Hürzeler/Zuhr, Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical periodontology,['10.1111/jcpe.13328']
1672,32510734,"Azithromycin and COVID-19: Prompt early use at first signs of this infection in adults and children, an approach worthy of consideration.","The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19. Initial enthusiasm for the combination of hydroxychloroquine and azithromycin has abated. However, as a result of positive clinical experience with azithromycin used alone during the first few days of the flu-like illness caused by this coronavirus, we recommend formal clinical trials using azithromycin early in the course of a COVID-19 infection. There is one clinical trial initiated, the individually randomized, telemedicine-based, ""Azithromycin for COVID-19 Treatment in Outpatients Nationwide"" based at the University of California San Francisco. This placebo-controlled trial is designed to determine the efficacy of a single 1.2-g dose of oral azithromycin to prevent COVID-19 patient progression to hospitalization. We recommend formal clinical trials of azithromycin in its prepackaged form at the first sign of COVID-19 infection in adults and children, using an initial adult dose of 500 mg followed by 250 mg per day for 4 days, a total cumulative dose of 1.5 g, and for children 5 to 18 years of age, 10 mg/kg on the first day followed by 5 mg/kg for 4 days.",2020,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"['Adults and Children', 'Outpatients Nationwide (ACTION)"" based at the University of California San Francisco', 'adults and children']","['hydroxychloroquine and azithromycin', 'telemedicine-based, ""Azithromycin', 'Azithromycin', 'azithromycin', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0479328,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schwartz', 'Affiliation': 'Professor of Dermatology and Pathology, Rutgers University New Jersey Medical School, Newark, New Jersy, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Suskind', 'Affiliation': 'Professor of Pediatrics and Founding Dean Emeritus, California University of Science of Medicine, San Bernardino, California, USA.'}]",Dermatologic therapy,['10.1111/dth.13785']
1673,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143']
1674,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1675,32512498,"Assessing the effectiveness of a pediatrician-led newborn parenting class on maternal newborn-care knowledge, confidence and anxiety: A quasi-randomized controlled trial.","BACKGROUND


The postpartum hospital stay is a unique opportunity for clinicians to educate parents on the importance of promoting early child development. Pediatricians are well-positioned to address both medical and developmental concerns during critical periods of development, yet very few parenting interventions are led by pediatricians.
AIMS


To assess the impact of a novel one-hour long pediatrician-led Newborn Class on maternal knowledge, confidence, and anxiety.
METHODS


We conducted a quasi-randomized controlled trial to evaluate the effectiveness of the Newborn Class. First-time mothers who delivered a full-term singleton vaginally with no major complications and attended the class were recruited. Mothers who expressed a desire to attend the class but were discharged before a class was offered served as controls.
OUTCOME MEASURES


Maternal self-perceived parental confidence and anxiety were measured using standardized scales [Karitane Parenting Confidence Scale (KPCS) and State-Trait Anxiety Inventory for Adults (STAI-AD)]. Knowledge on newborn care was assessed using a novel scale.
RESULTS


A total of 84 participants (intervention n = 36, control n = 48) were included in the study. Mothers who attended the class showed significantly higher levels of knowledge compared to the control group (Knowledge test, Two-tailed t-test, mean [SD], 8.08 [1.06] vs 6.78 [1.25]; P<0.001) as well as significantly higher parenting confidence levels (KPCS, Two-tailed t-test, mean [SD], 39.31 [3.88] vs 35.20 [3.99]; P<0.001). No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164).
CONCLUSIONS


A short pediatrician-led parenting intervention may be an effective tool in improving maternal confidence and newborn care knowledge. Given the importance of the newborn period in establishing healthy developmental trajectories, there is a crucial need for cost- and time-effective intervention that can be widely implemented to promote parental knowledge and confidence with the ultimate goal of fostering healthy development in children.",2020,"No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164).
","['Mothers who expressed a desire to attend the class but were discharged before a class was offered served as controls', 'First-time mothers who delivered a full-term singleton vaginally with no major complications and attended the class were recruited', '84 participants (intervention n\xa0=\xa036, control n\xa0=\xa048) were included in the study']","['pediatrician-led newborn parenting class', 'novel one-hour long pediatrician-led Newborn Class', 'Newborn Class']","['maternal knowledge, confidence, and anxiety', 'levels of knowledge', 'standardized scales [Karitane Parenting Confidence Scale (KPCS) and State-Trait Anxiety Inventory for Adults (STAI-AD', 'overall level of anxiety (STAI-AD', 'Maternal self-perceived parental confidence and anxiety', 'parenting confidence levels (KPCS', 'maternal newborn-care knowledge, confidence and anxiety']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}]",84.0,0.0881763,"No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164).
","[{'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Gozali', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States; Columbia University Irving Medical Center, Departments of Pediatrics and Psychiatry, Pardes Rm 4932, 1051 Riverside Drive, New York, NY 10032, United States. Electronic address: ag3827@columbia.edu.'}, {'ForeName': 'Sherika', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: sherikagibson95@gmail.com.'}, {'ForeName': 'Lianna R', 'Initials': 'LR', 'LastName': 'Lipton', 'Affiliation': ""Boston Children's Hospital, Department of Pediatrics - Division of Developmental Medicine, 300 Longwood Avenue, Boston, MA 02115, United States. Electronic address: lianna.lipton@childrens.harvard.edu.""}, {'ForeName': 'Aliza W', 'Initials': 'AW', 'LastName': 'Pressman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: aliza.pressman@gmail.com.'}, {'ForeName': 'Blair S', 'Initials': 'BS', 'LastName': 'Hammond', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: blair.hammond@mssm.edu.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Dumitriu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States; Columbia University Irving Medical Center, Departments of Pediatrics and Psychiatry, Pardes Rm 4932, 1051 Riverside Drive, New York, NY 10032, United States. Electronic address: dani.dumitriu@columbia.edu.'}]",Early human development,['10.1016/j.earlhumdev.2020.105082']
1676,32513317,Cracker shape modifies  ad libitum  snack intake of crackers with cheese dip.,"Food and energy intake can be effectively lowered by changing food properties, but little is known whether modifying food shape is sufficient to influence intake. This study investigated the influence of cracker shape and cheese viscosity on ad libitum intake of cracker-cheese combinations. Forty-four participants (thirteen males, 23 (sd 3) years, BMI 21 (sd 2) kg/m2) participated in four late afternoon snack sessions (2 × 2 randomised crossover design). Iso-energetic crackers were baked into flat squares and finger-shape cylindrical sticks and combined with a cheese dip varying in viscosity. Approximately eighty crackers and 500 g cheese dip were served in separate large bowls. Participants consumed crackers with cheese dip ad libitum while watching a movie of 30 min. Dipping behaviour and oral processing behaviour were measured simultaneously by hidden balances under the cheese bowls and video recordings. Cracker intake (28 (sem 1) crackers) of cracker-cheese combinations was not influenced by cracker shape. Cheese intake of cracker-cheese combinations was 15 % higher for flat-squared than finger-shape crackers (131 kJ, P = 0·016), as a larger amount of cheese was scooped with flat-squared crackers (2·9 (sem 0·2) v. 2·3 (sem 0·1) g cheese per dip, P < 0·001) and showed higher eating rate and energy intake rate (P < 0·001). Eating rate over snacking time decreased by reducing bite frequency (P < 0·001) while cheese dip size remained fairly constant (P = 0·12). Larger energy intake from condiments was facilitated by increased cracker surface, and this did not trigger earlier satiation. Changing food carrier surface may be a promising approach to moderate energy intake of often high energy dense condiments, sauces and toppings.",2020,Eating rate over snacking time decreased by reducing bite frequency (p<0.001) while cheese dip size remained fairly constant (p=0.12).,"['crackers with cheese dip', 'Forty-four participants (13 males, 23±3 years, BMI 21±2 kg/m2) participated in four late afternoon snack sessions [2x2 randomized crossover design']",[],"['Eating rate over snacking time', 'Dipping behaviour and oral processing behaviour', 'eating rate and energy intake rate', 'Cheese intake of cracker-cheese combinations', 'bite frequency']","[{'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]",[],"[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0585041', 'cui_str': 'Snack time'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0556187', 'cui_str': 'Cheese intake'}, {'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",44.0,0.0651299,Eating rate over snacking time decreased by reducing bite frequency (p<0.001) while cheese dip size remained fairly constant (p=0.12).,"[{'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'van Eck', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'van Stratum', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700AA Wageningen, The Netherlands.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Achlada', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700AA Wageningen, The Netherlands.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Goldschmidt', 'Affiliation': ""BEL Group, Structure-Function Research 7-bd de l'Industrie, BP40077, 41102Vendôme Cedex, France.""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Scholten', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fogliano', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stieger', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Dieuwerke', 'Initials': 'D', 'LastName': 'Bolhuis', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700AA Wageningen, The Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114520002056']
1677,32515099,Alcohol use and injury risk in Thailand: A case-crossover emergency department study.,"INTRODUCTION AND AIMS


While injuries and alcohol contribute to a large proportion of the disease burden in Thailand, no well-designed underlying study has yet been published. This study aims to evaluate the relationship between acute alcohol consumption and injury risk in Thailand.
DESIGN AND METHODS


Using the case-crossover design, this study examined 520 injured patients aged 18 years and older from two emergency departments in Meuang District, Chiang-Mai Province, Thailand, from June to August of 2016. The case period was defined as 6 h prior to injury, the two control periods as the same 6-h period at 1 day and 7 days prior to injury. Alcohol exposure and the amount consumed were measured for these periods.
RESULTS


Twenty percent of injured patients consumed alcohol within the 6 h prior to injury, averaging 6.9 drinks during that time. The odds of injury for those individuals consuming alcoholic beverages was 5.0 (95% confidence interval 3.0, 8.2) times greater compared to non-exposure individuals; every additional drink consumed increased the odds of injury by 1.3 (95% confidence interval 1.2, 1.4). Alcohol use significantly increased the odds of sustaining an unintentional injury, intentional injury inflicted by someone else or experiencing a road traffic injury (among drivers). The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers).
DISCUSSION AND CONCLUSIONS


Exposure to alcohol increased the odds of injury in a dose-dependent fashion; hence, comprehensive, cost-effective strategies should be implemented in Thailand to reduce alcohol exposure, binge drinking and drunk driving.",2020,"The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers).
","['520 injured patients aged 18\u2009years and older from two emergency departments in Meuang District, Chiang-Mai Province, Thailand, from June to August of 2016', 'Thailand']",[],"['risks of unintentional injury and road traffic injuries', 'odds of sustaining an unintentional injury, intentional injury inflicted by someone else or experiencing a road traffic injury']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151736', 'cui_str': 'Accidental injury'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0151737', 'cui_str': 'Intentional injury'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",520.0,0.0189327,"The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers).
","[{'ForeName': 'Bundit', 'Initials': 'B', 'LastName': 'Sornpaisarn', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'Sarnti', 'Initials': 'S', 'LastName': 'Sornpaisarn', 'Affiliation': 'Faculty of Health Science, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Shield', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}]",Drug and alcohol review,['10.1111/dar.13094']
1678,32520445,Effect of long-term use of unfractionated or low-molecular-weight heparin on bone mineral density in maintenance hemodialysis patients.,"INTRODUCTION


Long-term use of unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) causes bone loss and osteoporosis in patients not receiving hemodialysis. This study aimed to investigate the effect of UFH and LMWH on bone mineral density (BMD) in patients undergoing maintenance hemodialysis (MHD).
METHODS


Patients undergoing MHD using UFH or LMWH as anticoagulants were enrolled. BMD (in g/cm 2  ), T-score and Z-score (BMDs) were measured at the lumbar spine and femur neck using dual-energy X-ray absorptiometry (DXA) at baseline and 2 years later. Patient demographics and clinical indices were collected. Correlation analysis was used to identify significant predictors of bone loss. Multiple linear regression was used to explore the relationship between heparin type and bone loss progression.
FINDINGS


A total of 104 patients were enrolled and completed the baseline BMD test; 72 completed the test again 2 years later. Six patients were excluded because they used both UFH and LMWH. Although BMD decreased in some patients in the UFH group, a slight increase in the BMD was observed on an average in the LMWH group after 2 years. The mean change in BMD (in g/cm 2  ) [0(-0.03,0.04) vs. 0.04(0,0.06), P = 0.023], T-score [0(-0.40,0.30) vs. 0.35(-0.03,0.53), P = 0.038], and Z-score [0.10(-0.30,0.40) vs. 0.45(0.08,0.63), P = 0.031] in the lumbar spine in the UFH group was lower than those in the LMWH group. Femur neck BMD did not change significantly. In a linear regression model, after adjusting for diabetes mellitus, parathyroid hormone, and serum phosphate, we did not find an association between heparin substances and BMD.
DISCUSSION


UFH might be associated with loss of lumbar spine BMD in patients undergoing MHD.",2020,"The mean change in BMD (in g/cm 2  ) [0(-0.03,0.04) vs. 0.04(0,0.06), P = 0.023], T-score [0(-0.40,0.30) vs. 0.35(-0.03,0.53), P = 0.038], and Z-score [0.10(-0.30,0.40) vs. 0.45(0.08,0.63), P = 0.031] in the lumbar spine in the UFH group was lower than those in the LMWH group.","['Patients undergoing MHD using UFH or LMWH as anticoagulants were enrolled', '104 patients were enrolled and completed the baseline BMD test; 72 completed the test again 2\u2009years later', 'patients undergoing maintenance hemodialysis (MHD', 'patients undergoing MHD', 'maintenance hemodialysis patients', 'patients not receiving hemodialysis']","['LMWH', 'UFH and LMWH', 'unfractionated or low-molecular-weight heparin', 'UFH', 'unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH']","['bone mineral density', 'mean change in BMD', 'Femur neck BMD', 'BMD', 'bone mineral density (BMD', 'T-score and Z-score (BMDs', 'lumbar spine', 'lumbar spine BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",104.0,0.0402643,"The mean change in BMD (in g/cm 2  ) [0(-0.03,0.04) vs. 0.04(0,0.06), P = 0.023], T-score [0(-0.40,0.30) vs. 0.35(-0.03,0.53), P = 0.038], and Z-score [0.10(-0.30,0.40) vs. 0.45(0.08,0.63), P = 0.031] in the lumbar spine in the UFH group was lower than those in the LMWH group.","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Niu', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Liangying', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Lingxue', 'Initials': 'L', 'LastName': 'Tu', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12854']
1679,32520721,"Interleukin-2 drives cortisol secretion in an age-, dose-, and body composition-dependent way.","Background


Interleukin-2 (IL-2), one of the proinflammatory cytokines, is used in the treatment of certain malignancies. In some studies, transient increases in cortisol and ACTH secretion occurred. Thus, this agent may be used as an experimental probe of adrenal cortisol secretion.
Objective


This study quantifies the effects of low and moderate doses of IL-2 on cortisol secretion and assesses the modulation by age, dose and body composition.
Site


Mayo Clinical Translational Research Unit.
Subjects


Study comprised 35 healthy men, 17 young and 18 older.
Methods


Randomized prospective double-blind saline-controlled study of IL-2 administration in two doses with concurrent 10-min blood sampling for 24 h.
Outcome measures


Deconvolution analysis and approximate entropy of cortisol secretion.
Results


Low-dose IL-2 administration increased nocturnal pulsatile cortisol secretion from 1460 ± 160 to 2120 ± 220 nmol/L/8 h in young subjects and from 1680 ± 105 to 1960 ± 125 nmol/L/8 h (treatment P < 0.0001, but more in young than older, P = 0.02). Comparable results were obtained for total cortisol secretion (P treatment <0.0001, age effect P = 0.005). The higher IL-2 dose caused a large increase in young (P < 0.0001), but not in older (P = 0.90) subjects. This dose also increased approximate entropy from 0.877 ± 0.041 to 1.024 ± 0.049 (P = 0.008), pointing to reduced secretory orderliness. Incremental cortisol (nocturnal) secretion correlated negatively with visceral fat mass (R = -0.41, P = 0.019).
Conclusion


In healthy men, IL-2 injection drives pulsatile cortisol secretion in a dose-dependent way in young, but not older, individuals and erodes cortisol secretory orderliness at a higher dose in young subjects. Cortisol responses are diminished with increasing abdominal visceral fat mass.",2020,"The higher IL2 dose caused a large increase in young (P<0.0001), but not in older (P=0.90) subjects.","['35 healthy men, 17 young and 18 older', 'healthy men', 'Site']","['IL-2', 'IL-2 injection']","['Cortisol responses', 'nocturnal pulsatile cortisol secretion', 'Incremental cortisol (nocturnal) secretion', 'Deconvolution analysis and Approximate Entropy of cortisol secretion', 'visceral fat mass', 'total cortisol secretion', 'cortisol and ACTH secretion', 'Interleukin-2 drives cortisol secretion']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",35.0,0.0249157,"The higher IL2 dose caused a large increase in young (P<0.0001), but not in older (P=0.90) subjects.","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo Clinic College of Medicine, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Takahashi', 'Affiliation': 'Primary Care Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo Clinic College of Medicine, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota, USA.'}]",Endocrine connections,['10.1530/EC-20-0211']
1680,32522090,Decision Regret among Informal Caregivers Making Housing Decisions for Older Adults with Cognitive Impairment: A Cross-sectional Analysis.,"Background . Informal caregivers are regularly faced with difficult housing decisions for older adults with cognitive impairment. They often regret the decision they made. We aimed to identify factors associated with decision regret among informal caregivers engaging in housing decisions for cognitively impaired older adults.  Methods . We performed a secondary analysis of cross-sectional data collected from a cluster-randomized trial. Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults. Decision regret was assessed after caregivers' enrollment in the study using the Decision Regret Scale (DRS), scored from 0 to 100. We used a conceptual framework of potential predictors of regret to identify independent variables. We performed multilevel analyses using a mixed linear model by estimating fixed effects (β) and 95% confidence intervals (CIs).  Results . The mean (SD) DRS score of 296 informal caregivers (mean [SD] age, 62 [12] years) was 12.4 (18.4). Factors associated with less decision regret were having a college degree compared to primary education (β [95% CI]: -11.14 [-18.36, -3.92]), being married compared to being single (-5.60 [-10.05, -1.15]), informal caregivers' perception that a joint process occurred (-0.14 [-0.25, -0.02]), and older adults' not having a specific housing preference compared to preferring to stay at home (-4.13 [-7.40, -0.86]). Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]).  Limitations . Our analysis may not illustrate all predictors of decision regret among informal caregivers.  Conclusions . Our findings will allow risk-mitigation strategies for informal caregivers at risk of experiencing regret.",2020,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]).  ","['Older Adults with Cognitive Impairment', 'older adults with cognitive impairment', 'Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults', 'cognitively impaired older adults']",[],"['mean (SD) DRS score', 'decision regret', ""informal caregivers' perception that a joint process"", 'higher burden of care', 'Decision regret', 'higher decisional conflict', 'Decision Regret Scale (DRS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.118618,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]).  ","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Elidor', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ben Charif', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Codjo Djignefa', 'Initials': 'CD', 'LastName': 'Djade', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20925368']
1681,32505785,Effect of a 10-month residential multidisciplinary weight loss intervention on food reward in adolescents with obesity.,"BACKGROUND


While multidisciplinary weight loss (WL) programs have been suggested to improve the sensitivity of appetite control system, this study examined for the first time the effect of a specific multidisciplinary intervention on the hedonic aspects of food intake in adolescents with obesity.
STUDY DESIGN


Twenty-four adolescents (11-15 years) with obesity (mean BMI: 35.7 ± 4.5 kg/m 2 ; BMI percentile: 98.7 ± 0.5) took part in a 10-month inpatient WL program, which included physical activity, nutritional education and psychological support. Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits were assessed at baseline, 5 months and at the end of the 10-month intervention. Analyses were conducted with linear mixed models and paired t-tests.
RESULTS


The mean WL was 8.9 ± 6.9 kg. Appetite sensations and pre-meal hedonic ratings of liking for all food categories (HF: high-fat; LF: low-fat; SA: savory; SW: sweet) increased after 5 months (fasting hunger, p = 0.02; fasting desire to eat, p = 0.01; daily hunger, p = 0.001; pre-meal liking for HFSA, p = 0.03; LFSA, p = 0.04; HFSW, p = 0.009; LFSW, p = 0.005). In contrast, appetite sensations (fasting and daily), emotional eating (p < 0.001), uncontrolled eating (p = 0.009), and pre-meal explicit liking (for all food categories) decreased between months 5 and 10. Post-meal liking for HFSA (p < 0.001), LFSA (p = 0.002), HFSW (p = 0.02) and LFSW (p < 0.001) decreased between baseline and month 5 and remained unchanged between months 5 and 10.
CONCLUSION


These findings suggest that adaptive mechanisms to WL occurring in the short-to-medium term are attenuated in the longer term with the persistence of WL. These results indicate improvements in the reward response to food in adolescents with obesity and may contribute to the beneficial effect of multicomponent WL interventions in this population. Future studies are required to confirm these findings and elucidate underlying mechanisms.",2020,Post-meal liking for HFSA (p<0.001),"['adolescents with obesity', 'Twenty-four adolescents (11-15 years) with obesity']",['residential multidisciplinary weight loss intervention'],"['Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits', 'appetite sensations (fasting and daily), emotional eating (p<0.001), uncontrolled eating (p=0.009), and pre-meal explicit liking', 'HFSW', 'Appetite sensations and pre-meal hedonic ratings of liking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",24.0,0.0263658,Post-meal liking for HFSA (p<0.001),"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France. Electronic address: maud.miguet@neuro.uu.se.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Department of Human Nutrition, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112996']
1682,32505810,Improving Oral Health and Modulating the Oral Microbiome to Reduce Bloodstream Infections from Oral Organisms in Pediatric and Young Adult Hematopoietic Stem Cell Transplantation Recipients: A Randomized Controlled Trial.,"Bloodstream infections (BSIs) from oral organisms are a significant cause of morbidity and mortality in hematopoietic stem cell transplantation (HSCT) recipients. There are no proven strategies to decrease BSIs from oral organisms. The aim of this study was to evaluate the impact of daily xylitol wipes in improving oral health, decreasing BSI from oral organisms, and modulating the oral microbiome in pediatric HSCT recipients. This was a single-center 1:1 randomized controlled trial in pediatric HSCT recipients age >2 years. Age-matched healthy children were enrolled to compare the oral microbiome. The oral hygiene standard of care (SOC) group continued to receive the standard oral hygiene regimen. The xylitol group received daily oral xylitol wipes (with .7 g xylitol) in addition to the SOC. The intervention started from the beginning of the transplantation chemotherapy regimen and extended to 28 days following transplantation. The primary outcome was oral health at interval time points, and secondary outcomes included BSIs from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance. The study was closed early due to efficacy after an interim analysis of the first 30 HSCT recipients was performed (SOC group, n = 16; xylitol group, n = 14). The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (P = .031, .0039, and .0005, respectively); oral plaque at days 7 and 14 (P = .045 and .0023, respectively); and oral ulcers >10 mm at day 14 (P = .049) compared with the SOC group. The xylitol group had no BSI from oral organisms compared with the SOC group, which had 4 (P = .04). The xylitol group had significantly lower abundance of potential BSI pathogens, such as Staphylococcus aureus (P = .036), Klebsiella pneumoniae (P = .033), and Streptococcus spp (P = .011) at the day after transplantation compared with the SOC group. Healthy children and young adults had significantly increased oral microbiome diversity compared with all HSCT recipients (P < .001). The addition of xylitol to standard oral care significantly improves oral health, decreases BSI from oral organisms, and decreases the abundance of pathogenic oral organisms in pediatric and young adult HSCT recipients.",2020,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","['hematopoietic stem cell transplant (HSCT) recipients', 'Age matched healthy children', 'pediatric HSCT recipients older than 2 years', 'Healthy children and young adults', 'pediatric and young adult HSCT recipients', 'Pediatric and Young Adult Hematopoietic Stem Cell Transplant Recipients', 'pediatric HSCT recipients']","['daily oral xylitol wipes (with 0.7gm xylitol', 'oral hygiene standard of care (SOC', 'xylitol']","['Klebsiella pneumoniae', 'oral health', 'oral ulcers', 'rate of gingivitis', 'oral microbiome diversity', 'abundance of potential BSI pathogens such as Staphylococcus aureus', 'oral plaque', 'oral health at interval time points, and secondary outcomes included blood stream infections from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance', 'pathogenic oral organism abundance']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",30.0,0.10366,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Badia', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona. Electronic address: pbadia@phoenixchildrens.com.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': ""Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Haslam', 'Affiliation': ""Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Nelson', 'Affiliation': ""Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Pate', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Golkari', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Teusink-Cross', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flesch', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Ashely', 'Initials': 'A', 'LastName': 'Bedel', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hickey', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Kramer', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Davies', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Sarat', 'Initials': 'S', 'LastName': 'Thikkurissy', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Dandoy', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.019']
1683,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND


Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes.
OBJECTIVES


We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL).
METHODS


46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS.
RESULTS


There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion.
CONCLUSIONS


Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015']
1684,32512234,Oxygen supplementation increases the total work and muscle damage markers but reduces the inflammatory response in COPD patients.,"INTRODUCTION


Oxygen supplementation (O 2 -Suppl) is recommended for pulmonary rehabilitation with higher exercise intensities. However, high-intensity exercise tends toward muscle damage and a greater inflammatory response. We aimed to investigate the effect of O 2 -Suppl during exercise test (EET) on CRP level and muscle damage (CPK, LDH, lactate) in non-hypoxemic COPD patients.
METHODS


Eleven non-depleted patients with COPD (FEV 1  65.5 ± 4.3 %) performed two EET (room-air or O 2 -Suppl-100 %), through a blind, randomized, and placebo-controlled crossover design. CPK, LDH and CRP were measured before, immediately after and 24 h after EET.
RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3 %; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L). The O 2 -Suppl protocol resulted in a lower increase in CRP (92.1 ± 112.4 % vs. 400.1 ± 384.9 %; p = 0.003).
CONCLUSIONS


O 2 -Suppl increases exercise-tolerance, resulting in increased muscle injury markers in COPD. However, oxygen supplementation attenuates the inflammatory response, even upon increased physical exercise.",2020,"RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","['Eleven non-depleted patients with COPD (FEV 1  65.5\u2009±\u20094.3%) performed two EET (room-air or O 2 -Suppl-100', 'COPD patients', 'non-hypoxemic COPD patients']","['oxygen supplementation', 'Oxygen supplementation (O 2 -Suppl', 'O 2 -Suppl during exercise test (EET', 'Oxygen supplementation', 'placebo']","['Exercise time', 'CRP', 'CPK and LDH', 'CPK, LDH and CRP', 'total work and muscle damage markers', 'physical exercise', 'exercise-tolerance', 'CRP level and muscle damage (CPK, LDH, lactate', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",11.0,0.185322,"RESULTS


Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","[{'ForeName': 'Daniela Rodrigues', 'Initials': 'DR', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Kelly Critine', 'Initials': 'KC', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Julia Sampel', 'Initials': 'JS', 'LastName': 'de Castro', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Viviani Aparecida', 'Initials': 'VA', 'LastName': 'Lara', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'de Luca', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil.'}, {'ForeName': 'Mayron F', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; VO2Care Research Group, Research Physiotherapy Coordinator of Vila Nova Star Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Wladimir Musetti', 'Initials': 'WM', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil; Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil; Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; HEART - Institute of Cardiology, Department of Education and Research, São Paulo, Brazil. Electronic address: wmusettimedeiros@hotmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103475']
1685,32512782,"Further Evidence of Benefits to Mood and Working Memory from Lipidated Curcumin in Healthy Older People: A 12-Week, Double-Blind, Placebo-Controlled, Partial Replication Study.","Curcumin (a flavonoid isolated from turmeric) affects several processes involved in neurocognitive aging. We have previously reported that short term (4-weeks) administration of a highly bioavailable curcumin preparation (Longvida©) improved working memory and reduced fatigue and stress reactivity in a healthy older cohort. The present trial (ACTRN12616000484448) was a partial replication study, evaluating similar effects at 4 and 12-weeks Longvida© supplementation. A double-blind, placebo-controlled, parallel-groups trial was conducted. Eighty participants aged 50-80 years (mean = 68.1, SD = 6.34) were randomised to receive Longvida© (400 mg daily containing 80 mg curcumin) or a matching placebo. Assessment took place at baseline then following 4 and 12 weeks treatment. Outcome measures included cognitive performance, mood and biomarkers. Compared with placebo, curcumin was associated with several significant effects. These included better working memory performance at 12-weeks (Serial Threes, Serial Sevens and performance on a virtual Morris Water Maze), and lower fatigue scores on the Profile of Mood States (POMS) at both 4 and 12-weeks, and of tension, anger, confusion and total mood disturbance at 4-weeks only. The curcumin group had significantly elevated blood glucose. These results confirm that Longvida© improves aspects of mood and working memory in a healthy older cohort. The pattern of results is consistent with improvements in hippocampal function and may hold promise for alleviating cognitive decline in some populations.",2020,The curcumin group had significantly elevated blood glucose.,"['healthy older cohort', 'Healthy Older People', 'Eighty participants aged 50-80 years (mean = 68.1, SD = 6.34']","['Longvida© (400 mg daily containing 80 mg curcumin) or a matching placebo', 'Placebo', 'highly bioavailable curcumin preparation (Longvida©', 'placebo']","['working memory and reduced fatigue and stress reactivity', 'working memory performance', 'elevated blood glucose', 'hippocampal function', 'tension, anger, confusion and total mood disturbance', 'cognitive performance, mood and biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",80.0,0.539035,The curcumin group had significantly elevated blood glucose.,"[{'ForeName': 'Katherine H M', 'Initials': 'KHM', 'LastName': 'Cox', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipingas', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'Kaylass', 'Initials': 'K', 'LastName': 'Poorun', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}]",Nutrients,['10.3390/nu12061678']
1686,32512862,Effect of Serum SPARC Levels on Survival in Patients with Digestive Tract Cancer: A Post Hoc Analysis of the AMATERASU Randomized Clinical Trial.,"Observational studies suggest that physical activity may improve, whereas sarcopenia may worsen the survival of cancer patients. It has been suggested that secreted protein acidic and rich in cysteine (SPARC), one of the myokines that is secreted into the bloodstream by muscle contraction, has tumor-suppressive effects. Based on the hypothesis that serum SPARC level may be a potential prognostic biomarker, a post hoc analysis of the AMATERASU randomized, double-blind, placebo-controlled trial of postoperative oral vitamin D supplementation (2000 IU/day) in patients with stage I-III digestive tract cancer from the esophagus to the rectum (UMIN000001977) was conducted with the aim of exploring the association between serum SPARC levels after operation and survival. On multivariate analyses adjusting serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy, patients with SPARC levels lower than the median level had a significantly higher risk for death than those with higher levels (hazard ratio, 2.25; 95% confidence interval, 1.25-4.05;  p  = 0.007), whereas there were no significant associations with other outcomes including recurrence. However, on the same multivariate analyses, sarcopenia was not a risk factor for death and/or relapse. These results suggest that serum SPARC levels may be a potential biomarker for death but not cancer relapse.",2020,"On multivariate analyses adjusting serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy, patients with SPARC levels lower than the median level had a significantly higher risk for death than those with higher levels (hazard ratio, 2.25; 95% confidence interval, 1.25-4.05;  p  = 0.007), whereas there were no significant associations with other outcomes including recurrence.","['Patients with Digestive Tract Cancer', 'patients with stage I-III digestive tract cancer from the esophagus to the rectum (UMIN000001977']","['Serum SPARC Levels', 'postoperative oral vitamin D supplementation', 'placebo']","['recurrence', 'serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",,0.378942,"On multivariate analyses adjusting serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy, patients with SPARC levels lower than the median level had a significantly higher risk for death than those with higher levels (hazard ratio, 2.25; 95% confidence interval, 1.25-4.05;  p  = 0.007), whereas there were no significant associations with other outcomes including recurrence.","[{'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Akutsu', 'Affiliation': 'Division of Molecular Epidemiology, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo 105-8461, Japan.'}, {'ForeName': 'Eisaku', 'Initials': 'E', 'LastName': 'Ito', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Mitsuo', 'Initials': 'M', 'LastName': 'Narita', 'Affiliation': 'Department of Radiology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ohdaira', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo 105-8461, Japan.'}]",Cancers,['10.3390/cancers12061465']
1687,32513313,Dried fruit consumption and cardiometabolic health: a randomised crossover trial.,"Fruit intake is associated with lower risk of cardiometabolic diseases. However, effects of dried fruits on cardiometabolic health are not well researched. We investigated the effect of daily dried fruit consumption compared with a carbohydrate-rich snack on cardiometabolic disease risk factors in adults with increased cardiometabolic risk. A two-period randomised crossover trial was conducted in adults (n 55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup/d mixed dried fruits (plums, figs, dates and raisins) or an energy- and carbohydrate-matched control snack for 4 weeks. The primary outcome was LDL-cholesterol; secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure and vascular stiffness. Linear mixed models were used for data analysis. Lipid and lipoprotein concentrations did not differ between conditions; however, dried fruit increased LDL-cholesterol (0·10 mmol/l, 95 % CI 0·01, 0·20) compared with baseline. Compared with the control, dried fruit increased mean fasting glucose (0·08 mmol/l, 95 % CI 0·005, 0·16; P = 0·038). Vascular outcomes, fasting insulin and C-reactive protein did not differ between conditions. Mean weight changes did not differ (P = 0·55) but tended to increase after both conditions (dried fruit 0·3 kg, 95 % CI -0·09, 0·65; control 0·4 kg, 95 % CI 0·01, 0·75). Thus, short-term daily consumption of a large portion of mixed dried plums, figs, dates and raisins, without structured dietary guidance, did not improve cardiometabolic risk factors, compared with carbohydrate-rich snacks, in adults with increased baseline cardiometabolic risk.",2020,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","['adults (n=55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup', 'adults with increased cardiometabolic risk']","['dried fruits', 'daily dried fruit consumption', 'carbohydrate-rich snack', 'd mixed dried fruits (plums, figs, dates, and raisins) or a calorie- and carbohydrate-matched control snack']","['Dried fruit consumption and cardiometabolic health', 'cardiometabolic health', 'mean fasting glucose', 'Vascular outcomes, fasting insulin, and C-reactive protein', 'baseline cardiometabolic risk', 'Lipid and lipoprotein concentrations', 'Mean weight changes', 'cardiometabolic risk factors', 'low-density lipoprotein cholesterol (LDL-C); secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure, and vascular stiffness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0349966', 'cui_str': 'Figs'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",,0.0916874,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","[{'ForeName': 'Valerie K', 'Initials': 'VK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002007']
1688,32516182,Oblique versus longitudinal axis/in-plane approaches for ultrasound-guided radial arterial cannulation: A randomised controlled trial.,,2020,,[],['Oblique versus longitudinal axis/in-plane approaches for ultrasound-guided radial arterial cannulation'],[],[],"[{'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",[],,0.165901,,"[{'ForeName': 'Chao-Kun', 'Initials': 'CK', 'LastName': 'Zeng', 'Affiliation': 'From the Department of Anaesthesiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, PR China (Z-CK, Z-GF, D-JH, L-DW).'}, {'ForeName': 'Gao-Feng', 'Initials': 'GF', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jin-He', 'Initials': 'JH', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'De-Wei', 'Initials': 'DW', 'LastName': 'Li', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001186']
1689,32516959,Betaine Supplementation Does Not Improve Muscle Hypertrophy or Strength Following 6 Weeks of Cross-Fit Training.,"We aim to investigate the effect of 6 weeks of betaine supplementation on body composition and muscle performance during CrossFit© training. Twenty-nine subjects matched for training status (4.16 0.95 day/week) and body fat mass (12.66 4.08%) were randomly assigned to a betaine (BET; N = 14) or placebo group (PLA; N = 15). Body composition and cellular hydration were estimated with skinfolds measurement and bioelectrical impendence before and after 6 weeks of training. Muscle performance was assessed using three different tests: 3-RM back-squat for muscle strength, 2 km rowing test for aerobic capacity and Bergeron Beep Test for anaerobic capacity. Muscle strength assessed during back squat significantly increased in BET (p = 0.04) but not in the PLA group, however, there were no statistical differences between groups. Although not significant, fat mass was reduced in BET compared to PLA. Overall, body composition and cell hydration measurements did not change in response to training or betaine supplementation. Short-term (6 weeks) betaine supplementation supports muscle strength but was not ergogenic for trained subjects to aerobic and anaerobic performance in the CrossFit©-specific test.",2020,"Muscle strength assessed during back squat significantly increased in BET (p = 0.04) but not in the PLA group, however, there were no statistical differences between groups.",['Twenty-nine subjects matched for training status (4.16 0.95 day/week) and body fat mass (12.66 4.08'],"['placebo', 'betaine supplementation', 'Betaine Supplementation']","['Body composition and cellular hydration', 'Overall, body composition and cell hydration measurements', 'Muscle performance', 'Muscle Hypertrophy or Strength', 'body composition and muscle performance', 'fat mass', 'Muscle strength assessed during back squat significantly increased in BET']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}]",29.0,0.086445,"Muscle strength assessed during back squat significantly increased in BET (p = 0.04) but not in the PLA group, however, there were no statistical differences between groups.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Moro', 'Affiliation': 'Department of Biomedical Science, University of Padova, 35100 Padova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Badiali', 'Affiliation': 'iF srl Faenza, \u200e48100 Ravenna, Italy.'}, {'ForeName': 'Iader', 'Initials': 'I', 'LastName': 'Fabbri', 'Affiliation': 'iF srl Faenza, \u200e48100 Ravenna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Paoli', 'Affiliation': 'Department of Biomedical Science, University of Padova, 35100 Padova, Italy.'}]",Nutrients,['10.3390/nu12061688']
1690,32519507,Role of vitamin D in oxidative stress modulation in end-stage renal disease patients: A double-blind randomized clinical trial.,"INTRODUCTION


Oxidative stress is considered as important actor in uremia-associated morbidity and mortality in hemodialysis (HD) patients. We aimed to evaluate the role of vitamin D supplementation on oxidative stress parameters in this group.
METHODS


This double-blind randomized clinical trial was conducted on HD patients who were randomly allocated into intervention (n = 40) or control groups (n = 38) for 10 weeks. Blood samples were taken before and at the end of the trial to measure serum 25-hydroxyvitamin D (25(OH)D), malondialdehyde (MDA), glutathione peroxidase (GPx), catalase (CAT), and superoxide dismutase (SOD). Data were analyzed using SPSS, and P value <0.05 was considered to be statistically significant.
FINDINGS


Out of the 78 patients with a mean age of 44.7 ± 13.0 years, 55.1% were men. At the commencement of the study, there was no difference with respect to serum 25(OH)D levels in our groups (P = 0.575), but during the study it was significantly elevated in the intervention group (18.1 ± 9.1 vs. 31.7 ± 12.9, P < 0.0001). Serum antioxidative enzymes activity (GPx, CAT, and SOD) had significantly increased after vitamin D supplementation in the intervention group (P < 0.05). Furthermore, MDA levels was significantly reduced only in the intervention group (31.7 ± 18.0 vs. 24.7 ± 7.7, P = 0.018).
DISCUSSION


Regular consumption of vitamin D can increase the GPx, CAT, SOD, and reduce the MDA plasma levels in HD patients. Since no adverse effects of vitamin D supplementation was reported by the patients; hence, it can be prescribed for HD patients.",2020,"Regular consumption of vitamin D can increase the GPx, CAT, SOD, and reduce the MDA plasma levels in HD patients.","['end-stage renal disease patients', 'HD patients who were randomly allocated into intervention (n =\u200940) or control groups (n =\u200938) for 10\u2009weeks', '78 patients with a mean age of 44.7\u2009±\u200913.0\u2009years, 55.1% were men', 'HD patients', 'hemodialysis (HD) patients']","['vitamin D', 'vitamin D supplementation']","['Serum antioxidative enzymes activity (GPx, CAT, and SOD', 'oxidative stress parameters', 'serum 25-hydroxyvitamin D (25(OH)D), malondialdehyde (MDA), glutathione peroxidase (GPx), catalase (CAT), and superoxide dismutase (SOD', 'MDA plasma levels', 'MDA levels', 'serum 25(OH)D levels']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",78.0,0.151614,"Regular consumption of vitamin D can increase the GPx, CAT, SOD, and reduce the MDA plasma levels in HD patients.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Malekmakan', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mansourian', 'Affiliation': 'Department of Anesthesiology, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Pakfetrat', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Roozbeh', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khojaste', 'Initials': 'K', 'LastName': 'Rahimi Jaberi', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12849']
1691,32522503,"Sensory aspects of acceptability of bitter-flavoured 7.5 mm film-coated tablets in adults, preschool and school children.","There is great interest in demonstrating acceptability of solid oral formulations in paediatric populations. This study investigated the acceptability of small, 7.5 mm, bitter-flavoured, coated tablets in healthy children and adults. A randomised, double-blind acceptability test was performed involving 101 children (4-12 years) and 52 adults (18-75 years). Acceptability was measured by participants as sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions. Additionally, the taste-masking effect of film coatings was assessed based on the intensity of bitterness perception. At least one tablet was voluntarily swallowed by 35.7% of 4-6-year olds, 74% of 7-12-year olds and 98% of adults. The bitterness of the tablet did not affect participants' ability to swallow it. The sensory properties determined whether the tablet was acceptable. The following factors: low bitterness, high smoothness, high slipperiness and pleasant aftertaste had a positive impact on overall palatability in both populations. The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability. This study demonstrates the multifactorial nature of palatability of tablets and highlights that adults' palatability evaluation cannot be directly translated to a paediatric population.",2020,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","['healthy children and adults', 'adults, preschool and school children', '101 children (4-12 years) and 52 adults (18-75 years']",['bitter-flavoured 7.5 mm film-coated tablets'],"['overall palatability', 'Acceptability', 'sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",101.0,0.21376,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","[{'ForeName': 'Justyna Katarzyna', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: h.k.batchelor@bham.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119511']
1692,32505866,"Compared to Facebook, Instagram use causes more appearance comparison and lower body satisfaction in college women.","The current experiment tested the effect of social media use on college women's appearance comparisons, mood, and body satisfaction. We randomly assigned 308 undergraduate women (aged 18-26) to use Facebook, use Instagram, or play a matching game (the control condition) on an iPad for seven minutes. Compared to the Facebook condition, Instagram users retrospectively reported spending more time viewing images or videos containing people. Participants in both the Facebook and Instagram conditions also retrospectively reported engaging in more appearance comparisons relative to those in the control condition, but Instagram users reported significantly more appearance comparisons than those in the Facebook condition. Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect. Results are consistent with previous research suggesting social media use influences body satisfaction and social comparison, and that Instagram may be a particularly harmful platform when it comes to body image because of its focus on photos over text.",2020,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[""college women's"", '308 undergraduate women (aged 18-26) to use', 'college women']","['Facebook, use Instagram, or play a matching game (the control condition']","['body satisfaction', 'appearance comparisons, mood, and body satisfaction']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",308.0,0.0383295,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Engeln', 'Affiliation': 'Department of Psychology, Northwestern University, United States. Electronic address: rengeln@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Loach', 'Affiliation': 'Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Imundo', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zola', 'Affiliation': 'Oxford Internet Institute, University of Oxford, United Kingdom.'}]",Body image,['10.1016/j.bodyim.2020.04.007']
1693,32505867,Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators are equivalent in the assessment of photosensitivity: Clinical and research implications.,"The assessment of the effect of photic stimulation is an integral component of an EEG exam and is especially important in patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy. A positive test result relies on eliciting a specific abnormality defined as the ""photoparoxysmal response"". Reliability of this assessment is strongly influenced by technical and procedural variables, a critical one represented by the physical properties of the stimulators used. Established clinical norms are based on data acquired with the ""gold-standard"" Grass PS stimulators. These are no longer commercially available and have been replaced by stimulators using light emitting diode (LED) technology. To our knowledge no comparative study on their efficacy has been conducted. To address this gap, we recruited 39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity in a prospective randomized single-blind cross-over study to compare two commercially available LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device. Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.",2020,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"['39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity', 'patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy']","['Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators', 'LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device', 'photic stimulation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0014548', 'cui_str': 'Generalized epilepsy'}, {'cui': 'C0349506', 'cui_str': 'Photosensitivity'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]",[],39.0,0.0265254,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"[{'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center Utrecht, Utrecht, the Netherlands; Nesmos Department, Faculty of Medicine and Psychology, Sapienza University, Roma, Italy.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Checa-Ros', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK; Department of Pediatrics, Faculty of Medicine, University of Granada, Spain.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Seri', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK. Electronic address: s.seri@aston.ac.uk.""}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106377']
1694,32512513,The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.,"BACKGROUND


Craving is a central feature of addiction. Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder (OUD). However, trials in large populations of patients with OUDs are lacking.
METHODS


We randomly assigned 118 male heroin patients into three groups (i.e., 10 Hz rTMS, 1 Hz rTMS and a wait-list control group) from two addiction rehabilitation centers. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 daily consecutive sessions.
FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group. The treatment effects lasted for up to 60 days after rTMS treatment cessation.
INTERPRETATION


Our results suggest that rTMS applied to the DLPFC is effective in reducing craving severity in heroin use disorder patients. Our results also suggest that such treatment effects can last for up to 60 days after treatment cessation.",2020,"FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","['male patients with heroin use disorder', '118 male heroin patients into three groups (i.e., 10', 'heroin use disorder patients', 'patients with opioid use disorder (OUD']","['repetitive transcranial magnetic stimulation', 'rTMS', 'Hz rTMS, 1\u202fHz rTMS and a wait-list control group) from two addiction rehabilitation centers']","['cue-induced craving scores', 'craving severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",118.0,0.0241904,"FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China; Ningbo Key Laboratory of Sleep Medicine, Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT, U.S.A.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, U.S.A.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, U.S.A.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, China; Key Laboratory of Brain and Cognitive Neurosience, Liaoning Province, China. Electronic address: luowb@lnnu.edu.cn.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ont., Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102809']
1695,32512517,Association between cellular HIV-1 DNA level and mortality in HIV-1 infected African adults starting ART with high CD4 counts.,"BACKGROUND


High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa.
METHODS


In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality.
FINDINGS


2019 patients were followed for 9253 patient-years (median 4.9 years). At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3]. During follow-up, 86 participants died. In univariate analysis, the hazard ratio [HR] of death was 2.67 (95% CI, 1.68-4.22) for patients with HIV-1 DNA ≥3 log 10  copies/million PBMC vs. others, and 2.10 (95% CI, 1.38-3.21) for patients with HIV-1 RNA ≥5 log10 copies/ml vs. others. In multivariate Cox regression analysis, HIV-1 DNA levels ≥3 log 10  copies/million PBMC were strongly associated mortality (adjusted HR = 2.09, 95% CI 1.24-3.52, p= 0.005) while the association between baseline plasma HIV-1 RNA and mortality was not significant.
INTERPRETATION


In these African adults who started ART with high CD4 counts, HIV-1 DNA was a strong independent predictor of death. The HIV reservoir still plays a prognostic role in the early ART era.
FUNDING


This trial was supported by the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France; Grants ANRS 12136, 12224 and 12253).",2020,"At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3].","['HIV-infected adults in a trial of early ART in West Africa', '2019 patients were followed for 9253 patient-years (median 4.9 years', 'HIV-infected adults', 'HIV-1 infected African adults starting ART with high CD4 counts']",[],"['median plasma HIV-1 RNA', 'hazard ratio [HR] of death', 'HIV-1 DNA and mortality', 'HIV-1 DNA', 'mortality', 'median CD4 count', 'baseline plasma HIV-1 RNA and mortality', 'CD4 count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2019.0,0.300537,"At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3].","[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': ""N'takpe"", 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire. Electronic address: jean-baptiste.ntakpe@u-bordeaux.fr.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gardiennet', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Emieme', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': ""Thomas-d'Aquin"", 'Initials': 'TD', 'LastName': 'Toni', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Jérome Le', 'Initials': 'JL', 'LastName': 'Carrou', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ménan', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': ""PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102815']
1696,32513581,Effects of soy isoflavones on serum lipids and lipoprotein (a) in peritoneal dialysis patients.,"BACKGROUND AND AIM


Lipid abnormalities are common in peritoneal dialysis (PD) patients and no effective treatment to decrease serum lipoprotein (a) [Lp(a)] in dialysis patients is known so far. Therefore, this research was designed to investigate the effects of soy isoflavone supplement on serum lipids and Lp(a) in PD patients.
METHODS & RESULTS


In this randomized, double-blind, placebo-controlled trial, 40 PD patients were randomly assigned to either the isoflavone or the placebo group. The patients in the isoflavone group received 100 mg soy isoflavone daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of the 8th week, 7 mL of blood was obtained from each patient and serum triglycerides, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and Lp(a) were measured. Serum Lp(a) reduced significantly up to 10% in the isoflavone group at the end of week 8 compared to baseline (P < 0.05), and the reduction was significant in comparison with the placebo group (P < 0.05). Serum HDL-C increased significantly up to 11.5% in the isoflavone group at the end of week 8 compared to baseline (P = 0.05), and the increment was significant in comparison with the placebo group (P < 0.05). There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C.
CONCLUSIONS


This study indicates that daily administration of 100 mg soy isoflavones reduces serum Lp(a) and increases HDL-C concentration which are two determinants of cardiovascular disease in PD patients. CLINICALTRIALS.GOV: NCT03773029.
REGISTRATION NUMBER AND DATE


NCT03773029 - 2018.",2020,"There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C.
","['peritoneal dialysis (PD) patients', 'PD patients', 'peritoneal dialysis patients', '40 PD patients']","['soy isoflavone supplement', 'placebos', 'isoflavone', '100\xa0mg soy isoflavones', 'soy isoflavones', '100\xa0mg soy isoflavone', 'placebo']","['serum lipoprotein (a) [Lp(a', 'HDL-C concentration', 'mean changes of serum triglycerides, total cholesterol, and LDL-C', 'Serum Lp(a', 'serum lipids and lipoprotein (a', 'Serum HDL-C', 'serum triglycerides, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and Lp(a', 'serum Lp(a', 'serum lipids and Lp(a']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",40.0,0.329101,"There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: zahrayari_nut@yahoo.com.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tabibi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: hadtabibi@yahoo.com.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Najafi', 'Affiliation': 'Department of Nephrology, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: NAJAFI63800@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: Hedayati@endocrine.ac.ir.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: nutritionist1993@gmail.com.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.023']
1697,32521358,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE


Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
METHODS


The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.
ETHICS AND DISSEMINATION


The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132']
1698,32521394,Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.,"OBJECTIVE


Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty.
PATIENTS AND METHODS


Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device.
RESULTS


VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups.
CONCLUSIONS


Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.",2020,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","['patients undergoing posterior spinal fusion surgery', 'Eighty patients who underwent posterior spinal fusion', 'patients undergoing posterior lumbar spinal fusion surgery']","['Perioperative magnesium sulfate infusion', 'magnesium and saline', 'magnesium', 'perioperative magnesium sulfate infusion']","['postoperative analgesia', 'intraoperative bleeding', 'Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen', 'morphine consumption', 'cell count, magnesium concentration and coagulation status', 'Morphine consumption', 'intraoperative blood loss', 'pain score', 'activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT', 'Cumulative PCA morphine consumption', 'intraoperative blood loss and postoperative analgesia', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",80.0,0.140799,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","[{'ForeName': 'Masih Ebrahimy', 'Initials': 'ME', 'LastName': 'Dehkordy', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Tavanaei', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Younesi', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khorasanizade', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza Azizi', 'Initials': 'HA', 'LastName': 'Farsani', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraee-Yazdani', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Saeed_o_yazdani@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105983']
1699,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1700,32521472,Improvement of dynamic postural stability by an exercise program.,"BACKGROUND


Central processing of multi-sensory feedback and motor commands responsible for force production are critical for postural control. An exercise program was developed to realign spinal curvature, but its effect on postural control is unknown.
RESEARCH QUESTION


To what extent would the exercise program influence on center of pressure (CoP) sway on stable and unstable surfaces?
METHODS


Subjects (n = 30) were randomly assigned into one of three groups: exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n = 10), exercise on a flat surface (n = 10), and a control group that laid supine on a flat surface (n = 10). Standing posture of each subject was quantified using anterior-, posterior-, and lateral-view photography. Each subject's CoP sway was measured while standing on a static and dynamic platform with eyes open and eyes closed. Subjects were instructed to stand still when the platform was held stationary (e.g., no tilt) during the static condition. During the dynamic condition the platform was allowed to tilt in response to changes of CoP and subjects were instructed to maintain the platform in a horizontal position.
RESULTS


Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
SIGNIFICANCE


It is speculated that performing the exercise program on the tube might enhance a) central processing of somatosensory and vestibular inputs, b) motor commands responsible for force production in postural control, and c) biomechanical advantage by the realigned posture. The exercise program can be used by a variety of populations as home-exercise to realign the neck and pelvic posture and improve dynamic postural stability.",2020,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
",['Subjects (n\u202f=\u202f30'],"['exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n\u202f=\u202f10), exercise on a flat surface (n\u202f=\u202f10), and a control group that laid supine']","['dynamic postural stability', 'neck flexion and pelvis tilt decreased, and CoP sway']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0135493,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibata', 'Affiliation': 'Athletic Training Education Program, Department of Health Exercise and Sports Sciences, University of New Mexico, New Mexico, USA. Electronic address: diceshibata@unm.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.044']
1701,31816075,"Morning Bright Light Treatment for Chronic Low Back Pain: Potential Impact on the Volatility of Pain, Mood, Function, and Sleep.","OBJECTIVES


Most treatment outcome studies for people with chronic low back pain (CLBP) have based analyses on and reported only the mean levels of these factors. However, high levels of pain, mood, function, and sleep volatility may represent unique factors contributing to diminished quality of life. Our goal was to determine whether bright light treatment affected both mean levels of pain, mood, function, and sleep and reduced volatility in these outcomes.
METHODS


US military veterans with CLBP (N = 22) underwent an open trial with a seven-day baseline, followed by 13 days of a one-hour morning bright light treatment self-administered at their home and a 30-day follow-up. Participants completed daily diary measures at 12 Pm and 6 Pm every day during the three study epochs.
RESULTS


Using location scale modeling, results suggested that, in addition to being associated with changes in mean levels of pain intensity, pain interference, negative affect, and sleep quality, bright light treatment was also related to reductions in the volatility of pain intensity and negative affect, reductions that were largely maintained during follow-up.
CONCLUSIONS


Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares."" These findings underscore the potential importance of volatility as a future treatment target.",2020,"CONCLUSIONS


Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares.","['US military veterans with CLBP (N\u2009=\u200922', 'people with chronic low back pain (CLBP', 'Chronic Low Back Pain']",['Morning Bright Light Treatment'],"['volatility of pain intensity', 'daily diary measures', 'pain flares', 'mean levels of pain intensity, pain interference, negative affect, and sleep quality', 'mean levels of pain, mood, function, and sleep and reduced volatility']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1959569', 'cui_str': 'Volatility'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",22.0,0.0561542,"CONCLUSIONS


Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gerhart', 'Affiliation': 'Department of Psychology, Central Michigan University, Mount Pleasant, Michigan.'}, {'ForeName': 'Muneer', 'Initials': 'M', 'LastName': 'Rizvydeen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz235']
1702,32526225,The effect of HF-rTMS over the left DLPFC on stress regulation as measured by cortisol and heart rate variability.,"The prefrontal cortex, and especially the Dorsolateral Prefrontal Cortex (DLPFC), plays an inhibitory role in the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis under stressful situations. Moreover, recent evidence suggests that a sustained DLPFC activation is associated with adaptive stress regulation in anticipation of a stressful event, leading to a reduced stress-induced amygdala response, and facilitating the confrontation with the stressor. However, studies using experimental manipulation of the activity of the DLPFC before a stressor are scarce, and more research is needed to understand the specific role of this brain area in the stress-induced physiological response. This pre-registered study investigated the effect on stress regulation of a single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session over the left DLPFC applied before the Trier Social Stress Test in 75 healthy young women (M = 21.05, SD = 2.60). Heart rate variability (HRV) and salivary cortisol were assessed throughout the experimental protocol. The active HF-rTMS and the sham group showed a similar cognitive appraisal of the stress task. No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments. Importantly, participants in the active HF-rTMS group showed a lower cortisol response to stress. The effect of left prefrontal HF-rTMS on the stress system provides further critical experimental evidence for the inhibitory role played by the DLPFC in the regulation of the HPA axis.",2020,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","['75 healthy young women (M\u202f=\u202f21.05, SD\u202f=\u202f2.60']","['single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session', 'HF-rTMS']","['HRV', 'cortisol response', 'Heart rate variability (HRV) and salivary cortisol']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",75.0,0.0262171,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","[{'ForeName': 'Matias M', 'Initials': 'MM', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: matias.pulopulos@ugent.be.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schmausser', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Baliyan', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Venero', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium; Department of Psychiatry, University Hospital Brussels (UZBrussel), Belgium; Department of Electrical Engineering, Eindhoven University of Technology, the Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104803']
1703,32527972,Endovascular treatment in older adults with acute ischemic stroke in the MR CLEAN Registry.,"OBJECTIVE


To explore clinical outcomes in older adults with acute ischemic stroke treated with endovascular thrombectomy (EVT).
METHODS


We included consecutive patients (2014-2016) with an anterior circulation occlusion undergoing EVT from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry. We assessed the effect of age (dichotomized at ≥80 years and as continuous variable) on the modified Rankin Scale (mRS) score at 90 days, symptomatic intracranial hemorrhage (sICH), and reperfusion rate. The association between age and mRS was assessed with multivariable ordinal logistic regression, and a multiplicative interaction term was added to the model to assess modification of reperfusion by age on outcome.
RESULTS


Of the 1,526 patients, 380 (25%) were ≥80 years of age (referred to here as older adults). Older adults had a worse functional outcome than younger patients (adjusted common odds ratio [acOR] for an mRS score shift toward better outcome 0.31, 95% confidence interval [CI] 0.24-0.39). Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19). There were no differences in proportion of patients with mRS scores of 4 to 5, sICH, or reperfusion rates. Successful reperfusion was more strongly associated with a shift toward good functional outcome in older adults than in younger patients (acOR 3.22, 95% CI 2.04-5.10 vs 2.00, 95% CI 1.56-2.57,  p   interaction  = 0.026).
CONCLUSION


Older age is associated with an increased absolute risk of poor clinical outcome, while the relative benefit of successful reperfusion seems to be higher in these patients. These results should be taken into consideration in the selection of older adults for EVT.",2020,"Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19).","['older adults with acute ischemic stroke treated with endovascular thrombectomy (EVT', 'Older adults', 'consecutive patients (2014-2016) with an anterior circulation occlusion undergoing EVT from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry', 'older adults with acute ischemic stroke in the MR CLEAN Registry', '1,526 patients, 380 (25%) were ≥80 years of age (referred to here as older adults']",['Endovascular treatment'],"['proportion of patients with mRS scores of 4 to 5, sICH, or reperfusion rates', 'Mortality', 'modified Rankin Scale (mRS) score at 90 days, symptomatic intracranial hemorrhage (sICH), and reperfusion rate', 'functional outcome']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.144124,"Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19).","[{'ForeName': 'Adrien E', 'Initials': 'AE', 'LastName': 'Groot', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Ivo G H', 'Initials': 'IGH', 'LastName': 'Jansen', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Hinsenveld', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'van de Graaf', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Hanna C', 'Initials': 'HC', 'LastName': 'Willems', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Schonewille', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Marquering', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van den Berg', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands. j.coutinho@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009764']
1704,32511937,The effect of high vs. low intensity neuropsychological treatment on working memory in patients with acquired brain injury.,"AIM


To evaluate the combined effect of compensation therapy and functional training on working memory (WM) in patients with acquired injury and chronic cognitive deficits by investigating the dose-response relationship and specificity of transfer effects.
RESEARCH DESIGN


Double-blind randomized controlled trial.
METHODS


All patients underwent 4 weeks of compensation therapy in a day-care setting. In addition, they received either 20 sessions of computer-based WM training (n = 11) or attention training (n = 9). Transfer effects on cognition and their functional relevance in daily life were assessed before treatment, after 2 weeks (10 additional training sessions), and after 4 weeks (20 additional training sessions) of therapy.
RESULTS


The combined treatment led to significant improvements in WM performance, verbal memory, and self-reported changes in daily life. The amount of training was identified to modulate efficacy: Significant improvements showed only in the later training phase. We observed no differences between the two training schemes (WM vs. attentional training).
CONCLUSIONS


Even in the chronic phase after brain lesion WM performance can be enhanced by the combination of compensation therapy and computerized cognitive training when applied intensely; both a more general attention and a specific WM training regimen are effective.",2020,Even in the chronic phase after brain lesion WM performance can be enhanced by the combination of compensation therapy and computerized cognitive training when applied intensely; both a more general attention and a specific WM training regimen are effective.,"['patients with acquired brain injury', 'patients with acquired injury and chronic cognitive deficits']","['compensation therapy and functional training', 'computer-based WM training (n\xa0=\xa011) or attention training', 'compensation therapy', 'high vs. low intensity neuropsychological treatment']","['working memory (WM', 'cognition and their functional relevance in daily life', 'WM performance, verbal memory, and self-reported changes in daily life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0373474,Even in the chronic phase after brain lesion WM performance can be enhanced by the combination of compensation therapy and computerized cognitive training when applied intensely; both a more general attention and a specific WM training regimen are effective.,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Weicker', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hudl', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences , Leipzig, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Psychology, Carl Von Ossietzky University of Oldenburg , Oldenburg, Germany.'}, {'ForeName': 'Hellmuth', 'Initials': 'H', 'LastName': 'Obrig', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Psychology, Carl Von Ossietzky University of Oldenburg , Oldenburg, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Villringer', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Thöne-Otto', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}]",Brain injury,['10.1080/02699052.2020.1773536']
1705,32511981,"Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Resistance to approved inhibitors of KIT proto-oncogene, receptor tyrosine kinase (KIT), and platelet-derived growth factor receptor α (PDGFRA) is a clinical challenge for patients with advanced gastrointestinal stromal tumours. We compared the efficacy and safety of ripretinib, a switch-control tyrosine kinase inhibitor active against a broad spectrum of KIT and PDGFRA mutations, with placebo in patients with previously treated, advanced gastrointestinal stromal tumours.
METHODS


In this double-blind, randomised, placebo-controlled, phase 3 study, we enrolled adult patients in 29 specialised hospitals in 12 countries. We included patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Eligible patients were randomly assigned (2:1) to receive either oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo group). Randomisation was done via an interactive response system using randomly permuted block sizes of six and stratified according to number of previous therapies and ECOG performance status. Patients, investigators, research staff, and the sponsor study team were masked to a patient's treatment allocation until the blinded independent central review (BICR) showed progressive disease for the patient. The primary endpoint was progression-free survival, assessed by BICR. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of study drug. Patients randomly assigned to placebo were permitted to cross over to ripretinib 150 mg at the time of disease progression. The INVICTUS study is registered with ClinicalTrials.gov, number NCT03353753, and with WHO International Clinical Trials Registry Platform, number EUCTR2017-002446-76-ES; follow-up is ongoing.
FINDINGS


Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients were randomly assigned to receive either ripretinib (n=85) or placebo (n=44). At data cutoff (May 31, 2019), at a median follow-up of 6·3 months (IQR 3·2-8·2) in the ripretinib group and 1·6 months (1·1-2·7) in the placebo group, 51 patients in the ripretinib group and 37 in the placebo group had had progression-free survival events. In the double-blind period, median progression-free survival was 6·3 months (95% CI 4·6-6·9) with ripretinib compared with 1·0 months (0·9-1·7) with placebo (hazard ratio 0·15, 95% CI 0·09-0·25; p<0·0001). The most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events in the ripretinib group (n=85) included lipase increase (four [5%]), hypertension (three [4%]), fatigue (two [2%]), and hypophosphataemia (two (2%]); in the placebo group (n=43), the most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events were anaemia (three [7%]), fatigue (one [2%]), diarrhoea (one [2%]), decreased appetite (one [2%]), dehydration (one [2%]), hyperkalaemia (one [2%]), acute kidney injury (one [2%]), and pulmonary oedema (one [2%]). Treatment-related serious adverse events were reported in eight (9%) of 85 patients who received ripretinib and three (7%) of 43 patients who received placebo. Treatment-related deaths occurred in one patient in the placebo group (septic shock and pulmonary oedema) and one patient in the ripretinib group (cause of death unknown; the patient died during sleep).
INTERPRETATION


Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
FUNDING


Deciphera Pharmaceuticals.",2020,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
","['enrolled adult patients in 29 specialised hospitals in 12 countries', 'patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2', 'patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments', 'Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients', 'patients with previously treated, advanced gastrointestinal stromal tumours', 'patients with advanced gastrointestinal stromal tumours (INVICTUS', 'patients with advanced gastrointestinal stromal tumours', 'Eligible patients']","['ripretinib', 'oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo', 'placebo']","['lipase increase', 'median progression-free survival', 'progression-free survival events', 'intention-to-treat population and safety', 'fatigue', 'hyperkalaemia', 'acute kidney injury', 'septic shock and pulmonary oedema', 'diarrhoea', 'dehydration', 'serious adverse events', 'pulmonary oedema', 'hypertension', 'deaths', 'decreased appetite', 'progression-free survival, assessed by BICR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549475', 'cui_str': 'Lipase increased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.788248,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
","[{'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France; Headquarters, Unicancer, Paris, France; LYRICAN, Lyon, France; Faculte Lyon Est, Université Claude Bernard, Lyon, France. Electronic address: jean-yves.blay@lyon.unicancer.fr.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Serrano', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine, Portland VA Health Care System, Portland, OR, USA; OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology and Preventative Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen, Essen, Germany; German Consortium for Translational Cancer Research (DKTK), Partner Site Essen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Leuven Cancer Institute and Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, The Royal Marsden NHS Foundation Trust, London, UK; Division of Clinical Studies, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Department of Oncology, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Meade', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ruiz-Soto', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Department of Hematology and Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30168-6']
1706,32512067,Comparison of the Biocidal Efficacy of Sodium Dichloroisocyanurate and Calcium Hydroxide as Intracanal Medicaments over a 7-Day Contact Time: An Ex Vivo Study.,"INTRODUCTION


The use of medicaments has been recommended for the treatment of root canal infection. This study evaluated the antimicrobial effect of a well-known biocidal agent, sodium dichloroisocyanurate (NaDCC), by comparing it with calcium hydroxide [Ca(OH) 2 ] using an engineered 3-species biofilm root canal model.
METHODS


Thirty-eight human single-rooted teeth were decoronated and chemomechanically prepared before inoculation using Enterococcus faecalis, Actinomyces viscosus, and Streptococcus mutans using a flow cell model for 4 weeks for biofilm formation. The samples were randomly divided into 3 groups: NaDCC (n = 12), Ca(OH) 2  (n = 12), and positive control (no medicament, n = 14). The medicaments were placed using a Lentulo spiral. After a contact time of 7 days, the roots were crushed and plated on selective media. Bacterial identities were confirmed with the use of selective media. Colony-forming units were calculated (CFU/ml). Descriptive statistics (mean and standard deviations) were calculated.
RESULTS


Seven-day dressing with NaDCC or Ca(OH) 2  presented with no growth. For the positive control, the mean colony-forming units were 2.97E4 ± 3.42E4 (CFU/ml). All previously inoculated strains were recovered in the control group.
CONCLUSIONS


NaDCC and Ca(OH) 2  when used as intracanal medicaments were able to eradicate an engineered 3-species biofilm in single-rooted teeth in an ex vivo model. NaDCC deserves further investigation as an intracanal medicament.",2020,"CONCLUSIONS


NaDCC and Ca(OH) 2  when used as an intracanal medicaments were able to eradicate an engineered three-species biofilm in single-rooted teeth, ex-vivo model.",['ology: 38 human single-rooted teeth'],"['NaDCC or Ca(OH', 'calcium hydroxide (Ca(OH', 'sodium dichloroisocyanurate and calcium hydroxide', 'well-known biocidal agent, sodium dichloroisocyanurate (NaDCC', 'Ca(OH) 2  (n=12) and positive control (no medicament', 'NaDCC']",['Descriptive statistics [mean and standard deviations (SD'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0142834', 'cui_str': 'Sodium dichloroisocyanurate'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456386', 'cui_str': 'Medicament'}]","[{'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",,0.0118599,"CONCLUSIONS


NaDCC and Ca(OH) 2  when used as an intracanal medicaments were able to eradicate an engineered three-species biofilm in single-rooted teeth, ex-vivo model.","[{'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Neelika Roy', 'Initials': 'NR', 'LastName': 'Chowdhury', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia; Private Practice, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zilm', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Rossi-Fedele', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia. Electronic address: giampiero.rossi-fedele@adelaide.edu.au.'}]",Journal of endodontics,['10.1016/j.joen.2020.05.011']
1707,32516282,"Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2).","BACKGROUND


Baloxavir marboxil (baloxavir) is a novel, cap-dependent endonuclease inhibitor that has previously demonstrated efficacy in the treatment of influenza in adults and adolescents. We assessed the safety and efficacy of baloxavir in otherwise healthy children with acute influenza.
METHODS


MiniSTONE-2 (Clinicaltrials.gov: NCT03629184) was a double-blind, randomized, active controlled trial enrolling children 1-<12 years old with a clinical diagnosis of influenza. Children were randomized 2:1 to receive either a single dose of oral baloxavir or oral oseltamivir twice daily for 5 days. The primary endpoint was incidence, severity and timing of adverse events (AEs); efficacy was a secondary endpoint.
RESULTS


In total, 173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group. Characteristics of participants were similar between treatment groups. Overall, 122 AEs were reported in 84 (48.6%) children. Incidence of AEs was similar between baloxavir and oseltamivir groups (46.1% vs. 53.4%, respectively). The most common AEs were gastrointestinal (vomiting/diarrhea) in both groups [baloxavir: 12 children (10.4%); oseltamivir: 10 children (17.2%)]. No deaths, serious AEs or hospitalizations were reported. Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir.
CONCLUSIONS


Oral baloxavir is well tolerated and effective at alleviating symptoms in otherwise healthy children with acute influenza. Baloxavir provides a new therapeutic option with a simple oral dosing regimen.",2020,"Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir.
","['otherwise healthy children with acute influenza', 'children 1-<12 years old with a clinical diagnosis of influenza', 'adults and adolescents', '12 children (10.4', 'Influenza-infected Children', '10 children (17.2', '173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group']","['oseltamivir', 'Baloxavir', 'baloxavir', 'Baloxavir Marboxil Single-dose Treatment', 'oral baloxavir or oral oseltamivir', 'Baloxavir marboxil (baloxavir']","['alleviation of signs and symptoms of influenza', 'incidence, severity and timing of adverse events (AEs); efficacy', 'No deaths, serious AEs or hospitalizations', 'safety and efficacy', 'Incidence of AEs', 'Median time', 'gastrointestinal (vomiting/diarrhea']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",173.0,0.517593,"Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir.
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'From the Clinical Research Prime, Idaho Falls, Idaho.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Block', 'Affiliation': 'Kentucky Pediatric and Adult Research Inc., Bardstown, Kentucky.'}, {'ForeName': 'Balpreet', 'Initials': 'B', 'LastName': 'Matharu', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Burleigh Macutkiewicz', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wildum', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dimonaco', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Collinson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Clinch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Piedra', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002747']
1708,32525525,Metabolic Effects of Late Dinner in Healthy Volunteers-A Randomized Crossover Clinical Trial.,"CONTEXT


Consuming calories later in the day is associated with obesity and metabolic syndrome. We hypothesized that eating a late dinner alters substrate metabolism during sleep in a manner that promotes obesity.
OBJECTIVE


The objective of this work is to examine the impact of late dinner on nocturnal metabolism in healthy volunteers.
DESIGN AND SETTING


This is a randomized crossover trial of late dinner (LD, 22:00) vs routine dinner (RD, 18:00), with a fixed sleep period (23:00-07:00) in a laboratory setting.
PARTICIPANTS


Participants comprised 20 healthy volunteers (10 male, 10 female), age 26.0 ± 0.6 years, body mass index 23.2 ± 0.7 kg/m2, accustomed to a bedtime between 22:00 and 01:00.
INTERVENTIONS


An isocaloric macronutrient diet was administered on both visits. Dinner (35% daily kcal, 50% carbohydrate, 35% fat) with an oral lipid tracer ([2H31] palmitate, 15 mg/kg) was given at 18:00 with RD and 22:00 with LD.
MAIN OUTCOME MEASURES


Measurements included nocturnal and next-morning hourly plasma glucose, insulin, triglycerides, free fatty acids (FFAs), cortisol, dietary fatty acid oxidation, and overnight polysomnography.
RESULTS


LD caused a 4-hour shift in the postprandial period, overlapping with the sleep phase. Independent of this shift, the postprandial period following LD was characterized by higher glucose, a triglyceride peak delay, and lower FFA and dietary fatty acid oxidation. LD did not affect sleep architecture, but increased plasma cortisol. These metabolic changes were most pronounced in habitual earlier sleepers determined by actigraphy monitoring.
CONCLUSION


LD induces nocturnal glucose intolerance, and reduces fatty acid oxidation and mobilization, particularly in earlier sleepers. These effects might promote obesity if they recur chronically.",2020,"LD did not affect sleep architecture, but increased plasma cortisol.","['Healthy Volunteers', 'healthy volunteers', '20 healthy volunteers (10 males, 10 females), aged 26.0 ± 0.6 years, BMI 23.2 ± 0.7 kg/m2, accustomed to a bedtime between 22:00-01:00']","['late dinner', 'isocaloric macronutrient diet', 'Late Dinner', 'oral lipid tracer ([2H31] palmitate']","['fatty acid oxidation and mobilization', 'triglyceride peak delay, and lower FFA and dietary fatty acid oxidation', 'hourly plasma glucose, insulin, triglycerides, free fatty acids (FFAs), cortisol, dietary fatty acid oxidation, and overnight polysomnography', 'Nocturnal and next-morning', 'plasma cortisol', 'nocturnal glucose intolerance', 'nocturnal metabolism']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",20.0,0.0402215,"LD did not affect sleep architecture, but increased plasma cortisol.","[{'ForeName': 'Chenjuan', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Brereton', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schweitzer', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cotter', 'Affiliation': ""Arkansas Children's Nutrition Center, Arkansas Children's Research Institute, Little Rock, Arkansas.""}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Duan', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Børsheim', 'Affiliation': ""Arkansas Children's Nutrition Center, Arkansas Children's Research Institute, Little Rock, Arkansas.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Pediatrics, The University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Luu V', 'Initials': 'LV', 'LastName': 'Pham', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Vsevolod Y', 'Initials': 'VY', 'LastName': 'Polotsky', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Jun', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa354']
1709,32526669,A CT-based deep learning model for predicting the nuclear grade of clear cell renal cell carcinoma.,"PURPOSE


To investigate the effects of different methodologies on the performance of deep learning (DL) model for differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC).
METHOD


Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019 were assigned to training or internal test dataset, and external test dataset was acquired from The Cancer Genome Atlas-Kidney Renal Clear Cell Carcinoma (TCGA-KIRC) database. The effects of different methodologies on the performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL), were compared using repeated measures analysis of variance (ANOVA) and receiver operating characteristic (ROC) curve analysis. The performance of DL-model was evaluated through accuracy and ROC analyses with internal and external tests.
RESULTS


In this retrospective study, patients (n = 390) from one hospital were randomly assigned to training (n = 370) or internal test dataset (n = 20), and the other 20 patients from TCGA-KIRC database were assigned to external test dataset. IC, the attention level, MC, and TL had major effects on the performance of the DL-model. The DL-model based on the cropping of an image less than three times the tumor diameter, without attention, a simple model and the application of TL achieved the best performance in internal (ACC = 73.7 ± 11.6%, AUC = 0.82 ± 0.11) and external (ACC = 77.9 ± 6.2%, AUC = 0.81 ± 0.04) tests.
CONCLUSIONS


CT-based DL model can be conveniently applied for grading ccRCC with simple IC in routine clinical practice.",2020,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","['Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019', 'differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC', 'patients (n\u202f=\u202f390) from one hospital were randomly assigned to training (n\u202f=\u202f370) or internal test dataset (n\u202f=\u202f20), and the other 20 patients from TCGA-KIRC database']",['CT-based deep learning model'],"['performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0004170', 'cui_str': 'Bone structure of atlas'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4760635', 'cui_str': 'Transfer Learning'}]",,0.0253668,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Wansheng', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Enming', 'Initials': 'E', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China. Electronic address: cem2008@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109079']
1710,32526688,Examining the effect of a brief psychoeducation intervention based on self-regulation model on sexual satisfaction for women with breast cancer: A randomized controlled trial.,"PURPOSE


The main goal of this study was to investigate whether the Self-Regulation Model could improve sexual satisfaction for women diagnosed with breast cancer.
METHODS


Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran. Participants were randomly assigned to either an intervention group (n = 40) or a control group (n = 40). All participants were administered a demographic questionnaire and an Index of Sexual Satisfaction (ISS) pre-intervention, immediately post-intervention, and 1, 2, and 3 months following the intervention. The control group completed the assessments along the same time line as the intervention group. Women in the experimental group were provided three sessions of a psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies to improve their overall sexual satisfaction with sexual intercourse. Each intervention took between 60 and 90 min to administer.
RESULTS


The experimental and control group participants were well balanced in terms of demographic characteristics and sexual satisfaction scores before the intervention. The intervention group showed a positive increasing trend in the sexual satisfaction scores over time while the control group participants had a negative trend (p < 0.05). There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
CONCLUSION


Providing a psychoeducational based intervention provided an increase of sexual satisfaction during intercourse for women diagnosed with breast cancer. The psychoeducation based intervention provided an opportunity for participants to dispel common myths regarding their disease and obtain new strategies and skills to improve their sexual satisfaction from intercourse with their partners.",2019,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
","['women diagnosed with breast cancer', 'Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran', 'women with breast cancer']","['psychoeducational based intervention', 'Self-Regulation Model', 'psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies', 'psychoeducation intervention based on self-regulation model']","['demographic characteristics and sexual satisfaction scores', 'sexual satisfaction scores', 'sexual satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0482538,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Frouzan', 'Initials': 'F', 'LastName': 'Olfati', 'Affiliation': 'Metabolic Diseases Research Center, School of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: folfati@qums.ac.ir.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Oveisi', 'Affiliation': 'Metabolic Disease Research Center, School of Medicine, Qazvin University of Medical Science, Qazvin, Iran. Electronic address: soveysi@qums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: nbahrami@qums.ac.ir.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Astrologo', 'Affiliation': 'Interpersonal Relationships & Development Laboratory, Centre for Research in Human Development, Department of Psychology, Concordia University, Montréal, QC, Canada. Electronic address: lisa.astrologo@live.ca.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, Singapore. Electronic address: yiong_huak_chan@nuhs.edu.sg.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101673']
1711,32538182,Vitamin D levels in IBD: a randomised trial of weight-based versus fixed dose vitamin D supplementation.,"Objectives:  Body weight is one of the factors affecting blood levels of 25-hydroxyvitamin D (25OHD). The aim of this study was to establish whether a vitamin D (vitD) weight-based dosing is more appropriate to a fixed daily dose in patients with inflammatory bowel disease (IBD). Materials/methods:  This was an open label randomised trial. Patients with IBD were assigned to receive oral cholecalciferol at a dose of 28 IU/kg (IU/kg) or 2000 IU per day (IU/day) for 12 weeks during winter months. 25OHD plasma levels and other biochemical parameters were measured at baseline and after supplementation period. The primary outcome measure was 25OHD level after a follow-up period. Results:  A total of 173 patients were analysed. The mean BMI was 25.5 ± 5.1 and initial mean 25OHD level was 62.7 ± 25.5 nmol/l. A similar increase (9.7 ± 26.9 vs 9.8 ± 26.7 nmol/l) in 25OHD levels occurred both in IU/kg and IU/day group. The proportion of subjects with normal and sub-normal levels following the substitution was comparable irrespective of body weight. The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001). A sustained 25OHD level of 75 nmol/l corresponds with a calculated daily vitD dose of 2034 IU. Conclusions:  Weight-based dosing of vitamin D is not superior to a fixed dose in order to maintain stable 25OHD levels in IBD patients. Cholecalciferol dose of 2,000 IU/day is safe and sufficient during winter period.",2020,The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001).,"['IBD', 'A total of 173 patients were analysed', 'IBD patients', 'patients with inflammatory bowel disease (IBD', 'Patients with IBD']","['weight-based versus fixed dose vitamin D supplementation', 'Cholecalciferol', 'vitamin D (vitD) weight-based dosing', 'vitamin D', 'oral cholecalciferol']","['change in 25OHD level', '25OHD levels', '25OHD plasma levels', 'baseline 25OHD level', 'blood levels of 25-hydroxyvitamin D (25OHD', 'mean BMI', 'initial mean 25OHD level', '25OHD level', 'Vitamin D levels']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",173.0,0.398191,The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001).,"[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kojecky', 'Affiliation': 'Faculty of Medicine, Masaryk University Brno, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Matous', 'Affiliation': '2nd Department of Internal Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Kianicka', 'Affiliation': '2nd Department of Internal Medicine/Department of Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Dite', 'Affiliation': 'Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Zdena', 'Initials': 'Z', 'LastName': 'Zadorova', 'Affiliation': '2nd Department of Internal Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kubovy', 'Affiliation': 'Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hlostova', 'Affiliation': 'Institute of Health Information and Statistics of the Czech Republic, Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Uher', 'Affiliation': 'Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1774921']
1712,32540584,The effect of injection volume on long-term outcomes of US-guided subacromial bursa injections.,"PURPOSE


Limited data exist on the efficacy of high- compared to low-volume US-guided corticosteroid injections (CI) in the subacromial-subdeltoid (SA-SD) bursa. Our purpose was to compare the short- and long-term efficacy of low- and high-volume injections, by using a capacity reference of SA-SD bursa volume, as assessed on cadaveric specimens.
METHOD


Within two years, 136 patients (63 males, 73 females; mean age: 46.11 ± 10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included. Patients were randomly assigned to low-volume (1 mL triamcinolone acetonide/40 mg) or high-volume (1 mL triamcinolone acetonide/40 mg, 9 mL anaesthetic agents) groups (67 and 69 patients, respectively). Visual Analogue Scores (VAS) were recorded at baseline, 30 min, 3 weeks, 3 months, 6 months and 1 year post-treatment. Predictors of complete recovery (VAS ≤ 2) at 1 year were analysed with multivariate Cox regression analysis. SA-SD bursa cadaveric dissection in 10 specimens was performed for volume assessment.
RESULTS


Injection volume was the only predictor of complete pain resolution at 1 year. High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001). Mean VAS scores at baseline and subsequent time-points were 6, 2.6, 2.2, 2, 1.6 and 1 for the high-volume and 7.8, 7.3, 4.7, 3.2, 2.5 and 1.8 for the low-volume group, respectively (P < .001, at all time-points). Cadaveric measurements showed a minimum SA-SD bursa volume of approximately 6.9 mL.
CONCLUSIONS


High-compared to low-volume US-guided CI are superior for achieving early pain recovery.",2020,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","['136 patients (63 males, 73 females; mean age: 46.11\u202f±\u202f10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included']","['US-guided subacromial bursa injections', 'low-volume US-guided corticosteroid injections (CI', 'low- and high-volume injections', 'triamcinolone acetonide/40\u202fmg) or high-volume (1\u202fmL triamcinolone acetonide/40\u202fmg, 9\u202fmL anaesthetic agents']","['minimum SA-SD bursa volume', 'complete pain resolution', 'chances of early pain recovery', 'Visual Analogue Scores (VAS', 'Mean VAS scores']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}]","[{'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.107082,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","[{'ForeName': 'Michail E', 'Initials': 'ME', 'LastName': 'Klontzas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Advanced Hybrid Imaging Systems, Institute of Computer Science, Foundation for Research and Technology (FORTH), 100 N. Plastira str., Voutes, 70013, Heraklion, Crete, Greece.'}, {'ForeName': 'Evangelia E', 'Initials': 'EE', 'LastName': 'Vassalou', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, General Hospital of Sitia, Xserokamares, 72300, Sitia, Lasithi, Crete, Greece. Electronic address: vassalou.e@hotmail.com.'}, {'ForeName': 'Aristeidis H', 'Initials': 'AH', 'LastName': 'Zibis', 'Affiliation': 'University of Thessaly, Faculty of Medicine, Department of Anatomy Mezourlo Viopolis, 41222, Larissa, Greece.'}, {'ForeName': 'Apostolos H', 'Initials': 'AH', 'LastName': 'Karantanas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, Medical School, University of Crete, Voutes, 71110, Heraklion, Greece.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109113']
1713,32512314,Women's unmet needs in early labour: Qualitative analysis of free-text survey responses in the M@NGO trial of caseload midwifery.,"OBJECTIVE


to analyse women's experiences of early labour care in caseload midwifery in Australia.
DESIGN


this study sits within a multi-site randomised controlled trial of caseload midwifery versus standard care. Participant surveys were conducted at 6-weeks and 6-months after birth. Free-text responses about experiences of care were subject to critical thematic analysis in NVivo 11 software.
SETTING


two urban Australian hospitals in different states.
PARTICIPANTS


women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial.
INTERVENTIONS


participants were randomised to caseload midwifery or standard care for antenatal, labour and birth and postpartum care.
MEASUREMENTS AND FINDINGS


The 6-week survey response rate was 58% (n = 1,019). The survey included five open questions about women's experiences of pregnancy, labour and birth, and postnatal care. Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories. The category of early labour contained data from 84 individual participants (caseload care n = 44; standard care n = 40). Descriptive themes were: (1) needing permission; (2) doing the 'wrong' thing; and (3) being dismissed. Analytic themes were: (1) Seeking: women wanting to be ""close to those who know what's going on""; and (2) Shielding: midwives defending resources and normal birth.
KEY CONCLUSIONS


Regardless of model of care, early labour care was primarily described in negative terms. This could be attributed to reporting bias, because women who were neutral about early labour care may not comment. Nevertheless, the findings demonstrate a gap in knowledge about early labour care in caseload midwifery models.
IMPLICATIONS FOR PRACTICE


Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.",2020,"IMPLICATIONS FOR PRACTICE


Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","['two urban Australian hospitals in different states', 'Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories', '84 individual participants (caseload care n\xa0=\xa044; standard care n\xa0=\xa040', ""Women's unmet needs in early labour"", ""women's experiences of early labour care in caseload midwifery in Australia"", ""women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial""]","['caseload midwifery versus standard care', 'caseload midwifery or standard care for antenatal, labour and birth and postpartum care']","['pregnancy, labour and birth, and postnatal care']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]",,0.0808094,"IMPLICATIONS FOR PRACTICE


Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","[{'ForeName': 'Jyai', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; School of Nursing and Midwifery, Griffith University, Meadowbrook, Queensland, Australia. Electronic address: jyai.allen@griffith.edu.au.'}, {'ForeName': 'Bec', 'Initials': 'B', 'LastName': 'Jenkinson', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia. Electronic address: bec.jenkinson@mater.uq.edu.au.'}, {'ForeName': 'Sally K', 'Initials': 'SK', 'LastName': 'Tracy', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia. Electronic address: sally.tracy@sydney.edu.au.""}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Hartz', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia; College of Nursing and Midwifery, Charles Darwin University, Sydney Campus, New South Wales, Australia. Electronic address: donna.hartz@cdu.edu.au.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': ""Department of Paediatrics and Child health Westmead Children's Clinical School, The University of Sydney, Westmead, New South Wales, Australia; Westmead Neonatal Intensive Care Unit, Westmead Hospital, Western Sydney Local Health District, New South Wales, Australia. Electronic address: mark.tracy@sydney.edu.au.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kildea', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; Molly Wardaguga Research Centre, College of Nursing and Midwifery, Charles Darwin University, Queensland, Australia. Electronic address: sue.kildea@cdu.edu.au.'}]",Midwifery,['10.1016/j.midw.2020.102751']
1714,32512353,A Randomized Controlled Trial of Transcultural Validation of Group-Based Psychosocial Intervention for Patients with Bipolar Disorder.,"Adjunctive psychosocial interventions are part of the preferred method to treat bipolar disorder (BD). This study aimed to conduct a randomized control and protocol-guided trial, in order to evaluate the feasibility and effectiveness of adjunctive group-based treatments for Chinese outpatients with BD. A single-blind trial in which 68 outpatients with BD were randomly assigned to either treatment as usual (TAU) or to an experimental group with 12 additional weekly sessions and 3 monthly booster sessions. Participants were assessed at baseline for mood condition, suicidal ideation, medication adherence, and quality of life (QoL), with follow-up assessments every 3 months over a 1-year period. The overall retention rate of this study was 89.7%. The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed. The results of this study support the transcultural validity and efficacy of group-based psychosocial intervention as anadjunct to TAU among Chinese outpatients with BD to promote improvements during the course of the illness including achieving euthymia, reducing depressive symptoms, and improving QoL.",2020,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","['68 outpatients with BD', 'Patients with Bipolar Disorder', 'Chinese outpatients with BD']","['Adjunctive psychosocial interventions', 'psychosocial intervention', 'Group-Based Psychosocial Intervention']","['mood condition, suicidal ideation, medication adherence, and quality of life (QoL', 'medication adherence, reduction in manic symptoms, or suicidal ideation', 'feasibility and effectiveness', 'depression symptoms', 'transcultural validity and efficacy', 'depressive symptoms, and improving QoL', 'overall retention rate']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",68.0,0.0479467,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","[{'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Health and Welfare Policy, National Yang-Ming University.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Yang', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Taiwan Adventist Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-I', 'Initials': 'SI', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Audiology and Speech Language Pathology, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hung', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'I-Chieh', 'Initials': 'IC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'School of Medicine, Deakin University, Victoria, Australia.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan. Electronic address: maryliuyip@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113139']
1715,32515748,Exploring the Effectiveness of an Integrated Physical Activity and Psychosocial Program Targeting At-Risk Adolescent Girls: Protocol for the Girls United and on the Move (GUM) Intervention Study.,"BACKGROUND


Adolescents are highly susceptible to negative self-perceptions, likely due to their social cues and environment. The presence of these negative self-perceptions has been shown to adversely impact levels of physical activity (PA). Although PA has the ability to foster improved self-perceptions, the rates of PA among adolescents continue to descend, with girls appearing to be most susceptible to these declines. At-risk adolescent girls, who may experience a number of negative preceding lifestyle conditions, may be exceptionally vulnerable to declines in PA. There are a high number of adolescent girls from low-income and abusive households in British Columbia, Canada, thus indicating a need for a program to relay the importance of PA and healthy lifestyle behaviors.
OBJECTIVE


This paper aims to describe the protocol of the Girls United and on the Move (GUM) pragmatic intervention, an integrated PA and psychosocial program aimed at improving self-compassion, social connectedness, and overall self-perceptions among at-risk adolescent girls.
METHODS


Using a quasi-experimental mixed methods approach, the GUM intervention was conducted in 5 schools in British Columbia, Canada. Adolescent girls aged 11 to 15 years who were identified as at risk were included in the study. The 9-week intervention, co-delivered by a PA/health promotion-trained researcher and a registered social worker, involved a PA component and a psychosocial component with evidence-based topics addressing the concerns of the adolescent girls. The following outcomes were evaluated: PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment. Program acceptability and satisfaction was also examined. Outcome measures were assessed at baseline (week 1), week 6, and postintervention (week 9), and interview data concerning program acceptability and satisfaction were collected at postintervention from a subsample of participants.
RESULTS


A total of 101 participants were invited to participate in the GUM intervention. Reporting of the results is projected for the fall of 2020.
CONCLUSIONS


It is anticipated that the GUM intervention will enhance PA while also improving self-compassion, social connectedness, and overall self-perceptions among at-risk adolescent girls. The findings of this research will contribute to the literature concerning PA and various psychosocial factors that impact the physical and mental health of at-risk adolescent girls.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03567200; https://clinicaltrials.gov/ct2/show/NCT03567200.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15302.",2020,"The following outcomes were evaluated: PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment.","['risk adolescent girls', 'At-risk adolescent girls', 'Adolescent girls aged 11 to 15 years who were identified as at risk were included in the study', '101 participants were invited to participate in the GUM intervention', '5 schools in British Columbia, Canada']","['Integrated Physical Activity and Psychosocial Program', '9-week intervention, co-delivered by a PA/health promotion-trained researcher and a registered social worker, involved a PA component and a psychosocial component with evidence-based topics addressing the concerns of the adolescent girls', 'GUM intervention']","['Program acceptability and satisfaction', 'interview data concerning program acceptability and satisfaction', 'PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}]",101.0,0.0129728,"The following outcomes were evaluated: PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment.","[{'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Caperchione', 'Affiliation': 'School of Sport, Exercise and Rehabilitation, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hargreaves', 'Affiliation': 'School of Health and Exercise Science, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': 'Okanagan School of Education, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Kent C', 'Initials': 'KC', 'LastName': 'Kowalski', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Leah J', 'Initials': 'LJ', 'LastName': 'Ferguson', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK, Canada.'}]",JMIR research protocols,['10.2196/15302']
1716,32523793,"Probiotic treatment induced change of inflammation related metabolites in IBS-D patients/double-blind, randomized, placebo-controlled trial.","There have been many studies suggesting that probiotics are effective in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). However, its mechanism of action as well as prediction of response is still to be elucidated. In the present study, to find out metabolomic characteristics of probiotic effect in IBS-D, we compared IBS symptom changes and metabolomic characteristics in the subjects' urine samples between multi-strain probiotics (one strain of  Lactobacillus  sp. and four strains of  Bifidobacterium  sp.) group (n = 32) and placebo group (n = 31). After 8 weeks' administration (3 times/day), dissatisfaction in bowel habits and stool frequencies were significantly improved. Also, probiotics group had significantly changed seven metabolites including palmitic acid methyl ester (PAME) and 4,6-dihydroxyquinoline, 4-(2-aminophenyl)-2,4-dioxobutanoic acid (DOBA). According to IBS-SSS and IBS-QoL questionnaires, IBS-SSS responders showed higher PAME levels and IBS-QoL responders showed lower DOBA levels. This suggests potential role of these metabolites as a biomarker to predict probiotics effect in IBS-D patients.",2020,"After 8 weeks' administration (3 times/day), dissatisfaction in bowel habits and stool frequencies were significantly improved.",['patients with diarrhea-predominant irritable bowel syndrome (IBS-D'],"['Probiotic treatment', 'placebo']","['palmitic acid methyl ester (PAME) and 4,6-dihydroxyquinoline, 4-(2-aminophenyl)-2,4-dioxobutanoic acid (DOBA', 'dissatisfaction in bowel habits and stool frequencies', 'inflammation related metabolites', 'DOBA levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0066275', 'cui_str': 'methyl palmitate'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.131296,"After 8 weeks' administration (3 times/day), dissatisfaction in bowel habits and stool frequencies were significantly improved.","[{'ForeName': 'Jinjoo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Kumsun', 'Initials': 'K', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Joo Sung', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Hyun Chae', 'Initials': 'HC', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Bumsik', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, Yeonsung University, Anyang, Gyeonggi 14011 Republic of Korea.'}, {'ForeName': 'Myeong Soo', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Bifodo Co., Hongcheon, Gangwon 25117 Republic of Korea.'}, {'ForeName': 'Geun Eog', 'Initials': 'GE', 'LastName': 'Ji', 'Affiliation': 'Bifodo Co., Hongcheon, Gangwon 25117 Republic of Korea.'}, {'ForeName': 'Joo-Youn', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Kyoung Sup', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Department of Gastroenterology, Mediplex Sejong Hospital, 20, Gyeyangmunhwa-ro, Gyeyang-gu, Incheon, 21080 Republic of Korea.'}]",Food science and biotechnology,['10.1007/s10068-019-00717-2']
1717,30388029,Changes in Sleep Problems Across Attention-Deficit/Hyperactivity Disorder Treatment: Findings from the Multimodal Treatment of Attention-Deficit/Hyperactivity Disorder Study.,"Objective:  Stimulant medication and behavior therapy are efficacious for youth with attention-deficit/hyperactivity disorder (ADHD). However, research suggests that stimulants may start and/or worsen sleep problems for youth. Further, the impact of behavior therapy for ADHD on sleep is unknown. This study examined the frequency of sleep problems and effects of stimulant medication, behavior therapy, and their combination on sleep problems in youth with ADHD. This study also explored the influence of dimensional baseline ratings of ADHD symptom subtype and psychiatric comorbidity on sleep outcomes.  Methods:  Participants were 576 children (aged 7-9 years) with ADHD-Combined type from the Multimodal Treatment of ADHD study that compared methylphenidate, behavior therapy, and their combination to community care. Before treatment, parents completed the Child Behavior Checklist used to derive a total sleep problems score. Parents also completed ratings of oppositionality and ADHD symptom severity, whereas youth completed ratings of depression and anxiety. These ratings were readministered after treatment.  Results:  General linear mixed-effects models were used to assess change in total sleep problems across treatment. The combined group exhibited a statistically significant reduction in total sleep problems ( z  = -5.81,  p  < 0.001). Reductions in total sleep problems in methylphenidate (z = -3.11,  p  = 0.05), behavior therapy ( z  = -2.99,  p  = 0.08), or community care ( z  = -1.59,  p  > 0.99) did not reach statistical significance. Change in psychiatric symptoms did not significantly moderate change in total sleep problems by treatment assignment. Greater baseline oppositional defiant disorder severity predicted less reduction in total sleep problems, χ 2 (1) = 3.86,  p  < 0.05.  Conclusions:  Findings suggest that combination of methylphenidate and behavior therapy is efficacious for reducing parent-reported sleep problems in young children with ADHD-Combined type relative to community care. However, potential ameliorative effects of monotherapy treatments (i.e., methylphenidate, behavior therapy) should be examined. Future replication is needed to confirm findings.",2018,"Reductions in total sleep problems in methylphenidate (z = -3.11,  p  = 0.05), behavior therapy ( z  = -2.99,  p  = 0.08), or community care ( z  = -1.59,  p  > 0.99) did not reach statistical significance.","['youth with ADHD', 'young children with ADHD-Combined type relative to community care', 'Participants were 576 children (aged 7-9 years) with ADHD-Combined type from the Multimodal Treatment of ADHD study that compared', 'youth with attention-deficit/hyperactivity disorder (ADHD']","['methylphenidate, behavior therapy, and their combination to community care', 'Stimulant medication and behavior therapy', 'methylphenidate', 'methylphenidate and behavior therapy', 'stimulant medication, behavior therapy, and their combination']","['behavior therapy', 'total sleep problems score', 'ratings of oppositionality and ADHD symptom severity', 'total sleep problems']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",576.0,0.0514823,"Reductions in total sleep problems in methylphenidate (z = -3.11,  p  = 0.05), behavior therapy ( z  = -2.99,  p  = 0.08), or community care ( z  = -1.59,  p  > 0.99) did not reach statistical significance.","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sturm', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'McMakin', 'Affiliation': 'Department of Psychology, Florida International University, Miami, Florida.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Patricia Z', 'Initials': 'PZ', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Fallon B', 'Initials': 'FB', 'LastName': 'Smalberg', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Colwell', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0038']
1718,32530717,The impact of a yoga-based physical therapy group for individuals with traumatic brain injury: results from a pilot study.,"OBJECTIVE


To compare the impacts of yoga-based physical therapy versus a seated rest within the context of standard rehabilitation practice on sleep, heart rate variability (HRV), anxiety, and fatigue during acute traumatic brain injury (TBI) rehabilitation.
METHODS


Eleven individuals participated in this crossover study involving the following interventions in a randomized order: group yoga-based physical therapy (YPT), conventional physical therapy (CPT), and group seated rest in a relaxing environment (SR). HRV and self-reported anxiety and fatigue were measured immediately before and after each group, and sleep after each condition and at baseline. Data was analyzed using generalized linear mixed models with repeated measures.
RESULTS


The interaction between time and treatment was statistically significant ( p  = .0203). For the SR treatment, wake after sleep onset (WASO) rate was reduced from 14.99 to 10.60 (IRR = 0.71;  p  = .006). Time and treatment were not found to be statistically significantly associated with any of the secondary outcomes.
CONCLUSION


Yoga-based physical therapy is feasible and safe in the inpatient rehabilitation setting following TBI. Sleep quality improved following the addition of a one-hour seated rest in a relaxing environment to a standard rehabilitation daily schedule, suggesting that structured rest time may be beneficial to sleep hygiene during inpatient rehabilitation following TBI. ClinicalTrials.Gov Registration Number: NCT03701594.",2020,"Time and treatment were not found to be statistically significantly associated with any of the secondary outcomes.
","['Eleven individuals participated', 'individuals with traumatic brain injury']","['Yoga-based physical therapy', 'yoga-based physical therapy (YPT), conventional physical therapy (CPT), and group seated rest in a relaxing environment (SR', 'yoga-based physical therapy']","['sleep, heart rate variability (HRV), anxiety, and fatigue', 'sleep onset (WASO) rate', 'Sleep quality', 'HRV and self-reported anxiety and fatigue']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",11.0,0.0600584,"Time and treatment were not found to be statistically significantly associated with any of the secondary outcomes.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Krese', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ingraham', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': ""O'Brien"", 'Affiliation': 'Max Näder Center for Rehabilitation Technologies and Outcomes Research, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Chaithanya K', 'Initials': 'CK', 'LastName': 'Mummidisetty', 'Affiliation': 'Max Näder Center for Rehabilitation Technologies and Outcomes Research, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McNulty', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Srdanovic', 'Affiliation': 'Biostatistics Collaboration Center, Northwestern University Feinberg School of Medicine , Chicago, Illinois, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Biostatistics Collaboration Center, Northwestern University Feinberg School of Medicine , Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ripley', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}]",Brain injury,['10.1080/02699052.2020.1776394']
1719,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND


External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
OBJECTIVE


To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
METHODS


Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
RESULTS


Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
CONCLUSIONS


ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005']
1720,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND


Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates.
OBJECTIVE


We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation.
METHODS


We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms.
RESULTS


Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013).
CONCLUSIONS


Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007']
1721,32534369,Hydroxychloroquine/ chloroquine as a treatment choice or prophylaxis for Covid-19 at the primary care level in developing countries: A Primum non Nocere dilemma.,"The Food and Drug Administration (FDA) warned against the use of Hydroxychloroquine or chloroquine for Covid-19 outside of a hospital or a clinical trial setting due to the risk of QT interval prolongation, ventricular tachycardia and the increased risk of these complications when combined with some antibiotics such as azithromycin. Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients. Despite these warnings, in several developing countries the official guidelines for treatment of Covid-19 patients at the primary care level recommend Hydroxychloroquine and azithromycin, among other treatments, as the first-choice for mild symptomatic Covid-19 patients, asymptomatic contacts or for prophylaxis. In our opinion there is a primum non nocere dilemma during this Covid-19 pandemic. In order to solve this bioethical problem, we strongly recommend that a randomized controlled trial in a primary care setting be carried out as a matter of urgency in these areas of the world.",2020,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.",['COVID-19 hospitalized patients'],"['azithromycin', 'Hydroxychloroquine/ chloroquine', 'Hydroxychloroquine or chloroquine', 'Hydroxychloroquine and azithromycin']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0510268,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.","[{'ForeName': 'Marco T', 'Initials': 'MT', 'LastName': 'Medina', 'Affiliation': 'Faculty of Medical Sciences, National Autonomous University of Honduras, WFN Regional Director for Latin America, Tegucigalpa, Honduras. Electronic address: marcotmedina@yahoo.com.'}, {'ForeName': 'Sir Salvador', 'Initials': 'SS', 'LastName': 'Moncada', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Manchester, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116972']
1722,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1723,32535138,The effects of foam roll on perceptual and performance recovery during a futsal tournament.,"The present study investigated the efficacy of recovery by foam rolling (FR) on performance, psychological, and physiological parameters of futsal players in a simulated futsal tournament. In this randomized controlled trial design, four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches). Sixteen youth futsal players from two teams (age: 19.1 ± 1.3 years old) were randomly distributed into two groups: (i) passive recovery (PR); and (ii) FR recovery. The FR recovery protocol consisted of five repetitions of 40 s separated by 20 s of rest on calf, quadriceps, hamstrings, and gluteus muscles 5 min after each match. The other group rested passively during the same period. The Yo-Yo intermittent recovery level 2, repeated sprint ability, vertical jump, and PRO agility tests were assessed pre- and post-tournament. Also, Hooper index (HI) and blood lactate concentrations were measured throughout matchdays. Data were analyzed by a repeated measure ANOVA and ANCOVA. Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05). Although FR recovery was slightly beneficial when compared to PR attenuated decrements in aerobic (-1.6%vs-9.7%) and anaerobic performance (-4.5%vs-1.3%), vertical jump (-1.6%vs-3.0%), and change of direction (-2.1%vs-4.3%), these effects were not statistically significant (p>0.05). The finding showed using FR during compact competitions expedites physical performance recovery, increases blood lactate clearance and leads to regenerate psychological characteristics. Therefore, along with other desirable recovery strategies, the use of FR could be recommended in short-term compacted futsal tournaments.",2020,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"['Sixteen youth futsal players from two teams (age: 19.1±1.3 years old', ""four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches"", 'futsal players in a simulated futsal tournament']","['passive recovery (PR); and (ii) FR recovery', 'foam rolling (FR', 'foam roll']","['Hooper index (HI) and blood lactate concentrations', 'perceptual and performance recovery', 'repeated sprint ability, vertical jump, and PRO agility tests', 'lactate removal', 'blood lactate clearance', 'anaerobic performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0276004,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347, Viana do Castelo, Portugal; Instituto de Telecomunicações, Delegação da Covilhã, Lisboa 1049-001, Portugal. Electronic address: filipeclemente@esdl.ipvc.pt.""}]",Physiology & behavior,['10.1016/j.physbeh.2020.112981']
1724,32535591,Identifying Predictors of the Visceral Fat Index in the Obese and Overweight Population to Manage Obesity: A Randomized Intervention Study.,"INTRODUCTION


Nowadays, obesity is one of the main causes of death and disability. In recent years, it has been shown that the excess and distribution of body fat increases morbidity, with excess visceral fat being the most important factor that triggers pathologies. Thus, estimation of visceral fat makes it possible to identify patients with a higher cardiovascular risk, aiding the management of obesity. The main objective of the study was to identify predictors of the visceral fat index through a lifestyle intervention and to observe the effect of the intervention on dietary habits and functional capacity.
METHODS


A randomized intervention, parallel-group study was made. This study included 97 obese and overweight people (control group, n = 48; experimental group, n = 49) with a low socioeconomic status in an 8-month lifestyle intervention. Anthropometric, fitness and nutritional tests were assessed.
RESULTS


It was found that being female, eating the recommended daily portions of fruit, gaining strength in the legs and gaining flexibility are factors predictive of a lower visceral fat index. Age over 45 years and eating the recommended weekly portions of cereals and meats, fat and processed meats increases the visceral fat index after a lifestyle intervention. There were changes in the visceral fat index and in the different physical condition variables, but not in eating habits.
CONCLUSION


A multicomponent lifestyle intervention reduces the visceral fat index; age over 45 and consuming cereals and meat increases the visceral fat index.",2020,A multicomponent lifestyle intervention reduces the visceral fat index; age over 45 and consuming cereals and meat increases the visceral fat index.,"['97 obese and overweight people (control group, n = 48; experimental group, n = 49) with a low socioeconomic status in an 8-month lifestyle intervention', 'Obese and Overweight Population to Manage Obesity']",['multicomponent lifestyle intervention'],"['Anthropometric, fitness and nutritional tests', 'dietary habits and functional capacity', 'visceral fat index', 'Visceral Fat Index']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",97.0,0.0156355,A multicomponent lifestyle intervention reduces the visceral fat index; age over 45 and consuming cereals and meat increases the visceral fat index.,"[{'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'López-Hernández', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez-Ros', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, Valencia, Spain, pilar.perez@ucv.es.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fargueta', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Elvira', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'López-Soler', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pablos', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}]",Obesity facts,['10.1159/000507960']
1725,32517123,Lactobacillus rhamnosus GG  (ATCC 53103) for the Management of Infantile Colic: A Randomized Controlled Trial.,"BACKGROUND


The aim of this study was to investigate the efficacy of  Lactobacillus rhamnosus  ATCC 53103 together with the maternal diet avoidance of cow's milk in treating infantile colic.
METHODS


Forty-five colicky breastfed infants were consecutively randomized to receive  L. rhamnosus  for 28 days at a dosage of 5 × 10 9  cfu per day or placebo. Faecal samples were collected from each subject before starting supplementation and at the end of the study period and were immediately analysed. Faecal calprotectin was detected via a quantitative assay. The total bacterial load and selected bacterial species were evaluated using real-time TaqMan PCR.
RESULTS


After supplementation for 28 days with  Lactobacillus rhamnosus  ATCC 53103, median full-force daily crying was reduced (104 versus 242 min,  p  < 0.001) and the values of faecal calprotectin decreased significantly ( p =  0.026). Furthermore, the probiotic increased the abundance of  Lactobacillus  ( p  = 0.048) and total bacteria ( p  = 0.040); all these effects were not observed in the placebo group.
CONCLUSION


Infants treated with  Lactobacillus rhamnosus ATCC 53103  for 28 days, in association with the elimination of cow's milk from the maternal diet, presented some interesting features related to the effect of this probiotic treatment: reductions in crying time and faecal calprotectin, with increased total bacteria and  Lactobacillus.  To validate these results, a double-blind, placebo-controlled trial on a larger cohort is required.",2020,"Furthermore, the probiotic increased the abundance of  Lactobacillus  ( p  = 0.048) and total bacteria ( p  = 0.040); all these effects were not observed in the placebo group.
","['Forty-five colicky breastfed infants', 'Infantile Colic']","['Lactobacillus rhamnosus', 'Lactobacillus rhamnosus GG  (ATCC 53103', 'ATCC', 'Lactobacillus rhamnosus ATCC', 'placebo']","['total bacterial load and selected bacterial species', 'total bacteria', 'abundance of  Lactobacillus', 'values of faecal calprotectin', 'crying time and faecal calprotectin', 'total bacteria and  Lactobacillus', 'median full-force daily crying', 'Faecal calprotectin']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0857334', 'cui_str': 'Colicky sensation quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0266836', 'cui_str': 'Infantile colic'}]","[{'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",53103.0,0.178844,"Furthermore, the probiotic increased the abundance of  Lactobacillus  ( p  = 0.048) and total bacteria ( p  = 0.040); all these effects were not observed in the placebo group.
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savino', 'Affiliation': 'Department of Pediatrics, S.S.D. Subintensive Neonatal Care, Children Hospital ""Regina Margherita"", A.U.O. Città della Salute e della Scienza di Torino, 10126 Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Montanari', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Galliano', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Daprà', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Bergallo', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}]",Nutrients,['10.3390/nu12061693']
1726,32517188,Effect of the Fat Eaten at Breakfast on Lipid Metabolism: A Crossover Trial in Women with Cardiovascular Risk.,"Recent studies point out that not only the daily intake of energy and nutrients but the time of day when they are ingested notably regulates lipid metabolism and cardiovascular risk (CVR). Therefore, the aim of the study was to assess if the type of fat ingested at breakfast can modify lipid metabolism in women with CVR. A randomized, crossover clinical trial was performed. Sixty volunteers were randomly assigned to a (A) polyunsaturated fatty acid (PUFA)-rich breakfast, (B) saturated fatty acid (SFA)-rich breakfast, or (C) monounsaturated fatty acid (MUFA)-rich breakfast. Plasma lipoprotein and apolipoprotein subfractions were determined. Our data showed that the PUFA-rich breakfast decreased lipoprotein (a) (Lp(a)), very low-density lipoproteins (VLDL), and intermediate-density lipoproteins (IDL), and increased high-density lipoproteins (HDL). A similar trend was observed for the MUFA-rich breakfast, whereas the SFA-rich breakfast, although it decreased VLDL, also increased IDL and reduced HDL. The PUFA-rich breakfast also decreased β-lipoproteins and apolipoprotein-B. In summary, varying the type of fat eaten at breakfast is enough to significantly modify the lipid metabolism of women with CVR, which can be of great relevance to establish new therapeutic strategies for the treatment of these subjects.",2020,The PUFA-rich breakfast also decreased β-lipoproteins and apolipoprotein-B.,"['women with CVR', 'Sixty volunteers', 'Women with Cardiovascular Risk']","['Fat Eaten at Breakfast', 'polyunsaturated fatty acid (PUFA)-rich breakfast, (B) saturated fatty acid (SFA)-rich breakfast, or (C) monounsaturated fatty acid (MUFA)-rich breakfast']","['Lipid Metabolism', 'lipid metabolism and cardiovascular risk (CVR', 'lipid metabolism', 'Plasma lipoprotein and apolipoprotein subfractions', 'IDL and reduced HDL', 'PUFA-rich breakfast decreased lipoprotein (a) (Lp(a)), very low-density lipoproteins (VLDL), and intermediate-density lipoproteins (IDL), and increased high-density lipoproteins (HDL', 'β-lipoproteins and apolipoprotein-B']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}]","[{'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0583325', 'cui_str': 'Plasma lipoprotein measurement'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0065063', 'cui_str': 'Intermediate density lipoprotein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}]",60.0,0.0268842,The PUFA-rich breakfast also decreased β-lipoproteins and apolipoprotein-B.,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Delgado-Alarcón', 'Affiliation': 'Health Science PhD program, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Hernández Morante', 'Affiliation': 'Eating Disorder Research Unit., Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Francisco V', 'Initials': 'FV', 'LastName': 'Aviles', 'Affiliation': 'Service of Biochemistry, Hospital Universitario Virgen de la Arrixaca, 30120 Murcia, Spain.'}, {'ForeName': 'María D', 'Initials': 'MD', 'LastName': 'Albaladejo-Otón', 'Affiliation': 'Service of Biochemistry, Hospital Universitario Santa Lucia of Cartagena, 30202 Murcia, Spain.'}, {'ForeName': 'Juana M', 'Initials': 'JM', 'LastName': 'Morillas-Ruíz', 'Affiliation': 'Food Technology and Nutrition Department, Catholic University of Murcia, 30107 Murcia, Spain.'}]",Nutrients,['10.3390/nu12061695']
1727,32216457,Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients.,"OBJECTIVES


The authors have previously tried to develop a model for the testing of novel drug candidates for migraine, using the headache and migraine provoking agent cilostazol. Previous studies have used sumatriptan tablets as the validating drug, but they were not sufficiently effective. In this study we test the effect of subcutaneous sumatriptan on cilostazol induced headache in patients with migraine without aura.
METHOD


Thirty patients with migraine without aura received 200 mg cilostazol on two different study days. The induced headache was treated with subcutaneous sumatriptan in a randomized, double-blind cross-over design. The patients filled out a self-reported headache questionnaire until 12 h after cilostazol.
RESULTS


All 30 patients experienced headache (range 3-10) on both study days and the headache fulfilled the criteria for a migraine-like attack in 73% on the sumatriptan day and in 77% on the placebo day. Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003). The difference between headache intensity on the sumatriptan day and the placebo day was significant at both 2 h ( p  = 0.01) and 4 h ( p  = 0.0007) after treatment.
CONCLUSION


Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. The cilostazol model may be useful as a tool to test the potential of new anti-migraine drugs. Trial registration:  The study is registered on clinicaltrials.gov (NCT03422796).",2020,Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003).,"['Thirty patients with migraine without aura received 200 mg cilostazol on two different study days', 'All 30 patients experienced headache (range 3-10) on both study days and the headache fulfilled the criteria for a migraine-like attack in 73% on the sumatriptan day and in 77% on the', 'patients with migraine without aura', 'migraine patients']","['Subcutaneous sumatriptan', 'subcutaneous sumatriptan', 'Sumatriptan', 'placebo']","['headache questionnaire', 'cilostazol induced headache', 'headache intensity', 'headache score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0650812,Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003).,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Helene Rønde', 'Initials': 'HR', 'LastName': 'Bjerg', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420915166']
1728,32527152,Feasible Policy Evaluation by Design: A Randomized Synthetic Stepped-Wedge Trial of Mandated Disclosure in King County.,"Evidence-based policy is limited by the perception that randomized controlled trials (RCTs) are expensive and infeasible. We argue that carefully tailored research design can overcome these challenges and enable more widespread randomized evaluations of policy implementation. We demonstrate how a stepped-wedge (randomized rollout) design that adapts synthetic control methods overcame substantial practical, administrative, political, and statistical constraints to evaluating King County's new food safety rating system. The core RCT component of the evaluation came at little financial cost to the government, allowed the entire county to be treated, and resulted in no functional implementation delay. The case of restaurant sanitation grading has played a critical role in the scholarship on information disclosure, and our study provides the first evidence from a randomized trial of the causal effects of grading on health outcomes. We find that the grading system had no appreciable effects on foodborne illness, hospitalization, or food handling practices but that the system may have marginally increased public engagement by encouraging higher reporting.",2020,"We find that the grading system had no appreciable effects on foodborne illness, hospitalization, or food handling practices but that the system may have marginally increased public engagement by encouraging higher reporting.",['King County'],[],"['foodborne illness, hospitalization, or food handling practices', 'public engagement']","[{'cui': 'C0454792', 'cui_str': 'Offaly'}]",[],"[{'cui': 'C0016479', 'cui_str': 'Food poisoning'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0016469', 'cui_str': 'Food Handling'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.102428,"We find that the grading system had no appreciable effects on foodborne illness, hospitalization, or food handling practices but that the system may have marginally increased public engagement by encouraging higher reporting.","[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Handan-Nader', 'Affiliation': 'Department of Political Science, Stanford University, CA, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Ho', 'Affiliation': 'Regulation, Evaluation and Governance Lab, Stanford University, CA, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Elias', 'Affiliation': 'Food Protection Program, Environmental Health Services, Public Health-Seattle & King County, Seattle, WA, USA.'}]",Evaluation review,['10.1177/0193841X20930852']
1729,32527389,Effects of Age and Acute Moderate Alcohol Consumption on Electrophysiological Indices of Attention.,"OBJECTIVE


Despite increased attention to risks and benefits associated with moderate drinking lifestyles among aging adults, relatively few empirical studies focus on acute alcohol effects in older drinkers. Using electroencephalographic indices of early attention modulation (P1 and N1) and later stimulus processing (P3), we investigated whether acute alcohol consumption at socially relevant doses differentially influences neurocognitive performance in older, relative to younger, moderate drinkers.
METHOD


Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers were randomly assigned to receive one of three alcohol doses (placebo, .04 g/dl, or .065 g/dl target breath alcohol concentrations). Repeated-measures analysis of variance examined the effects of age, alcohol dose concentration, and their potential interaction on P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task.
RESULTS


Age-specific effects on P1 amplitudes varied by instruction set, with alcohol-associated decreases in amplitude among older drinkers in response to task-relevant stimuli and increases to irrelevant stimuli, F(2, 141) = 2.70, p = .07, η p 2  = .04. In contrast, N1 analyses demonstrated alcohol-related latency reductions among older, relative to younger, adults, F(2, 83) = 3.42, p = .04. Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) = 5.73, p < .01, η p 2  = .08.
CONCLUSIONS


Our results underscore the impact of acute moderate alcohol consumption on attentional functioning, highlighting age-dependent sensitivity in electrophysiological indices of early attentional processing. Given the import of attentional functioning to quality of life and increases in drinking among a rapidly expanding aging population, these findings have broad public health relevance.",2020,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","['older drinkers', 'older, relative to younger, moderate drinkers', 'Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers']","['early attention modulation (P1 and N1) and later stimulus processing (P3', 'alcohol doses (placebo, .04']",['P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337677', 'cui_str': 'Moderate drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",87.0,0.0715192,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","[{'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'University of Florida Center for Addiction Research & Education, Gainesville, Florida.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}]",Journal of studies on alcohol and drugs,[]
1730,32539204,The efficacy of macro-focused ultrasound in the treatment of upper facial laxity: A pilot study.,"BACKGROUND


Recently, macro-focused ultrasound (MFU) has become a popular noninvasive esthetic treatment for facial laxity. However, there are no studies done that evaluated the use of MFU with a 2.0 mm transducer for upper facial lifting.
AIMS


To evaluate the efficacy and safety of MFU with a 2.0 mm transducer in the treatment of upper facial laxity in Thai patients.
METHODS


This was a prospective, evaluator-blinded pilot study with 34 Thai patients diagnosed with mild to moderate facial laxity. Patients were treated with a single session of MFU with 2.0 mm transducer at the forehead, lateral and just below the eye area. Primary outcome was the clinical improvement of upper facial laxity graded by 2 blinded dermatologists at baseline, 1-week, 1-, 3-, and 6-month follow-up. Objective measurements including eyebrow height, upper facial volume, and textural irregularities were evaluated. Patients' self-assessment scores and adverse effects were also recorded.
RESULTS


Out of 34 patients, 27 (79.4%) attended all follow-ups. Clinical improvement of upper facial laxity was observed as early as 1-week follow-up. Eyebrow height elevation was significantly increased at every follow-up (P = .000) with an average of 1.22 mm at 6-month follow-up. Wrinkles improved significantly at 1-week and 6-month follow-up (P = .002 and P = .010, respectively). Skin roughness showed significant improvement at 6-month follow-up (P = .004). Majority of the patients (53.6%) reported marked improvement at 3-month follow-up. No serious adverse event was noted.
CONCLUSION


Macro-focused ultrasound is a safe and effective treatment for upper facial laxity and skin textural irregularities in patients with mild to moderate degree of laxity.",2020,"Wrinkles improved significantly at 1-week and 6-month follow-up (p=0.002 and p=0.010, respectively).","['upper facial laxity in Thai patients', '34 Thai patients diagnosed with mild to moderate facial laxity', 'upper facial laxity', 'Out of 34 patients, 27 (79.4%) attended all follow-ups', 'patients with mild to moderate degree of laxity']","['macro-focused ultrasound', 'macro-focused ultrasound (MFU', 'MFU']","['clinical improvement of upper facial laxity graded by 2 blinded dermatologists', 'upper facial laxity', ""Patients' self-assessment scores and adverse effects"", 'Wrinkles', 'efficacy and safety', 'Skin roughness', 'Eyebrow height elevation', 'eyebrow height, upper facial volume and textural irregularities']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",34.0,0.027383,"Wrinkles improved significantly at 1-week and 6-month follow-up (p=0.002 and p=0.010, respectively).","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ya-Nin', 'Initials': 'YN', 'LastName': 'Nokdhes', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ploypailin', 'Initials': 'P', 'LastName': 'Tantrapornpong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13550']
1731,32540134,Event-related desynchronization of alpha and beta band neural oscillations predicts speech and limb motor timing deficits in normal aging.,"Normal aging is associated with decline of motor timing mechanisms implicated in planning and execution of movement. Evidence from previous studies has highlighted the relationship between neural oscillatory activities and motor timing processing in neurotypical younger adults; however, it remains unclear how normal aging affects the underlying neural mechanisms of movement in older populations. In the present study, we recorded EEG activities in two groups of younger and older adults while they performed randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli. Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli. This behavioral effect was accompanied by significant desynchronization of alpha (7-12 Hz) and beta (13-25 Hz) band neural oscillatory activities in older compared with younger adults, primarily during the preparatory pre-motor phase of responses for speech production and limb movement. In addition, we found that faster motor reaction times in younger adults were significantly correlated with weaker desynchronization of pre-motor alpha and beta band neural activities irrespective of stimulus timing and response modality. However, the pre-motor components of alpha and beta activities were timing-specific in older adults and were more strongly desynchronized in response to temporally predictable sensory stimuli. These findings highlight the role of alpha and beta band neural oscillations in motor timing processing mechanisms and reflect their functional deficits during the planning phase of speech production and limb movement in normal aging.",2020,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","['Normal Aging', 'neurotypical younger adults', 'two groups of younger and older adults', 'older adults']",['randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli'],['faster motor reaction times'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0320888,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States; Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States. Electronic address: r-behroozmand@sc.edu.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112763']
1732,32540838,COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study.
OBJECTIVE


In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study.
METHODS


The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8"" step, and a large-print 8"" × 11"" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months.
RESULTS


The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021.
CONCLUSIONS


This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18415.",2020,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"['325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments', 'participants with MS who would otherwise have discontinued the study', '759 people enrolled and baseline tested in the study (92.5% of our baseline testing completion target: 820', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'adults with MS']","['synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized', 'comprehensive exercise/rehabilitation services', 'alternative medicine (CAM) intervention', 'teleassessment package (laptop computer, blood pressure cuff, hand dynamometer, mini- disc cone, measuring tape, an 8"" step, and a large print 8""x11"" paper with ruler metrics and wall-safe tape) and virtual meeting platform for synchronous interactive training between therapist and participant']","['resting blood pressure and heart rate, the Hand-Grip Strength Test; Five Times Sit to Stand test; Timed Up & Go test; and Berg Balance Scale']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C3881002', 'cui_str': 'Mini disc'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",759.0,0.0382581,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"[{'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Division of Pediatric Rehabilitation Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Chia-Ying', 'Initials': 'CY', 'LastName': 'Chiu', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pounds', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.""}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Tracy', 'Affiliation': 'Tanner Foundation, Birmingham, AL, United States.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Young', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Riser', 'Affiliation': 'Tanner Foundation, Birmingham, AL, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rimmer', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.""}]",JMIR research protocols,['10.2196/18415']
1733,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND


Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol.
MATERIALS AND METHODS


We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model.
RESULTS


The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving.
CONCLUSIONS


Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028']
1734,32535342,Food intake is associated with verbal interactions between nursing home staff and residents with dementia: A secondary analysis of videotaped observations.,"BACKGROUND


Nursing home residents with dementia commonly experience low food intake, leading to negative functional and nutritional consequences. While the importance of staff-resident (dyadic) interactions during mealtime is acknowledged, little research has examined the role of dyadic verbal interactions on food intake.
OBJECTIVES


This study aimed to examine the relationship between food intake and dyadic verbal interactions.
METHODS


This study was a secondary analysis of 110 videotaped observations of mealtime care interactions among 25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes. Staff positive utterances and resident positive and negative utterances (independent variables) and food intake (dependent variable) were coded from the videotaped observations using the Cue Utilization and Engagement in Dementia video coding scheme. A linear mixed model was fit to the data. The two-way interaction effects of food type and video duration with each independent variable as well as two-way interaction effects among the independent variables were tested. Covariates included in the model were the number of years staff worked as a caregiver, and resident age, gender, and eating function.
RESULTS


The model included three significant interaction effects involving verbal variables: the interaction effect of staff positive utterances with resident positive utterances (p=.030), the interaction effect of staff positive utterances with food type (p=.027), and the interaction effect of resident negative utterances with video duration (p=0.002). Increased number of intakes of liquid food per minute was associated with increased number of staff positive utterances per minute when residents did not make positive utterances. Decreased number of intakes of solid food per minute was associated with increased number of staff positive utterances per minute, especially when residents made between 0 and 3 positive utterances per minute. As the duration of the videos increased, the number of intakes per minute increased for residents who made one or more negative utterances and decreased for residents who made no negative utterances in the videos. The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
CONCLUSION


Intake was associated with dyadic verbal interactions, and such relationship was complex in that it was moderated by food type and video duration. Findings support the significant role of dyadic verbal interactions on intake, and inform the development of effective, tailored mealtime care interventions to promote intake.",2020,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","['25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes', 'nursing home staff and residents with dementia']",[],"['number of intakes per minute', 'dyadic verbal interactions', 'Staff positive utterances and resident positive and negative utterances (independent variables) and food intake', 'number of staff positive utterances']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",110.0,0.0676015,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA. Electronic address: wen-liu-1@uiowa.edu.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Perkhounkova', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'The University of Kansas, School of Nursing, Kansas City, KS, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Batchelor', 'Affiliation': 'George Washington University, School of Nursing, Washington, D.C., USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103654']
1735,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION


PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers.
METHODS


A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study.
RESULTS


Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups.
CONCLUSIONS


Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02629289; NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x']
1736,31613134,Effects of parenting adults with disabilities on later-life health: The role of intergenerational ambivalence.,"According to family systems theory, strains from parenting an adult with disabilities may spill over to parents' relationships with their other children and disrupt family dynamics and their well-being in later-life. This study examined whether parental ambivalence toward their nondisabled children is greater in families of adults with disabilities (developmental disabilities [DD] or serious mental illnesses [SMI]) than families without any adult children with disabilities. The study also investigated whether ambivalence mediates the associations between having an adult child with DD or SMI and parents' health. Data were from the 2011 Wisconsin Longitudinal Study in which aging parents (M age  = 71; n = 6,084) were asked about their relationship with each of their adult children. Multilevel regression models and multilevel structural equation models were estimated to analyze the data. Our findings showed that parents of an adult with SMI felt greater ambivalence toward their nondisabled adult children than comparison group parents of adult children without disabilities, whereas no significant differences were found between parents of an adult child with DD and comparison group parents. Parental ambivalence toward their nondisabled adult children played a significant indirect role in the negative association between having a child with SMI and parental physical and mental health. The findings have implications for clinical practice with aging families of adults with disabilities and suggest the need for additional research to better understand intergenerational parent-adult child dynamics in these families. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Parental ambivalence toward their nondisabled adult children played a significant indirect role in the negative association between having a child with SMI and parental physical and mental health.,"['2011 Wisconsin Longitudinal Study in which aging parents (M age  = 71; n = 6,084', 'parenting adults with disabilities on later-life health', 'adult children with disabilities', ""adult child with DD or SMI and parents' health"", 'adults with disabilities', 'families of adults with disabilities (developmental disabilities [DD']",[],[],"[{'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0524331', 'cui_str': 'Elderly parents'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}]",[],[],6084.0,0.027497,Parental ambivalence toward their nondisabled adult children played a significant indirect role in the negative association between having a child with SMI and parental physical and mental health.,"[{'ForeName': 'Eun Ha', 'Initials': 'EH', 'LastName': 'Namkung', 'Affiliation': 'Lurie Institute for Disability Policy.'}, {'ForeName': 'Jan S', 'Initials': 'JS', 'LastName': 'Greenberg', 'Affiliation': 'School of Social Work, University of Wisconsin- Madison.'}, {'ForeName': 'Marsha R', 'Initials': 'MR', 'LastName': 'Mailick', 'Affiliation': 'Waisman Center, University of Wisconsin- Madison.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Floyd', 'Affiliation': 'Department of Psychology, University of Hawaii at Manoa.'}]",Psychology and aging,['10.1037/pag0000413']
1737,32527511,Initial testing of a computer-based simulation training module to support clinicians' acquisition of CBT skills for substance use disorder treatment.,"Cognitive behavioral therapy (CBT) is one of the most common and effective treatments for substance use disorders (SUD); however, effective delivery of CBT depends on a wide variety of nuanced skills that require practice to master. We created a computer-based simulation training system to support the development of necessary skills for student trainees to be able to apply CBT effectively for clients with SUDs. CBT: Introducing Cognitive Behavioral Therapy is an interactive, role-play simulation that provides opportunities for clinician trainees to hone their skills through repeated practice and real-time feedback before application in a clinical setting. This is the first study that tests whether such a simulation improves trainee skills for the treatment of clients with SUDs. Graduate students (N = 65; social work, clinical psychology) completed standardized patient (SP) interviews, were randomized to the simulation training program or manual comparison condition (Project MATCH manual), and completed SP interviews three months post-baseline. Using general linear models, results indicated a significant time x group effect, with students assigned to the simulation training program showing greater improvement in ""extensiveness"" and ""skillfulness"" ratings across three skill categories: general agenda setting (p = .03), explaining CBT concepts (p = .007), and understanding of CBT concepts (p = .001). However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range  = .013-.024). No changes in extensiveness or skillfulness of motivational interviewing (MI) style were observed. This pilot test of CBT: Introducing Cognitive Behavioral Therapy offers support for use of this novel technology as a potential approach to scale up CBT training for students, and perhaps clinicians, counseling people with SUDs.",2020,"However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range  = .013-.024).","['students, and perhaps clinicians, counseling people with SUDs', 'clients with SUDs', 'Graduate students (N\xa0=\xa065; social work, clinical psychology) completed standardized patient (SP) interviews']","['Cognitive behavioral therapy (CBT', 'CBT', 'simulation training program or manual comparison condition (Project MATCH manual), and completed SP interviews three months post-baseline']","['extensiveness or skillfulness of motivational interviewing (MI) style', 'extensiveness"" and ""skillfulness"" ratings', 'trainee skills']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0033912', 'cui_str': 'Clinical Psychology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0439795', 'cui_str': 'Extensiveness'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",65.0,0.013923,"However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range  = .013-.024).","[{'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Binghamton University, College of Community and Public Affairs, PO Box 6000, Binghamton, NY 13902, United States of America. Electronic address: nmastrol@binghamton.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Humm', 'Affiliation': 'SIMmersion, LLC, 8681 Robert Fulton Drive #E, Columbia, MD 21046, United States of America.'}, {'ForeName': 'Callon M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'Binghamton University, College of Community and Public Affairs, PO Box 6000, Binghamton, NY 13902, United States of America.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, Temple Medical Center, 40 Temple St., Suite 6C, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hoadley', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, School of Public Health, Box G S-121-5, Providence, RI 02912, United States of America.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Magill', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, School of Public Health, Box G S-121-5, Providence, RI 02912, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108014']
1738,32530765,Prospective Evaluation of Radiation Dose Escalation in Patients With High-Risk Neuroblastoma and Gross Residual Disease After Surgery: A Report From the Children's Oncology Group ANBL0532 Study.,"PURPOSE


A primary objective of the Children's Oncology Group (COG) ANBL0532 phase III study was to assess the effect of increasing local dose of radiation to a residual primary tumor on the cumulative incidence of local progression (CILP) in patients with high-risk neuroblastoma.
PATIENTS AND METHODS


Newly diagnosed patients with high-risk neuroblastoma were randomly assigned or assigned to receive single or tandem autologous stem-cell transplantation (SCT) after induction chemotherapy. Local control consisted of surgical resection during induction chemotherapy and radiotherapy after last SCT. Patients received 21.6 Gy to the preoperative primary tumor volume. For patients with incomplete surgical resection, an additional boost of 14.4 Gy was delivered to the gross residual tumor, for a total dose of 36 Gy. CILP (primary end point) and event-free (EFS) and overall survival (OS; secondary end points) were compared with the COG A3973 historical cohort, in which all patients received single SCT and 21.6 Gy without a boost.
RESULTS


For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P  = .0590), 47.0% ± 3.5% ( P  = .0090), and 57.4% ± 3.5% ( P  = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively. Five-year CILP, EFS, and OS rates for patients in A3973 with incomplete resection and radiotherapy (n = 47) were 10.6% ± 4.6%, 48.9% ± 10.1%, and 56.9% ± 10.0%, respectively. In comparison, 5-year CILP, EFS, and OS rates for patients in ANBL0532 who were randomly assigned or assigned to single SCT and received boost radiotherapy (n = 74) were 16.3% ± 4.3% ( P  = .4126), 50.9% ± 7.0% ( P  = .5084), and 68.1% ± 6.7% ( P  = .2835), respectively.
CONCLUSION


Boost radiotherapy to gross residual tumor present at the end of induction did not significantly improve 5-year CILP. These results highlight the need for new strategies to decrease the risk of locoregional failure.",2020,"For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P  = .0590), 47.0% ± 3.5% ( P  = .0090), and 57.4% ± 3.5% ( P  = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively.","['Patients With High-Risk Neuroblastoma and Gross Residual Disease', 'Newly diagnosed patients with high-risk neuroblastoma', 'patients with high-risk neuroblastoma']","['radiotherapy', 'ANBL0532 receiving radiotherapy', 'surgical resection during induction chemotherapy and radiotherapy', 'boost radiotherapy', 'Radiation Dose Escalation', 'single or tandem autologous stem-cell transplantation (SCT) after induction chemotherapy', 'Boost radiotherapy']","['EFS, and OS rates', 'risk of locoregional failure', 'CILP (primary end point) and event-free (EFS) and overall survival', 'local progression (CILP', '5-year CILP, EFS, and OS rates', '5-year CILP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",47.0,0.0978828,"For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P  = .0590), 47.0% ± 3.5% ( P  = .0090), and 57.4% ± 3.5% ( P  = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively.","[{'ForeName': 'Kevin X', 'Initials': 'KX', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham & Women's Hospital, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Fan F', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, CA.""}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'DuBois', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Stephan D', 'Initials': 'SD', 'LastName': 'Voss', 'Affiliation': ""Department of Radiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Geetika', 'Initials': 'G', 'LastName': 'Khanna', 'Affiliation': ""Department of Radiology, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Doski', 'Affiliation': ""Department of Surgery/Pediatric Surgery Division, University of Texas Health Science Center, San Rosa Children's Hospital, San Antonio, TX.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Geiger', 'Affiliation': ""Section of Pediatric Surgery, Department of Surgery, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kreissman', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Diller', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA.""}, {'ForeName': 'Daphne A', 'Initials': 'DA', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham & Women's Hospital, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03316']
1739,32532098,"Improvement in Healthy Meal Index, Lunch Quality, and Diversity Scores Following an Integrated Nutritional Intervention in a Communal Dining Room: The NEKST Study.","The objective of the NEKST (Nutrition Environmental Kibbutzim Study), a nonrandomized interventional study, was to evaluate the effect of an integrated intervention program on participants' lunch quality and diversity in two communal dining rooms (intervention  n  = 58 vs. control  n  = 54). The intervention included recipe modification, environmental changes, and an education program. The outcomes included simple healthy meal index (SHMI), lunch quality (LQS), and diversity scores (LDS) calculated based on photographs of lunch trays. A nutrition questionnaire assessed the changes in fruit and vegetable intake at baseline and 3 months following the intervention. The mean SHMI, LQS, and LDS increased in the intervention group (0.51,  p  < 0.001; 0.27,  p  = 0.045; 0.95,  p  < 0.001, respectively) but not in the control group ( p  = 0.865;  p  = 0.339;  p  = 0.354, respectively). Multivariable linear models demonstrate an increase in the SHMI (β = 0.26, 95% CI [0.12-0.76],  p  = 0.015), LQS (β = 0.23, 95% CI [0.06-0.83],  p  = 0.024), and LDS (β = 0.34, 95% CI [0.41-1.39],  p  < 0.001) of the participants in the intervention group. More participants in the intervention group raised their daily fruit intake compared with the control. We conclude that this integrated intervention program was effective in improving lunch healthy meal index, quality, and diversity in a communal dining room, with a modest halo effect of the intervention throughout the day.",2020,"The mean SHMI, LQS, and LDS increased in the intervention group (0.51,  p  < 0.001; 0.27,  p  = 0.045; 0.95,  p  < 0.001, respectively) but not in the control group (","[""participants' lunch quality and diversity in two communal dining rooms (intervention  n  = 58 vs. control  n  = 54""]",['integrated intervention program'],"['simple healthy meal index (SHMI), lunch quality (LQS), and diversity scores (LDS) calculated based on photographs of lunch trays', 'mean SHMI, LQS, and LDS', 'lunch healthy meal index, quality, and diversity', 'daily fruit intake', 'fruit and vegetable intake', 'LQS', 'Healthy Meal Index, Lunch Quality, and Diversity Scores']","[{'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0557648', 'cui_str': 'Dining room'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",,0.0399714,"The mean SHMI, LQS, and LDS increased in the intervention group (0.51,  p  < 0.001; 0.27,  p  = 0.045; 0.95,  p  < 0.001, respectively) but not in the control group (","[{'ForeName': 'Ofira', 'Initials': 'O', 'LastName': 'Katz-Shufan', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Tzahit', 'Initials': 'T', 'LastName': 'Simon-Tuval', 'Affiliation': 'Department of Health Systems Management, Guilford Glazer Faculty of Business and Management and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Sabag', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Danit', 'Initials': 'D', 'LastName': 'R Shahar', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}]",Nutrients,['10.3390/nu12061741']
1740,32538495,Caffeine improves various aspects of athletic performance in adolescents independent of their 163 C > A CYP1A2 genotypes.,"PURPOSE


The purpose of this study was to investigate whether variations in 163 C > A CYP1A2 genotypes (rs 762 551) (AA, AC, and CC) modify the ergogenic effects of caffeine (CAF) on strength, power, muscular endurance, agility, and endurance in adolescent athletes.
METHODS


One hundred adolescents (age = 15 ± 2 years) were recruited. Participants ingested CAF (6 mg.kg -1  ) or placebo (PLA, 300 mg of cellulose) 1 hour before performing a sequence of physical tests: handgrip strength, vertical jumps, agility test, sit-ups, push-ups, and the Yo-Yo intermittent recovery test level 1 (Yo-Yo IR1).
RESULTS


Compared to PLA, CAF enhanced (P < .05) sit-up (CAF = 37 ± 9; PLA = 35 ± 8 repetitions) and push-up repetitions (CAF = 26 ± 11; PLA = 24 ± 11 repetitions), and increased distance covered in Yo-Yo IR1 test (CAF = 1010.4 ± 378.9; PLA = 903.2 ± 325.7 m). There was no influence of CAF on handgrip strength (CAF = 35.1 ± 8.9; PLA = 33.7 ± 8.7 kgf), countermovement jump height (CAF = 49.3 ± 12.6; PLA = 47.9 ± 13.8 cm), spike jump height (CAF = 54.2 ± 13.6; PLA = 52.9 ± 14.5 cm), and time in agility test (CAF = 15.8 ± 1.1; PLA = 15.9 ± 1.3 s, P > .05). When present, the ergogenic effect of CAF was not dependent of genotype.
CONCLUSION


CAF improves muscular endurance and aerobic performance in adolescent athletes, regardless of their 163 C > A CYP1A2 genotype.",2020,"Compared to PLA, CAF enhanced (p < 0.05) sit-up (CAF = 37 ± 9; PLA = 35 ± 8 repetitions) and push-up repetitions (CAF = 26 ± 11; PLA = 24 ± 11 repetitions), and increased distance covered in Yo-Yo IR1 test (CAF = 1010.4 ± 378.9; PLA = 903.2 ± 325.7 m).","['163 C', 'One hundred adolescents (age = 15 ± 2 years) were recruited', 'adolescent athletes, regardless of their 163 C', 'adolescents independent of their 163 C', 'adolescent athletes']","['placebo (PLA, 300 mg of cellulose) one hour before performing a sequence of physical tests: handgrip strength, vertical jumps, agility test, sit-ups, push-ups and the Yo-Yo intermittent recovery test level 1 (Yo-Yo IR1', 'Caffeine', 'CAF', 'caffeine (CAF']","['CAF on handgrip strength', 'countermovement jump height', 'strength, power, muscular endurance, agility and endurance', 'spike jump height', 'muscular endurance and aerobic performance', 'time in agility test', 'athletic performance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]",,0.023064,"Compared to PLA, CAF enhanced (p < 0.05) sit-up (CAF = 37 ± 9; PLA = 35 ± 8 repetitions) and push-up repetitions (CAF = 26 ± 11; PLA = 24 ± 11 repetitions), and increased distance covered in Yo-Yo IR1 test (CAF = 1010.4 ± 378.9; PLA = 903.2 ± 325.7 m).","[{'ForeName': 'Higor', 'Initials': 'H', 'LastName': 'Spineli', 'Affiliation': 'Postgraduate Program in Nutrition - PPGNUT, Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Maryssa P', 'Initials': 'MP', 'LastName': 'Pinto', 'Affiliation': 'Postgraduate Program in Nutrition - PPGNUT, Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Bruna P', 'Initials': 'BP', 'LastName': 'Dos Santos', 'Affiliation': 'Postgraduate Program in Health Sciences - PPGCS, Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Human Performance Research Group, Technological Federal University of Parana, Parana, Brazil.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research Group (GEDAE-USP), School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel L G', 'Initials': 'DLG', 'LastName': 'Gitaí', 'Affiliation': 'Postgraduate Program in Health Sciences - PPGCS, Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Gustavo G', 'Initials': 'GG', 'LastName': 'de Araujo', 'Affiliation': 'Postgraduate Program in Nutrition - PPGNUT, Federal University of Alagoas, Alagoas, Brazil.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13749']
1741,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy+cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE


Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy+cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed.
MATERIALS AND METHODS


Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40 mg/m 2  weekly) in combination with concurrent cetuximab (loading dose 400 mg/m 2 , then 250 mg/m 2  weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m 2  biweekly × 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed.
RESULTS


Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p ≤ 0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers.
CONCLUSIONS


There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011']
1742,32540922,Association of Long-term Change and Variability in Glycemia With Risk of Incident Heart Failure Among Patients With Type 2 Diabetes: A Secondary Analysis of the ACCORD Trial.,"OBJECTIVE


To evaluate the associations between long-term change and variability in glycemia with risk of heart failure (HF) among patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


Among participants with T2DM enrolled in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, variability in HbA 1c  was assessed from stabilization of HbA 1c  following enrollment (8 months) to 3 years of follow-up as follows: average successive variability (ASV) (average absolute difference between successive values), coefficient of variation (SD/mean), and SD. Participants with HF at baseline or within 3 years of enrollment were excluded. Adjusted Cox models were used to evaluate the association of percent change (from baseline to 3 years of follow-up) and variability in HbA 1c  over the first 3 years of enrollment and subsequent risk of HF.
RESULTS


The study included 8,576 patients. Over a median follow-up of 6.4 years from the end of variability measurements at year 3, 388 patients had an incident HF hospitalization. Substantial changes in HbA 1c  were significantly associated with higher risk of HF (hazard ratio [HR] for ≥10% decrease 1.32 [95% CI 1.08-1.75] and for ≥10% increase 1.55 [1.19-2.04]; reference <10% change in HbA 1c ). Greater long-term variability in HbA 1c  was significantly associated with higher risk of HF (HR per 1 SD of ASV 1.34 [95% CI 1.17-1.54]) independent of baseline risk factors and interval changes in cardiometabolic parameters. Consistent patterns of association were observed with use of alternative measures of glycemic variability.
CONCLUSIONS


Substantial long-term changes and variability in HbA 1c  were independently associated with risk of HF among patients with T2DM.",2020,Substantial changes in HbA 1c  were significantly associated with higher risk of HF (hazard ratio [HR] for ≥10% decrease 1.32,"['Participants with HF at baseline or within 3 years of enrollment were excluded', '2 Diabetes', '8,576 patients', 'Among participants with T2DM enrolled in the ACCORD trial', 'patients with type 2 diabetes mellitus (T2DM', 'Patients With Type', 'patients with T2DM']",[],"['Glycemia', 'average successive variability (ASV', 'cardiometabolic parameters']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",[],"[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004429', 'cui_str': 'Avian sarcoma virus'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",8576.0,0.0476585,Substantial changes in HbA 1c  were significantly associated with higher risk of HF (hazard ratio [HR] for ≥10% decrease 1.32,"[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Segar', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Kershaw V', 'Initials': 'KV', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Caughey', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina and North Carolina State University, Chapel Hill, NC.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, Division of Cardiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Grodin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX ambarish.pandey@utsouthwestern.edu.'}]",Diabetes care,['10.2337/dc19-2541']
1743,32541370,Can Treatment With Citicoline Eyedrops Reduce Progression in Glaucoma? The Results of a Randomized Placebo-controlled Clinical Trial.,"PRECIS


Citicoline eyedrops in patients with progressing glaucoma.
PURPOSE


This study aimed to test whether the additional therapy with citicoline eyedrops to intraocular pressure (IOP)-lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mm Hg or less.
DESIGN


This was a randomized, double-masked, placebo-controlled, multicenter 3-year study.
OUTCOMES


The outcomes studied were difference in the visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression and difference in retinal nerve fiber layer (RNFL) thickness change between the 2 study groups at 3 years.
METHODS


Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5 dB/y in the 2 years before enrollment despite IOP ≤18 mm Hg were randomized to receive citicoline eyedrops or placebo 3 times daily for 3 years. Patients were followed every 3 months and underwent a visual field examination with 24-2 and 10-2 strategies and RNFL assessment. Analysis of variance and linear models were used to test the differences between groups.
RESULTS


Eighty patients were randomized in the trial. The mean 3-year rates of progression were -1.03 (2.14) dB in the citicoline group and -1.92 (2.23) dB in the placebo group (P=0.07) for 24-2 MD and -0.41 (3.45) dB in the citicoline group and -2.22 (3.63) dB in the placebo group (P=0.02) for 10-2 MD. On average, patients receiving citicoline eyedrops lost 1.86 μm of RNFL in 3 years, versus 2.99 μm in the placebo group (P=0.02).
CONCLUSIONS


Additional treatment with citicoline eyedrops to IOP-lowering treatment might reduce disease progression in patients with progressing glaucoma despite IOP ≤18 mm Hg.",2020,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"['y in the 2 years before enrolment despite IOP ≤18▒mmHg', 'Eighty patients', 'patients with progressing glaucoma', 'Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5▒', 'patients with progressing glaucoma despite IOP ≤18▒mmHg', 'patients with worsening of damage and IOP 18 mmHg or less']","['Placebo', 'citicoline eyedrops or placebo', 'citicoline eyedrops', 'Citicoline Eyedrops', 'PRECIS\n\n\nCiticoline eyedrops', 'citicoline eyedrops to intraocular pressure (IOP) -lowering treatment', 'placebo']","['disease progression', 'visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression; difference in retinal nerve fiber layer (RNFL) thickness change']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.500531,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Iester', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tranchina', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ottobelli', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Coco', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Calcatelli', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ancona', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cirafici', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Manni', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001565']
1744,32534724,The Effectiveness of a Time Management Workshop on Job Stress of Nurses Working in Emergency Departments: An Experimental Study.,"INTRODUCTION


One of the main risk factors for poor health is a high level of job stress. Time management skills can greatly reduce job stress. The current study aimed to evaluate the effectiveness of a one-time management training workshop on job stress among nurses working in emergency departments.
METHODS


This randomized experimental study was carried out with 80 nurses working in emergency departments affiliated with a university of medical sciences. The intervention was an 8-hour workshop on time management. Pre- and posttest data were collected by demographic questionnaire and an occupational stress inventory before and 1 month after intervention. Data were analyzed using descriptive, chi-square, t test, Fisher exact, and analysis of covariance statistics.
RESULTS


The mean of job stress in the intervention group increased after the intervention (186.22, SD = 22.97) from baseline (182.52, SD = 34.39) compared with the mean of job stress in the control group (204.42, SD = 22.42) and (204.35, SD = 22.45). The control group had a significantly higher job stress score before the intervention (t = -3.37, P = 0.001). There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
DISCUSSION


The time management skills training program did not reduce the moderate-high levels of job stress of nurses in emergency departments. Addressing other sources of job stress, besides time management, is needed.",2020,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","['80 nurses working in emergency departments affiliated with a university of medical sciences', 'nurses working in emergency departments', 'Job Stress of Nurses Working in Emergency Departments']","['one-time management training workshop', 'Time Management Workshop']","['job stress score', 'job stress scores', 'job stress', 'mean of job stress', 'moderate-high levels of job stress']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]","[{'cui': 'C0556514', 'cui_str': 'Time management training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.0212648,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Karbakhsh Ravari', 'Affiliation': ''}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': ''}, {'ForeName': 'Monirsadat', 'Initials': 'M', 'LastName': 'Nematollahi', 'Affiliation': ''}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': ''}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.013']
1745,32543211,"Effects of Chiropractic Care on Strength, Balance, and Endurance in Active-Duty U.S. Military Personnel with Low Back Pain: A Randomized Controlled Trial.","Objectives:  To investigate whether chiropractic care influences strength, balance, and/or endurance in active-duty United States military personnel with low back pain (LBP).  Design:  This study employed a prospective randomized controlled trial using a pragmatic treatment approach. Participants were randomly allocated to 4 weeks of chiropractic care or to a wait-list control.  Interventions:  Chiropractic care consisted of spinal manipulation, education, advice, and reassurance.  Settings/Location:  Naval Air Technical Training Center branch clinic at the Naval Hospital Pensacola Florida.  Subjects:  One hundred ten active-duty military personnel 18-40 years of age with self-reported LBP.  Outcome measures:  Isometric pulling strength from a semisquat position was the primary outcome. Secondary outcomes were single-leg balance with eyes open and eyes closed, and trunk muscle endurance using the Biering-Sorensen test. Patient-reported outcomes such as pain severity and disability were also measured. Outcomes were measured at baseline and 4 weeks. Linear mixed-effects regression models over baseline and 4 weeks were used for analysis.  Results:  Participants had mean age of 30 years (18-40), 17% were female, 33% were non-white, and 86% reported chronic LBP. Mean maximum pulling strength in the chiropractic group increased by 5.08 kgs and decreased by 7.43 kgs in the wait-list group, with a statistically significant difference in mean change between groups ( p  = 0.003). Statistically significant differences in mean change between groups were also observed in trunk muscle endurance (13.9 sec,  p  = 0.002) and balance with eyes closed (0.47 sec,  p  = 0.01), but not in balance with eyes open (1.19 sec,  p  = 0.43). Differences in mean change between groups were statistically significant in favor of chiropractic for LBP-related disability, pain intensity and interference, and fear-avoidance behavior.  Conclusions:  Active-duty military personnel receiving chiropractic care exhibited improved strength and endurance, as well as reduced LBP intensity and disability, compared with a wait-list control.",2020,"Differences in mean change between groups were statistically significant in favor of chiropractic for LBP-related disability, pain intensity and interference, and fear-avoidance behavior.  ","['Subjects', 'One hundred ten active-duty military personnel 18-40 years of age with self-reported LBP', 'active-duty United States military personnel with low back pain (LBP', 'Participants had mean age of 30 years (18-40), 17% were female, 33% were non-white, and 86% reported chronic LBP', 'Active-Duty U.S. Military Personnel with Low Back Pain']","['chiropractic care or to a wait-list control', 'Chiropractic Care', 'Chiropractic care consisted of spinal manipulation, education, advice, and reassurance']","['LBP intensity and disability', 'Mean maximum pulling strength', 'pain severity and disability', 'LBP-related disability, pain intensity and interference, and fear-avoidance behavior', 'trunk muscle endurance', 'single-leg balance with eyes open and eyes closed, and trunk muscle endurance using the Biering-Sorensen test', 'Isometric pulling strength from a semisquat position', 'strength and endurance', 'Strength, Balance, and Endurance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",110.0,0.117342,"Differences in mean change between groups were statistically significant in favor of chiropractic for LBP-related disability, pain intensity and interference, and fear-avoidance behavior.  ","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vining', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Long', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Minkalis', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'M Ram', 'Initials': 'MR', 'LastName': 'Gudavalli', 'Affiliation': 'College of Chiropractic Medicine, Keiser University, West Palm Beach, FL, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'Mechanical Engineering Department, Northern Illinois University, DeKalb, IL, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Samueli Integrative Health Programs, H&S Ventures, Alexandria, VA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Coulter', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Goertz', 'Affiliation': 'Department of Orthopedic Surgery, Duke University School of Medicine, Durham, NC, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0107']
1746,32543212,Mindfulness and Modified Medical Yoga as Intervention in Older Women with Osteoporotic Vertebral Fracture.,"Background:  People with osteoporotic vertebral compression fractures (VCFs) have decreased health-related quality of life (HRQoL). Yoga and mindfulness are methods that can promote well-being.  Objective:  The aim of this article was to explore the effect of mindfulness and modified medical yoga on HRQoL, stress, sleep, and pain in people 60 years or older with a diagnosed osteoporotic VCF.  Design:  The School of Osteoporosis in Linköping (SOL) is a pilot study with randomized groups.  Materials and Methods:  The SOL-study was scheduled to once a week for 10 weeks. Ten people were randomized to a theory (T) group, and ten people were randomized to a theory and mindfulness/medical yoga (MMY) group. The educational sessions lasted 60 min and were similar for the groups, but they took place at different facilities. An experienced physiotherapist supervised the MMY sessions for 60 min. Sleep quality and present stress experience were measured on a symmetric Likert scale. The numeric rating scale was used for pain, and EQ-5D, RAND-36, and Qualeffo-41 were used for HRQoL. The patient enablement instrument (PEI) was used to reflect how the participants coped with their illness.  Results:  Eight women in the MMY-group and seven women in the T-group completed the SOL study interventions. The adherence to the intervention program was 89% in the MMY-group and 87% in the T-group. There was no adverse consequence of the MMY training. After the 10-week intervention period, sleep quality ( p  = 0.018) and present stress ( p  = 0.043), but not perceived pain were improved in the MMY-group. The social function (SF) domain was improved in the MMY-group that was measured by both RAND-36 ( p  = 0.028) and Qualeffo-41 ( p  = 0.012). There was a trend toward a better PEI-score in the MMY-group compared with the T-group postintervention ( p  = 0.089).  Conclusion:  This article suggests that mindfulness and modified medical yoga supervised by a skilled physiotherapist may be a feasible way to improve SF, sleep, and stress in older women with osteoporotic VCFs.",2020,The social function (SF) domain was improved in the MMY-group that was measured by both RAND-36 ( p  = 0.028) and Qualeffo-41 ( p  = 0.012).,"['people 60 years or older with a diagnosed osteoporotic VCF', 'People with osteoporotic vertebral compression fractures (VCFs', 'Older Women with Osteoporotic Vertebral Fracture', 'older women with osteoporotic VCFs']","['mindfulness and modified medical yoga', 'Mindfulness and Modified Medical Yoga', 'theory and mindfulness/medical yoga (MMY']","['PEI-score', 'social function (SF) domain', 'Sleep quality and present stress experience', 'HRQoL, stress, sleep, and pain', 'pain', 'sleep quality', 'numeric rating scale was used for pain, and EQ-5D, RAND-36, and Qualeffo-41']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012236', 'cui_str': ""DiGeorge's syndrome""}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0056079', 'cui_str': 'COF protocol'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",10.0,0.0451376,The social function (SF) domain was improved in the MMY-group that was measured by both RAND-36 ( p  = 0.028) and Qualeffo-41 ( p  = 0.012).,"[{'ForeName': 'Ann-Charlotte', 'Initials': 'AC', 'LastName': 'Grahn Kronhed', 'Affiliation': 'Rehab Väst, Local Health Care Services in the West of Östergötland, Östergötland, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enthoven', 'Affiliation': 'Division of Physiotherapy, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Spångeus', 'Affiliation': 'Department of Acute Internal Medicine and Geriatrics and Linköping University, Linköping, Sweden.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Willerton', 'Affiliation': 'Rehab Väst, Local Health Care Services in the West of Östergötland, Östergötland, Sweden.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0450']
1747,32535263,Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial.,"BACKGROUND


Postoperative cognitive dysfunction (POCD) is a complication of central nervous system in patients after surgery. Edaravone as a brain-protective agent may have protective effect on postoperative cognitive function. The study was designed to explore the effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery and potential mechanism.
PATIENTS AND METHODS


Patients undergoing hip joint replacement surgery were randomly allocated into 2 groups: the edaravone group (group E) and the control group (group C). Group E received intravenous edaravone at a dose of 0.5 mg/kg after induction of anesthesia, while group C received normal saline. The cognitive function was evaluated with the Mini-Mental State Examination (MMSE) 1day before surgery,3 days and the 7 days after surgery. Patients' plasma samples were collected to detect the levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA) before the induction of anesthesia, at the end of surgery and on postoperative day 3.
RESULTS


The MMSE scores in group E were higher than those of group C 3 days after surgery (25.98 ± 1.99 vs 24.86 ± 1.86, p = 0.003). There were remarkable rises (p < 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p < 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03 ± 2.46U/ml vs. 13.65 ± 2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01 ± 2.37 nmol/ml vs. 11.34 ± 3.18 nmol/ml, p = 0.0001).
CONCLUSION


The results indicated that preoperative intervention with edaravone may improve the postoperative cognitive function in elderly patients undergoing hip joint replacement surgery.",2020,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","['eldely patients undergoing hip joint replacement surgery and potential mechanism', 'Patients undergoing hip joint replacement surgery', 'patients after surgery', 'elderly patients undergoing hip joint replacement surgery']","['intravenous edaravone', 'normal saline', 'edaravone', 'Edaravone']","['MDA level', 'MMSE scores', 'cognitive function', 'SOD concentration', 'levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA', 'postoperative cognitive function', 'plasma IL-6, S100βand MMP-9 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.097904,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China. Electronic address: sun_long2@163.com.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China.'}, {'ForeName': 'Yang-Liang', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: nange1984@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.092']
1748,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND


Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate.
OBJECTIVE


This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game.
PARTICIPANTS AND SETTING


The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia.
METHOD


All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34).
RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not.
CONCLUSIONS


This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569']
1749,32535341,Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study.,"BACKGROUND


People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain due to lie supine for at least 4 hours to avoid bleeding and hematoma. Body positioning is an effective and safe method for decreasing back pain in people with transfemoral cardiac catheterization; however, its effects and safety among patients with high bleeding tendency are unknown.
OBJECTIVE


To investigate whether body positioning could decrease back pain without increasing the chance of bleeding after transcatheter arterial chemoembolization.
DESIGN


A single-blind randomized controlled trial (ClinicalTrials.gov No.: NCT03784469).
METHODS


A total of 78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled. Each person was randomly assigned to either the control or intervention group (each consisted of 39 participants). The control group received the usual care, remaining flat and lying in a supine position, whereas the intervention group had their positions changed in the second and fourth hour after chemoembolization. Participants' pain level was rated by using numerical rating scale -11 (score from 0 to 10), bleeding was measured by using volume of blood (cc.) in gauze and hematoma size in diameter (cm), and satisfaction was self-rated from 1 to 5. Repeated-measure analysis of variance (ANOVA) was used to compare the difference in pain levels over time within each group and independent t test to compare the mean difference of pain between groups at 5 endpoints, both methods with Bonferroni adjustment. Independent t test, chi-squared test, and Fisher's exact test compared postembolization discomfort, puncture sites bleeding, satisfaction between groups.
RESULTS


Significant changes of pain levels over time in both intervention [F(2.93, 111.20)=7.64, p<.001] and control groups [F(2.66, 101.17)=20.55, p<.001]. The intervention group had a significantly lower mean pain score in the second hour (t = -2.838, p = .006) and fourth hour (t = -4.739, p < .001) when patients turning to the side than did the control group lying supine. Furthermore, patients in the intervention group had significantly higher satisfaction than did those in the control group (t = -2.422, p = .018). No hematoma and significant difference of post-procedural bleeding between groups.
CONCLUSION


Changing patients' body positions in bed after transcatheter arterial chemoembolization is a safe and effective method of decreasing back pain, and increasing patients' satisfaction, without increasing the complications of bleeding and hematoma. Clinicians should change the positions of people with hepatocellular carcinoma 2 hours after they receive transcatheter arterial chemoembolization.",2020,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","['people with hepatocellular carcinoma', '78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled', 'People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain', 'people with transfemoral cardiac catheterization']","['body positioning', 'transcatheter arterial chemoembolization']","['pain level', 'pain levels', 'back pain', 'numerical rating scale -11', 'bleeding', 'mean pain score', 'higher satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",78.0,0.143191,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","[{'ForeName': 'Kai-Ting', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: kaiting105866@gmail.com.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National, Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: cjliu@ntu.edu.tw.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'Post-Baccalaureate Program in Nursing, Taipei Medical University, No. 250 Wu-Xing Street, Taipei City, 110, Taiwan. Electronic address: hsiuting@tmu.edu.tw.'}, {'ForeName': 'Tse-Pin', 'Initials': 'TP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: 021077@ntuh.gov.tw.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: nate770407@gmail.com.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Nursing, National Yang-Ming University, No.155, Sec.2, Li-Nong Street, Taipei City, 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103641']
1750,32526490,Creativity on tap 2: Investigating dose effects of alcohol on cognitive control and creative cognition.,"This preregistered study aimed to replicate and extend research on the role of cognitive control in creative cognition by examining dose effects of alcohol in a randomized controlled trial. A sample of 125 participants was randomly assigned to three experimental groups, either drinking alcoholic beer (BAC = 0.03 or 0.06) or drinking non-alcoholic beer (placebo-control group). Before and after the alcohol intervention, participants completed two tests of cognitive control and two established creative thinking tasks. A BAC of 0.06 led to an impairment of verbal fluency, while working memory performance was unaffected at both alcohol levels. Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity. These results indicate that moderate alcohol levels have dose-dependent, selective effects on cognitive control, and that minor impairments of cognitive control do not generally increase or attenuate creative thinking performance.",2020,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.",['A sample of 125 participants'],"['drinking alcoholic beer (BAC\xa0=\xa00.03 or 0.06) or drinking non-alcoholic beer (placebo-control group', 'alcohol', 'cognitive control and two established creative thinking tasks']","['creative thinking performance', 'verbal fluency, while working memory performance', 'RAT performance, divergent thinking fluency or divergent thinking creativity', 'cognitive control and creative cognition']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",125.0,0.0319793,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: mathias.benedek@uni-graz.at.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Zöhrer', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102972']
1751,32526606,Choosing vaginal birth after caesarean section: Motivating factors.,"OBJECTIVES


to examine the factors that motivate women who have had a previous caesarean section to consider planning a vaginal birth.
DESIGN


a qualitative descriptive study with thematic analysis, drawing on interviews with women participating in a two arm, un-blinded randomised controlled trial (RCT) of midwifery continuity of care for increasing the proportion of women planning VBAC.
SETTING


A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia.
PARTICIPANTS


a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth.
FINDINGS


These women were committed to natural birth and drew on their previous experience of caesarean section to highlight the downside of recovery post caesarean section. Decision making for these women was complex. During the decision-making process, women individualised the information provided to balance risk and chance within the context of their own circumstance. Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians.
CONCLUSIONS


Recovery post caesarean section is an important consideration that is under emphasised in the informed consent process. There is opportunity for midwives to contribute proactively in promoting vaginal birth for women who have experienced a previous caesarean section.
IMPLICATIONS FOR PRACTICE


women should be assisted to make informed choices with balanced information that includes recovery from surgical birth. Models of care that include a significant role for midwives and strategies that proactively encourage vaginal birth for women after previous caesarean section are needed.",2020,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians.
","['A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia', 'a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth', 'motivate women who have had a previous caesarean section to consider planning a vaginal birth', 'women who have experienced a previous caesarean section']",[],[],"[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",[],[],18.0,0.0830958,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians.
","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'University of Canberra and ACT Government Health Directorate, Faculty of Health, Bruce, 2617, ACT, Australia. Electronic address: Deborah.davis@canberra.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'S Homer', 'Affiliation': 'Maternal and Child Health Program, Burnet Institute, Melbourne, Australia; Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Clack', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Sabera', 'Initials': 'S', 'LastName': 'Turkmani', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Maralyn', 'Initials': 'M', 'LastName': 'Foureur', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia; Hunter New England Local Health District & University of Newcastle, NSW, Australia.'}]",Midwifery,['10.1016/j.midw.2020.102766']
1752,32531482,A Feasibility Study of a Randomized Controlled Trial of Asthma-Tailored Pulmonary Rehabilitation Compared with Usual Care in Adults with Severe Asthma.,"BACKGROUND


Currently, the acceptability and efficacy of pulmonary rehabilitation for adults with severe asthma is unknown.
OBJECTIVE


To investigate the feasibility of performing a randomized controlled trial of asthma-tailored pulmonary rehabilitation (AT-PR) versus usual care (UC).
METHODS


Adults with severe asthma were recruited and randomized 2:1 to AT-PR and UC. The primary outcomes were recruitment, retention, and serious adverse event rates. Secondary outcome measures included those for a future trial assessing the feasibility of collecting data. Assessments were performed at baseline, 12 weeks, and 9 months including measures of physical performance, health-related quality of life, and asthma control. A recruitment rate of 30% was estimated with 95% CI of ±7%, a retention rate of 75% ± 14% if we recruited 40 patients to AT-PR, and a serious adverse event rate of 2.5%.
RESULTS


Sixty-one (26%) of 238 eligible patients were recruited (38 women; mean age, 54 ± 13 years; body mass index, 32 ± 7 kg/m 2 ; FEV 1 , 1.9 ± 0.7 L; FEV 1 /forced vital capacity, 69% ± 11%). Fifty-one patients were randomized to AT-PR (n = 34) and UC (n = 17). The retention rate was 62% for the AT-PR group and 53% for the UC group, with a serious adverse event rate of 3.3% related to the study visits. Overall collection of the outcome measures was feasible. The results of the AT-PR group were suggestive of improvements in exercise performance, health-related quality of life, and asthma control, but the UC group results were either unchanged or worsened.
CONCLUSIONS


Both recruitment and retention rates were within the a priori estimated 95% CI. Our results indicate that AT-PR may be efficacious for adults with severe asthma but any future intervention and trial design would need further modifications to improve acceptability and retention rate.",2020,"Assessments were performed at baseline, 12 weeks and nine months including measures of physical performance, health-related quality of life (HRQoL), and asthma control.","['eligible patients were recruited: 38 females, mean (SD) age 54 (13)years, BMI 32 (7)kg/m 2 , FEV 1  1.9 (0.7)L', 'Adults with severe asthma', 'adults with severe asthma']","['asthma-tailored PR (AT-PR) versus usual care (UC', 'FVC 69', 'usual care', 'asthma-tailored pulmonary rehabilitation', 'UC', 'pulmonary rehabilitation (PR']","['exercise performance, HRQoL and asthma control with AT-PR', 'physical performance, health-related quality of life (HRQoL), and asthma control', 'acceptability and retention rate', 'retention rates', 'retention rate', 'feasibility of collecting data', 'recruitment, retention and serious adverse event rates (SAE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.171781,"Assessments were performed at baseline, 12 weeks and nine months including measures of physical performance, health-related quality of life (HRQoL), and asthma control.","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Majd', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, United Kingdom; Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Apps', 'Affiliation': 'Faculty of Health & Life Sciences, Institute for Psychological Sciences, DeMontfort University, Leicester, United Kingdom.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Chantrell', 'Affiliation': 'Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Hudson', 'Affiliation': 'Centre for Reproduction Research, Applied Social Science, DeMontfort University, Leicester, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Eglington', 'Affiliation': 'Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Hargadon', 'Affiliation': 'Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': 'Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, United Kingdom; Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, United Kingdom; Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Ruth H', 'Initials': 'RH', 'LastName': 'Green', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, United Kingdom; Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Evans', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, United Kingdom; Leicester NIHR, Biomedical Research Centre-Respiratory Theme, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, United Kingdom. Electronic address: re66@leicester.ac.uk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.05.052']
1753,32532328,Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham.,"BACKGROUND


People with chronic low back pain (LBP) typically have increased pain sensitivity compared to healthy controls, however its unknown if pain sensitivity differs based on LBP trajectory at baseline or after manual therapy interventions. We aimed to compare baseline pressure pain threshold (PPT) and temporal summation (TS) between people without LBP, with episodic LBP, and with persistent LBP, and to compare changes over time in PPT and TS after a lumbar spinal manipulation or sham manipulation in those with LBP.
METHODS


Participants were aged 18-59, with or without LBP. Those with LBP were categorised as having either episodic or persistent LBP. PPT and TS were tested at baseline. LBP participants then received a lumbar spinal manipulation or sham, after which PPT and TS were re-tested three times over 30 min. Generalised linear mixed models were used to analyse data.
RESULTS


One hundred participants (49 female) were included and analysed. There were 20 non-LBP participants (mean age 31 yrs), 23 episodic LBP (mean age 35 yrs), and 57 persistent LBP (mean age 37 yrs). There were no significant differences in PPT or TS between groups at baseline. There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability. Changes in PPT and TS after the interventions did not differ between the two LBP groups.
DISCUSSION


We found no differences between people with no LBP, episodic LBP, or persistent LBP in baseline PPT or TS. Changes in PPT and TS following a lumbar manual therapy intervention do not appear to differ between LBP trajectories.
TRIAL REGISTRATION


The trial was prospectively registered with ANZCTR (ACTRN12617001094369).",2020,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","['people without LBP, with episodic LBP, and with persistent LBP', 'One hundred participants (49 female) were included and analysed', 'Participants were aged 18-59, with or without LBP', '20 non-LBP participants (mean age 31\u2009yrs), 23 episodic LBP (mean age 35\u2009yrs), and 57 persistent LBP (mean age 37\u2009yrs', 'adults with episodic and persistent low back pain trajectories', 'People with chronic low back pain (LBP']","['LBP', 'lumbar spinal manipulation']","['PPT or TS', 'pain sensitivity', 'Pressure pain threshold and temporal summation', 'baseline pressure pain threshold (PPT) and temporal summation (TS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0443150', 'cui_str': 'Baseline pressure'}]",100.0,0.151039,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia. sasha.aspinall@murdoch.edu.au.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00326-5']
1754,32534120,Effect of traditional Chinese medicine formula GeGen decoction on primary dysmenorrhea: A randomized controlled trial study.,"ETHNOPHARMACOLOGICAL RELEVANCE


GeGen Decoction, a well-known Chinese herbal formula, is widely used in China and other Asian countries to treat gynecological diseases, including primary dysmenorrhea. Pharmacological studies have confirmed that GeGen Decoction is able to inhibit spasmodic contractions of the uterus in vivo and in vitro.
AIM OF THE STUDY


The objective of this study is to examine the efficacy and safety of GeGen Decoction on primary dysmenorrheic patients.
METHODS


This was a randomized, double-blinded, placebo-controlled trial. GeGen Decoction or placebo was administered a week before the expected start of each cycle for three consecutive menstrual periods. Between-group differences in pain intensity were detected by visual analogue scale (VAS). In addition, serum levels of arginine vasopressin (AVP) and estrogen (E) were examined by enzyme-linked immunosorbent assay. Metabolomic analysis was further used to evaluate the influence of GeGen Decoction on the metabolomics of primary dysmenorrheic patients.
RESULTS


A total of 71 primary dysmenorrheic women were recruited and 30 participants met the criteria were randomized into GeGen Decoction or placebo group. After three consecutive menstrual cycles' treatments, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group. Both serum levels of AVP and E decreased after GeGen Decoction administration, while the placebo seemed to have little effect on either of the index. Moreover, after GeGen Decoction treatment, seven important metabolites were identified by metabolomic analysis compared to the placebo group. No abnormalities in blood biochemical and routine physical examination pre and post GeGen Decoction intervention were observed.
CONCLUSIONS


GeGen Decoction can remarkably relieve the severity of menstrual pain without obvious adverse effects. Its therapeutic effect on primary dysmenorrhea might be related to the regulation of pituitary hypothalamic ovarian hormones, and interfering with the metabolic change.",2020,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","['primary dysmenorrhea', 'primary dysmenorrheic patients', '71 primary dysmenorrheic women were recruited and 30 participants met the criteria']","['GeGen Decoction', 'traditional Chinese medicine formula GeGen decoction', 'GeGen Decoction or placebo', 'placebo']","['VAS score', 'pain intensity', 'blood biochemical and routine physical examination pre and post GeGen Decoction intervention', 'visual analogue scale (VAS', 'serum levels of arginine vasopressin (AVP) and estrogen (E', 'serum levels of AVP and E', 'efficacy and safety', 'severity of menstrual pain']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",71.0,0.369829,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","[{'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Shanxi University, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Hospital Affiliated to Shanxi University of Traditional Chinese Medicine, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China. Electronic address: liuzhigang729@seu.edu.cn.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China. Electronic address: boyangyu59@163.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113053']
1755,32534175,"Three novel prevention, diagnostic, and treatment options for COVID-19 urgently necessitating controlled randomized trials.","PURPOSE


Asymptomatic or minimally symptomatic infection with COVID-19 can result in silent transmission to large numbers of individuals, resulting in expansion of the pandemic with a global increase in morbidity and mortality. New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
HYPOTHESIS


A hypothetical three-part prevention, diagnostic, and treatment approach based on an up-to-date scientific literature review for COVID-19 is proposed. Regarding diagnosis, a validated screening questionnaire and digital app for COVID-19 could help identify individuals who are at risk of transmitting the disease, as well as those at highest risk for poor clinical outcomes. Global implementation and online tracking of vital signs and scored questionnaires that are statistically validated would help health authorities properly allocate essential health care resources to test and isolate those at highest risk for transmission and poor outcomes. Second, regarding prevention, no validated protocols except for physical distancing, hand washing, and isolation exist, and recently ivermectin has been published to have anti-viral properties against COVID-19. A randomized trial of ivermectin, and/or nutraceuticals that have been published to support immune function including glutathione, vitamin C, zinc, and immunomodulatory supplements (3,6 Beta glucan) could be beneficial in preventing transmission or lessening symptomatology but requires statistical validation. Third, concerning treatment, COVID-19 induced inflammation and ""cytokine storm syndrome"" with hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) have resulted in extreme morbidity and mortality in those with certain comorbidities, secondary to ""acute respiratory distress syndrome"" (ARDS) and multiorgan dysfunction with disseminated intravascular coagulation (DIC). Deficiency in red blood cell, serum and alveolar glutathione has been published in the medical literature for ARDS, as well as viral and bacterial pneumonias, resulting from increased levels of free radical/oxidative stress. A randomized controlled trial of blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione with associated anti-viral effects should be performed, along with an evaluation of Nrf2 activators (curcumin, sulforaphane glucosinolate) which have been scientifically proven to lower inflammation. Since high mortality rates from sepsis induced DIC due to COVID-19 infection has also been associated with thrombotic events and elevated levels of D-dimer, randomized controlled trials of using anticoagulant therapy with heparin is urgently required. This is especially important in patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria. The use of acetazolamide with or without sildenafil also needs to be explored with or without heparin, since increased oxygen delivery to vital organs through prevention of thrombosis/pulmonary emboli along with carbonic anhydrase inhibition may help increase oxygenation and prevent adverse clinical outcomes.
CONCLUSION AND IMPLICATIONS


A three-part prevention, diagnostic, and treatment plan is proposed for addressing the severe complications of COVID-19. Digital monitoring of symptoms to clinically diagnose early exposure and response to treatment; prevention with ivermectin as well as nutritional therapies that support a healthy immune response; treatment with anti-inflammatory therapies that block NF-κB and activate Nrf2 pathways, as well as novel therapies that address COVID-19 pneumonia and ARDS with DIC including anticoagulation and/or novel respiratory therapies with or without acetazolamide and sildenafil. These three broad-based interventions urgently need to be subjected to randomized, controlled trials.",2020,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
",['patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria'],"['ivermectin', 'acetazolamide and sildenafil', 'heparin', 'hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS', 'acetazolamide with or without sildenafil', 'blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2603364', 'cui_str': 'On ventilator'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0024291', 'cui_str': 'Hemophagocytic lymphohistiocytosis'}, {'cui': 'C1868709', 'cui_str': 'Activation syndrome'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",[],,0.0711722,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Horowitz', 'Affiliation': 'HHS Babesia and Tickborne Pathogen Subcommittee, Washington, D.C. 20201, USA; Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA. Electronic address: medical@hvhac.com.'}, {'ForeName': 'Phyllis R', 'Initials': 'PR', 'LastName': 'Freeman', 'Affiliation': 'Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109851']
1756,32534221,The three-year effect of a single zoledronate infusion on bone mineral density and bone turnover markers following denosumab discontinuation in women with postmenopausal osteoporosis.,"INTRODUCTION


In women with postmenopausal osteoporosis denosumab discontinuation is associated with rapid bone loss that could be potentially prevented by a single zoledronate infusion for two years. The longer-term effects, however, of zoledronate treatment are unknown. We aimed to study the effect of a single zoledronate infusion during the third year following denosumab discontinuation, in initially treatment-naive postmenopausal women who became osteopenic after 2.4 ± 0.2 years of denosumab therapy.
METHODS


We report the 1-year follow-up results of a single arm observational extension of a previously reported 2-year multicenter prospective randomized clinical trial. The primary endpoint of this extension was the change in lumbar spine bone mineral density (LS-BMD); secondary endpoints were changes in femoral neck (FN)-BMD and markers of bone turnover (BTM) during the 3rd year from the zoledronate infusion. Changes are presented as mean and SEM.
RESULTS


LS-BMD did not change significantly at year 3 compared to year 2 (-1.35 ± 1.1%, p = 1.00) and compared to baseline (-1.96 ± 1.44%, p = 1.00). FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up. In 4 of the 23 studied women BMD values returned to the osteoporotic range at 3 years.
CONCLUSIONS


A single i.v. infusion of zoledronate 5 mg, given 6 months after the last injection of denosumab therapy maintains for three years BMD gains in the majority of patients previously treated with denosumab for an approximate period of 2.5 years. Follow-up of patients is, however, recommended because about one-fifth of treated women will require additional antiosteoporotic treatment.",2020,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"['women with postmenopausal osteoporosis', 'initially treatment-naive postmenopausal women who became osteopenic after 2.4\u202f±\u202f0.2\u202fyears of denosumab therapy']","['single zoledronate infusion', 'zoledronate infusion', 'denosumab', 'zoledronate', 'denosumab discontinuation']","['CTX values', 'femoral neck (FN)-BMD and markers of bone turnover (BTM', 'FN-BMD values', 'lumbar spine bone mineral density (LS-BMD', 'bone mineral density and bone turnover markers', 'LS-BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",23.0,0.0926873,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"[{'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece. Electronic address: a.anastasilakis@gmail.com.'}]",Bone,['10.1016/j.bone.2020.115478']
1757,32540720,Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis.,"OBJECTIVE


The gait recovery in spinal cord injury (SCI) seems to be partially related to the reorganization of cerebral function; however, the neural mechanisms and the respective biomarkers are not well known. This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI. We tested this hypothesis at baseline in SCI subjects and also in response to cortical stimulation with transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT).
METHODS


In this neurophysiological analysis of a randomized controlled trial, thirty-nine patients with incomplete SCI were included. They received 30 sessions of either active or sham anodal tDCS over the primary motor area for 20 min combined with RAGT. We analyzed the Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II). Univariate and multivariate linear/logistic regression analyses were performed to identify the predictors of gait function and recovery.
RESULTS


Consistent with our hypothesis, we found that in the sensorimotor area: (1) Anodal tDCS combined with RAGT can modulate high-beta EEG oscillations power and enhance gait recovery; (2) higher high-beta EEG oscillations power at baseline can predict baseline gait function; (3) high-beta EEG oscillations power at baseline can predict gait recovery - the higher power at baseline, the better gait recovery; (4) decreases in relative high-beta power and increases in beta power decrease during walking are associated with gait recovery.
CONCLUSIONS


Enhanced EEG beta oscillations in the sensorimotor area in SCI subjects may be part of a compensatory mechanism to enhance local plasticity. Our results point to the direction that interventions enhancing local plasticity such as tDCS combined with robotic training also lead to an immediate increase in sensorimotor cortex activation, improvement in gait recovery, and subsequent decrease in high-beta power. These findings suggest that beta-band oscillations may be potential biomarkers of gait function and recovery in SCI.
SIGNIFICANCE


These findings are significant for rehabilitation in SCI patients, and as EEG is a portable, inexpensive, and easy-to-apply system, the clinical translation is feasible to follow better the recovery process and to help to individualize rehabilitation therapies of SCI patients.",2020,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"['thirty-nine patients with incomplete SCI were included', 'spinal cord injury patients', 'SCI subjects', 'spinal cord injury (SCI', 'SCI patients']","['active or sham anodal tDCS over the primary motor area for 20\xa0min combined with RAGT', 'transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT']","['high-beta EEG oscillations power and enhance gait recovery', 'Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II', 'gait recovery', 'sensorimotor cortex activation']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}]",39.0,0.0972225,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Simis', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur-Kucukseymen', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud. Lima, Peru.'}, {'ForeName': 'Linamara R', 'Initials': 'LR', 'LastName': 'Battistella', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: Fregni.Felipe@mgh.harvard.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.04.166']
1758,32542578,Does Organizing Mentor-Mentee Matches into Small Groups Enhance Treatment Effects in a Site-Based Mentoring Program for Adolescents? Results of a Randomized Controlled Trial.,"Formal youth mentoring is an effective intervention strategy for healthy development during adolescence. Modest and varied effects across programs, however, demonstrate a need to identify factors that can reliably improve outcomes for mentored youth. The purpose of this randomized controlled trial was to test the relative impact of embedding mentee-mentor matches in small groups on youth outcomes and to examine whether this effect was mediated by the quality of the program setting and mentoring relationship quality. Participants included 676 adolescents (M age  = 14.21, range = 11-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program. Most measured outcomes in both conditions (i.e., mentoring groups and a control condition in which pairs were not embedded in a group) were significantly better at post-intervention as compared to pre-intervention. The hypothesis that mentoring groups would have stronger impact, however, was not supported. The results imply that organizing mentor-mentee matches in small groups offer no advantage or disadvantage and that youth may be able to garner benefit from both structures.",2020,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","['Participants included 676 adolescents (M age \u2009=\u200914.21, range\u2009=\u200911-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program', 'healthy development during adolescence']",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",[],[],676.0,0.0674145,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Haddock', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA. shelley.haddock@colostate.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota, St. Paul, MN, 55108, USA.'}, {'ForeName': 'Hyanghee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Toni S', 'Initials': 'TS', 'LastName': 'Zimmerman', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Krafchick', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gereon F', 'Initials': 'GF', 'LastName': 'Fredrickson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Yetz', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Youngblade', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01267-1']
1759,32542627,Vitamin D in Type 2 Diabetes: Genetic Susceptibility and the Response to Supplementation.,"Variants of vitamin D metabolism-genes may predispose to type 2 diabetes (T2D). This study investigated the impact of these variants on disease susceptibility, Vitamin D, parathyroid hormone, C-peptide and HbA1c levels before and after cholecalciferol supplementation in patients with T2D.Twelve polymorphisms within CYP2R1, CYP27B1, DBP, VDR and CYP24A1 were genotyped in 553 T2D patients and 916 controls. In addition 65 patients receiving either cholecalciferol or placebo were analyzed during 6 months intervention and 6 months follow-up.T2D risk alleles are VDR rs7975232 ""G"" (p c =0.031), rs1544410 ""G"" (p c =0.027) and CYP2R1 rs10741657 ""A"" (p c =0.016). Patients with genotypes CYP27B1 rs10877012 ""CC"" (p c =4x10 -5 ), DBP rs7041 ""GG"" (p c =0.003), rs4588 ""CC"" (p c  = 3x10 -4 ), CYP24A1 rs2585426 ""CG"" (p c =0.006) and rs2248137 ""CG"" (p c =0.001) showed lower 25(OH)D3 and DBP rs4588 ""CC"" lower 1,25(OH)2D3 levels (p c =0.005). Whereas DBP rs4588 ""CC"" (p c =0.009), CYP27B1 rs10877012 ""AC"" (p c =0.059), VDR rs7975323 ""AG"" (p c =0.033) and rs1544410 ""GG"" (p c =0.013) are associated with higher 25(OH)D3 levels at 6 months' follow-up. Significant PTH suppression was detected for CYP2R1 ""AG"" (p c =0.002), DBP rs4588 ""CC"" (p c <0.001), VDR rs110735810 ""CT"" (p c <0.001) and CYP24A1 rs2248137 ""GG"" (p c =0.021).Genetic variants of the vitamin D system predispose to type 2 diabetes and regulate - partially - vitamin D metabolism, concentrations and the vitamin D status. Vitamin D insufficiency is a T2D risk factor. The response to cholecalciferol supplementation can be measured as 25(OH)D3 increment and PTH suppression. This process is regulated by genes of the vitamin D system conferring modest T2D risk.",2020,"Significant PTH suppression was detected for CYP2R1 ""AG"" (p c =0.002), DBP rs4588 ""CC"" (p c <0.001), VDR rs110735810 ""CT"" (p c <0.001) and CYP24A1 rs2248137 ""GG"" (p c =0.021).Genetic variants of the vitamin D system predispose to type 2 diabetes and regulate - partially - vitamin D metabolism, concentrations and the vitamin D status.","['Type 2 Diabetes', 'Patients with genotypes', 'patients with T2D.Twelve polymorphisms within CYP2R1, CYP27B1, DBP, VDR and CYP24A1 were genotyped in 553 T2D patients and 916 controls', '65 patients receiving either']","['cholecalciferol supplementation', 'cholecalciferol or placebo', 'Vitamin D']","['DBP rs4588 ""CC', '25(OH)D3 levels', 'VDR rs7975323 ""AG', 'CYP2R1 ""AG', '25(OH)D3 and DBP rs4588 ""CC"" lower 1,25(OH)2D3 levels', '25(OH)D3 increment and PTH suppression', 'CYP27B1 rs10877012 ""AC', 'disease susceptibility, Vitamin D, parathyroid hormone, C-peptide and HbA1c levels', 'VDR rs110735810 ""CT', 'Significant PTH suppression']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C1827418', 'cui_str': 'Cytochrome p450 CYP2R1 enzyme'}, {'cui': 'C0000340', 'cui_str': 'Calcidiol 1-monooxygenase'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C3657722', 'cui_str': 'VDR protein, human'}, {'cui': 'C0283470', 'cui_str': '1 alpha,25-Dihydroxycholecalciferol-24-Hydroxylase'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3657722', 'cui_str': 'VDR protein, human'}, {'cui': 'C1827418', 'cui_str': 'Cytochrome p450 CYP2R1 enzyme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0000340', 'cui_str': 'Calcidiol 1-monooxygenase'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0456524,"Significant PTH suppression was detected for CYP2R1 ""AG"" (p c =0.002), DBP rs4588 ""CC"" (p c <0.001), VDR rs110735810 ""CT"" (p c <0.001) and CYP24A1 rs2248137 ""GG"" (p c =0.021).Genetic variants of the vitamin D system predispose to type 2 diabetes and regulate - partially - vitamin D metabolism, concentrations and the vitamin D status.","[{'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Klahold', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Penna-Martinez', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Bruns', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seidl', 'Affiliation': 'German Red Cross Blood Donor Service, Institute for Transfusion Medicine and Immunohaematology, Frankfurt/Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wicker', 'Affiliation': 'Occupational Health Service, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Badenhoop', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}]",Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme,['10.1055/a-1157-0026']
1760,32535984,Impact of parents' mental-health-related stigma on their adolescent children' response to anti-stigma interventions over 24 months: Secondary exploratory analysis of a randomized controlled trial.,,2020,,"[""parents' mental health-related stigma on their adolescent children's""]",['anti-stigma interventions'],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.193345,,"[{'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sosei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Community Mental Health & Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Neuropsychiatry, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Koike', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13085']
1761,32546239,A prospective longitudinal study on the microbiota composition in amyotrophic lateral sclerosis.,"BACKGROUND


A connection between amyotrophic lateral sclerosis (ALS) and altered gut microbiota composition has previously been reported in animal models. This work is the first prospective longitudinal study addressing the microbiota composition in ALS patients and the impact of a probiotic supplementation on the gut microbiota and disease progression.
METHODS


Fifty patients and 50 matched controls were enrolled. The microbial profile of stool samples from patients and controls was analyzed via PCR-Denaturing Gradient Gel Electrophoresis, and the main microbial groups quantified via qPCR. The whole microbiota was then analyzed via next generation sequencing after amplification of the V3-V4 region of 16S rDNA. Patients were then randomized to receive probiotic treatment or placebo and followed up for 6 months with ALSFRS-R, BMI, and FVC%.
RESULTS


The results demonstrate that the gut microbiota of ALS patients is characterized by some differences with respect to controls, regardless of the disability degree. Moreover, the gut microbiota composition changes during the course of the disease as demonstrated by the significant decrease in the number of observed operational taxonomic unit during the follow-up. Interestingly, an unbalance between potentially protective microbial groups, such as Bacteroidetes, and other with potential neurotoxic or pro-inflammatory activity, such as Cyanobacteria, has been shown. The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
CONCLUSIONS


Our study poses the bases for larger clinical studies to characterize the microbiota changes as a novel ALS biomarker and to test new microbial strategy to ameliorate the health status of the gut.
TRIAL REGISTRATION


CE 107/14, approved by the Ethics Committee of the ""Maggiore della Carità"" University Hospital, Italy.",2020,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","['Fifty patients and 50 matched controls were enrolled', 'amyotrophic lateral sclerosis', 'ALS patients']","['probiotic supplementation', 'probiotic treatment or placebo']","['gut microbial composition', 'gut microbiota composition changes', 'biodiversity of intestinal microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282469', 'cui_str': 'Biological Diversity'}]",50.0,0.0171276,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Di Gioia', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bozzi Cionci', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Baffoni', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Amoruso', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pane', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mogna', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gaggìa', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Maria Ausiliatrice', 'Initials': 'MA', 'LastName': 'Lucenti', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Bersano', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cantello', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'De Marchi', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Mazzini', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. letizia.mazzini@uniupo.it.'}]",BMC medicine,['10.1186/s12916-020-01607-9']
1762,32544269,Evaluation of preventive laser photobiomodulation in patients with head and neck cancer undergoing radiochemotherapy: Laser in patients with head and neck cancer.,"AIMS


This study aimed to evaluate the effect of laser photobiomodulation in the prevention of oral mucositis (OM), salivary hypofunction and referred pain in patients with head and neck cancer.
METHODS AND RESULTS


This randomized clinical study divided patients into two groups: the laser group (LG, n = 30) and the control group (CG, n = 24). The LG (InGaAlP, 660 nm, 86.7 mW, 2 J/cm 2  ) participated in the preventive protocol, while the CG underwent a simulated procedure without light emission. The degree of OM, salivary flow, and referred pain were evaluated at five different periods of radiotherapy. Both groups showed a significant increase in the degree of OM (P < .01). Regarding OM, salivary flow, and oral pain, there were no significant differences between the groups.
CONCLUSIONS


The laser photobiomodulation protocol used in this study was not effective in preventing radiochemotherapy-induced OM, salivary hypofunction, and referred pain in patients with head and neck cancer. Notably, although the development of OM did not differ significantly according to the use of laser therapy, the severity of oral mucositis was reduced in patients who underwent laser therapy compared to that in patients who did not.",2020,Both groups showed a significant increase in the degree of OM (P < .01).,"['patients with head and neck cancer', 'patients with head and neck cancer undergoing']","['laser therapy', 'radiochemotherapy', 'preventive laser photobiomodulation', 'laser photobiomodulation']","['oral mucositis (OM), salivary hypofunction and referred pain', 'severity of oral mucositis', 'degree of OM', 'OM, salivary flow, and oral pain', 'degree of OM, salivary flow, and referred pain', 'OM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0234250', 'cui_str': 'Referred pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}]",,0.020856,Both groups showed a significant increase in the degree of OM (P < .01).,"[{'ForeName': 'Juliana Borges de Lima', 'Initials': 'JBL', 'LastName': 'Dantas', 'Affiliation': 'Masters in Dentistry at Bahiana School of Medicine and Public Health, Salvador, Bahia, Brazil.'}, {'ForeName': 'Gabriela Botelho', 'Initials': 'GB', 'LastName': 'Martins', 'Affiliation': 'Associate Professor of Health Sciences Institute of the Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Hayana Ramos', 'Initials': 'HR', 'LastName': 'Lima', 'Affiliation': 'Adjunct Professor, Center of Health Sciences, Federal University of Southern Bahia, Teixeira de Freitas, Bahia, Brazil.'}, {'ForeName': 'Manoela', 'Initials': 'M', 'LastName': 'Carrera', 'Affiliation': 'Adjunct Professor of Stomatology at the Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Sílvia Regina de Almeida', 'Initials': 'SRA', 'LastName': 'Reis', 'Affiliation': 'Adjunct Professor at Bahiana - School of Medicine and Public Health, Salvador, Bahia, Brazil.'}, {'ForeName': 'Alena Ribeiro Alves Peixoto', 'Initials': 'ARAP', 'LastName': 'Medrado', 'Affiliation': 'Adjunct Professor at Bahiana - School of Medicine and Public Health, Salvador, Bahia, Brazil.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12486']
1763,32545396,"An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: A Placebo-Controlled, Double-Blind, Randomized Clinical Trial.","BACKGROUND


Certain dietary fibers have been reported to improve gut health and cellular immunity. Ambrotose is a glyconutrient supplement that contains mannose-rich polysaccharides (acemannan), reported to improve immune function. A more nutrient-dense version of this dietary supplement has been developed recently, with added aloe leaf gel powder (acemannan). The purpose of this study was to evaluate the impact of the traditional and newly developed Ambrotose products on immunity, gut health, and psychological well-being in healthy men and women.
METHODS


Seventy-five men and women were randomly assigned in double-blind manner to one of five treatments, as follows: Ambrotose Advanced (AA) at 2 or 4 g daily, Ambrotose LIFE (AL) at 2 or 4 g daily, or placebo. Subjects ingested their assigned treatment daily for eight weeks. Resting heart rate, blood pressure, and measures of psychological well-being were analyzed before and after four and eight weeks of supplementation. Blood samples were collected at the same times and analyzed for zonulin, hematology measures, and cytokines-IL-6, IL-10, IL-1β, and TNF-α (analyzed both with and without stimulation via lipopolysaccharide [LPS]).
RESULTS


All Ambrotose treatments were well-tolerated. There were no differences among treatments in heart rate or blood pressure across time. Self-reported well-being scores were generally higher for the Ambrotose treatments but there were no changes of statistical significance across time ( p  > 0.05). Differences of statistical significance were noted for select biochemical variables, the most notable being a dramatic decrease in monocytes in the Ambrotose groups. No change was noted in the cytokine response to LPS stimulation in all groups, indicating a maintenance of a healthy immune response.  Conclusion:  Regular supplementation with Ambrotose is safe and can improve subclinical cellular adversity (as evidenced by a decrease in monocytes), without unnecessary activation of an immune response.",2020,Self-reported well-being scores were generally higher for the Ambrotose treatments but there were no changes of statistical significance across time ( p  > 0.05).,"['Seventy-five men and women', 'healthy men and women', 'Men and Women']","['Regular supplementation with Ambrotose', 'Ambrotose Advanced (AA) at 2 or 4 g daily, Ambrotose LIFE (AL) at 2 or 4 g daily, or placebo', 'Placebo']","['tolerated', 'Resting heart rate, blood pressure, and measures of psychological well-being', 'Self-reported well-being scores', 'immunity, gut health, and psychological well-being', 'Immunity, Gut Health, and Safety', 'zonulin, hematology measures, and cytokines-IL-6, IL-10, IL-1β, and TNF-α', 'heart rate or blood pressure across time', 'cytokine response to LPS stimulation']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",75.0,0.317622,Self-reported well-being scores were generally higher for the Ambrotose treatments but there were no changes of statistical significance across time ( p  > 0.05).,"[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butawan', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'van der Merwe', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}, {'ForeName': 'Faith H', 'Initials': 'FH', 'LastName': 'Keating', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}]",Nutrients,['10.3390/nu12061751']
1764,32558044,"Efficacy of levetiracetam on upper limb movement in multiple sclerosis patients with cerebellar signs: a multicenter double-blind, placebo-controlled, crossover study.","BACKGROUND AND PURPOSE


The literature provides contrasting results on the efficacy of levetiracetam (LEV) in multiple sclerosis (MS) patients with cerebellar signs. It was sought to evaluate the efficacy of LEV on upper limb movement in MS patients.
METHODS


In this multicenter double-blind placebo-controlled crossover study, MS patients with prevalently cerebellar signs were randomly allocated into two groups: LEV followed by placebo (group 1) or placebo followed by LEV (group 2). Clinical assessments were performed by a blinded physician at T0 (day 1), T1 (day 22), T2 (2-week wash-out period, day 35) and T3 (day 56). The primary outcome was dexterity in the arm with greater deficit, assessed by the nine-hole peg test (9HPT). Secondary clinical outcomes included responders on the 9HPT (∆9HPT >20%), tremor activity of the daily living questionnaire and self-defined upper limb impairment, through a numeric rating scale. Kinematic evaluation was performed using a digitizing tablet, providing data on normalized jerk, aiming error and centripetal acceleration.
RESULTS


Forty-eight subjects (45.2 ± 10.4 years) were randomly allocated into two groups (n = 24 each). 9HPT significantly improved in the LEV phase in both groups (P < 0.001). The LEV treatment phase led to a significant improvement (P < 0.01) of all clinical outcomes in group 1 and in dexterity in group 2. No significant changes were reported during both placebo phases in the two groups. Considering the kinematic analysis, only normalized jerk significantly improved after treatment with LEV (T0-T1) in group 1.
CONCLUSIONS


Levetiracetam treatment seems to be effective in improving upper limb dexterity in MS patients with cerebellar signs.",2020,The LEV treatment phase lead to a significant improvement (p<0.01) of all clinical outcomes in Group 1 and in dexterity in Group 2.,"['MS patients with prevalently cerebellar signs', 'Forty-eight subjects (45.2±10.4 years', 'MS patients', 'multiple sclerosis (MS) patients with cerebellar signs', 'MS patients with cerebellar signs', 'multiple sclerosis patients with cerebellar signs']","['levetiracetam', 'levetiracetam (LEV', 'LEV', 'LEV (T0-T1', 'LEV followed by placebo', 'placebo followed by LEV', 'placebo']","['upper limb dexterity', '9HPT', 'dexterity in the arm with greater deficit, assessed by the nine-hole peg test (9HPT', 'upper limb movement', 'responders on the 9HPT (∆9HPT>20%), tremor activity of daily living questionnaire and self-defined upper limb impairment, through a numeric rating scale']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0529009,The LEV treatment phase lead to a significant improvement (p<0.01) of all clinical outcomes in Group 1 and in dexterity in Group 2.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Solaro', 'Affiliation': ""Rehabilitation Unit, 'Mons. L. Novarese' Hospital, Moncrivello, Italy.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': ""Rehabilitation Unit, 'Mons. L. Novarese' Hospital, Moncrivello, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Messmer Uccelli', 'Affiliation': 'Italian Multiple Sclerosis Research Foundation, Genoa, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Department of Neurology, ASL 3 Genovese, Genoa, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bergamaschi', 'Affiliation': ""Department of Neurology, Neurology Institute 'C. Mondino', Pavia, Italy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gasperini', 'Affiliation': 'Neurology Division, San Camillo Hospital, Rome, Italy.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Restivo', 'Affiliation': ""Neurological Unit, 'Garibaldi' Hospital, Catania, Italy.""}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Stabile', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, San Camillo Hospital IRCCS, Venice, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': ""Department of Medical, Surgical Science and Advanced Technology 'GF Ingrassia', University of Catania, Catania, Italy.""}]",European journal of neurology,['10.1111/ene.14403']
1765,32554105,Cost-effectiveness of a collaborative care program for managing major depression and chronic musculoskeletal pain in primary care: Economic evaluation alongside a randomized controlled trial.,"BACKGROUND


We designed a collaborative care program for the integrated management of chronic musculoskeletal pain and depression, which frequently coexist in primary care patients. The aim of this study was to evaluate the cost-effectiveness of this program compared with care as usual.
METHODS


We performed a cost-effectiveness analysis alongside a randomized clinical trial. Results were monitored over a 12-month period. The primary outcome was the incremental cost-effectiveness ratio (ICER). We performed cost-effectiveness analyses from the perspectives of the healthcare system and society using an intention-to-treat approach with imputation of missing values.
RESULTS


We evaluated 328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline. From the healthcare system perspective, the mean incremental cost was €234 (p = .17) and the mean incremental effectiveness was 0.009 QALYs (p = .66), resulting in an ICER of €23,989/QALY. Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY. These estimates were associated with a high degree of uncertainty illustrated on the cost-effectiveness plane.
CONCLUSIONS


Contrary to our expectations, the collaborative care program had no significant effects on health status, and although the additional costs of implementing the program compared with care as usual were not high, we were unable to demonstrate a favorable cost-effectiveness ratio, largely due to the high degree of uncertainty surrounding the estimates.",2020,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","['328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline', 'primary care patients', 'managing major depression and chronic musculoskeletal pain in primary care']",['collaborative care program'],"['Cost-effectiveness', 'mean incremental effectiveness', 'mean incremental cost', 'health status', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",328.0,0.0923458,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","[{'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Aragonès', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain. Electronic address: earagones.tgn.ics@gencat.cat.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sánchez-Iriso', 'Affiliation': 'Department of Economics, Public University of Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'López-Cortacans', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Tomé-Pires', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; ISCTE-Lisbon University Institute (ISCTE-IUL), Center for Social Research and Intervention (CIS-IUL), Lisbon, Portugal.""}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Rambla', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': ""Unit for the Study and Treatment of Pain - ALGOS, Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110167']
1766,32554135,The relationship between the tympanostomy tube extrusion time and viscosity.,"OBJECTIVE


The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid.
METHODS


Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded.
RESULTS


The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant.
CONCLUSION


The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time.
TRIAL REGISTRATION NUMBER


NCT03848026.",2020,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"['Patients with effusion values below and above the median viscosity value of 439\xa0cP (cP', 'Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study']",[],"['mean tube extrusion time', 'tube extrusion time and the viscosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]",33.0,0.0301946,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Degirmenci', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: ndegirmenci@bezmialem.edu.tr.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Tugrul', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: selahattintugrul@yahoo.com.'}, {'ForeName': 'Seda Sezen', 'Initials': 'SS', 'LastName': 'Goktas', 'Affiliation': '75. Yil Boyabat State Hospital, Department of Otorhinolaryngology and Head and Neck Surgery, Sinop, Turkey. Electronic address: sedasezengoktas@gmail.com.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Senturk', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: erolsent@gmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Calim', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: omercalim@yahoo.com.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Dogan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: dr.remzidogan@hotmail.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yenigun', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: alperyenigun@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ozturan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: orhanent@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110140']
1767,32538880,Efficacy of Osteopathic Manipulative Treatment on postural control in Parkinsonian patients with Pisa syndrome: A pilot randomized placebo-controlled trial.,"BACKGROUND


Pisa syndrome (PS) is a clinical condition frequently associated with Parkinson's disease (PD). It is characterized by a trunk lateral flexion higher than 10 degrees and reversible when lying. One pathophysiological hypothesis is the altered verticality perception, due to a somatosensory impairment. Osteopathic Manipulative Treatment (OMT) manages fascial-system alterations, linked to somatic dysfunctions. Fascial system showed to be implicated in proprioceptive sensibility.
OBJECTIVE


The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry.
METHODS


In this single-blinded trial we studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received four OMT plus MIRT, for one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) with DIERS formetrics was also performed.
RESULTS


At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01). In the experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).
DISCUSSION


Among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.",2020,"At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01).","['Parkinsonian patients with Pisa syndrome', 'PD-PS patients by stabilometry', '24 PD-PS patients']","['placebo', 'trunk lateral flexion (TLF', 'Osteopathic Manipulative Treatment (OMT', 'osteopathic manipulative treatment', 'multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received four OMT plus MIRT']","['mean inclination reduction', 'eye closed sway area assessment', 'OMT efficacy', 'proprioceptive sensibility', 'postural control and TLF improvement', 'delta ECSA and delta TLF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920233', 'cui_str': 'Pisa syndrome'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",24.0,0.0908228,"At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zarucchi', 'Affiliation': 'Department of Brain Injury and Parkinson\'s Disease Rehabilitation, Ospedale ""Moriggia-Pelascini"", Gravedona ed Uniti (Como), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vismara', 'Affiliation': '""Rita Levi Montalcini"" Department of Neurosciences, University of Turin, Turin, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Frazzitta', 'Affiliation': 'Department of Brain Injury and Parkinson\'s Disease Rehabilitation, Ospedale ""Moriggia-Pelascini"", Gravedona ed Uniti (Como), Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mauro', 'Affiliation': '""Rita Levi Montalcini"" Department of Neurosciences, University of Turin, Turin, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Priano', 'Affiliation': '""Rita Levi Montalcini"" Department of Neurosciences, University of Turin, Turin, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maestri', 'Affiliation': 'Department of Biomedical Engineering, Istituti Clinici Scientifici Maugeri Spa Società Benefit, IRCCS, Montescano, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bergna', 'Affiliation': 'Department of Clinical Research, SOMA Istituto Osteopatia Milano, Italy.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Tarantino', 'Affiliation': 'Department of Clinical Research, SOMA Istituto Osteopatia Milano, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203068']
1768,32538882,"Effects of innovative hip-knee-ankle interlimb coordinated robot training on ambulation, cardiopulmonary function, depression, and fall confidence in acute hemiplegia.","BACKGROUND


While Walkbot-assisted locomotor training (WLT) provided ample evidence on balance and gait improvements, the therapeutic effects on cardiopulmonary and psychological elements as well as fall confidence are unknown in stroke survivors.
OBJECTIVE


The present study aimed to compare the effects of Walkbot locomotor training (WLT) with conventional locomotor training (CLT) on balance and gait, cardiopulmonary and psychological functions and fall confidence in acute hemiparetic stroke.
METHODS


Fourteen patients with acute hemiparetic stroke were randomized into either the WLT (60 min physical therapy + 30 min Walkbot-assisted gait training) or CLT (60 min physical therapy + 30 min gait training) groups, 7 days/week over 2 weeks. Clinical outcomes included the Berg Balance Scale (BBS), Functional Ambulation Category (FAC), heart rate (HR), Borg Rating of Perceived Exertion (BRPE), Beck Depression Inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale. The analysis of covariance (ANCOVA) was conducted at P < 0.05.
RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P < 0.05), but not on BBS (P = 0.061).
CONCLUSIONS


Our results provide novel, promising clinical evidence that WLT improved balance and gait function as well as cardiopulmonary and psychological functions, and fall confidence in acute stroke survivors who were unable to ambulate independently.",2020,"RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P <  0.05), but not on BBS (P = 0.061).
","['acute hemiparetic stroke', 'Fourteen patients with acute hemiparetic stroke', 'acute hemiplegia', 'acute stroke survivors']","['Walkbot locomotor training (WLT) with conventional locomotor training (CLT', 'WLT (60-minute physical therapy +30-minute Walkbot-assisted gait training) or CLT (60\u200amin physical therapy +30\u200amin gait training', 'innovative hip-knee-ankle interlimb coordinated robot training', 'While Walkbot-assisted locomotor training (WLT', 'WLT']","['ambulation, cardiopulmonary function, depression, and fall confidence', 'balance and gait function', 'BBS', 'Berg balance scale (BBS), functional ambulation category (FAC), heart rate (HR) and Borg rating of perceived exertion (BRPE), Beck depression inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale', 'FAC, HR, BRPE, BDI-II, and ABC scale', 'balance and gait, cardiopulmonary and psychological functions and fall confidence']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0419113', 'cui_str': 'Locomotor training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}]",14.0,0.02254,"RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P <  0.05), but not on BBS (P = 0.061).
","[{'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Mooyeon', 'Initials': 'M', 'LastName': 'Oh-Park', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Dohle', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bialek', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Friel', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Moss Rehabilitation, Philadelphia, PA, USA.'}, {'ForeName': 'Hermano Igo', 'Initials': 'HI', 'LastName': 'Krebs', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Joshua Sung H', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Department of Physical Therapy, Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Yonsei University, Wonju, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-203086']
1769,32540725,Significant immunomodulatory properties of curcumin in patients with osteoarthritis; a successful clinical trial in Iran.,"Osteoarthritis (OA) routinely is known as a multifactorial degenerative joint disease. This trial aimed to assess the curcumin (an active element of turmeric) effects on the immune responses in OA patients. Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups; intervention (received Sinacurcumin® 80 mg daily) and placebo, followed for 3 months. In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency. Additionally, Treg cells indicated a significant increase and Treg/Th17 cells ratio showed a meaningfully shifted toward Treg lymphocytes. In conclusion, our data indicated that clinical manifestation was ameliorated considerably following the administration of curcumin. Moreover, our data demonstrated the immunomodulatory effects of curcumin in OA patients.",2020,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency.","['Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups', 'patients with osteoarthritis', 'OA patients']","['intervention (received Sinacurcumin® 80\xa0mg daily) and placebo', 'curcumin']","['Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.0327408,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency.","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Atabaki', 'Affiliation': 'Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Shariati-Sarabi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Tavakkol-Afshari', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: mohammadimzh@mums.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106607']
1770,32540779,Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study.,"OBJECTIVE


To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty.
STUDY DESIGN


prospective randomized study.
SETTING


Tertiary academic center.
SUBJECTS


and methods: Children with ankyloglossia with articulation difficulty were randomly divided into 2 groups for surgical treatment. Patients were evaluated for the tongue-tie classification and articulation test before surgery. Three months after the operation, the frenulum classification and articulation test were re-evaluated to compare the differences in surgical outcome between the two surgical methods.
RESULTS


Out of 37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy. No differences were observed in the baseline characteristics of the patients assigned to both groups. Changes in the tongue-tie classification and improvement in the articulation test results were observed with both the surgical methods. Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
CONCLUSION


Although there was no significant difference in the surgical outcome between the two surgical methods, ankyloglossia patients showed improvement in a Korean speech articulation test 3 months after undergoing surgery to release the lingual frenulum.",2020,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","['patients with ankyloglossia with articulation difficulty', 'ankyloglossia with articulation difficulty', 'and methods', 'Children with ankyloglossia with articulation difficulty', 'Tertiary academic center', '37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy']","['simple frenotomy and the 4-flap Z-frenuloplasty', 'simple frenotomy with 4-flap Z-frenuloplasty']","['speech articulation test', 'speech outcomes', 'surgical outcome', 'Korean speech articulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152415', 'cui_str': 'Tongue tie'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0037819', 'cui_str': 'Speech Articulation Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",37.0,0.0322658,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Don', 'Initials': 'SD', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Eun', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ygeun@khu.ac.kr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110146']
1771,32542725,Hard and soft tissue alterations during the healing stage of immediate implant placement and provisionalization with or without connective tissue graft: A randomized clinical trial.,"AIMS


To evaluate the hard and soft tissue alterations of immediately placed and provisionalized implants with or without connective tissue graft (CTG).
MATERIALS AND METHODS


Single unsalvageable maxillary incisors were replaced with immediately placed and provisionalized implants in 42 participants. The patients were randomly assigned to receive simultaneous CTG (test group) and not receive CTG (control group). Digital impression and cone-beam computed tomography images were obtained before extraction and after 6 months. Mid-facial gingival margin migrations, soft tissue contour changes and hard tissue remodelling were analysed and compared between the two groups using three-dimensional superimposition method.
RESULTS


Forty participants completed the study. The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin. In both groups, the mid-facial gingival margin migrated in an apico-palatal direction and the socket void, except for a triangular space in the bucco-coronal region, demonstrated radiographic new bone formation without statistically significant differences.
CONCLUSIONS


The CTG used with immediate implant placement and provisionalization could compensate for the facial tissue collapse, but it did not benefit maintenance of the mid-facial gingival margin position during the 6-month follow-up. New bone formation observed radiographically can be expected in most areas of the socket void, regardless of CTG use (ChiCTR-1900028494).",2020,The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin.,"[' Single unsalvageable maxillary incisors were replaced with immediately placed and provisionalized implants in 42 participants', 'Forty participants completed the study']","['immediate implant placement and provisionalization with or without connective tissue graft', 'simultaneous CTG (test group) and not receive CTG', 'provisionalized implants with or without connective tissue graft (CTG']","['buccal tissue collapse', 'radiographic new bone formation', 'Mid-facial gingival margin migrations, soft tissue contour changes, and hard tissue remodeling']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",42.0,0.0425291,The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin.,"[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Di', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}]",Journal of clinical periodontology,['10.1111/jcpe.13331']
1772,32536019,"Vaginal compared with intramuscular progestogen for preventing preterm birth in high-risk pregnant women (VICTORIA study): a multicentre, open-label randomised trial and meta-analysis.","OBJECTIVE


To compare the efficacy of two types of progestogen therapy for preventing preterm birth (PTB) and to review the relevant literature.
DESIGN


A multicentre, randomised, open-label, equivalence trial and a meta-analysis.
SETTING


Tertiary referral hospitals in South Korea.
POPULATION


Pregnant women with a history of spontaneous PTB or short cervical length (<25 mm).
METHODS


Eligible women were screened and randomised at 16-22 weeks of gestation to receive either 200 mg of vaginal micronised progesterone daily (vaginal group) or an intramuscular injection of 250 mg 17α-hydroxyprogesterone caproate weekly (IM group). Stratified randomisation was carried out according to participating centres and indications for progestogen therapy. This trial was registered at ClinicalTrials.gov (NCT02304237).
MAIN OUTCOME MEASURE


Preterm birth (PTB) before 37 weeks of gestation.
RESULTS


A total of 266 women were randomly assigned and a total of 247 women (119 and 128 women in the vaginal and IM groups, respectively) were available for the intention-to-treat analysis. Risks of PTB before 37 weeks of gestation did not significantly differ between the two groups (22.7 versus 25.8%, P = 0.571). The difference in PTB risk between the two groups was 3.1% (95% CI -7.6 to 13.8%), which was within the equivalence margin of 15%. The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments.
CONCLUSION


Compared with vaginal progesterone, treatment with intramuscular progestin might increase the risk of PTB before 37 weeks of gestation by as much as 13.8%, or reduce the risk by as much as 7.6%, in women with a history of spontaneous PTB or with short cervical length.
TWEETABLE ABSTRACT


Vaginal and intramuscular progestogen showed equivalent efficacy for preventing preterm birth before 37 weeks of gestation.",2020,"The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments.
","['Setting Tertiary referral hospitals in South Korea', 'Population Pregnant women with history of spontaneous PTB or short cervical length (<25 mm', 'high-risk pregnant women', 'Eligible women', 'A total of 266 women were randomly assigned and a total of 247 (119 and 128 women in the vaginal and IM groups, respectively) were available for the intention-to-treat analysis']","['intramuscular progestin', '200 mg vaginal micronised progesterone daily (vaginal group) or intramuscular injection of 250 mg 17α-hydroxyprogesterone caproate', 'progestogen therapy', 'intramuscular progestogen']","['Risks of PTB', 'PTB risk', 'preterm birth', 'preterm birth (PTB', 'risk of PTB']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",266.0,0.445353,"The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments.
","[{'ForeName': 'S-J', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Kwak', 'Affiliation': 'Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kil', 'Affiliation': ""Yeouido St Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'S-C', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Pusan National University College of Medicine, Pusan, Korea.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Kwon', 'Affiliation': ""Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Chonnam National University Medical School, Gwangju, Korea.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Na', 'Affiliation': 'Kangwon National University Hospital, School of Medicine Kangwon National University, Chuncheon, Korea.'}, {'ForeName': 'J-G', 'Initials': 'JG', 'LastName': 'Bae', 'Affiliation': 'Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'H-H', 'Initials': 'HH', 'LastName': 'Cha', 'Affiliation': 'Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Shim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Oh', 'Affiliation': 'School of Medicine, Eulji University, Daejeon, Korea.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Cho', 'Affiliation': 'Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Cho', 'Affiliation': 'Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Jo', 'Affiliation': ""St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'G Y', 'Initials': 'GY', 'LastName': 'Choi', 'Affiliation': 'Soonchunhyang University Seoul Hospital, College of Medicine, Soonchunhyang University, Seoul, Korea.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Hur', 'Affiliation': 'Konyang University Hospital, Daejeon, Korea.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Hwang', 'Affiliation': 'Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'College of Medicine, Ewha Womans University, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16365']
1773,32548904,Evaluation of the Efficacy of Ultrapulsed CO 2  Laser in Chronic Wounds.,"BACKGROUND AND OBJECTIVES


Chronic wound repair is a major problem in wound treatment. Recently, several studies have suggested that carbon dioxide (CO 2  ) laser can be used to improve the healing of chronic wounds. The aim of the present study was to preliminarily investigate the efficacy of laser debridement in treating chronic wound through a comparison of traditional instrument/surgical debridement with the ultrapulsed CO 2  laser debridement in terms of wound healing, wound infection control, and wound blood perfusion.
STUDY DESIGN/MATERIALS AND METHODS


Patients with chronic wound admitted to the Wound Repair Clinic at The Affiliated Hospital of Southwest Medical University (Luzhou, China) between February 2019 and May 2019 were enrolled. They were randomly divided into two groups. The patients in one group were treated with traditional sharp instrument/surgical debridement (RT group; number of wounds: 28), while the patients in the other group were treated with ultrapulsed CO 2  laser debridement (LT group; number of wounds: 26). An intergroup comparison was performed based on parameters, such as wound healing, wound infection control, and changes in wound blood perfusion.
RESULTS


The wound healing rate and the total time to achieve healing were significantly better in the LT group versus the RT group at 7, 14, 21, and 28 days after treatment. The wound exudation scores were significantly higher in the LT group versus the RT group at 7, 14, and 28 days after treatment. The positive rate of pre-debridement bacterial culture was significantly lower in the LT group versus the RD group at 14 and 28 days after treatment. The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment.
CONCLUSION


For the treatment of chronic refractory wounds, the ultrapulsed CO 2  laser exhibits higher accuracy, more effectively controls wound infection, promotes an increase in wound blood perfusion, and achieves faster wound healing compared with traditional sharp instrument/surgical debridement. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,"The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment.
","['Patients with chronic wound admitted to the Wound Repair Clinic at The Affiliated Hospital of Southwest Medical University (Luzhou, China) between February 2019 and May 2019 were enrolled', 'Chronic Wounds']","['laser debridement', 'ultrapulsed CO 2  laser debridement', 'traditional sharp instrument/surgical debridement (RT', 'Ultrapulsed CO 2  Laser', 'carbon dioxide (CO 2  ) laser']","['wound healing, wound infection control, and changes in wound blood perfusion', 'wound exudation scores', 'wound healing, wound infection control, and wound blood perfusion', 'wound healing rate and the total time to achieve healing', 'positive rate of pre-debridement bacterial culture', 'wound healing', 'percentage of wound perfusion/normal periwound skin perfusion', 'wound blood perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0336668', 'cui_str': 'Sharp instrument'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",,0.0252332,"The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment.
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Danyu', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ruxi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}]",Lasers in surgery and medicine,['10.1002/lsm.23283']
1774,32545478,"Effects of Cocoa-Rich Chocolate on Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness in Postmenopausal Women: A Randomized Clinical Trial.","This study aimed to evaluate the effects of the intake of 10 g of cocoa-rich chocolate on blood pressure, other cardiovascular risk factors, and vascular structure and function in postmenopausal women. A total of 140 postmenopausal women participated in this randomized and controlled parallel clinical trial. For six months, the intervention group (IG;  n  = 73) consumed daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG;  n  = 67) did not receive any intervention. Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables were measured at baseline and six months. ANCOVA analyses adjusted for baseline values revealed no significant differences for systolic blood pressure (-1.45 mm Hg; 95% confidence interval (CI): -4.79, 1.88;  p  = 0.391) or baPWV (0.18 m/s; 95% CI: -0.14, 0.50;  p  = 0.263) between groups. A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02;  p  = 0.048). The rest of the vascular structure and function parameters and other measured variables remained unchanged. The daily intake of 10 g of cocoa-rich chocolate seems to provide little improvement to cardiovascular health, but neither does it cause any adverse effects on the parameters evaluated in postmenopausal women in the long term.",2020,"A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02;  p  = 0.048).","['Postmenopausal Women', 'postmenopausal women', '140 postmenopausal women']","['daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG;  n  = 67) did not receive any intervention', 'Cocoa-Rich Chocolate', 'cocoa-rich chocolate']","['Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness', 'baPWV', 'PP', 'systolic blood pressure', 'Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables', 'blood pressure, other cardiovascular risk factors, and vascular structure and function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",140.0,0.194294,"A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02;  p  = 0.048).","[{'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Garcia-Yu', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Agudo-Conde', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Gonzalez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernandez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}]",Nutrients,['10.3390/nu12061758']
1775,32545555,Differential Effects of Dietary Patterns on Advanced Glycation end Products: A Randomized Crossover Study.,"Dietary advanced glycation end products (AGEs) are believed to contribute to pathogenesis of diabetes and cardiovascular disease. The objective of this study was to determine if a diet high in red and processed meat and refined grains (HMD) would elevate plasma concentrations of protein-bound AGEs compared with an energy-matched diet high in whole grain, dairy, nuts and legumes (HWD). We conducted a randomized crossover trial with two 4-week weight-stable dietary interventions in 51 participants without type 2 diabetes (15 men and 36 women aged 35.1 ± 15.6 y; body mass index (BMI), 27.7 ± 6.9 kg/m 2 ). Plasma concentrations of protein-bound Nε-(carboxymethyl) lysine (CML), Nε-(1-carboxyethyl) lysine (CEL) and Nδ-(5-hydro-5-methyl-4-imidazolon-2-yl)-ornithine (MG-H1) were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The HMD significantly increased plasma concentrations (nmol/mL) of CEL (1.367, 0.78 vs. 1.096, 0.65;  p  < 0.01;  n  = 48) compared with the HWD. No differences in CML and MG-H1 between HMD and HWD were observed. HMD increased plasma CEL concentrations compared with HWD in individuals without type 2 diabetes.",2020,"The HMD significantly increased plasma concentrations (nmol/mL) of CEL (1.367, 0.78 vs. 1.096, 0.65;  p  < 0.01;  n  = 48) compared with the HWD.","['Advanced Glycation end Products', '51 participants without type 2 diabetes (15 men and 36 women aged 35.1 ± 15.6 y; body mass index (BMI), 27.7 ± 6.9 kg/m 2 ', 'individuals without type 2 diabetes']","['HMD', 'weight-stable dietary interventions', 'diet high in red and processed meat and refined grains (HMD', 'Nε-(carboxymethyl) lysine (CML), Nε-(1-carboxyethyl) lysine (CEL) and Nδ-(5-hydro-5-methyl-4-imidazolon-2-yl)-ornithine', 'Dietary advanced glycation end products (AGEs']","['plasma CEL concentrations', 'plasma concentrations']","[{'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0424657', 'cui_str': 'Weight steady'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0029277', 'cui_str': 'Ornithine'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0208736', 'cui_str': 'N(6)-(1-carboxyethyl)lysine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",51.0,0.0388324,"The HMD significantly increased plasma concentrations (nmol/mL) of CEL (1.367, 0.78 vs. 1.096, 0.65;  p  < 0.01;  n  = 48) compared with the HWD.","[{'ForeName': 'Yoona', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, Institute of Agriculture and Life Science, Gyeongsang National University, Jinju 52828, Korea.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Keogh', 'Affiliation': 'Health and Biomedical Innovation, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Permal', 'Initials': 'P', 'LastName': 'Deo', 'Affiliation': 'Health and Biomedical Innovation, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'Health and Biomedical Innovation, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}]",Nutrients,['10.3390/nu12061767']
1776,32552430,Differential changes in muscle architecture and neuromuscular fatigability induced by isometric resistance training at short and long muscle-tendon unit lengths.,"We evaluated the effects of differential muscle architectural adaptations on neuromuscular fatigue resistance. Seven young males and six females participated in this study. Using a longitudinal within-subject design, legs were randomly assigned to perform isometric training of the tibialis anterior (TA) three times per week for 8 wk at a short (S-group) or long muscle-tendon unit length (L-group). Before and following training, fascicle length (FL) and pennation angle (PA) of the TA were assessed. As well, fatigue-related time course changes in isometric maximal voluntary contraction (MVC) torque and isotonic peak power (20% MVC resistance) were determined before, immediately after, and 1, 2, 5, and 10 min following task failure. The fatiguing task consisted of repeated maximal effort isotonic (20% MVC resistance) contractions over a 40° range of motion until the participant reached a 40% reduction in peak power. Although there was no clear improvement in neuromuscular fatigue resistance following training in either group ( P  = 0.081; S-group: ∼20%; L-group: ∼51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (∼6%,  P  < 0.001) in the S-group ( r  = 0.739,  P  = 0.004) and negatively to the training-induced increase in FL (∼4%,  P  = 0.001) in the L-group ( r  = -0.568,  P  = 0.043). Both groups recovered similarly for MVC torque and peak power after the fatiguing task as compared with before training. We suggest that the relationships between the changes in muscle architecture and neuromuscular fatigue resistance depend on the muscle-tendon unit lengths at which the training is performed. NEW & NOTEWORTHY  Eight weeks of isometric training at a long or short muscle-tendon unit length increased and did not change fascicle length, respectively. The ""width"" of the torque-angle relationship plateau became broader following isometric training at the long length. Despite marked differences in muscle architecture and functional adaptations between the groups, there was only a small-magnitude improvement in neuromuscular fatigue resistance, which was surprisingly negatively related to increased fascicle length in the long length-training group.",2020,"Although there was no clear improvement of neuromuscular fatigue resistance following training in both groups (P = 0.081; S-Group: ~20%, L-Group: ~51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (~6%, P < 0.001) in the S-Group (r = 0.739, P = 0.004) and negatively to the training-induced increase in FL (~4%, P = 0.001) in the L-Group (r = -0.568, P = 0.043).",['Seven young males and 6 females participated in this study'],"['differential muscle architectural adaptations', 'isometric resistance training', 'isometric training of the tibialis anterior (TA', 'fatiguing task consisted of repeated maximal effort isotonic (20%MVC resistance) contractions']","['FL', 'PA', 'fascicle length (FL) and pennation angle (PA) of the TA', 'neuromuscular fatigue resistance', 'fatigue-related time-course changes in isometric maximal voluntary contraction (MVC) torque and isotonic peak power (20%MVC resistance', 'MVC torque and peak power']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",7.0,0.0211373,"Although there was no clear improvement of neuromuscular fatigue resistance following training in both groups (P = 0.081; S-Group: ~20%, L-Group: ~51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (~6%, P < 0.001) in the S-Group (r = 0.739, P = 0.004) and negatively to the training-induced increase in FL (~4%, P = 0.001) in the L-Group (r = -0.568, P = 0.043).","[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Akagi', 'Affiliation': 'College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Hinks', 'Affiliation': 'Department of Human Health and Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Power', 'Affiliation': 'Department of Human Health and Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00280.2020']
1777,32552433,"Inspiratory flow-resistive breathing, respiratory muscle-induced systemic oxidative stress, and diaphragm fatigue in healthy humans.","We questioned whether the respiratory muscles of humans contribute to systemic oxidative stress following inspiratory flow-resistive breathing, whether the amount of oxidative stress is influenced by the level of resistive load, and whether the amount of oxidative stress is related to the degree of diaphragm fatigue incurred. Eight young and healthy participants attended the laboratory for four visits on separate days. During the first visit, height, body mass, lung function, and maximal inspiratory mouth and transdiaphragmatic pressure (P dimax ) were assessed. During  visits 2-4 , participants undertook inspiratory flow-resistive breathing with either no resistance (control) or resistive loads equivalent to 50 and 70% of their P dimax  (P dimax 50% and P dimax 70%) for 30 min. Participants undertook one resistive load per visit, and the order in which they undertook the loads was randomized. Inspiratory muscle pressures were higher ( P  < 0.05) during the 5th and Final min of P dimax 50% and P dimax 70% compared with control. Plasma F 2 -isoprostanes increased ( P  < 0.05) following inspiratory flow-resistive breathing at P dimax 70%. There were no increases in plasma protein carbonyls or total antioxidant capacity. Furthermore, although we evidenced small reductions in transdiapragmaic twitch pressures (P diTW ) after inspiratory flow-resistive breathing at P dimax 50% and P dimax 70%, this was not related to the increase in plasma F 2 -isoprostanes. Our novel data suggest that it is only when sufficiently strenuous that inspiratory flow-resistive breathing in humans elicits systemic oxidative stress evidenced by elevated plasma F 2 -isoprostanes, and based on our data, this is not related to a reduction in P diTW . NEW & NOTEWORTHY  We examined whether the respiratory muscles of humans contribute to systemic oxidative stress following inspiratory flow-resistive breathing, whether the amount of oxidative stress is influenced by the level of resistive load, and whether the amount of oxidative stress is related to the degree of diaphragm fatigue incurred. It is only when sufficiently strenuous that inspiratory flow-resistive breathing elevates plasma F 2 -isoprostanes, and our novel data show that this is not related to a reduction in transdiaphragmatic twitch pressure.",2020,Plasma F 2 -isoprostanes increased (P < 0.05) following inspiratory flow resistive breathing at P dimax 70%.,"['Eight young and healthy participants attended the laboratory for 4 visits on separate days', 'healthy humans']","['Inspiratory flow resistive breathing, respiratory muscle', 'inspiratory flow resistive breathing']","['Plasma F 2 -isoprostanes', 'Inspiratory muscle pressures', 'plasma F 2 -isoprostanes', 'inspiratory flow resistive breathing with either no resistance (Control) or resistive loads equivalent', 'transdiapragmaic twitch pressures', 'plasma protein carbonyls and total antioxidant capacity', 'height, body mass, lung function and maximal inspiratory mouth and transdiaphragmatic pressure (P dimax ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0949860', 'cui_str': 'Isoprostane'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}]",8.0,0.0373658,Plasma F 2 -isoprostanes increased (P < 0.05) following inspiratory flow resistive breathing at P dimax 70%.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Briskey', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Vogel', 'Affiliation': 'Respiratory and Exercise Physiology Research Group, School of Health and Wellbeing, University of Southern Queensland, Ipswich, Queensland, Australia.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Exercise and Health Research Group, Sport, Health, and Performance Enhancement Research Centre, School of Science and Technology, Nottingham Trent University, Nottingham, Nottinghamshire, United Kingdom.'}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Sharpe', 'Affiliation': 'Exercise and Health Research Group, Sport, Health, and Performance Enhancement Research Centre, School of Science and Technology, Nottingham Trent University, Nottingham, Nottinghamshire, United Kingdom.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Dean E', 'Initials': 'DE', 'LastName': 'Mills', 'Affiliation': 'Respiratory and Exercise Physiology Research Group, School of Health and Wellbeing, University of Southern Queensland, Ipswich, Queensland, Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00091.2020']
1778,32552472,Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434.,"PURPOSE


The Children's Oncology Group (COG) protocol AALL0434 evaluated the safety and efficacy of multi-agent chemotherapy with Capizzi-based methotrexate/pegaspargase (C-MTX) in patients with newly diagnosed pediatric T-cell lymphoblastic lymphoma (T-LL) and gained preliminary data using nelarabine in high-risk patients.
PATIENTS AND METHODS


The trial enrolled 299 patients, age 1-31 years. High-risk (HR) patients had ≥ 1% minimal detectable disease (MDD) in the bone marrow at diagnosis or received prior steroid treatment. Induction failure was defined as failure to achieve a partial response (PR) by the end of the 4-week induction. All patients received the augmented Berlin-Frankfurt-Muenster (ABFM) C-MTX regimen. HR patients were randomly assigned to receive or not receive 6 5-day courses of nelarabine incorporated into ABFM. Patients with induction failure were nonrandomly assigned to ABFM C-MTX plus nelarabine. No patients received prophylactic cranial radiation; however, patients with CNS3 disease (CSF WBC ≥ 5/μL with blasts or cranial nerve palsies, brain/eye involvement, or hypothalamic syndrome) were ineligible.
RESULTS


At end-induction, 98.8% of evaluable participants had at least a PR. The 4-year event-free survival (EFS) and overall survival (OS) were 84.7% ± 2.3% and 89.0% ± 2.0%. The 4-year disease-free survival (DFS) from end-induction was 85.9% ± 2.6%. There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55). Disease stage, tumor response, and MDD at diagnosis did not demonstrate thresholds that resulted in differences in EFS. Nelarabine did not show an advantage for HR patients. CNS relapse occurred in only 4 patients.
CONCLUSION


COG AALL0434 produced excellent outcomes in one of the largest trials ever conducted for patients with newly diagnosed T-LL. The COG ABFM regimen with C-MTX provided excellent EFS and OS without cranial radiation.",2020,There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55).,"['patients with newly diagnosed pediatric T-cell lymphoblastic lymphoma (T-LL) and gained preliminary data using nelarabine in high-risk patients', '299 patients, age 1-31 years', 'patients with CNS3 disease (CSF WBC', 'Patients with induction failure', 'HR patients', 'patients with newly diagnosed T-LL', 'Newly Diagnosed T Lymphoblastic Lymphoma']","['nelarabine incorporated into ABFM', 'COG AALL0434', 'Nelarabine', 'augmented Berlin-Frankfurt-Muenster (ABFM) C-MTX regimen', 'prophylactic cranial radiation', 'multi-agent chemotherapy with Capizzi-based methotrexate/pegaspargase (C-MTX', 'ABFM C-MTX plus nelarabine']","['4-year disease-free survival (DFS', '4-year event-free survival (EFS) and overall survival (OS', 'DFS', '≥ 5/μL with blasts or cranial nerve palsies, brain/eye involvement, or hypothalamic syndrome', 'partial response (PR', 'Induction failure', 'CNS relapse', 'Disease stage, tumor response, and MDD at diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0855357', 'cui_str': 'CSF white blood cell count'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1292758', 'cui_str': 'Precursor T-cell lymphoblastic lymphoma'}]","[{'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0151311', 'cui_str': 'Cranial nerve paralysis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0442850', 'cui_str': 'Eye involvement'}, {'cui': 'C0751230', 'cui_str': 'Hypothalamic syndrome'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",299.0,0.0654142,There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55).,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hayashi', 'Affiliation': ""Pediatric Hematology/Oncology, Washington School of Medicine, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Stuart S', 'Initials': 'SS', 'LastName': 'Winter', 'Affiliation': ""Children's Minnesota Cancer and Blood Disorders Program, Minneapolis, MN.""}, {'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Dunsmore', 'Affiliation': 'Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, VA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': ""Laboratory Medicine, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Hermiston', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Teachey', 'Affiliation': ""Division of Oncology, Department of Pediatrics, Center for Childhood Cancer Research, Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Sherrie L', 'Initials': 'SL', 'LastName': 'Perkins', 'Affiliation': 'Department of Pathology, University of Utah Health Sciences Center, ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT.'}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': 'Department of Pathology, University of Utah Health Sciences Center, ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics and Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Pediatric Hematology/Oncology, University of Texas Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Division of Oncology, Department of Pediatrics, Center for Childhood Cancer Research, Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Lim', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, and The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': 'National Cancer Institute Center for Global Health, Rockville, MD.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""Division of Blood and Marrow Transplantation, Children's National Health System, Washington, DC.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00531']
1779,32556865,Machine learning-based development and validation of a scoring system for progression-free survival in liver cancer.,"OBJECT


Disease progression is an important factor affecting the long-term survival in hepatocellular carcinoma (HCC). The progression-free survival (PFS) has been used as a surrogate endpoint for overall survival (OS) in many solid tumors. However, there were few models to predict the PFS in HCC patients. This study aimed to explore the prognostic factors that affect the PFS in HCC and establish an individualized prediction model.
METHODS


We included 2890 patients with hepatitis B-related HCC hospitalized at Beijing Ditan Hospital, Capital Medical University and randomly divided into training and validation cohort. Cox multivariate regression was used to analyze independent risk factors affecting the 1-year PFS of HCC, and an artificial neural networks (ANNs) model was constructed. C-index, calibration curve, and decision curve analysis were used to evaluate the performance of the model.
RESULTS


The median survival time was 26.2 m (95% CI: 24.08-28.32) and the 1-year PFS rate was 52.3% in whole study population. Cox multivariate regression showed smoking history, tumor number ≥ 2, tumor size ≥ 5 cm, portal vein tumor thrombus, WBC, NLR, γ-GGT, ALP, and AFP ≥ 400 ng/mL were risk factors for 1-year progression-free survival, while albumin and CD4 T cell counts were protective factors in HCC patients. A prediction model for 1-year PFS was constructed ( https://lixuan.me/annmodel/myg-v3/ ). The ANNs model's ability to predict 1-year PFS had an area under the receiver operating characteristic curve (AUROC) of 0.866 (95% CI 0.848-0.884) in HCC patients, which was higher than predicted by TNM, BCLC, Okuda, CLIP, CUPI, JIS, and ALBI scores (p < 0.0001). In addition, the ANNs model could also estimate the probability of 1-year OS and presented a higher AUROC value, 0.877 (95% CI 0.858-0.895), than those other models. All patients were divided into high-, medium-, and low-risk groups, according to the ANNs model scores. Compared with the hazard ratios (HRs) of PFS and OS in low-risk group, those in the high-risk group were 26.42 (95% CI 18.74-37.25; p < 0.0001) and 11.26 (95% CI 9.11-13.93; p < 0.0001), respectively.
CONCLUSION


The ANNs model has good individualized prediction performance and may be helpful to evaluate the probability of progression-free survival in HCC during clinical practice.",2020,The ANNs model has good individualized prediction performance and may be helpful to evaluate the probability of progression-free survival in HCC during clinical practice.,"['hepatocellular carcinoma (HCC', '2890 patients with hepatitis B-related HCC hospitalized at Beijing Ditan Hospital, Capital Medical University and randomly divided into training and validation cohort', 'liver cancer']",[],"['smoking history, tumor number\u2009≥\u20092, tumor size\u2009≥\u20095\xa0cm, portal vein tumor thrombus, WBC, NLR, γ-GGT, ALP, and AFP', 'TNM, BCLC, Okuda, CLIP, CUPI, JIS, and ALBI scores', 'median survival time', '1-year PFS rate', 'hazard ratios (HRs) of PFS and OS', 'progression-free survival (PFS', 'probability of 1-year OS', 'risk factors for 1-year progression-free survival, while albumin and CD4 T cell counts']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}]",[],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C3163918', 'cui_str': 'Tumor thrombus'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",2890.0,0.0614393,The ANNs model has good individualized prediction performance and may be helpful to evaluate the probability of progression-free survival in HCC during clinical practice.,"[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Xianbo', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatobiliary Surgery,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China. movdush@139.com.'}, {'ForeName': 'Zhiyun', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China. yangzhiyun2016@163.com.'}]",Hepatology international,['10.1007/s12072-020-10046-w']
1780,32560181,"Effects of L-Phenylalanine on Energy Intake and Glycaemia-Impacts on Appetite Perceptions, Gastrointestinal Hormones and Gastric Emptying in Healthy Males.","In humans, phenylalanine stimulates plasma cholecystokinin (CCK) and pyloric pressures, both of which are important in the regulation of energy intake and gastric emptying. Gastric emptying is a key determinant of postprandial blood glucose. We evaluated the effects of intragastric phenylalanine on appetite perceptions and subsequent energy intake, and the glycaemic response to, and gastric emptying of, a mixed-nutrient drink. The study consisted of two parts, each including 16 healthy, lean males (age: 23 ± 1 years). In each part, participants received on three separate occasions, in randomised, double-blind fashion, 5 g (Phe-5 g) or 10g ('Phe-10 g) L-phenylalanine, or control, intragastrically, 30 min before a standardised buffet-meal (part A), or a standardised mixed-nutrient drink (part B). In part A, plasma CCK and peptide-YY (PYY), and appetite perceptions, were measured at baseline, after phenylalanine alone, and following the buffet-meal, from which energy intake was assessed. In part B, plasma glucose, glucagon-like peptide-1 (GLP-1), insulin and glucagon were measured at baseline, after phenylalanine alone, and for 2 h following the drink. Gastric emptying of the drink was also measured by  13 C-acetate breath-test. Phe-10 g, but not Phe-5 g, stimulated plasma CCK ( p  = 0.01) and suppressed energy intake ( p  = 0.012); energy intake was correlated with stimulation of CCK (r = -0.4,  p  = 0.027), and tended to be associated with stimulation of PYY (r = -0.31,  p  = 0.082). Both Phe-10 g and Phe-5 g stimulated insulin and glucagon (all  p  < 0.05), but not GLP-1. Phe-10 g, but not Phe-5 g, reduced overall plasma glucose ( p  = 0.043) and peak plasma glucose ( p  = 0.017) in response to the mixed-nutrient drink. Phenylalanine had no effect on gastric emptying of the drink. In conclusion, our observations indicate that the energy intake-suppressant effect of phenylalanine is related to the stimulation of CCK and PYY, while the glucoregulatory effect may be independent of stimulation of plasma GLP-1 or slowing of gastric emptying.",2020,"g, but not Phe-5 g, stimulated plasma CCK ( p  = 0.01) and suppressed energy intake ( p  = 0.012)","['16 healthy, lean males (age: 23 ± 1 years', 'Healthy Males']","['Phenylalanine', 'intragastric phenylalanine', 'L-phenylalanine, or control', 'L-Phenylalanine', 'phenylalanine']","['overall plasma glucose', 'appetite perceptions and subsequent energy intake', 'Energy Intake and Glycaemia-Impacts on Appetite Perceptions, Gastrointestinal Hormones and Gastric Emptying', 'plasma CCK and peptide-YY (PYY), and appetite perceptions', 'plasma cholecystokinin (CCK) and pyloric pressures', 'stimulated plasma CCK', 'Gastric emptying', 'peak plasma glucose', 'plasma glucose, glucagon-like peptide-1 (GLP-1), insulin and glucagon', 'suppressed energy intake', 'gastric emptying']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]",,0.0579056,"g, but not Phe-5 g, stimulated plasma CCK ( p  = 0.01) and suppressed energy intake ( p  = 0.012)","[{'ForeName': 'Penelope C E', 'Initials': 'PCE', 'LastName': 'Fitzgerald', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Manoliu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Herbillon', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Steinert', 'Affiliation': 'Department of Surgery, Division of Visceral and Transplantation Surgery, University Hospital Zürich, 8091 Zürich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}]",Nutrients,['10.3390/nu12061788']
1781,32560436,"The Impact of Protein Supplementation on Exercise-Induced Muscle Damage, Soreness and Fatigue Following Prolonged Walking Exercise in Vital Older Adults: A Randomized Double-Blind Placebo-Controlled Trial.","BACKGROUND


It is unknown whether protein supplementation can enhance recovery of exercise-induced muscle damage in older adults who have a disturbed muscle protein synthetic response. We assessed whether protein supplementation could attenuate exercise-induced muscle damage and soreness after prolonged moderate-intensity walking exercise in older adults.
METHODS


In a double-blind, placebo-controlled intervention study, 104 subjects (81% male, ≥65 years) used either a protein (n = 50) or placebo supplement (n = 54) during breakfast and directly after exercise. Within a walking event, study subjects walked 30/40/50 km per day on three consecutive days. Muscle soreness and fatigue were determined with a numeric rating scale, and creatine kinase (CK) concentrations and serum inflammation markers were obtained.
RESULTS


Habitual protein intake was comparable between the protein (0.92 ± 0.27 g/kg/d) and placebo group (0.97 ± 0.23 g/kg/d,  p  = 0.31). At baseline, comparable CK concentrations were found between the protein and the placebo group (110 (IQR: 84-160 U/L) and 115 (IQR: 91-186 U/L), respectively,  p  = 0.84). Prolonged walking (protein: 32 ± 9 km/d, placebo: 33 ± 6 km/d) resulted in a cumulative increase of CK in both the protein (∆283 (IQR: 182-662 U/L)) and placebo group (∆456 (IQR: 209-885 U/L)) after three days. CK elevations were not significantly different between groups ( p  = 0.43). Similarly, no differences in inflammation markers, muscle soreness and fatigue were found between groups.
CONCLUSIONS


Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.",2020,"CONCLUSIONS


Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.","['104 subjects (81% male, ≥65 years) used either a protein (n = 50) or', 'older adults', 'older adults who have a disturbed muscle protein synthetic response', 'Vital Older Adults']","['Protein supplementation', 'Placebo', 'protein supplementation', 'Prolonged Walking Exercise', 'Protein Supplementation', 'placebo supplement', 'placebo']","['CK elevations', 'CK concentrations', 'Muscle soreness and fatigue', 'cumulative increase of CK', 'numeric rating scale, and creatine kinase (CK) concentrations and serum inflammation markers', 'Habitual protein intake', 'Exercise-Induced Muscle Damage, Soreness and Fatigue', 'inflammation markers, muscle soreness and fatigue', 'muscle damage, muscle soreness or fatigue']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0442732', 'cui_str': 'Vital'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",104.0,0.447597,"CONCLUSIONS


Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.","[{'ForeName': 'Dominique S M', 'Initials': 'DSM', 'LastName': 'Ten Haaf', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Coen C W G', 'Initials': 'CCWG', 'LastName': 'Bongers', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Hugo G', 'Initials': 'HG', 'LastName': 'Hulshof', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}]",Nutrients,['10.3390/nu12061806']
1782,32561489,Rate and Predictors of Unanticipated Surgical Evacuation in Patients with Intracerebral Hemorrhage: Post Hoc Analysis of ATACH 2 Trial.,"BACKGROUND


We performed this analysis to identify the rates, predictors, and associated outcomes of unexpected neurosurgical evacuation in a multicenter randomized clinical trial, Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) 2.
METHODS


The ATACH 2 trial determined the efficacy of antihypertensive treatment in patients with spontaneous supratentorial intracerebral hemorrhages (ICHs) with a Glasgow Coma Scale (GCS) score of ≥5 and intraparenchymal hematoma volume of <60 cm 3  on initial computed tomographic scan. We determined the proportion of ICH patients requiring unanticipated surgical evacuation and identified baseline factors associated with evacuation.
RESULTS


Among the 992 subjects analyzed, 44 (4.4%) subjects required unanticipated surgical evacuation of hematoma. The proportion of subjects with initial GCS score of 13 or less was significantly higher among those who required surgical evacuation (43.2% vs. 26.8%, P < 0.001). In the logistics regression analysis, hematoma volume ≥18 cm 3  (odds ratio, 4.3; 95% confidence interval, 2.1-8.8) and right-sided hematoma (odds ratio, 2.8; 95% confidence interval, 1.3-5.9) were significantly associated with surgical evacuation. Age, location, GCS score strata, and allocated treatment (intensive vs. standard systolic blood pressure reduction) were not associated with surgical evacuation. Among the 44 patients who underwent surgical evacuation, death or disability at 3 months postrandomization was seen in 32 (73%) of 44 subjects.
CONCLUSIONS


In the large cohort of ATACH 2 subjects with good grade ICH, the rates of unanticipated surgical evacuation were low and were associated with relatively high rates of death or disability at 3 months.",2020,"In the logistics regression analysis, hematoma volume ≥ 18 cm 3  (odds ratio [OR], 4.3, 95% confidence interval [CI], 2.1-8.8) and right sided hematoma (OR, 2.8, 95% CI 1.3-5.9) were significantly associated with surgical intervention.","['44 patients who underwent', '992 subjects analyzed, 44 (4.4%) subjects required', 'patients with spontaneous supratentorial intracerebral hemorrhages (ICHs) with a Glasgow Coma Scale (GCS) score of ≥5 and intraparenchymal hematoma volume of < 60 cm3 on initial computed tomographic (CT) scan', 'Patients with Intracerebral Hemorrhage', 'Acute']",['antihypertensive treatment'],"['surgical evacuation, death or disability', 'rates of unanticipated surgical evacuation', 'Cerebral Hemorrhage', 'unanticipated surgical evacuation of hematoma', 'standard systolic blood pressure (SBP) reduction', 'right sided hematoma', 'proportion of subjects with initial GCS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0056610', 'cui_str': 'curium nitrate'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1261965', 'cui_str': 'Evacuation of hematoma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.104024,"In the logistics regression analysis, hematoma volume ≥ 18 cm 3  (odds ratio [OR], 4.3, 95% confidence interval [CI], 2.1-8.8) and right sided hematoma (OR, 2.8, 95% CI 1.3-5.9) were significantly associated with surgical intervention.","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute and Department of Neurology, University of Missouri-Columbia, Columbia, Missouri, USA.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Zeenat Qureshi Stroke Institute and Department of Neurology, University of Missouri-Columbia, Columbia, Missouri, USA. Electronic address: lobanovanmu@gmail.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Zeenat Qureshi Stroke Institute and Department of Neurology, University of Missouri-Columbia, Columbia, Missouri, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Neurosciences Critical Care, Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine Baltimore, Maryland, USA.'}]",World neurosurgery,['10.1016/j.wneu.2020.06.089']
1783,32562433,Effects of illness representation-focused patient education on illness representations and self-care in patients with heart failure: A randomised clinical trial.,"AIMS AND OBJECTIVES


To examine the effect of an illness representation-focused patient education intervention on illness representations and self-care behaviours in patients with heart failure 3 months after discharge from the hospital.
BACKGROUND


Few intervention studies have examined the effect of illness representation-focused interventions on illness representations and self-care in patients with heart failure.
DESIGN


A randomised clinical trial based on the Consolidated Standard of Reporting Trials-CONSORT 2010-guidelines was employed. The Clinical Trial Registry number is TCTR20190903002.
METHODS


One hundred and seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the usual care group) completed the baseline and one- and three-month postdischarge follow-up assessments. The instruments included the Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index. The intervention group received illness representation-focused patient education while hospitalised and telephone follow-ups after discharge. Data were analysed with linear mixed-effects model analysis.
RESULTS


The 107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03%. At baseline, the two groups tended to have accurate illness beliefs but insufficient self-care confidence and self-care maintenance. The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
CONCLUSION


The study did not show an effect of the intervention on illness representations or self-care maintenance behaviours. However, the intervention did maintain participants' self-care confidence three months after discharge.
RELEVANCE TO CLINICAL PRACTICE


It is necessary to conduct long-term follow-ups of patients' illness representations, discuss the implementation of self-care behaviours with patients, enhance patients' self-care confidence, and involve family members or caregivers in self-care practices when needed.",2020,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","['patients with heart failure three months after discharge from the hospital', '107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03', 'One hundred seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the', 'Patients with Heart Failure', 'patients with heart failure']","['illness representation-focused patient education intervention', 'Illness Representation-Focused Patient Education', 'illness representation-focused patient education while hospitalized and telephone follow-ups after discharge', 'usual care group) completed the baseline and one- and three-month post-discharge follow-up assessments']","['illness representations or self-care maintenance behaviours', 'illness representations and self-care behaviours', 'illness representation total scores, dimension scores or self-care maintenance scores', 'Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index', 'Illness Representations and Self-care', 'self-care confidence scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2733342', 'cui_str': 'Left ventricular ejection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C1320368', 'cui_str': 'Post-discharge follow-up'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",107.0,0.121429,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","[{'ForeName': 'Wan-Tzu', 'Initials': 'WT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Shan-Tair', 'Initials': 'ST', 'LastName': 'Wang', 'Affiliation': 'Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi City, Taiwan.'}, {'ForeName': 'Chi-Hsin', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Liang-Miin', 'Initials': 'LM', 'LastName': 'Tsai', 'Affiliation': 'Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hsing-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15384']
1784,32563171,Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy.,"PURPOSE


This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
METHODS


Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
RESULTS


During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
CONCLUSION


In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.",2020,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","['and myoclonic and absence seizures', 'patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332', 'Patients experiencing myoclonic and/or absence seizures during study baseline were included', 'patients with idiopathic generalized epilepsy', 'IGE patients with myoclonic and/or absence seizures']","['Adjunctive perampanel', 'adjunctive perampanel', 'placebo']","['responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs', 'seizure frequency', 'overall worsening of absence seizures', 'myoclonic and/or absence seizures', 'seizure frequency, number of seizure days and seizure-free days', 'seizure-freedom rates', 'myoclonic and absence seizure outcomes']","[{'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.383148,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.'}]",Seizure,['10.1016/j.seizure.2020.06.011']
1785,32540588,Deep transcranial magnetic stimulation for obsessive-compulsive disorder is efficacious even in patients who failed multiple medications and CBT.,"OCD is a chronic and disabling disease with a lifetime prevalence of 2%-3%. About 40-60% of these patients do not adequately respond to pharmacotherapy and CBT. Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals. Yet it is unclear whether patients who failed numerous medications and/or CBT can still benefit from dTMS. Here, we analyzed recent data from a double-blind multicenter dTMS study and found efficacy of this novel treatment even in OCD patient cohorts who previously failed to respond to multiple medications and CBT.",2020,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"['OCD patient cohorts who previously failed to respond to multiple medications and CBT', 'patients who failed multiple medications and CBT']","['OCD', 'Deep transcranial magnetic stimulation', 'Deep transcranial magnetic stimulation (dTMS']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0274375,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"[{'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Roth', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, TX, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Tendler', 'Affiliation': 'Advanced Mental Health Care, Inc., Palm Beach, FL, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2020.113179']
1786,32540624,Effects of night-time bicycling visibility aids on vehicle passing distance.,"Bicycling at night is dangerous, with vehicle passing distances being a key concern, given that the main cause of night-time bicycling fatalities is from motorists hitting bicyclists from behind. However, little is known about vehicle passing distances at night or how they are affected by bicyclist visibility. This study assessed the impact of different bicyclist visibility configurations on vehicle passing distances at night-time. Fourteen licenced drivers with normal vision (age 24.2 ± 3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night. Each lap involved passing two bicyclists displaying one of four visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles). Participants were instructed to pass each bicyclist at a distance of 1-metre at a speed no greater than 50 km/hr, consistent with Queensland's Minimum Passing Distance rule. Participants completed eight laps, two for each configuration, in a randomised sequence. Passing distance was measured using a vehicle-mounted ultra-sonic sensor (ToughSonic14; Senix). Following each lap, participants rated the difficulty level in judging the 1-metre passing distance, as well as their estimated passing distance. Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other. There was also a significant effect of visibility configuration on difficulty rating (p = 0.035), with the Control rated as the most difficult, followed by Helmet, Handlebars and Leg Retro-reflectors. Overall, additional visibility aids resulted in wider vehicle passing distances, likely due to enhanced visual cues for drivers. The findings suggest that bicyclists should incorporate additional visibility aids to encourage safer passing distances of vehicles at night-time.",2020,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.",['Fourteen licenced drivers with normal vision (age 24.2\u202f±\u202f3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night'],"['visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles', 'night-time bicycling visibility aids']","['visibility configuration on difficulty rating', 'Leg Retro-reflectors']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.0635457,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.","[{'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Black', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia. Electronic address: aa.black@qut.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Duff', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ng', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Ussher', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wood', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105636']
1787,32543706,Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients.,"Bone morphogenetic proteins (BMPs) are potent osteogenic proteins that induce new bone formation in vivo. However, their effect on bone healing in the trabecular bone surfaces remains challenging. We evaluated the safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) in a surgically created wedge defect of the proximal tibia in patients undergoing high tibial osteotomy (HTO) for varus deformity and medial osteoarthritis of the knee. We enrolled 20 HTO patients in a randomized, placebo-controlled, double-blinded phase I/II clinical trial. RhBMP6/ABC (1.0 mg/10 mL ABC prepared from peripheral blood) or placebo (10 mL ABC containing excipients) was administered into the tibial wedge defects. Patients were followed for 0 to 24 months by clinical examination (safety) and computed tomography (CT) and serial radiographic analyses (efficacy). The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks after implantation. During the 24 months of follow-up, there were no serious adverse reactions recorded. The CT scans from defects of patients treated with rhBMP6/ABC showed an accelerated bone healing compared with placebo at 9 weeks (47.8 ± 24.1 versus 22.2 ± 12.3 mg/cm 3  ; p = 0.008) and at 14 weeks (89.7 ± 29.1 versus 53.6 ± 21.9 mg/cm 3  ; p = 0.006) follow-up. Radiographic analyses at weeks 6 and 24 and months 12 and 24 suggested the advanced bone formation and remodeling in rhBMP6/ABC-treated patients. In conclusion, we show that rhBMP6/ABC at a dose of 100 μg/mL accelerated bone healing in patients undergoing HTO without serious adverse events and with a good tolerability compared with placebo alone. Overall, for the first time, a BMP-based osteogenic implant was examined against a placebo for bone healing efficacy in the trabecular bone surface, using an objective bone mineral density measurement system. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"['High Tibial Osteotomy patients', 'patients undergoing high tibial osteotomy (HTO) for Varus deformity and medial osteoarthritis of the knee', '20 HTO patients']","['Recombinant human BMP6', 'RhBMP6/ABC ', 'rhBMP6/ABC', 'recombinant human BMP6 (rhBMP6', 'placebo']","['accelerated bone healing', 'clinical examination (safety) and CT and serial radiographic analyses (efficacy', 'bone healing', 'detectable anti-rhBMP6 antibodies', 'advanced bone formation and remodelling']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0302148', 'cui_str': 'Blood clot'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",20.0,0.154535,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"[{'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Chiari', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Grgurevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Bordukalo-Niksic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Oppermann', 'Affiliation': 'Genera Research, Rakov Potok, Croatia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valentinitsch', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nemecek', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Staats', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schreiner', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Trost', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolb', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Pehar', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Department of Environmental and Occupational Health and Sports, School of Public Health, ""Andrija Stampar,"", University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Snjezana', 'Initials': 'S', 'LastName': 'Martinovic', 'Affiliation': 'SmartMedico, Zagreb, Croatia.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department for Intracellular Communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'T Kuber', 'Initials': 'TK', 'LastName': 'Sampath', 'Affiliation': 'perForm Biologics Inc., Holliston, MA, USA.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Vukicevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4107']
1788,32544572,"A 10-week yoga practice has no effect on cognition, but improves balance and motor learning by attenuating brain-derived neurotrophic factor levels in older adults.","Despite studies investigating the effect of yoga on cognitive and motor functioning in older adults, the effect on dual-task performance and motor learning and the specific mechanisms underlying the positive effect of yoga remain unclear. Thus, the aim of this study was to investigate the effects of yoga on cognition, balance under single- and dual-task conditions, and motor learning. The potential role of brain-derived neurotrophic factor (BDNF) in induced improvement was also explored. Participants aged 60-79 years were randomized to either a control group (n = 15) or a yoga group (n = 18) for a 10-week period. The yoga group received 90-min duration yoga classes two times per week. Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements were assessed. Yoga practice decreased (P < 0.05) the velocity vector of the center of pressure under single- and dual-task conditions, whereas no changes in cognitive performance were observed. Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group. Significant moderate relationships (P < 0.05) between changes in BDNF levels and functional improvements were observed. Thus, 10 weeks of yoga practice resulted in improved balance and learning in the speed-accuracy motor task that were mediated by increased BDNF levels, but had no impact on cognition in older adults.",2020,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","['Participants aged 60-79\u202fyears', 'older adults']","['brain-derived neurotrophic factor (BDNF', 'control group (n\u202f=\u202f15) or a yoga group']","['cognitive performance', 'Yoga practice', 'BDNF levels', 'shorter movement time', 'reaction and movement times during learning', 'velocity vector of the center of pressure under single- and dual-task conditions', 'Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements', 'balance and learning', 'cognition, balance under single- and dual-task conditions, and motor learning', 'BDNF levels and functional improvements', 'faster reaction time']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0174528,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","[{'ForeName': 'Agnė', 'Initials': 'A', 'LastName': 'Čekanauskaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania. Electronic address: agne.cekanauskaite@lsu.lt.'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kilikevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}]",Experimental gerontology,['10.1016/j.exger.2020.110998']
1789,32544700,Time course of drug-related treatment-emergent adverse side effects of brivaracetam.,"OBJECTIVE


Treatment-emergent adverse events (TEAEs) in clinical trials are typically reported for the full duration of the treatment period including titration and maintenance. Drug-related central nervous system (CNS) TEAEs are common with antiseizure medications (ASMs) and can affect drug tolerability. In this report, we test the hypothesis that drug-related CNS TEAEs have early onset and decrease with time. Unlike prior ASM clinical trials, a novel design was used for brivaracetam (BRV) without initial drug titration allowing assessment of habituation to TEAEs separate from dose titration.
METHODS


Data were pooled from three studies (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]) in adult patients (≥16 years of age) with focal seizures receiving BRV adjunctive therapy. This post hoc analysis reports data on the prevalence and incidence of all drug-related CNS TEAEs and all TEAEs over time in patients who received BRV doses of 50-200 mg/day (without titration) vs. placebo during a 12-week treatment period.
RESULTS


A total of 1262 patients received the following: placebo (n = 459), BRV 50 mg/day (n = 200), BRV 100 mg/day (n = 353), and BRV 200 mg/day (n = 250). Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
CONCLUSIONS


Drug-related CNS TEAEs occurred early and substantially habituated over several weeks. TEAEs of ASMs might be better represented by division into early and late phases to guide clinician monitoring and patient expectations.",2020,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","['1262 patients', 'adult patients (≥16\u202fyears of age) with focal seizures receiving BRV adjunctive therapy']","['Drug-related central nervous system (CNS', 'brivaracetam', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],1262.0,0.10034,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","[{'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium. Electronic address: cedric.laloyaux@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: teresa.gasalla@ucb.com.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Fishman', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: jfishman@its.jnj.com.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: melinda.martin@ucb.com.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA. Electronic address: kleinp@epilepsydc.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107212']
1790,32544794,Acute aerobic exercise enhances pleasant compared to unpleasant visual scene processing.,"Although acute aerobic exercise benefits different aspects of emotional functioning, it is unclear how exercise influences the processing of emotional stimuli and which brain mechanisms support this relationship. We assessed the influence of acute aerobic exercise on valence biases (preferential processing of negative/positive pictures) by performing source reconstructions of participants' brain activity after they viewed emotional scenes. Twenty-four healthy participants (12 women) were tested in a randomized and counterbalanced design that consisted of three experimental protocols, each lasting 30 min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST). After each of the protocols, participants viewed negative and positive pictures, during which event-related magnetic fields were recorded. Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset. Brain activity in this cluster showed that a negativity bias at REST (negative > positive picture processing) diminished after the Low-Int condition (positive = negative) and even reversed to a positivity bias after the Mod-Int condition (positive > negative). Thus, acute aerobic exercise of low and moderate intensities induces a positivity bias which is reflected in early, automatic processes.",2020,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"['Twenty-four healthy participants (12 women', ""participants' brain activity after they viewed emotional scenes""]","['Acute aerobic exercise enhances pleasant', 'lasting 30\xa0min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST', 'acute aerobic exercise']","['valence processing of emotional scenes', 'Brain activity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",24.0,0.139816,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"[{'ForeName': 'Tomasz S', 'Initials': 'TS', 'LastName': 'Ligeza', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland. Electronic address: tomasz.ligeza@uj.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Wyczesany', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Institute for Sports Science, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Roesmann', 'Affiliation': 'Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany; Institute for Clinical Psychology, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Junghofer', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}]",Brain and cognition,['10.1016/j.bandc.2020.105595']
1791,32549135,Double-blind trial of solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE) for osteoarthritis of knee.,"Objectives The present study was planned to investigate the efficacy of SLBSP vs. standardized BSE for symptomatic knee osteoarthritis (OA) treatment. Methods It was a prospective, randomized, double-blind, double-dummy, placebo-controlled, and single-centre clinical trial for symptomatic osteoarthritis of knee. Subjects were randomized to receive SLBSP capsule+BSE Placebo or BSE tablet+SLBSP placebo for two months. Patients were allowed to take rescue analgesics (Acelofenac 100 mg). Improvement in pain and function was assessed utilizing WOMAC, VAS. Level of CTX-II in urine and serum levels of inflammatory cytokines including IL-2, IL-4, IL-6, TNF-α, and IFN-γ was measured initially and at end of treatment. Results and conclusions Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and Visual Analog Scale score improved markedly in SLBSP as well as in BSE arm (p < 0.05). Difference in VAS and WOMAC scores between the two arms was not statistically significant. Most significant effect was observed in the need for rescue analgesics. SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05). Both groups showed marked improvement in pain, SLBSP being superior to BSE with respect to reducing the need for rescue analgesics in addition to modulating inflammatory cytokines.",2020,SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05).,"['symptomatic knee osteoarthritis (OA) treatment', 'osteoarthritis of knee', 'symptomatic osteoarthritis of knee']","['solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE', 'SLBSP capsule\xa0+\xa0BSE Placebo or BSE tablet\xa0+\xa0SLBSP placebo', 'SLBSP', 'SLBSP vs. standardized BSE', 'placebo']","['WOMAC and VAS score', 'pain and function', 'VAS and WOMAC scores', 'Level of CTX-II in urine and serum levels of inflammatory cytokines including IL-2, IL-4, IL-6, TNF-α, and IFN-γ', 'pain, SLBSP', 'lowering of pro-inflammatory cytokines levels']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0873038', 'cui_str': 'boswellia preparation'}, {'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",,0.428873,SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05).,"[{'ForeName': 'Preeti D', 'Initials': 'PD', 'LastName': 'Kulkarni', 'Affiliation': 'School of Pharmacy and Medical Science, Singhania University, Pacheri Bari, Jhunjhunu, 333515,Rajasthan, India.'}, {'ForeName': 'Neena D', 'Initials': 'ND', 'LastName': 'Damle', 'Affiliation': 'Department of Kaya Chikitsa, DY Patil University, School of Ayurveda, Navi Mumbai, India.'}, {'ForeName': 'Sumer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'School of Life Sciences, Singhania University, Jhunjhunu, Rajasthan, India.'}, {'ForeName': 'Krishnat S', 'Initials': 'KS', 'LastName': 'Yadav', 'Affiliation': 'Department of Biochemistry, Padmashree Dr. D Y Patil Medical College and Hospital, Navi Mumbai, India.'}, {'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Ghante', 'Affiliation': 'Sinhgad Technical Education Society, Smt. Kashibai Navale College of Pharmacy [Kondhwa], S. P. Pune University, Pune, India.'}, {'ForeName': 'Vaidhun H', 'Initials': 'VH', 'LastName': 'Bhaskar', 'Affiliation': 'Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, India.'}, {'ForeName': 'Lal', 'Initials': 'L', 'LastName': 'Hingorani', 'Affiliation': 'Pharmanza Herbal Pvt. Ltd., Dharmaj, Gujarat, India.'}, {'ForeName': 'Vikram S', 'Initials': 'VS', 'LastName': 'Gota', 'Affiliation': 'Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi-Mumbai, India.'}]",Drug metabolism and personalized therapy,['10.1515/dmpt-2020-0104']
1792,32558226,Use of a Bluetooth tablet-based technology to improve outcomes in lung transplantation: A pilot study.,"The impact of remote patient monitoring platforms to support the postoperative care of solid organ transplant recipients is evolving. In an observational pilot study, 28 lung transplant recipients were enrolled in a novel postdischarge home monitoring program and compared to 28 matched controls during a 2-year period. Primary endpoints included hospital readmissions and total days readmitted. Secondary endpoints were survival and inflation-adjusted hospital readmission charges. In univariate analyses, monitoring was associated with reduced readmissions (incidence rate ratio [IRR]: 0.56; 95% confidence interval [CI]: 0.41-0.76; P < .001), days readmitted (IRR: 0.46; 95% CI: 0.42-0.51; P < .001), and hospital charges (IRR: 0.52; 95% CI: 0.51-0.54; P < .001). Multivariate analyses also showed that remote monitoring was associated with lower incidence of readmission (IRR: 0.38; 95% CI: 0.23-0.63; P < .001), days readmitted (IRR: 0.14; 95% CI: 0.05-0.37; P < .001), and readmission charges (IRR: 0.11; 95% CI: 0.03-0.46; P = .002). There were 2 deaths among monitored patients compared to 6 for controls; however, this difference was not significant. This pilot study in lung transplant recipients suggests that supplementing postdischarge care with remote monitoring may be useful in preventing readmissions, reducing subsequent inpatient days, and controlling hospital charges. A multicenter, randomized control trial should be conducted to validate these findings.",2020,"In univariate analyses, monitoring was associated with reduced readmissions (IRR: 0.56; 95% CI: 0.41 - 0.76; p < 0.001), days readmitted (IRR: 0.46; 95% CI: 0.42 - 0.51; p < 0.001), and hospital charges (IRR: 0.52; 95% CI: 0.51 - 0.54; p < 0.001).","['lung transplant recipients', '28 lung transplant recipients were enrolled in a novel post-discharge home monitoring program and compared to 28 matched controls during a two-year period', 'lung transplantation']",['Bluetooth tablet-based technology'],"['hospital charges', 'survival and inflation-adjusted hospital readmission charges', 'incidence of readmission', 'hospital readmissions and total days readmitted', 'readmission charges']","[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0206175', 'cui_str': 'Charge, Hospital'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0472527,"In univariate analyses, monitoring was associated with reduced readmissions (IRR: 0.56; 95% CI: 0.41 - 0.76; p < 0.001), days readmitted (IRR: 0.46; 95% CI: 0.42 - 0.51; p < 0.001), and hospital charges (IRR: 0.52; 95% CI: 0.51 - 0.54; p < 0.001).","[{'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Schenkel', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Barr', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'McCloskey', 'Affiliation': 'ActiCare Health, Livermore, California, USA.'}, {'ForeName': 'Tammie', 'Initials': 'T', 'LastName': 'Possemato', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': ""O'Conner"", 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Sadeghi', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bembi', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Duong', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jaynita', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Hackmann', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Sivagini', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Southern California, Los Angeles, California, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16154']
1793,32558989,"Effects of danicamtiv, a novel cardiac myosin activator, in heart failure with reduced ejection fraction: experimental data and clinical results from a phase 2a trial.","AIMS


Both left ventricular (LV) and left atrial (LA) dysfunction and remodelling contribute to adverse outcomes in heart failure with reduced ejection fraction (HFrEF). Danicamtiv is a novel, cardiac myosin activator that enhances cardiomyocyte contraction.
METHODS AND RESULTS


We studied the effects of danicamtiv on LV and LA function in non-clinical studies (ex vivo: skinned muscle fibres and myofibrils; in vivo: dogs with heart failure) and in a randomized, double-blind, single- and multiple-dose phase 2a trial in patients with stable HFrEF (placebo, n = 10; danicamtiv, n = 30; 50-100 mg twice daily for 7 days). Danicamtiv increased ATPase activity and calcium sensitivity in LV and LA myofibrils/muscle fibres. In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL, P < 0.05) and LA emptying fraction (+10.7%, P < 0.05). In patients with HFrEF (mean age 60 years, 25% women, ischaemic heart disease 48%, mean LV ejection fraction 32%), treatment-emergent adverse events, mostly mild, were reported in 17 patients (57%) receiving danicamtiv and 4 patients (40%) receiving placebo. Danicamtiv (at plasma concentrations ≥2000 ng/mL) increased stroke volume (up to +7.8 mL, P < 0.01), improved global longitudinal (up to -1.0%, P < 0.05) and circumferential strain (up to -3.3%, P < 0.01), decreased LA minimal volume index (up to -2.4 mL/m 2  , P < 0.01) and increased LA function index (up to 6.1, P < 0.01), when compared with placebo.
CONCLUSIONS


Danicamtiv was well tolerated and improved LV systolic function in patients with HFrEF. A marked improvement in LA volume and function was also observed in patients with HFrEF, consistent with pre-clinical findings of direct activation of LA contractility.",2020,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","['heart failure with reduced ejection fraction', 'heart failure with reduced ejection fraction (HFrEF', 'vivo: dogs with heart failure', 'patients with stable', 'patients with HFrEF']","['danicamtiv, a novel cardiac myosin activator', 'HFrEF (placebo', 'placebo']","['circumferential strain', 'LA function index', 'LA volume and function', 'stroke volume', 'tolerated and improved LV systolic function', 'LV and LA function', 'LA minimal volume index', 'LA emptying fraction', 'LV stroke volume', 'global longitudinal', 'ATPase activity and calcium sensitivity']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949656', 'cui_str': 'Cardiac Myosin'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001473', 'cui_str': 'Adenosinetriphosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.144767,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tamby', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, Jacksonville, FL, USA.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Forgosh', 'Affiliation': 'HealthEast Heart Care, Saint Paul, MN, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Tennova Healthcare-Harton, Tullahoma, TN, USA.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Camacho', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Karra', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Henk P', 'Initials': 'HP', 'LastName': 'Swart', 'Affiliation': 'Antonius Ziekenhuis Sneek, Sneek, The Netherlands.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organization, Berlin, Germany.'}, {'ForeName': 'Ray E', 'Initials': 'RE', 'LastName': 'Hershberger', 'Affiliation': 'Divisions of Human Genetics and Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ""Cardiovascular Imaging Core Laboratory, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Anto', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kaylyn', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Henze', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kurio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Teichman', 'Affiliation': 'Teichman Drug Development Consulting, Oakland, CA, USA.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Del Rio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1933']
1794,32559025,Strengthening effect of bioceramic cement when used to repair simulated internal resorption cavities in endodontically treated teeth.,"BACKGROUND


The reinforcement of teeth with internal root resorption is essential to prevent their fracture.
OBJECTIVES


The aim of this study was to assess the fracture resistance of the premolar teeth with internal root resorption cavities (IRCs), repaired with glass-ionomer cement (GIC), gutta-percha (GP) or EndoSequence® Root Repair MaterialTM (RRM).
MATERIAL AND METHODS


Forty lower premolars, instrumented to size 50, were used. Ten teeth were assigned to the control group, which received the full obturation of the root canals. In the remaining 30, IRCs were prepared with Gates-Glidden burs. The apical 8 mm was obturated to the level of IRC using the single-cone technique. Then, the teeth were divided into 3 groups according to the material used for repairing the cavities (n = 10): GIC; GP; and RRM. The canals were filled with respective materials and backfilled with GP. All of the specimens were scanned at the level of IRC with a micro-computed tomography (micro-CT) system, and the volume of the IRCs and the percentages of voids in the filling materials were measured. The specimens were subjected to fracture testing. The force recorded at the time of fracture was analyzed with the Kruskal-Wallis test and the independent t-test.
RESULTS


The control group showed a significantly higher mean value of fracture resistance as compared to the groups with IRCs (p < 0.05). No significant difference was found between GIC and RRM, whereas the GP group had a significantly lower fracture resistance than other tested IRC groups (p < 0.05). The percentage of voids was significantly higher in the GIC group as compared to the GP and RRM groups (p < 0.05).
CONCLUSIONS


EndoSequence Root Repair Material provides more strength to the teeth than the GP/sealer technique when both are used to fill a resorption cavity. The fracture resistance of the teeth filled with RRM was close to that obtained with GIC.",2020,"No significant difference was found between GIC and RRM, whereas the GP group had a significantly lower fracture resistance than other tested IRC groups (p < 0.05).","['Forty lower premolars, instrumented to size 50, were used', 'endodontically treated teeth']","['bioceramic cement', 'internal root resorption cavities (IRCs), repaired with glass-ionomer cement (GIC), gutta-percha (GP) or EndoSequence® Root Repair MaterialTM (RRM']","['percentage of voids', 'fracture resistance', 'mean value of fracture resistance', 'GIC and RRM']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0376699', 'cui_str': 'Tooth, Endodontically-Treated'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",10.0,0.0179111,"No significant difference was found between GIC and RRM, whereas the GP group had a significantly lower fracture resistance than other tested IRC groups (p < 0.05).","[{'ForeName': 'Wafaa Abdelbaky', 'Initials': 'WA', 'LastName': 'Khalil', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alghamdi', 'Affiliation': 'Department of Oral Biology, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Esraa', 'Initials': 'E', 'LastName': 'Aljahdali', 'Affiliation': 'Intern, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",Dental and medical problems,['10.17219/dmp/116743']
1795,32553835,Reductions in Parent Interest in Receiving Antibiotics Following a 90-Second Video Intervention in Outpatient Pediatric Clinics.,"OBJECTIVES


To assess the impact of a 90-second animated video on parents' interest in receiving an antibiotic for their child.
STUDY DESIGN


This pre-post test study enrolled English and Spanish speaking parents (n=1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms. Before meeting with their provider, parents rated their interest in receiving an antibiotic for their child, answered six true/false antibiotic knowledge questions, viewed the video, and then rated their antibiotic interest again. Parents rated their interest in receiving an antibiotic using a visual analogue scale ranging from 0-100, with 0 being ""I definitely do not want an antibiotic,"" 50 ""Neutral,"" and 100 ""I absolutely want an antibiotic.""
RESULTS


Parents were 84% female, mean age 32 (SD=6.0), 26.0% had a high school education or less, 15% Black, and 19% Hispanic. After watching the video, parents' average antibiotic interest ratings dropped 10 points (M=57.0, SD=20 to M=47.5, SD=21; P < .0001). Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
CONCLUSIONS


A 90-second video can reduce parents' interest in receiving antibiotics, especially among those with higher baseline interest. This scalable intervention could be used in a variety of settings to reduce parents' interest in receiving antibiotics.",2020,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","['This pre-post test study enrolled English and Spanish speaking parents (n=1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms', 'Parents were 84% female, mean age 32 (SD=6.0), 26.0% had a high school education or less, 15% Black, and 19% Hispanic', ""parents' interest in receiving an antibiotic for their child"", 'Outpatient Pediatric Clinics']",['90-second animated video'],[],"[{'cui': 'C0032919', 'cui_str': 'Pre-Post Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",[],,0.0489348,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City; University of Missouri - Kansas City School of Medicine, Kansas City; University of Missouri - Kansas City School of Pharmacy, Kansas City. Electronic address: kgoggin@cmh.edu.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Bickford', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lee', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City; University of Missouri - Kansas City School of Medicine, Kansas City.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Pina', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Evelyn Donis', 'Initials': 'ED', 'LastName': 'De Miranda', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mackenzie', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Sunflower Medical Group, Kansas City.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Weltmer', 'Affiliation': 'University of Missouri - Kansas City School of Medicine, Kansas City.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, Santa Monica.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City; Emergency Department, Children's Mercy, Kansas City.""}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Newland', 'Affiliation': ""Pediatric Infectious Disease, St. Louis Children's Hospital, St. Louis.""}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Myers', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City; Pediatric Infectious Diseases, Children's Mercy, Kansas City.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.027']
1796,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE


To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds.
RESULTS


In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures.
CONCLUSIONS


This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113']
1797,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).
CONCLUSIONS


As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008']
1798,32568196,"Safety, Tolerability, and Pharmacokinetics of Crenezumab in Patients with Mild-to-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133 Weeks.","BACKGROUND


Crenezumab is a fully humanized, monoclonal anti-amyloid-β immunoglobulin G4 antibody.
OBJECTIVE


This Phase Ib study (NCT02353598) evaluated the safety, tolerability, and pharmacokinetics of crenezumabat doses of ≤120 mg/kg administered intravenously every 4 weeks (q4w). Immunogenicity and exploratory biomarkers were also evaluated.
METHODS


In this multicenter, double-blind study, participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive positron emission tomography (PET) scan were randomized to receive crenezumab 30 or 45 mg/kg (Cohort 1, n = 21), 60 mg/kg (Cohort 2, n = 21), or 120 mg/kg (Cohort 3, n = 19) or corresponding placebo (n = 14) intravenously q4w for 13 weeks. Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received crenezumab at the originally assigned dose level, except for Cohort 3 (crenezumab 60 mg/kg during OLE). Participants received regular brain MRIs to assess amyloid-related imaging abnormalities (ARIA). Results up to Week 133 are reported.
RESULTS


Approximately 94% of participants experienced ≥1 adverse event (AE). Most AEs were mild or moderate; 15.5% experienced a Grade ≥3 AE. No ARIA-edema/effusion (ARIA-E) events were observed. New ARIA-micro hemorrhages and hemosiderosis (ARIA-H) were reported in 4.9% (double-blind treatment period) and 9.9% (combined double-blind treatment and OLE periods) of participants. Steady-state trough concentrations of crenezumab were dose-proportional and maintained for each dose level.
CONCLUSION


Crenezumab doses of ≤120 mg/kg intravenously q4w were well tolerated. The observed safety profile for ≤133 weeks of treatment in a mild-to-moderate AD population was similar to that seen in previous trials.",2020,No ARIA-edema/effusion (ARIA-E) events were observed.,"[""Patients with Mild-To-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133\xa0Weeks"", ""participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive PET scan"", 'Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received']","['regular brain MRIs', 'crenezumab', 'placebo']","['xSafety, Tolerability, and Pharmacokinetics of Crenezumab', 'New ARIA-micro hemorrhages and hemosiderosis (ARIA-H', 'tolerated', '≥1 adverse event (AE', 'safety, tolerability, and pharmacokinetics', 'Immunogenicity and exploratory biomarkers', 'No ARIA-edema/effusion (ARIA-E) events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3495884', 'cui_str': 'Amyloid related imaging abnormalities'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019114', 'cui_str': 'Hemosiderosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3267084', 'cui_str': 'Amyloid related imaging abnormality-oedema/effusion'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",71.0,0.439878,No ARIA-edema/effusion (ARIA-E) events were observed.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Honig', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Blondeau', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Quartino', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carrasco-Triguero', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bittner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Ostrowitzki', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200134']
1799,32563858,Capitalizing on cross-language similarities in intervention with bilingual children.,"PURPOSE


This study examined the effects of a vocabulary intervention for bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates. We measured effects in terms of change from pre- to post-intervention in Spanish as well as associations with the non-target language, English.
METHOD


Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder. Children completed the intervention in pairs (one child with DLD and a typically developing peer) for 70-minute sessions, 3 days a week, for four weeks. Intervention targeted 32 words (16 cognates, 16 non-cognates) using four storybooks (8 words/book) and interactive activities that highlighted similarities across languages. Pre- and post-intervention measures in Spanish and English included tasks of word definition and cognate facilitation.
RESULTS


As a group, children showed improvement in definition quality and cognate naming in Spanish. There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD. All children showed positive cross-language correlations on post-intervention measures.
CONCLUSIONS


Bilingual children, with and without DLD, have the capacity to improve in their awareness and use of cognates. Explicit teaching of cognates can be an effective tool for building vocabulary skills. Children with DLD may need additional time and support to apply their knowledge of cognates to vocabulary learning.",2020,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[""bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates"", 'Children with DLD', 'Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder', 'Spanish and English']",['vocabulary intervention'],"['included tasks of word definition and cognate facilitation', 'definition quality and cognate naming', 'positive cross-language correlations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0437372,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[{'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Dam', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States; University of California San Diego, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: qdam@sdsu.edu.'}, {'ForeName': 'Giang T', 'Initials': 'GT', 'LastName': 'Pham', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: gpham@sdsu.edu.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Pruitt-Lord', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: spruitt@sdsu.edu.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Limon-Hernandez', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: jlimon-hernandez@sdsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Goodwiler', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: cgoodwiler@sdsu.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106004']
1800,31622131,Incidence of Late Relapses in Patients With HER2-Positive Breast Cancer Receiving Adjuvant Trastuzumab: Combined Analysis of NCCTG N9831 (Alliance) and NRG Oncology/NSABP B-31.,"PURPOSE


Recent trials have shown potential benefit of extended adjuvant endocrine therapy and relatively high risk of recurrence (RoR) after 5 years in hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Although risk of late relapse in HR+ HER2- breast cancer is fairly well defined, the risk in HER2-positive (HER2+) breast cancer treated with adjuvant trastuzumab-based chemotherapy remains largely unknown.
METHODS


We included 3,177 patients with HER2+ breast cancer treated with adjuvant chemotherapy alone or with trastuzumab from the North Central Cancer Treatment Group N9831 (ClinicalTrials.gov identifier: NCT00005970) and National Surgical Adjuvant Breast and Bowel Project B-31 (ClinicalTrials.gov identifier: NCT00004067) trials.
RESULTS


Overall, HR+ breast cancer was significantly associated with improved recurrence-free survival (RFS) during the first 5 years (hazard ratio, 0.65; 95% CI, 0.56 to 0.77;  P  < .001). Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001). However, there was no significant difference in RFS based on HR status during years 5 to 10 (hazard ratio, 1.32; 95% CI, 0.93 to 1.88;  P  = .12). A comparable degree of trastuzumab benefit was observed in HR+ and HR- breast cancers (  P  for interaction = .87). Furthermore, we observed low RoR in years 5 to 10 among patients with HR+ HER2+ breast cancer: 3.23% in patients without lymph node involvement (N0) and 6.39% in patients with involvement of one to three lymph nodes (N1).
CONCLUSION


The benefit of adjuvant trastuzumab persists for a long time. A distinct pattern of recurrence was observed between HR+ and HR- HER2+ disease but with similar degree of benefit from adjuvant trastuzumab. RoR in years 5 to 10 in HR+ HER2+ breast cancer is low, particularly in patients with N0 or N1 disease.",2019,"Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001).","['Patients With HER2-Positive Breast Cancer Receiving', 'patients with N0 or N1 disease', '3,177 patients with HER2+ breast cancer treated with']","['adjuvant trastuzumab', 'adjuvant chemotherapy alone or with trastuzumab from the North Central Cancer Treatment', 'Adjuvant Trastuzumab']","['HR+ and HR- breast cancers', 'cumulative hazard for RFS', 'recurrence-free survival (RFS', 'Incidence of Late Relapses', 'RFS based on HR status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",3177.0,0.040459,"Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001).","[{'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Serie', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mashadi-Hossein', 'Affiliation': 'NanoString, Seattle, WA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Colon-Otero', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Song', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Pogue-Geile', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Gavin', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'E Aubrey', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00443']
1801,32548849,Duration of adhesion of swallowed alginates to distal oesophageal mucosa: implications for topical therapy of oesophageal diseases.,"BACKGROUND


We have previously shown, ex vivo, that alginate solutions can have a topical protective effect on oesophageal mucosal biopsies exposed to simulated gastric juice. Oesophageal mucosal impedance can measure the duration of mucosal adherence of ionic solutions since the impedance drops when the solution is present, and rises to baseline as the solution clears.
AIM


To investigate the in vivo duration of adhesion of swallowed alginate solution to distal oesophageal mucosa.
METHODS


We studied 20 healthy volunteers and 10 patients with heartburn. A pH-impedance catheter was inserted, and baseline distal channel oesophageal impedance measured. Healthy volunteers received 10 mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry (saline mixed with sucralose), given in a randomised, single-blinded order over three visits. Patients received either sodium alginate or placebo on two visits. Initial impedance drop was measured, then 1-minute mean impedance was measured each minute until ≥75% recovery to baseline.
RESULTS


In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01). In patients, sodium alginate adhered to the oesophageal mucosa for longer than placebo (9.0 (5.4) vs 3.7 (4.1), P < 0.01).
CONCLUSIONS


Sodium alginate solution adhered to the oesophageal mucosa for significantly longer than placebo or viscous slurry. This demonstrates that alginates could confer a protective benefit due to mucoadhesion and can be a basis for further development of topical protectants and for topical drug delivery in oesophageal disease.",2020,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","['oesophageal diseases', 'healthy volunteers', '20 healthy volunteers and 10 patients with heartburn', 'distal oesophageal mucosa', 'Healthy volunteers']","['sodium alginate or placebo', '10\xa0mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry ', 'saline mixed with sucralose', 'swallowed alginate solution', 'placebo']",['oesophageal mucosa'],"[{'cui': 'C0014852', 'cui_str': 'Disorder of esophagus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]","[{'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]",20.0,0.0734851,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Sonmez', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sifrim', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Woodland', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15884']
1802,32544846,"A fructose-based meal challenge to assess metabotypes and their metabolic risk profile: A randomized, crossover, controlled trial.","OBJECTIVES


The first aim of this study was to determine the metabolic type of individuals based on the postprandial metabolic response after the ingestion of a meal challenge that was high protein and either high glucose (high GI) or fructose (low GI). The second aim was to compare the baseline characteristics between the different metabolic types (metabotypes). The third aim was to assess whether the inclusion of fructose or glucose in a high-protein breakfast modulated the glucose, insulin, and TG response over a 4-h period.
METHODS


The study included 46 Asian women with a body mass index between 17 and 28 kg/m 2  in a randomized crossover design. Metabolic typing was based on the assessment of the postprandial glycemic, insulin and triacylglycerol (TG) response after the ingestion of two high-protein meal challenges either high in fructose or glucose. Baseline characteristics were compared between the different metabolic types. Baseline and 4-h postprandial blood samples were collected and glucose, insulin, and TG levels were analyzed. Cluster analysis was used to phenotype the participants in distinct groups. Baseline characteristics including anthropometry, glycemic, and lipid profiles and resting metabolic rate were compared among the metabolic types.
RESULTS


Cluster analysis revealed that women could be grouped into three metabolic types based on postprandial glucose, insulin, and TG response after the fructose meal challenge: cluster 1 with an average glucose + high TG response (highTG; n = 12), cluster 2 with a high glucose + average TG response (highGLU; n = 8), and cluster 3 with an average glucose + average TG response (Avg; n = 26). Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
CONCLUSIONS


Three metabolic types with a distinct metabolic response could be distinguished after a high fructose meal. The results suggest a different risk profile and may indicate why some people develop diabetes in an obesogenic environment. Improved metabolic-type assessments will enable us to develop and optimize nutritional and medical interventions for individuals with differing diabetes risk.",2020,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","['46 Asian women with a body mass index between 17 and 28 kg/m 2', 'individuals with differing diabetes risk']","['high glucose (high GI) or fructose (low GI', 'fructose-based meal challenge']","['waist-to-hip ratio', 'fasting blood glucose, body mass index, fat percentage, and hip circumference', 'glucose, insulin, and TG levels', 'glucose, insulin, and TG response', 'postprandial glycemic, insulin and triacylglycerol (TG) response', 'Baseline and 4-h postprandial blood samples', 'postprandial glucose, insulin, and TG response', 'anthropometry, glycemic, and lipid profiles and resting metabolic rate', 'postprandial metabolic response']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",46.0,0.0341195,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","[{'ForeName': 'Stefan Gerardus', 'Initials': 'SG', 'LastName': 'Camps', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Huann Rong', 'Initials': 'HR', 'LastName': 'Koh', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Nan Xin', 'Initials': 'NX', 'LastName': 'Wang', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jeya_henry@sifbi.a-star.edu.sg.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110799']
1803,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
1804,32558047,Introduction of mini-clinical evaluation exercise in teaching dental radiology-A pilot study.,"INTRODUCTION


Workplace-based assessments are methods that can be applied for assessing competence and performance. One of these methods is the mini-clinical evaluation exercise (mini-CEX). This study was conducted to determine the role of mini-CEX in students' performance assessment on panoramic X-ray reporting at dental radiology course.
MATERIALS AND METHODS


A workshop as training for the assessors and the participants was conducted before the primary test. All participants (n = 36) were randomly allocated into six groups. Each group had three seminars in which every student reported a panoramic X-ray. Students were directly observed and rated by an assessor on a modified mini-CEX rating form. Then, a self-assessment of the students and a systematic feedback session were performed. Finally, the students and the assessors were evaluated for the acceptability and satisfaction with this tool.
RESULTS


The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (P < .0001). Comparison of the results of the mini-CEX of all three assessments showed that students displayed a significantly better performance in evaluating the upper jaw and the soft tissue (P < .05). There was no significant improvement for the other aspects of the rating form. Overall, both students and assessors reported a high level of satisfaction in using the mini-CEX rating form.
CONCLUSION


Due to the objectivity and transparency of the assessment, the mini-CEX helped to improve the performance on reporting panoramic X-rays. Besides that, the structured feedback had major impact on the improvement. Overall, the assessors and the participants reported a high level of satisfaction using the rating form. Therefore, the mini-CEX may be an effective method for performing workplace-based assessments to evaluate students' performance on reporting panoramic X-rays.",2020,The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (p < 0.0001).,"['All participants (n = 36', ""students' performance assessment on panoramic x-ray reporting at dental radiology course""]","['mini-clinical evaluation exercise', 'mini-CEX']","['acceptability and satisfaction', 'mean duration of the assessment and the feedback']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",36.0,0.0264222,The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (p < 0.0001).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bock', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Peters', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elvers', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wittenborn', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kniha', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Gerressen', 'Affiliation': 'Department of Oral, Maxillofacial and Plastic Facial Surgery, Heinrich Braun Hospital, Zwickau, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Modabber', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12558']
1805,32558199,Avoidance of CNI and steroids using belatacept-Results of the Clinical Trials in Organ Transplantation 16 trial.,"Immunosuppression devoid of corticosteroids has been investigated to avoid long-term comorbidities. Likewise, alternatives to calcineurin inhibitors have been investigated as a strategy to improve long-term kidney function following transplanion. Costimulatory blockade strategies that include corticosteroids have recently shown promise, despite their higher rates of early acute rejection. We designed a randomized clinical trial utilizing depletional induction therapy to mitigate early rejection risk while limiting calcineurin inhibitors and corticosteroids. This trial, Clinical Trials in Organ Transplantation 16 (CTOT-16), sought to evaluate novel belatacept-based strategies employing tacrolimus and corticosteroid avoidance. Sixty-nine kidney transplant recipients were randomized from 4 US transplant centers comparing a control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to 2 arms using maintenance belatacept. There were no graft losses but there were 2 deaths in the control group. However, the trial was halted early because of rejection in the belatacept treatment groups. Serious adverse events were similar across groups. Although rejection was not uniform in the belatacept maintenance therapy groups, the frequency of rejection limits the practical implementation of this strategy to avoid both calcineurin inhibitors and corticosteroids at this time.",2020,Serious adverse events were similar across groups.,['69 kidney transplant recipients'],"['depletional induction therapy', 'control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to two arms using maintenance belatacept', 'tacrolimus and corticosteroid avoidance', 'calcineurin inhibitors and corticosteroids']","['graft losses', 'Serious adverse events']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",69.0,0.102752,Serious adverse events were similar across groups.,"[{'ForeName': 'Roslyn B', 'Initials': 'RB', 'LastName': 'Mannon', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alton B', 'Initials': 'AB', 'LastName': 'Farris', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Watson', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Minnie', 'Initials': 'M', 'LastName': 'Sarwal', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sigdel', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bridges', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robien', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Newell', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Larsen', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16152']
1806,32553118,"Berzosertib plus gemcitabine versus gemcitabine alone in platinum-resistant high-grade serous ovarian cancer: a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND


High-grade serous ovarian cancers show increased replication stress, rendering cells vulnerable to ATR inhibition because of near universal loss of the G1/S checkpoint (through deleterious TP53 mutations), premature S phase entry (due to CCNE1 amplification, RB1 loss, or CDKN2A mRNA downregulation), alterations of homologous recombination repair genes, and expression of oncogenic drivers (through MYC amplification and other mechanisms). We hypothesised that the combination of the selective ATR inhibitor, berzosertib, and gemcitabine could show acceptable toxicity and superior efficacy to gemcitabine alone in high-grade serous ovarian cancer.
METHODS


In this multicentre, open-label, randomised, phase 2 study, 11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting. Eligible patients were randomly assigned (1:1) to receive intravenous gemcitabine (1000 mg/m 2 ) on day 1 and day 8, or gemcitabine plus intravenous berzosertib (210 mg/m 2 ) on day 2 and day 9 of a 21-day cycle until disease progression or intolerable toxicity. Randomisation was done centrally using the Theradex Interactive Web Response System, stratified by platinum-free interval, and with a permuted block size of six. Following central randomisation, patients and investigators were not masked to treatment assignment. The primary endpoint was investigator-assessed progression-free survival, and analyses included all patients who received at least one dose of the study drugs. The study is registered with ClinicalTrials.gov, NCT02595892, and is active but closed to enrolment.
FINDINGS


Between Feb 14, 2017, and Sept 7, 2018, 88 patients were assessed for eligibility, of whom 70 were randomly assigned to treatment with gemcitabine alone (36 patients) or gemcitabine plus berzosertib (34 patients). At the data cutoff date (Feb 21, 2020), the median follow-up was 53·2 weeks (25·6-81·8) in the gemcitabine plus berzosertib group and 43·0 weeks (IQR 23·2-69·1) in the gemcitabine alone group. Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044). The most common treatment-related grade 3 or 4 adverse events were decreased neutrophil count (14 [39%] of 36 patients in the gemcitabine alone group vs 16 [47%] of 34 patients in the gemcitabine plus berzosertib group) and decreased platelet count (two [6%] vs eight [24%]). Serious adverse events were observed in ten (28%) patients in the gemcitabine alone group and nine (26%) patients in the gemcitabine plus berzosertib group. There was one treatment-related death in the gemcitabine alone group due to sepsis and one treatment-related death in the gemcitabine plus berzosertib group due to pneumonitis.
INTERPRETATION


To our knowledge, this is the first randomised study of an ATR inhibitor in any tumour type. This study shows a benefit of adding berzosertib to gemcitabine in platinum-resistant high-grade serous ovarian cancer. This combination warrants further investigation in this setting.
FUNDING


US National Cancer Institute.",2020,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","['platinum-resistant high-grade serous ovarian cancer', '88 patients were assessed for eligibility, of whom 70', '11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting', 'Eligible patients', 'Between Feb 14, 2017, and Sept 7, 2018']","['Berzosertib plus gemcitabine', 'gemcitabine plus intravenous berzosertib', 'gemcitabine alone', 'intravenous gemcitabine', 'gemcitabine plus berzosertib', 'gemcitabine', 'berzosertib to gemcitabine']","['platelet count', 'Median progression-free survival', 'neutrophil count', 'death', 'investigator-assessed progression-free survival', 'Serious adverse events']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",88.0,0.0861426,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","[{'ForeName': 'Panagiotis A', 'Initials': 'PA', 'LastName': 'Konstantinopoulos', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: panagiotis_konstantinopoulos@dfci.harvard.edu.'}, {'ForeName': 'Su-Chun', 'Initials': 'SC', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Wahner Hendrickson', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Schumer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'L Austin', 'Initials': 'LA', 'LastName': 'Doyle', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Center, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Marta A', 'Initials': 'MA', 'LastName': 'Crispens', 'Affiliation': 'Department of Obstetrics and Gynecology, Ingram Cancer Center, Vanderbilt University Nashville, TN, USA.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Olawaiye', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ira S', 'Initials': 'IS', 'LastName': 'Winer', 'Affiliation': 'Department of Obstetrics and Gynecology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Barroilhet', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin Hospital and Clinics, Madison, WI, USA.'}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McHale', 'Affiliation': 'Department of Obstetrics and Gynecology, Moores Cancer Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Färkkilä', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Dipanjan', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Roxanne S', 'Initials': 'RS', 'LastName': 'Quinn', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bowes', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': ""D'Andrea"", 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30180-7']
1807,32553888,Effect of practical hyperoxic high-intensity interval training on exercise performance.,"This study investigated the effect of a practical hyperoxic high-intensity interval training (HIIT) on aerobic and anaerobic exercise capacity. Sixteen male athletes were randomized into 2 groups: normoxic HIIT (NHIIT, n = 8) group or hyperoxic HIIT (HHIIT, n = 8) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia. All training sessions were performed until exhaustion. Participants performed maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests before and after the training period. Maximal oxygen uptake (P < 0.01) increased significantly in both groups. Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01). Mean power output during maximal exercise increased significantly only in the HHIIT group (P = 0.02). This study demonstrated that a practical hyperoxic HHIIT might be effective for improving aerobic capacity and anaerobic performance.",2020,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,['Sixteen male athletes'],"['normoxic HIIT (NHIIT, n\u2009=\u20098) group or hyperoxic HIIT (HHIIT, n\u2009=\u20098) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia', 'maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests', 'practical hyperoxic high-intensity interval training', 'practical hyperoxic high-intensity interval training (HIIT']","['Mean power output during maximal exercise', 'Blood lactate curve during submaximal exercise', 'Maximal oxygen uptake', 'aerobic capacity and anaerobic performance', 'aerobic and anaerobic exercise capacity', 'exercise performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",16.0,0.0253253,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,"[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, 101-2 Yagotohonmachi, Showa-ku, Nagoya, 466-8666, Japan; Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan. Electronic address: kon.michihiro@gmail.com.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nakagaki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan; Department of Sports Sciences, Yamanashi Gakuin University, 2-4-5 Sakaori, Kofu, Yamanashi, 400-8575, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Ebi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103481']
1808,32553922,Conditioning automatic inhibition task: Introducing a novel task to associate automatic inhibition with specific cues.,"There is growing interest in methods for conditioning automatic inhibition with specific stimuli and the potential clinical implications of these methods. For example, OCD patients were shown to benefit from a computerized training program which aimed to create an association between OCD-related cues and stopping behaviors. In the current study, we aimed to investigate the ability to condition inhibition to specific stimuli and whether such conditioning can be generalized between tasks to last over time. Participants completed 6 training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT), over a 48 -h period, in which one randomly chosen color patch was associated with inhibition. The classic Stroop task was administered before and after the CAIT training. Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping. These results demonstrate the effect of the CAIT onto one specific stimulus, and that the effect generalized between the training and testing tasks. This provides novel evidence that the CAIT can be used to facilitate faster recruitment of inhibitory resources for a specific trained stimulus, which might later help resolve cognitive conflicts that require inhibition and might also have important clinical implications.",2020,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.",[],"['Conditioning Automatic Inhibition Task', ""training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT""]",['smaller congruency and interference effects'],[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",1.0,0.0185002,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.","[{'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Hochman', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, The Hebrew University of Jerusalem, Israel. Electronic address: shacharh@post.bgu.ac.il.'}, {'ForeName': 'Shahaf', 'Initials': 'S', 'LastName': 'Leshem', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Avishai', 'Initials': 'A', 'LastName': 'Henik', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}]",Journal of neuroscience methods,['10.1016/j.jneumeth.2020.108809']
1809,32554766,Goals-of-care decision aid for critically ill patients with TBI: Development and feasibility testing.,"OBJECTIVE


To develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.
METHODS


We developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.
RESULTS


The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent""). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician-family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.
CONCLUSIONS


Our systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.",2020,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","['18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label', '16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date', 'critically ill patients with TBI', 'patients who are critically ill with traumatic brain injury (ciTBI']","['36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing']",['acceptability'],"[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",12.0,0.089653,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Muehlschlegel', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA. susanne.muehlschlegel@umassmemorial.org.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Hwang', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Flahive', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Moskowitz', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Goostrey', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jolanta J', 'Initials': 'JJ', 'LastName': 'Pach', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Knies', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Shutter', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldberg', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}]",Neurology,['10.1212/WNL.0000000000009770']
1810,32560516,"Body Fat Changes and Liver Safety in Obese and Overweight Women Supplemented with Conjugated Linoleic Acid: A 12-Week Randomised, Double-Blind, Placebo-Controlled Trial.","Preliminary evidence suggests that conjugated linoleic acid (CLA) may reduce body weight and affect body composition. The present study assessed the effect of CLA supplementation on body fat composition in overweight and obese women, while also evaluating the liver safety of CLA use. Seventy-four obese or overweight women were randomly assigned to receive 3 g/day CLA or placebo for 12 weeks. Body composition (dual-energy X-ray absorptiometry) and liver function ( 13 C-methacetin breath test and serum liver enzymes) were assessed before and after the trial. Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p  = 0.0007) and percentage ( p  = 0.0006), android adipose tissue ( p  = 0.0002), gynoid adipose tissue ( p  = 0.0028), and visceral adipose tissue ( p  = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p  = 6.1 × 10 -11 ) when compared to those receiving a placebo. The maximum momentary 13C recovery changes and end-point values were significantly higher in the CLA group when compared to the placebo group ( p  = 0.0385 and  p  = 0.0076, respectively). There were no significant changes in alanine aminotransferase, asparagine aminotransferase, and gamma-glutamyl transpeptidase activities between the groups. In conclusion, CLA supplementation was well tolerated and safe for the liver, which shows beneficial effects on fat composition in overweight and obese women.",2020,"Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p  = 0.0007) and percentage ( p  = 0.0006), android adipose tissue ( p  = 0.0002), gynoid adipose tissue ( p  = 0.0028), and visceral adipose tissue ( p  = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p  ","['Seventy-four obese or overweight women', 'overweight and obese women', 'Obese and Overweight Women Supplemented with']","['CLA supplementation', 'Placebo', 'conjugated linoleic acid (CLA', 'placebo', 'CLA or placebo', 'Conjugated Linoleic Acid', 'CLA']","['maximum momentary 13C recovery changes and end-point values', 'Body Fat Changes and Liver Safety', 'visceral adipose tissue', 'alanine aminotransferase, asparagine aminotransferase, and gamma-glutamyl transpeptidase activities', 'body fat composition', 'total body fat', 'tolerated and safe', 'Body composition (dual-energy X-ray absorptiometry) and liver function ( 13 C-methacetin breath test and serum liver enzymes', 'gynoid adipose tissue', 'android adipose tissue', 'lean body mass to height', 'body weight and affect body composition']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0074380', 'cui_str': 'Serine-glyoxylate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0066070', 'cui_str': 'methacetin'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",74.0,0.162104,"Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p  = 0.0007) and percentage ( p  = 0.0006), android adipose tissue ( p  = 0.0002), gynoid adipose tissue ( p  = 0.0028), and visceral adipose tissue ( p  = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p  ","[{'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Mądry', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Ida Judyta', 'Initials': 'IJ', 'LastName': 'Malesza', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Czochralska-Duszyńska', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Walkowiak', 'Affiliation': 'Division of Reproduction, Department of Gynecology and Obstetrics, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Miśkiewicz-Chotnicka', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': 'Department of Clinical Auxology and Pediatric Nursing, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}]",Nutrients,['10.3390/nu12061811']
1811,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069']
1812,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS


The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity.
DISCUSSION


Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population.
TRIAL REGISTRATION


ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070']
1813,32570710,"Anti-Heartburn Effects of Sugar Cane Flour: A Double-Blind, Randomized, Placebo-Controlled Study.","Gastroesophageal reflux disease (GERD) affects approximately 20% of Australians. Patients suffer a burning sensation known as heartburn due to the movement of acidic stomach content into the esophagus. There is anecdotal evidence of the effectiveness of prebiotic sugarcane flour in controlling symptoms of GERD. This pilot study aimed to investigate the effectiveness of a prebiotic sugarcane flour in alleviating symptoms in medically-diagnosed GERD patients. This pilot study was a single center, double-blinded, placebo-controlled randomized trial conducted on 43 eligible participants. The intervention group ( n  = 22) were randomized to receive 3 g of sugarcane flour per day, and the control group ( n  = 21) received 3 g of cellulose placebo per day. Symptoms of gastroesophageal reflux disease were assessed before and after three weeks treatment using the validated Gastroesophageal Reflux Disease-Health Related Quality of Life questionnaire (GERD-HRQL). After three weeks there were significant differences in symptoms for heartburn, regurgitation, and total symptoms scores ( p  < 0.05) between the sugarcane flour and placebo. Mean GERD-HRQL scores increased in the placebo group for regurgitation (mean increase 1.7; 95% CI 0.23 to 3.2;  p  = 0.015) and total symptom scores (2.9; 95% CI 0.26 to 5.7;  p  = 0.033). In contrast, there were significant reductions in heartburn (mean decrease -2.2; 95% CI -4.2 to -0.14;  p  = 0.037) and total symptom scores (-3.7; 95% CI -7.2 to -0.11;  p  = 0.044) in the intervention group. This pilot study has shown significant positive effects of sugarcane flour in the reduction of GERD symptoms, and a larger randomized controlled trial is warranted.",2020,"After three weeks there were significant differences in symptoms for heartburn, regurgitation, and total symptoms scores ( p  < 0.05) between the sugarcane flour and placebo.","['medically-diagnosed GERD patients', '43 eligible participants']","['Placebo', 'prebiotic sugarcane flour', 'Sugar Cane Flour', 'sugarcane flour', '3 g of cellulose placebo', 'placebo']","['Symptoms of gastroesophageal reflux disease', 'symptoms for heartburn, regurgitation, and total symptoms scores', 'Mean GERD-HRQL scores', 'validated Gastroesophageal Reflux Disease-Health Related Quality of Life questionnaire (GERD-HRQL', 'total symptom scores', 'Gastroesophageal reflux disease (GERD', 'heartburn']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0997177', 'cui_str': 'Sugarcane'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",43.0,0.58222,"After three weeks there were significant differences in symptoms for heartburn, regurgitation, and total symptoms scores ( p  < 0.05) between the sugarcane flour and placebo.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Beckett', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, TAS 7250, Australia.'}, {'ForeName': 'Neeraj K', 'Initials': 'NK', 'LastName': 'Singh', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, TAS 7250, Australia.'}, {'ForeName': 'Jehan', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'First Point Healthcare, Launceston, TAS 7250, Australia.'}, {'ForeName': 'Krishnakumar', 'Initials': 'K', 'LastName': 'Kalpurath', 'Affiliation': 'Mersey Community Hospital, Latrobe, TAS 7307, Australia.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': 'KFSU Pty Ltd., Ayr, QLD 4807, Australia.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Stanley', 'Affiliation': 'Centre for Food Innovation, Tasmanian Institute of Agriculture, University of Tasmania, Launceston 7250, Australia.'}, {'ForeName': 'Rajaraman D', 'Initials': 'RD', 'LastName': 'Eri', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, TAS 7250, Australia.'}]",Nutrients,['10.3390/nu12061813']
1814,32571614,Effects of diet and exercise on adipocytokine levels in patients with moderate to severe chronic kidney disease.,"BACKGROUND AND AIMS


Obesity is a pro-inflammatory risk factor for progression of CKD and cardiovascular disease. We hypothesized that implementation of caloric restriction and endurance exercise would improve adipocytokine profiles in patients with moderate to severe CKD.
METHODS AND RESULTS


We enrolled patients with moderate to severe CKD through a multi-center pilot randomized trial of diet and exercise in a 4-arm design (dietary restriction of 10%-15% reduction in caloric intake, exercise three times/week, combined diet and exercise, and control) (NCT01150851). Adipocytokines (adiponectin and leptin) were measured at the beginning and end of the study period as secondary outcomes. Treatment effect was analyzed in a multivariable model adjusted for baseline outcome values, age, gender, site and diabetes. A total of 122 participants were consented, 111 were randomized (42% female, 25% diabetic, and 91% hypertensive), 104 started intervention and 92 completed the study (Figure 1). Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment.
CONCLUSION


Our data suggest that dietary caloric restriction increases plasma adiponectin levels in stage 3-4 CKD patients, with limited effect on leptin levels. These findings suggest the potential for improving the metabolic milieu of CKD with moderate calorie restriction.",2020,"Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment.
","['A total of 122 participants were consented, 111 were randomized (42% female, 25% diabetic, and 91% hypertensive), 104 started intervention and 92 completed the study (Figure\xa01', 'enrolled patients with moderate to severe CKD through a multi-center pilot randomized trial of', 'patients with moderate to severe CKD', 'patients with moderate to severe chronic kidney disease']","['diet and exercise', 'dietary caloric restriction', 'diet and exercise in a 4-arm design (dietary restriction of 10%-15% reduction in caloric intake, exercise three times/week, combined diet and exercise, and control) (NCT01150851', 'caloric restriction and endurance exercise']","['Adipocytokines (adiponectin and leptin', 'plasma adiponectin levels', 'adipocytokine levels', 'Plasma adiponectin levels', 'circulating leptin', 'adipocytokine profiles', 'leptin levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",122.0,0.0257898,"Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment.
","[{'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Aydemir', 'Affiliation': 'Hitit University Medical School, Nephrology Department, Corum, Turkey.'}, {'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Pike', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Aseel', 'Initials': 'A', 'LastName': 'Alsouqi', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Samuel A E', 'Initials': 'SAE', 'LastName': 'Headley', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA; Providence Medical Research Center, Providence Health Care, Spokane, WA, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Milch', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Kelsey A', 'Initials': 'KA', 'LastName': 'Moody', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Germain', 'Affiliation': 'Department of Nephrology, Bay State Medical Center, Springfield, MA, USA.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Lipworth', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Himmelfarb', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Ikizler', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Cassianne', 'Initials': 'C', 'LastName': 'Robinson-Cohen', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: cassianne.robinson-cohen@vumc.edu.""}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.012']
1815,32571773,"Oseltamivir for coronavirus illness: post-hoc exploratory analysis of an open-label, pragmatic, randomised controlled trial in European primary care from 2016 to 2018.","BACKGROUND


Patients infected with the novel coronavirus (SARS-CoV-2) are being treated empirically with oseltamivir, but there is little evidence from randomised controlled trials to support the treatment of coronavirus infections with oseltamivir.
AIM


To determine whether adding oseltamivir to usual care reduces time to recovery in symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2).
DESIGN AND SETTING


Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries.
METHOD


Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2), were randomised to usual care or usual care plus oseltamivir. The primary outcome was time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache.
RESULTS


Coronaviruses (CoV-229E, CoV-OC43, CoV-KU1 and CoV-NL63) were identified in 308 (9%) out of 3266 randomised participants in the trial; 153 of these were allocated to usual care and 155 to usual care plus oseltamivir; the primary outcome was ascertained in 136 and 147 participants, respectively. The median time to recovery was shorter in patients randomised to oseltamivir: 4 days (interquartile range [IQR] 3-6) versus 5 days (IQR 3-8; hazard ratio 1.31; 95% confidence interval = 1.03 to 1.66;  P  = 0.026).
CONCLUSION


Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone. This may be of relevance to the primary care management of COVID-19.",2020,"CONCLUSION


Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","['Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2', 'Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2', 'coronavirus illness', 'Patients infected with the novel coronavirus (SARS-CoV-2', 'European primary care from 2016 to 2018', 'Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries', 'symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2']","['usual care plus oseltamivir', 'oseltamivir', 'Oseltamivir', 'usual care or usual care plus oseltamivir']","['time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache', 'median time to recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3266.0,0.207108,"CONCLUSION


Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Centre for General Practice, Department of Family Medicine & Health Policy (FAMPOP); Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cianci', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants, Austin, Texas, US; adjunct assistant professor, Vanderbilt University, Department of Biostatistics, Nashville, Tennessee, US.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Muireann', 'Initials': 'M', 'LastName': 'de Paor', 'Affiliation': 'Department of General Practice, Royal College of Surgeons in Ireland School of Medicine, Dublin, Ireland.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Ieven', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711941']
1816,32543876,Manual Physical Therapy in the Treatment of Functional Constipation in Children: A Pilot Randomized Controlled Trial.,"Objectives:  Make a preliminary assessment of the efficacy of manual physical therapy (MPT) compared to conventional pharmacologic treatment (CPT) in chronic pediatric functional constipation (CPC).  Design:  A pilot randomized and controlled trial was conducted.  Settings/Location:  Subjects were recruited in a tertiary university hospital in the north of Spain.  Subjects:  Forty-seven children (2-14 years) were included. Participants were assessed by Pediatric Gastroenterologist. They were recruited in a tertiary university hospital. Subjects were randomly allocated. MPT was performed in a private clinic.  Interventions:  Control group (CG) received CPT and intervention group (IG) received MPT, consisting in nine sessions of MPT with a 45-min initial session and 30 min for the rest of sessions distributed weekly during the first and second months and biweekly in the third month.  Outcome Measures:  At times 0-1-3 months and 5 years, results obtained were checked and compared, according to the defecatory pattern (""Symptom Severity Score"" SSS), quality of life (Pediatric Quality of Life Inventory Scale), Bristol Stool Form Scale (BSFS), and the defecation frequency (DF).  Results:  Results from SSS, BSFS, and DF revealed no statistically significant differences between groups in median values at any follow-up. However, there were significant changes over time. The full sample median for SSS was reduced from baseline 24 (interquartile range 20-27) to 11 (6-13) at month 1, 7 (3-13) at month 3, (8 CG; 5 IG), and 5 (1-12) at year 5. The BSFS scale increased from 2 (1-3) at baseline to 4 (3-4) at month 1 and year 5. DF increases progressively from 1 per week to 5 in the fifth year. Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores.  Conclusions:  This study gives preliminary evidence of no difference between MPT and CPT for improvement in measures of CPC, although there was some advantage for MPT in quality of life. Study results justify the conduct of a full-scale efficacy trial of MPT, as well as a noninferiority trial comparing MPT and CPT.",2020,"Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores.  ","['Subjects were recruited in a tertiary university hospital in the north of Spain', 'Functional Constipation in Children', 'chronic pediatric functional constipation (CPC', 'Subjects:  Forty-seven children (2-14 years) were included']","['Manual Physical Therapy', 'conventional pharmacologic treatment (CPT', 'CPT', 'MPT', 'manual physical therapy (MPT', 'Control group (CG', 'MPT and CPT']","['quality of life', 'total, emotional, social, and school functioning scores', 'defecatory pattern (""Symptom Severity Score"" SSS), quality of life (Pediatric Quality of Life Inventory Scale), Bristol Stool Form Scale (BSFS), and the defecation frequency (DF', 'full sample median for SSS', 'SSS, BSFS, and DF', 'BSFS scale']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",47.0,0.0551073,"Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores.  ","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Blanco Díaz', 'Affiliation': 'Surgery and Medical Surgical Specialities Department, Faculty of Medicine and Health Sciences, University of Oviedo, Oviedo, Asturias, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bousoño García', 'Affiliation': 'Paediatric Gastroenterology and Nutrition Unit, Hospital Universitario Central de Asturias (HUCA), Oviedo, Asturias, Spain.'}, {'ForeName': 'Diana Katherine', 'Initials': 'DK', 'LastName': 'Segura Ramírez', 'Affiliation': 'Paediatric Gastroenterology and Nutrition Unit, Hospital Universitario Central de Asturias (HUCA), Oviedo, Asturias, Spain.'}, {'ForeName': 'Álvaro Manuel', 'Initials': 'ÁM', 'LastName': 'Rodríguez Rodriguez', 'Affiliation': 'Independent Anthropologist, Oviedo, Asturias, Spain.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0047']
1817,32545250,"In ""High-Risk"" Infants with Sufficient Vitamin D Status at Birth, Infant Vitamin D Supplementation Had No Effect on Allergy Outcomes: A Randomized Controlled Trial.","Lower vitamin D status at birth and during infancy has been associated with increased incidence of eczema and food allergies. The aim of this study was to investigate the effect of early infancy vitamin D supplementation on allergic disease outcomes in infants at ""hereditary risk"" of allergic disease, but who had sufficient vitamin D levels at birth. Here, we report the early childhood follow-up to 2.5 years of age of ""high-risk"" infants who participated in a double-blinded, randomized controlled trial. For inclusion in this trial, late gestation (36-40 weeks) maternal 25-hydroxyvitamin D levels needed to be ≥50 nmol/L. Infants were randomized to either oral vitamin D supplementation of 400 IU/day ( n  = 97) or a placebo ( n  = 98) for the first six months of life. Vitamin D levels and allergic disease outcomes were followed up. There were no statistically significant differences in incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates between the vitamin D-supplemented and placebo groups at either 1 year or at 2.5 years of age. In conclusion, for ""allergy high-risk"" infants who had sufficient vitamin D status at birth, early infancy oral vitamin D supplementation does not appear to reduce the development of early childhood allergic disease.",2020,There were no statistically significant differences in incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates between the vitamin D-supplemented and placebo groups at either 1 year or at 2.5 years of age.,"['late gestation (36-40 weeks) maternal 25-hydroxyvitamin D levels needed to be ≥50 nmol/L. Infants', 'infants at ""hereditary risk"" of allergic disease, but who had sufficient vitamin D levels at birth', 'early childhood follow-up to 2.5 years of age of ""high-risk"" infants who participated']","['placebo', 'vitamin D-supplemented and placebo', 'oral vitamin D supplementation', 'early infancy vitamin D supplementation']","['Vitamin D levels and allergic disease outcomes', 'allergic disease outcomes', 'incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates', 'Allergy Outcomes']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}]",,0.70589,There were no statistically significant differences in incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates between the vitamin D-supplemented and placebo groups at either 1 year or at 2.5 years of age.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Rueter', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}, {'ForeName': 'Anderson P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, 15 Hospital Avenue, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Siafarikas', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}, {'ForeName': 'Ee-Mun', 'Initials': 'EM', 'LastName': 'Lim', 'Affiliation': 'Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Palmer', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}]",Nutrients,['10.3390/nu12061747']
1818,32558469,Systematic or Test-Guided Treatment for Tuberculosis in HIV-Infected Adults.,"BACKGROUND


In regions with high burdens of tuberculosis and human immunodeficiency virus (HIV), many HIV-infected adults begin antiretroviral therapy (ART) when they are already severely immunocompromised. Mortality after ART initiation is high in these patients, and tuberculosis and invasive bacterial diseases are common causes of death.
METHODS


We conducted a 48-week trial of empirical treatment for tuberculosis as compared with treatment guided by testing in HIV-infected adults who had not previously received ART and had CD4+ T-cell counts below 100 cells per cubic millimeter. Patients recruited in Ivory Coast, Uganda, Cambodia, and Vietnam were randomly assigned in a 1:1 ratio to undergo screening (Xpert MTB/RIF test, urinary lipoarabinomannan test, and chest radiography) to determine whether treatment for tuberculosis should be started or to receive systematic empirical treatment with rifampin, isoniazid, ethambutol, and pyrazinamide daily for 2 months, followed by rifampin and isoniazid daily for 4 months. The primary end point was a composite of death from any cause or invasive bacterial disease within 24 weeks (primary analysis) or within 48 weeks after randomization.
RESULTS


A total of 522 patients in the systematic-treatment group and 525 in the guided-treatment group were included in the analyses. At week 24, the rate of death from any cause or invasive bacterial disease (calculated as the number of first events per 100 patient-years) was 19.4 with systematic treatment and 20.3 with guided treatment (adjusted hazard ratio, 0.95; 95% confidence interval [CI], 0.63 to 1.44). At week 48, the corresponding rates were 12.8 and 13.3 (adjusted hazard ratio, 0.97 [95% CI, 0.67 to 1.40]). At week 24, the probability of tuberculosis was lower with systematic treatment than with guided treatment (3.0% vs. 17.9%; adjusted hazard ratio, 0.15; 95% CI, 0.09 to 0.26), but the probability of grade 3 or 4 drug-related adverse events was higher with systematic treatment (17.4% vs. 7.2%; adjusted hazard ratio 2.57; 95% CI, 1.75 to 3.78). Serious adverse events were more common with systematic treatment.
CONCLUSIONS


Among severely immunosuppressed adults with HIV infection who had not previously received ART, systematic treatment for tuberculosis was not superior to test-guided treatment in reducing the rate of death or invasive bacterial disease over 24 or 48 weeks and was associated with more grade 3 or 4 adverse events. (Funded by the Agence Nationale de Recherches sur le Sida et les Hépatites Virales; STATIS ANRS 12290 ClinicalTrials.gov number, NCT02057796.).",2020,"The primary end point was a composite of death from any cause or invasive bacterial disease within 24 weeks (primary analysis) or within 48 weeks after randomization.
","['severely immunosuppressed adults with HIV infection who had not previously received ART, systematic treatment for tuberculosis', 'In regions with high burdens of tuberculosis and human immunodeficiency virus (HIV', 'Patients recruited in Ivory Coast, Uganda, Cambodia, and Vietnam', '522 patients in the systematic-treatment group and 525 in the guided-treatment group were included in the analyses', 'HIV-infected adults who had not previously received ART and had CD4+ T-cell counts below 100 cells per cubic millimeter', 'Tuberculosis in HIV-Infected Adults']","['undergo screening (Xpert MTB/RIF test, urinary lipoarabinomannan test, and chest radiography', 'rifampin, isoniazid, ethambutol, and pyrazinamide daily for 2 months, followed by rifampin and isoniazid daily for 4 months', 'antiretroviral therapy (ART']","['rate of death from any cause or invasive bacterial disease', 'probability of tuberculosis', 'composite of death from any cause or invasive bacterial disease', 'Mortality', 'rate of death or invasive bacterial disease', 'probability of grade 3 or 4 drug-related adverse events', 'Serious adverse events']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1300557', 'cui_str': '/mm3'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.424958,"The primary end point was a composite of death from any cause or invasive bacterial disease within 24 weeks (primary analysis) or within 48 weeks after randomization.
","[{'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Blanc', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Anani D', 'Initials': 'AD', 'LastName': 'Badje', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Maryline', 'Initials': 'M', 'LastName': 'Bonnet', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Messou', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Muzoora', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Sovannarith', 'Initials': 'S', 'LastName': 'Samreth', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Bang D', 'Initials': 'BD', 'LastName': 'Nguyen', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Borand', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Domergue', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Rapoud', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Naome', 'Initials': 'N', 'LastName': 'Natukunda', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Sopheak', 'Initials': 'S', 'LastName': 'Thai', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Juchet', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholié', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Lawn', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Serge K', 'Initials': 'SK', 'LastName': 'Domoua', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Laureillard', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1910708']
1819,32553642,Love at first taste: Activation in reward-related brain regions during single-trial naturalistic appetitive conditioning in humans.,"Palatable food can trigger appetitive responses, such as salivation and approach tendencies. Though evolutionarily functional, these conditioned responses can encourage overeating and obesity when food is abundant. The current study examines the neural correlates of 'denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US) during a single trial. To do so, 23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS-). After this single-trial conditioning procedure, participants viewed and rated images of the marzipan figures and the control objects during functional magnetic resonance imaging (fMRI). Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling. Furthermore, conditioning effects in subjective 'craving', defined as increased palatability and desire to eat, were observed, and these were positively related to conditioning effects in the amygdala, a brain region associated with the need-dependent value of a reward. Thus, the study identified reward-related brain regions involved in single-trial appetitive learning, thereby providing a potential mechanism that contributes to the etiology of food craving. These findings might help to understand clinically relevant food cravings in individuals with eating or weight related concerns and might support the development of extinction based treatments.",2020,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","['23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS', 'humans']","[""denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US""]","[""subjective 'craving"", 'palatability and desire to eat']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]",23.0,0.0298472,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","[{'ForeName': 'Lender', 'Initials': 'L', 'LastName': 'A', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria. Electronic address: anja.lender@sbg.ac.at.'}, {'ForeName': 'Miedl', 'Initials': 'M', 'LastName': 'Sf', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychopathology, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 15020 Salzburg, Austria.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Fh', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychopathology, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 15020 Salzburg, Austria.'}, {'ForeName': 'Miller', 'Initials': 'M', 'LastName': 'J', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}, {'ForeName': 'Blechert', 'Initials': 'B', 'LastName': 'J', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113014']
1820,32553717,Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.,"OBJECTIVES


The aim was to fully characterize the plasma and urine washout pharmacokinetics of tenofovir (TFV) in adults following 6 weeks of controlled levels of tenofovir disoproxil fumarate (TDF) adherence, in order to inform the utility of clinic-based adherence testing.
DESIGN


This was a three-arm, randomized, open-label study in adult volunteers. Participants were randomized to receive TDF 300 mg/emtricitabine (FTC) 200 mg as (1) 7 doses/week (perfect adherence), (2) 4 doses/week (moderate adherence), or (3) 2 doses/week (low adherence). Plasma and urine samples were collected regularly during the 6-week dosing phase and for 4 weeks following drug cessation.
RESULTS


Twenty-eight adults were included in this analysis. Median (range) age was 33 (20-49) years. No differences in TFV pharmacokinetic parameters during the washout were observed across the study arms. Small differences in TFV plasma concentrations occurred across arms between 4 and 10 h post-dose. The cumulative amount of TFV excreted in urine was not different at 24 h post-dose, but at 148 h it was 24.8 mg, 21.0 mg, and 17.2 mg for the perfect, moderate, and low adherence arms, respectively (p = 0.043).
CONCLUSIONS


Among adults with different TDF adherence patterns, relative differences in plasma concentrations and cumulative urine extraction of TFV were minor following cessation. TFV measurement in plasma or urine is more indicative of last drug ingestion, rather than prior dose patterns.",2020,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","['Adults with Controlled Levels of Adherence to', 'adult volunteers', 'adults with different TDF adherence patterns', 'Median (range) age was 33 (20-49) years', 'Twenty-eight adults']","['Tenofovir Disoproxil Fumarate', 'TDF 300\u2009mg/emtricitabine (FTC']","['Plasma and urine samples', 'cumulative amount of TFV excreted in urine', 'TFV PK parameters', 'Plasma Pharmacokinetics and Urinary Excretion of Tenofovir', 'plasma concentrations and cumulative urine extraction of TFV', 'TFV measurement in plasma or urine', 'TFV plasma concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",28.0,0.0747984,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","[{'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand; Department of Immunology and Infectious Diseases, Boston, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. Electronic address: tim.cressey@phpt.org.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, CA, USA.'}, {'ForeName': 'Yardpiroon', 'Initials': 'Y', 'LastName': 'Tawon', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, CA, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, USA.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.037']
1821,32551868,"Maximum Bridging Suture Tension Provides Better Clinical Outcomes in Transosseous-Equivalent Rotator Cuff Repair: A Clinical, Prospective Randomized Comparative Study.","BACKGROUND


Some studies reporting clinical outcomes after transosseous-equivalent (TOE) repair have attributed type II rotator cuff failure to excessive bridging suture tension, as it can cause overloading on the medial row. In a previous biomechanical cadaveric study, increasing bridging suture tension over 90 N did not improve the contact area and ultimate failure load of the TOE construct, despite increasing the contact force and contact pressure.
PURPOSE


To compare the clinical outcomes of different bridging suture tensions after TOE rotator cuff repair based on the results of a previous biomechanical study.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 78 patients who underwent arthroscopic rotator cuff repair for medium- to large-sized tears were prospectively enrolled and randomly divided into 2 groups according to the applied bridging suture tension: optimum tension group (96.3 ± 4.9 N) and maximum tension group (199.0 ± 20.3 N). Bridging suture tension was measured with a customized tensiometer, as used in the previous biomechanical study. The functional outcome was measured at the final follow-up (27.4 ± 5.9 months [range, 24-45 months]) using the visual analog scale for pain, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Constant score, and the anatomic outcome was evaluated using magnetic resonance imaging or ultrasonography at least 12 months after surgery.
RESULTS


Overall, 64 patients (32 in each group) were analyzed. The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05). Regarding the anatomic outcomes, the maximum tension group (n = 1; 3.1%) had a significantly lower healing failure rate than the optimum tension group (n = 9; 28.1%) ( P  = .013). One patient in the maximum tension group had a type II failure.
CONCLUSION


Maximum bridging suture tension in TOE repair for medium- to large-sized rotator cuff tears provided better anatomic healing with less risk of medial rotator cuff failure, which differs from the results of a previous time-zero biomechanical study.",2020,The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05).,"['Transosseous-Equivalent Rotator Cuff Repair', '78 patients who underwent arthroscopic rotator cuff repair for medium- to large-sized tears', '64 patients (32 in each group) were analyzed']","['Maximum Bridging Suture Tension', 'Maximum bridging suture tension in TOE repair for medium- to large-sized rotator cuff tears', 'bridging suture tension: optimum tension group (96.3 ± 4.9 N) and maximum tension', 'bridging suture tensions after TOE rotator cuff repair', 'transosseous-equivalent (TOE) repair']","['visual analog scale for pain, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Constant score, and the anatomic outcome', 'healing failure rate', 'type II failure']","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",78.0,0.0432952,The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05).,"[{'ForeName': 'Joo Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Ji Soon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Healthpoint, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Rhee', 'Affiliation': 'Shoulder and Elbow Clinic, Department of Orthopedic Surgery, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Bundang Jesaeng General Hospital, Daejin Medical Center, Seongnam, Republic of Korea.'}]",The American journal of sports medicine,['10.1177/0363546520930425']
1822,32559515,Fampridine-induced changes in walking kinetics are associated with clinical improvements in patients with multiple sclerosis.,"Gait dysfunction is common in patients with multiple sclerosis (PwMS). Treatment with prolonged-release fampridine (PR-fampridine) improves walking ability in some PwMS. Associated fampridine-induced changes in the walking pattern are still poorly understood but may provide a better understanding of the mechanisms underlying the beneficial drug effects. 61 PwMS were treated with PR-fampridine in a randomized, monocentric, double-blind and placebo-controlled clinical trial with crossover design (FAMPKIN). Drug-induced improvements in walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT) were quantified. In this sub-study of the FAMPKIN trial, fampridine-induced changes in kinetic gait patterns were analyzed by pressure-based foot print analysis during treadmill walking. Vertical ground reaction forces were analyzed during different gait phases. Kinetic data of 44 PwMS was eligible for analysis. During double-blind treatment with PR-fampridine, patients performed significantly better in the T25FW and 6MWT than during placebo treatment (p < 0.0001 for both). At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo. However, we found relevant changes of walking kinetics regarding forces during loading, single limb and pre-swing phase in a patient sub-group (n = 8). Interestingly, this sub-group demonstrated superior responsiveness to PR-fampridine in the clinical walking tests compared to those patients without any fampridine-induced changes in kinetics (n = 36). Our results demonstrate fampridine-induced changes in gait kinetics in a sub-group of PwMS. These gait pattern changes were accompanied by improved clinical walking performance under PR-fampridine. These results shed some light on the biomechanical changes in walking patterns underlying enhanced fampridine-induced gait performance.",2020,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","['patients with multiple sclerosis', 'patients with multiple sclerosis (PwMS']","['PR-fampridine', 'prolonged-release fampridine (PR-fampridine', 'placebo']","['clinical walking performance', 'Vertical ground reaction forces', 'walking kinetics', 'gait kinetics', 'Gait dysfunction', 'walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT', 'kinetic gait patterns', 'T25FW and 6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",61.0,0.124543,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lörincz', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sutter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Linnebank', 'Affiliation': 'Department of Neurology, University Witten/Herdecke and Evangelische Kliniken Gelsenkirchen, Munckelstraße 32, 45879 Gelsenkirchen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zörner', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Filli', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland; Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland; Swiss Center for clinical Movement Analysis (SCMA), Balgrist Campus AG, Lengghalde 5, 8008 Zurich, Switzerland. Electronic address: linard.filli@balgrist.ch.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116978']
1823,32559601,Cardiovascular responses to pelvic floor muscle contraction in healthy women: Prospective study.,"OBJECTIVE


Analyze the acute heart rate and blood pressure responses to two protocols of pelvic floor muscles contractions in premenopausal and postmenopausal women.
METHODS


Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal. The groups underwent two protocols and the pelvic floor muscle endurance, heart rate, and blood pressure values were monitored. Both protocols included 10 pelvic floor muscles contractions; one series contained contractions lasting 5 s with 5 s of rest between each contraction and the other series contained contractions lasting 10 s with 10 s of rest.
RESULTS


In both groups, there was a significant increase in the heart rate during pelvic floor muscles contractions (premenopausal: 71.0 ± 7.3 and 80.3 ± 7.7; postmenopausal: 65.4 ± 6.6 and 73.6 ± 6.6, at rest and contractions peak, respectively) and in systolic blood pressure immediately after the contractions. The observed values during exercise returned to basal values seconds after the contractions. A positive correlation between heart rate and vaginal squeeze pressure (r = 0.45, p = 0.0007 and r = 0.48, p = 0.0003, 5- and 10-s series, respectively) was observed.
CONCLUSION


The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.",2020,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"['premenopausal and postmenopausal women', 'healthy women', 'healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions', 'Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal']",['pelvic floor muscles contractions'],"['heart rate and blood pressure', 'pelvic floor muscle endurance, heart rate, and blood pressure values', 'heart rate', 'Cardiovascular responses', 'systolic blood pressure', 'heart rate and vaginal squeeze pressure']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",54.0,0.0281104,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"[{'ForeName': 'Alana Maria G', 'Initials': 'AMG', 'LastName': 'Bastos', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Soraia P', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Grasiela N', 'Initials': 'GN', 'LastName': 'Correia', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Perseguini', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil. Electronic address: pdriusso@ufscar.br.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.050']
1824,32575383,Effect of Mental Fatigue on Postural Sway in Healthy Older Adults and Stroke Populations.,"The aim of this study was to examine the effect of mental fatigue on postural sway under different sensory conditions in healthy older adults and in persons with chronic stroke (PwCS). Thirty healthy older adults (> 60 years old), randomly separated into experimental and control groups, as well as 15 PwCS participated in this study. Experimental groups were asked to stand on a force platform wearing seven inertial sensors while performing the Sensory Organization Test (SOT) under two cognitive conditions (single- and dual-task) before and after a mental fatigue task (stop-signal task for 60 min). The control group performed the same protocol before and after watching a movie for 60 min. Changes in subjective fatigue was assessed by the NASA Task Load Index and psychophysiological workload was assessed by heart rate variability (HRV). Postural sway was assessed by calculating the Jerk and root mean square (RMS) of center of mass (COM). Higher Jerk and RMS of COM ( p  < 0.05) were observed after the mental fatigue task in both healthy older adults and PwCS during SOT, which was not observed in the control group ( p  > 0.05). Additionally, postural sway increased in the three groups as the SOT conditions became more challenging. Our results indicate that mental fatigue, induced by sustained cognitive activity, can impair balance during SOT in older adult and stroke populations.",2020,"Higher Jerk and RMS of COM ( p  < 0.05) were observed after the mental fatigue task in both healthy older adults and PwCS during SOT, which was not observed in the control group ( p  > 0.05).","['Thirty healthy older adults (> 60 years old', 'healthy older adults and in persons with chronic stroke (PwCS', 'Healthy Older Adults and Stroke Populations']","['force platform wearing seven inertial sensors while performing the Sensory Organization Test (SOT) under two cognitive conditions (single- and dual-task', 'mental fatigue on postural sway under different sensory conditions', 'Mental Fatigue']","['Higher Jerk and RMS of COM', 'Postural sway', 'Postural Sway', 'subjective fatigue', 'NASA Task Load Index and psychophysiological workload', 'Jerk and root mean square (RMS) of center of mass (COM', 'heart rate variability (HRV', 'postural sway']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0009490', 'cui_str': 'Comoros islands'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}]",30.0,0.0208196,"Higher Jerk and RMS of COM ( p  < 0.05) were observed after the mental fatigue task in both healthy older adults and PwCS during SOT, which was not observed in the control group ( p  > 0.05).","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Varas-Diaz', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Kannan', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Bhatt', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Brain sciences,['10.3390/brainsci10060388']
1825,32575387,Snacking on Whole Almonds for Six Weeks Increases Heart Rate Variability during Mental Stress in Healthy Adults: A Randomized Controlled Trial.,"Cardiac autonomic regulation can be indirectly measured by heart rate variability (HRV). Low HRV, which can be induced by mental stress, is a predictor of risk of sudden cardiac death. Few studies have investigated cause-and-effect relationships between diet and HRV. Nut consumption is associated with CVD risk reduction, but the impact on HRV, particularly in response to stress, is unclear. Men and women (30-70 y) with above average risk of developing CVD were randomly assigned in a 6-week randomized, controlled, parallel arm trial to consume either whole almond or isocaloric control snacks (20% of daily estimated energy requirement). Control snacks contained the average nutrient profile of UK snacks. Five-minute periods of supine heart rate (HR) and HRV were measured at resting and during mental stress (Stroop color-word test) at baseline and six weeks. High frequency (HF) power, which reflects parasympathetic regulation of HR, was increased following almonds during the mental stress task relative to control (mean difference between groups 124 ms2; 95% CI 11, 237;  p  = 0.031,  n  = 105), but other indices were unaffected. Snacking on whole almonds instead of typical snacks may reduce risk of CVD partly by ameliorating the suppression of HRV during periods of mental stress.",2020,"High frequency (HF) power, which reflects parasympathetic regulation of HR, was increased following almonds during the mental stress task relative to control (mean difference between groups 124 ms2; 95% CI 11, 237;  ","['Healthy Adults', 'Men and women (30-70 y) with above average risk of developing CVD']",['consume either whole almond or isocaloric control snacks'],"['heart rate variability (HRV', 'average nutrient profile of UK snacks', 'High frequency (HF) power', 'supine heart rate (HR) and HRV']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]",,0.18945,"High frequency (HF) power, which reflects parasympathetic regulation of HR, was increased following almonds during the mental stress task relative to control (mean difference between groups 124 ms2; 95% CI 11, 237;  ","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Dikariyanto', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Chowienczyk', 'Affiliation': ""Department of Clinical Pharmacology, School of Cardiovascular Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London SE1 7EH, UK.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Berry', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}]",Nutrients,['10.3390/nu12061828']
1826,32584519,Development and assessment of a formal learning module to educate veterinary students in an intensive care unit about transfusion reactions.,"OBJECTIVE


To develop and assess the instructional efficacy of an online learning module on transfusion reactions in small animals and to evaluate participants' satisfaction of the module.
DESIGN


Randomized controlled trial.
SETTING


University teaching hospital.
SUBJECTS


A total of 55, fourth-year veterinary students, 27 in a treatment group that received the learning module plus standard rotation training and 28 in a control group (no module) who received only standard training INTERVENTIONS: Students received a pretest on transfusion reactions followed by administration of a transfusion reaction learning module covering recognition, treatment, prevention, case examples, and self-assessment questions for 6 common transfusion reactions. Students also received a module satisfaction survey, a post-test at 2 weeks post-module, and a retention test at 6 weeks post-module.
MEASUREMENTS AND MAIN RESULTS


Previous transfusion medicine exposure did not affect pretest scores and there was no difference in pretest scores between groups. The module group scored higher on the post-test (P < 0.001) and retention test (P = 0.002) than the control group. Mean post-test scores were 74.4% and 57.7% and mean retention test scores were 80.6% and 56.5% for the module and control groups, respectively. The module group scored higher on posttest and retention questions involving reaction recognition (P < 0.001). Students were overall very satisfied with the module with an average score of 4.8 (1-5).
CONCLUSIONS


A transfusion reaction instructional module can be delivered successfully to veterinary students on an ICU-based clinical rotation. Students taking the module scored significantly better on post-assessments up to 6 weeks after module administration as compared to students receiving only conventional clinical rotation training.",2020,The module group scored higher on the post-test (P < 0.001) and retention test (P = 0.002) than the control group.,"['educate veterinary students in an intensive care unit about transfusion reactions', 'University teaching hospital']","['online learning module', 'conventional clinical rotation training', 'learning module plus standard rotation training and 28 in a control group (no module) who received only standard training']","['posttest and retention questions involving reaction recognition', 'retention test', 'Mean post-test scores', 'mean retention test scores', 'transfusion reactions', 'instructional efficacy']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",55.0,0.0618456,The module group scored higher on the post-test (P < 0.001) and retention test (P = 0.002) than the control group.,"[{'ForeName': 'Jillian M', 'Initials': 'JM', 'LastName': 'Haines', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'K Jane', 'Initials': 'KJ', 'LastName': 'Wardrop', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindberg', 'Affiliation': 'Oregon State University Extended Campus, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Kira J', 'Initials': 'KJ', 'LastName': 'Carbonneau', 'Affiliation': 'Department of Educational Leadership, Sports Sciences, and Educational Psychology, College of Education, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'Thandeka R', 'Initials': 'TR', 'LastName': 'Ngwenyama', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'Linda G', 'Initials': 'LG', 'LastName': 'Martin', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}]","Journal of veterinary emergency and critical care (San Antonio, Tex. : 2001)",['10.1111/vec.12983']
1827,32579432,Does Happiness Improve Health? Evidence From a Randomized Controlled Trial.,"Happier people are healthier, but does becoming happier lead to better health? In the current study, we deployed a comprehensive, 3-month positive psychological intervention as an experimental tool to examine the effects of increasing subjective well-being on physical health in a nonclinical population. In a 6-month randomized controlled trial with 155 community adults, we found effects of treatment on self-reported physical health-the number of days in the previous month that participants felt healthy or sick, as assessed by questions from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System Questionnaire. In a subsample of 100 participants, we also found evidence that improvements in subjective well-being over the course of the program predicted subsequent decreases in the number of sick days. Combining experimental and longitudinal methodologies, this work provides some evidence for a causal effect of subjective well-being on self-reported physical health.",2020,"Happier people are healthier, but does becoming happier lead to better health?","[""participants felt healthy or sick, as assessed by questions from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System Questionnaire"", '155 community adults']",[],['number of sick days'],"[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C1136355', 'cui_str': 'Behavior Risk Factor Surveillance System'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242806', 'cui_str': 'Illness Days'}]",155.0,0.0428741,"Happier people are healthier, but does becoming happier lead to better health?","[{'ForeName': 'Kostadin', 'Initials': 'K', 'LastName': 'Kushlev', 'Affiliation': 'Department of Psychology, Georgetown University.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Heintzelman', 'Affiliation': 'Department of Psychology, Rutgers University, Newark.'}, {'ForeName': 'Lesley D', 'Initials': 'LD', 'LastName': 'Lutes', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Wirtz', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Kanippayoor', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Leitner', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Diener', 'Affiliation': 'Department of Psychology, University of Virginia.'}]",Psychological science,['10.1177/0956797620919673']
1828,32553996,"The effects of a nurse-led lifestyle intervention program on cardiovascular risk, self-efficacy and health promoting behaviours among patients with metabolic syndrome: Randomized controlled trial.","BACKGROUND


Metabolic syndrome is a cluster of cardio-metabolic risk factors and a major burden for public health due to its increasing prevalence and adverse effects on cardiovascular health. Lifestyle modification is the first-line intervention for metabolic syndrome management. However, adopting healthy behaviours is challenging among patients with metabolic syndrome.
OBJECTIVE


To examine the effects of a nurse-led lifestyle intervention program on cardiovascular risks, self-efficacy and the implementation of health promoting behaviours.
DESIGN


A two-armed randomized controlled trial.
SETTINGS AND PARTICIPANTS


A total of 173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China.
METHODS


The participants were randomly assigned to either attend the lifestyle interventions (n = 86) or receive usual care from the study hospital (n = 87). The lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40 min), one educational booklet and six telephone follow-ups (bi-weekly, 20-30 min per call) in three months. The Framingham 10-year risk score was calculated to measure the participants' cardiovascular risks at baseline and 3-month. The Self-rated Abilities for Health Practices and Health Promoting Lifestyle Profile II was employed to measure the self-efficacy and health promoting behaviours at baseline, 1-month, and 3-month. The generalized estimating equation model was employed to examine the effects of the lifestyle intervention program.
RESULTS


No difference was detected in the baseline characteristics between the two groups. Decreased cardiovascular risk was found in the lifestyle intervention group, but no significant group-by-time effect was detected. The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05). Significant improvements were also detected in all subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours at 3-month (all p < 0.05).
CONCLUSIONS


The nurse-led Health Promotion Model guided lifestyle intervention program effectively improved the self-efficacy and implementation of health promoting behaviours in patients with metabolic syndrome. We recommend that nurses apply lifestyle interventions in routine care for patients with metabolic syndrome. Tweetable abstract: The RCT revealed that nurse-led lifestyle intervention was effective to improve self-efficacy and healthy behaviours among 173 MetS patients.",2020,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","['173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China', 'patients with metabolic syndrome', '173 MetS patients']","['nurses apply lifestyle interventions', 'nurse-led lifestyle intervention program', 'lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40\xa0min), one educational booklet and six telephone follow-ups', 'lifestyle interventions (n\xa0=\xa086) or receive usual care from the study hospital', 'Tweetable abstract']","['cardiovascular risks, self-efficacy', 'cardiovascular risk', 'cardiovascular risk, self-efficacy and health promoting behaviours', 'subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours', 'self-efficacy and healthy behaviours', 'Framingham 10-year risk score', 'self-efficacy and implementation of health promoting behaviours', 'self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",173.0,0.0272669,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: zhengxujuan@szu.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Pingdu People's Hospital, Qingdao, China. Electronic address: yuhongbo.doc@163.com.""}, {'ForeName': 'Xichenhui', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qiuxichenhui@163.com.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. Electronic address: sychair@cuhk.edu.hk.'}, {'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong. Electronic address: eliza.wong@polyu.edu.hk.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qunwang@szu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103638']
1829,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
1830,32555681,Improving measles vaccine uptake rates in Nigeria: An RCT evaluating the impact of incentive sizes and reminder calls on vaccine uptake.,"OBJECTIVE


To assess the impact of increasing incentive size and reminder calls on the measles vaccine uptake rate.
DESIGN


Randomized controlled trial, randomized at individual level, stratified by clinic.
SETTING


Nigeria.
PARTICIPANTS


1088 caregivers with children aged nine months or older; had received at least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number.
INTERVENTION


Nine clinics were randomized to two models; caregivers in Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN. Caregivers from the respective clinics were then randomized to one of the four arms: 1) control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call.
MAIN OUTCOME MEASURE


Receipt of measles vaccine as reported on a child health card.
RESULTS


Overall, there was no clear trend that increasing the incentive amount resulted in an increase in vaccine uptake rates. In Model 1 households, an additional 1000 NGN and 3000 NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively. This increase, however, was only significant for the 3000 NGN increase. On the other hand, in Model 2 households, increasing the incentive by 1000 NGN and 3000 NGN increased the probability by 3.3 (95% CI: -3.8-10.4, p-value = 0.36) and 3.3 (95% CI: -3.7-10.4, p-value = 0.35) percentage points. These increases were not statistically significant. Adding reminder calls to CCTs increased the probability of completing the measles vaccine; caregivers who received reminder calls plus CCTs were 5.1 percentage points more likely to get their children vaccinated (95% CI: 0.50-9.8, p-value = 0.03) compared to those who received CCTs and did not receive a reminder call. These results were largely driven by caregivers who went to clinics in Model 1.
CONCLUSION


A combination of increasing incentive amounts and reminder calls modestly improves measles immunization rates. However, this program also shows that there is substantial regional heterogeneity in response to both incentives and calls. While one possible conclusion is that a larger incentive and phone reminders are more likely to work in higher income and higher baseline coverage settings, the study is not designed to evaluate this claim. Rather, policymakers could consider experimenting with a similar low-cost calling study as part of the design of other cash transfer programs to identify whether adding reminder phone calls could increase the impact of the program.",2020,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","['Nigeria', '1088 caregivers with children aged nine months or older']","['least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number', 'control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call', 'vaccine', 'Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN', 'CCTs']","['vaccine uptake rates', 'measles immunization rates']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025010', 'cui_str': 'Measles vaccine'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]",9.0,0.319228,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Brownstone', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Connor', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0233149']
1831,32559602,Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2.,"OBJECTIVE


To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate.
STUDY DESIGN


The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here.
RESULTS


Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified.
CONCLUSION


Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.",2020,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","['women with ≥1 UF experiencing heavy menstrual bleeding (HMB', 'women with uterine fibroids', 'Women (mean age 42.5 years) were enrolled from 1 June 2015', '155 women completed the initial 12-week treatment period']","['Vilaprisan and ulipristal acetate', 'ulipristal acetate', 'vilaprisan versus placebo and ulipristal acetate', 'vilaprisan', 'placebo']","['mean menstrual blood loss', 'HMB response', 'Efficacy and safety', 'absence of bleeding/spotting by bleeding diary', 'Complete absence of bleeding/spotting', 'efficacy and safety', 'amenorrhea, controlled bleeding, decreased UF size', 'efficacy of vilaprisan', 'efficacy of vilaprisan with ulipristal acetate', 'absence of bleeding/spotting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}]",155.0,0.413833,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Karolinska University Hospital, S-171 76, Stockholm, Sweden. Electronic address: Kristina.Gemzell@ki.se.""}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029-HUS, Helsinki, Finland. Electronic address: oskari.heikinheimo@helsinki.fi.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zatik', 'Affiliation': 'Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Magan Rendelo, 48 Szent Anna utca, Debrecen, Hungary. Electronic address: jzatik@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen, Nagyerdei krt. 98, 4032, Debrecen, Hungary. Electronic address: pokar@med.unideb.hu.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': 'II Department of Gynecology, Medical University of Lublin, Racławickie 1 Street, 20-059, Lublin, Poland. Electronic address: rechbergt@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hudecek', 'Affiliation': 'Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavská 20, CZ - 625 00, Brno, Czech Republic. Electronic address: hudecek.robert@fnbrno.cz.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Petersdorf', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Kathrin.petersdorf@bayer.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramirez', 'Affiliation': 'Syneos Health, Frankfurter StraBe 233 Triforum, Haus C1 Neu-Isenburg, 63263, Germany. Electronic address: francisco.ramirez1.ext@bayer.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faustmann', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: thomas.faustmann@bayer.com.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Groettrup-Wolfers', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Esther.groettrup-wolfers@bayer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seitz', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Christian.seitz@bayer.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.043']
1832,32559644,Compensation of stochastic time-continuous perturbations during walking in healthy young adults: An analysis of the structure of gait variability.,"BACKGROUND


During everyday locomotion, we cope with various internal or external perturbations (e.g. uneven surface). Uncertainty exists on how unpredictable external perturbations increase noise within the motor system and if they are compensated by employing covariation of the limb joints or rather due to decreased sensitivity of an altered posture.
RESEARCH QUESTION


Do continuous stochastic perturbations affect the structure of gait variability in young and healthy adults?
METHODS


In a cross-over study, gait kinematics of 21 healthy young sports students were registered during treadmill walking with and without continuous stochastic perturbations. Using the TNC method, the following aspects were analyzed: (a) the sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints.
RESULTS


Compared to normal walking, gait variability was significantly increased (p < .001) during walking with perturbations. The negative effect of noise was partly compensated by improved 'covariation' of leg joints (p < .001). The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
SIGNIFICANCE


Increased motor noise due to external perturbations is partly compensated by improved covariation of the limb joints. However, the effect of an altered posture slightly affects gait variability. Further studies should focus on different populations (e.g. older participants) to see if they use the same mechanism (improved covariation) to compensate for stochastic perturbations.",2020,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","['young and healthy adults', '21 healthy young sports students', 'healthy young adults']",['treadmill walking with and without continuous stochastic perturbations'],"[""sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints"", 'gait variability', 'normal walking, gait variability', ""covariation' of leg joints""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",21.0,0.0319459,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: mq.koch@gmx.de.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Eckardt', 'Affiliation': 'Department of Sport and Movement Science, Institute of Sport Science, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany; Department for Exercise & Health, Institute of Sport Science, Leibniz University Hannover, Hannover, Germany. Electronic address: nils.eckardt@uni-oldenburg.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: astrid.zech@uni-jena.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: daniel.hamacher@uni-jena.de.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.040']
1833,32563188,"GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study.","STUDY QUESTION


Does co-administration of GnRH agonist and Human chorionic gonadotropin (hCG; dual trigger) in IVF cycles improve the number of mature oocytes and pregnancy outcome compared to hCG alone?
SUMMARY ANSWER


Using the dual trigger for final follicular maturation increases the number of oocytes, mature oocytes and number of blastocysts (total and top-quality) compared to triggering with hCG alone.
WHAT IS KNOWN ALREADY


hCG is used at the end of controlled ovarian hyperstimulation as a surrogate LH surge to induce final oocyte maturation. Recently, based on retrospective studies, the co-administration of GnRH agonist and hCG for final oocyte maturation (dual trigger) has been suggested to improve IVF outcome and pregnancy rates.
STUDY DESIGN, SIZE, DURATION


A single center, randomized controlled, double-blinded clinical trial between May 2016 and June 2018 analyzed by intention to treat (ITT).
PARTICIPANTS/MATERIALS, SETTINGS, METHODS


One hundred and fifty-five normal responder patients were randomized either to receive hCG or dual trigger for final oocyte maturation. Data on patients age, BMI, AMH, number of oocytes retrieved, number of metaphase 2 (MII) oocytes, zygotes and blastocysts, clinical pregnancy rate and live birth rate were assessed and compared between the dual trigger group and the hCG group. We performed a planned interim analysis after the recruitment of 50% of the patients. Based on the totality of outcomes at the interim analysis we decided to discontinue further recruitment.
MAIN RESULTS AND THE ROLE OF CHANCE


One hundred and fifty-five patients were included in the study. The age (36 years versus 35.3 years P = NS), BMI (24 kg/m2 versus 23.7 kg/m2) and the AMH (20.1 pmol/l versus 22.4 pmol/l) were comparable between the two groups. Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group. The clinical pregnancy rate (24.3% versus 46.1%, OR 2.65 (1.43-1.93), P = 0.009) and the live birth rate per transfer (22% versus 36.2%, OR= 1.98 (1.05-3.75), P = 0.03) were significantly higher in the dual trigger group compared to the hCG group.
LIMITATIONS, REASONS FOR CAUTION


None.
WIDER IMPLICATIONS OF THE FINDINGS


The enhanced response observed with the dual trigger might lead to better IVF outcomes were it used more widely.
STUDY FUNDING/COMPETING INTEREST(S)


The study was funded by TRIO Fertility. There are no conflicts of interest to declare.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov identifier: NCT02703584.
DATE OF TRIAL REGISTRATION


March 2016.
DATE OF FIRST PATIENT'S ENROLLMENT


May 2016.",2020,"Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group.","['One hundred and fifty-five normal responder patients', 'One hundred and fifty-five patients were included in the study', 'May 2016 and June 2018 analyzed by intention to treat (ITT', 'The age (36 years versus 35.3 years P = NS), BMI (24 kg/m2 versus 23.7 kg/m2) and the AMH (20.1 pmol/l versus 22.4 pmol/l']","['GnRH agonist and Human chorionic gonadotropin (hCG', 'hCG', 'GnRH agonist and hCG (dual trigger) versus hCG', 'GnRH agonist and hCG']","['number of oocytes, mature oocytes and number of blastocysts (total and top-quality', 'total number of blastocysts', 'clinical pregnancy rate', 'BMI, AMH, number of oocytes retrieved, number of metaphase 2 (MII) oocytes, zygotes and blastocysts, clinical pregnancy rate and live birth rate', 'IVF outcome and pregnancy rates', 'live birth rate per transfer', 'MII oocytes']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0439284', 'cui_str': 'pmol/L'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0043544', 'cui_str': 'Structure of zygote'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",155.0,0.308413,"Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bassil', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Samara', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zilberberg', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orvieto', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Casper', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa107']
1834,32562573,"Genetic variation in PEAR1, cardiovascular outcomes and effects of aspirin in a healthy elderly population.","The platelet endothelial aggregation receptor-1 (PEAR1) rs12041331 variant has been identified as a genetic determinant of platelet aggregation in response to antiplatelet therapies, including aspirin. However, association with atherothrombotic cardiovascular events is less clear, with limited evidence from large trials. Here, we tested association of rs12041331 with cardiovascular events and aspirin use in a randomized trial population of healthy older individuals. We undertook post-hoc analysis of N=13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years. Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrolment, and were randomized to either 100 mg daily low-dose aspirin or placebo for median 4.7 years follow-up. We used Cox proportional hazard regression to model the relationship between rs12041331 and the ASPREE primary cardiovascular disease endpoint (CVD), and composites of major adverse cardiovascular events (MACE) and ischaemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB). We performed whole-population analysis using additive and dominant inheritance models, then stratified by treatment group. Interaction effects between genotypes and treatment group were examined. We observed no statistically significant association (P<0.05) in the population, or by treatment group, between rs12041331 and cardiovascular or bleeding events in either model. We also found no significant interaction effects between rs12041331-A and treatment group, for CVD (P=0.65), MACE (P=0.32), STROKE (P=0.56), MHEM (P=0.59) or ICB (P=0.56). The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.",2020,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"['healthy older individuals', 'Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrolment', 'healthy elderly population', 'N=13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years']","['aspirin', 'aspirin or placebo']","['cardiovascular disease endpoint (CVD), and composites of major adverse cardiovascular events (MACE) and ischaemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB', 'Interaction effects', 'rs12041331 and cardiovascular or bleeding events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",13547.0,0.0373115,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"[{'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Riaz', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, MN, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Shuldiner', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lacaze', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1959']
1835,32563606,A phase 2 study of the bivalent VLP norovirus vaccine candidate in older adults; impact of MPL adjuvant or a second dose.,"INTRODUCTION


Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL) in this population.
METHODS


In this phase II, double-blind, controlled trial 294 healthy adults, ≥ 60 years of age, were randomized (1:1:1:1) to four groups to receive one or two intramuscular immunizations 28 days apart, with 26 18-49 year-old controls who received one MPL-free dose. One-dose groups received placebo on Day 1. Vaccine formulations contained 15 μg GI.1 and 50 μg GII.4c VLP antigens and 500 μg Al(OH) 3 , with or without 15 μg MPL. We measured histo-blood group antigen blocking (HBGA) antibodies and ELISA Ig at Days 1, 8, 29, 57, 211 and 393, and avidity indices and cell-mediated immunity (CMI). Solicited local and systemic adverse events (AE) were assessed for 7 days and unsolicited AEs for 28 days after each injection.
RESULTS


After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393. GMTs were similar across age strata (18-49, 60-74, 75-84 and ≥ 85 years of age) and unaffected by a second vaccination or MPL. Total Ig showed similar responses. No clinically relevant differences or changes in avidity or CMI were observed between formulations. Both formulations were well tolerated with no vaccine-related SAEs, the most frequent AEs being mild injection site pain and fatigue.
CONCLUSIONS


Adults over 60 years of age displayed no safety concerns and had similar immune responses to the norovirus VLP vaccine candidate as younger adults, unaffected by increasing age, a second dose or inclusion of MPL. This data supports the further development of the MPL-free vaccine candidate for older adults.",2020,After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393.,"['294 healthy adults, ≥ 60\xa0years of age', 'older adults']","['intramuscular immunizations 28\xa0days apart, with 26 18-49\xa0year-old controls who received one MPL-free dose', 'bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL', 'placebo']","['Solicited local and systemic adverse events (AE', 'avidity indices and cell-mediated immunity (CMI', 'geometric mean titres (GMTs', 'avidity or CMI']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0066776', 'cui_str': 'monophosphoryl lipid A'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020966', 'cui_str': 'Cell-Mediated Immunity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",294.0,0.41082,After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Treanor', 'Affiliation': 'University of Rochester Medical Center, School of Medicine and Dentistry, Rochester NY, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Sherwood', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland. Electronic address: Jim.Sherwood@takeda.com.'}, {'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Cramer', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Le Cam Bouveret', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Baehner', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.06.011']
1836,32563609,"Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial.","BACKGROUND


To increase the global supply of affordable IPV vaccine, preferably using Sabin viruses to comply with GAPIII requirements, Takeda has assessed three dosages of a stand-alone sIPV.
METHODS


In this phase I/II study two cohorts of 40 adults and 60 toddlers, respectively, were initially assessed for safety after receiving high-dosage sIPV compared with placebo (adults) or Salk IPV (toddlers). A cohort of 240 infants was then enrolled and randomized (1:1:1:1) to receive low-, medium- or high-dosage sIPV, or a reference Salk IPV in a three-dose primary schedule at 6, 10 and 14 weeks of age. Parents completed safety diaries for 4 weeks after each dose, and immunogenicity was measured as neutralization antibody titers at baseline and four weeks after vaccination.
RESULTS


All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants. Infants displayed dosage-dependent immune responses to sIPV when assayed using Sabin strains, which were equivalent to the reference IPV in the high-dosage sIPV group for serotypes 1 and 2, but not for Sabin and Salk serotype 3. Seroconversion rates (SCR) of the low- and medium-dosage groups were significantly lower than the Salk IPV group for both Sabin and Salk serotypes 1 and type 2 (p < 0.05), with no significant differences for Salk or Sabin serotypes 3. Responses to sIPV, particularly to Sabin types 1 and 2, were higher in initially seronegative infants, indicating possible interference by maternally-derived antibodies.
CONCLUSIONS


A novel stand-alone Sabin-based IPV vaccine was well tolerated with an acceptable safety profile, but less immunogenic than reference Salk IPV at 6, 10 and 14 weeks of age for Salk serotypes 1 and 2, with apparent interference by maternal antibodies. Additional preclinical assessments will be made before any further clinical development.",2020,All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants.,"['240 infants', '40 adults and 60 toddlers', 'healthy infants']","['Salk IPV', 'experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations', 'placebo (adults) or Salk IPV (toddlers', 'low-, medium- or high-dosage sIPV, or a reference Salk IPV']","['safety diaries', 'neutralization antibody titers', 'Safety and immunogenicity', 'Seroconversion rates (SCR']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",240.0,0.09039,All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants.,"[{'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Cramer', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Jimeno', 'Affiliation': 'Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama, USA.'}, {'ForeName': 'Htay Htay', 'Initials': 'HH', 'LastName': 'Han', 'Affiliation': 'Takeda Vaccines, Inc., Cambridge, USA. Electronic address: htay-htay.han@takeda.com.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Takeda Vaccines, Inc., Cambridge, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hartmann', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sáez-Llorens', 'Affiliation': 'Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.05.081']
1837,32564661,Transcutaneous electrical nerve stimulation is superior than placebo and control for postoperative pain relief.,"Aim:  To determine whether transcutaneous electrical nerve stimulation (TENS) is more efficient than placebo TENS and control groups for pain relief.  Design:  Randomized, single-blinded, placebo-controlled trial.  Setting & participants:  A total of 78 adults with postoperative pain, after cholecystectomy, at the University Hospital. They were randomized into active TENS, placebo TENS and control.  Intervention:  A total of 30-min interventions applied in the first 24 h after the surgery.  Outcome:  Pain intensity.  Results:  Pain significantly decreased for both TENS; however, the active TENS was better. A decrease of 2 points or more on the visual analog scale for 53.8% active TENS and 11.5% placebo.  Conclusion:  There was a greater reduction in pain of important clinical relevance in the active TENS group. Clinical Trial registration: Brazilian Clinical Trial (REBEC): RBR-6cgx2k.",2020,"Pain significantly decreased for both TENS, however the active TENS was better.","['78 adults with postoperative pain, after cholecystectomy, at the University Hospital', 'Setting & participants']","['placebo TENS', 'Transcutaneous electrical nerve stimulation', 'active TENS, placebo TENS and control', 'transcutaneous electrical nerve stimulation (TENS', 'placebo']","['Pain', 'Pain intensity', 'visual analog scale', 'postoperative pain relief', 'pain of important clinical relevance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",78.0,0.564169,"Pain significantly decreased for both TENS, however the active TENS was better.","[{'ForeName': 'Maraísa Rodrigues', 'Initials': 'MR', 'LastName': 'Borges', 'Affiliation': 'Department of Applied Physiotherapy, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Nuno Miguel Lopes', 'Initials': 'NML', 'LastName': 'de Oliveira', 'Affiliation': 'Medical School, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Izabella Barberato Silva', 'Initials': 'IBS', 'LastName': 'Antonelli', 'Affiliation': 'Department of Applied Physiotherapy, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Maristella Borges', 'Initials': 'MB', 'LastName': 'Silva', 'Affiliation': 'The study was performed at Clinics Hospital of the Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Crema', 'Affiliation': 'Medical School, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Luciane Fernanda Rodrigues Martinho', 'Initials': 'LFRM', 'LastName': 'Fernandes', 'Affiliation': 'Medical School, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}]",Pain management,['10.2217/pmt-2019-0063']
1838,32569082,Are endogenous opioid mechanisms involved in the effects of aerobic exercise training on chronic low back pain?: a randomized controlled trial.,"Aerobic exercise is believed to be an effective chronic low back pain (CLBP) intervention, although its mechanisms remain largely untested. This study evaluated whether endogenous opioid (EO) mechanisms contributed to the analgesic effects of an aerobic exercise intervention for CLBP. Individuals with CLBP were randomized to a 6-week, 18-session aerobic exercise intervention (n = 38) or usual activity control (n = 44). Before and after the intervention, participants underwent separate laboratory sessions to assess responses to evoked heat pain after receiving saline placebo or i.v. naloxone (opioid antagonist) in double-blinded, crossover fashion. Chronic pain intensity and interference were assessed before and after the intervention. EO analgesia was indexed by naloxone-placebo condition differences in evoked pain responses (blockade effects). Relative to controls, exercise participants reported significantly greater pre-post intervention decreases in chronic pain intensity and interference (p's < .04) and larger reductions in placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total). At the group level, EO analgesia (MPQ-Total blockade effects) increased significantly pre-post intervention only among female exercisers (p = .03). Dose-response effects were suggested by a significant positive association in the exercise group between exercise intensity (based on meeting heart rate targets) and EO increases (MPQ-Present Pain Intensity; p = .04). Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009). Aerobic exercise training in the absence of other interventions appears effective for CLBP management. Aerobic exercise-related enhancements in endogenous pain inhibition, in part EO-related, likely contribute to these benefits.",2020,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,['Individuals with CLBP'],"['aerobic exercise intervention', 'naloxone-placebo', 'aerobic exercise training', '18-session aerobic exercise intervention', 'naloxone (opioid antagonist', 'Aerobic exercise', 'endogenous opioid (EO', 'Aerobic exercise training', 'usual activity control', 'saline placebo']","['chronic pain intensity and interference', 'evoked pain responses', 'Chronic pain intensity and interference', 'EO analgesia (MPQ-Total blockade effects', 'placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total', 'Enhanced EO analgesia (MPQ-Total', 'EO analgesia', 'average chronic pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",44.0,0.37122,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Koltyn', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yung Hsuan', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': ""Qu'd"", 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Pain,['10.1097/j.pain.0000000000001969']
1839,32570775,Flavonoid-Rich Orange Juice Intake and Altered Gut Microbiome in Young Adults with Depressive Symptom: A Randomized Controlled Study.,"Depression is not just a general mental health problem but a serious medical illness that can worsen without treatment. The gut microbiome plays a major role in the two-way communication system between the intestines and brain. The current study examined the effects of flavonoids on depression by observing the changes in the gut microbiome and depressive symptoms of young participants consuming flavonoid-rich orange juice. The depressive symptom was assessed using the Center for Epidemiological Studies Depression Scale (CES-D), a psychiatric screening tool used to detect preexisting mental disorders. The study population was randomly divided into two groups: the flavonoid-rich orange juice (FR) and an equicaloric flavonoid-low orange cordial (FL) group. For 8 weeks, participants consumed FR (serving a daily 380 mL, 600 ± 5.4 mg flavonoids) or FL (serving a daily 380 mL, 108 ± 2.6 mg flavonoids). In total, 80 fecal samples from 40 participants (mean age, 21.83 years) were sequenced. Regarding depression, we observed positive correlations between brain-derived neurotrophic factor (BDNF) and the Lachnospiraceae family ( Lachnospiraceae_uc  and  Murimonas ) before flavonoid orange juice treatment. Most notably, the abundance of the Lachnospiraceae family ( Lachnospiraceae_uc ,  Eubacterium_g4 ,  Roseburia_uc ,  Coprococcus_g2_uc ,  Agathobacter_uc ) increased after FR treatment compared to that after FL treatment. We also validated the presence of unclassified Lachnospiraceae through sensitive real-time quantitative polymerase chain reaction using stool samples from participants before and after flavonoid treatment. Our results provide novel interventional evidence that alteration in the microbiome due to flavonoid treatment is related to a potential improvement in depression in young adults.",2020,"Most notably, the abundance of the Lachnospiraceae family ( Lachnospiraceae_uc ,  Eubacterium_g4 ,  Roseburia_uc ,  Coprococcus_g2_uc ,  Agathobacter_uc ) increased after FR treatment compared to that after FL treatment.","['young participants consuming flavonoid-rich orange juice', 'young adults', 'Young Adults with Depressive Symptom', 'In total, 80 fecal samples from 40 participants (mean age, 21.83 years) were sequenced']","['FL', 'flavonoid-rich orange juice (FR) and an equicaloric flavonoid-low orange cordial (FL) group', 'flavonoids', 'Flavonoid-Rich Orange Juice Intake']","['abundance of the Lachnospiraceae family ( Lachnospiraceae_uc ,  Eubacterium_g4 ,  Roseburia_uc ,  Coprococcus_g2_uc ,  Agathobacter_uc ', 'depressive symptom']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0325205,"Most notably, the abundance of the Lachnospiraceae family ( Lachnospiraceae_uc ,  Eubacterium_g4 ,  Roseburia_uc ,  Coprococcus_g2_uc ,  Agathobacter_uc ) increased after FR treatment compared to that after FL treatment.","[{'ForeName': 'Miey', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Korea.'}, {'ForeName': 'Jihee', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Korea.'}]",Nutrients,['10.3390/nu12061815']
1840,32570811,"Leucine-Enriched Protein Supplementation Increases Lean Body Mass in Healthy Korean Adults Aged 50 Years and Older: A Randomized, Double-Blind, Placebo-Controlled Trial.","Early prevention of sarcopenia could be an important strategy for muscle retention, but most studies have focused on subjects aged 65 or older. Therefore, in this study we investigated the effects of leucine-enriched protein supplementation on muscle condition in a sample including late middle-aged adults. A 12-week intervention was performed for 120 healthy community-dwelling adults by providing either leucine-enriched protein supplement [leucine 3 g, protein mixture (casein 50% + whey 40% + soy 10%) 17 g, vitamin D 800IU (20 µg), calcium 300 mg, fat 1.1 g, carbohydrate 2.5 g] or isocaloric carbohydrate supplement twice per day. Appendicular skeletal muscle mass index (ASMI) and lean body mass (LBM) were measured by dual-energy X-ray absorptiometry. A total of 111 participants completed the study, with a dropout rate of 9.2%. LBM normalized by height and body weight (LBM/Wt) was significantly increased ( p  < 0.001) in the intervention group (0 wk: 633.9 ± 8.5 vs. 12 wk 636.9 ± 8.4 in the intervention group; 0 wk: 638.6 ± 8.3 vs. 12 wk: 632.9 ± 8.1 in the control group). In subgroup analyses, significant differences remained only in subjects between 50 and 64 years of age. We concluded that leucine-enriched protein supplementation can have beneficial effects by preventing muscle loss, mainly for late middle-aged adults.",2020,LBM normalized by height and body weight (LBM/Wt) was significantly increased ( p  < 0.001) in the intervention group (0 wk: 633.9 ± 8.5 vs. 12 wk 636.9 ± 8.4 in the intervention group; 0 wk: 638.6 ± 8.3 vs. 12 wk: 632.9 ± 8.1 in the control group).,"['120 healthy community-dwelling adults by providing either', 'subjects aged 65 or older', 'A total of 111 participants completed the study, with a dropout rate of 9.2', 'Aged 50 Years and Older', 'muscle condition in a sample including late middle-aged adults', 'late middle-aged adults', 'Healthy Korean Adults']","['Placebo', 'leucine-enriched protein supplement [leucine 3 g, protein mixture (casein 50% + whey 40% + soy 10', 'Leucine-Enriched Protein Supplementation', 'vitamin D 800IU (20 µg), calcium 300 mg, fat 1.1 g, carbohydrate 2.5 g] or isocaloric carbohydrate supplement', 'leucine-enriched protein supplementation']","['Appendicular skeletal muscle mass index (ASMI) and lean body mass (LBM', 'Lean Body Mass', 'LBM normalized by height and body weight (LBM/Wt']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",120.0,0.291926,LBM normalized by height and body weight (LBM/Wt) was significantly increased ( p  < 0.001) in the intervention group (0 wk: 633.9 ± 8.5 vs. 12 wk 636.9 ± 8.4 in the intervention group; 0 wk: 638.6 ± 8.3 vs. 12 wk: 632.9 ± 8.1 in the control group).,"[{'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yong-in 17104, Korea.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yong-in 17104, Korea.'}, {'ForeName': 'Yong Jun', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Yunhwan', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine and Public Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Yun', 'Affiliation': 'Department of Preventive Medicine and Public Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Seok Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Health & Nutrition R&D Group, Maeil Dairies Co., Ltd., Pyeongtaek-si 17714, Korea.'}, {'ForeName': 'Hyoung Su', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Health & Nutrition R&D Group, Maeil Dairies Co., Ltd., Pyeongtaek-si 17714, Korea.'}, {'ForeName': 'Yoon-Sok', 'Initials': 'YS', 'LastName': 'Chung', 'Affiliation': 'Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Yoo Kyoung', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yong-in 17104, Korea.'}]",Nutrients,['10.3390/nu12061816']
1841,32570855,"Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy.","This study evaluated the effect of action observation training on spasticity, gross motor function, and balance in children with spastic diplegia cerebral palsy. Eighteen children with cerebral palsy participated in this study. The participants were randomized into the action observation training group ( n  = 9) and a control group ( n  = 9). The action observation training group repeatedly practiced the action with their motor skills, while the control group practiced conventional physical therapy. Both groups received 30 min sessions, 3 days a week, for 6 weeks. To confirm the effects of intervention, the spasticity, gross motor function measurement (GMFM), and pediatric reaching test (PRT) were evaluated. The results showed that in the plantar flexor contracture test of both sides, the Modified Tardieu Scale (MTS) of the right side of knee joints, GMFM-B, C, and D were significantly increased between pre- and post-intervention within both groups ( p <  0.05). PRT was significantly increased between pre- and post-intervention within the both groups ( p <  0.05), and there was a significant difference between the two groups ( p <  0.05). These results suggest that action observation training is both feasible and beneficial for improving spasticity, gross motor function, and balance in children with spastic diplegia cerebral palsy.",2020,"PRT was significantly increased between pre- and post-intervention within the both groups ( p <  0.05), and there was a significant difference between the two groups ( p <  0.05).","['Children with Diplegia Cerebral Palsy', 'Eighteen children with cerebral palsy', 'children with spastic diplegia cerebral palsy']","['action observation training', 'Action Observation Training', 'control group practiced conventional physical therapy']","['PRT', 'plantar flexor contracture test of both sides, the Modified Tardieu Scale (MTS) of the right side of knee joints, GMFM-B, C, and D', 'Spasticity, Gross Motor Function, and Balance', 'spasticity, gross motor function measurement (GMFM), and pediatric reaching test (PRT', 'spasticity, gross motor function, and balance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0154701', 'cui_str': 'Diplegia of upper limbs'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0270804', 'cui_str': 'Diplegic cerebral palsy'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0020687', 'cui_str': 'Hypoxanthine phosphoribosyltransferase'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",18.0,0.0103191,"PRT was significantly increased between pre- and post-intervention within the both groups ( p <  0.05), and there was a significant difference between the two groups ( p <  0.05).","[{'ForeName': 'Young-A', 'Initials': 'YA', 'LastName': 'Jeong', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, 01795 Seoul, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, 01795 Seoul, Korea.'}]","Children (Basel, Switzerland)",['10.3390/children7060064']
1842,32575480,"Pain Bloc-R Alleviates Unresolved, Non-Pathological Aches and Discomfort in Healthy Adults-A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.","The lack of effective treatment for chronic discomfort without negative side effects highlights the need for alternative treatments. Pain Bloc-R is a natural health product composed of vitamins B 6 , B 12 , D, white willow bark extract, Angelica root extract, acetyl L-carnitine HCl, caffeine, L-theanine, Benfotiamine, and L-tetrahydropalmatine. The objective of this study was to compare the effects of Pain Bloc-R, acetaminophen, and placebo on unresolved aches and discomfort as assessed by the brief pain inventory (BPI) and modified Cornell musculoskeletal discomfort questionnaires. This randomized, double-blind, placebo-controlled, crossover study consisted of three 7-day periods with Pain Bloc-R, acetaminophen, or placebo, each separated by a 7-day washout. Twenty-seven healthy adults (ages 22-63 years) were randomized to receive the three interventions in different sequences. The BPI ""pain at its worst"" scores were significantly lower when participants took Pain Bloc-R than when they took acetaminophen (21.8% vs. 9.8% decrease,  p  = 0.026) after seven days of supplementation. Pain Bloc-R achieved a significant improvement in the ""pain at its least"" score, significantly decreased the interference of discomfort in walking, and significantly decreased musculoskeletal discomfort total scores (34%,  p  = 0.040) after seven days. In a  post hoc  subgroup analysis based on age and gender, male participants ≤45 years taking Pain Bloc-R reported significant reductions in pain severity and pain interference vs. acetaminophen. Pain Bloc-R performed as well as acetaminophen in managing unresolved non-pathological pain in otherwise healthy individuals.",2020,Pain Bloc-R performed as well as acetaminophen in managing unresolved non-pathological pain in otherwise healthy individuals.,"['otherwise healthy individuals', 'Healthy Adults', 'Twenty-seven healthy adults (ages 22-63 years']","['Pain Bloc-R, acetaminophen, and placebo', 'Placebo', 'Pain Bloc-R, acetaminophen, or placebo', 'acetaminophen', 'placebo']","['Pain Bloc-R', 'brief pain inventory (BPI) and modified Cornell musculoskeletal discomfort questionnaires', 'interference of discomfort in walking', 'BPI ""pain', 'pain severity and pain interference vs. acetaminophen', 'pain', 'musculoskeletal discomfort total scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",27.0,0.501716,Pain Bloc-R performed as well as acetaminophen in managing unresolved non-pathological pain in otherwise healthy individuals.,"[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'Abdul M', 'Initials': 'AM', 'LastName': 'Sulley', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Crowley', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Langston', 'Affiliation': 'LifeSeasons, Inc., Springville, UT 84663, USA.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Guthrie', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}]",Nutrients,['10.3390/nu12061831']
1843,32575605,Palatable Noodles as a Functional Staple Food Made Exclusively from Yellow Peas Suppressed Rapid Postprandial Glucose Increase.,"Legumes are low-carbohydrate food and are abundant in dietary fiber. In order to provide a functional staple food that does not cause a rapid increase in postprandial blood glucose levels, four kinds of legumes were focused on as ingredients. Noodles made from dehulled yellow pea, unshelled yellow pea, chickpea, and lentil were prepared and evaluated as functional staple foods for controlling blood glucose via an in vitro digestion method. We also measured breaking stress and breaking strain using a creep meter, as well as sensory tests on a 9-point hedonic scale. The noodles made from yellow pea had high values for both breaking stress and breaking strain, and was highly regarded in the sensory tests. Therefore, the noodles made from yellow pea on postprandial glucose and insulin response were measured in a randomized double-blind study ( n  = 12). The results show that noodles made from yellow pea have a low glycemic index (50.4), and have potential as a functional staple food.",2020,"The noodles made from yellow pea had high values for both breaking stress and breaking strain, and was highly regarded in the sensory tests.",[],[],"['postprandial blood glucose levels', 'postprandial glucose and insulin response']",[],[],"[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.0287479,"The noodles made from yellow pea had high values for both breaking stress and breaking strain, and was highly regarded in the sensory tests.","[{'ForeName': 'Joto', 'Initials': 'J', 'LastName': 'Yoshimoto', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Ban', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Mikiya', 'Initials': 'M', 'LastName': 'Kishi', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Humitoshi', 'Initials': 'H', 'LastName': 'Horie', 'Affiliation': 'Public Interest Incorporated Foundation Aiseikai Aisei Hospital Ueno Clinic, 2-18-6, Higashi-Ueno, Taito-Ku, Tokyo 100-0015, Japan.'}, {'ForeName': 'Chizumi', 'Initials': 'C', 'LastName': 'Yamada', 'Affiliation': 'Department of Clinical Health Science, Tokai University School of Medicine Tokai University Tokyo Hospital, 1-2-5 Yoyogi, Shibuya-ku, Tokyo 153-0065, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishizaki', 'Affiliation': 'Department of Clinical Health Science, Tokai University School of Medicine Tokai University Tokyo Hospital, 1-2-5 Yoyogi, Shibuya-ku, Tokyo 153-0065, Japan.'}]",Nutrients,['10.3390/nu12061839']
1844,32575660,"Parent Stress as a Consideration in Childhood Obesity Prevention: Results from the Guelph Family Health Study, a Pilot Randomized Controlled Trial.","Parents' stress is independently associated with increased child adiposity, but parents' stress may also interfere with childhood obesity prevention programs. The disruptions to the family dynamic caused by participating in a behaviour change intervention may exacerbate parent stress and undermine overall intervention efficacy. This study explored how family stress levels were impacted by participation in a home-based obesity prevention intervention. Data were collected from 77 families (56 fathers, 77 mothers) participating in the Guelph Family Health Study (GFHS), a pilot randomized control trial of a home-based obesity prevention intervention. Four measures of stress were investigated: general life stress, parenting distress, depressive symptoms, and household chaos. Multiple linear regression was used to compare the level of stress between the intervention and control groups at post-intervention and 1-year follow-up, adjusted for baseline stress. Analyses for mothers and fathers were stratified, except for household chaos which was measured at the family level. Results indicate no significant differences between intervention and control groups for any stress measure at any time point, indicating a neutral effect of the GFHS intervention on family stress. Future work should investigate the components of family-based intervention protocols that make participation minimally burdensome and consider embedding specific stress-reduction messaging to promote family health and wellbeing.",2020,"Results indicate no significant differences between intervention and control groups for any stress measure at any time point, indicating a neutral effect of the GFHS intervention on family stress.","['77 families (56 fathers, 77 mothers) participating in the Guelph Family Health Study (GFHS', 'mothers and fathers']","['home-based obesity prevention intervention', 'GFHS intervention']","['general life stress, parenting distress, depressive symptoms, and household chaos', 'child adiposity']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",77.0,0.0183439,"Results indicate no significant differences between intervention and control groups for any stress measure at any time point, indicating a neutral effect of the GFHS intervention on family stress.","[{'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hruska', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON N1G2W1, Canada.'}, {'ForeName': 'Gerarda', 'Initials': 'G', 'LastName': 'Darlington', 'Affiliation': 'Department of Mathematics and Statistics, University of Guelph, Guelph, ON N1G2W1, Canada.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Haines', 'Affiliation': 'Department of Family Relations and Applied Nutrition, University of Guelph, Guelph, ON N1G2W1, Canada.'}, {'ForeName': 'David W L', 'Initials': 'DWL', 'LastName': 'Ma', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON N1G2W1, Canada.'}]",Nutrients,['10.3390/nu12061835']
1845,32446323,Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials.,"BACKGROUND


Three drug classes (mineralocorticoid receptor antagonists [MRAs], angiotensin receptor-neprilysin inhibitors [ARNIs], and sodium/glucose cotransporter 2 [SGLT2] inhibitors) reduce mortality in patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers. Each class was previously studied with different background therapies and the expected treatment benefits with their combined use are not known. Here, we used data from three previously reported randomised controlled trials to estimate lifetime gains in event-free survival and overall survival with comprehensive therapy versus conventional therapy in patients with chronic HFrEF.
METHODS


In this cross-trial analysis, we estimated treatment effects of comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker) in patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744). Our primary endpoint was a composite of cardiovascular death or first hospital admission for heart failure; we also assessed these endpoints individually and assessed all-cause mortality. Assuming these relative treatment effects are consistent over time, we then projected incremental long-term gains in event-free survival and overall survival with comprehensive disease-modifying therapy in the control group of the EMPHASIS-HF trial (ACE inhibitor or ARB and β blocker).
FINDINGS


The hazard ratio (HR) for the imputed aggregate treatment effects of comprehensive disease-modifying therapy versus conventional therapy on the primary endpoint of cardiovascular death or hospital admission for heart failure was 0·38 (95% CI 0·30-0·47). HRs were also favourable for cardiovascular death alone (HR 0·50 [95% CI 0·37-0·67]), hospital admission for heart failure alone (0·32 [0·24-0·43]), and all-cause mortality (0·53 [0·40-0·70]). Treatment with comprehensive disease-modifying pharmacological therapy was estimated to afford 2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy.
INTERPRETATION


Among patients with HFrEF, the anticipated aggregate treatment effects of early comprehensive disease-modifying pharmacological therapy are substantial and support the combination use of an ARNI, β blocker, MRA, and SGLT2 inhibitor as a new therapeutic standard.
FUNDING


None.",2020,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"['patients with heart failure with reduced ejection fraction (HFrEF) beyond conventional therapy consisting of', '2·7 additional years (for an 80-year-old) to 8·3 additional years (for a 55-year-old) free from cardiovascular death or first hospital admission for heart failure and 1·4 additional years (for an 80-year-old) to 6·3 additional years (for a 55-year-old) of survival compared with conventional therapy', 'patients with HFrEF', 'patients with heart failure with reduced ejection fraction', 'patients with chronic HFrEF.\nMETHODS', 'patients with chronic HFrEF by making indirect comparisons of three pivotal trials, EMPHASIS-HF (n=2737), PARADIGM-HF (n=8399), and DAPA-HF (n=4744']","['comprehensive disease-modifying pharmacological therapy', 'angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and β blockers', 'comprehensive disease-modifying pharmacological therapies', 'comprehensive therapy versus conventional therapy', 'comprehensive disease-modifying pharmacological therapy (ARNI, β blocker, MRA, and SGLT2 inhibitor) versus conventional therapy (ACE inhibitor or ARB and β blocker']","['cardiovascular death or hospital admission for heart failure', 'hospital admission for heart failure alone (0·32', 'hazard ratio (HR', 'composite of cardiovascular death or first hospital admission for heart failure', 'cardiovascular death alone (HR 0·50 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.181843,HRs were also favourable for cardiovascular death alone (HR 0·50 [,"[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Pedro Ferreira', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France; Department of Physiology and Cardiothoracic Surgery, University of Porto, Porto, Portugal.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA; Imperial College, London, UK.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine, University of California, Los Angeles Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: ssolomon@bwh.harvard.edu.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)30748-0']
1846,32448782,Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis.,"OBJECTIVES


To report the 10-year outcome of lupus nephritis (LN) treated with mycophenolate mofetil (MMF) or tacrolimus (TAC) induction in a randomised controlled trial.
METHODS


Patients with active LN were treated with MMF or TAC combined with high-dose prednisolone. Responders were switched to azathioprine (AZA) at month 6. Clinical outcomes at 10 years (renal flares, renal function decline and mortality) were assessed. Factors affecting prognosis were studied by Cox regression. Urine protein-to-creatinine ratio (uPCr) and estimated glomerular filtration rate (eGFR) at different time points were evaluated for their prediction of a poor prognosis by receiver operating characteristic (ROC) analysis.
RESULTS


150 patients were studied (age 35.5±12.8 years). Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71). AZA maintenance was given to 79% patients. After 118.2±42 months, proteinuric and nephritic renal flares occurred in 34% and 37% of the MMF, and 53% and 30% of the TAC groups of patients, respectively (p=0.49). The cumulative incidence of a composite outcome of ↓eGFR ≥30%, chronic kidney disease stage 4/5 or death at 10 years was 33% in both groups (p=0.90). Factors independently associated with a poor renal prognosis were first-time LN (HR 0.12 (0.031 to 0.39); p=0.01), eGFR (HR 0.98 (0.96 to 0.99); p=0.008) and no response at month 6 (HR 5.18 (1.40 to 19.1); p=0.01). ROC analysis revealed an uPCr >0.75 and eGFR of <80 mL/min at month 18 best predicted a poor renal prognosis.
CONCLUSIONS


Long-term data confirmed non-inferiority of TAC to MMF as induction therapy of LN. An uPCr≤0.75 and eGFR of ≥80 mL/min at month 18 best predicted a favourable 10-year outcome and may be suitable targets for induction/consolidation therapy.
TRIAL REGISTRATION NUMBER


NCT00371319.",2020,Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71).,"['150 patients were studied (age 35.5±12.8\u2009years', 'Patients with active LN', 'active lupus nephritis']","['azathioprine (AZA', 'AZA maintenance', 'MMF or TAC combined with high-dose prednisolone', 'tacrolimus with mycophenolate mofetil', 'mycophenolate mofetil (MMF) or tacrolimus (TAC']","['chronic kidney disease stage 4/5 or death', 'Clinical outcomes at 10 years (renal flares, renal function decline and mortality', 'Urine protein-to-creatinine ratio (uPCr) and estimated glomerular filtration rate (eGFR', 'eGFR', 'Complete renal response rate', 'proteinuric and nephritic renal flares', 'poor renal prognosis']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",150.0,0.119119,Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71).,"[{'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong ccmok2005@yahoo.com.'}, {'ForeName': 'Ling Yin', 'Initials': 'LY', 'LastName': 'Ho', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Shirley King Yee', 'Initials': 'SKY', 'LastName': 'Ying', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong, China.'}, {'ForeName': 'Man Chi', 'Initials': 'MC', 'LastName': 'Leung', 'Affiliation': 'Medicine, United Christian Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Hung', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Woon Leung', 'Initials': 'WL', 'LastName': 'Ng', 'Affiliation': 'Medicine, United Christian Hospital, Hong Kong, Hong Kong.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217178']
1847,32449942,Effects of Prazosin on Provoked Alcohol Craving and Autonomic and Neuroendocrine Response to Stress in Alcohol Use Disorder.,"BACKGROUND


Chronic alcohol use results in changes to stress biology and autonomic arousal contributing to acute alcohol withdrawal symptoms, neuroendocrine tolerance of the hypothalamic-pituitary-adrenal axis responses, high stress-induced craving, and risk of alcohol relapse. Thus, stress coping and recovery from alcohol during early abstinence may be jeopardized by such stress system dysfunction. Significant preclinical evidence suggests that noradrenergic disruption may contribute to these alcohol-related stress arousal changes and that alpha-1 adrenergic antagonists, such as prazosin, may normalize these stress system adaptations and reduce alcohol intake. Thus, we hypothesized that prazosin would reduce stress-induced craving and improve neuroendocrine and autonomic response to stress and alcohol cue exposure during early abstinence. We secondarily also assessed the role of lifetime anxiety disorders on these prazosin effects.
METHODS


Forty inpatient treatment-seeking alcohol-dependent individuals were randomly assigned to receive placebo (n = 18) or 16 mg/d, T.I.D., prazosin (n = 22) in a double-blind manner, titrated over 2 weeks. In weeks 3 to 4 after achieving full dose, patients were exposed to 3 5-minute personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue), on 3 consecutive days in a random, counterbalanced order. Alcohol craving, anxiety, heart rate, cortisol, and adrenocorticotropic hormone (ACTH) levels were assessed at baseline, following imagery and at repeated recovery timepoints.
RESULTS


Prazosin reduced stress cue-induced alcohol craving (p < 0.05) and stress- and alcohol cue-induced anxiety (p < 0.05) and increased heart rate responses in all imagery conditions (p < 0.05). Prazosin lowered basal cortisol and ACTH (p's < 0.05) and attenuated stress cue-induced rises in cortisol (p < 0.05) versus placebo. Finally, in those without lifetime anxiety disorder, the placebo group showed stress- and alcohol cue-induced increases in cortisol (p's < 0.05), while the prazosin group did not.
CONCLUSIONS


Prazosin may attenuate stress cue-induced alcohol craving and anxiety during early abstinence while improving adrenergic and stress system function, effects which are independent of a history of lifetime anxiety disorders.",2020,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.",['Forty inpatient treatment-seeking alcohol dependent individuals'],"['placebo', 'personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue', 'prazosin', 'Prazosin']","['stress cue-induced alcohol craving and anxiety', ""basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol"", 'stress cue-induced alcohol craving (p<.05) and stress- and alcohol cue-induced anxiety (p<.05); and increased heart rate responses', 'stress-induced craving and improve neuroendocrine and autonomic response', 'Alcohol craving, anxiety, heart rate, cortisol and ACTH levels', 'stress- and alcohol cue-induced increases in cortisol', 'Provoked Alcohol Craving and Autonomic and Neuroendocrine Response']","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.0290454,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.","[{'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, (GAA), Department of Psychiatry, Connecticut Mental Health Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Department of Psychiatry, (HCF), Stony Brook University School of Medicine, Stony Brook, New York.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14378']
1848,32559734,"Effects of low fructose diet on glycemic control, lipid profile and systemic inflammation in patients with type 2 diabetes: A single-blind randomized controlled trial.","BACKGROUND AND AIM


Type 2 diabetes is one of the global epidemic disorders, which causes many side effects on the body. Fructose is a lipogenic monosaccharide. Recent studies have reported the adverse effects of this carbohydrate on diabetes. This study aimed to evaluate the clinical efficacy of a low-fructose diet on the metabolic alterations in patients with type 2 diabetes.
METHODS


This study was a randomized, single-blind clinical trial on 50 patients with type 2 diabetes. Participants randomly allocated to two groups, to receive either diabetic-diet or diabetic-diet with low-fructose for 8-weeks. Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors were assessed at baseline and the end of the trial.
RESULTS


At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013). Statistical analysis showed that low-fructose diet compared to control group significantly declined fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP) (P = 0.015, P = 0.001, P=<0.0001, P= <0.0001 and P= <0.0001 respectively).
CONCLUSION


Our results showed that eight weeks of low-fructose diet results in a significant improvement in FBG, HbA1c, TG, HDL-C and hs-CRP in patients with type 2 diabetes.",2020,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","['50 patients with type 2 diabetes', 'patients with type 2 diabetes']","['diabetic-diet or diabetic-diet with low-fructose for 8-weeks', 'low-fructose diet', 'Fructose', 'low fructose diet']","['fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP', 'Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors', 'glycemic control, lipid profile and systemic inflammation', 'body weight, waist circumference, and blood pressure', 'metabolic alterations', 'FBG, HbA1c, TG, HDL-C and hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452314', 'cui_str': 'Low fructose diet'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",50.0,0.074236,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Jalilvand', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran. Electronic address: golbonsohrab@yahoo.com.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.003']
1849,32559735,Improving clinical outcomes of diabetic foot ulcers by the 3-month self- and family management support programs in Indonesia: A randomized controlled trial study.,"BACKGROUND AND AIMS


Diabetic foot ulcers are the leading cause of lower extremity amputations, which require more effective prevention. Even though previous nursing studies on diabetic foot ulcers have been well performed, programs implementing self- and family management are limited and even underexplored. Therefore, the purpose of the study was to investigate the effect of 3-month self- and family management support programs on clinical outcomes among Indonesians with diabetic foot ulcers.
METHOD


The randomized controlled trial design was used to answer the research question of the study. A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group. The experimental group received self- and family management support programs for three months. Meanwhile, the control group received usual care. Descriptive statistics, multivariate analysis of variance, and Generalized Estimating Equations were used to analyze the data. The significance level was considered at .05 for hypothesis testing.
RESULTS


The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
CONCLUSIONS


With regard to the result of the study, implementing the 3-month self- and family management support programs improves the patients' and families' abilities to perform diabetic foot ulcer care at home.",2020,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","['A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group', 'Indonesia', 'Indonesians with diabetic foot ulcers']","['usual care', 'self- and family management support programs']","['self-management, family supports, hemoglobin A1c, and wound size']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",56.0,0.0239313,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","[{'ForeName': 'Sumarno Adi', 'Initials': 'SA', 'LastName': 'Subrata', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand; Department of Nursing and Wound Research Center, Faculty of Health Sciences, Universitas Muhammadiyah Magelang, Indonesia.'}, {'ForeName': 'Rutja', 'Initials': 'R', 'LastName': 'Phuphaibul', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: ruja.phu@mahidol.ac.th.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grey', 'Affiliation': 'Yale University School of Nursing, United States.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Siripitayakunkit', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Noppawan', 'Initials': 'N', 'LastName': 'Piaseu', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.028']
1850,32560576,"Erratum: Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial;  Nutrients  2020,  12 , 1165.",The authors would like to correct an error in a recent published paper [...].,2020,The authors would like to correct an error in a recent published paper [...].,['Pregnant Women with Gestational Diabetes'],['Erratum: Dietary Intervention'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]",[],,0.178666,The authors would like to correct an error in a recent published paper [...].,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Kusinski', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Cambridge Universities NHS Foundation Trust, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Emanuella De Lucia', 'Initials': 'EL', 'LastName': 'Rolfe', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Rennie', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Linda M Oude', 'Initials': 'LMO', 'LastName': 'Griep', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Cellular Medicine, University of Newcastle, NE4 5PL, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}]",Nutrients,['10.3390/nu12061793']
1851,32561673,Ketamine Affects Prediction Errors about Statistical Regularities: A Computational Single-Trial Analysis of the Mismatch Negativity.,"The auditory mismatch negativity (MMN) is significantly reduced in schizophrenia. Notably, a similar MMN reduction can be achieved with NMDA receptor (NMDAR) antagonists. Both phenomena have been interpreted as reflecting an impairment of predictive coding or, more generally, the ""Bayesian brain"" notion that the brain continuously updates a hierarchical model to infer the causes of its sensory inputs. Specifically, neurobiological interpretations of predictive coding view perceptual inference as an NMDAR-dependent process of minimizing hierarchical precision-weighted prediction errors (PEs), and disturbances of this putative process play a key role in hierarchical Bayesian theories of schizophrenia. Here, we provide empirical evidence for this theory, demonstrating the existence of multiple, hierarchically related PEs in a ""roving MMN"" paradigm. We applied a hierarchical Bayesian model to single-trial EEG data from healthy human volunteers of either sex who received the NMDAR antagonist S-ketamine in a placebo-controlled, double-blind, within-subject fashion. Using an unrestricted analysis of the entire time-sensor space, our trial-by-trial analysis indicated that low-level PEs (about stimulus transitions) are expressed early (102-207 ms poststimulus), while high-level PEs (about transition probability) are reflected by later components (152-199 and 215-277 ms) of single-trial responses. Furthermore, we find that ketamine significantly diminished the expression of high-level PE responses, implying that NMDAR antagonism disrupts the inference on abstract statistical regularities. Our findings suggest that NMDAR dysfunction impairs hierarchical Bayesian inference about the world's statistical structure. Beyond the relevance of this finding for schizophrenia, our results illustrate the potential of computational single-trial analyses for assessing potential pathophysiological mechanisms.",2020,The auditory mismatch negativity (MMN) is significantly reduced in schizophrenia.,"['healthy human volunteers of either sex who received the', 'healthy individuals']","['NMDAR antagonist S-ketamine', 'NMDA receptor antagonist ketamine', 'ketamine', 'Ketamine']","['auditory mismatch negativity (MMN', 'expression of high-level PE responses']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0856175,The auditory mismatch negativity (MMN) is significantly reduced in schizophrenia.,"[{'ForeName': 'Lilian A', 'Initials': 'LA', 'LastName': 'Weber', 'Affiliation': 'Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich and ETH Zurich, 8032 Zurich, Switzerland weber@biomed.ee.ethz.ch.'}, {'ForeName': 'Andreea O', 'Initials': 'AO', 'LastName': 'Diaconescu', 'Affiliation': 'Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich and ETH Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mathys', 'Affiliation': 'Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich and ETH Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry, University of Basel, 4001 Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropharmacology and Brain Imaging, University Hospital of Psychiatry, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropharmacology and Brain Imaging, University Hospital of Psychiatry, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Klaas E', 'Initials': 'KE', 'LastName': 'Stephan', 'Affiliation': 'Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich and ETH Zurich, 8032 Zurich, Switzerland.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3069-19.2020']
1852,32562716,Antimicrobial stewardship intervention to reduce unnecessary antibiotic doses in neonates.,The wording of the antibiotic duration orders for neonatal sepsis was changed as an antimicrobial stewardship initiative to reduce the administration of unnecessary antibiotic doses. The change in wording allowed the patient to stop receiving antibiotics after they received 48 hours of therapy if the health care team had not received notification of a positive culture. This initiative led to a decrease in the number of neonates that received extra unnecessary doses from 50% to 7.2%.,2020,This initiative led to a decrease in the number of neonates that received extra unnecessary doses from 50% to 7.2%.,['Neonates'],['Antimicrobial Stewardship Intervention'],[],"[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.106856,This initiative led to a decrease in the number of neonates that received extra unnecessary doses from 50% to 7.2%.,"[{'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Newby', 'Affiliation': 'Neonatal and Pediatric Pharmacy, Surrey Memorial Hospital, Surrey, Canada. Electronic address: Brandi.newby@fraserhealth.ca.'}, {'ForeName': 'Sandy H S', 'Initials': 'SHS', 'LastName': 'Mok', 'Affiliation': 'Neonatal and Pediatric Pharmacy, Surrey Memorial Hospital, Surrey, Canada.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neonatal and Pediatric Pharmacy, Surrey Memorial Hospital, Surrey, Canada.'}]",American journal of infection control,['10.1016/j.ajic.2020.06.177']
1853,32562747,Effects of an 8-week resistance training intervention on plantar flexor muscle quality and functional capacity in older women: A randomised controlled trial.,"The present study examined 8 weeks of resistance training and its effects on muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity in older women. Moreover, we tested if changes in muscle quality were associated with functional capacity. Twenty-four older women (66.3 ± 5.8 years; 69.0 ± 3.0 kg; 25.3 ± 1.4 kg·m -2 ) were recruited to the study. After completion of the baseline assessment, participants were randomly assigned to either the resistance training (RET, n = 12) or an active control group (CTR, n = 12). Muscle quality was evaluated through muscle echo intensity (MQ EI ) and specific tension (MQ ST ). Muscle thickness, unilateral plantar flexor muscle strength and functional tests were evaluated at baseline and after the training period. After 8 weeks, both MQ EI  and MQ ST  did not respond to the intervention. Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05). Finally, significant gains in muscle hypertrophy were observed in the RET group (P < 0.01), while muscle strength failed to change significantly (P > 0.05). In conclusion, a resistance training program provided significant benefits in the stair climb test, unrelated to plantar flexor-derived muscle quality measures as previously demonstrated in quadriceps femoris.",2020,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","['older women', 'Twenty-four older women (66.3\u202f±\u202f5.8\u202fyears; 69.0\u202f±\u202f3.0\u202fkg; 25.3\u202f±\u202f1.4\u202fkg·m -2 ']","['8-week resistance training intervention', 'resistance training (RET, n\u202f=\u202f12) or an active control', 'resistance training']","['stair climb performance', 'Muscle quality', 'plantar flexor-derived muscle quality', 'muscle quality', 'plantar flexor muscle quality and functional capacity', 'Muscle thickness, unilateral plantar flexor muscle strength and functional tests', 'muscle hypertrophy', 'muscle strength', 'muscle echo intensity (MQ EI ) and specific tension (MQ ST ', 'muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.0161992,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia. Electronic address: p.lopezda@our.ecu.edu.au.'}, {'ForeName': 'Brendan James', 'Initials': 'BJ', 'LastName': 'Crosby', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Bruna Patrícia', 'Initials': 'BP', 'LastName': 'Robetti', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Douglas Jean Preussler', 'Initials': 'DJP', 'LastName': 'Turella', 'Affiliation': 'Centro Clínico UCS, Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Thaís Andréia Schepa', 'Initials': 'TAS', 'LastName': 'Weber', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Morgana Lima', 'Initials': 'ML', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111003']
1854,32563539,"TEMPORARY REMOVAL: Quantification of changes in eyelid position in patients with dry eye syndrome: A randomized, placebo-controlled multicenter study of application of topical anesthetic.","The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.",2020,A trend towards increased baseline (pre-intervention) upper eyelid position in control patients was observed when compared to DES patients.,"['patients with dry eye syndrome', 'patients with dry eye syndrome (DES', 'patients with DES']","['topical anesthetic', 'topical placebo', 'Fluorescein', 'placebo']","['post-anesthetic palpebral fissure height', 'Mean MRD1', 'MRD1', 'MRD1 and palpebral fissure (PF) height', 'Upper eyelid marginal reflex distance (MRD1) and lower eyelid marginal reflex distance (MRD2', 'average MRD1 after anesthetic exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0423104', 'cui_str': 'Height of palpebral fissure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1969562', 'cui_str': 'Mental Retardation, Autosomal Dominant 1'}, {'cui': 'C0229244', 'cui_str': 'Structure of palpebral fissure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1828341', 'cui_str': 'Upper eyelid margin reflex distance'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C1827217', 'cui_str': 'Margin reflex distance'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.47251,A trend towards increased baseline (pre-intervention) upper eyelid position in control patients was observed when compared to DES patients.,"[{'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Greenberg', 'Affiliation': 'Department of Ophthalmology, Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Division of Ophthalmology, Cook County Health and Hospital Systems, Chicago, IL, USA.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Phelps', 'Affiliation': 'Division of Ophthalmology, NorthShore University HealthSystem, Evanston, IL, USA; Department of Ophthalmology and Visual Science, University of Chicago, Chicago, IL, USA. Electronic address: PPhelps@northshore.org.'}]",Disease-a-month : DM,['10.1016/j.disamonth.2020.101026']
1855,32564141,Ultrastructural changes of smooth and rough titanium implant surfaces induced by metal and plastic periodontal probes.,"OBJECTIVES


To determine the ultrastructural changes of titanium surfaces of dental implants induced by the tip of periodontal probes.
MATERIALS AND METHODS


A total of 40 samples of smooth and rough surfaces of titanium implants were randomly assigned for the treatment with metal or plastic periodontal probes under application angles of 20° and 60°. Titanium surfaces have been evaluated with CLSM prior and following to experimental probing determining various standardized 2D and 3D roughness parameters.
RESULTS


The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material. On smooth surfaces several amplitude roughness parameters were increased with metal probes but reached significance only for Rp (p = 0.007). Rough surface parts showed a slight but not significant reduction of roughness following to the contact with metal probes. The surface roughness remained almost unchanged on smooth and rough implant surfaces using plastic probes. The surface roughness on implant surfaces was not dependent on the application angle irrespective of the probe material.
CONCLUSION


Probing of titanium implants with metal probes and even less with plastic probes causes only minor changes of the surface roughness. The clinical significance of these changes remains to be elucidated.
CLINICAL RELEVANCE


Using plastic probes for the clinical evaluation of the peri-implant sulcus might avoid ultrastructural changes to titanium implant surfaces.",2020,The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material.,['A total of 40 samples of smooth and rough surfaces of titanium implants'],[],"['ultrastructural changes of titanium surfaces', 'average profile and surface roughness (Ra and Sa', 'surface roughness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0235481,The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material.,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Folwaczny', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany. mfolwa@dent.med.uni-muenchen.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Rudolf', 'Affiliation': 'ZEISS Microscopy Customer Center Europe, Carl Zeiss Microscopy GmbH, Oberkochen, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Frasheri', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany.'}, {'ForeName': 'Madlena', 'Initials': 'M', 'LastName': 'Betthäuser', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03341-1']
1856,32564438,"Regular Supplementation With Resveratrol Improves Bone Mineral Density in Postmenopausal Women: A Randomized, Placebo-Controlled Trial.","Resveratrol, a naturally occurring polyphenol in red grapes and berries, can act as a phytoestrogen. It has been shown to improve both systemic and cerebral circulatory functions, possibly through activation of endothelial estrogen receptors. in vitro and in vivo studies in rodent models also indicate a bone-protective role for resveratrol, particularly in ovariectomized rat models that mimic postmenopausal osteoporosis caused by estrogen deficiency. Hypothesizing a circulatory benefit of resveratrol in bone tissue, we investigated whether resveratrol supplementation could improve bone health in postmenopausal women. The Resveratrol for Healthy Aging in Women (RESHAW) trial was a 24-month randomized, double-blind, placebo-controlled, two-period crossover intervention conducted to evaluate the effects of resveratrol (75 mg twice daily) on cognition, cerebrovascular function, bone health, cardiometabolic markers, and well-being in postmenopausal women. After 12 months of supplementation with resveratrol versus placebo, there were positive effects on bone density in the lumbar spine (+0.016 ± 0.003 g/cm 2  ) and neck of femur (+0.005 ± 0.002 g/cm 2  ), which were accompanied by a 7.24% reduction in C-terminal telopeptide type-1 collagen levels, a bone resorption marker, compared with placebo. The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070 ± 0.018) and a reduction in the 10-year probability of major and hip fracture risk. The magnitude of improvement was higher in women with poor bone health biomarker status. Importantly, the improvement in femoral neck T-score with resveratrol correlated with improvement in perfusion. Our subanalysis also revealed that the bone-protective benefit of resveratrol was greater in participants who supplemented with vitamin D plus calcium. Regular supplementation with 75 mg of resveratrol twice daily has the potential to slow bone loss in the lumbar spine and femoral neck, common fracture sites in postmenopausal women without overt osteoporosis. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070±0.018) and a reduction in the 10-year probability of major and hip fracture risk.,"['postmenopausal women', 'women with poor bone health biomarker status', 'postmenopausal women without overt osteoporosis']","['resveratrol', 'placebo', 'vitamin D plus calcium', 'Regular supplementation with resveratrol', 'resveratrol supplementation']","['bone mineral density', 'bone density', 'femoral neck T-score', 'cognition, cerebrovascular function, bone health, cardiometabolic markers', 'bone health', '10-year probability of major and hip fracture risk']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.247533,The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070±0.018) and a reduction in the 10-year probability of major and hip fracture risk.,"[{'ForeName': 'Rachel Hx', 'Initials': 'RH', 'LastName': 'Wong', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Jay Jay', 'Initials': 'JJ', 'LastName': 'Thaung Zaw', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Cory J', 'Initials': 'CJ', 'LastName': 'Xian', 'Affiliation': 'UniSA Clinical & Health Sciences and Cancer Research Institute, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Peter Rc', 'Initials': 'PR', 'LastName': 'Howe', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4115']
1857,32570152,To study the changes in maternal hemodynamics with intravenous labetalol or nifedipine in acute severe hypertension.,"OBJECTIVE


To study the maternal hemodynamic changes in acute severe hypertension after treatment with intravenous labetalol or oral nifedipine using color doppler ultrasound.
STUDY DESIGN


We evaluated thirty pregnant women with gestational age between 28 and 40 weeks in acute severe hypertension (more than or equal to 160/105 mmHg) which were randomly allocated to receive either intravenous labetalol or oral nifedipine until blood pressure was lowered to less than or equal to 140/90 mmHg. Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery were measured baseline at the time of acute severe hypertension and repeated after control of blood pressure, to assess the changes in maternal hemodynamics if any with labetalol or nifedipine.
RESULTS


When evaluating right uterine artery Doppler parameters, a trend to increase in PI and RI was observed in those who received labetalol and nifedipine however the difference was not statistically significant. Whereas, while evaluating left uterine artery indices a trend to decrease PI was seen in nifedipine group but the difference was not statistically significant. On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
CONCLUSION


The use of labetalol and nifedipine were not related to any significant changes in maternal Doppler, which is reassuring about the safety of these drugs when treating acute severe hypertension in pregnancy.",2020,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","['thirty pregnant women with gestational age between 28 and 40\xa0weeks in acute severe hypertension (more than or equal to 160/105\xa0mmHg', 'acute severe hypertension', 'acute severe hypertension after treatment with intravenous']","['labetalol or nifedipine', 'nifedipine', 'labetalol or oral nifedipine', 'intravenous labetalol or oral nifedipine', 'labetalol and nifedipine', 'labetalol']","['renal artery indices', 'Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery', 'PI and RI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",30.0,0.0341283,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Department of Obstetrics & Gynaecology, YSPGMC, Nahan, India. Electronic address: thakurmonika126@gmail.com.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gainder', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Saha', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, PGIMER, Chandigarh, India.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.014']
1858,32570178,Effects of a 10-week multimodal dance and art intervention program leading to a public performance in persons with multiple sclerosis - A controlled pilot-trial.,"BACKGROUND


Dance therapy is increasingly reported in neurological diseases for improving several motor and cognitive functions, but was mostly studied in partner dance. No individual choreo-based dance program has ever been reported in MS.
OBJECTIVES


The aim of this pilot study is to investigate effects of a ten-week choreo-based dance intervention on different impairments in MS.
PARTICIPANTS


Seventeen participants with MS were allocated to a dance group (DG) or an art group (AG) for a ten-week intervention program, with a public live performance at the end of the intervention.
METHODS


The DG received choreo-based dance courses twice a week for 90 min, while the active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography. Measurements for fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place before and after the intervention. Differences were analysed with Wilcoxon Signed Rank test.
RESULTS


Both groups improved significantly on executive cognitive performance during dual task and fatigue. Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT). The AG showed significant improvements in on cognitive function (SDMT).
CONCLUSION


A ten-week multimodal dance intervention has positive effects on impact of fatigue, physical capacity and coordination, and cognitive performance during a dual task. Larger samples, follow-up measurements and research in different disability groups is recommended.",2020,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","['persons with multiple sclerosis', 'Seventeen participants with MS']","['active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography', 'ten-week choreo-based dance intervention', 'multimodal dance and art intervention program', 'dance group (DG) or an art group (AG']","['functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT', 'impact of fatigue, physical capacity and coordination, and cognitive performance', 'executive cognitive performance', 'fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place', 'cognitive function (SDMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",17.0,0.0172608,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Van Geel', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: fanny.vangeel@uhasselt.be.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Fit Up Neurological and Sport Physiotherapy, Antwerp, Belgium; Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Veldkamp', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: renee.veldkamp@uhasselt.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: peter.feys@uhasselt.be.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102256']
1859,32575945,[Therapeutic effects of target artery infusion of verapamil and chemotherapy drugs on advanced non-small cell lung cancer].,"Objective:  To investigate the effects of targeted artery perfusion of verapamil and chemotherapy drugs on advanced non-small cell lung cancer (NSCLC).  Methods:  Sixty patients with advanced NSCLC who were admitted to the Central Hospital of Zhumadian from April 2016 to April 2018 were selected as the research subjects. They were divided into the observation group (26 cases) and the control group (34 cases) according to the treatment method. Patients in the observation group were treated with targeted artery perfusion of verapamil and chemotherapy drugs while the control group were treated with target artery perfusion of chemotherapy drugs alone.Both groups were treated continuously for more than 2 months. The short-term curative effect, adverse reactions, changes in immune function, levels of serum tumor markers and Karnofsky Performance Scale (KPS) scores before and after treatment as well as the prognosis were compared between the two groups.  Results:  The response rate and control rate in the observation group were 80.8% and 96.2%, higher than 55.9% and 76.5% in the control group ( P <0.05). After treatment, CD4(+) levels and CD4(+) /CD8(+) in the observation group were (25.43±2.76)% and (0.88±0.11), lower than (27.56±2.79)% and (0.95±0.13) in the control group ( P <0.05). After treatment, serum levels of CEA and CA50 in the observation group were (11.57±2.32)ng/ml and (16.62±3.28)U/ml, also lower than (15.87±2.66)ng/ml and (20.31±3.42)U/ml in the control group ( P <0.05). There was no significant difference in adverse reactions between the two groups ( P >0.05). After treatment, KPS score of the observation group was (81.44±2.76) points, higher than (79.62±2.38) points of the control group ( P <0.05). The median survival time and progression-free median survival time of the observation group were 16.0 months and 7.5 months, respectively, significantly better than 10.0 months and 5.0 months of the control group ( P <0.05).  Conclusions:  The treatment with target arterial perfusion of verapamil and chemotherapy drugs for advanced NSCLC can effectively improve the short-term curative effect, reduce serum levels of tumor markers, improve life quality and prolong the survival time. However, it has a certain inhibitory effect on the patient's immune function.",2020,"After treatment, KPS score of the observation group was (81.44±2.76) points, higher than (79.62±2.38) points of the control group ( P <0.05).","['advanced non-small cell lung cancer', 'advanced non-small cell lung cancer (NSCLC', 'Sixty patients with advanced NSCLC who were admitted to the Central Hospital of Zhumadian from April 2016 to April 2018 were selected as the research subjects']","['CD8', 'target artery perfusion of chemotherapy drugs alone', 'verapamil', 'verapamil and chemotherapy drugs']","['KPS score', 'serum levels of CEA and CA50', 'survival time', 'short-term curative effect, adverse reactions, changes in immune function, levels of serum tumor markers and Karnofsky Performance Scale (KPS) scores', 'response rate and control rate', 'adverse reactions', 'life quality', 'median survival time and progression-free median survival time', 'CD4(+) levels and CD4']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}]","[{'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}]",60.0,0.0308044,"After treatment, KPS score of the observation group was (81.44±2.76) points, higher than (79.62±2.38) points of the control group ( P <0.05).","[{'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Tan', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Ma', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}]",Zhonghua zhong liu za zhi [Chinese journal of oncology],['10.3760/cma.j.cn112152-20190724-00461']
1860,32442195,Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials.,"BACKGROUND


DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle.
METHODS AND FINDINGS


The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p < 0.001) and B.CaseA V1V2 (GM 2314.0 versus 744.6, ratio = 3.11, 95% CI 1.51-6.38, p = 0.002). nAb response rates were >98% in both trials, with significantly higher 50% inhibitory dilution (ID50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects.
CONCLUSIONS


In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy.",2020,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","['Per-protocol cohorts included vaccine recipients from HVTN 100', 'southern Africa with harmonized trial designs', 'n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017']","['placebo', 'ALVAC priming', 'DNA plasmid versus canarypox virus (ALVAC']","['IgG bAb response rates', 'nAb response rates', 'Response rates to V1V2', 'binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96', 'bAb net mean fluorescence intensity (MFI', 'CD4+ T-cell response rates']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0211671', 'cui_str': 'ALVAC vaccine'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0282472', 'cui_str': 'Canarypox virus'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0019686', 'cui_str': 'AIDS Antigens'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.585483,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Maganga', 'Affiliation': 'NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Herce', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Naidoo', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'deCamp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Heptinstall', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Regensberg, Regensberg, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Swiss Vaccine Research Institute, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003117']
1861,32444457,Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial.,"OBJECTIVE


Type 2 diabetes is a leading cause of kidney failure, but few outcome trials proactively enrolled individuals with chronic kidney disease (CKD). We performed secondary analyses of cardiovascular (CV) and kidney outcomes across baseline estimated glomerular filtration rate (eGFR) categories (≥60, 45 to <60, 30 to <45, and <30 mL/min/1.73 m 2 ) in Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA), a cardiorenal placebo-controlled outcome trial of the dipeptidyl peptidase 4 inhibitor linagliptin (NCT01897532).
RESEARCH DESIGN AND METHODS


Participants with CV disease and/or CKD were included. The primary outcome was time to first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke (three-point major adverse CV event [3P-MACE]), with a secondary outcome of renal death, end-stage kidney disease, or sustained ≥40% decrease in eGFR from baseline. Other end points included progression of albuminuria, change in HbA 1c , and adverse events (AEs) including hypoglycemia.
RESULTS


A total of 6,979 subjects (mean age 65.9 years; eGFR 54.6 mL/min/1.73 m 2 ; 80.1% albuminuria) were followed for 2.2 years. Across eGFR categories, linagliptin as compared with placebo did not affect the risk for 3P-MACE (hazard ratio 1.02 [95% CI 0.89, 1.17]) or the secondary kidney outcome (1.04 [0.89, 1.22]) (interaction  P  values >0.05). Regardless of eGFR, albuminuria progression was reduced with linagliptin, as was HbA 1c , without increasing risk for hypoglycemia. AEs were balanced among groups overall and across eGFR categories.
CONCLUSIONS


Across all GFR categories, in participants with type 2 diabetes and CKD and/or CV disease, there was no difference in risk for linagliptin versus placebo on CV and kidney events. Significant reductions in risk for albuminuria progression and HbA 1c  and no difference in AEs were observed.",2020,"Across eGFR categories, linagliptin as compared with placebo did not affect the risk for 3P-MACE (hazard ratio 1.02 [95% CI 0.89, 1.17]) or the secondary kidney outcome (1.04 [0.89, 1.22]) (interaction  P  values >0.05).","['enrolled individuals with chronic kidney disease (CKD', '6,979 subjects (mean age 65.9 years; eGFR 54.6 mL/min/1.73 m 2 ; 80.1% albuminuria', 'People With Normal and Reduced Kidney Function', 'Participants with CV disease and/or CKD were included']","['placebo', 'Linagliptin', 'linagliptin']","['risk for 3P-MACE', 'time to first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke', 'cardiovascular (CV) and kidney outcomes across baseline estimated glomerular filtration rate (eGFR) categories', 'progression of albuminuria, change in HbA 1c , and adverse events (AEs) including hypoglycemia', 'eGFR, albuminuria progression', 'CV and kidney events', 'risk for albuminuria progression and HbA 1c  and no difference in AEs', 'Cardiovascular and Kidney Outcomes', 'secondary kidney outcome', 'renal death, end-stage kidney disease, or sustained ≥40% decrease in eGFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",6979.0,0.362961,"Across eGFR categories, linagliptin as compared with placebo did not affect the risk for 3P-MACE (hazard ratio 1.02 [95% CI 0.89, 1.17]) or the secondary kidney outcome (1.04 [0.89, 1.22]) (interaction  P  values >0.05).","[{'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia vlado.perkovic@unsw.edu.au.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'Kuratorium für Dialyse Kidney Centre, Munich, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Dallas, TX.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke Health, Durham, NC.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinicke', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0279']
1862,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION


Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.
METHODS


The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.
DISCUSSION


Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.
TRIAL REGISTRATION


This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067']
1863,32459129,Consolidation of Reward Memory during Sleep Does Not Require Dopaminergic Activation.,"Sleep enhances memories, especially if they are related to future rewards. Although dopamine has been shown to be a key determinant during reward learning, the role of dopaminergic neurotransmission for amplifying reward-related memories during sleep remains unclear. In this study, we scrutinize the idea that dopamine is needed for the preferential consolidation of rewarded information. We impaired dopaminergic neurotransmission, thereby aiming to wipe out preferential sleep-dependent consolidation of high- over low-rewarded memories during sleep. Following a double-blind, balanced, crossover design, 17 young healthy men received the dopamine d2-like receptor blocker sulpiride (800 mg) or placebo, after learning a motivated learning task. The task required participants to memorize 80 highly and 80 lowly rewarded pictures. Half of them were presented for a short (750 msec) and a long (1500 msec) duration, respectively, which permitted dissociation of the effects of reward on sleep-associated consolidation from those of mere encoding depth. Retrieval was tested after a retention interval of approximately 22 hr that included 8 hr of nocturnal sleep. As expected, at retrieval, highly rewarded memories were remembered better than lowly rewarded memories, under placebo. However, there was no evidence for an effect of reducing dopaminergic neurotransmission with sulpiride during sleep on this differential retention of rewarded information. This result indicates that dopaminergic activation likely is not required for the preferential consolidation of reward-associated memory. Rather, it appears that dopaminergic activation only tags such memories at encoding for intensified reprocessing during sleep.",2020,"As expected, at retrieval, highly rewarded memories were remembered better than lowly rewarded memories, under placebo.",['17 young healthy men'],"['dopamine d2-like receptor blocker sulpiride (800 mg) or placebo', 'dopamine', 'placebo']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],17.0,0.110276,"As expected, at retrieval, highly rewarded memories were remembered better than lowly rewarded memories, under placebo.","[{'ForeName': 'Marjan Alizadeh', 'Initials': 'MA', 'LastName': 'Asfestani', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Brechtmann', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Santiago', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Peter', 'Affiliation': 'German Center for Diabetes Research (DZD), Tübingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Born', 'Affiliation': 'University of Tübingen.'}, {'ForeName': 'Gordon Benedikt', 'Initials': 'GB', 'LastName': 'Feld', 'Affiliation': 'University of Tübingen.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01585']
1864,32567065,Effectiveness of the WeChat-based smoking cessation intervention ('WeChat WeQuit' program) in China: study protocol for a randomized controlled trial.,"BACKGROUND AND AIMS


Since its first release in 2011, WeChat (Chinese pinyin: Wei Xin) has been widely used to promote health. As the most popular all-in-one social media application providing free instant messaging, voice, text, pictures, videos and location information exchange via smartphone, WeChat holds promise for delivering smoking cessation services to a large number of people at low unit cost in China, a country with more than 300 million smokers. This protocol is for a study that aims to assess the efficacy of a WeChat-based smoking cessation intervention ('WeChat WeQuit') for treatment-seeking smokers in China.
DESIGN


In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of 'Happy Quit'. The intervention group will also receive the 2 weeks pre- and 12 weeks post-quit 'WeChat WeQuit' intervention. Both groups will be followed-up to 26 weeks (6 months) after quit day.
SETTING


This on-line trial has no restrictions on setting or location.
PARTICIPANTS


Chinese-speaking current smokers (have smoked ≥100 cigarettes in their life-time and currently smoke cigarettes) aged 18+ years willing to make a quit attempt within 1 month (n = 2000) will be recruited by on- and off-line advertising. Potential participants will register their interest by sending WeChat messages or text messages, or making a voice call.
MEASUREMENTS


The primary outcome measure is self-reported 26-week continuous smoking abstinence with biological verification [test by clinic visit: expired carbon monoxide concentration <10 parts per million (p.p.m.) or by mailing cotinine urine dipsticks: urine cotinine <200 ng/ml]. Secondary outcome measures include: 7-day point prevalence abstinence at weeks 1, 4, 8, 12, 16, 20 and 26 after-quit day; self-reported 12-week continuous smoking abstinence and 26-week continuous smoking abstinence; reductions in number of cigarettes smoked per day; and rates of participation in and completion of the smoking-cessation program.
CONCLUSIONS


If the 'WeChat WeQuit' program is found to be effective, it will be an accessible, affordable and widely implementable intervention to help cigarette smokers to quit. The potential public health impact of its expansion into underserved regions or communities is considerable.",2020,"In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of ""Happy Quit"".","['Chinese-speaking current smokers (smoked ≥ 100 cigarettes in the lifetime and currently smokes cigarettes) aged 18+, willing to make a quit attempt within 1 month (n = 2000) will be recruited by on-line and off-line advertising', 'treatment seeking smokers in China']","['WeChat-based smoking cessation intervention (""WeChat WeQuit', 'WeChat-based Smoking Cessation intervention (""WeChat WeQuit"" program']","[' 7-day point prevalence abstinence', 'continuous smoking abstinence and 26-week continuous smoking abstinence; reductions in number of cigarettes smoked per day; and rates of participation in and completion of smoking-cessation program', 'self-reported 26-week continuous smoking abstinence with biological verification (test by clinic visit: expired carbon monoxide concentration < 10 ppm or by mailing cotinine urine dipsticks: urine cotinine < 200 ng/ml']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",,0.0682711,"In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of ""Happy Quit"".","[{'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, Hangzhou, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yueheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, Hangzhou, China.'}]","Addiction (Abingdon, England)",['10.1111/add.15166']
1865,32568092,An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial.,"BACKGROUND


Although the most effective methods of contraception are available in Bolivia, unmet need for contraception among women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016). Mobile phones are a popular mode to deliver health behavior support. We developed a contraceptive behavioral intervention for young Bolivian women delivered by mobile phone and guided by behavioral science. The intervention consists of short instant messages sent through an app over 4 months.
OBJECTIVE


This trial aimed to evaluate the effect of the intervention on young Bolivian women's use of and attitudes toward the effective contraceptive methods available in Bolivia.
METHODS


This was a parallel group, individually randomized superiority trial with a 1:1 allocation ratio. Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish. The target sample size was 1310 participants. Participants allocated to the intervention had access to an app with standard family planning information and intervention messages. Participants allocated to the control group had access to the same app and control messages. Coprimary outcomes were use of effective contraception and acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion. Process outcomes included knowledge, perceived norms, personal agency, and intention. Outcomes were analyzed using logistic and linear regression. We also asked participants about physical violence.
RESULTS


A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception. There was no evidence that use differed between the groups (33% control vs 37% intervention; adjusted odds ratio [OR] 1.19, 95% CI 0.80 to 1.77; P=.40). There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06). There were no statistically significant differences in any of the secondary or process outcomes. The intervention dose received was low. In the control group, 2.8% (6/207) reported experiencing physical violence compared with 1.9% (4/202) in the intervention group (Fisher exact test P=.75).
CONCLUSIONS


This trial was unable to provide definitive conclusions regarding the effect of the intervention on use and acceptability of effective contraception because of under recruitment. Although we cannot strongly recommend implementation, the results suggest that it would be safe and may increase the acceptability of effective contraception if the intervention messages were offered alongside the download of the app.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526.",2020,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","['1310 participants', 'women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016', 'A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception', 'Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish', 'Young Women in Bolivia', ""young Bolivian women's"", 'young Bolivian women delivered by', 'participants about physical violence']","['intervention had access to an app with standard family planning information and intervention messages', 'control group had access to the same app and control messages', 'Mobile Phone Instant Messaging', 'mobile phone and guided by behavioral science', 'contraceptive behavioral intervention']","['acceptability', 'experiencing physical violence', 'acceptability of effective contraception', 'effective contraception and acceptability of at least one method of effective contraception', 'knowledge, perceived norms, personal agency, and intention', 'effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1277145', 'cui_str': 'Reads Spanish'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005918', 'cui_str': 'Bolivia'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004940', 'cui_str': 'Behavioral Sciences'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",640.0,0.278254,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","[{'ForeName': 'Ona L', 'Initials': 'OL', 'LastName': 'McCarthy', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Aliaga', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Torrico Palacios', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Jhonny', 'Initials': 'J', 'LastName': 'López Gallardo', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Huaynoca', 'Affiliation': 'International Planned Parenthood Federation/Western Hemisphere Region, New York, NY, United States.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Leurent', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Irrfan', 'Initials': 'I', 'LastName': 'Ahamed', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of medical Internet research,['10.2196/14073']
1866,32563863,DHA-enriched fish oil reduces insulin resistance in overweight and obese adults.,"Adipose tissue inflammation is major factor in the development of insulin resistance (IR). Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are anti-inflammatory bioactive lipids, thus may protect against type 2 diabetes (T2D) development. Previous research has demonstrated a sex-dependent association between LCn-3PUFA and T2D, and evidence suggests LCn-3PUFA may improve IR in a sex-dependent manner. This double-blind, randomized, parallel-arm placebo-controlled study aimed to determine whether DHA-enriched fish oil (FO) supplementation improves IR. Sex-dependent effects were assessed by testing for an interaction between sex and treatment in the multiple regression models. Men and women with abdominal obesity (waist circumference: males, ≥102 cm; females, ≥88 cm) and without diabetes were recruited from the community. Participants (age: 50.9 ± 12.7 years, female: 63.7%, BMI: 32.4 ± 6.6 kg/m 2 ) were randomly allocated to either 2 g FO (860 mg DHA + 120 mg EPA) (intervention, n = 38) or 2 g corn oil (CO) /day (control, n = 35) for 12 weeks in a double-blind randomised controlled trial. A fasting blood sample was collected at 0 and 12 weeks for assessment of IR, glucose and blood lipid profile. Sixty-eight participants completed the intervention. Compared with CO (n = 32), FO (n = 36) significantly reduced fasting insulin by -1.62 μIU/L (95%CI: -2.99, -0.26,) (p = 0.021) and HOMA-IR by -0.40 units (95%CI: -0.78, -0.02, p = 0.038). Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001). There was no interaction between sex and treatment for the change in insulin (p-interaction sex*treatment  = 0.816) or HOMA-IR (p-interaction sex*treatment  = 0.825). DHA-enriched FO reduces IR in adults with abdominal obesity, however, sex-dependent differences were not evident in this study.",2020,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"['overweight and obese adults', 'Participants (age: 50.9\xa0±\xa012.7 years, female: 63.7%, BMI: 32.4\xa0±\xa06.6\xa0kg/m 2 ', 'adults with abdominal obesity', 'Men and women with abdominal obesity (waist circumference: males, ≥102\xa0cm; females, ≥88\xa0cm) and without diabetes were recruited from the community']","['FO (860\xa0mg DHA\xa0+\xa0120\xa0mg EPA) (intervention, n\xa0=\xa038) or 2\xa0g corn oil (CO', 'μIU/L (95%CI', 'DHA-enriched FO', 'DHA-enriched fish oil (FO) supplementation', 'CO', 'Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'DHA-enriched fish oil', 'placebo']","['HOMA-IR', 'insulin resistance', 'IR, glucose and blood lipid profile', 'Higher insulin and HOMA-IR', 'fasting insulin']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",68.0,0.375942,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; School of Health Sciences, University of Newcastle, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'School of Public Health and Medicine, University of Newcastle, Australia; Department of Endocrinology and Diabetes, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: manohar.garg@newcastle.edu.au.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102154']
1867,32563939,Association of Meteorin-Like Hormone with insulin resistance and body composition in healthy Iranian adults.,"BACKGROUND AND AIMS


Sedentary behavior and/or physical inactivity are modifiable risk factors for noncommunicable diseases. Myokines are one of the mediators of physical activity health benefits. Relationship between regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl) has not been explored in human. Hence, we compared baseline plasma Metrnl between sedentary individuals and ones with recreational physical activities, and role of Metrnl as a biological messenger between physical activity and insulin resistance and body composition was also explored.
METHODS


Forty healthy young men (aged: 21 ± 2.1 yrs; BMI: 23 ± 3.44 kg/m 2 ) completed the study. Participants were equally assigned into two groups of control (sedentary) and case (recreational athletes). Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
RESULTS


Except for baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage were similar between two groups (P > 0.05). However, after Metrnl correction for the degree of insulin resistance index (Metrnl/HOMA-IR), recreational athletes showed a significantly greater baseline compared to sedentary subjects (P < 0.05). Baseline blood glucose showed a negative and significant correlation with baseline plasma Metrnl (P < 0.05).
CONCLUSIONS


Baseline plasma Metrnl is correlated with regular physical activity and insulin sensitivity, but not with body composition parameters. Metrnl may be one possible mediator of the beneficial effects of PA on insulin sensitivity in healthy humans. Hence, increasing awareness of the benefits of physical activity and incorporating physical activity into lifestyle are of great importance for people with non-communicable diseases.",2020,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","['healthy humans', 'Forty healthy young men (aged: 21\xa0±\xa02.1\xa0yrs', 'people with non-communicable diseases', 'healthy Iranian adults']","['Meteorin-Like Hormone with insulin resistance and body composition', 'regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl']","['Baseline blood glucose', 'degree of insulin resistance index (Metrnl/HOMA-IR', 'baseline plasma Metrnl', 'baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage', 'Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0269477,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sport Sciences, University of Mazandaran, Babolsar, Mazandaran, Iran. Electronic address: h.alizadeh.aw@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Sport Physiology, Faculty of Sport Sciences, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: aliakbar.alizadeh1984@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.031']
1868,32563960,Cost-effectiveness of preoperative magnetic resonance imaging to optimize surgery in ductal carcinoma in situ of the breast.,"PURPOSE


Complete surgical excision is the main factor for successful breast-conserving surgery in patients with ductal carcinoma in situ (DCIS) of the breast. Preoperative magnetic resonance imaging (MRI) may allow surgery optimization in this indication. From an economic standpoint, systematic preoperative MRI is associated with an extra cost, which may be offset by a decrease in the number of re-interventions. We performed an economic evaluation alongside IRCIS randomised controlled trial (NCT01112254) to determine whether systematic preoperative MRI in DCIS is a cost-effective strategy.
METHODS


360 patients were included in IRCIS trial. Costs were assessed from the French national health insurance perspective. Resource use was prospectively collected during a 6-month period after randomisation. We estimated the mean cost per averted re-intervention.
RESULTS


Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference: €298 [CI95% : -470; 1063]). There was a non-significant decrease in the rate of re-hospitalisations for positive or close margins (20% in MRI arm versus 27% in No MRI arm, difference -7% [CI95% : -17; 3]). At a willingness to pay of €500 to avert a re-intervention, the probability that MRI strategy is cost-effective was 93%.
CONCLUSION


Systematic preoperative MRI in patients with DCIS of the breast may be a cost-effective strategy. However, the modest clinical benefit associated with such a strategy limits the interest for this procedure in routine practice given the current MRI techniques.",2020,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","['360 patients were included in IRCIS trial', '€298', 'ductal carcinoma in situ of the breast', 'patients with ductal carcinoma in situ (DCIS) of the breast']","['Preoperative magnetic resonance imaging (MRI', 'preoperative magnetic resonance imaging']","['total costs', 'mean cost per averted re-intervention', 'rate of re-hospitalisations']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",360.0,0.132549,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","[{'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Kandel', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dunant', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Balleyguier', 'Affiliation': 'Gustave Roussy, Department of Medical Imaging, 114 rue Edouard Vaillant, Villejuif, F-94805, France. Electronic address: corinne.balleyguier@gustaveroussy.fr.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bonastre', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109058']
1869,32573767,Information on early medical abortion for women using an audiovisual animation versus face-to-face consultation: A consortium randomized and quasi-randomized trial.,"INTRODUCTION


There is some evidence that audiovisual formats can be an effective way of providing information about early medical abortion (EMA). A short animation (3 minutes) was developed about EMA in three languages that summarized the EMA process for use in the UK, France and Sweden.
MATERIAL AND METHODS


We conducted a multicenter randomized controlled trial to compare information on EMA delivered by an animated film versus a face-to-face consultation. Women requesting EMA (≤9 weeks' gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited. The primary outcome was women's recall of prespecified key information on EMA. Secondary outcomes were acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale. The study was prospectively registered with clinicaltrials.gov, ID number: NCT03417362.
RESULTS


172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48). There was no statistically significant difference in recall scores between the animation and standard arms in Edinburgh and Stockholm sites. However, the difference between arms at the Paris site was statistically significant (P = .007) in favor of the animation. All participants in the animation arm rated it as an acceptable way to receive information on EMA.
CONCLUSIONS


A ""short"" audiovisual animation can adequately and acceptably deliver key information about EMA. This intervention could be used routinely to provide standardized and high-quality information to women seeking EMA.",2020,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","['Women requesting EMA (<=9 weeks gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited', '172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48']",['audiovisual animation'],"['recall scores', ""women's recall of prespecified key information on EMA"", 'acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000789', 'cui_str': 'Abortion Clinics'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376650', 'cui_str': 'Animation'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",172.0,0.142109,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Reynolds-Wright', 'Affiliation': 'MRC Centre for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Belleuvre', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Daberius', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Faucher', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'MRC Centre for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13944']
1870,32573773,Finding a way in daily clinical practice during Covid-19 pandemic.,"Since some months, the Covid-19 pandemic changed our world drastically. At the start of the pandemic, in a single week, our medical communities, both in primary care , nursing homes, as in secondary and tertiary facilities have been forced to stop all regular clinical care and to shift towards hospital care that was ultimately restricted to Covid-19 related disease. The clinical presentation of Covid-19 occurred predominantly in the elderly patients (most > 65 years old) displaying a respiratory disability, and in a small proportion among them displayed a respiratory failure, in association with a broad range of pre-existing co-morbidities. Covid-19 had not been taught in university and to prepare ourselves, we aimed to retract data published from especially Chinese studies. Most literature was published without a peer-review procedure (fast track), and most intervention designs existed of small groups and a not blinded/not randomized inclusion. After an extensive week of patients' contact, we experienced various differences (compared to the prior reports) in their first presentation and in their individual course of disease.",2020,"At the start of the pandemic, in a single week, our medical communities, both in primary care , nursing homes, as in secondary and tertiary facilities have been forced to stop all regular clinical care and to shift towards hospital care that was ultimately restricted to Covid-19 related disease.",[],[],[],[],[],[],,0.0334595,"At the start of the pandemic, in a single week, our medical communities, both in primary care , nursing homes, as in secondary and tertiary facilities have been forced to stop all regular clinical care and to shift towards hospital care that was ultimately restricted to Covid-19 related disease.","[{'ForeName': 'Marcel B', 'Initials': 'MB', 'LastName': 'Twickler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolic Disease, AZ Monica, Antwerp, Belgium.'}, {'ForeName': 'Jakub J', 'Initials': 'JJ', 'LastName': 'Regieli', 'Affiliation': 'European Society of Clinical Investigation, Journal Foundation President, Utrecht, the Netherlands.'}]",European journal of clinical investigation,['10.1111/eci.13329']
1871,32569934,Metabolic tracking of isoflavones in soybean products and biosamples from healthy adults after fermented soybean consumption.,"Fermentation may enhance the nutritional properties of foods by increasing metabolite bioactivity or bioavailability. This study explored the effect of fermentation on isoflavone bioavailability and metabolism. Isoflavone metabolites were tracked in foods and biospecimens of healthy adults after fermented soybean (FS) or non-fermented soybean (NFS) consumption in a randomized, controlled, crossover intervention study. The change in soybean isoflavones caused by fermentation resulted in faster absorption and higher bioavailability after consumption of FS. Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis. This study suggests that an isoflavone conjugate profile might be a more appropriate marker than total isoflavone levels for discriminating between the consumption of FS and NFS diets.",2020,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","['healthy adults after', 'healthy adults after fermented soybean consumption']","['fermented soybean (FS) or non-fermented soybean (NFS) consumption', 'isoflavones', 'Isoflavone metabolites']","['faster absorption and higher bioavailability', 'urinary level of total isoflavone metabolites', 'metabolite bioactivity or bioavailability', 'isoflavone bioavailability and metabolism']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0552057,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","[{'ForeName': 'Hwan-Hee', 'Initials': 'HH', 'LastName': 'Jang', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea; Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heon-Woong', 'Initials': 'HW', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Su-Yeon', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Hyeon-Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Seon-Hye', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Sung-Hyen', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gunter', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ferrari', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Scalbert', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Freisling', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Jung-Bong', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Jeong-Sook', 'Initials': 'JS', 'LastName': 'Choe', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea. Electronic address: swany@korea.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea. Electronic address: orank@ewha.ac.kr.'}]",Food chemistry,['10.1016/j.foodchem.2020.127317']
1872,32570015,Lactobacillus rhamnosus GG and HbA1c in middle age and older adults without type 2 diabetes mellitus: A preliminary randomized study.,"BACKGROUND AND AIMS


Probiotic supplementation improves glycemic control in persons with diabetes and the current study examined whether these benefits extend to healthy individuals.
METHODS


The current study was a 90-day placebo-controlled, double-blind, randomized clinical trial of Lactobacillus rhamnosus GG in healthy middle-aged and older adults. Fasting blood glucose and HbA1c were quantified at baseline and follow up.
RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
CONCLUSIONS


If replicated, Lactobacillus rhamnosus GG may protect against changes in glycemic control.",2020,"RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
","['middle age and older adults without type 2 diabetes mellitus', 'healthy middle-aged and older adults', 'persons with diabetes']","['placebo', 'Lactobacillus rhamnosus GG', 'Lactobacillus rhamnosus GG and HbA1c', 'Probiotic supplementation']","['glycemic control', 'HbA1c values', 'Fasting blood glucose and HbA1c']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.163147,"RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
","[{'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Sanborn', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA. Electronic address: vsanborn@kent.edu.'}, {'ForeName': 'M Andrea', 'Initials': 'MA', 'LastName': 'Azcarate-Peril', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, and UNC Microbiome Core, Center for Gastrointestinal Biology and Disease, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gunstad', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA; Brain Health Research Institute, Kent State University, USA.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.034']
1873,32570059,"Effect of photobiomodulation on salivary flow and composition, xerostomia and quality of life of patients during head and neck radiotherapy in short term follow-up: A randomized controlled clinical trial.","Xerostomia and hyposalivation are frequent conditions in patients undergoing head and neck radiotherapy, which usually lead to a worsening of quality of life. This study aimed to assess whether photobiomodulation (PBM) can minimize hyposalivation, xerostomia and qualitative changes on saliva and improve quality of life in patients undergoing radiotherapy in short-term follow-up. Twenty-one patients were randomly divided into two groups: sham group (SG) and laser group (LG). A diode laser was used for intra- (660 nm, 10 J/cm 2 , 0.28 J per point, 40 mW) and extra-oral (810 nm, 25 J/cm 2 , 0.7 J per point, 40 mW) applications over the salivary glands, three times a week, during the entire radiotherapy period. In SG, the tip of the instrument was sealed with blue rubber to prevent the passage of light. Xerostomia and pH were evaluated and unstimulated and stimulated salivary flow was determined before the start of radiotherapy (T1), after the 15th session (T2), after the end of radiotherapy (T3) and 60 days after radiotherapy (T4). Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities were evaluated in stimulated saliva samples. Quality of life was assessed at times T1 and T4. Generalized estimating equations were used to assess differences in the outcome between times and groups. All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001). An increase in chloride concentrations was observed at times T3 and T4 (p < 0,05), and a reduction in amylase activity at T3 (p < .05). Unstimulated saliva pH was higher in LG than SG at T3 (p = .037). No difference between groups was noted in relation to salivary flow and composition, xerostomia or quality of life. Our results suggest that PBM may help in preserving salivary pH during radiotherapy.",2020,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","['patients undergoing head and neck', 'patients during head and neck radiotherapy in short term follow-up', 'patients undergoing radiotherapy in short-term follow-up', 'Twenty-one patients']","['radiotherapy', 'photobiomodulation (PBM', 'photobiomodulation', 'sham group (SG) and laser group (LG', 'diode laser', 'PBM']","['quality of life', 'Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities', 'Unstimulated saliva pH', 'relation to salivary flow and composition, xerostomia or quality of life', 'amylase activity', 'Quality of life', 'salivary flow and composition, xerostomia and quality of life', 'chloride concentrations', 'Xerostomia and pH', 'salivary flow, xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",21.0,0.0663906,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","[{'ForeName': 'Gabriel Campos', 'Initials': 'GC', 'LastName': 'Louzeiro', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cherubini', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Maria Antonia Zancanaro', 'Initials': 'MAZ', 'LastName': 'de Figueiredo', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fernanda Gonçalves', 'Initials': 'FG', 'LastName': 'Salum', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: fernanda.salum@pucrs.br.'}]","Journal of photochemistry and photobiology. B, Biology",['10.1016/j.jphotobiol.2020.111933']
1874,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND


Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated.
MATERIALS AND METHODS


We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C.
RESULTS


A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant).
CONCLUSIONS


There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012']
1875,32579773,Evaluation of safety and efficacy of autologous topical platelet gel vs platelet rich plasma injection in the treatment of venous leg ulcers: A randomized case control study.,"Various management options were tried for Chronic venous leg ulcers (VLUs) with no satisfactory results. Platelet-rich plasma (PRP) is promising in enhancing chronic wound healing by releasing various growth factors. We evaluated the safety and efficacy of topical platelet gel (PG) vs PRP injection in treatment of venous leg ulcers. 20 patients were treated with topical PG (group I), 20 patients received PRP injection (group II), and 20 patients were treated with saline dressing and compression as controls (group III) weekly for 6 weeks. Ulcer improvement was evaluated by pressure ulcer scale for healing (PUSH). Histopathological evaluation and immunohistochemical staining using anti-CD34 were performed before and after treatment. There was significant improvement in PUSH score in group (I) and (II) compared to group (III; P value: .001). However, there was no statistically significant difference in improvement between group I and II (P value = .83). However, topical PG was more effective in diabetics and PRP was more effective in long standing fibrosed ulcers. Histopathology showed reduction of the inflammatory cells infiltrates and well-formed granulation tissue with no difference in immunostaining. So, both topical PG and PRP injection were effective, low cost, and safe procedures in enhancing healing of chronic VLUs.",2020,There was significant improvement in PUSH score in group (I) and group (II) compared to group (III) (P-value:0.001).,"['venous leg ulcers', '20 patients', 'Venous Leg Ulcers']","['topical PG', 'Platelet-rich plasma (PRP', 'topical platelet gel (PG', 'Autologous Topical Platelet Gel versus Platelet Rich Plasma Injection', 'saline dressing and compression as controls', 'PRP injection']","['PUSH score', 'safety and efficacy', 'inflammatory cells infiltrates and well-formed granulation tissue', 'pressure ulcer scale for healing (PUSH']","[{'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C2721313', 'cui_str': 'Sodium chloride dressing'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}]",20.0,0.0109079,There was significant improvement in PUSH score in group (I) and group (II) compared to group (III) (P-value:0.001).,"[{'ForeName': 'Lamia Hamouda', 'Initials': 'LH', 'LastName': 'Elgarhy', 'Affiliation': 'Faculty of Medicine, Department of Dermatology and Venereology, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amal Ahmad', 'Initials': 'AA', 'LastName': 'El-Ashmawy', 'Affiliation': 'Faculty of Medicine, Department of Dermatology and Venereology, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Asmaa Elsayed', 'Initials': 'AE', 'LastName': 'Bedeer', 'Affiliation': 'Faculty of Medicine, Department of Dermatology and Venereology, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Aya Mohammed', 'Initials': 'AM', 'LastName': 'Al-Bahnasy', 'Affiliation': 'Faculty of Medicine, Department of Dermatology and Venereology, Tanta University, Tanta, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13897']
1876,32579779,Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery.,"BACKGROUND


The optimum cardiac surgical pain management has known to maintain hemodynamic stability and, reduces respiratory and cardiovascular complications. Postoperative parasternal intercostal block has shown to reduce postoperative analgesic consumption after cardiac surgery. Therefore, this study sought to investigate the effectiveness of the preoperative ultrasound guided parasternal block in reducing postoperative pain after cardiac surgery.
METHODS


This was a randomized, prospective, interventional, single blind study comprised of 90 adult patients scheduled for cardiac surgery involving sternotomy. Preoperatively and postoperatively, 0.25% bupivacaine administered in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under ultrasound guidance and direct vision, respectively. Postoperative pain was rated according to visual analogue scale. Secondary outcomes included intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation.
MAIN RESULTS


There was no significant differences in visual analogue score visual analogue score at all time points till 24 hours postoperatively. Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72; P = .0001). Furthermore, there were no significant difference in total fentanyl requirement (7.20 ± 2.66 vs 8.37 ± 3.13; P = .06) and tramadol requirement (0.02 ± 0.15 vs 0.07 ± 0.26; P = .28) within first 24 hours. However, time to extubation was significantly higher in the preoperative group (P = .02).
CONCLUSIONS


Preoperative and postoperative parasternal intercostal block provide comparable pain relief during the postoperative period.",2020,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"['90 adult patients scheduled for cardiac surgery involving sternotomy', 'cardiac surgery']","['preoperative ultrasound guided parasternal block', 'bupivacaine', 'preincisional and postincisional parasternal intercostal block']","['visual analogue score visual analogue score', 'Intraoperative fentanyl requirements', 'total fentanyl requirement', 'pain relief', 'time to extubation', 'postoperative pain', 'postoperative analgesic consumption', 'intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation', 'Postoperative pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442146', 'cui_str': 'Parasternal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",90.0,0.116657,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"[{'ForeName': 'Sri Rama Ananta Nagabhushanam', 'Initials': 'SRAN', 'LastName': 'Padala', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ashok Shankar', 'Initials': 'AS', 'LastName': 'Badhe', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Satyen', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]",Journal of cardiac surgery,['10.1111/jocs.14651']
1877,32442189,Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial.,"BACKGROUND


Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa.
METHODS AND FINDINGS


In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37-1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49-1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (-0.10 log10 copies/mL, 95% CI -0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08-24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24-0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47-0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months' outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection.
CONCLUSIONS


In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01721798.",2020,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","['women living with HIV in South Africa', 'Participant median age was 31 years, and 95% had 1 or more prior pregnancies', 'male partners', 'We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women', 'Cape Town, South Africa', 'eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART', 'Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent', 'Women living with HIV (WLHIV']","['Hormonal contraceptives', 'levonorgestrel intrauterine system', 'injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC', 'levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD']","['39 serious adverse events (SAEs); SAEs', 'gVL or pVL and had low levels of contraceptive failure and associated PID', 'Mean hemoglobin change', 'elective discontinuation', 'hemoglobin levels', 'pVL, RTI, and pregnancy testing', 'genital tract HIV viral load (gVL) and sexual transmission risk', 'mean pVL', 'gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation', 'expulsion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009866', 'cui_str': 'Contraception failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031406', 'cui_str': 'Phenindione'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}]",71.0,0.642316,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Todd', 'Affiliation': 'Maternal and Child Health and Nutrition Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, City University of New York School of Public Health, New York, New York, United States of America.'}, {'ForeName': 'Nontokozo', 'Initials': 'N', 'LastName': 'Langwenya', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Institute for Health Care Policy and Aging Research, Rutgers University, Piscataway, New Jersey, United States of America.'}, {'ForeName': 'Pai-Lien', 'Initials': 'PL', 'LastName': 'Chen', 'Affiliation': 'Global Population and Health Research Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Petro', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003110']
1878,32445228,T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial.,"In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) clinical trial (NCT01631214), 1 year of romosozumab followed by alendronate reduced the risk of vertebral and nonvertebral fractures compared to alendronate alone in women with prevalent fracture. We performed post hoc analyses of data from patients in ARCH (romosozumab, n = 1739; alendronate, n = 1726) who had a baseline BMD measurement and received at least one open-label alendronate dose. We evaluated 1-year mean BMD and corresponding T-score changes; proportions of patients achieving T-scores > -2.5 at the total hip (TH), femoral neck (FN), and lumbar spine (LS); and group differences in fracture rates after 12 months, while all participants were on alendronate. Subsequently, we investigated the relationship between T-scores achieved at the TH, FN, and LS at 12 months and subsequent fracture incidence. At 1 year, mean change from baseline in TH BMD was 6.3% (T-score change 0.31) with romosozumab versus 2.9% (T-score change 0.15) with alendronate (p < .001). The proportion of patients with TH T-score > -2.5 increased from 34% at baseline to 55% after 1 year of romosozumab and from 32% at baseline to 44% after 1 year of alendronate. Compared with patients receiving alendronate in year 1, those receiving romosozumab had a 75% reduction in new or worsening vertebral fracture (p < .001) in year 2, and a 19% reduction in nonvertebral fracture (p = .120) and 40% reduction in hip fracture (p = .041) during the open-label period. TH and FN T-scores achieved at month 12 were associated with subsequent nonvertebral and vertebral fracture rates and the relationships were independent of treatment received. LS T-score at 12 months was associated with vertebral but not nonvertebral fracture risk. We conclude that 1 year of romosozumab leads to larger BMD gains versus alendronate, and that the T-score achieved with either therapy is related to subsequent fracture risk. These data support the use of T-score as a therapeutic target for patients with osteoporosis. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,TH and FN T-scores achieved at month 12 were associated with subsequent nonvertebral and vertebral fracture rates and the relationships were independent of treatment received.,"['patients in ARCH (romosozumab, n =\u20091739; alendronate, n =\u20091726) who had a baseline BMD measurement and received at least one open-label alendronate dose', '2020', 'women with prevalent fracture', 'Postmenopausal Women With Osteoporosis at High Risk (ARCH', 'patients with osteoporosis']","['alendronate alone', 'Romosozumab or Alendronate', 'alendronate']","['LS T-score', 'fracture rates', 'new or worsening vertebral fracture', 'TH and FN T-scores', 'BMD gains', 'TH BMD', 'nonvertebral and vertebral fracture rates', 'proportion of patients with TH T-score', 'total hip (TH), femoral neck (FN), and lumbar spine (LS', 'hip fracture', 'nonvertebral fracture', 'Fracture Risk', '1-year mean BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}]","[{'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0761765,TH and FN T-scores achieved at month 12 were associated with subsequent nonvertebral and vertebral fracture rates and the relationships were independent of treatment received.,"[{'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hesse', 'Affiliation': 'Institute of Molecular Musculoskeletal Research, Faculty of Medicine, Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, University of Tokushima, Tokushima, Japan.'}, {'ForeName': 'Daria B', 'Initials': 'DB', 'LastName': 'Crittenden', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rojeski', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Service and Laboratory of Bone Diseases, Geneva University Hospital, Geneva, Switzerland.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3996']
1879,32448931,The disaster worker resiliency training program: a randomized clinical trial.,"OBJECTIVES


Disaster workers are at elevated risk for mental health problems as a result of trauma exposures during response efforts. One possible way to prevent mental health problems is to build-up coping resources that promote resilience to the effects of disaster work. The primary aim of this study was to evaluate the efficacy of a resilience building workshop, the Disaster Worker Resiliency Training Program (DWRT), in disaster workers previously exposed to Hurricane Sandy.
METHODS


Disaster workers (N = 167) were randomly assigned to the DWRT workshop (n = 78) or a waitlist (n = 89). Workers completed self-report measures on healthy lifestyle behaviors, perceived stress, depression, and Posttraumatic Stress Disorder (PTSD) symptoms at baseline and 3-month follow-up. They also completed a measure assessing subsequent trauma-exposure between the baseline and 3-month post-intervention.
RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02). Among participants reporting subsequent trauma exposures between T1 and T2  (n = 101), participants in the waitlist condition, were more likely to report significant increases in perceived stress (η 2  = .07, p < .01), PTSD (η 2  = .05, p = .03), and depression (η 2  = .07, p < .01) symptoms.
CONCLUSIONS


Participation in the resilience workshop promoted engagement in positive health behaviors and reduced the incidence of mental health symptoms, especially when administered prior to a repeat trauma exposure. Further research is needed to evaluate the long-term health effects of participation in the program.",2020,"RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02).","['Disaster workers (N\u2009=\u2009167', 'disaster workers previously exposed to Hurricane Sandy']","['DWRT workshop', 'resilience building workshop, the Disaster Worker Resiliency Training Program (DWRT']","['incidence of mental health symptoms', 'healthy lifestyle behaviors', 'stress management', 'positive health behaviors', 'spiritual growth', 'PTSD', 'healthy lifestyle behaviors, perceived stress, depression, and Posttraumatic Stress Disorder (PTSD) symptoms', 'depression', 'perceived stress']","[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020183', 'cui_str': 'Hurricane'}]","[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687002', 'cui_str': 'Spiritual growth'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",167.0,0.0234846,"RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02).","[{'ForeName': 'Brittain L', 'Initials': 'BL', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Stony Brook University School of Medicine, Putnam Hall-South Campus, Stony Brook, NY, 11794, USA. Brittain.Mahaffey@stonybrookmedicine.edu.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Mackin', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosen', 'Affiliation': 'National Clearinghouse for Worker Safety & Health Training, Washington, DC, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Schwartz', 'Affiliation': 'Center for Disaster Health Trauma, & Resilience at Stony Brook University, Mount Sinai, and Northwell Health, Great Neck, NY, USA.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Taioli', 'Affiliation': 'Center for Disaster Health Trauma, & Resilience at Stony Brook University, Mount Sinai, and Northwell Health, Great Neck, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Stony Brook University School of Medicine, Putnam Hall-South Campus, Stony Brook, NY, 11794, USA.'}]",International archives of occupational and environmental health,['10.1007/s00420-020-01552-3']
1880,32569560,Droperidol Reduces Postoperative Nausea and Vomiting and Supports the Continuation of Intravenous Patient-Controlled Analgesia with Fentanyl.,"PURPOSE


To examine the impact of adding droperidol to fentanyl-based intravenous patient- controlled analgesia (IVPCA) on the discontinuation of IVPCA use due to postoperative nausea and vomiting (PONV).
METHODS


Patients who underwent surgeries other than abdominal surgeries and used IVPCA between April 2014 and March 2018 were selected. Patients using IVPCA with fentanyl alone were compared to patients using droperidol added to IVPCA. Patients were allocated to one of two groups depending on the drug used for IVPCA: 1) control group, fentanyl alone; 2) droperidol group, droperidol with fentanyl. The primary endpoint was the discontinuation of IVPCA due to PONV. Secondary endpoints included PONV within 48 hours after surgery, the number of antiemetics used, pain score, and adverse effects. Propensity score matching was used to control the differences in clinical features among patients.
RESULTS


Among the 793 patients initially enrolled in this study, 145 were excluded via propensity score matching; 364 of the remaining patients received IVPCA supplemented with droperidol. Propensity score matching showed that discontinuation of IVPCA due to PONV was significantly decreased in the droperidol group compared to the control group (P = 0.01). Further, compared with the control group, the droperidol group had reduced nausea up to 24 hours after surgery (P < 0.01), and the number of vomiting episodes and use of antiemetics decreased within 12 hours after surgery (P < 0.01).
CONCLUSIONS


The addition of droperidol to IVPCA is associated with a decrease in PONV, as well as the improved continuation of pain treatment with fentanyl-based IVPCA, similar to IVPCA with morphine. However, it is necessary to monitor the side effects of this treatment.",2020,"Further, compared with the control group, the droperidol group had reduced nausea up to 24 hours after surgery (P < 0.01), and the number of vomiting episodes and use of antiemetics decreased within 12 hours after surgery (P < 0.01).
","['793 patients initially enrolled in this study, 145 were excluded via propensity score matching; 364 of the remaining patients received', 'Patients who underwent surgeries other than abdominal surgeries and used IVPCA between April 2014 and March 2018 were selected']","['Droperidol', 'Fentanyl', 'droperidol', 'IVPCA with fentanyl', 'droperidol to fentanyl-based intravenous patient- controlled analgesia (IVPCA', 'IVPCA', 'IVPCA supplemented with droperidol', 'IVPCA: 1) control group, fentanyl alone; 2) droperidol group, droperidol with fentanyl', 'morphine']","['PONV within 48 hours after surgery, the number of antiemetics used, pain score, and adverse effects', 'postoperative nausea and vomiting (PONV', 'number of vomiting episodes and use of antiemetics', 'Postoperative Nausea and Vomiting', 'IVPCA due to PONV', 'nausea', 'discontinuation of IVPCA due to PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.0446875,"Further, compared with the control group, the droperidol group had reduced nausea up to 24 hours after surgery (P < 0.01), and the number of vomiting episodes and use of antiemetics decreased within 12 hours after surgery (P < 0.01).
","[{'ForeName': 'Ikkou', 'Initials': 'I', 'LastName': 'Hirata', 'Affiliation': 'Department of Pharmacy, Kameda General Hospital, Chiba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Pharmacy, Kameda General Hospital, Chiba, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Matsui', 'Affiliation': 'Clinical Research Unit, Kameda Medical Hospital/Kameda College of Health Science, Chiba, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Yoshinuma', 'Affiliation': 'Department of Anesthesiology, Kameda General Hospital, Chiba, Japan.'}, {'ForeName': 'Ryohkan', 'Initials': 'R', 'LastName': 'Funakoshi', 'Affiliation': 'Department of Pharmacy, Kameda General Hospital, Chiba, Japan.'}]","Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques",['10.18433/jpps30902']
1881,32569643,Effect of the SafeCare© intervention on parenting outcomes among parents in child welfare systems: A cluster randomized trial.,"Child maltreatment has long-lasting negative impacts, and interventions are needed to improve caregiver's parenting skills to prevent maltreatment. This paper reports on a randomized trial comparing the SafeCare© model to services as usual (SAU) for child-welfare referred caregivers. SafeCare is an 18-session behavioral parenting program that teaches skills in positive parent-child interactions, home safety, and child health. SAU is generally unstructured and includes support, crisis management, referrals for need, and parenting education. Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers). Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment. Assessments measured positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales. Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29. Latent change score models (LCSM) using a sandwich estimator consistent with the trial design were used to examine changes in 13 outcomes. Results indicated that SafeCare had small to medium effects for improving several parenting outcomes including supporting positive child behaviors (d = 0.46), proactive parenting (d = 0.25), and two aspects of parenting stress (d = 0.28 and .30). No differential change between groups was found for other indicators, including all indicators of neglect. Parenting programs such as SafeCare offer a promising mode of intervention for child welfare systems. Scale-up of parenting programs can improve parenting, improve child outcomes, and potentially reduce maltreatment. CLINICALTRIAL.GOV REGISTRATION NUMBER: NCT02549287.",2020,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"['Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29', 'child-welfare referred caregivers', 'Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or', 'parents in child welfare systems', 'Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment']","['continue SAU', 'SafeCare']","['several parenting outcomes including supporting positive child behaviors', 'proactive parenting', 'positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales', 'parenting outcomes']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",288.0,0.0742896,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': 'Georgia State University, United States of America. Electronic address: Dwhitaker@gsu.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Self-Brown', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Osborne', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Weeks', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Reidy', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'Georgia State University, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106167']
1882,32571396,"Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.","BACKGROUND


Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes. However, studies, so far, have employed supervised resistance exercise in a laboratory or gym facility which limits the future translation of such exercise in to clinical practice and recommendations. Our primary aim, therefore, is to test the hypothesis, in a randomized controlled trial, that home-based resistance exercise training and gym-based resistance exercise training both reduce HbA1c levels in people with type 2 diabetes compared to control. We will also investigate the effects of home- and gym-based resistance exercise training on muscle strength and body composition.
METHODS


The current study is a three-arm randomised controlled trial which will be conducted with 150 eligible people with type 2 diabetes to compare home-and gym-based resistance exercise training with usual care in Kuwait. The interventions will be delivered by exercise specialists and last for 32 weeks. The primary outcomes are HbA1c with secondary outcomes measuring muscle function, body composition, physical activity and quality of life.
DISCUSSION


Ethical approval has been granted by the Dasman Diabetes Institute ethical review committee (RA/197/2019). Study findings will be disseminated through presentation at scientific conferences and in scientific journals.
TRIAL REGISTRATION


NCT04136730: Retrospectively registered on 21 October 2019.",2020,"BACKGROUND


Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes.","['150 eligible people with type 2 diabetes to compare home-and gym-based', 'people with type 2 diabetes']","['home- and gym-based resistance exercise training', 'resistance exercise training with usual care in Kuwait', 'resistance exercise training and gym-based resistance exercise training']","['HbA1c with secondary outcomes measuring muscle function, body composition, physical activity and quality of life', 'glycated haemoglobin (HbA1c', 'muscle strength and body composition', 'glycaemic control, body composition and muscle strength', 'HbA1c levels']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.141422,"BACKGROUND


Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes.","[{'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al Ozairi', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dalal', 'Initials': 'D', 'LastName': 'Alsaeed', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Taliping', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Jalali', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'El Samad', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mashankar', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Etab', 'Initials': 'E', 'LastName': 'Taghadom', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Guess', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Gray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK. stuart.gray@glasgow.ac.uk.'}]",Trials,['10.1186/s13063-020-04480-2']
1883,31809262,Hypnosis and learning: Pilot study on a group of students.,"Background Milton Erickson was the first to introduce hypnosis as a form of therapy during the post-war period. Numerous studies have evaluated the effects of hypnosis on memory, focusing principally on post-hypnotic amnesia, post-hypnotic hypermnesia, faux memories and learning growth. The aim of the present study was to determine if hypnosis can influence visual-spatial memory by increasing its performance and learning; to do this, we chose to utilise the Corsi Test (backward and forward). Methods Three hundred second-year students enrolled in the psychology faculty at the University of Catania were informed of the research and its modalities, and an e-mail was sent to inquire if they wanted to participate in the experiment. Seventy female students took part in the research; 10 were excluded because they presented a high risk of being influenced under hypnosis. The 60 subjects in the research sample were randomly divided into two groups: the Experimental Group and Control Group. The protocol prescribed administration of the Corsi Test at Time 0 (start) followed by a resting phase of 30 min. The hypnotic state was subsequently introduced, and the Corsi Test was administered again. Results The results of the Corsi Test for the Experimental Group showed statistically significant results (p<0.0004 and p<0.0001), while the results obtained in the Control Group did not show any significance. Conclusions These results led us to believe that hypnosis has the capacity to induce a nervous plasticity that supports learning of visual-spatial memory.",2019,"The results of the Corsi Test for the Experimental Group showed statistically significant results (p<0.0004 and p<0.0001), while the results obtained in the Control Group did not show any significance.","['60 subjects in the research sample', 'Methods Three hundred second-year students enrolled in the psychology faculty at the University of Catania were informed of the research and its modalities, and an e-mail was sent to inquire if they wanted to participate in the experiment', 'Seventy female students took part in the research; 10 were excluded because they presented a high risk of being influenced under hypnosis', 'a group of students']",[],[],"[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]",[],[],300.0,0.0222637,"The results of the Corsi Test for the Experimental Group showed statistically significant results (p<0.0004 and p<0.0001), while the results obtained in the Control Group did not show any significance.","[{'ForeName': 'Coco', 'Initials': 'C', 'LastName': 'Marinella', 'Affiliation': 'Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Ramaci', 'Initials': 'R', 'LastName': 'Tiziana', 'Affiliation': 'Department of Human and Social Sciences, School of Sport Sciences, Kore University, Enna, Italy.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Giuseppe', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Guglielmino', 'Initials': 'G', 'LastName': 'Antonino', 'Affiliation': 'Psychotherapist expert in clinical hypnosis, University of Catania, Catania, Italy.'}, {'ForeName': 'Giulia Di', 'Initials': 'GD', 'LastName': 'Gregorio', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Buscemi', 'Initials': 'B', 'LastName': 'Andrea', 'Affiliation': 'Horus Cooperativa Sociale, Ragusa, Italia.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2017-0082']
1884,32577819,Switching from Warfarin to rivaroxaban induces sufficiency of vitamin K and reduction of arterial stiffness in patients with atrial fibrillation.,"Use of chronic vitamin K antagonist (VKA) induces a long-term deficiency of vitamin K, which may cause arterial stiffness and bone-related disease. Switching from VKA to rivaroxaban could induce rapid sufficiency of vitamin K and improvement of arterial stiffness. The K2 SUMMIT-3 study is a multicenter, open-label, prospective, and randomized design. Patients with atrial fibrillation who have been taking VKA for more than 6 months but less than 10 years were randomly assigned to two groups; those switching from VKA to rivaroxaban and those continuing with VKA medication. The primary endpoint was the percentage difference of brachial-ankle pulse wave velocity (baPWV) in 3 months. A total of 77 patients were randomly assigned to receive rivaroxaban (n = 38) or VKA (n = 39). The average age was 74 ± 9 years. The duration for which VKA was prescribed prior to randomization was 90 ± 87 months.Abnormally high levels of Des-gamma carboxyprothrombin (PIVKA-II) or uncarboxylated osteocalcin (ucOC) indicating vitamin K insufficiency were observed in 100% or 82% of the patients at baseline but it reduced to 2% (p < 0.0001) or 55% (p = 0.01) at 3 months in the rivaroxaban group. To the contrary, theses data had no changes in the VKA group. The percentage difference in baPWV was - 1.4 ± 10.0% vs. 3.5 ± 14.7% in the rivaroxaban and the VKA groups, respectively. (p = 0.02). Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.",2020,Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.,"['Patients with atrial fibrillation who have been taking VKA for more than 6\xa0months but less than 10\xa0years', 'A total of 77 patients', 'patients with atrial fibrillation']","['rivaroxaban', 'VKA', 'chronic vitamin K antagonist (VKA']","['Abnormally high levels of Des-gamma carboxyprothrombin (PIVKA-II) or uncarboxylated osteocalcin (ucOC) indicating vitamin K insufficiency', 'arterial stiffness', 'rapid sufficiency of vitamin K and reduction of arterial stiffness', 'percentage difference of brachial-ankle pulse wave velocity (baPWV', 'baPWV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C1299351', 'cui_str': 'Abnormally high'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0950248', 'cui_str': 'Des-gamma-carboxy prothrombin'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",77.0,0.0510437,Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan. ikari@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Fumie', 'Initials': 'F', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Kiyooka', 'Affiliation': 'Tokai University Oiso Hospital, Oiso, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Nagaoka', 'Affiliation': 'Ebina General Hospital, Ebina, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Tokai University Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Furuki', 'Affiliation': 'Hadano South Gate Clinic, Hadano, Japan.'}, {'ForeName': 'Shigemitsu', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Tokai University Oiso Hospital, Oiso, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01651-8']
1885,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children.
OBJECTIVES


To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
METHODS


240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months.
CONCLUSIONS


If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, 551 W 51st Pl, Hialeah, FL 33012, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, 915 West State Street, West Lafayette, IN 47907-2053, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061']
1886,32584117,Predicting sudden gains before treatment begins: An examination of pretreatment intraindividual variability in symptoms.,"Objective:  Sudden gains during psychotherapy have been found to be predictive of positive treatment outcomes. Previous attempts at predicting occurrence of sudden gains have yielded equivocal findings. Recently, intraindividual variability in symptoms during treatment was suggested as a trans-therapeutic and trans-diagnostic predictor of sudden gains. The goal of the present study was to examine this predictor in Internet-delivered treatment for social anxiety disorder (SAD) and to examine whether this predictor predicts sudden gains when measured before treatment begins.  Method:  We examined data from a preregistered randomized controlled trial (RCT) of Internet-delivered cognitive-behavioral therapy (CBT) for SAD ( n  = 101). We measured variability in symptoms both within-treatment and before treatment (i.e. during waitlist).  Results:  Intraindividual variability in symptoms significantly predicted sudden gains both when measured before treatment or within-treatment and correctly classified 84% and 83% of individuals to sudden gains versus non-sudden gains status, respectively.  Conclusions:  Intraindividual variability in symptoms can predict sudden gains in Internet-delivered treatment for SAD, thus supporting its trans-diagnostic and trans-therapeutic nature. Predicting sudden gains before treatment begins has implications for treatment planning and clinical decision making as well as for personalized tailoring of interventions. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Intraindividual variability in symptoms significantly predicted sudden gains both when measured before treatment or within-treatment and correctly classified 84% and 83% of individuals to sudden gains versus non-sudden gains status, respectively.  ",['social anxiety disorder (SAD'],['Internet-delivered cognitive-behavioral therapy (CBT'],"['Sudden gains', 'sudden gains']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1276802', 'cui_str': 'Sudden'}]",,0.0333064,"Intraindividual variability in symptoms significantly predicted sudden gains both when measured before treatment or within-treatment and correctly classified 84% and 83% of individuals to sudden gains versus non-sudden gains status, respectively.  ","[{'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Shalom', 'Affiliation': 'Department of Psychology, University of Haifa.'}, {'ForeName': 'Asher Y', 'Initials': 'AY', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linkoping University.'}, {'ForeName': 'Or D', 'Initials': 'OD', 'LastName': 'Agassi', 'Affiliation': 'Department of Psychology, University of Haifa.'}, {'ForeName': 'Idan M', 'Initials': 'IM', 'LastName': 'Aderka', 'Affiliation': 'Department of Psychology, University of Haifa.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000587']
1887,32444161,Using a Mobile Phone Application Versus Telephone Assistance During Cardiopulmonary Resuscitation: A Randomized Comparative Study.,"INTRODUCTION


In recent years, the way CPR instructions are given has changed because of the development of new technology that allows bystanders who witness a cardiac arrest to be guided in performing CPR. This study aimed to compare the effectiveness of using a mobile phone application (app) versus telephone operator assistance in performing cardiopulmonary resuscitation (CPR) techniques in simulated settings.
METHODS


A comparative study was performed with 2 intervention groups: (1) mobile phone app and (2) telephone assistance. A total of 128 students participated and were distributed randomly into each intervention group. A CPR observation checklist and standard CPR quality parameter measurements were used for data collection.
RESULTS


The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.81; P < 0.05), asking for help (X 2 (1) = 66.07; P < 0.05), opening of airways (X 2 (1) = 12.03; P < 0.05), checking for breathing (X 2 (1) = 6.10; P < 0.05), and contacting emergency services (X 2 (1) = 12.41; P < 0.05). Regarding the skill level of CPR, no statistically significant differences were found when comparing the 2 intervention groups (X 2 (1) = 0.91; P = 0.33). As for the parameters measured, there were only statistically significant differences found in the item compression fraction (U = 1,593.00; Z = -2.16; P < 0.05), with the group that used the app obtaining better results.
DISCUSSION


Better outcomes were observed in recognizing if the area was safe, asking for help, opening up the airways, checking for breathing, and calling emergency services in the mobile phone app group. However, the results indicated that there were no differences in the CPR parameters, except compression fraction, when the app was used as opposed to being guided by telephone.",2020,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","['128 students participated', 'During Cardiopulmonary Resuscitation']","['mobile phone application (app) versus telephone operator assistance', 'Mobile Phone Application Versus Telephone Assistance', 'mobile phone app and (2) telephone assistance']","['CPR parameters, except compression fraction', 'contacting emergency services', 'item compression fraction', 'checking for breathing', 'opening of airways']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",128.0,0.0187919,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","[{'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Márquez-Hernández', 'Affiliation': ''}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': ''}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Garrido-Molina', 'Affiliation': ''}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'García-Viola', 'Affiliation': ''}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Granados-Gámez', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Aguilera-Manrique', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.015']
1888,32445052,"PPARγ activation by pioglitazone does not suppress cravings for alcohol, and is associated with a risk of myopathy in treatment seeking alcohol dependent patients: a randomized controlled proof of principle study.","RATIONALE


Proinflammatory processes have been implicated in alcohol addiction, craving, and relapse, while studies in experimental animals have suggested that activation of peroxisome proliferator-activated receptor gamma (PPARγ) inhibits proinflammatory signaling. Accordingly, it is hypothesized that medications with PPARγ activity may have therapeutic potential in alcohol dependence.
OBJECTIVES


We conducted a double-blind, placebo-controlled mechanistic proof of principle study in alcohol-dependent inpatients to investigate the effect of pioglitazone on alcohol craving.
METHODS


Participants were treated for withdrawal, if needed, and then randomized to pioglitazone (target dose 45 mg/day) or placebo. Once at target dose, they completed two experimental manipulations: guided imagery, which used personalized auditory scripts to induce alcohol cravings, and a low-dose challenge with i.v. lipopolysaccharide (LPS; 0.8 ng/kg) or placebo, on two separate sessions, in counterbalanced order. Behavioral and endocrine responses as well as CSF levels of proinflammatory cytokines were evaluated.
RESULTS


The study was prematurely terminated after randomization of 16 subjects, following an independent review that established a high risk of myopathy in the active treatment group. Analysis of those who completed the study indicated that pioglitazone was associated with elevated, rather than suppressed alcohol cravings in response to alcohol-associated stimuli. LPS did not induce cravings for alcohol and thus did not lend itself to evaluating pioglitazone effects; however, pioglitazone increased the neuroendocrine stress response to LPS. CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
CONCLUSIONS


Both safety and efficacy biomarker data suggest that pioglitazone lacks potential as a medication for the treatment of alcohol dependence.
CLINICAL TRIAL REGISTRATION


NCT01631630.",2020,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
",['Participants'],"['pioglitazone', 'LPS', 'lipopolysaccharide', 'placebo']","['alcohol cravings', 'CSF levels of proinflammatory cytokines', 'Behavioral and endocrine responses', 'CSF levels of IL-6, TNF-α, or MCP-1']",[],"[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}]",,0.162741,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
","[{'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA. melanies@mail.nih.gov.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Diazgranados', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Umhau', 'Affiliation': 'Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration, Washington, DC, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Kwako', 'Affiliation': 'Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'George', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden.'}]",Psychopharmacology,['10.1007/s00213-020-05540-w']
1889,32445735,"Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.","BACKGROUND


Type 2 diabetes is affecting people at an increasingly younger age, particularly in the Middle East and in north Africa. We aimed to assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes.
METHODS


This open-label, parallel-group, randomised controlled trial (DIADEM-I), done in primary care and community settings in Qatar, compared the effects of an intensive lifestyle intervention with usual medical care on weight loss and glycaemic outcomes in individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region. Participants were randomly allocated (1:1) either to the intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service. The intensive lifestyle intervention comprised a total diet replacement phase, in which participants were given formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support. Participants in the control group received usual diabetes care, which was based on clinical guidelines. The primary outcome was weight loss at 12 months after receiving the assigned intervention. Our analysis was based on the intention-to-treat principle. Key secondary outcomes included diabetes control and remission. The trial was registered with the ISRCTN registry, ISRCTN20754766, and ClinicalTrials.gov, NCT03225339.
FINDINGS


Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study. 147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population. Between baseline and 12 months, the mean bodyweight of participants in the intervention group reduced by 11·98 kg (95% CI 9·72 to 14·23) compared with 3·98 kg (2·78 to 5·18) in the control group (adjusted mean difference -6·08 kg [95% CI -8·37 to -3·79], p<0·0001). In the intervention group, 21% of participants achieved more than 15% weight loss between baseline and 12 months compared with 1% of participants in the control group (p<0·0001). Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR] 12·03 [95% CI 5·17 to 28·03], p<0·0001). 33% of participants in the intervention group had normoglycaemia compared with 4% of participants in the control group (OR 12·07 [3·43 to 42·45], p<0·0001). Five serious adverse events were reported in four participants in the control group; four admissions to hospital because of unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia).
INTERPRETATION


Our findings show that the intensive lifestyle intervention led to significant weight loss at 12 months, and was associated with diabetes remission in over 60% of participants and normoglycaemia in over 30% of participants. The provision of this lifestyle intervention could allow a large proportion of young individuals with early diabetes to achieve improvements in key cardiometabolic outcomes, with potential long-term benefits for health and wellbeing.
FUNDING


Qatar National Research Fund.",2020,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"['147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population', 'Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study', '12·03', 'young individuals with early diabetes', 'individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region', 'early type 2 diabetes (DIADEM-I']","['intensive lifestyle intervention', 'usual diabetes care', 'intensive lifestyle intervention with usual medical care', 'intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service', 'formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support']","['weight loss and glycaemic outcomes', 'diabetes control and remission', 'unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia', 'weight loss', 'diabetes remission', 'normoglycaemia', 'weight loss and improved glycaemia', 'bodyweight and glycaemia', 'Diabetes remission', 'mean bodyweight']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0149881', 'cui_str': 'Orchitis and epididymitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",158.0,0.120849,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"[{'ForeName': 'Shahrad', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar. Electronic address: staheri@me.com.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Zaghloul', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Chagoury', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Elhadad', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Salma Hayder', 'Initials': 'SH', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'El Khatib', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Rasha Abou', 'Initials': 'RA', 'LastName': 'Amona', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'El Nahas', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Suleiman', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alnaama', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Al-Hamaq', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Charlson', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Wells', 'Affiliation': 'University Department of Statistics and Data Science, Cornell University, Ithaca, New York, NY, USA.'}, {'ForeName': 'Samya', 'Initials': 'S', 'LastName': 'Al-Abdulla', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdul Badi', 'Initials': 'AB', 'LastName': 'Abou-Samra', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30117-0']
1890,32445736,"A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.","BACKGROUND


Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity.
METHODS


We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232.
FINDINGS


Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed.
INTERPRETATION


Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions.
FUNDING


US National Institutes of Health.",2020,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[""Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older"", 'women with overweight and 5 kg for women with obesity', '199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up', 'five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA', 'women with overweight or obesity', 'women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83', 'women with overweight or obesity by using telehealth lifestyle interventions', 'pregnant women with overweight or obesity (GLOW', 'Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group']","['telehealth lifestyle intervention or usual antenatal care', 'telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG', ""Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information"", 'primarily telehealth lifestyle intervention', 'telehealth lifestyle intervention']","['perinatal complications', 'weekly rate of GWG', 'weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population', 'gestational weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5329.0,0.152039,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. Electronic address: assiamira.ferrara@kp.org.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Hedderson', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Internal Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Samantha F', 'Initials': 'SF', 'LastName': 'Ehrlich', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tsai', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Juanran', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Galarce', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30107-8']
1891,32449697,The effects of empagliflozin vs metformin on endothelial microparticles in overweight/obese women with polycystic ovary syndrome.,"Context


Endothelial microparticles (EMPs) are novel, surrogate biomarkers of endothelial function and have been shown to be elevated in women with polycystic ovary syndrome (PCOS). It remains poorly understood how pharmacological options for managing PCOS affect EMP levels.
Objective


To characterise and compare the effects of empagliflozin vs metformin on the circulating levels of EMPs in overweight/obese women with PCOS.
Methods


This was a randomised, comparative, 12-week single-centre trial conducted at the Academic Diabetes, Endocrinology and Metabolism Research Centre, Hull, UK. This analysis includes data from 39 overweight/obese women with PCOS who completed the study and were randomised to empagliflozin (15 mg/day) (n = 19) or metformin (1500 mg/day) (n = 20). Blood samples were collected at baseline and 12 weeks after treatment and analysed for specific surface proteins (ICAM-1, VCAM-1, PECAM-1, E-selectin and endoglin) expressed by circulating EMPs using flow cytometry.
Results


In the empagliflozin group, ICAM-1 (P = 0.006), E-selectin (P = 0.016) and VCAM-1 (P = 0.001) EMPs increased significantly following 12 weeks of treatment, but no changes were seen in PECAM-1 (P = 0.93) or endoglin (P = 0.13) EMPs. In the metformin group, VCAM-1 EMPs (P < 0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged. When data were expressed as percentage change from baseline in each group, no significant differences were seen between groups for any biomarker (P-values from 0.22 to 0.80).
Conclusions


Short-term administration of empagliflozin and metformin in overweight/obese women with PCOS appear to increase EMPs expressed by endothelial cells during their activation.",2020,"In the metformin group, VCAM-1 EMPs (p<0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged.","['overweight/obese women with PCOS', 'women with polycystic ovary syndrome (PCOS', 'overweight/obese women with polycystic ovary syndrome', 'overweight/ obese women with PCOS', 'thirty-nine overweight/obese women with PCOS who completed the study']","['empagliflozin vs. metformin', 'empagliflozin and metformin', 'empagliflozin', 'metformin']","['circulating levels of EMPs', 'VCAM-1 EMPs', 'E-selectin', 'Blood samples', 'ICAM-1', 'VCAM-1 (p=0.001) EMPs', 'endothelial microparticles']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}]",,0.10233,"In the metformin group, VCAM-1 EMPs (p<0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged.","[{'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Javed', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papageorgiou', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Leigh A', 'Initials': 'LA', 'LastName': 'Madden', 'Affiliation': 'School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rigby', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Kilpatrick', 'Affiliation': 'Department of Pathology, Sidra Medical and Research Center, Doha, Qatar.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Atkin', 'Affiliation': 'Royal College of Surgeons in Ireland, Al Sayh, Bahrain.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}]",Endocrine connections,['10.1530/EC-20-0173']
1892,32446951,Dexamethasone for the Prevention of a Pain Flare After Palliative Radiation Therapy for Painful Bone Metastases: The Multicenter Double-Blind Placebo-Controlled 3-Armed Randomized Dutch DEXA Study.,"PURPOSE


After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF.
METHODS AND MATERIALS


This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive 8 mg dexamethasone before radiation therapy followed by 3 daily doses (group A), 8 mg dexamethasone followed by 3 doses of placebo (group B), or 4 doses of placebo (group C). Patients reported worst pain scores, study medication side effects, and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a 2-point increase on a 0 to 10 pain scale with no decrease in opioid intake or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or lower. The primary analysis was by intention to treat with patients who had missing data classified as having a PF.
RESULTS


From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for group A, 27% for group B, and 39% for group C (P = .07). Although patients in group B had the lowest PF incidence, a relatively high percentage did not return to baseline pain levels, indicating pain progression. The mean duration of PF was 2.1 days for group A, 4.5 days for group B, and 3.3 days for group C (P = .0567). Dexamethasone postponed PF occurrence; in group A 52% occurred on days 2 to 5 versus 73% in group B and 99% in group C (P = .02). Patients in group A reported lower mean pain scores on days 2 to 5 than those in group B or C (P < .001). Side effects were similar.
CONCLUSIONS


There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on days 2 to 5.",2020,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"['patients with painful bone metastases from solid tumors randomly to receive A: 8 mg', 'painful bone metastases', 'From January 2012 to April 2016, 295 patients were randomized', 'painful bone metastases up to 44% of patients report a pain flare (PF']","['radiotherapy', 'dexamethasone', 'dexamethasone before radiotherapy', 'Dexamethasone', 'palliative radiotherapy', 'placebo']","['mean duration of PF', 'PF incidence', 'incidence of radiation-induced PF', 'Side effects', 'mean pain scores', 'opioid intake', 'PF', 'pain score', 'worst pain scores, study medication side effects and opioid intake', 'PF occurrence', 'lowest PF-incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",295.0,0.596742,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"[{'ForeName': 'Yvette M', 'Initials': 'YM', 'LastName': 'van der Linden', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Centre, Leiden, the Netherlands; Centre of Expertise in Palliative Care, Leiden University Medical Centre, Leiden, the Netherlands. Electronic address: ymvanderlinden@lumc.nl.'}, {'ForeName': 'Paulien G', 'Initials': 'PG', 'LastName': 'Westhoff', 'Affiliation': 'Department of Radiotherapy, University Medical Centre Utrecht, Utrecht, the Netherlands; Department of Radiotherapy, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Department of Biostatistics, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'van Baardwijk', 'Affiliation': 'MAASTRO, Maastricht, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Vries', 'Affiliation': 'Department of Radiotherapy, National Cancer Institute, Amsterdam, the Netherlands; Department of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiotherapy, Medical Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Wiggenraad', 'Affiliation': 'Department of Radiotherapy, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bakri', 'Affiliation': 'Department of Radiotherapy, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Gerda', 'Initials': 'G', 'LastName': 'Wester', 'Affiliation': 'Radiotherapy Group Arnhem, Arnhem, the Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'de Pree', 'Affiliation': 'Department of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Lieneke', 'Initials': 'L', 'LastName': 'van Veelen', 'Affiliation': 'ZRTI, Vlissingen, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Budiharto', 'Affiliation': 'Department of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Schippers', 'Affiliation': 'Bernard Verbeeten Institute, Tilburg, the Netherlands.'}, {'ForeName': 'Anna K L', 'Initials': 'AKL', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'de Graeff', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.007']
1893,32449083,Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Heart Failure Events in Patients with Type 2 Diabetes Mellitus: A Cost Per Outcome Analysis.,"BACKGROUND AND OBJECTIVE


Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have significant efficacy in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) mortality in patients with type 2 diabetes mellitus (T2DM). However, there are differences in HF outcomes between the SGLT2i. Therefore, we compared the cost needed to achieve these outcomes between empagliflozin, canagliflozin, and dapagliflozin.
METHODS


We calculated the cost needed to treat (CNT) in order to prevent one event of hHF or CV mortality, by multiplying the annualized number needed to treat (NNT) to prevent one event, by the annual cost of each therapy. Efficacy estimates were extracted from published randomized controlled trial (RCT) data. A sensitivity analysis was performed to mitigate differences between the RCT populations. Drug costs were extracted from the 2020 US National Average Drug Acquisition Cost listing.
RESULTS


We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin. The sensitivity analysis confirmed the cost advantage of empagliflozin.
CONCLUSIONS


Our findings suggest that empagliflozin prescribed for preventing CV death or hHF in T2DM patients seems to be cost saving compared to treatment with canagliflozin, and dapagliflozin.",2020,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Sodium-glucose cotransporter 2 inhibitors (SGLT2i', 'empagliflozin', 'empagliflozin, canagliflozin, and dapagliflozin', 'Sodium-Glucose Cotransporter 2 Inhibitors']","['HF outcomes', 'cardiovascular (CV) mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.173062,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","[{'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Arbel', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel. ronen.arbel@gmail.com.'}, {'ForeName': 'Enis', 'Initials': 'E', 'LastName': 'Aboalhasan', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hammerman', 'Affiliation': 'Department of Pharmaceutical Technology Assessment, Clalit Health Services Headquarters, Tel-Aviv, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Azuri', 'Affiliation': 'Diabetes Clinic, Central District, Maccabi Healthcare Services, Tel Aviv, Israel.'}]",Clinical drug investigation,['10.1007/s40261-020-00929-z']
1894,32464280,"Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial.","BACKGROUND


There is a high unmet clinical need for treatments of advanced/metastatic biliary tract cancers after progression on first-line chemotherapy. Regorafenib has demonstrated efficacy in some gastrointestinal tumors that progress on standard therapies.
PATIENTS AND METHODS


REACHIN was a multicenter, double-blind, placebo-controlled, randomized phase II study designed to evaluate the safety and efficacy of regorafenib in patients with nonresectable/metastatic biliary tract cancer that progressed after gemcitabine/platinum chemotherapy. Patients were randomly assigned 1 : 1 to best supportive care plus either regorafenib 160 mg once daily 3 weeks on/1 week off or placebo until progression or unacceptable toxicity. No crossover was allowed. The primary objective was progression-free survival (PFS). Secondary objectives were response rate, overall survival, and translational analysis.
RESULTS


Sixty-six patients with intrahepatic (n = 42), perihilar (n = 6), or extrahepatic (n = 9) cholangiocarcinoma, or gallbladder carcinoma (n = 9) were randomized, 33 to each treatment group (33 per group). At a median follow-up of 24 months, all patients had progressed and six patients were alive. Median treatment duration was 11.0 weeks [95% confidence interval (CI): 6.0-15.9] in the regorafenib group and 6.3 weeks (95% CI: 3.9-7.0) in the placebo group (P = 0.002). Fourteen of 33 patients (42%) in the regorafenib group had a dose reduction. Stable disease rates were 74% (95% CI: 59-90) in the regorafenib group and 34% with placebo (95% CI: 18-51; P = 0.002). Median PFS in the regorafenib group was 3.0 months (95% CI: 2.3-4.9) and 1.5 months (95% CI: 1.2-2.0) in the placebo group (hazard ratio 0.49; 95% CI: 0.29-0.81; P = 0.004) and median overall survival was 5.3 months (95% CI: 2.7-10.5) and 5.1 months (95% CI: 3.0-6.4), respectively (P = 0.28). There were no unexpected/new safety signals.
CONCLUSION


Regorafenib significantly improved PFS and tumor control in patients with previously treated metastatic/unresectable biliary tract cancer in the second- or third-line setting.
CLINICAL TRIAL REGISTRATION


The trial is registered in the European Clinical Trials Register database (EudraCT 2012-005626-30) and at ClinicalTrials.gov (NCT02162914).",2020,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"['advanced/metastatic biliary tract cancers (BTC) after progression on first-line chemotherapy', 'patients with previously treated metastatic/unresectable BTC in the second- or third-line setting', 'locally advanced/metastatic biliary tumors', 'patients with nonresectable/metastatic BTC that progressed after', 'Sixty-six patients with intra-hepatic (n=42), peri-hilar (n=6), or extra-hepatic (n=9) cholangiocarcinoma, or gallbladder carcinoma (n=9']","['regorafenib', 'supportive care plus either regorafenib', 'Regorafenib', 'gemcitabine/platinum chemotherapy', 'gemcitabine and platinum-based chemotherapy', 'placebo']","['PFS and tumor control', 'Median PFS', 'median OS', 'Stable disease rates', 'Median treatment duration', 'safety and efficacy', 'progression-free survival (PFS', 'response rate, overall survival (OS), and translational analysis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0005426', 'cui_str': 'Neoplasm of biliary tract'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0235782', 'cui_str': 'Carcinoma of gallbladder'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",66.0,0.690482,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demols', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: anne.demols@erasme.ulb.ac.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van den Eynde', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Houbiers', 'Affiliation': 'Oncology Department, Saint-Joseph Community Health Center, Liège, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Oncology Department - University Hospital Antwerp, Edegem, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marechal', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delaunoit', 'Affiliation': 'GE Department, INDC Entité Jolimontoise, Haine-St-Paul, Belgium.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Goemine', 'Affiliation': 'Oncology Department, Cliniques et Maternité Ste Elisabeth, Namur, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'GE Department - Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Holbrechts', 'Affiliation': 'Oncology Department, Centre Hospitalier Universitaire A. Paré, Mons, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paesmans', 'Affiliation': 'Data Center, Institut J. Bordet, Brussels, Belgium.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.018']
1895,32464289,Comparative analysis of the efficacy and safety of endovascular and endoscopic interventions on the gonadal veins in the treatment of pelvic congestion syndrome.,"OBJECTIVE


Comparison of the efficacy and safety of endovascular and endoscopic interventions on the gonadal vein in the treatment of patients with pelvic congestion syndrome (PCS).
METHODS


We evaluated the treatment outcomes in 95 patients with PCS who underwent endovascular embolization of gonadal veins (EEGV) (group 1, n = 67) or endoscopic resection of the gonadal veins (ERGV) (group 2; n = 28). A comparative analysis of the efficacy and safety of EEGV and ERGV in the treatment of PCS included assessments of their effects on pelvic venous pain, pelvic venous reflux, diameter of the pelvic veins, and restoration of daily activity, as well as treatment safety assessment. Clinical examinations and ultrasound studies of the pelvic veins were repeated at 1, 10, and 30 days, and 36 months after EEGV and ERGV. Pain was assessed using a visual analogue scale and the Von Korff questionnaire.
RESULTS


A decrease in pelvic venous pain intensity was observed at 3.6 ± 1.4 days after EEGV and 2.5 ± 0.8 days after ERGV (P = .49 between the groups). At 1 month after the intervention, a complete relief of pelvic pain was reported by 52 and 25 patients in the EEGV and ERGV groups, respectively. The rates of valvular incompetence of the uterine veins were decreased from 85% in both groups at baseline to 3% in group 1 and 0% in group 2 at 36 months after the intervention, respectively. In the early postprocedural period, pain in the femoral or jugular vein puncture site was reported by eight patients (12%) who underwent EEGV (2.2 ± 0.7 scores). Postembolization syndrome was diagnosed in 13 patients (19.4%). After ERGV, all patients experienced pain in the area of the surgical wound, with a severity of 3.9 ± 0.5 scores. Hematoma at the puncture site of the main vein was observed in 6% of patients after EEGV. Protrusion of coils was identified in three patients (4.5%). The VTE incidence was four times greater in group 1 vs group 2 (14 vs 3 patients; P < .05). The relative risk of this complication after EEGV was 1.4 (95% confidence interval, 1.146-1.732). In two patients (7.1%) after the bilateral laparoscopic resection of the gonadal veins, an ileus developed. No complications of anesthesia were observed in either group.
CONCLUSIONS


Endovascular and endoscopic techniques for decreasing blood flow through the gonadal veins are effective and safe in treating the PCS. The obvious advantages of EEGV are minimal injury and possibility to perform procedure under local anesthesia. The ERGV is associated with at least similar and, in some cases, even superior outcomes, in the terms of significantly (P < .05) shorter time to the postprocedural pain relief and avoiding postembolization syndrome.",2020,The rates of valvular incompetence of the uterine veins were decreased from 85% in both groups at baseline to 3% in group 1 and 0% in group 2 at 36 months after the intervention.,"['pelvic congestion syndrome', 'patients with pelvic congestion syndrome (PCS', '95 patients with PCS who underwent', 'group 1, n=67) or']","['Endovascular and endoscopic techniques', 'endoscopic resection of the gonadal veins (ERGV', 'endovascular embolization of gonadal veins (EEGV', 'endovascular and endoscopic interventions', 'EEGV', 'ERGV', 'EEGV and ERGV']","['pelvic venous pain (PVP), pelvic venous reflux, diameter of the pelvic veins, and restoration of daily activity', 'complete relief of pelvic pain', 'pain in the femoral or jugular vein puncture site', 'complications of anesthesia', 'postprocedural pain relief and avoiding PES', 'PVP intensity', 'Pain', 'relative risk (RR', 'Postembolization syndrome (PES', 'pain', 'visual analogue scale (VAS) and the Von Korff questionnaire', 'blood flow', 'VTE incidence', 'Postprocedural pain', 'rates of valvular incompetence of the uterine veins', 'Protrusion of coils']","[{'cui': 'C0152078', 'cui_str': 'Pelvic congestion syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0457354', 'cui_str': 'Gonadal vein'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226791', 'cui_str': 'Structure of pelvic vein'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0022427', 'cui_str': 'Structure of jugular vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0392008', 'cui_str': 'Complication of anesthesia'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042300', 'cui_str': 'Valvular regurgitation'}, {'cui': 'C0226787', 'cui_str': 'Structure of uterine vein'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}]",95.0,0.0344242,The rates of valvular incompetence of the uterine veins were decreased from 85% in both groups at baseline to 3% in group 1 and 0% in group 2 at 36 months after the intervention.,"[{'ForeName': 'Sergey Gennadievich', 'Initials': 'SG', 'LastName': 'Gavrilov', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, Moscow, Russia. Electronic address: gavriloffsg@mail.ru.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sazhin', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Gennady', 'Initials': 'G', 'LastName': 'Krasavin', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Moskalenko', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Nadeshda', 'Initials': 'N', 'LastName': 'Mishakina', 'Affiliation': 'Savelyev University Surgical Clinic, Pirogov Russian National Research Medical University, Moscow, Russia.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.05.013']
1896,32580977,Home monitoring with technology-supported management in chronic heart failure: a randomised trial.,"OBJECTIVES


We aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients' quality of life than digital home monitoring alone.
METHODS


In a two-armed partially blinded parallel randomised controlled trial, seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years SD 11.1; left ventricular ejection fraction 32.9% SD 15.4). Participants in both study arms were given a tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. Participants randomised to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of guideline-recommended medical therapy for chronic HF and major comorbidities, measured as a composite opportunity score (total number of recommended treatment given divided by the total number of opportunities the treatment should have been given, with a score 1 indicating 100% adherence to recommendations). Co-primary outcome was change in physical score of Minnesota Living with Heart Failure questionnaire.
RESULTS


101 patients were randomised to 'enhanced self-management' and 101 to 'supported medical management'. At the end of follow-up, the opportunity score was 0.54 (95% CI 0.46 to 0.62) in the control arm and 0.61 (95% CI 0.52 to 0.70) in the intervention arm (p=0.25). Physical well-being of participants also did not differ significantly between the groups (17.4 (12.4) mean (SD) for control arm vs 16.5 (12.1) in treatment arm; p for change=0.84).
CONCLUSIONS


Central provision of tailored specialist management in a multi-morbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
TRIAL REGISTRATION NUMBER


ISRCTN86212709.",2020,"However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
","['seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years', 'chronic heart failure', '101 patients']","[""enhanced self-management' and 101 to 'supported medical management"", 'digital home monitoring with centralised specialist support', 'additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment', 'Home monitoring with technology-supported management', 'tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring']","['use of guideline-recommended medical therapy for chronic HF and major comorbidities', 'physical score of Minnesota Living with Heart Failure questionnaire']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0702196', 'cui_str': 'Blood investigation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",202.0,0.142842,"However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
","[{'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Rahimi', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom kazem.rahimi@georgeinstitute.ox.ac.uk.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Nazarzadeh', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ana-Catarina', 'Initials': 'AC', 'LastName': 'Pinho-Gomes', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Salimi-Khorshidi', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Fitzpatrick', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Denis', 'Affiliation': 'Oxford Academic Health Science Network, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cleland', 'Affiliation': 'National Heart and Lung Institute, Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-316773']
1897,32472742,"Efficacy of NEPA, a fixed antiemetic combination of netupitant and palonosetron, vs a 3-day aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in Chinese patients receiving highly emetogenic chemotherapy (HEC) in a randomized Phase 3 study.","NEPA is the only fixed combination antiemetic, comprised of an NK 1  RA (netupitant) and a 5-HT 3  RA (palonosetron). In the first head-to-head trial to compare NK 1  RA-containing regimens, a single oral dose of NEPA was non-inferior to a 3-day aprepitant/granisetron (APR/GRAN) regimen for the primary endpoint of overall (0-120 hours) complete response (no emesis/no rescue). This pre-specified analysis evaluates the efficacy of NEPA versus APR/GRAN in the subset of Chinese patients in the study. In addition, efficacy in patients at greatest emetic risk receiving high-dose cisplatin (≥70 mg/m 2  ) was explored. Chemotherapy-naïve patients with solid tumors in this randomized, double-blind study received either a single dose of NEPA prior to cisplatin-based chemotherapy or a 3-day regimen of APR/GRAN, both with dexamethasone on Days 1-4. Efficacy was evaluated through complete response, no emesis, and no significant nausea rates during the acute (0-24 hours), delayed (25-120 hours) and overall phases as well as individual days post-chemotherapy, as the daily course of CINV protection is often unstudied. The Chinese subset included 667 patients; of these, 363 (54%) received high-dose cisplatin. Baseline characteristics were comparable. While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3-5 in both the Chinese patients and also in those receiving high-dose cisplatin. As a fixed oral NK 1  RA/5HT 3  RA combination given once/cycle, NEPA is a convenient highly effective prophylactic antiemetic that may offer better protection from CINV than a 3-day APR/GRAN regimen on Days 3-5 following highly emetogenic chemotherapy.",2020,"While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3-5 in both the Chinese patients and also in those receiving high-dose cisplatin.","['The Chinese subset included 667 patients; of these, 363 (54%) received', 'naïve patients with solid tumors', 'Chinese patients in the study', 'Chinese patients receiving highly']","['NEPA prior to cisplatin-based chemotherapy', 'granisetron (APR/GRAN', 'Chemotherapy', 'high-dose cisplatin', 'dexamethasone', 'NEPA', 'cisplatin', 'NEPA versus APR/GRAN', 'emetogenic chemotherapy (HEC']","['breakthrough CINV', 'nausea and vomiting (CINV', 'response rates', 'Efficacy', 'complete response, no emesis', 'nausea rates']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus'}]","[{'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",5.0,0.202667,"While response rates were similar for NEPA and APR/GRAN during the acute, delayed and overall phases, significantly fewer NEPA patients experienced breakthrough CINV on individual Days 3-5 in both the Chinese patients and also in those receiving high-dose cisplatin.","[{'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Affiliated Tumour Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Guihua', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Changsha Central Hospital, Changsha, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Lanzarotti', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Chessari', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Cancer medicine,['10.1002/cam4.3123']
1898,32472768,Population-level viral suppression among pregnant and postpartum women in a universal test and treat trial.,"OBJECTIVE(S)


We sought to determine whether universal 'test and treat' (UTT) can achieve gains in viral suppression beyond universal antiretroviral treatment (ART) eligibility during pregnancy and postpartum, among women living with HIV.
DESIGN


A community cluster randomized trial.
METHODS


The SEARCH UTT trial compared an intervention of annual population testing and universal ART with a control of baseline population testing with ART by country standard, including ART eligibility for all pregnant/postpartum women, in 32 communities in Kenya and Uganda. When testing, women were asked about current pregnancy and live births over the prior year and, if HIV-infected, had their viral load measured. Between arms, we compared population-level viral suppression (HIV RNA <500 copies/ml) among all pregnant/postpartum HIV-infected women at study close (year 3). We also compared year-3 population-level viral suppression and predictors of viral suppression among all 15 to 45-year-old women by arm.
RESULTS


At baseline, 92 and 93% of 15 to 45-year-old women tested for HIV: HIV prevalence was 12.6 and 12.3%, in intervention and control communities, respectively. Among HIV-infected women self-reporting pregnancy/live birth, prevalence of viral suppression was 42 and 44% at baseline, and 81 and 76% (P = 0.02) at year 3, respectively. Among all 15 to 45-year-old HIV-infected women, year-3 population-level viral suppression was higher in intervention (77%) versus control (68%; P < 0.001). Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43). Younger age was a risk factor for nonsuppression in both arms.
CONCLUSION


The SEARCH intervention resulted in higher population viral suppression among pregnant/postpartum women than a control of baseline universal testing with ART eligibility for pregnant/postpartum women.",2020,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"['all pregnant/postpartum women, in 32 communities in Kenya and Uganda', 'pregnant and postpartum women in a universal test and treat trial', '15 to 45-year-old women by arm', 'women living with HIV']","[""universal 'test and treat' (UTT""]","['year-3 viral suppression', 'HIV: HIV prevalence', 'viral suppression', 'year-3 population-level viral suppression', 'Pregnancy/live birth', 'population viral suppression']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.305022,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kabami', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Balzer', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'Hachem', 'Initials': 'H', 'LastName': 'Saddiki', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mucunguzi', 'Initials': 'M', 'LastName': 'Atukunda', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Koss', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Musoke', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Maya L', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': 'University of California, Berkeley, California, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002564']
1899,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND


The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS


Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION


Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
1900,32470975,Vitamin B-12 Supplementation during Pregnancy and Early Lactation Does Not Affect Neurophysiologic Outcomes in Children Aged 6 Years.,"BACKGROUND


Deficiency of vitamin B-12 is common in pregnant Indian women. Assessment of neurophysiological measures using event-related potentials (ERPs) may yield additional information on the effects of maternal B-12 supplementation on child brain function.
OBJECTIVES


The objective of the study was to evaluate the effects of vitamin B-12 supplementation (50 μg daily orally) during pregnancy on the childhood ERP measures of positive waveform ∼300 ms after stimulus (P300) and mismatch negativity.
METHODS


This study was a follow-up of children born to pregnant women who received oral vitamin B-12 supplements (n = 62) compared with children of pregnant women who received placebo (n = 70) from a randomized controlled trial. The mean ± SD child age was 72 ± 1 mo. We used the Enobio system to assess the ERP measures P300 and mismatch negativity.
RESULTS


There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups. We combined the intervention and placebo groups for secondary analyses. On multiple variable regression analysis after adjusting for treatment group, intrauterine growth restriction, and home environment, P300 amplitude in children was significantly higher in the lowest tertile of third-trimester maternal methylmalonic acid (MMA) concentrations (β = 3034.04; 95% CI: 923.24, 5144.83) compared with the highest MMA tertile (β = 1612.12; 95% CI: -258.86, 3483.10, P = 0.005).
CONCLUSIONS


While no significant effects of maternal vitamin B-12 supplementation on children's ERP measures were seen at 72 mo, elevated maternal MMA concentrations in the third trimester were negatively associated with P300 amplitude in children. It may be worthwhile to study the impact of maternal and infant vitamin B-12 supplementation on childhood brain structure and function in longer and larger trials. The parent trial was registered at clinicaltrials.gov as NCT00641862.",2020,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","['children born to pregnant women who received', 'n\xa0=\xa062) compared with children of pregnant women who received', 'during Pregnancy and Early Lactation', 'Children', 'Aged 6 Years', 'pregnant Indian women']","['event-related potentials (ERPs', 'vitamin B-12 supplementation', 'oral vitamin B-12 supplements', 'maternal vitamin B-12 supplementation', 'Vitamin B-12 Supplementation', 'placebo']","['childhood ERP measures of positive waveform ∼300\xa0ms after stimulus (P300) and mismatch negativity', 'amplitudes, and latencies of the P300 results and the mismatch negativity', ""children's ERP measures"", 'ERP measures P300 and mismatch negativity', 'maternal MMA concentrations', 'Neurophysiologic Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.385632,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayachandra', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Department of Biostatistics, St. John's Medical College, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tor Arne', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hosptial Trust, Lillehammer, Norway.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa123']
1901,32579807,Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD.,"BACKGROUND


Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β 2 -agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking.
METHODS


In a 52-week, phase 3, randomized trial to evaluate the efficacy and safety of triple therapy at two dose levels of inhaled glucocorticoid in patients with moderate-to-very-severe COPD and at least one exacerbation in the past year, we assigned patients in a 1:1:1:1 ratio to receive twice-daily inhaled doses of triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide], a LAMA [18 μg of glycopyrrolate], and a LABA [9.6 μg of formoterol]) or one of two dual therapies (18 μg of glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol). The primary end point was the annual rate (the estimated mean number per patient per year) of moderate or severe COPD exacerbations, as analyzed in the modified intention-to-treat population with the use of on-treatment data only.
RESULTS


The modified intention-to-treat population comprised 8509 patients. The annual rates of moderate or severe exacerbations were 1.08 in the 320-μg-budesonide triple-therapy group (2137 patients), 1.07 in the 160-μg-budesonide triple-therapy group (2121 patients), 1.42 in the glycopyrrolate-formoterol group (2120 patients), and 1.24 in the budesonide-formoterol group (2131 patients). The rate was significantly lower with 320-μg-budesonide triple therapy than with glycopyrrolate-formoterol (24% lower: rate ratio, 0.76; 95% confidence interval [CI], 0.69 to 0.83; P<0.001) or budesonide-formoterol (13% lower: rate ratio, 0.87; 95% CI, 0.79 to 0.95; P = 0.003). Similarly, the rate was significantly lower with 160-μg-budesonide triple therapy than with glycopyrrolate-formoterol (25% lower: rate ratio, 0.75; 95% CI, 0.69 to 0.83; P<0.001) or budesonide-formoterol (14% lower: rate ratio, 0.86; 95% CI, 0.79 to 0.95; P = 0.002). The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group.
CONCLUSIONS


Triple therapy with twice-daily budesonide (at either the 160-μg or 320-μg dose), glycopyrrolate, and formoterol resulted in a lower rate of moderate or severe COPD exacerbations than glycopyrrolate-formoterol or budesonide-formoterol. (Funded by AstraZeneca, ETHOS ClinicalTrials.gov number, NCT02465567.).",2020,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group.
","['patients with moderate-to-very-severe COPD and at least one exacerbation in the past year', 'Moderate-to-Very-Severe COPD', 'chronic obstructive pulmonary disease (COPD', '8509 patients']","['LAMA', 'glycopyrrolate-formoterol', 'inhaled glucocorticoid', 'triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide', 'glycopyrrolate-formoterol or budesonide-formoterol', 'LABA [9.6 μg of formoterol', 'inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA', 'glycopyrrolate, and formoterol', 'glycopyrrolate', 'budesonide-formoterol', 'glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol']","['moderate or severe COPD exacerbations', 'incidence of confirmed pneumonia', 'annual rates of moderate or severe exacerbations', 'incidence of any adverse event', 'efficacy and safety', 'annual rate', 'rate of moderate or severe COPD exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.540992,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group.
","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'McLaren', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916046']
1902,32443306,Prospective randomized controlled trial study of Luofengning granule in the treatment of unstable angina.,"INTRODUCTION


Although the current western treatment plans for unstable angina (UA) has been optimized in past decades, UA still is a common phenotype of acute coronary syndrome and significantly influence the quality of life and endanger lives. In China, the clinical application of Chinese herb medicine is considered as an effective approach to treating UA and widely recognized by patients. In clinical practices, we found Luofengning granule (LFN-G) could improve clinical manifestations of patients with UA, but there is lack of rigorous proof of evidence-based medicine. This trial aims to further evaluate the efficacy of LFN-G in the treatment of UA.
METHODS


A prospective, open-label, randomized, placebo-controlled clinical will be performed. A total of 60 patients diagnosed with UA will be randomly allocated to either the treatment group or the control group with a 1:1 ratio. The participants in the treatment group will receive LFN-G treatment and the participants in the control group will receive placebo. Meanwhile, both groups continue to undergo standard western medicine treatments. The duration of interventions is 4 weeks. The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death. Secondary outcomes include Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4). In addition, some biochemical indexes of blood and hematological indexes will be used to assess the safety of treatments. Any adverse effects of the treatment will be recorded.
DISCUSSION


The results of this trial will provide compelling evidence of the efficacy and safety of LFN-G for treatment of UA and preliminarily reveal the potential mechanism of how LFN-G acts. Finally, it will widen treatment options for patients with UA.",2020,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","['unstable angina', '60 patients diagnosed with UA', 'patients with UA']","['Luofengning granule', 'LFN-G treatment', 'LFN-G', 'placebo']","['Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4', 'incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death']","[{'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}]",60.0,0.0824664,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatology, Tianjin Third Central Hospital, Tianjin.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'School of Life Science.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}]",Medicine,['10.1097/MD.0000000000020025']
1903,32445738,"Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial.","BACKGROUND


People with type 1 diabetes who use continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) often remove their pump before extended periods of exercise, but this approach might result in reduced glycaemic control and increased risk of hyperglycaemia and ketogenesis. We aimed to assess the efficacy and safety of a hybrid approach, in which basal insulin delivery was divided between CSII and a daily injection of insulin degludec.
METHODS


In this single-centre, open-label, proof-of-concept, randomised crossover trial done at the LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII. Participants were randomly assigned (1:1) by use of a computer-generated sequence to one of two sequences of either usual CSII, involving the continuation of the participant's usual CSII regimen, followed by crossover to hybrid CSII, in which the delivery of the participant's usual daily basal insulin dose was split (50% delivered by CSII and 50% delivered by a once-daily morning injection of 100 U/mL insulin degludec), or the opposite sequence (ie, hybrid CSII followed by crossover to usual CSII). Treatment was not masked to the investigators or participants. For each intervention, participants completed a moderate-intensity and a high-intensity in-clinic exercise session in the first week, followed by four high-intensity and two moderate-intensity home-based exercise sessions in the subsequent 3 weeks. Insulin pumps were suspended or disconnected 60 min before exercise and reconnected immediately after exercise during both treatment regimens. The coprimary outcomes were: (1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose after moderate-intensity exercise, measured by continuous glucose monitoring in the 6-h period from the start of the high-intensity and moderate-intensity in-clinic exercise sessions. Outcomes were assessed in a modified intention-to-treat population that included all participants who started both intervention phases and completed all of the in-clinic exercise visits. This trial is registered with ClinicalTrials.gov, NCT03838783, and is complete.
FINDINGS


Between May 15, 2018, and March 5, 2019, we assessed 43 patients for eligibility, of whom 31 were randomly assigned to receive the usual CSII regimen (n=14) or hybrid CSII regimen (n=17) in the first phase (before crossover). The analysis population consisted of 24 participants who completed both study phases. Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]). Participants on the hybrid CSII regimen also showed a higher time in blood glucose range of 4-10 mmol/L during home-based exercise sessions (mean difference 23 min [95% CI -1 to 46], p=0·055), with significantly lower time spent in hyperglycaemia than participants on the usual CSII regimen (mean difference 25 min [2-48], p=0·04). These exploratory outcomes also showed no significant difference in the amount of time spent in hypoglycaemia, nor the number of hypoglycaemic events, between the two interventions. There were three study-related adverse events reported with the usual CSII regimen (two hypotension events and one nausea event) and four with the hybrid CSII regimen (two hypotension events and two nausea events).
INTERPRETATION


A hybrid regimen of injected insulin degludec and CSII (with pump removal during exercise) appears to be safe and effective in adults with type 1 diabetes who exercise regularly. This approach could offer improved glycaemic control immediately after exercise and should be further assessed in a larger-scale randomised trial.
FUNDING


Novo Nordisk.",2020,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","['People with type 1 diabetes who use', '24 participants who completed both study phases', '43 patients for eligibility, of whom 31', 'LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII', 'physically active adults with type 1 diabetes (FIT Untethered', 'adults with type 1 diabetes who exercise regularly']","['Flexible insulin therapy', 'injected insulin degludec and CSII (with pump removal during exercise', 'usual CSII regimen (n=14) or hybrid CSII regimen', 'continuous subcutaneous insulin infusion (CSII, or insulin pump therapy', 'insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise']","['longer time in blood glucose range', 'higher time in blood glucose range', 'time spent in hypoglycaemia, nor the number of hypoglycaemic events', 'efficacy and safety', '1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose', 'time spent in hyperglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",43.0,0.0906429,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","[{'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada. Electronic address: ronnie.aronson@lmc.ca.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McGaugh', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30114-5']
1904,32452590,The effects of indoor ambient temperature at work on physiological adaptation in night shift nurses.,"AIM


To examine the effects of indoor ambient temperature on thermal comfort, night work tolerance (fatigue, sleepiness and night adaptation) and urinary melatonin in night shift nurses.
BACKGROUND


Night shift induces physical stress and mental stress. Night shift work and ambient temperature are associated with work performance. The working environment must be improved for successful night shift working. However, the effects of indoor ambient temperature on night shift nurses are unclear.
METHODS


In this crossover study, 20 participants were divided into two groups of 10 and were assigned to work in one of two thermo-controlled environments (23°C vs. 26°C) during two consecutive night shifts. Thermal and humidity sensation vote, night work tolerance, body temperature and urinary melatonin were assessed.
RESULTS


There were significant differences between the two groups in thermal sensation and body temperature. There were no significant differences in humidity sensation vote or night work tolerance. Urinary melatonin levels decreased significantly during the second 23°C night shift.
CONCLUSION


A temperature of 23°C may exert a positive effect on night shift adaptation.
IMPLICATIONS FOR NURSING MANAGEMENT


Nurses and nursing managers should assess thermal comfort during night shifts, and improved thermal comfort level should be provided to nurses.",2020,There were significant differences between the two groups in thermal sensation vote and body temperature.,"['nursing management Nurses and nursing managers', 'Night Shift Nurses', '20 participants']","['indoor ambient temperature', 'Indoor Ambient Temperature']","['Urinary melatonin levels', 'Thermal and humidity sensation vote, night work tolerance, body temperature, and urinary melatonin', 'thermal comfort, night work tolerance (fatigue, sleepiness, and night adaptation', 'humidity sensation vote or night work tolerance', 'thermal sensation vote and body temperature']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0542496', 'cui_str': 'Ambient temperature'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042978', 'cui_str': 'Voting'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}]",20.0,0.0098016,There were significant differences between the two groups in thermal sensation vote and body temperature.,"[{'ForeName': 'Jeong Hun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'Yeoungsuk', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Research Institute of Nursing Science, Kyungpook National University College of Nursing, Daegu, Korea.'}]",Journal of nursing management,['10.1111/jonm.13052']
1905,32453393,"Supplementation with vitamin D or ω-3 fatty acids in adolescent girls and young women with endometriosis (SAGE): a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain. Despite widespread use, there are no published trials examining the individual effects of vitamin D and omega-3 (n-3) fatty acid supplementation on endometriosis-associated pain in adolescents.
OBJECTIVES


We aimed to determine whether supplementation with vitamin D or ω-3 fatty acids remediates pain, changes frequency of pain medication usage, or affects quality of life in young women with endometriosis.
METHODS


Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled in a double-blind, randomized, placebo-controlled trial. The primary outcome was pain measured by the visual analog scale (VAS). Secondary outcomes were quality of life, pain catastrophizing, and pain medication usage. Participants were randomly assigned to receive 2000 IU vitamin D3, 1000 mg fish oil, or placebo daily for 6 mo.
RESULTS


A total of 147 women were screened and 69 were randomly assigned as follows: 27 to vitamin D3; 20 to fish oil; and 22 to placebo. Participants in the vitamin D arm experienced significant improvement in VAS pain [mean (95% CI) worst pain in the past month, from baseline to 6 mo: 7.0 (6.2, 7.8) to 5.5 (4.2, 6.8), P = 0.02]; however, an improvement of nearly identical magnitude was observed in the placebo arm [6.0 (5.1, 6.9) to 4.4 (3.0, 5.8), P = 0.07]. A more modest improvement was observed in the fish oil arm [5.9 (4.8, 7.0) to 5.2 (3.7, 6.8), P = 0.39]. Neither of the intervention arms were statistically different from placebo.
CONCLUSIONS


In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo. Supplementation with fish oil resulted in about half of the VAS pain reduction of the other 2 arms. Studies are needed to better define the physiology underlying the observed reduction in pain score in the placebo arm that persisted across 6 mo.This trial was registered at clinicaltrials.gov as NCT02387931.",2020,"In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo.","['young women with endometriosis', 'adolescent girls and young women with endometriosis (SAGE', 'A total of 147 women were screened and 69 were randomly assigned as follows: 27 to', 'Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled', 'young women with endometriosis, supplementation with', 'Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain', 'endometriosis-associated pain in adolescents']","['vitamin D or ω-3 fatty acids', 'vitamin D3; 20 to fish oil', '2000 IU vitamin D3, 1000 mg fish oil, or placebo', 'placebo', 'vitamin D', 'vitamin D and omega-3 (n-3) fatty acid supplementation']","['quality of life', 'quality of life, pain catastrophizing, and pain medication usage', 'pain measured by the visual analog scale (VAS', 'pelvic pain', 'VAS pain reduction', 'pain', 'VAS pain', 'pain score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",147.0,0.819757,"In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo.","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Nodler', 'Affiliation': 'Department of Obstetrics and Gynecology, Colorado Center for Reproductive Medicine-Houston, Houston, TX, USA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'DiVasta', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Allison F', 'Initials': 'AF', 'LastName': 'Vitonis', 'Affiliation': ""Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Karevicius', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Malsch', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vishnudas', 'Initials': 'V', 'LastName': 'Sarda', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Medicine, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ayotunde', 'Initials': 'A', 'LastName': 'Fadayomi', 'Affiliation': ""Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Harris', 'Affiliation': 'Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Missmer', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa096']
1906,32450979,Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children-1 study.,"BACKGROUND


Visual inspection (VIS) with radiographic examination (RAD) is the recommended diagnostic strategy for detecting caries in children; however, this recommendation is based on accuracy studies. The authors conducted a clinical trial to compare the detection and subsequent treatment of carious lesions in primary molars performed with VIS alone and with RAD.
METHODS


Children (3-6 years old) were randomly assigned to 2 groups according to the diagnostic strategy used for caries detection on primary molars: VIS or RAD. Participants were diagnosed and treated according to the management plan related to the allocated group. The primary outcome was the number of new operative interventions during the 2-year follow-up period. Other secondary outcomes were also compared. Comparisons were performed with Mann-Whitney test using an intention-to-treat approach.
RESULTS


Of the 252 children included and randomized, 216 were followed-up after 2 years (14.3% attrition rate). There was no difference between the groups for the primary outcome (P = .476). For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group. In addition, the RAD group had a higher number of false-positive results than the VIS group (P < .001).
CONCLUSIONS


Simultaneous use of VIS and RAD for caries diagnosis in primary molars of children who seek dental treatment does not provide additional benefits compared with VIS alone.
PRACTICAL IMPLICATIONS


Dentists should perform VIS only, not RAD, for detecting carious lesions in preschool-aged children. ClinicalTrials.gov: NCT02078453.",2020,"For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group.","['caries in children', 'Children (3-6 years old', 'children through a 2-year randomized clinical trial', '252 children', 'preschool-aged children']","['diagnostic strategy used for caries detection on primary molars: VIS or RAD', 'VIS and RAD', 'Visual inspection (VIS) with radiographic examination (RAD', 'VIS alone and with RAD', 'visual inspection and radiographs']","['restoration replacements', 'number of false-positive results', 'number of new operative interventions']","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",252.0,0.157572,"For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group.","[{'ForeName': 'Laura R A', 'Initials': 'LRA', 'LastName': 'Pontes', 'Affiliation': ''}, {'ForeName': 'Tatiane F', 'Initials': 'TF', 'LastName': 'Novaes', 'Affiliation': ''}, {'ForeName': 'Juan S', 'Initials': 'JS', 'LastName': 'Lara', 'Affiliation': ''}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Gimenez', 'Affiliation': ''}, {'ForeName': 'Bruna L P', 'Initials': 'BLP', 'LastName': 'Moro', 'Affiliation': ''}, {'ForeName': 'Lucila B', 'Initials': 'LB', 'LastName': 'Camargo', 'Affiliation': ''}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Michel-Crosato', 'Affiliation': ''}, {'ForeName': 'Claudio M', 'Initials': 'CM', 'LastName': 'Pannuti', 'Affiliation': ''}, {'ForeName': 'Daniela P', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': ''}, {'ForeName': 'Mariana M', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': ''}, {'ForeName': 'Fausto M', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': ''}]",Journal of the American Dental Association (1939),['10.1016/j.adaj.2020.02.008']
1907,32451005,A comparison of Gordon's functional health patterns model and standard nursing care in symptomatic heart failure patients: A randomized controlled trial.,"BACKGROUND


Heart failure (HF) is associated with poor quality of life and increased morbidity and mortality.
AIM


This study aimed to investigate effect of application of Gordon's functional health pattern (FHP) model in nursing care of symptomatic HF patients on quality of life, morbidity and mortality in the post-discharge 30-day.
METHODS


This is a prospective randomized controlled study conducted in a single center. Experimental group received nursing care planned in accordance with Gordon's FHP model. 60 control and 60 experimental HF patients were included in the study. In the control group nursing care was given according to the standard protocol of the hospital whereas in the experimental group nursing care was given in accordance with Gordon's FHP model. Patients in both groups were followed up after discharge at 30th day.
RESULTS


Mean Minnesota Living with Heart Failure Questionnaire score improved significantly in the experimental group compared to the control group at 30th day (40.2 ± 23.5 vs 62.3 ± 22.9 respectively, p = 0.001). Seven patients (11.7%) in the experimental group and 17 patients (28.3%) in the control group were readmitted in the post discharge 30-day (p = 0.02). Kaplan-Meier survival curve analysis revealed significant difference in 30-day event free survival rates between groups (log-rank p = 0.31).
CONCLUSION


Application of Gordon's FHP model in the nursing care of HF patients was associated with significantly improved quality of life, and reduced hospital readmission rates at 30th day. This was the only independent predictor of 30-day event free survival.",2020,"RESULTS


Mean Minnesota Living with Heart Failure Questionnaire score improved significantly in the experimental group compared to the control group at 30th day (40.2 ± 23.5 vs 62.3 ± 22.9 respectively, p = 0.001).","['symptomatic heart failure patients', '60 control and 60 experimental HF patients were included in the study', 'nursing care of symptomatic HF patients']","[""nursing care planned in accordance with Gordon's FHP model"", ""Gordon's functional health patterns model and standard nursing care"", ""Gordon's functional health pattern (FHP) model""]","['quality of life, and reduced hospital readmission rates', '30-day event free survival rates', 'Mean Minnesota Living with Heart Failure Questionnaire score', 'post discharge 30-day', 'quality of life, morbidity and mortality']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0028683', 'cui_str': 'Plans, Nursing Care'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0612579,"RESULTS


Mean Minnesota Living with Heart Failure Questionnaire score improved significantly in the experimental group compared to the control group at 30th day (40.2 ± 23.5 vs 62.3 ± 22.9 respectively, p = 0.001).","[{'ForeName': 'Sevda', 'Initials': 'S', 'LastName': 'Türen', 'Affiliation': 'T.C.\xa0Istanbul Kültür University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey. Electronic address: sevdamercanhm@hotmail.com.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Enç', 'Affiliation': 'Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151247']
1908,32458092,Retrospective analysis of different regimens for Chinese adults with severe newly diagnosed immune thrombocytopenia.,"To review the efficacy and safety of glucocorticoids combined with different regimens for treating severe immune thrombocytopenia (ITP). Eighty-five severe ITP patients from 2 tertiary hospitals treated with glucocorticoids were enrolled from January 2018 to May 2019 and divided into 4 treatment groups: group A (treated with glucocorticoids), group B (glucocorticoids plus intravenous immunoglobulin (IVIg)), group C (glucocorticoids plus recombinant human thrombopoietin (rhTPO)), and group D (glucocorticoids plus IVIg and rhTPO). Statistical analysis was performed with SPSS 19.0 software. Early responses and response maintenance were assessed at 14 days and 1 month after treatment. Groups B, C and D had higher complete response (CR) and overall response (OR) rates than group A (P < 0.05). Adverse reaction incidences were not significantly different among all groups (P > 0.05). Severe ITP patients who received glucocorticoids with IVIg and rhTPO had higher CRs and ORs at the platelet level, and no significant adverse reactions were observed. Glucocorticoids combined with different regimens had different clinical efficacies for treating severe ITP.",2020,"Groups B, C and D had higher complete response (CR) and overall response (OR) rates than group A (P < 0.05).","['severe immune thrombocytopenia (ITP', 'Chinese adults with severe newly diagnosed immune thrombocytopenia', 'Eighty-five severe ITP patients from 2 tertiary hospitals treated with']","['Glucocorticoids', 'glucocorticoids with IVIg and rhTPO', 'glucocorticoids', 'glucocorticoids), group B (glucocorticoids plus intravenous immunoglobulin (IVIg)), group C (glucocorticoids plus recombinant human thrombopoietin (rhTPO)), and group D (glucocorticoids plus IVIg and rhTPO']","['Adverse reaction incidences', 'adverse reactions', 'complete response (CR) and overall response (OR) rates', 'Early responses and response maintenance']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",85.0,0.0708333,"Groups B, C and D had higher complete response (CR) and overall response (OR) rates than group A (P < 0.05).","[{'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Huai'an Second People's Hospital, Huai'an, Jiangsu, People's Republic of China.""}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gui', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Hui', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': ""Department of Hematology, The Air Force Hospital From Eastern Theater of PLA, Nanjing, 210000, People's Republic of China. gbc1987@163.com.""}]",Clinical and experimental medicine,['10.1007/s10238-020-00630-7']
1909,32459631,Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial.,"BACKGROUND


The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC's diabetes prevention program (DPP).
OBJECTIVE


This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care.
METHODS


Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A 1c  (HbA 1c ) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA 1c  levels.
RESULTS


A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants' weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA 1c  levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by -2.64 kg (SE 0.71; P<.001) and -0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA 1c  level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA 1c  levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA 1c  levels.
CONCLUSIONS


This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342.",2020,The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months.,"['People with Pre-diabetes', '202 participants were recruited and randomized into the intervention (n=101) or control group (n=99', 'Adults with prediabetes (N=202']","['control group receiving usual medical care', 'mobile-delivered, coach-guided DPP or to a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention', 'Mobile Delivery of the Diabetes Prevention Program', 'mobile-delivered DPP']","['risk of overt diabetes', 'HbA1c', 'program engagement as a predictor of changes in weight and HbA1c', 'weight loss', 'weight and BMI', 'weight loss reductions', 'glycemic efficacy', 'changes in weight and hemoglobin A1c (HbA1c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",202.0,0.118825,The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months.,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Toro-Ramos', 'Affiliation': 'Noom, Inc, New York, NY, United States.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michaelides', 'Affiliation': 'Noom, Inc, New York, NY, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anton', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Zulekha', 'Initials': 'Z', 'LastName': 'Karim', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Kang-Oh', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Argyrou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Loukaidou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Charitou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Sze', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}]",JMIR mHealth and uHealth,['10.2196/17842']
1910,32459635,Promoting Employees' Recovery During Shift Work: Protocol for a Workplace Intervention Study.,"BACKGROUND


Shift work can be demanding owing to disturbances in the biological and social rhythms. This can cause short-term negative effects in employees, such as increased fatigue and reduced alertness. A potential way to counteract these negative effects is to enhance employees' recovery from work during working hours.
OBJECTIVE


The aim of this study is to develop and implement an intervention that focuses on promoting ""on-job"" recovery of shift workers.
METHODS


This study is performed in 2 department units with shift workers at a multinational company in the steel industry. For each department, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation. This approach consists of various sessions in which employees and a project group (ie, researchers, line managers, human resource managers, and occupational health experts) provide input on the intervention content and implementation. Intervention effects will be evaluated using pretest and posttest web-based surveys. Digital ecological momentary assessment will be performed to gain insight into the link between the intervention and daily within-person processes. The intervention process and participants' perception of the interventions will be assessed through a process evaluation. Intervention results will be analyzed by performing mixed model repeated measures analyses and multilevel analyses.
RESULTS


This study is supported by the Netherlands Organization for Applied Scientific Research Work and Health Research Program, which is funded by the Ministry of Economic Affairs and supported by the Dutch Ministry of Social Affairs and Employment, program number 19.204.1-3. This study was approved by the institutional review board on February 7, 2019. From June to August 2019, baseline data were collected, and from November to December 2019, the first follow-up data were collected. The second follow-up data collection and data analysis are planned for the first two quarters of 2020. Dissemination of the results is planned for the last two quarters of 2020.
CONCLUSIONS


A strength of this study design is the participatory action approach to enhance the stakeholder commitments, intervention adherence, and compliance. Moreover, since the target group will be participating in the development and implementation of the intervention, the proposed impact will be high. In addition, the short-term as well as the long-term effects will be evaluated. Finally, this study uses a unique combination of quantitative and qualitative evaluation methods. A limitation of this study is that it is impossible to randomly assign participants to an intervention or control group. Furthermore, the follow-up period (6 months) might be too short to establish health-related effects. Lastly, the results of this study might be specific to the department, organization, or sector, which limits the generalizability of the findings. However, as workplace intervention research for shift workers is scarce, this study might serve as a starting point for future research on shift work interventions.",2020,"For each of two departmental units of shift workers, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation.",[],['Digital Ecological Momentary Assessment (EMA'],[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",[],,0.0487991,"For each of two departmental units of shift workers, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation.","[{'ForeName': 'Irene Mw', 'Initials': 'IM', 'LastName': 'Niks', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'van Drongelen', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Elsbeth M', 'Initials': 'EM', 'LastName': 'de Korte', 'Affiliation': 'The Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}]",JMIR research protocols,['10.2196/17368']
1911,32468855,Comparison between two fast threshold strategies: SPARK and SITA in normal subjects.,"BACKGROUND


Numerous fast threshold strategies have been developed in perimetry which use maximum likelihood approaches to estimate the threshold. A recent approach to threshold estimation has been developed estimating the threshold from a limited number of test points which further reduces examination time. This strategy, SPARK, has not been compared to the SITA strategy. The aim of this study was to compare SPARK with SITA in a normal cohort to evaluate within and between strategy agreement in threshold estimates.
METHODS


A total of 83 normal subjects each underwent two visual field examinations with SITA and SPARK on two separate occasions on a randomly selected eye. The eye examined and the order of strategy examined first was randomised but remained constant over the two perimetry visits.
RESULTS


Visual field examination with SPARK Precision was on average 33% faster than SITA Standard. A positive correlation between group mean sensitivities of SITA Standard and SPARK Precision (rho = 0.713, p < 0.001) was found. In total, 95% of stimulus locations were located within the 95% limits of agreement and linear regression on the differences in sensitivities showed no statistically significant proportional bias (t = 1.713, p = 0.09). Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
CONCLUSION


The clinical examination of SPARK yields a sensitivity profile similar to SITA but in a faster examination time. The lower threshold variability of SPARK may be as a result of data smoothing in the threshold estimation process.",2020,"Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
","['normal subjects', '83 normal subjects each underwent two visual field examinations with SITA and SPARK on two separate occasions on a randomly selected eye']",[],['mean sensitivities of SITA Standard and SPARK Precision'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",83.0,0.0690914,"Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
","[{'ForeName': 'Say Kiang', 'Initials': 'SK', 'LastName': 'Foo', 'Affiliation': 'SEGi University, Faculty of Optometry & Vision Sciences, Petaling Jaya, Malaysia.'}, {'ForeName': 'Robert Peter', 'Initials': 'RP', 'LastName': 'Cubbidge', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Heitmar', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}]",European journal of ophthalmology,['10.1177/1120672120926455']
1912,32468956,"Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study.","PURPOSE


Pembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC.
METHODS


Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided  P  = .0048 for PFS and .0128 for OS.
RESULTS


Of the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023). Twelve-month PFS estimates were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. Although pembrolizumab plus EP prolonged OS, the significance threshold was not met (HR, 0.80; 95% CI, 0.64 to 0.98;  P  = .0164). Twenty-four-month OS estimates were 22.5% and 11.2%, respectively. ORR was 70.6% in the pembrolizumab plus EP group and 61.8% in the placebo plus EP group; the estimated proportion of responders remaining in response at 12 months was 19.3% and 3.3%, respectively. In the pembrolizumab plus EP and placebo plus EP groups, respectively, any-cause adverse events were grade 3-4 in 76.7% and 74.9%, grade 5 in 6.3% and 5.4%, and led to discontinuation of any drug in 14.8% and 6.3%.
CONCLUSION


Pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC.",2020,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","['453 participants', 'patients with ES-SCLC', 'patients with small-cell lung cancer (SCLC', 'Extensive-Stage Small-Cell Lung Cancer', 'Eligible patients', 'patients with previously untreated extensive-stage (ES) SCLC']","['Pembrolizumab or Placebo Plus Etoposide and Platinum', 'pembrolizumab plus EP', 'placebo plus EP', 'Pembrolizumab plus EP', 'pembrolizumab 200 mg once every 3 weeks or saline placebo', 'pembrolizumab plus EP and placebo plus EP', 'Pembrolizumab monotherapy', 'pembrolizumab plus etoposide and platinum (EP) with placebo plus EP']","['PFS', 'Objective response rate (ORR) and duration of response', 'toxicities', 'ORR', 'progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",453.0,0.588583,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","[{'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Rudin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navarro', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Gottfried', 'Affiliation': 'Meir Medical Center, Kfar-Saba, Israel.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Hetényi Géza Kórház Onkológiai Központ, Szolnok, Hungary.'}, {'ForeName': 'Parneet K', 'Initials': 'PK', 'LastName': 'Cheema', 'Affiliation': 'William Osler Health System, University of Toronto, Brampton, Ontario, Canada.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Wollner', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Orlandi', 'Affiliation': 'Oncología-Health and Care, Santiago, Chile.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Istanbul Medeniyet University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Kalemkerian', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ebiana', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00793']
1913,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE


Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients.
MATERIAL AND METHODS


A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end).
RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
CONCLUSIONS


This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869']
1914,32464420,Whole egg consumption increases plasma choline and betaine without affecting TMAO levels or gut microbiome in overweight postmenopausal women.,"As a crucial part of the symbiotic system, the gut microbiome is metabolically connected to many diseases and conditions, including cardiovascular diseases (CVD). Trimethylamine (TMA) is produced by gut bacteria from dietary choline, betaine, or L-carnitine, and is then converted in the liver to Trimethylamine N-oxide (TMAO), which in turn affects hepatic and intestinal lipid metabolism. Circulating TMAO is positively associated with CVD risk. Because eggs are rich in choline, it has been speculated that their consumption may increase plasma TMAO. In this study, we hypothesized that 2 eggs per day increases plasma TMAO level by altering gut microbiome composition in mildly hypercholesterolemic postmenopausal women. In this randomized, cross-over study, 20 overweight, postmenopausal women were given 2 whole eggs and the equivalent amount of yolk-free substitute as breakfast for 4 weeks, in randomized order, with a 4-week washout in between. Fasting blood draws and stool were collected at the beginning and end of each treatment period. Plasma TMAO, choline, betaine and other metabolites were analyzed using LC/MS, while gut microbiome composition was analyzed using 16S amplicon sequencing. Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments. Gut microbiome composition showed large inter-individual variability at baseline and in response to the treatments. The consumption of 2 eggs per day in overweight, postmenopausal mildly hypercholesterolemic women significantly increased plasma choline and betaine, but did not increase plasma TMAO or alter gut microbiome composition.",2020,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","['mildly hypercholesterolemic postmenopausal women', 'overweight postmenopausal women', '20 overweight, postmenopausal women']",['Trimethylamine (TMA'],"['plasma TMAO', 'plasma TMAO level', 'Plasma TMAO, choline, betaine and other metabolites', 'Plasma choline and betaine', 'Fasting blood draws and stool', 'TMAO level', 'plasma choline and betaine', 'plasma TMAO or alter gut microbiome composition']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0077172', 'cui_str': 'trimethylamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0381708,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bardagjy', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: asteve@ucdavis.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: xctang@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: romisacchi@gmail.com.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Randolph', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: jmrandolph@ucdavis.edu.'}, {'ForeName': 'Francene M', 'Initials': 'FM', 'LastName': 'Steinberg', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: fmsteinberg@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.04.002']
1915,32473084,"A randomized, single-blinded, vehicle-controlled study of a topical active blend in the treatment of androgenetic alopecia.","Αndrogenetic alopecia (AGA) is the most common hair disorder, affecting approximately 50% of men and women. A topical lotion that contains two patented formulas (Redensyl and Sepicontrol A5), has been introduced as an alternative approach to standard therapies for AGA. Forty-four patients with AGA were randomized either to apply the active lotion or the vehicle, twice daily for 24 weeks. Subjects were evaluated at 0, 12, and 24 weeks by clinical examination, photographic documentation, quality of life evaluation (DLQI), and trichogram (anagen-to-telogen ratio). Forty-one patients, 18 males and 23 females, completed the study. Among patients receiving active treatment (n = 26), 7.7% had great improvement, 73.1% had moderate improvement, and 19.2% remained stable. The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (P < .001), while the DLQI improved from 4 to 3, respectively (P < .001). The median anagen-to-telogen ratio increased from 2.25 to 4.00 to 6.02 at weeks 0, 12, and 24, respectively. No significant adverse events were reported. This new topical active blend is effective in the treatment of AGA, with high degree of patients' satisfaction, improvement of quality of life, and an excellent safety profile. Thus, it may represent a useful alternative therapeutic approach for AGA.",2020,"The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (p<0.001), while the DLQI improved from 4 to 3, respectively (p<0.001).","['Forty-four patients with AGA', 'Forty-one patients, 18 males and 23 females', 'androgenetic alopecia']",['active lotion'],"['median self-assessment score', 'DLQI', 'clinical examination, photographic documentation, quality of life evaluation (DLQI), and trichogram (anagen to telogen ratio', 'adverse events', 'median anagen to telogen ratio']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0519989', 'cui_str': 'Hair pluck test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.0689808,"The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (p<0.001), while the DLQI improved from 4 to 3, respectively (p<0.001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Katoulis', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Aikaterini I', 'Initials': 'AI', 'LastName': 'Liakou', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Koumaki', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Efstratios', 'Initials': 'E', 'LastName': 'Vakirlis', 'Affiliation': 'Department of Dermatology and Venereology, Aristotle University of Thessaloniki, Skin and Venereal Diseases Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Andreas G', 'Initials': 'AG', 'LastName': 'Tsantes', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Mortaki', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Bozi', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Demetrios', 'Initials': 'D', 'LastName': 'Ioannides', 'Affiliation': 'Department of Dermatology and Venereology, Aristotle University of Thessaloniki, Skin and Venereal Diseases Hospital, Thessaloniki, Greece.'}]",Dermatologic therapy,['10.1111/dth.13734']
1916,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND


In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion.
OBJECTIVES


The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population.
METHODS


A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline.
RESULTS


During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters.
CONCLUSION


These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983']
1917,32473865,A prospective randomized controlled clinical investigation comparing two post-operative wound dressings used after elective hip and knee replacement; Mepilex® Border Post-Op versus Aquacel® surgical.,"BACKGROUND


Post-operative wound complications, including blistering and surgical site infections, can increase recovery times, costs associated with hospital stay and morbidity.
AIM


To compare two post-operative wound dressings (Mepilex Border Post-Op and Aquacel Surgical), in patients undergoing elective hip or knee arthroplasty.
METHODS


International, open-label, prospective, superiority, multicentre, randomised, parallel-group, controlled trial. Primary outcome was dressing failure, a composite endpoint assessing four factors weighted from highest to lowest in relation to the risk of surgical site infection.
RESULTS


Mepilex Border Post-Op was comparable or superior to Aquacel® Surgical in all parameters investigated. Dressing failure rates, skin redness, itching under the dressing, pain during dressing removal and number of patients requiring a dressing change were low in both groups. Mepilex® Border Post-Op outperformed Aquacel Surgical for ease of application (p<0.0001) and removal (p<0.0001), ability to handle blood (p<0.0001), prevention of dressing residuals (p=0.0167), patient satisfaction of wearing the dressing during rehabilitation training (p=0.0037) and patients' overall experience with the dressing (P=0.0025).
CONCLUSION


Both dressings performed well in terms of minimizing post-operative wound complications. However, in relation to clinician satisfaction, minimization of pain and facilitation of patient comfort, Mepilex® Border Post-Op outperformed Aquacel Surgical.",2020,"Mepilex® Border Post-Op outperformed Aquacel Surgical for ease of application (p<0.0001) and removal (p<0.0001), ability to handle blood (p<0.0001), prevention of dressing residuals (p=0.0167), patient satisfaction of wearing the dressing during rehabilitation training (p=0.0037) and patients' overall experience with the dressing (P=0.0025).
",['patients undergoing elective hip or knee arthroplasty'],"['elective hip and knee replacement; Mepilex® Border Post-Op versus Aquacel® surgical', 'operative wound dressings (Mepilex Border Post-Op and Aquacel Surgical']","['risk of surgical site infection', 'dressing failure', 'Dressing failure rates, skin redness, itching under the dressing, pain during dressing removal and number of patients requiring a dressing change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0967370', 'cui_str': 'Aquacel'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0663202,"Mepilex® Border Post-Op outperformed Aquacel Surgical for ease of application (p<0.0001) and removal (p<0.0001), ability to handle blood (p<0.0001), prevention of dressing residuals (p=0.0167), patient satisfaction of wearing the dressing during rehabilitation training (p=0.0037) and patients' overall experience with the dressing (P=0.0025).
","[{'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Beele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van Overschelde', 'Affiliation': 'AZ Maria Middelares, Ghent, Belgium.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Olivecrona', 'Affiliation': 'Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Smet', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium. Electronic address: Steven.Smet@uzgent.be.'}]",International journal of orthopaedic and trauma nursing,['10.1016/j.ijotn.2020.100772']
1918,32473901,Aflibercept Reduces Retinal Hemorrhages and Intravitreal Microvascular Abnormalities But Not Venous Beading: Secondary Analysis of the CLARITY Study.,"PURPOSE


Approximately 50% of patients receiving anti-vascular endothelial growth factor (VEGF) therapy show significant improvement in diabetic retinopathy severity score (DRSS), in particular at DRSS level 47 to 53 (moderately severe to severe nonproliferative diabetic retinopathy). Level 47 to 53 consists of 3 main features: deep hemorrhages (DH), venous beading (VB), and intraretinal microvascular abnormalities (IRMAs). It is unclear whether these features respond to anti-VEGF therapies differently.
DESIGN


Post hoc analysis of Intravitreal Aflibercept versus Panretinal Photocoagulation in Patients with Proliferative Diabetic Retinopathy (CLARITY) study.
PARTICIPANTS


Treatment-naïve participants randomized to intravitreal aflibercept.
METHODS


We reanalyzed the fundus images at baseline, week 12, and week 52 to assess the changes of the 3 main features in DRSS level 47 to 53 in those patients who were treatment naïve and had received aflibercept.
MAIN OUTCOME MEASURES


Changes in DH, VB, and IRMA after aflibercept therapy at weeks 12 and 52.
RESULTS


Fifty-five treatment-naïve eyes at baseline that received aflibercept were included in the study. Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12. From 12 weeks, 32 eyes that had received injections showed improved or stable DH compared with 7 eyes that did not receive injections, and DH deteriorated in 6 eyes with no further injections compared with 4 eyes that had received more injections (P = 0.0072). Similarly, 15 eyes that continued to receive injections from week 12 showed improved or stable IRMA compared with 4 who did not receive injections (P = 0.006). Worsening of IRMA was seen in 5 eyes with no further injections compared with 4 eyes that continued to receive injections. The improvements in DH and IRMA are more likely to be maintained if less than 16 weeks have elapsed since the last anti-VEGF injection.
CONCLUSIONS


Aflibercept seems to improve DH and IRMA after just 3 injections. As soon as the frequency of injections were reduced, DH and IRMA can deteriorate again. It is unclear whether these results can be translated to patients without PDR.",2020,Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12.,"['Fifty-five treatment-naïve eyes at baseline that received', 'Patients with Proliferative Diabetic Retinopathy (CLARITY) study', 'patients without PDR']","['anti-vascular endothelial growth factor (VEGF) therapy', 'Panretinal Photocoagulation', 'aflibercept', 'intravitreal aflibercept', 'Aflibercept', 'Intravitreal Aflibercept']","['hemorrhages (DH), venous beading (VB), and intraretinal microvascular abnormalities (IRMAs', 'Severe DH and severe IRMA', 'Worsening of IRMA', 'stable DH', 'Retinal Hemorrhages and Intravitreal Microvascular Abnormalities', 'stable IRMA', 'Changes in DH, VB, and IRMA', 'diabetic retinopathy severity score (DRSS', 'DH and IRMA']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C2939143', 'cui_str': 'Retinal veins beaded'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021073', 'cui_str': 'Immunoradiometric Assays'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035317', 'cui_str': 'Retinal hemorrhage'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",6.0,0.0642177,Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pearce', 'Affiliation': 'Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom. Electronic address: liz.pearce@boehringer-ingelheim.com.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Boehringer Ingelheim International GmBH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.003']
1919,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978']
1920,32473959,A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers.,"Few trial data are available concerning the impact of personalised cancer risk information on behaviour. This study assessed the short-term effects of providing personalised cancer risk information on cancer risk beliefs and self-reported behaviour. We randomised 1018 participants, recruited through the online platform Prolific, to either a control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice. The primary outcome was change from baseline in computed risk relative to an individual with a recommended lifestyle (RRI) 1  at three months. Secondary outcomes included: health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction. After three months there were no between-group differences in change in RRI (p = 0.71). At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group. The increases in accuracy and conviction were only seen in individuals with high numeracy and low baseline conviction, respectively. These findings suggest that personalised cancer risk information alongside lifestyle advice can increase short-term risk accuracy and conviction without increasing worry or anxiety but has little impact on health-related behaviour. Trial registration: ISRCTN17450583. Registered 30 January 2018.",2020,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","['1018 participants, recruited through the online platform Prolific, to either a']","['control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice', 'personalised cancer risk information', 'online risk information and lifestyle advice']","['computed risk relative to an individual with a recommended lifestyle (RRI', 'accuracy and conviction', 'health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction', 'accuracy of absolute risk perception', 'absolute and comparative risk conviction', 'change in RRI', 'intention to increase fruit and vegetables', 'cancer risk beliefs and self-reported behaviour']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1547273', 'cui_str': 'Preventable'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",1018.0,0.105156,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","[{'ForeName': 'Golnessa', 'Initials': 'G', 'LastName': 'Masson', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: gh453@medschl.cam.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: kmills@medschl.cam.ac.uk.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge CB2 0QQ, UK. Electronic address: stephen.sharp@mrc-epid.cam.ac.uk.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'National Cancer Institute, Rockville, MD, USA. Electronic address: kleinwm@mail.nih.gov.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: srs34@medschl.cam.ac.uk.'}, {'ForeName': 'Juliet A', 'Initials': 'JA', 'LastName': 'Usher-Smith', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: jau20@medschl.cam.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106154']
1921,32476277,A comparative study of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis.,"AIM


PF-06438179/GP1111 (PF-SZ-IFX) is a biosimilar of reference infliximab (Remicade ®  ). This analysis compared the efficacy of PF-SZ-IFX and reference infliximab sourced from the European Union (IFX-EU) in patient subgroups from a randomized, comparative study of PF-SZ-IFX versus IFX-EU.
METHODS


Patients with rheumatoid arthritis were randomized 1:1 to PF-SZ-IFX (n = 324) or IFX-EU (n = 326); study drug (3 mg/kg) was administered intravenously at weeks 0, 2, and 6, then every 8 weeks thereafter. Subgroup analyses of efficacy endpoints such as American College of Rheumatology criteria for ≥20% clinical improvement (ACR20), change in high-sensitivity C-reactive protein (hs-CRP), and change in Disease Activity Score in 28 joints, four components based on hs-CRP (DAS28-CRP) at weeks 14 and 30 were performed by age, gender, race, region, immunogenicity status, and treatment history.
RESULTS


Overall, ACR20 response rates as well as changes in DAS28-CRP and hs-CRP at week 14 were similar between PF-SZ-IFX and IFX-EU within the subgroups of age, gender, race, region, treatment history, and immunogenicity status. Results to week 30 support overall similarity in efficacy between the two treatment arms in all subgroups.
CONCLUSION


Overall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status. The efficacy results from these subgroup analyses were aligned with the previously described results for the overall population up to week 30.",2020,"Overall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status.","['patients with moderate to severe active rheumatoid arthritis', 'n\xa0=\xa0326', 'Patients with rheumatoid arthritis']","['IFX-EU', 'PF-SZ-IFX and reference infliximab', 'PF-06438179/GP1111', 'PF-06438179/GP1111 (PF-SZ-IFX', 'infliximab', 'PF-SZ-IFX']","['American College of Rheumatology criteria for ≥20% clinical improvement (ACR20), change in high-sensitivity C-reactive protein (hs-CRP), and change in Disease Activity Score', 'Overall, ACR20 response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0550322,"Overall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status.","[{'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Uechi', 'Affiliation': 'Division of Rheumatology, Tomishiro Central Hospital, Okinawa, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Abud-Mendoza', 'Affiliation': 'Rheumatology Research Unit, Faculty of Medicine, Central Hospital Dr. Ignacio Morones Prieto, Universidad Autónoma de San Luis Potosí, San Luis, Mexico.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Kamei', 'Affiliation': 'Inflammation and Immunology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Tsugumi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Inflammation and Immunology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Ponce de Leon', 'Affiliation': 'Inflammation and Immunology, Latin America Medical Affairs, Pfizer Inc, Lima, Peru.'}, {'ForeName': 'Muhammad I', 'Initials': 'MI', 'LastName': 'Rehman', 'Affiliation': 'Clinical Development, Pfizer Inc, Andover, MA, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Global Biometrics and Data Management, Pfizer Inc, La Jolla, CA, USA.'}, {'ForeName': 'Sebastiao C', 'Initials': 'SC', 'LastName': 'Radominski', 'Affiliation': 'Rheumatology Service, Clinical Hospital, Universidade Federal do Paraná, Curitiba, Brazil.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13846']
1922,32449505,The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic.
OBJECTIVE


The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem.
METHODS


This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire.
RESULTS


This study was approved by the regional ethics committee (Île de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020.
CONCLUSIONS


The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17232.",2020,Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients.,"['patients with chronic disease, including cancer', 'Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy', 'lung and digestive cancer patients', 'breast cancer patients', 'digestive or lung cancer patients']","['chemotherapy', 'Foot reflexology sessions', 'foot reflexology', 'conventional care with foot reflexology and conventional care without foot reflexology']","['Cancer Quality of Life Questionnaire - Core 30 items, Hospital and Anxiety Depression Scale and Body Image Questionnaire', 'quality of life, anxiety, and self-esteem', 'nausea and vomiting', 'severity and frequency of chemotherapy-induced nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451107', 'cui_str': 'Depression anxiety scale'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}]",70.0,0.0859635,Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients.,"[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Murat-Ringot', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Pierre Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Chauvenet', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rentler', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Subtil', 'Affiliation': 'Centre de Coordination en Cancérologie, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Schott', 'Affiliation': 'HESPER EA7425, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Preau', 'Affiliation': 'Laboratoire GREPS EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piriou', 'Affiliation': 'HESPER EA7425, Université Lyon 1, Lyon, France.'}]",JMIR research protocols,['10.2196/17232']
1923,32450102,Prevalence of microvascular and macrovascular disease in the Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) Study cohort.,"AIMS


The Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) trial is a randomized clinical trial comparing glycemic effects of four diabetes medications added to metformin in type 2 diabetes (T2D). Microvascular and macrovascular diseases are secondary outcomes. We evaluated the prevalence and risk factor relationships for microvascular and macrovascular complications in the GRADE cohort at study entry.
METHODS


Complication prevalence and risk factors were analyzed based on data from screening in all consenting participants meeting GRADE eligibility. Logistic regression and Z-statistics were used to assess risk factor relationships with complications.
RESULTS


We enrolled 5047 T2D participants [mean age 57 years; 36% female; mean known T2D duration 4 years (all < 10 years); mean HbA1c 8.0% (∼64 mmol/mol) at screening]. Urinary albumin/creatinine ratio (ACR) ≥ 30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%. Myocardial infarction ascertained by self-report or electrocardiogram was present in 7.3%, and self-reported history of stroke in 2.0%.
CONCLUSIONS


In the GRADE cohort with < 10 years of T2D and a mean HbA1c of 8.0%, diabetes complications were present in a substantial fraction of participants, more so than might otherwise have been expected.",2020,Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%.,"['5047 T2D participants [mean age 57 years; 36% female; mean knownT2D duration 4 years (all<10 years); mean', 'Diabetes ', 'type 2 diabetes (T2D']",['metformin'],"['peripheral neuropathy', 'diabetes complications', 'Myocardial infarction ascertained by self-report or electrocardiogram', 'Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram', 'cardiovascular autonomic neuropathy']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy'}]",5047.0,0.0726804,Urinary albumin/creatinine ratio (ACR) ≥30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%.,"[{'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, United States. Electronic address: grademail@bsc.gwu.edu.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Cincinnati College of Medicine & Endocrine Section, Cincinnati VA Medical Center, Cincinnati OH, United States.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Division of Endocrinology and Fleischer Institute for Diabetes & Metabolism, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Division of Diabetes, Endocrinology & Metabolism, University of Nebraska College of Medicine, Omaha, NE, United States.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'M Sue', 'Initials': 'MS', 'LastName': 'Kirkman', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, United States.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Pettus', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of California, San Diego, CA, United States.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Seaquist', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, United States.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention and Department of Internal Medicine-Cardiology Section, Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Schroeder', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, United States.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108235']
1924,32451010,"Effects of auricular acupressure on the quality of sleep and anxiety in patients undergoing cardiac surgery: A single-blind, randomized controlled trial.","AIM


This study aimed to evaluate the effects of auricular acupressure (AA), a non-invasive type of reflexotherapy, on sleep quality and anxiety in patients after cardiac surgery.
BACKGROUND


Sleep disturbances and anxiety hinder the recovery of patients after cardiac surgery; thus, appropriate and adequate nursing interventions must be pursued. AA is a complementary therapy suitable for patients with limited pharmacological therapy options.
METHOD


A single-blind, randomized controlled trial with a pretest-posttest control group design was applied. The study consisted of 42 patients, comprising an experimental group (n = 21) and a control group (n = 21). AA was applied for six days per trial for a total of 2 trials, while sleep (sleep score, sleep satisfaction) and anxiety (state, trait) were measured at three time points (pre-op, 7 days post-op, and 14 days post-op).
RESULTS


The sleep and sleep satisfaction scores of the experimental group were significantly higher than those of the control group. No significant difference was found in anxiety state/trait between the two groups.
CONCLUSIONS


We conclude that AA is a safe, effective, noninvasive, and low-risk nursing intervention that can improve sleep quality in patients after cardiac surgery.",2020,The sleep and sleep satisfaction scores of the experimental group were significantly higher than those of the control group.,"['patients after cardiac surgery', 'patients undergoing cardiac surgery', 'patients with limited pharmacological therapy options', '42 patients, comprising an experimental group (n\xa0=\xa021) and a control group (n\xa0=\xa021']","['reflexotherapy', 'auricular acupressure (AA', 'auricular acupressure']","['sleep and sleep satisfaction scores', 'sleep (sleep score, sleep satisfaction) and anxiety (state, trait', 'sleep quality and anxiety', 'quality of sleep and anxiety', 'sleep quality', 'anxiety state/trait']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034946', 'cui_str': 'Reflex Therapy'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",42.0,0.0754569,The sleep and sleep satisfaction scores of the experimental group were significantly higher than those of the control group.,"[{'ForeName': 'Yun Yi', 'Initials': 'YY', 'LastName': 'Bang', 'Affiliation': 'Department of Nursing, KyungBok University, Gyeonggi-do, Republic of Korea. Electronic address: yybang@kbu.ac.kr.'}, {'ForeName': 'Hyojung', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, Republic of Korea. Electronic address: hyojungp@ewha.ac.kr.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151269']
1925,32451161,TOPS - a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan.,"BACKGROUND


This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS).
OBJECTIVES


TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP.
METHODS


TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test.
DISCUSSION


This paper will provide a detailed description of the planned analyses for the TOPS trial.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12615000939594).",2020,"Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression.",['people who have recently recovered from an episode of LBP'],"['exercise and education classes', 'TOPS', 'exercise and education', 'physical therapist-led exercise and education program for 12 weeks or minimal intervention']","['survival curves', 'recurrence of low back pain (LBP', 'recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day', 'days to recurrence of an episode of LBP', 'Hazard ratios (HRs) and median survival times', 'number of adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.294755,"Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression.","[{'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Ferreira', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia. Electronic address: giovanni.ferreira@sydney.edu.au.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Matthew Leigh', 'Initials': 'ML', 'LastName': 'Stevens', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Department of Health Professions, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Wisbey-Roth', 'Affiliation': 'Bounce Back Active Rehabilitation Systems, Sydney, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.05.001']
1926,32452208,"The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial.","BACKGROUND


Anterior cruciate ligament (ACL) tears are common knee injuries. Despite undergoing extensive rehabilitation after ACL reconstruction (ACLR), many patients have persistent quadriceps muscle weakness that limits their successful return to play and are also at an increased risk of developing knee osteoarthritis (OA). Human growth hormone (HGH) has been shown to prevent muscle atrophy and weakness in various models of disuse and disease but has not been evaluated in patients undergoing ACLR.
HYPOTHESIS


Compared with placebo treatment, a 6-week perioperative treatment course of HGH would protect against muscle atrophy and weakness in patients undergoing ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 19 male patients (aged 18-35 years) scheduled to undergo ACLR were randomly assigned to the placebo (n = 9) or HGH (n = 10) group. Patients began placebo or HGH treatment twice daily 1 week before surgery and continued through 5 weeks after surgery. Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers were measured at several time points through 6 months after surgery. Mixed-effects models were used to evaluate differences between treatment groups and time points, and as this was a pilot study, significance was set at  P  < .10. The Cohen  d  was calculated to determine the effect size.
RESULTS


HGH was well-tolerated, and no differences in adverse events between the groups were observed. The HGH group had a 2.1-fold increase in circulating insulin-like growth factor 1 over the course of the treatment period ( P  < .05;  d  = 2.93). The primary outcome measure was knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque by 29% compared with the placebo group ( P  = .05;  d  = 0.80). Matrix metalloproteinase-3 (MMP3), which was used as an indirect biomarker of cartilage degradation, was 36% lower in the HGH group ( P  = .05;  d  = -1.34). HGH did not appear to be associated with changes in muscle volume or patient-reported outcome scores.
CONCLUSION


HGH improved quadriceps strength and reduced MMP3 levels in patients undergoing ACLR. On the basis of this pilot study, further trials to more comprehensively evaluate the ability of HGH to improve muscle function and potentially protect against OA in patients undergoing ACLR are warranted.
REGISTRATION


NCT02420353 ( ClinicalTrials.gov identifier).",2020,Matrix metalloproteinase-3,"['patients undergoing ACLR', 'Patients Undergoing Anterior Cruciate Ligament Reconstruction', 'Anterior cruciate ligament (ACL) tears are common knee injuries', '19 male patients (aged 18-35 years) scheduled to undergo ACLR', 'patients undergoing ACLR are warranted']","['extensive rehabilitation after ACL reconstruction (ACLR', 'Recombinant Human Growth Hormone', 'Placebo', 'Human growth hormone (HGH', 'Matrix metalloproteinase-3', 'placebo or HGH', 'HGH', 'placebo']","['quadriceps strength and reduced MMP3 levels', 'knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque', 'adverse events', 'Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers', 'circulating insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}]","[{'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",19.0,0.277985,Matrix metalloproteinase-3,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Mendias', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Elizabeth R Sibilsky', 'Initials': 'ERS', 'LastName': 'Enselman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Olszewski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Gumucio', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edon', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Konnaris', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Carpenter', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tariq M', 'Initials': 'TM', 'LastName': 'Awan', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Jacobson', 'Affiliation': 'Department of Radiology, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Joel J', 'Initials': 'JJ', 'LastName': 'Gagnier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Barkan', 'Affiliation': 'Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520920591']
1927,32454356,Benefit-cost analysis of Promoting First Relationships®: Implications of victim benefits assumptions for return on investment.,"BACKGROUND


Child abuse and neglect (CAN) cost United States society $136 billion to $428 billion annually. Preventive interventions that reduce CAN may improve people's lives and generate economic benefits to society, but their magnitude is likely to vary greatly with assumptions about victim costs avoided through intervention.
OBJECTIVE


We examined the implications of different assumptions about avoided victim costs in a benefit-cost analysis of Promoting First Relationships® (PFR), a 10-session attachment and strengths-based home visiting intervention.
PARTICIPANTS AND SETTING


Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123).
METHODS


We monetized intervention effects on out-of-home placements and implicit effects on CAN and calculated net present values under three scenarios: (1) benefits from avoided system costs, (2) additional benefits from avoided tangible victim costs, and (3) additional benefits from avoided tangible and intangible quality-of-life victim costs. For scenarios 2 and 3, we varied the CAN effect size and estimated the effect size at which PFR was reliably cost beneficial.
RESULTS


PFR's societal net benefit ranged from $1 (scenario 1) to $5514 - $25,562 (scenario 2) and $7004 - $32,072 (scenario 3) (2014 USD). In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
CONCLUSIONS


PFR is cost beneficial assuming tangible victim costs are avoided by PFR. Research into the long-term health and economic consequences of reducing CAN in at-risk populations would contribute to comprehensive, accurate benefits models.",2020,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
",['Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123'],['Promoting First Relationships®'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}]",[],,0.0284117,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
","[{'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Kuklinski', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Ave. NE, Suite 401, Seattle, WA 98115, United States. Electronic address: mrk63@uw.edu.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Oxford', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mloxford@uw.edu.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Spieker', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: spieker@uw.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Lohr', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mjlohr@uw.edu.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'Center for The Study of Health and Risk Behavior, Department of Psychiatry, University of Washington, United States. Electronic address: cnbflem@uw.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104515']
1928,32458136,Arterial Hypertension in Children.,"Pharmacological treatment of arterial hypertension in children is mainly based on individual experience, but there is evidence that blocking the angiotensin system reduces systolic and diastolic blood when compared to placebo, and these drugs are safe to use for a short duration, also in children under 6 years of age. Blocking the angiotensin system either by angiotensin-converting enzyme inhibitors or by antagonizing the angiotensin 1 receptor is effective, but did not display a consistent dose-response relationship with escalating doses, but the effective doses are known. Calcium channel antagonists are effective antihypertensives in children, but the evidence is limited. Based on small-sized studies, beta-blockers modestly reduce systolic blood pressure, but have no significant effect on diastolic blood pressure compared to placebo. They act in combination to antagonize reflex tachycardia induced by vasodilators. The most commonly used antihypertensive agents are safe to use in short-term studies.",2020,"Based on small-sized studies, beta-blockers modestly reduce systolic blood pressure, but have no significant effect on diastolic blood pressure compared to placebo.","['children under 6\xa0years of age', 'Arterial Hypertension in Children']","['Calcium channel antagonists', 'placebo']","['diastolic blood pressure', 'systolic blood pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0454771,"Based on small-sized studies, beta-blockers modestly reduce systolic blood pressure, but have no significant effect on diastolic blood pressure compared to placebo.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rascher', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Friedrich-Alexander - University Erlangen-Nürnberg, Erlangen, Germany. wolfgang.rascher@uk-erlangen.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paech', 'Affiliation': 'Department for Pediatric Cardiology, University of Leipzig - Heart Center, Leipzig, Germany.'}]",Handbook of experimental pharmacology,['10.1007/164_2020_359']
1929,32462483,Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation-a randomized controlled trial.,"Preterm neonates with respiratory distress syndrome (RDS) are commonly treated with surfactant by intubate surfactant extubate (InSurE) technique. Mode of surfactant administration has evolved towards less invasive technique in the last few years. We randomised 58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive surfactant by InSurE or minimally invasive surfactant therapy (MIST). Non-invasive positive pressure ventilation (NIPPV) was used as primary respiratory support. The main objective was to compare the need of invasive mechanical ventilation (IMV) in first 72 h of life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality. We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32). No difference was observed in terms of hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality.Conclusion: There is no difference between MIST and InSurE in preterm neonates with RDS with NIPPV as a primary mode of respiratory support. Larger multicentre studies are needed to further explore differences in treatment failure and other secondary outcomes.Trial registration: www.ctri.nic.in id CTRI/2019/03/017992, registration date March 8, 2019. What is Known • InSurE is commonly used for many years for treatment of RDS in preterm neonates. • MIST has been introduced as a newer tool. What is New • MIST with feeding tube is comparable with InSurE in preterm infants with RDS in developing countries. •NIPPV can be used as primary respiratory support for MIST.",2020,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","['Preterm neonates with respiratory distress syndrome (RDS', 'preterm infants with RDS', 'preterm neonates with RDS with', '58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive', 'preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation']","['surfactant by intubate surfactant extubate (InSurE) technique', 'Minimally invasive surfactant therapy', 'invasive positive pressure ventilation (NIPPV', 'surfactant by InSurE or minimally invasive surfactant therapy (MIST', 'NIPPV']","['need of IMV', 'hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality', 'need of invasive mechanical ventilation (IMV', 'life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",58.0,0.200468,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","[{'ForeName': 'Bhupendra Kumar', 'Initials': 'BK', 'LastName': 'Gupta', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Anindya Kumar', 'Initials': 'AK', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Suchandra', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India. bijansaha18@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03682-9']
1930,32462607,Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO ®  and OTEMTO ®  Studies.,"INTRODUCTION


The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted.
METHODS


TONADO ®  1&2 and OTEMTO ®  1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg tiotropium (LAMA) or 5/5 µg tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI).
RESULTS


Overall, 151 patients received tiotropium; 148 received tiotropium/olodaterol. Mean differences from baseline with tiotropium/olodaterol versus tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P = 0.0004) for trough FEV 1 , - 2.675 (95% CI - 5.060, - 0.291; P = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P = 0.0001) for TDI. Patients were more likely to respond when treated with tiotropium/olodaterol versus tiotropium for trough FEV 1  (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P < 0.0001), SGRQ (OR 1.49, 95% CI 0.93, 2.40; P = 0.0980) and TDI (OR 2.81, 95% CI 1.71, 4.60; P < 0.0001). Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
CONCLUSION


In patients with COPD receiving only LAMA monotherapy, treatment escalation to tiotropium/olodaterol resulted in statistically significant and clinically relevant improvements in lung function, health status and breathlessness. These results support early therapy optimisation to dual bronchodilation with tiotropium/olodaterol in patients receiving tiotropium alone.
TRIAL REGISTRATION


TONADO ®  1 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431274). TONADO ®  2 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431287). OTEMTO ®  1 was registered in the US National Library of Medicine on 17 October 2013 (Clinicaltrials.gov: NCT01964352). OTEMTO ®  2 was registered in the US National Library of Medicine on 10 December 2013 (Clinicaltrials.gov: NCT02006732).",2020,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
","['®  2 was registered in the US National Library of Medicine on 10 December 2013', 'patients with COPD receiving only', 'Patients with COPD Receiving only LAMA at Baseline', 'patients receiving tiotropium alone', '®  1 was registered in the US National Library of Medicine on 17 October 2013', 'patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD', 'chronic obstructive pulmonary disease (COPD']","['tiotropium (LAMA) or 5/5\xa0µg tiotropium/olodaterol (LAMA/LABA', 'Tiotropium/Olodaterol', 'muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA', 'tiotropium/olodaterol', 'LAMA monotherapy', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['SGRQ', 'lung function, health status and breathlessness', ""trough forced expiratory volume in 1\xa0s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI""]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027470', 'cui_str': 'National Library of Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}]",,0.511381,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01373-3']
1931,32460679,Fruit supplementation reduces indices of exercise-induced muscle damage: a systematic review and meta-analysis.,"This systematic review and meta-analysis examined the effects of fruit supplements on indices of muscle damage and physical performance measures following muscle-damaging exercise protocols. The PEDro scale and Cochrane's risk of bias tool was used to critically appraise each study, whilst forest plots were generated to report on standardised mean differences (SMD) and  p -values. The studies employed a crossover-randomised design, or a randomised controlled placebo design, with measures compared between the supplement (SUPP) and placebo (PLA) conditions at 24 and 48 h following the muscle-damaging exercise protocols. Compared to the PLA condition, the SUPP condition exhibited significantly lower levels of indirect muscle damage markers ( p  = 0.02; I 2  = 44%), inflammatory markers ( p  = 0.03; I 2  = 45%) and oxidative stress ( p  < 0.001; I 2  = 58%), whilst antioxidant capacity was significantly increased ( p  = 0.04; I 2  = 82%) at 24 h post-exercise. The maximal isometric voluntary contraction was significantly greater for the SUPP condition than the PLA at 24 h ( p  < 0.001; I 2  = 81%) and 48 h ( p  < 0.001; 84%) post-exercise. Only a few studies reported on functional outcome measures (i.e. countermovement jump, cycling, sprint and running maximal oxygen uptake), and the findings appeared conflicting according to qualitative analyses. Fruit supplementation minimised the level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility during periods of EIMD. These findings demonstrate that fruit supplements could be used as recovery strategies from strenuous exercise sessions.",2020,"Fruit supplementation minimised the level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility during periods of EIMD.",[],"['supplement (SUPP) and placebo (PLA', 'Fruit supplementation', 'fruit supplements', 'placebo']","['maximal isometric voluntary contraction', 'levels of indirect muscle damage markers', 'oxidative stress', 'muscle damage and physical performance measures', 'antioxidant capacity', 'functional outcome measures (i.e., countermovement jump, cycling, sprint and running maximal oxygen uptake', 'inflammatory markers', 'level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility']",[],"[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",,0.0693269,"Fruit supplementation minimised the level of several biomarkers of muscle damage, inflammation and oxidative stress, whilst improved muscular contractility during periods of EIMD.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Connor', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}]",European journal of sport science,['10.1080/17461391.2020.1775895']
1932,32467339,Particle depletion of diesel exhaust restores allergen-induced lung-protective surfactant protein D in human lungs.,"RATIONALE


Exposure to air pollution is linked with increased asthma morbidity and mortality. To understand pathological processes linking air pollution and allergen exposures to asthma pathophysiology, we investigated the effect of coexposure to diesel exhaust (DE) and aeroallergen on immune regulatory proteins in human airways.
METHODS


Fourteen allergen-sensitised participants completed this randomised, double-blinded, cross-over, controlled exposure study. Each participant underwent four exposures (allergen-alone exposure, DE and allergen coexposure, particle-depleted DE (PDDE) and allergen coexposure, and sham exposure) on different order-randomised dates, each separated by a 4-week washout. Serum and bronchoalveolar lavage (BAL) were assayed for pattern recognition molecules, cytokines, chemokines and inflammatory mediators.
RESULTS


In human airways, allergen-alone exposure led to accumulation of surfactant protein D (SPD; p=0.02). Coexposure to allergen and DE did not elicit the same increase of SPD as did allergen alone; diesel particulate reduction restored allergen-induced SPD accumulation. Soluble receptor for advanced glycation end products was higher with particle reduction than without it. In the systemic circulation, there was a transient increase in SPD and club cell protein 16 (CC16) 4 hours after allergen alone. CC16 was augmented by PDDE, but not DE. % eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen. IL-5, SPD and % eosinophils in BAL were correlated with decreased FEV 1 .
CONCLUSION


Short-term coexposure to aeroallergen and DE alters immune regulatory proteins in lungs; surfactant levels are dependent on particle depletion.
TRIAL REGISTRATION NUMBER


NCT02017431.",2020,"% eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen.","['human airways', 'Fourteen allergen-sensitised participants', 'human lungs']","['four exposures (allergen-alone exposure, DE and allergen coexposure, particle-depleted DE (PDDE) and allergen coexposure, and sham exposure', 'coexposure to diesel exhaust (DE', 'diesel exhaust restores allergen-induced lung-protective surfactant protein D']","['CC16', 'asthma morbidity and mortality', 'IL-5, SPD and % eosinophils in BAL', 'Serum and bronchoalveolar lavage (BAL', 'SPD and club cell protein']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}]","[{'cui': 'C0225668', 'cui_str': 'Clara cell of bronchiole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.106351,"% eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen.","[{'ForeName': 'Min Hyung', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kevin Soon-Keen', 'Initials': 'KS', 'LastName': 'Lau', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Denise Jill', 'Initials': 'DJ', 'LastName': 'Wooding', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Don D', 'Initials': 'DD', 'LastName': 'Sin', 'Affiliation': ""Centre for Heart Lung Innovation, St. Paul's Hospital, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada carlsten@mail.ubc.ca.'}]",Thorax,['10.1136/thoraxjnl-2020-214561']
1933,32580919,A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children.,"BACKGROUND


Current influenza vaccine effectiveness (VE) improvement efforts focus on minimizing egg adaptation mutations during manufacture. This study compared immune response of two FDA-approved quadrivalent inactivated influenza vaccines in an unblinded randomized controlled trial.
METHODS


Participants were 144 community dwelling, healthy children/adolescents aged 4-20 years, randomized 1:1 in blocks of 4 to a vaccine grown in cell culture (ccIIV4 [Flucelvax®]; n = 85); or in egg medium (IIV4 [Fluzone ®]; n = 83). Blood was drawn at day 0 prevaccination and at day 28 (19-35 days) post vaccination. Hemagglutination inhibition (HI) assays against A/H1N1 and both B strains and microneutralization (MN) assays against egg-based and cell-based A/H3N2 strains were conducted. The primary outcome measure was seroconversion (day 28/day 0 titer ratio ≥ 4 with day 28 titer ≥ 40). Secondary outcomes were elevated titers (day 28 HI titer ≥ 1:110), geometric mean titers (GMTs) and mean fold rise (MFR) in titers. Outcomes were compared for 74 ccIIV4 recipients and 70 IIV4 recipients, and for those vaccinated and unvaccinated the previous year. Only the HI and MN laboratory analysis team was blinded to group assignment.
RESULTS


In this racially diverse (81% non-white) group of children with a median age of 14 years, baseline demographics did not differ between vaccine groups. At day 0, half or more in each vaccine group had elevated HI or MN titers. Low seroconversion rates (14%-35%) were found; they did not differ between groups. Among 2018-19 ccIIV4 recipients, those unvaccinated in the previous season showed significantly higher MFR against A/H1N1 and A/H3N2 cell-grown virus than the previously vaccinated. Similar results were found for MFR against B/Victoria among 2018-2019 IIV4 recipients.
CONCLUSION


In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses.
CLINICAL TRIALS NO


NCT03614975.",2020,"In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses.
","['≥\xa04 with day 28 titer', 'Participants were 144 community dwelling, healthy children/adolescents aged 4-20\xa0years', 'children']","['2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine', 'vaccine grown in cell culture (ccIIV4 [Flucelvax®]; n\xa0=\xa085); or in egg medium (IIV4 [Fluzone ®', 'FDA-approved quadrivalent inactivated influenza vaccines', 'Hemagglutination inhibition (HI) assays against A/H1N1 and both B strains and microneutralization (MN) assays']","['Low seroconversion rates', 'MFR against B/Victoria', 'antibody titers', 'titer ratio', 'elevated HI or MN titers', 'elevated titers (day 28 HI titer\xa0≥\xa01:110), geometric mean titers (GMTs) and mean fold rise (MFR', 'seroconversion (day 28/day 0']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",144.0,0.30326,"In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses.
","[{'ForeName': 'Krissy K', 'Initials': 'KK', 'LastName': 'Moehling', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Mary Patricia', 'Initials': 'MP', 'LastName': 'Nowalk', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: tnowalk@pitt.edu.'}, {'ForeName': 'Chyongchiou', 'Initials': 'C', 'LastName': 'Jeng Lin', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Alcorn', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA; Department of Immunology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Susick', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Burroughs', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Holiday', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Flannery', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.06.023']
1934,32469182,Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer.,"BACKGROUND


Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. The drug may have efficacy in patients with HER2-positive advanced gastric cancer.
METHODS


In an open-label, randomized, phase 2 trial, we evaluated trastuzumab deruxtecan as compared with chemotherapy in patients with HER2-positive advanced gastric cancer. Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including trastuzumab, were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan (6.4 mg per kilogram of body weight every 3 weeks) or physician's choice of chemotherapy. The primary end point was the objective response, according to independent central review. Secondary end points included overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety.
RESULTS


Of 187 treated patients, 125 received trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel). An objective response was reported in 51% of the patients in the trastuzumab deruxtecan group, as compared with 14% of those in the physician's choice group (P<0.001). Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]). The most common adverse events of grade 3 or higher were a decreased neutrophil count (in 51% of the trastuzumab deruxtecan group and 24% of the physician's choice group), anemia (38% and 23%, respectively), and decreased white-cell count (21% and 11%). A total of 12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee. One drug-related death (due to pneumonia) was noted in the trastuzumab deruxtecan group; no drug-related deaths occurred in the physician's choice group.
CONCLUSIONS


Therapy with trastuzumab deruxtecan led to significant improvements in response and overall survival, as compared with standard therapies, among patients with HER2-positive gastric cancer. Myelosuppression and interstitial lung disease were the notable toxic effects. (Funded by Daiichi Sankyo; DESTINY-Gastric01 ClinicalTrials.gov number, NCT03329690.).",2020,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","['12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee', 'patients with HER2-positive gastric cancer', 'patients with HER2-positive advanced gastric cancer', '187 treated patients', 'Previously Treated HER2-Positive Gastric Cancer', 'Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including']","['trastuzumab', 'trastuzumab deruxtecan', 'trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel', ""physician's choice of chemotherapy"", 'Trastuzumab Deruxtecan', 'chemotherapy']","['overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety', 'neutrophil count', 'Overall survival', 'objective response', 'anemia', 'Myelosuppression and interstitial lung disease', 'white-cell count', 'response and overall survival']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",187.0,0.240051,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hyun-Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kamio', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kojima', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sugihara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004413']
1935,32479328,Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population.,"BACKGROUND


Perinatal depression is a public health burden impacting mothers and their offspring. This study extended brief-Interpersonal Psychotherapy delivered during pregnancy by incorporating a postpartum attachment based dyadic-component to maintain mother's treatment gains and enhance the mother-infant relationship (called IPT-Dyad). The current report presents data from a pilot randomized controlled trial comparing IPT-Dyad to Enhanced Treatment as Usual (ETAU).
METHODS


Women, ages 18 and older, between 12-30 weeks gestation meeting criteria for a depressive disorder were eligible. Participants were randomized to either IPT-Dyad (n = 21) or ETAU (n = 21). Maternal and infant outcomes were assessed through one-year postpartum.
RESULTS


Participants were primarily African American (77%), single (80%), with low-incomes. Attrition was high in both groups (IPT-Dyad 30%; ETAU 40%). Depression scores improved from baseline in both groups and remained improved over the 12 month follow-up. There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
LIMITATIONS


The small sample size of this study was further reduced by attrition, despite efforts to maintain engagement. Reliance on self-report outcome measures is also a limitation.
CONCLUSIONS


IPT-Dyad may be a promising intervention for perinatal depression with potential benefit for mothers and babies. Treatment engagement and management of psychosocial needs were persistent challenges throughout the postpartum period. Further refinement of intervention content and schedule to better meet the needs and values of under-resourced mothers is needed. Earlier screening; better integration of care within OB settings; and delivering care in conjunction with social service resources may also improve outcomes.",2020,"There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
","['perinatal depression in a low-income population', 'Participants were primarily African American (77%), single (80%), with low-incomes', 'Women, ages 18 and older, between 12-30 weeks gestation meeting criteria for a depressive disorder were eligible']","['IPT-Dyad (n\xa0=\xa021) or ETAU', 'Interpersonal Psychotherapy', 'dyadic interpersonal psychotherapy']","['Depression scores', 'parenting stress, mother-infant interactions, and infant socioemotional functioning', 'Attrition']","[{'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",,0.157194,"There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
","[{'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA. Electronic address: slenze@wustl.edu.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Potts', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rodgers', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.084']
1936,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1937,32480409,"Dose-Response Relationships Between Gonadal Steroids and Bone, Body Composition, and Sexual Function in Aging Men.","CONTEXT


Most labs set the lower limit of normal for testosterone at the 2.5th percentile of values in young or age-matched men, an approach that does not consider the physiologic changes associated with various testosterone concentrations.
OBJECTIVE


To characterize the dose-response relationships between gonadal steroid concentrations and measures regulated by gonadal steroids in older men.
DESIGN, PARTICIPANTS, AND INTERVENTION


177 men aged 60 to 80 were randomly assigned to receive goserelin acetate plus either 0 (placebo), 1.25, 2.5, 5, or 10 grams of a 1% testosterone gel daily for 16 weeks or placebos for both medications (controls).
PRIMARY OUTCOMES


Changes in serum C-telopeptide (CTX), total body fat by dual energy X-ray absorptiometry, and self-reported sexual desire.
RESULTS


Clear relationships between the testosterone dosage (or the resulting testosterone levels) and a variety of outcome measures were observed. Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0 to 99, 100 to 199, 200 to 299, or 300 to 499 ng/dL, whereas increases in total body fat, subcutaneous fat, and thigh fat exceeded controls when testosterone levels were 0 to 99 or 100 to 199 ng/dL. Sexual desire and erectile function were indistinguishable from controls until testosterone levels were <100 ng/dL.
CONCLUSION


Changes in measures of bone resorption, body fat, and sexual function begin at a variety of testosterone concentrations with many outcome measures remaining stable until testosterone levels are well below the stated normal ranges. In light of this variation, novel approaches for establishing the normal range for testosterone are needed.",2020,Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0-99,"['Aging Men', '177 men ages 60-80', 'older men']","['testosterone gel daily for 16 weeks, or placebos', 'goserelin acetate plus either 0']","['Sexual desire and erectile function', 'serum CTX', 'total body fat, subcutaneous fat, and thigh fat exceeded controls when testosterone levels', 'bone resorption, body fat, and sexual function', 'serum C-telopeptide (CTX), total body fat by dual energy x-ray absorptiometry (DXA), and self-reported sexual desire', 'Bone, Body Composition, and Sexual Function']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700476', 'cui_str': 'Goserelin acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.0765777,Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0-99,"[{'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Finkelstein', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Sherri-Ann M', 'Initials': 'SM', 'LastName': 'Burnett-Bowie', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Darakananda', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Gentile', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Goldstein', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Prizand', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Krivicich', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Taylor', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Kendra E', 'Initials': 'KE', 'LastName': 'Wulczyn', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Elaine W', 'Initials': 'EW', 'LastName': 'Yu', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa318']
1938,32481760,"Oral Intake of Hydrangea serrata (Thunb.) Ser. Leaves Extract Improves Wrinkles, Hydration, Elasticity, Texture, and Roughness in Human Skin: A Randomized, Double-Blind, Placebo-Controlled Study.","Previously, we reported that the hot water extract of  Hydrangea serrata  leaves (WHS) and its active component, hydrangenol, possess in vitro and in vivo effects on skin wrinkles and moisturization. We conducted a randomized, double-blind, placebo-controlled trial to clinically evaluate the effect of WHS on human skin. Participants ( n  = 151) were randomly assigned to receive either WHS 300 mg, WHS 600 mg, or placebo, once daily for 12 weeks. Skin wrinkle, hydration, elasticity, texture, and roughness parameters were assessed at baseline and after 4, 8, and 12 weeks. Compared to the placebo, skin wrinkles were significantly reduced in both WHS groups after 8 and 12 weeks. In both WHS groups, five parameters (R1-R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks. Compared with the placebo, three parameters of skin elasticity, including overall elasticity (R2), net elasticity (R5), and ratio of elastic recovery to total deformation (R7), improved after 12 weeks of oral WHS (600 mg) administration. Changes in skin texture and roughness were significantly reduced in both WHS groups. No WHS-related adverse reactions were reported. Hence, WHS could be used as a health supplement for skin anti-aging.",2020,"In both WHS groups, five parameters (R1-R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks.","['human skin', 'Participants ( n  = 151']","['Placebo', 'WHS', 'oral WHS', 'WHS 300 mg, WHS 600 mg, or placebo', 'Hydrangea serrata (Thunb', 'placebo']","['Wrinkles, Hydration, Elasticity, Texture, and Roughness in Human Skin', 'Skin wrinkle, hydration, elasticity, texture, and roughness parameters', 'skin wrinkles', 'skin elasticity, including overall elasticity (R2), net elasticity (R5), and ratio of elastic recovery to total deformation (R7', 'adverse reactions', 'skin hydration', 'skin texture and roughness']","[{'cui': 'C3859811', 'cui_str': 'human skin preparation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1956097', 'cui_str': 'Wolf Hirschhorn syndrome'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0330862', 'cui_str': 'Hydrangea'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}]",151.0,0.277195,"In both WHS groups, five parameters (R1-R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks.","[{'ForeName': 'Da-Bin', 'Initials': 'DB', 'LastName': 'Myung', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Jeong-Hun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Kwang-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Hye Shin', 'Initials': 'HS', 'LastName': 'Ahn', 'Affiliation': 'Department of New Material Development, COSMAXBIO, Seongnam 13486, Korea.'}, {'ForeName': 'Yu-Kyong', 'Initials': 'YK', 'LastName': 'Shin', 'Affiliation': 'Department of New Material Development, COSMAXBIO, Seongnam 13486, Korea.'}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Song', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul 02447, Korea.'}, {'ForeName': 'Bo-Hyung', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul 02447, Korea.'}, {'ForeName': 'Kwang Hoon', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Global Medical Research Center, Seoul 06035, Korea.'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of New Material Development, COSMAXBIO, Seongnam 13486, Korea.'}, {'ForeName': 'Kyung-Tae', 'Initials': 'KT', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}]",Nutrients,['10.3390/nu12061588']
1939,32482433,Effects of Exercise and an Integrated Neuromuscular Inhibition Technique Program in the Management of Chronic Mechanical Neck Pain: A Randomized Controlled Trial.,"OBJECTIVE


The aim of this study was to evaluate the effect of adding the integrated neuromuscular inhibition technique (INIT) to therapeutic exercise (TE) in individuals with chronic mechanical neck pain (CMNP).
METHODS


In this 34-week, assessor-blind randomized controlled trial, 40 participants (men and women) with CMNP with active or latent myofascial trigger points on the neck muscles were divided into 2 groups. The participants followed 4 treatments per week for 10 weeks. The intervention group followed a TE program in combination with the INIT, whereas the control group followed the same program without the INIT. Both protocols were applied by physiotherapists. Pain, disability, pressure pain threshold, active range of motion, and health-related quality of life were evaluated before, during, and after the intervention, whereas patients were followed for 6 months after completion of treatment. Repeated-measures ANOVA was applied.
RESULTS


Both groups showed a significant improvement in all dependent measures after the intervention (P < .05). However, the intervention group showed greater improvement in the visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score, than the control group. In many of the above variables this improvement was seen from the second week and was maintained for 6 months after the intervention.
CONCLUSION


The results of this preliminary study suggest that the addition of the INIT to a TE program had a positive effect on pain, functionality, and the quality of life in individuals with CMNP.",2020,"However, the intervention group showed greater improvement in the visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score, than the control group.","['Chronic Mechanical Neck Pain', 'individuals with chronic mechanical neck pain (CMNP', '40 participants (men and women) with CMNP with active or latent myofascial trigger points on the neck muscles', 'individuals with CMNP']","['TE program in combination with the INIT, whereas the control group followed the same program without the INIT', 'integrated neuromuscular inhibition technique (INIT) to therapeutic exercise (TE', 'Exercise and an Integrated Neuromuscular Inhibition Technique Program']","['visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score', 'pain, functionality, and the quality of life', 'Pain, disability, pressure pain threshold, active range of motion, and health-related quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",40.0,0.0689753,"However, the intervention group showed greater improvement in the visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score, than the control group.","[{'ForeName': 'Dimitrios E', 'Initials': 'DE', 'LastName': 'Lytras', 'Affiliation': 'Laboratory of Ergophysiology, Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, Thermi Thessaloniki, Greece. Electronic address: lytrasde@gmail.com.'}, {'ForeName': 'Evaggelos I', 'Initials': 'EI', 'LastName': 'Sykaras', 'Affiliation': 'Laboratory of Ergophysiology, Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, Thermi Thessaloniki, Greece.'}, {'ForeName': 'Kosmas I', 'Initials': 'KI', 'LastName': 'Christoulas', 'Affiliation': 'Laboratory of Ergophysiology, Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, Thermi Thessaloniki, Greece.'}, {'ForeName': 'Ioannis S', 'Initials': 'IS', 'LastName': 'Myrogiannis', 'Affiliation': 'Laboratory of Hygiene-Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, University Campus, Thessaloniki, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Kellis', 'Affiliation': 'Laboratory of Neuromechanics, Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloníki, Agios Ioannis Serres, Greece.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.03.011']
1940,32491006,Controlled Study of Central Hemodynamic Changes in Inspiratory Exercise with Different Loads in Heart Failure.,"Background Inspiratory muscle weakness contributes to exercise intolerance and decreased quality of life in patients with heart failure. Studies with inspiratory muscle training show improvement in inspiratory muscle strength, functional capacity and quality of life. However, little is known about the central hemodynamic response (CHR) during inspiratory exercise (IE). Objective To evaluate CHR in a single IE session with different loads (placebo, 30% and 60%) in heart failure. Methods Randomized placebo-controlled clinical trial in patients with heart failure with reduced ejection fraction, functional class II and III. Twenty patients aged 65 ± 11 years completed a single session of inspiratory exercise, in 3 cycles of 15 minutes, with a 1-hour washout, involving loads of 30% (C30), 60% (C60) and placebo, using a linear load resistor (PowerBreathe Light). The noninvasive hemodynamic study was performed by cardiothoracic bioimpedance (Niccomo™ CardioScreen®). Statistical analysis was performed with Student's t-test and Pearson's correlation, and P≤0.05 was considered significant. Results An increase in heart rate (HR) was observed with C30 (64 ± 15 vs 69 ± 15 bpm; p = 0.005) and C60 (67 ± 14 vs 73 ± 14 bpm, p = 0.002). A decrease was observed in systolic volume (SV) with C30 (73 ± 26 vs 64 ± 20 ml; p = 0.004). Cardiac output (CO), on its turn, increased only with C60 (4.6 ± 1.5 vs 5.3 ± 1.7 l/min; p = -0.001). Conclusion When using the 60% load, in a single IE session, changes in CHR were observed. HR and CD increased, as did the Borg scales and subjective sensation of dyspnea. The 30% load reduced the SV. (Arq Bras Cardiol. 2020; 114(4):656-663).",2020,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","['patients with heart failure with reduced ejection fraction, functional class II and III', 'patients with heart failure', 'Twenty patients aged 65 ± 11 years completed a', 'Inspiratory Exercise with Different Loads in Heart Failure']","['placebo', 'single session of inspiratory exercise', 'inspiratory muscle training']","['quality of life', 'CHR', 'inspiratory muscle strength, functional capacity and quality of life', 'systolic volume (SV', 'HR and CD', 'heart failure', 'heart rate (HR', 'SV', 'subjective sensation of dyspnea', 'Cardiac output (CO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.0580409,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","[{'ForeName': 'Luana de Decco', 'Initials': 'LD', 'LastName': 'Marchese', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Chermont', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Warol', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Lucia Brandão de', 'Initials': 'LB', 'LastName': 'Oliveira', 'Affiliation': 'Clínica de Insuficiência Cardíaca, Centro Universitário Serra dos Órgãos, Teresópolis, RJ, Brasil.'}, {'ForeName': 'Sabrina Bernardez', 'Initials': 'SB', 'LastName': 'Pereira', 'Affiliation': 'Hospital do Coração, São Paulo, SP – Brazil'}, {'ForeName': 'Mônica', 'Initials': 'M', 'LastName': 'Quintão', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Evandro Tinoco', 'Initials': 'ET', 'LastName': 'Mesquita', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180375']
1941,32486385,A Phase 1 Study of mTORC1/2 Inhibitor BI 860585 as a Single Agent or with Exemestane or Paclitaxel in Patients with Advanced Solid Tumors.,"This phase 1 trial (NCT01938846) determined the maximum tolerated dose (MTD) of the mTOR serine/threonine kinase inhibitor, BI 860585, as monotherapy and with exemestane or paclitaxel in patients with advanced solid tumors. This 3+3 dose-escalation study assessed BI 860585 monotherapy (5-300 mg/day; Arm A), BI 860585 (40-220 mg/day; Arm B) with 25 mg/day exemestane, and BI 860585 (80-220 mg/day; Arm C) with 60-80 mg/m 2 /week paclitaxel, in 28-day cycles. Primary endpoints were the number of patients with dose-limiting toxicities (DLTs) in cycle 1 and the MTD. Forty-one, 25, and 24 patients were treated (Arms A, B, and C). DLTs were observed in four (rash ( n  = 2), elevated alanine aminotransferase/aspartate aminotransferase, diarrhea), four (rash ( n  = 3), stomatitis, and increased gamma-glutamyl transferase), and two (diarrhea, increased blood creatine phosphokinase) patients in cycle 1. The BI 860585 MTD was 220 mg/day (Arm A) and 160 mg/day (Arms B and C). Nine patients achieved an objective response (Arm B: Four partial responses (PRs); Arm C: Four PRs; one complete response). The disease control rate was 20%, 28%, and 58% (Arms A, B, and C). The most frequent treatment-related adverse events (AEs) were hyperglycemia (54%) and diarrhea (39%) (Arm A); diarrhea (40%) and stomatitis (40%) (Arm B); fatigue (58%) and diarrhea (58%) (Arm C). The MTD was determined in all arms. Antitumor activity was observed with BI 860585 monotherapy and in combination with exemestane or paclitaxel.",2020,The most frequent treatment-related adverse events (AEs) were hyperglycemia (54%) and diarrhea (39%),"['Patients with Advanced Solid Tumors', 'patients with advanced solid tumors']","['Exemestane or Paclitaxel', 'exemestane or paclitaxel', 'exemestane', 'week paclitaxel']","['diarrhea', 'disease control rate', 'Antitumor activity', 'elevated alanine aminotransferase/aspartate aminotransferase, diarrhea), four (rash ( n  = 3), stomatitis, and increased gamma-glutamyl transferase), and two (diarrhea, increased blood creatine phosphokinase', 'objective response', 'number of patients with dose-limiting toxicities (DLTs) in cycle 1 and the MTD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0853165', 'cui_str': 'Blood creatine phosphokinase'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}]",860585.0,0.0390057,The most frequent treatment-related adverse events (AEs) were hyperglycemia (54%) and diarrhea (39%),"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Medical Oncology Department, University of Milan, via G. Venezian, 1, 20133 Milan, Italy.'}, {'ForeName': 'Jean-Pascal H', 'Initials': 'JH', 'LastName': 'Machiels', 'Affiliation': ""Institut Roi Albert II, Service d'Oncologie Médicale, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Avenue Hippocrate 10, 200 Woluwe-Saint-Lambert, 1200 Brussels, Belgium.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Boggiani', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Via Antonio Gramsci 14, 43126 Parma, Italy.'}, {'ForeName': 'Sylvie W H', 'Initials': 'SWH', 'LastName': 'Rottey', 'Affiliation': 'Drug Research Unit Ghent, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, via G. Venezian, 1, 20133 Milan, Italy.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Laruelle', 'Affiliation': 'Institut Roi Albert II, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université catholique de Louvain, Avenue Hippocrate 10, 200 Woluwe-Saint-Lambert, 1200 Brussels, Belgium.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Salvagni', 'Affiliation': 'Policlinico S. Orsola Malphigi, via Giuseppe Massarenti, 13, 40138 Bologna, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Damian', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, via G. Venezian, 1, 20133 Milan, Italy.'}, {'ForeName': 'Lore D F', 'Initials': 'LDF', 'LastName': 'Lapeire', 'Affiliation': 'Drug Research Unit Ghent, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Via Antonio Gramsci 14, 43126 Parma, Italy.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dermine', 'Affiliation': 'Institut Roi Albert II, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université catholique de Louvain, Avenue Hippocrate 10, 200 Woluwe-Saint-Lambert, 1200 Brussels, Belgium.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ould-Kaci', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd, Ridgefield, CT 06877, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Braunger', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Rascher', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Hoefler', 'Affiliation': 'Staburo GmbH, Aschauer Str. 26b, 81549 Munich, Germany, on behalf of Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Gabriella L', 'Initials': 'GL', 'LastName': 'Mariani', 'Affiliation': 'Boehringer Ingelheim, via Giovanni Lorenzini, 8, 20139 Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cresta', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, via G. Venezian, 1, 20133 Milan, Italy.'}]",Cancers,['10.3390/cancers12061425']
1942,32459005,Treatment with Zoledronate Subsequent to Denosumab in Osteoporosis: a Randomized Trial.,"Discontinuing denosumab is associated with bone loss and possibly increased fracture risk. We investigated if treatment with zoledronate (ZOL) could prevent bone loss and if the timing of the ZOL infusion influenced the outcome. We report on a 2-year randomized, open label, interventional study including 61 patients with osteopenia, discontinuing denosumab after 4.6 ± 1.6 years. We administrated ZOL 6 months (6M group, n = 20) or 9 months (9M group, n = 20) after the last denosumab injection or when bone turnover had increased (OBS group, n = 21). We monitored the patients with DXA and bone turnover markers. Our primary endpoints were change in lumbar spine BMD (LSBMD) 6 months after ZOL and the proportion of patients who failed to maintain BMD. The study is ongoing (clinicaltrials.gov; NCT03087851). We included 61 participants and 59 patients completed follow-up 12 months after ZOL. Six months after ZOL, LSBMD had decreased significantly by (mean ± SE) 2.1% ± 0.9%, 4.3% ± 1.1%, and 3.0% ± 1.1% in the 6M, 9M, and OBS groups, respectively, and by 4.8% ± 0.7%, 4.1% ± 1.1%, and 4.7% ± 1.2% 12 months after ZOL in the 6M, 9M, and OBS groups, respectively (p < .02, no between-group differences). BMD loss above the least significant change was seen in all groups; at the spine: 6M, n = 6 (30%); 9M, n = 9 (45%); and OBS, n = 9 (47%); and at the total hip: 6M, n = 1 (5%); 9M, n = 5 (25%); and OBS, n = 2 (11%). In the 6M group p-crosslinked C-terminal telopeptide (p-CTX) decreased initially, but increased rapidly thereafter, and 6 months after ZOL, p-CTX was 0.60 ± 0.08 g/L. p-CTX increased rapidly in the 9M and OBS groups, was suppressed by ZOL but increased again thereafter; p-CTX was 0.47 ± 0.05 μg/L and 0.47 ± 0.05 μg/L in the 9M and OBS groups 6 months after ZOL, respectively. Incident vertebral fractures were seen in two women in the 9M group. Treatment with ZOL irrespective of the timing did not fully prevent loss of BMD in patients discontinuing denosumab. © 2020 American Society for Bone and Mineral Research.",2020,"Six months after zoledronate, LSBMD had decreased significantly by 2.1 ± 0.9% (mean ± SEM), 4.3 ± 1.1% and 3.0 ± 1.1% in the 6 M, 9 M and OBS groups, respectively and by 4.8 ± 0.7%, 4.1 ± 1.1%, and 4.7 ± 1.2% 12 months after zoledronate in the 6 M, 9 M and OBS groups, respectively (p < 0.02, no between group differences).","['61 participants and 59 patients completed follow-up 12\u2009months after zoledronate', 'patients with DXA and bone turnover markers', 'osteoporosis', '61 patients with osteopenia, discontinuing denosumab after 4.6\u2009±\u20091.6\u2009years']","['zoledronate', 'zoledronate subsequent to denosumab']","['BMD loss', 'LSBMD', 'lumbar spine BMD (LSBMD', 'bone loss', 'Incident vertebral fractures', 'loss of BMD', 'fracture risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",61.0,0.0298057,"Six months after zoledronate, LSBMD had decreased significantly by 2.1 ± 0.9% (mean ± SEM), 4.3 ± 1.1% and 3.0 ± 1.1% in the 6 M, 9 M and OBS groups, respectively and by 4.8 ± 0.7%, 4.1 ± 1.1%, and 4.7 ± 1.2% 12 months after zoledronate in the 6 M, 9 M and OBS groups, respectively (p < 0.02, no between group differences).","[{'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Sølling', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Harsløf', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4098']
1943,32459016,A randomized controlled study of 6% gabapentin topical formulation for chronic kidney disease-associated pruritus.,"BACKGROUND


Novel agents with good safety profiles are needed in the management of chronic kidney disease-associated pruritus (CKD-AP). This study aims to assess the efficacy and safety of topical gabapentin in the treatment of CKD-AP.
METHODS


The authors conducted a randomized, double-blind, vehicle-controlled study. The key inclusion criteria were: (i) patients on hemodialysis for at least 8 weeks, and (ii) a baseline visual analog scale (VAS) pruritus score ≥5. Patients were randomized into two groups. Topical 6% gabapentin was used in the experimental group while plain permeation cream was used for the control group. The primary endpoint was the mean change in pruritus scores using the VAS (MCPS-VAS) from baseline after 1 and 2 weeks of once daily application.
RESULTS


Thirty patients (15 per group) were included in the analysis. Treatment with 6% topical gabapentin resulted in significantly decreased mean pruritus scores at 1 week (mean score 2.7; range 0-5; P < 0.001) and 2 weeks (mean score 1.3, range 0-5; P < 0.001) from baseline (mean score 5.9; range 5-8). The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week. However, the MCPS-VAS of the experimental group (mean change -4.6; range 0-7) was significantly greater (P = 0.01) compared to control (mean change -2.6; range -1 to 5) after 2 weeks. There were no drug-related adverse events reported.
CONCLUSION


Our results suggest that short-term use of topical gabapentin may significantly decrease CKD-AP severity after 2 weeks with no reported acute adverse events.",2020,The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week.,"['chronic kidney disease-associated pruritus', 'Thirty patients (15 per group) were included in the analysis']","['gabapentin topical formulation', 'plain permeation cream', 'topical gabapentin', 'Topical 6% gabapentin']","['mean change in pruritus scores using the VAS (MCPS-VAS', 'CKD-AP severity', 'efficacy and safety', 'MCPS-VAS', 'baseline visual analog scale (VAS) pruritus score ≥5', 'mean pruritus scores']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",30.0,0.0514989,The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week.,"[{'ForeName': 'Terese Monette O', 'Initials': 'TMO', 'LastName': 'Aquino', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Karla Angela C', 'Initials': 'KAC', 'LastName': 'Luchangco', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Sanchez', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Vermen M', 'Initials': 'VM', 'LastName': 'Verallo-Rowell', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}]",International journal of dermatology,['10.1111/ijd.14953']
1944,32463593,Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects.,"Sildenafil citrate is approved to treat erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate that does not require swallowing or administration with fluids has been developed. The bioequivalence and bioavailability of sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets (50 mg) in an open-label, randomized crossover study. Healthy Chinese male subjects (n = 36) were allocated to 1 of 6 sildenafil citrate treatment sequences under fasted conditions, and plasma samples for determination of sildenafil concentrations were collected predose through 14 hours postdose. Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil AUC last  , C max  , and AUC inf  (ratio, 101.41%; 90%CI, 95.49%-107.70%; ratio, 93.55%; 90%CI, 84.15%-104.00%; and ratio, 101.03%; 90%CI, 94.80%-107.66%; respectively) were wholly contained within the bioequivalence acceptance range of 80% to 125%, indicating bioequivalence criteria were met. Relative bioavailability of sildenafil citrate ODT administered with water to the sildenafil citrate tablet (50 mg) administered with water was 97.10%, 91.43%, and 97.09% with respect to sildenafil AUC last  , C max  , and AUC inf  , respectively (90%CI, 91.43%-03.12%, 82.25%-101.65%, and 90.90%-103.71%, respectively). Both sildenafil citrate formulations were generally well tolerated in healthy Chinese men. Sildenafil citrate ODT administered without or with water was bioequivalent to or met bioequivalence criteria compared with conventional sildenafil citrate tablets administered with water under fasted conditions in healthy Chinese men, thus offering a convenient alternative method of oral administration.",2020,Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil,"['Healthy Chinese male subjects (n = 36', 'healthy Chinese men', 'Healthy Chinese Male Subjects']","['sildenafil citrate tablet', 'sildenafil citrate ODT', 'Sildenafil citrate ODT', 'conventional sildenafil citrate tablets', 'sildenafil AUC', 'sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets', 'sildenafil citrate formulations', 'Sildenafil citrate', 'sildenafil citrate', 'Sildenafil Citrate', 'sildenafil']","['Relative bioavailability', 'AUC last  , C max  , and AUC inf', 'Bioequivalence and Bioavailability', 'last  , C max  , and AUC inf']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",36.0,0.0744477,Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Peking University First Hospital, Institute of Clinical Pharmacology, Beijing, China.'}, {'ForeName': 'Bin-Yu', 'Initials': 'BY', 'LastName': 'Luo', 'Affiliation': 'Pfizer Inc, Shanghai, China.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'LaBadie', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Inc, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Pfizer Inc, Beijing, China.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Ernst', 'Affiliation': 'ExecuPharm, King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Penelope H', 'Initials': 'PH', 'LastName': 'Crownover', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Qinying', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.806']
1945,32460116,The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial.,"OBJECTIVES


Today all pregnant women are recommended to participate in moderate intensity aerobic and resistance-based physical activity/exercise ≥150 min/week. However, there are still controversies and scant knowledge on the role of regular exercise on delivery outcomes, including mode of delivery and length of active labour. In addition, nutritional counselling have often been examined together with exercise, which may independently effect the outcomes. Hence, the aims of the present study were to investigate the sole effect of supervised group exercise, including pelvic floor muscle training on course of labour and mode of delivery.
STUDY DESIGN


A single blind, randomized controlled trial, performed in the municipality of Oslo, Norway. Out of 105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7 ± 4.2) to study the effect regular aerobic exercise (60 min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7 ± 1.7) on labour outcomes (exercise: 43 and control: 47). Data were collected via standardized interviews and birth partographs from hospital records, reported on the postpartum visit (weeks after labour 7.6 ± 1.6). The primary investigator was unaware of the original randomization at the time of the interviews. The principal analysis was done on an intention to treat basis (ITT). For the planned subgroup analyses (per protocol), acceptable intervention adherence was defined as attending ≥ 80% of the recommended exercise program (≥ 19 exercise sessions).
RESULTS


There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT. Per protocol analyses, showed a shorter duration of total active labour in the exercise group (6.8 ± 5.5 h) than the control group (9.8 ± 5.4 h), with a mean between group difference of 3.1 h (95% CI 0.31-5.9, p = 0.029). Rate of normal vaginal delivery was 85.7% among adherent participants and 62.3% in the control group (p = 0.051).
CONCLUSIONS


Regular exercise during pregnancy decreased duration of total active labour and showed a trend towards more normal vaginal deliveries among participants who adhered to the prescribed program.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00617149.",2020,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","['60\u2009min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7\u2009±\u20091.7) on labour outcomes (exercise: 43 and control: 47', 'Today all pregnant women', '105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7\u2009±\u20094.2) to study the effect', 'municipality of Oslo, Norway']","['regular exercise training', 'Regular exercise', 'regular aerobic exercise', 'supervised group exercise, including pelvic floor muscle training']","['normal vaginal deliveries', 'duration of total active labour', 'shorter duration of total active labour', 'Rate of normal vaginal delivery', 'induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT', 'acceptable intervention adherence']","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",105.0,0.114603,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Associate Professor, Exercise Scientist, Norwegian School of Sports Sciences, Department of Sports Medicine, PO Box 4014, Ullevål Stadion, Oslo, Norway. Electronic address: lahaakstad@nih.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Professor, Exercise Scientist, Physical Therapist, Norwegian School of Sports Sciences, Department of Sports Medicine, Norway. Electronic address: kari.bo@nih.no.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.014']
1946,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND


Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary.
OBJECTIVE


To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning.
METHODS


A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied.
RESULTS


Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months.
CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929']
1947,32468719,Bioequivalence Study of 2 Capsule Formulations of Fingolimod 0.5 mg Assessing Both Parent Drug and Active Metabolite in New Zealand Healthy Subjects (Truncated Design).,"Fingolimod is indicated for the treatment of patients with the relapsing-remitting form of multiple sclerosis. The primary study objective was to evaluate the bioequivalence of a test formulation, 0.5 mg fingolimod HCl capsule (Lebrina, Asofarma Sociedad Anónima Industrial y Comercial, Argentina) relative to a reference formulation, 0.5 mg fingolimod capsule (Gilenya, Novartis Pharmaceutical, Australia). In a single-center, randomized, single-dose, single-blinded, 2-way crossover study, 33 New Zealand healthy subjects of both sexes were enrolled to receive a 0.5-mg dose of 3 capsules of each fingolimod formulation under fasting conditions, with a 42-day washout period between administrations. Additional pharmacokinetic information regarding its main active metabolite, fingolimod phosphate, was also provided. The point estimate and 90% confidence intervals of the ratios of maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours were 99.07 (95.83-102.41) and 97.64 (95.33-100.00) for fingolimod, and 95.60 (90.95-100.49) and 98.54 (96.19-100.96), for fingolimod phosphate. Primary parameters, maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours for fingolimod and fingolimod phosphate were found to have no significant difference when test and reference formulations were compared. Fingolimod and fingolimod phosphate of both formulations were within the accepted 90% confidence interval limits of 80.00% and 125.00%. No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated. Notwithstanding the primary conclusion of bioequivalence is focused on the measurement of the parent compound, compliance with the same criteria by the active metabolite reinforces the comparability between the pharmacokinetic profiles of both formulations (ClinicalTrials.gov Identifier: NCT03757338).",2020,No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated.,"['patients with the relapsing-remitting form of multiple sclerosis', '33 New Zealand healthy subjects of both sexes', 'New Zealand Healthy Subjects (Truncated Design']","['Fingolimod', '0.5 mg Assessing Both Parent Drug and Active Metabolite', 'fingolimod HCl capsule ']","['maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours for fingolimod and fingolimod phosphate', 'ratios of maximum concentration and area under the plasma concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0388087', 'cui_str': 'Fingolimod hydrochloride'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",33.0,0.0636992,No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated.,"[{'ForeName': 'Noelyn Anne', 'Initials': 'NA', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Corporation Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Fernando Guillermo', 'Initials': 'FG', 'LastName': 'Costa', 'Affiliation': 'Asofarma S.A.I y C. (Asofarma Sociedad Anónima Industrial y Comercial), Buenos Aires, Argentina.'}, {'ForeName': 'Cheung-Tak', 'Initials': 'CT', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Corporation Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Mónica Esther', 'Initials': 'ME', 'LastName': 'Rosenberg', 'Affiliation': 'Asofarma S.A.I y C. (Asofarma Sociedad Anónima Industrial y Comercial), Buenos Aires, Argentina.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.813']
1948,32468741,Pharmacokinetics and Safety of Two Voriconazole Formulations after Intravenous Infusion in Healthy Korean Volunteers.,"BACKGROUND


Voriconazole, a triazole antifungal agent exhibits broad-spectrum antifungal activity. It is used to treat severe, invasive fungal infections, including invasive aspergillosis and candidemia. The aim of this study was to assess the pharmacokinetic equivalence of a test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole.
MATERIALS AND METHODS


This was a randomized, open-label, single-dose, three-group, two-treatment, two-sequence, two-period, crossover phase I trial with 7-day washout periods (ClinicalTrials.gov identifier NCT02631954). Twenty-four healthy Korean male subjects were recruited. In each group, eight subjects were randomized in a 1:1 manner to receive a single dose of 200 mg test or reference formulation intravenously over 1.5 h. Blood samples were collected over 24 h post-dose, and plasma drug concentrations were determined by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were determined using a non-compartmental analysis, and safety was evaluated.
RESULTS


Twenty-three subjects completed the study. The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570 (0.8178 - 1.1199) for the maximum plasma concentration (C max ) and 1.0720 (1.0262 - 1.1198) for the area under the concentration-time curve from dosing to the last quantifiable concentration (AUC last ). The mean plasma concentration-time profiles, pharmacokinetic parameters, and safety were comparable between the two formulations.
CONCLUSION


Equivalent pharmacokinetic characteristics that satisfied the criteria of bioequivalence and similar safety profiles were observed for both test and reference formulations of voriconazole.",2020,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"['Twenty-three subjects completed the study', 'Twenty-four healthy Korean male subjects were recruited', 'Healthy Korean Volunteers']","['Two Voriconazole Formulations', 'test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole']","['geometric mean ratio', 'maximum plasma concentration (C max ', 'mean plasma concentration-time profiles, pharmacokinetic parameters, and safety', 'pharmacokinetic equivalence']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1136812', 'cui_str': 'Vfend'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",8.0,0.088423,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"[{'ForeName': 'Sang Heon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea. shcho123@inha.ac.kr.'}, {'ForeName': 'Cheol Woo', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}, {'ForeName': 'Moon Suk', 'Initials': 'MS', 'LastName': 'Nam', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}]",Infection & chemotherapy,['10.3947/ic.2020.52.2.204']
1949,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION


As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
1950,32472801,Prophylactic Intrathecal Morphine and Prevention of Post-Dural Puncture Headache: A Randomized Double-blind Trial: Erratum.,,2020,,['Post-Dural Puncture Headache'],['Prophylactic Intrathecal Morphine'],[],"[{'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.674421,,[],Anesthesiology,['10.1097/ALN.0000000000003411']
1951,32472804,Goal-directed versus Standard Fluid Therapy to Decrease Ileus after Open Radical Cystectomy: A Prospective Randomized Controlled Trial.,"BACKGROUND


Postoperative ileus is a common complication of intraabdominal surgeries, including radical cystectomy with reported rates as high as 32%. Perioperative fluid administration has been associated with improvement in postoperative ileus rates, but it is difficult to generalize because earlier studies lacked standardized definitions of postoperative ileus and other relevant outcomes. The hypothesis was that targeted individualized perioperative fluid management would improve postoperative ileus in patients receiving radical cystectomy.
METHODS


This is a parallel-arm, double-blinded, single-center randomized trial of goal-directed fluid therapy versus standard fluid therapy for patients undergoing open radical cystectomy. The primary outcome was postoperative ileus, and the secondary outcome was complications within 30 days post-surgery. Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation. The intervention in the goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring.
RESULTS


Between August 2014 and April 2018, 283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy) were included in the analysis. Postoperative ileus occurred in 25% (36 of 142) of patients in the goal-directed fluid therapy arm and 21% (30 of 141) of patients in the standard arm (difference in proportions, 4.1%; 95% CI, -5.8 to 13.9; P = 0.418). There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
CONCLUSIONS


Goal-directed fluid therapy may not be an effective strategy for lowering the risk of postoperative ileus in patients undergoing open radical cystectomy.",2020,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","['patients undergoing open radical cystectomy', '283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy', 'patients having radical cystectomy', 'patients receiving radical cystectomy', 'Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation', 'Between August 2014 and April 2018']","['fluid therapy versus standard fluid therapy', 'intraoperative fluid therapy over standard fluid therapy', 'Standard Fluid Therapy', 'Open Radical Cystectomy', 'goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring']","['incidence of high-grade complications', 'postoperative ileus', 'Postoperative ileus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}]",,0.569234,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","[{'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Anesthesiology Service (V.A.-C., A.C.P., M.F.) the Department of Epidemiology and Biostatistics (K.S.T.) the Department of Surgery, Urology Service (G.D., H.W.H., B.H.B., E.K.C., T.F.D., S.M.D.), Memorial Sloan Kettering Cancer Center, New York, New York the Departments of Urology (G.D., H.W.H., B.H.B., E.K.C., S.M.D.) Anesthesiology (A.C.P., M.F.), Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Kay See', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': ''}, {'ForeName': 'Alessia C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': ''}, {'ForeName': 'Harry W', 'Initials': 'HW', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Bernard H', 'Initials': 'BH', 'LastName': 'Bochner', 'Affiliation': ''}, {'ForeName': 'Eugene K', 'Initials': 'EK', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Donahue', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'S Machele', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003367']
1952,32470389,Intensity of Renal Replacement Therapy and Duration of Mechanical Ventilation: Secondary Analysis of the Acute Renal Failure Trial Network Study.,"BACKGROUND


Randomized clinical trials have failed to show benefit from increasing intensity of renal replacement therapy (RRT) but continue to be frequently used. In addition, intensive RRT is associated with an increase in adverse events potentially secondary to small solute losses, such as phosphate. We hypothesized that, compared with less-intensive RRT, intensive RRT would lead to longer duration of mechanical ventilation.
RESEARCH QUESTION


Does more-intensive renal replacement therapy in critically ill patients with acute kidney injury increase time to extubation from mechanical ventilation when compared with less-intensive therapy?
STUDY DESIGN AND METHODS


The Acute Renal Failure Trial Network study was a randomized multicenter trial of more-intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 mL/kg per hour) vs less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration at 20 mL/kg per hour) RRT in critically ill patients with acute kidney injury. Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation were included in this Cox-proportional hazards analysis. The primary outcome was the time to first successful extubation off mechanical ventilation.
RESULTS


Patients who were assigned randomly to more-intensive RRT had a 33.3% lower hazard rate of successful extubation (hazard ratio, 0.67; 95% CI, 0.52-0.88; P < .001) when compared with patients who were assigned randomly to less-intensive RRT. Patients who were assigned randomly to more-intensive RRT had, on average, 2.07 ventilator-free days, compared with 3.08 days in those who were assigned randomly to less-intensive RRT (P < .001) over 14 days from start of the study.
INTERPRETATION


Critically ill mechanically ventilated patients who were assigned randomly to more-intensive RRT had longer duration of mechanical ventilation compared with those who were assigned randomly to less-intensive RRT. The reasons for this, such as excessive phosphate loss from more-intensive RRT, deserve further study to optimize the safety and effectiveness of CRRT delivery. This was a post hoc analysis of the Acute Renal Failure Trial Network study; clinical trial registration of the original trial is NCT00076219.",2020,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","['Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation', 'critically ill patients', 'critically ill patients with AKI']","['renal replacement therapy (RRT', 'intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 ml/kg per hour) versus less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration', 'intensive RRT', 'RRT', 'Renal Replacement Therapy and Duration of Mechanical Ventilation']","['time to first successful extubation off mechanical ventilation', 'hazard rate of successful extubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0472688', 'cui_str': 'Continuous venovenous hemodiafiltration'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",1124.0,0.192189,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","[{'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: ssharma@bwh.harvard.edu.""}, {'ForeName': 'Yvelynne P', 'Initials': 'YP', 'LastName': 'Kelly', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Renal Section, Veterans Affairs Pittsburgh Healthcare System, and the Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Sushrut S', 'Initials': 'SS', 'LastName': 'Waikar', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]",Chest,['10.1016/j.chest.2020.05.542']
1953,32470421,"Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study.","BACKGROUND


Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
METHODS


This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
FINDINGS


Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3-4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
INTERPRETATION


This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
FUNDING


Boston Scientific.",2020,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","['313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned', '23 implanting centres in the USA', ""patients with Parkinson's disease"", ""motor symptoms of Parkinson's disease"", '160 patients included in the interim analysis, 121 (76', 'Between May 17, 2013, and Nov 30, 2017', '313 patients were enrolled across 23 sites', ""Parkinson's disease (INTREPID"", ""Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent""]","['subthalamic nucleus DBS with a novel MICC device', 'Subthalamic nucleus deep brain stimulation', 'Deep brain stimulation (DBS', 'active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group', 'novel multiple independent contact current-controlled (MICC) device']","['ON time without troublesome dyskinesias', 'anti-parkinsonian medications', 'mean number of waking hours per day with good symptom control and no troublesome dyskinesias', '26 serious adverse events', 'mean change from baseline visit to 3 months post-randomisation']","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",313.0,0.575314,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","[{'ForeName': 'Jerrold L', 'Initials': 'JL', 'LastName': 'Vitek', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA. Electronic address: vitek004@umn.edu.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Tröster', 'Affiliation': 'Department of Clinical Neuropsychology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schrock', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'House', 'Affiliation': 'Neurosurgical Associates, Murray, UT, USA.'}, {'ForeName': 'Monique L', 'Initials': 'ML', 'LastName': 'Giroux', 'Affiliation': 'Movement and Neuroperformance Center of Colorado, Englewood, CO, USA; Clinical Research Neurology, Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Hebb', 'Affiliation': 'Department of Neurological Surgery, Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sierra M', 'Initials': 'SM', 'LastName': 'Farris', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA; Movement and Neuroperformance Center of Colorado, Englewood, CO, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Whiting', 'Affiliation': 'Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Leichliter', 'Affiliation': 'Department of Neurology, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Ostrem', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Luciano', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Verhagen Metman', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Sani', 'Affiliation': 'Department of Neurological Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mustafa S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Tatter', 'Affiliation': 'Department of Neurosurgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Ihtsham', 'Initials': 'I', 'LastName': 'Ul Haq', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Andre G', 'Initials': 'AG', 'LastName': 'Machado', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Gostkowski', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tagliati', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Adam N', 'Initials': 'AN', 'LastName': 'Mamelak', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'Department of Neurology, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Foote', 'Affiliation': 'Department of Neurosurgery, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Moguel-Cobos', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Ponce', 'Affiliation': 'Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jules M', 'Initials': 'JM', 'LastName': 'Nazzaro', 'Affiliation': 'Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cathrin M', 'Initials': 'CM', 'LastName': 'Buetefisch', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gross', 'Affiliation': 'Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Corneliu C', 'Initials': 'CC', 'LastName': 'Luca', 'Affiliation': 'Department of Neurology, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Jagid', 'Affiliation': 'Department of Neurosurgery, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gonzalo J', 'Initials': 'GJ', 'LastName': 'Revuelta', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Takacs', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Pourfar', 'Affiliation': 'Department of Neurology, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Alon Y', 'Initials': 'AY', 'LastName': 'Mogilner', 'Affiliation': 'Department of Neurosurgery, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'Mandybur', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Rosenow', 'Affiliation': 'Department of Neurosurgery, Northwestern University School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Cooper', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Suketu M', 'Initials': 'SM', 'LastName': 'Khandhar', 'Affiliation': 'Department of Neurology, Kaiser Permanente Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sedrak', 'Affiliation': 'Department of Neurosurgery, Kaiser Permanente Medical Center, Redwood City, CA, USA.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Julie G', 'Initials': 'JG', 'LastName': 'Pilitsis', 'Affiliation': 'Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Uitti', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Starr', 'Affiliation': 'Department of Neurosurgery, University of California, San Francisco, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30108-3']
1954,32473275,Exploring the Effects of an Acute Dose of Antipsychotic Medication on Motivation-mediated BOLD Activity Using fMRI and a Perceptual Decision-making Task.,"The left inferior frontal gyrus and the bilateral ventral striatum are thought to be involved in motivation-mediated decision-making. Antipsychotics may influence this relationship, and atypical antipsychotics improve secondary negative symptoms in schizophrenia, such as loss of motivation, although the acute effects of pharmacological medication on motivation are not fully understood. In this single-blinded, randomized controlled trial, 49 healthy volunteers were randomized into three groups to receive a single dose of haloperidol, aripiprazole or placebo. Between 4.0 and 5.6 h later, participant's brain blood-oxygen-level dependent (BOLD) activity was recorded using functional magnetic resonance imaging (fMRI) while completing a perceptual decision-making fMRI task consisting of one neutral and one motivated condition. Response bias, reflecting the participant's willingness to say that the target stimulus is present, was calculated using signal detection theory. Concurrent with widespread changes in BOLD signal in the motivated vs. neutral condition, a less conservative, mathematically optimal response bias was observed in the motivated condition across the whole sample. Within-group differences in BOLD signal in the left inferior frontal gyrus and bilateral ventral striatum were observed between conditions in the aripiprazole and haloperidol groups, but not in the placebo group. No robust between-group differences in brain activity in the left inferior frontal gyrus or the bilateral ventral striatum were found. Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior. An interesting pattern of correlations possibly related to pharmacologically induced alterations in the dopamine system was observed, although findings remain inconclusive and must be replicated in larger samples.",2020,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.",['49 healthy volunteers'],"['haloperidol, aripiprazole or placebo', 'haloperidol', 'Antipsychotics', 'aripiprazole', 'antipsychotic medication', 'placebo']","['BOLD signal', 'brain blood-oxygen-level dependent (BOLD) activity', 'brain activity', 'bilateral ventral striatum']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",49.0,0.0560753,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Delfin', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Ethics, Law and Mental Health, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Sweden; Research Department, Regional Forensic Psychiatric Clinic Växjö, Sweden. Electronic address: carl.delfin@gu.se.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Reckless', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Bolstad', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Computational Radiology & Artificial Intelligence, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}]",Neuroscience,['10.1016/j.neuroscience.2020.05.035']
1955,32473355,TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.,"Chronic kidney disease (CKD) is associated with an increased risk of acute coronary syndrome (ACS) and cardiovascular death. CKD patients suffering from ACS are exposed to an increased risk of thrombotic recurrences and a higher bleeding rate than patients with normal renal function. However, CKD patients are excluded or underrepresented in clinical trials. Therefore, determining the optimal antiplatelet strategy in this population is of utmost importance. We designed the TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome (TROUPER) trial: a prospective, controlled, multicenter, randomized trial to investigate the optimal P2Y12 antagonist in CKD patients with ACS. Patients with stage ≥3b CKD are eligible if the diagnosis of ACS is made and invasive strategy scheduled. Patients are randomized 1:1 between a control group with a 600-mg loading dose of clopidogrel followed by a 75-mg/d maintenance dose for 1 year and an experimental group with a 180-mg loading dose of ticagrelor followed by a 90-mg twice daily maintenance dose for the same duration. The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year. Safety will be evaluated by the bleeding rate (Bleeding Academic Research Consortium). To demonstrate the superiority of ticagrelor on major adverse cardiovascular events, we calculated that 508 patients are required. The aim of the TROUPER trial is to compare the efficacy of ticagrelor and clopidogrel in stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy. RCT# NCT03357874.",2020,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","['508 patients are required', 'CKD patients with ACS', 'CKD patients suffering from ACS', 'Patients with stage ≥3b', 'severe or terminal chronic kidney patients Undergoing', 'Chronic kidney disease (CKD', 'severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome', 'stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy']","['ticagrelor and clopidogrel', 'PERcutaneous coronary intervention', 'clopidogrel', 'TicagRelor Or Clopidogrel', 'ticagrelor']","['risk of thrombotic recurrences', 'rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year', 'bleeding rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0495371,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. Electronic address: marc.laine@ap-hm.fr.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lemesle', 'Affiliation': ""Institut Cœur et Poumon, CHRU de Lille, Faculté de Médecine de l'Université de Lille, Unité INSERM UMR 1011, Lille, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Burtey', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France; Service de Néphrologie, Hôpital de la Conception, Assistance Publique des Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Département de Cardiologie, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'Département de Cardiologie, CHU Chartres, Chartres, France.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Quaino', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Toulon, Toulon, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Canault', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pankert', 'Affiliation': ""Service de Cardiologie, Centre Hospitalier d'Avignon, Avignon, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Paganelli', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Département de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Université Paris Descartes, INSERM U-970, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}]",American heart journal,['10.1016/j.ahj.2020.04.013']
1956,32485328,Randomized trial of argatroban plus recombinant tissue-type plasminogen activator for acute ischemic stroke (ARAIS): Rationale and design.,"BACKGROUND


Previous studies have implied the efficacy and safety of argatroban plus recombinant tissue-type plasminogen activator (r-tPA) in patients with acute ischemic stroke. Further trials are needed to establish convincing conclusions in a large sample size.
RESEARCH DESIGN AND METHODS


Argatroban plus r-tPA for Acute Ischemic Stroke (ARAIS) trial is a multicenter, prospective, randomized, open-label, and blind-end point trial. The trial proposes to randomize 808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5 hours of symptom onset to receive argatroban (100 μg/kg bolus followed by an infusion of 1.0 μg/kg per minute for 48 hours) plus r-tPA or r-tPA alone. The primary end point is the proportion of patients with an excellent outcome of no clinically significant residual stroke deficits (modified Rankin scale 0-1) at 90 days. Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days. Safety end points include symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding.
CONCLUSION


ARAIS trial will evaluate whether argatroban plus r-tPA is superior to r-tPA alone in improving functional outcomes in acute ischemic stroke patients in a large sample population.",2020,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","['acute ischemic stroke (ARAIS', 'acute ischemic stroke patients in a large sample population', '808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5\u202fhours of symptom onset to receive', 'patients with acute ischemic stroke']","['argatroban plus recombinant tissue-type plasminogen activator (r-tPA', 'argatroban plus r-tPA', 'argatroban plus recombinant tissue-type plasminogen activator', 'Argatroban plus r-tPA', 'argatroban (100\u202fμg/kg bolus followed by an infusion of 1.0\u202fμg/kg per minute for 48\u202fhours) plus r-tPA or r-tPA alone']","['stroke recurrence or other vascular events', 'symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding', 'NIHSS score', 'proportion of patients with a good outcome (modified Rankin scale 0-2) at 90\u202fdays, early neurological improvement (NIHSS score\u202f≥2-point decrease) at 48\u202fhours, early neurological deterioration (NIHSS score\u202f≥4-point increase', 'functional outcomes', 'proportion of patients with an excellent outcome of no clinically significant residual stroke deficits']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",808.0,0.128243,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhonghe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China. Electronic address: chszh@aliyun.com.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China. Electronic address: yilong528@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.003']
1957,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND


Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking.
RESEARCH QUESTION


Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters.
METHODS


This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments.
RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain.
SIGNIFICANCE


This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030']
1958,32458557,Partial sleep deprivation after an acute exercise session does not augment hepcidin levels the following day.,"The purpose of the present study was to determine the effects of partial sleep deprivation (PSD) after an exercise session in the evening on the endurance exercise-induced hepcidin response the following morning. Ten recreationally trained males participated under two different conditions. Each condition consisted of 2 consecutive days of training (days 1 and 2). On day 1, participants ran for 60 min at 75% of maximal oxygen uptake (  V   ˙    O 2max  ) followed by 100 drop jumps. Sleep duration at night was manipulated, with a normal length of sleep (CON condition, 23:00-07:00 hr) or a shortened length of sleep (PSD condition). On the morning of day 2, the participants ran for 60 min at 65% of  V   ˙    O 2max  . Sleep duration was significantly shorter under the PSD condition (141.2 ± 13.3 min) than under the CON condition (469.0 ± 2.3 min, p < .0001). Serum hepcidin, plasma interleukin (IL)-6, serum haptoglobin, iron, and myoglobin levels did not differ significantly between the conditions (p > .05) on the morning (before exercise) of day 2. Additionally, the 3-hr postexercise levels for the hematological variables were not significantly different between the two conditions (p > .05). In conclusion, the present study demonstrated that a single night of PSD after an exercise session in the evening did not affect baseline serum hepcidin level the following morning. Moreover, a 60 min run the following morning increased serum hepcidin and plasma IL-6 levels significantly, but the exercise-induced elevations were not affected by PSD.",2020,"Additionally, the 3-hr postexercise levels for the hematological variables were not significantly different between the two conditions (p > .05).",['Ten recreationally trained males participated under two different conditions'],"['maximal oxygen uptake (  V', 'partial sleep deprivation (PSD']","['postexercise levels for the hematological variables', 'Serum hepcidin, plasma interleukin (IL)-6, serum haptoglobin, iron, and myoglobin levels', 'hepcidin levels', 'Sleep duration', 'baseline serum hepcidin level', 'serum hepcidin and plasma IL-6 levels', 'Partial sleep deprivation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0427498', 'cui_str': 'Serum haptoglobin measurement'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",,0.0639753,"Additionally, the 3-hr postexercise levels for the hematological variables were not significantly different between the two conditions (p > .05).","[{'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Aoi', 'Initials': 'A', 'LastName': 'Mamiya', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Tatsuhiro', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Badenhorst', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Auckland, New Zealand.'}]",Physiological reports,['10.14814/phy2.14450']
1959,32462307,Comorbid anxiety and irritability symptoms and their association with cognitive functioning in children with ADHD.,"Anxiety and irritability symptoms frequently co-occur in children with Attention-Deficit/Hyperactivity Disorder (ADHD). This study aims to investigate whether irritability and anxiety are uniquely associated with performance on measures of cognitive functioning in children with ADHD and whether these associations hold when accounting for confounding variables. Baseline data was used from a randomised controlled trial of cognitive behavioural therapy for anxiety in children with ADHD (N = 219, 8-13 years). Anxiety was assessed using the child- and parent-reported Spence Children's Anxiety Scale, while irritability was assessed using the parent-reported Affective Reactivity Index. Children completed the National Institutes of Health Toolbox - Cognition Battery. Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03). These associations did not survive correction for multiple comparisons. There was little evidence of an association between anxiety or irritability symptoms and cognitive functioning. Frequent co-occurrence of anxiety and irritability suggests clinicians working with children with ADHD should assess co-morbid symptom profiles to inform the provision of optimum care.",2020,"Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03).","['children with ADHD', 'children with Attention-Deficit/Hyperactivity Disorder (ADHD']",['cognitive behavioural therapy'],"['Anxiety and irritability symptoms', 'Comorbid anxiety and irritability symptoms', ""Spence Children's Anxiety Scale, while irritability"", 'Anxiety', 'anxiety or irritability symptoms and cognitive functioning', 'irritability and anxiety', 'List Sort Working Memory Test', 'Higher symptoms of anxiety', 'symptoms of irritability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0542262,"Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia. nicolacread@gmail.com.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00658-z']
1960,32459651,A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial.,"BACKGROUND


Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited.
OBJECTIVE


This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes.
METHODS


We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A 1c  (HbA 1c ) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA 1c  level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels.
RESULTS


We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI -0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI -1.29 to 1.44) or for physical activity levels at 6 months (mean difference -382.90 steps; 95% CI -860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI -380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months.
CONCLUSIONS


This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397.",2020,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"['people with pre-diabetes', 'People at High Risk of Type 2 Diabetes', 'We enrolled 200 participants: 98', 'people at high risk of developing diabetes', 'Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London']","['smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months', 'Wearable Technology Delivering a Web-Based Diabetes Prevention Program', 'web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP']","['weight', 'PA levels', 'change in HbA1c, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels', 'full-scale RCT, namely, change in weight and physical activity (PA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4076391', 'cui_str': 'Motivational interviewing technique'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",200.0,0.204808,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Staite', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al-Ozairi', 'Affiliation': 'Faculty of Medicine, Department of Medicine & Dasman Diabetes Institute, Kuwait University, Al Kuwayt, Kuwait.'}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hopkins', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""South Thames Cleft Service, St Thomas' Hospital, London, United Kingdom.""}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Basudev', 'Affiliation': 'Health Innovation Network, London, United Kingdom.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mohamedali', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}]",JMIR mHealth and uHealth,['10.2196/15448']
1961,32468672,Rationale and study design of OUTSTEP-HF: a randomised controlled study to assess the effect of sacubitril/valsartan and enalapril on physical activity measured by accelerometry in patients with heart failure with reduced ejection fraction.,"AIM


In PARADIGM-HF, sacubitril/valsartan demonstrated superiority to enalapril in reducing mortality and morbidity in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Several patient-centred outcomes like improved physical activity and quality of life have been emphasised as important treatment goals in HF management. OUTSTEP-HF has been designed to evaluate the effect of sacubitril/valsartan compared with enalapril on non-sedentary daytime physical activity in patients with HFrEF.
METHODS


OUTSTEP-HF is a randomised, actively controlled, double-blind, double-dummy study that plans to enrol 600 ambulatory patients with symptomatic HFrEF in 19 European countries. Patients will be randomised 1:1 to receive sacubitril/valsartan 97/103 mg bid or enalapril 10 mg bid. The primary objective of the study is to assess changes from baseline (Week 0) to Week 12 in exercise capacity measured by the 6-min walk test and in daily non-sedentary daytime activity. Physical activity and objective sleep parameters will be measured by accelerometry using a wrist-worn device, worn continuously from screening (Week -2) until the end of study (Week 12). As a co-primary outcome, changes from baseline in sub-maximal exercise capacity will be assessed by the 6-min walk test. Patient- and physician-reported questionnaires will be used to assess quality of life, changes in signs and symptoms of HF and sleep parameters.
CONCLUSION


OUTSTEP-HF will be the largest randomised trial in HF to date to use non-invasive accelerometry to assess whether treatment with sacubitril/valsartan improves patients' daily physical activity and exercise capacity compared with enalapril.",2020,Several patient-centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management.,"['Patients with Heart Failure with Reduced Ejection Fraction', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF', '600 ambulatory patients with symptomatic HFrEF in 19 European countries']","['Sacubitril/Valsartan and Enalapril', 'sacubitril/valsartan 97/103 mg twice-daily (bid) or enalapril 10 mg bid', 'enalapril', 'sacubitril/valsartan', 'OUTSTEP-HF']","['mortality and morbidity', 'Physical Activity', '6-minute walking test', 'physical activity and quality of life (QoL', ""patients' daily physical activity and exercise capacity"", 'sub-maximal exercise capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0454713', 'cui_str': 'European country'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",600.0,0.170912,Several patient-centred outcomes like improved physical activity and quality of life (QoL) have been emphasised as important therapy goals in HF management.,"[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Charité\xa0-\xa0Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht UNiversity, Utrecht, The Netherlands.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': 'Community Heart Failure Program, Department of Cardiology, Bellvitge University Hospital and Biomedical Research Institute (IDIBELL), University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schorr', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ecochard', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rizwan I', 'Initials': 'RI', 'LastName': 'Hussain', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Massimo F', 'Initials': 'MF', 'LastName': 'Piepoli', 'Affiliation': 'Heart Failure Unit, Cardiology Department, G. da Saliceto Hospital, Piacenza, Italy.'}]",European journal of heart failure,['10.1002/ejhf.1919']
1962,32464140,Micro-computed Tomographic Evaluation of the Shaping Ability of 3 Reciprocating Single-File Nickel-Titanium Systems on Single- and Double-Curved Root Canals.,"INTRODUCTION


We performed a micro-computed tomographic assessment of the preparation of moderately single- and double-curved root canals using 3 single-file reciprocating nickel-titanium systems: S1 Plus Standard (Sendoline, Täby, Sweden), WaveOne Gold Primary (Dentsply Sirona, Ballaigues, Switzerland), and Reciproc R25 (VDW, Munich, Germany).
METHODS


Seventy-five moderately curved mandibular molars with 2 separate mesial root canals were assigned to 3 experimental groups (n = 25) (ie, S1 Plus Standard, WaveOne Gold Primary, and Reciproc 25 groups) by forming matched triples according to curvature (15°-40°), radius (≤18 mm), and type of curvature (single or double curved). Teeth were scanned before and after root canal preparation with a resolution of 10.5 μm using micro-computed tomographic imaging (Bruker SkyScan 1272; Bruker microCT, Kontich, Belgium). The following parameters were assessed: changes in root canal volume and surface area, percentage of unshaped canal walls, structure model index, canal transportation, and centering ratio. Data were analyzed using 2- and 3-way analysis of variance with Tukey and Scheffé post hoc tests (significance level of 5%).
RESULTS


No significant differences among groups were observed concerning all parameters. The type of curvature had no significant effect on all tested parameters. Within all experimental groups, canal transportation increased significantly from the apical to the coronal region, of which the majority was directed toward the furcational area.
CONCLUSIONS


Preparation with the 3 nickel-titanium systems did not result in significantly different dimensional changes, and there was no significant effect of the type of curvature on all tested parameters.",2020,"CONCLUSIONS


Preparation with the three NiTi-systems did not result in significantly different dimensional changes and there was no significant effect of the type of curvature on all tested parameters.",['Seventy-five moderately curved mandibular molars with two separate mesial root canals'],[],"['root canal volume and surface area, percentage of unshaped canal walls, structure model index, canal transportation and centering ratio', 'canal transportation']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0447375', 'cui_str': 'Mesial tooth root'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]",[],"[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0565073,"CONCLUSIONS


Preparation with the three NiTi-systems did not result in significantly different dimensional changes and there was no significant effect of the type of curvature on all tested parameters.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Haupt', 'Affiliation': 'Department for Preventive Dentistry, Periodontology and Cariology, University Medical Center, Göttingen, Germany. Electronic address: franziska.haupt@med.uni-goettingen.de.'}, {'ForeName': 'Jonas Robert Wilhelm', 'Initials': 'JRW', 'LastName': 'Pult', 'Affiliation': 'Department for Preventive Dentistry, Periodontology and Cariology, University Medical Center, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hülsmann', 'Affiliation': 'Department for Preventive Dentistry, Periodontology and Cariology, University Medical Center, Göttingen, Germany.'}]",Journal of endodontics,['10.1016/j.joen.2020.05.005']
1963,32464260,"Methylphenidate as Needed for Fatigue in Patients With Advanced Cancer. A Prospective, Double-Blind, and Placebo-Controlled Study.","CONTEXT


Cancer-related fatigue is a highly prevalent symptom with a strong negative impact on patients' daily life.
OBJECTIVES


To evaluate the efficacy of methylphenidate as needed for the management of fatigue in patients with advanced cancer.
METHODS


A prospective, controlled, double-blind, and paired design, where the patient was her and/or his own control. Patients with advanced cancer with a tiredness score of ≥50 on a 0-100 visual analogue scale (VAS) were included. Patients were given 10 placebo and 10 methylphenidate tablets numbered 1-20 packed in blocks of four with two active and two placebo tablets (randomly arranged). Patients taking minimum three tablets were regarded evaluable. Primary effect parameters were mean differences in VAS for tiredness after two and five hours. With 28 evaluable patients, the study had a power of 0.90 to detect a mean difference of 15 between active and placebo.
RESULTS


Thirty-eight patients were enrolled to get 28 evaluable patients. Mean tiredness score before taking the tablets was 75 for placebo and 72 for methylphenidate on VAS (0-100). Mean changes (decrease) for methylphenidate after two and five hours were 20 and 17, respectively, and eight and five for placebo. Comparing mean differences, a significant decrease for methylphenidate compared with placebo was observed after two hours (P = 0.004) and five hours (P = 0.001), respectively.
CONCLUSION


In this controlled and double-blind study in patients with advanced cancer, methylphenidate as needed was significantly more effective than placebo in relieving fatigue after two and five hours.",2020,"Comparing mean differences, a significant decrease for methylphenidate compared to placebo was observed after two hours (p=0.004) and five hours (p=0.001), respectively.
","['Thirty-eight patients were enrolled to get 28 evaluable patients', 'Patients with advanced cancer with a tiredness score > 50 on a 0-100 visual analogue scale (VAS) were included', 'patients with advanced cancer']","['methylphenidate tablets', 'methylphenidate', 'Methylphenidate', 'placebo tablets', 'placebo']","['Mean tiredness score', 'relieving fatigue', 'VAS for tiredness']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",38.0,0.380608,"Comparing mean differences, a significant decrease for methylphenidate compared to placebo was observed after two hours (p=0.004) and five hours (p=0.001), respectively.
","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Pedersen', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark. Electronic address: line.lund.01@regionh.dk.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjogren', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Section of Palliative Medicine, Department of Oncology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Section of Health Services Research, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.05.023']
1964,32471908,Effects of Sustained Treatment With Lixisenatide on Gastric Emptying and Postprandial Glucose Metabolism in Type 2 Diabetes: A Randomized Controlled Trial.,"OBJECTIVE


Tachyphylaxis for slowing of gastric emptying is seen with continuous exposure to glucagon-like peptide 1 (GLP-1). We therefore aimed to establish whether prolonged use of a ""short-acting"" GLP-1 receptor agonist, lixisenatide, achieves sustained slowing of gastric emptying and reduction in postprandial glycemia.
RESEARCH DESIGN AND METHODS


A total of 30 patients with metformin-treated type 2 diabetes underwent assessment of gastric emptying (scintigraphy) and glucose metabolism (dual tracer technique) after a 75-g glucose drink, before and after 8 weeks' treatment with lixisenatide (20 μg subcutaneously daily) or placebo, in a double-blind randomized parallel design.
RESULTS


Gastric retention of the glucose drink was markedly increased after lixisenatide versus placebo (ratio of adjusted geometric means for area under the curve [AUC] over 240 min of 2.19 [95% CI 1.82, 2.64],  P  < 0.001), associated with substantial reductions in the rate of systemic appearance of oral glucose ( P  < 0.001) and incremental AUC for blood glucose ( P  < 0.001). Lixisenatide suppressed both glucagon ( P  = 0.003) and insulin ( P  = 0.032), but not endogenous glucose production, over 120 min after oral glucose intake. Postprandial glucose lowering over 240 min was strongly related to the magnitude of slowing of gastric emptying by lixisenatide ( r  = -0.74,  P  = 0.002) and to the baseline rate of emptying ( r  = 0.52,  P  = 0.048) but unrelated to β-cell function (assessed by β-cell glucose sensitivity).
CONCLUSIONS


Eight weeks' treatment with lixisenatide is associated with sustained slowing of gastric emptying and marked reductions in postprandial glycemia and appearance of ingested glucose. Short-acting GLP-1 receptor agonists therefore potentially represent an effective long-term therapy for specifically targeting postprandial glucose excursions.",2020,"Lixisenatide suppressed both glucagon ( P  = 0.003) and insulin ( P  = 0.032), but not endogenous glucose production, over 120 min after oral glucose intake.","['Type 2 Diabetes', '30 patients with']","['lixisenatide', 'Lixisenatide', 'metformin-treated type 2 diabetes underwent assessment of gastric emptying (scintigraphy) and glucose metabolism (dual tracer technique', 'placebo']","['Gastric Emptying and Postprandial Glucose Metabolism', 'Postprandial glucose lowering', 'rate of systemic appearance of oral glucose', 'Gastric retention of the glucose drink', 'incremental AUC for blood glucose', 'baseline rate of emptying', 'gastric emptying', 'postprandial glycemia and appearance of ingested glucose']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585136', 'cui_str': 'Gastric retention'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.156761,"Lixisenatide suppressed both glucagon ( P  = 0.003) and insulin ( P  = 0.032), but not endogenous glucose production, over 120 min after oral glucose intake.","[{'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia chris.rayner@adelaide.edu.au.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Watson', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Liza K', 'Initials': 'LK', 'LastName': 'Phillips', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Bound', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Grivell', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Centre of Research Excellence for Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ele', 'Initials': 'E', 'LastName': 'Ferrannini', 'Affiliation': 'CNR Institute of Clinical Physiology, Pisa, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Tricò', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Frascerra', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'CNR Institute of Neuroscience, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natali', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}]",Diabetes care,['10.2337/dc20-0190']
1965,32471910,Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial.,"OBJECTIVE


Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system.
RESEARCH DESIGN AND METHODS


After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA 1c , 7.1% [54 mmol/mol]) were randomly assigned to CLC ( N  = 54, Control-IQ) or PLGS ( N  = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study.
RESULTS


All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%;  P  < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI -8.4%, -3.7%;  P  < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI -0.05%, 0.13%;  P  = 0.41). HbA 1c  after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol]; 95% CI -0.57% [-6.2 mmol/mol], -0.11% [1.2 mmol/mol];  P  = 0.0035).
CONCLUSIONS


Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA 1c  toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.",2020,HbA 1c  after 13 weeks was lower on CLC than PLGS (,"['Type 1 Diabetes', 'All 109 participants completed the study', '109 participants with type 1 diabetes (age range, 14-72 years; mean HbA 1c , 7.1% [54 mmol/mol']","['CLC', 'CLC Versus PLGS', 'closed-loop control (CLC) system', 'CLC system', 'PLGS']","['continuous glucose monitor (CGM)-measured time in range (TIR', 'Mean ± SD TIR', 'TIR and increased HbA 1c  toward their pre-CLC values, while hypoglycemia']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",109.0,0.176696,HbA 1c  after 13 weeks was lower on CLC than PLGS (,"[{'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'Division of Endocrinology and Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora, CO.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Levy', 'Affiliation': 'Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ambler-Osborn', 'Affiliation': 'Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'Division of Endocrinology and Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora, CO.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Levister', 'Affiliation': 'Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Vinaya', 'Initials': 'V', 'LastName': 'Simha', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'Division of Endocrinology and Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lum', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL jl_manuscripts@jaeb.org.'}, {'ForeName': 'Boris P', 'Initials': 'BP', 'LastName': 'Kovatchev', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0124']
1966,32469839,Video Narratives Intervention Among Stroke Survivors: Feasibility and Acceptability Study of a Randomized Controlled Trial.,"BACKGROUND


A large number of stroke survivors worldwide suffer from moderate to severe disability. In Malaysia, long-term uncontrolled stroke risk factors lead to unforeseen rates of recurrent stroke and a growing incidence of stroke occurrence across ages, predominantly among the elderly population. This situation has motivated research efforts focused on tapping into patient education, especially related to patient self-efficacy of understanding and taking medication appropriately. Video narratives integrated with health belief model constructs have demonstrated potential impacts as an aide to patient education efforts.
OBJECTIVE


The aim of this study was to investigate the feasibility and acceptability of study procedures based on a randomized controlled trial protocol of a video narratives intervention among poststroke patients. We also aimed to obtain preliminary findings of video narratives related to medication understanding and use self-efficacy (MUSE) and blood pressure control.
METHODS


A parallel group randomized controlled trial including a control group (without video viewing) and an intervention group (with video viewing) was conducted by researchers at a neurology outpatient clinic on poststroke patients (N=54). Baseline data included patients' sociodemographic characteristics, medical information, and all outcome measures. Measurements of MUSE and blood pressure following the trial were taken during a 3-month follow-up period. Feasibility of the trial was assessed based on recruitment and study completion rates along with patients' feedback on the burden of the study procedures and outcome measures. Acceptability of the trial was analyzed qualitatively. Statistical analysis was applied to ascertain the preliminary results of video narratives.
RESULTS


The recruitment rate was 60 out of 117 patients (51.3%). Nevertheless, the dropout rate of 10% was within the acceptable range. Patients were aged between 21 and 74 years. Nearly 50 of the patients (>85%) had adequate health literacy and exposure to stroke education. Most of the patients (>80%) were diagnosed with ischemic stroke, whereby the majority had primary hypertension. The technicalities of randomization and patient approach were carried out with minimal challenge and adequate patient satisfaction. The video contents received good responses with respect to comprehension and simplicity. Moreover, an in-depth phone interview with 8 patients indicated that the video narratives were considered to be useful and inspiring. These findings paralleled the preliminary findings of significant improvement within groups in MUSE (P=.001) and systolic blood pressure control (P=.04).
CONCLUSIONS


The queries and feedback from each phase in this study have been acknowledged and will be taken forward in the full trial.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN 12618000174280; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373554.",2020,"These findings also paralleled significant preliminary improvement in MUSE and systolic BP control (P<.05).
","['post-stroke survivors', 'post-stroke patients', 'Patients were aged between 21 and 74 years', 'Most patients (> 80%) were diagnosed with ischemic stroke whereby the majority were primarily hypertensive', 'researchers at the neurology outpatient clinic on post-stroke patients (N=54']","['video narratives intervention', 'control group (without video-viewing) and an intervention group (with video viewing', 'Video narratives integrated with Health Belief Model (HBM']","['dropout rate', 'MUSE and systolic BP control (P<.05', 'recruitment rate', 'adequate health literacy and exposure to stroke education', 'medication understanding and use self-efficacy (MUSE) and blood pressure (BP) control']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C4303794', 'cui_str': 'Education about stroke'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",117.0,0.0700293,"These findings also paralleled significant preliminary improvement in MUSE and systolic BP control (P<.05).
","[{'ForeName': 'Jamuna Rani', 'Initials': 'JR', 'LastName': 'Appalasamy', 'Affiliation': 'School of Pharmacy, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}, {'ForeName': 'Joyce Pauline', 'Initials': 'JP', 'LastName': 'Joseph', 'Affiliation': 'Department of Neurology, Hospital Kuala Lumpur, Ministry of Health, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Seeta Ramaiah', 'Affiliation': 'Medical Department, Subang Jaya Medical Center, Sunway, Malaysia.'}, {'ForeName': 'Anuar Zaini', 'Initials': 'AZ', 'LastName': 'Md Zain', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}, {'ForeName': 'Kia Fatt', 'Initials': 'KF', 'LastName': 'Quek', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}, {'ForeName': 'Kyi Kyi', 'Initials': 'KK', 'LastName': 'Tha', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.'}]",JMIR aging,['10.2196/17182']
1967,32469870,"Effect of a nutrient-rich, food-based supplement given to rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes: A randomized controlled trial.","Obtaining a nutrient-rich diet during pregnancy is a challenge for pregnant women living in low-income countries. This randomized, controlled trial was designed to determine if a freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables given prior to and/or during pregnancy improved birth outcomes in rural Vietnamese women. Primiparous women, 18 to 30 years of age, who participated in the study were assigned to one of three groups: PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care. Supplement intake was observed and quantified. Infant anthropometry was measured at birth and/or within seven days of delivery. The effect of the intervention on maternal and birth outcomes was determined using linear regression modeling. Of the 460 women enrolled in the study, 317 women completed the study. Those not completing the study had either moved from the area, did not conceive within 12 months of study enrollment, or miscarried. The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups. However, it failed to alter infant anthropometric measurements at birth. In the entire cohort, maternal gestational weight gain was greater in women with a low pre-pregnancy BMI (<18.5) and in women with a higher educational attainment. Working as a farmer reduced gestational weight gain but it did not affect birth weight or length. In summary, a nutrient-rich, food-based supplement given to rural Vietnamese women from pre-conception to term or mid-gestation to term did not affect maternal or infant outcomes. The low weight gains, possibly due to demanding farm work done throughout the reproductive cycle, may have obviated any effects of the low energy, nutrient-rich food supplement on birth outcomes. Trial registration : Registered Clinical Trials.gov: NCT01235767.",2020,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","['rural Vietnamese women', 'pregnant women living in low-income countries', 'Primiparous women, 18 to 30 years of age, who participated in the study', 'rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes', '460 women enrolled in the study, 317 women completed the study']","['freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables', 'nutrient-rich, food-based supplement', 'nutrient-rich diet', 'PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care']","['protein, iron, zinc, folate, vitamin A and B12 intakes', 'maternal gestational weight gain', 'low weight gains', 'gestational weight gain', 'maternal and birth outcomes', 'birth weight or length']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0231246', 'cui_str': 'Failure to gain weight'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",317.0,0.162934,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","[{'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Nguyen T', 'Initials': 'NT', 'LastName': 'Diep Anh', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, United States of America.""}]",PloS one,['10.1371/journal.pone.0232197']
1968,32469881,"Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial.","BACKGROUND


Distal radius fractures are common fractures and the cornerstone of treatment remains immobilization of the wrist in a cast. At present, there is a scarcity of studies that compare different cast immobilization methods. The objective of the study was therefore to compare volar-flexion and ulnar deviation cast to functional cast position in the treatment of dorsally displaced distal radius fracture among elderly patients.
METHODS AND FINDINGS


We performed a pragmatic, randomized, controlled trial in three emergency centers in Finland. After closed reduction of the fracture, the wrist was placed in either volar-flexion and ulnar deviation cast or functional cast position. The follow-up was 12 months. The primary outcome was patient-rated wrist evaluation (PRWE) score at 12 months. The secondary outcomes were Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale. The number of complications was also recorded. In total, 105 participants were included in the study. Of these, 88% were female and the mean age was 73.5 (range 65-94) years. In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9 (95% CI: -13.1.- 3.4., p = .24) in favor of the functional cast position. Operative treatment due to loss of reduction of fracture was performed for four patients (8%) in the FC group and for seven patients (13%) in the volar-flexion and ulnar deviation cast group (OR: 0.63, 95% CI: 0.16-2.1).
CONCLUSION


In this study, the data were consistent with a wide range of treatment effects when comparing two different cast positions in the treatment of distal radius fracture among elderly patients at 12-month follow-up. However, the functional cast is more likely to be superior when compared to volar-flexion and ulnar deviation cast.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02894983 Accessible: https://clinicaltrials.gov/ct2/show/NCT02894983.",2020,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","['88% were female and the mean age was 73.5 (range 65-94) years', 'dorsally displaced distal radius fracture among elderly patients', '105 participants were included in the study', ""patients with Colles' fracture"", 'three emergency centers in Finland']",['volar-flexion and ulnar deviation cast to functional cast position'],"['Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale', 'patient-rated wrist evaluation (PRWE) score', 'patient-rated wrist evaluation measure', 'number of complications', 'reduction of fracture', 'distal radius fracture']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009353', 'cui_str': ""Colles' fracture""}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",105.0,0.170183,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","[{'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Raittio', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Antti P', 'Initials': 'AP', 'LastName': 'Launonen', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Hevonkorpi', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Luokkala', 'Affiliation': 'Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kukkonen', 'Affiliation': 'Satakunta Central Hospital, Pori, Finland.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Reito', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Minna K', 'Initials': 'MK', 'LastName': 'Laitinen', 'Affiliation': 'Division of Orthopaedics and Traumatology, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ville M', 'Initials': 'VM', 'LastName': 'Mattila', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}]",PloS one,['10.1371/journal.pone.0232153']
1969,32470486,"Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.","BACKGROUND


Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation.
OBJECTIVE


This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019.
METHODS


We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019.
RESULTS


Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus standard-of-care treatment (22 patients) or placebo based on standard-of-care treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study. Treatment with ruxolitinib plus standard-of-care was not associated with significantly accelerated clinical improvement in severe patients with coronavirus disease 2019, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed computed tomography improvement at day 14 compared with 13 (61.9%) patients from the control group (P = .0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at day 28; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group.
CONCLUSIONS


Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest computed tomography improvement, a faster recovery from lymphopenia, and favorable side-effect profile in the ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.",2020,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","['severe coronavirus disease 2019 (COVID-19', 'patients with severe COVID-19', 'Forty-three patients']","['ruxolitinib plus SoC', 'placebo based on SoC treatment', 'ruxolitinib plus SoC treatment']","['tolerated with low toxicities and no new safety signals', 'overall mortality', 'died of respiratory failure', 'CT improvement', 'Levels of 7 cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",43.0,0.116984,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Tiebin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Gaoxiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fankai', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jungang', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Divisions of Pathology and Experimental Hematology and Cancer Biology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: Gang.Huang@cchmc.org.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: wwang@vip.126.com.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: jfzhou@tjh.tjmu.edu.cn.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.019']
1970,32470515,Ramipril in High-Risk Patients With COVID-19.,"BACKGROUND


Coronavirus disease-2019 (COVID-19) is caused by severe acute respiratory-syndrome coronavirus-2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2. This interaction has been proposed as a potential risk factor in patients treated with RAAS inhibitors.
OBJECTIVES


This study analyzed whether RAAS inhibitors modify the risk for COVID-19.
METHODS


The RASTAVI (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation) trial is an ongoing randomized clinical trial randomly allocating subjects to ramipril or control groups after successful transcatheter aortic valve replacement at 14 centers in Spain. A non-pre-specified interim analysis was performed to evaluate ramipril's impact on COVID-19 risk in this vulnerable population.
RESULTS


As of April 1, 2020, 102 patients (50 in the ramipril group and 52 in the control group) were included in the trial. Mean age was 82.3 ± 6.1 years, 56.9% of the participants were male. Median time of ramipril treatment was 6 months (interquartile range: 2.9 to 11.4 months). Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving ramipril; hazard ratio: 1.150; 95% confidence interval: 0.351 to 3.768). The risk of COVID-19 was increased in older patients (p = 0.019) and those with atrial fibrillation (p = 0.066), lower hematocrit (p = 0.084), and more comorbidities according to Society of Thoracic Surgeons score (p = 0.065). Admission and oxygen supply was required in 4.9% of patients (2 in the ramipril group and 3 in the control group), and 4 of them died (2 in each randomized group). A higher body mass index was the only factor increasing the mortality rate (p = 0.039).
CONCLUSIONS


In a high-risk population of older patients with cardiovascular disease, randomization to ramipril had no impact on the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS inhibitor treatment during the COVID-19 crisis. (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation [RASTAVI]; NCT03201185).",2020,"The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065).","['High Risk Patients with COVID-19', 'patients treated with RAAS-inhibitors', '102 patients (50 Ramipril and 52 controls) were included in the trial', 'Mean age was 82.3±6.1 years, 56.9% males']",['Ramipril'],"['Admission and oxygen supply', 'mortality rate', 'risk of COVID-19', 'atrial fibrillation', 'incidence or severity of COVID-19', 'Median time']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0072973', 'cui_str': 'Ramipril'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.117341,"The risk of COVID-19 was increased in older patients (p=0.019), those with atrial fibrillation (p=0.066), lower hematocrit (p=0.084), and more comorbidities according to Society of thoracic surgeons score (p=0.065).","[{'ForeName': 'Ignacio J', 'Initials': 'IJ', 'LastName': 'Amat-Santos', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain. Electronic address: ijamat@gmail.com.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Santos-Martinez', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'López-Otero', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela-Franco', 'Affiliation': 'Cardiovascular Institute, Hospital Clínico San Carlos, El Instituto de Investigación Sanitaria San Carlos, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gutiérrez-Ibanes', 'Affiliation': 'CIBERCV, Hospital General Gregorio Marañón and Universidad Carlos III, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Del Valle', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Muñoz-García', 'Affiliation': 'CIBERCV, Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Víctor A', 'Initials': 'VA', 'LastName': 'Jiménez-Diaz', 'Affiliation': 'Hospital Universitario de Vigo, Vigo, Spain.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Regueiro', 'Affiliation': 'Hospital Clinic Univeristari, Barcelona, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'González-Ferreiro', 'Affiliation': 'Hospital Clínico Universitario, Salamanca, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Benito', 'Affiliation': 'Hospital Universitario de León, León, Spain.'}, {'ForeName': 'Xoan Carlos', 'Initials': 'XC', 'LastName': 'Sanmartin-Pena', 'Affiliation': 'CIBERCV, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Catalá', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Rodríguez-Gabella', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Jose Raúl', 'Initials': 'JR', 'LastName': 'Delgado-Arana', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Carrasco-Moraleja', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibañez', 'Affiliation': 'CIBERCV, Centro Nacional de Investigaciones Cardiovasculares, IIS-Hospital Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'San Román', 'Affiliation': 'Cardiology Department, Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Hospital Clínico Universitario, Valladolid, Spain.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.040']
1971,32583907,Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation.,"BACKGROUND


Agonists of 5-hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS-C). However, only tegaserod has been approved for a very limited population in the US.
AIM


To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS-C.
METHODS


A double-blind, placebo-controlled, dose-finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The primary endpoint was Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements from baseline and improvement of ≥30% from baseline in weekly average of worst abdominal pain score, both in the same week for ≥6/12 weeks).
RESULTS


The FDA composite responder rate was 13.6% (14/103) in the placebo group, 13.6% (14/103) in the 10 mg group, 19.2% (20/104) in the 20 mg group and 14.9% (15/101) in the 40 mg group, and no dose-response relationship was found. A greater percentage of minesapride 40 mg-treated patients than placebo-treated patients met both responder requirements for ≥9/12 weeks as the stricter composite evaluation (P < 0.05). Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12). The most common adverse event was mild diarrhoea.
CONCLUSIONS


Minesapride was safe and well-tolerated. Although the primary endpoint was negative, minesapride 40 mg is likely to improve the stricter composite endpoint and SBM frequency. Japan Pharmaceutical Information Center Number: Japic CTI-163459.",2020,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","['irritable bowel syndrome with predominant constipation (IBS-C', 'patients with Rome IV defined IBS-C', 'irritable bowel syndrome with predominant constipation', '411 patients']","['5-hydroxytryptamine', 'minesapride vs placebo', 'minesapride', 'placebo']","['stricter composite endpoint and SBM frequency', 'SBM frequency', 'Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements', 'efficacy and safety', 'safe and well-tolerated', 'worst abdominal pain score', 'FDA composite responder rate']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",411.0,0.467554,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","[{'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Inada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kiyoyasu', 'Initials': 'K', 'LastName': 'Kazumori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15907']
1972,32580282,The Effects of a Low Calorie Ketogenic Diet on Glycaemic Control Variables in Hyperinsulinemic Overweight/Obese Females.,"Diet is a factor which can influence both glycaemic variables and body mass. The aim of this study was to compare the influence of a 12-week, well-planned, low-calorie ketogenic diet (LCKD) on hyperglycaemic, hyperinsulinemic and lipid profile in adult, overweight or obese females. Ninety-one females who participated in the study were divided into two groups: a LCKD group who followed a hypocaloric ketogenic diet (8% of carbohydrate, 72% of fat and 20% of proteins) ( n  = 46), and a control group (CG) ( n  = 45) who continued their typical diet (50% of carbohydrates, 32% of fat and 18% of proteins).
METHODS


Baseline and post-intervention glucose (Gl), insulin (I), glycated haemoglobin (HbA1c), Homeostatic model assessment HOMA-IR, triglycerides (TG) and high-density cholesterol (HDL-C) were evaluated. Also, body mass (BM), waist circumference (WC), hip circumference (HC) and thigh circumference (TC) were measured.
RESULTS


Compared with the CG, there were significant changes observed in the LCKD group regarding all biochemical variables. Also, BM, TC, WC and AC changed significantly in the LCKD group compared with the CG.
CONCLUSIONS


The 12-week LCKD intervention changed the glucose control variables, body mass, as well as waist, hip and thigh circumferences. A low-calorie ketogenic diet may be recommended for adult females with glucose control variables disturbance and excess body mass.",2020,"Compared with the CG, there were significant changes observed in the LCKD group regarding all biochemical variables.","['Ninety-one females who participated in the study', 'adult, overweight or obese females', 'Hyperinsulinemic Overweight/Obese Females', 'adult females with glucose control variables disturbance and excess body mass']","['well-planned, low-calorie ketogenic diet (LCKD', 'control group (CG) ( n  = 45) who continued their typical diet', 'LCKD group who followed a hypocaloric ketogenic diet', 'LCKD', 'Low Calorie Ketogenic Diet']","['hyperglycaemic, hyperinsulinemic and lipid profile', 'body mass (BM), waist circumference (WC), hip circumference (HC) and thigh circumference (TC', 'post-intervention glucose (Gl), insulin (I), glycated haemoglobin (HbA1c), Homeostatic model assessment HOMA-IR, triglycerides (TG) and high-density cholesterol (HDL-C', 'BM, TC, WC and AC', 'Glycaemic Control Variables']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",91.0,0.0169054,"Compared with the CG, there were significant changes observed in the LCKD group regarding all biochemical variables.","[{'ForeName': 'Małgorzata Magdalena', 'Initials': 'MM', 'LastName': 'Michalczyk', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, 72a Mikołowska Street, 40-065 Katowice, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Klonek', 'Affiliation': 'Lenacor Diet Clinic, Świętojańska 2a Street, 41-400 Mysłowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Maszczyk', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, 72a Mikołowska Street, 40-065 Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, 72a Mikołowska Street, 40-065 Katowice, Poland.'}]",Nutrients,['10.3390/nu12061854']
1973,32585997,Changes in the Intestinal Microbiome during a Multispecies Probiotic Intervention in Compensated Cirrhosis.,"Probiotics have been used in trials to therapeutically modulate the gut microbiome and have shown beneficial effects in cirrhosis. However, their effect on the microbiome of cirrhosis patients is not fully understood yet. Here, we tested the effects of a multispecies probiotic on microbiome composition in compensated cirrhosis. The gut microbiome composition of 58 patients with compensated cirrhosis from a randomized controlled trial who received a daily dose of multispecies probiotics or placebo for six months was analysed by 16S rRNA gene sequencing. Microbiome composition of patients who received probiotics was enriched with probiotic strains and the abundance of  Faecalibacterium prausnitzii ,  Syntrophococcus sucromutans ,  Bacteroides vulgatus ,  Alistipes shahii  and a  Prevotella  species was increased in the probiotic group compared to the placebo group. Patients who had microbiome changes in response to probiotic treatment also showed a significant increase in neopterin and a significant decrease in faecal zonulin levels after intervention, which was not observed in placebo-treated patients or patients with unchanged microbiome compositions. In conclusion, multispecies probiotics may enrich the microbiome of compensated cirrhotic patients with probiotic bacteria during a six-month intervention and beneficially change the residential microbiome and gut barrier function.",2020,"Microbiome composition of patients who received probiotics was enriched with probiotic strains and the abundance of  Faecalibacterium prausnitzii ,  Syntrophococcus sucromutans ,  Bacteroides vulgatus ,  Alistipes shahii  and a  Prevotella  species was increased in the probiotic group compared to the placebo group.","['58 patients with compensated cirrhosis', 'compensated cirrhosis']","['multispecies probiotics or placebo', 'Multispecies Probiotic Intervention', 'multispecies probiotic', 'placebo']","['microbiome composition', 'neopterin', 'faecal zonulin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",58.0,0.114675,"Microbiome composition of patients who received probiotics was enriched with probiotic strains and the abundance of  Faecalibacterium prausnitzii ,  Syntrophococcus sucromutans ,  Bacteroides vulgatus ,  Alistipes shahii  and a  Prevotella  species was increased in the probiotic group compared to the placebo group.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Durdevic', 'Affiliation': 'Center for Medical Research, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Division of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'di Vora', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rainer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Krones', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Douschan', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Spindelboeck', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Durchschein', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Zollner', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Rudolf E', 'Initials': 'RE', 'LastName': 'Stauber', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fickert', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Stiegler', 'Affiliation': 'Division of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stadlbauer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}]",Nutrients,['10.3390/nu12061874']
1974,32586400,"Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).","BACKGROUND


Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival and the effect of out-of-school-hours teaching on children's literacy and numeracy in rural Madhya Pradesh.
METHODS/DESIGN


This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The clusters are 196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention. The participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation. The participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020.
DISCUSSION


In CHAMPION2, the NICE Foundation will deliver a 3.5-year programme comprising Accredited Social Health Activists or village health workers and midwives promoting health knowledge and providing antenatal, postnatal, and neonatal healthcare; community mobilisation; referrals to appropriate government health facilities; and a health education campaign. In STRIPES2, the Pratham Education Foundation will deliver a programme of village-based, before/after school support focusing on literacy and numeracy. As controls, the CHAMPION2 control villages will receive the usual health services (plus the STRIPES2 intervention). STRIPES2 control villages will receive the usual education services (plus the CHAMPION2 intervention). The primary outcome in CHAMPION2 is neonatal mortality. Secondary outcomes include antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness. The primary outcome in STRIPES2 is a composite literacy and numeracy test score. Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness. Independent research and implementation teams will conduct the trial. Trial Steering and Data Monitoring Committees, with independent members, will supervise the trial.
TRIAL REGISTRATION


Clinical Trial Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.",2020,"Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness.","['participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation', 'participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020', '196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention', ""children's literacy and numeracy in rural Madhya Pradesh""]","['villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention', 'school-hours teaching', 'complex package of health interventions']","[""separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness"", 'composite literacy and numeracy test score', 'neonatal survival', 'antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness', 'neonatal mortality']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",,0.117173,"Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness.","[{'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Rukmini', 'Initials': 'R', 'LastName': 'Banerji', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boone', 'Affiliation': 'Effective Intervention, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ila', 'Initials': 'I', 'LastName': 'Fazzio', 'Affiliation': 'Effective Intervention, London, UK. if@effint.org.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frost', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Gopal', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Karnati', 'Affiliation': 'GH Training and Consulting, Hyderabad, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Harshavardhan', 'Initials': 'H', 'LastName': 'Reddy', 'Affiliation': 'GH Training and Consulting, Hyderabad, India.'}, {'ForeName': 'Padmanabh', 'Initials': 'P', 'LastName': 'Reddy', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Dropti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Sajjan Singh', 'Initials': 'SS', 'LastName': 'Shekhawat', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Siddharudha', 'Initials': 'S', 'LastName': 'Shivalli', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}]",Trials,['10.1186/s13063-020-04339-6']
1975,32588671,Observation on the effects of 595- nm pulsed dye laser and 755- nm long-pulsed alexandrite laser on sequential therapy of infantile hemangioma.,"BACKGROUND


Infantile hemangioma (IH) can lead to severe complications. The 595-nm pulsed dye laser is poorly effective on thick and deep IH. Long-pulsed alexandrite laser has the proper wavelength of 755 nm and a relatively deep penetration. Thus, this may be a safe and effective treatment method for relatively deep or thick IH.
AIMS AND OBJECTIVES


This study aims to determine whether 595-nm pulsed dye laser and 755-nm long-pulsed alexandrite laser in sequential therapy are safer and more effective for relatively deep or thick hemangioma.
MATERIALS AND METHODS


This was a prospective study. A total of 194 infantile IH patients (thickness greater than 2 mm and less than 8 mm) were randomly divided into two groups: control group (treated using 595-nm pulsed dye laser) and experimental group (treated by sequential therapy with 755-nm long-pulsed alexandrite laser and 595-nm dye laser).
RESULTS


The control group had a total effective rate of 36.1%, while the experimental group had a total effective rate of 76.3%. Enumeration data were compared by  X 2  -test. The results were considered statistically significant at  P  < .05.
CONCLUSION


Sequential therapy with 755-nm pulsed dye laser and 595-nm long-pulsed alexandrite laser is a safe and effective treatment approach for relatively deep or thick hemangioma.",2020,"The control group had a total effective rate of 36.1%, while the experimental group had a total effective rate of 76.3%.","['194 infantile IH patients (thickness greater than 2 mm and less than 8 mm', 'infantile hemangioma']","['595- nm pulsed dye laser and 755- nm long-pulsed alexandrite laser', '595-nm pulsed dye laser and 755-nm long-pulsed alexandrite laser', '755-nm pulsed dye laser and 595-nm long-pulsed alexandrite laser', '595-nm pulsed dye laser', 'Long-pulsed alexandrite laser', 'control group (treated using 595-nm pulsed dye laser) and experimental group (treated by sequential therapy with 755-nm long-pulsed alexandrite laser and 595-nm dye laser']",['total effective rate'],"[{'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C5191367', 'cui_str': '595'}, {'cui': 'C0392258', 'cui_str': 'Dye laser device'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0392245', 'cui_str': 'Alexandrite laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1289859', 'cui_str': 'Pulsed dye laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.017411,"The control group had a total effective rate of 36.1%, while the experimental group had a total effective rate of 76.3%.","[{'ForeName': 'Wan-Wan', 'Initials': 'WW', 'LastName': 'Jin', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Wu', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'He-He', 'Initials': 'HH', 'LastName': 'Quan', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}]",Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology,['10.1080/14764172.2020.1783452']
1976,32463741,Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W.,"PURPOSE


NCI-MATCH is a nationwide, histology-agnostic, signal-finding, molecular profile-driven trial for patients with refractory cancers, lymphomas, or myelomas. Patients with tumors harboring actionable aberration(s) in fibroblast growth factor receptor ( FGFR )  1-3  were treated with AZD4547, an oral FGFR1-3 inhibitor.
METHODS


Patients' tumors were screened by next-generation sequencing for predefined  FGFR  amplification, activating mutations, or fusions. Patients were treated with AZD4547, 80 mg orally twice daily until progression of disease or drug intolerance. A response rate of 16% was considered promising.
RESULTS


Between July 2016 and June 2017, 70 patients were assigned and 48 received protocol therapy and are eligible for analysis. Patients' tumors harbored  FGFR1  or  FGFR2  amplification (n = 20),  FGFR2  or  FGFR3  single-nucleotide variants (n = 19), or  FGFR1  or  FGFR3  fusions (n = 9). The most common primary tumors were breast (33.3%), urothelial (12.5%), and cervical cancer (10.4%).Grade 3 adverse events were consistent with those described in previous clinical trials. Confirmed partial responses were seen in 8% (90% CI, 3% to 18%) and were observed only in patients whose tumors harbored  FGFR1-3  point mutations or fusions. Stable disease was observed in 37.5% (90% CI, 25.8% to 50.4%). The median progression-free survival (PFS) was 3.4 months, and the 6-month PFS rate was 15% (90% CI, 8% to 31%). For patients with tumors harboring  FGFR  fusions, the response rate was 22% (90% CI, 4.1% to 55%), and 6-month PFS rate was 56% (90% CI, 31% to 100%).
CONCLUSION


Preliminary signals of activity appeared to be limited to cancers harboring  FGFR  activating mutations and fusions, although AZD4547 did not meet the primary end point. Different  FGFR  somatic alterations may confer different levels of signaling potency and/or oncogene dependence.",2020,FGFR3  ,"[""Patients' tumors were screened by next-generation sequencing for predefined  FGFR  amplification, activating mutations, or fusions"", 'Patients With Tumors Harboring Aberrations in the FGFR Pathway', ""Patients' tumors harbored  FGFR1  or  FGFR2  amplification (n = 20),  FGFR2  or"", 'patients with refractory cancers, lymphomas, or myelomas', 'Patients with tumors harboring actionable aberration(s', 'Between July 2016 and June 2017, 70 patients were assigned and 48 received']","['FGFR1  or  FGFR3  fusions', 'AZD4547', 'protocol therapy', 'FGFR3', 'AZD4547, an oral FGFR1-3 inhibitor', 'fibroblast growth factor receptor']","['Stable disease', 'median progression-free survival (PFS', 'cervical cancer', '6-month PFS rate', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0527057', 'cui_str': 'FGFR3 protein, human'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C2981795', 'cui_str': 'AZD4547'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",70.0,0.037636,FGFR3  ,"[{'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Chae', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Vaklavas', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Seattle Cancer Center Alliance, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hammerman', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Zwiebel', 'Affiliation': 'Investigational Drug Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'S Percy', 'Initials': 'SP', 'LastName': 'Ivy', 'Affiliation': 'Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McShane', 'Affiliation': 'Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Larry V', 'Initials': 'LV', 'LastName': 'Rubinstein', 'Affiliation': 'Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Patton', 'Affiliation': 'Center for Biomedical Informatics & Information Technology, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'P Mickey', 'Initials': 'PM', 'LastName': 'Williams', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Mansfield', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Conley', 'Affiliation': 'Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Lyndsay N', 'Initials': 'LN', 'LastName': 'Harris', 'Affiliation': 'Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Chen', 'Affiliation': 'Investigational Drug Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02630']
1977,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND


Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities.
METHODS


Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response.
RESULTS


We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus.
LIMITATIONS


Only young Chinese males without any trauma experience were recruited in this study.
CONCLUSIONS


The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123']
1978,32469819,Short and Long-Term Effects of Cannabis on Symptoms of Post-Traumatic Stress Disorder.,"BACKGROUND


Many individuals use cannabis to manage symptoms of post-traumatic stress disorder (PTSD), and evidence indicates that the endocannabinoid system represents a viable target for treating these symptoms.
METHOD


Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time. This sample collectively used the app 11,797 times over 31 months to track PTSD-related symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety) immediately before and after inhaling cannabis. Latent change score models were used to examine changes in symptom severity and predictors of these changes (gender, dose, cannabis constituents, time). Multilevel models were used to explore long-term consequences of repeatedly using cannabis to manage these symptoms.
RESULTS


All symptoms were reduced by more than 50% immediately after cannabis use. Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions. Higher doses of cannabis predicted larger reductions in intrusions and anxiety, and dose used to treat anxiety increased over time. Baseline severity of all symptoms remained constant across time.
LIMITATIONS


The sample was self-selected, self-identified as having PTSD, and there was no placebo control group.
CONCLUSIONS


Cannabis provides temporary relief from PTSD-related symptoms. However, it may not be an effective long-term remedy as baseline symptoms were maintained over time and dose used for anxiety increased over time, which is indicative of development of tolerance.",2020,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","['Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time']",['Cannabis'],"['intrusions and irritability', 'symptom relief', 'intrusions and anxiety, and dose used to treat anxiety', 'symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety']","[{'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0558066', 'cui_str': 'Intrusive thoughts'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks'}]",,0.0308863,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Glodosky', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bonn-Miller', 'Affiliation': 'The University of Pennsylvania Perelman School of Medicine, Department of Psychiatry, 3535 Market Street, Suite 500, Philadelphia, PA 19104.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.132']
1979,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES


Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults.
METHODS


Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual.
RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)].
DISCUSSION


The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054']
1980,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND


Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD.
METHODS


Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention.
RESULTS


The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected.
LIMITATIONS


The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study.
CONCLUSIONS


Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007']
1981,32471106,Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study.,"BACKGROUND


the aim of this study was to investigate the pharmacokinetic (PK) and safety profile of high-dose vitamin D supplementation, comparing different schedules (daily, weekly, or bi-weekly) in an otherwise healthy vitamin D-deficient population. Methods :  single-center, open-label study on healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL), randomized to receive cholecalciferol (DIBASE ® , Abiogen Pharma, Italy) using three different schedules: Group A: 10,000 IU/day for eight weeks followed by 1000 IU/day for four weeks; Group B: 50,000 IU/week for 12 weeks, Group C: 100,000 IU/every other week for 12 weeks. Total cumulative doses were: 588,000 IU, 600,000 IU, 600,000 IU. The treatment regimens corresponded to the highest doses allowed for cholecalciferol for the correction of vitamin D deficiency in adults in Italy.
RESULTS


mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C. On day 28, all subjects showed 25 (OH)D levels ≥ 20 ng/mL and 93.1% had 25 (OH)D levels ≥ 30 ng/mL. On day 56 and 84, all subjects had 25 (OH)D levels ≥ 30 ng/mL. No serious adverse events occurred during the study.
CONCLUSIONS


normalization of 25 (OH)D serum levels was quickly attained with all the studied regimens. A more refracted schedule provided a higher systemic 25 (OH)D exposure.",2020,"RESULTS


mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C.","['otherwise healthy vitamin D-deficient population', 'adults in Italy', 'healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL', 'Healthy Subjects with Vitamin D Deficiency']","['high-dose vitamin D supplementation', 'Oral Cholecalciferol', 'cholecalciferol (DIBASE ®', 'cholecalciferol']","['OH)D levels ≥', '25 (OH)D levels ≥', 'serious adverse events', 'normalization of 25 (OH)D serum levels', 'pharmacokinetic (PK) and safety profile', 'mean 25 (OH)D plasma levels']","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.0510382,"RESULTS


mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C.","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Fassio', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Adami', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Rossini', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Giollo', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Caimmi', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bixio', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Viapiana', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Milleri', 'Affiliation': 'Centro Ricerche Cliniche di Verona SRL, 37131 Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Gatti', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Gatti', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}]",Nutrients,['10.3390/nu12061553']
1982,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES


This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS


Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS


A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS


The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
1983,32473563,Exercise improves neurotrophins in multiple sclerosis independent of disability status.,"BACKGROUND


To date, studies examining the effect of exercise on neurotrophic factors in MS are contradictory, and this may be explained, in part, by moderators such as disability status. To investigating the effect of a 12-week (3sessions/week) supervised multimodal exercise program on neurotrophic factors levels.
METHODS


Ninety four women with MS were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS< 4.5), moderate (4.5 ≤EDSS≤ 6), or high (EDSS≥ 6.5) disability. The exercise program comprised resistance, endurance, Pilates, balance and stretch exercises. Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI) were evaluated before and after the intervention period.
RESULTS


Exercise training improved brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels. The effect of exercise on NT-3 was dependent on disability status such that exercise groups with low and high disability had more pronounced changes compared with other condition. There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF). Aerobic capacity and one-repetition maximum, but not PCI, were improved with exercise independent of disability status.
CONCLUSIONS


Exercise can stimulate neurotrophic production and secretion, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and its effect may not be moderated by disability status.",2020,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,['Ninety four women with MS'],"['Exercise', 'Exercise training', 'multimodal exercise program', 'exercise program comprised resistance, endurance, Pilates, balance and stretch exercises']","['Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI', 'ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF', 'brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels', 'Disability Status Scale (EDSS) scores', 'Aerobic capacity and one-repetition maximum']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0207071', 'cui_str': 'Ciliary Neuronotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0199456,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Performance and Health, Institute for Sport and Sport Science, Technical University Dortmund, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102143']
1984,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE


By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.
METHODS


This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.
CONCLUSION


This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047']
1985,32474156,Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis.,"BACKGROUND


Comorbid perennial allergic rhinitis (PAR) or year-round aeroallergen sensitivity substantially contributes to disease burden in patients with asthma. Dupilumab blocks the shared receptor for interleukin (IL) 4 and IL-13, key drivers of type 2 inflammation that play important roles in asthma and PAR. In the LIBERTY ASTHMA QUEST trial (NCT02414854), dupilumab reduced severe asthma exacerbations and improved forced expiratory volume in 1 second (FEV 1 ) in patients with uncontrolled, moderate-to-severe asthma, with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers at baseline (blood eosinophils and fractional exhaled nitric oxide).
OBJECTIVE


To assess dupilumab efficacy in LIBERTY ASTHMA QUEST patients with comorbid PAR.
METHODS


Severe asthma exacerbation rates, FEV 1 , asthma control (5-item Asthma Control Questionnaire), rhinoconjunctivitis-specific health-related quality of life (Standardized Rhinoconjunctivitis Quality of Life Questionnaire +12 scores), and type 2 inflammatory biomarkers during the 52-week treatment period were assessed.
RESULTS


A total of 814 of the 1902 patients (42.8%) had comorbid PAR (defined as an allergic rhinitis history and ≥1 perennial aeroallergen specific immunoglobulin E (IgE) level ≥0.35 kU/L at baseline). Dupilumab, 200 and 300 mg every 2 weeks, vs placebo reduced severe exacerbations rates by 32.2% and 34.6% (P < .05 for both) and improved FEV 1  at week 12 by 0.14 L and 0.18 L (P < .01 for both); greater efficacy was observed in patients with elevated baseline blood eosinophil counts (≥300 cells/μL) and fractional exhaled nitric oxide. Dupilumab treatment also numerically improved the 5-item Asthma Control Questionnaire and Standardized Rhinoconjunctivitis Quality of Life Questionnaire +12 scores and suppressed type 2 inflammatory biomarkers.
CONCLUSION


Dupilumab improved key asthma-related outcomes, asthma control, and rhinoconjunctivitis-specific health-related quality of life while suppressing type 2 inflammatory biomarkers and perennial allergen-specific IgE in patients with moderate-to-severe asthma and comorbid PAR, highlighting its dual inhibitory effects on IL-4 and IL-13 and its role in managing asthma and PAR.",2020,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","['asthma patients', 'patients with asthma and perennial allergic rhinitis', 'patients with moderate-to-severe asthma and comorbid PAR', 'patients had comorbid PAR', 'QUEST patients with comorbid PAR (allergic rhinitis history and ≥1 perennial aeroallergen-specific IgE ≥0.35 kU/L at baseline']","['Dupilumab', 'placebo']","['Severe asthma exacerbation rates, FEV1, asthma control (ACQ-5), rhinoconjunctivitis-specific health-related quality of life (HRQoL) (RQLQ[S]+12), and type 2 inflammatory biomarkers', 'forced expiratory volume', 'ACQ-5 and RQLQ(s)+12 scores, and suppressed type 2 inflammatory biomarkers', 'severe exacerbations rates', 'FEV1', 'dupilumab efficacy', 'efficacy']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0837837,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: wwb@medicine.wisc.edu.'}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': 'Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Texas Medical Center, Houston, Texas.'}, {'ForeName': 'Bradley E', 'Initials': 'BE', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, California.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Katelaris', 'Affiliation': 'Campbelltown Hospital and Western Sydney University, Campbelltown, Australia.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'The University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Ford', 'Affiliation': 'Asthma and Allergy Center, Bellevue, Nebraska.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Siddhesh', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jagerschmidt', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Harel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.026']
1986,32474584,Potentially inappropriate medication use in older adults with mild-moderate Alzheimer's disease: prevalence and associations with adverse events.,"AIM


Potentially inappropriate medication (PIM) use is prevalent in older adults and is associated with adverse events, hospitalisation and mortality. We assessed the patterns and associations of PIM use in older adults with mild-to-moderate Alzheimer's Disease (AD), who may represent a particularly vulnerable group.
DESIGN


Analysis of data from NILVad, an 18-month Randomised Control Trial of Nilvadapine in mild-to-moderate AD. The v2 STOPP criteria were applied in duplicate to identify PIM use. Associations between PIM use and adverse events/unscheduled healthcare visits in addition to the associations between PIM use and AD progression were evaluated.
SETTING AND PARTICIPANTS


448 older adults with mild-to-moderate AD from 23 centres in nine European countries.
RESULTS


Of 448 participants (mean age: 72.56 ± 8.19 years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs. The most frequent PIMs were (i) long-term benzodiazepines (11.6% N = 52/448), (ii) selective serotonin reuptake inhibitors without appropriate indication (11.1% N = 50/448), and (iii) Proton-Pump Inhibitors (PPIs) without appropriate indication (10.7% N = 48/448). Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001). PIM use was not associated with dementia progression.
CONCLUSIONS AND IMPLICATIONS


PIM use is highly prevalent in mild-to-moderate AD and is associated with adverse events and unscheduled healthcare utilisation. Further attention to de-prescribing in this vulnerable group is warranted.",2020,"Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001).","['448 older adults with mild-to-moderate AD from 23 centres in nine European countries', 'Of 448 participants (mean age: 72.56\u2009±\u20098.19\xa0years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs', 'older adults', ""older adults with mild-moderate Alzheimer's disease"", 'mild-to-moderate AD', ""older adults with mild-to-moderate Alzheimer's Disease (AD""]","['benzodiazepines', 'Nilvadapine', 'inappropriate medication (PIM']","['unscheduled hospitalisations', 'GP visits', 'serious adverse events', 'risk of adverse events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]","[{'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",448.0,0.0647382,"Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Adam H', 'Initials': 'AH', 'LastName': 'Dyer', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lawlor', 'Affiliation': 'Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Kennelly', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Age and ageing,['10.1093/ageing/afaa067']
1987,32482999,Ephedrine versus Phenylephrine Effect on Cerebral Blood Flow and Oxygen Consumption in Anesthetized Brain Tumor Patients: A Randomized Clinical Trial.,"BACKGROUND


Studies in anesthetized patients suggest that phenylephrine reduces regional cerebral oxygen saturation compared with ephedrine. The present study aimed to quantify the effects of phenylephrine and ephedrine on cerebral blood flow and cerebral metabolic rate of oxygen in brain tumor patients. The authors hypothesized that phenylephrine reduces cerebral metabolic rate of oxygen in selected brain regions compared with ephedrine.
METHODS


In this double-blinded, randomized clinical trial, 24 anesthetized patients with brain tumors were randomly assigned to ephedrine or phenylephrine treatment. Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen in peritumoral and normal contralateral regions were performed before and during vasopressor infusion. The primary endpoint was between-group difference in cerebral metabolic rate of oxygen. Secondary endpoints included changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation.
RESULTS


Peritumoral mean ± SD cerebral metabolic rate of oxygen values before and after vasopressor (ephedrine, 67.0 ± 11.3 and 67.8 ± 25.7 μmol · 100 g · min; phenylephrine, 68.2 ± 15.2 and 67.6 ± 18.0 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 1.5 [-13.3 to 16.3] μmol · 100 g · min [P = 0.839]). Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values (ephedrine, 90.8 ± 15.9 and 94.6 ± 16.9 μmol · 100 g · min; phenylephrine, 100.8 ± 20.7 and 96.4 ± 17.7 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 8.2 [-2.0 to 18.5] μmol · 100 g · min [P = 0.118]). Ephedrine significantly increased cerebral blood flow (difference [95% CI], 3.9 [0.7 to 7.0] ml · 100 g · min [P = 0.019]) and regional cerebral oxygen saturation (difference [95% CI], 4 [1 to 8]% [P = 0.024]) in the contralateral hemisphere compared to phenylephrine. The change in oxygen extraction fraction in both regions (peritumoral difference [95% CI], -0.6 [-14.7 to 13.6]% [P = 0.934]; contralateral hemisphere difference [95% CI], -0.1 [- 12.1 to 12.0]% [P = 0.989]) were comparable between groups.
CONCLUSIONS


The cerebral metabolic rate of oxygen changes in peritumoral and normal contralateral regions were similar between ephedrine- and phenylephrine-treated patients. In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.",2020,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","['Anesthetized Brain Tumor Patients', 'brain tumor patients', '24 anesthetized patients with brain tumors', 'anesthetized patients without cerebral pathology', 'adult patients with brain tumors', 'anesthetized patients']","['ephedrine- and phenylephrine', 'ephedrine or phenylepherine', 'phenylephrine and ephedrine', 'phenylephrine', 'ephedrine or phenylephrine', 'Phenylephrine', 'ephedrine', 'Ephedrine']","['cerebral metabolic rate of oxygen', 'Peritumoral mean ± SD cerebral metabolic rate of oxygen values', 'Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values', 'cerebral blood flow and cerebral metabolic rate of oxygen', 'cerebral blood flow and regional cerebral oxygen saturation', 'change in oxygen extraction fraction', 'Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen', 'contralateral hemisphere difference', 'Cerebral Blood Flow and Oxygen Consumption', 'cerebral blood flow', 'regional cerebral oxygen saturation', 'cerebral metabolic rate of oxygen changes', 'changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation']","[{'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.583823,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","[{'ForeName': 'Klaus U', 'Initials': 'KU', 'LastName': 'Koch', 'Affiliation': 'From the Department of Anesthesiology, Section of Neuroanesthesia (K.U.K., N.J., L.N., M.R.) Department of Nuclear Medicine and PET Center (J.A.) Department of Neurosurgery (G.v.O.) Department of Neuroradiology (L.Ø.), Aarhus University Hospital, Aarhus, Denmark Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark (I.K.M., L.Ø.) Department of Anesthesiology, Horsens Regional Hospital, Horsens, Denmark (U.S.E.) Institute of Neuroradiology, Charité, Universitätsmedizin, Berlin, Germany (A.T.).'}, {'ForeName': 'Irene K', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Aanerud', 'Affiliation': ''}, {'ForeName': 'Ulrick S', 'Initials': 'US', 'LastName': 'Espelund', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tietze', 'Affiliation': ''}, {'ForeName': 'Gorm V', 'Initials': 'GV', 'LastName': 'Oettingen', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': ''}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003377']
1988,32483861,"L-Dex, arm volume, and symptom trajectories 24 months after breast cancer surgery.","PURPOSE


Study objectives were to examine: (a) biomarker trajectories (change from presurgical baseline values of Lymphedema index (L-Dex) units and arm volume difference) and symptom cluster scores 24 months after breast cancer surgery and (b) associations of these objective biomarkers and symptom cluster scores. Patient/treatment characteristics influencing trajectories were also evaluated.
METHODS


A secondary analysis of data from the published interim analysis of a randomized parent study was undertaken using trajectory analysis. Five hundred and eight participants included in the prior analysis with 24 months of postsurgical follow-up were initially measured with bioelectric impedance spectroscopy (BIS) and tape measure (TM) and completed self-report measures. Patients were reassessed postsurgery for continuing eligibility and then randomized to either BIS or TM groups and measured along with self-report data at regular and optional* visits 3, 6,12,15*,18, 21*, and 24-months.
RESULTS


Three subclinical trajectories were identified for each biomarker (decreasing, stable, increasing) and symptom cluster scores (stable, slight increase/decrease, increasing). Subclinical lymphedema was identified throughout the 24-month period by each biomarker. An L-Dex increase at 15 months in the BIS group was noted. The self-report sets demonstrated contingency coefficients of 0.20 (LSIDS-A soft tissue, P = .031) and 0.19 (FACTB+4, P = .044) with the L-Dex unit change trajectories.
CONCLUSIONS


These data support the need for long-term (24 months) prospective surveillance with frequent assessments (every 3 months) at least 15 months after surgery. Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.",2020,Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.,['Five hundred and eight participants included in the prior analysis with 24\xa0months of postsurgical follow-up were initially measured with'],['BIS or TM'],"['bioelectric impedance spectroscopy (BIS) and tape measure (TM) and completed self-report measures', 'Subclinical lymphedema']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C2936361', 'cui_str': 'Impedance Spectroscopy'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}]","[{'cui': 'C2936361', 'cui_str': 'Impedance Spectroscopy'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]",508.0,0.0250319,Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.,"[{'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Vanderbilt University School of Nursing, Nashville, TN, USA.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boyages', 'Affiliation': 'Australian Lymphoedema Education, Research, and Treatment (ALERT) Program, Faculty of Medicine & Health Sciences, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Koelmeyer', 'Affiliation': 'ALERT Program, Faculty of Medicine & Health Sciences, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Ajkay', 'Affiliation': 'Breast Surgical Oncology, University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'DeSnyder', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'McLaughlin', 'Affiliation': 'Surgery, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Vanderbilt University School of Nursing and Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Cancer medicine,['10.1002/cam4.3188']
1989,32592589,The Agents Intervening against Delirium in the Intensive Care Unit Trial (AID-ICU trial): A detailed statistical analysis plan.,"BACKGROUND


The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial.
METHODS


The AID-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomized, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomization. Secondary outcome measures are days alive without delirium or coma, serious adverse reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomization. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables.
CONCLUSION


The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.",2020,"Secondary outcome measures are days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation.","['delirium in acutely admitted, adult intensive care unit (ICU) patients', '1000 adult ICU patients with manifest delirium 1:1 to', 'acutely admitted, adult patients with manifest delirium in the ICU']","['haloperidol or placebo', 'haloperidol']","['days alive and out of hospital within 90 days post-randomisation', 'stratification variables (site and delirium motor subtype', 'days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1000.0,0.342267,"Secondary outcome measures are days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Andersen-Ranberg', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Lone M', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Camilla B', 'Initials': 'CB', 'LastName': 'Mortensen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Estrup', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Bjørn H', 'Initials': 'BH', 'LastName': 'Ebdrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research (CNSR) & Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anaesthesiology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Citerio', 'Affiliation': 'Universitá Milano Bicocca, Monza, Italy.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Caballero', 'Affiliation': 'Hospital Universitari Arnau de Vilanova de Lleida, IRBLLeida, Departament de Medicina, Universitat Autònoma de Barcelona-UAB, Barcelona, Spain.'}, {'ForeName': 'Matthew P G', 'Initials': 'MPG', 'LastName': 'Morgan', 'Affiliation': 'Adult Critical Care, University of Wales, Cardiff, Wales.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Oxenbøll-Collet', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sven-Olaf', 'Initials': 'SO', 'LastName': 'Weber', 'Affiliation': 'General Intensive Care Unit, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sofie Andreasen', 'Affiliation': 'Intensive Care Unit, Dept. of Anesthesiology and Intensive Care, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Helle B S', 'Initials': 'HBS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Nykøbing Falster Hospital, Nykøbing, Denmark.'}, {'ForeName': 'Louise G', 'Initials': 'LG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Intensive Care, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Uslu', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Troels B', 'Initials': 'TB', 'LastName': 'Jensen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Thee', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Sønderjylland, Aabenraa, Denmark.'}, {'ForeName': 'Nilanjan', 'Initials': 'N', 'LastName': 'Dey', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Unit West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13661']
1990,31875646,GDF15 mediates the effects of metformin on body weight and energy balance.,"Metformin, the world's most prescribed anti-diabetic drug, is also effective in preventing type 2 diabetes in people at high risk 1,2 . More than 60% of this effect is attributable to the ability of metformin to lower body weight in a sustained manner 3 . The molecular mechanisms by which metformin lowers body weight are unknown. Here we show-in two independent randomized controlled clinical trials-that metformin increases circulating levels of the peptide hormone growth/differentiation factor 15 (GDF15), which has been shown to reduce food intake and lower body weight through a brain-stem-restricted receptor. In wild-type mice, oral metformin increased circulating GDF15, with GDF15 expression increasing predominantly in the distal intestine and the kidney. Metformin prevented weight gain in response to a high-fat diet in wild-type mice but not in mice lacking GDF15 or its receptor GDNF family receptor α-like (GFRAL). In obese mice on a high-fat diet, the effects of metformin to reduce body weight were reversed by a GFRAL-antagonist antibody. Metformin had effects on both energy intake and energy expenditure that were dependent on GDF15, but retained its ability to lower circulating glucose levels in the absence of GDF15 activity. In summary, metformin elevates circulating levels of GDF15, which is necessary to obtain its beneficial effects on energy balance and body weight, major contributors to its action as a chemopreventive agent.",2020,"In wild-type mice, oral metformin increased circulating GDF15, with GDF15 expression increasing predominantly in the distal intestine and the kidney.",[],"['oral metformin', 'Metformin', 'metformin']","['circulating GDF15, with GDF15 expression', 'body weight', 'weight gain', 'energy intake and energy expenditure', 'body weight and energy balance']",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0132908,"In wild-type mice, oral metformin increased circulating GDF15, with GDF15 expression increasing predominantly in the distal intestine and the kidney.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Coll', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. apc36@cam.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Pranali', 'Initials': 'P', 'LastName': 'Taskar', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Rimmington', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Tadross', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cimino', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Virtue', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Goldspink', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Miedzybrodzka', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Konopka', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Raul Ruiz', 'Initials': 'RR', 'LastName': 'Esponda', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jeffrey T-J', 'Initials': 'JT', 'LastName': 'Huang', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Y C Loraine', 'Initials': 'YCL', 'LastName': 'Tung', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Rodriguez-Cuenca', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Rute A', 'Initials': 'RA', 'LastName': 'Tomaz', 'Affiliation': 'Wellcome -Medical Research Council Cambridge Stem Cell Institute, Department of Surgery, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Heather P', 'Initials': 'HP', 'LastName': 'Harding', 'Affiliation': 'Cambridge Institute for Medical Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Melvin', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Giles S H', 'Initials': 'GSH', 'LastName': 'Yeo', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Preiss', 'Affiliation': 'MRC Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vidal-Puig', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Vallier', 'Affiliation': 'Wellcome -Medical Research Council Cambridge Stem Cell Institute, Department of Surgery, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ron', 'Affiliation': 'Cambridge Institute for Medical Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Savage', 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Bernard B', 'Initials': 'BB', 'LastName': 'Allan', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': ""O'Rahilly"", 'Affiliation': 'MRC Metabolic Diseases Unit, Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. so104@medschl.cam.ac.uk.'}]",Nature,['10.1038/s41586-019-1911-y']
1991,32473356,Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.,"BACKGROUND


Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y 12  receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting.
METHODS


Assessment of Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier).
CONCLUSION


ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.",2020,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"['patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290', 'patients with stable coronary artery disease who are planned for an elective PCI', '1,900 patients', 'patients undergoing elective percutaneous coronary intervention (PCI']","['Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel', 'ticagrelor 180 mg or a loading dose of clopidogrel', 'aspirin', 'aspirin and ticagrelor 90 mg twice daily or clopidogrel']","['PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier', 'periprocedural ischemic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",1900.0,0.0455808,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen-Département de Cardiologie; Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'CH de Chartres-Département de Cardiologie, Chartes, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Jean-Guillaume', 'Initials': 'JG', 'LastName': 'Dillinger', 'Affiliation': 'Department of Cardiology, Inserm U942, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris, Paris, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'CH de Bastia-Département de Cardiologie, Bastia, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Clinique Sainte Clotilde, La Réunion-Département de Cardiologie, La Réunion, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Christiaens', 'Affiliation': 'CHU de Poitiers-Service de Cardiologie, Poitiers, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Labeque', 'Affiliation': 'GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'CHU de Toulouse-Département de Cardiologie, Toulouse, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Georges', 'Affiliation': 'CH de Versailles-Service de Cardiologie, Hôpital A. Mignot, Le Chesnay, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellemain-Appaix', 'Affiliation': ""CH d'Antibes Juan-Les-Pins-Département de Cardiologie, Antibes Juan-Les-Pins, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Breton', 'Affiliation': 'Univ Rennes, CHU Rennes, Inserm LTSI U1099, Rennes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'CHU Ambroise Paré (APHP), Université Versailles-Saint Quentin, ACTION study Group, INSERM-U1018 CESP, Boulogne, France-Service de Cardiologie.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint-Etienne', 'Affiliation': 'CHU Trousseau, Tours-Département de Cardiologie, Tours, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Institut Mutualiste Montsouris-Département de Cardiologie, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jourda', 'Affiliation': 'CH Auxerre-Département de Cardiologie, Auxerre, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': '3rd Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Kasty', 'Affiliation': ""Grand Hôpital de l'Est Francilien site Marne-La-Vallée - Département de Cardiologie, Marne La Vallée, France.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Dumaine', 'Affiliation': 'Les Grands Prés Cardiac Rehabilitation center, Villeneuve St Denis, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), DHU FIRE, Hôpital Bichat, AP-HP, Université de Paris, Inserm U-1148, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique, ACTION Study Group, Hôpital Fernand Widal (AP-HP), Paris, France; SAMM - Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.017']
1992,32473365,Central nervous system activities of extract Mangifera indica L.,"ETHNOBOTANICAL RELEVANCE


Leaves of Mangifera indica L. have folk-uses in tropical regions of the world as health teas, as a remedy for exhaustion and fatigue, as a vegetable, and as a medicine. Mangifera indica leaf extract (MLE) had previously been demonstrated to alter brain electrical activity in-vivo. The aim of the present series of studies was to investigate whether mangiferin, a major compound in leaves and in MLE, is responsible for the neurocognitive activity of MLE, and if the CNS activities of MLE have translational potential.
MATERIALS AND METHODS


MLE, tradename Zynamite, is produced by Nektium Pharma, Spain. Isolated mangiferin was tested in-vitro in radioligand binding and enzyme inhibition studies against 106 CNS targets. Changes in the electroencephalograms (EEG's) of MLE and mangiferin were recorded in-vivo from four brain regions. Two double blind randomized placebo-controlled crossover clinical trials were conducted, each with 16 subjects. At 90 min and at 60 min respectively, after oral intake of 500 mg MLE, EEG recordings, psychometric tests, mood state, and tolerability were studied.
RESULTS


Isolated mangiferin is a selective inhibitor of catechol-O-methyltransferase (COMT) with an IC50 of 1.1 μM, with no activity on the CNS targets of caffeine. Both mangiferin and MLE induce similar changes in long-term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo. In both translational clinical trials MLE was well tolerated, with no cardiovascular side-effects. In both studies MLE caused significant spectral changes in brain electrical activity in cortical regions during cognitive challenges, different to the attenuated spectral changes induced by caffeine. There were no significant changes in the psychometric tests other than reaction time for all groups. In the second study there was a trend to faster reaction time within group for MLE (p = 0.066) and the percentage improvement in reaction time for MLE compared to placebo was significant (p = 0.049). In the first study MLE improved all scores for Profile of Mood States (POMS), with the score for ""fatigue"" significantly improved (p = 0.015); in the second study the POMS score for ""dejection"" was improved in the caffeine group, p = 0.05.
CONCLUSIONS


Mangiferin is a COMT inhibitor of moderate potency and is the major CNS-active compound in MLE. Both mangiferin and MLE increase hippocampal LTP in-vitro, and induce a similar pattern of changes in brain electrical activity in-vivo. While the translational clinical trials of MLE are limited by being single dose studies in a small number of subjects, they provide the first clinical evidence that the extract is well tolerated with no cardiovascular side-effects, can induce changes in brain electrical activity, may give a faster reaction time, and decrease fatigue. These CNS activities support the reported folk-uses use of mango leaf tea as a substitute for tea and as a traditional remedy for fatigue and exhaustion. Extract Mangifera indica L., Zynamite, has nootropic potential, and larger clinical studies are needed to realise this potential.",2020,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.",['16 subjects'],"['Mangifera indica leaf extract (MLE', 'caffeine', 'mangiferin and MLE', 'MLE', 'extract Mangifera indica L', 'placebo']","['fatigue', 'POMS score for ""dejection', 'Profile of Mood States (POMS', 'brain electrical activity', 'psychometric tests, mood state, and tolerability', 'reaction time for MLE', 'faster reaction time']",[],"[{'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0364453,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: llopez@nektium.com.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: jwiebe@nektium.com.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: tvega@nektium.com.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gericke', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain; Department of Botany and Plant Biotechnology, University of Johannesburg, Auckland Park, 2006, Johannesburg, South Africa. Electronic address: ngericke@nektium.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112996']
1993,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
1994,32478474,Tofacitinib in the treatment of Indian patients with rheumatoid arthritis: A post hoc analysis of efficacy and safety in Phase 3 and long-term extension studies over 7 years.,"OBJECTIVES


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized tofacitinib efficacy/safety in Indian vs rest of the world (ROW; excluding India) RA patients.
METHODS


Efficacy data were pooled for disease-modified antirheumatic drug (DMARD) inadequate responders from Phase (P)3 studies. For Indian patients, ORAL Solo and ORAL Scan; ROW (excluding India), these studies plus ORAL Step, ORAL Sync, and ORAL Standard. Safety data also included ORAL Start (P3; methotrexate-naïve) and ORAL Sequel (long-term extension [LTE] study; data cut-off March 2017) for Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW. Efficacy outcomes at months 3/6: American College of Rheumatology (ACR)20/50/70; Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission/low disease activity; change from baseline in Health Assessment Questionnaire-Disability Index. Incidence rates (IRs; patients with events/100 patient-years) for adverse events of special interest (AESIs) were assessed throughout. Descriptive data underwent no formal comparison.
RESULTS


One-hundred-and-ninety-seven Indian and 3879 ROW patients were included. Compared with ROW patients, Indian patients were younger, had lower body mass index, shorter RA duration, and higher baseline disease activity; most Indian patients were non-smokers and all were biologic DMARD (bDMARD)-naïve. Month 3 ACR20 rates with tofacitinib 5 mg twice daily/10 mg twice daily/placebo were 67.4%/82.1%/40.9% (India) and 59.0%/66.1%/28.2% (ROW), and month 6 rates were 76.2%/92.1%/88.9% (India) and 69.0%/74.2%/66.5% (ROW). Month 3/6 improvements in other outcomes were generally numerically greater with tofacitinib vs placebo, and similar in both populations. Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25).
CONCLUSIONS


Tofacitinib efficacy/safety were similar in both populations, except TB IR, which was higher in Indian patients but in line with those in bDMARD-treated RA patients from high-risk countries (IR = 0.00-2.56; TB IR >0.05 [World Health Organization]). Limitations included the small Indian population and baseline differences between populations.",2020,"Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25).
","['Indian vs rest of the world (ROW; excluding India) RA patients', 'Indian patients with rheumatoid arthritis', 'Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW', 'disease-modified antirheumatic drug\xa0(DMARD) inadequate responders from Phase (P)3 studies', 'rheumatoid arthritis (RA', 'One-hundred-and-ninety-seven Indian and 3879 ROW patients were included']","['placebo', 'Tofacitinib', 'ORAL Start (P3; methotrexate-naïve) and ORAL Sequel (long-term extension [LTE', 'tofacitinib 5\xa0mg twice daily/10']","['ACR20 rates', 'tuberculosis (TB) IR', 'adverse events of special interest (AESIs', 'lower body mass index, shorter RA duration, and higher baseline disease activity', 'Incidence rates', 'biologic DMARD (bDMARD)-naïve', 'Tofacitinib efficacy/safety', 'Health Assessment Questionnaire-Disability Index']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0064855', 'cui_str': 'Leukotriene E'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0064855', 'cui_str': 'Leukotriene E'}, {'cui': 'C3505040', 'cui_str': 'tofacitinib 5 MG'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.170653,"Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25).
","[{'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Chopra', 'Affiliation': 'Arthritis Research and Care Foundation, Center for Rheumatic Diseases, Pune, India.'}, {'ForeName': 'Vineeta', 'Initials': 'V', 'LastName': 'Shobha', 'Affiliation': ""St. John's Medical College Hospital, Bangalore, India.""}, {'ForeName': 'Srikantiah', 'Initials': 'S', 'LastName': 'Chandrashekara', 'Affiliation': 'ChanRe Rheumatology & Immunology Center & Research, Bangalore, India.'}, {'ForeName': 'Sarath C M', 'Initials': 'SCM', 'LastName': 'Veeravalli', 'Affiliation': 'Krishna Institute of Medical Sciences, Hyderabad, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Swastik Rheumatology Clinic, Ahmedabad, India.'}, {'ForeName': 'Uppuluri R', 'Initials': 'UR', 'LastName': 'Rao', 'Affiliation': 'Sri Deepti Rheumatology Center, Hyderabad, India.'}, {'ForeName': 'Sapan', 'Initials': 'S', 'LastName': 'Pandya', 'Affiliation': 'Rheumatic Diseases Clinic, Vedanta Institute of Medical Science, Ahmedabad, India.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Wagh', 'Affiliation': 'Jehangir Clinical Development Center, Maharashtra, India.'}, {'ForeName': 'Jugal K', 'Initials': 'JK', 'LastName': 'Kadel', 'Affiliation': 'Mahavir Hospital & Research Center, Hyderabad, India.'}, {'ForeName': 'Amit V', 'Initials': 'AV', 'LastName': 'Thorat', 'Affiliation': 'Pfizer Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Adhav', 'Affiliation': 'Pfizer Inc, Mumbai, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Santos Estrella', 'Affiliation': 'Pfizer Inc, Makati City, Philippines.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Pfizer Inc, Beijing, China.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13853']
1995,32474204,Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China.,"BACKGROUND


Venous thromboembolism (VTE) is a life-threatening disease that can affect each hospitalized patient. But the current in-hospital thromboprophylaxis remains suboptimal and there exists a large gap between clinical practice and guideline-recommended care in China.
METHODS


To facilitate implementation of guideline recommendations, we conduct a multicenter, adjudicator-blinded, cluster-randomized clinical trial, aiming to assess the effectiveness of a system-wide multifaceted quality improvement (QI) strategy on VTE prophylaxis improvement and thromboembolism reduction in clinical setting. Hospitals are randomized into intervention or control group. In intervention group, hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education. In control, hospitals receive the concept of recommended prophylaxis alone without QI. Thromboprophylaxis will be at the discretion of hospitals and conducted as usual. With a final sample size of 5760 hospitalized patients in 32 hospitals on mainland China, this trial will examine the effect of QI on improvement in thromboprophylaxis and patient-centered outcomes. This is an open-label trial that patients and healthcare professionals will know group allocation after enrollment, but endpoint adjudicators and statisticians will be blinded. RCT# NCT04211181 CONCLUSIONS: The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.",2020,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","['hospitalized patients using a', '5760 hospitalized patients in 32 hospitals on mainland China', 'hospitalized patients in China']","['system-wide multifaceted quality improvement intervention', 'hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education', 'system-wide multifaceted quality improvement (QI) strategy', 'RCT']",[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]",[],5760.0,0.127351,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Zhen', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chaozeng', 'Initials': 'C', 'LastName': 'Si', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiefeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Tieshan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Medical Affairs Department of China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Cunbo', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guangliang', 'Initials': 'G', 'LastName': 'Shan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, School of Basic Medicine, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China. Electronic address: zhaizhenguo2011@126.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.020']
1996,32474206,"The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation.","BACKGROUND


Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need.
METHODS


The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD.
CONCLUSION


INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.",2020,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"['pregnant women with RHD', 'patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2', 'rheumatic valvular disease and atrial fibrillation', '17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years', 'patients with valvular AF', 'enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America', 'Patients with RHD and AF', 'patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry', '4500 patients comparing']","['rivaroxaban with vitamin K antagonists (VKA', 'vitamin K antagonists', 'VKAs, rivaroxaban or aspirin', 'rivaroxaban', 'VKA']",['composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0264757', 'cui_str': 'Rheumatic disease of heart valve'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517780', 'cui_str': '4500'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",4565.0,0.080112,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"[{'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Karthikeyan', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India. Electronic address: karthik2010@gmail.com.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sumathy', 'Initials': 'S', 'LastName': 'Rangarajan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yun', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Fathi', 'Initials': 'F', 'LastName': 'Maklady', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Elghamrawy', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Khawar', 'Initials': 'K', 'LastName': 'Kazmi', 'Affiliation': 'Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Tantchou T J', 'Initials': 'TTJ', 'LastName': 'Cabral', 'Affiliation': 'St. Elizabeth Catholic General Hospital, Cameroon.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Dayi', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Changsheng', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Gitura', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, Sao Paolo, Brazil.'}, {'ForeName': 'Liesl', 'Initials': 'L', 'LastName': 'Zuhlke', 'Affiliation': 'Red Cross War Memorial Childrens Hospital, Cape Town, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lwabi', 'Affiliation': 'Uganda Heart Institute, Kampala, Uganda.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Haileamlak', 'Affiliation': 'Jimma University Hospital, Ethiopia.'}, {'ForeName': 'Okechukwu', 'Initials': 'O', 'LastName': 'Ogah', 'Affiliation': 'University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Pilly', 'Initials': 'P', 'LastName': 'Chillo', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paniagua', 'Affiliation': 'Barrio Obrero Hospital Asunción, Paraguay.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'ElSayed', 'Affiliation': 'Alzaeim Alazhari University, Khartoum, Sudan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dans', 'Affiliation': 'Philippines General Hospital, Manila, Philippines.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Gondwe-Chunda', 'Affiliation': 'Kamuzu Central Hospital, Malawi.'}, {'ForeName': 'Onkabetse Julia', 'Initials': 'OJ', 'LastName': 'Molefe-Baikai', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Jesus A', 'Initials': 'JA', 'LastName': 'Gonzalez-Hermosillo', 'Affiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Albertino', 'Initials': 'A', 'LastName': 'Damasceno', 'Affiliation': 'Maputo Central Hospital, Maputo, Mozambique.'}, {'ForeName': 'Emmanuel R', 'Initials': 'ER', 'LastName': 'Kamanzi', 'Affiliation': 'University Teaching Hospital of Kigali, Rwanda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Musuku', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Kairat', 'Initials': 'K', 'LastName': 'Davletov', 'Affiliation': 'Al-Farabi Kazakh National University, Almaty, Kazakhstan.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Bongani M', 'Initials': 'BM', 'LastName': 'Mayosi', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.03.018']
1997,32480076,Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset.,"The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3-5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.",2020,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","['Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study', 'Patients with first-ever stroke and requiring a walking aid started gait training within 1\xa0week of stroke onset', 'patients with acute stroke']","['Gait training using HAL', 'gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI', 'robot-assisted gait training', 'conventional physical therapy (CPT) group or gait training using HAL (HAL', 'gait training with Hybrid Assistive Limb']","['Motor function and DTI', 'changes in FA (ΔFA', 'contra-lesional rostrum of the corpus callosum', 'motor function and independency', 'FA in the ipsi-lesional cerebral peduncle']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0152322', 'cui_str': 'Structure of rostrum of corpus callosum'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}]",27.0,0.0293157,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yokota', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; Department of Stroke Rehabilitation, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: cyokota@ncvc.go.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Koshino', 'Affiliation': 'Department of Systems and Informatics, Hokkaido Information University, Ebetsu, Japan. Electronic address: koshino@do-johodai.ac.jp.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Yasuno', 'Affiliation': 'Department of Psychiatry, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan. Electronic address: yasunof@ncgg.go.jp.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Industrial-Academic Collaboration, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: ayamamot@ncvc.go.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Odani', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. Electronic address: nakajima.takashi.ud@mail.hosp.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nuclear Medicine and Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Tatsumi', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: tatsumi@ncvc.go.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116939']
1998,32481487,"Cardiometabolic Benefits of a Weight-Loss Mediterranean Diet/Lifestyle Intervention in Patients with Obstructive Sleep Apnea: The ""MIMOSA"" Randomized Clinical Trial.","Although continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA), its cardiometabolic benefits are questionable. Our aim was to explore whether the combination of a weight-loss Mediterranean diet/lifestyle intervention with OSA standard care leads to greater cardiometabolic improvements compared with standard care alone. We randomly assigned 187 adult, overweight, polysomnography-diagnosed moderate-to-severe OSA patients to a standard care group (SCG,  n  = 65), a Mediterranean diet group (MDG,  n  = 62) or a Mediterranean lifestyle group (MLG,  n  = 60). All three groups were prescribed with CPAP. Additionally, the SCG only received brief written healthy lifestyle advice, while intervention arms were subjected to a six-month weight-loss behavioral intervention based on the Mediterranean diet. The MLG also received guidance for improving physical activity and sleep habits. Glucose metabolism indices, blood lipids, liver enzymes and blood pressure improved only in intervention arms, and were significantly lower compared to the SCG post-intervention (all  p  < 0.05). The age-, sex-, baseline- and CPAP use-adjusted relative risk (95% confidence interval) of metabolic syndrome was 0.58 (0.34-0.99) for the MDG and 0.30 (0.17-0.52) for the MLG compared to the SCG. The MLG additionally presented a lower relative risk of metabolic syndrome compared to the MDG (0.52 (0.30-0.89)). After further adjustment for body-weight change, a lower relative risk of metabolic syndrome was still evident for the MLG compared to the SCG. In conclusion, although standard care alone does not improve OSA patients' cardiometabolic profile, its combination with a weight-loss Mediterranean diet/lifestyle intervention leads to significant cardiometabolic benefits.",2020,"Glucose metabolism indices, blood lipids, liver enzymes and blood pressure improved only in intervention arms, and were significantly lower compared to the SCG post-intervention (all  p  < 0.05).","['obstructive sleep apnea (OSA', 'Patients with Obstructive Sleep Apnea', '187 adult, overweight, polysomnography-diagnosed moderate-to-severe OSA patients to a']","['weight-loss Mediterranean diet/lifestyle intervention with OSA standard care', 'CPAP', 'SCG only received brief written healthy lifestyle advice, while intervention arms were subjected to a six-month weight-loss behavioral intervention based on the Mediterranean diet', 'standard care group (SCG,  n  = 65), a Mediterranean diet group (MDG,  n  = 62) or a Mediterranean lifestyle group (MLG,  n  = 60', 'continuous positive airway pressure (CPAP', 'Weight-Loss Mediterranean Diet/Lifestyle Intervention']","['Glucose metabolism indices, blood lipids, liver enzymes and blood pressure', 'physical activity and sleep habits', 'relative risk of metabolic syndrome', 'metabolic syndrome']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn sodium'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024443', 'cui_str': 'Madagascar'}, {'cui': 'C0574375', 'cui_str': 'Malagasy language'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",187.0,0.0194322,"Glucose metabolism indices, blood lipids, liver enzymes and blood pressure improved only in intervention arms, and were significantly lower compared to the SCG post-intervention (all  p  < 0.05).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Georgoulis', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Yiannakouris', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kechribari', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Lamprou', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, 45-47 Ipsilantou str., 10676 Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Perraki', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, 45-47 Ipsilantou str., 10676 Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Vagiakis', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, 45-47 Ipsilantou str., 10676 Athens, Greece.'}, {'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12061570']
1999,32481557,"Consumption of Biscuits with a Beverage of Mulberry or Barley Leaves in the Afternoon Prevents Dinner-Induced High, but Not Low, Increases in Blood Glucose among Young Adults.","We examined the impact of consuming biscuits with a beverage of powdered mulberry or barley leaves in the afternoon on postprandial glucose levels at dinnertime among young adults. A total of 18 young adults participated in a partially double-blinded, randomized crossover trial over 2 weeks, consuming either: (1) no biscuits; (2) a biscuit; (3) a biscuit with a beverage of powdered mulberry leaves; or (4) a biscuit with a beverage of powdered barley leaves, as an afternoon snack followed by a standardized test dinner. Glucose levels were recorded after each meal. Results showed intake of biscuits with a beverage of mulberry and barley leaves significantly reduced postprandial rises in glucose after their immediate consumption and dinner, though there was no direct relationship between the glucose levels at the two meals. Compared to those with low glucose levels, participants with high glucose levels at dinner showed a stronger second meal effect, that was attributed to the mulberry or barley leaves, and were also more likely to have lean body weights and prefer evenings. Our findings indicate that eating snacks alongside mulberry or barley leaves is an effective way to suppress postprandial glucose levels in young adults with high glucose levels who prefer evenings.",2020,"Compared to those with low glucose levels, participants with high glucose levels at dinner showed a stronger second meal effect, that was attributed to the mulberry or barley leaves, and were also more likely to have lean body weights and prefer evenings.","['young adults with high glucose levels who prefer evenings', 'young adults', '18 young adults', 'Young Adults']",[],"['Glucose levels', 'Blood Glucose', 'postprandial glucose levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0587117', 'cui_str': 'Evening'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}]",18.0,0.0253372,"Compared to those with low glucose levels, participants with high glucose levels at dinner showed a stronger second meal effect, that was attributed to the mulberry or barley leaves, and were also more likely to have lean body weights and prefer evenings.","[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Kuwahara', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hyeon-Ki', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nanba', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Chijiki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Fukazawa', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Okubo', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Mineshita', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Institute for Liberal Arts, Tokyo Institute of Technology, 2-12-1 Ookayama Meguro-ku, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}]",Nutrients,['10.3390/nu12061580']
2000,32486025,"Compression Stocking Length Effects on Oedema, Pain, and Satisfaction in Nursing Students: A Pilot Randomized Trial.","Professional practitioners who are required to stand for long periods of time frequently complain about vein-related symptoms. Compression stocking are effective for vein-related symptoms, but there is not enough evidence on the effect of the length of compression stockings for nursing students. To compare oedema, pain, and satisfaction according to different lengths of compression stockings worn by female nursing students. This study was conducted as a randomized clinical trial. The participants included 20 female nursing students in their first semester of clinical practice training. Compression stockings with 25-32 mmHg pressure were used in the study; the participants were divided into two groups based on the length of compression stocking: knee length and thigh length. Differences between groups regarding pain, oedema, and satisfaction were analysed using t-tests, paired t-tests, and Mann-Whitney U tests, when appropriate. There were no significant differences in pain, oedema, and satisfaction between the two groups. However, pain in right legs of the thigh-length stocking group significantly increased after clinical training shift compared with that before the shift (t = -2.377,  p  = 0.041). Both groups reported high satisfaction. There were no differences in pain, oedema, and satisfaction in both legs based on the length of compression stockings, but side effects appeared in participants wearing the thigh-length stockings; nevertheless, satisfaction was high in both groups. It may be important to suggest nursing students to wear knee-length compression stockings during clinical practice training.",2020,"There were no differences in pain, oedema, and satisfaction in both legs based on the length of compression stockings, but side effects appeared in participants wearing the thigh-length stockings; nevertheless, satisfaction was high in both groups.","['participants included 20 female nursing students in their first semester of clinical practice training', 'Professional practitioners', 'Nursing Students', 'female nursing students']","['Compression stocking', 'Compression stockings']","['Oedema, Pain, and Satisfaction', 'pain, oedema, and satisfaction', 'oedema, pain, and satisfaction', 'satisfaction', 'pain in right legs', 'pain, oedema, and satisfaction in both legs based on the length of compression stockings']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038348', 'cui_str': 'Compression stocking'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0564823', 'cui_str': 'Pain in right lower limb'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}]",20.0,0.0330258,"There were no differences in pain, oedema, and satisfaction in both legs based on the length of compression stockings, but side effects appeared in participants wearing the thigh-length stockings; nevertheless, satisfaction was high in both groups.","[{'ForeName': 'Yoonyoung', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Sunchon National University, Suncheon, Jeollanam-do 57922, Korea.'}, {'ForeName': 'Kisook', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Chung-Ang University, Seoul 06974, Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Korea University Ansan Medicine, Ansan, Geyonggi-do 15355, Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Kyunghee University Medical Center, Seoul 02447, Korea.'}, {'ForeName': 'Su Gyeong', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Sunchon National University, Suncheon, Jeollanam-do 57922, Korea.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Army Nurse, Korea Army, Korea.'}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Department of Nursing, Asan Medical Center, Seoul 05505, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020149']
2001,32486256,Docosahexaenoic Acid-Rich Fish Oil Supplementation Reduces Kinase Associated with Insulin Resistance in Overweight and Obese Midlife Adults.,"Targeting kinases linked to insulin resistance (IR) and inflammation may help in reducing the risk of type 2 diabetes (T2D) and Alzheimer's disease (AD) in its early stages. This study aimed to determine whether DHA-rich fish oil supplementation reduces glycogen synthase kinase (GSK-3), which is linked to both IR and AD. Baseline and post-intervention plasma samples from 58 adults with abdominal obesity (Age: 51.7 ± 1.7 years, BMI: 31.9 ± 0.8 kg/m 2 ) were analysed for outcome measures. Participants were allocated to 2 g DHA-rich fish oil capsules (860 mg DHA + 120 mg EPA) (n = 31) or placebo capsules (n = 27) per day for 12 weeks. Compared to placebo, DHA-rich fish oil significantly reduced GSK-3β by -2.3 ± 0.3 ng/mL. An inverse correlation ( p  < 0.05) was found between baseline insulin and IR and their changes following intervention only in participants with C-reactive protein levels higher than 2.4 mg/L. DHA-rich fish oil reduces GSK-3 and IR, suggesting a potential role of long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) in ameliorating AD risk.",2020,"Compared to placebo, DHA-rich fish oil significantly reduced GSK-3β by -2.3 ± 0.3 ng/mL.","['Overweight and Obese Midlife Adults', '58 adults with abdominal obesity (Age: 51.7 ± 1.7 years, BMI: 31.9 ± 0.8 kg/m 2 ']","['DHA-rich fish oil supplementation', 'DHA-rich fish oil capsules (860 mg DHA + 120 mg EPA', 'placebo capsules', 'placebo, DHA-rich fish oil', 'Docosahexaenoic Acid-Rich Fish Oil Supplementation']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",[],58.0,0.299726,"Compared to placebo, DHA-rich fish oil significantly reduced GSK-3β by -2.3 ± 0.3 ng/mL.","[{'ForeName': 'Rohith N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Jessica I', 'Initials': 'JI', 'LastName': 'Rosato', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Cintia B', 'Initials': 'CB', 'LastName': 'Dias', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Kylie A', 'Initials': 'KA', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Ralph N', 'Initials': 'RN', 'LastName': 'Martins', 'Affiliation': 'Department of Biomedical Sciences, Macquarie University, North Ryde NSW 2109, Australia.'}, {'ForeName': 'Manohar L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}]",Nutrients,['10.3390/nu12061612']
2002,32479786,"Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial.","BACKGROUND


The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium.
METHODS


In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1 mg and chlorpromazine at 12·5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov, NCT03021486.
FINDINGS


Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3 [-4·4 to -2·2]), and combination group (n=10, -3·0 [-4·6 to -1·4]), with no difference among groups (p=0·71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths.
INTERPRETATION


Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group.
FUNDING


National Institute of Nursing Research.",2020,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","['patients with terminal agitation', 'patients with cancer and delirium at an acute palliative care unit', 'Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14', 'patients with cancer with terminal delirium', 'patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose']","['neuroleptic strategies', 'Neuroleptic strategies', 'haloperidol', 'intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1\u2008mg and chlorpromazine']","['mean RASS score change', 'RASS score', 'Agitation Sedation Scale (RASS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087165', 'cui_str': 'Terminal agitation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",998.0,0.653147,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'De La Rosa', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Delgado-Guay', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Arthur', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Epner', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'De La Cruz', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heung', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimberson', 'Initials': 'K', 'LastName': 'Tanco', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of Investigational Pharmacy, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, Centre for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30307-7']
2003,32491233,Intrauterine versus external tocodynamometry in monitoring labour: a randomised controlled clinical trial.,"OBJECTIVE


To investigate whether the use of intrauterine tocodynamometry versus external tocodynamometry (IT versus ET) during labour reduces operative deliveries and improves newborn outcome. As IT provides more accurate information on labour contractions, the hypothesis was that it may more appropriately guide oxytocin use than ET.
DESIGN


Randomised controlled trial.
SETTING


Two labour wards, in a university tertiary hospital and a central hospital.
POPULATION


A total of 1504 parturients with singleton pregnancies, gestational age ≥37 weeks and fetus in cephalic position: 269 women with uterine scars, 889 nulliparas and 346 parous women with oxytocin augmentation.
METHODS


Participants underwent IT (n = 736) or ET (n = 768) during the active first stage of labour.
MAIN OUTCOME MEASURES


Primary outcome: rate of operative deliveries.
SECONDARY OUTCOMES


duration of labour, amount of oxytocin given, adverse neonatal outcomes.
RESULTS


Operative delivery rates were 26.9% (IT) and 25.9% (ET) (odds ratio 1.05, 95% CI 0.84-1.32, P = 0.663). The ET to IT conversion rate was 31%. We found no differences in secondary outcomes (IT versus ET). IT reduced oxytocin use during labours with signs of fetal distress, and trial of labour after caesarean section.
CONCLUSIONS


IT did not reduce the rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes, and it did not shorten labour duration.
TWEETABLE ABSTRACT


IT (versus ET) reduced oxytocin use in high-risk labours but did not influence operative delivery rate or adverse neonatal outcomes.",2020,"IT did not reduce the rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes, and it did not shorten labour duration.","['Two labour wards, in a university tertiary hospital and a central hospital', 'monitoring labour', '1504 parturients with singleton pregnancies, gestational age', '≥ 37 weeks and fetus in cephalic position', '269 women with uterine scars, 889 nulliparas and 346 parous women with oxytocin augmentation', 'Participants underwent IT (n=736) or ET (n=768) during the active first stage of labour']","['intrauterine vs. external tocodynamometry (IT vs. ET', 'Intrauterine versus external tocodynamometry']","['operative deliveries and improves newborn outcome', 'rate of operative deliveries', 'rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes', 'duration of labour, amount of oxytocin given, adverse neonatal outcomes', 'Operative delivery rates']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040345', 'cui_str': 'Tocodynamometry'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",269.0,0.239797,"IT did not reduce the rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes, and it did not shorten labour duration.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hautakangas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Central Hospital of Central Finland, Jyväskylä, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Uotila', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tampere University Hospital and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Palomäki', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tampere University Hospital and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16343']
2004,32484850,Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.,"BACKGROUND


Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention.
METHODS


We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life.
RESULTS


For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%).
CONCLUSIONS


In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.",2020,"In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.","['enrolling patients at six European medical centres', '1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n\u2009=\u2009772, mean number of daily medications\u2009=\u20099.34) or', 'hospitalized older patients with multi-morbidity and polypharmacy', 'older people during hospitalization']","['standard care alone (control, n\u2009=\u2009765, mean number of daily medications\u2009=\u20099.23) using block randomization stratified by site and admission type']","['occurrence of probable or certain ADRs', 'cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",1537.0,0.223776,"In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'University College Cork School of Medicine-Medicine Cork Ireland, Cork University Hospital Group, Cork, Ireland.'}, {'ForeName': 'Adalsteinn', 'Initials': 'A', 'LastName': 'Gudmundsson', 'Affiliation': 'Landspitali University Hospital Reykjavik, Landspitali, Iceland.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'NHS Grampian, University of Aberdeen Institute of Applied Health Sciences-Ageing Clinical and Experimental Research, Aberdeen, UK.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Petrovic', 'Affiliation': 'University of Ghent-Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Jose Cruz-Jentoft', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fordham', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Dahly', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gallagher', 'Affiliation': 'Cork University Hospital-Geriatric Medicine, Cork, Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lavan', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Curtin', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'University College Cork, National University of Ireland, Pharmaceutical Care Research Group, School of Pharmacy, Cork Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Cullinan', 'Affiliation': 'Royal College of Surgeons, School of Pharmacy, Dublin, Ireland.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Flanagan', 'Affiliation': 'University College Cork, Clinical Research Facility, Cork, Ireland.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'University College Cork, School of Epidemiology and Public Health, Cork, Ireland.'}, {'ForeName': 'Olafur', 'Initials': 'O', 'LastName': 'Samuelsson', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Astros', 'Initials': 'A', 'LastName': 'Sverrisdottir', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Selvarani', 'Initials': 'S', 'LastName': 'Subbarayan', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen UK.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Vandaele', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Meireson', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Montero-Errasquin', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Rexach-Cano', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Correa Perez', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Lozano-Montoya', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Vélez-Díaz-Pallarés', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Cerenzia', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Corradi', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Soledad Cotorruelo Ferreiro', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Dimitri', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marinelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Martelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Fong Soe Khioe', 'Affiliation': 'University of East Anglia, Faculty of Medicine and Health Sciences, Norwich, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eustace', 'Affiliation': 'University College Cork, National University of Ireland-Clinical Research Facility, Cork, Ireland.'}]",Age and ageing,['10.1093/ageing/afaa072']
2005,32484877,"Very-Low-Calorie Ketogenic Diets With Whey, Vegetable, or Animal Protein in Patients With Obesity: A Randomized Pilot Study.","CONTEXT


We compared the efficacy, safety, and effect of 45-day isocaloric very-low-calorie ketogenic diets (VLCKDs) incorporating whey, vegetable, or animal protein on the microbiota in patients with obesity and insulin resistance to test the hypothesis that protein source may modulate the response to VLCKD interventions.
SUBJECTS AND METHODS


Forty-eight patients with obesity (19 males and 29 females, homeostatic model assessment (HOMA) index ≥ 2.5, aged 56.2 ± 6.1 years, body mass index [BMI] 35.9 ± 4.1 kg/m2) were randomly assigned to three 45-day isocaloric VLCKD regimens (≤800 kcal/day) containing whey, plant, or animal protein. Anthropometric indexes; blood and urine chemistry, including parameters of kidney, liver, glucose, and lipid metabolism; body composition; muscle strength; and taxonomic composition of the gut microbiome were assessed. Adverse events were also recorded.
RESULTS


Body weight, BMI, blood pressure, waist circumference, HOMA index, insulin, and total and low-density lipoprotein cholesterol decreased in all patients. Patients who consumed whey protein had a more pronounced improvement in muscle strength. The markers of renal function worsened slightly in the animal protein group. A decrease in the relative abundance of Firmicutes and an increase in Bacteroidetes were observed after the consumption of VLCKDs. This pattern was less pronounced in patients consuming animal protein.
CONCLUSIONS


VLCKDs led to significant weight loss and a striking improvement in metabolic parameters over a 45-day period. VLCKDs based on whey or vegetable protein have a safer profile and result in a healthier microbiota composition than those containing animal proteins. VLCKDs incorporating whey protein are more effective in maintaining muscle performance.",2020,A decrease in the relative abundance of Firmicutes and an increase in Bacteroidetes were observed after the consumption of VLCKDs.,"['Forty-eight patients with obesity [19 males and 29 females, HOMA index ≥ 2.5, age', '56.2±6.1 years, body mass index (BMI) 35.9±4.1 kg/m2', 'patients with obesity and insulin resistance', 'Patients with Obesity']","['VLCKDs based on whey or vegetable protein', 'Whey, Vegetable or Animal Protein', '45-day isocaloric very-low-calorie ketogenic diets (VLCKDs) incorporating whey, vegetable or animal protein', '45-day isocaloric VLCKD regimens (≤800 kcal/day) containing whey, plant or animal protein']","['renal function', 'muscle strength', 'Adverse events', 'Body weight, BMI, blood pressure, waist circumference, HOMA index, insulin, and total and LDL cholesterol', 'weight loss', 'Anthropometric indexes; blood and urine chemistry, including parameters of kidney, liver, glucose and lipid metabolism; body composition; muscle strength; and taxonomic composition of the gut microbiome', 'metabolic parameters', 'relative abundance of Firmicutes and an increase in Bacteroidetes']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0042439', 'cui_str': 'Dietary Plant Proteins'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0440447', 'cui_str': 'Animal protein'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",48.0,0.0192069,A decrease in the relative abundance of Firmicutes and an increase in Bacteroidetes were observed after the consumption of VLCKDs.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Basciani', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Camajani', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Savina', 'Initials': 'S', 'LastName': 'Contini', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Persichetti', 'Affiliation': 'Service of Pharmacovigilance, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Risi', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Bertoldi', 'Affiliation': 'BMR Genomics s.r.l., Padova, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Strigari', 'Affiliation': 'Department of Medical Physics, Policlinico S. Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Prossomariti', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Mikiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Mariani', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Lubrano', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Genco', 'Affiliation': 'Department of Surgical Sciences, Surgical Endoscopy Unit, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Spera', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Gnessi', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza,"" Rome, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa336']
2006,32583295,Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.,"BACKGROUND AND OBJECTIVE


Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine.
METHODS


Patients requiring analgesia after bunionectomy or abdominoplasty were randomized to IV demand doses of placebo, oliceridine (0.1 mg, 0.35 mg, or 0.5 mg), or morphine (1 mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5 mg, morphine 4 mg, volume-matched placebo) with a 6-min lockout interval. Certified nurse anesthetists monitored each patient and withheld study medication according to the patient's respiratory status. For each patient, the duration of all DIs was summed and reported as CDDI. A zero-inflated gamma mixture model was used to compute the mean CDDI for each treatment.
RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%). The CDDI was also lower across all demand doses of oliceridine versus morphine.
CONCLUSION


Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.",2020,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","['Patients requiring analgesia after bunionectomy or abdominoplasty', 'Patients Treated for Acute Postoperative Pain']","['Oliceridine and Morphine', 'oliceridine', 'placebo, oliceridine', 'morphine (1\xa0mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5\xa0mg, morphine 4\xa0mg, volume-matched placebo', 'oliceridine and morphine', 'Oliceridine', 'morphine']","['respiratory safety', 'average cumulative duration of DI (CDDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.0289906,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","[{'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesiology, Cleveland Clinic, Outcomes Research, Anesthesiology Institute, Fairview Hospital, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. Saayad@ccf.org.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burt', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Clinical drug investigation,['10.1007/s40261-020-00936-0']
2007,32585354,The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.,"BACKGROUND


Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies.
OBJECTIVE


To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received.
METHODS


Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT.
RESULTS


Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT.
CONCLUSIONS


In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016']
2008,32585438,Effect of in-bed cycling on acute muscle wasting in critically ill adults: A randomised clinical trial.,"PURPOSE


To examine whether in-bed cycling assists critically ill adults to reduce acute muscle wasting, improve function and improve quality of life following a period of critical illness.
MATERIALS AND METHODS


A single-centre, two-group, randomised controlled trial with blinded assessment of the primary outcome was conducted in a tertiary ICU. Critically ill patients expected to be mechanically ventilated for at least 48 h were randomised to 30 min daily in-bed cycling in addition to usual-care physiotherapy (n = 37) or usual-care physiotherapy (n = 37). The primary outcome was muscle atrophy of rectus femoris cross-sectional area (RF CSA ) measured by ultrasound at Day 10 following study enrolment. Secondary outcomes included manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission.
RESULTS


Analysis included the 72 participants (mean age, 56-years; male, 68%) who completed the study. There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
CONCLUSIONS AND RELEVANCE


In-bed cycling did not reduce muscle wasting in critically ill adults, but this study provides useful effect estimates for large-scale clinical trials.
TRIAL REGISTRATION


anzctr.org.au Identifier: ACTRN12616000948493.",2020,"There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
","['72 participants (mean age, 56-years; male, 68%) who completed the study', 'critically ill adults', 'Critically ill patients expected to be mechanically ventilated for at least 48\xa0h']","['anzctr.org.au Identifier', '30\xa0min daily in-bed cycling in addition to usual-care physiotherapy (n\xa0=\xa037) or usual-care physiotherapy', 'bed cycling']","['quality of life', 'manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission', 'muscle atrophy of rectus femoris cross-sectional area (RF CSA ', 'muscle atrophy of RF CSA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}]",,0.450536,"There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
","[{'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Nickels', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: marc.nickels@health.qld.gov.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Health Sciences, City, University of London, London, United Kingdom; Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. Electronic address: leanne.aitken.1@city.ac.uk.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: a.barnett@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: james.walsham@health.qld.gov.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: scott.king@health.qld.gov.au.'}, {'ForeName': 'Nicolette E', 'Initials': 'NE', 'LastName': 'Gale', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: nicolette.gale@health.qld.gov.au.'}, {'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Bowen', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: alicia.bowen@health.qld.gov.au.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Peel', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: brent.peel@health.qld.gov.au.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Donaldson', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: samuel.donaldson2@health.qld.gov.au.'}, {'ForeName': 'Stewart T J', 'Initials': 'STJ', 'LastName': 'Mealing', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: stewart.mealing@health.qld.gov.au.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Clinical Informatics, Metro South Health, Brisbane, Australia. Electronic address: steven.mcphail@qut.edu.au.'}]",Journal of critical care,['10.1016/j.jcrc.2020.05.008']
2009,32587084,Improving surgical antibiotic prophylaxis adherence and reducing hospital readmissions: a bundle of interventions including health information technologies.,"OBJECTIVES


Infection following orthopaedic surgery is a feared complication and an indicator of the quality of the hospital. Surgical antibiotic prophylaxis (SAP) guidelines are not always properly followed. Our aim was to describe and evaluate the impact of a multidisciplinary intervention on antibiotic prophylaxis adherence to hospital guidelines and 30-day postoperative outcomes.
METHODS


The study was carried out from January to May 2016 and consisted of creating a multidisciplinary team, updating institutional guidelines and embedding the recommendations in the computerised physician order entry system which is linked to dose and renal function alerts, educational activities and pharmaceutical bedside care of patients in the orthopaedic department. A prospective pre-post study was carried out in accordance with the Declaration of Helsinki. The following information was recorded: patient and surgery characteristics, adherence to SAP guidelines, surgical site infections, length of hospital stay and rate of readmission 30 days after discharge. Statistical analyses were performed using SPSS 18.0.
RESULTS


Eighty three orthopaedic patients of mean±SD age 68.2±17.0 years (44.6% male, 40 in the pre-intervention group and 43 in the intervention group) were included. Cefazolin was the recommended and most commonly administered antibiotic agent. In the intervention group, an improvement in global adherence to guidelines was achieved (76.7% vs 89.9%; p=0.039): antibiotic duration (75.0% vs 97.7%), correct dosage post-surgery (55.0% vs 76.7%), timing of administration (57.5% vs 72.1%), antibiotic pre-surgery prescription (92.5% vs 97.7%). Three surgical site infections were detected in the pre-intervention group and none in the intervention group (p>0.05). Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038).
CONCLUSIONS


SAP is used in daily practice in most orthopaedic patients. The implementation of a multidisciplinary programme based on health technology improved the adherence to guidelines and appeared to reduce the readmission rate.",2020,"Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038).
","['68.2±17.0\u2009years (44.6% male, 40 in the pre-intervention group and 43 in the intervention group) were included', 'most orthopaedic patients', 'Eighty', 'three orthopaedic patients of mean±SD age']","['multidisciplinary intervention', 'Surgical antibiotic prophylaxis (SAP', 'Cefazolin']","['readmission', 'patient and surgery characteristics, adherence to SAP guidelines, surgical site infections, length of hospital stay and rate of readmission 30\u2009days after discharge', 'readmission rate', 'Length of hospital stay', 'correct dosage post-surgery', 'global adherence to guidelines', 'antibiotic duration', 'hospital readmissions', 'antibiotic pre-surgery prescription', 'surgical site infections']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",83.0,0.0866826,"Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038).
","[{'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Ribed', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Monje', 'Affiliation': 'Pharmacy Department Hospital, Universitario Del Henares, Coslada, Spain.'}, {'ForeName': 'Xandra', 'Initials': 'X', 'LastName': 'García-González', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Sanchez-Somolinos', 'Affiliation': 'Microbiology and Infectious Diseases Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Sanz-Ruiz', 'Affiliation': 'Orthopaedic Surgery Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Carmen Guadalupe', 'Initials': 'CG', 'LastName': 'Rodríguez-González', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Sanjurjo-Saez', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}]",European journal of hospital pharmacy : science and practice,['10.1136/ejhpharm-2018-001666']
2010,32589146,Statistical Issues and Lessons Learned From COVID-19 Clinical Trials With Lopinavir-Ritonavir and Remdesivir.,"BACKGROUND


Recently, three randomized clinical trials on coronavirus disease (COVID-19) treatments were completed: one for lopinavir-ritonavir and two for remdesivir. One trial reported that remdesivir was superior to placebo in shortening the time to recovery, while the other two showed no benefit of the treatment under investigation.
OBJECTIVE


The aim of this paper is to, from a statistical perspective, identify several key issues in the design and analysis of three COVID-19 trials and reanalyze the data from the cumulative incidence curves in the three trials using more appropriate statistical methods.
METHODS


The lopinavir-ritonavir trial enrolled 39 additional patients due to insignificant results after the sample size reached the planned number, which led to inflation of the type I error rate. The remdesivir trial of Wang et al failed to reach the planned sample size due to a lack of eligible patients, and the bootstrap method was used to predict the quantity of clinical interest conditionally and unconditionally if the trial had continued to reach the originally planned sample size. Moreover, we used a terminal (or cure) rate model and a model-free metric known as the restricted mean survival time or the restricted mean time to improvement (RMTI) to analyze the reconstructed data. The remdesivir trial of Beigel et al reported the median recovery time of the remdesivir and placebo groups, and the rate ratio for recovery, while both quantities depend on a particular time point representing local information. We use the restricted mean time to recovery (RMTR) as a global and robust measure for efficacy.
RESULTS


For the lopinavir-ritonavir trial, with the increase of sample size from 160 to 199, the type I error rate was inflated from 0.05 to 0.071. The difference of RMTIs between the two groups evaluated at day 28 was -1.67 days (95% CI -3.62 to 0.28; P=.09) in favor of lopinavir-ritonavir but not statistically significant. For the remdesivir trial of Wang et al, the difference of RMTIs at day 28 was -0.89 days (95% CI -2.84 to 1.06; P=.37). The planned sample size was 453, yet only 236 patients were enrolled. The conditional prediction shows that the hazard ratio estimates would reach statistical significance if the target sample size had been maintained. For the remdesivir trial of Beigel et al, the difference of RMTRs between the remdesivir and placebo groups at day 30 was -2.7 days (95% CI -4.0 to -1.2; P<.001), confirming the superiority of remdesivir. The difference in the recovery time at the 25th percentile (95% CI -3 to 0; P=.65) was insignificant, while the differences became more statistically significant at larger percentiles.
CONCLUSIONS


Based on the statistical issues and lessons learned from the recent three clinical trials on COVID-19 treatments, we suggest more appropriate approaches for the design and analysis of ongoing and future COVID-19 trials.",2020,"The difference of RMTIs between the two groups evaluated at day 28 was -1.67 days (95% CI [-3.62, 0.28]; P=.09) in favor of lopinavir-ritonavir but not statistically significant.",['236 patients were enrolled'],"['lopinavir-ritonavir', 'Lopinavir-Ritonavir and Remdesivir', 'placebo']","['mean survival time', 'rate ratio for recovery', 'recovery time', 'RMTIs', 'median recovery time', 'mean time to recovery (RMTR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",39.0,0.188497,"The difference of RMTIs between the two groups evaluated at day 28 was -1.67 days (95% CI [-3.62, 0.28]; P=.09) in favor of lopinavir-ritonavir but not statistically significant.","[{'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Yin', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Hong Kong, China (Hong Kong).'}]",JMIR public health and surveillance,['10.2196/19538']
2011,32591295,Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial.,"INTRODUCTION AND OBJECTIVES


Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists.
METHODS


ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months.
RESULTS


The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01.
CONCLUSIONS


ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.",2020,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","['320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to', 'HF patients with reduced left ventricular ejection fraction']","['angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB', 'HF nurse titration vs 156 to HF cardiologist titration']","['mortality and heart failure (HF) hospitalizations', 'safety and efficacy', 'adverse events', 'ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months', 'mean±standard deviation visits', 'beta-blocker mean relative dose']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",320.0,0.116585,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","[{'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Oyanguren', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain; BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain. Electronic address: juanaoy@hotmail.com.'}, {'ForeName': 'Lluisa', 'Initials': 'L', 'LastName': 'Garcia-Garrido', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Nebot-Margalef', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Latorre-García', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Torcal-Laguna', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Roure', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Costello', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Manito', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'García-Pinilla', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sánchez-Paule', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Varela-Román', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Moure', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Segovia-Cubero', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Soria', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Eunate', 'Initials': 'E', 'LastName': 'Arana-Arri', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Lekuona', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.04.016']
2012,32593228,Development and evaluation of e-learning materials for dental hygiene students in six schools: Using smartphones to learn dental treatment procedures.,"OBJECTIVE


The purpose of this study was to develop and evaluate the effectiveness of using e-learning on smartphones to provide dental hygiene education on dental treatment procedures.
METHODS


This was a randomized controlled trial. Two-hundred ninety-three dental hygiene students in four universities, one junior college and one technical school took a preliminary examination, and based on the results, participants in each school were randomly divided into two groups, a test or control group. Both groups took pre- and post-examinations at a 4-week interval. The test groups learned dental treatment procedures and four-handed techniques with interactive learning materials using smartphones. The learning materials allowed them to watch videos of dental treatments. The control groups were not provided any learning material.
RESULTS


Results of all schools combined showed that the changes from pre- to post-examination scores in the test groups were significantly higher than those of the control groups (p < .05). Post-examination scores were significantly higher than pre-examination scores in the test groups in all schools (p  < .05). Also, post-examination scores of the test groups were significantly higher than those of the control groups (p < .05). The changes from pre- to post-examination scores in the test groups of two schools were significantly higher than those of control groups (p < .05). Post-examination scores of the control groups in two schools were significantly higher than pre-examination scores (p < .05).
CONCLUSIONS


Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.",2020,"CONCLUSIONS


Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.","['Two-hundred ninety-three dental hygiene students in four universities, one junior college, and one technical school took a preliminary examination, and based on the results, participants in each school', 'dental hygiene students in six schools']","['e-learning', 'learned dental treatment procedures and four-handed techniques with interactive learning materials using smartphones']","['pre- to post-examination scores', 'Post-examination scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0815244', 'cui_str': 'Interactive Learning'}, {'cui': 'C0449902', 'cui_str': 'Material used'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",293.0,0.0139299,"CONCLUSIONS


Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takenouchi', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Etsuyo', 'Initials': 'E', 'LastName': 'Otani', 'Affiliation': 'Shinjuku Medical Career College, Tokyo, Japan.'}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Sunaga', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Department of Oral Health Sciences, Faculty of Health Sciences, Osaka Dental University, Osaka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Uehara', 'Affiliation': 'Department of Oral Health, Kobe Tokiwa Junior College, Hyogo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Akiyama', 'Affiliation': 'Department of Health Sciences, School of Health and Social Services, Saitama Prefectural University, Saitama, Japan.'}, {'ForeName': 'Takae', 'Initials': 'T', 'LastName': 'Kawashima', 'Affiliation': 'Shinjuku Medical Career College, Tokyo, Japan.'}, {'ForeName': 'Kanade', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Oral Care for Systemic Health Support, Health Sciences and Biomedical Engineering, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Izuno', 'Affiliation': ""Department of Oral Health Sciences, Faculty of Nursing and Health Care, BAIKA Women's University, Osaka, Japan.""}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12452']
2013,32598941,Unskilled shooters improve both accuracy and grouping shot having as reference skilled shooters cortical area: An EEG and tDCS study.,"Transcranial direct current stimulation (tDCS) has been used as a non-invasive method for enhanced motor and cognitive abilities. However, no previous study has investigated if the tDCS application in unskilled shooters on cortical sites, selected based on the cortical activity of skilled shooters, improves the accuracy and shot grouping. Sixty participants were selected, which included 10 skilled shooters and 50 unskilled shooters. After we identified the right dorsolateral prefrontal cortex (DLPFC) as the area with the highest activity in skilled shooters, we applied anodal tDCS over the right DLPFC in the unskilled shooters under two conditions: sham-tDCS (placebo) and real-tDCS (anodal tDCS). We also analyzed electroencephalography. Our results indicated that anodal tDCS application enhanced the shot accuracy (p = 0.001). Furthermore, the beta power in the EEG recording was higher in the left DLPFC, left and right parietal cortex (p = 0,001) after applying anodal tDCS, while the low-gamma power was higher in the right DLPFC in sham-tDCS (p = 0.001) and right parietal cortex after anodal-tDCS (p = 0.001). Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC. Furthermore, beta and low-gamma bands are influenced by anodal tDCS over the right DLPFC, which may be predictive of skill improvement.",2020,Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC.,"['Sixty participants were selected, which included 10 skilled shooters and 50 unskilled shooters']","['tDCS (placebo) and real-tDCS (anodal tDCS', 'Transcranial direct current stimulation (tDCS', 'anodal tDCS']",['beta power in the EEG recording'],"[{'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",60.0,0.0141525,Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC.,"[{'ForeName': 'Kaline', 'Initials': 'K', 'LastName': 'Rocha', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil. Electronic address: kalinemrocha@gmail.com.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Magalhães', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Valécia', 'Initials': 'V', 'LastName': 'Carvalho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Thayaná', 'Initials': 'T', 'LastName': 'Fernandes', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Crespo', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Velasques', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ribeiro', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Biomedical Engineering Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil; Brain Mapping and Functionality Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Daya S', 'Initials': 'DS', 'LastName': 'Gupta', 'Affiliation': 'Department of Biology, Camden County College, Blackwood, NJ, United States.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113036']
2014,32599738,Are Sugar-Reduced and Whole Grain Infant Cereals Sensorially Accepted at Weaning? A Randomized Controlled Cross-Over Trial.,"The way infants are fed during the complementary period can have a significant impact on infants' health and development. Infant cereals play an important role in complementary feeding in many countries. In spite of well documented benefits of a low sugar and high whole grain diet, commercial infant cereals are often refined and contain a high amount of sugars. The aim of the present study was to compare the sensory acceptability, gastrointestinal tolerance and bowel habits of two commercially available infant cereals in Spain with varying sugar and whole grain contents in infants at weaning. Forty-six healthy infants (mean age = 5.2 ± 0.4 months) received one of the two infant cereals containing either 0% whole grain flour and a high sugar content produced by starch hydrolysis (24 g/100 g) (Cereal A) or 50% whole grain flour and a medium-sugar content produced by hydrolysis (12 g/100 g) (Cereal B) in a randomized, triple blind, cross-over controlled trial. Both types of infant cereals were consumed for seven weeks. The cross-over was carried out after seven weeks. Sensory acceptability, anthropometry, gastrointestinal tolerance and adverse events were measured, and results evaluated using a linear regression model. No significant differences were observed between groups in any of the main variables analyzed. Importantly, the long-term health implications of our findings represent a wake-up call for the food industry to reduce or even eliminate simple sugars in infant cereals and for regulatory bodies and professional organizations to recommend whole grain infant cereals.",2020,No significant differences were observed between groups in any of the main variables analyzed.,"['Spain with varying sugar and whole grain contents in infants at weaning', 'Forty-six healthy infants (mean age = 5.2 ± 0.4 months']",['infant cereals containing either 0% whole grain flour and a high sugar content produced by starch hydrolysis (24 g/100 g) (Cereal A) or 50% whole grain flour and a medium-sugar content produced by hydrolysis'],"['Sensory acceptability, anthropometry, gastrointestinal tolerance and adverse events', 'sensory acceptability, gastrointestinal tolerance and bowel habits']","[{'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0020291', 'cui_str': 'Hydrolysis'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",46.0,0.100743,No significant differences were observed between groups in any of the main variables analyzed.,"[{'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Sanchez-Siles', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Bernal', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gil', 'Affiliation': 'Pediatric Gastroenterology, Hepatology and Nutrition Unit, Hospital Clínico Universitario Virgen de la Arrixaca, 30120 Murcia, Spain.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bodenstab', 'Affiliation': 'Institute for Research and Nutrition, Hero Group, 5600 Lenzburg, Switzerland.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Haro-Vicente', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Klerks', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Plaza-Diaz', 'Affiliation': 'Institute of Nutrition and Food Technology ""José Mataix"", Center of Biomedical Research, University of Granada, Avda. del Conocimiento s/n., 18016 Armilla, Granada, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil', 'Affiliation': 'Institute of Nutrition and Food Technology ""José Mataix"", Center of Biomedical Research, University of Granada, Avda. del Conocimiento s/n., 18016 Armilla, Granada, Spain.'}]",Nutrients,['10.3390/nu12061883']
2015,32599767,"Efficacy of an Internet-Based Program to Promote Physical Activity and Exercise after Inpatient Rehabilitation in Persons with Multiple Sclerosis: A Randomized, Single-Blind, Controlled Study.","BACKGROUND


Multimodal rehabilitation improves fatigue and mobility in persons with multiple sclerosis (PwMS). Effects are transient and may be conserved by internet-based physical activity promotion programs.
OBJECTIVE


Evaluate the effects of internet-based physical activity and exercise promotion on fatigue, quality of life, and gait in PwMS after inpatient rehabilitation.
METHODS


PwMS (Expanded Disability Status Scale (EDSS) ≤ 6.0, fatigue: Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32) were randomized into an intervention group (IG) or a control group (CG). After rehabilitation, IG received 3 months of internet-based physical activity promotion, while CG received no intervention.
PRIMARY OUTCOME


self-reported fatigue (WEIMuS).
SECONDARY OUTCOMES


quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score).
MEASUREMENTS


beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards.
RESULTS


64 of 84 PwMS were analyzed (IG: 34, CG: 30). After rehabilitation, fatigue decreased in both groups. At T2 and T3, fatigue increased again in CG but was improved in IG ( p  < 0.001). MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG. Gait improvements were more pronounced in IG at T2.
CONCLUSIONS


The study provides Class II evidence that the effects of rehabilitation on fatigue, quality of life, and gait can be maintained for 3-6 months with an internet-based physical activity and exercise promotion program.",2020,MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG.,"['Persons with Multiple Sclerosis', '≤ 6.0, fatigue: Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32', 'persons with multiple sclerosis (PwMS', '64 of 84 PwMS were analyzed']","['internet-based physical activity promotion, while CG received no intervention', 'Internet-Based Program to Promote Physical Activity and Exercise', 'internet-based physical activity and exercise promotion', 'intervention group (IG) or a control group (CG', 'Multimodal rehabilitation']","['Gait improvements', 'MSIS-29', 'quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score', 'fatigue', 'fatigue, quality of life, and gait', 'beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards', 'self-reported fatigue (WEIMuS', 'PwMS (Expanded Disability Status Scale (EDSS', 'fatigue and mobility', 'fatigue, quality of life, and gait in PwMS', 'fatigue increased again in CG']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0582434', 'cui_str': 'Giving encouragement to exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",84.0,0.027244,MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flachenecker', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Anna Karoline', 'Initials': 'AK', 'LastName': 'Bures', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Angeli', 'Initials': 'A', 'LastName': 'Gawlik', 'Affiliation': 'Department of Health & Social Psychology, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Weiland', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kuld', 'Affiliation': 'Faculty of Economics, University of Bayreuth, 95447 Bayreuth, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gusowski', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Streber', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tallner', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17124544']
2016,32599773,Randomized Double-Blind Controlled Trial on the Effect of Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios on Sleep in Adolescents: The PROTMORPHEUS Study.,"Disturbed sleep is common in adolescents. Ingested nutrients help regulate the internal clock and influence sleep quality. The purpose of this clinical trial is to assess the effect of protein tryptophan (Trp)/large neutral amino acids (LNAAs) ratio on sleep and circadian rhythm. Ingested Trp is involved in the regulation of the sleep/wake cycle and improvement of sleep quality. Since Trp transport through the blood-brain barrier is competing with LNAAs, protein with higher Trp/LNAAs were expected to increase sleep efficiency. This randomized double-blind controlled trial will enroll two samples of male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24). They will take part randomly in three sessions each held over a week. They will undergo a washout period, when dietary intake will be calibrated (three days), followed by an intervention period (three days), when their diet will be supplemented with three proteins with different Trp/LNAAs ratios. Physical, cognitive, dietary intake, appetite, and sleepiness evaluations will be made on the last day of each session. The primary outcome is sleep efficiency measured through in-home electroencephalogram recordings. Secondary outcomes include sleep staging, circadian phase, and sleep-, food intake-, metabolism-, and inflammation-related biochemical markers. A fuller understanding of the effect of protein Trp/LNAAs ratio on sleep could help in developing nutritional strategies addressing sleep disturbances.",2020,This randomized double-blind controlled trial will enroll two samples of male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24).,"['Adolescents', 'male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24']","['protein tryptophan (Trp)/large neutral amino acids (LNAAs) ratio', 'protein Trp/LNAAs ratio', 'Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios']","['Physical, cognitive, dietary intake, appetite, and sleepiness evaluations', 'sleep efficiency measured through in-home electroencephalogram recordings', 'Disturbed sleep', 'internal clock and influence sleep quality', 'sleep staging, circadian phase, and sleep-, food intake-, metabolism-, and inflammation-related biochemical markers', 'sleep efficiency']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0301715', 'cui_str': 'Neutral amino acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}]",24.0,0.212532,This randomized double-blind controlled trial will enroll two samples of male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24).,"[{'ForeName': 'Oussama', 'Initials': 'O', 'LastName': 'Saidi', 'Affiliation': 'Clermont Auvergne University, Laboratory of Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Rochette', 'Affiliation': 'Department of Pediatrics, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doré', 'Affiliation': 'Clermont Auvergne University, Laboratory of Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Maso', 'Affiliation': 'Rugby Training Center of the Sportive Association Montferrandaise, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Raoux', 'Affiliation': 'OXSITIS LAB-NUTRITION, Chrono-Nutrition Food Supplements, 63110 Clermont-Ferrand, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Andrieux', 'Affiliation': 'OXSITIS LAB-NUTRITION, Chrono-Nutrition Food Supplements, 63110 Clermont-Ferrand, France.'}, {'ForeName': 'Maria Livia', 'Initials': 'ML', 'LastName': 'Fantini', 'Affiliation': 'Neurophysiology Unit, Neurology Department, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Merlin', 'Affiliation': 'Department of Pediatrics, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics Unit (DRCI), Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Walrand', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand University Hospital, INRAE, UNH, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duché', 'Affiliation': 'Toulon University, Laboratory of the Impact of Physical Activity on Health (IAPS), 83000 Toulon, France.'}]",Nutrients,['10.3390/nu12061885']
2017,32599792,Recommendations for Implementing Lung Cancer Screening with Low-Dose Computed Tomography in Europe.,"Lung cancer screening (LCS) with low-dose computed tomography (LDCT) was demonstrated in the National Lung Screening Trial (NLST) to reduce mortality from the disease. European mortality data has recently become available from the Nelson randomised controlled trial, which confirmed lung cancer mortality reductions by 26% in men and 39-61% in women. Recent studies in Europe and the USA also showed positive results in screening workers exposed to asbestos. All European experts attending the ""Initiative for European Lung Screening (IELS)""-a large international group of physicians and other experts concerned with lung cancer-agreed that LDCT-LCS should be implemented in Europe. However, the economic impact of LDCT-LCS and guidelines for its effective and safe implementation still need to be formulated. To this purpose, the IELS was asked to prepare recommendations to implement LCS and examine outstanding issues. A subgroup carried out a comprehensive literature review on LDCT-LCS and presented findings at a meeting held in Milan in November 2018. The present recommendations reflect that consensus was reached.",2020,"All European experts attending the ""Initiative for European Lung Screening (IELS)""-a large international group of physicians and other experts concerned with lung cancer-agreed that LDCT-LCS should be implemented in Europe.",['Implementing Lung Cancer Screening with Low-Dose Computed Tomography in Europe'],"['Lung cancer screening (LCS) with low-dose computed tomography (LDCT', 'IELS']",['lung cancer mortality reductions'],"[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0765974,"All European experts attending the ""Initiative for European Lung Screening (IELS)""-a large international group of physicians and other experts concerned with lung cancer-agreed that LDCT-LCS should be implemented in Europe.","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Veronesi', 'Affiliation': 'Faculty of Medicine and Surgery-Vita-Salute San Raffaele University, 20132 Milan, Italy.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Department of Respiratory Medicine, David Evans Research Centre, Nottingham University Hospitals NHS Trust, Nottingham NG5 1PB, UK.'}, {'ForeName': 'Claudia I', 'Initials': 'CI', 'LastName': 'Henschke', 'Affiliation': 'Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ghislandi', 'Affiliation': 'Department of Social and Political Sciences, Bocconi University, 20136 Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Iavicoli', 'Affiliation': ""Department of Occupational and Environmental Medicine, Epidemiology and Hygiene, Italian Workers' Compensation Authority (INAIL), 00078 Rome, Italy.""}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Center for Medical Imaging, University Medical Center Groningen, University of Groningen, 9712 CP Groningen, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Department of Public Health, Erasmus MC-University Medical Centre Rotterdam, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shemesh', 'Affiliation': 'The Grace Ballas Cardiac Research Unit, Sheba Medical Center, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, 52621 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Field', 'Affiliation': 'Roy Castle Lung Cancer Research Programme, Department of Molecular and Clinical Cancer Medicine, The University of Liverpool, Liverpool L69 3BX, UK.'}, {'ForeName': 'Javier J', 'Initials': 'JJ', 'LastName': 'Zulueta', 'Affiliation': 'Department of Pulmonology, Clinica Universidad de Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Horgan', 'Affiliation': ""European Alliance for Personalised Medicine (EAPM), Avenue de l'Armée Legerlaan 10, 1040 Brussels, Belgium.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Fiestas Navarrete', 'Affiliation': 'Department of Social and Political Sciences, Bocconi University, 20136 Milan, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Valentino Infante', 'Affiliation': 'Thoracic Surgery Department, University and Hospital Trust-Ospedale Borgo Trento, 37126 Verona, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Novellis', 'Affiliation': 'Division of Thoracic Surgery, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'Division of Epidemiology and Public Health, UK Centre for Tobacco and Alcohol Studies, Clinical Sciences Building, City Hospital, University of Nottingham, Nottingham NG5 1PB, UK.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Peled', 'Affiliation': 'The Legacy Heritage Oncology Center & Dr. Larry Norton Institute, Soroka Medical Center & Ben-Gurion University, 84101 Beer-Sheva, Israel.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Rampinelli', 'Affiliation': 'Department of Medical Imaging and Radiation Sciences, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Rocco', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Rzyman', 'Affiliation': 'Department of Thoracic Surgery, Medical University of Gdańsk, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Giorgio Vittorio', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology, University of Torino, 10124 Torino, Italy.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Tammemagi', 'Affiliation': 'Department of Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bertolaccini', 'Affiliation': 'Division of Thoracic Surgery, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Natthaya', 'Initials': 'N', 'LastName': 'Triphuridet', 'Affiliation': 'Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Yip', 'Affiliation': 'Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, 20090 Pieve Emanuele (MI), Italy.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Centers, VU location, De Boelelaan 1117, Postbox 7057, 1007 MB Amsterdam, The Netherlands.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ferrante', 'Affiliation': 'Department of Cardiovascular Medicine, Humanitas Clinical and Research Center IRCCS, 20089 Rozzano (MI), Italy.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brain', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff CF14 4YS, UK.'}, {'ForeName': 'Carlijn', 'Initials': 'C', 'LastName': 'van der Aalst', 'Affiliation': 'Department of Public Health, Erasmus MC-University Medical Centre Rotterdam, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Bonomo', 'Affiliation': 'Department of Bioimaging and Radiological Sciences, Catholic University, 00168 Rome, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ""Epidemiology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.""}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Van Meerbeeck', 'Affiliation': 'Thoracic Oncology, Antwerp University Hospital and Ghent University, 2650 Edegem, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Maisonneuve', 'Affiliation': 'Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Torino, 10124 Torino, Italy.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Department of Radiology, Royal Brompton Hospital, London SW3 6NP, UK.'}, {'ForeName': 'Zaigham', 'Initials': 'Z', 'LastName': 'Saghir', 'Affiliation': 'Department of Respiratory Medicine, Herlev-Gentofte University Hospital, 2900 Hellerup, Denmark.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pelosi', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy.'}]",Cancers,['10.3390/cancers12061672']
2018,32606267,Comparison of treatment outcomes in lumbar central stenosis patients treated with epidural steroid injections: interlaminar  versus  bilateral transforaminal approach.,"Background


We aimed to compare interlaminar epidural steroid injections (ILESI) and bilateral transforaminal epidural steroid injections (TFESI) on pain intensity, functional status, depression, walking distance, and the neuropathic component in patients with lumbar central spinal stenosis (LCSS).
Methods


The patients were divided into either the ILESI or the bilateral TFESI groups. Prime outcome measures include the numerical rating scale (NRS), Oswestry disability index (ODI), Beck depression inventory (BDI), and pain-free walking distance. The douleur neuropathique en 4 questions score was used as a secondary outcome measure.
Results


A total of 72 patients were finally included. NRS, ODI, and BDI scores showed a significant decline in both groups in all follow-ups. Third-month NRS scores were significantly lower in the ILESI group ( P  = 0.047). The percentages of decrease in the ODI and BDI scores between the baseline and the third week and third month were significantly higher in the ILESI group ( P  = 0.017,  P  = 0.001 and  P  = 0.048,  P  = 0.030, respectively). Pain-free walking distance percentages from the baseline to the third week and third month were significantly higher in the ILESI group ( P  = 0.036,  P  < 0.001). The proportion of patients with neuropathic pain in the bilateral TFESI group significantly decreased in the third week compared to the baseline ( P  = 0.020).
Conclusions


Both ILESI and TFESI are reliable treatment options for LCSS. ILESI might be preferred because of easier application and more effectiveness. However, TFESI might be a better option in patients with more prominent neuropathic pain.",2020,"Pain-free walking distance percentages from the baseline to the third week and third month were significantly higher in the ILESI group ( P  = 0.036,  P  < 0.001).","['lumbar central stenosis patients treated with', 'A total of 72 patients were finally included', 'patients with lumbar central spinal stenosis (LCSS', 'patients with more prominent neuropathic pain']","['ILESI', 'interlaminar epidural steroid injections (ILESI) and bilateral transforaminal epidural steroid injections (TFESI', 'epidural steroid injections: interlaminar  versus  bilateral transforaminal approach', 'TFESI', 'ILESI and TFESI']","['Pain-free walking distance percentages', 'proportion of patients with neuropathic pain', 'pain intensity, functional status, depression, walking distance, and the neuropathic component', 'ODI and BDI scores', 'NRS, ODI, and BDI scores', 'numerical rating scale (NRS), Oswestry disability index (ODI), Beck depression inventory (BDI), and pain-free walking distance']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037944', 'cui_str': 'Spinal stenosis'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]","[{'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1562084', 'cui_str': 'Transforaminal approach'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",72.0,0.0309453,"Pain-free walking distance percentages from the baseline to the third week and third month were significantly higher in the ILESI group ( P  = 0.036,  P  < 0.001).","[{'ForeName': 'Savas', 'Initials': 'S', 'LastName': 'Sencan', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Ipek Saadet', 'Initials': 'IS', 'LastName': 'Edipoglu', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Alp Eren', 'Initials': 'AE', 'LastName': 'Celenlioglu', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Yolcu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Osman Hakan', 'Initials': 'OH', 'LastName': 'Gunduz', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.226']
2019,32606270,"Comparing the effectiveness of ultrasound guided  versus  blind genicular nerve block on pain, muscle strength with isokinetic device, physical function and quality of life in chronic knee osteoarthritis: a prospective randomized controlled study.","Background


The genicular nerve block (GNB) is demonstrated from several reports to alleviate pain and improve knee functionality in patients with chronic knee osteoarthritis (OA). Ultrasound (US)-guided GNB has been the most used imaging method. This study aimed to compare the effectiveness of US-guided versus blind GNB in the treatment of knee OA.
Methods


This prospective, randomized clinical trial included patients with knee OA based on American College of Rheumatology diagnostic criteria. The patients were evaluated for clinical and dynamometer parameters at the baseline, 4 weeks after treatment, and 12 weeks after treatment. The patients underwent blind injection or US-guided injection.
Results


When compared with the baseline, both groups showed significant improvement in pain, physical function, and quality of life parameters. Significant differences were observed between the groups for clinical parameters (30-second chair stand test, 6-minute walk test) in favor of the US-guided group. On the other hand, blind injection was more significantly effective on some parameters of the Nottingham Health Profile. There wasn't any significant improvement in isokinetic muscle strength for either group.
Conclusions


This study demonstrated that both US-guided and blind GNB, in the treatment of knee OA, were effective in reducing symptoms and improving physical function. GNB wasn't an effective treatment for isokinetic muscle function. USguided injections may yield more effective clinical results than blind injections.",2020,"Significant differences were observed between the groups for clinical parameters (30-second chair stand test, 6-minute walk test) in favor of the US-guided group.","['chronic knee osteoarthritis', 'patients with knee OA based on American College of Rheumatology diagnostic criteria', 'patients with chronic knee osteoarthritis (OA']","['GNB', '\n\n\nThe genicular nerve block (GNB', 'ultrasound guided  versus  blind genicular nerve block', 'US-guided versus blind GNB', 'US-guided and blind GNB', 'blind injection or US-guided injection']","['isokinetic muscle strength', 'pain, physical function, and quality of life parameters', 'pain, muscle strength with isokinetic device, physical function and quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0221508,"Significant differences were observed between the groups for clinical parameters (30-second chair stand test, 6-minute walk test) in favor of the US-guided group.","[{'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Cankurtaran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ozgur Zeliha', 'Initials': 'OZ', 'LastName': 'Karaahmet', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sadik Yigit', 'Initials': 'SY', 'LastName': 'Yildiz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Eksioglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Dulgeroglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Unlu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.258']
2020,32606273,Re: Role of dexmedetomidine as adjuvant in postoperative sciatic popliteal and adductor canal analgesia in trauma patients: a randomized controlled trial.,,2020,,['postoperative sciatic popliteal and adductor canal analgesia in trauma patients'],['dexmedetomidine'],[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.236022,,"[{'ForeName': 'Ki-Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School, Jeonju, Korea.'}, {'ForeName': 'A Ram', 'Initials': 'AR', 'LastName': 'Doo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School, Jeonju, Korea.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.284']
2021,32606274,"RE: The effect of atropine in preventing catheter-related pain and discomfort in patients undergoing transurethral resection due to bladder tumor: a prospective, randomized, controlled study.",,2020,,['patients undergoing transurethral resection due to bladder tumor'],"['atropine', 'RE']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005695', 'cui_str': 'Neoplasm of bladder'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}]",[],,0.0426722,,"[{'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Soonchunhyang University Bucheon Hospial, Bucheon, Korea.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.286']
2022,32488889,Effectiveness of different parenting interventions on oral hygiene of cerebral palsy children: A randomized controlled trial.,"AIM


To assess the effectiveness of different parenting interventions for improving oral hygiene of cerebral palsy (CP) children aged 4-12 years.
METHODOLOGY AND RESULTS


A randomized controlled trial was done among 60 CP children and parents visiting a tertiary care center in New Delhi. The study population was randomly assigned to experimental or control group (30 in each group). Parents/caregivers in the experimental group (Group 1) received video-based dental health education (DHE) and the control group (Group 2) received conventional DHE. Each group also received two telephonic reinforcements at fourth and eighth week after the first intervention at baseline. The groups were assessed for sociodemographic, familial factors, medical history, oral hygiene practices, and oral hygiene status. At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05). The mean reductions seen in Group 2 were 0.03 in OHI-S, 0.14 in PI, and 0.04 in GI index (P-value < .05, except for GI score: P-value = .6).
CONCLUSION


Video-based DHE is effective and brings about significant improvement in oral hygiene status and oral health among CP children.",2020,"At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05).","['60 CP children and parents visiting a tertiary care center in New Delhi', 'cerebral palsy (CP) children aged 4-12 years', 'cerebral palsy children', 'CP children']","['Video-based DHE', 'parenting interventions', 'video-based dental health education (DHE) and the control group (Group 2) received conventional DHE']","['oral hygiene status and oral health', 'sociodemographic, familial factors, medical history, oral hygiene practices, and oral hygiene status', 'simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores']","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0610275,"At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05).","[{'ForeName': 'Vedha', 'Initials': 'V', 'LastName': 'Vpk', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Vikrant R', 'Initials': 'VR', 'LastName': 'Mohanty', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Aswini Y', 'Initials': 'AY', 'LastName': 'Balappanavar', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Juneja', 'Affiliation': 'Department of Pediatrics, Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Shivam', 'Initials': 'S', 'LastName': 'Kapoor', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12481']
2023,32485112,"Effect of Platelet-Rich Plasma on Nonsurgically Treated Acute Achilles Tendon Ruptures: A Randomized, Double-Blinded Prospective Study.","BACKGROUND


An acute Achilles tendon rupture (ATR) is a long-lasting and devastating injury. Possible biological augmentation to promote and strengthen tendon healing after an ATR would be desirable.
PURPOSE


To determine whether the application of a platelet-rich plasma (PRP) injection in nonsurgically treated ATRs may promote healing and thereby improve functional outcomes.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months. All patients were treated with an orthosis with 3 wedges for 8 weeks; full weightbearing from day 1 was allowed, combined with either 4 PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin) 14 days apart. All patients received the same instructions on an exercise program starting from week 9. Outcomes included the self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion.
RESULTS


The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group). No differences in all functional outcomes at any time points were seen between the groups. At 12 months, the injured leg did not reach normal functional values compared with the uninjured leg.
CONCLUSION


The application of PRP in nonsurgically treated ATRs did not appear to show any superior clinical and functional improvement.
REGISTRATION


NCT02417922 (ClinicalTrials.gov identifier).",2020,"The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","['40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months', 'Nonsurgically Treated Acute Achilles Tendon Ruptures']","['PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin', 'Platelet-Rich Plasma', 'platelet-rich plasma (PRP) injection']","['self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion', 'mean ATRS score']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",72.0,0.431477,"The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","[{'ForeName': 'Anders Ploug', 'Initials': 'AP', 'LastName': 'Boesen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Ilum', 'Initials': 'MI', 'LastName': 'Boesen', 'Affiliation': 'Department Of Orthopaedics, Køge Sygehus, Køge, Denmark.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Department of Orthopaedic Surgery, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lenskjold', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'CopenRehab, Section of Social Medicine, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of sports medicine,['10.1177/0363546520922541']
2024,32485622,Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial.,"OBJECTIVE


To demonstrate the effectiveness of a cognitive behavioural therapy for stress management in pregnant women in the reduction of psychological stress and hair cortisol levels.
METHODS


The trial was controlled and randomised, with a total of 78 pregnant women: control group (n-39) and Cognitive Behavioural Therapy group (n-39). To test the therapy's efficacy, an evaluation of the primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience) was conducted before and after the treatment. The therapy was conducted during 8 sessions (one per week) in a group setting. The study was registered as a Randomised Controlled Trial with the code NCT03404141.
RESULTS


The results showed a group time interaction between hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms. These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
CONCLUSIONS


Using a novel way of assessing chronic stress (psychological and objective measures as hair cortisol levels), this is the first study that has shown a decrease in both the levels of cortisol in hair and in psychological stress. This decline could have implications for maternal and fetal health.",2020,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","['78 pregnant women', 'pregnant women in the reduction of psychological stress and hair cortisol levels', 'pregnant women']","['cognitive behavioural therapy', 'cognitive-behavioural therapy', 'control group (n-39) and Cognitive Behavioural Therapy group (n-39']","['hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms', 'primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience', 'stress and hair cortisol levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",78.0,0.0699261,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Strivens-Vilchez', 'Affiliation': 'Midwifery Department, Gongora Primary Health Center, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitariaibs.GRANADA, University of Granada, Granada, Spain. Electronic address: raquel.gonzalez@ciberehd.org.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110162']
2025,32485633,Effect of hippotherapy on walking performance and gait parameters in people with multiple sclerosis.,"BACKGROUND


Walking dysfunction is one of the most common symptoms of multiple sclerosis (MS).
OBJECTIVE


To evaluate the effects of an 8-week hippotherapy intervention on walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS; and to examine whether the effects of hippotherapy on walking performance are mediated by changes in spatiotemporal gait parameters.
METHODS


Participants were assigned into a hippotherapy intervention group (n = 17) or a control group (n = 16). The intervention included 16 sessions of 30-minutes of hippotherapy conducted twice a week. Participants underwent the 25-foot walk test (T25FW) and 6-minute walk test (6MWT), as primary outcomes, and spatiotemporal gait evaluation using GaitRite system, as secondary outcomes, before and after intervention. The data were examined using mixed model ANOVA with Bonferroni post hoc. Mediation analysis was conducted as per Baron and Kenny's criteria.
RESULTS


Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control. Only balance time (p = 0.043), stance time (p = 0.031), and absolute (p = 0.004) and relative (p = 0.017) double support time were identified as significant mediators of the effects of hippotherapy on walking performance evaluated by T25FW. There was no significant mediator for 6MWT (all p>0.05).
CONCLUSION


Hippotherapy improved walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS, and changes in walking performance, evaluated by T25FW, were partially driven by reduction in stance time and double support time and increase in balance time. Hippotherapy may be a useful complimentary treatment approach for improving walking in people with MS.",2020,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","['people with relapsing-remitting MS', 'people with multiple sclerosis', 'Participants', 'people with MS']","['hippotherapy intervention', 'Hippotherapy', 'hippotherapy', '25-foot walk test (T25FW) and 6-minute walk test (6MWT']","['T25FW time', 'walking performance and spatiotemporal gait parameters', '6MWT distance', 'walking performance and gait parameters', 'stance time', 'balance time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0352318,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","[{'ForeName': 'Andréa Gomes', 'Initials': 'AG', 'LastName': 'Moraes', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil. Electronic address: deyafisio9@hotmail.com.'}, {'ForeName': 'Silvia Gonçalves Ricci', 'Initials': 'SGR', 'LastName': 'Neri', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham,Birmingham, AL, United States.'}, {'ForeName': 'Carlos Bernardo', 'Initials': 'CB', 'LastName': 'Tauil', 'Affiliation': 'Faculty of Medicine, University of Brasília, DF, Brazil.'}, {'ForeName': 'Felipe von', 'Initials': 'FV', 'LastName': 'Glehn', 'Affiliation': 'Department of Medical Clinic, Faculty of Medicine, University of Brasilia, Brasilia, DF and Department of Immunology, University of Unicamp, SP, Brazil.'}, {'ForeName': 'Éber Castro', 'Initials': 'ÉC', 'LastName': 'Corrêa', 'Affiliation': 'Clinen, Neurology and Endocrinology Clinic, Brasília, DF, Bazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'de David', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102203']
2026,32485640,Improving B-mode ultrasound diagnostic performance for focal liver lesions using deep learning: A multicentre study.,"BACKGROUND


The diagnosis performance of B-mode ultrasound (US) for focal liver lesions (FLLs) is relatively limited. We aimed to develop a deep convolutional neural network of US (DCNN-US) for aiding radiologists in classification of malignant from benign FLLs.
MATERIALS AND METHODS


This study was conducted in 13 hospitals and finally 2143 patients with 24,343 US images were enrolled. Patients who had non-cystic FLLs with pathological results were enrolled. The FLLs from 11 hospitals were randomly divided into training and internal validations (IV) cohorts with a 4:1 ratio for developing and evaluating DCNN-US. Diagnostic performance of the model was verified using external validation (EV) cohort from another two hospitals. The diagnosis value of DCNN-US was compared with that of contrast enhanced computed tomography (CT)/magnetic resonance image (MRI) and 236 radiologists, respectively.
FINDINGS


The AUC of Model LBC  for FLLs was 0.924 (95% CI: 0.889-0.959) in the EV cohort. The diagnostic sensitivity and specificity of Model LBC  were superior to 15-year skilled radiologists (86.5% vs 76.1%, p = 0.0084 and 85.5% vs 76.9%, p = 0.0051, respectively). Accuracy of Model LBC  was comparable to that of contrast enhanced CT (both 84.7%) but inferior to contrast enhanced MRI (87.9%) for lesions detected by US.
INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.",2020,"INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","['focal liver lesions using deep learning', '11 hospitals', '13 hospitals and finally 2143 patients with 24,343 US images were enrolled', 'Patients who had non-cystic FLLs with pathological results were enrolled']",['deep convolutional neural network of US (DCNN-US'],"['AUC of Model LBC  for FLLs', 'Diagnostic performance', 'diagnostic sensitivity and specificity of Model LBC  were superior to 15-year skilled radiologists']","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1318045', 'cui_str': 'AKAP13 protein, human'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]",2143.0,0.0256485,"INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Centers for Biomedical Engineering, University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'School of Mathematical Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Tianan', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, the First Affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, Jiangsu, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasound Diagnosis, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Harbin The First Hospital, Harbin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Ultrasound, Ma'anshan People's Hospital, Ma'anshan, China.""}, {'ForeName': 'Jintang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic Ultrasound, Xiangya Hospital, Changsha, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Central Theater Command General Hospital, Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Diagnostic Ultrasound, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ultrasound, Fujian Cancer Hospital&Fujian Medical University Cancer Hospita, Fuzhou, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhengrq@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: jiemi301@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine, Beihang University, Beijing, China. Electronic address: jie.tian@ia.ac.cn.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: liangping301@hotmail.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102777']
2027,32583630,Cognitive remediation therapy for patients with bipolar disorder: A randomised proof-of-concept trial.,"OBJECTIVES


Cognitive remediation therapy (CRT) may benefit people with bipolar disorder type I and II for whom cognitive impairment is a major contributor to disability. Extensive research has demonstrated CRT to improve cognition and psychosocial functioning in people with different diagnoses, but randomised trials of evidenced therapy programmes are lacking for bipolar disorders. The Cognitive Remediation in Bipolar (CRiB) study aimed to determine whether an established CRT programme is feasible and acceptable for people with bipolar disorders.
METHODS


This proof-of-concept, single-blind randomised trial recruited participants aged 18-65 with bipolar disorder, not currently experiencing an episode. They were 1:1 block randomised to treatment-as-usual (TAU) with or without individual CRT for 12 weeks. The partly computerised CRT programme (""CIRCuiTS"") was therapist-led and is evidence-based from trials in those with psychotic illnesses. Data were collected and analysed by investigators blinded to group allocation. The main outcomes (week 13 and 25) examined participant retention, intervention feasibility and putative effects of CRT on cognitive and psychosocial functioning via intention-to-treat analyses.
TRIAL REGISTRATION


ISRCTN ID32290525.
RESULTS


Sixty participants were recruited (02/2016-06/2018) and randomised to CRT (n = 29) or TAU (n = 31). Trial withdrawals were equivalent (CRT n = 2/29; TAU n = 5/31). CRT satisfaction indicated high acceptability. Intention-to-treat analyses (N = 60) demonstrated greater improvements for CRT- than TAU-randomised participants: at both week 13 and 25, CIRCuiTS participants showed larger improvements in the following domains (week 25 effect sizes reported here): IQ (SES = 0.71, 95% CI [0.29,1.13]), working memory (SES = 0.70, 95% CI [0.31,1.10]), executive function (SES = 0.93, 95% CI [0.33,1.54]), psychosocial functioning (SES = 0.49, 95% CI [0.18,0.80]) and goal attainment (SES = 2.02, 95% CI [0.89,3.14]). No serious adverse events were reported.
CONCLUSIONS


CRT is feasible for individuals with bipolar disorders and may enhance cognition and functioning. The reported effect sizes from this proof-of-concept trial encourage further investigation in a definitive trial.",2020,"No serious adverse events were reported.
","['60 participants were recruited (02/2016-06/2018) and randomised to', 'people with bipolar disorders', 'patients with bipolar disorder', 'participants aged 18-65 with bipolar disorder, not currently experiencing an episode', 'individuals with bipolar disorders']","['CRT', 'established CRT programme', 'TAU', 'Cognitive Remediation Therapy', 'Cognitive remediation therapy (CRT', 'treatment-as-usual (TAU) with or without individual CRT']","['participant retention, intervention feasibility and putative effects of CRT on cognitive and psychosocial functioning via intention-to-treat analyses', 'psychosocial functioning', 'executive function', 'working memory', 'serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.39013,"No serious adverse events were reported.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Strawbridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Dimosthenis', 'Initials': 'D', 'LastName': 'Tsapekos', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics, King's Clinical Trials Unit, King's College London, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Mantingh', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nefize', 'Initials': 'N', 'LastName': 'Yalin', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Department of Health Services and Population Research, King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Boadu', 'Affiliation': ""Department of Health Services and Population Research, King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Macritchie', 'Affiliation': 'OPTIMA Mood Disorders Service, Lambeth Hospital, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cella', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Reeder', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fish', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]",Bipolar disorders,['10.1111/bdi.12968']
2028,32585837,"Supplementation with Whey Protein, Omega-3 Fatty Acids and Polyphenols Combined with Electrical Muscle Stimulation Increases Muscle Strength in Elderly Adults with Limited Mobility: A Randomized Controlled Trial.","Age-related sarcopenia is a progressive and generalized skeletal muscle disorder associated with adverse outcomes. Herein, we evaluate the effects of a combination of electrical muscle stimulation (EMS) and a whey-based nutritional supplement (with or without polyphenols and fish oil-derived omega-3 fatty acids) on muscle function and size. Free-living elderly participants with mobility limitations were included in this study. They received 2 sessions of EMS per week and were randomly assigned to ingest an isocaloric beverage and capsules for 12 weeks: (1) carbohydrate + placebo capsules (CHO,  n  = 12), (2) whey protein isolate + placebo capsules (WPI,  n  = 15) and (3) whey protein isolate + bioactives (BIO) capsules containing omega-3 fatty acids, rutin, and curcumin (WPI + BIO,  n  = 10). The change in knee extension strength was significantly improved by 13% in the WPI + BIO group versus CHO on top of EMS, while WPI alone did not provide a significant benefit over CHO. On top of this, there was the largest improvement in gait speed (8%). The combination of EMS and this specific nutritional intervention could be considered as a new approach for the prevention of sarcopenia but more work is needed before this approach should be recommended. This trial was registered at the Japanese University Hospital Medical Information Network (UMIN) clinical trial registry (UMIN000008382).",2020,"The change in knee extension strength was significantly improved by 13% in the WPI + BIO group versus CHO on top of EMS, while WPI alone did not provide a significant benefit over CHO.","['Free-living elderly participants with mobility limitations', 'Elderly Adults with Limited Mobility']","['Supplementation with Whey Protein, Omega-3 Fatty Acids and Polyphenols Combined with Electrical Muscle Stimulation', 'isocaloric beverage and capsules for 12 weeks: (1) carbohydrate + placebo capsules (CHO,  n  = 12), (2) whey protein isolate + placebo capsules (WPI,  n  = 15) and (3) whey protein isolate + bioactives (BIO) capsules containing omega-3 fatty acids, rutin, and curcumin (WPI + BIO,  n  = 10', 'electrical muscle stimulation (EMS) and a whey-based nutritional supplement (with or without polyphenols and fish oil-derived omega-3 fatty acids']","['gait speed', 'change in knee extension strength']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700572', 'cui_str': 'Reduced mobility'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0035976', 'cui_str': 'Rutin'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",,0.0967564,"The change in knee extension strength was significantly improved by 13% in the WPI + BIO group versus CHO on top of EMS, while WPI alone did not provide a significant benefit over CHO.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Boutry-Regard', 'Affiliation': 'Nestlé Research, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Vinyes-Parés', 'Initials': 'VP', 'LastName': 'Gerard', 'Affiliation': 'Nestlé Health Science S.A., 1066 Epalinges, Switzerland.'}, {'ForeName': 'Breuillé', 'Initials': 'B', 'LastName': 'Denis', 'Affiliation': 'Nestlé Research, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Moritani', 'Initials': 'M', 'LastName': 'Toshio', 'Affiliation': 'Laboratory of Applied Physiology, Graduate School of Human and Environmental Studies, Kyoto University, Kyoto 606-8501, Japan.'}]",Nutrients,['10.3390/nu12061866']
2029,32585854,"Omega-3 Eicosapentaenoic Acid (EPA) Rich Extract from the Microalga  Nannochloropsis  Decreases Cholesterol in Healthy Individuals: A Double-Blind, Randomized, Placebo-Controlled, Three-Month Supplementation Study.","The aim of this trial is to assess the effect of Almega ® PL on improving the Omega-3 Index, cardio-metabolic parameters, and other biomarkers in generally healthy individuals. The benefits of long-chain omega-3 fatty acids for cardiovascular health are primarily built upon mixtures of docosahexaenoic (DHA) and eicosapentaenoic acids (EPA). Highly purified EPA therapy has proven to be particularly effective in the treatment of cardiovascular disease, but less is known about the benefits of EPA-only supplementation for the general healthy population. Almega ® PL is a polar rich oil (>15%) derived from the microalga  Nannochloropsis  that contains EPA (>25%) with no DHA. Participants ( n  = 120) were given a capsule of 1 g/day of either Almega ® PL or placebo for 12 weeks. Differences in the Omega-3 Index, cardiometabolic markers, and other general health indicators were measured at the baseline, six, and 12 weeks. Compared to the placebo group, Almega ® PL supplementation significantly increased the Omega-3 Index and EPA concentration from 4.96 ± 0.90 and 0.82 ± 0.37% at the baseline to 5.75 ± 0.90 and 1.27 ± 0.36 at week 12, respectively. Very-low-density lipoprotein cholesterol (VLDL) decreased by 25%, which resulted in a significant decrease in total cholesterol compared to the placebo. Interestingly, the decrease in VLDL was not associated with an increase in LDL, which seems to be a benefit associated with EPA-only based formulations. Collectively, these results show that Almega ® PL provides a natural EPA-only option to increase EPA and manage cholesterol levels in the general population.",2020,"Compared to the placebo group, Almega ® PL supplementation significantly increased the Omega-3 Index and EPA concentration from 4.96 ± 0.90 and 0.82 ± 0.37% at the baseline to 5.75 ± 0.90 and 1.27 ± 0.36 at week 12, respectively.","['generally healthy individuals', 'Participants ( n  = 120', 'Healthy Individuals']","['Almega ® PL supplementation', 'Placebo', 'Omega-3 Eicosapentaenoic Acid (EPA', 'Highly purified EPA therapy', 'Almega ® PL', 'long-chain omega-3 fatty acids', 'Almega ® PL or placebo', 'placebo']","['total cholesterol', 'Omega-3 Index, cardiometabolic markers, and other general health indicators', 'Omega-3 Index, cardio-metabolic parameters', 'Omega-3 Index and EPA concentration', 'LDL', 'VLDL', 'Very-low-density lipoprotein cholesterol (VLDL', 'EPA and manage cholesterol levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]",120.0,0.41295,"Compared to the placebo group, Almega ® PL supplementation significantly increased the Omega-3 Index and EPA concentration from 4.96 ± 0.90 and 0.82 ± 0.37% at the baseline to 5.75 ± 0.90 and 1.27 ± 0.36 at week 12, respectively.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'RDC Clinical, Brisbane 4006, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Briskey', 'Affiliation': 'RDC Clinical, Brisbane 4006, Australia.'}, {'ForeName': 'Jakob O', 'Initials': 'JO', 'LastName': 'Nalley', 'Affiliation': 'Qualitas Health, Houston, TX 77056, USA.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Ganuza', 'Affiliation': 'Qualitas Health, Houston, TX 77056, USA.'}]",Nutrients,['10.3390/nu12061869']
2030,32589058,Effects of ACEi and ARB on post-exercise hypotension induced by exercises conducted at different times of day in hypertensive men.,"BACKGROUND


Post-exercise hypotension (PEH) is greater after evening than morning exercise, but antihypertensive drugs may affect the evening potentiation of PEH. Objective: To compare morning and evening PEH in hypertensives receiving angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB).
METHODS


Hypertensive men receiving ACEi (n = 14) or ARB (n = 15) underwent, in a random order, two maximal exercise tests (cycle ergometer, 15 watts/min until exhaustion) with one conducted in the morning (7 and 9 a.m.) and the other in the evening (8 and 10 p.m.). Auscultatory blood pressure (BP) was assessed in triplicate before and 30 min after the exercises. Changes in BP (post-exercise - pre-exercise) were compared between the groups and the sessions using a two-way mixed ANOVA and considering  P  < .05 as significant.
RESULTS


In the ARB group, systolic BP decrease was greater after the evening than the morning exercise, while in the ACEi group, it was not different after the exercises conducted at the different times of the day. Additionally, after the evening exercise, systolic BP decrease was lower in the ACEi than the ARB group (ARB = -11 ± 8 vs -6 ± 6 and ACEi = -6 ± 7 vs. -8 ± 5 mmHg, evening vs. morning, respectively, P for interaction = 0.014).
CONCLUSIONS


ACEi, but not ARB use, blunts the greater PEH that occurs after exercise conducted in the evening than in the morning.",2020,"In the ARB group, systolic BP decrease was greater after the evening than the morning exercise, while in the ACEi group, it was not different after the exercises conducted at the different times of the day.","['hypertensives receiving angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB', 'hypertensive men', 'Hypertensive men receiving ACEi (n\xa0=\xa014) or ARB (n\xa0=\xa015']","['ACEi and ARB', 'maximal exercise tests (cycle ergometer']","['Changes in BP', 'systolic BP decrease', 'Auscultatory blood pressure (BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0700218,"In the ARB group, systolic BP decrease was greater after the evening than the morning exercise, while in the ACEi group, it was not different after the exercises conducted at the different times of the day.","[{'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Brito', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Luan', 'Initials': 'L', 'LastName': 'Azevêdo', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Peçanha', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Rafael Yokoyama', 'Initials': 'RY', 'LastName': 'Fecchio', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Rafael Andrade', 'Initials': 'RA', 'LastName': 'Rezende', 'Affiliation': 'Department of Nephrology, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'Giovânio Vieira', 'Initials': 'GV', 'LastName': 'da Silva', 'Affiliation': 'Hypertension Unit, General Hospital, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pio-Abreu', 'Affiliation': 'Hypertension Unit, General Hospital, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'Décio', 'Initials': 'D', 'LastName': 'Mion', 'Affiliation': 'Hypertension Unit, General Hospital, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, USA.'}, {'ForeName': 'Claudia L M', 'Initials': 'CLM', 'LastName': 'Forjaz', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1783546']
2031,32589290,Sitting decreases endothelial microparticles but not circulating angiogenic cells irrespective of lower leg exercises: a randomized cross-over trial.,"NEW FINDINGS


What is the central question of this study? What are the cellular and molecular determinants of increased risk for cardiovascular disease from prolonged sitting? What is the main finding and its importance? Prolonged sitting, independent of calf raise interruption strategies, decreases microparticle counts linked to endothelial activation and apoptosis. An acute bout of prolonged sitting appears to promote paradoxical decreases in microparticle counts, but the implications are not yet clear.
ABSTRACT


Repeated exposure to prolonged sitting increases the risk for cardiovascular disease. However, the cellular links by which repeated exposure to prolonged sitting lead to increased cardiovascular risk have not been fully elucidated, with markers of vascular damage and repair such as microparticles (MPs) and circulating angiogenic cell (CACs) being promising targets. The objective of the study was to examine the effects of 3 h of sitting with or without intermittent calf raises on annexin V +  /CD34 +  , annexin V +  /CD62E +  , and annexin V +  /CD31 +  /42b -  MP populations linked to CAC paracrine activity, endothelial activation and apoptosis, respectively, as well as CD14 +  /31 +  , CD3 +  /31 +  , and CD34 +  CACs, which are linked to endothelial repair. In a random order, 20 sedentary participants (14 females, 22 ± 3 years) remained seated for 180 min with or without performing 10 calf raises every 10 min. Blood samples were obtained after 20 min of quiet rest in the supine position before and after sitting. Overall, sitting decreased annexin V +  /CD34 +  MPs (-12 ± 5 events µl -1  , P < 0.01), annexin V +  /CD62E +  MPs (-17 ± 4 events µl -1  , P < 0.001), and annexin V +  /CD31 +  /42b -  MPs (-22 ± 6 events µl -1  , P < 0.001) regardless of condition. There were no differences in endothelin-1 plasma concentration, CD14 +  /31 +  , CD34 +  or CD3 +  /31 +  CAC frequencies. Sitting did not alter CAC number, but decreased MPs linked to endothelial activation, apoptosis and CAC paracrine activity in a manner that was independent of muscle contraction. These findings support changes in markers of endothelial activation and apoptosis with sedentary behaviour and provide new insights into altered intercellular communication with physical inactivity such as prolonged sitting.",2020,"There were no differences in endothelin-1 plasma concentration, CD14 +  /31 +  , CD34 +  or CD3 +  /31 +  CAC frequencies.","['20 sedentary participants (14 females, 22\xa0±\xa03 years) remained seated for 180 minutes with or without performing 10 calf raises every 10 minutes']","['3\xa0h of sitting with or without intermittent calf raises on Annexin V +  /CD34 +  , Annexin V +  /CD62E +  , and Annexin V +  /CD31']","['endothelin-1 plasma concentration', 'MPs linked to endothelial activation, apoptosis and CAC paracrine activity', 'sitting decreased Annexin V +  /CD34 +  MPs (-12\xa0±\xa05 events/μl, P\xa0<\xa00.01), Annexin V +  /CD62E +  MPs']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0585315', 'cui_str': 'Every ten minutes'}]","[{'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0059249', 'cui_str': 'Annexin V'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0059249', 'cui_str': 'Annexin V'}, {'cui': 'C4517393', 'cui_str': '0.01'}]",20.0,0.029173,"There were no differences in endothelin-1 plasma concentration, CD14 +  /31 +  , CD34 +  or CD3 +  /31 +  CAC frequencies.","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Shill', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, 20740, USA.'}, {'ForeName': 'Rian Q', 'Initials': 'RQ', 'LastName': 'Landers-Ramos', 'Affiliation': 'Department of Kinesiology, Towson University, Towson, MD, 21252.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Willey', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, University of Southern Mississippi, Hattiesburg, MS, 39406, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Prior', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, 20740, USA.'}]",Experimental physiology,['10.1113/EP088690']
2032,32589738,"A Phase 2, Multicenter Study of Nevanimibe for the Treatment of Congenital Adrenal Hyperplasia.","CONTEXT


Patients with classic congenital adrenal hyperplasia (CAH) often require supraphysiologic glucocorticoid doses to suppress adrenocorticotropic hormone (ACTH) and control androgen excess. Nevanimibe hydrochloride (ATR-101), which selectively inhibits adrenal cortex function, might reduce androgen excess independent of ACTH and thus allow for lower glucocorticoid dosing in CAH. 17-hydroxyprogesterone (17-OHP) and androstenedione are CAH biomarkers used to monitor androgen excess.
OBJECTIVE


Evaluate the efficacy and safety of nevanimibe in subjects with uncontrolled classic CAH.
DESIGN


This was a multicenter, single-blind, dose-titration study. CAH subjects with baseline 17-OHP ≥4× the upper limit of normal (ULN) received the lowest dose of nevanimibe for 2 weeks followed by a single-blind 2-week placebo washout. Nevanimibe was gradually titrated up if the primary outcome measure (17-OHP ≤2× ULN) was not met. A total of 5 nevanimibe dose levels were possible (125, 250, 500, 750, 1000 mg twice daily).
RESULTS


The study enrolled 10 adults: 9 completed the study, and 1 discontinued early due to a related serious adverse event. At baseline, the mean age was 30.3 ± 13.8 years, and the maintenance glucocorticoid dose, expressed as hydrocortisone equivalents, was 24.7 ± 10.4 mg/day. Two subjects met the primary endpoint, and 5 others experienced 17-OHP decreases ranging from 27% to 72% during nevanimibe treatment. The most common side effects were gastrointestinal (30%). There were no dose-related trends in adverse events.
CONCLUSIONS


Nevanimibe decreased 17-OHP levels within 2 weeks of treatment. Larger studies of longer duration are needed to further evaluate its efficacy as add-on therapy for CAH.",2020,"There were no dose-related trends in adverse events.
","['CAH subjects with baseline 17-OHP ≥ 4x the upper limit of normal (ULN', 'Congenital Adrenal Hyperplasia', 'subjects with uncontrolled classic CAH', 'The study enrolled 10 adults', 'Patients with classic congenital adrenal hyperplasia (CAH']","['nevanimibe', 'Nevanimibe', '17-hydroxyprogesterone', 'Nevanimibe hydrochloride (ATR-101', 'placebo']","['efficacy and safety', '17-OHP', 'adverse events', '17-OHP levels']","[{'cui': 'C0001627', 'cui_str': 'Congenital adrenal hyperplasia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202075', 'cui_str': '17 Hydroxyprogesterone measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C3831455', 'cui_str': 'ATR-101'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202075', 'cui_str': '17 Hydroxyprogesterone measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.044986,"There were no dose-related trends in adverse events.
","[{'ForeName': 'Diala', 'Initials': 'D', 'LastName': 'El-Maouche', 'Affiliation': 'Division of Endocrinology & Metabolism, George Washington University, Washington, DC.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Merke', 'Affiliation': 'The National Institutes of Health Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Vogiatzi', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Alice Y', 'Initials': 'AY', 'LastName': 'Chang', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Adina F', 'Initials': 'AF', 'LastName': 'Turcu', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Joyal', 'Affiliation': 'The National Institutes of Health Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Vivian H', 'Initials': 'VH', 'LastName': 'Lin', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Weintraub', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Marianne R', 'Initials': 'MR', 'LastName': 'Plaunt', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Pharis', 'Initials': 'P', 'LastName': 'Mohideen', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Auchus', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, Michigan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa381']
2033,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE


To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM).
METHODS


A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated.
RESULTS


Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
CONCLUSIONS


The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024']
2034,32592986,"A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer - The FALUCA study.","OBJECTIVES


Fruquintinib is an orally active kinase inhibitor that selectively targets the vascular endothelial growth factor (VEGF) receptor. A Phase II trial has demonstrated a significant benefit in progression-free survival (PFS) for fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy. This Phase III trial is a randomized, double-blind, multicenter trial to confirm fruquintinib's efficacy in the same patient population.
MATERIALS AND METHODS


From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study. Participants were randomized 2:1 to receive fruquintinib (n = 354) or placebo (n = 173) once daily for 3 weeks on-treatment, and 1 week off-treatment. Patients were stratified according to epidermal growth factor receptor mutation status and prior use of VEGF inhibitors. Primary endpoint was overall survival (OS).
RESULTS


Median OS was 8.9 months for the fruquintinib group and 10.4 months for placebo group (hazard ratio [HR] 1.02; 95 % confidence interval [CI], 0.82-1.28; P = 0.841), with median PFS of 3.7 months and 1.0 months, respectively (HR 0.34; 95 % CI, 0.28-0.43; P < 0.001). Objective response rate and disease control rate were 13.8 % and 66.7 % for fruquintinib, and 0.6 % and 24.9 % for placebo, respectively (P < 0.001). Hypertension was the most frequent treatment-emergent adverse event (≥grade 3) observed in fruquintinib-treated patients (21.0 %). Post hoc analysis revealed that fruquintinib prolonged the median OS for patients who did not receive subsequent antitumor therapy: 7.0 months versus 5.1 months for placebo (HR 0.65; 95 % CI, 0.46-0.91; P = 0.012). Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
CONCLUSION


Although the study did not meet its primary endpoint, fruquintinib could be effective in combination with other agents for the treatment of patients with NSCLC who have failed second-line chemotherapy.",2020,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
","['patients with NSCLC who have failed second-line chemotherapy', 'Chinese patients with advanced nonsquamous non-small-cell lung cancer ', 'From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study', 'same patient population', 'fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy']",['placebo'],"['Objective response rate and disease control rate', 'Median OS', 'Hypertension', 'fruquintinib prolonged the median OS', 'quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires', 'progression-free survival (PFS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",730.0,0.694568,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, China. Electronic address: shunlu@sjtu.edu.cn.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Harbin Medical University Cancer Hospital, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'XuZhou Central Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'The Second Hospital of Anhui Medical University, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Xiamen Key Laboratory of Antitumor Drug Transformation Research, The First Affiliated Hospital of Xiamen University, China.'}, {'ForeName': 'Junguo', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nantong Tumor Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Linyi Cancer Hospital, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""The Fifth Medical Center, General Hospital of the People's Liberation Army, China.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Cancer Hospital, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, China.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'The Second Xiangya Hospital of Central South University, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ""Jiangyin People's Hospital, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Hubei Cancer Hospital, China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'West China Hospital of Sichuan University, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Xinjiang Cancer Hospital, China.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Affiliated Hospital of Guangdong Medical University, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Jinling Hospital, Nanjing University School of Medicine, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Shanghai Changhai Hospital, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Northern Jiangsu People's Hospital, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Liaoning Cancer Hospital, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'General Hospital of Northern Theater Command, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'General Hospital of Ningxia Medical University, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Jie', 'Affiliation': ""The Fifth People's Hospital of Shanghai, China.""}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, China.'}, {'ForeName': 'Wangjun', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Nanfang Hospital of Southern Medical University, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital Affiliated with School of Medicine, Zhejiang University, China.'}, {'ForeName': 'Dongning', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'The Fourth Affiliated Hospital of Guangxi Medical University, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Hust, China.'}, {'ForeName': 'Jinji', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Guandong Provincial People's Hospital, China.""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, China.""}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Hangzhou First People's Hospital, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Peking University Third Hospital, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'The First Affiliated Hospital of Soochow University, China.'}, {'ForeName': 'Yijiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Hainan General Hospital, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, China.'}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Yunnan Cancer Hospital, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.016']
2035,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE


To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK).
METHOD


The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting.
RESULTS


The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed.
CONCLUSION


Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005']
2036,32613644,A preliminary comparison of the efficacy of online Acceptance and Commitment Therapy (ACT) and Cognitive Behavioural Therapy (CBT) stress management interventions for social and healthcare workers.,"Social and healthcare workers have been shown to experience greater levels of illness, depression and burnout as a result of chronic workplace stress. The purpose of this study was to examine whether brief online ACT and CBT interventions could reduce the experience of stress and burnout in employees, while also improving mental health and psychological flexibility. A total of 42 individuals working within the social and healthcare professions were randomly assigned to either a 2-week online ACT or CBT intervention. Recruitment was undertaken internationally, although the majority of participants were based in Ireland at the time of their participation (79%). Participants' perceived stress, burnout, mental health and work-related psychological flexibility were assessed at baseline and post-treatment. Intent-to-treat analyses were conducted on all data. Outcomes indicated that both interventions resulted in significant improvements in stress, burnout and mental health scores from baseline to post-treatment. No significant differences were observed between ACT and CBT conditions, or in psychological flexibility scores from baseline to post-treatment. Reliable Change Index (RCI) scores indicated that clinically significant improvements in stress and mental health were seen in 42% and 19% of programme-completers, respectively. These results provide preliminary evidence for the usefulness of brief internet-delivered ACT and CBT interventions for the treatment of occupational stress and its comorbid symptoms. Online programmes with a longer duration and additional therapist support should be evaluated, as these may improve the outcomes of future interventions.",2020,"Outcomes indicated that both interventions resulted in significant improvements in stress, burnout and mental health scores from baseline to post-treatment.","['42 individuals working within the social and healthcare professions', 'social and healthcare workers']","['ACT and CBT interventions', 'online ACT or CBT intervention', 'online Acceptance and Commitment Therapy (ACT) and Cognitive Behavioural Therapy (CBT) stress management interventions', 'online ACT and CBT interventions']","['stress, burnout, mental health and work-related psychological flexibility', 'psychological flexibility scores', 'stress and mental health', 'Reliable Change Index (RCI) scores', 'stress, burnout and mental health scores', 'mental health and psychological flexibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",42.0,0.061123,"Outcomes indicated that both interventions resulted in significant improvements in stress, burnout and mental health scores from baseline to post-treatment.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Barrett', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Stewart', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}]",Health & social care in the community,['10.1111/hsc.13074']
2037,32609523,Effectiveness of Resistive Vibration Exercise and Whey Protein Supplementation Plus Alkaline Salt on the Skeletal Muscle Proteome Following 21 Days of Bed Rest in Healthy Males.,"Muscle atrophy is a deleterious consequence of physical inactivity and is associated with increased morbidity and mortality. The aim of this study was to decipher the mechanisms involved in disuse muscle atrophy in eight healthy men using a 21 day bed rest with a cross-over design (control, with resistive vibration exercise (RVE), or RVE combined with whey protein supplementation and an alkaline salt (NEX)). The main physiological findings show a significant reduction in whole-body fat-free mass (CON -4.1%, RVE -4.3%, NEX -2.7%,  p  < 0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%,  p  < 0.05), and maximal voluntary contraction (CON -15%, RVE -12%, and NEX -9.5%,  p  < 0.05) and a reduction in mitochondrial enzyme activity (CON -30.7%, RVE -31.3%, NEX -17%,  p  < 0.05). The benefits of nutrition and exercise countermeasure were evident with an increase in leg lean mass (CON -1.7%, RVE +8.9%, NEX +15%,  p  < 0.05). Changes to the vastus lateralis muscle proteome were characterized using mass spectrometry-based label-free quantitative proteomics, the findings of which suggest alterations to cell metabolism, mitochondrial metabolism, protein synthesis, and degradation pathways during bed rest. The observed changes were partially mitigated during RVE, but there were no significant pathway changes during the NEX trial. The mass spectrometry proteomics data have been deposited to the ProteomeXchange Consortium with the dataset identifier PXD006882. In conclusion, resistive vibration exercise, when combined with whey/alkalizing salt supplementation, could be an effective strategy to prevent skeletal muscle protein changes, muscle atrophy, and insulin sensitivity during medium duration bed rest.",2020,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","['21 days of bedrest in healthy males', '8 healthy men using']","['resistive vibration exercise', '21-day bed rest with a cross-over design (control, with resistive vibration exercise (RVE) or RVE combined with whey protein supplementation and an alkaline salt (NEX', 'resistive vibration exercise and whey protein supplementation plus alkaline salt']","['whole body fat free mass', 'mitochondrial enzyme activity', 'maximal voluntary contraction ', 'morbidity and mortality', 'maximal oxygen consumption', 'leg lean mass']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",8.0,0.031534,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Kenny', 'Affiliation': '3U Diabetes Partnership, School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Tascher', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ziemianin', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}, {'ForeName': 'Floriane', 'Initials': 'F', 'LastName': 'Rudwill', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Zahariev', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chery', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Gauquelin-Koch', 'Affiliation': ""Centre National d'Etudes Spatiales (CNES), Paris 75001, France.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Barielle', 'Affiliation': 'Institut de Médecine et de Physiologie Spatiales, Toulouse 31400, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heer', 'Affiliation': 'Profil, Hellersbergstrasse 9, Neuss D-41460, Germany.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Blanc', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': ""O'Gorman"", 'Affiliation': '3U Diabetes Partnership, School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bertile', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}]",Journal of proteome research,['10.1021/acs.jproteome.0c00256']
2038,32609979,Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children.,"BACKGROUND


Evidence regarding the appropriate duration of treatment with antibiotic agents in children with pneumonia in low-resource settings in Africa is lacking.
METHODS


We conducted a double-blind, randomized, controlled, noninferiority trial in Lilongwe, Malawi, to determine whether treatment with amoxicillin for 3 days is less effective than treatment for 5 days in children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age). Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia were randomly assigned to receive amoxicillin twice daily for either 3 days or 5 days. Children were followed for 14 days. The primary outcome was treatment failure by day 6; noninferiority of the 3-day regimen to the 5-day regimen would be shown if the percentage of children with treatment failure in the 3-day group was no more than 1.5 times that in the 5-day group. Prespecified secondary analyses included assessment of treatment failure or relapse by day 14.
RESULTS


From March 29, 2016, to April 1, 2019, a total of 3000 children underwent randomization: 1497 children were assigned to the 3-day group, and 1503 to the 5-day group. Among children with day 6 data available, treatment failure had occurred in 5.9% in the 3-day group (85 of 1442 children) and in 5.2% (75 of 1456) in the 5-day group (adjusted difference, 0.7 percentage points; 95% confidence interval [CI], -0.9 to 2.4) - a result that satisfied the criterion for noninferiority of the 3-day regimen to the 5-day regimen. Among children with day 14 data available, 176 of 1411 children (12.5%) in the 3-day group and 154 of 1429 (10.8%) in the 5-day group had had treatment failure by day 6 or relapse by day 14 (between-group difference, 1.7 percentage points; 95% CI, -0.7 to 4.1). The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).
CONCLUSIONS


In HIV-uninfected Malawian children, treatment with amoxicillin for chest-indrawing pneumonia for 3 days was noninferior to treatment for 5 days. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02678195.).",2020,"The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).
","['1497 children', 'children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age', 'Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia', 'Malawian Children', '3000 children underwent randomization', 'children with pneumonia in low-resource settings in Africa']","['amoxicillin', 'antibiotic agents', 'Amoxicillin']","['percentage of children with treatment failure', 'assessment of treatment failure or relapse by day 14', 'percentage of children with serious adverse events', 'treatment failure by day 6 or relapse']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3000.0,0.259317,"The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).
","[{'ForeName': 'Amy-Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Melda', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Chifundo B', 'Initials': 'CB', 'LastName': 'Ndamala', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Ajib', 'Initials': 'A', 'LastName': 'Phiri', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}]",The New England journal of medicine,['10.1056/NEJMoa1912400']
2039,32609980,Randomized Trial of Amoxicillin for Pneumonia in Pakistan.,"BACKGROUND


The World Health Organization (WHO) recommends oral amoxicillin for patients who have pneumonia with tachypnea, yet trial data indicate that not using amoxicillin to treat this condition may be noninferior to using amoxicillin.
METHODS


We conducted a double-blind, randomized, placebo-controlled noninferiority trial involving children at primary health care centers in low-income communities in Karachi, Pakistan. Children who were 2 to 59 months of age and who met WHO criteria for nonsevere pneumonia with tachypnea were randomly assigned to a 3-day course of a suspension of amoxicillin (the active control) of 50 mg per milliliter or matched volume of placebo (the test regimen), according to WHO weight bands (500 mg every 12 hours for a weight of 4 to <10 kg, 1000 mg every 12 hours for a weight of 10 to <14 kg, or 1500 mg every 12 hours for a weight of 14 to <20 kg). The primary outcome was treatment failure during the 3-day course of amoxicillin or placebo. The prespecified noninferiority margin was 1.75 percentage points.
RESULTS


From November 9, 2014, through November 30, 2017, a total of 4002 children underwent randomization (1999 in the placebo group and 2003 in the amoxicillin group). In the per-protocol analysis, the incidence of treatment failure was 4.9% among placebo recipients (95 of 1927 children) and 2.6% among amoxicillin recipients (51 of 1929 children) (between-group difference, 2.3 percentage points; 95% confidence interval [CI], 0.9 to 3.7). Results were similar in the intention-to-treat analysis. The presence of fever and wheeze predicted treatment failure. The number needed to treat to prevent one treatment failure was 44 (95% CI, 31 to 80). One patient (<0.1%) in each group died. Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group.
CONCLUSIONS


Among children younger than 5 years of age with nonsevere pneumonia, the frequency of treatment failure was higher in the placebo group than in the amoxicillin group, a difference that did not meet the noninferiority margin for placebo. (Funded by the Joint Global Health Trials Scheme [of the Department for International Development, Medical Research Council, and Wellcome] and others; RETAPP ClinicalTrials.gov number, NCT02372461.).",2020,"Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group.
","['patients who have pneumonia with tachypnea', 'Children who were 2 to 59 months of age and who met WHO criteria for nonsevere pneumonia with tachypnea', 'children at primary health care centers in low-income communities in Karachi, Pakistan', 'Pneumonia in Pakistan', 'children younger than 5 years of age with nonsevere pneumonia', 'From November 9, 2014, through November 30, 2017, a total of 4002 children underwent randomization (1999 in the placebo group and 2003 in the']","['amoxicillin', 'suspension of amoxicillin (the active control) of 50 mg per milliliter or matched volume of placebo', 'Amoxicillin', 'placebo']","['Relapse', 'number needed to treat to prevent one treatment failure', 'treatment failure during the 3-day course of amoxicillin or placebo', 'incidence of treatment failure', 'frequency of treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",4002.0,0.735183,"Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group.
","[{'ForeName': 'Fyezah', 'Initials': 'F', 'LastName': 'Jehan', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Nisar', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Kerai', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Benazir', 'Initials': 'B', 'LastName': 'Balouch', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Najeeb', 'Initials': 'N', 'LastName': 'Rahman', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Shafiq', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}]",The New England journal of medicine,['10.1056/NEJMoa1911998']
2040,32610246,Structure and process associated with the efficiency of intensive care units in low-resource settings: An analysis of the CHECKLIST-ICU trial database.,"PURPOSE


Characteristics of structure and process impact ICU performance and the outcomes of critically ill patients. We sought to identify organizational characteristics associated with efficient ICUs in low-resource settings.
MATERIALS AND METHODS


This is a secondary analysis of a multicenter cluster-randomized clinical trial in Brazil (CHECKLIST-ICU). Efficient units were defined by standardized mortality ratio (SMR) and standardized resource use (SRU) lower than the overall medians and non-efficient otherwise. We used a regularized logistic regression model to evaluate associations between organizational factors and efficiency.
RESULTS


From 118 ICUs (13,635 patients), 47 units were considered efficient and 71 non-efficient. Efficient units presented lower incidence rates (median[IQR]) of central line-associated bloodstream infections (4.95[0.00-22.0] vs 6.29[0.00-25.6], p = .04), utilization rates of mechanical ventilation (0.41[0.07-0.73] vs 0.58[0.19-0.82], p < .001), central venous catheter (0.67[0.15-0.98] vs 0.78[0.33-0.98], p = .04), and indwelling urinary catheter (0.62[0.22-0.95] vs 0.76[0.32-0.98], p < .01) than non-efficient units. The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
CONCLUSIONS


In low-resource settings, active surveillance of nosocomial infections and the utilization of invasive devices were associated with efficiency, supporting the management and evaluation of performance indicators as a starting point for improvement in ICU.",2020,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
","['critically ill patients', 'low-resource settings', 'From 118 ICUs (13,635 patients']",[],"['utilization of central venous catheters', 'utilization rates of mechanical ventilation', 'central venous catheter', 'standardized mortality ratio (SMR) and standardized resource use (SRU', 'incidence rates (median[IQR]) of central line-associated bloodstream infections', 'indwelling urinary catheter']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4517542', 'cui_str': '118'}]",[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0521197', 'cui_str': 'Indwelling urinary catheter'}]",,0.219858,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
","[{'ForeName': 'Leonardo S L', 'Initials': 'LSL', 'LastName': 'Bastos', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': ""Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.'}, {'ForeName': 'Jorge I F', 'Initials': 'JIF', 'LastName': 'Salluh', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Bozza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil; Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, RJ, Brazil. Electronic address: fernando.bozza@ini.fiocruz.br.""}]",Journal of critical care,['10.1016/j.jcrc.2020.06.008']
2041,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
2042,32615679,"Efficacy and Safety of Naftopidil in Patients With Neurogenic Lower Urinary Tract Dysfunction: An 8-Week, Active-Controlled, Stratified-Randomized, Double-Blind, Double-Dummy, Parallel Group, Noninferiority, Multicenter Design.","PURPOSE


The aim of this study was to evaluate the efficacy and safety of naftopidil compared with tamsulosin in patients with neurogenic lower urinary tract dysfunction (LUTD).
METHODS


This study was conducted as an 8-week, active-controlled, stratified-randomized, double-blind, double-dummy, parallel group, noninferiority, and multicenter clinical trial. After 2 weeks of screening, eligible subjects were randomly assigned to receive naftopidil (25 mg for 1 week followed by 75 mg for 7 weeks) or tamsulosin (0.2 mg for 8 weeks). Primary endpoint was a change of International Prostatic Symptom Score (IPSS) total score after 8 weeks of treatment.
RESULTS


One hundred ninety-four subjects with neurogenic LUTD were included into this trial. There were no differences between the 2 groups in baseline characteristics, including urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder. The medication compliance rate was 94.0% (naftopidil, 93.6%; tamsulosin, 94.4%). There was a statistically significant decrease of IPSS total score at 8 weeks versus baseline in both the naftopidil (-5.64±0.66) and tamsulosin (-6.53±0.65) groups (P<0.0001 each). The mean difference between both groups was 0.89 (upper limit of 95% confidential interval, 2.72), which was lower than the noninferiority limit of 3 points. A subgroup analysis of neurologic lesions and sex found no mean difference of IPSS total score in each group. There was also no difference in safety profiles, including treatment emergent adverse events.
CONCLUSION


Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.",2020,Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.,"['patients with neurogenic lower urinary tract dysfunction (LUTD', 'One hundred ninety-four subjects with neurogenic LUTD', 'Patients With Neurogenic Lower Urinary Tract Dysfunction', 'patients with neurogenic LUTD']","['naftopidil', 'Naftopidil', 'tamsulosin']","['Efficacy and Safety', 'urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder', 'IPSS total score', 'safety profiles', 'change of International Prostatic Symptom Score (IPSS) total score', 'efficacy and safety', 'medication compliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0083701', 'cui_str': 'naftopidil'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",194.0,0.49413,Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.,"[{'ForeName': 'Hyun Hwan', 'Initials': 'HH', 'LastName': 'Sung', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Jang Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",International neurourology journal,['10.5213/inj.1938198.099']
2043,32615683,"Commentary on ""Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials"".",,2020,,['Treating Children With Overactive Bladder'],['Transcutaneous Electrical Nerve Stimulation'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]",[],,0.0990578,,"[{'ForeName': 'Isabel Casal', 'Initials': 'IC', 'LastName': 'Beloy', 'Affiliation': ""Pediatric Urology Division, Pediatric Surgery Department, University Children's Hospital of A Coruña, A Coruña, Spain.""}, {'ForeName': 'Miriam García', 'Initials': 'MG', 'LastName': 'González', 'Affiliation': ""Pediatric Urology Division, Pediatric Surgery Department, University Children's Hospital of A Coruña, A Coruña, Spain.""}, {'ForeName': 'Iván Somoza', 'Initials': 'IS', 'LastName': 'Argibay', 'Affiliation': ""Pediatric Urology Division, Pediatric Surgery Department, University Children's Hospital of A Coruña, A Coruña, Spain.""}]",International neurourology journal,['10.5213/inj.2040164.082']
2044,32615684,"Reply to Commentary on ""Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials"".",,2020,,['Treating Children With Overactive Bladder'],['Transcutaneous Electrical Nerve Stimulation'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]",[],,0.0839461,,"[{'ForeName': 'Zhongbao', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Yuanshan', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Shandong, China.'}]",International neurourology journal,['10.5213/inj.2040168.084']
2045,32616067,ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


PRIMARY OBJECTIVE: To determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers.
SECONDARY OBJECTIVES


1) To determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers. 2) To compare the number of COVID-19 cases between each trial arm on the basis of positive tests (as per current clinical testing methods and/or serology) 3) To compare the percentage of COVID-19 positive individuals with current testing methods versus serologically-proven COVID-19 in each trial arm 4) To compare COVID-19 disease severity in each trial arm 5) To compare recovery time from COVID-19 infection in each trial arm EXPLORATORY OBJECTIVES: 1) To determine compliance (as measured by trough pharmacokinetic hydroxychloroquine levels) on COVID-19 positive tests 2) To determine if genetic factors determine susceptibility to COVID-19 disease or response to treatment 3) To determine if blood group determines susceptibility to COVID-19 disease 4) To compare serum biomarkers of COVID-19 disease in each arm TRIAL DESIGN: Double-blind, multi-centre, 2-arm (3:3:2 ratio) randomised placebo-controlled trial PARTICIPANTS: National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19. Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19.
INCLUSION CRITERIA


To be included in the trial the participant MUST: 1) Have given written informed consent to participate 2) Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care EXCLUSION CRITERIA: The presence of any of the following will mean participants are ineligible: 1) Known COVID-19 positive test at baseline (if available) 2) Symptomatic for possible COVID-19 at baseline 3) Known hypersensitivity reaction to hydroxychloroquine, chloroquine or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert's syndrome is permitted) 10) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 11) Currently taking any of the following contraindicated medications: Digoxin, Chloroquine, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Ciprofloxacin, Clarithromycin, Prochlorperazine, Fluconazole 12) Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine 13) Currently breastfeeding 14) Unable to be followed-up during the trial 15) Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit 16) Not able to use or have access to a modern phone device/web-based technology 17) Any other clinical reason which may preclude entry in the opinion of the investigator INTERVENTION AND COMPARATOR: Interventions being evaluated are: A) Daily hydroxychloroquine or B) Weekly hydroxychloroquine or C) Placebo The maximum treatment period is approximately 13 weeks per participant. Hydroxychloroquine-identical matched placebo tablets will ensure that all participants are taking the same number and dosing regimen of tablets across the three trial arms. There is no variation in the dose of hydroxychloroquine by weight. The dosing regimen for the three arms of the study (A, B, C) are described in further detail below. Arm A: Active Hydroxychloroquine (- daily dosing and placebo-matched hydroxychloroquine - weekly dosing). Form: Tablets Route: Oral. Dose and Frequency: Active hydroxychloroquine: Days 1-2: Loading phase - 400mg (2 x 200mg tablets) taken twice a day for 2 days Days 3 onwards: Maintenance Phase - 200mg (1 x 200mg tablet) taken once daily, every day for 90 days (~3 months) Matched Placebo hydroxychloroquine: Days 3 onwards: Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7 th  day) for 90 days (~3 months) Arm B: Active Hydroxychloroquine (- weekly dosing and placebo matched hydroxychloroquine - daily dosing.) Form: Tablets Route: Oral. Dose and Frequency: Active hydroxychloroquine: Days 1-2: Loading Phase - 400mg (2 x 200mg tablets) taken twice daily for 2 days Days 3 onwards: Maintenance Phase - 400mg (2 x 200mg tablets) taken once a week on the same day each week (every 7 th  day) for 90 days (~3 months) Matched Placebo hydroxychloroquine: Days 3 onwards: Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Arm C: Matched placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing.) Form: Table. Route: Oral. Frequency: Matched placebo hydroxychloroquine - daily dosing: Days 1-2: Loading Phase - 2 tablets taken twice daily for 2 days Days 3 onwards: Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Matched placebo hydroxychloroquine - weekly dosing: Days 3 onwards: Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7th day) for 90 days (~3 months) A schematic of the dosing schedule can be found in the full study protocol (Additional File 1).
MAIN OUTCOMES


Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test) RANDOMISATION: Participants will be randomised to either hydroxychloroquine dosed daily with weekly placebo, HCQ dosed weekly with daily placebo, or placebo dosed daily and weekly. Randomisation will be in a 3:3:2 ratio [hydroxychloroquine-(daily), hydroxychloroquine-(weekly), placebo], using stratified block randomisation. Random block sizes will be used, and stratification will be by study site.
BLINDING (MASKING)


Participants and trial investigators consenting participants, delivering trial assessments and procedures will be blinded to intervention.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A sufficient number of participants will be enrolled so that approximately 1000 participants in total will have data suitable for the primary statistical analysis. It is anticipated that approximately 1,200 participants will need to be enrolled in total, to allow for a 20% dropout over the period of the trial. This would result in approximately 450:450:300 participants randomised to hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo daily and weekly.
TRIAL STATUS


V 1.0, 7 th  April 2020 EU Clinical Trials Register EudraCT Number: 2020-001331-26 Date of registration: 14 th  April 2020 Trial registered before first participant enrolment. Trial site is Cambridge University Hospitals NHS Foundation Trust. Recruitment started on 11 th  May 2020. It is anticipated that the trial will run for 12 months. The recruitment end date cannot yet be accurately predicted.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,There is no variation in the dose of hydroxychloroquine by weight.,"['V 1.0, 7 th  April 2020', '10', 'Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care EXCLUSION CRITERIA', ""or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert's syndrome is permitted"", 'Frequency', ' 2020-001331-26 Date of registration', '14 th  April 2020', 'approximately 1,200 participants will need to be enrolled in total', 'National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19', 'frontline healthcare workers', 'Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19', 'COVID-19 positive tests 2', '1']","['placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing', 'Placebo', 'Active hydroxychloroquine', 'hydroxychloroquine', 'Weekly hydroxychloroquine or C', 'Active Hydroxychloroquine (- daily dosing and placebo-matched hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine 13', 'Hydroxychloroquine-identical matched placebo tablets', 'placebo hydroxychloroquine', 'placebo, HCQ dosed weekly with daily placebo, or placebo', 'placebo hydroxychloroquine - daily dosing', 'hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo', 'Placebo hydroxychloroquine', 'Digoxin, Chloroquine, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Ciprofloxacin, Clarithromycin, Prochlorperazine, Fluconazole 12', 'hydroxychloroquine or B', 'hydroxychloroquine, chloroquine', 'placebo']","['Dose and Frequency', 'Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0048060', 'cui_str': '4-aminoquinoline'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0017551', 'cui_str': ""Gilbert's syndrome""}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",1200.0,0.731188,There is no variation in the dose of hydroxychloroquine by weight.,"[{'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'McEniery', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fisk', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK. mf503@medschl.cam.ac.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miles', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Kaloyirou', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hubsch', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}]",Trials,['10.1186/s13063-020-04543-4']
2046,32583313,"Allisartan Isoproxil Improves Endothelial Function and Vascular Damage in Patients with Essential Hypertension: A Single-Center, Open-Label, Randomized Controlled Trial.","INTRODUCTION


Allisartan isoproxil is a novel angiotensin II type 1 receptor antagonist that has been confirmed to lower blood pressure and protect target organs effectively. However, its role in improving endothelial function and vascular damage has not been investigated yet.
METHODS


Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99 mmHg) with age from 25-75 years were randomly assigned 1:1 to either the allisartan group (allisartan 240 mg/day and lifestyle modification) or the lifestyle modification group and were followed up for 30 days. Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage. In addition, we enrolled 36 normotensive individuals as healthy control.
RESULTS


Seventy-two mildly hypertensive patients were enrolled in this study. After 30 days of treatment, a significant increase in FMD was observed in the allisartan group (0.9 ± 0.7%, p < 0.001) and remained unchanged in the lifestyle modification group, but the difference between the two groups did not reach statistical significance (p = ns). EMPs, baPWV, SBP and DBP decreased by 251.0 ± 255.9 counts/μl (p < 0.001), 102.8 ± 84.2 cm/s (p < 0.001), 13.20 ± 3.9 mmHg (p < 0.001) and 9.35 ± 2.5 mmHg (p < 0.001), respectively, in the allisartan group, while by 21.3 ± 84.3 counts/μl (p = ns), 0.4 ± 22.0 cm/s (p = ns), 3.2 ± 6.0 mmHg (p < 0.01) and 1.0 ± 2.5 mmHg (p = ns), respectively, in the lifestyle modification group. All of the indexes above achieved statistical significance between the allisartan and lifestyle modification groups (p < 0.05). Besides, after 30 days of allisartan administration baPWV and EMPs were comparable to those measured in the healthy control group, while the difference in SBP, DBP and FMD remained significant between the allisartan and healthy control groups (p < 0.05).
CONCLUSION


The present study demonstrates for the first time that allisartan isoproxil exerts a favorable effect on improving endothelial function and vascular damage in patients with mild EH, making it a promising drug for management of EH.
CLINICAL TRIAL REGISTRATION


ChiCTR2000032332.",2020,"Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage.","['patients with mild EH', 'Seventy-two mildly hypertensive patients', 'Patients with Essential Hypertension', 'Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99\xa0mmHg) with age from 25-75\xa0years', '36 normotensive individuals as healthy control']","['allisartan group (allisartan 240\xa0mg/day and lifestyle modification) or the lifestyle modification', 'Allisartan Isoproxil']","['EMPs, baPWV, SBP and DBP', 'Endothelial Function and Vascular Damage', 'FMD', 'SBP, DBP and FMD', 'Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial\xa0microparticles (EMPs', 'endothelial function and vascular damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3849367', 'cui_str': 'allisartan isoproxil'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",36.0,0.0670531,"Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage.","[{'ForeName': 'Gaoxing', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuanya', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China. taojungz123@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01413-y']
2047,32580451,The Effect of an Online Sugar Fact Intervention: Change of Mothers with Young Children.,"Research indicates that high sugar intake in early childhood may increase risks of tooth decay, obesity and chronic disease later in life. In this sugar fact study, we explored whether an online intervention which focused on comprehensive and useful information about nutrition labels impacted mother's choice of low sugar food. The intervention was developed on the basis of the theory of planned behavior. In total, 122 mothers were recruited. Mothers were divided into an online-only group and a plus group. Knowledge of sugar and nutrition labels, behavioral attitudes, perceived behavioral control, behavioral intentions and behavior towards purchasing low-sugar products with nutrition labels were collected. After the intervention, both groups exhibited significantly enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior. Compared to the online-only group, knowledge, perceived behavioral control and behavior of the plus group significantly improved. After the intervention, about 40% of the plus group and 80% of the online-only group still did not know the World Health Organization (WHO) sugar recommendations. Understanding sugar recommendations and using nutrition labels are crucial to help people control calorie and sugar intake. Further research with a larger sample is warranted to evaluate the effects of the intervention on long-term changes in shopping behavior. More efficient and convenient nutrition education is required to increase public awareness of sugar recommendations and help people control calorie and sugar intake.",2020,"After the intervention, both groups exhibited significantly enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior.","['Mothers with Young Children', '122 mothers were recruited']","['online-only group still did not know the World Health Organization (WHO) sugar recommendations', 'Online Sugar Fact Intervention']","['knowledge, perceived behavioral control and behavior', 'enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1880386', 'cui_str': ""Don't know""}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",122.0,0.0263722,"After the intervention, both groups exhibited significantly enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior.","[{'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Huang', 'Affiliation': 'Research Center of Health Equity, College of Public Health, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chien', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}, {'ForeName': 'Mei Chun', 'Initials': 'MC', 'LastName': 'Chen', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}]",Nutrients,['10.3390/nu12061859']
2048,32585738,Non-specific analgesia during a clinical trial in fibromyalgia.,"BACKGROUND


When patients suffering from fibromyalgia undergo a therapeutic trial, a non-negligible part of analgesia is not explained by the drug itself. The mechanisms of this non-specific effect need to be understood.
MATERIALS AND METHODS


We undertook secondary analyses of a double-blind randomized trial in fibromyalgia patients in which 100 mg/day milnacipran was not found superior to placebo. Data from 49 patients belonging to both groups were pooled. Both before treatment and one month after treatment, all patients underwent a CaNTAB ®  neuropsychological test (related to spatial planning, reaction time, decision-making and risk-taking, and ability to name objects), and measurements of sensation and pain thresholds to heat and cold, supraliminal heat pain threshold, punctuate mechanical pain threshold and temporal summation, mechanical allodynia to skin brushing, and response to conditioned pain modulation. We studied the baseline predictors of analgesia and the indicators of change associated to analgesia separately. A stepwise approach was used to select the factors to enter into the final ANCOVAs, in which age, body mass index, treatment group and pain at baseline were covariates.
RESULTS


No baseline predictor of non-specific analgesia other than pain at baseline was found to be predictive. Conversely, several neuropsychological (higher performance) or psychophysical (lower sensitivity) changes correlated with analgesia in unadjusted analyses. Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia.
CONCLUSIONS


The changes observed concomitantly to non-specific pain analgesia might be related to mild changes in brain functioning, based on convergent literature data.",2020,"Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia.
","['49 patients belonging to both groups were pooled', 'patients suffering from fibromyalgia undergo a therapeutic trial', 'fibromyalgia patients in which 100mg/day']","['milnacipran', 'placebo']","['spatial planning, reaction time, decision-making and risk-taking, and ability to name objects), and measurements of sensation and pain thresholds to heat and cold, supraliminal heat pain threshold, punctuate mechanical pain threshold and temporal summation, mechanical allodynia to skin brushing, and response to conditioned pain modulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1533126', 'cui_str': 'milnacipran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C2936719', 'cui_str': 'Allodynia, Mechanical'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",49.0,0.116055,"Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Macian', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Giron', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.'}]",European journal of clinical investigation,['10.1111/eci.13337']
2049,32588060,"Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial.","AIM


The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions.
METHODS AND RESULTS


In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20-0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19-1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772).
CONCLUSION


For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting.
STUDY REGISTRATION


http://www.clinicaltrials.com; Identifier: NCT02284750.",2020,"At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772).
","['653 patients with complex bifurcation lesions at 49 international centres', 'patients with DEFINITION criteria-defined complex coronary bifurcation lesions', 'patients with complex coronary bifurcation lesions']","['stent and provisional stenting techniques', 'systematic two-stent technique (two-stent group) or provisional stenting (provisional group']","['clinical outcomes', 'incidence of cardiac death', 'TLF', 'TVMI', 'clinically driven TLR', 'composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",653.0,0.323233,"At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772).
","[{'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': ""Division of Cardiology, Xijing Hospital, 4th Military Medical University, Xi'an, China.""}, {'ForeName': 'Teguh', 'Initials': 'T', 'LastName': 'Santoso', 'Affiliation': 'Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarta, Indonesia.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Munawar', 'Affiliation': 'Division of Cardiology, Binawaluya Cardiac Center, Jakarta, Indonesia.'}, {'ForeName': 'Damras', 'Initials': 'D', 'LastName': 'Tresukosol', 'Affiliation': 'Division of Cardiology, Medicine Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Guangzhou Red Cross Hospital, Guangzhou, China.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Sheiban', 'Affiliation': 'Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Oriental General Hospital, Huainan, China.'}, {'ForeName': 'Nai-Liang', 'Initials': 'NL', 'LastName': 'Tian', 'Affiliation': 'Division of Cardiology, Nanjing Heart Center, Nanjing, China.'}, {'ForeName': 'Alfredo E', 'Initials': 'AE', 'LastName': 'Rodríguez', 'Affiliation': 'Division of Cardiology, Otamendi Hospital, Buenos Aires, Argentina.'}, {'ForeName': 'Chotnoparatpat', 'Initials': 'C', 'LastName': 'Paiboon', 'Affiliation': 'Division of Cardiology, Bangkok General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lavarra', 'Affiliation': 'Division of Cardiology, Jilin Cardiovascular Hospital, Changchun, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Division of Cardiology, Taicang 1st People's Hospital, Taicang, China.""}, {'ForeName': 'Kitigon', 'Initials': 'K', 'LastName': 'Vichairuangthum', 'Affiliation': 'Division of Cardiology, Bangplee Hospital, Bangkok, Thailand.'}, {'ForeName': 'Hesong', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Division of Cardiology, Wuhan Tongji Hospital, United Medical University, Wuhan, China.'}, {'ForeName': 'Lianglong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Fujian Medical University Union Hospital, Fujian Institute of Coronary Artery Disease, Fujian Heart Medical Center, Fuzhou, China.'}, {'ForeName': 'Ruiyan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Shanghai Ruijin Hospital, Shanghai Communication University, Shanghai, China.'}, {'ForeName': 'Shiqin', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Division of Cardiology, Xinhua Hospital, Huainan, China.'}, {'ForeName': 'Fengtang', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ""Division of Cardiology, Gansu Provincial People's Hospital, Lanzhou, China.""}, {'ForeName': 'Zening', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Division of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': ""Division of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, China.""}, {'ForeName': 'Likun', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Division of Cardiology, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Shangyu', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Division of Cardiology, Tianjin 4th Central Hospital, Tianjin, China.'}, {'ForeName': 'Xueming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Division of Cardiology, Wuxi 3rd People's Hospital, Wuxi, China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Division of Cardiology, Yixing People's Hospital, Yixing, China.""}, {'ForeName': 'Wei-Hsian', 'Initials': 'WH', 'LastName': 'Yin', 'Affiliation': 'Division of Cardiology, Cheng-Hsin General Hospital, Taipei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Division of Cardiology, Jintan Traditional Chinese Medicine Hospital, Jintan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Division of Cardiology, Liyang Hospital of Traditional Chinese Medicine, Liyang, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Division of Cardiology, Chuzhou People's Hospital, Chuzhou, China.""}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Division of Cardiology, Huaian 2nd People's Hospital, Huaian, China.""}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, Xinyang Central Hospital, Xinyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Lianyungang Traditional Chinese Medicine Hospital, Lianyungang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': 'Division of Cardiology, XuanCheng Central Hospital, Xuancheng, China.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ""Division of Cardiology, Xuyi People's Hospital, Xuyi, China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Division of Cardiology, Jintan People's Hospital, Jintan, China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Division of Cardiology, Huainan People's Hospital, Huainan, China.""}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Division of Cardiology, 2nd People's Hospital, Shandong University, Jinan, China.""}, {'ForeName': 'Qihua', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Changzhou Traditional Chinese Medicine Hospital, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Division of Cardiology, Anqing 1st People's Hospital, Anqing, China.""}, {'ForeName': 'Leng', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Division of Cardiology, Changshu People's Hospital, Changshu, China.""}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Gan', 'Affiliation': 'Division of Cardiology, 17th Metallurgical Hospital, Maanshan, China.'}, {'ForeName': 'Mengyue', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Division of Cardiology, Qingdao Campus of Fuwai Hospital, Qingdao, China.'}, {'ForeName': 'Defeng', 'Initials': 'D', 'LastName': 'Pan', 'Affiliation': ""Division of Cardiology, Xuzhou 2nd People's Hospital, Xuzhou, China.""}, {'ForeName': 'Zhenglu', 'Initials': 'Z', 'LastName': 'Shang', 'Affiliation': ""Division of Cardiology, Wuxi Huishan District People's Hospital, Wuxi, China.""}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Division of Cardiology, Nanjing 81 Hospital, Nanjing, China.'}, {'ForeName': 'Zhizhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Division of Cardiology, Hongze People's Hospital, Huai'an, China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Trinity College, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Ican School of Medicine at Mount Sinai, New York, NY, USA and The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}]",European heart journal,['10.1093/eurheartj/ehaa543']
2050,32584754,Communication Cues and Engagement Behavior: Identifying Advertisement Strategies to Attract Middle-Aged Adults to a Study of the Chronic Disease Self-Management Program.,"INTRODUCTION


Low- and middle-income, middle-aged adults have high rates of disease and death from chronic disease, yet their participation in self-management programs is low. This may be because advertisements for such programs often target elderly, predominantly white, affluent adults. Our study used data from a parent randomized controlled trial to identify theoretically driven advertisement cues to engage low- and middle-income, middle-aged adults in the Chronic Disease Self-Management Program (CDSMP).
METHODS


A framework that combined the Elaboration Likelihood Model and Protection Motivation Theory was used to guide χ 2  and regression analyses to assess relationships between advertisement cue preferences and 5 stages of cognitive engagement (cue processing, cognitive appraisal of the advertised study, motivation to enroll) and behavioral engagement of study participants (enrollment and program participation).
RESULTS


One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing.
CONCLUSION


These results can inform CDSMP recruitment efforts to better engage low- and middle-income, middle-aged adults in an effort to mitigate the disproportionate burden of chronic disease in this population.",2020,"RESULTS


One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing.
","['middle-aged adults in the Chronic Disease Self-Management Program (CDSMP', 'Attract Middle-Aged Adults']",[],[],"[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],[],,0.030059,"RESULTS


One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing.
","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Horrell', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, North Carolina.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Knafl', 'Affiliation': 'University of North Carolina at Chapel Hill, School of Nursing, Chapel Hill, North Carolina.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Brady', 'Affiliation': 'Clarity Consulting and Communications, Atlanta, Georgia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Lazard', 'Affiliation': 'University of North Carolina at Chapel Hill, Hussman School of Journalism and Media, Chapel Hill, North Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linnan', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, North Carolina.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kneipp', 'Affiliation': 'University of North Carolina at Chapel Hill, School of Nursing, Chapel Hill, North Carolina.'}]",Preventing chronic disease,['10.5888/pcd17.190413']
2051,32590137,Bone turnover markers in children living with HIV remaining on ritonavir-boosted lopinavir or switching to efavirenz.,"INTRODUCTION


We previously found lower bone mass but similar bone turnover in pre-pubertal children living with HIV (CLWH) on a ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy regimen 2 years after switch. Here, we evaluate if bone turnover differed between the groups close to the time of switch.
METHODS


Samples from 108 children remaining on LPV/r and 104 children switched to efavirenz were available for analysis 8 weeks post-randomization. Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin were measured. Markers of immune activation were also measured, including IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP).
RESULTS


Eight weeks post-randomization, we did not detect differences in CTx (1.42 vs. 1.44 ng/mL, p = 0.85) or P1NP concentrations (622 vs. 513 ng/mL, p = 0.68) between treatment groups. At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP. Osteocalcin (ng/mL) was higher in the LPV/r than efavirenz group both at 8 weeks (88.6 vs. 67.3, p = 0.001) and 2 years (67.6 vs. 49.8, p = 0.001).
CONCLUSIONS


Overall, we failed to detect difference in bone turnover by P1NP and CTx in virologically-suppressed CLWH on different regimens at a time point close to the switch. We did observe higher levels of total osteocalcin in children remaining on LPV/r compared to children switched to efavirenz. Future studies should focus on uncovering the mechanism and determining whether perturbation in undercarboxylated osteocalcin could explain some of the bone side effects noted with protease inhibitors.",2020,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","['children living with HIV remaining on ritonavir-boosted lopinavir or switching to', 'Samples from 108 children remaining on LPV/r and 104 children switched to', 'pre-pubertal children living with HIV (CLWH) on a']","['efavirenz', 'ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy']","['IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP', 'Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin', 'levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP', 'Osteocalcin', 'bone turnover by P1NP and CTx', 'total osteocalcin', 'CTx', 'Bone turnover markers', 'bone turnover', 'P1NP concentrations', 'Markers of immune activation']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.0664262,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shiau', 'Affiliation': 'Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Yin', 'Affiliation': 'Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Strehlau', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Coovadia', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA. Electronic address: sma2@columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115500']
2052,32593123,Quality of life changes in response to yoga therapy in patients with schizophrenia: Reanalysis of Three randomized controlled trials.,,2020,,['patients with schizophrenia'],['yoga therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.0595902,,"[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Ikai-Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, M5S 2W6, Toronto, ON, Canada. Electronic address: sako0609@gmail.com.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Kimel Family Translational Imaging-Genetics Laboratory, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Geriatric Mental Health Program, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102250']
2053,32593717,Caring for older veterans with chronic low back pain using a geriatric syndrome approach: Rationale and methods for the aging back clinics (ABC) trial.,"The purpose of the ongoing trial is to improve care of older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6 months on ≥ half the days). Current CLBP care is limited by being either overly spine-focused or non-specifically prescribed and both approaches frequently lead to suboptimal reduction in pain and improvement in function. Through prior studies we have laid the foundation for a patient-centered approach to care for older Veterans with CLBP in which the spine is a source of vulnerability but not the sole treatment target. The approach considers CLBP a geriatric syndrome, a final common pathway for the expression of multiple contributors rather than a disease of the spine. We describe here the rationale and design of a randomized controlled trial to test the efficacy of an older Veteran-centered approach to CLBP care in ""Aging Back Clinics (ABCs)"" compared with Usual Care (UC). Three hundred thirty Veterans age 65-89 with CLBP will be randomized to ABCs or UC and followed for 12 months after randomization. We will assess the impact of ABCs on our primary outcome of pain-associated disability with the Oswestry Disability Index at 6 and 12 months, and secondary outcomes of pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization. If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.",2020,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","['Three hundred thirty Veterans age 65-89 with CLBP', 'older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6\u202fmonths on ≥ half the days', 'older veterans with chronic low back pain using a geriatric syndrome approach', 'older adults with CLBP']","['ABCs or UC', 'older Veteran-centered approach to CLBP care', 'Usual Care (UC']","['pain-associated disability with the Oswestry Disability Index', 'pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",330.0,0.0631505,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","[{'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America. Electronic address: debra.weiner@va.gov.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gentili', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Meika A', 'Initials': 'MA', 'LastName': 'Fang', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Garay', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Thiru', 'Initials': 'T', 'LastName': 'Annaswamy', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Castle', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Joseph', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lawson', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Una E', 'Initials': 'UE', 'LastName': 'Makris', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Rossi', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'University of Alabama, Tuscaloosa, AL, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Clemens', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Newman', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America; University of Pittsburgh Graduate School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106077']
2054,32593750,Effect of acute caffeine intake on hit accuracy and reaction time in professional e-sports players.,"Caffeine is considered a cognitive enhancer at low to moderate doses because it improves alertness, vigilance, attention, and reaction time. However, no previous investigation has assessed the effect of acute caffeine intake on e-sports-specific performance. The aim of this investigation was to determine the effect of the ingestion of 3 mg per kg of body mass on simple reaction time in a color test and on hit accuracy and reaction time during a first-person shooting game. Fifteen professional e-gamers (age= 22 ± 3 years) participated in a double-blind, cross-over, randomized experimental trial. In two trials 3 days apart, participants either ingested a placebo (cellulose) or 3 mg/kg of caffeine in an opaque and unidentifiable capsule. After a 45-min wait for substance absorption, participants performed 5 attempts at a simple reaction time test and completed a first-person shooting game that included 3 attempts at a 2-min game with 60 fixed targets (180 targets in total). Reaction times (in both tests) and accuracy in hitting the targets (only in the shooting game) were measured. In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01). In summary, the acute ingestion of 3 mg/kg of caffeine reduced the time taken to react to a simple stimulus, decreased the time taken to hit a fixed target and improved accuracy in hitting the target in a first-person shooting game in professional e-gamers. Thus, the caffeine ingestion (3 mg/kg) might be considered as an ergogenic aid for e-sports gamers based on its effect to enhance hit accuracy and time.",2020,"In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01).","['Fifteen professional e-gamers (age= 22 ± 3 years) participated in a double-blind, cross-over, randomized experimental trial', 'professional e-sports players']","['acute caffeine intake', 'caffeine ingestion', 'caffeine', 'placebo (cellulose) or 3 mg/kg of caffeine', 'Caffeine', 'placebo, caffeine']","['enhanced hit accuracy', 'time taken to hit a fixed target and improved accuracy', 'alertness, vigilance, attention, and reaction time', 'simple reaction time', 'Reaction times', 'hit accuracy and reaction time', 'mean time taken to hit the targets']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0879569,"In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01).","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sainz', 'Affiliation': 'Team Queso, e-Gamers Club. Madrid, Spain. Electronic address: nachosainz10@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Madrid, Spain. Electronic address: daniel.collado@urjc.es.'}, {'ForeName': 'Juan Del', 'Initials': 'JD', 'LastName': 'Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Madrid, Spain. Electronic address: juan.delcoso@urjc.es.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113031']
2055,32598735,"[Risk - adapted intensive induction therapy, autologous stem cell transplantation, and rituximab maintenance allow to reach a high 7-year survival rate in patients with mantle cell lymphoma].","Mantle cell lymphoma (MCL) is aggressive B-cell neoplasm diagnosed predominantly among older men. R-CHOP-like regimens allow to achieve high response rate, but the overall survival (OS) are disappointingly short - 3-4 years. An addition of high - dose cytarabine to the upfront therapy and autoSCT significantly improved outcomes but remain feasible largely for medically fit patients. Based on the activity and good tolerance of gemcitabine - oxaliplatin schemes in relapsed and refractory MCL patients, we developed an alternative first - line course for patients who are not eligible for R-HD-MTX-AraC.
AIM


Assess toxicity and efficacy of R-DA-EPOCH/ R-HD-MTX-AraC and R-DA-EPOCH/R-GIDIOX schemes, autoSCT and R-maintenance in untreated MCL patients.
MATERIALS AND METHODS


47 untreated MCL patients from 6 centers were enrolled in prospective study between April 2008 and September 2013. All patients have stage II-V; ECOG 0-3; median age 55 years (29-64); Male/Female 76%/24%. MIPIb: 28% low, 33% intermediate and 39% high risk. Following 1st R-EPOCH patients were assigned to receive either R-DA-EPOCH/ R-HD-MTX-AraC or R-DA-EPOCH/ R-GIDIOX regimen. In the absence of renal failure, hematological toxicity grade 4 more than 3 days and severe infections patients received R-HD-MTX-AraC scheme (R 375 mg/m2 Day 0, Methotrexate 1000 mg/m2/24 hours Day 1, AraC 3000 mg/m2 q 12 hrs Days 2-3). Patients who had at least one of these complications received R-GIDIOX scheme (R 375 mg/m2 day 0, gemcitabine 800 mg/m2 days 1 and 4, ifosfamide 1000 mg/m2 days 1-5, dexamethasone 10 mg/m2 IV days 1-5, irinotecan 100 mg/m2 day 3, oxaliplatin 120 mg/m2 day 2). Subsequently these courses were alternating with R-DA-EPOCH in each arm of the protocol. Depending on the time of achieving CR patients received 6 or 8 courses, unless they progressed on therapy. Those patients who achieved PR/CR/CRu underwent autoSCT (BEAM-R). Post - transplant R-maintenance was administered for 3 years (R - 375 mg/m2 every 3 months).
RESULTS


29/47 patients were treated on R-HD-MTX-AraC arm (median 50 years; MIPIb: 35.7% low, 28.6% intermediate, 35.7% high risk) and 18/47 patients were on R-GIDIOX arm (median 60 years; MIPIb: 16.7% low, 38.9% intermediate, 44.4% high risk). In R-HD-MTX-AraC arm CR rate was 96.5%. In R-GIDIOX arm OR and CR rates were 94.4% and 77.7% respectively. Main hematological toxicity of R-GIDIOX was leukopenia gr. 4 occurred in 74.1%. With median follow - up of 76 months, the estimated 7-years OS and EFS in R-HD-MTX-AraC arm are 76% and 57% respectively. In R-GIDIOX arm the estimated 7-years OS and EFS are 59% and 44%, respectively. There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms.
CONCLUSIONS


The use of a risk - adapted strategy allowed 95.7% of patients achieve PR/CR/CRu, performed autoSCT and begun R-maintenance therapy with rituximab. None of the patients needed a premature discontinuation of therapy because of unacceptable toxicity. The performance of autoSCT and R-maintenance apparently allowed to partially offset differences in the intensity of induction therapy and to maintain comparable results of therapy in both induction arms.",2019,"There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms.
","['patients with mantle cell lymphoma', '47 untreated MCL patients from 6 centers were enrolled in prospective study between April 2008 and September 2013', 'All patients have stage II-V; ECOG 0-3; median age 55 years (29-64); Male/Female 76%/24', 'relapsed and refractory MCL patients']","['cytarabine', 'gemcitabine - oxaliplatin', 'Risk - adapted intensive induction therapy, autologous stem cell transplantation, and rituximab maintenance', 'ifosfamide 1000 mg/m2 days 1-5, dexamethasone 10 mg/m2 IV days 1-5, irinotecan 100 mg/m2 day 3, oxaliplatin', 'R-DA-EPOCH/ R-HD-MTX-AraC or R-DA-EPOCH/ R-GIDIOX regimen', 'gemcitabine', 'rituximab', 'Methotrexate']","['CR rates', 'EFS', 'CR rate', '7-year survival rate', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855138', 'cui_str': 'Mantle cell lymphoma refractory'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4238558', 'cui_str': 'Ifosfamide 1000 MG [Ifex]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",47.0,0.0466639,"There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms.
","[{'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Vorobyev', 'Affiliation': 'Botkin Moscow City Clinical Hospital.'}, {'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Gemdzhian', 'Affiliation': 'National Research Center for Hematology.'}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Dubrovin', 'Affiliation': 'Botkin Moscow City Clinical Hospital.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Nesterova', 'Affiliation': 'National Research Center for Hematology.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Kaplanov', 'Affiliation': 'Volgograd Regional Clinical Oncologic Dispensary.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Volodicheva', 'Affiliation': 'Tula Region Hospital.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Zherebtsova', 'Affiliation': 'Botkin Moscow City Clinical Hospital.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Kravchenko', 'Affiliation': 'National Research Center for Hematology.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.07.000322']
2056,32603956,Leptin mediates improvements in cognitive function following treatment with infliximab in adults with bipolar depression.,"A potential role for leptin in the pathophysiology of bipolar disorder (BD) has been proposed. We recently investigated the effects of the tumor necrosis factor-alpha (TNF-α) antagonist infliximab in individuals with bipolar depression. Leptin is known to interact with the TNF-α system. Herein, we aimed to explore infliximab's effects on leptin and its relationship with brain structure and function. Sixty adults with bipolar depression were enrolled in this randomized, double-blind, 12-week clinical trial of adjunctive infliximab (n = 29) and saline control (n = 31), which were administered intravenously at weeks 0, 2, and 6. Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR) 1 and 2 were assessed at weeks 0, 2, 6, and 12. We observed a significant decrease in leptin levels in infliximab-treated patients, relative to placebo. Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels. Changes in sTNR2 levels at week 6 significantly determined changes in leptin at week 12 in infliximab-, but not placebo-treated participants. Improvements in verbal memory and increases in global cortical volume were associated with reduction in leptin levels in the treatment group. Mediation analysis indicated that cognitive improvement in infliximab-treated patients was mediated by reductions in leptin levels, which in its turn were determined by decreases in sTNR2 levels. In conclusion, infliximab treatment reduced plasma leptin levels in individuals with BD, through modulation of sTNFR2. Decreases in leptin signaling were associated with an increase in global cortical volume and better performance in a verbal memory task.",2020,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","['Sixty adults with bipolar depression', 'individuals with BD', 'adults with bipolar depression', 'individuals with bipolar depression']","['Leptin', 'saline control', 'adjunctive infliximab', 'infliximab', 'Infliximab', 'tumor necrosis factor-alpha (TNF-α) antagonist infliximab', 'placebo']","['leptin', 'cognitive improvement', 'global cortical volume and better performance in a verbal memory task', 'cognitive function', 'Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR', 'verbal memory', 'plasma leptin levels', 'global cortical volume', 'leptin signaling', 'leptin levels', 'TNF-α and sTNFR2', 'sTNR2 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.149116,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: rodrigo.mansur@uhn.ca.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; University of Ottawa, Department of Psychiatry, Ottawa, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Nasri', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Rashidian', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Kingston General Hospital, Providence Care Hospital, Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104779']
2057,32603994,A randomized-controlled examination of the effect of cognitive reappraisal instruction on maternal accommodation of child anxiety symptoms.,"Parental accommodation plays a key role in the maintenance of child anxiety, yet much of the research to date has been correlational, making it difficult to draw conclusions about underlying mechanisms. Given preliminary evidence that parental beliefs play a role in parental accommodation, the present study sought to experimentally reduce accommodation by targeting parental attitudes about child anxiety. Mothers of children ages 4-9 (N = 47) were randomly assigned to either receive brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON). At pre- and post-intervention mothers were presented with bogus information that their child was experiencing varying levels of distress while completing a task in a nearby room. Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress were measured pre- and post-intervention. EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers. EXP and CON mothers showed similar changes in negative affect. Findings from this study provide preliminary experimental evidence that targeting maternal beliefs about child anxiety can result in changes in maternal distress and behavior following exposure to child distress. Implications for prevention and treatment are discussed.",2020,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.",['Mothers of children ages 4-9 (N = 47'],"['cognitive reappraisal instruction', 'brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON']","['distress and perceived likelihood of accommodation', 'Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress', 'maternal accommodation of child anxiety symptoms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",47.0,0.050831,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Department of Psychology, Florida International University, 11200 SW 8th Street, Miami, FL, 33199, United States.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102260']
2058,32613281,Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma.,"The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study (NCT02181413) demonstrated improved progression-free survival with ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT) in multiple myeloma patients. We report additional safety data from TOURMALINE-MM3 to inform adverse event (AE) management recommendations. Patients were randomized 3:2 to receive ixazomib (n = 395) or placebo (n = 261) on days 1, 8, and 15 of 28-day cycles for ~ 2 years or until progressive disease/toxicity. The initial 3-mg ixazomib dose was escalated to 4 mg in cycle 5, if tolerated in cycles 1-4. Safety was a secondary endpoint assessed in all treated patients; AEs were graded using Common Terminology Criteria for AEs v4.03. The rate of grade ≥ 3 AEs was higher in the ixazomib arm (19%) than in the placebo arm (5%), but the rate of discontinuation due to AEs was similar (7% vs. 5%). For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%. However, the majority of events were low-grade, manageable with supportive therapy or dose reduction, and reversible, and did not result in discontinuation. There was no evidence of cumulative, long-term, or late-onset toxicity with ixazomib maintenance. Ixazomib is an efficacious and tolerable option for post-ASCT maintenance. AEs associated with ixazomib maintenance can be managed in the context of routine post-ASCT supportive care due to the limited additional toxicity. ClinicalTrials.gov NCT02181413.",2020,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.",['multiple myeloma patients'],"['ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT', 'Ixazomib', 'ixazomib', 'placebo']","['diarrhea', 'rate of grade ≥\u20093 AEs', 'progression-free survival', 'thrombocytopenia', 'rate of discontinuation due to AEs', 'vomiting', 'cumulative, long-term, or late-onset toxicity']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0639010', 'cui_str': '3-(2-aminoethyl)-8-(3-(4-fluorobenzoyl)propyl)-4-oxo-1-phenyl-1,3,8-triazaspiro(4.5)decan-4-one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.566705,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK. Martin.Kaiser@icr.ac.uk.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksaç', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gulbrandsen', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'de Arriba de la Fuente', 'Affiliation': 'Servicio de Hematología y Oncología Médica, Hospital Universitario Morales Meseguer y Centro Regional de Hemodonación, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Department of Hematology, University Hospital of Salamanca, CIC, IBM CC, Salamanca, Spain.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Czorniak', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Annals of hematology,['10.1007/s00277-020-04149-5']
2059,32618385,"The effect of referral to an open-group behavioural weight-management programme on the relative risk of normoglycaemia, non-diabetic hyperglycaemia and type 2 diabetes: Secondary analysis of the WRAP trial.","AIM


To examine the impact of open-group behavioural weight-management programmes on the risk of diabetes among those with a body mass index (BMI) of ≥28 kg/m 2  and those with non-diabetic hyperglycaemia (NDH).
METHODS


This was a secondary analysis of data from the WRAP trial, in which participants (N = 1267; aged ≥18 years, BMI ≥ 28 kg/m 2  ) were randomized to brief intervention (BI; self-help booklet), a weight-management programme (WW; formerly Weight Watchers) for 12 weeks, or WW for 52 weeks. We used multinomial logistic regression to examine the effect of intervention group on the risk of hyperglycaemia and diabetes at 12 months in all participants with glycaemic status at both time points (N = 480; 38%) and those with NDH at baseline (N = 387; 31%). We used mixed effects models and linear fixed effects models to examine the effect of intervention group on body weight and HbA1c at 12 months in people with NDH.
RESULTS


There was a 61% relative reduction in the risk of NDH at the 12-month follow-up (12 weeks vs. BI: relative risk ratio [RRR] = 0.39 [95% CI 0.18, 0.87], P = .021; 52 weeks vs. BI: RRR = 0.38 [95% CI 0.17, 0.86], P = .020). For intervention effects on the risk of diabetes, confidence intervals were wide and overlapped 1 [12 weeks vs. BI: RRR = 0.49 [95% CI 0.12, 1.96], P = .312; 52 weeks vs. BI: RRR = 0.40 [95% CI 0.10, 1.63], P = .199). Participants with hyperglycaemia at baseline in the weight-management programme were more probable to have normoglycaemia at the 12-month follow-up [12-week programme vs. BI: RRR = 3.57 [95% CI 1.24, 10.29], P = .019; 52-week programme vs. BI: RRR = 4.14 [95% CI 1.42, 12.12], P = .009).
CONCLUSIONS


Open-group behavioural weight-management programmes can help to prevent the development of NDH in people with overweight and obesity and to normalize glycaemia in people with NDH.",2020,There was a 61% relative reduction in risk of NDH at 12 month follow up,"['participants with glycaemic status at both time points (N\xa0=\xa0480; 38%) and those with NDH at baseline', 'people with overweight and obesity and to normalise glycaemia in people with NDH', 'diabetes risk among i', 'participants (N\xa0=\xa01267; ≥18\u2009years, BMI ≥28\u2009kg/m 2  ', 'Participants with hyperglycaemia at baseline in the weight management programme', 'people with NDH']","['open-group behavioural weight management programmes', 'brief intervention (BI; self-help booklet), a weight management programme (WW, formerly Weight Watchers', 'open-group behavioural weight management programme']","['risk of NDH', 'risk of hyperglycaemia and diabetes', 'risk of diabetes, confidence intervals', 'relative risk of normoglycaemia, non-diabetic hyperglycaemia', 'body weight and HbA 1c', 'normoglycaemia']","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1857775', 'cui_str': 'Diabetes Mellitus, Neonatal, with Congenital Hypothyroidism'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1857775', 'cui_str': 'Diabetes Mellitus, Neonatal, with Congenital Hypothyroidism'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0850671', 'cui_str': 'Non-diabetic hyperglycemia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",,0.115204,There was a 61% relative reduction in risk of NDH at 12 month follow up,"[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Graham M', 'Initials': 'GM', 'LastName': 'Wheeler', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Boyland', 'Affiliation': 'School of Psychology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'School of Psychology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14123']
2060,32619609,"Evaluating the structural effects of intra-articular sprifermin on cartilage and non-cartilaginous tissue alterations, based on sqMRI assessment over 2 years.","OBJECTIVE


Sprifermin (recombinant human fibroblast growth factor-18), a potential disease-modifying osteoarthritis (OA) drug, demonstrated dose-dependent effects on femorotibial cartilage thickness (by quantitative magnetic resonance imaging [MRI]) in the phase II FORWARD study. This post-hoc analysis evaluated the potential effects of sprifermin on several articular structures in the whole joint over 24 months using semi-quantitative MRI assessment.
DESIGN


Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee were randomized (1:1:1:1:1) to receive three double-blinded, once-weekly, intra-articular injections of sprifermin 30 μg or 100 μg or placebo every 6 (q6mo) or 12 months. 1.5- or 3 T MRIs were read using the Whole-Organ Magnetic Resonance Imaging Score (WORMS) system at baseline and 24 months. Change from baseline at 24 months on compartment and/or whole knee level was assessed for cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches. Menisci, Hoffa-synovitis, and effusion-synovitis were also evaluated for worsening.
RESULTS


549 patients were included. Dose-dependent treatment effects from baseline to 24 months were observed on cartilage morphology (sprifermin 100 μg q6mo vs placebo; mean DSM (95% confidence interval [CI]) -0.6 (-1.5, 0.2); less cartilage worsening) in the entire knee and BMLs sprifermin 100 μg q6mo vs placebo; mean DSM (95% CI) -0.2 (-0.5, 0.1) in the patellofemoral compartment. No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
CONCLUSIONS


Positive effects associated with sprifermin were observed for cartilage morphology changes, and BML improvement. There were no meaningful negative or positive effects associated with sprifermin in the other joint tissues examined.",2020,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
","['549 patients were included', 'Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee']","['Sprifermin (recombinant human fibroblast growth factor-18', 'sprifermin 30 μg or 100 μg or placebo', 'placebo']","['Menisci, Hoffa-synovitis, and effusion-synovitis', 'cartilage morphology', 'osteophytes, menisci, Hoffa-synovitis or effusion-synovitis', 'cartilage morphology changes, and BML improvement', 'femorotibial cartilage thickness', 'cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C1432638', 'cui_str': 'fibroblast growth factor 18, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0224498', 'cui_str': 'Meniscus structure of joint'}, {'cui': 'C0268203', 'cui_str': 'Liposynovitis prepatellaris'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",549.0,0.160466,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
","[{'ForeName': 'F W', 'Initials': 'FW', 'LastName': 'Roemer', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; University of Erlangen-Nuremberg, Erlangen, Germany. Electronic address: froemer@bu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kraines', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA, a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aydemir', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA, a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wax', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA, a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Crema', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; Institute of Sports Imaging, French National Institute of Sports, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; Department of Radiology, VA Boston Healthcare System, West Roxbury, MA, 02132, USA.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.05.015']
2061,32619868,Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults.,"Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial (""X:BOT"") comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.",2020,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","['black adults', '73 Black participants with OUD (81% male, mean age 39.05, SD\xa0=\xa011.80) participating']","['extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX', 'naltrexone', 'buprenorphine-naloxone']",['relapse rates'],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",73.0,0.101327,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Haeny', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 34 Park St., New Haven, CT 06511, United States. Electronic address: angela.haeny@yale.edu.'}, {'ForeName': 'LaTrice', 'Initials': 'L', 'LastName': 'Montgomery', 'Affiliation': 'University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience, 3131 Harvey Avenue., Cincinnati, OH 45229, United States.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, Department of Psychology, 2600 Clifton Ave., Cincinnati, OH 45221, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, One Park Ave., New York, NY 10016, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106514']
2062,32621736,Effect of Oral Glucose Water Administration 1 Hour Preoperatively in Children with Cyanotic Congenital Heart Disease: A Randomized Controlled Trial.,"BACKGROUND Guidelines recommend a clear liquid fasting time of 2 h before surgery, which is often exceeded, leading to adverse reactions (ARs) such as discomfort, thirst, and dehydration. We assessed the gastric contents and ARs after oral glucose water administration 1 h prior to surgery in children with cyanotic congenital heart disease (CCHD). MATERIAL AND METHODS This was a non-inferiority randomized controlled trial of children with CCHD enrolled at the Fujian Medical University Union Hospital from 09/2014 to 05/2017 and randomized to receive oral glucose water (10 g of glucose in 100 ml of warm water, 5 ml/kg) 2 h (2-h group, n=174) or 1 h (1-h group, n=170) before surgery. The primary endpoint was gastric volume. Secondary endpoints included pH of gastric content, preoperative blood glucose, and risk factors for aspiration pneumonia. Pre- and intraoperative ARs were recorded. RESULTS The 1-h group showed smaller gastric content volumes (0.34±0.35 (95% CI: 0.29-0.39) vs. 0.43±0.33 (95% CI: 0.38-0.48) ml/kg, t=2.55, P<0.05) and higher blood glucose (6.21±0.78 (95% CI: 6.09-6.33) vs. 5.59±1.11 (95% CI: 5.43-5.76) mmol/L, t=-5.91, P<0.001). The 95% confidence interval of the volume difference between the 2 groups was 0.017-0.163, the upper limit value was 0.163 <delta=0.2 (P<0.01). The non-inferiority hypothesis was correct. The 1-h group showed lower incidence of crying, thirst and hypoxia (all P<0.05 vs. 2-h group). There were no differences in ARs between the 2 groups. CONCLUSIONS A 1-h fast prior to surgery was not inferior to a 2-h fast in terms of gastric residuals and ARs in pediatric patients with CCHD.",2020,"The 1-h group showed lower incidence of crying, thirst and hypoxia (all P<0.05 vs. 2-h group).","['Children with Cyanotic Congenital Heart Disease', 'children with cyanotic congenital heart disease (CCHD', 'children with CCHD enrolled at the Fujian Medical University Union Hospital from 09/2014 to 05/2017 and randomized to receive', 'pediatric patients with CCHD']","['oral glucose water (10 g of glucose', 'oral glucose water administration 1 h prior to surgery', 'Oral Glucose Water']","['Pre- and intraoperative ARs', 'higher blood glucose', 'gastric volume', 'lower incidence of crying, thirst and hypoxia', 'pH of gastric content, preoperative blood glucose, and risk factors for aspiration pneumonia', 'gastric contents and ARs', 'smaller gastric content volumes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0265808', 'cui_str': 'Cyanotic congenital heart disease'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0038352', 'cui_str': 'Gastric contents'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",,0.289219,"The 1-h group showed lower incidence of crying, thirst and hypoxia (all P<0.05 vs. 2-h group).","[{'ForeName': 'Xizhen', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Haoruo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Fujian Medical University Union Clinical Medicine College, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Yanjuan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Liangwan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Sailan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Fujian Medical University, Fuzhou, Fujian, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922642']
2063,32590251,The treatment of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation.,"OBJECTIVES


To compare the advantages and disadvantages of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO) with those of semilunar ganglion RF thermocoagulation (GRF) under local anesthesia, for exploring a new and available surgical method for patients with V2 + V3 idiopathic trigeminal neuralgia.
PATIENTS AND METHODS


102 patients with V2 + V3 idiopathic trigeminal neuralgia were enrolled in this prospective randomized controlled clinical trial, and they were divided into the PRF and GRF group randomly (n = 51 in both groups). The outcome of pain relief was assessed using the Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed). Recurrence was defined as a relapse to a previous lower level after attainment of any higher level of pain relief. The immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications were observed and recorded.
RESULTS


Their basic conditions (age, gender ratio, side of pain, and disease duration) were similar. Furthermore, we found that the 2-year postoperative effective rate between them had no significant difference. By comparing the two groups, PRF group had the better immediate effective rate of the V2 branch and no severe complications such as corneal ulcer, however, GRF group had lower 2-year postoperative recurrence rate of the V3 branch and fewer facial swelling.
CONCLUSION


The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.",2020,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","['patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia', '102 patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia']","['PRF and GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation', 'semilunar ganglion RF thermocoagulation (GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO']","['facial swelling', 'pain relief', 'Recurrence', 'immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications', '2-year postoperative effective rate', 'immediate effective rate of the V2 branch and no severe complications such as corneal ulcer', 'Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed', '2-year postoperative recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}]","[{'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0017067', 'cui_str': 'Structure of nervous system ganglion'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}, {'cui': 'C0016521', 'cui_str': 'Structure of foramen ovale of heart'}, {'cui': 'C0040995', 'cui_str': 'Structure of trigeminal ganglion'}]","[{'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010043', 'cui_str': 'Corneal ulcer'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",102.0,0.0255936,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': ""Department of Pain Clinic, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Changxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Pain Clinic, Subei People's Hospital, Yangzhou, Jiangsu, 225002, People's Republic of China. Electronic address: 1714452550@qq.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China. Electronic address: zy830226@163.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106025']
2064,32592830,Cluster-sets resistance training induce similar functional and strength improvements than the traditional method in postmenopausal and elderly women.,"OBJECTIVE


The aim of this study was to compare the effects of 12 weeks of traditional resistance training (TRT) or resistance training using Cluster-set (CS) on functional performance and physical fitness of postmenopausal and elderly women.
METHODS


Participants (61.1 ± 4.9 years, body mass 64.5 ± 1.8 kg, height 155.7 ± 4.7 cm) were randomized to TRT (n = 35) or CS (n = 31). Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests were performed before and after 12 weeks of training. The difference between protocols was the structure of rest intervals. The TRT group performed 120 s of rest between sets of 8 repetitions, while the CS performed 30 s of rest after every 2 repetitions. Two-way ANOVA with repeated measures was applied for each variable and, when needed, the Bonferroni post hoc was used. Statistical significance was set at p < 0.05.
RESULTS


No group by time interaction was found for any variable. Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001).
CONCLUSION


Considering that both CS and TRT methods were equally effective to improve the physical fitness and functionality of elderly women, the decision of which protocol to use should be based on individual preferences and practical aspects.",2020,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001).
","['Participants (61.1\u202f±\u202f4.9\u202fyears, body mass 64.5\u202f±\u202f1.8\u202fkg, height 155.7\u202f±\u202f4.7\u202fcm', 'postmenopausal and elderly women', 'elderly women']","['traditional resistance training (TRT) or resistance training using Cluster-set (CS', 'CS', 'Cluster-sets resistance training', 'TRT']","['Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests', 'countermovement jump', '1 repetition maximum (RM) bench press', '1RM leg press', 'standing long jump', 'plank time', 'functional performance and physical fitness', 'squat jump']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",,0.024454,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001).
","[{'ForeName': 'Rayra Khalinka Neves', 'Initials': 'RKN', 'LastName': 'Dias', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Eduardo Macedo', 'Initials': 'EM', 'LastName': 'Penna', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil; Programa de Pós Graduação em Ciências do Movimento Humano, Universidade Federal do Pará.'}, {'ForeName': 'Adria Samara Negrão', 'Initials': 'ASN', 'LastName': 'Noronha', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Antenor Barbosa Calandrini', 'Initials': 'ABC', 'LastName': 'de Azevedo', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiânia, GO, Brasil.'}, {'ForeName': 'Paulo Viana', 'Initials': 'PV', 'LastName': 'Gentil', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiânia, GO, Brasil.'}, {'ForeName': 'Victor Silveira', 'Initials': 'VS', 'LastName': 'Coswig', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil; Programa de Pós Graduação em Ciências do Movimento Humano, Universidade Federal do Pará. Electronic address: vcoswig@ufpa.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111011']
2065,32593547,Pegvaliase for the treatment of phenylketonuria: Results of the phase 2 dose-finding studies with long-term follow-up.,"BACKGROUND


Phenylketonuria (PKU) is characterized by a deficiency in phenylalanine hydroxylase (PAH) that may lead to elevated blood phenylalanine (Phe) and significant neurocognitive and neuropsychological comorbidities. Pegvaliase (PALYNZIQ®, BioMarin Pharmaceutical Inc.) is a PEGylated recombinant Anabaena variabilis phenylalanine ammonia lyase (PAL), which converts Phe to trans-cinnamic acid and ammonia, and was approved in May 2018 in the United States and in May 2019 in the European Union for decreasing blood Phe levels in adults with PKU with blood Phe levels >600 μmol/L. The efficacy and safety of pegvaliase was assessed in two phase 2 dose-finding studies in adults with PKU (PAL-002, NCT00925054, and PAL-004, NCT01212744). Participants completing these studies could enroll in a long-term extension study (PAL-003, NCT00924703).
METHODS


Participants in PAL-002 received pegvaliase 0.001, 0.003, 0.01, 0.03, or 0.1 mg/kg weekly for 8 weeks, then continued treatment for a further 8 weeks with dose and/or frequency adjusted to achieve blood Phe concentrations of 60 to 600 μmol/L. Participants in PAL-004 received pegvaliase 0.001 to 0.4 mg/kg 5 days/week for 13 weeks, with modifications made to the starting dose in response to safety and/or efficacy, followed by 3 additional weeks of follow-up assessments. The maximum allowable daily dose in both studies was 1.0 mg/kg/day (5.0 mg/kg/week). Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703).
RESULTS


Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed PAL-004. Mean blood Phe at baseline was 1311.0 (standard deviation [SD] 354) μmol/L in PAL-002 and 1482.1 (SD 363.5) μmol/L in PAL-004. Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13). In PAL-004, mean blood Phe dropped from baseline by 929.1 μmol/L (SD 691.1) by Week 2; subsequent to dose modifications and interruptions, this early decrease in mean Phe level was not sustained. With increased pegvaliase dose and duration in PAL-003, mean blood Phe levels steadily decreased from baseline, with mean reductions by Week 120 of 68.8% (SD 44.2%) in PAL-002 participants and 75.9% (SD 32.4%) in PAL-004 participants. All participants in PAL-002 and PAL-004 reported ≥1 adverse event (AE), with higher exposure-adjusted event rates in PAL-004. The majority of AEs were mild (87.2% in PAL-002, 86.7% in PAL-004) or moderate (12.4% in PAL-002, 13.3% in PAL-004). The most commonly reported AEs in PAL-002 were injection site reaction (50.0% of participants), headache (42.1%), injection site erythema (36.8%), nausea (34.2%), and arthralgia (29.0%), and in PAL-004 were arthralgia (75.0%), headache (62.5%), dizziness (56.3%), injection site erythema (56.3%), and injection site reaction (50.0%).
CONCLUSIONS


In two phase 2 dose-finding studies, pegvaliase did not lead to substantial blood Phe reductions. Higher and more frequent pegvaliase dosing in PAL-004 led to a substantial initial drop in blood Phe, but an increase in the number of hypersensitivity AEs and dose reductions or interruptions. With increased dose and duration of treatment in PAL-003, mean blood Phe reduction was substantial and sustained, and the frequency of hypersensitivity AEs decreased and stabilized. Together, these studies led to the development of an induction-titration-maintenance regimen that has been approved for pegvaliase, with patients starting at a low weekly dose that gradually increases in dose and frequency until they achieve a standard non-weight-based daily maintenance dose. This regimen has been tested in a third phase 2 study, as well as in two successful phase 3 studies of pegvaliase.",2020,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"['Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed', 'adults with PKU with blood Phe levels', 'Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703']",['PAL-004'],"['headache', 'dizziness', 'efficacy and safety of pegvaliase', 'frequency of hypersensitivity AEs', 'mean blood Phe', 'injection site reaction', 'pegvaliase dose and duration in PAL-003, mean blood Phe levels', 'nausea', 'arthralgia', 'injection site erythema', 'adverse event (AE', 'Mean blood Phe']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519229', 'cui_str': 'pegvaliase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0852625', 'cui_str': 'Injection site erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.118836,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"[{'ForeName': 'Barbara K', 'Initials': 'BK', 'LastName': 'Burton', 'Affiliation': ""Department of Pediatrics, Division of Genetics, Birth Defects & Metabolism, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611, United States of America. Electronic address: BBurton@luriechildrens.org.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Longo', 'Affiliation': 'Department of Pediatrics, Division of Medical Genetics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, United States of America. Electronic address: Nicola.Longo@hsc.utah.edu.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""Department of Pediatrics, Division of Medical Genetics, University of Pittsburgh and Children's Hospital of Pittsburgh, 4401 Penn Ave, Pittsburgh, PA 15224, United States of America. Electronic address: vockleyg@upmc.edu.""}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Grange', 'Affiliation': 'Department of Pediatrics, Division of Genetics and Genomic Medicine, Washington University, 660 S Euclid Ave, St. Louis, MO 63110, United States of America. Electronic address: grangedk@wustl.edu.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health & Science University, Portland, OR 97239, United States of America. Electronic address: hardingc@ohsu.edu.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Decker', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America.'}, {'ForeName': 'Mingjin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: mili@bmrn.com.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: klau@bmrn.com.'}, {'ForeName': 'Orli', 'Initials': 'O', 'LastName': 'Rosen', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: orli.rosen@bmrn.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Larimore', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: KLarimore@bmrn.com.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Pediatrics, Section of Clinical Genetics and Metabolism, University of Colorado School of Medicine, 12605 E 16th St, Aurora, CO 80045, United States of America. Electronic address: janet.thomas@childrenscolorado.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.06.006']
2066,32593960,Functional recovery in multiple sclerosis patients undergoing rehabilitation programs is associated with plasma levels of hemostasis inhibitors.,"BACKGROUND


Increasing evidence for contribution of hemostasis components in multiple sclerosis (MS) has been reported. Hemostasis protein inhibitors display key regulatory roles, extending to regulation of innate immune response and inflammation, and promotion of blood-brain barrier integrity. Whereas the effects on hemostasis of exercise and rehabilitation strategies have been extensively investigated, relationships between MS rehabilitation strategies and hemostasis have not been previously reported.
OBJECTIVES


To investigate in MS patients the association between outcomes of rehabilitative exercise and plasma levels of selected hemostasis inhibitors.
METHODS


Sixty-one severely disabled progressive-MS (P-MS) patients were randomized in the RAGTIME trial to receive 12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT). Outcome parameters were: timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29). Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3). Descriptive analysis, trend analysis, Spearman's rank and Pearson's correlations, and multiple regression models were used.
RESULTS


Rehabilitative exercises moderately modified plasma protein concentrations. A significant trend to increase was observed for PS (p=0.015) and TFPI (p=0.047) in the whole population, and for PS (p=0.011) in the CT group. Correlation between TFPI and sTM levels was detectable at all time points in the whole P-MS patients and in RAGT group. The correlation between TFPI and PS, present at T0, was lost during the rehabilitation, and recovered at T3 in the whole population and CT group. During rehabilitation, positive variations of TFPI were inversely related with changes in 6MWT in the whole population (r=-0.309, p=0.021), and in the RAGT group (r=-0.51, p=0.004). In all P-MS, PS T0 levels were associated (r=0.379, p=0.004) with increased gait speed, which in the RAGT group was associated both with PS T0 (r=0.378, p=0.040), and sTM T0 (r=0.453, p=0.012). Accordingly, in the regression model including age, sex and EDSS and the stepwise enter of PS T0, higher PS T0 levels predicted increased gait speed in all P-MS (F=3.4, p=0.016) The regression model in the RAGT group indicated that higher PS and sTM T0 levels were both predictors of increased gait speed (F=5.7, p=0.001).
CONCLUSIONS


Plasma levels of coagulation inhibitors were related to variations of outcome measurements after high-intensity walking rehabilitation programs. Patients with decreased TFPI levels from T0 to T2 displayed the most significant functional recovery following rehabilitation, and particularly after RAGT. Higher baseline total PS levels were associated with favorable outcomes of rehabilitation therapies in MS. These novel findings, which suggest that plasma levels of hemostasis inhibitors might have implication for rehabilitative therapy options in MS, warrant further investigation.",2020,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","['Sixty-one severely disabled progressive-MS (P-MS) patients', 'multiple sclerosis patients undergoing rehabilitation programs', 'multiple sclerosis (MS']",['12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT'],"['PS T0 levels', 'TFPI levels', 'Higher baseline total PS levels', 'gait speed', 'Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI', 'timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29', 'plasma protein concentrations', 'PS', 'TFPI', 'PS and sTM T0 levels', 'TFPI and sTM levels', 'multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1168441', 'cui_str': 'Protein S total'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",61.0,0.0295241,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","[{'ForeName': 'Ziliotto', 'Initials': 'Z', 'LastName': 'Nicole', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara; School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.'}, {'ForeName': 'Lamberti', 'Initials': 'L', 'LastName': 'Nicola', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Manfredini', 'Initials': 'M', 'LastName': 'Fabio', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy; Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Straudi', 'Initials': 'S', 'LastName': 'Sofia', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Baroni', 'Initials': 'B', 'LastName': 'Marcello', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara.'}, {'ForeName': 'Tisato', 'Initials': 'T', 'LastName': 'Veronica', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carantoni', 'Initials': 'C', 'LastName': 'Matteo', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Secchiero', 'Initials': 'S', 'LastName': 'Paola', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Basaglia', 'Initials': 'B', 'LastName': 'Nino', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Marchetti', 'Initials': 'M', 'LastName': 'Giovanna', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Bernardi', 'Initials': 'B', 'LastName': 'Francesco', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara. Electronic address: ber@unife.it.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102319']
2067,31560382,Alcohol Consumption and Risk of Dementia and Cognitive Decline Among Older Adults With or Without Mild Cognitive Impairment.,"Importance


Substantial heterogeneity and uncertainty exist in the observed associations between alcohol consumption and dementia.
Objective


To assess the association between alcohol consumption and dementia and the roles of mild cognitive impairment (MCI) and apolipoprotein E ε4 (APOE E4) genotype in modifying this association.
Design, Setting, and Participants


This cohort study used data from the Ginkgo Evaluation of Memory Study, conducted from 2000 to 2008 among US community-dwelling participants. This study analyzed 3021 participants aged 72 years and older who were free of dementia. Data analysis was performed from 2017 to 2018.
Exposures


Self-reported alcohol consumption, drinking frequency, and quantity.
Main Outcomes and Measures


Using multivariable proportional hazards regression and linear mixed models, the risk of dementia and the rate of change over time in the Modified Mini-Mental State Examination were estimated.
Results


Among 3021 participants, the median (interquartile range) age was 78 (76-80) years; 1395 (46.2%) were female. During a median (interquartile range) follow-up of 6.0 (4.9-6.5) years, 512 cases of dementia occurred. For 7.1 to 14.0 drinks per week compared with less than 1.0 drink per week, the hazard ratios for dementia were 0.63 (95% CI, 0.38-1.06) among 2548 participants without MCI and 0.93 (95% CI, 0.47-1.84) among 473 participants with MCI. Among participants with MCI, the hazard ratio for dementia was 1.72 (95% CI, 0.87-3.40) for more than 14.0 drinks per week compared with less than 1.0 drink per week. The association of alcohol intake with dementia differed for participants with and without baseline MCI (P for interaction = .03). Among participants without MCI, daily low-quantity drinking was associated with lower dementia risk than infrequent higher-quantity drinking (hazard ratio, 0.45; 95% CI, 0.23-0.89; P = .02). Findings were consistent when stratified by sex, age, and APOE E4 genotype. Compared with drinking less than 1.0 drink per week, complete abstention (in participants without MCI) and the consumption of more than 14.0 drinks per week (in participants with MCI) were associated with lower Modified Mini-Mental State Examination scores (mean difference at follow-up compared with baseline, -0.46 point [95% CI, -0.87 to -0.04 point] and -3.51 points [95% CI, -5.75 to -1.27 points], respectively).
Conclusions and Relevance


In this study, complete abstention and consuming more than 14.0 drinks per week (compared with drinking <1.0 drink per week) were associated with lower cognitive scores among participants aged 72 years and older. Particular caution is needed among individuals with MCI who continue to drink alcohol.",2019,The association of alcohol intake with dementia differed for participants with and without baseline MCI (P for interaction = .03).,"['individuals with MCI who continue to drink alcohol', '3021 participants, the median (interquartile range) age was 78 (76-80) years; 1395 (46.2%) were female', 'Older Adults With or Without Mild Cognitive Impairment', '3021 participants aged 72 years and older who were free of dementia', '2000 to 2008 among US community-dwelling participants', 'participants aged 72 years and older']",[],"['lower cognitive scores', 'lower Modified Mini-Mental State Examination scores', 'hazard ratio for dementia', 'risk of dementia and the rate of change over time in the Modified Mini-Mental State Examination', 'hazard ratios for dementia', 'Alcohol Consumption and Risk of Dementia and Cognitive Decline', 'alcohol consumption, drinking frequency, and quantity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",3021.0,0.0996753,The association of alcohol intake with dementia differed for participants with and without baseline MCI (P for interaction = .03).,"[{'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Family Medicine, University of Washington, Seattle.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Nahin', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Lopez', 'Affiliation': 'Department of Neurology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'DeKosky', 'Affiliation': 'Department of Neurology, University of Florida, Gainesville.'}, {'ForeName': 'Lewis H', 'Initials': 'LH', 'LastName': 'Kuller', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Mackey', 'Affiliation': 'Department of Neurology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Majken K', 'Initials': 'MK', 'LastName': 'Jensen', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech, South San Francisco, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.10319']
2068,32599496,Randomized controlled three-arm study of NADA acupuncture for alcohol addiction.,"INTRODUCTION


Alcohol addiction compromises cardiovascular health, possibly due to impaired control of the heart and vasculature by the autonomic nervous system. We aimed to assess the effects of National Acupuncture Detoxification Association (NADA) acupuncture on cardiovascular autonomic functions, psychiatric comorbidities and abstinence in patients addicted to alcohol.
MATERIAL AND METHODS


A randomized sham controlled three-arm study was undertaken in 72 patients (nine females, aged 43.7 ± 9.2 years, mean ± SD) undergoing in-patient rehabilitation for alcohol addiction. Patients were randomly allocated (1:1:1) to receive twenty 30-minute NADA or sham acupuncture sessions within six weeks or no intervention. They were evaluated for craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response). Testing was performed at baseline, immediately post intervention (sham intervention or control period, respectively) and another four weeks later. Abstinence was assessed one year after study completion.
RESULTS


Patients in the NADA arm displayed increased HRV immediately post-intervention compared to baseline (SDNN: 72.8 ms ± 34.2 ms vs. 57.9 ms ± 31.2 ms, p = 0.001). This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015). HRV remained unaltered following sham or no acupuncture (p = n.s.). Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence did not differ between study arms.
CONCLUSIONS


NADA acupuncture may improve autonomic cardiac function. However, this improvement appears not to translate into alleviation of psychiatric comorbidities or sustained abstinence.",2020,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","['patients addicted to alcohol', '72 patients (nine females, aged 43.7\xa0±\xa09.2\xa0years, mean\xa0±\xa0SD) undergoing in-patient rehabilitation for alcohol addiction', '34.2']","['NADA or sham acupuncture sessions within six weeks or no intervention', 'National Acupuncture Detoxification Association (NADA) acupuncture', 'sham or no acupuncture', 'NADA acupuncture']","['HRV', 'Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence', 'craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response', 'autonomic cardiac function', 'cardiovascular autonomic functions, psychiatric comorbidities and abstinence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C5191359', 'cui_str': '34.2'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0038989', 'cui_str': 'Sweat gland structure'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",72.0,0.09429,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krause', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Penzlin', 'Affiliation': 'Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ritschel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Barlinn', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Reichmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Weidner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siepmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Siepmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. Electronic address: timo.siepmann@ukdd.de.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106488']
2069,32599497,A randomized comparison of estimated radiation exposure between Low and conventional dose protocol during invasive coronary angiography (ERICA trial): Pilot study.,"PURPOSE


Radiation exposure during coronary angiography is potentially harmful to patients and operators. However, there are limited data on the effects of a low-dose radiation angiography. We evaluated the feasibility and effectiveness of a reduced radiation dose protocol during invasive coronary angiography.
METHODS


One hundred three consecutive patients who underwent coronary angiography were enrolled and randomized to low- or conventional dose protocols (LDP versus CDP). The LDP consists of 10 frames per second during fluoroscopy and half the radiation dose of CDP during cineangiography. Image quality was assessed using a Likert rating scale by an independent radiologist. The radiation dose was estimated with dose-area product (DAP) and air-kerma (AK).
RESULTS


Body weight and waist circumference are well correlated with the level of DAP and AK. Exposure time and total images and frame counts in cineangiography were similar in both groups. There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP: LDP 1980.1 ± 1163.7 vs. CDP 3434.2 ± 2188.1 μGym 2  p = 0.001; total AK: 279.6 ± 159.3 vs. 493.8 ± 280.6 mGy, p < 0.001).
CONCLUSION


The LDP reduced the total estimated radiation dose compared to the CDP without a significant loss of diagnostic information. A LDP may be a viable strategy to protect patients and medical staff from the hazards of radiation in the cardiac catheterization laboratory.",2020,There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP:,['One hundred three consecutive patients who underwent'],"['estimated radiation exposure between Low and conventional dose protocol', 'low- or conventional dose protocols (LDP versus CDP', 'coronary angiography', 'CDP']","['Body weight and waist circumference', 'feasibility and effectiveness', 'Image quality', 'estimated radiation dose (DAP and AK', 'image quality (total DAP', 'Exposure time and total images and frame counts in cineangiography', 'Likert rating scale']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008188', 'cui_str': 'Chlordiazepoxide'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0008795', 'cui_str': 'Cineangiography'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",103.0,0.0489571,There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP:,"[{'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea. Electronic address: samipark@hanmail.net.'}, {'ForeName': 'Heung Cheol', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Christopher Y', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Utah Cardiology, Farmington, Utah, USA.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109120']
2070,32608096,A randomised clinical pilot trial to test the effectiveness of parent training with video modelling to improve functioning and symptoms in children with autism spectrum disorders and intellectual disability.,"BACKGROUND


Poor eye contact and joint attention are early signs of autism spectrum disorder (ASD) and important prerequisites for developing other socio-communicative skills. Teaching parents evidence-based techniques to improve these skills can impact the overall functioning of children with ASD. We aimed to analyse the impact of conducting a group parent-training intervention with video modelling to improve the intelligent quotient (IQ), social and communication functioning and to minimise symptoms in children with ASD and intellectual disability (ID).
METHODS


Study design: A multicentre, single-blinded, randomised clinical pilot trial of parent training using video modelling was conducted.
SAMPLE


Sixty-seven parents of children with ASD, aged between 3 and 6 years and with IQs between 50 and 70, were randomised: 34 to the intervention group and 33 to the control group. Intervention program: The intervention group received parent training over 22 sessions, and the control group received the standard community treatment.
INSTRUMENTS


Pre-evaluation and post-evaluation (week 28), the following were used: Autism Diagnostic Interview, Vineland Adaptive Behaviour Scale I, Snijders-Oomen Nonverbal Intelligence Test, Autism Behaviour Checklist and Hamilton Depression Rating Scale.
DATA ANALYSIS


Intention to treat and complier-average causal effect (CACE) were used to estimate the effects of the intervention.
RESULTS


There was a statistically significant improvement in the Vineland standardized communication scores in CACE (Cohen's d = 0.260). There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group. After the false discovery rate correction was applied, IQ remained statistically significant under both paradigms. The effect size for this adjusted outcome under the intention-to-treat paradigm was close to 0.4, and when considering adherence (CACE), the effect sizes were more robust (IQ's Cohen's d = 0.433).
CONCLUSIONS


Parent training delivered by video modelling can be a useful technique for improving the care given to children with ASD and ID, particularly in countries that lack specialists.",2020,There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group.,"['children with ASD', 'children with ASD and intellectual disability (ID', 'SAMPLE\n\n\nSixty-seven parents of children with ASD, aged between 3 and 6\xa0years and with IQs between 50 and 70, were randomised: 34 to the intervention group and 33 to the control group', 'children with autism spectrum disorders and intellectual disability']","['Intervention program', 'parent training with video modelling', 'parent training over 22 sessions, and the control group received the standard community treatment']","['Vineland standardized communication scores', 'I, Snijders-Oomen Nonverbal Intelligence Test, Autism Behaviour Checklist and Hamilton Depression Rating Scale', 'non-verbal IQ', 'functioning and symptoms', 'Autism Diagnostic Interview, Vineland Adaptive', 'autism symptomatology (Autism Behaviour Checklist total scores', 'Behaviour Scale', 'intelligent quotient (IQ), social and communication functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021705', 'cui_str': 'Intelligence test'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0700665,There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bordini', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Paula', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Cunha', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Caetano', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Bagaiolo', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Ribeiro', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'M C C', 'Initials': 'MCC', 'LastName': 'Martone', 'Affiliation': 'Department of Psychology - LAHMEI, Universidade Federal de São Carlos (UFSCar), Sao Carlos, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Portolese', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Moya', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brunoni', 'Affiliation': 'Development Disorders Program, Universidade Presbiteriana Mackenzie, Sao Paulo, Brazil.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bosa', 'Affiliation': 'Department of Psychology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Jesus Mari', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12759']
2071,32603531,Febuxostat therapy in outpatients with suspected COVID-19: A clinical trial.,"BACKGROUND


The aim of this clinical trial was to evaluate the effects of febuxostat (FBX) in comparison with hydroxychloroquine (HCQ) on clinical symptoms, laboratory tests and chest CT findings in outpatients with moderate symptoms of COVID-19 infection.
METHODS


We conducted a clinical trial involving adult outpatients with the moderate respiratory illness following COVID-19 infection. Patients were randomly assigned to receive either FBX or HCQ for 5 days. The measured variables were needs to hospitalisation, clinical and laboratory data including fever, cough, breathing rate, C-Reactive Protein level, lymphocytes count at onset of admission and was well as at 5 days of treatments. In addition, CT findings were evaluated on admission and 14 days after initiation of treatment.
RESULTS


Sixty subjects were enrolled in the study with a 1 to 1 ratio in FBX and HCQ groups. On admission, fever (66.7%), cough (87%), tachypnoea (44.4%), dyspnoea (35%), elevated CRP value (94.4%) and lung involvement according to chest CT (100%) were documented in enrolled patients with insignificant difference between FBX and HCQ groups. Fever, cough and tachypnoea were significantly mitigated in both groups after five days of treatments without any significant differences between groups. The mean percentages of lung involvement were significantly reduced to 7.3% and 8% after 14 days of treatment with FBX and HCQ, respectively. In adult outpatients with moderate COVID-19 infection, the effectiveness of FBX and HCQ was not different in terms of resolution of clinical manifestations, laboratory tests and lung CT findings.
CONCLUSION


This trial suggests that FBX is as an alternative treatment to HCQ for COVID-19 infection and may be considered in patients with a contraindication or precaution to HCQ.",2020,"Fever, cough and tachypnea were significantly mitigated in both groups after five days of treatments without any significant differences between groups.","['Sixty subjects were enrolled in the study with a 1 to 1 ratio in FBX and HCQ groups', 'outpatients with suspected COVID-19', 'patients with a contraindication or precaution to HCQ', 'adult outpatients with the moderate respiratory illness following COVID-19 infection', 'adult outpatients with moderate COVID-19 infection', 'outpatients with moderate symptoms of COVID-19 infection']","['Febuxostat therapy', 'FBX', 'hydroxychloroquine (HCQ', 'FBX or HCQ', 'febuxostat (FBX']","['hospitalization, clinical and laboratory data including fever, cough, breathing rate, C-Reactive Protein level, lymphocytes count at onset of admission', 'mean percentages of lung involvement', 'cough', 'Fever, cough and tachypnea', 'dyspnea', 'tachypnea', 'elevated CRP value']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0984218,"Fever, cough and tachypnea were significantly mitigated in both groups after five days of treatments without any significant differences between groups.","[{'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoodi', 'Affiliation': 'Department of Infection Diseases, Antimicrobial Resistance Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Abedi', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadeh-Navaei', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Rouhanizadeh', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ghasemali', 'Initials': 'G', 'LastName': 'Khorasani', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Hosseinimehr', 'Affiliation': 'Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}]",International journal of clinical practice,['10.1111/ijcp.13600']
2072,31896302,Dancing: More than a therapy for patients with venous insufficiency.,,2020,,['patients with venous insufficiency'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042485', 'cui_str': 'Peripheral venous insufficiency'}]",[],[],,0.0239979,,"[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Dogru-Huzmeli', 'Affiliation': 'Health Science Faculty, Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Iyad', 'Initials': 'I', 'LastName': 'Fansa', 'Affiliation': 'Tayfur Ata Sokmen Medical Faculty, Department of Cardiovascular Surgery, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Nilufer', 'Initials': 'N', 'LastName': 'Cetisli-Korkmaz', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Hatay, Turkey.'}, {'ForeName': 'Gul', 'Initials': 'G', 'LastName': 'Oznur-Karabicak', 'Affiliation': 'Health Science Faculty, Department of Physiotherapy and Rehabilitation, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Lale', 'Affiliation': 'Tayfur Ata Sokmen Medical Faculty, Department of Cardiovascular Surgery, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Ozden', 'Initials': 'O', 'LastName': 'Gokcek', 'Affiliation': 'Health Science Faculty, Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Yagmur', 'Initials': 'Y', 'LastName': 'Cam', 'Affiliation': 'Health Science Faculty, Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University, Hatay, Turkey.'}]",Vascular,['10.1177/1708538119893534']
2073,32604397,Association of Polymorphism rs67920064 in ADAMTS9 Gene with Mandibular Retrognathism in a Chinese Population.,"BACKGROUND Mandibular retrognathism is a common oral and maxillofacial deformity that may cause a series of physical and psychological diseases. Many studies indicated that genetic factors play an important role in the occurrence of mandibular retrognathism. In this study, we assess the association between polymorphism rs67920064 in ADAMTS9 gene and mandibular retrognathism in a Chinese population. MATERIAL AND METHODS Sixty participants (20 to 45 y, mean age 32.79 y) were classified into Class I or mandibular retrognathism skeletal-facial profile groups in accordance with cephalometric parameters. Thirty patients with mandibular retrognathism were assigned to the subject group; the others were assigned to the control group. Cephalometric parameters including sella-nasion A point, SN point B, condylion-gnathion (Gn), and gonion-Gn were recorded. Saliva samples from these participants were collected and polymerase chain reaction-restriction fragment length polymorphism was used to distinguish different genotypes of the rs67920064 single nucleotide polymorphisms (SNPs).We evaluated the correlation between mandibular retrognathism and polymorphism rs67920064 in the ADAMTS9 gene. RESULTS The distribution of rs67920064 gene polymorphism in ADAMST9 gene conforms to Hardy-Weinberg equilibrium. The A point-nasion-B point angle of the participants with the GA genotype of the rs67920064 SNP showed significantly decreased values (P<0.05), but there was no difference in length of mandibular body. Beyond that, the chi-square test showed that the GA genotype of rs67920064 SNP was highly associated with mandibular retrognathism (P<0.05). CONCLUSIONS Our research shows that there is an association between polymorphism rs67920064 in the ADAMTS9 gene and mandibular retrognathism in the Chinese population. Individuals with the GA phenotype are more likely to have mandibular retrognathism.",2020,The distribution of rs67920064 gene polymorphism in ADAMST9 gene conforms to Hardy-Weinberg equilibrium.,"['mandibular retrognathism in a Chinese population', 'Sixty participants (20 to 45 y, mean age 32.79 y) were classified into Class I or mandibular retrognathism skeletal-facial profile groups in accordance with cephalometric parameters', 'Thirty patients with mandibular retrognathism', 'Gene with Mandibular Retrognathism in a Chinese Population']",['ADAMTS9'],"['length of mandibular body', 'Cephalometric parameters including sella-nasion A point, SN point B, condylion-gnathion (Gn), and gonion-Gn']","[{'cui': 'C0266077', 'cui_str': 'Mandibular retrognathism'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0424476', 'cui_str': 'Facial profile'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C1257533', 'cui_str': 'ADAM-TS9 protein, human'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0222746', 'cui_str': 'Structure of body of mandible'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2924617', 'cui_str': 'Cephalometric nasion to a point line'}, {'cui': 'C2924613', 'cui_str': 'Cephalometric point B'}, {'cui': 'C3266676', 'cui_str': 'Cephalometric condylion point'}, {'cui': 'C1185651', 'cui_str': 'Cephalometric gonion point'}]",60.0,0.0312769,The distribution of rs67920064 gene polymorphism in ADAMST9 gene conforms to Hardy-Weinberg equilibrium.,"[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Weiting', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925965']
2074,32615109,"Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial.","BACKGROUND


Indications for liver transplantation for hepatocellular carcinoma are evolving and so-called expanded criteria remain debated. Locoregional therapies are able to downstage hepatocellular carcinoma from beyond to within the Milan criteria. We aimed to investigate the efficacy of liver transplantation after successful hepatocellular carcinoma downstaging.
METHODS


We did an open-label, multicentre, randomised, controlled trial designed in two phases, 2b and 3, at nine Italian tertiary care and transplantation centres. Patients aged 18-65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision. After an observation period of 3 months, during which sorafenib was allowed, patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors were randomly assigned (1:1) by an interactive web-response system to liver transplantation or non-transplantation therapies (control group). A block randomisation (block size of 2), stratified by centre and compliance to sorafenib treatment, was applied. Liver transplantation was done with whole or split organs procured from brain-dead donors. The control group received sequences of locoregional and systemic treatment at the time of demonstrated tumour progression. The primary outcomes were 5-year tumour event-free survival for phase 2b and overall survival for phase 3. Analyses were by intention to treat. Organ allocation policy changed during the course of the study and restricted patient accrual to 4 years. This trial is registered with ClinicalTrials.gov, NCT01387503.
FINDINGS


Between March 1, 2011, and March 31, 2015, 74 patients were enrolled. Median duration of downstaging was 6 months (IQR 4-11). 29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group. At data cutoff on July 31, 2019, median follow-up was 71 months (IQR 60-85). 5-year tumour event-free survival was 76·8% (95% CI 60·8-96·9) in the transplantation group versus 18·3% (7·1-47·0) in the control group (hazard ratio [HR] 0·20, 95% CI 0·07-0·57; p=0·003). 5-year overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035). The most common registered grade 3-4 serious adverse events were hepatitis C virus recurrence (three [13%] of 23 patients) and acute transplant rejection (two [9%]) in the transplantation group, and post-embolisation syndrome (two [9%] of 22 patients) in the control group. Treatment-related deaths occurred in four patients: two (8%) of 23 patients in the transplantation group (myocardial infarction and multi-organ failure) versus two (9%) of 22 patients in the control group (liver decompensation).
INTERPRETATION


Although results must be interpreted with caution owing to the early closing of the trial, after effective and sustained downstaging of eligible hepatocellular carcinomas beyond the Milan criteria, liver transplantation improved tumour event-free survival and overall survival compared with non-transplantation therapies Post-downstaging tumour response could contribute to the expansion of hepatocellular carcinoma transplantation criteria.
FUNDING


Italian Ministry of Health.",2020,"overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035).","['two phases, 2b and 3, at nine Italian tertiary care and transplantation centres', '29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group', 'Between March 1, 2011, and March 31, 2015, 74 patients were enrolled', 'hepatocellular carcinoma after tumour downstaging (XXL', '0·20', 'Patients aged 18-65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision', 'patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors']","['liver transplantation', 'sorafenib', 'Liver transplantation', 'interactive web-response system to liver transplantation or non-transplantation therapies (control group']","['5-year tumour event-free survival for phase 2b and overall survival', 'overall survival', 'tumour event-free survival', 'hepatitis C virus recurrence', 'acute transplant rejection', 'Median duration of downstaging', '5-year', 'deaths']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",74.0,0.208689,"overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035).","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mazzaferro', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy. Electronic address: vincenzo.mazzaferro@istitutotumori.mi.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Citterio', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Bhoori', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bongini', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'De Carlis', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Colledan', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Salizzoni', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Romagnoli', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Antonelli', 'Affiliation': ""Liver Transplant Unit and Gastroenterology Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vivarelli', 'Affiliation': 'Hepatobiliary and Abdominal Transplantation Surgery, Hepatology, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tisone', 'Affiliation': 'Department of Surgical Sciences and Medical Sciences University of Rome-Tor Vergata, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Department of General Surgery and Organ Transplantation, Sapienza University, Rome, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gruttadauria', 'Affiliation': 'Abdominal Surgery and Organ Transplantation Unit, Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, ISMETT, Palermo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Di Sandro', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'De Carlis', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Lucà', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Giorgio', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Mirabella', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Belli', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fagiuoli', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Martini', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Iavarone', 'Affiliation': ""Liver Transplant Unit and Gastroenterology Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Svegliati Baroni', 'Affiliation': 'Hepatobiliary and Abdominal Transplantation Surgery, Hepatology, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Angelico', 'Affiliation': 'Department of Surgical Sciences and Medical Sciences University of Rome-Tor Vergata, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ginanni Corradini', 'Affiliation': 'Department of General Surgery and Organ Transplantation, Sapienza University, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Volpes', 'Affiliation': 'Abdominal Surgery and Organ Transplantation Unit, Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, ISMETT, Palermo, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Regalia', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flores', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Droz Dit Busset', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Sposito', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30224-2']
2075,32615676,Repetitive Transcranial Magnetic Stimulation for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Pilot Study.,"PURPOSE


To evaluate the feasibility, efficacy, and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with treatment-resistant chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
METHODS


Eleven patients with CP/CPPS were enrolled in this prospective clinical study. rTMS was performed for 5 consecutive days in 20-minute sessions. Patients were evaluated at baseline, after treatment, and at 1, 4, 8, and 12 weeks after the last session with questionnaires concerning pain (numerical rating scale [NRS], the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI], and the Short Form-36 [SF-36]), urinary symptoms (NIH-CPSI, Danish Prostatic Symptom Score [DAN-PSS-1]), quality of life (NIH-CPSI, SF-36), and psychometrics (Beck Depression Index [BDI]). Telephone-based interviews were used to evaluate side effects, subjective response, and changes in drug consumption.
RESULTS


All patients completed the planned treatment and follow-up according to protocol. No patients experienced serious side effects or significant pain increase during or after treatment. Mild transient tension headache responsive to oral pain medication was reported by 2 patients. Decreased pain was observed on the NRS after treatment and at 1 and 8 weeks (P=0.019, P=0.006, P=0.042, respectively) and on the NIH-CPSI pain domain at 1 week (P=0.04). Improvement in lower urinary tract symptoms was observed after treatment in the NIH-CPSI urinary domain (P=0.02) but not with the DANPSS-1. No significant changes in the BDI were observed. Nine patients reported a positive overall subjective response (82%) and 6 patients (55%) were able to reduce pain medication. Higher age was associated with lower NRS scores after treatment (R=0.605, P=0.048) and at 8 weeks (R=0.659, P=0.028).
CONCLUSION


rTMS for patients with CP/CPPS seemed to be well tolerated, at least moderately effective in pain reduction, and might be of interest in patients with chronic pelvic pain resistant to conventional treatment. These findings remain to be confirmed by a randomized trial.",2020,"Decreased pain was observed on the NRS after treatment and at 1 and 8 weeks (P=0.019, P=0.006, P=0.042, respectively) and on the NIH-CPSI pain domain at 1 week (P=0.04).","['Chronic Prostatitis', 'Eleven patients with CP/CPPS', 'patients with chronic pelvic pain resistant to conventional treatment', 'patients with treatment-resistant chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS', 'Chronic Pelvic Pain Syndrome']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['pain (numerical rating scale [NRS], the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI], and the Short Form-36 [SF-36]), urinary symptoms (NIH-CPSI, Danish Prostatic Symptom Score [DAN-PSS-1]), quality of life (NIH-CPSI, SF-36), and psychometrics (Beck Depression Index [BDI', 'lower NRS scores', 'Decreased pain', 'BDI', 'positive overall subjective response', 'pain medication', 'Mild transient tension headache responsive to oral pain medication', 'side effects, subjective response, and changes in drug consumption', 'feasibility, efficacy, and safety', 'NIH-CPSI pain domain', 'lower urinary tract symptoms', 'serious side effects or significant pain increase']","[{'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",11.0,0.0245363,"Decreased pain was observed on the NRS after treatment and at 1 and 8 weeks (P=0.019, P=0.006, P=0.042, respectively) and on the NIH-CPSI pain domain at 1 week (P=0.04).","[{'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Nikkola', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Holm', 'Affiliation': 'Unit of Clinical Neurophysiology, Satakunta Hospital District, Pori, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Seppänen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Joutsi', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Esa', 'Initials': 'E', 'LastName': 'Rauhala', 'Affiliation': 'Unit of Clinical Neurophysiology, Satakunta Hospital District, Pori, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Kaipia', 'Affiliation': 'Department of Surgery, Satakunta Hospital District, Pori, Finland.'}]",International neurourology journal,['10.5213/inj.1938258.129']
2076,32627231,A multicomponent integrative intervention to slow down the progression of mild cognitive impairment: A protocol for a randomized controlled trial.,"Mild cognitive impairment affects 36% of people aged 65 years and over in China, and around 50% transition from mild cognitive impairment to dementia within 3 years. Early intervention can slow down disease progression and thus delay dementia onset. The purpose of this article is to outline the protocol of an ongoing randomized controlled trial in mainland China that will evaluate the effects and feasibility of a 6-month multicomponent integrative intervention on the speed of progression of mild cognitive impairment to dementia. Ninety-six community-dwelling older adults, aged 65 years and older, will be recruited (recruitment will be completed in May 2020), using strict inclusion/exclusion criteria, from two community health service centers in Guangzhou, Guangdong province. Participants will be allocated to receive either the multicomponent integrative intervention or usual care. The core components of the intervention are cognitive training, dietary instruction, physical activity, and management of vascular risk factors. Data are collected at the beginning of the study, then at 1, 3, and 6 months. The primary outcome is cognitive function. The main secondary outcomes are exercise capacity, comprehensive physical capacity, depression, and quality of life. An intention-to-treat analysis will be conducted. The study will be completed in 2021. The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.",2020,"The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.","['Ninety-six community-dwelling older adults, aged 65 years and older, will be recruited (recruitment will be completed in May 2020), using strict inclusion/exclusion criteria, from two community health service centers in Guangzhou, Guangdong province', 'mild cognitive impairment', 'mild cognitive impairment to dementia', 'Mild cognitive impairment affects 36% of people aged 65 years and over in China, and around 50% transition from mild cognitive impairment to dementia within 3 years']","['multicomponent integrative intervention', 'multicomponent integrative intervention or usual care']","['cognitive function', 'exercise capacity, comprehensive physical capacity, depression, and quality of life']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009472', 'cui_str': 'Community health services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.149996,"The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.","[{'ForeName': 'Qiyuan', 'Initials': 'Q', 'LastName': 'Lyu', 'Affiliation': 'School of Nursing, Jinan University, Guangzhou, China.'}, {'ForeName': 'Daphne S K', 'Initials': 'DSK', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Guangzhou, China.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Lai', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Yuanqiu', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Research Institute of Gynecology and Obstetrics, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",Research in nursing & health,['10.1002/nur.22050']
2077,32622394,"Ambulatory management of primary spontaneous pneumothorax: an open-label, randomised controlled trial.","BACKGROUND


Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care.
METHODS


In this open-label, randomised controlled trial, adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659.
FINDINGS


Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0-3]) than in the 113 with available data who received standard care (4 days [IQR 0-8]; p<0·0001; median difference 2 days [95% CI 1-3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging.
INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention.
FUNDING


UK National Institute for Health Research.",2020,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","['Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis', '110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm', '776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119', 'primary spontaneous pneumothorax', 'adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years', 'otherwise healthy young patients']","['ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both', 'ambulatory management compared with standard care']","['duration of hospitalisation including re-admissions', 'total length of hospital stay including re-admission', 'adverse events', 'median hospitalisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.148264,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","[{'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Hallifax', 'Affiliation': 'Oxford Centre for Respiratory Medicine, University of Oxford, Oxford, UK. Electronic address: robert.hallifax@ndm.ox.ac.uk.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McKeown', 'Affiliation': 'Royal Berkshire National Health Service (NHS) Foundation Trust, Reading, UK.'}, {'ForeName': 'Parthipan', 'Initials': 'P', 'LastName': 'Sivakumar', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fairbairn', 'Affiliation': 'Queen Margaret Hospital, NHS Fife, Dunfermline, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Peter', 'Affiliation': 'Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leitch', 'Affiliation': 'Western General Hospital, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stanton', 'Affiliation': 'Great Western Hospital NHS Foundation Trust, Swindon, UK.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Ijaz', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Marciniak', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cameron', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Amrithraj', 'Initials': 'A', 'LastName': 'Bhatta', 'Affiliation': 'Blackpool Fylde and Wyre Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Reddy', 'Affiliation': 'Kettering General Hospital, Kettering, UK.'}, {'ForeName': 'Marie-Clare', 'Initials': 'MC', 'LastName': 'Harris', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Maddekar', 'Affiliation': 'University Hospitals of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Corcoran', 'Affiliation': 'University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Corran', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31043-6']
2078,32622397,Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial.,"BACKGROUND


Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction.
METHODS


In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2·5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389.
FINDINGS


Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23·2 mL per s for TURP and 20·2 mL per s for ThuVARP; adjusted difference in means -3·12, 95% CI -5·79 to -0·45). Equivalence was shown for IPSS (mean 6·3 for TURP and 6·4 for ThuVARP; adjusted difference in means 0·28, -0·92 to 1·49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication.
INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,"INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax.","['men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction', 'Between July 23, 2014, and Dec 30, 2016, 410 men', 'men with lower urinary tract symptoms or urinary retention (UNBLOCS', 'men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction']","['TURP', 'ThuVARP technique', 'ThuVARP', 'Thulium laser transurethral vaporesection of the prostate versus transurethral resection', 'ThuVARP or TURP', 'TURP versus ThuVARP', 'Transurethral resection of the prostate (TURP', 'usual TURP procedure (monopolar or bipolar', 'Thulium laser transurethral vaporesection of the prostate (ThuVARP']","['maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS', 'Mean hospital stay', 'hospital stay and complications']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",410.0,0.20003,"INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax.","[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: h.hashim@gmail.com.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian M', 'Initials': 'SM', 'LastName': 'Noble', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sara T', 'Initials': 'ST', 'LastName': 'Brookes', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Department of Urology, Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'K Satchi', 'Initials': 'KS', 'LastName': 'Swami', 'Affiliation': 'Urology Department, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30537-7']
2079,32633648,Mildly Processed Natural Eggshell Membrane Alleviates Joint Pain Associated with Osteoarthritis of the Knee: A Randomized Double-Blind Placebo-Controlled Study.,"Poor joint health is a significant burden to society. Millions of people suffer from some form of joint-related disorder or disease, most often osteoarthritis (OA). It was hypothesized that chicken eggshell membrane (EM) is effective in the regeneration of cartilage and/or immunomodulation (oral tolerance), and as such relieves pain and stiffness in joints commonly affected in arthritis. We tested this hypothesis in a double-blind, placebo-controlled EM intervention study. Of 150 male and female volunteers, 40-75 years of age and diagnosed with knee OA, 75 were randomly assigned to the EM intervention group and 75 to the placebo group. During 12 weeks, subjects received a daily capsule containing either 300 mg of EM or a placebo. The main primary dependent variable consisted of self-reported pain ratings on a Numerical Rating Scale Pain (NRS-P) 6 weeks after study start. As secondary dependent variables served NRS-P scores collected after 12 weeks, and Knee injury and self-reported Osteoarthritis Outcome Scores (Knee injury and Osteoarthritis Outcome Scores [KOOS]). NRS-P scores decreased for both groups at approximately the same rate, but only EM relieved self-reported pain scores obtained with the KOOS questionnaire starting 1 week after initiation of treatment. This effect was significant for two of five KOOS category scores, that is, ""Pain"" and ""Daily Life"" functioning, aggregate pain, and functioning scores composed of complaint ratings for a wide variety of daily activities. These scores showed long-lasting improvement, and demonstrated that EM extract successfully reliefs knee OA pain and contributes to daily life functioning.",2020,"NRS-P scores decreased for both groups at approximately the same rate, but only EM relieved self-reported pain scores obtained with the KOOS questionnaire starting 1 week after initiation of treatment.","['150 male and female volunteers, 40-75 years of age and diagnosed with knee OA', 'Joint Pain Associated with Osteoarthritis of the Knee']","['EM intervention', 'Placebo', 'daily capsule containing either 300\u2009mg of EM or a placebo', 'placebo']","['pain scores', 'Knee injury and self-reported Osteoarthritis Outcome Scores (Knee injury and Osteoarthritis Outcome Scores [KOOS', 'Pain"" and ""Daily Life"" functioning, aggregate pain, and functioning scores', 'knee OA pain and contributes to daily life functioning', 'self-reported pain ratings on a Numerical Rating Scale Pain', 'NRS-P scores']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0013702', 'cui_str': 'Eggshell'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",150.0,0.585007,"NRS-P scores decreased for both groups at approximately the same rate, but only EM relieved self-reported pain scores obtained with the KOOS questionnaire starting 1 week after initiation of treatment.","[{'ForeName': 'Jeroen Lucas', 'Initials': 'JL', 'LastName': 'Kiers', 'Affiliation': 'JLK Nutrition, Amersfoort, The Netherlands.'}, {'ForeName': 'Johannes Hendrikus Franciscus', 'Initials': 'JHF', 'LastName': 'Bult', 'Affiliation': 'Applegg, Amersfoort, The Netherlands.'}]",Journal of medicinal food,['10.1089/jmf.2020.0034']
2080,32633801,Effect of Probiotic Use on Antibiotic Administration Among Care Home Residents: A Randomized Clinical Trial.,"Importance


Probiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited.
Objective


To determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents.
Design, Setting, and Participants


Placebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018.
Interventions


Study participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year.
Main Outcomes and Measures


The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.
Results


Among 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group.
Conclusions and Relevance


Among care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting.
Trial Registration


ISRCTN Identifier:16392920.",2020,"Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50).","['120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group', '310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial', 'care home residents', 'Care Home Residents', 'residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care', '310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018']","['Lactobacillus rhamnosus GG', 'Probiotic', 'Placebo', 'daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12', 'placebo']","['Antibiotic Administration', 'Participant diary data (daily data including study product use, antibiotic administration, and signs of infection', 'deaths', 'cumulative antibiotic administration days for all-cause infections', 'Hospitalizations']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0338046', 'cui_str': 'Residential home'}, {'cui': 'C0038931', 'cui_str': 'Nursing, Perioperative'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.418672,"Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50).","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Eleri', 'Initials': 'E', 'LastName': 'Owen-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Specialist Antimicrobial Chemotherapy Unit, Public Health Wales Microbiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Antony J', 'Initials': 'AJ', 'LastName': 'Bayer', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shepherd', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'F D Richard', 'Initials': 'FDR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davoudianfar', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rutter', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fuller', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}]",JAMA,['10.1001/jama.2020.8556']
2081,32629403,Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.,"BACKGROUND


Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability.
METHODS


This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability.
RESULTS


Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
CONCLUSIONS


Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.",2020,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
",['healthy subjects'],"['DMF', 'Monomethyl fumarate (MMF', 'MMF 190 mg vs DMF']","['LSMean AUC values', 'MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events', 'gastrointestinal tolerability profile', 'derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS', 'Area Under the Curve (AUC', 'safety/tolerability', 'Abdominal Pain', 'GI tolerability', 'severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C3848524', 'cui_str': 'monomethyl fumarate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0797155,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wynn', 'Affiliation': 'Consultants in Neurology, Ltd, Northbrook, IL 60062, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Lategan', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA. Electronic address: Lategan@bannerls.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Sprague', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Franck S', 'Initials': 'FS', 'LastName': 'Rousseau', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX 78681, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102335']
2082,32629625,"Effectiveness of a primary care clinical ultrasound classroom for family physicians as a formative intervention system, a quasi-experimental trial: Study protocol.","INTRODUCTION


Clinical ultrasound is a technique that increases diagnostic capacity and facilitates clinical decision making. The objective is to develop and validate an ultrasound training methodology oriented to the clinical practice of the family physician.
METHODS


Quasi-experimental study, with a before/after design, a control group, and 1 year of follow-up. Twenty family physicians working in primary care health centers with a list of over 800 patients will be included, as well as a control group of family physicians with similar characteristics in terms of age, sex, and patient list. A structured training process oriented to the clinical practice of the family physician, primary care clinical ultrasound classroom (AECAP), will be carried out, and the improvement of knowledge and skills of the participants will be evaluated, as well as the improvement of the quality of care based on clinical indicators.
DISCUSSION


The family physician is in a privileged situation allows increasing the performance of ultrasound in frequent clinical situations and reducing care hours. We hope that the results obtained in this study demonstrate the effectiveness of the structured training method (AECAP) and support the generalization of ultrasound in primary health care.
ETHICS AND DISSEMINATION


The study was approved by the Medical Research Ethics Committee of Salamanca on December 17, 2018 (cod 2018 11 134). The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number: NCT04283383.",2020,The family physician is in a privileged situation allows increasing the performance of ultrasound in frequent clinical situations and reducing care hours.,"['Twenty family physicians working in primary care health centers with a list of over 800 patients will be included, as well as a control group of family physicians with similar characteristics in terms of age, sex, and patient list', 'Salamanca on December 17, 2018 (cod 2018 11 134']","['primary care clinical ultrasound classroom', 'primary care clinical ultrasound classroom (AECAP', 'structured training method (AECAP']",[],"[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],800.0,0.02116,The family physician is in a privileged situation allows increasing the performance of ultrasound in frequent clinical situations and reducing care hours.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Diego-Domínguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Torrecilla-García', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Casado-Huerga', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'Maria Ángeles', 'Initials': 'MÁ', 'LastName': 'Paule-Sánchez', 'Affiliation': 'Centro de Salud de San Juan de Salamanca.'}, {'ForeName': 'Clara Isabel', 'Initials': 'CI', 'LastName': 'Soria-López', 'Affiliation': 'Centro de Salud de San Juan de Salamanca.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Iglesias-Clemente', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'de Dios-Hernández', 'Affiliation': 'Unidad Docente Multiprofesional de Atención Familiar y Comunitaria de Salamanca.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Diego-Mangas', 'Affiliation': 'Centro de Salud de Periurbana Norte, Servicio de Salud de Castilla y León, Salamanca, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Cubillo-Jiménez', 'Affiliation': 'Unidad Docente Multiprofesional de Atención Familiar y Comunitaria de Salamanca.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pérez-Escanilla', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}]",Medicine,['10.1097/MD.0000000000019914']
2083,32629698,Exercise-induced hypertension is associated with angiotensin II activity and total nitric oxide.,"Angiotensin II mediates exercise-induced hypertension (EIH), which adversely impacts future cardiovascular health. There is paucity of data on the association between EIH and angiotensin II in well-trained middle-aged marathoners. Therefore, we investigated the renin-angiotensin-aldosterone-system and total nitric oxide activity in middle-aged marathoners with EIH.Seventy middle-aged marathoners were divided into 3 groups: normal blood pressure ([NBPG] [n = 21]), EIH group ([EIHG] [n = 35]), and complex hypertension group ([CHG] [n = 14]). We defined NBPG as resting systolic BP/diastolic BP (SBP/DBP) of ≤140/90 mm Hg and maximal exercise SBP of ≤210 mm Hg, EIHG as resting SBP/DBP ≤140/90 mm Hg and maximal exercise SBP of ≥210 mm Hg, and CHG as resting SBP/DBP ≥140/90 mm Hg and maximal exercise SBP of ≥210 mm Hg. Renin-angiotensin-aldosterone-system and NO levels were measured before and 30 minutes after the graded exercise test.Renin level was elevated while angiotensin level was reduced after 30 minutes of graded exercise test. There was no change in angiotensin I and angiotensin converting enzyme levels. Comparing the groups, renin level was only elevated in the CHG during recovery, while aldosterone level was higher than the baseline level in the recovery phase in all groups. Angiotensin I level remained unchanged in all groups. Angiotensin II level reduced significantly in the NBPG group but remained at the baseline in the EIHG and CHG groups. NO level was unchanged in the NBPG group but reduced in the EIHG and CHG groups after exercise. At 3 minutes of recovery, SBP was the highest in the NBPG group, followed by the EIHG and CHG groups (P < .05).In conclusion, angiotensin II activity and reduced NO level are associated with EIH in middle-aged long-distance runners. Angiotensin II inhibitors may; therefore, be the more appropriate antihypertensive medication for runners with EIH.",2020,Angiotensin II level reduced significantly in the NBPG group but remained at the baseline in the EIHG and CHG groups.,"['middle-aged marathoners with EIH.Seventy middle-aged marathoners', 'runners with EIH', 'middle-aged long-distance runners']","['normal blood pressure ([NBPG] [n\u200a=\u200a21]), EIH group ([EIHG] [n\u200a=\u200a35]), and complex hypertension group ([CHG', 'renin-angiotensin-aldosterone-system and total nitric oxide activity', 'NBPG', 'Angiotensin II mediates exercise-induced hypertension (EIH']","['angiotensin level', 'Renin-angiotensin-aldosterone-system and NO levels', 'Renin level', 'Angiotensin II level', 'aldosterone level', 'Angiotensin I level', 'angiotensin II activity and reduced NO level', 'NO level', 'resting systolic BP/diastolic BP (SBP/DBP', 'angiotensin I and angiotensin converting enzyme levels', 'renin level']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0008586', 'cui_str': 'Chromogranin'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}]",,0.0210193,Angiotensin II level reduced significantly in the NBPG group but remained at the baseline in the EIHG and CHG groups.,"[{'ForeName': 'Chul-Hyun', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Sports Medicine, Soonchunhyang University, Asan.'}, {'ForeName': 'Yongbum', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Sanggye Paik Hospital, Inje University College of Medicine.'}, {'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Chun', 'Affiliation': ""Department of Global Medical Science, Soojung Campus, Sungshin Women's University, Seoul, Republic of Korea.""}, {'ForeName': 'Young-Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': ""Department of Exercise Rehabilitation Welfare, Soojung Campus, Sungshin Women's University, Seoul, Republic of Korea.""}]",Medicine,['10.1097/MD.0000000000020943']
2084,32629706,The evaluation of a nurse-led hypertension management model in an urban community healthcare: A randomized controlled trial.,"BACKGROUND


Hypertension is a silent disease of the masses with an increasing prevalence and poor control rates. This study aims to establish and test the efficacy of a nurse-led hypertension management model in the community.
METHODS


A single-blind, randomized controlled trial was performed. 156 hypertensive patients with uncontrolled blood pressure were equally and randomly allocated into 2 groups. Patients in the study group received a 12-week period of hypertension management. Blood pressure, self-care behaviors, self-efficacy, and satisfaction were assessed at the start of recruitment, 12 and 16 weeks thereafter.
RESULTS


After the intervention, blood pressure of patients in the study group had greater improvement in self-care behaviors and a higher level of satisfaction with the hypertensive care compared to the control group (both P < .05).
CONCLUSIONS


The nurse-led hypertension management model is feasible and effective for patients with uncontrolled blood pressure in the community.",2020,"After the intervention, blood pressure of patients in the study group had greater improvement in self-care behaviors and a higher level of satisfaction with the hypertensive care compared to the control group (both P < .05).
","['156 hypertensive patients with uncontrolled blood pressure', 'patients with uncontrolled blood pressure in the community', 'urban community healthcare']","['nurse-led hypertension management model', 'hypertension management']","['Blood pressure, self-care behaviors, self-efficacy, and satisfaction', 'blood pressure', 'level of satisfaction with the hypertensive care', 'self-care behaviors']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]",156.0,0.035059,"After the intervention, blood pressure of patients in the study group had greater improvement in self-care behaviors and a higher level of satisfaction with the hypertensive care compared to the control group (both P < .05).
","[{'ForeName': 'Jian-Hong', 'Initials': 'JH', 'LastName': 'Miao', 'Affiliation': ""Tangshan Worker's Hospital, Tangshan.""}, {'ForeName': 'Hai-Shan', 'Initials': 'HS', 'LastName': 'Wang', 'Affiliation': 'TangShan FuYou BaoJianYuan.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'TangShan Chinese Medicine Hospital, Heibei, P.R. China.'}]",Medicine,['10.1097/MD.0000000000020967']
2085,32629737,Clinical research for whether the Traditional Chinese medicine could promote the resorption of lumbar disc herniation: a randomized controlled trial.,"Lumbar disc herniation (LDH) is a common, disabling musculoskeletal disorder. Magnetic resonance imaging has clarified the natural history of lumbar disc lesions and has documented that disc lesions can become smaller and can even be completely resorbed. Previous studies have confirmed that some traditional Chinese medicine (TCM) therapies can promote resorption of the protrusion. However, high-quality research evidence is needed to support the effectiveness of the protocol.
OBJECTIVE


This clinical trial aims to establish whether TCM can promote the resorption of LDH and to assess the efficacy of such therapy for LDH, thereby evaluating its clinical effect.
METHODS


The present study design is for a single-center, 2-arm, open-label randomized controlled trial. A total of 150 eligible LDH patients will be randomly assigned to either a TCM treatment group or a control group in a 1:1 ratio. Patients in the TCM group will be administered a TCM decoction for 4 weeks. Patients in the conventional drug control group will be instructed to take a specific daily dose of celecoxib. The primary outcome measure is the change from baseline in the volume of the protrusion, as assessed using MR images. Secondary outcome measures include visual analog scale pain scores and Japanese Orthopaedic Association scores assessed at 3 and 6 months.
DISCUSSION


The design and methodological rigor of this trial will allow evaluation of the basic clinical efficacy and safety data for TCM in the treatment of patients with LDH. The trial will also assess whether TCM can promote the resorption of LDH. This research will therefore help provide a solid foundation for the clinical treatment of LDH and for future research in TCM therapy.
TRIAL REGISTRATION


ChiCTR1900022377.",2020,Magnetic resonance imaging has clarified the natural history of lumbar disc lesions and has documented that disc lesions can become smaller and can even be completely resorbed.,"['150 eligible LDH patients', 'patients with LDH']","['TCM', 'TCM decoction', 'Traditional Chinese medicine', 'celecoxib', 'Magnetic resonance imaging', 'Lumbar disc herniation (LDH']","['visual analog scale pain scores and Japanese Orthopaedic Association scores assessed at 3 and 6 months', 'change from baseline in the volume of the protrusion, as assessed using MR images', 'resorption of lumbar disc herniation']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0410592', 'cui_str': 'Resorption of lumbar disc'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",150.0,0.203265,Magnetic resonance imaging has clarified the natural history of lumbar disc lesions and has documented that disc lesions can become smaller and can even be completely resorbed.,"[{'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Chunchun', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': 'Shanghai Traditional Chinese Medicine Hospital, PR China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai.'}, {'ForeName': 'Dezhi', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai.'}]",Medicine,['10.1097/MD.0000000000021069']
2086,32629738,The analgesic efficiency of pregabalin for the treatment of postoperative pain in total hip arthroplasty: A randomized controlled study protocol.,"BACKGROUND


Only few studies have yet investigated whether perioperative administration of pregabalin can reduce the incidence of postoperative chronic neuropathic pain after total hip arthroplasty (THA). This prospective, randomized study compared placebo with pregabalin in the hope that a lower pregabalin dose would improve analgesia without increasing side-effects after THA.
METHODS


This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. The study was approved by the Institutional Review Board in Weifang People's Hospital and written informed consent was obtained from all subjects before enrolment. A total of 120 patients who meet inclusion criteria are randomized to either pregabalin or placebo group. The primary objective of the study was visual analog scale score. As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.
RESULTS


The null hypothesis of this study was that pregabalin would reduce pain after THA.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5669).",2020,"As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.
","['after total hip arthroplasty (THA', '120 patients who meet inclusion criteria', 'total hip arthroplasty']","['pregabalin', 'placebo with pregabalin', 'pregabalin or placebo']","['postoperative chronic neuropathic pain', 'opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications', 'analgesic efficiency', 'visual analog scale score', 'pain']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.187717,"As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.
","[{'ForeName': 'Yuangui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Weifang People's Hospital, Shandong 261000, China.""}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Guimin', 'Initials': 'G', 'LastName': 'Dong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021071']
2087,32593791,Differential effects of modafinil on performance of low-performing and high-performing individuals during total sleep deprivation.,"BACKGROUND


Individual responses to the effects of inadequate sleep have been well documented; some people are more vulnerable to the effects of sleep loss than others. Fatigue-vulnerable individuals generally require access to effective fatigue countermeasures; however, the question arises as to whether these fatigue-vulnerable individuals receive the same benefits shown in group efficacy data. The present study administered modafinil to individuals to determine its differential effects on performance of best and worst performers during sleep deprivation.
METHODS


A sample of 22 men, age 21-40 yrs., was tested on 2 separate occasions during which they were kept awake for 36 h. During one period they received 200 mg modafinil; during the other they received placebo. Participants were tested on a variety of tasks while rested and at 5-hr intervals across the continuous wakefulness period. Performance for each cognitive task and subjective measure of fatigue from the placebo period was used to group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task.
RESULTS


Results indicated that on the MTS task, the HP group performed the same throughout the testing period, regardless of whether they received modafinil or not. However, the LP group significantly improved after receiving modafinil compared to placebo. Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo. Performance on the RDM showed no difference between groups, regardless of drug condition. Groups did not differ after receiving modafinil on subjective fatigue measured by the POMS.
CONCLUSIONS


Depending on the task, HP individuals did not benefit substantially when administered modafinil compared to placebo. However, the LP individuals improved after receiving modafinil compared to placebo.",2020,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","['low-performing and high-performing individuals during total sleep deprivation', 'group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task', 'A sample of 22 men, age 21-40\u202fyrs., was tested on 2 separate occasions during which they were kept awake for 36\u202fh']","['modafinil', '200\u202fmg modafinil', 'placebo']","['subjective fatigue', 'lapses', 'number of lapses']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.090569,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","[{'ForeName': 'J Lynn', 'Initials': 'JL', 'LastName': 'Caldwell', 'Affiliation': 'Naval Medical Research Unit Dayton, United States of America. Electronic address: jo.caldwell@us.af.mil.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Schroeder', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Kunkle', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Henry G', 'Initials': 'HG', 'LastName': 'Stephenson', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172968']
2088,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
2089,32593918,Early initiated postoperative rehabilitation enhances quality of life in patients with operable lung cancer: Secondary outcomes from a randomized trial.,"INTRODUCTION


Patients with lung cancer report a lower degree of Health Related Quality of Life (HRQoL) compared with other cancer patients. HRQoL reflects how patients experience the impact of their disease and its treatment on their quality of daily living. A widely used questionnaire in lung cancer patients is the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. Here we report the secondary outcomes on FACT-L data from the Postoperative Rehabilitation in Operation for Lung CAncer (PROLUCA) study, which describes the effect of early (14 days) versus late initiated (14 weeks) postoperative rehabilitation.
MATERIALS AND METHODS


The PROLUCA study was designed as a two-armed randomized controlled trial with an early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group (14 weeks after surgery (LRG)). The results for seven domain scores obtained using the FACT-L at the following time-points: baseline, 14 weeks, 26 weeks and 52 weeks after surgery are presented here.
RESULTS


119 patients were randomized to the ERG and 116 to the LRG. In the ERG, HRQoL measured by both FACT-L and FACT-G (general core instrument) showed a continuous improvement up to 26 weeks after which HRQoL decreased after further 26 weeks without structured intervention. In the LRG a non-significant deterioration was detected over the first 14 weeks after surgery. After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
CONCLUSION


Analyses of the seven domain scores obtained using FACT-L and FACT-G reflect the importance of starting exercise early after surgery since the ERG avoid a temporary decrease in HRQoL. It is therefore recommended to start up a structured rehabilitation program 14 days after surgery, containing high intensity interval training and strength exercise twice a week for 12 weeks.",2020,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
","['lung cancer patients', 'patients with operable lung cancer', '119 patients']","['postoperative rehabilitation', 'early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group']","['quality of life', 'Health Related Quality of Life (HRQoL', 'HRQoL']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205188', 'cui_str': 'Operable'}]","[{'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",119.0,0.0636671,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
","[{'ForeName': 'Maja Schick', 'Initials': 'MS', 'LastName': 'Sommer', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark. Electronic address: mss@kraeftcenter-kbh.dk.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Vibe-Petersen', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Maja Bohlbro', 'Initials': 'MB', 'LastName': 'Stærkind', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Klaus Richter', 'Initials': 'KR', 'LastName': 'Larsen', 'Affiliation': 'Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Trier', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Clementsen', 'Affiliation': 'Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark; Copenhagen Academy for Medical Education and Simulation, University of Copenhagen and the Capital Region of Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Missel', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'Department of Public Health, Faculty of Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.023']
2090,32593936,Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial.,"OBJECTIVE


Endometrial scratch injury (ESI) has been proposed to improve endometrial receptivity and thereby increase implantation rates in assisted reproductive technology (ART) treatment. ESI has been widely incorporated into clinical practice despite inconclusive evidence of its effect on reproductive outcomes. We aimed to assess pregnancy and live birth rates in subfertile women receiving ESI before IVF treatment in comparison to controls.
STUDY DESIGN


This was a randomised controlled trial (RCT) with no blinding of participants, investigators or health care personnel. Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group). In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis. The primary outcome was positive serum hCG (s-hCG). Secondary outcomes were ongoing pregnancy and live birth rate. Only per-protocol analyses were performed as all patients included at one centre had to be excluded. The trial is registered at ClinicalTrials.gov, NCT01743391.
RESULTS


Our results showed a non-significant increase in positive s-hCG (OR 1.23, 95 % CI (0.65-2.33)), ongoing pregnancy (OR 1.52, 95 % CI (0.73-3.17)), and live birth rates (OR 1.69, 95 % CI (0.78-3.64)) per randomised woman between the ESI and the control group.
CONCLUSION


We observed no significant differences in positive s-hCG or other reproductive outcomes in the ESI vs. the control group. While the crude estimates of positive reproductive outcomes were higher in the ESI group, statistical significance was not reached, and the study was not powered to show smaller differences. However, data from this study will be re-evaluated in the context of an individual participant data meta-analysis (IPD-MA) of RCTs on ESI.",2020,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"['In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis', 'Endometrial scratch injury with office hysteroscopy before IVF/ICSI', 'subfertile women receiving ESI before IVF treatment in comparison to controls', 'Women in ART treatment', 'participants, investigators or health care personnel']","['office hysteroscopy with ESI (ESI group) or no intervention (control group', 'ESI']","['positive reproductive outcomes', 'live birth rates', 'ongoing pregnancy and live birth rate', 'ongoing pregnancy', 'positive s-hCG', 'pregnancy and live birth rates', 'positive serum hCG (s-hCG']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technologies'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}]",184.0,0.498981,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"[{'ForeName': 'Sine', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark. Electronic address: sine.berntsen.01@regionh.dk.'}, {'ForeName': 'Kristine Juul', 'Initials': 'KJ', 'LastName': 'Hare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Palmø', 'Affiliation': 'Department of Obstetrics and Gynaecology, Holbaek Hospital, Smedelundsgade 60, 4300 Holbaek, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.034']
2091,32602588,Nursing Home Care Intervention Post Stroke (SHARE) 1 year effect on the burden of family caregivers for older adults in Brazil: A randomized controlled trial.,"The purpose of this study is to evaluate the effect of home-care nursing intervention on the burden of family caregivers for older adults surviving a stroke. A randomised clinical trial blinded for outcome evaluation. Forty-eight family caregivers of older adults surviving a stroke took part in the study. The intervention group (IG) received three home visits by nurses in 1 month after hospital discharge for guidance on the disease and care activities for the elderly people. The control group (CG) relied on the service network that had access. The Caregiver Burden Scale was applied to assess the burden outcome 1 week, 60 days and 1 year after hospital discharge. The caregivers of the intervention and CGs had no difference regarding baseline data. There was an interaction effect between the CG and the IG in the isolation domain (p = 0.037) and in the emotional involvement domain (p = 0.003) over time. These findings provide support for strengthening a care line for the elderly people after a stroke, with adequate discharge planning, indicating the importance of integrating care network services such as primary care, home care and hospital care with a view to achieving an effective care transition. It is also necessary to construct a specific instrument to evaluate other outcomes, such as the knowledge and learning of caregivers in relation to the care activities taught. This study is registered in the Clinical Trials with name Nursing Home Care Intervention Post Stroke (SHARE) and under number NCT02807012.",2020,There was an interaction effect between the CG and the IG in the isolation domain (p = 0.037) and in the emotional involvement domain (p = 0.003) over time.,"['Forty-eight family caregivers of older adults surviving a stroke took part in the study', 'older adults surviving a stroke', 'older adults in Brazil']","['intervention group (IG) received three home visits by nurses in 1\xa0month after hospital discharge for guidance on the disease and care activities', 'Nursing Home Care Intervention Post Stroke (SHARE', 'home-care nursing intervention']",['burden of family caregivers'],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]",,0.0611968,There was an interaction effect between the CG and the IG in the isolation domain (p = 0.037) and in the emotional involvement domain (p = 0.003) over time.,"[{'ForeName': 'Carolina B', 'Initials': 'CB', 'LastName': 'Day', 'Affiliation': 'School of health and life sciences, Pontifical Catholic University of Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Carla C B K', 'Initials': 'CCBK', 'LastName': 'Bierhals', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Mocellin', 'Affiliation': 'Conceição Hospital Group, Porto Alegre, Brazil.'}, {'ForeName': 'Mariane L', 'Initials': 'ML', 'LastName': 'Predebon', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Naiana O', 'Initials': 'NO', 'LastName': 'Santos', 'Affiliation': 'Nursing Department, Franciscan University Center (UNIFRA), Santa Maria, Brazil.'}, {'ForeName': 'Fernanda L F', 'Initials': 'FLF', 'LastName': 'Dal Pizzol', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Fuhrmann', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Marinês', 'Initials': 'M', 'LastName': 'Aires', 'Affiliation': 'Health of Science Department, Integrated Regional University of Alto Uruguai and Missões, Itapajé, Brazil.'}, {'ForeName': 'Lisiane M G', 'Initials': 'LMG', 'LastName': 'Paskulin', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}]",Health & social care in the community,['10.1111/hsc.13068']
2092,32602592,Cognitive evolutionary therapy versus standard cognitive therapy for depression: A single-blinded randomized clinical trial.,"OBJECTIVE


To compare the efficacy of cognitive evolutionary therapy (CET) with cognitive therapy (CT) for depression.
METHODS


Ninety-seven participants (78 females/19 males) were randomized to a single-blinded controlled trial (CET: n = 51 vs. CT: n = 46). Assessments were conducted at baseline, Sessions 4 and 8, posttreatment, and 3-month follow-up. Clinical diagnoses were made with Structured Clinical Interview for DSM-IV (SCID) and self-reports for depression and secondary outcomes.
RESULTS


Although both groups showed significant reductions in depressive symptomatology, the overall Time × Treatment group interaction in the intent to treat analysis was not significant (p = .770, posttreatment: d = 0.39). However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62). The between-group differences generally diminished at the 3-month follow-up.
CONCLUSIONS


CET is a novel therapy for depression that may add therapeutic benefits beyond those of CT.",2020,"However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62).","['Ninety-seven participants (78\xa0females/19\xa0males', 'depression']","['CT', 'cognitive evolutionary therapy (CET) with cognitive therapy (CT', 'Cognitive evolutionary therapy versus standard cognitive therapy', 'CET']","['depressive symptomatology', 'behavioral inhibition/avoidance', 'social and enjoyable activities']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",97.0,0.0923318,"However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62).","[{'ForeName': 'Cezar', 'Initials': 'C', 'LastName': 'Giosan', 'Affiliation': 'Department of Psychology, University of Bucharest, Bucharest, Romania.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Cobeanu', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Department of Epidemiology and Biostatistics, Graduate School of Public Health and Health Policy, City University of New York, New York, USA.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Muresan', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mogoase', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Szentagotai', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Malta', 'Affiliation': 'Capital Psychological Associates, Albany, New York, USA.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Moldovan', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}]",Journal of clinical psychology,['10.1002/jclp.22991']
2093,32599716,Effects of Creatine Supplementation during Resistance Training Sessions in Physically Active Young Adults.,"The purpose was to examine the effects of creatine supplementation during resistance training sessions on skeletal muscle mass and exercise performance in physically active young adults. Twenty-two participants were randomized to supplement with creatine (CR:  n  = 13, 26 ± 4 yrs; 0.0055 g·kg -1  post training set) or placebo (PLA:  n  = 9, 26 ± 5 yrs; 0.0055 g·kg -1  post training set) during six weeks of resistance training (18 sets per training session; five days per week). Prior to and following training and supplementation, measurements were made for muscle thickness (elbow and knee flexors/extensors, ankle plantarflexors), power (vertical jump and medicine ball throw), strength (leg press and chest press one-repetition maximum (1-RM)) and muscular endurance (one set of repetitions to volitional fatigue using 50% baseline 1-RM for leg press and chest press). The creatine group experienced a significant increase ( p  < 0.05) in leg press, chest press and total body strength and leg press endurance with no significant changes in the PLA group. Both groups improved total body endurance over time ( p  < 0.05), with greater gains observed in the creatine group. In conclusion, creatine ingestion during resistance training sessions is a viable strategy for improving muscle strength and some indices of muscle endurance in physically active young adults.",2020,"The creatine group experienced a significant increase ( p  < 0.05) in leg press, chest press and total body strength and leg press endurance with no significant changes in the PLA group.","['Physically Active Young Adults', 'physically active young adults']","['Creatine Supplementation', 'placebo (PLA:  n  = 9, 26 ± 5 yrs; 0.0055 g·kg -1  post training set) during six weeks of resistance training', 'resistance training sessions', 'supplement with creatine (CR', 'creatine supplementation']","['muscle thickness (elbow and knee flexors/extensors, ankle plantarflexors), power (vertical jump and medicine ball throw), strength (leg press and chest press one-repetition maximum (1-RM)) and muscular endurance (one set of repetitions to volitional fatigue', 'total body endurance', 'skeletal muscle mass and exercise performance', 'leg press, chest press and total body strength and leg press endurance']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",22.0,0.0489477,"The creatine group experienced a significant increase ( p  < 0.05) in leg press, chest press and total body strength and leg press endurance with no significant changes in the PLA group.","[{'ForeName': 'Scotty', 'Initials': 'S', 'LastName': 'Mills', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S0A2, Canada.'}, {'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S0A2, Canada.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, MB R7A6A9, Canada.'}, {'ForeName': 'J Patrick', 'Initials': 'JP', 'LastName': 'Neary', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S0A2, Canada.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Institute of Sports Sciences & Medicine, Department of Nutrition, Food, & Exercise Sciences, Florida State University, Tallahassee, FL 32313, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Antonio', 'Affiliation': 'Department of Health and Human Performance, Nova Southeastern University, Davie, FL 33314, USA.'}]",Nutrients,['10.3390/nu12061880']
2094,32608353,"A web-based, peer-supported self-management intervention to reduce distress in relatives of people with psychosis or bipolar disorder: the REACT RCT.","BACKGROUND


Relatives caring for people with severe mental health problems find information and emotional support hard to access. Online support for self-management offers a potential solution.
OBJECTIVE


The objective was to determine the clinical effectiveness and cost-effectiveness of an online supported self-management tool for relatives: the Relatives' Education And Coping Toolkit (REACT).
DESIGN AND SETTING


This was a primarily online (UK), single-blind, randomised controlled trial, comparing REACT plus a resource directory and treatment as usual with the resource directory and treatment as usual only, by measuring user distress and other well-being measures at baseline and at 12 and 24 weeks.
PARTICIPANTS


A total of 800 relatives of people with severe mental health problems across the UK took part; relatives who were aged ≥ 16 years, were experiencing high levels of distress, had access to the internet and were actively seeking help were recruited.
INTERVENTION


REACT comprised 12 psychoeducation modules, peer support through a group forum, confidential messaging and a comprehensive resource directory of national support. Trained relatives moderated the forum and responded to messages.
MAIN OUTCOME MEASURE


The main outcome was the level of participants' distress, as measured by the General Health Questionnaire-28 items.
RESULTS


Various online and offline strategies, including social media, directed potential participants to the website. Participants were randomised to one of two arms: REACT plus the resource directory ( n  = 399) or the resource directory only ( n  = 401). Retention at 24 weeks was 75% (REACT arm,  n  = 292; resource directory-only arm,  n  = 307). The mean scores for the General Health Questionnaire-28 items reduced substantially across both arms over 24 weeks, from 40.2 (standard deviation 14.3) to 30.5 (standard deviation 15.6), with no significant difference between arms (mean difference -1.39, 95% confidence interval -3.60 to 0.83;  p  = 0.22). At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03;  p  = 0.027), but this finding is likely to be of limited clinical significance. Accounting for missing data, which were associated with higher distress in the REACT arm (0.33, 95% confidence interval -0.27 to 0.93;  p  = 0.279), in a longitudinal model, there was no significant difference between arms over 24 weeks (-0.56, 95% confidence interval -2.34 to 1.22;  p  = 0.51). REACT cost £142.95 per participant to design and deliver (£62.27 for delivery only), compared with £0.84 for the resource directory only. A health economic analysis of NHS, health and Personal Social Services outcomes found that REACT has higher costs (£286.77), slightly better General Health Questionnaire-28 items scores (incremental General Health Questionnaire-28 items score adjusted for baseline, age and gender: -1.152, 95% confidence interval -3.370 to 1.065) and slightly lower quality-adjusted life-year gains than the resource directory only; none of these differences was statistically significant. The median time spent online was 50.8 minutes (interquartile range 12.4-172.1 minutes) for REACT, with no significant association with outcome. Participants reported finding REACT a safe, confidential environment (96%) and reported feeling supported by the forum (89%) and the REACT supporters (86%). No serious adverse events were reported.
LIMITATIONS


The sample comprised predominantly white British females, 25% of participants were lost to follow-up and dropout in the REACT arm was not random.
CONCLUSIONS


An online self-management support toolkit with a moderated group forum is acceptable to relatives and, compared with face-to-face programmes, offers inexpensive, safe delivery of National Institute for Health and Care Excellence-recommended support to engage relatives as peers in care delivery. However, currently, REACT plus the resource directory is no more effective at reducing relatives' distress than the resource directory only.
FUTURE WORK


Further research in improving the effectiveness of online carer support interventions is required.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN72019945.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 32. See the NIHR Journals Library website for further project information.",2020,"At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03;  p  = 0.027), but this finding is likely to be of limited clinical significance.","['relatives of people with psychosis or bipolar disorder', 'Relatives caring for people with severe mental health problems', 'relatives', 'A total of 800 relatives of people with severe mental health problems across the UK took part; relatives who were aged ≥\u200916 years, were experiencing high levels of distress, had access to the internet and were actively seeking help were recruited']","['REACT plus the resource directory ( n \u2009=\u2009399) or the resource directory only', 'REACT', 'peer-supported self-management intervention']","['General Health Questionnaire-28 items scores (incremental General Health Questionnaire-28 items score', ""level of participants' distress, as measured by the General Health Questionnaire-28 items"", 'clinical effectiveness and cost-effectiveness', 'General Health Questionnaire-28 items scores', 'serious adverse events', 'median time spent online', 'mean scores for the General Health Questionnaire-28 items']","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0578884', 'cui_str': 'Cares for a relative'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0282426', 'cui_str': 'Directories'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",800.0,0.183323,"At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03;  p  = 0.027), but this finding is likely to be of limited clinical significance.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lobban', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Akers', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Appelbe', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Iraci Capuccinello', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Chapman', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Lizzi', 'Initials': 'L', 'LastName': 'Collinge', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Flowers', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Hollingsworth', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Honary', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Jones', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Ceu', 'Initials': 'C', 'LastName': 'Mateus', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mezes', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Panagaki', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rainford', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sellwood', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24320']
2095,32608505,Psychological therapies for women who experience intimate partner violence.,"BACKGROUND


Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence-based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm.
OBJECTIVES


To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self-efficacy and an indicator of harm (dropouts) at six- to 12-months' follow-up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support.
SEARCH METHODS


We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature.
SELECTION CRITERIA


We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cross-over trials of psychological therapies with women aged 16 years and older who self-reported recent or lifetime experience of IPV. We included trials if women also experienced co-existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders's psychological therapies list.
DATA COLLECTION AND ANALYSIS


Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short-term (up to six months post-baseline), medium-term (six to under 12 months, primary outcome time point), and long-term follow-up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random-effects meta-analysis, due to high heterogeneity across trials.
MAIN RESULTS


We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face-to-face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials). Whilst 20 trials (61%) described reliable low-risk random-sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status. While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium-term follow-up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence). However, for self-efficacy, there may be no evidence of a difference between groups (SMD -0.12, 95% CI -0.33 to 0.09; one trial with medium-term follow-up data, 346 women; low-certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium-term follow-up data, 840 women; low-certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale. For secondary outcomes, trials measured anxiety only at short-term follow-up, showing that psychological therapies may reduce anxiety symptoms (SMD -0.96, 95% CI -1.29 to -0.63; four trials, 158 women; low-certainty evidence). However, within medium-term follow-up, low-certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI -0.18 to 0.25; one trial, 337 women), post-traumatic stress disorder (SMD -0.24, 95% CI -0.54 to 0.06; four trials, 484 women) or re-exposure to any form of IPV (SMD 0.03, 95% CI -0.14 to 0.2; two trials, 547 women).
AUTHORS' CONCLUSIONS


There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self-efficacy, post-traumatic stress disorder, re-exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow-up time points), as we were unable to synthesise much of the research.",2020,"These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence).","['women who experience intimate partner violence', 'women also experienced co-existing mental health diagnoses or substance abuse issues, or both', '82 women (14 to 479), aged 37 years on average, and 66% were unemployed', 'Intimate partner violence (IPV) against women', 'women who have experienced IPV and have a mental health diagnosis', '33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49', 'Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these', 'Women experiencing IPV attend health services frequently for mental health problems', 'women aged 16 years and older who self-reported recent or lifetime experience of IPV']","['Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions', 'psychological therapies', 'Psychological therapies']","['anxiety symptoms', 'post-traumatic stress disorder', 'emotional health', 'mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support', 'IPV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",5517.0,0.386411,"These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence).","[{'ForeName': 'Mohajer', 'Initials': 'M', 'LastName': 'Hameed', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': ""O'Doherty"", 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Gilchrist', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Tirado-Muñoz', 'Affiliation': ""Addiction Research Group, IMIM-Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'The Judith Lumley Centre, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Chondros', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Feder', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hegarty', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013017.pub2']
2096,32610254,"Antioxidant cocktail following a high-sodium meal does not affect vascular function in young, healthy adult humans: a randomized controlled crossover trial.","Chronic high sodium intake is a risk factor for cardiovascular disease as it impairs vascular function through an increase in oxidative stress. The objective of this study was to investigate the acute effects of a high-sodium meal (HSM) and antioxidant (AO) cocktail on vascular function. We hypothesized that a HSM would impair endothelial function, and increase arterial stiffness and wave reflection, while ingestion of the AO cocktail would mitigate this response. Healthy adults ingested either an AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM (1500 mg) in a randomized crossover blinded design. Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx) were made at baseline and 30, 60, 90, and 120 min after meal consumption. Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study. Mean BP increased at 120 min relative to 60 min (60 min: 79 ± 1; 120 min: 81 ± 1 mmHg; time effect P = .01) but was not different between treatments (treatment × time interaction P = .32). AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31). PWV (treatment × time interaction, P = .91) and FMD (treatment × time interaction P = .65) were also not different between treatments. In conclusion, a HSM does not acutely impair vascular function suggesting young healthy adults can withstand the acute impact of sodium on the vasculature and therefore, the AO cocktail is not necessary to mitigate the response.",2020,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"['young healthy adults', 'young, healthy adult humans', 'Healthy adults ingested either an', 'Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study']","['Antioxidant cocktail following a high-sodium meal', 'HSM', 'AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM', 'high-sodium meal (HSM) and antioxidant (AO) cocktail']","['endothelial function', 'Mean BP', 'FMD', 'Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx', 'vascular function', 'PWV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",,0.120549,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Smiljanec', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ksmilja@udel.edu.'}, {'ForeName': 'Alexis U', 'Initials': 'AU', 'LastName': 'Mbakwe', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ambakwe@udel.edu.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Ramos-Gonzalez', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: macramos@udel.edu.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'Biostatistics Core Facility, University of Delaware, STAR, Newark, DE. Electronic address: rpohlig@udel.edu.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: slennon@udel.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.011']
2097,32610257,Oral vitamin C treatment increases polymorphonuclear cell functions in type 2 diabetes mellitus patients with poor glycemic control.,"This study investigated the effect of vitamin C on polymorphonuclear (PMN) cell functions in type 2 diabetes mellitus patients with poor glycemic control. We hypothesized that oral vitamin C treatment improves PMN cell functions. Patients (14) received either a vitamin C (1000 mg/d) or placebo (anhydrous calcium hydrogen phosphate) tablet for 6 weeks and were subjected to a 6-week washout period followed by a 6-week treatment crossover period. Blood samples were collected at pretreatment and posttreatment for PMN cell functions (by flow cytometry) and plasma vitamin C concentration. Phagocytosis was examined by incubating whole blood samples with fluorescein isothiocyanate-labeled Staphylococcus aureus, and oxidative burst was simultaneously evaluated by adding hydroethidine. In comparison with placebo, vitamin C increased both PMN cell phagocytosis (pretreatment: placebo, 17.8% ± 1.6% and vitamin C, 19.0% ± 3.4%, P = .70; posttreatment: placebo, 16.6% ± 1.7% and vitamin C, 27.1% ± 2.9%, P = .005) and oxidative burst (pretreatment: placebo, 6.4% ± 0.8% and vitamin C, 7.1% ± 1.2%, P = .60; posttreatment: placebo, 6.9% ± 1.3% and vitamin C, 12.1% ± 1.6%, P = .02). The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01). Plasma vitamin C concentration and PMN cell functions were not significantly different before both treatments. We conclude that the 6-week 1000-mg/d vitamin C increased PMN phagocytosis and oxidative burst in type 2 diabetes mellitus patients with poor glycemic control.",2020,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,['type 2 diabetes mellitus patients with poor glycemic control'],"['Oral vitamin C treatment', 'placebo, vitamin C', 'oral vitamin C', 'vitamin C', 'placebo (anhydrous calcium hydrogen phosphate) tablet', 'placebo']","['PMN cell functions', 'polymorphonuclear (PMN) cell functions', 'Plasma vitamin C concentration and PMN cell functions', 'Blood samples', 'PMN cell phagocytosis', 'oxidative burst', 'plasma vitamin C concentration', 'polymorphonuclear cell functions', 'PMN phagocytosis and oxidative burst']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0108134', 'cui_str': 'Calcium phosphate dibasic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0085416', 'cui_str': 'Oxidative Burst'}]",,0.155192,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,"[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Chuangchot', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: nisachuang@kku.ac.th.'}, {'ForeName': 'Chongchira', 'Initials': 'C', 'LastName': 'Boonthongkaew', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chongchira@kkumail.com.'}, {'ForeName': 'Wisitsak', 'Initials': 'W', 'LastName': 'Phoksawat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: wisitsakphok@kkumail.com.'}, {'ForeName': 'Amonrat', 'Initials': 'A', 'LastName': 'Jumnainsong', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: amonrat@kku.ac.th.'}, {'ForeName': 'Chanvit', 'Initials': 'C', 'LastName': 'Leelayuwat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chanvit@kku.ac.th.'}, {'ForeName': 'Naruemon', 'Initials': 'N', 'LastName': 'Leelayuwat', 'Affiliation': 'Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: naruemon@kku.ac.th.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.010']
2098,32614875,Participation in interventions and recommended follow-up for non-attendees in cervical cancer screening -taking the women's own preferred test method into account-A Swedish randomised controlled trial.,"BACKGROUND


Cervical cancer is a highly preventable disease. To not attend an organized cervical cancer screening program increases the risk for cervical dysplasia and cervical cancer. The aim was to investigate the participation rate in three different intervention groups for non- attendees in the Swedish national program for cervical screening. The participation in the recommended follow up, and the histology found were also examined.
METHOD


Population-based randomized control trial. It included10,614 women that had not participated in the cervical cancer screening programme during the last six years (ages 30-49) and the last eight years (ages 50-64) were randomised 1:1:1(telephone call from a midwife (offering the choice between a visit for a pap smear or an HPV self-sampling test); an HPV self-sampling test only; or the routine procedure with a yearly invitation).
RESULTS


In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (p<0.001) for telephone, HPV self-test and control groups respectively. In the by protocol analysis including women that answered the phone call the participation rates were 31.7% (N = 565/1784) vs 26.1% (N = 788/3002) and 7.0% (N = 250/3538) (p<0.001) for telephone, HPV self-test and control groups. The corresponding results in the by protocol analysis including women that did not answer the phone call was 19.7% (N = 565/2870) vs 26.1% (N = 788/3002) and 7.0% (N = 250/3538) (p< 0.001). The majority of the women 63,4% (1131/1784) who answered the telephone wanted to participate either by booking a visit for pap smear (38,5%) or to be sent a HPV self- sampling test (24,9%) (p<0.001). Women who chose an HPV self-test were older and gave anxiety/ fear as a reason to decline participation, and they were also less likely to participate in the follow-up if found to be HPV-positive compared to the women who chose a Pap smear. The attendance to the recommended follow-up after abnormality was in total 87%. The non-attendees had a three or eight times higher risk of having a cytology result of HSIL or suspected SCC respectively, in the index sample compared to women screened as recommended (OR 3.3 CI 95% 1.9-5.2, OR 8.6 CI 1.6-30). A total of ten SCC and one adenocarcinoma were found in the histopathology results from the non-attendee group with a study intervention, while there was only one SCC in the non-attendee group without any study intervention (p = 0.02, OR 8.1 CI 95% 1.2-350).
CONCLUSIONS


Our study suggests, according to intention to treat analysis, that the best intervention to get as many non-attendees as possible to participate is to send an HPV self-sampling test together with an invitation letter. Almost 90% of women in the study with an abnormal index sample attended follow-up. This is high enough to indicate that interventions to increase the participation among non-attendees are meaningful.
REGISTRY


International Standard Randomised Controlled Trial Number (ISRCTN) Registration number ISRCTN78719765.",2020,In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (,"['It included10,614 women that had not participated in the cervical cancer screening programme during the last six years (ages 30-49) and the last eight years (ages 50-64', 'non- attendees in the Swedish national program for cervical screening']","['1:1:1(telephone call from a midwife (offering the choice between a visit for a pap smear or an HPV self-sampling test); an HPV self-sampling test only; or the routine procedure with a yearly invitation', 'organized cervical cancer screening program']","['participation rates', 'participation rate', 'cervical dysplasia and cervical cancer']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1298805', 'cui_str': 'Routine procedure'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007868', 'cui_str': 'Dysplasia of cervix'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",10.0,0.0285619,In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lilliecreutz', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Anna-Clara', 'Initials': 'AC', 'LastName': 'Spetz Holm', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}]",PloS one,['10.1371/journal.pone.0235202']
2099,32614987,Intradermal injection of incobotulinumtoxinA for face lifting.,"Intradermal injection of botulinumtoxinA (BoNT/A) has been used off-label by many clinicians for the purpose of face-lifting effect. Some studies on AbobotulinumtoxinA (AboA) demonstrated clinical efficacy on face-lifting effect when comparing to normal saline solution (NSS). So far, there is no split-face comparison study on face-lifting effect of IncobotulinumtoxinA (IncoA). The objective of this study was to compare the face-lifting effect of IncoA intradermal injection and NSS. Twenty-two subjects were enrolled and randomly injected with IncoA at 1:6 cc dilution (100 unit or 1 vial in 6 cc of NSS) on one side, and NSS on the other side by using intradermal injection technique. Standardized photographic documentation with 2-, and 3-dimentional imaging system (Vectra H1, Canfield Scientific, Inc., Fairfield, NJ) were obtained at baseline, and at 2 weeks after treatment. The face-lifting effect was graded by the subjects and two blinded dermatologists, using photographic comparison. Side effects were also recorded at the end of the study. Immediate face-lifting was identified on the side that was treated with IncoA by blinded injectors in 63.6% of patients. Of all subjects, 17 (77.3%) have noticed the improvement of skin laxity on the side that was treated with IncoA at 2 weeks after treatment. The difference in facial contouring volume measured by Vectra H1 imaging system on IncoA side was significantly higher (P = .033) when comparing to NSS side in patients aged <36 years old. However, there was no statistically significant difference in face-lifting when comparing between IncoA and NSS evaluated by two blinded dermatologists (P = 1.00). Facial asymmetry was found in 36.4% of subjects. This study demonstrated the face-lifting effect of IncoA intradermal injection. Further studies with larger number of subjects and proper method of evaluation should be done to verify these findings.",2020,"Of all subjects, 17 (77.3%) have noticed the improvement of skin laxity on the side that was treated with IncoA at 2 weeks after treatment.",['Twenty-two subjects were enrolled and randomly injected with'],"['IncobotulinumtoxinA', 'IncoA at 1:6 cc dilution (100 unit or 1 vial in 6 cc of NSS', 'botulinumtoxinA', 'IncoA intradermal injection and NSS', 'AbobotulinumtoxinA (AboA']","['Side effects', 'Facial asymmetry', 'skin laxity', 'facial contouring volume']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1720154', 'cui_str': 'Inject'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0546952', 'cui_str': 'Congenital facial asymmetry'}, {'cui': 'C0010495', 'cui_str': 'Cutis laxa'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",22.0,0.0195465,"Of all subjects, 17 (77.3%) have noticed the improvement of skin laxity on the side that was treated with IncoA at 2 weeks after treatment.","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ya-Nin', 'Initials': 'YN', 'LastName': 'Nokdhes', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Poramin', 'Initials': 'P', 'LastName': 'Patthamalai', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Weeranut', 'Initials': 'W', 'LastName': 'Phothong', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand.'}]",Dermatologic therapy,['10.1111/dth.13944']
2100,32615892,[The Effect of a Short-Term Mindfulness Program on Memory Performance in School-Aged Children].,"The Effect of a Short-Term Mindfulness Program on Memory Performance in School-Aged Children  A one-week mindfulness-based intervention designed to improve 8- to 10-year-old children's memory performance was investigated. Seventy-three children were quasi-randomly assigned either to one of two mindfulness-based intervention groups (breathing meditation or yoga), or to an active control group. The sessions were held on six consecutive days. Prior to intervention and after completing the intervention, children's short-term and long-term memory performance were assessed. In confirmation of prior studies, breathing meditation and yoga showed positive effects on memory performance when compared with the control group. Moreover, differences in the effectiveness of breathing meditation and yoga were found: While both interventions had comparable effects on long-term memory, only breathing meditation showed improvements in short-term memory performance. The present study provides valuable evidence on the effectiveness of meditation on cognitive functions in childhood and shows that school-aged children can already benefit from short-term meditation programs.",2020,"In confirmation of prior studies, breathing meditation and yoga showed positive effects on memory performance when compared with the control group.","['School-Aged Children', 'school-aged children', 'Seventy-three children']","['Short-Term Mindfulness Program', 'mindfulness-based intervention groups (breathing meditation or yoga), or to an active control group']","['short-term memory performance', 'memory performance', 'Memory Performance']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0561844', 'cui_str': 'Short-term memory performance'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",73.0,0.0165485,"In confirmation of prior studies, breathing meditation and yoga showed positive effects on memory performance when compared with the control group.","[{'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Möller', 'Affiliation': 'Universität des Saarlandes Campus A1.3 66123 Saarbrücken Deutschland Universität des Saarlandes.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Aschersleben', 'Affiliation': 'Universität des Saarlandes Campus A1.3 66123 Saarbrücken Deutschland Universität des Saarlandes.'}]",Praxis der Kinderpsychologie und Kinderpsychiatrie,['10.13109/prkk.2020.69.4.305']
2101,32639468,"A Randomized, Controlled Pharmacokinetic and Pharmacodynamics Trial of Ambrisentan After Fontan Surgery.","OBJECTIVES


To determine the pharmacokinetics, pharmacodynamics, and safety of the hepatically metabolized endothelin receptor antagonist, ambrisentan in children after Fontan surgery.
DESIGN


Prospective, randomized, double-blind, placebo-controlled pharmacokinetic/pharmacodynamics and safety trial.
SETTING


Single-center, postoperative cardiac ICU.
PATIENTS


Children undergoing elective Fontan surgery.
INTERVENTIONS


Subjects randomized on postoperative day number 1 to short-term (3 d) treatment with oral ambrisentan (2.5 mg in suspension, daily) versus placebo (4:1 randomization).
MEASUREMENTS AND MAIN RESULTS


Plasma drug concentrations were measured at 0.5, 1, 2, 4, and 18-36 hours after the first dose. We developed a population pharmacokinetic model in NONMEM 7.2 (Icon Solutions, Ellicott City, MD) and applied the model to dose-exposure simulations. Pharmacodynamics endpoints were assessed at baseline and 3 hours after study drug administration, using postoperative hemodynamic monitoring lines. The analysis included 16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males. There were no differences in baseline characteristics between ambrisentan and controls. A one-compartment model with first-order absorption and lag-time characterized the data well. Allometrically scaled weight was the only covariate retained in the final model. Typical values for clearance and volume of distribution were lower than previously reported in adults, 1 L/hr/70 kg and 13.7 L/70 kg, respectively. Simulated exposures with doses of 0.1-0.2 mg/kg approximated therapeutic exposures in adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses. Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
CONCLUSIONS


Ambrisentan clearance is reduced following Fontan surgery, perhaps reflecting abnormal hepatic metabolism in this population. The observed safety profile appears favorable and hemodynamic effects of ambrisentan may be beneficial for Fontan patients.",2020,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","['Fontan patients', 'adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses', 'children after Fontan surgery', 'Children undergoing elective Fontan surgery', 'Single-center, postoperative cardiac ICU', '16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males']","['Ambrisentan', 'oral ambrisentan (2.5 mg in suspension, daily) versus placebo', 'placebo']","['Fontan pressures', 'Plasma drug concentrations', 'Typical values for clearance and volume of distribution', 'indexed pulmonary vascular resistance', 'plasma brain natriuretic peptide concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0918012', 'cui_str': 'Indexes as Topic'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",,0.416991,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Anil R', 'Initials': 'AR', 'LastName': 'Maharaj', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Piers C A', 'Initials': 'PCA', 'LastName': 'Barker', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002410']
2102,32639698,A Pilot Randomized Controlled Crossover Trial Comparing Early OHRQoL Outcomes of Cobalt-Chromium Versus PEEK Removable Partial Denture Frameworks.,"PURPOSE


To investigate differences in the performance of polyether ether ketone (PEEK) frameworks vs traditional metal frameworks for removable partial dentures (RPDs) in terms of OHRQoL, patient preference, periodontal indices, and denture satistfaction.
MATERIALS AND METHODS


Twenty-six participants were recruited to a randomized controlled crossover trial and were provided with either PEEK or cobalt-chromium (Co-Cr) RPDs. After 4 weeks, the participants were provided with the other RPD. After both 4-week testing periods, the participants chose their preferred RPD and were followed up again at 6 months and 1 year. The primary outcome measure was effect on OHIP-20 score, which was compared among patients using repeated measures ANOVA. Secondary outcomes were participant preference compared using chi-square analysis; Plaque Index and Gingival Bleeding Index (PI and GBI, respectively) compared using repeated measures ANOVA; and McGill Denture Satisfaction Questionnaire (MDSQ) score compared between the two 4-week follow-ups using paired-samples t test.
RESULTS


Both Co-Cr and PEEK frameworks resulted in a significant improvement in OHIP-20 score (P < .001), but the material was not a significant factor in changes over 1 year (P = .87). There were no statistically significant differences in participant preference at 1 year (P = .491), nor between RPD materials in their effect on GBI (P = .476), PI (P = .967), or MDSQ (P = .368).
CONCLUSION


Both Co-Cr and PEEK RPDs improved OHRQoL to a degree greater than the minimum clinically important difference at 4 weeks, 6 months, and 1 year compared to baseline. No significant preference or improved denture satisfaction score was seen for either material. PEEK frameworks seem to be associated with similar degrees of periodontal effects as Co-Cr frameworks.",2020,"Both Co-Cr and PEEK RPDs improved OHRQoL to a degree greater than the minimum clinically important difference at 4 weeks, 6 months, and 1 year compared to baseline.","['Versus PEEK Removable Partial Denture Frameworks', 'Twenty-six participants']","['PEEK or cobalt-chromium (Co-Cr) RPDs', 'polyether ether ketone (PEEK) frameworks vs traditional metal frameworks', 'Cobalt-Chromium']","['denture satisfaction score', 'GBI', 'OHIP-20 score', 'OHRQoL', 'participant preference compared using chi-square analysis; Plaque Index and Gingival Bleeding Index (PI and GBI, respectively) compared using repeated measures ANOVA; and McGill Denture Satisfaction Questionnaire (MDSQ) score']","[{'cui': 'C0014994', 'cui_str': 'ethyl ether'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0014994', 'cui_str': 'ethyl ether'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0450152', 'cui_str': 'Metal framework'}]","[{'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",26.0,0.142266,"Both Co-Cr and PEEK RPDs improved OHRQoL to a degree greater than the minimum clinically important difference at 4 weeks, 6 months, and 1 year compared to baseline.","[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Ali', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Sereno', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': ''}]",The International journal of prosthodontics,['10.11607/ijp.6604']
2103,32634485,Virtual mind-body treatment for adolescents with neurofibromatosis: Study protocol for a single-blind randomized controlled trial.,"BACKGROUND


Neurofibromatoses (NF) are a group of genetically distinct disorders of the nervous system unified by the predisposition to nerve sheath tumors. Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs. This paper presents the study design and protocol for the first randomized controlled trial (RCT) of a mind-body intervention for adolescents with NF, Resilient Youth with NF (RY-NF), versus an educational control group, Health Education for NF (HE-NF), both delivered in groups via secure live video.
METHODS


This is an ongoing, single-blind efficacy RCT. Recruitment began in November 2019 and will continue until March 2022. We will enroll 200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms. We will use a shared-baseline, linear mixed model to compare the effect of RY-NF versus HE-NF on changes in quality of life (QoL) and psychosocial outcomes from baseline to post-intervention, and 6- and 12-month follow-ups. We will also develop NF-specific minimal clinically important difference (MCID) for QoL variables, and conduct mediation and moderation analyses to understand mechanisms of improvement.
DISCUSSION


This study has important clinical and public health implications for the psychosocial functioning of adolescents with NF. It provides a model for efficient delivery of virtual psychosocial care for adolescents with rare diseases. Plans for dissemination and implementation of the RY-NF should efficacy be ascertained are also discussed.",2020,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","['adolescents with NF, Resilient Youth with NF (RY-NF', 'adolescents with neurofibromatosis', 'adolescents with NF', 'adolescents with rare diseases', '200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms']","['educational control group, Health Education for NF (HE-NF', 'Virtual mind-body treatment', 'mind-body intervention', 'RY-NF versus HE-NF']",['quality of life (QoL) and psychosocial outcomes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0678236', 'cui_str': 'Rare Diseases'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0582154', 'cui_str': 'Difficulty coping'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0666435,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Reichman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: mreichman@mgh.harvard.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Riklin', 'Affiliation': 'Department of Psychology, Fordham University, Dealy 336, 441 East Fordham Rd, Bronx, NY 10458, United States of America. Electronic address: eriklin@fordham.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, 50 Staniford Street, St 560, Boston, MA 02114, United States of America. Electronic address: emacklin@mgh.harvard.edu.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America; Harvard Medical School, One Bowdoin Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: avranceanu@mgh.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106078']
2104,32634745,"Examining sex, adverse childhood experiences, and oxytocin on neuroendocrine reactivity in smokers.","Adverse childhood experiences (ACE) are associated with greater neuroendocrine responses to social stress in substance users. The neuropeptide oxytocin might attenuate this relationship. Given sex differences in ACE exposure and neuroendocrine stress reactivity, it is unknown whether this association is similar for males and females. Therefore, this secondary analysis evaluated the interactive effect of sex, ACE, and acute oxytocin administration on neuroendocrine stress responses in adult cigarette smokers (N = 144). Participants completed the Adverse Childhood Experiences Questionnaire at screening and were randomized to receive intranasal oxytocin or placebo before undergoing the Trier Social Stress Task (TSST). Cortisol levels were assessed at pre- and post-medication administration and at 20 and 40 min following the TSST. Generalized linear mixed models were developed to predict post-TSST cortisol levels. Predictors included treatment assignment (placebo vs. oxytocin), sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration. The hypothesized three-way interaction between sex, oxytocin, and ACE scores was significant. Linear associations between ACE scores and cortisol reactivity indicated higher ACE scores were associated with attenuated cortisol response in females, regardless of treatment condition. For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin. Results indicate that the association between ACE and neuroendocrine reactivity to social stress, as well as the attenuating effect of oxytocin, is differentially impacted by sex. Males with greater childhood adversity may be more likely to benefit from oxytocin's anxiolytic properties.",2020,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","['adult cigarette smokers (N\u2009=\u2009144', 'smokers', 'Participants completed the Adverse Childhood Experiences Questionnaire at screening']","['oxytocin', 'treatment assignment (placebo vs. oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin or placebo', 'oxytocin administration']","['sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration', 'cortisol response', 'ACE scores', 'Cortisol levels', 'ACE scores and cortisol reactivity indicated higher ACE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4284014', 'cui_str': 'Adverse Childhood Experience questionnaire'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0291417,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, United States. Electronic address: caitlyn.hood@uky.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Breanna M', 'Initials': 'BM', 'LastName': 'Tuck', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, United States.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States; Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104752']
2105,32634760,Effect of dose-dense adjuvant chemotherapy in hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype: an exploratory analysis of the GIM2 trial.,"BACKGROUND


Luminal A-like and luminal B-like subtypes have different sensitivity to (neo)adjuvant chemotherapy, but their role in predicting dose-dense (DD) efficacy in the high-risk setting is unknown. In this exploratory analysis of the Gruppo Italiano Mammella 2 (GIM2) trial, we investigated DD efficacy according to luminal-like subtypes.
METHODS


Patients with node-positive early breast cancer were randomised to receive either DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel. In our analysis, luminal A-like cohort was identified as having a Ki67 < 20% and a progesterone receptor (PgR) ≥ 20%; luminal B-like cohort as having a Ki67 ≥ 20% and/or a PgR < 20%.
RESULTS


Out of 2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer. After a median follow-up of 7.9 years, disease-free survival (DFS) was 80.8% (95% confidence interval [CI] 76.4-84.5) and 70.5% (66.5-74.2) in luminal A-like and luminal B-like cohorts; overall survival (OS) was 91.6% (88.2-94.1) and 85.1% (81.7-87.9), respectively. We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively). When DD efficacy was investigated separately in each cohort, luminal-B like cohort appeared to benefit more from the DD schedule both in terms of DFS (unadjusted hazard ratio [HR] 0.72 [95% CI 0.54-0.96]) and OS (unadjusted HR 0.61 [95% CI 0.40-0.94]), compared with the luminal A-like cohort (unadjusted HR for DFS 0.89 [95% CI 0.59-1.33]; unadjusted HR for OS 0.83 [95% CI 0.45-1.54]).
CONCLUSIONS


No significant interaction between luminal-like subtype and treatment was observed. Patients in the luminal B-like cohort seemed to benefit more from DD schedule.",2020,"We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively).","['2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer', 'Patients with node-positive early breast cancer', 'hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype']","['DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel', 'progesterone receptor (PgR', 'dose-dense adjuvant chemotherapy']","['overall survival (OS', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",2003.0,0.206045,"We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively).","[{'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Carrer de Rosselló, 149, 08036, Barcelona, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bruzzone', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Medical Oncology Department, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Breast Unit, Istituto Nazionale Tumori-Fondazione ""G. Pascale"", Via Mariano Semmola, 53, 80131, Naples, NA, Italy.'}, {'ForeName': 'Enrichetta', 'Initials': 'E', 'LastName': 'Valle', 'Affiliation': 'Department of Medical Oncology, Ospedale Businco, Via Edward Jenner, 1, 09121, Cagliari, CA, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cognetti', 'Affiliation': 'Department of Clinical and Molecolar Medicine, La Sapienza University, Viale Regina Elena, 324, 00161, Rome, RM, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nisticò', 'Affiliation': 'Department of Medical Oncology 1, Istituto Nazionale Tumori ""Regina Elena"", Via Elio Chianesi, 53, 00128, Rome, RM, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Sergio Pansini, 5, 80131, Naples, NA, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Garrone', 'Affiliation': 'Breast Unit, Department of Oncology, Azienda Ospedaliera Santa Croce e Carle, Via Michele Coppino, 26, 12100, Cuneo, CN, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gamucci', 'Affiliation': 'Department of Medical Oncology, Ospedale Sandro Pertini, Via dei Monti Tiburtini, 385/389, 00157, Rome, RM, Italy; Department of Medical Oncology, Ospedale SS Trinità, Località San Marciano, 03039, Sora, FR, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montemurro', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Strada Provinciale, 142, 10060, Turin, TO, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Puglisi', 'Affiliation': 'Department of Medicine, University of Udine, Piazzale Massimiliano Kolbe, 4, 33100, Udine, Italy; Department of Medical Oncology, IRCCS Centro di Riferimento Oncologico Aviano - National Cancer Institute, Via Franco Gallini, 2, 33081, Aviano, PN, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cardinali', 'Affiliation': 'Breast Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostic (DISC), University of Genova, Viale Benedetto XV, 6, 1612, Genoa, GE, Italy; Department of Surgery, IRCCS Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Miglietta', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Medical Oncology Department, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Ceppi', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy; Breast Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy. Electronic address: lucia.delmastro@hsanmartino.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.007']
2106,32635933,Stepped-wedge cluster randomised trial of a smoking cessation counselling training programme for midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE): a study protocol.,"BACKGROUND


In the Netherlands, midwives are required to use the 'V-MIS' (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol to help pregnant women quit smoking. This counselling protocol is often poorly implemented in midwifery practices. It may also be less suitable for pregnant woman with low socioeconomic status or functional health illiteracy. We created an adapted version of the V-MIS protocol that is intended to facilitate implementation in midwifery practices: PROMISE (PROtocol for growing up smokefree using a Minimal smoking cessation Intervention Strategy in the Early stages of life). For this adapted protocol, midwives use carbon monoxide meters, storyboard leaflets, and specific communication techniques for women with functional health illiteracy. They will receive a face-to-face training in using these materials and communication techniques.
METHODS


The effectiveness and implementation of PROMISE will be tested in a stepped-wedge cluster randomised controlled trial. We will randomise clusters of midwifery practices and departments in hospitals. We will then train them, subsequently, at regular intervals ('steps'). At each step, practices that will receive training cross over from the control condition to the experimental condition. We will measure how well the PROMISE protocol has been implemented by assessing the rate of pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome). Our secondary target group is pregnant women with functional health illiteracy and low socioeconomic status. Among them, we will assess smoking status and health-related outcome before and after pregnancy.
DISCUSSION


The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.
TRIAL REGISTRATION


Dutch Trial Registry: NTR 6305/NL6158 . Registered on 20 December 2016.",2020,"The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.
","['midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE', 'pregnant women with functional health illiteracy and low socioeconomic status', 'pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome', 'women with functional health illiteracy', 'pregnant women with smoking cessation', 'pregnant woman with low socioeconomic status or functional health illiteracy', 'midwifery practices and departments in hospitals']","[""MIS' (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol"", 'smoking cessation counselling training programme']",[],"[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.125279,"The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.
","[{'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Bommelé', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands. jbommele@trimbos.nl.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Springvloet', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Naïma', 'Initials': 'N', 'LastName': 'Abouri', 'Affiliation': 'Pharos, Utrecht, the Netherlands.'}, {'ForeName': 'Karianne', 'Initials': 'K', 'LastName': 'Djoyoadhiningrat-Hol', 'Affiliation': 'Lung Foundation Netherlands, Amersfoort, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'van Laar', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}]",Trials,['10.1186/s13063-020-04555-0']
2107,32599274,Family nurture intervention alters relationships between preterm infant EEG delta brush characteristics and term age EEG power.,"OBJECTIVE


Family Nurture Intervention (FNI) facilitates mother/infant emotional connection, improves neurodevelopmental outcomes and increases electroencephalogram (EEG) power at term age. Here we explored whether delta brushes (DB), early EEG bursts that shape brain development, are altered by FNI and mediate later effects of FNI on EEG.
METHODS


We assessed DB characteristics in EEG data from a randomized controlled trial comparing infants with standard care (SC, n = 31) versus SC + FNI (n = 33) at ~35 and ~40 weeks GA.
RESULTS


Compared to SC infants, FNI infant DB amplitude increased more from ~35 to ~40 weeks, and FNI infants had longer duration DBs. DB parameters (rate, amplitude, brush frequency) at ~35 weeks were correlated with power at ~40 weeks, but only in SC infants. FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term.
CONCLUSIONS


DBs are related to subsequent brain activity and FNI alters DB parameters. However, FNI's effects on electrocortical activity at term age are not dependent on its earlier effects on DBs.
SIGNIFICANCE


While early DBs can have important effects on later brain activity in preterm infants, facilitating emotional connection with FNI may allow brain maturation to be less dependent on early bursts.",2020,"FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term.
","['infants with standard care (SC, n\xa0=\xa031) versus', 'preterm infants']","['Family nurture intervention', 'SC\xa0+\xa0FNI']","['neurodevelopmental outcomes and increases electroencephalogram (EEG', 'FNI infant DB amplitude', 'DB parameters (rate, amplitude, brush frequency', 'longer duration DBs', 'electrocortical activity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0522774,"FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term.
","[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Welch', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA. Electronic address: mgw13@columbia.edu.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Grieve', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: pgg3@columbia.edu.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Barone', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: JB3908@columbia.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ludwig', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: rjl2128@columbia.edu.'}, {'ForeName': 'Raymond I', 'Initials': 'RI', 'LastName': 'Stark', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: ris2@columbia.edu.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Isler', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: jri2101@columbia.edu.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Myers', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA. Electronic address: mmm3@columbia.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.05.020']
2108,32600140,Negative pressure wound therapy versus conventional dressing for open fractures in lower extremity trauma.,"AIMS


It has been generally accepted that open fractures require early skeletal stabilization and soft-tissue reconstruction. Traditionally, a standard gauze dressing was applied to open wounds. There has been a recent shift in this paradigm towards negative pressure wound therapy (NPWT). The aim of this study was to compare the clinical outcomes in patients with open tibial fractures receiving standard dressing versus NPWT.
METHODS


This multicentre randomized controlled trial was approved by the ethical review board of a public sector tertiary care institute. Wounds were graded using Gustilo-Anderson (GA) classification, and patients with GA-II to III-C were included in the study. To be eligible, the patient had to present within 72 hours of the injury. The primary outcome of the study was patient-reported Disability Rating Index (DRI) at 12 months. Secondary outcomes included quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates at 12 months. Logistic regression analysis and independent-samples  t- test were applied for secondary outcomes. Analyses of primary and secondary outcomes were performed using SPSS v. 22.0.1 and p-values of < 0.05 were considered significant.
RESULTS


A total of 486 patients were randomized between January 2016 and December 2018. Overall 206 (49.04%) patients underwent NPWT, while 214 (50.95%) patients were allocated to the standard dressing group. There was no statistically significant difference in DRI at 12 months between NPWT and standard dressing groups (mean difference 0.5; 95% confidence interval (CI) -0.08 to 1.1; p = 0.581). Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781). The 30-day deep infection rate was slightly higher in the standard gauze dressing group. The non-union odds were also comparable (odds ratio (OR) 0.90, 95% CI 0.56 to 1.45; p = 0.685).
CONCLUSION


Our study concludes that NPWT therapy does not confer benefit over standard dressing technique for open fractures. The DRI, SF-12 scores, wound infection, and nonunion rates were analogous in both study groups. We suggest surgeons continue to use cheaper and more readily available standard dressings. Cite this article:  Bone Joint J  2020;102-B(7):912-917.",2020,"Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781).","['open fractures in lower extremity trauma', 'patients with open tibial fractures receiving standard dressing versus NPWT', '486 patients were randomized between January 2016 and December 2018', 'patients with GA-II to III-C were included in the study']","['standard gauze dressing', 'Negative pressure wound therapy versus conventional dressing', 'NPWT therapy']","['30-day deep infection rate', 'DRI, SF-12 scores, wound infection, and nonunion rates', 'DRI', 'quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates', 'patient-reported Disability Rating Index (DRI', 'SF-12 scores']","[{'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1998495', 'cui_str': 'Gauze dressing'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",486.0,0.0966509,"Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781).","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Tahir', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Ejaz A', 'Initials': 'EA', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Orthopaedics, Ghurkhi Trust Hospital, Lahore, Pakistan.'}, {'ForeName': 'Faridullah K', 'Initials': 'FK', 'LastName': 'Zimri', 'Affiliation': 'Department of Orthopaedics, National Institute of Rehabilitation Medicine, Islamabad, Pakistan.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Saeed A', 'Initials': 'SA', 'LastName': 'Shaikh', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Shoaib', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Orthopaedics, Whiston Hospital, Prescot, United Kingdom.'}, {'ForeName': 'Usama K', 'Initials': 'UK', 'LastName': 'Choudry', 'Affiliation': 'Shifa International Hopsital, Islamabad, Pakistan.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Aziz', 'Affiliation': 'Department of Orthopaedics, Ghurkhi Trust Hospital, Lahore, Pakistan.'}, {'ForeName': 'Allah R', 'Initials': 'AR', 'LastName': 'Jamali', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}]",The bone & joint journal,['10.1302/0301-620X.102B7.BJJ-2019-1462.R1']
2109,32600149,Operative repair of acute Achilles tendon rupture does not give superior patient-reported outcomes to nonoperative management.,"AIMS


The aim was to compare long-term patient-reported outcome measures (PROMs) after operative and nonoperative treatment of acute Achilles tendon rupture in the context of a randomized controlled trial.
METHODS


PROMs including the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates were collected for patients randomized to receive either operative or nonoperative treatment for acute Achilles tendon rupture in a previous study. Of the 80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively) patients were followed up at a mean of 15.7 years (13.4 to 17.7).
RESULTS


There was no statistically significant difference between operatively and nonoperatively treated patients, in SMFA Dysfunction Index (median 1.56 (interquartile range (IQR) 0 to 5.51) vs 1.47 (IQR 0 to 5.15); p = 0.289), SMFA Bother Index (2.08 (IQR 0 to 12.50) vs 0.00 (IQR 0 to 6.25); p = 0.074), ATRS (94 (IQR 86 to 100) vs 95 (IQR 81 to 100); p = 0.313), EQ-5D-5L (1 (IQR 0.75 to 1) vs 1 (IQR 0.84 to 1); p = 0.137) or EQ-5D health today visual analogue score (85 (IQR 72.5 to 95) vs 85 (IQR 8 to 95); p = 0.367). There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255). Four nonoperative patients and two in the operative group sustained a re-rupture (p = 0.306).
CONCLUSION


Both patient groups reported good results at long-term follow-up. The findings give no evidence of superior long-term patient reported outcomes (as measured by the SMFA) for surgical treatment over nonoperative treatment. There was no demonstrable difference in other patient reported outcome measures, satisfaction, or re-rupture rates at long-term follow-up. Cite this article:  Bone Joint J  2020;102-B(7):933-940.",2020,There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255).,"['80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively']",['operative or nonoperative treatment'],"['EQ-5D health today visual analogue score', 'SMFA Dysfunction Index', 'SMFA Bother Index', 'satisfaction, or re-rupture rates', 'satisfaction', 're-rupture', 'Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates', 'EQ-5D-5L', 'ATRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",4.0,0.115483,There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255).,"[{'ForeName': 'Julian F', 'Initials': 'JF', 'LastName': 'Maempel', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Clement', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Wickramasinghe', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Duckworth', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Keating', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}]",The bone & joint journal,['10.1302/0301-620X.102B7.BJJ-2019-0783.R3']
2110,32609084,Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.,"BACKGROUND


Progesterone is essential for a healthy pregnancy. Several small trials have suggested that progesterone therapy may rescue a pregnancy in women with early pregnancy bleeding, which is a symptom that is strongly associated with miscarriage.
OBJECTIVES


(1) To assess the effects of vaginal micronised progesterone in women with vaginal bleeding in the first 12 weeks of pregnancy. (2) To evaluate the cost-effectiveness of progesterone in women with early pregnancy bleeding.
DESIGN


A multicentre, double-blind, placebo-controlled, randomised trial of progesterone in women with early pregnancy vaginal bleeding.
SETTING


A total of 48 hospitals in the UK.
PARTICIPANTS


Women aged 16-39 years with early pregnancy bleeding.
INTERVENTIONS


Women aged 16-39 years were randomly assigned to receive twice-daily vaginal suppositories containing either 400 mg of progesterone or a matched placebo from presentation to 16 weeks of gestation.
MAIN OUTCOME MEASURES


The primary outcome was live birth at ≥ 34 weeks. In addition, a within-trial cost-effectiveness analysis was conducted from an NHS and NHS/Personal Social Services perspective.
RESULTS


A total of 4153 women from 48 hospitals in the UK received either progesterone ( n  = 2079) or placebo ( n  = 2074). The follow-up rate for the primary outcome was 97.2% (4038 out of 4153 participants). The live birth rate was 75% (1513 out of 2025 participants) in the progesterone group and 72% (1459 out of 2013 participants) in the placebo group (relative rate 1.03, 95% confidence interval 1.00 to 1.07;  p  = 0.08). A significant subgroup effect (interaction test  p  = 0.007) was identified for prespecified subgroups by the number of previous miscarriages: none (74% in the progesterone group vs. 75% in the placebo group; relative rate 0.99, 95% confidence interval 0.95 to 1.04;  p  = 0.72); one or two (76% in the progesterone group vs. 72% in the placebo group; relative rate 1.05, 95% confidence interval 1.00 to 1.12;  p  = 0.07); and three or more (72% in the progesterone group vs. 57% in the placebo group; relative rate 1.28, 95% confidence interval 1.08 to 1.51;  p  = 0.004). A significant post hoc subgroup effect (interaction test  p  = 0.01) was identified in the subgroup of participants with early pregnancy bleeding and any number of previous miscarriage(s) (75% in the progesterone group vs. 70% in the placebo group; relative rate 1.09, 95% confidence interval 1.03 to 1.15;  p  = 0.003). There were no significant differences in the rate of adverse events between the groups. The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms. Thus, the incremental cost-effectiveness ratio of progesterone compared with placebo was estimated as £3305 per additional live birth at ≥ 34 weeks of gestation.
CONCLUSIONS


Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with threatened miscarriage overall, but an important subgroup effect was identified. A conclusion on the cost-effectiveness of the PRISM trial would depend on the amount that society is willing to pay to increase the chances of an additional live birth at ≥ 34 weeks. For future work, we plan to conduct an individual participant data meta-analysis using all existing data sets.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN14163439, EudraCT 2014-002348-42 and Integrated Research Application System (IRAS) 158326.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 33. See the NIHR Journals Library website for further project information.",2020,"The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms.","['women with early pregnancy bleeding', 'women with early pregnancy vaginal bleeding', 'Women aged 16-39 years', '4153 women from 48 hospitals in the UK received either', 'A total of 48 hospitals in the UK', 'women with vaginal bleeding in the first 12 weeks of pregnancy', 'Women aged 16-39 years with early pregnancy bleeding']","['twice-daily vaginal suppositories containing either 400\u2009mg of progesterone or a matched placebo', 'progesterone', 'progesterone therapy', 'vaginal micronised progesterone', 'Progesterone therapy', 'Progesterone', 'placebo']","['rate of live births', 'rate of adverse events', 'incremental cost-effectiveness ratio of progesterone', 'early pregnancy bleeding and any number of previous miscarriage(s', 'live birth at ≥\u200934 weeks', 'live birth rate', 'cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156604', 'cui_str': 'Haemorrhage in early pregnancy, unspecified'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1136199', 'cui_str': 'Vaginal pessary'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0156604', 'cui_str': 'Haemorrhage in early pregnancy, unspecified'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}]",4153.0,0.68774,"The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms.","[{'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Hoda M', 'Initials': 'HM', 'LastName': 'Harb', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Devall', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Chidubem B', 'Initials': 'CB', 'LastName': 'Ogwulu', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Williams', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ioannis D', 'Initials': 'ID', 'LastName': 'Gallos', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Abey', 'Initials': 'A', 'LastName': 'Eapen', 'Affiliation': 'Carver College of Medicine, University of Iowa Health Care, Iowa City, IA, USA.'}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': ""Faculty of Medicine and Health Sciences, Queen's Medical Centre, University of Nottingham, Nottingham, UK.""}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bender-Atik', 'Affiliation': 'Miscarriage Association, Wakefield, UK.'}, {'ForeName': 'Kalsang', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's, London, UK.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Choudhary', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Crosfill', 'Affiliation': 'Royal Preston Hospital, Lancashire Teaching Hospitals NHS Trust, Preston, UK.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'W Colin', 'Initials': 'WC', 'LastName': 'Duncan', 'Affiliation': ""Medical Research Council Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ewer', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holland', 'Affiliation': ""St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Izzat', 'Affiliation': 'University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Johns', 'Affiliation': ""King's College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mary-Ann', 'Initials': 'MA', 'LastName': 'Lumsden', 'Affiliation': 'Reproductive & Maternal Medicine, School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Manda', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': ""Medical Research Council Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nunes', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Isleworth, UK.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Overton', 'Affiliation': ""St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.""}, {'ForeName': 'Kathiuska', 'Initials': 'K', 'LastName': 'Kriedt', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Biomedical Research Unit in Reproductive Health, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': ""Whiston Hospital, St Helen's and Knowsley Teaching Hospitals NHS Trust, Prescot, UK.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ""King's College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'Whipps Cross Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Princess Royal Hospital, Shrewsbury and Telford Hospital NHS Trust, Telford, UK.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Vaithilingham', 'Affiliation': 'Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Watkins', 'Affiliation': ""Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wykes', 'Affiliation': 'East Surrey Hospital, Surrey and Sussex Healthcare NHS Trust, Redhill, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': ""Medical Research Council Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Jurkovic', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24330']
2111,32613871,"The comparison between pulmonary rehabilitation with music therapy and pulmonary rehabilitation alone on respiratory drive, cortisol level and asthma control in patients hospitalized with asthma exacerbation.","INTRODUCTION


Much emphasis is being placed on the role of music therapy as an easy-to-use, noninvasive and relatively cheap method of asthma treatment. The objective of this interventional double-blinded randomized controlled trial was to assess whether music therapy, as a complementary modality to pulmonary rehabilitation, can help to improve respiratory drive, asthma control and quality of life in patients with asthma exacerbation.
METHODS


Hospitalized patients with asthma exacerbation enrolled in the study were randomly assigned to experimental (music therapy) or control (popular science program) group. Both groups during hospitalization received standard pharmacotherapy accompanied by respiratory physiotherapy. Respiratory drive, asthma control, quality of life and serum cortisol in all participants were assessed at the beginning and at the end of their hospitalizations.
RESULTS


The experimental group consisted of 39 asthmatics and 34 subjects with asthma were assigned to the control group. During the hospitalization, the levels of the inspiratory occlusion pressure for the first 0.1 s of inspiration (P0.1) decreased ( p  = 0.004) and the maximum P0.1 increased ( p  = 0.041) only in the experimental group. The serum cortisol level decreased in both groups ( p  = 0.001). The changes in asthma control and quality of life did not reach significant levels in either subject group.
CONCLUSION


Passive music therapy and its effects on the mental state of patients seem to improve the efficiency of the respiratory system. The results of this experimental study demonstrate that a complementary music therapy has beneficial effects on the treatment of asthma exacerbations in adults.",2020,The serum cortisol level decreased in both groups (p = 0.001).,"['Hospitalized patients with asthma exacerbation enrolled in the study', 'patients with asthma exacerbation', 'patients hospitalized with asthma exacerbation', '39 asthmatics and 34 subjects with asthma', 'asthma exacerbations in adults']","['standard pharmacotherapy accompanied by respiratory physiotherapy', 'music therapy and pulmonary rehabilitation alone', 'complementary music therapy', 'experimental (music therapy) or control (popular science programme', 'music therapy', 'Passive music therapy']","['levels of the inspiratory occlusion pressure', 'serum cortisol level', 'Respiratory drive, asthma control, quality of life and serum cortisol', 'asthma control and quality of life', 'respiratory drive, asthma control and quality of life', 'respiratory drive, cortisol level and asthma control', 'maximum P0.1']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",39.0,0.0273043,The serum cortisol level decreased in both groups (p = 0.001).,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Śliwka', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Kaszuba', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Piliński', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Pieniążek', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Department of Clinical Rehabilitation, University School of Physical Education, Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Batkiewicz', 'Affiliation': 'Doctoral School in Medical and Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Marciniak', 'Affiliation': 'Department of Pulmonology, Jagiellonian University Hospital, Kraków, Poland.'}, {'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Bochenek', 'Affiliation': 'University Department of Internal Medicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Nowobilski', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1789874']
2112,32609647,The particulars of certain drugs' effect on the endogenous coenzyme Q10 plasma level in patients with cardiovascular diseases.,"Objectives Coenzyme Q10 (CoQ10) has many vital functions in human body and its endogenous level can be affected either by various diseases or by administrated drugs. This study reveals the effect of atorvastatin, amlodipine and ethoxidol on the endogenous CoQ10 plasma concentration. Methods It was determined the total plasma concentration of endogenous CoQ10 in the plasma of 54 healthy individuals and 62 patients with cardiovascular diseases during treatment with various drugs using high performance liquid chromatography with mass spectrometric detection (HPLC-MS/MS). Results It was found that CoQ10 plasma concentration in patients is statistically significantly lower (on average -49.0 Δ%) than in practically healthy individuals. The total CoQ10 plasma level in patients receiving atorvastatin in the complex therapy is statistically significantly lower (-15.2 Δ%), and in patients taking amlodipine or ethoxidol is statistically significantly higher (+18.2 and +20.2 Δ%, respectively) than in patients of control groups (a group of patients who receive the same drugs, except for the studied one). Conclusions The study showed that in patients with CVDs treated with various drugs the CoQ10 plasma level is statistically significantly lower than in practically healthy individuals. So, to avoid the adverse reactions connected with low CoQ10 plasma levels, it is recommended to adjust the therapy to maintain its constant level.",2020,It was found that CoQ10 plasma concentration in patients is statistically significantly lower (on average -49.0 Δ%) than in practically healthy individuals.,"['54 healthy individuals and 62 patients with cardiovascular diseases', 'patients with cardiovascular diseases']","['atorvastatin', 'atorvastatin, amlodipine and ethoxidol', 'amlodipine', 'Objectives Coenzyme Q10 (CoQ10']","['total plasma concentration of endogenous CoQ10', 'total CoQ10 plasma level', 'CoQ10 plasma level', 'CoQ10 plasma concentration', 'endogenous coenzyme Q10 plasma level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",54.0,0.0159371,It was found that CoQ10 plasma concentration in patients is statistically significantly lower (on average -49.0 Δ%) than in practically healthy individuals.,"[{'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Shikh', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Vladlena', 'Initials': 'V', 'LastName': 'Zozina', 'Affiliation': 'I M Sechenov First Moscow State Medical University, Russian Federation.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Kondratenko', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Melnikov', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kukes', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}]",Drug metabolism and personalized therapy,['10.1515/dmpt-2020-0106']
2113,32609733,Sex-related impairment and patient needs/benefits in anogenital psoriasis: Difficult-to-communicate topics and their impact on patient-centred care.,"Genital psoriasis affects 2-5% of psoriasis patients; generalised plaque or intertriginous psoriasis also affects the genital area in 29-40% of cases. Anogenital psoriasis has been associated with significant quality of life impairments, but little is known about specific patient needs/treatment goals. This study aimed to examine the overall and sex-related disease burden, patient needs and treatment benefits in patients with anogenital psoriasis, compared to patients with psoriasis not affecting the anal/genital areas. Within the cross-sectional nationwide survey, 2,009 participants were consecutively recruited in 157 randomly assigned German dermatology practices and clinics, according to the following inclusion criteria aged 18 years or over; diagnosis of psoriasis vulgaris; ability to answer the questionnaires; and written informed consent. Based on a high-resolution grid on the topical distribution of psoriasis, two groups were formed: anogenital psoriasis (n = 622) and comparison group (n = 1,303). Clinical severity was assessed by the Psoriasis Area and Severity Index (PASI). Patients completed the EuroQoL visual analogue scale (EQ VAS), the Dermatology Life Quality Index (DLQI), and the Patient Benefit Index (PBI). Patients with anogenital psoriasis had higher PASI (13.0±10.6 vs. 8.9±7.6, P < 0.001) and more DLQI impairments (8.9±6.9 vs. 7.0±6.2, P = 0.002) than controls. At the item-level, they also reported more sex-related DLQI impairments (DLQI-i9: 0.5±0.8 vs. 0.3±0.7, P < 0.001) and treatment needs (PBI-i17: 2.2±1.8 vs. 1.9±1.8, P = 0.001). A great percentage of missing/not-relevant responses was found for sex-related items (23.3-41.9%). These results suggest that the assessment of sex-related impairments and treatment needs should be prioritised in patients with anogenital psoriasis. Questionnaires may be used as a less uncomfortable way for patients to discuss their genital lesions and sexual function during healthcare visits. However, the great percentage of missing/not-relevant responses to sex-related items calls for in-depth assessments and effective patient-physician communication regarding these sensitive topics.",2020,"Patients with anogenital psoriasis had higher PASI (13.0±10.6 vs. 8.9±7.6, P < 0.001) and more DLQI impairments (8.9±6.9 vs. 7.0±6.2, P = 0.002) than controls.","['2,009 participants were consecutively recruited in 157 randomly assigned German dermatology practices and clinics, according to the following inclusion criteria aged 18 years or over; diagnosis of psoriasis vulgaris', 'patients with anogenital psoriasis, compared to patients with psoriasis not affecting the anal/genital areas', 'patients with anogenital psoriasis']",[],"['Psoriasis Area and Severity Index (PASI', 'PASI', 'EuroQoL visual analogue scale (EQ VAS), the Dermatology Life Quality Index (DLQI), and the Patient Benefit Index (PBI', 'plaque or intertriginous psoriasis', 'DLQI impairments']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4303296', 'cui_str': 'Psoriasis of anogenital region'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],"[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205268', 'cui_str': 'Intertriginous'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",2009.0,0.0239389,"Patients with anogenital psoriasis had higher PASI (13.0±10.6 vs. 8.9±7.6, P < 0.001) and more DLQI impairments (8.9±6.9 vs. 7.0±6.2, P = 0.002) than controls.","[{'ForeName': 'Neuza', 'Initials': 'N', 'LastName': 'da Silva', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Langenbruch', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Centre Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Division of Dermatology and Venereology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kirsten', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Danckworth', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sommer', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}]",PloS one,['10.1371/journal.pone.0235091']
2114,32614625,First-time handling of different inhalers by chronic obstructive lung disease patients.,"Background:  There is a lack of guidance on inhaler device selection and how to individualize inhaler choice when prescribed for the first-time. Aim of the work:  To compare different inhalers regarding ease of use and number of counseling attempts needed for correct handling in subjects with a first experience to such inhalers; also, to investigate if there is a correlation between total correct steps achievements and patient demographics/clinical variables. Method:  An open-label, non-drug interventional, cross-over study was conducted including 180 Egyptian patients with chronic obstructive pulmonary disease (COPD). The study evaluated handling of the most common inhalers in subjects with a first experience with them before hospital discharge. Subjects were randomized to handle 10 placebo inhalers including: [metered dose inhaler (pMDI), Aerolizer, Handihaler, Turbohaler, Diskus, Breezhaler, Ellipta, Easyhaler, Diskhaler, and Respimat] without receiving verbal or demonstrative instruction with allowable access to the patient information leaflets in native language supported by figures with enough time to read (baseline assessment). Subjects were then crossed-over to other inhalers with a first experience randomly. Inhalers with a reported past-experience were excluded. Inhaler-technique was assessed by using previously defined checklists, including essential steps and critical errors. The whole handling of the inhaler was demonstrated and the number of counseling attempts needed to correct handling was recorded. Patient demographics and clinical variables were recorded and correlated with correct handling steps. Results:  The baseline percentages of total correct steps achievements as mean ± SD were 50 ± 19, 52 ± 16, 58 ± 14, 60 ± 17, 64 ± 10, 67 ± 16, 72 ± 17, 73 ± 11, 77 ± 14 and 86 ± 11% for Respimat, pMDI, Diskhaler, Diskus, Aerolizer, Handihaler, Easyhaler, Turbohaler, Breezhaler, and Ellipta respectively with p < 0.001. Baseline percentages of participants with at least 1 critical error significantly differed between inhalers (p < 0.05) with Ellipta showing the lowest percentage (37%). pMDI, Diskhaler, and Respimat showed the highest percentages (100%, 97% and 94% respectively). The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05). Ellipta showed the highest percentage of participants with correct handling with no counseling (20%) and the highest percentage of participants achieved with one counseling attempt (78%). Diskhaler, pMDI, and Respimat were the only inhalers included in a fourth counseling attempt (15%, 9%, and 6% respectively). Weak and very weak correlations were found between patient demographics/clinical variables and percentages of total correct steps achievements. Conclusion:  Inhalers techniques greatly vary in their ease of use (self-explaining) ranging from easy inhalers (Ellipta) to intermediate inhalers (breezhaler, Easyhaler, Turbohaler, Aerolizer, Handihaler, and Diskus) followed by the most difficult inhalers (pMDI, Diskhaler, and Respimat). That must be considered when prescribing inhalers for the first time; choice of the inhaler should, in part, be based on ease of use and to be accompanied by repeated counseling.",2020,The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05).,"['chronic obstructive lung disease patients', 'subjects with a first experience with them before hospital discharge', 'subjects with a first experience to such inhalers', '180 Egyptian patients with chronic obstructive pulmonary disease (COPD']","['placebo inhalers including: [metered dose inhaler (pMDI), Aerolizer, Handihaler, Turbohaler, Diskus, Breezhaler, Ellipta, Easyhaler, Diskhaler, and Respimat] without receiving verbal or demonstrative instruction with allowable access to the patient information leaflets in native language supported by figures with enough time to read (baseline assessment']","['Diskhaler, pMDI, and Respimat']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],180.0,0.0477912,The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05).,"[{'ForeName': 'Hadeer S', 'Initials': 'HS', 'LastName': 'Harb', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Nabila Ibrahim', 'Initials': 'NI', 'LastName': 'Laz', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Rabea', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed E A', 'Initials': 'MEA', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}]",Experimental lung research,['10.1080/01902148.2020.1789903']
2115,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE


This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy.
MATERIALS AND METHODS


This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment.
RESULTS


All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response.
CONCLUSIONS


Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609']
2116,32615487,A quasi-cluster randomized controlled trial of a classroom-based mental health literacy educational intervention to promote knowledge and help-seeking/helping behavior in adolescents.,"INTRODUCTION


School-based education is a potentially effective approach for improving mental health literacy (MHL) in adolescents. This study evaluated the effects of the ""Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL in adolescents in a quasi-cluster randomized controlled trial.
METHODS


A total of 975 high school first graders (age 15-16) in Japan were allocated to classes such that gender and academic achievement ratios were almost equivalent at the time of admission to the high school. They were assigned at the class level to the SMHLP (n = 364 from 10 classes) or a control group (n = 611 from 17 classes). The program consisted of a 50-minute session and was delivered by a school teacher. The students completed a self-report questionnaire at 3 time points: pre-, (immediately) post- and 2-month follow-up. Outcomes included ""Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers"". Mixed effects modeling was employed for analyses.
RESULTS


Scores of all outcomes were significantly improved in the intervention group compared to the control group post-intervention (p < .001). These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05). Questionnaire scores did not differ between groups at baseline.
CONCLUSIONS


The effect of the SMHLP was confirmed in grade 10 students. Brief, yet effective programs can be a viable option to promote understanding of mental health problems and have the potential to be incorporated into regular school curriculum. "".",2020,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"['A total of 975 high school first graders (age 15-16) in Japan', 'grade 10 students', 'adolescents']","['SMHLP', 'classroom-based mental health literacy educational intervention', 'Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL']","['Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers', 'Questionnaire scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0024851', 'cui_str': 'Marshall Islands'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023865', 'cui_str': 'Literacy Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",975.0,0.047281,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: yama-s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8553, Japan. Electronic address: ojio@ncnp.go.jp.'}, {'ForeName': 'Jerome Clifford', 'Initials': 'JC', 'LastName': 'Foo', 'Affiliation': 'Central Institute of Mental Health, Department of Genetic Epidemiology in Psychiatry, Medical Faculty Mannheim, University of Heidelberg, J5 68159, Mannheim, Germany. Electronic address: jeromefoo@gmail.com.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Michigami', 'Affiliation': 'Saitama Prefectural Soka Higashi High School, 1110-1 Kakinoki-cho, Soka, Saitama, 340-0001, Japan. Electronic address: michigami@msj.biglobe.ne.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Usami', 'Affiliation': 'Center for Research and Development on Transition from Secondary to Higher Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: usami_s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Taruto', 'Initials': 'T', 'LastName': 'Fuyama', 'Affiliation': 'Graduate School of Film and New Media, Tokyo University of the Arts, 4-23, Kaigan-dori, Naka-ku, Yokohama, Kanagawa, 231-0002, Japan. Electronic address: fuyan@taruto.com.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Onuma', 'Affiliation': 'Department of Health and Nutrition, Laboratory of Practical Yogo Science, Kagawa Education Institute of Nutrition, 3-9-21 Chiyoda, Sakado, Saitama, 350-0288, Japan. Electronic address: kokumichan@gmail.com.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Oshima', 'Affiliation': 'Office for Mental Health Support, Division for Counseling and Support, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: rxg01737@qg8.so-net.ne.jp.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Tokyo Metropolitan Institute of Medical Science, 2-1-6, Kamikitazawa, Setagaya-ku, Tokyo, 156-8506, Japan. Electronic address: sandou-tky@umin.ac.jp.'}, {'ForeName': 'Fumiharu', 'Initials': 'F', 'LastName': 'Togo', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: tougou@p.u-tokyo.ac.jp.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: psytokyo577@gmail.com.'}]",Journal of adolescence,['10.1016/j.adolescence.2020.05.002']
2117,32615488,Effects of the juçara fruit supplementation on metabolic parameters in individuals with obesity: a double-blind randomized controlled trial.,"Adipose tissue inflammation has been proposed as a central mechanism connecting obesity with its metabolic and vascular complications due to the imbalance in the expression of several hormones and adipokines. Berries rich in polyphenols and unsaturated fatty acids have been able to prevent both obesity and adipose tissue inflammation, improving metabolic functions in human subjects and animal models of obesity. Juçara has been considered a super fruit owing to its nutritional composition and relevant biological activities with an interesting response in animals. Thus, we aimed to verify the potential antiobesogenic effect of juçara supplementation in humans. We conducted a double-blind, placebo-controlled, randomized trial with 35 adults with obesity of both sexes. They were assessed for resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines. Subsequently, they were randomized into two groups to use or not (placebo) 5 g lyophilized juçara for 6 weeks. Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin. Besides, juçara supplementation, high-density lipoprotein cholesterol and neck circumference were predictors to explain the enhancement in adiponectin. Juçara supplementation was determinant to improve adiponectin levels, and it may be considered a novel strategy for the treatment of obesity-related metabolic diseases.",2020,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","['35 adults with obesity of both sexes', 'individuals with obesity', 'humans']","['juçara fruit supplementation', 'juçara supplementation', 'not (placebo', 'placebo']","['body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin', 'resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines', 'juçara supplementation, high-density lipoprotein cholesterol and neck circumference', 'metabolic parameters', 'adiponectin levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",35.0,0.113597,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","[{'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Jamar', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Aline Boveto', 'Initials': 'AB', 'LastName': 'Santamarina', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Flygare', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Gagliardi', 'Affiliation': 'Departamento de Medicina Cardiovascular, Angiocorpore Instituto de Medicina Cardiovascular, Santos, SP, Brazil.'}, {'ForeName': 'Veridiana Vera', 'Initials': 'VV', 'LastName': 'de Rosso', 'Affiliation': 'Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Luciana Pellegrini', 'Initials': 'LP', 'LastName': 'Pisani', 'Affiliation': 'Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil; Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil. Electronic address: lucianapisani@gmail.com.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108430']
2118,32619524,Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.,"BACKGROUND


Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
OBJECTIVES


The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes.
METHODS


In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076']
2119,32641012,Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol.,"BACKGROUND


Restoring community walking remains a highly valued goal for persons recovering from traumatic incomplete spinal cord injury (SCI). Recently, studies report that brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy in persons with chronic (> 1 year) SCI. More persistent walking recovery may occur following repetitive (weeks) AIH treatment involving persons with more acute SCI, but this possibility remains unknown. Here we present our clinical trial protocol, designed to examine the distinct influences of repetitive AIH, with and without walking practice, on walking recovery in persons with sub-acute SCI (< 12 months) SCI. Our overarching hypothesis is that daily exposure (10 sessions, 2 weeks) to AIH will enhance walking recovery in ambulatory and non-ambulatory persons with subacute (< 12 months) SCI, presumably by harnessing endogenous mechanisms of plasticity that occur soon after injury.
METHODS


To test our hypothesis, we are conducting a randomized, placebo-controlled clinical trial on 85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group). The non-ambulatory group receives either daily AIH (15, 90s episodes at 10.0% O 2  with 60s intervals at 20.9% O 2 ) or daily SHAM (15, 90s episodes at 20.9% O 2  with 60s intervals at 20.9% O 2 ) intervention. The ambulatory group receives either 60-min walking practice (WALK), daily AIH + WALK, or daily SHAM+WALK intervention. Our primary outcome measures assess overground walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up & Go Test). For safety, we also measure levels of pain, spasticity, systemic hypertension, and autonomic dysreflexia. We record outcome measures at baseline, days 5 and 10, and follow-ups at 1 week, 1 month, 6 months, and 12 months post-treatment.
DISCUSSION


The goal of this clinical trial is to reveal the extent to which daily AIH, alone or in combination with task-specific walking practice, safely promotes persistent recovery of walking in persons with traumatic, subacute SCI. Outcomes from this study may provide new insight into ways to enhance walking recovery in persons with SCI.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02632422 . Registered 16 December 2015.",2020,More persistent walking recovery may occur following repetitive (weeks),"['85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group', 'persons with SCI', 'persons with subacute spinal cord injury', 'persons with more acute SCI', 'persons with chronic (>\u20091\u2009year) SCI', 'persons with traumatic, subacute SCI', 'persons with sub-acute SCI (<\u200912\u2009months) SCI', 'persons recovering from traumatic incomplete spinal cord injury (SCI']","['Daily acute intermittent hypoxia', 'SHAM', '60-min walking practice (WALK), daily AIH\u2009+\u2009WALK, or daily SHAM+WALK intervention', 'placebo']","['walking function', 'overground walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up & Go Test', 'pain, spasticity, systemic hypertension, and autonomic dysreflexia']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021589', 'cui_str': 'Artificial insemination, homologous'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0238015', 'cui_str': 'Autonomic dysreflexia'}]",85.0,0.134924,More persistent walking recovery may occur following repetitive (weeks),"[{'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Naidu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Peters', 'Affiliation': 'Department of Rehabilitation & Movement Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Andrew Q', 'Initials': 'AQ', 'LastName': 'Tan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Barth', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Crane', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Link', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Balakrishnan', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Hayes', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Slocum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Zafonte', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Trumbower', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA. randy.trumbower@mgh.harvard.edu.'}]",BMC neurology,['10.1186/s12883-020-01851-9']
2120,32641023,Design of the PROstate cancer follow-up care in Secondary and Primary hEalth Care study (PROSPEC): a randomized controlled trial to evaluate the effectiveness of primary care-based follow-up of localized prostate cancer survivors.,"BACKGROUND


In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative.
METHODS


This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment.
DISCUSSION


This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors.
TRIAL REGISTRATION


Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.",2020,"This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness.","['patients who have completed primary treatment for localized prostate cancer', 'Prospectively registered on 11 June 2018', 'localized prostate cancer survivors', 'Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N\u2009=\u2009195) or', 'localized prostate cancer']","['general practitioner-based (N\u2009=\u2009195) follow-up care', 'specialist-based follow-up care compared to general practitioner-based follow-up care', 'specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517624', 'cui_str': '195'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.114065,"This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness.","[{'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Wollersheim', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Kristel M', 'Initials': 'KM', 'LastName': 'van Asselt', 'Affiliation': 'Department of General Practice, Amsterdam UMC location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'van der Poel', 'Affiliation': 'Department of Urology, Antoni van Leeuwenhoek Hospital, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk C P M', 'Initials': 'HCPM', 'LastName': 'van Weert', 'Affiliation': 'Department of General Practice, Amsterdam UMC location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hauptmann', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Valesca P', 'Initials': 'VP', 'LastName': 'Retèl', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Aaronson', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Lonneke V', 'Initials': 'LV', 'LastName': 'van de Poll-Franse', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Annelies H', 'Initials': 'AH', 'LastName': 'Boekhout', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands. a.boekhout@nki.nl.'}]",BMC cancer,['10.1186/s12885-020-07112-9']
2121,32641142,Efficacy and safety of the extracorporeal shockwave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial.,"BACKGROUND


Postherpetic neuralgia (PHN) is one of the most common types of chronic neuropathic pain, which seriously affects quality of the life because of pain severity and poor response to the currently available treatments. The main strategies for PHN management are medication and invasive interventional therapies; however, these approaches have many adverse effects, so it is important to find another effective and safe treatment for PHN.
METHODS


A single-center, single-blind randomized clinical trial will evaluate 98 study participants randomized in a 1:1 ratio into control and experimental groups. The control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will receive extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12. The plasma levels of tumor necrosis factor-α and interleukin-6 will be assessed before and after ESWT to explore the biochemical mechanisms of ESWT in the treatment of PHN.
DISCUSSION


This randomized controlled trial will evaluate the effectiveness and safety of ESWT in patients with PHN and thus will provide clinical evidence for its use in the management of PHN and explore the potential biochemical mechanisms of this treatment.
TRIAL REGISTRATION


www.ChiCTR.org.cn , identifier: ChiCTR1900025828. Registered on 10 September 2019.",2020,"Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12.","['patients with postherpetic neuralgia', 'patients with PHN']","['ESWT', 'extracorporeal shockwave therapy (ESWT', 'conventional treatment including medication therapy and invasive interventional therapy', 'extracorporeal shockwave therapy']","['pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI', 'Efficacy and safety', 'plasma levels of tumor necrosis factor-α and interleukin-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",98.0,0.0776759,"Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ruihao', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Fuguo', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China. zerodq_hx@163.com.""}, {'ForeName': 'Pingliang', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chengdu Medical College, Xindu, 610500, Sichuan, People's Republic of China. pingliangyang@163.com.""}]",Trials,['10.1186/s13063-020-04564-z']
2122,32641154,Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).
TRIAL DESIGN


Randomised, parallel 3-arm (1:1:1 ratio), open-label, Phase IV platform trial of immunomodulatory therapies in patients with late stage 1 or stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and/or radiological assessment.
PARTICIPANTS


Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a Risk count (as defined below) >3 OR ≥3 if risk count includes ""Radiographic severity score >3"". A risk count is calculated by the following features on admission (1 point for each): radiographic severity score >3, male gender, non-white ethnicity, diabetes, hypertension, neutrophils >8.0 x10 9 /L, age >40 years and CRP >40 mg/L. Patients should be considered an appropriate subject for intervention with immunomodulatory therapies in the opinion of the investigator and be able to be maintained on venous thromboembolism prophylaxis during the inpatient dosing period, according to local guidelines. The complete inclusion and exclusion criteria as detailed in the additional file 1 should be fulfilled. Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support. Participants will be recruited across multiple centres including initially at Cambridge University Hospitals NHS Foundation Trust, King's College Hospital NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, University Hospital of Wales, Gloucestershire Royal Hospitals NHS Foundation Trust and The Royal Wolverhampton NHS Trust.
INTERVENTION AND COMPARATOR


Each active comparator arm will be compared against standard of care (SoC). The immunomodulatory drugs were selected from a panel of licenced candidates by a drug evaluation committee, which considered potential efficacy, potential toxicity, scalability and novelty of each strategy. The initial active arms comprise baricitinib and ravulizumab. Baricitinib will be given 4 mg orally (once daily (OD)) on days 1-14 or until day of discharge. The dose will be reduced to 2 mg OD for patients aged > 75 years and those with an estimated Cockcroft Gault creatinine clearance of 30-60 ml/min. Ravulizumab will be administered intravenously once according to the licensed weight-based dosing regimen (see Additional file 1). Each active arm will be compared with standard of care alone. No comparisons will be made between active arms in this platform trial.
MAIN OUTCOMES


The primary outcome is the incidence (from baseline up to Day 14) of any one of the events (whichever comes first): death, invasive mechanical ventilation, extra corporeal membrane oxygenation, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min).
RANDOMISATION


Eligible patients will be randomised using a central web-based randomisation service (Sealed Envelope) in a 1:1:1 ratio, stratified by site to one of the treatment arms or SoC.
BLINDING (MASKING)


This is an open-label trial. Data analysis will not be blinded.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


There is no fixed sample size for this study. Serial interim analyses will be triggered by an Independent Data Monitoring Committee (IDMC), including analysis after 125 patients are recruited to each arm, 375 in total assuming 3 arms. Additional interim analyses are projected after 229 patients per arm, and potentially then after 469 per arm, but additional analyses may be triggered by the IDMC.
TRIAL STATUS


TACTIC-R Protocol version number 2.0 date May 20, 2020, recruitment began May 7, 2020 and the end trial will be the date 18 months after the last patient's last visit. The recruitment end date cannot yet be accurately predicted.
TRIAL REGISTRATION


Registered on EU Clinical Trials Register EudraCT Number: 2020-001354-22 Registered: 6 May 2020 It was registered on ClinicalTrials.gov ( NCT04390464 ) and on ISRCTN (ISRCTN11188345) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).
","['Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a Risk count (as defined below) ', '125 patients are recruited to each arm, 375 in total assuming 3 arms', 'Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R', 'patients with late stage 1 or stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and/or radiological assessment', 'Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support', ""Participants will be recruited across multiple centres including initially at Cambridge University Hospitals NHS Foundation Trust, King's College Hospital NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, University Hospital of Wales, Gloucestershire Royal Hospitals NHS Foundation Trust and The Royal Wolverhampton NHS Trust"", 'patients aged > 75 years and those with an estimated Cockcroft Gault creatinine clearance of 30-60 ml/min']","['specific immunomodulatory intervention', 'Ravulizumab']","['Radiographic severity score', 'incidence (from baseline up to Day 14) of any one of the events (whichever comes first): death, invasive mechanical ventilation, extra corporeal membrane oxygenation, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018408', 'cui_str': 'Guyana'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0454854', 'cui_str': 'Gloucestershire'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.473607,"To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).
","[{'ForeName': 'Spoorthy', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK. Spoorthy.kulkarni@addenbrookes.nhs.uk.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fisk', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Kostapanos', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Banham-Hall', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Hernan-Sancho', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': ""King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cope', 'Affiliation': ""King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Galloway', 'Affiliation': ""King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hall', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, The Old Schools, Trinity Lane, Cambridge, CB2 1TN, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'University of Cambridge, The Old Schools, Trinity Lane, Cambridge, CB2 1TN, UK.'}]",Trials,['10.1186/s13063-020-04535-4']
2123,32641163,Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)-protocol of randomised controlled trial AZIQUINE-ICU.,"BACKGROUND


Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin. We hypothesise that early administration of hydroxychloroquine alone or in combination with azithromycin can prevent respiratory deterioration in patients admitted to intensive care due to rapidly progressive COVID-19 infection.
METHODS


Design: Prospective, multi-centre, double-blind, randomised, controlled trial (RCT).
PARTICIPANTS


Adult (> 18 years) within 24 h of admission to the intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria include duration symptoms of febrile disease for ≥ 1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, and pregnancy.
INTERVENTIONS


Patients will be randomised in 1:1:1 ratio to receive Hydroxychloroquine 800 mg orally in two doses followed by 400 mg daily in two doses and azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or hydroxychloroquine + placebo (HC group) or placebo + placebo (C-group) in addition to the best standard of care, which may evolve during the trial period but will not differ between groups. Primary outcome is the composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.
SECONDARY OUTCOMES


The percentage of patients who were prevented from needing intubation until day 14, ICU length of stay, and mortality (in hospital) at day 28 and 90.
DISCUSSION


Although both investigational drugs are often administered off label to patients with severe COVID-19, at present, there is no data from RCTs on their safety and efficacy. In vitro and observational trial suggests their potential to limit viral replication and the damage to lungs as the most common reason for ICU admission. Therefore, patients most likely to benefit from the treatment are those with severe but early disease. This trial is designed and powered to investigate whether the treatment in this cohort of patients leads to improved clinical patient-centred outcomes, such as mechanical ventilation-free survival.
TRIAL REGISTRATION


Clinical trials.gov: NCT04339816 (Registered on 9 April 2020, amended on 22 June 2020); Eudra CT number: 2020-001456-18 (Registered on 29 March 2020).",2020,"BACKGROUND


Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin.","['in hospital) at day 28 and 90', 'patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)-protocol', 'Eudra CT number: 2020-001456-18', 'Design', 'patients admitted to intensive care due to rapidly progressive COVID-19 infection', 'Adult (>\u200918\u2009years) within 24\u2009h of admission to the intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated', '9 April 2020, amended on 22 June 2020']","['Hydroxychloroquine 800\u2009mg orally in two doses followed by 400\u2009mg daily in two doses and azithromycin 500\u2009mg orally in one dose followed by 250\u2009mg in one dose for a total of 5\u2009days (HC-A group) or hydroxychloroquine + placebo (HC group) or placebo + placebo (C-group', 'azithromycin', 'Azithromycin', 'hydroxychloroquine']","['respiratory deterioration', 'needing intubation until day 14, ICU length of stay, and mortality', 'composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1126333', 'cui_str': 'Azithromycin 500 MG'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",,0.370962,"BACKGROUND


Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin.","[{'ForeName': 'František', 'Initials': 'F', 'LastName': 'Duška', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic. frantisek.duska@lf3.cuni.cz.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Waldauf', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Halačová', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Václav', 'Initials': 'V', 'LastName': 'Zvoníček', 'Affiliation': 'Masaryk University, Medical Faculty and U Svate Anny University Hospital, Brno, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Bala', 'Affiliation': 'Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Balík', 'Affiliation': 'Charles University, 1st Faculty of Medicine and VFN University Hospital Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beneš', 'Affiliation': 'Charles University, Medical Faculty and University Hospital Plzen, Pilsen, Czech Republic.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Klementová', 'Affiliation': 'Medical Faculty, Palacky University and Olomouc University Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Kozáková', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kubricht', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Le Roy', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Vymazal', 'Affiliation': 'Charles University, 2nd Faculty of Medicine, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Řehořová', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Černý', 'Affiliation': ""Czech Anaesthesia Clinical Trials and Audit Network and Department of Anaesthesia and Intensive Care, Masaryk's Hospital, Ústí nad Labem, Czech Republic.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04566-x']
2124,32641338,"'Only twice a year': a qualitative exploration of 6-month antiretroviral treatment refills in adherence clubs for people living with HIV in Khayelitsha, South Africa.","OBJECTIVE


Longer intervals between routine clinic visits and medication refills are part of patient-centred, differentiated service delivery (DSD). They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART). This qualitative study explored patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6 months in adherence clubs in Khayelitsha, South Africa.
DESIGN AND SETTING


In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants. All transcripts were audio-recorded, transcribed and translated to English, manually coded and thematically analysed. The participants had been involved in a randomised controlled trial evaluating multi-month ART dispensing in adherence clubs, comparing 6-month and 2-month refills.
PARTICIPANTS


Twenty-three patients, seven healthcare workers and six key informants.
RESULTS


Patients found that 6-month refills increased convenience and reduced unintended disclosure. Contrary to key informant concerns about patients' responsibility to manage larger quantities of ART, patients receiving 6-month refills were highly motivated and did not face challenges transporting, storing or adhering to treatment. All participant groups suggested that strict eligibility criteria were necessary for patients to realise the benefits of extended dispensing intervals. Six-month refills were felt to increase health system efficiency, but there were concerns about whether the existing drug supply system could adapt to 6-month refills on a larger scale.
CONCLUSIONS


Patients, healthcare workers and key informants found 6-month refills within adherence clubs acceptable and beneficial, but concerns were raised about the reliability of the supply chain to manage extended multi-month dispensing. Stepwise, slow expansion could avoid overstressing supply and allow time for the health system to adapt, permitting 6-month ART refills to enhance current DSD options to be more efficient and patient-centred within current health system constraints.",2020,They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART).,"['Twenty-three patients, seven healthcare workers and six key informants', 'people living with HIV in Khayelitsha, South Africa', 'patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6\u2009months in adherence clubs in Khayelitsha, South Africa', 'In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants']",[],"['unintended disclosure', 'health system efficiency']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",[],"[{'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",23.0,0.048509,They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART).,"[{'ForeName': 'Claire Marriott', 'Initials': 'CM', 'LastName': 'Keene', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa clairekeene@gmail.com.'}, {'ForeName': 'Nompumelelo', 'Initials': 'N', 'LastName': 'Zokufa', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Emilie C', 'Initials': 'EC', 'LastName': 'Venables', 'Affiliation': 'Southern Africa Medical Unit, Medecins Sans Frontieres South Africa, Cape Town, South Africa.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Wilkinson', 'Affiliation': 'International AIDS Society, Cape Town, South Africa.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Disease, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cassidy', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Snyman', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Grimsrud', 'Affiliation': 'International AIDS Society, Cape Town, South Africa.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Voget', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'von der Heyden', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Siphokazi', 'Initials': 'S', 'LastName': 'Zide-Ndzungu', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Vinayak', 'Initials': 'V', 'LastName': 'Bhardwaj', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Isaakidis', 'Affiliation': 'Southern Africa Medical Unit, Medecins Sans Frontieres South Africa, Cape Town, South Africa.'}]",BMJ open,['10.1136/bmjopen-2020-037545']
2125,32641337,FitSkills: protocol for a stepped wedge cluster randomised trial of a community-based exercise programme to increase participation among young people with disability.,"INTRODUCTION


There is a need to develop relevant, acceptable initiatives that facilitate physical activity participation in young people with disability.  FitSkills  was developed to support young people with disability to exercise. The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability. The secondary aims are to evaluate cost-effectiveness, changes in attitudes towards disability and other health-related outcomes for young people with disability.
METHODS AND ANALYSIS


A stepped wedge cluster randomised trial using a cohort design and embedded health economic evaluation will compare the effect of  FitSkills  with a control phase.  FitSkills  matches a young person with disability with a student mentor and the pair exercise together at their local gymnasium for 1 hour, two times per week for 12 weeks (24 sessions in total). One hundred and sixty young people with disability aged 13 to 30 years will be recruited. Eight community gymnasia will be recruited and randomised into four cluster units to have  FitSkills  introduced at 3-month intervals. Primary (feasibility, participation and health-related quality of life) and secondary outcomes will be collected longitudinally every 3 months from trial commencement, with eight data collection time points in total. The Practical Robust Implementation and Sustainability Model will be used to support knowledge translation and implementation of project findings into policy and practice.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the La Trobe University Human Ethics Committee (HEC17-012), Australian Catholic University (2017-63R), Deakin University (2017-206) and the Victorian Department of Education and Training (2018_003616). Results will be disseminated through published manuscripts, conference presentations, public seminars and practical resources for stakeholder groups.
TRIAL REGISTRATION NUMBER


ACTRN12617000766314.
TRIAL SPONSOR


La Trobe University.",2020,"The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability.","['Eight community gymnasia', 'One hundred and sixty young people with disability aged 13 to 30 years', 'young people with disability']",['community-based exercise programme'],"['Primary (feasibility, participation and health-related quality of life']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",160.0,0.131616,"The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability.","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia n.shields@latrobe.edu.au.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Willis', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Imms', 'Affiliation': 'Centre for Disability and Development Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Prendergast', 'Affiliation': 'Department of Mathematics and Statistics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Watts', 'Affiliation': 'School of Health and Social Development, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van Dorsselaer', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'McKenzie', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Bruder', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037153']
2126,32641340,Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial.,"INTRODUCTION


Sepsis is defined as detrimental immune response to an infection. This overwhelming reaction often abolishes a normal reconstitution of the immune cell homeostasis that in turn increases the risk for further complications. Recent studies revealed a favourable impact of ketone bodies on resolution of inflammation. Thus, a ketogenic diet may provide an easy-to-apply and cost-effective treatment option potentially alleviating sepsis-evoked harm. This study is designed to assess the feasibility, efficiency and safety of a ketogenic diet in septic patients.
METHODS AND ANALYSIS


This monocentric study is a randomised, controlled and open-label trial, which is conducted on an intensive care unit of a German university hospital. As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied. The primary endpoint is the detection of ketone bodies in patients' blood and urine samples. As secondary endpoints, the impact on important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality) and the effect on the immune system are analysed.
ETHICS AND DISSEMINATION


The study has received the following approvals: Ethics Committee of the Medical Faculty of Ruhr-University Bochum (No. 18-6557-BR). Results will be made available to critical care survivors, their caregivers, the funders, the critical care societies and other researchers by publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS


German Clinical Trial Register (DRKS00017710); Universal Trial Number (U1111-1237-2493).",2020,As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied.,"['septic patients', 'intensive care unit of a German university hospital', 'septic patients on ICU']","['intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control', 'carbohydrate-reduced nutrition', 'ketogenic diet']","['important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality', 'feasibility, efficiency and safety', ""detection of ketone bodies in patients' blood and urine samples""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",,0.164771,As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rahmel', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany tim.rahmel@ruhr-uni-bochum.de.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Hübner', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Koos', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Katrin-Maria', 'Initials': 'KM', 'LastName': 'Willemsen', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Strauß', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Effinger', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Adamzik', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kreth', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-038532']
2127,32641343,Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


The rapid worldwide spread of COVID-19 has caused a global health crisis. To date, symptomatic supportive care has been the most common treatment. It has been reported that the mechanism of COVID-19 is related to cytokine storms and subsequent immunogenic damage, especially damage to the endothelium and alveolar membrane. Vitamin C (VC), also known as L-ascorbic acid, has been shown to have antimicrobial and immunomodulatory properties. A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS). Therefore, we hypothesise that HIVC could be added to the treatment of ARDS and multiorgan dysfunction related to COVID-19.
METHODS AND ANALYSIS


The investigators designed a multicentre prospective randomised placebo-controlled trial that is planned to recruit 308 adults diagnosed with COVID-19 and transferred into the intensive care unit. Participants will randomly receive HIVC diluted in sterile water or placebo for 7 days once enrolled. Patients with a history of VC allergy, end-stage pulmonary disease, advanced malignancy or glucose-6-phosphate dehydrogenase deficiency will be excluded. The primary outcome is ventilation-free days within 28 observational days. This is one of the first clinical trials applying HIVC to treat COVID-19, and it will provide credible efficacy and safety data. We predict that HIVC could suppress cytokine storms caused by COVID-19, help improve pulmonary function and reduce the risk of ARDS of COVID-19.
ETHICS AND DISSEMINATION


The study protocol was approved by the Ethics Committee of Zhongnan Hospital of Wuhan University (identifiers: Clinical Ethical Approval No. 2020001). Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
TRIAL REGISTRATION NUMBER


NCT04264533.",2020,"A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS).","['308 adults diagnosed with COVID-19 and transferred into the intensive care unit', 'patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS', 'Patients with a history of VC allergy, end-stage pulmonary disease, advanced malignancy or glucose-6-phosphate dehydrogenase deficiency will be excluded', 'Zhongnan Hospital of Wuhan University (identifiers']","['intravenous VC (HIVC', 'HIVC diluted in sterile water or placebo', 'Intravenous high-dose vitamin C', 'Vitamin C (VC', 'placebo']","['ventilation-free days', 'pulmonary function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",308.0,0.489427,"A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China Pengzy5@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-039519']
2128,32613240,Varying levels of serum estradiol do not alter the timing of the early endometrial secretory transformation.,"STUDY QUESTION


Do supraphysiologic estradiol (E2) levels in the ranges attained during normal and high response superovulation cycles modify the onset of endometrial secretory transformation?
SUMMARY ANSWER


Highly supraphysiologic levels of E2 do not alter the ability of physiologic levels of progesterone (P4) to induce secretory transformation.
WHAT IS KNOWN ALREADY


Previous studies have demonstrated that premature P4 elevations during IVF cycles are associated with a decrement in clinical pregnancy rates after fresh embryo transfer due to shifts in the window of implantation (WOI). However, alterations in the onset of secretory transformation may not apply uniformly to all patients. High responders with supraphysiologic E2 levels accompanied by similar subtle increases in P4 have not been shown to have decreased sustained implantation rates. This prospective investigation in which whole-genome transcriptomic and methylomic analysis of the endometrium is performed for individual patients under a range of E2 concentrations brings clarity to a long-debated issue.
STUDY DESIGN, SIZE, DURATION


A randomized, prospective and paired trial was conducted in which 10 participants were enrolled and randomized to the order in which they completed three distinct uterine stimulation cycles, each at a specific E2 concentration: physiologic (∼180 pg/ml), moderately supraphysiologic (600-800 pg/ml) or supraphysiologic (2000 pg/ml). Target E2 ranges were selected to mimic those seen in natural, controlled ovarian stimulation and IVF cycles. E2 valerate was administered in order to maintain stable E2 levels for 12 days followed by intramuscular P4 in oil 10 mg/day for two doses, after which an endometrial biopsy was performed. A total of 30 endometrial biopsies were included in a whole-genome transcriptomic and methylomic analysis.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Healthy volunteers without a history of infertility were included in this study at a single large infertility center. DNA was isolated from the endometrial biopsy specimens and bisulfite sequencing was performed to construct a methylation array. Differential methylation analysis was conducted based on differences in M-values of individuals across treatment groups for each probe as well as carrying out t-tests. RNA was isolated for RNA-Seq analysis and gene expression values were compared using DESeq2. All analyses were performed in a pairwise fashion to compare among the three stimulation cycles within individuals and secondarily to compare all participants in each of the cycles.
MAIN RESULTS AND THE ROLE OF CHANCE


The mean peak E2 and P4 levels were 275 pg/ml and 4.17 ng/ml in the physiologic group, 910 pg/ml and 2.69 ng/ml in the moderate group was, and 2043 pg/ml and 2.64 ng/ml in the supraphysiologic group, respectively. Principal component analysis of 834 913 CpG sites was performed on M-values of individuals within the low, moderate and supraphysiologic conditions in a paired approach. There were no differences in genome-wide methylation within participants across E2 groups. A paired analysis revealed that gene expression profiles did not differ within the same individual at each of the three E2 levels. No significant alterations in gene expression as related to endometrial physiology were identified between the low, moderate and supraphysiologic groups in an inter-participant analysis.
LIMITATIONS, REASONS FOR CAUTION


Although each participant completed a physiologic cycle in which E2 levels were maintained in a range that would simulate a natural cycle, our findings are limited by lack of an unmedicated control to assess if there was a potential effect from E2V. Additionally, our results were obtained in fertile individuals, who may have a different endometrial response compared to an infertile population. Despite the whole genomic endometrial assessment and rigorous, paired study design, the sample size was limited.
WIDER IMPLICATIONS OF THE FINDINGS


Given that the endometrial response to P4 is unaffected by E2 levels in the supraphysiologic range, diminutions in implantation seen in stimulated cycles may result from embryonic-endometrial dyssynchrony following early P4 elevations or slowly blastulating embryos, which occur independently of the magnitude of the E2 rise.
STUDY FUNDING/COMPETING INTEREST(S)


This study was funded by the Foundation for Embryonic Competence, Basking Ridge, NJ, USA. Dr E.S. reports consultancy work for The Foundation for Embryonic Competence, Basking Ridge, NJ, USA. The other authors declare no conflict of interests related to this topic.
TRIAL REGISTRATION NUMBER


NCT02458404.",2020,"No significant alterations in gene expression as related to endometrial physiology were identified between the low, moderate and supraphysiologic groups in an inter-participant analysis.
","['Healthy volunteers without a history of infertility were included in this study at a single large infertility center', '10 participants', 'A total of 30 endometrial biopsies were included in a whole-genome transcriptomic and methylomic analysis']","['specific E2 concentration: physiologic (∼180 pg/ml), moderately supraphysiologic (600-800 pg/ml) or supraphysiologic', 'E2 valerate']","['gene expression profiles', 'genome-wide methylation', 'endometrial physiology', 'Varying levels of serum estradiol', 'mean peak E2 and P4 levels', 'clinical pregnancy rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0042280', 'cui_str': 'Pentanoates'}]","[{'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",10.0,0.203383,"No significant alterations in gene expression as related to endometrial physiology were identified between the low, moderate and supraphysiologic groups in an inter-participant analysis.
","[{'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Osman', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'The Foundation for Embryonic Competence, Basking Ridge, NJ, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'The Foundation for Embryonic Competence, Basking Ridge, NJ, USA.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Juneau', 'Affiliation': 'Audubon Fertility, New Orleans, LA, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Morin', 'Affiliation': 'IVI-RMA Northern California, San Francisco, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Seli', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Scott', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Franasiak', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa135']
2129,32615110,"Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy for newly diagnosed ovarian cancer (ICON8): quality-of-life results of a phase 3, randomised, controlled trial.","BACKGROUND


The ICON8 study reported no significant improvement in progression-free survival (a primary endpoint) with weekly chemotherapy compared with standard 3-weekly treatment among patients with epithelial ovarian cancer. All ICON8 patients were eligible to take part in the accompanying health-related quality-of-life study, which measured the effect of treatment on self-reported wellbeing, reported here.
METHODS


In this open-label, randomised, controlled, phase 3, three-arm, Gynecologic Cancer Intergroup (GCIG) trial done at 117 hospital sites in the UK, Australia, New Zealand, Mexico, South Korea, and Republic of Ireland, women (aged at least 18 years) with newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics stage IC-IV ovarian cancer and an Eastern Cooperative Oncology Group performance status of 0-2 were randomly assigned (1:1:1) centrally using minimisation to group 1 (intravenous carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2  intravenous paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2  paclitaxel weekly), or group 3 (carboplatin AUC2 weekly and 80 mg/m 2  paclitaxel weekly). Randomisation was stratified by GCIG group, disease stage, and outcome and timing of surgery. Patients and clinicians were not masked to treatment assignment. Patients underwent immediate or delayed primary surgery according to clinicians' choice. Patients were asked to complete European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 questionnaires at enrolment, before each chemotherapy cycle, then 6-weekly up to 9 months, 3-monthly up to 2 years, and 6-monthly up to 5 years. Quality of life was a prespecified secondary outcome of the ICON8 study. Within the quality-of-life study, the co-primary endpoints were QLQ-C30 global health score at 9 months (cross-sectional analysis) and mean QLQ-C30 global health score from randomisation to 9 months (longitudinal analysis). Data analyses were done on an intention-to-treat basis. The trial is registered on ClinicalTrials.gov, NCT01654146 and ISRCTN Registry, ISRCTN10356387, and is currently in long-term follow up.
FINDINGS


Between June 6, 2011, and Nov 28, 2014, 1566 patients were recruited into ICON8 (522 were included in group 1, 523 in group 2, and 521 in group 3). Baseline quality-of-life questionnaires were completed by 1438 (92%) of 1566 patients and 9-month questionnaires by 882 (69%) of 1280 patients. We observed no significant difference in global health score at 9 months (cross-sectional analysis) between study groups (group 2 vs group 1, difference in mean score 2·3, 95% CI -0·4 to 4·9, p=0·095; group 3 vs group 1, -0·8, -3·8 to 2·2, p=0·61). Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018).
INTERPRETATION


We found no evidence of a difference in global quality of life between treatment groups at 9 months; however, patients receiving weekly treatment reported lower mean quality of life across the 9-month period after randomisation. Taken together with the lack of progression-free survival benefit, these findings do not support routine use of weekly paclitaxel-containing regimens in the management of newly diagnosed ovarian cancer.
FUNDING


Cancer Research UK, Medical Research Council, Health Research Board Ireland, Irish Cancer Society, and Cancer Australia.",2020,"Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018).
","['1566 patients and 9-month questionnaires by 882 (69%) of 1280 patients', 'newly diagnosed ovarian cancer (ICON8', 'newly diagnosed ovarian cancer', ""Patients underwent immediate or delayed primary surgery according to clinicians' choice"", 'patients with epithelial ovarian cancer', '117 hospital sites in the UK, Australia, New Zealand, Mexico, South Korea, and Republic of Ireland, women (aged at least 18 years) with newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics stage IC-IV ovarian cancer and an Eastern Cooperative Oncology Group performance status of 0-2', 'Between June 6, 2011, and Nov 28, 2014, 1566 patients were recruited into ICON8 (522 were included in group 1, 523 in group 2, and 521 in group 3']","['Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy', 'paclitaxel', 'minimisation to group 1 (intravenous carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2  intravenous paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2  paclitaxel weekly), or group 3 (carboplatin AUC2 weekly and 80 mg/m 2  paclitaxel', 'paclitaxel-containing regimens', 'chemotherapy']","['global quality of life', 'global health scores', 'mean QLQ-C30 global health score', 'progression-free survival', 'Baseline quality-of-life questionnaires', 'mean quality of life', 'global health score', 'Quality of life', 'Cancer QLQ-C30 and QLQ-OV28 questionnaires', 'QLQ-C30 global health score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",1566.0,0.232117,"Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018).
","[{'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Blagden', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK. Electronic address: sarah.blagden@oncology.ox.ac.uk.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Cook', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Department of Oncology, University Hospital Coventry, Coventry, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Howells', 'Affiliation': 'Maggie Keswick Jencks Cancer Caring Centres Trust, London, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'McNeish', 'Affiliation': 'Ovarian Cancer Action Research Centre, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Oncology Department, St John of God Subiaco Hospital, Perth, WA, Australia.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Dearbhaile M', 'Initials': 'DM', 'LastName': ""O'Donnell"", 'Affiliation': 'Gynaecology Subgroup, Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hook', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'James', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Lord', 'Affiliation': 'Department of Oncology, Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Dark', 'Affiliation': 'Department of Oncology, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Earl', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre, Cambridge, UK.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Centre Institute, University College London, London, UK; University College Hospital, London, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK; University of Manchester, Manchester, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30218-7']
2130,32615895,[Promoting Self-Regulation of Adolescents in School Through Mindfulness].,"Promoting Self-Regulation of Adolescents in School Through Mindfulness. Evaluation of the Mindfulness Training ""8-sam""  Mindfulness describes the psychological process of purposely bringing one's attention to the present experiences with an accepting, non-judgmental attitude. As such, it has attracted increasing interest in educational institutions. The present study aims to evaluate a mindfulness training for adolescents in a German high school. For this purpose, the program ""8-sam"" has been developed. Feasibility, acceptance and efficacy of this four-week training were examined in a sample of 48 ninth-grade students. Self-ratings of mindfulness, chronic stress, emotion regulation and health, as well as behavioral measures of attention and mind-wandering of the intervention group (n = 22) were compared to the wait control group (n = 24) before, immediately and 6 weeks after the training. As indicated by self-designed evaluation questionnaires, the training proved to be well accepted and implementable at school. The intervention group showed less mind-wandering after the training than the control group. The findings offer implications for future research and the application of mindfulness trainings in schools. Implementing mindfulness in the daily school routine promises to support self-regulatory processes and thus, strengthen the resilience of children and adolescents.",2020,The intervention group showed less mind-wandering after the training than the control group.,"['schools', 'children and adolescents', 'sample of 48 ninth-grade students', 'adolescents in a German high school']",['mindfulness training'],"['Self-ratings of mindfulness, chronic stress, emotion regulation and health', 'Feasibility, acceptance and efficacy']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",22.0,0.0106743,The intervention group showed less mind-wandering after the training than the control group.,"[{'ForeName': 'Marie O', 'Initials': 'MO', 'LastName': 'Frenkel', 'Affiliation': 'Institut für Sport und Sportwissenschaft Universität Heidelberg Im Neuenheimer Feld 720 69120 Heidelberg Deutschland Institut für Sport und Sportwissenschaft.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Georg', 'Affiliation': 'Institut für Psychosoziale Prävention Universität Heidelberg Deutschland Institut für Psychosoziale Prävention.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Plessner', 'Affiliation': 'Institut für Sport und Sportwissenschaft Universität Heidelberg Im Neuenheimer Feld 720 69120 Heidelberg Deutschland Institut für Sport und Sportwissenschaft.'}]",Praxis der Kinderpsychologie und Kinderpsychiatrie,['10.13109/prkk.2020.69.4.321']
2131,32616559,Provider visual attention on a respiratory function monitor during neonatal resuscitation.,"BACKGROUND


A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown.
METHODS


Ancillary study to the MONITOR(NCT03256578) randomised controlled trial. Neonatal resuscitation leaders at two centres wore eye-tracking glasses, and visual attention (VA) patterns were compared between RFM-visible and RFM-masked groups.
RESULTS


14 resuscitations (6 RFM-visible, 8 RFM-masked) were analysed. The median total gaze duration on the RFM was significantly higher with a visible RFM (29% vs 1%, p<0.01), while median total gaze duration on other physical objects was significantly lower with a visible RFM (3% vs 8%, p=0.02). Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
CONCLUSION


Providers' VA patterns differed during neonatal resuscitation when the RFM was visible, emphasising the importance of studying the impact of additional delivery room technology on providers' behaviour.",2020,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
",['neonatal resuscitation'],['Provider visual attention'],"['median total gaze duration on other physical objects', 'Median total gaze duration', 'median total gaze duration on the RFM']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",,0.061549,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Herrick', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA herrickh@email.chop.edu.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Weinberg', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cecarelli', 'Affiliation': 'Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Fishman', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Newman', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'den Boer', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Martherus', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Trixie A', 'Initials': 'TA', 'LastName': 'Katz', 'Affiliation': 'Neonatology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Nadkarni', 'Affiliation': ""Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Foglia', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-319291']
2132,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
2133,32619832,Definitive chemoradiotherapy plus cetuximab for cancer in the oesophagus or gastro-oesophageal junction.,"BACKGROUND


Chemoradiotherapy is standard treatment for localized oesophageal cancer unsuitable for surgery. We aimed to evaluate the efficacy of cetuximab in combination with chemoradiotherapy.
METHODS


This non-randomised multicentre phase II trial recruited patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery. Chemotherapy was three 21-day cycles of fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg/m 2, cycle 2-3:85 mg/m 2). Radiotherapy was 50Gy in 2Gy/fraction, 5 days a week, concurrent with cycle 2 and 3 and weekly cetuximab. The primary objective was loco-regional control at one year.
RESULTS


52 patients were included. 51 were eligible for toxicity and survival analysis and 46 for recurrence analysis. Full radiotherapy dose was delivered to 80%, 75% received all three cycles of chemotherapy and 75% received four or more doses of cetuximab. The most common related grade III-IV adverse events were gastro-intestinal(16), hypersensitivity(6) and infection(5). There were two drug-related deaths. Within six months from the end of treatment, six patients died from complications from fistulas. The loco-regional control rate at one year was 47.3%(95%CI 30.9%-62.1%). Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
CONCLUSIONS


Oxaliplatin and fluorouracil given concurrent with radiotherapy and cetuximab had an acceptable safety profile and showed a clinical response in patients with locoregionally advanced oesophageal cancer unsuitable for surgery. However, the primary end-point was not met, and the addition of cetuximab to definitive chemoradiotherapy cannot be recommended.",2020,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","['localized oesophageal cancer unsuitable for surgery', 'cancer in the oesophagus or gastro-oesophageal junction', 'patients with locoregionally advanced oesophageal cancer unsuitable for surgery', 'patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery', '52 patients were included']","['radiotherapy and cetuximab', 'Chemotherapy', 'Definitive chemoradiotherapy plus cetuximab', 'Oxaliplatin and fluorouracil', 'Full radiotherapy', 'cetuximab', 'Chemoradiotherapy', 'fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg', 'Radiotherapy']","['toxicity and survival analysis', 'Overall survival', 'loco-regional control at one year', 'loco-regional control rate']","[{'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",52.0,0.16028,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","[{'ForeName': 'Gabriella Alexandersson', 'Initials': 'GA', 'LastName': 'von Döbeln', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden. Electronic address: gabriella.alexandersson-vondobeln@sll.se.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Wagenius', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Holtved', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anne-Birgitte', 'Initials': 'AB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Oncology, Oslo University hospital, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences Intervention and Technology Karolinska Institutet Division of Upper Abdominal Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baeksgaard', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100187']
2134,32620210,Open-label randomized multi-center phase 2 study: gemcitabine cisplatin plus avelumab or gemcitabine cisplatin as first-line treatment of patients with locally advanced or metastatic urothelial bladder carcinoma: GCisAve.,"BACKGROUND


The standard treatment in first line of advanced or metastatic urothelial bladder cancer (MBC) is the association of Gemcitabine and Cisplatin (GC). Avelumab, an anti-PD-L1 agent, has recently demonstrated efficacy. The objective is to evaluate the combination of these 3 agents.
METHODS


This phase II randomized open-label study, evaluated if GC-avelumab increases response rate and duration of response of patients in 1 st  line treatment for MBC compared to GC. Severe toxicities should not overlap and be acceptable. The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment. The study will recruit 90 participants, randomized in two arms (1:2), GC (gemcitabine 1 000 mg/m 2 /j, J1,J8, Cisplatine 70 mg/m 2 , J1 = J21), and GC-avelumab (10 mg/Kg/3 semaines). Randomization will be stratified on Karnofsky status (≥ 80 % vs. < 80 %) and visceral vs non visceral metastases. The duration of the inclusion period is 24 months, with a duration of participation of each patient of 18 months and a total study duration of 42 months.
DISCUSSION


If both efficacy and safety of the association of GC+avelumab are in the range of acceptable through this specific study design, this will support a subsequent randomized phase III study comparing both arms with an overall survival end-point. In addition, the evaluation of predictive parameters to be confirmed (e.g. the impact of tumor PD-L1 expression) or other immunological parameters, may support a selection of the population. NCT number : NCT03324282.",2020,The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment.,"['patients with locally advanced or metastatic urothelial bladder carcinoma', '90 participants', 'first line of advanced or metastatic urothelial bladder cancer (MBC']","['GC-avelumab', 'Gemcitabine and Cisplatin (GC', 'GC+avelumab', 'GC (gemcitabine', 'gemcitabine cisplatin plus avelumab or gemcitabine cisplatin', 'J1,J8, Cisplatine 70 mg/m 2 , J1 = J21), and GC-avelumab']","['Severe toxicities', 'objective response rate and the incidence of severe toxicity', 'response rate and duration of response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0699885', 'cui_str': 'Carcinoma of bladder'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",90.0,0.0457574,The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment.,"[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France. Electronic address: marine.gross-goupil@chu-bordeaux.fr.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Domblides', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France; Université, Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France EudraCT number: 2017-002087-40.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Lefort', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France; Université, Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France EudraCT number: 2017-002087-40.""}]",Bulletin du cancer,['10.1016/S0007-4551(20)30280-0']
2135,32620212,BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer.,"BACKGROUND


The nivolumab-ipilimumab combination provides an overall response rate of 42% in first-line metastatic treatment of clear cell renal carcinoma (mccRCC). To date, there is no robust predictive biomarker of response to immune checkpoint inhibitor (ICI). In addition, severe autoimmune disorders occur more frequently with ICI combination than with ICI alone. The objective of this study is to compare the efficacy of ICI alone or in combination in patients according to tumor molecular characteristics.
METHODS


Using a 35-gene expression mRNA signature, patients were divided into 4 molecular groups (1 to 4). Patients in groups 1 and 4 were randomized to receive nivolumab alone (arms 1A and 4A) or nivolumab plus ipilimumab for 4 injections followed by nivolumab alone (arms 1B and 4B). Patients in groups 2 and 3 were randomized to receive nivolumab plus ipilimumab followed by nivolumab alone (arms 2B and 3B) or a tyrosine kinase inhibitor (sunitinib or pazopanib at the investigator's choice (arms 2C and 3C)). The main objective is the overall response rate by treatment and molecular group.
DISCUSSION


BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC. This trial is the most appropriate to prospectively identify biomarkers of response to nivolumab used alone or in combination or TKI monotherapy in patients with mccRCC. NCT02960906.",2020,"DISCUSSION


BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC.","['naïve metastatic kidney cancer', '42% in first-line metastatic treatment of clear cell renal carcinoma (mccRCC', 'patients according to tumor molecular characteristics', 'patients with mccRCC', 'Using a 35-gene expression mRNA signature']","['nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI', 'nivolumab alone (arms 1A and 4A) or nivolumab plus ipilimumab', 'nivolumab alone (arms 1B and 4B', 'nivolumab plus ipilimumab followed by nivolumab alone (arms 2B and 3B) or a tyrosine kinase inhibitor (sunitinib or pazopanib', 'nivolumab used alone or in combination or TKI monotherapy', 'ICI']","['overall response rate', 'severe autoimmune disorders']","[{'cui': 'C0862448', 'cui_str': 'Renal cell carcinoma stage IV'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}]",,0.0774426,"DISCUSSION


BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Epaillard', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Simonaggio', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Elaidi', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Fouzia', 'Initials': 'F', 'LastName': 'Azzouz', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Braychenko', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Thibault', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Cheng-Ming', 'Initials': 'CM', 'LastName': 'Sun', 'Affiliation': 'Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moreira', 'Affiliation': 'Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France; INSERM U970. Paris Cardiovascular research Center (PARCC). Université Paris Descartes. Paris. France.'}, {'ForeName': 'Yann-Alexandre', 'Initials': 'YA', 'LastName': 'Vano', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France; Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France. Electronic address: yann.vano@aphp.fr.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30283-6']
2136,32620213,Open-label phase II to evaluate the efficacy of NEoadjuvant dose-dense MVAC In cOmbination with durvalumab and tremelimumab in muscle-invasive urothelial carcinoma: NEMIO.,"BACKGROUND


Neoadjuvant cisplatin-based chemotherapy (NAC) is the standard of care in localized muscle-invasive bladder cancer (MIBC). However, 60-70% of patients have residual tumor after NAC. Based on the overall response rate observed in the metastatic setting, ddMVAC is the most commonly used NAC regimen in Europe. The emergence of immune checkpoint inhibitor (ICI) in the metastatic setting raises the question if the combination of chemo plus ICI could increase the pCR rate.
METHODS/DESIGN


NEMIO is a French open-label randomized phase I/II trial assessing in the neoadjuvant setting the combination of ddMVAC plus durvalumab alone or with tremelimumab: 4 cycles of ddMVAC/2 weeks + 2 cycles of Durvalumab +/- Tremelimumab/4 weeks. Cystectomy is performed 4-8 weeks after the last dose of ddMVAC. Six pts will be included in each arm in a safety run-in cohort to evaluate the toxicity rate. Each arm will be expanded to a maximum of 60 pts. The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE. The primary endpoint of the phase II will be the pathological response rate and G 3/4 TRAE. Exploratory endpoints will include biomarkers of response and resistance to the combo. A total of 120 patients will be included in 15 French centers and we expect the recruitment to be completed in 2021.
DISCUSSION


NEMIO trial will assess for the first time the tolerance and the efficacy of ddMVAC regimen associated with checkpoints inhibitors as neoadjuvant treatment in localized MIBC. NCT number: NCT03549715. Registered on June 8, 2018.",2020,The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE.,"['muscle-invasive urothelial carcinoma', '120 patients will be included in 15 French centers and we expect the recruitment to be completed in 2021']","['durvalumab and tremelimumab', 'ddMVAC/2 weeks + 2 cycles of Durvalumab ', 'ddMVAC', 'Neoadjuvant cisplatin-based chemotherapy (NAC', 'ddMVAC plus durvalumab alone or with tremelimumab', 'NEoadjuvant dose-dense MVAC']","['pathological response rate and G 3/4 TRAE', 'pCR rate', 'safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE', 'overall response rate', 'toxicity rate']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0065452', 'cui_str': 'M-VAC protocol'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",120.0,0.0661061,The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE.,"[{'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Thibault', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris. Electronic address: constance.thibault@aphp.fr.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Elaidi', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Yann-Alexandre', 'Initials': 'YA', 'LastName': 'Vano', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Rouabah', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Braychenko', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Helali', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Audenet', 'Affiliation': 'Department of urology, HEGP, APHP.5 Paris.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30281-2']
2137,32621905,The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).,"Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.",2020,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.",[],"['motivational interviewing-enhanced, integrated behavior therapy', 'video-based behavioral weight loss program and problem-solving therapy']",[],[],"[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]",[],,0.0347898,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Corina R', 'Initials': 'CR', 'LastName': 'Ronneberg', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98104, United States.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Wittels', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Amruta', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Aashutos S', 'Initials': 'AS', 'LastName': 'Patel', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Tessa L', 'Initials': 'TL', 'LastName': 'Eckley', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stetz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Departments of Biobehavioral Health and Medicine, Pennsylvania State University, University Park, PA 16802, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'National Institute of Mental Health (NIMH), National Institutes of Health, Bethesda, MD 20892, United States.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States; Department of Medicine, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States; Department of Medicine, University of Illinois at Chicago, Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106072']
2138,32621918,Dexmedetomidine pretreatment attenuates myocardial ischemia reperfusion induced acute kidney injury and endoplasmic reticulum stress in human and rat.,"BACKGROUND


Patients undergoing cardiopulmonary bypass (CPB) often develop acute kidney injury (AKI) caused by myocardial ischemia reperfusion (MI/R), and this renal injury can be resolved notably by dexmedetomidine. Endoplasmic reticulum (ER) stress was reported to get involved in organ injury including AKI.
OBJECTIVES


The current study aimed to address the correlation between MI/R induced AKI with ER stress and to assess the effects of dexmedetomidine pretreatment on AKI protection.
METHOD


Patients selected for heart valve replacement surgery were randomly assigned to NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine). Rat MI/R model was induced by occluding coronary artery for 30 min followed by 48-hour reperfusion. Rats were randomized into Sham (0.9% NaCl), I/R (MI/R + 0.9% NaCl) and I/R + DEX (MI/R + dexmedetomidine). Organ function and ER stress condition were evaluated by blood chemistry, pathology, and molecular test.
RESULTS


Clinical data indicated dexmedetomidine pretreatment attenuated AKI and oxidative stress as well as postischemic myocardial injury in patients. Accordingly animal results suggested dexmedetomidine reduced cellular injury and improved postischemic myocardial and renal function. Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
CONCLUSIONS


These results suggested that dexmedetomidine pretreatment attenuates MI/R injury-induced AKI by relieving the ER stress.",2020,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","['Patients undergoing', 'Patients selected for heart valve replacement surgery', 'human and rat']","['cardiopulmonary bypass (CPB', 'NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine', 'Dexmedetomidine', '\u202fDEX (MI/R\u202f+\u202fdexmedetomidine', 'dexmedetomidine']","['MI/R injury-induced AKI', 'Endoplasmic reticulum (ER) stress', 'AKI and oxidative stress', 'myocardial and renal cells apoptosis and down-regulated ER stress', 'cellular injury and improved postischemic myocardial and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0014239', 'cui_str': 'Endoplasmic reticulum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0396497,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: chaolt@ustc.edu.cn.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesia, Critical Care & Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02144, USA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency, Huashan Hospital North, Fudan University, Shanghai, 201907, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Xinghan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Clinical Laboratory, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230000, Anhui, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: xiaoqingchai@163.com.'}]",Life sciences,['10.1016/j.lfs.2020.118004']
2139,32622071,Delta-like 1 (DLK1) is a possible mediator of vitamin D effects on bone and energy metabolism.,"Vitamin D effects on bone and mineral metabolism are well recognized, and its anti-inflammatory actions are gaining particular interest. Delta-like 1 (DLK1) is a protein, expressed by progenitor cells of different tissues, and increases the size of progenitor cell population during the inflammatory phase of tissue regeneration. DLK1 also plays a role in energy metabolism as it antagonizes insulin signaling in bone. In this one-year randomized clinical trial of overweight elderly individuals that received either 600 or 3750 IU daily cholecalciferol we assessed the effect of vitamin D supplementation on pre-specified secondary outcomes: DLK1, leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM). We also examined correlations between DLK1 and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers. Multivariate analyses were conducted to further explore these associations. Overall, there was a significant increase in serum DLK1 and leptin and a decrease in VCAM, but no change in CRP, after 12 months of vitamin D supplementation. DLK1 was negatively correlated with BMD and positively correlated with bone markers, associations that persisted after adjusting for age, gender and BMI. DLK1 was also positively associated with indices of insulin resistance and negatively with indices of insulin sensitivity. Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent. There were no correlations between DLK1 and inflammatory markers. In conclusion, twelve months supplementation of vitamin D3 increased serum DLK1. DLK1 was negatively associated with indices of bone health and fuel metabolism, and with 1,25(OH) 2 D levels. Similar to the role of DLK1 in animal models, our findings support the hypothesis that DLK1 can be targeted to regulate bone and energy metabolism and develop drugs to improve BMD and insulin sensitivity. However, further studies are needed to explore the role of DLK1 and its relationship to vitamin D metabolites in vivo.",2020,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.",['overweight elderly individuals'],"['Vitamin D', 'Delta-like 1 (DLK1', '600 or 3750\u202fIU daily cholecalciferol', 'vitamin D supplementation', 'vitamin D3']","['bone health and fuel metabolism, and with 1,25(OH) 2 D levels', 'serum DLK1 and leptin', 'serum DLK1', 'DLK1 and inflammatory markers', 'DLK1', 'BMD and insulin sensitivity', 'leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM', 'VCAM', 'DLK1and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers', 'bone and mineral metabolism', 'insulin resistance and negatively with indices of insulin sensitivity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517746', 'cui_str': '3750'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0714769,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Bassatne', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Jafari', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Cellular and Molecular Medicine, Novo Nordisk Foundation Center for Stem Cell Biology (DanStem), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Moustapha', 'Initials': 'M', 'LastName': 'Kassem', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Rahme', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'El-Hajj Fuleihan', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: gf01@aub.edu.lb.'}]",Bone,['10.1016/j.bone.2020.115510']
2140,32622871,Treatment of postmenopausal osteoporosis with bone-forming and antiresorptive treatments: Combined and sequential approaches.,"Efficient therapies are available for the treatment of osteoporosis. Bisphosphonates and denosumab are the most commonly used antiresorptive therapies. Despite differences in the increase in bone mineral density seen with these drugs, the reductions in fracture risk are similar; 50-70%, 20%, and 40% for vertebral, non-vertebral and hip fractures, respectively. The bone-forming treatments; teriparatide and abaloparatide increase bone mineral density more than the antiresorptives and the reductions in fracture risk are 85% and 40-50% for vertebral and non-vertebral fractures, respectively, compared to placebo. The VERO study demonstrated a >50% reduction in vertebral and clinical fractures in women treated with teriparatide compared to risedronate. The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years. The evidence for combination therapy targeting both resorption and formation is limited as only short-term studies with BMD as the endpoint have been performed. All bone-forming and dual-action treatments increase BMD and reduce the fracture risk, however, the effect wears off with time and treatment is therefore only temporary and should be followed by antiresorptive treatment with a bisphosphonate or denosumab. The sequence of treatment matters as the BMD response to teriparatide is reduced in patients previously treated with bisphosphonates; however, based on the findings of the VERO trial, the anti-fracture efficacy of bone-forming treatment in comparison with risedronate seems to be preserved after bisphosphonate therapy. The DATA study suggested that transitioning from denosumab to teriparatide is problematic due to the increase in bone resorption occurring after stopping denosumab. Studies have shown further improvements in BMD when transitioning from oral bisphosphonates to zoledronic acid or denosumab. Management of osteoporosis will in many patients include a long-term treatment plan. This will often include sequential therapy which in severe cases preferably should start with bone-forming followed by antiresorptive treatment. The severity of osteoporosis, reaching a treatment goal, and responding to treatment failure are important factors determining the treatment sequence in the individual patient.",2020,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","['patients previously treated with', 'postmenopausal osteoporosis with bone-forming and antiresorptive treatments']","['teriparatide', 'zoledronic acid or denosumab', 'Bisphosphonates and denosumab', 'bisphosphonates', 'alendronate', 'bisphosphonate or denosumab', 'risedronate', 'placebo']","['bone mineral density', 'vertebral and clinical fractures', 'risk of vertebral, non-vertebral and hip fractures', 'BMD', 'risk of vertebral and clinical fractures', 'fracture risk', 'BMD response', 'bone resorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C1286272', 'cui_str': 'Form of bone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",,0.0195905,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","[{'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Endocrinology and Internal Medicine, Palle Juul Jensen Boulevard 115, DK8200 Aarhus N, Denmark. Electronic address: bente.langdahl@aarhus.rm.dk.'}]",Bone,['10.1016/j.bone.2020.115516']
2141,32623510,"Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial.","PURPOSE


To investigate the efficacy and safety of bencycloquidium bromide nasal spray (BCQB) in patients with persistent allergic rhinitis (PAR).
METHODS


We enrolled 720 patients from 15 hospitals across China and randomly assigned them into BCQB group or placebo group (90 μg per nostril qid) to receive a 4-week treatment. Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day. Anterior rhinoscopy scoring was completed by doctors on every visit. Adverse events were recorded in detail.
RESULTS


A total of 354 and 351 patients were included in BCQB group and in placebo group. Baseline information was comparable. At the end of the trial, the decrease of VAS for rhinorrhea from baseline was 4.83 ± 2.35 and 2.46 ± 2.34 in BCQB group and placebo group, respectively (P < 0.001). The change ratio from baseline of VAS for rhinorrhea in BCQB group was 72.32%, higher than 31.03% in placebo group (P < 0.001). VAS for other symptoms and overall symptoms also improved significantly in the BCQB group, while no inter-group difference was found in anterior rhinoscopy scoring. The incidence of adverse reaction was similar between the two groups. Most reactions were mild and no severe reactions happened.
CONCLUSION


90 μg BCQB per nostril four times daily is effective and safe in the treatment of rhinorrhea as well as sneezing, nasal congestion and itching for patients with PAR.
RETROSPECTIVELY REGISTERED


ChiCTR2000030924, 2020/3/17.",2020,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","['A total of 354 and 351 patients were included in BCQB group and in placebo group', 'persistent allergic rhinitis', 'patients with PAR', '720 patients from 15 hospitals across China and randomly assigned them into', 'patients with persistent allergic rhinitis (PAR']","['BCQB', 'VAS', 'Bencycloquidium bromide nasal spray', 'BCQB group or placebo', 'bencycloquidium bromide nasal spray (BCQB', 'placebo']","['change ratio from baseline of VAS for rhinorrhea', 'Adverse events', 'VAS for rhinorrhea', 'incidence of adverse reaction', 'Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",720.0,0.566384,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","[{'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Shixi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'He', 'Affiliation': ""Department of Otorhinolaryngology, Sichuan Provincial People's Hospital, Chengdu, 610072, People's Republic of China.""}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology, Southwest Hospital, Army Medical University, 30 Gaotan Yan St, Chongqing, 400038, People's Republic of China.""}, {'ForeName': 'Qinna', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, People's Republic of China.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology, Daping Hospital, Army Medical University, Chongqing, 400042, People's Republic of China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Otolaryngology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530021, People's Republic of China.""}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Otorhinolaryngology, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People's Republic of China.""}, {'ForeName': 'Xuping', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Hunan Provincial People's Hospital, Changsha, 410005, People's Republic of China.""}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': ""Department of Otolaryngology, Qingdao Municipal Hospital, Qingdao, Shandong, 266011, People's Republic of China.""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Dong', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Shanghai General Hospital, College of Medicine, Shanghai Jiao Tong University, Shanghai, 200080, People's Republic of China.""}, {'ForeName': 'Yongwang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Otolaryngology, The Second Hospital of Tianjin Medical University, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Lian', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, The First People's Hospital, Yangzhou, 225001, People's Republic of China.""}, {'ForeName': 'Guolin', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, 410013, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Health, Statistics, Faculty of Medical Service, Second Military Medical University, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Yingu Pharmaceutical Co., Ltd, Beijing, 100190, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China. mjmelinda@163.com.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06183-5']
2142,32644148,Evaluation of Month-24 Efficacy and Safety of Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration: The MERLOT Randomized Clinical Trial.,"Importance


Although anti-vascular endothelial growth factor (VEGF) treatment offers better outcomes than the natural history of neovascular age-related macular degeneration (ARMD), a less burdensome, less expensive, and more durable treatment is needed.
Objective


To assess the efficacy and safety of epimacular brachytherapy (EMB) for chronic, active, neovascular ARMD.
Design, Setting, and Participants


The Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis) Only Treatment (MERLOT) pivotal device trial was conducted at 24 National Health Service hospitals across the UK. Patients who had neovascular ARMD and received intravitreal ranibizumab were enrolled between November 10, 2009, and January 30, 2012. Eligible patients were randomized 2:1 and were stratified by lens status and angiographic lesion type to receive either EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy. Participants were followed up monthly for 24 months and then assessed at a final visit at month 36. Masking of participants and clinicians was not possible, but best-corrected visual acuity (BCVA) and imaging were analyzed by masked assessors. Analysis followed the intent-to-treat approach.
Interventions


Pars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab vs as-needed ranibizumab monotherapy.
Main Outcomes and Measures


Coprimary outcomes were the number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters. Secondary outcomes were the percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters and the mean change in angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography.
Results


Of 363 participants, 329 (90.6%) completed 24 months of follow-up (222 participants in the EMB group and 107 in the ranibizumab group). The mean (SD) age of the combined groups was 76.5 (7.4) years. The mean (SD) number of ranibizumab injections was 9.3 (6.7) in the EMB group and 8.3 (4.5) in the ranibizumab group, with a difference of 1.0 injection (95% CI, -0.3 to 2.3; P = .13). The mean (SD) BCVA change was -11.2 (15.7) ETDRS letters in the EMB group and -1.4 (10.9) ETDRS letters in the ranibizumab group, with a difference of 9.8 ETDRS letters (95% CI, -6.7 to -12.9). In the EMB group, 65.6% of participants (160 of 244) lost fewer than 15 ETDRS letters vs 86.6% (103 of 119) in the ranibizumab group, with a difference of 21% (95% CI, 12.4%-29.5%; P < .001). Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group. These abnormalities occurred outside the foveal center, and there were no unexpected safety concerns.
Conclusions and Relevance


The MERLOT trial found that despite the acceptable safety of EMB, it did not reduce the number of ranibizumab injections and was associated with worse visual acuity than anti-VEGF treatment alone; these results do not support EMB use as an adjunct treatment for chronic, active neovascular ARMD.
Trial Registration


ClinicalTrials.gov Identifier: NCT01006538.",2020,Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group.,"['24 National Health Service hospitals across the UK', 'Patients who had neovascular ARMD and received', '363 participants, 329 (90.6', 'Eligible patients', 'Previously Treated Neovascular Age-Related Macular Degeneration']","['Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis', 'EMB', 'ranibizumab', 'Epimacular Brachytherapy', 'epimacular brachytherapy (EMB', 'intravitreal ranibizumab', 'Interventions\n\n\nPars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab', 'anti-vascular endothelial growth factor (VEGF) treatment', 'EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy']","['visual acuity', 'percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters', 'mean (SD) number of ranibizumab injections', 'angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography', 'Microvascular abnormalities', 'efficacy and safety', 'number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters', 'mean (SD) BCVA change']","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.358324,Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group.,"[{'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Jackson', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Soare', 'Affiliation': ""Department of Ophthalmology, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Petrarca', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Neffendorf', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Petrarca', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""NetwORC UK, Central Angiographic Reading Center, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Reading Center, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""NetwORC UK, Central Angiographic Reading Center, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Membrey', 'Affiliation': 'Department of Ophthalmology, Maidstone Hospital, Maidstone, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Department of Ophthalmology, Bristol Eye Hospital, Bristol, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Costen', 'Affiliation': 'Department of Ophthalmology, Hull and East Yorkshire Eye Hospital, Hull, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steel', 'Affiliation': 'Vitreoretinal Unit, Sunderland Eye Infirmary, Sunderland, United Kingdom.'}, {'ForeName': 'Riti', 'Initials': 'R', 'LastName': 'Desai', 'Affiliation': ""Department of Ophthalmology, King's College Hospital, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2309']
2143,32647277,Effectiveness of antimuscarinics and a beta-3 adrenoceptor agonist in patients with overactive bladder in a real-world setting.,"Both antimuscarinics and beta-3 adrenoceptor agonists are generally used as first-line pharmacotherapy for overactive bladder (OAB). This study aimed to investigate the differences in clinical characteristics and manifestations between different medication groups using real-world data. In this retrospective study, we recruited all patients aged > 18 years diagnosed with OAB at our institute from March 2010 to December 2017. They were allocated into three groups, the antimuscarinics (group A), beta-3 adrenoceptor agonist (group B), and discontinued (group C) treatment groups, and they completed OAB symptom score and quality of life questionnaires before and after treatment. In addition, the Clinical Global Impression was recorded for treatment outcomes. A premedication urodynamic study was also applied. A total of 215 patients were analyzed (group A: 43, B: 35, C: 137). Group B was significantly older (mean age 77.4 years) than group A (69.2 years, p = 0.012) and group C (68.6 years, p = 0.001). However, there were no significant differences in sex or underlying diseases among the groups. Before treatment, there were no significant differences in the questionnaire results among all groups. The cystometric capacity of group A (mean ± SD, 257.3 ± 135.1 cm 3 ) was significantly larger than that of group B (125.8 ± 46.0 cm 3 , p = 0.002) and group C (170.5 ± 99.2 cm 3 , p = 0.001). After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study. However, there were no significant differences in effectiveness between the patients who took antimuscarinics and those who took a beta-3 adrenoceptor agonist.",2020,"After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study.","['patients with overactive bladder in a real-world setting', 'patients aged >\u200918\xa0years diagnosed with OAB at our institute from March 2010 to December 2017', '215 patients were analyzed (group A: 43, B: 35, C: 137']","['antimuscarinics and a beta-3 adrenoceptor agonist', 'beta-3 adrenoceptor agonist']","['cystometric capacity', 'Clinical Global Impression', 'cystometric bladder capacity', 'OAB symptom score and quality of life questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C3252518', 'cui_str': 'ADRB3 protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0429807', 'cui_str': 'Bladder capacity'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",215.0,0.0182709,"After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study.","[{'ForeName': 'Chiung-Kun', 'Initials': 'CK', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC.'}, {'ForeName': 'Chih-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC. jayslylin@gmail.com.'}, {'ForeName': 'Alex Tong-Long', 'Initials': 'AT', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC.'}]",Scientific reports,['10.1038/s41598-020-68170-4']
2144,32619656,Endoscopic debridement for non-insertional Achilles tendinopathy with and without platelet-rich plasma.,"BACKGROUND


When non-operative management fails to improve symptoms in patients with non-insertional Achilles tendinopathy, surgery may be required. Various open and endoscopic techniques have been proposed, and platelet-rich plasma (PRP) injections have been proposed as an adjunct to aid tendon healing.
METHODS


Thirty-six patients with mid-portion Achilles tendinopathy were randomized to undergo endoscopic debridement alone (n = 19) or in combination with intraoperative PRP application (n = 17). Clinical outcome measures included the Visual Analogue Scale for pain, function and satisfaction and the VISA-A questionnaire (Victorian Institute of Sports Assessment - Achilles). Patients were followed-up at 6 weeks, 3 months, 6 months, and 12 months after surgery. An MRI examination at 3 and 12 months was used to assess signal alterations within the tendon.
RESULTS


Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups. Tendon diameter increased at 3 months and decreased at 12 months. The tendinopathy area increased at 3 months and decreased at 12 months below baseline level in both groups. There was no significant difference between the groups regarding the MRI parameters. Nodular thickening and MRI-detected signal alteration persisted after surgery, with no association between imaging and clinical outcome. Five minor complications were reported: 2 in the PRP group and 3 in the control group.
CONCLUSION


Endoscopic debridement of the Achilles tendon improved clinical outcomes in patients with mid-portion tendinopathy. The addition of PRP did not improve outcomes compared to debridement alone. MRI parameters showed no association with clinical outcomes.",2020,"Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups.","['patients with mid-portion tendinopathy', 'patients with non-insertional Achilles tendinopathy', 'Thirty-six patients with mid-portion Achilles tendinopathy']","['Endoscopic debridement', 'PRP', 'endoscopic debridement alone (n\u202f=\u202f19) or in combination with intraoperative PRP application']","['clinical outcomes', 'MRI parameters', 'Tendon diameter', 'Visual Analogue Scale (VAS) for pain, function and satisfaction and the VISA-A questionnaire (Victorian Institute of Sports Assessment - Achilles', 'tendinopathy area', 'Nodular thickening and MRI-detected signal alteration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C3838916', 'cui_str': 'Non-insertional Achilles tendinopathy'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",36.0,0.0569791,"Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups.","[{'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Thermann', 'Affiliation': 'HKF-International Center for Hip, Foot and Knee Surgery, Bismarckstraße 9-15, 69115 Heidelberg, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'HKF-International Center for Hip, Foot and Knee Surgery, Bismarckstraße 9-15, 69115 Heidelberg, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Gougoulias', 'Affiliation': 'Footsurgery Clinic, 54631 Thessaloniki, Greece.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Cipollaro', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno 89100, Italy; Department of Medicine, Surgery and Dentistry, University of Salerno, Via S. Allende, 84081 Baronissi (SA), Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno 89100, Italy; Department of Medicine, Surgery and Dentistry, University of Salerno, Via S. Allende, 84081 Baronissi (SA), Italy; Centre for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, Mile End Hospital, 275 Bancroft Road, London E1 4DG, Queen Mary University of London, London, United Kingdom; School of Pharmacy and Bioengineering, Keele University Faculty of Medicine, Thornburrow Drive, Stoke on Trent, United Kingdom. Electronic address: n.maffulli@qmul.ac.uk.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.06.012']
2145,32619694,Alpha frequency rTMS modulates theta lagged nonlinear connectivity in dorsal attention network.,"Dorsolateral prefrontal cortex (DLPFC) is a key structure in dorsal attention network (DAN) that facilitates sustained attention by modulating activity in task related and unrelated regions of the brain. Alpha and theta frequency bands enhance connectivity among different parts of the attention network and these connections are facilitated by long-range nonlinear connectivity in theta and alpha frequency bands. This study is an investigation of the behavioral and electrophysiological effects of alpha and theta frequency repetitive transcranial magnetic stimulation (rTMS) over RDLPFC. 20 healthy participants were randomly assigned to two groups of theta (n = 11, f = 6 Hz) and alpha (n = 9, f = 10 Hz) rTMS. Electroencephalogram (EEG) was recorded before and after each session while resting and performing tasks. Current source density (CSD) and functional connectivity (FC) in DAN and default mode network (DMN) and their correlations with rapid visual information processing task (RVIP) scores were calculated . Alpha frequency rTMS resulted in significant changes in RVIP scores. Active theta rTMS caused an increase in CSD in Postcentral gyrus and active alpha rTMS resulted in significant CSD changes in inferior parietal lobule (IPL). Theta lagged nonlinear connectivity was mudulated by alpha rTMSand FC changes were observed in DAN and DMN. Positive correlations were observed between DAN regions and RVIP scores in the alpha rTMS group. Increased activity in theta frequency band in left aPFC and left DLPFC correlated positively with higher total hits in RVIP. This study showed for the first time that theta and alpha frequency rTMS are able to modulate FC in DAN and DMN in a way that results in better performance in a sustained attention task.",2020,Active theta rTMS caused an increase in CSD in Postcentral gyrus and active alpha rTMS resulted in significant CSD changed in inferior parietal lobule (IPL).,['20 healthy participants'],"['alpha and theta repetitive transcranial magnetic stimulation (rTMS', 'Alpha Frequency rTMS', 'Active alpha rTMS', 'alpha (n\u2009=\u20099, f\u2009=\u20096\u2009Hz) rTMS']","['rapid visual information processing task (RVIP) scores', 'Electroencephalogram (EEG', 'RVIP scores', 'FC changes', 'CSD', 'Current source density (CSD) and functional connectivity (FC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",20.0,0.0387473,Active theta rTMS caused an increase in CSD in Postcentral gyrus and active alpha rTMS resulted in significant CSD changed in inferior parietal lobule (IPL).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kazemi', 'Affiliation': 'Cognitive Lab, Department of Psychology, University of Tehran, Tehran, Iran; Atieh Clinical Neuroscience Center, Tehran, Iran. Electronic address: rezakazemi@ut.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rostami', 'Affiliation': 'Department of Psychology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Shouka', 'Initials': 'S', 'LastName': 'Dehghan', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Nasiri', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Lotfollahzadeh', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Abed', 'Initials': 'A', 'LastName': 'L Hadipour', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran; Department of Psychology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Khomami', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Ryouhei', 'Initials': 'R', 'LastName': 'Ishii', 'Affiliation': 'Smart Rehabilitation Research Center, Osaka Prefecture University, Graduate School of Comprehensive Rehabilitation, Habikino, Japan; Department of Psychiatry, Osaka University, Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}]",Brain research bulletin,['10.1016/j.brainresbull.2020.06.018']
2146,32621644,"A double-blind, randomized, placebo-controlled pilot trial of atorvastatin for nephrogenic diabetes insipidus in lithium users.","OBJECTIVE


Lithium remains an important treatment for mood disorders but is associated with kidney disease. Nephrogenic diabetes insipidus (NDI) is associated with up to 3-fold risk of incident chronic kidney disease among lithium users. There are limited randomized controlled trials (RCT) for treatments of lithium-induced NDI, and existing therapies can be poorly tolerated. Therefore, novel treatments are needed for lithium-induced NDI.
METHOD


We conducted a 12-week double-blind pilot RCT to assess the feasibility and efficacy of 20 mg/d atorvastatin vs placebo in the treatment of NDI in chronic lithium users. Patients, recruited between September 2017 and October 2018, were aged 18 to 85, currently on a stable dose of lithium, and determined to have NDI.
RESULTS


Urinary osmolality (UOsm) at 12 weeks adjusted for baseline was not statistically different between groups (+39.6 mOsm/kg [95% CI, -35.3, 114.5] in atorvastatin compared to placebo groups). Secondary outcomes of fluid intake and aquaporin-2 excretions at 12 weeks adjusted for baseline were -0.13 L [95% CI, -0.54, 0.28] and 98.68 [95% CI, -190.34, 387.70], respectively. A moderate effect size was observed for improvements in baseline UOsm by ≥100 mOsm/kg at 12 weeks in patients who received atorvastatin compared to placebo (38.45% (10/26) vs 22.58% (7/31); Cohen's d = 0.66).
CONCLUSION


Among lithium users with NDI, atorvastatin 20 mg/d did not significantly improve urinary osmolality compared to placebo over a 12-week period. Larger confirmatory trials with longer follow-up periods may help to further assess the effects of statins on NDI, especially within patients with more severe NDI.",2020,"A moderate effect size was observed for improvements in baseline UOsm by ≥100mOsm/Kg at 12 weeks in patients who received atorvastatin compared to placebo (38.45% (10/26) vs. 22.58% (7/31); Cohen's d = 0.66).
","['Nephrogenic Diabetes Insipidus in Lithium-Users', 'Patients, recruited between September 2017 and October 2018, were aged 18 to 85, currently on a stable dose of lithium, and determined to have NDI', 'chronic lithium users', 'patients with more severe NDI']","['atorvastatin', 'Nephrogenic diabetes insipidus (NDI', 'Placebo', 'NDI, atorvastatin', 'Atorvastatin', 'atorvastatin vs. placebo', 'placebo']","['feasibility and efficacy', 'urinary osmolality', 'fluid intake and aquaporin-2 excretions', 'Urinary osmolality (UOsm']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0213238', 'cui_str': 'Aquaporin-2'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.535592,"A moderate effect size was observed for improvements in baseline UOsm by ≥100mOsm/Kg at 12 weeks in patients who received atorvastatin compared to placebo (38.45% (10/26) vs. 22.58% (7/31); Cohen's d = 0.66).
","[{'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Fotso Soh', 'Affiliation': 'Geri-PARTy Research Group, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Beaulieu', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Trepiccione', 'Affiliation': 'Division of Nephrology, University of Naples, Naples, Italy.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Linnaranta', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Torres-Platas', 'Affiliation': 'Geri-PARTy Research Group, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Platt', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Suzane', 'Initials': 'S', 'LastName': 'Renaud', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Su', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Mucsi', 'Affiliation': 'Division of Nephrology, University Health Network, University of Toronto (UofT), Toronto, ON, Canada.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': ""D'Apolito"", 'Affiliation': 'Biogem S.c.a.r.l., Istituto di Ricerche Genetiche ""Gaetano Salvatore"", Ariano Irpino, Italy.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sybille', 'Initials': 'S', 'LastName': 'Saury', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ayal', 'Initials': 'A', 'LastName': 'Schaffer', 'Affiliation': 'Department of Psychiatry, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Dols', 'Affiliation': 'Amsterdam UMC, Department of Psychiatry, GGZinGeest, Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Low', 'Affiliation': 'Department of Psychiatry, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Cervantes', 'Affiliation': 'Department of Psychiatry, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Birgitte M', 'Initials': 'BM', 'LastName': 'Christensen', 'Affiliation': 'Department of Biomedicine, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Department of Psychiatry, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Rajji', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Soham', 'Initials': 'S', 'LastName': 'Rej', 'Affiliation': 'Geri-PARTy Research Group, Jewish General Hospital, Montreal, QC, Canada.'}]",Bipolar disorders,['10.1111/bdi.12973']
2147,32622225,The impact of adult trauma triage training on decision-making skills and accuracy of triage decision at emergency departments in Malaysia: A randomized control trial.,"INTRODUCTION


Patients who visit emergency departments need to undergo a precise assessment to determine their priority and accurate triage category to ensure they receive the right treatment.
AIM


To identify the effect of triage training on the skills and accuracy of triage decisions for adult trauma patients.
METHOD


A randomized controlled trial design was conducted in ten emergency department of public hospitals. A total of 143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n = 74) and the intervention group (n = 69). The skill and accuracy of triage decisions were measured two weeks and four weeks after the intervention group were exposed to the intervention.
RESULTS


There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31. Concerning the accuracy of triage decisions, the effect was significantly different between the control group and the intervention group p < 0.001, η 2 partial  = 0.66 across time.
CONCLUSION


The triage training improved the skills of the participants and the accuracy of triage decision-making across time.",2020,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31.","['emergency departments in Malaysia', 'Patients who visit emergency departments', 'ten emergency department of public hospitals', '143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n\xa0=\xa074) and the intervention group (n\xa0=\xa069', 'adult trauma patients']","['triage training', 'adult trauma triage training']","['skill and accuracy of triage decisions', 'skill of triage decision-making']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0557516', 'cui_str': 'Medical officer'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",143.0,0.0515258,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31.","[{'ForeName': 'Siti Aishah', 'Initials': 'SA', 'LastName': 'Ghazali', 'Affiliation': 'School of Health Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia; Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: schah@usm.my.'}, {'ForeName': 'Khatijah Lim', 'Initials': 'KL', 'LastName': 'Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: katlim@um.edu.my.'}, {'ForeName': 'Foong Ming', 'Initials': 'FM', 'LastName': 'Moy', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: moyfm@ummc.edu.my.'}, {'ForeName': 'Rashidi', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Department of Emergency Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: rashidi@ummc.edu.my.'}, {'ForeName': 'Emni Omar Daw', 'Initials': 'EOD', 'LastName': 'Hussin', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.'}]",International emergency nursing,['10.1016/j.ienj.2020.100889']
2148,32622294,The effects of yoga on functionality appreciation and additional facets of positive body image.,"This study investigated the effects of yoga on functionality appreciation, and the potential mechanisms that could explain the impact of yoga on additional facets of positive body image. Young adult women (N = 114; M age  = 22.19) were randomised to a 10-week Hatha yoga programme or waitlist control group. Participants completed measures of functionality appreciation, body appreciation, body compassion, appearance evaluation, self-objectification, and embodiment at Pretest, Midtest, Posttest, and 1-month Follow-Up. Follow-up data could not be analysed due to high levels of attrition. The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time. Further, all participants experienced improvements in body appreciation, body compassion, and appearance evaluation over time, regardless of their assigned group. Lower self-objectification contributed to improvements in body appreciation and body compassion. In addition, greater embodiment contributed to improvements in body appreciation, body compassion, and appearance evaluation. Contrary to our expectations, yoga did not lead to increased functionality appreciation, nor was functionality appreciation a mediator of the impact of yoga on positive body image. Instead, lower self-objectification, and greater embodiment, drove improvements in positive body image.",2020,"The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time.",['Young adult women (N\u202f=\u202f114; M age \u202f=\u202f22.19'],['Hatha yoga programme or waitlist control group'],"['body appreciation and body compassion', 'functionality appreciation, body appreciation, body compassion, appearance evaluation, self-objectification, and embodiment at Pretest, Midtest, Posttest, and 1-month Follow-Up', 'body appreciation, body compassion, and appearance evaluation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0268438,"The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Alleva', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands. Electronic address: Jessica.Alleva@maastrichtuniversity.nl.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Tylka', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Oorsouw', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Montanaro', 'Affiliation': 'Department of Psychology, The University of North Carolina at Charlotte, Charlotte, NC, United States.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Perey', 'Affiliation': 'Chair of Sport and Health Management, Technical University of Munich, Germany.'}, {'ForeName': 'Cheyenne', 'Initials': 'C', 'LastName': 'Bolle', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jantine', 'Initials': 'J', 'LastName': 'Boselie', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, The University of North Carolina at Charlotte, Charlotte, NC, United States.'}]",Body image,['10.1016/j.bodyim.2020.06.003']
2149,32627605,"Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial.","Cancer patients have a 2 times higher prevalence of insomnia than healthy populations and cancer-related insomnia has received minimal attention while insomnia can aggravate the rehabilitation of cancer patients. Cheonwangbosimdan is a Korean herbal medicine generally used to relieve sleep deprivation, however, few studies presented the effects of Cheonwangbosimdan on cancer-related insomnia. The purpose of study is to examine the feasibility of Cheonwangbosimdan treatments for cancer patients. Twenty-two participants were allocated into a Cheonwangbosimdan or cognitive-behavioral therapy for insomnia (CBT-I) control group by equal number. The intervention group took Cheonwangbosimdan liquid once in a day and attend visits once a week for 4 weeks. The CBT-I group underwent individualized behavioral therapy 4 times in 4 weeks. The primary outcome is changes in the Insomnia Severity Index (ISI) from baseline to the end of the trial. Responses to the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Zung Self-Rating Anxiety Scale (SAS), Brief Fatigue Inventory (BFI), Euroqol-5 Dimensions-5 Levels (EQ-5D-5L), and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) were secondary outcomes used to evaluate the quality of sleep. Outcomes were measured at a follow-up visit (visit 5) in the fifth week of the trial. There is no difference between 2 groups, but both groups showed tendency to alleviate cancer insomnia symptoms. SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score. The study can contribute to more attentive care for insomnia in cancer patients.",2020,"SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score.","['cancer patients', 'Cancer Patients', 'Cancer patients']","['Cheonwangbosimdan', 'Cheonwangbosimdan (Tian Wang Bu Xin Dan', 'Cheonwangbosimdan liquid', 'Cognitive-Behavioral Therapy', 'Cheonwangbosimdan or cognitive-behavioral therapy for insomnia (CBT-I) control group by equal number', 'individualized behavioral therapy']","['quality of sleep', 'Insomnia Severity Index (ISI', 'Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Zung Self-Rating Anxiety Scale (SAS), Brief Fatigue Inventory (BFI), Euroqol-5 Dimensions-5 Levels (EQ-5D-5L), and Eastern Cooperative Oncology Group Performance Status (ECOG-PS', 'alleviate cancer insomnia symptoms']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0451595', 'cui_str': ""Zung's self-rating anxiety scale""}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",22.0,0.0309818,"SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score.","[{'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Moon', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Ui Min', 'Initials': 'UM', 'LastName': 'Jerng', 'Affiliation': 'Sang-ji University Korean Medicine Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'O-Jin', 'Initials': 'OJ', 'LastName': 'Kwon', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jee Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Woo', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Chul', 'Initials': 'WC', 'LastName': 'Shin', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Ick', 'Initials': 'JI', 'LastName': 'Byun', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Jun-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}]",Integrative cancer therapies,['10.1177/1534735420935643']
2150,32627890,"Impaired pulmonary gas exchange efficiency, but normal pulmonary artery pressure increases, with hypoxia in men and women with a patent foramen ovale.","NEW FINDINGS


What is the central question of this study? Do individuals with a patent foramen ovale (PFO +  ) have a larger alveolar-to-arterial difference in  P   O   2      (    A   -   a   D   O   2        ) than those without (PFO -  ) and/or an exaggerated increase in pulmonary artery systolic pressure (PASP) in response to hypoxia? What is the main finding and its importance? PFO +  had a greater    A   -   a   D   O   2        while breathing air, 16% and 14% O 2  , but not 12% or 10% O 2  . PASP increased equally in hypoxia between PFO +  and PFO -  . These data suggest that PFO +  may not have an exaggerated acute increase in PASP in response to hypoxia.
ABSTRACT


Patent foramen ovale (PFO) is present in 30-40% of the population and is a potential source of right-to-left shunt. Accordingly, those with a PFO (PFO +  ) may have a larger alveolar-to-arterial difference in  P   O   2      (    A   -   a   D   O   2        ) than those without (PFO -  ) in normoxia and with mild hypoxia. Likewise, PFO is associated with high-altitude pulmonary oedema, a condition known to have an exaggerated pulmonary pressure response to hypoxia. Thus, PFO +  may also have exaggerated pulmonary pressure increases in response to hypoxia. Therefore, the purposes of the present study were to systematically determine whether or not: (1) the    A   -   a   D   O   2        was greater in PFO +  than in PFO -  in normoxia and mild to severe hypoxia and (2) the increase in pulmonary artery systolic pressure (PASP) in response to hypoxia was greater in PFO +  than in PFO -  . We measured arterial blood gases and PASP via ultrasound in healthy PFO +  (n = 15) and PFO -  (n = 15) humans breathing air and 30 min after breathing four levels of hypoxia (16%, 14%, 12%, 10% O 2  , randomized and balanced order) at rest. The    A   -   a   D   O   2        was significantly greater in PFO +  compared to PFO -  while breathing air (2.1 ± 0.7 vs. 0.4 ± 0.3 Torr), 16% O 2  (1.8 ± 1.2 vs. 0.7 ± 0.8 Torr) and 14% O 2  (2.3 ± 1.2 vs. 0.7 ± 0.6 Torr), but not 12% or 10% O 2  . We found no effect of PFO on PASP at any level of hypoxia. We conclude that PFO influences pulmonary gas exchange efficiency with mild hypoxia, but not the acute increase in PASP in response to hypoxia.",2020,"PFO+ had a greater A-aDO 2  while breathing air, 16% and 14%, but not 12% or 10% O 2  .","['n\xa0=\xa015', 'men and women with a patent foramen ovale', 'individuals with a patent foramen ovale (PFO', 'healthy PFO+ (n\xa0=\xa015) and PFO']","['PFO (PFO', 'PFO', 'PASP']","['pulmonary artery systolic pressure (PASP', 'normal pulmonary artery pressure increases with hypoxia', 'arterial blood gases and PASP via ultrasound', 'PFO']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0048701', 'cui_str': '4-S-(propionic acid)sulfidocyclophosphamide'}]","[{'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0048701', 'cui_str': '4-S-(propionic acid)sulfidocyclophosphamide'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",,0.0249063,"PFO+ had a greater A-aDO 2  while breathing air, 16% and 14%, but not 12% or 10% O 2  .","[{'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Duke', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Beasley', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Julia P', 'Initials': 'JP', 'LastName': 'Speros', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Elliott', 'Affiliation': 'VA Portland Health Care System, Portland, OR, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Laurie', 'Affiliation': 'KBR, Cardiovascular and Vision Laboratory, NASA Johnson Space Center, Houston, TX, USA.'}, {'ForeName': 'Randall D', 'Initials': 'RD', 'LastName': 'Goodman', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Eben', 'Initials': 'E', 'LastName': 'Futral', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Jerold A', 'Initials': 'JA', 'LastName': 'Hawn', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Lovering', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, USA.'}]",Experimental physiology,['10.1113/EP088750']
2151,32623140,Emotion self-regulation training in major depressive disorder using simultaneous real-time fMRI and EEG neurofeedback.,"Simultaneous real-time fMRI and EEG neurofeedback (rtfMRI-EEG-nf) is an emerging neuromodulation approach, that enables simultaneous volitional regulation of both hemodynamic (BOLD fMRI) and electrophysiological (EEG) brain activities. Here we report the first application of rtfMRI-EEG-nf for emotion self-regulation training in patients with major depressive disorder (MDD). In this proof-of-concept study, MDD patients in the experimental group (n = 16) used rtfMRI-EEG-nf during a happy emotion induction task to simultaneously upregulate two fMRI and two EEG activity measures relevant to MDD. The target measures included BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz). MDD patients in the control group (n = 8) were provided with sham feedback signals. An advanced procedure for improved real-time EEG-fMRI artifact correction was implemented. The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC. Average individual FAA changes during the rtfMRI-EEG-nf task positively correlated with depression and anhedonia severities, and negatively correlated with after-vs-before changes in depressed mood ratings. Temporal correlations between the FAA and FBA time courses and the LA BOLD activity were significantly enhanced during the rtfMRI-EEG-nf task. The experimental group participants reported significant mood improvements after the training. Our results suggest that the rtfMRI-EEG-nf may have potential for treatment of MDD.",2020,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.",['patients with major depressive disorder (MDD'],"['Emotion self-regulation training', 'rtfMRI-EEG-nf for emotion self-regulation training']","['BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz', 'Average individual FAA changes', 'depression and anhedonia severities', 'LA BOLD activity', 'fMRI connectivity', 'LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.014664,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Zotev', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA. Electronic address: vzotev@laureateinstitute.org.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mayeli', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Electrical and Computer Engineering, University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Misaki', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Bodurka', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, USA. Electronic address: jbodurka@laureateinstitute.org.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102331']
2152,32623182,"Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancérologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX).","BACKGROUND


Chemotherapy is effective in metastatic pancreatic adenocarcinoma (mPA), but new approaches are still needed to improve patients' survival and quality of life. We have previously published good efficacy and tolerability results on a sequential treatment strategy of gemcitabine followed by an intensified FOLFIRI (5FU+irinotecan) regimen. In the present study, we evaluated the same sequence but replaced gemcitabine by the new gemcitabine + nab-paclitaxel standard first-line combination.
PATIENTS AND METHODS


We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status 0-2 to alternately receive gemcitabine + nab-paclitaxel for 2 months then FOLFIRI.3 for 2 months in arm A, or gemcitabine + nab-paclitaxel alone until progression in arm B. The primary objective was to increase the 6-month progression-free survival (PFS) rate from 40% (H 0 ) to 60% (H 1 ); using the binomial exact method, 124 patients were required. Analyses were carried out in preplanned modified intention-to-treat (mITT) and per-protocol (PP) populations.
RESULTS


Between November 2015 and November 2016, 127 patients were enrolled. Main grade III-IV toxicities (% in arm A/B) were: diarrhoea (12.5/1.7), neutropenia (46.9/31, including febrile neutropenia: 1.6/0), skin toxicity (6.3/13.8), and peripheral neuropathy (6.3/8.6). No toxic deaths occurred. The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm B. The primary end-point (6-month PFS rate) was 45.2% [one-sided 95% CI: 34.3-56.4] in arm A and 23.3% in arm B [one-sided 95% CI: 14.3-32.3] in the mITT population. In the PP population, median PFS and OS were 7.6 months and 6 months and 14.5 months and 12.2 months in arm A and B, respectively.
CONCLUSIONS


The FIRGEMAX strategy with gemcitabine + nab-paclitaxel alternating with FOLFIRI.3 every 2 months, appears feasible and effective, with manageable toxicities, in patients able to reach >2mo of treatment.
TRIAL REGISTRATION INFORMATION


EudraCT: 2014-004449-28: NCT: 0282701.",2020,The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm,"['We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status\xa00-2 to alternately receive', 'metastatic pancreatic adenocarcinoma (mPA', 'patients with metastatic pancreatic adenocarcinoma', 'Between November 2015 and November 2016', '127 patients were enrolled']","['gemcitabine\xa0+\xa0nab-paclitaxel', 'Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3', 'gemcitabine\xa0+\xa0nab-paclitaxel standard first-line combination', 'gemcitabine\xa0+\xa0nab-paclitaxel alone until progression in arm B', 'gemcitabine', 'gemcitabine\xa0+\xa0nab-paclitaxel alternating with FOLFIRI.3']","['peripheral neuropathy', 'toxic deaths', 'neutropenia', 'diarrhoea', 'Main grade III-IV toxicities', 'median PFS and OS', 'skin toxicity', 'objective response rate', '6-month progression-free survival (PFS) rate']","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",127.0,0.0595149,The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm,"[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': 'Department of Hepato-gastroenterology, European Hospital, Marseille, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Pointet', 'Affiliation': 'Department of Hepato-gastroenterology, Georges Pompidou European Hospital, Paris, France.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khemissa Akouz', 'Affiliation': 'Department of Hepato-gastroenterology, Saint Jean Hospital, Perpignan, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Biostatistics Department, Francophone Federation of Digestive Cancerology, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Bidaut', 'Initials': 'B', 'LastName': 'Wahiba', 'Affiliation': 'Department of Hepato-gastroenterology, European Hospital, Marseille, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Louafi', 'Affiliation': 'Department of Oncology, Sud Francilien Hospital Center, Corbeil-Essonnes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gratet', 'Affiliation': 'Oncology and Hematology ONCOSUD Unit, Clinic Pasteur, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Miglianico', 'Affiliation': 'Department of Radiotherapy, Private Hospital Center, Saint-Grégoire, France.'}, {'ForeName': 'Hortense', 'Initials': 'H', 'LastName': 'Laharie', 'Affiliation': 'Department of Oncology and Radiotherapy, Clinic Tivoli, Bordeaux, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Bouhier Leporrier', 'Affiliation': 'Department of Hepato-gastroenterology, University Hospital, Caen, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thirot Bidault', 'Affiliation': 'Department of Hepato-gastroenterology, Private Hospital, Antony, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Texereau', 'Affiliation': 'Department of Hepato-gastroenterology, Layne Hospital, Mont-De-Marsan, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Coriat', 'Affiliation': 'Department of Hepato-gastroenterology, Cochin Hospital, APHP, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Terrebonne', 'Affiliation': 'Department of Hepato-gastroenterology, Haut Lévêque Hospital, Pessac, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Gouttebel', 'Affiliation': 'Department of Oncology, Drôme Nord Hospital, Romans Sur Isère, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Department of Hepato-gastroenterology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Hepato-gastroenterology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Department of Hepato-gastroenterology, University Hospital of Dijon, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Hepato-gastroenterology, Sorbonne Paris City, Paris Descartes University, Georges Pompidou European Hospital, Paris, France. Electronic address: jtaieb75@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.018']
2153,32628620,Effect of the surgical exposure on the early postoperative period after total knee arthroplasty,"INTRODUCTION


Total knee arthroplasty has become one of the most successful and safest surgical procedures in orthopedic surgery. Of the many different types of surgical exposure, the most common, so-called medial parapatellar (MP) incision is the cut of the quadriceps tendon, which impairs extensor function. In contrast, subvastus (S) exposure, which spares the extensor apparatus, may promise better healing.
AIM


The purpose of our prospective observational study at the Orthopedic Clinic of Semmelweis University is to compare the effects of the MP and the S excision on the early postoperative period.
METHOD


The 60 patients enrolled were randomly assigned to two different groups according to the type of intervention. In the study, we measured the effects of the two different methods of surgical exposure on homogeneous patient groups in the early postoperative period based on international literature and the parameters we defined.
RESULTS


Visual analog scale (VAS) measured resting and active pain levels for the first 10 days, suggesting a more pronounced difference in active VAS values for the S group. In the case of active VAS, patients in the S group also had significantly less pain on days 2, 3, and 10 than in the MP group. Taking into account the results of the other days, it is in favour of preserving the integrity of the extensor apparatus for improved postoperative functionality. Patients' knee joint range of motion was also measured. On day 1, those in the S group were significantly larger. As the days progress, MP group members catch up with S group during their rehabilitation. Group S patients had an average of 1.944 days to extended leg elevation, which is nearly two days shorter compared to the MP group (p<0.0001).
CONCLUSIONS


After statistical analysis of data, subvastus exposure appears to be more beneficial in the rehabilitation of the early postoperative period. However, large-scale, multicentre observational studies are required to establish evidence. Orv Hetil. 2020; 161(29): 1208-1214.",2020,"In the case of active VAS, patients in the S group also had significantly less pain on days 2, 3, and 10 than in the MP group.","['Orthopedic Clinic of Semmelweis University', 'total knee arthroplasty', '2020; 161(29): 1208-1214', '60 patients enrolled']",['MP and the S excision'],"['Visual analog scale (VAS) measured resting and active pain levels', 'knee joint range of motion', 'active VAS values', 'pain']","[{'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0321759,"In the case of active VAS, patients in the S group also had significantly less pain on days 2, 3, and 10 than in the MP group.","[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Bejek', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'Holnapy', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Skaliczki', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Bence', 'Initials': 'B', 'LastName': 'Stubnya', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Szatmári', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}]",Orvosi hetilap,['10.1556/650.2020.31774']
2154,32629226,Occurrence of c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in DHCR7 gene in population of polish women with recurrent miscarriage.,"INTRODUCTION


Recurrent miscarriage is a serious clinical problem that affects 1-5 % of all couples trying to conceive. Although the incidence of Smith-Lemli-Opitz Syndrome (SLOS, OMIM #270400), an autosomal recessive condition caused by variants in the DHCR7 gene, is very low, (1:83 000), the observed carrier frequency of DHCR7 gene variants in the Polish population is high, ranging from 1:24 to 1:31. It is possible that this carriage may be responsible for early pregnancy loss.
OBJECTIVES


The aim of the study is to determine the carrier frequency of the p c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in the DHCR7 gene in patients experiencing recurrent miscarriage.
METHODS


The study group included 480 patients: a study group of 380 with at least 2 miscarriages before the 20th week of pregnancy, and a control group of 100 who had not experienced miscarriage. The variants were identified by genotyping: c.976 G>T (p.Val326Leu) by the TaqMan® SNP Genotyping Assay system, and c.452 G>A (p.Trp151Ter) using the BfaI restriction enzyme. Statistical analysis was performed using R software.
RESULTS


No examples of c.976 G>T (p.Val326Leu) were found in either group. c.452 G>A (p.Trp151Ter) was found in 22 participants from the study group and 4 from the control group; however, this difference was not significant (Chi2 test p = 0.61).
CONCLUSIONS


Being a carrier of the c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.",2020,A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.,"['population of polish women with recurrent miscarriage', 'patients experiencing recurrent miscarriage', '480 patients: a study group of 380 with at least 2 miscarriages before the 20th week of pregnancy, and a control group of 100 who had not experienced miscarriage']","['Val326Leu) and c.452 G', 'G']",[],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000809', 'cui_str': 'Recurrent miscarriage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],[],,0.0226355,A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Chrzanowska-Steglińska', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland. Electronic address: marta.chrzanowska85@interia.pl.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Moczulska', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland; Clinical Genetics Clinic, Central Clinical Hospital of the Medical University of Lodz, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Skoczylas', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Pietrusiński', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Antosik', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Jakiel', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kacprzak', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Borowiec', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sieroszewski', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.063']
2155,32629336,"The effects of a virtual learning environment compared with an individual handheld device on pharmacology knowledge acquisition, satisfaction and comfort ratings.","BACKGROUND


Virtual reality is reported to improve post-intervention knowledge and skills outcomes of health professionals compared to traditional teaching methods or digital online media. However, providing equitable access to high quality virtual reality resources for large, diverse nursing and midwifery student cohorts within multi-campus settings remains challenging.
OBJECTIVES


This study compared the effect on student learning, satisfaction and comfort following exposure to a three-dimensional pharmacology artefact in a virtual facility (CAVE2™) 1  with viewing of the same artefact using a mobile handheld device with stereoscopic lenses attached.
DESIGN


The study used a pretest-posttest design.
SETTING


School of Nursing and Midwifery in a regional university in Southeast Queensland, Australia.
PARTICIPANTS


Two hundred and forty-nine second year undergraduate nursing and midwifery students.
METHODS


Online multiple choice tests were deployed to measure knowledge acquisition. Self-reported satisfaction scores and comfort ratings were collected using questionnaires.
RESULTS


Participants were not disadvantaged in terms of knowledge acquisition by using either CAVE2™ or the mobile handheld visualisation mode (P = 0.977). Significant differences in favour of the CAVE2™ environment were found in between students' satisfaction scores for clinical reasoning (P = 0.013) and clinical learning (P < 0.001) compared to the handheld mode, and there were no significant differences in their satisfaction with debriefing and reflective practice processes (P = 0.377) related to undertaking visualisation activities. A small number of students using handheld devices with stereoscopic lenses reported greater discomfort in relation to the visualisation that negatively impacted their learning (P = 0.001).
CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.",2020,"CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.","['Two hundred and forty-nine second year undergraduate nursing and midwifery students', 'School of Nursing and Midwifery in a regional university in Southeast Queensland, Australia']","['virtual learning environment', 'stereoscopic lenses']","['Self-reported satisfaction scores and comfort ratings', 'satisfaction with debriefing and reflective practice processes', 'knowledge acquisition', 'satisfaction scores for clinical reasoning', 'clinical learning', 'pharmacology knowledge acquisition, satisfaction and comfort ratings']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]",,0.0701285,"CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hanson', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD 4558, Australia. Electronic address: jhanson@usc.edu.au.'}, {'ForeName': 'Patrea', 'Initials': 'P', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD 4558, Australia. Electronic address: panders1@usc.edu.au.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Dunn', 'Affiliation': 'School Health and Sports Science, Locked Bag 4, Maroochydore DC 4558, Australia. Electronic address: pdunn2@usc.edu.au.'}]",Nurse education today,['10.1016/j.nedt.2020.104518']
2156,32629662,Exploratory study on the safety and effectiveness of Yizhi Qingxin Decoction (capsules) in the treatment of hypertension in the elderly with mild cognitive impairment (deficiency of kidney essence syndrome).,"BACKGROUND


Hypertension in the elderly with cognitive impairment has been one of the global health issues. Mild cognitive impairment (MCI) is the state of transition between the normal aging process and cognitive changes of unformed dementia. Diagnosis and treatment of MCI are the keys to prevent dementia, and hypertension is one of the important influencing factors of MCI. Our preclinical experiment found that Yizhi Qingxin Decoction (YQD) could effectively reduce the blood pressure of spontaneously hypertensive rats (SHR), improve their spatial learning and memory abilities in Morris water maze, and play a neuroprotective role. The objective is to estimate the safety and efficacy of YQD (capsules) in the treatment of hypertension in the elderly with MCI (deficiency of kidney essence syndrome) through this study.
METHODS


According to the random number generated by the block random method, 100 participants will be randomly and equally divided into the treatment group (YQD) or the control group (Ginkgo biloba extract tablets). The conversion rate of dementia will be used as the main evaluating indicator by the CDR scale. The MoCA scale, MMSE scale, ADCS-MCI-ADL-24 scale, CGIC-KDS scale, and 24-h ambulatory blood pressure will be used as the secondary evaluating indicator. Safety will be evaluated based on specific manifestations of adverse reactions and the incidence of adverse events.
OBJECTIVE


The objective is to estimate the curative effect of YQD (capsules) on hypertension in the elderly with MCI (deficiency of kidney essence syndrome), and to evaluate the safety of its clinical application.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ICTRP member): ChiCTR2000030292.",2020,"Our preclinical experiment found that Yizhi Qingxin Decoction (YQD) could effectively reduce the blood pressure of spontaneously hypertensive rats (SHR), improve their spatial learning and memory abilities in Morris water maze, and play a neuroprotective role.","['hypertension in the elderly with mild cognitive impairment (deficiency of kidney essence syndrome', 'hypertension in the elderly with MCI (deficiency of kidney essence syndrome', 'elderly with cognitive impairment', 'spontaneously hypertensive rats (SHR', 'elderly with MCI (deficiency of kidney essence syndrome']","['Yizhi Qingxin Decoction (YQD', 'Yizhi Qingxin Decoction (capsules', 'YQD (capsules', 'control group (Ginkgo biloba extract tablets', 'MCI']","['safety and effectiveness', 'Mild cognitive impairment (MCI', 'blood pressure', 'MoCA scale, MMSE scale, ADCS-MCI-ADL-24 scale, CGIC-KDS scale, and 24-h ambulatory blood pressure']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0034705', 'cui_str': 'Spontaneously hypertensive rat'}]","[{'cui': 'C1869287', 'cui_str': 'yi-zhi'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}]",100.0,0.0229678,"Our preclinical experiment found that Yizhi Qingxin Decoction (YQD) could effectively reduce the blood pressure of spontaneously hypertensive rats (SHR), improve their spatial learning and memory abilities in Morris water maze, and play a neuroprotective role.","[{'ForeName': 'Bi-Qing', 'Initials': 'BQ', 'LastName': 'Wang', 'Affiliation': 'Clinical College, Beijing University of Chinese Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Clinical College, Beijing University of Chinese Medicine.'}, {'ForeName': 'Chun-Xiao', 'Initials': 'CX', 'LastName': 'Ju', 'Affiliation': 'Clinical College, Beijing University of Chinese Medicine.'}, {'ForeName': 'Jun-Nan', 'Initials': 'JN', 'LastName': 'Zhao', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Feng-Qin', 'Initials': 'FQ', 'LastName': 'Xu', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Ke-Ji', 'Initials': 'KJ', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}]",Medicine,['10.1097/MD.0000000000020789']
2157,32629668,"Efficacy and safety of low-dose glucocorticoids combined with methotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: A single-center, randomized, double-blind clinical trial.","INTRODUCTION


Glucocorticoids (GCs), especially low-dose GCs, are commonly prescribed for rheumatoid arthritis (RA), although the risk/benefit ratio is controversial. A randomized, double-blind clinical trial was performed to evaluate the efficacy and safety of low-dose oral GCs combined with methotrexate (MTX) and hydroxychloroquine (HCQ) in early RA (ERA).
METHODS


Eighty untreated ERA patients were randomized into the trial (GCs + MTX + HCQ) and control (placebo + MTX + HCQ) groups, for 1-year treatment. Therapeutic evaluation indices were American College of Rheumatology (ACR) 20 of ACR, disease activity score (DAS) 28- erythrocyte sedimentation rate (ESR), visual analog scale scores, joint function, health assessment questionnaire-disability index score, morning stiffness duration, C-reaction protein and ESR. The clinical indicators were evaluated pre-treatment and at 1st, 3th, 6th and 12th month of treatment. The MRI data of single joint (ie, the most swollen joint) for each patient were acquired with a revised OMERACT RAMRIS Scoring System before and after treatment. The correlation analysis was adopted to confirm whether the efficacy of GC treatment is related to the time of RA onset. The side effects (eg, gastrointestinal reactions, liver dysfunction, upper respiratory tract infection, leukocyte reduction) were also monitored.
RESULTS


At 1st month, 55% and 20% cases in the experimental and control groups achieved ACR20 response, respectively, indicating a significant difference (χ = 16.157, P < .001). This trend continued until 6th month. At 12th month, the number of patients achieved ACR20 response was similar in both groups. At 1st to 6th month, DAS28- ESR scores in the experimental group were significantly lower than control values (all p < .05). The experimental group showed improved inflammation, quality of life and radiological symptoms. Bone erosion remained unchanged in the experimental group, while worsening in control group. Correlation coefficients between RA duration and DAS28-ESR score were 0.496, 0.464, 0.509, and 0.550 at 1st, 3th, 6th, and 12th month, respectively. No differences were found in adverse events between the 2 groups.
CONCLUSIONS


Low-dose GCs combined with MTX and HCQ significantly achieves disease remission indexed by ACR20 and DAS28-ESR, and improves clinical and radiological outcomes in ERA patients at the early stage, with superiority over placebo + MTX + HCQ, without enhancing adverse reactions.",2020,"At 1st to 6th month, DAS28- ESR scores in the experimental group were significantly lower than control values (all p < .05).","['Eighty untreated ERA patients', 'early rheumatoid arthritis']","['low-dose glucocorticoids combined with methotrexate and hydroxychloroquine', 'placebo + MTX + HCQ', 'MTX and HCQ', 'low-dose oral GCs combined with methotrexate (MTX) and hydroxychloroquine (HCQ', 'trial (GCs + MTX + HCQ) and control (placebo + MTX + HCQ', 'Glucocorticoids (GCs']","['American College of Rheumatology (ACR) 20 of ACR, disease activity score (DAS', 'side effects (eg, gastrointestinal reactions, liver dysfunction, upper respiratory tract infection, leukocyte reduction', 'Efficacy and safety', 'inflammation, quality of life and radiological symptoms', 'disease remission', '28- erythrocyte sedimentation rate (ESR), visual analog scale scores, joint function, health assessment questionnaire-disability index score, morning stiffness duration, C-reaction protein and ESR', 'efficacy and safety', 'DAS28- ESR scores', 'Bone erosion', 'adverse events', 'RA duration and DAS28-ESR score', 'ACR20 response', 'clinical and radiological outcomes']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.115868,"At 1st to 6th month, DAS28- ESR scores in the experimental group were significantly lower than control values (all p < .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hua', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Ying', 'Affiliation': 'Department of Radiology, Jinhua Municipal Central Hospital, Jinhua Zhejiang, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Rheumatology.'}]",Medicine,['10.1097/MD.0000000000020824']
2158,32629682,Enhanced recovery after surgery (ERAS) protocols in patients undergoing radical cystectomy with ileal urinary diversions: A randomized controlled trial.,"BACKGROUND


Enhanced Recovery After Surgery (ERAS) protocols were introduced in clinical practice to reduce complication rates and hospital stay. We performed a randomized controlled single center study to evaluate perioperative benefits of an adapted ERAS protocol in patients with bladder cancer who underwent radical cystectomy (RC) and ileal urinary diversions (IUD).
MATERIALS AND METHODS


Forty five from 90 consecutive randomized patients were enrolled in an adapted ERAS protocol. Length of stay, diet issues, return of bowel function, readmission rates and complications were examined.
RESULTS


Among patients following ERAS protocol, we found a significant reduction in time to first flatus (1 vs 5 days, P < .001), time to first stool (2 vs 5 days, P < .001), time to normal diet (5 vs 6 days, P < .001) and length of stay (16 vs 18 days, P < .001). Also, postoperative ileus at less than 4 days was lower than in non-ERAS patients (15.6% vs 24.4%), but with a marginal trend toward significance (P = .05). Readmission rate was lower in the ERAS group, but the difference did not reach statistical significance. We also found a lower readmission and complication rate in patients with ERAS protocol (6.6% vs 11.1%, P = .23 and 46.6% vs 57.5%, P = .29, respectively).
CONCLUSIONS


Implementation of ERAS protocol for patients undergoing RC in our center was associated with a significant reduction in the time to the first flatus, time to the first stool, time to a normal diet, length of hospital stay.",2020,"Readmission rate was lower in the ERAS group, but the difference did not reach statistical significance.","['Forty five from 90 consecutive randomized patients were enrolled in an adapted ERAS protocol', 'patients undergoing radical cystectomy with ileal urinary diversions', 'patients with bladder cancer who underwent radical cystectomy (RC) and ileal urinary diversions (IUD']","['surgery (ERAS) protocols', 'adapted ERAS protocol']","['time to first flatus', 'time to first stool', 'lower readmission and complication rate', 'postoperative ileus', 'length of stay', 'Readmission rate', 'Length of stay, diet issues, return of bowel function, readmission rates and complications', 'time to normal diet', 'complication rates and hospital stay']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",90.0,0.0619973,"Readmission rate was lower in the ERAS group, but the difference did not reach statistical significance.","[{'ForeName': 'Olaru', 'Initials': 'O', 'LastName': 'Vlad', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Baston', 'Initials': 'B', 'LastName': 'Catalin', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Harza', 'Initials': 'H', 'LastName': 'Mihai', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Preda', 'Initials': 'P', 'LastName': 'Adrian', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Olaru', 'Initials': 'O', 'LastName': 'Manuela', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gener', 'Affiliation': 'University of Medicine and Pharmacy ""Carol Davila"" Bucharest.'}, {'ForeName': 'Sinescu', 'Initials': 'S', 'LastName': 'Ioanel', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}]",Medicine,['10.1097/MD.0000000000020902']
2159,32629685,The efficacy of acupuncture for the treatment and the fertility improvement in child-bearing period female with Hashimoto Disease: A randomized controlled study.,"BACKGROUND


Hashimoto thyroiditis (HT) is highly prevalent among reproductive-aged women and has a substantial negative impact on fertility. Currently, there is no specific treatment for Hashimoto thyroiditis. We hypothesize that acupuncture can halt or delay the progression of HT and improve fertility in child-bearing period female. We therefore designed a randomized controlled trial to test this hypothesis by comparing the therapeutic effect of acupuncture vs sham acupuncture in patients with Hashimoto thyroiditis.
METHODS


In this randomized controlled study, a total of 284 eligible patients will be assigned to acupuncture group (n = 142) or sham acupuncture group (n = 142) in a 1:1 ratio. All patients will receive 36 sessions in total for 12 consecutive weeks with the same acupoint prescription (RN23, ST9, RN17, RN4, RN6, ST36, SP6, KI6). The primary assessment is the titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb). Secondary outcomes include the thyroid function, ovarian function, the rate of primary ovarian insufficiency, and pregnancy outcome. The thyroid function and thyroid antibodies tests will be measured at weeks 0, 4, 8, and 12 after randomization. The ovarian function will be examined on the 2nd to 4th day of the menstrual period in the 1st month, 2nd month and 3rd month compared with baseline. Both the pregnancy outcome and the rate of primary ovarian insufficiency will be evaluated 1 year after treatment.
DISCUSSION


This will be the first large-scale trial specifically evaluating acupuncture therapy in child-bearing period female with Hashimoto thyroiditis. If the study confirms the effectiveness of acupuncture treatment, more consistent acupuncture therapy can be set up for clinical practice.
TRIAL REGISTRATION


Chinese Clinical Trials Register identifier, ChiCTR2000031320, registered on 27 March 2020.",2020,The primary assessment is the titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb).,"['reproductive-aged women', 'child-bearing period female with Hashimoto thyroiditis', 'patients with Hashimoto thyroiditis', 'child-bearing period female with Hashimoto Disease', '284 eligible patients', 'group (n\u200a=\u200a142) or']","['acupuncture', 'acupuncture vs sham acupuncture', 'Hashimoto thyroiditis (HT', 'acupuncture therapy', 'sham acupuncture']","['fertility improvement', 'thyroid function, ovarian function, the rate of primary ovarian insufficiency, and pregnancy outcome', 'thyroid function and thyroid antibodies tests', 'rate of primary ovarian insufficiency', 'titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb', 'ovarian function']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0700384', 'cui_str': 'Thyroid antibody'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0076635', 'cui_str': 'Thyroid microsomal antibody'}, {'cui': 'C0201512', 'cui_str': 'Thyroglobulin antibody measurement'}]",284.0,0.195251,The primary assessment is the titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb).,"[{'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hua', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Ling', 'Affiliation': 'Maternal and Child Reproductive Hospital affiliated to Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Du', 'Initials': 'D', 'LastName': 'Juan', 'Affiliation': 'Maternal and Child Reproductive Hospital affiliated to Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, PR China.'}]",Medicine,['10.1097/MD.0000000000020909']
2160,32645158,Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial.,"BACKGROUND


People with human immunodeficiency virus (PWH) face increased risks for heart failure and adverse heart failure outcomes. Myocardial steatosis predisposes to diastolic dysfunction, a heart failure precursor. We aimed to characterize myocardial steatosis and associated potential risk factors among a subset of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) participants.
METHODS


Eighty-two PWH without known heart failure successfully underwent cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content (a continuous marker for myocardial steatosis extent). Logistic regression models were applied to investigate associations between select clinical characteristics and odds of increased or markedly increased IMTG content.
RESULTS


Median (Q1, Q3) IMTG content was 0.59% (0.28%, 1.15%). IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants. Parameters associated with increased IMTG content included age (P = .013), body mass index (BMI) ≥ 25 kg/m2 (P = .055), history of intravenous drug use (IVDU) (P = .033), and nadir CD4 count < 350 cells/mm³ (P = .055). Age and BMI ≥ 25 kg/m2 were additionally associated with increased odds of markedly increased IMTG content (P = .049 and P = .046, respectively).
CONCLUSIONS


A substantial proportion of antiretroviral therapy-treated PWH exhibited myocardial steatosis. Age, BMI ≥ 25 kg/m2, low nadir CD4 count, and history of IVDU emerged as possible risk factors for myocardial steatosis in this group.
CLINICAL TRIALS REGISTRATION


NCT02344290; NCT03238755.",2020,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"['Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial', '25 kg/m2 ', 'HIV (REPRIEVE) participants', 'People with human immunodeficiency virus (PWH', 'Eighty-two PWH without known heart failure successfully underwent']","['cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content', 'Antiretroviral Therapy']","['Median (Q1, Q3', 'Age and BMI ≥', 'myocardial steatosis', 'body mass index (BMI) ≥', 'Myocardial Steatosis', 'IMTG content', 'nadir CD4 count', 'history of intravenous drug use (IVDU']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0242566', 'cui_str': 'Intravenous drug user'}]",,0.0838812,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"[{'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kim-Lien', 'Initials': 'KL', 'LastName': 'Nguyen', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Vlad G', 'Initials': 'VG', 'LastName': 'Zaha', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Advanced Imaging Research Center, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Kara W', 'Initials': 'KW', 'LastName': 'Chew', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Leavitt', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Ntobeko A B', 'Initials': 'NAB', 'LastName': 'Ntusi', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Toribio', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Magid', 'Initials': 'M', 'LastName': 'Awadalla', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Zsofia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Nelson', 'Affiliation': 'Applied Physiology and Advanced Imaging Laboratory, Department of Kinesiology, University of Texas at Arlington, Arlington, Texas, USA.'}, {'ForeName': 'Tricia H', 'Initials': 'TH', 'LastName': 'Burdo', 'Affiliation': 'Department of Neuroscience, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Clinical Research Unit, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Skiest', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Tashima', 'Affiliation': 'Division of Infectious Diseases, The Miriam Hospital and Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'Center for Clinical AIDS Research and Education, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Daar', 'Affiliation': 'Lundquist Institute at Harbor-University of California, Los Angeles Medical Center and David Geffen School of Medicine at the University of Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Alysse G', 'Initials': 'AG', 'LastName': 'Wurcel', 'Affiliation': 'Division of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Bolan', 'Affiliation': 'Los Angeles Lesbian Gay Bisexual Transgender Center, Los Angeles, California, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Duke Clinical Research Institute, Duke Global Health Institute, Department of Medicine, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'Division of Pulmonology and Department of Medicine, University of Cape Town Lung Institute, Mowbray, Cape Town, South Africa.'}, {'ForeName': 'Matthew Bidwell', 'Initials': 'MB', 'LastName': 'Goetz', 'Affiliation': 'Infectious Diseases Section, Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System and David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Alberta', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Lidia S', 'Initials': 'LS', 'LastName': 'Szczepaniak', 'Affiliation': 'Biomedical Research Consulting in Magnetic Resonance Spectroscopy, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa245']
2161,32645161,Leveraging a Landmark Trial of Primary Cardiovascular Disease Prevention in Human Immunodeficiency Virus: Introduction From the REPRIEVE Coprincipal Investigators.,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus. Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents, REPRIEVE will assess the effects of a statin as a cardiovascular disease prevention strategy in people with HIV (PWH) receiving antiretroviral therapy (ART). Although the primary purpose of REPRIEVE, and its substudy assessing coronary plaque, is to assess cardiovascular outcomes, the trial is a rich source of data on population characteristics and critical comorbidities in PWH, particularly across Global Burden of Disease (GBD) regions, reflective of the ethnic, racial, and gender diversity in this global epidemic. The purpose of this Supplement is to leverage the rich phenotyping in REPRIEVE, to provide data on detailed patterns of baseline ART and immune function by GBD region, reproductive aging among cisgender women, and data on the participation and clinical characteristics of transgender participants. We also leveraged REPRIEVE to assess critical comorbidities, including renal dysfunction, muscle function and frailty, and myocardial steatosis. REPRIEVE is a remarkable collaboration between funders, trial networks, clinical research sites, clinical and data coordinating centers, and willing participants who devoted their time to make the trial possible.",2020,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"['Human Immunodeficiency Virus', 'human immunodeficiency virus', 'Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents', 'people with HIV (PWH) receiving antiretroviral therapy (ART']",[],"['renal dysfunction, muscle function and frailty, and myocardial steatosis']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],"[{'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",7770.0,0.113634,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Center, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa098']
2162,32645640,The ocrelizumab phase II extension trial suggests the potential to improve the risk: Benefit balance in multiple sclerosis.,"OBJECTIVE


Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval.
METHODS


Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54-55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0-72), followed by an 18 month treatment-free period.
RESULTS


CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events.
CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust.",2020,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles",[],"['placebo or interferon-beta to ocrelizumab', 'cladribine and alemtuzumab', 'Ocrelizumab', 'ocrelizumab']","['annualized relapse rate', 'new T1 gadolinium-enhancing or T2 lesions']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.0255681,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom. Electronic address: david.baker@qmul.ac.uk.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Pryce', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Louisa K', 'Initials': 'LK', 'LastName': 'James', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Marta', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmierer', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102279']
2163,32645683,Eye tracking of smoking-related stimuli in tobacco use disorder: A proof-of-concept study combining attention bias modification with alpha-transcranial alternating current stimulation.,"BACKGROUND


Tobacco use disorder (TUD) is characterized by the presence of an attentional bias (AB) towards smoking-related stimuli. We investigated whether combining an AB modification paradigm (ABM) with transcranial alternating current stimulation (tACS) applied over the dorsolateral prefrontal cortex (DLPFC) reduces the AB towards smoking-related stimuli, as well as craving level and impulsive choices.
METHODS


In a sham-controlled, crossover preliminary study, 19 subjects with TUD received two stimulation arms: 1) active tACS (10 Hz, 2 mA, 30 min) combined with ABM and 2) sham tACS combined with ABM, in a randomized order, separated by one week. AB towards smoking cues during passive observation of smoking and neutral cues was assessed with an eye-tracking device and reactions times at a visual-probe task. Craving level was measured with the Questionnaire of Smoking Urges. Impulsive choices were assessed with the delay discounting task.
RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM. No significant effects were reported on other craving dimensions and on AB based on reaction times.
CONCLUSIONS


These preliminary findings suggest that combining tACS with ABM may help smokers who wish to quit by reducing the desire to smoke, attention to smoking-cues, and impulsive decision-making.",2020,"RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM.","['19 subjects with TUD received two stimulation arms: 1', 'tobacco use disorder']","['tACS with ABM', 'alpha-transcranial alternating current stimulation', 'active tACS (10 Hz, 2 mA, 30 min) combined with ABM and 2) sham tACS combined with ABM', 'AB modification paradigm (ABM) with transcranial alternating current stimulation (tACS']","['Impulsive choices', 'increase of self-reported desire to smoke', 'delay discounting task', 'proportion of impulsive choices', 'craving dimensions and on AB based on reaction times', 'Craving level', 'time spent looking at smoking-related pictures']","[{'cui': 'C0040336', 'cui_str': 'Tobacco abuse'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",19.0,0.0484381,"RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Mondino', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lenglos', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cinti', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Renauld', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Fecteau', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada. Electronic address: shirley.fecteau@fmed.ulaval.ca.""}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108152']
2164,32646502,Outpatient treatment of COVID-19 with steroids in the phase of mild pneumonia without the need for admission as an opportunity to modify the course of the disease: A structured summary of a randomised controlled trial.,"OBJECTIVES


The aim of this study is to explore the effectiveness and safety of oral corticosteroids (prednisone) in the treatment of early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission criteria.
TRIAL DESIGN


Randomized clinical trial, controlled, open, parallel group, to evaluate the effectiveness of steroids in adult patients with confirmed COVID-19, with incipient pulmonary involvement, without hospital admission criteria. Patients will be stratified by the presence or not of radiological data on pneumonia.
PARTICIPANTS


We will include patients with early stage SARS-Cov-2 pneumonia who do not meet hospital admission criteria from the reference hospital, the Hospital Universitario de Burgos, in the region of Castilla y León, Spain. Patients will be followed-up by specialist physicians and Primary Health Care professionals.
INCLUSION CRITERIA


- Men and women. - Age between 18 and 75 years old. - Diagnosed SARS-CoV-2 infection, by PCR and/or IgM+ antibody test and/or antigen test. - Clinical diagnosis of lung involvement: (respiratory symptoms +/- pathological auscultation +/- O2 desaturation) - Chest X-ray with mild-moderate alterations or normal. - Patients who give their verbal informed consent in front of witnesses, which will be reflected in the patients' medical records.
EXCLUSION CRITERIA


- Oxygen desaturation below 93% or P0 2  < 62. - Moderate-severe dyspnea or significant respiratory or general deterioration that makes admission advisable. - Chest X-ray with multifocal infiltrates. - Insulin-dependent diabetes with poor control or glycaemia in the emergency room test greater than 300 mg/ml (fasting or not). - Other significant comorbidities: Severe renal failure (creatinine clearance < 30 mL/min); cirrhosis or chronic liver disease, poorly controlled hypertension. - Heart rhythm disturbances (including prolonged QT). - Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents); cancer. - Pregnant or breast-feeding women. - Patients under use of glucocorticoids for other diseases. - History of allergy or intolerance to any of the drugs in the study (prednisone, azithromycin or hydroxychloroquine). - Patients who took one or more of the study drugs in the 7 days prior to study inclusion. - Patients taking non-suppressible drugs with risk of QT prolongation or significant interactions. - Patients unwilling or unable to participate until study completion. - Participation in another study.
INTERVENTION AND COMPARATOR


Eligible patients will be randomized to receive standard outpatient treatment only (group 1) or standard outpatient treatment plus prednisone (group 2). - Group 1: paracetamol 1 g/8 h (on demand) + hydroxychloroquine 400 mg/12h the first day, 200 mg/12 h for 4 days + azithromycin 500 mg/24h for 5 days. - Group 2: paracetamol 1 g/8 h (on demand) + hydroxychloroquine 400 mg/12h the first day, 200 mg/12 h for 4 days + azithromycin 500 mg/24h for 5 days + prednisone 60 mg / 24 h for 3 days, 30 mg / 24 h for 3 days and 15 mg / 24 h for 3 days.
MAIN OUTCOMES


If the patient requires ambulatory observation, according to the protocol established in this respect in the Emergency Department, meets all the criteria for inclusion and none for exclusion, data will be taken by the person responsible on the data collection sheet. The main result is admission after 30 days. Secondary outcomes are 30-day ICU admission and hospital stay. The safety variable will be the occurrence of clinical symptoms or delirium related to the steroids. Also, the possible decompensations of diabetes will be measured. All tests will be on an intention-to-treat basis.
RANDOMISATION


Treatment will be assigned according to stratified randomization by the presence or absence of radiological data of lung involvement (previously performed by random sequence 1:1 generated with Epidat and kept hidden by opaque, sealed envelopes, which will only be opened after inclusion and basal measurement).
BLINDING (MASKING)


Participants, caregivers and personnel responsible for outcomes measurement will not be blinded to group assignment, once the patient is included and the basal measurement performed, as per protocol design.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The percentage of patients with incipient lung involvement is unknown, but given that pulmonary involvement already exists it is estimated to be around 20%. We consider that the intervention could reduce this percentage to 5%, so the necessary sample size would be 200 subjects (100 per group), with a power of 80% and an estimated loss percentage of 10%.
TRIAL STATUS


The protocol with code TAC-COVID-19, version 2.0 on date: April 16, 2020 is approved by the Spanish Drug Agency (AEMPS) and the local Ethics Committee. The trial is in the recruitment phase. Recruitment began 19 April, 2020 and is anticipated to be complete by April 2021.
TRIAL REGISTRATION


The trial was registered under the title ""OUTPATIENT TREATMENT OF EARLY PULMONARY COVID19 WITH CORTICOSTEROIDS AS AN OPPORTUNITY TO MODIFY THE COURSE OF THE DISEASE"" with EudraCT number 2020-001622-64 , registered on 3 April 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The protocol with code TAC-COVID-19, version 2.0 on date: April 16, 2020 is approved by the Spanish Drug Agency (AEMPS) and the local Ethics Committee.","[' with EudraCT number 2020-001622-64 , registered on 3 April 2020', 'adult patients with confirmed COVID-19, with incipient pulmonary involvement, without hospital admission criteria', ' Pregnant or breast-feeding women', 'early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission criteria', ' Age between 18 and 75 years old', ' Men and women', ' Patients who took one or more of the study drugs in the 7 days prior to study inclusion', ' 30 mL/min); cirrhosis or chronic liver disease, poorly controlled hypertension', 'patients with early stage SARS-Cov-2 pneumonia who do not meet hospital admission criteria from the reference hospital, the Hospital Universitario de Burgos, in the region of Castilla y León, Spain', 'Patients will be followed-up by specialist physicians and Primary Health Care professionals', ' Patients unwilling or unable to participate until study completion']","['azithromycin 500 mg/24h for 5 days + prednisone', 'standard outpatient treatment only (group 1) or standard outpatient treatment plus prednisone', 'paracetamol 1 g/8 h (on demand) + hydroxychloroquine', 'prednisone, azithromycin or hydroxychloroquine', 'COVID-19 with steroids', 'steroids', 'glucocorticoids', 'oral corticosteroids (prednisone', 'azithromycin']","[' Heart rhythm disturbances', '30-day ICU admission and hospital stay', 'renal failure (creatinine clearance', 'pathological auscultation ']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205256', 'cui_str': 'Incipient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]",,0.132014,"The protocol with code TAC-COVID-19, version 2.0 on date: April 16, 2020 is approved by the Spanish Drug Agency (AEMPS) and the local Ethics Committee.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Saiz-Rodríguez', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Peña', 'Affiliation': 'Neumology Department, Hospital Universitario de Burgos, Avda Islas Baleares, 3, Burgos, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Lázaro', 'Affiliation': 'Neumology Department, Hospital Universitario de Burgos, Avda Islas Baleares, 3, Burgos, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'González', 'Affiliation': 'Gerencia de Atención Primaria de Burgos, Burgos, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Martínez', 'Affiliation': 'Gerencia de Atención Primaria de Burgos, Burgos, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Cordero', 'Affiliation': 'Instituto de Investigación Sanitaria Bioaraba, Vitoria-Gasteiz, Álava, Spain.'}, {'ForeName': 'Juan T', 'Initials': 'JT', 'LastName': 'Vicente', 'Affiliation': 'Emergency Department, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Emergency Department, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Coma', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'de Frutos', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Labrador', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pueyo', 'Affiliation': 'Neumology Department, Hospital Universitario de Burgos, Avda Islas Baleares, 3, Burgos, Spain. pueyo@saludcastillayleon.es.'}]",Trials,['10.1186/s13063-020-04575-w']
2165,32646559,"Re. Guber et al: How to Prevent Retinal Shift after Rhegmatogenous Retinal Detachment Repair: A Prospective, Randomized Study.",,2020,,['after Rhegmatogenous Retinal Detachment Repair'],['Retinal Shift'],[],"[{'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",[],,0.0234217,,"[{'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Casswell', 'Affiliation': 'Vitreoretinal Department, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Charteris', 'Affiliation': 'Vitreoretinal Department, Moorfields Eye Hospital, London, United Kingdom.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.01.020']
2166,32646850,Prostate Imaging Quality (PI-QUAL): A New Quality Control Scoring System for Multiparametric Magnetic Resonance Imaging of the Prostate from the PRECISION trial.,"The PRECISION trial was a multicentre randomised study that demonstrated that multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy is superior to standard transrectal ultrasound-guided biopsy for the detection of prostate cancer. The outcomes of studies reporting mpMRI-targeted biopsies are dependent on the quality of the mpMRI but there are currently no scoring systems available for evaluating this. We introduced a novel scoring system, the Prostate Imaging Quality (PI-QUAL) score, to assess the quality of scans in the PRECISION trial. PI-QUAL is a score on a Likert scale from 1 to 5, where 1 means that no mpMRI sequences are of diagnostic quality and 5 implies that each sequence is independently of optimal diagnostic quality. Fifty-eight out of 252 (23%) mpMRI scans chosen at random from each of the 22 centres in this trial were evaluated by two experienced radiologists from the coordinating trial centre, in consensus, blinded to pathology results. Overall, the mpMRI quality in the centres participating in PRECISION was good. MpMRI quality was of sufficient diagnostic quality (PI-QUAL ≥3) for 55 scans (95%) and of good or optimal diagnostic quality (PI-QUAL ≥4) for 35 scans (60%). Fifty-five out of 58 (95%) scans were of diagnostic quality for T2WI, followed by DWI (46/58 scans; 79%), and DCE (38/58 scans; 66%). Further validation of this scoring system is warranted. PATIENT SUMMARY: In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection. We used scans from 22 centres that participated in the PRECISION trial. Although there was room for improvement in images that used intravenous contrast, we found that mpMRI in the PRECISION trial was of sufficient diagnostic quality (PI-QUAL score ≥3) for 95% of the scans.",2020,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"['prostate cancer detection', 'Fifty-eight out of 252 (23']","['multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy', 'standard transrectal ultrasound-guided biopsy', 'Prostate Imaging Quality (PI-QUAL', 'multiparametric magnetic resonance imaging (mpMRI']","['diagnostic quality', 'MpMRI quality', 'mpMRI quality', 'Prostate Imaging Quality (PI-QUAL) score']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.0461845,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giganti', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK; Division of Surgery & Interventional Science, University College London, London, UK. Electronic address: f.giganti@ucl.ac.uk.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Moore', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Veeru', 'Initials': 'V', 'LastName': 'Kasivisvanathan', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology oncology,['10.1016/j.euo.2020.06.007']
2167,32647023,Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol.,"INTRODUCTION


Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has  never  been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has automated data collection for surgical patients. Similarly, the 'REthinking Clinical Trials' (REaCT) platform increases RCT enrolment by simplifying pragmatic trial design. In this novel RCT protocol, we combine REaCT and NSQIP to compare OA alone versus no preparation for SSI rate reduction in elective colon surgery. To our knowledge, this is the first published RCT protocol that leverages NSQIP for data collection. In our feasibility study, 67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol. The 'REaCT-NSQIP' trial design has great potential to efficiently generate level I evidence for other perioperative interventions.
METHODS AND ANALYSIS


SSI rates following elective colorectal surgery after preoperative OA or no preparation will be compared. We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications. Consent, using the 'integrated consent model', and randomisation on a mobile device are completed by the surgeon in a single clinical encounter. Data collection for the primary end point is automatic through NSQIP. Analysis of cost per weighted case, cost utility and quality-adjusted life years will be done.
ETHICS AND DISSEMINATION


This study is approved by The Ontario Cancer Research Ethics Board. Results will be disseminated in surgical conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03663504; Pre-results, recruitment phase.",2020,"We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications.","['67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol', 'surgical patients', 'elective colon surgery']","['elective colorectal surgery after preoperative OA or no preparation', 'preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP', 'REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone', 'National Surgical Quality Improvement Program (NSQIP']","['length of stay, reduced costs and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.153862,"We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications.","[{'ForeName': 'Sameer S', 'Initials': 'SS', 'LastName': 'Apte', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Husein', 'Initials': 'H', 'LastName': 'Moloo', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ahwon', 'Initials': 'A', 'LastName': 'Jeong', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandemeer', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Suh', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Auer', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada rauer@ohri.ca.'}]",BMJ open,['10.1136/bmjopen-2020-036866']
2168,32627205,"Blood Donor Recruitment in Guangzhou, China, during the 2019 Novel Coronavirus (COVID-19) Epidemic.","BACKGROUND


The coronavirus disease 2019 (COVID-19) epidemic affected blood collection in Guangzhou, China.
STUDY DESIGN AND METHODS


This paper included three studies. The observational study reported the trends of blood collection during the epidemic in Guangzhou, China. The cross-sectional survey investigated factors influencing blood donation during the COVID-19 epidemic, and a self-administered questionnaire was given to 1,584 street whole blood donors (SWBDs) who donated during the epidemic. The randomized controlled trial involved 19,491 SWBDs who donated in 2019 but did not donate during the epidemic. Trial participants were randomly assigned to two intervention groups: group 1 completed Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; and group 2 completed Questionnaire 2, which did not include this information. A control group did not receive any questionnaire.
RESULTS


As measures implemented, the number of blood donors increased accordingly. Both first-time and repeat SWBDs perceived the same level of blood need and donated blood because it would save lives. SWBDs who completed Questionnaire 1 expressed a greater intention to donate during the epidemic. Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks. Intention-to-treat analyses and average-treatment-effect-on-the-treated estimations confirmed that Questionnaire 1 could motivate SWBDs to actually donate blood.
CONCLUSION


Various measures could ease blood shortage during the COVID-19 epidemic. Administration of Questionnaire 1 could increase blood donations during the epidemic. This article is protected by copyright. All rights reserved.",2020,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"['19,491 SWBDs who donated in 2019 but did not donate during the epidemic']","['Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; and group 2 completed Questionnaire 2, which did not include this information']","['blood donations', 'number of blood donors', 'blood shortage']","[{'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0375876', 'cui_str': 'Whole blood donor'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",19491.0,0.0277604,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ou-Yang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shi-Jie', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chun-Hua', 'Initials': 'CH', 'LastName': 'Bei', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jin-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hua-Qin', 'Initials': 'HQ', 'LastName': 'Liang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yong-Shui', 'Initials': 'YS', 'LastName': 'Fu', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}]",Transfusion,['10.1111/trf.15971']
2169,32627438,Effects of Repetitive Transcranial Magnetic Stimulation on Improvement of Mental Health and Clinical Parameters in Depressed Hemodialysis Patients: a Pilot Study.,"BACKGROUND


This study aimed to evaluate the therapeutic effect of repetitive transcranial magnetic stimulation (rTMS) as a nonpharmacologic treatment in depressed hemodialysis patients.
METHODS


Patients who scored ≥ 5 on the Patient Health Questionnaire-9 were randomized to either the rTMS (n = 7) or sham group (n = 7). The rTMS group was stimulated with a 110% motor threshold and 10 Hz on the left dorsolateral prefrontal cortex for 20 minutes, three times a week, for 4 weeks. In the sham group, the ""1-wing 90-degree method"" was used. We analyzed clinical indices before and after the intervention, as well as data from quantitative electroencephalography (frontal alpha asymmetry [FAA]), and various psychiatric questionnaires (Beck Depression Inventory-II, Beck Anxiety Inventory [BAI], Symptom Checklist-90-Revised Somatization Subscale [SCL-90R-SOM]), and Perceived Stress Scale.
RESULTS


One month after rTMS, the changes in hemoglobin A1c levels in the rTMS group were significantly greater than those in the sham group ( F  = 6.687,  P  = 0.032). The changes in BAI scores in the rTMS group were significantly greater than those in the sham group ( F  = 6.700,  P  = 0.025), and the changes in SCL-90R-SOM scores in the rTMS group were greater than those in the sham group ( F  = 4.943,  P  = 0.048). In addition, the changes in the FAA value at the F7 and F8 electrodes in the rTMS group were greater than those in the sham group ( F  = 6.468,  P  = 0.027).
CONCLUSION


In depressed hemodialysis patients, rTMS may improve anxiety and somatization symptoms, which may lead to improvements in clinical measures. Trial Registration Clinical Research Information Service Identifier: KCT0004082.",2020,"The changes in BAI scores in the rTMS group were significantly greater than those in the sham group ( F  = 6.700,  P  = 0.025), and the changes in SCL-90R-SOM scores in the rTMS group were greater than those in the sham group ( F  = 4.943,  P  = 0.048).","['depressed hemodialysis patients', 'Patients who scored ≥ 5 on the Patient Health Questionnaire-9', 'Depressed Hemodialysis Patients']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['SCL-90R-SOM scores', 'FAA value at the F7 and F8 electrodes', 'anxiety and somatization symptoms', 'BAI scores', 'quantitative electroencephalography (frontal alpha asymmetry [FAA]), and various psychiatric questionnaires (Beck Depression Inventory-II, Beck Anxiety Inventory [BAI], Symptom Checklist-90-Revised Somatization Subscale [SCL-90R-SOM]), and Perceived Stress Scale', 'Mental Health and Clinical Parameters', 'hemoglobin A1c levels']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0037640', 'cui_str': 'Somalia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}]",,0.0172177,"The changes in BAI scores in the rTMS group were significantly greater than those in the sham group ( F  = 6.700,  P  = 0.025), and the changes in SCL-90R-SOM scores in the rTMS group were greater than those in the sham group ( F  = 4.943,  P  = 0.048).","[{'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Hyunchan', 'Initials': 'H', 'LastName': 'Hwang', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Hye Ri', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Doug Hyun', 'Initials': 'DH', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea. sunmikim706@gmail.com.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e205']
2170,32623230,"Supplemental income program design: A cluster-randomized controlled trial to examine the health and wellbeing effects on older adults by gender, duration, and payment frequency.","BACKGROUND


We documented results from a cluster-randomized controlled trial we designed to supplement incomes in poor towns among adults 70 or older. We analyzed effects on health by gender, persistence over time, and variation by payment frequency.
METHODS


We compared supplemental income effects over an 18-month period for two towns in Yucatan, Mexico: Valladolid, where eligible individuals received a monthly income supplement over the entire analysis period, and Motul, a demographically matched control town, where eligible individuals received a bimonthly income supplement over the last 12 months of the analysis period. While differing in frequency of payment, supplements provided similar levels of income. We conducted three surveys of recipients: (1) at baseline, (2) six months after baseline, and (3) 18 months after baseline.
RESULTS


The primary outcomes we examined were peak expiratory flow, hemoglobin level, and verbal recall. The secondary outcomes were health care use and food availability. We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting. Bimonthly income supplements had smaller health benefits.
CONCLUSIONS


Older people in the developing world who lack social security benefits and health care may benefit most from monthly income programs. The greater payment frequency of monthly programs may influence how household resources are allocated. Supplemental income programs are common in low- and middle-income countries; hence, our results have implications for program design in many nations.",2020,"We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting.","['supplement incomes in poor towns among adults 70 or older', 'older adults by gender, duration, and payment frequency']",[],"['health care use and food availability', 'peak expiratory flow, hemoglobin level, and verbal recall', 'smaller health benefits']","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}]",,0.190785,"We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Aguila', 'Affiliation': 'Sol Price School of Public Policy, USC, 650 Childs Way, RGL Hall, Room 226, Los Angeles, CA, 90089, USA. Electronic address: eaguilav@usc.edu.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Smith', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113139']
2171,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
2172,32623361,Immediate effects of valgus bracing on knee joint moments during walking in knee-healthy individuals: Potential modifying effects of body height.,"BACKGROUND


The goal of valgus knee brace treatment is to reduce medial knee joint loading during walking, often indicated by external knee adduction moment (KAM) measures. However, existing healthy-subjects studies have been equivocal in demonstrating KAM reduction with valgus knee bracing.
RESEARCH QUESTION


What are the immediate effects of valgus bracing at different tension levels on KAM during walking at a controlled speed and does body height modify the brace-KAM associations?
METHODS


Data from 32 knee-healthy participants were analysed in this randomized crossover trial. Participants performed walking trials at controlled speed (1.3 ± 0.065 m/s) both with and without an Ossür Unloader One® brace. During the bracing condition, valgus tension was incrementally increased, from zero tension to normal tension and to maximum tolerable tension.
RESULTS


Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels. Valgus bracing, overall, did not significantly reduce the various KAM measures. However, brace use at maximal tension was associated with a 0.04Nm/kg (9.2 %) increase in first peak KAM amongst participants with a body height of 1.75 m and a 0.03Nm/kg (7.6 %) decrease in first peak KAM amongst participants with a body height of 1.55 m.
SIGNIFICANCE


Valgus bracing did not reduce the various KAM measures during walking; however, body height may play a moderating role. Given knee brace sizes vary more in circumference than length, this result may be due to the ratio between effective moment arm length relative to limb length. A deeper understanding of the potential neuro-biomechanical effects of valgus knee bracing and how these effects are potentially modified by body height may be critical to the design of effective knee braces.",2020,Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels.,"['Data from 32 knee-healthy participants', 'knee-healthy individuals']",['valgus bracing'],"['gait velocity', 'various KAM measures', 'knee joint moments', 'knee flexion at heel-strike']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]",,0.0313931,Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels.,"[{'ForeName': 'Yong-Hao', 'Initials': 'YH', 'LastName': 'Pua', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: pua.yong.hao@sgh.com.sg.'}, {'ForeName': 'Hong-Han', 'Initials': 'HH', 'LastName': 'Tan', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: tan.hong.han@sgh.com.sg.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Mentiplay', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Victoria, Australia. Electronic address: b.mentiplay@latrobe.edu.au.'}, {'ForeName': 'Leon Zhi-Xia', 'Initials': 'LZ', 'LastName': 'Lim', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: leonlimzx@hotmail.com.'}, {'ForeName': 'Asher Chi-Weng', 'Initials': 'AC', 'LastName': 'Tham', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: ashertham@hotmail.com.'}, {'ForeName': 'Joshua Jia-En', 'Initials': 'JJ', 'LastName': 'Quek', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: Quek.joshua@gmail.com.'}, {'ForeName': 'Ee-Lin', 'Initials': 'EL', 'LastName': 'Woon', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: woon.ee.lin@sgh.com.sg.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Yeh', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: tingting.yeh@singaporetech.edu.sg.'}, {'ForeName': 'Celia Ia-Choo', 'Initials': 'CI', 'LastName': 'Tan', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore; SingHealth Group Allied Health, Singapore. Electronic address: celia.tan.i.c@singhealth.com.sg.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Hunt', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada. Electronic address: michael.hunt@ubc.ca.'}, {'ForeName': 'Ross Allan', 'Initials': 'RA', 'LastName': 'Clark', 'Affiliation': 'Research Health Institute, University of the Sunshine Coast, Sunshine Coast, Australia. Electronic address: rclark@usc.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.06.025']
2173,32629091,Early-onset pneumonia following bag-mask ventilation versus endotracheal intubation during cardiopulmonary resuscitation: A substudy of the CAAM trial.,"AIM


Early-onset pneumonia (EOP) is a common in-hospital complication in survivors of out-of-hospital cardiac arrest. In this substudy of the CAAM trial, we aimed to compare whether bag mask ventilation (BMV) compared to endotracheal intubation (ETI) performed during cardiopulmonary resuscitation increases the risk of developing EOP.
METHODS


Adult patients from the CAAM trial that survived beyond 12 h of hospitalization were included. Information about in-hospital management and outcome of study subjects was systematically collected. Our primary aim was to compare the incidence of EOP in the BMV and ETI group using a series of bivariate analysis adjusting for one variable at a time and a logistic regression controlled for survival beyond 96 h, age, gender, catecholamine administration, no flow time, and initial shockable rhythm.
RESULTS


Of 627 patients from the CAAM trial that survived to hospital admission, 409 patients were hospitalized beyond 12 h and thus included (202 randomized to BMV and 20 7 randomized to ETI). Patients in the BMV group had a significantly longer period of unsecured airway during prehospital cardiopulmonary resuscitation (BMV (median): 33 min; ETI (median): 17 min, p < 0.0001). No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7-1.5], p = 1.0). We found no difference in the development of EOP according to airway management in the series of bivariate analyses or in the multivariable regression analysis either.
CONCLUSION


In this substudy of the CAAM trial, development of early-onset pneumonia in out-of-hospital cardiac arrest survivors did not depend on airway management technique during CPR.",2020,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","['cardiopulmonary resuscitation', 'Adult patients from the CAAM trial that survived beyond 12\u2009hours of hospitalization were included', '627 patients from the CAAM trial that survived to hospital admission', '409 patients were hospitalized beyond 12\u2009hours and thus included (202 randomized to BMV and 20 7 randomized to ETI']","['endotracheal intubation (ETI', 'bag-mask ventilation versus endotracheal intubation', 'bag mask ventilation (BMV']","['development of EOP according to airway management', 'risk of developing EOP', 'incidence of EOP']","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",627.0,0.0603892,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","[{'ForeName': 'Josefine S', 'Initials': 'JS', 'LastName': 'Baekgaard', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark; Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France. Electronic address: josefine.stokholm.baekgaard.01@regionh.dk.'}, {'ForeName': 'Mohamed N', 'Initials': 'MN', 'LastName': 'Triba', 'Affiliation': ""Sorbonne Paris Cité, Equipe Nanomédecine Biomarqueurs Détection, Laboratoire de Chimie, Structures et Propriétés de Biomateriaux et d'Agents Therapeutiques, UMR CNRS 7244, University Paris 13 Bobigny, France.""}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Brandeis', 'Affiliation': 'Service des Urgences, Hopital Ballanger, 93600 Aulnays, France.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Cohen', 'Affiliation': 'Intensive Care Unit, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gorlicki', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Deltour', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}]",Resuscitation,['10.1016/j.resuscitation.2020.06.011']
2174,32629639,Personalized trimodal prehabilitation for gastrectomy.,"BACKGROUND


Surgery is the only potentially curative treatment for gastric cancer, however, it bears a high postoperative morbidity and mortality rate. A recent randomized control trial proposed prehabilitation to reduce the postoperative morbidity in patients undergoing major abdominal surgery. Currently, there is a lack of evidence of using prehabilitation for patients undergoing gastrectomy for gastric cancer. The aim of our study is to demonstrate that home-based prehabilitation can reduce postoperative morbidity after gastrectomy for gastric cancer.
METHODS


PREFOG is a multi-center, open-label randomized control trial comparing 90-days postoperative morbidity rate after gastrectomy for gastric cancer between patients with or without prehabilitation. One-hundred twenty-eight patients will be randomized into an intervention or control group. The intervention arm will receive trimodal home-based prehabilitation including nutritional, psychological and exercise interventions. Secondary outcomes of the study will include physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board.
DISCUSSION


PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer. Moreover, this study will allow us to determine whether prehabilitation can improve physical fitness and activity levels, nutritional status and quality of life as well as reducing anxiety and depression levels after gastrectomy for gastric cancer.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04223401 (First posted: 10 January 2020).",2020,"DISCUSSION


PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer.","['patients undergoing major abdominal surgery', 'patients undergoing gastrectomy for gastric cancer', 'gastric cancer between patients with or without prehabilitation', 'One-hundred twenty-eight patients']","['trimodal home-based prehabilitation including nutritional, psychological and exercise interventions']","['physical fitness and activity levels, nutritional status and quality of life', 'physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board', 'anxiety and depression levels', 'postoperative morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",128.0,0.0360009,"DISCUSSION


PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer.","[{'ForeName': 'Augustinas', 'Initials': 'A', 'LastName': 'Bausys', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Martynas', 'Initials': 'M', 'LastName': 'Luksta', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Justas', 'Initials': 'J', 'LastName': 'Kuliavas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Giedre', 'Initials': 'G', 'LastName': 'Anglickiene', 'Affiliation': 'Department of Medical Oncology, National Cancer Institute.'}, {'ForeName': 'Vyte', 'Initials': 'V', 'LastName': 'Maneikiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine of the Faculty of Medicine.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Gedvilaite', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine of the Faculty of Medicine.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Celutkiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine of the Faculty of Medicine.'}, {'ForeName': 'Ieva', 'Initials': 'I', 'LastName': 'Jamontaite', 'Affiliation': 'Department of Rehabilitation, Physical and Sports Medicine, Institute of Health Sciences, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Cirtautas', 'Affiliation': 'Department of Rehabilitation, Physical and Sports Medicine, Institute of Health Sciences, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Lenickiene', 'Affiliation': 'Department of Rehabilitation, Physical and Sports Medicine, Institute of Health Sciences, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Vaitkeviciute', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Edita', 'Initials': 'E', 'LastName': 'Gaveliene', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Gertruda', 'Initials': 'G', 'LastName': 'Klimaviciute', 'Affiliation': 'National Cancer Institute, Vilnius, Lithuania.'}, {'ForeName': 'Rimantas', 'Initials': 'R', 'LastName': 'Bausys', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Kestutis', 'Initials': 'K', 'LastName': 'Strupas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}]",Medicine,['10.1097/MD.0000000000020687']
2175,32629640,All-inside versus inside-out suture techniques in arthroscopic meniscus repair: A prospective randomized study protocol.,"BACKGROUND


With advancements in our understanding of meniscal function, treatment options for meniscal injuries have evolved considerably over the past few decades. The aim of the current study was to compare the all-inside and inside-out techniques with regard to retear rate, functional outcomes, and perioperative complications in patients who had undergone arthroscopic meniscus repair. We hypothesized that there was no significant difference between the 2 groups in terms of postoperative outcomes after arthroscopic meniscus repair.
METHODS


This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. This study was approved by the Institutional Review Board in our hospital and written informed consent was obtained from all subjects participating in the trial. It was carried out in accordance with the principles of the Helsinki Declaration. A total of 70 patients who meet inclusion criteria are randomized to either all-inside or inside-out group. The primary outcome measure was retear rate. Retear was determined by repeat arthroscopic evaluation of patients with follow-up for symptoms of persistent or new pain, catching, or locking that was possibly related to the meniscal repair. Secondary outcomes included disease-specific quality of life measurement with the Western Ontario Meniscal Evaluation Tool, range of motion, operative time, and adverse events at surgery or throughout the follow-up period.
RESULTS


This study has limited inclusion and exclusion criteria and a well-controlled intervention.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5589).",2020,"We hypothesized that there was no significant difference between the 2 groups in terms of postoperative outcomes after arthroscopic meniscus repair.
","['patients who had undergone arthroscopic meniscus repair', 'subjects participating in the trial', 'arthroscopic meniscus repair', '70 patients who meet inclusion criteria']",['All-inside versus inside-out suture techniques'],"['disease-specific quality of life measurement with the Western Ontario Meniscal Evaluation Tool, range of motion, operative time, and adverse events at surgery or throughout the follow-up period', 'retear rate', 'postoperative outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0407887', 'cui_str': 'Repair of meniscus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",70.0,0.0844305,"We hypothesized that there was no significant difference between the 2 groups in terms of postoperative outcomes after arthroscopic meniscus repair.
","[{'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedics, Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan 610072, China.'}, {'ForeName': 'Jiasong', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020688']
2176,32629657,Therapeutic effect of percutaneous vertebroplasty and nonoperative treatment on osteoporotic vertebral compression fracture: A randomized controlled trial protocol.,"BACKGROUND


Osteoporosis and related complications have been increasing with the aging population. Osteoporotic vertebral compression fractures (OVCFs) are the most common among all osteoporotic fractures. The purpose of this study was performed to compare the efficiency and safety of vertebroplasty versus conservative treatment for acute OVCFs.
METHODS


The conduct of this study followed the Declaration of Helsinki principles and the reporting of this study adhered to the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials. Written informed consent was obtained from every participant. Participants were randomly assigned (1:1) to receive either vertebroplasty or control group. The primary outcome was pain relief at 1 month and 1 year, measured with a Visual Analogue Scale score. The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications.
RESULTS


We hypothesize that vertebroplasty will provide a rapid decrease of pain and an early return to daily life activities compared with the control group.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5624).",2020,"The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications.
",['osteoporotic vertebral compression fracture'],"['percutaneous vertebroplasty and nonoperative treatment', 'vertebroplasty or control group', 'vertebroplasty']","['Osteoporotic vertebral compression fractures (OVCFs', 'efficiency and safety', 'pain and an early return to daily life activities', 'Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications', 'pain relief at 1 month and 1 year, measured with a Visual Analogue Scale score']","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.164349,"The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications.
","[{'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Spinal Surgery, Yancheng NO.1 People's Hospital, Jiang Su, China.""}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Cang', 'Affiliation': ''}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020770']
2177,32630549,"Development of a Tailored, Complex Intervention for Clinical Reflection and Communication about Suspected Urinary Tract Infections in Nursing Home Residents.","BACKGROUND


Inappropriate antibiotic treatments for urinary tract infections (UTIs) in nursing homes cause the development of resistant bacteria. Nonspecific symptoms and asymptomatic bacteriuria are drivers of overtreatment. Nursing home staff provide general practice with information about ailing residents; therefore, their knowledge and communication skills influence prescribing. This paper describes the development of a tailored, complex intervention for a cluster-randomised trial that targets the knowledge of UTI and communication skills in nursing home staff to reduce antibiotic prescriptions.
METHODS


A dialogue tool was drafted, drawing on participatory observations in nursing homes, interviews with stakeholders, and a survey in general practice. The tool was tailored through a five-phase process that included stakeholders. Finally, the tool and a case-based educational session were tested in a pilot study.
RESULTS


The main barriers were that complex patients were evaluated by healthcare staff with limited knowledge about disease and clinical reasoning; findings reported to general practice were insignificant and included vague descriptions; there was evidence of previous opinion bias; nonspecific symptoms were interpreted as UTI; intuitive reasoning led to the inappropriate suspicion of UTI.
CONCLUSION


Sustainable change in antibiotic-prescribing behaviour in nursing homes requires a change in nursing home staff's beliefs about and management of UTIs.",2020,Sustainable change in antibiotic-prescribing behaviour in nursing homes requires a change in nursing home staff's beliefs about and management of UTIs.,"['Nursing Home Residents', 'nursing homes, interviews with stakeholders, and a survey in general practice']",['Complex Intervention'],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0666822,Sustainable change in antibiotic-prescribing behaviour in nursing homes requires a change in nursing home staff's beliefs about and management of UTIs.,"[{'ForeName': 'Sif H', 'Initials': 'SH', 'LastName': 'Arnold', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Olesen', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Jette N', 'Initials': 'JN', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej 75, 2730 Herlev, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Holm', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Marius B', 'Initials': 'MB', 'LastName': 'Kousgaard', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9060360']
2178,32630571,The Effect of Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) on P3 Event-Related Potentials during a Bayesian Oddball Task.,"Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique associated with possible modulation of norepinephrinergic (NE) activity. NE is suspected to contribute to generation of the P3 event-related potential. Recent evidence has produced equivocal evidence whether taVNS influences the P3 in healthy individuals during oddball tasks. We examined the effect of taVNS on P3 amplitudes using a novel visual Bayesian oddball task, which presented 200 sequences of three stimuli. The three consecutive stimuli in each sequence are labelled Draw 1, Draw 2 and Draw 3. In total, 47 Subjects completed this visual Bayesian oddball task under randomised sham and active taVNS stimulation in parallel with an electroencephalographic (EEG) recording. We conducted exploratory analyses of the effect of taVNS on P3 amplitudes separately for Draws. We found typical oddball effects on P3 amplitudes at Draws 1 and 2, but not Draw 3. At Draw 2, the oddball effect was enhanced during active compared to sham taVNS stimulation. These data provide evidence that taVNS influences parietal P3 amplitudes under specific circumstances. Only P3 amplitudes at Draw 2 were affected, which may relate to closure of Bayesian inference after Draw 2. Our findings seemingly support previously reported links between taVNS and the NE system.",2020,Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique associated with possible modulation of norepinephrinergic (NE) activity.,"['47 Subjects completed this', 'healthy individuals during oddball tasks']","['Transcutaneous Auricular Vagal Nerve Stimulation (taVNS', 'visual Bayesian oddball task under randomised sham and active taVNS stimulation in parallel with an electroencephalographic (EEG) recording', 'taVNS', 'Transcutaneous auricular Vagal Nerve Stimulation (taVNS', 'NE']",['P3 amplitudes'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],47.0,0.0951838,Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique associated with possible modulation of norepinephrinergic (NE) activity.,"[{'ForeName': 'Claire V', 'Initials': 'CV', 'LastName': 'Warren', 'Affiliation': 'Clinic of Neurology, Hannover Medical School, 30519 Hannover, Germany.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Maraver', 'Affiliation': 'Institute of Psychology, Leiden University, 2333 Leiden, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de Luca', 'Affiliation': 'Institute of Psychology, Leiden University, 2333 Leiden, The Netherlands.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Kopp', 'Affiliation': 'Clinic of Neurology, Hannover Medical School, 30519 Hannover, Germany.'}]",Brain sciences,['10.3390/brainsci10060404']
2179,32631405,"Impact of vitamins A, B, C, D, and E supplementation on improvement and mortality rate in ICU patients with coronavirus-19: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


This study will evaluate the main hypothesis that supplementation with vitamins A, B, C, D, and E significantly improves the severity and mortality rate in ICU patients with COVID-19.
TRIAL DESIGN


This study is a randomized, single-blinded, two-arm (1:1 ratio) parallel group clinical trial.
PARTICIPANTS


We are conducting this study in patients with COVID-19 admitted to intensive care units at the Imam Khomeini Hospital Complex in Tehran, Iran. The inclusion criteria are as follows: (1) aged between 20 and 60 years, (2) both male and female patients with COVID-19, (3) clinical or definitive diagnosis (using polymerase chain reaction (PCR) test), (4) patients have not participated in other clinical trials, and (5) no renal or hepatic abnormalities. The exclusion criteria are as follows: (1) patients with specific and rare viral diseases such as HIV and (2) patients who have been undergoing chemotherapy for the past month.
INTERVENTION AND COMPARATOR


Duration of intervention: 7 days from randomization Intervention in the treatment group: Vitamin A 25,000 IU daily Vitamin D 600,000 IU once during study Vitamin E 300 IU twice daily Vitamin C is taken four times per day B vitamins are taken as a daily Soluvit [which included thiamine nitrate 3.1 mg, sodium riboflavin phosphate 4.9 mg (corresponding to vitamin B 2  3.6 mg), nicotinamide 40 mg, pyridoxine hydrochloride 4.9 mg (corresponding to vitamin B 6  4.0 mg), sodium pantothenate 16.5 mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113 mg (corresponding to vitamin C 100 mg), biotin 60 μg, folic acid 400 μg, and cyanocobalamin 5 μg] The control group will not receive any supplements or placebo. All supplements are made in Iran except for Soluvit (from Fresenius Kabi, New Zealand).
MAIN OUTCOMES


1. Weight, height, and BMI 2. Severity of pulmonary involvement according to CT scan 3. Respiratory support (invasive or non-invasive) 4. Percentage of oxygen saturation (SpO2 level) 5. Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6. The patient's body temperature 7. The presence or absence of involvement of organs other than the lungs (e.g., heart, liver, kidneys) 8. Duration of hospitalization 9. Mortality rate RANDOMIZATION: At baseline, eligible patients were randomly assigned to a 1:1 ratio to one of two groups: intervention and control. Block randomization is used based on the gender of patients.
BLINDING (MASKING)


Patients are unaware of being placed in the intervention or control groups after signing consent. All treatment staff will be aware of which group each of the patients is in due to the specific conditions of the ICU and the absence of placebo for the control group.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


The researchers plan to include 60 patients in total, with 30 patients in each group.
TRIAL STATUS


This is the first version of the protocol which started on April 2, 2020. Recruitment began April 2, 2020, and is expected to be complete by July 4, 2020.
TRIAL REGISTRATION


The Iranian Registry of Clinical Trials IRCT20200319046819N1 . Registered on April 4, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol (Fig. 1, Table 1).",2020,"Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6.","['The inclusion criteria are as follows: (1) aged between 20 and 60\u2009years, (2) both male and female patients with COVID-19, (3) clinical or definitive diagnosis (using polymerase chain reaction (PCR) test), (4) patients have not participated in other clinical trials, and (5) no renal or hepatic abnormalities', 'ICU patients with COVID-19', 'patients with COVID-19 admitted to intensive care units at the Imam Khomeini Hospital Complex in Tehran, Iran', '60 patients in total, with 30 patients in each group', '\n\n\nPatients are unaware of being placed in the intervention or control groups after signing consent', 'ICU patients with coronavirus-19', '1) patients with specific and rare viral diseases such as HIV and (2) patients who have been undergoing chemotherapy for the past month']","['vitamins A, B, C, D, and E supplementation', 'placebo', 'thiamine nitrate 3.1\u2009mg, sodium riboflavin phosphate 4.9\u2009mg (corresponding to vitamin B 2  3.6\u2009mg), nicotinamide 40\u2009mg, pyridoxine hydrochloride 4.9\u2009mg (corresponding to vitamin B 6  4.0\u2009mg), sodium pantothenate 16.5\u2009mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113\u2009mg (corresponding to vitamin C 100\u2009mg), biotin 60\u2009μg, folic acid 400\u2009μg, and cyanocobalamin 5\u2009μg']","['Weight, height, and BMI 2', 'Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6', 'severity and mortality rate', 'Percentage of oxygen saturation (SpO2 level', 'improvement and mortality rate']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039844', 'cui_str': 'Thiamine mononitrate'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0037548', 'cui_str': 'Riboflavin sodium phosphate'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0700496', 'cui_str': 'Pyridoxine hydrochloride'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0772245', 'cui_str': 'Sodium pantothenate'}, {'cui': 'C0030342', 'cui_str': 'Pantothenic Acid'}, {'cui': 'C0887557', 'cui_str': 'Sodium Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.202892,"Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6.","[{'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sama', 'Initials': 'S', 'LastName': 'Bitarafan', 'Affiliation': 'Iranian Center of Neurological Research (ICNR), Neuroscience Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Keshavarz Blvd, Tehran, 1419733141, Iran. bitarafans@gmail.com.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Hoseindokht', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Pathology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Amoozadeh', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Mahmoodi Ali Abadi', 'Affiliation': 'Department of Laboratory, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Foroumandi', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04547-0']
2180,32639518,Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial.,"Importance


Although lipoprotein(a) (Lp[a]) is a causal genetic risk factor for atherosclerotic cardiovascular disease, it remains unclear which patients with established atherosclerotic cardiovascular disease stand to benefit the most from Lp(a) lowering. Whether inflammation can modulate Lp(a)-associated cardiovascular (CV) risk during secondary prevention is unknown.
Objective


To examine whether Lp(a)-associated CV risk is modulated by systemic inflammation in optimally treated patients at high risk of CV disease.
Design, Setting, and Participants


A prespecified secondary post hoc analysis of the double-blind, multicenter randomized clinical Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes (ACCELERATE) trial was conducted between October 1, 2012, and December 31, 2013; the study was terminated October 12, 2015. The study was conducted at 543 academic and community hospitals in 36 countries among 12 092 patients at high risk of CV disease (acute coronary syndrome, stroke, peripheral arterial disease, or type 2 diabetes with coronary artery disease) with measurable Lp(a) and high-sensitivity C-reactive protein (hsCRP) levels during treatment. Statistical analysis for this post hoc analysis was performed from September 26, 2018, to March 28, 2020.
Interventions


Participants received evacetrapib, 130 mg/d, or matching placebo.
Main Outcomes and Measures


The ACCELERATE trial found no significant benefit or harm of evacetrapib on 30-month major adverse cardiovascular events (CV death, myocardial infarction [MI], stroke, coronary revascularization, or hospitalization for unstable angina). This secondary analysis evaluated rates of CV death, MI, and stroke across levels of Lp(a).
Results


High-sensitivity C-reactive protein and Lp(a) levels were measured in 10 503 patients (8135 men; 8561 white; 10 134 received concurrent statins; mean [SD] age, 64.6 [9.4] years). In fully adjusted analyses, in patients with hsCRP of 2 mg/L or more but not less than 2 mg/L, increasing quintiles of Lp(a) were significantly associated with greater rates of death, MI, and stroke (P = .006 for interaction). Each unit increase in log Lp(a) levels was associated with a 13% increased risk of CV death, nonfatal MI, or stroke only in those with hsCRP levels of 2 mg/L or more (P = .008 for interaction). There was also a significant stepwise relationship between increasing Lp(a) quintiles and time to first CV death, MI, or stroke (log-rank P < .001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
Conclusions and Relevance


Elevated Lp(a) levels during treatment are related to CV death, MI, and stroke when hsCRP levels are 2 mg/L or more but not less than 2mg/L. This finding suggests a potential benefit of lowering Lp(a) in patients with residual systemic inflammation despite receipt of optimal medical therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT01687998.",2020,".001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
","['Optimally Treated Patients With High-Risk Vascular Disease', '10 503 patients (8135 men; 8561 white; 10 134 received concurrent statins; mean [SD] age, 64.6 [9.4] years', 'Patients at a High Risk for Vascular Outcomes (ACCELERATE) trial was conducted between October 1, 2012, and December 31, 2013; the study was terminated October 12, 2015', '543 academic and community hospitals in 36 countries among 12 092 patients at high risk of CV disease (acute coronary syndrome, stroke, peripheral arterial disease, or type 2 diabetes with coronary artery disease) with measurable Lp(a) and high-sensitivity C-reactive protein (hsCRP) levels during treatment', 'patients with residual systemic inflammation despite receipt of optimal medical therapy', 'optimally treated patients at high risk of CV disease', 'patients with established atherosclerotic cardiovascular disease']","['C-Reactive Protein', 'lipoprotein(a) (Lp[a', 'Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib', 'evacetrapib, 130 mg/d, or matching placebo']","['30-month major adverse cardiovascular events (CV death, myocardial infarction [MI], stroke, coronary revascularization, or hospitalization for unstable angina', 'quintiles of Lp(a', 'hsCRP levels', 'Lipoprotein(a)-Associated Cardiovascular Risk', 'log Lp(a', 'High-sensitivity C-reactive protein and Lp(a) levels', 'rates of CV death, MI, and stroke across levels of Lp(a', 'Lp(a) quintiles and time to first CV death, MI, or stroke (log-rank P\u2009', 'rates of death, MI, and stroke', 'risk of CV death, nonfatal MI, or stroke']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3252279', 'cui_str': 'evacetrapib'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",12092.0,0.296263,".001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
","[{'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Benoit J', 'Initials': 'BJ', 'LastName': 'Arsenault', 'Affiliation': 'Québec Heart & Lung Institute, Université de Laval, Québec, Québec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'St John', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Riesmeyer', 'Affiliation': 'Eli Lilly, Indianapolis, Indiana.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Ruotolo', 'Affiliation': 'Eli Lilly, Indianapolis, Indiana.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McErlean', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'MonashHeart, Department of Cardiology, Monash University, Clayton, Victoria, Australia.'}]",JAMA cardiology,['10.1001/jamacardio.2020.2413']
2181,32639545,Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind Randomized Clinical Trial.,"Importance


Gynecological laparoscopies are one of the most common surgical procedures worldwide. Limited evidence exists on rates of surgical site infections in patients undergoing gynecological laparoscopies and strategies to prevent these infections.
Objective


To compare rates of port-site infections, organ or space infections, and any type of surgical site infections among patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions.
Design, Setting, and Participants


A double-blind randomized clinical trial was conducted between February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center. A total of 661 patients 18 years or older who underwent an elective operative laparoscopy for treatment of nonmalignant gynecological disorders were randomly assigned in a 1:1:1 ratio to have their skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine. Statistical analysis was performed from February 28, 2017, to November 26, 2018. Analyses were performed on a modified intention-to-treat basis.
Interventions


A total of 221 patients were randomized to have their skin prepared preoperatively with water-based povidone-iodine, 220 were randomized to alcohol-based povidone-iodine, and 220 were randomized to alcohol-based chlorhexidine. The patients were blinded to the solution used to clean their skin. Patients were followed up 1 and 4 weeks after surgery by a physician who was blinded to the skin preparation solution used at surgery. Evidence of infection according to Centers for Disease Control and Prevention criteria were documented.
Main Outcomes and Measures


The primary outcome of this study was port-site infection 30 days after surgery. Secondary outcomes were organ or space infections and any type of surgical site infections; the study also aimed to prospectively describe rates of surgical site infections in gynecological laparoscopies.
Results


Of the 661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis. The overall rate of port-site infection was 10.2% (65 of 640), rate of organ or space infection was 6.6% (42 of 640), and rate of any surgical site infection was 16.3% (104 of 640). The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
Conclusions and Relevance


Surgical site infections were more common than expected among patients who underwent gynecological laparoscopies. No skin preparation solution provided an advantage compared with the other solutions in reducing infection rates.
Trial Registration


http://anzctr.org.au Identifier: ACTRN12617000475347.",2020,"The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
","['patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions', 'February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center', '661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis', 'Patients', 'patients who underwent gynecological laparoscopies', 'patients undergoing gynecological laparoscopies', '221 patients were randomized to have their skin prepared preoperatively with', '661 patients 18 years or older who underwent an', 'for treatment of nonmalignant gynecological disorders']","['Surgical Skin Antisepsis', 'Gynecological Laparoscopic Surgery', 'water-based povidone-iodine', 'alcohol-based chlorhexidine', 'elective operative laparoscopy', 'povidone-iodine vs alcohol-based povidone-iodine', 'alcohol-based povidone-iodine', 'chlorhexidine vs alcohol-based povidone-iodine', 'chlorhexidine vs water-based povidone-iodine', 'skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine']","['surgical site infections in gynecological laparoscopies', 'overall rate of port-site infection', 'Surgical Site Infections', 'infection rates', 'rate of any surgical site infection', 'organ or space infections and any type of surgical site infections', 'rate of organ or space infection', 'odds ratio for port-site infection', 'rates of port-site infections, organ or space infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0574729', 'cui_str': 'Skin clean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",221.0,0.146845,"The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
","[{'ForeName': 'Uri P', 'Initials': 'UP', 'LastName': 'Dior', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Shamitha', 'Initials': 'S', 'LastName': 'Kathurusinghe', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Reddington', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': ""Department of Microbiology and Infectious Disease, The Royal Women's Hospital, Parkville, Australia.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Ang', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Healey', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}]",JAMA surgery,['10.1001/jamasurg.2020.1953']
2182,32639561,Effectiveness of Sequential Psychological and Medication Therapies for Insomnia Disorder: A Randomized Clinical Trial.,"Importance


Despite evidence of efficacious psychological and pharmacologic therapies for insomnia, there is little information about what first-line treatment should be and how best to proceed when initial treatment fails.
Objective


To evaluate the comparative efficacy of 4 treatment sequences involving psychological and medication therapies for insomnia and examine the moderating effect of psychiatric disorders on insomnia outcomes.
Design, Setting, and Participants


In a sequential multiple-assignment randomized trial, patients were assigned to first-stage therapy involving either behavioral therapy (BT; n = 104) or zolpidem (zolpidem; n = 107), and patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT]). The study took place at Institut Universitaire en Santé Mentale de Québec, Université Laval, Québec City, Québec, Canada, and at National Jewish Health, Denver, Colorado, and enrollment of patients took place from August 2012 through July 2017.
Main Outcomes and Measures


The primary end points were the treatment response and remission rates, defined by the Insomnia Severity Index total score.
Results


Patients included 211 adults (132 women; mean [SD] age, 45.6 [14.9] years) with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder. First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%; OR, 1.41; 95% CI, 0.75-2.65). Second-stage therapy produced significant increases in responders for the 2 conditions, starting with BT (BT to zolpidem, 40.6% to 62.7%; OR, 2.46; 95% CI, 1.14-5.30; BT to CT, 50.1% to 68.2%; OR, 2.09; 95% CI, 1.01-4.35) but no significant change following zolpidem treatment. Significant increase in percentage of remitters was observed in 2 of 4 therapy sequences (BT to zolpidem, 38.1% to 55.9%; OR, 2.06; 95% CI, 1.04-4.11; zolpidem to trazodone, 31.4% to 49.4%; OR, 2.13; 95% CI, 0.91-5.00). Although response/remission rates were lower among patients with psychiatric comorbidity, treatment sequences that involved BT followed by CT or zolpidem followed by trazodone yielded better outcomes for patients with comorbid insomnia. Response and remission rates were well sustained through the 12-month follow-up.
Conclusions and Relevance


Behavioral therapy and zolpidem medication produced equivalent response and remission rates. Adding a second treatment produced an added value for those whose insomnia failed to remit with initial therapies.
Trial Registration


ClinicalTrials.gov Identifier: NCT01651442.",2020,"First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%;","['patients with comorbid insomnia', 'Insomnia Disorder', 'Results\n\n\nPatients included 211 adults (132 women; mean [SD] age, 45.6 [14.9] years) with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder']","['behavioral therapy (BT; n\u2009=\u2009104) or zolpidem (zolpidem; n\u2009=\u2009107), and patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT', 'trazodone', 'Sequential Psychological and Medication Therapies', 'CT or zolpidem', 'BT or zolpidem', 'zolpidem']","['response/remission rates', 'equivalent response and remission rates', 'treatment response and remission rates, defined by the Insomnia Severity Index total score', 'Response and remission rates', 'percentage of remitters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",74.0,0.059307,"First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%;","[{'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Beaulieu-Bonneau', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ivers', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guay', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Bélanger', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cartwright', 'Affiliation': 'University of Colorado, Denver.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Lamy', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Busby', 'Affiliation': 'University of Colorado, Denver.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1767']
2183,32649493,Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether a short course of tamoxifen decreases bothersome bleeding in etonogestrel contraceptive implant users.
METHODS


In a 90-day, double-blind randomized control trial, we enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting. A sample size of 40 per group (N=80) was planned to compare 10 mg tamoxifen or placebo twice daily for 7 days after 3 consecutive days of bleeding or spotting no more than once per 30 days (maximum three treatments). Participants then entered a 90-day open-label study where all received tamoxifen if needed every 30 days (maximum three treatments). Participants used text messages to record daily bleeding patterns. Our primary outcome was the total number of consecutive amenorrhea days after the first treatment. Secondary outcomes included time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction.
RESULTS


From January 2017 to November 2018, 112 women enrolled in the study; 88 (79%) completed 90 days, and 79 (71%) completed 180 days. Participant characteristics did not differ between groups; mean age 24, majority identified as white not Hispanic with at least some college education. After the first treatment, the tamoxifen group reported an average of 9.8 (95% CI 4.6-15.0) more consecutive days of amenorrhea and more total days of no bleeding (amenorrhea or spotting) in the first 90 days (median 73.5 [range 24-89] vs 68 [range 11-81], P=.001). The placebo group showed a similar treatment benefit after first active use of tamoxifen in the open-label phase. At the end of the randomized study (first 90 days), women who received tamoxifen reported higher satisfaction (median 62 mm [range 16-100]) than those treated with placebo (46 mm [range 0-100]; P=.023).
CONCLUSION


A short course of tamoxifen reduces problematic bleeding and improves satisfaction in users of etonogestrel implants.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02903121.",2020,"Secondary outcomes included time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction.
","['From January 2017 to November 2018, 112 women enrolled in the study; 88 (79%) completed 90 days, and 79 (71%) completed 180 days', 'enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting', 'users of etonogestrel implants', 'etonogestrel contraceptive implant users', 'Contraceptive Implant Users']","['placebo', 'tamoxifen', 'tamoxifen or placebo']","['total number of consecutive amenorrhea days', 'consecutive days of amenorrhea and more total days of no bleeding (amenorrhea or spotting', 'time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction', 'bothersome bleeding', 'higher satisfaction']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1306383', 'cui_str': 'Etonogestrel Drug Implant'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}]",112.0,0.624149,"Secondary outcomes included time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction.
","[{'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Edelman', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon; the Department of Obstetrics and Gynecology, University of Hawaii, Honolulu, Hawaii; and the Department of Obstetrics & Gynecology, the Permanente Medical Group, San Leandro, California.'}, {'ForeName': 'Bliss', 'Initials': 'B', 'LastName': 'Kaneshiro', 'Affiliation': ''}, {'ForeName': 'Katharine B', 'Initials': 'KB', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hauschildt', 'Affiliation': ''}, {'ForeName': 'Kise', 'Initials': 'K', 'LastName': 'Bond', 'Affiliation': ''}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Boniface', 'Affiliation': ''}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003896']
2184,32650033,Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications.,"AIM


Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required.
METHODS


We compared improvement in glycaemic control in a pooled set of people assigned to the ""placebo"" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated.
RESULTS


The overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between -0.23% (-2.50 mmol/mol) and -0.32% (-3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months.
CONCLUSIONS


Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.",2020,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"['people with diabetes and their healthcare team', 'people with diabetes', 'younger and older adults with diabetes having comorbidities and progressive complications', 'people living with diabetes']","['sham or non-pharmacological intervention', 'placebo']","['metabolic parameters', 'fasting plasma glucose', 'Mean change in HbA1c (ANCOVA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.202893,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"[{'ForeName': 'William David', 'Initials': 'WD', 'LastName': 'Strain', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom; Academic Department of Healthcare for the Elderly, Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom. Electronic address: d.strain@exeter.ac.uk.'}, {'ForeName': 'Päivi Maria', 'Initials': 'PM', 'LastName': 'Paldánius', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108310']
2185,32650223,Skin carotenoids are inversely associated with adiposity in breast cancer survivors.,"Carotenoids are antioxidants which may mitigate some of the adverse effects of obesity, a condition associated with poor outcomes in breast cancer patients. We hypothesized that baseline skin carotenoids would be inversely associated with adiposity in breast cancer survivors and would increase with weight loss. Skin carotenoid score (SCS) was assessed by resonance Raman spectroscopy in breast cancer survivors (body mass index ≥25 kg/m 2 ) enrolled in a 6-month randomized controlled weight loss trial (n = 47). Measurements included total body fat using dual-energy X-ray absorptiometry, height, weight, waist and hip circumference, dietary intake, and serum biomarkers. Associations between SCS, adiposity measures, and serum biomarkers were assessed at baseline, as was the change in SCS from baseline to 6 months, in the intervention and usual care groups. At baseline, SCS was inversely correlated with all adiposity measures (P ≤ .05). In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20). Baseline SCS was significantly inversely associated with log C-reactive protein levels (regression coefficient β ± SE: -0.051± 0.019; P = .011) and log leptin (β ± SE: -0.019± 0.009; P = .046), but the associations were no longer significant after adjustment for adiposity. Over the 6-month study, the intervention group had a 17.6% increase in SCS compared to a 1.5% decrease in the usual care group (P = .28). In our study of overweight and obese breast cancer survivors, dual-energy X-ray absorptiometry-measured body fat explained a large portion of the variation in skin carotenoids at baseline, suggesting a stronger association than that previously seen in studies using less accurate measures of adiposity.",2020,"In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20).","['breast cancer patients', 'breast cancer survivors', 'overweight and obese breast cancer survivors', 'breast cancer survivors (body mass index ≥25\u202fkg/m 2 ) enrolled in a 6-month randomized controlled weight loss trial (n\u202f=\u202f47']",[],"['Skin carotenoid score (SCS', 'log C-reactive protein levels', 'SCS', 'SCS, adiposity measures, and serum biomarkers', 'weight loss', 'adiposity measures', 'total body fat using dual-energy X-ray absorptiometry, height, weight, waist and hip circumference, dietary intake, and serum biomarkers']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0209892,"In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20).","[{'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: brenda.cartmel@yale.edu.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: chelsea.anderson@cancer.org.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: melinda.irwin@yale.edu.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: maura.harrigan@yale.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale Cancer Center, PO Box 208028, New Haven, CT 06519; Yale School of Medicine, 333 Cedar St, New Haven, CT 06511. Electronic address: tara.sanft@yale.edu.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: fangyong.li@yale.edu.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Gellermann', 'Affiliation': 'Longevity Link Corporation, 391 Chipeta Way, Suite E, Salt Lake City, UT 84108. Electronic address: werner@longevitylinkcorporation.com.'}, {'ForeName': 'Igor V', 'Initials': 'IV', 'LastName': 'Ermakov', 'Affiliation': 'Longevity Link Corporation, 391 Chipeta Way, Suite E, Salt Lake City, UT 84108. Electronic address: igor@longevitylinkcorporation.com.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ferrucci', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: leah.ferrucci@yale.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.012']
2186,32650261,Efficacy and safety of systemic tranexamic acid administration in total knee arthroplasty: A case series.,"INTRODUCTION


Total knee arthroplasty (TKA) are associated with significant postoperative blood loss. Tranexamic acid (TXA) is a potent agent with antifibrinolytic activity, that can be administered via the intravenous (IV) and/or topical (intra-articular, IA) route, which can possibly interrupt the cascade of events due to hemostatic irregularities close to the source of bleeding. However, the literature contains scarce scientific evidence related to IV only TXA usage in TKA. The current study aims to compare the outcome between patients who were administered IV TXA and a control group in terms of blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE).
METHODS


110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received IV TXA; and 2) 76 patients in the control group. In the TXA group, patients received an IV TXA dose of 1 g, 30 min before incision. Two drains were placed.
RESULTS


Usage of IV TXA showed better results when compared to the control group in terms of mean blood transfusion (0.5 less transfusion during hospital stay), hemoglobin drop (10%). No cases of DVT or TE were noted among the two study groups.
CONCLUSION


Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA. Moreover, TXA use is safe in terms of incidence of symptomatic DVT and TE.",2020,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"['total knee arthroplasty', '110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received']","['IV TXA', 'TXA', 'systemic tranexamic acid', 'Tranexamic acid (TXA', 'Total knee arthroplasty (TKA']","['mean blood transfusion', 'DVT or TE', 'Efficacy and safety', 'blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.0314014,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maalouly', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Josephmaalouly2@gmail.com.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'El Assaad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Donna.elassaad@lau.edu.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ayoubi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: rami.ayoubi1@gmail.com.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Tawk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Antoniostawk@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Aouad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Dany_aouad@hotmail.com.'}, {'ForeName': 'Georgio', 'Initials': 'G', 'LastName': 'Lati', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Georgio.lati@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'El Rassi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: gselrassi@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2020.06.077']
2187,32650548,A Multidisciplinary Approach for Improving Quality of Life and Self-Management in Diabetic Kidney Disease: A Crossover Study.,"Individuals with diabetic kidney disease are at high risk of complications and challenged to self-manage. Previous research suggested that multidisciplinary approaches would improve health outcomes. This study investigated the effect of a multidisciplinary self-management approach of diabetic kidney disease on quality of life, and self-management, glycemic control, and renal function. A uniform balanced crossover design was used because it attains a high level of statistical power with a lower sample size. A total of 32 participants (aged 67.8 ± 10.8) were randomized into four study arms. In differing sequences, each participant was treated twice with three months of usual care alternated with three months of multidisciplinary management. The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  p  = 0.002, 56.84 vs. 37.02;  p  = 0.000, 53.84 vs. 39.77;  p  = 0.008; 95% CI). Antihypertensive medication engagement was high across the study period (Mean = 95.38%, Min = 69%, Max = 100%). Glycemic control and renal function indicators were similar for the intervention and the usual care. Studies are needed to determine how the new recommended therapies for diabetic kidney disease such as SGLT2 inhibitors and GLP-1 receptor agonists impact on self-management and quality of life.",2020,"The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  ","['Diabetic Kidney Disease', '32 participants (aged 67.8 ± 10.8', 'Individuals with diabetic kidney disease']",['multidisciplinary self-management approach'],"['Antihypertensive medication engagement', 'Glycemic control and renal function indicators', 'Quality of Life and Self-Management', 'self-care activities, general diet habits, diabetes diet habits, and blood sugar testing', 'health outcomes', 'quality of life, and self-management, glycemic control, and renal function', 'present dimension of quality of life']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",32.0,0.0424056,"The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  ","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Helou', 'Affiliation': 'School of Health Sciences (HESAV), HES-SO University of Applied Sciences and Arts Western Switzerland, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Talhouedec', 'Affiliation': 'Clinique de La Source, 1004 Lausanne, Switzerland.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zumstein-Shaha', 'Affiliation': 'Department of Health, Bern University of Applied Sciences, 3010 Bern, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zanchi', 'Affiliation': 'Service of Nephrology and Hypertension, Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9072160']
2188,32650604,Nine Months of a Structured Multisport Program Improve Physical Fitness in Preschool Children: A Quasi-Experimental Study.,"Research in preschool children that investigates the impact of different exercise interventions on physical fitness is limited. This pre-post study was aimed at determining if participation in a nine-month structured multisport program (MSG; n = 38) could enhance physical fitness components compared to a formal exercise program (control group (CG); n = 36) among preschool children. Physical fitness was assessed using standardized tests (the standing long jump, sit and reach, 20 m sprint, sit-ups for 30 s, bent-arm hang, medicine ball throw (MBT), grip strength, 4 × 10 m shuttle run, and 20 m shuttle run tests). The structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week. The control group was free of any programmed exercise except for the obligatory program in kindergartens. A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05). There was no significant group-by-time interaction effect for the 20 m sprint test ( p  = 0.794) or for the 20 m shuttle run test ( p  = 0.549). Moreover, the MSG and CG performance in the MBT and 20 m shuttle run tests improved to a similar extent from pre- to post-test. Our results indicate that compared to the formal plan, the structured multisport program led to a sustained improvement in physical fitness in healthy 5-to-6-year old children.",2020,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05).","['Preschool Children', 'n = 36) among preschool children', 'healthy 5-to-6-year old children', 'preschool children']","['structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week', 'exercise interventions', 'Structured Multisport Program', 'physical fitness components compared to a formal exercise program (control group (CG']","['Physical Fitness', 'time interaction effect', 'physical fitness', 'Physical fitness', 'MSG and CG performance']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",38.0,0.019258,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05).","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Popović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Cvetković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Draženka', 'Initials': 'D', 'LastName': 'Mačak', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Tijana', 'Initials': 'T', 'LastName': 'Šćepanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Čokorilo', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Belić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Andrašić', 'Affiliation': 'Faculty of Economics, University of Novi Sad, 24000 Subotica, Serbia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Faculty of Sport, University of Ljubljana, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17144935']
2189,32650760,Evaluating the effectiveness of a CRSCE-based de-escalation training program among psychiatric nurses: a study protocol for a cluster randomized controlled trial.,"BACKGROUND


The high incidence of workplace violence (WPV) in clinical mental health settings has caused a series of negative impacts on nurses, which has subsequently increased public concern. De-escalation (DE) is recommended as a training program which aims at providing nurses with skills and strategies to more effectively respond and manage WPV. Very few studies have examined the effectiveness of DE training, with current studies possessing various limitations due to their design and small sample sizes. By using a cluster randomized controlled design, the proposed study aims to evaluate the effectiveness of a CRCSE-based DE training programs among psychiatric nurses.
METHOD


A cluster randomized controlled trial, with a 6-month follow-up period after the end of the intervention, will be conducted among psychiatric hospitals in Guangdong, China. The randomization unit is each involved psychiatric hospital. Participants in the control group will be assigned to routine WPV management training, participants of the intervention group will undergo the same training while additionally receiving DE training. The DE training will include the following five modules: communication, response, solution, care, and environment (CRSCE). Primary outcomes are objective clinical indicators, which will be extracted from the information systems of the enrolled hospitals. These include the incidence of WPV, injuries caused by WPV, and the use of coercion (physical restraint and seclusion) by nurses. Secondary outcomes, aims at evaluating the effects of DE training on nurses, include the capacity of DE, DE confidence, level of job burnout, and professional quality of life. Data will be collected at baseline (T 0 ), at 3 months (T 1 , intervention completed), and at 6 months after intervention (T 2 , follow-up).
DISCUSSION


This study will offer trial-based evidence of the efficacy of a DE training program targeted at WPV among psychiatric nurses. DE training is expected to reduce both the total incidence and negative impacts of WPV, with additional improvements in psychiatric nurses' coping skills.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900022211 . Prospectively registered on 30 March 2019.",2020,"DE training is expected to reduce both the total incidence and negative impacts of WPV, with additional improvements in psychiatric nurses' coping skills.
","['psychiatric nurses', 'psychiatric hospitals in Guangdong, China']","['CRSCE-based de-escalation training program', 'DE training program', 'CRCSE-based DE training programs', 'DE training', 'routine WPV management training, participants of the intervention group will undergo the same training while additionally receiving DE training']","['effects of DE training on nurses, include the capacity of DE, DE confidence, level of job burnout, and professional quality of life']","[{'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3658335', 'cui_str': 'Workplace Violence'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0983117,"DE training is expected to reduce both the total incidence and negative impacts of WPV, with additional improvements in psychiatric nurses' coping skills.
","[{'ForeName': 'Junrong', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China. yejunrong1580@qq.com.'}, {'ForeName': 'Aixiang', 'Initials': 'A', 'LastName': 'Xiao', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Early Intervention, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Zhichun', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Adult Psychiatry, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Sijue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China.'}, {'ForeName': 'Jiankui', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingzhou Central Hospital, Jingzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Intensive Care Unit, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yun Lei', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingzhou Central Hospital, Jingzhou, China.'}]",BMC health services research,['10.1186/s12913-020-05506-w']
2190,32650771,Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial.,"BACKGROUND


Despite the numerous healthcare smartphone applications for self-management of diabetes, patients often fail to use these applications consistently due to various limitations, including difficulty in inputting dietary information by text search and inconvenient and non-persistent self-glucose measurement by home glucometer. We plan to apply a digital integrated healthcare platform using an artificial intelligence (AI)-based dietary management solution and a continuous glucose monitoring system (CGMS) to overcome those limitations. Furthermore, medical staff will be performing monitoring and intervention to encourage continuous use of the program. The aim of this trial is to examine the efficacy of the program in patients with type 2 diabetes mellitus (T2DM) who have HbA1c 53-69 mmol/mol (7.0-8.5%) and body mass index (BMI) ≥ 23 mg/m 2 .
METHODS


This is a 48-week, open-label, randomized, multicenter trial consisting of patients with type 2 diabetes. The patients will be randomly assigned to three groups: control group A will receive routine diabetes care; experimental group B will use the digital integrated healthcare platform by themselves without feedback; and experimental group C will use the digital integrated healthcare platform with continuous glucose monitoring and feedback from medical staff. There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48. The primary end point is change in HbA1c from baseline to six months after the intervention.
DISCUSSION


This trial will verify the effectiveness of a digital integrated healthcare platform with an AI-driven dietary solution and a real-time CGMS in patients with T2DM.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04161170, registered on 08 November 2019. https://clinicaltrials.gov/ct2/show/NCT04161170?term=NCT04161170&draw=2&rank=1.",2020,"There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48.","['diabetes management', 'registered on 08 November 2019', 'patients with type 2 diabetes mellitus (T2DM) who have HbA1c 53-69\u2009mmol/mol (7.0-8.5%) and body mass index (BMI)\u2009≥\u200923\u2009mg/m 2 .\nMETHODS', 'patients with type 2 diabetes', 'patients with T2DM']","['digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system', 'control group A will receive routine diabetes care; experimental group B will use the digital integrated healthcare platform by themselves without feedback; and experimental group C will use the digital integrated healthcare platform with continuous glucose monitoring and feedback from medical staff', 'digital integrated healthcare platform with an AI-driven dietary solution', 'digital integrated healthcare platform using an artificial intelligence (AI)-based dietary management solution and a continuous glucose monitoring system (CGMS']",['change in HbA1c'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0666465,"There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48.","[{'ForeName': 'Sung Woon', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gyuri', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'You-Cheol', 'Initials': 'YC', 'LastName': 'Hwang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Woo Je', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyunjin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Amazing Food Solution, Inc., Seoul, South Korea.'}, {'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. jaehyeon@skku.edu.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01179-x']
2191,32650801,Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a 1-year follow up.,"BACKGROUND


Osteoarthritis is the most prevalent type of arthritis, which significantly impacts the patient's mobility and quality of life. Pharmacological treatments for osteoarthritis, such as corticosteroids, produce an immediate reduction of the patient's pain as well as an improvement in the patient's mobility and quality of life, but with a limited long-term efficacy. In this context, platelet-rich plasma (PRP) infiltrations represent a therapeutic tool due to its trophic properties and its ability to control inflammatory processes, especially in musculoskeletal applications. The aim of this study is to evaluate and compare the clinical benefits of PRP when injected intra-articularly vs a commonly used corticosteroid (CS, triamcinolone acetonide, Kenalog®) in patients affected by mild to moderate symptomatic knee osteoarthritis.
METHODS


Forty patients affected by symptomatic radiologically confirmed knee osteoarthritis (Kellgren-Lawrence grades II-III) were enrolled in this randomized study. Patients randomized in the PRP group (n = 20) received an intra-articular injection of PRP (8 mL) while patients randomized in the CS group (n = 20) received an intra-articular injection of triamcinolone acetonide (1 mL of 40 mg/mL) plus lidocaine (5 mL of 2%). The pain and function of the target knee were evaluated by the VAS, IKDC, and KSS scales at the baseline (V1), 1 week (V2), 5 weeks (V3), 15 weeks (V4), 30 weeks (V5), and 1 year (V6) after treatment.
RESULTS


No serious adverse effects were observed during the follow-up period. A mild synovitis was registered in 15 patients (75%) in the PRP group within the first week after treatment which resolved spontaneously. Both treatments were effective in relieving pain and improving the knee function in the very short-term follow-up visit (1 week). A high improvement of the subjective scores was observed for both groups up to 5 weeks, with no significative differences between the groups for the VAS, IKDC, or KSS. After 15 weeks of follow-up, the PRP group showed significative improvements in all scores when compared to the CS group. Overall, the patients who received PRP treatment had better outcomes in a longer follow-up visit (up to 1 year) than those who received CS.
CONCLUSIONS


A single PRP or CS intra-articular injection is safe and improves the short-term scores of pain and the knee function in patients affected by mild to moderate symptomatic knee OA (with no significant differences between the groups). PRP demonstrated a statistically significant improvement over CS in a 1-year follow-up. This study was registered at ISRCTN with the ID ISRCTN46024618.",2020,A single PRP or CS intra-articular injection is safe and improves the short-term scores of pain and the knee function in patients affected by mild to moderate symptomatic knee OA (with no significant differences between the groups).,"['patients affected by mild to moderate symptomatic knee osteoarthritis', 'moderate knee osteoarthritis', 'Forty patients affected by symptomatic radiologically confirmed knee osteoarthritis (Kellgren-Lawrence grades II-III']","['PRP', 'triamcinolone acetonide (1\u2009mL of 40\u2009mg/mL) plus lidocaine', 'Intra-articular platelet-rich plasma vs corticosteroids', 'corticosteroid (CS, triamcinolone acetonide, Kenalog®', 'intra-articular injection of PRP']","['pain and function of the target knee', 'knee function', 'mild synovitis', 'VAS, IKDC, and KSS scales', 'subjective scores', 'relieving pain', 'serious adverse effects']","[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0699689', 'cui_str': 'Kenalog'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",40.0,0.042986,A single PRP or CS intra-articular injection is safe and improves the short-term scores of pain and the knee function in patients affected by mild to moderate symptomatic knee OA (with no significant differences between the groups).,"[{'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Elksniņš-Finogejevs', 'Affiliation': 'Faculty of Continuing Education, Rīga Stradiņš University, Riga, Latvia. andrejs.finogejevs@orto.lv.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vidal', 'Affiliation': 'Laboratorios Fidia Farmacéutica S.L.U, Madrid, Spain.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Peredistijs', 'Affiliation': '""ORTO klinika"" Ltd., Riga, Latvia.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01753-z']
2192,32650814,Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial.,"BACKGROUND


The prevalence of pneumonia complicating stroke in acute phase has a poor prognosis and higher risk for death. Oral opportunistic pathogens have been reported to be associated with pneumonia among people with compromised health. Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens. This study evaluates the effectiveness of oral health promotions in reducing the prevalence of pneumonia via its effects on composition and relative abundance of oral opportunistic pathogens.
METHODS/DESIGN


This study is a randomized, single-blind, parallel trial of 6 months duration. The study is being conducted at one of the largest medical teaching hospitals in Hefei, China. A total of 166 patients with stroke and free from any post-stroke complication will be recruited. After enrollment, patients will be randomized to one of the following groups: (1) oral hygiene instruction (OHI) or (2) OHI, 6-month use of powered tooth brushing, and 0.2% chlorhexidine gluconate mouth rinse (10 ml twice daily). The primary outcome is the prevalence of pneumonia complicating stroke. Patients will be monitored closely for any occurrence of pneumonia over the entire period of this trial. Oral rinse samples will be collected at baseline and multiple follow-up reviews (3, 5, 7 days, and 1, 3, 6 months after baseline). Next-generation sequencing will be employed to detect composition and relative abundances of the microorganism in the oral rinse samples. Questionnaire interviews and clinical oral examinations will be conducted at baseline and 1, 3, and 6 months after baseline.
DISCUSSION


The findings of this trial will provide evidence whether oral health promotion intervention is effective in reducing the prevalence of pneumonia complicating stroke via its effect on the oral microbiome. The analysis of the outcomes of this trial is empowered by metagenomic analysis at 16S rRNA level, which is more sensitive and comprehensive to help us detect how oral health promotion inventions affect the oral microbiome in terms of its composition, relative abundance, and interactions between species, which all may contribute to the occurrence of pneumonia complicating stroke.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04095780 . Registered on 19 September 2019.",2020,"Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens.","['166 patients with stroke and free from any post-stroke complication will be recruited', 'patients with stroke in acute phase', 'people with compromised health', 'largest medical teaching hospitals in Hefei, China', 'patients with stroke']","['Oral health promotion', 'oral hygiene instruction (OHI) or (2) OHI, 6-month use of powered tooth brushing, and 0.2% chlorhexidine gluconate mouth rinse', 'oral health promotions', 'oral health promotion interventions', 'oral health promotion intervention']",['prevalence of pneumonia complicating stroke'],"[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0150290', 'cui_str': 'Oral health promotion'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",166.0,0.247406,"Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens.","[{'ForeName': 'Juncang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.""}, {'ForeName': 'Yuanchang', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.""}, {'ForeName': 'Edward C M', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Department of Dental Public Health, Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong.'}, {'ForeName': 'Yinliang', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.""}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Oral Diseases Research of Anhui Province, Stomatological Hospital & College, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Quan-Li', 'Initials': 'QL', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Oral Diseases Research of Anhui Province, Stomatological Hospital & College, Anhui Medical University, Hefei, China. ql-li@126.com.'}, {'ForeName': 'Ruoxi', 'Initials': 'R', 'LastName': 'Dai', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China. u3001283@connect.hku.hk.""}]",Trials,['10.1186/s13063-020-04528-3']
2193,32652432,MR enterocolonography in patients with Crohn's disease and healthy volunteers - Do we achieve diagnostic bowel distension?,"PURPOSE


The aim of our prospective randomized study was to assess diagnostic quality and stability of bowel distension in patients with Crohn's disease (CD) and healthy volunteers subjected to synchronous magnetic resonance enterography and colonography (MREC), as well as to test the role of water enema and intravenous spasmolytics. The influence of gastric content, age, gender, and body mass on bowel distension was also evaluated.
METHOD


Study groups included 164 CD patients and 53 healthy volunteers. After bowel preparation, randomized subgroups started ingestion ≥1000 mL of hyperosmolar solution within 30, 45, 60, 75, and 90 min before admission to MRI, respectively. Patients were examined in prone position and water enema was applied. Spasmolytics were administered prior to I.V. gadolinium. Distension of five bowel segments was independently assessed by two experienced radiologists.
RESULTS


MREC yields diagnostic distension of the jejunum in 81.1 % and 79.2 % patients in the CD group and controls, respectively. For the terminal ileum it was >94 % in both groups. Good and excellent distension was achieved in other bowel segments. Distension was maintained up to 75 min from the start of oral ingestion. Water enema and spasmolytics significantly and independently improved distension of the small bowel. Distension of the cecum after spasmolytics was decreased. Gastric content, age, gender and body mass had no significant influence of bowel distension.
CONCLUSIONS


MREC enables diagnostic distension of the colon and ileum (including terminal segment) in CD patients and healthy volunteers and diagnostically acceptable distension of the jejunum.",2020,"Gastric content, age, gender and body mass had no significant influence of bowel distension.
","['Study groups included 164 CD patients and 53 healthy volunteers', ""patients with Crohn's disease (CD) and healthy volunteers"", ""patients with Crohn's disease and healthy volunteers"", 'CD patients and healthy volunteers']","['ingestion ≥1000\u202fmL of hyperosmolar solution', 'gadolinium', 'synchronous magnetic resonance enterography and colonography (MREC', 'MR enterocolonography']","['diagnostic quality and stability of bowel distension', 'MREC yields diagnostic distension', 'Distension', 'Good and excellent distension', 'distension of the small bowel', 'Distension of five bowel segments', 'bowel distension']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C4274338', 'cui_str': 'Magnetic resonance enterography'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C4274338', 'cui_str': 'Magnetic resonance enterography'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]",164.0,0.0222338,"Gastric content, age, gender and body mass had no significant influence of bowel distension.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tkalčić', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Matana Kaštelan', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Grubešić', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mijandrušić Sinčić', 'Affiliation': 'Department of Internal Medicine, Clinical Hospital Center of Rijeka, Rijeka, Croatia; Faculty of Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Milić', 'Affiliation': 'Department of Internal Medicine, Clinical Hospital Center of Rijeka, Rijeka, Croatia; Faculty of Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miletić', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia; Faculty of Medicine, University of Rijeka, Rijeka, Croatia. Electronic address: damir.miletic@medri.uniri.hr.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109100']
2194,32639460,"A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants.","BACKGROUND


Pneumococcal disease remains a public health priority worldwide. This phase 2 study (V114-008; NCT02987972; EudraCT 2016-001117-25) compared safety and immunogenicity of 2 clinical lots of V114 (investigational 15-valent pneumococcal vaccine: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F*, 23F, 33F*) to 13-valent pneumococcal conjugate vaccine (PCV13) in healthy infants (*serotypes unique to V114).
METHODS


Healthy infants 6-12 weeks old were randomized to receive a 4-dose regimen of V114 Lot 1, V114 Lot 2 or PCV13 at 2, 4, 6 and 12-15 months old. Adverse events were evaluated after each dose. Primary immunogenicity endpoint was to demonstrate noninferiority of V114 Lot 1 and V114 Lot 2 relative to PCV13 based on proportion of infants achieving serotype-specific IgG concentration ≥0.35 µg/mL for 13 serotypes shared with PCV13 at 1 month postdose 3 (PD3). Serotype-specific IgG geometric mean concentrations (GMCs) for all 15 V114 serotypes were measured at PD3, predose 4 and 1 month postdose 4 (PD4).
RESULTS


Overall, 1044 of 1051 randomized infants received ≥1 dose of vaccine (V114 Lot 1 [n = 350], V114 Lot 2 [n = 347] or PCV13 [n = 347]). Adverse events were generally comparable across groups. At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13. IgG GMCs were comparable among V114 and PCV13 recipients at PD3 and PD4. Serotype 3 responses were higher following receipt of V114 than PCV13. Both V114 lots induced higher GMCs than PCV13 to the 2 unique V114 serotypes.
CONCLUSIONS


Immunogenicity of both V114 lots was noninferior to PCV13 for all 13 shared serotypes between the 2 vaccines and displayed comparable safety and tolerability profiles to PCV13.",2020,"At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13.","['healthy infants (*serotypes unique to V114', 'Healthy infants 6-12 weeks old', 'Healthy Infants']","['4-dose regimen of V114 Lot 1, V114 Lot 2 or PCV13', 'vaccine', '13-Valent Pneumococcal Conjugate Vaccine', '13-valent pneumococcal conjugate vaccine (PCV13', 'V114 (investigational 15-valent pneumococcal vaccine']","['IgG GMCs', 'Serotype-specific IgG geometric mean concentrations (GMCs', 'Adverse events', 'safety and immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0757769', 'cui_str': 'PLAGL1 protein, human'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1051.0,0.0584867,"At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13.","[{'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Platt', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'Soroka Medical Center, Research, Beersheba, Israel.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Tapiero', 'Affiliation': 'CHU Sainte-Justine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Clifford', 'Affiliation': 'Coastal Pediatric Research, Charleston, South Carolina.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Oakland, California.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hurley', 'Affiliation': 'Cottonwood Pediatrics, Research, Murray, Utah.'}, {'ForeName': 'Tulin', 'Initials': 'T', 'LastName': 'Shekar', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hurtado', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Shu-Chih', 'Initials': 'SC', 'LastName': 'Su', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Nolan', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Camilo J', 'Initials': 'CJ', 'LastName': 'Acosta', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'McFetridge', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bickham', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Luwy K', 'Initials': 'LK', 'LastName': 'Musey', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002765']
2195,32639610,Long-term outcomes of anterior cruciate ligament reconstruction surgery: 2020 OREF clinical research award paper.,"ACL injuries place the knee at risk for post-traumatic osteoarthritis (PTOA) despite surgical anterior cruciate ligament (ACL) reconstruction. One parameter thought to affect PTOA risk is the initial graft tension. This randomized controlled trial (RCT) was designed to compare outcomes between two graft tensioning protocols that bracket the range commonly used. At 7 years postsurgery, we determined that most outcomes between the two tension groups were not significantly different, that they were inferior to an uninjured matched control group, and that PTOA was progressing in both groups relative to controls. The trial database was also leveraged to gain insight into mechanisms of PTOA following ACL injury. We determined that the inflammatory response at the time of injury undermines one of the joint's lubricating mechanisms. We learned that patients continue to protect their surgical knee 5 years postinjury compared to controls during a jump-pivot activity. We also established that presurgical knee function and mental health were correlated with symptomatic PTOA at 7 years, that there were specific anatomical factors associated with poor outcomes, and that there were no changes in outcomes due to tunnel widening in patients receiving hamstring tendon autografts. We also validated a magnetic resonance imaging technique to noninvasively assess graft strength. In conclusion, the RCT determined that initial graft tensioning does not have a major influence on 7-year outcomes. Therefore, surgeons can reconstruct the ACL using a graft tensioning protocol that is within the window of the two graft tensioning techniques evaluated in this RCT.",2020,"At 7-years post-surgery, we determined that most outcomes between the two tension groups were not significantly different, that they were inferior to an uninjured matched control group, and that PTOA was progressing in the both groups relative to controls.",['patients receiving hamstring tendon autografts'],"['surgical ACL reconstruction (ACLR', 'Anterior Cruciate Ligament Reconstruction Surgery']",['pre-surgical knee function and mental health'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0307706,"At 7-years post-surgery, we determined that most outcomes between the two tension groups were not significantly different, that they were inferior to an uninjured matched control group, and that PTOA was progressing in the both groups relative to controls.","[{'ForeName': 'Braden C', 'Initials': 'BC', 'LastName': 'Fleming', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Fadale', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hulstyn', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Shalvoy', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Tung', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Badger', 'Affiliation': 'Department of Medical Biostatistics, University of Vermont, Burlington, Vermont.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24794']
2196,32639634,Caffeine citrate maintenance doses effect on extubation and apnea postventilation in preterm infants.,"BACKGROUND


Caffeine citrate is used to prevent apnea in premature infants and help in extubation of invasive ventilation, but the optimal dose remains undetermined.
METHODS


Neonates born at less than 30 weeks gestation who had received invasive ventilation for at least 48 hours and a loading dose of 20 mg/kg caffeine citrate were randomly assigned into high (10 mg/kg daily) or low (5 mg/kg daily) maintenance dose groups. The drug was discontinued if no apnea occurred for 7 consecutive days.
RESULTS


A total of 111 infants were assigned into the high (54) or low (57) dose groups. Extubation failure (16.7% vs 36.8%), age of extubation (8.2 ± 2.1 vs 10.7 ± 2.3 day), duration of invasive ventilation (7.2 ± 2.1 vs 8.5 ± 2.4 day), duration of ventilation before extubation (8.0 ± 1.8 vs 10.1 ± 1.9 day), and number of days of apnea (1.8 ± 1.3 vs 3.2 ± 1.1 day) were significantly lower in the high dose group than the low dose group. Difference in time until failure (6.7 ± 1.7d vs 7.0 ± 1.9d) and duration of nasal continuous positive airway pressure(7.8 ± 1.8 vs 8.0 ± 2.2 day) were not significant. Furthermore, no significant differences in the incidence of tachycardia (9.3% vs 12.3%), abdominal distension (16.7% vs 12.3%), feeding intolerance (3.7% vs 5.3%), or irritability (7.4% vs 5.3%) were observed between groups.
CONCLUSIONS


A higher maintenance dose of caffeine citrate reduced the incidence of extubation failure and apnea of prematurity without increasing the occurrence of adverse reactions.",2020,"Furthermore, no significant differences in the incidence of tachycardia (9.3% vs 12.3%), abdominal distension (16.7% vs 12.3%), feeding intolerance (3.7% vs 5.3%) or irritability (7.4% vs 5.3%) were observed between groups.
","['Neonates born at less than 30 weeks gestation who had received invasive ventilation for at least 48 hours and a loading dose of 20 mg/kg', 'preterm infants', 'A total of 111 infants were assigned into the high (54) or low (57) dose groups']","['Caffeine citrate maintenance', 'Caffeine citrate', 'caffeine citrate']","['incidence of tachycardia', 'time until failure', 'abdominal distension', 'feeding intolerance', 'duration of invasive ventilation', 'extubation and apnea post-ventilation', 'duration of ventilation before extubation', 'age of extubation', 'irritability', 'duration of nasal continuous positive airway', 'number of days of apnea', 'incidence of extubation failure and apnea of prematurity', 'Extubation failure']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}]",111.0,0.0582797,"Furthermore, no significant differences in the incidence of tachycardia (9.3% vs 12.3%), abdominal distension (16.7% vs 12.3%), feeding intolerance (3.7% vs 5.3%) or irritability (7.4% vs 5.3%) were observed between groups.
","[{'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Pediatrics, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Neonatology, Children's Medical Center, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, Hunan, China.""}, {'ForeName': 'Pingyang', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",Pediatric pulmonology,['10.1002/ppul.24948']
2197,32634486,Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.,"BACKGROUND


Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.
METHODS


This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).
DISCUSSION


AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).",2020,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","['Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups', 'adolescents with type 1 diabetes', 'patients with T1D often receive care in clinics and institutions with limited resources and time', ""middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population""]",[],"['patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0267749,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, United States of America.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ruelas', 'Affiliation': 'Keck School of Medicine, University of Southern California, United States of America.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ashwal', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""The Vision Center, Children's Hospital Los Angeles, United States of America.""}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'School of Pharmacy, University of Southern California, United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClain', 'Affiliation': 'School of Social Work, University of Southern California, United States of America.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Center for Endocrinology, Diabetes, & Metabolism, Children's Hospital Los Angeles, United States of America. Electronic address: jraymond@chla.usc.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106079']
2198,32634642,Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations.,"PURPOSE


This randomized double-blind study aimed to evaluate the effects of dexmedetomidine on hemodynamic parameters and the quality of surgery and recovery criteria in tympanoplasty operations.
MATERIALS AND METHODS


A total of 75 patients 18-55 years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II, were randomly divided into three groups. Group 1 included patients receiving remifentanil alone, Group 2 included patients receiving dexmedetomidine + remifentanil and Group 3 included patients receiving dexmedetomidine + ½ remifentanil. Anesthesia was induced with propofol and cisatracurium. For maintenance of anesthesia, a mixture of 2-2.5% sevoflurane, 40-60% oxygen/air was used. The groups were compared in terms of hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects.
RESULTS


Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3. Surgical field satisfaction was higher in Group 2 and Group 3 than Group 1. Spontaneous breathing, eye opening and verbal cooperation times were shorter in Group 3 compared to Group 2. Eye opening and verbal cooperation times were longer in Group 2 compared to Group 1. The 30-minute modified Aldrete scores was higher in Group 3 compared to Group 1. There was no difference between the groups in terms of postoperative pain and adverse effects.
CONCLUSION


The use of dexmedetomidine during tympanoplasty operations may provide better hemodynamic control and surgical view, may provide faster recovery and may reduce remifentanil consumption.",2020,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","['75 patients 18-55\xa0years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II']","['dexmedetomidine + ½ remifentanil', 'remifentanil alone', 'propofol and cisatracurium', 'sevoflurane', 'dexmedetomidine', 'dexmedetomidine + remifentanil']","['Eye opening and verbal cooperation times', 'Mean arterial pressure and heart rate values', 'Surgical field satisfaction', 'Spontaneous breathing, eye opening and verbal cooperation times', 'postoperative pain and adverse effects', 'hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects', 'tympanoplasty operations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.0542959,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Bengu', 'Initials': 'B', 'LastName': 'Cobanoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Otorhinolaryngology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102619']
2199,32634673,Ulipristal acetate versus gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Long term results of a double-blind randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the effect of ulipristal acetate (UPA) and gonadotropin-releasing hormone agonists (GnRHa) before laparoscopic myomectomy on long term secondary outcomes of the MYOMEX-trial, regarding quality of life, ultrasound characteristics, hemoglobin levels 6 weeks post-operative, sexual function and menstrual bleeding control. A cost-analysis was also performed. Short-term primary and secondary outcomes are reported elsewhere.
STUDY DESIGN


A double-blind, randomized, controlled, non-inferiority trial in nine hospitals in the Netherlands. Participants were randomized in a 1:1 ratio (block size of four, stratified per hospital) to either UPA or GnRHa pre-treatment. Additional placebo injections containing saline, respectively daily placebo tablets were given to both groups to ensure double-blinding. Surgery was performed within a month after the last tablet. Women were followed up until six months post-surgery.
RESULTS


A total of 55 participants were randomized: 30 to the UPA- and 25 to the GnRHa-group between May 2015 and July 2017. Uterine volume at six weeks post-operative did not differ significantly between both pre-treatment groups with 170.1 cm 3  (106.8-243.5; N = 29) vs. 152.8 cm 3  (92.3-205.6; N = 23) for the UPA- and GnRHa-group respectively (p = 0.423). Hemoglobin levels six weeks post-operatively recovered back to baseline and were not significantly different between groups with 7.7 mmol/L for the UPA- vs. 8.1 mmol/L for the GnRHa-group (p = 0.157; mean difference -0.4 (CI -0.9, 0.2). Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups. Symptom severity scores also decreased significantly at 6 week post-operatively compared to baseline, but did not differ between the treatment groups. Fibroid characteristics at baseline (e.g. mean diameter of largest fibroid) appeared not to be a confounding factor. An exploratory cost analysis showed no significant differences in absenteeism costs, total healthcare and societal costs, after adjustment for confounding factors.
CONCLUSION


Pre-treatment prior to laparoscopic myomectomy with UPA compared to GnRHa has similar effects on bleeding pattern, menopausal symptoms, sexual functioning, symptom severity and quality of life from baseline up to six months post-operative. Due to the small sample size, these findings should be interpreted with caution. Also, no firm conclusions on costs could be made.",2020,"Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups.","['prior to laparoscopic myomectomy (MYOMEX trial', 'A total of 55 participants were randomized: 30 to the UPA- and 25 to the GnRHa-group between May 2015 and July 2017', 'nine hospitals in the Netherlands']","['UPA or GnRHa pre-treatment', 'Ulipristal acetate versus gonadotropin-releasing hormone agonists', 'ulipristal acetate (UPA) and gonadotropin-releasing hormone agonists (GnRHa) before laparoscopic myomectomy', 'placebo injections containing saline, respectively daily placebo tablets']","['Fibroid characteristics', 'Hemoglobin levels', 'Menstrual bleeding pattern, quality of life, effects on general and sexual health', 'absenteeism costs, total healthcare and societal costs', 'bleeding pattern, menopausal symptoms, sexual functioning, symptom severity and quality of life', 'Symptom severity scores', 'Uterine volume', 'quality of life, ultrasound characteristics, hemoglobin levels 6 weeks post-operative, sexual function and menstrual bleeding control']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",55.0,0.659859,"Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups.","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'De Milliano', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands.'}, {'ForeName': 'Mei-An', 'Initials': 'MA', 'LastName': 'Middelkoop', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands. Electronic address: m.middelkoop@amsterdamumc.nl.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Kwee', 'Affiliation': 'OLVG, Department of Obstetrics and Gynecology, Jan Tooropstraat 164, Amsterdam, The Netherlands.'}, {'ForeName': 'Peggy M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Máxima Medisch Centrum, Department of Obstetrics and Gynecology, De Run 4600, Veldhoven, The Netherlands.'}, {'ForeName': 'Benedictus C', 'Initials': 'BC', 'LastName': 'Schoot', 'Affiliation': 'Catharina Ziekenhuis, Department of Obstetrics and Gynecology, Michelangelolaan 2, Eindhoven, The Netherlands.'}, {'ForeName': 'Marchien', 'Initials': 'M', 'LastName': 'Van Baal', 'Affiliation': 'Flevoziekenhuis, Department Obstetrics and Gynecology, Hospitaalweg 1, Almere, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter J K', 'Initials': 'WJK', 'LastName': 'Hehenkamp', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands. Electronic address: w.hehenkamp@amsterdamumc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.035']
2200,32636128,Administration of eicosapentaenoic acid may alter lipoprotein particle heterogeneity in statin-treated patients with stable coronary artery disease: A pilot 6-month randomized study.,"BACKGROUND


We hypothesized that the addition of eicosapentaenoic acid (EPA) to ongoing statin therapy could change the particle heterogeneity of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) particles, even in stable coronary artery disease (CAD) patients.
METHODS


We assigned CAD patients already receiving statin therapy to one of two groups: an EPA group (1800 mg/day; n = 30) and a control group (n = 30). A gel permeation high-performance liquid chromatography method was used to measure the particle concentration and number of lipoprotein subclasses.
RESULTS


In the EPA group, significant decreases of both the concentration and number of medium LDL (p = 0.0002 and 0.0001), small LDL (p = 0.0004 and 0.0005) and very small LDL (p = 0.0005 and 0.002) particles were observed. Conversely, the concentration and number of large HDL particles increased significantly (p = 0.024 and 0.048). The concentration of very large HDL particles also increased significantly (p = 0.028). Furthermore, significant correlations between the variables that showed significant changes in the LDL and HDL particle subclasses, and the EPA/arachidonic acid (AA) ratio were found. No other significant associations of lipoprotein particle heterogeneity with the serum EPA/AA ratio were noted in either the control group or the EPA group. Interestingly, univariate and multivariate regression analyses revealed that increased serum lecithin-cholesterol acyltransferase activity, a key enzyme of HDL cholesterol efflux, was a predictor for increased above-mentioned HDL particles subclasses.
CONCLUSIONS


Administration of EPA might alter both LDL and HDL particle heterogeneity, causing decreased concentration and number of smaller LDL particles and increased concentration and number of larger HDL particles. Furthermore, addition of EPA to ongoing statin therapy appears to be capable of increasing the EPA/AA ratio, which might have an anti-atherosclerotic effect on lipoprotein particle heterogeneity, even in stable CAD patients with well-controlled serum lipid levels.
CLINICAL TRIAL REGISTRATION


UMIN (http://www.umin.ac.jp/) Study ID: UMIN000010452.",2020,"In the EPA group, significant decreases of both the concentration and number of medium LDL (p = 0.0002 and 0.0001), small LDL (p = 0.0004 and 0.0005) and very small LDL (p = 0.0005 and 0.002) particles were observed.","['stable coronary artery disease (CAD) patients', 'statin-treated patients with stable coronary artery disease']","['eicosapentaenoic acid', 'EPA', 'eicosapentaenoic acid (EPA', 'statin therapy']","['concentration and number of large HDL particles', 'concentration and number of larger HDL particles', 'concentration of very large HDL particles', 'lipoprotein particle heterogeneity with the serum EPA/AA ratio', 'small LDL', 'lipoprotein particle heterogeneity', 'concentration and number of medium LDL', 'LDL and HDL particle subclasses, and the EPA/arachidonic acid (AA) ratio', 'serum lecithin-cholesterol acyltransferase activity, a key enzyme of HDL cholesterol efflux', 'low-density lipoprotein (LDL) and high-density lipoprotein (HDL) particles']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0450093', 'cui_str': 'Very large'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0023194', 'cui_str': 'Phosphatidylcholine-sterol acyltransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.0653798,"In the EPA group, significant decreases of both the concentration and number of medium LDL (p = 0.0002 and 0.0001), small LDL (p = 0.0004 and 0.0005) and very small LDL (p = 0.0005 and 0.002) particles were observed.","[{'ForeName': 'Shigemasa', 'Initials': 'S', 'LastName': 'Tani', 'Affiliation': 'Department of Health Planning Center, Nihon University Hospital, Tokyo Japan; Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan. Electronic address: tani.shigemasa@nihon-u.ac.jp.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Yagi', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Matsuo', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kawauchi', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Atsumi', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.06.006']
2201,32639235,"Bimodal Release Ondansetron Improves Stool Consistency and Symptomatology in Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Trial.","INTRODUCTION


Previous, small studies have suggested that ondansetron has beneficial effects in diarrhea-predominant irritable bowel syndrome (IBS-D). This randomized, double-blind study evaluated the efficacy and safety of daily 12 mg RHB-102, an investigational bimodal release ondansetron tablet, in IBS-D.
METHODS


Men and women with IBS-D by the Rome III criteria, Bristol Stool Scale ≥6 on 2 or more days weekly, and average daily worst pain intensity ≥3/10 were randomized 60:40 to RHB-102 or placebo once daily for 8 weeks. The primary end point was overall stool consistency response for at least 4 of 8 weeks. Secondary end points included overall worst abdominal pain and overall composite response, defined as response on both abdominal pain and stool consistency end points.
RESULTS


Overall stool consistency response rates were 56.0% and 35.3% (RHB-102 vs placebo, P = 0.036) and similar among male and female patients. Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant. Stool consistency response rates were enhanced in patients with baseline C-reactive protein above the median (2.09 mg/L), 59.5%, vs 23.1% (P = 0.009). Overall rates of adverse events were similar, with a higher rate of constipation in RHB-102 patients (13.3% vs 3.9%) that resolved rapidly on withholding treatment.
DISCUSSION


RHB-102 was effective and safe in the treatment of men and women with IBS-D. Baseline C-reactive protein seemed to be predictive of response.",2020,"Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant.","['Men and women with IBS-D by the Rome III criteria, Bristol Stool Scale ≥6 on 2 or more days weekly, and average daily worst pain intensity ≥3/10', 'Diarrhea-Predominant Irritable Bowel Syndrome']","['RHB-102', 'RHB-102 or placebo', 'Bimodal Release Ondansetron', 'daily 12 mg RHB-102', 'ondansetron']","['Stool consistency response rates', 'Stool Consistency and Symptomatology', 'effective and safe', 'rate of constipation', 'Overall pain response', 'efficacy and safety', 'overall worst abdominal pain and overall composite response, defined as response on both abdominal pain and stool consistency end points', 'composite response rates', 'Overall rates of adverse events', 'overall stool consistency response', 'Overall stool consistency response rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.720687,"Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant.","[{'ForeName': 'Terry F', 'Initials': 'TF', 'LastName': 'Plasse', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Arkansas Gastroenterology, PA, North Little Rock Arkansas, USA.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'New Phase Research & Development, Knoxville, Tennessee, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Abramson', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Kalfus', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fathi', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Gilead', 'Initials': 'G', 'LastName': 'Raday', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Harris', 'Affiliation': 'Middleburg Consultants, Takoma Park, Maryland, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000727']
2202,32641079,Association between recipient survival and blood donor age after blood transfusion in a surgery intensive care unit: a multicenter randomized controlled trial study protocol.,"BACKGROUND


Blood from younger individuals has been shown to improve physiological function in recipients in laboratory research, and many proteins from human peripheral blood show antisenescence capabilities. Thus, researchers have questioned whether blood from young donors is superior to blood from older donors. Blood transfusion is a key supportive therapy for trauma patients, and recent studies have reported the influence of blood donor age on recipient patient prognosis. Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups. The reasons for this discrepancy are complicated, but the fact that data were not obtained from randomized controlled trial (RCT) data should be considered. The current protocol and analysis method provide a feasible RCT design to evaluate the prognosis of severely ill surgery patients who were transfused with blood products from blood donors of different ages.
METHODS


The current study is a pragmatic multicenter RCT (open, parallel-group, non-masked, superiority trial). Recruited surgery intensive care unit patients will be randomized into three groups and transfused with blood products from male donors of different ages (< 25, 25-45, and > 45 years). Survival time will be measured within 28 days. The survival characteristics, possible interaction between variables, and potential factors associated with death will be analyzed by Kaplan-Meier analysis, two-way ANOVA, and Cox proportional hazards model, respectively.
TRIAL REGISTRATION


ChiCTR: ChiCTR190002. Registered on 22 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36867 .",2020,"Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups.","['trauma patients', 'from male donors of different ages (<\u200925, 25-45, and\u2009>\u200945\u2009years', 'Recruited surgery intensive care unit patients', 'severely ill surgery patients who were transfused with blood products from blood donors of different ages']",['transfused with blood products'],"['Survival time', 'survival']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}]","[{'cui': 'C0456388', 'cui_str': 'Blood product'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.182186,"Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups.","[{'ForeName': 'Xianfei', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': ""School of Medicine, Northwest University, Xi'an, 710069, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Transfusion Medicine, Third Affiliated Hospital of Guangxi Medical University, Nanning, 530031, China.'}, {'ForeName': 'Xiaoshuang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Chenxing', 'Initials': 'C', 'LastName': 'Da', 'Affiliation': ""Department of Endocrinology, Shaanxi Corps Hospital, Chinese People's Armed Police Forces, Xi'an, 710054, China.""}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Statistics, Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': ""Department of Digestive Surgery, Xijing Hospital, Xi'an, 710032, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Dongjian', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Transfusion Medicine, 908th Hospital of PLA, Yingtan, 335000, China. dearwdj@163.com.'}, {'ForeName': 'Xingbin', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China. hxbyqh@163.com.""}]",Trials,['10.1186/s13063-020-04452-6']
2203,32641081,Effect of preoperative immunonutrition on outcomes of colon cancer surgery: study protocol for a randomized controlled trial.,"BACKGROUND


Current guidelines recommend the prescription of immune-enriched oral nutritional supplements for malnourished patients before major gastrointestinal surgery. However, the benefit of preoperative immunonutrition is still controversial. This randomized controlled trial aims to evaluate the effect of preoperative immunonutrition on the outcomes of surgery for colon cancer.
METHODS/DESIGN


Patients with primary colon cancer will be included as study participants after screening. They will be randomly assigned (in a ratio of 1:1) to receive preoperative immunonutrition added to the normal diet (experimental arm) or consume normal diet alone (control arm). Patients in the experimental arm will receive oral supplementation (400 mL/day) with arginine and ω-3 fatty acids for 7 days before elective surgery. The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome. The authors hypothesize that the rate of infectious complications would be 13% in the experimental arm and 30% in the control arm. With a two-sided alpha of 0.05 and a power of 0.8, the sample size is calculated as 176 patients (88 per arm).
DISCUSSION


Although there have been many studies demonstrating significant benefits of preoperative immunonutrition, these were limited by a small sample size and potential publication bias. Despite the recommendation of immunonutrition before surgery in nutritional guidelines, its role in reduction of rate of infectious complications is still controversial. This trial is expected to provide evidence for the benefits of administration of preoperative immunonutrition in patients with colon cancer.
TRIAL REGISTRATION


Clinical Research Information Service KCT0003770 . Registered on 15 April 2019.",2020,"The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome.","['colon cancer surgery', 'Patients with primary colon cancer will be included as study participants after screening', '176 patients (88 per arm', 'malnourished patients before major gastrointestinal surgery', 'patients with colon cancer']","['oral supplementation', 'arginine and ω-3 fatty acids', 'preoperative immunonutrition added to the normal diet (experimental arm) or consume normal diet alone (control arm', 'preoperative immunonutrition']","['postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome', 'rate of infectious complications']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.261072,"The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome.","[{'ForeName': 'Soo Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Seung-Seop', 'Initials': 'SS', 'LastName': 'Yeom', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Chang Hyun', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Hyeong Rok', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea. drkhr@jnu.ac.kr.'}]",Trials,['10.1186/s13063-020-04544-3']
2204,32641090,Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial.,"BACKGROUND


With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible quality of cardiopulmonary resuscitation (CPR) and chest compressions (CC). It is essential to minimize CC interruptions, and therefore increase the chest compression fraction (CCF), as this is an independent factor for survival. Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause. CC guidance improves adherence to recommendations and allows closer alignment with the CC objectives. The possibility of improving CCF by lengthening the time between two CC relays and the effect of real-time feedback on the quality of the CC must be investigated.
METHODS


Using a 2 × 2 factorial design in a multicenter randomized trial, two hypotheses will be tested simultaneously: (i) a 4-min relay rhythm improves the CCF (reducing the no-flow time) compared to the currently recommended 2-min relay rate, and (ii) a guiding tool improves the quality of CC. Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device. Five hundred adult nontraumatic OHCAs will be included over 2 years. Patients will be randomized in a 1:1:1:1 distribution receiving advanced CPR as follows: 2-min blind, 2 min with guidance, 4-min blind, or 4 min with guidance. Secondary outcomes are the depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3.
DISCUSSION


This study will contribute to assessing the impact of real-time feedback on CC quality in practical conditions of OHCA resuscitation. It will also provide insight into the feasibility of extending the relay rhythm between two rescuers from the currently recommended 2 to 4 min.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03817892 . Registered on 28 January 2019.",2020,"Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause.","['Five hundred adult nontraumatic OHCAs', 'out-of-hospital cardiac arrest']","['chest compression cycle length and real-time feedback with a CPRmeter®', 'CC guidance']","['chest compression quality', 'suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause', 'Survival', 'Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device', 'depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3', 'survival rate']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",2.0,0.0745678,"Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause.","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Buléon', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France. buleon-c@chu-caen.fr.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Unité de Biostatistiques et de Recherche Clinique, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Morilland-Lecoq', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Unité de Biostatistiques et de Recherche Clinique, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Halbout', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cesaréo', 'Affiliation': 'Department of Emergency Medicine, SAMU 69, Hospital Edouard Herriot, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Dubien', 'Affiliation': 'Department of Emergency Medicine, SAMU 69, Hospital Edouard Herriot, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Jardel', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, SAMU 76, Rouen University Hospital, Rouen Cedex, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boyer', 'Affiliation': 'SAMU Amiens, CHU Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Husson', 'Affiliation': 'Emergency Medicine Department and SAMU 59, Lille University Hospital, Lille, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Andriamirado', 'Affiliation': ""Emergency Department, Centre Hospitalier d'Evreux, Evreux, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Benet', 'Affiliation': 'Emergency Department, Centre Hospitalier du Havre, Le Havre, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morel-Marechal', 'Affiliation': ""Emergency Department, Centre Hospitalier d'Elbeuf Louviers Val-de-Reuil, Elbeuf, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Aubrion', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Muntean', 'Affiliation': 'Emergency Department, Centre Hospitalier de Cherbourg, Cherbourg, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Dupire', 'Affiliation': 'Emergency Department, Centre Hospitalier de Valenciennes, Valenciennes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roupie', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Hubert', 'Affiliation': 'University Lille, EA 2694 - Santé Publique: Épidémiologie et Qualité des Soins, F-59000, Lille, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vilhelm', 'Affiliation': 'University Lille, EA 2694 - Santé Publique: Épidémiologie et Qualité des Soins, F-59000, Lille, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Gueugniaud', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, SAMU 76, Rouen University Hospital, Rouen Cedex, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04536-3']
2205,32641091,"Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study.","BACKGROUND


The outbreak of COVID-19 (caused by SARS-Cov-2) is very serious, and no effective antiviral treatment has yet been confirmed. The adage ""old drug, new trick"" in this context may suggest the important therapeutic potential of existing drugs. We found that the lopinavir/ritonavir treatment recommended in the fifth edition of the Treatment Plan of China can only help to improve a minority of throat-swab nucleic-acid results (3/15) in hospitals. Our previous use of chloroquine to treat patients with COVID-19 infection showed an improvement in more throat-swab nucleic-acid results (5/10) than the use of lopinavir/ritonavir.
METHODS/DESIGN


This is a prospective, open-label, randomized controlled, multicenter clinical study. The study consists of three phases: a screening period, a treatment period of no more than 10 days, and a follow-up period for each participant. Participants with COVID-19 infection who are eligible for selection for the study will be randomly allocated to the trial group or the control group. The control group will be given lopinavir/ritonavir treatment for no more than 10 days. The trial group will be given chloroquine phosphate treatment for no more than 10 days. The primary outcome is the clinical recovery time at no more than 28 days after the completion of therapy and follow-up. The secondary outcomes include the rate of treatment success after the completion of therapy and follow-up, the time of treatment success after no more than 28 days, the rate of serious adverse events during the completion of therapy and follow-up, and the time to return to normal temperature (calculated from the onset of illness) during the completion of therapy and follow-up. Comparisons will be performed using two-sided tests with a statistical significance level of 5%.
DISCUSSION


This experiment should reveal the efficacy and safety of using chloroquine versus lopinavir/ritonavir for patients with mild/general COVID-19 infection. If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ID: ChiCTR2000029741 . Registered on 11 February 2020.",2020,"If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.
","['patients with mild/general COVID-19 infection', 'Participants with COVID-19 infection who are eligible for selection for the study', 'mild/general COVID-19 infection']","['lopinavir/ritonavir', 'chloroquine', 'chloroquine phosphate', 'chloroquine versus lopinavir/ritonavir']","['clinical recovery time', 'time to return to normal temperature', 'rate of treatment success after the completion of therapy and follow-up, the time of treatment success', 'efficacy and safety', 'rate of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0055447', 'cui_str': 'Chloroquine phosphate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0231262', 'cui_str': 'Temperature normal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0816284,"If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Shang', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Hongqiong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Gongqi', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Yuanli', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Hospital Infection Control, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Shaoxuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Office of Clinical Research Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Yaoyong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Mingxing', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. huangmx5@mail.sysu.edu.cn.'}, {'ForeName': 'Zhongsi', 'Initials': 'Z', 'LastName': 'Hong', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. hongzhs@sysu.edu.cn.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. xiajinyu@mail.sysu.edu.cn.'}]",Trials,['10.1186/s13063-020-04478-w']
2206,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
2207,32641291,Combining parenting and economic strengthening programmes to reduce violence against children: a cluster randomised controlled trial with predominantly male caregivers in rural Tanzania.,"INTRODUCTION


Parenting programmes may reduce the risk of violence against children and improve child well-being. However, additional economic support may be necessary in highly deprived rural communities in sub-Saharan Africa. Furthermore, delivering programmes within farmer groups may increase male caregiver recruitment and engagement.
METHODS


A parallel cluster randomised controlled trial examined the combined and separate effects of parenting and economic strengthening programmes on reducing violence against children aged 0-18 years in farming communities in Tanzania (n=248 families; 63% male caregivers). Eight villages were randomly assigned to four conditions (2:2:2:2): (1) 12-session parenting programme (n=60); (2) agribusiness training (n=56); (3) parenting and agribusiness combined (n=72); (4) control (n=60). Parent-report, child-report and early childhood observation assessments were conducted at baseline, mid-treatment and post-treatment. Primary outcomes were child maltreatment and parenting behaviour. Secondary outcomes included corporal punishment endorsement, parenting stress, parent/child depression, child behaviour, economic well-being and child development.
RESULTS


At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92). Parents reported reduced endorsement of corporal punishment ( D w  =-0.43, 95% CI -0.79 to 0.07) and fewer child behaviour problems ( D w  =-0.41, 95% CI -0.77 to 0.05). Parents in parenting-only villages reported less abuse (IRR=0.36, 95% CI 0.21 to 0.63) and fewer child behaviour problems ( D w  =-0.47, 95% CI -0.84 to 0.11). Parents in agribusiness-only villages reported fewer child behaviour problems ( D w  =-0.43, 95% CI -0.77 to 0.08) and greater household wealth ( D w  =0.57, 95% CI 0.08 to 1.06). However, children in agribusiness-only villages reported increased physical abuse (IRR=2.26, 95% CI 1.00 to 5.12) and less positive parenting ( D w  =-0.50, 95% CI -0.91 to 0.10). There were no other adverse effects.
CONCLUSION


Parent training may be the active ingredient in reducing maltreatment in farmer groups with majority male caregivers, while agribusiness training programmes may have unintended negative consequences on children when delivered alone. Locating parenting support in existing farmer groups can engage much higher proportions of fathers than stand-alone programmes.ClinicalTrials.gov: NCT02633319.",2020,"At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92).","['violence against children aged 0-18 years in farming communities in Tanzania (n=248 families; 63% male caregivers', 'Eight villages', 'predominantly male caregivers in rural Tanzania', 'farmer groups with majority male caregivers', 'violence against children']","['agribusiness training (n=56); (3) parenting and agribusiness combined', 'Combining parenting and economic strengthening programmes', 'parenting and economic strengthening programmes', '12-session parenting programme']","['greater household wealth', 'child maltreatment and parenting behaviour', 'incidence rate ratio', 'corporal punishment endorsement, parenting stress, parent/child depression, child behaviour, economic well-being and child development', 'child behaviour problems', 'positive parenting', 'physical abuse', 'endorsement of corporal punishment', 'adverse effects']","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0474413', 'cui_str': 'Problematic behavior in children'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",8.0,0.282938,"At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92).","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Lachman', 'Affiliation': 'Department of Social Policy and Intervention, University of Oxford, Oxford, UK jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Wamoyi', 'Affiliation': 'National Institute for Medical Research Mwanza Research Centre, Mwanza, Mwanza, United Republic of Tanzania.'}, {'ForeName': 'Thees', 'Initials': 'T', 'LastName': 'Spreckelsen', 'Affiliation': 'School of Social and Political Sciences, University of Glasgow, Glasgow, Glasgow, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wight', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Maganga', 'Affiliation': 'National Institute for Medical Research Mwanza Research Centre, Mwanza, Mwanza, United Republic of Tanzania.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Department of Social Policy and Intervention, University of Oxford, Oxford, UK.'}]",BMJ global health,['10.1136/bmjgh-2020-002349']
2208,32657060,Effects of Evening Exposure to Light from Organic Light-Emitting Diodes on Melatonin and Sleep.,"BACKGROUND AND PURPOSE


Organic light-emitting diodes (OLEDs) emit less blue light than traditional light-emitting diodes (LEDs), but the effects of OLED light exposure (LE) on melatonin and sleep have not been evaluated.
METHODS


Twenty-four healthy subjects (age 26.9±5.7 years; including 18 females) with the intermediate chronotype were exposed to three different light conditions [4,000 K 150 lux OLED LE, 4,000 K 150 lux LED LE, and dim light (DL) at <10 lux] for 6.5 h from 17:30 to 24:00, in a random order and with a 1-week interval. Participants entered the unit for the experiment at 16:00, and their daylight was measured by actigraphy from 8:00 to 16:00 during each session. Saliva samples for melatonin were taken every hour from 18:00 to 24:00. Sleep was monitored by polysomnography, and vigilance was evaluated by psychomotor vigilance test upon awakening.
RESULTS


Melatonin onset occurred at 21:11±01:24, 21:20±01:19, and 21:36±01:16 in the DL, OLED, and LED conditions, respectively. Melatonin onset was significantly delayed under LED LE compared to DL ( p =0.007) but did not differ under OLED LE ( p =0.245). Melatonin suppression, sleep parameters, and vigilance were similar among the three light conditions. The accumulated amount of daytime light in each session was negatively correlated with the melatonin onset time under the DL (rho=-0.634,  p =0.002) and OLED (rho=-0.447,  p =0.029) conditions, not under the LED condition ( p =0.129).
CONCLUSIONS


Melatonin onset under OLED LE was not significantly delayed compared to DL. Exposure to sufficient daylight may advance melatonin onset even when a subject is exposed to OLED LE in the evening.",2020,Melatonin onset was significantly delayed under LED LE compared to DL ( p =0.007) but did not differ under OLED LE ( p =0.245).,['Twenty-four healthy subjects (age 26.9±5.7 years; including 18 females) with the intermediate chronotype'],[],"['Melatonin onset was significantly delayed under LED LE', 'Melatonin and Sleep', 'Melatonin onset', 'melatonin onset time under the DL', 'OLED', 'Melatonin suppression, sleep parameters, and vigilance', 'Sleep']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]",[],"[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}]",4000.0,0.0378351,Melatonin onset was significantly delayed under LED LE compared to DL ( p =0.007) but did not differ under OLED LE ( p =0.245).,"[{'ForeName': 'Hea Ree', 'Initials': 'HR', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Inje University College of Medicine, Ilsan Paik Hospital, Goyang, Korea.'}, {'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Department of Nursing, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Hyunjin', 'Initials': 'H', 'LastName': 'Jo', 'Affiliation': 'Department of Neurology, Neuroscience Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Wook', 'Initials': 'JW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Eun Yeon', 'Initials': 'EY', 'LastName': 'Joo', 'Affiliation': 'Department of Neurology, Neuroscience Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. ejoo@skku.edu.'}]","Journal of clinical neurology (Seoul, Korea)",['10.3988/jcn.2020.16.3.401']
2209,32657194,Personality traits as predictors of exercise treatment adherence in major depressive disorder: lessons from a randomised clinical trial.,"OBJECTIVE


The objective of this study was to explore the determinants of adherence in the EFFORT-D (EFFect Of Running Therapy) study in a specialised mental health care hospital setting.
METHODS


Patients with major depressive disorder (MDD) were given treatment as usual and half were randomised to an exercise intervention. Adherence was measured at 3 months (T3) and 6 months (T6) and was defined as participation in the overall study protocol (total  n  = 42, adhered  n  = 28) or intervention (total  n  = 24, adhered  n  = 9). Potential determinants were age, BMI, tobacco and alcohol use, severity of depression, anxiety, fitness (VO 2 max kg -1  and Wmax kg -1 ) and personality traits at baseline. ANOVA, Chi-square tests and block-wise logistic regression were performed, and reliability of the scales was determined.
RESULTS


Numbers were found too low for analyses on smoking, drinking and anxiety. Higher agreeableness was significantly associated with better adherence to the overall study protocol (OR 1.2;  p  = 0.03; 95% CI: 1.01-1.4) and severity of depression was negatively associated with adherence in the intervention group (OR 0.70;  p  = 0.046;95% CI: 0.49-0.99).
CONCLUSIONS


To adhere to a study protocol involving exercise or to a clinical exercise programme, MDD patients need substantial personal support. Measurement of personality traits and the severity of depression as potential predictors of adherence could be considered for this purpose. Keypoints Adherence to exercise and study protocols in a randomised controlled trial was low Patients with severe major depressive disorder need substantial personal support Measurement of personality traits could be considered.",2020,"Higher agreeableness was significantly associated with better adherence to the overall study protocol (OR 1.2;  p  = 0.03; 95% CI: 1.01-1.4) and severity of depression was negatively associated with adherence in the intervention group (OR 0.70;  p  = 0.046;95% CI: 0.49-0.99).
","['Patients with major depressive disorder (MDD', 'low Patients with severe major depressive disorder need substantial personal support Measurement of personality traits', 'major depressive disorder']",['exercise intervention'],"['BMI, tobacco and alcohol use, severity of depression, anxiety, fitness (VO 2 max\xa0kg -1  and Wmax\xa0kg -1 ) and personality traits', 'severity of depression', 'smoking, drinking and anxiety', 'Adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.115228,"Higher agreeableness was significantly associated with better adherence to the overall study protocol (OR 1.2;  p  = 0.03; 95% CI: 1.01-1.4) and severity of depression was negatively associated with adherence in the intervention group (OR 0.70;  p  = 0.046;95% CI: 0.49-0.99).
","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kruisdijk', 'Affiliation': 'GGz Centraal Innova, Amersfoort, The Netherlands.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Hopman-Rock', 'Affiliation': 'Body@Work, TNO-VU University Amsterdam Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingrid J M', 'Initials': 'IJM', 'LastName': 'Hendriksen', 'Affiliation': 'Body@Work, TNO-VU University Amsterdam Medical Center, Amsterdam, The Netherlands.'}]",International journal of psychiatry in clinical practice,['10.1080/13651501.2020.1787452']
2210,32657195,Improved adenoma detection with linked color imaging technology compared to white-light colonoscopy.,"OBJECTIVES


Linked color imaging (LCI) is a new endoscopic technology that may increase colorectal adenoma detection rate (ADR) and polyp detection rate (PDR) by virtual chromoendoscopy. Aim of the present study was to evaluate the effectiveness of LCI in ADR and PDR compared to the HD white-light colonoscopy (WLC) technique.
MATERIALS AND METHODS


Between October 2016 and June 2018, we enrolled consecutive outpatients prospectively. Eligible patients allocated randomly to undergo HD WLC or LCI colonoscopy technique during instrument withdrawal. Each colonoscopy was performed in a single center by the same three expert endoscopists (with expertise more than 5000 colonoscopies).
RESULTS


A total of 1278 patients underwent colonoscopy in the study period. ADR and PDR were significantly higher in the LCI group compared to the WLC group (34.4% vs. 26.8%;  p  = .007; and 53.3% vs 46.4%;  p  = .023, respectively). Similarly, the mean number of adenomas per patient (MAP) was significantly higher with the LCI than WLC (0.64 vs 0.44, respectively;  p  = .002). The mean age of patients at the time of colonoscopy was 51.95 years (SD = 13.861) in the LCI group and 51.96 years (SD = 14.028) in the WLC group. No significant differences observed in patient demographic characteristics (there was no difference in gender and age distribution,  p  = .986), quality of colonoscopy preparation and withdrawal times (WT) between the two groups (WLC and the LCI groups, 493.9 (SD: 143.5) and 514.0 (SD: 139.5) sec, respectively).
CONCLUSIONS


According to our results, LCI virtual chromoendoscopic technology was superior compared to conventional HD WLC in detecting colorectal polyps and adenomas.",2020,"No significant differences observed in patient demographic characteristics (there was no difference in gender and age distribution,  p  = .986), quality of colonoscopy preparation and withdrawal times (WT) between the two groups (WLC and the LCI groups, 493.9 (SD: 143.5) and 514.0 (SD: 139.5) sec, respectively).
","['Between October 2016 and June 2018, we enrolled consecutive outpatients prospectively', '1278 patients underwent colonoscopy in the study period']","['HD white-light colonoscopy (WLC) technique', 'LCI', 'conventional HD WLC', 'HD WLC or LCI colonoscopy technique', 'Linked color imaging (LCI', 'WLC']","['patient demographic characteristics', 'colorectal adenoma detection rate (ADR) and polyp detection rate (PDR', 'quality of colonoscopy preparation and withdrawal times (WT', 'ADR and PDR', 'mean number of adenomas per patient (MAP']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",1278.0,0.0214043,"No significant differences observed in patient demographic characteristics (there was no difference in gender and age distribution,  p  = .986), quality of colonoscopy preparation and withdrawal times (WT) between the two groups (WLC and the LCI groups, 493.9 (SD: 143.5) and 514.0 (SD: 139.5) sec, respectively).
","[{'ForeName': 'Barbara Dorottya', 'Initials': 'BD', 'LastName': 'Lovász', 'Affiliation': 'Institute of Applied Health Sciences, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Milán', 'Initials': 'M', 'LastName': 'Szalai', 'Affiliation': 'Endoscopy Unit, Endo-Kapszula Health Centre, Székesfehérvár, Hungary.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Oczella', 'Affiliation': 'Institute of Applied Health Sciences, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Ádám', 'Initials': 'Á', 'LastName': 'Finta', 'Affiliation': 'Endoscopy Unit, Endo-Kapszula Health Centre, Székesfehérvár, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Dubravcsik', 'Affiliation': 'Department of Gastroenterology, OMCH Endoscopy Unit, Bács-Kiskun County Hospital, Kecskemét, Hungary.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Madácsy', 'Affiliation': 'Endoscopy Unit, Endo-Kapszula Health Centre, Székesfehérvár, Hungary.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1786850']
2211,32657198,Reliability of the Therapy Behavior Scale version 2.2 in infants with congenital muscular torticollis: A pilot study.,"BACKGROUND


The Therapy Behavior Scale (TBS) is a standardized instrument that is used to evaluate behavior of infants and toddlers during physical, occupational, and developmental therapy sessions. The TBS can be applied in intervention comparison research to assess therapy-related behaviors exhibited by study participants.
PURPOSE


The purpose of this pilot study was to establish the reliability of the TBS Version 2.2 prior to its use in a randomized clinical trial comparing two physical therapy (PT) interventions in infants with congenital muscular torticollis (CMT).
METHODS


Three infants with right and 7 with left CMT, severity grades 1-3, 3 girls and 7 boys, age range 3-6 months, participated in this research. Examiners were 2 experienced pediatric physical therapists. To obtain the intrarater reliability estimates, each examiner conducted 2 PT sessions with 5 infants and scored their behavior ""live,"" and then scored the video recordings of these 10 sessions at least 1 month later. To obtain the interrater reliability estimates, both examiners scored a total of 20 video recordings.
RESULTS


Results indicated good intrarater reliability, with ICC  (3,1)  of 0.92, 95% CI = 0.81-0.99, and 0.95, 95% CI = 73-0.98, and moderate to good interrater reliability, with ICC  (2,1)  of 0.84, 95% CI = 0.48-0.96, and 0.91, 95% CI = 0.67-0.98.
CONCLUSION


This study established the reliability of the TBS Version 2.2 for 2 examiners who subsequently used it in a RCT of 2 PT interventions. Further research is necessary to demonstrate the reliability of this instrument in a larger population of infants with CMT, and in infants and toddlers with other conditions.",2020,"RESULTS


Results indicated good intrarater reliability, with ICC  (3,1)  of 0.92, 95% CI = 0.81-0.99, and 0.95, 95% CI = 73-0.98, and moderate to good interrater reliability, with ICC  (2,1)  of 0.84, 95% CI = 0.48-0.96, and 0.91, 95% CI = 0.67-0.98.
CONCLUSION


","['infants with congenital muscular torticollis', 'Three infants with right and 7 with left CMT, severity grades 1-3, 3 girls and 7 boys, age range 3-6\xa0months, participated in this research', 'infants with congenital muscular torticollis (CMT']","['physical therapy (PT) interventions', 'TBS']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",[],3.0,0.0233261,"RESULTS


Results indicated good intrarater reliability, with ICC  (3,1)  of 0.92, 95% CI = 0.81-0.99, and 0.95, 95% CI = 73-0.98, and moderate to good interrater reliability, with ICC  (2,1)  of 0.84, 95% CI = 0.48-0.96, and 0.91, 95% CI = 0.67-0.98.
CONCLUSION


","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rahlin', 'Affiliation': 'Department of Physical Therapy, Rosalind Franklin University of Medicine and Science , North Chicago, IL, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Haney', 'Affiliation': ""Physical Therapy Department, Rady Children's Hospital San Diego , San Diego, CA, USA.""}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Barnett', 'Affiliation': 'Ability Occupational Therapy Services, LLC , Anchorage, AK, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1786870']
2212,32657611,Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer.,"This study aimed to compare the efficacy and safety of the EC-T (4 cycles of epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2, followed by 4 cycles of docetaxel 75 mg/m2) and TCb (6 cycles of docetaxel 75 mg/m2, intravenous drip (ID), day 1+carboplatin AUC 6, ID, day 1) neoadjuvant regimens in patients with TOP2A-normal stage II-III breast cancer. This study analyzed 280 patients enrolled from three studies registered with ClinicalTrials.gov (NCT03140553, NCT03154749, NCT03507465) with early TOP2A-normal stage II-III breast cancer who received neoadjuvant chemotherapy, including 100 patients who received the EC-T regimen and 180 patients who received the TCb regimen. The primary endpoint was the ratio of RCB 0/1 (residual cancer burden 0/1) after neoadjuvant chemotherapy. The secondary endpoint was the safety of the two groups. There was no significant difference in the ratio of RCB 0/1 between the two groups (23% vs. 23.9%, p = 0.614). Among the triple-negative breast cancer patients, the efficacy did not differ between the two groups (40% vs. 32%, p = 0.52). Among the lymph node metastasis patients, the efficacy of the EC-T group was significantly better than that of the TCb group (14% vs. 2.6%, p = 0.03). Regarding the side effects, the incidence of grade 3/4 anemia was higher in the EC-T group than in the TCb group (21.0% vs. 8.33%, p = 0.002), while the incidence of grade 3/4 neutropenia was higher in the EC-T group than in the TCb group (17% vs. 14.44%, p = 0.570), and the incidence of grade 3/4 thrombocytopenia was low in each group (EC-T group:6 % and TCb group: 7.22%, p = 0.697). In the EC-T group, grade 3/4 nausea and vomiting occurred in 5 patients. The EC-T group showed a higher rate of grade 3/4 myalgia pain than the TCb group (7% and 4.44%, respectively, p = 0.363). To conclude, the TCb regimen can be used as an alternative regimen for TOP2A-normal stage II-III breast cancer patients in neoadjuvant chemotherapy. However, in patients with node-positive tumors, EC-T is still recommended. Though no difference of grade 3/4 thrombocytopenia in two groups, grade 4 thrombocytopenia caused by the carboplatin-containing regimen should be taken seriously.",2020,"The EC-T group showed a higher rate of grade 3/4 myalgia pain than the TCb group (7% and 4.44%, respectively, p = 0.363).","['280 patients enrolled from three studies registered with ClinicalTrials.gov (NCT03140553, NCT03154749, NCT03507465) with early TOP2A-normal stage II-III breast cancer who received neoadjuvant chemotherapy, including 100 patients who received the', 'TOP2A-normal stage II-III breast cancer patients in neoadjuvant chemotherapy', 'early TOP2A-normal stage II-III breast cancer', 'patients with TOP2A-normal stage II-III breast cancer', 'and 180 patients who received the TCb regimen']","['EC-T (4 cycles of epirubicin 90 mg/m2 + cyclophosphamide', 'docetaxel', 'EC-T regimen', 'TCb', 'EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens', 'docetaxel 75 mg/m2) and TCb']","['ratio of RCB', 'incidence of grade 3/4 neutropenia', 'rate of grade 3/4 myalgia pain', 'incidence of grade 3/4 anemia', 'grade 3/4 thrombocytopenia', 'efficacy and safety', 'ratio of RCB 0/1 (residual cancer burden 0/1', 'efficacy', 'grade 4 thrombocytopenia', 'grade 3/4 nausea and vomiting', 'incidence of grade 3/4 thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0256022', 'cui_str': 'Topoisomerase II alpha'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",280.0,0.0453079,"The EC-T group showed a higher rate of grade 3/4 myalgia pain than the TCb group (7% and 4.44%, respectively, p = 0.363).","[{'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Li', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Hu', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'H F', 'Initials': 'HF', 'LastName': 'Gao', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'C Q', 'Initials': 'CQ', 'LastName': 'Yang', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Cheng', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Xu', 'Affiliation': ""Department of Pathology, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}]",Neoplasma,['10.4149/neo_2020_200130N96']
2213,32657613,Third-line treatment for metastatic colorectal cancer: anlotinib is superior to chemotherapy and similar to fruquintinib or regorafenib.,"The clinical efficiency and adverse reactions of anlotinib in metastatic colorectal cancer (mCRC) as a third-line treatment compared with chemotherapy and regorafenib or fruquintinib was explored in this study. Clinical data from 105 mCRC patients who failed at least two lines of chemotherapy were collected. The patients were divided into three groups based on their third-line therapeutic regimen: third-line chemotherapy only (group A); anlotinib (group B); and fruquintinib or regorafenib (group C). The result showed that the ORR and DCR of group B (14.29%, 85.71%) were higher than those of group A (0%, 40.00%). The ORRs of group B and group C were 14.29% and 20.00%, respectively. Group B and group C had the same DCR, 85.71%. The mean PFS values of group B (3.46 months) and group C (3.33 months) were longer than that of group A (2.25 months) (χ2 = 84.255, P < 0.001) and the mean PFS values of group B and group C were similar (χ2 = 0.884, P = 0.347). The mean OS of group B was 9.22 months, which was longer than that of group A (6.95 months) (χ2 = 38.837, P < 0.001). The mean OS values of group B (9.22 months) and group C (9.38 months) were not significantly different (χ2 = 0.456, P = 0.499). The incidences of proteinuria, hand-foot skin reaction, myelosuppression, and gastrointestinal reaction were similar between group B and group C (P = 0.173, 0.188, 1.00, 0.154, respectively). Myelosuppression and gastrointestinal reaction were more common in group A than in group B and group C (P < 0.001). For mCRC, anlotinib as a third-line treatment is better than chemotherapy and similar to regorafenib or fruquintinib. The associated adverse reactions are tolerable.",2020,Myelosuppression and gastrointestinal reaction were more common in group A than in group B and group C (P < 0.001).,"['105 mCRC patients who failed at least two lines of chemotherapy were collected', 'metastatic colorectal cancer', 'metastatic colorectal cancer (mCRC']","['chemotherapy and regorafenib', 'line chemotherapy', 'fruquintinib or regorafenib']","['Myelosuppression and gastrointestinal reaction', 'ORR and DCR', 'mean PFS values', 'mean OS values', 'incidences of proteinuria, hand-foot skin reaction, myelosuppression, and gastrointestinal reaction']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}]",105.0,0.0192365,Myelosuppression and gastrointestinal reaction were more common in group A than in group B and group C (P < 0.001).,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Dalian Medical University, Dalian, China.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Du', 'Affiliation': 'Department of Oncology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Qingdao University, Yantai, China.'}, {'ForeName': 'F Q', 'Initials': 'FQ', 'LastName': 'Fang', 'Affiliation': 'Department of Oncology, First Affiliated Hospital of Dalian Medical University, Dalian Medical University, Dalian, China.'}, {'ForeName': 'Z J', 'Initials': 'ZJ', 'LastName': 'Duan', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Dalian Medical University, Dalian Medical University, Dalian, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Dalian Medical University, Dalian, China.'}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Shi', 'Affiliation': 'Dalian Medical University, Dalian, China.'}]",Neoplasma,['10.4149/neo_2020_191125N1212']
2214,32657642,The Role of CO 2  on Respiration and Metabolism During Hypercapnic and Normocapnic Recovery From Exercise.,"High intensity exercise can lead to depletion of CO 2  from the body (hypocapnia). This disturbance becomes more noticeable during recovery or between seasons of intermittent exercise, putting the subject in a neural fatigue state.  Objectives : A possible hypothesis to address this condition would be to provide high CO 2  mixtures (hypercapnic) during the recovery period from exercise in order to relieve hypocapnia.  Methods : Eight men (23.8 ± 1.2 yrs, V̇O 2max  = 45 ± 1.9 ml▪kg-1▪min-1) performed cycling exercise at 80%V̇O 2max  for 6-7 min. During recovery (23 min) they inhaled hypercapnic air (EXP-21%O2, 3%CO 2 , and 76%N 2 ) or normal air (CON-21%O 2 , 0.003%CO 2 , and 79%N 2 ). Respiratory parameters were collected with open spirometry and heart rate was measured.  Results : Exercise caused mild hypocapnia {9.9 mmHg drop of CO 2  end-expiratory partial pressure (P ET CO 2 )} in CON condition after exercise ( p  < .005). P ET CO 2  elevated close to the rest values during the three hypercapnic phases in EXP condition (main effect of condition  p  < .001 between EXP and CON), but after hypercapnic breathing it returned to hypocapnia similarly with CON. The ventilatory response (V̇ E ▪P ET CO 2   -1 ) and the exhaled volume of CO 2  (V̇CO 2 ) progressively increased during and also after ventilatory manipulations in EXP compared to CON condition (V̇ E ▪P ET CO 2   -1 : post hoc  p  < .001, V̇CO 2 :  p V̇CO 2 :  p  < .05-.001), and V̇O 2  became lower after the end of second hypercapnic manipulation ( p  < .05 between EXP and CON).  Conclusion : It seems that hypercapnic breathing after exercise is not a good strategy to reverse exercise hypocapnia, because of great hyperventilation caused by CO 2  and exercise mechanisms during the recovery period leading to increased CO 2  removal from body. This intervention may also decrease O 2  supply and muscles blood flow.",2020,Exercise caused mild hypocapnia {9.9 mmHg drop of CO 2  end-expiratory partial pressure (P ET CO 2 )} in CON condition after exercise ( p  < .005).,"['Eight men (23.8 ± 1.2 yrs, V̇O 2max  = 45 ± 1.9']","['cycling exercise at 80%V̇O 2max  for 6-7 min', 'inhaled hypercapnic air (EXP-21%O2, 3%CO 2 , and 76%N 2 ) or normal air (CON-21%O 2 , 0.003%CO 2 , and 79%N 2 ', 'High intensity exercise']","['exhaled volume of CO 2  (V̇CO 2 ', 'heart rate', 'mild hypocapnia {9.9 mmHg drop of CO 2  end-expiratory partial pressure (P ET CO 2 )} in CON condition', 'O 2  supply and muscles blood flow', 'ventilatory response']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C4517517', 'cui_str': '1.9'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0085383', 'cui_str': 'Hypocapnia'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0205615,Exercise caused mild hypocapnia {9.9 mmHg drop of CO 2  end-expiratory partial pressure (P ET CO 2 )} in CON condition after exercise ( p  < .005).,"[{'ForeName': 'Theodoros S', 'Initials': 'TS', 'LastName': 'Tsakiris', 'Affiliation': 'University of Athens.'}, {'ForeName': 'Athanasios I', 'Initials': 'AI', 'LastName': 'Konstantopoulos', 'Affiliation': 'University of Athens.'}, {'ForeName': 'Dimitrios I', 'Initials': 'DI', 'LastName': 'Bourdas', 'Affiliation': 'University of Athens.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1756196']
2215,32657670,"Hepatoprotective Effect of  Antrodia cinnamomea  Mycelium in Patients with Nonalcoholic Steatohepatitis: A Randomized, Double-Blind, Placebo-Controlled Trial.","Objective:  Nonalcoholic steatohepatitis (NASH) has become a prominent liver disease in contemporary society because of the changing dieting styles. Complicated syndromes often accompanied by obesity and diabetes makes no standard treatment for NASH. Therefore, we investigated the potential role of  Antrodia cinnamomea  mycelium (ACM) as nutraceutical supplementation in the treatment of NASH in this 6-month randomized, double-blind, placebo-controlled study. Method:  28 Participants were treated with three capsules per day containing either 420 mg of ACM or 420 mg of starch as a placebo. The participants were required to follow a predetermined regular visit to hospital every three months during the intervention period (6 months). During each study visit, subjects underwent anthropometric measurements and blood testing for biochemical analysis, immune function assay, inflammatory cytokines assay, and FibroMax test. Results:  The ACM supplemented group had a significant improvement in steatosis and decreased in the inflammatory marker of TNF-α after three and six months. NASH patients who received ACM showed a significant decrease in the SteatoTest mean value from 0.66 at baseline to 0.49 at 6 months ( p  < 0.029) and the ActiTest mean value decreased from 0.46 at baseline to 0.30 at 6 months ( p  < 0.029). Conclusion:  This is the first clinical investigation that explores the hepatoprotective effect of  A. cinnamomea  mycelium in patients with NASH. No participants experienced any adverse events during the study, which suggested that ACM is a safe alternative treatment for NASH.",2020,The ACM supplemented group had a significant improvement in steatosis and decreased in the inflammatory marker of TNF-α after three and six months.,"['28 Participants', 'Patients with Nonalcoholic Steatohepatitis', 'patients with NASH']","['Nonalcoholic steatohepatitis (NASH', 'Placebo', 'ACM', 'Antrodia cinnamomea  mycelium (ACM', 'NASH', 'ACM or 420\u2009mg of starch as a placebo', 'Antrodia cinnamomea  Mycelium', 'placebo']","['SteatoTest mean value', 'inflammatory marker of TNF-α', 'steatosis', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001143', 'cui_str': 'Aclarubicin'}, {'cui': 'C1082344', 'cui_str': 'Antrodia'}, {'cui': 'C0949695', 'cui_str': 'Mycelium'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.245419,The ACM supplemented group had a significant improvement in steatosis and decreased in the inflammatory marker of TNF-α after three and six months.,"[{'ForeName': 'Ya-Ling', 'Initials': 'YL', 'LastName': 'Chiou', 'Affiliation': 'Department of Nutrition, Master Program of Biomedical Nutrition, Hungkuang University, Taichung City, Taiwan.'}, {'ForeName': 'Charng-Cherng', 'Initials': 'CC', 'LastName': 'Chyau', 'Affiliation': 'Research Institute of Biotechnology, Hungkuang University, Taichung City, Taiwan.'}, {'ForeName': 'Tsung-Ju', 'Initials': 'TJ', 'LastName': 'Li', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd, Taoyuan City, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Kuo', 'Affiliation': 'Department of Food Science, Nutrition, and Nutraceutical Biotechnology, Shih Chien University, Taipei City, Taiwan.'}, {'ForeName': 'Yu-Yling', 'Initials': 'YY', 'LastName': 'Kang', 'Affiliation': 'Department of Nutrition, Master Program of Biomedical Nutrition, Hungkuang University, Taichung City, Taiwan.'}, {'ForeName': 'Chin-Chu', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd, Taoyuan City, Taiwan.'}, {'ForeName': 'Wang-Sheng', 'Initials': 'WS', 'LastName': 'Ko', 'Affiliation': 'Department of Nutrition, Master Program of Biomedical Nutrition, Hungkuang University, Taichung City, Taiwan.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1779850']
2216,32657901,"Effects of a Roy's Adaptation Model-Guided Support Group Intervention on Sexual Adjustment, Body Image, and Perceived Social Support in Women With Breast Cancer.","BACKGROUND


The side effects of local and systemic treatments for breast cancer negatively impact the body image, sexual functioning, and social life of women on treatment for breast cancer. One of the ways to help these women adapt to their disease and cope with the effects of the disease and the side effects of its treatment is through support groups.
OBJECTIVE


The aim of this study was to investigate the effect of a support group intervention, guided by Roy's Adaptation Model, on sexual adaptation, body image, and perceived social support in women on treatment for cancer.
METHODS


The study had a quasi-experimental design with pretests and posttests and a control group. The sample included 79 women, 42 in the control group and 37 in the intervention group. Data were gathered with demographic and clinical forms, the Sexual Adjustment and Body Image Scale, and the Multidimensional Scale of Perceived Social Support. The intervention group received a support group intervention guided by Roy's Adaptation Model.
RESULTS


The intervention group had significantly higher scores for perceived social support, post body image, impact on sexual functioning, and friendly and significant others than the control group did.
CONCLUSION


The Roy's Adaptation Model-based support group intervention contributes positively to physiologic, self-concept, role-function, and interdependence modes by creating a positive effect on body image, improving sexual functions, and increasing social support for women on treatment for breast cancer.
IMPLICATIONS FOR PRACTICE


This support group intervention may enhance care outcomes in women on treatment for cancer and could thus be incorporated into standard care for this patient group.",2020,"The intervention group had significantly higher scores for perceived social support, post body image, impact on sexual functioning, and friendly and significant others than the control group did.
","['79 women, 42 in the control group and 37 in the intervention group', 'Women With Breast Cancer', 'women on treatment for breast cancer', 'women on treatment for cancer']","[""Roy's Adaptation Model-Guided Support Group Intervention"", ""support group intervention, guided by Roy's Adaptation Model, on sexual adaptation, body image, and perceived social support"", ""support group intervention guided by Roy's Adaptation Model""]","['higher scores for perceived social support, post body image, impact on sexual functioning', 'Sexual Adjustment, Body Image, and Perceived Social Support']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",79.0,0.0220596,"The intervention group had significantly higher scores for perceived social support, post body image, impact on sexual functioning, and friendly and significant others than the control group did.
","[{'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Erol Ursavaş', 'Affiliation': 'Author Affiliations: Faculty of Health Science, Department of Nursing, Çankırı Karatekin University, Çankırı (Dr Erol Ursavaş); and Faculty of Health Science, Department of Nursing, Izmir University of Economics, İzmir, Turkey (Prof Dr Karayurt).'}, {'ForeName': 'Özgül', 'Initials': 'Ö', 'LastName': 'Karayurt', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000854']
2217,32657903,"Effect of Massage With Lavender Oil on Postoperative Pain Level of Patients Who Underwent Gynecologic Surgery: A Randomized, Placebo-Controlled Study.","This was a randomized, placebo-controlled study. The sample consisted of 3 groups of patients: an experimental group, massage application with lavender oil (n = 15); a placebo group, massage application with ultrasound gel (n = 15); and a control group (n = 15). Massage application was performed 3 hours after analgesic application. Pain levels of the patients in the experiment and placebo groups were evaluated with a Verbal Rating Scale (VRS) at the 30th minute and the 3rd hour after the application. Similarly, the pain level of patients in the control group was also evaluated with the VRS at 3 hours after the initial analgesic administration and following the 30th minute and the 3rd hour. Generally, the VRS scores of the 3 groups did not show a significant difference in terms of group and time interaction (P = .221). However, there was a significant difference in VRS scores between the experimental and control groups at the 30th minute after the massage (P = .036). This difference was caused by the lower pain level of the group, which had massage with lavender (2.66 ± .89) compared with the control group (3.80 ± 1.01). According to the study results, while only hand massage application after gynecologic surgery was effective for a short period in decreasing postoperative pain, it was determined that massage application with lavender had a longer effect in decreasing postoperative pain. The results of this study showed that this inexpensive and easy-to-apply method can be safely performed by nurses on postoperative patients and can support pain management of patients in the first hours after gynecologic surgery.",2020,"Generally, the VRS scores of the 3 groups did not show a significant difference in terms of group and time interaction (P = .221).",['Patients'],"['Placebo', 'placebo group, massage application with ultrasound gel', 'Gynecologic Surgery', 'massage application with lavender oil', 'Massage With Lavender Oil', 'placebo']","['pain level', 'VRS scores', 'Verbal Rating Scale (VRS', 'postoperative pain', 'Postoperative Pain Level', 'Pain levels', 'lower pain level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C4274441', 'cui_str': 'Verbal Rating Scale score'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",15.0,0.0474795,"Generally, the VRS scores of the 3 groups did not show a significant difference in terms of group and time interaction (P = .221).","[{'ForeName': 'Berrak', 'Initials': 'B', 'LastName': 'Mizrak Sahin', 'Affiliation': 'Nursing Department, Faculty of Health Sciences (Drs Mizrak Sahin, Culha, and Gursoy), and Department of Obstetrics and Gynecology, Faculty of Medicine (Dr Yalcin), Eskisehir Osmangazi University, Eskisehir, Turkey.'}, {'ForeName': 'Ilkay', 'Initials': 'I', 'LastName': 'Culha', 'Affiliation': ''}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Gursoy', 'Affiliation': ''}, {'ForeName': 'Omer Tarik', 'Initials': 'OT', 'LastName': 'Yalcin', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000400']
2218,32657909,Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses.,"PURPOSE


The safety of immunosuppressive regimens is influenced by the induction agent, maintenance drug combination, and prophylactic strategy for cytomegalovirus (CMV) infection. Herein, this safety analysis compares rabbit anti-thymocyte globulin (r-ATG) or basiliximab (BAS) combined with everolimus (EVR) versus BAS combined with mycophenolate sodium (MPS) in kidney transplant recipients receiving tacrolimus, prednisone, and preemptive CMV therapy.
METHODS


In this single-center, prospective, randomized study, adverse events (AEs), serious adverse events (SAEs), viral infections, laboratory abnormalities, dose reductions, and temporary or permanent discontinuation of the immunosuppressant were compared among patients receiving r-ATG/EVR (n=85), BAS/EVR (n=102), and BAS/MPS (n=101).
RESULTS


A total of 2741 AEs and 344 SAEs were observed. There were no differences in the proportion of patients with at least one AE (96% vs 98% vs 96%, respectively, p>0.05). The proportion of patients with at least one SAE was highest in the BAS/MPS group (33% vs 48% vs 69%, respectively, p<0.05). This difference was due primarily to a high incidence of CMV infection in the BAS/MPS group (4.7% vs 10.8% vs 37.6%, respectively). The incidence of mild/moderate abnormalities in creatinine, cholesterol, and triglyceride levels was higher in both EVR groups. The cumulative freedom from dose reduction or treatment discontinuation due to an AE was higher in both EVR groups than in the BAS/MPS group (89.2% vs 92.8% vs 76.3%, respectively, p=0.003). There was no difference in the incidence of biopsy-confirmed acute rejection (9.4% vs 18.6 vs 15.8%, respectively, p=0.403).
CONCLUSION


This analysis suggests that r-ATG induction combined with EVR is associated with a comparable incidence of acute rejection, lower incidence of CMV infection, and fewer changes in initial immunosuppressive regimen due to AEs in kidney transplant recipients receiving tacrolimus, prednisone, and preemptive CMV therapy.",2020,"The cumulative freedom from dose reduction or treatment discontinuation due to an AE was higher in both EVR groups than in the BAS/MPS group (89.2% vs 92.8% vs 76.3%, respectively, p=0.003).","['De Novo Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses', 'kidney transplant recipients receiving']","['tacrolimus, prednisone, and preemptive CMV therapy', 'BAS/MPS', 'rabbit anti-thymocyte globulin (r-ATG) or basiliximab (BAS) combined with everolimus (EVR) versus BAS combined with mycophenolate sodium (MPS']","['cumulative freedom', 'incidence of mild/moderate abnormalities in creatinine, cholesterol, and triglyceride levels', 'adverse events (AEs), serious adverse events (SAEs), viral infections, laboratory abnormalities, dose reductions, and temporary or permanent discontinuation of the immunosuppressant', 'CMV infection', 'incidence of biopsy-confirmed acute rejection']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C1337395', 'cui_str': 'Mycophenolate sodium'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}]",2741.0,0.0441977,"The cumulative freedom from dose reduction or treatment discontinuation due to an AE was higher in both EVR groups than in the BAS/MPS group (89.2% vs 92.8% vs 76.3%, respectively, p=0.003).","[{'ForeName': 'Tamiris Abait', 'Initials': 'TA', 'LastName': 'Miranda', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo.'}, {'ForeName': 'Claudia Rosso', 'Initials': 'CR', 'LastName': 'Felipe', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo.'}, {'ForeName': 'Renato Hideo', 'Initials': 'RH', 'LastName': 'Nakagawa Santos', 'Affiliation': 'Instituto de Pesquisa HCor.'}, {'ForeName': 'Jose Osmar', 'Initials': 'JO', 'LastName': 'Medina Pestana', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva Junior', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000790']
2219,32657920,Banded Versus Nonbanded Sleeve Gastrectomy: A Randomized Controlled Trial With 3 Years of Follow-up.,"OBJECTIVE


The aim of this study was to compare silicone-banded sleeve gastrectomy (BSG) to nonbanded sleeve gastrectomy (SG) regarding weight loss, obesity-related comorbidities, and complications.
SUMMARY BACKGROUND DATA


As a primary bariatric procedure, SG leads to excellent weight loss, yet weight regain is a relevant issue in mid- to long-term follow-up. Retrospective analyses suggest that banding a sleeve using a silicone ring may decrease weight regain and improve weight loss.
METHODS


The banded versus nonbanded sleeve gastrectomy single-center, randomized controlled trial was conducted from January 2015 to August 2019. The primary endpoint was defined as excess weight loss 3 years after surgery. Secondary endpoints included the surgery's impact on obesity-related comorbidities, quality of life, and complications. The study was registered under DRKS00007729.
RESULTS


Among 94 patients randomized, 97% completed 3-year follow-up. Mean initial body mass index was 50.9 kg/m [95% confidence interval (CI), 49.6-52.2]. Mean adjusted excess weight loss 3 years after SG amounted to 62.3% (95% CI, 56.2-68.5) and 73.9% ( 95% CI, 67.8-80.0) after BSG (difference 11.6%, P = 0.0073). Remission of type 2 diabetes occurred in 66.7% (4/6) after SG and in 91.0% (10/11) following BSG (P = 0.21). Three years after surgery, ring implantation correlated with decreased frequency of symptomatic reflux episodes (P = 0.01) but increased frequency of regurgitation (P = 0.03). The rate of major complications was not different between the study groups (BSG, n = 3; SG, n = 2; P = 0.63). Quality of life was better following BSG (P = 0.001).
CONCLUSIONS


BSG provided better weight loss than nonbanded SG 3 years after surgery. Regurgitation was the main clinically relevant negative effect after BSG.",2020,"Quality of life was better following BSG (P = 0.001).
","['94 patients randomized, 97% completed 3-year follow-up']","['banded versus nonbanded sleeve gastrectomy single-center', 'Banded Versus Nonbanded Sleeve Gastrectomy', 'silicone-banded sleeve gastrectomy (BSG', 'nonbanded sleeve gastrectomy (SG']","['Remission of type 2 diabetes', 'frequency of symptomatic reflux episodes', 'Mean initial body mass index', 'weight regain and improve weight loss', 'Mean adjusted excess weight loss 3 years after SG', 'frequency of regurgitation', 'weight loss', ""surgery's impact on obesity-related comorbidities, quality of life, and complications"", 'excess weight loss 3 years after surgery', 'Quality of life', 'rate of major complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",94.0,0.15993,"Quality of life was better following BSG (P = 0.001).
","[{'ForeName': 'Jodok M', 'Initials': 'JM', 'LastName': 'Fink', 'Affiliation': 'Department of General and Visceral Surgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hetzenecker', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': ''}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Runkel', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Laessle', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fichtner-Feigl', 'Affiliation': ''}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Marjanovic', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004174']
2220,32657946,"A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103).","BACKGROUND AND OBJECTIVE


Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI.
METHODS


Randomized, double-blind, placebo-controlled trial of single dose reltecimod (0.5 mg/kg) administered within 6 hours of NSTI diagnosis at 65 of 93 study sites. Inclusion: surgical confirmation of NSTI and organ dysfunction [modified Sequential Organ Failure Assessment Score (mSOFA) score ≥3]. Primary analysis was modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution). A prespecified, per protocol (PP) analysis excluded 17 patients with major protocol violations before unblinding.
RESULTS


Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148): mean age 55 ± 15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5 ± 2.4. Twenty-eight-day mortality was 15% in both groups. mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 and PP was 54.3% reltecimod versus 40.3% placebo, P = 0.021. Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.
CONCLUSION


Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status.",2020,"Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.
","['17 patients with major protocol violations before unblinding', 'Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148', 'mean age 55\u200a±\u200a15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5\u200a±\u200a2.4', 'Patients With Necrotizing Soft Tissue Infections (NSTI']","['reltecimod', 'placebo']","['mITT necrotizing infection clinical composite endpoint success', 'modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution', 'resolution of organ dysfunction', 'Resolution of organ dysfunction', 'resolution of organ dysfunction and hospital discharge status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C1868725', 'cui_str': 'Perineal infection'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0275521', 'cui_str': 'Clinical infection'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",290.0,0.653613,"Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.
","[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': 'University of Washington, Harborview Medical Center, Seattle, Washington.'}, {'ForeName': 'Addison K', 'Initials': 'AK', 'LastName': 'May', 'Affiliation': 'Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'University of Washington, Harborview Medical Center, Seattle, Washington.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Evans', 'Affiliation': 'Ohio Health, Grant & Mansfield Hospitals, Columbus, Ohio.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Henry', 'Affiliation': 'University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Green', 'Affiliation': 'Carolinas Medical Center, Charlotte, North Carolina.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Toschlog', 'Affiliation': 'East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fagenholz', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Niels D', 'Initials': 'ND', 'LastName': 'Martin', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Dankner', 'Affiliation': 'Atox Bio Ltd, Durham, North Carolina.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Maislin', 'Affiliation': 'Biomedical Statistical Consulting, Wynnewood, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilfret', 'Affiliation': 'Atox Bio Ltd, Durham, North Carolina.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Bernard', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004102']
2221,32658020,Optimal Technical Factors During Operative Management of Low Energy Femoral Neck Fractures.,"OBJECTIVE


To determine if cancellous screw and sliding hip screw technical factors during low energy femoral neck fracture fixation affects 24-month revision surgery rate and health-related quality of life.
DESIGN


Prospective randomized controlled study.
SETTING


International, multicenter.
PATIENTS


898 femoral neck fracture patients age 50 years and older.
INTERVENTION


Patients were randomized to fracture stabilization with either cancellous screws or a sliding hip screw device as part of the Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH) trial. Cancellous screw technical factors analyzed included screw diameter, short versus long screw threads, screw number and formation, screw orientation and washer use. Sliding hip screw technical factors studied were side plate length, supplemental screw use, lag screw position, and tip-apex distance.
MAIN OUTCOME MEASUREMENTS


Revision surgery within 24 months to promote fracture healing, relieve pain, treat infection or improve function. Additionally, health-related quality of life measures were collected, including the SF-12 PCS and WOMAC.
RESULTS


The three-screw inverted triangle pattern had a significantly lower revision surgery rate than a three-screw triangle formation (p=0.004). No other cancellous screw or sliding hip screw technical factors were predictive of revision surgery or affected a patient's health-related quality of life (p>0.05).
CONCLUSIONS


A three-screw inverted triangle pattern was superior to a three-screw triangle formation. However, injury and patient factors such as fracture displacement, age, smoking status and sex play a more significant role in clinical outcomes for low energy femoral neck fracture treatment.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"No other cancellous screw or sliding hip screw technical factors were predictive of revision surgery or affected a patient's health-related quality of life (p>0.05).
","['898 femoral neck fracture patients age 50 years and older', 'Low Energy Femoral Neck Fractures']",['fracture stabilization with either cancellous screws or a sliding hip screw device as part of the Fixation Using Alternative Implants'],"['revision surgery rate', 'health-related quality of life measures', 'side plate length, supplemental screw use, lag screw position, and tip-apex distance', 'fracture healing, relieve pain, treat infection or improve function']","[{'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",898.0,0.085593,"No other cancellous screw or sliding hip screw technical factors were predictive of revision surgery or affected a patient's health-related quality of life (p>0.05).
","[{'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Schottel', 'Affiliation': 'University of Vermont Medical Center, Burlington, Vermont, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blankstein', 'Affiliation': 'University of Vermont Medical Center, Burlington, Vermont, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Swiontkowski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001891']
2222,32658083,Risk Factors Analysis and Nomogram Development for Pancreatic Pseudocyst in Idiopathic Chronic Pancreatitis.,"OBJECTIVE


The study concerns identifying risk factors and developing nomogram for pancreatic pseudocyst (PPC) in idiopathic chronic pancreatitis (ICP) to facilitate early diagnosis.
METHODS


From January 2000 to December 2013, ICP patients admitted to our center were enrolled. Cumulative incidence of PPC was determined by Kaplan-Meier method. Patients were randomized into training group and validation group in a 2:1 ratio. Risk factors of PPC were determined through Cox proportional hazards regression model based on training cohort. The nomogram was constructed according to risk factors.
RESULTS


Totally, 1633 ICP patients were included with a median follow-up duration of 9.8 years. Pancreatic pseudocyst was observed in 14.7% (240/1633) of patients after ICP onset. The cumulative incidences of PPC were 8.2%, 10.4%, and 12.9% at 3, 5, and 10 years after ICP onset, respectively. Male sex, smoking history, history of severe acute pancreatitis, and chronic pain at/before diagnosis of ICP and complex pathologic changes in main pancreatic duct were recognized as risk factors of PPC development. The nomogram constructed with these risk factors achieved good concordance indexes.
CONCLUSIONS


Risk for PPC could be estimated through the nomogram. High-risk patients were suggested to be followed up closely to help early diagnosis of PPC.",2020,"The cumulative incidences of PPC were 8.2%, 10.4%, and 12.9% at 3, 5, and 10 years after ICP onset, respectively.","['idiopathic chronic pancreatitis (ICP', '1633 ICP patients were included with a median follow-up duration of 9.8 years', 'Idiopathic Chronic Pancreatitis', 'High-risk patients', 'From January 2000 to December 2013, ICP patients admitted to our center were enrolled']",[],"['Cumulative incidence of PPC', 'Pancreatic pseudocyst', 'cumulative incidences of PPC']","[{'cui': 'C0341471', 'cui_str': 'Idiopathic chronic pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030299', 'cui_str': 'Pseudocyst of pancreas'}]",,0.0195207,"The cumulative incidences of PPC were 8.2%, 10.4%, and 12.9% at 3, 5, and 10 years after ICP onset, respectively.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Huai-Yu', 'Initials': 'HY', 'LastName': 'Yang', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Jia-Yi', 'Initials': 'JY', 'LastName': 'Ma', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Hong-Lei', 'Initials': 'HL', 'LastName': 'Guo', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Ya-Wei', 'Initials': 'YW', 'LastName': 'Bi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Beijing.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xin', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Xiang-Peng', 'Initials': 'XP', 'LastName': 'Zeng', 'Affiliation': 'Department of Digestive Diseases, 900 Hospital of the Joint Logistics Team, Fuzhou.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Cong', 'Affiliation': 'Department of General Surgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Zhao-Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}, {'ForeName': 'Liang-Hao', 'Initials': 'LH', 'LastName': 'Hu', 'Affiliation': 'From the Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai.'}]",Pancreas,['10.1097/MPA.0000000000001610']
2223,32658147,A digital health psychological intervention (WebMAP Mobile) for children and adolescents with chronic pain: results of a hybrid effectiveness-implementation stepped wedge cluster randomized trial.,"Although psychological treatments benefit youth with chronic pain, treatment is not accessible in most communities. Digital health interventions offer promise for expanding access and reach to this population. Using a stepped wedge cluster randomized trial design, we evaluated effectiveness and implementation of a digital health delivered psychological intervention for pediatric chronic pain. 143 youth, ages 10-17 with chronic pain and a caregiver were recruited from 8 clinics in the United States. Active intervention included access to the WebMAP Mobile App and the WebMAP parent website to learn pain self-management skills. Effectiveness outcomes included pain intensity, disability, and patient global impression of change (PGIC), while Reach, Adoption, Implementation, and Maintenance were implementation outcomes. Results showed that youth in both treatment conditions (WebMAP vs Usual Care) had similar changes over time in pain and disability. Youth in the WebMAP condition perceived greater improvement (PGIC) at post-treatment and follow-up (d's = 0.54 and 0.44, p < .05) compared to youth receiving usual care. Use of the digital health intervention was modest and variable; about 30% of youth and parents completed treatment. Greater engagement (number of completed modules) was associated with significantly greater reductions in pain and disability from pre-treatment to follow-up (d's = -0.57 and -0.38, p < .05). Parents, youth, and providers found treatment acceptable; providers had positive attitudes and demonstrated referrals over a maintenance period. Further research is needed to understand how to enhance treatment engagement with digital health interventions and optimize implementation.",2020,Youth in the WebMAP condition perceived greater improvement (PGIC) at post-treatment and follow-up,"['143 youth, ages 10-17 with chronic pain and a caregiver were recruited from 8 clinics in the United States', 'children and adolescents with chronic pain', 'pediatric chronic pain']","['digital health intervention', 'digital health delivered psychological intervention', 'Digital health interventions', 'digital health psychological intervention (WebMAP Mobile']","['pain intensity, disability, and patient global impression of change (PGIC), while Reach, Adoption, Implementation, and Maintenance were implementation outcomes', 'improvement (PGIC', 'pain and disability']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.138307,Youth in the WebMAP condition perceived greater improvement (PGIC) at post-treatment and follow-up,"[{'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Rocio de la', 'Initials': 'R', 'LastName': 'Vega', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Law', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}]",Pain,['10.1097/j.pain.0000000000001994']
2224,32658250,"Long-term safety and immunogenicity of a tetravalent dengue vaccine candidate in children and adults: a randomized, placebo-controlled, phase 2 study.","BACKGROUND


We report long-term safety and immunogenicity of Takeda's tetravalent dengue vaccine candidate (TAK-003) in healthy children and adults living in dengue-endemic areas in Puerto Rico, Columbia, Singapore, and Thailand (NCT01511250).
METHODS


In part 1 of this phase 2, randomized, placebo-controlled trial we sequentially enrolled 1.5-45 year-olds (N=148) into four age-descending groups, randomized 2:1 to receive two doses of TAK-003 or placebo 90 days apart. In part 2, 1-11 year-olds (N=212) were enrolled and randomized 3:1 to TAK-003 or placebo groups. We assessed neutralizing antibody titers for the four dengue serotypes (DENV) up to Month 36 in part 1, and symptomatic dengue and serious adverse events (SAEs) up to Month 36 in both parts.
RESULTS


At Month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively. Seropositivity rates varied significantly for DENV-4 according to serostatus at baseline (89.5% in seropositives versus 21.6% in seronegatives). No vaccine-related SAEs were reported.
CONCLUSION


The trial demonstrated persistence of neutralizing antibody titers against TAK-003 over three years in children and adults living in dengue endemic countries, with limited contribution from natural infection. TAK-003 was well tolerated.",2020,"At Month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively.","['In part 2, 1-11 year-olds (N=212', 'children and adults living in dengue endemic countries', 'healthy children and adults living in dengue-endemic areas in Puerto Rico, Columbia, Singapore, and Thailand (NCT01511250', 'children and adults', 'sequentially enrolled 1.5-45 year-olds (N=148) into four age-descending groups']","['TAK-003 or placebo', ""Takeda's tetravalent dengue vaccine candidate (TAK-003"", 'placebo']","['neutralizing antibody titers', 'Seropositivity rates', 'seropositivity rates', 'tolerated']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}]","[{'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",212.0,0.609438,"At Month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively.","[{'ForeName': 'Chukiat', 'Initials': 'C', 'LastName': 'Sirivichayakul', 'Affiliation': 'Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Barranco-Santana', 'Affiliation': 'CAIMED center, Ponce School of Medicine, Ponce Health Sciences University, Ponce, Puerto Rico.'}, {'ForeName': 'Inés Esquilín', 'Initials': 'IE', 'LastName': 'Rivera', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Puerto Rico, Puerto Rico.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kilbury', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Raanan', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Athanasia', 'Initials': 'A', 'LastName': 'Papadimitriou', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa406']
2225,32658264,Cardiovascular Safety of Abaloparatide in Postmenopausal Women with Osteoporosis: Analysis from the ACTIVE Phase 3 Trial.,"CONTEXT


Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
OBJECTIVES


We assessed the cardiovascular safety profile of abaloparatide.
DESIGN


Review of heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACE) and heart failure (HF) from: (a) ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months; (b) ACTIVExtend (NCT01657162), where participants from the abaloparatide and placebo arms received alendronate for 2 years; and (c) a pharmacology study in 55 healthy adults.
RESULTS


Abaloparatide and teriparatide transiently increased HR relative to placebo. Following first dose, mean (SD) HR change from pre-treatment to 1 hour post treatment was 7.9 (8.5) bpm for abaloparatide, 5.3 (7.5) for teriparatide, and 1.2 (7.1) for placebo. A similar pattern was observed over subsequent visits. In healthy volunteers, HR increase resolved within 4 hours. The corresponding change in mean supine systolic and diastolic BP 1 hour post treatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo). The percentage of participants with serious cardiac AEs was similar among groups (0.9‒1.0%). In a post hoc analysis, time-to-first incidence of MACE + HF was longer with abaloparatide (P = 0.02 versus placebo) and teriparatide (P = 0.04 versus placebo).
CONCLUSIONS


Abaloparatide was associated with transient increases in HR and small decreases in BP in postmenopausal women with osteoporosis, with no increase in risk of serious cardiac AEs, MACE, or HF.",2020,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","['postmenopausal women at high risk of fracture', 'Postmenopausal Women with Osteoporosis', 'postmenopausal women with osteoporosis', 'healthy volunteers', 'for 18 months', '2463 postmenopausal women with osteoporosis to abaloparatide', '55 healthy adults']","['teriparatide', 'teriparatide, or placebo', 'Abaloparatide', 'alendronate', 'abaloparatide and placebo', 'placebo']","['heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACE) and heart failure (HF', 'mean (SD) HR change', 'risk of serious cardiac AEs, MACE, or HF', 'mean supine systolic and diastolic BP', 'percentage of participants with serious cardiac AEs', 'Cardiovascular Safety', 'HR relative']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",2463.0,0.501999,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","[{'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Diabetic Cardiovascular Disease Center and Department of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Dwight A', 'Initials': 'DA', 'LastName': 'Towler', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Clinical Development, Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Cummings', 'Affiliation': 'San Francisco Coordinating Center, Sutter Health, California; University of California, San Francisco, CA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa450']
2226,32658298,Telemedicine Versus Face-to-Face Delivery of Cognitive Behavioral Therapy for Insomnia: A Randomized Controlled Non-Inferiority Trial.,"STUDY OBJECTIVES


In a randomized controlled non-inferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of CBT for insomnia for improving insomnia/sleep and daytime functioning at post-treatment and 3-month follow-up. A secondary objective compared the modalities on treatment credibility, satisfaction, and therapeutic alliance.
METHODS


Sixty-five adults with chronic insomnia (46 women, 47.2 ± 16.3 years of age) were randomized to 6 sessions of CBT for insomnia delivered individually via AASM SleepTM (n=33, CBT-TM) or face-to-face (n=32, CBT-F2F). Participants completed sleep diaries, the Insomnia Severity Index (ISI), and daytime functioning measures at pre-treatment, post-treatment, and 3-month follow-up. Treatment credibility, satisfaction, and therapeutic alliance were compared between treatment modalities. The ISI was the primary non-inferiority outcome.
RESULTS


Based on a non-inferiority margin of 4 points on the ISI and, after adjusting for confounders, CBT-TM was non-inferior to CBT-F2F at post-treatment (β = 0.54, SE=1.10, 95% CI -1.64 to 2.72) and follow-up (β = 0.34, SE=1.10, 95% CI -1.83 to 2.53). Daytime functioning measures, except the physical composite scale of the SF-12, were significantly improved at post-treatment and follow-up, with no difference between treatment formats. CBT-TM sessions were, on average, nearly 10 minutes shorter, yet participant ratings of therapeutic alliance were similar to CBT-F2F.
CONCLUSIONS


Telemedicine delivery of CBT for insomnia is not inferior to face-to-face for insomnia severity and yields similar improvements on other sleep and daytime functioning outcomes. Further, telemedicine allows for more efficient treatment delivery while not compromising therapeutic alliance.",2020,"Daytime functioning measures, except the physical composite scale of the SF-12, were significantly improved at post-treatment and follow-up, with no difference between treatment formats.","['Insomnia', 'Sixty-five adults with chronic insomnia (46 women, 47.2 ± 16.3 years of age']","['CBT', 'telemedicine', 'Telemedicine Versus Face-to-Face Delivery of Cognitive Behavioral Therapy', 'CBT for insomnia delivered individually via AASM SleepTM (n=33, CBT-TM) or face-to-face']","['insomnia/sleep and daytime functioning', 'treatment credibility, satisfaction, and therapeutic alliance', 'Treatment credibility, satisfaction, and therapeutic alliance', 'sleep diaries, the Insomnia Severity Index (ISI), and daytime functioning measures', 'Daytime functioning measures', 'physical composite scale of the SF-12']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0405135', 'cui_str': 'Face delivery'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",65.0,0.0854961,"Daytime functioning measures, except the physical composite scale of the SF-12, were significantly improved at post-treatment and follow-up, with no difference between treatment formats.","[{'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Sleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Conroy', 'Affiliation': 'Sleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mooney', 'Affiliation': 'Sleep and Circadian Research Laboratory, Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Furgal', 'Affiliation': 'Department of Family Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Family Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eisenberg', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI.'}]",Sleep,['10.1093/sleep/zsaa136']
2227,32658308,Fatty acid sentinels as covalently bound randomization standards for triacylglycerol (TAG) quantitative analysis.,"RATIONALE


Quantitative analysis of triacylglycerols (TAG) is impeded by a lack of standards and the huge number of potential TAG molecular species that may be present due to the combinatorial nature of glycerolipids. Randomization of acyl groups yields TAG mixtures with profiles predictable from fatty acid profiles; however, their use as calibration mixtures has been limited.
METHODS


We introduce here the principle of fatty acid isotopic sentinels that are quantitatively added prior to randomization to enable verification that randomization is complete, and that can be used as internal standards. A mixture of two isotopically labeled fatty acid methyl esters (FAME) is prepared at a ratio of 2:1 and the exact ratio was carefully measured by GC-FID and randomized covalently into the acyl groups of TAG mixtures.
RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile. TAG mixture analysis reveals that the isotopic sentinels have been covalently incorporated into the TAG molecular species at <1% deviation from the expected proportions, thus verifying randomization within experimental error.
CONCLUSIONS


The sentinel principle demonstrated here as covalently incorporated internal standards verifies that randomization chemistry went to completion. It applies in general to use of combinatorial chemistry for quantitative standards.",2020,"RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile.",[],['A mixture of two isotopically labeled fatty acid methyl esters (FAME'],[],[],"[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0014898', 'cui_str': 'Ester'}]",[],3.0,0.0577684,"RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile.","[{'ForeName': 'Dong Hao', 'Initials': 'DH', 'LastName': 'Wang', 'Affiliation': 'Dell Pediatric Research Institute, Depts of Pediatrics, of Chemistry, and of Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, United States.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Dell Pediatric Research Institute, Depts of Pediatrics, of Chemistry, and of Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, United States.'}, {'ForeName': 'Secilia', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Dell Pediatric Research Institute, Depts of Pediatrics, of Chemistry, and of Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, United States.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Tobias', 'Affiliation': 'Dell Pediatric Research Institute, Depts of Pediatrics, of Chemistry, and of Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, United States.'}, {'ForeName': 'J Thomas', 'Initials': 'JT', 'LastName': 'Brenna', 'Affiliation': 'Dell Pediatric Research Institute, Depts of Pediatrics, of Chemistry, and of Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, United States.'}]",Rapid communications in mass spectrometry : RCM,['10.1002/rcm.8891']
2228,32658385,Randomized Trial of Lung Hyperinflation Therapy in Children with Congenital Muscular Dystrophy.,"OBJECTIVE


Respiratory compromise in Congenital Muscular Dystrophy occurs, in part, from chest wall contractures. Passive stretch with hyperinsufflation therapy could reduce related costo-vertebral joint contractures. We sought to examine the impact of hyperinsufflation use on lung function and quality of life in children with congenital muscular dystrophy.
STUDY DESIGN


We conducted a randomized controlled trial on hyperinsufflation therapy in children with congenital muscular dystrophy at two centers. An individualized hyperinsufflation regimen of 15 minutes twice daily using a cough assist device over a 12 months period was prescribed. We measured lung function, quality of life and adherence. To demonstrate reproducibility, pulmonary function was measured twice on the same day. A mixed-effects regression model adjusting for confounders was used to assess the effects of hyperinsufflation.
RESULTS


We enrolled 34 participants in the study; 31 completed the trial (n=17 treatment group and n=14 controls). Participants in the treatment group demonstrated a relative gain in lung volume measured at 4 and 8 months, but not at 12 months. The control group required increases in the maximum insufflation pressures to achieve maximum lung volumes while the treatment group did not. Adherence was best early in the study, peaking at first visit and decreasing at subsequent visits. Caregiver-reported quality of life was higher in the treatment group.
CONCLUSION


Hyperinsufflation therapy is effective in increasing and sustaining lung volume over time. Adherence, however, was inconsistent and difficult to maintain. Further research should determine if improved adherence leads to sustained benefits of hyperinsufflation. This article is protected by copyright. All rights reserved.",2020,"Participants in the treatment group demonstrated a relative gain in lung volume measured at 4 and 8 months, but not at 12 months.","['34 participants in the study; 31 completed the trial (n=17 treatment group and n=14 controls', 'children with congenital muscular dystrophy', 'Children with Congenital Muscular Dystrophy', 'children with congenital muscular dystrophy at two centers']","['hyperinsufflation', 'Hyperinsufflation therapy', 'hyperinsufflation therapy', 'Lung Hyperinflation Therapy']","['lung function, quality of life and adherence', 'costo-vertebral joint contractures', 'relative gain in lung volume', 'reproducibility, pulmonary function', 'Caregiver-reported quality of life', 'lung function and quality of life', 'maximum insufflation pressures', 'Adherence']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0009918', 'cui_str': 'Contracture of joint'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",34.0,0.0666038,"Participants in the treatment group demonstrated a relative gain in lung volume measured at 4 and 8 months, but not at 12 months.","[{'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Sawnani', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Oscar H', 'Initials': 'OH', 'LastName': 'Mayer', 'Affiliation': ""Division of Pulmonary Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Avani C', 'Initials': 'AC', 'LastName': 'Modi', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pascoe', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'McConnell', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'McDonough', 'Affiliation': ""Division of Pulmonary Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Rutkowski', 'Affiliation': 'Cure CMD Foundation and Kaiser SCPMG, Los Angeles, CA.'}, {'ForeName': 'Md M', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Szczesniak', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Dawit G', 'Initials': 'DG', 'LastName': 'Tadesse', 'Affiliation': ""Division of Epidemiology and Biostatistics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Schuler', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Amin', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}]",Pediatric pulmonology,['10.1002/ppul.24954']
2229,32658399,"Cerumenolytic Efficacy of 2.5% Sodium Bicarbonate Versus Docusate Sodium: A Randomized, Controlled Trial.","OBJECTIVES


To evaluate the efficacy of 2.5% sodium bicarbonate and docusate sodium in patients with complete occlusion of the ear canal from impacted cerumen.
STUDY DESIGN


Randomized controlled trial.
METHOD


We enrolled patients with unilateral complete cerumen occlusion of the ear canal that was unable to be removed using suction. Either 2.5% sodium bicarbonate or docusate sodium was applied and allowed to sit for 15 minutes. The ear canal was then cleaned under a microscope for up to 3 minutes until the tympanic membrane was completely visible. A second attempt with the same agent was performed in subjects in whom the first application was unsuccessful. The outcomes were compared between the two groups in terms of cleaning, the success rate, time taken to clean the canal, and adverse events.
RESULTS


There were 91 participants enrolled in this study. The mean age of the participants was 48.0 years. The patients' demographic did not differ between the two groups. At the end of the treatment, the tympanic membrane was completely visible in 41 (91.11%) subjects treated with 2.5% sodium bicarbonate and 38 (82.61%) subjects treated with docusate sodium, with a 1.10 success ratio between the two groups (95% CI: 0.94-1.29, p = 0.23). The mean successful suctioning time was 103.61 seconds using 2.5% sodium bicarbonate and 124.13 using docusate sodium. The mean difference was 20.52 seconds (95% CI: -10.55-51.59).
CONCLUSION


2.5% sodium bicarbonate demonstrated non-inferior efficacy and safety compared with docusate sodium. We recommend using this agent in clinical practice.
TRIAL REGISTRATION


Clinicaltrials.in.th/TCTR20160803001.",2020,"The outcomes were compared between the two groups in terms of cleaning, the success rate, time taken to clean the canal, and adverse events.
","['patients with complete occlusion of the ear canal from impacted cerumen', 'enrolled patients with unilateral complete cerumen occlusion of the ear canal that was unable to be removed using suction', '91 participants enrolled in this study']","['sodium bicarbonate or docusate sodium', 'sodium bicarbonate and docusate sodium', 'Sodium Bicarbonate Versus Docusate Sodium', 'sodium bicarbonate', 'docusate sodium']","['success rate, time taken to clean the canal, and adverse events', 'Cerumenolytic Efficacy', 'mean successful suctioning time', 'tympanic membrane', 'inferior efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0013444', 'cui_str': 'External auditory canal structure'}, {'cui': 'C0021092', 'cui_str': 'Impacted cerumen'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0740486', 'cui_str': 'Cerumen'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0243237', 'cui_str': 'docusate sodium'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2936339', 'cui_str': 'Wax Solvent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",91.0,0.0416517,"The outcomes were compared between the two groups in terms of cleaning, the success rate, time taken to clean the canal, and adverse events.
","[{'ForeName': 'Patorn', 'Initials': 'P', 'LastName': 'Piromchai', 'Affiliation': '*Department of Otorhinolaryngology, Faculty of Medicine †Manufacturing Unit, Pharmacy Department, Srinagarind Hospital, Khon Kaen University, Thailand.'}, {'ForeName': 'Chanticha', 'Initials': 'C', 'LastName': 'Laohakittikul', 'Affiliation': ''}, {'ForeName': 'Sirichoke', 'Initials': 'S', 'LastName': 'Khunnawongkrit', 'Affiliation': ''}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Srirompotong', 'Affiliation': ''}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002672']
2230,32658424,The Relationship between Vitamin D and Vasomotor Symptoms During the Postmenopausal Period.,"BACKGROUND


During the postmenopausal period, hot flashes are frequent symptoms and might impact quality of life. Vitamin D deficiency is commonly seen in this period. This study aims to assess the association between vitamin D deficiency and hot flashes.
METHODS


Two hundred ten postmenopausal women were recruited. The participants were divided into two groups: Group 1 consisted of postmenopausal women with hot flashes (n = 104), and Group 2 included the participants without hot flashes (n = 106).
RESULTS


The comparison of the two groups concerning vitamin D level showed that 52 patients Group 1 had vitamin 25(OH)D levels below 20 ng/mL, whereas only 25 patients in Group 2 (p < 0.001). After adjusting for age and menopause duration, there was also a significant difference between groups (21.65 vs. 34.17, respectively, p < 0.001). In multiple regression analysis, one unit decrease of vitamin 25(OH)D (1 - 0.941 = 0.059) increased the risk of hot flashes by 5.9%.
CONCLUSIONS


The decreases of vitamin D levels were significantly associated with hot flashes in postmenopausal women independent of age and menopause duration.",2020,"In multiple regression analysis, one unit decrease of vitamin 25(OH)D (1 - 0.941 = 0.059) increased the risk of hot flashes by 5.9%.
",['Two hundred ten postmenopausal women were recruited'],['postmenopausal women with hot flashes'],"['vitamin D levels', 'vitamin 25(OH)D', 'vitamin 25(OH)D levels', 'risk of hot flashes', 'vitamin D level', 'Vitamin D and Vasomotor Symptoms']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",210.0,0.0917367,"In multiple regression analysis, one unit decrease of vitamin 25(OH)D (1 - 0.941 = 0.059) increased the risk of hot flashes by 5.9%.
","[{'ForeName': 'Tufan', 'Initials': 'T', 'LastName': 'Arslanca', 'Affiliation': ''}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Korkmaz', 'Affiliation': ''}, {'ForeName': 'S Banu', 'Initials': 'SB', 'LastName': 'Arslanca', 'Affiliation': ''}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Pehlivanoglu', 'Affiliation': ''}, {'ForeName': 'Özgül', 'Initials': 'Ö', 'LastName': 'Celikel', 'Affiliation': ''}]",Clinical laboratory,['10.7754/Clin.Lab.2019.191116']
2231,32652969,Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan (2017-18): a randomized controlled trial.,"BACKGROUND


Inability to track children's vaccination history coupled with parents' lack of awareness of vaccination due dates compounds the problem of low immunization coverage and timeliness in developing countries. We evaluated the impact of two types of silicone immunization reminder bracelets for children in improving immunization coverage and timeliness of Pentavalent-3 and the Measles-1 vaccines.
METHODS


Children < 3 months were enrolled in either of the 2 intervention groups (Alma Sana Bracelet Group and Star Bracelet Group) or the Control group. Children in the intervention groups were provided the two different bracelets at the time of recruitment. Each time the child visited the immunization center, a hole was perforated in the silicone bracelet to denote vaccine administration. Each child was followed up till administration of Measles-1 vaccine or till 12 months of age (if they did not come to the center for vaccination). Data was analyzed using the intention-to-treat population between groups. The unadjusted and adjusted Risk Ratios (RR) and 95% confidence interval (CI) for Pentavalent-3 and Measles-1 coverage at 12 months of age were estimated through bivariate and multivariate analysis. Time-to-Pentavalent-3 and Measles-1 immunization curves were calculated using the Kaplan-Meier method.
RESULTS


A total of 1,445 children were enrolled in the study between July 19, 2017 and October 10, 2017. Baseline characteristics among the three groups were similar. Up-to-date coverage for the Pentavalent-3 /Measles-1 vaccine at 12 months of age was 84.6%/72.0%, 85.4%/70.5% and 83.0%/68.5% in Alma Sana Bracelet group, Star Bracelet group and Control group respectively but the differences were not statistically significant. In the multivariate analysis, neither the Alma Sana bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06), (adjusted RR: 1.05; 95% CI: 0.97-1.13) nor the Star bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06) (adjusted RR: 1.03; 95% CI: 0.95-1.11) was significantly associated with Pentavalent-3 vaccination or Measles-1 vaccination.
CONCLUSION


Although we did not observe any significant impact of the bracelets on improved immunization coverage and timeliness, our findings add to the existing literature on innovative, low cost reminders for health and make several suggestions for enhancing practical implementation of these tools.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03310762 . Retrospectively Registered on October 16, 2017.",2020,"In the multivariate analysis, neither the Alma Sana bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06), (adjusted RR: 1.05; 95% CI: 0.97-1.13) nor the Star bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06) (adjusted RR: 1.03; 95% CI: 0.95-1.11) was significantly associated with Pentavalent-3 vaccination or Measles-1 vaccination.
","['Children <\u20093\u2009months were enrolled in either of the 2', 'routine childhood immunization coverage and timeliness in urban Pakistan (2017-18', '1,445 children were enrolled in the study between July 19, 2017 and October 10, 2017']","['intervention groups (Alma Sana Bracelet Group and Star Bracelet Group) or the Control group', 'vaccine reminder and tracker bracelets']","['unadjusted and adjusted Risk Ratios (RR) and 95% confidence interval (CI) for Pentavalent-3 and Measles-1 coverage', 'Star bracelet', 'Time-to-Pentavalent-3 and Measles-1 immunization curves']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0857209', 'cui_str': 'Routine childhood immunization'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0075451', 'cui_str': 'succinyl-trialanine-4-nitroanilide'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",1445.0,0.179193,"In the multivariate analysis, neither the Alma Sana bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06), (adjusted RR: 1.05; 95% CI: 0.97-1.13) nor the Star bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06) (adjusted RR: 1.03; 95% CI: 0.95-1.11) was significantly associated with Pentavalent-3 vaccination or Measles-1 vaccination.
","[{'ForeName': 'Danya Arif', 'Initials': 'DA', 'LastName': 'Siddiqi', 'Affiliation': 'IRD Global, 15 Beach Road #02-01, Singapore, 189677, Singapore. danya.arif@ird.global.'}, {'ForeName': 'Rozina Feroz', 'Initials': 'RF', 'LastName': 'Ali', 'Affiliation': 'IRD Pakistan, 4th Floor Woodcraft Building, Korangi Creek, Karachi, 75190, Pakistan.'}, {'ForeName': 'Mehr', 'Initials': 'M', 'LastName': 'Munir', 'Affiliation': 'IRD Pakistan, 4th Floor Woodcraft Building, Korangi Creek, Karachi, 75190, Pakistan.'}, {'ForeName': 'Mubarak Taighoon', 'Initials': 'MT', 'LastName': 'Shah', 'Affiliation': 'IRD Pakistan, 4th Floor Woodcraft Building, Korangi Creek, Karachi, 75190, Pakistan.'}, {'ForeName': 'Aamir Javed', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'IRD Global, 15 Beach Road #02-01, Singapore, 189677, Singapore.'}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Chandir', 'Affiliation': 'IRD Global, 15 Beach Road #02-01, Singapore, 189677, Singapore.'}]",BMC public health,['10.1186/s12889-020-09088-4']
2232,32652972,"Rationale, design, and methods of electroencephalography-based investigation of the effects of oral desmopressin on improving slow-wave sleep time in nocturnal polyuria patients (the DISTINCT study): protocol for a single-arm, open-label, single-assignment trial.","BACKGROUND


Nocturia is one of the most bothersome lower urinary tract symptoms and often impairs sleep quality in the elderly. Although previous studies on nocturia have indicated that the successful treatment of nocturia improves sleep quality, most used questionnaires and activity devices to analyze sleep/wake patterns. Therefore, there is little information about the treatment effects of desmopressin on objective sleep quality. The aim of the DISTINCT study is to investigate the change in subjective and objective sleep quality using electroencephalography (EEG) and the Pittsburgh Sleep Quality Index (PSQI) after the administration of desmopressin in patients with nocturia due to nocturnal polyuria.
METHODS


A total of 20 male patients, ≥65 years old, with nocturnal polyuria, defined as a nocturnal polyuria index (NPi) (nocturnal urine volume / 24 h urine volume) value ≥0.33, will participate in this study. The participants must have a nocturnal frequency of ≥2 and the first uninterrupted sleep period (FUSP) must occur within < 2.5 h. Desmopressin 50 μg per day will be orally administered before going to bed for 4 weeks. Urinary frequency volume charts (FVC) and EEG will be recorded prior to treatment and at 1 week and 4 weeks after the initiation of treatment. The PSQI will be completed before and 4 weeks after treatment. The primary endpoint is the change from baseline in the mean time of slow-wave sleep (sleep stages N3 and N4) at 4 weeks. The secondary endpoints include the change in the mean value of each sleep variable, the mean delta power during the FUSP, the correlation between nocturnal urinary frequency and slow-wave sleep time, and the change in PSQI score before and after treatment.
DISCUSSION


The DISTINCT study will provide valuable evidence to indicate that oral desmopressin treatment for nocturnal polyuria prolongs the FUSP, resulting in the extension of slow-wave sleep time associated with sleep quality.
TRIAL REGISTRATION


The Japan Registry of Clinical Trials ( jRCTs051190080 ). Registered 9 December, 2019.",2020,"A total of 20 male patients, ≥65 years old, with nocturnal polyuria, defined as a nocturnal polyuria index (NPi) (nocturnal urine volume / 24 h urine volume) value ≥0.33, will participate in this study.","['20 male patients, ≥65\u2009years old, with nocturnal polyuria, defined as a nocturnal polyuria index (NPi) (nocturnal urine volume / 24\u2009h urine volume) value ≥0.33', 'patients with nocturia due to nocturnal polyuria', 'nocturnal polyuria patients']","['electroencephalography (EEG', 'oral desmopressin', 'desmopressin']","['Urinary frequency volume charts (FVC) and EEG', 'objective sleep quality', 'mean time of slow-wave sleep (sleep stages N3 and N4', 'Pittsburgh Sleep Quality Index (PSQI', 'change in the mean value of each sleep variable, the mean delta power during the FUSP, the correlation between nocturnal urinary frequency and slow-wave sleep time, and the change in PSQI score', 'slow-wave sleep time']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0848232', 'cui_str': 'Nocturnal polyuria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C4324586', 'cui_str': 'Nocturnal urinary frequency'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}]",20.0,0.0339598,"A total of 20 male patients, ≥65 years old, with nocturnal polyuria, defined as a nocturnal polyuria index (NPi) (nocturnal urine volume / 24 h urine volume) value ≥0.33, will participate in this study.","[{'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8522, Japan. torimoto@naramed-u.ac.jp.'}, {'ForeName': 'Makito', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Aoki', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8522, Japan.'}]",BMC urology,['10.1186/s12894-020-00668-5']
2233,32652973,Metformin and insulin treatment of gestational diabetes: effects on inflammatory markers and IGF-binding protein-1 - secondary analysis of a randomized controlled trial.,"BACKGROUND


Gestational diabetes mellitus (GDM) is characterized by disturbed glucose metabolism and activation of low-grade inflammation. We studied whether metformin treatment has favorable or unfavorable effects on inflammatory markers and insulin-like growth factor-binding protein 1 (IGFBP-1) in GDM patients compared with insulin, and whether these markers associate with major maternal or fetal clinical outcomes.
METHODS


This is a secondary analysis of a previous randomized controlled trial comparing metformin (n = 110) and insulin (n = 107) treatment of GDM. Fasting serum samples were collected at the time of diagnosis (baseline, mean 30 gestational weeks [gw]) and at 36 gw. Inflammatory markers serum high-sensitivity CRP (hsCRP), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and glycoprotein acetylation (GlycA) as well as three IGFBP-1 phosphoisoform concentrations were determined.
RESULTS


In the metformin and insulin groups combined, hsCRP decreased (p = 0.01), whereas IL-6 (p = 0.002), GlycA (p < 0.0001) and all IGFBP-1 phosphoisoforms (p < 0.0001) increased from baseline to 36 gw. GlycA (p = 0.02) and non-phosphorylated IGFBP-1 (p = 0.008) increased more in patients treated with metformin than those treated with insulin. Inflammatory markers did not clearly associate with pregnancy outcomes but non-phosphorylated IGFBP-1 was inversely associated with gestational weight gain.
CONCLUSIONS


Metformin had beneficial effects on maternal serum IGFBP-1 concentrations compared to insulin, as increased IGFBP-1 related to lower total and late pregnancy maternal weight gain. GlycA increased more during metformin treatment compared to insulin. The significance of this observation needs to be more profoundly examined in further studies. There were no evident clinically relevant relations between inflammatory markers and pregnancy outcome measures.
TRIAL REGISTRATION


The trial comparing metformin and insulin treatment was registered in ClinicalTrials.gov ( NCT01240785 ) November 3, 2010. Retrospectively registered.",2020,"Inflammatory markers did not clearly associate with pregnancy outcomes but non-phosphorylated IGFBP-1 was inversely associated with gestational weight gain.
","['gestational diabetes', 'Gestational diabetes mellitus (GDM']","['insulin', 'Metformin', 'insulin (n\u2009=\u2009107) treatment of GDM', 'metformin']","['hsCRP', 'Inflammatory markers', 'maternal serum IGFBP-1 concentrations', 'Inflammatory markers serum high-sensitivity CRP (hsCRP), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and glycoprotein acetylation (GlycA', 'IGFBP-1 phosphoisoforms', 'GlycA', 'Fasting serum samples', 'IL-6', 'gestational weight gain', 'non-phosphorylated IGFBP-1']","[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0172956', 'cui_str': 'Neutrophil collagenase'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",,0.166366,"Inflammatory markers did not clearly associate with pregnancy outcomes but non-phosphorylated IGFBP-1 was inversely associated with gestational weight gain.
","[{'ForeName': 'Mikael S', 'Initials': 'MS', 'LastName': 'Huhtala', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014, Turku, Finland. misahu@utu.fi.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tertti', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014, Turku, Finland.'}, {'ForeName': 'Juuso', 'Initials': 'J', 'LastName': 'Juhila', 'Affiliation': 'Medix Biochemica, Klovinpellontie 3, 02180, Espoo, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Sorsa', 'Affiliation': 'Department of Oral and Maxillofacial Diseases, Head and Neck Center, University of Helsinki and Helsinki University Hospital, P.O. Box 63, 00014, Helsinki, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku, 20014, Turku, Finland.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03077-6']
2234,32652987,Does a home-based interview with a chronically ill patient help medical students become more patient-centred? A randomised controlled trial.,"BACKGROUND


While patient-centred care improves patient outcomes, studies have shown that medical students become less patient-centred with time, so it is crucial to devise interventions that prevent this. We sought to determine whether first-year medical students who had a structured home-based interview with a chronically ill patient became more patient-centred than those who had a sham intervention.
METHODS


This randomised controlled trial assigned first-year students from the University of Bern, Switzerland, to either an interview with a chronically ill patient at the patient's home or to a sham comparator. We used the PPOS-D12 questionnaire to measure students' levels of patient-centredness at baseline, and changes in these levels during their longitudinal primary care clerkship.
RESULTS


A total of 317 students participated. Patient-centred attitudes increased during the study. A home-based interview with a chronically ill patient had no additional effect. Being female and having been exposed to patients before medical school were associated with being more patient-centred at baseline. Students were less patient-centred than their General Practitioner teachers.
CONCLUSIONS


A structured, home-based interview with a chronically ill patient did not change students' patient-centred attitudes, so cannot be recommended as a way to influence those attitudes. However, patient-centred attitudes increased during the students' first year of study, possibly because of their longitudinal primary care clerkship.
TRIAL REGISTRATION


Clinicaltrials.gov reference: NCT03722810 , registered 29th October 2018.",2020,"CONCLUSIONS


A structured, home-based interview with a chronically ill patient did not change students' patient-centred attitudes, so cannot be recommended as a way to influence those attitudes.","['317 students participated', ""year students from the University of Bern, Switzerland, to either an interview with a chronically ill patient at the patient's home or to a sham comparator"", 'first-year medical students who had a structured home-based interview with a chronically ill patient became more patient-centred than those who had a sham intervention']",[],['Patient-centred attitudes'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",317.0,0.0668715,"CONCLUSIONS


A structured, home-based interview with a chronically ill patient did not change students' patient-centred attitudes, so cannot be recommended as a way to influence those attitudes.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. michael.harris@biham.unibe.ch.'}, {'ForeName': 'Anna-Lea', 'Initials': 'AL', 'LastName': 'Camenzind', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Fankhauser', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Streit', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hari', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}]",BMC medical education,['10.1186/s12909-020-02136-y']
2235,32653012,Effects of high-protein diet combined with exercise to counteract frailty in pre-frail and frail community-dwelling older adults: study protocol for a three-arm randomized controlled trial.,"BACKGROUND


The proportion of older citizens is increasing worldwide. A well-known syndrome in old age is physical frailty which is associated with a greater risk of disabilities in activities of daily living, greater reliance on in-home services, hospitalization, institutionalization, and premature mortality. The purpose of this study is to determine the effects of an intervention with high-protein diet alone or in combination with power training in pre-frail and frail old adults.
METHODS


The study is a community-based assessor-blinded parallel randomized controlled trial (RCT), consisting of two phases. Phase 1 is a 1-month stabilization phase, where self-reliant community-dwelling adults + 80 years old will receive individual guidance regarding protein intake, to prevent the risk of negative protein balance prior to phase 2 and to only include participants who have reached the minimum recommended level of protein intake (1.0 g/kg/day) in the randomized controlled trial. Phase 2 is a 4-month RCT where 150 participants will be randomized into the following three arms: protein-only where participants will be provided with dairy products to increase their protein intake to 1.5 g/kg/day, protein + exercise where participants will be provided with the protein intervention in combination with power training two times a week, and recommendation group where participants will continue as in phase 1. Primary outcome is lower leg muscle power. Secondary outcomes include physical function and mobility, frailty status, muscle mechanical function, body composition, nutritional status, and health-related quality of life. The statistical analysis will include an intention-to-treat analysis of all randomized participant and per-protocol analysis of all compliant participants. The study hypothesis will be tested with mixed linear models to assess changes in the main outcomes over time and between study arms.
DISCUSSION


The finding of this study may add to the knowledge about the beneficial effects of high-protein diet from dairy products combined with power training to counteract frailty in community-dwelling older adults. This may ultimately have an impact on the ability to live well and independent for longer.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03842579 . Registered on 15 February 2019, version 1.",2020,"Secondary outcomes include physical function and mobility, frailty status, muscle mechanical function, body composition, nutritional status, and health-related quality of life.","['150 participants', 'community-dwelling older adults', 'self-reliant community-dwelling adults +\u200980\u2009years old', 'pre-frail and frail old adults', 'pre-frail and frail community-dwelling older adults']","['intervention with high-protein diet alone or in combination with power training', 'protein + exercise', 'high-protein diet combined with exercise', 'power training']","['lower leg muscle power', 'physical function and mobility, frailty status, muscle mechanical function, body composition, nutritional status, and health-related quality of life']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",150.0,0.0998635,"Secondary outcomes include physical function and mobility, frailty status, muscle mechanical function, body composition, nutritional status, and health-related quality of life.","[{'ForeName': 'Sussi F', 'Initials': 'SF', 'LastName': 'Buhl', 'Affiliation': 'Centre for Active and Healthy Ageing, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark. sbuhl@health.sdu.dk.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Beck', 'Affiliation': 'Department of Nutrition and Health, University College Copenhagen, Sigurdsgade 26, DK-2200, Copenhagen N, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Arla Foods amba, Global Nutrition, Agro Food Park 19, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caserotti', 'Affiliation': 'Centre for Active and Healthy Ageing, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.'}]",Trials,['10.1186/s13063-020-04572-z']
2236,32634172,Optimal paramedic numbers in resuscitation of patients with out-of-hospital cardiac arrest: A randomized controlled study in a simulation setting.,"BACKGROUND


The effect of paramedic crew size in the resuscitation of patients with out-of-hospital cardiac arrest (OHCA) remains inconclusive. We hypothesised that teams with a larger crew size have better resuscitation performance including chest compression fraction (CCF), advanced life support (ALS), and teamwork performance than those with a smaller crew size.
METHODS


We conducted a randomized controlled study in a simulation setting. A total of 140 paramedics from New Taipei City were obtained by stratified sampling and were randomly allocated to 35 teams with crew sizes of 2, 3, 4, 5, and 6 (i.e. 7 teams in every paramedic crew size). A scenario involving an OHCA patient who experienced ventricular fibrillation and was attached to a cardiopulmonary resuscitation (CPR) machine was simulated. The primary outcome was the overall CCF; the secondary outcomes were the CCF in manual CPR periods, time from the first dose of epinephrine until the accomplishment of intubation, and teamwork performance. Tasks affecting the hands-off time during CPR were also analysed.
RESULTS


In all 35 teams with crew sizes of 2, 3, 4, 5, and 6, the overall CCFs were 65.1%, 64.4%, 70.7%, 72.8%, and 71.5%, respectively (P = 0.148). Teams with a crew size of 5 (58.4%, 61.8%, 68.9%, 72.4%, and 68.7%, P<0.05) had higher CCF in manual CPR periods and better team dynamics. Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics. Troubleshooting of M-CPR machine decreased the hands-off time during resuscitation (39 s), with teams comprising 2 paramedics having the longest hands-off time (63s).
CONCLUSION


Larger paramedic crew size (≧4 paramedics) did not significantly increase the overall CCF in OHCA resuscitation but showed higher CCF in manual CPR period before the setup of the CPR machine. A crew size of ≧4 paramedics can also shorten the time of ALS interventions, while teams with 5 paramedics will have the best teamwork performance. Paramedic teams with a smaller crew size should focus more on the quality of manual CPR, teamwork, and training how to troubleshoot a M-CPR machine.",2020,"Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics.","['A total of 140 paramedics from New Taipei City', 'patients with out-of-hospital cardiac arrest (OHCA', 'patients with out-of-hospital cardiac arrest']","['M-CPR machine', 'epinephrine']","['overall CCF', 'chest compression fraction (CCF), advanced life support (ALS), and teamwork performance', 'CCF in manual CPR periods, time from the first dose of epinephrine until the accomplishment of intubation, and teamwork performance', 'overall CCFs', 'overall CCF in OHCA resuscitation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",140.0,0.0659625,"Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics.","[{'ForeName': 'Bing Min', 'Initials': 'BM', 'LastName': 'Tsai', 'Affiliation': 'Division of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Jen-Tang', 'Initials': 'JT', 'LastName': 'Sun', 'Affiliation': 'Department of Emergency Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Ming-Ju', 'Initials': 'MJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Yu-You', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'Division of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Tsung-Chi', 'Initials': 'TC', 'LastName': 'Kao', 'Affiliation': 'Division Chief of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Lee-Wei', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Institute of Emergency and Critical Care Medicine, National Yang Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Matthew Huei-Ming', 'Initials': 'MH', 'LastName': 'Ma', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Wen-Chu', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}]",PloS one,['10.1371/journal.pone.0235315']
2237,32640411,"The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study.","BACKGROUND


Nested within a large, multicenter randomized controlled trial (RCT) for people with dissociative seizures (DS), the study used purposive sampling to explore participants' experience of participating in an RCT, their experience of DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC) and their perceptions of and reflections on seizure management and change.
METHODS


A qualitative study using semistructured interviews was conducted with 30 participants in an RCT (the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) Trial) investigating the effectiveness of two treatments for DS. Key themes and subthemes were identified using thematic framework analysis (TFA).
RESULTS


Analysis yielded three overarching themes: taking part in a treatment trial - ""the only thing out there"", the experience of treatment techniques that were perceived to help with seizure management, and reflections on an ""unpredictable recovery"".
CONCLUSIONS


People with DS are amenable to participating in a psychotherapy RCT and described a largely positive experience. They also described the applicability of aspects of DS-specific CBT and SMC in the management of their DS, received within the confines of the CODES trial. Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.",2020,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","['participants with dissociative seizures', 'adults with Dissociative non-Epileptic Seizures (CODES) Trial', '30 participants in an', 'people with dissociative seizures (DS']","['DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC', 'RCT (the COgnitive behavioral therapy vs standardized medical care']",[],"[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3495874', 'cui_str': 'Non-Epileptic Seizures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]",[],30.0,0.0596229,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Read', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Jordan', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Purnell', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: laura.goldstein@kcl.ac.uk.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107230']
2238,32641094,"Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial.","BACKGROUND


The World Health Organization initiated test, treat, and track (T3) malaria strategy to support malaria-endemic countries in their efforts to achieve universal coverage with diagnostic testing, antimalarial treatment, and strengthening surveillance systems. Unfortunately, T3 is not adopted by over-the-counter medicine sellers (OTCMS) where many patients with malaria-like symptoms first seek treatment. Sub-Saharan African countries are considering introducing and scaling up RDTs in these outlets to reduce malaria burden. In this context, this study is aimed at improving implementation of the T3 among OTCMS using a number of intervention tools that could be scaled-up easily at the national level.
METHODS/DESIGN


The interventions will be evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana. A total of 8 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities will participate in the study. In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately. Supervision, technical assistance, feedbacks, and collection of data will be provided on a regular basis at the participating medicine stores. The primary outcome is the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT) before treatment. Secondary outcomes will include adherence to national malaria treatment guidelines and recommended mRDT retail price. Outcomes will be measured using mainly a household survey supplemented by mystery client survey and a surveillance register on malaria tests conducted by the OTCMS during patient consultations. Data collected will be double entered and verified using Microsoft Access 2010 (Microsoft Inc., Redmond, Washington) and analyzed using STATA version 11.0.
DISCUSSION


The trial will provide evidence on the combined effectiveness of provider and community interventions in improving adherence to the T3 initiative among OTCMS in rural Ghana.
ETHICAL CLEARANCE


NMIMR-IRB CPN 086/18-19 TRIAL REGISTRATION: ISRCTN registry ISRCTN77836926 . Registered on 4 November 2019.",2020,"In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately.","['some rural communities of Fanteakwa North district, Ghana', '8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana']","['track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS', 'provider and community interventions', 'subsidized malaria rapid diagnostic test (mRDT) kits', 'OTCMS']","['adherence to national malaria treatment guidelines and recommended mRDT retail price', 'proportion of children under 10\u2009years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",8.0,0.164506,"In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately.","[{'ForeName': 'Olajoju Temidayo', 'Initials': 'OT', 'LastName': 'Soniran', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Abuaku', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana. babuaku@noguchi.ug.edu.gh.'}, {'ForeName': 'Collins Stephen', 'Initials': 'CS', 'LastName': 'Ahorlu', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.'}]",Trials,['10.1186/s13063-020-04509-6']
2239,32641096,Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial.,"BACKGROUND


Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques mainly consist in anterior colporraphy and vaginal patch plastron. However, success rates of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. To date, high-quality data comparing vaginal native tissue procedures are still lacking.
METHODS


Herein we aimed to describe the design of the first randomized controlled trial (TAPP) comparing anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support anchored on the tendinous arch of the pelvic fascia by lateral sutures) techniques. Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional. The primary endpoint will be the success rate 1 year after surgery with a composite of objective and subjective measures (Aa and Ba points < 0 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment).
DISCUSSION


A prospective study has found a success rate at 35% for anterior colporraphy based on a combined definition, both anatomic and functional, as recently recommended. However, the definition of anatomic was strict (POP-Q< 2), while it seems that the best definition of anatomic success is ""no prolapse among the hymen"", that is to say Aa and Ba points from the POP-Q classification < 0. We hypothesize that vaginal patch plastron will have a better anatomic and functional success comparatively to anterior colporraphy because native tissue is added, as it corrects both median and lateral cystoceles thanks to bilateral paravaginal suspension.
TRIAL REGISTRATION


CHU LIMOGES is the sponsor of this research (n°87RI18_0013). This research is supported by the French Department of Health (PHRC 2018-A03476-49) and will be conducted with the support of DGOS (PHRC interregional - GIRCI SOHO). The study protocol was approved by the Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019. The trial is registered in the ClinicalTrials.gov registry ( NCT03875989 ).",2020,Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional.,"['Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019']","['anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support', 'vaginal native tissue repair']",['success rate 1\u2009year after surgery with a composite of objective and subjective measures (Aa and Ba points\u2009<\u20090 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C0447612', 'cui_str': 'Vaginal wall'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.141485,Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lacorre', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France. aymlacorre@hotmail.fr.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vidal', 'Affiliation': 'Pôle Femme Mère Couple, Hôpital Paule de Viguier, CHU Purpan, 330 avenue de Grande Bretagne, 31059, Toulouse, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Campagne-Loiseau', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Clermont-Ferrand Estaing, 1 place Lucie Aubrac, 63100, Clermont-Ferrand, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Marin', 'Affiliation': 'Institute of Neurological Epidemiology and Tropical Neurology, Faculté de Médecine de Limoges, 2 rue du Docteur Marcland, 87025, Limoges, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Aubard', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Siegerth', 'Affiliation': 'Department of Gynecology and Obstetrics, Hôpital de Tulle, 3 place Maschat, 19000, Tulle, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mesnard', 'Affiliation': 'Department of Gynecology and Obstetrics, Hôpital de Brive-La-Gaillarde, 3 boulevard Dr Verlhac, 19100, Brive-La-Gaillarde, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chantalat', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Toulouse Rangueil, 1 avenue du Professeur Jean Poulhès, 31400, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hocke', 'Affiliation': ""Department of Gynecology and Obstetrics, CHU Bordeaux Pellegrin, Centre Aliénor d'Aquitaine, Place Amélie Raba Léon, 33076, Bordeaux, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gauthier', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France.'}]",Trials,['10.1186/s13063-020-04512-x']
2240,32641097,The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial.,"BACKGROUND


The utility of patient screening logs and their impact on improving trial recruitment rates are unclear. We conducted a retrospective exploratory analysis of screening data collected within a multicentre randomised controlled trial investigating chemotherapy for upper tract urothelial carcinoma.
METHODS


Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC). Sites recorded the number of patients ineligible, not approached, declined and randomised. The CTC monitored proportions of eligible patients, approach rate (proportion of eligible patients approached) and acceptance rate (proportion recruited of those approached). Data were retrospectively analysed to identify patterns of screening activity and correlation with recruitment.
RESULTS


Data were collected between May 2012 and August 2016, during which time 71 sites were activated-a recruitment period of 2768 centre months. A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received. A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation. The approach rate was 91% (344/380), and the acceptance rate was 40% (137/344); these rates remained consistent throughout the data collection. The main reason patients provided for declining (99/207, 48%) was not wanting to receive chemotherapy. There was a moderately strong correlation (r = 0.47) between the number reported on screening logs and the number recruited per site. Considerable variation in data between centres was observed, and 54/191 trial participants (28%) enrolled during this period were not reported on logs.
CONCLUSIONS


Central collection of screening logs can identify reasons for patients declining trial participation and help monitor trial activity at sites; however, obtaining complete data can be challenging. There was a correlation between the number of patients reported on logs and recruitment; however, this was likely confounded by sites' available patient population. The use of screening logs may not be appropriate for all trials, and their use should be carefully considered in relation to the associated workload. No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.
TRIAL REGISTRATION


ISRCTN98387754 . Registered on 31 January 2012.",2020,"No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.
","['A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation', 'A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received', '54/191 trial participants (28%) enrolled during this period were not reported on logs', 'upper tract urothelial carcinoma', 'Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC']",['chemotherapy'],"['approach rate', 'acceptance rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",1138.0,0.424434,"No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK. Rebecca.Lewis@icr.ac.uk.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Newton', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Institute of Cancer Sciences, Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Bryan', 'Affiliation': 'Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04559-w']
2241,32641101,"Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.","BACKGROUND


Autoimmune encephalitis is a new spectrum of autoimmune disorders of the central nervous system (CNS), which are characterized by pathogenic autoantibodies against neuronal surface antigens. Clinical presentations range from acute to subacute encephalopathy with neurological and psychiatric symptoms, and life-threatening autonomic dysfunction in severe cases. There exist no approved therapies nor is data available from controlled clinical trials. Patients are usually treated with diverse combinations of immunotherapy. However, effect of immunotherapy on antibody-producing cells and thus on levels of pathogenic autoantibodies is insufficient. Therefore, therapeutic response is sometimes prolonged with necessity of long-time intensive care treatment and also irreversible deficits occur in severe cases. This trial will investigate the efficacy and safety of bortezomib, a proteasome inhibitor known to selectively deplete plasma cells, in patients with severe autoimmune encephalitis who have been treated with rituximab with insufficient response.
METHODS


Generate-Boost is an investigator-initiated, multicenter, double-blinded, randomized controlled phase II trial which will be conducted in specialized neurological hospitals within the GENERATE (GErman NEtwork for Research on AuToimmune Encephalitis) network in Germany. Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3), autoantibodies against neuronal surface antigens, and pretreatment with rituximab are eligible for study participation. Fifty patients will be randomized 1:1 and undergo up to 3 cycles (each 21 days with 4 s. c. applications) of bortezomib or placebo. All patients will receive concomitant medication with dexamethasone, acyclovir and co-trimoxazole. The primary efficacy endpoint is the mRS score 17 weeks after first treatment application. Secondary endpoints are neurocognitive function, antibody titers, markers of neuronal cell damage, length of ICU/hospital stay, and mRS and Glasgow coma scale scores throughout the trial up to week 17. General and bortezomib-specific adverse events are monitored continuously.
DISCUSSION


The expected outcome of the study is to obtain first reliable data on a hypothesis-driven therapeutic option in severe and difficult-to-treat autoimmune encephalitis. If treatment with bortezomib is beneficial in these cases, this will be the basis for implementation in the current guidelines.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT03993262 . Registered June 20, 2019; German Clinical Trials Register, DRKS00017497.",2020,"Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3)","['specialized neurological hospitals within the GENERATE (GErman NEtwork for Research on AuToimmune Encephalitis) network in Germany', 'Fifty patients', 'patients with severe autoimmune encephalitis who have been treated with rituximab with insufficient response', 'Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS\u2009≥\u20093', 'patients with severe autoimmune encephalitis']","['dexamethasone, acyclovir and co-trimoxazole', 'bortezomib', 'bortezomib or placebo', 'immunotherapy']","['neurocognitive function, antibody titers, markers of neuronal cell damage, length of ICU/hospital stay, and mRS and Glasgow coma scale scores', 'efficacy and safety', 'mRS score']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0393639', 'cui_str': 'Autoimmune encephalitis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.263428,"Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3)","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wickel', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Ha-Yeun', 'Initials': 'HY', 'LastName': 'Chung', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Platzer', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Prüss', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE) Berlin and Department of Neurology and Experimental Neurology, Charité - Universitätsmedizin Berlin, 10117, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leypoldt', 'Affiliation': 'Neuroimmunology, Institute of Clinical chemistry and Department of Neurology, University Hospital Schleswig-Holstein and Christian-Albrechts-University, Kiel, 24105, Kiel, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Günther', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Scherag', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Geis', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. Christian.Geis@med.uni-jena.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04516-7']
2242,32641330,Interventions with Music in PECTus excavatum treatment (IMPECT trial): a study protocol for a randomised controlled trial investigating the clinical effects of perioperative music interventions.,"INTRODUCTION


Pectus excavatum repair is associated with substantial postoperative pain, despite the use of epidural analgesia and other analgesic regimens. Perioperative recorded music interventions have been shown to alleviate pain and anxiety in adults, but evidence for children and adolescents is still lacking. This study protocol describes a randomised controlled trial that evaluates the effects of recorded music interventions on postoperative pain relief in children and adolescents after pectus excavatum repair.
METHODS


A multicentre randomised controlled trial was set up comparing the effects of perioperative recorded music interventions in addition to standard care with those of standard care only in patients undergoing a Nuss procedure for pectus excavatum repair. One hundred and seventy subjects (12-18 years of age) will be included in three centres in the Netherlands. Patient inclusion has started in November 2018, and is ongoing. The primary outcome is self-reported perceived pain measured on the visual analogue scale. Secondary outcomes are anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness.
ETHICS AND DISSEMINATION


This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.
TRIAL REGISTRATION NUMBER


NL6863.",2020,"The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol.","['children and adolescents after pectus excavatum repair', 'patients undergoing a Nuss procedure for pectus excavatum repair', 'One hundred and seventy subjects (12-18 years of age']","['perioperative recorded music interventions', 'recorded music interventions', 'Perioperative recorded music interventions', 'perioperative music interventions']","['postoperative pain relief', 'anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness', 'self-reported perceived pain measured on the visual analogue scale', 'pain and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016842', 'cui_str': 'Congenital pectus excavatum'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.200294,"The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol.","[{'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Billar', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands r.billar@erasmusmc.nl.""}, {'ForeName': 'A Y Rosalie', 'Initials': 'AYR', 'LastName': 'Kühlmann', 'Affiliation': 'Anaesthesiology, Saint Antonius Hospital, Nieuwegein, Utrecht, The Netherlands.'}, {'ForeName': 'J Marco', 'Initials': 'JM', 'LastName': 'Schnater', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vlot', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Jeremy J P', 'Initials': 'JJP', 'LastName': 'Tomas', 'Affiliation': ""Anaesthesiology, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Gerda W', 'Initials': 'GW', 'LastName': 'Zijp', 'Affiliation': ""Paediatric Surgery, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Rad', 'Affiliation': ""Anaesthesiology, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Sjoerd A', 'Initials': 'SA', 'LastName': 'de Beer', 'Affiliation': ""Paediatric Surgery, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.""}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Stevens', 'Affiliation': ""Anaesthesiology, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.""}, {'ForeName': 'Marten J', 'Initials': 'MJ', 'LastName': 'Poley', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'van Rosmalen', 'Affiliation': 'Biostatistics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Jeekel', 'Affiliation': 'Neuroscience, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Rene M H', 'Initials': 'RMH', 'LastName': 'Wijnen', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}]",BMJ open,['10.1136/bmjopen-2019-036380']
2243,32641332,"HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation.","INTRODUCTION


Tracheal intubation remains an everyday challenge for anaesthesiologists, even in patients without suspected difficult airways. The ideal positioning of the patient's head (flat, raised a few centimetres on a cushion in the sniffing position (SP), or raised to achieve horizontal alignment between the external acoustic meatus and the sternal angle) and the use of videolaryngoscopy remain controversial. This trial aims to compare the efficacy for orotracheal intubation of the SP or the head-elevated laryngoscopy position (HELP), which has been shown to improve laryngeal visualization and the intubation condition particularly in obese patients, in combination with a McGrath Mac videolaryngoscope whose video screen is either on or off (Video or NoVideo).
METHODS AND ANALYSIS


The HELP-VDL factorial trial is a prospective, randomised, parallel, multicentre, open study of 240 adult patients undergoing tracheal intubation under general anaesthesia. Patients will be allocated into four groups: SP-NoVideo, HELP-NoVideo, SP-Video and HELP-Video. The primary outcome is the proportion of orotracheal intubations that requires the assistance of a nurse anaesthetist. The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications. Data will be analysed on the intention-to-treat principle and a per-protocol basis.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethical Committee Ile de France V (Paris, France). Participant recruitment began on 3 July 2019. The results will be submitted for publication in peer-reviewed journals. Trial registration number NCT03987009; Pre-results.",2020,"The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications.","['240 adult patients undergoing tracheal intubation under general anaesthesia', 'obese patients', 'patient population without predictable difficulty of intubation', 'patients without suspected difficult airways']","['videolaryngoscope to facilitate orotracheal intubation', 'head-elevated laryngoscopy position', 'SP-NoVideo, HELP-NoVideo, SP-Video and HELP-Video', 'head-elevated laryngoscopy position (HELP', 'HELP-VDL']","['intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications', 'proportion of orotracheal intubations that requires the assistance of a nurse anaesthetist']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C2939167', 'cui_str': 'Intubation of esophagus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1504364', 'cui_str': 'Intubation complication'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]",240.0,0.101818,"The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications.","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anesthesiology, Hopital Foch, Suresnes, Île-de-France, France.'}, {'ForeName': 'Zoé', 'Initials': 'Z', 'LastName': 'Coppere', 'Affiliation': 'Department of Anaesthesiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, Île-de-France, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Dufour', 'Affiliation': 'Department of Anaesthesiology, Institut Mutualiste Montsouris, Paris, Île-de-France, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ouattara', 'Affiliation': 'Department of Anaesthesiology, Groupe hospitalier Paris Saint-Joseph, Paris, Île-de-France, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Trichereau', 'Affiliation': 'Research Unit, Hopital Foch, Suresnes, Île-de-France, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anesthesiology, Hopital Foch, Suresnes, Île-de-France, France m.fischler@orange.fr.'}]",BMJ open,['10.1136/bmjopen-2019-036570']
2244,32641334,Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation.,"INTRODUCTION


Primary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.
METHODS AND ANALYSIS


Mixed methods will be used: (1) design: intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.
ETHICS AND DISSEMINATION


Favourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.
TRIAL REGISTRATION NUMBER


NCT03353519; Pre-results.",2020,"After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT).",[],"[""intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life""]",[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",[],,0.13761,"After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT).","[{'ForeName': 'Maria Raisa Jessica Ryc', 'Initials': 'MRJR', 'LastName': 'Aquino', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK ra532@medschl.cam.ac.uk.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Mullis', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kreit', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Johnson', 'Affiliation': 'Leicester Diabetes Centre, University Hospital Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grant', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lim', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036879']
2245,32641335,"Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients.","INTRODUCTION


In patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine. Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a standard dialytic treatment is still very high. Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term. Various strategies aimed at preventing IDH are currently available, but there is lack of conclusive data on more integrated approaches combining different interventions.
METHODS AND ANALYSIS


This is a prospective, randomised, open-label, crossover trial (each subject will be used as his/her own control) that will be performed in two distinct phases, each of which is divided into several subphases. In the first phase, 27 HD sessions for each patient will be used, and will be aimed at the validation of a new ultrafiltration (UF) profile, designed with an ascending/descending shape, and a standard dialysate sodium concentration. In the second phase, 33 HD sessions for each patient will be used and will be aimed at evaluating the combination of different UF and sodium profiling strategies through individualised dialysate sodium concentration.
ETHICS AND DISSEMINATION


The trial protocol has been reviewed and approved by the local Institutional Ethics Committee (Comitato Etico AVEN, prot. 43391 22.10.19). The results of the trial will be presented at local and international conferences and submitted for publication to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03949088).",2020,Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term.,"['patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH', 'hypotension-prone haemodialysis patients']",[],"['severe immediate complications', 'mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0388866,Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Peyronel', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy francesco.peyronel@gmail.com.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Parenti', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Paride', 'Initials': 'P', 'LastName': 'Fenaroli', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Giuseppe Daniele', 'Initials': 'GD', 'LastName': 'Benigno', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Giovanni Maria', 'Initials': 'GM', 'LastName': 'Rossi', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Maggiore', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fiaccadori', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-036893']
2246,32641966,A Randomized Clinical Trial of Elemental Zinc Add-on Therapy on Clinical Outcomes of Patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).,"Recent studies suggest a relationship between zinc deficiency and inflammation. In the present study, we studied the effect of oral zinc supplementation on clinical improvement of chronic rhinosinusitis with nasal polyposis. In this single-blind randomized controlled trial, 44 patients with chronic rhinosinusitis with polyposis referring to ENT clinic of the Loghman Hakim hospital during 2013-2014 were randomly allocated in two groups. The treatment group (n = 28) was treated with a four-drug fixed-dose regimen (FD_FDR) consisting of oral dexamethasone (0.02 mg/kg), fluticasone nasal spray, fexophenadine 60 mg daily, montelukast 10 mg daily plus 220mg zinc sulfate capsules containing 55 mg elemental zinc, b.d., and the control group (n = 16) received the FD_FDR without supplemental zinc, for six weeks. After sixth week, two groups were compared regarding clinical outcomes based on theSNOT20 (Sinonasal outcome test) questionnaire, the general health questionnaire (SF12), the Lund-Mackay, and the Lund-Kennedy scoring systems. In the treatment group, serum zinc levels were significantly increased compared to those at the baseline (1.33 fold-increase;  p  = 0.0002). Within groups analysis revealed a significant reduction ( p  < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK). Incontrast, between groups analysis revealed no significant differences in the LM and LK. The treatment group showed a mild superiority in general health improvement compared to that of the control group. Add-on therapy with supplemental zinc sulfate was not associated with significant improvement in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). The advantage of zinc supplementation on the general health improvement of the patients with CRSwNP requires further assessments.",2019,Within groups analysis revealed a significant reduction ( p  < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK).,"['chronic rhinosinusitis with nasal polyposis', 'Patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP', 'patients with chronic rhinosinusitis with nasal polyposis (CRSwNP', '44 patients with chronic rhinosinusitis with polyposis referring to ENT clinic of the Loghman Hakim hospital during 2013-2014']","['FD_FDR without supplemental zinc', 'supplemental zinc sulfate', 'oral zinc supplementation', 'zinc supplementation', 'oral dexamethasone', 'fluticasone nasal spray, fexophenadine 60 mg daily, montelukast 10 mg daily plus 220mg zinc sulfate capsules containing 55 mg elemental zinc', 'Elemental Zinc Add-on Therapy']","['general health improvement', 'serum zinc levels', 'clinical outcomes based on theSNOT20 (Sinonasal outcome test) questionnaire, the general health questionnaire (SF12), the Lund-Mackay, and the Lund-Kennedy scoring systems', 'LM and LK']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0360577', 'cui_str': 'Fluticasone-containing product in nasal dose form'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1145935', 'cui_str': 'montelukast 10 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",44.0,0.132435,Within groups analysis revealed a significant reduction ( p  < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK).,"[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Akbari Dilmaghani', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nadereh', 'Initials': 'N', 'LastName': 'Alani', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Fazeli', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.1100767']
2247,32641967,"Effect of a Natural Eye Drop, Made of  Plantago Ovata  Mucilage on Improvement of Dry Eye Symptoms: A Randomized, Double-blind Clinical Trial.","Dry eye disease is a relatively common eye disorder associated with decrease in quality of life. In this study, efficacy of an eye drop of  Plantago ovata  mucilage on symptoms of dry eye disease was evaluated. In a randomized, double-blind, placebo-controlled clinical trial, sixty dry eye patients with ocular symptoms and total Ocular Surface Disease Index (OSDI) score of ≥12 were randomly assigned to receive either a natural ophthalmic drop, made of  Plantago ovata  mucilage or placebo 4 times a day for 6 weeks. The patients were evaluated at pretreatment (baseline), weeks 4 and 6 post-treatment. The evaluation of the efficacy and safety were conducted based on the OSDI questionnaire, the noninvasive tear film break-up time (NI-BUT) with keratograph, the Schirmer test without anesthesia, and the osmolarity test, as well as by monitoring possible adverse events. After 6 weeks, within group analysis showed a significant improvement in total OSDI score ( p  < 0.001). In addition, between group comparison revealed a significant improvement in the OSDI score of the intervention group ( p  < 0.001). Although, NI-BUT was significantly improved in the  Plantago ovata  group ( p  = 0.004), however no statistically significant difference was observed in between group analysis. There were no significant differences between two groups, or significant changes within the groups in the Schirmer test without anesthesia and the osmolarity test. No serious adverse events were reported. In conclusion,  P. ovata  mucilage is a natural, inexpensiveness, and safe lubricant polymer that could have beneficial ocular effects on subjective symptoms of the patients with dry eye disease.",2019,"There were no significant differences between two groups, or significant changes within the groups in the Schirmer test without anesthesia and the osmolarity test.","['patients with dry eye disease', 'sixty dry eye patients with ocular symptoms and total Ocular Surface Disease Index (OSDI) score of ≥12']","['Natural Eye Drop, Made of  Plantago Ovata  Mucilage', 'natural ophthalmic drop, made of  Plantago ovata  mucilage or placebo', 'placebo']","['quality of life', 'total OSDI score', 'NI-BUT', 'OSDI score', 'efficacy and safety', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C1209192', 'cui_str': 'Plantago ovata'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.268929,"There were no significant differences between two groups, or significant changes within the groups in the Schirmer test without anesthesia and the osmolarity test.","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Haji-Ali-Nili', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Khoshzaban', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Department of Iranian Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roja', 'Initials': 'R', 'LastName': 'Roja', 'Affiliation': 'Department of Traditional Pharmacy, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ashrafi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghaffari', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Department of Traditional Pharmacy, School of Traditional Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Jabarvand Behrouz', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.1100717']
2248,32641968,Comparative Study of the Effects of Chamomile ( Matricaria Chamomilla  L.) and Cabergoline on Idiopathic Hyperprolactinemia: A Pilot Randomized Controlled Trial.,"Chamomile is a fascinating plant quoted in several traditional medicine texts, which has broad-spectrum pharmacological activity and medicinal uses. The aim of this study was to assess the efficacy of chamomile syrup in reducing serum prolactin in women with idiopathic hyperprolactinemia. The study was a randomized, controlled clinical trial that was conducted on 56 women with idiopathic hyperprolactinemia for a study period of four weeks. Patients were randomly enrolled in two parallel arms and were treated by chamomile syrup at a dose of 5 mL twice daily or cabergoline tablet orally at a dose of 0.25 mg twice weekly. Serum prolactin levels were measured at baseline and the end of the 4-week study period. Any report of adverse events was also recorded. Results revealed that within the cabergoline group the reduction in the mean prolactin level was significantly greater than that of the chamomile group ( p  <0.0001). It was also found that decline in the mean prolactin level was statistically significant within the chamomile group ( p  <0.0001). Chamomile syrup seems to be effective on serum prolactin reduction in women with idiopathic hyperprolactinemia. However, studies with a larger sample size and for a longer follow-up period are recommended.",2019,Results revealed that within the cabergoline group the reduction in the mean prolactin level was significantly greater than that of the chamomile group ( p  <0.0001).,"['Idiopathic Hyperprolactinemia', 'women with idiopathic hyperprolactinemia', '56 women with idiopathic hyperprolactinemia for a study period of four weeks']","['chamomile syrup', 'Chamomile ( Matricaria Chamomilla  L.) and Cabergoline', 'cabergoline tablet', 'cabergoline']","['serum prolactin reduction', 'adverse events', 'mean prolactin level', 'Serum prolactin levels', 'serum prolactin']","[{'cui': 'C0271552', 'cui_str': 'Idiopathic hyperprolactinemia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0939806', 'cui_str': 'Matricaria recutita extract'}, {'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C1245215', 'cui_str': 'cabergoline Oral Tablet'}]","[{'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",56.0,0.043982,Results revealed that within the cabergoline group the reduction in the mean prolactin level was significantly greater than that of the chamomile group ( p  <0.0001).,"[{'ForeName': 'Marya', 'Initials': 'M', 'LastName': 'Kabiri', 'Affiliation': 'School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Bioos', 'Affiliation': 'School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mamak', 'Initials': 'M', 'LastName': 'Shariat', 'Affiliation': 'Institute of Family Health, Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Sohrabvand', 'Affiliation': 'Vali-e-Asr Hospital, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.1100758']
2249,32641970,A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Βeta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran.,"We compared the efficacy and safety of a biosimilar form of beta-interferon-1a (Actovex) versus the reference product in the treatment of relapsing remitting multiple sclerosis (RRMS). In a double blind, randomized phase 3 clinical trial, we evaluated 138 patients with RRMS that were allocated to receive the biosimilar medication and the reference treatment (30 μg intramuscular, weekly for one year). We investigated changes in EDSS, relapse rate and MRI changes within one year. In sixty-nine patients who were allocated to each arm and analyzed mean age and its standard deviation was 32.4 ± 8.8 and 31.5 ± 8 for the biosimilar medication and the reference arm respectively. One-year follow-up revealed a mean difference of 0.084 in EDSS (95% CI: 0.069-0.237) between the two groups in favor of the biosimilar medication. This value did not exceed the predefined non-inferiority margin of 0.1. There were no statistically significant differences in relapse rate and systemic and local adverse events of the two groups. The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety. In conclusion the biosimilar interferon 1-a can be considered as an effective and safe alternative to the reference product due to lower cost and more availability.",2019,The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety.,"['relapsing remitting multiple sclerosis (RRMS', 'In sixty-nine patients who were allocated to each arm and analyzed mean age and its standard deviation was 32.4 ± 8.8 and 31.5 ± 8 for the biosimilar medication and the reference arm respectively', '138 patients with RRMS']","['Biosimilar Form of Intramuscular Βeta-interferon I', 'biosimilar medication', 'biosimilar form of beta-interferon-1a (Actovex']","['efficacy and safety', 'relapse rate and systemic and local adverse events', 'EDSS, relapse rate and MRI changes']","[{'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",138.0,0.0550926,The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety.,"[{'ForeName': 'Seyed Massood', 'Initials': 'SM', 'LastName': 'Nabavi', 'Affiliation': 'Department of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Abolfazli', 'Affiliation': 'Department of Neurology, Amir Alam Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Etemadrezaei', 'Affiliation': 'Actoverco Pharmaceuticals, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Clinical Trial Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'Shefa Neuroscience Research Center, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Shahriari', 'Affiliation': 'Actoverco Pharmaceuticals, Tehran, Iran.'}, {'ForeName': 'Baharak', 'Initials': 'B', 'LastName': 'Mehdipour', 'Affiliation': 'Actoverco Pharmaceuticals, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Shekarchi', 'Affiliation': 'Department of Radiology, School of Medicine, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Soltanzadeh', 'Affiliation': 'Department of Neurology, Faculty of Medical, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.14503.12441']
2250,32643012,Comparison of the proximal and distal approaches for axillary vein catheterization under ultrasound guidance (PANDA) in cardiac surgery patients susceptible to bleeding: a randomized controlled trial.,"BACKGROUND


The present study aimed at comparing the success rate and safety of proximal versus distal approach for ultrasound (US)-guided axillary vein catheterization (AVC) in cardiac surgery patients susceptible to bleeding.
METHODS


In this single-center randomized controlled trial, cardiac surgery patients susceptible to bleeding and requiring AVC were randomized to either the proximal or distal approach group for US-guided AVC. Patients susceptible to bleeding were defined as those who received oral antiplatelet drugs or anticoagulants for at least 3 days. Success rate, catheterization time, number of attempts, and mechanical complications within 24 h were recorded for each procedure.
RESULTS


A total of 198 patients underwent randomization: 99 patients each to the proximal and distal groups. The proximal group had the higher first puncture success rate (75.8% vs. 51.5%, p < 0.001) and site success rate (93.9% vs. 83.8%, p = 0.04) than the distal group. However, the overall success rates between the two groups were similar (99.0% vs. 99.0%; p = 1.00). Moreover, the proximal group had fewer average number of attempts (p < 0.01), less access time (p < 0.001), and less successful cannulation time (p < 0.001). There was no significant difference in complications between the two groups, such as major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements.
CONCLUSIONS


For cardiac surgery patients susceptible to bleeding, both proximal and distal approaches for US-guided AVC can be considered as feasible and safe methods of central venous cannulation. In terms of the first puncture success rate and cannulation time, the proximal approach is superior to the distal approach. Trial registration Clinicaltrials.gov, NCT03395691. Registered January 10, 2018, https://clinicaltrials.gov/ct2/show/NCT03395691?cond=NCT03395691&draw=1&rank=1 .",2020,"There was no significant difference in complications between the two groups, such as major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements.
","['cardiac surgery patients susceptible to bleeding and requiring AVC', '198 patients underwent randomization: 99 patients each to the proximal and distal groups', 'cardiac surgery patients susceptible to bleeding']","['proximal and distal approaches for axillary vein catheterization under ultrasound guidance (PANDA', 'proximal versus distal approach for ultrasound (US)-guided axillary vein catheterization (AVC', 'proximal or distal approach group for US-guided AVC']","['overall success rates', 'higher first puncture success rate', 'major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements', 'Success rate, catheterization time, number of attempts, and mechanical complications within 24\xa0h', 'complications', 'successful cannulation time', 'site success rate', 'access time']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0004456', 'cui_str': 'Structure of axillary vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0004456', 'cui_str': 'Structure of axillary vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0444454', 'cui_str': 'Access'}]",198.0,0.174438,"There was no significant difference in complications between the two groups, such as major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Jun-Yi', 'Initials': 'JY', 'LastName': 'Hou', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Guo-Guang', 'Initials': 'GG', 'LastName': 'Ma', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Guang-Wei', 'Initials': 'GW', 'LastName': 'Hao', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Jing-Chao', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Shen-Ji', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Ji-Li', 'Initials': 'JL', 'LastName': 'Zheng', 'Affiliation': 'Department of Nursing, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Nursing, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China. luo.zhe@zs-hospital.sh.cn.'}, {'ForeName': 'Guo-Wei', 'Initials': 'GW', 'LastName': 'Tu', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China. tu.guowei@zs-hospital.sh.cn.'}]",Annals of intensive care,['10.1186/s13613-020-00703-6']
2251,32653055,"Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial.","BACKGROUND


Vitiligo is a chronic autoimmune disease resulting in skin depigmentation and reduced quality of life. There is no approved treatment for vitiligo repigmentation and current off-label therapies have limited efficacy, emphasising the need for improved treatment options. We investigated the therapeutic potential of ruxolitinib cream in patients with vitiligo and report the efficacy and safety results up to 52 weeks of double-blind treatment.
METHODS


We did a multicentre, randomised, double-blind, phase 2 study for adult patients with vitiligo in 26 US hospitals and medical centres in 18 states. Patients with depigmentation of 0·5% or more of their facial body surface area (BSA) and 3% or more of their non-facial BSA were randomly assigned (1:1:1:1:1) by use of an interactive response technology system to receive ruxolitinib cream (1·5% twice daily, 1·5% once daily, 0·5% once daily, or 0·15% once daily) or vehicle (control group) twice daily on lesions constituting 20% or less of their total BSA for 24 weeks. Patients in the control group in addition to patients in the 0·15% once daily group who did not show a 25% or higher improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI) at week 24 were re-randomised to one of three higher ruxolitinib cream doses (0·5% once daily, 1·5% once daily, 1·5% twice daily). Patients in the 0·5% once daily, 1·5% once daily, or 1·5% twice daily groups remained at their original dose up to week 52. Patients, investigators, and the study sponsor (except members of the interim analysis and primary endpoint analysis data monitoring teams) remained masked to treatment assignment throughout the study. The primary endpoint was the proportion of patients achieving a 50% or higher improvement from baseline in F-VASI (F-VASI50) at week 24, assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT03099304.
FINDINGS


Between June 7, 2017, and March 21, 2018, 205 patients were screened for eligibility, 48 were excluded and 157 patients (mean age, 48·3 years [SD 12·9]; 73 [46%] male and 84 [54%] female) were randomly assigned to either an intervention group or the control group. 32 (20%) of 157 were assigned to the control group, 31 (20%) to the 0·15% once daily group, 31 (20%) to the 0·5% once daily group, 30 (19%) to the 1·5% once daily group, and 33 (21%) to the 1·5% twice daily group. F-VASI50 at week 24 was reached by significantly more patients given ruxolitinib cream at 1·5% twice daily (15 [45%] of 33) and 1·5% once daily (15 [50%] of 30) than were treated with vehicle (one [3%] of 32). Four patients had serious treatment-emergent adverse events (one patient in the 1·5% twice daily group developed subdural haematoma; one patient in the 1·5% once daily group had a seizure; one patient in the 0·5% once daily group had coronary artery occlusion; and one patient in the 0·5% once daily group had oesophageal achalasia), all of which were unrelated to study treatment. Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1·5% twice daily group; three [10%] of 30 in the 1·5% once daily group; three [10%] of 31 in the 0·5% once daily group; and six [19%] of 31 in the 0·15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group. Acne was noted as a treatment-related adverse event in 13 (10%) of 125 patients who received ruxolitinib cream and one (3%) of 32 patients who received vehicle cream. All treatment-related adverse events were mild or moderate in severity and similar across treatment groups.
INTERPRETATION


Treatment with ruxolitinib cream was associated with substantial repigmentation of vitiligo lesions up to 52 weeks of treatment, and all doses were well tolerated. These data suggest that ruxolitinib cream might be an effective treatment option for patients with vitiligo.
FUNDING


Incyte.",2020,Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1·5% twice daily group; three [10%] of 30 in the 1·5% once daily group; three [10%] of 31 in the 0·5% once daily group; and six [19%] of 31 in the 0·15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group.,"['vitiligo', 'patients with vitiligo', 'adult patients with vitiligo in 26 US hospitals and medical centres in 18 states', '205 patients were screened for eligibility, 48 were excluded and 157 patients (mean age, 48·3 years [SD 12·9]; 73 [46%] male and 84 [54%] female', 'Between June 7, 2017, and March 21, 2018', 'Patients with depigmentation of 0·5% or more of their facial body surface area (BSA) and 3% or more of their non-facial BSA']","['interactive response technology system to receive ruxolitinib cream (1·5% twice daily, 1·5% once daily, 0·5% once daily, or 0·15% once daily) or vehicle (control group) twice daily on lesions constituting 20% or less of their total BSA', 'ruxolitinib cream', 'Ruxolitinib cream', 'vehicle cream']","['substantial repigmentation of vitiligo lesions', 'tolerated', 'F-VASI50', 'oesophageal achalasia', 'serious treatment-emergent adverse events', 'facial Vitiligo Area Scoring Index', 'subdural haematoma', 'proportion of patients achieving a 50% or higher improvement from baseline in F-VASI (F-VASI50', 'coronary artery occlusion']","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018946', 'cui_str': 'Subdural hematoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0151814', 'cui_str': 'Coronary occlusion'}]",205.0,0.162939,Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1·5% twice daily group; three [10%] of 30 in the 1·5% once daily group; three [10%] of 31 in the 0·5% once daily group; and six [19%] of 31 in the 0·15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosmarin', 'Affiliation': 'Tufts Medical Center, Boston, MA, USA. Electronic address: drosmarin@tuftsmedicalcenter.org.'}, {'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Pandya', 'Affiliation': 'Palo Alto Foundation Medical Group, Mountain View, CA, USA; University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Pearl', 'Initials': 'P', 'LastName': 'Grimes', 'Affiliation': 'The Vitiligo and Pigmentation Institute of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Iltefat', 'Initials': 'I', 'LastName': 'Hamzavi', 'Affiliation': 'Henry Ford Medical Center, Detroit, MI, USA.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Kuo', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ji', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Howell', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harris', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30609-7']
2252,32653074,"Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study.","BACKGROUND


Patients with asthma who are inadequately controlled on inhaled corticosteroid-long-acting β 2 -adrenoceptor agonist (ICS-LABA) combinations might benefit from the addition of a long-acting muscarinic receptor antagonist. The aim of the IRIDIUM study was to assess the efficacy and safety of a once-daily, single-inhaler combination of mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) versus ICS-LABA in patients with inadequately controlled asthma.
METHODS


In this 52-week, double-blind, double-dummy, parallel-group, active-controlled phase 3 study, patients were recruited from 415 sites across 41 countries. Patients aged 18 to 75 years with symptomatic asthma despite treatment with medium-dose or high-dose ICS-LABA, at least one exacerbation in the previous year, and a percentage of predicted FEV 1  of less than 80% were included. Enrolled patients were randomly assigned (1:1:1:1:1) via interactive response technology to receive medium-dose or high-dose MF-IND-GLY (80 μg, 150 μg, 50 μg; 160 μg, 150 μg, 50 μg) or MF-IND (160 μg, 150 μg; 320 μg, 150 μg) once daily via Breezhaler, or high-dose fluticasone-salmeterol (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus. The primary outcome was change from baseline in trough FEV 1  with MF-IND-GLY versus MF-IND at week 26 in patients in the full analysis set, analysed by means of a mixed model for repeated measures. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02571777, and is completed.
FINDINGS


Between Dec 8, 2015, and Jun 14, 2019, 3092 of 4851 patients screened were randomly assigned (medium-dose MF-IND-GLY, n=620; high-dose MF-IND-GLY, n=619; medium-dose MF-IND, n=617; high-dose MF-IND, n=618; high-dose FLU-SAL, n=618). 2747 (88·8%) patients completed the 52-week treatment and 321 (10·4%) started but discontinued study treatment prematurely. Medium-dose MF-IND-GLY (treatment difference [Δ] 76 mL [95% CI 41-111]; p<0·001) and high-dose MF-IND-GLY (Δ 65 mL [31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26. Improvements in trough FEV 1  were greater for both medium-dose MF-IND-GLY (99 mL [64-133]; p<0·001) and high-dose MF-IND-GLY (119 mL [85-154]; p<0·001) than for high-dose FLU-SAL at week 26. Overall, the incidence of adverse events was balanced across the treatment groups. Seven deaths were reported (one with medium-dose MF-IND-GLY, two with high-dose MF-IND-GLY, and four with high-dose MF-IND) during the study; none of these deaths was considered by the investigators to be caused by study drugs or other study-related factors.
INTERPRETATION


Once-daily, single-inhaler MF-IND-GLY improved lung function versus ICS-LABA combinations (MF-IND and FLU-SAL) in patients with inadequately controlled asthma. The safety profile was similar across treatment groups. MF-IND-GLY therefore constitutes a good treatment option in these patients.
FUNDING


Novartis Pharmaceuticals.",2020,[31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26.,"['2747', 'Between Dec 8, 2015, and Jun 14, 2019, 3092 of 4851 patients screened', 'Patients with asthma who are inadequately controlled on inhaled corticosteroid-long-acting β 2', 'Patients aged 18 to 75 years with symptomatic asthma despite treatment with medium-dose or high-dose ICS-LABA, at least one exacerbation in the previous year, and a percentage of predicted FEV 1  of less than 80% were included', 'patients with inadequately controlled asthma (IRIDIUM', 'patients with inadequately controlled asthma', 'patients were recruited from 415 sites across 41 countries']","['Medium-dose MF-IND-GLY', 'interactive response technology to receive medium-dose or high-dose MF-IND-GLY', 'adrenoceptor agonist (ICS-LABA', 'MF-IND', 'daily via Breezhaler, or high-dose fluticasone-salmeterol (FLU-SAL', 'mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY', 'ICS-LABA combinations (MF-IND and FLU-SAL', 'mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol', 'ICS-LABA']","['Safety', 'superior improvement in trough FEV', 'change from baseline in trough FEV 1  with MF-IND-GLY versus MF-IND', 'safety profile', 'efficacy and safety', 'adverse events']","[{'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022071', 'cui_str': 'Iridium'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1.0,0.468901,[31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26.,"[{'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, Netherlands. Electronic address: h.a.m.kerstjens@umcg.nl.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación Centro Investigacion de Enfermedades Alergicas y Respiratorias, Buenos Aires, Argentina.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Chapman', 'Affiliation': 'Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lavecchia', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Pethe', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30190-9']
2253,32653075,"Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study.","BACKGROUND


Fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and long-acting β 2 -adrenoceptor agonists (LABA) are considered safe and efficacious in asthma management. Most available FDCs require twice-daily dosing to achieve optimum therapeutic effect. The objective of the PALLADIUM study was to assess the efficacy and safety of once-daily FDC of mometasone furoate plus indacaterol acetate (MF-IND) versus mometasone furoate (MF) monotherapy in patients with inadequately controlled asthma.
METHODS


This 52-week, double-blind, triple-dummy, parallel-group, phase 3 study recruited patients from 316 centres across 24 countries. Patients aged 12 to 75 years with a documented diagnosis of asthma for at least 1 year, percentage of predicted FEV 1  of 50-85%, and an Asthma Control Questionnaire 7 score of at least 1·5 despite treatment with medium-dose or high-dose ICS or low-dose ICS plus LABA were included. A history of asthma exacerbations was not a study requirement. Participants were randomily assigned (1:1:1:1:1) via interactive response technology to receive one of the following treatments for 52 weeks: high-dose MF-IND (320 μg, 150 μg) or medium-dose MF-IND (160 μg, 150 μg) once daily via Breezhaler; high-dose MF (800 μg [400 μg twice daily]) or medium-dose MF (400 μg once daily) via Twisthaler; or high-dose fluticasone propionate-salmeterol xinafoate (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus. Participants received placebo via inhalation through the Breezhaler, Twisthaler, or Diskus devices in the mornings and evenings, as appropriate. The primary endpoint was improvement in trough FEV 1  with high-dose and medium-dose MF-IND versus respective MF doses from baseline at 26 weeks, analysed in the full analysis set by means of a mixed model for repeated measures. High-dose MF-IND once daily was compared with high-dose FLU-SAL twice daily for non-inferiority on improving trough FEV 1  at week 26 with a margin of -90 mL using mixed model for repeated measures as one of the secondary endpoints. Safety was assessed in all patients who had received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02554786, and is completed.
FINDINGS


Between Dec 29, 2015, and May 4, 2018, 2216 patients were randomly assigned (high-dose MF-IND, n=445; medium-dose MF-IND, n=439; high-dose MF, n=442; medium-dose MF, n=444; high-dose FLU-SAL, n=446), of which 1973 (89·0%) completed the study treatment and 234 (10·6%) prematurely discontinued study treatment. High-dose MF-IND (treatment difference [Δ] 132 mL [95% CI 88 to 176]; p<0·001) and medium-dose MF-IND (Δ 211 mL [167 to 255]; p<0·001) showed superiority in improving trough FEV 1  over corresponding MF doses from baseline at week 26. High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26 (Δ 36 mL [-7 to 80]; p=0·101). Overall, the incidence of adverse events was similar across the treatment groups.
INTERPRETATION


Once-daily FDC of ICS and LABA (MF-IND) significantly improved lung function over ICS monotherapy (MF) at week 26; high-dose MF-IND was non-inferior to twice-daily combination of ICS and LABA (high-dose FLU-SAL) for improvement in trough FEV 1 . The combination of MF-IND provides a novel once-daily dry powder option for asthma control.
FUNDING


Novartis Pharmaceuticals.",2020,High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26,"['Between Dec 29, 2015, and May 4, 2018', 'patients with inadequately controlled asthma ', 'Patients aged 12 to 75 years with a documented diagnosis of asthma for at least 1 year, percentage of predicted FEV 1  of 50-85%, and an Asthma Control Questionnaire 7 score of at least 1·5 despite treatment with medium-dose or high-dose ICS or low-dose ICS plus LABA were included', 'patients who had received at least one dose of study drug', '2216 patients', '3 study recruited patients from 316 centres across 24 countries', 'patients with inadequately controlled asthma']","['mometasone furoate plus indacaterol acetate (MF-IND', 'mometasone furoate (MF) monotherapy', 'MF-IND (320 μg, 150 μg) or medium-dose MF-IND (160 μg, 150 μg) once daily via Breezhaler; high-dose MF (800 μg [400 μg twice daily]) or medium-dose MF (400 μg once daily) via Twisthaler; or high-dose fluticasone propionate-salmeterol xinafoate (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus', 'mometasone plus indacaterol versus mometasone', 'inhaled corticosteroids (ICS) and long-acting', 'fluticasone plus salmeterol', 'adrenoceptor agonists (LABA', 'placebo']","['Safety', 'trough FEV 1  with high-dose and medium-dose MF-IND', 'efficacy and safety', 'superiority in improving trough FEV', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1622832', 'cui_str': 'Fluticasone Propionate-Salmeterol Xinafoate Drug Combination'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2216.0,0.644787,High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26,"[{'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: richard.vanzyl-smit@uct.ac.za.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Leipzig, Germany; POIS Leipzig, Leipzig, Germany.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Gon', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Noga', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Berlin, Germany.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Richard', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'de Los Reyes', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Pethe', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30178-8']
2254,32653082,Brainwave entrainment to minimise sedative drug doses in paediatric surgery: a randomised controlled trial.,"BACKGROUND


Anaesthetic drugs may cause neuroapoptosis in children and are routinely used off-label in specific age groups. Techniques that reduce anaesthetic drug dose requirements in children may thus enhance the safety of paediatric sedation or anaesthesia. Brainwave entrainment, notably in the form of auditory binaural beats, has been shown to have sedative effects in adults. We evaluated the influence of brainwave entrainment on propofol dose requirements for sedation in children.
METHODS


We randomised 49 boys scheduled for sub-umbilical surgery under caudal blockade to an entrainment or a control group. Small differences in pitch were applied to each ear to create binaural beats, supplemented by synchronous visual stimuli, within the electroencephalographic frequency bands seen during relaxation and (rapid eye movement/non-rapid eye movement) sleep. After establishment of caudal block, propofol infusion was started at 5 mg kg -1  h -1 . Intraoperatively, the infusion rate was adjusted every 5 min depending on the sedation state judged by the bispectral index (BIS). The infusion rate was decreased by 1 mg kg -1  h -1  if BIS was <70, and was increased if BIS was >70, heart rate increased by 20%, or if there were other signs of inadequate sedation.
RESULTS


Mean propofol infusion rates were 3.0 (95% confidence interval [CI]: 2.4-3.6) mg kg -1  h -1 vs 4.2 (95% CI: 3.6-4.8) mg kg -1  h -1  in the entrainment and control groups, respectively (P<0.01). BIS values were similar in the two groups.
CONCLUSIONS


Brainwave entrainment effectively reduced the propofol infusion rates required for sedation in children undergoing surgery with regional anaesthesia. Further studies are needed to investigate the possibility of phasing out propofol infusions completely during longer surgical procedures and optimising the settings of brainwave stimulation.
CLINICAL TRIAL REGISTRATION


DRKS00005064.",2020,"BIS values were similar in the two groups.
","['paediatric surgery', 'children undergoing surgery with regional anaesthesia', '49 boys scheduled for sub-umbilical surgery under caudal blockade to an entrainment or a control group', 'children']","['propofol infusion', 'propofol']","['Mean propofol infusion rates', 'propofol infusion rates', 'heart rate', 'BIS values', 'infusion rate']","[{'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",49.0,0.19391,"BIS values were similar in the two groups.
","[{'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmid', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: peter.marhofer@meduniwien.ac.at.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Opfermann', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zadrazil', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kimberger', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Triffterer', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Klug', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.050']
2255,32653144,Reply to the letter to the editor: Effectiveness of acupuncture on pregnancy success rates for women undergoing in vitro fertilization: A randomized controlled trial.,,2020,,['women undergoing in\xa0vitro fertilization'],['acupuncture'],['pregnancy success rates'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.11661,,"[{'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Cayir', 'Affiliation': 'Ataturk University, Research and Practice Center for Acupuncture and Complementary Therapy Modalities Erzurum, Turkey. Electronic address: dryasemincayir@yahoo.com.'}]",Taiwanese journal of obstetrics & gynecology,['10.1016/j.tjog.2020.05.029']
2256,32653539,The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.,"Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes.",2020,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","['African American adults with uncontrolled diabetes and multiple chronic health conditions', ' African American patients with uncontrolled diabetes living in medically underserved areas', 'Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability', '646 patients (n\u202f=\u202f581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC', 'African Americans individuals with uncontrolled diabetes']","['Text messaging (TM) and health coaching (HC', 'text messaging versus health coaching', 'TM and HC with enhanced usual care (EC']","['diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c', 'general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",646.0,0.105121,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Bailey', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America. Electronic address: jeb@uthsc.edu.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Surbhi', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gatwood', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Butterworth', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Q-consult, LLC, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Sohul A', 'Initials': 'SA', 'LastName': 'Shuvo', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ankur A', 'Initials': 'AA', 'LastName': 'Dashputre', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Brooks', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Surgery, Anne Arundel Medical Center, Annapolis, MD, United States of America.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Binkley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Carrie Jo', 'Initials': 'CJ', 'LastName': 'Riordan', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinberg', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of Endocrinology, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Gutierrez', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Haley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Cardella', 'Initials': 'C', 'LastName': 'Leak', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tolley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106080']
2257,32653571,Brain MR imaging and spectroscopy for outcome prognostication after pediatric cardiac arrest.,"AIM


Children surviving cardiac arrest are at high risk of neurological morbidity and mortality; however, there is a lack of validated prognostic biomarkers. We aimed to evaluate brain magnetic resonance imaging (MRI) and spectroscopy (MRS) as predictors of death and disability. Secondly, we evaluated whether MRI/S by randomized group.
METHODS


This single center study analyzed clinically indicated brain MRI/S data from children enrolled in a randomized controlled trial of 24 versus 72 hours of hypothermia following cardiac arrest. Two pediatric radiologists scored conventional MRIs. Lactate and N-acetyl-aspartate (NAA) concentrations (mmol/kg) were determined from spectra acquired from the basal ganglia, thalamus, parietal white matter and parietooccipital gray matter. Mortality and neurological outcomes (favorable = Pediatric Cerebral Performance Category [PCPC] 1, 2, 3 or increase < 2) were assessed at hospital discharge. Non-parametric tests were used to test for associations between MRI/S biomarkers and outcome and randomized group.
RESULTS


23 children with (median [interquartile range]) age of 1.5 (0.3-4.0) years. Ten (44%) had favorable outcome. There were more T2 brain lesions in the lentiform nuclei in children with unfavorable 12 (92%) versus favorable 3 (33%) outcome, p = .007. Increased lactate and decreased NAA concentrations in the parietooccipital gray matter and decreased NAA in the parietal white matter were associated with unfavorable outcome (p's<.05). There were no differences for any biomarker by randomized group.
CONCLUSION


Regional cerebral and metabolic MRI/S biomarkers are predictive of neurological outcomes at hospital discharge in pediatric cardiac arrest and should undergo validation testing in a large sample.",2020,Increased lactate and decreased NAA concentrations in the parietooccipital gray matter and decreased NAA in the parietal white matter were associated with unfavorable outcome (p's<.05).,"['pediatric cardiac arrest', '23 children with (median [interquartile range]) age of 1.5 (0.3-4.0) years', 'children enrolled in a randomized controlled trial of 24 versus 72\u2009hours of hypothermia following cardiac arrest']","['brain magnetic resonance imaging (MRI) and spectroscopy (MRS', 'Brain MR imaging and spectroscopy', 'PCPC']","['Lactate and N-acetyl-aspartate (NAA) concentrations (mmol/kg', 'Increased lactate and decreased NAA concentrations', 'Mortality and neurological outcomes', 'T2 brain lesions']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439291', 'cui_str': 'mmol/kg'}, {'cui': 'C0392691', 'cui_str': 'Increased lactic acid level'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}]",23.0,0.15601,Increased lactate and decreased NAA concentrations in the parietooccipital gray matter and decreased NAA in the parietal white matter were associated with unfavorable outcome (p's<.05).,"[{'ForeName': 'Ericka L', 'Initials': 'EL', 'LastName': 'Fink', 'Affiliation': ""Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Safar Center for Resuscitation Research, Pittsburgh, PA, USA. Electronic address: finkel@ccm.upmc.edu.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wisnowski', 'Affiliation': ""Children's Hospital of Los Angeles (Los Angeles, CA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Clark', 'Affiliation': ""Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Safar Center for Resuscitation Research, Pittsburgh, PA, USA.""}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Berger', 'Affiliation': ""Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA; Safar Center for Resuscitation Research, Pittsburgh, PA, USA.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fabio', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Furtado', 'Affiliation': ""Department of Radiology, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Srikala', 'Initials': 'S', 'LastName': 'Narayan', 'Affiliation': ""Department of Radiology, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Pittsburgh, PA USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Watson', 'Affiliation': ""Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA; Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'Emergency Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Safar Center for Resuscitation Research, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bell', 'Affiliation': ""Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Kochanek', 'Affiliation': ""Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Safar Center for Resuscitation Research, Pittsburgh, PA, USA.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bluml', 'Affiliation': ""Children's Hospital of Los Angeles (Los Angeles, CA, USA.""}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Panigrahy', 'Affiliation': ""Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA; Department of Radiology, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}]",Resuscitation,['10.1016/j.resuscitation.2020.06.033']
2258,32653577,Evaluation of platelet-rich plasma as a treatment for androgenetic alopecia: A randomized controlled trial.,"BACKGROUND


Platelet-rich plasma (PRP) shows promise as an androgenetic alopecia (AGA) treatment.
OBJECTIVE


Conduct a randomized placebo-controlled split-scalp study to investigate PRP's effects on hair regrowth and thickness.
METHODS


35 study participants with AGA had two 7.6-centimeter x 7.6-centimeter squares tattooed on their scalps. Areas were randomly assigned to intradermal injection with PRP or saline. Subjects underwent three monthly treatment sessions with evaluation three months after final treatment.
RESULTS


Hair density in the PRP-treated area was significantly increased compared to baseline at all visits. At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (p < 0.05). However, hair density in placebo-treated areas also increased from 151.04 ± 41.99 hairs/cm 2  to 166.72 ± 37.13 hairs/cm 2  (p < 0.05). There was no significant difference in hair density change between the two groups (p > 0.05). No serious adverse events were reported.
LIMITATIONS


Possible PRP diffusion due to split-scalp study design as well as microinjections causing micro-injury to both sides.
CONCLUSION


PRP may have benefit in increasing hair density.",2020,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (p < 0.05).","['35 study participants with AGA had two 7.6-centimeter x 7.6-centimeter squares tattooed on their scalps', 'androgenetic alopecia']","['intradermal injection with PRP or saline', 'platelet-rich plasma', 'placebo']","['hair regrowth and thickness', 'hair density in PRP-treated areas', 'serious adverse events', 'Hair density', 'hair density', 'hair density change']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}]","[{'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",35.0,0.0990235,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (p < 0.05).","[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'The Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York 10016. Electronic address: Jerry.Shapiro@nyulangone.org.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ho', 'Affiliation': 'The Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York 10016.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Sukhdeo', 'Affiliation': 'Pilaris Dermatology, New York, New York 10016.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'The Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York 10016.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lo Sicco', 'Affiliation': 'The Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York 10016.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.07.006']
2259,32653580,Investigation of the Effects of Dual Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomised Controlled Trial.,"OBJECTIVES


To investigate the effects of dual task balance training on static and dynamic balance, functional mobility, cognitive level, and sleep quality in individuals with transfemoral amputation.
DESIGN


Randomised controlled clinical trial.
PARTICIPANTS


Transfemoral amputees (n=20).
INTERVENTIONS


Participants were randomly assigned to the single task gait and balance training group (n=10) or the dual task task gait and balance training group (n=10). Training was given in sessions of 60 min/day, 3 days/wk for 4 weeks. The single task training group performed traditional gait and balance exercises, and the dual task training group practised cognitive and motor tasks while performing gait and balance exercises.
MAIN OUTCOME MEASURES


The one leg stance test and the four-square step test were used for balance assessment. The Timed Up and Go test, and 10-meter walk test were used for gait assessment. Three test conditions to evaluate the training effects were single walking, walking while performing a cognitive task (serial subtraction), and walking while performing a motor task (tray-carrying). The Montreal Cognitive Assessment scale was used for cognitive assessment and the Pittsburgh Sleep Quality Index for sleep quality assessment.
RESULTS


Balance and mobility improved in both groups. Dual task balance performance, functional mobility and gait speed improved more in the dual task training group after training (p <0.05). Cognitive status and sleep quality improved significantly in the dual task group (p <0.05).
CONCLUSIONS


Dual-task training was more effective than single task training in the improvement of dual task performance and cognitive status. The inclusion of dual task exercises in the rehabilitation program of transfemoral amputees will provide a different perspective due to increased task automation.",2020,"Dual task balance performance, functional mobility and gait speed improved more in the dual task training group after training (p <0.05).","['Transfemoral amputees (n=20', 'Transfemoral Amputees', 'individuals with transfemoral amputation']","['single task gait and balance training group (n=10) or the dual task task gait and balance training group', 'single task training group performed traditional gait and balance exercises, and the dual task training group practised cognitive and motor tasks while performing gait and balance exercises', 'single walking, walking while performing a cognitive task (serial subtraction), and walking while performing a motor task (tray-carrying', 'dual task balance training', 'Dual Task Balance Training', 'Dual-task training']","['Balance and mobility', 'cognitive assessment and the Pittsburgh Sleep Quality Index for sleep quality assessment', 'Gait and Balance', 'Montreal Cognitive Assessment scale', 'static and dynamic balance, functional mobility, cognitive level, and sleep quality', 'dual task performance and cognitive status', 'leg stance test and the four-square step test', 'Dual task balance performance, functional mobility and gait speed', 'Cognitive status and sleep quality']","[{'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0184054', 'cui_str': 'Tray'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",,0.014124,"Dual task balance performance, functional mobility and gait speed improved more in the dual task training group after training (p <0.05).","[{'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Demirdel', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Turkey. Electronic address: fzt_sb@hotmail.com.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Erbahçeci', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.009']
2260,32653604,"Impact of bupivacaine injection to trocar sites on postoperative pain following laparoscopic hysterectomy: Results from a prospective, multicentre, double-blind randomized controlled trial.","OBJECTIVES


Laparoscopic surgery has numerous advantages over open surgery in view of postoperative pain. In this context, to elevate its benefits and patient satisfaction, different pain management interventions have been used so far. This study aimed to evaluate the effect of bupivacaine injection to trocar sites following laparoscopic hysterectomy for the management of postoperative pain.
STUDY DESIGN


In this study, patients were randomized into two groups (56 cases; 52 controls). A single injection of bupivacaine (0.5 %, 5 mg/mL) was introduced to trocar sites under subcutaneous tissue at a dose of 4 ml for the umbilicus and 2 ml for each 5-mm ancillary trocar site in the study group. No bupivacaine was administered to the control group. The primary aim was to measure differences in 2 -h postoperative numerical rating scale (NRS) pain scores between the two groups. The secondary aims were to evaluate differences between 1-, 4-, 6-, 24- and 48 -h postoperative NRS pain scores, surgical complications, estimated blood loss, duration of operation and analgesic consumption.
RESULTS


The number of postoperative rescue doses of analgesics was found to be lower in the study group compared to the control group (median of 2 vs. 4; p < 0.01). The 1-, 4-, 6-, 24- and 48-hour postoperative NRS pain scores were also found to be lower in the study group compared to the control group (p < 0.01 at each follow-up). The mean duration of surgery and uterus removal, as well as the estimated blood loss, were not significantly different between the two groups.
CONCLUSIONS


The present study suggests that bupivacaine injection to trocar sites is an effective and safe method for reducing pain following laparoscopic hysterectomy.",2020,The number of postoperative rescue doses of analgesics was found to be lower in the study group compared to the control group (median of 2 vs. 4; p < 0.01).,['laparoscopic hysterectomy'],"['laparoscopic hysterectomy', 'Laparoscopic surgery', 'bupivacaine injection to trocar sites', 'bupivacaine']","['48-hour postoperative NRS pain scores', '2 -h postoperative numerical rating scale (NRS) pain scores', 'mean duration of surgery and uterus removal', 'postoperative pain', 'postoperative NRS pain scores, surgical complications, estimated blood loss, duration of operation and analgesic consumption', 'estimated blood loss', 'pain', 'number of postoperative rescue doses of analgesics']","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4060211', 'cui_str': 'Bupivacaine Injection [Sensorcaine]'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.144145,The number of postoperative rescue doses of analgesics was found to be lower in the study group compared to the control group (median of 2 vs. 4; p < 0.01).,"[{'ForeName': 'Ismet', 'Initials': 'I', 'LastName': 'Hortu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ege University School of Medicine, Izmir, Turkey; Department of Stem Cell, Ege University Institute of Health Sciences, Izmir, Turkey. Electronic address: ismethortu@yahoo.com.'}, {'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Turkay', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Terzi', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kale', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Anaesthesiology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Balcı', 'Affiliation': 'Department of Anaesthesiology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Aydın', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Antonio Simone', 'Initials': 'AS', 'LastName': 'Laganà', 'Affiliation': 'Department of Obstetrics and Gynaecology, ""Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.07.007']
2261,32653606,Effects of the levonorgestrel intrauterine system on the endometrium after long-term exposure to mifepristone: Secondary outcomes of a randomized controlled trial.,"OBJECTIVE


Long-term treatment with progesterone receptor modulators (PRM) is associated with a distinct histological entity termed progesterone receptor modulator associated endometrial changes (PAEC). While accumulating evidence implies that these changes are benign and reversible after cessation of treatment, there are currently no data underpinning their development. Consequently, as a precaution, endometrial shedding is recommended after long-term PRM intake. Avoiding endometrial shedding after treatment with a PRM and prior to the start of a progestin treatment would be beneficial for women in reproductive age to avoid pregnancy and bleeding. However, the endometrial morphology with such a treatment regimen is unknown. The aim of this study was to delineate the endometrial morphology following continuous long-term treatment with the PRM mifepristone and subsequent placement of a levonorgestrel intrauterine system (LNG-IUS) without prior shedding of the endometrium.
STUDY DESIGN


This study reports the secondary outcome from a double-blinded randomized controlled trial conducted at Karolinska University Hospital, Sweden, November 2009 to January 2015. Healthy women aged 18-43 years with regular menstrual cycles were included. Eligible women were randomized to receive either 50 mg of mifepristone (n = 29) or a comparator (n = 29), every other day for two months followed by insertion of an LNG-IUS 52 mg. Endometrial biopsies were obtained at baseline and three months after placement of the device. The samples were histologically assessed. The main outcome measure of this sub-study was the endometrial morphology including presence of PAEC three months after LNG-IUS insertion.
RESULTS


Nine and eight paired biopsies from the mifepristone and comparator group, respectively, were included in the histological analysis. There were no differences in baseline characteristics between the groups and all baseline endometrial biopsies were physiological. Three months after LNG-IUS placement the endometrial morphology was still benign without PAEC in all samples treated with either mifepristone or comparator. A progestin effect on the endometrium was seen in all samples.
CONCLUSIONS


Placement of an LNG-IUS immediately following two months' treatment with the PRM mifepristone, without any prior shedding of the endometrium, may represent a feasible approach in terms of endometrial safety. However, larger studies are needed to confirm our results.",2020,Three months after LNG-IUS placement the endometrial morphology was still benign without PAEC in all samples treated with either mifepristone or comparator.,"['Karolinska University Hospital, Sweden, November 2009 to January 2015', 'Eligible women', 'Healthy women aged 18-43 years with regular menstrual cycles']","['progesterone receptor modulators (PRM', 'mifepristone', 'PRM mifepristone', 'levonorgestrel intrauterine system', 'progestin treatment', 'PRM mifepristone and subsequent placement of a levonorgestrel intrauterine system (LNG-IUS']",['Endometrial biopsies'],"[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C3653463', 'cui_str': 'Progesterone receptor modulators'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}]",,0.419988,Three months after LNG-IUS placement the endometrial morphology was still benign without PAEC in all samples treated with either mifepristone or comparator.,"[{'ForeName': 'Kiriaki', 'Initials': 'K', 'LastName': 'Papaikonomou', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. Electronic address: kiriaki.papaikonomou@ki.se.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Frisendahl', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Alistair R W', 'Initials': 'ARW', 'LastName': 'Williams', 'Affiliation': 'Division of Pathology, The Royal Infirmary of Edinburgh, The University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.056']
2262,32653721,Leveraging immersive technology to expand access to opioid overdose reversal training in community settings: Results from a randomized controlled equivalence trial.,"BACKGROUND


Immersive video (e.g. virtual reality) poses a promising and engaging alternative to standard in-person trainings and can potentially increase access to evidence-based opioid overdose prevention programs (OOPPs). Therefore, the objective of this equivalence study was to test whether the immersive video OOPP was equivalent to a standard in-person OOPP for changes in opioid overdose knowledge and attitudes.
METHODS


A team of nurses and communication researchers developed a 9-minute immersive video OOPP. To test whether this immersive video OOPP (treatment) demonstrated equivalent gains in opioid overdose response knowledge and attitudes as in-person OOPPs (standard of care control), researchers deployed a two-day field experiment in Philadelphia, Pennsylvania, USA. In this equivalence trial, 9 libraries were randomly assigned to offer treatment or control OOPP to community members attending naloxone giveaway events. In this equivalence design, a difference between treatment and control groups pre- to post-training scores within -1.0 to 1.0 supports equivalence between the trainings.
RESULTS


Results demonstrate participants (N = 94) exposed to the immersive video OOPP had equivalent improvements on posttest knowledge (β=-0.18, p = .61) and more favorable attitudes about responding to an opioid overdose (β=0.26, p = .02) than those exposed to the standard OOPP. However, these minor differences in knowledge and attitudes were within the equivalence interval indicating that the immersive video OOPP remained equivalently effective for community members.
CONCLUSIONS


Community partnerships, like those between public health departments and libraries, can provide opportunities for deploying novel immersive video OOPP that, alongside standard offerings, can strengthen community response to the opioid crisis.",2020,"RESULTS


Results demonstrate participants (N = 94) exposed to the immersive video OOPP had equivalent improvements on posttest knowledge (β=-0.18, p = .61) and more favorable attitudes about responding to an opioid overdose (β=0.26, p = .02) than those exposed to the standard OOPP.",['community settings'],"['immersive video OOPP (treatment', 'immersive video OOPP', 'control OOPP']","['posttest knowledge', 'favorable attitudes about responding to an opioid overdose']","[{'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",9.0,0.046718,"RESULTS


Results demonstrate participants (N = 94) exposed to the immersive video OOPP had equivalent improvements on posttest knowledge (β=-0.18, p = .61) and more favorable attitudes about responding to an opioid overdose (β=0.26, p = .02) than those exposed to the standard OOPP.","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Herbert', 'Affiliation': 'Woods Institute for the Environment, Stanford University, 473 Via Ortega, Stanford, CA, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Axson', 'Affiliation': 'School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, USA.'}, {'ForeName': 'Leeann', 'Initials': 'L', 'LastName': 'Siegel', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, 620 Walnut Street, Philadelphia, PA, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Cassidy', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, 620 Walnut Street, Philadelphia, PA, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Hoyt-Brennan', 'Affiliation': 'School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Whitney', 'Affiliation': 'School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Herens', 'Affiliation': 'Division of Substance Use Prevention and Harm Reduction, Philadelphia Department of Public Health, 1101 Market Street, 13th Floor, Suite 1320, Philadelphia PA, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Giordano', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Road, Atlanta, GA, USA. Electronic address: ngiorda@emory.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108160']
2263,32653726,High rate of antimicrobial resistance and multiple mutations in dihydrofolate reductase gene among Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania.,"OBJECTIVES


This study characterizes the molecular mechanisms of trimethoprim resistance and antibiotics resistance of Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania.
METHODS


A total of 1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a one-year follow-up from 2017 -2018 as part of the randomized clinical trial CoTrimResist (ClinicalTrials.gov identifier: NCT03087890).
RESULTS


A total of 76 pneumococcal isolates were obtained. Sixty percent (42/70) of isolates that could be serotyped were conjugate vaccine serotypes, pneumococcal conjugate vaccine 23 (PCV23). The majority (73.7%, 56/76) was penicillin non-susceptible minimum inhibitory concentration (MIC) 0.06 - 2 μg//ml. Isolates were frequently resistant to cotrimoxazole (71.1%) but less so to azithromycin (22.4%), erythromycin (21.1%), chloramphenicol (18.4%), tetracycline (14.5%), clindamycin (10.5%) and levofloxacin (none). Twenty-six percent were multi-drug resistant (resistant to ≥3 antibiotic classes). Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003. Cotrimoxazole-resistant isolates carried from 1 to 11 different mutations in dihydrofolate reductase gene, the most common being Ile100Leu (100%), Glu20Asp (92%), Glu94Asp (61%), Leu135Phe (57%), His26Tyr (53%), Asp92Ala (53%) and His120Gln (53%).
CONCLUSIONS


In conclusionStreptococcus pneumoniae isolated from HIV-diagnosed patients were frequently non-susceptible to penicillin and cotrimoxazole. Most isolates carried multiple mutations in the dihydrofolate reductase gene.",2020,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","['1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a one-year follow-up from 2017 -2018', 'Twenty-six percent were multi-drug resistant (resistant to ≥3 antibiotic classes', 'Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania', 'Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania']","['clindamycin', 'tetracycline', 'erythromycin, azithromycin, clindamycin and tetracycline', 'levofloxacin', 'chloramphenicol', 'erythromycin', 'azithromycin']",['penicillin non-susceptible minimum inhibitory concentration (MIC'],"[{'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0008168', 'cui_str': 'Chloramphenicol'}]","[{'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0427978', 'cui_str': 'MIC'}]",1877.0,0.4074,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Manyahi', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, MUHAS, Dar es Salaam, Tanzania. Electronic address: manyahijoel@yahoo.com.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, MUHAS, Dar es Salaam, Tanzania. Electronic address: sabrina.moyo@uib.no.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, MUHAS, Dar es Salaam, Tanzania. Electronic address: aboudsaid@yahoo.com.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Langeland', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway. Electronic address: nina.langeland@uib.no.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Blomberg', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway. Electronic address: bjorn.blomberg@uib.no.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2020.06.026']
2264,32653895,Optimizing behavior therapy for youth with Tourette's disorder.,"Tourette's Disorder (TD) is characterized by tics that cause distress and impairment. While treatment guidelines recommend behavior therapy as a first-line intervention, patients with TD may exhibit limited therapeutic response. Given the need to improve treatment outcomes, this study examined the efficacy of augmenting behavior therapy with D-cycloserine (DCS) to reduce tic severity in a placebo-controlled quick-win/fast-fail trial. Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity. Youth were randomly assigned to receive a single session of habit reversal training (HRT) augmented by either 50 mg of DCS or placebo. Two bothersome tics on the Hopkins Motor/Vocal Tic Scale (HM/VTS) were targeted for treatment during HRT. One week after the HRT session, youth completed a posttreatment assessment to evaluate change in the severity of bothersome tics. All assessments were completed by independent evaluators masked to treatment group. There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder. Follow-up comparisons revealed small group differences at the treatment visit (d = 0.27), with the DCS group exhibiting slightly greater severity for targeted tics. There was a large group difference at posttreatment, in which the DCS group exhibited lower severity for targeted tics (d = 1.30, p < 0.001) relative to the placebo group. Findings demonstrate the preliminary enhancement of tic severity reductions by augmenting HRT with DCS compared with placebo augmentation.",2020,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[""youth with Tourette's disorder"", 'Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity']","['placebo', 'habit reversal training (HRT) augmented by either 50\u2009mg of DCS or placebo', 'DCS', 'behavior therapy with D-cycloserine (DCS']","['Hopkins Motor/Vocal Tic Scale (HM/VTS', 'targeted tics', 'severity of bothersome tics']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0751901', 'cui_str': 'Tic, Vocal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.322576,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. jfmcguire@jhmi.edu.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Ginder', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kesley', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Joey Ka-Yee', 'Initials': 'JK', 'LastName': 'Essoe', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0762-4']
2265,32653912,Consequences of access to water from managed aquifer recharge systems for blood pressure and proteinuria in south-west coastal Bangladesh: a stepped-wedge cluster-randomized trial.,"BACKGROUND


Drinking-water salinity has been associated with high blood pressure (BP) among communities in south-west coastal Bangladesh. We evaluated whether access to water from managed aquifer recharge (MAR)-a hydrogeological intervention to lower groundwater salinity by infiltrating rainwater into the aquifers-can reduce community BP.
METHODS


We conducted a stepped-wedge cluster-randomized trial with five monthly visits between December 2016 and April 2017 in 16 communities. At each visit following baseline, four communities were randomized to access MAR water. Systolic BP was the primary outcome, measured during each visit using Omron® HEM-907 devices. We also measured participants' 24-hour urinary sodium and households' drinking- and cooking-water salinity each visit. We used multilevel regression models to estimate the effects of MAR-water access on participants' BP. The primary analysis was intention-to-treat.
RESULTS


In total, 2911 person-visits were conducted in communities randomized to have MAR-water access and 2834 in communities without MAR-water access. Households without MAR-water access predominantly used low-salinity pond water and 42% (range: 26-50% across visits) of households exclusively consumed MAR water when access was provided. Communities randomized to MAR-water access had 10.34 [95% confidence interval (CI): 1.11, 19.58] mmol/day higher mean urinary sodium, 1.96 (95% CI: 0.66, 3.26; p = 0.004) mmHg higher mean systolic BP and 1.44 (95% CI: 0.40, 2.48; p = 0.007) mmHg higher mean diastolic BP than communities without MAR-water access.
CONCLUSIONS


Our findings do not support the scale-up of MAR systems as a routine drinking-water source, since communities that shifted to MAR water from the lower-salinity pond-water source had higher urinary sodium and BP.",2020,"Communities randomized to MAR-water access had 10.34 [95% confidence interval (CI): 1.11, 19.58] mmol/day higher mean urinary sodium, 1.96 (95% CI: 0.66, 3.26; p = 0.004) mmHg higher mean systolic BP and 1.44 (95% CI: 0.40, 2.48; p = 0.007) mmHg higher mean diastolic BP than communities without MAR-water access.
","['stepped-wedge cluster-randomized trial with five monthly visits between December 2016 and April 2017 in 16 communities', 'blood pressure and proteinuria in south-west coastal Bangladesh', ""participants' BP"", 'communities in south-west coastal Bangladesh', 'In total, 2911 person-visits were conducted in communities randomized to have MAR-water access and 2834 in communities without MAR-water access']",['water from managed aquifer recharge (MAR)-a hydrogeological intervention'],"['Systolic BP', 'intention-to-treat', 'urinary sodium and BP', 'blood pressure (BP', 'mean diastolic BP', 'mean systolic BP']","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C3178977', 'cui_str': 'Aquifers'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C3178977', 'cui_str': 'Aquifers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.172861,"Communities randomized to MAR-water access had 10.34 [95% confidence interval (CI): 1.11, 19.58] mmol/day higher mean urinary sodium, 1.96 (95% CI: 0.66, 3.26; p = 0.004) mmHg higher mean systolic BP and 1.44 (95% CI: 0.40, 2.48; p = 0.007) mmHg higher mean diastolic BP than communities without MAR-water access.
","[{'ForeName': 'Abu Mohd', 'Initials': 'AM', 'LastName': 'Naser', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Solaiman', 'Initials': 'S', 'LastName': 'Doza', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'Kazi M', 'Initials': 'KM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Geology, University of Dhaka, Dhaka, Bangladesh.'}, {'ForeName': 'Shuchi', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'Division of Nephrology, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shahjada', 'Initials': 'S', 'LastName': 'Selim', 'Affiliation': 'Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University, Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shamsudduha', 'Affiliation': 'Institute for Risk and Disaster Reduction, University College London, London, UK.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Hubert Department of Global Health, Emory Global Diabetes Research Center, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Matthew O', 'Initials': 'MO', 'LastName': 'Gribble', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Division of Infectious Diseases and Geographic Medicine, Stanford University, Stanford, CA, USA.'}]",International journal of epidemiology,['10.1093/ije/dyaa098']
2266,32654022,Two different therapies for the middle turbinate during endoscopic sinus surgery for chronic rhinosinusitis.,"BACKGROUND


The population of patients with chronic rhinosinusitis (CRS) has greatly increased. When medical treatment fails, endoscopic sinus surgery (ESS) is considered. In the present study, the value of two different therapies for the middle turbinate to optimize surgical outcomes was observed. Our objective was to determine a better management approach for the middle turbinate to effectively preserve the middle turbinate mucosa and function and avoid complications following ESS, such as nasal adhesions on the operative side.
METHODS


Thirty patients [group A; treated prior to 2015 (primary surgery)] undergoing resection of the middle turbinate bone during complete ESS for CRS and 30 patients [group B; treated after 2015 (later surgery)] undergoing middle turbinate preservation and multiapproach therapy during complete ESS for CRS were observed. Nasal cavities were compared using perioperative sinus endoscopy (POSE) and Lund-Kennedy (LKES) scores preoperatively and at 15 days, 2 months and 1 year after ESS.
RESULTS


Preoperatively, the POSE (8.83 ± 3.81 vs 9.15 ± 3.85, p = 0.45, for groups A and B, respectively) and LKES (4.23 ± 0.74 vs 4.13 ± 0.70, p = 0.34) scores were similar between groups. In group A, anterior adhesions were reported on six sides of the middle turbinate, severe adhesions were observed on two sides, mild adhesions were observed on one side, and adhesions occurred on two sides during follow-up. After retreatment, adhesions were still observed on two sides at 1 year. In group B, only mild anterior adhesions were observed on two sides. There was no difference between group A and group B at 15 days, and the POSE (4.31 ± 1.19 vs 4.07 ± 1.42, p = 0.11, for groups A and B, respectively) and LKES (3.35 ± 0.82 vs 3.33 ± 0.90, p = 0.91) scores were similar between groups. There was no significant difference in LKES (0.22 ± 0.49 vs 0.10 ± 0.35, p = 0.15) scores at 1 year between the two groups. There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
CONCLUSIONS


Our results show that middle turbinate preservation and combined therapy was a better ESS method for CRS. Multiapproach middle conchoplasty, which is predominately a submucoperiosteal surgery, can preserve more of the mucosa and functions of the middle turbinate. Unlike the single-approach middle conchoplasty described in previous research, multiapproach middle conchoplasty is achieved by combining a three-step surgical procedure (""surgery, packing and removal"") with ""cocktail-style"" postoperative packing and removal.",2020,"There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
","['patients with chronic rhinosinusitis (CRS', 'chronic rhinosinusitis', 'Thirty patients [group A']","['endoscopic sinus surgery', 'treated prior to 2015 (primary surgery)] undergoing resection of the middle turbinate bone during complete ESS for CRS and 30 patients [group B; treated after 2015 (later surgery)] undergoing middle turbinate preservation and multiapproach therapy', 'endoscopic sinus surgery (ESS']","['nasal cavities', 'endoscopic appearance', 'LKES', 'LKES scores', 'severe adhesions', 'mild anterior adhesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",,0.0319759,"There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
","[{'ForeName': 'Meichan', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China. zhumeichan@126.com.""}, {'ForeName': 'Yongyi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China. yungyi@188.com.""}, {'ForeName': 'Huicheng', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}, {'ForeName': 'Yunwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}, {'ForeName': 'Guojie', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06184-4']
2267,32654080,"Comparison of efficacy and safety of urate-lowering therapies for hyperuricemic patients with gout: a meta-analysis of randomized, controlled trials.","OBJECTIVES


To assess the efficacy and safety of the commonly used urate-lowering therapies (ULTs): febuxostat, allopurinol, and lesinurad in hyperuricemic patients with gout.
METHODS


We included all randomized controlled trials (RCTs) that compared ULTs with placebo or head to head. The primary efficacy endpoint was the proportion of subjects achieving the target serum urate (SU) level at month 6. Safety outcomes included total adverse events (AEs), serious AEs, withdrawals due to AEs, and AEs per organ system. A Bayesian network model was used to compare all ULTs with placebo and among themselves.
RESULTS


Fifteen RCTs were included for the analysis, in which 7968 patients were randomly assigned to take either placebo or one of 11 ULTs: allopurinol, febuxostat 40/80/120/240 mg/day, lesinurad 400 mg/day, lesinurad 200/400/600 mg/day plus allopurinol, and lesinurad 200/400 mg/day plus febuxostat. All ULTs were effective in achieving the target SU level at month 6 compared with placebo (ORs between 26.81 and 1928). Febuxostat 80/120/240 mg/day was superior to allopurinol and well tolerated for urate reduction. And as febuxostat dosage increased, more patients achieved the target SU level. Furthermore, the lesinurad combination with xanthine oxidase inhibitor (XOI) groups had a higher proportion of patients achieving the target SU level than the febuxostat 40 mg/day group (ORs between 2.89 and 9.17), the allopurinol group (ORs between 3.56 and 11.27), or the lesinurad 400 mg/day monotherapy group (ORs between 12.30 and 39.17) but might have a high risk of AEs.
CONCLUSIONS


All ULTs are effective in achieving the target SU level compared with placebo in hyperuricemic patients with gout. Lesinurad in combination with febuxostat or allopurinol is effective in urate lowering, especially for patients with inadequate response to XOI monotherapy. Key Points • All urate-lowering therapies (ULTs) were effective in achieving the target serum urate (SU) level at month 6 compared with placebo in hyperuricemic patients with gout. • Febuxostat 80/120/240 mg/day was superior to allopurinol and well tolerated for urate reduction. And as febuxostat dosage increased, more patients achieved the target SU level. • Lesinurad in combination with febuxostat or allopurinol was effective in urate lowering, especially for patients with inadequate response to xanthine oxidase inhibitor monotherapy, but might have a high risk of AEs.",2020,All urate-lowering therapies (ULTs) were effective in achieving the target serum urate (SU) level at month 6 compared with placebo in hyperuricemic patients with gout.,"['hyperuricemic patients with gout', 'Fifteen RCTs were included for the analysis, in which 7968 patients', 'patients with inadequate response to XOI monotherapy']","['urate-lowering therapies', 'xanthine oxidase inhibitor (XOI', 'All urate-lowering therapies (ULTs', 'ULTs with placebo', 'Febuxostat', 'febuxostat or allopurinol', 'urate-lowering therapies (ULTs): febuxostat, allopurinol', 'allopurinol', 'allopurinol, febuxostat 40/80/120/240', 'allopurinol, and lesinurad 200/400\xa0mg/day plus febuxostat', 'placebo']","['total adverse events (AEs), serious AEs, withdrawals due to AEs, and AEs per organ system', 'target serum urate (SU) level', 'proportion of subjects achieving the target serum urate (SU) level', 'efficacy and safety', 'target SU level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}]","[{'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C3886073', 'cui_str': 'lesinurad'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0460002', 'cui_str': 'Body system structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}]",7968.0,0.223971,All urate-lowering therapies (ULTs) were effective in achieving the target serum urate (SU) level at month 6 compared with placebo in hyperuricemic patients with gout.,"[{'ForeName': 'Meida', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': ""Department of Rheumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, People's Republic of China.""}, {'ForeName': 'Bingcheng', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, People's Republic of China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe, Guangzhou, 510630, People's Republic of China.""}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""The Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital; State Key Laboratory of Respiratory Disease, Sino-French Hoffmann Institute, School of Basic Medical Sciences, Guangzhou Medical University, Xinzao, Panyu, Guangzhou, 511436, Guangdong, People's Republic of China. xuefengli@gzhmu.edu.cn.""}, {'ForeName': 'Jieruo', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': ""Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe, Guangzhou, 510630, People's Republic of China. gujieruo@163.com.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Schlesinger', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, 08901, USA. schlesna@aol.com.'}]",Clinical rheumatology,['10.1007/s10067-020-05272-4']
2268,32654111,"Efficacy Of Preoperative Gabapentin on Pain Severity after Posterior Urethral Surgery:A Randomized, Double-Blind, Placebo-Controlled Study.","PURPOSE


Prevention and treatment of urethroplastic postoperative pain is a major challenge in post-surgery care. gabapentin can treat postoperative pain by preventing excessive sensitivity to the central nervous system. we have tried to compare the effect of gabapentin with the placebo on reducing the pain associated with posterior urethroplasty in patients.
MATERIAL AND METHOD


This prospective, randomized, double-blind study was scheduled in Shohad e Tajrish hospital where a single dose of Gabapentin was compared with placebo given to patients preoperatively. In this study,100 patients with posterior urethral stricture were included for surgery with 50 patients in each arms .All patients underwent posterior urethroplasty. After surgery, the pain level is assessed and evaluated by the visual analog scale in two hours,four hours, six hours,eight hours, twelve hours, and 24 hours after the operation.
RESULT


In this study, there was a significant difference in the pain level that was evaluated by the visual analog scale in two hours, four hours, six hours, eight hours, twelve hours, and 24 hours after the surgery (p.value <0.001). We also found a significant decrease in morphine consumption in the gabapentin group vs the placebo group. (p.value <0.001) The post-surgery assessments showed significant lower adverse effects such as vomiting, nausea, drowsiness, and pruritus in the gabapentin group vs. placebo group.
CONCLUSION


The consequences of this study revealed that gabapentin effective in controlling posterior urethroplasty postoperative pain, consumption of opioid, nausea, vomiting, drowsiness, and pruritus compared with the placebo group.",2020,"The post-surgery assessments showed significant lower adverse effects such as vomiting, nausea, drowsiness, and pruritus in the gabapentin group vs. placebo group.
","['after Posterior Urethral Surgery', 'patients', 'study,100 patients with posterior urethral stricture were included for surgery with 50 patients in each arms .All']","['Placebo', 'gabapentin', 'posterior urethroplasty', 'Preoperative Gabapentin', 'Gabapentin', 'placebo']","['adverse effects such as vomiting, nausea, drowsiness, and pruritus', 'pain level', 'posterior urethroplasty postoperative pain, consumption of opioid, nausea, vomiting, drowsiness, and pruritus', 'morphine consumption', 'Pain Severity', 'visual analog scale']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720815', 'cui_str': 'Urethral Stricture, Posterior'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.345212,"The post-surgery assessments showed significant lower adverse effects such as vomiting, nausea, drowsiness, and pruritus in the gabapentin group vs. placebo group.
","[{'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Ghiasy', 'Affiliation': ""1. Men's health and Reproductive Health Research Center , Shahid Beheshti university of Medical Sciences,Tehran, Iran. saleh.ghiasy@sbmu.ac.ir.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tayebi-Azar', 'Affiliation': 'Nephrology and Kidney transplant Research Center, Urmia University of Medical Sciences, Urmia , Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Alinezhad', 'Affiliation': 'Department of Clinical pharmacy, School of Pharmacy, Tehran university of medical sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Fallah-Karkan', 'Affiliation': ""Men's health and Reproductive Health Research Center , Shahid Beheshti university of Medical Sciences,Tehran, Iran.""}, {'ForeName': 'Hojat', 'Initials': 'H', 'LastName': 'Salimi', 'Affiliation': ""Men's health and Reproductive Health Research Center , Shahid Beheshti university of Medical Sciences,Tehran, Iran.""}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Hojjati', 'Affiliation': ""Men's health and Reproductive Health Research Center , Shahid Beheshti university of Medical Sciences,Tehran, Iran.""}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Hosseini', 'Affiliation': 'Professor of Urology, Reconstructive Urology Department, Shohada-e -Tajrish hospital, Shahid Beheshti Medical Science University, Iran.'}]",Urology journal,['10.22037/uj.v0i0.5598']
2269,32654156,Neuropathy Symptom and Change: Inotersen Treatment of Hereditary Transthyretin Amyloidosis.,"INTRODUCTION


Hereditary transthyretin-mediated amyloidosis (hATTR) manifests as multisystem dysfunction, including progressive polyneuropathy. Inotersen, an antisense oligonucleotide, improved the course of neuropathic impairment in patients with hATTR in the pivotal NEURO-TTR study (NCT01737398). To determine inotersen's impact on symptoms and patients' neuropathy experience, we performed a post hoc analysis of the Neuropathy Symptoms and Change (NSC) score.
METHODS


Stage 1/2 hATTR patients were randomized to receive weekly subcutaneous inotersen or placebo for 65 weeks. NSC score was assessed at baseline, 35, and 66 weeks.
RESULTS


At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
DISCUSSION


Inotersen treatment stabilized neuropathy symptoms, including autonomic symptoms, in patients with hATTR based on the NSC score, which may be an effective assessment of neuropathy progression and patients' neuropathy experience in clinical practice. This article is protected by copyright. All rights reserved.",2020,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","['patients with hATTR based on the NSC score', 'Stage 1/2 hATTR patients', 'Hereditary Transthyretin Amyloidosis']","['subcutaneous inotersen or placebo', 'placebo']","['NSC score', 'Neuropathy Symptoms and Change (NSC) score', 'muscle weakness, sensory, pain, and autonomic symptoms', 'neuropathic impairment', 'Neuropathy Symptom and Change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0554384,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Neurosciences, Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'Marcia Waddington', 'Initials': 'MW', 'LastName': 'Cruz', 'Affiliation': 'Neurology, Federal University of Rio de Janeiro, University Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Peripheral Neuropathy, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Khella', 'Affiliation': 'Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Medicine, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc, San Diego, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals Inc., Carlsbad, California, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals Inc., Carlsbad, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Boston, Massachusetts, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27023']
2270,32654212,Mnis+7 And Lower Limb Function In Inotersen Treatment Of Hattr.,"INTRODUCTION


Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy. This analysis assessed the mNIS+7 components by anatomic location and the Lower Limb Function (LLF) test.
METHODS


Adults with hATTR were randomly assigned to receive weekly doses of subcutaneous inotersen 300 mg or placebo for 65 weeks. The mNIS+7 and LLF were assessed at 35 and 66 weeks.
RESULTS


All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation) and the LLF showed significant efficacy in patients receiving inotersen versus placebo; however, NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate deep breathing did not show significant effects.
DISCUSSION


The results of this analysis reinforce the beneficial effect of inotersen on slowing neuropathy progression in patients with hATTR polyneuropathy. This article is protected by copyright. All rights reserved.",2020,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","['Adults with hATTR', 'patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy', 'patients with hATTR polyneuropathy']","['subcutaneous inotersen 300 mg or placebo', 'placebo']","['All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation', 'mNIS+7 and LLF', 'Mnis+7 And Lower Limb Function', 'NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate deep breathing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0206247', 'cui_str': 'Polyneuropathy in amyloidosis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1504824', 'cui_str': 'SLC5A5 protein, human'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}]",,0.124471,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc, San Diego, CA, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Cambridge, MA, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals Inc., Carlsbad, CA, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals Inc., Carlsbad, CA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, MN, USA.'}]",Muscle & nerve,['10.1002/mus.27022']
2271,32654242,Does Lepidium meyenii (Maca) improve seminal quality?,"Maca (Lepidium meyenii) is a herbaceous plant grown at over 4,000 m in Peru. It has been studied worldwide for its properties on fertility. Previous studies have assessed maca effects on semen quality, but there is need of randomised, double-blind trials in order to make clinical decisions. The objective of this study was to assess the effect of maca on seminal parameters in infertile adult men. This is a double-blind, randomised, placebo-controlled pilot trial in which sixty-nine patients diagnosed with mild asthenozoospermia and/or mild oligozoospermia were supplied by maca (n = 35) or placebo (n = 34) (2 g/day) for a period of 12 weeks. When compared patients treated with maca and patients treated with placebo, there were no significant differences in semen volume (2.95 ± 0.52 vs. 2.90 ± 0.52; p = .392), sperm motility (22.34 ± 2.22 vs. 23.05 ± 2.22; p = .462) and normal sperm morphology (7.89 ± 1.89 vs. 7.04 ± 2.28; p = .801), but there was a significant difference in sperm concentration (15.04 ± 5.61 vs. 10.16 ± 3.59, respectively; p = .011). In conclusion, patients treated with 2 g of maca for a period of 12 weeks showed a significant improvement in seminal concentration compared with patients treated with placebo. There were no significant differences in semen volume, sperm mobility and morphology when compared both groups.",2020,"There were no significant differences in semen volume, sperm mobility and morphology when compared both groups.","['sixty-nine patients diagnosed with mild asthenozoospermia and/or mild oligozoospermia were supplied by maca (n\xa0=\xa035) or', 'n\xa0=\xa034', 'infertile adult men']",['placebo'],"['sperm motility', 'normal sperm morphology', 'seminal concentration', 'sperm concentration', 'semen volume, sperm mobility and morphology', 'semen volume']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0028960', 'cui_str': 'Oligospermia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0872905', 'cui_str': 'Maca'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0577266', 'cui_str': 'Sperm normal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0427992', 'cui_str': 'Semen volume measurement'}]",69.0,0.517476,"There were no significant differences in semen volume, sperm mobility and morphology when compared both groups.","[{'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Alcalde', 'Affiliation': 'Gynaecology and Obstetrics Department, Faculty of Medicine, Hospital Vall d`Hebron, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rabasa', 'Affiliation': 'Gynaecology and Obstetrics Department, Faculty of Medicine, Hospital Vall d`Hebron, Autonomous University of Barcelona, Barcelona, Spain.'}]",Andrologia,['10.1111/and.13755']
2272,32654255,Does physical exercise and congruent visual stimulation enhance perceptual learning?,"PURPOSE


There is currently great interest in methods that can modulate brain plasticity, both in terms of understanding the basic mechanisms, and in the remedial application to situations of sensory loss. Recent work has focussed on how different manipulations might be combined to produce new settings that reveal synergistic actions. Here we ask whether a prominent example of adult visual plasticity, called perceptual learning, is modified by other environmental factors, such as visual stimulation and physical exercise.
METHODS


We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness). We trained subjects for 5 days on a Vernier alignment task. In one group, we introduced an exercise protocol with congruent visual stimulation. The control group received the same visual stimulation, but did not exercise prior to measurement of Vernier thresholds.
RESULTS


Although the task generated large amounts of learning (~40%) and some transfer to untrained conditions in both groups, there were no specific benefits associated with either the addition of an exercise schedule or congruent visual stimulation.
CONCLUSION


In adults, short periods of physical exercise and visual stimulation do not enhance perceptual learning.",2020,"We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness).","['two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness']","['exercise protocol with congruent visual stimulation', 'physical exercise and visual stimulation', 'same visual stimulation, but did not exercise prior to measurement of Vernier thresholds', 'physical exercise and congruent visual stimulation']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",[],,0.0464675,"We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness).","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campana', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fongoni', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Astle', 'Affiliation': 'Visual Neuroscience Group, School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'McGraw', 'Affiliation': 'Visual Neuroscience Group, School of Psychology, University of Nottingham, Nottingham, UK.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12712']
2273,32654257,Improving Follow-Up Attendance for Discharged Emergency Care Patients Using Automated Phone System to Self-Schedule: A Randomized Controlled Trial.,"BACKGROUND


Automated phone appointment reminders have improved adherence with follow-up appointments in a variety of hospital settings, but have mixed results in patients discharged from the emergency department (ED). Increasing adherence to follow-up care has been a priority in the ED to improve patient outcomes and reduce unnecessary future visits.
METHODS


We conducted a prospective randomized open, blinded end-point (PROBE) trial of 278 adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard of care written instructions to contact listed referral providers. The primary outcome was time to appointment. The secondary outcome was time to return visit to the ED.
RESULTS


The automated reminders increased the cumulative incidence of keeping the referral appointment after ED discharge (p-value < 0.001, Gray's test). Of participants randomized to the automated phone intervention, 49.3% (n=74) kept their follow-up appointment vs. 23.4% (n=30) in the control arm, with a hazard ratio (HR) and 95% confidence interval (CI) over the duration of the study period of 2.4 (1.6-3.7), p < 0.001. In a sensitivity analysis using 30 days of follow-up data, 42.0% (n=63) of participants randomized to the phone intervention kept their follow-up vs. 21.1% (n=27) in the control arm, with a HR and (95% CI) of 2.2 (1.4-3.5), p < 0.001. There was no difference in ED revisits between the intervention and control group within 120-days post-discharge.
CONCLUSIONS


An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.",2020,"An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.","['278 adult patients discharged from the ED and referred to a provider for follow-up care', 'patients discharged from the emergency department (ED', 'Discharged Emergency Care Patients']",['self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders'],"['cumulative incidence of keeping the referral appointment after ED discharge', 'time to return visit to the ED', 'ED revisits', 'time to appointment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",278.0,0.137672,"An automated self-scheduling phone system significantly improved follow-up adherence after ED discharge, but did not decrease ED revisits.","[{'ForeName': 'Kyla L', 'Initials': 'KL', 'LastName': 'Bauer', 'Affiliation': 'School of Medicine, Washington University, Saint Louis, Missouri, United States.'}, {'ForeName': 'Omolade O', 'Initials': 'OO', 'LastName': 'Sogade', 'Affiliation': 'School of Medicine, Washington University, Saint Louis, Missouri, United States.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'Gage', 'Affiliation': 'General Medical Sciences, Washington University, Saint Louis, Missouri, United States.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Ruoff', 'Affiliation': 'School of Medicine, Department of Emergency Medicine, Washington University, Saint Louis, Missouri, United States.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lewis', 'Affiliation': 'School of Medicine, Department of Emergency Medicine, Washington University, Saint Louis, Missouri, United States.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14080']
2274,32654362,Randomised phase II study comparing alternating cycles of sunitinib and everolimus versus standard sequential administration in first-line metastatic renal carcinoma (SUNRISES study).,"BACKGROUND


Alternating blockade of vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin (mTOR) pathways could potentially prevent the occurrence of resistance to anti-VEGFR therapy in metastatic renal cell carcinoma (mRCC).
METHODS


SUNRISES, a randomised open-label phase II study, investigated the efficacy of alternating cycles of sunitinib and everolimus compared to standard sequential treatment of sunitinib followed by everolimus upon progression. Treatment-naïve patients with clear-cell mRCC were included. Alternating treatment consisted on 12 weeks of sunitinib, followed by 12 weeks of everolimus. Primary endpoint was progression-free survival (PFS) rate at 1 year. Secondary endpoints included median PFS, overall survival (OS), response rate and safety.
RESULTS


Accrual was low due to the advent of new-generation therapies, and the study was stopped prematurely. Only 41 patients out of the planned 102 patients were accrued, and randomised in a 2:1 ratio (15 patients to the control arm, 26 to the experimental arm). 60.9% of patients had performance status (PS) 0 and 39% PS 1. 63% of patients had a favourable prognostic risk profile while 36% were intermediate risk. Primary endpoint was not met. 1-year PFS rate was 49.7% (experimental arm) versus 84.62% (control arm), p=0.11. There was a trend towards fewer grade 3 or higher adverse events with the alternating approach (50% versus 73.3%; p=0.14). Median OS was similar in both treatment arms. The other secondary endpoints favoured the control arm.
CONCLUSIONS


The study failed to show any benefit of alternating cycles of sunitinib and everolimus in patients with mRCC. The alternating approach using an mTOR inhibitor does not seem to prevent the occurrence of resistance to VEGFR blockade.",2020,"PFS rate was 49.7% (experimental arm) versus 84.62% (control arm), p=0.11.","['41 patients out of the planned 102 patients', 'patients with mRCC', 'Treatment-naïve patients with clear-cell mRCC', 'first-line metastatic renal carcinoma (SUNRISES study', 'metastatic renal cell carcinoma (mRCC']","['everolimus', 'rapamycin (mTOR', 'sunitinib and everolimus']","['favourable prognostic risk profile', 'Median OS', 'median PFS, overall survival (OS), response rate and safety', 'progression-free survival (PFS) rate', 'adverse events', 'PFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0919989', 'cui_str': 'Metastatic renal carcinoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",102.0,0.0702853,"PFS rate was 49.7% (experimental arm) versus 84.62% (control arm), p=0.11.","[{'ForeName': 'Alejo', 'Initials': 'A', 'LastName': 'Rodriguez-Vida', 'Affiliation': ""Hospital del Mar-Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National & Kapodistrian University of Athens, Dept of Clinical Therapeutics, Alexandra General Hospital, Athens, Greece.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Esteban', 'Affiliation': 'Hospital Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Saez', 'Affiliation': 'Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lopez-Brea', 'Affiliation': 'Hospital Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital, 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Caballero', 'Affiliation': 'Hospital General Universitario de Valencia, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Luis Gonzalez-Larriba', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': 'START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Macia', 'Affiliation': 'Pivotal, Madrid, Spain.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Hôpital Saint André, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': ""Hospital del Mar-Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}]",BJU international,['10.1111/bju.15165']
2275,32654395,A pilot randomized controlled trial comparing online versus face-to-face delivery of an aphasia communication partner training program for student healthcare professionals.,"BACKGROUND


Training conversation partners of people with aphasia who use facilitative communication strategies is one method that can improve access to healthcare for people with aphasia. However, the efficacy of communication partner training (CPT) has been investigated almost exclusively in the context of face-to-face (F2F) delivery. Online training may offer more cost-effective and accessible options to a wider range of conversation partners, including student healthcare professionals.
AIMS


To conduct a pilot randomized controlled trial with student healthcare professionals comparing (1) an online aphasia CPT program, (2) a F2F CPT program and (3) no program (control group) on outcomes relating to attitudes and knowledge of aphasia.
METHODS & PROCEDURES


A 45-min introductory aphasia CPT program was developed using the theories and techniques of Supported Conversations for Adults with Aphasia (SCA)™. A total of 30 first-year undergraduates studying occupational therapy at The University of Sydney were randomly allocated to one of three conditions: online CPT delivery, F2F delivery or delayed training control (no program). Outcomes measures included pre-post-testing with the Aphasia Attitudes, Strategies and Knowledge (AASK) survey.
OUTCOMES & RESULTS


A significant difference existed for the AASK survey pre-post-change scores between the online, F2F and control groups (χ 2  (2) = 20.038, p = 0.000). Post-hoc analysis revealed that, compared with the control (Ctrl) group, participants in both the online and F2F groups had significantly higher knowledge of aphasia (Online versus Ctrl: p = 0.000; F2F versus control: p = 0.002), knowledge of facilitative strategies (Online versus Ctrl: p = 0.000; F2F versus Ctrl: p = 0.002), and positive attitudes towards aphasia (Online versus Ctrl: p = 0.031; F2F versus Ctrl: p = 0.032). No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000).
CONCLUSIONS AND IMPLICATIONS


The results from this pilot randomized controlled trial indicate that online delivery of the 45-min introductory CPT is equally as efficacious as F2F delivery, and thus may be a viable mode of delivery for future aphasia CPT programs. These pilot results pave the way for a larger study that will comprehensively evaluate the efficacy of an online aphasia CPT program for improving attitudes, knowledge and skills in a broad range of student healthcare professionals. What this paper adds What is already known on this subject The efficacy of F2F CPT for aphasia is well established. Online delivery of CPT programs may offer more cost-effective and accessible services when compared with F2F approaches; however, there is a need to explore the efficacy of online programs. What this paper adds to existing knowledge The 45-min online aphasia CPT program was found to be efficacious for improving student healthcare professionals' knowledge and attitudes towards aphasia and communication, and produced equally successful outcomes when compared with F2F delivery. This is the first study to report the efficacy of an online CPT program that is aligned with SCA for use with student healthcare professionals that also uses a self-report outcome measure with validated psychometric properties. What are the potential or actual clinical implications of this work? Online CPT programs may be useful in both clinical and education contexts to support improved efficiency of services and to enhance communication environments for people with aphasia in healthcare contexts.",2020,"No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000).
","['student healthcare professionals', 'Adults with Aphasia (SCA)™', 'A total of 30 first-year undergraduates studying occupational therapy at The University of Sydney', 'people with aphasia in healthcare contexts']","['online aphasia CPT program', 'online CPT delivery, F2F delivery or delayed training control (no program', 'student healthcare professionals comparing (1) an online aphasia CPT program, (2) a F2F CPT program and (3) no program (control group', 'Online training', 'aphasia communication partner training program', 'online CPT program', 'communication partner training (CPT']","['knowledge of aphasia', 'knowledge of facilitative strategies', 'positive attitudes towards aphasia', 'pre-post-testing with the Aphasia Attitudes, Strategies and Knowledge (AASK) survey']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0449255', 'cui_str': 'Context'}]","[{'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",30.0,0.0452615,"No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000).
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': 'University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnes', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Elbourn', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}]",International journal of language & communication disorders,['10.1111/1460-6984.12556']
2276,32654400,Safety and Efficacy of Single Pass Versus MultiPass emission with 755 alexandrite Laser for All-Skin-Type Hair Removal: a pilot study.,"INTRODUCTION


Lasers are considered the most efficient methods for hair reduction. The goal of these devices is to provide long-term effects without adverse reactions.
OBJECTIVES


This is a randomised split-body controlled study on body hair removal and pseudofolliculitis (PFC) treatment, comparing the standard Single Pass (SP) emission with the MultiPass emission (Moveo handpiece) with 755 alexandrite laser.
MATERIAL AND METHODS


Patients with Fitzpatrick skin types I-VI underwent laser hair removal, by treating one side of the body using the standard SP and the other side with Moveo. Treated areas included face, arms, legs, trunk, axillae and groins. Each patient underwent a minimum of three to a maximum of eight treatments, every 6 weeks, with a 6-month follow-up. Hair reduction, side effects, PFC severity score and patient satisfaction were recorded for all patients.
RESULTS


Totally, 108 patients were enrolled, of whom 96 were female. The overall hair reduction rate (% ± SD), independent of skin type, was estimated as 87 ± 5.5 for standard SP and 78.5 ± 7.6 for Moveo. No significant statistically differences were found between the two groups. Side effects included pain, which was higher after standard SP (4.2 ± 0.8) than after Moveo treatment (1.5 ± 0.5). A statistical significant difference between the two devices was found (p=0.0002). PFC score improved in almost all the patients. Patients declared to be satisfied with both the treatments, reporting a preference for Moveo (84% vs 16%) (p=0.01).
CONCLUSION


Standard SP and Moveo 755 alexandrite laser seems to be safe and effective treatments for hair removal in all Fitzpatrick skin types and for PFC. Moveo has a higher security profile with fewer side effects. This article is protected by copyright. All rights reserved.",2020,"Side effects included pain, which was higher after standard SP (4.2 ± 0.8) than after Moveo treatment (1.5 ± 0.5).","['108 patients were enrolled, of whom 96 were female', 'Patients with Fitzpatrick skin types I-VI underwent laser hair removal, by treating one side of the body using the standard SP and the other side with Moveo']","['Single Pass Versus MultiPass emission with 755 alexandrite Laser', 'standard Single Pass (SP) emission with the MultiPass emission (Moveo handpiece) with 755 alexandrite laser', 'body hair removal and pseudofolliculitis (PFC']","['Hair reduction, side effects, PFC severity score and patient satisfaction', 'overall hair reduction rate', 'PFC score', 'Safety and Efficacy']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0587210', 'cui_str': 'Laser removal of hair'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445262', 'cui_str': 'Single pass'}]","[{'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0392245', 'cui_str': 'Alexandrite laser device'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181115', 'cui_str': 'Handpiece'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0018504', 'cui_str': 'Epilation'}, {'cui': 'C0406191', 'cui_str': 'Pseudofolliculitis'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0406191', 'cui_str': 'Pseudofolliculitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",108.0,0.0449255,"Side effects included pain, which was higher after standard SP (4.2 ± 0.8) than after Moveo treatment (1.5 ± 0.5).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bonan', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Troiano', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Verdelli', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}]",Dermatologic therapy,['10.1111/dth.14001']
2277,32654447,[Analysis of the safety and efficacy of bronchial thermoplasty for severe asthma with the first second forced expiratory volume (FEV(1)) as a percentage of the predicted value (FEV(1)%pred)<60].,"Objective:  To investigate the efficacy and safety of bronchial thermoplasty (BT) in severe asthma patients with the first second forced expiratory volume (FEV(1)) as a percentage of the predicted value (FEV(1)%pred) <60%.  Methods:  A retrospective analysis was performed on 75 patients with asthma who were treated with BT at Shenzhen University Hospital of the Chinese Academy of Sciences from January 2016 to January 2018. The patients were divided into two groups based on the FEV(1)%pred before treatment: FEV(1)%pred <60% group (39 cases) and FEV(1)%pred ≥60% group (36 cases). Comparative analysis of glucocorticoid consumption, times of acute attack, asthma control test (ACT) score, changes in lung function, and adverse reactions at 3 weeks after treatment were performed between the two groups of patients.  Results:  Before BT treatment, the consumption of oral prednisone, the amount of budesonide inhaled, and the times of acute attack [ M  ( Q (1),  Q (3))] in the FEV(1)%pred <60% group were significantly greater than those in the FEV(1)%pred ≥60% group, and the ACT score was significantly lower than the FEV(1)%pred ≥60% group [10.00 (0, 20.00) vs 0(0, 3.75) mg/d, 960 (320, 960) vs 320 (320, 640) μg/d, 5(4, 8) vs 4 (4, 5) times/year, 13 (9, 15) vs 17 (13, 19) scores] (all  P< 0.05). Except that the oral prednisone dosage in the FEV(1)%pred<60% group was still higher 1 year after treatment [0 (0, 5.00) vs 0 (0, 0) mg/d] ( P= 0.009), there was no significant difference in the remaining indicators between the two groups 1 year after treatment and 2 years after treatment (all  P> 0.05). After 1 year and 2 years of treatment, all indicators in the two groups were better than before treatment (all  P< 0.05). The inhaled budesonide amount and the times of acute exacerbation in the FEV(1)%pred <60% group 2 years after treatment were less than those 1 year after treatment [320 (320, 320) vs 320 (320, 640) μg/d, 0 (0, 0) vs 0(0, 1) times/year] (all  P< 0.05), and there was no significant difference in the remaining indicators. In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05). In the FEV(1)%pred <60% group, FEV(1) and the FEV(1)%pred were significantly lower than the FEV(1)%pred ≥60% group before treatment, 1 year after treatment and 2 years after treatment [FEV(1):(1.21±0.41) vs (2.26±0.80)L, (1.84±0.73) vs (2.30±0.78)L, (1.70±0.66) vs (2.38±0.76)L; FEV(1)%pred:46.2 (38.5, 53.7)% vs 80.8(66.5, 93.6)%, 60.1 (48.2, 71.6)% vs 87.4 (68.5, 96.5)%, 58.5 (48.6, 74.8)% vs 86.6 (73.0, 97.3)%] (all  P< 0.05). In the FEV(1)%pred <60% group, FEV(1) and FEV(1)%pred 1 year after treatment and 2 years after treatment were all increased compared with before treatment (all  P< 0.05). In the FEV(1)%pred ≥60% group, there was no statistical difference in FEV(1) at each time point before and after treatment (all  P> 0.05), but the FEV(1)%pred at 2 years after treatment was higher than before treatment ( P< 0.05). There were no significant differences in adverse events between the two groups (all  P> 0.05).  Conclusion:  BT can significantly improve the lung function, reduce the times of acute attack and the dosage of glucocorticoids in severe asthma patients with FEV(1)% pred<60%, which is safe and effective.",2020,"In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05).","['75 patients with asthma who were treated with BT at Shenzhen University Hospital of the Chinese Academy of Sciences from January 2016 to January 2018', 'severe asthma patients with the first second forced expiratory volume (FEV(1']","['bronchial thermoplasty (BT', 'BT', 'FEV(1)%pred']","['acute exacerbation', 'FEV(1', 'FEV(1)%pred', 'consumption of oral prednisone, the amount of budesonide inhaled, and the times of acute attack [ M  ( Q (1),  Q (3', 'lung function', 'adverse events', 'ACT score', 'glucocorticoid consumption, times of acute attack, asthma control test (ACT) score, changes in lung function, and adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]","[{'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",75.0,0.0274246,"In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200119-00127']
2278,32654554,Carbidopa for Afferent Baroreflex Failure in Familial Dysautonomia: A Double-Blind Randomized Crossover Clinical Trial.,"Afferent lesions of the arterial baroreflex occur in familial dysautonomia. This leads to excessive blood pressure variability with falls and frequent surges that damage the organs. These hypertensive surges are the result of excess peripheral catecholamine release and have no adequate treatment. Carbidopa is a selective DOPA-decarboxylase inhibitor that suppresses catecholamines production outside the brain. To learn whether carbidopa can inhibit catecholamine-induced hypertensive surges in patients with severe afferent baroreflex failure, we conducted a double-blind randomized crossover trial in which patients with familial dysautonomia received high dose carbidopa (600 mg/day), low-dose carbidopa (300 mg/day), or matching placebo in 3 4-week treatment periods. Among the 22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years). At enrollment, patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg). Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075). The 2 co-primary end points of the trial were met. The SD of systolic BP variability was reduced at both carbidopa doses (low dose: 17±4; high dose: 18±5 mm Hg) compared with placebo (23±7 mm Hg;  P =0.0013), and there was a significant reduction in the systolic BP peaks on active treatment ( P =0.0015). High- and low-dose carbidopa were similarly effective and well tolerated. This study provides class Ib evidence that carbidopa can reduce blood pressure variability in patients with congenital afferent baroreflex failure. Similar beneficial effects are observed in patients with acquired baroreflex lesions.",2020,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","['patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg', 'patients with congenital afferent baroreflex failure', 'Familial Dysautonomia', 'familial dysautonomia', '22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years', 'patients with familial dysautonomia', 'patients with severe afferent baroreflex failure', 'patients with acquired baroreflex lesions']","['placebo', 'carbidopa', 'High- and low-dose carbidopa', 'Carbidopa']","['SD of systolic BP variability', 'effective and well tolerated', 'systolic BP peaks', 'blood pressure variability']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0013364', 'cui_str': 'Familial dysautonomia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",22.0,0.236703,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Norcliffe-Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose-Alberto', 'Initials': 'JA', 'LastName': 'Palma', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15267']
2279,32654580,A Randomized Double-Blind Placebo-Control Study to Assess the Efficacy and Safety of OLNP-05 Versus Placebo for the Treatment of Subjects with Premature Ejaculation.,"Premature ejaculation (PE) is one of the foremost sex-related health problems among men. The global occurrence ranges from 20% to 30%, according to various studies. PE has a great impact on the men's quality of life, with deleterious effects such as embarrassment, frustration, and feeling of incompetence. Considering the necessity of treatment of PE, this study was planned to compare the efficacy and safety of OLNP-05 versus placebo for treating subjects suffering from PE. In this randomized clinical study, 60 men with PE were enrolled and randomly assigned to receive either OLNP-05 or placebo one capsule twice daily for a period of 8 weeks. Subjects were evaluated during visits on day 1, day 28, and day 56. Mean change from baseline in intravaginal ejaculatory latency time (IELT), improvement in premature ejaculation profile (PEP), and Clinical Global Impression-Improvement scale (CGI-I) were used to assess the efficacy of treatment.  P -value <.05 was considered significant. At the end of the treatment, the improvement in IELT score in the OLNP-05 group was remarkably higher than the placebo. Subjects in the OLNP-05 treatment group also reported significantly greater improvement in PEP subscale score. Majority of OLNP-05-treated subjects were found to be in the ""much improved"" category as per CGI-I assessment. The result confirms the safety and efficacy of OLNP-05, therefore suggesting that OLNP-05 may be a safe and effective intervention for the management of PE.  Trial registration:  Clinical Trials Registry India (Registration No: CTRI/2017/08/009226, 02/08/2017).",2020,"At the end of the treatment, the improvement in IELT score in the OLNP-05 group was remarkably higher than the placebo.","['Subjects with Premature Ejaculation', '60 men with PE', 'subjects suffering from PE']","['OLNP-05 versus placebo', 'Placebo', 'OLNP-05 or placebo', 'OLNP-05', 'PE', 'placebo']","['PEP subscale score', 'efficacy and safety', 'Premature ejaculation (PE', 'IELT score', 'intravaginal ejaculatory latency time (IELT), improvement in premature ejaculation profile (PEP), and Clinical Global Impression-Improvement scale (CGI-I']","[{'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}]","[{'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",60.0,0.168967,"At the end of the treatment, the improvement in IELT score in the OLNP-05 group was remarkably higher than the placebo.","[{'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Panda', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}, {'ForeName': 'Somashekara', 'Initials': 'S', 'LastName': 'Nirvanashetty', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}, {'ForeName': 'Vivek A', 'Initials': 'VA', 'LastName': 'Parachur', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}, {'ForeName': 'Nilima', 'Initials': 'N', 'LastName': 'Mohanty', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}]",Journal of medicinal food,['10.1089/jmf.2019.4661']
2280,32654588,Effects of aerobic exercise and cognitively engaging exercise on cardiorespiratory fitness and motor skills in primary school children: A cluster randomized controlled trial.,"This paper examined effects of two interventions on cardiorespiratory fitness and motor skills, and whether these effects are influenced by baseline levels, and dose of moderate-to-vigorous physical activity (MVPA) during the intervention. A cluster randomized controlled trial was implemented in 22 schools (n = 891; 9.2 ± 07 years). Intervention groups received aerobic or cognitively engaging exercise (14-weeks, four lessons per week). Control groups followed their regular physical education programme. Cardiorespiratory fitness, motor skills and MVPA were assessed. Multilevel analysis showed no main effects on cardiorespiratory fitness and motor skills although the amount of MVPA was higher in the aerobic than in the cognitively engaging and control group. Intervention effects did not depend on baseline cardiorespiratory fitness and motor skills. Children with a higher dose of MVPA within the intervention groups had better cardiorespiratory fitness after both interventions and better motor skills after the cognitively engaging intervention. In conclusion, the interventions were not effective to enhance cardiorespiratory fitness and motor skills at a group level, possibly due to large individual differences and to a total dose of MVPA too low to find effects. However, the amount of MVPA is an important factor that influence the effectiveness of interventions.",2020,Children with a higher dose of MVPA within the intervention groups had better cardiorespiratory fitness after both interventions and better motor skills after the cognitively engaging intervention.,"['primary school children', '22 schools (n\xa0=\xa0891; 9.2\xa0±\xa007\xa0years']","['MVPA', 'aerobic exercise and cognitively engaging exercise', 'aerobic or cognitively engaging exercise', 'regular physical education programme']","['Cardiorespiratory fitness, motor skills and MVPA', 'MVPA', 'motor skills', 'cardiorespiratory fitness and motor skills', 'baseline cardiorespiratory fitness and motor skills', 'cardiorespiratory fitness']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0403646,Children with a higher dose of MVPA within the intervention groups had better cardiorespiratory fitness after both interventions and better motor skills after the cognitively engaging intervention.,"[{'ForeName': 'Irene M J', 'Initials': 'IMJ', 'LastName': 'van der Fels', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hartman', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Bosker', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Johannes W', 'Initials': 'JW', 'LastName': 'de Greeff', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Anne G M', 'Initials': 'AGM', 'LastName': 'de Bruijn', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Meijer', 'Affiliation': 'Clinical Neuropsychology Section, Vrije Universiteit , Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': ""Amsterdam Medical Center, Emma Children's Hospital , Amsterdam, The Netherlands.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Visscher', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen , Groningen, The Netherlands.'}]",Journal of sports sciences,['10.1080/02640414.2020.1765464']
2281,32654610,Ipsilateral vs Contralateral Presentation of Familiarization Trials in a Lower-Limb Proprioception Test.,"We examined the effect of pretest familiarization with ipsilateral or contralateral limbs on the performance in a proprioception test conducted afterwards. Sixty adults were randomly assigned to six different familiarization-session patterns. Ankle proprioception was tested using active movement extent discrimination assessment. The results reflected a beneficial effect of familiarization session on performance in the subsequent proprioception test (ES = 0.777). However, no significant difference was found between proprioceptive acuity scores when familiarization and test happened with either ipsilateral or contralateral limbs (ES= 0.361), or between the tested left and right foot no matter which side was familiarized (ES = 0.343). These results suggest that proprioceptive information from the familiarization session facilitates the subsequent proprioception test and is equally available to both hemispheres without loss of quality.",2020,The results reflected a beneficial effect of familiarization session on performance in the subsequent proprioception test (ES = 0.777).,['Sixty adults'],['pretest familiarization with ipsilateral or contralateral limbs'],"['Ankle proprioception', 'proprioceptive acuity scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0401017,The results reflected a beneficial effect of familiarization session on performance in the subsequent proprioception test (ES = 0.777).,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'International Education School, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Faculty of Health, University of Canberra, Canberra, Australia.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Waddington', 'Affiliation': 'Faculty of Health, University of Canberra, Canberra, Australia.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Faculty of Health, University of Canberra, Canberra, Australia.'}]",Journal of motor behavior,['10.1080/00222895.2020.1777929']
2282,32642594,The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial.,"Nearly all individuals with Down Syndrome (DS) display pathology associated with Alzheimer's disease (AD) beginning as early as age 30. Previous research in typically developed adults suggests that increased moderate-to-vigorous physical activity (MVPA) may improve cognitive function and protect against age-related structural and functional changes in the brain; however, the potential impact of increased MVPA on the development of AD in adults with DS has not been evaluated. Despite the potential positive impact of MVPA on cognition and AD risk, participation in MVPA among young adults with DS is low. The limited research evaluating strategies for increasing MVPA in adults with DS has been unsuccessful in increasing MVPA. Results from our preliminary investigation where we remotely delivered real-time MVPA, led by a trained health educator, to groups of adults with DS in their homes via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function. However, the sustainability, impact on total daily MVPA, optimal session frequency, and potential impacts on cognitive function and brain health of remotely delivered group MVPA sessions in adults with DS are unknown. Therefore, we will conduct a trial in 80 non-demented adults with DS to determine the feasibility and potential efficacy of remotely delivered group MVPA sessions to increase daily MVPA, relative to a usual care control. Secondarily we will assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function and brain parameters related to AD.
NCT registration


NCT04048759.",2020,"Results from our preliminary investigation where we remotely delivered real-time MVPA, led by a trained health educator, to groups of adults with DS in their homes via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function.","['young adults with DS', ""Nearly all individuals with Down Syndrome (DS) display pathology associated with Alzheimer's disease (AD) beginning as early as age 30"", '80 non-demented adults with DS', 'adults with DS', 'adults with Down Syndrome']","['MVPA', 'MVPA sessions']","['cognition and AD risk, participation in MVPA', 'total daily MVPA, optimal session frequency, and potential impacts on cognitive function and brain health', 'cognitive function', 'cardiovascular fitness, quality of life, cognitive function and brain parameters related to AD']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",80.0,0.0408096,"Results from our preliminary investigation where we remotely delivered real-time MVPA, led by a trained health educator, to groups of adults with DS in their homes via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function.","[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Lepping', 'Affiliation': 'Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Phill', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Forsha', 'Affiliation': ""Ward Family Heart Center, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Sherman', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Danon', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100607']
2283,32644104,Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer: A Post Hoc Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial.,"Importance


Despite numerous published phase 3 trials, the association of treatment adherence with outcomes for patients with rectal cancer remains largely unexplored.
Objective


To analyze the association of treatment adherence with disease-free survival (DFS) among patients with rectal cancer in the CAO/ARO/AIO-04 trial.
Design, Setting, and Participants


This post hoc analysis of a phase 3 randomized clinical trial was conducted from July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma. Statistical analysis was performed from May 5, 2019, to February 2, 2020.
Interventions


A total of 625 patients received neoadjuvant fluorouracil-based chemoradiotherapy (nCRT), and a total of 607 patients received fluorouracil-based nCRT with addition of oxaliplatin. Of the 1126 patients who underwent curative surgery, 439 started fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin.
Main Outcomes and Measures


The association of adherence with nCRT and adjuvant chemotherapy with DFS was assessed in both groups in the as-treated population.
Results


Among the 625 patients (442 men; mean age, 63.0 years) who received fluorouracil nCRT and the 607 patients (430 men; mean age, 63.0 years) who received fluorouracil-based nCRT with addition of oxaliplatin, after a median follow-up of 50 months (interquartile range, 38-61 months), 3-year DFS in the as-treated population was 71.1% in the fluorouracil group and 75.8% in the fluorouracil-oxaliplatin group (hazard ratio [HR], 0.803; 95% CI, 0.651-0.990; P = .04). Overall, 419 patients in the fluorouracil nCRT group (67.0%) and 434 patients in the fluorouracil-oxaliplatin nCRT group (71.5%) received full doses of preoperative nCRT. Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the fluorouracil-oxaliplatin group (32.0%) received full doses of adjuvant chemotherapy. Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses. In contrast, adjuvant chemotherapy was not associated with DFS in both the fluorouracil group (complete vs near complete: HR, 0.900; 95% CI, 0.559-1.448; P = .66; complete vs incomplete: HR, 1.057; 95% CI, 0.807-1.386; P = .69) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.155; 95% CI, 0.716-1.866; P = .56; complete vs incomplete: HR, 1.073; 95% CI, 0.790-1,457; P = .65).
Conclusions and Relevance


To our knowledge, this is the first analysis of a phase 3 trial to assess the association of treatment adherence with some clinical outcomes for patients with rectal cancer. The findings emphasize the need for appropriate trial design with optimized nCRT dose and schedule and supportive strategies to facilitate good adherence and precision delivery, especially for intensified nCRT.
Trial Registration


ClinicalTrials.gov Identifier: NCT00349076.",2020,"Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses.","['patients with rectal cancer in the CAO/ARO/AIO-04 trial', '625 patients (442 men; mean age, 63.0 years) who received', 'patients with rectal cancer', '419 patients in the', 'July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma', 'Patients With Rectal Cancer', 'Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the', '1126 patients who underwent curative surgery, 439 started', '625 patients received', 'and the 607 patients (430 men; mean age, 63.0 years) who received']","['fluorouracil-based nCRT with addition of oxaliplatin', 'fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin', 'fluorouracil-oxaliplatin', 'fluorouracil-oxaliplatin nCRT', 'fluorouracil', 'adjuvant chemotherapy', 'fluorouracil nCRT', 'neoadjuvant fluorouracil-based chemoradiotherapy (nCRT']","['association of adherence with nCRT and adjuvant chemotherapy with DFS', '3-year DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}]",625.0,0.204208,"Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Diefenhardt', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Ethan B', 'Initials': 'EB', 'LastName': 'Ludmir', 'Affiliation': 'Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Department of Medical Oncology, University Hospital Mannheim, University Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral, and Pediatric Surgery, University Medical Center, Göttingen, Germany.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Minsky', 'Affiliation': 'Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2394']
2284,32644110,Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial.,"Importance


A significant proportion of patients with early-stage triple-negative breast cancer (TNBC) are treated with neoadjuvant chemotherapy. Sequencing of circulating tumor DNA (ctDNA) after surgery, along with enumeration of circulating tumor cells (CTCs), may be used to detect minimal residual disease and assess which patients may experience disease recurrence.
Objective


To determine whether the presence of ctDNA and CTCs after neoadjuvant chemotherapy in patients with early-stage TNBC is independently associated with recurrence and clinical outcomes.
Design, Setting, and Participants


A preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive postneoadjuvant genomically directed therapy vs treatment of physician choice. Patients had blood samples collected for ctDNA and CTCs at time of treatment assignment; ctDNA analysis with survival was performed for 142 patients, and CTC analysis with survival was performed for 123 patients. Median clinical follow-up was 17.2 months (range, 0.3-58.3 months).
Interventions


Circulating tumor DNA was sequenced using the FoundationACT or FoundationOneLiquid Assay, and CTCs were enumerated using an epithelial cell adhesion molecule-based, positive-selection microfluidic device.
Main Outcomes and Measures


Primary outcomes were distant disease-free survival (DDFS), disease-free survival (DFS), and overall survival (OS).
Results


Among 196 female patients (mean [SD] age, 49.6 [11.1] years), detection of ctDNA was significantly associated with inferior DDFS (median DDFS, 32.5 months vs not reached; hazard ratio [HR], 2.99; 95% CI, 1.38-6.48; P = .006). At 24 months, DDFS probability was 56% for ctDNA-positive patients compared with 81% for ctDNA-negative patients. Detection of ctDNA was similarly associated with inferior DFS (HR, 2.67; 95% CI, 1.28-5.57; P = .009) and inferior OS (HR, 4.16; 95% CI,1.66-10.42; P = .002). The combination of ctDNA and CTCs provided additional information for increased sensitivity and discriminatory capacity. Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009). At 24 months, DDFS probability was 52% for patients who were ctDNA positive and CTC positive compared with 89% for those who were ctDNA negative and CTC negative. Similar trends were observed for DFS (HR, 3.15; 95% CI, 1.07-9.27; P = .04) and OS (HR, 8.60; 95% CI, 1.78-41.47; P = .007).
Conclusions and Relevance


In this preplanned secondary analysis of a randomized clinical trial, detection of ctDNA and CTCs in patients with early-stage TNBC after neoadjuvant chemotherapy was independently associated with disease recurrence, which represents an important stratification factor for future postneoadjuvant trials.
Trial Registration


ClinicalTrials.gov Identifier: NCT02101385.",2020,"Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009).","['With Triple-Negative Breast Cancer', 'Patients', 'patients with early-stage TNBC', 'patients with early-stage TNBC after', '196 female patients (mean [SD] age, 49.6 [11.1] years', 'Participants\n\n\nA preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive postneoadjuvant genomically directed therapy vs treatment of physician choice', 'patients with early-stage triple-negative breast cancer (TNBC']",['neoadjuvant chemotherapy'],"['DDFS probability', 'inferior DDFS', 'Circulating Tumor DNA and Circulating Tumor Cells', 'distant disease-free survival (DDFS), disease-free survival (DFS), and overall survival (OS']","[{'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",196.0,0.30666,"Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009).","[{'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Radovich', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Guanglong', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Hancock', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chitambar', 'Affiliation': 'Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Falkson', 'Affiliation': 'University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Filipa C', 'Initials': 'FC', 'LastName': 'Lynce', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Blaya', 'Affiliation': 'Memorial Healthcare System, Hollywood, Florida.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Walling', 'Affiliation': 'Community Regional Cancer Care, Indianapolis, Indiana.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Daily', 'Affiliation': 'University of Florida, Gainesville.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Mahtani', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Deerfield Beach, Florida.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Advocate Aurora Health Care, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Graham', 'Affiliation': 'Erlanger Health System, Chattanooga, Tennessee.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Dean C', 'Initials': 'DC', 'LastName': 'Pavlick', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Albacker', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gregg', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Solzak', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Casey L', 'Initials': 'CL', 'LastName': 'Bales', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Cantor', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Anna Maria V', 'Initials': 'AMV', 'LastName': 'Storniolo', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Badve', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Tarah J', 'Initials': 'TJ', 'LastName': 'Ballinger', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Chun-Li', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Savran', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2295']
2285,32647083,Infusing the axioms of clinical reasoning while designing clinical anatomy case vignettes teaching for novice medical students: a randomised cross over study.,"The clinical reasoning skills is often gained when the biomedical knowledge is broadened and deepened alongside exposure to patients. The 'ideal' blend of axioms of clinical reasoning and case based learning would establish the pedagogical bridges right from the first year of medical education. So this study aimed to investigate the perceived importance and efficacy of teaching clinical reasoning skills among first year medical students, as this has not previously been described. As a priori, two clinical reasoning skill sessions were conducted using clinico-anatomical case vignettes designed according to the literature regarding clinical reasoning ('serial cue' approach and hypothetico-deduction). Students were divided into intervention and control group and crossed over in subsequent sessions. Analysis was done by mixed method approach including measuring proof of benefit using post-test comparison, quantitative survey and qualitative analysis by nominal group discussion. Post test scores were compared using student's  t -test. Feedbacks were analysed using descriptive statistics. The results showed that post test scores were significantly higher in intervention group than the control group in both sessions ( P <0.001, 0.016). A total of 66% students felt, diagnostic skills and lateral thinking abilities were improved and It helped in developing problem-solving abilities for 67% students. clinico-anatomical case vignettes helped in understanding anatomical basis of clinical conditions for 61% students. To conclude, introducing clinical reasoning has considerable effect in improving the decision making ability of the students and if incorporated right from the first year, would better prepare the students in successful transition to clinical learning environment.",2020,"A total of 66% students felt, diagnostic skills and lateral thinking abilities were improved and It helped in developing problem-solving abilities for 67% students.","['first year medical students', 'novice medical students']",[],"['diagnostic skills and lateral thinking abilities', 'problem-solving abilities']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233631', 'cui_str': 'Lateral thinking'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",,0.0186841,"A total of 66% students felt, diagnostic skills and lateral thinking abilities were improved and It helped in developing problem-solving abilities for 67% students.","[{'ForeName': 'Dinesh Kumar', 'Initials': 'DK', 'LastName': 'V', 'Affiliation': 'Department of Anatomy, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Rajprasath', 'Initials': 'R', 'LastName': 'R', 'Affiliation': 'Department of Anatomy, Pondicherry Institute of Medical Sciences, Puducherry, India.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Priyadharshini', 'Affiliation': 'Department of Anatomy, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, India.'}, {'ForeName': 'Magi', 'Initials': 'M', 'LastName': 'Murugan', 'Affiliation': 'Department of Anatomy, Pondicherry Institute of Medical Sciences, Puducherry, India.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Devi', 'Affiliation': 'Department of Anatomy, Pondicherry Institute of Medical Sciences, Puducherry, India.'}]",Anatomy & cell biology,['10.5115/acb.19.199']
2286,32648175,Completely Minimally Invasive Esophagectomy Versus Hybrid Esophagectomy for Esophageal and Gastroesophageal Junctional Cancer: Clinical and Short-Term Oncological Outcomes.,"BACKGROUND


Minimally invasive surgery for resectable esophageal and gastroesophageal junctional (GEJ) cancer significantly reduces morbidity when compared with open surgery, as is evident from published landmark trials. Comparison of outcomes between hybrid esophagectomy (HE) and completely minimally invasive esophagectomy (CMIE) remains unclear.
OBJECTIVE


We aimed to ascertain whether CMIE is associated with less postoperative complications compared with HE without oncological compromise.
METHODS


All consecutive two-stage HEs and CMIEs performed between 2016 and 2018 were included. All procedures were performed with an intrathoracic anastomosis. Primary clinical outcomes were pulmonary infective and overall complications within 30 days of surgery, while primary oncological outcomes included overall survival (OS) and disease-free survival (DFS) at both 6 months and to date. Secondary outcomes included intraoperative variables and postoperative clinical parameters.
RESULTS


Overall, 98 patients had CMIEs and 49 patients had HEs. There were no baseline differences between the two groups. Thirty-day postoperative pulmonary infection rates were lower in the CMIE group compared with the HE group (12.2% vs. 28.6%; p = 0.014), and 30-day overall postoperative complication rates were also lower following CMIE (35.7% vs. 59.2%; p = 0.007). OS and DFS were similar between the two groups at 6 months (p = 0.201 and p = 0.109, respectively).
CONCLUSIONS


CMIE is associated with less pulmonary infective and overall postoperative complications compared with HE for resectable esophageal and GEJ cancer. No intergroup difference was observed regarding short-term survival and cancer recurrence in patients undergoing CMIE and HE. A randomized controlled trial comparing the two operative approaches is required to validate these findings.",2020,CMIE is associated with less pulmonary infective and overall postoperative complications compared with HE for resectable esophageal and GEJ cancer.,"['All consecutive two-stage HEs and CMIEs performed between 2016 and 2018 were included', 'Esophageal and Gastroesophageal Junctional Cancer', '98 patients had CMIEs and 49 patients had HEs']","['hybrid esophagectomy (HE) and completely minimally invasive esophagectomy (CMIE', 'CMIE', 'Minimally Invasive Esophagectomy Versus Hybrid Esophagectomy']","['short-term survival and cancer recurrence', 'OS and DFS', 'intraoperative variables and postoperative clinical parameters', 'pulmonary infective and overall complications', 'overall survival (OS) and disease-free survival (DFS', '30-day overall postoperative complication rates', 'pulmonary infective and overall postoperative complications', 'Thirty-day postoperative pulmonary infection rates']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}]",,0.286259,CMIE is associated with less pulmonary infective and overall postoperative complications compared with HE for resectable esophageal and GEJ cancer.,"[{'ForeName': 'Krashna', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK. krashna@doctors.org.uk.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Abbassi', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Cheuk Bong', 'Initials': 'CB', 'LastName': 'Tang', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lorenzi', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Charalabopoulos', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Sritharan', 'Initials': 'S', 'LastName': 'Kadirkamanathan', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Naga Venkatesh', 'Initials': 'NV', 'LastName': 'Jayanthi', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}]",Annals of surgical oncology,['10.1245/s10434-020-08826-7']
2287,32648924,Association of Adherence to Weight Telemonitoring With Health Care Use and Death: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Adherence to telemonitoring may be associated with heart failure exacerbation but is not included in telemonitoring algorithms.
Objective


To assess whether telemonitoring adherence is associated with a patient's risk of hospitalization, emergency department visit, or death.
Design, Setting, and Participants


This post hoc secondary analysis of the Better Effectiveness After Transition-Heart Failure randomized clinical trial included patients from 6 academic medical centers in California who were eligible if they were hospitalized for decompensated heart failure and excluded if they were discharged to a skilled nursing facility, were expected to improve because of a medical procedure, or did not have the cognitive or physical ability to participate. The trial compared a telemonitoring intervention with usual care for patients with heart failure after hospital discharge from October 12, 2011, to September 30, 2013. Data analysis was performed from November 8, 2016, to May 10, 2019.
Interventions


The intervention group (n = 722) received heart failure education, telephone check-ins, and a wireless telemonitoring system that allowed the patient to transmit weight, blood pressure, heart rate, and selected symptoms. The control group (n = 715) received usual care. Patients were followed up for 180 days after discharge.
Main Outcomes and Measures


The main outcome was within-person risk of hospitalization, emergency department visit, or death by week during the study period. Poisson regression was used to determine the within-person association of adherence to daily weighing with the risk of experiencing these events in the following week.
Results


Among the 538 participants (mean [SD] age, 70.9 [14.1] years; 287 [53.8%] male; 269 [50.7%] white) in the present analysis, adherence was lowest during the first week after enrollment but steadily increased, peaking between days 26 and 60 at 69%, or 371 transmissions. Adherence to weight telemonitoring was associated with events in the following week; an increase in adherence by 1 day was associated with a 19% decrease in the rate of death in the following week (incidence rate ratio, 0.81; 95% CI, 0.73-0.90) and an 11% decrease in the rate of hospitalization (incidence rate ratio, 0.89; 95% CI, 0.86-0.91). Adherence in the previous week was not associated with reduced rates of emergency department visits (incidence rate ratio, 0.95; 95% CI, 0.90-1.02).
Conclusions and Relevance


In this study, lower adherence to weight telemonitoring in a given week was associated with an increased risk of subsequent hospitalization or death in the following week. It is unlikely that this is a result of the telemonitoring intervention; rather, adherence may be an important factor associated with a patient's health status.",2020,"Adherence in the previous week was not associated with reduced rates of emergency department visits (incidence rate ratio, 0.95; 95% CI, 0.90-1.02).
","['patients with heart failure after hospital discharge from October 12, 2011, to September 30, 2013', 'patients from 6 academic medical centers in California who were eligible if they were hospitalized for decompensated heart failure and excluded if they were discharged to a skilled nursing facility, were expected to improve because of a medical procedure, or did not have the cognitive or physical ability to participate', '538 participants (mean [SD] age, 70.9 [14.1] years; 287 [53.8%] male; 269 [50.7%] white', 'Death']","['telemonitoring intervention with usual care', 'heart failure education, telephone check-ins, and a wireless telemonitoring system', 'usual care']","['adherence', 'person risk of hospitalization, emergency department visit, or death', 'rate of death', 'risk of subsequent hospitalization or death', 'rate of hospitalization', 'Adherence to weight telemonitoring', 'rates of emergency department visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C1272747', 'cui_str': 'Expected to improve'}, {'cui': 'C0199171', 'cui_str': 'Medical procedure'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1828111', 'cui_str': 'Heart failure education'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.230963,"Adherence in the previous week was not associated with reduced rates of emergency department visits (incidence rate ratio, 0.95; 95% CI, 0.90-1.02).
","[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Haynes', 'Affiliation': 'Center for Health and Technology, Department of Pediatrics, University of California, Davis, Sacramento.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Center for Healthcare Policy and Research, Department of Pediatrics, University of California, Davis, Sacramento.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tong', 'Affiliation': 'Adventist Heart and Vascular Institute, St Helena, California.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hoch', 'Affiliation': 'Center for Healthcare Policy and Research, Department of Public Health Sciences, University of California, Davis, Sacramento.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, University of California, Los Angeles.'}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Ganiats', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego School of Medicine, La Jolla.'}, {'ForeName': 'Lorraine S', 'Initials': 'LS', 'LastName': 'Evangelista', 'Affiliation': 'Sue and Bill Gross School of Nursing, University of California, Irvine.'}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': 'Department of Orthopaedics, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': 'Department of Medicine, University of California, San Francisco School of Medicine, San Francisco.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Romano', 'Affiliation': 'Center for Healthcare Policy and Research, Division of General Medicine, University of California, Davis, Sacramento.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.10174']
2288,32645095,The effects of static stretching programs on muscle strength and muscle architecture of the medial gastrocnemius.,"INTRODUCTION


Static stretching (SS) program are widely used in clinical and athletic settings. Many previous studies investigate the effect of SS program on muscle strength and muscle architecture (muscle thickness, and pennation angleh). However, no consensus has been reached about the effect of SS programs on muscle strength and muscle architecture. The aim of this study was to investigate the effects of 6-week SS programs performed at different weekly frequencies on muscle strength, muscle thickness and pennation angle at different ankle joint positions.
METHODS


A total of 24 healthy male volunteers were performed 6-week SS programs (2,160 s of SS: 360 s/week*6 weeks) and were randomized to a group that performed SS once a week, or a group that performed SS three times per week. Total time under stretching was equated between groups. The muscle strength (maximum voluntary isometric contraction) at three different ankle joints were assessed before and after the 6-week SS program. In addition, muscle thickness and pennation angle were assessed by ultrasonography before and after 6-week SS program.
RESULTS


There were no significant changes in all variables before and after the 6-week SS program, regardless of weekly frequency (p > 0.05).
CONCLUSIONS


Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.",2020,"Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.",['24 healthy male volunteers'],"['Static stretching (SS) program', 'static stretching programs', 'SS program', 'SS programs']","['muscle strength (maximum voluntary isometric contraction', 'Total time under stretching', 'muscle strength and muscle architecture of the medial gastrocnemius', 'muscle strength, muscle thickness and pennation angle', 'muscle strength or muscle architecture', 'muscle strength and muscle architecture (muscle thickness, and pennation angleh']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",24.0,0.0105047,"Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.","[{'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Kakeru', 'Initials': 'K', 'LastName': 'Hiraizumi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kiyono', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Taizan', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Nishishita', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}]",PloS one,['10.1371/journal.pone.0235679']
2289,32645109,"A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan.","BACKGROUND


Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
METHODS AND FINDINGS


A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints.
CONCLUSIONS


Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230).
TRIAL REGISTRATION


The trial is registered at ISRCTN, trial number ISRCTN30393230.",2020,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","['children aged 6-59 months', 'in Kenya and South Sudan', 'acute malnutrition in children 6-59 months (ComPAS trial', 'From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male', 'Kenya and South Sudan']","['combined protocol against standard care', 'SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF']","['cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains', 'nutritional recovery']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C3273373', 'cui_str': 'South Sudan'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517590', 'cui_str': '16.7'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}]",2071.0,0.180003,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lelijveld', 'Affiliation': 'No Wasted Lives, Action Against Hunger UK, London, United Kingdom.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Marron', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Onyo', 'Affiliation': 'Action Against Hunger, Juba, South Sudan.'}, {'ForeName': 'Eunice N', 'Initials': 'EN', 'LastName': 'Musyoki', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Adongo', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Department of International Health, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Kerac', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003192']
2290,32645162,Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.,"BACKGROUND


Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS


The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS


A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS


There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","['HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk', 'people living with HIV', '7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers']",['nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI)\u2005plus nonnucleoside reverse-transcriptase inhibitor'],"['GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts', 'entry CD4 cell count and CD4/CD8 ratio', 'median CD4 T-cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4277729', 'cui_str': 'Global Burden of Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",7770.0,0.18883,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leon-Cruz', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic and University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Breno Riegel', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil.'}, {'ForeName': 'Yvetot', 'Initials': 'Y', 'LastName': 'Joseph', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haiti.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Siminski', 'Affiliation': 'Frontier Science and Technology Foundation, Amherst, Massachusetts, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'HIV Medical Sciences, Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Montgomery, Alabama, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa259']
2291,32645164,An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus.,"BACKGROUND


Chronic kidney disease is a common comorbid condition among persons living with human immunodeficiency virus (PWH). We characterized baseline kidney function in the REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial cohort.
METHODS


REPRIEVE enrolled PWH with low to moderate cardiovascular risk based on traditional risk factors to evaluate the effect of statin therapy on cardiovascular events. We determined baseline estimated glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations, and we evaluated baseline factors associated with eGFR <90 mL/min/1.73 m2 by logistic regression. We performed Bland-Altman plots and scatterplots to assess agreement between equations.
RESULTS


Among 7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the median body mass index (calculated as calculated as weight in kilograms divided by height in meters squared) was 25.8, and the median CD4 cell count 620/µL. The median CKD-EPI eGFR was 97 mL/min/1.73 m2, and 38% had an eGFR <90 mL/min/1.73 m2. In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate. The CKD-EPI and Modification of Diet in Renal Disease equations demonstrated strong agreement, particularly at lower eGFR values. Overall, there was 56% concordance between the 3 equations (categories <60, 60 to <90, ≥90 mL/min), improving to 73% after accounting for individual body surface area.
CONCLUSIONS


REPRIEVE enrolled a diverse cohort including a substantial number of PWH with reduced kidney function. Factors associated with reduced eGFR included traditional risk factors and tenofovir disoproxil fumarate exposure. Three commonly used equations have only fair agreement, with potential implications for both clinical care and epidemiologic studies.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","['7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the', 'Human Immunodeficiency Virus', 'persons living with human immunodeficiency virus (PWH']","['tenofovir disoproxil fumarate exposure', 'statin therapy', 'eGFR', 'tenofovir disoproxil fumarate', 'Pitavastatin']","['median CKD-EPI eGFR', 'median CD4 cell count', 'median body mass index', 'glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations', 'cardiovascular events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",7770.0,0.0804019,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'HIV Treatment Clinical Research Site, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Mosepele', 'Initials': 'M', 'LastName': 'Mosepele', 'Affiliation': 'University of Botswana and Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Lerato', 'Initials': 'L', 'LastName': 'Mohapi', 'Affiliation': 'Soweto Clinical Research Site, Chris Hani Baragwanath Hospital, Johannesburg, Gauteng, South Africa.'}, {'ForeName': 'Sandra Wagner', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Fiocruz Therapeutic and Prevention HIV/AIDS Clinical Trials Unit, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Marcus V G', 'Initials': 'MVG', 'LastName': 'de Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Doutor Heitor Viera Dourado, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McComsey', 'Affiliation': 'Division of Pediatric Infectious Diseases and Rheumatology, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Wyatt', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa222']
2292,32646462,"Corifollitropin alfa for poor responders patients, a prospective randomized study.","BACKGROUND


Poor ovarian response remains one of the biggest challenges for reproductive endocrinologists. The introduction of corifollitropin alpha (CFA) offered an alternative option to other gonadotropins for its longer half-life, its more rapid achievement of the threshold and higher FSH levels. We compared two different protocols with CFA, a long agonist and a short antagonist, and a no-CFA protocol.
METHODS


Patients enrolled fulfilled at least two of the followings: AFC < 5, AMH < 1,1 ng/ml, less than three oocytes in a previous cycle, age > 40 years. Ovarian stimulation with an antagonist protocol was performed either with 300 UI rFSH and 150 UI rLH or 300UI HMG. In the long agonist group, after pituitary suppression with triptorelin, CFA was given the 1-2th day of cycle and 300 UI rFSH and 150 UI rLH the 5th day. In the short antagonist group CFA was given the 1-2th day of cycle and 300 UI rFSH and 150 UI rLH the 5th day. The primary objective was the effect on the number of oocytes and MII oocytes. Secondary objective were pregnancy rates, ongoing pregnancies and ongoing pregnancies per intention to treat.
RESULTS


The use of CFA resulted in a shorter lenght of stimulation and a lower number of suspended treatments. Both the CFA protocols were significantly different from the no-CFA group in the number of retrieved oocytes (p < 0,05), with a non-significant difference in favour of the long agonist protocol. Both CFA groups yielded higher pregnancy rates, especially the long protocol, due to the higher number of oocytes retrieved (p < 0,05), as implantation rates did not differ. The cumulative pregnancy rate was also different, due to the higher number of cryopreserved blastocysts (p < 0,02).
CONCLUSIONS


The long agonist protocol with the addition of rFSH and rLH showed the best results in all the parameters. A short antagonist protocol with CFA was less effective, but not significantly, although provided better results compared to the no-CFA group. We suggest that a long agonist protocol with CFA and recombinant gonadotropins might be a valuable option for poor responders.
TRIAL REGISTRATION


The study was approved by the local Ethics Committee (EudraCT2015-002817-31).",2020,"Both the CFA protocols were significantly different from the no-CFA group in the number of retrieved oocytes (p < 0,05), with a non-significant difference in favour of the long agonist protocol.","['Patients enrolled fulfilled at least two of the followings', 'poor responders patients']","['rFSH and rLH', 'corifollitropin alpha (CFA', 'CFA', 'AFC <\u20095, AMH', 'triptorelin, CFA', 'Corifollitropin alfa', 'CFA and recombinant gonadotropins']","['cumulative pregnancy rate', 'pregnancy rates, ongoing pregnancies and ongoing pregnancies per intention to treat', 'implantation rates', 'pregnancy rates', 'number of oocytes and MII oocytes', 'number of retrieved oocytes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C2713522', 'cui_str': 'corifollitropin alfa'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.116864,"Both the CFA protocols were significantly different from the no-CFA group in the number of retrieved oocytes (p < 0,05), with a non-significant difference in favour of the long agonist protocol.","[{'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Fusi', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy. ffusi@asst-pg23.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zanga', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arnoldi', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Melis', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cappato', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Candeloro', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Pasqua', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}]",Reproductive biology and endocrinology : RB&E,['10.1186/s12958-020-00628-6']
2293,32646482,Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial.,"BACKGROUND


Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance with onset or first recognition during pregnancy, which is characterized by an increased insulin resistance. Gestational diabetes mellitus is associated with pregnancy-related maternal and fetal morbidity (both antenatal and perinatal). Myo-inositol has been suggested to improve insulin resistance in women with polycystic ovary syndrome. The aim of this study is to examine the impact of myo-inositol supplementation during pregnancy on the incidence of gestational diabetes mellitus.
METHODS


We will conduct a single-center, open-label, randomized controlled trial. A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80). The intervention group will receive myo-inositol and folic acid (4000 mg myo-inositol and 400 mcg folic acid daily) from 11 to 13 +6  weeks of gestation until 26-28 weeks of gestation, while the control group will receive folic acid alone (400 mcg folic acid daily) for the same period of time as intervention group. The primary outcome will be gestational diabetes incidence rate at 26-28 weeks of gestation, according to the results of a 75 g oral glucose tolerance test held at 26-28 weeks of gestation. The secondary outcomes will include fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy at 26-28 weeks of gestation.
DISCUSSION


This trial will provide evidence for the effectiveness of myo-inositol supplementation during pregnancy in reducing the incidence of gestational diabetes mellitus.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN16142533 . Registered on 9 March 2017.",2020,A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80).,"['gestational diabetes mellitus', '160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation', 'women with polycystic ovary syndrome', 'Gestational diabetes mellitus', 'Gestational diabetes mellitus (GDM']","['myo-inositol and folic acid (4000\u2009mg myo-inositol and 400\xa0mcg folic acid daily', 'folic acid alone', 'dietary myo-inositol supplementation', 'myo-inositol supplementation']","['insulin resistance', 'fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy', 'gestational diabetes incidence rate']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]",160.0,0.176481,A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80).,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Asimakopoulos', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece. asimakopoulos.geo5@gmail.com.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Pergialiotis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Anastasiou', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Antsaklis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Theodora', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Vogiatzi', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Aggela', 'Initials': 'A', 'LastName': 'Kallergi', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sindos', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Loutradis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Daskalakis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}]",Trials,['10.1186/s13063-020-04561-2']
2294,32646498,"Tofogliflozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study.","BACKGROUND


This study aimed to investigate the preventive effects of tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT).
METHODS


This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofogliflozin treatment group (n = 169) or conventional treatment group using drugs other than SGLT2 inhibitors (n = 171). Primary outcomes were changes in mean and maximum common carotid IMT measured by echography during a 104-week treatment period.
RESULTS


In a mixed-effects model for repeated measures, the mean IMT of the common carotid artery (mean-IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), significantly declined in both the tofogliflozin (- 0.132 mm, SE 0.007; - 0.163 mm, SE 0.013; - 0.170 mm, SE 0.020, respectively) and the control group (- 0.140 mm, SE 0.006; - 0.190 mm, SE 0.012; - 0.190 mm, SE 0.020, respectively). Furthermore, the tofogliflozin and the conventional treatment group did not significantly differ in the progression of the mean-IMT-CCA (mean change (95% CI) 0.008 (- 0.009, 0.025) mm, P = 0.34), along with the right (mean change (95% CI) 0.027 (- 0.005, 0.059) mm, P = 0.10) and the left max-IMT-CCA (mean change (95% CI) 0.020 (- 0.030, 0.070), P = 0.43). Similar findings were obtained even after adjusting for traditional CV risk factors and/or administration of drugs at baseline. Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C. The total and serious adverse events incidences did not significantly vary between the treatment groups.
CONCLUSIONS/INTERPRETATION


No IMT changes were observed between the tofogliflozin and the conventional treatment groups. However, tofogliflozin is a safe and effective treatment option for managing primary CVD risk factors in this population. Clinical Trial Registration UMIN000017607 ( https://www.umin.ac.jp/icdr/index.html ).",2020,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","['340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units', 'type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT', 'patients with type 2 diabetes']","['tofogliflozin', 'Tofogliflozin', 'tofogliflozin treatment group (n\u2009=\u2009169) or conventional treatment group using drugs other than SGLT2 inhibitors', 'tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor']","['carotid atherosclerosis', 'changes in mean and maximum common carotid IMT', 'HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C', 'progression of the mean-IMT-CCA', 'mean IMT of the common carotid artery', 'left max-IMT-CCA', 'IMT changes', 'total and serious adverse events incidences']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",340.0,0.0458559,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Mita', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yoshii', 'Affiliation': 'Department of Medicine, Diabetology & Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shiraiwa', 'Affiliation': 'Shiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara City, Osaka, 582-0005, Japan.'}, {'ForeName': 'Tetsuyuki', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka Police Hospital, 10-31, Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Umayahara', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Nakakinen Clinic, 745-5, Nakadai, Naka City, Ibaraki, 311-0113, Japan.'}, {'ForeName': 'Tsunehiko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Diabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki City, Hyogo, Japan.'}, {'ForeName': 'Nobuichi', 'Initials': 'N', 'LastName': 'Kuribayashi', 'Affiliation': 'Misaki Naika Clinic, 6-44-9, Futawa-higashi, Funabashi City, Chiba, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Kitasenri Maeda Clinic, 4-119 Furuedai, Suita, Osaka, 565-0874, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Jiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kosugi', 'Affiliation': 'Kosugi Medical Clinic, 3-9, Tamatsukurimoto-cho, Tennoji-ku, Osaka, 543-0014, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ohtoshi', 'Affiliation': 'Otoshi Medical Clinic, 8-47, Kakudacho, Osaka Kita-ku, Osaka, 530-0017, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Clinic, 3-9-23 Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sumitani', 'Affiliation': 'Center for Diabetes and Endocrinology, Nippon Life Hospital, 2-1-54 Enokojima, Nishi-ku, Osaka, 550-0006, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Tsugawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Ryomoto', 'Affiliation': 'Center for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Taki', 'Affiliation': 'Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Kobe Hyogo-ku, Hyogo, 652-0042, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Kanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01079-4']
2295,32646501,The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial.,"BACKGROUND


Rubus coreanus (R. coreanus) possesses properties that may decrease cholesterol levels.
METHODS


The effects of unripe R. coreanus (uRC) consumption on low-density lipoprotein (LDL) and total cholesterol levels related to decreased circulating apolipoprotein (Apo) B and oxidized LDL levels were evaluated. This randomized, double-blind, placebo-controlled study included subjects with borderline-high cholesterol levels (between 200 and 239 mg/dL) who consumed one capsule daily containing 600 mg of freeze-dried uRC extract (n = 39) or the placebo (n = 38).
RESULTS


After 12 weeks, the uRC group showed reductions of 21.23 ± 4.36 mg/dL in total cholesterol levels (P = 0.007) and 15.61 ± 4.16 mg/dL in LDL cholesterol levels (P = 0.032). In addition, significantly greater reductions in Apo B levels were observed in the uRC group (- 3.48 ± 3.40 mg/dL), but Apo B levels were increased in the placebo group (6.21 ± 2.84 mg/dL; P = 0.032). Furthermore, a remarkably lower oxidized LDL level was detected in the uRC group (57.76 ± 2.07 U/L) than in the placebo group (66.09 ± 3.47 U/L) after 12 weeks of consumption (P = 0.044).
CONCLUSIONS


Because of its cholesterol-lowering effect, uRC shows great promise as a therapeutic agent for subjects with borderline-high total blood cholesterol levels.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03649620 (8/28/2018, retrospectively registered).",2020,"After 12 weeks, the uRC group showed reductions of 21.23 ± 4.36 mg/dL in total cholesterol levels (P = 0.007) and 15.61 ± 4.16 mg/dL in LDL cholesterol levels (P = 0.032).","['n\u2009=\u200939) or the', 'subjects with borderline-high total blood cholesterol levels', 'n\u2009=\u200938', 'subjects with borderline-high cholesterol levels (between 200 and 239\u2009mg/dL) who', 'subjects with borderline-high cholesterol levels']","['unripe R. coreanus (uRC) consumption', 'consumed one capsule daily containing 600\u2009mg of freeze-dried uRC extract', 'placebo']","['oxidized LDL and apolipoprotein B levels', 'low-density lipoprotein (LDL) and total cholesterol levels', 'Apo B levels', 'total cholesterol levels', 'oxidized LDL level', 'circulating apolipoprotein (Apo) B and oxidized LDL levels', 'LDL cholesterol levels']","[{'cui': 'C2711208', 'cui_str': 'Borderline high'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",,0.339507,"After 12 weeks, the uRC group showed reductions of 21.23 ± 4.36 mg/dL in total cholesterol levels (P = 0.007) and 15.61 ± 4.16 mg/dL in LDL cholesterol levels (P = 0.032).","[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Cho', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Jisuk', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Sa Rang', 'Initials': 'SR', 'LastName': 'Jeong', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Moon', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Ki-Chan', 'Initials': 'KC', 'LastName': 'Ha', 'Affiliation': 'Healthcare Claims & Management Incorporation, Jeonju, Republic of Korea.'}, {'ForeName': 'Sunoh', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'B&Tech Co., Ltd., R&D Center, Gwangju, 61239, South Korea. sunoh@korea.ac.kr.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea. jhleeb@yonsei.ac.kr.'}]",Lipids in health and disease,['10.1186/s12944-020-01338-z']
2296,32654917,Left Ventricular Pressure-Strain Loop-Based Quantitative Examination of the Global and Regional Myocardial Work of Patients with Dilated Cardiomyopathy.,"The aim of our prospective pilot study was to explore the distribution characteristics of myocardial work (MW) of patients with dilated cardiomyopathy (DCM) and their clinical value in evaluation of therapeutic effects. Thirty patients with DCM were enrolled in the case group, and 30 healthy patients were randomly allocated to the control group. Global myocardial work (GMW) and regional myocardial work (RMW) of the control and case groups before and after therapy were evaluated by using left ventricular pressure-strain loops and then compared. We found significant differences in GMW and RMW between the control and case groups (p < 0.05). Compared with before therapy, the global work index and 6-min walking distance increased, but LV ejection fraction and global longitudinal strain did not significantly change after therapy. GMW was significantly correlated with LV ejection fraction and global longitudinal strain (p < 0.01). Bland-Altman plot analysis revealed that GMW values were consistent between and within the groups. The results suggest that LV MW values were diffusely impaired in patients with DCM and that the global work index may be used as an indicator in evaluation of therapeutic effects.",2020,We found significant differences in GMW and RMW between the control and case groups (p < 0.05).,"['Thirty patients with DCM were enrolled in the case group, and 30 healthy patients', 'Patients with Dilated Cardiomyopathy', 'patients with dilated cardiomyopathy (DCM', 'patients with DCM']",[],"['GMW', 'LV ejection fraction and global longitudinal strain', 'global work index and 6-min walking distance increased, but LV ejection fraction and global longitudinal strain', 'GMW values', 'GMW and RMW', 'LV MW values', 'Global myocardial work (GMW) and regional myocardial work (RMW']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007193', 'cui_str': 'Dilated cardiomyopathy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",30.0,0.021088,We found significant differences in GMW and RMW between the control and case groups (p < 0.05).,"[{'ForeName': 'Cunying', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Danqing', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Lianzhong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China. Electronic address: lianzhong_z@126.com.""}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2020.06.008']
2297,32655007,Metabolomics Analysis of Aspirin's Effects in Human Colon Tissue and Associations with Adenoma Risk.,"Although substantial evidence supports aspirin's efficacy in colorectal cancer chemoprevention, key molecular mechanisms are uncertain. An untargeted metabolomics approach with high-resolution mass spectrometry was used to elucidate metabolic effects of aspirin treatment in human colon tissue. We measured 10,269 metabolic features in normal mucosal biopsies collected at colonoscopy after approximately three years of randomized treatment with placebo, 81 mg/day or 325 mg/day aspirin from 325 participants in the Aspirin/Folate Polyp Prevention Study. Linear regression was used to identify aspirin-associated metabolic features and network analysis was used to identify pathways and predict metabolite identities. Poisson regression was used to examine metabolic features associations with colorectal adenoma risk. We detected 471 aspirin-associated metabolic features. Aside from the carnitine shuttle, aspirin-associated metabolic pathways were largely distinct for 81 mg aspirin (e.g., pyrimidine metabolism) and 325 mg (e.g., arachidonic acid metabolism). Among aspirin-associated metabolic features, we discovered three that were associated with adenoma risk and could contribute to the chemopreventive effect of aspirin treatment, and which have also previously been associated with colorectal cancer: creatinine, glycerol 3-phosphate and linoleate. The last two of these are in the glycerophospholipid metabolism pathway, which was associated with 81 mg aspirin treatment and provides precursors for the synthesis of eicosanoids from arachidonic acid upstream of cyclooxygenase inhibition by aspirin. Conversely, carnitine shuttle metabolites were increased with aspirin treatment and associated with increased adenoma risk. Thus, our untargeted metabolomics approach has identified novel metabolites and pathways that may underlie the effects of aspirin during early colorectal carcinogenesis.",2020,"Aside from the carnitine shuttle, aspirin-associated metabolic pathways were largely distinct for 81 mg aspirin (e.g., pyrimidine metabolism) and 325 mg (e.g., arachidonic acid metabolism).","['human colon tissue', 'Human Colon Tissue and Associations with Adenoma Risk']","['placebo, 81 mg/day or 325 mg/day aspirin', 'Aspirin', 'aspirin']","['adenoma risk', 'carnitine shuttle metabolites']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",10269.0,0.0361142,"Aside from the carnitine shuttle, aspirin-associated metabolic pathways were largely distinct for 81 mg aspirin (e.g., pyrimidine metabolism) and 325 mg (e.g., arachidonic acid metabolism).","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College Elizabeth.L.R.Barry@dartmouth.edu.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Fedirko', 'Affiliation': 'Department of Epidemiology, Emory University, Rollins School of Public Health.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Uppal', 'Affiliation': 'Emory University.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Emory University.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Emory University.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': 'Epidemiology, Dartmouth College.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Passarelli', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Dean P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Emory University.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0014']
2298,32655024,"The Effects of Nano-curcumin on Metabolic Status in Patients With Diabetes on Hemodialysis, a Randomized, Double Blind, Placebo-controlled Trial.","INTRODUCTION


This study evaluated the effects of nano-curcumin intake on metabolic status in patients with diabetes on hemodialysis (HD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was performed on 60 patients with diabetes on HD. Participants were randomly divided into two groups to take either 80 mg/d nano-curcumin (n = 30) or placebo (n = 30) for 12 weeks.
RESULTS


Nano-curcumin significantly decreased fasting plasma glucose (β = -19.68 mg/dL, 95% CI: -33.48 to -5.88; P < .05) and serum insulin levels (β = -1.70 μIU/mL, 95% CI: -2.96 to -0.44; P < .05) when compared with patients who received placebo. Nanocurcumin treatment was associated with a significant reduction in triglycerides (β = -16.13 mg/dL, 95% CI: -31.51 to -0.75; P < .05), VLDL-cholesterol (β = -3.22 mg/dL, 95% CI: -6.30 to -0.15; P < .05), total cholesterol (β = -17.83 mg/dL, 95% CI: -29.22 to -6.45; P < .05), LDL-cholesterol (β = -15.20 mg/dL, 95% CI: -25.53 to -4.87; P < .05), and total-cholesterol/HDL-cholesterol ratio (β = -1.15, 95% CI: -0.2.10 to -0.21; P < .05) when compared with the placebo. Nanocurcumin also resulted in a significant reduction of serum high sensitivity CRP (β = -0.78 mg/L, 95% CI: -1.41 to -0.15; P < .05), and plasma malondialdehyde (β = -0.25 μmol/L, 95% CI: -0.45 to -0.04; P < .05); but also with a significant increase in plasma total antioxidant capacity (β = 52.43 mmol/L; 95% CI: 4.52 to 100.35; P < .05) and total nitrite levels (β = 3.62 μmol/L, 95% CI: 2.17 to 5.08; P < .001) when compared with placebo.
CONCLUSION


Nano-curcumin intake for 12 weeks had beneficial effects on metabolic profile in patients with diabetes on HD.",2020,"RESULTS


Nano-curcumin significantly decreased fasting plasma glucose (β = -19.68 mg/dL, 95% CI: -33.48 to -5.88; P < .05) and serum insulin levels (β = -1.70 μIU/mL, 95% CI: -2.96 to -0.44; P","['patients with diabetes on HD', '60 patients with diabetes on HD', 'Patients With Diabetes on Hemodialysis', 'patients with diabetes on hemodialysis (HD']","['80 mg/d nano-curcumin', 'Placebo', 'Nanocurcumin', 'Nano-curcumin', 'Nano-curcumin intake', 'nano-curcumin intake', 'placebo']","['plasma total antioxidant capacity', 'triglycerides ', 'total nitrite levels', 'total cholesterol', 'metabolic status', 'VLDL-cholesterol', 'Metabolic Status', 'total-cholesterol/HDL-cholesterol ratio', 'plasma malondialdehyde', 'LDL-cholesterol', 'serum high sensitivity CRP', 'metabolic profile', 'serum insulin levels', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0580333', 'cui_str': 'Urine nitrite'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",60.0,0.295549,"RESULTS


Nano-curcumin significantly decreased fasting plasma glucose (β = -19.68 mg/dL, 95% CI: -33.48 to -5.88; P < .05) and serum insulin levels (β = -1.70 μIU/mL, 95% CI: -2.96 to -0.44; P","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Reiner', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': ''}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': ''}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. r.shafabakhsh@gmail.com.'}]",Iranian journal of kidney diseases,[]
2299,32655047,Effects of dietary counseling on sodium restriction in patients with chronic kidney disease on hemodialysis: A randomized clinical trial.,"Reducing dietary sodium has the potential to benefit patients with chronic kidney disease on hemodialysis (HD). This study was aimed to evaluate the effects of dietary counseling on sodium restriction and its relationship with clinical, dietary, and quality of life parameters in patients on HD treatment. This study was designed as a randomized clinical trial. The study included 87 patients on HD, divided into intervention (n = 47) and control (n = 40) groups. Anthropometric, clinical, sodium intake, and quality of life data were evaluated in both groups at four-time points: baseline (T0), 90 days (T3), 180 days (T6), and 365 days (T12). The intervention group received dietary counseling at the beginning and throughout the study. There were no between-group differences regarding anthropometric, clinical, and quality of life data at any of the time points. The mean age was 59 ± 14 years, and most of the patients were men (61%) and had hypertension (90%). Total sodium (g) and processed meat (mg sodium) intake significantly decreased in both groups [intervention: T0 = 3.5 (2.3-4.7); T12 = 2.0 (0.7-2.5); P <0.0001; control: T0 = 3 (1.5-4.9); T12 = 2.0 (0.8-3.3); P = 0.001; and intervention: T0 = 78 (25-196); T12 = 21 (0-78); P = 0.003; control: T0 = 97 (31-406); T12 = 44 (0-152); P = 0.004, respectively] . There was a significant decrease in the consumption of packaged seasonings (mg sodium) [T0 = 130 (0-854); T12 = 0 (0-0); P = 0.015] and instant noodles [T0 = 19 (0-91); T12 = 0 (0-0); P = 0.017] in the intervention group. Dietary counseling was effective in changing dietary habits. In both groups, there was a reduction in total sodium intake, which was greater in the intervention group. Moreover, a decrease in the intake of salty foods, such as packaged seasonings and instant noodles, was only observed in the intervention group.",2020,"There were no between-group differences regarding anthropometric, clinical, and quality of life data at any of the time points.","['patients with chronic kidney disease on hemodialysis', 'The mean age was 59 ± 14 years, and most of the patients were men (61%) and had hypertension (90', 'patients with chronic kidney disease on hemodialysis (HD', 'patients on HD treatment', '87 patients on HD, divided into intervention (n = 47) and control (n = 40) groups']","['Dietary counseling', 'dietary counseling', 'dietary sodium']","['intake of salty foods, such as packaged seasonings and instant noodles', 'consumption of packaged seasonings', 'sodium restriction and its relationship with clinical, dietary, and quality of life parameters', 'Total sodium (g) and processed meat (mg sodium) intake', 'total sodium intake', 'anthropometric, clinical, and quality of life data', 'Anthropometric, clinical, sodium intake, and quality of life data']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453862', 'cui_str': 'Salty food'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0452689', 'cui_str': 'Noodles'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",87.0,0.0179583,"There were no between-group differences regarding anthropometric, clinical, and quality of life data at any of the time points.","[{'ForeName': 'Amanda Brito', 'Initials': 'AB', 'LastName': 'de Freitas', 'Affiliation': 'Nutrition Graduate Course, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna Bellincanta', 'Initials': 'BB', 'LastName': 'Nicoletto', 'Affiliation': 'Knowledge Areaof Life Sciences, Universidade de Caxias do Sul, Caxias do Sul, Brazil.'}, {'ForeName': 'Karina Sanches', 'Initials': 'KS', 'LastName': ""Machado d'Almeida"", 'Affiliation': 'Nutrition Graduate Course, Universidade Federal do Pampa, Itaqui, Brazil.'}, {'ForeName': 'Nícia Maria', 'Initials': 'NM', 'LastName': 'Romano de Medeiros Bastos', 'Affiliation': 'Division of Nephrology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Roberto Ceratti', 'Initials': 'RC', 'LastName': 'Manfro', 'Affiliation': 'Division of Nephrology, Hospital de Clínicas de Porto Alegre; Department of Internal Medicine, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil,, Brazil.'}, {'ForeName': 'Gabriela Corrêa', 'Initials': 'GC', 'LastName': 'Souza', 'Affiliation': 'Department of Nutrition, School of Medicine, Universidade Federal do Rio Grande do Sul; Food and Nutrition Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}]","Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia",['10.4103/1319-2442.289447']
2300,32655386,Modulation of Intrinsic Brain Connectivity by Implicit Electroencephalographic Neurofeedback.,"Despite the increasing popularity of neurofeedback, its mechanisms of action are still poorly understood. This study aims to describe the processes underlying implicit electroencephalographic neurofeedback. Fifty-two healthy volunteers were randomly assigned to a single session of infra-low frequency neurofeedback or sham neurofeedback, with electrodes over the right middle temporal gyrus and the right inferior parietal lobule. They observed a moving rocket, the speed of which was modulated by the waveform derived from a band-limited infra-low frequency filter. Immediately before and after the session, the participants underwent a resting-state fMRI. Network-based statistical analysis was applied, comparing post- vs. pre-session and real vs. sham neurofeedback conditions. As a result, two phenomena were observed. First, we described a brain circuit related to the implicit neurofeedback process itself, consisting of the lateral occipital cortex, right dorsolateral prefrontal cortex, left orbitofrontal cortex, right ventral striatum, and bilateral dorsal striatum. Second, we found increased connectivity between key regions of the salience, language, and visual networks, which is indicative of integration in sensory processing. Thus, it appears that a single session of implicit infra-low frequency electroencephalographic neurofeedback leads to significant changes in intrinsic brain connectivity.",2020,"Fifty-two healthy volunteers were randomly assigned to a single session of infra-low frequency neurofeedback or sham neurofeedback, with electrodes over the right middle temporal gyrus and the right inferior parietal lobule.",['Fifty-two healthy volunteers'],"['single session of infra-low frequency neurofeedback or sham neurofeedback, with electrodes over the right middle temporal gyrus and the right inferior parietal lobule']","['connectivity between key regions of the salience, language, and visual networks']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",52.0,0.0221664,"Fifty-two healthy volunteers were randomly assigned to a single session of infra-low frequency neurofeedback or sham neurofeedback, with electrodes over the right middle temporal gyrus and the right inferior parietal lobule.","[{'ForeName': 'Olga R', 'Initials': 'OR', 'LastName': 'Dobrushina', 'Affiliation': 'Third Neurological Department, Research Center of Neurology, Moscow, Russia.'}, {'ForeName': 'Roza M', 'Initials': 'RM', 'LastName': 'Vlasova', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC, United States.'}, {'ForeName': 'Alena D', 'Initials': 'AD', 'LastName': 'Rumshiskaya', 'Affiliation': 'Davydovsky Public Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Liudmila D', 'Initials': 'LD', 'LastName': 'Litvinova', 'Affiliation': 'Radiology Department, Federal Center of Treatment and Rehabilitation, Moscow, Russia.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Mershina', 'Affiliation': 'Medical Research and Educational Center, Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'Valentin E', 'Initials': 'VE', 'LastName': 'Sinitsyn', 'Affiliation': 'Medical Research and Educational Center, Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'Ekaterina V', 'Initials': 'EV', 'LastName': 'Pechenkova', 'Affiliation': 'Laboratory for Cognitive Research, National Research University Higher School of Economics, Moscow, Russia.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00192']
2301,32655387,Effect of tDCS Over the Right Inferior Parietal Lobule on Mind-Wandering Propensity.,"Mind-wandering is associated with switching our attention to internally directed thoughts and is by definition an intrinsic, self-generated cognitive function. Interestingly, previous research showed that it may be possible to modulate its propensity externally, with transcranial direct current stimulation (tDCS) targeting different regions in the default mode and executive control networks (ECNs). However, these studies used highly heterogeneous montages (targeting the dorsolateral prefrontal cortex (DLPFC), the right inferior parietal lobule (IPL), or both concurrently), often showed contradicting results, and in many cases failed to replicate. Our study aimed to establish whether tDCS of the default mode network (DMN),  via  targeting the right IPL alone, could modulate mind-wandering propensity using a within-subjects double-blind, counterbalanced design. Participants completed sustained attention to response task (SART) interspersed with thought-probes to capture their subjective reports of mind-wandering before and after receiving anodal, cathodal, or sham tDCS over the right IPL (with the reference over the left cheek). We found evidence for the lack of an effect of stimulation on subjective reports of mind-wandering (JZS-BF 01  = 5.19), as well as on performance on the SART task (errors (JZS-BF 01  = 6.79) and reaction time (JZS-BF 01  = 5.94). Overall, we failed to replicate previous reports of successful modulations of mind-wandering propensity with tDCS over the IPL, instead of providing evidence in support of the lack of an effect. This and other recent unsuccessful replications call into question whether it is indeed possible to externally modulate spontaneous or self-generated cognitive processes.",2020,"Overall, we failed to replicate previous reports of successful modulations of mind-wandering propensity with tDCS over the IPL, instead of providing evidence in support of the lack of an effect.",[],['tDCS'],"['sustained attention to response task (SART', 'reaction time']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0599957,"Overall, we failed to replicate previous reports of successful modulations of mind-wandering propensity with tDCS over the IPL, instead of providing evidence in support of the lack of an effect.","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Coulborn', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Bowman', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'R Chris', 'Initials': 'RC', 'LastName': 'Miall', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Davinia', 'Initials': 'D', 'LastName': 'Fernández-Espejo', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00230']
2302,32655403,Resistance Exercise in a Hot Environment Alters Serum Markers in Untrained Males.,"Purpose:  We examined the effects of moderate resistance exercise (RE) on serum cortisol, testosterone, extracellular heat shock protein (HSP70), and interleukin (IL)-6 and IL-15 concentrations in untrained males in a hot environment.  Methods:  Ten untrained young males (26 ± 3 years; 75.8 ± 6 kg; 177.4 ± 5.3 cm) performed two series of full body RE [3 sets of 8 to 10 repetitions, 30-60 s recovery between series with 70% of one maximal repetition (1-RM), with a rest period of 1 to 3 min between exercises] carried out in a random order in both heated (∼35°C) and thermoneutral (22°C) conditions. Serum concentrations of testosterone, cortisol, HSP70, and IL-6 and IL-15 were measured before, at the end, and 1 h after RE sessions. Participants in both groups consumed 4 ml of water/kg body mass every 15 min.  Results:  There were time-related changes in testosterone, HSP70, and IL-6 ( P  < 0.001), and cortisol and IL-15 ( P  < 0.05). Levels of cortisol, HSP70, and IL-6 increased immediately for RE at 35°C, and testosterone and IL-15 levels were decreased. Changes in serum testosterone, HSP70, cortisol, and IL-15 and IL-6 levels were reversed after 1 h. A significant time × condition interaction was observed for IL-15 and HSP70 ( P  < 0.001), cortisol and IL-6 ( P  < 0.05), but not for testosterone ( P  > 0.05).  Conclusion:  RE in a heated environment may not be appropriate for achieving muscle adaptations due to acute changes of hormonal and inflammatory markers.",2020,"A significant time × condition interaction was observed for IL-15 and HSP70 ( P  < 0.001), cortisol and IL-6 ( P  < 0.05), but not for testosterone ( P  > 0.05).  ","['untrained males in a hot environment', 'Ten untrained young males (26 ± 3 years; 75.8 ± 6 kg; 177.4 ± 5.3 cm', 'Untrained Males']","['moderate resistance exercise (RE', 'maximal repetition (1-RM), with a rest period of 1 to 3 min between exercises', 'Resistance Exercise']","['serum testosterone, HSP70, cortisol, and IL-15 and IL-6 levels', 'Serum concentrations of testosterone, cortisol, HSP70, and IL-6 and IL-15', 'serum cortisol, testosterone, extracellular heat shock protein (HSP70), and interleukin (IL)-6 and IL-15 concentrations', 'Levels of cortisol, HSP70, and IL-6 increased immediately for RE at 35°C, and testosterone and IL-15 levels', 'cortisol and IL-15', 'cortisol and IL-6', 'time-related changes in testosterone, HSP70, and IL-6', 'IL-15 and HSP70']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0241922', 'cui_str': 'Hot environment'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708663', 'cui_str': '5.3'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",10.0,0.0358044,"A significant time × condition interaction was observed for IL-15 and HSP70 ( P  < 0.001), cortisol and IL-6 ( P  < 0.05), but not for testosterone ( P  > 0.05).  ","[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Tehran University, Tehran, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Fashi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Health Sciences, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Saeidi', 'Affiliation': 'Department of Physical Education, Damghan Branch, Islamic Azad University, Damghan, Iran.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Boullosa', 'Affiliation': 'INISA, Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Laher', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Abderraouf', 'Initials': 'A', 'LastName': 'Ben Abderrahman', 'Affiliation': 'ISSEP Ksar Said, University of Manouba, Tunis, Tunisia.'}, {'ForeName': 'Gerorges', 'Initials': 'G', 'LastName': 'Jabbour', 'Affiliation': 'University of Qatar, Doha, Qatar.'}, {'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Zouhal', 'Affiliation': 'Université de Rennes, M2S (Laboratoire Mouvement, Sport, Santé) - EA 1274, Rennes, France.'}]",Frontiers in physiology,['10.3389/fphys.2020.00597']
2303,32655423,The Effect of Ketamine on Electrophysiological Connectivity in Major Depressive Disorder.,"Major depressive disorder (MDD) is highly prevalent and frequently disabling. Only about 30% of patients respond to a first-line antidepressant treatment, and around 30% of patients are classified as ""treatment-resistant"" after failing to respond to multiple adequate trials. While most antidepressants target monoaminergic targets, ketamine is an N-methyl-D-aspartate (NMDA) antagonist that has shown rapid antidepressant effects when delivered intravenously or intranasally. While there is evidence that ketamine exerts its effects  via  enhanced α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) throughput, its mechanism for relieving depressive symptoms is largely unknown. This study acquired resting-state magnetoencephalography (MEG) recordings after both ketamine and placebo infusions and investigated functional connectivity using a multilayer amplitude-amplitude correlation technique spanning the canonical frequency bands. Twenty-four healthy volunteers (HVs) and 27 unmedicated participants with MDD took part in a double-blind, placebo-controlled, crossover trial of 0.5 mg/kg IV ketamine. Order of infusion was randomized, and participants crossed over to receive the second infusion after two weeks. The results indicated widespread ketamine-induced reductions in connectivity in the alpha and beta bands that did not correlate with magnitude of antidepressant response. In contrast, the magnitude of ketamine's antidepressant effects in MDD participants was associated with cross-frequency connectivity for delta-alpha and delta-gamma bands, with HVs and ketamine non-responders showing connectivity decreases post-ketamine and ketamine responders demonstrating small increases in connectivity. These results may indicate functional subtypes of MDD and also suggest that neural responses to ketamine are fundamentally different between responders and non-responders.",2020,The results indicated widespread ketamine-induced reductions in connectivity in the alpha and beta bands that did not correlate with magnitude of antidepressant response.,"['Major Depressive Disorder', 'Twenty-four healthy volunteers (HVs) and 27 unmedicated participants with MDD took part in a double-blind']","['ketamine', 'Ketamine', 'ketamine and placebo', 'placebo']",['connectivity'],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],24.0,0.141166,The results indicated widespread ketamine-induced reductions in connectivity in the alpha and beta bands that did not correlate with magnitude of antidepressant response.,"[{'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'MEG Core Facility, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Ballard', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Prejaas K', 'Initials': 'PK', 'LastName': 'Tewarie', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Brookes', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00519']
2304,32655426,Embedding Scientific Explanations Into Storybooks Impacts Children's Scientific Discourse and Learning.,"Children's understanding of unobservable scientific entities largely depends on testimony from others, especially through parental explanations that highlight the mechanism underlying a scientific entity. Mechanistic explanations are particularly helpful in promoting children's conceptual understanding, yet they are relatively rare in parent-child conversations. The current study aimed to increase parent-child use of mechanistic conversation by modeling this language in a storybook about the mechanism of electrical circuits. We also examined whether an increase in mechanistic conversation was associated with science learning outcomes, measured at both the dyadic- and child-level. In the current study, parents and their 4- to 5-year-old children ( N  = 60) were randomly assigned to read a book containing mechanistic explanations ( n  = 32) or one containing non-mechanistic explanations ( n  = 28). After reading the book together, parent-child joint understanding of electricity's mechanism was tested by asking the dyad to assemble electrical components of a circuit toy so that a light would turn on. Finally, child science learning outcomes were examined by asking children to assemble a novel circuit toy and answer comprehension questions to gauge their understanding of electricity's mechanism. Results indicate that dyads who read storybooks containing mechanistic explanations were (1) more successful at completing the circuit (putting the pieces together to make the light turn on) and (2) used more mechanistic language than dyads assigned to the non-mechanistic condition. Children in the mechanistic condition also had better learning outcomes, but only if they engaged in more mechanistic discourse with their parent. We discuss these results using a social interactionist framework to highlight the role of input and interaction for learning. We also highlight how these results implicate everyday routines such as book reading in supporting children's scientific discourse and understanding.",2020,"Children in the mechanistic condition also had better learning outcomes, but only if they engaged in more mechanistic discourse with their parent.",['parents and their 4- to 5-year-old children ( N  = 60'],['read a book containing mechanistic explanations ( n  = 32) or one containing non-mechanistic explanations'],['mechanistic conversation'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]",[],60.0,0.014023,"Children in the mechanistic condition also had better learning outcomes, but only if they engaged in more mechanistic discourse with their parent.","[{'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Leech', 'Affiliation': 'School of Education, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Haber', 'Affiliation': 'Wheelock College of Education and Applied Human Development, Boston University, Boston, MA, United States.'}, {'ForeName': 'Youmna', 'Initials': 'Y', 'LastName': 'Jalkh', 'Affiliation': 'Wheelock College of Education and Applied Human Development, Boston University, Boston, MA, United States.'}, {'ForeName': 'Kathleen H', 'Initials': 'KH', 'LastName': 'Corriveau', 'Affiliation': 'Wheelock College of Education and Applied Human Development, Boston University, Boston, MA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01016']
2305,32655429,"Do Counter-Narratives Reduce Support for ISIS? Yes, but Not for Their Target Audience.","The purpose of this research is to experimentally test whether counter-narratives are effective to reduce people's support and willingness to join Islamic State of Iraq and Syria (ISIS). Integrating psychological reactance theory (Brehm, 1966) and need for closure (NFC; Kruglanski, 2004), we predicted that exposing people to counter-narratives when they are at greater risk of radicalization (high NFC individuals) would be counterproductive and enhance their support for ISIS. Participants ( N  = 886 American Muslims) were randomly assigned to a 3 × 3 factorial experimental design varying the source (United States Government, Imam, ISIS defector), and the content (social, political, and religious) of the counter-narrative while comparing these groups to a control message. Results show an overall small positive effect of counter-narratives (β = -0.107,  p  = 0.043), but also evidence for greater support for ISIS in individuals at greater risk of radicalization (β = 0.154,  p  = 0.005). Results also show that the content was more important than the source: A political narrative was the most effective, and this result is consistent across different sources although an ISIS defector is the most effective messenger. These findings challenge the widespread assumption that counter-narratives are effective against violent extremism. In fact, they accelerate the very phenomenon that governments and policy makers are trying to undermine. Therefore, policy makers should avoid including them in their armamentarium to tackle violent extremism.",2020,"Results also show that the content was more important than the source: A political narrative was the most effective, and this result is consistent across different sources although an ISIS defector is the most effective messenger.",['Participants ( N  = 886 American Muslims'],[],['overall small positive effect of counter-narratives'],"[{'cui': 'C0022126', 'cui_str': 'Islam'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C1135957', 'cui_str': 'Narration'}]",,0.0247557,"Results also show that the content was more important than the source: A political narrative was the most effective, and this result is consistent across different sources although an ISIS defector is the most effective messenger.","[{'ForeName': 'Jocelyn J', 'Initials': 'JJ', 'LastName': 'Bélanger', 'Affiliation': 'Department of Psychology, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Claudia F', 'Initials': 'CF', 'LastName': 'Nisa', 'Affiliation': 'Department of Psychology, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Birga M', 'Initials': 'BM', 'LastName': 'Schumpe', 'Affiliation': 'Department of Psychology, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Tsion', 'Initials': 'T', 'LastName': 'Gurmu', 'Affiliation': 'Department of Psychology, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Williams', 'Affiliation': 'Department of Psychology, American University in the Emirates, Dubai, United Arab Emirates.'}, {'ForeName': 'Idhamsyah Eka', 'Initials': 'IE', 'LastName': 'Putra', 'Affiliation': 'Department of Psychology, Persada Indonesia University, Jakarta, Indonesia.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01059']
2306,32655753,Effects of counseling professional ethics principles on midwifery professional codes of ethics compliance and applicability rate among midwives in community health centers: a randomized clinical trial in Iran.,"Introduction


Compliance with ethical principles is regarded as one of the key components in providing services in midwifery profession. This study was to evaluate the effects of counseling professional ethics principles on midwifery professional codes of ethics compliance and applicability rate among midwives working in community health centers in the city of Karaj, Iran.
Methods


This randomized controlled trial (RCT) was conducted in 2018 on a total number of 84 eligible midwives in two intervention and control groups, selected through multistage sampling method. The intervention group took part in six counseling sessions but the control group only received a training manual. Both groups then completed the Self-Reporting Questionnaire of Ethical Codes of Reproductive Health Providers (including 95 items in 14 domains) at three time points (before, immediately, and four weeks after intervention). Finally, the data were analyzed using the IBM SPSS Statistics (version 22) software via descriptive and inferential statistics.
Results


The findings showed that level of compliance and applicability rate in all 14 domains of midwifery professional codes of ethics were higher in the intervention group (after intervention) than those in the control group and trend of time changes in mean level of compliance and applicability rate of codes of ethics during the three time points were significantly different between both groups (p < 0.001).
Conclusion


Given the effectiveness of counseling professional ethics principles on midwifery professional codes of ethics compliance and applicability rate among the midwives working in community health centers, designing and applying this counseling approach was recommended to improve quality of reproductive health care services.",2020,"The findings showed that level of compliance and applicability rate in all 14 domains of midwifery professional codes of ethics were higher in the intervention group (after intervention) than those in the control group and trend of time changes in mean level of compliance and applicability rate of codes of ethics during the three time points were significantly different between both groups (p < 0.001).
","['midwives in community health centers', '2018 on a total number of 84 eligible midwives in two intervention and control groups, selected through multistage sampling method', 'midwives working in community health centers', 'midwives working in community health centers in the city of Karaj, Iran']","['counseling professional ethics principles', 'intervention group took part in six counseling sessions but the control group only received a training manual']","['IBM SPSS Statistics', 'level of compliance and applicability rate', 'mean level of compliance and applicability rate of codes of ethics']","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0015007', 'cui_str': 'Professional Ethics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1135938', 'cui_str': 'Code of Ethics'}]",,0.0369561,"The findings showed that level of compliance and applicability rate in all 14 domains of midwifery professional codes of ethics were higher in the intervention group (after intervention) than those in the control group and trend of time changes in mean level of compliance and applicability rate of codes of ethics during the three time points were significantly different between both groups (p < 0.001).
","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Shahabnia', 'Affiliation': 'Student in Midwifery Counseling, Student Research Committee, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Lotfi', 'Affiliation': 'Midwifery and Reproductive Health Department, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rahimzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Yazdkhasti', 'Affiliation': 'Midwifery and Reproductive Health Department, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Zahra Mehdizadeh', 'Initials': 'ZM', 'LastName': 'Tourzani', 'Affiliation': 'Midwifery and Reproductive Health Department, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}]",The Pan African medical journal,['10.11604/pamj.2020.35.139.20702']
2307,32655854,"The effects of intramuscular administration of scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled trial.","Introduction


Major depressive disorder (MDD) is a common affective disorder. Currently established pharmacotherapies lack rapid clinical response, thereby limiting their ability to bring instant relief to patients. A series of clinical trials has demonstrated the antidepressant effects of scopolamine, yet few have studied the effects of add-on scopolamine to currently available antidepressants. It is not known whether conventional antidepressant treatment with a 3-day scopolamine injection could speed up oral antidepressant efficacy. The main focus of this study is to detect the capacity of the rapid-onset efficacy of such a treatment option.
Methods and analysis


This study consisted of a single-centre, double-blind, three-arm randomized trial with a 4-week follow-up period. Sixty-six participants meeting entry criteria were randomly allocated to three treatment groups: a high-dose group, a low-dose group and a placebo control group. Psychiatric rating scales were administered at baseline and seven viewing points following the administration of intramuscular injections. The primary outcome measure was length of time from randomization (baseline) to early improvement.
Results


Both primary and secondary outcome measures consistently showed no differences among the three groups. The cumulative response rate and the remission rate were 72.7% (48/66) and 47.0% (31/66). Intramuscular scopolamine treatment was relatively well tolerated. Two subjects with high-dose injections dropped out because of a drug-related side effect.
Conclusion


Contrary to our prediction, we found that, compared to placebo (0.9% saline i.m.), scopolamine was not associated with a significantly faster antidepressant response rate.
Trial registration


ClinicalTrials.gov, NCT03131050. Registered on 18 April 2017.",2020,The cumulative response rate and the remission rate were 72.7% (48/66) and 47.0% (31/66).,"['moderate to severe major depressive disorder', 'Sixty-six participants meeting entry criteria']","['scopolamine injection', 'placebo control group', 'scopolamine augmentation', 'Intramuscular scopolamine', 'scopolamine', 'placebo']","['length of time from randomization (baseline) to early improvement', 'Psychiatric rating scales', 'tolerated', 'cumulative response rate and the remission rate']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",66.0,0.687425,The cumulative response rate and the remission rate were 72.7% (48/66) and 47.0% (31/66).,"[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuequan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Zghoul', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, 5 Ankang Lane, Dewai Avenue, Xicheng District, Beijing 100088, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, 5 Ankang Lane, Dewai Avenue, Xicheng District, Beijing 100088, China.'}]",Therapeutic advances in psychopharmacology,['10.1177/2045125320938556']
2308,32655950,Noninvasive Neurally Adjusted Ventilator Assist Ventilation in the Postoperative Period Produces Better Patient-Ventilator Synchrony but Not Comfort.,"Background


Noninvasive neurally adjusted ventilatory assist (NAVA) has been shown to improve patient-ventilator interaction in many settings. There is still scarce data with regard to postoperative patients indicated for noninvasive ventilation (NIV) which this study elates. The purpose of this trial was to evaluate postoperative patients for synchrony and comfort in noninvasive pressure support ventilation (NIV-PSV) vs. NIV-NAVA.
Methods


Twenty-two subjects received either NIV-NAVA or NIV-PSV in an object-blind, prospective, randomized, crossover fashion (observational trial). We evaluated blood gases and ventilator tracings throughout as well as comfort of ventilation at the end of each ventilation phase.
Results


There was an effective reduction in ventilator delays ( p  < 0.001) and negative pressure duration in NIV-NAVA as compared to NIV-PSV ( p  < 0.001). Although we used optimized settings in NIV-PSV, explaining the overall low incidence of asynchrony, NIV-NAVA led to reductions in the NeuroSync-index ( p  < 0.001) and all types of asynchrony except for double triggering that was significantly more frequent in NIV-NAVA vs. NIV-PSV ( p  = 0.02); ineffective efforts were reduced to zero by use of NIV-NAVA. In our population of previously lung-healthy subjects, we did not find differences in blood gases and patient comfort between the two modes.
Conclusion


In the postoperative setting, NIV-NAVA is well suitable for use and effective in reducing asynchronies as well as a surrogate for work of breathing. Although increased synchrony was not transferred into an increased comfort, there was an advantage with regard to patient-ventilator interaction. The trial was registered at the German clinical Trials Register (DRKS no.: DRKS00005408).",2020,There was an effective reduction in ventilator delays ( p  < 0.001) and negative pressure duration in NIV-NAVA as compared to NIV-PSV ( p  < 0.001).,[],"['\n\n\nNoninvasive neurally adjusted ventilatory assist (NAVA', 'NIV-NAVA or NIV-PSV', 'noninvasive pressure support ventilation (NIV-PSV) vs. NIV-NAVA', 'Noninvasive Neurally Adjusted Ventilator Assist Ventilation']","['blood gases and ventilator tracings', 'blood gases and patient comfort', 'negative pressure duration', 'ventilator delays']",[],"[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",22.0,0.131504,There was an effective reduction in ventilator delays ( p  < 0.001) and negative pressure duration in NIV-NAVA as compared to NIV-PSV ( p  < 0.001).,"[{'ForeName': 'L O', 'Initials': 'LO', 'LastName': 'Harnisch', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Göttingen, Germany Robert-Koch-Str. 40 D-37099 Göttingen.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Olgemoeller', 'Affiliation': 'Department of Cardiology and Pulmonology, University Medical Centre Göttingen, Robert-Koch-Str. 40 D-37099 Göttingen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Göttingen, Germany Robert-Koch-Str. 40 D-37099 Göttingen.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Quintel', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Göttingen, Germany Robert-Koch-Str. 40 D-37099 Göttingen.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Moerer', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Göttingen, Germany Robert-Koch-Str. 40 D-37099 Göttingen.'}]",Pulmonary medicine,['10.1155/2020/4705042']
2309,32655984,Soothing Your Heart and Feeling Connected: A New Experimental Paradigm to Study the Benefits of Self-Compassion.,"Self-compassion and its cultivation in psychological interventions are associated with improved mental health and well-being. However, the underlying processes for this are not well understood. We randomly assigned 135 participants to study the effect of two short-term self-compassion exercises on self-reported-state mood and psychophysiological responses compared to three control conditions of negative (rumination), neutral, and positive (excitement) valence. Increased self-reported-state self-compassion, affiliative affect, and decreased self-criticism were found after both self-compassion exercises and the positive-excitement condition. However, a psychophysiological response pattern of reduced arousal (reduced heart rate and skin conductance) and increased parasympathetic activation (increased heart rate variability) were unique to the self-compassion conditions. This pattern is associated with effective emotion regulation in times of adversity. As predicted, rumination triggered the opposite pattern across self-report and physiological responses. Furthermore, we found partial evidence that physiological arousal reduction and parasympathetic activation precede the experience of feeling safe and connected.",2019,"Increased self-reported-state self-compassion, affiliative affect, and decreased self-criticism were found after both self-compassion exercises and the positive-excitement condition.",[],"['short-term self-compassion exercises on self-reported-state mood and psychophysiological responses compared to three control conditions of negative (rumination), neutral, and positive (excitement) valence']","['Increased self-reported-state self-compassion, affiliative affect, and decreased self-criticism', 'parasympathetic activation (increased heart rate variability', 'reduced arousal (reduced heart rate and skin conductance']",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",135.0,0.0198568,"Increased self-reported-state self-compassion, affiliative affect, and decreased self-criticism were found after both self-compassion exercises and the positive-excitement condition.","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirschner', 'Affiliation': 'Mood Disorder Centre, College of Life and Environmental Sciences, University of Exeter.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Mood Disorder Centre, College of Life and Environmental Sciences, University of Exeter.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Wright', 'Affiliation': 'Mood Disorder Centre, College of Life and Environmental Sciences, University of Exeter.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': 'Mood Disorder Centre, College of Life and Environmental Sciences, University of Exeter.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Brejcha', 'Affiliation': 'Mood Disorder Centre, College of Life and Environmental Sciences, University of Exeter.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Karl', 'Affiliation': 'Mood Disorder Centre, College of Life and Environmental Sciences, University of Exeter.'}]",Clinical psychological science : a journal of the Association for Psychological Science,['10.1177/2167702618812438']
2310,32656047,Efficacy of a Multimodal Online Lifestyle Intervention for Depressive Symptoms and Quality of Life in Individuals With a History of Major Depressive Disorder.,"Background Major depressive disorder (MDD) is a complex bio-psycho-social syndrome that affects millions of individuals and is one of the leading causes of impaired quality of life (QOL). In addition to the symptoms of depression and low mood, many individuals with MDD also suffer from isolation without the sense of a supportive, surrounding community. Given the challenges of treating individuals with MDD, social isolation and a lack of communal connection, this randomized controlled trial was designed to determine the efficacy of a multimodal, online and community-based lifestyle intervention for improving depressive symptoms and QOL in individuals with a history of MDD. Materials and methods The study enrolled 71 female or male participants between the ages of 20 and 64 with a self-reported BMI between 18.4 and 34.9 kg/m 2  and a history of MDD. Individuals were randomized to either participate in a 44-day multimodal, online, community-based lifestyle intervention or placed on a wait list where they would complete the intervention at a later date. The multimodal intervention involved a self-directed learning program where individuals were guided to make lifestyle changes including adopting a whole-foods diet, increasing movement, and adopting stress management and mindfulness practices. All participants completed the 36-Item Short Form Health Survey (SF-36), the Cleveland Clinic Center for Functional Medicine's Medical Symptoms Questionnaire (MSQ), and the Patient Health Questionnaire-9 (PHQ-9) before and after the online program to assess health-related QOL, overall symptom burden, and depressive symptom burden, respectively.  Results A total of 37 participants were randomized to participate in the multimodal intervention with 26 completing all three study questionnaires at both study time points; 34 participants were randomized to the wait list control group with 27 completing all three study questionnaires at both study time points. There were no clinically or statistically significant differences between the control group or the intervention group at baseline. The control group showed no clinically nor statistically significant changes in the MSQ, PHQ-9 or any of the eight subdomains of the SF-36 from the beginning to the end of the 10-week study period. When compared to the control group, the intervention group showed statistically and clinically significant improvements in median (M) scores of the SF-36 subdomains of vitality and mental health, and clinically but not statistically significant improvements in the subdomain of emotional role functioning. There were additional statistically and clinically significant improvements in the mean score of the MSQ and M scores of the PHQ-9 (treatment pre-intervention M = 10.5, inter-quartile range [IQR] = 14, to treatment post-intervention M = 5, IQR = 8.25; control pre-intervention M = 15, IQR = 8, to control post-intervention M = 13.5, IQR = 12.5). Conclusions  Our randomized controlled study provides evidence for the role of a multimodal, online and community-based lifestyle intervention to improve depressive symptoms, QOL, and total symptom burden in individuals with a history of MDD. Given the growing challenges of effectively supporting individuals suffering with MDD, it appears critical to further explore the utilization of novel, multimodal and self-directed lifestyle interventions.",2020,"The control group showed no clinically nor statistically significant changes in the MSQ, PHQ-9 or any of the eight subdomains of the SF-36 from the beginning to the end of the 10-week study period.","['71\xa0female or male participants between the ages of 20 and 64 with a self-reported BMI\xa0between 18.4 and 34.9 kg/m 2\xa0 and a history of MDD', 'individuals suffering with MDD', '37 participants were randomized to participate in the multimodal intervention with 26 completing all three study questionnaires at both study time points; 34\xa0participants', 'Individuals With a History of Major Depressive Disorder', 'individuals with a history of MDD']","['multimodal, online and community-based lifestyle intervention', 'self-directed learning program where individuals were guided to make lifestyle changes including adopting a whole-foods\xa0diet, increasing movement, and adopting stress management and mindfulness practices', '44-day multimodal, online, community-based lifestyle intervention', 'multimodal, online and community-based\xa0lifestyle intervention', 'Multimodal Online Lifestyle Intervention']","['subdomain of emotional role functioning', 'depressive symptoms, QOL, and total symptom burden', 'MSQ, PHQ-9', 'median (M) scores of the SF-36\xa0subdomains of\xa0vitality and mental health', ""36-Item Short Form Health Survey (SF-36), the Cleveland Clinic\xa0Center for Functional Medicine's Medical Symptoms Questionnaire (MSQ), and the Patient Health Questionnaire-9 (PHQ-9"", 'Depressive Symptoms and Quality of Life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040227', 'cui_str': 'Time Studies'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",37.0,0.0577348,"The control group showed no clinically nor statistically significant changes in the MSQ, PHQ-9 or any of the eight subdomains of the SF-36 from the beginning to the end of the 10-week study period.","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Abbott', 'Affiliation': 'Integrative/Complementary Medicine, Resilient Roots, Charlottesville, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Sherwin', 'Affiliation': 'Osteopathic Medicine, Midwestern University Arizona College of Osteopathic Medicine, Glendale, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Klopf', 'Affiliation': 'Osteopathic Medicine, Rocky Vista University College of Osteopathic Medicine, Denver, USA.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Mattingly', 'Affiliation': 'Counseling and Human Development, Lindsey Wilson College, Columbia, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Brogan', 'Affiliation': 'Psychiatry and Behavioral Sciences, Independent Researcher, Miami, USA.'}]",Cureus,['10.7759/cureus.9061']
2311,32656121,Comparative Study of Minimally Invasive Lumbar Decompression versus Decompressive Laminectomy with Posterolateral Transpedicular Fixation for the Treatment of Degenerative Lumbar Canal Stenosis.,"Background


The classic laminectomy for spinal decompression was the treatment of choice of the degenerative lumbar canal stenosis (LCS). Many surgeons prefer to add instrumented lumbar fusion to avoid future instability after the removal of posterior elements. Adding fusion is associated with more bleeding and longer periods of hospitalization. Minimally invasive lumbar decompression (MILD) has been advocated for successful decompression with less bleeding loss and shorter hospitalization.
Aim of the Work


To evaluate and compare the clinical outcomes of two different treatment modalities for degenerative LCS: the classic laminectomy with posterolateral transpedicular screw fixation and the MILD.
Patients and Methods


Fifty patients with degenerative LCS were randomized from two institutions: Ain Shams University Hospital and Arab Contractors Medical Center, who underwent surgeries for degenerative LCS between 2016 and 2018 with 1-year follow-up. The study compared two cohorts: Group A - 25 patients underwent classic lumbar laminectomy with posterolateral transpedicular fixation, and Group B - 25 patients underwent MILD.
Results


There were no statistically significant differences between both treatment modalities in the VAS for leg pain and back pain, the patient satisfaction index, and the Oswestry disability index after 1 year. The fusion operations were associated with higher estimates of blood loss, longer hospital stay, and more financial costs.
Conclusion


MILD has the same satisfactory results as classic laminectomy with posterolateral fixation for the treatment of degenerative LCS with less bleeding loss and shorter hospitalization. Since the results are comparable, MILD is suggested in low-income countries as Egypt for economic reasons.",2020,"There were no statistically significant differences between both treatment modalities in the VAS for leg pain and back pain, the patient satisfaction index, and the Oswestry disability index after 1 year.","['Degenerative Lumbar Canal Stenosis', 'Patients and Methods\n\n\nFifty patients with degenerative LCS were randomized from two institutions', 'Ain Shams University Hospital and Arab Contractors Medical Center, who underwent surgeries for degenerative LCS between 2016 and 2018 with 1-year follow-up', '25 patients underwent MILD', 'degenerative LCS']","['classic lumbar laminectomy with posterolateral transpedicular fixation, and Group B ', 'Minimally Invasive Lumbar Decompression versus Decompressive Laminectomy with Posterolateral Transpedicular Fixation', 'Minimally invasive lumbar decompression (MILD', 'posterolateral transpedicular screw fixation and the MILD']","['blood loss, longer hospital stay, and more financial costs', 'VAS for leg pain and back pain, the patient satisfaction index, and the Oswestry disability index']","[{'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0442371', 'cui_str': 'Transpedicular approach'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C1306561', 'cui_str': 'Decompression laminectomy'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",50.0,0.0276675,"There were no statistically significant differences between both treatment modalities in the VAS for leg pain and back pain, the patient satisfaction index, and the Oswestry disability index after 1 year.","[{'ForeName': 'Ahmed Reda', 'Initials': 'AR', 'LastName': 'Aldahshory', 'Affiliation': 'Department of Neurosurgery, Arab Contractors Medical Center, Nasr city, Cairo Governorate, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Mashaly', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Ain Shams University, Nasr city, Cairo Governorate, Egypt.'}, {'ForeName': 'Shafik Tahseen', 'Initials': 'ST', 'LastName': 'El Molla', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Ain Shams University, Nasr city, Cairo Governorate, Egypt.'}, {'ForeName': 'Ibrahim Abdelmohsen', 'Initials': 'IA', 'LastName': 'Ismaiel', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Ain Shams University, Nasr city, Cairo Governorate, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Saoud', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Ain Shams University, Nasr city, Cairo Governorate, Egypt.'}]",Asian journal of neurosurgery,['10.4103/ajns.AJNS_132_20']
2312,32656160,Pharmacokinetics and bioequivalence of fixed-dose combination of candesartan cilexetil/amlodipine besylate (16/10 mg) versus coadministration of individual formulations in healthy subjects.,"This study compared the pharmacokinetics of a fixed-dose combination (FDC) of candesartan (16 mg) and amlodipine (10 mg) versus coadministration of individual formulations to clarify the bioequivalence of the FDC. In this randomized, open-label, single-dose, 2-treatment, 2-way crossover study, healthy Korean volunteers received a single dose of candesartan (16 mg) with amlodipine (10 mg) as either an FDC or single agents concomitantly administered, with a 2-week washout period. Serial blood samples were collected up to 72 hours after dosing for each treatment period, and plasma concentrations of candesartan and amlodipine were measured using a validated liquid chromatography-tandem mass spectrometry method. A total of 39 subjects completed the study. The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for the area under the plasma concentration-time curve from time 0 to the last measurement (AUC 0-t ) and the peak plasma concentration (C max ) for candesartan were 1.0182 (0.9562-1.0841) and 0.9492 (0.8726-1.0324), respectively. The GMR and 90% CI for the AUC 0-t  and C max  for amlodipine were 1.0552 (1.0255-1.0857) and 1.0668 (1.0259-1.1094), respectively. In conclusion, the new FDC formulation of candesartan (16 mg) and amlodipine (10 mg) was bioequivalent to the concomitant administration of single agents. A single dose of candesartan/amlodipine as the FDC or as single agents was well tolerated.
Trial Registration


ClinicalTrials.gov Identifier: NCT02988362.",2020,"The GMR and 90% CI for the AUC 0-t  and C max  for amlodipine were 1.0552 (1.0255-1.0857) and 1.0668 (1.0259-1.1094), respectively.","['39 subjects completed the study', 'healthy Korean volunteers', 'healthy subjects']","['fixed-dose combination (FDC) of candesartan', 'candesartan/amlodipine', 'amlodipine', 'candesartan', 'candesartan cilexetil/amlodipine besylate', 'candesartan and amlodipine']","['Serial blood samples', 'tolerated', 'peak plasma concentration (C max ', 'geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for the area under the plasma concentration-time curve', 'AUC 0-t  and C max']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0527379', 'cui_str': 'Candesartan cilexetil'}, {'cui': 'C0354468', 'cui_str': 'Amlodipine besylate'}, {'cui': 'C3700408', 'cui_str': 'candesartan and amlodipine'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",39.0,0.0342066,"The GMR and 90% CI for the AUC 0-t  and C max  for amlodipine were 1.0552 (1.0255-1.0857) and 1.0668 (1.0259-1.1094), respectively.","[{'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Woo Youl', 'Initials': 'WY', 'LastName': 'Kang', 'Affiliation': 'School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Wookjae', 'Initials': 'W', 'LastName': 'Jung', 'Affiliation': 'School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Mi-Ri', 'Initials': 'MR', 'LastName': 'Gwon', 'Affiliation': 'School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Dong Heon', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu 41944, Korea.'}, {'ForeName': 'Eun Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Daegu Catholic University, Gyeongsan 38430, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Cho', 'Affiliation': 'Analytical Research Division, Biocore Co. Ltd., Seoul 08511, Korea.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Sook Jin', 'Initials': 'SJ', 'LastName': 'Seong', 'Affiliation': 'School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2020.28.e8']
2313,32656161,Pharmacokinetic comparison of two bazedoxifene acetate 20 mg tablet formulations in healthy Korean male volunteers.,"Bazedoxifene, used as bazedoxifene acetate, is a selective estrogen receptor modulator that selectively affects the uterus, breast tissue, bone metabolism, and lipid metabolism by antagonizing or enhancing estrogens in the estrogen receptor in the tissue. This study was conducted as an open, randomized, two-period, two-treatment, crossover design to compare the pharmacokinetic (PK) characteristics and tolerability of two bazedoxifene tablets when administered to 50 healthy Korean male volunteers. Enrolled subjects were randomly allocated to 2 sequences of a single oral administration of a test drug and a reference drug, or vice versa with a 14-day washout period between the two doses. Serial blood samples were collected over 96 h for PK analysis. Plasma concentration of bazedoxifene was assayed using liquid chromatography-tandem spectrometry mass. Forty-five participants completed the study with no clinically relevant safety issues. The peak concentrations (C max , mean ± strandard deviation) of reference drug and test drug were 3.191 ± 1.080 and 3.231 ± 1.346 ng/mL, respectively, and the areas under the plasma concentration-time curve from 0 to the last measurable concentration (AUC last ) were 44.697 ± 21.168 ng∙h/mL and 45.902 ± 23.130 ng∙h/mL, respectively. The geometric mean ratios of test drug to reference drug and their 90% confidence intervals for C max  and AUC last  were 0.9913 (0.8828-1.1132) and 1.0106 (0.9345-1.0929), respectively. The incidence of adverse events between the two formulations was similar. The present study showed that PK and tolerability of two bazedoxifene tablet formulations were comparable when administered to healthy Korean male volunteers.
Trial Registration


Clinical Research Information Service Identifier: KCT0003978.",2020,"AUC last  were 0.9913 (0.8828-1.1132) and 1.0106 (0.9345-1.0929), respectively.","['healthy Korean male volunteers', '50 healthy Korean male volunteers']","['bazedoxifene tablet formulations', 'bazedoxifene tablets', 'bazedoxifene acetate 20 mg tablet formulations', 'Bazedoxifene', 'bazedoxifene acetate']","['Serial blood samples', 'PK and tolerability', 'geometric mean ratios', 'adverse events', 'pharmacokinetic (PK) characteristics and tolerability', 'Plasma concentration of bazedoxifene', 'peak concentrations (C max , mean ± strandard deviation) of reference drug and test drug']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C2346970', 'cui_str': 'bazedoxifene'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C1571574', 'cui_str': 'Bazedoxifene acetate'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2346970', 'cui_str': 'bazedoxifene'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}]",,0.134655,"AUC last  were 0.9913 (0.8828-1.1132) and 1.0106 (0.9345-1.0929), respectively.","[{'ForeName': 'Ji-Sun', 'Initials': 'JS', 'LastName': 'Yeun', 'Affiliation': 'Clinical Trials Center, Chungnam National University Hospital, Daejeon 34134, Korea.'}, {'ForeName': 'Hye-Su', 'Initials': 'HS', 'LastName': 'Kan', 'Affiliation': 'Center for Infectious Diseases Control, Korea Centers for Disease Control and Prevention, Cheongju 28159, Korea.'}, {'ForeName': 'Minyu', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Namsick', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Oh', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Seung-Kwan', 'Initials': 'SK', 'LastName': 'Nam', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'Yoon Seok', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Huons Co., Ltd, Seongnam 13486, Korea.'}, {'ForeName': 'In Sun', 'Initials': 'IS', 'LastName': 'Kwon', 'Affiliation': 'Clinical Trials Center, Chungnam National University Hospital, Daejeon 34134, Korea.'}, {'ForeName': 'Jang Hee', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': 'Clinical Trials Center, Chungnam National University Hospital, Daejeon 34134, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2020.28.e7']
2314,32656163,Call Me Maybe… A Simulation Based Curriculum for Telephone Triage Education in a Pediatric Residency.,"Pediatrician communication with caregivers by phone has traditionally made a significant impact on patient care but remains a source of medical liability. Despite its importance, few publications exist regarding the education of pediatric residents on telephone triage. Our study involved the development of an educational curriculum aimed at expanding the pediatric resident skill set in telephone triage. Our method of curriculum development is based on Kolb's experiential learning theory. We utilized a combination of resource familiarization, didactic education, and simulation in the building of knowledge through reflection upon concrete experience, generalization of knowledge gained, and application of this new knowledge. We developed a 30-min PowerPoint presentation in which instructors reviewed the basic tenets of telephone triage. In the pilot study, residents were divided into two groups-a didactic-first group and a simulation-first group. Their performance was monitored during two scripted, symptom based ""parent"" phone call simulations. The didactic-first group received the PowerPoint didactic prior to the simulation, and the simulation-first group received the didactic after the simulation. A comparison of resident evaluations by faculty and self-documented confidence level revealed statistically significant higher evaluation scores in the didactic-first group, and an overall improvement in resident confidence with telephone triage. We conclude that this educational curriculum may improve pediatric resident performance in telephone triage.",2020,"A comparison of resident evaluations by faculty and self-documented confidence level revealed statistically significant higher evaluation scores in the didactic-first group, and an overall improvement in resident confidence with telephone triage.",[],"['PowerPoint didactic', 'didactic-first group and a simulation-first group']",['pediatric resident performance'],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",,0.0242952,"A comparison of resident evaluations by faculty and self-documented confidence level revealed statistically significant higher evaluation scores in the didactic-first group, and an overall improvement in resident confidence with telephone triage.","[{'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Blumberg', 'Affiliation': 'Department of Clinical Sciences, University of Houston College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Barajaz', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, San Antonio, TX, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Roberts', 'Affiliation': 'Section of Neonatology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Clary', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, San Antonio, TX, United States.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Center for Research, Innovation and Scholarship in Medical Education, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, United States.""}]",Frontiers in pediatrics,['10.3389/fped.2020.00283']
2315,32656217,"Randomized, Placebo-Controlled, Double-Blind and Open-Label Studies in the Treatment and Prevention of Acute Diarrhea With  Enterococcus faecium  SF68.","Enterococcus faecium  SF68® (SF68) is a licensed pharmaceutical for treatment and prevention of diarrhea in Austria, Italy and Switzerland. However, as for other probiotics, evidence for its efficacy is based on small to medium-sized studies. Four unpublished studies on the treatment of acute diarrhea and the prevention of antibiotic-associated diarrhea were analyzed: one randomized, double blind, placebo-controlled trial (RCT) for treatment ( n  = 1,143), one open-label study for treatment ( n  = 5,093), one RCT for prevention ( n  = 1,397) and one open-label study for prevention ( n  = 4,340). Patients in the treatment-arm and the open-label studies received SF68 (b.i.d. for the prevention studies, t.i.d. for the treatment trials) for 7 days. Primary end points were time to resolution of diarrhea (treatment) and percentage of development of diarrhea (prevention). The primary endpoint of the treatment study was met with a decreased time to resolution of diarrhea in SF68-treated patients compared to controls (median 3 vs. 4 days,  p  < 0.001). Time to resolution of secondary symptoms was also significantly reduced. Preventive treatment with SF68 was more effective than placebo with development of diarrhea in 8.6 vs. 16.2% ( p  < 0.001). Results from the open-label studies were consistent with the RCTs. The incidence of adverse events were low (1.1 and 1.4% in the RCT and 4.7 and 7.4% in the open-label studies). SF68 is effective and safe in the treatment of acute diarrhea and prevention of antibiotic-associated diarrhea.",2020,"Enterococcus faecium  SF68® (SF68) is a licensed pharmaceutical for treatment and prevention of diarrhea in Austria, Italy and Switzerland.","[' n  = 1,397) and one open-label study for prevention ( n  = 4,340', 'Acute Diarrhea With  Enterococcus faecium  SF68']","['Placebo', 'Enterococcus faecium  SF68® (SF68', 'SF68', 'RCT for prevention', 'placebo']","['diarrhea', 'Time to resolution of secondary symptoms', 'incidence of adverse events', 'time to resolution of diarrhea', 'time to resolution of diarrhea (treatment) and percentage of development of diarrhea (prevention']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0085495', 'cui_str': 'Enterococcus faecium'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085495', 'cui_str': 'Enterococcus faecium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",,0.0789824,"Enterococcus faecium  SF68® (SF68) is a licensed pharmaceutical for treatment and prevention of diarrhea in Austria, Italy and Switzerland.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Greuter', 'Affiliation': 'Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Michel', 'Affiliation': 'Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Thomann', 'Affiliation': 'Sanofi-Aventis Schweiz GmbH, Vernier, Switzerland.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Weigmann', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Stephan R', 'Initials': 'SR', 'LastName': 'Vavricka', 'Affiliation': 'Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.'}]",Frontiers in medicine,['10.3389/fmed.2020.00276']
2316,32656273,The Effect of Peer Education on Self-Care Behaviors and the Mean of Glycosylated Hemoglobin in Adolescents with Type 1 Diabetes: A Randomized Controlled Clinical Trial.,"Background


Diabetes control in adolescents is a difficult and tedious process. Diabetic teens need training to control it and prevent its complications. This study aimed to investigate the effect of peer education on self-care behaviors and glycosylated hemoglobin among adolescents with type 1 diabetes.
Methods


This controlled clinical trial was conducted in Iran from July 2018 to June 2019. 84 teenagers with type 1 diabetes were selected using a simple random sampling and randomly divided into control and intervention groups using block randomization. The intervention group received 4 sessions of training by peers on self care behaviors in diabetes. The control group received the routine training. The self-care questionnaire was filled out, and glycosylated hemoglobin was measured before and three months after the intervention. Data were analyzed using SPSS version 23.0. The significance level was set at P<0.0.
Results


Three months after the intervention, the intervention group reported significantly higher levels of score of self-care behaviors (P<0.001) and lower levels of mean glycosylated hemoglobin (P<0.001), as compared with the control. Also, the mean self-care score was not significantly different in the control group before and three months after the intervention (P>0.05). Besides, the mean glycosylated hemoglobin significantly increased three months after the intervention in the controls (P<0.001).
Conclusion


The implementation of peer education can improve the self-care behaviors and glycosylated hemoglobin in adolescents. Hence, regarding its low cost and high safety, it is suggested that this approach should be established in the control of other chronic diseases in order to strengthen the self-care behaviors in adolescents. Trial Registration Number:  IRCT20180904040944N1.",2020,"Also, the mean self-care score was not significantly different in the control group before and three months after the intervention (P>0.05).","['Diabetic teens', 'Iran from July 2018 to June 2019', 'adolescents with type 1 diabetes', 'Adolescents with Type 1 Diabetes', '84 teenagers with type 1 diabetes', 'adolescents']","['routine training', '4 sessions of training by peers on self care behaviors in diabetes', 'Peer Education', 'peer education']","['mean self-care score', 'mean glycosylated hemoglobin', 'Self-Care Behaviors', 'levels of score of self-care behaviors', 'levels of mean glycosylated hemoglobin', 'glycosylated hemoglobin']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0393855,"Also, the mean self-care score was not significantly different in the control group before and three months after the intervention (P>0.05).","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Edraki', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Zarei', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Soltanian', 'Affiliation': 'Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Moravej', 'Affiliation': 'Department of Pediatrics, School of Medicine, Shiraz University of Medical Science, Shiraz, Iran.'}]",International journal of community based nursing and midwifery,['10.30476/ijcbnm.2020.82296.1051']
2317,32656275,The Impact of Educational Intervention on the Anxiety of Family Caregivers of the Elderly with Dementia: A Randomized Controlled Trial.,"Background


Due to the increasing population of elderly and the consequent increase in the number of chronic diseases such as dementia, the psychological complications such as anxiety in the family caregivers increase. The aim of this study was to determine the effect of educational intervention on the anxiety of family caregivers of the elderly people with dementia.
Methods


This randomized controlled trial was performed in the elderly Neurology Clinics in Shiraz from May to August 2017. This study was conducted on 70 families with elderly people with dementia who were randomly divided into an intervention (receiving in groups for seven sessions of educational intervention) and a control group (Conventional care). Data collection tool was Spielberger's Anxiety Inventory (40-items, score=20-80). Data were analyzed by SPSS version 21 using ANOVA test with repeated measures and independent t-test.
Results


One and three months after the interventions, the mean scores of anxiety in the intervention group were 70.51±3.78 and 70.31±3.43 and in the control groups they were 76.45±3.45 and 76.22±5.08 respectively. The results showed significant differences between the two groups regarding anxiety after the intervention (P<0.001).
Conclusion


Educational programs held to promote and maintain the physical and mental health of caregivers could reduce the anxiety of family caregivers of the elderly with dementia. Trial Registration Number:  IRCT2017080915426N4.",2020,"The results showed significant differences between the two groups regarding anxiety after the intervention (P<0.001).
","['Family Caregivers of the Elderly with Dementia', 'elderly Neurology Clinics in Shiraz from May to August 2017', '70 families with elderly people with dementia who were randomly divided into an', 'family caregivers of the elderly people with dementia']","['intervention (receiving in groups for seven sessions of educational intervention', 'educational intervention', 'Educational Intervention', 'control group (Conventional care']","['mean scores of anxiety', 'anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",70.0,0.06808,"The results showed significant differences between the two groups regarding anxiety after the intervention (P<0.001).
","[{'ForeName': 'Abdolrahman', 'Initials': 'A', 'LastName': 'Zarepour', 'Affiliation': 'Student Research Committee,Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hazrati', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali Akbaar', 'Initials': 'AA', 'LastName': 'Kadivar', 'Affiliation': 'Department of Neurology, school of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",International journal of community based nursing and midwifery,['10.30476/ijcbnm.2020.81680.0']
2318,32656278,How Hospital Tours Affect Preoperative Anxiety in Mothers with Children Undergoing Open-Heart Surgery in Iran: A Quasi-Experimental Study.,"Background


Parents tend to experience considerable amounts of anxiety before their children undergo open heart surgery. This study was conducted to assess the effects of taking a hospital tour on preoperative anxiety in the mothers of children undergoing open heart surgery.
Methods


In this quasi-experimental study, 96 mothers from Shahid Modarres Hospital in Tehran, Iran, during April to December 2018, were selected through convenience sampling and were assigned to three groups using simple randomization. The oral instruction group (N=32) attended two oral instruction sessions; the hospital tour group (N=32) participated in tours of the operation room and intensive care unit; the control group (N=32) was prepared according to the ward's routine. Preoperative anxiety was evaluated using the Amsterdam Preoperative Anxiety and Information Scale and the State Trait Anxiety Inventory. Data were analyzed in SPSS-20. The ANOVA, paired t-test and Tukey's test were used for the data analysis. The level of statistical significance was set at P<0.05.
Results


The mothers' anxiety about surgery (F=30.99, P≤0.001) and their scores of state anxiety (F=6.02, P<0.001) differed significantly among the three groups after the intervention. A significant difference was observed between the oral instruction and control groups (P<0.001) and the hospital tour and control groups (P<0.001) regarding the surgery-related anxiety scores. A significant difference was also observed between the oral instruction and control groups (P=0.002) regarding the mothers' state anxiety scores.
Conclusions


The results suggest the greater efficiency of oral instructions versus hospital tours. Nurses can use oral instructions for reducing surgery-related anxiety and state anxiety of mothers before their toddlers' open heart surgery. Trial Registration Number:  IRCT20180904040944N1.",2020,A significant difference was observed between the oral instruction and control groups (P<0.001) and the hospital tour and control groups (P<0.001) regarding the surgery-related anxiety scores.,"['mothers of children undergoing open heart surgery', '96 mothers from Shahid Modarres Hospital in Tehran, Iran, during April to December 2018', 'Mothers with Children Undergoing Open-Heart Surgery in Iran']","['hospital tour', 'oral instruction group (N=32) attended two oral instruction sessions; the hospital tour group (N=32) participated in tours of the operation room and intensive care unit; the control group']","[""mothers' anxiety about surgery"", 'Preoperative anxiety', 'scores of state anxiety', 'surgery-related anxiety scores', 'preoperative anxiety', ""mothers' state anxiety scores"", 'Amsterdam Preoperative Anxiety and Information Scale and the State Trait Anxiety Inventory']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",96.0,0.0314322,A significant difference was observed between the oral instruction and control groups (P<0.001) and the hospital tour and control groups (P<0.001) regarding the surgery-related anxiety scores.,"[{'ForeName': 'Asal', 'Initials': 'A', 'LastName': 'Amintojari', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Manijeh', 'Initials': 'M', 'LastName': 'Nourian', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Nikfarid', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parasto', 'Initials': 'P', 'LastName': 'Ojian', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Biostatistics, School of Nursing and midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",International journal of community based nursing and midwifery,['10.30476/ijcbnm.2020.82761.1084']
2319,32656492,A low dosage of the dopamine D2-receptor antagonist sulpiride affects effort allocation for reward regardless of trait extraversion.,"Dopamine (DA) is known to be involved in various aspects of reward processing and goal-directed behavior. The present preregistered study aims at directly accessing the causal influence of DA activity on reward motivation in humans, while also accounting for trait extraversion. Therefore, we examined the effect of a single dose of the DA D2 receptor antagonist sulpiride (200 mg) on effort allocation in a modified version of the Effort-Expenditure for Reward Task (EEfRT). Based on its presumably DA increasing action, we expected the low dose of sulpiride to increase participants' willingness to allocate effort during the modified EEfRT relative to placebo, especially in trials with low probability of reward attainment. Further, we expected a moderating effect of trait extraversion on the effects of sulpiride. Two hundred and three healthy male participants were tested in a randomized, double-blind between-subjects design. Contrary to our expectations, sulpiride reduced the average number of clicks within the modified EEfRT and did not interact with reward attributes, suggesting a more global and not reward-specific effect of sulpiride. Furthermore, trait extraversion did not moderate the effect of sulpiride. Our results provide initial support for the validity of the modified version of the EEfRT, suggesting a possible inhibiting effect of a low dose of sulpiride on approach motivation regardless of trait extraversion. However, given the mixed pattern of findings and the possible confounding role of motoric abilities, further studies examining these effects are clearly warranted.",2020,"Contrary to our expectations, sulpiride reduced the average number of clicks within the modified EEfRT and did not interact with reward attributes, suggesting a more global and not reward-specific effect of sulpiride.",['Two hundred and three healthy male participants'],"['DA D2 receptor antagonist sulpiride', 'Dopamine (DA']",[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C3850099', 'cui_str': 'Receptor Antagonists, Dopamine D2'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]",[],203.0,0.116626,"Contrary to our expectations, sulpiride reduced the average number of clicks within the modified EEfRT and did not interact with reward attributes, suggesting a more global and not reward-specific effect of sulpiride.","[{'ForeName': 'Hanno Andreas', 'Initials': 'HA', 'LastName': 'Ohmann', 'Affiliation': 'Faculty of Psychology and Human Movement Science, Universität Hamburg, Hamburg, Germany.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Kuper', 'Affiliation': 'Faculty of Psychology and Human Movement Science, Universität Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wacker', 'Affiliation': 'Faculty of Psychology and Human Movement Science, Universität Hamburg, Hamburg, Germany.'}]",Personality neuroscience,['10.1017/pen.2020.7']
2320,32656664,"Effects of caffeine intake on the biomechanical properties of the cornea: a placebo-controlled, double-blind, crossover pilot study in low caffeine consumers.","PURPOSE


To assess the short-term effects of caffeine intake on the biomechanical properties of the cornea, as well as its possible association with the intraocular pressure (IOP), as measured by corneal visualization Scheimpflug technology (CorVis ST) in healthy subjects.
METHODS


Twenty-two low caffeine consumers ingested either a caffeine (4 mg/Kg) or placebo capsule in two separate sessions. IOP and corneal biomechanics parameters, including time, velocity, length, and deformation amplitude at the first applanation (A1T, A1V, A1L, and A1D, respectively); time, velocity, length, and deformation amplitude at the second applanation (A2T, A2V, A2L, and A2D, respectively); time at the highest concavity (HCT), radius curvature at the highest concavity (HCR), deformation amplitude at the highest concavity (HCDA), and peak distance (PD), were measured with the Corvis ST before and after 30 min, 60 min, and 90 min of caffeine/placebo intake.
RESULTS


Caffeine intake reduced the corneal deformability, inducing significant changes in A1T, A2V, A2T, HCDA, HCT, and PD (all p values < 0.05). Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively). Also, the changes in IOP after caffeine intake were positively associated with A1T (r = 0.790 to 0.962), and negatively associated with A2T (r = - 0.230 to - 0.722) and PD (r = - 0.506 to - 0.644).
CONCLUSIONS


Caffeine intake reduces the corneal deformability, with these changes being partially associated with the IOP rise. These findings evidence that exogenous factors such as caffeine intake should be taken into consideration when making clinical decisions that are based on the biomechanical properties of the cornea.",2020,"Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively).","['healthy subjects', 'low caffeine consumers', 'Twenty-two low caffeine consumers ingested either a']","['caffeine intake', 'caffeine', 'caffeine/placebo', 'caffeine (4\xa0mg/Kg) or placebo capsule', 'placebo']","['biomechanical properties of the cornea', 'IOP values', 'changes in IOP', 'IOP and corneal biomechanics parameters, including time, velocity, length, and deformation amplitude at the first applanation (A1T, A1V, A1L, and A1D, respectively); time, velocity, length, and deformation amplitude at the second applanation (A2T, A2V, A2L, and A2D, respectively); time at the highest concavity (HCT), radius curvature at the highest concavity (HCR), deformation amplitude at the highest concavity (HCDA), and peak distance (PD', 'A1T, A2V, A2T, HCDA, HCT, and PD', 'intraocular pressure (IOP', 'corneal deformability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0625485', 'cui_str': '5,9-hexacosadienoic acid'}]",22.0,0.0561261,"Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively).","[{'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain. beatrizrc@ugr.es.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04835-0']
2321,32656692,Pilot Randomized Controlled Trial of an Interconception Intervention Provided by Public Health Nurses.,"OBJECTIVES


Preconception health impacts perinatal outcomes, but the difficulty in engaging reproductive-aged individuals in health promotion activities is a barrier to effective implementation of preconception interventions. Since most women have more than one pregnancy and many risk factors repeat across pregnancies, the time between pregnancies-the interconception period-may be an opportune time to improve health. Our objective was to examine the feasibility and acceptability of an interconception intervention delivered by public health nurses.
METHODS


We conducted a pilot randomized controlled trial in three small urban and rural public health units in Ontario, Canada, in 2017-2018 among women who were ≥ 18 years of age and between 2 and 12 months postpartum after a first birth. Women randomly allocated to the intervention group received a preconception risk assessment, tailored health education, and referral for clinical follow-up as needed, while those in the control group received standard care. Primary outcomes were intervention feasibility, adherence, and acceptability.
RESULTS


Of 66 eligible women, 61% agreed to participate and were randomized to the intervention (n = 16) or control (n = 24) groups. The follow-up rate was 78% at 1 month and 71% at 3 months. Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
CONCLUSIONS FOR PRACTICE


Results demonstrate the potential feasibility and acceptability of an interconception intervention delivered in a public health setting. The short- and long-term impacts of the intervention on knowledge, behavior, and health should be tested in a larger sample.",2020,"Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
","['engaging reproductive-aged individuals in health promotion activities', '66 eligible women', 'Public Health Nurses', '18\xa0years of age and between 2 and 12\xa0months postpartum after a first birth', 'three small urban and rural public health units in Ontario, Canada, in 2017-2018 among women who were\u2009≥']","['interconception intervention', 'preconception risk assessment, tailored health education, and referral for clinical follow-up as needed, while those in the control group received standard care', 'Interconception Intervention']","['feasibility and acceptability', 'knowledge, behavior, and health', 'intervention feasibility, adherence, and acceptability', 'number and length of sessions and content of recommendations']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034022', 'cui_str': 'Public health nurse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0016145', 'cui_str': 'First Birth'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",66.0,0.0888779,"Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
","[{'ForeName': 'Saranyah', 'Initials': 'S', 'LastName': 'Ravindran', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shaira', 'Initials': 'S', 'LastName': 'Yoganathan', 'Affiliation': 'Interdisciplinary Centre for Health & Society, University of Toronto Scarborough, Toronto, ON, Canada.'}, {'ForeName': 'Zoe F', 'Initials': 'ZF', 'LastName': 'Cairncross', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cindy-Lee', 'Initials': 'CL', 'LastName': 'Dennis', 'Affiliation': ""Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enders', 'Affiliation': 'Ontario Public Health Association, Toronto, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Graves', 'Affiliation': 'Department of Family and Community Medicine, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Mill', 'Affiliation': 'Ontario Public Health Association, Toronto, ON, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Telner', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. hk.brown@utoronto.ca.'}]",Maternal and child health journal,['10.1007/s10995-020-02980-w']
2322,32656706,Development of a new risk model for a prognostic prediction after transcatheter aortic valve replacement.,"BACKGROUND


Current guidelines for transcatheter aortic valve replacement (TAVR) recommend that TAVR should be performed in patients with a life expectancy > 1 year. However, it is challenging to estimate the patients' life expectancy because it is related to various factors, including frailty and nutritional status.
HYPOTHESIS


A new risk model can estimate the prognosis of patients after TAVR.
METHODS


We randomly divided 388 patients with aortic stenosis (AS) undergoing TAVR from October 2009 to August 2016 into two groups (2:1 ratio; training cohort, 259; validation cohort, 129). Using 94 baseline factors in the training cohort, we developed possible scoring models by the Cox proportional hazard regression model with the overall survival as the endpoint. Then, cross-validated 5-year C-statistics were calculated to assess the accuracy of the model.
RESULTS


Of 94 baseline factors, 12 factors were finally identified (5-year C-statistics in the training cohort: 0.709)-age, gender, body mass index, left ventricular ejection fraction, % vital capacity, forced expiratory volume 1.0 (s) %, albumin, hemoglobin, creatine, platelet, creatine kinase, and prothrombin time-international normalized ratio. The cross-validated 1-, 3-, and 5-year C-statistics in the validation cohort were 0.792, 0.758, and 0.778, respectively. Furthermore, calibration plots in the validation cohort revealed that 5-year survival is well predicted (r = 0.962).
CONCLUSIONS


The new survival prediction model after TAVR could provide appropriate guidance during decision making regarding the TAVR implementation.",2020,"Furthermore, calibration plots in the validation cohort revealed that 5-year survival is well predicted (r = 0.962).
","['patients with a\xa0life expectancy\u2009>\u20091\xa0year', '388 patients with aortic stenosis (AS) undergoing TAVR from October 2009 to August 2016 into two groups (2:1 ratio; training cohort, 259; validation cohort, 129']","['transcatheter aortic valve replacement (TAVR', 'transcatheter aortic valve replacement']","['5-year survival', 'body mass index, left ventricular ejection fraction, % vital capacity, forced expiratory volume 1.0 (s) %, albumin, hemoglobin, creatine, platelet, creatine kinase, and prothrombin time-international normalized ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}]",388.0,0.0323344,"Furthermore, calibration plots in the validation cohort revealed that 5-year survival is well predicted (r = 0.962).
","[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kuratani', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Kyongsun', 'Initials': 'K', 'LastName': 'Pak', 'Affiliation': 'Division of Biostatistics, Center for Clinical Research, National Center for Child Health and Development, Setagaya, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Shimamura', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Mizote', 'Affiliation': 'Department of Cardiology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Miyagawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Division of Biostatistics, Center for Clinical Research, National Center for Child Health and Development, Setagaya, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. sawa-p@surg1.med.osaka-u.ac.jp.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-020-01436-w']
2323,32656729,"Liraglutide Augments Weight Loss After Laparoscopic Sleeve Gastrectomy: a Randomised, Double-Blind, Placebo-Control Study.","PURPOSE


Both laparoscopic sleeve gastrectomy (LSG) and liraglutide cause a significant weight loss. We evaluated the effect of liraglutide in comparison with placebo on total weight loss (TWL) and excess body weight loss (EWL) and when added in initial weight loss period after LSG in obese individuals.
MATERIAL AND METHODS


Participants with BMI > 30 kg/m 2  undergoing LSG were randomised to receive either liraglutide (subcutaneous) in increasing does of 0.6 mg/day until maximum tolerated dose of 3.0 mg (L-L group) or placebo (L-P group) from 6 weeks post-operative until 6 months. Weight, BMI, %TWL, %EWL, HbA1c, fasting plasma glucose, HOMA-IR, resolution of type 2 diabetes mellitus, hypertension, dyslipidaemia, sleep apnea and quality of life were evaluated. Primary end point was %TWL and % EWL at post-operative 6 months.
RESULTS


Thirty participants underwent LSG, and 23 were randomised to receive liraglutide (n = 12) or placebo (n = 11).The mean dose of liraglutide in L-L group was 1.41 ± 0.49 mg/day. Patients in L-L group had %TWL of 28.2 ± 5.7 and %EWL of 58.7 ± 14.3 as compared with 23.2 ± 6.2 (p = 0.116) and 44.5 ± 8.6 (p = 0.043) in L-P group at 24 weeks, respectively. BMI decreased by 11.7 ± 3.5 in L-L group compared with 9.5 ± 4.0 in L-P group (p = 0.287). All patients with diabetes or pre-diabetes had resolution of dysglycemia in the L-L group as compared with 50% in L-P group. However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up.
CONCLUSION


Liraglutide added early after LSG significantly augments weight loss from LSG in obese individuals.
TRIAL REGISTRATION


The study protocol was registered at clinical trials.gov.in with NCT: 04325581.",2020,"However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up.
","['Thirty participants underwent', 'obese individuals', 'Participants with BMI >\u200930\xa0kg', 'm 2  undergoing LSG']","['laparoscopic sleeve gastrectomy (LSG) and liraglutide', 'Placebo', 'liraglutide', 'Laparoscopic Sleeve Gastrectomy', 'Liraglutide', 'liraglutide (subcutaneous', 'LSG', 'placebo']","['resolution of dysglycemia', 'total weight loss (TWL) and excess body weight loss (EWL', 'Weight Loss', 'Weight, BMI, %TWL, %EWL, HbA1c, fasting plasma glucose, HOMA-IR, resolution of type 2 diabetes mellitus, hypertension, dyslipidaemia, sleep apnea and quality of life', 'BMI', 'weight loss', 'resolution of other obesity-related comorbidities']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0348480', 'cui_str': 'Other obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",30.0,0.171454,"However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up.
","[{'ForeName': 'Uttam', 'Initials': 'U', 'LastName': 'Thakur', 'Affiliation': 'Department of Gastro-intestinal Surgery, PGIMER, Chandigarh, Chandigarh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Bhansali', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, Room-1011, Nehru Hospital Extension Block, Chandigarh, 160012, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Gastro-intestinal Surgery, PGIMER, Chandigarh, Chandigarh, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Endocrinology, PGIMER, Chandigarh, Room-1011, Nehru Hospital Extension Block, Chandigarh, 160012, India. ashuendo@gmail.com.'}]",Obesity surgery,['10.1007/s11695-020-04850-4']
2324,31818048,Comparison of Effectiveness between Abdominal Vibration Stimulation and Walking Exercise for Bowel Cleansing before Therapeutic Colonoscopy.,"Background/Aims


Adequate bowel preparation is important for successful colonoscopy. We aimed to evaluate the clinical feasibility and effectiveness of abdominal vibration stimulation in bowel preparation before therapeutic colonoscopy.
Methods


A single center, prospective, randomized, investigator-blinded study was performed between January 2016 and December 2016. Patients for therapeutic colonoscopy were prospectively enrolled and assigned to either the vibrator group or walking group. Patients who refused to participate in this study as part of the experimental group consented to register in the control group instead. During the preparation period, patients assigned to the walking group walked ≥3,000 steps, whereas those assigned to the vibrator group received abdominal vibrator stimulation and restricted walking. All patients received the same colon cleansing regimen: 4-L split-dose polyethylene glycol (PEG) solution.
Results


Three hundred patients who received PEG solution for therapeutic colonoscopy were finally enrolled in this study (n=100 per group). Bowel cleansing with abdominal vibration stimulation showed almost similar results to that with walking exercise (Boston Bowel Preparation Scale score for the entire colon: vibrator vs walking vs control, 7.38±1.55 vs 7.39±1.55 vs 6.17±1.15, p<0.001). There were no significant differences between the vibrator group and walking group regarding instances of diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction.
Conclusions


This study indicates that, compared with conventional walking exercise, abdominal vibration stimulation achieved similar rates of bowel cleansing adequacy and colonoscopy success without compromising safety or patient satisfaction.",2020,"There were no significant differences between the vibrator group and walking group regarding instances of diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction.
","['January 2016 and December 2016', 'Patients who refused to participate in this study as part of the experimental group consented to register in the control group instead', 'Patients for therapeutic colonoscopy', 'Three hundred patients who received']","['PEG solution', 'vibrator group or walking group', 'Abdominal Vibration Stimulation and Walking Exercise', 'conventional walking exercise, abdominal vibration stimulation', 'vibrator group received abdominal vibrator stimulation and restricted walking', 'same colon cleansing regimen: 4-L split-dose polyethylene glycol (PEG) solution', 'abdominal vibration stimulation']","['walking exercise (Boston Bowel Preparation Scale score', 'diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0554063', 'cui_str': 'Therapeutic colonoscopy'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0184304', 'cui_str': 'Vibrator'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",300.0,0.0410102,"There were no significant differences between the vibrator group and walking group regarding instances of diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction.
","[{'ForeName': 'Choong-Kyun', 'Initials': 'CK', 'LastName': 'Noh', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'In Sung', 'Initials': 'IS', 'LastName': 'Kim', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Gil Ho', 'Initials': 'GH', 'LastName': 'Lee', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jin Woong', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Departments of Biomedical Informatics, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Bumhee', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Departments of Biomedical Informatics, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Hye Jeon', 'Initials': 'HJ', 'LastName': 'Hong', 'Affiliation': 'General Ward Nursing Unit, Ajou University Medical Center, Suwon, Korea.'}, {'ForeName': 'Sun Gyo', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jin Hong', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Kee Myung', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}]",Gut and liver,['10.5009/gnl19999']
2325,32598033,Effects of statins and exercise on postprandial lipoproteins in metabolic syndrome vs metabolically healthy individuals.,"AIMS


To determine if the combination of exercise and statin could normalize postprandial triglyceridaemia (PPTG) in hypercholesteraemic individuals.
METHODS


Eight hypercholesteraemic (blood cholesterol 182 ± 38 mg dL -1  ; low-density lipoprotein-cholesterol [LDL-c] 102 ± 32 mg dL -1  ) overweight (body mass index 30 ± 4 kg m -2  ) individuals with metabolic syndrome (MetS) were compared to a group of 8 metabolically healthy (MetH) controls (blood cholesterol 149 ± 23 mg dL -1  ; LDL-c 77 ± 23 mg dL -1  , and body mass index 23 ± 2 kg m -2  ). Each group underwent 2 PPTG tests, either 14 hours after a bout of intense exercise or without previous exercise. Additionally, MetS individuals were tested 96 hours after withdrawal of their habitual statin medication to study medication effects.
RESULTS


A bout of exercise before the test meal did not reduce PPTG in MetS (P = .347), but reduced PPTG by 46% in MetH (413 ± 267 to 224 ± 142 mg dL -1  for 5 h incremental area under the curve; P = .02). In both trials (i.e., either after a bout of intense exercise or without previous exercise), statin withdrawal in MetS greatly increased PPTG (average 65%; P < .01), mean LDL-c (average 25%; P < .01), total cholesterol (average 16%; P < .01) and apolipoprotein (Apo) B48 (24%; P < .01), without interference from exercise. However, Apo B100 was not affected by statin withdrawal.
CONCLUSION


Hypercholesteraemic MetS individuals (compared to MetH controls) fail to show an effect of exercise on reducing PPTG. However, chronic statin medication blunts the elevations in triglyceride after a fat meal (i.e., incremental area under the curve of PPTG) reducing their cardiovascular risk associated with their atherogenic dyslipidaemia. Statin decreases PPTG by reducing the secretion or accelerating the catabolism of intestinal Apo B48.",2020,"A bout of exercise before the test meal did not reduce PPTG in MetS (P = .347), but reduced PPTG by 46% in MetH (413 ± 267 to 224 ± 142 mg dL -1  for 5 h incremental area under the curve; P = .02).","['hypercholesteraemic individuals', '30 ± 4 kg m -2  ) individuals with metabolic syndrome (MetS', 'metabolic syndrome vs metabolically healthy individuals', 'Eight hypercholesteraemic (blood cholesterol 182 ± 38 mg dL -1  ; low-density lipoprotein-cholesterol', '102 ± 32 mg dL -1  ) overweight (body mass index']","['intense exercise or without previous exercise', 'LDL-c', 'exercise and statin', 'metabolically healthy (MetH) controls (blood cholesterol 149 ± 23 mg dL -1  ; LDL', 'apolipoprotein', 'statins and exercise']","['mean LDL-c', 'postprandial lipoproteins', 'PPTG in MetS', 'total cholesterol']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0267781,"A bout of exercise before the test meal did not reduce PPTG in MetS (P = .347), but reduced PPTG by 46% in MetH (413 ± 267 to 224 ± 142 mg dL -1  for 5 h incremental area under the curve; P = .02).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14447']
2326,32658496,The effect of feedback-informed cognitive behavioral therapy on treatment outcome: A randomized controlled trial.,"OBJECTIVE


Previous studies have shown that feedback-informed treatment can improve outcomes of psychological treatments. This randomized controlled effectiveness trial evaluated the effect of progress feedback on treatment duration, symptom reduction, and dropout in individual cognitive behavioral therapies (CBTs). A control condition where CBT was combined with low-intensive monitoring of progress was compared to an experimental condition where CBT was combined with a high-intensive form of feedback.
METHOD


Data of 368 outpatients (57.9% female, mean age 41.4 years, SD = 12.2) in secondary care were analyzed using multilevel analyses. Treatment duration was assessed with the number of sessions clients received. Symptom reduction was measured with the Symptom Checklist Revised. Possible moderators of the effect of intensive progress feedback on outcome were explored.
RESULTS


Clients achieved the same amount of symptom reduction in significantly fewer sessions in the high-intensive feedback condition. Additionally, dropout was significantly lower in the high-intensive feedback condition. Post hoc analyses assessing clients' diagnoses as a possible moderator showed that clients with personality disorders (mainly Cluster C) achieved more symptom reduction in fewer sessions when high-intensity feedback was provided. Also, a high degree of implementation within the experimental condition was associated with fewer treatment sessions.
CONCLUSION


In sum, the use of high-intensive client feedback reduced treatment duration and reduced dropout of CBT. Thus, feedback-informed CBTs seem to be a promising adaptation of conventional CBT. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Post hoc analyses assessing clients' diagnoses as a possible moderator showed that clients with personality disorders (mainly Cluster C) achieved more symptom reduction in fewer sessions when high-intensity feedback was provided.,"['Data of 368 outpatients (57.9% female, mean age 41.4 years, SD = 12.2) in secondary care']",['feedback-informed cognitive behavioral therapy'],"['symptom reduction', 'treatment outcome', 'Symptom reduction']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",368.0,0.0328832,Post hoc analyses assessing clients' diagnoses as a possible moderator showed that clients with personality disorders (mainly Cluster C) achieved more symptom reduction in fewer sessions when high-intensity feedback was provided.,"[{'ForeName': 'Pauline D', 'Initials': 'PD', 'LastName': 'Janse', 'Affiliation': 'Pro Persona Research.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Jong', 'Affiliation': 'Institute of Psychology, Leiden University.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Veerkamp', 'Affiliation': 'HSK Groep.'}, {'ForeName': 'Maarten K', 'Initials': 'MK', 'LastName': 'van Dijk', 'Affiliation': 'Dimence.'}, {'ForeName': 'Giel J M', 'Initials': 'GJM', 'LastName': 'Hutschemaekers', 'Affiliation': 'Pro Persona Research.'}, {'ForeName': 'Marc J P M', 'Initials': 'MJPM', 'LastName': 'Verbraak', 'Affiliation': 'Pro Persona Research.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000549']
2327,32658497,Treatment effects on pain catastrophizing and cutaneous allodynia symptoms in women with migraine and overweight/obesity.,"OBJECTIVE


Pain catastrophizing and cutaneous allodynia represent two risk factors for greater headache-related disability. Yet, there is limited knowledge of the extent to which these risk factors are modifiable and whether nonpharmacological treatment-related changes are associated with migraine improvements. Using data from the Women's Health and Migraine (WHAM) study, a randomized controlled trial that compared effects of behavioral weight loss (BWL) and migraine education (ME) in women with migraine and overweight/obesity, we tested whether: (a) BWL versus ME produced greater changes in pain catastrophizing and allodynia from baseline across posttreatment and follow-up time points, and (b) whether these improvements were associated with improvements in headache disability.
METHOD


Women ( N  = 110) were randomly assigned to 16 weeks of either BWL or ME and assessed at baseline, posttreatment, and follow up (32 weeks). Multilevel mixed effects modeling tested: (a) for between-groups differences in pain catastrophizing and allodynia changes over time, and (b) associations of changes in pain catastrophizing and allodynia with changes in headache disability, adjusting for migraine severity and weight loss.
RESULTS


Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions. Reductions in pain catastrophizing and cutaneous allodynia were associated with significant reductions in headache disability, even when controlling for intervention-related improvements in migraine and weight loss.
CONCLUSION


Pain catastrophizing and allodynia are not only reduced after nonpharmacologic treatments for migraine, but greater improvements are associated with greater reductions in headache-related disability, independent of migraine severity. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions.","['women with migraine and overweight/obesity', 'Women ( N  = 110']","['BWL or ME', 'behavioral weight loss (BWL) and migraine education (ME']","['pain catastrophizing and cutaneous allodynia symptoms', 'headache-related disability', 'pain catastrophizing and allodynia changes over time, and (b) associations of changes in pain catastrophizing and allodynia with changes in headache disability, adjusting for migraine severity and weight loss', 'headache disability', 'pain catastrophizing and cutaneous allodynia', 'pain catastrophizing and allodynia', 'migraine and weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1274924', 'cui_str': 'Cutaneous allodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",110.0,0.102198,"Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions.","[{'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Kibbey', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jelena M', 'Initials': 'JM', 'LastName': 'Pavlovic', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Kristine J', 'Initials': 'KJ', 'LastName': 'Steffen', 'Affiliation': 'School of Pharmacy.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000920']
2328,32658498,Interventions supporting cardiac rehabilitation completion: Process evaluation investigating theory-based mechanisms of action.,"OBJECTIVE


A randomized trial informed by the Health Action Process Approach evaluated interventions to improve cardiac rehabilitation completion following myocardial infarction. We investigated indirect effects of the interventions on completion via targeted constructs.
METHODS


In this theory-based process evaluation, participants in all 3 trial arms (usual care; mailouts; mailouts plus telephone support) completed a questionnaire 12 months after their myocardial infarction assessing intention, goal priority, outcome expectancies, risk perception, self-efficacy, social support, action planning, and coping planning. Consecutive sampling was used until the target sample size (167 per trial arm) was met. Cardiac rehabilitation completion was self-reported at the same time point. We used multiple regression mediation models to explore indirect effects.
RESULTS


In total, 594 participants completed the cardiac rehabilitation questionnaire; 588 were analyzed (6 excluded due to missing data). For mailouts alone, there were no significant indirect effects. There were small indirect effects of mailouts plus telephone support on intention via goal priority, outcome expectancies, and self-efficacy, with a negative effect via severity risk perception. There were also small indirect effects on cardiac rehabilitation completion via self-efficacy and action planning.
CONCLUSIONS


Findings help explain the trial results, suggesting that mailouts plus telephone support increased the likelihood of completing cardiac rehabilitation by enhancing self-efficacy and action planning, and increased intention by enhancing goal priority, self-efficacy, and outcome expectancies, with an unintended consequence of a negative effect via risk perceptions. Conducting theory-based process evaluations alongside trials of behavior change interventions can clarify mechanisms of action, which can inform efforts to refine interventions and to replicate and generalize findings to other jurisdictions. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"There were small indirect effects of mailouts plus telephone support on intention via goal priority, outcome expectancies, and self-efficacy, with a negative effect via severity risk perception.","['myocardial infarction', '594 participants completed the cardiac rehabilitation questionnaire; 588 were analyzed (6 excluded due to missing data']",[],"['outcome expectancies, risk perception, self-efficacy, social support, action planning, and coping planning', 'intention via goal priority, outcome expectancies, and self-efficacy']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",[],"[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}]",594.0,0.0533354,"There were small indirect effects of mailouts plus telephone support on intention via goal priority, outcome expectancies, and self-efficacy, with a negative effect via severity risk perception.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Centre for Implementation Research.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Women's College Research Institute.""}, {'ForeName': 'J-D', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Division of Cardiology.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Centre for Implementation Research.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': ""Women's College Research Institute.""}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bouck', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care.""}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': 'School of Kinesiology and Health Science.'}, {'ForeName': 'Madhu K', 'Initials': 'MK', 'LastName': 'Natarajan', 'Affiliation': 'Division of Cardiology.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Centre for Implementation Research.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'Centre for Implementation Research.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000958']
2329,32648409,"Use of biophysical treatment for the management of mild anxiety, depression and stress: a randomized controlled trial.",,2020,,"['mild anxiety, depression and stress']",['biophysical treatment'],[],"[{'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0959965,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Foletti', 'Affiliation': 'Clinical Biophysics International Research Group, Lugano, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Baron', 'Affiliation': 'Clinical Biophysics International Research Group, Lugano, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Francone', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Malandrone', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ostacoli', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carletto', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}]",Journal of biological regulators and homeostatic agents,['10.23812/20-132-L-57']
2330,32648790,Changes in inflammatory biomarkers are related to the antidepressant effects of Ayahuasca.,"BACKGROUND


Ayahuasca is a traditional Amazon brew and its potential antidepressant properties have recently been explored in scientific settings. We conducted a double-blind placebo-controlled trial of ayahuasca with treatment-resistant depression patients ( n  = 28) and healthy controls ( n  = 45).
AIMS


We are evaluating the blood inflammatory biomarkers: C-reactive protein and interleukin 6, as a potential consequence of ayahuasca intake and their correlation with serum cortisol and brain-derived neurotrophic factor levels. Blood samples were collected at pre-treatment and 48 hours after substance ingestion to assess the concentration of inflammatory biomarkers, together with administration of the Montgomery-Åsberg Depression Rating Scale.
RESULTS


At pre-treatment, patients showed higher C-reactive protein levels than healthy controls and a significant negative correlation between C-reactive protein and serum cortisol levels was revealed ( rho  = -0.40,  n  = 14). C-reactive protein in those patients was not correlated with Montgomery-Åsberg Depression Rating Scale scores. We observed a significant reduction of C-reactive protein levels across time in both patients and controls treated with ayahuasca, but not with placebo. Patients treated with ayahuasca showed a significant correlation ( rho  = + 0.57) between larger reductions of C-reactive protein and lower depressive symptoms at 48 hours after substance ingestion (Montgomery-Åsberg Depression Rating Scale). No significant result with respect to interleukin 6 and brain-derived neurotrophic factor was found. Furthermore, these biomarkers did not predict the antidepressant response or remission rates observed.
CONCLUSIONS


These findings enhance the understanding of the biological mechanisms behind the observed antidepressant effects of ayahuasca and encourage further clinical trials in adults with depression.",2020,"We observed a significant reduction of C-reactive protein levels across time in both patients and controls treated with ayahuasca, but not with placebo.","['adults with depression', 'with treatment-resistant depression patients ( n  = 28) and healthy controls ( n  = 45']","['ayahuasca', 'placebo']","['C-reactive protein and lower depressive symptoms', 'C-reactive protein and serum cortisol levels', 'Blood samples', 'antidepressant response or remission rates', 'interleukin 6 and brain-derived neurotrophic factor', 'C-reactive protein', 'C-reactive protein levels', 'Montgomery-Åsberg Depression Rating Scale scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0309995,"We observed a significant reduction of C-reactive protein levels across time in both patients and controls treated with ayahuasca, but not with placebo.","[{'ForeName': 'Nicole Leite', 'Initials': 'NL', 'LastName': 'Galvão-Coelho', 'Affiliation': 'Department of Physiology and Behavior, Laboratory of Hormone Measurement, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Ana Cecília', 'Initials': 'AC', 'LastName': 'de Menezes Galvão', 'Affiliation': 'Department of Physiology and Behavior, Laboratory of Hormone Measurement, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Raíssa Nóbrega', 'Initials': 'RN', 'LastName': 'de Almeida', 'Affiliation': 'Department of Physiology and Behavior, Laboratory of Hormone Measurement, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Palhano-Fontes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Campos Braga', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lobão Soares', 'Affiliation': 'National Science and Technology Institute for Translational Medicine, Natal, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Maia-de-Oliveira', 'Affiliation': 'National Science and Technology Institute for Translational Medicine, Natal, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Perkins', 'Affiliation': 'School of Social and Political Science, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Westmead, Australia.'}, {'ForeName': 'Draulio Barros', 'Initials': 'DB', 'LastName': 'de Araujo', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120936486']
2331,32644890,Reduction in Bacterial Loading using Papacarie and Carisolv as an Irrigant in Pulpectomized Primary Molars - A Preliminary Report.,"Objective:  The aim of the present study was to evaluate the reduction in bacterial loading using Papacarie and Carisolv as an irrigating solution in pulpectomized primary molars.  Study design:  A controlled, randomized clinical trial involving 120 necrotic canals from both genders between 3 and 7 years old children were included, 30 irrigated with Papacarie [ group I], Carisolv [ group II], 1% NaOCl gel [ group III] and 1% Na0Cl solution [group IV ] each; in all cases, 2 microbiological samples from within the canals were taken with sterile paper points, the first after the canal opening and before the first irrigation, and the second after instrumentation and final irrigation, before obturation. All samples were evaluated by Agar plate method.  Results:  The results were statistically analyzed by ANOVA. After analyzing samples before and after irrigation in all the groups, a strong significant decrease in bacterial load [ p = < 0.001 ] was found with Papacarie and Carisolv.  Conclusion:  Papacarie and Carisolv can be suggested as an alternative irrigant for pulpectomy of necrotic teeth.",2020,"After analyzing samples before and after irrigation in all the groups, a strong significant decrease in bacterial load [ p = < 0.001 ] was found with Papacarie and Carisolv.  ","['pulpectomized primary molars', '120 necrotic canals from both genders between 3 and 7 years old children']","['Papacarie [ group I], Carisolv [ group II], 1% NaOCl gel [ group III] and 1% Na0Cl solution']",['bacterial load'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1703313', 'cui_str': 'Papacarie'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0769128', 'cui_str': 'Carisolv'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C2936404', 'cui_str': 'Bacterial Load'}]",120.0,0.0243677,"After analyzing samples before and after irrigation in all the groups, a strong significant decrease in bacterial load [ p = < 0.001 ] was found with Papacarie and Carisolv.  ","[{'ForeName': 'Viral P', 'Initials': 'VP', 'LastName': 'Maru', 'Affiliation': ''}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Padawe', 'Affiliation': ''}, {'ForeName': 'Vandana Pandey', 'Initials': 'VP', 'LastName': 'Tripathi', 'Affiliation': ''}, {'ForeName': 'Vilas', 'Initials': 'V', 'LastName': 'Takate', 'Affiliation': ''}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Dighe', 'Affiliation': ''}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Vishwanath Dalvi', 'Affiliation': ''}]",The Journal of clinical pediatric dentistry,['10.17796/1053-4625-44.3.7']
2332,32644894,Efficacy of GC Gold Label 9 and GC Miracle Mix ®  Restorations using Atraumatic Restorative Treatment (ART) in Rural Settings: A Randomized Controlled Trial.,"Objectives:  This study compared the longevity of high strength posterior glass ionomer and metal-reinforced glass ionomer using ART in rural settings within an 18-month observation period.  Study Design:  A nonblinded parallel design randomized controlled trial was conducted among children who attended dental outreach programs in a rural area of Southern India. Atraumatic Restorative Treatment (ART) was performed in 92 permanent posterior teeth with either high strength posterior glass ionomer or metal-reinforced glass ionomer restorations. The allocation ratio was 1:1. Restorations were evaluated at 1, 6, 12 and 18 months after placement.  Results:  The success rate of metal-reinforced glass ionomer restorations was 100%, 95.4%, 90.4% and 87.2% as compared to high strength posterior glass ionomer whose success rates were 100%, 93%, 85% and 61.8% at the four follow ups respectively. There was a statistically significant difference between the success rate of the two materials at the end of 18 months with the metal-reinforced glass ionomer restorations having a higher success rate (p=0.015). Conclusions : Although the clinical performance of both materials were largely similar, the metal-reinforced glass ionomer restorations had a higher success rate than the conventional GIC at the end of 18 months of follow-up.",2020,There was a statistically significant difference between the success rate of the two materials at the end of 18 months with the metal-reinforced glass ionomer restorations having a higher success rate (p=0.015).,"['92 permanent posterior teeth with either high strength posterior glass ionomer or metal-reinforced glass ionomer restorations', 'Rural Settings', 'children who attended dental outreach programs in a rural area of Southern India', 'rural settings within an 18-month observation period']",['Atraumatic Restorative Treatment (ART'],"['success rates', 'success rate of metal-reinforced glass ionomer restorations', 'success rate']","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",92.0,0.167449,There was a statistically significant difference between the success rate of the two materials at the end of 18 months with the metal-reinforced glass ionomer restorations having a higher success rate (p=0.015).,"[{'ForeName': 'Valerie Gloria', 'Initials': 'VG', 'LastName': ""D'Costa"", 'Affiliation': ''}, {'ForeName': 'Deepak Kumar', 'Initials': 'DK', 'LastName': 'Singhal', 'Affiliation': ''}, {'ForeName': 'Shashidhar', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ''}]",The Journal of clinical pediatric dentistry,['10.17796/1053-4625-44.3.3']
2333,32645251,"Topical odorant application of the specific olfactory receptor OR2AT4 agonist, Sandalore ®  , improves telogen effluvium-associated parameters.","OBJECTIVE


Human hair follicles (HFs) express the olfactory receptor OR2AT4, which is selectively stimulated by the synthetic sandalwood-like odorant, Sandalore ®  . In organ-cultured, human scalp HFs, Sandalore ®  prolongs anagen, and suppresses apoptosis by up-regulating intra-follicular IGF-1 mediated signalling. The objective of this study is to demonstrate whether effects of Sandalore ®  observed ex vivo translate into a clinically relevant effect in patients with telogen effluvium.
METHODS


In a randomized, double-blinded, placebo-controlled, clinical trial 60 female volunteers (18-65 years) affected by telogen effluvium received over a period of 24 weeks treatment with either 1% Sandalore ®  solution (n=30) or placebo (n=30). The study read-out parameters were the degree of hair shedding, hair volume, terminal/vellus hair ratio, anagen/catagen-telogen ratio, and patient self-assessment.
RESULTS


Sandalore ®  1% ameliorated clinical signs of telogen effluvium, namely it reduced hair shedding, and increased hair volume and the percentage of anagen HFs, the latter two parameters significantly more than placebo, when changes were calculated to baseline. Sandalore ®  also increased the ratio of terminal/vellus hairs at week 8. Most of the anti-hair shedding effects were seen after 8 weeks and maintained at week 24. Patient questionnaire showed that verum group patients were more satisfied than the placebo group in regards to the overall results.
CONCLUSION


This clinical trial supports previous findings of anagen-prolonging effects of Sandalore ®  ex vivo with similar results now reproduced in clinical practice. It also provides evidence that a topically applied cosmetic odorant acting through HF olfactory receptors can be a therapeutic alternative to treat hair loss disorders characterized by excessive hair shedding such as telogen effluvium.",2020,"RESULTS


Sandalore ®  1% ameliorated clinical signs of telogen effluvium, namely it reduced hair shedding, and increased hair volume and the percentage of anagen HFs, the latter two parameters significantly more than placebo, when changes were calculated to baseline.","['patients with telogen effluvium', '60 female volunteers (18-65 years) affected by telogen effluvium received over a period of 24 weeks treatment with either']","['1% Sandalore ®  solution', 'placebo']","['hair volume and the percentage of anagen HFs', 'degree of hair shedding, hair volume, terminal/vellus hair ratio, anagen/catagen-telogen ratio, and patient self-assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263518', 'cui_str': 'Telogen effluvium'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4742605', 'cui_str': 'Sandalore'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0221976', 'cui_str': 'Anagen hair'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221959', 'cui_str': 'Structure of vellus hair'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}]",60.0,0.203102,"RESULTS


Sandalore ®  1% ameliorated clinical signs of telogen effluvium, namely it reduced hair shedding, and increased hair volume and the percentage of anagen HFs, the latter two parameters significantly more than placebo, when changes were calculated to baseline.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Jimenez', 'Affiliation': 'Mediteknia Clinic and Monasterium Clinical Hair Trial Unit, Las Palmas, Gran Canaria, Spain.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'López', 'Affiliation': 'Mediteknia Clinic and Monasterium Clinical Hair Trial Unit, Las Palmas, Gran Canaria, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bertolini', 'Affiliation': 'Monasterium Laboratory, Skin and Hair Research Solutions GmbH, Muenster, Germany.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'Universidad Fernando Pessoa Canarias, Gran Canaria, Spain.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Chéret', 'Affiliation': 'Monasterium Laboratory, Skin and Hair Research Solutions GmbH, Muenster, Germany.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Westgate', 'Affiliation': 'Gill Westgate Consultancy Ltd, Stevington, Bedford, UK.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Giuliani Pharma S.p.A, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marzani', 'Affiliation': 'Giuliani Pharma S.p.A, Milan, Italy.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Paus', 'Affiliation': 'Monasterium Laboratory, Skin and Hair Research Solutions GmbH, Muenster, Germany.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13608']
2334,32645310,A Randomized Controlled Trial Comparing Subconjunctival Injection to Direct Scleral Application of Mitomycin C in Trabeculectomy.,"PURPOSE


To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy.
DESIGN


Prospective, randomized, interventional study.
PARTICIPANTS


Subjects with medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy is indicated.
METHODS


SETTING: Single clinical practice in an academic setting Patient or Study Population: Patients older than 18 years with medically uncontrolled glaucoma and no previous history of incisional glaucoma surgery Intervention or Observation Procedure(s): Subjects were randomized to MMC delivered by preoperative subconjunctival injection or intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at one day, one week, six weeks, three months, and six months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed.
MAIN OUTCOME MEASURE(S)


Proportion of subjects demonstrating IOP less than 21 mm Hg and 30% or more reduction in IOP from baseline. Secondary outcome measures included the number of IOP lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates.
RESULTS


Participants (n=100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
CONCLUSIONS


Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.",2020,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","['Participants (n=100', 'academic setting Patient or Study Population: Patients older than 18 years with medically uncontrolled glaucoma and no previous history of incisional glaucoma surgery Intervention or Observation Procedure(s): Subjects', 'Trabeculectomy', 'Subjects with medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy is indicated']","['Subconjunctival Injection', 'MMC delivery (subconjunctival injection and direct scleral application', 'mitomycin C (MMC', 'Subconjunctival 5-fluorouracil injections', 'preoperative subconjunctival injection or intraoperative direct scleral application using surgical sponges during trabeculectomy', 'Mitomycin C', 'MMC']","['number of glaucoma medications', 'bleb height', 'bleb vascularity', 'bleb extension', 'number of IOP lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates', 'mean IOP', 'surgical success', 'surgical outcomes and bleb morphologies']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0197180', 'cui_str': 'Subconjunctival injection'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038937', 'cui_str': 'Surgical sponge'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",100.0,0.153502,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","[{'ForeName': 'Jiun L', 'Initials': 'JL', 'LastName': 'Do', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Xu', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Camp', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ngai', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Long', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Moghimi', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Diya', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Welsbie', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Weinreb', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA. Electronic address: rweinreb@health.ucsd.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.002']
2335,32646369,Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients.,"BACKGROUND


Periampullary adenocarcinoma is a major clinical problem in high-risk patients including FAP population. A recent modification for visualizing the ampulla of Vater (AV) involves attaching a cap to the tip of the forward-viewing endoscope. Our aim was to compare the rates of complete visualization of AV using this cap-assisted endoscopy (CAE) approach to standard forward-viewing endoscopy (FVE). We also determined: (i) the rates of complications and additional sedation; (ii) the mean time required for duodenal examination; and (iii) the reproducibility among endoscopists performing this procedure.
METHODS


We performed esophagogastroduodenoscopy for AV visualization in 102 > 18 years old using FVE followed by CAE. Video recordings were blinded and randomly selected for independent expert endoscopic evaluation.
RESULTS


The complete visualization rate for AV was higher in CAE (97.0%) compared to FVE (51.0%) (p <  0.001). The additional doses of fentanyl, midazolam, and propofol required for CAE were 0.05, 1.9 and 36.3 mg. in 0.9, 24.5, and 77.5% patients, respectively. The mean time of duodenal examination for AV visualization was lower on CAE compared to FVE (1.41 vs. 1.95 min, p <  0.001). Scopolamine was used in 34 FVE and 24 CAE, with no association to AV complete visualization rates (p = 0.30 and p = 0.14). Three more ampullary adenomas were detected using CAE compared to FVE. Cap displacement occurred in one patient, and there was no observed adverse effect of the additional sedatives used. Kappa values for agreement between endoscopists ranged from 0.60 to 0.85.
CONCLUSIONS


CAE is feasible, reproducible and safe, with a higher success rate for complete visualization compared to FVE.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT02867826 , 16 August 2016.",2020,The complete visualization rate for AV was higher in CAE (97.0%) compared to FVE (51.0%) (p <  0.001).,"['high-risk patients', '102\u2009>\u200918\u2009years old using FVE followed by CAE', 'high-risk patients including FAP population']","['cap-assisted endoscopy (CAE) approach to standard forward-viewing endoscopy (FVE', 'fentanyl, midazolam, and propofol', 'Cap-assisted endoscopy', 'Scopolamine']","['rates of complications and additional sedation; (ii) the mean time required for duodenal examination', 'Cap displacement', 'mean time of duodenal examination for AV visualization', 'AV complete visualization rates', 'complete visualization rate for AV', 'Kappa values']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0042425', 'cui_str': 'Structure of ampulla of Vater'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.076049,The complete visualization rate for AV was higher in CAE (97.0%) compared to FVE (51.0%) (p <  0.001).,"[{'ForeName': 'Leonardo Correa', 'Initials': 'LC', 'LastName': 'Silva', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Rondinelle Martins', 'Initials': 'RM', 'LastName': 'Arruda', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Paula Fortuci Resende', 'Initials': 'PFR', 'LastName': 'Botelho', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Leonardo Nogueira', 'Initials': 'LN', 'LastName': 'Taveira', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Kelly Menezio', 'Initials': 'KM', 'LastName': 'Giardina', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Biostatistics, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dias', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Cleyton Zanardo', 'Initials': 'CZ', 'LastName': 'Oliveira', 'Affiliation': 'Department of Biostatistics, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Fava', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Denise Peixoto', 'Initials': 'DP', 'LastName': 'Guimarães', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil. guimaraes.dp@gmail.com.'}]",BMC gastroenterology,['10.1186/s12876-020-01361-5']
2336,32646379,90 days impacts of remote ischemic preconditioning on patients undergoing open total aortic arch replacement: a post-hoc analysis of previous trial.,"BACKGROUND


In the previous randomized controlled trial by our research group, we evaluated the effect of remote ischemic preconditioning (RIPC) in 130 patients (65 per arm) on acute kidney injury (AKI) within 7 days of open total aortic arch replacement. Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III). However, the long-term effect of RIPC in patients undergoing open total aortic arch replacement is unclear.
METHODS


This study was a post-hoc analysis. We aimed to assess the roles of RIPC in major adverse kidney events (MAKE), defined as consisting persistent renal dysfunction, renal replacement therapy and mortality, within 90 days after surgery in patients receiving open total aortic arch replacement.
RESULTS


In this 90-day follow-up study, data were available for all study participants. We found that RIPC failed to improve the presence of MAKE within 90 days after surgery (RIPC: 7 of 65[10.8%]) vs sham: 15 of 65[23.1%]; P = 0.061). In those patients who developed AKI after surgery, we found that the rate of MAKE within 90 days after surgery differed between the RIPC group and the sham group (RIPC: 4 of 36[11.2%]; sham: 14 of 48[29.2%]; P = 0.046).
CONCLUSIONS


At 90 days after open total aortic arch replacement, we failed to find a difference between the renoprotective effects of RIPC and sham treatment. The effectiveness or ineffectiveness of RIPC should be further investigated in a large randomized sham-controlled trial.
TRIAL REGISTRATION


This study was approved by the Ethics Committee of Fuwai Hospital (No. 2016-835) and our previous study was registered at clinicaltrials.gov before patient enrollment ( NCT03141385 ; principal investigator: G.W.; date of registration: March 5, 2017).",2020,"Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III).","['130 patients (65 per arm) on acute kidney injury (AKI) within 7\u2009days of open total aortic arch replacement', 'patients undergoing open total aortic arch replacement', 'patients receiving open total aortic arch replacement']","['remote ischemic preconditioning', 'RIPC', 'remote ischemic preconditioning (RIPC']",['postoperative AKI'],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3697092', 'cui_str': 'Aortic arch replacement'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",,0.491524,"Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III).","[{'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Guyan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China. guyanwang2006@163.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Congya', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Xiying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Guiyu', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'Department of Anesthesiology, Beijng Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang, Dongcheng District, Beijing, 100730, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01085-9']
2337,32646424,Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial.,"BACKGROUND


Assessments of lung function, exacerbations and health status are common measures of chronic obstructive pulmonary disease (COPD) progression and treatment response in clinical trials. We hypothesised that a composite endpoint could more holistically assess clinically important deterioration (CID) in a COPD clinical trial setting.
METHODS


A composite endpoint was tested in a post hoc analysis of 5652 patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2-4 COPD from the 4-year UPLIFT study. Patients received tiotropium 18 μg or placebo.
RESULTS


The composite endpoint included time to first confirmed decrease in trough forced expiratory volume in 1 s (FEV 1 ) ≥100 mL, confirmed increase in St. George's Respiratory Questionnaire (SGRQ) total score ≥ 4 units, or moderate/severe exacerbation. Most patients (> 80%) experienced CID, with similar incidence among GOLD subgroups. Most confirmed trough FEV 1  (74.6-81.6%) and SGRQ (72.3-78.1%) deteriorations were sustained across the study and in all GOLD subgroups. Patients with CID more frequently experienced subsequent exacerbation (hazard ratio [HR] 1.79; 95% confidence interval [CI] 1.67, 1.92) or death (HR 1.21; 95% CI 1.06, 1.39) by Month 6. CID was responsive to bronchodilator treatment.
CONCLUSIONS


Composite endpoints provide additional information on COPD progression and treatment effects in clinical trials.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00144339 .",2020,"Patients with CID more frequently experienced subsequent exacerbation (hazard ratio [HR] 1.79; 95% confidence interval [CI] 1.67, 1.92) or death (HR 1.21; 95% CI 1.06, 1.39) by Month 6.",['5652 patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2-4 COPD from the 4-year UPLIFT study'],['tiotropium 18\u2009μg or placebo'],"['SGRQ', ""trough forced expiratory volume in 1\u2009s (FEV 1 ) ≥100\u2009mL, confirmed increase in St. George's Respiratory Questionnaire (SGRQ) total score\u2009≥\u20094\u2009units, or moderate/severe exacerbation"", 'COPD progression', 'death', 'subsequent exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",5652.0,0.646632,"Patients with CID more frequently experienced subsequent exacerbation (hazard ratio [HR] 1.79; 95% confidence interval [CI] 1.67, 1.92) or death (HR 1.21; 95% CI 1.06, 1.39) by Month 6.","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'Member of the German Center for Lung Research (DZL), LungClinic Grosshansdorf, Wöhrendamm 80, 22927, Grosshansdorf, Germany. k.f.rabe@lungenclinic.de.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan Health System, Ann Arbor, MI, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miravitlles', 'Affiliation': ""Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Ciber de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit (MEU), University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grönke', 'Affiliation': 'Clinical Development, CSL Behring GmbH, Marburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Voß', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Internal Medicine, Weill Cornell School of Medicine, New York, NY, USA.'}]",Respiratory research,['10.1186/s12931-020-01431-y']
2338,32646428,"Daily consumption of one teaspoon of trehalose can help maintain glucose homeostasis: a double-blind, randomized controlled trial conducted in healthy volunteers.","BACKGROUND


Trehalose is a natural disaccharide that is widely distributed. A previous study has shown that daily consumption of 10 g of trehalose improves glucose tolerance in individuals with signs of metabolic syndrome. In the present study, we determined whether a lower dose (3.3 g/day) of trehalose improves glucose tolerance in healthy Japanese volunteers.
METHODS


This was a randomized, double-blind, placebo-controlled study of healthy Japanese participants (n = 50). Each consumed 3.3 g of trehalose (n = 25) or sucrose (n = 25) daily for 78 days. Their body compositions were assessed following 0, 4, 8, and 12 weeks; and serum biochemical parameters were assayed and oral 75-g glucose tolerance tests were performed at baseline and after 12 weeks.
RESULTS


There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups. However, whereas after 12 weeks of sucrose consumption, the plasma glucose concentration 2 h after a 75-g glucose load was significantly higher than the fasting concentration, after 12 weeks of trehalose consumption the fasting and 2-h plasma glucose concentrations were similar. Furthermore, an analysis of the participants with relatively high postprandial blood glucose showed that the plasma glucose concentration 2 h after a 75-g glucose load was significantly lower in the trehalose group than in the sucrose group.
CONCLUSIONS


Our findings suggest that trehalose helps lower postprandial blood glucose in healthy humans with higher postprandial glucose levels within the normal range, and may therefore contribute to the prevention of pathologies that are predisposed to by postprandial hyperglycemia,, even if the daily intake of trehalose is only 3.3 g, an amount that is easily incorporated into a meal.
TRIAL REGISTRATION


UMIN, UMIN000033536 . Registered 27 July 2018.",2020,"There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups.","['healthy Japanese participants (n\u2009=\u200950', 'healthy humans', 'healthy volunteers', 'individuals with signs of metabolic syndrome', 'healthy Japanese volunteers']","['trehalose', 'trehalose (n\u2009=\u200925) or sucrose', 'placebo']","['glucose tolerance', 'postprandial blood glucose', 'serum biochemical parameters', 'plasma glucose concentration', 'fasting and 2-h plasma glucose concentrations', 'body composition and serum biochemistry']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0040815', 'cui_str': 'Trehalose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}]",,0.132141,"There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups.","[{'ForeName': 'Chiyo', 'Initials': 'C', 'LastName': 'Yoshizane', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan. chiyo.yoshizane@hb.nagase.co.jp.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Mizote', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Arai', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Norie', 'Initials': 'N', 'LastName': 'Arai', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Ogawa', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Mitsuzumi', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Ushio', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}]",Nutrition journal,['10.1186/s12937-020-00586-0']
2339,32650818,Test and treat COVID 65 plus - Hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of older patients with COVID19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The aim of this trial is to identify the effect of ambulatory treatment in early COVID-19 disease with hydroxychloroquine on the rate of hospitalization or death in older patients above the age of 64.
TRIAL DESIGN


Parallel, 2:1 randomization, double blind, placebo-controlled, multi-center trial.
PARTICIPANTS


Male and female patients above the age of 64 (i.e. ≥65 years of age) with COVID-19 diagnosis confirmed by SARS-CoV2 positive throat swab (PCR). Patients can only be included within 3 days of symptom onset in ambulatory care if they consent to the study procedure and are able to adhere to the study visit schedule and protocol requirements (including telephone visits concerning symptoms and side effects). Severity of disease at inclusion is mild to moderate defined as not requiring hospital admission: SpO2 >94%, respiratory rate <20, mental state alert, no signs of septic shock. Cardiac risk is minimised by requiring a Tisdale score ≤ 6. Patients are recruited in the two german cities of Ulm and Tübingen in various ambulatory care settings.
INTERVENTION AND COMPARATOR


Each patient will be given a first dose of 600 mg Hydroxychloroquine or the equivalent number of placebo capsules (3 capsules) at the day of inclusion. From the 2 nd  day on, each patient will get 200 mg or the equivalent number of placebo capsules twice a day (400mg/day) until day 7 (6 more does of 400 mg); a cumulative dose of 3 g.
MAIN OUTCOMES


Rate of hospitalization or death at day 7 after study inclusion RANDOMISATION: All consenting adult patients having confirmed COVID-19 are randomly and blindly allocated in a 2:1 ratio to either IMP or placebo. The biostatistical center produced a randomization list (block randomization) with varying block length and stratified for the study center. This list is provided for packaging to the pharmaceutical unit which is providing encapsulated placebo and IMP. Only the pharmaceutical unit is aware of group allocation according to the randomization list.
BLINDING (MASKING)


Patients and investigators, as well as treating physicians are blinded to the treatment- allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


In the first stage of an adaptive design 120 patients in a 2:1 ration: 72 Verum and 36 Placebo, plus an increase for 10% drop outs. After interim analysis, the total sample size will be calculated based on the effect seen in the first stage. Total sample size is estimated approximately n = 300-400 patients.
TRIAL STATUS


Protocol version number: V3, 19.05.2020 Recruitment not yet started but is anticipated to begin by June 2020 and be complete by December 2020 TRIAL REGISTRATION: ClinicalTrials.gov: NCT04351516 , date: 17 April 2020 EudraCT: 2020-001482-37, date: 30 March 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The biostatistical center produced a randomization list (block randomization) with varying block length and stratified for the study center.,"['Male and female patients above the age of 64 (i.e. ≥65 years of age) with COVID-19 diagnosis confirmed by SARS-CoV2 positive throat swab (PCR', 'Patients are recruited in the two german cities of Ulm and Tübingen in various ambulatory care settings', 'All consenting adult patients having confirmed COVID-19', 'older patients above the age of 64', 'Total sample size is estimated approximately n = 300-400 patients', 'older patients with COVID19']","['Placebo', 'hydroxychloroquine', 'IMP or placebo', 'Hydroxychloroquine', 'COVID 65 plus - Hydroxychloroquine versus placebo', 'placebo']","['rate of hospitalization or death', 'Rate of hospitalization or death']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0021533', 'cui_str': 'Inosine monophosphate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.656907,The biostatistical center produced a randomization list (block randomization) with varying block length and stratified for the study center.,"[{'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Göpel', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany. siri.goepel@med.uni-tuebingen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bethge', 'Affiliation': 'Department Internal Medicine 2, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biostatistics, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kreth', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Iftner', 'Affiliation': 'Department of Virology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Department of General Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Döbele', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Institute for Tropical Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kremsner', 'Affiliation': 'Institute for Tropical Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'Medical Clinic 1, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Medical Clinic 1, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bitzer', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Nisar', 'Initials': 'N', 'LastName': 'Malek', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}]",Trials,['10.1186/s13063-020-04556-z']
2340,32650886,Impact of a pain management program on nurses' knowledge and attitude toward pain in United Arab Emirates: Experimental-four Solomon group design.,"BACKGROUND


Lack of knowledge about pain is a common barrier to effective pain management. Educational pain management programs directed to health care professionals can improve knowledge and attitudes about pain. However, changing practice is more challenging, but can be achieved with more targeted educational interventions within the clinical setting.
OBJECTIVES


The main objective of this study was to examine which of four separate pain management educational designs improved nurses' knowledge and attitudes toward pain over time. Secondary objectives were to compare and contrast nurse's knowledge and attitudes toward pain before and after the educational intervention.
DESIGN


This randomized controlled trial using a four Solomon group design.
SETTING


This study took place in Dubai Hospital, Dubai Health Authority, in United Arab Emirates between January 2019-April 2019.
PARTICIPANTS


The sample consisted of 200 registered nurses who were randomly selected and assigned into four separate educational groups. Participants had at least one year of experience in Dubai hospital prior to data collection.
RESULTS


paired t-test has shown the experimental group scored significantly higher than the control group (p < 0.01). One-way ANOVA revealed significant post-test score differences between groups p < 0.001. A repeated measures ANOVA with a Greenhouse-Geisser correction determined that mean scores over three months was not statistically significant. Indicating that the level of knowledge did not change over time within any of the groups.
CONCLUSION AND RECOMMENDATIONS


The most important findings were the relatively low pre-test knowledge scores among staff nurses, and the significant improvement in knowledge for most test items following the educational intervention. Moreover, the level of knowledge and attitudes were maintained over three months. The pain management program proved to be effective in improving nurses' pain knowledge, attitudes, and assessment practices. Nurses in the experimental group increased their pain score significantly after the pain management program. Registration number: NETUBR.",2020,"RESULTS


paired t-test has shown the experimental group scored significantly higher than the control group (p < 0.01).","['Participants had at least one year of experience in Dubai hospital prior to data collection', 'Dubai Hospital, Dubai Health Authority, in United Arab Emirates between January 2019-April 2019', 'The sample consisted of 200 registered nurses who were randomly selected and assigned into four separate educational groups']",['pain management program'],"[""nurses' knowledge and attitude toward pain"", ""contrast nurse's knowledge and attitudes toward pain"", 'pain score', 'level of knowledge and attitudes', ""nurses' knowledge and attitudes toward pain over time""]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",200.0,0.0258756,"RESULTS


paired t-test has shown the experimental group scored significantly higher than the control group (p < 0.01).","[{'ForeName': 'Nezar Ahmed', 'Initials': 'NA', 'LastName': 'Salim', 'Affiliation': 'Dubai Health Authority, Education Department, Dubai Hospital, Dubai, United Arab Emirates; Amana Health Care Medical and Rehabilitation Hospital, Abu Dhabi, United Arab Emirates; Collaborative Science and Innovation, Clinical Nurse Specialist and Nurse Scientist, Billings Clinic, MT, USA. Electronic address: Nezar_dubai30@yahoo.com.'}, {'ForeName': 'Mohammed Ghassan', 'Initials': 'MG', 'LastName': 'Tuffaha', 'Affiliation': 'Dubai Health Authority, Education Department, Dubai Hospital, Dubai, United Arab Emirates; Amana Health Care Medical and Rehabilitation Hospital, Abu Dhabi, United Arab Emirates; Collaborative Science and Innovation, Clinical Nurse Specialist and Nurse Scientist, Billings Clinic, MT, USA.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Brant', 'Affiliation': 'Dubai Health Authority, Education Department, Dubai Hospital, Dubai, United Arab Emirates; Amana Health Care Medical and Rehabilitation Hospital, Abu Dhabi, United Arab Emirates; Collaborative Science and Innovation, Clinical Nurse Specialist and Nurse Scientist, Billings Clinic, MT, USA.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151314']
2341,32650887,Feasibility and acceptability of a self-managed exercise to rhythmic music intervention for ICU survivors.,"BACKGROUND


Post-ICU rehabilitation is a challenging clinical issue for patients discharged from an Intensive Care Unit (""ICU survivors""). Our exercise to rhythmic music intervention was designed to allow ICU survivors to self-manage their exercise by following a personalized, recorded exercise playlist.
AIM


Our study reports the feasibility and acceptability of an innovative music intervention among ICU survivors enrolled in a randomized controlled pilot study.
METHODS


ICU survivors, admitted in ICU for at least 5 days and cognitively intact, were randomly assigned to an exercise to rhythmic music group (n = 10) or an active control group (n = 10). Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability. Participants in the control group were provided a brochure with exercise instructions. After 5 days or at hospital discharge, participants completed an 8-item acceptability questionnaire and were interviewed. Content analysis was conducted.
RESULTS


18 Participants were included for final analysis. Participants were 61.8 ± 14.7 years old, predominantly male (66.7%), and Caucasian (55.6%). Results demonstrated feasibility, as the study team was able to meet the enrollment goal of 5-6 participants per month. Three themes related to general, physical, and psychosocial benefits were identified. Based on positive feedback, the exercise to rhythmic music intervention was deemed acceptable.
CONCLUSION


The exercise to rhythmic music intervention was feasible and acceptable, suggesting that clinical trials with larger sample sizes should investigate the effects of the intervention on outcomes among ICU survivors.",2020,Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability.,"['ICU survivors, admitted in ICU for at least 5\xa0days and cognitively intact', '14.7\xa0years old, predominantly male (66.7%), and Caucasian (55.6', 'ICU survivors', 'patients discharged from an Intensive Care Unit (""ICU survivors', '18 Participants were included for final analysis', 'Participants were 61.8\xa0±']","['brochure with exercise instructions', 'rhythmic music intervention', 'self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability', 'self-managed exercise to rhythmic music intervention', 'exercise to rhythmic music group (n\xa0=\xa010) or an active control group', 'innovative music intervention']","['8-item acceptability questionnaire', 'Feasibility and acceptability']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",18.0,0.0639096,Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability.,"[{'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'University of Miami, School of Nursing and Health Studies, United States of America. Electronic address: zxl667@miami.edu.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Munro', 'Affiliation': 'University of Miami, School of Nursing and Health Studies, United States of America.'}, {'ForeName': 'Tanira B D', 'Initials': 'TBD', 'LastName': 'Ferreira', 'Affiliation': 'University of Miami Hospital & Clinics, Department of Medicine, Division of Pulmonary Disease and Critical Care, Miami, FL, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clochesy', 'Affiliation': 'University of Miami, School of Nursing and Health Studies, United States of America.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Yip', 'Affiliation': 'University of Miami, Frost School of Music, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Sena Moore', 'Affiliation': 'University of Miami, Frost School of Music, United States of America.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kip', 'Affiliation': 'University of South Florida, College of Public Health, United States of America.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151315']
2342,32649708,Feasibility and acceptability of a milk and resistance exercise intervention to improve muscle function in community-dwelling older adults (MIlkMAN): Pilot study.,"BACKGROUND


Dietary protein supplementation combined with resistance exercise (RE) may counteract declines in muscle strength, mass, and function (sarcopenia), but the role of whole foods rich in protein, such as milk, is less well understood. In the MIlkMAN study, we aimed to examine the feasibility and acceptability of milk+RE as an intervention for muscle function in community-dwelling older adults, and provide exploratory pilot data for future substantive research in population at risk of sarcopenia.
METHODS


In a parallel groups design, 30 older adults (71.7±3.6 years; 12 women) were randomised into three groups: WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE. RE was performed twice-weekly over 6 weeks in a community gym, followed by the consumption of 500 ml of milk (~20 g protein) or carbohydrate drink immediately after exercise and a further 500 ml at home within the following 4-5 hours. The feasibility and acceptability of the study was determined by calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events.
RESULTS


The response rate was 49% (out of 400 invitations sent), and the recruitment rate was 73.2% (30 participants recruited out of 41 screened for eligibility). Twenty-nine participants completed the intervention-an attendance rate of 97.1%; 89.7% rated their experience as 'excellent'/very good'. Compliance with taking the drinks was 97.1% (WM), 98.3% (SM), and 95.0% (C); 93.1% rated their drink intake as 'easy'/'very easy' with no adverse effects. Collection of exploratory pilot data to inform future trials was successful. Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
CONCLUSIONS


This community-based milk+RE intervention was feasible and acceptable to older adults. The study successfully collected pilot data for future substantive research.",2020,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","['30 older adults (71.7±3.6 years; 12 women', 'older adults', 'community-dwelling older adults', '20', 'community-dwelling older adults (MIlkMAN']","['milk and resistance exercise intervention', 'milk+RE', 'carbohydrate drink', 'WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE', 'Dietary protein supplementation combined with resistance exercise (RE', 'milk+RE intervention']","['attendance rate', 'muscle function', 'Mean change in grip strength, 5-chair rises, and gait speed', ""calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events"", 'response rate', 'Feasibility and acceptability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0402554', 'cui_str': 'Milkman'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0398701,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","[{'ForeName': 'Antoneta', 'Initials': 'A', 'LastName': 'Granic', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hurst', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Lorelle', 'Initials': 'L', 'LastName': 'Dismore', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, Research and Development, North Tyneside General Hospital, North Shields, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Stevenson', 'Affiliation': 'Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Avan A', 'Initials': 'AA', 'LastName': 'Sayer', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Aspray', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0235952']
2343,32649717,Intranasal fentanyl spray versus intravenous opioids for the treatment of severe pain in patients with cancer in the emergency department setting: A randomized controlled trial.,"OBJECTIVE


Intranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting.
METHODS


We randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (≥7, scale: 0 ""none"" to 10 ""worst pain""). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group).
RESULTS


At T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (<pain relief) mean change in the IVH group. Finally, assuming all subjects in the IVH group had maximum pain at T0 and that T0 pain for the INF group remained unchanged from randomization, the lower bound of the 90% CL for mean pain decrease in the INF group extended 1.37 points below (<pain relief) mean decrease in the IVH group. Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
CONCLUSIONS


Two of three analyses supported non-inferiority of INF versus IVH, while one analysis was inconclusive. Compared to IVH, INF had the advantage of shorter time to administration.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02459964.",2020,"Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
","['cancer patients with severe pain in an emergency department (ED) setting', 'patients with cancer in the emergency department setting', '82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40']","['INF relative to IVH', 'Intranasal fentanyl spray versus intravenous opioids', 'Intranasal fentanyl (INF', 'hydromorphone (IVH']","['maximum pain at T0 and that T0 pain', 'T0 pain ratings', 'mean pain decrease', 'mean pain change', 'mean log-transformed pain ratings', '2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group', 'severe pain', 'pain change']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",82.0,0.173866,"Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Banala', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Osama K', 'Initials': 'OK', 'LastName': 'Khattab', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Valda D', 'Initials': 'VD', 'LastName': 'Page', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Carla L', 'Initials': 'CL', 'LastName': 'Warneke', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Knox H', 'Initials': 'KH', 'LastName': 'Todd', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Sai-Ching Jim', 'Initials': 'SJ', 'LastName': 'Yeung', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}]",PloS one,['10.1371/journal.pone.0235461']
2344,32649733,An exploratory Study of EEG Alpha Oscillation and Pupil Dilation in Hearing-Aid Users During Effortful listening to Continuous Speech.,"Individuals with hearing loss allocate cognitive resources to comprehend noisy speech in everyday life scenarios. Such a scenario could be when they are exposed to ongoing speech and need to sustain their attention for a rather long period of time, which requires listening effort. Two well-established physiological methods that have been found to be sensitive to identify changes in listening effort are pupillometry and electroencephalography (EEG). However, these measurements have been used mainly for momentary, evoked or episodic effort. The aim of this study was to investigate how sustained effort manifests in pupillometry and EEG, using continuous speech with varying signal-to-noise ratio (SNR). Eight hearing-aid users participated in this exploratory study and performed a continuous speech-in-noise task. The speech material consisted of 30-second continuous streams that were presented from loudspeakers to the right and left side of the listener (±30° azimuth) in the presence of 4-talker background noise (+180° azimuth). The participants were instructed to attend either to the right or left speaker and ignore the other in a randomized order with two different SNR conditions: 0 dB and -5 dB (the difference between the target and the competing talker). The effects of SNR on listening effort were explored objectively using pupillometry and EEG. The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition. This study demonstrates that both measures are sensitive to changes in SNR during continuous speech.",2020,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"['Eight hearing-aid users participated', 'Hearing-Aid Users', 'Individuals with hearing loss allocate cognitive resources']","['EEG Alpha Oscillation and Pupil Dilation', 'continuous speech-in-noise task', 'SNR', 'continuous speech with varying signal-to-noise ratio (SNR']",['mean pupil dilation and decreased EEG alpha power'],"[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0156161,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"[{'ForeName': 'Tirdad', 'Initials': 'T', 'LastName': 'Seifi Ala', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Graversen', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Wendt', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Alickovic', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Whitmer', 'Affiliation': 'Hearing Sciences-Scottish Section, Division of Clinical Neuroscience, University of Nottingham, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lunner', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}]",PloS one,['10.1371/journal.pone.0235782']
2345,32658765,Assessment of stress markers in restrained individuals following physical stress with and without sham CED activation.,"INTRODUCTION


Law enforcement and pre-hospital care personnel often confront individuals who must be physically restrained. Many are under the influence of illicit substances, and law enforcement officers may need to use a controlled electrical device (CED) to gain control of the individual and they are often placed into the prone maximum restraint (PMR) position. These techniques have previously been evaluated for their physiologic effects. The purpose of this study was to investigate the psychological effects of anticipating and experiencing a sham CED activation in healthy human subjects who were exercised and restrained compared with no sham activation by assessing the differences in a panel of several known biomarkers of stress.
METHODS


We performed a randomized, crossover controlled human subject trial to study the stress associated with exercise, physical exhaustion, and restraint with and without an added psychological stress simulating the field use of a CED. Twenty five total subjects; each subject performed two different trials each consisting of a brief period of intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress. Blood samples were collected for analysis pre and post exercise, as well as 10 min after completion of the exercise. A panel of hormones and stress markers were measured.
RESULTS


We found no significant differences in any of the stress biomarkers measured between the two study groups. A trend towards higher levels of copeptin was measured in the sham CED activation arm.
CONCLUSION


During a brief period of intense exercise followed by the psychological stress of anticipated CED application, there did not appear to be statistically significant changes in the stress panel of biomarkers measured, only a trend towards significance for higher copeptin levels in the patients exposed to the psychological stress.",2020,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"['healthy human subjects', 'Twenty five total subjects']",['intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress'],"['stress biomarkers', 'levels of copeptin']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",25.0,0.0515782,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sloane', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA. Electronic address: csloane@ucsd.edu.'}, {'ForeName': 'Deborah C', 'Initials': 'DC', 'LastName': 'Mash', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Chan', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Kolkhorst', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University San Diego, CA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Neuman', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Castillo', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lasoff', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Wardi', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA; Division of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}]",Journal of forensic and legal medicine,['10.1016/j.jflm.2020.101982']
2346,32658797,Addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia improves analgesic efficacy after tonsillectomy and adenoidectomy: A randomized controlled trial.,"OBJECTIVES


The aim of this study was to determine whether the addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia was more effective than ropivacaine alone in attenuating pain after tonsillectomy and adenoidectomy.
METHODS


This was a double-blind randomized clinical trial. One hundred and twenty children scheduled for tonsillectomy and adenoidectomy using a combination of general anaesthesia and local infiltration anaesthesia were randomized into the dexmedetomidine plus ropivacaine group (DR) and ropivacaine group (R). The children were locally infiltrated with 1 μg kg -1  dexmedetomidine and 0.25% ropivacaine in the DR group or 0.25% ropivacaine alone in the R group. In both groups, local infiltration anaesthesia was performed using 5 ml of solution. The pain scores were recorded at the 1st, 4th, 8th, 12th, 16th, 20th, and 24th hours after surgery using the Face Legs Activity Cry Consolability (FLACC) scale. When the pain score exceeded 4, paracetamol syrup (15 mg kg -1 ) was administered as a rescue analgesic. Time to the first administration of analgesic was recorded.
RESULTS


8th, 16th, 20th, and 24th hours after surgery, the children in the DR group had lower pain scores than those in the R group (P<0.05). The time to the first administration of analgesic was significantly longer in the DR group (mean: 10.4 h, range: 9.4-11.4 h) than in the R group (mean: 8.1 h, range: 7.3-8.8 h) (P < 0.001).
CONCLUSION


The addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia effectively improved the efficacy of analgesia and extended the duration of analgesia after tonsillectomy and adenoidectomy.",2020,The addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia effectively improved the efficacy of analgesia and extended the duration of analgesia after tonsillectomy and adenoidectomy.,['One hundred and twenty children scheduled for tonsillectomy and adenoidectomy using a combination of general anaesthesia and local infiltration anaesthesia'],"['dexmedetomidine plus ropivacaine', 'tonsillectomy and adenoidectomy', 'ropivacaine', 'paracetamol syrup', 'dexmedetomidine']","['pain scores', 'Face Legs Activity Cry Consolability (FLACC) scale', 'efficacy of analgesia and extended the duration of analgesia', 'time to the first administration of analgesic', 'analgesic efficacy', 'pain', 'pain score', 'lower pain scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",120.0,0.171204,The addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia effectively improved the efficacy of analgesia and extended the duration of analgesia after tonsillectomy and adenoidectomy.,"[{'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China.""}, {'ForeName': 'Zanqing', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China.""}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China.""}, {'ForeName': 'Buhuai', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China. Electronic address: dongbuhai@sina.com.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110168']
2347,32658817,Effects of family-focused therapy on suicidal ideation and behavior in youth at high risk for bipolar disorder.,"BACKGROUND


Youth who are at clinical and familial risk for bipolar disorder (BD) often have significant suicidal ideation (SI). In a randomized trial, we examined whether family-focused therapy (FFT) is associated with reductions in SI and suicidal behaviors in high-risk youth.
METHODS


Participants (ages 9-17 years) met diagnostic criteria for unspecified BD or major depressive disorder with active mood symptoms and had at least one relative with BD type I or II. Participants were randomly allocated to 12 sessions in 4 months of FFT or 6 sessions in 4 months of psychoeducation (enhanced care, EC), with pharmacotherapy as needed. Clinician- and child-rated assessments of mood, suicidal thoughts and behaviors, and family conflict were obtained at baseline and 4-6 month intervals over 1-4 years.
RESULTS


Participants (N=127; mean 13.2±2.6 yrs., 82 female) were followed over an average of 105.9±64.0 weeks. Youth with high baseline levels of SI who received FFT had lower levels of (and fewer weeks with) SI at follow-up compared to youth with high baseline SI who received EC. Participants in FFT had longer intervals without suicidal behaviors than participants in EC. Youths' ratings of family conflict significantly mediated the effects of treatment on SI at follow-up.
LIMITATIONS


Family conflict was based on questionnaires rather than observer ratings of family interactions.
CONCLUSIONS


Family psychoeducation with skill training can be an effective deterrent to suicidal thoughts and behaviors in youth at high risk for BD. Reducing parent/offspring conflict should be a central objective of psychosocial interventions for high-risk youth with SI.",2020,"Youths' ratings of family conflict significantly mediated the effects of treatment on SI at follow-up.
","['Youth who are at clinical and familial risk for bipolar disorder (BD', 'youth at high risk for bipolar disorder', 'Participants (N=127; mean 13.2±2.6 yrs., 82 female', 'high-risk youth with SI', 'Participants (ages 9-17 years) met diagnostic criteria for unspecified BD or major depressive disorder with active mood symptoms and had at least one relative with BD type I or II', 'Youth with high baseline levels of SI who received']","['FFT or 6 sessions in 4 months of psychoeducation (enhanced care, EC', 'family-focused therapy', 'FFT', 'skill training', 'family-focused therapy (FFT']","['longer intervals without suicidal behaviors', 'SI and suicidal behaviors', 'mood, suicidal thoughts and behaviors, and family conflict', 'suicidal ideation and behavior']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}]",127.0,0.111281,"Youths' ratings of family conflict significantly mediated the effects of treatment on SI at follow-up.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Los Angeles (UCLA) School of Medicine, University of California, 760 Westwood Plaza Rm A8-256, Los Angeles, 90024-1759 CA, USA. Electronic address: dmiklowitz@mednet.ucla.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Merranko', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Los Angeles (UCLA) School of Medicine, University of California, 760 Westwood Plaza Rm A8-256, Los Angeles, 90024-1759 CA, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Los Angeles (UCLA) School of Medicine, University of California, 760 Westwood Plaza Rm A8-256, Los Angeles, 90024-1759 CA, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.015']
2348,32658822,Improvements in irritability with sertraline versus placebo: Findings from the EMBARC study.,"BACKGROUND


This report seeks to evaluate improvements in symptoms of irritability with sertraline (a selective serotonin reuptake inhibitor antidepressant) versus placebo.
METHODS


Participants of Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study who were randomized to 8 weeks of treatment with either sertraline or placebo and completed 5-item irritability domain of Concise Associated Symptom Tracking scale (CAST-IRR) at baseline were included (n = 292). Repeated measures mixed model analysis with CAST-IRR as the outcome variable and treatment arm-by-time interaction as the independent variable of interest evaluated whether changes in irritability with treatment differed between sertraline and placebo arms. A separate analysis controlled for levels of overall depression severity (17-item Hamilton Depression Rating Scale). Covariates included age, sex, race, ethnicity, and site.
RESULTS


There was a significant treatment arm-by-time interaction (F = 6.96, df = 6, 1418, p <0.0001) suggesting that changes in irritability with sertraline differed from placebo. The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56). After controlling for levels of overall depression severity at each visit, reduction in irritability with time continued to be significant with sertraline but not with placebo.
LIMITATIONS


Secondary analysis, limited generalizability, lack of non-serotonergic antidepressants.
DISCUSSION


There is greater improvement in irritability with sertraline than with placebo. Improvement in irritability with sertraline was independent of its effects on overall depression severity. CLINICALTRIALS.
GOV IDENTIFIER


NCT01407094.",2020,The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56).,['Participants of Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study who'],"['sertraline or placebo', 'sertraline', 'placebo']","['5-item irritability domain of Concise Associated Symptom Tracking scale (CAST-IRR', 'reduction in irritability', 'overall depression severity', 'irritability', 'overall depression severity (17-item Hamilton Depression Rating Scale']","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",,0.370511,The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56).,"[{'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin Fatt', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States. Electronic address: madhukar.trivedi@utsouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.021']
2349,32659116,Substitution of parts of aerobic training by resistance training lowers fasting hyperglycemia in individuals with metabolic syndrome.,"We sought to determine the effects of substituting parts of aerobic training (AT) by resistance training (RT) on metabolic syndrome (MetS) factors. MetS patients (56±7 years old; BMI 33±5 kg·m-2 and 3.9±0.8 MetS factors) were randomized to undergo one of the following isocaloric, 16-week long exercise programs: i) cycling 4 bouts of 4-min at 90% of HRmax followed by 3 sets of 12 repetitions of 3 lower limb free-weight exercises (HIIT+RT group; n=33), ii) cycling 5 bouts of 4-min at 90% of HRmax (HIIT+HIIT group; n=33) or iii) no exercise control group (CONT group; n=21). We measured the evolution of all five MetS components (Z-score), cardiorespiratory fitness (VO2max), leg strength and power (leg press 1RM and countermovement jump (CMJ)), fasting blood glucose (FG), insulin (FI) and insulin resistance (HOMA2). Both training groups improved VO2max similarly (170±310 and 190±210 mLO2·min-1; P<0.001) and Z-score (-0.12±0.29 and -0.12±0.31 for HIIT+RT and HIIT+HIIT, respectively; P<0.02). However, only HIIT+RT improved CMJ (P=0.002) and leg press 1RM above the HIIT+HIIT group (21% vs 6%; P<0.001). Furthermore, FG only decreased in the HIIT+RT group (5%; P=0.026, time x group). Our findings suggest that substitution of part of HIIT by leg RT, improves glucose control in MetS individuals. Bullets Points: •Most studies addressing the efficacy of endurance vs resistance training are not matched by energy expenditure. •We found that substituting 20% of aerobic training with resistance training reduces hyperglycemia in MetS individuals. •Thus, training recommendations to regain glycemic control in MetS individuals should include resistance training.",2020,"However, only HIIT+RT improved CMJ (P=0.002) and leg press 1RM above the HIIT+HIIT group (21% vs 6%; P<0.001).","['MetS patients (56±7 years old; BMI 33±5 kg·m-2 and 3.9±0.8 MetS factors', 'individuals with metabolic syndrome']","['isocaloric, 16-week long exercise programs: i) cycling 4 bouts of 4-min at 90% of HRmax followed by 3 sets of 12 repetitions of 3 lower limb free-weight exercises (HIIT+RT group; n=33), ii) cycling 5 bouts of 4-min at 90% of HRmax (HIIT+HIIT group; n=33) or iii) no exercise control group (CONT', 'aerobic training with resistance training', 'aerobic training by resistance training', 'endurance vs resistance training', 'substituting parts of aerobic training (AT) by resistance training (RT']","['HIIT+RT improved CMJ', 'leg press 1RM', 'metabolic syndrome (MetS) factors', 'glucose control', 'evolution of all five MetS components (Z-score), cardiorespiratory fitness (VO2max), leg strength and power (leg press 1RM and countermovement jump (CMJ)), fasting blood glucose (FG), insulin (FI) and insulin resistance (HOMA2', 'VO2max', 'hyperglycemia', 'Z-score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",,0.0148733,"However, only HIIT+RT improved CMJ (P=0.002) and leg press 1RM above the HIIT+HIIT group (21% vs 6%; P<0.001).","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'University of Castilla - La Mancha, Exercise Physiology Laboratory, Toledo, Spain ; alfonso.moreno@uclm.es.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'University of Castilla - La Mancha, Exercise Physiology Laboratory , Avda Carlos III s/n , 45071 , Toledo, Spain , 45002 ; JuanFernando.Ortega@uclm.es.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Universidad de Castilla La Mancha, Exercise Physiology Lab, Toledo, Spain ; felix.morales@uclm.es.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Universidad de Castilla La Mancha, Exercise Physiology Lab, Toledo, Spain ; miguel.ramirez@uclm.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'University of Castilla - La Mancha, Exercise Physiology Laboratory, Toledo, Spain ; laura.alvarez@uclm.es.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Universidad de Castilla La Mancha , Dept. of Sports Sciences , Avda. Carlos III, s/n , Toledo, Spain , 45071 ; Ricardo.Mora@uclm.es.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0281']
2350,32659136,Effect of Tranexamic Acid on Wound Complications and Blood Loss in Total Ankle Arthroplasty.,"BACKGROUND


Tranexamic acid (TXA) is a medication that has been shown to decrease blood loss and risk of blood transfusion in total knee and total hip arthroplasty. The purpose of this study was to evaluate the use of TXA in patients undergoing total ankle arthroplasty (TAA). We hypothesized there would be less blood loss and wound complications in patients receiving TXA.
METHODS


A retrospective review of 2 patient cohorts operated on by 2 surgeons was performed from 2010 to 2018. We compared a group of TAA patients that did not receive TXA vs a subsequent group that received TXA. Patients received 1g intravenous TXA before the tourniquet was inflated followed by another 1 g after release of the tourniquet. Intraoperative blood loss was recorded and preoperative hemoglobin and hematocrit levels were compared to postoperative levels. Intraoperative and postoperative complications were compared between the 2 groups. A total of 119 patients were included in the study, of whom 55 received TXA. No significant difference existed between the 2 groups in gender, age, body mass index, or Charlson comorbidity index.
RESULTS


There was no difference in estimated blood loss, postoperative hemoglobin/hematocrit values or preoperative to postoperative change in hemoglobin/hematocrit values. Additionally, there was no difference in wound complications or overall complication rate between the groups.
CONCLUSION


TXA has been shown to be effective in total knee and total hip arthroplasty in decreasing blood loss and transfusion risk. We did not find it to be effective in reducing intraoperative blood loss, perioperative blood loss, or wound complications in TAA.
LEVEL OF EVIDENCE


Level III, comparative study.",2020,"We did not find it to be effective in reducing intraoperative blood loss, perioperative blood loss, or wound complications in TAA.
","['A total of 119 patients were included in the study, of whom 55 received', 'Total Ankle Arthroplasty', 'patients undergoing total ankle arthroplasty (TAA', 'total knee and total hip arthroplasty', 'patients receiving TXA', '2 patient cohorts operated on by 2 surgeons was performed from 2010 to 2018']","['Tranexamic Acid', 'Tranexamic acid (TXA', 'TXA', 'intravenous TXA']","['Intraoperative and postoperative complications', 'Wound Complications and Blood Loss', 'wound complications or overall complication rate', 'preoperative hemoglobin and hematocrit levels', 'blood loss and wound complications', 'Intraoperative blood loss', 'estimated blood loss, postoperative hemoglobin/hematocrit values or preoperative to postoperative change in hemoglobin/hematocrit values', 'intraoperative blood loss, perioperative blood loss, or wound complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0188664', 'cui_str': 'Prosthetic total arthroplasty of ankle'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",119.0,0.0722524,"We did not find it to be effective in reducing intraoperative blood loss, perioperative blood loss, or wound complications in TAA.
","[{'ForeName': 'R Garrett', 'Initials': 'RG', 'LastName': 'Steinmetz', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luick', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tkach', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Falcon', 'Affiliation': 'Department of Orthopedic Surgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stoner', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hollabaugh', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Ringus', 'Affiliation': 'Orthopaedic and Sports Medicine Center of Norman, Norman, OK, USA.'}, {'ForeName': 'Amgad M', 'Initials': 'AM', 'LastName': 'Haleem', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}]",Foot & ankle international,['10.1177/1071100720934889']
2351,32659162,Compression stocking prevents increased venous retrograde flow time in the lower limbs of pregnant women.,"OBJECTIVES


To analyze the effect of graduated compression stockings on the venous reflux in the lower limbs of pregnant women.
METHOD


A controlled randomized clinical trial was performed with sixty women: intervention group (n = 30), who used compression stockings, and control group (n = 30). Using duplex-ultrasound, the reflux time and peak reflux velocity in the great saphenous vein and small saphenous vein were analyzed.
RESULTS


Great saphenous vein reflux times in the intervention group were 0.13 s at the beginning (initial) and 0.04 s at the end of pregnancy (final) in the right leg and 0.02 s and 0.34 s (p < 0.0001) in the control group. No patient in the intervention group experienced pathological reflux at the end of the pregnancy. There was a significant difference in the reflux time measured from both the great saphenous vein and small saphenous vein and peak reflux velocity between the groups.
CONCLUSION


Compression stockings prevent increased venous reflux in lower limbs of pregnant women.",2020,"There was a significant difference in the reflux time measured from both the great saphenous vein and small saphenous vein and peak reflux velocity between the groups.
","['sixty women', 'pregnant women']","['graduated compression stockings', 'Compression stocking', 'Compression stockings', 'intervention group (n\u2009=\u200930), who used compression stockings']","['venous reflux', 'venous retrograde flow time', 'great saphenous vein and small saphenous vein and peak reflux velocity', 'pathological reflux', 'Great saphenous vein reflux times', 'reflux time and peak reflux velocity', 'reflux time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0226827', 'cui_str': 'Structure of small saphenous vein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",60.0,0.0497986,"There was a significant difference in the reflux time measured from both the great saphenous vein and small saphenous vein and peak reflux velocity between the groups.
","[{'ForeName': 'Orlando Adas Saliba', 'Initials': 'OAS', 'LastName': 'Junior', 'Affiliation': 'Department of Surgery and Orthopedic Surgery, São Paulo State University (UNESP), Medical School, Botucatu, Brazil.'}, {'ForeName': 'Hamilton Almeida', 'Initials': 'HA', 'LastName': 'Rollo', 'Affiliation': 'Department of Surgery and Orthopedic Surgery, São Paulo State University (UNESP), Medical School, Botucatu, Brazil.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Saliba', 'Affiliation': 'School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Marcone Lima', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Department of Surgery and Orthopedic Surgery, São Paulo State University (UNESP), Medical School, Botucatu, Brazil.'}]",Phlebology,['10.1177/0268355520939371']
2352,32659247,Children overcoming picky eating (COPE) - A cluster randomised controlled trial.,"OBJECTIVES


Food neophobia limits dietary variety in children and adults. Interventions to alleviate the impact of neophobia on children's dietary variety have had varying success. The potential effectiveness of mindfulness, a process of bringing awareness to the present moment, has received little attention. This trial aimed to explore the effectiveness of two mindfulness exercises on novel food acceptance for children.
METHODS


A cluster-randomised controlled trial with three trial arms compared the impact of two mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task on anticipated liking and intake of a novel fruit. Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention. Children self-reported mindfulness, food neophobia and anxiety at baseline and follow-up.
RESULTS


Two mixed-effects models showed that, controlling for school effects and covariates (including mindfulness, food neophobia and anxiety), children in the mindful raisin-eating arm reported greater anticipated liking of a novel fruit and children in both mindfulness arms consumed greater amounts of a novel fruit than children in the control arm. Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
CONCLUSIONS


The results provide promising evidence for the potential effectiveness of mindfulness interventions in encouraging children to try new foods. The mechanisms underlying effectiveness remain unclear and further research, exploring long-term effects and the possibility to generalise these findings to other food groups such as vegetables, is needed.",2020,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","['children and adults', 'Children overcoming picky eating (COPE) ', 'Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention', 'children']","['mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task', 'mindfulness exercises']","['school effects and covariates (including mindfulness, food neophobia and anxiety', 'mindfulness, food neophobia and anxiety', 'Children self-reported mindfulness, food neophobia and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",71.0,0.0797824,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","[{'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': 'Birmingham and Solihull Mental Health NHS Foundation Trust, UK. Electronic address: carmelbennett@nhs.net.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'School of Psychology, University of Birmingham, UK; Birmingham and Solihull Mental Health NHS Foundation Trust, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, University of Birmingham, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Blissett', 'Affiliation': 'Department of Psychology, School of Life and Health Sciences, Aston University, UK.'}]",Appetite,['10.1016/j.appet.2020.104791']
2353,32659482,Transcranial Random Noise Stimulation is More Effective than Transcranial Direct Current Stimulation for Enhancing Working Memory in Healthy Individuals: Behavioural and Electrophysiological Evidence.,"BACKGROUND


Transcranial direct current stimulation (tDCS) has been shown to improve working memory (WM) performance in healthy individuals, however effects tend to be modest and variable. Transcranial random noise stimulation (tRNS) can be delivered with a direct-current offset (DC-offset) to induce equal or even greater effects on cortical excitability than tDCS. To-date, no research has directly compared the effects of these techniques on WM performance or underlying neurophysiological activity.
OBJECTIVE


To compare the effects of anodal tDCS, tRNS + DC-offset, or sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) on WM performance and task-related EEG oscillatory activity in healthy adults.
METHODS


Using a between-subjects design, 49 participants were allocated to receive either anodal tDCS (N = 16), high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC. Changes in WM performance were assessed using the Sternberg WM task completed before and 5- and 25-minutes post-stimulation. Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity was analysed from EEG recorded during WM encoding and maintenance.
RESULTS


tRNS induced more pronounced and consistent enhancements in WM accuracy when compared to both tDCS and sham stimulation. Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
CONCLUSIONS


These findings demonstrate the potential of tRNS + DC-offset to modulate cognitive and electrophysiological measures of WM and raise the possibility that tRNS + DC-offset may be more effective and reliable than tDCS for enhancing WM performance in healthy individuals.",2020,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","['49 participants', 'healthy individuals', 'healthy adults', 'Healthy Individuals']","['Transcranial direct current stimulation (tDCS', 'high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC', 'anodal tDCS', 'tDCS', 'Transcranial random noise stimulation (tRNS', 'Transcranial Direct Current Stimulation', 'Transcranial Random Noise Stimulation', 'anodal tDCS, tRNS + DC-offset, or sham stimulation']","['WM performance and task-related EEG oscillatory activity', 'Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity', 'Changes in WM performance', 'working memory (WM) performance', 'WM accuracy', 'theta ERS and diminished gamma ERD', 'WM performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",49.0,0.0357647,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","[{'ForeName': 'O W', 'Initials': 'OW', 'LastName': 'Murphy', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Central Clinical School, The Alfred and Monash University, Melbourne, Australia; Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, Victoria, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, Victoria, Australia. Electronic address: oscar.murphy@monash.edu.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, Victoria, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, Victoria, Australia. Electronic address: kate.hoy@monash.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; School of Psychology and Public Health, La Trobe University, Bundoora, Victoria, Australia. Electronic address: d.wong@latrobe.edu.au.'}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Bailey', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, Victoria, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, Victoria, Australia. Electronic address: neil.bailey@monash.edu.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, Victoria, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, Victoria, Australia. Electronic address: paul.fitzgerald@monash.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Segrave', 'Affiliation': 'Brain and Mental Health Research Hub, School of Psychological Sciences and Monash Biomedical Imaging, Monash Institute of Cognitive and Clinical Neuroscience, Monash University, Clayton, Australia. Electronic address: rebecca.segrave@monash.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.07.001']
2354,32659483,Non-Invasive Vagal Nerve Stimulation Decreases Brain Activity During Trauma Scripts.,"BACKGROUND


Traumatic stress can have lasting effects on neurobiology and result in psychiatric conditions such as posttraumatic stress disorder (PTSD). We hypothesize that non-invasive cervical vagal nerve stimulation (nVNS) may alleviate trauma symptoms by reducing stress sympathetic reactivity. This study examined how nVNS alters neural responses to personalized traumatic scripts.
METHODS


Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study. In three sequential time blocks, personalized traumatic scripts were presented to participants immediately followed by either sham stimulation (n = 8; 0-14 V, 0.2 Hz, pulse width = 5s) or active nVNS (n = 11; 0-30 V, 25 Hz, pulse width = 40 ms). Brain activity during traumatic scripts was assessed using High Resolution Positron Emission Tomography (HR-PET) with radiolabeled water to measure brain blood flow.
RESULTS


Traumatic scripts resulted in significant activations within the bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen. Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate. During the first exposure to the trauma scripts, greater activations were found in the motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations were more predominant with later script presentations for those subjects receiving sham stimulation.
CONCLUSION


nVNS decreases neural reactivity to an emotional stressor in limbic and other brain areas involved in stress, with changes over repeated exposures suggesting a shift from scene appraisal to cognitively processing the emotional event.",2020,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.",['Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study'],"['invasive cervical vagal nerve stimulation (nVNS', 'active nVNS', 'nVNS']","['bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen', 'motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations', 'Greater activation', 'Brain activity']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",19.0,0.0708328,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA. Electronic address: mattwittbrodt@emory.edu.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Minxuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA; Atlanta VA Medical Center, Decatur, GA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Pearce', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Zuhayr S', 'Initials': 'ZS', 'LastName': 'Alam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Rapaport', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Murrah', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Ammer A', 'Initials': 'AA', 'LastName': 'Haffer', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Shallenberger', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA; Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA; Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA; Department of Radiology, Emory University School of Medicine, Atlanta, GA; Atlanta VA Medical Center, Decatur, GA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.002']
2355,32659637,Cost and cost-effectiveness of three strategies for implementing motivational interviewing for substance misuse on medical inpatient units.,"BACKGROUND


This study conducted cost and cost-effectiveness analyses of three strategies for implementing motivational interviewing for substance misuse on general medical inpatient units: workshop, apprenticeship, and consult.
METHODS


The economic analyses were conducted prospectively alongside a type 3 hybrid effectiveness-implementation randomized trial comprising 38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts. The trial took place in a university affiliated teaching hospital in New Haven, CT, USA. After completing a 1-day workshop on motivational interviewing, providers were randomized to conditions. The primary outcome measure was the number of study-eligible patients who received a motivational interview. The economic analyses included the costs of both start-up and on-going activities in each condition. Incremental cost-effectiveness ratios were used to determine cost effectiveness. Results are presented from the healthcare provider (i.e., hospital) perspective in 2018 US dollars.
RESULTS


The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively. Workshop and apprenticeship were extended dominated by the combination of consult and doing nothing. Doing nothing is cost effective when the willingness-to-pay for an additional patient receiving a motivational interview is less than $185.65, and consult is cost-effective when the willingness-to-pay for an additional patient receiving a motivational interview is greater than $185.65.
CONCLUSIONS


Given that typical reimbursements for brief intervention services for substance misuse are $35-$65, none of the three implementation strategies is likely to be economically viable from the healthcare provider perspective.",2020,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","['substance misuse on medical inpatient units', '38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts', 'university affiliated teaching hospital in New Haven, CT, USA']",['implementing motivational interviewing'],"['Cost and cost-effectiveness', 'Incremental cost-effectiveness ratios', 'total cost per patient receiving a motivational interview']","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",38.0,0.0294972,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'The University of Texas at Austin, Lyndon B. Johnson School of Public Affairs, Sid Richardson Hall, Unit 3, Austin, TX, 78712, USA. Electronic address: tolmstead@austin.utexas.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; Yale School of Medicine, Department of Obstetrics, Gynecology & Reproductive Sciences, 333 Cedar Street, New Haven, CT, 06510, USA; Yale School of Epidemiology and Public Health Division of Chronic Disease, 60 College Street, New Haven, CT, 06520, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; VA Connecticut Healthcare System, Psychology Service, 950 Campbell Avenue (116B), West Haven, CT, 06516, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108156']
2356,32651585,Music Therapy to Regulate Arousal and Attention in Patients With Substance Use Disorder and Posttraumatic Stress Disorder: A Feasibility Study.,"Patients diagnosed with both substance use disorder (SUD) and posttraumatic stress disorder (PTSD) often experience hypervigilance, increased fear, and difficulties regulating emotions. This dual diagnosis increases treatment complexity. Recently, a short-term music therapy intervention for arousal and attention regulation (the SMAART intervention) was designed based on neurobiological findings. Twelve patients with SUD and PTSD (50% females) in outpatient treatment participated in six weekly one-hour sessions of the SMAART intervention. Six patients completed the study. PTSD symptom severity was evaluated with the Posttraumatic Stress Disorder Symptom Scale Interview for DSM-5 (PSSI-5) pre- and post-intervention, and sustained attention was evaluated with the Bourdon-Wiersma (BW) test. A significant difference in measurements for the PSSI-5 overall symptom severity was found pre- and post-intervention. Furthermore, participants showed significant improvement on subscales of hyperarousal, mood and cognition, and attention. The BW test completion time decreased significantly. Two participants dropped out before the end of the intervention due to craving. Concerning future research, it is recommended to define the role of the music more explicitly and to change the design to a randomized controlled trial. A risk for future larger studies is a high dropout rate (50%). Several limitations of the study are discussed.",2020,A significant difference in measurements for the PSSI-5 overall symptom severity was found pre- and post-intervention.,"['Six patients completed the study', 'Posttraumatic Stress Disorder', 'Patients', 'Patients diagnosed with both substance use disorder (SUD) and posttraumatic stress disorder (PTSD', 'Twelve patients with SUD and PTSD (50% females']",['Music Therapy'],"['PTSD symptom severity', 'BW test completion time', 'subscales of hyperarousal, mood and cognition, and attention', 'PSSI-5 overall symptom severity', 'Posttraumatic Stress Disorder Symptom Scale Interview for DSM-5']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",12.0,0.0188963,A significant difference in measurements for the PSSI-5 overall symptom severity was found pre- and post-intervention.,"[{'ForeName': 'Laurien', 'Initials': 'L', 'LastName': 'Hakvoort', 'Affiliation': 'ArtEZ University of the Artsm, Enschede, The Netherlands.'}, {'ForeName': 'Sirik', 'Initials': 'S', 'LastName': 'de Jong', 'Affiliation': 'ArtEZ University of the Artsm, Enschede, The Netherlands.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'van de Ree', 'Affiliation': 'ArtEZ University of the Artsm, Enschede, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kok', 'Affiliation': 'Tactus, Addiction Care Twente, Enschede, The Netherlands.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Macfarlane', 'Affiliation': 'Penitentiary Psychiatric Center Institution Vught & Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Haan', 'Affiliation': 'Tactus, Addiction Care Twente, Enschede, The Netherlands.'}]",Journal of music therapy,['10.1093/jmt/thaa007']
2357,32651772,Effect of high-intensity statin preloading on TIMI flow in patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.,"BACKGROUND


Acute ST-elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. Primary percutaneous coronary intervention (PCI) has improved the outcomes from STEMI and improved myocardial perfusion. However, there is still room for medical therapy to help perfuse the myocardium. The aim of this study was to assess the impact of high-intensity statins used prior to primary PCI in patients presenting with acute STEMI on myocardial perfusion. The study included 170 patients who presented with acute STEMI to Ain Shams University Hospitals and underwent primary percutaneous coronary intervention (PCI). They were divided into two groups where the first group received high-intensity statins (80 mg of atorvastatin or 20 mg of rosuvastatin) besides guideline-recommended therapy before primary PCI and the second group served as a control group and received guideline-recommended therapy, and high-intensity statins were given as usual after going back to the coronary care unit after primary PCI. Post-interventional thrombolysis in myocardial infarction (TIMI) flow grade and myocardial blush grade (MBG) were recorded, and ST-segment resolution was measured.
RESULTS


The LAD was the culprit vessel for the majority of patients in both groups. In the control group, there were 4 patients with TIMI I flow and MBG I, 13 with TIMI II flow and MBG II, and 68 with TIMI III flow and MBG III. Meanwhile, in the cases group, there was 1 patient with TIMI I flow and MBG I, 3 with TIMI II flow and MBG II, and 81 with TIMI III flow and MBG III. This difference was statistically significant with a P value of 0.010. There were 34 patients in the cases group who showed complete ST-segment resolution (40%) vs. 19 patients (22.4%) in the control group which was statistically significant with a P value of 0.013. In addition, ejection fraction had values of mean ± SD of 45.91 ± 5.49 in the cases group vs. 43.01 ± 8.80 in the control group which was statistically significant with a P value of 0.011.
CONCLUSION


High-intensity statin loading before primary PCI resulted in improved post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction.",2020,"High-intensity statin loading before primary PCI resulted in improved post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction.","['patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention', '170 patients who presented with acute STEMI to Ain Shams University Hospitals and underwent primary percutaneous coronary intervention (PCI', 'patients presenting with acute STEMI on myocardial perfusion', '4 patients with TIMI']","['high-intensity statin preloading', 'TIMI', 'Primary percutaneous coronary intervention (PCI', 'high-intensity statins (80\u2009mg of atorvastatin or 20\u2009mg of rosuvastatin) besides guideline-recommended therapy before primary PCI and the second group served as a control group and received guideline-recommended therapy, and high-intensity statins']","['complete ST-segment resolution', 'myocardial infarction (TIMI) flow grade and myocardial blush grade (MBG', 'TIMI flow', 'post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction', 'myocardial perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}]",170.0,0.0172981,"High-intensity statin loading before primary PCI resulted in improved post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction.","[{'ForeName': 'Ahmed Shawky', 'Initials': 'AS', 'LastName': 'Elserafy', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt. ahmedshawkyelserafy@gmail.com.'}, {'ForeName': 'Nabil Mahmoud', 'Initials': 'NM', 'LastName': 'Farag', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Ahmed Ibrahim', 'Initials': 'AI', 'LastName': 'El Desoky', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Khaled Adel', 'Initials': 'KA', 'LastName': 'Eletriby', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00074-0']
2358,32649808,In vivo evaluation of the impact of various border molding materials and techniques on the retention of complete maxillary dentures.,"BACKGROUND


Different techniques and impression materials are employed in the process of fabricating complete denture (CD) bases.
OBJECTIVES


The aim of this study was to determine differences in the denture base retention for acrylic maxillary CDs when using 2 different techniques and impression materials. Specifically, the green stick compound impression material was used for the sectional border molding technique and this was compared to using the addition vinyl silicone impression material with the single-step technique.
MATERIAL AND METHODS


A crossover study was conducted on 10 participants who were completely edentulous in the upper arch (6 men and 4 women), aged 43-70 years. The participants' trays were split into 2 treatment groups: the P-group; and the Z-group. Addition vinyl silicone was used for single-step border molding in the P-group, followed by light-body final-wash impression. For the Z-group, the green stick compound was used for sectional border molding, followed by a final wash using a zinc oxideeugenol material.To quantify the retention force of the denture base in kilograms-force, a digital force gauge was used.
RESULTS


The measurements indicated significantly higher mean retention values (p = 0.000) in the P‑group (4.02 ±1.66 kgf) as compared to the Z‑group (1.48 ±0.90 kgf).
CONCLUSIONS


The results suggest the superiority of using the single-step border molding technique in the upper arch with the addition vinyl silicone material owing to the enhanced base retention of the acrylic denture base.",2020,"The measurements indicated significantly higher mean retention values (p = 0.000) in the P‑group (4.02 ±1.66 kgf) as compared to the Z‑group (1.48 ±0.90 kgf).
","['10 participants who were completely edentulous in the upper arch (6 men and 4 women), aged 43-70 years']",['Addition vinyl silicone'],"['retention of complete maxillary dentures', 'mean retention values']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011458', 'cui_str': 'Complete upper denture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",10.0,0.0362127,"The measurements indicated significantly higher mean retention values (p = 0.000) in the P‑group (4.02 ±1.66 kgf) as compared to the Z‑group (1.48 ±0.90 kgf).
","[{'ForeName': 'Tameem Khuder', 'Initials': 'TK', 'LastName': 'Jassim', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Mustansiriyah University, Baghdad, Iraq.'}, {'ForeName': 'Ali Ehsan', 'Initials': 'AE', 'LastName': 'Kareem', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Mustansiriyah University, Baghdad, Iraq.'}, {'ForeName': 'Mohamed Adnan', 'Initials': 'MA', 'LastName': 'Alloaibi', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Mustansiriyah University, Baghdad, Iraq.'}]",Dental and medical problems,['10.17219/dmp/115104']
2359,32650155,Comparative effects of water- and land-based combined exercise training in hypertensive older adults.,"OBJECTIVES


A randomized controlled trial was designed to compare water- and land-based combined (aerobic and resistance) exercise training programs on cardiometabolic parameters, functional fitness, and quality-of-life (QoL) in hypertensive older adults.
METHODS


Fifty-three participants were divided into three groups: 1) land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON, n=20). All programs comprised of a 12-week supervised training program (three 1-hr sessions per week), followed by a 12-week self-supervised training program. Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL were assessed before and after each period.
RESULTS


Following the supervised period, systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL significantly improved in both training groups. Only the WET improved LDL-C and lipoprotein combine index. Meanwhile, the 30s chair-stand test and 2-min step test improved only in the LET. Succeeding the self-supervised period, systolic BP and NOx- concentration significantly improved in both training groups. Notwithstanding, the 30s chair-standing and arm curl tests improved only in the LET.
CONCLUSIONS


Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET. Nevertheless, metabolic variables were greater improved in the WET. Additionally, due to greater exercise participation, the WET program may be a useful tool in motivating hypertensive older adults to continuously exercise on their own.",2020,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","['hypertensive older adults', 'motivating hypertensive older adults', 'Fifty-three participants were divided into three groups: 1']","['water- and land-based combined (aerobic and resistance) exercise training programs', 'land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON', 'supervised training program', 'water- and land-based combined exercise training']","['metabolic variables', 'ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL', 'cardiometabolic parameters, functional fitness, and quality-of-life (QoL', 'systolic BP and NOx- concentration', 'Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL', 'LDL-C and lipoprotein combine index', 'systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",53.0,0.0142118,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","[{'ForeName': 'Ratree', 'Initials': 'R', 'LastName': 'Ruangthai', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Jatuporn', 'Initials': 'J', 'LastName': 'Phoemsapthawee', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand. Electronic address: jatuporn.w@ku.th.'}, {'ForeName': 'Niromlee', 'Initials': 'N', 'LastName': 'Makaje', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Phornphon', 'Initials': 'P', 'LastName': 'Phimphaphorn', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104164']
2360,32650347,Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose.,"BACKGROUND


This study evaluated the impact of power setting and proton pump inhibitor (PPI) dose on efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD). METHODS : 71 patients were randomized to APC with power set at 90 W or 60 W followed by 120 mg or 40 mg omeprazole. The primary outcome was the rate of complete (endoscopic and histologic) ablation of BE at 6 weeks. Secondary outcomes included safety and long-term efficacy. RESULTS : Complete ablation rate in the 90 W/120 mg, 90 W/40 mg, and 60 W/120 mg groups was 78 % (18/23; 95 % confidence interval [CI] 61-95), 60 % (15/25; 95 %CI 41-79), 74 % (17/23; 95 %CI 56-92), respectively, at 6 weeks and 70 % (16/23; 95 %CI 51-88), 52 % (13/25; 95 %CI 32-72), and 65 % (15/23; 95 %CI 46-85) at 2 years post-treatment (differences not significant). Additional APC was required in 28 patients (23 residual and 5 recurrent BE). At median follow-up of 108 months, 66/71 patients (93 %; 95 %CI 87-99) maintained complete ablation. No high-grade dysplasia or adenocarcinoma developed. Overall, adverse events (97 % mild) did not differ significantly between groups. Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001). One patient had esophageal perforation and two developed stenosis.
CONCLUSIONS


APC power setting and PPI dose did not impact efficacy and safety of BE ablation. Complete ablation of BE with LGD was durable in > 90 % of patients, without any evidence of neoplasia progression in the long term.",2020,Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001).,"[""Barrett's esophagus with low-grade dysplasia"", ""Barrett's esophagus (BE) with low-grade dysplasia (LGD"", '28 patients (23 residual and 5 recurrent BE', '71 patients']","['omeprazole', 'Argon plasma coagulation', 'power setting and proton pump inhibitor (PPI', 'argon plasma coagulation (APC']","['Overall, adverse events', 'neoplasia progression', 'esophageal perforation', 'Chest pain/discomfort', 'rate of complete (endoscopic and histologic) ablation of BE', 'stenosis', 'Complete ablation rate', 'safety and long-term efficacy']","[{'cui': 'C1334414', 'cui_str': 'Barretts esophagus with low grade dysplasia'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0014860', 'cui_str': 'Perforation of esophagus'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",71.0,0.245348,Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001).,"[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wronska', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Polkowski', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Orlowska', 'Affiliation': 'Department of Gastroenterological Oncology, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mroz', 'Affiliation': 'Department of Pathomorphology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wieszczy', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Regula', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}]",Endoscopy,['10.1055/a-1203-5930']
2361,32650511,"Short-Term Effect of a New Oral Sodium Hyaluronate Formulation on Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.","OBJECTIVE


the aim of this pilot study was to test the short-term effect of oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA ® ) on the symptoms and functionality of knee osteoarthritis (OA).
METHODS


60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA were consecutively enrolled in a randomized, double blind, placebo-controlled, clinical trial. At randomization visit, at day 28 (visit 2), and day 56 (visit 3), the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p) were administered to the enrolled patients. Then, patients were asked how many times they used rescue medications (non-steroidal antinflammatory drugs - NSAIDs and/or anti-pain drugs) during the previous 4 weeks. Finally, the range of knee joint motion (ROM) was also instrumentally measured.
RESULTS


In FS-HA ®  treated subjects, VAS-p, pain and total WOMAC score, LFI and ROM significantly improved compared to the baseline values ( p  < 0.05). At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05). The FS-HA ®  treated subjects significantly reduced the weekly use of NSAIDs and/or antipain drugs when compared to the placebo-treated ones ( p  < 0.05).
CONCLUSION


the oral supplementation with a FS-HA ®  characterized by a large spectrum of molecular weight was associated with a short-term improvement in symptomatology and functionality of osteoarthritis-affected knees, and associated with a reduction in the use of NSAIDS and anti-pain drugs.",2020,"At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05).","['60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA', 'Knee Osteoarthritis']","['oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA ® ', 'New Oral Sodium Hyaluronate Formulation', 'Placebo', 'placebo']","['Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p', 'VAS-p, pain and total WOMAC score, LFI and ROM', 'range of knee joint motion (ROM', 'pain WOMAC score']","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",60.0,0.177501,"At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05).","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Girolimetto', 'Affiliation': 'Department of Rheumatology, Azienda USL-IRCCS di Reggio Emilia, 42121 Reggio Emilia, Italy.'}, {'ForeName': 'Crescenzio', 'Initials': 'C', 'LastName': 'Bentivenga', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Grandi', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fogacci', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}]","Diseases (Basel, Switzerland)",['10.3390/diseases8030026']
2362,32650518,"Trimebutine Maleate Monotherapy for Functional Dyspepsia: A Multicenter, Randomized, Double-Blind Placebo Controlled Prospective Trial.","Background and Objectives:  Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders; it has a great impact on patient quality of life and is difficult to treat satisfactorily. This study evaluates the efficacy and safety of trimebutine maleate (TM) in patients with FD.  Materials and Methods : Α multicenter, randomized, double-blind, placebo controlled, prospective study was conducted, including 211 patients with FD. Participants were randomized to receive TM 300 mg twice per day (BID, 108 patients) or placebo BID (103 patients) for 4 weeks. The Glasgow Dyspepsia Severity Score (GDSS) was used to evaluate the relief of dyspepsia symptoms. Moreover, as a pilot secondary endpoint, a substudy (eight participants on TM and eight on placebo) was conducted in to evaluate gastric emptying (GE), estimated using a 99mTc-Tin Colloid Semi Solid Meal Scintigraphy test.  Results : Of the 211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed. The groups did not differ in their demographic and medical history data. Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02). The 99 mTc-Tin Colloid Semi Solid Meal Scintigraphy testing showed that TM significantly accelerated GE obtained at 50 min (median emptying 75.5% in the TM group vs. 66.6% in the placebo group,  p  = 0.036). Adverse effects of low to moderate severity were reported in 12.3% of the patients on TM.  Conclusion : TM monotherapy appears to be an effective and safe approach to treating FD, although the findings presented here warrant further confirmation.",2020,"Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02).","['211 patients with FD', '211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed', 'Functional Dyspepsia', 'patients with FD']","['Placebo', 'Trimebutine Maleate Monotherapy', 'Functional dyspepsia (FD', 'TM monotherapy', 'TM', 'trimebutine maleate (TM', 'placebo BID', 'placebo']","['relief of dyspepsia symptoms', 'efficacy and safety', 'Glasgow Dyspepsia Severity Score (GDSS', 'GDSS', 'gastric emptying (GE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0877833', 'cui_str': 'Trimebutine maleate'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}]",211.0,0.534728,"Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02).","[{'ForeName': 'Jannis', 'Initials': 'J', 'LastName': 'Kountouras', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gavalas', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Apostolis', 'Initials': 'A', 'LastName': 'Papaefthymiou', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Tsechelidis', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Bor', 'Affiliation': 'Division of Gastroenterology, Ege University School of Medicine, 35330 Izmir, Turkey.'}, {'ForeName': 'Mircea', 'Initials': 'M', 'LastName': 'Diculescu', 'Affiliation': 'Gastroenterology and Hepatology Department, Clinic Fundeni Institute, 4204003 Bucharest, Romania.'}, {'ForeName': 'Κhaled', 'Initials': 'Κ', 'LastName': 'Jadallah', 'Affiliation': 'Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan.'}, {'ForeName': 'Mazurek', 'Initials': 'M', 'LastName': 'Tadeusz', 'Affiliation': 'Medicor Centrum, ul. Jabłoskiego 2/4 35-068 Rzeszów, Poland.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Karakan', 'Affiliation': 'Department of Gastroenterology, Gazi University School of Medicine, 06560 Ankara, Turkey.'}, {'ForeName': 'Αnna', 'Initials': 'Α', 'LastName': 'Bochenek', 'Affiliation': 'Centrum Badawcze Wspolczesnej Terapii, 02679 Warszawa, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Rozciecha', 'Affiliation': 'LexMedica, Rudolfa Weigla 12, Krzyki, 53114 Wrocław, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dabrowski', 'Affiliation': 'Department of Rheumatology of Clinical Hospital 2, University of Rzeszow, Lwowska 60, 35-301 Rzeszow, Poland.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Sparchez', 'Affiliation': 'Third Medical Clinic, University of Medicine and Pharmacy, Croitorilor Street no.19-21, 400162 Cluj-Napoca, Romania.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Sezgin', 'Affiliation': 'Mersin University, Faculty of Medicine, Department of Gastroenterology, 33343 Mersin, Turkey.'}, {'ForeName': 'Macit', 'Initials': 'M', 'LastName': 'Gülten', 'Affiliation': 'Department of Gastroenterology, Uludag University, 16059 Bursa, Turkey.'}, {'ForeName': 'Niazy Abu', 'Initials': 'NA', 'LastName': 'Farsakh', 'Affiliation': 'Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doulberis', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070339']
2363,32650729,Testing the regulatory framework in South Africa - a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis.,"BACKGROUND


Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment.
METHODS


Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7-10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment.
RESULTS


The  South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24-1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product.
CONCLUSION


Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered.
TRIAL REGISTRATION


This trial was registered on 17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ).",2020,"Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules.","['Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs', 'women with bacterial vaginosis', 'vaginal health in South Africa', '17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ', 'BV+ (Nugent 7-10) but STI- women']","['commercial probiotic supplementation', 'metronidazole followed by a commercial oral/vaginal probiotic', 'commercial oral-vaginal-combination probiotic', 'vaginal metronidazole alone']","['BV recurrence, symptoms, vaginal microbiota and genital cytokine changes', 'BV cure', 'Acceptability and adherence', 'acceptability of vaginal application', 'recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations', 'HIV risk and adverse reproductive outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}]","[{'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.359196,"Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules.","[{'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa. anna.happel@uct.ac.za.'}, {'ForeName': 'Ravesh', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Nireshni', 'Initials': 'N', 'LastName': 'Mitchev', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Koleka', 'Initials': 'K', 'LastName': 'Mlisana', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Shaun L', 'Initials': 'SL', 'LastName': 'Barnabas', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Jo-Ann S', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}]",BMC infectious diseases,['10.1186/s12879-020-05210-4']
2364,32650732,Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial.,"BACKGROUND


Older adults (> 65 years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home. Care transitions for this population are often poorly coordinated and fragmented, resulting in increased readmission rates, adverse medical events, decreased patient satisfaction and safety, and increased caregiver burden. There is a dearth of evidence on best practices in the provision of transitional care for older adults with MCC and depressive symptoms transitioning from hospital-to-home. This paper presents a protocol for a two-armed, multi-site pragmatic effectiveness-implementation trial of Community Assets Supporting Transitions (CAST), an evidence-informed nurse-led six-month intervention that supports older adults with MCC and depressive symptoms transitioning from hospital-to-home. The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.
METHODS


Participants will be considered eligible if they are > 65 years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms. A total of 216 eligible and consenting participants will be randomly assigned to the control (usual care) or intervention (CAST) arm. The intervention consists of tailored care delivery comprising in-home visits, telephone follow-up and system navigation support. The primary measure of effectiveness is mental health functioning of the older adult participant. Secondary outcomes include changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months. Caregivers will be assessed for caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs. Descriptive and qualitative data from older adult and caregiver participants, and the nurse interventionists will be used to examine implementation of the intervention, how the intervention is adapted within each study region, and its potential for sustainability and scalability to other jurisdictions.
DISCUSSION


A nurse-led transitional care strategy may provide a feasible and effective means for improving health outcomes and patient/caregiver experience and reduce service use and costs in this vulnerable population.
TRIAL REGISTRATION


# NCT03157999 . Registration Date: April 4, 2017.",2020,"The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.
","['Older adults (> 65\u2009years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home', '216 eligible and consenting participants', 'Participants will be considered eligible if they are >\u200965\u2009years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms', 'older adults with MCC and depressive symptoms transitioning from hospital-to-home', 'older adults with multiple chronic conditions and depressive symptoms', 'older adult and caregiver participants']","['tailored care delivery comprising in-home visits, telephone follow-up and system navigation support', 'Community Assets Supporting Transitions (CAST', 'hospital-to-home transitional care intervention', 'control (usual care) or intervention (CAST']","['caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs', 'changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0011211', 'cui_str': 'Health Care Delivery'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",216.0,0.129255,"The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.
","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada. mreid@mcmaster.ca.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'McAiney', 'Affiliation': 'Murray Alzheimer Research & Education Program (MAREP), School of Public Health and Health Systems, University of Waterloo,University of Waterloo Research Institute for Aging, University of Waterloo, 200 University Avenue West, Waterloo, ON, N2L 3G1, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ganann', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Amiram', 'Initials': 'A', 'LastName': 'Gafni', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact; and Centre for Health Economics and Policy Analysis, McMaster University, 1200 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Alain P', 'Initials': 'AP', 'LastName': 'Gauthier', 'Affiliation': 'School of Human Kinetics, Laurentian University, 935 Ramsey Lake Rd., Sudbury, ON, P3E 2C6, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Heald-Taylor', 'Affiliation': 'Patient Research Partner, Selkirk, ON, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'McElhaney', 'Affiliation': 'Medical Sciences Division, Northern Ontario School of Medicine, Health Sciences North Research Institute, 41 Ramsey Lake Road, Sudbury, ON, P3E 5J1, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Urajnik', 'Affiliation': 'Centre for Rural and Northern Health Research, Laurentian University, 935 Ramsey Lake Rd., Sudbury, ON, P3E 2C6, Canada.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Valaitis', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Whitmore', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}]",BMC geriatrics,['10.1186/s12877-020-01638-0']
2365,32650750,Three-dimensional printing of patient-specific plates for the treatment of acetabular fractures involving quadrilateral plate disruption.,"BACKGROUND


Complicated acetabular fractures comprise the most challenging field for orthopedists. The purpose of this study was to develop three-dimensional printed patient-specific (3DPPS) Ti-6Al-4 V plates to treat complicated acetabular fractures involving quadrilateral plate (QLP) disruption and to evaluate their efficacy.
METHODS


Fifty patients with acetabular fractures involving QLP disruption were selected between January 2016 and June 2017. Patients were divided into a control group (Group A, 35 patients) and an experimental group (Group B, 15 patients), and were treated by the conventional method of shaping reconstruction plates or with 3DPPS Ti-6AL-4 V plates, respectively. The efficacy of Ti-6AL-4 V plates was evaluated by blood loss, operative time, reduction quality, postoperative residual displacement, and complications.
RESULTS


The operative time and blood loss in Group B were reduced compared to Group A, and the difference was statistically significant (P < 0.05). There was no significant difference in reduction quality between the two groups (P > 0.05). Reduction quality in Group B was anatomic in 10 (66.7%), satisfactory in four (26.7%), and poor in one (6.7%). In Group A, they were anatomic in 18 (51.4%), satisfactory in 13 (37.1%), and poor in four (11.4%). Residual displacement in Group B was less than that in Group A, and the difference was statistically significant (P < 0.05). In Group B, one case exhibited loosening of the pubic screw postoperatively. In Group A, there was one case of wound infection, one of deep vein thrombosis (DVT) in the ipsilateral lower limb, one case of traumatic arthritis and two obturator nerve injuries.
CONCLUSIONS


The 3DPPS Ti-6AL-4 V plate is a feasible, accurate and effective implant for acetabular fracture treatment.",2020,"RESULTS


The operative time and blood loss in Group B were reduced compared to Group A, and the difference was statistically significant (P < 0.05).",['Fifty patients with acetabular fractures involving QLP disruption were selected between January 2016 and June 2017'],"['Ti-6AL-4\u2009V plates', 'conventional method of shaping reconstruction plates or with 3DPPS Ti-6AL-4\u2009V plates, respectively']","['operative time and blood loss', 'blood loss, operative time, reduction quality, postoperative residual displacement, and complications', 'reduction quality', 'wound infection, one of deep vein thrombosis (DVT', 'Reduction quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347804', 'cui_str': 'Fracture of acetabulum'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",50.0,0.0148256,"RESULTS


The operative time and blood loss in Group B were reduced compared to Group A, and the difference was statistically significant (P < 0.05).","[{'ForeName': 'Canbin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hand Surgery, and Department of Plastic Reconstructive Surgery, Ningbo No. 6 Hospital, Ningbo, 315040, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'School of Mechanical and Automotive Engineering, South China University of Technology, Guangzhou, 510640, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Fuming', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Lufeng', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Hand Surgery, and Department of Plastic Reconstructive Surgery, Ningbo No. 6 Hospital, Ningbo, 315040, China.'}, {'ForeName': 'Shicai', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China. fanscyi@sohu.com.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China. orthobiomech@163.com.'}, {'ForeName': 'Jianghui', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Hand Surgery, and Department of Plastic Reconstructive Surgery, Ningbo No. 6 Hospital, Ningbo, 315040, China. jianghui.dong@mymail.unisa.edu.au.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03370-7']
2366,32652300,"The impact of adjunctive metformin to progesterone for the treatment of non-atypical endometrial hyperplasia in a randomized fashion, a placebo-controlled, double blind clinical trial.","OBJECTIVE


Endometrial hyperplasia (EH) is a premalignant neoplasm. Most recently, metformin has been suggested as an adjuvant medication for treating of EH with better outcome. Recent evidence has suggested that metformin has anticancer activity by inhibiting cell proliferation and tumor growth. The aim of this study was to evaluate the effect of metformin plus megestrol acetate versus megestrol acetate alone on patient with EH without atypia.
STUDY DESIGN


This double blind placebo-controlled clinical trial was conducted among 60 women with EH without atypia. Participants were allocated to two equal groups. Treatment group (M + M) received 40 mg megestrol acetate for 14 days of one month and 1000 mg metformin daily for three months. In placebo group (M + P) each patient received the same dose of megestrol acetate plus two tablets of placebo. Endometrial biopsy was performed in all patients three weeks after the last day of medication RESULTS: Data were evaluated based on 29 and 27 women in the M + M group and M + P group, respectively. After 3 months of therapy 27 (93.1 %) women in M + M group had not EH and responded to treatment, which was statistically higher than the rate of response (19 women, 70.4 %) in M + P group.
CONCLUSIONS


This study showed that megestrol plus metformin was significantly better than megestrol alone for the treatment of endometrial hyperplasia without atypia.",2020,This study showed that megestrol plus metformin was significantly better than megestrol alone for the treatment of endometrial hyperplasia without atypia.,"['endometrial hyperplasia without atypia in addition to', '60 women with EH without atypia', 'endometrial hyperplasia without atypia', 'patient with EH without atypia']","['megestrol acetate plus two tablets of placebo', '40\u2009mg megestrol acetate', 'progesterone', 'megestrol plus metformin', 'metformin', 'megestrol', 'metformin plus megestrol acetate versus megestrol acetate alone', 'placebo']","['Endometrial biopsy', 'rate of response']","[{'cui': 'C2712711', 'cui_str': 'Benign endometrial hyperplasia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0065879', 'cui_str': 'Megestrol acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0025175', 'cui_str': 'Megestrol'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}]",60.0,0.508186,This study showed that megestrol plus metformin was significantly better than megestrol alone for the treatment of endometrial hyperplasia without atypia.,"[{'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Tehranian', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: afsanehtehranian@yahoo.com.""}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ghahghaei-Nezamabadi', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Arab', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khalagi', 'Affiliation': ""Osteoprosis Research Center Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Research Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Aghajani', 'Affiliation': 'Medical Student, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101863']
2367,32652388,"Buying despite negative consequences: Interaction of craving, implicit cognitive processes, and inhibitory control in the context of buying-shopping disorder.","BACKGROUND


Buying-shopping disorder (BSD) is a severe mental disorder in which individuals lose control over their buying/shopping behavior. It is debated whether BSD shares characteristics with other behavioral addictions. The current study aimed at investigating addiction-related concepts, i.e. cue-reactivity/craving, implicit cognitions, and inhibitory control mechanisms, in the context of BSD.
METHODS


An analog sample of 277 participants completed a cue-reactivity paradigm with shopping-related pictures. To assess implicit cognitions (attentional bias and implicit associations) and inhibitory control, a visual dot probe paradigm, an implicit association test, and an affective shifting task, all with shopping-related and control pictures, were administered. The sequence of the three tasks was randomized across participants. Craving was measured prior and after the cue-reactivity paradigm and after completion of the experimental procedure. BSD severity was assessed using the Pathological Buying Screener (PBS).
RESULTS


Increases in craving during the cue-reactivity paradigm, but decreases after the experimental procedure were observed. Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control. However, we found moderating effects of attentional bias and inhibitory control as well as implicit associations and inhibitory control on the relationship between craving and BSD severity.
DISCUSSION/CONCLUSION


Results emphasize the role of cue-reactivity/craving, implicit cognitions and inhibitory control in the context of BSD. In line with models for behavioral addictions (I-PACE; Brand et al., 2019), the interaction of affective and cognitive biases towards shopping cues and dysfunctional inhibitory control mechanisms seems to explain the pathological engagement in buying/shopping despite negative consequences.",2020,"Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control.",['An analog sample of 277 participants completed a cue-reactivity paradigm with shopping-related pictures'],[],"['Craving', 'BSD severity', 'Craving, attentional bias and implicit cognitions', 'Pathological Buying Screener (PBS', 'implicit cognitions (attentional bias and implicit associations']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",277.0,0.020093,"Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Trotzke', 'Affiliation': 'Department of General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany; Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen, Germany. Electronic address: patrick.trotzke@uni-due.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany; Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Starcke', 'Affiliation': 'SRH Berlin School of Popular Arts, Berlin, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steins-Loeber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106523']
2368,32652834,Ticagrelor monotherapy in patients undergoing percutaneous coronary intervention for bifurcation lesions.,"Ticagrelor monotherapy after a short course of aspirin is emerging as the predominant aspirin-free strategy among patients undergoing percutaneous coronary intervention. In patients included in the GLOBAL-LEADERS trial, the treatment effect of the experimental (dual antiplatelet therapy with aspirin and ticagrelor for 1 month followed by ticagrelor monotherapy) versus control strategy remained consistent irrespective of the presence or absence of coronary bifurcation. Ticagrelor monotherapy represents a safe and effective antiplatelet strategy for the treatment of patients who undergo percutaneous coronary intervention of bifurcation lesions.",2020,Ticagrelor monotherapy represents a safe and effective antiplatelet strategy for the treatment of patients who undergo percutaneous coronary intervention of bifurcation lesions.,"['patients undergoing percutaneous coronary intervention for bifurcation lesions', 'patients undergoing percutaneous coronary intervention', 'patients who undergo percutaneous coronary intervention of bifurcation lesions']","['Ticagrelor monotherapy', 'aspirin and ticagrelor', 'aspirin', 'ticagrelor monotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],,0.0217103,Ticagrelor monotherapy represents a safe and effective antiplatelet strategy for the treatment of patients who undergo percutaneous coronary intervention of bifurcation lesions.,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29082']
2369,32652838,True caring is protecting who is at your side.,"The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions. This technique could be routinely implemented, or selectively chosen when the risk of SB occlusion is high and a two-stent technique is not desirable. A randomized study comparing provisional stenting with the MJBT versus systematic two-stent strategy for the treatment of true bifurcation lesions is warranted.",2020,The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions.,[],"['modified jailed balloon technique (MJBT', 'provisional stenting with the MJBT']",[],[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]",[],,0.021845,The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions.,"[{'ForeName': 'Tiziana Claudia', 'Initials': 'TC', 'LastName': 'Aranzulla', 'Affiliation': 'Interventional Cardiology Unit, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Musumeci', 'Affiliation': 'Cardiology Department, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29081']
2370,32656869,Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.,"BACKGROUND


Oesophageal radiofrequency has been shown to reduce use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs.
AIM


To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn.
METHODS


A randomised, double-blind, sham-controlled multicentre study was designed to assess the efficacy of oesophageal radiofrequency in PPI non-responding patients with heartburn. Patients were included with moderate-to-severe heartburn defined by at least 3 occurrences a week, and not improved by continuous PPI treatment. The primary endpoint was clinical success at week 24, defined by intake of less than 7 PPI doses over the 2 preceding weeks and adequate symptom control determined by the patient.
RESULTS


Sixty two patients were randomised, 29 to the oesophageal radiofrequency group and 33 to the sham group. Intention-to-treat analysis showed that 1/29 (3.4%) and 5/33 (15.1%) achieved the primary endpoint in the oesophageal radiofrequency and sham groups, respectively (NS). There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs. No pH-impedance parameter was associated with clinical response. The occurrence of adverse events was similar in both groups.
CONCLUSION


This sham-controlled, randomised study did not demonstrate any efficacy of oesophageal radiofrequency for the treatment of PPI-refractory heartburn regarding symptom relief and consumption of PPIs. ClinicalTrials.gov NCT01682265.",2020,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","['patients with PPI-refractory heartburn', 'PPI non-responding patients with heartburn', 'patients with gastro-oesophageal reflux disease responding to PPIs']","['oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn', 'oesophageal radiofrequency', 'proton pump inhibitors (PPIs']","['moderate-to-severe heartburn', 'occurrence of adverse events', 'number of days without heartburn, days with PPI consumption', 'clinical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",62.0,0.307362,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Sacher-Huvelin', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coron', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Melchior', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ponchon', 'Affiliation': 'Gastroenterology Department, CHU de Lyon, Hôpital Edouard Herriot, Université de Lyon, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Cholet', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Chabrun', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Vavasseur', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gorbatchef', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zalar', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mion', 'Affiliation': 'Digestive Physiology Department, Hospices Civils de Lyon, Université de Lyon, Inserm U1082 LabTau, Lyon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Robaszkiewicz', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Le Rhun', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leroy', 'Affiliation': 'Methodology and Biostatistics Department, CHU de Nantes, Université de Nantes, Nantes, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paul Galmiche', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Bruley des Varannes', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15936']
2371,32656955,High-Resolution Breast MRI Reconstruction Using a Deep Convolutional Generative Adversarial Network.,"BACKGROUND


A generative adversarial network could be used for high-resolution (HR) medical image synthesis with reduced scan time.
PURPOSE


To evaluate the potential of using a deep convolutional generative adversarial network (DCGAN) for generating HR pre  and HR post  images based on their corresponding low-resolution (LR) images (LR pre  and LR post  ).
STUDY TYPE


This was a retrospective analysis of a prospectively acquired cohort.
POPULATION


In all, 224 subjects were randomly divided into 200 training subjects and an independent 24 subjects testing set.
FIELD STRENGTH/SEQUENCE


Dynamic contrast-enhanced (DCE) MRI with a 1.5T scanner.
ASSESSMENT


Three breast radiologists independently ranked the image datasets, using the DCE images as the ground truth, and reviewed the image quality of both the original LR images and the generated HR images. The BI-RADS category and conspicuity of lesions were also ranked. The inter/intracorrelation coefficients (ICCs) of mean image quality scores, lesion conspicuity scores, and Breast Imaging Reporting and Data System (BI-RADS) categories were calculated between the three readers.
STATISTICAL TEST


Wilcoxon signed-rank tests evaluated differences among the multireader ranking scores.
RESULTS


The mean overall image quality scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.77 ± 0.41 vs. 3.27 ± 0.43 and 4.72 ± 0.44 vs. 3.23 ± 0.43, P < 0.0001, respectively, in the multireader study). The mean lesion conspicuity scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.18 ± 0.70 vs. 3.49 ± 0.58 and 4.35 ± 0.59 vs. 3.48 ± 0.61, P < 0.001, respectively, in the multireader study). The ICCs of the image quality scores, lesion conspicuity scores, and BI-RADS categories had good agreements among the three readers (all ICCs >0.75).
DATA CONCLUSION


DCGAN was capable of generating HR of the breast from fast pre- and postcontrast LR and achieved superior quantitative and qualitative performance in a multireader study.
LEVEL OF EVIDENCE


3 TECHNICAL EFFICACY STAGE: 2.",2020,"The mean overall image quality scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.77 ± 0.41 vs. 3.27 ± 0.43 and 4.72 ± 0.44 vs. 3.23 ± 0.43, P < 0.0001, respectively, in the multireader study).",['224 subjects were randomly divided into 200 training subjects and an independent 24 subjects testing set'],['deep convolutional generative adversarial network (DCGAN'],"['intracorrelation coefficients (ICCs) of mean image quality scores, lesion conspicuity scores, and Breast Imaging Reporting and Data System (BI-RADS) categories', 'ICCs of the image quality scores, lesion conspicuity scores, and BI-RADS categories', 'mean lesion conspicuity scores of the generated HR pre  and HR post', 'mean overall image quality scores of the generated HR pre  and HR post']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",224.0,0.0301274,"The mean overall image quality scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.77 ± 0.41 vs. 3.27 ± 0.43 and 4.72 ± 0.44 vs. 3.23 ± 0.43, P < 0.0001, respectively, in the multireader study).","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liangqiong', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Chunfeng', 'Initials': 'C', 'LastName': 'Lian', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bingqing', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, International Peace Maternity and Child Health Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Ruijin Hospital Luwan Branch, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fuhua', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Dinggang', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'Department of Research and Development, Shanghai United Imaging Intelligence Co.,Ltd., Shanghai, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27256']
2372,32656994,A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study.,"OBJECTIVE


Intensive behavioral obesity treatments face scalability challenges, but evidence is lacking about which treatment components could be cut back without reducing weight loss. The Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (Opt-IN) study applied the Multiphase Optimization Strategy to develop an entirely remotely delivered, technology-supported weight-loss package to maximize the amount of weight loss attainable for ≤$500.
METHODS


Six-month weight loss was examined among adults (N = 562) with BMI ≥ 25 who were randomly assigned to conditions in a factorial experiment crossing five dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training).
RESULTS


About 84.3% of participants completed the final assessment. The treatment package yielding maximum weight loss for ≤$500 included 12 coaching calls, buddy training, and primary care provider progress reports; produced average weight loss of 6.1 kg, with 57.1% losing ≥5% and 51.8% losing ≥7%; and cost $427 per person. The most expensive candidate-treatment component (24 vs. 12 coaching calls) was screened out of the optimized treatment package because it did not increase weight loss.
CONCLUSIONS


Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.",2020,"Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.","['Obesity', 'Six-month weight loss was examined among adults (N\u2009=\u2009562) with BMI\u2009≥\u200925 who']","['dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training']","['average weight loss', 'weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",562.0,0.0217213,"Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.","[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Angela F', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Sara H', 'Initials': 'SH', 'LastName': 'Marchese', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Stump', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'H Gene', 'Initials': 'HG', 'LastName': 'McFadden', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Siddique', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'The Methodology Center, Pennsylvania State University, University Park, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22915']
2373,32657029,"Raltitrexed versus 5-fluorouracil with cisplatin and concurrent radiotherapy for locally advanced nasopharyngeal carcinoma: An open labeled, randomized, controlled, and multicenter clinical trial.","BACKGROUND


This study aimed to compare the efficacy and toxicity of raltitrexed (Saiweijian ®  ) plus cisplatin (SP regimen) and 5-fluorouracil plus cisplatin (FP regimen) as concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).
METHODS


Eligible patients (N = 135) were allocated randomly in a ratio of 1:1 to receive CCRT with either SP or FP. At least 2 cycles of chemotherapy was administrated during radiotherapy. Progression free survival (PFS) was primary endpoint. Secondary endpoints included overall survival (OS), loco-regional relapse free survival (LRRFS), distant metastasis free survival (DMFS) and toxicity.
RESULTS


In this study, 68 patients received SP as CCRT, and 67 received FP. Objective responses were noted in 97.1% of the patients in the SP group and in 97.0% of the patients in the FP group (P = 1.00). At the end of a median 36 months follow-up period, the estimated 3-year PFS rates were 70.1% for SP and 66.6% for FP, respectively. The 3-year LRRFS, DMFS and OS rates were 88.9%, 74.7% and 84.0%, respectively, for the SP group, and 92.3%, 71.0% and 73.7%, respectively, for the FP group. Overall, there was no difference between treatment groups with regard to response or survival. The most frequent acute toxicities monitored in both groups were bone marrow suppression, gastrointestinal side effects and oral mucositis (OM). The overall incidence of grade 3-4 OM in the FP group (47.8%) was higher than in the SP group (11.8%). However, the incidence of other adverse effects observed in both groups was similar (P > .05).
CONCLUSIONS


These data indicate that SP and FP therapies have similar efficacy in treating LA-NPC. The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality. In conclusion, SP was a well tolerated, effective, regimen for LA-NPC treatment.",2020,"The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality.","['locally advanced nasopharyngeal carcinoma', 'Eligible patients (N\xa0=\xa0135', 'patients with locally advanced nasopharyngeal carcinoma (LA-NPC', '68 patients received SP as CCRT, and 67 received']","['raltitrexed (Saiweijian ®  ) plus cisplatin (SP regimen) and 5-fluorouracil plus cisplatin (FP regimen', 'CCRT with either SP or FP', 'FP', 'Raltitrexed versus 5-fluorouracil with cisplatin and concurrent radiotherapy', 'chemotherapy', 'chemoradiotherapy (CCRT']","['acute toxicities', 'incidence of other adverse effects', '3-year PFS rates', 'response or survival', '3-year LRRFS, DMFS and OS rates', 'efficacy and toxicity', 'overall survival (OS), loco-regional relapse free survival (LRRFS), distant metastasis free survival (DMFS) and toxicity', 'tolerable safety profile', 'bone marrow suppression, gastrointestinal side effects and oral mucositis (OM', 'life quality', 'overall incidence of grade 3-4 OM', 'Progression free survival (PFS', 'Objective responses']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",135.0,0.0930863,"The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality.","[{'ForeName': 'Pengwei', 'Initials': 'P', 'LastName': 'Yan', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Department of Radiotherapy, Xuzhou Center Hospital, Xuzhou, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Radiotherapy, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Shengfu', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Bian', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feijiang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Fuzheng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Cancer Institute of Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Hongping', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Director of Department of Radiotherapy Oncology, Nanjing Benq Medicalcenter, Nanjing, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiotherapy, Xuzhou Center Hospital, Xuzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}]",Cancer medicine,['10.1002/cam4.3260']
2374,32659854,Comparing two airway management strategies for moderately sedated patients undergoing awake craniotomy: a single-blinded randomized controlled trial.,"BACKGROUND


In the monitored anesthesia care setting for awake craniotomy (AC), maintaining airway patency in sedated patients remains challenging. This randomized controlled trial aimed to compare the validity of the below-epiglottis transnasal tube insertion (the tip of the tube placed between the epiglottis and vocal cords) and the nasopharyngeal airway (simulated by the above-epiglottis transnasal tube with the tip of the tube placed between the epiglottis and the free edge of the soft palate) with respect to maintaining upper airway patency for moderately sedated patients undergoing AC.
METHODS


Sixty patients scheduled for elective AC were randomized to receive below-epiglottis (n = 30) or above-epiglottis (n = 30) transnasal tube insertion before surgery. Moderate sedation was maintained in the pre- and post-awake phases. The primary outcome was the upper airway obstruction (UAO) remission rate (relieved obstructions after tube insertion/the total number of obstructions before tube insertion).
RESULTS


The UAO remission rate was higher in the below-epiglottis group [100% (12/12) vs 45% (5/11); P = .005]. The tidal volume values monitored through the tube were greater in the below-epiglottis group during the pre-awake phase (P < .001). End-tidal carbon dioxide monitored through the tube was higher in the below-epiglottis group at bone flap removal (P < .001). During the awake phase, patients' ability to speak was not impeded. No patient had serious complications related to the tube.
CONCLUSION


The below-epiglottis tube insertion is a more effective method to maintain upper airway patency than the nasopharyngeal airway for moderately sedated patients undergoing AC.",2020,The UAO remission rate was higher in the below-epiglottis group [100% (12/12) vs 45% (5/11); P = .005].,"['Sixty patients scheduled for elective AC', 'moderately sedated patients undergoing awake craniotomy', 'moderately sedated patients undergoing AC', 'sedated patients']","['nasopharyngeal airway (simulated by the above-epiglottis transnasal tube with the tip of the tube placed between the epiglottis and the free edge of the soft palate) with respect to maintaining upper airway patency', 'below-epiglottis transnasal tube insertion', 'below-epiglottis (n = 30) or above-epiglottis (n = 30) transnasal tube insertion before surgery']","['serious complications', 'End-tidal carbon dioxide monitored through the tube', 'Moderate sedation', 'upper airway obstruction (UAO) remission rate (relieved obstructions after tube insertion/the total number of obstructions before tube insertion', 'tidal volume values', 'UAO remission rate']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0150683', 'cui_str': 'Nasopharyngeal airway device'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0030219', 'cui_str': 'Soft palate structure'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0542276', 'cui_str': 'Respired carbon dioxide monitoring'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0557128,The UAO remission rate was higher in the below-epiglottis group [100% (12/12) vs 45% (5/11); P = .005].,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Meng-Yun', 'Initials': 'MY', 'LastName': 'Tu', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yi-Heng', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xiao-Bing', 'Initials': 'XB', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Huashan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Jin-Song', 'Initials': 'JS', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying-Wei', 'Initials': 'YW', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital of Fudan University, Shanghai, China.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13667']
2375,32659856,Bayesian and heterogeneity of treatment effect analyses of the HOT-ICU trial - a secondary analysis protocol.,"BACKGROUND


The Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial is an ongoing randomised clinical trial exploring the benefits and harms of targeting a lower (8 kPa) versus a higher (12 kPa) arterial oxygenation target in adult patients acutely admitted to the intensive care unit (ICU) with hypoxaemic respiratory failure.
METHODS


This protocol describes a secondary analysis of the primary trial outcome, 90-day all-cause mortality. We will analyse the primary outcome using Bayesian methods, which allows quantification of probabilities of all effect sizes. We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: 1) severity of illness (Sequential Organ Failure Assessment (SOFA) score), 2) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (PaO 2  )/fraction of inspired oxygen (FiO 2  ) ratio), 3) vasopressor requirement (highest noradrenaline dose in the 24 hours prior to randomisation), and 4) plasma lactate concentration (latest prior to randomisation). Additionally, we will perform separate assessments of the treatment effect interaction with each of the baseline parameters above on the continuous scale and present these using conditional effects plots.
CONCLUSIONS


This secondary analysis will aid the interpretation of the HOT-ICU trial by evaluating probabilities of all effect sizes. In addition, we will evaluate whether HTE is present, thus further evaluating benefits and harms of a lower versus a higher oxygenation target in adult ICU patients with acute hypoxaemic respiratory failure.",2020,"We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: 1) severity of illness (Sequential Organ Failure Assessment (SOFA) score), 2) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (","['adult ICU patients with acute hypoxaemic respiratory failure', 'adult patients acutely admitted to the intensive care unit (ICU) with hypoxaemic respiratory failure']",[],"['plasma lactate concentration', 'PaO 2  )/fraction of inspired oxygen (FiO 2  ) ratio', 'severity of illness (Sequential Organ Failure Assessment (SOFA) score), 2) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen ']","[{'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",,0.288622,"We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: 1) severity of illness (Sequential Organ Failure Assessment (SOFA) score), 2) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (","[{'ForeName': 'Thomas Lass', 'Initials': 'TL', 'LastName': 'Klitgaard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Olav Lilleholt', 'Initials': 'OL', 'LastName': 'Schjørring', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care 4131, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13669']
2376,32659874,Impact of Comorbid PTSD on Outcome of Repetitive Transcranial Magnetic Stimulation (TMS) for Veterans With Depression.,"OBJECTIVE


A recent randomized controlled trial of repetitive transcranial magnetic stimulation (TMS) for major depressive disorder (MDD) in veterans raised the question of whether comorbid posttraumatic stress disorder (PTSD) negatively impacted the outcome of TMS in veterans. To address this, a quality database was analyzed to compare outcomes of MDD treated with TMS in veterans with and without comorbid PTSD.
METHODS


The clinical outcomes of all consecutive veterans with MDD treated with TMS at the James A. Haley Veterans' Hospital as outpatients from October 2013 through September 2018 were included. Patients were initially evaluated by an experienced psychiatrist, and the diagnosis of MDD was made by clinical evaluation per DSM-IV-TR/DSM-5 criteria. At the start of treatment, after every 5 treatments, and at the end of treatment, patients were assessed with self-report and clinician-rated scales of depression. All data were abstracted from an existing quality database.
RESULTS


Among the 118 patients treated with TMS for depression, 55 (47%) had comorbid PTSD and 63 (53%) had no comorbid PTSD. Response and remission rates by score on the Montgomery-Asberg Depression Rating Scale were similar between patients with PTSD (52.5% and 40.9%, respectively) and without PTSD (53.8% and 35.6%, respectively). No seizures or persistent adverse effects were observed or reported in either group.
CONCLUSIONS


Comorbid PTSD did not impact the outcome of TMS for depression in this sample of veterans. Future studies should include formal ratings of PTSD to determine if the severity of PTSD affects the outcome.",2020,"Response and remission rates by score on the Montgomery-Asberg Depression Rating Scale were similar between patients with PTSD (52.5% and 40.9%, respectively) and without PTSD (53.8% and 35.6%, respectively).","['Veterans With Depression', 'veterans with and without comorbid PTSD', '118 patients treated with TMS for depression, 55 (47%) had comorbid PTSD and 63 (53%) had no comorbid PTSD', ""consecutive veterans with MDD treated with TMS at the James A. Haley Veterans' Hospital as outpatients from October 2013 through September 2018 were included""]","['Repetitive Transcranial Magnetic Stimulation (TMS', 'TMS', 'repetitive transcranial magnetic stimulation (TMS']","['Montgomery-Asberg Depression Rating Scale', 'Response and remission rates', 'No seizures or persistent adverse effects']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0020030', 'cui_str': 'Veterans Hospitals'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0167948,"Response and remission rates by score on the Montgomery-Asberg Depression Rating Scale were similar between patients with PTSD (52.5% and 40.9%, respectively) and without PTSD (53.8% and 35.6%, respectively).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hernandez', 'Affiliation': ""James A. Haley Veterans' Hospital, Mental Health & Behavioral Sciences (116A), 13000 Bruce B. Downs Blvd, Tampa, FL 33612. mjhernandez@usf.edu.""}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Reljic', 'Affiliation': 'Research Methodology and Biostatistics Core, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Van Trees', 'Affiliation': ""Nursing Service, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Jaffrey', 'Initials': 'J', 'LastName': 'Hashimie', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bajor', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yehl', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'McKenzie', 'Affiliation': ""Research Service, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Burke', 'Affiliation': ""Nursing Service, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Sullivan', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Research Methodology and Biostatistics Core, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Sanchez', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Catalano', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'F Andrew', 'Initials': 'FA', 'LastName': 'Kozel', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13152']
2377,32659891,Effect of Vitamin D Supplementation on Inflammatory Markers in Non-Obese Lebanese Patients with Type 2 Diabetes: A Randomized Controlled Trial.,"BACKGROUND


A low serum 25-hydroxyvitamin D (25(OH) D) concentration has been associated with a higher risk of type 2 diabetes mellitus (T2DM), especially in older people. Our aim in this randomized controlled trial was to evaluate the effect of vitamin D treatment on inflammatory markers in non-obese Lebanese patients with T2DM, living in Beirut, Lebanon.
METHODS


Non-Obese patients with T2DM ( n  = 88), deficient/insufficient in vitamin D, were randomly assigned into one of two groups-a treatment group receiving 30,000 IU cholecalciferol/week for a period of six months, and a placebo group. Serum concentrations of TNF-α, high-sensitivity C-reactive protein (hs-CRP), and Interleukin-6 (IL-6) were the primary outcomes. A homeostatic model of insulin resistance (HOMA-IR) was assessed, in addition to serum concentrations of fasting blood glucose (FBG), HbA1C, (25(OH) D), and PTH.
RESULTS


The vitamin D group showed higher blood levels of (25(OH) D) ( p  < 0.0001), and a significant reduction in hs-CRP and TNF-α concentrations ( p  < 0.0001) compared to placebo. The decrease perceived in IL-6 concentrations was not significant ( p  = 0.1). No significant changes were seen in FBG ( p  = 0.9) and HbA1c levels ( p  = 0.85).
CONCLUSION


Six months of vitamin D supplementation led to a decrease in some inflammatory markers in patients with T2DM. Additional studies with a larger sample and a longer period are advised in this regard. This trial was registered at ClinicalTrial.gov; Identifier number: NCT03782805.",2020,"The vitamin D group showed higher blood levels of (25(OH) D) ( p  < 0.0001), and a significant reduction in hs-CRP and TNF-α concentrations ( p  < 0.0001) compared to placebo.","['patients with T2DM', 'Non-Obese Lebanese Patients with Type 2 Diabetes', 'non-obese Lebanese patients with T2DM, living in Beirut, Lebanon', 'Non-Obese patients with T2DM ( n  = 88), deficient/insufficient in vitamin D']","['25-hydroxyvitamin D', 'vitamin D treatment', 'Vitamin D Supplementation', 'vitamin D', 'vitamin D supplementation', 'placebo']","['Serum concentrations of TNF-α, high-sensitivity C-reactive protein (hs-CRP), and Interleukin-6 (IL-6', 'FBG', 'IL-6 concentrations', 'blood levels of (25(OH) D', 'hs-CRP and TNF-α concentrations', 'Inflammatory Markers', 'inflammatory markers', 'serum concentrations of fasting blood glucose (FBG), HbA1C, (25(OH) D), and PTH', 'HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",,0.465639,"The vitamin D group showed higher blood levels of (25(OH) D) ( p  < 0.0001), and a significant reduction in hs-CRP and TNF-α concentrations ( p  < 0.0001) compared to placebo.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'El Hajj', 'Affiliation': 'Department of Nutrition, Faculty of Natural Sciences, Lebanese American University, Beirut 1102 2801, Lebanon.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Walrand', 'Affiliation': ""Unité de Nutrition Humaine, France Clermont Université, Université d'Auvergne, INRA, UMR 1019, UNH, CRNH Auvergne, 63009 Clermont-Ferrand, France.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Helou', 'Affiliation': 'Department of Medicine, School of Medicine, Lebanese American University, Beirut 1102, Lebanon.'}, {'ForeName': 'Kaissar', 'Initials': 'K', 'LastName': 'Yammine', 'Affiliation': 'Department of Orthopedic Surgery, Lebanese American University School of Medecine-Rizk Hospital, Beirut, Lebanon-Center for Evidence-Based Anatomy, Sports & Orthopedic Research, Jdeideh 1102, Lebanon.'}]",Nutrients,['10.3390/nu12072033']
2378,32660041,"Effects of Rapid Recovery on Alcohol Hangover Severity: A Double-Blind, Placebo-Controlled, Randomized, Balanced Crossover Trial.","The aim of this study was to evaluate the efficacy of putative hangover treatment, Rapid Recovery, in mitigating alcohol hangover (AH) symptom severity. Using a double-blind, randomized, placebo-controlled, balanced crossover design, 20 participants attended the laboratory for two evenings of alcohol consumption, each followed by morning assessments of AH severity. Participants were administered Rapid Recovery and placebo on separate visits. In the first testing visit, participants self-administered alcoholic beverages of their choice, to a maximum of 1.3 g/kg alcohol. Drinking patterns were recorded and replicated in the second evening testing visit. In the morning visits, AH severity was assessed using questionnaires measuring AH symptom severity and sleep quality, computerized assessments of cognitive functioning as well as levels of blood biomarkers of liver function (gamma-glutamyl transferase (GGT)) and inflammation (high-sensitive C-reactive protein (hs-CRP)). There were no differences in the blood alcohol concentrations (BAC) obtained in the Rapid Recovery (mean = 0.096%) and placebo (mean = 0.097%) conditions. Participants reported significantly greater sleep problems in the Rapid Recovery compared to placebo condition, although this difference was no longer significant following Bonferroni's correction. There were no other significant differences between Rapid Recovery and placebo. These data suggest that Rapid Recovery has no significant effect on alcohol hangover nor on associated biomarkers.",2020,There were no differences in the blood alcohol concentrations (BAC) obtained in the Rapid Recovery (mean = 0.096%) and placebo (mean = 0.097%) conditions.,"['20 participants attended the laboratory for two evenings of alcohol consumption, each followed by morning assessments of AH severity']","['Placebo', 'placebo']","['questionnaires measuring AH symptom severity and sleep quality, computerized assessments of cognitive functioning as well as levels of blood biomarkers of liver function (gamma-glutamyl transferase (GGT)) and inflammation (high-sensitive C-reactive protein (hs-CRP', 'sleep problems', 'Alcohol Hangover Severity', 'mitigating alcohol hangover (AH) symptom severity', 'blood alcohol concentrations (BAC']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0393756', 'cui_str': 'Hangover'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0393756', 'cui_str': 'Hangover'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}]",20.0,0.271567,There were no differences in the blood alcohol concentrations (BAC) obtained in the Rapid Recovery (mean = 0.096%) and placebo (mean = 0.097%) conditions.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ayre', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Joris C', 'Initials': 'JC', 'LastName': 'Verster', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9072175']
2379,32660126,Feasibility and Preliminary Effectiveness of a Tele-Prehabilitation Program in Esophagogastric Cancer Patients.,"Tele-rehabilitation provides better access to healthcare services and optimizes exercise adherence. However, its feasibility and effectiveness are unknown in the preoperative period in esophagogastric cancer patients. We aimed to assess the feasibility and the preliminary effects of a ""tele-prehabilitation"" program in esophagogastric cancer patients requiring surgery. Enrolled participants performed an internet-based tele-prehabilitation including aerobic, resistance and inspiratory muscle training over 2-4 weeks. The primary outcome was feasibility, measured in terms of recruitment, retention and attendance rates, adverse events and patient satisfaction. Secondary outcomes (functional exercise capacity, fatigue, quality of life, anxiety and depression) were assessed at baseline, presurgery, and 4 and 12 weeks postsurgery. Among the 24 eligible subjects, 23 were enrolled, 22 performed the intervention and 15 completed the study. Recruitment and retention rates were both 96%. Attendances to aerobic and resistance sessions and inspiratory muscle training were 77% and 68%, respectively. No adverse events occurred, and the satisfaction was excellent. After prehabilitation, participants significantly improved fatigue ( p  = 0.039), quality of life ( p  = 0.009), physical well-being ( p  = 0.034), emotional well-being ( p  = 0.005) and anxiety ( p  = 0.044). This study demonstrated the feasibility of a tele-prehabilitation in esophagogastric cancer patients undergoing surgery, with a high recruitment rate, retention rate and satisfaction, a good attendance to exercise sessions and no exercise-related adverse events.",2020,"After prehabilitation, participants significantly improved fatigue ( p  = 0.039), quality of life ( p  = 0.009), physical well-being ( p  = 0.034), emotional well-being ( p  = 0.005) and anxiety ( p  = 0.044).","['Esophagogastric Cancer Patients', 'esophagogastric cancer patients requiring surgery', 'esophagogastric cancer patients undergoing surgery, with a high recruitment rate, retention rate and satisfaction, a good attendance to exercise sessions and no exercise-related adverse events', 'esophagogastric cancer patients', '24 eligible subjects, 23 were enrolled, 22 performed the intervention and 15 completed the study']","['internet-based tele-prehabilitation including aerobic, resistance and inspiratory muscle training over 2-4 weeks', 'Tele-Prehabilitation Program', 'tele-prehabilitation"" program']","['quality of life', 'fatigue', 'anxiety', 'Recruitment and retention rates', 'recruitment, retention and attendance rates, adverse events and patient satisfaction', 'Attendances to aerobic and resistance sessions and inspiratory muscle training', 'adverse events', 'Secondary outcomes (functional exercise capacity, fatigue, quality of life, anxiety and depression']","[{'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",23.0,0.0511008,"After prehabilitation, participants significantly improved fatigue ( p  = 0.039), quality of life ( p  = 0.009), physical well-being ( p  = 0.034), emotional well-being ( p  = 0.005) and anxiety ( p  = 0.044).","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Piraux', 'Affiliation': 'Pôle de Neuro Musculo Skeletal Lab, Pôle de Pneumologie, ORL & Dermatologie, Institut de Recherche Expérimentale et Clinique, Clinical Neuroscience, Institute of Neurosciences, Université Catholique de Louvain, 1200 Brussels, Belgium.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Caty', 'Affiliation': 'Pôle de Neuro Musculo Skeletal Lab, Institut de Recherche Expérimentale et Clinique, Clinical Neuroscience, Institute of Neurosciences, Université Catholique de Louvain, Service de Médecine Physique et Réadaptation, Cliniques Universitaires Saint-Luc, 1200 Brussels, Belgium.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Pôle de Pneumologie, ORL & Dermatologie, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Haute Ecole Léonard de Vinci, PARNASSE-ISEI, Secteur de kinésithérapie, Service de Pneumologie, Cliniques Universitaires Saint-Luc, 1200 Brussels, Belgium.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': 'Institute of Applied Health Sciences, Epidemiology Group, University of Aberdeen, NHS Grampian, Department of Anaesthetics, Aberdeen AB25 2ZD, UK: forgetpatrice@yahoo.fr.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Deswysen', 'Affiliation': 'Upper Gastrointestinal Surgery Unit, Cliniques Universitaires Saint-Luc, 1200 Brussels, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9072176']
2380,32660159,The Effectiveness of a Dyadic Pain Management Program for Community-Dwelling Older Adults with Chronic Pain: A Pilot Randomized Controlled Trial.,"BACKGROUND


Chronic pain is a major health problem among older adults and their informal caregivers, which has negative effects on their physical and psychological status. The dyadic pain management program (DPMP) is provided to community-dwelling older adults and informal caregivers to help the dyads reduce pain symptoms, improve the quality of life, develop good exercise habits, as well as cope and break the vicious circle of pain.
METHODS


A pilot randomized controlled trial was designed and all the dyads were randomly divided into two groups: the DPMP group and control group. Dyads in the DPMP group participated in an 8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information.
RESULTS


In total, 64 dyads participated in this study. For baseline comparisons, no significant differences were found between the two groups. After the interventions, the pain score was significantly reduced from 4.25 to 2.57 in the experimental group, respectively. In the repeated measures ANOVA, the differences in pain score (F = 107.787,  p  < 0.001,  d  = 0.777) was statistically significant for the group-by-time interaction. After the interventions, the experimental group participants demonstrated significantly higher pain self-efficacy compared with the control group (F = 80.535,  p  < 0.001,  d  = 0.722). Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
CONCLUSIONS


These results provide preliminary support for the effectiveness of a DPMP for relieving the symptoms of chronic pain among the elderly.",2020,"Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
","['Community-Dwelling Older Adults with Chronic Pain', 'older adults and their informal caregivers', '64 dyads participated in this study', 'community-dwelling older adults and informal caregivers']","['dyadic pain management program (DPMP', 'DPMP', 'Dyadic Pain Management Program', '8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information', 'DPMP group and control group']","['exercise time', 'pain score', 'pain self-efficacy']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",64.0,0.025096,"Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
","[{'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17144966']
2381,32660211,Manual versus automated image fusion of real-time ultrasonography and MR/CT images for radiofrequency ablation of hepatic tumors: Results of a randomized prospective trial.,"PURPOSE


To compare the technical parameters of imaging fusion and clinical outcomes of manual and automatic image fusion techniques of ultrasonography and MRI/CT for radiofrequency ablation (RFA) of hepatic tumors.
METHODS


Seventy consecutive patients (M:F=47:23, 67.1±10.9 years old) who performed RFA for hepatic tumors were prospectively enrolled and randomly assigned to manual or automatic registration group. Two operators performed RFA with one of two imaging fusion techniques. Technical parameters including registration error, time required for image registration, number of point registrations and clinical outcomes including technical success, technical effectiveness, local tumor progression (LTP) free survival and progression free survival (PFS) were compared.
RESULTS


Thirty-five patients with hepatocellular carcinoma were treated using the automatic registration (automatic group) and 34 patients with hepatocellular carcinoma and a patient with colon cancer liver metastasis were treated using the manual registration (manual group). The registration error, time required for registration and number of point registrations were 5.7±4.3 mm, 147.8±78.2 sec and 3.26±1.20 for automatic group, and 6.3±5.0 mm, 150.3±89.7 sec and 3.20±1.13 for manual group, respectively, without significant difference. Technical success and effectiveness rate were both 97.1% for automatic group and both 100.0% for manual group without any significant difference. The LTP-free survival and PFS between both groups (28.3 and 21.2 months for automatic group, and 29.0 and 24.9 months for manual group, respectively) showed no significant difference during the mean follow-up period of 20.1 months.
CONCLUSION


The performance and clinical outcomes of the manual and automatic image fusion are comparable for RFA of hepatic tumors.",2020,Technical success and effectiveness rate were both 97.1% for automatic group and both 100.0% for manual group without any significant difference.,"['34 patients with hepatocellular carcinoma and a patient with colon cancer liver metastasis', 'hepatic tumors', 'Thirty-five patients with hepatocellular carcinoma', 'Seventy consecutive patients (M:F=47:23, 67.1±10.9 years old) who performed RFA for hepatic tumors']","['automatic registration (automatic group', 'manual or automatic registration group', 'Manual versus automated image fusion of real-time ultrasonography and MR/CT images', 'ultrasonography and MRI/CT for radiofrequency ablation (RFA']","['Technical success and effectiveness rate', 'registration error, time required for registration and number of point registrations', 'LTP-free survival and PFS', 'registration error, time required for image registration, number of point registrations and clinical outcomes including technical success, technical effectiveness, local tumor progression (LTP) free survival and progression free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0023903', 'cui_str': 'Neoplasm of liver'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449956', 'cui_str': 'Number of points'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",70.0,0.0620668,Technical success and effectiveness rate were both 97.1% for automatic group and both 100.0% for manual group without any significant difference.,"[{'ForeName': 'Moon Hyung', 'Initials': 'MH', 'LastName': 'Choi', 'Affiliation': ""Department of Radiology, Eunpyeong St.Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Joon-Il', 'Initials': 'JI', 'LastName': 'Choi', 'Affiliation': ""Department of Radiology, Seoul St.Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': ""Department of Radiology, Eunpyeong St.Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, Korea.""}]","Ultrasonography (Seoul, Korea)",['10.14366/usg.20052']
2382,32660260,Efficacy of an Adjunctive Electrophysiological Test-Guided Left Atrial Posterior Wall Isolation in Persistent Atrial Fibrillation Without a Left Atrial Low Voltage Area.,"Background  - Electrical remodeling precedes structural remodeling. In adjunctive left atrial (LA) low-voltage area (LVA) ablation to pulmonary vein isolation of atrial fibrillation (AF), LA areas without LVA have not been targeted for ablation. We studied the effect of adjunctive LA posterior wall isolation (PWI) on persistent AF without LA-LVA according to electrophysiological testing (EP test).  Methods  - We examined consecutive persistent AF patients with (n=33) and without (n=111) LA-LVA. Patients without LA-LVA were randomly assigned to EP test-guided (n=57) and control (n=54) groups. In the EP test-guided group, an adjunctive PWI was performed in those with positive results (PWI subgroup; n=24), but not in those with negative results (n=33). The criteria for positive EP tests were an effective refractory period (ERP)≤180 ms, ERP>20 ms shorter than the other sites, and/or induction of AF/atrial tachycardia (AT) during measurements. LVA ablation was performed in the LA-LVA patients.  Results  - During the follow-up period (62 ± 33 weeks), the EP test-guided group had significantly lower recurrence rates (19%,11/57 vs. 41%, 22/54, p=0.012) and higher Kaplan-Meier AF/AT-free survival curve rates than the control group (p=0.01). No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed. Therefore, PWI for positive EP tests reduced the AF/AT recurrence in the EP test-guided group. A stepwise Cox proportional hazard analyses identified EP test-guided ablation as a factor reducing the recurrence rate. The recurrence rates in the LA-LVA ablation group and EP test-guided group were similar.  Conclusions  - This pilot study proposed that an EP test-guided adjunctive PWI of persistent AF without LA-LVA potentially reduced AF/AT recurrences. The results suggest that there is an AF substrate in the LA with altered electrophysiological function even when there is no LA-LVA.",2020,No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed.,"['Patients without LA-LVA', 'consecutive persistent AF patients with (n=33) and without (n=111) LA-LVA']","['Adjunctive Electrophysiological Test-Guided Left Atrial Posterior Wall Isolation', 'adjunctive LA posterior wall isolation (PWI', 'LA-LVA ablation', 'EP test-guided', 'adjunctive left atrial (LA) low-voltage area (LVA) ablation', 'LVA ablation']","['recurrence and AF/AT-free survival curve rates', 'AF/AT recurrence', 'recurrence rates', 'recurrence rate', 'higher Kaplan-Meier AF/AT-free survival curve rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0273246,No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed.,"[{'ForeName': 'Hirosuke', 'Initials': 'H', 'LastName': 'Yamaji', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Higashiya', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Hina', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawamura', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Shigeshi', 'Initials': 'S', 'LastName': 'Kamikawa', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirohata', 'Affiliation': 'Department of Medical Technology, Okayama University Graduate School of Health Sciences, Okayama, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Kusachi', 'Affiliation': 'Department of Medical Technology, Okayama University Graduate School of Health Sciences, Okayama, Japan.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008191']
2383,32660261,Scapular exercise combined with cognitive functional therapy is more effective at reducing chronic neck pain and kinesiophobia than scapular exercise alone: a randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the effectiveness of scapular exercises alone and combined with cognitive functional therapy in treating patients with chronic neck pain and scapular downward rotation impairment.
DESIGN


Single-blind randomized controlled trial.
SETTING


Outpatient.
SUBJECTS


A total of 72 patients (20-45 years old) with chronic neck pain were studied.
INTERVENTION


Allocation was undertaken into three groups: scapular exercise ( n  = 24), scapular exercise with cognitive functional therapy ( n  = 24) and control ( n  = 24) groups. Each programme lasted three times a week for six weeks.
MAIN OUTCOMES


The primary outcome measure was pain intensity measured by the visual analogue scale scores. The secondary outcome measures included kinesiophobia and muscles activity.
RESULTS


Statistically significant differences in pain intensity were found when multidisciplinary physiotherapy group including a cognitive functional approach was compared with the scapular exercise alone group at six weeks (effect size (95% CI) = -2.56 (-3.32 to -1.80);  P  = 0.019). Regarding kinesiophobia, a significant between-group difference was observed at six-week (effect size (95% CI) = -2.20 (-2.92 to -1.49);  P  = 0.005), with the superiority of effect in multidisciplinary physiotherapy group. A significant between-group differences was observed in muscle activity. Also, there were significant between-group differences favouring experimental groups versus control.
CONCLUSION


A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.",2020,"A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.","['participants with chronic neck pain', 'A total of 72 patients (20-45\u2009years old) with chronic neck pain were studied', 'patients with chronic neck pain and scapular downward rotation impairment', 'Outpatient']","['scapular exercise alone', 'scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone', 'Scapular exercise combined with cognitive functional therapy', 'scapular exercises alone and combined with cognitive functional therapy', 'scapular exercise ( n \u2009=\u200924), scapular exercise with cognitive functional therapy']","['pain intensity, kinesiophobia and muscle activation', 'muscle activity', 'pain intensity', 'chronic neck pain and kinesiophobia', 'kinesiophobia and muscles activity', 'pain intensity measured by the visual analogue scale scores']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",72.0,0.138117,"A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.","[{'ForeName': 'Norollah', 'Initials': 'N', 'LastName': 'Javdaneh', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Sadredin', 'Initials': 'S', 'LastName': 'Shojaedin', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hadadnezhad', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}]",Clinical rehabilitation,['10.1177/0269215520941910']
2384,32660264,"Resistance Training Impact on Mobility, Muscle Strength and Lean Mass in Pancreatic Cancer Cachexia: A Randomized Controlled Trial.","OBJECTIVE


To determine the efficacy of a three-month resistance training programme on the mobility, muscle strength and lean body mass of patients with pancreatic cancer-induced cachexia.
DESIGN


Randomized controlled trial.
SETTING


Elsahel Teaching Hospital, outpatient clinic of the Faculty of Physical Therapy, Cairo, Egypt.
PARTICIPANTS


Patients with pancreatic cancer-induced cachexia.
INTERVENTIONS


Participants were randomized to the resistance training group ( n  = 20) and control group ( n  = 20).
MAIN MEASURES


Outcomes including mobility, muscle strength and lean body mass were measured at baseline, three months after surgical resection and 12 weeks after intervention.
RESULTS


The mean (SD) age was 51.9 (5.03) years and body mass index was 21.1 (1.13) kg/m²; 65% of patients were male. Compared to the control group, the resistance training group showed significant improvement in mobility: 400-m walk performance (270.3-256.9 seconds vs 266.4-264.2 seconds, respectively) and chair rise (13.82-12.53 seconds vs 13.77-13.46 seconds, respectively). Similarly, muscle strength was also significantly improved in the resistance training group than in the control group; we observed increase in peak torque of knee extensors ( P  = 0.004), elbow flexors ( P  = 0.001) and elbow extensors, improvement in lean mass of the upper limb (6.28-6.46 kg vs 6.31-6.23 kg, respectively) and lower limb (16.31-16.58 kg vs 16.4-16.31 kg, respectively).
CONCLUSION


A three-month resistance training improved the mobility of patients with pancreatic cancer-induced cachexia. Muscle strength and lean body mass also improved.",2020,"Compared to the control group, the resistance training group showed significant improvement in mobility: 400-m walk performance (270.3-256.9 seconds vs 266.4-264.2 seconds, respectively) and chair rise (13.82-12.53 seconds vs 13.77-13.46 seconds, respectively).","['Patients with pancreatic cancer-induced cachexia', 'The mean (SD) age was 51.9 (5.03) years and body mass index was 21.1 (1.13)\u2009kg/m²; 65% of patients were male', 'Pancreatic Cancer Cachexia', 'patients with pancreatic cancer-induced cachexia', 'Elsahel Teaching Hospital, outpatient clinic of the Faculty of Physical Therapy, Cairo, Egypt']","['resistance training programme', 'resistance training group ( n \u2009=\u200920) and control group ( n \u2009=\u200920', 'Resistance Training', 'resistance training']","['lower limb', 'elbow flexors', 'mobility: 400-m walk performance', 'mobility, muscle strength and lean body mass', 'muscle strength', 'chair rise', 'Mobility, Muscle Strength and Lean Mass', 'peak torque of knee extensors', 'Muscle strength and lean body mass', 'elbow extensors, improvement in lean mass of the upper limb']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]",,0.0445473,"Compared to the control group, the resistance training group showed significant improvement in mobility: 400-m walk performance (270.3-256.9 seconds vs 266.4-264.2 seconds, respectively) and chair rise (13.82-12.53 seconds vs 13.77-13.46 seconds, respectively).","[{'ForeName': 'FatmaAlzahraa H', 'Initials': 'FH', 'LastName': 'Kamel', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Maged A', 'Initials': 'MA', 'LastName': 'Basha', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Qassim, Saudi Arabia.'}, {'ForeName': 'Ashwag S', 'Initials': 'AS', 'LastName': 'Alsharidah', 'Affiliation': 'Department of Physiology, College of Medicine, Qassim University, Buraidah, Qassim, Saudi Arabia.'}, {'ForeName': 'Amr B', 'Initials': 'AB', 'LastName': 'Salama', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",Clinical rehabilitation,['10.1177/0269215520941912']
2385,32660432,Cost-effectiveness analysis of repeated self-sampling for HPV testing in primary cervical screening: a randomized study.,"BACKGROUND


Human papillomavirus (HPV) testing is recommended in primary cervical screening to improve cancer prevention. An advantage of HPV testing is that it can be performed on self-samples, which could increase population coverage and result in a more efficient strategy to identify women at risk of developing cervical cancer. Our objective was to assess whether repeated self-sampling for HPV testing is cost-effective in comparison with Pap smear cytology for detection of cervical intraepithelial neoplasia grade 2 or more (CIN2+) in increasing participation rate in primary cervical screening.
METHODS


A cost-effectiveness analysis (CEA) was performed on data from a previously published randomized clinical study including 36,390 women aged 30-49 years. Participants were randomized either to perform repeated self-sampling of vaginal fluid for HPV testing (n = 17,997, HPV self-sampling arm) or to midwife-collected Pap smears for cytological analysis (n = 18,393, Pap smear arm).
RESULTS


Self-sampling for HPV testing led to 1633 more screened women and 107 more histologically diagnosed CIN2+ at a lower cost vs. midwife-collected Pap smears (€ 229,446 vs. € 782,772).
CONCLUSIONS


This study resulted in that repeated self-sampling for HPV testing increased participation and detection of CIN2+ at a lower cost than midwife-collected Pap smears in primary cervical screening. Offering women a home-based self-sampling may therefore be a more cost-effective alternative than clinic-based screening.
TRIAL REGISTRATION


Not registered since this trial is a secondary analysis of an earlier published study (Gustavsson et al., British journal of cancer. 118:896-904, 2018).",2020,"Self-sampling for HPV testing led to 1633 more screened women and 107 more histologically diagnosed CIN2+ at a lower cost vs. midwife-collected Pap smears (€ 229,446 vs. € 782,772).
","['36,390 women aged 30-49\u2009years', '1633 more screened women and 107 more histologically diagnosed CIN2+ at a lower cost vs. midwife-collected Pap smears (€ 229,446 vs. € 782,772', 'primary cervical screening']","['repeated self-sampling for HPV testing', 'repeated self-sampling of vaginal fluid for HPV testing (n\u2009=\u200917,997, HPV self-sampling arm) or to midwife-collected Pap smears for cytological analysis (n\u2009=\u200918,393, Pap smear arm']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0392908', 'cui_str': 'Vaginal secretion'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],36390.0,0.106645,"Self-sampling for HPV testing led to 1633 more screened women and 107 more histologically diagnosed CIN2+ at a lower cost vs. midwife-collected Pap smears (€ 229,446 vs. € 782,772).
","[{'ForeName': 'Riina', 'Initials': 'R', 'LastName': 'Aarnio', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, 751 85, Uppsala, Sweden. riina.aarnio@kbh.uu.se.""}, {'ForeName': 'Ellinor', 'Initials': 'E', 'LastName': 'Östensson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Tomtebodavägen 18A, 171 77, Stockholm, Sweden.""}, {'ForeName': 'Matts', 'Initials': 'M', 'LastName': 'Olovsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, 751 85, Uppsala, Sweden.""}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gustavsson', 'Affiliation': 'Department of Immunology, Genetics, and Pathology, Biomedical Center, SciLifeLab Uppsala, Uppsala University, Box 815, 75108, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Gyllensten', 'Affiliation': 'Department of Immunology, Genetics, and Pathology, Biomedical Center, SciLifeLab Uppsala, Uppsala University, Box 815, 75108, Uppsala, Sweden.'}]",BMC cancer,['10.1186/s12885-020-07085-9']
2386,32660475,Evidence of high bed net usage from a list randomization experiments in rural Gambia.,"BACKGROUND


Recording behaviours that have the potential to impact health can be doubly challenging if the behaviour takes place in private spaces that cannot be observed directly, and where respondents answer what they think the recorder may want to hear. Sleeping under a long-lasting insecticidal net (LLIN) is an important intervention for malaria prevention, yet it is difficult to gauge the extent to which coverage (how many nets are in the community) differs from usage (how many people actually sleep under a net). List randomization, a novel method which partially obscures respondents' answers to sensitive questions, was employed to estimate LLIN usage in The Gambia.
METHODS


802 heads-of-household from 15 villages were recruited into a randomized controlled trial assessing the effect of a housing intervention on malaria. These houses were randomly assigned to a housing intervention versus control, with stratification by village so as to ensure balance between arms. From these, 125 households (63 intervention, 52 control) were randomly selected for participation in the list randomization experiment, along with 68 households from the same villages but which were not part of the housing improvement study, resulting in a total of 196 households for the list randomization experiment. Approximately half (n = 97) of the 196 study participants were randomly assigned to the control group and received a four-question list about non-sensitive behaviours; the intervention group (n = 99) received the same list, with the addition of one question on a sensitive behaviour: whether or not they had used a bed net the previous night. Participants were read the list of questions and then said how many of the statements were true. Bed net usage was estimated by calculating the difference in means between the number of affirmative responses between the two groups.
RESULTS


The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI 2.50-2.70), compared with 3.68 (95% CI 3.59-3.78) in the intervention group. Such difference (1.08; 95% CI 94.9-100%) suggests near universal bed net usage.
CONCLUSIONS


Bed net usage by household heads in these rural villages was found to be high. Though not entirely unexpected given other studies' estimates of high bed net usage in the area, the list randomization method should be further validated in an area with lower coverage.",2020,"The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI 2.50-2.70), compared with 3.68 (95% CI 3.59-3.78) in the intervention group.","['125 households (63 intervention, 52 control) were randomly selected for participation in the list randomization experiment, along with 68 households from the same villages but which were not part of the housing improvement study, resulting in a total of 196 households for the list randomization experiment', 'rural Gambia', 'Approximately half (n\u2009=\u200997) of the 196 study participants', '802 heads-of-household from 15 villages']","['control group and received a four-question list about non-sensitive behaviours; the intervention group', 'Sleeping under a long-lasting insecticidal net (LLIN', 'housing intervention', 'housing intervention versus control']",['mean number of affirmative responses'],"[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0016993', 'cui_str': 'The Gambia'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0018677', 'cui_str': 'Head of Household'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0020056', 'cui_str': 'Housed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",196.0,0.0788638,"The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI 2.50-2.70), compared with 3.68 (95% CI 3.59-3.78) in the intervention group.","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Brew', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain. joebrew@gmail.com.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pinder', 'Affiliation': 'Medical Research Council Unit, The Gambia at the London, School of Hygiene and Tropical Medicine, PO Box 273, Banjul, The Gambia.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit, The Gambia at the London, School of Hygiene and Tropical Medicine, PO Box 273, Banjul, The Gambia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lindsay', 'Affiliation': 'Department of Biosciences, Durham University, Stockton Road, Durham, DH1 3LE, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Medical Research Council Unit, The Gambia at the London, School of Hygiene and Tropical Medicine, PO Box 273, Banjul, The Gambia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sicuri', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}]",Malaria journal,['10.1186/s12936-020-03322-5']
2387,32660488,Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD) for resection of non-pedunculated rectal lesions (TRIASSIC study): study protocol of a European multicenter randomised controlled trial.,"BACKGROUND


In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden.
METHODS


Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior.
DISCUSSION


This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future.
TRIAL REGISTRATION


Netherlands Trial Register, NL7083 , 06 July 2018.",2020,This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions.,"['resection of non-pedunculated rectal lesions (TRIASSIC study', 'Patients with non-pedunculated lesions >\u20092\u2009cm, where the bulk of the lesion is below 15\u2009cm from the anal verge', '15 hospitals in the Netherlands']","['TAMIS', 'Transanal Minimally Invasive Surgery (TAMIS', 'Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD', 'TAMIS and ESD']","['1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12\u2009months; 4) Surgical referral rate at 12\u2009months; 5) Complication rate; 6) Local recurrence rate', 'local recurrence rate', 'cumulative local recurrence rate']","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0577034', 'cui_str': 'Lesion of rectum'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C4505038', 'cui_str': 'TAMIS'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.188771,This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions.,"[{'ForeName': 'Nik', 'Initials': 'N', 'LastName': 'Dekkers', 'Affiliation': 'Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. n.dekkers@lumc.nl.'}, {'ForeName': 'Jurjen J', 'Initials': 'JJ', 'LastName': 'Boonstra', 'Affiliation': 'Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Leon M G', 'Initials': 'LMG', 'LastName': 'Moons', 'Affiliation': 'Department of Gastroenterology & Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Hompes', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Bastiaansen', 'Affiliation': 'Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjun D', 'Initials': 'AD', 'LastName': 'Koch', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bas L A M', 'Initials': 'BLAM', 'LastName': 'Weusten', 'Affiliation': 'Department of Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Neijenhuis', 'Affiliation': 'Department of Surgery, Alrijne hospital, Leiderdorp, The Netherlands.'}, {'ForeName': 'Marinke', 'Initials': 'M', 'LastName': 'Westerterp', 'Affiliation': 'Department of Surgery, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Medical Decision Making & Quality of Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Alexandra M J', 'Initials': 'AMJ', 'LastName': 'Langers', 'Affiliation': 'Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Jolein', 'Initials': 'J', 'LastName': 'van der Kraan', 'Affiliation': 'Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Alkhalaf', 'Affiliation': 'Department of Gastroenterology & Hepatology, Isala hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Jonathan Y L', 'Initials': 'JYL', 'LastName': 'Lai', 'Affiliation': 'Department of Gastroenterology & Hepatology, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ter Borg', 'Affiliation': 'Department of Gastroenterology & Hepatology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Fabry', 'Affiliation': 'Department of Surgery, Bravis Hospital, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Halet', 'Affiliation': 'Department of Gastroenterology & Hepatology, Bravis Hospital, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Matthijs P', 'Initials': 'MP', 'LastName': 'Schwartz', 'Affiliation': 'Departmet of Gastroenterology & Hepatology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Wouter B', 'Initials': 'WB', 'LastName': 'Nagengast', 'Affiliation': 'Department of Gastroenterology & Hepatology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jan Willem A', 'Initials': 'JWA', 'LastName': 'Straathof', 'Affiliation': 'Department of Gastroenterology & Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Rogier W R', 'Initials': 'RWR', 'LastName': 'Ten Hove', 'Affiliation': 'Department of Gastroenterology & Hepatology, Alrijne Hospital, Leiderdorp, The Netherlands.'}, {'ForeName': 'Leendert H', 'Initials': 'LH', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Gastroenterology & Hepatology, Hagaziekenhuis, The Hague, The Netherlands.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Hoff', 'Affiliation': 'Department of Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Eric J Th', 'Initials': 'EJT', 'LastName': 'Belt', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'David D E', 'Initials': 'DDE', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Surgery, Elisabeth-TweeSteden Ziekenhuis, Eindhoven, The Netherlands.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Hadithi', 'Affiliation': 'Department of Gastroenterology & Hepatology, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Morreau', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Erienne M V', 'Initials': 'EMV', 'LastName': 'de Cuba', 'Affiliation': 'Pathan B.V. - Pathology Laboratorium, Rotterdam, The Netherlands.'}, {'ForeName': 'Jeroen W A', 'Initials': 'JWA', 'LastName': 'Leijtens', 'Affiliation': 'Department of Surgery, Laurentius Hospital, Roermond, The Netherlands.'}, {'ForeName': 'Hans F A', 'Initials': 'HFA', 'LastName': 'Vasen', 'Affiliation': 'Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'van Leerdam', 'Affiliation': 'Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Eelco J R', 'Initials': 'EJR', 'LastName': 'de Graaf', 'Affiliation': 'Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'Pascal G', 'Initials': 'PG', 'LastName': 'Doornebosch', 'Affiliation': 'Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'James C H', 'Initials': 'JCH', 'LastName': 'Hardwick', 'Affiliation': 'Department of Gastroenterology & Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}]",BMC gastroenterology,['10.1186/s12876-020-01367-z']
2388,32660496,"The impact of an audience response system on a summative assessment, a controlled field study.","BACKGROUND


Audience response systems allow to activate the audience and to receive a direct feedback of participants during lectures. Modern systems do not require any proprietary hardware anymore. Students can directly respond on their smartphone. Several studies reported about a high level of satisfaction of students when audience response systems are used, however their impact on learning success is still unclear.
METHODS


In order to evaluate the impact of an audience response system on the learning success we implemented the audience response system eduVote into a seminar series and performed a controlled crossover study on its impact on assessments. One hundred fifty-four students in nine groups were taught the same content. In four groups, eduVote was integrated for the first topic while five groups were taught this topic without the audience response systems. For a second topic, the groups were switched: Those groups who were taught before using eduVote were now taught without the audience response system and vice versa. We then analysed the impact of the audience response system on the students' performance in a summative assessment and specifically focused on questions dealing with the topic, for which the audience response system was used during teaching. We further assessed the students' perception on the use of eduVote using questionnaires.
RESULTS


In our controlled crossover study we could not confirm an impact of the audience response system eduVote on long-term persistence i.e. the students' performance in the summative assessment. Our evaluation revealed that students assessed the use of eduVote very positively, felt stronger engaged and better motivated to deal with the respective topics and would prefer their integration into additional courses as well. In particular we identified that students who feel uncomfortable with answering questions in front of others profit from the use of an audience response system during teaching.
CONCLUSIONS


Audience response systems motivate and activate students and increase their engagement during classes. However, their impact on long-term persistence and summative assessments may be limited. Audience response systems, however, specifically allow activating students which cannot be reached by the traditional way of asking questions without such an anonymous tool.",2020,In our controlled crossover study we could not confirm an impact of the audience response system eduVote on long-term persistence i.e. the students' performance in the summative assessment.,"['students who feel uncomfortable with answering questions in front of others profit from the use of an audience response system during teaching', 'One hundred fifty-four students in nine groups were taught the same content']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",[],[],154.0,0.0185939,In our controlled crossover study we could not confirm an impact of the audience response system eduVote on long-term persistence i.e. the students' performance in the summative assessment.,"[{'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany. Thorsten.Schmidt@med.uni-tuebingen.de.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Gazou', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Rieß', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Rieß', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Grundmann-Hauser', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Falb', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Malou', 'Initials': 'M', 'LastName': 'Schadeck', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Heinrich', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Mahkameh', 'Initials': 'M', 'LastName': 'Abeditashi', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Ulrike A', 'Initials': 'UA', 'LastName': 'Mau-Holzmann', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Kai P', 'Initials': 'KP', 'LastName': 'Schnabel', 'Affiliation': 'Institute for Medical Education, Department for Education and Media, University of Bern, Bern, Switzerland.'}]",BMC medical education,['10.1186/s12909-020-02130-4']
2389,32660512,Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease.,"BACKGROUND


This study aimed to evaluate the effectiveness of a customized interactive video game-based (IVGB) training on balance in older adults with mild-to-moderate Parkinson's disease (PD).
METHODS


In this 12-week crossover trial, PD patients ≥65 years of age were randomly divided into Group A (a 6-week intervention phase followed by a 6-week control phase) and Group B (a 6-week control phase followed by a 6-week intervention phase). Participants received IVGB exercise training during the intervention phase and no exercise during the control phase. Functional outcomes were measured using behavioral evaluation scales and questionnaires at baseline, week 6 and week 12.
RESULTS


Twenty-four PD patients were included in this study, and were evenly divided into two groups. After Bonferroni adjustment, the changes in Modified Falls Efficacy Scale (MFES) and two subscales of Multi-Directional Reach Test were significantly different between two groups in the first 6-week period. In addition, the changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length were significantly different between two groups in the second 6-week period. Compared to controls, 6-week IVGB exercise intervention significantly improved different but overlapping functional outcomes in two groups of PD patients.
CONCLUSIONS


The customized IVGB exercise training improves balance, postural stability and confidence in preventing falls in older adults with mild-to-moderate PD. However, this IVGB exercise doesn't have a significant impact on quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov. NCT03689764 . Registered 27 September 2018, retrospectively registered.",2020,"In addition, the changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length were significantly different between two groups in the second 6-week period.","['older adults with mild-to-moderate PD', 'PD patients ≥65\u2009years of age', ""older adults with mild-to-moderate Parkinson's disease"", ""older adults with mild-to-moderate Parkinson's disease (PD"", 'Twenty-four PD patients']","['customized IVGB exercise training', 'IVGB exercise training', 'IVGB exercise', 'interactive video-game-based exercise', 'IVGB exercise intervention', 'customized interactive video game-based (IVGB) training']","['quality of life', 'behavioral evaluation scales and questionnaires', 'changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length', 'balance, postural stability and confidence', 'Modified Falls Efficacy Scale (MFES) and two subscales of Multi-Directional Reach Test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.015981,"In addition, the changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length were significantly different between two groups in the second 6-week period.","[{'ForeName': 'Rey-Yue', 'Initials': 'RY', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Ching', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Peng', 'Affiliation': 'Taipei Neuroscience Institute, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Nung', 'Initials': 'YN', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Tai', 'Initials': 'YT', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, No. 252, Wu-Hsing St., Taipei City, 110, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. chlai@tmu.edu.tw.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00725-y']
2390,32660517,"Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study).","BACKGROUND


Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation.
METHODS


We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0-24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms.
RESULTS


None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was - 4.0 (95%CI, - 6.9 to - 1.2), compared to - 0.5 (95%CI, - 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis).
CONCLUSIONS


We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02323412 , First registered 23 December 2014.",2020,We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes.,"['One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n\u2009=\u2009118) or type II (n\u2009=\u200962', 'patients with chronic low back pain and Modic changes - secondary analyses', 'patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation', 'patients with chronic low back pain and Modic changes', 'patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes']","['amoxicillin', 'antibiotic treatment', 'placebo']","['RMDQ points', 'mean RMDQ score', 'Roland-Morris Disability Questionnaire (RMDQ) score', 'Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",180.0,0.460685,We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes.,"[{'ForeName': 'Lars Christian Haugli', 'Initials': 'LCH', 'LastName': 'Bråten', 'Affiliation': 'FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway. l.c.h.braten@studmed.uio.no.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Are Hugo', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Postbox 4950 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Helllum', 'Affiliation': 'Department of Orthopaedic surgery, Oslo University Hospital, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Anne Julsrud', 'Initials': 'AJ', 'LastName': 'Haugen', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Froholdt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Drammen Hospital, Vestre Viken Hospital Trust Drammen, Postboks 800, 3004, Drammen, Norway.'}, {'ForeName': 'Mads Peder', 'Initials': 'MP', 'LastName': 'Rolfsen', 'Affiliation': 'Faculty of Medicine, University of Oslo, PO BOX 1078 Blindern, 0316, Oslo, Norway.'}, {'ForeName': 'Øystein Petter', 'Initials': 'ØP', 'LastName': 'Nygaard', 'Affiliation': 'Department of Neurosurgery, St. Olavs University Hospital, Postbox 3250 Torgarden, NO-7006, Trondheim, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Lutro', 'Affiliation': 'Stavanger University Hospital, Helse Stavanger HF, Postboks 8100, 4068, Stavanger, Norway.'}, {'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Audny', 'Initials': 'A', 'LastName': 'Anke', 'Affiliation': 'Department of Rehabilitation, University Hospital of North Norway, Postboks 100, 9038, Tromsø, Norway.'}, {'ForeName': 'Elina Iordanova', 'Initials': 'EI', 'LastName': 'Schistad', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ulleval, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Jan Sture', 'Initials': 'JS', 'LastName': 'Skouen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, Bergen, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Faculty of Medicine, University of Oslo, PO BOX 1078 Blindern, 0316, Oslo, Norway.'}, {'ForeName': 'John-Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03422-y']
2391,32660521,"Effect of bowel preparation volume in inpatient colonoscopy. Results of a prospective, randomized, comparative pilot study.","BACKGROUND


Inpatient status has been shown to be a predictor of poor bowel preparation for colonoscopy; however, the optimal bowel preparation regimen for hospitalized patients is unknown. Our aim was to compare the efficacy of bowel preparation volume size in hospitalized patients undergoing inpatient colonoscopy.
METHODS


This prospective, single blinded (endoscopist), randomized controlled trial was conducted as a pilot study at a tertiary referral medical center. Hospitalized patients undergoing inpatient colonoscopy were assigned randomly to receive a high, medium, or low-volume preparation. Data collection included colon preparation quality, based on the Boston Bowel Preparation Scale, and a questionnaire given to all subjects evaluating the ability to completely finish bowel preparation and adverse effects (unpleasant taste, nausea, and vomiting).
RESULTS


Twenty-five colonoscopies were performed in 25 subjects. Patients who received low-volume preparation averaged a higher mean total BBPS (7.4, SD 1.62), in comparison to patients who received high-volume (7.0, SD 1.41) and medium-volume prep (6.9, SD 1.55), P = 0.77. When evaluating taste a higher score meant worse taste. The low-volume group scored unpleasant taste as 0.6 (0.74), while the high-volume group gave unpleasant taste a score of 2.2 (0.97) and the medium-volume group gave a score of 2.1 (1.36), P < 0.01.
CONCLUSION


In this pilot study we found that low-volume colon preparation may be preferred in the inpatient setting due its better rate of tolerability and comparable bowel cleanliness when compared to larger volume preparation, although we cannot overreach any definitive conclusion. Further more robust studies are required to confirm these findings.
TRIAL REGISTRATION


The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies.
TRIAL REGISTRATION


NCT01978509 (terminated). Retrospectively registered on November 07, 2013.",2020,"Patients who received low-volume preparation averaged a higher mean total BBPS (7.4, SD 1.62), in comparison to patients who received high-volume (7.0, SD 1.41) and medium-volume prep (6.9, SD 1.55), P = 0.77.","['Hospitalized patients undergoing inpatient colonoscopy', 'Hospitalized Patients Colonoscopies', 'hospitalized patients undergoing inpatient colonoscopy', 'inpatient colonoscopy', 'Twenty-five colonoscopies were performed in 25 subjects', 'pilot study at a tertiary referral medical center']",[],"['mean total BBPS', 'unpleasant taste', 'adverse effects (unpleasant taste, nausea, and vomiting']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",25.0,0.0807768,"Patients who received low-volume preparation averaged a higher mean total BBPS (7.4, SD 1.62), in comparison to patients who received high-volume (7.0, SD 1.41) and medium-volume prep (6.9, SD 1.55), P = 0.77.","[{'ForeName': 'Patricia V', 'Initials': 'PV', 'LastName': 'Hernandez', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Horsley-Silva', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Snyder', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Baffy', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Atia', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Koepke', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Buras', 'Affiliation': 'Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic Arizona, Scottsdale, USA.'}, {'ForeName': 'Elisabeth S', 'Initials': 'ES', 'LastName': 'Lim', 'Affiliation': 'Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic Arizona, Scottsdale, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ruff', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Umar', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.'}, {'ForeName': 'Francisco C', 'Initials': 'FC', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA. Ramirez.Francisco@mayo.edu.'}]",BMC gastroenterology,['10.1186/s12876-020-01373-1']
2392,32660526,The effect of a pre- and post-operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial.,"BACKGROUND


Advances in peri-operative oncological treatment, surgery and peri-operative care have improved survival for patients with oesophagogastric cancers. Neoadjuvant cancer treatment (NCT) reduces physical fitness, which may reduce both compliance and tolerance of NCT as well as compromising post-operative outcomes. This is particularly detrimental in a patient group where malnutrition is common and surgery is demanding. The aim of this trial is to assess the effect on physical fitness and clinical outcomes of a comprehensive exercise training programme in patients undergoing NCT and surgical resection for oesophagogastric malignancies.
METHODS


The PERIOP-OG trial is a pragmatic, multi-centre, randomised controlled trial comparing a peri-operative exercise programme with standard care in patients with oesophagogastric cancers treated with NCT and surgery. The intervention group undergo a formal exercise training programme and the usual care group receive standard clinical care (no formal exercise advice). The training programme is initiated at cancer diagnosis, continued during NCT, between NCT and surgery, and resumes after surgery. All participants undergo assessments at baseline, post-NCT, pre-surgery and at 4 and 10 weeks after surgery. The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in the 6-min walk test assessed at the pre-surgery timepoint. Secondary endpoints include measures of physical health (upper and lower body strength tests), body mass index, frailty, activity behaviour, psychological and health-related quality of life outcomes. Exploratory endpoints include a health economics analysis, assessment of clinical health by post-operative morbidity scores, hospital length of stay, nutritional status, immune and inflammatory markers, and response to NCT. Rates of NCT toxicity, tolerance and compliance will also be assessed.
DISCUSSION


The PERIOP-OG trial will determine whether, when compared to usual care, exercise training initiated at diagnosis and continued during NCT, between NCT and surgery and then during recovery, can maintain or improve cardiorespiratory fitness and other physical, psychological and clinical health outcomes. This trial will inform both the prescription of exercise regimes as well as the design of a larger prehabilitation and rehabilitation trial to investigate whether exercise in combination with nutritional and psychological interventions elicit greater benefits.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03807518 . Registered on 1 January 2019.",2020,The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in the 6-min walk test assessed at the pre-surgery timepoint.,"['patients with oesophagogastric cancers treated with NCT and surgery', 'patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial', 'patients with oesophagogastric cancers', 'patients undergoing NCT and surgical resection for oesophagogastric malignancies']","['Neoadjuvant cancer treatment (NCT', 'peri-operative exercise\xa0programme with standard care', 'comprehensive exercise training programme', 'formal exercise training programme and the usual care group receive standard clinical care (no formal exercise advice', 'pre- and post-operative exercise programme versus standard care']","['physical health (upper and lower body strength tests), body mass index,\xa0frailty, activity behaviour, psychological and health-related quality of life outcomes', 'health economics analysis, assessment of clinical health by post-operative morbidity scores, hospital length of stay, nutritional status, immune and inflammatory markers, and response to NCT', 'physical fitness', 'cardiorespiratory fitness measured by demonstration of a 15% difference in the 6-min walk test assessed at the pre-surgery timepoint', 'Rates of NCT toxicity, tolerance and compliance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0418878', 'cui_str': 'Recommendation to exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.11214,The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in the 6-min walk test assessed at the pre-surgery timepoint.,"[{'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Tully', 'Affiliation': 'Department of Upper GI Surgery, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Loughney', 'Affiliation': 'The Royal College of Surgeons in Ireland, St. Stephens Green, Dublin, Ireland.'}, {'ForeName': 'Jarlath', 'Initials': 'J', 'LastName': 'Bolger', 'Affiliation': 'Department of Upper GI Surgery, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Sorensen', 'Affiliation': 'The Royal College of Surgeons in Ireland, St. Stephens Green, Dublin, Ireland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'McAnena', 'Affiliation': 'Department of Upper GI Surgery, University Hospital, Galway, Ireland.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Collins', 'Affiliation': 'Department of Upper GI Surgery, University Hospital, Galway, Ireland.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Carroll', 'Affiliation': 'Department of Upper GI Surgery, University Hospital, Galway, Ireland.'}, {'ForeName': 'Mayilone', 'Initials': 'M', 'LastName': 'Arumugasamy', 'Affiliation': 'Department of Upper GI Surgery, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Tomas J', 'Initials': 'TJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Upper GI Surgery, Mercy University Hospital, Cork, Ireland.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Robb', 'Affiliation': 'Department of Upper GI Surgery, Beaumont Hospital, Dublin, Ireland. wrobb@rcsi.ie.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04311-4']
2393,32660530,"Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial.","BACKGROUND


The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone.
METHODS


The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients' survival rate at 12 months after surgery.
DISCUSSION


The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04037267 . Registered on 26 July 2019.",2020,The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH.,"['patients with moderate to severe intraventricular hemorrhage', 'patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone', 'Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China', 'patients with moderate to severe IVH']","['Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage', 'endoscopic IVH evacuation surgery', 'endoscopic IVH evacuation surgery or EVD', 'neuroendoscopy']","[""patients' survival rate""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0948930', 'cui_str': 'Ventricular drainage'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1261965', 'cui_str': 'Evacuation of hematoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0948930', 'cui_str': 'Ventricular drainage'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0844266', 'cui_str': 'Neuroendoscopy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",956.0,0.15382,The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH.,"[{'ForeName': 'Junhao', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Jinling Hospital, School of Medicine, Nanjing Medical University, 104 Hanzhong Road, Nanjing, 210002, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, China.'}, {'ForeName': 'Zixiang', 'Initials': 'Z', 'LastName': 'Cong', 'Affiliation': 'Department of Neurosurgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Jinling Hospital, School of Medicine, Nanjing Medical University, 104 Hanzhong Road, Nanjing, 210002, China.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, 210009, China.'}, {'ForeName': 'Chiyuan', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Jinling Hospital, School of Medicine, Nanjing Medical University, 104 Hanzhong Road, Nanjing, 210002, China. machiyuan_nju@126.com.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Statistics, Jinling Hospital, Nanjing Medical University, Nanjing, 210002, China. liu_yuxiu@163.com.'}]",Trials,['10.1186/s13063-020-04560-3']
2394,32660564,Oil supplementation with a special combination of n-3 and n-6 long-chain polyunsaturated fatty acids does not protect for exercise induced asthma: a double-blind placebo-controlled trial.,"BACKGROUND


Many patients suffering from exercise-induced asthma (EIA) have normal lung function at rest and show symptoms and a decline in FEV 1  when they do sports or during exercise-challenge. It has been described that long-chain polyunsaturated fatty acids (LCPUFA) could exert a protective effect on EIA.
METHODS


In this study the protective effect of supplementation with a special combination of n-3 and n-6 LCPUFA (sc-LCPUFA) (total 1.19 g/ day) were investigated in an EIA cold air provocation model.
PRIMARY OUTCOME MEASURE


Decrease in FEV 1  after exercise challenge and secondary outcome measure: anti-inflammatory effects monitored by exhaled NO (eNO) before and after sc-LCPUFA supplementation versus placebo.
RESULTS


Ninety-nine patients with exercise-induced symptoms aged 10 to 45 were screened by a standardized exercise challenge in a cold air chamber at 4 °C. Seventy-three patients fulfilled the inclusion criteria of a FEV 1  decrease > 15% and were treated double-blind placebo-controlled for 4 weeks either with sc-LCPUFA or placebo. Thirty-two patients in each group completed the study. Mean FEV 1  decrease after cold air exercise challenge and eNO were unchanged after 4 weeks sc-LCPUFA supplementation.
CONCLUSION


Supplementation with sc-LCPUFA at a dose of 1.19 g/d did not have any broncho-protective and anti-inflammatory effects on EIA.
TRIAL REGISTRATION


Clinical trial registration number: NCT02410096. Registered 7 February 2015 at Clinicaltrial.gov.",2020,"Mean FEV 1  decrease after cold air exercise challenge and eNO were unchanged after 4 weeks sc-LCPUFA supplementation.
CONCLUSION


Supplementation with sc-LCPUFA at a dose of 1.19 g/d did not have any broncho-protective and anti-inflammatory effects on EIA.
","['patients suffering from exercise-induced asthma (EIA', 'Seventy-three patients fulfilled the inclusion criteria of a FEV 1  decrease >\u200915% and were treated double-blind', 'Ninety-nine patients with exercise-induced symptoms aged 10 to 45 were screened by a standardized exercise challenge in a cold air chamber at 4\u2009°C']","['n-3 and n-6 LCPUFA (sc-LCPUFA', 'Supplementation with sc-LCPUFA', 'sc-LCPUFA or placebo', 'Oil supplementation', 'n-3 and n-6 long-chain polyunsaturated fatty acids', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004099', 'cui_str': 'Exercise-induced asthma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0860907', 'cui_str': 'FEV 1 low'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1293901', 'cui_str': 'Exercise challenge'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]",[],99.0,0.593836,"Mean FEV 1  decrease after cold air exercise challenge and eNO were unchanged after 4 weeks sc-LCPUFA supplementation.
CONCLUSION


Supplementation with sc-LCPUFA at a dose of 1.19 g/d did not have any broncho-protective and anti-inflammatory effects on EIA.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dreßler', 'Affiliation': 'Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic fibrosis, Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fussbroich', 'Affiliation': 'Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic fibrosis, Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Böhler', 'Affiliation': 'Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic fibrosis, Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Herrmann', 'Affiliation': 'Institute of Biostatistics and Mathematical Modelling, Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Benker', 'Affiliation': 'Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic fibrosis, Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tytyk', 'Affiliation': 'Department of Food Technology, University of Applied Science, Fulda, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schulze', 'Affiliation': 'Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic fibrosis, Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schubert', 'Affiliation': 'Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic fibrosis, Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Beermann', 'Affiliation': 'Department of Food Technology, University of Applied Science, Fulda, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zielen', 'Affiliation': 'Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic fibrosis, Goethe-University, Frankfurt/Main, Germany. Stefan.Zielen@kgu.de.'}]",Lipids in health and disease,['10.1186/s12944-020-01343-2']
2395,32660566,The influence of amaranth (Amaranthus hypochondriacus) dietary nitrates on the aerobic capacity of physically active young persons.,"BACKGROUND


Recent evidence indicates that elevating plasma nitrites through dietary nitrates (NO 3 - ) supplementation is associated with enhanced muscle efficiency, fatigue resistance and performance. Beetroot (in various forms) is the dominant source of dietary NO 3 -  primarily due to its vast availability and the simple form of preparation suitable for final consumption. After a few years of research and experimentation, our scientific team identified alternative source rich with dietary NO 3 -  as possible nitric oxide precursor, amaranth (Amaranthus hypochondriacus) with a standardized concentration 9-11% of NO 3 - . This study aimed to evaluate the effect of single-dose (±400 mg of dietary NO 3 - ) and long-term (6 days) supplementation of amaranth concentrate derived dietary NO 3 -  on aerobic capacity in physically active young people.
METHODS


We conducted a randomized, double-blind, placebo-controlled human study. Thirteen healthy and physically active young male participants were randomized into experimental and placebo groups. The aerobic capacity was tested during increasing cycling exercise (ICE) with pulmonary gas exchange recording and analysis.
RESULTS


The peak power of the ICE, the maximum oxygen consumption and the first ventilatory threshold were significantly increased after long-term consumption of dietary amaranth (from 4.44 ± 0.50 to 4.55 ± 0.43 W/kg; from 37.7 ± 2.7 to 41.2 ± 5.4 mL/kg/min and from 178.6 ± 30.3 to 188.6 ± 35.2 W, p < 0.05; respectively) in experimental group.
CONCLUSIONS


Long-term (6 days) use of dietary NO 3 -  from amaranth may improve the aerobic capacity during ICE in young physically active male persons. It can be recommended as the nutritional supplement during last week of preparation for competition in endurance events.",2020,"The peak power of the ICE, the maximum oxygen consumption and the first ventilatory threshold were significantly increased after long-term consumption of dietary amaranth (from 4.44 ± 0.50 to 4.55 ± 0.43 W/kg; from 37.7 ± 2.7 to 41.2 ± 5.4 mL/kg/min and from 178.6 ± 30.3 to 188.6 ± 35.2 W, p < 0.05; respectively) in experimental group.
","['young physically active male persons', 'physically active young persons', 'physically active young people', 'Thirteen healthy and physically active young male participants']","['amaranth (Amaranthus hypochondriacus) dietary nitrates', 'dietary', 'single-dose (±400\u2009mg of dietary NO 3 - ) and long-term (6\u2009days) supplementation of amaranth concentrate derived dietary', 'cycling exercise (ICE) with pulmonary gas exchange recording and analysis', 'placebo']","['peak power of the ICE, the maximum oxygen consumption and the first ventilatory threshold', 'aerobic capacity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C0330370', 'cui_str': 'Amaranthus'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0034071', 'cui_str': 'Exchange, Pulmonary Gas'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",13.0,0.11493,"The peak power of the ICE, the maximum oxygen consumption and the first ventilatory threshold were significantly increased after long-term consumption of dietary amaranth (from 4.44 ± 0.50 to 4.55 ± 0.43 W/kg; from 37.7 ± 2.7 to 41.2 ± 5.4 mL/kg/min and from 178.6 ± 30.3 to 188.6 ± 35.2 W, p < 0.05; respectively) in experimental group.
","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Liubertas', 'Affiliation': 'Department of Coaching Science, Lithuanian Sports University, 44221, Kaunas, Lithuania. tomas.liubertas@stud.lsu.lt.'}, {'ForeName': 'Ramutis', 'Initials': 'R', 'LastName': 'Kairaitis', 'Affiliation': 'Department of Coaching Science, Lithuanian Sports University, 44221, Kaunas, Lithuania.'}, {'ForeName': 'Loreta', 'Initials': 'L', 'LastName': 'Stasiule', 'Affiliation': 'Department of Applied Biology and Rehabilitation, Lithuanian Sports University, 44221, Kaunas, Lithuania.'}, {'ForeName': 'Sandrija', 'Initials': 'S', 'LastName': 'Capkauskiene', 'Affiliation': 'Department of Applied Biology and Rehabilitation, Lithuanian Sports University, 44221, Kaunas, Lithuania.'}, {'ForeName': 'Arvydas', 'Initials': 'A', 'LastName': 'Stasiulis', 'Affiliation': 'Department of Applied Biology and Rehabilitation, Lithuanian Sports University, 44221, Kaunas, Lithuania.'}, {'ForeName': 'Pranas', 'Initials': 'P', 'LastName': 'Viskelis', 'Affiliation': 'Institute of Horticulture, Lithuanian Research Centre for Agriculture and Forestry, 54333, Babtai, Lithuania.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Viškelis', 'Affiliation': 'Institute of Horticulture, Lithuanian Research Centre for Agriculture and Forestry, 54333, Babtai, Lithuania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Urbonaviciene', 'Affiliation': 'Institute of Horticulture, Lithuanian Research Centre for Agriculture and Forestry, 54333, Babtai, Lithuania.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00366-5']
2396,32652863,Impact of interval walking training managed through smart mobile devices on albuminuria and leptin/adiponectin ratio in patients with type 2 diabetes.,"BACKGROUND


Interval walking training has demonstrated more pronounced positive effects on physical fitness and metabolism in type 2 diabetes (T2D), compared to continuous walking. One of the pathogenic mechanisms of T2D is associated with derangements in leptin/adiponectin axis, which might predispose affected individuals to vascular inflammation and albuminuria. The aim of this study was to investigate the effects of interval walking training delivered through smart mobile devices upon albuminuria and leptin/adiponectin ratio in patients with T2D.
METHODS


Patients with T2D aged 35-75 were randomized into control (n = 26) and interval training (IT, n = 14) groups. Patients in IT group had to perform three 60-min interval walking sessions (3 min intervals of slow and fast walking with the intensity of 40% and 70% of the peak energy expenditure) per week delivered by smartphone application for four months. The adherence to training was monitored remotely. Outcome measures were albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control. Leptin and adiponectin concentration was measured in serum samples by Luminex technology.
RESULTS


In the IT group compared to control group, we observed a statistically significant decrease in albuminuria (p = .002) and leptin/adiponectin ratio (p = .01), as well as a decrease in HbA1c close to statistical significance (p = .09). In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
CONCLUSION


Interval walking training is beneficial for vascular health in T2D via impact on albuminuria and leptin/adiponectin ratio.",2020,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","['patients with T2D.\nMETHODS\n\n\nPatients with T2D aged 35-75', 'patients with type 2 diabetes']","['interval walking training managed through smart mobile devices', 'smart mobile devices', 'interval walking training', 'Interval walking training']","['hip circumference', 'albuminuria and leptin/adiponectin ratio', 'Leptin and adiponectin concentration', 'albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control', 'leptin/adiponectin ratio', 'changes in leptin/adiponectin ratio', 'albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",75.0,0.0424762,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","[{'ForeName': 'Jelizaveta', 'Initials': 'J', 'LastName': 'Sokolovska', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ostrovska', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Pahirko', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Gunita', 'Initials': 'G', 'LastName': 'Varblane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Krilatiha', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Austris', 'Initials': 'A', 'LastName': 'Cirulnieks', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Folkmane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Valeinis', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Aija', 'Initials': 'A', 'LastName': 'Klavina', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Selavo', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}]",Physiological reports,['10.14814/phy2.14506']
2397,32656738,Dynamic Eye Tracking as a Predictor and Outcome Measure of Social Skills Intervention in Adolescents and Adults with Autism Spectrum Disorder.,"To evaluate an eye tracking task as a predictor and outcome measure of treatment response for autism spectrum disorder (ASD) social skills interventions, adolescents and young adults with ASD completed the eye tracking task before, immediately after, and two months after completing Social Cognition and Interaction Training for Autism (SCIT-A). The study compared SCIT-A participants (n = 20) to participants with ASD who received treatment as usual (TAU; n = 21). Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.",2020,"Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.","['Adolescents and Adults with Autism Spectrum Disorder', 'autism spectrum disorder (ASD) social skills interventions, adolescents and young adults with ASD']",['Social Skills Intervention'],"['visual attention to faces and background objects and decreased attention to hands playing with toys', 'social functioning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0620067,"Overall, increased visual attention to faces and background objects and decreased attention to hands playing with toys at baseline were associated with improved social functioning immediately following intervention, suggesting this eye tracking task may reliably predict ASD social intervention outcomes.","[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Greene', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Parish-Morris', 'Affiliation': ""Center for Autism Research, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Kinard', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Maya G', 'Initials': 'MG', 'LastName': 'Mosner', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Turner-Brown', 'Affiliation': 'TEACCH Autism Program, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Penn', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Wiesen', 'Affiliation': 'The Odum Institute, The University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Pallathra', 'Affiliation': 'Center for Neurobiology and Behavior, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Brodkin', 'Affiliation': 'Center for Neurobiology and Behavior, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Schultz', 'Affiliation': ""Center for Autism Research, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Dichter', 'Affiliation': 'Carolina Institute for Developmental Disabilities, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA. dichter@med.unc.edu.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04594-1']
2398,32656739,Cost-utility of an eHealth application 'Oncokompas' that supports cancer survivors in self-management: results of a randomised controlled trial.,"PURPOSE


The eHealth self-management application 'Oncokompas' was developed to support cancer survivors in monitoring health-related quality of life (HRQOL) and symptoms, and obtaining personalized feedback and options for supportive care. The aim of this study was to assess the cost-utility of Oncokompas compared with care as usual (CAU) among cancer survivors.
METHODS


Survivors were randomly allocated to the intervention or control group. Direct (non-)medical, indirect non-medical costs, and HRQOL were measured at 3- and 6-month follow-up, using iMTA Medical Consumption and Productivity Costs and the EuroQol-5D questionnaires. Mean cumulative costs and quality-adjusted life-years (QALYs) were compared between both groups.
RESULTS


In total, 625 survivors were randomized into intervention (n = 320) or control group (n = 305). Base case analysis showed that incremental costs from a societal perspective were - €163 (95% CI, - 665 to 326), and incremental QALYs were 0.0017 (95% CI, - 0.0121 to 0.0155) in the intervention group compared with those in the control group. The probability that, compared with CAU, Oncokompas is more effective was 60%, less costly 73%, and both more effective and less costly 47%. Sensitivity analyses showed that incremental costs vary between - €40 and €69, and incremental QALYs vary between - 0.0023 and - 0.0057.
CONCLUSION


Oncokompas is likely to be equally effective on utilities, and not more expensive than CAU, and will therefore contribute to sustainable cancer survivorship care in a (cost-)effective manner.
IMPLICATIONS FOR CANCER SURVIVORS


Oncokompas seems to improve HRQOL and reduces the burden of several tumour-specific symptoms, while costs from a societal perspective are similar to CAU.",2020,"Mean cumulative costs and quality-adjusted life-years (QALYs) were compared between both groups.
","['Survivors', 'FOR CANCER SURVIVORS', 'cancer survivors in self-management', 'cancer survivors', '625 survivors']","[""eHealth application 'Oncokompas"", 'Oncokompas compared with care as usual (CAU']","['Mean cumulative costs and quality-adjusted life-years (QALYs', 'Direct (non-)medical, indirect non-medical costs, and HRQOL']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4517838', 'cui_str': '625'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",625.0,0.112051,"Mean cumulative costs and quality-adjusted life-years (QALYs) were compared between both groups.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'van der Hout', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Jansen', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'van Uden-Kraan', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Coupé', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Holtmaat', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Nieuwenhuijzen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Hardillo', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, ErasmusMC Cancer Centre, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'R J Baatenburg', 'Initials': 'RJB', 'LastName': 'de Jong', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, ErasmusMC Cancer Centre, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Tiren-Verbeet', 'Affiliation': 'Department of Hematology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'de Heer', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Schaar', 'Affiliation': 'Department of Internal Medicine, Gelre ziekenhuis, Apeldoorn, The Netherlands.'}, {'ForeName': 'R J E', 'Initials': 'RJE', 'LastName': 'Sedee', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Haaglanden MC, The Hague, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bosscha', 'Affiliation': 'Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, The Netherlands.'}, {'ForeName': 'M W M', 'Initials': 'MWM', 'LastName': 'van den Brekel', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Petersen', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Department of Hematology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Honings', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Takes', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Houtenbos', 'Affiliation': 'Department of Hematology, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'van den Broek', 'Affiliation': 'Department of Surgery, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Bree', 'Affiliation': 'Department of Head and Neck Surgical Oncology, Utrecht University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jansen', 'Affiliation': 'Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'S E J', 'Initials': 'SEJ', 'LastName': 'Eerenstein', 'Affiliation': 'Cancer Center Amsterdam (CCA), Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Leemans', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Cancer Center Amsterdam (CCA), Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'van de Poll-Franse', 'Affiliation': 'Department of Research, Netherlands Comprehensive Cancer Organisation, Eindhoven, The Netherlands.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. im.verdonck@amsterdamumc.nl.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00912-9']
2399,32656770,The effect of diagnostic labels on teachers' perceptions of behaviours of students with autism spectrum disorder.,"BACKGROUND


In Singapore, despite the availability of specialized services and resources in mainstream schools for students with special educational needs, parents can still be hesitant to disclose their child's diagnosis of autism spectrum disorder (ASD), for fear of stigma or negative attitudes from teachers and peers.
AIM


This study aims to understand how diagnostic labels affect teachers' perceptions of behaviours in students with ASD in mainstream primary schools, particularly behaviours which are difficult for educators to manage in the classroom setting. Based on research suggesting that a diagnostic label can provide an alternative explanation for atypical behaviours and reduce negative impressions, we hypothesize that teachers would perceive these behaviours of children with ASD less negatively as compared to children without any diagnostic labels.
SAMPLE


The sample consisted of 120 mainstream primary school teachers who reported a mean of 9.97 years (SD = 7.96) of teaching experience. Majority of participants (65%) indicated that they had direct experience of teaching students with ASD in mainstream schools (mean years = 3.58, SD = 4.77).
METHOD


Participants read a total of 20 vignettes depicting a range of behaviours typically observed in primary school-aged students with ASD. Participants were asked to rate the featured student's behaviour on a 5-point Likert scale (i.e., 1 = strongly negative, 2 = negative, 3 = neutral, 4 = positive, and 5 = strongly positive). The survey vignettes were presented in a randomized order, and participants were randomly assigned to either the experimental group (awareness of diagnostic label) or the control group (non-awareness of label).
RESULTS


Results indicated that the experimental group rated the behaviours less negatively than the control group. Qualitative feedback from participants also indicated that knowledge of the diagnostic label helped them to perceive the behaviours more positively.
CONCLUSION


Findings from this study have implications for parents regarding diagnosis disclosure and may serve as an encouragement to parents to consider disclosing their child's ASD diagnosis to the school.",2020,"RESULTS


Results indicated that the experimental group rated the behaviours less negatively than the control group.","['students with ASD in mainstream primary schools', 'Participants read a total of 20 vignettes depicting a range of behaviours typically observed in primary school-aged students with ASD', ""teachers' perceptions of behaviours of students with autism spectrum disorder"", '120 mainstream primary school teachers who reported a mean of 9.97\xa0years (SD\xa0=\xa07.96) of teaching experience']","['experimental group (awareness of diagnostic label) or the control group (non-awareness of label', 'diagnostic labels']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],120.0,0.0564459,"RESULTS


Results indicated that the experimental group rated the behaviours less negatively than the control group.","[{'ForeName': 'Yong-Hwee', 'Initials': 'YH', 'LastName': 'Nah', 'Affiliation': 'National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Julianne Wen-Li', 'Initials': 'JW', 'LastName': 'Tan', 'Affiliation': 'National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}]",The British journal of educational psychology,['10.1111/bjep.12368']
2400,32656799,"Optimising the value of immunomodulatory drugs during induction and maintenance in transplant ineligible patients with newly diagnosed multiple myeloma: results from Myeloma XI, a multicentre, open-label, randomised, Phase III trial.","Second-generation immunomodulatory agents, such as lenalidomide, have a more favourable side-effect profile than the first-generation thalidomide, but their optimum combination and duration for patients with newly diagnosed transplant-ineligible myeloma (ND-TNE-MM) has not been defined. The most appropriate delivery and dosing regimens of these therapies for patients at advanced age and frailty status is also unclear. The Myeloma XI study compared cyclophosphamide, thalidomide and dexamethasone (CTDa) to cyclophosphamide, lenalidomide and dexamethasone (CRDa) as induction therapy, followed by a maintenance randomisation between ongoing therapy with lenalidomide or observation for patients with ND-TNE-MM. CRDa deepened response but did not improve progression-free (PFS) or overall survival (OS) compared to CTDa. However, analysis by age group highlighted significant differences in tolerability in older, frailer patients that may have limited treatment delivery and impacted outcome. Deeper responses and PFS and OS benefits with CRDa over CTDs were seen in patients aged ≤70 years, with an increase in toxicity and discontinuation observed in older patients. Our results highlight the importance of considering age and frailty in the approach to therapy for patients with ND-TNE-MM, highlighting the need for prospective validation of frailty adapted therapy approaches, which may improve outcomes by tailoring treatment to the individual.",2020,CRDa deepened response but did not improve progression-free (PFS) or overall survival (OS) compared to CTDa.,"['transplant ineligible patients with newly diagnosed multiple myeloma', 'patients with newly diagnosed transplant-ineligible myeloma (ND-TNE-MM', 'patients at advanced age and frailty status', 'patients with ND-TNE-MM', 'patients aged ≤70\xa0years']","['cyclophosphamide, thalidomide and dexamethasone (CTDa) to cyclophosphamide, lenalidomide and dexamethasone (CRDa']","['progression-free (PFS) or overall survival (OS', 'tolerability', 'toxicity and discontinuation']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.0419444,CRDa deepened response but did not improve progression-free (PFS) or overall survival (OS) compared to CTDa.,"[{'ForeName': 'Graham H', 'Initials': 'GH', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Collett', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Waterhouse', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Western Sussex Hospitals NHS Foundation Trust, Chichester, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Russells Hall Hospital, Dudley, UK.'}, {'ForeName': 'Bhuvan', 'Initials': 'B', 'LastName': 'Kishore', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Williams', 'Affiliation': 'Centre for Clinical Haematology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Kamaraj', 'Initials': 'K', 'LastName': 'Karunanithi', 'Affiliation': 'University Hospital of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Jindriska', 'Initials': 'J', 'LastName': 'Lindsay', 'Affiliation': 'E1ast Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Russell', 'Affiliation': 'Centre for Clinical Haematology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NY Langone Health, New York, NY, USA.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NY Langone Health, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of haematology,['10.1111/bjh.16945']
2401,32657253,Methylation of cysteinyl leukotriene receptor 1 genes associates with lung function in asthmatics exposed to traffic-related air pollution.,"Air pollution is associated with early declines in lung function and increased levels of asthma-related cysteinyl leukotrienes (CysLT) but a biological pathway linking this rapid response has not been delineated. In this randomized controlled diesel exhaust (DE) challenge study of 16 adult asthmatics, increased exposure-attributable urinary leukotriene E4 (uLTE4, a biomarker of cysteinyl leukotriene production) was correlated (p = 0.04) with declines in forced expiratory volume in 1-second (FEV 1 ) within 6 hours of exposure. Exposure-attributable uLTE4 increases were correlated (p = 0.02) with increased CysLT receptor 1 (CysLTR1) methylation in peripheral blood mononuclear cells which, in turn, was marginally correlated (p = 0.06) with decreased CysLTR1 expression. Decreased CysLTR1 expression was, in turn, correlated (p = 0.0007) with FEV 1  declines. During the same time period, increased methylation of GPR17 (a negative regulator of CysLTR1) was observed after DE exposure (p = 0.02); this methylation increase was correlated (p = 0.001) with decreased CysLTR1 methylation which, in turn, was marginally correlated (p = 0.06) with increased CysLTR1 expression; increased CysLTR1 expression was correlated (p = 0.0007) with FEV 1  increases. Collectively, these data delineate a potential mechanistic pathway linking increased DE exposure-attributable CysLT levels to lung function declines through changes in CysLTR1-related methylation and gene expression.",2020,Air pollution is associated with early declines in lung function and increased levels of asthma-related cysteinyl leukotrienes (CysLT) but a biological pathway linking this rapid response has not been delineated.,['16 adult asthmatics'],[],"['CysLTR1 expression', 'CysLTR1 methylation', 'methylation of GPR17 (a negative regulator of CysLTR1', 'CysLT receptor 1 (CysLTR1) methylation in peripheral blood mononuclear cells', 'exposure-attributable urinary leukotriene E4 (uLTE4, a biomarker of cysteinyl leukotriene production', 'Decreased CysLTR1 expression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",[],"[{'cui': 'C0125642', 'cui_str': 'leukotriene D4 receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C1333731', 'cui_str': 'GPR17 protein, human'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0753791', 'cui_str': 'cysteinyl leukotriene receptor'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0675175', 'cui_str': 'cysteinyl-leukotriene'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",16.0,0.0173799,Air pollution is associated with early declines in lung function and increased levels of asthma-related cysteinyl leukotrienes (CysLT) but a biological pathway linking this rapid response has not been delineated.,"[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rabinovitch', 'Affiliation': ""Department of Pediatrics P: 303-398-1992, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'Meaghan J', 'Initials': 'MJ', 'LastName': 'Jones', 'Affiliation': ""Department of Medical Genetics P: 604-875-3194, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gladish', 'Affiliation': ""Department of Medical Genetics P: 604-875-3194, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Faino', 'Affiliation': 'Biostatistics Program P: 206-667-4995, Public Health Division, Fred Hutchinson Cancer Research Center , Seattle, WA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Strand', 'Affiliation': 'Department of Medicine P: 303-398-1862, National Jewish Health , Denver, CO, USA.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Morin', 'Affiliation': ""Department of Medical Genetics P: 604-875-3194, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'MacIsaac', 'Affiliation': ""Department of Medical Genetics P: 604-875-3194, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'David T S', 'Initials': 'DTS', 'LastName': 'Lin', 'Affiliation': ""Department of Medical Genetics P: 604-875-3194, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Reynolds', 'Affiliation': 'Department of Medicine P: 303-398-1862, National Jewish Health , Denver, CO, USA.'}, {'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Pathology and Laboratory Medicine P: 604-764-5827, University of British Columbia , Vancouver, BC, Canada.'}, {'ForeName': 'Erwin W', 'Initials': 'EW', 'LastName': 'Gelfand', 'Affiliation': ""Department of Pediatrics P: 303-398-1992, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kobor', 'Affiliation': ""Department of Medical Genetics P: 604-875-3194, Center for Molecular Medicine and Therapeutics, University of British Columbia/British Columbia Children's Hospital Research Institute , Vancouver, BC, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Department of Medicine, P: 604-875-4729, University of British Columbia , Vancouver, BC, Canada.'}]",Epigenetics,['10.1080/15592294.2020.1790802']
2402,32657437,Niacinamide mitigates SASP-related inflammation induced by environmental stressors in human epidermal keratinocytes and skin.,"OBJECTIVE


To evaluate whether niacinamide (Nam) can mitigate production of inflammatory and senescence-related biomarkers induced by environmental stressors.
METHODS


Human epidermal keratinocytes were exposed to UVB, urban dust, diesel exhaust, and cigarette smoke extract and treated with Nam or vehicle control. Full thickness 3-D skin organotypic models were exposed to a combination of UVB and PM 2.5  and treated with Nam or vehicle control. Quantitation of the SASP-related inflammatory mediators PGE 2  , IL-6, and IL-8 was performed on cultured media. UVB-exposed keratinocytes treated with and without Nam were immunostained for the senescence biomarker Lamin B1 (LmnB1). Transcriptomics profiling of cigarette smoke extract effects on keratinocytes was performed. A placebo controlled double blinded clinical was conducted on 40 female panelists that were pretreated on back sites for two weeks with 5% Nam or vehicle and then exposed to 1.5 minimal erythemal dose (MED) solar simulated radiation (SSR). Treated sites were compared to non-treated exposed sites for erythema and the skin surface IL-1αRA/IL-1α inflammatory biomarkers.
RESULTS


UVB induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes. Urban dust and diesel exhaust only stimulated synthesis of IL-8 whereas cigarette smoke extract only stimulated levels of PGE 2  . In all exposures, treatment with Nam significantly mitigated synthesis of the inflammatory mediators and restored levels of UVB-reduced LmnB1. In the 3D skin equivalent model, Nam reduced IL-8 levels stimulated by a combination of topical PM 2.5  and UV exposure. In a UV-challenge clinical, pretreatment with 5% Nam reduced erythema and skin surface IL-1αRA/IL-1α inflammatory biomarkers that were induced by SSR.
CONCLUSION


Since it is known that Nam has anti-inflammatory properties, we tested whether Nam can inhibit environmental stress induced inflammation and senescence-associated secretory phenotype (SASP) biomarkers. We show Nam can reduce PGE 2  , IL-6, and IL-8 levels induced by environmental stressors. Additionally, in vivo pretreatment with Nam can reduce UV-induced erythema and skin surface inflammatory biomarkers. These findings add to the body of evidence that Nam can mitigate the skin's inflammatory response elicited by environmental stressors. This supports Nam can potentially inhibit senescence and premature aging and thereby maintain skin's functionality and appearance.",2020,"RESULTS


UVB induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes.","['40 female panelists that were pretreated on back sites for two weeks with', 'Human epidermal keratinocytes were exposed to UVB, urban dust, diesel exhaust, and']","['niacinamide (Nam', 'cigarette smoke extract and treated with Nam or vehicle control', 'UVB and PM 2.5  and treated with Nam or vehicle control', '5% Nam or vehicle and then exposed to 1.5 minimal erythemal dose (MED) solar simulated radiation (SSR', 'placebo']","['synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels', 'PGE 2  , IL-6, and IL-8 levels', 'mitigated synthesis of the inflammatory mediators and restored levels of UVB-reduced LmnB1', 'IL-8 levels', 'erythema and skin surface IL-1αRA/IL-1α inflammatory biomarkers', 'UV-induced erythema and skin surface inflammatory biomarkers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",40.0,0.0491362,"RESULTS


UVB induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes.","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Bierman', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Laughlin', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Makio', 'Initials': 'M', 'LastName': 'Tamura', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Ben C', 'Initials': 'BC', 'LastName': 'Hulette', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Mack', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Sherrill', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Christina Y R', 'Initials': 'CYR', 'LastName': 'Tan', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, Singapore, Singapore.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Morenc', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, Singapore, Singapore.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bellanger', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, Singapore, Singapore.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Oblong', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}]",International journal of cosmetic science,['10.1111/ics.12651']
2403,32657457,Glycopyrrolate Improves Disability from Sialorrhea in Parkinson's Disease: A 12-Week Controlled Trial.,"OBJECTIVE


The objective of this study was to assess the 12-week efficacy and safety of oral glycopyrrolate for moderate-to-severe sialorrhea in Parkinson's disease (PD).
BACKGROUND


Chronic moderate-to-severe sialorrhea has a negative impact on quality of life in PD. There is no robust evidence for oral treatments for sialorrhea longer than 1 week.
METHODS


This was a 12-week, double-blinded, placebo-controlled, parallel phase II study in patients with PD and Movement Disorder Society-Unified Parkinson's Disease Rating Scale item 2.2 > 2. The intervention was glycopyrrolate up to 4.5 mg/d; the primary outcome was sialorrhea related-disability (Radboud Oral Motor Inventory for Parkinson's Disease-Saliva). We used an intention-to-treat analysis. A P < 0.05 was deemed significant.
RESULTS


We recruited 28 patients (age, 71.1 ± 6.9 years; PD duration, 11.4 ± 7.2 years; Radboud Oral Motor Inventory for Parkinson's Disease-Saliva, 22.4 ± 5.7). Glycopyrrolate was superior to placebo at 12 weeks in the Radboud Oral Motor Inventory for Parkinson's Disease-Saliva (between-group difference, 5.3; 95% confidence interval, 1.0-9.6). Dry mouth was the most common adverse event (glycopyrrolate, n = 6; placebo, n = 2).
CONCLUSIONS


The results support the efficacy of glycopyrrolate to treat sialorrhea-related disability up to 12 weeks and contribute to addressing unmet nonmotor care needs in PD. © 2020 International Parkinson and Movement Disorder Society.",2020,"Glycopyrrolate was superior to placebo at 12 weeks in the Radboud Oral Motor Inventory for Parkinson's Disease-Saliva (between-group difference, 5.3; 95% confidence interval, 1.0-9.6).","[""28 patients (age, 71.1\u2009±\u20096.9\u2009years; PD duration, 11.4\u2009±\u20097.2\u2009years; Radboud Oral Motor Inventory for Parkinson's Disease-Saliva, 22.4\u2009±\u20095.7"", ""Parkinson's Disease"", ""moderate-to-severe sialorrhea in Parkinson's disease (PD"", ""patients with PD and Movement Disorder Society-Unified Parkinson's Disease Rating Scale item 2.2\u2009>\u20092""]","['glycopyrrolate', 'oral glycopyrrolate', 'Glycopyrrolate', 'placebo']","['12-week efficacy and safety', ""sialorrhea related-disability (Radboud Oral Motor Inventory for Parkinson's Disease-Saliva""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037036', 'cui_str': 'Excessive salivation'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037036', 'cui_str': 'Excessive salivation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",,0.205804,"Glycopyrrolate was superior to placebo at 12 weeks in the Radboud Oral Motor Inventory for Parkinson's Disease-Saliva (between-group difference, 5.3; 95% confidence interval, 1.0-9.6).","[{'ForeName': 'Tiago A', 'Initials': 'TA', 'LastName': 'Mestre', 'Affiliation': 'University of Ottawa Brain and Mind Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Freitas', 'Affiliation': 'Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Basndwah', 'Affiliation': 'University of Ottawa Brain and Mind Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Marta Ruiz', 'Initials': 'MR', 'LastName': 'Lopez', 'Affiliation': 'Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Lais Machado', 'Initials': 'LM', 'LastName': 'de Oliveira', 'Affiliation': 'Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Duha Mohammed', 'Initials': 'DM', 'LastName': 'Al-Shorafat', 'Affiliation': 'Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Tinghua', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Ottawa Methods Center, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lui', 'Affiliation': 'Department of Pharmacy, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grimes', 'Affiliation': 'University of Ottawa Brain and Mind Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Fox', 'Affiliation': 'Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28196']
2404,32657494,Reducing loneliness among people with substance use disorders: Feasibility of 'Groups for Belonging'.,"INTRODUCTION AND AIMS


Although loneliness is common among people with substance use disorders, few interventions to reduce loneliness have been developed for this population. This study aimed to determine the feasibility of delivering a six-session group-based intervention, 'Groups for Belonging', that builds social group connectedness.
DESIGN AND METHODS


Participants were 41 individuals accessing residential substance use treatment services. The primary aims of the present study were to determine indicators of feasibility of Groups for Belonging; namely, demand (recruitment, attendance and retention) for and acceptability (program adherence and participant satisfaction) of the Groups for Belonging program in residential substance use treatment settings.
RESULTS


Over half of the people attending the services were interested in participating in Groups for Belonging. Of 41 participants who commenced the program, 20 participants completed the program per protocol. In terms of acceptability, the average number of sessions attended was 3.7 (SD = 1.76, range 1-6). Program adherence was 99.3% and overall satisfaction with the program was high, with 95% of participants reporting they enjoyed Groups for Belonging.
DISCUSSION AND CONCLUSIONS


The Groups for Belonging program may be feasible for delivery in residential substance use treatment services. Findings from this study suggest that an adequately powered replication study is warranted.",2020,"Program adherence was 99.3% and overall satisfaction with the program was high, with 95% of participants reporting they enjoyed Groups for Belonging.
","['Participants were 41 individuals accessing residential substance use treatment services', '41 participants who commenced the program, 20 participants completed the program per protocol', 'people with substance use disorders']",[],"['overall satisfaction', 'Program adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0750536,"Program adherence was 99.3% and overall satisfaction with the program was high, with 95% of participants reporting they enjoyed Groups for Belonging.
","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Ingram', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Haslam', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Owen J', 'Initials': 'OJ', 'LastName': ""O'Neil"", 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Genevieve A', 'Initials': 'GA', 'LastName': 'Dingle', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}]",Drug and alcohol review,['10.1111/dar.13121']
2405,32657512,Study of pregabalin effect on postsurgical pain in breast cancer patients: A double-blind randomized clinical trial using placebo.,,2020,,['breast cancer patients'],"['pregabalin', 'placebo']",['postsurgical pain'],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.657892,,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mir', 'Affiliation': 'Department of General Surgery, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Niayesh', 'Initials': 'N', 'LastName': 'Mohebbi', 'Affiliation': 'Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Omranipour', 'Affiliation': 'Breast Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Lashkari', 'Affiliation': 'Radiation Oncology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Masoomzadeh', 'Affiliation': 'Department of General Surgery, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",The breast journal,['10.1111/tbj.13979']
2406,32657704,Predischarge transcutaneous bilirubin screening reduces readmission rate for hyperbilirubinaemia in diverse South African newborns: A randomised controlled trial.,"BACKGROUND


In South Africa (SA), healthy term newborns are usually discharged ˂72 hours after delivery. Discharged babies remain at risk for severe hyperbilirubinaemia if it is not identified early. Hyperbilirubinaemia is an important cause of readmission, and also leads to neonatal mortality and morbidity. Use of transcutaneous bilirubin (TcB) screening before hospital discharge has been controversial.
OBJECTIVES


To test the clinical benefits of TcB screening of healthy newborns before discharge for the outcomes of readmission for jaundice and severe hyperbilirubinaemia in a randomised controlled trial (RCT).
METHODS


This was a RCT. We compared predischarge TcB screening with visual assessment (alone) for jaundice in apparently healthy newborns at a public tertiary hospital in Cape Town, SA. Patients or study participants were not involved in the study design and implementation.
RESULTS


Of the 1 858 infants, 63% were black, 35% of mixed race and 1% white. There was a significant reduction in the rate of readmission for jaundice (risk ratio (RR) 0.25; 95% confidence interval (CI) 0.14 - 0.46; p&lt;0.0001) and in the incidence of severe hyperbilirubinaemia (RR 0.27; 95% CI 0.08 - 0.97; p=0.05) with the use of TcB screening compared with visual inspection.
CONCLUSIONS


Predischarge TcB screening is superior in identifying newborns at risk of severe hyperbilirubinaemia compared with visual inspection. We recommend that every newborn, regardless of skin pigmentation, should receive objective bilirubin screening before hospital discharge. Universal bilirubin screening in newborns could potentially reduce hyperbilirubinaemia-related morbidity and mortality.",2020,"There was a significant reduction in the rate of readmission for jaundice (risk ratio (RR) 0.25; 95% confidence interval (CI) 0.14 - 0.46; p&lt;0.0001) and in the incidence of severe hyperbilirubinaemia (RR 0.27; 95% CI 0.08 - 0.97; p=0.05) with the use of TcB screening compared with visual inspection.
","['Of the 1 858 infants, 63% were black, 35% of mixed race and 1% white', 'hyperbilirubinaemia in diverse South African newborns', 'apparently healthy newborns at a public tertiary hospital in Cape Town, SA', 'healthy newborns']","['TcB screening', 'transcutaneous bilirubin (TcB) screening', 'Predischarge transcutaneous bilirubin screening', 'predischarge TcB screening with visual assessment (alone']","['incidence of severe hyperbilirubinaemia', 'rate of readmission for jaundice']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}]",63.0,0.285629,"There was a significant reduction in the rate of readmission for jaundice (risk ratio (RR) 0.25; 95% confidence interval (CI) 0.14 - 0.46; p&lt;0.0001) and in the incidence of severe hyperbilirubinaemia (RR 0.27; 95% CI 0.08 - 0.97; p=0.05) with the use of TcB screening compared with visual inspection.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Okwundu', 'Affiliation': 'Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa. charlesokwundu@gmail.com.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Bhutani', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Esterhuizen', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wiysonge', 'Affiliation': ''}]",South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde,['10.7196/SAMJ.2020.v110i3.14186']
2407,32657740,Water-wise hand preparation - the true impact of our practice: A controlled before-and-after study.,"BACKGROUND


South Africa (SA) and other countries worldwide are experiencing extreme drought conditions. Since the start of the drought in SA, many ways of saving water have been proposed and innovative water-saving mechanisms have become part of the lives of communities. We investigated water use during surgical scrubbing procedures and possible interventions to reduce water consumption.
OBJECTIVES


To compare water use during surgical hand preparation before and after the implementation of specific water-saving interventions.
METHODS


This was a non-randomised controlled study, following a before-and-after design, of orthopaedic theatre personnel scrubbing for surgical cases at Tygerberg Hospital, Cape Town. A control (CON) group (n=32) was established to observe standard practice for baseline measurements including total amount of water used, wash time and water flow rate during surgical hand preparation. After this, three interventions were randomly assigned to a single theatre each, where the same variables were measured. Intervention AS entailed using an alcohol scrub (n=18), intervention SN (n=12) had a dedicated assistant to open and close taps during scrubbing, and intervention SW (n=12) made use of adjusted tap levers to allow the surgeon to open and close taps more easily. Analysis of variance was used to detect global differences between groups, and Tukey's post hoc test was performed to detect differences between groups.
RESULTS


Significant differences in water use (p&lt;0.001), wash time (p&lt;0.001) and water flow rate (p&lt;0.001) were observed between the four groups. On average, the AS group used the least water per scrub (mean (standard deviation) 0.82 (1.43) L), which was significantly less than the CON (5.56 (1.79) L; p&lt;0.001) and SN (2.29 (0.37) L; p=0.002) groups. The amount of time spent per scrub was significantly less in the AS group than all the other groups (p&lt;0.05 for all comparisons), with no significant differences observed between the CON, SN and SW groups independently. The SW group had the lowest mean water flow rate (0.73 (0.22) L/min), which was significantly lower than the CON group (2.19 (0.84) L/min; p&lt;0.001). The flow rate of the SN group (1.36 (0.66) L/min) was also significantly lower than that of the CON group (p=0.005).
CONCLUSIONS


Water use during surgical hand preparation can easily be reduced by implementing easy and effective interventions. The practicality of interventions may differ between institutions, and their acceptance by surgical staff is important to ensure compliance. However, ensuring that alternative scrubbing options are available to surgical staff would equate to substantial savings over time.",2020,"RESULTS


Significant differences in water use (p&lt;0.001), wash time (p&lt;0.001) and water flow rate (p&lt;0.001) were observed between the four groups.","['surgical cases at Tygerberg Hospital, Cape Town']","['alcohol scrub (n=18), intervention SN (n=12) had a dedicated assistant to open and close taps during scrubbing, and intervention SW (n=12) made use of adjusted tap levers to allow the surgeon to open and close taps more easily', 'control (CON', 'CON', 'orthopaedic theatre personnel scrubbing']","['flow rate', 'water flow rate', 'lowest mean water flow rate', 'amount of time spent per scrub']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}]",,0.0399163,"RESULTS


Significant differences in water use (p&lt;0.001), wash time (p&lt;0.001) and water flow rate (p&lt;0.001) were observed between the four groups.","[{'ForeName': 'M S W', 'Initials': 'MSW', 'LastName': 'Potgieter', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa. Mswpot@yahoo.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Faisal', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ikram', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': ''}]",South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde,['10.7196/SAMJ.2020.v110i4.14044']
2408,32657759,"Fluid administration in Emergency Departments limited by Lung Ultrasound (FERLU) in Patients with Sepsis: Protocol for a Prospective Multi-Center Randomized, Controlled, Phase II trial.","BACKGROUND


Sepsis remains a major health challenge with high mortality. Adequate volume administration is fundamental for a successful outcome. But with varying degrees of systemic vasodilation, circulatory flow maldistribution and an increase in vascular permeability, the individual fluid need differs between patients. The current fluid resuscitation practice has been questioned. Fluid overload is associated with higher mortality in sepsis. A sign of fluid overload is extravascular lung water, seen as B-lines in lung ultrasound (US). B-lines correlate inversely with oxygenation (PaO2/FiO2). Thus B-lines seen by bedside ultrasound may have a role in guiding fluid therapy.
OBJECTIVE


To evaluate if fluid administration guided by lung US in patients with sepsis in the Emergency Departments (ED) will lead to better oxygenation and outcomes compared with standard therapy.
METHODS


A multi-center randomized, open-label, parallel group superiority, phase II trial will be performed (International Registered Report Identifier (IRRID): RR1-10.2196/15997). Recruitment of patients will occur at admission to the ED. A total sample size of 340 patients will be randomly allocated to the intervention or standard of care group (30ml/kg). The intervention group will receive ultrasound-guided intravenous fluid until 3 B-lines appear. The primary outcome will be oxygenation (PaO2/FiO2) at 48 hrs after starting IV fluid administration. Secondary outcomes will be patients' outcome parameters, including oxygenation, sepsis progress (SOFA), pulmonary edema course after 15ml/kg fluid and at 6, 12, 24, 48 hrs and 30-day mortality.
RESULTS


The trial will be executed in accordance with the Declaration of Helsinki. Institutional review board (IRB) approval, once the participating sites have been selected, will be sought. The protocol will be registered once participating sites have been decided and IRB approval granted. The trial duration is expected to be 1.5-2.5 years. The study is planned to be performed from 2021 to 2022, with enrolment starting in 2021. First results are expected in 2022. Informed written consent will be obtained before the patient's enrollment in the study. An interim analysis and data monitoring will ensure the patients' safety. The results will be published in a peer-reviewed journal and discussed at international conferences.
CONCLUSIONS


This is a protocol for an RCT that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B-Lines evaluation.
CLINICALTRIAL


",2020,"This is a protocol for an RCT that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B-Lines evaluation.
","['Patients with Sepsis', 'patients with sepsis via B-Lines evaluation', '340 patients', '2021 to 2022, with enrolment starting in 2021', 'patients with sepsis in the Emergency Departments (ED']",['Lung Ultrasound (FERLU'],"[""patients' outcome parameters, including oxygenation, sepsis progress (SOFA), pulmonary edema course after 15ml/kg fluid and at 6, 12, 24, 48 hrs and 30-day mortality"", 'oxygenation (PaO2/FiO2', 'vascular permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0162337', 'cui_str': 'Blood vessel permeability'}]",340.0,0.211776,"This is a protocol for an RCT that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B-Lines evaluation.
","[{'ForeName': 'Mouhand F H', 'Initials': 'MFH', 'LastName': 'Mohamed', 'Affiliation': 'Department of General Internal Medicine, Hamad Medical Corporation, Department of General Internal Medicine, Hamad Medical Corporation, Qatar. Al Rayyan road, P.O. BO 3050, Doha, QA.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Malewicz', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, US.'}, {'ForeName': 'Hanan Ibrahim', 'Initials': 'HI', 'LastName': 'Zehry', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, US.'}, {'ForeName': 'Dina A Monim', 'Initials': 'DAM', 'LastName': 'Hussain', 'Affiliation': 'Department of Obstetrics & Gynecology, Hamad medical corporation, Doha, QA.'}, {'ForeName': 'Judah Leão', 'Initials': 'JL', 'LastName': 'Barouh', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, US.'}, {'ForeName': 'Adriana V', 'Initials': 'AV', 'LastName': 'Cançado', 'Affiliation': 'Radiology Department, Santa Casa Belo Horizonte, Belo Horizonte, BR.'}, {'ForeName': 'Jeancarllo De Sousa', 'Initials': 'JS', 'LastName': 'Silva', 'Affiliation': 'Division of Oncological Surgery, State University of Amazonas, Manaus, BR.'}, {'ForeName': 'Salah', 'Initials': 'S', 'LastName': 'Suwileh', 'Affiliation': 'Department of General Internal Medicine, Hamad Medical Corporation, Department of General Internal Medicine, Hamad Medical Corporation, Qatar. Al Rayyan road, P.O. BO 3050, Doha, QA.'}, {'ForeName': 'Jose Retamal', 'Initials': 'JR', 'LastName': 'Carvajal', 'Affiliation': 'Faculty Of Emergency Medicine, Universidad Del Desarrollo-Clinica Alemana De Santiago, Santiago, CL.'}]",JMIR research protocols,['10.2196/15997']
2409,32657806,Comparative effects of neurally adjusted ventilatory assist and variable pressure support on lung and diaphragmatic function in a model of acute respiratory distress syndrome: A randomised animal study.,"BACKGROUND


Variable assisted mechanical ventilation has been shown to improve lung function and reduce lung injury. However, differences between extrinsic and intrinsic variability are unknown.
OBJECTIVE


To investigate the effects of neurally adjusted ventilatory assist (NAVA, intrinsic variability), variable pressure support ventilation (Noisy PSV, extrinsic variability) and conventional pressure-controlled ventilation (PCV) on lung and diaphragmatic function and damage in experimental acute respiratory distress syndrome (ARDS).
DESIGN


Randomised controlled animal study.
SETTING


University Hospital Research Facility.
SUBJECTS


A total of 24 juvenile female pigs.
INTERVENTIONS


ARDS was induced by repetitive lung lavage and injurious ventilation. Animals were randomly assigned to 24 h of either: 1) NAVA, 2) Noisy PSV or 3) PCV (n=8 per group). Mechanical ventilation settings followed the ARDS Network recommendations.
MEASUREMENTS


The primary outcome was histological lung damage. Secondary outcomes were respiratory variables and patterns, subject-ventilator asynchrony (SVA), pulmonary and diaphragmatic biomarkers, as well as diaphragmatic muscle atrophy and myosin isotypes.
RESULTS


Global alveolar damage did not differ between groups, but NAVA resulted in less interstitial oedema in dorsal lung regions than Noisy PSV. Gas exchange and SVA incidence did not differ between groups. Compared with Noisy PSV, NAVA generated higher coefficients of variation of tidal volume and respiratory rate. During NAVA, only 40.4% of breaths were triggered by the electrical diaphragm signal. The IL-8 concentration in lung tissue was lower after NAVA compared with PCV and Noisy PSV, whereas Noisy PSV yielded lower type III procollagen mRNA expression than NAVA and PCV. Diaphragmatic muscle fibre diameters were smaller after PCV compared with assisted modes, whereas expression of myosin isotypes did not differ between groups.
CONCLUSION


Noisy PSV and NAVA did not reduce global lung injury compared with PCV but affected different biomarkers and attenuated diaphragmatic atrophy. NAVA increased the respiratory variability; however, NAVA yielded a similar SVA incidence as Noisy PSV.
TRIAL REGISTRATION


This trial was resgistered and approved by the Landesdirektion Dresden, Germany (AZ 24-9168.11-1/2012-2).",2020,"Diaphragmatic muscle fibre diameters were smaller after PCV compared with assisted modes, whereas expression of myosin isotypes did not differ between groups.
","['acute respiratory distress syndrome', 'A total of 24 juvenile female pigs', 'University Hospital Research Facility', 'experimental acute respiratory distress syndrome (ARDS']","['Noisy PSV, NAVA', 'NAVA, 2) Noisy PSV or 3) PCV', 'NAVA', 'neurally adjusted ventilatory assist and variable pressure support', 'neurally adjusted ventilatory assist (NAVA, intrinsic variability), variable pressure support ventilation (Noisy PSV, extrinsic variability) and conventional pressure-controlled ventilation (PCV']","['respiratory variables and patterns, subject-ventilator asynchrony (SVA), pulmonary and diaphragmatic biomarkers, as well as diaphragmatic muscle atrophy and myosin isotypes', 'variation of tidal volume and respiratory rate', 'IL-8 concentration in lung tissue', 'Diaphragmatic muscle fibre diameters', 'interstitial oedema', 'lung and diaphragmatic function', 'type III procollagen mRNA expression', 'global lung injury', 'Gas exchange and SVA incidence', 'histological lung damage', 'expression of myosin isotypes', 'Global alveolar damage']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0027096', 'cui_str': 'Myosin ATPase'}, {'cui': 'C0021017', 'cui_str': 'Immunoglobulin isotype'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033240', 'cui_str': 'Procollagen Type III'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",24.0,0.110738,"Diaphragmatic muscle fibre diameters were smaller after PCV compared with assisted modes, whereas expression of myosin isotypes did not differ between groups.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scharffenberg', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Moraes', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Güldner', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huhle', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Braune', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Zeidler-Rentzsch', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kasper', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Kunert-Keil', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Patricia R M', 'Initials': 'PRM', 'LastName': 'Rocco', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kiss', 'Affiliation': 'From the Pulmonary Engineering Group, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (MS, LM, AG, RH, AB, IZR, TKo, MGdA, TKi), Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (LM, PRMR), Department of Nuclear Medicine, University Hospital Dresden at the Technische Universität Dresden (AB), Institute of Anatomy, Medical Faculty Carl Gustav Carus at the Technische Universität Dresden (MK), Department of Orthodontics, University Hospital Dresden at the Technische Universität Dresden, Dresden, Germany (IZR, CKK), Department of Surgical Sciences and Integrated Diagnostics, University of Genoa (PP) and Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy (PP).'}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001261']
2410,32660657,Daily mycoprotein consumption for one week does not affect insulin sensitivity or glycaemic control but modulates the plasma lipidome in healthy adults: a randomised controlled trial.,"Mycoprotein consumption has been shown to improve acute postprandial glycaemic control and decrease circulating cholesterol concentrations. We investigated the impact of incorporating mycoprotein into the diet on insulin sensitivity (IS), glycaemic control and plasma lipoprotein composition. Twenty healthy adults participated in a randomised, parallel-group trial in which they consumed a 7 d fully-controlled diet where lunch and dinner contained either meat/fish (CON) or mycoprotein (MYC) as the primary source of dietary protein. Oral glucose tolerance tests were performed pre- and post- intervention, and 24h continuous blood glucose monitoring was applied throughout. Fasting plasma samples were obtained pre- and post- intervention and were analysed using quantitative, targeted NMR-based metabonomics. There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS (Cederholm; 51±3 to 51±3 and 54±3 to 53±3 mg.L2/mmol.mU.min in CON and MYC, respectively; P<0.05) or 24 h glycaemic profiles. No differences between groups were found for 171 of the 224 metabonomic targets. Forty five lipid concentrations of different lipoprotein fractions (VLDL, LDL, IDL and HDL) remained unchanged in CON but showed a coordinated decrease (7-27 %; all P<0.05) in MYC. Total plasma cholesterol, free-C, LDL-C, HDL2-C, DHA and omega-3 fatty acids decreased to a larger degree in MYC (14-19 %) compared with CON (3-11 %; P<0.05). Substituting meat/fish for mycoprotein twice-daily for one week did not modulate whole-body IS or glycaemic control but resulted in changes to plasma lipid composition; the latter primarily consisting of a coordinated reduction in circulating cholesterol containing lipoproteins.",2020,"There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS (Cederholm; 51±3 to 51±3 and 54±3 to 53±3 mg.","['healthy adults', 'Twenty healthy adults']","['Mycoprotein consumption', '7 d fully-controlled diet where lunch and dinner contained either meat/fish (CON) or mycoprotein (MYC']","['Fasting plasma samples', 'lipoprotein fractions (VLDL, LDL, IDL and HDL', 'Total plasma cholesterol, free-C, LDL-C, HDL2-C, DHA and omega-3 fatty acids', 'blood glucose or serum insulin responses', 'acute postprandial glycaemic control and decrease circulating cholesterol concentrations', 'Oral glucose tolerance tests', 'insulin sensitivity or glycaemic control', 'insulin sensitivity (IS), glycaemic control and plasma lipoprotein composition']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0523559', 'cui_str': 'IDL cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1847987', 'cui_str': 'Huntington disease-like 2'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0583325', 'cui_str': 'Plasma lipoprotein measurement'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0269796,"There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS (Cederholm; 51±3 to 51±3 and 54±3 to 53±3 mg.","[{'ForeName': 'Mariana Oc', 'Initials': 'MO', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, ExeterEX1 2LU, United Kingdom.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, ExeterEX1 2LU, United Kingdom.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, ExeterEX1 2LU, United Kingdom.'}, {'ForeName': 'Tim Ja', 'Initials': 'TJ', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd., StokesleyTS9 7AB, United Kingdom.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, ExeterEX1 2LU, United Kingdom.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, ExeterEX1 2LU, United Kingdom.'}]",The British journal of nutrition,['10.1017/S0007114520002524']
2411,32660658,Docosahexaenoic acid supplementation in infants born preterm and the effect on attention at 18 months' corrected age: follow-up of a subset of the N3RO randomised controlled trial.,"Infants born preterm miss out on the peak period of in utero docosahexaenoic acid (DHA) accretion to the brain during the last trimester of pregnancy which is hypothesized to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg/day) or no DHA (soy oil - control) from within the first days of birth until 36 weeks' post menstrual age. The assessment of attention involved 3 tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child's latency of distractibility when attention was focused on a toy. The primary outcome was available for 73 infants of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0.08 s, 95% CI: -0.81, 0.97; P = 0.86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months corrected age.",2020,"There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0.08 s, 95% CI: -0.81, 0.97; P = 0.86).","['infants born preterm improves attention at 18 months corrected age', 'infants born preterm at 18 months corrected age', 'Infants born preterm', 'infants born preterm', '73 infants of the 120 infants that were eligible to participate']","['Docosahexaenoic acid supplementation', 'docosahexaenoic acid (DHA) accretion', 'Enteral DHA supplementation', 'enteral emulsion of high-dose DHA (60 mg/kg/day) or no DHA (soy oil - control', 'DHA supplementation']","[""child's latency of distractibility"", 'latency of distractibility']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0233415', 'cui_str': 'Cognitive function: distractibility'}]",120.0,0.23861,"There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0.08 s, 95% CI: -0.81, 0.97; P = 0.86).","[{'ForeName': 'Erandi', 'Initials': 'E', 'LastName': 'Hewawasam', 'Affiliation': 'Food and Nutrition Research Group, School of Agriculture, Food and Wine, The University of Adelaide, Glen Osmond, SA5064, Australia.'}, {'ForeName': 'Carmel T', 'Initials': 'CT', 'LastName': 'Collins', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, SA5006, Australia.'}, {'ForeName': 'Beverly S', 'Initials': 'BS', 'LastName': 'Muhlhausler', 'Affiliation': 'Food and Nutrition Research Group, School of Agriculture, Food and Wine, The University of Adelaide, Glen Osmond, SA5064, Australia.'}, {'ForeName': 'Lisa N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, SA5006, Australia.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Smithers', 'Affiliation': 'School of Public Health, The University of Adelaide, North Terrace, SA5005, Australia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Colombo', 'Affiliation': 'Schiefelbusch Institute for Life Span Studies and Department of Psychology, University of Kansas, Lawrence, KS66045.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, SA5006, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McPhee', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, SA5006, Australia.'}, {'ForeName': 'Jacqueline F', 'Initials': 'JF', 'LastName': 'Gould', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, SA5006, Australia.'}]",The British journal of nutrition,['10.1017/S0007114520002500']
2412,32660667,Effect of oral or intragastric delivery of the bitter tastant quinine on food intake and appetite sensations: a randomised cross-over trial.,"Stimulation of gastrointestinal taste receptors affects eating behaviour. Intraduodenal infusion of tastants leads to increased satiation and reduced food intake, whereas intraileal infusions of tastants does not affect eating behaviour. Currently, it is unknown whether oral- or intragastric administration of tastants induces a larger effect on eating behaviour. This study investigated the effects of oral- and/or intragastric administration of quinine on food intake, appetite sensations, and heart rate variability (HRV). In a blinded randomised crossover trial, 32 healthy volunteers participated in four interventions with a one-week washout: oral placebo/intragastric placebo (OPGP), oral quinine/intragastric placebo (OQGP), oral placebo/intragastric quinine (OPGQ), and oral quinine/intragastric quinine (OQGQ). On test days, 150 minutes after a standardized breakfast, subjects ingested a capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo orally. Fifty min after intervention, subjects received an ad libitum meal to measure food intake. Visual analogue scales for appetite sensations were collected and HRV measurements were performed at regular intervals. Oral- and/or intragastric delivery of the bitter tastant quinine did not affect food intake OPGP: 3273.6 (SEM 131.8) KJ, OQGP: 3072.7 (SEM 132.2) KJ, OPGQ: 3289.0 (SEM 132.6) KJ, OQGQ: 3204.1 (SEM 133.1) KJ, p=0.069). Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (p<.001 and p<.05, respectively), whereas satiation, fullness and HRV did not differ between interventions. In conclusion, sole oral sham feeding with- and sole intragastric delivery of quinine decreased desire to eat and hunger, without affecting food intake, satiation, fullness, or HRV.",2020,"Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (p<.001 and p<.05, respectively), whereas satiation, fullness and HRV did not differ between interventions.",['32 healthy volunteers participated in four interventions with a one-week washout: oral'],"['OQGQ', 'placebo/intragastric placebo (OPGP), oral quinine/intragastric placebo (OQGP), oral placebo/intragastric quinine (OPGQ), and oral quinine/intragastric quinine (OQGQ', 'OPGQ', 'OPGP', 'ad libitum meal to measure food intake', 'bitter tastant quinine', 'capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo']","['Desire to eat and hunger', 'food intake OPGP', 'food intake, appetite sensations, and heart rate variability (HRV', 'Visual analogue scales for appetite sensations', 'satiation, fullness and HRV', 'desire to eat and hunger, without affecting food intake, satiation, fullness, or HRV', 'food intake and appetite sensations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",32.0,0.383977,"Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (p<.001 and p<.05, respectively), whereas satiation, fullness and HRV did not differ between interventions.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Klaassen', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AA Venlo, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Keszthelyi', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands.'}, {'ForeName': 'Annick M E', 'Initials': 'AME', 'LastName': 'Alleleyn', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wilms', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands.'}, {'ForeName': 'Aalt', 'Initials': 'A', 'LastName': 'Bast', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AA Venlo, The Netherlands.'}, {'ForeName': 'Adrian A M', 'Initials': 'AAM', 'LastName': 'Masclee', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands.'}, {'ForeName': 'Freddy J', 'Initials': 'FJ', 'LastName': 'Troost', 'Affiliation': 'Food Innovation and Health, Centre for Healthy Eating and Food Innovation, Maastricht University, 5911 AA Venlo, The Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114520002536']
2413,32660675,Combined anthocyanins and bromelain supplement improves endothelial function and skeletal muscle oxygenation status in adults: a double-blind placebo-controlled randomized crossover clinical trial.,"Anthocyanins and bromelain have gained significant attention due to their antioxidative and anti-inflammatory properties. Both have been shown to improve endothelial function, blood pressure (BP), and oxygen utility capacity in humans, however the combination of these two and the impacts on endothelial function, BP, total antioxidant capacity (TAC), and oxygen utility capacity have not been previously investigated. The purpose of this study was to investigate the impacts of a combined anthocyanins and bromelain supplement (BE) on endothelial function, BP, TAC, oxygen utility capacity, and fatigability in healthy adults. Healthy adults (n=18, age 24±4) received BE or placebo in a randomized crossover design. Brachial artery flow-mediated dilation (FMD), BP, TAC, resting heart rate, oxygen utility capacity, and fatigability were measured pre-and post-BE and placebo intake. The BE group showed significantly increased FMD, reduced systolic BP, and improved oxygen utility capacity compared placebo group (p<0.05). Tissue saturation and oxygenated hemoglobin significantly increased following BE intake while deoxygenated hemoglobin significantly decreased (p<0.05) during exercise. Additionally, TAC was significantly increased following BE intake (p<0.05). There were no significant differences for resting heart rate, diastolic BP, or fatigability index. These results suggest that BE intake is an effective nutritional therapy for improving endothelial function, BP TAC, and oxygen utility capacity, which may be beneficial to support vascular health in humans.",2020,Tissue saturation and oxygenated hemoglobin significantly increased following BE intake while deoxygenated hemoglobin significantly decreased (p<0.05) during exercise.,"['adults', 'healthy adults', 'Healthy adults (n=18, age 24±4) received']","['Anthocyanins and bromelain', 'BE or placebo', 'combined anthocyanins and bromelain supplement (BE', 'TAC', 'Combined anthocyanins and bromelain supplement', 'placebo']","['endothelial function, BP, TAC, oxygen utility capacity, and fatigability', 'resting heart rate, diastolic BP, or fatigability index', 'endothelial function, BP TAC, and oxygen utility capacity', 'deoxygenated hemoglobin', 'FMD, reduced systolic BP, and improved oxygen utility capacity', 'Brachial artery flow-mediated dilation (FMD), BP, TAC, resting heart rate, oxygen utility capacity, and fatigability', 'endothelial function, BP, total antioxidant capacity (TAC), and oxygen utility capacity', 'Tissue saturation and oxygenated hemoglobin', 'endothelial function, blood pressure (BP), and oxygen utility capacity', 'endothelial function and skeletal muscle oxygenation status']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0006217', 'cui_str': 'Bromelains'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.183709,Tissue saturation and oxygenated hemoglobin significantly increased following BE intake while deoxygenated hemoglobin significantly decreased (p<0.05) during exercise.,"[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE68182, USA.'}, {'ForeName': 'Jeonghwa', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE68182, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE68182, USA.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE68182, USA.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'School of Public Health and Health Sciences, University of Massachusetts Amherst, Amherst, MA01003, USA.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Cellular & Integrative Physiology, University of Nebraska Medical Center, Omaha, NE68198, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Scott', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE68182, USA.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE68182, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002548']
2414,32660770,Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.,"PURPOSE


Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are common functional gastrointestinal disorders. The prevalence of constipation-related issues tends to increase with age. This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
METHODS


Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled. Efficacy end points common to all trials included changes in stool consistency (Bristol Stool Form Scale), changes in weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), and time to first CSBM and SBM. Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
FINDINGS


The pooled intention-to-treat population comprised 451 patients aged ≥65 years (mean age, 70 years) and 4364 patients aged <65 years (mean age, 41.9 years), of whom 287 and 2914, respectively, were randomized to receive plecanatide. Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years), and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years). No new safety issues were observed.
IMPLICATIONS


Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS.
GOV IDENTIFIERS


NCT01982240, NCT02122471, NCT02387359, and NCT02493452.",2020,"Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS.
","['group aged ≥65 years and both plecanatide groups aged <65 years', 'patients aged ≥65 years', 'per age group (≥65 and\xa0<65 years of age', 'Patients 65\xa0Years or Older', 'Chronic Idiopathic Constipation and Irritable Bowel Syndrome', 'patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS', '451 patients aged ≥65 years (mean age, 70 years) and 4364 patients aged <65 years (mean age, 41.9 years), of whom 287 and 2914, respectively', 'Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C']","['Plecanatide', 'plecanatide', 'SBM (plecanatide 6\xa0mg', 'placebo, plecanatide', 'placebo']","['stool consistency', 'Efficacy and safety profile', 'safety and efficacy', 'CSBM and SBM frequency', 'stool consistency (Bristol Stool Form Scale), changes in weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), and time to first CSBM and SBM']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3711911', 'cui_str': 'plecanatide'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C3711911', 'cui_str': 'plecanatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",4364.0,0.130648,"Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS.
","[{'ForeName': 'Stacy B', 'Initials': 'SB', 'LastName': 'Menees', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, USA. Electronic address: sbartnik@med.umich.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Franklin', 'Affiliation': 'Salix Pharmaceuticals Inc., Bridgewater, NJ, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'Michigan Bowel Control Program, University of Michigan, Ann Arbor, MI, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.012']
2415,32660833,The effect of astaxanthin supplementation on performance and fat oxidation during a 40 km cycling time trial.,"OBJECTIVES


This study aimed to investigate whether supplementation with 12 mg⋅day -1  astaxanthin for 7 days can improve exercise performance and metabolism during a 40 km cycling time trial.
DESIGN


A randomised, double-blind, crossover design was employed.
METHODS


Twelve recreationally trained male cyclists (VO 2peak : 56.5 ± 5.5 mL⋅kg -1 ⋅min -1 , W max : 346.8  ± 38.4 W) were recruited. Prior to each experimental trial, participants were supplemented with either 12 mg⋅day -1  astaxanthin or an appearance-matched placebo for 7 days (separated by 14 days of washout). On day 7 of supplementation, participants completed a 40 km cycling time trial on a cycle ergometer, with indices of exercise metabolism measured throughout.
RESULTS


Time to complete the 40 km cycling time trial was improved by 1.2 ± 1.7% following astaxanthin supplementation, from 70.76 ± 3.93 min in the placebo condition to 69.90 ± 3.78 min in the astaxanthin condition (mean improvement = 51 ± 71 s, p = 0.029, g = 0.21). Whole-body fat oxidation rates were also greater (+0.09 ± 0.13 g⋅min -1 , p = 0.044, g = 0.52), and the respiratory exchange ratio lower (-0.03 ± 0.04, p = 0.024, g = 0.60) between 39-40 km in the astaxanthin condition.
CONCLUSIONS


Supplementation with 12 mg⋅day -1  astaxanthin for 7 days provided an ergogenic benefit to 40 km cycling time trial performance in recreationally trained male cyclists and enhanced whole-body fat oxidation rates in the final stages of this endurance-type performance event.",2020,Whole-body fat oxidation rates were also greater (+0.09 ± 0.13,"['Twelve recreationally trained male cyclists (VO 2peak : 56.5 ± 5.5 mL⋅kg -1 ⋅min -1 , W max : 346.8\u202f ± 38.4 W) were recruited', 'recreationally trained male cyclists']","['12 mg⋅day -1  astaxanthin', '12 mg⋅day -1  astaxanthin or an appearance-matched placebo', 'astaxanthin supplementation']","['respiratory exchange ratio', 'exercise performance and metabolism', 'Whole-body fat oxidation rates', 'Time to complete the 40 km cycling time trial', 'performance and fat oxidation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]","[{'cui': 'C0052565', 'cui_str': 'astaxanthin'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",12.0,0.540191,Whole-body fat oxidation rates were also greater (+0.09 ± 0.13,"[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Department of Higher Education Sport, Loughborough College, United Kingdom. Electronic address: danny.brown@loucoll.ac.uk.'}, {'ForeName': 'Ashley R', 'Initials': 'AR', 'LastName': 'Warner', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, United Kingdom.'}, {'ForeName': 'Sanjoy K', 'Initials': 'SK', 'LastName': 'Deb', 'Affiliation': 'School of Life Sciences, University of Westminster, United Kingdom.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Gough', 'Affiliation': 'School of Health Sciences, Birmingham City University, United Kingdom.'}, {'ForeName': 'S Andy', 'Initials': 'SA', 'LastName': 'Sparks', 'Affiliation': 'Sport Nutrition and Performance Research Group, Department of Sport and Physical Activity, Edge Hill University, United Kingdom.'}, {'ForeName': 'Lars R', 'Initials': 'LR', 'LastName': 'McNaughton', 'Affiliation': 'Sport Nutrition and Performance Research Group, Department of Sport and Physical Activity, Edge Hill University, United Kingdom; Department of Sport and Movement Studies, University of Johannesburg, South Africa.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.06.017']
2416,32660842,[Effects of high frequency chest wall oscillatory (HFCWO) therapy on gas exchange and ventilation in healthy participants].,"INTRODUCTION


Chest physiotherapy is an essential part of the treatment of respiratory diseases with increased respiratory secretion and ineffective cough. To date, there have been no studies on the effect of high frequency chest wall oscillatory (HFCWO) therapy on respiratory muscle strength, ventilation and gas exchange. The aim of this study was therefore to assess these three factors in healthy participants.
METHODS


Respiratory muscle strength was measured before and immediately after HFCWO therapy in 25 healthy participants. During the treatment, we continuously measured ventilation parameters, gas exchange, oxygen saturation and heart rate. All participants underwent HFCWO sessions twice (with 24hours difference) with the same procedure. Symptoms during the session and discomfort were measured with the visual analog scale (VAS).
RESULTS


HFCWO therapy produced a change in breathing pattern with increased ventilation associated with altered gas exchange. Heart rate also increased, with no changes in oxygenation. There was no effect, either beneficial or deleterious, on the strength of respiratory muscles. Up to 20% of participants reported substantial discomfort (VAS≥5/10) during the session.
CONCLUSIONS


This study shows that, during the application of HFCWO therapy in healthy participants, ventilation and heart rate increased. However, there were undesirable effects on gas exchange with a high degree of intolerance among volunteers, with no effects on respiratory muscle strength.",2020,"There was no effect, either beneficial or deleterious, on the strength of respiratory muscles.","['healthy participants', '25 healthy participants']","['HFCWO therapy', 'high frequency chest wall oscillatory (HFCWO) therapy']","['breathing pattern with increased ventilation', 'visual analog scale (VAS', 'ventilation parameters, gas exchange, oxygen saturation and heart rate', 'respiratory muscle strength, ventilation and gas exchange', 'Heart rate', 'strength of respiratory muscles', 'substantial discomfort (VAS≥5/10', 'respiratory muscle strength', 'oxygenation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",25.0,0.0436582,"There was no effect, either beneficial or deleterious, on the strength of respiratory muscles.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Balañá Corberó', 'Affiliation': 'Servei de Pneumologia - URMAR, Hospital del Mar - IMIM, Parc de Salut Mar, Barcelona, España. Electronic address: abalana@parcdesalutmar.cat.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Admetlló Papiol', 'Affiliation': 'Servei de Pneumologia - URMAR, Hospital del Mar - IMIM, Parc de Salut Mar, Barcelona, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sancho Muñoz', 'Affiliation': 'Servei de Pneumologia - URMAR, Hospital del Mar - IMIM, Parc de Salut Mar, Barcelona, España.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kallouchi', 'Affiliation': 'Servei de Pneumologia - URMAR, Hospital del Mar - IMIM, Parc de Salut Mar, Barcelona, España.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Badenes', 'Affiliation': 'Servei de Pneumologia - URMAR, Hospital del Mar - IMIM, Parc de Salut Mar, Barcelona, España.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Rodríguez', 'Affiliation': 'Servei de Pneumologia - URMAR, Hospital del Mar - IMIM, Parc de Salut Mar, Barcelona, España; CEXS, Universitat Pompeu Fabra, Barcelona, España; CIBER de Enfermedades Respiratorias (CIBERES), ISC III, Madrid, España.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martínez-Llorens', 'Affiliation': 'Servei de Pneumologia - URMAR, Hospital del Mar - IMIM, Parc de Salut Mar, Barcelona, España; CEXS, Universitat Pompeu Fabra, Barcelona, España.'}]",Rehabilitacion,['10.1016/j.rh.2020.04.005']
2417,32660857,[Evaluation of the use of a simulation software in the learning of cardiopulmonary auscultation in undergraduate medical students].,"INTRODUCTION


Medsounds™ software allows to create an auscultation learning platform, by providing real pre-recorded cardiopulmonary sounds on virtual chests. The study aimed at comparing the skills in cardiopulmonary auscultation between students who benefited from this platform and students who did not have access to it.
METHODS


A controlled trial was conducted with 2nd year medical students randomised into three groups. Groups A, B and C received 10 h of cardiopulmonary clinical training. In addition, group B benefited from an online access to the educative platform, and group C had a demonstration of the platform during their clinical training, then an online access. The main outcome was a 3-point multiple-choice questionnaire based on 2 original case vignettes about the description of cardiopulmonary sounds. The secondary outcome was the faculty exam on high-fidelity cardiopulmonary simulator.
RESULTS


Groups A and B included 127 students, and group C 117. Students in group C had a significantly higher score than those in group A (1.72/3 versus 1.48/3; p = 0.02), without difference between the groups B and C. Students who actually had a demonstration of the platform and used it at home had a higher score than those who did not use it (1.87 versus 1.51; p = 0.01). Students who had a demonstration of the platform before using it performed a better pulmonary examination on high-fidelity simulators.
CONCLUSION


The supervised use of an online auscultation simulation software in addition to the traditional clinical training seems to improve the auscultation performances of undergraduated medical students.",2020,"Students in group C had a significantly higher score than those in group A (1.72/3 versus 1.48/3; p = 0.02), without difference between the groups B and C. Students who actually had a demonstration of the platform and used it at home had a higher score than those who did not use it (1.87 versus 1.51; p = 0.01).","['Groups A and B included 127 students, and group C 117', 'undergraduated medical students', 'undergraduate medical students', 'students who benefited from this platform and students who did not have access to it', 'Students who had a demonstration of the platform before using it performed a better pulmonary examination on high-fidelity simulators']",['simulation software'],"['3-point multiple-choice questionnaire based on 2 original case vignettes about the description of cardiopulmonary sounds', 'faculty exam on high-fidelity cardiopulmonary simulator']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]",127.0,0.0375606,"Students in group C had a significantly higher score than those in group A (1.72/3 versus 1.48/3; p = 0.02), without difference between the groups B and C. Students who actually had a demonstration of the platform and used it at home had a higher score than those who did not use it (1.87 versus 1.51; p = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malmartel', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Département de médecine générale Paris Descartes, F-75014 Paris, France. Electronic address: alexandre.malmartel@u-paris.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ecollan', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Département de médecine générale Paris Descartes, F-75014 Paris, France.'}, {'ForeName': 'M-C', 'Initials': 'MC', 'LastName': 'Bories', 'Affiliation': 'Service de chirurgie cardiovasculaire, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, F-75014 Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jablon', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Planquette', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, F-75014 Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ranque', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Service de médecine interne, Hôpital Européen Georges-Pompidou, Assistance Publique Hôpitaux de Paris, F-75014 Paris, France.'}]",La Revue de medecine interne,['10.1016/j.revmed.2020.04.012']
2418,32660977,"Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52.","OBJECTIVES


SPIRIT head-to-head (H2H) is a 52-week (Wk) trial comparing ixekizumab (IXE) with adalimumab (ADA) for simultaneous American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 responses in 566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA). IXE was superior to ADA for this primary end point at Wk24. We aimed to determine the final efficacy and safety results through Wk52 including a prespecified subgroup analysis of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use.
METHODS


SPIRIT-H2H is a Wk52 multicentre, open-label, blinded-assessor study comparing IXE and ADA in bionaïve patients with PsA. Patients were randomised 1:1 to IXE or ADA with stratification by concomitant csDMARD use and presence of moderate-to-severe plaque psoriasis. Prespecified end points at Wk24 and Wk52 included musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety.
RESULTS


A significantly higher proportion of patients treated with IXE versus ADA simultaneously achieved ACR50 and PASI100 (39% vs 26%, p<0.001), PASI100 (64% vs 41%, p<0.001) at Wk52. Efficacy of IXE and ADA was similar at Wk52 for ACR50 (49.8% vs 49.8%, p=0.924), treat-to-target outcomes, enthesitis and dactylitis resolution. Responses to IXE were consistent irrespective of concomitant csDMARD use. Significantly more patients on IXE monotherapy versus ADA monotherapy had simultaneous ACR50 and PASI100 (38% vs 19%, p=0.007), and PASI100 responses (66% vs 35%, p<0.001) at Wk52. There were no new safety findings for IXE or ADA.
CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations. IXE efficacy was consistent irrespective of concomitant csDMARD use.
TRIAL REGISTRATION NUMBER


NCT03151551.",2020,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","['566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA', 'bionaïve patients with PsA. Patients', 'patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug']","['IXE or ADA', 'conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD', 'IXE', 'ixekizumab (IXE) with adalimumab (ADA', 'ixekizumab versus adalimumab', 'IXE and ADA']","['simultaneous ACR50 and PASI100', 'musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety', 'simultaneous joint and skin improvement', 'IXE efficacy', 'PASI100 responses', 'efficacy and safety', 'ACR50 and PASI100']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0954263,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria josef.smolen@meduniwien.ac.at.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Providence St Joseph Health, Rentton, Washington, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'de la Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lingnan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Hojnik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sapin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': ""Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Caporali', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, G. Pini Hospital, Milan, Lombardia, Italy.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Rheumatology Department, Hospital Universitario Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology, Regional University Hospital Centre Tours, Tours, Centre, France.'}, {'ForeName': 'Soyi', 'Initials': 'S', 'LastName': 'Liu Leage', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sreekumar', 'Initials': 'S', 'LastName': 'Pillai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Gold Coast, Queensland, Australia.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217372']
2419,32661003,Effect of pregnancy on unbound raltegravir concentrations in the ANRS 160 Ralfe trial.,"OBJECTIVES


A population pharmacokinetic model was developed to explore the pharmacokinetics modification of unbound raltegravir during pregnancy.
METHOD


RalFe ANRS160 study was a non-randomized, open label, multicenter trial enrolling HIV-infected pregnant women receiving a combined antiretroviral regimen containing raltegravir 400 mg twice daily. Biological samples were collected during the third trimester of pregnancy (between 30 and 37 weeks of gestational age) and at postpartum (4 to 6 weeks after delivery). A population pharmacokinetic model was developed with Monolix software.
RESULT


A total of 360 plasma samples were collected from 43 women during pregnancy and postpartum. The unbound raltegravir was described by a one compartment model with a transit compartment with first order absorption, evolving either to bound raltegravir (by a linear binding to albumin), or metabolism to RAL-glucuronide or to a first order elimination, with a circadian rhythm. During pregnancy, the absorption was decreased and delayed and the raltegravir elimination clearance and glucuronidation increased by 37%. Median total and unbound AUC 0-12h  significantly decreased by 37 and 27% during pregnancy. Median total C trough  decreased significantly in the evening (28%), however median total C trough  in the morning, unbound C trough  in the morning and unbound C trough  in the evening showed a non-significant decrease, respectively 16%, 1% and 15% during pregnancy compared to the postpartum period.
CONCLUSION


This is the first study reporting the pharmacokinetics of unbound raltegravir during pregnancy. As unbound C trough  did not significantly decrease during the third trimester, the pregnancy effect on raltegravir unbound concentrations was not considered as clinically relevant.",2020,"Median total C trough  decreased significantly in the evening (28%), however median total C trough  in the morning, unbound C trough  in the morning and unbound C trough  in the evening showed a non-significant decrease, respectively 16%, 1% and 15% during pregnancy compared to the postpartum period.
","['HIV-infected pregnant women receiving a', '43 women during pregnancy and postpartum']",['combined antiretroviral regimen containing raltegravir 400 mg twice daily'],"['median total C trough', 'unbound raltegravir concentrations', 'Median total C trough', 'raltegravir elimination clearance and glucuronidation', 'Median total and unbound AUC 0-12h  significantly']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1967561', 'cui_str': 'raltegravir 400 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456695', 'cui_str': '/12h'}]",,0.0438391,"Median total C trough  decreased significantly in the evening (28%), however median total C trough  in the morning, unbound C trough  in the morning and unbound C trough  in the evening showed a non-significant decrease, respectively 16%, 1% and 15% during pregnancy compared to the postpartum period.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Service de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Déborah', 'Initials': 'D', 'LastName': 'Hirt', 'Affiliation': 'Service de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France deborah.hirt@aphp.fr.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Delma', 'Affiliation': ""Service d'Epidémiologie et Santé Publique, AP-HP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.""}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Lui', 'Affiliation': 'Service de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Benaboud', 'Affiliation': 'Service de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Lechedanec', 'Affiliation': ""Service d'Epidémiologie et Santé Publique, AP-HP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Tréluyer', 'Affiliation': 'Service de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Chenevier-Gobeaux', 'Affiliation': 'Service de Diagnostic Biologique Automatisé, AP-HP, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Arezes', 'Affiliation': ""Service d'Epidémiologie et Santé Publique, AP-HP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.""}, {'ForeName': 'Ambre', 'Initials': 'A', 'LastName': 'Gelley', 'Affiliation': 'ANRS, France Recherche Nord&Sud Sida-hiv Hépatites, Paris, France.'}, {'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'Amri', 'Affiliation': 'ANRS, France Recherche Nord&Sud Sida-hiv Hépatites, Paris, France.'}, {'ForeName': 'Saïk', 'Initials': 'S', 'LastName': 'Urien', 'Affiliation': 'Paris Descartes University, EA 7323, Paris, France.'}, {'ForeName': 'Naïm', 'Initials': 'N', 'LastName': 'Bouazza', 'Affiliation': 'Paris Descartes University, EA 7323, Paris, France.'}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': 'Paris Descartes University, EA 7323, Paris, France.'}, {'ForeName': 'Josiane', 'Initials': 'J', 'LastName': 'Warszawski', 'Affiliation': 'Inserm 1018 CESP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Ghosn', 'Affiliation': 'Service des Maladies Infectieuses et Tropicales, AP-HP, Hôpitaux Universitaires Paris Nord Val de Seine, site Bichat-Claude Bernard, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00759-20']
2420,32661006,Efficacy and safety of interferon β-1a in treatment of severe COVID-19: A randomized clinical trial.,"OBJECTIVES


To the best of our knowledge, there is no published study regarding use of IFN β-1a in the treatment of severe COVID-19. In this randomized clinical trial efficacy and safety of IFN β-1a has been evaluated in patients with severe COVID-19.
METHODS


Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir/ritonavir or atazanavir/ritonavir). Each 44 micrograms/ml (12 million IU/ml) of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted 39 patients that received only the national protocol medications. Primary outcome of study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization.
RESULTS


Between 29 th  February to 3 rd  April 2020, 92 patients were recruited that finally 42 patients in the IFN group and 39 patients in the control group completed the study. As primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 vs. 8.3 ± 4.9 days respectively, P=0.95). On day 14, 66.7% vs. 43.6% of patients in the IFN group and the control group were discharged, respectively (OR= 2.5; 95% CI: 1.05- 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% vs. 43.6% respectively, p= 0.015). Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
CONCLUSION


Although IFN did not change time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality.",2020,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","['Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications ', 'severe COVID-19', 'Between 29 th  February to 3 rd  April 2020, 92 patients were recruited that finally 42 patients in the IFN group and 39 patients in the control group completed the study', 'patients with severe COVID-19']","['hydroxychloroquine plus lopinavir/ritonavir or atazanavir/ritonavir', 'IFN β-1a', 'IFN', 'interferon β-1a']","['reduced mortality', 'time to the clinical response', 'Efficacy and safety', 'duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization', 'time to reach clinical response', '28-day mortality', 'discharge rate', '28-day overall mortality']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",92.0,0.186626,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","[{'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran Khalilih@sina.tums.ac.ir.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Abbasian', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kazemzadeh', 'Affiliation': 'Advance Thoracic Research Center, Occupational Sleep Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01061-20']
2421,32661104,Impact of pharmacist interventions on drug-related problems in general surgery patients: a randomised controlled trial.,"OBJECTIVES


The inappropriate use of medications is harmful and is a common issue in hospitalised patients. Patients hospitalised in general surgery wards are usually at high risk for drug-related problems (DRPs). This randomised controlled trial aimed to explore the value of a pharmaceutical care service conducted in general surgery wards in the identification and reduction of DRPs in comparison with standard medical care.
METHODS


This study was conducted in general surgery wards including abdominal, cardiovascular, vascular, endocrine, orthopaedic and oncological surgeries at one of the largest teaching hospitals in Jordan over a period of 6 months. Recruited patients were randomised into intervention or control groups. Clinical pharmacists assessed patients' DRPs and submitted recommendations to resolve the identified DRPs in the intervention group.
RESULTS


Patients in the intervention group (n=63) and the control group (n=60) had a mean age of 55±14.4 years, with 52.0% being women. A total of 1062 DRPs were identified, with a mean of 8.6±3.6 per patient (intervention group, 8.65±4.2; control group, 8.62±2.6; p=0.56). The commonly identified DRPs included safety (20.2%) and efficacy (19.0%) issues. The acceptance rate for pharmacists' recommendations by physicians was very high (90%) with a good DRP correction rate of 58.9% during patients' hospital stay. The value of pharmaceutical care was significantly reflected in the achievement of the therapeutic outcomes and prevention of morbidity (resolved/improved or prevented) of 68.2% (24.2%+44%) in the intervention group compared with 19.2% (12.4%+6.8%) in the control group (p<0.001).
CONCLUSIONS


This study shows that DRPs are common among general surgery patients in Jordan, especially those related to drug safety and efficacy. Pharmacists' recommendations contributed substantially to resolving most of the identified DRPs and had a significant impact on improving medications used in general surgery patients.",2020,The acceptance rate for pharmacists' recommendations by physicians was very high (90%) with a good DRP correction rate of 58.9% during patients' hospital stay.,"['general surgery patients in Jordan', 'hospitalised patients', 'Patients in the intervention group (n=63) and the control group (n=60) had a mean age of 55±14.4 years, with 52.0% being women', 'general surgery wards including abdominal, cardiovascular, vascular, endocrine, orthopaedic and oncological surgeries at one of the largest teaching hospitals in Jordan over a period of 6 months', 'general surgery patients', 'Patients hospitalised in general surgery wards are usually at high risk for drug-related problems (DRPs']",['pharmacist interventions'],"['acceptance rate', 'therapeutic outcomes and prevention of morbidity', 'DRP correction rate']","[{'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0675739', 'cui_str': 'DENR protein, human'}]",1062.0,0.116553,The acceptance rate for pharmacists' recommendations by physicians was very high (90%) with a good DRP correction rate of 58.9% during patients' hospital stay.,"[{'ForeName': 'Salah', 'Initials': 'S', 'LastName': 'AbuRuz', 'Affiliation': 'Department of Pharmacology and Therapeutics, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, Abu Dhabi, United Arab Emirates saburuz@uaeu.ac.ae.'}, {'ForeName': 'Deema', 'Initials': 'D', 'LastName': 'Jaber', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Zarqa University, Zarqa, Amman, Jordan.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Basheti', 'Affiliation': 'Department of Clinical Pharmacy and Therapeutics, Applied Science University, Amman, Jordan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Sadeq', 'Affiliation': 'College of Pharmacy, Al Ain University, Al Ain, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Mosab', 'Initials': 'M', 'LastName': 'Arafat', 'Affiliation': 'College of Pharmacy, Al Ain University, Al Ain, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'AlAhmad', 'Affiliation': 'College of Pharmacy, Al Ain University, Al Ain, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Said', 'Affiliation': 'College of Pharmacy, Al Ain University, Al Ain, Abu Dhabi, United Arab Emirates.'}]",European journal of hospital pharmacy : science and practice,['10.1136/ejhpharm-2020-002206']
2422,32653022,Effect of unilateral pulsed jet lavage prior to vertebroplasty on the intravertebral pressure and cement distribution.,"BACKGROUND


Percutaneous vertebroplasty is the most common treatment for osteoporotic vertebral compression fracture. However, the morbidity of vertebroplasty-related complications, such as cement leakage, remains high. We tested a new technique of unilateral pulsed jet lavage and investigated its effect on the intravertebral pressure and bone cement distribution.
METHODS


Thirty lumbar vertebrae (L1-L5) from six cadaver spines were randomly allocated into two groups (with and without irrigation). Prior to vertebroplasty, pulsed jet lavage was performed through one side of the pedicle by using a novel cannula with two concentric conduits to remove the fat and bone marrow of the vertebral bodies in the group with irrigation. The control group was not irrigated. Then, standardized vertebroplasty was performed in the vertebral bodies in both groups. Changes in the intravertebral pressure during injection were recorded. Computed tomography (CT) was performed to observe the cement distribution and extravasations, and the cement mass volume (CMV) was calculated.
RESULTS


During cement injection, the average maximum intravertebral pressure of the unirrigated group was higher than that of the irrigated group (4.92 kPa versus 2.22 kPa, P < 0.05). CT scans showed a more homogeneous cement distribution with less CMV (3832 mm 3  vs. 4344 mm 3 , P < 0.05) and less leakage rate (6.7% vs. 46.7%, P < 0.05) in the irrigated group than in the control group.
CONCLUSIONS


Unilateral pulsed jet lavage can reduce intravertebral pressure and lower the incidence of cement leakage during vertebroplasty. An enhanced bone cement distribution can also be achieved through this lavage system.",2020,"CT scans showed a more homogeneous cement distribution with less CMV (3832 mm 3  vs. 4344 mm 3 , P < 0.05) and less leakage rate (6.7% vs. 46.7%, P < 0.05) in the irrigated group than in the control group.
","['Thirty lumbar vertebrae (L1-L5) from six cadaver spines', 'osteoporotic vertebral compression fracture']","['Computed tomography (CT', 'unilateral pulsed jet lavage prior to vertebroplasty']","['intravertebral pressure', 'leakage rate', 'average maximum intravertebral pressure', 'intravertebral pressure and cement distribution']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",,0.0140366,"CT scans showed a more homogeneous cement distribution with less CMV (3832 mm 3  vs. 4344 mm 3 , P < 0.05) and less leakage rate (6.7% vs. 46.7%, P < 0.05) in the irrigated group than in the control group.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Qiaohui', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China. zhengyanspine@163.com.""}, {'ForeName': 'Ziqun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Spine Surgery, Second Xiangya Hospital, Central South University, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Pediatric Surgery, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, People's Republic of China.""}, {'ForeName': 'Penghui', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Suomao', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Yonghao', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}, {'ForeName': 'Wanlong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedics, Qilu Hospital, Shandong University, Jinan, Shandong, People's Republic of China.""}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01779-3']
2423,32653025,"Impact of a smartphone application (KAIA COPD app) in combination with Activity Monitoring as a maintenance prOgram following PUlmonary Rehabilitation in COPD: the protocol for the AMOPUR Study, an international, multicenter, parallel group, randomized, controlled study.","BACKGROUND


Increasing physical activity (PA) is considered to be an important factor for the efficient management of chronic obstructive pulmonary disease (COPD). Successful methods required to achieve improvements in PA following pulmonary rehabilitation (PR), however, are rarely reported. Therefore, we will conduct this trial to evaluate the effectiveness of using a COPD management program delivered to the patient via the KAIA COPD app, a mobile medical application, after the completion of PR.
METHODS


This is the protocol for a randomized, controlled, open-label, multicentered trial that will be carried out at inpatient PR hospital centers in Germany and Switzerland. The interventions will involve the use of the KAIA COPD app program (Arm 1) or an active comparator, i.e., usual care (Arm 2). Patients completing an in-hospital PR program and consenting to participate in the study will be screened with the inclusion and exclusion criteria and enrolled in the study. After fulfilling the screening requirements, the patients will be randomized into one of the two arms with parallel group assignment in a 1:1 ratio. The training program will be delivered to the participants grouped in Arm 1 via the KAIA COPD app and to participants grouped in Arm 2 via the regular recommendations or standard of care by the PI. In total, 104 participants will be included in the trial. The treatment period will last for 24 weeks. Electronic versions of questionnaires will be used to collect patient-reported assessments remotely. The primary outcome measure is the change in physical activity of the intervention group in comparison to the control group, measured over 1 week as the mean steps per day with a Polar A 370 activity tracker, from baseline (end of PR) to the 6-month follow-up. The secondary outcome measures are functional exercise capacity, health status, sleep quality, exacerbation rate, and depression and anxiety symptoms assessed at several intervals.
DISCUSSION


This study seeks to prove the effects of the KAIA COPD mobile application in COPD patients after PR. The app offers educational, exercise training plus activity monitoring and motivational programs that can be easily implemented in the patient's home setting, enabling patients to maintain the effects that are typically elicited in the short term after pulmonary rehabilitation for the long term.
TRIAL REGISTRATION


German Clinical Trials Register ( DRKS00017275 ). Protocol version 2.0 dated 3 June 2019.",2020,"The secondary outcome measures are functional exercise capacity, health status, sleep quality, exacerbation rate, and depression and anxiety symptoms assessed at several intervals.
","['COPD patients after PR', 'PUlmonary Rehabilitation in COPD', 'inpatient PR hospital centers in Germany and Switzerland', '104 participants will be included in the trial', 'chronic obstructive pulmonary disease (COPD', 'Patients completing an in-hospital PR program and consenting to participate in the study will be screened with the inclusion and exclusion criteria and enrolled in the study']","['smartphone application (KAIA COPD app', 'KAIA COPD mobile application', 'COPD management program']","['functional exercise capacity, health status, sleep quality, exacerbation rate, and depression and anxiety symptoms assessed at several intervals', 'change in physical activity']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0851408', 'cui_str': 'Changes in physical activity'}]",104.0,0.0711928,"The secondary outcome measures are functional exercise capacity, health status, sleep quality, exacerbation rate, and depression and anxiety symptoms assessed at several intervals.
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Spielmanns', 'Affiliation': 'Pneumologie, Zürcher RehaZentren Klinik Wald, Faltigbergstrasse 7, 8636, Wald, Switzerland. spielmanns@me.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Boeselt', 'Affiliation': 'Department of Pulmonary Rehabilitation, Philipps-University of Marburg, German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Huber', 'Affiliation': 'Fa. Kaia Health GmbH, Siegfriedstr.8, 80797, Munich, Germany.'}, {'ForeName': 'Pawandeep', 'Initials': 'P', 'LastName': 'Kaur Bollinger', 'Affiliation': 'Fa. Kaia Health GmbH, Siegfriedstr.8, 80797, Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ulm', 'Affiliation': 'Unabhängiges statistische Beratung Berhard Ulm, Kochelseestr 11, D-81371, Munich, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Peckaka-Egli', 'Affiliation': 'Pneumologie, Zürcher RehaZentren Klinik Wald, Faltigbergstrasse 7, 8636, Wald, Switzerland.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schoendorf', 'Affiliation': 'Pneumologie, Zürcher RehaZentren Klinik Wald, Faltigbergstrasse 7, 8636, Wald, Switzerland.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Gloeckl', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany.'}, {'ForeName': 'A Rembert', 'Initials': 'AR', 'LastName': 'Koczulla', 'Affiliation': 'Department of Pulmonary Rehabilitation, Philipps-University of Marburg, German Center for Lung Research (DZL), Marburg, Germany.'}]",Trials,['10.1186/s13063-020-04538-1']
2424,32653029,Study design to evaluate a group-based therapy for support persons of adults on buprenorphine/naloxone.,"BACKGROUND


Opioid use disorders (OUDs) have devastating effects on individuals, families, and communities. While medication treatments for OUD save lives and are increasingly utilized, rates of treatment dropout are very high. In addition, most existing medication treatments for OUD may often neglect the impact of untreated OUD on relationships and ignore the potential role support persons (SPs) could have on encouraging long-term recovery, which can also impact patient treatment retention.
METHODS/DESIGN


The current study adapts Community Reinforcement and Family Training (CRAFT) for use with SPs (family member, spouse or friend) of patients using buprenorphine/naloxone (buprenorphine) in an outpatient community clinic setting. The study will evaluate whether the adapted intervention, also known as integrating support persons into recovery (INSPIRE), is effective in increasing patient retention on buprenorphine when compared to usual care. We will utilize a two-group randomized design where patients starting or restarting buprenorphine will be screened for support person status and recruited with their support person if eligible. Support persons will be randomly assigned to the INSPIRE intervention, which will consist of 10 rolling group sessions led by two facilitators. Patients and SPs will each be assessed at baseline, 3 months post-baseline, and 12 months post-baseline. Patient electronic medical record data will be collected at six and 12 months post-baseline. We will examine mechanisms of intervention effectiveness and also conduct pre/post-implementation surveys with clinic staff to assess issues that would affect sustainability.
DISCUSSION


Incorporating the patient's support system may be an important way to improve treatment retention in medication treatments for OUD. If SPs can serve to support patient retention, this study would significantly advance work to help support the delivery of effective treatments that prevent the devastating consequences associated with OUD. Trial registration This study was registered with ClinicalTrials.gov, NCT04239235. Registered 27 January 2020, https://clinicaltrials.gov/ct2/show/NCT04239235 .",2020,"The study will evaluate whether the adapted intervention, also known as integrating support persons into recovery (INSPIRE), is effective in increasing patient retention on buprenorphine when compared to usual care.","['outpatient community clinic setting', 'support persons of adults on', 'Registered 27 January 2020', 'The current study adapts Community Reinforcement and Family Training (CRAFT) for use with SPs (family member, spouse or friend) of patients using']","['buprenorphine/naloxone', 'buprenorphine', 'buprenorphine/naloxone (buprenorphine']",[],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]",[],,0.0736913,"The study will evaluate whether the adapted intervention, also known as integrating support persons into recovery (INSPIRE), is effective in increasing patient retention on buprenorphine when compared to usual care.","[{'ForeName': 'Karen Chan', 'Initials': 'KC', 'LastName': 'Osilla', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA. karenc@rand.org.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Ecola', 'Affiliation': 'RAND Corporation, 1100 South Hayes Street, VA, 22202, Arlington, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hurley', 'Affiliation': 'LA County Department of Health Services, UCLA Department of Family Medicine, 10780 Santa Monica Blvd., Suite 105, Los Angeles, CA, 90025, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Manuel', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, 401 Parnassus Ave, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ober', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Paddock', 'Affiliation': 'NORC at the University of Chicago, 55 East Monroe St, 31st Floor, Chicago, IL, 60603, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-020-00199-2']
2425,32653031,Oral intermittent vitamin D substitution: influence of pharmaceutical form and dosage frequency on medication adherence: a randomized clinical trial.,"BACKGROUND


To assess adherence to and preference for vitamin D substitution with different pharmaceutical forms and frequencies of administration.
METHODS


A focus group of stakeholders aimed at preparing the design of an interventional, randomized, cross-over study with 2 × 2 groups obtaining monthly or weekly vitamin D products in liquid or solid form for 3 months each. Dosage corresponds to cumulated amount of recommended 800 IU daily (5.600 IU weekly / 24.000 IU monthly). Main inclusion criteria were a vitamin D serum value < 50 nmol/l and age ≥ 18 years. Primary endpoint was adherence, secondary endpoints were preferences and vitamin D serum levels.
RESULTS


The focus group reached consensus for preference of a monthly administration of solid forms to adults. Full datasets were obtained from 97 participants. Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration. Vitamin D levels increased significantly (p < 0.001) in all participants. An optimal value of > 75 nmol/l was achieved by 32% after 3 months and by 50% after 6 months. Preferred formulation was solid form (tablets, capsules) for 71% of participants, and preferred dosage frequency was monthly for 39% of participants.
CONCLUSIONS


Monthly oral vitamin D in solid form lead to the highest adherence, and is preferred by the participants. However, only one third of study participants achieved values in the optimal range of > 75 nmol/l cholecalciferol using weekly or monthly administration providing an average daily cholecalciferol dose of 800 IU.
TRIAL REGISTRATION


NCT03121593 | SNCTP000002251 . Registered 30. May 2017,. Prospectively registered.",2020,Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration.,['Main inclusion criteria were a vitamin D serum value <\u200950\u2009nmol/l and age\u2009≥\u200918\u2009years'],['Oral intermittent vitamin D substitution'],"['Vitamin D levels', 'preferences and vitamin D serum levels', 'Adherence', 'medication adherence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.251136,Adherence was significantly higher with monthly (79.5-100.0%) than weekly (66.4-98.1%) administration.,"[{'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Rothen', 'Affiliation': 'Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland. jp.rothen@unibas.ch.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University Hospital, Basel, Switzerland.'}, {'ForeName': 'Philipp N', 'Initials': 'PN', 'LastName': 'Walter', 'Affiliation': 'Solothurn Hospitals, Institute for Laboratory Medicine, Olten, Switzerland.'}, {'ForeName': 'Kurt E', 'Initials': 'KE', 'LastName': 'Hersberger', 'Affiliation': 'Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Arnet', 'Affiliation': 'Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel, Petersplatz 14, Postfach 2148, CH-4001, Basel, Switzerland.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00430-5']
2426,32653209,Long-term treatment of Japanese cedar pollinosis with Japanese cedar pollen SLIT drops and persistence of treatment effect: A post-marketing clinical trial.,"BACKGROUND


There have been no reports of treatment effect persistence after long-term sublingual immunotherapy (SLIT) in patients with Japanese cedar (JC) pollinosis. Therefore, we conducted a post-marketing clinical trial to investigate the efficacy, safety, and effect persistence of JC pollen SLIT drops after approximately 3 years of treatment.
METHODS


This was an open-label trial of 233 patients with JC pollinosis who were treated with JC pollen SLIT drops for approximately 3 years (2015-2017) and followed-up for an additional 2 years (2018-2019). Efficacy and effect persistence were evaluated using nasal and ocular symptom scores, daily use of rescue medication, and Japanese Rhinoconjunctivitis Quality of Life Questionnaire scores recorded during the JC pollen dispersal season of each year. Safety was evaluated by monitoring adverse events and adverse drug reactions.
RESULTS


The mean combined total nasal symptom and medication score (range 0-18) during the peak symptom periods of 2015 through 2019 were 5.47 ± 3.38, 4.52 ± 3.13, 3.58 ± 2.63, 5.28 ± 4.01, and 6.83 ± 4.65, respectively. The percentage of patients who used no rescue medications during the same periods was 64.8%, 75.2%, 80.3%, 63.7%, and 50.3%, respectively. A total of 138 adverse drug reaction incidents were recorded in 73 of the 233 patients (31.3%), of which 134 incidents (97.1%) were mild in severity.
CONCLUSIONS


JC pollen SLIT drops demonstrated treatment duration-dependent efficacy with effects that persisted for 2 years after cessation of treatment. The drug had a favorable safety profile over the 5-year study period.",2020,"A total of 138 adverse drug reaction incidents were recorded in 73 of the 233 patients (31.3%), of which 134 incidents (97.1%) were mild in severity.
","['patients with Japanese cedar (JC) pollinosis', 'Japanese cedar pollinosis with Japanese cedar pollen', '233 patients with JC pollinosis who were treated with JC pollen SLIT drops for approximately 3 years (2015-2017) and followed-up for an additional 2 years (2018-2019']","['sublingual immunotherapy (SLIT', 'SLIT', 'JC pollen SLIT']","['Efficacy and effect persistence', 'nasal and ocular symptom scores, daily use of rescue medication, and Japanese Rhinoconjunctivitis Quality of Life Questionnaire scores', 'adverse events and adverse drug reactions', 'mean combined total nasal symptom and medication score', '138 adverse drug reaction incidents']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0996622', 'cui_str': 'Cedar, Japanese'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0440380', 'cui_str': 'Japanese cedar pollen'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0440380', 'cui_str': 'Japanese cedar pollen'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",233.0,0.0971165,"A total of 138 adverse drug reaction incidents were recorded in 73 of the 233 patients (31.3%), of which 134 incidents (97.1%) were mild in severity.
","[{'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nihon University School of Medicine, Tokyo, Japan; Koganeibashi Sakura Clinic, Tokyo, Japan.'}, {'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Okubo', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Nakamura ENT Clinic, Kanagawa, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Sawaki', 'Affiliation': 'Kikuna Otolaryngology Clinic, Kanagawa, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kitagou', 'Affiliation': 'Kitagou Otorhinolaryngology Clinic, Kanagawa, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Idei', 'Affiliation': 'IDEI ENT Clinic, Kanagawa, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Torii Pharmaceutical Co., Ltd, Tokyo, Japan. Electronic address: shinya.kaneko@torii.co.jp.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Torii Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Torii Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan; Chiba Rousai Hospital, Chiba, Japan.'}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.05.008']
2427,32653248,Modifying bowling kinematics in cricket pace bowlers with exercise-based injury prevention: A cluster-randomised controlled trial.,"OBJECTIVES


Undesirable bowling kinematics can increase the risk of low back injury. This study investigated if an exercise-based injury prevention program (IPP) could modify bowling kinematics in community-level adolescent pace bowlers.
DESIGN


Cluster-randomised controlled trial.
METHODS


Pace bowlers from eight cricket organisations were cluster-randomised into an intervention or control group. At baseline and follow-up sessions biomechanical bowling data were collected. Between sessions, the intervention group completed an eight-week IPP while the control continued their normal cricket activity. Treatment effects (95% CI) were estimated with linear mixed models.
RESULTS


There were significant treatment effects favouring the intervention group for shoulder counter-rotation (-3.8°; -7.2° to -0.3°) and lateral trunk flexion relative to the pelvis (-2.2°; -4.0° to -0.5°). Shoulder counter-rotation also increased in the control group by 2.2° (Cohen's d=0.22). There were no effects of the intervention on: lateral trunk flexion at front foot contact (FFC) (1.2°; -2.5° to 4.8°), lateral trunk flexion at ball release (BR) (-0.5°; -3.0° to 2.0°), pelvis rotation at FFC (0.9°; -4.0° to 2.2°), pelvis rotation at BR (-1.1°; -5.7° to 3.6°), front hip angle at FFC (1.6°; -3.6° to 6.7°), front hip angle at BR (-1.6°; -5.0° to 1.9°), front knee angle at FFC (-1.1°; -4.5° to 2.3°), front knee angle at BR (1.7°; -5.6° to 9.1°), or ball velocity (1.1kmh -1 ; -7.5kmh -1  to 9.7kmh -1 ).
CONCLUSIONS


The IPP maintained shoulder counter-rotation and lateral trunk flexion relative to the pelvis in the intervention group and this could attenuate injury risk. No treatment effects were observed for lower-limb kinematics.",2020,There were significant treatment effects favouring the intervention group for shoulder counter-rotation (-3.8°; -7.2° to -0.3°) and lateral trunk flexion relative to the pelvis (-2.2°; -4.0° to -0.5°).,['Pace bowlers from eight cricket organisations were cluster-randomised into an intervention or control group'],"['exercise-based injury prevention', 'exercise-based injury prevention program (IPP']","['lateral trunk flexion relative to the pelvis', 'Shoulder counter-rotation', 'lower-limb kinematics', 'pelvis rotation at FFC', 'pelvis rotation at BR ', 'lateral trunk flexion at ball release (BR', 'shoulder counter-rotation', 'lateral trunk flexion at front foot contact (FFC']","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0018288', 'cui_str': 'Cricket'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.0439172,There were significant treatment effects favouring the intervention group for shoulder counter-rotation (-3.8°; -7.2° to -0.3°) and lateral trunk flexion relative to the pelvis (-2.2°; -4.0° to -0.5°).,"[{'ForeName': 'Mitchell R L', 'Initials': 'MRL', 'LastName': 'Forrest', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Perth, WA, Australia.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Hebert', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Faculty of Kinesiology, University of New Brunswick, Fredericton, NB, Canada.'}, {'ForeName': 'Brendan R', 'Initials': 'BR', 'LastName': 'Scott', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Perth, WA, Australia.'}, {'ForeName': 'Alasdair R', 'Initials': 'AR', 'LastName': 'Dempsey', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Perth, WA, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.06.014']
2428,32653324,"Re: Michael S. Hofman, Nathan Lawrentschuk, Roslyn J. Francis, et al. Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multi-centre Study. Lancet 2020;395:1208-16: PSMA Positron Emission Tomography: One Tracer Fixes Them All!",,2020,,['Patients with High-risk Prostate Cancer'],"['Curative-intent Surgery or Radiotherapy (proPSMA', 'PSMA Positron Emission Tomography', 'Prostate-specific Membrane Antigen PET-CT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0263993,,"[{'ForeName': 'Egesta', 'Initials': 'E', 'LastName': 'Lopci', 'Affiliation': 'Nuclear Medicine Department, Humanitas Clinical and Research Hospital - IRCCS, Rozzano, Italy. Electronic address: egesta.lopci@humanitas.it.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Lazzeri', 'Affiliation': 'Urology Department, Humanitas Clinical and Research Hospital - IRCCS, Rozzano, Italy.'}]",European urology,['10.1016/j.eururo.2020.06.054']
2429,32653333,Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial.,"STUDY OBJECTIVE


Acute urticaria is a frequent presentation in emergency departments (EDs), urgent care centers, and other clinical arenas. Treatment options are limited if diphenhydramine is the only intravenous antihistamine offered because of its short duration of action and well-known adverse effects. We evaluate cetirizine injection, the first second-generation injectable antihistamine, for acute urticaria in this multicenter, randomized, noninferiority, phase 3 clinical trial.
METHODS


Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous antihistamine were randomized to either intravenous cetirizine 10 mg or intravenous diphenhydramine 50 mg. The primary endpoint was the 2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers as key secondary endpoints. Frequency of sedation and anticholinergic adverse effects were also recorded.
RESULTS


Among 262 enrolled patients, the 2-hour pruritus score change from baseline for intravenous cetirizine was statistically noninferior to that for intravenous diphenhydramine (-1.6 versus -1.5; 95% confidence interval -0.1 to 0.3), and in favor of cetirizine. Treatment differences also favored cetirizine for mean time spent in treatment center (1.7 versus 2.1 hours; P=.005), return to treatment center (5.5% versus 14.1%; P=.02), lower change from baseline sedation score at 2 hours (0.1 versus 0.5; P=.03), and adverse event rate (3.9% versus 13.3%).
CONCLUSION


Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.",2020,"Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.","['Acute Urticaria', '262 enrolled patients', 'Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous']","['antihistamine', 'intravenous cetirizine 10 mg or intravenous diphenhydramine', 'diphenhydramine', 'cetirizine', 'Intravenous Cetirizine', 'Diphenhydramine']","['baseline sedation score', 'adverse event rate', 'Frequency of sedation and anticholinergic adverse effects', '2-hour pruritus score change', '2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers', 'mean time spent']","[{'cui': 'C0234935', 'cui_str': 'Acute urticaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1551285', 'cui_str': 'Urgent care clinic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",262.0,0.0952898,"Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.","[{'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: benjamin.abella@pennmedicine.upenn.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Berger', 'Affiliation': 'Allergy and Asthma Associates of Southern California, Mission Viejo, CA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Blaiss', 'Affiliation': 'Department of Pediatrics, Medical College of Georgia at Augusta University, Augusta, GA.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Stiell', 'Affiliation': 'Department of Emergency Medicine, University of Ottawa and Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Herres', 'Affiliation': 'Department of Emergency Medicine, Einstein Healthcare Network, Philadelphia, PA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Moellman', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Suner', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kessler', 'Affiliation': 'Department of Emergency Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Klausner', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Caterino', 'Affiliation': 'Department of Emergency Medicine, The Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'TerSera Therapeutics, Deerfield, IL.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.05.025']
2430,32653359,The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial.,"OBJECTIVE


This study investigated the effects of three auditory interventions; white noise, recorded mother's voice, and MiniMuffs, applied during a heel lance on pain and comfort in premature infants in the neonatal intensive care units.
DESIGN AND METHODS


This experimental, parallel, randomised controlled research was conducted in a state hospital tertiary-level neonatal intensive care unit. The sample comprised sixty-four premature infants with gestational ages of 31-36 weeks. The infants were randomly assigned to four groups: i) white noise, ii) recorded mother's voice, iii) MiniMuffs, and iv) control. Pain and comfort of newborns were evaluated according to the Neonatal Infant Pain Scale (NIPS) and the COMFORTneo scale. Oxygen saturation, heart rate, and crying time were also measured.
RESULTS


The mean of oxygen saturation levels in the white noise, recorded mother's voice, and MiniMuffs group were higher than the control group. The heart rate, crying time, mean NIPS score, COMFORTneo score of the premature neonates in the white noise, recorded mother's voice, and MiniMuffs groups were significantly lower than the control group (p < .001).
CONCLUSION


Auditory interventions used during heel lance reduce the pain and increase the comfort of the premature infants. White noise is extremely effective in preventing infants's pain.",2020,"The mean of oxygen saturation levels in the white noise, recorded mother's voice, and MiniMuffs group were higher than the control group.","['state hospital tertiary-level neonatal intensive care unit', 'premature infants in the neonatal intensive care units', 'sample comprised sixty-four premature infants with gestational ages of 31-36\xa0weeks', 'premature newborns in the neonatal intensive care unit']","[""white noise, ii) recorded mother's voice, iii) MiniMuffs, and iv) control"", 'auditory interventions', ""three auditory interventions; white noise, recorded mother's voice, and MiniMuffs, applied during a heel lance"", 'Auditory interventions']","['pain and comfort', 'Pain and comfort of newborns', 'Neonatal Infant Pain Scale (NIPS) and the COMFORTneo scale', ""heart rate, crying time, mean NIPS score, COMFORTneo score of the premature neonates in the white noise, recorded mother's voice"", 'Oxygen saturation, heart rate, and crying time', 'mean of oxygen saturation levels', 'pain']","[{'cui': 'C0020026', 'cui_str': 'State Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0522666', 'cui_str': 'Lance'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0553415,"The mean of oxygen saturation levels in the white noise, recorded mother's voice, and MiniMuffs group were higher than the control group.","[{'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Kahraman', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey. Electronic address: ayse.kahraman@ege.edu.tr.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey.'}, {'ForeName': 'Melek', 'Initials': 'M', 'LastName': 'Akar', 'Affiliation': 'Izmir Tepecik Training and Research Hospital, Division of Neonatology, İzmir, Turkey.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Sipahi', 'Affiliation': 'Izmir Tepecik Training and Research Hospital, Division of Neonatology, İzmir, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Bal Yılmaz', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey.'}, {'ForeName': 'Zümrüt', 'Initials': 'Z', 'LastName': 'Başbakkal', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102904']
2431,32653414,"Re: Toni K. Choueiri, Daniel Y.C. Heng, Jae Lyun Lee, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. In press. https://doi.org/10.1001/jamaoncol.2020.2218: SAVOIR: From Own Goal to Winning Goal?",,2020,,"['Patients With MET-Driven Papillary Renal Cell Carcinoma', 'https://doi.org/10.1001/jamaoncol.2020.2218']","['SAVOIR', 'Savolitinib vs Sunitinib']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}]",[],,0.0560533,,"[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: francesco.massari@aosp.bo.it.'}]",European urology oncology,['10.1016/j.euo.2020.06.008']
2432,32653445,Insufficient Calorie Intake Worsens Post-Discharge Quality of Life and Increases Readmission Burden in Heart Failure.,"OBJECTIVES


The purpose of this study was to evaluate the relationship between calorie intake and post-discharge outcomes in hospitalized patients with heart failure (HF).
BACKGROUND


Malnutrition increases adverse outcomes in HF, and dietary sodium restriction may inadvertently worsen nutritional intake.
METHODS


In a dietary intervention trial, baseline nutritional intake in HF inpatients was estimated using the Block Food Frequency Questionnaire (FFQ), and the Nutritional Risk Index (NRI) was calculated. Insufficient calorie intake was defined as <90% of metabolic needs, and a 15-point micronutrient deficiency score was created. Adjusted linear, logistic, and negative binomial regression were used to evaluate associations between insufficient calorie intake and quality of life (using the Kansas City Cardiomyopathy Questionnaire Clinical Summary [KCCQ-CS]), readmission risk, and days rehospitalized over 12 weeks.
RESULTS


Among 57 participants (70 ± 8 years of age; 31% female; mean body mass index 32 ± 8 kg/m 2 ); median sodium and calorie intake amounts were 2,987 (interquartile range [IQR]: 2,160 to 3,540) mg/day and 1,602 (IQR: 1,201 to 2,142) kcal/day, respectively; 11% of these patients were screened as malnourished by the NRI. All patients consuming <2,000 mg/day sodium had insufficient calorie intake; this group also more frequently had dietary micronutrient and protein deficiencies. At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio [OR] 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio [IRR]: 31.3; 95% CI: 4.3 to 229.3).
CONCLUSIONS


Despite a high prevalence for obesity and rare overt malnutrition, insufficient calorie intake was associated with poorer post-discharge quality of life and increased burden of readmission in patients with HF. Inpatient dietary assessment could improve readmission risk stratification and identify patients for nutritional intervention. (Geriatric Out of Hospital Randomized Meal Trial in Heart Failure [GOURMET-HF] NCT02148679).",2020,"At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio [OR] 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio [IRR]: 31.3; 95% CI: 4.3 to 229.3).
","['Heart\xa0Failure', 'patients with HF', '57 participants (70 ± 8 years of age; 31% female; mean body mass index 32 ± 8\xa0kg/m 2 ); median sodium and calorie intake amounts were 2,987 (interquartile range [IQR]: 2,160 to 3,540) mg/day and 1,602', 'hospitalized patients with heart failure (HF']",[],"['burden of readmission', 'insufficient calorie intake and quality of life (using the Kansas City Cardiomyopathy Questionnaire Clinical Summary [KCCQ-CS]), readmission risk, and days rehospitalized', 'KCCQ-CS score', 'Insufficient calorie intake', 'Block Food Frequency Questionnaire (FFQ), and the Nutritional Risk Index (NRI', 'readmission risk stratification']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0695731,"At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio [OR] 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio [IRR]: 31.3; 95% CI: 4.3 to 229.3).
","[{'ForeName': 'Feriha', 'Initials': 'F', 'LastName': 'Bilgen', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Armella', 'Initials': 'A', 'LastName': 'Poggi', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Trumble', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Helmke', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Teruya', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Tonimarie', 'Initials': 'T', 'LastName': 'Catalan', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Rosenblum', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Cornellier', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Wahida', 'Initials': 'W', 'LastName': 'Karmally', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan; Columbia University, New York, New York. Electronic address: scothumm@med.umich.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.004']
2433,32653446,Sex Differences in Patients Receiving Left Ventricular Assist Devices for End-Stage Heart Failure.,"OBJECTIVES


This study sought to use INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) results to evaluate sex differences in the use and clinical outcomes of left ventricular assist devices (LVAD).
BACKGROUND


Despite a similar incidence of heart failure in men and women, prior studies have highlighted potential underuse of LVADs in women, and studies of clinical outcomes have yielded conflicting results.
METHODS


Patients were enrolled from the INTERMACS study who underwent implantation of their first continuous-flow LVAD between 2008 and 2017, and survival analyses stratified by sex were conducted.
RESULTS


Among the 18,868 patients, 3,984 (21.1%) were women. At 1 year, women were less likely to undergo heart transplantation than men (17.9% vs. 20.0%, respectively; p = 0.003). After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p < 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction. Although women younger than 50 years of age had an increased risk of death compared to men of the same age (HR: 1.34; 95% CI: 1.12 to 1.6), men and women 65 years of age and older had a similar risk of death (HR: 1.09; 95% CI: 0.95 to 1.24).
CONCLUSIONS


This study found that women had a higher risk of mortality and adverse events after LVAD. Only 1 in 5 LVADs were implanted in women, and women were less likely to receive a heart transplant than men. Further investigation is needed to understand the causes of adverse events and potential underuse of advanced treatment options in women.",2020,"After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p < 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction.","['Patients Receiving Left Ventricular Assist Devices for End-Stage Heart\xa0Failure', 'women', 'Patients were enrolled from the INTERMACS study who underwent implantation of their first continuous-flow LVAD between 2008 and 2017, and survival analyses stratified by sex were conducted', '18,868 patients, 3,984 (21.1%) were women', 'men and women']",[],"['likely to undergo heart transplantation', 'rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction', 'risk of death', 'risk of mortality and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C1868938', 'cui_str': 'End stage cardiac failure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",18868.0,0.331156,"After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p < 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction.","[{'ForeName': 'Jadry', 'Initials': 'J', 'LastName': 'Gruen', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Caraballo', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'P Elliott', 'Initials': 'PE', 'LastName': 'Miller', 'Affiliation': 'Yale National Clinician Scholars Program, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McCullough', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mezzacappa', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Ravindra', 'Affiliation': 'Department of Biophysics and Biochemistry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Clancy W', 'Initials': 'CW', 'LastName': 'Mullan', 'Affiliation': 'Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Samuel W', 'Initials': 'SW', 'LastName': 'Reinhardt', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Arnar', 'Initials': 'A', 'LastName': 'Geirsson', 'Affiliation': 'Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nihar R', 'Initials': 'NR', 'LastName': 'Desai', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: nihar.desai@yale.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.015']
2434,32653447,Effect of Dapagliflozin in Patients With HFrEF Treated With Sacubitril/Valsartan: The DAPA-HF Trial.,"OBJECTIVES


This study assessed the efficacy and safety of dapagliflozin in patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial.
BACKGROUND


Both the angiotensin receptor neprilysin-inhibitor sacubitril/valsartan and the sodium glucose co-transporter 2 inhibitor dapagliflozin reduced cardiovascular death and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction (HFrEF). Whether either of these classes of drugs influences the effectiveness or safety of the other remains unknown.
METHODS


DAPA-HF was a 4,744 patient trial that compared dapagliflozin with placebo in patients with HFrEF. Patients were analyzed according to whether they were taking sacubitril/valsartan at randomization. The efficacy of dapagliflozin on the primary composite outcome (CV death or episode of worsening heart failure), its components, and all-cause death was examined according to sacubitril/valsartan and the interaction tested. Predefined safety outcomes were examined by sacubitril/valsartan group.
RESULTS


A total of 508 patients (10.7%) enrolled in DAPA-HF were treated with sacubitril/valsartan at baseline. Patients prescribed sacubitril/valsartan were more likely to be from North America or Europe, to have lower ejection fractions and systolic and diastolic blood pressures, but were similar with respect to age, New York Heart Association functional class, history of diabetes, and use of other evidence-based HF therapies. The benefit of dapagliflozin compared with placebo was similar in patients taking sacubitril/valsartan (hazard ratio: 0.75; 95% confidence interval 0.50 to 1.13) compared with those not taking sacubitril/valsartan (hazard ratio: 0.74; 95% confidence interval 0.65 to 0.86) for the primary endpoint of cardiovascular death or worsening HF; similar findings were observed for secondary endpoints. All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
CONCLUSIONS


Dapagliflozin was similarly efficacious and safe in patients who were and who were not taking sacubitril/valsartan in the DAPA-HF trial, which suggested that the use of both agents together could further lower morbidity and mortality in patients with HFrEF. (Dapagliflozin And Prevention of Adverse outcomes in Heart Failure [DAPA-HF]; NCT03036124).",2020,"All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
","['patients with HF with reduced ejection fraction (HFrEF', '508 patients (10.7%) enrolled in DAPA-HF were treated with', 'Patients With HFrEF', 'DAPA-HF was a 4,744 patient trial that compared', 'patients who were and who were not taking sacubitril', 'patients with HFrEF', 'patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of', 'Patients With Chronic Heart Failure) trial']","['dapagliflozin or placebo', 'valsartan', 'dapagliflozin with placebo', 'dapagliflozin', 'background sacubitril/valsartan', 'Dapagliflozin', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'placebo']","['cardiovascular death', 'primary composite outcome (CV death or episode of worsening heart failure), its components, and all-cause death', 'efficacy and safety', 'cardiovascular death and heart failure (HF) hospitalization', 'ejection fractions and systolic and diastolic blood pressures', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",508.0,0.140024,"All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ssolomon@bwh.harvard.edu.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Riggshospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""St. Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Kansas.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University Medical School, New Haven, Connecticut.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Section of Endocrinology, Yale University Medical School, New Haven, Connecticut.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjostrand', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.008']
2435,32653532,Quantitative Assessment of the Efficacy of Two Different Single-file Systems in Reducing the Bacterial load in Oval- Shaped Canals: An In Vivo Study.,"INTRODUCTION


This randomized clinical study compared the in vivo antibacterial efficacy of Reciproc Blue (RB), XP-endo Shaper (XP-S),XP-endo Shaper associated with XP-endo Finisher (XP-F) systems in infected oval-shaped root canals with primary apical periodontitis.
METHODS


In this study, 28 human teeth with a single root and a single canal were randomly assigned to two groups according to the instrumentation technique: group-1, RB (n = 14) and group-2, XP-endo (XP-S and XP-F, n = 14). The single-rooted teeth were prepared by reciprocating and rotary nickel-titanium (NiTi) instruments with 5.25% sodium hypochlorite irrigation. Samples were collected from the canal at the baseline (S1), after chemomechanical preparation (S2), and after XP-F instrumentation (S3). The DNA extracts were subjected to quantitative analysis for total bacterial counts by quantitative real-time polymerase chain reaction. The data were analyzed using the analysis of variance test (ANOVA), and the level of significance was set at 5%.
RESULTS


All samples tested positive for the presence of bacteria at baseline, and the bacterial counts substantially reduced after treatment procedures (P < 0.01). The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P ˃ 0.05). A marked bacterial reduction was observed after the use of the XP-F instrument (P < 0.01).
CONCLUSION


The XP-S and RB systems sharply reduced the bacterial load in oval-shaped root canals with primary apical periodontitis. XP-F, used as a supplementary instrument to chemomechanical preparation, promoted a significantly higher bacterial reduction.",2020,The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P ˃ 0.05).,"['Oval- Shaped Canals', '28 human teeth with a single root and a single canal', 'infected oval-shaped root canals with primary apical periodontitis']","['reciprocating and rotary nickel-titanium (NiTi) instruments with 5.25% sodium hypochlorite irrigation', 'Reciproc Blue (RB), XP-endo Shaper (XP-S),XP-endo Shaper associated with XP-endo Finisher (XP-F) systems']","['bacterial counts', 'bacterial reduction']","[{'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",28.0,0.0301852,The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P ˃ 0.05).,"[{'ForeName': 'Rodrigo Rodrigues', 'Initials': 'RR', 'LastName': 'Amaral', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia; Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. Electronic address: r.amaral@griffith.edu.au.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Braga', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reher', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Anna Gabriella', 'Initials': 'AG', 'LastName': 'Guimarães Oliveira', 'Affiliation': 'Institute of Biological Sciences, Department of Microbiology, Laboratory of Oral Microbiology and Anaerobes, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'de Macêdo Farias', 'Affiliation': 'Institute of Biological Sciences, Department of Microbiology, Laboratory of Oral Microbiology and Anaerobes, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Paula Prazeres', 'Initials': 'PP', 'LastName': 'Magalhães', 'Affiliation': 'Institute of Biological Sciences, Department of Microbiology, Laboratory of Oral Microbiology and Anaerobes, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Pedro Gonçalves', 'Initials': 'PG', 'LastName': 'Ferreira', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ilma de Souza Côrtes', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.007']
2436,32662827,Effectiveness of Brushing Associated with Oral Irrigation in Maintenance of Peri-Implant Tissues and Overdentures: Clinical Parameters and Patient Satisfaction.,"Implant-supported prostheses hygiene and peri-implant tissues health are considered to be predictive factors for successful prosthetic rehabilitation. Therefore, the purpose of this study was to evaluate the effectiveness of brushing associated with oral irrigation measured as biofilm-removing capacity, maintenance of healthy oral tissues, and patient satisfaction. A randomized, crossover clinical trial was conducted with 38 patients who wore conventional maxillary complete dentures and mandibular overdentures retained by the O-ring system. The patients were instructed to use the following hygiene methods for 14 days: mechanical brushing [MB (brush and dentifrice - Control)]; and MB with oral irrigation [WP (Waterpik - Experimental)]. Biofilm-removing capacity and maintenance of healthy oral tissues were evaluated by the Modified Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing Index (BP) recorded at baseline and after each method. In parallel, patients answered a specific questionnaire using a Visual Analogue Scale after each hygiene method. Data were analyzed by Friedman and Wilcoxon tests (α=0.05). The results showed significantly lower PI, GI, PD, and BP indices after application of the hygiene methods (P<0.001) than those observed at baseline. However, no significant difference was found between MB and WP. The satisfaction questionnaire responses to both methods showed high mean values for all questions, with no statistically significant difference found between the answers given after the use of MB and WP (P>0.05). The findings suggest that WP was effective in reducing PI, GI, PD, and BP indices and provided a high level of patient satisfaction.",2020,"Biofilm-removing capacity and maintenance of healthy oral tissues were evaluated by the Modified Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing Index (BP) recorded at baseline and after each method.",['38 patients who wore conventional maxillary complete dentures and mandibular overdentures retained by the O-ring system'],"['mechanical brushing [MB (brush and dentifrice - Control)]; and MB with oral irrigation [WP (Waterpik - Experimental', 'Oral Irrigation']","['Biofilm-removing capacity and maintenance of healthy oral tissues', 'PI, GI, PD, and BP indices', 'Modified Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing Index (BP', 'biofilm-removing capacity, maintenance of healthy oral tissues, and patient satisfaction', 'satisfaction questionnaire responses', 'lower PI, GI, PD, and BP indices']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0399271', 'cui_str': 'Oral irrigation'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",38.0,0.0538534,"Biofilm-removing capacity and maintenance of healthy oral tissues were evaluated by the Modified Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing Index (BP) recorded at baseline and after each method.","[{'ForeName': 'Marcela Moreira', 'Initials': 'MM', 'LastName': 'Salles', 'Affiliation': ''}, {'ForeName': 'Viviane de Cássia', 'Initials': 'VC', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Macedo', 'Affiliation': ''}, {'ForeName': 'Claudia Helena', 'Initials': 'CH', 'LastName': 'Silva-Lovato', 'Affiliation': ''}, {'ForeName': 'Helena de Freitas', 'Initials': 'HF', 'LastName': 'Oliveira Paranhos', 'Affiliation': 'BRAZIL.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00092']
2437,32662833,"Which Chronic Low Back Pain Patients Respond Favorably to Yoga, Physical Therapy, and a Self-care Book? Responder Analyses from a Randomized Controlled Trial.","PURPOSE


To identify baseline characteristics of adults with chronic low back pain (cLBP) that predict response (i.e., a clinically important improvement) and/or modify treatment effect across three nonpharmacologic interventions.
DESIGN


Secondary analysis of a randomized controlled trial.
SETTING


Academic safety net hospital and seven federally qualified community health centers.
SUBJECTS


Adults with cLBP (N = 299).
METHODS


We report patient characteristics that were predictors of response and/or modified treatment effect across three 12-week treatments: yoga, physical therapy [PT], and a self-care book. Using preselected characteristics, we used logistic regression to identify predictors of ""response,"" defined as a ≥30% improvement in the Roland Morris Disability Questionnaire. Then, using ""response"" as our outcome, we identified baseline characteristics that were treatment effect modifiers by testing for statistical interaction (P < 0.05) across two comparisons: 1) yoga-or-PT vs self-care and 2) yoga vs PT.
RESULTS


Overall, 39% (116/299) of participants were responders, with more responders in the yoga-or-PT group (42%) than the self-care (23%) group. There was no difference in proportion responding to yoga (48%) vs PT (37%, odds ratio [OR] = 1.5, 95% confidence interval = 0.88 - 2.6). Predictors of response included having more than a high school education, a higher income, employment, few depressive symptoms, lower perceived stress, few work-related fear avoidance beliefs, high pain self-efficacy, and being a nonsmoker. Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction). When comparing yoga or PT with self-care, a greater proportion were responders among those using pain meds (OR = 5.3), which differed from those not taking pain meds (OR = 0.94) at baseline. We also found greater treatment response among those with lower (OR = 7.0), but not high (OR = 1.3), fear avoidance beliefs around physical activity.
CONCLUSIONS


Our findings revealed important subgroups for whom referral to yoga or PT may improve cLBP outcomes.",2020,Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction).,"['Adults with cLBP (N\u2009=\u2009299', 'adults with chronic low back pain (cLBP', 'Academic safety net hospital and seven federally qualified community health centers']","['yoga-or-PT vs self-care and 2) yoga vs PT', 'yoga, physical therapy [PT']","['pain medication and fear avoidance beliefs related to physical activity', 'cLBP outcomes', 'proportion responding to yoga']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]",,0.10913,Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction).,"[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gerlovin', 'Affiliation': 'Slone Epidemiology Center, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Delitto', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa153']
2438,32662840,Assessment of healing of dental implant surgical site following Low-Level Laser Therapy using Bio-Clinical parameters: An Exploratory Study.,"The purpose of this study was to evaluate whether Low-Level Laser Therapy (LLLT) improves the healing of the implant surgical site with clinical and biochemical parameters.Thirty patients with an edentulous space spanning a single tooth were selected. The patients were randomly allocated to two groups - the control group and the test group. The test group received laser energy at a power of 2J/cm 2 with a total of 4-6J energy over each implant. Clinical parameters (Implant Stability Quotient, probing index, modified sulcus bleeding index)and osteoprotegerin (OPG) were assessed at baseline and follow-up intervals (2 weeks, 6 weeks, and 3 months).The test group showed significantly higher implant stability quotient compared to thecontrol group at 2 weeks(57.93±3.95 and 35.67±3.08; p<0.01) and 3months(58.86±3.75 and 67.06±3.78; p<0.01). A significant rise in OPG levels of the test group(686.30±125.36pg/ml at baseline and 784.25±108.30pg/ml at 3months;p<0.01) was seen contrary to significant decline in the control group (839.50±249.08pg/ml at baseline,415.30±78.39pg/ml at 3months;p<0.01). Within the limitations of the study, the study suggests that the healing of peri-implant hard and soft tissues may be enhanced with the use of LLLT as an explicit modality during the post-operative period.",2020,"Clinical parameters (Implant Stability Quotient, probing index, modified sulcus bleeding index)and osteoprotegerin (OPG) were assessed at baseline and follow-up intervals (2 weeks, 6 weeks, and 3 months).The test group showed significantly higher implant stability quotient compared to thecontrol group at 2 weeks(57.93±3.95 and 35.67±3.08; p<0.01) and 3months(58.86±3.75 and 67.06±3.78; p<0.01).",['Thirty patients with an edentulous space spanning a single tooth were selected'],"['Low-Level Laser Therapy', 'LLLT', 'Low-Level Laser Therapy (LLLT', 'laser energy at a power of 2J/cm 2 with a total of 4-6J energy over each implant']","['implant stability quotient', 'OPG levels', 'Clinical parameters (Implant Stability Quotient, probing index, modified sulcus bleeding index)and osteoprotegerin (OPG']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0034579', 'cui_str': 'Orthopantogram'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}]",,0.0331076,"Clinical parameters (Implant Stability Quotient, probing index, modified sulcus bleeding index)and osteoprotegerin (OPG) were assessed at baseline and follow-up intervals (2 weeks, 6 weeks, and 3 months).The test group showed significantly higher implant stability quotient compared to thecontrol group at 2 weeks(57.93±3.95 and 35.67±3.08; p<0.01) and 3months(58.86±3.75 and 67.06±3.78; p<0.01).","[{'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Palled', 'Affiliation': ""KLE Society's Institute of Dental Sciences Lecturer Prosthodontics, Crown and Bridge JNMC Campus, Belagavi INDIA Belagavi Karnataka 590010 +91 7080040201 Lecturer,Department of Prosthodontics, KLE VK Institute of Dental Sciences, Belagavi.""}, {'ForeName': 'Dr Jitendra', 'Initials': 'DJ', 'LastName': 'Rao', 'Affiliation': ""Professor,Department of Prosthodontics,Faculty of Dental Sciences, King George's Medical UniversityLucknow.""}, {'ForeName': 'Dr Raghuwar Dayal', 'Initials': 'DRD', 'LastName': 'Singh', 'Affiliation': ""Professor Jr Grade, Department of Prosthodontics, Faculty of Dental Sciences,King George's Medical UniversityLucknow.""}, {'ForeName': 'Dr Shuchi', 'Initials': 'DS', 'LastName': 'Tripathi', 'Affiliation': ""Associate Professor, Depatment of Prosthodontics, Faculty of Dental Sciences,King George's Medical UniversityLucknow.""}, {'ForeName': 'Dr Kalpana', 'Initials': 'DK', 'LastName': 'Singh', 'Affiliation': ""Associate Professor,Department of BiochemistryKing George's Medical UniversityLucknow.""}, {'ForeName': 'Dr Rakesh', 'Initials': 'DR', 'LastName': 'Yadav', 'Affiliation': ""Professor Jr. Grade, Department of Conservative Dentistry and Endodontics,Faculty of Dental Sciences,King George's Medical UniversityLucknow.""}, {'ForeName': 'Dr Umesh', 'Initials': 'DU', 'LastName': 'Verma', 'Affiliation': ""Professor Jr Grade, Department of Periodontics,Faculty of Dental Sciences,King George's Medical UniversityLucknow.""}, {'ForeName': 'Dr Pooran', 'Initials': 'DP', 'LastName': 'Chand', 'Affiliation': ""Department of Prosthodontics,Faculty of Dental Sciences,King George's Medical University,Lucknow.""}]",The Journal of oral implantology,['10.1563/aaid-joi-D-18-00316']
2439,31993916,Do the unlabeled response categories of the Minnesota Living with Heart Failure Questionnaire satisfy the monotonicity assumption of simple-summated scoring?,"PURPOSE


Half of the 21-item Minnesota Living with Heart Failure Questionnaire (MLHFQ) response categories are labeled (0 = No, 1 = Very little, 5 = Very much) and half are not (2, 3, and 4). We hypothesized that the unlabeled response options would not be more likely to be chosen at some place along the scale continuum than other response options and, therefore, not satisfy the monotonicity assumption of simple-summated scoring.
METHODS


We performed exploratory and confirmatory factor analyses of the MLHFQ items in a sample of 1437 adults in the Better Effectiveness After Transition-Heart Failure study. We evaluated the unlabeled response options using item characteristic curves from item response theory-graded response models for MLHFQ physical and emotional health scales. Then, we examined the impact of collapsing response options on correlations of scale scores with other variables.
RESULTS


The sample was 46% female; 71% aged 65 or older; 11% Hispanic, 22% Black, 54% White, and 12% other. The unlabeled response options were rarely chosen. The standard approach to scoring and scores obtained by collapsing adjacent response categories yielded similar associations with other variables, indicating that the existing response options are problematic.
CONCLUSIONS


The unlabeled MLHFQ response options do not meet the assumptions of simple-summated scoring. Further assessment of the performance of the unlabeled response options and evaluation of alternative scoring approaches is recommended. Adding labels for response options in future administrations of the MLHFQ should be considered.",2020,We performed exploratory and confirmatory factor analyses of the MLHFQ items in a sample of 1437 adults in the Better Effectiveness,"['1437 adults in the Better Effectiveness', 'The sample was 46% female; 71% aged 65 or older; 11% Hispanic, 22% Black, 54% White, and 12% other']",[],"['21-item Minnesota Living with Heart Failure Questionnaire (MLHFQ) response categories', 'MLHFQ physical and emotional health scales']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1437.0,0.0219234,We performed exploratory and confirmatory factor analyses of the MLHFQ items in a sample of 1437 adults in the Better Effectiveness,"[{'ForeName': 'Visith', 'Initials': 'V', 'LastName': 'Uy', 'Affiliation': 'Division of General Internal Medicine & Health Services Research, UCLA Department of Medicine, 1100 Glendon Avenue, Suite 850, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Ron D', 'Initials': 'RD', 'LastName': 'Hays', 'Affiliation': 'Division of General Internal Medicine & Health Services Research, UCLA Department of Medicine, 1100 Glendon Avenue, Suite 850, Los Angeles, CA, 90024, USA. drhays@ucla.edu.'}, {'ForeName': 'Jay J', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': 'UCLA Department of Biostatistics, 650 Charles E. Young Drive South, 51-254 CHS, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Fayers', 'Affiliation': 'Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Auerbach', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, University of California, San Francisco, 533 Parnassus Avenue, Room 131, San Francisco, CA, 94117, USA.'}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': 'Department of Orthopaedics, Cedars-Sinai Medical Center, Los Angeles, 116 N. Robertson Blvd., Suite 800, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'Lorraine S', 'Initials': 'LS', 'LastName': 'Evangelista', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California, Irvine, 284 Berk Hall, Irvine, CA, 92697, USA.'}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Ganiats', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive #0725, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Romano', 'Affiliation': 'Department of Internal Medicine, University of California, Davis, 4860 Y Street, Suites 0101 & 0400, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'Division of General Internal Medicine & Health Services Research, UCLA Department of Medicine, 1100 Glendon Avenue, Suite 850, Los Angeles, CA, 90024, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02422-8']
2440,29877749,Restoring physical function after knee replacement: a cross sectional comparison of progressive strengthening vs standard physical therapy.,"Objective : The purpose of this study is to compare the functional status of patients 12 months after total knee arthroplasty (TKA) who underwent progressive strengthening or standard of care rehabilitation to older adults without knee joint pain.  Methods : This cross-sectional design study included 165 participants in the progressive strengthening group, 40 participants in the standard of care group, and 88 older adults (control group). The Knee Outcome Survey - Activity of Daily Living, knee active range of motion (ROM), quadriceps strength, and performance tests were compared between groups using a one-way ANOVA. The proportions of participants in both TKA groups who achieved the lower bound of the 95% confidence interval of the control group were compared using a Fisher's exact test.  Results : Significant between-group effects were found for all variables ( p  < 0.001). The control group had better outcomes than both the progressive strengthening and standard of care groups ( p  < 0.001). Compared to the standard of care group, a higher proportion of participants in the progressive strengthening group achieved the lower bound cutoff for active knee extension ROM ( p  = 0.042), quadriceps strength ( p  = 0.032), and stair climbing time ( p  = 0.029).  Conclusion : More participants in the progressive strengthening group had physical function that was similar to the healthy control group, when compared to the standard of care group. Progressive strengthening rehabilitation may be more effective in restoring normative levels of function after TKA than standard of care.",2020,The control group had better outcomes than both the progressive strengthening and standard of care groups ( p  < 0.001).,"['165 participants in the progressive strengthening group, 40 participants in the standard of care group, and 88 older adults (control group', 'older adults without knee joint pain', 'patients 12\xa0months after total knee arthroplasty (TKA) who underwent']","['progressive strengthening vs standard physical therapy', 'Progressive strengthening rehabilitation', 'progressive strengthening or standard of care rehabilitation']","['quadriceps strength', 'physical function', 'stair climbing time', 'Knee Outcome Survey - Activity of Daily Living, knee active range of motion (ROM), quadriceps strength, and performance tests', 'lower bound cutoff for active knee extension ROM']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",165.0,0.0642573,The control group had better outcomes than both the progressive strengthening and standard of care groups ( p  < 0.001).,"[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pozzi', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'White', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Snyder-Mackler', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Jospeh A', 'Initials': 'JA', 'LastName': 'Zeni', 'Affiliation': 'Department of Physical Therapy, Rutgers University, Newark, NJ, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1479475']
2441,30025617,Long-term safety and efficacy of mirabegron and solifenacin in combination compared with monotherapy in patients with overactive bladder: SYNERGY II study.,,2019,,['patients with overactive bladder'],"['mirabegron and solifenacin', 'monotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}]",[],,0.0186246,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alcántara Montero', 'Affiliation': 'Centro de Salud José María Álvarez, Don Benito, Badajoz, España. Electronic address: a.alcantara.montero@hotmail.com.'}]",Actas urologicas espanolas,['10.1016/j.acuro.2018.06.002']
2442,32661447,Enhancing Social Connectedness in Anxiety and Depression Through Amplification of Positivity: Preliminary Treatment Outcomes and Process of Change.,"Background


Anxiety and depressive disorders are often characterized by perceived social disconnection, yet evidence-based treatments produce only modest improvements in this domain. The well-established link between positive affect (PA) and social connectedness suggests that directly targeting PA in treatment may be valuable.
Method


A secondary analysis of a waitlist-controlled trial (N=29) was conducted to evaluate treatment response and process of change in social connectedness within a 10-session positive activity intervention protocol-Amplification of Positivity (AMP)-designed to increase PA in individuals seeking treatment for anxiety or depression (ClinicalTrials.gov Identifier: NCT02330627). Perceived social connectedness and PA/negative affect (NA) were assessed throughout treatment. Time-lagged multilevel mediation models examined the process of change in affect and connectedness throughout treatment.
Results


The AMP group displayed significantly larger improvements in social connectedness from pre- to post-treatment compared to waitlist; improvements were maintained through 6-month follow-up. Within the AMP group, increases in PA and decreases in NA both uniquely predicted subsequent increases in connectedness throughout treatment. However, experiencing heightened NA throughout treatment attenuated the effect of changes in PA on connectedness. Improvements in connectedness predicted subsequent increases in PA, but not changes in NA.
Conclusions


These preliminary findings suggest that positive activity interventions may be valuable for enhancing social connectedness in individuals with clinically impairing anxiety or depression, possibly through both increasing positive emotions and decreasing negative emotions.",2020,The AMP group displayed significantly larger improvements in social connectedness from pre- to post-treatment compared to waitlist; improvements were maintained through 6-month follow-up.,[],['positive activity interventions'],"['social connectedness', 'Perceived social connectedness and PA/negative affect ', 'PA']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",29.0,0.0168976,The AMP group displayed significantly larger improvements in social connectedness from pre- to post-treatment compared to waitlist; improvements were maintained through 6-month follow-up.,"[{'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Taylor', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Pearlstein', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Sanskruti', 'Initials': 'S', 'LastName': 'Kakaria', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Lyubomirsky', 'Affiliation': 'University of California, Riverside.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'University of California, San Diego.'}]",Cognitive therapy and research,['10.1007/s10608-020-10102-7']
2443,32661497,An Early Test-and-Treat Strategy for Severe Acute Respiratory Syndrome Coronavirus 2.,"As coronavirus disease 2019 cases and deaths continue to expand globally, there is an urgent need to develop, test, and approve effective antiviral therapies. Currently, a majority of clinical trials are evaluating therapies in patients who are already hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) infection. Given that the median time between development of symptoms and need for hospitalization is 1 week, a golden opportunity to intervene early is being missed. Indeed, for many other viral infections, early treatment soon after development of symptoms is associated with decreased mortality, lower hospitalization rates, and lower likelihood of transmission to others. In this study, we advocate for randomized, double-blind, placebo controlled, clinical trials to evaluate promising agents early during SARS CoV-2 infection.",2020,"Indeed, for many other viral infections, early treatment soon after development of symptoms is associated with decreased mortality, lower hospitalization rates, and lower likelihood of transmission to others.",['patients who are already hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) infection'],['placebo'],"['mortality, lower hospitalization rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.191539,"Indeed, for many other viral infections, early treatment soon after development of symptoms is associated with decreased mortality, lower hospitalization rates, and lower likelihood of transmission to others.","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Schiffer', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Johnston', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa232']
2444,32661505,A cluster randomized controlled trial of two task-shifting depression care models on depression alleviation and antidepressant response among HIV clients in Uganda.,"Background


depression is common among people living with HIV, but rarely diagnosed and treated in sub-Saharan Africa, in part due to the paucity of mental health professionals. Task-shifting approaches have been used to address this barrier. We compared the effects of two task-shifting models of depression care on depression alleviation and antidepressant response.
Methods


we conducted a cluster randomized controlled trial of two task-shifting models to facilitating depression care delivered by trained medical providers, one that utilized a structured protocol (protocolized) and one that relied on the judgment of trained providers (clinical acumen), in 10 HIV clinics in Uganda. A sample of 1252 clients (640 at protocolized clinics, 612 at clinical acumen clinics) who had screened positive for potential depression on the 2-item Patient Health Questionnaire (PHQ-2) were enrolled and followed for 12 months. Interviewer-administered 9-item PHQ (PHQ-9) data from the research surveys, and provider administrations to clients treated with antidepressant therapy, were examined. Linear probability regression analyses were conducted using a wild cluster bootstrap to control for clustering.
Results


among the whole sample (regardless of treatment status), rates of depression alleviation (PHQ-9<5) at month 12 were equivalent in the protocolized (75%) and clinical acumen (77%) arms, in an intention-to-treat analysis. Similarly, among the 415 participants who received antidepressant care, rates of treatment response (PHQ-9<5) at the last provider administered PHQ-9 (average of 8 months into treatment) were equivalent between the protocolized (65%) and clinical acumen (69%) arms; rate of improvement over the course of treatment was also equivalent.
Conclusions


nurses can provide quality depression care to HIV clients, regardless of whether treatment is guided by a structured protocol or clinical acumen, in the context of appropriate training and ongoing supervision support.",2016,"Results


among the whole sample (regardless of treatment status), rates of depression alleviation (PHQ-9<5) at month 12 were equivalent in the protocolized (75%) and clinical acumen (77%) arms, in an intention-to-treat analysis.","['1252 clients (640 at protocolized clinics, 612 at clinical acumen clinics) who had screened positive for potential depression on the 2-item Patient Health Questionnaire (PHQ-2) were enrolled and followed for 12 months', '10 HIV clinics in Uganda', 'HIV clients in Uganda', '415 participants who received antidepressant care']","['task-shifting models to facilitating depression care delivered by trained medical providers, one that utilized a structured protocol (protocolized) and one that relied on the judgment of trained providers (clinical acumen', 'task-shifting depression care models', 'two task-shifting models of depression care']","['rates of depression alleviation (PHQ-9<5', 'rates of treatment response (PHQ-9<5', 'depression alleviation and antidepressant response']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2706101', 'cui_str': 'PHQ-2'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]",1252.0,0.0585964,"Results


among the whole sample (regardless of treatment status), rates of depression alleviation (PHQ-9<5) at month 12 were equivalent in the protocolized (75%) and clinical acumen (77%) arms, in an intention-to-treat analysis.","[{'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Wagner', 'Affiliation': 'Department of Health, RAND, Santa Monica, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ghosh-Dastidar', 'Affiliation': 'Department of Health, RAND, Santa Monica, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ngo', 'Affiliation': 'Department of Health, RAND, Santa Monica, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Health, RAND, Santa Monica, USA.'}, {'ForeName': 'Seggane', 'Initials': 'S', 'LastName': 'Musisi', 'Affiliation': 'Department of Health, RAND, Santa Monica, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Glick', 'Affiliation': 'Department of Health, RAND, Santa Monica, USA.'}, {'ForeName': 'Akena', 'Initials': 'A', 'LastName': 'Dickens', 'Affiliation': 'Department of Health, RAND, Santa Monica, USA.'}]",Research and advances in psychiatry,[]
2445,32661756,Comparison of effect of preoperative dienogest and gonadotropin-releasing hormone agonist administration on laparoscopic cystectomy for ovarian endometriomas.,"PURPOSE


To compare the effects of preoperative dienogest (DNG) and gonadotropin-releasing hormone (GnRH) agonist administration on the improvement of preoperative symptoms and surgical outcomes in patients who underwent laparoscopic cystectomy for ovarian endometriomas.
METHODS


Seventy patients who were scheduled for laparoscopic surgery were enrolled in the study. They were divided into two groups: 35 patients who received DNG for 4 months preoperatively (group D) and 35 patients who received low-dose sustained-release goserelin acetate for 4 months preoperatively (group G). Preoperative outcomes, including pain score associated with endometriosis, using the numerical rating scale (NRS), adverse events of hormonal therapy and Kupperman index (KI) before and after treatment, surgical outcomes including total surgical duration and blood loss, and postoperative recurrence of endometrioma were compared between the two groups.
RESULTS


Regarding preoperative symptoms, NRS and KI at 4 months after preoperative hormonal therapy were significantly lower in group D than in group G (NRS, 5.3 ± 5.5 vs. 2.7 ± 3.9; P = 0.01; KI, 16.0 ± 11.0 vs. 9.2 ± 7.6; P = 0.006). Regarding adverse events, the incidence of hot flashes was significantly lower in group D than in group G (P < 0.001). Meanwhile, the incidence of breast pain and metrorrhagia was significantly higher in group D than in group G (P = 0.04 and P < 0.001, respectively). The total surgical duration and blood loss were not significantly different between the groups. At 12 months after surgery, ovarian endometrioma did not recur in either group.
CONCLUSION


Preoperative administration of DNG is more valuable for patients with endometriosis and scheduled for laparoscopic surgery to improve symptoms with good efficacy and tolerability than the administration of GnRH agonist.",2020,The total surgical duration and blood loss were not significantly different between the groups.,"['laparoscopic cystectomy for ovarian endometriomas', 'Seventy patients who were scheduled for laparoscopic surgery were enrolled in the study', 'patients with endometriosis and scheduled for laparoscopic surgery', 'patients who underwent laparoscopic cystectomy for ovarian endometriomas']","['preoperative dienogest and gonadotropin-releasing hormone agonist administration', 'DNG', 'preoperative dienogest (DNG) and gonadotropin-releasing hormone (GnRH) agonist administration', 'low-dose sustained-release goserelin acetate']","['pain score associated with endometriosis, using the numerical rating scale (NRS), adverse events of hormonal therapy and Kupperman index (KI) before and after treatment, surgical outcomes including total surgical duration and blood loss, and postoperative recurrence of endometrioma', 'incidence of hot flashes', 'ovarian endometrioma', 'preoperative symptoms and surgical outcomes', 'incidence of breast pain and metrorrhagia', 'total surgical duration and blood loss']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0700476', 'cui_str': 'Goserelin acetate'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0025874', 'cui_str': 'Intermenstrual bleeding - irregular'}]",70.0,0.033396,The total surgical duration and blood loss were not significantly different between the groups.,"[{'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Ozaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kumakiri', 'Affiliation': ""Department of Obstetrics and Gynecology, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjyuku-ku, Tokyo, 162-8666, Japan. junkumakiri@gmail.com.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Jinushi', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ikuma', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Murakami', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Kitade', 'Affiliation': 'Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05691-3']
2446,32661776,"Feasibility of postural lung recruitment maneuver in children: a randomized, controlled study.","BACKGROUND


Pulmonary atelectasis in anesthetized children is easily reverted by lung recruitment maneuvers. However, the high airways pressure reached during the maneuver could negatively affect hemodynamics. The aim of this study is to assess the effect and feasibility of a postural lung recruitment maneuver (P-RM); i.e., a new maneuver that opens up the atelectatic lung areas based on changing the child's body position under constant ventilation with moderated driving pressure (12 cmH 2 O) and of positive end-expiratory pressure (PEEP, 10 cmH 2 O). Forty ASA I-II children, aged 6 months to 7 years, subjected to general anesthesia were studied. Patients were ventilated with volume control mode using standard settings with 5 cmH 2 O of PEEP. They were randomized into two groups: (1) control group (C group, n = 20)-ventilation was turned to pressure control ventilation using a fixed driving pressure of 12 cmH 2 O. PEEP was increased from 5 to 10 cmH 2 O during 3 min maintaining the supine position. (2) P-RM group (n = 20)-patients received the same increase in driving pressure and PEEP, but they were placed, respectively, in the left lateral position, in the right lateral position (90 s each), and back again into the supine position after 3 min. Then, ventilation returned to baseline settings in volume control mode. Lung ultrasound-derived aeration score and respiratory compliance were assessed before (T1) and after (T2) 10 cmH 2 O of PEEP was applied.
RESULTS


At baseline ventilation (T1), both groups showed similar aeration score (P-RM group 9.9 ± 1.9 vs C group 10.4 ± 1.9; p = 0.463) and respiratory compliance (P-RM group 15 ± 6 vs C group 14 ± 6 mL/cmH 2 O; p = 0.517). At T2, the aeration score decreased in the P-RM group (1.5 ± 1.6 vs 9.9 ± 2.1; p < 0.001), but remained without changes in the C group (9.9 ± 2.1; p = 0.221). Compliance was higher in the P-RM group (18 ± 6 mL/cmH 2 O) when compared with the C group (14 ± 5 mL/cmH 2 O; p = 0.001).
CONCLUSION


Lung aeration and compliance improved only in the group in which a posture change strategy was applied.",2020,Compliance was higher in the P-RM group (18 ± 6 mL/cmH,"['Patients were ventilated with volume control mode using standard settings with 5 cmH 2 O of PEEP', 'anesthetized children', 'Forty ASA I-II children, aged 6\xa0months to 7\xa0years, subjected to general anesthesia were studied', 'children']","['postural lung recruitment maneuver (P-RM', 'postural lung recruitment maneuver', 'control group (C group, n\u2009=\u200920)-ventilation was turned to pressure control ventilation using a fixed driving pressure of 12\xa0cmH 2 O. PEEP']","['Compliance', 'driving pressure and PEEP', 'aeration score', 'Lung ultrasound-derived aeration score and respiratory compliance', 'respiratory compliance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}]",40.0,0.042133,Compliance was higher in the P-RM group (18 ± 6 mL/cmH,"[{'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Acosta', 'Affiliation': 'Department of Anesthesiology, Hospital Privado de Comunidad, Córdoba 4545, 7600, Mar del Plata, Buenos Aires, Argentina.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Volpicelli', 'Affiliation': 'Department of Emergency Medicine, San Luigi Gonzaga University Hospital, Orbassano, Torino, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rudzik', 'Affiliation': 'Department of Anesthesiology, Hospital Privado de Comunidad, Córdoba 4545, 7600, Mar del Plata, Buenos Aires, Argentina.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Venturin', 'Affiliation': 'Department of Anesthesiology, Hospital Privado de Comunidad, Córdoba 4545, 7600, Mar del Plata, Buenos Aires, Argentina.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Gerez', 'Affiliation': 'Department of Anesthesiology, Hospital Privado de Comunidad, Córdoba 4545, 7600, Mar del Plata, Buenos Aires, Argentina.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Ricci', 'Affiliation': 'Department of Mathematics, Facultad de Ciencias Exactas, Universidad Nacional de Mar del Plata, Mar del Plata, Argentina.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Natal', 'Affiliation': 'Department of Mathematics, Facultad de Ciencias Exactas, Universidad Nacional de Mar del Plata, Mar del Plata, Argentina.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Tusman', 'Affiliation': 'Department of Anesthesiology, Hospital Privado de Comunidad, Córdoba 4545, 7600, Mar del Plata, Buenos Aires, Argentina. gtusman@hotmail.com.'}]",The ultrasound journal,['10.1186/s13089-020-00181-8']
2447,32661909,"Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women.","BACKGROUND AND OBJECTIVES


Advanced estrogen receptor-positive (ER+) breast cancer is currently treated with endocrine therapy. Elacestrant is a novel, nonsteroidal, selective estrogen receptor degrader with complex dose-related ER agonist/antagonist activity that is being developed as a treatment option for ER+ breast cancer.
METHODS


Two first-in-human phase 1 studies of elacestrant in healthy postmenopausal women (Study 001/Study 004) were conducted to determine its pharmacokinetic and pharmacodynamic profile as well as its safety and maximum tolerated dose.
RESULTS


In total, 140 postmenopausal subjects received at least one dose of study drug (114 received elacestrant and 26 received placebo). Single-ascending dose and multiple-ascending dose assessments showed that doses up to 1000 mg daily were safe and well tolerated, and the maximum tolerated dose was not reached. Oral administration of elacestrant had an absolute bioavailability of 10% and a mean half-life ranging from 27 to 47 h, reaching steady state after 5-6 days. Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily. The median ratio of elacestrant concentrations in the cerebral spinal fluid vs. plasma was 0.126% (500 mg dose) and 0.205% (200 mg dose). Most adverse events were related to the upper gastrointestinal tract.
CONCLUSIONS


These data demonstrate that elacestrant has good bioavailability when administered orally with a half-life that supports once-daily administration. Engagement of the ER and some ability to cross the blood-brain barrier was demonstrated in addition to an acceptable safety profile.",2020,Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily.,"['Two first-in-human phase 1 studies of elacestrant in healthy postmenopausal women (Study 001/Study 004', 'Healthy Post-Menopausal Women', '140 postmenopausal subjects received at least one dose of study drug (114 received elacestrant and 26 received']",['placebo'],"['absolute bioavailability', 'median ratio of elacestrant concentrations', 'Mean occupancy of the ER', 'safe and well tolerated']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}, {'cui': 'C4682404', 'cui_str': 'elacestrant'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4682404', 'cui_str': 'elacestrant'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",4.0,0.0994447,Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily.,"[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Conlan', 'Affiliation': 'Department of Oncology Clinical Development, Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA. mconlan@radiuspharm.com.'}, {'ForeName': 'Erik F J', 'Initials': 'EFJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Awjm', 'Initials': 'A', 'LastName': 'Glaudemans', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Radius Health, Inc., 950 Winter Street, Waltham, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Troy', 'Affiliation': 'Department of Clinical Pharmacology, Radius Health, Inc., 950 Winter Street, Waltham, MA, USA.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00635-3']
2448,32662054,Development and Feasibility of MindChip™: A Social Emotional Telehealth Intervention for Autistic Adults.,"The study aims to develop and pilot a telehealth social emotional program, MindChip™ delivered with a computer based interventions (CBI) (Mind Reading © ) for autistic adults. MindChip™ combined four theoretical perspectives and community feedback underpinning the essential mechanisms for targeting the social emotional understanding of autistic adults. A randomised pragmatic pilot trial (N = 25) was conducted to explore the feasibility of MindChip™ (n = 11) and to understand the preliminary efficacy of combining it with CBI compared to CBI only (n = 14). The use of MindChip™ and CBI combined demonstrated partial feasibility, with preliminary efficacy findings revealing increased emotion recognition generalisation outcomes compared to CBI only. Further research is required to improve the engagement and personalisation of the intervention for autistic adults.",2020,"The use of MindChip™ and CBI combined demonstrated partial feasibility, with preliminary efficacy findings revealing increased emotion recognition generalisation outcomes compared to CBI only.","['autistic adults', 'Autistic Adults']","['MindChip', 'Social Emotional Telehealth Intervention', 'MindChip™', 'telehealth social emotional program, MindChip™ delivered with a computer based interventions (CBI) (Mind Reading © ']",['emotion recognition generalisation outcomes'],"[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0287648,"The use of MindChip™ and CBI combined demonstrated partial feasibility, with preliminary efficacy findings revealing increased emotion recognition generalisation outcomes compared to CBI only.","[{'ForeName': 'Julia S Y', 'Initials': 'JSY', 'LastName': 'Tang', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia. julia.tang@postgrad.curtin.edu.au.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Falkmer', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Nigel T M', 'Initials': 'NTM', 'LastName': 'Chen', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bӧlte', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Girdler', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04592-3']
2449,32662069,Qigong for the treatment of depressive symptoms: Preliminary evidence of neurobiological mechanisms.,"OBJECTIVES


Qigong has been shown to effectively reduce depressive symptoms in older adults with chronic physical illness. Here we sought to evaluate the effects of qigong on serotonin, cortisol, and BDNF levels, and test their roles as potential mediators of the effects of qigong on depressive symptoms.
METHODS


Thirty older adults with chronic physical illness participated in a randomized clinical trial. They were randomly assigned to a qigong group (n = 14) or a control group for cognitive training of executive function and memory (n = 16). The participants provided blood and saliva samples at baseline and post-intervention. Levels of cortisol were measured from the salvia samples, and serotonin and Brain-derived Neurotropic Factors (BDNF) were measured from the blood samples.
RESULTS


Consistent with the study findings presented in the primary outcome paper, a significant Group × Time interaction effect emerged on depressive symptoms, explained by greater reductions in the qigong group than the control group. Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants. Moreover, treatment-related changes in cortisol levels (but not serotonin or BDNF) fully mediated the beneficial effects of qigong on depressive symptoms.
CONCLUSION


The findings provide preliminary evidence that treatment-related changes in cortisol may mediate the benefits of qigong on depressive symptoms. Given the limitation of small sample size of the present study, future studies with larger sample sizes and more extended follow-up assessment are warranted to determine the reliability of these findings. This article is protected by copyright. All rights reserved.",2020,"Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants.","['older adults with chronic physical illness', 'Thirty older adults with chronic physical illness', 'depressive symptoms']","['Qigong', 'qigong group (n\xa0=\xa014) or a control group for cognitive training of executive function and memory']","['Levels of cortisol', 'cortisol levels', 'serotonin, cortisol, and BDNF levels', 'serotonin and Brain-derived Neurotropic Factors (BDNF', 'serotonin and BDNF', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",30.0,0.0837699,"Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants.","[{'ForeName': 'Erin Yiqing', 'Initials': 'EY', 'LastName': 'Lu', 'Affiliation': 'Neuropsychiatric Rehabilitation Laboratory, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Posen', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Department of Occupational Therapy, I-Shou University, Kaohsiung City, Taiwan.'}, {'ForeName': 'Shuhe', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopedic Rehabilitation, Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Wendy Wing Yan', 'Initials': 'WWY', 'LastName': 'So', 'Affiliation': 'Neuropsychiatric Rehabilitation Laboratory, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Bacon Fung Leung', 'Initials': 'BFL', 'LastName': 'Ng', 'Affiliation': 'Department of Chinese Medicine, Hospital Authority, Hong Kong SAR.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Wai Ming', 'Initials': 'WM', 'LastName': 'Cheung', 'Affiliation': 'Faculty of Education, The University of Hong Kong, Pokfulam Road, Hong Kong SAR.'}, {'ForeName': 'Hector W H', 'Initials': 'HWH', 'LastName': 'Tsang', 'Affiliation': 'Neuropsychiatric Rehabilitation Laboratory, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}]",International journal of geriatric psychiatry,['10.1002/gps.5380']
2450,32662092,Effect of dipeptidyl peptidase-4 inhibitors on complement activation.,"AIMS


Adverse activation of the complement cascade in the innate immune system appears to be involved in development of vascular complications in diabetes. Dipeptidyl peptidase-4 (DPP-4) is a cell surface serine protease expressed in a variety of tissues. DPP-4 inhibitors are widely used in treatment of type 2 diabetes and appear to yield beneficial pleiotropic effects beyond their glucose-lowering action, e.g. renoprotective and anti-inflammatory properties, but the exact mechanisms remain unknown. We hypothesized that DPP-4 inhibitors block adverse complement activation by inhibiting complement-activating serine proteases.
MATERIALS AND METHODS


We analyzed the effects of 7 different DPP-4 inhibitors on the lectin and classical pathway of the complement system in vitro by quantifying complement factor C4b deposition onto mannan or IgG coated surfaces, respectively. Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n=34) or placebo (n=37) for 12 weeks.
RESULTS


All the 7 DPP-4 inhibitors tested in the study directly inhibited functional activity of the lectin pathway in a dose-dependent manner with varying potency in vitro. In vivo, MBL, sMAC, and C4b declined significantly during follow-up in both groups without significant effect of sitagliptin.
CONCLUSIONS


We demonstrated an inhibitory effect of DPP-4 inhibitors on the lectin pathway in vitro. The clinical relevance of this effect of DPP-4 inhibitors remains to be fully elucidated. This article is protected by copyright. All rights reserved.",2020,"Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n=34) or placebo (n=37) for 12 weeks.
","['diabetes', '71 patients with a recent acute coronary syndrome and glucose disturbances']","['DPP-4 inhibitors', 'Dipeptidyl peptidase-4 (DPP-4', 'placebo', 'dipeptidyl peptidase-4 inhibitors']","['Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition', 'MBL, sMAC, and C4b']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}]",71.0,0.0519561,"Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n=34) or placebo (n=37) for 12 weeks.
","[{'ForeName': 'Ingeborg T', 'Initials': 'IT', 'LastName': 'Hoffmann-Petersen', 'Affiliation': 'Department of Internal Medicine, Regional Hospital of Northern Jutland, Hjørring, Denmark.'}, {'ForeName': 'Charlotte B', 'Initials': 'CB', 'LastName': 'Holt', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Jensen', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hage', 'Affiliation': 'Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Linda G', 'Initials': 'LG', 'LastName': 'Mellbin', 'Affiliation': 'Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Troels K', 'Initials': 'TK', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jakob A', 'Initials': 'JA', 'LastName': 'Østergaard', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3385']
2451,32654663,Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study.,"BACKGROUND


In patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively.
METHODS


In the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias.
RESULTS


Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants.
CONCLUSIONS


While both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI.
TRIAL REGISTRATION


Clinical Trials.gov NCT02905539. Registered on 8 September 2016. 2015-004808-36 (EudraCT Number) U1111-1176-4563 (WHO Universal Trial Number) DRKS00010766 (Deutsches Register Klinischer Studien).",2020,"RESULTS


Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001).","['participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI', 'U1111-1176-4563 ', '2015-004808-36 (EudraCT Number', '26 women with iron deficiency anemia (hemoglobin <\u200912\u2009g/dL plus either plasma ferritin ≤\u2009100\u2009ng/mL or a plasma ferritin ≤\u2009300\u2009ng/mL and transferrin saturation (TSAT)\u2009≤\u200930', 'patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion']","['FCM', 'single intravenous infusion of 20\u2009mg/kg body weight (up to a maximum of 1000\u2009mg) FCM or FDI', 'ferric carboxymaltose', 'FCM and FDI']","['plasma intact FGF23', 'incidence of hypophosphatemia (plasma phosphorus levels', 'Hypophosphatemia', 'lower plasma 1.25-dihydroxyvitamin D', 'skeletal and cardiovascular markers', 'mineral and bone metabolism, left ventricular function, and arrhythmias', 'urinary phosphorus losses, urinary fractional phosphorus excretion']","[{'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0560741', 'cui_str': 'mg/kg body weight'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0012328', 'cui_str': 'Dihydroxyvitamins D'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1977907', 'cui_str': 'Fractional excretion of phosphate'}]",26.0,0.501746,"RESULTS


Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001).","[{'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Emrich', 'Affiliation': 'Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany. insa.emrich@uks.eu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lizzi', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Siegel', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seiler-Mussler', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ukena', 'Affiliation': 'Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaddu-Mulindwa', 'Affiliation': 'Internal Medicine I-Hematology and Oncology, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""D'Amelio"", 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wagenpfeil', 'Affiliation': 'Institute for Medical Biometry, Epidemiology and Medical Informatics, University Medical Center, Saarland University, Campus Homburg, Homburg, Germany.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Brandenburg', 'Affiliation': 'Department of Cardiology and Nephrology, Rhein-Maas Klinikum, Würselen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fliser', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Heine', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany. gunnar.heine@uks.eu.'}]",BMC medicine,['10.1186/s12916-020-01643-5']
2452,32654677,The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial.,"OBJECTIVE


We examined associations of urine iodide excretion, proxy for iodine intake, with child development and growth.
DESIGN


This is a secondary analysis of a 1:1 cluster-randomised trial with a 6-month nutrition/stimulation/hygiene education intervention among mothers of children aged 6-8 months to improve child development and growth. Development was assessed using Bayley Scales of Infant and Toddler Development-III (BSID-III) and Ages and Stages Questionnaire (ASQ), whereas anthropometry was used to assess growth. Urine iodide concentration (UIC) and urine iodide/creatinine ratio (ICR) were measured.
SETTING


The current study was conducted in southern Uganda.
PARTICIPANTS


We randomly selected 155 children from the 511 enrolled into the original trial and analysed data when they were aged 20-24 and 36 months.
RESULTS


Median UIC for both study groups at 20-24 and 36 months were similar (P > 0·05) and within the normal range of 100-199 µg/l (0·79-1·60 µmol/l), whereas the intervention group had significantly higher ICR at 20-24 months. The BSID-III cognitive score was positively associated (P = 0·028) with ICR at 20-24 months in the intervention group. The ASQ gross motor score was negatively associated (P = 0·020) with ICR at 20-24 months among the controls. ICR was not significantly associated with anthropometry in the two study groups at either time-point.
CONCLUSIONS


Following the intervention, a positive association was noted between ICR and child's cognitive score at 20-24 months, whereas no positive association with ICR and growth was detected. Iodine sufficiency may be important for child's cognitive development in this setting.",2020,"RESULTS


Median UIC for both study groups at 20-24 and 36 months were similar (P > 0·05) and within the normal range of 100-199 µg/l (0·79-1·60 µmol/l), whereas the intervention group had significantly higher ICR at 20-24 months.","['children in rural Uganda', 'mothers of children aged 6-8 months to improve child development and growth', 'southern Uganda', 'We randomly selected 155 children from the 511 enrolled into the original trial and analysed data when they were aged 20-24 and 36 months']",['nutrition/stimulation/hygiene education intervention'],"['Bayley Scales of Infant and Toddler Development-III (BSID-III) and Ages and Stages Questionnaire (ASQ', ""ICR and child's cognitive score"", 'BSID-III cognitive score', 'Urine iodide concentration (UIC) and urine iodide/creatinine ratio (ICR', 'ICR', 'ASQ gross motor score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1720477', 'cui_str': 'When'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0204945', 'cui_str': 'Hygiene education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439806', 'cui_str': 'Gross'}]",155.0,0.0418781,"RESULTS


Median UIC for both study groups at 20-24 and 36 months were similar (P > 0·05) and within the normal range of 100-199 µg/l (0·79-1·60 µmol/l), whereas the intervention group had significantly higher ICR at 20-24 months.","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Atukunda', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Grace Km', 'Initials': 'GK', 'LastName': 'Muhoozi', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, 0317Oslo, Norway.'}, {'ForeName': 'Lien M', 'Initials': 'LM', 'LastName': 'Diep', 'Affiliation': 'Oslo Center for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Berg', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ane C', 'Initials': 'AC', 'LastName': 'Westerberg', 'Affiliation': 'Institute of Health Sciences, Kristiania University College, Oslo, Norway.'}, {'ForeName': 'Per O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, 0317Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980020001603']
2453,32654802,Atezolizumab plus Bevacizumab Versus Sunitinib for Patients with Untreated Metastatic Renal Cell Carcinoma and Sarcomatoid Features: A Prespecified Subgroup Analysis of the IMmotion151 Clinical Trial.,"Patients with metastatic renal cell carcinoma with sarcomatoid features (sRCC) have a poor prognosis and have shown limited responsiveness to inhibition of the VEGF pathway. We conducted a prespecified analysis of the randomised, phase 3 IMmotion151 trial in previously untreated patients with advanced or metastatic RCC to assess the effectiveness of atezolizumab + bevacizumab versus sunitinib in a subgroup of patients with sarcomatoid features. Patients whose tumour had any component of sarcomatoid features were included and received atezolizumab + bevacizumab (n = 68) or sunitinib (n = 74). Baseline characteristics were similar between the groups. Median progression-free survival was significantly longer in the group receiving atezolizumab + bevacizumab overall (8.3 vs 5.3 mo; hazard ratio [HR] 0.52 95% confidence interval [CI] 0.34-0.79) and in the subset of patients with PD-L1-positive tumours (8.6 vs 5.6 mo; HR 0.45, 95% CI 0.26-0.77). More patients receiving atezolizumab + bevacizumab achieved an objective response (49% vs 14%), including complete responses (10% vs 3%), and reported greater symptom improvements versus sunitinib. Safety was consistent with the known profiles of each drug and with that reported in the overall safety-evaluable population of IMmotion151. This analysis supports enhanced activity of atezolizumab + bevacizumab in patients with sRCC. PATIENT SUMMARY: In this report, we looked at patients with a specific type of kidney cancer (tumours with sarcomatoid features) that has been hard to treat. A treatment with two drugs (atezolizumab and bevacizumab) appeared to help patients live longer without the disease getting worse than another drug (sunitinib) that is often used. Patients who took the two drugs also said they were better able to carry out their everyday activities than patients who took sunitinib. The combination of these two drugs may work better in patients with this type of advanced kidney cancer.",2020,"More patients receiving atezolizumab + bevacizumab achieved an objective response (49% vs 14%), including complete responses (10% vs 3%), and reported greater symptom improvements versus sunitinib.","['patients with a specific type of kidney cancer (tumours with sarcomatoid features', 'patients with sRCC', 'Patients with Untreated Metastatic Renal Cell Carcinoma and Sarcomatoid Features', 'in a subgroup of patients with sarcomatoid features', 'Patients with metastatic renal cell carcinoma with sarcomatoid features (sRCC', 'previously untreated patients with advanced or metastatic RCC', 'patients with this type of advanced kidney cancer', 'Patients whose tumour had any component of sarcomatoid features']","['sunitinib', 'two drugs (atezolizumab and bevacizumab', 'Atezolizumab plus Bevacizumab Versus Sunitinib', 'atezolizumab\u2009+\u2009bevacizumab versus sunitinib', 'atezolizumab\u2009+\u2009bevacizumab']","['objective response', 'complete responses', 'everyday activities', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.23841,"More patients receiving atezolizumab + bevacizumab achieved an objective response (49% vs 14%), including complete responses (10% vs 3%), and reported greater symptom improvements versus sunitinib.","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: brian.rini@vumc.org.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute and the Royal Free Hospital, Queen Mary University of London, London, UK.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawkins', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'IRCCS San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'CHU Hopitaux de Bordeaux - Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': 'Ashford Cancer Centre Research, Kurralta Park, SA, Australia.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Mahrukh', 'Initials': 'M', 'LastName': 'Huseni', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Susheela', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Sufan', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}]",European urology,['10.1016/j.eururo.2020.06.021']
2454,32654806,Comparison of the Hemodynamic and Temperature Effects of a 500-mL Bolus of 4% Albumin at Room Versus Body Temperature in Cardiac Surgery Patients.,"OBJECTIVE


To compare the hemodynamic effect of room temperature (cold) 4% albumin fluid bolus therapy (FBT) with body temperature (warm) albumin FBT.
DESIGN


Prospective, before-after trial.
SETTING


A tertiary intensive care unit (ICU).
PARTICIPANTS


Sixty ventilated, post-cardiac surgery patients prescribed with 4% albumin FBT.
INTERVENTION


Cold or warm 4% albumin 500 ml FBT.
MEASUREMENTS AND MAIN RESULTS


We recorded hemodynamic parameters before and for 30 minutes after FBT. Cardiac index (CI) and mean arterial pressure (MAP) responses were defined by a CI increase >15% and a MAP increase >10%, respectively. Immediately after FBT, median [interquartile range] core temperature changed by -0.3 [-0.4; -0.3] °C with cold albumin vs. 0.0 [0.0; 0.1]°C with warm albumin (P<0.001). The median CI increase was 0.3 [0.0; 0.5] L/min/m2 with 14 CI-responders (47%) in both groups (P>0.99). The median immediate MAP increase was 9 [3; 15] mmHg with cold albumin vs. 11 [5; 13] mmHg with warm albumin (P=0.79), with a MAP-response in 16 vs. 17 patients (P=0.99). There was an interaction between group and time for MAP (P=0.002), mean pulmonary artery pressure (PAP) (P=0.002) and core temperature (P<0.001). In the cold albumin group, after the initial response, MAP and mean PAP decreased more slowly than with warm albumin and, after the initial fall, core temperature increased toward baseline.
CONCLUSION


In postoperative cardiac surgery patients, warm albumin FBT prevents the decrease in core temperature and, after an initial similar increase, is associated with a faster return of MAP and mean PAP toward baseline.",2020,"There was an interaction between group and time for MAP (P=0.002), mean pulmonary artery pressure (PAP) (P=0.002) and core temperature (P<0.001).","['A tertiary intensive care unit (ICU', 'Sixty ventilated, post-cardiac surgery patients prescribed with 4% albumin FBT', 'Cardiac Surgery Patients']","['Cold or warm 4% albumin 500 ml FBT', 'room temperature (cold) 4% albumin fluid bolus therapy (FBT) with body temperature (warm) albumin FBT', '500-mL Bolus of 4% Albumin']","['Cardiac index (CI) and mean arterial pressure (MAP) responses', 'initial response, MAP and mean PAP', 'median CI increase', 'mean pulmonary artery pressure (PAP', 'median immediate MAP increase']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0520869', 'cui_str': 'Increased cardiac index'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0520853', 'cui_str': 'Increased mean arterial pressure'}]",,0.133007,"There was an interaction between group and time for MAP (P=0.002), mean pulmonary artery pressure (PAP) (P=0.002) and core temperature (P<0.001).","[{'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia; Service de médecine intensive et réanimation, hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lucchetta', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thummaporn', 'Initials': 'T', 'LastName': 'Naorungroj', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia; Department of Intensive Care, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Salvatore L', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': ""Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia; Dipartimento di Scienze dell'emergenza, anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.""}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Osawa', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Canet', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Centre for Integrated Critical Care, School of Medicine, University of Melbourne, Parkville, Victoria, Australia. Electronic address: rinaldo.bellomo@austin.org.au.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.06.045']
2455,32654836,Social Media Message Designs to Educate Adolescents About E-Cigarettes.,"PURPOSE


E-cigarette use is increasing among adolescents, despite potential harms. Social media messages are a promising way to educate youth about e-cigarettes, yet little is known about what message topics and formats will have beneficial impacts for message reception, reach, e-cigarette knowledge, and beliefs about harms.
METHODS


A national convenience sample of adolescents (n = 928, aged 15-18 years) in high school was recruited for an online experiment. In October 2019, participants were randomized to view one of three social media formats (visual based, quiz, and text only) or a no-message control. Participants in format conditions viewed six unique topics in a random order. Outcomes were e-cigarette knowledge and beliefs. Message reactions and sharing preferences were also assessed among youth who saw social media messages.
RESULTS


Social media messages led to greater knowledge (Cohen's f = .19; p < .001) and beliefs (f = .16; p < .001) about harms of e-cigarettes compared with the control, regardless of format. Almost four in five adolescents (79%) reported they would share the social media messages, most likely in person (49%) and with friends (52%). Message topics for missing out because of lung damage, having uncontrolled moods, and ingesting specific harmful chemicals elicited higher intended message reactions.
CONCLUSIONS


Social media messages can educate about e-cigarette harms. Social media campaigns are a promising e-cigarette education strategy to reach youth, directly and potentially through peer-to-peer sharing.",2020,"RESULTS


Social media messages led to greater knowledge (Cohen's f = .19; p < .001) and beliefs (f = .16; p < .001) about harms of e-cigarettes compared with the control, regardless of format.","['A national convenience sample of adolescents (n\xa0= 928, aged 15-18 years) in high school was recruited for an online experiment']","['Social Media Message Designs', 'social media formats (visual based, quiz, and text only) or a no-message control']",['e-cigarette knowledge and beliefs'],"[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",,0.0461007,"RESULTS


Social media messages led to greater knowledge (Cohen's f = .19; p < .001) and beliefs (f = .16; p < .001) about harms of e-cigarettes compared with the control, regardless of format.","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: lazard@unc.edu.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.05.030']
2456,32654884,Decreased neural inhibitory state in fibromyalgia pain: A cross-sectional study.,"OBJECTIVES


Chronic pain is one of the most common and challenging symptoms in fibromyalgia (FM). Currently, self-reported pain is the main criterion used by clinicians assessing patients with pain. However, it is subjective, and multiple factors can affect pain levels. In this study, we investigated the neural correlates of FM pain using conditioned pain modulation (CPM), electroencephalography (EEG), and transcranial magnetic stimulation (TMS).
METHODS


In this cross-sectional neurophysiological analysis of a randomized, double-blind controlled trial, 36 patients with fibromyalgia were included. We analyzed CPM, EEG variables and TMS measures and their correlation with pain levels as measured by a visual analog scale. Univariate and multivariate linear regression analyses were performed to identify the predictors of pain severity.
RESULTS


We found: (1) no association between pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels; (3) an association between smaller event-related desynchronization (ERD) responses in theta and delta bands over the central region and higher pain levels; (4) an association between smaller ERD responses in theta and delta bands and smaller intracortical inhibition and higher intracortical facilitation ratios; (5) an association between smaller ERD responses in delta band and reduced CPM.
CONCLUSIONS


Our results do not support CPM as a biomarker for pain intensity in FM. However, our specific EEG findings showing the relationship between pain, CPM and TMS measures suggest that FM leads to a disruption of inhibitory neural modulators and thus support CPM as a likely predictive marker of disrupted pain modulation system. These neurophysiological markers need to be further explored in potential future trials as to find novel targets for the treatment of FM.",2020,"We found: (1) no association between pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels; (3) an association between smaller event-related desynchronization (ERD) responses in theta and delta bands over the central region and higher pain levels; (4) an association between smaller ERD responses in theta and delta bands and smaller intracortical inhibition and higher intracortical facilitation ratios; (5) an association between smaller ERD responses in delta band and reduced CPM.
","['36 patients with fibromyalgia were included', 'patients with pain', 'fibromyalgia pain']","['conditioned pain modulation (CPM), electroencephalography (EEG), and transcranial magnetic stimulation (TMS']","['neural inhibitory state', 'pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels', 'pain intensity', 'CPM, EEG variables and TMS measures and their correlation with pain levels', 'pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0454907', 'cui_str': 'Central region'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332287', 'cui_str': 'With'}]",36.0,0.123009,"We found: (1) no association between pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels; (3) an association between smaller event-related desynchronization (ERD) responses in theta and delta bands over the central region and higher pain levels; (4) an association between smaller ERD responses in theta and delta bands and smaller intracortical inhibition and higher intracortical facilitation ratios; (5) an association between smaller ERD responses in delta band and reduced CPM.
","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur-Kucukseymen', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Castelo-Branco', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.'}, {'ForeName': 'Maria Alejandra', 'Initials': 'MA', 'LastName': 'Luna-Cuadros', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Cardenas-Rojas', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Giannoni-Luza', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA; Department of Endocrinology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Anna Carolyna', 'Initials': 'AC', 'LastName': 'Gianlorenco', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA; Department of Physical Therapy, Federal University of Sao Carlos, Brazil.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Gnoatto-Medeiros', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Emad Salman', 'Initials': 'ES', 'LastName': 'Shaikh', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA. Electronic address: Fregni.Felipe@mgh.harvard.edu.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2020.06.002']
2457,32654902,Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series.,"BACKGROUND


Concomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) vaccines in infants.
METHODS


In a phase 3, open-label study, 284 healthy infants from 11 UK centres received DTaP5-HB-IPV-Hib at age 2, 3, and 4 months; 13-valent pneumococcal conjugate vaccine (PCV13) at 2 and 4 months; a Haemophilus influenzae type b (Hib)-MCC vaccine and a measles/mumps/rubella vaccine at 12 months. Participants were randomised 1:1 to receive either an MCC-detoxified tetanus toxin vaccine (MCC-TT; n = 141) or an MCC-Corynebacterium diphtheriae CRM 197  protein vaccine (MCC-CRM; n = 143) at 3 and 4 months. The primary outcome was seroprotection rate (SPR) to MCC (percent with rabbit complement serum bactericidal antibody titer ≥8).
RESULTS


Per protocol analysis, MCC SPRs were 100 and 96.4 one month after the first dose, 100 and 99.1 after the second dose, and 100 and 97.3 after the third (booster) dose of MCC in the MCC-TT and MCC-CRM groups, respectively. One month after all 3 doses of DTaP5-HB-IPV-Hib, immunoglobulin G anti-polyribosylribitol phosphate SPRs (% ≥0.15 µg/mL) were 97.8 in the MCC-TT group and 100 in the MCC-CRM group; anti-hepatitis B antigen SPRs (% ≥10 mIU/mL) were 96.8 and 96.3 in the MCC-TT and MCC-CRM groups, respectively. All participants were seroprotected against diphtheria and tetanus (≥0.01 IU/mL) and poliovirus types 1, 2, and 3 (≥8 dilution), and seroresponse rates to all pertussis antigens were ≥90.4%. Two vaccine-related serious adverse events (transient severe abdominal pain and crying) occurred concomitantly in 1 participant in the MCC-CRM group. Adverse event rates were similar to other studies of DTaP5-HB-IPV-Hib, with pyrexia ≥38 °C in 10.9% of participants following any dose.
CONCLUSIONS


DTaP5-HB-IPV-Hib can be effectively used in a 2-, 3-, and 4-month infant priming schedule when given with 2 doses of MCC.",2020,"All participants were seroprotected against diphtheria and tetanus (≥0.01 IU/mL) and poliovirus types 1, 2, and 3 (≥8 dilution), and seroresponse rates to all pertussis antigens were ≥90.4%.","['284 healthy infants from 11 UK centres received', 'infants']","['DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) vaccines', 'MCC-detoxified tetanus toxin vaccine (MCC-TT; n\xa0=\xa0141) or an MCC-Corynebacterium diphtheriae CRM 197  protein vaccine (MCC-CRM', 'DTaP5-HB-IPV-Hib at age 2, 3, and 4\xa0months; 13-valent pneumococcal conjugate vaccine (PCV13) at 2 and 4\xa0months; a Haemophilus influenzae type b (Hib)-MCC vaccine and a measles/mumps/rubella vaccine', 'DTaP5-HB-IPV-Hib, immunoglobulin G anti-polyribosylribitol phosphate SPRs', 'DTaP5-HB-IPV-Hib vaccine']","['Adverse event rates', 'seroprotection rate (SPR) to MCC (percent with rabbit complement serum bactericidal antibody titer\xa0≥8', 'serious adverse events (transient severe abdominal pain and crying']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0027575', 'cui_str': 'Neisseria meningitidis'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0039617', 'cui_str': 'tetanus toxin'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0010150', 'cui_str': 'Corynebacterium diphtheriae'}, {'cui': 'C0056499', 'cui_str': 'CRM197 (non-toxic variant of diphtheria toxin)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0626314', 'cui_str': 'sperm releasing substance'}, {'cui': 'C0062086', 'cui_str': 'Haemophilus influenzae Type b vaccine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027575', 'cui_str': 'Neisseria meningitidis'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",284.0,0.0936911,"All participants were seroprotected against diphtheria and tetanus (≥0.01 IU/mL) and poliovirus types 1, 2, and 3 (≥8 dilution), and seroresponse rates to all pertussis antigens were ≥90.4%.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Oliver', 'Affiliation': ""Bristol Children's Vaccine Centre, University of Bristol & University Hospitals Bristol NHS Foundation Trust, Bristol, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sadorge', 'Affiliation': 'Sanofi Pasteur MSD, Lyon, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Boisnard', 'Affiliation': 'Sanofi Pasteur MSD, Lyon, France.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, University of Oxford Department of Paediatrics and the NIHR Oxford Biomedical Research Council, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tomlinson', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mann', 'Affiliation': 'Taunton and Somerset NHS Foundation Trust, Somerset, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rudd', 'Affiliation': 'Royal Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Bhakthavalsala', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""St George's, University of London and St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Hughes', 'Affiliation': 'Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Sanofi Pasteur MSD, Lyon, France.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': ""Bristol Children's Vaccine Centre, University of Bristol & University Hospitals Bristol NHS Foundation Trust, Bristol, UK. Electronic address: Adam.Finn@bristol.ac.uk.""}]",Vaccine,['10.1016/j.vaccine.2020.06.015']
2458,32655132,Intranasal oxytocin increases heart-rate variability in men at clinical high risk for psychosis: a proof-of-concept study.,"Autonomic nervous system (ANS) dysfunction (i.e., increased sympathetic and/or decreased parasympathetic activity) has been proposed to contribute to psychosis vulnerability. Yet, we still lack directed therapeutic strategies that improve ANS regulation in psychosis or at-risk states. The oxytocin system constitutes a potential therapeutic target, given its role in ANS regulation. However, whether intranasal oxytocin ameliorates autonomic regulation during emerging psychosis is currently unknown. We pooled together two datasets, one of 30 men at clinical high risk for psychosis (CHR-P), and another of 17 healthy men, who had participated in two double-blinded, placebo-controlled, randomised, crossover MRI studies with similar protocols. All participants self-administered 40 IU of intranasal oxytocin or placebo using a nasal spray. We recorded pulse plethysmography during a period of 8 min at about 1 h post dosing and estimated heart rate (HR) and high-frequency HR variability (HF-HRV), an index of cardio-parasympathetic activity. CHR-P and healthy men did not differ at resting HR or HF-HRV under placebo. We found a significant condition × treatment effect for HF-HRV, showing that intranasal oxytocin, compared with placebo, increased HF-HRV in CHR-P but not in healthy men. The main effects of treatment and condition were not significant. In this proof-of-concept study, we show that intranasal oxytocin increases cardio-parasympathetic activity in CHR-P men, highlighting its therapeutic potential to improve autonomic regulation in this clinical group. Our findings support the need for further research on the preventive and therapeutic potential of intranasal oxytocin during emerging psychosis, where we lack effective treatments.",2020,"We found a significant condition × treatment effect for HF-HRV, showing that intranasal oxytocin, compared with placebo, increased HF-HRV in CHR-P but not in healthy men.","['men at clinical high risk for psychosis', 'CHR-P men', '30 men at clinical high risk for psychosis (CHR-P), and another of 17 healthy men, who had participated in two double-blinded', 'healthy men']","['placebo', 'intranasal oxytocin or placebo', 'intranasal oxytocin', 'Intranasal oxytocin']","['heart-rate variability', 'heart rate (HR) and high-frequency HR variability (HF-HRV), an index of cardio-parasympathetic activity', 'cardio-parasympathetic activity', 'HF-HRV']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.128575,"We found a significant condition × treatment effect for HF-HRV, showing that intranasal oxytocin, compared with placebo, increased HF-HRV in CHR-P but not in healthy men.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martins', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Micheli', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Krawczun-Rygmaczewska', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fusar-Poli', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. yannis.paloyelis@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-020-00890-7']
2459,32655245,A Comparative Study to Assess the Efficacy of Fractional Carbon Dioxide Laser and Combination of Fractional Carbon Dioxide Laser with Topical Autologous Platelet-rich Plasma in Post-acne Atrophic Scars.,"Context


Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit prevalent in adolescent population. Atrophic acne scarring negatively affects the quality of life. Although challenging to treat, the introduction of fractional carbon dioxide (CO 2 ) laser and platelet-rich plasma (PRP) therapy for atrophic scars has opened up new avenues.
Aim


The aim of this study was to evaluate and compare the efficacy of fractional CO 2  laser alone and in combination with topical PRP in treating post-acne atrophic scars.
Subjects and Methods


A hospital-based prospective, double-blinded, randomized, and comparative study was conducted. A total of 33 cases with post-acne atrophic scars of moderate to severe grade were randomly allotted into Group A and Group B who were treated for three monthly sessions of fractional CO 2  laser followed by topical PRP and fractional CO 2  laser monotherapy, respectively. Evaluation at baseline and every visit was carried out and compared at the end of 12 weeks.
Results


Of the 33 patients, 25 completed the study. The mean change in score was higher in subjects of Group A. The mean scar score significantly reduced in both groups. The mean visual analog scale was higher in Group A. The reduction in scar score was significantly higher in patients with rolling scars and boxcar scars and least in ice pick scars. Erythema, edema, pain, and hyperpigmentation were higher in Group B.
Conclusion


Combination therapy with PRP is more efficacious in reducing post-acne atrophic scars and reducing adverse effects of laser therapy as compared to fractional CO 2  laser monotherapy.",2019,The reduction in scar score was significantly higher in patients with rolling scars and boxcar scars and least in ice pick scars.,"['33 patients', '33 cases with post-acne atrophic scars of moderate to severe grade', 'Subjects and Methods\n\n\nA hospital-based prospective', 'Post-acne Atrophic Scars']","['PRP', 'fractional carbon dioxide (CO 2 ) laser and platelet-rich plasma (PRP) therapy', 'fractional CO 2  laser followed by topical PRP and fractional CO 2  laser monotherapy', 'Fractional Carbon Dioxide Laser and Combination of Fractional Carbon Dioxide Laser with Topical Autologous Platelet-rich Plasma', 'fractional CO 2  laser alone and in combination with topical PRP']","['quality of life', 'mean visual analog scale', 'mean scar score', 'scar score', 'Erythema, edema, pain, and hyperpigmentation', 'mean change in score', 'adverse effects', 'Atrophic acne scarring']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0162154', 'cui_str': 'Atrophic scar'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]",33.0,0.0307602,The reduction in scar score was significantly higher in patients with rolling scars and boxcar scars and least in ice pick scars.,"[{'ForeName': 'Nazneen Z', 'Initials': 'NZ', 'LastName': 'Arsiwala', 'Affiliation': 'Department of Dermatology, Shri B. M. Patil Medical College, Hospital and Research Centre, BLDE (Deemed to be University), Bijapur, Karnataka, India.'}, {'ForeName': 'Arun C', 'Initials': 'AC', 'LastName': 'Inamadar', 'Affiliation': 'Department of Dermatology, Shri B. M. Patil Medical College, Hospital and Research Centre, BLDE (Deemed to be University), Bijapur, Karnataka, India.'}, {'ForeName': 'Keshavmurthy A', 'Initials': 'KA', 'LastName': 'Adya', 'Affiliation': 'Department of Dermatology, Shri B. M. Patil Medical College, Hospital and Research Centre, BLDE (Deemed to be University), Bijapur, Karnataka, India.'}]",Journal of cutaneous and aesthetic surgery,['10.4103/JCAS.JCAS_142_19']
2460,32655246,Efficacy of Topical Timolol versus Saline in Chronic Venous Ulcers: A Randomized Controlled Trial.,"Background


Chronic venous ulcers sometimes fail to heal in spite of adequate treatment. Nonhealing is possibly because of chronic activation of β-2 adrenergic receptor (B2-AR) in the keratinocytes by endogenously generated catecholamines, which inhibits keratinocyte migration. Blocking of B2-AR using β-blockers has been reported to promote wound healing through keratinocyte migration, angiogenesis, and fibroblast migration. Topical timolol, a B2-AR antagonist, is used to promote wound healing.
Aims and Objectives


The aim of this study was to compare the efficacy of topical timolol versus saline in chronic venous leg ulcers and to compare the mean reduction in ulcer area at the end of 4 weeks.
Materials and Methods


Twenty patients were randomized into two groups. Patients in Group 1 were treated with one drop of 0.5% topical timolol every alternate days for 4 weeks. Ulcer margins were measured and ulcer area calculated every week for 4 weeks. Similar dressing and measurement were carried out for patients with saline for 4 weeks. Healing rate was assessed by the percentage of reduction of ulcer area of both groups at week 4.
Results


The mean reduction in the ulcer size in timolol group was 86.80%, and in saline group 43.82% at the end of 4 weeks.
Conclusion


Topical timolol is an easy, noninvasive therapy that can be recommended for chronic ulcer.",2019,"The mean reduction in the ulcer size in timolol group was 86.80%, and in saline group 43.82% at the end of 4 weeks.
","['Chronic Venous Ulcers', 'chronic venous leg ulcers']","['topical timolol', 'Topical timolol', 'Topical Timolol versus Saline', 'timolol', 'saline']","['Ulcer margins', 'Healing rate', 'ulcer size']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",20.0,0.0295115,"The mean reduction in the ulcer size in timolol group was 86.80%, and in saline group 43.82% at the end of 4 weeks.
","[{'ForeName': 'Abhay K', 'Initials': 'AK', 'LastName': 'Rai', 'Affiliation': 'Department of Dermatology, PSG Institute of Medical Sciences and Research (PSGIMSR), Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Janani', 'Affiliation': 'Department of Dermatology, PSG Institute of Medical Sciences and Research (PSGIMSR), Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Rai', 'Affiliation': 'Department of Dermatology, PSG Institute of Medical Sciences and Research (PSGIMSR), Coimbatore, Tamil Nadu, India.'}]",Journal of cutaneous and aesthetic surgery,['10.4103/JCAS.JCAS_13_19']
2461,32655356,"Randomized, Double-Blind Assessment of LFP Versus SUA Guidance in STN-DBS Lead Implantation: A Pilot Study.","Background:  The efficacy of deep brain stimulation (DBS) therapy in Parkinson's disease (PD) patients is highly dependent on the precise localization of the target structures such as subthalamic nucleus (STN). Most commonly, microelectrode single unit activity (SUA) recordings are performed to refine the target. This process is heavily experience based and can be technically challenging. Local field potentials (LFPs), representing the activity of a population of neurons, can be obtained from the same microelectrodes used for SUA recordings and allow flexible online processing with less computational complexity due to lower sampling rate requirements. Although LFPs have been shown to contain biomarkers capable of predicting patients' symptoms and differentiating various structures, their use in the localization of the STN in the clinical practice is not prevalent.  Methods:  Here we present, for the first time, a randomized and double-blinded pilot study with intraoperative online LFP processing in which we compare the clinical benefit from SUA- versus LFP-based implantation. Ten PD patients referred for bilateral STN-DBS were randomly implanted using either SUA or LFP guided targeting in each hemisphere. Although both SUA and LFP were recorded for each STN, the electrophysiologist was blinded to one at a time. Three months postoperatively, the patients were evaluated by a neurologist blinded to the intraoperative recordings to assess the performance of each modality. While SUA-based decisions relied on the visual and auditory inspection of the raw traces, LFP-based decisions were given through an online signal processing and machine learning pipeline.  Results:  We found a dramatic agreement between LFP- and SUA-based localization (16/20 STNs) providing adequate clinical improvement (51.8% decrease in 3-month contralateral motor assessment scores), with LFP-guided implantation resulting in greater average improvement in the discordant cases (74.9%,  n  = 3 STNs). The selected tracks were characterized by higher activity in beta (11-32 Hz) and high-frequency (200-400 Hz) bands ( p  < 0.01) of LFPs and stronger non-linear coupling between these bands ( p  < 0.05).  Conclusion:  Our pilot study shows equal or better clinical benefit with LFP-based targeting. Given the robustness of the electrode interface and lower computational cost, more centers can utilize LFP as a strategic feedback modality intraoperatively, in conjunction to the SUA-guided targeting.",2020,Ten PD patients referred for bilateral STN-DBS were randomly implanted using either SUA or LFP guided targeting in each hemisphere.,"[""Parkinson's disease (PD) patients"", 'STN-DBS Lead Implantation', 'Ten PD patients referred for bilateral STN-DBS']","['intraoperative online LFP', 'SUA- versus LFP-based implantation', 'Local field potentials (LFPs', 'deep brain stimulation (DBS) therapy', 'LFP Versus SUA Guidance', 'SUA or LFP']",[],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]",[],,0.117205,Ten PD patients referred for bilateral STN-DBS were randomly implanted using either SUA or LFP guided targeting in each hemisphere.,"[{'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Ozturk', 'Affiliation': 'Department of Biomedical Engineering, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Telkes', 'Affiliation': 'Department of Neuroscience and Experimental Therapeutics, Albany Medical College, Albany, NY, United States.'}, {'ForeName': 'Joohi', 'Initials': 'J', 'LastName': 'Jimenez-Shahed', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Tarakad', 'Affiliation': 'Department of Neurology, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Neurology, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Nuri F', 'Initials': 'NF', 'LastName': 'Ince', 'Affiliation': 'Department of Biomedical Engineering, University of Houston, Houston, TX, United States.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00611']
2462,32655381,Effect of Acute Exercise on Prefrontal Oxygenation and Inhibitory Control Among Male Children With Autism Spectrum Disorder: An Exploratory Study.,"Objective : Children with autism spectrum disorder (ASD) experience significant challenges in executive functioning. Emerging evidence suggests exercise may improve executive functioning among children; however, these effects and their mechanisms have not been fully explored among children with ASD. The purpose of this study was to explore the acute effect of exercise on cerebral oxygenation within the prefrontal cortex and inhibitory control among male children with ASD.  Method : Participants ( N  = 12) were 8-12 years of age with a diagnosis of ASD. A within-subject crossover design was employed. Participants completed three 20-min conditions on separate days: circuit-based workout, treadmill walking, and sedentary control. Pre- and post- each condition participants completed a cancellation task (Leiter-3) as a measure of inhibitory control and cerebral oxygenation was concurrently assessed using functional near-infrared spectroscopy (fNIRS). Heart rate, affect, perceived exertion, motivation, and self-efficacy were measured throughout the experiment as manipulation checks and potential psychological mechanisms. A series of repeated measures ANOVAs were conducted to examine intervention effects.  Results : Results demonstrated medium-to-large interaction effects (time by condition) for cerebral oxygenation (    η   p   2      = 0.237) and inhibitory control (    η   p   2      = 0.118).  Post hoc  analyses revealed that the circuit exercise condition elicited the largest changes in both outcomes. The manipulation checks indicated that the exercises were completed as intended.  Conclusion : These findings suggest that exercise may be a feasible intervention for enhancing executive functioning in children with ASD. More research with larger samples is needed to replicate these findings.",2020,Results demonstrated medium-to-large interaction effects (time by condition) for cerebral oxygenation (    η   p   2      = 0.237) and inhibitory control (    η   p   2      = 0.118).  ,"['children with ASD', 'children', 'Spectrum Disorder', 'Objective : Children with autism spectrum disorder (ASD', 'male children with ASD', 'Male Children With Autism', 'Method : Participants ( N  = 12) were 8-12 years of age with a diagnosis of ASD']","['Pre- and post', 'circuit-based workout, treadmill walking, and sedentary control', 'exercise', 'Acute Exercise']","['medium-to-large interaction effects (time by condition) for cerebral oxygenation', 'Heart rate, affect, perceived exertion, motivation, and self-efficacy', 'inhibitory control and cerebral oxygenation', 'executive functioning', 'cerebral oxygenation', 'Prefrontal Oxygenation and Inhibitory Control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",12.0,0.047341,Results demonstrated medium-to-large interaction effects (time by condition) for cerebral oxygenation (    η   p   2      = 0.237) and inhibitory control (    η   p   2      = 0.118).  ,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bremer', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Graham', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Heisz', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cairney', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia, QLD, Australia.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2020.00084']
2463,32655473,A Water-Based Sequential Preparatory Approach vs. Conventional Aquatic Training in Stroke Patients: A Randomized Controlled Trial With a 1-Month Follow-Up.,"Background:  Many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living.  Objective:  The study aim was to compare the effects of a water-based sequential preparatory approach (SPA) and conventional aquatic therapy in improving motor functions and quality of life in patients with chronic stroke.  Methods:  Thirty-three chronic stroke outpatients diagnosed with hemiplegia were recruited and randomly assigned to the experimental or control group. Subjects in the experimental group underwent a trial water-based SPA balance training, and patients in the control group were given traditional water balance training. Both groups of participants underwent 45 min of therapy twice a week for 4 weeks. All patients were evaluated before treatment (T0), after 4 weeks of training (T1), and 4 weeks after the end of training (T2) using the Berg balance scale (BBS), the modified Barthel index (MBI), the Tinetti balance and gait scale (TBG), the Stroke Specific Quality Of Life Scale (SS-QOL), and the modified Ashworth scale (MAS).  Results:  After the training, statistically significant differences ( p  < 0.05) were found between the groups in their score averages on the BBS ( p  = 0.01) and the SS-QOL scale ( p  = 0.03). Furthermore, the SPAg showed a significantly greater percentage of improvement on the BBS ( p  = 0.02) and the SS-QOL ( p  = 0.03). Both groups obtained a significantly improved MAS score ( p  < 0.01).  Conclusion:  Results indicate that water training based on an SPA is more effective than traditional aquatic training for balance rehabilitation of chronic poststroke patients.",2020,"Furthermore, the SPAg showed a significantly greater percentage of improvement on the BBS ( p  = 0.02) and the SS-QOL ( p  = 0.03).","['chronic poststroke patients', 'Methods:  Thirty-three chronic stroke outpatients diagnosed with hemiplegia', 'Stroke Patients', 'patients with chronic stroke']","['traditional water balance training', 'A Water-Based Sequential Preparatory Approach vs. Conventional Aquatic Training', 'water-based sequential preparatory approach (SPA) and conventional aquatic therapy', 'trial water-based SPA balance training', 'traditional aquatic training']","['motor functions and quality of life', 'Berg balance scale (BBS), the modified Barthel index (MBI), the Tinetti balance and gait scale (TBG), the Stroke Specific Quality Of Life Scale (SS-QOL), and the modified Ashworth scale (MAS', 'SS-QOL scale', 'BBS', 'MAS score', 'SS-QOL']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C2732846', 'cui_str': 'Tinetti balance and gait scale'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.023501,"Furthermore, the SPAg showed a significantly greater percentage of improvement on the BBS ( p  = 0.02) and the SS-QOL ( p  = 0.03).","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Temperoni', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Curcio', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Iosa', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Mangiarotti', 'Affiliation': 'ANIK, Associazione Nazionale Idrokinesiterapisti, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Morelli', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'De Angelis', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Vergano', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}]",Frontiers in neurology,['10.3389/fneur.2020.00466']
2464,32655678,New Model for Couple Therapy for Patients with Chronic Pain and their Caregivers: An Attempt to Improve Quality of Life and Reduce Pain.,"Background


Several psychological interventions have been implemented to manage chronic pain. In this study, in addition to the patients, his/her spouses have participated in the program. Besides, this innovative therapy integrates several practical approaches into one comprehensive protocol.
Objective


This study aimed to analyze the effectiveness of couple therapy (patient/caregiver-oriented) on improving the quality of life and reducing pain among patients with chronic pain.
Methods


The present study is a quasi-experimental and clinical trial with a control group with pretest and posttest. The authors conducted this study at LABAFINEJAD Hospital in Tehran on 30 patients with chronic pain and their spouses by having a short form of a questionnaire for quality of life and chronic pain score questionnaire to measure the effectiveness of the treatment.
Results


The results indicated that this treatment increased two aspects of quality of life remarkably, social function and strength for continuing the performance; that help boosts interpersonal relationships as well. Regarding the results, although the couple-based treatment could improve all aspects of pain, the two primary subscales, physical health and mental health, both enhanced. Besides, the treatment reduced the intensity of pain.
Conclusion


Couple-based intervention through increasing social support, improving the quality of sex, decentralizing of pain, and paying attention to the neglected needs of caregivers and patients with chronic pain can improve quality of life and reduce pain in patients.",2020,"Regarding the results, although the couple-based treatment could improve all aspects of pain, the two primary subscales, physical health and mental health, both enhanced.","['LABAFINEJAD Hospital in Tehran on 30 patients with chronic pain and their spouses by having a short form of a questionnaire for', 'patients with chronic pain', 'Patients with Chronic Pain and their Caregivers']",['couple therapy (patient/caregiver-oriented'],"['quality of life and chronic pain score questionnaire', 'quality of life and reduce pain', 'intensity of pain', 'Quality of Life and Reduce Pain', 'quality of life remarkably, social function and strength for continuing the performance', 'quality of life and reducing pain']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0302822', 'cui_str': 'Couple Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",30.0,0.0323471,"Regarding the results, although the couple-based treatment could improve all aspects of pain, the two primary subscales, physical health and mental health, both enhanced.","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Rouhi', 'Affiliation': 'Department of Clinical Psychology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Dadkhah', 'Affiliation': 'Department of Anesthesiology, Fellowship in Pain Management, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Manijeh', 'Initials': 'M', 'LastName': 'Firoozi', 'Affiliation': 'Department of Health Psychology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Hashemi', 'Affiliation': 'Program Director of Pain Fellowship, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Clinical practice and epidemiology in mental health : CP & EMH,['10.2174/1745017902016010053']
2465,32655691,A new oral testosterone undecanoate therapy comes of age for the treatment of hypogonadal men.,"Background


A novel formulation of oral testosterone undecanoate (TU) was studied in a long- and short-term phase III trial to evaluate safety and efficacy.
Methods


Hypogonadal men (age 18-65 years; two morning serum testosterone (T) <300 ng/dl with signs/symptoms) were recruited into a 365 day (trial I) or 105 day (trial II), randomized, multicenter trial. Patients were randomized 1:1 to oral TU ( n  = 161) or T-gel ( n  = 160) in trial I, and 3:1 to oral TU, twice daily (BID) JATENZO® ( n  = 166) or a topical T product [Axiron® ( n  = 56)] in trial II. Dose adjustments were based on average T concentrations ( C avg). Efficacy was assessed based on T levels, body composition and bone density. Safety was assessed by standard clinical measures.
Results


Oral TU efficacy (% of patients with eugonadal T  C avg) was 84% (serum  C avg = 628 ± 343 ng/dl) and 87% (serum T equivalent  C avg ≈ 489 ± 155 ng/dl) in trials I and II, respectively. Oral TU significantly ( p  <0.0001) improved all Psychosexual Daily Questionnaire parameters in trials I and II. In trial I, lean mass increased 3.2 ± 2.7 kg and fat decreased by 2.4 ± 3.6 kg (both  p  <0.0001) and bone density improved in hip (+0.012 ± 0.0225 g/cm 2 ) and spine (+0.018 ± 0.0422 g/cm 2 ) after 365 days (both  p  <0.0001). Oral TU-associated adverse effects were consistent with other T-replacement therapies but oral TU patients experienced a greater number of mild gastrointestinal adverse effects. Oral TU subjects in both studies exhibited an increase in mean systolic blood pressure of about 3-5 mmHg. Oral TU was not associated with liver toxicity nor did it cause an elevation in high-sensitivity C-reactive protein or lipoprotein-associated phospholipase A 2  (cardiovascular safety biomarkers) after 365 days of therapy.
Conclusion


A new oral TU formulation was safe and effective and represents a significant therapeutic advance for the treatment of appropriate hypogonadal men.",2020,Oral TU significantly ( p  <0.0001) improved all Psychosexual Daily Questionnaire parameters in trials I and II.,"['hypogonadal men', 'Methods\n\n\nHypogonadal men (age 18-65\u2009years; two morning serum testosterone (T', 'appropriate hypogonadal men']","['Oral TU', 'oral TU', 'topical T product [Axiron®', 'oral testosterone undecanoate (TU', 'testosterone undecanoate therapy']","['bone density', 'mean systolic blood pressure', 'Safety', 'Psychosexual Daily Questionnaire parameters', 'mild gastrointestinal adverse effects', 'liver toxicity', 'safety and efficacy', 'Efficacy', 'adverse effects', 'T levels, body composition and bone density']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}]","[{'cui': 'C0359087', 'cui_str': 'Testosterone-containing product in oral dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C2961759', 'cui_str': 'Axiron'}, {'cui': 'C0076195', 'cui_str': 'Testosterone undecanoate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.191659,Oral TU significantly ( p  <0.0001) improved all Psychosexual Daily Questionnaire parameters in trials I and II.,"[{'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'David Geffen School of Medicine at UCLA, Division of Endocrinology, Harbor-UCLA Medical Center, The Lundquist Institute at Harbor-UCLA Medical Center, 1124 W. Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Dudley', 'Affiliation': 'Clarus Therapeutics Inc., Northbrook, IL, USA.'}]",Therapeutic advances in urology,['10.1177/1756287220937232']
2466,32655726,Use of Vitamin D With Anti-Tumor Necrosis Factor Therapy for Crohn's Disease.,"Background


Vitamin D (VD) has an important role in regulating gut mucosal immunity, and seems to be inversely linked to disease activity and more frequent relapses in inflammatory bowel disease. In this study, we evaluated patients with Crohn's disease (CD) treated with anti-tumor necrosis factor (TNF) in association with VD.
Methods


A double-blind, randomized, prospective study was conducted. Thirty patients with a history of moderate to severe CD, in use of anti-TNF, of both sexes, 18 to 70 years, with the dosage of VD < 75 nmol/L (30 ng/mL) were randomized and divided into three groups: group 1 (G1): 10 patients received 2,000 IU VD,  per os  (PO)/week for 8 weeks; group 2 (G2): 10 patients received 10,000 IU VD, PO/week for 8 weeks; group 3 (G3): 10 patients received 50,000 IU VD, PO/week for 8 weeks. Before and at the end of 8 weeks patients were submitted to VD, fecal calprotectin (FC) and C-reactive protein (CRP) dosage. Follow-up period was 52 weeks, and they are checked for disease activity recurrence (Crohn's disease activity index (CDAI) > 150, FC > 300 and computerized tomography (CT) scan), FC, CRP, and VD levels.
Results


Increased VD levels were observed in all groups (P < 0.0001). CRP did not change. There was a significant decrease of FC in G3 (1,014 ± 850 vs. 483 ± 564; P = 0.04), no significant decrease in G2 (76,767 ± 751 vs. 535 ± 823; P = 0.2) and increase in G1 (1,101 ± 744 vs. 1,357 ± 819; P = 0.4). During the 52-week follow-up period, it was showed that recurrent disease activity (CDAI > 150, FC > 200 and CT scan) was predominant in patients with VD < 30 group, and the remission rate was predominant in patients with VD > 30 group (P = 0.0001). A statistically significant difference in VD levels was noted in CD patients after 52 weeks that presented flare or disease remission (P = 0.001).
Conclusions


Use of VD associated with anti-TNF treatment may improve clinical response in CD. VD levels greater than 30 ng/mL have better rates of remission.",2020,"There was a significant decrease of FC in G3 (1,014 ± 850 vs. 483 ± 564; P = 0.04), no significant decrease in G2 (76,767 ± 751 vs. 535 ± 823; P = 0.2) and increase in G1 (1,101 ± 744 vs. 1,357 ± 819; P = 0.4).","[""patients with Crohn's disease (CD) treated with anti-tumor necrosis factor (TNF) in association with VD"", 'Thirty patients with a history of moderate to severe CD, in use of anti-TNF, of both sexes, 18 to 70 years, with the dosage of VD < 75 nmol/L (30 ng/mL', ""Crohn's Disease""]","['\n\n\nVitamin D (VD', 'Vitamin D With Anti-Tumor Necrosis Factor Therapy']","['CRP', 'VD levels', 'rates of remission', 'remission rate', 'VD, fecal calprotectin (FC) and C-reactive protein (CRP) dosage', 'FC', ""disease activity recurrence (Crohn's disease activity index (CDAI) > 150, FC > 300 and computerized tomography (CT) scan), FC, CRP, and VD levels"", 'flare or disease remission', 'recurrent disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}]",30.0,0.0176979,"There was a significant decrease of FC in G3 (1,014 ± 850 vs. 483 ± 564; P = 0.04), no significant decrease in G2 (76,767 ± 751 vs. 535 ± 823; P = 0.2) and increase in G1 (1,101 ± 744 vs. 1,357 ± 819; P = 0.4).","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bafutto', 'Affiliation': 'Instituto Goiano de Gastroenterolgoia, Goiania, Brazil.'}, {'ForeName': 'Enio Chaves', 'Initials': 'EC', 'LastName': 'Oliveira', 'Affiliation': 'Instituto Goiano de Gastroenterolgoia, Goiania, Brazil.'}, {'ForeName': 'Joffre', 'Initials': 'J', 'LastName': 'Rezende Filho', 'Affiliation': 'Instituto Goiano de Gastroenterolgoia, Goiania, Brazil.'}]",Gastroenterology research,['10.14740/gr1264']
2467,32662280,Integrating the Early Start Denver Model into Israeli community autism spectrum disorder preschools: Effectiveness and treatment response predictors.,"LAY ABSTRACT


Early intensive intervention has been shown to significantly affect the development of children with Autism. However, the costly implementation of such interventions limits their wide dissemination in the community. This study examined an integration of a research-supported early intensive intervention model called the Early Start Denver Model into community preschool programs for children with Autism in Israel. Four community preschools implemented the preschool-based Early Start Denver Model and four implemented the existing multidisciplinary developmental intervention which is widely applied in Israeli community preschools for children with autism. Fifty-one children (aged 33-57 months) participated in the study. Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools. Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status. Results showed that, compared to the multidisciplinary developmental intervention group, children in the preschool-based Early Start Denver Model treatment group made greater gains on measures of overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities. Children who had lower autism symptom severity, higher adaptive functioning and better language understanding abilities before taking part in the preschool-based Early Start Denver Model program showed greater improvements following it. This study documents the successful implementation of an intensive early intervention program in pre-existing community preschools, underlining the importance of the integration of research-supported intervention programs into community settings.",2020,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","['children with Autism in Israel', 'children with autism', 'children with Autism', 'Fifty-one children (aged 33-57\u2009months) participated in the study', 'Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools']",['intensive early intervention program'],"['overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities', 'adaptive functioning and better language understanding abilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",51.0,0.0150567,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","[{'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Sinai-Gavrilov', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Gev', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Mor-Snir', 'Affiliation': 'The Association for Children at Risk, Israel.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vivanti', 'Affiliation': 'Drexel University, USA.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Golan', 'Affiliation': 'Bar-Ilan University, Israel.'}]",Autism : the international journal of research and practice,['10.1177/1362361320934221']
2468,32662309,The value of a first MRI and targeted biopsies after several years of active surveillance for low-risk prostate cancer - results from the SAMS trial.,"OBJECTIVE


To assess the value of a first MRI examination and image-fusion-guided biopsies in men with low-risk prostate cancer who have been on active surveillance (AS) for several years with no signs of progression.
PATIENTS AND METHODS


All 45 participants from two centers who had not previously had an MRI were included. They had been on AS for T1c Gleason score 6 prostate cancer for 2.6 to 6.7 years and had 2 to 5 sets of systematic biopsies with a total of 1640 cores. All underwent a bi-parametric MRI, PI-RADS ≥ 3 lesions were targeted with image-fusion-guided biopsies. Primary outcome measure: detection of Gleason score ≥7 cancer.
RESULTS


Twenty-five of the 45 men (56%) had a total of 30 suspicious MRI lesions. The lesion with the highest score was a PI-RADS 3 in 18, a PI-RADS 4 in 5 and PI-RADS 5 in 3 men. Targeted biopsies from the 30 lesions detected Gleason score 7 cancer in 6 men. Of these six cancers, four were located in the apical and one in the anterior/apical part of the prostate. A Gleason score 7 cancer was detected in 3 of 5 men with PSA density >0.15 ng/ml/cm 3 .
CONCLUSIONS


Even after several years of AS with stable PSA values and many sets of systematic biopsies, a first MRI and targeted biopsies lead to the detection of Gleason score 7 (ISUP 2 and ISUP 3) cancer in a significant proportion of men, particularly among those with a high PSA density.",2020,"A Gleason score 7 cancer was detected in 3 of 5 men with PSA density >0.15 ng/ml/cm 3 .
","['men with low-risk prostate cancer who have been on active surveillance (AS) for several years with no signs of progression', 'Twenty-five of the 45 men (56%) had a total of 30 suspicious MRI lesions', 'All 45 participants from two centers who had not previously had an MRI were included']",['MRI examination and image-fusion-guided biopsies'],['detection of Gleason score ≥7 cancer'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",5.0,0.079837,"A Gleason score 7 cancer was detected in 3 of 5 men with PSA density >0.15 ng/ml/cm 3 .
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Carlsson', 'Affiliation': 'Urology Department, Karolinska University Hospital, Solna, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Bratt', 'Affiliation': 'Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Dushanka', 'Initials': 'D', 'LastName': 'Kristiansson', 'Affiliation': 'Farsta Urology Clinic, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Jäderling', 'Affiliation': 'Department of Molecular Medicine and Surgery (MMKa), Karolinska Institute, Stockholm, Sweden.'}]",Scandinavian journal of urology,['10.1080/21681805.2020.1788634']
2469,32662323,A randomized controlled trial of a smartphone-based application for the treatment of anxiety.,"Abstract   Introduction:  Generalized anxiety disorder (GAD) is prevalent among college students. Smartphone-based interventions may be a low-cost treatment method.  Method:  College students with self-reported GAD were randomized to receive smartphone-based guided self-help ( n  = 50), or no treatment ( n  = 50). Post-treatment and six-month follow-up outcomes included the Depression Anxiety Stress Scales-Short Form Stress Subscale (DASS Stress), the Penn State Worry Questionnaire (PSWQ-11), and the State-Trait Anxiety Inventory-Trait (STAI-T), as well as diagnostic status assessed by the GAD-Questionnaire, 4th edition.  Results:  From pre- to post-treatment, participants who received guided self-help (vs. no treatment) experienced significantly greater reductions on the DASS Stress ( d  = -0.408) and a greater probability of remission from GAD ( d  = -0.445). There was no significant between-group difference in change on the PSWQ-11 ( d  = -0.208) or STAI-T ( d  = -0.114). From post to six-month follow-up there was no significant loss of gains on DASS Stress scores ( d  = -0.141) and of those who had remitted, 78.6% remained remitted. Yet rates of remitted participants no longer differed significantly between conditions at follow-up ( d  = -0.229).  Conclusion:  Smartphone-based interventions may be efficacious in treating some aspects of GAD. Methods for improving symptom reduction and long-term outcome are discussed.",2020,"From post to six-month follow-up there was no significant loss of gains on DASS Stress scores ( d  = -0.141) and of those who had remitted, 78.6% remained remitted.","['college students', 'Method:  College students with self-reported GAD']","['Smartphone-based interventions', 'smartphone-based guided self-help ( n \u2009=\u200950), or no treatment', 'smartphone-based application']","['probability of remission from GAD', 'DASS Stress scores', 'PSWQ-11', 'Depression Anxiety Stress Scales-Short Form Stress Subscale (DASS Stress), the Penn State Worry Questionnaire (PSWQ-11), and the State-Trait Anxiety Inventory-Trait (STAI-T), as well as diagnostic status assessed by the GAD-Questionnaire, 4th edition', 'DASS Stress']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]",,0.0274946,"From post to six-month follow-up there was no significant loss of gains on DASS Stress scores ( d  = -0.141) and of those who had remitted, 78.6% remained remitted.","[{'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, the Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Department of Psychology, the Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Gavin N', 'Initials': 'GN', 'LastName': 'Rackoff', 'Affiliation': 'Department of Psychology, the Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Megan Jones', 'Initials': 'MJ', 'LastName': 'Bell', 'Affiliation': 'Headspace, Inc., San Francisco, CA, USA.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry, Stanford University, Stanford, CA, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1790688']
2470,32662327,"Do different sit-stand workstations influence lumbar kinematics, lumbar muscle activity and musculoskeletal pain in office workers? A secondary analysis of a randomised controlled trial.","Purpose:  To investigate the effect of different sit-stand workstations on lumbar spine kinematics, lumbar muscle activity and musculoskeletal pain.  Materials and methods:  Thirty-two office workers were randomised to one of three sit-stand workstations (Group 1 , ratio of minutes spent sitting to standing each hour at work was 40:20, n=8; Group 2, 30:30, n=6; Group 3, 20:40, n=7) and a control group (usual sitting, n=11). Intervention groups (Group 1, 2 and 3) were collapsed into one group for analysis (n=21). Data on lumbar kinematics and muscle activity were only collected for 25 participants due to equipment availability.  Results:  Participants in the intervention group had lower overall lumbar spine flexion angles during the workday compared to the control group (mean difference: 10.6°; 95% CI [-18.1, -3.2]; p=0.008; Cohen's d=1.5). There were no between-group differences for the remaining kinematic measures (i.e. mean flexion angle in standing and sitting, mean side flexion angle in standing and sitting, and the percentage of time in upright sitting), muscle activity or the presence of musculoskeletal pain.  Conclusions:  Sit-stand workstations reduced overall lumbar spine flexion angles over the course of a workday but had no effect on other kinematic measures, lumbar spine muscle activity or musculoskeletal pain.  Trial registration:  Australian New Zealand Clinical Trials Registry identifier: ACTRN12615001018505..",2020,"had lower overall lumbar spine flexion angles during the workday compared to the control group (mean difference: 10.6°; 95% CI [-18.1, -3.2]; p=0.008; Cohen's d=1.5).","['Results:  Participants in the intervention group', 'Materials and methods:  Thirty-two office workers', '25 participants due to equipment availability']",['sit-stand workstations'],"['overall lumbar spine flexion angles', 'lumbar kinematics and muscle activity', 'lumbar kinematics, lumbar muscle activity and musculoskeletal pain', 'kinematic measures, lumbar spine muscle activity or musculoskeletal pain', 'lumbar spine kinematics, lumbar muscle activity and musculoskeletal pain', 'remaining kinematic measures (i.e. mean flexion angle in standing and sitting, mean side flexion angle in standing and sitting, and the percentage of time in upright sitting), muscle activity or the presence of musculoskeletal pain']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",25.0,0.081067,"had lower overall lumbar spine flexion angles during the workday compared to the control group (mean difference: 10.6°; 95% CI [-18.1, -3.2]; p=0.008; Cohen's d=1.5).","[{'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Pappas', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Foley', 'Affiliation': 'The School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Zadro', 'Affiliation': 'The School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mackey', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Shirley', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Voukelatos', 'Affiliation': 'Health Promotion Unit, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'The Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2020.1796039']
2471,31175052,Personalized Decision Making in Early Stage Breast Cancer: Applying Clinical Prediction Models for Anthracycline Cardiotoxicity and Breast Cancer Mortality Demonstrates Substantial Heterogeneity of Benefit-Harm Trade-off.,"BACKGROUND


Anthracycline agents can cause cardiotoxicity. We used multivariable risk prediction models to identify a subset of patients with breast cancer at high risk of cardiotoxicity, for whom the harms of anthracycline chemotherapy may balance or exceed the benefits.
PATIENTS AND METHODS


A clinical prediction model for anthracycline cardiotoxicity was created in 967 patients with human epidermal growth factor receptor-negative breast cancer treated with doxorubicin in the ECOG-ACRIN study E5103. Cardiotoxicity was defined as left ventricular ejection fraction (LVEF) decline of ≥ 10% to < 50% and/or a centrally adjudicated clinical heart failure diagnosis. Patient-specific incremental absolute benefit of anthracyclines (compared with non-anthracycline taxane chemotherapy) was estimated using the PREDICT model to assess breast cancer mortality risk.
RESULTS


Of the 967 women who initiated therapy, 51 (5.3%) developed cardiotoxicity (12 with clinical heart failure). In a multivariate model, increasing age (odds ratio [OR], 1.04; 95% confidence interval [CI], 1.01-1.08), higher body mass index (OR, 1.06; 95% CI, 1.02-1.10), and lower baseline LVEF (OR, 0.93; 95% CI, 0.89-0.98) at baseline were significantly associated with cardiotoxicity. The concordance statistic of the risk model was 0.70 (95% CI, 0.63-0.77). In patients with low anticipated treatment benefit (n = 176) from the addition of anthracycline (< 2% absolute risk difference of breast cancer mortality at 10 years), 16 (9%) of 176 had a > 10% risk of cardiotoxicity and 61 (35%) of 176 had a 5% to 10% risk of cardiotoxicity at 1 year.
CONCLUSION


Older age, higher body mass index, and lower baseline LVEF were associated with increased risk of cardiotoxicity. We identified a subgroup with low predicted absolute benefit of anthracyclines but with high predicted risk of cardiotoxicity. Additional studies are needed incorporating long-term cardiac outcomes and cardiotoxicity model external validation prior to implementation in routine clinical practice.",2019,"The concordance statistic of the risk model was 0.70 (95% CI, 0.63-0.77).","['967 women who initiated therapy, 51 (5.3%) developed cardiotoxicity (12 with clinical heart failure', 'Early Stage Breast Cancer', '967 patients with human epidermal growth factor receptor-negative breast cancer treated with', 'patients with breast cancer at high risk of cardiotoxicity, for whom the harms of']","['anthracycline chemotherapy', 'anthracyclines (compared with non-anthracycline taxane chemotherapy', 'doxorubicin', 'anthracycline']","['breast cancer mortality', 'cardiotoxicity', 'Cardiotoxicity', 'left ventricular ejection fraction (LVEF) decline', 'risk of cardiotoxicity', 'higher body mass index']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087185', 'cui_str': 'Human epidermal growth factor receptor negative'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",967.0,0.0610911,"The concordance statistic of the risk model was 0.70 (95% CI, 0.63-0.77).","[{'ForeName': 'Jenica N', 'Initials': 'JN', 'LastName': 'Upshaw', 'Affiliation': 'Division of Cardiology, Tufts Medical Center, Boston, MA; The Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA. Electronic address: jupshaw@tuftsmedicalcenter.org.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ruthazer', 'Affiliation': 'The Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Simon Cancer Center, Indianapolis, IN.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Parsons', 'Affiliation': 'The Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA; Division of Hematology/Oncology, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Erban', 'Affiliation': 'Division of Hematology/Oncology, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': ""O'Neill"", 'Affiliation': 'Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'Biniyam', 'Initials': 'B', 'LastName': 'Demissei', 'Affiliation': 'Division of Cardiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sledge', 'Affiliation': 'Stanford University Medical Center, Palo Alto, CA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Services, Winston-Salem, NC.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'Division of Cardiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'The Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.'}]",Clinical breast cancer,['10.1016/j.clbc.2019.04.012']
2472,32379478,Changes in dietary habits of patients with chronic pain represent contributing factors to decreased pain intensity and improved quality of life. Pilot study from Croatia.,"Introduction


Objectives: to assess the effectiveness of specifically designed nutrition education for the management of chronic pain and whether any change in dietary habits contribute to decrease in pain intensity. Objectives and methods: 40 patients were enrolled in the 4-week interventional observational study. Patients filled-in questionaires regarding their basic characteristics, pain intensity, quality of life, and dietary habits at baseline and post-intervention. Intervention consisted of 1 individual and 2 group counselings based on the nutrition education specifically designed for the chronic pain management. Results: post-intervention, pain intensity decreased in 67.5 % of patients while significantly improving quality of life (from 42.9 ± 31.3 to 70.1 ± 26.2 points, p = 0.015). All patients responded to nutrition education by increasing the number of meals per day (p < 0.001), improving regularity of breakfast (p = 0.005) and by less frequently skipping meals (p = 0.027). Fewer meal skipping (OR = 0.037, 95 % CI (0.003-0.482), p = 0.012) and lower consumption of foods with negative effect on chronic pain (OR = 0.008, 95 % CI (0.000-0.444), p = 0.019) were found to modestly, but independently contribute to decrease in pain intensity. Still, patients with higher BMI and several diagnoses had low resonse. Conclusions: the developed nutrition education is fit for the management of chronic pain. The main benefits are improved meal consumption pattern along with reduced consumption of foods with pro-inflammatory effect and food cravings. The complexity of chronic pain is obvious in low responsiveness among patients with higher BMI and several conditions.",2020,"Fewer meal skipping (OR = 0.037, 95 % CI (0.003-0.482), p = 0.012) and lower consumption of foods with negative effect on chronic pain (OR = 0.008, 95 % CI (0.000-0.444), p = 0.019) were found to modestly, but independently contribute to decrease in pain intensity.","['patients with higher BMI and several conditions', '40 patients were enrolled in the 4-week interventional observational study', 'patients with chronic pain']",['1 individual and 2 group counselings based on the nutrition education specifically designed for the chronic pain management'],"['quality of life', 'consumption of foods with pro-inflammatory effect and food cravings', 'pain intensity', 'pain intensity, quality of life, and dietary habits', 'pain intensity and improved quality of life', 'improving regularity of breakfast', 'lower consumption of foods with negative effect on chronic pain', 'meal skipping']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}]",40.0,0.0704408,"Fewer meal skipping (OR = 0.037, 95 % CI (0.003-0.482), p = 0.012) and lower consumption of foods with negative effect on chronic pain (OR = 0.008, 95 % CI (0.000-0.444), p = 0.019) were found to modestly, but independently contribute to decrease in pain intensity.","[{'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Balkić', 'Affiliation': 'Department for Dietetics and Nutrition. University Hospital Osijek.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Radoš', 'Affiliation': 'Sub-Department of Anesthesiology, Resuscitation and Intensive Care. Faculty of Medicine. University Josip Juraj Strossmayer Osijek.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Banjari', 'Affiliation': 'Faculty of Food Technology. Josip Juraj Strossmayer University of Osijek.'}]",Nutricion hospitalaria,['10.20960/nh.02822']
2473,31277049,Long term follow-up of quality of life and functional ability in patients with ICU acquired Weakness - A post hoc analysis.,"PURPOSE


ICU acquired Weakness (ICUaW) is a common complication of critical illness. The aim of our study was the assessment of quality of life (QoL) and functional ability of patients with ICUaW, 6 months post hospital discharge.
MATERIAL AND METHODS


Eight hundred seventy eight consecutive patients who had been discharged from the ICU were evaluated and 128 of them, 36 with ICUaW, were eligible for the study. Muscle strength was evaluated with MRC and Hand grip dynamometry. The Functional Independence Measure (FIM) was used to evaluate the functional ability while QoL was assessed with the Nottingham Health Profile and with the SF-36 questionnaire.
RESULTS


Patients with ICUaW continued to have low MRC at hospital discharge, [53(49-56) vs. 59(58-60), p < 0.05]. Patients who developed ICUaW had lower Hand grip dynamometry at ICU, hospital discharge and 6 months after (p < 0.05). Patients with ICUaW have significantly lower FIM score at hospital discharge, 3 and 6 months post hospital discharge (p < 0.05) and persistently lower QoL at 3 and 6 months post hospital discharge(p < 0.05).
CONCLUSIONS


ICUaW is associated with persistent deficiencies in functional ability and Qol leading to a prolonged period of recovery. Further research is needed in the field of prevention and targeted rehabilitation of functionality in this patient group.",2019,"Patients who developed ICUaW had lower Hand grip dynamometry at ICU, hospital discharge and 6 months after (p < 0.05).","['patients with ICUaW, 6\u202fmonths post hospital discharge', 'Eight hundred seventy eight consecutive patients who had been discharged from the ICU were evaluated and 128 of them, 36 with ICUaW, were eligible for the study', 'patients with ICU acquired Weakness - A post hoc analysis']",[],"['FIM score at hospital discharge', 'Muscle strength', 'hospital discharge', 'quality of life (QoL) and functional ability', 'lower Hand grip dynamometry at ICU, hospital discharge', 'MRC and Hand grip dynamometry', 'quality of life and functional ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C4274266', 'cui_str': 'Functional Independence Measure score'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",878.0,0.0557851,"Patients who developed ICUaW had lower Hand grip dynamometry at ICU, hospital discharge and 6 months after (p < 0.05).","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Sidiras', 'Affiliation': 'First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Patsaki', 'Affiliation': 'First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Karatzanos', 'Affiliation': 'Clinical Ergospirometry, Exercise and Rehabilitation Laboratory, First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece. Electronic address: lkaratzanos@gmail.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dakoutrou', 'Affiliation': 'Clinical Ergospirometry, Exercise and Rehabilitation Laboratory, First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Kouvarakos', 'Affiliation': 'First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Mitsiou', 'Affiliation': 'Clinical Ergospirometry, Exercise and Rehabilitation Laboratory, First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Routsi', 'Affiliation': 'First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Stranjalis', 'Affiliation': 'Department of Neurosurgery, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Serafim', 'Initials': 'S', 'LastName': 'Nanas', 'Affiliation': 'First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Gerovasili', 'Affiliation': 'First Critical Care Department, Evangelismos Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.'}]",Journal of critical care,['10.1016/j.jcrc.2019.06.022']
2474,31496051,HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI-PMTCT study.,"INTRODUCTION


Published data on viral suppression among pregnant and breastfeeding women in routine care settings are scarce. Here, we report provincial estimates of undetectable and suppressed viral load among pregnant or breastfeeding women in HIV care in Kinshasa, Democratic Republic of Congo (DRC) and associated risk factors.
METHODS


This cross-sectional study was conducted as part of a baseline assessment for the CQI-PMTCT study: an ongoing cluster randomized trial to evaluate the effect of continuous quality interventions (CQI) on long-term ART outcomes among pregnant and breastfeeding women (NCT03048669). From November 2016 to June 2018, in each of the 35 Kinshasa provincial health zones (HZ), study teams visited the three busiest maternal and child health clinics, enrolled all HIV-positive pregnant or breastfeeding women (≤1 year post-delivery) receiving ART, and performed viral load testing. Log binomial models with generalized estimating equations to account for clustering at the HZ level, were used to estimate prevalence ratios comparing participants with undetected (<40 copies/mL) or suppressed (<1000 copies/mL) viral load across levels of individual and site characteristics.
RESULTS


Of the 1752 eligible women, 1623 had viral load results available, including 38% who had been on ART for <6 months and 74% were on tenofovir-lamivudine-efavirenz. Viral load was undetectable in 53% of women and suppressed in 62%. Among women who were on ART for ≥12 months, only 60% and 67% respectively, had undetectable or suppressed viral load. Viral load was undetectable in 53%, 48% and 58% of women testing during pregnancy, at delivery, and in postpartum respectively. In multivariable log binomial models, duration of ART >12 months, older age, being married, disclosure of HIV status, receiving care in an urban health zone or one supported by PEPFAR were all positively associated with viral suppression.
CONCLUSIONS


The observed high level of detectable viral load suggests that high ART coverage alone without substantial efforts to improve the quality of care for pregnant and breastfeeding women, will not be enough to achieve the goal of virtual elimination of vertical HIV transmission in high-burden and limited resources settings like DRC.",2019,Viral load was undetectable in 53% of women and suppressed in 62%.,"['1752 eligible women, 1623 had viral load results available, including 38% who had been on ART for <6\xa0months and 74% were on', 'From November 2016 to June 2018, in each of the 35 Kinshasa provincial health zones (HZ), study teams visited the three busiest maternal and child health clinics, enrolled all HIV-positive pregnant or breastfeeding women (≤1\xa0year post-delivery) receiving ART, and performed viral load testing', 'pregnant and breastfeeding women (NCT03048669', 'participants in CQI-PMTCT study', 'pregnant and breastfeeding women in routine care in the Kinshasa province', 'pregnant or breastfeeding women in HIV care in Kinshasa, Democratic Republic of Congo (DRC) and associated risk factors']","['tenofovir-lamivudine-efavirenz', 'continuous quality interventions (CQI']","['quality of care', 'Viral load', 'HIV viral suppression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",1752.0,0.109004,Viral load was undetectable in 53% of women and suppressed in 62%.,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Yotebieng', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mpody', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Noro Lr', 'Initials': 'NL', 'LastName': 'Ravelomanana', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Tabala', 'Affiliation': 'School of Public Health, The University of Kinshasa, Kinshasa, Democratic Republic of Congo.'}, {'ForeName': 'Fathy', 'Initials': 'F', 'LastName': 'Malongo', 'Affiliation': 'School of Public Health, The University of Kinshasa, Kinshasa, Democratic Republic of Congo.'}, {'ForeName': 'Bienvenu', 'Initials': 'B', 'LastName': 'Kawende', 'Affiliation': 'School of Public Health, The University of Kinshasa, Kinshasa, Democratic Republic of Congo.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ntangu', 'Affiliation': 'National AIDS Control Program (PNLS), Provincial Coordination, Kinshasa, Democratic Republic of Congo.'}, {'ForeName': 'Frieda', 'Initials': 'F', 'LastName': 'Behets', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'Okitolonda', 'Affiliation': 'School of Public Health, The University of Kinshasa, Kinshasa, Democratic Republic of Congo.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25376']
2475,32666477,The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial.,"BACKGROUND


Although bariatric surgery (BS) predisposes patients to development of gallstone formation, a preventive strategy is still in debate.
AIM


To compare the incidence of gallstone formation between patients treated with ursodeoxycholic acid (UDCA) vs. placebo for a duration of 6 months following BS.
METHODS


This multicenter randomized, double-blind controlled trial entails treatment with UDCA vs. an identical-looking placebo. The primary outcome was gallstone formation, as measured by abdominal ultrasound.
RESULTS


The data of 209 subjects were enrolled in the study, and 92 subjects completed the study and were analyzed (n = 46 for each study group). The high dropout rate was mainly due to difficulties in adding more medications and swallowing the pill. Among the subjects who completed the study, 77.2% were women, and their mean age and pre-surgery BMI were 42.2 ± 10.2 years and 44.4 ± 6.1 kg/m 2 , respectively. Gallstone formation was recorded in 45.7% (n = 21) vs. 23.9% (n = 11) of subjects among placebo vs. UDCA groups, respectively, p = 0.029. Subgroup-analysis, according to surgery type, found that the results were significant only for SG subjects (p = 0.041), although the same trend was observed for OAGB/RYGB. Excess Weight Loss percent (%EWL) at 6 months post-surgery was 66.0 ± 17.1% vs. 71.8 ± 19.5% for the placebo and UDCA groups, respectively; p = 0.136. A trend towards a reduction in prescribed comorbidity medications was noted within-groups during the follow-up period, as compared to baseline, with no between-group differences (p ≥ 0.246). Moreover, no between-group differences were found for blood test results (p ≥ 0.063 for all).
CONCLUSION


Administration of UDCA significantly decreased gallstone formation at 6 months at following BS. CLINICALTRIALS.
GOV NUMBER


NCT02319629.",2020,"Moreover, no between-group differences were found for blood test results (p ≥ 0.063 for all).
","['bariatric surgery', 'subjects who completed the study, 77.2% were women, and their mean age and pre-surgery BMI were 42.2\u2009±\u200910.2\xa0years and 44.4\u2009±\u20096.1\xa0kg/m 2 , respectively', '209 subjects were enrolled in the study, and 92 subjects completed the study and were analyzed (n\u2009=\u200946 for each study group']","['bariatric surgery (BS', 'UDCA', 'UDCA vs. an identical-looking placebo', 'placebo vs. UDCA', 'ursodeoxycholic acid (UDCA) vs. placebo']","['blood test results', 'Excess Weight Loss', 'gallstone formation', 'OAGB/RYGB', 'Gallstone formation', 'prescribed comorbidity medications', 'gallstone formation, as measured by abdominal ultrasound']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",209.0,0.491134,"Moreover, no between-group differences were found for blood test results (p ≥ 0.063 for all).
","[{'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Sakran', 'Affiliation': 'Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel. sakranas@gmail.com.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Dar', 'Affiliation': 'Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Assalia', 'Affiliation': 'The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Neeman', 'Affiliation': 'The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Moaad', 'Initials': 'M', 'LastName': 'Farraj', 'Affiliation': 'Department of Surgery, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Sherf-Dagan', 'Affiliation': 'Department of Nutritional Sciences, School of Health Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Gralnek', 'Affiliation': 'The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Rawi', 'Initials': 'R', 'LastName': 'Hazzan', 'Affiliation': 'Ellen and Pinchas Mamber Institute of Gastroenterology, Hepatology, and Nutrition, Emek Medical Center, Afula, Israel.'}, {'ForeName': 'Shams Eldin', 'Initials': 'SE', 'LastName': 'Mokary', 'Affiliation': 'Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel.'}, {'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Nevo-Aboody', 'Affiliation': 'Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Dola', 'Affiliation': 'Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Kaplan', 'Affiliation': 'Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hershko', 'Affiliation': 'Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel.'}]",Updates in surgery,['10.1007/s13304-020-00850-2']
2476,32666576,Clinical and cost effectiveness of a multi-professional medication reviews in care homes (CAREMED).,"OBJECTIVES


With 70% of care home residents experiencing a medication error every day in the UK, better multi-professional working between medical practitioners, pharmacists and care homes was recommended. The aim of this study was to determine the effectiveness (falls reduction) and cost-effectiveness, of a multi-professional medication review (MPMR) service in care homes for older people.
METHOD


A total of care homes in the East of England were cluster randomised to 'usual care' or two multi-professional (General practitioner, clinical pharmacist and care homes staff) medication reviews during the 12-month trial period. Target recruitment was 900 residents with 10% assumed loss to follow-up. Co-primary outcome measures were number of falls and potentially inappropriate prescribing assessed by the Screening Tool of Older Persons Prescriptions.
KEY FINDINGS


A total of 826 care home residents were recruited with 324 lost to follow-up for at least one primary outcome measure. The mean number of falls per resident per annum was 3.3 for intervention and 3.0 for control (P = 0.947). Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046). No significant difference identified in emergency hospital admissions or deaths. Estimated unadjusted incremental mean cost per resident was £374.26 higher in the intervention group.
CONCLUSIONS


In line with other medication review based interventions in care homes, two MPMRs improved medication appropriateness but failed to demonstrate improvements in clinical outcomes. From a health system perspective costs where estimated to increase overall and therefore a different model of medicines management is required.",2020,Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046).,"['826 care home residents were recruited with 324 lost to follow-up for at least one primary outcome measure', '900 residents with 10% assumed loss to follow-up', 'care homes for older people', ""A total of care homes in the East of England were cluster randomised to 'usual care' or two multi-professional (General practitioner, clinical pharmacist and care homes staff) medication"", 'With 70% of care home residents experiencing a medication error every day in the UK, better multi-professional working between medical practitioners, pharmacists and care homes']","['multi-professional medication review (MPMR) service', 'multi-professional medication']","['mean number of falls per resident per annum', 'effectiveness (falls reduction) and cost-effectiveness', 'emergency hospital admissions or deaths', 'number of falls and potentially inappropriate prescribing assessed by the Screening Tool of Older Persons Prescriptions']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184673', 'cui_str': 'Emergency hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C4305312', 'cui_str': ""STOPP - Screening Tool of Older Person's Prescriptions""}]",900.0,0.0886087,Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046).,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Desborough', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Houghton', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Sach', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Shaw', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Viveca', 'Initials': 'V', 'LastName': 'Kirthisingha', 'Affiliation': 'Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, George Davies Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}]",The International journal of pharmacy practice,['10.1111/ijpp.12656']
2477,32666599,"Human Fetal Cell Therapy in Huntington's Disease: A Randomized, Multicenter, Phase II Trial.","BACKGROUND


Huntington's disease is a rare, severe, inherited neurodegenerative disease in which we assessed the safety and efficacy of grafting human fetal ganglionic eminence intrastriatally.
METHODS


Patients at the early stage of the disease were enrolled in the Multicentric Intracerebral Grafting in Huntington's Disease trial, a delayed-start phase II randomized study. After a run-in period of 12 months, patients were randomized at month 12 to either the treatment group (transplanted at month 13-month 14) or the control group and secondarily treated 20 months later (month 33-month 34). The primary outcome was total motor score compared between both groups 20 months postrandomization (month 32). Secondary outcomes included clinical, imaging, and electrophysiological findings and a comparison of pregraft and postgraft total motor score slopes during the entire study period (month 0- month 52) regardless of the time of transplant.
RESULTS


Of 54 randomized patients, 45 were transplanted; 26 immediately (treatment) and 19 delayed (control). Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31). Its rate of decline after transplantation was similar to that before transplantation. A total of 27 severe adverse events were recorded in the randomized patients, 10 of which were related to the transplant procedure. Improvement of procedures during the trial significantly decreased the frequency of surgical events.We found antihuman leucocytes antigen antibodies in 40% of the patients.
CONCLUSION


No clinical benefit was found in this trial. This may have been related to graft rejection. Ectopia and high track number negatively influence the graft outcome. Procedural adjustments substantially improved surgical safety. (ClinicalTrials.gov NCT00190450.) © 2020 International Parkinson and Movement Disorder Society.",2020,"Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31).","[""Huntington's Disease"", ""Patients at the early stage of the disease were enrolled in the Multicentric Intracerebral Grafting in Huntington's Disease trial, a delayed-start phase II randomized study"", '54 randomized patients', '40% of the patients']",['Human Fetal Cell Therapy'],"['total motor score', 'antihuman leucocytes antigen antibodies', 'surgical safety', 'frequency of surgical events', 'Mean total motor score', 'clinical, imaging, and electrophysiological findings and a comparison of pregraft and postgraft total motor score slopes']","[{'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0439170', 'cui_str': '% fetal cells'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",54.0,0.162444,"Mean total motor score at month 32 did not differ between groups (treated controls difference in means adjusted for M12: +2.9 [95% confidence interval, -2.8 to 8.6]; P = 0.31).","[{'ForeName': 'Anne-Catherine', 'Initials': 'AC', 'LastName': 'Bachoud-Lévi', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, National Reference Center for Huntington's Disease, Neurology Department, Henri Mondor-Albert Chenevier Hospital, Créteil, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28201']
2478,32666638,Effect of a psychological nursing intervention on quality of life and cognitive function in patients with gastric carcinoma: A randomised controlled trial.,"AIM


We aimed to evaluate the effect of a psychological nursing intervention on quality of life (QoL) and cognitive function in patients with gastric carcinoma (GC) and proposed that the intervention might improve the QoL and cognitive function of GC patients.
METHODS


Gastric carcinoma patients were randomly assigned into two groups: (a) intervention group: receiving proper psychological nursing intervention; (b) control group: receiving conventional care.
RESULTS


The QoL and Montreal Cognitive Assessment (MoCA) scores at each dimensionality between the intervention group and the control group at baseline showed no significant differences (p > .05). However, after the 6-month psychological nursing intervention, 5 of 10 dimensionalities in QoL and 5 of 6 dimensionalities in MoCA showed statistically differences between the intervention group and the control group (p < .05). In comparison with the scores at baseline, the QoL scores measured after the 6-month psychological nursing intervention showed remarkable improvement in multiple dimensionalities in the intervention group, but only appetite loss improved in the control group. MoCA scores in multiple dimensionalities in the intervention group also exhibited obvious improvement compared with those in control group.
CONCLUSION


A psychological nursing intervention benefits the QoL and cognitive function in GC patients, indicating the importance of a psychological nursing intervention.",2020,"In comparison with the scores at baseline, the QoL scores measured after the 6-month psychological nursing intervention showed remarkable improvement in multiple dimensionalities in the intervention group, but only appetite loss improved in the control group.","['Gastric carcinoma patients', 'patients with gastric carcinoma (GC', 'patients with gastric carcinoma']","['intervention group: receiving proper psychological nursing intervention; (b) control group: receiving conventional care', 'psychological nursing intervention']","['multiple dimensionalities', 'QoL and Montreal Cognitive Assessment (MoCA) scores', 'quality of life (QoL) and cognitive function', 'MoCA scores', 'QoL scores', 'appetite loss', 'quality of life and cognitive function']","[{'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}]",,0.0231447,"In comparison with the scores at baseline, the QoL scores measured after the 6-month psychological nursing intervention showed remarkable improvement in multiple dimensionalities in the intervention group, but only appetite loss improved in the control group.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Lingshu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}]",European journal of cancer care,['10.1111/ecc.13292']
2479,32667053,Improving mother-infant interaction during infant feeding: A randomised controlled trial in a low-income community in South Africa.,"BACKGROUND


Maternal-infant feeding interactions are a primary context for engagement between mothers and their infants, and constitute a unique space in which reciprocity, attunement and maternal sensitivity can be expressed. Increasingly, research demonstrates the importance of the psychological and social nature of the feeding context, and how it may be affected by maternal mental state, feeding skills and sensitivity. As such, feeding interactions may provide useful contexts for observations of maternal sensitivity, reflecting well on day-to-day maternal sensitivity.
AIMS AND OBJECTIVES


This paper is a post hoc examination of the impact of an intervention on maternal sensitivity during a feeding interaction when the infants were 6 months old.
PARTICIPANTS


A total of 449 women consented to participate in the original intervention and were randomly assigned to the intervention or control groups. Mothers and infants were assessed during pregnancy, and then at 2, 6, 12 and 18 months of infant age. At the 6 month follow-up visit, 79% (354 out of 449) of the participants were retained. Post hoc analyses were conducted on the original sample to determine breastfeeding status. Sixty-nine percent of the women completed the feeding observation at the 6 months follow-up visit, of which 47% reported exclusively breastfeeding and 22% reported bottle-feeding.
RESULTS


Results demonstrated that during a feeding interaction, maternal sensitivity was significantly improved among non-breastfeeding mothers who received the intervention. Particularly, maternal responsiveness to infant cues and synchronous interactions was higher among non-breastfeeding intervention mothers compared to control group mothers. The results also show that non-breastfeeding mothers who received the intervention were significantly less intrusive in their interactions with their infants.
CONCLUSION


The intervention had particular beneficial effects for mothers who were not breastfeeding and suggest that the intervention offered a protective effect for non-breastfeeding mothers.",2020,"Particularly, maternal responsiveness to infant cues and synchronous interactions was higher among non-breastfeeding intervention mothers compared to control group mothers.","['A total of 449 women consented to participate in the original intervention', 'low-income community in South Africa']",[],"['maternal responsiveness to infant cues and synchronous interactions', 'maternal sensitivity', 'feeding interaction, maternal sensitivity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]",449.0,0.031233,"Particularly, maternal responsiveness to infant cues and synchronous interactions was higher among non-breastfeeding intervention mothers compared to control group mothers.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rabie', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Skeen', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Xanthe', 'Initials': 'X', 'LastName': 'Hunt', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Department of Psychology, University of Reading, Reading, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychology, University of Reading, Reading, UK.'}]",Infant mental health journal,['10.1002/imhj.21881']
2480,32667105,Culturally Tailored Evidence-based Substance Use Disorder Treatments are Efficacious with an American Indian Southwest Tribe: An Open-label Pilot-feasibility Randomized Controlled Trial.,"BACKGROUND AND AIMS


Many evidence-based treatments (EBTs) for substance use disorder (SUD) exist, yet few are tailored to Indigenous patients. This trial tested the efficacy of a culturally tailored EBT that combined motivational interviewing and the Community Reinforcement Approach (MICRA) versus Treatment as Usual (TAU).
DESIGN


A mixed efficacy/effectiveness randomized controlled trial of MICRA (n=38) and TAU (n=41) using a parallel design with follow-up assessments at 4, 8, and 12 months post baseline.
SETTING


United States, reservation-based outpatient, addiction specialty care treatment program.
PARTICIPANTS


79 (68% male) American Indian and Alaska Native (AI/AN) Tribal members meeting criteria for SUD and seeking SUD treatment.
INTERVENTIONS


MICRA (individual therapy sessions beginning with MI for 2 to 3 sessions) compared with TAU (individual and group counseling sessions in a didactic style with Twelve-Step philosophy and elements of relapse prevention).
MEASURES


Demographics, percent days abstinent (PDA; the primary outcome at 12 months assessed by Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self-Efficacy Scale, Native American Spirituality Scale, and SCID-DSM-IV-TR.
FINDINGS


There was no evidence for the benefit of MICRA over TAU (MICRA PDA=72.63%, TAU=73.62%, treatment effect: B: -4.04 (SE=5.47); 95% CI: -14.941, 6.866; BF=3.44) in the primary outcome. Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12-month follow-up. Neither self-efficacy nor spirituality were significant mediators of MICRA.
CONCLUSIONS


There were no treatment group differences between culturally tailored evidence-based treatments for substance use disorder and treatment as usual in this randomized controlled trial with American Indian and Alaska Native participants. Nonetheless, participants improved over time on several substance-related outcomes.",2020,"Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12-month follow-up.","['79 (68% male) American Indian and Alaska Native (AI/AN', 'United States, reservation-based outpatient, addiction specialty care treatment program', 'n=38) and TAU (n=41', 'American Indian and Alaska Native participants', 'Tribal members meeting criteria for SUD and seeking SUD treatment', 'American Indian Southwest Tribe']","['MICRA', 'Culturally Tailored Evidence-based Substance Use Disorder Treatments', 'culturally tailored EBT that combined motivational interviewing and the Community Reinforcement Approach (MICRA) versus Treatment as Usual (TAU', 'MICRA (individual therapy sessions beginning with MI for 2 to 3 sessions) compared with TAU (individual and group counseling sessions']","['Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self-Efficacy Scale, Native American Spirituality Scale, and SCID-DSM-IV-TR', 'PDA, SUD severity, and negative consequences']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}]","[{'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0085110', 'cui_str': 'Severe combined immunodeficiency disease'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.107365,"Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12-month follow-up.","[{'ForeName': 'Kamilla L', 'Initials': 'KL', 'LastName': 'Venner', 'Affiliation': 'Department of Psychology, University of New Mexico.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Serier', 'Affiliation': 'Department of Psychology, University of New Mexico.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Sarafin', 'Affiliation': 'Department of Psychology, University of New Mexico.'}, {'ForeName': 'Brenna L', 'Initials': 'BL', 'LastName': 'Greenfield', 'Affiliation': 'University of Minnesota, Duluth Medical School.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hirchak', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addiction.'}, {'ForeName': 'Jane Ellen', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, University of New Mexico.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico.'}]","Addiction (Abingdon, England)",['10.1111/add.15191']
2481,32667151,Combination of in-situ collagen injection and rehabilitative treatment in longlasting facial nerve palsy: a pilot randomized controlled trial.,"BACKGROUND


Many rehabilitative attempts have been made to prevent or reduce residual deficits in patients with established and long-term facial palsy (FP). In many clinical settings in-situ injection of collagen-based medical devices (MDs) have been demonstrated to provide nutritional support for tissues.
AIM


To test the effectiveness of a collagen-based treatment for patients complaining of long standing FP, who are following a proprioceptive neuromuscular facilitation protocol (Kabat method) (Group A), compared to a FP group only undergoing the Kabat method (Group B).
DESIGN


Randomised controlled trial.
SETTING


Tertiary referral outpatient center and University Hospital.
POPULATION


41 patients with a medical diagnosis of long-term unilateral peripheral FP.
METHODS


Twenty-one Group A patients were compared, after randomization, to nineteen matched Group B patients after 8 weeks of treatment. The outcomes were electromyographic findings, validated questionnaires (Facial Disability Index, FDI and General health-related quality of life assessment, QOL) and clinical grading (House-Brackmann, HB, and synkinesis grading scale). A correlation analysis was performed between pre-/post-treatment differences (Δ) in outcome and clinical-demographic measures.
RESULTS


A significant within-subjects improvement, both in electrophysiological and questionnaire scores, was found in both groups. When compared with Group B, Group A patients exhibited a significant reduction of post-treatment polyphasic potentials of voluntary activity of orbicularis oculi (p = 0.017) and oris (p = 0.015) and a significant increase in post-treatment duration of voluntary activity of orbicularis oris (p = 0.018). Group A subjects demonstrated a significant improvement in questionnaire subscales regarding overall disease perception. Although positive correlations between the ΔFDI and Δpercentage of polyphasic potentials of voluntary activity were found in both groups, negative correlations in Group A were found between disease duration and Δduration of voluntary activity of orbicularis oculi and oris.
CONCLUSIONS


The combination of physical rehabilitative procedures with in-situ collagen injections, possibly acting in redirecting the phenomena of reinnervation/reorganization, demonstrated encouraging results in patients affected by long term FP.
CLINICAL REHABILITATION IMPACT


In-situ collagen injection could be a safe option enlarging the 'window of opportunity' to improve the voluntary muscle contraction pattern and general and specific disability referred by patients affected by long standing FP.",2020,"When compared with Group B, Group A patients exhibited a significant reduction of post-treatment polyphasic potentials of voluntary activity of orbicularis oculi (p = 0.017) and oris (p = 0.015) and a significant increase in post-treatment duration of voluntary activity of orbicularis oris (p = 0.018).","['41 patients with a medical diagnosis of long-term unilateral peripheral FP', 'patients with established and long-term facial palsy (FP', 'longlasting facial nerve palsy', 'Tertiary referral outpatient center and University Hospital', 'patients complaining of long standing FP, who are following a proprioceptive neuromuscular facilitation protocol (Kabat method) (Group A), compared to a FP group only undergoing the Kabat method (Group B']","['collagen-based treatment', 'collagen-based medical devices (MDs', 'situ collagen injection and rehabilitative treatment']","['electromyographic findings, validated questionnaires (Facial Disability Index, FDI and General health-related quality of life assessment, QOL) and clinical grading (House-Brackmann, HB, and synkinesis grading scale', 'questionnaire subscales regarding overall disease perception', 'polyphasic potentials of voluntary activity', 'electrophysiological and questionnaire scores', 'post-treatment duration of voluntary activity of orbicularis oris']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C3266178', 'cui_str': 'Peripheral facial palsy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0015464', 'cui_str': 'Facial nerve disorder'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0234362', 'cui_str': 'Synkinesis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0224147', 'cui_str': 'Orbicularis oris muscle structure'}]",41.0,0.0572303,"When compared with Group B, Group A patients exhibited a significant reduction of post-treatment polyphasic potentials of voluntary activity of orbicularis oculi (p = 0.017) and oris (p = 0.015) and a significant increase in post-treatment duration of voluntary activity of orbicularis oris (p = 0.018).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Micarelli', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy - alessandromicarelli@yahoo.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Viziano', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Granito', 'Affiliation': 'ITER Center for Balance and Rehabilitation Research (ICBRR), Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Antonuccio', 'Affiliation': 'ITER Center for Balance and Rehabilitation Research (ICBRR), Rome, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Felicioni', 'Affiliation': 'ITER Center for Balance and Rehabilitation Research (ICBRR), Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Loberti', 'Affiliation': 'DOPSITERE Rome, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Carlino', 'Affiliation': 'ITER Center for Balance and Rehabilitation Research (ICBRR), Rome, Italy.'}, {'ForeName': 'Riccardo X', 'Initials': 'RX', 'LastName': 'Micarelli', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alessandrini', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06393-5']
2482,32667155,Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting: The iMODIPONV Randomized Controlled Trial.,"BACKGROUND


Suboptimal tissue perfusion and oxygenation during surgery may be responsible for postoperative nausea and vomiting in some patients. This trial tested the hypothesis that muscular tissue oxygen saturation-guided intraoperative care reduces postoperative nausea and vomiting.
METHODS


This multicenter, pragmatic, patient- and assessor-blinded randomized controlled (1:1 ratio) trial was conducted from September 2018 to June 2019 at six teaching hospitals in four different cities in China. Nonsmoking women, 18 to 65 yr old, and having elective laparoscopic surgery involving hysterectomy (n = 800) were randomly assigned to receive either intraoperative muscular tissue oxygen saturation-guided care or usual care. The goal was to maintain muscular tissue oxygen saturation, measured at flank and on forearm, greater than baseline or 70%, whichever was higher. The primary outcome was 24-h postoperative nausea and vomiting. Secondary outcomes included nausea severity, quality of recovery, and 30-day morbidity and mortality.
RESULTS


Of the 800 randomized patients (median age, 50 yr [range, 27 to 65]), 799 were assessed for the primary outcome. The below-goal muscular tissue oxygen saturation area under the curve was significantly smaller in patients receiving muscular tissue oxygen saturation-guided care (n = 400) than in those receiving usual care (n = 399; flank, 50 vs. 140% · min, P < 0.001; forearm, 53 vs. 245% · min, P < 0.001). The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251). There were no significant between-group differences for secondary outcomes. No harm was observed throughout the study.
CONCLUSIONS


In a relatively young and healthy female patient population, personalized, goal-directed, muscular tissue oxygen saturation-guided intraoperative care is effective in treating decreased muscular tissue oxygen saturation but does not reduce the incidence of 24-h posthysterectomy nausea and vomiting.",2020,"The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251).","['September 2018 to June 2019 at six teaching hospitals in four different cities in China', 'Nonsmoking women, 18 to 65 yr old, and having elective laparoscopic surgery involving hysterectomy (n = 800', '800 randomized patients (median age, 50 yr [range, 27 to 65']","['muscular tissue oxygen saturation-guided intraoperative care', 'intraoperative muscular tissue oxygen saturation-guided care or usual care']","['postoperative nausea and vomiting', '24-h postoperative nausea and vomiting', 'nausea severity, quality of recovery, and 30-day morbidity and mortality', 'Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting', 'incidences of 24-h postoperative nausea and vomiting', 'muscular tissue oxygen saturation']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021889', 'cui_str': 'Intraoperative care'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",800.0,0.311572,"The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, Peking University Third Hospital, Beijing, China (G.L., X.G.) the Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China (D.-D.T., Y.-Q.A., J.-J.Y.) the Department of Anesthesiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong Province, China (X.W., M.Z.) the Department of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China (X.F., Y.L.) the Department of Anesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China (W.Z., M.X., X.C.) the Department of Anesthesiology, Peking University First Hospital, Beijing, China (J.B., D.-X.W., D.-L.M.) the Department of Biostatistics, Yale University School of Public Health, Yale Center for Analytical Sciences, New Haven, Connecticut (F.D.) the Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut (X.Z., D.Y., L.M.).'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Ai', 'Affiliation': ''}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Dai', 'Affiliation': ''}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Che', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yanez', 'Affiliation': ''}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Lingzhong', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003305']
2483,32667240,An unexpected visitor and a sword play: a randomized controlled trial of collective narrative therapy groups for primary carers of people with schizophrenia.,"BACKGROUND


Most family carer support programs focus on supporting carers with caregiving-related knowledge and skills to help their family members who suffer from schizophrenia in their recovery process while carers' inner resources and preferred identities are less emphasized in the existing studies.
AIMS


The present study uses collective narrative therapy groups (CNTG) to promote the inner strengths and agency of family carers and help them to explore their preferred identities while caring for family members with schizophrenia.
METHOD


To ensure an evidence-based intervention, 89 Chinese family carers of people with schizophrenia took part in this three-wave longitudinal program evaluation study using a randomized controlled trial design.
RESULTS


Compared with the control group, family carers in CNTG reported better family relationships, a lesser caregiving burden, and more perceived inner resources. Repeated one-way ANOVA revealed that CNTG improved family relationships, the caregiving burden, the level of hope and inner resources in the posttest, and a statistically significantly better mental health condition in the follow-up.
CONCLUSION


This study shows that collective narrative psychotherapy is effective in supporting family carers of people with schizophrenia in Hong Kong. Based on the research findings, we discuss the strengths of the program and its implications for practitioners.",2020,"Compared with the control group, family carers in CNTG reported better family relationships, a lesser caregiving burden, and more perceived inner resources.","['family members with schizophrenia', 'family carers of people with schizophrenia in Hong Kong', '89 Chinese family carers of people with schizophrenia took part in this three-wave longitudinal program evaluation study', 'primary carers of people with schizophrenia']","['collective narrative therapy groups (CNTG', 'collective narrative therapy', 'collective narrative psychotherapy']","['mental health condition', 'caregiving burden, the level of hope and inner resources']","[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0033336', 'cui_str': 'Evaluation, Program'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}]","[{'cui': 'C3494322', 'cui_str': 'Narrative Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424133', 'cui_str': 'Level of hope'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",89.0,0.0406408,"Compared with the control group, family carers in CNTG reported better family relationships, a lesser caregiving burden, and more perceived inner resources.","[{'ForeName': 'De-Hui Ruth', 'Initials': 'DR', 'LastName': 'Zhou', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, Hong Kong, Hong Kong.'}, {'ForeName': 'Yu-Lung Marcus', 'Initials': 'YM', 'LastName': 'Chiu', 'Affiliation': 'Department of Applied Social Science, City University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Tak-Lam William', 'Initials': 'TW', 'LastName': 'Lo', 'Affiliation': 'Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Wai-Fan Alison', 'Initials': 'WA', 'LastName': 'Lo', 'Affiliation': 'Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Siu-Sing', 'Initials': 'SS', 'LastName': 'Wong', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Hoi Tom', 'Initials': 'CHT', 'LastName': 'Leung', 'Affiliation': 'Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Chui-Kam', 'Initials': 'CK', 'LastName': 'Yu', 'Affiliation': 'Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Yuk Sing Geoffrey', 'Initials': 'YSG', 'LastName': 'Chang', 'Affiliation': 'Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Kwok-Leung', 'Initials': 'KL', 'LastName': 'Luk', 'Affiliation': 'Kwai Chung Hospital, Kowloon, Hong Kong.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2020.1793123']
2484,32667254,Improvements in well-being and cardiac metrics of stress following a yogic breathing workshop: Randomized controlled trial with active comparison.,"Objective:  Compare two distinct psychosocial stress-management workshops. Participants:  Undergraduate and graduate students ( n  = 69 for analysis, completed April 2017). Methods:  Participants were randomized to one of two workshops (Sudarshan Kriya Yoga, SKY; Wisdom On Wellness, WOW), matched in terms of duration, group size, etc. Outcomes were questionnaires and psychophysiological response to laboratory stress induction at pre, post, and 3-month follow-up. Results:  SKY and WOW participants demonstrated similar workshop ratings and retention rates. SKY demonstrated greater improvements on a number of self-report measures relative to WOW, including perceived stress, sleep, social connectedness, distress, anxiety, depression, conscientiousness, self-esteem, and life satisfaction. Both groups improved in terms of heart rate measures of stress reactivity, however, these outcomes were partially related to changes in resting values at post-workshop and follow-up. Conclusions:  These findings offer insight into unique patterns of change between yogic breathing, acceptance-based approaches to stress management versus cognitively based approaches.",2020,"SKY demonstrated greater improvements on a number of self-report measures relative to WOW, including perceived stress, sleep, social connectedness, distress, anxiety, depression, conscientiousness, self-esteem, and life satisfaction.","['Participants:  Undergraduate and graduate students ( n \u2009=\u200969 for analysis, completed April 2017']","['workshops (Sudarshan Kriya Yoga, SKY; Wisdom On Wellness, WOW', 'yogic breathing workshop']","['number of self-report measures relative to WOW, including perceived stress, sleep, social connectedness, distress, anxiety, depression, conscientiousness, self-esteem, and life satisfaction', 'questionnaires and psychophysiological response to laboratory stress induction', 'workshop ratings and retention rates', 'heart rate measures of stress reactivity']","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0301560', 'cui_str': 'Ski'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.04502,"SKY demonstrated greater improvements on a number of self-report measures relative to WOW, including perceived stress, sleep, social connectedness, distress, anxiety, depression, conscientiousness, self-esteem, and life satisfaction.","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Rivian K', 'Initials': 'RK', 'LastName': 'Lewin', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, Tennessee, USA.'}, {'ForeName': 'John J B', 'Initials': 'JJB', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, Arizona, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1781867']
2485,32667270,Prospective Long-term Follow-up of Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation: A Randomized Clinical Trial.,"BACKGROUND


Matrix-associated autologous chondrocyte implantation (MACI) is a further development of the original autologous chondrocyte implantation periosteal flap technique (ACI-P) for the treatment of articular cartilage defects.
PURPOSE


We aimed to establish whether MACI or ACI-P provides superior long-term outcomes in terms of patient satisfaction, clinical assessment, and magnetic resonance imaging (MRI) evaluation.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 21 patients with cartilage defects at the femoral condyle were randomized to MACI (n = 11) or ACI-P (n = 10) between the years 2004 and 2006. Patients were assessed for subjective International Knee Documentation Committee (IKDC) score, Lysholm and Gillquist score, Tegner Activity Score, and 36-Item Short Form Health Survey (SF-36) preoperatively (T0), at 1 and 2 years postoperatively (T1, T2), and at the final follow-up 8 to 11 years after surgery (T3). Onset of osteoarthritis was determined using the Kellgren-Lawrence score and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and delayed gadolinium-enhanced MRI of cartilage was used to evaluate the cartilage. Adverse events were recorded to assess safety.
RESULTS


There were 16 patients (MACI, n = 9; ACI-P, n = 7) who were reassessed on average 9.6 years after surgery (76% follow-up rate). The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2. IKDC scores increased significantly at all postoperative evaluation time points in ACI-P. In MACI, IKDC scores showed a significant increase at T1 and T3 when compared with T0. In the majority of the patients (10/16; MACI, 5/9; ACI-P, 5/7) a complete defect filling was present at the final follow-up as shown by the MOCART score, and 1 patient in the ACI-P group displayed hypertrophy of the repair tissue, which represents 6% of the whole study group and 14.3% of the ACI-P group. Besides higher SF-36 vitality scores in ACI-P at T3, no significant differences were seen in clinical scores and MRI scores between the 2 methods at any time point. Revision rate was 33.3% in MACI and 28.6% in ACI-P at the last follow-up.
CONCLUSION


Our long-term results suggest that first- and third-generation ACI methods are equally effective treatments for isolated full-thickness cartilage defects of the knee. With the number of participants available, no significant difference was noted between MACI and ACI-P at any time point. Interpretation of our data has to be performed with caution due to the small sample size, which was further limited by a loss to follow-up of 24%.",2020,The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2.,"['A total of 21 patients with cartilage defects at the femoral condyle', 'n = 11) or ACI-P (n = 10) between the years 2004 and 2006']","['MACI', 'Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation', 'MACI or ACI-P', 'Matrix-associated autologous chondrocyte implantation (MACI']","['Kellgren-Lawrence score and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and delayed gadolinium-enhanced MRI of cartilage', 'hypertrophy of the repair tissue', 'SF-36 vitality scores', 'Adverse events', 'complete defect filling', 'MACI, IKDC scores', 'Revision rate', 'clinical scores and MRI scores', 'Lysholm and Gillquist score', 'IKDC scores', 'subjective International Knee Documentation Committee (IKDC) score, Lysholm and Gillquist score, Tegner Activity Score, and 36-Item Short Form Health Survey (SF-36) preoperatively (T0']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0582800', 'cui_str': 'Condyle of femur'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0031110', 'cui_str': 'Periosteum'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Level'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",21.0,0.102406,The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barié', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Kruck', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sorbi', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rehnitz', 'Affiliation': 'Diagnostic and Interventional Radiology, Department of Radiology, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Oberle', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Walker', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zeifang', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moradi', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520928337']
2486,32667286,"Safety, pharmacokinetics and pharmacodynamics of selgantolimod, an oral Toll-like receptor 8 agonist: a Phase Ia study in healthy subjects.","BACKGROUND


Selgantolimod is a novel oral, selective Toll-like receptor 8 (TLR8) agonist in development for the treatment of chronic hepatitis B (CHB). TLR8 is an endosomal innate immune receptor and a target for treatment of viral infections. This first-in-human study investigated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of selgantolimod in healthy volunteers.
METHODS


Of 71 subjects enrolled, 59 received a single dose of selgantolimod (0.5, 1.5, 3, or 5 mg) or placebo, and 12 were evaluated for food effect. Safety, pharmacokinetics and pharmacodynamic activity by induction of cytokines, chemokines and acute phase proteins were assessed. PK/PD analyses were conducted.
RESULTS


Single doses of 0.5-5 mg were generally safe. No serious adverse events (AEs) or AEs leading to discontinuation were reported, and most were Grade 1 in severity. Selgantolimod displayed rapid absorption and dose-proportional PK and PD activity. Food had minimal effect on PK but resulted in diminished PD activity. In PK/PD analyses, near-saturation of induction for most evaluated biomarkers occurred at the 5-mg dose.
CONCLUSIONS


Single doses of up to 5 mg selgantolimod were safe and induced dose-dependent PD responses. These data support evaluation of selgantolimod in combination with other agents in future clinical studies of CHB.",2020,"No serious adverse events (AEs) or AEs leading to discontinuation were reported, and most were Grade 1 in severity.","['Of 71 subjects enrolled', 'healthy volunteers', 'healthy subjects']","['placebo', 'TLR8', 'selgantolimod']","['Safety, pharmacokinetics and pharmacodynamic activity', 'rapid absorption and dose-proportional PK and PD activity', 'PD activity', 'Safety, pharmacokinetics and pharmacodynamics', 'serious adverse events (AEs) or AEs leading to discontinuation', 'safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0962444', 'cui_str': 'TLR8 protein, human'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",71.0,0.0573114,"No serious adverse events (AEs) or AEs leading to discontinuation were reported, and most were Grade 1 in severity.","[{'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Reyes', 'Affiliation': 'Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Lutz', 'Affiliation': 'Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Audrey H', 'Initials': 'AH', 'LastName': 'Lau', 'Affiliation': 'Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Ethan P', 'Initials': 'EP', 'LastName': 'Grant', 'Affiliation': 'Biology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Adarsh', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Biostatistics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Mackman', 'Affiliation': 'Medicinal Chemistry, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Bioanalytical Chemistry, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Susanna K', 'Initials': 'SK', 'LastName': 'Tan', 'Affiliation': 'Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Natarajan', 'Initials': 'N', 'LastName': 'Ayithan', 'Affiliation': 'Institute of Human Virology, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Daffis', 'Affiliation': 'Biology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Biology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Biostatistics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'Clinical Operations, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Fletcher', 'Affiliation': 'Biology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Shyamasundaran', 'Initials': 'S', 'LastName': 'Kottilil', 'Affiliation': 'Institute of Human Virology, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Poonia', 'Affiliation': 'Institute of Human Virology, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathias', 'Affiliation': 'Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'German', 'Affiliation': 'Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.'}]",Antiviral therapy,['10.3851/IMP3363']
2487,32667287,Argatroban Increased the Basal Vein Drainage and Improved Outcomes in Acute Paraventricular Ischemic Stroke Patients.,"BACKGROUND Since venous drainage in acute arterial ischemic stroke has not been thoroughly researched, we evaluate the effect of argatroban, a selective direct thrombin inhibitor, as a therapy to increase the rate of basal vein Rosenthal (BVR) drainage and improve patients' post-stroke outcomes. MATERIAL AND METHODS In this multicenter clinical trial, 60 eligible patients at 4.5 to 48 hours after the stroke onset were recruited. After being randomly allocated into 2 groups, they were treated with standard therapy either alone or with argatroban. RESULTS Compared to the contralateral brain hemisphere, the mean flow velocity (MFV) in BVR drainage was significantly reduced in the stroke-afflicted ipsilateral hemisphere. After treatment with argatroban for 7 days, the MFV from BVR of the ipsilateral hemisphere in the argatroban treated group was significantly increased when compared to the control group. At 90 days after the onset of stroke, the MFV of BVR in the ipsilateral hemisphere was similar in both groups. Compared with controls, the argatroban-treated patients had smaller lesions from baseline to 7 days. Argatroban also improved National Institutes of Health Stroke Scale (NIHSS) scores on day 7 after the onset of stroke. Furthermore, the argatroban group's neurological functions were superior to those of their untreated counterparts after 90 days. No difference was found in the incidence of adverse reactions between the 2 groups. CONCLUSIONS These observations indicate that vein drainage change may contribute to the acute phase of brain edema and the outcomes of ischemic stroke patients.",2020,"Furthermore, the argatroban group's neurological functions were superior to those of their untreated counterparts after 90 days.","['60 eligible patients at 4.5 to 48 hours after the stroke onset were recruited', 'Acute Paraventricular Ischemic Stroke Patients', 'acute arterial ischemic stroke']","['standard therapy either alone or with argatroban', 'argatroban', 'Argatroban']","['neurological functions', 'MFV from BVR of the ipsilateral hemisphere', 'MFV of BVR', 'National Institutes of Health Stroke Scale (NIHSS) scores', 'Basal Vein Drainage', 'incidence of adverse reactions', 'rate of basal vein Rosenthal (BVR) drainage', 'mean flow velocity (MFV) in BVR drainage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}]","[{'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0004789', 'cui_str': 'Structure of basal vein'}, {'cui': 'C0015523', 'cui_str': 'Hereditary factor XI deficiency disease'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",60.0,0.0501248,"Furthermore, the argatroban group's neurological functions were superior to those of their untreated counterparts after 90 days.","[{'ForeName': 'Shoufeng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'The Graduate School, Tianjin Medical University, Tianjin, China (mainland).'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Tianjin Huanhu Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Po', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Baotou Central Hospital, Baotou, Inner Mongolia, China (mainland).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tianjin Fourth Central Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Ultrasonography, Tianjin Huanhu Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Tianjin Huanhu Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924593']
2488,32667383,"Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study.","Objective Our study seeks to investigate the effectiveness of kinesio taping (KT) on postoperative morbidity compared to placebo and control groups after impacted third molar surgery. Methodology Sixty patients with impacted mandibular third molar were included in this prospective, randomized, placebo-controlled clinical study. After surgical extraction of the impacted tooth, patients were allocated into three groups (20 patients each): group 1 received KT (kinesio), group 2 received placebo taping (placebo), and group 3 received no taping (control). The groups were compared regarding facial swelling, pain and trismus. Swelling was evaluated using a tape measuring method. Pain was assessed by a visual analog scale and the number of analgesic tablets taken. Trismus was determined by measuring maximum mouth opening. Results In the KT group, all parameters reduced significantly on 2nd and 4th postoperative days compared to other groups; however, placebo and control groups revealed comparable outcomes. On 7th day, all groups showed comparable results. Conclusions The KT application is an effective method for reducing morbidity after impacted mandibular third molar surgery. However, placebo taping is not as effective as proper taping. Placebo taping shows similar results compared to no taping regarding facial swelling percentage, pain and trismus.",2020,"In the KT group, all parameters reduced significantly on 2nd and 4th postoperative days compared to other groups; however, placebo and control groups revealed comparable outcomes.","['after impacted mandibular third molar surgery', 'Methodology Sixty patients with impacted mandibular third molar', 'and control groups after impacted third molar surgery']","['kinesio taping (KT', 'Placebo', 'kinesio taping', 'placebo taping (placebo), and group 3 received no taping (control', 'KT (kinesio', 'placebo']","['visual analog scale and the number of analgesic tablets taken', 'Swelling', 'Pain', 'postoperative morbidity', 'facial swelling percentage, pain and trismus', 'morbidity', 'Trismus', 'facial swelling, pain and trismus']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}]",60.0,0.249748,"In the KT group, all parameters reduced significantly on 2nd and 4th postoperative days compared to other groups; however, placebo and control groups revealed comparable outcomes.","[{'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Tatli', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Ilke Coskun', 'Initials': 'IC', 'LastName': 'Benlidayi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Fariz', 'Initials': 'F', 'LastName': 'Salimov', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Guzel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Cukurova University, Adana, Turkey.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0159']
2489,32667428,Brief antibullying intervention for adolescents in public schools.,"OBJECTIVES


To assess the results of a brief antibullying intervention for adolescents in public schools.
METHOD


This was a controlled experimental study whose subjects were 1,043 students in 5th through 9th grades from public schools in Porto Alegre/State of Rio Grande do Sul, conducted between April and November 2015. Adolescents and school teachers randomly assigned to the intervention group participated in two meetings focused on educative aspects of bullying. Outcome was assessed using the Bullying Questionnaire - victim and perpetrator version. Generalized Estimating Equations was used to evaluate the effect of the intervention.
RESULTS


Average age of subjects was 12.5 (SD=1.62) years. A total of 613 (58.7%) adolescents participated in interventions. They were compared to 430 (41.3%) participants in the control group. The study did not observe any significant difference in bullying scores after the intervention.
CONCLUSIONS


This study indicates the usefulness of clarifying precisely what bullying is in schools as part of an initial approach to an educative strategy on this topic.",2020,"The study did not observe any significant difference in bullying scores after the intervention.
","['adolescents in public schools', 'A total of 613 (58.7%) adolescents participated in interventions', 'Adolescents and school teachers', 'subjects were 1,043 students in 5th through 9th grades from public schools in Porto Alegre/State of Rio Grande do Sul, conducted between April and November 2015']",['Brief antibullying intervention'],"['bullying scores', 'Bullying Questionnaire - victim and perpetrator version']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.0229872,"The study did not observe any significant difference in bullying scores after the intervention.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bottan', 'Affiliation': 'Escola de Enfermagem, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Vizini', 'Affiliation': 'Escola de Enfermagem, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Pâmela Francine Oliveira', 'Initials': 'PFO', 'LastName': 'Alves', 'Affiliation': 'Escola de Enfermagem, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Luciano Santos Pinto', 'Initials': 'LSP', 'LastName': 'Guimarães', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Bianca Peixoto', 'Initials': 'BP', 'LastName': 'Nascimento', 'Affiliation': 'Escola de Enfermagem, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rigatti', 'Affiliation': 'Escola de Enfermagem, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil.'}, {'ForeName': 'Elizeth', 'Initials': 'E', 'LastName': 'Heldt', 'Affiliation': 'Escola de Enfermagem, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brasil.'}]",Revista gaucha de enfermagem,['10.1590/1983-1447.2020.20190336']
2490,32667582,Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer.,"INTRODUCTION


to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013.
METHODS


a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05.
RESULTS


fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment.
CONCLUSIONS


we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.",2020,No significant difference over time in the QLQC30 summary scores was observed (p>0.05).,"['fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019', 'high tumor burden ovarian cancer']","['short-course hyperthermic intraperitoneal chemotherapy (HIPEC', 'HIPEC']","['health-related quality of life (HRQoL', 'HRQoL questionnaire', 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0', 'safety and efficacy', 'Quality of life', 'QLQC30 summary scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0338411,No significant difference over time in the QLQC30 summary scores was observed (p>0.05).,"[{'ForeName': 'Roberto JosÉ Costa', 'Initials': 'RJC', 'LastName': 'Lustosa', 'Affiliation': 'Departamento de Cirurgia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.'}, {'ForeName': 'Thales Paulo', 'Initials': 'TP', 'LastName': 'Batista', 'Affiliation': 'Departamento de Cirurgia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.'}, {'ForeName': 'VandrÉ Cabral Gomes', 'Initials': 'VCG', 'LastName': 'Carneiro', 'Affiliation': 'Departamento de Cirurgia / Oncologia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.'}, {'ForeName': 'Levon', 'Initials': 'L', 'LastName': 'Badiglian-Filho', 'Affiliation': 'Departamento de Ginecologia, AC Camargo Cancer Center, São Paulo, SP, Brazil.'}, {'ForeName': 'Ronaldo LÚcio Rangel', 'Initials': 'RLR', 'LastName': 'Costa', 'Affiliation': 'Departamento de Ginecologia, Instituto Brasileiro de Controle do Câncer, São Paulo, SP, Brasil.'}, {'ForeName': 'AndrÉ', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Departamento de Ginecologia, Instituto Brasileiro de Controle do Câncer, São Paulo, SP, Brasil.'}, {'ForeName': 'Bruno JosÉ DE Queiroz', 'Initials': 'BJQ', 'LastName': 'Sarmento', 'Affiliation': 'Departamento de Oncologia Cirúrgica, Instituto Hospital de Base do Distrito Federal, Brasília, DF, Brasil.'}, {'ForeName': 'Jurema Telles DE Oliveira', 'Initials': 'JTO', 'LastName': 'Lima', 'Affiliation': 'Departamento de Oncologia Clínica, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.'}, {'ForeName': 'Maria Julia GonÇalves DE', 'Initials': 'MJG', 'LastName': 'Mello', 'Affiliation': 'Departamento de Pesquisa Clínica, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.'}, {'ForeName': 'Cristiano Souza', 'Initials': 'CS', 'LastName': 'LeÃo', 'Affiliation': 'Departamento de Cirurgia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.'}]",Revista do Colegio Brasileiro de Cirurgioes,['10.1590/0100-6991e-20202534']
2491,32667629,The Hydrocortisone vs Pasireotide in Reducing Pancreatic Surgery Complications Noninferiority Trial-Reply.,,2020,,[],['Hydrocortisone vs Pasireotide'],[],[],"[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]",[],,0.0904725,,"[{'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Tarvainen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki, Helsinki, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2020.2001']
2492,32667633,The Hydrocortisone vs Pasireotide in Reducing Pancreatic Surgery Complications Noninferiority Trial: Comparing Apples and Pears?,,2020,,[],['Hydrocortisone vs Pasireotide'],[],[],"[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]",[],,0.0869058,,"[{'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Adiamah', 'Affiliation': ""Department of Hepatobiliary and Pancreatic Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, England.""}, {'ForeName': 'Anisa', 'Initials': 'A', 'LastName': 'Kushairi', 'Affiliation': ""Department of Hepatobiliary and Pancreatic Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, England.""}, {'ForeName': 'Dhanwant', 'Initials': 'D', 'LastName': 'Gomez', 'Affiliation': ""Department of Hepatobiliary and Pancreatic Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, England.""}]",JAMA surgery,['10.1001/jamasurg.2020.1998']
2493,32667635,Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy: The Randomized Clinical IPOD Trial.,"Importance


Although standardization of pancreaticoduodenectomy (PD) has improved postoperative outcomes, morbidity remains high. Fast-track surgery programs appear to improve morbidity, and avoiding nasogastric tube decompression (NGTD), already outdated in most major abdominal surgery, is strongly suggested after PD by fast-track surgery programs but lacks high-level evidence, especially regarding safety.
Objective


To assess in a randomized clinical trial whether the absence of systematic NGTD after PD reduces postoperative complications.
Design, Setting, and Participants


The IPOD study (Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy) was an open-label, prospective, single-center, randomized clinical trial conducted at a high-volume pancreatic surgery university hospital in France. In total, 155 patients who were 18 to 75 years of age and required PD for benign or malignant disease were screened for study eligibility. Key exclusion criteria were previous gastric or esophageal surgery and severe comorbidities. Patients were randomly assigned (1:1) to systematic NGTD or to no nasogastric decompression and were followed up until 90 days after surgery.
Interventions


For patients without NGTD, the NGT was removed immediately after surgery, whereas for patients with NGTD, the NGT was removed 3 to 5 days after surgery.
Main Outcomes and Measures


The primary end point was the occurrence of postoperative complications grade II or higher using the Clavien-Dindo classification. The primary end point and safety were evaluated in the intent-to-treat population.
Results


From January 2016 to August 2018, 125 screened patients were considered eligible for the study, and 111 were randomized to no NGTD (n = 52) or to NGTD (n = 59). No patient was lost to follow-up. The 2 groups had similar patient demographic and clinical characteristics at baseline. The median (interquartile range) age was 63.0 (57.0-66.5) years in the group with NGTD (38 [64.4%] were males) and 64.0 (58.0-68.0) years in the group without NGTD (31 [59.6%] were males). The postoperative complication rates grade II or higher were similar between the 2 groups (risk ratio, 0.99; 95% CI, 0.66-1.47; P > .99). Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups. Median (interquartile) length of hospital stay for patients without NGTD was not significantly different compared with those with NGTD (10.0 [9.0-16.3] vs 12.0 [10.0-16.0] days; P = .14).
Conclusions and Relevance


The present study found no significant difference in postoperative complication occurrence of Clavien-Dindo classification grade II or higher between systematic NGTD and no NGTD after PD, suggesting that avoiding systematic nasogastric decompression is safe for this indication.
Trial Registration


ClinicalTrials.gov Identifier: NCT02594956.",2020,"Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups.","['patients without NGTD', '155 patients who were 18 to 75 years of age and required PD for benign or malignant disease were screened for study eligibility', 'From January 2016 to August 2018, 125 screened patients were considered eligible for the study, and 111 were randomized to no NGTD (n\u2009=\u200952) or to NGTD (n\u2009=\u200959', 'high-volume pancreatic surgery university hospital in France', 'The median (interquartile range) age was 63.0 (57.0-66.5) years in the group with NGTD (38 [64.4%] were males) and 64.0 (58.0-68.0) years in the group without NGTD (31 [59.6%] were males']","['pancreaticoduodenectomy (PD', 'Nasogastric Decompression vs No Decompression', 'Nasogastric Decompression', 'systematic NGTD or to no nasogastric decompression', 'Fast-track surgery programs']","['Pulmonary complication rates', 'Median (interquartile) length of hospital stay', 'occurrence of postoperative complications grade II or higher using the Clavien-Dindo classification', 'delayed gastric emptying rates', 'postoperative complication rates grade II or higher']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}]",155.0,0.200993,"Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups.","[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bergeat', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Merdrignac', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Robin', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Gaignard', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rayar', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Beloeil', 'Affiliation': 'University of Rennes, Rennes, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Boudjema', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': 'University of Rennes, Rennes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Sulpice', 'Affiliation': 'Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France.'}]",JAMA surgery,['10.1001/jamasurg.2020.2291']
2494,32667636,Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia: A Randomized Clinical Trial.,"Importance


Long-acting injectable antipsychotics (LAIs) can potentially reduce hospitalization risk by enhancing medication adherence but are rarely considered for early-phase schizophrenia treatment.
Objective


To determine whether encouraging use of a LAI compared with usual care delays the time to first hospitalization with patients with early-phase illness.
Design, Setting, and Participants


The Prevention of Relapse in Schizophrenia (PRELAPSE) trial was cluster randomized with a follow-up duration of 2 years. The study began in December 2014, was completed in March 2019, and was conducted in 39 mental health centers in 19 US states. Site randomization assigned 19 clinics to encourage treatment with long-acting aripiprazole monohydrate (aripiprazole once monthly [AOM] condition) and 20 to provide treatment as usual (clinician's choice [CC] condition). Participant eligibility criteria included (1) schizophrenia diagnosis confirmed by a structured clinical interview, (2) fewer than 5 years of lifetime antipsychotic use, and (3) age 18 to 35 years. The AOM sites identified 576 potentially eligible participants, of whom 234 (40.6%) enrolled; CC sites identified 685 potentially eligible participants, of whom 255 (37.2%) enrolled.
Interventions


There were no restrictions on treatment at CC sites (including using LAIs) or at AOM sites with the exception that aripiprazole monohydrate had to be prescribed within US Food and Drug Administration-approved guidelines.
Main Outcomes and Measures


The primary outcome was time to first psychiatric hospitalization based on participant interviews every 2 months, the service use resource form administered every 4 months, and other sources (eg, health records) as available. Potential events were adjudicated by an independent committee masked to treatment assignment.
Results


The 489 participants (368 men [55.3%]) had a mean (SD) age of 25.2 (4.2) years and 225 (46.0%) had 1 year or less lifetime antipsychotic use. Fifty-two AOM (22%) and 91 CC participants (36%) had at least 1 hospitalization. The mean survival time until first hospitalization was 613.7 days (95% CI, 582.3-645.1 days) for AOM participants and 530.6 days (95% CI, 497.3-563.9 days) for CC participants. For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34- 0.92; P = .02), favoring AOM. Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants. The number needed to treat to prevent 1 additional hospitalization was 7 participants treated with AOM compared with CC.
Conclusions and Relevance


Long-acting injectable antipsychotic use by patients with early-phase schizophrenia can significantly delay time to hospitalization, a personally and economically important outcome. Clinicians should more broadly consider LAI treatment for patients with early-phase illness.
Trial Registration


ClinicalTrials.gov Identifier: NCT02360319.",2020,"Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants.","['489 participants (368 men [55.3%]) had a mean (SD) age of 25.2 (4.2) years and 225 (46.0%) had 1 year or less lifetime antipsychotic use', '576 potentially eligible participants, of whom 234 (40.6%) enrolled; CC sites identified 685 potentially eligible participants, of whom 255 (37.2%) enrolled', 'patients with early-phase illness', 'The study began in December 2014, was completed in March 2019, and was conducted in 39 mental health centers in 19 US states', 'Early-Phase Schizophrenia', 'Participant eligibility criteria included (1) schizophrenia diagnosis confirmed by a structured clinical interview, (2) fewer than 5 years of lifetime antipsychotic use, and (3) age 18 to 35 years', 'patients with early-phase schizophrenia']","['Long-Acting Injectable Antipsychotics vs Usual Care', 'aripiprazole monohydrate', 'aripiprazole monohydrate (aripiprazole', 'Importance\n\n\nLong-acting injectable antipsychotics (LAIs']","['mean survival time until first hospitalization', 'time to first psychiatric hospitalization based on participant interviews every 2 months, the service use resource form administered every 4 months, and other sources (eg, health records) as available', 'Survival probabilities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0205388', 'cui_str': 'Few'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0585338', 'cui_str': 'Every four months'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.152895,"Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'Departments of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Schooler', 'Affiliation': 'SUNY Downstate Health Sciences University, Brooklyn, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marcy', 'Affiliation': 'Vanguard Research Group, Glen Oaks, New York.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Departments of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Achtyes', 'Affiliation': 'Cherry Health, Grand Rapids, Michigan.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gibbons', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': 'Departments of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.2076']
2495,32667647,Randomized Clinical Trial of Nasogastric Tube Placement After Pancreaticoduodenectomy.,,2020,,[],['Nasogastric Tube Placement After Pancreaticoduodenectomy'],[],[],"[{'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]",[],,0.12009,,"[{'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Sharib', 'Affiliation': 'Division of General Surgery, Section of Surgical Oncology and Hepatopancreaticobiliary Surgery, Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Eric K', 'Initials': 'EK', 'LastName': 'Nakakura', 'Affiliation': 'Division of General Surgery, Section of Surgical Oncology and Hepatopancreaticobiliary Surgery, Department of Surgery, University of California, San Francisco.'}]",JAMA surgery,['10.1001/jamasurg.2020.2305']
2496,32667654,Effect of Rotigotine vs Placebo on Cognitive Functions Among Patients With Mild to Moderate Alzheimer Disease: A Randomized Clinical Trial.,"Importance


Impairment of dopaminergic transmission may contribute to cognitive dysfunction in Alzheimer disease (AD).
Objective


To investigate whether therapy with dopaminergic agonists may affect cognitive functions in patients with AD.
Design, Setting, and Participants


This phase 2, monocentric, randomized, double-blind, placebo-controlled trial was conducted in Italy. Patients with mild to moderate AD were enrolled between September 1, 2017, and December 31, 2018. Data were analyzed from July 1 to September 1, 2019.
Interventions


A rotigotine 2 mg transdermal patch for 1 week followed by a 4 mg patch for 23 weeks (n = 47) or a placebo transdermal patch for 24 weeks (n = 47).
Main Outcomes and Measures


The primary end point was change from baseline on the Alzheimer Disease Assessment Scale-Cognitive Subscale. Secondary end points were changes in Frontal Assessment Battery, Alzheimer Disease Cooperative Study-Activities of Daily Living, and Neuropsychiatric Inventory scores. Prefrontal cortex activity was evaluated by transcranial magnetic stimulation combined with electroencephalography.
Results


Among 94 patients randomized (mean [SD] age, 73.9 [5.6] years; 58 [62%] women), 78 (83%) completed the study. Rotigotine, as compared with placebo, had no significant effect on the primary end point: estimated mean change in Alzheimer Disease Assessment Scale-Cognitive Subscale score was 2.92 (95% CI, 2.51-3.33) for the rotigotine group and 2.66 (95% CI, 2.31-3.01) for the placebo group. For the secondary outcomes, there were significant estimated mean changes between groups for Alzheimer Disease Cooperative Study-Activities of Daily Living score (-3.32 [95% CI, -4.02 to -2.62] for rotigotine and -7.24 [95% CI, -7.84 to -6.64] for placebo) and Frontal Assessment Battery score (0.48 [95% CI, 0.31 to 0.65] for rotigotine and -0.66 [95% CI, -0.80 to -0.52] for placebo). There was no longitudinal change in Neuropsychiatric Inventory scores (1.64 [95% CI, 1.06-2.22] for rotigotine and 1.26 [95% CI, 0.77-1.75] for placebo group). Neurophysiological analysis of electroencephalography results indicated that prefrontal cortical activity increased in rotigotine but not in the placebo group. Adverse events were more common in the rotigotine group, with 11 patients dropping out compared with 5 in the placebo group.
Conclusions and Relevance


In this randomized clinical trial, rotigotine treatment did not significantly affect global cognition in patients with mild to moderate AD; however, improvement was observed in cognitive functions highly associated with the frontal lobe and in activities of daily living. These findings suggest that treatment with the dopaminergic agonist rotigotine may reduce symptoms associated with frontal lobe cognitive dysfunction and thus may delay the impairment of activities of daily living.
Trial Registration


ClinicalTrials.gov Identifier: NCT03250741.",2020,"For the secondary outcomes, there were significant estimated mean changes between groups for Alzheimer Disease Cooperative Study-Activities of Daily Living score (-3.32 [95% CI, -4.02 to -2.62] for rotigotine and -7.24","['patients with AD', 'Patients with mild to moderate AD were enrolled between September 1, 2017, and December 31, 2018', 'patients with mild to moderate AD', '94 patients randomized (mean [SD] age, 73.9 [5.6] years; 58 [62%] women), 78 (83%) completed the study', 'Patients With Mild to Moderate Alzheimer Disease', 'Alzheimer disease (AD']","['dopaminergic agonist rotigotine', 'placebo transdermal patch', 'rotigotine 2 mg transdermal patch', 'Rotigotine vs Placebo', 'Rotigotine', 'rotigotine', 'transcranial magnetic stimulation combined with electroencephalography', 'placebo']","['Adverse events', 'mean change in Alzheimer Disease Assessment Scale-Cognitive Subscale score', 'Neuropsychiatric Inventory scores', 'Prefrontal cortex activity', 'Cognitive Functions', 'Alzheimer Disease Cooperative Study-Activities of Daily Living score', 'global cognition', 'cognitive functions', 'prefrontal cortical activity', 'Alzheimer Disease Assessment Scale-Cognitive Subscale', 'Frontal Assessment Battery score', 'changes in Frontal Assessment Battery, Alzheimer Disease Cooperative Study-Activities of Daily Living, and Neuropsychiatric Inventory scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C2960460', 'cui_str': 'Frontal assessment battery score'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}]",94.0,0.720977,"For the secondary outcomes, there were significant estimated mean changes between groups for Alzheimer Disease Cooperative Study-Activities of Daily Living score (-3.32 [95% CI, -4.02 to -2.62] for rotigotine and -7.24","[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Motta', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bonnì', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Maria Concetta', 'Initials': 'MC', 'LastName': 'Pellicciari', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Picazio', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Elias Paolo', 'Initials': 'EP', 'LastName': 'Casula', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maiella', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Lorenzo', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Ponzo', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Ferrari', 'Affiliation': 'Unit of Statistics, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Scaricamazza', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Martorana', 'Affiliation': 'Department of Behavioral and Clinical Neurology, Santa Lucia Foundation Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.10372']
2497,32667750,CORR Insights®: No Difference in Pain After Spine Surgery with Local Wound Filtration of Morphine and Ketorolac: A Randomized Controlled Trial.,,2020,,[],"['Morphine and Ketorolac', 'CORR Insights®']",['Pain'],[],"[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0233820', 'cui_str': 'Insight'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.281255,,"[{'ForeName': 'Jacques T', 'Initials': 'JT', 'LastName': 'YaDeau', 'Affiliation': 'J. T. YaDeau, Department of Anesthesiology, Hospital for Special Surgery, New York, NY, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001407']
2498,32664827,Cilostazol versus aspirin in ischemic stroke with cerebral microbleeds versus prior intracerebral hemorrhage.,"BACKGROUND


In PreventIon of CArdiovascular Events in Ischaemic Stroke Patients with High Risk of Cerebral HaemOrrhage (PICASSO), cilostazol versus aspirin was comparable for the end points of cerebral hemorrhage and major vascular events. However, underlying hemorrhage-prone lesions could modify the treatment effect.
AIMS


We explored whether the safety and efficacy of cilostazol versus aspirin would differ between hemorrhage-prone lesions (multiple cerebral microbleeds vs. prior intracerebral hemorrhage).
METHODS


In this post hoc analysis of PICASSO, we divided patients into the cerebral microbleeds and prior intracerebral hemorrhage subgroups. The primary safety end point was the first occurrence of cerebral hemorrhage. The primary efficacy end point was the composite of stroke, myocardial infarction, or vascular death.
RESULTS


Of 1512 patients, 903 (59.7%) had multiple cerebral microbleeds and 609 (40.3%) had prior intracerebral hemorrhage. The cerebral hemorrhage risk was lower with cilostazol versus aspirin (0.12%/year vs. 1.49%/year; hazard ratio, 0.08 [95% confidence interval 0.01-0.60];  p  = 0.015) in the cerebral microbleeds subgroup, but was not different (1.26%/year vs. 0.79%/year; hazards ratio 1.60 [0.52-4.90];  p  = 0.408) in the prior intracerebral hemorrhage subgroup. The interaction of treatment-by-subgroup was significant ( p interaction  = 0.011). For the composite of major vascular events, there was a trend toward a lower risk with cilostazol versus aspirin (3.56%/year vs. 5.53%/year; hazards ratio 0.64 [0.41-1.01];  p  = 0.056) in the cerebral microbleeds subgroup, but was comparable (5.21%/year vs. 5.05%/year; hazards ratio 1.03 [0.63-1.67];  p  = 0.913) in the prior intracerebral hemorrhage subgroup without a significant treatment-by-subgroup interaction ( p interaction  = 0.165).
CONCLUSIONS


Cilostazol versus aspirin might be a better option in ischemic stroke with multiple cerebral microbleeds, but confirmatory trials are needed.
CLINICAL TRIAL REGISTRATION


URL:http://www.clinicaltrials.gov. NCT01013532.",2020,"The cerebral hemorrhage risk was lower with cilostazol versus aspirin (0.12%/year vs. 1.49%/year; hazard ratio, 0.08","['Ischaemic Stroke Patients with High Risk of Cerebral HaemOrrhage (PICASSO', 'ischemic stroke with cerebral microbleeds versus prior intracerebral hemorrhage', 'divided patients into the cerebral microbleeds and prior intracerebral hemorrhage subgroups', 'Of 1512 patients, 903 (59.7%) had multiple cerebral microbleeds and 609 (40.3%) had prior intracerebral hemorrhage', 'hemorrhage-prone lesions (multiple cerebral microbleeds vs. prior intracerebral hemorrhage']","['cilostazol versus aspirin', 'Cilostazol versus aspirin']","['cerebral hemorrhage risk', 'safety and efficacy', 'cerebral hemorrhage', 'composite of stroke, myocardial infarction, or vascular death']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1512.0,0.134688,"The cerebral hemorrhage risk was lower with cilostazol versus aspirin (0.12%/year vs. 1.49%/year; hazard ratio, 0.08","[{'ForeName': 'Hong-Kyun', 'Initials': 'HK', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Korea.'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Bum Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Kyung Hee University Medical Center, Seoul, Korea.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Myungji Hospital, Hanyang University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': ""Department of Neurology, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Anam Hospital, Korea University, Seoul, Korea.'}, {'ForeName': 'Yang-Ha', 'Initials': 'YH', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurology, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Joung-Ho', 'Initials': 'JH', 'LastName': 'Rha', 'Affiliation': 'Department of Neurology, Inha University Hospital, Incheon, Korea.'}, {'ForeName': 'Sung Hyuk', 'Initials': 'SH', 'LastName': 'Heo', 'Affiliation': 'Department of Neurology, Kyung Hee University Medical Center, Seoul, Korea.'}, {'ForeName': 'Seong Hwan', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Chosun University School of Medicine and Hospital, Gwangju, Korea.'}, {'ForeName': 'Woo-Keun', 'Initials': 'WK', 'LastName': 'Seo', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sunkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Jong-Moo', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Nowon Eulji Medical Center, Eulji University, Seoul, Korea.'}, {'ForeName': 'Ju-Hun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Kangdong Sacred Heart Hospital, Hallym University, Seoul, Korea.'}, {'ForeName': 'Jee-Hyun', 'Initials': 'JH', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Ulsan University Hospital, Ulsan University, Ulsan, Korea.'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Dongsan Medical Center, Keimyung University, Daegu, Korea.'}, {'ForeName': 'Jin-Man', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Ansan Hospital, Korea University, Seoul, Korea.'}, {'ForeName': 'Sun U', 'Initials': 'SU', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Asan Medical Center, Ulsan University, Seoul, Korea.'}, {'ForeName': 'Keun-Sik', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020941273']
2499,32658503,The impact of neurofeedback training on children with developmental trauma: A randomized controlled study.,"OBJECTIVE


Developmental trauma or chronic early childhood exposure to abuse and neglect by caregivers has been shown to have a long-lasting pervasive impact on mental and neural development, including problems with attention, impulse control, self-regulation, and executive functioning. Its long-term effects are arguably the costliest public health challenge in the United States. Children with developmental trauma rarely have a satisfactory response to currently available evidence-based psychotherapeutic and pharmacological treatments. Neurofeedback training (NFT) is a clinical application of brain computer interface technology, aiming to alter electrical brain activity associated with various mental dysfunctions. NFT has shown promise to improve posttraumatic stress disorder (PTSD) symptoms.
METHOD


This randomized controlled study examined the effects of NFT on 37 children, aged 6-13 years with developmental trauma. Participants were randomly divided into active NFT ( n  = 20) or treatment-as-usual control ( n  = 17). Both groups underwent 4 assessments during equivalent timelines. The active group received 24 NFT sessions twice a week.
RESULTS


This pilot study demonstrated that 24 sessions of NFT significantly decreased PTSD symptoms, internalizing, externalizing, other behavioral and emotional symptoms, and significantly improved the executive functioning of children aged 6-13 years with severe histories of abuse and neglect who had not significantly benefited from any previous therapy.
CONCLUSIONS


NFT offers the possibility to improve learning, enhance self-efficacy, and develop better social relationships in this hitherto largely treatment-resistant population. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"This pilot study demonstrated that 24 sessions of NFT significantly decreased PTSD symptoms, internalizing, externalizing, other behavioral and emotional symptoms, and significantly improved the executive functioning of children aged 6-13 years with severe histories of abuse and neglect who had not significantly benefited from any previous therapy.
","['37 children, aged 6-13 years with developmental trauma', 'children with developmental trauma', 'Children with developmental trauma']","['active NFT', 'NFT', 'neurofeedback training', 'NFT sessions twice a week', 'Neurofeedback training (NFT']","['executive functioning', 'PTSD symptoms, internalizing, externalizing, other behavioral and emotional symptoms', 'learning, enhance self-efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",37.0,0.0242102,"This pilot study demonstrated that 24 sessions of NFT significantly decreased PTSD symptoms, internalizing, externalizing, other behavioral and emotional symptoms, and significantly improved the executive functioning of children aged 6-13 years with severe histories of abuse and neglect who had not significantly benefited from any previous therapy.
","[{'ForeName': 'Ainat', 'Initials': 'A', 'LastName': 'Rogel', 'Affiliation': 'The Trauma Center.'}, {'ForeName': 'Alysse M', 'Initials': 'AM', 'LastName': 'Loomis', 'Affiliation': 'College of Social Work, University of Utah.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Hamlin', 'Affiliation': 'Department of Psychiatry, University of North Carolina School of Medicine.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Hodgdon', 'Affiliation': 'Trauma Center at Justice Resource Institute.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Spinazzola', 'Affiliation': 'The Foundation Trust.'}, {'ForeName': 'Bessel', 'Initials': 'B', 'LastName': 'van der Kolk', 'Affiliation': 'Trauma Research Foundation.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000648']
2500,32658515,Effects of an adolescent depression prevention program on maternal criticisms and positive remarks.,"This study examined effects of an adolescent depression prevention program on maternal criticisms and positive remarks, whether the extent of adolescents' depression accounted for effects, and whether effects of the program on maternal criticisms and positive remarks differed by adolescents' gender. Participants were 298 adolescent ( M age  = 14.79,  SD  = 1.36; 59% female) offspring of mothers with histories of depression; youth were randomized to either a cognitive-behavioral prevention (CBP) program or usual care (UC). At baseline and 9-month postintervention evaluations, mothers were administered the Five-Minute Speech Sample to measure number of criticisms and positive remarks made during an open-ended description of their child and their relationship. Adolescents' depression from pre- through postintervention was assessed with interviews. A hierarchical generalized linear model showed a significant condition-by-gender interaction, indicating that, controlling for baseline criticism, at postintervention mothers of girls in CBP made significantly more criticisms than did mothers of girls in UC, whereas mothers of boys in CBP made fewer criticisms than did mothers of boys in UC. The extent of adolescents' depression from pre- through postintervention partially mediated the relation between intervention condition and mothers' criticisms, for boys but not for girls. Second, controlling for preintervention positive remarks, at postintervention, mothers of youth in CBP made significantly more positive remarks about their child than did mothers of youth in UC, regardless of gender; this relation was not mediated by adolescent depression from pre- through postintervention. We suggest possible explanations for the observed effects of CBP on mothers' criticisms and positive remarks. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The extent of adolescents' depression from pre- through postintervention partially mediated the relation between intervention condition and mothers' criticisms, for boys but not for girls.","['Participants were 298 adolescent ( M age  = 14.79,  SD  = 1.36; 59% female) offspring of mothers with histories of depression; youth']","['CBP', 'adolescent depression prevention program', 'cognitive-behavioral prevention (CBP) program or usual care (UC']","['maternal criticisms and positive remarks', 'positive remarks']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708912', 'cui_str': '1.36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0301039', 'cui_str': '1-chloro-3-bromopropene-1'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",298.0,0.0939196,"The extent of adolescents' depression from pre- through postintervention partially mediated the relation between intervention condition and mothers' criticisms, for boys but not for girls.","[{'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Nestor', 'Affiliation': 'Department of Psychology and Human Development, Peabody College, Vanderbilt University.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Sutherland', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University.'}, {'ForeName': 'Chrystyna D', 'Initials': 'CD', 'LastName': 'Kouros', 'Affiliation': 'Department of Psychology, Southern Methodist University.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Brunwasser', 'Affiliation': 'Department of Psychology, Rowan University.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': 'Department of Psychology, Vanderbilt University.'}, {'ForeName': 'V Robin', 'Initials': 'VR', 'LastName': 'Weersing', 'Affiliation': 'Department of Psychology, San Diego State University.'}, {'ForeName': 'Tracy R G', 'Initials': 'TRG', 'LastName': 'Gladstone', 'Affiliation': 'Wellesley Centers for Women, Wellesley College.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Center for Health Research.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Beardslee', 'Affiliation': 'Department of Psychiatry, Harvard Graduate School of Education.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brent', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Garber', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000779']
2501,32658516,Trust in expert versus lay comments in online articles about spanking and car seat safety.,"In this study, we experimentally examined parents' perceptions of scientific information about spanking, a controversial topic, and car seat safety, a consensus topic, presented in online news articles. Specifically, we tested whether parents of children ages 2 to 8 years would trust scientific experts (speaking from professional expertise) more than online lay commenters (speaking from personal experience). One hundred and eighty parents across 41 U.S. states were recruited online from Amazon's Mechanical Turk (124 mothers, 56 fathers; 74% White, 9% Black, 8% Latino, 8% Asian, and 1% other or multiple ethnicities). Parents were randomly assigned to read a news article with an expert discussing spanking research that varied by two conditions: The news article contained either anti-spanking lay comments or pro-spanking lay comments. All parents also read a second news article on car seat safety (a consensus topic). Between-condition analyses were used to compare perceptions of the comment conditions, and within-condition analyses were used to compare perceptions of the expert knowledge versus the comments and to compare perceptions of the spanking expert versus the car seat expert. Moderation analyses were used to compare parents' perceptions based on their attitudes toward spanking. Parents with positive attitudes toward spanking recognized pro-spanking comments as opinion, yet still found them more trustworthy than a scientist taking the opposite position. All parents perceived the car seat expert as trustworthy. The results highlight challenges in disseminating information about controversial topics to the public. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Parents with positive attitudes toward spanking recognized pro-spanking comments as opinion, yet still found them more trustworthy than a scientist taking the opposite position.","[""One hundred and eighty parents across 41 U.S. states were recruited online from Amazon's Mechanical Turk (124 mothers, 56 fathers; 74% White, 9% Black, 8% Latino, 8% Asian, and 1% other or multiple ethnicities"", 'parents of children ages 2 to 8 years would trust scientific experts (speaking from professional expertise) more than online lay commenters (speaking from personal experience']",['news article contained either anti-spanking lay comments or pro-spanking lay comments'],[],"[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",[],,0.0253666,"Parents with positive attitudes toward spanking recognized pro-spanking comments as opinion, yet still found them more trustworthy than a scientist taking the opposite position.","[{'ForeName': 'Justin K', 'Initials': 'JK', 'LastName': 'Scott', 'Affiliation': 'Department of Human Development and Family Sciences, The University of Texas at Austin.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Gershoff', 'Affiliation': 'Department of Human Development and Family Sciences, The University of Texas at Austin.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000784']
2502,32658536,Both reducing cigarettes per day and transitioning to very low-nicotine-content cigarettes decreases demand for usual-brand cigarettes.,"Reducing cigarettes per day (CPD) and transitioning to very low-nicotine-content (VLNC) cigarettes appear to decrease nicotine dependence. Other well-accepted measures of the addictiveness of cigarettes involve behavioral economic simulation models, such as the cigarette purchase task (CPT), which characterizes the reinforcing efficacy of cigarettes. Currently it is unclear whether reducing CPD or reducing nicotine through VLNC cigarettes leads to greater reductions in the reinforcing efficacy of cigarettes. The current paper reports a secondary analysis of a 5-week, 2-arm unblinded randomized trial, in which participants were instructed to gradually reduce to 70%, 35%, 15%, and 3% of baseline nicotine over 4 weeks by either (a) reducing CPD (n = 32) or (b) switching to VLNC cigarettes (n = 36). Participants completed the CPT for their usual-brand cigarettes at baseline and again at a 1-month follow-up. Demand was significantly reduced for participants' usual-brand cigarettes in both the CPD, t(18) = 7.65, p < .0001, and the VLNC groups, t(18) = 7.39, p < .0001, from prereduction procedure to the 1-month follow-up. Maximum consumption at zero price (intensity), and maximum expenditure (Omax), were reduced significantly for both the CPD group, t(16) = 3.23, p = .005; t(16) = 3.71, p = .002, respectively, and the VLNC group, t(22) = 3.62, p = .002; t(22) = 3.14, p = .005, respectively, prereduction procedure to the 1-month follow-up. Thus, despite the different mechanisms by which the value of cigarettes was manipulated, both interventions reduced the reinforcing efficacy of cigarettes. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Demand was significantly reduced for participants' usual-brand cigarettes in both the CPD, t(18) = 7.65, p < .0001, and the VLNC groups, t(18) =",[],"['VLNC cigarettes', 'CPT']","['Maximum consumption at zero price (intensity), and maximum expenditure (Omax', 'nicotine dependence']",[],"[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}]",,0.0261304,"Demand was significantly reduced for participants' usual-brand cigarettes in both the CPD, t(18) = 7.65, p < .0001, and the VLNC groups, t(18) =","[{'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Nighbor', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Elias M', 'Initials': 'EM', 'LastName': 'Klemperer', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Ellaina N', 'Initials': 'EN', 'LastName': 'Reed', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Simone', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Vermont Center on Behavior and Health.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000403']
2503,32658597,A Novel Assessment Technique Does Not Produce More Reliable Estimates of Maximal Neuromuscular Strength.,"Accurate determinations of individuals' one-repetition maximum (1RM) are critical when evaluating the effectiveness of an exercise intervention involving progressive resistance training (RT). Traditional (""bottom-up""; BT) testing methods involve progressions from low to maximal loads and are commonly used in clinical and laboratory environments. Concerns about the reliability of BT testing in certain populations suggest a different technique may be more effective.  Purpose : To compare the reliability and effectiveness of traditional 1RM testing to a novel technique (TDT) involving progressive load reductions and a starting intensity equal to 130% of exercisers' estimated 1RM.  Method : 70 healthy adults (age = 45.03 ± 25.64 y) with diverse RT experience were randomized into a reliability testing trial (RTT; n = 33) or an optimal method trial (OMT; n = 37). Subjects in the RTT performed either TDT or BT on 3 occasions separated by ≥ 72 hours, while subjects in the OMT performed each method once in random order on separate days.  Results : No significant differences in percent coefficient of variation were observed between BT and TDT for either exercise used in the study (pneumatic seated chest press: Hedge's  g  = 0.25,  p  = .49; pneumatic recumbent leg press: Hedge's  g  = 0.12,  p  = .74). TDT was not found to produce significantly higher 1RM values than BT in any group.  Conclusion : TDT does not appear to facilitate more reliable 1RM estimates than BT. Further research is needed to determine the stability of these findings across levels of exercisers' age, sex, and previous RT experience.",2020,"No significant differences in percent coefficient of variation were observed between BT and TDT for either exercise used in the study (pneumatic seated chest press: Hedge's  g  = 0.25,  ",['Method : 70 healthy adults (age\xa0=\xa045.03\xa0±\xa025.64 y) with diverse RT experience'],"['TDT or BT', 'traditional 1RM testing to a novel technique (TDT', 'TDT', 'exercise intervention involving progressive resistance training (RT']",['1RM values'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}]",70.0,0.0254463,"No significant differences in percent coefficient of variation were observed between BT and TDT for either exercise used in the study (pneumatic seated chest press: Hedge's  g  = 0.25,  ","[{'ForeName': 'Andrew N L', 'Initials': 'ANL', 'LastName': 'Buskard', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Kirk B', 'Initials': 'KB', 'LastName': 'Roberson', 'Affiliation': 'Stetson University.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Signorile', 'Affiliation': 'University of Miami.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1761935']
2504,32658610,Correction to: Results of the FUEL Trial.,,2020,,[],[],[],[],[],[],,0.0268756,,[],Circulation,['10.1161/CIR.0000000000000882']
2505,32658754,Comparison of two Anti Snake Venom protocols in hemotoxic snake bite: A randomized trial.,"The dose of Anti Snake Venom (ASV) in hemotoxic snake bite depends on the amount of venom injected and species of snake. All trials in South East Asia have studied different doses of ASV, wherein the ASV in high dose group itself was lower than the dose that is recommended in Indian National protocol. These studies favored low dose protocol, as there was no difference in mortality and morbidity between the groups. So, this study intended to assess the efficacy of National protocol in reducing morbidity and mortality in hemotoxic snake bite in comparison to current protocol followed in institution. This was an open label randomized trial of 140 hemotoxic snakebite patients. Group A received national protocol: initial dose of 100 ml followed by 100 ml 6th hourly till 20-min Whole Blood Clotting Time (20WBCT) was negative or 300 ml of ASV was given, whichever was earlier. Group B received 70 ml followed by 30 ml every 6th hourly until two consecutive 20WBCT were negative. There was no statistical difference in the amount of ASV required in both the groups. Mortality and acute kidney injury were higher in group A (statistically not significant), probably due to sicker patients in that group. There was no relapse of clotting time abnormality in both the groups. In a significant number of patients (12%), clotting time was persistently prolonged till death. We found that the use of National ASV dosing protocol did not decrease the mortality and morbidity.",2020,"Mortality and acute kidney injury were higher in group A (statistically not significant), probably due to sicker patients in that group.","['hemotoxic snake bite', '140 hemotoxic snakebite patients']","['Anti Snake Venom (ASV', 'national protocol: initial dose of 100\xa0ml followed by 100\xa0ml 6th hourly till 20-min Whole Blood Clotting Time (20WBCT) was negative or 300\xa0ml of ASV']","['relapse of clotting time abnormality', 'Mortality and acute kidney injury', 'mortality and morbidity', 'clotting time']","[{'cui': 'C0037379', 'cui_str': 'Poisoning by venomous snake'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037380', 'cui_str': 'Snake venom'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0043159', 'cui_str': 'Coagulation time, Lee White'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0368930', 'cui_str': 'Coagulation time'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",140.0,0.0472173,"Mortality and acute kidney injury were higher in group A (statistically not significant), probably due to sicker patients in that group.","[{'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Sagar', 'Affiliation': 'Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Chanaveerappa', 'Initials': 'C', 'LastName': 'Bammigatti', 'Affiliation': 'Jawaharlal institute of postgraduate medical education and research, Puducherry, India. Electronic address: bammigatti@yahoo.com.'}, {'ForeName': 'Tamilarasu', 'Initials': 'T', 'LastName': 'Kadhiravan', 'Affiliation': 'Jawaharlal institute of postgraduate medical education and research, Puducherry, India.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Harichandrakumar', 'Affiliation': 'Jawaharlal institute of postgraduate medical education and research, Puducherry, India.'}, {'ForeName': 'Rathinam Palamalai', 'Initials': 'RP', 'LastName': 'Swaminathan', 'Affiliation': 'Jawaharlal institute of postgraduate medical education and research, Puducherry, India.'}, {'ForeName': 'Mahendra M', 'Initials': 'MM', 'LastName': 'Reddy', 'Affiliation': 'Sri Devaraj Urs Medical College (SDUMC), Sri Devaraj Urs Academy of Higher Education and Research (SDUAHER), Kolar, Karnataka, India.'}]",Journal of forensic and legal medicine,['10.1016/j.jflm.2020.101996']
2506,32658830,The feasibility of acupuncture as an adjunct intervention for antenatal depression: a pragmatic randomised controlled trial.,"BACKGROUND


Antenatal depression is common and associated with adverse consequences for mothers, babies, and future generations. Limitations with conventional approaches has resulted in additional therapies being considered. This study examined the feasibility and effectiveness of acupuncture for improving mental health.
METHODS


Fifty-seven pregnant women with depressive symptomologies were randomised to acupuncture (n=19) plus treatment as usual (TAU), progressive muscle relaxation (PMR, n=19) plus TAU or TAU (n=19). Treatments were conducted from 24 to 31 weeks gestation. Clinical assessments were performed throughout the intervention, as well as at a six-week postnatal follow-up. The primary outcome measure was depression. Secondary outcome measurements were stress, anxiety, psychological distress, quality of life and adjustment to mothering. Intention to treat (ITT), Linear Mixed Model (LMM) repeated measures and per protocol (PP) analyses were conducted.
RESULTS


At end-of-intervention there were significantly lower depression scores in the acupuncture group versus TAU and PMR respectively [ITT p<0.001, mean difference (MD) -5.84 (95% CI -9.10 to -2.58); MD -3.42 (95% CI -6.64 to -0.20)]. LMM repeated measures analysis (including postnatal follow-up) also demonstrated significantly lowered acupuncture group scores for stress (p=0.006) and psychological distress (p<0.001) when compared to PMR and TAU. Between group differences were not significant at six-weeks postnatal. No adverse events were reported.
LIMITATIONS


Main limitations are small sample size and the use of self-reported outcome measures.
CONCLUSION


Prenatal acupuncture reduced depression, stress and distress, whilst also being well-tolerated and free from adverse events. Further research is warranted.",2020,"At end-of-intervention there were significantly lower depression scores in the acupuncture group versus TAU and PMR respectively [ITT p<0.001, mean difference (MD)","['Fifty-seven pregnant women with depressive symptomologies', 'antenatal depression']","['acupuncture', 'acupuncture (n=19) plus treatment as usual (TAU), progressive muscle relaxation (PMR, n=19) plus TAU or TAU']","['mean difference (MD', 'depression scores', 'depression', 'adverse events', 'depression, stress and distress, whilst also being well-tolerated and free from adverse events', 'psychological distress', 'stress, anxiety, psychological distress, quality of life and adjustment to mothering']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0032533', 'cui_str': 'Polymyalgia rheumatica'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",57.0,0.185105,"At end-of-intervention there were significantly lower depression scores in the acupuncture group versus TAU and PMR respectively [ITT p<0.001, mean difference (MD)","[{'ForeName': 'Simone M', 'Initials': 'SM', 'LastName': 'Ormsby', 'Affiliation': 'Adjunct Fellow, NICM Health Research Institute, Level 1, Building J, Western Sydney University, Westmead Campus, Locked Bag 1797, Penrith, NSW 2751, Australia. Electronic address: simone.ormsby@westernsydney.edu.au.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'Professor of Clinical Research, NICM Health Research Institute, Level 1, Building J, Western Sydney University, Westmead Campus, Locked Bag 1797, Penrith, NSW, 2751, Australia. Electronic address: caroline.smith@westernsydney.edu.au.edu.au.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Dahlen', 'Affiliation': 'Professor of Midwifery, Associate Dean Research and HDR, Midwifery Discipline, Building EB, UWS Parramatta Campus, Locked Bag 1797, Penrith, NSW 2751, Australia. Electronic address: H.Dahlen@westernsydney.edu.au.'}, {'ForeName': 'Phillipa J', 'Initials': 'PJ', 'LastName': 'Hay', 'Affiliation': 'Professor of Mental Health, Translational Health Research Institute, School of Medicine Western Sydney University and Camden and Campbelltown Hospitals SWSLHD, Locked Bag 1797, Penrith, NSW 2751, Australia. Electronic address: P.Hay@westernsydney.edu.au.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.089']
2507,32658939,Minimal transmission in an influenza A (H3N2) human challenge-transmission model within a controlled exposure environment.,"Uncertainty about the importance of influenza transmission by airborne droplet nuclei generates controversy for infection control. Human challenge-transmission studies have been supported as the most promising approach to fill this knowledge gap. Healthy, seronegative volunteer 'Donors' (n = 52) were randomly selected for intranasal challenge with influenza A/Wisconsin/67/2005 (H3N2). 'Recipients' randomized to Intervention (IR, n = 40) or Control (CR, n = 35) groups were exposed to Donors for four days. IRs wore face shields and hand sanitized frequently to limit large droplet and contact transmission. One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure. The main difference between these studies was mechanical building ventilation in the follow-on study, suggesting a possible role for aerosols.",2020,"One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure.","[""Healthy, seronegative volunteer 'Donors' (n = 52""]",['intranasal challenge with influenza A/Wisconsin/67/2005 (H3N2). '],[],"[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}]",[],52.0,0.0134321,"One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure.","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Nguyen-Van-Tam', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Killingley', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enstone', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hewitt', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Jovan', 'Initials': 'J', 'LastName': 'Pantelic', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Grantham', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'P Jacob', 'Initials': 'PJ', 'LastName': 'Bueno de Mesquita', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lambkin-Williams', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gilbert', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mann', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Forni', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Noakes', 'Affiliation': 'University of Leeds School of Civil Engineering, Leeds, United Kingdom.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'LaShondra', 'Initials': 'L', 'LastName': 'Berman', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lindstrom', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cauchemez', 'Affiliation': 'Imperial College London, MRC Centre for Outbreak Analysis and Modelling, Department of Infectious Disease Epidemiology, London, United Kingdom.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Bischoff', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tellier', 'Affiliation': 'McGill University, Dept of Medicine, Montreal, Canada.'}, {'ForeName': 'Donald K', 'Initials': 'DK', 'LastName': 'Milton', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS pathogens,['10.1371/journal.ppat.1008704']
2508,32659032,Impact of end-expiratory pressure fluctuation on tidal volume in the trilevel positive airway pressure mode.,"INTRODUCTION


In noninvasive positive-pressure ventilation (NPPV), the changes in the expiratory positive airway pressure (EPAP) directly affect the magnitude of the tidal volume.
OBJECTIVES


this experimental study aims to verify the precise effects of end-expiratory fluctuation on the body tidal volume to better assist NPPV in clinical practice.
METHODS


We selected the TestChest®-simulated lung simulation of different populations, including healthy subjects (normal group), patients with chronic obstructive pulmonary disease (COPD) with emphysema as their primary phenotype (COPD1 group), and patients with COPD with bronchitis as their primary phenotype (COPD2 group).
RESULTS


Regarding the tidal volume curves of the three groups under various conditions, six-fold charts revealed that the tidal volume changed with the end-expiratory pressure fluctuations. In addition, regression coefficients for end-expiratory pressure fluctuations, (IPAP － EPAP) and (IPAP － EEPAP), showed exhibited a significant contribution to the tidal volume. The two coefficients in the normal, COPD1, and COPD2 groups were 52.294 and 10.414, 46.192 and -8.816, and 11.922 and 17.947, respectively. The circuit simulation results showed that the simulation curve fitted the experimental curve better by changing the coefficient of the descending edge of the expiratory phase.
CONCLUSIONS


The study results suggest that the end-expiratory pressure fluctuation affects the body tidal volume. Compared with the bilevel positive airway pressure (PAP), the trilevel PAP provides additional respiratory support to the body during a respiratory difference in initial respiration and descent.",2020,"The two coefficients in the normal, COPD1, and COPD2 groups were 52.294 and 10.414, 46.192 and -8.816, and 11.922 and 17.947, respectively.","['healthy subjects (normal group), patients with chronic obstructive pulmonary disease (COPD) with emphysema as their primary phenotype (COPD1 group), and patients with COPD with bronchitis as their primary phenotype (COPD2 group']","['end-expiratory pressure fluctuation', 'noninvasive positive-pressure ventilation (NPPV', 'bilevel positive airway pressure (PAP']","['body tidal volume', 'expiratory positive airway pressure (EPAP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C3164735', 'cui_str': 'Noninvasive positive pressure ventilation'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}]",,0.0255494,"The two coefficients in the normal, COPD1, and COPD2 groups were 52.294 and 10.414, 46.192 and -8.816, and 11.922 and 17.947, respectively.","[{'ForeName': 'Zhi-Xiang', 'Initials': 'ZX', 'LastName': 'Ma', 'Affiliation': 'Biomedical Engineering Institute, School of Control Science and Engineering, Shandong University, Jinan, 250061, China.'}, {'ForeName': 'Tian-Ran', 'Initials': 'TR', 'LastName': 'Zhou', 'Affiliation': 'Biomedical Engineering Institute, School of Control Science and Engineering, Shandong University, Jinan, 250061, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Biomedical Engineering Institute, School of Control Science and Engineering, Shandong University, Jinan, 250061, China.'}, {'ForeName': 'De-Dong', 'Initials': 'DD', 'LastName': 'Ma', 'Affiliation': 'Department of Respiratory Medicine, Qilu Hospital, Shandong University, No. 107, Wenhua Xi Road, Jinan, Shandong, 250012, China.'}]",The clinical respiratory journal,['10.1111/crj.13233']
2509,32659054,Auditory attentional biases in young males with physical stature dissatisfaction.,"The attentional biases toward body-related information for individuals with weight concerns and eating disorders have been well documented. However, our knowledge of the attentional biases toward body-related information for subjects with physical stature concerns is only at the beginning. And the research on the auditory attentional biases for individuals with physical stature concerns is rare. The identification of attentional biases may provide an impetus for interventions to reduce distress among height dissatisfied individuals. Therefore, the present study investigated the neural mechanisms of attentional bias toward auditory physical stature-related words among height dissatisfied young males by using event-related potential recordings. Forty-four young male participants screened by Negative Physical Self Scale-Stature Concerns subscale (NPS-S) were assigned into an experimental group with high levels of height dissatisfaction (HHD) and a control group with low levels of height dissatisfaction (LHD). Task irrelevant auditory tall-related words, short-related words and neutral words were presented unilaterally to the participants as the cue in a cue-target paradigm. Participants were required to respond to the visual target preceded by the task-irrelevant auditory cue. The results found that significantly larger N2ac was elicited by tall-related words than short-related words and neutral words only for the HHD group, but not for the LHD group. LPCpc amplitudes did not differ significantly by the functions of word types and experimental groups. These results suggest an attentional orienting bias toward auditory tall-related words for young males with high levels of height dissatisfaction.",2020,LPCpc amplitudes did not differ significantly by the functions of word types and experimental groups.,"['young males with high levels of height dissatisfaction', 'Forty-four young male participants screened by', 'individuals with weight concerns and eating disorders', 'young males with physical stature dissatisfaction', 'individuals with physical stature concerns']","['Task irrelevant auditory tall-related words, short-related words and neutral words were presented unilaterally to the participants as the cue in a cue-target paradigm', 'control group with low levels of height dissatisfaction (LHD']","['Auditory attentional biases', 'LPCpc amplitudes', 'auditory attentional biases', 'Negative Physical Self Scale-Stature Concerns subscale (NPS-S', 'attentional orienting bias toward auditory tall-related words']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",44.0,0.0111513,LPCpc amplitudes did not differ significantly by the functions of word types and experimental groups.,"[{'ForeName': 'Wenguan', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Psychology, School of Education, SooChow University, Suzhou, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""School of Educational Science, Huaiyin Normal University, Huai'an, China.""}, {'ForeName': 'Tingji', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology, School of Education, SooChow University, Suzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychology, School of Education, SooChow University, Suzhou, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Department of Psychology, School of Education, SooChow University, Suzhou, China.'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Psychology, School of Education, SooChow University, Suzhou, China.'}]",Psychophysiology,['10.1111/psyp.13635']
2510,32659313,"Long-Term, Open-Label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-Year Results.","BACKGROUND


We previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT™) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250μg) in a 12-month randomized controlled study (PEPITES) of peanut-allergic children aged 4-11 years.
OBJECTIVE


To assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) open-label extension PEOPLE study.
METHODS


Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250μg, subjects who had received DBV712 250μg in PEPITES underwent Month-36 double-blind, placebo-controlled, food challenge (DBPCFC) with an optional Month-38 sustained unresponsiveness (SU) assessment.
RESULTS


198 (93%) of 213 eligible subjects who had received DBV712 250μg in PEPITES entered PEOPLE, of whom 141 (71%) had assessable DBPCFC at Month 36. At Month 36, 51.8% (73/141) of subjects reached an eliciting dose (ED) of ≥1000 mg, compared with 40.4% (57/141) at Month 12. 75.9% (107/141) demonstrated increased ED compared to baseline. 13.5% (19/141) tolerated the full DBPCFC of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. 18 subjects underwent an optional SU assessment; 14/18 (77.8%) maintained an ED of ≥1000 mg at Month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).
CONCLUSION


These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.",2020,"Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).
","['peanut-allergic children aged 4-11 years', '198 (93%) of 213 eligible subjects who had received DBV712 250μg in PEPITES entered PEOPLE, of whom 141 (71%) had assessable DBPCFC at Month 36', '18 subjects underwent an', 'Subjects who completed PEPITES were offered enrollment in PEOPLE', 'Peanut Allergy in Children']","['Epicutaneous Immunotherapy', 'epicutaneous immunotherapy (EPIT™', 'optional SU', 'placebo-controlled, food challenge (DBPCFC) with an optional Month-38 sustained unresponsiveness (SU) assessment']","['Compliance', 'Median cumulative reactive dose', 'Local patch-site skin reactions', 'ED', 'interim safety and efficacy']","[{'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",213.0,0.147914,"Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ""Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, CO, USA. Electronic address: david.fleischer@childrenscolorado.org.""}, {'ForeName': 'Wayne G', 'Initials': 'WG', 'LastName': 'Shreffler', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ""Children's Hospital at Westmead, Sydney, Australia; DBV Technologies, Montrouge, France.""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': ""DBV Technologies, Montrouge, France; UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Anvari', 'Affiliation': ""Texas Children's Hospital, Houston, TX, USA; Baylor College of Medicine, Houston, TX, USA.""}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': ""Assa'ad"", 'Affiliation': ""Cincinnati Children's Hospital Medical Center, The University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bégin', 'Affiliation': 'Division of Clinical Immunology and Allergy, Department of Medicine, Université de Montréal, Montreal, QC Canada.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Bird', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Brown-Whitehorn', 'Affiliation': ""Division of Allergy and Immunology, The Children's Hospital of Philadelphia Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Aideen', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': ""Our Lady's Children's Hospital, Dublin, Ireland.""}, {'ForeName': 'Edmond S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': ""British Columbia Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Amarjit', 'Initials': 'A', 'LastName': 'Cheema', 'Affiliation': 'Cheema Research Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Hey', 'Initials': 'H', 'LastName': 'Chong', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Davis', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Ford', 'Affiliation': ""Children's Hospital at Westmead, Sydney, Australia; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': ""Service d'Allergie et Immunologie, Département de médecine, CHU de Québec, Québec, Canada.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': ""O'B Hourihane"", 'Affiliation': 'Paediatrics and Child Health, INFANT Centre and HRB-Clinical Research Facility, University College Cork, Cork, Ireland; Royal College of Surgeons, Ireland.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, AK, USA.""}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lange', 'Affiliation': 'St Marien Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Lanser', 'Affiliation': 'National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': ""University of California, San Diego, Rady Children's Hospital, San Diego, CA, USA.""}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mahler', 'Affiliation': 'Dept. of Dermatology, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany; Current address: Paul Ehrlich Institute, Langen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Maronna', 'Affiliation': 'Dept. of Dermatology, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowak-Wegrzyn', 'Affiliation': 'New York University Langone Health, New York, NY, USA; Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Roxanne C', 'Initials': 'RC', 'LastName': 'Oriel', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': ""Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Petroni', 'Affiliation': 'Seattle Allergy & Asthma Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': ""University of Western Australia School of Medicine, Perth, Children's Hospital, Nedlands, Australia.""}, {'ForeName': 'Lynda C', 'Initials': 'LC', 'LastName': 'Schneider', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Griffith University, Southport, Australia.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Staab', 'Affiliation': 'Charité-Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Gordon Sussman Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'University of Ottawa Medical School, Department of Medicine, Ottawa, Ontario, Canada.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lambert', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Peillon', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Bois', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'DBV Technologies, Montrouge, France; Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.028']
2511,32659365,Interlaminar Stabilization for Spinal Stenosis in a Medicare Population.,"BACKGROUND CONTEXT


The number of complex fusions performed on Medicare beneficiaries, defined as ≥ age 65, with lumbar spinal stenosis with or without spondylolisthesis has been increasing. Typically, these procedures are longer, more invasive and pose a greater risk for complications. Interlaminar stabilization (ILS) serves as an intermediary between decompression alone and decompression with fusion.
PURPOSE


The purpose of this study was to prospectively examine the efficacy of ILS in patients ≥ age 65 through comparison to fusion in the same age group and ILS in younger patients.
STUDY DESIGN/SETTING


A prospective, multi-centered, randomized controlled trial comparing decompression with ILS to decompression with posterolateral fusion with bilateral pedicle screw instrumentation.
PATIENT SAMPLE


Patients from 21 sites in the United States underwent surgery for moderate stenosis with up to a grade 1 degenerative spondylolisthesis and failure of conservative treatment with low back pain at 1 or 2 contiguous levels from L1-L5. Pre-operatively, patient-reported assessment had to meet the criteria of significant pain and disability (VAS back pain ≥ 50 mm on a 100 mm scale; Oswestry Disability Index of ≥ 20/50).
OUTCOME MEASURES


The primary outcome was overall Composite Clinical Success (CCS) as determined by Oswestry Disability Index (ODI) scores, incidence of postoperative epidural injections and/or reoperations, incidence of device-related complications, and persistent or progressive neurological deficit. Secondary outcomes included patient satisfaction as measured by Visual Analog Scale (VAS) for back and worse leg pain and Zurich Claudication Questionnaire (ZCQ) scores. Narcotic usage data and radiographic assessment of changes in postoperative posterior disc height and foraminal height were also evaluated.
METHODS


At 1- or 2-levels, 84 patients ≥ age 65 underwent decompression with ILS, 57 patients ≥ age 65 underwent decompression with fusion, and 131 patients < age 65 underwent decompression with ILS. Comparisons were made between ≥ age 65 ILS patients and ≥ age 65 fusion patients and between < age 65 and ≥ age 65 ILS patients. The patients were assessed before and after surgery at 6 weeks and 3, 6, 12, 18, 24, 48 and 60 months.
RESULTS


At 24 and 60 months, there were no statistically significant differences in CCS or any of the individual components of CCS between the ≥ age 65 ILS and fusion groups or between the < age 65 and ≥ age 65 ILS groups. ILS Medicare patients experienced significantly shorter surgeries (p<0.001), less blood loss (p<0.001), and a shorter hospital stay (p<0.001) than fusion patients. There were no significant differences radiographically or with regards to postoperative narcotic usage.
CONCLUSIONS


Clinically, ILS patients ≥ age 65 performed as well as both those receiving fusion and those < age 65 who received ILS. Importantly, however, for this older population, ILS Medicare patients experienced less blood loss, a shorter operation and shorter hospital stay than fusion Medicare patients.",2020,"ILS Medicare patients experienced significantly shorter surgeries (p<0.001), less blood loss (p<0.001), and a shorter hospital stay (p<0.001) than fusion patients.","['65 ILS patients and ≥ age 65 fusion patients and between < age 65 and ≥ age 65 ILS patients', 'patients ≥ age 65 through comparison to fusion in the same age group and ILS in younger patients', 'Spinal Stenosis in a Medicare Population', 'SAMPLE\n\n\nPatients from 21 sites in the United States underwent surgery for moderate stenosis with up to a grade 1 degenerative spondylolisthesis and failure of conservative treatment with low back pain at 1 or 2 contiguous levels from L1-L5', '84 patients ≥ age 65 underwent decompression with ILS, 57 patients ≥ age 65 underwent decompression with fusion, and 131 patients < age 65 underwent']","['Interlaminar stabilization (ILS', 'decompression with ILS to decompression with posterolateral fusion with bilateral pedicle screw instrumentation', 'decompression with ILS', 'Interlaminar Stabilization', 'ILS']","['shorter hospital stay', 'patient satisfaction as measured by Visual Analog Scale (VAS) for back and worse leg pain and Zurich Claudication Questionnaire (ZCQ) scores', 'hospital stay', 'pain and disability (VAS back pain', 'postoperative posterior disc height and foraminal height', 'blood loss', 'overall Composite Clinical Success (CCS) as determined by Oswestry Disability Index (ODI) scores, incidence of postoperative epidural injections and/or reoperations, incidence of device-related complications, and persistent or progressive neurological deficit']","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037944', 'cui_str': 'Spinal stenosis'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0264184', 'cui_str': 'Degenerative spondylolisthesis'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441996', 'cui_str': 'Foraminal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}]",,0.0548583,"ILS Medicare patients experienced significantly shorter surgeries (p<0.001), less blood loss (p<0.001), and a shorter hospital stay (p<0.001) than fusion patients.","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Grinberg', 'Affiliation': 'Integrated Spine Research Program, Spine Care Institute, Hospital for Special Surgery.'}, {'ForeName': 'Rachel Beth', 'Initials': 'RB', 'LastName': 'Simon', 'Affiliation': 'Integrated Spine Research Program, Spine Care Institute, Hospital for Special Surgery.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dowe', 'Affiliation': 'Integrated Spine Research Program, Spine Care Institute, Hospital for Special Surgery.'}, {'ForeName': 'Antonio T', 'Initials': 'AT', 'LastName': 'Brecevich', 'Affiliation': 'Integrated Spine Research Program, Spine Care Institute, Hospital for Special Surgery.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Cammisa', 'Affiliation': 'Chief Emeritus, Spinal Surgical Service, Integrated Spine Research Program, Spine Care Institute, Hospital for Special Surgery.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Abjornson', 'Affiliation': 'Director of Spine Research, Integrated Spine Research Program, Spine Care Institute, Hospital for Special Surgery. Electronic address: abjornsonc@hss.edu.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.06.015']
2512,32659437,Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods.,"Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. The objective of the On The Move randomized controlled trial is to test the effectiveness of a linguistically and culturally targeted SMS PA intervention (SMS PA Advisor) versus two comparison conditions: a) a standard, staff-delivered phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention to promote a healthy diet (SMS Nutrition Advisor). The study sample (N = 350) consists of generally healthy, insufficiently active Latino adults ages 35 years and older living in five northern California counties. Study assessments occur at baseline, 6, and 12 months, with a subset of participants completing 18-month assessments. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields. Trial Registration: clinicaltrial.gov Identifier = NCT02385591.",2020,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"['Latino population', 'The study sample (N\u202f=\u202f350) consists of generally healthy, insufficiently active Latino adults ages 35\u202fyears and older living in five northern California counties']","['phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention', 'linguistically and culturally targeted SMS PA intervention (SMS PA Advisor', 'Text messaging (SMS', 'physical activity advice delivered via text messaging vs. human phone advisors']","['12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0964757,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"[{'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Epidemiology & Population Health, Stanford University School of Medicine, Stanford, CA 94305, United States of America; Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: king@stanford.edu.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Campero', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: icampero@stanford.edu.'}, {'ForeName': 'Jylana L', 'Initials': 'JL', 'LastName': 'Sheats', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: JSheats@its.jnj.com.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Castro Sweet', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: cynthia@omadahealth.com.'}, {'ForeName': 'Patricia Rodriguez', 'Initials': 'PR', 'LastName': 'Espinosa', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: prespinosa@stanford.edu.'}, {'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dgarcia3@stanford.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hauser', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mehauser@stanford.edu.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Done', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mdone@stanford.edu.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Patel', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: michele.patel@stanford.edu.'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Parikh', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: nparikh@caremessage.org.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Corral', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: ccorral@caremessage.org.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Ahn', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dahn@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106084']
2513,32659480,Effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia: A randomized controlled trial.,"PURPOSE


The present study aimed to assess the effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia.
METHODS


Thirty-four participants with behavioral dysphonia were randomly assigned to one of two treatment groups: 1) voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program only (n=14). Laryngoscopic assessment was performed in all subjects. Before and after voice therapy, participants underwent aerodynamic, electroglottographic, and acoustic assessment. The Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE). Comparison for all variables were performed between experimental group and control group.
RESULTS


Wilcoxon test showed significant improvements for experimental group for VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase). Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
CONCLUSION


Physiologic voice therapy based on semioccluded vocal tract exercises seems to be an effective tool to improve voice in subjects diagnosed with behavioral dysphonia. Apparently, most changes should be expected in variables related to physical and functional aspects compared to objective variables. Subglottic pressure and phonation threshold pressure seem to be the most change-sensitive parameters and they may reflect a reduction in phonatory effort reported by patients after voice therapy.",2020,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","['subjects diagnosed with behavioral dysphonia', 'Thirty-four participants with behavioral dysphonia', 'subjects with behavioral dysphonia']","['physiologic voice therapy program', 'phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE', 'voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program', 'Physiologic voice therapy']","['VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase', 'Subglottic pressure and phonation threshold pressure', 'Laryngoscopic assessment', 'Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality', 'subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",34.0,0.0112718,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile; Department of Otolaryngology, Las Condes Clinic, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bertucci', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: terebertucci@gmail.com.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Pacheco', 'Affiliation': 'Department of Otolaryngology, Las Condes Clinic, Av. Estoril 850, Santiago, Chile. Electronic address: cpachecob@clinicalascondes.cl.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leiva', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad Pedro de Valdivia, Vicuña Mackena 44, Santiago, Chile. Electronic address: fernando.leiva.solari@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Quintana', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: quintana.b.felipe@gmail.com.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Ansaldi', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad de las Américas, Santiago, Chile. Electronic address: romina.ansaldi@gmail.com.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: cequezad@uc.cl.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Department of Otolaryngology, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: daniel.uchile@gmail.com.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106023']
2514,32664953,FEEding DURing red cell transfusion (FEEDUR RCT): a multi-arm randomised controlled trial.,"BACKGROUND


Necrotising Enterocolitis (NEC) is a devastating neonatal disease. A temporal association between red cell transfusion and NEC has been recognized and there have been concerns about the effects of feeding during transfusion. We aimed to assess the effect of different enteral feeding regimens on splanchnic oxygenation in preterm infants receiving red cell transfusions.
METHODS


This was an open, multi-arm, parallel-group, randomised controlled trial conducted in a single centre in Australia. We compared three different enteral feeding regimes during a single red cell transfusion in preterm infants < 35 weeks gestational age at birth. Infants were randomised to either: (1) Withholding enteral feeds for 12 h from the start of transfusion or; (2) Continuing enteral feeds or; (3) Restriction of enteral feed volume to 120 ml/kg/day (maximum 20 kcal/30 ml) for 12 h. The primary outcome was mean splanchnic-cerebral oxygenation ratio (SCOR) and mean splanchnic fractional oxygen extraction (FOE) before (1 h prior), during (1 h into transfusion) and after (end of transfusion; 12 and 24 h post) transfusion.
RESULTS


There were 60 transfusion episodes (20 transfusion episodes in each group) included in the analysis. 41 infants with a median gestational age at birth of 27 weeks (range 23-32 weeks) were enrolled. The median postnatal age was 43 days (range 19-94 days) and the median pre-transfusion haematocrit was 0.27 (range 0.22-0.32). All three groups were similar at baseline. There were no differences in mean SCOR and mean splanchnic FOE at any of the pre-specified time points. There were also no differences in clinical outcomes. There were no episodes of NEC in any infant. Across all groups the mean SCOR increased from the start to the end of each transfusion (0.97 [CI95% 0.96-0.98] vs 1.00 [CI95% 0.99-1.01]; p = 0.04) and the mean FOE decreased from the start to the end of each transfusion (0.22 [CI95% 0.21-0.23] vs 0.17 [CI95% 0.16-0.18]; p < 0.001).
CONCLUSIONS


There were no differences in splanchnic oxygenation when enteral feeds were either withheld, continued or restricted during a transfusion. However, the successful conduct of this study supports the feasibility of a large trial powered to assess clinical outcomes.
TRIAL REGISTRATION


ANZCTR, ACTRN12616000160437. Registered 10 February 2016, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370069.",2020,There were no differences in mean SCOR and mean splanchnic FOE at any of the pre-specified time points.,"['preterm infants receiving red cell transfusions', '41 infants with a median gestational age at birth of 27\u2009weeks (range 23-32\u2009weeks) were enrolled', 'preterm infants <\u200935\u2009weeks gestational age at birth']","['FEEding DURing red cell transfusion (FEEDUR RCT', 'enteral feeding regimens']","['mean splanchnic-cerebral oxygenation ratio (SCOR) and mean splanchnic fractional oxygen extraction (FOE) before (1\u2009h prior), during (1\u2009h into transfusion', 'mean SCOR', 'mean FOE', 'mean SCOR and mean splanchnic FOE', 'median postnatal age', 'median pre-transfusion haematocrit', 'splanchnic oxygenation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]",41.0,0.255223,There were no differences in mean SCOR and mean splanchnic FOE at any of the pre-specified time points.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, Australia. tim.schindler@health.nsw.gov.au.'}, {'ForeName': 'Kee Thai', 'Initials': 'KT', 'LastName': 'Yeo', 'Affiliation': ""Department of Neonatology, KK Women's & Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Bolisetty', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, Australia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Michalowski', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, Australia.'}, {'ForeName': 'Alvin Hock Kuan', 'Initials': 'AHK', 'LastName': 'Tan', 'Affiliation': 'Department of Neonatal and Perinatal Medicine, Flinders Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'Department of Newborn Care, Royal Hospital for Women, Sydney, Australia.'}]",BMC pediatrics,['10.1186/s12887-020-02233-3']
2515,32664962,A clinical trial to evaluate the effect of statin use on lowering aldosterone levels.,"BACKGROUND


Statins are the first-line pharmaceutical agent in the management of hypercholesterolemia and cardiovascular (CV) risk reduction, and the most commonly prescribed class of drugs worldwide. Studies describing CV risk reduction independent of LDL-cholesterol lowering have evoked an interest in the pleiotropic mechanisms of statins' benefits. We recently demonstrated that administration of statins in animal models lowers aldosterone levels and observed an association between statin use and reduced aldosterone levels in two human cohorts, with lipophilic statins displaying a greater effect than hydrophilic statins. Therefore, we designed a randomized, placebo-controlled, double-blinded intervention study to assess whether statin treatment lowers aldosterone in a type-dependent manner in humans, with simvastatin (lipophilic) showing a greater effect than pravastatin (hydrophilic).
METHODS/DESIGN


One hundred five healthy participants will be recruited from the general population to enroll in a 12-week, randomized, placebo-controlled, double-blinded, 3-arm clinical trial. Ninety participants are anticipated to complete the protocol. After baseline assessment of aldosterone levels, participants will be randomized to daily simvastatin, pravastatin, or placebo. Aldosterone levels will be assessed after 2 days on study drug and again after 6 weeks and 12 weeks on study drug. Prior to each aldosterone assessment, participants will consume an isocaloric sodium and potassium-controlled run-in diet for 5 days. Assessments will occur on an inpatient research unit to control for diurnal, fasting, and posture conditions. The primary outcome will compare 12-week angiotensin II-stimulated serum aldosterone by study drug. Secondary outcomes will compare baseline and 12-week 24-h urine aldosterone by study drug.
DISCUSSION


Results from this rigorous study design should provide strong support that statins lower aldosterone levels in humans. These results may explain some of the beneficial effects of statins that are not attributed to the LDL-lowering effect of this important class of medications. Results would demonstrate that statin lipophilicity is an important attribute in lowering aldosterone levels. The outcomes of this program will have implications for the design of studies involving statin medications, as well as for the differential use of classes of statins.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT02871687 ; First Posted August 18, 2016.",2020,"The outcomes of this program will have implications for the design of studies involving statin medications, as well as for the differential use of classes of statins.
","['Ninety participants', 'One hundred five healthy participants will be recruited from the general population to enroll in a 12-week, randomized']","['simvastatin, pravastatin, or placebo', 'statin', 'simvastatin (lipophilic', 'isocaloric sodium and potassium-controlled run-in diet', 'pravastatin (hydrophilic', 'placebo']","['12-week angiotensin II-stimulated serum aldosterone by study drug', 'aldosterone levels', 'Aldosterone levels', '24-h urine aldosterone by study drug']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilic'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0428395', 'cui_str': 'Aldosterone measurement, serum'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}]",105.0,0.323852,"The outcomes of this program will have implications for the design of studies involving statin medications, as well as for the differential use of classes of statins.
","[{'ForeName': 'Ezra S', 'Initials': 'ES', 'LastName': 'Hornik', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Altman-Merino', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Koefoed', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Meyer', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Isabella B', 'Initials': 'IB', 'LastName': 'Stone', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Green', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Williams', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Gail K', 'Initials': 'GK', 'LastName': 'Adler', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA. jwilliams5@bwh.harvard.edu.""}]",BMC endocrine disorders,['10.1186/s12902-020-00587-4']
2516,32664987,"Effectiveness of the baby-friendly community initiative in promoting exclusive breastfeeding among HIV negative and positive mothers: a randomized controlled trial in Koibatek Sub-County, Baringo, Kenya.","BACKGROUND


Although the baby-friendly community initiative (BFCI) has been proposed as a community-level approach to improve infant feeding practices, there is little data on its variation in effectiveness by HIV status. We conducted a study to determine the effectiveness of BFCI in changing knowledge and attitudes towards exclusive breastfeeding (EBF) and increasing the rates among HIV negative and HIV positive women in rural Kenya.
METHODS


A community-based cluster-randomized controlled trial was implemented from April 2015 to December 2016 among 901 women enrolled across 13 clusters. The intervention groups received a minimum of 12 personalized home-based counselling sessions on infant feeding by trained community health volunteers from their first or second trimester of pregnancy until 6 months postpartum. Other interventions included education sessions at maternal child clinics, mother-to-mother support group meetings and bi-monthly baby-friendly gatherings targeting influencers. The control group received standard health education at the facility and during monthly routine home visits by community health volunteers not trained on BFCI. Primary outcome measures were the rates of EBF at week 1, months 2, 4 and 6 postpartum. Secondary outcomes included knowledge and attitudes regarding breastfeeding for HIV-exposed infants. Statistical methods included analysis of covariance and logistic regression.
RESULTS


At 6 months, EBF rates among HIV negative mothers were significantly higher in the BFCI intervention arm compared to the control arm (81.7% versus 42.2% p = 0.001). HIV positive mothers in the intervention arm had higher EBF rates at 6 months than the control but the difference was not statistically significant (81.8% versus 58.4%; p = 0.504). In HIV negative group, there was greater knowledge regarding EBF for HIV-exposed infants in the intervention arm than in the control (92.1% versus 60.7% p = 0.001). Among HIV positive mothers, such knowledge was high among both the intervention and control groups (96% versus 100%, p > 0.1). HIV negative and positive mothers in the intervention arm had more favourable attitudes regarding EBF for HIV-exposed infants than the control (84.5% versus 62.1%, p = 0.001) and (94.6% versus 53.8% to p = 0.001) respectively.
CONCLUSIONS


BFCI interventions can complement facility-based interventions to improve exclusive and continued breastfeeding knowledge, attitudes, and behaviours among HIV negative and positive women.",2020,HIV positive mothers in the intervention arm had higher EBF rates at 6 months than the control but the difference was not statistically significant (81.8% versus 58.4%; p = 0.504).,"['HIV negative and positive mothers', 'A community-based cluster-randomized controlled trial was implemented from April 2015 to December 2016 among 901 women enrolled across 13 clusters', 'HIV negative and HIV positive women in rural Kenya']","['minimum of 12 personalized home-based counselling sessions', 'BFCI', 'standard health education at the facility and during monthly routine home visits by community health volunteers\xa0not trained on BFCI', 'education sessions at maternal child clinics, mother-to-mother support group meetings and bi-monthly baby-friendly gatherings targeting influencers', 'baby-friendly community initiative']","['rates of EBF', 'knowledge regarding EBF', 'EBF rates', 'knowledge and attitudes regarding breastfeeding for HIV-exposed infants']","[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",901.0,0.0667188,HIV positive mothers in the intervention arm had higher EBF rates at 6 months than the control but the difference was not statistically significant (81.8% versus 58.4%; p = 0.504).,"[{'ForeName': 'Betty Mogesi', 'Initials': 'BM', 'LastName': 'Samburu', 'Affiliation': 'Formerly Division of Nutrition and Dietetics, Ministry of Health in Kenya, Nairobi, Kenya. betsamburu@gmail.com.'}, {'ForeName': 'Sera Lewise', 'Initials': 'SL', 'LastName': 'Young', 'Affiliation': 'Institute of Policy Research, Northwestern University, Evanston, USA.'}, {'ForeName': 'Frederick Murunga', 'Initials': 'FM', 'LastName': 'Wekesah', 'Affiliation': 'Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi, Kenya.'}, {'ForeName': 'Milkah Njeri', 'Initials': 'MN', 'LastName': 'Wanjohi', 'Affiliation': 'Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi, Kenya.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kimiywe', 'Affiliation': 'Department of Foods, Nutrition and Dietetics, Kenyatta University, Nairobi, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Muriuki', 'Affiliation': 'Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi, Kenya.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Griffiths', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'McGarvey', 'Affiliation': 'International Health Institute, Brown University School of Public Health, Providence, USA.'}, {'ForeName': 'Nyovani Janet', 'Initials': 'NJ', 'LastName': 'Madise', 'Affiliation': 'African Institute for Development Policy, Lilongwe, Malawi.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Kimani-Murage', 'Affiliation': 'Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi, Kenya.'}]",International breastfeeding journal,['10.1186/s13006-020-00299-4']
2517,32664995,Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy.,"BACKGROUND


The phase 2 BRIGHT AML 1003 trial evaluated efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized patients to receive glasdegib + LDAC (n = 78) or LDAC alone (n = 38). The rate of complete remission (CR) was 19.2% in the glasdegib + LDAC arm versus 2.6% in the LDAC arm (P = 0.015).
METHODS


This post hoc analysis determines whether the clinical benefits of glasdegib are restricted to patients who achieve CR, or if they extend to those who do not achieve CR.
RESULTS


In patients who did not achieve CR, the addition of glasdegib to LDAC improved overall survival (OS) versus LDAC alone (hazard ratio = 0.63 [95% confidence interval, 0.41-0.98]; P = 0.0182; median OS, 5.0 vs 4.1 months). Additionally, more patients receiving glasdegib + LDAC achieved durable recovery of absolute neutrophil count (≥ 1000/μl, 45.6% vs 35.5%), hemoglobin (≥ 9 g/dl, 54.4% vs 38.7%), and platelets (≥ 100,000/μl, 29.8% vs 9.7%). Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively.
CONCLUSIONS


Collectively, these data suggest that there are clinical benefits with glasdegib in the absence of CR.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01546038 (March 7, 2012).",2020,"Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively.
","['patients with acute myeloid leukemia ineligible for intensive chemotherapy', 'patients with acute myeloid leukemia treated with glasdegib and low-dose']","['LDAC alone', 'cytarabine', 'glasdegib + LDAC', 'glasdegib + low-dose cytarabine (LDAC']","['rate of complete remission (CR', 'durable recovery of absolute neutrophil count', 'hemoglobin', 'Survival outcomes and clinical benefit', 'Transfusion independence', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.257089,"Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively.
","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta, CA, USA. jorge.cortes@augusta.edu.'}, {'ForeName': 'Florian H', 'Initials': 'FH', 'LastName': 'Heidel', 'Affiliation': 'Otto-von-Guericke University Medical Center Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'B Douglas', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Department of Hematology, Medical University of Łódź and Copernicus Memorial Hospital, Łódź, Poland.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain; CIBERONC, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Candoni', 'Affiliation': 'Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Juravinski Hospital at Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Mikkael A', 'Initials': 'MA', 'LastName': 'Sekeres', 'Affiliation': 'Leukemia Program, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Pollyea', 'Affiliation': 'Division of Hematology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Ferdinand', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Weidong Wendy', 'Initials': 'WW', 'LastName': 'Ma', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': ""O'Connell"", 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00929-8']
2518,32665039,"Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada.","OBJECTIVES


Primary Objective: To determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily reduces microbiologically confirmed COVID-19 among front line health care workers at high risk for SARS-CoV-2 exposure. Secondary Objectives: To compare the following between study arms: adverse events; symptomatic COVID-19; duration of symptomatic COVID-19; days hospitalized attributed to COVID-19; respiratory failure attributable to COVID-19 requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; mortality attributed to COVID-19, number of days unable to work attributed to COVID-19, seroconversion (COVID-19 negative to COVID-19 positive over the study period); ability of participant plasma to neutralize SARS-CoV-2 virus in vitro; To describe short-term psychological distress associated with risk of COVID-19 exposure at 1, 60, 120 days of the study. To explore laboratory markers within participants with confirmed COVID-19: including circulating markers of host immune and endothelial activation in participant plasma and their correlation with disease severity and outcome TRIAL DESIGN: The HEROS study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), placebo controlled, participant and investigator-blinded, multi-site superiority trial of oral HCQ 400 mg taken once daily for 90 days as PrEP to prevent COVID-19 in health care workers at high risk of SARS-CoV-2 exposure. At 90 days, there is an open label extension wherein all participants are offered a one-month course of HCQ 400mg once daily for PrEP of COVID-19.
PARTICIPANTS


Frontline HCWs aged 18 years of age or older, at high risk of SARS-CoV-2 exposure (including staff of emergency departments, intensive care units, intubation teams, COVID-wards, and staff deployed to Long Term Care facilities) of five academic hospitals in downtown Toronto, Canada. Exclusion criteria include: currently pregnant, planning to become pregnant during the study period, and/or breast feeding; known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds; current use of hydroxychloroquine; known prolonged QT syndrome and/or baseline resting ECG with QTc>450 ms and/or concomitant medications which simultaneously may prolong the QTc that cannot be temporarily suspended/replaced; known pre-existing retinopathy, G6PD deficiency, porphyria, liver disease including cirrhosis, encephalopathy, hepatitis or alcoholism, diabetes on oral hypoglycemics or insulin, or renal insufficiency/failure; disclosure of self-administered use of hydroxychloroquine or chloroquine within 12 weeks prior to study; confirmed symptomatic COVID-19 at time of enrollment.
INTERVENTION AND COMPARATOR


Intervention: hydroxychloroquine, 400mg (2 tablets) orally per day. Comparator: placebo, two tablets visually identical to the intervention, orally per day MAIN OUTCOMES: The primary outcome is microbiologically confirmed COVID-19 (i.e. SARS-CoV-2 infection). This is a composite endpoint which includes positive results from any validated SARS-CoV-2 diagnostic assay including detection of viral RNA, and/or seroconversion. Participants will be assessed at baseline, and then undergo monthly follow-up at day 30, 60, and 90, 120. At each visit, participants will provide an oropharyngeal sample, blood sample, and will undergo electrocardiogram monitoring of the QTc interval. Secondary outcome measures include: adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2 at day 1, 60, 120 days using the K10, a validated measure of non-specific psychological distress.
RANDOMISATION


Within each site, participants will be individually randomized to either the intervention arm with HCQ or the placebo arm using a fixed 1:1 allocation ratio using an interactive web-based response system to ensure concealment of allocation. Randomization schedules will be computer-generated and blocked using variable block sizes.
BLINDING (MASKING)


All participants, research coordinators, technicians, clinicians and investigators will be blinded to the participant allocation group. Numbers to be randomised (sample size) N=988, randomised into two groups of 494 patients.
TRIAL STATUS


This summary describes protocol version No. 1.6, May 15, 2020. Recruitment is ongoing - started April 20, 2020 and anticipated end date is July 30, 2021 TRIAL REGISTRATION: ISRCTN.com Identifier: ISRCTN14326006, registered April 14, 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Secondary outcome measures include: adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2 at day 1, 60, 120 days using the K10, a validated measure of non-specific psychological distress.
","['Frontline HCWs aged 18 years of age or older, at high risk of SARS-CoV-2 exposure (including staff of emergency departments, intensive care units, intubation teams, COVID-wards, and staff deployed to Long Term Care facilities) of five academic hospitals in downtown Toronto, Canada', 'health care workers at high risk of SARS-CoV-2 exposure', 'participants with confirmed COVID-19', 'front line health care workers at high risk for SARS-CoV-2 exposure', '494 patients']","['invasive ventilation or ii) intubation/mechanical ventilation', 'ISRCTN.com', 'hydroxychloroquine', 'hydroxychloroquine or chloroquine', 'HCQ 400mg once daily for PrEP of COVID-19', 'Comparator: placebo', 'HCQ or the placebo', 'HCQ', 'hydroxychloroquine (HCQ', 'Hydroxychloroquine Pre-exposure Prophylaxis', 'placebo']","[' adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2', 'microbiologically confirmed COVID-19 (i.e. SARS-CoV-2 infection', 'validated measure of non-specific psychological distress']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559457', 'cui_str': 'Number of days off work'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.440916,"Secondary outcome measures include: adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2 at day 1, 60, 120 days using the K10, a validated measure of non-specific psychological distress.
","[{'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Wright', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walmsley', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hulme', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': ""O'Connor"", 'Affiliation': 'Emergency Department, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Snider', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Emergency Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Adrienne K', 'Initials': 'AK', 'LastName': 'Chan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bjug', 'Initials': 'B', 'LastName': 'Borgundvaag', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'McLeod', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gollob', 'Affiliation': 'Division of Cardiology, Department of Medicine, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Rosemarie J', 'Initials': 'RJ', 'LastName': 'Clarke', 'Affiliation': 'Immunodeficiency Clinic, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Dresser', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Haji', 'Affiliation': 'Investigational Pharmacy Services, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mazzulli', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Mubareka', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': ""Applied Health Research Centre (AHRC), St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Kain', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Landes', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada. megan.landes@uhn.ca.'}]",Trials,['10.1186/s13063-020-04577-8']
2519,32665041,Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial.,"OBJECTIVES


Objective 1: To determine if it is feasible to conduct an RCT of online Sudarshan Kriya Yoga (SKY) for frontline hospital and long-term care home staff under the constraints imposed by the COVID-19 pandemic and need for remote trial monitoring. Objective 2: To assess whether online versions of SKY and/or Health Enhancement Program (HEP) result in improvement in self-rated measures of insomnia, anxiety, depression, and resilience.
TRIAL DESIGN


This is an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention SKY versus an online control mind-body intervention HEP in frontline hospital and long-term care home staff managing the COVID-19 pandemic.
PARTICIPANTS


Participants will include frontline hospital and long-term care home staff that are involved in the management of COVID-19 patients in London, Ontario, Canada. Participants will be willing and able to attend via online video conferencing software to participate in the study interventions. Participants must have an adequate understanding of English and be able to sit without physical discomfort for 60 minutes.
INTERVENTION AND COMPARATOR


Sudarshan Kriya Yoga (SKY): The online version of SKY will be delivered by at least one certified Canadian SKY teacher, with at least one back up teacher at all times, under the supervision of Ms. Ronnie Newman, Director of Research and Health Promotion, Art of Living Foundation, USA. The online version of SKY for healthcare workers has a total duration of 3 hours. Phase I will consist of 5 self-paced online modules of 4-10 minutes each to learn the breath control techniques. Participants will be sent an online survey in REDCap requesting that they self-confirm completion of the Phase I modules. In Phase II, 2 interactive online sessions of 1 hour each will be held on consecutive days with a certified SKY teacher, during which participants will learn the fast, medium and slow breaths. For ease of scheduling, multiple time windows will be offered for Phase II. There will be at least one back up teacher at all times. Both Phase I and II will be completed in the first week. Health Enhancement Program (HEP): The active control arm, HEP, will consist of time-matched online self-paced modules for Phase I. Phase II will consist of mindfulness-based meditation sessions delivered by mental health staff. HEP will be an active treatment program that incorporates mind-body interventions. HEP will consist of time-matched online self-paced modules with psychoeducation on healthy active living as well as interactive modules comprising of guided de-stressing exercises including music therapy, mindfulness and progressive muscle relaxation. Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms.
MAIN OUTCOMES


The following feasibility outcomes will be measured at the end of the study: (1) rate of participant recruitment, (2) rate of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected costs. Such measures will be collected on a daily basis through-out the study and tabulated 5 weeks later at the end of the study.
RANDOMISATION


Participants will be randomized after they have electronically signed the consent form and the research staff have confirmed eligibility. We will use REDCap to perform randomization in a 1:1 ratio as well as allocation concealment. REDCap is widely used by health researchers worldwide to significantly reduce data entry and study management errors to improve data fidelity.
BLINDING (MASKING)


All study participants will be blinded to the study hypotheses so as to prevent any expectation bias. Group allocation will be masked during analysis.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


This study will randomize a total of 60 participants in a 1:1 ratio to either SKY or HEP interventions.
TRIAL STATUS


Protocol version number 2.0 (June 5, 2020). Recruitment is currently ongoing (starting June 25, 2020). We anticipate to complete recruitment by June 30, 2021 and complete the study by September 30, 2021.
TRIAL REGISTRATION


ClinicalTrials.gov protocol ID NCT04368676 (posted April 30, 2020).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms.
","['60 participants in a 1:1 ratio to either SKY or HEP interventions', 'Protocol version number 2.0 (June 5, 2020', 'Participants will include frontline hospital and long-term care home staff that are involved in the management of COVID-19 patients in London, Ontario, Canada']","['HEP', 'Health Enhancement Program (HEP', 'Sudarshan Kriya Yoga (SKY', 'online versions of SKY and/or Health Enhancement Program (HEP', 'REDCap']","['Breath Regulation and yogic Exercise', 'insomnia, anxiety, depression, and resilience', 'rate of participant recruitment, (2) rate of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected costs']","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",60.0,0.152288,"Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms.
","[{'ForeName': 'Ka Sing Paris', 'Initials': 'KSP', 'LastName': 'Lai', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Watt', 'Affiliation': 'Department of Psychiatry, Parkwood Institute of Mental Health, 550 Wellington Rd, London, ON, N6C 5J1, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ionson', 'Affiliation': 'Department of Psychiatry, Parkwood Institute of Mental Health, 550 Wellington Rd, London, ON, N6C 5J1, Canada.'}, {'ForeName': 'Imants', 'Initials': 'I', 'LastName': 'Baruss', 'Affiliation': ""Department of Psychology, King's University College at Western University, 266 Epworth Ave, London, ON, N6A 2M3, Canada.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Forchuk', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Javeed', 'Initials': 'J', 'LastName': 'Sukhera', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Amer M', 'Initials': 'AM', 'LastName': 'Burhan', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Akshya', 'Initials': 'A', 'LastName': 'Vasudev', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada. akshya.vasudev@lhsc.on.ca.'}]",Trials,['10.1186/s13063-020-04583-w']
2520,32665040,The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.
TRIAL DESIGN


ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management.
PARTICIPANTS


Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently.
INTERVENTION AND COMPARATOR


Participants will be randomised 1:1:1:1 to: Group 1: standard of care; Group 2: lopinavir (400mg) / ritonavir (100mg) twice daily for 10 days in tablet form; Group 3: hydroxychloroquine (800mg) 4x200mg administered 12 hours apart on Day 1, followed by 400mg twice a day for 6 days; Group 4: lopinavir /ritonavir plus hydroxychloroquine.
MAIN OUTCOMES


Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation) at 15 days after enrolment. A range of clinical and virological secondary outcomes will also be evaluated.
RANDOMISATION


The randomisation schedule will be generated by an independent statistician. Randomisation will be stratified by site and will be in permuted blocks of variable block size. The randomised sequence allocation will only be accessible to the data management group, and site investigators will have individual participant allocation provided through a web-based trial enrolment platform.
BLINDING (MASKING)


This is an open-label study, with researchers assessing the laboratory outcomes blinded to treatment allocation. No unblinding procedures relating to potential adverse effects are therefore required.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


We assumed that 5% of participants receiving standard of care would meet the primary outcome, aimed to evaluate whether interventions could lead to a relative risk of 0.5, assuming no interaction between intervention arms. This corresponds to a required sample size of 610 per arm, with a 5% two-sided significance level (alpha) and 80% power. The total sample size therefore is planned to be 2440.
TRIAL STATUS


ASCOT protocol version 3, May 5, 2020. Recruitment opened April 4, 2020 and is ongoing, with planned completion of enrolment July 31, 2021.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ( ACTRN12620000445976 ). Prospectively registered April 6, 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.
","['Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently', 'Admitted patients will be eligible if aged ≥ 18 years', 'Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors', 'participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection', 'hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with', 'compared to standard of care']","['lopinavir /ritonavir plus hydroxychloroquine', 'lopinavir/ritonavir ', 'hydroxychloroquine', 'lopinavir /ritonavir, hydroxychloroquine', 'lopinavir/ritonavir and/or hydroxychloroquine', 'lopinavir (400mg) / ritonavir']",['Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation'],"[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0678798', 'cui_str': 'Adverse drug interaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0558281', 'cui_str': 'Regional center'}, {'cui': 'C0033176', 'cui_str': 'Private Sector'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",,0.374402,"hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.
","[{'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Denholm', 'Affiliation': 'Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia. justin.denholm@mh.org.au.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paterson', 'Affiliation': 'University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morpeth', 'Affiliation': 'Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dominica', 'Initials': 'D', 'LastName': 'Zentner', 'Affiliation': 'Department of Cardiology, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rees', 'Affiliation': 'Department of Respiratory Medicine, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'Centre for Infectious Diseases and Microbiology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Centre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Telehealth Kids Institute, Perth, West Australia, Australia.'}, {'ForeName': 'Steven Y C', 'Initials': 'SYC', 'LastName': 'Tong', 'Affiliation': 'Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04576-9']
2521,32665059,"Individualised positive end-expiratory pressure guided by electrical impedance tomography for robot-assisted laparoscopic radical prostatectomy: a prospective, randomised controlled clinical trial.","BACKGROUND


Robot-assisted laparoscopic radical prostatectomy requires general anaesthesia, extreme Trendelenburg positioning and capnoperitoneum. Together these promote impaired pulmonary gas exchange caused by atelectasis and may contribute to postoperative pulmonary complications. In morbidly obese patients, a recruitment manoeuvre (RM) followed by individualised PEEP improves intraoperative oxygenation and end-expiratory lung volume (EELV). We hypothesised that individualised PEEP with initial RM similarly improves intraoperative oxygenation and EELV in non-obese individuals undergoing robot-assisted prostatectomy.
METHODS


Forty males (age, 49-76 yr; BMI <30 kg m -2 ) undergoing prostatectomy received volume-controlled ventilation (tidal volume 8 ml kg -1  predicted body weight). Participants were randomised to either (1) RM followed by individualised PEEP (RM/PEEP IND ) optimised using electrical impedance tomography or (2) no RM with 5 cm H 2 O PEEP. The primary outcome was the ratio of arterial oxygen partial pressure to fractional inspired oxygen (Pao 2 /F i o 2 ) before the last RM before extubation. Secondary outcomes included regional ventilation distribution and EELV which were measured before, during, and after anaesthesia. The cardiovascular effects of RM/PEEP IND  were also assessed.
RESULTS


In 20 males randomised to RM/PEEP IND , the median PEEP IND  was 14 cm H 2 O [inter-quartile range, 8-20]. The Pao 2 /F i o 2  was 10.0 kPa higher with RM/PEEP IND  before extubation (95% confidence interval [CI], 2.6-17.3 kPa; P=0.001). RM/PEEP IND  increased end-expiratory lung volume by 1.49 L (95% CI, 1.09-1.89 L; P<0.001). RM/PEEP IND  also improved the regional ventilation of dependent lung regions. Vasopressor and fluid therapy was similar between groups, although 13 patients randomised to RM/PEEP IND  required pharmacological therapy for bradycardia.
CONCLUSION


In non-obese males, an individualised ventilation strategy improved intraoperative oxygenation, which was associated with higher end-expiratory lung volumes during robot-assisted laparoscopic prostatectomy.
CLINICAL TRIAL REGISTRATION


DRKS00004199 (German clinical trials registry).",2020,"i o 2  was 10.0 kPa higher with RM/PEEP IND  before extubation (95% confidence interval [CI], 2.6-17.3 kPa; P=0.001).","['morbidly obese patients', 'Forty males (age, 49-76 yr', '20 males randomised to', 'non-obese individuals undergoing robot-assisted prostatectomy']","['RM followed by individualised PEEP (RM/PEEP IND ) optimised using electrical impedance tomography or (2) no RM with 5 cm H', 'Individualised positive end-expiratory pressure guided by electrical impedance tomography for robot-assisted laparoscopic radical prostatectomy', 'F', 'Robot-assisted laparoscopic radical prostatectomy', 'RM/PEEP IND', 'Vasopressor and fluid therapy']","['ratio of arterial oxygen partial pressure to fractional inspired oxygen (Pao 2', 'intraoperative oxygenation', 'intraoperative oxygenation and end-expiratory lung volume (EELV', 'regional ventilation distribution and EELV', 'regional ventilation of dependent lung regions', 'intraoperative oxygenation and EELV', 'RM/PEEP IND  increased end-expiratory lung volume']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.551583,"i o 2  was 10.0 kPa higher with RM/PEEP IND  before extubation (95% confidence interval [CI], 2.6-17.3 kPa; P=0.001).","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Girrbach', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany; Innovation Centre Computer Assisted Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': 'Clinical Trial Centre, University of Leipzig, Leipzig, Germany; Integrated Research and Treatment Centre (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Lange', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Klotz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Scherz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Giannella-Neto', 'Affiliation': 'Laboratory of Pulmonary Engineering, Biomedical Engineering Program, Alberto Luis Coimbra Institute of Post-Graduation and Research in Engineering, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Beda', 'Affiliation': 'Department of Electronic Engineering, BioSiX-Biomedical Signal Processing, Analysis and Simulation Group, Postgraduate Program of Electrical Engineering (PPGEE), Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Alcendino', 'Initials': 'A', 'LastName': 'Jardim-Neto', 'Affiliation': 'Laboratory of Pulmonary Engineering, Biomedical Engineering Program, Alberto Luis Coimbra Institute of Post-Graduation and Research in Engineering, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; Department of Electronic Engineering, BioSiX-Biomedical Signal Processing, Analysis and Simulation Group, Postgraduate Program of Electrical Engineering (PPGEE), Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Stolzenburg', 'Affiliation': 'Department of Urology, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Reske', 'Affiliation': 'Innovation Centre Computer Assisted Surgery, University of Leipzig, Leipzig, Germany; Department of Anaesthesiology, Intensive Care and Emergency Medicine, Pain Therapy, Heinrich-Braun-Hospital, Zwickau, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wrigge', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Emergency Medicine, Pain Therapy, Bergmannstrost Hospital Halle, Halle, Germany; Integrated Research and Treatment Centre (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany; Integrated Research and Treatment Centre (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany. Electronic address: arbeit.simon@gmail.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.041']
2522,32665344,Study protocol of the Health4Life initiative: a cluster randomised controlled trial of an eHealth school-based program targeting multiple lifestyle risk behaviours among young Australians.,"INTRODUCTION


Lifestyle risk behaviours, including alcohol use, smoking, poor diet, physical inactivity, poor sleep (duration and/or quality) and sedentary recreational screen time ('the Big 6'), are strong determinants of chronic disease. These behaviours often emerge during adolescence and co-occur. School-based interventions have the potential to address risk factors prior to the onset of disease, yet few eHealth school-based interventions target multiple behaviours concurrently. This paper describes the protocol of the  Health4Life Initiative , an eHealth school-based intervention that concurrently addresses the Big 6 risk behaviours among secondary school students.
METHODS AND ANALYSIS


A multisite cluster randomised controlled trial will be conducted among year 7 students (11-13 years old) from 72 Australian schools. Stratified block randomisation will be used to assign schools to either the  Health4Life  intervention or an active control (health education as usual).  Health4Life  consists of (1) six web-based cartoon modules and accompanying activities delivered during health education (once per week for 6 weeks), and a smartphone application (universal prevention), and (2) additional app content, for students engaging in two or more risk behaviours when they are in years 8 and 9 (selective prevention). Students will complete online self-report questionnaires at baseline, post intervention, and 12, 24 and 36 months after baseline. Primary outcomes are consumption of sugar-sweetened beverages, moderate-to-vigorous physical activity, sleep duration, sedentary recreational screen time and uptake of alcohol and tobacco use.
ETHICS AND DISSEMINATION


This study has been approved by the University of Sydney (2018/882), NSW Department of Education (SERAP no. 2019006), University of Queensland (2019000037), Curtin University (HRE2019-0083) and relevant Catholic school committees. Results will be presented to schools and findings disseminated via peer-reviewed journals and scientific conferences. This will be the first evaluation of an eHealth intervention, spanning both universal and selective prevention, to simultaneously target six key lifestyle risk factors among adolescents.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12619000431123), 18 March 2019.",2020,"Students will complete online self-report questionnaires at baseline, post intervention, and 12, 24 and 36 months after baseline.","['2019006), University of Queensland (2019000037), Curtin University (HRE2019-0083) and relevant Catholic school committees', 'year 7 students (11-13\u2009years old) from 72 Australian schools', 'University of Sydney (2018/882), NSW Department of Education (SERAP no', 'secondary school students', 'young Australians']","['eHealth school-based program targeting multiple lifestyle risk behaviours', 'Health4Life  consists of (1) six web-based cartoon modules and accompanying activities delivered during health education', 'Health4Life  intervention or an active control (health education as usual']","['consumption of sugar-sweetened beverages, moderate-to-vigorous physical activity, sleep duration, sedentary recreational screen time and uptake of alcohol and tobacco use']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholic, follower of religion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]",,0.051763,"Students will complete online self-report questionnaires at baseline, post intervention, and 12, 24 and 36 months after baseline.","[{'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia katrina.champion@sydney.edu.au.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Newton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Kay-Lambkin', 'Affiliation': 'Priority Research Centre for Brain and Mental Health, The University of Newcastle Faculty of Health and Medicine, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Thornton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Slade', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sunderland', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Gardner', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Parmenter', 'Affiliation': 'Department of Exercise Physiology, University of NSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'School of Education, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nyanda', 'Initials': 'N', 'LastName': 'McBride', 'Affiliation': 'National Drug Research Institute, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Allsop', 'Affiliation': 'National Drug Research Institute, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Spring', 'Affiliation': 'Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Scarlett', 'Initials': 'S', 'LastName': 'Smout', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'Osman', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035662']
2523,32665367,Oral immunotherapy for treatment of peanut allergy.,"The US Food and Drug Administration's approval of a peanut oral immunotherapy product in January 2020 is a landmark development in the field of food allergy therapy. While food allergy prevalence has been increasing, this product is the first approved therapy for food allergy. Oral immunotherapy has many similarities to subcutaneous immunotherapy and drug desensitization protocols, but does not lead to sustained unresponsiveness. The studies leading to approval of the Palforzia product demonstrated increase in the amount of peanut protein able to be consumed, with 67% of subjects randomized to the treatment arm able to consume 600 mg of peanut protein in double-blind placebo-controlled food challenge at study exit. However, side effects are an important consideration, and dropout rates in studies of Palforzia ranged from 11% to 21%. Postmarketing surveillance of this product will be critical in assessing its long-term risks and benefits.",2020,The US Food and Drug Administration's approval of a peanut oral immunotherapy product in January 2020 is a landmark development in the field of food allergy therapy.,['peanut allergy'],['Oral immunotherapy'],[],"[{'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]",[],,0.033605,The US Food and Drug Administration's approval of a peanut oral immunotherapy product in January 2020 is a landmark development in the field of food allergy therapy.,"[{'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Dunlop', 'Affiliation': 'Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA jdunlop7@jhmi.edu.'}]",Journal of investigative medicine : the official publication of the American Federation for Clinical Research,['10.1136/jim-2020-001422']
2524,32665372,Transmitted Home Oximetry and Duration of Home Oxygen in Premature Infants.,"OBJECTIVES


To determine if a home oxygen therapy (HOT) management strategy that includes analysis of recorded home oximetry (RHO) data, compared with standard monthly clinic visit assessments, reduces duration of HOT without harm in premature infants.
METHODS


The RHO trial was an unmasked randomized clinical trial conducted in 9 US medical centers from November 2013 to December 2017, with follow-up to February 2019. Preterm infants with birth gestation ≤37 + 0/7 weeks, discharged on HOT, and attending their first pulmonary visit were enrolled. The intervention was an analysis of transmitted RHO between clinic visits ( n  = 97); the standard-care group received monthly clinic visits with in-clinic weaning attempts ( n  = 99). The primary outcomes were the duration of HOT and parent-reported quality of life. There were 2 prespecified secondary safety outcomes: change in weight and adverse events within 6 months of HOT discontinuation.
RESULTS


Among 196 randomly assigned infants (mean birth gestational age: 26.9 weeks; SD: 2.6 weeks; 37.8% female), 166 (84.7%) completed the trial. In the RHO group, the mean time to discontinue HOT was 78.1 days (SE: 6.4), compared with 100.1 days (SE: 8.0) in the standard-care group ( P  = .03). The quality-of-life scores improved from baseline to 3 months after discontinuation of HOT in both groups ( P  = .002), but the degree of improvement did not differ significantly between groups ( P  = .75).
CONCLUSIONS


RHO was effective in reducing the duration of HOT in premature infants. Parent quality of life improved after discontinuation. RHO allows physicians to determine which infants can be weaned and which need prolonged oxygen therapy between monthly visits.",2020,"The quality-of-life scores improved from baseline to 3 months after discontinuation of HOT in both groups ( P  = .002), but the degree of improvement did not differ significantly between groups ( P  = .75).
","['Preterm infants with birth gestation ≤37 + 0/7 weeks, discharged on HOT, and attending their first pulmonary visit were enrolled', '9 US medical centers from November 2013 to December 2017, with follow-up to February 2019', 'premature infants', 'Premature Infants', '196 randomly assigned infants (mean birth gestational age: 26.9 weeks; SD: 2.6 weeks; 37.8% female), 166 (84.7%) completed the trial']","['home oxygen therapy (HOT', 'standard-care group received monthly clinic visits with in-clinic weaning attempts']","['weight and adverse events', 'duration of HOT and parent-reported quality of life', 'quality-of-life scores', 'mean time to discontinue HOT', 'duration of HOT', 'Parent quality of life']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.10675,"The quality-of-life scores improved from baseline to 3 months after discontinuation of HOT in both groups ( P  = .002), but the degree of improvement did not differ significantly between groups ( P  = .75).
","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Rhein', 'Affiliation': 'Divisions of Neonatology and lawrence.rhein@umassmemorial.org.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'White', 'Affiliation': 'Divisions of Neonatology and.'}, {'ForeName': 'Tregony', 'Initials': 'T', 'LastName': 'Simoneau', 'Affiliation': ""Division of Pediatric Pulmonology, School of Medicine, University of Connecticut and Connecticut Children's Medical Center, Hartford, Connecticut.""}, {'ForeName': 'Nadav', 'Initials': 'N', 'LastName': 'Traeger', 'Affiliation': ""Division of Pediatric Pulmonology, Maria Fareri Children's Hospital, Valhalla, New York.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lahiri', 'Affiliation': 'Division of Pediatric Pulmonology, Larner College of Medicine, The University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Kremer', 'Affiliation': 'Pediatric Pulmonology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sheils', 'Affiliation': ""Department of Medicine, Harvard Medical School, Harvard University and Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Meyer', 'Affiliation': 'Division of Neonatology, Baystate Health Center, Springfield, Massachusetts.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Rosenkrantz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Connecticut Health, Farmington, Connecticut.'}, {'ForeName': 'Sankaran', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': ""Division of Pediatric Pulmonology, Maria Fareri Children's Hospital, Valhalla, New York.""}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Hartman', 'Affiliation': 'Division of Neonatology, Geisel School of Medicine, Dartmouth College, Manchester, New Hampshire.'}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts; and.""}, {'ForeName': 'Elie G', 'Initials': 'EG', 'LastName': 'Abu Jawdeh', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, College of Medicine, University of Kentucky, Lexington, Kentucky.'}]",Pediatrics,['10.1542/peds.2020-0079']
2525,32659641,A comparative study of autologous rectus fascia pubovaginal sling surgery and synthetic transobturator vaginal tape procedure in treatment of women with urodynamic stress urinary incontinence.,"OBJECTIVE


To compare short term results of autologous rectus fascia pubovaginal sling surgery with synthetic transobturator vaginal tape procedure in treatment of female stress urinary incontinence (SUI) STUDY DESIGN: It was a comparative study on 30 women between 25-65 years of age with urodynamic proven SUI who were randomly allocated to autologous rectus fascia pubovaginal sling surgery (Group I)(15 women) and synthetic transobturator vaginal tape procedure (Group II) (15 women). Preoperative and postoperative ICIQ (International Consultation on Incontinence Questionnaire) score, urodynamic study and serum CRP and IL-6 were done in all cases.
RESULTS


The baseline characteristics in terms of age, body mass index (BMI), parity, mean ICIQ score and mean preoperative CRP and IL-6 levels were similar in two groups. Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II. Mean hospital stay of 7.1 ± 1.2 vs 1.2 ± 0.4 days, mean duration of catheterization 5.8 vs 1.2 day (<0.01) and postoperative urinary retention requiring recathterization were all significantly higher in group I than II. Wound infection was more in group I than in group II (p = 0.01) while groin pain was significantly more in group II (p = 0.01). One patient developed vesicovaginal fistula, while one patient required cutting of tape in group I. Pdet at Q max (Detrusor pressure at peak urine flow) increased significantly in both the groups after surgery. ICIQ score was zero in both the groups indicating 100 % success. Surgical trauma was more in group I as shown by significantly higher CRP levels.
CONCLUSION


The success rate of the two groups was similar but, autologous rectus fascia sling surgery took longer, had more complications and urinary retention as compared to transobturator vaginal tape procedure.",2020,"Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II.","['Group II) (15 women', 'women with urodynamic stress urinary incontinence', '30 women between 25-65 years of age with urodynamic proven SUI', 'female stress urinary incontinence']","['autologous rectus fascia pubovaginal sling surgery (Group I)(15 women) and synthetic transobturator vaginal tape procedure', 'autologous rectus fascia pubovaginal sling surgery and synthetic transobturator vaginal tape procedure', 'autologous rectus fascia pubovaginal sling surgery with synthetic transobturator vaginal tape procedure']","['Preoperative and postoperative ICIQ ', 'Mean operative time', 'Mean hospital stay', 'ICIQ score', 'Surgical trauma', 'CRP and IL-6', 'Wound infection', 'postoperative urinary retention requiring recathterization', 'CRP levels', 'complications and urinary retention', 'groin pain', 'vesicovaginal fistula', 'mean duration of catheterization', 'success rate', 'body mass index (BMI), parity, mean ICIQ score and mean preoperative CRP and IL-6 levels', 'Incontinence Questionnaire) score, urodynamic study and serum']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0225234', 'cui_str': 'Structure of fascia of rectus abdominis muscle'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0042582', 'cui_str': 'Vesicovaginal fistula'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",30.0,0.0224989,"Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II.","[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: jbsharma@aiims.ac.in.'}, {'ForeName': 'Manasi Kamalakar', 'Initials': 'MK', 'LastName': 'Deoghare', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Kachhawa', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Mahey', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amlesh', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, New Delhi, India.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.062']
2526,32659699,A web-based daily care training to improve the quality of life of mothers of children with cerebral palsy: A randomized controlled trial.,"BACKGROUND


Mothers of moderately to severely affected children with cerebral palsy (CP) have to spend a long time to take care of their children. This time-consuming responsibility affects their physical and psychosocial health. Therefore, mothers as caregivers are required to receive special training to take care of their children.
AIMS


The aim of this study was to evaluate the effectiveness of a developed web-based intervention for daily care training of children with CP on their mothers' quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain.
METHODS AND PROCEDURES


This study was a single blind randomized controlled trial. 91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years were assigned to the intervention and control groups using block randomization. Mothers in the control group received their routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention. QOL, depression, anxiety, stress, and pain were measured before and after the intervention in both groups.
OUTCOMES AND RESULTS


The results of analysis of covariance showed that after controlling the mean score of pretest of pain, the mean score of post-tests in the intervention and control groups was significantly different (P < 0.05). The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
CONCLUSIONS AND IMPLICATIONS


Designed web-based intervention affects the caregivers' QOL and pain significantly. This intervention can be used to provide daily care training for mothers of children with CP.",2020,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","['91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years', 'mothers of children with cerebral palsy', 'Mothers of moderately to severely affected children with cerebral palsy (CP', 'mothers of children with CP', 'children with CP on their mothers']","['special training', 'A web-based daily care training', 'routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention']","['quality of life', 'QOL, depression, anxiety, stress, and pain', 'mean score of pretest of pain', 'quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain', 'mean scores of physical health and total QOL scores of post-tests']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",91.0,0.0560542,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Nobakht', 'Affiliation': 'Pediatric Neurorehabilitation Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rassafiani', 'Affiliation': 'Occupational Therapy Department, Faculty of Allied Health Sciences, Kuwait University, Kuwait. Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: mrassafiani@yahoo.com.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Social Determinants of Health Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Biosatistics Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103731']
2527,32659714,The effect of web-based training on life quality and spousal adjustment for women with breast cancer and their spouses.,"PURPOSE


The aim of the study was to examine the effects of web-based training that was structured in line with Roy's Adaptation Model on the ""life quality"" of women with breast cancer, and on the ""spousal adjustment"" of women and their spouses.
METHOD


The study used a pretest-posttest, quasi-experimental controlled group design and 83 women with breast cancer and their spouses were enrolled. The data were collected at baseline and again three months later using the Functional Assessment of Cancer Therapy-breast cancer scale and the Dyadic Adjustment Scale as data collection tools.
RESULTS


The average scores of life quality and agreement between spouses in the web-based training group were higher than in the control group. More specifically, the physical well-being (p=0.002), emotional well-being (p<0.001), functional well-being (p=0.001), breast cancer module scores (p<0.001) and dyadic cohesion (p=0.003) and dyadic consensus (p<0.001) sub-dimension scores of the women in the intervention group were higher than those in the control group in the third month. Similarly, the third month mean score of dyadic consensus (p<0.001) and affectional expression (p=0.023) of the spouses in the intervention group were higher than those in the control group.
CONCLUSIONS


The web-based training programme that was prepared by nurses in line with Roy's Adaptation Model improved the life quality and couples' adjustment in women with breast cancer. Web-based training can be used to improve patient care outcomes because of the continuity of training for women and their spouses.",2020,"Similarly, the third month mean score of dyadic consensus (p<0.001) and affectional expression (p=0.023) of the spouses in the intervention group were higher than those in the control group.
","['women with breast cancer', '83 women with breast cancer and their spouses were enrolled', 'women with breast cancer, and on the ""spousal adjustment"" of women and their spouses', 'women with breast cancer and their spouses']",['web-based training'],"['dyadic consensus (p<0.001) sub-dimension scores', 'life quality and spousal adjustment', 'Functional Assessment of Cancer Therapy-breast cancer scale and the Dyadic Adjustment Scale', 'life quality', 'average scores of life quality', 'emotional well-being (p<0.001), functional well-being (p=0.001), breast cancer module scores (p<0.001) and dyadic cohesion', 'mean score of dyadic consensus (p<0.001) and affectional expression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",83.0,0.0223756,"Similarly, the third month mean score of dyadic consensus (p<0.001) and affectional expression (p=0.023) of the spouses in the intervention group were higher than those in the control group.
","[{'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Çömez', 'Affiliation': 'Mehmet Akif Ersoy University, Faculty of Health Sciences, Department of Nursing, Burdur, Turkey. Electronic address: saadet.andic@gmail.com.'}, {'ForeName': 'Özgül', 'Initials': 'Ö', 'LastName': 'Karayurt', 'Affiliation': 'Izmir University of Economics, Faculty of Health Sciences, Department of Nursing, Izmir, Turkey.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101758']
2528,32659755,Prophylactic Ligature of AV Fistula Prevents High Output Heart Failure after Kidney Transplantation.,"BACKGROUND


Arteriovenous (AV) fistulas are considered the gold standard for ensuring safe and long-term vascular access in patients with haemodialysis-dependent end-stage renal disease. However, previous studies demonstrated that high-flow AV fistulas might add additional cardiovascular burden in the post-transplant setting, leading to frequent fistula closure in this population. Currently, there is no consensus regarding management of high-flow fistulas in post-transplant patients with stable kidney function. The present randomized controlled trial examines the effect of prophylactic AV fistula closure on high-output heart failure.
METHODS


Twenty-eight kidney transplant patients with stable graft function, absence of pre-existing severe cardiac failure, and brachial arterial flow rate of at least 1,500 mL/min were recruited and randomized in a 1:1 ratio to an intervention and control group, respectively. The intervention group was subject to immediate fistula ligature. Patients within the control group were referred to fistula ligature only if the main study endpoint high-output heart failure was reached. The latter was defined by the presence of at least 1 clinical sign (i.e., worsening NYHA score) and at least 2 of the following echocardiographic parameters: diameter of right atrium (major) >53 mm, right atrium (minor) >44 mm, inferior vena cava ≥21 mm, right pulmonary artery >20 mm, TAPSE <16 mm, systolic pulmonal artery pressure >40 mm Hg, and/or left ventricular eccentricity index <1. During a 24-month follow-up period, quarterly measurements of kidney function, NT-proBNP, and lactate dehydrogenase as well as a biannual echocardiographic check-up were performed.
RESULTS


High-output heart failure attributable to high-flow fistula was reported in 5 of 13 control patients (38.5%), whereas no patient in the intervention group presented with clinical and echocardiographic signs of high-output heart failure during the follow-up period. Thus, prophylactic ligature of high-flow fistulas avoided high-output heart failure in our patient population (p = 0.013). Three patients in the control group, however, had to undergo fistula ligature due to aneurysm formation (n = 2) and steal phenomenon (n = 1). Median NT-proBNP levels decreased from 317 ng/L pre-ligature to 223 ng/L post-ligature (p = 0.003). Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059). Improvement of echocardiographic findings (e.g., a decrease in systolic pulmonary arterial pressure) was found in 7 of 8 ligature patients but did not reach statistical significance.
CONCLUSION


Prophylactic ligature of high-flow AV fistulas after kidney transplantation can avoid high-output heart failure, and a more liberal approach to close AV fistulas might be justified.",2020,"Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059).","['patients with haemodialysis-dependent end-stage renal disease', 'Twenty-eight kidney transplant patients with stable graft function, absence of pre-existing severe cardiac failure, and brachial arterial flow rate of at least 1,500 mL/min', 'Kidney Transplantation', 'post-transplant patients with stable kidney function']","['prophylactic AV fistula closure', 'Prophylactic Ligature of AV Fistula']","['clinical and echocardiographic signs of high-output heart failure', 'Serum creatinine levels', 'systolic pulmonary arterial pressure', 'systolic pulmonal artery pressure', 'Median NT-proBNP levels', 'kidney function, NT-proBNP, and lactate dehydrogenase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0429856', 'cui_str': 'Arterial flow'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0023692', 'cui_str': 'Ligature'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0221045', 'cui_str': 'High output heart failure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",28.0,0.0372347,"Serum creatinine levels did not significantly differ before and after AV fistula ligature (1.69 vs. 1.60 mg/dL, respectively, p = 0.059).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hetz', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pirklbauer', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Department of Internal Medicine III - Cardiology and Angiology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Posch', 'Affiliation': 'Department for Surgery, University Hospital for Vascular Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gummerer', 'Affiliation': 'Department for Surgery, University Hospital for Vascular Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tiefenthaler', 'Affiliation': 'Department of Internal Medicine IV - Nephrology and Hypertension, Medical University Innsbruck, Innsbruck, Austria, martin.tiefenthaler@i-med.ac.at.'}]",American journal of nephrology,['10.1159/000508957']
2529,32659768,The Effect of Ostrich Oil as a Complementary Medicine on the Severity of Pruritus and Quality of Life in Hemodialysis Patients.,"INTRODUCTION


Pruritus is one of the most common problems in a uremic syndrome that reduces the quality of life due to the constant unpleasant feeling. The purpose of this study was to investigate the effect of ostrich oil massage on the severity of pruritus and quality of life in hemodialysis patients.
METHODS


In this study, 68 hemodialysis patients with pruritus were selected based on the available sampling method. The intervention group used 1 mL ostrich oil on the pruritus area for 10 min each night for 1 month. The control group received a placebo massage. Pruritus severity questionnaire-based itch severity scale and quality of life questionnaire were completed, respectively, at the end of each week and at the end of the period. Statistical analysis was done using SPSS software version 23 and applying on independent t test, paired t test, and analysis of covariance.
RESULTS


During the first and second weeks after the treatment, there was no statistical difference between the mean scores of pruritus severity in both groups (p > 0.05); however, in the third and fourth weeks after the treatment, the mean severity level of pruritus in the ostrich oil group was lower than in the placebo group, and these differences were statistically significant between the two groups (p < 0.05). There was no significant difference in quality of life between two groups of ostrich and placebo.
CONCLUSION


The use of ostrich oil was effective in reducing pruritus in hemodialysis patients. This method can be proposed as a complementary method for relieving pruritus in hemodialysis patients.",2020,"During the first and second weeks after the treatment, there was no statistical difference between the mean scores of pruritus severity in both groups (p > 0.05); however, in the third and fourth weeks after the treatment, the mean severity level of pruritus in the ostrich oil group was lower than in the placebo group, and these differences were statistically significant between the two groups (p < 0.05).","['Hemodialysis Patients', '68 hemodialysis patients with pruritus were selected based on the available sampling method', 'hemodialysis patients']","['Ostrich Oil', 'ostrich oil', 'ostrich oil massage', 'placebo massage', 'mL ostrich oil', 'placebo']","['quality of life', 'Severity of Pruritus and Quality of Life', 'mean scores of pruritus severity', 'severity of pruritus and quality of life', 'Pruritus severity questionnaire-based itch severity scale and quality of life questionnaire', 'mean severity level of pruritus']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}]","[{'cui': 'C0325336', 'cui_str': 'Struthio camelus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",68.0,0.032302,"During the first and second weeks after the treatment, there was no statistical difference between the mean scores of pruritus severity in both groups (p > 0.05); however, in the third and fourth weeks after the treatment, the mean severity level of pruritus in the ostrich oil group was lower than in the placebo group, and these differences were statistically significant between the two groups (p < 0.05).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sadeghnejad', 'Affiliation': 'School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Karampourian', 'Affiliation': 'Urology and Nephrology Research Center, Department of Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran, karampor1@yahoo.com.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Borzou', 'Affiliation': 'Urology and Nephrology Research Center, Department of Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Gholyaf', 'Affiliation': 'Department of Nephrology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Hadadi', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Complementary medicine research,['10.1159/000508288']
2530,32659784,Joint modeling and multiple comparisons with the best of data from a SMART with survival outcomes.,"A dynamic treatment regimen (DTR) is a sequence of decision rules that can alter treatments or doses based on outcomes from prior treatment. In the case of two lines of treatment, a DTR specifies first-line treatment, and second-line treatment for responders and treatment for non-responders to the first-line treatment. A sequential, multiple assignment, randomized trial (SMART) is one such type of trial that has been designed to assess DTRs. The primary goal of our project is to identify the treatments, covariates, and their interactions result in the best overall survival rate. Many previously proposed methods to analyze data with survival outcomes from a SMART use inverse probability weighting and provide non-parametric estimation of survival rates, but no other information. Other methods have been proposed to identify and estimate the optimal DTR, but inference issues were seldom addressed. We apply a joint modeling approach to provide unbiased survival estimates as a mechanism to quantify baseline and time-varying covariate effects, treatment effects, and their interactions within regimens. The issue of multiple comparisons at specific time points is addressed using multiple comparisons with the best method.",2020,A dynamic treatment regimen (DTR) is a sequence of decision rules that can alter treatments or doses based on outcomes from prior treatment.,[],[],"['overall survival rate', 'survival rates']",[],[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0402275,A dynamic treatment regimen (DTR) is a sequence of decision rules that can alter treatments or doses based on outcomes from prior treatment.,"[{'ForeName': 'Yan-Cheng', 'Initials': 'YC', 'LastName': 'Chao', 'Affiliation': ''}, {'ForeName': 'Qui', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': 'Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320-1799, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Tsodikov', 'Affiliation': 'Department of Biostatistics, University of Michigan, 1415 Washington Heights, Ann Arbor, MI 48109-2029, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, University of Michigan, 1415 Washington Heights, Ann Arbor, MI 48109-2029, USA.'}]","Biostatistics (Oxford, England)",['10.1093/biostatistics/kxaa025']
2531,32659919,A Gluten-Free Meal Produces a Lower Postprandial Thermogenic Response Compared to an Iso-Energetic/Macronutrient Whole Food or Processed Food Meal in Young Women: A Single-Blind Randomized Cross-Over Trial.,"Consumption of ultra-processed food (PF) is associated with obesity risk compared with whole food (WF) intake. Less is known regarding the intake of gluten-free (GF) food products. The purpose of this study was to directly compare the thermic effect (TEM), substrate utilization, hunger/taste ratings, and glucose response of three different meals containing PF, WF, and GF food products in young healthy women. Eleven volunteers completed all three iso-caloric/macronutrient test meals in a single-blind, randomized crossover design: (1) whole food meal (WF); (2) processed food meal (PF); or (3) gluten-free meal (GF). TEM was significantly lower following GF compared with WF (-20.94 kcal/meal, [95% CI, -35.92 to -5.96],  p  = 0.008) and PF (mean difference: -14.94 kcal/meal, [95% CI, -29.92 to 0.04],  p  = 0.04), respectively. WF consumption resulted in significantly higher feelings of fullness compared to GF (mean difference: +14.36%, [95% CI, 3.41 to 25.32%],  p  = 0.011) and PF (mean difference: +16.81%, [95% CI, 5.62 to 28.01%],  p  = 0.004), respectively, and enhanced palatability (taste of meal) compared to PF meal (mean Δ: +27.41%, [95% CI, 5.53 to 49.30%],  p  = 0.048). No differences existed for substrate utilization and blood glucose response among trials. Consumption of a GF meal lowers postprandial thermogenesis compared to WF and PF meals and fullness ratings compared to a WF meal which may impact weight control and obesity risk over the long-term.",2020,"WF consumption resulted in significantly higher feelings of fullness compared to GF (mean difference: +14.36%, [95% CI, 3.41 to 25.32%],  p  = 0.011) and PF (mean difference: +16.81%, [95% CI, 5.62 to 28.01%],  p  = 0.004), respectively, and enhanced palatability (taste of meal) compared to PF meal (mean Δ: +27.41%, [95% CI, 5.53 to 49.30%],  p  = 0.048).","['Eleven volunteers', 'young healthy women', 'Young Women']","['whole food meal (WF); (2) processed food meal (PF); or (3) gluten-free meal (GF', 'ultra-processed food (PF', 'GF meal', 'Energetic/Macronutrient Whole Food or Processed Food Meal']","['substrate utilization and blood glucose response', 'Postprandial Thermogenic Response', 'TEM', 'PF', 'feelings of fullness', 'enhanced palatability (taste of meal', 'fullness ratings', 'postprandial thermogenesis', 'thermic effect (TEM), substrate utilization, hunger/taste ratings, and glucose response']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",11.0,0.0721658,"WF consumption resulted in significantly higher feelings of fullness compared to GF (mean difference: +14.36%, [95% CI, 3.41 to 25.32%],  p  = 0.011) and PF (mean difference: +16.81%, [95% CI, 5.62 to 28.01%],  p  = 0.004), respectively, and enhanced palatability (taste of meal) compared to PF meal (mean Δ: +27.41%, [95% CI, 5.53 to 49.30%],  p  = 0.048).","[{'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Dioneda', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Healy', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Sheridan', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Alex E', 'Initials': 'AE', 'LastName': 'Mohr', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85281, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Arciero', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]",Nutrients,['10.3390/nu12072035']
2532,32659982,"Breakfast Consumption in Low-Income Hispanic Elementary School-Aged Children: Associations with Anthropometric, Metabolic, and Dietary Parameters.","Breakfast consumption is associated with lower obesity prevalence and cardiometabolic risk and higher dietary quality (DQ) in children. Low-income, Hispanic populations are disproportionately affected by obesity and cardiometabolic risks. This study examined the relationship between breakfast consumption groups (BCG) on anthropometric, metabolic, and dietary parameters in predominately low-income, Hispanic children from 16 Texas schools. Cross-sectional data were from TX Sprouts, a school-based gardening, nutrition, and cooking randomized controlled trial. Anthropometric measurements included height, weight, body mass index, body fat percent via bioelectrical impedance, waist circumference, and blood pressure. Metabolic parameters included fasting plasma glucose, insulin, glycated hemoglobin, cholesterol, and triglycerides. DQ and BCG were assessed via two 24-h dietary recalls. Multivariate multiple regression examined relationships between BCG and anthropometric, metabolic, and dietary parameters. This study included 671 students (mean age 9 years, 58% Hispanic, 54% female, 66% free/reduced lunch, 17% breakfast skippers). No relationships were observed between BCG and anthropometric or metabolic parameters. BCG had higher DQ; higher daily protein, total sugar, and added sugar intake; and lower daily fat intake. Skipping breakfast was associated with lower DQ; higher daily fat intake; and lower daily protein intake. Longitudinal research examining breakfast quality on cardiometabolic outcomes in low-income, Hispanic children is warranted.",2020,Breakfast consumption is associated with lower obesity prevalence and cardiometabolic risk and higher dietary quality (DQ) in children.,"['671 students (mean age 9 years, 58% Hispanic, 54% female, 66% free/reduced lunch, 17% breakfast skippers', 'predominately low-income, Hispanic children from 16 Texas schools', 'children', 'Low-Income Hispanic Elementary School-Aged Children', 'low-income, Hispanic children']","['breakfast consumption groups (BCG', 'Breakfast Consumption']","['lower obesity prevalence and cardiometabolic risk and higher dietary quality (DQ', 'anthropometric, metabolic, and dietary parameters', 'height, weight, body mass index, body fat percent via bioelectrical impedance, waist circumference, and blood pressure', 'BCG and anthropometric or metabolic parameters', 'DQ; higher daily protein, total sugar, and added sugar intake; and lower daily fat intake', 'DQ and BCG', 'fasting plasma glucose, insulin, glycated hemoglobin, cholesterol, and triglycerides']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",671.0,0.0198321,Breakfast consumption is associated with lower obesity prevalence and cardiometabolic risk and higher dietary quality (DQ) in children.,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, 200 W 24th Street, Stop A2700, Austin, TX 78712, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, 200 W 24th Street, Stop A2700, Austin, TX 78712, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, 200 W 24th Street, Stop A2700, Austin, TX 78712, USA.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, 200 W 24th Street, Stop A2700, Austin, TX 78712, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, 200 W 24th Street, Stop A2700, Austin, TX 78712, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leidy', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, 200 W 24th Street, Stop A2700, Austin, TX 78712, USA.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, 200 W 24th Street, Stop A2700, Austin, TX 78712, USA.'}]",Nutrients,['10.3390/nu12072038']
2533,32660010,"The Effect of  Lactobacillus acidophilus  YT1 (MENOLACTO) on Improving Menopausal Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.","This study evaluated the efficacy of  Lactobacillus acidophilus  YT1 (MENOLACTO) for alleviating menopausal symptoms. This study was a multi-center, randomized, double-blinded, placebo-controlled clinical trial involving female subjects (ages: 40-60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20. Subjects were administered 1 × 10 8  CFU/day MENOLACTO or placebo, with the primary endpoint being total KMI score, and the effect of secondary endpoints on alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire). After 12 weeks, total KMI scores decreased significantly, demonstrating improved menopausal symptoms relative to placebo along with improved modified KMI scores. Additionally, quality of life, according to the MENQOL questionnaire, significantly improved in all four symptoms-physical, psychosocial, vasomotor, and sexual symptoms. Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness. These results demonstrated that MENOLACTO alleviated menopausal symptoms without notable side effects and improved quality of life, suggesting its efficacy as an alternative supplement to alleviate menopausal symptoms in women ineligible for hormonal therapy.",2020,"Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness.",['female subjects (ages: 40-60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20'],"['Lactobacillus acidophilus  YT1 (MENOLACTO', 'Placebo', 'placebo']","['quality of life', 'quality of life, according to the MENQOL questionnaire', 'alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire', 'Menopausal Symptoms', 'total KMI scores', 'blood follicle-stimulating hormone and estradiol levels or endometrial thickness', 'symptoms-physical, psychosocial, vasomotor, and sexual symptoms', 'total KMI score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0857249', 'cui_str': 'Blood follicle stimulating hormone'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom'}]",,0.446017,"Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness.","[{'ForeName': 'Eun Yeong', 'Initials': 'EY', 'LastName': 'Lim', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Hee Soon', 'Initials': 'HS', 'LastName': 'Shin', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Jaekwang', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Young-Do', 'Initials': 'YD', 'LastName': 'Nam', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Dong Ock', 'Initials': 'DO', 'LastName': 'Lee', 'Affiliation': 'Center for Gynecologic Cancer, National Cancer Center Korea, Goyang-si 10408, Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Konkuk University Hospital, Konkuk University School of Medicine, Seoul 05030, Korea.'}, {'ForeName': 'Sung Hum', 'Initials': 'SH', 'LastName': 'Yeon', 'Affiliation': 'R&D Center, Huons Co., Ltd., Ansan 15588, Korea.'}, {'ForeName': 'Rak Ho', 'Initials': 'RH', 'LastName': 'Son', 'Affiliation': 'R&D Center, Huons Co., Ltd., Ansan 15588, Korea.'}, {'ForeName': 'Chae Lee', 'Initials': 'CL', 'LastName': 'Park', 'Affiliation': 'R&D Center, Huons Co., Ltd., Ansan 15588, Korea.'}, {'ForeName': 'Yun Haeng', 'Initials': 'YH', 'LastName': 'Heo', 'Affiliation': 'Clinical Operation Team, Huons Co., Ltd., Seongnam-si 13486, Korea.'}, {'ForeName': 'Yun Tai', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Division of Food Functionality Research, Korea Food Research Institute, Wanju 55365, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9072173']
2534,32660025,Targeting the Intestinal Microbiota to Prevent Type 2 Diabetes and Enhance the Effect of Metformin on Glycaemia: A Randomised Controlled Pilot Study.,"Early treatment may prevent or delay the onset of type 2 diabetes mellitus (T2DM) in individuals who are at high risk. Lifestyle interventions and the hypoglycemic drug metformin have been shown to reduce T2DM incidence. The effectiveness of such interventions may be enhanced by targeting environmental factors such as the intestinal microbiota, which has been proven to predict the response to lifestyle interventions and play a part in mediating the glucose-lowering effects of metformin. Shifts in the intestinal microbiota ""towards a more balanced state"" may promote glucose homeostasis by regulating short-chain fatty acids' production. This study aimed to investigate the safety and effect of a multi-strain probiotic on glycemic, inflammatory, and permeability markers in adults with prediabetes and early T2DM and to assess whether the probiotic can enhance metformin's effect on glycaemia. A randomised controlled pilot study was conducted in 60 adults with a BMI ≥ 25 kg/m 2  and with prediabetes or T2DM (within the previous 12 months). The participants were randomised to a multi-strain probiotic ( L. plantarum ,  L. bulgaricus ,  L. gasseri ,  B. breve ,  B. animalis sbsp. lactis ,  B. bifidum ,  S. thermophilus , and  S. boulardii ) or placebo for 12 weeks. Analyses of the primary outcome (fasting plasma glucose) and secondary outcomes, including, but not limited to, circulating lipopolysaccharide, zonulin, and short chain fatty acids and a metagenomic analysis of the fecal microbiome were performed at baseline and 12 weeks post-intervention. The results showed no significant differences in the primary and secondary outcome measures between the probiotic and placebo group. An analysis of a subgroup of participants taking metformin showed a decrease in fasting plasma glucose, HbA1c, insulin resistance, and zonulin; an increase in plasma butyrate concentrations; and an enrichment of microbial butyrate-producing pathways in the probiotic group but not in the placebo group. Probiotics may act as an adjunctive to metformin by increasing the production of butyrate, which may consequently enhance glucose management.",2020,"Shifts in the intestinal microbiota ""towards a more balanced state"" may promote glucose homeostasis by regulating short-chain fatty acids' production.","['individuals who are at high risk', 'adults with prediabetes and early T2DM', '60 adults with a BMI ≥ 25 kg/m']","['multi-strain probiotic', 'Metformin', 'multi-strain probiotic ( L. plantarum ,  L. bulgaricus ,  L. gasseri ,  B. breve ,  B. animalis sbsp', 'metformin', 'T2DM', 'placebo']","['T2DM incidence', 'plasma butyrate concentrations', 'glycemic, inflammatory, and permeability markers', 'primary outcome (fasting plasma glucose) and secondary outcomes, including, but not limited to, circulating lipopolysaccharide, zonulin, and short chain fatty acids and a metagenomic analysis of the fecal microbiome', 'fasting plasma glucose, HbA1c, insulin resistance, and zonulin']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",60.0,0.109416,"Shifts in the intestinal microbiota ""towards a more balanced state"" may promote glucose homeostasis by regulating short-chain fatty acids' production.","[{'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Palacios', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vitetta', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Coulson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Claire D', 'Initials': 'CD', 'LastName': 'Madigan', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Yan Y', 'Initials': 'YY', 'LastName': 'Lam', 'Affiliation': 'Department of Biochemistry and Microbiology and New Jersey Institute for Food, Nutrition, and Health, School of Environmental and Biological Sciences, Rutgers University, New Brunswick, NJ 08901, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manuel', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW 2052, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Briskey', 'Affiliation': 'School of Human Movement and Nutrition Sciences, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD 4072, Australia.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Hendy', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Ji-Nu', 'Initials': 'JN', 'LastName': 'Kim', 'Affiliation': 'Solarea Bio Inc., Cambridge, MA 02142, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ishoey', 'Affiliation': 'Solarea Bio Inc., Cambridge, MA 02142, USA.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Soto-Giron', 'Affiliation': 'Solarea Bio Inc., Cambridge, MA 02142, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Schott', 'Affiliation': 'Solarea Bio Inc., Cambridge, MA 02142, USA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Toledo', 'Affiliation': 'Solarea Bio Inc., Cambridge, MA 02142, USA.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, Australia.'}]",Nutrients,['10.3390/nu12072041']
2535,32660282,Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1.,"OBJECTIVES


To evaluate the efficacy of guselkumab through four years of continuous treatment for psoriasis.
METHODS


In the phase 3 VOYAGE 1 trial, 837 patients with moderate-to-severe psoriasis were randomized to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab 40 mg every-2-weeks. Patients in the placebo and adalimumab groups crossed over to receive guselkumab at weeks 16/52, respectively; eligible patients received open-label guselkumab through week 204. Efficacy endpoints (i.e., PASI 75/90/100, IGA 0/1, and IGA 0) were analyzed in the guselkumab group using different methodologies: prespecified treatment failure rules (TFR, patients discontinued due to lack of efficacy, psoriasis worsening, or protocol-prohibited psoriasis treatment considered nonresponders); nonresponder imputation (NRI, patients with missing data counted as nonresponders); and As Observed (OBS, no imputation). Safety was evaluated through week 204.
RESULTS


At week 204, PASI 90 response rates were 82.2%, 68.4%, and 84.3%, respectively, based on TFR, NRI, and OBS analyses; corresponding proportions at week 52 were 79.7%, 75.5%, and 80.6%. Similarly, PASI 75, PASI 100, IGA 0/1, and IGA 0 responses were maintained from week 52 through week 204. No new safety signals were identified.
CONCLUSIONS


High efficacy response rates were maintained through four years of continuous guselkumab treatment for psoriasis.",2020,"Patients in the placebo and adalimumab groups crossed over to receive guselkumab at weeks 16/52, respectively; eligible patients received open-label guselkumab through week 204.","['837 patients with moderate-to-severe psoriasis', 'patients with moderate-to-severe psoriasis', 'psoriasis']","['open-label guselkumab', 'placebo and adalimumab', 'guselkumab 100\u2009mg every-8-weeks, placebo, or adalimumab 40\u2009mg every-2-weeks', 'guselkumab']","['Safety', 'PASI 90 response rates', 'efficacy response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",837.0,0.0338056,"Patients in the placebo and adalimumab groups crossed over to receive guselkumab at weeks 16/52, respectively; eligible patients received open-label guselkumab through week 204.","[{'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, UK.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Research, Inc, Waterloo, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Yaung-Kaung', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1782817']
2536,32660299,Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study.,"OBJECTIVE


Low-dose testosterone has been shown to improve depression symptom severity, fatigue, and sexual function in small studies in women not formally diagnosed with major depressive disorder. The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depression symptom severity, fatigue, and sexual function in women with antidepressant-resistant major depression. A functional MRI (fMRI) substudy examined effects on activity in the anterior cingulate cortex (ACC), a brain region important in mood regulation.
METHODS


The authors conducted an 8-week randomized double-blind placebo-controlled trial of adjunctive testosterone cream in 101 women, ages 21-70, with antidepressant-resistant major depression. The primary outcome measure was depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints included fatigue, sexual function, and safety measures. The primary outcome of the fMRI substudy (N=20) was change in ACC activity.
RESULTS


The participants' mean age was 47 years (SD=14) and their mean baseline MADRS score was 26.6 (SD=5.9). Eighty-seven (86%) participants completed 8 weeks of treatment. MADRS scores decreased in both study arms from baseline to week 8 (testosterone arm: from 26.8 [SD=6.3] to 15.3 [SD=9.6]; placebo arm: from 26.3 [SD=5.4] to 14.4 [SD=9.3]), with no significant difference between groups. Improvement in fatigue and sexual function did not differ between groups, nor did side effects. fMRI results showed a relationship between ACC activation and androgen levels before treatment but no difference in ACC activation with testosterone compared with placebo.
CONCLUSIONS


Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction. Imaging in a subset of participants demonstrated that testosterone did not result in greater activation of the ACC.",2020,"CONCLUSIONS


Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction.","['women with antidepressant-resistant major depression', 'women not formally diagnosed with major depressive disorder', '101 women, ages 21-70, with antidepressant-resistant major depression', 'Antidepressant-Resistant Major Depressive Disorder in Women']","['Placebo', 'testosterone', 'adjunctive testosterone cream', 'Low-Dose Testosterone Augmentation', 'adjunctive low-dose transdermal testosterone', 'placebo']","['fatigue and sexual function', 'ACC activation and androgen levels', 'ACC activation', 'ACC activity', 'depression symptom severity, fatigue, and sexual function', 'MADRS scores', 'mean baseline MADRS score', 'depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS', 'fatigue, sexual function, and safety measures', 'symptoms of depression, fatigue, or sexual dysfunction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]",101.0,0.641546,"CONCLUSIONS


Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Dichtel', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Carpenter', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Nyer', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kimball', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Darin D', 'Initials': 'DD', 'LastName': 'Dougherty', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dording', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Nhi-Ha', 'Initials': 'NH', 'LastName': 'Trinh', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Pedrelli', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Farabaugh', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Shapero', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Cassano', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Hahn', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Rao', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Roscoe O', 'Initials': 'RO', 'LastName': 'Brady', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Ravinder J', 'Initials': 'RJ', 'LastName': 'Singh', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Tyrka', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Price', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}, {'ForeName': 'Karen K', 'Initials': 'KK', 'LastName': 'Miller', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dichtel, Kimball, Miller); Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Nyer, Mischoulon, Deckersbach, Dougherty, Yeung, Cassano, Hahn, Farabaugh, Pedrelli, Trinh, Dording, Cusin, Papakostas, Chang, Fisher, Shapero, Chen, Fava); Department of Psychiatry, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston (Brady); Biostatistics Center, Massachusetts General Hospital, Boston (Schoenfeld); Butler Hospital and Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Medicine, Brown University, Providence, R.I. (Carpenter, Tyrka, Price); Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston (Rao); Mayo Clinic Endocrine Laboratory, Rochester, Minn. (Singh).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2020.19080844']
2537,32660329,Introducing a forced choice recognition trial to the Hopkins Verbal Learning Test - Revised.,"OBJECTIVE


This study was designed to replicate previous research on embedded validity indicators (EVIs) in the Hopkins Verbal Learning Test - Revised (HVLT-R) and introduce a new forced choice recognition trial (FCR).
METHOD


Undergraduate research volunteers were randomly assigned ( M   Age  = 21.7;  M   Education  = 14.5 years, 85% female) to either the control or experimental malingering condition, and were administered a brief battery of neuropsychological tests.
RESULTS


Recognition memory based EVIs (both existing and newly introduced) effectively discriminated credible and non-credible response sets. An FCR ≤11 produced .59 sensitivity and perfect specificity to invalid responding. A Recognition Discrimination (RD) score ≤8 also produced a good combination of sensitivity (.35) and specificity (.96). The FCR trial made unique contributions to performance validity assessment above and beyond previously published EVIs.
CONCLUSIONS


RD achieved ≥.90 specificity at higher cutoffs than previously reported. The newly introduced FCR trial has the potential to enhance the existing arsenal of EVIs within the HVLT-R. However, it must demonstrate its ability to differentiate genuine impairment from non-credible responding before it can be recommended for clinical use.",2020,"RESULTS


Recognition memory based EVIs (both existing and newly introduced) effectively discriminated credible and non-credible response sets.","['Undergraduate research volunteers were randomly assigned ( M   Age  = 21.7;  M   Education  = 14.5\u2009years, 85% female) to either the']","['control or experimental malingering condition', 'Hopkins Verbal Learning Test - Revised (HVLT-R']",['A Recognition Discrimination (RD) score'],"[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024630', 'cui_str': 'Malingering'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0297511,"RESULTS


Recognition memory based EVIs (both existing and newly introduced) effectively discriminated credible and non-credible response sets.","[{'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Abeare', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hurtubise', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cutler', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sirianni', 'Affiliation': 'School of Social Work, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Maame', 'Initials': 'M', 'LastName': 'Brantuo', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Nadeen', 'Initials': 'N', 'LastName': 'Makhzoum', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Laszlo A', 'Initials': 'LA', 'LastName': 'Erdodi', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}]",The Clinical neuropsychologist,['10.1080/13854046.2020.1779348']
2538,32660347,Effects of Transcranial Direct Current Stimulation Over the Dorsolateral Prefrontal Cortex (PFC) on Cognitive-Motor Dual Control Skills.,"This randomized crossover study investigated whether anodal transcranial direct current stimulation (tDCS) over the dorsolateral prefontal cortex (dlPFC) modulates memory-guided finger isometric maintenance during single motor and dual cognitive-motor tasks, based on electroencephalogram (EEG) signals. Twenty-three healthy participants (14 female;  M  age = 29.130 years,  SD  = 10.918) underwent both sham and 2-mA stimulation sessions over the dlPFC for 20 minutes, with a minimum washout period of seven days. We analyzed finger-force isometric maintenance and event-related spectral perturbation (ERSP) of the EEG during early and later phases of both tasks. We observed a significant motor accuracy improvement ( p  = .014) and significant variation of force output ( p  = .027) with significant decrease in ERSP on the dorsomedial prefrontal cortex (dmPFC) (early phase,  p  = .027; later phase,  p  = .023) only after 2 mA stimulation. Thus, anodal tDCS over the dlPFC may improve memory-guided force control during cognitive-motor dual tasks.",2020,"We observed a significant motor accuracy improvement ( p  = .014) and significant variation of force output ( p  = .027) with significant decrease in ERSP on the dorsomedial prefrontal cortex (dmPFC) (early phase,  p  = .027; later phase,  p  = .023) only after 2 mA stimulation.","['Twenty-three healthy participants (14 female;  M  age\u2009=\u200929.130 years,  SD \u2009=\u200910.918) underwent both']","['sham and 2-mA stimulation sessions', 'Transcranial Direct Current Stimulation', 'anodal transcranial direct current stimulation (tDCS']","['motor accuracy improvement', 'ERSP on the dorsomedial prefrontal cortex (dmPFC', 'force output']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",23.0,0.0297066,"We observed a significant motor accuracy improvement ( p  = .014) and significant variation of force output ( p  = .027) with significant decrease in ERSP on the dorsomedial prefrontal cortex (dmPFC) (early phase,  p  = .027; later phase,  p  = .023) only after 2 mA stimulation.","[{'ForeName': 'JaeHyuk', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Major in Rehabilitation Science, Graduate School, Korea University.'}, {'ForeName': 'SungHee', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'Department of Brain and Cognitive Engineering, Korea University.'}, {'ForeName': 'JiChai', 'Initials': 'J', 'LastName': 'Jeong', 'Affiliation': 'Department of Brain and Cognitive Engineering, Korea University.'}, {'ForeName': 'BumChul', 'Initials': 'B', 'LastName': 'Yoon', 'Affiliation': 'Major in Rehabilitation Science, Graduate School, Korea University.'}]",Perceptual and motor skills,['10.1177/0031512520935695']
2539,32660350,The Possession of High Status Strengthens the Status Motive.,"The current research tested whether the possession of high status, compared with the possession of low status, makes individuals desire having high status even more. Five studies (total  N  = 6,426), four of which were preregistered, supported this hypothesis. Individuals with higher status in their social groups or who were randomly assigned to a high-status condition were more motivated to have high status than were individuals with low status. Furthermore, upper-class individuals had a stronger status motive than working-class individuals, in part, due to their high status. High-status individuals had a stronger status motive, in part, because they were more confident in their ability to achieve (or retain) high status, but not because of other possible mechanisms (e.g., task self-efficacy). These findings provide a possible explanation for why status hierarchies are so stable and why inequality rises in social collectives over time.",2020,These findings provide a possible explanation for why status hierarchies are so stable and why inequality rises in social collectives over time.,['Individuals with higher status in their social groups'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0687744', 'cui_str': 'Social group'}]",[],[],,0.0120696,These findings provide a possible explanation for why status hierarchies are so stable and why inequality rises in social collectives over time.,"[{'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'John Angus D', 'Initials': 'JAD', 'LastName': 'Hildreth', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Daron L', 'Initials': 'DL', 'LastName': 'Sharps', 'Affiliation': 'University of California, Berkeley, USA.'}]",Personality & social psychology bulletin,['10.1177/0146167220937544']
2540,32665529,Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend.,"OBJECTIVE


Fracture risk increases with age, but few studies focus on persons ≥80 years. In the ACTIVE trial, treatment with abaloparatide for 18 months reduced osteoporotic fracture risk and increased bone mineral density. These effects were maintained with 24 months alendronate treatment in ACTIVExtend. We postulated that similar improvements in bone mineral density and safety would be demonstrated in women ≥80 years.
METHODS


Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
RESULTS


In total, 56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study. Mean age was 83.3 years; other baseline characteristics were similar. At the end of ACTIVE, bone mineral density increased at all sites for abaloparatide versus placebo. Bone mineral density increased in parallel in both groups during alendronate therapy (19 to 43 months) in ACTIVExtend. At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck. Fracture incidence was low and did not differ significantly between groups. Sequential treatment with abaloparatide followed by alendronate was well tolerated; the proportion of participants reporting adverse events was similar between groups.
CONCLUSIONS


Sequential treatment with abaloparatide followed by alendronate (43 months follow-up) in this small subgroup of ACTIVExtend participants suggests abaloparatide is well tolerated and effective in women aged ≥80 years. : Video Summary:http://links.lww.com/MENO/A618.",2020,"At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck.","['56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study', 'persons ≥80 years', 'women ≥80 years', 'women ≥80 years with osteoporosis', 'women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend', 'women aged ≥80 years']","['Abaloparatide followed by alendronate', 'alendronate', ' Video Summary:http://links.lww.com/MENO/A618', 'placebo/alendronate', 'placebo']","['bone mineral density', 'bone mineral density and safety', 'tolerated; the proportion of participants reporting adverse events', 'Bone mineral density', 'osteoporotic fracture risk and increased bone mineral density', 'Fracture incidence', 'bone mineral density and fracture incidence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029464', 'cui_str': 'Osteosclerosis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",56.0,0.236803,"At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck.","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lorraine A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Deal', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001593']
2541,32665531,TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial.,"OBJECTIVE


The aim of the study was to evaluate the clinically meaningful effect of oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules on hot flushes severity (vasomotor symptoms [VMS] severity scale) using the patient-reported Clinical Global Impression (CGI).
METHODS


REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial that evaluated TX-001HR in postmenopausal women (40-65 y) with a uterus. Those with frequent moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized in a VMS substudy to daily E2/P4 (1/100, 0.5/100, 0.5/50, or 0.25/50 mg/mg), or placebo. Patients rated VMS severity from 1 (mild) to 3 (severe) and symptom improvements with the CGI. CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
RESULTS


In the VMS substudy (n = 726), determined CID and minimal CID severity thresholds were reductions of 0.525 and 0.350 points at week 4, respectively, and 0.775 and 0.225 points at week 12. Significantly more women taking the two highest E2/P4 doses (1/100 and 0.5/100) versus placebo met CID severity thresholds at weeks 4 (40% and 44% vs 17%; P < 0.05) and 12 (56% and 48% vs 29%; P < 0.05).
CONCLUSION


REPLENISH trial data demonstrated that E2/P4 1/100 and 0.5/100 provided clinically meaningful improvements in hot flushes severity in postmenopausal women. In conjunction with previously demonstrated clinically meaningful VMS frequency improvements, these data support oral E2/P4 1/100 and 0.5/100 for postmenopausal women with a uterus seeking treatment for moderate to severe VMS.",2020,"CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
","['postmenopausal women (40-65 y) with a uterus', 'Those with frequent moderate to severe hot flushes (≥7/d or ≥50/wk', 'postmenopausal women', 'postmenopausal women with a uterus seeking treatment for moderate to severe VMS']","['TX-001HR', 'oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules', 'placebo']","['hot flushes severity (vasomotor symptoms [VMS] severity scale', 'CID and minimal CID severity thresholds', 'CID severity thresholds', 'VMS severity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.432405,"CGI results were an anchor in a nonparametric discriminant analysis to define clinically important differences (CIDs) and minimal CID in VMS severity at weeks 4 and 12.
","[{'ForeName': 'Ginger D', 'Initials': 'GD', 'LastName': 'Constantine', 'Affiliation': 'EndoRheum Consultants, LLC, Malvern, PA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'IntimMedicine Specialists, Washington, DC.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Pickar', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Revicki', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001602']
2542,32665656,The effect of epinephrine on the perfusion index during ultrasound-guided supraclavicular brachial plexus block: a randomized controlled trial.,"The perfusion index (PI) is an objective tool used to assess a successful nerve block. Epinephrine is a widely used adjuvant to local anesthetics, and it may affect PI values because of the vasoconstrictive property. The aim of this study was to investigate the influence of epinephrine on PI as an indicator of a successful block in ultrasound-guided supraclavicular brachial plexus block (SCBPB). In this randomized controlled trial, 82 adult patients underwent upper limb surgery under SCBPB were recruited between July 2018 and March 2019 in a single tertiary care center. Participants were randomly assigned to one of two groups: non-epinephrine group (n = 41) or epinephrine group (5 mcg ml -1 , n = 41). The primary outcome was the comparison of the ""PI ratio 10,"" which was defined as the ratio of the PI 10 to the baseline. Receiver operating characteristic (ROC) curves were constructed to determine the accuracy of the PI in predicting the block success at each time interval. The PI ratio 10 was 2.7 (1.9-4.0) in non-epinephrine group and 3.3 (2.2-4.4) in epinephrine group (median difference: 0.4; 95% confidence interval [CI] - 1.1 to 0.2; P = 0.207). The ROC curves compared without group identification were not significantly different over time. The cut-off value for the PI and PI ratio at 5 min (PI ratio 5) were 7.7 (area under the ROC [AUROC]: 0.89, 95% CI 0.83-0.94) and 1.6 (AUROC: 0.94, 95% CI 0.90-0.98), respectively. The perineural epinephrine did not affect the PI following a SCBPB. The PI ratio 5 > 1.6 might be considered as a relatively accurate predictor of a successful SCBPB.Trial registration: This study was registered at the Clinical Trial Registry of Korea (https://cris.nih.go.kr. CriS No. KCT0003006).",2020,The PI ratio 10 was 2.7 (1.9-4.0) in non-epinephrine group and 3.3 (2.2-4.4) in epinephrine group (median difference: 0.4; 95% confidence interval [CI] - 1.1 to 0.2; P = 0.207).,"['ultrasound-guided supraclavicular brachial plexus block', '82 adult patients underwent upper limb surgery under SCBPB were recruited between July 2018 and March 2019 in a single tertiary care center']","['CriS', 'Epinephrine', 'epinephrine']","['perfusion index', 'ROC curves', 'perfusion index (PI', 'comparison of the ""PI ratio 10,"" which was defined as the ratio of the PI 10 to the baseline', 'PI ratio 10', 'cut-off value for the PI and PI ratio']","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",82.0,0.235258,The PI ratio 10 was 2.7 (1.9-4.0) in non-epinephrine group and 3.3 (2.2-4.4) in epinephrine group (median difference: 0.4; 95% confidence interval [CI] - 1.1 to 0.2; P = 0.207).,"[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Ji Seon', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Min Jong', 'Initials': 'MJ', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Justin Sangwook', 'Initials': 'JS', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. jsko@skku.edu.'}]",Scientific reports,['10.1038/s41598-020-68475-4']
2543,32660604,Effects of virtual reality associated with serious games for upper limb rehabilitation inpatients with multiple sclerosis: randomized controlled trial.,"BACKGROUND


Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.
METHODS


A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of 1 month without receiving any treatment.
RESULTS


In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side.
CONCLUSIONS


An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.
TRIAL REGISTRATION


This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908 , Nov 2019.",2020,"An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.
","['upper limb rehabilitation inpatients with multiple sclerosis', 'patients with multiple sclerosis (MS']","['virtual reality associated with serious games', 'serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL', 'LMC based Serious Games designed for UL rehabilitation', 'Leap Motion Controller (LMC']","['unilateral gross manual dexterity, fine manual dexterity, and coordination', 'post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity', 'Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance', 'follow-up in coordination, speed of movements, fine and gross for the more affected side', 'UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance']","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",,0.0783139,"An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.
","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Cuesta-Gómez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sánchez-Herrera-Baeza', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain. patricia.sanchezherrera@urjc.es.'}, {'ForeName': 'Edwin Daniel', 'Initials': 'ED', 'LastName': 'Oña-Simbaña', 'Affiliation': 'Robotics Lab. University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Martínez-Medina', 'Affiliation': 'Asociación de Esclerosis Múltiple de Toledo (ADEMTO), Toledo, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ortiz-Comino', 'Affiliation': 'Asociación de Esclerosis Múltiple de Toledo (ADEMTO), Toledo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Balaguer-Bernaldo-de-Quirós', 'Affiliation': 'Robotics Lab. University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Jardón-Huete', 'Affiliation': 'Robotics Lab. University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00718-x']
2544,32660609,Pyrotinib with trastuzumab and aromatase inhibitors as first-line treatment for HER2 positive and hormone receptor positive metastatic or locally advanced breast cancer: study protocol of a randomized controlled trial.,"BACKGROUND


HER2 dual-blockade combined with aromatase inhibitors (AI) is a promising strategy to improve progression-free survival (PFS) in hormone receptor (HR) positive, metastatic breast cancer (MBC). Pyrotinib is a novel irreversible epidermal growth factor receptor/HER2 dual tyrosine kinase inhibitor. However, there is scarcity of data on the effectiveness and safety of pyrotinib combined with trastuzumab and AI as first-line treatment in a metastatic setting.
METHODS/DESIGN


The present study is a prospective, randomized, open-label trial. 198 patients with HER2+/HR+ MBC will be recruited. Eligible patients will be allocated (2:1) to either an experimental group (pyrotinib + trastuzumab + AI) or a control group (trastuzumab + AI). Allocation will be stratified by 1) time since adjuvant hormone therapy (≤ 12 months/> 12 months/no prior hormone therapy); 2) lesion sites (visceral / non-visceral). The primary endpoint is PFS.
DISCUSSION


To our knowledge, this is the first prospective randomized controlled trial to assess dual HER2-blockade with pyrotinib in the metastatic setting. This study will provide valuable evidence regarding the efficacy and safety of pyrotinib when combined with trastuzumab and an AI as first-line treatment for MBC. Moreover, it will also evaluate the feasibility of endocrine therapy as an alternative to chemotherapy in providing de-escalation therapy with less toxicity for advanced HR+/HER2+ patients.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03910712 . Registered on 10 Apr. 2019.",2020,Allocation will be stratified by 1) time since adjuvant hormone therapy (≤ 12 months/> 12 months/no prior hormone therapy); 2) lesion sites (visceral / non-visceral).,"['HER2 positive and hormone receptor positive metastatic or locally advanced breast cancer', 'advanced HR+/HER2+ patients', '198 patients with HER2+/HR+ MBC will be recruited']","['trastuzumab', 'experimental group (pyrotinib + trastuzumab + AI) or a control group (trastuzumab + AI', 'endocrine therapy', 'aromatase inhibitors (AI', 'Pyrotinib with trastuzumab and aromatase inhibitors']",['PFS'],"[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",198.0,0.108135,Allocation will be stratified by 1) time since adjuvant hormone therapy (≤ 12 months/> 12 months/no prior hormone therapy); 2) lesion sites (visceral / non-visceral).,"[{'ForeName': 'Changjun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Yidong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Mao', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Hanjiang', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Dermatology, 90 Medical Center Way, Surge 110, University of California, San Francisco, CA, 94143-0989, USA.'}, {'ForeName': 'Jinghong', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Songjie', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. sunqiangpumch@sina.com.'}]",BMC cancer,['10.1186/s12885-020-07143-2']
2545,32660611,"A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


Primary Objective • To evaluate the effect of ravulizumab, a long-acting complement (C5) inhibitor plus best supportive care (BSC) compared with BSC alone on the survival of patients with COVID-19. Secondary Objectives • Number of days free of mechanical ventilation at Day 29 • Duration of intensive care unit stay at Day 29 • Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 29 • Change from baseline in peripheral capillary oxygen saturation/ fraction of inspired oxygen (SpO2 /FiO2) at Day 29 • Duration of hospitalization at Day 29 • Survival (based on all-cause mortality) at Day 60 and Day 90 Safety • Incidence of treatment-emergent adverse events and treatment-emergent serious adverse events. PK/PD/Immunogenicity • Change in serum ravulizumab concentrations over time • Change in serum free and total C5 concentrations over time • Incidence and titer of anti-ALXN1210 antibodies Biomarkers • Change in absolute level of soluble biomarkers in blood associated with complement activation, inflammatory processes, and hypercoagulable states over time Exploratory • Incidence of progression to renal failure requiring dialysis at Day 29 • Time to clinical improvement (based on a modified 6-point ordinal scale) over 29 days • SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores at Day 29 (or discharge), Day 60, and Day 90 • EuroQol 5-dimension 5-level (EQ-5D-5L) scores at Day 29 (or discharge), Day 60, and Day 90 TRIAL DESIGN: This is a multicenter Phase 3, open-label, randomized, controlled, study. The study is being conducted in acute care hospital settings in the United States, United Kingdom, Spain, France, Germany, and Japan.
PARTICIPANTS


Male or female patients at least 18 years of age, weighing ≥ 40 kg, admitted to a designated hospital facility for treatment will be screened for eligibility in this study. Key Inclusion criteria • Confirmed diagnosis of SARS-CoV-2 infection (eg, via polymerase chain reaction [PCR] and/or antibody test) presenting as severe COVID-19 requiring hospitalization • Severe pneumonia, acute lung injury, or ARDS confirmed by computed tomography (CT) or X-ray at Screening or within the 3 days prior to Screening, as part of the patient's routine clinical care • Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or non-invasive (with continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) Key Exclusion criteria • Patient is not expected to survive for more than 24 hours • Patient is on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening • Severe pre-existing cardiac disease (ie, NYHA Class 3 or Class 4, acute coronary syndrome, or persistent ventricular tachyarrhythmias) • Patient has an unresolved Neisseria meningitidis infection Excluded medications and therapies • Current treatment with a complement inhibitor • Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization on Day 1 Excluded prior/concurrent clinical study experience • Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever is greater • Exceptions a. Investigational therapies will be allowed if received as part of best supportive care through an expanded access protocol or emergency approval for the treatment of COVID-19. b. Investigational antiviral therapies (such as remdesivir) will be allowed even if received as part of a clinical study.
INTERVENTION AND COMPARATOR


The study consists of a Screening Period of up to 3 days, a Primary Evaluation Period of 4 weeks, a final assessment at Day 29, and a Follow-up Period of 8 weeks. For patients randomized to ravulizumab plus BSC, a weight-based dose of ravulizumab (≥40 to < 60 kg/2400 mg, 60 to < 100 kg/2700 mg, ≥ 100 kg/3000 mg) will be administered on Day 1. On Day 5 and Day 10, additional doses of 600 mg (≥40 to <60 kg) or 900 mg (>60 kg) ravulizumab will be administered and on Day 15 patients will receive 900 mg ravulizumab. There is no active or placebo comparator in this open-label clinical trial. The total duration of each patient's participation is anticipated to be approximately 3 months.
MAIN OUTCOMES


The primary efficacy outcome of this study is survival (based on all-cause mortality) at Day 29.
RANDOMISATION


Patients will be randomized in a 2:1 ratio (ravulizumab plus BSC:BSC alone). Randomization will be stratified by intubated or not intubated on Day 1. Computer-generated randomization lists will be prepared by a third party under the direction of the sponsor. Investigators, or designees, will enrol patients and then obtain randomization codes using an interactive voice/web response system. The block size will be kept concealed so that investigators cannot select patients for a particular treatment assignment. Blinding (masking): This is an open-label study. Numbers to be randomised (sample size): Approximately 270 patients will be randomly assigned in a 2:1 ratio to ravulizumab plus BSC (n=180) or BSC alone (n=90).
TRIAL STATUS


Protocol Number: ALXN1210-COV-305 Original Protocol: 09 Apr 2020 Protocol Amendment 1 (Global): 13 Apr 2020 Protocol Amendment 2 (Global): 17 Apr 2020 Protocol Amendment 3 (Global): 09 Jun 2020 Recruitment is currently ongoing. Recruitment was initiated on 11 May 2020. We expect recruitment to be completed by 30 Nov 2020.
TRIAL REGISTRATION


Clinicaltrials.gov: Protocol Registry Number: NCT04369469 ; First posted; 30 Apr 2020 EU Clinical Trials Register: EudraCT Number: https://www.clinicaltrialsregister.eu/ctr-search/search?query=ALXN1210-COV-305 , Start date: 07 May 2020 FULL PROTOCOL: The full redacted protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Duration of intensive care unit stay at Day 29 • Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 29 • Change from baseline in peripheral capillary oxygen saturation/ fraction of inspired oxygen (SpO2 /FiO2) at Day 29,"['patients with COVID-19', 'Approximately 270 patients', 'Male or female patients at least 18 years of age, weighing ≥ 40 kg, admitted to a designated hospital facility for treatment will be screened for eligibility in this study', 'Protocol Number', 'Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome']","['investigational therapy', 'BSC alone', 'ravulizumab', 'Intravenous immunoglobulin (IVIg', 'Ravulizumab', 'ravulizumab, a long-acting complement (C5) inhibitor plus best supportive care (BSC', 'ravulizumab plus BSC', 'invasive (requiring endotracheal intubation) or non-invasive (with continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP', 'complement inhibitor •']","['Efficacy and Safety', 'serum ravulizumab concentrations', 'Number of days free of mechanical ventilation at Day 29 •', 'Duration of intensive care unit stay', 'Sequential Organ Failure Assessment (SOFA) score', 'free and total C5 concentrations', 'SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores at Day 29 (or discharge), Day 60, and Day 90 • EuroQol 5-dimension 5-level (EQ-5D-5L) scores', '• Duration of hospitalization at Day 29 • Survival', ""total duration of each patient's participation"", 'survival (based on all-cause mortality', 'Severe pneumonia, acute lung injury, or ARDS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0949266', 'cui_str': 'Investigational Therapies'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1564892', 'cui_str': 'Complement inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030699', 'cui_str': 'Client participation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]",15.0,0.398024,Duration of intensive care unit stay at Day 29 • Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 29 • Change from baseline in peripheral capillary oxygen saturation/ fraction of inspired oxygen (SpO2 /FiO2) at Day 29,"[{'ForeName': 'Keisha', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Medical Writing, Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Pace', 'Affiliation': 'Quantitative Sciences, Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ortiz', 'Affiliation': 'Clinical Pharmacology, Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Shamsah', 'Initials': 'S', 'LastName': 'Kazani', 'Affiliation': 'Department of Clinical Development Sciences, Alexion Pharmaceuticals, Inc., 121 Seaport Boulevard, Boston, MA, 02210, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rottinghaus', 'Affiliation': 'Department of Clinical Development Sciences, Alexion Pharmaceuticals, Inc., 121 Seaport Boulevard, Boston, MA, 02210, USA. Scott.Rottinghaus@alexion.com.'}]",Trials,['10.1186/s13063-020-04548-z']
2546,32660637,3-h drain clamping is not effective to reduce total blood loss after primary total knowledge.,"PURPOSE


Total knee arthroplasty (TKA) is a clinically efficacious surgical option for end-stage knee osteoarthritis. However, TKA increases the risk of serious bleeding and blood transfusion. The objective of this study was to evaluate the difference in postoperative blood loss in groups subjected to 3 h of clamping and non-clamping and determine the variations in rate and amount of transfusion after TKA between the two groups.
MATERIALS AND METHODS


Propensity score matching of the group subjected to 3-h drain clamping (43 patients; September 2015 to April 2016) and the control group (43 patients; before initiating the clamping method) was performed in patients undergoing unilateral primary posterior stabilized TKA. The two groups were compared. We measured the total drained blood volume until the drain was removed 48 h after surgery, and we compared the preoperative levels of hemoglobin and hematocrit with levels observed on days 1 and 2 after surgery. We also determined the blood transfusion rate and volume as well as the occurrence of clamping-associated complications.
RESULTS


In the group subjected to 3-h drain clamping, the mean volume of total drained blood was significantly lower than in the control group (333.8 ± 190.2 mL vs. 839.9 ± 339.8 mL, P <0.001). There was no significant difference in total blood loss between the two groups (1226.9 ± 488.1 mL vs. 1127.1 ± 424.5 mL, P = 0.315), but the hidden blood loss was significantly higher in the 3-h drain clamping group than in the control group (893.1 ± 487.7 mL vs. 294.7 ± 531.8 mL, P <0.001). Both the transfusion rate and amount in the 3-h drain clamped group were higher than in the control group but were not statistically significant (30.2% vs. 37.2%, P = 0.494 and 269.8 ± 483.8 mL vs. 316.3 ± 158.2 mL, P = 0.648, respectively). No significant differences in complications, including deep vein thrombosis, pulmonary thromboembolism, and oozing, were noted between the two groups (all, P = 1.000).
CONCLUSIONS


The 3-h drain clamping method after primary TKA using posterior stabilized implant reduced the loss of postoperative drained blood. However, hidden blood loss was significantly higher in the 3-h drain clamping group; as a result, there were no differences in total blood loss and transfusion rate. The clamping method did not significantly alter the complication rate.",2020,"No significant differences in complications, including deep vein thrombosis, pulmonary thromboembolism, and oozing, were noted between the two groups (all, P = 1.000).
",['43 patients; September 2015 to April 2016) and the control group (43 patients'],"['drain clamping', '3-h drain clamping', 'Total knee arthroplasty (TKA', 'unilateral primary posterior stabilized TKA', 'TKA']","['blood transfusion rate and volume', 'total blood loss', 'risk of serious bleeding and blood transfusion', 'transfusion rate', 'loss of postoperative drained blood', 'total drained blood volume until the drain', 'total blood loss and transfusion rate', 'hidden blood loss', 'complication rate', 'mean volume of total drained blood', 'postoperative blood loss', 'complications, including deep vein thrombosis, pulmonary thromboembolism, and oozing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0524702', 'cui_str': 'Pulmonary thromboembolism'}]",,0.045429,"No significant differences in complications, including deep vein thrombosis, pulmonary thromboembolism, and oozing, were noted between the two groups (all, P = 1.000).
","[{'ForeName': 'Dojoon', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': ""The Department of Orthopedic Surgery, St. Vincent's Hospital, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, South Korea.""}, {'ForeName': 'Youn Ho', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': ""The Department of Orthopedic Surgery, St. Vincent's Hospital, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, South Korea.""}, {'ForeName': 'Kwang Hyun', 'Initials': 'KH', 'LastName': 'Cho', 'Affiliation': ""The Department of Orthopedic Surgery, St. Vincent's Hospital, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, South Korea.""}, {'ForeName': 'Hae Seok', 'Initials': 'HS', 'LastName': 'Koh', 'Affiliation': ""The Department of Orthopedic Surgery, St. Vincent's Hospital, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, South Korea. vincentos@naver.com.""}]",Knee surgery & related research,['10.1186/s43019-020-00051-6']
2547,32660708,Repeteability of Circulating Eosinophil Measures and Inhaled Corticosteroids Effect in Bronchiectasis. A Post Hoc Analysis of a Randomized Clinical Trial.,,2020,,['Bronchiectasis'],[],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}]",[],[],,0.0809084,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.06.005']
2548,32660716,Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial.,"BACKGROUND


Minimally invasive thoracic surgery causes significant postoperative pain. Erector spinae plane (ESP) block and serratus anterior plane (SAP) block promise effective thoracic analgesia compared with systemically administered opioids, but have never been compared in terms of terms of quality of recovery and overall morbidity after minimally invasive thoracic surgery.
METHODS


Sixty adult patients undergoing minimally invasive thoracic surgery were randomly assigned to receive either single-shot ESP or SAP block before surgery using levobupivacaine 0.25%, 30 ml. The primary outcome was quality of patient recovery at 24 h, using the Quality of Recovery-15 (QoR-15) scale. Secondary outcomes included area under the curve (AUC) of pain verbal rating scale (VRS) over time, time to first opioid analgesia, postoperative 24 h opioid consumption, in-hospital comprehensive complication index (CCI) score and hospital stay.
RESULTS


The QoR-15 score was higher among ESP patients compared with those in the SAP group, mean (standard deviation): 114 (16) vs 102 (22) (P=0.02). Time (min) to first i.v. opioid analgesia in recovery was 32.6 (20.6) in ESP vs 12.7 (9.5) in SAP (P=0.003). AUC at rest was 92 (31) mm h -1 vs 112 (35) in ESP and SAP (P=0.03), respectively, whereas AUC on deep inspiration was 107 mm h -1  (32) vs 129 (32) in ESP and SAP (P=0.01), respectively. VRS pain on movement in ESP and SAP at 24 h was, median (25-75% range): 4 (2-4) vs 5 (3-6) (P=0.04), respectively. Opioid consumption at 24 h postoperatively was 29 (31) vs 39 (34) (P=0.37). Median (25-75%) CCI in ESP and SAP was 1 (0-2) vs 4 (0-26) (P=0.03), whereas hospital stay was 3 (2-6) vs 6 (3-9) days (P=0.17), respectively.
CONCLUSION


Compared with SAP, ESP provides superior quality of recovery at 24 h, lower morbidity, and better analgesia after minimally invasive thoracic surgery.
CLINICAL TRIAL REGISTRATION


NCT03862612.",2020,Opioid consumption at 24 h postoperatively was 29 (31) vs 39 (34) (P=0.37).,"['minimally invasive thoracic surgery', 'Sixty adult patients undergoing minimally invasive thoracic surgery']","['Erector spinae plane (ESP) block and serratus anterior plane (SAP) block', 'SAP, ESP', 'erector spinae plane block with serratus anterior plane block', 'single-shot ESP or SAP block before surgery using levobupivacaine']","['QoR-15 score', 'opioid analgesia in recovery', 'CCI in ESP and SAP', 'lower morbidity, and better analgesia', 'VRS pain on movement in ESP and SAP', 'area under the curve (AUC) of pain verbal rating scale (VRS) over time, time to first opioid analgesia, postoperative 24 h opioid consumption, in-hospital comprehensive complication index (CCI) score and hospital stay', 'postoperative pain', 'quality of recovery and overall morbidity', 'quality of patient recovery at 24 h, using the Quality of Recovery-15 (QoR-15) scale', 'hospital stay', 'Opioid consumption', 'AUC on deep inspiration']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",60.0,0.312774,Opioid consumption at 24 h postoperatively was 29 (31) vs 39 (34) (P=0.37).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Finnerty', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland; School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204 Euro-Periscope, Brussels, Belgium. Electronic address: dylantfinnerty@gmail.com.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'McMahon', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McNamara', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Hartigan', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': 'Buggy', 'Affiliation': 'Division of Anaesthesiology, Mater Misericordiae University Hospital, Dublin, Ireland; School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204 Euro-Periscope, Brussels, Belgium; Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.020']
2549,32660725,Pregnancy and neonatal outcomes 42 months after application of hyaluronic acid gel following dilation and curettage for miscarriage in women who have experienced at least one previous curettage: follow-up of a randomized controlled trial.,"OBJECTIVE


To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes.
DESIGN


Follow-up of a prospective randomized trial.
SETTING


University and university-affiliated teaching hospitals.
PATIENT(S)


Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed.
INTERVENTION(S)


Participants received a questionnaire 30 months after treatment.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy and outcome of subsequent pregnancies.
RESULT(S)


Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively.
CONCLUSION(S)


Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs.
DUTCH CLINICAL TRIAL REGISTRY NUMBER


NTR 3120.",2020,"Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive.","['University and university-affiliated teaching hospitals', ""\n\n\nWomen with a miscarriage at <14 weeks' gestation with at least one previous D&C"", 'women who have experienced at least one previous curettage', 'women with at least one previous D&C']","['hyaluronic acid (ACP) gel after dilation and curettage (D&C', 'ACP gel', 'hyaluronic acid gel', 'D&C plus ACP gel (intervention) or D&C alone (control', 'dilation and curettage']","['menstrual blood loss', 'median times to conception leading to a live birth', 'dysmenorrhea']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0968234', 'cui_str': 'auto-cross-linked polysaccharide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",,0.185464,"Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive.","[{'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynecology, Zaans Medical Center, Zaandam, the Netherlands; Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands. Electronic address: hooker.a@zaansmc.n.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hans A M', 'Initials': 'HAM', 'LastName': 'Brölmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.04.021']
2550,32660748,Concomitant Antibiotic Use and Survival in Urothelial Carcinoma Treated with Atezolizumab.,"Antibiotic effects on the gut microbiota may negatively impact survival with immune checkpoint inhibitors (ICIs). However, there is minimal evidence regarding whether antibiotic impacts are specific to ICIs or impacts in urothelial carcinoma (UC). In a post hoc analysis of IMvigor210 (single-arm atezolizumab) and IMvigor211 (phase III randomised trial of atezolizumab vs chemotherapy), the association between antibiotic use and overall survival (OS) and progression-free survival (PFS) was assessed via Cox proportional hazard analysis. Antibiotic use was defined as any antibiotic administration between 30 d prior to and 30 d after treatment initiation. Antibiotic use was associated with worse OS (n = 847, hazard ratio or HR [95% confidence interval {CI}] = 1.44 [1.19-1.73]) and PFS (1.24 [1.05-1.46]) with atezolizumab, but not chemotherapy (n = 415, 1.15 [0.91-1.46] and 1.09 [0.88-1.36], respectively). In the randomised cohort of IMvigor211, the OS treatment effect (HR [95% CI]) of atezolizumab versus chemotherapy was 0.95 (95% CI 0.71-1.25) for antibiotic users, compared with 0.73 (0.60-0.88) for nonusers (p[interaction] = 0.1). Similar associations were noted in the PD-L1 IC2/3 population. In conclusion, antibiotic use was associated with worse survival outcomes in UC patients treated with atezolizumab. The study does not justify a change in antibiotic selection for infections; however antibiotic overuse occurs in cancer care and this needs to be evaluated for ICIs. PATIENT SUMMARY: In this report from clinical trials IMvigor210 and IMvigor211, it was demonstrated that antibiotic use is consistently associated with worse survival in patients with urothelial carcinoma treated with atezolizumab. No antibiotic association was observed in patients treated with chemotherapy, suggesting that antibiotics may specifically reduce the effectiveness of cancer immunotherapies. Future research will continue to explore the effect of antibiotics on other immune checkpoint inhibitors and confirm whether immune checkpoint inhibitors remain the treatment of choice in cancer patients requiring antibiotics.",2020,"Antibiotic use was associated with worse OS (n = 847, hazard ratio or HR","['patients with urothelial carcinoma treated with', 'cancer patients requiring antibiotics']","['atezolizumab', 'atezolizumab vs chemotherapy', 'IMvigor210 (single-arm atezolizumab) and IMvigor211', 'Atezolizumab']","['PFS', 'hazard ratio or HR', 'antibiotic use and overall survival (OS) and progression-free survival (PFS', 'effectiveness of cancer immunotherapies', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0278348', 'cui_str': 'Immunotherapy for cancer'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.398125,"Antibiotic use was associated with worse OS (n = 847, hazard ratio or HR","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia. Electronic address: ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia; Department of Medical Oncology, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia; Department of Medical Oncology, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",European urology,['10.1016/j.eururo.2020.06.061']
2551,32660762,Differences in intermediate vision: monofocal intraocular lenses vs. monofocal extended depth of focus intraocular lenses.,"PURPOSE


The purpose of this study was to analyse whether an extended depth of focus (EDOF) monofocal intraocular lens (IOL) (TECNIS Eyhance™, Johnson&Johnson Surgical Vision, Inc., Santa Ana, CA) provides better intermediate visual acuity (VA) than another monofocal IOL (TECNIS 1-piece™, Johnson&Johnson Surgical Vision, Inc., Santa Ana, CA) from the same platform.
METHODS


Randomised prospective observational study. Patients who required cataract surgery in both eyes were included. Patients in one group were implanted with Tecnis 1-piece IOL and those in the other group with Eyhance EDOF monofocal IOL. One month after surgery in the second eye, we assessed the corrected intermediate VA (66 cm) and obtained defocus curves. We also explored the correlation of: high-order and spherical aberrations with intermediate VA, pupil size with intermediate VA and age with intermediate VA.
RESULTS


We analysed 30 patients (60 eyes), 15 patients in the TECNIS 1-piece group and 15 in the Eyhance group. Both groups achieved a far VA of 0.00 logMAR. In contrast, for intermediate vision, VA was better with the Eyhance EDOF monofocal IOLs (0.16 ± 0.12 LogMAR), the difference being statistically significant (p < 0.001). In addition, binocular intermediate VA was found to be significantly correlated with corneal (6 mm) RMS high-order aberrations (ρ 0.476) and Z 4 0  (ρ 0.483) with the Eyhance IOL.
CONCLUSIONS


The new EDOF monofocal IOL (Eyhance) offers sufficient depth of focus to provide patients with comfortable vision without impairing far vision.",2020,"In addition, binocular intermediate VA was found to be significantly correlated with corneal (6 mm) RMS high-order aberrations (ρ 0.476) and Z 4 0  (ρ 0.483) with the Eyhance IOL.
","['patients with comfortable vision without impairing far vision', '30 patients (60 eyes), 15 patients in the TECNIS 1-piece group and 15 in the Eyhance group', 'Patients who required cataract surgery in both eyes were included']","['extended depth of focus (EDOF) monofocal intraocular lens (IOL) (TECNIS Eyhance™, Johnson&Johnson Surgical Vision, Inc., Santa Ana, CA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0003243', 'cui_str': 'Antinuclear antibody'}]",[],30.0,0.0222864,"In addition, binocular intermediate VA was found to be significantly correlated with corneal (6 mm) RMS high-order aberrations (ρ 0.476) and Z 4 0  (ρ 0.483) with the Eyhance IOL.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'de Luis Eguileor', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España. Electronic address: beatrizdeluis@gmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Martínez-Indart', 'Affiliation': 'Biocruces Bizkaia Health Research Institute, Barakaldo, España.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martínez Alday', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sacristán Egüén', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cuadros Sánchez', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España.'}]",Archivos de la Sociedad Espanola de Oftalmologia,['10.1016/j.oftal.2020.06.009']
2552,32660769,"Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta® in Healthy Subjects: a Randomized, Double-blind Trial.","PURPOSE


MSB11455 is a proposed biosimilar to the reference pegfilgrastim (Neulasta®). This pivotal equivalence study (NCT03251248) assessed the pharmacokinetic and pharmacodynamic equivalence of MSB11455 to the reference product.
METHODS


This 2-way, 2-sequence, group-sequential, crossover study was conducted in healthy subjects. Subjects received a single subcutaneous dose of MSB11455 or the reference product (both 6 mg/0.6 mL) on Day 1 of each study period. Pharmacokinetic and pharmacodynamic (absolute neutrophil count; ANC) samples were taken predose and up to day 16 post-dose. Non-compartmental parameters were calculated. Immunogenicity samples were taken pre-dose and up to day 84 after the first dose. Safety was assessed throughout the study.
FINDINGS


A total of 292 subjects were randomized to therapy and treated; 244 received both treatments. For all primary pharmacokinetic and pharmacodynamic parameters, 90% repeated confidence intervals of geometric means ratio of MSB11455 to the reference product were within the pre-defined equivalence range (80.00%-125.00%) for AUC 0-∞  (96.59-112.82); AUC 0-last  (97.29-113.96), C max  (97.13-114.99), maximum observed effect on ANC (98.74-102.39), and area under the effect-time curve from time zero to time to last quantifiable concentration (97.30-100.23). Safety, tolerability, and immunogenicity were comparable between treatments. No filgrastim-specific neutralizing antibodies were detected with either treatment sequence.
IMPLICATIONS


Pharmacokinetic and pharmacodynamic equivalence of MSB11455 and the reference product was shown, with comparable immunogenicity, safety, and tolerability between treatments. The study supports the biosimilarity of MSB11455 to the reference product. ClinicalTrials.gov identifier: NCT03251248.",2020,"Safety, tolerability, and immunogenicity were comparable between treatments.","['292 subjects', 'healthy subjects', 'Healthy Subjects']","['MSB11455', 'Pegfilgrastim Biosimilar MSB11455']","['Safety', 'Safety, tolerability, and immunogenicity', 'immunogenicity, safety, and tolerability', 'Immunogenicity samples', 'Pharmacokinetic and pharmacodynamic (absolute neutrophil count; ANC) samples']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",292.0,0.056325,"Safety, tolerability, and immunogenicity were comparable between treatments.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'Radmila', 'Initials': 'R', 'LastName': 'Kanceva', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland. Electronic address: Radmila.Kanceva@fresenius-kabi.com.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Vincent', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schueler', 'Affiliation': 'Biostatistics, Merck Healthcare, Darmstadt, Germany.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Harrison-Moench', 'Affiliation': 'Quantitative Pharmacology, Merck Healthcare, Darmstadt, Germany.'}, {'ForeName': 'Corinne Seng', 'Initials': 'CS', 'LastName': 'Yue', 'Affiliation': 'Learn and Confirm, Inc., St-Laurent, Québec, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ullmann', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Ghori', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffin', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, Australia.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.020']
2553,32660869,"A Double-Blind, Randomized, Placebo-Controlled Clinical Study of Trofinetide in the Treatment of Fragile X Syndrome.","BACKGROUND


We analyze the safety and tolerability of trofinetide and provide a preliminary evaluation of its efficacy in adolescent and adult males with fragile X syndrome.
METHODS


This study was an exploratory, phase 2, multicenter, double-blind, placebo-controlled, parallel group study of the safety and tolerability of orally administered trofinetide in 72 adolescent and adult males with fragile X syndrome. Subjects were randomly assigned in a 1:1:1 ratio to 35 or 70 mg/kg twice daily trofinetide or placebo for 28 days. Safety assessments included adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and concomitant medications. Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
RESULTS


Both 35 and 70 mg/kg dose levels of trofinetide were well tolerated and appeared to be generally safe. Trofinetide at the 70 mg/kg dose level demonstrated efficacy compared with placebo based on prespecified criteria. On the basis of a permutation test, the probability of a false-positive outcome for the achieved prespecified success was 0.045. In the group analysis, improvement from treatment baseline was demonstrated on three fragile X syndrome-specific outcome measures.
CONCLUSIONS


Trofinetide was well tolerated in adolescent and adult males with fragile X syndrome. Despite the relatively short duration of the study, a consistent signal of efficacy at the higher dose was observed in both caregiver and clinician assessments, based on a novel analytical model incorporating evaluation of multiple key symptom areas of fragile X syndrome. This finding suggests a potential for trofinetide treatment to provide clinically meaningful improvement in core fragile X syndrome symptoms.",2020,"Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
","['72 adolescent and adult males with fragile X syndrome', 'Fragile X Syndrome', 'adolescent and adult males with fragile X syndrome']","['trofinetide or placebo', 'trofinetide', 'Placebo', 'placebo']","['safety and tolerability', 'adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and concomitant medications']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016667', 'cui_str': 'Fragile X syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",72.0,0.270683,"Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Berry-Kravis', 'Affiliation': 'Department of Pediatrics, Rush University Medical Center, Chicago, Illinois; Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois; Department of Biochemistry, Rush University Medical Center, Chicago, Illinois. Electronic address: Elizabeth_Berry-Kravis@rush.edu.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Horrigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tartaglia', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Hagerman', 'Affiliation': 'Department of Pediatrics, University of California Davis MIND Institute, Sacramento, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Child and Adolescent Psychiatry, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Hatti', 'Affiliation': 'Suburban Research Associates, Media, Pennsylvania.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'AMO Pharma Ltd., London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yaroshinsky', 'Affiliation': 'Vital Systems, Inc., Rolling Meadows, Illinois.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Stoms', 'Affiliation': 'Vital Systems, Inc., Rolling Meadows, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Glass', 'Affiliation': 'Neuren Pharmaceuticals, Ltd., Melbourne, Victoria, Australia.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Jones', 'Affiliation': 'Neuren Pharmaceuticals, Ltd., Melbourne, Victoria, Australia.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.04.019']
2554,32660872,Is the addition of vaginal electrical stimulation to transcutaneous tibial nerve electrical stimulation more effective for overactive bladder treatment? A randomized controlled trial.,"INTRODUCTION AND OBJECTIVES


Overactive bladder (OAB) is a prevalent disorder that increases with age and impairs patients' quality of life. Guidelines recommend behavior modifications as the first-line treatment; however, physiotherapy has also been used with success, safety, and low cost. Transcutaneous tibial nerve electrical stimulation (TTNS) and vaginal electrical stimulation (VS) are being used in clinical physiotherapy practice. This study aimed to verify whether the addition of VS to TTNS is more beneficial than TTNS alone for women with OAB.
PATIENTS AND METHODS


In all, 106 women aged >18 years diagnosed with OAB or mixed urinary incontinence with prevalent OAB symptoms were randomly divided into 2 groups: Group 1: TTNS (n = 52); Group 2: TTNS + VS (n = 54). The 3 day voiding diary, pelvic floor muscle strength (Ortiz Scale), King's Health Questionnaire, and Overactive Bladder Questionnaire were assessed before and after treatment. Urinary frequency was considered the primary outcome, and a reduction of ≥ 3 micturitions/day was considered clinically relevant. Mixed linear models were used to compare the 2groups.
RESULTS


Initially, the groups were similar in age, body mass index, number of pregnancies, time of OAB onset, and prevalence of OAB symptoms. After treatment, a reduction in urinary frequency of 1.5 micturitions was observed in Group 2, which was not clinically relevant despite being statistically significant.
CONCLUSIONS


The addition of VS to TTNS for the treatment of OAB was not more effective than TTNS as a single therapy.",2020,"After treatment, a reduction in urinary frequency of 1.5 micturitions was observed in Group 2, which was not clinically relevant despite being statistically significant.
","['106 women aged >18 years diagnosed with OAB or mixed urinary incontinence with prevalent OAB symptoms', 'women with OAB']","['TTNS + VS', 'TTNS', 'Transcutaneous tibial nerve electrical stimulation (TTNS) and vaginal electrical stimulation (VS', 'transcutaneous tibial nerve electrical stimulation']","['urinary frequency of 1.5 micturitions', 'Urinary frequency', ""voiding diary, pelvic floor muscle strength (Ortiz Scale), King's Health Questionnaire, and Overactive Bladder Questionnaire""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]",106.0,0.0986953,"After treatment, a reduction in urinary frequency of 1.5 micturitions was observed in Group 2, which was not clinically relevant despite being statistically significant.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bacchi Ambrosano Giarreta', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiología y Terapia Ocupacional, Facultad de Medicina, Universidad de São Paulo, São Paulo, Brasil. Electronic address: fe.fisio@terra.com.br.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Milhem Haddad', 'Affiliation': 'Departamento de Obstetricia y Ginecología, Facultad de Medicina, Universidad de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Souza de Carvalho Fusco', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiología y Terapia Ocupacional, Facultad de Medicina, Universidad de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chada Baracat', 'Affiliation': 'Departamento de Obstetricia y Ginecología, Facultad de Medicina, Universidad de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Casarotto', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiología y Terapia Ocupacional, Facultad de Medicina, Universidad de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alves Gonçalves Ferreira', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiología y Terapia Ocupacional, Facultad de Medicina, Universidad de São Paulo, São Paulo, Brasil.'}]",Actas urologicas espanolas,['10.1016/j.acuro.2020.03.012']
2555,32660919,Directed vertebral manipulation is not better than generic vertebral manipulation in patients with chronic low back pain: a randomised trial.,"QUESTION


In people with chronic low back pain, what is the average effect of directing manipulation at the most painful lumbar level compared with generic manipulation of the spine?
DESIGN


Randomised controlled trial with concealed allocation, a blinded assessor and intention-to-treat analysis.
PARTICIPANTS


148 people with non-specific chronic low back pain with a minimum level of pain intensity of 3 points (measured from 0 to 10 on the Pain Numerical Rating Scale).
INTERVENTIONS


All participants received 10 spinal manipulation sessions over a 4-week period. The experimental group received treatment to the most painful segment of the lower back. The control group received treatment to the thoracic spine.
OUTCOME MEASURES


The primary outcome was pain intensity, measured at the end of the intervention (Week 4). Secondary outcomes were: pain intensity at Weeks 12 and 26; pressure pain threshold at Week 4; and global perceived change since onset and disability, both measured at Weeks 4, 12 and 26.
RESULTS


Each group was randomly allocated 74 participants. Data were collected at all time points for 71 participants (96%) in the experimental group and 72 (97%) in the control group. There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point. The estimate of the effect of directing manipulation at the most painful lumbar level, as compared with generic manipulation, on pain intensity was too small to be considered clinically important: MD 0 (95% CI -0.9 to 0.9) at Week 4 and -0.1 (95% CI -1.0 to 0.8) at Week 26.
CONCLUSION


No clinically important differences were observed between directed manipulation and generic manipulation in people with chronic low back pain.
TRIAL REGISTRATION


NCT02883634.",2020,"There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point.","['148 people with non-specific chronic low back pain with a minimum level of pain intensity of 3 points (measured from 0 to 10 on the Pain Numerical Rating Scale', 'people with chronic low back pain', 'patients with chronic low back pain']","['10 spinal manipulation sessions', 'Directed vertebral manipulation', 'generic vertebral manipulation']","['pain intensity', 'pain intensity at Weeks 12 and 26; pressure pain threshold at Week 4; and global perceived change since onset and disability', 'pain intensity, disability or global perceived effect']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",148.0,0.284812,"There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point.","[{'ForeName': 'Ronaldo Fernando', 'Initials': 'RF', 'LastName': 'de Oliveira', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leonardo Oliveira Pena', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil. Electronic address: lcos3060@gmail.com.'}, {'ForeName': 'Leonardo Penteado', 'Initials': 'LP', 'LastName': 'Nascimento', 'Affiliation': 'Escola de Osteopatia de Madrid Internacional, São Paulo, Brazil.'}, {'ForeName': 'Lívia Leticia', 'Initials': 'LL', 'LastName': 'Rissato', 'Affiliation': 'Physical Therapy Department, UBS Santo Antônio do Aracanguá, Santo Antônio do Aracanguá, Brazil.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.06.007']
2556,32660953,Novel education-based intervention to reduce inappropriate antibiotic prescribing for treatment of gonorrhoea in China: protocol for a cluster randomised controlled trial.,"INTRODUCTION


Inappropriate use of antibiotics to treat gonorrhoea can lead to antibiotic resistance. Education programmes may be helpful for improving physician prescribing behaviours in accordance with treatment guidelines. As traditional education based on printed materials may have limited effect on guideline-based treatment, innovative education strategies are needed. The current trial aims to assess the effectiveness of a novel education intervention to increase guideline-based treatment of gonorrhoea in China.
METHODS AND ANALYSIS


We will conduct a two-arm cluster randomised control trial at 144 hospitals (clusters) in eight Chinese provinces. The intervention will include an online training video developed on the WenJuanXing platform that covers workflows and requirements for managing a patient with uncomplicated gonorrhoea. Outpatient physicians in dermatology (dermatovenerology), urology, andrology and gynaecology will be given access to the video via a quick response code. In hospitals allocated to the control arm, physicians will continue to participate in their standard of care training programme. The primary outcome is the proportion of gonorrhoea antibiotic prescriptions adherent to Chinese national guidelines at the cluster level. In addition, to understand the reasons of physician's non-adherence to the intervention by conducting a questionnaire survey will be considered as the secondary outcome of the study.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Medical Ethics Committee of the Chinese Academy of Medical Sciences Institute of Dermatology (2020-LS-004). All physicians will provide an informed consent prior to participating in the study. Findings of the trial will be disseminated through conferences and peer-reviewed journals, and will be used to develop training programmes for physicians.
TRIAL REGISTRATION NUMBER


ChiCTR2000029591.",2020,"The current trial aims to assess the effectiveness of a novel education intervention to increase guideline-based treatment of gonorrhoea in China.
","['144 hospitals (clusters) in eight Chinese provinces', 'Outpatient physicians in dermatology (dermatovenerology), urology, andrology and gynaecology', 'gonorrhoea in China']","['novel education intervention', 'Novel education-based intervention']",['proportion of gonorrhoea antibiotic prescriptions adherent to Chinese national guidelines at the cluster level'],"[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",144.0,0.107048,"The current trial aims to assess the effectiveness of a novel education intervention to increase guideline-based treatment of gonorrhoea in China.
","[{'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Jiang', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Yun-Qing', 'Initials': 'YQ', 'LastName': 'Yang', 'Affiliation': 'Department of prevention and health care, Guangzhou Institute of Dermatology, Guangzhou, China.'}, {'ForeName': 'Ning-Xiao', 'Initials': 'NX', 'LastName': 'Cao', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Yin', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Xiang-Sheng', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China chenxs@ncstdlc.org.'}]",BMJ open,['10.1136/bmjopen-2020-037549']
2557,32661106,Hyperglycemia But Not Hyperinsulinemia Is Favorable for Exercise in Type 1 Diabetes: A Pilot Study.,"OBJECTIVE


To distinguish the effects of hyperglycemia and hyperinsulinemia on exercise-induced increases in R d  and endogenous glucose production (EGP) in type 1 diabetes.
RESEARCH DESIGN AND METHODS


We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI). Glucose fluxes were measured using [6,6- 2 H 2 ] glucose before, during, and after 60 min of exercise.
RESULTS


R d  increased ( P  < 0.01) with exercise within groups while peak R d  during exercise was lower ( P  < 0.01) in participants with type 1 diabetes than participants without diabetes during all visits. In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI. This demonstrates that hyperinsulinemia, but not hyperglycemia, blunts the compensatory exercise-induced increase in EGP in type 1 diabetes.
CONCLUSIONS


The data from this pilot study indicate that  1 ) Exercise-induced compensatory increase in EGP was inhibited in participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia;  2 ) In contrast, in participants without diabetes, exercise-induced increase in EGP was inhibited only during combined hyperinsulinemia and hyperglycemia. Taken together, these results suggest that low insulin coupled with euglycemia or modest hyperglycemia appear to be the most favorable milieu for type 1 diabetes during exercise.",2020,"In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","['type 1 diabetes', 'participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia;  2 ', 'We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI']",[],"['R d  and endogenous glucose production (EGP', 'compensatory increase in EGP', 'Hyperglycemia', 'Glucose fluxes', 'EGP']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205452', 'cui_str': '6'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}]",[],"[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",6.0,0.031498,"In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Romeres', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Olson', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rickey', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cobelli', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dalla Man', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}]",Diabetes care,['10.2337/dc20-0611']
2558,32661107,"Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA).","OBJECTIVE


Sulfonylureas are first-line treatment of hepatocyte nuclear factor 1-α (HNF1A) diabetes (maturity-onset diabetes of the young type 3), but many patients do not achieve optimal glycemic control without episodes of hypoglycemia. We investigated the combination of the sulfonylurea glimepiride and the dipeptidyl peptidase-4 inhibitor linagliptin versus glimepiride monotherapy with respect to glycemic variability, glycemic control, and risk of hypoglycemia.
RESEARCH DESIGN AND METHODS


In a randomized, double-blinded, crossover trial, patients with HNF1A diabetes ( n  = 19; mean ± SD age 43 ± 14 years, BMI 24.8 ± 2.8 kg/m 2 , and glycated hemoglobin [HbA 1c ] 7.4 ± 0.2% [57.1 ± 7.3 mmol/mol]) were randomly assigned to treatment with glimepiride + linagliptin 5 mg (16 weeks), washout (4 weeks), and glimepiride + placebo (16 weeks) (or vice versa). Glimepiride was titrated targeting a fasting plasma glucose of 4.5-6.0 mmol/L without hypoglycemia. Treatments were evaluated by continuous glucose monitoring (CGM), HbA 1c , and meal test.
RESULTS


Compared with glimepiride + placebo, glimepiride + linagliptin did not significantly improve the primary end point mean amplitude of glycemic excursions (MAGE) (mean difference -0.7 mmol/L,  P =  0.1540) but displayed significant reductions in coefficient of variation on CGM (-3.6%,  P =  0.0401), HbA 1c  (-0.5%,  P =  0.0048), and glimepiride dose (-0.7 mg/day,  P =  0.0099). β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin. Incidences of hypoglycemia were similar with both treatments.
CONCLUSIONS


Linagliptin as add-on treatment to glimepiride improved glycemic variability and control without increasing risk of hypoglycemia in patients with HNF1A diabetes.",2020,β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin.,"['patients with HNF1A diabetes ( n  = 19; mean ± SD age 43 ± 14 years, BMI 24.8 ± 2.8 kg/m 2 , and glycated hemoglobin', 'Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3', 'patients with HNF1A diabetes']","['Linagliptin', 'Placebo', 'sulfonylurea glimepiride and the dipeptidyl peptidase-4 inhibitor linagliptin versus glimepiride monotherapy', 'glimepiride + placebo, glimepiride + linagliptin', 'glimepiride', 'glimepiride + placebo', 'Glimepiride', 'glimepiride + linagliptin']","['Efficacy and Safety', 'continuous glucose monitoring (CGM), HbA 1c , and meal test', 'glycemic variability', 'Incidences of hypoglycemia', 'glycemic variability, glycemic control, and risk of hypoglycemia', 'β-cell glucose sensitivity', 'coefficient of variation on CGM', 'mean amplitude of glycemic excursions (MAGE', 'risk of hypoglycemia', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1451774', 'cui_str': 'HNF1A protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",,0.166354,β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin.,"[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Støy', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Kampmann', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Seghieri', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark t.vilsboll@dadlnet.dk.'}]",Diabetes care,['10.2337/dc20-0408']
2559,32661108,Effect of Afrezza on Glucose Dynamics During HCL Treatment.,"OBJECTIVE


A major obstacle in optimizing the performance of closed loop automated insulin delivery systems has been the delay in insulin absorption and action that results from the subcutaneous (SC) route of insulin delivery leading to exaggerated postmeal hyperglycemic excursions. We aimed to investigate the effect of Afrezza inhaled insulin with ultrafast-in and -out action profile on improving postprandial blood glucose control during hybrid closed-loop (HCL) treatment in young adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS


We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (A L ) and a high (A H ) dose as compared with a standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H  and down for A L ). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to 4 h after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics.
RESULTS


The mean ± SD PPG for the rapid-acting insulin control arm and A H  was similar (185 ± 50 mg/dL vs. 195 ± 46 mg/dL, respectively;  P  = 0.45), while it was higher for meals using A L  (208 ± 54 mg/dL,  P  = 0.04). The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
CONCLUSIONS


Afrezza (A H ) premeal bolus reduced the early glycemic excursion and improved PPG during HCL compared with aspart premeal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120 min.",2020,"The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
",['young adults with type 1 diabetes'],"['Afrezza', 'hybrid closed-loop (HCL', 'Afrezza inhaled insulin with ultrafast-in and -out action profile', 'standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment', 'premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H  and down for A L ']","['early PPG level', 'PPG', 'postprandial blood glucose control', 'mean ± SD PPG', 'efficacy and safety', 'early glycemic excursion and improved PPG', 'hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics', 'peak postprandial plasma glucose (PPG) level']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3834216', 'cui_str': 'Afrezza'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.101007,"The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Galderisi', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT alfonso.galderisi@yale.edu alfonso.galderisi@unipd.it.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kraemer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}]",Diabetes care,['10.2337/dc20-0091']
2560,32661117,Correction:  Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma .,,2020,,['patients with advanced melanoma '],['ipilimumab'],['Overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.258107,,[],Journal for immunotherapy of cancer,['10.1136/jitc-2019-000391corr1']
2561,32661118,Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial.,"BACKGROUND


The extent to which response and survival benefits with immunotherapy-based regimens persist informs optimal first-line treatment options. We provide long-term follow-up in patients with advanced renal cell carcinoma (aRCC) receiving first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN) in the phase 3 CheckMate 214 trial. Survival, response, and safety outcomes with NIVO+IPI versus SUN were assessed after a minimum of 42 months of follow-up.
METHODS


Patients with aRCC were enrolled from October 16, 2014, through February 23, 2016. Patients stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and region were randomized to nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for four doses, followed by nivolumab (3 mg/kg) every 2 weeks; or SUN (50 mg) once per day for 4 weeks (6-week cycle). Primary endpoints: overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) per independent radiology review committee in IMDC intermediate-risk/poor-risk patients. Secondary endpoints: OS, PFS, and ORR in the intention-to-treat (ITT) population and safety. Favorable-risk patient outcomes were exploratory.
RESULTS


Among ITT patients, 550 were randomized to NIVO+IPI (425 intermediate/poor risk; 125 favorable risk) and 546 to SUN (422 intermediate/poor risk; 124 favorable risk). Among intermediate-risk/poor-risk patients, OS (HR, 0.66; 95% CI, 0.55-0.80) and PFS (HR, 0.75; 95% CI, 0.62-0.90) benefits were observed, and ORR was higher (42.1% vs 26.3%) with NIVO+IPI versus SUN. In ITT patients, both OS benefits (HR, 0.72; 95% CI, 0.61-0.86) and higher ORR (39.1% vs 32.6%) were observed with NIVO+IPI versus SUN. In favorable-risk patients, HR for death was 1.19 (95% CI, 0.77-1.85) and ORR was 28.8% with NIVO+IPI versus 54.0% with SUN. Duration of response was longer (HR, 0.46-0.54), and more patients achieved complete response (10.1%-12.8% vs 1.4%-5.6%) with NIVO+IPI versus SUN regardless of risk group. The incidence of treatment-related adverse events was consistent with previous reports.
CONCLUSIONS


NIVO+IPI led to improved efficacy outcomes versus SUN in both intermediate-risk/poor-risk and ITT patients that were maintained through 42 months' minimum follow-up. A complete response rate >10% was achieved with NIVO+IPI regardless of risk category, with no new safety signals detected in either arm. These results support NIVO+IPI as a first-line treatment option with the potential for durable response.
TRIAL REGISTRATION NUMBER


NCT02231749.",2020,"In ITT patients, both OS benefits (HR, 0.72; 95% CI, 0.61-0.86) and higher ORR (39.1% vs 32.6%) were observed with NIVO+IPI versus SUN.","['patients with advanced renal cell carcinoma', 'patients with advanced renal cell carcinoma (aRCC) receiving first', 'Patients stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and region', 'Patients with aRCC were enrolled from October 16, 2014, through February 23, 2016', 'ITT patients, 550 were randomized to NIVO+IPI (425 intermediate/poor risk; 125 favorable risk) and 546 to SUN (422 intermediate/poor risk; 124 favorable risk']","['nivolumab', 'nivolumab plus ipilimumab versus sunitinib', 'SUN', 'ipilimumab', 'line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN']","['higher ORR', 'Duration of response', 'OS, PFS, and ORR in the intention-to-treat (ITT) population and safety', 'Survival, response, and safety outcomes with NIVO+IPI versus SUN', 'ORR', 'Survival outcomes', 'overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) per independent radiology review committee in IMDC intermediate-risk/poor-risk patients', 'HR for death', 'complete response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.143864,"In ITT patients, both OS benefits (HR, 0.72; 95% CI, 0.61-0.86) and higher ORR (39.1% vs 32.6%) were observed with NIVO+IPI versus SUN.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA motzerr@mskcc.org.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Arén Frontera', 'Affiliation': 'Centro de Investigación Clínica Bradford Hill, Santiago, Chile.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Department of Medical Oncology, Hôpitaux Universitaires de Strasbourg / ICANS, Strasbourg, France.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Division of Hematology and Oncology, UT Southwestern Kidney Cancer Program, Dallas, Texas, USA.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Divisions of Medical Oncology and Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology, West German Cancer Center Essen, Essen, Germany.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Neiman', 'Affiliation': 'Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, The Lank Center for Genitourinary Oncology, Boston, Massachusetts, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Salman', 'Affiliation': 'Instituto Oncológico Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raya', 'Initials': 'R', 'LastName': 'Leibowitz-Amit', 'Affiliation': ""Oncology Institute, Shamir Medical Center, Be'er Yaakov, Israel.""}, {'ForeName': 'Poul F', 'Initials': 'PF', 'LastName': 'Geertsen', 'Affiliation': 'Department of Oncology, Herlev Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Department of Medical Oncology, Levine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Departments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Shruti Shally', 'Initials': 'SS', 'LastName': 'Saggi', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, University of Texas, Houston, Texas, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000891']
2562,32666050,"Phase I study of vinblastine in combination with nilotinib in children, adolescents, and young adults with refractory or recurrent low-grade glioma.","Background


New rescue regimens are needed for pediatric refractory/recurrent low-grade glioma. Nilotinib is a tyrosine kinase inhibitor that has potential synergistic effects with vinblastine on angiogenesis, tumor cell growth, and immunomodulation.
Methods


This phase I trial aimed to determine the recommended doses of this combination for phase II trials (RP2D) using the dual-agent Bayesian continual reassessment method. Nilotinib was given orally twice daily (BID) in combination with once-weekly vinblastine injections for a maximum of 12 cycles of 28 days (clinicaltrials.gov, NCT01884922).
Results


Thirty-five pediatric patients were enrolled across 4 dose levels. The median age was 7 years and 10 had neurofibromatosis type 1. Patients had received a median of 3 prior treatment lines and 25% had received more than 4 previous treatment lines. Dose-limiting toxicity (DLT) during cycle 1 was hematologic, dermatologic, and cardiovascular. The RP2D was identified at 3 mg/m 2  weekly for vinblastine with 230 mg/m 2  BID for nilotinib (estimated probability of DLT = 18%; 95% credibility interval, 7-29%). Fifteen patients completed the 12 cycles; 2 stopped therapy prematurely due to toxicity and 18 due to disease progression. Three patients achieved a partial response leading to an objective response rate of 8.8% (95% confidence interval [CI], 1.9-23.7), and the disease control rate was 85.3% (95% CI, 68.9-95.1). The 12-month progression-free survival was 37.1% (95% CI, 23.2-53.67).
Conclusions


Vinblastine and nilotinib combination was mostly limited by myelosuppression and dermatologic toxicity. The efficacy of the combination at the RP2D is currently evaluated in a randomized phase II trial comparing this regimen to vinblastine alone.",2020,"The 12-month progression-free survival was 37.1% (95% CI, 23.2-53.67).
","['children, adolescents, and young adults with refractory or recurrent low-grade glioma', 'Thirty-five pediatric patients were enrolled across 4 dose levels', 'Fifteen patients completed the 12 cycles; 2 stopped therapy prematurely due to toxicity and 18 due to disease progression', 'The median age was 7 years and 10 had neurofibromatosis type 1']","['Vinblastine and nilotinib combination', 'vinblastine', 'vinblastine injections']","['objective response rate', 'disease control rate', '12-month progression-free survival', 'myelosuppression and dermatologic toxicity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}]","[{'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",35.0,0.337307,"The 12-month progression-free survival was 37.1% (95% CI, 23.2-53.67).
","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Vairy', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Le Teuff', 'Affiliation': 'Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Bautista', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'De Carli', 'Affiliation': ""Département d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Anne-Isabelle', 'Initials': 'AI', 'LastName': 'Bertozzi', 'Affiliation': ""Département d'Hematologie et d'Oncologie Pediatrique, Hopital Purpan, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pagnier', 'Affiliation': ""Département d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Grenoble, La Tronche, France.""}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Fouyssac', 'Affiliation': ""Département d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Nancy, Nancy, France.""}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Nysom', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Aerts', 'Affiliation': 'SIREDO Center, Institut Curie, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Leblond', 'Affiliation': ""Unité d'oncologie pédiatrique, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Millot', 'Affiliation': ""Département d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Berger', 'Affiliation': ""Département d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Priest-en-Jarez, France.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Canale', 'Affiliation': 'Department of Radiology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Paci', 'Affiliation': 'Department of Pharmacology and Pharmacokinetics Unit School of Pharmacy, Université Paris-Saclay, Université Paris-Sud, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Poinsignon', 'Affiliation': 'Department of Pharmacology and Pharmacokinetics Unit School of Pharmacy, Université Paris-Saclay, Université Paris-Sud, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Chevance', 'Affiliation': 'Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Ezzalfani', 'Affiliation': 'Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Vidaud', 'Affiliation': 'Service de Génétique et Biologie Moléculaires, Hopital Cochin, Hopitaux Universitaires de Paris Centre, Assistance Publique-Hôpitaux de Paris, and EA7331, Faculte de Pharmacie de Paris, Universite Paris Descartes, Paris, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Di Giannatale', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Hladun-Alvaro', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Francois M', 'Initials': 'FM', 'LastName': 'Petit', 'Affiliation': 'Département de Génétique Moléculaire, Hopital Antoine Beclere, Clamart, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Geoerger', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Grill', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}]",Neuro-oncology advances,['10.1093/noajnl/vdaa075']
2563,32666060,Clinical Performance of Posterior Microhybrid Resin Composite Restorations Applied Using Regular and High-Power Mode Polymerization Protocols According to USPHS and SQUACE Criteria: 10-Year Randomized Controlled Split-Mouth Trial.,"PURPOSE


This randomized, split-mouth clinical study evaluated the marginal quality of direct class-I and class-II restorations made of microhybrid composite that were applied using two polymerization protocols and two marginal evaluation criteria.
MATERIALS AND METHODS


A total of 50 patients (mean age: 33 years) received 100 direct class-I or class-II restorations in premolars or molars. Three calibrated operators made the restorations. After conditioning the tooth with 2-step etch-and-rinse adhesive, restorations were made incrementally using microhybrid composite. Each layer was polymerized using a polymerization device operated either in regular mode (600-650 mW/cm2 for 20 s) (RM) or high-power (1200-1300 mW/cm2 for 10 s) mode (HPM). Two independent, calibrated operators evaluated the restorations 1 week (baseline) and 6 months after restoration placement, and thereafter annually up to 10 years using modified USPHS and SQUACE criteria. Data were analyzed using the Mann-Whitney U-test (α = 0.05).
RESULTS


Alpha scores (USPHS) for marginal adaptation (76% and 74% for RM and HPM, respectively) and marginal discoloration (70% and 72%, for RM and HPM, respectively) did not show significant differences between the two polymerization protocols (p > 0.05). Alpha scores (SQUACE) for marginal adaptation (78% and 74% for RM and HPM, respectively) and marginal discoloration (70% for both RM and HPM) were also not significantly different at the 10-year year follow-up (p > 0.05).
CONCLUSION


Regular and high-power polymerization protocols had no influence on the stability of marginal quality of the microhybrid composite tested up to 10 years. Both modified USPHS and SQUACE criteria confirmed that regardless of the polymerization mode, marginal quality of the restorations deteriorated significantly compared to baseline (p < 0.05).",2020,"Both modified USPHS and SQUACE criteria confirmed that regardless of the polymerization mode, marginal quality of the restorations deteriorated significantly compared to baseline (p < 0.05).",['50 patients (mean age: 33 years'],['100 direct class-I or class-II restorations in premolars or molars'],"['stability of marginal quality', 'Alpha scores (SQUACE) for marginal adaptation', 'Alpha scores (USPHS) for marginal adaptation', 'marginal discoloration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}]",50.0,0.0306194,"Both modified USPHS and SQUACE criteria confirmed that regardless of the polymerization mode, marginal quality of the restorations deteriorated significantly compared to baseline (p < 0.05).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerutti', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Barabanti', 'Affiliation': ''}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44865']
2564,32666061,Influence of Alternative Restoration Technique with Different Composite Resins for Flared Root Reinforcement.,"PURPOSE


To evaluate the influence of type and viscosity of composite resins used for root reinforcement in the adhesion of glass-fiber posts to flared root canals.
MATERIALS AND METHODS


The crowns of 78 uniradicular permanent teeth were removed and the teeth were endodontically treated. After one week, the roots were prepared for root reinforcement and randomly divided into 6 groups (n = 13): positive control group ([PCG] the root canals were not enlarged), negative control group ([NCG] root canals were enlarged, no reinforcement), and in the remaining 4 groups, root canals were enlarged to receive root reinforcement according to a combination of the factors composite resin type (bulk-fill or conventional) and viscosity (flowable or regular). After fiber post cementation, six slices were obtained from each root (2 each from the cervical, middle, and apical thirds). For each group, 7 teeth underwent push-out bond strength testing, and 6 teeth were evaluated for nanoleakage and Vickers microhardness. Bond strength and nanoleakage data were submitted to two-way ANOVA and Tukey's test (α = 0.05), and microhardness data to one-way ANOVA and Tukey's test (α = 0.05).
RESULTS


The root reinforcement groups with regular and flowable bulk-fill composite resins showed statistically superior adhesion results (higher bond strength and less nanoleakage) compared to the negative control in all root regions. Microhardness values were higher in the cervical third followed by the middle third.
CONCLUSION


Regular or flowable bulk-fill composite resins should be chosen for root reinforcement of flared root canals prior to fiber post cementation.",2020,The root reinforcement groups with regular and flowable bulk-fill composite resins showed statistically superior adhesion results (higher bond strength and less nanoleakage) compared to the negative control in all root regions.,['The crowns of 78 uniradicular permanent teeth were removed and the teeth were endodontically treated'],"['positive control group ([PCG] the root canals were not enlarged), negative control group ([NCG] root canals were enlarged, no reinforcement), and in the remaining 4 groups, root canals were enlarged to receive root reinforcement according to a combination of the factors composite resin type (bulk-fill or conventional) and viscosity (flowable or regular']",['Microhardness values'],"[{'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0445111', 'cui_str': 'No reinforcement'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6.0,0.0196454,The root reinforcement groups with regular and flowable bulk-fill composite resins showed statistically superior adhesion results (higher bond strength and less nanoleakage) compared to the negative control in all root regions.,"[{'ForeName': 'Julio Cezar', 'Initials': 'JC', 'LastName': 'Chidoski-Filho', 'Affiliation': ''}, {'ForeName': 'Lucas Pagano', 'Initials': 'LP', 'LastName': 'Camargo', 'Affiliation': ''}, {'ForeName': 'Bruna Fortes', 'Initials': 'BF', 'LastName': 'Bittencourt', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': ''}, {'ForeName': 'Osnara Maria Mongruel', 'Initials': 'OMM', 'LastName': 'Gomes', 'Affiliation': ''}, {'ForeName': 'João Carlos', 'Initials': 'JC', 'LastName': 'Gomes', 'Affiliation': ''}, {'ForeName': 'Giovana Mongruel', 'Initials': 'GM', 'LastName': 'Gomes', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44866']
2565,32666067,Can Fiber-post Placement Reinforce Structurally Compromised Roots?,"PURPOSE


Immature teeth are characterized by short roots, thin root canal walls, and open apices, which makes them prone to fracture. The aim was to investigate whether fiber-post placement had an influence on the fracture resistance of endodontically treated immature teeth.
MATERIALS AND METHODS


To simulate immature teeth, the apical third of 20 intact mandibular premolars was resected. After the access cavity was prepared, root canals and apices were enlarged. A 4-mm apical barrier was placed using calcium-silicate based material (Biodentine, Septodont). The teeth were then randomly assigned to two groups (n = 10). Root canals in group 1 were sealed using Acroseal (Septodont, France) and gutta-percha, followed by composite resin for the coronal restoration (Evetric, Ivoclar Vivadent). In group 2, fiber posts (FRC Postec Plus, Ivoclar Vivadent) were luted using self-adhesive composite cement (SpeedCEM Plus, Ivoclar Vivadent), followed by the same coronal restoration. The teeth were then subjected to fatigue and static load testing.
RESULTS


The average loads (± SD) that led to tooth fracture were: 401.40 ± 296.83 N in group 1 and 636.20 ± 204.95 N in group 2. Unfavorable fractures were noted in 9 specimens from group 1 and in 7 specimens in group 2. No statistically significant difference in fracture resistance or fracture mode was found between the groups.
CONCLUSION


Fiber-post placement had no significant influence on the fracture resistance of endodontically treated immature teeth.",2020,"No statistically significant difference in fracture resistance or fracture mode was found between the groups.
",[],"['fiber posts (FRC Postec Plus, Ivoclar Vivadent', 'fiber-post placement']","['average loads (± SD', 'fracture resistance or fracture mode', 'fracture resistance', 'Unfavorable fractures']",[],"[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0016815', 'cui_str': 'Functional residual capacity'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0338739,"No statistically significant difference in fracture resistance or fracture mode was found between the groups.
","[{'ForeName': 'Uros', 'Initials': 'U', 'LastName': 'Josic', 'Affiliation': ''}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Radovic', 'Affiliation': ''}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Juloski', 'Affiliation': ''}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Beloica', 'Affiliation': ''}, {'ForeName': 'Miljana', 'Initials': 'M', 'LastName': 'Popovic', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Alil', 'Affiliation': ''}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Mandic', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44872']
2566,32666202,Pilot study of tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add-on therapy in Japanese patients with chronic hepatitis B.,"BACKGROUND


A prospective pilot study of tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (P-IFN) add-on therapy was conducted to evaluate its efficacy in reducing viral antigen levels in Japanese patients with chronic hepatitis B (UMIN 000020179).
METHODS


Patients with chronic hepatitis B receiving maintenance TDF therapy and exhibiting hepatitis B surface antigen (HBsAg) level > 800 IU/ml were divided into two arms. P-IFN was added for 48 weeks in the add-on arm (n = 32), while TDF monotherapy was maintained in the control arm (n = 51). Both groups were followed for 96 weeks after baseline measurements.
RESULTS


Almost all patients in the control arm displayed a slow and constant reduction in HBsAg during follow-up. In contrast, roughly half of the add-on arm exhibited a sharp decline in HBsAg during P-IFN administration, which disappeared after halting P-IFN. At 96 weeks after baseline, 41% (13/32) of patients in the add-on arm had shown a rapid decrease in HBsAg, versus 2% (1/51) in the control arm (p < 0.001). Add-on therapy and increased cytotoxic T-cell response were significant factors associated with a rapid decrease in HBsAg according to multivariate analysis. In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.
CONCLUSIONS


TDF and P-IFN add-on therapy in Japanese patients with chronic hepatitis B facilitated rapid decreases in HBsAg and HBcrAg. Further studies are needed to improve early HBsAg clearance rate.",2020,"In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.
","['Japanese patients with chronic hepatitis B', 'Japanese patients with chronic hepatitis B (UMIN 000020179', 'Patients with chronic hepatitis B receiving maintenance TDF therapy and exhibiting hepatitis B surface antigen (HBsAg) level\u2009>\u2009800\xa0IU']","['tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add', 'TDF monotherapy', 'tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (P-IFN', 'TDF and P-IFN']","['HBsAg', 'slow and constant reduction in HBsAg', 'cytotoxic T-cell response', 'viral antigen levels', 'higher HB core-related antigen (HBcrAg) level']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0021734', 'cui_str': 'Interferon Alfa-2a'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0003342', 'cui_str': 'Viral antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}]",,0.0593133,"In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.
","[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nishiguchi', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hirayuki', 'Initials': 'H', 'LastName': 'Enomoto', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Shinkai', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Okuse', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki, Japan.'}, {'ForeName': 'Jong-Hon', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': 'Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Shiho', 'Initials': 'S', 'LastName': 'Miyase', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kumamoto Shinto General Hospital, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yatsuhashi', 'Affiliation': 'The Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Nagaoka', 'Affiliation': 'The Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Enomoto', 'Affiliation': 'Department of Hepatology, Osaka City University Medical School, Osaka, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Gastroenterology, Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takaguchi', 'Affiliation': 'Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.'}, {'ForeName': 'Kiyoaki', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Masaki', 'Affiliation': 'Department of Gastroenterology and Neurology, Kagawa University School of Medicine, Kagawa, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Morihara', 'Affiliation': 'Department of Gastroenterology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tsuge', 'Affiliation': 'Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Chayama', 'Affiliation': 'Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Fusao', 'Initials': 'F', 'LastName': 'Ikeda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Tatehiro', 'Initials': 'T', 'LastName': 'Kagawa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Yasuteru', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Hepatology, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Division of Virology, Department of Infection and Immunity, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Tanaka', 'Affiliation': 'Department for the Promotion of Regional Medicine, Shinshu University School of Medicine, Asahi 3-1-1, Matsumoto, 390-8621, Japan. etanaka@shinshu-u.ac.jp.'}]",Journal of gastroenterology,['10.1007/s00535-020-01707-6']
2567,32661193,Feasibility of computer-generated telephonic message-based follow-up system among healthcare workers with diabetes: a randomized controlled trial.,"INTRODUCTION


To assess the feasibility of computer-generated educational messaging system in healthcare workers of a tertiary care hospital. The secondary objectives were glycemic control, patient satisfaction and adherence to lifestyle modifications.
RESEARCH DESIGN AND METHODS


Single-center parallel-group open-labeled randomized controlled trial with computer generated block randomization.
SETTING


Healthcare workers with diabetes working in Christian Medical College Vellore, Tamil Nadu.
PARTICIPANTS


431 assessed, 341 met the selection criteria, 320 participants were randomized and 161 were taken into intervention arm and 159 in the control arm.
INTERVENTION


Computer-generated short message service (SMS) based on transtheoretical model of behavioral change, 2 messages per week for 3 months, along with standard of care diabetic care. Messages had educational material regarding healthy eating habits and exercise and these messages were sent twice weekly. The messages were scheduled via an automatic calendar in a way that each subject in the intervention arm received 15 educational messages per month.Control group received only standard of care diabetic care which included dietary advice, exercise regimen and diabetic medications under supervision of their physician every 3 months.
FOLLOW-UP


6 months.
RESULTS


95.65% of people in the intervention arm (n=154) received regular messages, out of which 93.17% read the messages regularly. 80.12% acted on the messages. 93.17% felt more satisfied with their healthcare.While both groups showed improvement in body mass index (BMI) and hemoglobin A1c (HbA1c), the difference was greater in the intervention with regard to both decrease in BMI (-0.6, p<0.001) and HBA1c (-0.48, p<0.001).
CONCLUSIONS


SMS-based education system is feasible in improving healthcare among healthcare workers with diabetes. It improves patient satisfaction, adherence and improves healthcare among individuals with diabetes by decreasing their BMI and decreasing HbA1c.",2020,"95.65% of people in the intervention arm (n=154) received regular messages, out of which 93.17% read the messages regularly.","['healthcare workers with diabetes', '431 assessed, 341 met the selection criteria, 320 participants were randomized and 161 were taken into intervention arm and 159 in the control arm', 'healthcare workers of a tertiary care hospital', 'Healthcare workers with diabetes working in Christian Medical College Vellore, Tamil Nadu']","['SMS-based education system', 'computer-generated telephonic message-based follow-up system', 'Computer-generated short message service (SMS', 'Control group received only standard of care diabetic care which included dietary advice, exercise regimen and diabetic medications under supervision of their physician every 3 months', 'computer-generated educational messaging system']","['glycemic control, patient satisfaction and adherence to lifestyle modifications', 'BMI', 'patient satisfaction, adherence and improves healthcare', 'body mass index (BMI) and hemoglobin A1c (HbA1c']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0150544', 'cui_str': 'Diabetic care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",320.0,0.0975523,"95.65% of people in the intervention arm (n=154) received regular messages, out of which 93.17% read the messages regularly.","[{'ForeName': 'Mahima', 'Initials': 'M', 'LastName': 'Sadanshiv', 'Affiliation': 'General Medicine, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India msadanshiv@gmail.com.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Jeyaseelan', 'Affiliation': 'Biostatistics, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Kirupakaran', 'Affiliation': 'Staff Student Health Service, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Sonwani', 'Affiliation': 'Padhar Hospital, Betul, Madhya Pradesh, India.'}, {'ForeName': 'Thambu David', 'Initials': 'TD', 'LastName': 'Sudarsanam', 'Affiliation': 'Internal Medicine, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001237']
2568,32661293,Competitiveness and individual characteristics: a double-blind placebo-controlled study using oxytocin.,"Oxytocin-enhanced prosocial behaviour depends on individual characteristics. This study investigated the relationship between oxytocin and competitiveness, which is another important social trait and predicts economic and social outcomes. In this double-blind, randomized, and placebo-controlled study of 192 male participants, we examined whether oxytocin moderates competitiveness and whether the effect of oxytocin on competitiveness is amplified in individuals with autistic traits. While our results show no relationship between oxytocin and competitiveness, we observed suggestive patterns: albeit not significantly, oxytocin reduced and enhanced competitiveness among participants without autistic traits and among their counterparts with autistic traits, respectively.",2020,"While our results show no relationship between oxytocin and competitiveness, we observed suggestive patterns: albeit not significantly, oxytocin reduced and enhanced competitiveness among participants without autistic traits and among their counterparts with autistic traits, respectively.","['192 male participants', 'individuals with autistic traits']","['oxytocin', 'Oxytocin', 'placebo']",[],"[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],192.0,0.277588,"While our results show no relationship between oxytocin and competitiveness, we observed suggestive patterns: albeit not significantly, oxytocin reduced and enhanced competitiveness among participants without autistic traits and among their counterparts with autistic traits, respectively.","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kurokawa', 'Affiliation': 'School of Economics and Management, University of Hyogo, 8-2-1 Gakuen-nishi-machi, Nishi-ku, Kobe, Hyogo, 651-2197, Japan. kurokawa@em.u-hyogo.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kinari', 'Affiliation': 'Hirao School of Management, Konan University, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okudaira', 'Affiliation': 'Doshisha Business School, Doshisha University, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Tsubouchi', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Yoshimichi', 'Initials': 'Y', 'LastName': 'Sai', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Higashida', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Ohtake', 'Affiliation': 'Department of Economics, Osaka University, Toyonaka, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-68445-w']
2569,32662374,Changing parental depression and sensitivity: Randomized clinical trial of ABC's effectiveness in the community.,"Attachment and Biobehavioral Catch-up (ABC) demonstrates efficacy in improving parent and child outcomes, with preliminary evidence for effectiveness in community settings. The objective of this study was to assess the effectiveness of a community-based ABC implementation in improving parent outcomes as well as to examine potential mediators and moderators of intervention effectiveness. Two hundred parents and their 5- to 21-month-old infants recruited from an urban community were randomly assigned to receive ABC or be placed on a waitlist. The majority of participants had a minority racial or ethnic background. Before intervention, parents completed questionnaires about sociodemographic risk and adverse childhood experiences. At both baseline and follow-up, parents reported depression symptoms and were video-recorded interacting with their infant, which was coded for sensitivity. The ABC intervention predicted significant increases in parental sensitivity and, among parents who completed the intervention, significant decreases in depression symptoms. Changes in parental depression symptoms did not significantly mediate the intervention effects on sensitivity. Risk variables did not moderate the intervention effects. The results indicate that ABC shows promise for improving parent outcomes in community settings, supporting dissemination.",2020,"The ABC intervention predicted significant increases in parental sensitivity and, among parents who completed the intervention, significant decreases in depression symptoms.",['Two hundred parents and their 5- to 21-month-old infants recruited from an urban community'],"['Attachment and Biobehavioral Catch-up (ABC', 'ABC', 'community-based ABC implementation']","['depression symptoms', 'parental sensitivity', 'parental depression symptoms']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",200.0,0.0733428,"The ABC intervention predicted significant increases in parental sensitivity and, among parents who completed the intervention, significant decreases in depression symptoms.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Perrone', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Imrisek', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Erasma', 'Initials': 'E', 'LastName': 'Monticciolo', 'Affiliation': 'Power of Two, Brooklyn, NY, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}]",Development and psychopathology,['10.1017/S0954579420000310']
2570,32662661,Evaluation of the potential complications of surgical wound drainage in primary total hip arthroplasty: a prospective controlled double-blind study.,"BACKGROUND


The routine use of postoperative wound drainage following total hip arthroplasty (THA) to avoid the creation of excessive haematomas is controversial because of the potential risk of blood loss and wound infection.
METHODS


In a prospective double-blind controlled study, 2 groups of patients with hip joint osteoarthritis were operated with primary THA, 1 with surgical wound negative pressure drainage (Group 1 - 635 patients) and the other without (Group 2 - 527 patients). Postoperative blood haemoglobin and haematocrit levels, the necessity for blood transfusion, values of the potential infection markers (serum C-reactive protein values and erythrocyte sedimentation rate), postoperative pain level (according to the VAS scale) and functional outcome (according to Harris Hip Score [HHS] and SF-36 scores) at 12 months postoperatively were compared.
RESULTS


A significantly higher drop in blood haemoglobin and haematocrit values was observed in the Group 1 patients (mean drop of 2.2 gr/dl ± 0.25 vs. 1.6 gr/dl ± 0.35 and mean drop of 16% ± 4.0 vs. 11% ± 3.0, respectively,  p   <  0.01, paired  t  test). The need for blood transfusion was significantly higher in the Group 1 patients (4.9% vs. 3.9%,  p   <  0.05,  t  test). The severity of pain (VAS scale) on the first day after the operation was significantly lower in the Group 1 patients ( p  < 0.05,  t test ), but overall, in both groups it was of low intensity (VAS <3). A similar postoperative wound infection rate was observed in both groups (0.4%). HHS and SF-36 scores were similar in both groups.
CONCLUSIONS


The drainage of surgical wounds following primary THA due to hip osteoarthritis has a low added value and might cause an increased requirement for blood transfusion.",2020,"The severity of pain (VAS scale) on the first day after the operation was significantly lower in the Group 1 patients ( p  < 0.05,  t test ), but overall, in both groups it was of low intensity (VAS <3).","['2 groups of patients with hip joint osteoarthritis were operated with primary THA, 1 with surgical wound negative pressure drainage (Group 1 - 635 patients) and the other without (Group 2 - 527 patients', 'primary total hip arthroplasty']","['postoperative wound drainage following total hip arthroplasty (THA', 'surgical wound drainage']","['need for blood transfusion', 'postoperative wound infection rate', 'severity of pain (VAS scale', 'Postoperative blood haemoglobin and haematocrit levels, the necessity for blood transfusion, values of the potential infection markers (serum C-reactive protein values and erythrocyte sedimentation rate), postoperative pain level (according to the VAS scale) and functional outcome (according to Harris Hip Score [HHS] and SF-36 scores', 'blood haemoglobin and haematocrit values', 'HHS and SF-36 scores']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C4517805', 'cui_str': '527'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0406834', 'cui_str': 'Wound discharge finding'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041711', 'cui_str': 'United States. Dept. of Health and Human Services'}]",,0.0530174,"The severity of pain (VAS scale) on the first day after the operation was significantly lower in the Group 1 patients ( p  < 0.05,  t test ), but overall, in both groups it was of low intensity (VAS <3).","[{'ForeName': 'Alexey V', 'Initials': 'AV', 'LastName': 'Lychagin', 'Affiliation': 'I.M. Sechenov University, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Nahum', 'Initials': 'N', 'LastName': 'Rosenberg', 'Affiliation': 'Technion Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Andrey A', 'Initials': 'AA', 'LastName': 'Gritsyuk', 'Affiliation': 'I.M. Sechenov University, First Moscow State Medical University, Moscow, Russia.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700020941749']
2571,32662699,Can Brief Email Guidance Enhance the Effects of an Internet Intervention for People with Problematic Alcohol Use? A Randomized Controlled Trial.,"BACKGROUND


Some research suggests that internet interventions aimed at people with problematic alcohol use are more effective when provided with guidance from a therapist or coach.  Purpose/Objectives:  This trial intended to compare the effects of a previously evaluated internet intervention for people with problematic alcohol use when delivered with or without brief email guidance.  Methods:  Using online advertising, 238 participants, 18 years or older, were recruited and randomized to receive access to the Internet intervention Alcohol Help Center with or without brief email guidance from a health educator. The guidance consisted of at least four structured, slightly individualized emails delivered during the first two weeks after randomization. Participants were followed up at 3 and 6 months.  Results:  Number of log-ins did not differ significantly between groups throughout the follow-up period. The follow-up rate at 6 months was 47.0%. Generalized estimating equations run on the primary (standard drinks in preceding week/heavy drinking days in preceding week) and secondary outcome variables (AUDIT, AUDIT-C, quality of life) revealed no significant differences between the interventions on any of the outcomes.  Conclusions/Importance:  The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.",2020,The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.,"['people with problematic alcohol', 'People with Problematic Alcohol Use', 'problem drinkers', '238 participants, 18\u2009years or older']","['Internet Intervention', 'internet intervention', 'Internet intervention Alcohol Help Center with or without brief email guidance from a health educator']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}]",[],238.0,0.0894453,The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sundström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatric Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schell', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Wardell', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Godinho', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Cunningham', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}]",Substance use & misuse,['10.1080/10826084.2020.1788087']
2572,32662862,Effect of Maternal Docosahexaenoic Acid Supplementation on Bronchopulmonary Dysplasia-Free Survival in Breastfed Preterm Infants: A Randomized Clinical Trial.,"Importance


Maternal docosahexaenoic acid (DHA) supplementation may prevent bronchopulmonary dysplasia, but evidence remains inconclusive.
Objective


To determine whether maternal DHA supplementation during the neonatal period improves bronchopulmonary dysplasia-free survival in breastfed infants born before 29 weeks of gestation.
Design, Setting, and Participants


Superiority, placebo-controlled randomized clinical trial at 16 Canadian neonatal intensive care units (June 2015-April 2018 with last infant follow-up in July 2018). Lactating women who delivered before 29 weeks of gestation were enrolled within 72 hours of delivery. The trial intended to enroll 800 mothers, but was stopped earlier.
Interventions


There were 232 mothers (273 infants) assigned to oral capsules providing 1.2 g/d of DHA from randomization to 36 weeks' postmenstrual age and 229 mothers (255 infants) assigned to placebo capsules.
Main Outcomes and Measures


The primary outcome was bronchopulmonary dysplasia-free survival in infants at 36 weeks' postmenstrual age. There were 22 secondary outcomes, including mortality and bronchopulmonary dysplasia.
Results


Enrollment was stopped early due to concern for harm based on interim data from this trial and from another trial that was published during the course of this study. Among 461 mothers and their 528 infants (mean gestational age, 26.6 weeks [SD, 1.6 weeks]; 253 [47.9%] females), 375 mothers (81.3%) and 523 infants (99.1%) completed the trial. Overall, 147 of 268 infants (54.9%) in the DHA group vs 157 of 255 infants (61.6%) in the placebo group survived without bronchopulmonary dysplasia (absolute difference, -5.0% [95% CI, -11.6% to 2.6%]; relative risk, 0.91 [95% CI, 0.80 to 1.04], P = .18). Mortality occurred in 6.0% of infants in the DHA group vs 10.2% of infants in the placebo group (absolute difference, -3.9% [95% CI, -6.8% to 1.4%]; relative risk, 0.61 [95% CI, 0.33 to 1.13], P = .12). Bronchopulmonary dysplasia occurred in 41.7% of surviving infants in the DHA group vs 31.4% in the placebo group (absolute difference, 11.5% [95% CI, 2.3% to 23.2%]; relative risk, 1.36 [95% CI, 1.07 to 1.73], P = .01). Of 22 prespecified secondary outcomes, 19 were not significantly different.
Conclusions and Relevance


Among breastfed preterm infants born before 29 weeks of gestation, maternal docosahexaenoic acid supplementation during the neonatal period did not significantly improve bronchopulmonary dysplasia-free survival at 36 weeks' postmenstrual age compared with placebo. Study interpretation is limited by early trial termination.
Trial Registration


ClinicalTrials.gov Identifier: NCT02371460.",2020,"Mortality occurred in 6.0% of infants in the DHA group vs 10.2% of infants in the placebo group (absolute difference, -3.9% [95% CI, -6.8% to 1.4%]; relative risk, 0.61 [95% CI, 0.33 to 1.13], P = .12).","[""232 mothers (273 infants) assigned to oral capsules providing 1.2 g/d of DHA from randomization to 36 weeks' postmenstrual age and 229 mothers (255 infants) assigned to"", 'enroll 800 mothers, but was stopped earlier', 'Lactating women who delivered before 29 weeks of gestation were enrolled within 72 hours of delivery', 'breastfed preterm infants born before 29 weeks of gestation, maternal', 'Breastfed Preterm Infants', 'breastfed infants born before 29 weeks of gestation', '461 mothers and their 528 infants (mean gestational age, 26.6 weeks', '375 mothers (81.3%) and 523 infants (99.1%) completed the trial', '16 Canadian neonatal intensive care units (June 2015-April 2018 with last infant follow-up in July 2018']","['Maternal docosahexaenoic acid (DHA) supplementation', 'placebo capsules', 'maternal DHA supplementation', 'Maternal Docosahexaenoic Acid Supplementation', 'docosahexaenoic acid supplementation', 'placebo']","['bronchopulmonary dysplasia', 'Bronchopulmonary dysplasia', 'mortality and bronchopulmonary dysplasia', 'Mortality', 'Bronchopulmonary Dysplasia-Free Survival', 'bronchopulmonary dysplasia-free survival']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0991533', 'cui_str': 'Oral capsule'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}]","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.79265,"Mortality occurred in 6.0% of infants in the DHA group vs 10.2% of infants in the placebo group (absolute difference, -3.9% [95% CI, -6.8% to 1.4%]; relative risk, 0.61 [95% CI, 0.33 to 1.13], P = .12).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Marc', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Piedboeuf', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lacaze-Masmonteil', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fraser', 'Affiliation': 'Department of Obstetrics and Gynecology, Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Mâsse', 'Affiliation': 'School of Public Health, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Mohamed', 'Affiliation': 'Department of Pediatrics, Université de Montréal, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Mosarrat', 'Initials': 'M', 'LastName': 'Qureshi', 'Affiliation': 'Division of Neonatology, Royal Alexandra Hospital, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jehier', 'Initials': 'J', 'LastName': 'Afifi', 'Affiliation': 'Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Lemyre', 'Affiliation': ""Division of Neonatology, Children's Hospital of Eastern Ontario, Ottawa, Canada.""}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Caouette', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bartholomew', 'Affiliation': 'Department of Neonatology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anne Monique', 'Initials': 'AM', 'LastName': 'Nuyt', 'Affiliation': 'Department of Pediatrics, Université de Montréal, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Julien', 'Affiliation': 'Department of Endocrinology and Nephrology, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lucas', 'Affiliation': 'Department of Social and Preventive Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Hôpital du Saint-Sacrement, Quebec City, Quebec, Canada.'}, {'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'Perreault', 'Affiliation': ""Division of Neonatology, Montréal Children's Hospital, McGill University, Montreal, Quebec, Canada.""}, {'ForeName': 'Lannae', 'Initials': 'L', 'LastName': 'Strueby', 'Affiliation': 'Department of Pediatrics, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Zenon', 'Initials': 'Z', 'LastName': 'Cieslak', 'Affiliation': 'Department of Pediatrics, Royal Columbian Hospital, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Yusuf', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Pelligra', 'Affiliation': 'Department of Maternity Care and Pediatrics, Victoria General Hospital, Island Health, Victoria, British Columbia, Canada.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Massé', 'Affiliation': 'Department of Pediatrics, Université de Sherbrooke, Hôpital Fleurimont, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Larsen', 'Affiliation': 'Faculty of Agricultural, Life, and Environmental Sciences, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'de Cabo', 'Affiliation': 'Department of Pediatrics and Child Health, Max Rady School of Medicine, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Ruth', 'Affiliation': 'Department of Pediatrics and Child Health, Max Rady School of Medicine, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khurshid', 'Affiliation': ""Department of Pediatrics, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Pascal M', 'Initials': 'PM', 'LastName': 'Lavoie', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of British Columbia, Vancouver, Canada.'}]",JAMA,['10.1001/jama.2020.8896']
2573,32506446,Effects of higher and more frequent dosing of alglucosidase alfa and immunomodulation on long-term clinical outcome of classic infantile Pompe patients.,"The aim of this study was to compare the long-term outcome of classic infantile Pompe patients treated with 20 mg/kg alglucosidase alfa every other week (eow) to those treated with 40 mg/kg/week, and to study the additional effect of immunomodulation. Six patients received 20 mg/kg eow and twelve 40 mg/kg/week. Five patients were cross-reactive immunologic material (CRIM)-negative, two in the 20 mg, three in the 40 mg group. We compared (ventilator-free) survival, motor outcome, infusion associated reactions (IARs), and antibody formation. From 2012 on patients >2 months in the 40 mg group also received immunomodulation with rituximab, methotrexate, and intravenous immunoglobulin (IVIG) in an enzyme replacement therapy (ERT)-naïve setting. Survival was 66% in the 20 mg group and 92% in the 40 mg group. Ventilator-free survival was 50% and 92%. Both CRIM-negative patients in the 20 mg group died, whereas all three are alive in the 40 mg group. In the 20 mg group, 67% learned to walk compared with 92% in the 40 mg group. At the age of 3 years, 33% and 92% were able to walk. Peak antibody titers ranged from 1:1250 to 1:31 250 in the 20 mg group and from 1:250 to 1:800 000 in the 40 mg group. Five patients of the 40 mg group of whom two CRIM-negative also received immunomodulation. B-cell recovery was observed between 5.7 and 7.9 months after the last dose of rituximab. After B-cell recovery titers of patients with and without immunomodulation were similar (ranges 1:6 250-1:800 000 and 1:250-1:781 250). This study shows that classic infantile patients treated with 40 mg/kg/week from the start to end have a better (ventilator-free) survival and motor outcome. Immunomodulation did not prevent antibody formation in our study.",2020,"We compared (ventilator-free) survival, motor outcome, infusion associated reactions (IARs), and antibody formation.",['classic infantile Pompe patients'],"['20\u2009mg/kg alglucosidase alfa', 'rituximab', 'immunomodulation with rituximab, methotrexate, and intravenous immunoglobulin (IVIG', 'alglucosidase alfa and immunomodulation']","['Peak antibody titers', 'Survival', 'Ventilator-free survival', 'B-cell recovery', 'antibody formation', 'ventilator-free) survival, motor outcome, infusion associated reactions (IARs), and antibody formation']","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1695579', 'cui_str': 'alglucosidase alfa'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1963758', 'cui_str': 'Immunomodulatory therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",5.0,0.0312592,"We compared (ventilator-free) survival, motor outcome, infusion associated reactions (IARs), and antibody formation.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Poelman', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Pediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan J A', 'Initials': 'JJA', 'LastName': 'van den Dorpel', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Pediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hoogeveen-Westerveld', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Clinical Genetics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Johanna M P', 'Initials': 'JMP', 'LastName': 'van den Hout', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Pediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Lianne J', 'Initials': 'LJ', 'LastName': 'van der Giessen', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Pediatric Physiotherapy, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Nadine A M E', 'Initials': 'NAME', 'LastName': 'van der Beek', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Pediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'W W M Pim', 'Initials': 'WWMP', 'LastName': 'Pijnappel', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Clinical Genetics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Ans T', 'Initials': 'AT', 'LastName': 'van der Ploeg', 'Affiliation': 'Center for Lysosomal and Metabolic Diseases, Department of Pediatrics, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12268']
2574,31654188,Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study).,"PURPOSE


To describe the natural history of diabetic macular edema (DME) with respect to best-corrected visual acuity (BCVA) and central retinal thickness (CRT) outcomes and to identify baseline patient characteristics and systemic factors associated with improvement or worsening of outcomes in sham-treated patients.
METHODS


The study population was sham-treated patients (n = 350) in the 3-year MEAD registration study of dexamethasone intravitreal implant for treatment of DME. Patients had center-involved DME and received sham intravitreal injections in the study eye at ≥ 6-month intervals. Potential prognostic factors for outcomes were evaluated using multiple linear regression analysis.
RESULTS


Visual and anatomic outcomes were poorer in patients who left the study early (n = 198) than in study completers (n = 152). Mean change in BCVA from baseline at the last visit with available data was + 0.9 letters; 37.5% of patients had no change in BCVA, 23.2% had gained > 10 letters, and 16.0% had lost > 10 letters. Older age and baseline diabetic retinopathy score > 6 were associated with worse BCVA outcomes; thicker baseline CRT and larger number of hypertension medications used were associated with larger reductions in CRT during the study.
CONCLUSIONS


BCVA and CRT outcomes were variable in this population of DME patients with generally good glycemic control. In DME patients without active treatment, older age and baseline diabetic retinopathy score > 6 were associated with less improvement in BCVA; thicker baseline CRT and a larger number of antihypertensive medications used predicted better improvement in CRT.
TRIAL REGISTRATION


The MEAD study trials are registered at ClinicalTrials.gov with the identifiers NCT00168337 and NCT00168389.",2019,"In DME patients without active treatment, older age and baseline diabetic retinopathy score > 6 were associated with less improvement in BCVA; thicker baseline CRT and a larger number of antihypertensive medications used predicted better improvement in CRT.
","['sham-treated patients', 'diabetic macular edema (DME', 'Older age and baseline diabetic retinopathy score']",['dexamethasone intravitreal implant for treatment of DME'],"['corrected visual acuity (BCVA) and central retinal thickness (CRT) outcomes', 'older age and baseline diabetic retinopathy score', 'worse BCVA outcomes; thicker baseline CRT and larger number of hypertension medications', 'Mean change in BCVA', 'CRT outcomes']","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C2702454', 'cui_str': 'Dexamethasone Drug Implant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.324831,"In DME patients without active treatment, older age and baseline diabetic retinopathy score > 6 were associated with less improvement in BCVA; thicker baseline CRT and a larger number of antihypertensive medications used predicted better improvement in CRT.
","[{'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea. yhyoon@amc.seoul.kr.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retina-Vitreous Associates Medical Group, Los Angeles, CA, USA.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, IN, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'Hospital San Raffaele, University Vita-Salute, Milan, Italy.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Vision Institute, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Zhanying', 'Initials': 'Z', 'LastName': 'Bai', 'Affiliation': 'Allergan plc, Bridgewater, NJ, USA.'}, {'ForeName': 'Yehia', 'Initials': 'Y', 'LastName': 'Hashad', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-019-04464-2']
2575,31705570,Two-dimensional speckle-tracking strain detects subclinical cardiotoxicity in older patients treated for acute myeloid leukemia.,"BACKGROUND


Patients with acute myeloid leukemia (AML) are surviving longer. There are no data on changes in myocardial mechanics from standard of care low-dose anthracycline-based induction chemotherapy in older patients with AML. The aim of this study was to demonstrate the potential utility of strain imaging in detecting early changes in left ventricular function in this patient population after induction chemotherapy.
METHODS


Thirty two patients enrolled in the ECOG-ACRIN E2906 study (cytarabine and daunorubicin vs clofarabine [Genzyme/Sanofi]) from 2011 to 2014 were evaluated retrospectively. Two-dimensional transthoracic echocardiography (TTE) imaging with Doppler and two-dimensional speckle-tracking echocardiography (2DSTE) using EchoInsight software (Epsilon imaging) were performed before and after induction chemotherapy.
RESULTS


Eighteen patients received cytarabine and daunorubicin (7 + 3) and 14 received clofarabine. The clofarabine group was older than the 7 + 3 cohort (67.8 ± 4.0 vs 63.7 ± 3.8, P = .007). There were no other significant differences in cardiac risk factors between groups. The 7 + 3 group had a decrease in average peak systolic global longitudinal (-19.1 ± 2.8 to -17.2 ± 3.0, P = .01) and circumferential strain (-29.4 ± 6.3 to -23.9 ± 4.3, P = .011). These changes were not demonstrated in the clofarabine group and were not associated with a decline in left ventricular ejection fraction (LVEF).
CONCLUSIONS


In older AML patients, standard cytarabine and daunorubicin chemotherapy causes early changes in global longitudinal and circumferential strain not seen with clofarabine therapy. These findings demonstrate subclinical left ventricular dysfunction after exposure to low cumulative doses of anthracycline-based induction chemotherapy and may help us better identify those patients at risk for adverse long-term cardiovascular outcomes.",2019,"These changes were not demonstrated in the clofarabine group and were not associated with a decline in left ventricular ejection fraction (LVEF).
","['Patients with acute myeloid leukemia (AML', 'older patients with AML', 'two patients enrolled in the ECOG-ACRIN E2906 study', 'patient population after induction chemotherapy', 'Thirty', 'older patients treated for acute myeloid leukemia']","['anthracycline-based induction chemotherapy', 'cytarabine and daunorubicin', 'Two-dimensional speckle-tracking strain', 'clofarabine', 'Two-dimensional transthoracic echocardiography (TTE) imaging with Doppler and two-dimensional speckle-tracking echocardiography (2DSTE) using EchoInsight software (Epsilon imaging', 'cytarabine and daunorubicin vs clofarabine [Genzyme/Sanofi', 'standard cytarabine and daunorubicin chemotherapy', 'clofarabine therapy', 'strain imaging']","['myocardial mechanics', 'average peak systolic global longitudinal', 'circumferential strain', 'cardiac risk factors', 'left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0092777', 'cui_str': 'clofarabine'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0113456', 'cui_str': ""di(1,N(6)-ethenoadenosine)-5',5'''-P(1),P(4)-tetraphosphate""}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]",32.0,0.0385403,"These changes were not demonstrated in the clofarabine group and were not associated with a decline in left ventricular ejection fraction (LVEF).
","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Cascino', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Woo Bin', 'Initials': 'WB', 'LastName': 'Voss', 'Affiliation': 'Department of Cardiology, North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Canaani', 'Affiliation': 'Hematology Division, Chaim Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Furiasse', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Rademaker', 'Affiliation': 'Department of Preventative Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Luger', 'Affiliation': 'Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Altman', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Foran', 'Affiliation': 'Division of Hematology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Litzow', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Division of Hematologic Oncology, Sloan Kettering Memorial Cancer Center, New York, New York.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Rigolin', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Nausheen', 'Initials': 'N', 'LastName': 'Akhter', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}]","Echocardiography (Mount Kisco, N.Y.)",['10.1111/echo.14518']
2576,32661522,Comparative clinical and radiographic evaluation of demineralized freeze-dried bone allograft with and without decortication in the treatment of periodontal intrabony defects: a randomized controlled clinical study.,"OBJECTIVES


Regeneration of intrabony defects is a challenging target of periodontal therapy. The biologic rationale for regeneration not only is based on incorporating the regenerative material, but also takes into consideration the defect's inherent healing capacity. The present study was carried out to evaluate the efficacy of decortication or intramarrow penetration performed with demineralized freeze-dried bone allograft (DFDBA) in the management of intrabony defects.
METHOD AND MATERIALS


Forty chronic periodontitis (stage II and III periodontitis) patients having 40 intrabony defects were randomly assigned into test group (intrabony defect filled with DFDBA after intramarrow penetration along with open flap debridement [OFD+IMP+ DFDBA]) and control group (DFDBA along with open flap debridement [OFD+DFDBA]). Primary outcome measures included probing pocket depth, clinical attachment level, and percentage bone fill (%BF). All parameters were recorded at baseline, 6 months, and 9 months postsurgical follow-up.
RESULTS


Mean reduction in probing depth and gain in clinical attachment level was statistically significantly higher at the interdental defect site in the test group compared to the control group at 9 months follow-up (P = .02 and .04, respectively). In radiographic parameters, statistically significant improvements in defect depth and gain in defect area were found in the test group (P = .00 and .03, respectively). Statistically significant improvements in %BF and linear bone growth (P = .02 and .00, respectively) were also observed in the experimental group (39.47 ± 13.92% and 1.41 ± 0.54 mm) in comparison with the control group (19.29 ± 14.24%, 0.62 ± 0.49 mm).
CONCLUSION


Addition of intramarrow penetration with DFDBA in surgical periodontal therapy may enhance the healing potential of periodontal intrabony defects, as observed by greater improvement in clinical and radiographic outcomes.",2020,"RESULTS


Mean reduction in probing depth and gain in clinical attachment level was statistically significantly higher at the interdental defect site in the test group compared to the control group at 9 months follow-up (P = .02 and .04, respectively).","['Forty chronic periodontitis (stage II and III periodontitis) patients having 40 intrabony defects', 'periodontal intrabony defects']","['demineralized freeze-dried bone allograft (DFDBA', 'demineralized freeze-dried bone allograft with and without decortication', 'test group (intrabony defect filled with DFDBA after intramarrow penetration along with open flap debridement [OFD+IMP+ DFDBA]) and control group (DFDBA along with open flap debridement [OFD+DFDBA']","['healing potential of periodontal intrabony defects', 'BF and linear bone growth', 'probing pocket depth, clinical attachment level, and percentage bone fill (%BF', 'defect depth and gain in defect area', 'probing depth and gain in clinical attachment level']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",40.0,0.0385302,"RESULTS


Mean reduction in probing depth and gain in clinical attachment level was statistically significantly higher at the interdental defect site in the test group compared to the control group at 9 months follow-up (P = .02 and .04, respectively).","[{'ForeName': 'Amanpreet Kaur', 'Initials': 'AK', 'LastName': 'Saini', 'Affiliation': ''}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Tewari', 'Affiliation': ''}, {'ForeName': 'Satish Chander', 'Initials': 'SC', 'LastName': 'Narula', 'Affiliation': ''}, {'ForeName': 'Rajinder Kumar', 'Initials': 'RK', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Tanwar', 'Affiliation': ''}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Sangwan', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44921']
2577,32661682,"Within-group comparisons led to unsubstantiated conclusions in ""Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention Study"".",,2020,,['healthy Swedish females'],[],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.027488,,"[{'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Vorland', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. cvorland@iu.edu.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Mestre', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Sachintha S', 'Initials': 'SS', 'LastName': 'Mendis', 'Affiliation': 'Department of Agricultural and Resource Economics, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. awb1@iu.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02287-0']
2578,32661681,Effects of hesperidin in orange juice on blood and pulse pressures in mildly hypertensive individuals: a randomized controlled trial (Citrus study).,"PURPOSE


To assess the sustained and acute effects, as well as the influence of sustained consumption on the acute effects, of orange juice (OJ) with a natural hesperidin content and hesperidin-enriched OJ (EOJ) on blood (BP) and pulse (PP) pressures in pre- and stage-1 hypertensive individuals.
METHODS


In a randomized, parallel, double-blind, placebo-controlled trial, participants (n = 159) received 500 mL/day of control drink, OJ, or EOJ for 12 weeks. Two dose-response studies were performed at baseline and after 12 weeks.
RESULTS


A single EOJ dose (500 mL) reduced systolic BP (SBP) and PP, with greater changes after sustained treatment where a decrease in diastolic BP (DBP) also occurred (P < 0.05). SBP and PP decreased in a dose-dependent manner relative to the hesperidin content of the beverages throughout the 12 weeks (P < 0.05). OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05). After 12 weeks of EOJ consumption, four genes related to hypertension (PTX3, NLRP3, NPSR1 and NAMPT) were differentially expressed in peripheral blood mononuclear cells (P < 0.05).
CONCLUSION


Hesperidin in OJ reduces SBP and PP after sustained consumption, and after a single dose, the chronic consumption of EOJ enhances its postprandial effect. Decreases in systemic and transcriptomic biomarkers were concomitant with BP and PP changes. EOJ could be a useful co-adjuvant tool for BP and PP management in pre- and stage-1 hypertensive individuals.",2020,OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05).,"['mildly hypertensive individuals', 'participants (n\u2009=\u2009159) received', 'pre- and stage-1 hypertensive individuals']","['500\xa0mL/day of control drink, OJ, or EOJ', 'EOJ', 'orange juice (OJ) with a natural hesperidin content and hesperidin-enriched OJ (EOJ', 'hesperidin', 'placebo']","['OJ and EOJ decreased homocysteine levels', 'hypertension (PTX3, NLRP3, NPSR1 and NAMPT', 'peripheral blood mononuclear cells', 'systemic and transcriptomic biomarkers', 'diastolic BP (DBP', 'reduced systolic BP (SBP) and PP', 'blood and pulse pressures', 'blood (BP) and pulse (PP) pressures', 'SBP and PP']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0019392', 'cui_str': 'Hesperidin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1571622', 'cui_str': 'nicotinamide phosphoribosyltransferase, human'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",,0.134296,OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05).,"[{'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain. anna.pedret@eurecat.org.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Calderón-Pérez', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pla-Pagà', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Companys', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moragas', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Martín-Luján', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ortega', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària-IDIAP Jordi Gol, Tarragona, Spain.""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Romeu', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rubió', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mayneris-Perxachs', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Canela', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Centre for Omic Sciences, Reus, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Puiggrós', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Caimari', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Bas', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Av. de La Universitat, 1, 43204, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Universitat Rovira i Virgili, Facultat de Medicina i Ciències de La Salut, Reus, Spain.'}]",European journal of nutrition,['10.1007/s00394-020-02279-0']
2579,32661703,Combined antisaccade task and transcranial direct current stimulation to increase response inhibition in binge eating disorder.,"Binge eating disorder (BED) is associated with deficient response inhibition. Malfunctioning response inhibition is linked to hypoactivation of the dorsolateral prefrontal cortex (dlPFC), where excitability could be increased by anodal transcranial direct current stimulation (tDCS). Response inhibition can be assessed using an antisaccade task which requires supressing a dominant response (i.e. saccade) towards a newly appearing picture in the visual field. We performed a double-blind, randomised, placebo-controlled proof-of-concept-study in which we combined a food-modified antisaccade task with tDCS in people with BED. We expected task learning and modulatory tDCS effects. Sixteen people were allocated to a 1 mA condition, 15 people to a 2 mA condition. Each participant underwent the food-modified antisaccade task at three measurement points: baseline without stimulation, anodal verum and sham stimulation at the right dlPFC in a crossover design. The error rate and the latencies of correct antisaccades decreased over time. No tDCS effect on the error rate could be observed. Compared to sham stimulation, 2 mA tDCS decreased the latencies of correct antisaccades, whereas 1 mA tDCS increased it. Self-reported binge eating episodes were reduced in the 2 mA condition, while there was no change in the 1 mA condition. Participants demonstrated increased response inhibition capacities by a task learning effect concerning the error rate and latencies of correct antisaccades over time as well as a nonlinear tDCS effect represented by ameliorated latencies in the 2 mA and impaired latencies in the 1 mA condition. The reduction of binge eating episodes might indicate a transfer effect to everyday life. Given that the reduction in binge eating was observed before tDCS administration, this effect could not be the result of neuromodulation. Randomized clinical trials are needed to fully understand this reduction, and to explore the efficacy of a combined antisaccade and tDCS training for BED.",2020,"Compared to sham stimulation, 2 mA tDCS decreased the latencies of correct antisaccades, whereas 1 mA tDCS increased it.","['people with BED', 'binge eating disorder', 'Binge eating disorder (BED', 'Sixteen people were allocated to a 1\xa0mA condition, 15 people to a 2\xa0mA condition']","['placebo', 'combined antisaccade and tDCS training', 'food-modified antisaccade task at three measurement points: baseline without stimulation, anodal verum and sham stimulation at the right dlPFC', 'Combined antisaccade task and transcranial direct current stimulation']","['error rate and latencies of correct antisaccades', 'error rate', 'binge eating episodes', 'Self-reported binge eating episodes', 'binge eating', 'response inhibition capacities', 'latencies of correct antisaccades', 'error rate and the latencies of correct antisaccades']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",16.0,0.108193,"Compared to sham stimulation, 2 mA tDCS decreased the latencies of correct antisaccades, whereas 1 mA tDCS increased it.","[{'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Max', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology and Interventional Neuropsychiatry, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology and Interventional Neuropsychiatry, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany. christian.plewnia@med.uni-tuebingen.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Osianderstraße 5, 72076, Tübingen, Germany.'}, {'ForeName': 'Katrin E', 'Initials': 'KE', 'LastName': 'Giel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Osianderstraße 5, 72076, Tübingen, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Schag', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Osianderstraße 5, 72076, Tübingen, Germany.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-020-01164-5']
2580,32661707,Added value of 3D-vision during robotic pancreatoduodenectomy anastomoses in biotissue (LAEBOT 3D2D): a randomized controlled cross-over trial.,"BACKGROUND


We tested the added value of 3D-vision on procedure time and surgical performance during robotic pancreatoduodenectomy anastomoses in biotissue. Robotic surgery has the advantage of articulating instruments and 3D-vision. Consensus is lacking on the added value of 3D-vision during laparoscopic surgery. Given the improved dexterity with robotic surgery, the added value of 3D-vision may be even less with robotic surgery.
METHODS


In this experimental randomized controlled cross-over trial, 20 surgeons and surgical residents from 5 countries performed robotic pancreaticojejunostomy and hepaticojejunostomy anastomoses in a biotissue organ model using the da Vinci® system and were randomized to start with either 3D- or 2D-vision. Primary endpoint was the time required to complete both anastomoses. Secondary endpoint was the objective structured assessment of technical skill (OSATS; range 12-60) rating; scored by two observers blinded to 3D/2D.
RESULTS


Robotic 3D-vision reduced the combined operative time from 78.1 to 57.3 min (24.6% reduction, p < 0.001; 20.8 min reduction, 95% confidence intervals 12.8-28.8 min). This reduction was consistent for both anastomoses and between surgeons and residents, p < 0.001. Robotic 3D-vision improved OSATS performance by 6.1 points (20.8% improvement, p = 0.003) compared to 2D (39.4 to 45.1 points, ± 5.5).
CONCLUSION


3D-vision has a considerable added value during robotic pancreatoduodenectomy anastomoses in biotissue in both time reduction and improved surgical performance as compared to 2D-vision.",2020,"Robotic 3D-vision improved OSATS performance by 6.1 points (20.8% improvement, p = 0.003) compared to 2D (39.4 to 45.1 points, ± 5.5).
","['robotic pancreatoduodenectomy anastomoses in biotissue', '20 surgeons and surgical residents from 5 countries performed robotic pancreaticojejunostomy and hepaticojejunostomy anastomoses in a biotissue organ model using the da Vinci® system']","['3D-vision', '3D- or 2D-vision', 'Robotic surgery', 'robotic pancreatoduodenectomy anastomoses']","['Robotic 3D-vision improved OSATS performance', 'time required to complete both anastomoses', 'Robotic 3D-vision reduced the combined operative time', 'surgical performance', 'objective structured assessment of technical skill (OSATS; range 12-60) rating']","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0193425', 'cui_str': 'Hepatojejunostomy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",20.0,0.182182,"Robotic 3D-vision improved OSATS performance by 6.1 points (20.8% improvement, p = 0.003) compared to 2D (39.4 to 45.1 points, ± 5.5).
","[{'ForeName': 'Maurice J W', 'Initials': 'MJW', 'LastName': 'Zwart', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Leia R', 'Initials': 'LR', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Balduzzi', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Kosei', 'Initials': 'K', 'LastName': 'Takagi', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Vanlander', 'Affiliation': 'Department of Surgery, University Hospital Ghent, University of Ghent, Ghent, Belgium.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'van den Boezem', 'Affiliation': 'Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Daams', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel', 'Initials': 'C', 'LastName': 'Rosman', 'Affiliation': 'Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Lips', 'Affiliation': 'Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'Moser', 'Affiliation': 'The Pancreas and Liver Institute, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Hogg', 'Affiliation': 'Department of Surgery, Northshore University Health System, Chicago, IL, USA.'}, {'ForeName': 'Olivier R C', 'Initials': 'ORC', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn W J', 'Initials': 'MWJ', 'LastName': 'Stommel', 'Affiliation': 'Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. m.g.besselink@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-020-07732-z']
2581,32663119,Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer.,"PURPOSE


Previous studies of hypofractionated adjuvant whole-breast radiotherapy for early breast cancer established a 15- or 16-fraction (fr) regimen as standard. The FAST Trial (CRUKE/04/015) evaluated normal tissue effects (NTE) and disease outcomes after 5-fr regimens. Ten-year results are presented.
METHODS


Women ≥ 50 years of age with low-risk invasive breast carcinoma (pT1-2 pN0) were randomly assigned to 50 Gy/25 fr (5 weeks) or 30 or 28.5 Gy in 5 fr of 6.0 or 5.7 Gy (1 week). The primary end point was change in photographic breast appearance at 2 and 5 years; secondary end points were physician assessments of NTE and local tumor control. Odds ratios (ORs) from longitudinal analyses compared regimens.
RESULTS


A total of 915 women were recruited from 18 UK centers (2004-2007). Five-year photographs were available for 615/862 (71%) eligible patients. ORs for change in photographic breast appearance were 1.64 (95% CI, 1.08 to 2.49;  P  = .019) for 30 Gy and 1.10 (95% CI, 0.70 to 1.71;  P  = .686) for 28.5 Gy versus 50 Gy. α/β estimate for photographic end point was 2.7 Gy (95% CI, 1.5 to 3.9 Gy), giving a 5-fr schedule of 28 Gy (95% CI, 26 to 30 Gy) estimated to be isoeffective with 50 Gy/25 fr. ORs for any moderate/marked physician-assessed breast NTE (shrinkage, induration, telangiectasia, edema) were 2.12 (95% CI, 1.55 to 2.89;  P  < .001) for 30 Gy and 1.22 (95% CI, 0.87 to 1.72;  P  = .248) for 28.5 Gy versus 50 Gy. With 9.9 years median follow-up, 11 ipsilateral breast cancer events (50 Gy: 3; 30 Gy: 4; 28.5 Gy: 4) and 96 deaths (50 Gy: 30; 30 Gy: 33; 28.5 Gy: 33) have occurred.
CONCLUSION


At 10 years, there was no significant difference in NTE rates after 28.5 Gy/5 fr compared with 50 Gy/25 fr, but NTE were higher after 30 Gy/5 fr. Results confirm the published 3-year findings that a once-weekly 5-fr schedule of whole-breast radiotherapy can be identified that appears to be radiobiologically comparable for NTE to a conventionally fractionated regimen.",2020,"At 10 years, there was no significant difference in NTE rates after 28.5 Gy/5 fr compared with 50 Gy/25 fr, but NTE were higher after 30 Gy/5 fr.","['Early Breast Cancer', 'A total of 915 women were recruited from 18 UK centers (2004-2007', 'Women ≥ 50 years of age with low-risk invasive breast carcinoma (pT1-2 pN0']","['5-Fraction Whole-Breast Radiotherapy', 'FAST', 'hypofractionated adjuvant whole-breast radiotherapy']","['NTE rates', 'normal tissue effects (NTE) and disease outcomes', 'moderate/marked physician-assessed breast NTE (shrinkage, induration, telangiectasia, edema', 'photographic breast appearance', 'physician assessments of NTE and local tumor control', 'Odds ratios (ORs']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}]","[{'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C1286082', 'cui_str': 'Appearance of breast'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",915.0,0.119608,"At 10 years, there was no significant difference in NTE rates after 28.5 Gy/5 fr compared with 50 Gy/25 fr, but NTE were higher after 30 Gy/5 fr.","[{'ForeName': 'Adrian Murray', 'Initials': 'AM', 'LastName': 'Brunt', 'Affiliation': 'Cancer Centre, University Hospitals of North Midlands NHS Trust and Keele University, Stoke-on-Trent, Staffordshire, United Kingdom.'}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Haviland', 'Affiliation': 'Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sydenham', 'Affiliation': 'Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton, London, United Kingdom.'}, {'ForeName': 'Rajiv K', 'Initials': 'RK', 'LastName': 'Agrawal', 'Affiliation': 'Oncology Centre, Lingen Davies Centre, Royal Shrewsbury Hospital, Shrewsbury, Shropshire, United Kingdom.'}, {'ForeName': 'Hafiz', 'Initials': 'H', 'LastName': 'Algurafi', 'Affiliation': 'Oncology Department, Southend University Hospital, Southend, Essex, United Kingdom.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alhasso', 'Affiliation': 'Radiotherapy, Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barrett-Lee', 'Affiliation': 'Velindre Cancer Centre, Velindre Hospital, Cardiff, Wales.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bliss', 'Affiliation': 'Oncology, Torbay Hospital, Torquay, Devon, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bloomfield', 'Affiliation': 'Sussex Cancer Centre, Royal Sussex County Hospital, Brighton, Sussex, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Bowen', 'Affiliation': 'Oncology Centre, Cheltenham General Hospital, Cheltenham, Gloucestershire, United Kingdom.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Donovan', 'Affiliation': 'Centre for Vision, Speech, and Signal Processing, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Exeter Oncology Centre, Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Harnett', 'Affiliation': 'Oncology and Haematology Department, Norfolk and Norwich University Hospital, Norwich, Norfolk, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hogg', 'Affiliation': 'The Cancer Centre, Royal Preston Hospital, Preston, Lancashire, United Kingdom.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, Yorkshire, United Kingdom.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Passant', 'Affiliation': 'Velindre Cancer Centre, Velindre Hospital, Cardiff, Wales.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Quigley', 'Affiliation': ""Oncology Department, Queen's Hospital, Romford, Essex, United Kingdom.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Sherwin', 'Affiliation': 'Department of Oncology and Haematology, Ipswich Hospital, Ipswich, Suffolk, United Kingdom.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Radiotherapy Department, The Christie Hospital, Manchester, Lancashire, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'The Clatterbridge Cancer Centre, Clatterbridge Hospital, Bebington, Wirral, Cheshire, United Kingdom.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Tremlett', 'Affiliation': 'Sussex Cancer Centre, Royal Sussex County Hospital, Brighton, Sussex, United Kingdom.'}, {'ForeName': 'Yat', 'Initials': 'Y', 'LastName': 'Tsang', 'Affiliation': 'RTTQA, Mount Vernon Hospital, Rickmansworth, Middlesex, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Venables', 'Affiliation': 'RTTQA, Mount Vernon Hospital, Rickmansworth, Middlesex, United Kingdom.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Wheatley', 'Affiliation': 'The Sunrise Centre, Royal Cornwall Hospital, Truro, Cornwall, United Kingdom.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton, London, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Yarnold', 'Affiliation': 'Institute of Cancer Research and Royal Marsden Hospital NHS Foundation Trust, Sutton, Surrey, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02750']
2582,32663139,The effects of a novel contextual just-in-time mobile application intervention on sodium intake in adults with hypertension: Results from the LowSalt4Life pilot study.,"BACKGROUND


High dietary sodium intake is a significant public health problem in the U.S. The average sodium intake for Americans is approximately 3,460 mg per day, but current federal guidelines advocate a daily sodium intake of less than 2,300 mg. Higher sodium consumption is associated with increase blood pressure and greater risk of cardiovascular disease.
OBJECTIVE


To evaluate the effect of a just-in-time adaptive mobile application intervention, LowSalt4Life, on reducing sodium intake.
METHODS


In a single center prospective open label randomized controlled trial, 50 patients aged ≥18 years with treated hypertension were randomized (1:1, stratified by gender) to the mobile application (LowSalt4Life) or usual care (No App) for 8 weeks. The primary endpoint was the change in 24-hour urinary sodium excretion estimated from spot urine by the Kawasaki equation, analyzed using unpaired t-testing. Secondary outcomes include the change in sodium intake measured by FFQ and 24-hour urinary sodium excretion, as well as self-reported confidence in following a low sodium diet, and blood pressure (BP).
RESULTS


From baseline to week 8, there was a reduction in the Kawasaki estimated 24-hour urinary sodium excretion calculated from spot urine in the App compared to the No App group (-462±1220 mg vs. 381±1460 mg, p=0.03). The change in 24-hour urinary sodium excretion was -637±1524 mg in the App compared to -322±1485mg in the No App group (p=0.47). The change in estimated sodium intake by 24-hour dietary recall was -1537±2693 vs. -233±2150 mg (p=0.07) and by Food Frequency Questionnaire (FFQ) was -1553±1764 vs. -515±1081 mg (p=0.01) in the App group compared to No App group. The systolic BP change from baseline to week 8 in the App was -7.5 and No App group was -0.7 mmHg (p=0.12), but self-confidence in following a low sodium diet did not change between the groups.
CONCLUSIONS


In a randomized controlled pilot study in adults with hypertension, a contextual just-in-time mobile application intervention demonstrated a greater reduction in dietary sodium intake measured by estimated 24-hour urinary sodium excretion from a spot urine and FFQ compared to control over 8 weeks. There was not a statistically significant difference in self-confidence following a low sodium diet, 24-hour urinary sodium excretion or dietary intake of sodium measured by 24-hour dietary recall compared to control over 8 weeks. A larger clinical trial is warranted to further elucidate the effects of the LowSalt4Life intervention on sodium intake and blood pressure.
CLINICALTRIAL


ClinicalTrials.gov NCT03099343 (https://clinicaltrials.gov/ct2/show/NCT03099343).
INTERNATIONAL REGISTERED REPORT


RR2-10.2196/11282.",2020,"There was not a statistically significant difference in self-confidence following a low sodium diet, 24-hour urinary sodium excretion or dietary intake of sodium measured by 24-hour dietary recall compared to control over 8 weeks.","['adults with hypertension, a contextual just-in-time mobile application intervention', 'adults with hypertension', '50 patients aged ≥18 years with treated hypertension']","['mobile application (LowSalt4Life) or usual care (No App', 'LowSalt4Life intervention', 'novel contextual just-in-time mobile application intervention']","['systolic BP change', 'change in sodium intake measured by FFQ and 24-hour urinary sodium excretion, as well as self-reported confidence in following a low sodium diet, and blood pressure (BP', 'blood pressure', 'self-confidence', 'change in 24-hour urinary sodium excretion', 'dietary sodium intake', '24-hour urinary sodium excretion', 'Kawasaki estimated 24-hour urinary sodium excretion', 'Food Frequency Questionnaire (FFQ', '24-hour urinary sodium excretion or dietary intake of sodium measured by 24-hour dietary recall', 'sodium intake and blood pressure', 'estimated sodium intake by 24-hour dietary recall']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",50.0,0.0406352,"There was not a statistically significant difference in self-confidence following a low sodium diet, 24-hour urinary sodium excretion or dietary intake of sodium measured by 24-hour dietary recall compared to control over 8 weeks.","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dorsch', 'Affiliation': 'University of Michigan College of Pharmacy, 428 Church Street, Ann Arbor, US.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Cornellier', 'Affiliation': 'University of Michigan Health System, Ann Arbor, US.'}, {'ForeName': 'Armella D', 'Initials': 'AD', 'LastName': 'Poggi', 'Affiliation': 'University of Michigan Health System, Ann Arbor, US.'}, {'ForeName': 'Feriha', 'Initials': 'F', 'LastName': 'Bilgen', 'Affiliation': 'University of Michigan Health System, Ann Arbor, US.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'University of Michigan Health System, Ann Arbor, US.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'University of Michigan Health System, Ann Arbor, US.'}, {'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'An', 'Affiliation': 'University of Michigan Health System, Ann Arbor, US.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, US.'}]",JMIR mHealth and uHealth,['10.2196/16696']
2583,32663140,Engagement in an interactive app for self-management of symptoms among patients treated for breast and prostate cancer: results from two randomized controlled trials.,"BACKGROUND


Using mobile technology for symptom management and self-care can improve patient-clinician communication and clinical outcomes in patients with cancer. The interactive app Interaktor has been shown to reduce symptom burden during cancer treatment. It includes symptom assessment, an alert system for contact with health care professionals, access to self-care advice, and visualization of symptom history. It is essential to understand how digital interventions operate and an approach to research this empirically includes to examine engagement by assessing usage and exploring user experiences. Actual usage in correspondence to the intended use - adherence - is an essential factor of engagement.
OBJECTIVE


This study aims to describe engagement with the Interaktor app among patients with breast and prostate cancer during their treatment.
METHODS


All patients from the intervention groups of two separate randomized controlled trials were included. Patients with breast cancer receiving neoadjuvant chemotherapy (n=74) and patients with locally advanced prostate cancer receiving treatment with radiotherapy (n=75). The patients reported their symptoms daily. Sociodemographic and clinical data were obtained from baseline questionnaires and medical records. Logged data usage was retrieved from the server and analyzed descriptively and with multiple regression analysis. Telephone interviews were conducted with patients about their perceptions of using the app and analyzed using content analysis.
RESULTS


The median adherence to daily symptom reporting was 83%. Most patients used the self-care advice and free text message component. Among the patients treated for breast cancer, higher age predicted a higher total number of free text messages sent (P = .04). Among the patients treated for prostate cancer, higher age (P = .01) and higher education level (P = .04), predicted an increase in total views on self-care advice, whilst higher comorbidity (P = .004) predicted a decrease in total views on self-care advice. Being married or living with a partner predicted a higher adherence to daily symptom reporting (P = .02). Daily symptom reporting created feelings of having continuous contact with health care professionals, being acknowledged, and safe. Being contacted by a nurse after a symptom-alert was considered convenient and highly valued. Treatment and time-related aspects influenced engagement. Daily symptom reporting was perceived as particularly meaningful at the beginning of treatment. Requests were made for advice on diet and psychological symptoms, as well as more comprehensive and detailed information as the patient progressed through treatment.
CONCLUSIONS


Patient engagement in the interactive app Interaktor was high. The app promoted patient participation in their care through continuous and convenient contact with health care professionals. The predictive ability of demographic variables differs in between patient groups, but higher age and a higher educational level predicts higher usage of specific app-functions for both patient groups. Patients' experience of relevance and interactivity influence their engagement positively.
CLINICALTRIAL


RCT Breast cancer NCT02479607 RCT Prostate cancer NCT02477137.",2020,"Among the patients treated for prostate cancer, higher age (P = .01) and higher education level (P = .04), predicted an increase in total views on self-care advice, whilst higher comorbidity (P = .004) predicted a decrease in total views on self-care advice.","['n=75', 'patients with cancer', 'patients with breast and prostate cancer during their treatment', 'Patients with breast cancer receiving neoadjuvant chemotherapy (n=74) and patients with locally advanced prostate cancer receiving treatment with', 'patients treated for breast and prostate cancer']",['radiotherapy'],"['median adherence to daily symptom reporting', 'higher education level', 'total number of free text messages sent', 'total views on self-care advice', 'adherence to daily symptom reporting', 'Daily symptom reporting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424933', 'cui_str': 'Higher education'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]",,0.0406111,"Among the patients treated for prostate cancer, higher age (P = .01) and higher education level (P = .04), predicted an increase in total views on self-care advice, whilst higher comorbidity (P = .004) predicted a decrease in total views on self-care advice.","[{'ForeName': 'Marie-Therése', 'Initials': 'MT', 'LastName': 'Crafoord', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Alfred Nobels Allé 23, Stockholm, SE.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fjell', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Alfred Nobels Allé 23, Stockholm, SE.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Sundberg', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Alfred Nobels Allé 23, Stockholm, SE.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Alfred Nobels Allé 23, Stockholm, SE.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Langius-Eklöf', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Alfred Nobels Allé 23, Stockholm, SE.'}]",Journal of medical Internet research,['10.2196/17058']
2584,32663269,Potential of using an implant fixture as a ridge expander for minor ridge augmentation: an ex vivo randomized controlled study.,"To place implants with minimal trauma is what both patient and clinician are looking for. Hence, the aim of this study was to quantify the potential of using an implant fixture as a ridge expander in an underprepared osteotomy. Thirty-eight edentulous sites in 12 human cadaver jaws with ridge widths ranging from 4 to 6 mm and with type 3 or type 4 bone density were randomly assigned into two groups. In the ridge expansion group (RE), each osteotomy was drilled to a width of 2.8 mm and depth of 11.5 mm. In the non-ridge expansion (NE) control group, each osteotomy was drilled to a width of to 3.4 mm and depth of 11.5 mm. A 3.7 mm x 11.5 mm tapered implant was inserted into each site. The ridge width before (RW1) and after (RW2) implant placement as well as the buccal plate thickness (BPT) post-insertion were measured and analyzed. In the RE group, the average RW1 and RW2 were 4.69 ± 0.45 mm and 5.54 ± 0.35 mm respectively, corresponding to a statistically significant ridge expansion of 0.85 mm (p<0.01). In the NE group, no ridge width gain was observed (RW1: 4.79 ± 0.40 mm, RW2: 4.88 ± 0.42 mm). Compared to NE, RE resulted in a statistically greater BPT (1.08 ± 0.28 mm after RE versus 0.71 ± 0.37 mm after NE, p<0.001). Our study determined that it was physically possible to widen a ridge by an average of 0.85 mm by osteotomy underprepation in ridge with type 3 or type 4 bone density, which effectively turned the implant upon insertion into a ridge expander.  The physiological consequences of this method of ridge expansion in a living person must be established before drawing further conclusions about its clinical indications or efficacy.",2020,"Compared to NE, RE resulted in a statistically greater BPT (1.08 ± 0.28 mm after RE versus 0.71 ± 0.37 mm after NE, p<0.001).",['Thirty-eight edentulous sites in 12 human cadaver jaws with ridge widths ranging from 4 to 6 mm and with type 3 or type 4 bone density'],"['NE, RE']","['average RW1 and RW2', 'BPT', 'ridge width gain', 'ridge width before (RW1) and after (RW2) implant placement', 'buccal plate thickness (BPT) post-insertion']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.0428994,"Compared to NE, RE resulted in a statistically greater BPT (1.08 ± 0.28 mm after RE versus 0.71 ± 0.37 mm after NE, p<0.001).","[{'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'University of Michigan Periodontics and Oral Medicine, School of dentistry 1011 N. University Ave. UNITED STATES ann arbor MICHIGAN 48109-1078 University of Michigan.'}, {'ForeName': 'Zhaozhao', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Mendonça', 'Affiliation': ''}, {'ForeName': 'Hsun-Liang', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Sinjab', 'Affiliation': ''}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'University fo Michigan Professor Periodontics & Oral Medicine 1011 North University Avenue UNITED STATES Ann Arbor Michigan 48109 7349360374 7347633383.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00224']
2585,32663386,Acute Consumption of Varied Doses of Cocoa Flavanols Does Not Influence Exercise-Induced Muscle Damage.,"Polyphenol consumption has become a popular method of trying to temper muscle damage. Cocoa flavanols (CF) have attracted attention due to their high polyphenol content and palatability. As such, this study will investigate whether an acute dose of CF can aid recovery following exercise-induced muscle damage. The study was a laboratory-based, randomized, single-blind, nutrient-controlled trial involving 23 participants (13 females and 10 males). Participants were randomized into either control ∼0 mg CF (n = 8, four females); high dose of 830 mg CF (CF830, n = 8, five females); or supra dose of 1,245 mg CF (CF1245, n = 7, four females). The exercise-induced muscle damage protocol consisted of five sets of 10 maximal concentric/eccentric hamstring curls and immediately consumed their assigned drink following completion. To measure muscle recovery, maximal voluntary isometric contraction (MVIC) of the knee flexors at 60° and 30°, a visual analog scale (VAS), and lower-extremity function scale were taken at baseline, immediately, 24-, 48-, and 72-hr postexercise-induced muscle damage. There was a main effect for time for all variables (p < .05). However, no significant differences were observed between groups for all measures (p ≥ .17). At 48 hr, there were large effect sizes between control and CF1245 for MVIC60 (p = .17, d = 0.8); MVIC30 (p = .26, d = 0.8); MVIC30 percentage change (p = .24 d = 0.9); and visual analog scale (p = .25, d = 0.9). As no significant differences were observed following the consumption of CF, there is reason to believe that CF offer no benefit for muscle recovery when ingested acutely.",2020,"At 48 hr, there were large effect sizes between control and CF1245 for MVIC60",['23 participants (13 females and 10 males'],"['Polyphenol consumption', 'exercise-induced muscle damage protocol consisted of five sets of 10 maximal concentric/eccentric hamstring curls and immediately consumed their assigned drink following completion', 'Cocoa flavanols (CF', 'Cocoa Flavanols', 'MVIC60', 'CF', 'control ∼0\xa0mg CF']","['visual analog scale', 'muscle recovery, maximal voluntary isometric contraction (MVIC) of the knee flexors at 60° and 30°, a visual analog scale (VAS), and lower-extremity function scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",23.0,0.128518,"At 48 hr, there were large effect sizes between control and CF1245 for MVIC60","[{'ForeName': 'Liam D', 'Initials': 'LD', 'LastName': 'Corr', 'Affiliation': 'University of Huddersfield.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Field', 'Affiliation': 'University of Huddersfield.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Pufal', 'Affiliation': 'University of Huddersfield.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Killey', 'Affiliation': 'University of Huddersfield.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Clifford', 'Affiliation': 'Loughborough University.'}, {'ForeName': 'Liam D', 'Initials': 'LD', 'LastName': 'Harper', 'Affiliation': 'University of Huddersfield.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Naughton', 'Affiliation': 'University of Huddersfield.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0057']
2586,32663479,The impact of proprioceptive exercises on balance and physical function in institutionalized older adults: A randomized controlled trial.,"OBJECTIVE


To evaluate the efficacy of a proprioceptive exercise program on functional mobility, musculoskeletal endurance, dynamic and static balance, gait, and risk of falls in institutionalized older adults.
DESIGN


A randomized, single-blind, controlled trial.
SETTING


A Spanish nursing home from the Autonomous Community of Extremadura, Spain.
PARTICIPANTS


An initial sample was created by recruiting 148 older adult volunteers. The final sample (n = 42) was randomly divided into two groups.
INTERVENTION


Both the control and experimental group received physical therapy treatment based on a combination of adapted exercises and other physical therapy techniques (physical therapy intervention program) for a period of 12 weeks. This program consisted of 45 minutes (group intervention) plus 100 minutes (individual intervention) a week, for a total of 36 sessions (29 hours). The experimental group also received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions), each session lasting 55 minutes.
MAIN OUTCOME MEASURES


The TUG, Cooper, Tinetti, One-Leg Stance and MORSE scales were used.
RESULTS


ANOVA analysis showed a time x group interaction in TUG scores (F=10.41, P=.002), Cooper test (F=5.94, P=.019), Tinetti scores (F=6.41, P=.015) and MORSE scores (F=5.24, P=.028). Differences between groups were achieved for TUG scores (d=0.76), Tinetti scores (d=1.12), One-Leg Stance test scores (d=0.77) and MORSE scale scores (d=0.85). In the experimental group, within-group analyses showed pre-post-treatment differences for TUG scores (d=0.72), Cooper test scores in meters (d=0.18), Tinetti scores (d=0.60), One-Leg Stance scores (d=0.55), and MORSE scores (d=0.42).
CONCLUSIONS


A proprioceptive exercise program produced significant improvements compared to the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults. This study may help to enhance our understanding of the impact of a specific protocol for a proprioceptive rehabilitation program.",2020,"A proprioceptive exercise program produced significant improvements compared to the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults.","['institutionalized older adults', '148 older adult volunteers', 'A Spanish nursing home from the Autonomous Community of Extremadura, Spain']","['physical therapy treatment based on a combination of adapted exercises and other physical therapy techniques (physical therapy intervention program', 'proprioceptive exercises', 'proprioceptive exercise program', 'proprioceptive training program']","['functional mobility, musculoskeletal endurance, balance, gait, and risk of falls', 'functional mobility, musculoskeletal endurance, dynamic and static balance, gait, and risk of falls', 'Tinetti scores', 'Cooper test', 'MORSE scores', 'TUG scores', 'balance and physical function', 'MORSE scale scores', 'One-Leg Stance test scores', 'time x group interaction in TUG scores', 'One-Leg Stance scores']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029709', 'cui_str': 'Other physical therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",148.0,0.0221272,"A proprioceptive exercise program produced significant improvements compared to the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Espejo-Antúnez', 'Affiliation': 'PhD. Department of Medical-Surgical Therapy. Medicine Faculty. Extremadura University. Avenida de Elvas s/n 06071 Badajoz Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Mármol', 'Affiliation': 'PhD. Department of Physiotherapy. Faculty of Health Sciences. University of Granada. Avenida de la Ilustración, 60 18016 Granada Spain. Electronic address: josemapm@ugr.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Los Ángeles Cardero-Durán', 'Affiliation': 'Department of Medical-Surgical Therapy. Medicine Faculty. Extremadura University. Avd. de Elvas s/n 06071 Badajoz Spain.'}, {'ForeName': 'José Vicente', 'Initials': 'JV', 'LastName': 'Toledo-Marhuenda', 'Affiliation': 'PhD. Department of Pathology and Surgery (Area of Physiotherapy). Medicine Faculty. Miguel Hernández University. Ctra. Alicante-Valencia N 332, 03550. Alicante Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Albornoz-Cabello', 'Affiliation': 'Department of Physiotherapy. University of Sevilla Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.010']
2587,32663638,"Better off at home? Effects of nursing home eligibility on costs, hospitalizations and survival.","Encouraging and helping elderly to postpone a nursing home admission appears to be a win-win that keeps long-term care spending in check and is in line with the target population's preferences, but there is little evidence about its effects. We study the causal impact of nursing home admission eligibility using Dutch administrative data and exploiting variation between randomly assigned assessors in their tendency to grant eligibility for a nursing home admission. We find a drop in medical care use when eligibility is granted, especially in hospital admissions, while total healthcare spending is unaffected. This suggests that postponing an admission may not always be a win-win after all.",2020,"We find a drop in medical care use when eligibility is granted, especially in hospital admissions, while total healthcare spending is unaffected.",[],[],"['costs, hospitalizations and survival']",[],[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0493303,"We find a drop in medical care use when eligibility is granted, especially in hospital admissions, while total healthcare spending is unaffected.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Bakx', 'Affiliation': 'Erasmus School of Health Policy and Management, the Netherlands; Network for Studies on Pensions, Ageing and Retirement, the Netherlands. Electronic address: bakx@eshpm.eur.nl.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Wouterse', 'Affiliation': 'Erasmus School of Health Policy and Management, the Netherlands; Network for Studies on Pensions, Ageing and Retirement, the Netherlands.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'van Doorslaer', 'Affiliation': 'Erasmus School of Health Policy and Management, the Netherlands; Network for Studies on Pensions, Ageing and Retirement, the Netherlands; Erasmus School of Economics, Erasmus University Rotterdam, the Netherlands; Tinbergen Institute, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Network for Studies on Pensions, Ageing and Retirement, the Netherlands; RIVM National Institute for Public Health and the Environment, the Netherlands.'}]",Journal of health economics,['10.1016/j.jhealeco.2020.102354']
2588,32663640,"A Commentary on ""Effects of Edaravone on Postoperative Cognitive Function in Elderly Patients undergoing Hip Joint Replacement Surgery: A Randomized Controlled Trial"" (Int J Surg 2020;80:13-18).",,2020,,['Elderly Patients undergoing Hip Joint Replacement Surgery'],['Edaravone'],['Postoperative Cognitive Function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Woo', 'Affiliation': 'School of Medicine, Cardiff University, University Hospital of Wales, Heath Park, Cardiff, CF14 4XN, United Kingdom. Electronic address: WooTK@Cardiff.ac.uk.'}, {'ForeName': 'Sashiananthan', 'Initials': 'S', 'LastName': 'Ganesananthan', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, United Kingdom.'}, {'ForeName': 'ChunHei', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, United Kingdom.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.001']
2589,32663660,"Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.","BACKGROUND


Current guidelines recommend anticoagulation therapy during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, whether anticoagulation should be continued after pPCI has not been well investigated.
METHODS/DESIGN


The RIGHT trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure. Patients are randomized in a 1:1 fashion to receive either prolonged anticoagulant or matching placebo (no anticoagulation) for at least 48 hours after the procedure. When randomized to anticoagulation prolongation, the patient is assigned to intravenous unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin (same drug and same regimen at each center). The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The primary safety endpoint is major bleeding (BARC 3-5) at 30 days. Based on a superiority design and assuming a 35% relative risk reduction (from 7% to 4.5%), 2856 patients will be enrolled, accounting for a 5% drop-out rate (α = 0.05 and power = 80%).
CONCLUSION


The RIGHT trial tests the hypothesis that post-procedural anticoagulation is superior to no anticoagulation in reducing ischemic events in STEMI patients undergoing pPCI.",2020,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","['STEMI patients undergoing pPCI', 'STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure', 'after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction']","['prolonged anticoagulant or matching placebo (no anticoagulation', 'unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin', 'anticoagulation prolongation versus no anticoagulation', 'placebo']","['composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel', 'major bleeding (BARC 3-5', 'ischemic events']","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",2856.0,0.600901,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: eva3321@sina.com.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spaceeye123@126.com.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Beijing Luhe Hospital, Capital Medical University, Beijing, China. Electronic address: guojcmd@126.com.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Hospital of Hebei Medical University, Shijiazhuang, China. Electronic address: lyjbs2009@yeah.net.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ai', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: aihui0814@126.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: tjmusky@126.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Que', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: quebin@sohu.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhen', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: 13439546840@yeah.net.'}, {'ForeName': 'Jiapeng', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: jiapeng.lu@fwoxford.org.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: chshma@vip.sina.com.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Nie', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spnie@ccmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.06.005']
2590,32663945,Placebo prevents rumination: An experimental study.,"BACKGROUND


Rumination is a risk factor for the development and maintenance of depressive symptoms and represents an important target for the treatment of depression. In the present study, we aimed to examine whether rumination can be reduced when participants are led to believe that they would receive medication that would prevent them from ruminating.
METHODS


In healthy participants (N= 91), an initial dysphoric state was induced via mood-suggestive music and autobiographic recall. Subsequently, participants were randomly assigned to one of two groups: an experimental group that received a deceptive active placebo via intranasal application accompanied by expectancy-enhancing instructions vs. a no-treatment control group. Then, rumination was induced via a rumination-activating task. The primary outcome was current rumination; experienced sadness was considered a secondary outcome.
RESULTS


Consistent with the hypothesis, participants receiving the placebo reported a significantly lower increase in current rumination (d= 0.57) and a higher decrease in sadness (d= 0.69) after the experimental induction than the control group.
LIMITATIONS


The external validity of this study might be limited due to the highly educated student sample.
CONCLUSIONS


The results suggest that rumination processes as well as experienced sadness can be positively influenced by placebo treatment. To evaluate its clinical potential, placebo-induced expectancy effects in rumination research should be further examined, particularly with clinically depressed patients. Also, the results imply that clinicians might consider the effects of expectations on patients' rumination tendencies, for example by explicitly addressing patients' expectations about rumination, mood, and the treatment in general.",2020,"Consistent with the hypothesis, participants receiving the placebo reported a significantly lower increase in current rumination (d= 0.57) and a higher decrease in sadness (d= 0.69) after the experimental induction than the control group.
","['healthy participants (N=\xa091), an initial dysphoric state was induced via mood-suggestive music and autobiographic recall']","['Placebo', 'deceptive active placebo via intranasal application accompanied by expectancy-enhancing instructions vs. a no-treatment control group', 'placebo']","['current rumination; experienced sadness', 'current rumination', 'rumination', 'sadness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}]",,0.185686,"Consistent with the hypothesis, participants receiving the placebo reported a significantly lower increase in current rumination (d= 0.57) and a higher decrease in sadness (d= 0.69) after the experimental induction than the control group.
","[{'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Rebstock', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany. Electronic address: lea.rebstock@uni-marburg.de.'}, {'ForeName': 'Leonora N', 'Initials': 'LN', 'LastName': 'Schäfer', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kube', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany; Department for Clinical Psychology and Psychotherapy, University of Koblenz-Landau, Ostbahnstraße 10, 76829 Landau, Germany.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Ehmke', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.010']
2591,32663974,A randomized controlled trial of a standard 4-week protocol of repetitive transcranial magnetic stimulation in severe treatment resistant depression.,"BACKGROUND


Treatment options for major depressive disorder (MDD) in individuals who are depressed for at least 2 years and failed two or more different types of therapeutic intervention, remain scarce. Being less invasive than electroconvulsive therapy, repetitive transcranial magnetic stimulation (rTMS) might be an alternative treatment option.
RESEARCH QUESTION


Does high frequency rTMS applied over the left prefrontal cortex ameliorate depressive symptoms in patients with treatment resistant major depressive disorder and is the efficacy dependent on treatment resistance?
METHOD


We performed a randomized controlled trial investigating the effect of twenty sessions of real or sham-rTMS, during 4 consecutive weeks. Efficacy was blindly rated with the Hamilton depression rating scale (HDRS-17) at baseline and 1 week after end of treatment, and the Dutch method for quantification of treatment resistance in Depression (DM-TRD) was assessed at baseline.
RESULTS


An interim analysis showed no differences in antidepressant response between real and sham rTMS and we therefore discontinued the RCT after 31 patients. The mean difference of the HDRS score between baseline and post-treatment was 3.7 (± 4.0; change 16%), indicating a small but significant improvement across time (F(1,30)=25.4;p < 0.01). There were no differences however between the treatment arms (F(1.30) = 1.5;p = 0.23). We did find a negative correlation between the change in HDRS score and DM-TRD in the active rTMS group, but this correlation was not significantly different from the sham group.
CONCLUSION


""Standard"" 4-week rTMS treatment is not effective in chronic, severe treatment-resistant depressed patients. While a replication of our data in this patient group may be ethically difficult, further research with less treatment resistant patients might help in positioning rTMS within the current stepped care approach to depression.",2020,An interim analysis showed no differences in antidepressant response between real and sham rTMS and we therefore discontinued the RCT after 31 patients.,"['severe treatment resistant depression', 'major depressive disorder (MDD) in individuals who are depressed for at least 2 years and failed two or more different types of therapeutic intervention, remain scarce', 'patients with treatment resistant major depressive disorder']","['electroconvulsive therapy, repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'real or sham-rTMS']","['HDRS score and DM-TRD', 'Hamilton depression rating scale (HDRS-17', 'Depression (DM-TRD', 'antidepressant response', 'HDRS score']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]",,0.0985111,An interim analysis showed no differences in antidepressant response between real and sham rTMS and we therefore discontinued the RCT after 31 patients.,"[{'ForeName': 'P F P', 'Initials': 'PFP', 'LastName': 'van Eijndhoven', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: Philip.vanEijndhoven@radboudumc.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bartholomeus', 'Affiliation': 'Rijnstate Hospital Arnhem, Department of Psychiatry, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Möbius', 'Affiliation': 'Behavioral Science Institute, Department of Clinical Psychology, Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Bruijn', 'Affiliation': 'Depression Expertise Centre, Pro Persona Mental Health Care, Reinier Postlaan 6, 6525 GC Nijmegen,The Netherlands.'}, {'ForeName': 'G R A', 'Initials': 'GRA', 'LastName': 'Ferrari', 'Affiliation': 'Behavioral Science Institute, Department of Clinical Psychology, Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mulders', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Schene', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'D J L G', 'Initials': 'DJLG', 'LastName': 'Schutter', 'Affiliation': 'Department of Experimental Psychology, Helmholtz Institute, Utrecht University, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spijker', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands; Depression Expertise Centre, Pro Persona Mental Health Care, Reinier Postlaan 6, 6525 GC Nijmegen,The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tendolkar', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.055']
2592,32663977,Combined treatment with escitalopram and memantine increases gray matter volume and cortical thickness compared to escitalopram and placebo in a pilot study of geriatric depression.,"BACKGROUND


Geriatric depression with subjective cognitive complaints increases the risk of Alzheimer's Disease (AD). Memantine is a cognitive enhancer used to treat AD. In a 6-month double-blind randomized placebo-controlled trial of escitalopram and memantine (ESC/MEM), ESC/MEM improved cognition at 12 month in geriatric depression (NCT01902004). We now investigated structural neuroplastic changes at 3 months.
METHODS


Forty-one older depressed adults (mean age=70.43, SD=7.33, 26 female) were randomized to receive ESC/MEM or ESC/PBO. Mood scores (Hamilton Depression Rating Scale, HAMD) and high-resolution structural T1-weighted images were acquired at baseline and 3 months. Freesurfer 6.0 for image processing and General Linear Models was used to examine group differences in symmetrized percent change gray matter volume (GMV) and cortical thickness, controlling for age and intracranial volume. Nonparametric tests were used to investigate group differences in mood and subcortical volume change.
RESULTS


Among 27 completers (ESC/MEM n = 13; ESC/PBO n = 14), 62% achieved remission (HAMD≤6) with ESC/MEM and 43% with ESC/PBO (Fisher's exact p=.45). Change in HAMD did not differ between groups (F(1,23)=0.14, p=.7). GMV and thickness increased more with ESC/MEM than with ESC/PBO in the left middle and inferior temporal lobe, right medial, and lateral orbito-frontal cortex (OFC).
LIMITATIONS


included small sample size, dropout, and the lack of cognitive data at 3 months.
CONCLUSIONS


Although significant group differences in mood improvement were not observed, ESC/MEM resulted in increased GMV and cortical thickness in several brain regions compared to placebo. Larger longitudinal clinical trials can further examine the neuroprotective effect of memantine in geriatric depression.",2020,"Although significant group differences in mood improvement were not observed, ESC/MEM resulted in increased GMV and cortical thickness in several brain regions compared to placebo.","['geriatric depression', 'Forty-one older depressed adults (mean age=70.43, SD=7.33, 26 female']","['escitalopram and memantine (ESC/MEM), ESC/MEM', 'ESC/MEM or ESC/PBO', 'memantine', 'Memantine', 'escitalopram and placebo', 'escitalopram and memantine', 'placebo']","['GMV and thickness', 'left middle and inferior temporal lobe, right medial, and lateral orbito-frontal cortex (OFC', 'Change in HAMD', 'Mood scores (Hamilton Depression Rating Scale, HAMD) and high-resolution structural T1-weighted images', 'mood improvement', 'gray matter volume (GMV) and cortical thickness, controlling for age and intracranial volume', 'mood and subcortical volume change', 'GMV and cortical thickness', 'gray matter volume and cortical thickness']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",41.0,0.0984536,"Although significant group differences in mood improvement were not observed, ESC/MEM resulted in increased GMV and cortical thickness in several brain regions compared to placebo.","[{'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Krause-Sorio', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: bkrause@ucla.edu.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Siddarth', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: PSiddarth@mednet.ucla.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kilpatrick', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: lakilpatrick@mednet.ucla.edu.'}, {'ForeName': 'Kelsey T', 'Initials': 'KT', 'LastName': 'Laird', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Michaela M', 'Initials': 'MM', 'LastName': 'Milillo', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ercoli', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: LErcoli@mednet.ucla.edu.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Narr', 'Affiliation': 'Department of Neurology, 635 Charles E. Young Drive South, Los Angeles, CA 90095, USA. Electronic address: knarr@ucla.edu.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: hlavretsky@mednet.ucla.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.092']
2593,32663980,Plasma Circular RNA DYM Related to Major Depressive Disorder and Rapid Antidepressant Effect Treated by Visual Cortical Repetitive Transcranial Magnetic Stimulation.,"BACKGROUND


Reduced plasma circular RNA DYM (circDYM) has been detected in patients with major depressive disorder (MDD). Mechanism research has demonstrated that circDYM, acting as a microRNA-9 sponge, suppressed microglial activation by increasing Heat Shock Protein 90 ubiquitination, indicating that circDYM could be a potential biomarker of MDD.
METHODS


Thirty-two normal controls (NCs) and 60 MDD patients were recruited. Enrolled patients were randomly allocated to the real or sham repetitive transcranial magnetic stimulation (rTMS) group, followed by continuous five-day visual cortical rTMS or sham treatment. All participants underwent multidimensional neuropsychological assessments and detection of circDYM levels.
RESULTS


Initial scores on all emotional and psychosocial assessments in MDD were significantly different from those of NCs. As compared with the NC group, baseline plasma circDYM levels in MDD patients decreased remarkably (p=0.030) and showed significant positive correlations with the scores of the 24-item Hamilton Depression Rating Scale (r=0.318, p=0.031) and retardation subscale (r=0.323, p=0.029). The increase in circDYM was noteworthy after rTMS (p=0.006), while downregulation with no statistical significance was observed after sham treatment (p=0.170).
LIMITATIONS


It was not estimated on the correlation between plasma circDYM levels and long-term efficacy of rTMS. The mechanism of upregulated circDYM expression in response to visual cortical rTMS remained unrevealed, and the sample size was relatively small.
CONCLUSIONS


This study verified the reduced circDYM levels in MDD patients, and further determined the upregulated circDYM expression after rTMS treatment, revealing the potential of circDYM as a biomarker for MDD diagnosis and antidepressant effect of visual cortical rTMS.",2020,"The increase in circDYM was noteworthy after rTMS (p=0.006), while downregulation with no statistical significance was observed after sham treatment (p=0.170).
","['Thirty-two normal controls (NCs) and 60 MDD patients were recruited', 'patients with major depressive disorder (MDD', 'MDD patients']","['Visual Cortical Repetitive Transcranial Magnetic Stimulation', 'real or sham repetitive transcranial magnetic stimulation (rTMS) group, followed by continuous five-day visual cortical rTMS or sham treatment']","['emotional and psychosocial assessments in MDD', '24-item Hamilton Depression Rating Scale', 'retardation subscale', 'baseline plasma circDYM levels', 'plasma circDYM levels', 'increase in circDYM']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",32.0,0.0328053,"The increase in circDYM was noteworthy after rTMS (p=0.006), while downregulation with no statistical significance was observed after sham treatment (p=0.170).
","[{'ForeName': 'Ruize', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Affiliated ZhongDa Hospital, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Pharmacology, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China.'}, {'ForeName': 'Xianrui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China; Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Yachen', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Affiliated ZhongDa Hospital, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Bi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Haisan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Affiliated ZhongDa Hospital, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China; Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China. Electronic address: janemengzhang@vip.163.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.109']
2594,32664047,"Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.",,2014,,['patients receiving high-dose'],"['cisplatin', 'single-dose fosaprepitant', 'placebo']","['nausea and vomiting', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.638118,,[],Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt534']
2595,32664052,Study protocol for the Fex-Can Childhood project: An observational study and a randomized controlled trial focusing on sexual dysfunction and fertility-related distress in young adult survivors of childhood cancer.,"BACKGROUND


This study protocol describes the Fex-Can Childhood project, comprising two studies: The Fex-Can Childhood observational study (OS) and the Fex-Can Childhood randomized controlled trial (RCT). The Fex-Can Childhood OS aims to determine the prevalence and predictors of sexual dysfunction and fertility-related distress in young adult childhood cancer survivors (aged 19-40) compared to an age matched comparison group; the Fex-Can Childhood RCT will evaluate the effect of a web-based psycho-educational intervention (Fex-Can intervention) on sexual dysfunction and fertility-related distress.
METHODS


The Fex-Can Childhood OS will have a population-based cross-sectional design. All individuals treated for childhood cancer in Sweden at the age of 0 to 17 years (current age 19-40) will be identified through the National Quality Registry for Childhood Cancer. Established self-reported instruments will be used to measure sexual function, fertility-related distress, body image, anxiety and depression, and health-related quality of life. Self-efficacy related to sexual function and fertility, and fertility-related knowledge, will be assessed by study-specific measures. Clinical variables will be collected from the registry. Results will be compared to an age-matched comparison group from the general population.Participants in the Fex-Can Childhood OS who report a high level of sexual dysfunction and/or fertility-related distress will be invited to participate in the RCT. The Fex-Can intervention comprises two programs: The Fex-Can Sex and the Fex-Can Fertility targeting sexual dysfunction and fertility-related distress, respectively. The control condition will be a wait-list. Sexual function and fertility-related distress will be the primary outcomes. The secondary outcomes include body image, anxiety and depression, health-related quality of life and self-efficacy related to sexual function and fertility. Post- and follow-up assessments will be conducted directly after end of intervention (primary end point), at 3 months and 6 months after end of intervention. Additionally, a process-evaluation including study-specific items and a qualitative interview will be conducted.
DISCUSSION


The Fex-Can Childhood project will advance knowledge in the areas of sexual function and fertility-related distress among young adult survivors of childhood cancer. If the Fex-Can intervention proves to be efficacious, steps will be taken to implement it in the follow-up care provided to this population.",2020,The Fex-Can Childhood project will advance knowledge in the areas of sexual function and fertility-related distress among young adult survivors of childhood cancer.,"['Participants in the Fex-Can Childhood OS who report a high level of sexual dysfunction and/or fertility-related distress', 'young adult survivors of childhood cancer', 'All individuals treated for childhood cancer in Sweden at the age of 0 to 17 years (current age 19-40', 'young adult childhood cancer survivors (aged 19-40']","['web-based psycho-educational intervention (Fex-Can intervention', 'Fex-Can Childhood RCT']","['Fex', 'Sexual function and fertility-related distress', 'body image, anxiety and depression, health-related quality of life and self-efficacy related to sexual function and fertility', 'sexual dysfunction and fertility-related distress', 'sexual function, fertility-related distress, body image, anxiety and depression, and health-related quality of life']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0301707,The Fex-Can Childhood project will advance knowledge in the areas of sexual function and fertility-related distress among young adult survivors of childhood cancer.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ljungman', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Poorna', 'Initials': 'P', 'LastName': 'Anandavadivelan', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Jahnukainen', 'Affiliation': ""Division of Haematology-Oncology and Stem Cell Transplantation, Children's Hospital, University of Helsinki, Helsinki University Central Hospital, Helsinki, Finland.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lampic', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Wettergren', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",Medicine,['10.1097/MD.0000000000019919']
2596,32664057,Efficacy of high-dissolution turmeric-sesame formulation for pain relief in adult subjects with acute musculoskeletal pain compared to acetaminophen: A randomized controlled study.,"BACKGROUND


Acetaminophen (paracetamol) is one of the most commonly used over-the-counter for pain relief. Management of acute pain with plant-based nutrients has remained suboptimal due to an absence of data supporting acute relief of pain. In the present study, it was hypothesized that high-dissolution liquid treatment of black sesame extract oil, Curcuma longa and Boswellia serrata may provide pain relief in people with acute musculoskeletal pain as quickly as acetaminophen.
METHODS


In this randomized active controlled open label study, 88 healthy subjects with acute musculoskeletal pain were randomized to receive treatment capsule (Rhuleave-K; 1,000 mg/d) or 1,000 mg/d acetaminophen for 7 days. Change in pain intensity and pain relief at first 6 hours, 3 days, and 7 days were measured. The onset of analgesia was measured by perceptible pain relief and meaningful pain relief. Other measures were McGill Pain Questionnaire and Patient Global Impression Change.
RESULTS


The treatment formulation resulted in average magnitude of pain relief comparable to the acetaminophen. Sixty-six percent of subjects in the treatment group reported positive response in pain relief (≥50% max TOTPAR; total pain relief) after 6 hours, compared to 73% of control. Seventy-three percent of subjects on treatment were considered positive responders, compared to 80% in the control group. The average time of onset of analgesia was 1 hour for the treatment group, versus 0.83 hour for control. At the end of day 3 and 7, there was significant improvement (P < .001 for day 3 and day 7) in the pain condition of treatment group and was comparable to control (P = .436 for day 3 and P = .529 for day 7). The total McGill Pain score showed significant reduction in pain with the treatment irrespective of the pain intensity statistically equal (P = .468) to control. Both the groups were equal in providing sensory pain relief (P = .942), but the treatment was 8.57 times significantly better (P = .027) than acetaminophen in reducing the unpleasantness and emotional aspects (affective domain) involved with acute pain.
CONCLUSION


The results showed that the treatment used in the study may act as a natural, fast acting, and safe alternative for acute pain relief comparable to acetaminophen.",2020,"At the end of day 3 and 7, there was significant improvement (P < .001 for day 3 and day 7) in the pain condition of treatment group and was comparable to control (P = .436 for day 3 and P = .529 for day 7).","['adult subjects with acute musculoskeletal pain', '88 healthy subjects with acute musculoskeletal pain', 'people with acute musculoskeletal pain']","['treatment capsule (Rhuleave-K; 1,000\u200amg/d) or 1,000\u200amg/d acetaminophen', 'Acetaminophen (paracetamol', 'acetaminophen', 'high-dissolution turmeric-sesame formulation']","['positive response in pain relief', 'pain relief', 'McGill Pain Questionnaire and Patient Global Impression Change', 'pain intensity and pain relief', 'average time of onset of analgesia', 'unpleasantness and emotional aspects (affective domain', 'perceptible pain relief and meaningful pain relief', 'total McGill Pain score', 'sensory pain relief', 'pain condition', 'pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}, {'cui': 'C1123051', 'cui_str': 'Sesame'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0243152', 'cui_str': 'emotional aspects'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",88.0,0.0812624,"At the end of day 3 and 7, there was significant improvement (P < .001 for day 3 and day 7) in the pain condition of treatment group and was comparable to control (P = .436 for day 3 and P = .529 for day 7).","[{'ForeName': 'Girish H', 'Initials': 'GH', 'LastName': 'Rudrappa', 'Affiliation': 'Department of Orthopedics, Sapthagiri Institute of Medical Sciences and Research Center, Bangalore, Karnataka.'}, {'ForeName': 'Pruthvi T', 'Initials': 'PT', 'LastName': 'Chakravarthi', 'Affiliation': 'Department of Orthopedics, Sapthagiri Institute of Medical Sciences and Research Center, Bangalore, Karnataka.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar, Thrissur, Kerala, India.'}]",Medicine,['10.1097/MD.0000000000020373']
2597,32664064,"Safety and efficacy of an herbal formula, Gwakhyangjeonggi-san on atopic dermatitis with gastrointestinal symptoms: Protocol for a randomized controlled trial.","INTRODUCTION


Gwakhyangjeonggi-san (GJS) is an herbal formula with anti-inflammatory and anti-allergic properties that is broadly used to treat a wide range of diseases including gastrointestinal disorders and allergic diseases. There have been several clinical studies conducted on its effects on atopic dermatitis (AD). So far, no randomized controlled trials have been conducted. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GJS for treating patients with AD that have gastrointestinal symptoms.
METHODS AND ANALYSIS


A randomized, double-blind, placebo-controlled, parallel-group, clinical trial has been designed to investigate the clinical efficacy and safety of GJS on patients with AD that have gastrointestinal symptoms. A total of 58 participants with AD will be recruited and randomly allocated to the GJS or placebo group in a 1:1 ratio. The participants will be administered GJS or placebo granules 3 times a day for 8 weeks. Data will be collected from the participants at baseline and after 4 and 8 weeks. The primary outcome measure will be the mean change in the SCORing of Atopic Dermatitis (SCORAD) index from baseline to 8 weeks. The secondary outcomes will include the eczema area and severity index (EASI), dermatology life quality index (DLQI), EuroQoL 5 dimensions 5 levels (EQ-5D-5L), and immunological factors. The Korean Gastrointestinal Symptom Rating Scale (KGSRS), Nepean Dyspepsia Index will also be obtained for assessing the gastrointestinal status.
DISCUSSION


The findings of this study are expected to provide evidence on the safety and effectiveness of GJS and for treating patients with AD that have gastrointestinal symptoms. Additionally, the study will explore the mechanism of GJS action via gut microbiome. This study will provide new perspectives on approaching treatment for AD.
ETHICS AND DISSEMINATION


The study protocol was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital at Gangdong (KHNMCOH2019-06-002-001).
TRIAL REGISTRATION NUMBER


This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004299).",2020,The primary outcome measure will be the mean change in the SCORing of Atopic Dermatitis (SCORAD) index from baseline to 8 weeks.,"['Kyung Hee University Korean Medicine Hospital at Gangdong (KHNMCOH2019-06-002-001', '58 participants with AD', 'patients with AD that have gastrointestinal symptoms', 'atopic dermatitis with gastrointestinal symptoms']","['Gwakhyangjeonggi-san', 'herbal formula', 'Gwakhyangjeonggi-san (GJS', 'GJS or placebo', 'GJS', 'placebo']","['Korean Gastrointestinal Symptom Rating Scale (KGSRS', 'eczema area and severity index (EASI), dermatology life quality index (DLQI), EuroQoL 5 dimensions 5 levels (EQ-5D-5L), and immunological factors', 'efficacy and safety', 'Safety and efficacy', 'mean change in the SCORing of Atopic Dermatitis (SCORAD) index']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C3850537', 'cui_str': 'gwakhyangjeonggi-san'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0021054', 'cui_str': 'Immunologic substance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",58.0,0.607587,The primary outcome measure will be the mean change in the SCORing of Atopic Dermatitis (SCORAD) index from baseline to 8 weeks.,"[{'ForeName': 'Mi Ju', 'Initials': 'MJ', 'LastName': 'Son', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon.'}, {'ForeName': 'Min Hee', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul.'}, {'ForeName': 'Minseo', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Kim', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jeeyoun', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon.'}, {'ForeName': 'Inhwa', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul.'}]",Medicine,['10.1097/MD.0000000000020675']
2598,32664066,Prospective study to optimize the health of patients with TIAS (transient ischemic attack) and stroke admitted to the Hamad General Hospital.,"INTRODUCTION


Recurrent ischemic strokes (IS) make up to one-third of all strokes. Nine out of 10 strokes are due to modifiable risk factors. Thus, it seems that standard management strategies of modifiable risk factors are yet to improve. Hence, we planned a randomized controlled trial assessing nurses or pharmacists-led aggressive control of comorbidities and their prognostic impact on IS and transient ischemic attacks (TIA).
METHODS/DESIGN


Prospective study to optimize the health of patients with TIAs and stroke admitted to the Hamad General Hospital (PROMOTE HEALTH) is an assessor-blinded, open-label, randomized, two-arm, controlled trial. Eligible patients have IS or TIA, and an additional modifiable risk factor (Hypertension or dyslipidemia) attending the stroke ward or clinic at the Weill Cornell-affiliated Hamad General Hospital. Stroke specialists will offer the control group the currently practiced best risk factor management strategies. Whereas, in the intervention arm, with the assistance of a nurse and a pharmacist, we will make aggressive attempts to meet targets of defined risk factors. The primary outcomes are the mean difference in blood pressure (BP) and low-density lipoprotein. Whereas myocardial infarction, recurrent stroke events, and mortality serve as the study's secondary outcomes. We require 200 patients per study arm to achieve a power of 80% and an alpha level of <0.05. The Medical Research Center and the Institutional Review Board have approved the study, and it was prospectively registered in a trial registry.
DISCUSSION


A significant proportion of strokes are due to modifiable preventable risk factors. Despite having the right preventive strategies aimed at mitigating these risk factors, a sizeable proportion of strokes are due to recurring events. This prompted the medical community to evaluate aggressive means of addressing these risk factors. The nurse or pharmacist-led management of comorbidities has been proven to be of value in the management of diabetes and hypertension. It will be of value to demonstrate the effectiveness of utilizing this additional task force in aggressively managing IS or TIA patients with an overarching goal of improving their prognosis. If our intervention proves to be efficacious, this would have a substantial impact on the current stroke practices and guidelines. Additionally, it will invite further research in the area.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov NCT02868723, last updated on September 2018.",2020,The nurse or pharmacist-led management of comorbidities has been proven to be of value in the management of diabetes and hypertension.,"['patients with TIAs and stroke admitted to the Hamad General Hospital (PROMOTE HEALTH', 'Eligible patients have IS or TIA, and an additional modifiable risk factor (Hypertension or dyslipidemia) attending the stroke ward or clinic at the Weill Cornell-affiliated Hamad General Hospital', 'patients with TIAS (transient ischemic attack) and stroke admitted to the Hamad General Hospital']",[],"['mean difference in blood pressure (BP) and low-density lipoprotein', 'myocardial infarction, recurrent stroke events, and mortality serve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0678786,The nurse or pharmacist-led management of comorbidities has been proven to be of value in the management of diabetes and hypertension.,"[{'ForeName': 'Yahia Z', 'Initials': 'YZ', 'LastName': 'Imam', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Mouhand F H', 'Initials': 'MFH', 'LastName': 'Mohamed', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital, Hamad Medical Corporation.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdelmoneim', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Alkhawad', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Numan', 'Initials': 'N', 'LastName': 'Amir', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Saqqur', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Muhammad', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elsoutohy', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Saadat', 'Initials': 'S', 'LastName': 'Kamran', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Akhtar', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Abdul Salim', 'Initials': 'AS', 'LastName': 'Kiliyanni', 'Affiliation': 'Radiology Department, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Own', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Deleu', 'Affiliation': 'Neuroscience Institute, Hamad Medical Corporation.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Alberta, Edmonton, Canada.'}]",Medicine,['10.1097/MD.0000000000020694']
2599,32664070,Femoral nerve block vs adductor canal block after anterior cruciate ligament reconstruction under general anesthesia: A prospective randomized trial protocol.,"BACKGROUND


Femoral nerve block (FNB) is considered the preferred analgesia after anterior cruciate ligament reconstruction (ACLR), but leads to weakness in the quadriceps muscles. Adductor canal block (ACB) is a new sensory block technique that effectively relieves postoperative pain while preserving quadriceps strength. The purpose of our study was to compare the efficacy of FNB vs ACB for pain control after ACLR.
METHODS


This prospective, randomized, double-blind, controlled, superiority clinical trial was approved by the institutional review board in our university hospital. We enrolled 120 patients set to undergo ACLR in this randomized therapeutic trial. Sixty patients received FNB and the other 60 received ACB for postoperative pain control. All ACB and FNB were performed using ultrasound-guided single-shot procedures. The primary outcomes included maximum voluntary isovolumetric contraction and postoperative pain score. Secondary outcomes included total opioid consumption, length of hospital stay, complication, and satisfaction score.
RESULTS


This clinical trial might provide some insights to estimate and compare the safety and efficacy of ACB vs FNB following ACLR.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5569).",2020,"Secondary outcomes included total opioid consumption, length of hospital stay, complication, and satisfaction score.
","['anterior cruciate ligament reconstruction under general anesthesia', '120 patients set to undergo ACLR', 'anterior cruciate ligament reconstruction (ACLR']","['Femoral nerve block vs adductor canal block', 'Femoral nerve block (FNB', 'ACB', 'Adductor canal block (ACB', 'FNB vs ACB', 'FNB']","['postoperative pain control', 'total opioid consumption, length of hospital stay, complication, and satisfaction score', 'maximum voluntary isovolumetric contraction and postoperative pain score']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",120.0,0.34174,"Secondary outcomes included total opioid consumption, length of hospital stay, complication, and satisfaction score.
","[{'ForeName': 'Qingpei', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Orthopedics. Qingdao Huangdao Central Hospital.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Orthopedics. Laixi People's Hospital.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics. Qingdao Huangdao People's Hospital, Shandong, China.""}, {'ForeName': 'Jinkui', 'Initials': 'J', 'LastName': 'Sui', 'Affiliation': 'Department of Orthopedics. Qingdao Huangdao Central Hospital.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics. Qingdao Huangdao Central Hospital.'}]",Medicine,['10.1097/MD.0000000000020776']
2600,32662160,The Effects of a Community Animation Program in a Rural Setting on the Participants' Quality of Life.,"BACKGROUND


This study presents the evaluation of a Community Animation Program (CAP) conducted in a rural town in Spain aimed towards improving the participants' Quality of Life. The program includes animation, culture, and leisure activities to improve not only the inhabitants' Subjective Quality of Life but also social cohesion and enhance a sense of community belonging.
METHODS


A repeated measure pre/post-test design with an experimental and equivalent control group (55 participants per group) was used to evaluate the efficacy of the Program. Instruments included measures of Quality and Satisfaction of Life, Happiness, Positive and Negative Affect, Mental Health, Self-esteem, Loneliness and Community Support. The number of participants practically included the whole universe of town members participating in community activities.
RESULTS


The program improved the participants' Quality of Life, with a stronger impact on the relational, community and environmental dimensions as well as psychological wellbeing. Community animation prevents isolation and loneliness and creates social cohesion. Social interactions improve life satisfaction of the participants.
CONCLUSION


The CAP enhances integration, leisure and interaction and generates more positive affect, happiness and social wellbeing. Promoting recreation centres and programs in rural settings may improve inhabitants' health and general wellbeing as well as enhancing social connectedness.",2020,"The program improved the participants' Quality of Life, with a stronger impact on the relational, community and environmental dimensions as well as psychological wellbeing.",['participants practically included the whole universe of town members participating in community activities'],"['Community Animation Program', 'Community Animation Program (CAP']","[""participants' Quality of Life"", 'isolation and loneliness and creates social cohesion', 'Quality and Satisfaction of Life, Happiness, Positive and Negative Affect, Mental Health, Self-esteem, Loneliness and Community Support', 'Subjective Quality of Life but also social cohesion and enhance a sense of community belonging', 'relational, community and environmental dimensions as well as psychological wellbeing', 'CAP enhances integration, leisure and interaction and generates more positive affect, happiness and social wellbeing', 'life satisfaction']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C3696958', 'cui_str': 'Social wellbeing'}]",,0.0282144,"The program improved the participants' Quality of Life, with a stronger impact on the relational, community and environmental dimensions as well as psychological wellbeing.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ubillos-Landa', 'Affiliation': 'University of Burgos, Burgos, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Hortigüela-Arroyo', 'Affiliation': 'Community Development Programmer, Burgos, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'González-Castro', 'Affiliation': 'University of Burgos, Burgos, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Puente-Martinez', 'Affiliation': 'Universidad del País Vasco, avda. Tolosa, Donostia, Spain.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12204']
2601,32662168,An investigation of the effect of the psychoeducation program provided to alexithymic and violent adolescents on the level of alexithymia.,"PROBLEM


Alexithymia is defined as difficulties in defining and describing feelings, differentiating feelings and bodily sensations caused by emotional arousal, and a combination of constricted imaginary processes. This study aims to investigate the effect of the psychoeducation program provided to individuals with alexithymia and violent tendencies adolescents on the level of alexithymia.
METHODS


This experimental study was conducted between February 2019 and April 2019. The sample was 80 volunteer adolescents (experimental group n = 40 and control group n = 40) who met the research criteria. Data were collected using the Sociodemographic Form, the Tendency to Violence Scale, and the Alexithymia Questionnaire for Children (AQC). The psychoeducation program was applied in the experimental group in 90-min sessions once a week throughout 9 weeks.
FINDINGS


There was a statistically significant decrease in the AQC posttest mean scores after the training provided to the experimental group (p < .01).
CONCLUSIONS


The psychoeducation provided to adolescents was found to reduce the level of alexithymia. It is recommended that similar studies should be conducted with larger groups.",2020,"There was a statistically significant decrease in the AQC posttest mean scores after the training provided to the experimental group (p < .01).
","['individuals with alexithymia and violent tendencies adolescents', 'February 2019 and April 2019', '80 volunteer adolescents (experimental group n\u2009=\u200940 and control group n\u2009=\u200940) who met the research criteria']",['psychoeducation program'],"['level of alexithymia', 'AQC posttest mean scores', 'Alexithymia Questionnaire for Children (AQC']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0217007,"There was a statistically significant decrease in the AQC posttest mean scores after the training provided to the experimental group (p < .01).
","[{'ForeName': 'Ayse B', 'Initials': 'AB', 'LastName': 'Bakan', 'Affiliation': 'Department of Nursing, School of Health, Agri Ibrahim Cecen University, Agri, Turkey.'}, {'ForeName': 'Gulpinar', 'Initials': 'G', 'LastName': 'Aslan', 'Affiliation': 'First and Immediate Aid Program, Agri Ibrahim Cecen University Health Services Vocational School, Agrı, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Aka', 'Affiliation': 'Therapy and Rehabilitation Program, Agri Ibrahim Cecen University Health Services Vocational School, Agrı, Turkey.'}]","Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc",['10.1111/jcap.12285']
2602,32662184,Effects of Caregiver Dementia Training in Caregiver-Patient Dyads: A Randomized Controlled Study.,"OBJECTIVES


Caregivers for people with dementia (PWD) have reported needing emotional and social support, improved coping strategies, and better information about the illness and available support services. In this study, we aimed to determine the effectiveness of an Australian multicomponent community-based training program that we adapted and implemented in a non-medical Dutch health care setting.
METHODS AND DESIGN


A randomized controlled trial was performed: 142 dyads of cohabiting caregivers and PwD were randomized to control (care as usual) or intervention (training program) groups and outcomes were compared. Programs lasted 1 week, comprised 14 sessions, and were delivered by specialist staff. We included 16 groups of two to six caregivers. The primary outcome was care-related quality of life (CarerQol-7D) at 3 months. The main secondary outcomes for caregivers were self-rated burden, health and mood symptoms, and for PwD were neuropsychiatric symptoms, quality of life, and agitation.
RESULTS


No significant difference was observed for the primary outcome. However, caregivers experienced fewer role limitations due to physical function (adjusted mean difference, 13.04; 95% confidence interval [95%CI], 3.15-22.93), emotional function (13.52; 95%CI, 3.76-23.28), and pain reduction (9.43; 95%CI, 1.00-17.86). Positive outcomes identified by qualitative analysis included better acceptance and coping and improved knowledge of dementia and available community services and facilities.
CONCLUSION


Quantitative analysis showed that the multicomponent course did not affect care-related quality of life but did have a positive effect on experienced role limitations and pain. Qualitative analysis showed that the course met the needs of participating dyads. This article is protected by copyright. All rights reserved.",2020,"However, caregivers experienced fewer role limitations due to physical function (adjusted mean difference, 13.04; 95% confidence interval [95%CI], 3.15-22.93), emotional function (13.52; 95%CI, 3.76-23.28), and pain reduction (9.43; 95%CI, 1.00-17.86).","['Caregiver-Patient Dyads', 'Caregivers for people with dementia (PWD', '142 dyads of cohabiting caregivers and PwD', '16 groups of two to six caregivers']","['control (care as usual) or intervention (training program', 'Australian multicomponent community-based training program', 'Caregiver Dementia Training']","['emotional function', 'care-related quality of life (CarerQol-7D', 'pain reduction', 'self-rated burden, health and mood symptoms, and for PwD were neuropsychiatric symptoms, quality of life, and agitation', 'acceptance and coping and improved knowledge of dementia and available community services and facilities']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0009482', 'cui_str': 'Community Services'}]",142.0,0.20068,"However, caregivers experienced fewer role limitations due to physical function (adjusted mean difference, 13.04; 95% confidence interval [95%CI], 3.15-22.93), emotional function (13.52; 95%CI, 3.76-23.28), and pain reduction (9.43; 95%CI, 1.00-17.86).","[{'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Birkenhäger-Gillesse', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Hanzeplein 1, GZ, Groningen, the Netherlands.'}, {'ForeName': 'Wilco P', 'Initials': 'WP', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, ZA, Leiden, the Netherlands.'}, {'ForeName': 'Sarah I M', 'Initials': 'SIM', 'LastName': 'Janus', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Hanzeplein 1, GZ, Groningen, the Netherlands.'}, {'ForeName': 'Boudewijn J', 'Initials': 'BJ', 'LastName': 'Kollen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Hanzeplein 1, GZ, Groningen, the Netherlands.'}, {'ForeName': 'Sytse U', 'Initials': 'SU', 'LastName': 'Zuidema', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Hanzeplein 1, GZ, Groningen, the Netherlands.'}]",International journal of geriatric psychiatry,['10.1002/gps.5378']
2603,32662191,Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning.,"Trauma survivors with posttraumatic stress disorder (PTSD) frequently also suffer from difficulties in social functioning that range across emotional, cognitive, and environmental domains. A detailed evaluation of the differential impacts of effective PTSD treatments on social functioning is needed. Men and women (N = 200) with chronic PTSD received 10 weeks of prolonged exposure (PE) or sertraline in a randomized clinical trial and were followed for 24 months. A secondary data analysis examined changes in social functioning with regard to fear of intimacy; receipt of social support; and distress, avoidance, and negative cognitions in social situations. Effects were examined between treatments over time, controlling for baseline functioning. There were large, durable improvements across all indices. Compared to sertraline, PE was more efficient at reducing fear of intimacy and distress from negative social cognitions by posttreatment, ds = 0.94-1.14. Patients who received sertraline continued to improve over the course of follow-up, ds = 0.54-1.17. The differential speed of therapeutic effects may argue for more direct mechanisms in cognitive behavioral interventions versus cascade effects in serotonin reuptake inhibitors. Notably, both treatments produced substantial social benefits for trauma survivors with social functioning difficulties, and effect sizes were comparable to typical reductions in PTSD, depression, and anxiety.",2020,"Compared to sertraline, PE was more efficient at reducing fear of intimacy and distress from negative social cognitions by posttreatment, ds = 0.94-1.14.","['Posttraumatic Stress Disorder', 'Men and women (N = 200) with chronic PTSD received 10 weeks of', 'Trauma survivors with posttraumatic stress disorder (PTSD']","['sertraline', 'prolonged exposure (PE) or sertraline', 'Prolonged Exposure and Sertraline', 'sertraline, PE']","['distress, avoidance, and negative cognitions in social situations', 'substantial social benefits', 'fear of intimacy and distress from negative social cognitions', 'PTSD, depression, and anxiety']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",200.0,0.0201058,"Compared to sertraline, PE was more efficient at reducing fear of intimacy and distress from negative social cognitions by posttreatment, ds = 0.94-1.14.","[{'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Graham', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Natalia M', 'Initials': 'NM', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Bergman', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}]",Journal of traumatic stress,['10.1002/jts.22570']
2604,32662200,Comparison of the Effectiveness of Simple Carbohydrates on Hypoglycemic Episodes in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Study in a Diabetes Camp.,"BACKGROUND


Hypoglycemia is the most common and severe complication of insulin treatment during the management of type 1 diabetes mellitus (T1DM). Despite its importance, there is a lack of data about the efficacy and superiority of the carbohydrate sources used in hypoglycemia management in children and adolescents.
OBJECTIVE


We aimed to compare the effectiveness of honey, fruit juice and sugar cubes as simple carbohydrates used in the primary treatment of hypoglycemia in children and adolescents with T1DM, who attended a diabetes summer camp.
METHODS


A prospective randomized study was performed in a five-days-long diabetes summer camp. Three different types of simple carbohydrates; sugar cubes, honey, or fruit juice were randomly given for the treatment of hypoglycemia and the recovery results in the three groups were compared.
RESULTS


Thirty-two patients (53.1% male, mean age 12.9±1.9 years) were included and 158 mild hypoglycemic episodes were observed. Sugar cubes, honey and fruit juice were given in 46 (29.1%), 60 (37.9%) and 52 (33%) events, respectively. We found that honey and fruit juice had similar efficiency in recovering hypoglycemia in 15 minutes with a rate of 95% and 98%, respectively. However, sugar cubes had a significantly lower impact on treatment of hypoglycemia than the others, with a recovery rate of 84.7% at 15 minutes.
CONCLUSIONS


This study showed, for the first time, that honey and fruit juice were more effective in treating hypoglycemia than sugar cubes, and can be preferred in treating hypoglycemic events in children and adolescents with T1DM. This article is protected by copyright. All rights reserved.",2020,"However, sugar cubes had a significantly lower impact on treatment of hypoglycemia than the others, with a recovery rate of 84.7% at 15 minutes.
","['children and adolescents with T1DM, who attended a diabetes summer camp', 'Thirty-two patients (53.1% male, mean age 12.9±1.9\u2009years) were included and 158 mild hypoglycemic episodes', 'children and adolescents with T1DM', 'Children and Adolescents with Type 1 Diabetes Mellitus', 'a Diabetes Camp', 'five-days-long diabetes summer camp', 'children and adolescents']","['honey, fruit juice and sugar cubes', 'Simple Carbohydrates']","['recovering hypoglycemia', 'hypoglycemia', 'Hypoglycemic Episodes', 'Sugar cubes, honey and fruit juice', 'recovery rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}]",,0.0307224,"However, sugar cubes had a significantly lower impact on treatment of hypoglycemia than the others, with a recovery rate of 84.7% at 15 minutes.
","[{'ForeName': 'İbrahim Mert', 'Initials': 'İM', 'LastName': 'Erbaş', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Abacı', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Anık', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Şimşek', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Hale Ünver', 'Initials': 'HÜ', 'LastName': 'Tuhan', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Koçyiğit', 'Affiliation': 'Division of Pediatric Endocrinology, Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Melek', 'Initials': 'M', 'LastName': 'Yıldİz', 'Affiliation': ""Division of Pediatric Endocrinology, Dr Behçet Uz Children's Hospital, İzmir, Turkey.""}, {'ForeName': 'Bumin Nuri', 'Initials': 'BN', 'LastName': 'Dündar', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, İzmir Kâtip Çelebi University, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Böber', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'Gönül', 'Initials': 'G', 'LastName': 'Çatlı', 'Affiliation': 'Division of Pediatric Endocrinology, Faculty of Medicine, İzmir Kâtip Çelebi University, Turkey.'}]",Pediatric diabetes,['10.1111/pedi.13077']
2605,32662209,Treatment of chronic wounds with polyurethane sponges impregnated with boric acid particles: A randomised controlled trial.,"The objective of this study was to investigate the effectiveness of the sponge with boric acid particles combined with the negative pressure wound treatment (NPWT) system for chronic wounds with tissue defects. Our study was designed as a prospective randomised study. One hundred patients who were planned to have NPWT due to chronic wounds were included in this study from Orthopaedics and Traumatology and Plastic Surgery clinics. Patients were divided into two groups. In the first group, a new method, boric acid impregnated sponge, combined with the NPWT system, was used, and in the second group, sponge with silver nitrate was used. Besides the wide-broad spectrum antibacterial properties of silver nitrate, the antimicrobial, angiogenetic, and epithelial effects of boric acid were aimed to investigate by macroscopically and histopathologically. Thirty-six patients in the silver nitrate group and 44 patients in the boric acid group completed the study. A decrease in wound size and granulation was observed in both groups. Macroscopically, a decrease in wound size reduction, epithelialization and granulation were more prominent in the first group in which boric acid impregnated sponge was used than the second group in which silver sponge was used. Moreover, microscopically, the number of fibroblasts, collagen synthesis, and angiogenesis were significantly increased in Group 1. In this clinical study, the broad-spectrum antimicrobial properties of boric acid and its positive effect on the cells responsible for wound healing were found to be more pronounced compared to silver nitrate sponges. A combination of boric acid sponges with the NPWT system may be an alternative method for chronic wounds.",2020,"Macroscopically, a decrease in wound size reduction, epithelialization and granulation were more prominent in the first group in which boric acid impregnated sponge was used than the second group in which silver sponge was used.","['One hundred patients who were planned to have NPWT due to chronic wounds were included in this study from Orthopaedics and Traumatology and Plastic Surgery clinics', 'Thirty-six patients in the silver nitrate group and 44 patients in the boric acid group completed the study', 'chronic wounds with tissue defects']","['boric acid sponges', 'polyurethane sponges impregnated with boric acid particles', 'sponge with boric acid particles combined with the negative pressure wound treatment (NPWT) system']","['wound size and granulation', 'number of fibroblasts, collagen synthesis, and angiogenesis', 'wound size reduction, epithelialization and granulation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1272654', 'cui_str': 'Wound care management'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0040801', 'cui_str': 'Surgical Traumatology'}, {'cui': 'C3715205', 'cui_str': 'Plastic surgery clinic'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0037129', 'cui_str': 'Silver Nitrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006020', 'cui_str': 'boric acid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0006020', 'cui_str': 'boric acid'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1272654', 'cui_str': 'Wound care management'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}]",100.0,0.0196279,"Macroscopically, a decrease in wound size reduction, epithelialization and granulation were more prominent in the first group in which boric acid impregnated sponge was used than the second group in which silver sponge was used.","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Kapukaya', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, University of Health Sciences Adana City Research and Training Hospital, Adana, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Ciloglu', 'Affiliation': 'Department of Orthopaedic and Traumatology, University of Health Sciences Adana City Research and Training Hospital, Adana, Turkey.'}]",International wound journal,['10.1111/iwj.13463']
2606,32662220,Clinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques-A pilot study.,"OBJECTIVE


The restoration of destroyed maxillary primary incisors is difficult because of the insufficient amount of coronal structure. This pilot study aimed to compare the efficacy of composite posts technique and glass fiber posts technique in restoring destroyed primary incisors.
MATERIALS AND METHODS


Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries were randomly assigned after endodontic treatment into two groups: glass fiber posts (n = 18) and composite resin posts (n = 18). Blinded clinical evaluation was made at 3, 6, 9, and 12 months and Blinded radiographic evaluation was made at 6 and 12 months. The evaluation was according to the FDI criteria. Data were analyzed with Fisher's exact test (α = .05).
RESULT


After 12 months post-treatment, the success rates were 88.2% in glass fiber posts group and 70.6% in composite resin posts group. There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
CONCLUSION


Glass fiber posts technique and Composite posts technique may be used in the restoration of destroyed primary incisors.",2020,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
",['Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries'],"['composite resin posts', 'composite posts technique and glass fiber posts technique', 'glass fiber posts']",['success rates'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0080038', 'cui_str': 'Post Technic'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}]",[],11.0,0.0235983,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
","[{'ForeName': 'Seba', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}, {'ForeName': 'Abdul Wahab', 'Initials': 'AW', 'LastName': 'Nourallah', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}]",Clinical and experimental dental research,['10.1002/cre2.307']
2607,30748125,"Effects of Food and Antacids on Pharmacokinetics and Pharmacodynamics of Lesinurad, a Selective Urate Reabsorption Inhibitor.","Two clinical studies were performed in healthy volunteers to investigate food and antacid effects on lesinurad, a novel selective uric acid reabsorption inhibitor approved for treatment of hyperuricemia associated with gout in combination with xanthine oxidase inhibitors. Study 1 evaluated a high-fat, high-calorie meal or high doses of antacids (3000 mg calcium carbonate or 1600 mg magnesium hydroxide/1600 mg aluminum hydroxide) on the pharmacokinetics (PK) and pharmacodynamics (PD) of 400 mg oral lesinurad. Study 2 evaluated low doses of antacids (1250 mg calcium carbonate or 800 mg magnesium hydroxide/800 mg aluminum hydroxide) on the PK and PD of 400 mg lesinurad. Food did not alter the plasma AUC of lesinurad and only reduced its C max  by 18%. In the fasted conditions, high-dose calcium carbonate reduced the C max  and AUC of lesinurad by 54% and 38%, respectively, whereas high-dose magnesium hydroxide/aluminum hydroxide reduced C max  and AUC by 36% and 31%, respectively. Food enhanced the maximum serum urate (sUA)-lowering effect of lesinurad by approximately 20% despite reducing the C max  of lesinurad. High-dose calcium carbonate decreased the urate-lowering effect approximately 20% in the first 6 hours, whereas high-dose magnesium hydroxide/aluminum hydroxide reduced the effect by 26%. Low-dose calcium carbonate or magnesium hydroxide/aluminum hydroxide in the presence of food did not significantly affect plasma lesinurad C max  and AUC or the sUA lowering and renal handling of uric acid. In summary, study results suggest food did not meaningfully alter lesinurad PK and PD. High doses of antacids reduced lesinurad AUC up to 40% and reduced the lesinurad uric acid-lowering effect.",2019,Food enhanced the maximum serum urate (sUA)-lowering effect of lesinurad by approximately 20% despite reducing the C max  of lesinurad.,['healthy volunteers'],"['calcium carbonate or magnesium hydroxide/aluminum hydroxide', 'magnesium hydroxide/1600\xa0mg aluminum hydroxide', 'antacids', 'antacids (1250\xa0mg calcium carbonate or 800\xa0mg magnesium hydroxide/800\xa0mg aluminum hydroxide', 'high-fat, high-calorie meal or high doses of antacids (3000\xa0mg calcium carbonate or 1600', 'xanthine oxidase inhibitors', 'calcium carbonate', 'magnesium hydroxide/aluminum hydroxide', 'Food and Antacids']","['C max  and AUC', 'plasma lesinurad C max  and AUC or the sUA lowering and renal handling of uric acid', 'lesinurad uric acid-lowering effect', 'C max  and AUC of lesinurad', 'maximum serum urate', 'urate-lowering effect', 'pharmacokinetics (PK) and pharmacodynamics (PD', 'plasma AUC of lesinurad and only reduced its C max', 'lesinurad PK and PD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C2930042', 'cui_str': 'Aluminum hydroxide- and magnesium hydroxide-containing product'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0003138', 'cui_str': 'Antacid'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3886073', 'cui_str': 'lesinurad'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.038972,Food enhanced the maximum serum urate (sUA)-lowering effect of lesinurad by approximately 20% despite reducing the C max  of lesinurad.,"[{'ForeName': 'Zancong', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Ardea Biosciences, Inc., San Diego, CA, USA.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Lee', 'Affiliation': 'Ardea Biosciences, Inc., San Diego, CA, USA.'}, {'ForeName': 'Shakti', 'Initials': 'S', 'LastName': 'Valdez', 'Affiliation': 'Ardea Biosciences, Inc., San Diego, CA, USA.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Ardea Biosciences, Inc., San Diego, CA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Ardea Biosciences, Inc., San Diego, CA, USA.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Flanagan', 'Affiliation': 'AstraZeneca, Macclesfield, U.K.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gillen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.663']
2608,31029558,Low Plasma IL-8 Levels During Chemotherapy Are Predictive of Excellent Long-Term Survival in Metastatic Breast Cancer.,"BACKGROUND


Interleukin (IL)-8 is a proinflammatory cytokine, and high levels of IL-8 are associated with poor prognosis in many malignancies. The objective of this study was to explore the clinical benefit of monitoring plasma IL-8 levels during breast cancer chemotherapy.
PATIENTS AND METHODS


We conducted an exploratory analysis of several circulating proteins, including IL-8, in the plasma. Plasma samples were obtained from 58 metastatic breast cancer patients who took part in a prospective phase 2 first-line bevacizumab chemotherapy trial. Samples were analyzed before therapy, after 6 weeks and 6 months of treatment, and at the final study visit. On the basis of a trajectory analysis of the plasma IL-8 levels, the patients were divided into 3 trajectory groups.
RESULTS


Plasma IL-8, IL-6, IL-18, matrix metalloproteinase (MMP)-2, MMP-9, YKL-40, resistin, and high-mobility group box 1 (HMGB1) concentrations were measured, and the most pronounced predictor of patient survival was IL-8. On the basis of the trajectory analysis of the IL-8 levels, the majority of patients (n = 35, 60%) belonged to trajectory group 1, and these patients had significantly lower IL-8 levels before and during the entire chemotherapy treatment period than did the patients in the other groups. Trajectory group 1 patients had significantly better overall survival compared to patients in trajectory group 2 (n = 17; age-adjusted HR = 2.45; 95% confidence interval, 1.21-5.97; P = .012) and 3 (n = 6; age-adjusted HR = 8.65; 95% confidence interval, 3.16-23.7; P < .001).
CONCLUSION


Low IL-8 levels during chemotherapy treatment might help identify patients with prolonged survival.",2019,"RESULTS


Plasma IL-8, IL-6, IL-18, matrix metalloproteinase (MMP)-2, MMP-9,","['58 metastatic breast cancer patients who took part in a prospective phase 2 first-line bevacizumab chemotherapy trial', 'Metastatic Breast Cancer']",[],"['Plasma IL-8, IL-6, IL-18, matrix metalloproteinase (MMP)-2, MMP-9', 'YKL-40, resistin, and high-mobility group box 1 (HMGB1) concentrations', 'overall survival', 'plasma IL-8 levels', 'IL-8 levels', 'Low Plasma IL-8 Levels']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0528649', 'cui_str': 'CHI3L1 protein, human'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0599712,"RESULTS


Plasma IL-8, IL-6, IL-18, matrix metalloproteinase (MMP)-2, MMP-9,","[{'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Tiainen', 'Affiliation': 'Department of Oncology, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; Department of Oncology, Tampere University Hospital, Tampere, Finland. Electronic address: leena.tiainen@tuni.fi.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hämäläinen', 'Affiliation': 'The Immunopharmacology Research Group, Faculty of Medicine and Health Technology, Tampere University and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Luukkaala', 'Affiliation': 'Research, Development and Innovation Center, Tampere University Hospital and Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Tanner', 'Affiliation': 'Department of Oncology, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; Department of Oncology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Lahdenperä', 'Affiliation': 'Department of Oncology and Radiotherapy and FICAN West Cancer Center, Turku University Central Hospital, Turku, Finland.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Vihinen', 'Affiliation': 'Department of Oncology and Radiotherapy and FICAN West Cancer Center, Turku University Central Hospital, Turku, Finland.'}, {'ForeName': 'Arja', 'Initials': 'A', 'LastName': 'Jukkola', 'Affiliation': 'Department of Oncology, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; Department of Oncology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Peeter', 'Initials': 'P', 'LastName': 'Karihtala', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Moilanen', 'Affiliation': 'The Immunopharmacology Research Group, Faculty of Medicine and Health Technology, Tampere University and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Department of Oncology, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; Department of Oncology, Tampere University Hospital, Tampere, Finland.'}]",Clinical breast cancer,['10.1016/j.clbc.2019.03.006']
2609,31044546,Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community-Acquired Pneumonia Treated With Ceftaroline Fosamil.,"Efficacy of ceftaroline fosamil, the prodrug of the active metabolite ceftaroline, was demonstrated in a phase 3 study of hospitalized Asian patients with Pneumonia Outcomes Research Team (PORT) risk class III-IV community-acquired pneumonia (NCT01371838). The objectives of the current analysis were to expand an existing ceftaroline and ceftaroline fosamil population pharmacokinetic (PK) model with data from this phase 3 study and a phase 1 study (NCT01458743) assessing ceftaroline PK in healthy Chinese volunteers and to evaluate the probability of PK/pharmacodynamic (PK/PD) target attainment (PTA) in Asian patients with community-acquired pneumonia (CAP) treated with ceftaroline fosamil. The ceftaroline plasma concentration-time course was simulated for 5000 Asian patients with CAP for different renal function subgroups using the final model. PTA was calculated for Streptococcus pneumoniae, Staphylococcus aureus, and non-extended-spectrum β-lactamase-producing Enterobacteriaceae. PTA was also evaluated for ceftaroline MIC 90  values of isolates collected from Asia-Pacific surveillance studies (2012-2014) and for EUCAST and FDA/CLSI ceftaroline susceptibility break points. The final model reasonably described the ceftaroline PK. Race was not found to be a significant covariate impacting ceftaroline PK, suggesting similar ceftaroline PK in Asian and Western populations when corrected for body weight. High PTAs (90%-100%) were predicted for Asian patients with CAP treated with ceftaroline fosamil, covering MIC 90  values of target CAP pathogens from the region. Similarly, >90% PTAs were predicted at EUCAST and FDA/CLSI clinical break points for these pathogens. These results support the use of the ceftaroline fosamil dosing regimens approved in Europe and the United States in Asian patients with PORT III-IV CAP.",2019,"High PTAs (90%-100%) were predicted for Asian patients with CAP treated with ceftaroline fosamil, covering MIC 90  values of target CAP pathogens from the region.","['Asian patients with community-acquired pneumonia (CAP) treated with ceftaroline fosamil', 'Asian patients with PORT III-IV CAP', '5000 Asian patients with', 'healthy Chinese volunteers', 'hospitalized Asian patients with Pneumonia Outcomes Research Team (PORT) risk class III-IV community-acquired pneumonia (NCT01371838', 'Asian Patients With']","['CAP', 'ceftaroline fosamil', 'Ceftaroline Fosamil']",['probability of PK/pharmacodynamic (PK/PD) target attainment (PTA'],"[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}]",5000.0,0.0228734,"High PTAs (90%-100%) were predicted for Asian patients with CAP treated with ceftaroline fosamil, covering MIC 90  values of target CAP pathogens from the region.","[{'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'AstraZeneca, Waltham, MA, USA.'}, {'ForeName': 'Shampa', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Diansong', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'AstraZeneca, Waltham, MA, USA.'}, {'ForeName': 'Nidal', 'Initials': 'N', 'LastName': 'Al-Huniti', 'Affiliation': 'AstraZeneca, Waltham, MA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.673']
2610,31518058,Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017-2018.,"INTRODUCTION


Many African countries have had at least two years' experience with universal treatment eligibility for HIV. The literature contains few descriptions, though, of populations starting treatment since adoption of universal eligibility. Using baseline data from a clinical trial of same-day ART initiation, we describe the populations presenting for HIV testing or care at study clinics in Kenya and South Africa in 2017-18, during the era of same-day initiation.
METHODS


The Simplified Algorithm for Treatment Eligibility (SLATE) trials in Kenya (SLATE I) and South Africa (SLATE II) were multicenter, non-blinded, individually randomized, pragmatic trials evaluating simple, standardized algorithms to determine eligibility for same-day initiation of ART without relying on laboratory results, point of care tests or multiple clinic visits. In Kenya, enrolment occurred during July 2017 to April 2018. In South Africa, enrolment occurred during March to September 2018. We describe demographic, socioeconomic and clinical characteristics of patients randomized to the same-day initiation arm for both studies.
RESULTS AND DISCUSSION


A total of 240 and 296 participants were enrolled in Kenya and South Africa. The majority were female (59% and 64% respectively), with a median age of 35 years. In both countries, most subjects were newly diagnosed with HIV on the day of enrolment (62%, 55%), believed they already had adequate knowledge to begin ART (78%, 68%), and preferred to start ART immediately (same-day) (98% in both countries). About 40% of all patients had at least one symptom related to tuberculosis (cough, fever, night sweats, weight loss) and/or cryptococcal meningitis (continuous headache). More than a third of patients (37%, 36%) presented with advanced disease (CD4 <200 cells/mm 3  ), a fifth presented with very advanced disease (CD4 < 100), and approximately 1 in 20 presented with very advanced disease and were asymptomatic.
CONCLUSIONS


Despite >2 years of universal eligibility for ART in Kenya and South Africa, in 2017-2018 more than half of HIV-positive patients presenting at public sector clinics were not yet aware of their status, and more than a third presented for care with advanced HIV disease. These proportions remain similar to those observed before the introduction of universal eligibility.",2019,"More than a third of patients (37%, 36%) presented with advanced disease (CD4 <200 cells/mm 3  ), a fifth presented with very advanced disease (CD4 < 100), and approximately 1 in 20 presented with very advanced disease and were asymptomatic.
","['A total of 240 and 296 participants were enrolled in Kenya and South Africa', 'Kenya', ""Many African countries have had at least two years' experience with universal treatment eligibility for HIV"", 'patients presenting in Kenya and South Africa in 2017-2018', 'populations presenting for HIV testing or care at study clinics in Kenya and South Africa in 2017-18, during the era of same-day initiation', 'Despite >2\xa0years of universal eligibility for ART in Kenya and South Africa, in 2017-2018 more than half of HIV-positive patients presenting at public sector clinics']",[],"['adequate knowledge to begin ART', 'tuberculosis (cough, fever, night sweats, weight loss) and/or cryptococcal meningitis (continuous headache']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0454695', 'cui_str': 'African country'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}]",[],"[{'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",,0.26606,"More than a third of patients (37%, 36%) presented with advanced disease (CD4 <200 cells/mm 3  ), a fifth presented with very advanced disease (CD4 < 100), and approximately 1 in 20 presented with very advanced disease and were asymptomatic.
","[{'ForeName': 'Alana T', 'Initials': 'AT', 'LastName': 'Brennan', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Maskew', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Larson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Tsikhutsu', 'Affiliation': 'Kenya Medical Research Institute/U.S. Army Medical Research Directorate-Africa, Nairobi, Kenya.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bii', 'Affiliation': 'Kenya Medical Research Institute/U.S. Army Medical Research Directorate-Africa, Nairobi, Kenya.'}, {'ForeName': 'Lungisile', 'Initials': 'L', 'LastName': 'Vezi', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Willem Df', 'Initials': 'WD', 'LastName': 'Venter', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25358']
2611,32032540,Time-varying risk of microvascular complications in latent autoimmune diabetes of adulthood compared with type 2 diabetes in adults: a post-hoc analysis of the UK Prospective Diabetes Study 30-year follow-up data (UKPDS 86).,"BACKGROUND


Latent autoimmune diabetes of adulthood (LADA) differs in clinical features from type 2 diabetes. Whether this difference translates into different risks of complications remains controversial. We examined the long-term risk of microvascular complications in people enrolled in the UK Prospective Diabetes Study (UKPDS), according to their diabetes autoimmunity status.
METHODS


We did a post-hoc analysis of 30-year follow-up data from UKPDS (UKPDS 86). UKPDS participants with diabetes autoantibody measurements available and without previous microvascular events were included. Participants with at least one detectable autoantibody were identified as having latent autoimmune diabetes, and those who tested negative for all autoantibodies were identified as having type 2 diabetes. The incidence of the primary composite microvascular outcome (first occurrence of renal failure, renal death, blindness, vitreous haemorrhage, or retinal photocoagulation) was compared between adults with latent autoimmune diabetes and those with type 2 diabetes. The follow-up ended on Sept 30, 2007. Baseline and updated 9-year mean values of potential confounders were tested in Cox models to adjust hazard ratios (HRs). UKPDS is registered at the ISRCTN registry, 75451837.
FINDINGS


Among the 5028 participants included, 564 had latent autoimmune diabetes and 4464 had type 2 diabetes. After median 17·3 years (IQR 12·6-20·7) of follow-up, the composite microvascular outcome occurred in 1041 (21%) participants. The incidence for the composite microvascular outcome was 15·8 (95% CI 13·4-18·7) per 1000 person-years in latent autoimmune diabetes and 14·2 (13·3-15·2) per 1000 person-years in type 2 diabetes. Adults with latent autoimmune diabetes had a lower risk of the composite outcome during the first 9 years of follow-up than those with type 2 diabetes (adjusted HR 0·45 [95% CI 0·30-0·68], p<0·0001), whereas in subsequent years their risk was higher than for those with type 2 diabetes (1·25 [1·01-1·54], p=0·047). Correcting for the higher updated 9-year mean HbA 1c  seen in adults with latent autoimmune diabetes than in those with type 2 diabetes explained entirely their subsequent increased risk for the composite microvascular outcome (adjusted HR 0·99 [95% CI 0·80-1·23], p=0·93).
INTERPRETATION


At diabetes onset, adults with latent autoimmune diabetes have a lower risk of microvascular complications followed by a later higher risk of complications than do adults with type 2 diabetes, secondary to worse glycaemic control. Implementing strict glycaemic control from the time of diagnosis could reduce the later risk of microvascular complications in adults with latent autoimmune diabetes.
FUNDING


European Foundation for the Study of Diabetes Mentorship Programme (AstraZeneca).",2020,The incidence for the composite microvascular outcome was 15·8 (95% CI 13·4-18·7) per 1000 person-years in latent autoimmune diabetes and 14·2,"['latent autoimmune diabetes of adulthood compared with type 2 diabetes in adults', 'Adults with latent autoimmune diabetes', '5028 participants included, 564 had latent autoimmune diabetes and 4464 had type 2 diabetes', 'adults with latent autoimmune diabetes', 'UKPDS participants with diabetes autoantibody measurements available and without previous microvascular events', 'Participants with at least one detectable autoantibody were identified as having latent autoimmune diabetes, and those who tested negative for all autoantibodies were identified as having type 2 diabetes', 'people enrolled in the UK Prospective Diabetes Study (UKPDS), according to their diabetes autoimmunity status']",[],"['microvascular complications', 'renal failure, renal death, blindness, vitreous haemorrhage, or retinal photocoagulation', 'composite microvascular outcome']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1272321', 'cui_str': 'Autoantibody measurement'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",[],"[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.104055,The incidence for the composite microvascular outcome was 15·8 (95% CI 13·4-18·7) per 1000 person-years in latent autoimmune diabetes and 14·2,"[{'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Maddaloni', 'Affiliation': 'Experimental Medicine Department, Sapienza University of Rome, Rome, Italy; Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK. Electronic address: ernesto.maddaloni@uniroma1.it.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK.'}, {'ForeName': 'Olorunsola', 'Initials': 'O', 'LastName': 'Agbaje', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Buzzetti', 'Affiliation': 'Experimental Medicine Department, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30003-6']
2612,30768860,The Relative Bioavailability and Effects of Food and Acid-Reducing Agents on Filgotinib Tablets in Healthy Subjects.,"Filgotinib is a potent, selective Janus kinase-1 inhibitor being developed to treat chronic inflammatory diseases. This phase 1 study in healthy subjects evaluated the relative bioavailability of filgotinib maleate tablets versus the reference tablet (filgotinib hydrochloride) and effects of food and acid-reducing agents (ARAs) on the pharmacokinetics of filgotinib and its major metabolite. Noncompartmental pharmacokinetic parameters of filgotinib and its major metabolite were compared between the 2 tablets at 100- and 200-mg doses and with or without food or ARAs. Filgotinib maleate tablets resulted in equivalent plasma exposures (area under concentration-time curve to infinity [AUC ∞  ] and maximum concentration [C max  ]) of filgotinib and its metabolite as the reference tablet (90%CIs of geometric least-squares mean ratios were within the prespecified no-effect boundary of 70% to 143%). Food intake had no effect on filgotinib AUC ∞  , but a high-fat meal reduced C max  by 20%. Coadministration of filgotinib with omeprazole or famotidine had no effect on filgotinib AUC ∞  , but omeprazole decreased C max  by 27%. Neither food nor ARAs affected metabolite exposure. Single-dose filgotinib 100 or 200 mg was well tolerated. This study supports evaluation of filgotinib maleate tablets, administered without regard to food or ARAs, in future clinical studies.",2019,"Coadministration of filgotinib with omeprazole or famotidine had no effect on filgotinib AUC ∞  , but omeprazole decreased C max  by 27%.","['healthy subjects', 'Healthy Subjects']","['Filgotinib maleate tablets', 'omeprazole', 'omeprazole or famotidine', 'filgotinib maleate tablets', 'Food and Acid-Reducing Agents', 'food and acid-reducing agents (ARAs']","['mean ratios', 'equivalent plasma exposures (area under concentration-time curve to infinity [AUC ∞  ] and maximum concentration [C max  ]) of filgotinib and its metabolite as the reference tablet (90%CIs of geometric least-squares', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0376446', 'cui_str': 'Reductants'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}]",,0.0329231,"Coadministration of filgotinib with omeprazole or famotidine had no effect on filgotinib AUC ∞  , but omeprazole decreased C max  by 27%.","[{'ForeName': 'Kacey', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kotecha', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cuvin', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Scott', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Shringi', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Acerta Pharma, South San Francisco, CA, USA.'}, {'ForeName': 'Ann Ran-Ran', 'Initials': 'AR', 'LastName': 'Qin', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Namour', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Horizon Pharma, Brisbane, CA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.659']
2613,32666652,Promoting engagement in physical activity in early rheumatoid arthritis: A proof-of-concept intervention study.,"OBJECTIVE(S)


The aim of this study is to test the feasibility and acceptability of promoting engagement in physical activity in early rheumatoid arthritis (PEPA-RA) to inform a future trial.
DESIGN


A 'proof of concept' study was carried out.
SETTING


This study was conducted in community hospitals delivered by musculoskeletal primary care physiotherapists.
PARTICIPANTS


Participants were 12 adults with rheumatoid arthritis (RA) diagnosed 6-24 months previously (nine females, three males; mean age 58 years, range 23-79).
INTERVENTION


The intervention consisted of five sessions, that is, four group sessions and one individual session facilitated by a physiotherapist over 12 weeks including patient education and support for behaviour change as well as supervised practical exercise.
MAIN OUTCOMES


The main outcomes were attendance, completion of outcome measures, adverse events, and participant and physiotherapist feedback views relating to the intervention.
RESULTS


Overall attendance was 85%, with sessions missed due to illness or RA flare. Outcome measure completion ranged from 83% to 100%. There were no clinically meaningful changes in pain or function at 12 weeks, but mean 6-min walk distance improved from 394 to 440 m. No serious adverse events were reported, and participants were generally positive about the intervention. Suggested minor modifications for the group sessions included venue accessibility and ensuring that physical activity time was protected. Several participants indicated that they would have liked to receive the intervention earlier following diagnosis.
CONCLUSIONS


PEPA-RA and the outcomes appear feasible and acceptable. Overall, small beneficial effects were noted at 12 weeks for most outcomes. Challenges to recruitment resulted in a smaller than anticipated sample size, and the majority of participants were active at baseline indicating that future recruitment needs to target less active individuals.",2020,"There were no clinically meaningful changes in pain or function at 12 weeks, but mean 6-min walk distance improved from 394 to 440 m.","['Participants were 12 adults with rheumatoid arthritis (RA) diagnosed 6-24 months previously (nine females, three males; mean age 58 years, range 23-79', 'early rheumatoid arthritis (PEPA-RA', 'community hospitals delivered by musculoskeletal primary care physiotherapists', 'early rheumatoid arthritis']",['individual session facilitated by a physiotherapist over 12 weeks including patient education and support for behaviour change as well as supervised practical exercise'],"['illness or RA flare', 'attendance, completion of outcome measures, adverse events, and participant and physiotherapist feedback views relating to the intervention', 'pain or function', 'serious adverse events', 'mean 6-min walk distance', 'small beneficial effects', 'venue accessibility and ensuring that physical activity time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",12.0,0.11645,"There were no clinically meaningful changes in pain or function at 12 weeks, but mean 6-min walk distance improved from 394 to 440 m.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Haase', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Domaille', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Manns', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Swales', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hurfurt', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Nicola E', 'Initials': 'NE', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}]",Musculoskeletal care,['10.1002/msc.1493']
2614,32666822,Long- versus short-term androgen deprivation therapy with high-dose radiotherapy for biochemical failure after radical prostatectomy: a randomized controlled trial.,"Radical prostatectomy is a well-established treatment option in the management of localized and locally advanced prostate cancer. An extended lymphadenectomy is performed in case of substantial risk for lymph node involvement. When biochemical recurrence (BCR) occurs, salvage radiotherapy (SRT) is performed. The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established. Retrospective evidence suggests that a longer schedule of ADT may be more beneficial compared with 6 months. This multicenter open-label randomized trial will include patients who need SRT after experiencing BCR post-radical prostatectomy with lymphadenectomy and pN0-status. Patients will be randomized for ADT duration (6 vs 24 months). Primary end point is distant metastasis-FS. Clinical Trial Registration: NCT04242017 (ClinicalTrials.gov).",2020,The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established.,"['patients who need SRT after experiencing BCR post-radical prostatectomy with lymphadenectomy and pN0-status', 'localized and locally advanced prostate cancer', 'biochemical failure after radical prostatectomy']","['androgen deprivation therapy (ADT', 'Radical prostatectomy', 'Long- versus short-term androgen deprivation therapy with high-dose radiotherapy', 'salvage radiotherapy (SRT', 'SRT']","['distant metastasis-FS', 'BCR-free survival (FS) and metastasis-FS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.149434,The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established.,"[{'ForeName': 'Charlien', 'Initials': 'C', 'LastName': 'Berghen', 'Affiliation': 'Department of Radiation Oncology, KU\xa0Leuven, Leuven, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Urology, KU\xa0Leuven, Leuven, Belgium.'}, {'ForeName': 'Annouschka', 'Initials': 'A', 'LastName': 'Laenen', 'Affiliation': 'Department of Public Health & Primary Care, Interuniversity Institute for Biostatistics & Statistical Bioinformatics, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gaetan', 'Initials': 'G', 'LastName': 'Devos', 'Affiliation': 'Department of Urology, KU\xa0Leuven, Leuven, Belgium.'}, {'ForeName': 'Kato', 'Initials': 'K', 'LastName': 'Rans', 'Affiliation': 'Department of Radiation Oncology, KU\xa0Leuven, Leuven, Belgium.'}, {'ForeName': 'Karolien', 'Initials': 'K', 'LastName': 'Goffin', 'Affiliation': 'Department of Nuclear Medicine, KU\xa0Leuven, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'Department of Radiation Oncology, KU\xa0Leuven, Leuven, Belgium.'}, {'ForeName': 'Gert De', 'Initials': 'G', 'LastName': 'Meerleer', 'Affiliation': 'Department of Radiation Oncology, KU\xa0Leuven, Leuven, Belgium.'}]","Future oncology (London, England)",['10.2217/fon-2020-0390']
2615,32666826,Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals.,"BACKGROUND/AIMS


Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation.
METHODS


We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
RESULTS


Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4-96.7] and 89.8 [83.6-95.2], respectively;  P  = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3-46.3),  P  < 0.001.
CONCLUSION


Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.",2020,"Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
",[],['JAMA'],"['trial protocol adherence rate', 'Protocol adherence rates', 'median and interquartile protocol adherence rates']",[],[],"[{'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3.0,0.501073,"Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
","[{'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Bamat', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Osayame A', 'Initials': 'OA', 'LastName': 'Ekhaguere', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Lingqiao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Flannery', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Handley', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Herrick', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520941428']
2616,32666831,Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial.,"BACKGROUND/AIMS


Standard approaches to trial design and analyses can be inefficient and non-pragmatic. Failure to consider a range of outcomes impedes evidence-based interpretation and reduces power. Traditional approaches synthesizing information obtained from separate analysis of each outcome fail to incorporate associations between outcomes and recognize the cumulative nature of outcomes in individual patients, suffer from competing risk complexities during interpretation, and since efficacy and safety analyses are often conducted on different populations, generalizability is unclear. Pragmatic and efficient approaches to trial design and analyses are needed.
METHODS


Approaches providing a pragmatic assessment of benefits and harms of interventions, summarizing outcomes experienced by patients, and providing sample size efficiencies are described. Ordinal outcomes recognize finer gradations of patient responses. Desirability of outcome ranking is an ordinal outcome combining benefits and harms within patients. Analysis of desirability of outcome ranking can be based on rank-based methodologies including the desirability of outcome ranking probability, the win ratio, and the proportion in favor of treatment. Partial credit analyses, involving grading the levels of the desirability of outcome ranking outcome similar to an academic test, provides an alternative approach. The methodologies are demonstrated using the acute stroke or transient ischemic attack treated with aspirin or ticagrelor and patient outcomes study (SOCRATES; NCT01994720), a randomized clinical trial.
RESULTS


Two 5-level ordinal outcomes were developed for SOCRATES. The first was based on a modified Rankin scale. The odds ratio is 0.86 (95% confidence interval = 0.75, 0.99;  p  = 0.04) indicating that the odds of worse stroke categorization for a trial participant assigned to ticagrelor is 0.86 times that of a trial participant assigned to aspirin. The 5-level desirability of outcome ranking outcome incorporated and prioritized survival; the number of strokes, myocardial infarction, and major bleeding events; and whether a stroke event was disabling. The desirability of outcome ranking probability and win ratio are 0.504 (95% confidence interval = 0.499, 0.508;  p  = 0.10) and 1.11 (95% confidence interval = 0.98, 1.26;  p  = 0.10), respectively, implying that the probability of a more desirable result with ticagrelor is 50.4% and that a more desirable result occurs 1.11 times more frequently on ticagrelor versus aspirin.
CONCLUSION


Ordinal outcomes can improve efficiency through required pre-specification, careful construction, and analyses. Greater pragmatism can be obtained by composing outcomes within patients. Desirability of outcome ranking provides a global assessment of the benefits and harms that more closely reflect the experience of patients. The desirability of outcome ranking probability, the proportion in favor of treatment, the win ratio, and partial credit can more optimally inform patient treatment, enhance the understanding of the totality of intervention effects on patients, and potentially provide efficiencies over standard analyses. The methods provide the infrastructure for incorporating patient values and estimating personalized effects.",2020,"The odds ratio is 0.86 (95% confidence interval = 0.75, 0.99;  p  = 0.04) indicating that the odds of worse stroke categorization for a trial participant assigned to ticagrelor is 0.86 times that of a trial participant assigned to aspirin.",[],"['aspirin', 'aspirin or ticagrelor', 'ticagrelor']","['prioritized survival; the number of strokes, myocardial infarction, and major bleeding events; and whether a stroke event was disabling']",[],"[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.138628,"The odds ratio is 0.86 (95% confidence interval = 0.75, 0.99;  p  = 0.04) indicating that the odds of worse stroke categorization for a trial participant assigned to ticagrelor is 0.86 times that of a trial participant assigned to aspirin.","[{'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': 'Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Centre, Bichat Hospital, Paris University, Paris, France.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Jonasson', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Ks Lawrence', 'Initials': 'KL', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine & Therapeutics, Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas at Austin, Austin, TX, USA.""}]","Clinical trials (London, England)",['10.1177/1740774520941441']
2617,32666858,Predictors of employment in people with moderate to severe mental illness participating in a randomized controlled trial of Individual Placement and Support (IPS).,"BACKGROUND


Many people with moderate to severe mental illness have a desire to obtain ordinary employment. To aid further development of health and social services for this group, the aim of this study was to examine candidate modifiable and prognostic markers of employment, and moderating effects of group allocation in a clinical trial.
METHOD


The sample consists of 327 patients in treatment for mental illness, randomized to Individual Placement and Support (IPS) or treatment as usual (TAU) as part of a clinical trial. Psychosocial and demographic baseline characteristics were included as predictors in log binary regression analyses with employment 18 months after inclusion as the outcome, and group allocation as the moderator (IPS or TAU).
RESULTS


Directive emotional support and non-directive instrumental support seemed to positively predict employment, but effects were small. Involuntary hospitalization seemed to be a strong negative predictor of employment. Group allocation did not moderate any main effects.
CONCLUSION


Interpretation of the findings suggest that attention should be given to certain aspects of health and social services provided to this target group, and in particular the effect of receiving appropriate types of social support. The findings are novel because social support and involuntary hospitalization do not seem to have been included in previous predictor studies. The results from this study identify new topics for research on employment outcomes for this population.",2020,"Group allocation did not moderate any main effects.
","['people with moderate to severe mental illness participating', '327 patients in treatment for mental illness', 'people with moderate to severe mental illness']","['Individual Placement and Support (IPS', 'Individual Placement and Support (IPS) or treatment as usual (TAU']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0980507,"Group allocation did not moderate any main effects.
","[{'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Fyhn', 'Affiliation': 'NORCE, Bergen, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Øverland', 'Affiliation': 'Norwegian Institute of Public Health, Bergen, Norway.'}, {'ForeName': 'Silje E', 'Initials': 'SE', 'LastName': 'Reme', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}]",The International journal of social psychiatry,['10.1177/0020764020934841']
2618,32666905,Development and application of an electronic treatment register: a system for enumerating populations and monitoring treatment during mass drug administration.,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration. The electronic treatment register was designed in xlsform, deployed via the SurveyCTO mobile data collection platform, and implemented on smartphones running the Android operating system. The versatile system enables collection of census and treatment status information, facilitates data aggregation and visualisation, and permits real-time feedback loops during implementation of mass drug administration. Here we describe the system's design and use within the DeWorm3 Project and key features, and by sharing the register here, we hope our readers will further explore its use within their research and disease-control activities.",2020,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration.",[],[],[],[],[],[],,0.0575259,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Oswald', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Kennedy', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Farzana', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Saravanakumar Puthupalayam', 'Initials': 'SP', 'LastName': 'Kaliappan', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Eloic', 'Initials': 'E', 'LastName': 'Atindegla', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Parfait', 'Initials': 'P', 'LastName': 'Houngbégnon', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chisambi', 'Affiliation': 'Blantyre Institute for Community Outreach, Lions Sight First Eye Hospital , Blantyre, Malawi.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Witek-McManus', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine , London, UK.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Galagan', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Emmanuel-Fabula', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Gwayi-Chore', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Legge', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Yard', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Lions Sight First Eye Hospital , Blantyre, Malawi.'}, {'ForeName': 'Moudachirou', 'Initials': 'M', 'LastName': 'Ibikounlé', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Sitara Swarna Rao', 'Initials': 'SSR', 'LastName': 'Ajjampur', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Arianna Rubin', 'Initials': 'AR', 'LastName': 'Means', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Kristjana H', 'Initials': 'KH', 'LastName': 'Ásbjörnsdóttir', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Halliday', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Judd L', 'Initials': 'JL', 'LastName': 'Walson', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}]",Global health action,['10.1080/16549716.2020.1785146']
2619,32666919,"Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Randomized Trial of Web-Based, Single-Session Interventions for Parents and Youths.",,2020,,"['Pediatric Primary Care Depression Screening', 'Parents and Youths']",[],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",[],[],,0.0520618,,"[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'Stony Brook University, New York. Electronic address: jessica.schleider@stonybrook.edu.'}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Dobias', 'Affiliation': 'Stony Brook University, New York.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fassler', 'Affiliation': 'Stony Brook University, New York.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Shroff', 'Affiliation': 'Stony Brook University, New York.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Pati', 'Affiliation': 'Division of Pediatric Primary Care, Stony Brook University, New York.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.01.025']
2620,32664282,"Changes in Metabolites During an Oral Glucose Tolerance Test in Early and Mid-Pregnancy: Findings from the PEARLS Randomized, Controlled Lifestyle Trial.","The oral glucose tolerance test (OGTT) is used to diagnose gestational and other types of diabetes. We examined metabolite changes during an OGTT, and how a comprehensive diet and physical activity intervention may influence these changes in a population of overweight/obese Hispanic pregnant women. Integration of changes in metabolites during an OGTT may help us gain preliminary insights into how glucose metabolism changes during pregnancy. Among women from the Pregnancy and EARly Lifestyle improvement Study (PEARLS), we measured metabolites during a multipoint OGTT (fasting, 30, 60 and 120 min) at early and mid-pregnancy. Metabolite levels were measured by liquid chromatography-mass spectrometry in plasma samples in the lifestyle intervention ( n  = 13) and control ( n  = 16) arms of the study. A total of 65 candidate metabolites were selected that displayed changes during an OGTT in previous studies. Paired and unpaired  t -tests were used to examine differences in Δfast-120 min: (1) at early and mid-pregnancy; and (2) by intervention assignment. We applied principal component analysis (PCA) to identify those metabolites that differed by intervention assignment and OGTT time points. Most of the characteristic changes in metabolites post-OGTT were similar at both gestational time points. PCA identified characteristic metabolite patterns associated with OGTT time points at both early and mid-pregnancy. These metabolites included ketone bodies, tryptophan, acyl carnitines, polyunsaturated fatty acids, and biomarkers related to bile acid, urea cycle, arginine, and proline metabolism. PCA identified distinct Δfast-120 min in fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels at mid- compared to early pregnancy. Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group. These findings provide preliminary insight into metabolites, whose role in increased insulin resistance during pregnancy, should be explored further in future studies.",2020,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"['population of overweight/obese Hispanic pregnant women', 'Early and Mid-Pregnancy']",['comprehensive diet and physical activity intervention'],"['Metabolite levels', 'fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels', 'oral glucose tolerance test (OGTT']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.0276949,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Haslam', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Marijulie', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Center for Clinical Research and Health Promotion, University of Puerto Rico Medical Sciences Campus, San Juan, PR 00936-5067, Puerto Rico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12, SE-214 28 Malmö, Sweden.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Shilpa N', 'Initials': 'SN', 'LastName': 'Bhupathiraju', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}]",Metabolites,['10.3390/metabo10070284']
2621,32664289,"Effects of PrObiotics on the Symptoms and Surgical ouTComes after Anterior REsection of Colon Cancer (POSTCARE): A Randomized, Double-Blind, Placebo-Controlled Trial.","We investigated microbiota changes following surgical colon cancer resection and evaluate effects of probiotics on microbiota and surgical recovery. This randomized double-blind trial was performed at four medical centers in South Korea. Of 68 patients expected to undergo anterior sigmoid colon cancer resection, 60 were eligible, of whom 29 and 31 received probiotics and placebo, respectively, for four weeks, starting at one week preoperatively. Third- and/or fourth-week information on anterior resection syndrome (ARS), inflammatory markers, and quality of life was obtained. Stool sample analysis was conducted after randomization and bowel preparation and at three and four postoperative weeks. Bacteria were categorized into Set I (with probiotic effects) and II (colon cancer-associated). The probiotic group's ARS score showed an improving trend ( p =  0.063), particularly for flatus control ( p =  0.030). Serum zonulin levels significantly decreased with probiotics. Probiotic ingestion resulted in compositional changes in gut microbiota; greater increases and decreases in Set I and II bacteria, respectively, occurred with probiotics. Compositional increase in Set I bacteria was associated with reduced white blood cells, neutrophils, neutrophil-lymphocyte ratio, and zonulin.  Bifidobacterium  composition was negatively correlated with zonulin levels in the probiotic group. Probiotics improved postoperative flatus control and modified postoperative changes in microbiota and inflammatory markers.",2020,"Probiotic ingestion resulted in compositional changes in gut microbiota; greater increases and decreases in Set I and II bacteria, respectively, occurred with probiotics.","['68 patients expected to undergo anterior sigmoid colon cancer resection, 60 were eligible, of whom 29 and 31 received', 'after Anterior REsection of Colon Cancer (POSTCARE', 'four medical centers in South Korea']","['Placebo', 'Probiotic ingestion', 'surgical colon cancer resection', 'PrObiotics', 'probiotics', 'probiotics and placebo']","['postoperative flatus control and modified postoperative changes in microbiota and inflammatory markers', 'zonulin levels', 'white blood cells, neutrophils, neutrophil-lymphocyte ratio, and zonulin', 'anterior resection syndrome (ARS), inflammatory markers, and quality of life', 'Symptoms and Surgical ouTComes', 'Serum zonulin levels', 'Set I and II bacteria', 'microbiota and surgical recovery', 'Bifidobacterium  composition', 'ARS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",68.0,0.423716,"Probiotic ingestion resulted in compositional changes in gut microbiota; greater increases and decreases in Set I and II bacteria, respectively, occurred with probiotics.","[{'ForeName': 'In Ja', 'Initials': 'IJ', 'LastName': 'Park', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Centre and University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.'}, {'ForeName': 'Ju-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Food Science and Biotechnology, Graduate School of Biotechnology, Kyung Hee University, 1732, Deogyeong-daero, Giheung-gu, Yongin-si, Gyeonggi-do 17104, Korea.'}, {'ForeName': 'Bong-Hyeon', 'Initials': 'BH', 'LastName': 'Kye', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do 16247, Korea.""}, {'ForeName': 'Heung-Kwon', 'Initials': 'HK', 'LastName': 'Oh', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, 300 Gumi-dong Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Korea.'}, {'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea.'}, {'ForeName': 'You-Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Biotechnology, Graduate School of Biotechnology, Kyung Hee University, 1732, Deogyeong-daero, Giheung-gu, Yongin-si, Gyeonggi-do 17104, Korea.'}, {'ForeName': 'Joo Yun', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'R&BD Centre, Korea Yakult Co. Ltd., 577, Gangnam-daero, Seocho-gu, Seoul 05505, Korea.'}, {'ForeName': 'Na Young', 'Initials': 'NY', 'LastName': 'Sung', 'Affiliation': 'National Cancer Control Institute, National Cancer Centre, 323 Ilsan-ro, Ilsandong-gu, Goyang-si Gyeonggi-do 10408, Korea.'}, {'ForeName': 'Sung-Bum', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, 300 Gumi-dong Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Korea.'}, {'ForeName': 'Jeong-Meen', 'Initials': 'JM', 'LastName': 'Seo', 'Affiliation': 'Division of Pediatric Surgery, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Ilwon-ro, Gangnam-gu, Seoul 06351, Korea.'}, {'ForeName': 'Jae-Hun', 'Initials': 'JH', 'LastName': 'Sim', 'Affiliation': 'R&BD Centre, Korea Yakult Co. Ltd., 577, Gangnam-daero, Seocho-gu, Seoul 05505, Korea.'}, {'ForeName': 'Jung-Lyoul', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'R&BD Centre, Korea Yakult Co. Ltd., 577, Gangnam-daero, Seocho-gu, Seoul 05505, Korea.'}, {'ForeName': 'In Kyu', 'Initials': 'IK', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Division of Colorectal Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea.""}]",Journal of clinical medicine,['10.3390/jcm9072181']
2622,32664290,Effects of Pre-Sleep Whey vs. Plant-Based Protein Consumption on Muscle Recovery Following Damaging Morning Exercise.,"Pre-sleep whey protein intake has been shown to improve overnight muscle protein synthesis, muscle size and strength, and muscle recovery. Despite a growing interest in alternative protein sources, such as plant-based protein, there is no evidence regarding the efficacy of plant-based proteins consumed pre-sleep. Therefore, we aimed to compare whey vs. plant-based pre-sleep protein dietary supplementation on muscle recovery in middle-aged men. Twenty-seven recreationally active, middle-aged men performed 5 sets of 15 repetitions of maximal eccentric voluntary contractions (ECC) for the knee extensors (ext) and flexors (flex), respectively, in the morning. Participants consumed 40 g of either whey hydrolysate (WH,  n  = 9), whey isolate (WI,  n  = 6), rice and pea combination (RP,  n  = 6), or placebo (PL,  n  = 6) 30 min pre-sleep on the day of ECC and the following two nights. Catered meals (15% PRO, 55% CHO, 30% Fat) were provided to participants for 5 days to standardize nutrition. Plasma creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10) were measured at pre, immediately post (+0), +4, +6, +24, +48, and +72 h post-ECC. Isometric (ISOM) and isokinetic (ISOK) maximal voluntary contraction force were measured at pre, immediately post (+0), +24, +48, and +72 h post-ECC. Muscle soreness, thigh circumference, and HOMA-IR were measured at pre, +24, +48, and +72 h post-ECC. CK was increased at +4 h post-ECC, remained elevated at all time points compared to baseline ( p  < 0.001), and was significantly greater at +72 h compared to all other time points ( p  < 0.001). IL-6 was increased at +6 h ( p  = 0.002) with no other time differing from baseline. ISOMext was reduced after ECC ( p  = 0.001) and remained reduced until returning to baseline at +72 h. ISOMflex, ISOKext, and ISOKflex were reduced after ECC and remained reduced at +72 h ( p  < 0.001). Muscle soreness increased post-ECC ( p  < 0.001) and did not return to baseline. Thigh circumference ( p  = 0.456) and HOMA-IR ( p  = 0.396) did not change post-ECC. There were no significant differences between groups for any outcome measure. These data suggest that middle-aged men consuming 1.08 ± 0.02 g/kg/day PRO did not recover from damaging eccentric exercise at +72 h and that pre-sleep protein ingestion, regardless of protein source, did not aid in muscle recovery when damaging eccentric exercise was performed in the morning.",2020,Thigh circumference ( p  = 0.456) and HOMA-IR ( p  = 0.396) did not change post-ECC.,"['Twenty-seven recreationally active, middle-aged men', 'middle-aged men']","['whey vs. plant-based pre-sleep protein dietary supplementation', 'maximal eccentric voluntary contractions (ECC', 'Pre-Sleep Whey vs. Plant-Based Protein Consumption', 'whey hydrolysate (WH,  n  = 9), whey isolate (WI,  n  = 6), rice and pea combination (RP,  n  = 6), or placebo (PL,  n  = 6) 30 min pre-sleep on the day of ECC']","['Muscle soreness', 'ISOMflex, ISOKext, and ISOKflex', 'HOMA-IR', 'Plasma creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10', 'ISOMext', 'Isometric (ISOM) and isokinetic (ISOK) maximal voluntary contraction force', 'IL-6', 'Muscle soreness, thigh circumference, and HOMA-IR', 'CK', 'Thigh circumference']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",,0.178006,Thigh circumference ( p  = 0.456) and HOMA-IR ( p  = 0.396) did not change post-ECC.,"[{'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Saracino', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Saylor', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Hanna', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hickner', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Jeong-Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}]",Nutrients,['10.3390/nu12072049']
2623,32664361,"Impact of Whole Body Electromyostimulation on Velocity, Power and Body Composition in Postmenopausal Women: A Randomized Controlled Trial.","Menopause is associated with losses in strength and power along with weight and fat mass gains, which may result from menopause-related hormonal changes, aging-associated diseases, and decreased physical activity time. The objective of this study is to analyze if whole-body electromyostimulation (WB-EMS) is suitable for the prevention and treatment of postmenopausal physical deterioration. Thirty-four healthy sedentary women between 55 and 69 years followed an experimental design pre-post test. Both groups conducted 10 weeks of aerobic and strength training program. The experimental group conducted the training with superimposed WB-EMS during exercise. At the end of the intervention, the experimental group obtained better power (Squat: mean difference (MD) = 38.69 W [1.75,75.62],  d  = 0.81; Bench press: MD = 25.64 W [17.48, 33.82],  d  = 2.39) and velocity (Squat: MD = 0.04 m·s -1  [0.01, 0.08],  d  = 0.98; Bench press: MD = 0.10 m·s -1  [0.06, 0.14],  d  = 1.90) score improvements than the other group ( p Bonferroni  < 0.05). Furthermore, trivial to small effects were found in the body composition of the participants of both groups ( p >  0.050). WB-EMS showed a favorable isolated effect on the development of power and velocity, but it induced negligible effects on the body composition of postmenopausal women.",2020,score improvements than the other group ( p Bonferroni  < 0.05).,"['Postmenopausal Women', 'postmenopausal women', 'Thirty-four healthy sedentary women between 55 and 69 years followed an experimental design pre-post test']","['whole-body electromyostimulation (WB-EMS', 'Whole Body Electromyostimulation', 'training with superimposed WB-EMS during exercise', 'aerobic and strength training program']","['body composition', 'Velocity, Power and Body Composition', 'score improvements', 'physical activity time']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0032919', 'cui_str': 'Pre-Post Tests'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",34.0,0.0381312,score improvements than the other group ( p Bonferroni  < 0.05).,"[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pano-Rodriguez', 'Affiliation': 'Research Group Human Movement, University of Lleida, E-25001 Lleida, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Beltran-Garrido', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, 43870 Tarragona, Spain.'}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Hernandez-Gonzalez', 'Affiliation': 'Nutritional Coaching SL, 08011 Barcelona, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Nasarre-Nacenta', 'Affiliation': 'Nutritional Coaching SL, 08011 Barcelona, Spain.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Reverter-Masia', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, 43870 Tarragona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17144982']
2624,32664643,Effects of 6 Weeks Direct Instruction and Teaching Games for Understanding Programs on Physical Activity and Tactical Behaviour in U-12 Soccer Players.,"The purpose of this study was to compare the effects of 6 weeks direct instruction and teaching games for understanding (TGfU) programs on the decision-making and execution (post-interventions), as well, as on the physical activity (PA) levels during sessions. Thirty under-12 football players participated in this study (age: 10.3 ± 0.45 years) and were randomly assigned to TGfU ( n  = 15) or direct instruction ( n  = 15) group. Two sessions/week were implemented. Results revealed that TGfU promoted higher levels ( p  = 0.043; d = 2.99) of light PA (28.96%) compared with direct instruction (27.55%). Non-significant higher sedentary PA levels ( p  = 0.073; d = 2.62) were found in the control group (35.48%). In terms of tactical principles, conservation of the ball increased the percentage of moderate to vigorous physical activity in TGfU (43.60%) compared with direct instruction (38.05%). According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2). TGfU seems to be more appropriate than direct instruction to increase the light PA levels during sessions while no significant differences were found between programs in moderate and vigorous intensities. Regarding the effects of programs in decisions, greater improvements in decisions with the ball were found in TGFU compared to DI.",2020,"According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2).","['Thirty under-12 football players participated in this study (age: 10.3 ± 0.45 years', 'U-12 Soccer Players']","['TGfU', '6 Weeks Direct Instruction and Teaching Games', 'direct instruction']","['light PA levels', 'Physical Activity and Tactical Behaviour', 'sedentary PA levels', 'physical activity (PA) levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]",,0.01403,"According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2).","[{'ForeName': 'Juan Vicente', 'Initials': 'JV', 'LastName': 'Sierra-Ríos', 'Affiliation': 'Physical Education Department, Faculty of Education, University of Castilla-La Mancha, 16071 Cuenca, Spain.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Rey', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Sixto', 'Initials': 'S', 'LastName': 'González-Víllora', 'Affiliation': 'Physical Education Department, Faculty of Education, University of Castilla-La Mancha, 16071 Cuenca, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17145008']
2625,32664779,Cryoanalgesic versus EMLA® cream to reduced pain during analgesic injection in upper eyelid surgery: a randomized trial.,"INTRODUCTION


Eyelid surgery under local anesthesia is a common procedure in ophthalmology. The most painful part is usually injecting local anesthesia. Decreased sensation from the very sensitive eyelid skin before injection is one of the few methods to relieve this stressful condition. In this study, we compared the use of the aesthetic property of cooling (cryoanalgesic) with topical EMLA® cream preparation before local anesthetic injection on the eyelid.
METHODS


Thirty patients aged 47-81 years (mean = 65.6, SD = 9.75) undergoing upper eyelid blepharoplasty or levator advancement surgery were enrolled. Each subject's upper eyelid was randomly allocated by a computer-generated randomization sequence to an EMLA® cream or cryoanalgesic group before injecting local anesthetic. Pain monitoring was performed subjectively and objectively using a visual analog scale (VAS). Results were analyzed using the paired t-test.
RESULTS


No statistical difference was found in VAS score between the EMLA® cream (mean = 5.9) and cryoanalgesic groups (mean = 5.67) ( p -value 0.5999).
CONCLUSION


Topical EMLA® cream and cryoanalgesic have no difference in pain score from anesthetic infiltration during eyelid surgery.",2020,"No statistical difference was found in VAS score between the EMLA® cream (mean = 5.9) and cryoanalgesic groups (mean = 5.67) ( p -value 0.5999).
","['upper eyelid surgery', 'Thirty patients aged 47-81\xa0years (mean\xa0=\xa065.6, SD\xa0=\xa09.75) undergoing upper eyelid blepharoplasty or levator advancement surgery were enrolled', ""Each subject's upper eyelid""]","['EMLA® cream or cryoanalgesic group before injecting local anesthetic', 'Eyelid surgery under local anesthesia', 'Cryoanalgesic versus EMLA® cream', 'cooling (cryoanalgesic) with topical EMLA® cream', 'EMLA® cream']","['VAS score', 'visual analog scale (VAS', 'Decreased sensation', 'pain', 'pain score']","[{'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0197216', 'cui_str': 'Blepharoplasty of upper eyelid'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]","[{'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",30.0,0.0439523,"No statistical difference was found in VAS score between the EMLA® cream (mean = 5.9) and cryoanalgesic groups (mean = 5.67) ( p -value 0.5999).
","[{'ForeName': 'Sombat', 'Initials': 'S', 'LastName': 'Tanaboonyawat', 'Affiliation': 'Department of Ophthalmology, Phramongkutklao College of Medicine , Bangkok, Thailand.'}, {'ForeName': 'Raveevan', 'Initials': 'R', 'LastName': 'Choontanom', 'Affiliation': 'Department of Ophthalmology, Phramongkutklao College of Medicine , Bangkok, Thailand.'}]","Orbit (Amsterdam, Netherlands)",['10.1080/01676830.2020.1789180']
2626,32664809,Outcomes from a Pilot Patient-Centered Hospital-to-Home Transition Program for Children Hospitalized with Asthma.,"Objective:  To evaluate a multi-component hospital-to-home (H2H) transition program for children hospitalized with an asthma exacerbation. Methods:  A pilot prospective randomized clinical trial of guideline-based asthma care with and without a patient-centered multi-component H2H program among children enrolled in K-8 th  grade on Medicaid hospitalized for an asthma exacerbation. H2H program includes 5 components: medications in-hand at discharge, school-based asthma therapy (SBAT) for controller medications, referral for home trigger assessments, communication with the primary care provider (PCP), and patient navigator support. Primary outcomes included feasibility and acceptability. Secondary outcomes included healthcare utilization, asthma morbidity, and caregiver quality of life. Results:  A total of 32 children were enrolled and randomized. Feasibility outcomes in the intervention group included: medications in-hand at discharge (100%); SBAT for controller medication initiated (100%); home visit referrals made (100%) and home visits completed within 4 weeks of discharge (44%); PCP communication (100%); patient navigator communication at 3 days (81.3%) and 14 days (46.7%). Acceptability outcomes in the intervention group included: 87.5% of families continued SBAT, and 87.5% of families reported it was extremely helpful to have the home visit referral. Adjusting for baseline differences in age, asthma severity and control, there was no significant difference in healthcare utilization outcomes. Conclusion:  These pilot data suggest that comprehensive care coordination initiated during the inpatient stay is feasible and acceptable. A larger trial is justified to determine if the intervention may reduce healthcare utilization for urban, minority children with asthma.",2020,"Adjusting for baseline differences in age, asthma severity and control, there was no significant difference in healthcare utilization outcomes.","['children hospitalized with an asthma exacerbation', 'Children Hospitalized with Asthma', '32 children', 'urban, minority children with asthma', 'children enrolled in K-8 th  grade on Medicaid hospitalized for an asthma exacerbation']","['multi-component hospital-to-home (H2H) transition program', 'H2H program includes 5 components: medications in-hand at discharge, school-based asthma therapy (SBAT) for controller medications, referral for home trigger assessments, communication with the primary care provider (PCP), and patient navigator support', 'guideline-based asthma care with and without a patient-centered multi-component H2H program']","['feasibility and acceptability', 'healthcare utilization outcomes', 'healthcare utilization, asthma morbidity, and caregiver quality of life', 'Acceptability outcomes', 'patient navigator communication']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",32.0,0.0853024,"Adjusting for baseline differences in age, asthma severity and control, there was no significant difference in healthcare utilization outcomes.","[{'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Parikh', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington DC.""}, {'ForeName': 'Miller', 'Initials': 'M', 'LastName': 'Richmond', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington DC.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington DC.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington DC.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McCarter', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington DC.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Hinds', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington DC.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington DC.""}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1795877']
2627,31132578,"Sleep regularity is associated with sleep-wake and circadian timing, and mediates daytime function in Delayed Sleep-Wake Phase Disorder.","BACKGROUND


In healthy populations, irregular sleep patterns are associated with delayed sleep and poor functional/mood outcomes. Currently, it is unknown whether irregular sleep contributes to poor functional/mood outcomes in individuals with Delayed Sleep-Wake Phase Disorder (DSWPD).
METHODS


In 170 patients with DSWPD, we collected sleep-wake patterns, dim light melatonin onset (DLMO), and functional/mood outcomes. The Sleep Regularity Index (SRI) and other sleep timing metrics were computed. Correlations of SRI were computed with phase angle (difference between DLMO and desired bedtime), sleep timing and quality variables, daytime function, sleep-related daytime impairment, mood, and insomnia symptom severity. Path analyses assessed whether SRI or total sleep time mediated the associations between sleep onset time and phase angle with daytime functioning, sleep-related impairment, and mood outcomes.
RESULTS


Higher SRI was associated with earlier sleep and longer total sleep time, but did not relate to sleep quality, daytime function, or mood outcomes. Path analysis showed that phase angle was directly associated with all outcome variables, whereas sleep onset time was not directly associated with any. SRI mediated the effects of sleep onset time and phase angle on daytime function. Total sleep time mediated the effects of sleep onset time and phase angle on sleep-related impairment.
CONCLUSION


Individuals with DSWPD who have more delayed sleep and a greater phase angle also have more irregular sleep. This suggests that it is not delayed sleep timing per se that drives poor functional outcomes in DSWPD, but rather the timing of sleep relative to circadian phase and resultant irregular sleep patterns.",2019,"Higher SRI was associated with earlier sleep and longer total sleep time, but did not relate to sleep quality, daytime function, or mood outcomes.","['170 patients with DSWPD', 'individuals with Delayed Sleep-Wake Phase Disorder (DSWPD']",[],"['collected sleep-wake patterns, dim light melatonin onset (DLMO), and functional/mood outcomes', 'sleep onset time and phase angle with daytime functioning, sleep-related impairment, and mood outcomes', 'delayed sleep', 'SRI or total sleep time', 'Total sleep time', 'sleep onset time and phase angle on sleep-related impairment', 'Sleep Regularity Index (SRI', 'earlier sleep and longer total sleep time', 'DLMO and desired bedtime), sleep timing and quality variables, daytime function, sleep-related daytime impairment, mood, and insomnia symptom severity', 'sleep onset time and phase angle on daytime function', 'sleep onset time', 'sleep quality, daytime function, or mood outcomes']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393770', 'cui_str': 'Sleep-wake schedule disorder, delayed phase type'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",170.0,0.0274747,"Higher SRI was associated with earlier sleep and longer total sleep time, but did not relate to sleep quality, daytime function, or mood outcomes.","[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Murray', 'Affiliation': 'School of Psychological Sciences, Monash University, Clayton, Victoria, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Phillips', 'Affiliation': 'School of Psychological Sciences, Monash University, Clayton, Victoria, Australia. Electronic address: andrew.phillips@monash.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Magee', 'Affiliation': 'School of Psychological Sciences, Monash University, Clayton, Victoria, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Sletten', 'Affiliation': 'School of Psychological Sciences, Monash University, Clayton, Victoria, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia; Woolcock Institute of Medical Research and Sydney Local Health District, Sydney, New South Wales, Australia; University of Sydney Susan Wakil School of Nursing, New South Wales, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lovato', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Bei', 'Affiliation': 'School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia; Woolcock Institute of Medical Research and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kennaway', 'Affiliation': 'Robinson Research Institute and School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Leon C', 'Initials': 'LC', 'LastName': 'Lack', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia; Woolcock Institute of Medical Research and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""School of Psychological Sciences, Monash University, Clayton, Victoria, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': ""School of Psychological Sciences, Monash University, Clayton, Victoria, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia; NHMRC Centre for Sleep and Circadian Neurobiology, Sydney, New South Wales, Australia; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sleep medicine,['10.1016/j.sleep.2019.03.009']
2628,32664877,"Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial.","BACKGROUND


Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.
METHODS


Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.
RESULTS


In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.
CONCLUSIONS


The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.
TRIAL REGISTRATION


Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019.",2020,"Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004).","['937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior', 'stroke patients', 'Patients with acute ischemic stroke', 'patients with acute ischemic stroke']","['intravenous infusion of 320\u2009mg cinepazide maleate or placebo', 'Cinepazide maleate injection', 'cinepazide maleate', 'Thrombolytic therapy', 'basic therapy (citicoline sodium', 'cinepazide maleate injection', 'placebo']","['disability and survival rates', 'adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram', 'safety parameters', 'proportion of patients with an mRS score\u2009≤\u20092', 'Efficacy and safety', 'efficacy and safety', 'neurological function and activities of daily living, reducing disability', 'proportion of patients with a modified Rankin scale (mRS', 'cerebral collateral circulation', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0055741', 'cui_str': 'cinepazide maleate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3153694', 'cui_str': 'Citicoline sodium'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0009348', 'cui_str': 'Collateral circulation'}]",937.0,0.26888,"Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Guofang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Tianjin Huanhu Hospital, Tianjin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': ""Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Zhuobo', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'First Bethune Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Lishui Municipal Central Hospital, Lishui, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Shao', 'Affiliation': 'First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dalian Municipal Central Hospital, Dalian, China.'}, {'ForeName': 'Yafang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Huangshi Central Hospital, Huangshi, China.'}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': ""Jiangxi Provincial People's Hospital affiliated to Nanchang University, Nanchang, China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""Hengshui People's Hospital (Harrison International Peace Hospital), Hengshui, China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Xuan Wu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Lü', 'Affiliation': ""Shaanxi Provincial People's Hospital, Xi'an, China.""}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yonghua', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Seventh Medical Center of the Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xiao', 'Affiliation': 'Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Gong', 'Affiliation': 'Beijing Hospital, Beijing, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. pumchcuily@sina.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC neurology,['10.1186/s12883-020-01844-8']
2629,32664934,Protect MSM from HIV and other sexually transmitted diseases by providing mobile health services of partner notification: protocol for a pragmatic stepped wedge cluster randomized controlled trial.,"BACKGROUND


Recently, more and more men who have sex with men (MSM) look for casual partners through online dating platforms in China. However, most are unable to know their partners' HIV and other sexually transmitted diseases (STD) statuses, leading to the rapid increase in HIV infection among Chinese MSM. Effective partner notification is urgently needed to increase the risk awareness of MSM and prevent HIV and other STDs transmission. However, the traditional intervention mainly targets to the HIV-positive MSM and the effect is not promising. Our study aims to provide Internet-based partner notification, along with a series of health services for HIV-negative MSM to protect them from HIV and other STDs.
METHODS


A pragmatic stepped wedge cluster randomized controlled trial design is used to evaluate the effectiveness of a new intervention paradigm, which aims to reduce HIV and other STDs incidences among MSM in China. Through integrating a mobile health (mHealth) service application (app) to the current HIV and other STDs prevention and control methods, the new paradigm provides partner notification of HIV, syphilis, hepatitis B, and hepatitis C statuses. A total of 6172 MSM in 16 districts of Beijing, China will be recruited and randomized to sequentially receive partner notification intervention through the app at 6-month intervals. The primary outcomes are HIV incidence and the additional cost of the intervention. The secondary outcomes include incidences of syphilis, hepatitis B, and hepatitis C, disease transmission social networks, testing adherence, knowledge of HIV and STDs control, health self-responsibility awareness, changes of high risk behaviors and other related outcomes. The generalized linear mixed models (GLMM) will be used to analyze the differences of outcomes in the control period and in the intervention period.
DISCUSSION


We expect that the HIV incidence will be significantly lower and the secondary outcomes will also be improved with providing health service of partner notification through mhealth intervention. The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04349748 . Registered on 16 April 2020.",2020,"The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
","['men who have sex with men (MSM) look for casual partners through online dating platforms in China', 'A total of 6172 MSM in 16 districts of Beijing, China']",[],"['HIV incidence and the additional cost of the intervention', 'incidences of syphilis, hepatitis B, and hepatitis C, disease transmission social networks, testing adherence, knowledge of HIV and STDs control, health self-responsibility awareness, changes of high risk behaviors and other related outcomes']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",6172.0,0.127014,"The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
","[{'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Hexuan', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'School of Public Health, Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Zuhong', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory for Bioelectronics, School of Biological Science and Medical Engineering, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'National Institute on Drug Dependence, Peking University, 38 Xueyuan Rd, Haidian District, Beijing, 100191, China. urchinjj@163.com.'}]",BMC public health,['10.1186/s12889-020-09162-x']
2630,32664946,Exercise as a diagnostic and therapeutic tool for preventing cardiovascular morbidity in breast cancer patients- the BReast cancer EXercise InTervention (BREXIT) trial protocol.,"BACKGROUND


Anthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC can reduce the proportion of BCa patients with functional disability (peak VO 2 , < 18 ml/kg/min), and 2) compare current standard-of-care for detecting cardiac dysfunction (resting left-ventricular ejection fraction assessed from 3-dimensional echocardiography) to measures of cardiac reserve (peak exercise cardiac output assessed from exercise cardiac magnetic resonance imaging) for predicting the development of functional disability 12-months following AC. Secondary aims are to assess the effects of ET on VO2peak, left ventricular morphology, vascular stiffness, cardiac biomarkers, body composition, bone mineral density, muscle strength, physical function, habitual physical activity, cognitive function, and multidimensional quality of life.
METHODS


One hundred women with early-stage BCa (40-75 years) scheduled for AC will be randomized to 12-months of structured exercise training (n = 50) or a usual care control group (n = 50). Participants will be assessed at baseline, 4-weeks following completion of AC (4-months) and at 12-months for all measures.
DISCUSSION


Women diagnosed with early-stage BCa have increased cardiac mortality. More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.
TRIAL REGISTRATION


Australia & New Zealand Clinical Trials Registry (ANZCTR), ID: 12617001408370 . Registered on 5th of October 2017.",2020,"More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.
","['early-stage breast cancer (BCa', 'One hundred women with early-stage BCa (40-75\u2009years) scheduled for AC', 'breast cancer patients- the BReast cancer', 'BCa patients with functional disability (peak VO 2 , <\u200918\u2009ml/kg/min), and 2']","['Anthracycline chemotherapy (AC', 'structured exercise training (n\u2009=\u200950) or a usual care control group', 'cardiac reserve (peak exercise cardiac output assessed from exercise cardiac magnetic resonance imaging', 'EXercise InTervention']","['cardiac mortality', 'cardiovascular morbidity', 'VO2peak, left ventricular morphology, vascular stiffness, cardiac biomarkers, body composition, bone mineral density, muscle strength, physical function, habitual physical activity, cognitive function, and multidimensional quality of life']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",100.0,0.304696,"More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.
","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Foulkes', 'Affiliation': 'Sports Cardiology Lab, Clinical Research Domain, Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Howden', 'Affiliation': 'Sports Cardiology Lab, Clinical Research Domain, Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Yoland', 'Initials': 'Y', 'LastName': 'Antill', 'Affiliation': 'Melbourne Cancer Care, Cabrini Health, Brighton, VIC, Australia.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Translational Breast Cancer Genomics Laboratory, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Salim', 'Affiliation': 'Department of Population Health, Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Haykowsky', 'Affiliation': 'Sports Cardiology Lab, Clinical Research Domain, Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute of Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Steve F', 'Initials': 'SF', 'LastName': 'Fraser', 'Affiliation': 'Institute of Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'La Gerche', 'Affiliation': 'Sports Cardiology Lab, Clinical Research Domain, Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC, 3004, Australia. Andre.LaGerche@baker.edu.au.'}]",BMC cancer,['10.1186/s12885-020-07123-6']
2631,32664948,"Electrocardiographic safety evaluation of extended artemether-lumefantrine treatment in patients with uncomplicated Plasmodium falciparum malaria in Bagamoyo District, Tanzania.","BACKGROUND


Extended artemisinin-based combination therapy (ACT) for treatment of uncomplicated Plasmodium falciparum malaria with already existing drug regimens, such as artemether-lumefantrine, might be effective in tackling the emerging ACT resistance. However, given the history of cardiotoxicity among anti-malarial drugs structurally similar to lumefantrine, the potential effect of extended artemether-lumefantrine treatment on the electrocardiographic (ECG) QTc interval is of high concern.
METHODS


Male and non-pregnant females aged 1-65 years, diagnosed with uncomplicated P. falciparum malaria in Bagamoyo district, Tanzania, were randomized into two arms. The intervention arm received an extended, i.e. 6-day, course of artemether-lumefantrine and an additional single low-dose primaquine (0.25 mg/kg) administered together with the last artemether-lumefantrine dose. The control arm received the standard weight-based 3-day course. ECGs were performed at day 0 and 4-5 h after the last dose at day 5. QT intervals were read manually using the tangent method and automatically. Bazett's (QTcB) and Fridericia's (QTcF) formulae were used for correction for heart rate. Descriptive statistics were used to calculate baseline characteristics and the number of supra-thresholds QTc intervals (QTc prolongation > 500, change in QTc interval (ΔQTc) > 60 ms). The mean change in QTc interval in and between the two arms was compared using the paired t-test and independent samples t-test, respectively.
RESULTS


A total of 195 patients were enrolled, 103 and 92 in the intervention and control arm, respectively. No patient experienced QTc intervals > 500 ms on day 5 by both formulae. Patients with ΔQTc > 60 ms, for QTcF were 6/103 (5.8%) vs 2/92 (2.2%) and for QTcB 2/103 (1.9%) vs 1/92 (1.1%) in the intervention and control arms, respectively. The mean difference in ΔQTc interval was statistically significant between the two arms with both correction formulae, 11.4 ms (95% CI 2.7-20.0, p = 0.010) and 13.4 ms (95% CI 5.3-21.5, p = 0.001), for QTcB and QTcF, respectively.
CONCLUSION


The extended 6-day course of artemether-lumefantrine did not reveal clinically relevant QTc prolonging effects. However, significant QTcF prolongation and presence of patients with supra-threshold QTc values observed in the intervention arm underscore the importance of further monitoring of QTc parameters in extended artemether-lumefantrine treatment. Trial registration ClinicalTrials.gov, NCT03241901. Registered July 27, 2017. https://clinicaltrials.gov/show/NCT03241901.",2020,The extended 6-day course of artemether-lumefantrine did not reveal clinically relevant QTc prolonging effects.,"['Male and non-pregnant females aged 1-65\xa0years, diagnosed with uncomplicated P. falciparum malaria in Bagamoyo district, Tanzania', 'patients with uncomplicated Plasmodium falciparum malaria in Bagamoyo District, Tanzania', 'A total of 195 patients were enrolled, 103 and 92 in the intervention and control arm, respectively', 'Patients with ΔQTc\u2009']","['extended artemether-lumefantrine treatment', 'lumefantrine and an additional single low-dose primaquine', 'Extended artemisinin-based combination therapy (ACT']","['Electrocardiographic safety evaluation', 'ΔQTc interval', 'mean change in QTc interval', 'number of supra-thresholds QTc intervals (QTc prolongation\u2009>\u2009500, change in QTc interval (ΔQTc', 'QTcF prolongation and presence of patients with supra-threshold QTc values', ""Bazett's (QTcB) and Fridericia's (QTcF) formulae""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0024535', 'cui_str': 'Falciparum malaria'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",195.0,0.117463,The extended 6-day course of artemether-lumefantrine did not reveal clinically relevant QTc prolonging effects.,"[{'ForeName': 'Lwidiko E', 'Initials': 'LE', 'LastName': 'Mhamilawa', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden. lwidiko.edward@kbh.uu.se.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Wikström', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Bruno P', 'Initials': 'BP', 'LastName': 'Mmbando', 'Affiliation': 'Tanga Centre, National Institute for Medical Research, Tanga, Tanzania.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Ngasala', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mårtensson', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden.""}]",Malaria journal,['10.1186/s12936-020-03309-2']
2632,32664997,Where is an emotion? Using targeted visceroception as a method of improving emotion regulation in healthy participants to inform suicide prevention initiatives: a randomised controlled trial.,"BACKGROUND


William James' 1884 paper ""What is an emotion?"" has generated much recent interest in affective science regarding somatic contributions to emotion. Studies of interoception (""sensing the physiological condition of the body"") suggest that sensing specific parts of the body contributes to the production of emotion, namely when sensing the viscera (i.e. ""visceroception"" of the heart, gut or lungs). Improved visceroception has, for instance, been linked to increased emotional intensity, suggesting a role for interoception in emotion regulation that may pertain specifically to visceral bodily locations. Thus, in addition to asking James' question, ""What is an emotion?"", we ask, ""Where is an emotion?"". Further, there is an evidence base pointing to the connections between emotion regulation and suicide, and between interoception and suicide. This is a preliminary trial investigating whether targeted interoception/visceroception improves emotion regulation. Ultimately, the overall project aims to inform suicide prevention efforts.
METHODS


The trial utilises a pre-test/post-test control group design, with two experimental groups undergoing visceroceptive interventions (focussing on areas pertaining to the gut or heart) and a control group. The interventions will run for 8 weeks. A spatial cueing task will measure reaction times to bodily changes relating to lower abdomen or chest focus. A stop/signal task will measure emotional inhibition, which is hypothesised to obscure awareness of active bodily locations. Visceroceptive ability will be tracked using a heartbeat estimation task, a water load test, and by self-report questionnaire. The sample will consist of healthcare professionals and healthcare students. Despite these being groups that represent a relatively high suicide risk among professional and student groups, all participants will be healthy, given the preliminary nature of this trial.
DISCUSSION


To our knowledge, this will be the first project to address whether emotional feeling presents as a localised bodily phenomenon and whether trained awareness of emotional localisation can improve emotion regulation. It will also be the first to investigate relationships between interoception and emotional inhibition (i.e. whether a sustained interoceptive practice leads to the disinhibition of bodily emotional sensations, which can positively contribute to emotion regulation). These empirical findings on emotion regulation from a healthy sample will be used to inform a desk-based enquiry into the role of embodied emotion in suicide prevention, which may make a significant contribution to a growing evidence base on interoception and suicide.
TRIAL REGISTRATION


ACTR N12619000324112 . Registered on 4 March 2019. Universal Trial Number (UTN): U1111-1221-0201.",2020,"Improved visceroception has, for instance, been linked to increased emotional intensity, suggesting a role for interoception in emotion regulation that may pertain specifically to visceral bodily locations.","['healthy participants', ""William James' 1884 paper ""]",['visceroceptive interventions (focussing on areas pertaining to the gut or heart) and a control group'],['emotion regulation'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030351', 'cui_str': 'Paper'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0367685,"Improved visceroception has, for instance, been linked to increased emotional intensity, suggesting a role for interoception in emotion regulation that may pertain specifically to visceral bodily locations.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Davey', 'Affiliation': 'Suicide and Mental Health Research Group, University of Otago, Wellington, PO Box 7343, Wellington, Newtown, 6242, New Zealand. davst397@student.otago.ac.nz.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Bell', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Jamin', 'Initials': 'J', 'LastName': 'Halberstadt', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Collings', 'Affiliation': 'Suicide and Mental Health Research Group, University of Otago, Wellington, New Zealand.'}]",Trials,['10.1186/s13063-020-04479-9']
2633,32665001,Correction to: ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['frontline healthcare workers'],['hydroxychloroquine'],[],"[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.130802,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'McEniery', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fisk', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK. mf503@medschl.cam.ac.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miles', 'Affiliation': 'Cambridge University Hospitals NHS, Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Kaloyirou', 'Affiliation': 'Cambridge University Hospitals NHS, Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hubsch', 'Affiliation': 'Cambridge University Hospitals NHS, Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Cambridge University Hospitals NHS, Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}]",Trials,['10.1186/s13063-020-04578-7']
2634,32665006,Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients.,"BACKGROUND


The standard therapy for patients suffering from sensorineural hearing loss is cochlear implantation. The insertion of the electrode array into the cochlea, with potential mechanical trauma and the presence of this foreign body inside the cochlea, may lead to free radical formation and reduced blood perfusion of the cochlea which can result in a loss of residual hearing. Studies have suggested that a particular combination of the antioxidants vitamins A, C and E as well as the vasodilator magnesium (together: ACEMg) may protect the residual hearing.
METHODS


The potential protective effect of ACEMg on residual hearing preservation in cochlear implant (CI) patients was investigated in a single-centre, randomized, placebo-controlled, double-blind phase II clinical trial. CI candidates with some residual hearing in low frequencies receiving MED-EL implants of different FLEX electrode array lengths were treated with ACEMg tablets or placebo respectively 2 days preoperatively and up to 3 months postoperatively. The study objective was to demonstrate that ACEMg is more efficacious than placebo in preserving residual hearing during cochlear implantation by comparing the hearing loss (change in hearing thresholds at 500 Hz from baseline) 3 months after the first fitting between the two treatment groups and to investigate the treatments' safety.
RESULTS


Fifty-one patients were included in the study, which had to be terminated before the recruitment goal was reached because of IMP-resupply mismanagement of one partner. In the intention-to-treat population, 25 patients were treated with ACEMg and 24 patients with placebo. The mean hearing loss at 500 Hz was (± 15.84) 30.21 dB (placebo) or (± 17.56) 26.00 dB (ACEMg) 3 months after the initial fitting. Adjusting the postoperative hearing loss for the baseline residual hearing, planned electrode length and surgeon results in 8.01 dB reduced hearing loss in ACEMg-treated patients compared to placebo-treated ones. The safety analysis revealed that ACEMg was generally well-tolerated with adverse event frequencies below the placebo level.
CONCLUSION


This is the first clinical trial investigating a drug effect on residual hearing in CI patients. These first-in-man data may suggest that a perioperative oral administration of ACEMg is safe and may provide protection of residual hearing in CI patients.
TRIAL REGISTRATION


EU Clinical Trial Register No. 2012-005002-22 . Registered on 6 December 2013.
FUNDING


European Commission FP7-HEALTH-2012-INNOVATION-2.",2020,The mean hearing loss at 500 Hz was (± 15.84) 30.21 ,"['Fifty-one patients', 'cochlear implant patients', 'CI patients', 'patients suffering from sensorineural hearing loss is cochlear implantation', 'cochlear implant (CI) patients']","['placebo', 'ACEMg', 'ACEMg tablets or placebo', 'antioxidants and a vasodilator', 'dB (placebo) or (±\u200917.56']","['residual hearing', 'residual hearing preservation', 'overall safety and residual hearing preservation', 'mean hearing loss', 'hearing loss', 'postoperative hearing loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",51.0,0.361929,The mean hearing loss at 500 Hz was (± 15.84) 30.21 ,"[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Scheper', 'Affiliation': 'Department of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. scheper.verena@mh-hannover.de.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schmidtheisler', 'Affiliation': 'Department of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lasch', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'von der Leyen', 'Affiliation': 'Hannover Clinical Trial Center, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schwieger', 'Affiliation': 'Department of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Büchner', 'Affiliation': 'Department of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Lesinski-Schiedat', 'Affiliation': 'Department of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lenarz', 'Affiliation': 'Department of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}]",Trials,['10.1186/s13063-020-04522-9']
2635,32665034,"Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study.","BACKGROUND


Delirium is an acute status of brain dysfunction that commonly occurs in patients who have undergone cardiac surgery, and increases morbidity and mortality. It is associated with risk factors, such as older age, use of narcotics, cardiopulmonary bypass, and hypothermia. Dexmedetomidine infusion might exert a neuroprotective effect. However, the effect of perioperative administration of dexmedetomidine on the incidence of postoperative delirium (POD) in patients undergoing cardiac or non-cardiac surgery is yet controversial. The present study aimed to reveal the effect of intraoperative dexmedetomidine administration on the incidence of delirium in adult patients following cardiac surgery.
METHODS


This single-center, randomized, double-blinded, and placebo-controlled trial consisted of 652 patients randomly divided into two groups: dexmedetomidine and placebo. 0.6 μg/kg dexmedetomidine will be infused 10 min after central vein catheterization, followed by a continuous infusion at a speed of 0.4 μg/kg/h until the end of surgery in the dexmedetomidine group, while normal saline will be administered at the same rate in the placebo group. The primary outcome is the incidence of POD during the first 7 days post-surgery. The secondary outcomes include duration of mechanical ventilation after surgery, duration of stay in the intensive care unit and the hospital after surgery, incidence of hypotension during or after dexmedetomidine infusion, acute kidney injury and sudden arrhythmia during the hospital stay postoperatively, and all-cause mortality in 30 and 90 days after surgery, respectively.
DISCUSSION


This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences Fuwai Hospital on 6 March 2019 (2019-1180). The results will be disseminated at academic conferences and submitted to peer-reviewed publications. Either positive or negative results will provide guidance for clinical practice.
TRIAL REGISTRATION


The Chinese Clinical Trial Registry ( http://www.chictr.org.cn ) ChiCTR1900022583. Registered on 17 April 2019.",2020,"It is associated with risk factors, such as older age, use of narcotics, cardiopulmonary bypass, and hypothermia.","['patients undergoing cardiac or non-cardiac surgery', 'adult patients following cardiac surgery', 'adult patients following cardiac valve surgery', 'patients who have undergone cardiac surgery', 'Chinese Academy of Medical Sciences Fuwai Hospital on 6 March 2019 (2019-1180', '652 patients randomly divided into two groups']","['intraoperative dexmedetomidine infusion', 'Dexmedetomidine', 'dexmedetomidine and placebo', 'dexmedetomidine', 'intraoperative dexmedetomidine', 'placebo']","['incidence of POD during the first 7\u2009days post-surgery', 'morbidity and mortality', 'duration of mechanical ventilation after surgery, duration of stay in the intensive care unit and the hospital after surgery, incidence of hypotension during or after dexmedetomidine infusion, acute kidney injury and sudden arrhythmia during the hospital stay postoperatively, and all-cause mortality', 'postoperative delirium (POD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",652.0,0.710088,"It is associated with risk factors, such as older age, use of narcotics, cardiopulmonary bypass, and hypothermia.","[{'ForeName': 'Hong-Bai', 'Initials': 'HB', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, No. 6, 7 Branch Road, Panxi, Jiangbei District, Chongqing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, No. 167 North Lishi Road, Xicheng District, Beijing, China. fuwaiys@126.com.'}, {'ForeName': 'Fu-Xia', 'Initials': 'FX', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}, {'ForeName': 'Qi-Peng', 'Initials': 'QP', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}]",Trials,['10.1186/s13063-020-04574-x']
2636,32665035,"Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design.","BACKGROUND


Despite evidence of a quite large beneficial effect of endovascular treatment (EVT) for ischemic stroke caused by anterior circulation large vessel occlusion, many patients do not recover even after complete recanalization. To some extent, this may be attributable to incomplete microvascular reperfusion, which can possibly be improved by antiplatelet agents and heparin. It is unknown whether periprocedural antithrombotic medication in patients treated with EVT improves functional outcome. The aim of this study is to assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin (UFH), alone, or in combination, given to patients with an ischemic stroke caused by an intracranial large vessel occlusion in the anterior circulation during EVT.
METHODS


MR CLEAN-MED is a multicenter phase III trial with a prospective, 2 × 3 factorial randomized, open label, blinded end-point (PROBE) design, which aims to enroll 1500 patients. The trial is designed to evaluate the effect of intravenous ASA (300 mg), UFH (low or moderate dose), both or neither as adjunctive therapy to EVT. We enroll adult patients with a clinical diagnosis of stroke (NIHSS ≥ 2) and with a confirmed intracranial large vessel occlusion in the anterior circulation on CTA or MRA, when EVT within 6 h from symptom onset is indicated and possible. The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Treatment effect on the mRS will be estimated with ordinal logistic regression analysis, with adjustment for main prognostic variables. Secondary outcomes include stroke severity measured with the NIHSS at 24 h and at 5-7 days, follow-up infarct volume, symptomatic intracranial hemorrhage (sICH), and mortality.
DISCUSSION


Clinical equipoise exists whether antithrombotic medication should be administered during EVT for a large vessel occlusion, as ASA and/or UFH may improve functional outcome, but might also lead to an increased risk of sICH. When one or both of the study treatments show the anticipated effect on outcome, we will be able to improve outcome of patients treated with EVT by 5%. This amounts to more than 50 patients annually in the Netherlands, more than 1800 in Europe, and more than 1300 in the USA.
TRIAL REGISTRATION


ISRCT, ISRCTN76741621 . Dec 6, 2017.",2020,"BACKGROUND


Despite evidence of a quite large beneficial effect of endovascular treatment (EVT) for ischemic stroke caused by anterior circulation large vessel occlusion, many patients do not recover even after complete recanalization.","['enroll 1500 patients', 'adult patients with a clinical diagnosis of stroke (NIHSS ≥\u20092) and with a confirmed intracranial large vessel occlusion in the anterior circulation on CTA or MRA, when EVT within 6\u2009h from symptom onset is indicated and possible', 'patients treated with', '50 patients annually in the Netherlands, more than 1800 in Europe, and more than 1300 in the USA', 'acute ischemic stroke', 'patients with an ischemic stroke caused by an intracranial large vessel occlusion in the anterior circulation during EVT']","['endovascular treatment', 'periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED', 'acetylsalicylic acid (ASA) and unfractionated heparin (UFH', 'EVT', 'endovascular treatment (EVT', 'intravenous ASA']","['score on the modified Rankin Scale (mRS', 'functional outcome', 'stroke severity measured with the NIHSS at 24\u2009h and at 5-7\u2009days, follow-up infarct volume, symptomatic intracranial hemorrhage (sICH), and mortality']","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.172802,"BACKGROUND


Despite evidence of a quite large beneficial effect of endovascular treatment (EVT) for ischemic stroke caused by anterior circulation large vessel occlusion, many patients do not recover even after complete recanalization.","[{'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Chalos', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'A van de Graaf', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands. b.roozenbeek@erasmusmc.nl.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'C G M van Es', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'M den Hertog', 'Affiliation': 'Department of Neurology, Isala, Zwolle, The Netherlands.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Staals', 'Affiliation': 'Department of Neurology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'van Dijk', 'Affiliation': 'Department of Radiology & Nuclear Medicine, HagaZiekenhuis, Radiology, Den Haag, The Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'F M Jenniskens', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'J van Oostenbrugge', 'Affiliation': 'Department of Neurology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'H van Zwam', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Yvo', 'Initials': 'Y', 'LastName': 'B W E M Roos', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'B L M Majoie', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'F Lingsma', 'Affiliation': 'Department of Public Health, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'W J Dippel', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04514-9']
2637,32665120,Evaluation of the wear of glazed and polished zirconia crowns and the opposing natural teeth: A clinical pilot study.,"STATEMENT OF PROBLEM


Clinical studies on the wear properties of different zirconia surfaces are lacking. Selecting a surface that causes and undergoes minimal wear will help improve clinical outcomes.
PURPOSE


The purpose of this clinical study was to evaluate and compare the wear over 1 year use of glazed zirconia (GZ) and polished zirconia (PZ) crowns opposing natural enamel and the wear of natural enamel opposing PZ and GZ crowns.
MATERIAL AND METHODS


This prospective, split mouth, randomized clinical trial included 14 participants requiring complete coverage crowns on first molars, bilaterally, in a completely dentate mandibular arch. GZ and PZ crowns were cemented according to a randomization chart. Polyvinyl siloxane impressions were made immediately and 1 year after the cementation of the crowns. The respective casts were scanned by using a 3D scanner and a software program to measure the amount of linear wear of zirconia crowns and opposing natural teeth. Wear was observed in 8 groups: PZ crowns, GZ crowns, natural enamel opposing natural enamel in the molar and premolar regions (NE-M and NE-PM), natural enamel opposing PZ crowns in the molar region (NE-PZ-M), natural enamel opposing GZ crowns in the molar region (NE-GZ-M), natural enamel opposing PZ crowns in the premolar region (NE-PZ-PM), and natural enamel opposing GZ crowns in the premolar region (NE-GZ-PM). A descriptive analysis was followed by comparison between groups by using a repeated-measure ANOVA with post hoc adjustments (α=.05).
RESULTS


The mean wear (μm) observed was as follows (in ascending order): PZ crowns (13 ±3), NE-PM (13 ±1), GZ crowns (27 ±9), NE-M (34 ±3), NE-PZ-PM (44 ±18), NE-PZ-M (63 ±22), NE-GZ-PM (69 ±21), NE-GZ-M (113 ±33). Wear of GZ and PZ crowns was less than wear of NE-M. The difference was statistically significant when comparing PZ with NE-M (P<.001, CI=-17 to -24). Wear of NE-GZ-M and NE-PZ-M was higher than wear of NE-M, with a statistically significant difference (P<.001, CI=-49 to -107 and P =.004, CI=-8 to -49, respectively). Wear of NE-GZ-M was more than that of NE-PZ-M, and the difference was statistically significant (P<.001, CI=-68 to -32). Wear of NE-PZ-PM and NE-GZ-PM was also more than the wear of NE-PM, and the difference was statistically significant (P<.001, CI=-17 to -43 and P<.001, CI=-39 to -70).
CONCLUSIONS


PZ and GZ crowns wear substantially with time, with lesser wear observed in PZ crowns. PZ and GZ crowns also cause more wear in opposing natural enamel than natural enamel antagonists, with the highest wear caused by GZ crowns.",2020,"The difference was statistically significant when comparing PZ with NE-M (P<.001, CI=-17 to -24).","['8 groups: PZ crowns, GZ crowns, natural enamel opposing natural enamel in the molar and premolar regions (NE-M and NE-PM), natural enamel opposing PZ crowns in the molar region (NE-PZ-M), natural enamel opposing GZ crowns in the molar region (NE-GZ-M), natural enamel opposing PZ crowns in the premolar region (NE-PZ-PM), and natural enamel opposing GZ crowns in the premolar region (NE-GZ-PM', 'wear of glazed and polished zirconia crowns and the opposing natural teeth', '14 participants requiring complete coverage crowns on first molars, bilaterally, in a completely dentate mandibular arch']","['GZ and PZ crowns', 'Polyvinyl siloxane impressions', 'PZ crowns (13 ±3), NE-PM (13 ±1), GZ crowns (27 ±9), NE-M (34 ±3), NE-PZ-PM (44 ±18), NE-PZ-M (63 ±22), NE-GZ-PM (69 ±21), NE-GZ-M', 'glazed zirconia (GZ) and polished zirconia (PZ) crowns', 'PZ and GZ crowns']","['Wear of NE-GZ-M and NE-PZ-M', 'mean wear (μm']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0231063', 'cui_str': 'First branchial arch structure'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0078267', 'cui_str': 'vinyl polysiloxane'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",14.0,0.0371291,"The difference was statistically significant when comparing PZ with NE-M (P<.001, CI=-17 to -24).","[{'ForeName': 'Uvashri', 'Initials': 'U', 'LastName': 'Selvaraj', 'Affiliation': 'Junior Resident, Department of Prosthodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dheeraj Kumar', 'Initials': 'DK', 'LastName': 'Koli', 'Affiliation': 'Associate Professor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Professor and Head, Department of Prosthodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India. Electronic address: jainveena1@gmail.com.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Nanda', 'Affiliation': 'Assistant Professor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.04.007']
2638,32665162,Differences in pharmacological property between combined therapy of the vasopressin V2-receptor antagonist tolvaptan plus furosemide and monotherapy of furosemide in patients with hospitalized heart failure.,"BACKGROUND


Tolvaptan has been shown to improve congestion in heart failure patients. The purpose of this study was to evaluate the pharmacology and clinical efficacy of combined tolvaptan and furosemide therapy.
METHODS


This study included 40 patients with systemic volume overload who were hospitalized for heart failure. Patients who showed no improvement in the condition after receiving 20 mg intravenous furosemide were included and were randomly selected to receive tolvaptan as an add-on to furosemide or to receive an increased dose of furosemide. We evaluated the bioelectrical impedance analyzer parameters, the parameters of the inferior vena cava using echocardiography, vital signs, body weight, urine output, and laboratory data for 5 days.
RESULTS


In the changes from baseline between intracellular water volume (ICW) and extracellular water volume (ECW) after additional use of tolvaptan or furosemide from Day 1 to Day 5, there were no significant differences observed between ICW and ECW over 5 days in the tolvaptan + furosemide group, although differences were found in the furosemide group from Day 2 onward. Changes in the respiratory collapse of inferior vena cava increased significantly, and systolic blood pressure decreased significantly only in the furosemide group.
CONCLUSIONS


The present study clearly demonstrates that combined therapy with tolvaptan and furosemide removed excess ICW and ECW to an equal extent, while furosemide alone primarily removed ECW, including intravascular water.",2020,"Changes in the respiratory collapse of inferior vena cava increased significantly, and systolic blood pressure decreased significantly only in the furosemide group.
","['heart failure patients', 'Patients who showed no improvement in the condition after receiving 20\u2009mg intravenous', 'patients with hospitalized heart failure', '40 patients with systemic volume overload who were hospitalized for heart failure']","['combined tolvaptan and furosemide therapy', 'furosemide', 'furosemide or to receive an increased dose of furosemide', 'tolvaptan', 'tolvaptan and furosemide']","['bioelectrical impedance analyzer parameters, the parameters of the inferior vena cava using echocardiography, vital signs, body weight, urine output, and laboratory data for 5 days', 'respiratory collapse of inferior vena cava', 'intracellular water volume (ICW) and extracellular water volume (ECW', 'systolic blood pressure', 'ICW and ECW']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",40.0,0.0298008,"Changes in the respiratory collapse of inferior vena cava increased significantly, and systolic blood pressure decreased significantly only in the furosemide group.
","[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takagi', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiovascular Medicine, Kawaguchi Cardiovascular and Respiratory Hospital, Kawaguchi, Japan. Electronic address: n.sato@kheartlung.jp.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Hayano', 'Initials': 'H', 'LastName': 'Iha', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Nohara', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Ohkuma', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Mitsuishi', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ishizuka', 'Affiliation': 'Department of Cardiovascular Medicine, Kawaguchi Cardiovascular and Respiratory Hospital, Kawaguchi, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Shigihara', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nakama', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Cardiovascular Medicine, Kawaguchi Cardiovascular and Respiratory Hospital, Kawaguchi, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Omote', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Arifumi', 'Initials': 'A', 'LastName': 'Kikuchi', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Eisei', 'Initials': 'E', 'LastName': 'Yamamoto', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Amitani', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Maruyama', 'Affiliation': 'Department of Cardiovascular Surgery, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Imura', 'Affiliation': 'Department of Cardiovascular Surgery, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.05.012']
2639,32665179,"Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study.","OBJECTIVES


The postoperative analgesic efficacy of transversus thoracic muscle plane block (TTMPB) has not yet been evaluated sufficiently. This randomized controlled study evaluated the effect of TTMPB on postoperative opioid consumption in patients undergoing cardiac surgery.
DESIGN


Prospective, randomized, double-blind study.
SETTINGS


Single institution, academic university hospital.
PARTICIPANTS


Forty-eight adult patients having cardiac surgery with median sternotomy.
INTERVENTIONS


Patients were randomly assigned to receive preoperative ultrasound-guided TTMPB with either 20 mL of 0.25% bupivacaine or saline bilaterally. Postoperative analgesia was administered intravenously in the 2 groups 4 times a day with 1000 mg of paracetamol and patient-controlled analgesia with fentanyl.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was opioid consumption in the first 24 hours. Secondary outcomes included postoperative pain scores, first analgesic requirement time, rescue analgesia, intensive care discharge time, and side effects. Compared with the control group (median 465 µg, interquartile range 415-585), the transversus thoracic muscle plane (TTMP) group (median 255 µg, interquartile range 235-305) had reduced postoperative 24-hour opioid consumption (p < 0.001). Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001). Compared with the TTMP group, the proportion of postoperative nausea and pruritus was statistically higher in the control group (p < 0.001).
CONCLUSIONS


A single preoperative TTMPB provided effective analgesia and decreased opioid requirements in patients undergoing cardiac surgery.",2020,Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001).,"['Single institution, academic university hospital', 'patients undergoing cardiac surgery', 'Forty-eight adult patients having cardiac surgery with median sternotomy']","['TTMP', 'paracetamol and patient-controlled analgesia with fentanyl', 'preoperative ultrasound-guided TTMPB with either 20 mL of 0.25% bupivacaine or saline bilaterally', 'transversus thoracic muscle plane block (TTMPB', 'TTMPB', 'Ultrasound-Guided Transversus Thoracic Muscle Plane Block']","['transversus thoracic muscle plane', 'postoperative opioid consumption', 'postoperative pain scores, first analgesic requirement time, rescue analgesia, intensive care discharge time, and side effects', 'postoperative 24-hour opioid consumption', 'opioid consumption', 'Postoperative Opioid Consumption', 'proportion of postoperative nausea and pruritus', 'postoperative analgesic efficacy', 'Pain scores', 'opioid requirements']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.568675,Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001).,"[{'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey. Electronic address: aliahiskalioglu@hotmail.com.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ibrahim Hakki', 'Initials': 'IH', 'LastName': 'Tor', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Borulu', 'Affiliation': 'Department of Cardiovascular Surgery, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ozlem Dilara', 'Initials': 'OD', 'LastName': 'Erguney', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Dogan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.06.044']
2640,32665197,Sutureless versus interrupted sutures techniques for neonatal circumcision; a randomized clinical trial.,"INTRODUCTION


and objective: Male circumcision is a common procedure all over the world; in Saudi Arabia, circumcision is the most frequent elective surgical procedure performed on males. The use of sutures for neonatal circumcision may decrease bleeding; however, it may lead to skin sinus formation. The objective of this study was to compare the sutureless to the interrupted sutures technique for neonatal circumcision with Gamco clamp.
PATIENTS AND METHODS


We performed a randomized controlled clinical trial between 2017 and 2018. The study included 182 newborns assigned into two groups. Group 1 (n = 94) included neonates who had sutureless circumcision, and group 2 (n = 89) included neonates who underwent circumcision using interrupted absorbable 6/0 sutures. Study endpoints were bleeding, wound gaping, skin tunneling or sinus, and cyst formation.
RESULTS


There was no significant difference in patients' age and weight between groups. The procedure was significantly longer in group 2 (12.24 ± 2.17 vs. 6.54 ± 1.42 min; p < 0.001). There was no difference in bleeding between both groups (4 (4.26%) vs. 2 (2.27%) in groups 1 and 2, respectively, p = 0.683). Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
DISCUSSION


Circumcision can be performed with several techniques, and the superiority of one approach over the other is still debated. Many surgeons use interrupted sutures to oppose the skin edges, and in some reports, tissue glue was used for skin edges re-approximation with acceptable cosmetic results. In our study, the mean time taken for sutureless circumcision was about 7 min, and for the suture circumcision, it took around 11 min. In addition, the formation of a skin tunnel or sinuses rate was high despite the use of very thin sutures.
CONCLUSION


Male circumcision is a common and safe technique with minor and treatable complications. Risks of bleeding and sinus track formation are low with the sutureless method. The sutureless technique is recommended after Gamco circumcision as the standard technique for male circumcision in the newborn.",2020,"Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
","['182 newborns assigned into two groups', '2017 and 2018', 'Group 1 (n\xa0=\xa094) included neonates who had sutureless circumcision, and group 2 (n\xa0=\xa089) included neonates who underwent']","['Sutureless versus interrupted sutures techniques', 'circumcision using interrupted absorbable 6/0 sutures']","['formation of a skin tunnel or sinuses rate', 'Risks of bleeding and sinus track formation', 'mean time taken for sutureless circumcision', 'bleeding, wound gaping, skin tunneling or sinus, and cyst formation', 'skin sinus formation', 'bleeding', 'Cyst formation']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0423772', 'cui_str': 'External fistula'}]",182.0,0.0270562,"Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Bawazir', 'Affiliation': 'Department of Surgery, Faculty of medicine Umm Al-Qura University, Makkah& King Faisal Specialist Hospital & Research Centre, Saudi Arabia. Electronic address: obawazir@yahoo.com.'}, {'ForeName': 'Abdulaziz M', 'Initials': 'AM', 'LastName': 'Banaja', 'Affiliation': 'Department of Surgery, Faculty of medicine Umm Al-Qura University, Makkah& King Faisal Specialist Hospital & Research Centre, Saudi Arabia. Electronic address: Azizbanaja@hotmail.com.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.06.025']
2641,32665211,Comparison of Hiraoka's Transurethral Detachment Prostatectomy and Transurethral Resection of the Prostate Effects on Postoperative Erectile Function in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Study.,"BACKGROUND


Currently, no study has focused on the postoperative erectile function in patients with benign prostatic hyperplasia (BPH) by comparing Hiraoka's transurethral detachment of prostate (TUDP) and transurethral resection of prostate (TURP).
AIM


To compare the effects of Hiraoka's TUDP and TURP on postoperative erectile function in patients with BPH after long-term follow-up.
METHODS


A total of 104 consecutive patients with BPH treated in our hospital between September 2018 and February 2019 were included in the study. All patients who met the inclusion criteria were randomly divided into the Hiraoka's TUDP (n = 52) and TURP (n = 52) groups. Patient baseline data were collected. The international index of erectile function (IIEF-5), minimal clinically important difference (MCID), and quality of life scale (QOLS) were used to evaluate erectile function and quality of life 3, 6, and 12 months after surgery. Primary study endpoints were IIEF-5 and MCID. Secondary study endpoints were QOLS and independent prognostic factors for MCID.
OUTCOMES


Hiraoka's TUDP experienced greater improvement in postoperative IIEF5 scores than patients who underwent TURP.
RESULTS


Patients in the Hiraoka's TUDP group had significantly higher mean IIEF-5 scores than those in the TURP group 6 and 12 months after surgery (6 months: 18.9 vs 14.8, P < .001; 12 months: 18.1 vs 15.7, P < .001). The percentages of patients in the TUDP group who achieved an MCID were 88.5% and 80.8%, compared to 30.8% and 46.2% in the TURP group (P < .001 for both), 6 and 12 months after the operation, respectively. Patients in the TUDP group had lower QOLS scores than those in the TURP group after the surgery. The surgical method was an independent prognostic factor for MCID (odds ratio = 0.218).
CLINICAL IMPLICATIONS


Until now, no study has focused on the postoperative erectile function in patients with BPH by comparing Hiraoka's TUDP and TURP. Our study addressed this issue, which can add a new paradigm in the management to BPH.
STRENGTH & LIMITATIONS


The comparison between Hiraoka's TUDP and TURP using a statistically appropriate, adequately powered methodology is the strength of the study. The single center and less participants are the limitations of the study. We believe that multicenter and large-sample studies are needed to further verify these study conclusions.
CONCLUSIONS


Among similar cohorts of patients with BPH who underwent TUDP and TURP, patients who underwent Hiraoka's TUDP experienced greater improvement in postoperative IIEF5 scores than patients who underwent TURP, while improvement in IPSS was similar among both groups. Pan C, Zhan Y, Zhao Y, et al. Comparison of Hiraoka's Transurethral Detachment Prostatectomy and Transurethral Resection of the Prostate Effects on Postoperative Erectile Function in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Study. J Sex Med 2020;XX:XXX-XXX.",2020,"OUTCOMES


Hiraoka's TUDP experienced greater improvement in postoperative IIEF5 scores than patients who underwent TURP.
","['104 consecutive patients with BPH treated in our hospital between September 2018 and February 2019 were included in the study', ""patients with BPH by comparing Hiraoka's TUDP and TURP"", 'patients with BPH after long-term follow-up', 'Patients With Benign Prostatic Hyperplasia', 'patients with benign prostatic hyperplasia (BPH', 'n\xa0=\xa052', 'All patients who met the inclusion criteria']","['TURP', 'TUDP', ""Hiraoka's TUDP and TURP"", ""Hiraoka's Transurethral Detachment Prostatectomy and Transurethral Resection"", ""Hiraoka's transurethral detachment of prostate (TUDP) and transurethral resection of prostate (TURP"", ""Hiraoka's TUDP"", 'TUDP and TURP']","['Postoperative Erectile Function', 'QOLS scores', 'mean IIEF-5 scores', 'MCID', 'QOLS and independent prognostic factors for MCID', 'IIEF-5 and MCID', 'postoperative IIEF5 scores', 'postoperative erectile function', 'international index of erectile function (IIEF-5), minimal clinically important difference (MCID), and quality of life scale (QOLS', 'IPSS']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}]",104.0,0.0320068,"OUTCOMES


Hiraoka's TUDP experienced greater improvement in postoperative IIEF5 scores than patients who underwent TURP.
","[{'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yunhong', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Department of Urology, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yueyang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Library, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Shengjing Hospital of China Medical University, Shenyang, China. Electronic address: bais@sj-hospital.org.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Department of Urology, Shengjing Hospital of China Medical University, Shenyang, China. Electronic address: baisongcmu81@163.com.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.06.001']
2642,32665218,"Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial.","OBJECTIVE


To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.
DESIGN


Pragmatic, blinded randomized controlled trial.
SETTING


Multidisciplinary hernia clinics in Houston, USA.
PARTICIPANTS


124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.
INTERVENTIONS


Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).
MAIN OUTCOME MEASURES


The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat.
RESULTS


Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0  v  0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141  v  77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125)  v  $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair.
CONCLUSION


This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03490266.",2020,"However, robotic repair had longer operative duration (141  v  77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125)  v  $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004).","['patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair', '124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019', 'Multidisciplinary hernia clinics in Houston, USA', 'n=59']","['laparoscopic ventral hernia repair', 'Robotic versus laparoscopic ventral hernia repair', 'robotic ventral hernia repair', 'Robotic ventral hernia repair', 'laparoscopic repair', 'robotic and laparoscopic ventral hernia repair']","['abdominal wall quality of life', 'healthcare costs', 'emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective', 'operative duration and healthcare costs', 'operative duration', 'number of days in hospital within 90 days after surgery', 'emergency department visits, wound complications, hernia recurrence, or reoperation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0192579', 'cui_str': 'Incision of intestine'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.631683,"However, robotic repair had longer operative duration (141  v  77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125)  v  $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004).","[{'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA oscarolavarria@hotmail.com.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Shinil K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX, USA.'}, {'ForeName': 'Elenir B', 'Initials': 'EB', 'LastName': 'Avritscher', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX, USA.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Loor', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m2457']
2643,32665265,"Familiarity with the clinical environment, achieved by priming, improves time to antibiotic administration in a simulated paediatric sepsis scenario: a randomised control trial.","AIM


The early administration of antibiotics in sepsis reduces mortality and improves outcomes. This randomised control trial evaluated the effect of environmental priming (EP) on healthcare student performance in a simulated paediatric sepsis scenario.
METHODS


Medical and nursing students were randomised into primed and unprimed groups. Primed groups received both direct and virtual priming. Each group completed a standardised simulated sepsis scenario. Time to achieve five key clinical interventions was recorded. Mini focus groups were conducted to explore perceptions of EP.
RESULTS


There were 26 primed and 26 unprimed groups. The primed students were quicker to complete all five interventions and statistically significantly quicker to achieving intravenous (IV) access (median 350 s vs 373 s, p=0.02), administering IV antibiotics (median 648 s vs 760 s, p=0.045) and seeking senior help (median 703 s vs 780 s, p=0.02). Primed students did not feel that they had gained any specific advantage from being primed.
CONCLUSIONS


EP can improve clinical performance. Implications for practice include incorporating EP of key clinical areas into local induction, standardisation of resuscitation areas and regular use of in situ simulation.",2020,"The primed students were quicker to complete all five interventions and statistically significantly quicker to achieving intravenous (IV) access (median 350 s vs 373 s, p=0.02), administering IV antibiotics (median 648 s vs 760 s, p=0.045) and seeking senior help (median 703 s vs 780 s, p=0.02).",['Medical and nursing students'],['environmental priming (EP'],"['quicker to achieving intravenous (IV) access', 'healthcare student performance', 'clinical performance']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0731549,"The primed students were quicker to complete all five interventions and statistically significantly quicker to achieving intravenous (IV) access (median 350 s vs 373 s, p=0.02), administering IV antibiotics (median 648 s vs 760 s, p=0.045) and seeking senior help (median 703 s vs 780 s, p=0.02).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'McNaughten', 'Affiliation': 'Paediatrics, Antrim Area Hospital, Antrim, UK bmcnaughten095@hotmail.com.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Storey', 'Affiliation': 'Department of Psychology, School of Social Sciences, Birmingham City University, Birmingham, West Midlands, UK.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Corkin', 'Affiliation': ""School of Nursing, Queen's University Belfast, Faculty of Medicine Health and Life Sciences, Belfast, UK.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cardwell', 'Affiliation': ""School of Nursing, Queen's University Belfast, Faculty of Medicine Health and Life Sciences, Belfast, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Paediatics, Royal Belfast Hospital for Sick Children, Belfast, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bourke', 'Affiliation': 'Paediatics, Royal Belfast Hospital for Sick Children, Belfast, UK.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': ""O'Donoghue"", 'Affiliation': 'Paediatics, Royal Belfast Hospital for Sick Children, Belfast, UK.'}]",Archives of disease in childhood,['10.1136/archdischild-2020-318904']
2644,32665311,"Buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma: a phase Ib/II, open-label, multicentre, randomised study.","BACKGROUND


Glioblastoma relapse is associated with activation of phosphatidylinositol 3-kinase (PI3K) signalling pathway. In preclinical studies, the pan-PI3K inhibitor buparlisib showed antitumour activity in glioma models.
METHODS


This was a two-part, multicentre, phase Ib/II study in patients with recurrent glioblastoma pretreated with radiotherapy and temozolomide standard of care. Patients received buparlisib (80 mg or 100 mg once daily) plus carboplatin (area under the curve (AUC)=5 every 3 weeks), or buparlisib (60 mg once daily) plus lomustine (100 mg/m 2  every 6 weeks). The primary endpoint was to determine the maximum tolerable dose (MTD) and/or recommended phase II dose of buparlisib plus carboplatin or lomustine.
RESULTS


Between 28 February 2014 and 7 July 2016, 35 patients were enrolled and treated with buparlisib plus carboplatin (n=17; buparlisib (80 mg) plus carboplatin, n=3; and buparlisib (100 mg) plus carboplatin, n=14), or buparlisib (60 mg) plus lomustine (n=18). The MTD of buparlisib was determined to be 100 mg per day in combination with carboplatin at an AUC of 5 every 3 weeks. The MTD of buparlisib in combination with lomustine could not be determined as it did not satisfy the MTD criteria per the Bayesian logistic regression model.
CONCLUSION


The overall safety profile of buparlisib remained unchanged, and no new or unexpected safety findings were reported in this study. Preliminary assessment for both combinations did not demonstrate sufficient antitumour activity compared with historical data on single-agent carboplatin or lomustine.
TRIAL REGISTRATION NUMBER


NCT01934361.",2020,"The overall safety profile of buparlisib remained unchanged, and no new or unexpected safety findings were reported in this study.","['patients with recurrent glioblastoma', 'patients with recurrent glioblastoma pretreated with', 'Between 28 February 2014 and 7 July 2016, 35 patients were enrolled and treated with']","['Buparlisib plus carboplatin or lomustine', 'carboplatin', 'buparlisib (80\u2009mg) plus carboplatin, n=3;\u2009and buparlisib (100\u2009mg) plus carboplatin, n=14), or buparlisib (60\u2009mg) plus lomustine', 'radiotherapy and temozolomide standard of care', 'lomustine', 'buparlisib (80\u2009mg or 100\u2009mg once daily) plus carboplatin (area under the curve (AUC)=5 every 3 weeks), or buparlisib (60\u2009mg once daily) plus lomustine', 'buparlisib plus carboplatin']","['maximum tolerable dose (MTD) and/or recommended phase II dose of buparlisib plus carboplatin or lomustine', 'overall safety profile of buparlisib', 'antitumour activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",35.0,0.0808187,"The overall safety profile of buparlisib remained unchanged, and no new or unexpected safety findings were reported in this study.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'Medical Oncology, Royal Melbourne Hospital, Melbourne, Victoria, Australia mark.rosenthal@petermac.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Oncology, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Centre René Gauducheau, Saint Herblain, Pays de la Loire, France.""}, {'ForeName': 'Miguel J', 'Initials': 'MJ', 'LastName': 'Gil-Gil', 'Affiliation': ""Institut Català d'Oncologia, Barcelona, Spain.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeGroot', 'Affiliation': 'Department of Neuro-Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': ""Department of Neuro-Oncology, Assistance Publique - Hôpitaux de Marseille Office Central des Bibliothèques, Marseille, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Idbaih', 'Affiliation': 'Department of Neuro-Oncology, Sorbonne Université, Paris, Île-de-France, France.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gan', 'Affiliation': 'Oncology, Olivia Newton-John Cancer & Wellness Centre, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Raizer', 'Affiliation': 'Department of Neuro-Oncology, Northwestern Medical Faculty Foundation, Chicago, Illinois, USA.'}, {'ForeName': 'Patrick Yung', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Department of Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Pineda', 'Affiliation': 'Medical Oncology, University of Barcelona Faculty of Medicine and Health Sciences, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Donnet', 'Affiliation': 'Novartis Pharma SAS, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Novartis Pharma, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'El-Hashimy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Mason', 'Affiliation': 'Department of Oncology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.'}]",ESMO open,['10.1136/esmoopen-2020-000672']
2645,32669140,Meeting Nutritional Targets of Critically Ill Patients by Combined Enteral and Parenteral Nutrition: Review and Rationale for the EFFORTcombo trial.,"While medical nutrition therapy is an essential part of the care for critically ill patients, uncertainty exists about the right form, dosage, timing and route in relation to the phases of critical illness. As enteral nutrition (EN) is often withheld or interrupted during the ICU stay, combined EN and parenteral nutrition (PN) may represent an effective and safe option to achieve energy and protein goals as recommended by international guidelines. We hypothesize that critically ill patients at high nutritional risk may benefit from such a combined approach during their stay on the intensive care unit (ICU). Therefore, we aim to test if an early combination of EN and high-protein PN (EN+PN) is effective in reaching calorie and protein goals in patients at high nutritional risk, while avoiding overfeeding. This approach will be tested in the here presented EFFORTcombo trial. Nutritionally high-risk ICU patients will be randomized to either high (≥2.2 mg/kg/d) or low protein (≤1.2 mg/kg/d). In the high protein group, the patients will receive EN+PN, in the low protein group, patients will be given EN alone. EN will be started in accordance to international guidelines in both groups. Efforts will be made to reach nutrition goals within 48-96 hours. The efficacy of the proposed nutritional strategy will be tested as an innovative approach by functional outcomes at ICU- and hospital-discharge, as well as at a 6-month follow-up.",2020,"Therefore, we aim to test if an early combination of EN and high-protein PN (EN+PN) is effective in reaching calorie and protein goals in patients at high nutritional risk, while avoiding overfeeding.","['critically ill patients at high nutritional risk', 'patients at high nutritional risk, while avoiding overfeeding', 'Critically Ill Patients by Combined Enteral and Parenteral Nutrition', 'Nutritionally high-risk ICU patients']","['EN+PN', 'EN and high-protein PN (EN+PN', 'combined EN and parenteral nutrition (PN', 'medical nutrition therapy', 'enteral nutrition (EN']",[],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]",[],,0.0250541,"Therefore, we aim to test if an early combination of EN and high-protein PN (EN+PN) is effective in reaching calorie and protein goals in patients at high nutritional risk, while avoiding overfeeding.","[{'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty RWTH Aachen, Aachen/ Germany.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': 'Clinical Evaluation Research Unit, Kingston General Hospital, Kingston/ Canada.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Elke', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel.'}, {'ForeName': 'Stefan J', 'Initials': 'SJ', 'LastName': 'Schaller', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care Medicine, Charité UniversitätsmedizinBerlin/ Germany.'}, {'ForeName': 'Reto', 'Initials': 'R', 'LastName': 'Stocker', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Klinik Hirslanden, Zürich/ Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Haberthür', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Klinik Hirslanden, Zürich/ Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Loeffelholz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University Hospital Jena, Jena/Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Suchner', 'Affiliation': 'Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum Darmstadt, Darmstadt/Germany.'}, {'ForeName': 'Zudin A', 'Initials': 'ZA', 'LastName': 'Puthucheary', 'Affiliation': 'William Harvey Research Institute, Queen Mary, University of London, London/United Kingdom.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Bear', 'Affiliation': 'Department of Nutrition and Dietetics, Guýs and St Thomas NHS Foundation Trust, London/United Kingdom.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ney', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty RWTH Aachen, Aachen/ Germany.'}, {'ForeName': 'Kai C', 'Initials': 'KC', 'LastName': 'Clasen', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty RWTH Aachen, Aachen/ Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt/Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lindau', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt/Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Laurentius', 'Affiliation': 'Department of Internal Medicine and Geriatrics, Franziskushospital Aachen, Aachen/ Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stoppe', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty RWTH Aachen, Aachen/ Germany.'}]",Nutrition research reviews,['10.1017/S0954422420000165']
2646,32669161,[Comparison of the efficacy of domestic and imported caffeine citrate in the treatment of apnea in preterm infants: a prospective randomized double-blind controlled trial].,"OBJECTIVE


To compare the efficacy of domestic and imported caffeine citrate in the treatment of apnea in preterm infants.
METHODS


A total of 98 preterm infants with a gestational age of 28 - <34 weeks between April 2018 and December 2019 were enrolled. They were randomly administered with domestic (n=48) or imported caffeine citrate (n=50) within 6 hours after birth. The therapeutic effects, complications, adverse effects and clinical outcomes were compared between the two groups.
RESULTS


There were no significant differences in the incidence of apnea within 7 days after birth, daily frequency of apnea, the time of apnea disappearance, the failure rate of intubation-surfactant-extubation strategy, the time of non-invasive assisted ventilation, the duration of oxygen therapy, the duration of caffeine citrate therapy, the length of hospital stay, blood gas analysis results, liver and kidney function testing results between the two groups (P>0.05). There were no significant differences in the incidence of complications and the mortality rate between the two groups (P>0.05). There was no significant difference in the incidence of adverse effects between the two groups (P>0.05).
CONCLUSIONS


The efficacy and safety of domestic caffeine citrate in the treatment of apnea are similar to those of imported caffeine citrate in preterm infants.",2020,The efficacy and safety of domestic caffeine citrate in the treatment of apnea are similar to those of imported caffeine citrate in preterm infants.,"['98 preterm infants with a gestational age of 28\u2009-\u2009<34 weeks between April 2018 and December 2019 were enrolled', 'apnea in preterm infants', 'preterm infants']","['domestic caffeine citrate', 'domestic (n=48) or imported caffeine citrate', 'domestic and imported caffeine citrate']","['incidence of apnea within 7 days after birth, daily frequency of apnea, the time of apnea disappearance, the failure rate of intubation-surfactant-extubation strategy, the time of non-invasive assisted ventilation, the duration of oxygen therapy, the duration of caffeine citrate therapy, the length of hospital stay, blood gas analysis results, liver and kidney function testing results', 'incidence of adverse effects', 'therapeutic effects, complications, adverse effects and clinical outcomes', 'incidence of complications and the mortality rate']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]","[{'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",98.0,0.0280981,The efficacy and safety of domestic caffeine citrate in the treatment of apnea are similar to those of imported caffeine citrate in preterm infants.,"[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Department of Neonatology, Xiangya Hospital, Central South University, Changsha 410008, China. shaojieyue@163.com.'}, {'ForeName': 'Zheng-Chang', 'Initials': 'ZC', 'LastName': 'Liao', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Ming-Jie', 'Initials': 'MJ', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ji-Min', 'Initials': 'JM', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'Shao-Jie', 'Initials': 'SJ', 'LastName': 'Yue', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2647,32669164,[Effect of breastfeeding on insulin sensitivity in infants with intrauterine growth retardation: a follow-up study].,"OBJECTIVE


To study insulin sensitivity and the serum level of adiponectin in infants with intrauterine growth retardation (IUGR) and the effect of breastfeeding on the insulin sensitivity through a follow-up study.
METHODS


A total of 106 full-term IUGR infants who were hospitalized from October 2014 to October 2018 were enrolled as the IUGR group, and 90 full-term appropriate for gestational age (AGA) infants who were born during the same period of time were enrolled as the AGA group. Birth weight and body length were recorded. Serum levels of fasting blood glucose (FBG), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), insulin, and adiponectin were measured on day 7 after birth. Homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. According to the feeding pattern, the IUGR group was further divided into a breastfeeding group with 37 infants and a formula feeding group with 42 infants. The above serum indices and growth indices were also measured at the age of 3 and 6 months.
RESULTS


Compared with the AGA group, the IUGR group had significantly increased levels in serum insulin and HOMA-IR and a significantly decreased level of adiponectin (P<0.05). There were no significant differences between the breastfeeding and formula feeding groups in growth indices and serum levels of FBG, TG, LDL, and HDL on day 7 after birth and at the ages of 3 and 6 months (P>0.05). In the breastfeeding group, serum insulin and HOMA-IR decreased and adiponectin level increased over the time of breastfeeding (P<0.05).
CONCLUSIONS


Insulin sensitivity decreases in the early stage after birth in IUGR infants, and breastfeeding can improve insulin sensitivity.",2020,"There were no significant differences between the breastfeeding and formula feeding groups in growth indices and serum levels of FBG, TG, LDL, and HDL on day 7 after birth and at the ages of 3 and 6 months (P>0.05).","['A total of 106 full-term IUGR infants who were hospitalized from October 2014 to October 2018 were enrolled as the IUGR group, and 90 full-term appropriate for gestational age (AGA) infants who were born during the same period of time were enrolled as the AGA group', 'infants with intrauterine growth retardation', 'infants with intrauterine growth retardation (IUGR']",['AGA'],"['level of adiponectin', 'Serum levels of fasting blood glucose (FBG), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), insulin, and adiponectin', 'Birth weight and body length', 'growth indices and serum levels of FBG, TG, LDL, and HDL', 'insulin sensitivity', 'insulin resistance (HOMA-IR', 'serum insulin and HOMA-IR decreased and adiponectin level', 'levels in serum insulin and HOMA-IR']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",106.0,0.015043,"There were no significant differences between the breastfeeding and formula feeding groups in growth indices and serum levels of FBG, TG, LDL, and HDL on day 7 after birth and at the ages of 3 and 6 months (P>0.05).","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Neonatology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan 430016, China. freeman315@163.com.""}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Xu-Wei', 'Initials': 'XW', 'LastName': 'Tao', 'Affiliation': ''}, {'ForeName': 'Ling-Kong', 'Initials': 'LK', 'LastName': 'Zeng', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2648,32669165,[Neuropsychological development of late preterm infants and early term infants at the age of 1 year: a follow-up study].,"OBJECTIVE


To study the level of neuropsychological development in late preterm infants and early term infants at the age of 1 year.
METHODS


A total of 1 257 children with a corrected age of 1 year were enrolled as subjects. According to gestational age at birth, they were divided into an early preterm group (28-33 +6  weeks), a late preterm group (34-36 +6  weeks), an early term group (37-38 +6  weeks), and a full-term group (39-41 +6  weeks). Gesell Developmental Schedules were used to assess the neuropsychological development of the children, and the groups were compared in terms of neuropsychological development at the age of 1 year.
RESULTS


There were significant differences in the developmental quotients of the five functional areas (adaptability, gross motor, fine motor, language and social ability) between the four groups at the age of 1 year (P<0.05), and the full-term infants had the highest development quotients, followed by the early term infants, the late preterm infants, and the early preterm infants (P<0.05). The full-term infants had the lowest rate of developmental delay in each functional area, while the early preterm infants had the highest rate (P<0.05). Compared with the full-term infants, the early term infants had a higher risk of developmental delay in adaptability (OR=1.796, P<0.05), and the late preterm infants had a higher risk of developmental delay in adaptability (OR=2.651, P<0.05) and fine motor (OR=2.679, P<0.05), while the early preterm infants had a higher risk of developmental delay in adaptability (OR=4.069, P<0.05), fine motor (OR=3.710, P<0.05), and social ability (OR=3.515, P<0.05).
CONCLUSIONS


The risk of neuropsychological developmental delay decreases with the increase in gestational age in children at the age of 1 year, with a dose-response effect. There are varying degrees of developmental delay in early term infants and late preterm infants, and health care follow-up for early term infants and late preterm infants should be taken seriously.",2020,"There were significant differences in the developmental quotients of the five functional areas (adaptability, gross motor, fine motor, language and social ability) between the four groups at the age of 1 year (P<0.05), and the full-term infants had the highest development quotients, followed by the early term infants, the late preterm infants, and the early preterm infants (P<0.05).","['A total of 1\u2006257 children with a corrected age of 1 year were enrolled as subjects', 'late preterm infants and early term infants at the age of 1 year']",[],"['developmental quotients of the five functional areas (adaptability, gross motor, fine motor, language and social ability', 'higher risk of developmental delay in adaptability']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}]",[],"[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}]",1257.0,0.041903,"There were significant differences in the developmental quotients of the five functional areas (adaptability, gross motor, fine motor, language and social ability) between the four groups at the age of 1 year (P<0.05), and the full-term infants had the highest development quotients, followed by the early term infants, the late preterm infants, and the early preterm infants (P<0.05).","[{'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Liang', 'Affiliation': ""Department of Child Health Care, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, China. yansong84@126.com.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Yan-Fei', 'Initials': 'YF', 'LastName': 'Xing', 'Affiliation': ''}, {'ForeName': 'Sui-Fang', 'Initials': 'SF', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Song', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2649,32234756,TP53  Mutations Predict Sensitivity to Adjuvant Gemcitabine in Patients with Pancreatic Ductal Adenocarcinoma: Next-Generation Sequencing Results from the CONKO-001 Trial.,"PURPOSE


We performed next-generation sequencing (NGS) in the CONKO-001 phase III trial to identify clinically relevant prognostic and predictive mutations and conducted a functional validation in The Cancer Genome Atlas (TCGA) sequencing data.
EXPERIMENTAL DESIGN


Patients of the CONKO-001 trial received curatively intended surgery for pancreatic adenocarcinoma (PDAC) followed by adjuvant chemotherapy with gemcitabine (Gem) or observation only (Obs). Tissue samples of 101 patients were evaluated by NGS of 37 genes. Cox proportional hazard models were applied for survival analysis. In addition, functional genomic analyses were performed in an NGS and RNA-sequencing dataset of 146 pancreatic tumors from TCGA.
RESULTS


The most common mutations in the CONKO cohort were  KRAS  (75%),  TP53  (60%),  SMAD4  (10%),  CDKNA2  (9%), as well as SWI/SNF (12%) complex alterations. In untreated patients,  TP53  mutations were a negative prognostic factor for disease-free survival (DFS; HR mut vs. WT 2.434,  P  = 0.005). With respect to gemcitabine treatment,  TP53  mutations were a positive predictive factor for gemcitabine efficacy [ TP53 mut: HR for DFS Gem vs. Obs, 0.235 (0.130 - 0.423;  P  < 0.001);  TP53 wt: HR for DFS Gem vs. Obs, 0.794 (0.417 - 1.513;  P  = 0.483)] with a significant test for interaction ( P  = 0.003). In the TCGA dataset,  TP53  mutations were associated with shortened DFS.
CONCLUSIONS


In CONKO-001, the benefit from adjuvant gemcitabine was confined to the  TP53 mut patient group. This potentially clinical relevant observation needs to be confirmed in independent prospective studies. The sensitivity of TP53mut PDAC to gemcitabine in CONKO-001 provides a lead for further mechanistic investigations.",2020,"With respect to gemcitabine treatment,  TP53  mutations were a positive predictive factor for gemcitabine efficacy [ TP53 mut: HR for DFS Gem vs. Obs, 0.235 (0.130 - 0.423;  P  < 0.001);  TP53 wt: HR for DFS Gem vs. Obs, 0.794 (0.417 - 1.513;  ","['101 patients were evaluated by NGS of 37 genes', 'Patients of the CONKO-001 trial received curatively intended surgery for pancreatic adenocarcinoma (PDAC) followed by', 'Patients with Pancreatic Ductal Adenocarcinoma']","['gemcitabine', 'Gemcitabine', 'adjuvant chemotherapy with gemcitabine (Gem) or observation only (Obs']",['negative prognostic factor for disease-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",101.0,0.0277672,"With respect to gemcitabine treatment,  TP53  mutations were a positive predictive factor for gemcitabine efficacy [ TP53 mut: HR for DFS Gem vs. Obs, 0.235 (0.130 - 0.423;  P  < 0.001);  TP53 wt: HR for DFS Gem vs. Obs, 0.794 (0.417 - 1.513;  ","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Department of Medical Oncology and Haematology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. ma.sinn@uke.de.'}, {'ForeName': 'Bruno V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Treue', 'Affiliation': 'Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Damm', 'Affiliation': 'Department of Medical Oncology and Haematology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Schmuck', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lohneis', 'Affiliation': 'Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Klauschen', 'Affiliation': 'Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Jana K', 'Initials': 'JK', 'LastName': 'Striefler', 'Affiliation': 'Department of Medical Oncology and Haematology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bahra', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Bläker', 'Affiliation': 'Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bischoff', 'Affiliation': 'Department of Medical Oncology and Haematology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Department of Medical Oncology and Haematology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Oettle', 'Affiliation': 'Outpatient Department of Hematology/Oncology, Friedrichshafen, Germany.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Department of Medical Oncology and Haematology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Budczies', 'Affiliation': 'Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3034']
2650,32552685,A phase 2b/3b MenACWY-TT study of long-term antibody persistence after primary vaccination and immunogenicity and safety of a booster dose in individuals aged 11 through 55 years.,"BACKGROUND


A previous phase 2 study demonstrated the immunogenicity of a single dose of meningococcal A, C, W, Y-tetanus toxoid conjugate (MenACWY-TT) or polysaccharide (MenACWY-PS) vaccine for up to 5 years in individuals aged 11-55 years. This follow-up study evaluated long-term antibody persistence up to 10 years and the immunogenicity and safety of a single MenACWY-TT booster dose given 10 years after primary vaccination.
METHODS


Blood draws were conducted annually in Years 7-10. At Year 10, all subjects received a MenACWY-TT booster dose. Blood was drawn at 1 month and safety data were collected ≤6 months postbooster. Study endpoints included immunogenicity during the persistence phase (primary), and immunogenicity and safety during the booster phase (secondary). Statistical analyses were descriptive.
RESULTS


A total of 311 subjects were enrolled in the persistence phase (MenACWY-TT, 235; MenACWY-PS, 76); 220 were enrolled in the booster phase (MenACWY-TT, 164; MenACWY-PS, 56). Descriptive analyses indicated that at Years 7-10, the percentages of subjects achieving serum bactericidal antibody assay using baby rabbit complement (rSBA) titers ≥1:8 and ≥1:128 were higher for serogroups A, W, and Y in the MenACWY-TT versus MenACWY-PS group; percentages were similar across groups for serogroup C. rSBA geometric mean titers (GMTs) for serogroups A, W, and Y were higher in the MenACWY-TT group and slightly higher in the MenACWY-PS group for serogroup C. One month postbooster, all primary MenACWY-TT and ≥98.1% of primary MenACWY-PS recipients had rSBA titers ≥1:8. For all serogroups, rSBA GMTs postbooster were higher in the MenACWY-TT versus MenACWY-PS group. Most local and general reactogenicity events were similar between groups and mild to moderate in severity. Adverse events at 1 month postbooster were 9.1% for the MenACWY-TT and 3.6% for the MenACWY-PS groups; all were nonserious.
CONCLUSIONS


Immune responses to a single MenACWY-TT primary dose administered at age 11-55 years persisted in >70% of individuals evaluated at Years 7-10. A MenACWY-TT booster dose administered at Year 10 was safe and immunogenic with no new safety signals observed. These results provide important insights regarding long-term protection from primary vaccination and the benefits of booster dosing.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT01934140. Registered September 2013.",2020,A MenACWY-TT booster dose administered at Year 10 was safe and immunogenic with no new safety signals observed.,"['311 subjects were enrolled in the persistence phase (MenACWY-TT, 235; MenACWY-PS, 76); 220 were enrolled in the booster phase (MenACWY-TT, 164; MenACWY-PS, 56', 'Blood draws were conducted annually in Years 7-10', 'up to 5\u2009years in individuals aged 11-55\u2009years', 'individuals aged 11 through 55\u2009years']",['tetanus toxoid conjugate (MenACWY-TT) or polysaccharide (MenACWY-PS) vaccine'],"['immunogenicity and safety', 'serum bactericidal antibody assay using baby rabbit complement (rSBA) titers', 'immunogenicity during the persistence phase (primary), and immunogenicity and safety during the booster phase (secondary', 'Adverse events']","[{'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2936353', 'cui_str': 'Serum Bactericidal Antibody Assays'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",311.0,0.0746704,A MenACWY-TT booster dose administered at Year 10 was safe and immunogenic with no new safety signals observed.,"[{'ForeName': 'Charissa Fay Corazon', 'Initials': 'CFC', 'LastName': 'Borja-Tabora', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang Muntinlupa City, Metro Manila, Philippines.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Peyrani', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA. paula.peyrani@pfizer.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Hurley, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van der Wielen', 'Affiliation': 'Global Vaccines Research and Development, GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Cheuvart', 'Affiliation': 'Global Vaccines Research and Development, GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'De Schrevel', 'Affiliation': 'Global Vaccines Research and Development, GlaxoSmithKline, Rixensart, Belgium.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Bianco', 'Affiliation': 'Global Vaccines Research and Development, GlaxoSmithKline, Rockville, MD, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Aris', 'Affiliation': 'Value Evidence, Medical, Research and Development, GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cutler', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}]",BMC infectious diseases,['10.1186/s12879-020-05104-5']
2651,28388220,Participant Experiences of Attending a Community CBT Workshop for Insomnia: A Qualitative Six-Year Follow-Up.,"Objective/Background:  Our aim was to qualitatively explore the experiences of people who attended a one-day sleep workshop six years previously.  Participants:  Of the 95 people who originally attended the workshop and a three-month follow-up, 14 individuals (mean age = 63.6 years) participated.  Methods:  Semi-structured interviews were used to explore: participants' experiences of insomnia since the workshop, memories of the techniques and information provided and the perceived impact of the workshop on their lives. Qualitative data were analyzed using the principles of Framework Analysis.  Results:  Interviews produced rich accounts of attributions of changes in sleep, the application of taught strategies and general experiences of the workshop.  Conclusions:  This research highlights which aspects of a large-scale intervention may be most helpful for individuals experiencing sleep difficulties and what factors may contribute to changes in sleep over time.",2019,"Results:  Interviews produced rich accounts of attributions of changes in sleep, the application of taught strategies and general experiences of the workshop.  ","['people who attended a one-day sleep workshop six years previously', 'Participant Experiences of Attending a Community CBT Workshop for Insomnia', 'Participants:  Of the 95 people who originally attended the workshop and a three-month follow-up, 14 individuals (mean age = 63.6 years) participated']",[],"['attributions of changes in sleep, the application of taught strategies and general experiences of the workshop']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]",95.0,0.0294293,"Results:  Interviews produced rich accounts of attributions of changes in sleep, the application of taught strategies and general experiences of the workshop.  ","[{'ForeName': 'Georgina L', 'Initials': 'GL', 'LastName': 'Barnes', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, England.""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Lawrence', 'Affiliation': ""Department of Health Sciences and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, England.""}, {'ForeName': 'Mizanur', 'Initials': 'M', 'LastName': 'Khondoker', 'Affiliation': ""Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, England.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, England.""}, {'ForeName': 'June S L', 'Initials': 'JSL', 'LastName': 'Brown', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, England.""}]",Behavioral sleep medicine,['10.1080/15402002.2017.1301942']
2652,32669450,Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 pivotal studies.,"OBJECTIVE


This study evaluated the effect of ixekizumab on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biologic disease modifying antirheumatic drugs naïve (bDMARD-naïve) or failed at least 1 tumor necrosis factor inhibitor (TNFi).
METHODS


In 2 multicenter, randomized, double-blind, placebo-controlled, and active-controlled (bDMARD-naïve only) trials, r-axSpA patients were randomly assigned to receive 80 mg of ixekizumab (every 2 weeks [Q2W] or every 4 weeks [Q4W]), placebo, or adalimumab (bDMARD-naïve only). After 16 weeks, patients who received placebo or adalimumab were re-randomized to receive ixekizumab (Q2W or Q4W) up to Week 52. Functioning and health was measured by the generic Short Form Health Survey 36-item (SF-36) and the diseasespecific ASAS Health Index (ASAS HI). Societal health utility was assessed by the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L).
RESULTS


At week 16, both doses of ixekizumab in bDMARD-naïve and TNFi-experienced patients resulted in larger improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical. Larger proportion of patients reaching improvement in ASAS HI ≥3, ASAS HI good health status were reported in patients treated with ixekizumab. Improvements were maintained through Week 52.
CONCLUSION


Ixekizumab significantly improved functioning and health as assessed by both generic and disease specific measures as well as societal health utility values in patients with raxSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16 and improvements were sustained through 52 weeks.",2020,"For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical.","['Radiographic Axial Spondyloarthritis', 'patients with radiographic axial spondyloarthritis (r-axSpA) who were either biologic disease modifying antirheumatic drugs naïve (bDMARD-naïve) or failed at least 1 tumor necrosis factor inhibitor (TNFi']","['placebo or adalimumab', 'placebo, or adalimumab (bDMARD-naïve only', 'ixekizumab (Q2W or Q4W', 'ixekizumab', 'Ixekizumab', 'placebo']","['bodily pain, physical function, and role physical', 'European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L', 'societal health utility values', 'generic Short Form Health Survey 36-item (SF-36) and the diseasespecific ASAS Health Index (ASAS HI', 'ASAS HI ≥3, ASAS HI good health status', 'Functioning and health', 'functioning and health', 'SF-36, ASAS HI, and EQ-5D-5L versus placebo', 'SF-36, ASAS HI, and EQ-5D-5L', 'Societal health utility']","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",,0.28825,"For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical.","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Kiltz', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'James Cheng-Chung', 'Initials': 'JC', 'LastName': 'Wei', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'van den Bosch', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hunter', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Carlier', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bolce', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne Germany; Ruhr-University Bochum, Bochum, Germany; Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA; Rheumatology, Maastricht University Medical Center, Maastricht, the Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; University of California San Francisco, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Stanford University School of Medicine, Palo Alto, CA, USA. Address correspondence to Uta Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. uta.kiltz@elisabethgruppe.de.'}]",The Journal of rheumatology,['10.3899/jrheum.200093']
2653,32669487,Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial.,"Approximately 90% of low back pain (LBP) diagnoses are non-specific (NSLBP; i.e. with unknown cause). In NSLBP patients, the hamstrings, iliopsoas, piriformis, and tensor fasciae latae are overactive due to weak hip abductor, extensor, and core muscles. Core stability is essential for proper load balance within the pelvis, spine, and kinetic chain, and core stability exercise (CSE) is an exercise treatment regimen for LBP conditions. We investigated how core stability and hip muscle stretching exercises affected NSLBP patients' physical function and activity. Patients were randomly allocated to three groups. The Stretch group (n = 24) performed exercises for hip muscle stretching for maximal motion; the Strengthen group (n = 22) performed exercises for hip muscle strengthening while maintaining the maximal isometric contraction. The Sham group (n = 20) received gentle palpation of the skin. Therapy was conducted thrice weekly for 6 weeks. Pain intensity, lower back instability, and hip muscle flexibility were measured to assess physical function. Disability level, balance ability, and quality of life were measured to assess physical activity. Data were collected prior to intervention and at 6-week follow-up. There were significant within-group changes for all measurements (P < 0.05). The Stretch and Strengthen groups had greater improvements in pain intensity, disability level, balance ability, and quality of life than the Sham group. Lower back instability and hip muscle flexibility had the greatest improvement in the Stretch group. In conclusion, CSE and hip muscle stretching are effective at improving physical function and activity in NSLBP patients.",2020,"The Stretch and Strengthen groups had greater improvements in pain intensity, disability level, balance ability, and quality of life than the Sham group.","['NSLBP patients', 'Patients with Non-Specific Low Back Pain']","['Core Stability and Hip Exercises', 'exercises for hip muscle stretching for maximal motion; the Strengthen group (n = 22) performed exercises for hip muscle strengthening while maintaining the maximal isometric contraction', 'gentle palpation of the skin']","['Pain intensity, lower back instability, and hip muscle flexibility', 'Lower back instability and hip muscle flexibility', 'Disability level, balance ability, and quality of life', 'pain intensity, disability level, balance ability, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0454362', 'cui_str': 'Hip exercises'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0585005,"The Stretch and Strengthen groups had greater improvements in pain intensity, disability level, balance ability, and quality of life than the Sham group.","[{'ForeName': 'Beomryong', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, The Graduate School of Sahmyook University.'}, {'ForeName': 'Jongeun', 'Initials': 'J', 'LastName': 'Yim', 'Affiliation': 'Department of Physical Therapy, The Graduate School of Sahmyook University.'}]",The Tohoku journal of experimental medicine,['10.1620/tjem.251.193']
2654,32669521,Comparative efficacy and safety of Verbascox ®  - a proprietary herbal extract capable of inhibiting human cyclooxygenase-2 - and celecoxib for knee osteoarthritis.,"The aim of this randomized, single-blind, active-controlled pilot study was to investigate the clinical efficacy of oral supplementation with Verbascox ® , a proprietary herbal extract capable of inhibiting human cyclooxygenase-2 (COX-2), in patients with mild-to-moderate osteoarthritis (OA) of the knee. Patients in the control group (n = 50) did not undergo any treatment (watchful waiting). Patients in the Verbascox ®  group (n = 50) received oral supplementation (800 mg/day) with the herbal extract for 2 weeks. The final study group consisted of patients (n = 50) who received celecoxib, a known pharmacological inhibitor of COX-2, 200 mg/day for 2 weeks. Examining physicians and laboratory personnel were blinded to group assignment, whereas patients were unblinded. All participants were evaluated using standard measures of pain relief and improvement in functional capacity at baseline, after 1 week, and at the end of the 2-week treatment course. Moreover, serum levels of substance P (SP), a member of the tachykinin family of neuropeptides involved in pain perception, were measured at the three time points. Both Verbascox ®  and celecoxib reduced pain, improved functional capacity, and lowered serum SP levels at 2 weeks compared with baseline, without significant inter-arm differences. Both Verbascox ®  and celecoxib showed a limited number of treatment-emergent adverse events. In summary, oral supplementation with Verbascox ®  (800 mg/day) in patients with mild-to-moderate OA of the knee is as effective and safe as a standard therapeutic dose of celecoxib in terms of pain relief and improvement in functional capacity after a 2-week treatment course.",2020,"Both Verbascox ®  and celecoxib reduced pain, improved functional capacity, and lowered serum SP levels at 2 weeks compared with baseline, without significant inter-arm differences.","['knee osteoarthritis', 'patients with mild-to-moderate osteoarthritis (OA) of the knee']","['oral supplementation with Verbascox ®', 'herbal extract', 'celecoxib, a known pharmacological inhibitor of COX-2', 'Verbascox ®', 'oral supplementation', 'celecoxib']","['serum levels of substance P (SP), a member of the tachykinin family of neuropeptides involved in pain perception', 'pain, improved functional capacity, and lowered serum SP levels', 'pain relief and improvement in functional capacity']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0039241', 'cui_str': 'Tachykinin'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.0756157,"Both Verbascox ®  and celecoxib reduced pain, improved functional capacity, and lowered serum SP levels at 2 weeks compared with baseline, without significant inter-arm differences.","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Nannoni', 'Affiliation': 'R&D, LaBiotre srl, Tavarnelle Val di Pesa (FI), Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Volterrani', 'Affiliation': 'R&D, LaBiotre srl, Tavarnelle Val di Pesa (FI), Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mattarocci', 'Affiliation': 'R&D, LaBiotre srl, Tavarnelle Val di Pesa (FI), Italy.'}, {'ForeName': 'Piercarlo', 'Initials': 'P', 'LastName': 'Minoretti', 'Affiliation': 'Studio Minoretti, Oggiono (LC), Italy.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Emanuele', 'Affiliation': '2E Science, Via Monte Grappa, Robbio (PV), Italy.'}]",Drug discoveries & therapeutics,['10.5582/ddt.2020.03034']
2655,32669622,Correction: A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],['international scientific SCI exercise guidelines'],['SCI chronic pain'],[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.173102,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada. kathleen_martin.ginis@ubc.ca.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'van der Scheer', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kendra R', 'Initials': 'KR', 'LastName': 'Todd', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Centre for Chronic Disease Prevention and Management, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gaudet', 'Affiliation': 'Spinal Cord Injury British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Hoekstra', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Mohammad Ehsanul', 'Initials': 'ME', 'LastName': 'Karim', 'Affiliation': 'School of Population and Public Health and Centre for Health Evaluation and Outcome Sciences, Providence Health Care, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John L K', 'Initials': 'JLK', 'LastName': 'Kramer', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, UBC; Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Townson', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}]",Spinal cord,['10.1038/s41393-020-0519-2']
2656,32669641,Usefulness of three-dimensional printing of superior mesenteric vessels in right hemicolon cancer surgery.,"The anatomy of the superior mesenteric vessels is complex, yet important, for right-sided colorectal surgery. The usefulness of three-dimensional (3D) printing of these vessels in right hemicolon cancer surgery has rarely been reported. In this prospective clinical study, 61 patients who received laparoscopic surgery for right hemicolon cancer were preoperatively randomized into 3 groups: 3D-printing (20 patients), 3D-image (19 patients), and control (22 patients) groups. Surgery duration, bleeding volume, and number of lymph node dissections were designed to be the primary end points, whereas postoperative complications, post-operative flatus recovery time, duration of hospitalization, patient satisfaction, and medical expenses were designed to be secondary end points. To reduce the influence of including different surgeons in the study, the surgical team was divided into 2 groups based on surgical experience. The duration of surgery for the 3D-printing and 3D-image groups was significantly reduced (138.4 ± 19.5 and 154.7 ± 25.9 min vs. 177.6 ± 24.4 min, P = 0.000 and P = 0.006), while the number of lymph node dissections for the these 2 groups was significantly increased (19.1 ± 3.8 and 17.6 ± 3.9 vs. 15.8 ± 3.0, P = 0.001 and P = 0.024) compared to the control group. Meanwhile, the bleeding volume for the 3D-printing group was significantly reduced compared to the control group (75.8 ± 30.4 mL vs. 120.9 ± 39.1 mL, P = 0.000). Moreover, patients in the 3D-printing group reported increased satisfaction in terms of effective communication compared to those in the 3D-image and control groups. Medical expenses decreased by 6.74% after the use of 3D-printing technology. Our results show that 3D-printing technology could reduce the duration of surgery and total bleeding volume and increase the number of lymph node dissections. 3D-printing technology may be more helpful for novice surgeons.Trial registration: Chinese Clinical Trial Registry, ChiCTR1800017161. Registered on 15 July 2018.",2020,Our results show that 3D-printing technology could reduce the duration of surgery and total bleeding volume and increase the number of lymph node dissections.,"['61 patients who received', 'right hemicolon cancer surgery', 'for right hemicolon cancer']",['laparoscopic surgery'],"['effective communication', 'Medical expenses', 'number of lymph node dissections', 'satisfaction', 'duration of surgery', 'duration of surgery and total bleeding volume', 'bleeding volume', 'postoperative complications, post-operative flatus recovery time, duration of hospitalization, patient satisfaction, and medical expenses', 'Surgery duration, bleeding volume, and number of lymph node dissections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",61.0,0.0319269,Our results show that 3D-printing technology could reduce the duration of surgery and total bleeding volume and increase the number of lymph node dissections.,"[{'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Operating Room, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhequn', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Harbin JunYang Technology Co., Ltd, Harbin, 150000, People's Republic of China.""}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Operating Room, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Jiazeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China. xjz_wuxi@alumni.sjtu.edu.cn.""}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of General Surgery, First Affiliated Hospital of Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210029, People's Republic of China. xuzekuan@njmu.edu.cn.""}]",Scientific reports,['10.1038/s41598-020-68578-y']
2657,32669769,Effect of Yoga and Exercise on Glycemic Control and Psychosocial Parameters in Type 2 Diabetes Mellitus: A Randomized Controlled Study.,"Context Background


Type 2 diabetes has been strongly associated with psychosocial factors such as stress, anxiety, depression, and quality of life (QOL). There is not much evidence whether yoga can improve these factors and motivate individuals to engage in active lifestyle.
Aims


This study aims to evaluate the effect of yoga and exercise over glycemic control, anxiety, depression, exercise self-efficacy (ESE), and QOL after 3-month program.
Methods


Two hundred and twenty-seven individuals were randomly allocated to yoga group (YG) and exercise group. YG practiced yoga for 2 weeks under supervision and then carried out practice at home for 3 months. The exercise group practiced 30 min of brisk walking for 5 days a week.
Results


On comparison among the groups, in YG, there was a mean change of 0.47 in glycated hemoglobin which was greater than mean reduction of 0.28 in the exercise group with  P  < 0.05. State anxiety reduced by 7.8 and trait anxiety reduced by 4.4 in YG ( P  < 0.05) in 3 months as compared to nonsignificant reductions of 3 and 1 in mean of state and trait anxiety scores in the exercise group ( P  > 0.05). There was a statistically significant reduction in depression score in both the groups, 8.6 in yoga and 4.0 in exercise, which was greater in YG. ESE improved by 19.2 in YG ( P  < 0.05), whereas it improved only 2.2 in the exercise group ( P  > 0.05). QOL improved by 23.7 in YG and 3.0 in the exercise group which was nonsignificant in the exercise group as compared to YG.
Conclusions


Yoga is superior to exercise alone as a lifestyle modification program in improving glycemic control, anxiety, depression, and QOL as well as ESE.",2020,"QOL improved by 23.7 in YG and 3.0 in the exercise group which was nonsignificant in the exercise group as compared to YG.
","['Methods\n\n\nTwo hundred and twenty-seven individuals', 'Type 2 Diabetes Mellitus']","['Yoga and Exercise', 'yoga and exercise', 'yoga group (YG) and exercise group', 'exercise group practiced 30 min of brisk walking for 5 days a week']","['State anxiety', 'QOL', 'glycated hemoglobin', 'glycemic control, anxiety, depression, and QOL', 'depression score', 'stress, anxiety, depression, and quality of life (QOL', 'trait anxiety', 'Glycemic Control and Psychosocial Parameters', 'ESE', 'mean of state and trait anxiety scores', 'glycemic control, anxiety, depression, exercise self-efficacy (ESE), and QOL']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301808', 'cui_str': 'State'}]",227.0,0.0216903,"QOL improved by 23.7 in YG and 3.0 in the exercise group which was nonsignificant in the exercise group as compared to YG.
","[{'ForeName': 'Vijay Pratap', 'Initials': 'VP', 'LastName': 'Singh', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Karnataka, India.'}, {'ForeName': 'Bidita', 'Initials': 'B', 'LastName': 'Khandelwal', 'Affiliation': 'Professor of Medicine, Sikkim Manipal University, Sikkim Manipal Institute of Medical Sciences, Gangtok, Sikkim, India.'}]",International journal of yoga,['10.4103/ijoy.IJOY_45_19']
2658,32669771,Yoga for Functional Fitness in Adults with Intellectual and Developmental Disabilities.,"Background


Yoga is an effective intervention to improve functional fitness in adults with and without disabilities, but little research exists regarding yoga's impact on functional fitness for individuals with intellectual and developmental disabilities (IDDs).
Aims


The purpose of this study was to examine the benefits of a group yoga intervention on the functional fitness of adults with IDDs.
Methods and Materials


This yoga intervention included 12 sessions of yoga over 7 weeks (60-min sessions twice a week) at a special population recreation and leisure program. The functional fitness test was used to examine physical functioning before and after the yoga intervention.
Results and Conclusions


Eight adults completed the baseline and posttest measures (age mean = 31; standard deviation = 6.55; 50% male). There were significant improvements in lower-body strength (9.00 ± 4.63 vs. 11.50 ± 3.16,  P  = 0.04, 28% improvement), upper-body strength (11.25 ± 3.54 vs. 14.25 ± 3.37,  P  = 0.018, 27% improvement), and agility and balance (9.29 ± 4.1 vs. 6.60 ± 1.54,  P  = 0.036, 29% improvement). Functional fitness often declines for people with IDD at a faster rate than the general population; thus, these significant changes indicate that a yoga intervention may enhance functional fitness for people with IDD. Clinicians or other healthcare providers might consider yoga as a means to improve functional fitness in adults with IDDs.",2020,"There were significant improvements in lower-body strength (9.00 ± 4.63 vs. 11.50 ± 3.16,  P  = 0.04, 28% improvement), upper-body strength (11.25 ± 3.54 vs. 14.25 ± 3.37,  P  = 0.018, 27% improvement), and agility and balance (9.29 ± 4.1 vs. 6.60 ± 1.54,  P  = 0.036, 29% improvement).","['individuals with intellectual and developmental disabilities (IDDs', 'adults with IDDs', 'people with IDD', 'adults with and without disabilities', 'Adults with Intellectual and Developmental Disabilities']","['\n\n\nYoga', 'group yoga intervention']","['agility and balance', 'upper-body strength', 'lower-body strength', 'functional fitness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",50.0,0.0249456,"There were significant improvements in lower-body strength (9.00 ± 4.63 vs. 11.50 ± 3.16,  P  = 0.04, 28% improvement), upper-body strength (11.25 ± 3.54 vs. 14.25 ± 3.37,  P  = 0.018, 27% improvement), and agility and balance (9.29 ± 4.1 vs. 6.60 ± 1.54,  P  = 0.036, 29% improvement).","[{'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Reina', 'Affiliation': 'Department of Health Promotion and Behavior, College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Em V', 'Initials': 'EV', 'LastName': 'Adams', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Claire K', 'Initials': 'CK', 'LastName': 'Allison', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Kaitlin E', 'Initials': 'KE', 'LastName': 'Mueller', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Brandi M', 'Initials': 'BM', 'LastName': 'Crowe', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'van Puymbroeck', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Department of Occupational Therapy, College of Health and Human Sciences, Colorado State University, Fort Collins, CO, USA.'}]",International journal of yoga,['10.4103/ijoy.IJOY_57_19']
2659,32669858,Clinical Utility of Selinexor/Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma: A Review of Current Evidence and Patient Selection.,"Multiple myeloma (MM) is one the most common hematological malignancies, and despite the survival prolongation offered by proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs) and anti-CD38 monoclonal antibodies, the need for novel agents is prominent. Selinexor is a first-in-class, oral, selective inhibitor of exportin-1 (XPO1), a vital protein for the exportation of more than 200 tumor suppressor proteins from the nucleus. Both in solid tumors and hematologic malignancies, selinexor-mediated inhibition of nucleus export seems to effectively lead to cancer cell death. Selinexor in combination with dexamethasone (Sd) received an accelerated FDA approval on July 2019 for heavily pretreated patients with relapsed/refractory MM (RRMM) based on the promising results of the Phase II STORM trial. The preliminary results of the randomized Phase III BOSTON trial have shown a 47% increase in progression-free survival among PI-sensitive, RRMM patients who received selinexor with bortezomib-dexamethasone compared with bortezomib-dexamethasone alone. Several different selinexor-containing triplet regimens are currently being tested in the RRMM setting in an umbrella trial, and the preliminary results seem promising. Furthermore, the addition of selinexor in other anti-myeloma agents seems to overcome drug-acquired resistance in preclinical studies. The main toxicities of selinexor are gastrointestinal disorders and hematologic toxicities (mainly thrombocytopenia); however, they are manageable with proper supportive measures. In conclusion, selinexor is a new anti-myeloma drug that seems to be effective in patients who have no other therapeutic options, including patients who have received novel cellular therapies such as CAR-T cells. Its potential role earlier in the therapeutic algorithm of MM is currently under clinical investigation.",2020,"The preliminary results of the randomized Phase III BOSTON trial have shown a 47% increase in progression-free survival among PI-sensitive, RRMM patients who received selinexor with bortezomib-dexamethasone compared with bortezomib-dexamethasone alone.","['Patients with Relapsed or Refractory Multiple Myeloma', 'patients who have no other therapeutic options, including patients who have received novel cellular therapies such as CAR-T cells']","['selinexor', 'dexamethasone', 'bortezomib-dexamethasone', 'selinexor with bortezomib-dexamethasone', 'Selinexor/Dexamethasone']","['progression-free survival', 'hematologic toxicities (mainly thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",,0.042563,"The preliminary results of the randomized Phase III BOSTON trial have shown a 47% increase in progression-free survival among PI-sensitive, RRMM patients who received selinexor with bortezomib-dexamethasone compared with bortezomib-dexamethasone alone.","[{'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Malandrakis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Ntanasis-Stathopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gavriatopoulou', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Terpos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",OncoTargets and therapy,['10.2147/OTT.S227166']
2660,32669869,Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia.,"Purpose


Vixotrigine (BIIB074) is a voltage- and use-dependent sodium channel blocker. These studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with trigeminal neuralgia (TN) using enriched enrollment randomized withdrawal trial designs.
Patients and Methods


Two double-blind randomized withdrawal studies are planned to evaluate the efficacy and safety of vixotrigine compared with placebo in participants with TN (NCT03070132 and NCT03637387). Participant criteria include ≥18 years old who have classical, purely paroxysmal TN diagnosed ≥3 months prior to study entry, who experience ≥3 paroxysms of pain/day. The two studies will include a screening period, 7-day run-in period, a 4- or 6-week single-dose-blind dose-optimization period (Study 1) or 4-week open-label period (Study 2), and 14-week double-blind period. Participants will receive vixotrigine 150 mg orally three times daily in the dose-optimization and open-label periods. The primary endpoint of both studies is the proportion of participants classified as responders at Week 12 of the double-blind period. Secondary endpoints include safety measures, quality of life, and evaluation of vixotrigine population pharmacokinetics.
Conclusion


There is a need for an effective, well-tolerated, noninvasive treatment for the neuropathic pain associated with TN. The proposed studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with TN.",2020,"These studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with trigeminal neuralgia (TN) using enriched enrollment randomized withdrawal trial designs.
","['pain experienced by patients with TN', 'Trigeminal Neuralgia', 'patients with trigeminal neuralgia (TN', 'Participant criteria include ≥18 years old who have classical, purely paroxysmal TN diagnosed ≥3 months prior to study entry, who experience ≥3 paroxysms of pain/day']","['placebo', 'vixotrigine', 'vixotrigine 150 mg orally three times daily in the dose-optimization and open-label periods', 'Vixotrigine']","['efficacy and safety', 'safety measures, quality of life, and evaluation of vixotrigine population pharmacokinetics']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040997', 'cui_str': 'Trigeminal neuralgia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.148409,"These studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with trigeminal neuralgia (TN) using enriched enrollment randomized withdrawal trial designs.
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kotecha', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Cheshire', 'Affiliation': 'Department of Neurology, Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Finnigan', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Giblin', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Naik', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Convergence Pharmaceuticals, a Biogen Company, Cambridge, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tate', 'Affiliation': 'Convergence Pharmaceuticals, a Biogen Company, Cambridge, UK.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Zakrzewska', 'Affiliation': 'Facial Pain Unit and Pain Management Centre, University College London Hospitals NHS Foundation Trust/University College London, London, UK.'}]",Journal of pain research,['10.2147/JPR.S247182']
2661,32669916,Erratum: Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study [Corrigendum].,[This corrects the article DOI: 10.2147/DNND.S76523.].,2015,[This corrects the article DOI: 10.2147/DNND.S76523.].,"['subjects with progressive multiple sclerosis', 'Erratum']",['Multimodal intervention'],['fatigue and quality of life'],"[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0159325,[This corrects the article DOI: 10.2147/DNND.S76523.].,[],Degenerative neurological and neuromuscular disease,['10.2147/DNND.S94278']
2662,32669957,Management of Postoperative Pain after Elective Craniotomy: A Prospective Randomized Controlled Trial of a Neurosurgical Enhanced Recovery after Surgery (ERAS) Program.,"Objective:  To prospectively evaluate the efficacy of a neurosurgical enhanced recovery after surgery (ERAS) protocol on the management of postoperative pain after elective craniotomies.  Methods:  This randomized controlled trial was conducted in the neurosurgical center of Tangdu Hospital (Fourth Military Medical University, Xi'an, China). A total of 129 patients undergoing craniotomies between October 2016 and July 2017 were enrolled in a randomized clinical trial comparing an ERAS protocol to a conventional postoperative care regimen. The primary outcome was the postoperative pain score assessed by a verbal numerical rating scale (NRS).  Results:  Patients in the ERAS group had a significant reduction in their postoperative pain scores on POD 1 compared to patients in the control group (p < 0.05). More patients (n = 44, 68.8%) in the ERAS group experienced mild pain (NRS: 1 to 3) on POD1 compared with patients (n = 23, 35.4%) in the control group (p < 0.05). A further reduction in pain scores was also observed on POD 2 and maintained on POD 3 in the ERAS group compared with that in the control group. In addition, the median postoperative length of hospital stay was significantly decreased with the incorporation of the ERAS protocol compared to controls (ERAS: 4 days, control: 7 days, P<0.001).  Conclusion:  The implementation of a neurosurgical ERAS protocol for elective craniotomy patients has significant benefits in alleviating postoperative pain and enhancing recovery leading to early discharge after surgery compared to conventional care. Further evaluation of this protocol in larger, multi-center studies is warranted.",2020,Patients in the ERAS group had a significant reduction in their postoperative pain scores on POD 1 compared to patients in the control group (p < 0.05).,"['Postoperative Pain after Elective Craniotomy', ""neurosurgical center of Tangdu Hospital (Fourth Military Medical University, Xi'an, China"", '129 patients undergoing craniotomies between October 2016 and July 2017', 'elective craniotomy patients', 'postoperative pain after elective craniotomies']","['neurosurgical enhanced recovery after surgery (ERAS) protocol', 'ERAS protocol to a conventional postoperative care regimen', 'ERAS', 'Neurosurgical Enhanced Recovery after Surgery (ERAS) Program']","['pain scores', 'postoperative pain scores', 'POD1', 'postoperative pain score assessed by a verbal numerical rating scale (NRS', 'median postoperative length of hospital stay', 'mild pain']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}]",129.0,0.125422,Patients in the ERAS group had a significant reduction in their postoperative pain scores on POD 1 compared to patients in the control group (p < 0.05).,"[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Sankey', 'Affiliation': 'Duke University Hospital. Durham, NC. USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': ""Department of Anesthesiology, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Binrong', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhengmin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Jiangtao', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Binfang', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Nutrition, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Lanfu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Yufu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Haijing', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University. Xi'an, China.""}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi, China.""}]",International journal of medical sciences,['10.7150/ijms.46403']
2663,32669984,Application of Dexmedetomidine in Cardiopulmonary Bypass Prefilling.,"Objective


The purpose of this study was to explore the application of dexmedetomidine (Dex) in cardiopulmonary bypass.
Methods


A total of 60 patients undergoing elective cardiopulmonary bypass were divided into control (C) group and Dex group. In the Dex group, appropriate amount of Dex was added into the membrane lung prefilling solution before anesthesia induction, while those in control group were given normal saline. The levels of mean arterial pressure (MAP) and heart rate (HR) at different times were measured. The levels of cardiac troponin I (CTNI), malondialdehyde (MDA), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α) at different points (T0/T1/T2/T3/T4) in both groups were measured by enzyme-linked immunosorbent assay kits.
Results


The intraoperative and postoperative levels of MAP and HR in the 2 groups were significantly lower than those preoperatively ( P  < .05). The levels of MAP and HR in the Dex group were significantly lower than those of the C group ( P  < .05). The levels of CTNI/MDA/IL-6/TNF-α at different points in both groups were significantly higher than those at T0 ( P  < .05). The serum levels of CTNI, MDA, IL-6, and TNF-α in the Dex group at T1/T2/T3/T4 were significantly lower than those in the C group ( P  < .05). The rate of arrhythmia in the Dex group was significantly lower than that in the C group ( P  < .05).
Conclusion


Dexmedetomidine has a stable effect in cardiopulmonary priming solution.",2020,The levels of CTNI/MDA/IL-6/TNF-α at different points in both groups were significantly higher than those at T0 ( P  < .05).,"['60 patients undergoing elective cardiopulmonary bypass', 'Cardiopulmonary Bypass Prefilling']","['normal saline', 'control (C) group and Dex group', 'dexmedetomidine (Dex', 'Dexmedetomidine']","['serum levels of CTNI, MDA, IL-6, and TNF-α', 'levels of MAP and HR', 'intraoperative and postoperative levels of MAP and HR', 'levels of cardiac troponin I (CTNI), malondialdehyde (MDA), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α) at different points (T0/T1/T2/T3/T4', 'levels of CTNI/MDA/IL-6/TNF-α', 'rate of arrhythmia', 'levels of mean arterial pressure (MAP) and heart rate (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}]",60.0,0.0266874,The levels of CTNI/MDA/IL-6/TNF-α at different points in both groups were significantly higher than those at T0 ( P  < .05).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Xing', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Fulong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Teng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}]",Dose-response : a publication of International Hormesis Society,['10.1177/1559325820939764']
2664,32665381,"Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials.","INTRODUCTION


Left-sided infective endocarditis (IE) is a serious infection with a heavy burden for patients and healthcare system. Oral switch after initial intravenous antibiotic therapy may reduce costs and improve patients' discomfort without increasing unfavourable outcomes. We describe the methodology of two simultaneously conducted open-label randomised trials aiming to assess non-inferiority of oral switch as compared with entirely intravenous antibiotic therapy for the treatment of left-sided IE.
METHODS AND ANALYSIS


Two simultaneous multicentre open-label prospective randomised trials assessing non-inferiority of oral switch during antibiotic treatment as compared with entirely intravenous therapy in patients with left-sided IE are ongoing. One trial is dedicated to left-sided IE caused by multisusceptible staphylococci (Relais Oral Dans le traitement des Endocardites à staphylocoques ou streptOcoques (RODEO)-1) and the other is dedicated to left-sided IE caused by susceptible streptococci or enterococci (RODEO-2). It is planned to randomise 324 patients in each trial after an initial course of at least 10 days of intravenous antibiotic therapy either to continue intravenous antibiotic therapy or to switch to oral antibiotic therapy. The primary outcome is treatment failure within 3 months after the end of antibiotic treatment, a composite outcome defined by all-cause death and/or symptomatic embolic events and/or unplanned valvular surgery and/or microbiological relapse (with the primary pathogen). Secondary outcomes include patient quality of life, echocardiographic outcome, costs and efficiency associated with IE care. Statistical analysis will be performed with a non-inferiority margin of 10% and a one-sided 2.5% type I error.
ETHICS AND DISSEMINATION


Written informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS-Region Centre-Ouest 1, 2015-R26, 23 February 2016). Study findings will be published in peer-reviewed journals and disseminated through presentation at relevant national and international conferences.
TRIAL REGISTRATION NUMBER


EudraCT Number: 2015-002371-16 and NCT02701608; NCT02701595.",2020,"METHODS AND ANALYSIS


Two simultaneous multicentre open-label prospective randomised trials assessing non-inferiority of oral switch during antibiotic treatment as compared with entirely intravenous therapy in patients with left-sided IE are ongoing.",['patients with left-sided IE are ongoing'],"['intravenous antibiotic therapy', 'Oral switch versus standard intravenous antibiotic therapy', 'entirely intravenous antibiotic therapy', 'oral switch during antibiotic treatment']","['treatment failure within 3 months after the end of antibiotic treatment, a composite outcome defined by all-cause death and/or symptomatic embolic events and/or unplanned valvular surgery and/or microbiological relapse (with the primary pathogen', 'patient quality of life, echocardiographic outcome, costs and efficiency associated with IE care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1827151', 'cui_str': 'Left sided infective endocarditis'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0559680', 'cui_str': 'Intravenous antibiotic therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}]",,0.161677,"METHODS AND ANALYSIS


Two simultaneous multicentre open-label prospective randomised trials assessing non-inferiority of oral switch during antibiotic treatment as compared with entirely intravenous therapy in patients with left-sided IE are ongoing.","[{'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lemaignen', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, Centre Hospitalier Régional Universitaire de Tours, Tours, France louis.bernard@univ-tours.fr.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Tattevin', 'Affiliation': 'Service de Maladies Infectieuses et de Réanimation Médicale, Centre Hospitalier Universitaire de Rennes, Rennes, Bretagne, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bru', 'Affiliation': ""Service d'infectiologie et de médecine interne, Centre Hospitalier Annecy-Genevois, Epagny Metz-Tessy, Rhône-Alpes, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Duval', 'Affiliation': 'INSERM Clinical Investigation Center 1425, IAME 1138, Universite Paris Diderot, Sorbonne Paris-Cité, Paris, Île-de-France, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Hoen', 'Affiliation': 'Service de Maladies Infectieuses et Tropicales, CHRU de Nancy, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Brunet-Houdard', 'Affiliation': ""Unité d'Evaluation Médico-Economique, EA7505, Education Ethique, Santé, Centre Hospitalier Régional Universitaire de Tours, Université de Tours, Tours, Centre, France.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Mainardi', 'Affiliation': 'Service de Microbiologie, APHP, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': ""Unité d'Evaluation Médico-Economique, EA7505, Education Ethique, Santé, Centre Hospitalier Régional Universitaire de Tours, Université de Tours, Tours, Centre, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033540']
2665,32665394,Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer.,"INTRODUCTION


Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by the COVID-19 pandemic.
METHODS AND ANALYSIS


The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly study is a pragmatic, stepped-wedge cluster randomised trial examining a Comprehensive ACP Program. The programme combines two complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions). We will implement the programme at 36 oncology clinics across three unique US health systems. Our primary outcome is the proportion of eligible patients with ACP documentation completed in the electronic health record. Our secondary outcomes include resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy. From a subset of our patient population, we will collect surveys and video-based declarations of goals and preferences. We estimate 11 000 patients from the three sites will be enrolled in the study.
ETHICS AND DISSEMINATION


Regulatory and ethical aspects of this trial include Institutional Review Board (IRB) approval via single IRB of record mechanism at Dana-Farber Cancer Institute, Data Use Agreements among partners and a Data Safety and Monitoring Board. We plan to present findings at national meetings and publish the results.
TRIAL REGISTRATION NUMBER


NCT03609177; Pre-results.",2020,"INTRODUCTION


Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers.","['older adults', '11 000 patients from the three sites will be enrolled in the study', 'patients with cancer', 'older patients with cancer', 'older patients with advanced cancer']","['complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions', 'Advance care planning (ACP', 'Advance Care Planning']","['proportion of eligible patients with ACP documentation', 'resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",11000.0,0.103925,"INTRODUCTION


Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers.","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lakin', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA jlakin@partners.org.'}, {'ForeName': 'Elise N', 'Initials': 'EN', 'LastName': 'Brannen', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Department of General Internal Medicine, Boston University School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Lindvall', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gundersen', 'Affiliation': 'Department of Survey and Data Management Core, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Volandes', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-040999']
2666,32665410,Education Research: Online Alzheimer education for high school and college students: A randomized controlled trial.,"OBJECTIVE


Alzheimer disease (AD) risk factors are present throughout the lifespan. This randomized controlled trial evaluated the effectiveness of various online education strategies concerning AD risk reduction and brain health in younger populations.
METHOD


High school and college students were recruited via social media (Facebook and Instagram) to join AlzU.org, an evidence-based education portal, and were randomized to 1 of 4 courses: highly interactive webinar lessons narrated by actor Seth Rogen (celebrity webinar) or a physician (doctor webinar), minimally interactive video lessons with Seth Rogen (celebrity video), or minimally interactive video lessons (control). Surveys were administered at baseline and postcourse. The primary outcome was change in knowledge of AD risk reduction assessed by pre vs post lesson quiz scores. Secondary outcomes included change in awareness of AD research, hopefulness about AD, interest in pursuing health care, willingness to volunteer, and likelihood of recommending AlzU.org.
RESULT


A total of 721 participants joined. A total of 281 (38.9%) completed the course. Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control. Among high school students, no differences were found in quiz scores. In both groups, celebrity webinar, celebrity video, and doctor webinar resulted in greater improvements in awareness that nutrition and exercise may reduce AD risk vs controls. Among college students, celebrity webinar and celebrity video group participants felt more hopeful about the future of AD and more likely to recommend AlzU.org vs doctor webinar and control participants. Among college students, celebrity webinar, celebrity video, and doctor webinar participants were more willing to volunteer for AD causes and pursue health care careers vs controls.
CONCLUSION


Online education involving a celebrity may be an effective strategy for educating college students about AD risk reduction strategies. Further studies are warranted in high school students.",2020,"Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control.","['721 participants joined', 'high school and college students', 'college students, celebrity webinar, celebrity video, and doctor webinar participants', 'younger populations', 'High school and college students were recruited via social media (Facebook and Instagram) to join AlzU.org, an evidence-based education portal']","['various online education strategies concerning AD risk reduction', 'interactive webinar lessons narrated by actor Seth Rogen (celebrity webinar) or a physician (doctor webinar), minimally interactive video lessons with Seth Rogen (celebrity video), or minimally interactive video lessons (control']","['knowledge of AD risk reduction assessed by pre vs post lesson quiz scores', 'quiz score improvements', 'quiz scores', 'celebrity webinar and celebrity video vs doctor webinar and control', 'change in awareness of AD research, hopefulness about AD, interest in pursuing health care, willingness to volunteer, and likelihood of recommending AlzU.org']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",721.0,0.102402,"Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control.","[{'ForeName': 'Nabeel', 'Initials': 'N', 'LastName': 'Saif', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Kellyann', 'Initials': 'K', 'LastName': 'Niotis', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Dominguez', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hodes', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Woodbury', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Amini', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sadek', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Scheyer', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Caesar', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Hristov', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Newman', 'Initials': 'N', 'LastName': 'Knowlton', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Isaacson', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT. rii9004@med.cornell.edu.'}]",Neurology,['10.1212/WNL.0000000000009859']
2667,32665431,Evaluation of stroke thrombectomy including patients where IV thrombolysis is contraindicated or has failed: a randomized trial of two novel thrombectomy devices.,"BACKGROUND


Study was a PROBE design phase II randomized controlled trial (RCT). We assessed trial feasibility and technical efficacy and safety of two novel thrombectomy devices - ERIC (a retriever device) and SOFIA (a distal access catheter) - used alone or in combination depending on operator preference.
METHODS


Four UK neuroscience centers enrolled adults with proximal large artery occlusion (LAO) stroke on imaging where arterial puncture was achievable within 5.5 hours (8.5 hours for posterior circulation) of symptom onset; National Institutes of Health Stroke Scale (NIHSS) ≥6 with limited ischemic change on CT imaging. Randomization was 2:1 into intervention arm (ERIC and/or SOFIA). Patients and core lab were blinded to allocation. Primary outcome was independent core lab adjudication of reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) scale). Secondary outcomes were modified Rankin score (mRS) at 90 and 365 days (independence and shift analysis), 30-day mortality, symptomatic intracranial hemorrhage (sICH), procedural complications and NIHSS change.
RESULTS


Sixty-six patients were enrolled. TICI 2B/3 reperfusion was achieved in 72% in intervention compared with 90% in control arm on intention to treat (ITT) analysis (P=0.2) and 78% compared with 86% on per protocol analysis (P=0.7). Functional independence at 90 days was 40% (intervention) compared with 43% (control) on ITT analysis (P=1.0). sICH rates were low at 0% and 5%, respectively (P=0.3). The 30-day mortality was 9% intervention compared with 14% control (P=0.7).
CONCLUSIONS


Study indicated feasibility of a phase II RCT trial approach for assessing new thrombectomy devices. In a broad LAO stroke population ERIC and SOFIA were not statistically different from control devices. Larger trials are needed.",2020,Functional independence at 90 days was 40% (intervention) compared with 43% (control) on ITT analysis (P=1.0).,"['Four UK neuroscience centers enrolled adults with proximal large artery occlusion (LAO) stroke on imaging where arterial puncture was achievable within 5.5 hours (8.5 hours for posterior circulation) of symptom onset; National Institutes of Health Stroke Scale (NIHSS) ≥6 with limited ischemic change on CT imaging', 'Sixty-six patients were enrolled']",['two novel thrombectomy devices - ERIC (a retriever device) and SOFIA (a distal access catheter) - used alone or in combination depending on operator preference'],"['sICH rates', 'Functional independence', 'modified Rankin score (mRS) at 90 and 365 days (independence and shift analysis), 30-day mortality, symptomatic intracranial hemorrhage (sICH), procedural complications and NIHSS change', 'TICI 2B/3 reperfusion', 'core lab adjudication of reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) scale', '30-day mortality']","[{'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0324426', 'cui_str': 'Retriever'}, {'cui': 'C0445270', 'cui_str': 'Sofia'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}]",66.0,0.355129,Functional independence at 90 days was 40% (intervention) compared with 43% (control) on ITT analysis (P=1.0).,"[{'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'White', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, Tyne & Wear, UK phil.white@ncl.ac.uk.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gregson', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, Tyne & Wear, UK.'}, {'ForeName': 'Elena Adela', 'Initials': 'EA', 'LastName': 'Cora', 'Affiliation': 'Neuroradiology, Capital Health Halifax Infirmary Site, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Dixit', 'Affiliation': 'Neuroradiology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, Tyne & Wear, UK.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Subramanian', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Yogish', 'Initials': 'Y', 'LastName': 'Joshi', 'Affiliation': 'Neuroradiology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Simister', 'Affiliation': 'Consultant Stroke Neurologist UCLH Comprehensive Stroke Service, University College London Faculty of Medical Sciences, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lakey', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, Tyne & Wear, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Maiter', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, Tyne & Wear, UK.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Stroke Medicine, Oxford University, Oxford, Oxfordshire, UK.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2020-016038']
2668,32665432,Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate.,"OBJECTIVES


Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment.
METHODS


Children aged 4-17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1).
RESULTS


Of 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
CONCLUSIONS


Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.",2020,"Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
","['Children aged 4-17\xa0years with polyarticular JIA', 'patients with polyarticular juvenile idiopathic arthritis receiving', 'patients with juvenile idiopathic arthritis (JIA', '171 patients enrolled, 62 (36%) completed the long-term extension']","['adalimumab with or without methotrexate', 'adalimumab', 'placebo']","['Mean JADAS27', 'clinical remission (JADAS27', 'efficacy assessments included JIA American College of Rheumatology (JIA ACR', '27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1', 'JIA ACR 30/50/70/90 responses and JADAS27 LDA', 'Adverse events (AEs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4521004', 'cui_str': 'Polyarticular juvenile idiopathic arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",11.0,0.208291,"Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lovell', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA Daniel.lovell@cchmc.org.""}, {'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Andreas O', 'Initials': 'AO', 'LastName': 'Reiff', 'Affiliation': 'Department of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Jung', 'Affiliation': ""Department of Rheumatology, Children's National Medical Center for Cancer and Immunology Research, Washington, District of Columbia, USA.""}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Jarosova', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Němcová', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mouy', 'Affiliation': 'Pediatric Rheumatology, Univeristé Paris-Descartes and Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Sandborg', 'Affiliation': ""Pediatric Rheumatology, Lucile Packard Children's Hospital at Stanford, Palo Alto, California, USA.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Bohnsack', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Pediatric Rheumatology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elewaut', 'Affiliation': 'Rheumatology, University Hospital Gent, Gent, Belgium.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Gabriel', 'Affiliation': ""Pediatric Rheumatology, Children's Hospital of the King's Daughters, Norfolk, Virginia, USA.""}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Higgins', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Kone-Paut', 'Affiliation': 'Department of Paediatric Rheumatology and CEREMAI, Hôpital De Bicêtre, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, Paris, France.'}, {'ForeName': 'Olcay Y', 'Initials': 'OY', 'LastName': 'Jones', 'Affiliation': 'Pediatric Rheumatology, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Vargová', 'Affiliation': 'Pediatric Rheumatology Unit, Faculty Hospital, Kosice, Slovakia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chalom', 'Affiliation': 'Pediatric-Rheumatology, Saint Barnabas Medical Center, Livingston, New Jersey, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Wouters', 'Affiliation': 'Pediatric Immunology, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lagunes', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI),, Università degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Clinica Pediatrica e Reumatologia-PRINTO, IRCCS Istituto Giannina Gaslini, Genova, Italy.'}]",RMD open,['10.1136/rmdopen-2020-001208']
2669,32665433,"Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study.","OBJECTIVE


To evaluate the effect of guselkumab on enthesitis and dactylitis in a phase II trial of patients with active psoriatic arthritis (PsA).
METHODS


This was a phase II, randomised, placebo-controlled, double-blind trial of adults with active PsA (≥3 swollen and ≥3 tender joints and C reactive protein ≥0.3 mg/dL) despite conventional synthetic disease-modifying anti-rheumatic drug, non-steroidal anti-inflammatory drug, and/or oral corticosteroid therapy. Patients were randomised to subcutaneous injections of guselkumab 100 mg or placebo at weeks 0, 4 and every 8 weeks, with placebo crossover to guselkumab at week 24. Dactylitis was scored on a scale of 0-3 on each digit; enthesitis was assessed using the Leeds Enthesitis Index (0-6). Other assessments included American College of Rheumatology (ACR) and Psoriasis Area and Severity Index responses.
RESULTS


Of 149 randomised patients, 107 patients had enthesitis (mean score=2.7) and 81 patients had dactylitis (mean dactylitis score=5.7) at baseline. Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56. Similar results were observed for the proportions of patients with resolution of enthesitis and dactylitis. At week 56, mean improvements in enthesitis and dactylitis among patients who switched from placebo to guselkumab treatment were similar to those in the guselkumab group. In the guselkumab group, ACR20 responders had greater improvements in enthesitis and dactylitis versus non-responders (week 24).
CONCLUSIONS


At week 24, the guselkumab group had greater mean improvements in enthesitis and dactylitis and greater proportions of patients with resolution of enthesitis and dactylitis versus placebo. ACR20 response was associated with improvements in enthesitis and dactylitis.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT02319759.URL: https://clinicaltrials.gov/ct2/show/NCT02319759; Registered 18 December 2014.",2020,Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56.,"['patients with moderate to severe psoriatic arthritis', 'Of 149 randomised patients, 107 patients had enthesitis (mean score=2.7) and 81 patients had dactylitis (mean dactylitis score=5.7) at baseline', 'adults with active PsA (≥3 swollen and ≥3 tender joints and C reactive protein ≥0.3 mg/dL) despite conventional synthetic disease-modifying anti-rheumatic drug, non-steroidal anti-inflammatory drug, and/or oral corticosteroid therapy', 'patients with active psoriatic arthritis (PsA']","['guselkumab', 'https://clinicaltrials.gov/ct2/show/NCT02319759', 'guselkumab 100 mg or placebo', 'NCT02319759.URL', 'placebo']","['American College of Rheumatology (ACR) and Psoriasis Area and Severity Index responses', 'enthesitis and dactylitis', 'resolution of enthesitis and dactylitis', 'ACR20 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}]",,0.345895,Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56.,"[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington, USA pmease@philipmease.com.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Dennis G', 'Initials': 'DG', 'LastName': 'McGonagle', 'Affiliation': 'Chapel Allerton Hospital, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Brisbane, Australia.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mt Sinai, NewYork, NewYork, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development LLC, La Jolla, California, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Chetan S', 'Initials': 'CS', 'LastName': 'Karyekar', 'Affiliation': 'Janssen Global Services LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Section of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.'}]",RMD open,['10.1136/rmdopen-2020-001217']
2670,32665460,Twelve-month outcomes of community-based differentiated models of multi-month dispensing of antiretroviral treatment among stable HIV-infected adults in Lesotho: a cluster randomized non-inferiority trial.,"BACKGROUND


Lesotho adopted the test and treat approach for HIV treatment in June 2016, which increased antiretroviral treatment (ART) clinic volume. We evaluated community versus facility differentiated models of multi-month dispensing (MMD) of ART among stable HIV-infected adults in Lesotho.
METHODS


Thirty facilities were randomised to three arms, facility 3-monthly ART (3MF) (control), community ART groups (3MC); and 6-monthly community distribution points (6MCD). We estimated risk differences (RD) between arms using population-averaged generalized estimating equations, controlling for baseline imbalances and specifying for clustering. The primary outcome was retention in ART care by intention-to-treat, and virologic suppression as a secondary outcome. (ClinicalTrials.gov: NCT03438370) RESULTS:: 5,336 participants were enrolled, 1,898 3MF, 1,558 3MC and 1,880 in 3MF, 3MC and 6MCD respectively. Retention in ART care was not different across arms and achieved the pre-specified non-inferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD= -0.1% (95% CI: -1.6% to 1.5%), adjusted RD= -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD= -1.2% (95% CI: -2.9% to 0.5%), respectively. After 12 months, 98.6% (n=1,503), 98.1% (n=1,126) and 98.3% (n=1,285) were virally load (VL) suppressed in 3MF, 3MC and 6MCD, respectively. There were no differences in VL between 3MC vs. control, and 6MCD vs. control, risk ratio (RR) = 1.00 (95% CI: 0.98-1.01) and, RR=1.00 (95% CI: 0.98-1.01), respectively.
CONCLUSION


There were no differences in retention and VL suppression for stable HIV-infected participants receiving MMD of ART within community-based differentiated models when compared to the facility-based standard-of-care model.",2020,"Retention in ART care was not different across arms and achieved the pre-specified non-inferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD= -0.1% (95% CI: -1.6% to 1.5%), adjusted RD= -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD= -1.2% (95% CI:","['stable HIV-infected adults in Lesotho', '5,336 participants were enrolled, 1,898 3MF, 1,558 3MC and 1,880 in 3MF, 3MC and 6MCD respectively', 'Thirty facilities']","['facility 3-monthly ART (3MF) (control), community ART groups (3MC); and 6-monthly community distribution points (6MCD']","['VL between 3MC vs. control, and 6MCD vs. control, risk ratio (RR) ', 'retention and VL suppression', 'retention in ART care by intention-to-treat, and virologic suppression']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",5336.0,0.280292,"Retention in ART care was not different across arms and achieved the pre-specified non-inferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD= -0.1% (95% CI: -1.6% to 1.5%), adjusted RD= -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD= -1.2% (95% CI:","[{'ForeName': 'Betty Bawuba', 'Initials': 'BB', 'LastName': 'Tukei', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho (Betty Tukei MPH, MSc, BSc Veronica Makatleho Sejana BSc Lincoln Moletsane Mokoroane BSc Lebelang Sehlabo BA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fatti', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa (Geoffrey Fatti MBChB, MPH Nicoletta Ngorima-Mabhena MBChB, MSc Epidemiology.""}, {'ForeName': 'Appolinaire', 'Initials': 'A', 'LastName': 'Tiam', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, USA (Appolonnaire Tiam MBChB, DipHIVMan, MMed.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ngorima-Mabhena', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa (Geoffrey Fatti MBChB, MPH Nicoletta Ngorima-Mabhena MBChB, MSc Epidemiology.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Tukei', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, USA (Appolonnaire Tiam MBChB, DipHIVMan, MMed.'}, {'ForeName': 'Itumeleng', 'Initials': 'I', 'LastName': 'Tshabalala', 'Affiliation': 'Lesotho Ministry of Health (Itumeleng Tshabalala Diploma in Pharmacy).'}, {'ForeName': 'Veronica Makatleho', 'Initials': 'VM', 'LastName': 'Sejana', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho (Betty Tukei MPH, MSc, BSc Veronica Makatleho Sejana BSc Lincoln Moletsane Mokoroane BSc Lebelang Sehlabo BA.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Muzenda', 'Affiliation': ""Kheth'Impilo AIDS Free Living, Cape Town, South Africa (Geoffrey Fatti MBChB, MPH Nicoletta Ngorima-Mabhena MBChB, MSc Epidemiology.""}, {'ForeName': 'Lincoln Moletsane', 'Initials': 'LM', 'LastName': 'Mokoroane', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho (Betty Tukei MPH, MSc, BSc Veronica Makatleho Sejana BSc Lincoln Moletsane Mokoroane BSc Lebelang Sehlabo BA.'}, {'ForeName': 'Lebelang', 'Initials': 'L', 'LastName': 'Sehlabo', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho (Betty Tukei MPH, MSc, BSc Veronica Makatleho Sejana BSc Lincoln Moletsane Mokoroane BSc Lebelang Sehlabo BA.'}, {'ForeName': 'Thapelo', 'Initials': 'T', 'LastName': 'Maotoe', 'Affiliation': 'Right to Care/EQUIP Health, South Africa (Thapelo Maotoe MBChB, MD Francis Akpan MBchB, MPH Thembi Xulu MB BCh, MPH.'}, {'ForeName': 'Justine Kiwanuka', 'Initials': 'JK', 'LastName': 'Mirembe', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development (Iyiola Faturiyele MBChB, MPH, Justine Kiwanuka Mirembe MBChB, Ian Membe MPH, Thomas Minior MD,MPH).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Membe', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development (Iyiola Faturiyele MBChB, MPH, Justine Kiwanuka Mirembe MBChB, Ian Membe MPH, Thomas Minior MD,MPH).'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Akpan', 'Affiliation': 'Right to Care/EQUIP Health, South Africa (Thapelo Maotoe MBChB, MD Francis Akpan MBchB, MPH Thembi Xulu MB BCh, MPH.'}, {'ForeName': 'Khotso', 'Initials': 'K', 'LastName': 'Maile', 'Affiliation': 'Right to Care/EQUIP Health, Maseru, Lesotho (Betty Tukei MPH, MSc, BSc Veronica Makatleho Sejana BSc Lincoln Moletsane Mokoroane BSc Lebelang Sehlabo BA.'}, {'ForeName': 'Iyiola', 'Initials': 'I', 'LastName': 'Faturiyele', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development (Iyiola Faturiyele MBChB, MPH, Justine Kiwanuka Mirembe MBChB, Ian Membe MPH, Thomas Minior MD,MPH).'}, {'ForeName': 'Thembi', 'Initials': 'T', 'LastName': 'Xulu', 'Affiliation': 'Right to Care/EQUIP Health, South Africa (Thapelo Maotoe MBChB, MD Francis Akpan MBchB, MPH Thembi Xulu MB BCh, MPH.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Minior', 'Affiliation': 'Division of Prevention Care and Treatment, U.S. Agency for International Development (Iyiola Faturiyele MBChB, MPH, Justine Kiwanuka Mirembe MBChB, Ian Membe MPH, Thomas Minior MD,MPH).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Sanne', 'Affiliation': 'Right to Care/EQUIP Health, South Africa (Thapelo Maotoe MBChB, MD Francis Akpan MBchB, MPH Thembi Xulu MB BCh, MPH.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chasela', 'Affiliation': 'Right to Care/EQUIP Health, South Africa (Thapelo Maotoe MBChB, MD Francis Akpan MBchB, MPH Thembi Xulu MB BCh, MPH.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002439']
2671,32665479,A Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity in Type 2 Diabetes: The BEHOLD-8 Controlled Clinical Trial.,"OBJECTIVE


Physical activity is associated with superior health outcomes in patients with type 2 diabetes (T2D), but the majority of T2D patients do not follow physical activity recommendations. The objective of this study was to assess the feasibility and impact of a novel combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity in T2D.
METHODS


This controlled clinical trial compared an 8-week, phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition among 60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 minutes/week). The primary study outcome was feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session). Secondary outcomes were between-group differences in changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps/day), using mixed effects regression models, at 8 and 16 weeks.
RESULTS


Ninety-two percent of PP-MI sessions were completed, and mean participant ratings of ease/utility were 8.5-8.8/10, surpassing a priori benchmarks for feasibility and acceptability. PP-MI participants had small-medium effect size (ES) difference improvements in positive affect compared to MI (8 weeks: estimated mean difference [EMD] 3.07 [SE 1.41], p=.029, ES=.44; 16 weeks: EMD 2.92 [SE 1.73], p=.092, ES=.42). PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
CONCLUSIONS


The PP-MI intervention was feasible and well-accepted. Next-step efficacy studies can more rigorously explore the intervention's effects on physical activity and clinical outcomes.Trial registrationClinicalTrials.gov Registration #NCT03150199.",2020,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","['60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 minutes/week', 'Type 2 Diabetes', 'patients with type 2 diabetes (T2D']","['phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition', 'novel combined positive psychology-motivational interviewing (PP-MI) intervention', 'Positive Psychology-Motivational Interviewing Intervention']","['MVPA', 'feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session', 'changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps/day']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",60.0,0.10928,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Golden', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Massey', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Feig', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Wei-Jean', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gianangelo', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000840']
2672,32665506,Sedoanalgesia Versus Infraclavicular Block for Closed Reduction of Pediatric Forearm Fracture in Emergency Department: Prospective Randomized Study.,"OBJECTIVE


Procedural sedoanalgesia is commonly used in pediatric patients in the emergency department (ED) for interventional procedures, diagnosis, and treatment. However, this method causes serious systemic complications, such as respiratory and cardiac depression. To minimize these complications, ultrasound-guided regional anesthesia methods have been used in recent years. We aimed to compare the use of procedural sedoanalgesia (PSA) and infraclavicular block (ICB) in the pain management of pediatric patients who underwent closed reductions of forearm fractures.
MATERIALS AND METHODS


This prospective, randomized, clinical study included patients aged 3 to 15 years who presented to the ED with forearm fractures. The patients were divided into 2 groups: the procedural sedoanalgesia group (group PSA, n = 30) and ultrasound-guided ICB group (group ICB, n = 30). Pain scores of the patients were evaluated using the Wong-Baker FACES Scale before and during the procedure. Pain scores and parental and operator satisfaction were compared between the groups.
RESULTS


There was no statistical significance in terms of demographic data. The pain scores observed during the procedures were significantly higher in the group PSA than in the group ICB (3.07 ± 1.55 vs 0.47 ± 0.86, respectively; P < 0.001). The parental and operator satisfaction of the ICB group was significantly higher than that of the PSA group (P < 0.001).
CONCLUSIONS


Ultrasound-guided ICB is a safe and effective method in the management of pain during closed reduction of forearm fracture in pediatric patients in EDs. It can be used safely in emergency rooms and has a high level of both parental and operator satisfaction.",2020,"CONCLUSIONS


Ultrasound-guided ICB is a safe and effective method in the management of pain during closed reduction of forearm fracture in pediatric patients in EDs.","['Pediatric Forearm Fracture in Emergency Department', 'pediatric patients in EDs', 'patients aged 3 to 15 years who presented to the ED with forearm fractures', 'pediatric patients in the emergency department (ED', 'pediatric patients who underwent closed reductions of forearm fractures']","['Sedoanalgesia Versus Infraclavicular Block', 'procedural sedoanalgesia group (group PSA, n = 30) and ultrasound-guided ICB', 'procedural sedoanalgesia (PSA) and infraclavicular block (ICB', 'Ultrasound-guided ICB']","['Pain scores and parental and operator satisfaction', 'parental and operator satisfaction', 'Pain scores', 'pain scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1305215', 'cui_str': 'Fracture of forearm'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",30.0,0.0257851,"CONCLUSIONS


Ultrasound-guided ICB is a safe and effective method in the management of pain during closed reduction of forearm fracture in pediatric patients in EDs.","[{'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Karagoz', 'Affiliation': 'From the Department of Emergency Medicine.'}, {'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Tekin', 'Affiliation': 'From the Department of Emergency Medicine.'}, {'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Mehmet Cenk', 'Initials': 'MC', 'LastName': 'Turgut', 'Affiliation': 'Department of Orthopedic Surgery, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ahmet Murat', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Pediatric emergency care,['10.1097/PEC.0000000000002190']
2673,32665528,"Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial.","OBJECTIVES


This randomized, multicenter, placebo-controlled, phase IV study assessed the efficacy and tolerability of onabotulinumtoxinA in patients with overactive bladder.
METHODS


Patients were randomized 1:1 to onabotulinumtoxinA 100 U or placebo. Assessments over 12 weeks included: change from baseline in urinary incontinence (UI) episodes/day; proportions of patients who achieved 100% and 50% or greater reductions in UI episodes/day; proportion of patients using no incontinence pads in the previous 24 hours; and changes from baseline in micturition frequency, nocturia, urgency UI, Incontinence-Quality of Life, King's Health Questionnaire, International Consultation on Incontinence Questionnaire-UI Short Form scores and time to request retreatment.
RESULTS


Significant reductions in UI episodes/day were seen with onabotulinumtoxinA versus placebo within week 1 posttreatment (-2.9 vs -2.0, P = 0.005) through week 12 (coprimary endpoint: -3.5 vs -1.6, P < 0.001). Significantly more onabotulinumtoxinA-treated patients achieved 100% (coprimary endpoint) and 50% or greater reductions in UI episodes/day. Decreases in other urinary symptoms were also seen within 1 week with onabotulinumtoxinA that continued through at least week 12. More onabotulinumtoxinA-treated versus placebo-treated patients required no incontinence pads at weeks 1 to 12, and greater improvements in quality of life measurements were seen. Time to request retreatment was significantly longer with onabotulinumtoxinA versus placebo (30.0 weeks vs 13.1 weeks; P < 0.001). No unexpected safety signals were observed. Urinary tract infection was the most commonly observed adverse event.
CONCLUSIONS


Urinary symptom and quality of life improvements were observed with onabotulinumtoxinA within 1 week of treatment and were sustained for at least 12 weeks.",2020,"RESULTS


Significant reductions in UI episodes/day were seen with onabotulinumtoxinA versus placebo within week 1 posttreatment (-2.9 vs -2.0, P = 0.005) through week 12 (coprimary endpoint:","['patients with overactive bladder', 'Patients With Overactive Bladder and Urinary Incontinence', 'Patients']","['Placebo', 'onabotulinumtoxinA versus placebo', 'onabotulinumtoxinA 100 U or placebo', 'onabotulinumtoxinA', 'placebo']","['Urinary symptom and quality of life improvements', ""micturition frequency, nocturia, urgency UI, Incontinence-Quality of Life, King's Health Questionnaire, International Consultation on Incontinence Questionnaire-UI Short Form scores and time to request retreatment"", 'quality of life measurements', 'urinary symptoms', 'Urinary tract infection', 'efficacy and tolerability', 'Urinary Symptoms and Quality of Life With OnabotulinumtoxinA', 'Time to request retreatment', 'urinary incontinence (UI) episodes/day; proportions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4545794', 'cui_str': 'ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form) score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.28231,"RESULTS


Significant reductions in UI episodes/day were seen with onabotulinumtoxinA versus placebo within week 1 posttreatment (-2.9 vs -2.0, P = 0.005) through week 12 (coprimary endpoint:","[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'McCammon', 'Affiliation': 'From the Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Gousse', 'Affiliation': 'Memorial Hospital Miramar, Miramar, FL.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Kohan', 'Affiliation': 'Advanced Urology Centers of New York, Bethpage, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glazier', 'Affiliation': 'Virginia Urology for Women, Richmond, VA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gruenenfelder', 'Affiliation': 'Orange County Urology Associates, Laguna Hills, CA.'}, {'ForeName': 'Zhanying', 'Initials': 'Z', 'LastName': 'Bai', 'Affiliation': 'Allergan plc, Madison, NJ.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Allergan plc, Marlow, United Kingdom.'}, {'ForeName': 'Douglass', 'Initials': 'D', 'LastName': 'Hale', 'Affiliation': 'Urogynecology Associates, PC, Indianapolis, IN.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000914']
2674,32665816,Comparative evaluation of Stevia and Xylitol chewing gum on salivary Streptococcus mutans count - A pilot study.,"Background


Stevia is a natural sweetener which is used as sugar substitute. It has been suggested that stevia may be anticariogenic. However, there is limited research in this regard. Hence, the present study was designed to assess reduction in  S. mutans  in stevia and xylitol chewing gums. The aim of this study is to evaluate the effectiveness of stevia and xylitol chewing gums on salivary  Streptococcus mutans  count.
Material and Methods


A randomized triple blinded clinical study with a crossover design included twenty healthy children aged 8-13 years with decayed, missing, and filled teeth (dmft)/DMFT index score ≥ 3. Before the test, unstimulated saliva was collected. Children divided into Group I and II were given Stevia and Xylitol chewing gums respectively. Saliva samples were then collected at 15 min (just after spitting) and after 1 h. The amount of  S. mutans  in saliva was evaluated using a selective media (TYCSB). The data were subjected to statistical analysis using statistical software IBM SPSS statistics 20.0 (IBM Corporation, Armonk, NY, USA).
Results


Reduction in  S. mutans  was seen from baseline to 1 hour in both groups in trial and crossover design though intergroup comparison was not statistically significant. There was reduction seen from baseline to 15 minutes and 15 minutes to 1 hour in xylitol and stevia group both in trial and crossover design which was statistically significant.
Conclusions


Stevia containing chewing gum is equally effective to Xylitol chewing gum in reducing salivary  S. mutans  counts.  Key words: Stevia, Xylitol , S. mutans.",2020,"There was reduction seen from baseline to 15 minutes and 15 minutes to 1 hour in xylitol and stevia group both in trial and crossover design which was statistically significant.
","['S. mutans  in stevia and xylitol chewing gums', 'twenty healthy children aged 8-13 years with decayed, missing, and filled teeth (dmft)/DMFT index score ≥ 3']","['stevia and xylitol chewing gums', 'Stevia and Xylitol chewing gums respectively', 'Stevia and Xylitol chewing gum']",['salivary Streptococcus mutans count '],"[{'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",20.0,0.0253612,"There was reduction seen from baseline to 15 minutes and 15 minutes to 1 hour in xylitol and stevia group both in trial and crossover design which was statistically significant.
","[{'ForeName': 'Mitali R', 'Initials': 'MR', 'LastName': 'Shinde', 'Affiliation': 'Post- graduate, D. Y. Patil School of Dentistry, Nerul, Navi- Mumbai.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Winnier', 'Affiliation': 'Associate Professor, D. Y. Patil School of Dentistry, Nerul, Navi-Mumbai.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.55720']
2675,32665817,Evaluating the additive effect of Persica and chlorhexidine mouthwashes on oral health status of children receiving chemotherapy for their hematomalignancy: A randomized clinical trial.,"Background


No definitive protocol has been introduced for treatment or prevention of chemotherapy induced mucositis. The aim of this study was to assess the additive effect of Persica and chlorhexidine on chemotherapy induced mucositis of children with hematomalignancies.
Material and Methods


This randomized clinical trial was performed on 44 children aged 6 to 12 years who were under a similar maintenance chemotherapy protocol for their hematomalignancies. The clinician instructed oral hygiene cares to the patients and their parents and the severity of the mucositis and oral health status of patients were evaluated according to Oral Assessment Guide index. Then, the patients were randomly assigned to one of two experimental groups and were instructed to rinse either with Persica oral drops or normal saline, twice a day for two weeks. Subsequently, the patients in both groups were educated to rinse with chlorhexidine for 30 seconds and avoid eating for an hour. Second and third oral examinations were performed on the 8th and 15th day using the same questionnaire.
Results


Comparing severity of mucositis and oral health status of patients did not show any significant difference between treatment groups in either of examination sessions ( p >0.05). However, both treatment groups showed statistically significant oral health improvement, in terms of mucositis, plaque accumulation and gingival condition, in 14 days following mouthrinses administration ( p <0.05).
Conclusions


Both mouth-rinse combinations were effective on mucositis, plaque and gingival status of children receiving chemotherapy. However, Persica does not seem to pose additional effect on chlorhexidine in decreasing severity of chemotherapy induced mucositis.  Key words: Mucositis, chemotherapy, children, chlorhexidine, Persica.",2020,"However, both treatment groups showed statistically significant oral health improvement, in terms of mucositis, plaque accumulation and gingival condition, in 14 days following mouthrinses administration ( p <0.05).
","['children receiving chemotherapy', 'children with hematomalignancies', '44 children aged 6 to 12 years who were under a similar maintenance chemotherapy protocol for their hematomalignancies', 'children receiving chemotherapy for their hematomalignancy']","['Persica and chlorhexidine mouthwashes', 'chlorhexidine, Persica', 'Persica and chlorhexidine', 'chlorhexidine', 'Persica oral drops or normal saline']","['mucositis, plaque and gingival status', 'oral health improvement', 'oral health status', 'mucositis, plaque accumulation and gingival condition', 'severity of mucositis and oral health status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0991577', 'cui_str': 'Oral drops'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",44.0,0.0402419,"However, both treatment groups showed statistically significant oral health improvement, in terms of mucositis, plaque accumulation and gingival condition, in 14 days following mouthrinses administration ( p <0.05).
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bahrololoomi', 'Affiliation': 'Department of pediatric dentistry, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Sadat-Hashemi', 'Affiliation': 'Department of Pediatrics, Hematology, Oncology and Genetics Research Center, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hassan-Akhavan-Karbassi', 'Affiliation': 'Department of Oral Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Yasamin', 'Initials': 'Y', 'LastName': 'Khaksar', 'Affiliation': 'Department of pediatric dentistry, School of Dentistry, Shiraz University of Medical Sciences and Health Services, Shiraz, Iran.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56104']
2676,32665818,Efficacy of infiltrative local anesthesia and inferior alveolar nerve block in periapical surgery of lower premolars and molars: A preliminary report.,"Background


The aims of this study were: 1) compare the amount of anesthesia used with the anesthetic technique; 2) relate the quantity of anesthesia needed with the level of anxiety of the patient; 3) study the relationship between the anesthetic technique and the level of hemostasis; 4) correlate the amount of anesthesia with patient and tooth dependent variables.
Material and Methods


A randomized controlled trial was designed with two parallel groups according to the anesthetic technique: infiltrative local anesthesia (infiltrative group) and inferior alveolar nerve block (block group). The following variables were collected: sex, age, smoking habits, plaque index, symptoms, signs, position of the tooth and amount of anesthesia. Before surgery, all patients were asked to assess their anxiety on a six-item questionnaire, the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The analysis of the hemorrhage control of aluminum chloride was judged by the surgeon and two examiners independently and recorded it as: 0 (no hemorrhage control), 1 (slight but apparent intermittent bleeding persisted after application of the material), or 2 (complete hemorrhage control).
Results


Twenty patients were included in this preliminary report. The amount of anesthesia used was lower in block group and in less anxious patients, although these results did not reach statistical significance. A relationship was found between the quantity of anesthesia used and a good hemostasis of the bony crypt before the application of the hemostatic agent ( p <.05); and between elderly patients and a lower amount of anesthetic reinforcement ( p <.05).
Conclusions


Based on these preliminary results, we can conclude that no statistical significance difference was found between the amount of anesthesia used and the anesthetic technique or the anxiety. A relationship was found between hemostasis of the bony crypt and the quantity of anesthesia used; and between younger patients and a greater amount of anesthetic reinforcement.  Key words: Anesthesia, anxiety, endodontic surgery, hemostasis, hemostatic agents,periradicular surgery.",2020,"The amount of anesthesia used was lower in block group and in less anxious patients, although these results did not reach statistical significance.","['periapical surgery of lower premolars and molars', 'Twenty patients were included in this preliminary report']","['infiltrative local anesthesia and inferior alveolar nerve block', 'anesthetic technique: infiltrative local anesthesia (infiltrative group) and inferior alveolar nerve block (block group']","['anxiety on a six-item questionnaire, the Amsterdam Preoperative Anxiety and Information Scale (APAIS', 'hemorrhage control of aluminum chloride', 'anesthetic reinforcement']","[{'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0066198', 'cui_str': 'methyl 4-azidophenylacetimidate'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]",20.0,0.0288392,"The amount of anesthesia used was lower in block group and in less anxious patients, although these results did not reach statistical significance.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Menéndez-Nieto', 'Affiliation': 'Master in Oral Surgery and Implant Dentistry, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': 'Chairman of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cervera-Ballester', 'Affiliation': 'Collaborating Professor of the Master in Oral Surgery and Implant Dentistry, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': 'Full Professor of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peñarrocha-Oltra', 'Affiliation': 'Assistant Professor of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56278']
2677,32665855,Nomogram for predicting pathological complete response and tumor downstaging in patients with locally advanced rectal cancer on the basis of a randomized clinical trial.,"Background


Preoperative fluoropyrimidine with radiotherapy was regarded as the standard of care for locally advanced rectal cancer (LARC). The model for predicting pCR in LARC patients was based on standard treatment only. This study aimed to establish a nomogram with pretherapeutic parameters and different neoadjuvant regimens for predicting pathologic complete response (pCR) and tumor downstaging or good response (ypT0-2N0M0) after receiving neoadjuvant treatment in patients with LARC based on a randomized clinical trial.
Methods


Between January 2011 and February 2015, 309 patients with rectal cancer were enrolled from a prospective randomized study (NCT01211210). All pretreatment clinical parameters were collected to build a nomogram for predicting pCR and tumor downstaging. The model was subjected to bootstrap internal validation. The predictive performance of the model was assessed with concordance index (C-index) and calibration plots.
Results


Of the 309 patients, 53 (17.2%) achieved pCR and 132 (42.7%) patients were classified as tumor downstaging with ypT0-2N0M0. Based on the logistic-regression analysis and clinical consideration, tumor length ( P  = 0.005), tumor circumferential extent ( P  = 0.036), distance from the anal verge ( P  = 0.019), and neoadjuvant treatment regimen ( P  < 0.001) showed independent association with pCR following neoadjuvant treatment. The tumor length ( P  = 0.015), tumor circumferential extent ( P  = 0.001), distance from the anal verge ( P  = 0.032), clinical T category ( P  = 0.012), and neoadjuvant treatment regimen ( P  = 0.001) were significantly associated with good tumor downstaging (ypT0-2N0M0). Nomograms were developed to predict the probability of pCR and tumor downstaging with a C-index of 0.802 (95% confidential interval [CI], 0.736-0.867) and 0.730 (95% CI, 0.672-0.784). Internal validation revealed good performance of the calibration plots.
Conclusions


The nomogram provided individual prediction responses to different preoperative treatment for patients with rectal cancer. This model might help physicians in selecting an optimized treatment, but warrants further external validation.",2020,"The tumor length ( P  = 0.015), tumor circumferential extent ( P  = 0.001), distance from the anal verge ( P  = 0.032), clinical T category ( P  = 0.012), and neoadjuvant treatment regimen ( P  = 0.001) were significantly associated with good tumor downstaging (ypT0-2N0M0).","['Methods\n\n\nBetween January 2011 and February 2015', 'patients with rectal cancer', 'locally advanced rectal cancer (LARC', 'patients with LARC based on a randomized clinical trial', 'patients with locally advanced rectal cancer', '309 patients with rectal cancer']",['fluoropyrimidine with radiotherapy'],"['probability of pCR and tumor downstaging with a C-index', 'tumor circumferential extent', 'pathologic complete response (pCR) and tumor downstaging or good response (ypT0-2N0M0', 'tumor length']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",309.0,0.0351058,"The tumor length ( P  = 0.015), tumor circumferential extent ( P  = 0.001), distance from the anal verge ( P  = 0.032), clinical T category ( P  = 0.012), and neoadjuvant treatment regimen ( P  = 0.001) were significantly associated with good tumor downstaging (ypT0-2N0M0).","[{'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Xie', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Hua-Bin', 'Initials': 'HB', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Jia-Yu', 'Initials': 'JY', 'LastName': 'Ling', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Ze-Hua', 'Initials': 'ZH', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lan', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Xiao-Jian', 'Initials': 'XJ', 'LastName': 'Wu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Mei-Jin', 'Initials': 'MJ', 'LastName': 'Huang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Zhi-Yang', 'Initials': 'ZY', 'LastName': 'Zhou', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.'}]",Gastroenterology report,['10.1093/gastro/goz073']
2678,32670169,Dignity Therapy Helps Terminally Ill Patients Maintain a Sense of Peace: Early Results of a Randomized Controlled Trial.,"Introduction:  Dignity Therapy (DT) is a brief, individualized, narrative psychotherapy developed to reduce psychosocial and existential distress, and promote dignity, meaning, and hope in end of life patients. Previous studies have shown that DT was effective in reducing anxiety and depression, and improving dignity-related distress. However, less is known about its efficacy on spiritual well-being. The aim of this study is to contribute to the existing literature by investigating the effects of DT on specific dimensions of spiritual well-being, demoralization and dignity-related distress in a sample of terminally ill patients.  Methods:  A randomized, controlled trial was conducted with 64 terminally ill patients who were randomly assigned to the intervention group (DT + standard palliative care) or the control group (standard palliative care alone). The primary outcome measures were Meaning, Peace, and Faith whereas the secondary outcome measures were (loss of) Meaning and purpose, Distress and coping ability, Existential distress, Psychological distress, and Physical distress. All measures were assessed at baseline (before the intervention), 7-10 and 15-20 days after the baseline assessment. The trial was registered with ClinicalTrials.gov (Protocol Record NCT04256239).  Results:  The MANOVA yielded a significant effect for the Group X Time interaction. ANOVA with repeated measures showed a significant effect of time on peace and a significant Group X Time interaction effect on peace.  Post hoc  comparisons revealed that, while there was a decrease in peace from pre-treatment to follow-up and from post-treatment to follow-up in the control group, there was no such trend in the intervention group.  Discussion:  This study provides initial evidence that patients in the DT intervention maintained similar levels of peace from pre-test to follow-up, whereas patients in the control group showed a decrease in peace during the same time period. We did not find significant longitudinal changes in measures of meaning, faith, loss of meaning and purpose, distress and coping ability, existential, psychological and physical distress. The findings of our study are of relevance in palliative care and suggest the potential clinical utility of DT, since they offer evidence for the importance of this intervention in maintaining peace of mind for terminally ill patients.",2020,"We did not find significant longitudinal changes in measures of meaning, faith, loss of meaning and purpose, distress and coping ability, existential, psychological and physical distress.","['terminally ill patients', '64 terminally ill patients', 'Terminally Ill Patients Maintain a Sense of Peace']","['Dignity Therapy', 'Dignity Therapy (DT', 'DT intervention', 'intervention group (DT + standard palliative care', 'control group (standard palliative care alone', 'DT']","['meaning, faith, loss of meaning and purpose, distress and coping ability, existential, psychological and physical distress', 'Meaning, Peace, and Faith whereas the secondary outcome measures were (loss of) Meaning and purpose, Distress and coping ability, Existential distress, Psychological distress, and Physical distress', 'anxiety and depression, and improving dignity-related distress']","[{'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]","[{'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4704841', 'cui_str': 'Dignity'}]",64.0,0.124274,"We did not find significant longitudinal changes in measures of meaning, faith, loss of meaning and purpose, distress and coping ability, existential, psychological and physical distress.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Iani', 'Affiliation': 'Department of Human Sciences, European University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'De Vincenzo', 'Affiliation': 'Department of Human Sciences, European University of Rome, Rome, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Maruelli', 'Affiliation': 'Psychology Unit, LILT and Center for Oncological Rehabilitation-CERION of Florence, Florence, Italy.'}, {'ForeName': 'Harvey Max', 'Initials': 'HM', 'LastName': 'Chochinov', 'Affiliation': 'Department of Psychiatry, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Ragghianti', 'Affiliation': 'Psychology Unit, LILT and Center for Oncological Rehabilitation-CERION of Florence, Florence, Italy.'}, {'ForeName': 'Sieva', 'Initials': 'S', 'LastName': 'Durante', 'Affiliation': 'U.O. di Cure Palliative, Fondazione Sanità e Ricerca, Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Lombardo', 'Affiliation': 'U.O. di Cure Palliative, Fondazione Sanità e Ricerca, Rome, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01468']
2679,32670170,Study Protocol of Brief Daily Body-Mind-Spirit Practice for Sustainable Emotional Capacity and Work Engagement for Community Mental Health Workers: A Multi-Site Randomized Controlled Trial.,"Background


Given the emotional demanding nature of social services, we developed a brief daily body-mind-spirit (BMS) program and successfully piloted it with workers at elderly services. The proposed study focuses on community mental health workers who are often under chronic stress and vulnerable to burnout.
Methods


The study aims to evaluate the program for fostering sustainable emotional capacity and work engagement for community mental health workers. A multi-site randomized controlled trial design is adopted. All the 24 the Integrated Community Centre for Mental Wellness (ICCMW of Hong Kong will be approached to join this program. Assuming conservatively, 60% ICCWM (14 centers) will respond and participate. At each site, a pair of intervention and control groups will be run. The targeted total sample size is 224. To investigate the course of changes in burnout and engagement, each group will last 6 months, including 3-month intervention and 3-month follow-up. Measures will be taken at monthly intervals.
Discussion


In light of literature and the pilot trial's findings, participants in the Brief Daily BMS intervention group are expected to have a reduced burnout level and a narrowing of range in work engagement during the 3 months intervention. And within the 3 months post-intervention period, a rebound of burnout level and a widening of range in work engagement are expected to be observed in the same group of participants. Hopefully, this study will contribute to the deeper understanding of burnout and work engagement, and shed light on sustainable intervention for emotionally demanding workplaces.
Clinical Trial Registration


The trial has been registered in the Clinical Trials Centre of the University of Hong Kong. HKUCTR-2763 Registered 27 December 2019 - Retrospectively registered, http://www.hkuctr.com/Study/Show/eb930d24e2c647afb7a922055163f24b.",2020,"And within the 3 months post-intervention period, a rebound of burnout level and a widening of range in work engagement are expected to be observed in the same group of participants.","['Community Mental Health Workers', 'community mental health workers who are often under chronic stress and vulnerable to burnout', 'community mental health workers', 'HKUCTR-2763 Registered 27 December 2019 - Retrospectively registered, http://www.hkuctr.com/Study/Show/eb930d24e2c647afb7a922055163f24b']","['Brief Daily Body-Mind-Spirit Practice', 'BMS intervention']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0754745,"And within the 3 months post-intervention period, a rebound of burnout level and a widening of range in work engagement are expected to be observed in the same group of participants.","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Ng', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Herman H M', 'Initials': 'HHM', 'LastName': 'Lo', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Department of Social Work, Hong Kong Baptist University, Kowloon, Hong Kong.'}, {'ForeName': 'Melody H Y', 'Initials': 'MHY', 'LastName': 'Fung', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Amenda M', 'Initials': 'AM', 'LastName': 'Wang', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam, Hong Kong.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01482']
2680,32670196,A Comprehensive Intervention for Promoting Successful Aging Amongst Older People With Diabetes With Below-Normal Cognitive Function-A Feasibility Study.,"Background:  Older people with diabetes have an increased risk for disability and cognitive dysfunction, which may impede self-care capacity. These are not evaluated routinely in current health systems. In the Center for Successful Aging with Diabetes, patients over the age of 60 undergo multi-disciplinary evaluation days and are provided with an integrated (cognitive, physical, nutritional, and medical) treatment plan. Among individuals with below-normal cognitive function, self-adherence to these recommendations poses a challenge. Thus, the aim of this study was to test the feasibility of a multidisciplinary intervention amongst older people with diabetes with below-normal cognitive function and sub-optimal glucose control.  Methods:  Patients with a MoCA score under 26 and A1C >= 7.5% participated in a two-arm intervention: (A) a medical intervention: monthly meetings with a diabetes nurse-educator, supervised by a diabetes specialist and study psychologist during which changes in their pharmacological regimen of glucose, blood pressure, and lipid control were made and (B) a cognitive/physical rehabilitation intervention. This arm consisted of (1) an intensive phase-group meetings which included computerized cognitive training, aerobic, balance, and strength exercise, and group discussions and (2) a monthly consolidation phase. Outcomes included change in A1C, change in strength, balance, and aerobic exercise capacity as well as change in quality of life.  Results:  After 12 months there was a 0.7% reduction in A1C. After 3 months there was a statistically significant improvement in physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go). There was no additional improvement in physical indices between the 3 and 12 month visits. For some of the physical measures, the improvement observed after 3 months persisted partially to the 12-month visit.  Conclusions:  This feasibility study provides preliminary data that support the efficacy of the complex interventions described. The findings suggest that this older population would require an ongoing ""intensive phase"" intervention. Larger prospective randomized trials are needed.",2020,"After 3 months there was a statistically significant improvement in physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go).","['Older people with diabetes', 'older people with diabetes with below-normal cognitive function and sub-optimal glucose control', 'Older People With Diabetes', 'Patients with a MoCA score under 26 and A1C >= 7.5% participated in a two-arm intervention: (A) a']","['medical intervention: monthly meetings with a diabetes nurse-educator, supervised by a diabetes specialist and study psychologist during which changes in their pharmacological regimen of glucose, blood pressure, and lipid control were made and (B) a cognitive/physical rehabilitation intervention', 'multidisciplinary intervention', 'Comprehensive Intervention', 'intensive phase-group meetings which included computerized cognitive training, aerobic, balance, and strength exercise, and group discussions and (2) a monthly consolidation phase']","['physical indices', 'change in A1C, change in strength, balance, and aerobic exercise capacity as well as change in quality of life', 'physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4047815', 'cui_str': 'Below normal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015538', 'cui_str': 'Nurse teacher'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",,0.0189277,"After 3 months there was a statistically significant improvement in physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Natovich', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Gayus', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Azmon', 'Affiliation': 'The Physiotherapy Department, Faculty of Health Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Michal', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Omri', 'Initials': 'O', 'LastName': 'Gury Twito', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Yair', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Raudoi', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Kapra', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cukierman-Yaffe', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00348']
2681,32670199,Basis and Design of a Randomized Clinical Trial to Evaluate the Effect of Jinlida Granules on Metabolic Syndrome in Patients With Abnormal Glucose Metabolism.,"Background:  Metabolic syndrome (MS) is a powerful risk factor for cardiovascular and cerebrovascular diseases. Although lifestyle intervention reduces several of the symptoms of the syndrome and cardiovascular risks, the lifestyle intervention that yields the benefits is restrictive. Jinlida is a Chinese patent medicine that has shown activity in type 2 diabetes, which has been approved in China. Preclinical studies in Jinlida granules support an improved role of abnormal glucose and lipids metabolism as well as reducing weight. Here, we describe the protocol of an ongoing clinical trial investigating a new therapy for metabolic syndrome in patients with abnormal glucose metabolism.  Methods:  This study will enroll 880 subjects (aged 18-70 years) who have metabolic syndromes with abnormal glucose metabolism. All the participants in a double-blind, parallel, randomized, placebo-controlled trial, will receive Jinlida or placebo, orally, 9 g/time, three times daily for 2-4 years period on the basis of lifestyle intervention. The primary outcome measure (Incidence of type 2 diabetes) will be assessed during intervention cycles. Adverse events were monitored. All statistical tests will be performed using a two-sided test, and a  p  ≤ 0.05 (two-sided test) will be considered to be statistically significant results.  Discussion:  Results from this study will provide evidence on whether incorporating oral Jinlida granules treatment into lifestyle intervention can delay or inhibit the development of diabetes mellitus in metabolic syndrome subjects with abnormal glucose metabolism.  Clinical trial registration:  Registered at http://www.chictr.org.cn/enIndex.aspx. Trial registration number: ChiCTR1900023241.",2020,Adverse events were monitored.,"['Patients With Abnormal Glucose Metabolism', '880 subjects (aged 18-70 years) who have metabolic syndromes with abnormal glucose metabolism', 'metabolic syndrome subjects with abnormal glucose metabolism', 'patients with abnormal glucose metabolism']","['Jinlida Granules', 'Jinlida or placebo', 'lifestyle intervention', 'placebo']","['Metabolic Syndrome', 'Incidence of type 2 diabetes', 'abnormal glucose and lipids metabolism', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580546', 'cui_str': 'Blood glucose abnormal'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C4079029', 'cui_str': 'jinlida'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0580546', 'cui_str': 'Blood glucose abnormal'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",880.0,0.325082,Adverse events were monitored.,"[{'ForeName': 'De', 'Initials': '', 'LastName': 'Jin', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}, {'ForeName': 'Shuolong', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiovascularology, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Huailin', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiovascularology, Key Disciplines of State Administration of TCM for Collateral Disease, Shijiazhuang, China.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'An', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Guangyao', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Department of Endocrinology, Heibei Yiling Hospital, Shijiazhuang, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Piao', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Shenzhen Hospital, Guangzhou University of Chinese Medicine, Shenzhen, China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Xiao-Lin', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00415']
2682,32670518,Impressive Continuous Complete Response after Mogamulizumab in a Heavily Pretreated Sézary Syndrome Patient.,"Background


Sézary syndrome (SS) is a rare lymphoproliferative neoplasm, almost incurable outside the setting of allogeneic transplantable patients. The prognosis for relapsed/refractory patients remains poor, as the available drugs confer short-lasting remission. In this setting, the anti-chemokine receptor type 4 (CCR4) monoclonal antibody mogamulizumab demonstrated efficacy in an international, open-label, randomized controlled phase 3 trial (MAVORIC) versus vorinostat.
Case description


A heavily pretreated 57-year-old SS woman (stage IVA) was randomized in the mogamulizumab arm of MAVORIC at our Institution. She quickly achieved a response, but after 30 cycles, she was discontinued from therapy due to cutaneous toxicity. Nevertheless, she is still in complete response (CR).
Conclusions


mogamulizumab is an anti-CCR4 monoclonal antibody that can induce long-lasting response also in very heavily pretreated patients not responding to any previous treatment. The extraordinary characteristic of our patient is that she is still in CR after 2.5 years since treatment discontinuation.",2020,"In this setting, the anti-chemokine receptor type 4 (CCR4) monoclonal antibody mogamulizumab demonstrated efficacy in an international, open-label, randomized controlled phase 3 trial (MAVORIC) versus vorinostat.
",['Case description\n\n\nA heavily pretreated 57-year-old SS woman (stage IVA'],[],[],"[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036920', 'cui_str': 'Sezary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]",[],[],,0.029122,"In this setting, the anti-chemokine receptor type 4 (CCR4) monoclonal antibody mogamulizumab demonstrated efficacy in an international, open-label, randomized controlled phase 3 trial (MAVORIC) versus vorinostat.
","[{'ForeName': 'Ginevra', 'Initials': 'G', 'LastName': 'Lolli', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Casadei', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Argnani', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nanni', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}]",Mediterranean journal of hematology and infectious diseases,['10.4084/MJHID.2020.040']
2683,32670557,"Novel renal biomarkers show that creatine supplementation is safe: a double-blind, placebo-controlled randomized clinical trial.","The aim of this study was to evaluate the impact of creatine supplementation (CS) on renal function in young, healthy, and active subjects. We used a randomized, double-blind, placebo-controlled clinical trial as the study design. Thirty-six healthy male university students were recruited and divided into three groups: group placebo, group G3 (3 g/day of CS), and group G5 (5 g/day of CS). To assess renal function, new kidney biomarkers, kidney injury molecule-1 (KIM-1) and monocyte chemoattractant protein-1 (MCP-1), were quantified. Serum albumin, serum creatinine, serum urea, estimated glomerular filtration rate (eGFR), proteinuria, and albuminuria were also measured. All groups were evaluated at two times: prior CS or placebo (pre) and after 35 days on CS or placebo (post). After 35 days of intervention, all characteristics were maintained without significant difference ( P  > 0.05) between the groups, including serum creatinine, eGFR, and more sensitive kidney biomarker concentrations (KIM-1 and MCP-1). The paired analysis showed that the supplemented groups (G3 and 5G) had increased serum creatinine and decreased eGFR levels ( P  < 0.05). However, the values were still within the normal reference range. In conclusion, the results of renal function evaluation did not show any difference between the evaluated groups. Increased serum creatinine and decreased eGFR levels in CS groups can be explained by increased creatine stores and metabolism, since creatinine is a by-product of creatine metabolism. These findings indicate that the use of CS at doses of 3 g and 5 g/day for a short period (35 days) is safe and did not impair the kidneys or renal function in young healthy subjects.",2020,"After 35 days of intervention, all characteristics were maintained without significant difference ( P  > 0.05) between the groups, including serum creatinine, eGFR, and more sensitive kidney biomarker concentrations (KIM-1 and MCP-1).","['young, healthy, and active subjects', 'young healthy subjects', 'Thirty-six healthy male university students']","['CS or placebo', 'creatine supplementation', 'creatine supplementation (CS', 'placebo']","['renal function', 'Increased serum creatinine and decreased eGFR levels', 'renal function evaluation', 'renal function, new kidney biomarkers, kidney injury molecule-1 (KIM-1) and monocyte chemoattractant protein-1', 'serum creatinine and decreased eGFR levels', 'serum creatinine, eGFR, and more sensitive kidney biomarker concentrations (KIM-1 and MCP-1', 'Serum albumin, serum creatinine, serum urea, estimated glomerular filtration rate (eGFR), proteinuria, and albuminuria', 'kidneys or renal function']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0700225', 'cui_str': 'Serum creatinine raised'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",36.0,0.23225,"After 35 days of intervention, all characteristics were maintained without significant difference ( P  > 0.05) between the groups, including serum creatinine, eGFR, and more sensitive kidney biomarker concentrations (KIM-1 and MCP-1).","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'de Oliveira Vilar Neto', 'Affiliation': 'Post-Graduate Program in Medical Sciences, Federal University of Ceará, Alexandre Baraúna street, 949-Rodolfo Teófilo, Fortaleza 60430-160, CE, Brazil.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'da Silva', 'Affiliation': 'Physical Education and Sports Institute, Federal University of Ceará, Mister Hull Avenue, Sports Park, Block 320, Pici Ccampus, Fortaleza 60455-760, CE, Brazil.'}, {'ForeName': 'Gdayllon Cavalcante', 'Initials': 'GC', 'LastName': 'Meneses', 'Affiliation': 'Post-Graduate Program in Medical Sciences, Federal University of Ceará, Alexandre Baraúna street, 949-Rodolfo Teófilo, Fortaleza 60430-160, CE, Brazil.'}, {'ForeName': 'Daniel Vieira', 'Initials': 'DV', 'LastName': 'Pinto', 'Affiliation': 'Post-Graduate Program in Medical Sciences, Federal University of Ceará, Alexandre Baraúna street, 949-Rodolfo Teófilo, Fortaleza 60430-160, CE, Brazil.'}, {'ForeName': 'Luciana Catunda', 'Initials': 'LC', 'LastName': 'Brito', 'Affiliation': 'Physical Education and Sports Institute, Federal University of Ceará, Mister Hull Avenue, Sports Park, Block 320, Pici Ccampus, Fortaleza 60455-760, CE, Brazil.'}, {'ForeName': 'Said Goncalves', 'Initials': 'SG', 'LastName': 'da Cruz Fonseca', 'Affiliation': 'Department of Pharmacy and Clinical Analysis, Federal University of Ceará, Pastor Samuel Munguba street, 1210 Rodolfo Teófilo, Fortaleza 60430-372, CE, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'de Sousa Alves', 'Affiliation': 'Department of Pharmacy and Clinical Analysis, Federal University of Ceará, Pastor Samuel Munguba street, 1210 Rodolfo Teófilo, Fortaleza 60430-372, CE, Brazil.'}, {'ForeName': 'Alice Maria Costa', 'Initials': 'AMC', 'LastName': 'Martins', 'Affiliation': 'Department of Pharmacy and Clinical Analysis, Federal University of Ceará, Pastor Samuel Munguba street, 1210 Rodolfo Teófilo, Fortaleza 60430-372, CE, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'de Oliveira Assumpção', 'Affiliation': 'Physical Education and Sports Institute, Federal University of Ceará, Mister Hull Avenue, Sports Park, Block 320, Pici Ccampus, Fortaleza 60455-760, CE, Brazil.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'De Francesco Daher', 'Affiliation': 'Post-Graduate Program in Medical Sciences, Federal University of Ceará, Alexandre Baraúna street, 949-Rodolfo Teófilo, Fortaleza 60430-160, CE, Brazil.'}]",Toxicology research,['10.1093/toxres/tfaa028']
2684,32670565,"The effect of tourniquet uses on total blood loss, early function, and pain after primary total knee arthroplasty: a prospective, randomized controlled trial.","Aims


The aim of this study was to examine whether tourniquet use can improve perioperative blood loss, early function recovery, and pain after primary total knee arthroplasty (TKA) in the setting of multiple-dose intravenous tranexamic acid.
Methods


This was a prospective, randomized clinical trial including 180 patients undergoing TKA with multiple doses of intravenous tranexamic acid. One group was treated with a tourniquet during the entire procedure, the second group received a tourniquet during cementing, and the third group did not receive a tourniquet. All patients received the same protocol of intravenous tranexamic acid (20 mg/kg) before skin incision, and three and six hours later (10 mg/kg). The primary outcome measure was perioperative blood loss. Secondary outcome measures were creatine kinase (CK), CRP, interleukin-6 (IL-6), visual analogue scale (VAS) pain score, limb swelling ratio, quadriceps strength, straight leg raising, range of motion (ROM), American Knee Society Score (KSS), and adverse events.
Results


The mean total blood loss was lowest in the no-tourniquet group at 867.32 ml (SD 201.11), increased in the limited-tourniquet group at 1024.35 ml (SD 176.35), and was highest in the tourniquet group at 1,213.00 ml (SD 211.48). The hidden blood loss was lowest in the no-tourniquet group (both p < 0.001). There was less mean intraoperative blood loss in the tourniquet group (77.48 ml (SD 24.82)) than in the limited-tourniquet group (137.04 ml (SD 26.96)) and the no-tourniquet group (212.99 ml (SD 56.35); both p < 0.001). Patients in the tourniquet group showed significantly higher levels of muscle damage and inflammation biomarkers such as CK, CRP, and IL-6 than the other two groups (p < 0.05). Outcomes for VAS pain scores, limb swelling ratio, quadriceps strength, straight leg raising, ROM, and KSS were significantly better in the no-tourniquet group at three weeks postoperatively (p < 0.05), but there were no significant differences at three months. No significant differences were observed among the three groups with respect to transfusion rate, thrombotic events, or the length of hospital stay.
Conclusion


Patients who underwent TKA with multiple doses of intravenous tranexamic acid but without a tourniquet presented lower total blood loss and hidden blood loss, and they showed less postoperative inflammation reaction, less muscle damage, lower VAS pain score, and better early knee function. Our results argue for not using a tourniquet during TKA.Cite this article:  Bone Joint Res  2020;9(6):322-332.",2020,The hidden blood loss was lowest in the no-tourniquet group (both p < 0.001).,"['180 patients undergoing TKA with multiple doses of intravenous', 'after primary total knee arthroplasty']","['tourniquet during cementing, and the third group did not receive a tourniquet', 'tranexamic acid', 'intravenous tranexamic acid']","['levels of muscle damage and inflammation biomarkers such as CK, CRP, and IL-6', 'VAS pain scores, limb swelling ratio, quadriceps strength, straight leg raising, ROM, and KSS', 'mean intraoperative blood loss', 'creatine kinase (CK), CRP, interleukin-6 (IL-6), visual analogue scale (VAS) pain score, limb swelling ratio, quadriceps strength, straight leg raising, range of motion (ROM), American Knee Society Score (KSS), and adverse events', 'hidden blood loss', 'perioperative blood loss, early function recovery, and pain', 'perioperative blood loss', 'total blood loss and hidden blood loss', 'transfusion rate, thrombotic events, or the length of hospital stay', 'mean total blood loss', 'total blood loss, early function, and pain', 'postoperative inflammation reaction, less muscle damage, lower VAS pain score, and better early knee function']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0158369', 'cui_str': 'Swelling of limb'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",180.0,0.116305,The hidden blood loss was lowest in the no-tourniquet group (both p < 0.001).,"[{'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Releken', 'Initials': 'R', 'LastName': 'Yeersheng', 'Affiliation': 'Department of Orthopedics, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xue-Wen', 'Initials': 'XW', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopedics, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Ya-Yi', 'Initials': 'YY', 'LastName': 'Xia', 'Affiliation': 'Department of Orthopedics, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Peng-De', 'Initials': 'PD', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopedics, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wen-Ji', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, The First Hospital of Lanzhou University, Lanzhou, China.'}]",Bone & joint research,['10.1302/2046-3758.96.BJR-2019-0180.R3']
2685,32670597,Volunteer-led behavioural activation to reduce depression in residential care: a feasibility study.,"Objectives


Symptoms of depression are highly prevalent and under-treated in residential aged care facilities. Behavioural activation is a simple, cost-effective psychosocial intervention that might be appropriate to help reduce depression and improve well-being in this setting. The purpose of this study was to investigate the feasibility and efficacy of an 8-week, volunteer-led behavioural activation intervention designed for depressed aged care residents.
Method


This feasibility study employed a single-arm design, where outcomes were measured at baseline, post-intervention and 3-month follow-up. Aged care residents with depressive symptoms were invited to participate, and healthy volunteers were trained to deliver the intervention. Intervention feasibility was assessed on six a priori-determined domains. Depression, anxiety and flourishing were included as outcomes using intention-to-treat analysis.
Result


Seventeen aged care residents with depressive symptoms and 13 volunteers were successfully recruited within the expected 6-month timeframe. Both residents and volunteers were satisfied with the intervention (7/8), and there was a high (87%) completion rate. The intervention was associated with a large and statistically significant reduction in resident depressive symptoms,  d  = - 1.14, with the effect increasing to  d  = 2.82 when comparing baseline to 3-month follow-up. Anxiety reduced from mild symptoms at baseline mean =  6 .17 (5.12) to the subclinical range post-intervention, mean = 3.53 (4.29) ( g  = 0.61,  p  = 0.03).
Conclusion


This 8-week volunteer-led behavioural activation intervention was found to be feasible and acceptable to depressed aged care residents. The intervention was effective in ameliorating depression. A larger randomized controlled trial is warranted.",2020,"The intervention was associated with a large and statistically significant reduction in resident depressive symptoms,  d  = - 1.14, with the effect increasing to  d  =","['Aged care residents with depressive symptoms were invited to participate, and healthy volunteers', 'depressed aged care residents', 'Seventeen aged care residents with depressive symptoms and 13 volunteers were successfully recruited within the expected 6-month timeframe']","['behavioural activation intervention', 'Volunteer-led behavioural activation', 'volunteer-led behavioural activation intervention']","['Depression, anxiety and flourishing', 'Anxiety reduced from mild symptoms', 'feasibility and efficacy', 'resident depressive symptoms', 'ameliorating depression']","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0458717,"The intervention was associated with a large and statistically significant reduction in resident depressive symptoms,  d  = - 1.14, with the effect increasing to  d  =","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bryant', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, 12th Floor, Redmond Barry Building, Parkville, VIC Australia.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, 12th Floor, Redmond Barry Building, Parkville, VIC Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Polacsek', 'Affiliation': 'National Ageing Research Institute, Parkville, VIC Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Batchelor', 'Affiliation': 'National Ageing Research Institute, Parkville, VIC Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Capon', 'Affiliation': 'National Ageing Research Institute, Parkville, VIC Australia.'}, {'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Dow', 'Affiliation': 'National Ageing Research Institute, Parkville, VIC Australia.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00640-y']
2686,32670779,Testing a school-based program to promote digital health literacy and healthy lifestyle behaviours in intermediate elementary students: The Learning for Life program.,"Promoting digital health literacy and healthy lifestyle behaviours in children can lead to positive long-term health outcomes and prevent chronic diseases. However, there are few school-based interventions promoting this education to intermediate elementary students. The objective of this study was to test the effectiveness of a novel intervention to increase students' digital health literacy and health knowledge. Learning for Life is a classroom-based education program, developed for grade 4-7 students and delivered by teachers over six weeks. Three Canadian schools were recruited to deliver the intervention in 2018. This study had a pre-post design and no control group. Students' self-reported digital health literacy and healthy lifestyle behaviours were measured at pre-intervention (n = 126), post-intervention (n = 119), and two-month follow-up (n = 104). Students at pre-intervention had a mean (SD) age of 10.98 (0.56) years (57.1% females). Almost all (97%) students had unsupervised access to the Internet through a computer or smartphone. From pre- to post-intervention, students' digital health literacy increased (p = 0.009), but decreased from post-intervention to follow-up (p < 0.001). Post-intervention, the majority of students could identify at least one healthy behaviour (e.g., exercising one hour/day) and reported making at least one healthy change in their lives (e.g., eating more fruits/vegetables). This study demonstrated that the Learning for Life intervention can improve intermediate elementary students' digital health literacy over the short-term and help them learn and retain healthy lifestyle knowledge and behaviours. These findings affirm the need for interventions promoting digital healthy literacy and healthy lifestyle behaviours for this age group.",2020,Promoting digital health literacy and healthy lifestyle behaviours in children can lead to positive long-term health outcomes and prevent chronic diseases.,"['intermediate elementary students', 'Students at pre-intervention had a mean (SD) age of 10.98 (0.56) years (57.1% females', 'Three Canadian schools']","['post-intervention', 'novel intervention', 'school-based program to promote digital health literacy and healthy lifestyle behaviours']","[""students' digital health literacy and health knowledge"", 'digital health literacy', ""Students' self-reported digital health literacy and healthy lifestyle behaviours""]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0215773,Promoting digital health literacy and healthy lifestyle behaviours in children can lead to positive long-term health outcomes and prevent chronic diseases.,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Hyman', 'Affiliation': 'Digital Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, The University of British Columbia, 818 West 10th Avenue, Vancouver, BC V5Z 1M9, Canada.'}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': 'Digital Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, The University of British Columbia, 818 West 10th Avenue, Vancouver, BC V5Z 1M9, Canada.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Jamin', 'Affiliation': 'Digital Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, The University of British Columbia, 818 West 10th Avenue, Vancouver, BC V5Z 1M9, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Novak Lauscher', 'Affiliation': 'Digital Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, The University of British Columbia, 818 West 10th Avenue, Vancouver, BC V5Z 1M9, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Stacy', 'Affiliation': 'Digital Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, The University of British Columbia, 818 West 10th Avenue, Vancouver, BC V5Z 1M9, Canada.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Kasten', 'Affiliation': 'Community Nutrition Services, Squamish Community Health Centre, Vancouver Coastal Health, PO Box 220 1140 Hunter Place, Squamish, BC V8B 0A2, Canada.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': 'Digital Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, The University of British Columbia, 818 West 10th Avenue, Vancouver, BC V5Z 1M9, Canada.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101149']
2687,32670822,The synergistic effect of  Citrus bergamia  and  Cynara cardunculus  extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease.,"Background and aim


Non-Alcoholic Fatty Liver Disease (NAFLD) represents a risk factor for cardiovascular diseases. NAFLD is worsened by the simultaneous occurrence of type 2 diabetes mellitus (T2DM) causing an enhancement of inflammatory and fibrotic processes. Although insulin resistance appears the link between NAFLD and T2DM, current pharmacological treatments of T2DM failed to produce relevant benefits in preventing T2DM-related liver dysfunction. In this randomized, double blind, placebo-controlled clinical study, we evaluated the effect of Bergacyn, an innovative formulation originating from the combination of Bergamot Polyphenolic Fraction (BPF) and  Cynara cardunculus  (CyC).
Experimental procedure


80 adult patients with a history of at least 12 months of T2DM and NAFLD received orally BPF (300 mg/daily) Cyc (300 mg/daily), separately or formulated in combination 50/50% (Bergacyn; 300 mg/daily), or placebo all containing 300 mg of bergamot albedo fibers micronized and co-grinded as excipients.
Results and conclusion


Serum measurements and liver ultrasound analyses showed that concomitant administration of BPF and CyC produced significant improvement of NAFLD biomarkers in patients with T2DM. This effect was associated with a substantial reduction of oxidative stress/inflammatory biomarkers, thus contributing to a significant improvement of NO-mediated reactive vasodilation. Furthermore, the effect of Bergacyn showed a synergistic effect of both extracts, thus suggesting that this peculiar formulation represents a novel therapeutic strategy to counteract vascular inflammation and endothelial dysfunction in patients suffering from T2DM and NAFLD. Further studies in larger cohort of diabetic patients are required to better identify the potential of Bergacyn on metabolic disorders accompanying T2DM and NAFLD.",2020,Serum measurements and liver ultrasound analyses showed that concomitant administration of BPF and CyC produced significant improvement of NAFLD biomarkers in patients with T2DM.,"['Alcoholic Fatty Liver Disease (NAFLD', 'non-alcoholic fatty liver disease', '80 adult patients with a history of at least 12 months of T2DM and NAFLD received', 'larger cohort of diabetic patients', 'patients suffering from T2DM and NAFLD', 'patients with T2DM']","['NAFLD', 'Bergamot Polyphenolic Fraction (BPF) and  Cynara cardunculus  (CyC', 'Bergacyn', 'orally BPF', 'placebo all containing 300\xa0mg of bergamot albedo fibers micronized and co-grinded as excipients', 'placebo']","['NAFLD biomarkers', 'vascular inflammation and oxidative stress', 'oxidative stress/inflammatory biomarkers']","[{'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0997028', 'cui_str': 'Cardoon'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0015237', 'cui_str': 'Pharmaceutical excipient'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",80.0,0.0665834,Serum measurements and liver ultrasound analyses showed that concomitant administration of BPF and CyC produced significant improvement of NAFLD biomarkers in patients with T2DM.,"[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Musolino', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gliozzi', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bombardelli', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Nucera', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carresi', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Maiuolo', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Mollace', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Paone', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bosco', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Scarano', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Scicchitano', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Macrì', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ruga', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Maria Caterina', 'Initials': 'MC', 'LastName': 'Zito', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Palma', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Santo', 'Initials': 'S', 'LastName': 'Gratteri', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ragusa', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Volterrani', 'Affiliation': 'San Raffaele IRCCS, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'San Raffaele IRCCS, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mollace', 'Affiliation': 'Institute of Research for Food Safety & Health, Department of Health Sciences, University ""Magna Graecia"" of Catanzaro, Nutramed Scarl and, Italy.'}]",Journal of traditional and complementary medicine,['10.1016/j.jtcme.2020.02.004']
2688,32670911,Evaluation and Comparison of Caries Excavation Efficacy of Three Different Burs: A Micro-computed Tomographic-assisted Study.,"Aims and Objectives


The aim of this study was to evaluate the effectiveness of three different caries excavation methods using micro-computed tomography (micro-CT).
Materials and Methods


Fifteen freshly extracted human molar teeth with occlusal dentinal caries were selected. The teeth were sectioned longitudinally into two halves and were randomly divided into three groups ( n  = 10) depending on the caries removal technique: Group 1: tungsten carbide (TC) bur, Group 2: cerabur (CB), and Group 3: Excavus (EX) tipEX). A preoperative micro-CT scan of all the samples was taken. The caries excavation procedures were carried out followed by postoperative micro-CT scan. The preoperative and postoperative scans of each tooth were analyzed for caries removal effectiveness (CRE), mineral density (MD), and minimal invasiveness potential (MIP) using Avizo 9.4 software (Thermo Fisher Scientific, Germany). Statistical analysis was conducted by applying three-way analysis of variance and independent sample  t -test using the Statistical Package for the Social Sciences software, version 20.0 (IBM Corporation, USA).
Results


Among the three groups, the TC group had the smallest RC/IC (residual caries/initial caries) ratio, highest mean MD at the cavity floor, and highest MIP. The EX group significantly had the highest RC/IC, lowest mean MD, and lowest MIP. Both the CRE and MIP parameters of CB group were acceptable (RC/IC = 0.08, mean MD = 1.09g/cm 3 , and MIP = 1.09).
Conclusion


As compared with the three excavation methods, CBs can be considered as an alternative to TC burs because of its MIP and complete removal of infected carious dentin.",2020,"Among the three groups, the TC group had the smallest RC/IC (residual caries/initial caries) ratio, highest mean MD at the cavity floor, and highest MIP.",['Materials and Methods\n\n\nFifteen freshly extracted human molar teeth with occlusal dentinal caries'],"['caries removal technique: Group 1: tungsten carbide (TC) bur, Group 2: cerabur (CB), and Group 3: Excavus (EX) tipEX', 'micro-computed tomography (micro-CT', 'Three Different Burs']","['highest RC/IC, lowest mean MD, and lowest MIP', 'caries removal effectiveness (CRE), mineral density (MD), and minimal invasiveness potential (MIP', 'Caries Excavation Efficacy', 'smallest RC/IC']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0077514', 'cui_str': 'tungsten carbide'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",15.0,0.0163873,"Among the three groups, the TC group had the smallest RC/IC (residual caries/initial caries) ratio, highest mean MD at the cavity floor, and highest MIP.","[{'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Vusurumarthi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Saint Joseph Dental College and Hospital, Eluru, Andhra Pradesh, India.'}, {'ForeName': 'Srinidhi V', 'Initials': 'SV', 'LastName': 'Ballullaya', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Saint Joseph Dental College and Hospital, Eluru, Andhra Pradesh, India.'}, {'ForeName': 'Shankarappa', 'Initials': 'S', 'LastName': 'Pushpa', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Saint Joseph Dental College and Hospital, Eluru, Andhra Pradesh, India.'}, {'ForeName': 'Venkata Ramya K', 'Initials': 'VRK', 'LastName': 'Veluvarti', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Saint Joseph Dental College and Hospital, Eluru, Andhra Pradesh, India.'}, {'ForeName': 'Pramod R', 'Initials': 'PR', 'LastName': 'Loka', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Saint Joseph Dental College and Hospital, Eluru, Andhra Pradesh, India.'}, {'ForeName': 'Pavan K', 'Initials': 'PK', 'LastName': 'Galla', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Saint Joseph Dental College and Hospital, Eluru, Andhra Pradesh, India.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_133_19']
2689,32670937,Effectiveness of oral exercise on oral function among the elderly.,"Purpose


To evaluate the effectiveness of oral exercise on oral function among the elderly at a selected old age home in Chennai.
Research Design


The present study adopted a one-group pretest and posttest (preexperimental) design.
Methods


Participants received intervention ""oral exercise"" which comprised of exercises for expression muscles (orbicularis oculi, buccinator and orbicularis oris), tongue, salivary glands, and swallowing. The pre- and posttests included assessment of oral function (dry mouth symptoms, amount of salivary pH, salivary secretion, size of mouth opening, halitosis, and oral motor function) using summated xerostomia inventory, spitting into a measuring container for 10 min, pH meter, Vernier caliper, organoleptic test, and Sunnybrook facial grading system, respectively.
Results


Using nonprobability convenience sampling technique, a total of 48 older people living in an old age home who met the inclusion and dental screening criteria were recruited. There was a statistically considerable difference noted in the mean scores of the dry mouth symptoms ( t  = 11.88), amount of salivary secretions ( t  = 17.05), salivary pH ( t  = 8.68), size of mouth opening ( t  = 14.76), halitosis ( t  = 13.13), and oral motor function ( t  = 11.52) at  P  <.001 before and after oral exercise among the elderly.
Conclusion


Oral exercise as a self-regulating intervention can efficiently promote oral health of older people.",2020,"There was a statistically considerable difference noted in the mean scores of the dry mouth symptoms ( t  = 11.88), amount of salivary secretions ( t  = 17.05), salivary pH ( t  = 8.68), size of mouth opening ( t  = 14.76), halitosis ( t  = 13.13), and oral motor function ( t  = 11.52) at  P  <.001 before and after oral exercise among the elderly.
","['elderly', 'elderly at a selected old age home in Chennai.\nResearch Design', '48 older people living in an old age home who met the inclusion and dental screening criteria were recruited', 'older people']","['oral exercise', 'intervention ""oral exercise"" which comprised of exercises for expression muscles (orbicularis oculi, buccinator and orbicularis oris), tongue, salivary glands, and swallowing']","['amount of salivary secretions', 'size of mouth opening', 'mean scores of the dry mouth symptoms', 'oral function', 'oral motor function', 'oral function (dry mouth symptoms, amount of salivary pH, salivary secretion, size of mouth opening, halitosis, and oral motor function) using summated xerostomia inventory, spitting into a measuring container for 10 min, pH meter, Vernier caliper, organoleptic test, and Sunnybrook facial grading system, respectively', 'salivary pH']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019870', 'cui_str': 'Old Age Homes'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224122', 'cui_str': 'Orbicularis oculi muscle structure'}, {'cui': 'C0224121', 'cui_str': 'Structure of buccinator muscle'}, {'cui': 'C0224147', 'cui_str': 'Orbicularis oris muscle structure'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C1629487', 'cui_str': 'Interincisor distance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0563145', 'cui_str': 'Oral motor functions'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0232515', 'cui_str': 'Spitting'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0180098', 'cui_str': 'Container'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0182229', 'cui_str': 'pH meter'}, {'cui': 'C0175720', 'cui_str': 'Caliper'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",48.0,0.0321584,"There was a statistically considerable difference noted in the mean scores of the dry mouth symptoms ( t  = 11.88), amount of salivary secretions ( t  = 17.05), salivary pH ( t  = 8.68), size of mouth opening ( t  = 14.76), halitosis ( t  = 13.13), and oral motor function ( t  = 11.52) at  P  <.001 before and after oral exercise among the elderly.
","[{'ForeName': 'B Thanga', 'Initials': 'BT', 'LastName': 'Raj', 'Affiliation': 'Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sreelekha', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manjula', 'Affiliation': 'Department of Nursing Foundation, Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Porur, Chennai, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_899_19']
2690,32671131,Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19.,"Background


We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients.
Methods


In this single-center, randomized, and open-label trial, mild patients with polymerase chain reaction (PCR)-confirmed COVID-19 were enrolled in Shanghai, China. Participants were randomized to receive DRV/c for 5 days on the top of interferon alpha 2b inhaling or interferon alpha 2b inhaling alone. The primary end point was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population (clinicaltrials.gov: NCT04252274).
Results


From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2 ± 2.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment. The participants were randomized (range) at 4 (2-5) days after onset of symptoms. The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups ( P  = .72), respectively. The viral clearance rate at day 3 was 20% (3/15) in both study groups, while the number increased to 26.7% (4/15) in the DRV/c group and remained 20% (3/15) in the control group at day 5. Fourteen days after randomization, 1 participant in the DRV/c group progressed to critical illness and discontinued DRV/c, while all the patients in the control group were stable ( P  = 1.0). The frequencies of adverse events in the 2 groups were comparable.
Conclusions


Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.",2020,"The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups ( P  = .72), respectively.","['From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2\u2005±\u20052.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment', 'treating COVID-19 patients', 'mild patients with polymerase chain reaction (PCR)-confirmed COVID-19 were enrolled in Shanghai, China']","['interferon alpha 2b inhaling or interferon alpha 2b inhaling alone', 'darunavir/cobicistat (DRV/c']","['critical illness and discontinued DRV/c', 'virological clearance rate of oropharyngeal swabs', 'tolerated', 'Antiviral Activity and Safety', 'frequencies of adverse events', 'antiviral activity and safety', 'viral clearance rate', 'proportion of negative PCR results', 'proportion of negative conversion']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}]","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",30.0,0.211463,"The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups ( P  = .72), respectively.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Department of Tuberculosis, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Qingnian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Traditional Chinese Medicine, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Department of Infectious Diseases, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Tuberculosis, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Cardiovascular Diseases, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Shuibao', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Yingzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical Center, Shanghai, China.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa241']
2691,32671185,The effect of prophylactic carvedilol on subclinical left ventricular dysfunction after 1 cycle FAC chemotherapy in breast cancer patients.,"Background


Despite its efficacy, FAC regimen may cause fatal cardiotoxicity. Carvedilol may also exert additional antioxidant effects. This study aimed to assess the effect of carvedilol in preventing decline of left ventricular function in breast cancer patients receiving FAC regimen chemotherapy.
Methods


The study was a quasi-experimental study. The study subjects were consisted of breast cancer patients currently receiving post-first cycle FAC chemotherapy regimen in period of March - May 2019. The study subjects were divided into 2 groups: control and intervention group. In intervention groups, the patients consumed up titrated carvedilol with initial dose of 2 × 6.25 mg daily, follow-up echocardiography was performed for the patients in order to assess GLS score of left ventricle.
Result


Eighty patients were enrolled to the study, with each group consisted of 40 patients. Patient baseline characteristics were not significantly different between both groups. Left ventricular function was assessed using speckle tracking echocardiography and assessing the change of GLS score. Decrease of GLS score was higher in the intervention group compared to the control group, although the decrease was not statistically significant (0.767 ± 0.355 vs. 0.897 ± 0.526; p = 0.838). Percentage wise, similar findings were reported, albeit no significant (3.34 ± 1.65 vs. 3.46 vs. 2.58; p = 0.968).
Conclusions


Carvedilol was not able to prevent the decline of subclinical left ventricular function after such chemotherapy cycle. However, it maybe more likely that the benefits appear in patients whose given larger cumulative dose of anthracycline and have multiple risk factors.",2020,"Decrease of GLS score was higher in the intervention group compared to the control group, although the decrease was not statistically significant (0.767 ± 0.355 vs. 0.897 ± 0.526; p = 0.838).","['breast cancer patients', 'Result\n\n\nEighty patients were enrolled to the study, with each group consisted of 40 patients', 'breast cancer patients receiving FAC regimen chemotherapy']","['carvedilol', 'anthracycline', 'FAC chemotherapy', 'prophylactic carvedilol', 'breast cancer patients currently receiving post-first cycle FAC chemotherapy regimen', 'carvedilol with initial dose of 2\xa0×\xa06.25', 'Carvedilol']","['Left ventricular function', 'subclinical left ventricular function', 'GLS score', 'GLS score of left ventricle', 'subclinical left ventricular dysfunction']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517821', 'cui_str': '6.25'}]","[{'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}]",80.0,0.0303919,"Decrease of GLS score was higher in the intervention group compared to the control group, although the decrease was not statistically significant (0.767 ± 0.355 vs. 0.897 ± 0.526; p = 0.838).","[{'ForeName': 'Januar', 'Initials': 'J', 'LastName': 'Wibawa Martha', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Universitas Padjadjaran, Jalan Eyckman 38, Bandung 40161, Indonesia.'}, {'ForeName': 'Dery A', 'Initials': 'DA', 'LastName': 'Soedarsono', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Universitas Padjadjaran, Jalan Eyckman 38, Bandung 40161, Indonesia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Iqbal', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Universitas Padjadjaran, Jalan Eyckman 38, Bandung 40161, Indonesia.'}, {'ForeName': 'Astri', 'Initials': 'A', 'LastName': 'Astuti', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Universitas Padjadjaran, Jalan Eyckman 38, Bandung 40161, Indonesia.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Martanto', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Universitas Padjadjaran, Jalan Eyckman 38, Bandung 40161, Indonesia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rizki Akbar', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Universitas Padjadjaran, Jalan Eyckman 38, Bandung 40161, Indonesia.'}, {'ForeName': 'I Gede', 'Initials': 'IG', 'LastName': 'Sumantra', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Universitas Padjadjaran, Jalan Eyckman 38, Bandung 40161, Indonesia.'}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2020.100575']
2692,32671232,Integrating eye health training into the primary child healthcare programme in Tanzania: a pre-training and post-training study.,"Objectives


To evaluate a primary child eye care training module for use in the WHO/UNICEF Integrated Management of Newborn and Childhood Illness (IMNCI) programme by primary healthcare workers.
Design


Pre-training and post-training study.
Setting


Primary healthcare facilities in a semirural district, central Tanzania.
Participants


54 primary healthcare workers selected by the Ministry of Health were trained during routine IMNCI training. All these healthcare workers were assessed pre-intervention and post-intervention. A subgroup of 40 were also assessed 6 months after the completion of training.
Intervention


Training in an IMNCI eye module, developed for child primary healthcare workers with the Tanzania Ministry of Health and eye care experts.
Main outcome measures


Knowledge, skills and attitudes were assessed using multiple choice questions, case studies and a self-assessment of skills using a Likert scale before and immediately after training, and 6 months later. A total score was derived. At 6 months, attitudes were assessed in semistructured interviews.
Results


69% PHWs trained were nurses. The baseline (before training) score was 29.9 (95% CI 27.5 to 32.4) and increased by 11.2 points (95% CI 8.3 to 14) immediately after training, and by 12.4 points (95% CI 9.2 to 15.6) at 6 months post the training. Therefore, the post-training scores increased and there was no evident difference in scores from immediately after training to 6 months later. Self-assessed confidence in skills decreased from 9/18 (95% CI 9 to 10) to 6/18 (95% CI 6 to 7). At 6 months, the module was reported as easy to understand and use, with challenges including difficulties in examining children's eyes and poor referral systems.
Conclusions


The module increased knowledge of child eye health in primary healthcare workers, which was maintained, and was acceptable. The module has since been included into the national IMNCI health policy in Tanzania.",2020,Self-assessed confidence in skills decreased from 9/18 (95% CI 9 to 10) to 6/18 (95% CI 6 to 7).,"['WHO/UNICEF Integrated Management of Newborn and Childhood Illness (IMNCI) programme by primary healthcare workers', 'Setting\n\n\nPrimary healthcare facilities in a semirural district, central Tanzania', 'Participants\n\n\n54 primary healthcare workers selected by the Ministry of Health were trained during routine IMNCI training', 'child primary healthcare workers with the Tanzania Ministry of Health and eye care experts']",['primary child eye care training module'],"['Self-assessed confidence in skills', 'Knowledge, skills and attitudes were assessed using multiple choice questions, case studies and a self-assessment of skills using a Likert scale', 'knowledge of child eye health']","[{'cui': 'C0041682', 'cui_str': ""United Nations Children's Fund""}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0085973', 'cui_str': 'Case Studies'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",54.0,0.0796964,Self-assessed confidence in skills decreased from 9/18 (95% CI 9 to 10) to 6/18 (95% CI 6 to 7).,"[{'ForeName': 'Aeesha N J', 'Initials': 'ANJ', 'LastName': 'Malik', 'Affiliation': 'International Centre of Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Mlika', 'Initials': 'M', 'LastName': 'Mafwiri', 'Affiliation': 'Department of Ophthalmology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Gilbert', 'Affiliation': 'International Centre of Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Min J', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Schellenberg', 'Affiliation': 'International Centre of Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ paediatrics open,['10.1136/bmjpo-2019-000629']
2693,32671248,"Reflective parenting home visiting program: A longitudinal study on the effects upon depression, anxiety and parenting stress in first-time mothers.","Objective


Our study aimed to investigate the effects of a reflective parenting home visiting program in first time-mothers at risk for depression, anxiety, and parenting stress, from three to 12 months after their child's birth.
Study design


The sample was composed by 77 first-time mothers and their healthy babies (53% boys and 47% girls). Mothers filled out the Edinburgh Postnatal Depression Scale, the State-Trait Anxiety Inventory, and the Parenting Stress Index-SF at 3, 6 and 12 months of the child. Thirty-six mothers were assigned to the experimental group and received the reflective parenting home-visiting program, the other 36 constituted the control group.
Results


Analyses showed a significant higher reduction in the level of depression, anxiety and parenting stress among mothers belonging to the experimental group, compared to the control group.
Conclusion


Our findings confirm the benefits of reflective parenting home visiting programs and underline the need to constantly evaluate the levels of depression, anxiety and parenting stress throughout the perinatal period to target effective prevention programs to foster early mother-child attachment bond.",2020,"Results


Analyses showed a significant higher reduction in the level of depression, anxiety and parenting stress among mothers belonging to the experimental group, compared to the control group.
","['first-time mothers', ""first time-mothers at risk for depression, anxiety, and parenting stress, from three to 12 months after their child's birth"", 'Thirty-six mothers']","['reflective parenting home-visiting program', 'Reflective parenting home visiting program', 'reflective parenting home visiting program']","['depression, anxiety and parenting stress', 'level of depression, anxiety and parenting stress', 'Edinburgh Postnatal Depression Scale, the State-Trait Anxiety Inventory']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0581135', 'cui_str': 'Birth of child'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",36.0,0.0187594,"Results


Analyses showed a significant higher reduction in the level of depression, anxiety and parenting stress among mothers belonging to the experimental group, compared to the control group.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vismara', 'Affiliation': 'Department of Pedagogy, Psychology Philosophy, University of Cagliari, Via Is Mirrionis 1, 09123, Cagliari, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sechi', 'Affiliation': 'Department of Pedagogy, Psychology Philosophy, University of Cagliari, Via Is Mirrionis 1, 09123, Cagliari, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Lucarelli', 'Affiliation': 'Department of Pedagogy, Psychology Philosophy, University of Cagliari, Via Is Mirrionis 1, 09123, Cagliari, Italy.'}]",Heliyon,['10.1016/j.heliyon.2020.e04292']
2694,32665778,Health-Related Quality of Life and Sleep Quality after 12 Months of Treatment in Nonsevere Obstructive Sleep Apnea: A Randomized Clinical Trial with Continuous Positive Airway Pressure and Mandibular Advancement Splints.,"In this randomized controlled trial, patients with nonsevere obstructive sleep apnea (OSA) were treated with continuous positive airway pressure (CPAP) or a twin block mandibular advancement splint (MAS). The primary objective was to compare how CPAP and MAS treatments change the health-related quality of life (HRQoL) and self-reported sleep quality of patients after 12 months of treatment. In total, 104 patients were recruited: 55 were allocated to the CPAP treatment group and 49 to the MAS treatment group. We used the SF36 questionnaire to evaluate HRQoL and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. All patients were included in the intention-to-treat analyses. These analyses showed improvements in the SF36 physical component score (from 48.8 ± 7.6 at baseline to 50.5 ± 8.0 at follow-up,  p =0.03) in the CPAP treatment group and in the mental component score (from 44.9 ± 12.1 to 49.3 ± 9.2,  p =0.009) in the MAS treatment group. The PSQI global score improved in both the CPAP (from 7.7 ± 3.5 to 6.6 ± 2.9,  p =0.006) and the MAS (8.0 ± 3.1 to 6.1 ± 2.6,  p  < 0.001) treatment groups. No difference was found between the treatment groups in any of the SF36 scores or PSQI global score at the final follow-up ( p  > 0.05) in any analysis. The improvement in the SF36 vitality domain moderately correlated to the improvement in the PSQI global score in both groups (CPAP: | r |=0.47,  p  < 0.001; MAS: | r |=0.36,  p =0.01). In the MAS treatment group, we also found a weak correlation between improvements in the SF36 mental component score and PSQI global score (| r |=0.28,  p =0.05). In conclusion, CPAP and MAS treatments lead to similar improvements in the HRQoL and self-reported sleep quality in nonsevere OSA. Improvements in aspects of HRQoL seem to be moderately correlated to the self-reported sleep quality in both CPAP and MAS treatments.",2020,No difference was found between the treatment groups in any of the SF36 scores or PSQI global score at the final follow-up ( p  > 0.05) in any analysis.,"['patients with nonsevere obstructive sleep apnea (OSA', '104 patients were recruited: 55', 'Nonsevere Obstructive Sleep Apnea']","['MAS treatment', 'CPAP', 'Continuous Positive Airway Pressure and Mandibular Advancement Splints', 'CPAP and MAS', 'continuous positive airway pressure (CPAP) or a twin block mandibular advancement splint (MAS']","['PSQI global score', 'SF36 vitality', 'HRQoL and self-reported sleep quality', 'SF36 questionnaire to evaluate HRQoL and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality', 'SF36 physical component score', 'SF36 scores or PSQI global score', 'SF36 mental component score and PSQI global score', 'mental component score', 'sleep quality', 'health-related quality of life (HRQoL) and self-reported sleep quality', 'Health-Related Quality of Life and Sleep Quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C5200825', 'cui_str': 'Mandibular Advancement Splints'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",104.0,0.0549215,No difference was found between the treatment groups in any of the SF36 scores or PSQI global score at the final follow-up ( p  > 0.05) in any analysis.,"[{'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Torun K S', 'Initials': 'TKS', 'LastName': 'Ankjell', 'Affiliation': 'ENT Department, University Hospital in Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Yi-Qian', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': 'Center for Oral Health Services and Research, Mid-Norway (TkMidt), Trondheim, Norway.'}, {'ForeName': 'Tordis A', 'Initials': 'TA', 'LastName': 'Trovik', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Oddveig G', 'Initials': 'OG', 'LastName': 'Rikardsen', 'Affiliation': 'ENT Department, University Hospital in Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sjögren', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Moen', 'Affiliation': 'ENT Department, Section for Oral and Maxillofacial Surgery, Arendal Hospital, Arendal, Norway.'}, {'ForeName': 'Sølve', 'Initials': 'S', 'LastName': 'Hellem', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Vegard', 'Initials': 'V', 'LastName': 'Bugten', 'Affiliation': ""Department of Otorhinolaryngology, Head and Neck Surgery, St. Olav's University Hospital, Trondheim, Norway.""}]",International journal of otolaryngology,['10.1155/2020/2856460']
2695,32665955,Immunogenicity of Inactivated Varicella Zoster Vaccine in Autologous Hematopoietic Stem Cell Transplant Recipients and Patients With Solid or Hematologic Cancer.,"Background


In phase 3 trials, inactivated varicella zoster virus (VZV) vaccine (ZV IN ) was well tolerated and efficacious against herpes zoster (HZ) in autologous hematopoietic stem cell transplant (auto-HSCT) recipients and patients with solid tumor malignancies receiving chemotherapy (STMc) but did not reduce HZ incidence in patients with hematologic malignancies (HMs). Here, we describe ZV IN  immunogenicity from these studies.
Methods


Patients were randomized to ZV IN  or placebo (4 doses). Immunogenicity was assessed by glycoprotein enzyme-linked immunosorbent assay (gpELISA) and VZV interferon (IFN)-γ enzyme-linked immunospot (ELISPOT) assay in patients receiving all 4 doses without developing HZ at the time of blood sampling.
Results


Estimated geometric mean fold rise ratios (ZV IN /placebo) by gpELISA and IFN-y ELISPOT ~28 days post-dose 4 were 2.02 (95% confidence interval [CI], 1.53-2.67) and 5.41 (95% CI, 3.60-8.12) in auto-HSCT recipients; 1.88 (95% CI, 1.79-1.98) and 2.10 (95% CI, 1.69-2.62) in patients with STMc; and not assessed and 2.35 (95% CI, 1.81-3.05) in patients with HM.
Conclusions


ZV IN  immunogenicity was directionally consistent with clinical efficacy in auto-HSCT recipients and patients with STMc even though HZ protection and VZV immunity were not statistically correlated. Despite a lack of clinical efficacy in patients with HM, ZV IN  immunogenicity was observed in this population. Immunological results did not predict vaccine efficacy in these 3 populations.
Clinical trial registration


NCT01229267, NCT01254630.",2020,"y ELISPOT ~28 days post-dose 4 were 2.02 (95% confidence interval [CI], 1.53-2.67) and 5.41 (95% CI, 3.60-8.12) in auto-HSCT recipients; 1.88 (95% CI, 1.79-1.98) and 2.10 (95% CI, 1.69-2.62) in patients with STMc; and not assessed and 2.35 (95% CI, 1.81-3.05) in patients with HM","['autologous hematopoietic stem cell transplant (auto-HSCT) recipients and patients with solid tumor malignancies receiving', 'patients receiving all 4 doses without developing HZ at the time of blood sampling', 'patients with hematologic malignancies (HMs', 'Autologous Hematopoietic Stem Cell Transplant Recipients and Patients With Solid or Hematologic Cancer']","['inactivated varicella zoster virus (VZV) vaccine (ZV IN ', 'chemotherapy (STMc', 'Inactivated Varicella Zoster Vaccine', 'HM', 'ZV', 'ZV IN  or placebo']","['glycoprotein enzyme-linked immunosorbent assay (gpELISA) and VZV interferon (IFN)-γ enzyme-linked immunospot (ELISPOT) assay', 'vaccine efficacy', 'Immunogenicity', 'tolerated and efficacious against herpes zoster (HZ']","[{'cui': 'C2193200', 'cui_str': 'Autologous haematopoietic stem cell transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]","[{'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1319755', 'cui_str': 'Varicella-zoster vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}]",,0.376942,"y ELISPOT ~28 days post-dose 4 were 2.02 (95% confidence interval [CI], 1.53-2.67) and 5.41 (95% CI, 3.60-8.12) in auto-HSCT recipients; 1.88 (95% CI, 1.79-1.98) and 2.10 (95% CI, 1.69-2.62) in patients with STMc; and not assessed and 2.35 (95% CI, 1.81-3.05) in patients with HM","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Boeckh', 'Affiliation': 'Vaccine and Infectious Disease & Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Arvin', 'Affiliation': 'Microbiology & Immunology Departments, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Camacho', 'Affiliation': 'Medical Oncology, Oncology Consultants, Houston, Texas, USA.'}, {'ForeName': 'Drew J', 'Initials': 'DJ', 'LastName': 'Winston', 'Affiliation': 'Department of Medicine, University of California Los Angeles Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Morrison', 'Affiliation': 'Hematology Oncology Division, Hennepin County Medical Center, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hurtado', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Durrand Hall', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Shu-Chih', 'Initials': 'SC', 'LastName': 'Su', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Paula W', 'Initials': 'PW', 'LastName': 'Annunziato', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Popmihajlov', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Open forum infectious diseases,['10.1093/ofid/ofaa172']
2696,32665956,Utilizing Behavioral Science to Improve Antibiotic Prescribing in Rural Urgent Care Settings.,"Background


Antibiotic-inappropriate prescribing for acute respiratory tract infections (ARTI) is 45% among urgent care centers (UCCs) in the United States. Locally in our UCCs, antibiotic-inappropriate prescribing for ARTI is higher-over 70%.
Methods


We used a quasi-experimental design to implement 3 behavioral interventions targeting antibiotic-inappropriate/non-guideline-concordant prescribing for ARTI at 3 high-volume rural UCCs and analyzed prescribing rates pre- and post-intervention. The 3 interventions were (1) staff/patient education, (2) public commitment, and (3) peer comparison. For peer comparison, providers were sent feedback emails with their prescribing data during the intervention period and a blinded ranking email comparing them with their peers. Providers were categorized as ""low prescribers"" (ie,  ≤23% antibiotic-inappropriate prescriptions based off the US National Action Plan for Combating Antibiotic Resistant Bacteria 2020 goal) or ""high prescribers"" (ie,  ≥45%-the national average of antibiotic-inappropriate prescribing for ARTI). An interrupted time series (ITS) analysis compared prescribing for ARTI (the primary outcome) over a 16-month period before the intervention and during the 6-month intervention period, for a total of 22 months, across the 3 UCCs.
Results


Fewer antibiotic-inappropriate prescriptions were written during the intervention period (57.7%) compared with the pre-intervention period (72.6%) in the 3 UCCs, resulting in a 14.9% absolute decrease in percentage of antibiotic-inappropriate prescriptions. The ITS analysis revealed that the rate of antibiotic-inappropriate prescribing was statistically significantly different pre-intervention compared with the intervention period (95% confidence interval, -4.59 to -0.59;  P  = .014).
Conclusions


In this sample of rural UCCs, we reduced antibiotic-inappropriate prescribing for ARTI using 3 behavioral interventions.",2020,"The ITS analysis revealed that the rate of antibiotic-inappropriate prescribing was statistically significantly different pre-intervention compared with the intervention period (95% confidence interval, -4.59 to -0.59;  P  = .014).
",['Rural Urgent Care Settings'],['\n\n\nAntibiotic-inappropriate prescribing'],"['rate of antibiotic-inappropriate prescribing', 'percentage of antibiotic-inappropriate prescriptions']","[{'cui': 'C2362545', 'cui_str': 'Urgent Care'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2936304', 'cui_str': 'Inappropriate Prescriptions'}]",,0.0492291,"The ITS analysis revealed that the rate of antibiotic-inappropriate prescribing was statistically significantly different pre-intervention compared with the intervention period (95% confidence interval, -4.59 to -0.59;  P  = .014).
","[{'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Cummings', 'Affiliation': 'Department of Epidemiology Research & Evaluation, Eisenhower Health, Rancho Mirage, California, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Alajajian', 'Affiliation': 'Pharmacy Department, Eisenhower Health, Rancho Mirage, California, USA.'}, {'ForeName': 'Larissa S', 'Initials': 'LS', 'LastName': 'May', 'Affiliation': 'Emergency Department Antibiotic Stewardship, Department of Emergency Medicine, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Urgent Care, Eisenhower Health, Rancho Mirage, California, USA.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Greer', 'Affiliation': 'Department of Epidemiology Research & Evaluation, Eisenhower Health, Rancho Mirage, California, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Sontz', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Dezfuli', 'Affiliation': 'Infectious Disease Clinic & Infusion Center, Eisenhower Health, Rancho Mirage, California, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa174']
2697,32665999,Efficacy of adding mirabegron to alpha-adrenoreceptor blocker in patients with benign prostatic hyperplasia with persistent overactive bladder symptoms: A prospective study.,"Purpose


To compare the efficacies of mirabegron 50 mg addition after alpha-adrenoreceptor blocker in terms of reducing storage symptoms in patients with BPH.
Materials and Methods


Fifty-eight patients that had been taking alpha-adrenoreceptor blocker for more than 8 weeks, but had an OABSS of greater than 3 points, were initially enrolled. One group added any alpha-adrenoreceptor blocker with mirabegron 50 mg (n=39; the mirabegron group) and the other group received alpha-adrenoreceptor blocker only (n=19; the control group) for 8 weeks.
Results


In the control group, mean total IPSS decreased from 15.7 to 13.1 (p=0.298) and in mirabegron group, mean total IPSS decreased from 19.4 to 16.5 (p=0.024). Mean storage symptom scores reduced in the control and mirabegron groups from 8.5 to 7.9 (p=0.584) and from 9.1 to 7.6 (p=0.015), respectively, and mean QoL scores from 3.7 to 3.1 (p=0.052) and 3.6 to 3.2 (p=0.027), respectively. Mean overall OABSS in the control and mirabegron groups reduced from 8.4 to 7.2 (p=0.173) and from 8.8 to 7.3, respectively (p=0.005); mean OABSS Q3 from 3.6 to 2.9 (p=0.073) and from 3.5 to 2.7 (p=0.002), respectively; and mean OABSS Q4 from 2.4 to 2.0 (p=0.306) and from 2.7 to 2.0 (p=0.016), respectively. The change of mean Qmax and PVR was insignificant in 2 groups.
Conclusions


IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms. Mirabegron 50 mg addition is considered to patients with persistent storage symptoms after alpha-adrenoreceptor blocker.",2020,"Conclusions


IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms.","['Materials and Methods\n\n\nFifty-eight patients that had been taking alpha-adrenoreceptor blocker for more than 8 weeks, but had an OABSS of greater than 3 points, were initially enrolled', 'patients with persistent storage symptoms after alpha-adrenoreceptor blocker', 'patients with benign prostatic hyperplasia with persistent overactive bladder symptoms', 'patients with BPH', 'Mirabegron 50']","['mirabegron 50 mg addition after alpha-adrenoreceptor blocker', 'alpha-adrenoreceptor blocker', 'mirabegron to alpha-adrenoreceptor blocker', 'alpha-adrenoreceptor blocker with mirabegron 50 mg']","['mean total IPSS', 'storage symptoms', 'Mean storage symptom scores', 'IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4', 'Mean overall OABSS', 'mean OABSS Q3', 'mean QoL scores', 'mean Qmax and PVR', 'mean OABSS Q4']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}]",58.0,0.0307978,"Conclusions


IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms.","[{'ForeName': 'Se Yun', 'Initials': 'SY', 'LastName': 'Kwon', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Dong Jin', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Seo', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Kyung Seop', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}]",Investigative and clinical urology,['10.4111/icu.2020.61.4.419']
2698,32666008,Effects of Dietary Carbohydrate Content on Circulating Metabolic Fuel Availability in the Postprandial State.,"Context


According to the carbohydrate-insulin model of obesity, an elevated insulin-to-glucagon ratio in response to a high-carbohydrate diet directs metabolic fuels toward storage, resulting in lower circulating energy.
Objective


To determine differences in total circulating energy post-meal related to dietary carbohydrate.
Design


Ancillary study within the Framingham State Food Study.
Setting


University community.
Participants


29 adults (aged 20 to 65 years) with overweight or obesity (body mass index ≥25 kg/m 2 ).
Intervention


After achieving 10% to 14% weight loss on a run-in diet, participants were randomized to weight-loss-maintenance test diets varying in carbohydrate content (high-carbohydrate, 60% of total energy, n = 11; moderate-carbohydrate, 40%, n = 8; low-carbohydrate, 20%, n = 10) and controlled for protein (20%). During 24-hour metabolic ward admissions between 10 and 15 weeks on the test diets, metabolic fuels and hormones were measured.
Main Outcome Measure


Energy availability (EA) based on energy content of blood glucose, beta-hydroxybutyrate, and free fatty acids, in the late postprandial period (180 to 300 minutes). Insulin at 30 minutes into the test meal (Meal Insulin-30) was measured as an effect modifier.
Results


Insulin-to-glucagon ratio was 7-fold higher in participants on the high- vs low-carbohydrate diet (2.5 and 0.36, respectively). Late postprandial EA was 0.58 kcal/L lower on the high- vs low-carbohydrate diet ( P  < 0.0001), primarily related to suppression of free fatty acids. Early postprandial EA (30 to 180 minutes) declined fastest in the high-carbohydrate group, and Meal Insulin-30 modified this diet effect.
Conclusions


During weight-loss maintenance on a high-carbohydrate diet, late postprandial EA is reduced, consistent with the carbohydrate-insulin model.",2020,"Results


Insulin-to-glucagon ratio was 7-fold higher in participants on the high- vs low-carbohydrate diet (2.5 and 0.36, respectively).","['Setting\n\n\nUniversity community', 'Participants\n\n\n29 adults (aged 20 to 65 years) with overweight or obesity (body mass index ≥25 kg/m 2 ']",['Dietary Carbohydrate Content'],"['Late postprandial EA', 'Results\n\n\nInsulin-to-glucagon ratio', 'Circulating Metabolic Fuel Availability', 'Energy availability (EA) based on energy content of blood glucose, beta-hydroxybutyrate, and free fatty acids, in the late postprandial period']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0012170', 'cui_str': 'Carbohydrates, Dietary'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",29.0,0.0165793,"Results


Insulin-to-glucagon ratio was 7-fold higher in participants on the high- vs low-carbohydrate diet (2.5 and 0.36, respectively).","[{'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'Shimy', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Gloria L', 'Initials': 'GL', 'LastName': 'Klein', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bielak', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, Massachusetts.""}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa062']
2699,32666034,Forecasting Your Future: Nutrition Matters  Curriculum with Teacher Training Promotes Students to Try New Fruits and Vegetables.,"Background


Many high school students do not consume the recommended amounts of fruits and vegetables.
Objective


This study evaluated student outcomes from a new nutrition curriculum that includes messages from the 2015-2020 Dietary Guidelines for Americans with a teacher training component for high school Family and Consumer Sciences (FACS) teachers.
Methods


A cluster-randomized controlled study was conducted with 1104 students in FACS classes from 35 schools, taught by teachers trained in implementing a new curriculum (intervention) and teachers using their usual curricula (control). Students completed online surveys at the beginning and end of the semester, that is, pre- and postexposure to the nutrition curricula. Intention-to-treat analyses as hierarchical linear modeling were performed to determine if the intervention students had significant changes compared with the control students for knowledge of nutrition concepts, familiarity of, preferences for, affinity toward, number of times trying new, and daily times eating fruits and vegetables. Per-protocol analyses used the same hierarchical linear model but instead of control and intervention groups, students were split into 3 levels describing the amount of the new curriculum they received (0%, 1-50%, and 51-100%).
Results


Students exposed to 51-100% of the new curriculum tried more fruits and vegetables than both the control students and the students that received 1-50% of the curriculum ( P  = 0.009 for fruits and  P  = 0.002 for vegetables). Additionally, there were higher increases in the number of times intervention students tried a new fruit ( P  = 0.027) and vegetable ( P  = 0.022) compared with the control students, regardless of the amount of curriculum received.
Conclusions


Our findings show that the curriculum,  Forecasting Your Future: Nutrition Matters , has promise for increasing exposure to new fruits and vegetables for students. If teachers use most of the curriculum, students are likely to try more new fruit and vegetables, which could ultimately contribute to improved health.",2020,"Additionally, there were higher increases in the number of times intervention students tried a new fruit ( P  = 0.027) and vegetable ( P  = 0.022) compared with the control students, regardless of the amount of curriculum received.
","['1104 students in FACS classes from 35 schools, taught by teachers trained in implementing a new curriculum (intervention) and teachers using their usual curricula (control', 'student outcomes from a new nutrition curriculum that includes messages from the 2015-2020 Dietary Guidelines for Americans with a teacher training component for high school Family and Consumer Sciences (FACS) teachers']",[],"['number of times intervention students tried a new fruit', 'fruits and vegetables']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0871930', 'cui_str': 'Teacher Education'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],"[{'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",,0.0157381,"Additionally, there were higher increases in the number of times intervention students tried a new fruit ( P  = 0.027) and vegetable ( P  = 0.022) compared with the control students, regardless of the amount of curriculum received.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kaschalk-Woods', 'Affiliation': 'School of Public Health, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Alyce D', 'Initials': 'AD', 'LastName': 'Fly', 'Affiliation': 'School of Public Health, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Foland', 'Affiliation': 'Indiana Department of Education - Office of School and Community Nutrition, Indianapolis, IN, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'School of Public Health, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Xiwei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Indiana University, Bloomington, IN, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa101']
2700,32666238,Effect of T-Piece Resuscitator versus Self Inflating Bag on Arterial CO 2  Levels in Preterm Neonates.,"OBJECTIVE


To compare the effect of self-inflating bag (SIB) vs. T-piece resuscitator (TPR) on PaCO 2  levels, when used for brief manual ventilation during administration of first dose of surfactant.
METHODS


Preterm neonates were randomized to receive positive pressure ventilation with either self-inflating bag or T-piece resuscitator during administration of first dose of surfactant. Arterial blood gases were obtained at baseline and 1 h after the intervention. Primary outcome was the mean change in PaCO 2  levels 1 h after the intervention.
RESULTS


Eighty neonates were enrolled (40 in each group). The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01]. The PaCO 2  change was also statistically significant in the subgroup of infants that required only non-invasive ventilation. The need for second dose of surfactant was higher in the self-inflating bag group [77% vs. 55%, RR - 1.41 (95% CI: 1.02 to 1.94); P = 0.03].
CONCLUSIONS


T-piece resuscitator results in smaller reduction in PaCO 2  levels compared to the self inflating bag, when used for brief manual ventilation during surfactant administration.",2020,"The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01].","['Preterm neonates', 'Preterm Neonates', 'Eighty neonates were enrolled (40 in each group']","['positive pressure ventilation with either self-inflating bag or T-piece resuscitator during administration of first dose of surfactant', 'self-inflating bag (SIB) vs. T-piece resuscitator (TPR', 'T-Piece Resuscitator versus Self']","['Arterial blood gases', 'mean change in PaCO 2  levels']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0182998', 'cui_str': 'Resuscitator'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}]",80.0,0.188474,"The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01].","[{'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Jeevan', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India.""}, {'ForeName': 'Haribalakrishna', 'Initials': 'H', 'LastName': 'Balasubramanian', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India. doctorhbk@gmail.com.""}, {'ForeName': 'Nandkishor', 'Initials': 'N', 'LastName': 'Kabra', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India.""}]",Indian journal of pediatrics,['10.1007/s12098-020-03393-x']
2701,32666240,Locking compression plate fixation versus intramedullary nailing of humeral shaft fractures: which one is better? A single-centre prospective randomized study.,"PURPOSE


To compare the radiological and clinical outcomes of interlocking nail (ILN) and locking plate fixation (LCP) for humeral shaft fractures.
METHODS


A total of 63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively. They were divided randomly into two as LCP fixation (group 1) and interlocking nail (ILN) (group 2). Functional outcomes were evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS).
RESULTS


After fracture callus was radiologically observed, DASH, ASES, and UCLA scores as well as SF-36 questionnaires and VAS results were noted to have no significant difference between the two groups (p = 0.109, p = 0.082, p = 0.146, p = 0.322, and p = 0.175, respectively). At the last follow-up (post-operative 24 months), the UCLA score was significantly better in group 1 (p = 0.034), whereas VAS result was significantly worse in group 2 (p = 0.017). DASH, ASES scores, and SF-36 questionnaires had no difference (p = 0.193, p = 0.088, p = 0.289). Other parameters revealed no significant differences. Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189). Four patients in group 1 and five patients in group 2 underwent surgery for nonunion (p = 0.725). Post-operative radial nerve palsy was seen in one patient in group 2. Two patients in group 1 with superficial infection were treated with antibiotics, and they recovered.
CONCLUSIONS


Regarding our results, the LCP group had significantly better shoulder function than the ILN group, whereas the ILN group had significantly less pain, with similar complication rates. Therefore, both procedures are favourable surgical options for patients with humeral shaft fractures.",2020,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"['humeral shaft fractures', 'patients with humeral shaft fractures', '63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively']","['LCP fixation', 'LCP', 'interlocking nail (ILN) and locking plate fixation (LCP', 'interlocking nail (ILN', 'Locking compression plate fixation versus intramedullary nailing']","['VAS result', 'UCLA score', 'shoulder function', 'Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS', 'DASH, ASES scores, and SF-36 questionnaires', 'DASH, ASES, and UCLA scores', 'Fracture consolidation', 'pain', 'SF-36 questionnaires and VAS results']","[{'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}]",63.0,0.0209717,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Akalın', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey. dryakalin@yahoo.com.'}, {'ForeName': 'İsmail Gökhan', 'Initials': 'İG', 'LastName': 'Şahin', 'Affiliation': 'Turkish Ministry of Health, Edirne Sultan 1. Murat Devlet Hastanesi, Department of Orthopaedics and Traumatology, 22100, Edirne, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Çevik', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Burak Olcay', 'Initials': 'BO', 'LastName': 'Güler', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Avci', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Alpaslan', 'Initials': 'A', 'LastName': 'Öztürk', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04696-6']
2702,32666256,Outcome of a novel modified endoscopic papillectomy for duodenal major papilla adenoma.,"BACKGROUND AND AIMS


In recent years, with the development of endoscopic techniques, endoscopic resection is widely used for duodenal papillary adenomas, but conventional endoscopic resection has a high rate of incomplete resection and recurrence. On this basis, we have employed a novel modified endoscopic papillectomy (ESP). In this study, we evaluated the feasibility and advantages of this ESP for the treatment of duodenal major papilla adenoma.
METHODS


A total of 56 patients with duodenal major papilla adenoma confirmed by endoscopic ultrasonography, intraluminal ultrasound and gastroscopic biopsy from October 2007 to June 2017 were collected in the Department of Gastroenterology, Nanjing Drum Tower Hospital. The diameter of the adenoma ranged from 1.41 to 2.02 cm. 16 cases were given the conventional method and 40 cases underwent the modified ESP procedure in which a small incision was made by cutting current when anchoring the snare tip on the distal side of the adenoma.
RESULTS


En bloc resection rate was significantly higher in the modified group (100%, 40/40) than that in the conventional group (81.3%, 13/16; P = 0.02). However, no significance was seen between the modified group and the conventional group in complete resection rate (92.5%, 37/40 vs 93.8%, 15/16; P = 1.00). There was no significant difference in the number and difficulty of postoperative pancreatic and biliary stents placement between the two groups (P = 0.20). Total bleeding occurrence was much lower in the modified group (37.5%, 15/40 vs 87.5%, 14/16; P = 0.001), and no significant differences were found in other short-term complications and the 3, 6, 12 and 24 months recurrences rate between the conventional and modified ESP groups.
CONCLUSIONS


The modified ESP improves the treatment outcome of duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate.",2020,The modified ESP improves the treatment outcome of duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate.,"['duodenal major papilla adenoma', '56 patients with duodenal major papilla adenoma confirmed by endoscopic ultrasonography, intraluminal ultrasound and gastroscopic biopsy from October 2007 to June 2017 were collected in the Department of Gastroenterology, Nanjing Drum Tower Hospital']","['endoscopic papillectomy (ESP', 'novel modified endoscopic papillectomy', 'modified ESP procedure', 'ESP']","['duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate', 'recurrences rate', 'En bloc resection rate', 'number and difficulty of postoperative pancreatic and biliary stents placement', 'Total bleeding occurrence', 'complete resection rate']","[{'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",56.0,0.0169184,The modified ESP improves the treatment outcome of duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate.,"[{'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Chengfei', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Xiwei', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China. 867152094@qq.com.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China. 13770771661@163.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07715-0']
2703,32666281,Effect of tactile/kinesthetic massage therapy on growth and body composition of preterm infants.,"Massage therapy (MT) improves growth parameters in preterm infants. The growth of lean mass rather than fat mass has been associated with better long-term outcomes. We aimed to study the effect of tactile/kinesthetic MT on growth and body composition parameters in preterm infants. Preterm (< 32 weeks gestation) infants were randomly assigned at corrected gestational age of 35 weeks to receive 3 consecutive, 15-min, sessions of MT over 5 days or routine care. Primary outcome was mean daily weight gain. Secondary outcomes included anthropometric measurements and body composition parameters assessed by dual X-ray absorptiometry (DXA) scan. Out of 218 infants screened, 86 were eligible and 60 infants (30 in each group) were recruited after parental consent. MT was associated with significant increase in daily weight gain [19.3 (10-34.3) versus 6.2 (2.5-18.4) g/day, p = 0.01] and growth velocity [12.5 (6-21) versus 3.6 (1.6-12.6) g/kg/d, p = 0.01] compared with routine care. Infants on MT showed significant increase in total body mass, fat mass (total/legs), lean mass (total/arms/legs/trunk), and bone mineral density (arms/legs/trunk) values compared with routine care group. In conclusions, MT improves growth quality as evident by increased total and regional lean masses, increased bone mineral density, and peripheral rather than central fat distribution. What is known on this subject? • Massage therapy (MT) for preterm infants leads to achievement of faster independent oral feeding, increased weight gain, less stress, less response to pain, less occurrence of sepsis, and shorter hospital stay. • Growth of lean mass rather than fat mass has been associated with better long-term outcomes. What this study adds? • Tactile/kinesthetic massage therapy in preterm infant is associated with improved growth parameters and anthropometric measures. • Tactile/kinesthetic massage therapy increased total body mass, fat mass (total/legs), lean mass (total/arms/legs/trunk), and bone mineral density (arms/legs/trunk) values.",2020,"Tactile/kinesthetic massage therapy increased total body mass, fat mass (total/legs), lean mass (total/arms/legs/trunk), and bone mineral density (arms/legs/trunk) values.","['Preterm (<\u200932\xa0weeks gestation) infants', 'preterm infants', '218 infants screened, 86 were eligible and 60 infants (30 in each group) were recruited after parental consent']","['Massage therapy (MT', 'Tactile/kinesthetic massage therapy', 'tactile/kinesthetic massage therapy', 'tactile/kinesthetic MT']","['growth and body composition parameters', 'total body mass, fat mass (total/legs), lean mass (total/arms/legs/trunk), and bone mineral density', 'growth quality', 'mean daily weight gain', 'anthropometric measurements and body composition parameters assessed by dual X-ray absorptiometry (DXA) scan', 'weight gain, less stress, less response to pain, less occurrence of sepsis, and shorter hospital stay', 'growth and body composition', 'growth velocity', 'growth parameters', 'total and regional lean masses, increased bone mineral density, and peripheral rather than central fat distribution', 'daily weight gain', 'total body mass, fat mass (total/legs), lean mass (total/arms/legs/trunk), and bone mineral density (arms/legs/trunk) values']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}]","[{'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0029464', 'cui_str': 'Osteosclerosis'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",86.0,0.122719,"Tactile/kinesthetic massage therapy increased total body mass, fat mass (total/legs), lean mass (total/arms/legs/trunk), and bone mineral density (arms/legs/trunk) values.","[{'ForeName': 'Maha Abd', 'Initials': 'MA', 'LastName': 'Elmoneim', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Heba Azmy', 'Initials': 'HA', 'LastName': 'Mohamed', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Awad', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'El-Hawary', 'Affiliation': ""Paediatric Endocrinology Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Nanees', 'Initials': 'N', 'LastName': 'Salem', 'Affiliation': ""Paediatric Endocrinology Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'El Helaly', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nehad', 'Initials': 'N', 'LastName': 'Nasef', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Egypt. nehad_nasef@mans.edu.eg.""}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Abdel-Hady', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}]",European journal of pediatrics,['10.1007/s00431-020-03738-w']
2704,32666291,Comparison of middle ear function and hearing thresholds in children with adenoid hypertrophy after microdebrider and conventional adenoidectomy: a randomised controlled trial.,"BACKGROUND


Microdebrider has superior efficacy in clearing the adenoids, compared to curettage. We compared the improvement in middle ear function and hearing thresholds after adenoidectomy, by both methods.
MATERIALS AND METHODS


126 patients (median age-9 years) were randomized into groups A and B, where adenoidectomy was done by microdebrider and curettage, respectively. Middle ear function parameters and hearing thresholds were measured serially.
RESULTS


The mean improvement in middle ear pressure, compliance and hearing thresholds were 92.5 ± 67.6 and 84.2 ± 71.4 daPa; (p = 0.40), 0.19 ± 0.34 and 0.27 ± 0.27 mL; (p = 0.07) and 3.20 ± 4.95 and 2.54 ± 3.98 dB; (p = 0.27), in groups A and B, respectively. Reversal of type B tympanograms was noted in both groups.
CONCLUSIONS


Middle ear function and hearing thresholds improved in both groups after adenoidectomy. More improvement was noted in the microdebrider group, which, however, was not significant.",2020,Middle ear function and hearing thresholds improved in both groups after adenoidectomy.,"['children with adenoid hypertrophy after microdebrider and', '126 patients (median age-9\xa0years']",['conventional adenoidectomy'],"['Middle ear function parameters and hearing thresholds', 'middle ear function and hearing thresholds', 'mean improvement in middle ear pressure, compliance and hearing thresholds', 'Middle ear function and hearing thresholds']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}]","[{'cui': 'C0457585', 'cui_str': 'Middle ear function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0457587', 'cui_str': 'Middle ear pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",126.0,0.110676,Middle ear function and hearing thresholds improved in both groups after adenoidectomy.,"[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Rajan', 'Affiliation': 'Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur, 342005, India. rajannikhil3@gmail.com.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Saxena', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Pradipta Kumar', 'Initials': 'PK', 'LastName': 'Parida', 'Affiliation': 'Department of Otorhinolaryngology, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Alexander', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Sivaraman', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06197-z']
2705,32666313,Effects of a multi-modal resistance exercise program and calcium-vitamin D 3  fortified milk on blood pressure and blood lipids in middle-aged and older men: secondary analysis of an 18-month factorial design randomised controlled trial.,"PURPOSE


Physical activity and dietary interventions are recommended as front-line therapy for prevention and management of cardiovascular disease. This study investigated the independent and combined effects of low-fat, calcium-vitamin D 3  fortified milk and multi-modal exercise training on blood pressure (BP) and blood lipids in middle-aged and older men.
METHODS


This was a pre-planned secondary analysis of an 18-month, randomised controlled trial. Community-dwelling men aged 50-79 years (n = 180) were randomised into (i) exercise + fortified milk; (ii) fortified milk; (iii) exercise; or (iv) control. The low-fat milk (400 mL/day) was fortified with 1,000 mg/day calcium and 800 IU/day of vitamin-D 3 , whilst the exercise intervention consisted of three sessions/week of resistance- and weight-bearing impact exercises. Resting BP and fasting lipids were assessed at baseline, 6 (lipids only), 12 and 18 months.
RESULTS


Mean ± SD serum 25(OH)D and calcium intake for the entire cohort at baseline was 86 ± 36 nmol/L and 1002 ± 397 mg/day, respectively, with 10% classified as vitamin-D insufficient and 58% reporting a calcium intake below 1000 mg/day. There were no exercise-by-fortified milk interactions, nor any main-group effects for exercise or milk on BP or lipids at any time. However, there were significant reductions from baseline to 18 months in systolic (mean change, 5-8 mmHg) and diastolic (4-6 mmHg) BP in the exercise, fortified milk and control groups. All results remained largely unchanged after adjusting for use of anti-hypertensive or lipid lowering medication, weight or fat mass, or only including men with hypertension (n = 89) or dyslipidemia (n = 130) at baseline.
CONCLUSION


Supplementation with low-fat, calcium + vitamin D 3  fortified milk and a multi-modal exercise program, alone or in combination, was not effective for improving BP or blood lipids in community-dwelling middle-aged and older men.",2020,"fortified milk and a multi-modal exercise program, alone or in combination, was not effective for improving BP or blood lipids in community-dwelling middle-aged and older men.","['Community-dwelling men aged 50-79\xa0years (n\u2009=\u2009180', 'community-dwelling middle-aged and older men', 'men with hypertension (n\u2009=\u200989) or dyslipidemia (n\u2009=\u2009130) at baseline', 'middle-aged and older men']","['fortified milk and a multi-modal exercise program, alone or in combination', 'resistance- and weight-bearing impact exercises', 'exercise\u2009+\u2009fortified milk; (ii) fortified milk; (iii) exercise; or (iv) control', 'multi-modal resistance exercise program and calcium-vitamin D 3  fortified milk', 'low-fat, calcium-vitamin D 3  fortified milk and multi-modal exercise training', 'Supplementation with low-fat, calcium\u2009+\u2009vitamin D 3']","['Mean\u2009±\u2009SD serum 25(OH)D and calcium intake', 'Resting BP and fasting lipids', 'blood pressure and blood lipids', 'BP or blood lipids', 'blood pressure (BP) and blood lipids', 'BP or lipids']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",,0.12253,"fortified milk and a multi-modal exercise program, alone or in combination, was not effective for improving BP or blood lipids in community-dwelling middle-aged and older men.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Foulkes', 'Affiliation': 'Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, 3125, Australia.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Kukuljan', 'Affiliation': 'Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, 3125, Australia.'}, {'ForeName': 'Caryl A', 'Initials': 'CA', 'LastName': 'Nowson', 'Affiliation': 'Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, 3125, Australia.'}, {'ForeName': 'Kerrie M', 'Initials': 'KM', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, 3125, Australia. rmdaly@deakin.edu.au.'}]",European journal of nutrition,['10.1007/s00394-020-02325-x']
2706,32666333,Six and eight weeks injection frequencies of bevacizumab are non-inferior to the current four weeks injection frequency for quality of life in neovascular age-related macular degeneration: a randomized controlled trial.,"PURPOSE


Patients with neovascular age-related macular degeneration (nARMD) will not deteriorate on visual acuity and retinal thickness when treated with bevacizumab injection frequencies of 6 or 8 weeks compared to 4 weeks. This study aimed to investigate this non-inferiority in quality of life (QoL). We hypothesized that less frequent bevacizumab injections are not inferior regarding patients reported QoL.
METHODS


Patients were randomized to bevacizumab every 4 (n = 64), 6 (n = 63), and 8 weeks (n = 64). Patients were at least 65 years old, have a best-corrected visual acuity of 20/200 to 20/20, no previous ARMD treatment and active leakage. Vision-related QoL questionnaire NEI VFQ-39 was used to assess QoL at baseline and after 1 year. General QoL questionnaire SF-36 was included for secondary analysis. Multilevel analyses were performed, correcting for age, gender and baseline.
RESULTS


The 6 (3.68; 95% CI - 0.63 to 8.00) and 8 (2.15; 95% CI - 2.26 to 6.56) weeks bevacizumab regimens resulted in non-inferior QoL differences compared to 4 weeks on the NEI VFQ-39. Also on the SF-36 the differences were well within the non-inferiority limits.
CONCLUSION


Non-inferiority of the 6 and 8 weeks frequencies was demonstrated compared to 4 weeks on vision-related and general QoL in patients with nARMD. These results are in line with previously published results of lower frequency injections regarding visual acuity and central retinal thickness. Lower injection frequency may reduce burden, side effects, and treatment costs. In consideration of these results, 8 weeks frequency injections of intravitreal bevacizumab could be considered in patients with nARMD.",2020,"Also on the SF-36 the differences were well within the non-inferiority limits.
","['Patients with neovascular age-related macular degeneration (nARMD', 'neovascular age-related macular degeneration', 'Patients were at least 65\xa0years old, have a best-corrected visual acuity of 20/200 to 20/20, no previous ARMD treatment and active leakage', 'patients with nARMD']","['bevacizumab injections', 'intravitreal bevacizumab', 'bevacizumab']","['quality of life', 'quality of life (QoL', 'General QoL questionnaire SF-36', 'visual acuity and central retinal thickness', 'Vision-related QoL questionnaire NEI VFQ-39']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0442750', 'cui_str': 'Distance vision 6/6'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]","[{'cui': 'C4019040', 'cui_str': 'bevacizumab Injection'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}]",,0.33089,"Also on the SF-36 the differences were well within the non-inferiority limits.
","[{'ForeName': 'Martijn S', 'Initials': 'MS', 'LastName': 'Visser', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. m.s.visser@erasmusmc.nl.'}, {'ForeName': 'Sankha', 'Initials': 'S', 'LastName': 'Amarakoon', 'Affiliation': 'Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Missotten', 'Affiliation': 'Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan J V', 'Initials': 'JJV', 'LastName': 'Busschbach', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02580-9']
2707,32666349,Probiotic strains of Lactobacillus brevis and Lactobacillus plantarum as adjunct to non-surgical periodontal therapy: 3-month results of a randomized controlled clinical trial.,"OBJECTIVES


To determine if periodontitis patients benefit from treatment with Lactobacillus brevis and Lactobacillus plantarum strains, applied into periodontal pockets as gel and thereafter taken as lozenges, as an adjunct to scaling and root planing (SRP).
MATERIALS AND METHODS


In a double-blind, randomized, placebo-controlled trial, 40 patients received scaling and root planing (SRP) in two sessions within 7 days. Patients then received either probiotic gel and lozenges (n = 20) or placebo (n = 20). The primary outcome variable was the number of diseased sites (DS: PD > 4 mm + BOP) at the 3-month re-evaluation. The effects of gender, age, probiotic therapy, presence of Porphyromonas gingivalis or Aggregatibacter actinomycetemcomitans, smoking, tooth being a molar and interdental location were evaluated using a multivariate multilevel logistic regression model.
RESULTS


The number of DS after 3 months was similar in the test (Me = 8, IQR = 5-11) and control (Me = 5, IQR = 1-10) groups. Both groups showed substantial but equivalent improvements in periodontal parameters. The logistic regression showed higher odds for the healing of gingival bleeding (OR = 2.12, p = 0.048) and lower odds for the healing of DS (OR = 0.51; p < 0.001) in the probiotic group.
CONCLUSIONS


Patients with periodontitis benefit from adjunctive use of probiotics containing L. brevis and L. plantarum in terms of reduction of gingival bleeding. However, adjunctive probiotics increase the number of persisting diseased sites with PD > 4 mm and BOP.
CLINICAL RELEVANCE


The adjunctive use of probiotics containing L. brevis and L. plantarum strains in treating chronic periodontitis results in a higher number of residual diseased sites when compared with SRP + placebo; its use is therefore unfounded.",2020,"The number of DS after 3 months was similar in the test (Me = 8, IQR = 5-11) and control (Me = 5, IQR = 1-10) groups.","['40 patients received', 'periodontitis patients']","['Lactobacillus brevis and Lactobacillus plantarum', 'SRP + placebo', 'Lactobacillus brevis and Lactobacillus plantarum strains', 'probiotics containing L. brevis and L. plantarum strains', 'probiotic gel and lozenges', 'scaling and root planing (SRP', 'placebo']","['healing of gingival bleeding', 'number of DS', 'periodontal parameters', 'healing of DS', 'Porphyromonas gingivalis or Aggregatibacter actinomycetemcomitans, smoking, tooth being a molar and interdental location', 'number of diseased sites (DS: PD\u2009>\u20094\xa0mm\u2009+\u2009BOP', 'gingival bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0317604', 'cui_str': 'Lactobacillus brevis'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085488', 'cui_str': 'Aggregatibacter actinomycetemcomitans'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}]",40.0,0.0876832,"The number of DS after 3 months was similar in the test (Me = 8, IQR = 5-11) and control (Me = 5, IQR = 1-10) groups.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pudgar', 'Affiliation': 'Public Health Centre, 2360, Radlje ob Dravi, Slovenia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Povšič', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Čuk', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seme', 'Affiliation': 'Faculty of Medicine, Institute of Microbiology and Immunology, University of Ljubljana, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Petelin', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gašperšič', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia. rok.gaspersic@mf.uni-lj.si.'}]",Clinical oral investigations,['10.1007/s00784-020-03449-4']
2708,32663043,Upper Airway Stimulation versus Untreated Comparators in Positive Airway Pressure Treatment Refractory Obstructive Sleep Apnea.,"RATIONALE


Understand the impact of insurance coverage on sleep apnea outcomes for patients awaiting upper airway stimulation.
OBJECTIVES


Examine the natural history of impact of Upper Airway Stimulation treatment versus insurance denial (comparators) on sleep apnea outcomes.
METHODS


A parallel arm experimental study design was used to compare objective sleep apnea measures and patient reported outcomes in those who received Upper Airway Stimulation approval versus denial in a multi-national prospective study (NCT02907398). Wilcoxon rank sum test and logistic regression models were used to assess for differences of objective and subjective outcome changes in those who underwent Upper Airway Stimulation versus no treatment comparators.
MEASUREMENTS AND MAIN RESULTS


A greater reduction in apnea-hypopnea index was observed in those who underwent Upper Airway Stimulation versus no treatment (-19.1 ± 15.8 vs -8.1 ± 20.9 respectively, p < 0.001) with consistent findings observed with nocturnal hypoxia measures. Concordantly, a greater improvement noted with subjective measures of dozing propensity was observed in patients undergoing Upper Airway Stimulation versus comparators (Epworth Score, -5.1 ± 5.5 vs 1.8 ± 3.7 respectively, p < 0.001) and overall sleep-related patient reported outcomes. Women and those with previous oral appliance use had a lower odds of insurance approval (OR=0.40, 95% CI: 0.22 - 0.71 and OR=0.35, 95% CI: 0.18 - 0.69) respectively.
CONCLUSIONS


Results underscore the need to optimize clinical care pathways focused on effective treatment of obstructive sleep apnea patients not Upper Airway Stimulation-insurance eligible and prioritize public health policy initiatives to address insurance-based sex-specific disparities.",2020,"A greater reduction in apnea-hypopnea index was observed in those who underwent Upper Airway Stimulation versus no treatment (-19.1 ± 15.8 vs -8.1 ± 20.9 respectively, p < 0.001) with consistent findings observed with nocturnal hypoxia measures.","['Treatment Refractory Obstructive Sleep Apnea', 'obstructive sleep apnea patients', 'patients awaiting upper airway stimulation']","['Upper Airway Stimulation approval versus denial', 'Upper Airway Stimulation versus Untreated Comparators in Positive Airway Pressure', 'Upper Airway Stimulation treatment versus insurance denial (comparators']","['overall sleep', 'objective sleep apnea measures', 'sleep apnea outcomes', 'subjective measures of dozing propensity', 'apnea-hypopnea index']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0011317', 'cui_str': 'Denial - mental defense mechanism'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0180547,"A greater reduction in apnea-hypopnea index was observed in those who underwent Upper Airway Stimulation versus no treatment (-19.1 ± 15.8 vs -8.1 ± 20.9 respectively, p < 0.001) with consistent findings observed with nocturnal hypoxia measures.","[{'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Case Western Reserve University, Sleep Center, Neurologic Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States; MEHRAR@ccf.org.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Steffen', 'Affiliation': 'University of Lubeck, Luebeck, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Heiser', 'Affiliation': 'Technische Universitaet Muenchen, Department of Otorhinolaryngology, Munich, Bayern, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Hofauer', 'Affiliation': 'University Medical Center Freiburg, 14879, Freiburg, Baden-Württemberg, Germany.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Withrow', 'Affiliation': 'University of Alabama School of Medicine Huntsville, 69981, Huntsville, Alabama, United States.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Doghramji', 'Affiliation': 'Thomas Jefferson University, 6559, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'Boon', 'Affiliation': 'Thomas Jefferson University, 6559, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Huntley', 'Affiliation': 'Thomas Jefferson University, 6559, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Soose', 'Affiliation': 'University of Pittsburgh, Otolaryngology, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'University of Kansas Medical Center, 21638, Kansas City, Kansas, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Larsen', 'Affiliation': 'Kansas University Medical Center, Andover, Kansas, United States.'}, {'ForeName': 'Joachim T', 'Initials': 'JT', 'LastName': 'Maurer', 'Affiliation': 'University-Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Waters', 'Affiliation': 'Cleveland Clinic, 2569, Cleveland, Ohio, United States.'}, {'ForeName': 'Harneet K', 'Initials': 'HK', 'LastName': 'Walia', 'Affiliation': 'Cleveland Clinic, Sleep Disorders Center, Neurological Institute, Cleveland, Ohio, United States.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Kominsky', 'Affiliation': 'Cleveland Clinic, 2569, Cleveland, Ohio, United States.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Trask', 'Affiliation': 'Cleveland Clinic Foundation, Otolaryngology & Sleep Medicine, Cleveland, Ohio, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Schwab', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Thaler', 'Affiliation': 'University of Pennsylvania, Center for Sleep and Circadian Neurobiology, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Strollo', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202001-015OC']
2709,32663055,Exploring the Impact of Mindfulness on False-Memory Susceptibility.,"Wilson, Mickes, Stolarz-Fantino, Evrard, and Fantino (2015) presented data from three well-powered experiments suggesting that a brief mindfulness induction can increase false-memory susceptibility. However, we had concerns about some of the methodology, including whether mind wandering is the best control condition for brief mindfulness inductions. Here, we report the findings from a preregistered double-blind randomized controlled trial designed to replicate and extend Wilson et al.'s findings. Participants ( N  = 287) underwent 15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures. This was followed by free-recall and recognition tasks. There was no evidence for an effect of state of mind on correct or false recall or recognition. Furthermore, manipulation checks revealed that mindfulness and mind-wandering inductions activated overlapping states of mind. Exploratory analyses provided some support for mindfulness increasing false memory, but it appears that mind wandering may not be the right control for brief mindfulness research.",2020,There was no evidence for an effect of state of mind on correct or false recall or recognition.,['Participants ( N  = 287) underwent'],['15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures'],"['false-memory susceptibility', 'False-Memory Susceptibility']","[{'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0233569', 'cui_str': 'Wandering'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]","[{'cui': 'C0561845', 'cui_str': 'False memories'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",,0.0455014,There was no evidence for an effect of state of mind on correct or false recall or recognition.,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sherman', 'Affiliation': 'School of Psychology, Keele University.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Grange', 'Affiliation': 'School of Psychology, Keele University.'}]",Psychological science,['10.1177/0956797620929302']
2710,32663066,Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial - description of device use and physiotherapy support in the post-hospital phase.,"PURPOSE


To describe device use and physiotherapy support in the post-hospital phase of the AMOUNT rehabilitation trial.
METHODS


We performed an evaluation of the support required for device use by participants randomised to the intervention group who received digitally-enabled rehabilitation in the post-hospital phase ( n  = 144). Intervention, additional to standard rehabilitation, utilised eight digital devices (virtual reality videogames, activity monitors and handheld computer devices) to improve mobility and increase physical activity. Participants were taught to use devices during inpatient rehabilitation and were then discharged home to use the devices for the remainder of the 6-month trial. Physiotherapist-participant contact occurred every 1-2 weeks using a health coaching approach, including technology support when required. Intervention datasheets were audited, and descriptive statistics used to report device use and support required.
RESULTS


Participants (mean (SD) age 70 (18) years; 49% neurological health conditions) used an average of 2 (SD 1) devices (98% used an activity monitor). Eight percent of physiotherapy contact included technology support with 30% provided remotely. Support addressed 845 issues categorised under initial set-up and instruction (27%), education and training (31%), maintenance (23%) and trouble-shooting (19%).
CONCLUSION


Digital devices can be used for home-based rehabilitation, but ongoing technology support is essential.  Clinical Trials Registry:  ACTRN12614000936628 IMPLICATIONS FOR REHABILITATION Digital device use at home to support long-term management of health conditions is likely to become increasingly important as the need for rehabilitation increases and rehabilitation resources become more limited. Technology support for set-up and ongoing device use is a critical enabler of home-based digital interventions. Health professionals delivering home-based digital interventions require sufficient training and equipment and may need to vary the mode (e.g., home visit vs. telephone or video conference) depending on the technology support required.",2020,We performed an evaluation of the support required for device use by participants randomised to the intervention group who received digitally-enabled rehabilitation in the post-hospital phase ( n  = 144).,['Participants (mean (SD) age 70 (18) years; 49% neurological health conditions'],"['standard rehabilitation, utilised eight digital devices (virtual reality videogames, activity monitors and handheld computer devices']",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C1136005', 'cui_str': 'Computers, Handheld'}]",[],,0.0423924,We performed an evaluation of the support required for device use by participants randomised to the intervention group who received digitally-enabled rehabilitation in the post-hospital phase ( n  = 144).,"[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hassett', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Maayken', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide,\xa0Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide,\xa0Australia.'}, {'ForeName': 'Sakina', 'Initials': 'S', 'LastName': 'Chagpar', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rabie', 'Affiliation': 'Liverpool Hospital, South Western Sydney Local Health District,\xa0Sydney, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'McCluskey', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health,\xa0The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney,\xa0Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide,\xa0Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1790679']
2711,32663093,"Unmet Social Needs and Adherence to Pediatric Weight Management Interventions: Massachusetts, 2017-2019.","Objectives.  To examine effects of unmet social needs on adherence to pediatric weight management intervention (PWMI). Methods.  We examined individual associations of positive screens for parental stress, parental depression, food insecurity, and housing insecurity with intervention adherence, and associations of 0, 1 or 2, and 3 or 4 unmet social needs with adherence, among children enrolled in a 2017-2019 comparative effectiveness trial for 2 high-intensity PWMIs in Massachusetts. Models were adjusted for child age, body mass index (BMI), parent BMI, and intervention arm. Results.  Families with versus without housing insecurity received a mean of 5.3 (SD = 8.0) versus 8.3 (SD = 10.9) contact hours ( P  < .01). There were no statistically significant differences in adherence for families reporting other unmet social needs. Children with 3 to 4 unmet social needs versus without received a mean of 5.2 (SD = 8.1) versus 9.2 (SD = 11.8) contact hours ( P  < .01). In fully adjusted models, those with housing insecurity attended a mean difference of -3.14 (95% confidence interval [CI] = -5.41, -0.88) hours versus those without. Those with 3 or 4 unmet social needs attended -3.74 (95% CI = -6.64, -0.84) hours less than those with none. Conclusions.  Adherence to PWMIs was lower among children with housing insecurity and in families with 3 or 4 unmet social needs. Addressing social needs should be a priority of PWMIs to improve intervention adherence and reduce disparities in childhood obesity. Trial Registration:  ClinicalTrials.gov identifier: NCT03012126.",2020,Adherence to PWMIs was lower among children with housing insecurity and in families with 3 or 4 unmet social needs.,"['children with housing insecurity and in families with 3 or 4 unmet social needs', 'children enrolled in a 2017-2019 comparative effectiveness trial for 2 high-intensity PWMIs in Massachusetts']",['pediatric weight management intervention (PWMI'],['Adherence to PWMIs'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0233497', 'cui_str': 'Insecurity'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2.0,0.105607,Adherence to PWMIs was lower among children with housing insecurity and in families with 3 or 4 unmet social needs.,"[{'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Atkins', 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Castro', 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Perkins', 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': ""O'Connor"", 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Sandel', 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}, {'ForeName': 'Elsie M', 'Initials': 'EM', 'LastName': 'Taveras', 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fiechtner', 'Affiliation': ""Micaela Atkins, Ines Castro, Meghan Perkins, Giselle O'Connor, and Man Luo are with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, Boston, MA. Mona Sharifi is with Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT. Megan Sandel is with Division of General Academic Pediatrics, Boston Medical Center, Boston. Lauren Fiechtner is with Department of Pediatrics, Division of General Academic Pediatrics and Division of Gastroenterology and Nutrition, MassGeneral Hospital for Children. Elsie M. Taveras is with Department of Pediatrics, Division of General Academic Pediatrics, MassGeneral Hospital for Children, and Department of Nutrition, Harvard T.\u2009H. Chan School of Public Health, Boston.""}]",American journal of public health,['10.2105/AJPH.2020.305772']
2712,32663102,Relieving exertional dyspnea during the 3-min constant speed shuttle test in patients with COPD with indacaterol/glycopyrronium  versus  tiotropium: the RED trial.,"BACKGROUND


Exertional dyspnea is a cardinal feature of chronic obstructive pulmonary disease (COPD) and a major cause of activity limitation. Although dual bronchodilation is more effective than bronchodilator monotherapy at improving resting pulmonary function, it is unclear to which extent this translates into superior relief of exertional dyspnea.
METHODS


We conducted a randomized controlled, double-blind, cross-over trial comparing indacaterol 110 µg/glycopyrronium 50 µg once daily (OD) with tiotropium 50 µg OD in patients with moderate to severe COPD and resting hyperinflation (functional residual capacity >120% of predicted value). The primary outcome was Borg dyspnea score at the end of a 3-min constant speed shuttle test after 3 weeks of treatment. Secondary outcomes included changes in Borg dyspnea score after the first dose of study medication, expiratory flows and lung volumes. Statistical analysis was conducted using a cross-over analysis of variance model with repeated measurements.
RESULTS


A total of 50 patients with COPD and a mean forced expiratory volume in 1 s of 54 ± 11% (mean ± SEM) predicted participated in the cross-over phase of the trial. Compared with baseline, there was a decrease in dyspnea after the first dose of medication with indacaterol/glycopyrronium [mean -1.00, 95% confidence interval (CI) -1.49 to -0.52] but not with tiotropium alone (mean -0.36, 95% CI -0.81 to 0.08). The reduction in dyspnea after the first dose was statistically significant between the two treatments (mean difference of -0.64, 95% CI -1.11 to -0.17). Despite indacaterol/glycopyrronium providing further bronchodilation and lung deflation throughout the trial, the reduction in dyspnea was not sustained at 3 weeks of treatment (mean between-treatment difference at 3 weeks of 0.09, 95% CI -0.44 to 0.61).
CONCLUSION


In comparison with bronchodilator monotherapy, indacaterol/glycopyrronium provided greater immediate exertional dyspnea relief, although this difference was not sustained after 3 weeks of therapy despite evidence of further bronchodilation and lung deflation. The reviews of this paper are available via the supplemental material section.",2020,"The reduction in dyspnea after the first dose was statistically significant between the two treatments (mean difference of -0.64, 95% CI -1.11 to -0.17).","['patients with moderate to severe COPD and resting hyperinflation (functional residual capacity >120% of predicted value', '50 patients with COPD and a mean forced expiratory volume in 1\u2009s of 54\u2009±\u200911% (mean\u2009±\u2009SEM) predicted participated in the cross-over phase of the trial', 'patients with COPD with']","['indacaterol/glycopyrronium  versus  tiotropium', 'bronchodilator monotherapy, indacaterol/glycopyrronium', 'indacaterol 110\u2009µg/glycopyrronium 50\u2009µg once daily (OD) with tiotropium', 'tiotropium']","['changes in Borg dyspnea score after the first dose of study medication, expiratory flows and lung volumes', 'reduction in dyspnea', 'Borg dyspnea score', 'Relieving exertional dyspnea', 'bronchodilation and lung deflation', 'immediate exertional dyspnea relief', 'dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0016815', 'cui_str': 'Functional residual capacity'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",50.0,0.452807,"The reduction in dyspnea after the first dose was statistically significant between the two treatments (mean difference of -0.64, 95% CI -1.11 to -0.17).","[{'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Beaulieu', 'Affiliation': 'Centre de recherche, Institut universitaire de cardiologie et de pneumologie de Québec; Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Jensen', 'Affiliation': 'Clinical Exercise and Respiratory Physiology Laboratory, Department of Kinesiology and Physical Education, Faculty of Education, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brouillard', 'Affiliation': 'Centre de recherche, Institut universitaire de cardiologie et de pneumologie de Québec; Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tracey', 'Affiliation': 'Clinical Exercise and Respiratory Physiology Laboratory, Department of Kinesiology and Physical Education, Faculty of Education, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vincent', 'Affiliation': ""Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Nadreau', 'Affiliation': 'Centre de recherche, Institut universitaire de cardiologie et de pneumologie de Québec; Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bernard', 'Affiliation': 'Centre de recherche, Institut universitaire de cardiologie et de pneumologie de Québec; Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bernard', 'Affiliation': 'Centre de recherche, Institut universitaire de cardiologie et de pneumologie de Québec; Université Laval, Québec, QC, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de pneumologie, Institut universitaire de cardiologie et de pneumologie de Québec, 2725 chemin Ste-Foy, QC G1V 4G5, Canada.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620939507']
2713,32671687,Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis.,"INTRODUCTION


FPG GOAL was a 24-week, open-label, treat-to-target randomized controlled trial which demonstrated that the optimal self-monitored fasting blood glucose (SM-FBG) target for most Chinese individuals with type 2 diabetes (T2D) using insulin glargine 100 IU/mL was 3.9-6.1 mmol/L. Individuals who achieved lower fasting plasma glucose (FPG) levels might achieve the target HbA1c of < 7% without increasing the risk of hypoglycemia.
METHODS


For this post hoc analysis, individuals were redivided into three groups based on their actual laboratory FPG levels at 24 weeks: level 1, ≤ 5.6 mmol/L; level 2, > 5.6 to ≤ 6.1 mmol/L; and level 3, > 6.1 to ≤ 7.0 mmol/L.
RESULTS


At week 24, 863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved FPG levels 1, 2, and 3, respectively. The proportion of individuals with HbA1c < 7% or HbA1c < 7% without hypoglycemia (≤ 3.9 or ≤ 3.0 mmol/L) was significantly higher in FPG levels 1 (p < 0.01) and 2 (p < 0.05) than in level 3. The least squares mean changes from baseline in HbA1c (- 1.77% and - 1.66% vs - 1.34%; both p < 0.001) and 2-h postprandial glucose (- 3.88 mmol/L and - 3.98 mmol/L vs - 3.22 mmol/L; both p < 0.05) were also significantly higher in FPG levels 1 and 2 compared with level 3. Linear regression analysis showed a moderate relationship between FPG and HbA1c levels at 24 weeks (r = 0.449).
CONCLUSIONS


Chinese individuals with T2D who achieved lower FPG levels with insulin glargine 100 IU/mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels. ClinicalTrials.gov identifier NCT02545842.",2020,mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels.,"['Individuals with Type\xa02 Diabetes', '863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved', 'Chinese individuals with type\xa02 diabetes (T2D) using']","['insulin glargine', 'Fasting Glucose Levels']","['FPG levels', 'actual laboratory FPG levels', 'hypoglycemia', '2-h postprandial glucose', 'fasting plasma glucose (FPG) levels', 'FPG and HbA1c levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",863.0,0.0347012,mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels.,"[{'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Minxiang', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Yunguang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China. ywying_1010@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01410-1']
2714,32671717,Screening and functional analysis of differentially expressed lncRNAs in rapid atrial pacing dog atrial tissue.,"PURPOSE


Atrial fibrillation (AF) is one of the most commonly sustained arrhythmias in clinical practice. Long non-coding RNAs (lncRNAs) are gene regulatory elements involved in the development of several diseases. We aimed to explore the expression characteristics of lncRNAs associated with AF.
METHODS


We randomly assigned 12 adult healthy mongrel dogs into a control group and an atrial pacing group. Atrial pacing stimulation was performed at a high frequency of 500 beats per min for 14 consecutive days in the atrial pacing group. HE and Masson staining were used to detect rapid atrial pacing induced atrial fibrosis. Total RNA extraction was performed on dog atrial tissues and was used for high-throughput sequencing of lncRNAs.
RESULTS


A total of 10,310 lncRNAs were detected, and 33 differentially expressed lncRNAs were screened. Among them, 19 lncRNAs were upregulated in the atrial pacing group, and 14 lncRNAs were downregulated. Gene Ontology (GO) classification, Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis, and interaction networks showed that AF-related lncRNAs participate in the regulation of AF in diverse biological processes, cellular components, molecular functions, signaling pathways, and complex interactions with miRNAs and mRNAs. Five differentially expressed lncRNAs were selected for RT-PCR validation, and the verification results were consistent with the results of lncRNA sequencing.
CONCLUSIONS


In summary, our study enhances our understanding of the biological functions of AF-related lncRNAs by screening and analyzing differentially expressed lncRNAs, and the results help to enrich the theoretical basis for the treatment of atrial fibrillation.",2020,Atrial pacing stimulation was performed at a high frequency of 500 beats per min for 14 consecutive days in the atrial pacing group.,"['A total of 10,310 lncRNAs were detected, and 33 differentially expressed lncRNAs were screened', '12 adult healthy mongrel dogs into a']",['control group and an atrial pacing group'],['Total RNA extraction'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1269316', 'cui_str': 'Mixed breed dog'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3839010', 'cui_str': 'Ribonucleic acid extraction technique'}]",12.0,0.021677,Atrial pacing stimulation was performed at a high frequency of 500 beats per min for 14 consecutive days in the atrial pacing group.,"[{'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Shangguan', 'Affiliation': ""Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Rukun', 'Initials': 'R', 'LastName': 'Cheng', 'Affiliation': ""Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Jiageng', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ""Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Baoshuai', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Scientific research, The Second Hospital of Tianjin Medical University, Tianjin, 300211, China.'}, {'ForeName': 'Enzhao', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi, Tianjin, 300211, People's Republic of China. liu_ezh@126.com.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Road, Hexi, Tianjin, 300211, People's Republic of China. liangxue19841219@126.com.""}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-020-00824-9']
2715,32671719,Cabozantinib for the Treatment of Advanced Hepatocellular Carcinoma: Current Data and Future Perspectives.,"Cabozantinib (Cabometyx ® ) is a potent multikinase inhibitor targeting the vascular endothelial growth factor (VEGF) receptor 2, the mesenchymal-epithelial transition factor (MET) receptor, and the ""anexelekto"" (AXL) receptor tyrosine kinase. It is approved for the treatment of advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since November 2018) and in the USA (since January 2019). The approval of cabozantinib was based on results of the randomized, placebo-controlled, phase 3 CELESTIAL trial in patients with unresectable HCC, who received one or two prior lines of treatment including sorafenib. At the second planned interim analysis, the trial was stopped, because the primary end point overall survival was clearly in favor for cabozantinib. Additionally, median progression-free survival was superior to placebo. The most common ≥ grade 3 relevant adverse events in patients with HCC treated with cabozantinib were palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea. In this review, current data on cabozantinib for the treatment of patients with advanced HCC, with a focus on the management of common adverse events and ongoing clinical trials, are discussed.",2020,"Additionally, median progression-free survival was superior to placebo.","['patients with advanced HCC', 'Advanced Hepatocellular Carcinoma', 'patients with unresectable HCC, who received one or two prior lines of treatment including', 'advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since\xa0November 2018) and in the USA (since January 2019']","['Cabozantinib (Cabometyx ® ', 'sorafenib', 'Cabozantinib', 'placebo']","['palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea', 'overall survival', 'median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C4237933', 'cui_str': 'Cabometyx'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.065429,"Additionally, median progression-free survival was superior to placebo.","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Trojan', 'Affiliation': 'Universitätsklinikum Frankfurt, Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. trojan@em.uni-frankfurt.de.'}]",Drugs,['10.1007/s40265-020-01361-5']
2716,32666396,Modified Encircling Scleral Buckle Technique Without Subretinal Fluid Drainage or Retinopexy.,"INTRODUCTION


Scleral buckling (SB) tends to be more challenging and time-consuming for compared to the pars plana vitrectomy for repairing rhegmatogenous retinal detachments (RRDs). This study characterizes a novel and simplified technique for SB.
METHODS


In this single-masked randomized interventional study, patients with RRDs who were eligible for SB were randomly assigned to either the standard (S) or modified (M) technique of SB. In the modified approach, neither intraoperative break localization nor cryopexy or subretinal fluid drainage was done. A large tire (276/279) was placed where preoperative retinal breaks had been localized with a 240 encircling band placed for support of the remaining retina. Patients were followed for 12 months and the primary outcomes were differences between the surgical groups in operative time, anatomical success, visual acuity, and complication rate.
RESULTS


Thirty-six eyes were included in the study (18 in each arm). There were no differences in baseline patient demographics or characteristics including gender, age, lens and macular status, preoperative vision, and symptom duration. The mean length of surgery was 72.2 ± 13.2 and 56.2 ± 9.5 min in groups S and M, respectively (P = 0.001). Complete retinal reattachment at the end of month 12 after single surgery was 80.6% overall; 77.8% (14/18) in group S and 83.3% (15/18) in group M (P > 0.999). After 12 months, both groups achieved similar final best-corrected visual acuity (BCVA): 0.26 ± 0.23 and 0.23 ± 0.17 logMAR in groups S and M, respectively (P = 0.231). Controlling for preoperative BCVA on ANCOVA testing, there were no significant differences in visual improvement between the two groups [F (1,26) = 0.02, P = 0.966 (95% CI) - 0.128 to 0.123)]. Scleral perforation (2:1), vitreous hemorrhage (3:2), and transient rise of intraocular pressure (3:4) all occurred at a low and similar rate between the two groups (S:M).
CONCLUSION


Modified SB technique was non-inferior compared to the standard approach for anatomical and visual outcomes. Shortening surgical time while maintaining low complication rates makes this an appropriate approach to SB, especially for vitreoretinal surgery trainees.",2020,"Shortening surgical time while maintaining low complication rates makes this an appropriate approach to SB, especially for vitreoretinal surgery trainees.","['Thirty-six eyes were included in the study (18 in each arm', 'patients with RRDs who were eligible for SB']","['pars plana vitrectomy', 'standard (S) or modified (M) technique of SB', 'Scleral buckling (SB', 'Modified Encircling Scleral Buckle Technique Without Subretinal Fluid Drainage or Retinopexy', 'Modified SB technique']","['Scleral perforation (2:1), vitreous hemorrhage (3:2), and transient rise of intraocular pressure', 'similar final best-corrected visual acuity (BCVA', 'visual improvement', 'Complete retinal reattachment', 'mean length of surgery', 'baseline patient demographics or characteristics including gender, age, lens and macular status, preoperative vision, and symptom duration', 'operative time, anatomical success, visual acuity, and complication rate']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0036411', 'cui_str': 'Scleral buckling'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036411', 'cui_str': 'Scleral buckling'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1868761', 'cui_str': 'Retinopexy'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",36.0,0.258528,"Shortening surgical time while maintaining low complication rates makes this an appropriate approach to SB, especially for vitreoretinal surgery trainees.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mafi', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mirghorbani', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ghahvehchian', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S Saeed', 'Initials': 'SS', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Riazi-Esfahani', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khalili Pour', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Khojasteh', 'Affiliation': 'Department of Ophthalmology, Farabi Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran. khojaste_hasan@yahoo.com.'}, {'ForeName': 'Bobeck S', 'Initials': 'BS', 'LastName': 'Modjtahedi', 'Affiliation': 'Department of Ophthalmology, Southern California Permanente Medical Group, Baldwin Park, CA, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00279-1']
2717,32666402,Associations between commonly used patient-reported outcome tools in postpartum depression clinical practice and the Hamilton Rating Scale for Depression.,"The objective of this study is to explore the associations between the patient-reported Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17) in order to facilitate clinical decision-making. An integrated efficacy dataset of three randomized placebo-controlled trials (NCT02614547, NCT02942004, and NCT02942017) evaluating brexanolone injection, a neuroactive steroid chemically identical to allopregnanolone, in women with postpartum depression was used for this post hoc analysis. Data were pooled across treatment arms. Associations were assessed at day 30 (end-of-trial follow-up). Pearson correlation assessed the relationship between EPDS and PHQ-9 item and total scores and HAMD-17 total score. Cohen's kappa assessed agreement of EPDS remission (score < 10) and PHQ-9 remission (score < 5) with HAMD-17 remission (score ≤ 7). Ordinary least squares (OLS) regression models were used to develop equations estimating HAMD-17 total scores from EPDS and PHQ-9 scores, respectively. The total scores showed large correlations (HAMD-17/EPDS: r = 0.71, p < 0.001; HAMD-17/PHQ-9: r = 0.75, p < 0.001). Individual EPDS and PHQ-9 items significantly correlated (r= 0.35 to 0.67, all p < 0.001) with HAMD-17 total score. EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%. OLS models yielded the following equations: HAMD-17 total = 2.66 + (EPDS total × 0.87) and HAMD-17 total = 3.99 + (PHQ-9 total × 0.97). There were large and statistically significant associations between patient-reported outcomes (EPDS, PHQ-9) and clinician-reported outcomes (HAMD-17) as clinical improvements were associated with patient-reported symptom improvement. These results provide tools to help translate clinical trial data to clinical practice, thus aiding shared decision-making for this critical population.",2020,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,['women with postpartum depression'],"['brexanolone injection', 'placebo']","['PHQ-9 remission', 'Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17', 'EPDS and PHQ-9 item and total scores and HAMD-17 total score', 'EPDS remission', 'Hamilton Rating Scale for Depression', 'Individual EPDS and PHQ-9 items']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]","[{'cui': 'C4765158', 'cui_str': 'brexanolone Injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0698929,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,"[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Gerbasi', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Eldar-Lissai', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Acaster', 'Affiliation': 'Acaster Lloyd Consulting Ltd., London, UK.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Fridman', 'Affiliation': 'AMF Consulting, Los Angeles, CA, USA.'}, {'ForeName': 'Vijayveer', 'Initials': 'V', 'LastName': 'Bonthapally', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodgkins', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kanes', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina School of Medicine, 101 Manning Drive, Chapel Hill, NC, 27514, USA. samantha_meltzer-brody@med.unc.edu.'}]",Archives of women's mental health,['10.1007/s00737-020-01042-y']
2718,32586100,Prognostic evaluation of serum long non-coding RNA H19 for endoscopic keyhole surgery or craniotomy in glioma.,"BACKGROUND


Our study aims to explore the effect of serum long non-coding RNA (lncRNA) H19 level on the long-term prognosis of endoscopic keyhole surgery or craniotomy for glioma.
METHODS


A total of 264 glioma patients were selected. Patients were randomly divided into the Craniotomy-high H19 group, the Craniotomy-low H19 group, the Endoscopic keyhole surgery-high H19 group and the Endoscopic keyhole surgery-low H19 group.
RESULTS


Compared with adjacent tissues (5.19 ± 1.42), H19 level in cancer tissues (7.45 ± 1.60) and serum (6.44 ± 1.57) was significantly increased ( P  <   0.05). Compared with serum, H19 level in cancer tissues was significantly increased ( P  <   0.05). Pearson correlation analysis found that the relative expression level of serum H19 in glioma patients was positively correlated with cancer tissues ( r Pearson  = 0.547,  P  <   0.001), but had no significant correlation with adjacent tissues ( r Pearson  = 0.126,  P   =    0.207). The expression of H19 in serum was significantly related to WHO grade ( r Pearson  = 0.514,  P  <   0.001). Compared with the Endoscopic keyhole surgery-high H19 group and the Endoscopic keyhole surgery-low H19 group, the survival rate of patients in the Craniotomy-high H19 group (χ 2  = 17.115 and log-rank  P  <   0.001; χ 2  = 18.406 and log-rank  P  <   0.001) and the Craniotomy-low H19 group was significantly reduced (χ 2  = 15.007 and log-rank  P  <   0.001; χ 2  = 16.121 and log-rank  P  <   0.001). Cox regression results showed that serum H19 level, craniotomy and WHO grade were risk factors for glioma. When H19 level was lower than 6.28, the 30-month survival rate of patients with the endoscopic keyhole surgery was 100%.
CONCLUSION


For patients with low H19 level (<5.36), both endoscopic keyhole surgery and craniotomy are available, otherwise, endoscopic keyhole surgery is more recommended.",2020,<   0.001) and the Craniotomy-low H19 group was significantly reduced (χ 2  = 15.007 and log-rank  P  ,"['endoscopic keyhole surgery or craniotomy in glioma', '264 glioma patients were selected']","['Craniotomy-high H19 group, the Craniotomy-low H19 group, the Endoscopic keyhole surgery-high H19 group and the Endoscopic keyhole surgery-low H19 group', 'serum long non-coding RNA (lncRNA', 'endoscopic keyhole surgery or craniotomy']","['survival rate', 'serum H19 level, craniotomy and WHO grade were risk factors for glioma', 'H19 level in cancer tissues', 'expression of H19 in serum', '30-month survival rate']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",264.0,0.043746,<   0.001) and the Craniotomy-low H19 group was significantly reduced (χ 2  = 15.007 and log-rank  P  ,"[{'ForeName': 'Likui', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Neurosurgery, Kunshan Hospital of Traditional Chinese Medicine, Kunshan Affiliated Hospital of Nanjing University of Chinese Medicine, Suzhou, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine, Suzhou, China.'}, {'ForeName': 'Zhengquan', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Annals of clinical biochemistry,['10.1177/0004563220941888']
2719,32053557,Myocardial Function during Low versus Intermediate Tidal Volume Ventilation in Patients without Acute Respiratory Distress Syndrome.,"BACKGROUND


Mechanical ventilation with low tidal volumes has the potential to mitigate ventilation-induced lung injury, yet the clinical effect of tidal volume size on myocardial function has not been clarified. This cross-sectional study investigated whether low tidal volume ventilation has beneficial effects on myocardial systolic and diastolic function compared to intermediate tidal volume ventilation.
METHODS


Forty-two mechanically ventilated patients without acute respiratory distress syndrome (ARDS) underwent transthoracic echocardiography after more than 24 h of mechanical ventilation according to the Protective Ventilation in Patients without ARDS (PReVENT) trial comparing a low versus intermediate tidal volume strategy. The primary outcome was left ventricular and right ventricular myocardial performance index as measure for combined systolic and diastolic function, with lower values indicating better myocardial function and a right ventricular myocardial performance index greater than 0.54 regarded as the abnormality threshold. Secondary outcomes included specific systolic and diastolic parameters.
RESULTS


One patient was excluded due to insufficient acoustic windows, leaving 21 patients receiving low tidal volumes with a tidal volume size (mean ± SD) of 6.5 ± 1.8 ml/kg predicted body weight, while 20 patients were subjected to intermediate tidal volumes receiving a tidal volume size of 9.5 ± 1.6 ml/kg predicted body weight (mean difference, -3.0 ml/kg; 95% CI, -4.1 to -2.0; P < 0.001). Right ventricular dysfunction was reduced in the low tidal volume group compared to the intermediate tidal volume group (myocardial performance index, 0.41 ± 0.13 vs. 0.64 ± 0.15; mean difference, -0.23; 95% CI, -0.32 to -0.14; P < 0.001) as was left ventricular dysfunction (myocardial performance index, 0.50 ± 0.17 vs. 0.63 ± 0.19; mean difference, -0.13; 95% CI, -0.24 to -0.01; P = 0.030). Similarly, most systolic parameters were superior in the low tidal volume group compared to the intermediate tidal volume group, yet diastolic parameters did not differ between both groups.
CONCLUSIONS


In patients without ARDS, intermediate tidal volume ventilation decreased left ventricular and right ventricular systolic function compared to low tidal volume ventilation, although without an effect on diastolic function.",2020,"In patients without ARDS, intermediate tidal volume ventilation decreased left ventricular and right ventricular systolic function compared to low tidal volume ventilation, although without an effect on diastolic function.","['Forty-two mechanically ventilated patients without acute respiratory distress syndrome (ARDS', 'Patients without Acute Respiratory Distress Syndrome']","['Low versus Intermediate Tidal Volume Ventilation', 'transthoracic echocardiography after more than 24 h of mechanical ventilation according to the Protective Ventilation in Patients without ARDS', 'low tidal volume ventilation']","['Myocardial Function', 'left ventricular and right ventricular myocardial performance index as measure for combined systolic and diastolic function, with lower values indicating better myocardial function and a right ventricular myocardial performance index', 'body weight', 'diastolic parameters', 'Right ventricular dysfunction', 'tidal volume size (mean ± SD', 'left ventricular dysfunction', 'myocardial systolic and diastolic function', 'specific systolic and diastolic parameters', 'intermediate tidal volume ventilation decreased left ventricular and right ventricular systolic function', 'diastolic function']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242707', 'cui_str': 'Right ventricular dysfunction'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",42.0,0.0596384,"In patients without ARDS, intermediate tidal volume ventilation decreased left ventricular and right ventricular systolic function compared to low tidal volume ventilation, although without an effect on diastolic function.","[{'ForeName': 'Thomas G V', 'Initials': 'TGV', 'LastName': 'Cherpanath', 'Affiliation': 'From the Departments of Intensive Care Medicine (T.G.V.C., F.D.S., N.P.J., W.K.L.) Cardiology (B.J.B., R.H.d.B.-B.) the Laboratory of Experimental Intensive Care and Anesthesiology (M.J.S.); Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands the Department of Intensive Care, Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, The Netherlands (R.M.D) the Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus, Dresden, Germany (M.G.d.A.) the Department of Surgical Sciences and Integrated Diagnostics, Scientific Institute for Research, Hospitalization and Health Care, San Martino IST, University of Genoa, Genoa, Italy (P.P.) the Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil (A.S.N.) the Department of Intensive Care Medicine, Erasmus Medical Center, Rotterdam, The Netherlands (J.A.B.G.).'}, {'ForeName': 'Fabienne D', 'Initials': 'FD', 'LastName': 'Simonis', 'Affiliation': ''}, {'ForeName': 'Berto J', 'Initials': 'BJ', 'LastName': 'Bouma', 'Affiliation': ''}, {'ForeName': 'Rianne H', 'Initials': 'RH', 'LastName': 'de Bruin-Bon', 'Affiliation': ''}, {'ForeName': 'Rogier M', 'Initials': 'RM', 'LastName': 'Determann', 'Affiliation': ''}, {'ForeName': 'Nicole P', 'Initials': 'NP', 'LastName': 'Juffermans', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': ''}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': ''}, {'ForeName': 'Johan A B', 'Initials': 'JAB', 'LastName': 'Groeneveld', 'Affiliation': ''}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': ''}, {'ForeName': 'Wim K', 'Initials': 'WK', 'LastName': 'Lagrand', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003175']
2720,32663278,Impact of evening alcohol consumption on nocturnal autonomic and cardiovascular function in adult men and women: A dose-response laboratory investigation.,"STUDY OBJECTIVES


To investigate the dose-dependent impact of moderate alcohol intake on sleep-related cardiovascular (CV) function, in adult men and women.
METHODS


Twenty-six healthy adults (30-60y; 11 women) underwent three nights of laboratory polysomnographic (PSG) recordings in which different doses of alcohol (low: 1 standard drink for women and 2 drinks for men; high: 3 standard drinks for women and 4 drinks for men; placebo: no-alcohol) were administered in counterbalanced order before bedtime. These led to bedtime average breath alcohol levels of up to 0.02% for the low doses and around 0.05% for the high doses. Autonomic and CV function were evaluated using electrocardiography, impedance cardiography, and beat-to-beat blood pressure monitoring.
RESULTS


Pre-sleep alcohol ingestion resulted in an overall increase in nocturnal heart rate (HR), suppressed total and high-frequency (vagal) HR variability, reduced baroreflex sensitivity, and increased sympathetic activity, with effects pronounced after high-dose alcohol ingestion (p's<0.05); these changes followed different dose- and measure-dependent nocturnal patterns in men and women. Systolic blood pressure showed greater increases during the morning hours of the high-alcohol dose night compared to the low-alcohol dose night and placebo, in women only (p's<0.05).
CONCLUSIONS


Acute evening alcohol consumption, even at moderate doses, has marked dose- and time-dependent effects on sleep CV regulation in adult men and women. Further studies are needed to evaluate the potential CV risk of repeated alcohol-related alterations in night-time CV restoration in healthy individuals and in those at high risk for CV diseases, considering sex and alcohol dose and time effects.",2020,"Systolic blood pressure showed greater increases during the morning hours of the high-alcohol dose night compared to the low-alcohol dose night and placebo, in women only (p's<0.05).
","['adult men and women', 'Twenty-six healthy adults (30-60y; 11 women']","['placebo', 'moderate alcohol intake', 'evening alcohol consumption', 'laboratory polysomnographic (PSG) recordings in which different doses of alcohol (low: 1 standard drink for women and 2 drinks for men; high: 3 standard drinks for women and 4 drinks for men; placebo']","['nocturnal autonomic and cardiovascular function', 'nocturnal heart rate (HR), suppressed total and high-frequency (vagal) HR variability, reduced baroreflex sensitivity, and increased sympathetic activity', 'Autonomic and CV function', 'sleep CV regulation', 'bedtime average breath alcohol levels', 'Systolic blood pressure', 'sleep-related cardiovascular (CV) function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",26.0,0.0537086,"Systolic blood pressure showed greater increases during the morning hours of the high-alcohol dose night compared to the low-alcohol dose night and placebo, in women only (p's<0.05).
","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'de Zambotti', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Forouzanfar', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Javitz', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Goldstone', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Claudatos', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Alschuler', 'Affiliation': 'Center for Interdisciplinary Brain Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Baker', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Colrain', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA, USA.'}]",Sleep,['10.1093/sleep/zsaa135']
2721,32663286,"Feasibility, Acceptability, and Preliminary Efficacy of an App-Based Mindfulness-Meditation Program Among Older Adults.","BACKGROUND AND OBJECTIVES


Few studies have focused on the utility of mindfulness-meditation for well-being in older adults. The present study investigated the feasibility, acceptability, and preliminary efficacy of an app-based mindfulness-meditation program among older adults.
RESEARCH DESIGN AND METHODS


A community-based sample of 46 participants aged between 63 and 81 (M = 70.85, SD = 4.70) engaged with a 30-day app-based mindfulness-meditation program for 10-minutes daily on their smartphones. Each meditation session comprised focusing on the breath, mentally scanning the body, monitoring the mind's activity, and cultivating a nonjudgmental orientation toward experiences. Participants completed questionnaires at baseline, day 10, and day 30.
RESULTS


On average, participants completed 25 sessions and almost 4 hours of application use across the 30-days. Results of linear mixed effects models showed significant improvements in positive affect, negative affect, and life satisfaction across the study interval, but no meaningful change in total mindfulness or perceived stress. Furthermore, relative to high levels of smartphone efficacy, low smartphone efficacy was associated with higher perceived stress and negative affect, and less life satisfaction at baseline; and steeper improvements on these outcomes across the study interval. On average, older adults rated the app-based mindfulness-meditation training as interesting, enjoyable, valuable, and useful.
DISCUSSION AND IMPLICATIONS


The findings provide preliminary support for the feasibility and acceptability of an app-based mindfulness-meditation program with community-dwelling older adults and demonstrate potential benefits for well-being. Results suggest the value of further research investigating the efficacy of digital mindfulness-meditation interventions for older adults via larger randomized-controlled trials.",2020,The findings provide preliminary support for the feasibility and acceptability of an app-based mindfulness-meditation program with community-dwelling older adults and demonstrate potential benefits for well-being.,"['46 participants aged between 63 and 81 (M = 70.85, SD = 4.70) engaged with a 30-day app-based mindfulness-meditation program for 10-minutes daily on their smartphones', 'Older Adults', 'older adults', 'with community-dwelling older adults']","['digital mindfulness-meditation interventions', 'app-based mindfulness-meditation program', 'App-Based Mindfulness-Meditation Program']","['life satisfaction', 'positive affect, negative affect, and life satisfaction', 'total mindfulness or perceived stress']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",46.0,0.0265594,The findings provide preliminary support for the feasibility and acceptability of an app-based mindfulness-meditation program with community-dwelling older adults and demonstrate potential benefits for well-being.,"[{'ForeName': 'Leeann', 'Initials': 'L', 'LastName': 'Mahlo', 'Affiliation': 'College of Education, Psychology and Social Work, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Windsor', 'Affiliation': 'College of Education, Psychology and Social Work, Flinders University, Adelaide, Australia.'}]",The Gerontologist,['10.1093/geront/gnaa093']
2722,32663379,Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study.,"BACKGROUND


Pancreatic cancer patients are at risk for venous thromboembolism (VTE); the value of thromboprophylaxis has not been definitively established.
METHODS


This trial randomized cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to rivaroxaban 10 mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients. The primary efficacy endpoint was the composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death. The primary safety endpoint was International Society on Thrombosis and Haemostasis-defined major bleeding.
RESULTS


In total, 49/1080 (4.5%) patients enrolled had baseline VTE on screening, with higher rates (24/362 [6.6%]) in pancreatic cancer and they were not randomized. Of 841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period. The primary endpoint occurred in 13/135 (9.6%) patients in the rivaroxaban group and in 18/138 (13.0%) in the placebo group (hazard ratio [HR] = 0.70; 95% CI, 0.34-1.43; P = .328) in up-to-day-180 period and 5/135 (3.7%) patients receiving rivaroxaban and 14/138 (10.1%) receiving placebo in the intervention period (HR = 0.35; 95% CI, 0.13-0.97; P = .034). Major bleeding was similar (2 [1.5%] receiving rivaroxaban and 3 [2.3%] receiving placebo). Correlative biomarker studies demonstrated significant decline in D-dimer (weeks 8 and 16) in patients randomized to rivaroxaban compared to placebo (P < .01).
CONCLUSIONS


In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period. During the intervention period, however, rivaroxaban substantially reduced VTE without increasing major bleeding, suggesting benefit of rivaroxaban prophylaxis in this setting.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02555878.",2020,"In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period.","['ambulatory patients with pancreatic cancer', 'cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to', 'Pancreatic cancer patients', 'pancreatic cancer patients', '841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period', 'ambulatory pancreatic cancer patients']","['rivaroxaban 10 mg or placebo', 'placebo', 'Rivaroxaban thromboprophylaxis', 'rivaroxaban']","['composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death', 'Major bleeding', 'International Society on Thrombosis and Haemostasis-defined major bleeding', 'VTE or VTE-related death']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",841.0,0.591116,"In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period.","[{'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Vadhan-Raj', 'Affiliation': 'The UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.'}, {'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust & Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Venerito', 'Affiliation': 'Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum, Magdeburg, Germany.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Overman', 'Affiliation': 'The UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'The UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.'}, {'ForeName': 'Ujjwala', 'Initials': 'U', 'LastName': 'Vijapurkar', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Simrati', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, USA.'}]",Cancer medicine,['10.1002/cam4.3269']
2723,32663382,Hands-off: Study protocol of a two-armed randomized controlled trial of a web-based self-help tool to reduce problematic pornography use.,"Background and Aims


The past-year prevalence of problematic pornography use (PPU) was 1-6% in adult populations. As a result of treatment obstacles and barriers, such as unaffordable treatments, only a minority of problematic pornography users may seek treatment. Having a free, online, self-help program may overcome treatment barriers and may help those individuals who cannot receive traditional or offline treatment for PPU. Although the effectiveness of such online programs reducing substance use and problematic gambling have been reported, no prior study has examined the efficacy of an online self-help intervention aiming to reduce PPU.
Methods


This two-armed randomized controlled trial (RCT) will examine the effectiveness of an online self-help program (Hands-off) to reduce PPU, while also considering psychopathological comorbidities. The six-week intervention condition includes six core modules developed to reduce PPU based on motivational interviewing, cognitive behavioral therapy, mindfulness, and wise social-psychological intervention techniques. The target sample size is 242 participants. Self-report questionnaires will be administered at baseline, right after the end of the intervention, at one-month, and three-month follow-ups after the end of the intervention. The primary outcome will be the level of PPU. Secondary outcomes will include pornography use frequency, pornography craving, pornography use-avoidance self-efficacy, sex mindset, sexual satisfaction, negative and positive emotions, and life satisfaction. Data will be analyzed on an intention-to-treat basis using linear mixed models.
Results


Results will be reported at conferences and published in a scientific peer-reviewed journal. The participants will be sent a lay-person-friendly summary of the results via e-mail.",2020,The past-year prevalence of problematic pornography use (PPU) was 1-6% in adult populations.,['242 participants'],"['PPU based on motivational interviewing, cognitive behavioral therapy, mindfulness, and wise social-psychological intervention techniques']","['pornography use frequency, pornography craving, pornography use-avoidance self-efficacy, sex mindset, sexual satisfaction, negative and positive emotions, and life satisfaction', 'level of PPU']",[],"[{'cui': 'C0032702', 'cui_str': 'Pornography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032702', 'cui_str': 'Pornography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0756885,The past-year prevalence of problematic pornography use (PPU) was 1-6% in adult populations.,"[{'ForeName': 'Beáta', 'Initials': 'B', 'LastName': 'Bőthe', 'Affiliation': '1Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': '3Swiss Research Institute for Public Health and Addiction ISGF, Associated to the University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': '3Swiss Research Institute for Public Health and Addiction ISGF, Associated to the University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Demetrovics', 'Affiliation': '1Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Orosz', 'Affiliation': '4Department of Psychology, Stanford University, Stanford, CA, USA.'}]",Journal of behavioral addictions,['10.1556/2006.2020.00037']
2724,32663699,A randomized control trial of activity scheduling for caring for older adults with dementia and its impact on their spouse care-givers.,"INTRODUCTION


Participating in meaningful activities is important for any individual's wellbeing. Activity scheduling enables older adults with dementia and their spouse caregivers to structure their activities in accordance with the things they value.
METHODS


In examining the effectiveness of activity scheduling, this report details the results of a 12-week single-blinded randomized control trial using a parallel group experimental design.
RESULTS


From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study. The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively. Moreover, there were significant differences between the groups indicated that over time, the experimental group showed an improvement with regard to alleviating the role of caring, with Cohen's d = .64, and alleviating disruptive and depressive behavior, with an effect size of .45 and .50 respectively. The number of caring hours needed dropped from 6.98 to 5.98 h in the experimental group.
DISCUSSION & CONCLUSION


There were more activities that older adults with dementia and their spouse caregivers would like to do, and could participate in, than we had expected. Activity scheduling can facilitate their participation. This is a very important topic as non-pharmacological interventions are needed for this even-growing segment of the population.",2020,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","['older adults with dementia and its impact on their spouse care-givers', 'older adults with dementia and their spouse caregivers', 'From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study']",[],"['number of caring hours needed', 'alleviating disruptive and depressive behavior']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0087015', 'cui_str': 'Spouse Caregivers'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0283988,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department, Kowloon Hospital, Hong Kong.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Chung Hok Elderly Centre, Women's Welfare Club Western District, Hong Kong.""}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Tai Po Integrated Service for Senior Citizens, The Salvation Army Hong Kong & Macau Command, Hong Kong.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104167']
2725,32663820,Design and Baseline Characteristics of the Chlorthalidone in Chronic Kidney Disease (CLICK) Trial.,"BACKGROUND


Hypertension often accompanies chronic kidney disease (CKD), and diuretics are widely prescribed to reduce blood pressure (BP). Chlorthalidone (CTD) is a thiazide-like diuretic and an effective antihypertensive drug, yet little data exist to support its use in treating hypertension in individuals with advanced CKD.
METHODS


Chlorthalidone in Chronic Kidney Disease (CLICK) is a phase II, single-institution, multicenter, double-blind randomized control trial to test the hypothesis that CTD improves BP, through reduction of extracellular fluid volume, and results in target organ protection in patients with stage 4 CKD and poorly controlled hypertension. After a single-blind placebo run-in for 2 weeks and confirmation of hypertension by 24-h ambulatory blood pressure (ABP), patients are randomized to either placebo or CTD 12.5 mg once daily (QD) followed by dose escalation. Randomization is stratified by prior loop diuretic use, and the double-blind phase lasts 12 weeks. With a total of 160 patients, the study will have ≥80% power to detect a 6 mm Hg difference in systolic 24-h ABP between the 2 treatment groups.
RESULTS


Between June 2016 and October 2019, 131 patients have been randomized. The baseline characteristics are as follows: average age 65.8 years, 79% men, 36% Black, 79% with diabetes, mean eGFR 23.2 mL/min/1.73 m2, median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg.
CONCLUSION


Among patients with stage 4 CKD and uncontrolled hypertension, CLICK should answer the question whether CTD is safe and effective.",2020,"median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg.
","['patients with stage 4 CKD and poorly controlled hypertension', '160 patients', 'individuals with advanced CKD', 'patients with stage 4 CKD and uncontrolled hypertension', 'Chronic Kidney Disease (CLICK) Trial', 'Between June 2016 and October 2019, 131 patients have been randomized', 'follows: average age 65.8 years, 79% men, 36% Black, 79% with diabetes, mean eGFR 23.2 mL/min/1.73 m2', 'Chronic Kidney Disease (CLICK']","['Chlorthalidone (CTD', 'CTD', 'placebo or CTD', 'Chlorthalidone', 'placebo']","['blood pressure (BP', 'systolic 24-h ABP', 'median urine albumin/creatinine ratio 923 mg/g, average number of BP medications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",160.0,0.405279,"median urine albumin/creatinine ratio 923 mg/g, average number of BP medications 3.4, 60% on loop diuretics, and 24-h ABP averaged 141.7/73.8 mm Hg.
","[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA, ragarwal@iu.edu.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Cramer', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Balmes-Fenwick', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Arjun D', 'Initials': 'AD', 'LastName': 'Sinha', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Fangqian', 'Initials': 'F', 'LastName': 'Ouyang', 'Affiliation': 'Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Wanzhu', 'Initials': 'W', 'LastName': 'Tu', 'Affiliation': 'Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}]",American journal of nephrology,['10.1159/000508700']
2726,32663852,Is perioperative antibiotic necessary in straightforward implant placement procedures?,"The purpose of this non-random retrospective cohort study was to evaluate the impact of prophylactic antibiotic on early outcomes including postoperative pain, swelling, bleeding and cyanosis in patients undergoing dental implant placement before prosthetic loading. Seventy-five patients (45 males, 30 females) whose dental implant placement were completed, included to the study. Patients used prophylactic antibiotics were defined as the experimental group and those who did not, were defined as the control group. The experimental group received 2 g amoxicillin + clavulanic acid 1 h preoperatively and 1 g amoxicillin + clavulanic acid twice a day for 5 days postoperatively while the control group had received no prophylactic antibiotic therapy perioperatively. Data on pain, swelling, bleeding, cyanosis, flap dehiscence, suppuration and implant failure were analyzed on postoperative days 2, 7, and 14 and week 12. No statistically significant difference was detected between the two groups with regard to pain and swelling on postoperative days 2, 7, and 14 and week 12 ( p >0.05), while the severity of pain and swelling were greater on day 2 compared to day 7 and 14 and week 12 in both groups ( p =0.001 and p <0.05, respectively). Similarly, no significant difference was found between the two groups with regard to postoperative bleeding and cyanosis. Although flap dehiscence was more severe on day 7 in the experimental group, no significant difference was found between the two groups with regard to the percentage of flap dehiscence assessed at other time points. Within limitations of the study, it has been demonstrated that antibiotic use has no effect on implant failure rates in dental implant surgery with a limited number of implants. We conclude that perioperative antibiotic use may not be required in straightforward implant placement procedures. Further randomized control clinical studies with higher numbers of patients and implants are needed to substantiate our findings.",2020,"No statistically significant difference was detected between the two groups with regard to pain and swelling on postoperative days 2, 7, and 14 and week 12 ( p >0.05), while the severity of pain and swelling were greater on day 2 compared to day 7 and 14 and week 12 in both groups ( p =0.001 and p <0.05, respectively).","['patients undergoing dental implant placement before prosthetic loading', 'Seventy-five patients (45 males, 30 females) whose dental implant placement were completed, included to the study']","['amoxicillin + clavulanic acid 1 h preoperatively and 1 g amoxicillin + clavulanic acid', 'prophylactic antibiotic therapy perioperatively', 'prophylactic antibiotic']","['postoperative pain, swelling, bleeding and cyanosis', 'percentage of flap dehiscence', 'pain and swelling', 'pain, swelling, bleeding, cyanosis, flap dehiscence, suppuration and implant failure', 'prophylactic antibiotics', 'postoperative bleeding and cyanosis', 'flap dehiscence', 'severity of pain and swelling', 'implant failure rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0010520', 'cui_str': 'Cyanosis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",75.0,0.0373353,"No statistically significant difference was detected between the two groups with regard to pain and swelling on postoperative days 2, 7, and 14 and week 12 ( p >0.05), while the severity of pain and swelling were greater on day 2 compared to day 7 and 14 and week 12 in both groups ( p =0.001 and p <0.05, respectively).","[{'ForeName': 'Elçin', 'Initials': 'E', 'LastName': 'Bedeloğlu', 'Affiliation': 'Istanbul Aydin University, Department of Oral and Maxillofacial Surgery.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yalçın', 'Affiliation': 'Gaziantep University Oral and Maxillofacial Surgery Üniversite Blv., Diş Hekimliği Fakültesi, 27310 Şehitkamil/Gaziantep TURKEY Gaziantep Gaziantep 27310 Gaziantep University, Department of Oral and Maxillofacial Surgery.'}, {'ForeName': 'Cenker Zeki', 'Initials': 'CZ', 'LastName': 'Koyuncuoğlu', 'Affiliation': 'Istanbul Aydin University, Department of Periodontology.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00282']
2727,32663909,"Randomized, Double-Blind, Placebo-Controlled Trial of the mGlu2/3 Negative Allosteric Modulator Decoglurant in Partially Refractory Major Depressive Disorder.","OBJECTIVE


To assess putative antidepressant and procognitive effects of decoglurant, a selective metabotropic glutamate receptor type 2/3 (mGlu2/3) negative allosteric modulator, as adjunctive treatment to selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs) in patients with partially refractory major depressive disorder (MDD), diagnosed using DSM-IV-TR criteria.
METHODS


This randomized, placebo-controlled, double-blind, multicenter phase 2 trial consisted of 4 weeks' screening, 6 weeks' treatment, and 8 weeks' follow-up between September 2011 and June 2014. Individuals with Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 25 and Clinical Global Impressions-Severity of Illness scale score ≥ 4, despite up to 2 adequate trials of an SSRI/SNRI and compliance confirmed by positive SSRI/SNRI blood levels, were randomized to decoglurant 5 mg (n = 101), 15 mg (n = 102), or 30 mg (n = 55) daily or placebo (n = 99) as adjunct to ongoing treatment with 1 SSRI/SNRI. An adaptive design was used with an interim analysis after 30 patients in each group had received 6 weeks' treatment. The primary outcome variable was change in MADRS total score from baseline to end of treatment. Primary assessments were performed by fully blinded centralized raters.
RESULTS


Of 357 participants, 310 completed 6 weeks' treatment. At 6 weeks, no significant differences between any active treatment arm and placebo in reducing MADRS total score or response or remission rates were observed. Decoglurant exerted no significant effects on Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores or on secondary measures of mood and functioning. A relatively high placebo response was observed, which may have constrained the ability to detect treatment effects. No deaths occurred; few patients reported serious adverse events.
CONCLUSIONS


Decoglurant was well tolerated overall but did not exert any antidepressant or procognitive effects.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01457677.",2020,Decoglurant exerted no significant effects on Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores or on secondary measures of mood and functioning.,"['patients with partially refractory major depressive disorder (MDD), diagnosed using DSM-IV-TR criteria', 'Individuals with Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 25 and Clinical Global Impressions-Severity of Illness scale score ≥ 4, despite up to 2 adequate trials of an SSRI/SNRI and compliance confirmed by positive SSRI/SNRI blood levels', 'Partially Refractory Major Depressive Disorder', '357 participants']","['placebo', 'Placebo', 'serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs', 'mGlu2/3 Negative Allosteric Modulator Decoglurant']","['Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores', 'MADRS total score or response or remission rates', 'change in MADRS total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.65258,Decoglurant exerted no significant effects on Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores or on secondary measures of mood and functioning.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Umbricht', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Bldg 1/Room 16.N655, Grenzacherstrasse 124, 4070 Basel, Switzerland. daniel.umbricht@roche.com.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Niggli', 'Affiliation': 'Roche Product Development Biometrics, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sanwald-Ducray', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Deptula', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center New York, F. Hoffmann-La Roche Ltd, New York, New York, USA.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Moore', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center New York, F. Hoffmann-La Roche Ltd, New York, New York, USA.'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Grünbauer', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Boak', 'Affiliation': 'Roche Product Development Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Fontoura', 'Affiliation': 'Roche Product Development Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12470']
2728,32663998,Immediate and long-term effectiveness of adding an Internet intervention for depression to routine outpatient psychotherapy: Subgroup analysis of the EVIDENT trial.,"OBJECTIVE


To examine immediate and long-term effectiveness of an adjunctive Internet intervention for depression in a large sample of patients undergoing routine psychotherapy.
METHOD


The current study evaluated a subgroup of patients from the Evident trial, a randomized investigation of a 12-week minimally guided Internet intervention (Deprexis) for the treatment of mild to moderate depression. 340 adults (mean age = 43.3 years; 71.7 % female) of the original sample received routine outpatient psychotherapy during the trial period, resulting in a standard psychotherapy group (n = 174) and an augmented therapy group (n = 166). Outcomes were assessed at baseline, post-treatment and 6-month follow-up.
RESULTS


Intention-to-treat analyses indicated that combined treatment led to a greater reduction in symptoms of depression (effect size d = 0.32; p = .002), improved therapeutic progress (d = 0.36; p = .003), and higher mental health-related quality of life (d = 0.34; p = .004). There was no intervention effect on physical health-related quality of life. The same pattern was found at 6-month follow-up, and adjunctive treatment also resulted in increased rates of clinical improvement. Treatment success was independent from therapeutic orientation of combined face-to-face therapy.
CONCLUSION


Results indicate that the adjunctive use of the investigated intervention can produce additional and lasting effects in routine outpatient psychotherapy for mild to moderate levels of depression. The study adds to the ongoing evidence on augmented effects of blended treatment. Future studies should investigate different types of blends in diverse populations by means of change-sensitive assessment strategies.",2020,"RESULTS


Intention-to-treat analyses indicated that combined treatment led to a greater reduction in symptoms of depression (effect size d = 0.32; p = .002), improved therapeutic progress (","['340 adults (mean age\xa0=\xa043.3 years; 71.7 % female) of the original sample received routine outpatient psychotherapy during the trial period, resulting in a standard psychotherapy group (n\xa0=\xa0174) and an augmented therapy group (n\xa0=\xa0166', 'patients undergoing routine psychotherapy', 'mild to moderate depression']","['Internet intervention', 'adjunctive Internet intervention', 'minimally guided Internet intervention (Deprexis']","['higher mental health-related quality of life', 'symptoms of depression', 'therapeutic progress ', 'physical health-related quality of life', 'rates of clinical improvement']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",340.0,0.0623093,"RESULTS


Intention-to-treat analyses indicated that combined treatment led to a greater reduction in symptoms of depression (effect size d = 0.32; p = .002), improved therapeutic progress (","[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Schuster', 'Affiliation': 'Department of Psychology, University of Salzburg, Austria; Outpatient Center for Clinical Psychology, Psychotherapy and Health Psychology, Department of Psychology, University of Salzburg, Salzburg, Austria. Electronic address: raphael.schuster@sbg.ac.at.'}, {'ForeName': 'Anton-Rupert', 'Initials': 'AR', 'LastName': 'Laireiter', 'Affiliation': 'Department of Psychology, University of Salzburg, Austria; Faculty of Psychology, University of Vienna, Austria; Outpatient Center for Clinical Psychology, Psychotherapy and Health Psychology, Department of Psychology, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Berne, Switzerland.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Research Department, Gaia AG, Hamburg, and Department of Psychology, City, University of London, London, United Kingdom.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Hohagen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.122']
2729,32664000,Depressive symptom severity mediates the association between avoidant problem-solving style and suicidal ideation.,"BACKGROUND


The contemporaneous association between avoidant style, a maladaptive social problem-solving strategy, and adolescent suicidal ideation has been well established. However, the mechanisms underlying this association are not well understood. Using cross-lagged panel modeling, the present study examined whether depressive symptom severity mediates the relation between avoidant style and severity of suicidal ideation. The specificity of depressive symptom severity as a mediator was also evaluated by simultaneously testing whether avoidant style mediates the association between depressive symptom and suicidal ideation severity.
METHODS


The sample included 110 adolescents enrolled in a randomized controlled clinical effectiveness trial. Avoidant style as well as depressive symptom and suicidal ideation severity were assessed via self-report with the Social Problem-Solving Inventory-Revised, Children's Depression Scale-2, and Suicidal Ideation Questionnaire-Junior, respectively, at baseline, 3-and 6-months.
RESULTS


After accounting for participant age, sex, and treatment condition, path analyses supported the specificity of 3-month depressive symptom severity as a mediator of the association between baseline levels of avoidant style and 6-month suicidal ideation severity.
LIMITATIONS


Results may not be generalizable to non-clinical samples. Causality cannot be inferred from study results. Data were exclusively collected via self-report.
CONCLUSIONS


Findings suggest that avoidant style is indirectly related to suicidal ideation through depressive symptom severity. Thus, treatment targeted at improving social problem-solving skills, particularly avoidant style, may help reduce depressive symptoms and lower suicide risk.",2020,"After accounting for participant age, sex, and treatment condition, path analyses supported the specificity of 3-month depressive symptom severity as a mediator of the association between baseline levels of avoidant style and 6-month suicidal ideation severity.
",['110 adolescents enrolled'],[],"[""Social Problem-Solving Inventory-Revised, Children's Depression Scale-2, and Suicidal Ideation Questionnaire-Junior"", 'depressive symptom and suicidal ideation severity', 'avoidant style and 6-month suicidal ideation severity']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0451069', 'cui_str': 'Child depression scale'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",110.0,0.0278102,"After accounting for participant age, sex, and treatment condition, path analyses supported the specificity of 3-month depressive symptom severity as a mediator of the association between baseline levels of avoidant style and 6-month suicidal ideation severity.
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'George Mason University, Department of Psychology. Electronic address: rlopez_jr@post.harvard.edu.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Brick', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Annamarie B', 'Initials': 'AB', 'LastName': 'Defayette', 'Affiliation': 'George Mason University, Department of Psychology.'}, {'ForeName': 'Emma D', 'Initials': 'ED', 'LastName': 'Whitmyre', 'Affiliation': 'George Mason University, Department of Psychology.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wolff', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Frazier', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Christianne', 'Initials': 'C', 'LastName': 'Esposito-Smythers', 'Affiliation': 'George Mason University, Department of Psychology.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.120']
2730,32664003,"Can personalized treatment prediction improve the outcomes, compared with the group average approach, in a randomized trial? Developing and validating a multivariable prediction model in a pragmatic megatrial of acute treatment for major depression.","BACKGROUND


Clinical trials have traditionally been analysed at the aggregate level, assuming that the group average would be applicable to all eligible and similar patients. We re-analyzed a mega-trial of antidepressant therapy for major depression to explore whether a multivariable prediction model may lead to different treatment recommendations for individual participants.
METHODS


The trial compared the second-line treatment strategies of continuing sertraline, combining it with mirtazapine or switching to mirtazapine after initial failure to remit on sertraline among 1,544 patients with major depression. The outcome was the Personal Health Questionnaire-9 (PHQ-9) at week 9: the original analyses showed that both combining and switching resulted in greater reduction in PHQ-9 by 1.0 point than continuing. We considered several models of penalized regression or machine learning.
RESULTS


Models using support vector machines (SVMs) provided the best performance. Using SVMs, continuing sertraline was predicted to be the best treatment for 123 patients, combining for 696 patients, and switching for 725 patients. In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
LIMITATIONS


Stronger predictors are needed to make more precise predictions.
CONCLUSIONS


The multivariable prediction models led to improved recommendations for a minority of participants than the group average approach in a megatrial.",2020,"In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
","['123 patients, combining for 696 patients, and switching for 725 patients', 'individual participants', '1,544 patients with major depression']","['support vector machines (SVMs', 'antidepressant therapy', 'mirtazapine or switching to mirtazapine']","['Personal Health Questionnaire-9 (PHQ-9', 'PHQ-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1544.0,0.0523889,"In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
","[{'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine / School of Public Health, Kyoto, Japan. Electronic address: furukawa@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Thomas P A', 'Initials': 'TPA', 'LastName': 'Debray', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands. Electronic address: T.Debray@umcutrecht.nl.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan. Electronic address: mitsuhiko_yamada@ncnp.go.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic, Nagoya, Japan. Electronic address: aratama8177@yahoo.co.jp.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Seo', 'Affiliation': 'Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland. Electronic address: swj8874@gmail.com.'}, {'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Efthimiou', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Switzerland. Electronic address: oremiou@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.141']
2731,32664033,Expectation-induced placebo effect on acute sadness in women with major depression: An experimental investigation.,"BACKGROUND


Meta-analyses demonstrate that placebo effects play an important role in antidepressant treatment. Expectations seem to constitute a highly relevant placebo mechanism in this context. This study investigated whether an expectation manipulation combined with the intake of an active placebo could reduce acute sadness in depressed participants following a sadness-inducing mood manipulation.
METHODS


Women who suffered from a major depressive episode (N = 94) were randomly allocated to the drug expectation group (expectation to receive a fast-operating antidepressant), the placebo expectation group (expectation to receive a placebo) or the no treatment group (no expectation, no placebo). The drug expectation and the placebo expectation group received a placebo. All participants watched a sadness-inducing film. Sadness was assessed at baseline, after randomization and after placebo intake and mood induction. Data were analyzed by a 3 × 3 analysis of variance.
RESULTS


There were significant between-group differences in sadness change from the baseline after mood induction. While sadness increased in the no treatment group, it did not change in the placebo expectation group. In the drug expectation group, sadness even decreased.
LIMITATIONS


Only a single medication intake was simulated. Effects on acute sadness do not allow inferences about depression symptoms.
CONCLUSION


This experimental study found a placebo effect on sadness in clinically depressed participants. The effects were even larger than expected. Future research must investigate placebo effects on depression symptoms as well as long-term placebo intake.",2020,"While sadness increased in the no treatment group, it did not change in the placebo expectation group.","['clinically depressed participants', 'Women who suffered from a major depressive episode (N\xa0=\xa094', 'depressed participants following a sadness-inducing mood manipulation', 'women with major depression']","['placebo expectation group (expectation to receive a placebo) or the no treatment group (no expectation, no placebo', 'drug expectation group (expectation to receive a fast-operating antidepressant', 'Expectation-induced placebo', 'placebo']","['depression symptoms', 'acute sadness', 'sadness change']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",94.0,0.443496,"While sadness increased in the no treatment group, it did not change in the placebo expectation group.","[{'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Haas', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstr. 18, 35032 Marburg, Germany. Electronic address: julia.wittkowski@uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstr. 18, 35032 Marburg, Germany.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Glombiewski', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Winkler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Doering', 'Affiliation': 'Department of Clinical and Biological Psychology, Catholic University of Eichstätt-Ingolstadt, Eichstätt, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.056']
2732,32664038,Adjunctive intranasal esketamine for major depressive disorder: a systematic review of randomized double-blind controlled-placebo studies - Authors' reply.,,2020,,['major depressive disorder'],"['placebo', 'Adjunctive intranasal esketamine']",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}]",[],,0.658866,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sim', 'Affiliation': 'West Region, Institute of Mental Health, Buangkok Green Medical Park, Buangkok, Singapore.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Ning', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China; The first School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Unit of Psychiatry, Institute of Translational Medicine, Faculty of Health Sciences, University of Macau, Taipa, Macao SAR, China; Center for Cognition and Brain Sciences, University of Macau, Taipa, Macao SAR, China. Electronic address: xyutly@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.154']
2733,32664046,Final results from a randomized phase 3 study of FOLFIRI ± panitumumab for second-line treatment of metastatic colorectal cancer.,,2014,,['metastatic colorectal cancer'],['FOLFIRI ± panitumumab'],[],"[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}]",[],,0.0213531,,[],Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu002']
2734,32672570,Outcomes of the Shunt Tube Exposure Prevention Study: A Randomized Clinical Trial.,"PURPOSE


To compare the long-term safety and efficacy of amniotic membrane-umbilical cord (AM-UC) and pericardium patch grafts in reducing glaucoma shunt tube exposure.
DESIGN


Multicenter, prospective, randomized clinical trial.
PARTICIPANTS


Adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation.
METHODS


Patients were randomized to receive GDD with either AM-UC or pericardium patch grafts to cover GDD tubes. Patients were followed up clinically with anterior segment (AS) OCT to assess patch graft stability and host-tissue integration prospectively.
MAIN OUTCOME MEASURES


Tube exposure, graft thinning, and graft-related complications.
RESULTS


A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n = 72) or Ahmed valve (n = 9). Tubes were inserted in the anterior chamber (n = 71), sulcus (n = 6), or pars plana (n = 4). Tube ligation was performed with Baerveldt GDD along with fenestration (n = 51) or orphan trabeculectomy (n = 21). Tubes were covered with AM-UC (n = 41) or pericardium (n = 40). The mean follow-up time was 29±8 months (range, 13-40 months). Tube exposure occurred in 1 eye (2%) in the AM-UC group at 3 months and in 2 eyes (5%) in the pericardium group at 2 and 6 months (P = 0.54). Sequential AS OCT showed better host-tissue integration and significantly less graft thinning in the AM-UC group. Early graft thinning (≤3 months) occurred in 5 eyes (12%) in the AM-UC group and in 17 eyes (43%) in the pericardium group (P = 0.002). Late thinning occurred in 2 eyes (5%) and 11 eyes (28%) in the AM-UC and pericardium groups, respectively (P = 0.007). Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft. No evidence of graft rejection or infection was associated with the patch grafts in either group.
CONCLUSIONS


Amniotic membrane-umbilical cord grafts are well tolerated and offer an alternative to pericardium for safe and stable tube shunt coverage. Its high-tensile strength, low immunogenicity, and excellent host-tissue integration significantly reduced graft thinning.",2019,Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft.,"['Adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation', 'Patients', 'A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n\xa0= 72) or Ahmed valve (n']","['amniotic membrane-umbilical cord (AM-UC) and pericardium patch grafts', 'AM-UC', 'Tube ligation was performed with Baerveldt GDD along with fenestration (n\xa0= 51) or orphan trabeculectomy', 'GDD with either AM-UC or pericardium patch grafts to cover GDD tubes']","['graft rejection or infection', 'Tube exposure, graft thinning, and graft-related complications', 'graft thinning', 'Tube exposure', 'Early graft thinning', 'host-tissue integration', 'Late thinning', 'Graft translucency and cosmetic appearance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0031050', 'cui_str': 'Pericardial sac structure'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}, {'cui': 'C0242299', 'cui_str': 'Orphan'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",81.0,0.0452362,Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft.,"[{'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Sheha', 'Affiliation': 'Department of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York; Herbert Wertheim College of Medicine, Florida International University, Miami, Florida. Electronic address: hsheha@northwell.edu.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Tello', 'Affiliation': 'Department of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York.'}, {'ForeName': 'Lama A', 'Initials': 'LA', 'LastName': 'Al-Aswad', 'Affiliation': 'Harkness Eye Institute, Columbia University, New York, New York.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Sayed', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: rlee@med.miami.edu.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.08.003']
2735,32672584,"Five-Year, Prospective, Randomized, Multi-Surgeon Trial of Two Trabecular Bypass Stents versus Prostaglandin for Newly Diagnosed Open-Angle Glaucoma.","PURPOSE


To evaluate 5-year safety and efficacy of 2 trabecular micro-bypass stents versus prostaglandin as initial stand-alone treatment for newly diagnosed, treatment-naive primary open-angle glaucoma (POAG).
DESIGN


Prospective, randomized, controlled, multi-surgeon clinical trial.
PARTICIPANTS


Enrolled eyes (n = 101) were phakic and had a confirmed POAG diagnosis, normal angle anatomy, mean diurnal intraocular pressure (IOP) 21 to 40 mmHg, and vertical cup-to-disc (C:D) ratio ≤0.9.
METHODS


Eyes were randomized (1:1) to receive either 2 stents (iStent trabecular micro-bypass; Glaukos Corporation, San Clemente, CA) or once-daily topical travoprost.
MAIN OUTCOME MEASURES


The primary and secondary efficacy end points were the change from screening in mean diurnal IOP at months 12 and 24, respectively, without glaucoma surgery or add-on medication (any medication in stent eyes or a second medication in travoprost eyes). Two additional secondary end points were the proportion of eyes achieving treatment success at months 12 and 24, defined as IOP 6 to 18 mmHg without additional medication or glaucoma surgery. This report shows these efficacy measures through 60 months. Safety measures included best-corrected visual acuity, C:D ratio, visual field, pachymetry, complications, and adverse events.
RESULTS


Of 101 enrolled eyes (54 stent eyes, 47 travoprost eyes), 90 eyes (49 stent eyes, 41 travoprost eyes) completed 5-year follow-up. Five-year mean diurnal IOP was 16.5±1.2 mmHg in stent eyes (35.3% reduced vs. 25.5±2.5 mmHg preoperatively; P < 0.0001) and 16.3±1.9 mmHg in travoprost eyes (35.1% reduced vs. 25.1±4.6 mmHg preoperatively; P < 0.0001). During follow-up, add-on medication was initiated in 12 stent eyes (22.2% of the initial 54-eyes) and 18 travoprost eyes (38.3% of the initial 47-eyes). By 5 years, 17% (6/35) of stent eyes and 44% (14/32) of travoprost eyes needed add-on medication to control IOP (P = 0.017). Treatment success was achieved in 77% (27/35) of stent eyes and 53% (17/32) of travoprost eyes (P = 0.04). Both groups exhibited excellent safety.
CONCLUSIONS


This prospective randomized trial demonstrates 5-year effectiveness and safety of 2 trabecular bypass stents in patients with newly diagnosed, treatment-naive POAG, with comparably favorable outcomes as topical prostaglandin.",2019,Treatment success was achieved in 77% (27/35) of stent eyes and 53% (17/32) of travoprost eyes (P = 0.04).,"['Enrolled eyes (n\xa0= 101) were phakic and had a confirmed POAG diagnosis, normal angle anatomy, mean diurnal intraocular pressure (IOP', 'patients with newly diagnosed, treatment-naive POAG', '101 enrolled eyes (54 stent eyes, 47 travoprost eyes), 90 eyes (49 stent eyes, 41 travoprost eyes) completed 5-year follow-up', 'newly diagnosed, treatment-naive primary open-angle glaucoma (POAG', 'Eyes', 'Newly Diagnosed Open-Angle Glaucoma']","['2 stents (iStent trabecular micro-bypass; Glaukos Corporation, San Clemente, CA) or once-daily topical travoprost', '2 trabecular micro-bypass stents versus prostaglandin', 'topical prostaglandin', '2 trabecular bypass stents', 'Two Trabecular Bypass Stents versus Prostaglandin']","['mean diurnal IOP', 'proportion of eyes achieving treatment success', 'corrected visual acuity, C:D ratio, visual field, pachymetry, complications, and adverse events', 'diurnal IOP', 'Treatment success', '5-year effectiveness and safety', '5-year safety and efficacy']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0937916', 'cui_str': 'travoprost'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0937916', 'cui_str': 'travoprost'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",101.0,0.109036,Treatment success was achieved in 77% (27/35) of stent eyes and 53% (17/32) of travoprost eyes (P = 0.04).,"[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Fechtner', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, New York. Electronic address: fechtner@upstate.edu.'}, {'ForeName': 'Lilit', 'Initials': 'L', 'LastName': 'Voskanyan', 'Affiliation': 'S.V. Malayan Ophthalmology Center, Yerevan, Armenia.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Vold', 'Affiliation': 'Vold Vision, PLLC, Fayetteville, Arkansas.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Tetz', 'Affiliation': 'Berlin Eye Research Institute and Augenklinik Spreebogen, Berlin, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Auffarth', 'Affiliation': 'Department of Ophthalmology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Masood', 'Affiliation': 'Birmingham City Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Au', 'Affiliation': 'Manchester Royal Eye Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Albert S', 'Initials': 'AS', 'LastName': 'Khouri', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Iqbal Ike K', 'Initials': 'IIK', 'LastName': 'Ahmed', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'Saheb', 'Affiliation': 'Mcgill University, Montreal, Quebec, Canada.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.03.004']
2736,32672594,Outflow Facility Effects of 3 Schlemm's Canal Microinvasive Glaucoma Surgery Devices.,"PURPOSE


To study the effect of 3 Schlemm's canal (SC) microinvasive glaucoma surgery (MIGS) devices on outflow facility.
DESIGN


Paired comparisons, randomized design, baseline-controlled study.
PARTICIPANTS


Thirty-six pairs of dissected anterior segments from donated human eye bank eyes without glaucoma were studied. A baseline measurement was collected from each eye to serve as its control.
METHODS


Using a constant pressure perfusion method, outflow facility was measured in paired eyes from human donors. Measurements were made at perfusion pressures of 10 mmHg, 20 mmHg, 30 mmHg, and 40 mmHg. Outflow facility was measured before (baseline control) and after the implantation of an SC glaucoma drainage device or sham procedure. Three sets of experiments were carried out comparing 1 and 2 iStent Trabecular Micro-Bypass Stents and 2 iStent Inject implants with the Hydrus Microstent.
MAIN OUTCOME MEASURES


Change in outflow facility from baseline or contralateral eye.
RESULTS


After Hydrus placement, the outflow facility increased from 0.23±0.03 μl/minute per millimeter of mercury at baseline to 0.38±0.03 μl/minute per millimeter of mercury (P < 0.001). The percent increase in outflow facility was 79±21% for the Hydrus and 11±16% for the 2 iStent Inject devices, a difference that was significant (P = 0.018). Outflow facility with 1 iStent (0.38±0.07 μl/minute per millimeter of mercury) was greater than baseline (0.28±0.03 μl/minute per millimeter of mercury; P = 0.031). The 1 iStent showed a greater increase in outflow facility from baseline (0.10±0.04 μl/minute per millimeter of mercury) compared with the sham procedure (-0.08±0.05 μl/minute per millimeter of mercury; P = 0.042). No other significant differences were found.
CONCLUSIONS


The longer the MIGS device, and thus the more SC that it dilates, the greater the outflow facility.",2020,"After Hydrus placement, the outflow facility increased from 0.23±0.03 μl/minute per millimeter of mercury at baseline to 0.38±0.03 μl/minute per millimeter of mercury (P < 0.001).","[""3 Schlemm's Canal Microinvasive Glaucoma Surgery Devices"", 'paired eyes from human donors', 'Thirty-six pairs of dissected anterior segments from donated human eye bank eyes without glaucoma were studied']","[""3 Schlemm's canal (SC) microinvasive glaucoma surgery (MIGS"", 'iStent Trabecular Micro-Bypass Stents and 2 iStent Inject implants with the Hydrus Microstent']","['Change in outflow facility from baseline or contralateral eye', 'Outflow facility', 'outflow facility', 'minute per millimeter of mercury']","[{'cui': 'C0229108', 'cui_str': 'Structure of sinus venosus of sclera'}, {'cui': 'C0205622', 'cui_str': 'Microinvasive tumor'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0015394', 'cui_str': 'Eye Banks'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0229108', 'cui_str': 'Structure of sinus venosus of sclera'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205622', 'cui_str': 'Microinvasive tumor'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]",,0.139625,"After Hydrus placement, the outflow facility increased from 0.23±0.03 μl/minute per millimeter of mercury at baseline to 0.38±0.03 μl/minute per millimeter of mercury (P < 0.001).","[{'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Toris', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio; Department of Ophthalmology and Visual Sciences, University of Nebraska Medical Center, Omaha, Nebraska. Electronic address: ctoris@unmc.edu.'}, {'ForeName': 'Padmanabhan P', 'Initials': 'PP', 'LastName': 'Pattabiraman', 'Affiliation': 'Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tye', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Samuelson', 'Affiliation': 'Minnesota Eye Consultants, Minneapolis, Minnesota; Department of Ophthalmology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rhee', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.11.013']
2737,32672612,"Safety and Efficacy of 0.1% Nepafenac versus 1% Prednisolone Acetate Eye Drops after Laser Peripheral Iridotomy: A Prospective, Randomized Trial.","PURPOSE


To compare 0.1% nepafenac, a topical nonsteroidal anti-inflammatory drop, with 1% prednisolone acetate in controlling inflammation after neodymium:yttrium-aluminum-garnet laser peripheral iridotomy (LPI) in primary angle-closure suspects (PACS).
DESIGN


Randomized controlled trial.
PARTICIPANTS


One hundred fifty-two PACS undergoing bilateral LPI.
METHODS


Patients were randomized to 0.1% nepafenac or 1% prednisolone acetate eye drops in both eyes. Medications were given 4 times daily for 7 days, then twice daily for additional 7 days. Investigators were masked to the type of medication. Right eyes in patients with bilateral PACS and the PACS eye in asymmetrical disease (primary angle closure in fellow eye) were analyzed.
MAIN OUTCOME MEASURES


Noninferior control of inflammation, defined as absence of cell in the anterior chamber at 2 weeks and absence of rebound iritis with medication discontinuation, was the primary outcome, whereas difference in the rise in intraocular pressure (IOP) was a secondary outcome.
RESULTS


Both groups were comparable in baseline characteristics, including IOP and total laser energy. Nepafenac was noninferior to prednisolone with regard to inflammation control, with 1 nepafenac-treated eye (1.3%) not meeting the primary end point because of 1+ anterior chamber cell at 2 weeks and 4 prednisolone-treated eyes (5.4%) failing to meet the primary end point because of rebound iritis (P < 0.001). A greater increase in IOP from baseline to 2 weeks was observed in the prednisolone group compared with the nepafenac group (+2.6 mmHg vs. +0.6 mmHg; P = 0.004), although at 4 weeks, IOP was not significantly different than baseline in either group (P > 0.05 for both). Two weeks after LPI, 3 nepafenac-treated eyes and 10 prednisolone-treated eyes demonstrated a 6- to 15-mmHg IOP elevation from baseline (P = 0.10), whereas 2 prednisolone-treated eyes and no nepafenac-treated eyes showed IOP elevation of more than 15 mmHg (P = 0.20). Four weeks after LPI, more prednisolone-treated eyes showed IOP elevation of 6 to 15 mmHg as compared with nepafenac-treated eyes (6 eyes vs. 1 eye; P = 0.04); no eyes showed IOP elevation of more than 15 mmHg.
CONCLUSIONS


Nepafenac was noninferior to prednisolone in controlling inflammation after LPI in PACS.",2020,"A greater increase in IOP from baseline to 2 weeks was observed in the prednisolone group compared with the nepafenac group (+2.6 mmHg vs. +0.6 mmHg; P = 0.004), although at 4 weeks, IOP was not significantly different than baseline in either group (P > 0.05 for both).","['One hundred fifty-two PACS undergoing bilateral LPI', 'primary angle-closure suspects (PACS', 'after Laser Peripheral Iridotomy', 'Patients', 'patients with bilateral PACS and the PACS eye in asymmetrical disease (primary angle closure in fellow eye']","['Prednisolone Acetate Eye Drops', 'prednisolone acetate', 'nepafenac', 'prednisolone', 'prednisolone-treated eyes and no nepafenac', 'nepafenac or 1% prednisolone acetate eye drops', 'Nepafenac', 'neodymium:yttrium-aluminum-garnet laser peripheral iridotomy (LPI']","['rebound iritis', 'Safety and Efficacy', 'absence of cell in the anterior chamber at 2 weeks and absence of rebound iritis with medication discontinuation', 'IOP elevation', 'IOP and total laser energy', 'IOP', 'intraocular pressure (IOP']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0197497', 'cui_str': 'Anterior segment of eye incision'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}]","[{'cui': 'C0022081', 'cui_str': 'Iritis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]",152.0,0.244206,"A greater increase in IOP from baseline to 2 weeks was observed in the prednisolone group compared with the nepafenac group (+2.6 mmHg vs. +0.6 mmHg; P = 0.004), although at 4 weeks, IOP was not significantly different than baseline in either group (P > 0.05 for both).","[{'ForeName': 'Keerthi', 'Initials': 'K', 'LastName': 'Gayam', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins University, Baltimore, Maryland; Glaucoma Department, Wilmer Eye Institute, John Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Rengaraj', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India. Electronic address: skavitha.shree@gmail.com.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.02.006']
2738,32672665,The effectiveness of pure Stichopus horrens extract toothpaste in reducing plaque-induced gingivitis following orthodontic bonding: A triple-blinded randomized controlled trial.,"INTRODUCTION


Gingivitis is one of the commonest problems faced by patients with fixed appliances (FA) as there is close relation between the appliances to gingival sulcus. Stichopus horrens (SH) is a sea cucumber from the Indo-Pacific that has medical healing properties which have been traditionally used.
OBJECTIVE


To assess the effects of toothpaste containing aqueous SH extract on plaque-induced gingivitis following orthodontic bond-up and to identify the optimal concentration of SH.
METHODS


A single-centred; triple-blinded randomized controlled trial conducted in 40 patients with FA. Participants were randomly assigned to one of the four groups with toothpaste which has concentration of SH extract of 0%, 3%, 6% or 9%. The statistician, the participants and the researchers involved in data collection were kept blinded from the allocation. Gingival Index (GI) and Bleeding on Probing (BOP) for each group were taken at day 0,7,14 and 30.
RESULTS


9% of SH-containing toothpaste (SHCT) showed most substantial result as there were significance difference of GI (P = 0.020) from Day 7 to 14 and from Day 0 to 14 (P = 0.020). There was also significance difference of BOP from Day 0 to 14 (P = 0.022) and from Day 0 to 30 (P = 0.027). Significant difference was seen in 3% of SHCT group with the decrease of GI (P = 0.004) from Day 1 to 14. There were no significant difference noted for 0% and 6% SHCT.
CONCLUSION


The 9% SHCT is the most effective concentration to reduce both the gingival inflammation (up to day 14) and bleeding on probing (up to day 30).",2020,Significant difference was seen in 3% of SHCT group with the decrease of GI (P = 0.004) from Day 1 to 14.,"['plaque-induced gingivitis following orthodontic bonding', 'patients with fixed appliances (FA', '40 patients with FA']","['toothpaste containing aqueous SH extract', 'pure Stichopus horrens extract toothpaste', 'Stichopus horrens (SH', 'SH-containing toothpaste (SHCT', 'SH', 'SHCT', 'toothpaste']","['gingival inflammation', 'BOP', 'plaque-induced gingivitis', 'Gingival Index (GI) and Bleeding on Probing (BOP', 'concentration of SH extract']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0998720', 'cui_str': 'Stichopus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0998720', 'cui_str': 'Stichopus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",40.0,0.0951074,Significant difference was seen in 3% of SHCT group with the decrease of GI (P = 0.004) from Day 1 to 14.,"[{'ForeName': 'Noraini Abu', 'Initials': 'NA', 'LastName': 'Bakar', 'Affiliation': 'Department of Orthodontics, International Islamic University Malaysia, Kulliyyah of Dentistry, Kuantan, Pahang, Malaysia. Electronic address: nor_aini@iium.edu.my.'}, {'ForeName': 'Nurul Idayu', 'Initials': 'NI', 'LastName': 'Jayah', 'Affiliation': 'International Islamic University Malaysia, Kulliyyah of Dentistry, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Nurul Rafhana', 'Initials': 'NR', 'LastName': 'Mohamed', 'Affiliation': 'International Islamic University Malaysia, Kulliyyah of Dentistry, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Suhaila Muhammad', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Periodontics, International Islamic University Malaysia, Kulliyyah of Dentistry, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Siti Hajjar', 'Initials': 'SH', 'LastName': 'Nasir', 'Affiliation': 'Department of Orthodontics, International Islamic University Malaysia, Kulliyyah of Dentistry, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Ridzwan', 'Initials': 'R', 'LastName': 'Hashim', 'Affiliation': 'International Islamic University Malaysia, Kulliyyah of Allied Health Science, Kuantan, Pahang, Malaysia.'}, {'ForeName': 'Azrul Fazwan', 'Initials': 'AF', 'LastName': 'Kharuddin', 'Affiliation': 'Statistician, International Islamic University Malaysia, Kulliyyah of Science, Kuantan, Pahang, Malaysia.'}]",Journal of the World federation of orthodontists,['10.1016/j.ejwf.2019.11.004']
2739,32672669,Once-Daily Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure in the Randomized Phase 3 MERCURY-2 Study.,"PURPOSE


To compare the ocular hypotensive efficacy and safety of a once-daily (pm) fixed-dose combination (FDC) product containing netarsudil 0.02% and latanoprost 0.005% with monotherapy with netarsudil or latanoprost. Netarsudil is a Rho kinase inhibitor that lowers intraocular pressure (IOP) primarily by increasing trabecular (conventional) outflow. Latanoprost is the most frequently prescribed of the prostaglandin analogs, which lower IOP primarily by increasing uveoscleral outflow.
DESIGN


Three-month, double-masked, randomized (1:1:1), phase 3, superiority study.
PARTICIPANTS


Patients had unmedicated IOP > 20 to <36 mmHg at 8:00 am and met other standard criteria for open-angle glaucoma and ocular hypertension.
METHODS


Randomization to once-daily (pm) netarsudil/latanoprost FDC, netarsudil, or latanoprost for 3 months.
MAIN OUTCOME MEASURES


Mean IOP at 8:00 am, 10:00 am, and 4:00 pm at week 2, week 6, and month 3 (intent-to-treat). Statistical superiority was concluded if the P value for the comparison of netarsudil/latanoprost FDC with each component was <0.05 and the difference in mean IOP (netarsudil/latanoprost FDC minus comparator) was <0 for all time points at all visits. Safety was recorded throughout the treatment period.
RESULTS


A total of 750 patients were enrolled, with 90.2%, 89.4%, and 94.4% completing 3 months of treatment with netarsudil/latanoprost FDC, netarsudil, and latanoprost, respectively. Least-squares mean treated IOP ranged from 15.3 to 16.5 mmHg for netarsudil/latanoprost FDC, 17.4 to 19.8 mmHg for netarsudil, and 17.1 to 18.1 mmHg for latanoprost. Netarsudil/latanoprost FDC met the criteria for superiority to each active component at all 9 time points (all P < 0.0001), lowering IOP by an additional 2.2 to 3.3 mmHg versus netarsudil and an additional 1.5 to 2.4 mmHg versus latanoprost. At month 3, the proportion of patients achieving mean diurnal IOP ≤ 15 mmHg was 42.1% for netarsudil/latanoprost FDC, 15.8% for netarsudil, and 18.3% for latanoprost. No treatment-related serious adverse event (AE) was observed. Treatment-related systemic AEs were minimal. The most frequent ocular AE was conjunctival hyperemia (netarsudil/latanoprost FDC, 54.5%; netarsudil, 42.7%; latanoprost, 22.3%), which was generally mild.
CONCLUSIONS


Once-daily netarsudil/latanoprost FDC demonstrated IOP reductions that were statistically and clinically superior to its individual components at all 9 time points over 3 months, with tolerable ocular safety. This FDC offers a reduced treatment burden that may improve adherence and clinical outcomes.",2019,"FDC demonstrated IOP reductions that were statistically and clinically superior to its individual components at all 9 time points over 3 months, with tolerable ocular safety.","['Patients had unmedicated IOP > 20 to <36 mmHg at 8:00 am and met other standard criteria for open-angle glaucoma and ocular hypertension', 'A total of 750 patients were enrolled, with 90.2%, 89.4%, and 94.4% completing 3 months of treatment with netarsudil/latanoprost FDC, netarsudil, and latanoprost, respectively']","['once-daily (pm) fixed-dose combination (FDC) product containing netarsudil 0.02% and latanoprost', 'Latanoprost Fixed-Dose Combination', 'Latanoprost', 'daily (pm) netarsudil/latanoprost FDC, netarsudil, or latanoprost', 'monotherapy with netarsudil or latanoprost', 'latanoprost']","['Safety', 'Mean IOP', 'serious adverse event (AE', 'proportion of patients achieving mean diurnal IOP', 'lowering IOP', 'ocular hypotensive efficacy and safety', 'mean IOP', 'conjunctival hyperemia', 'IOP reductions', 'intraocular pressure (IOP']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0028841', 'cui_str': 'Hypotony of eye'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",750.0,0.0972581,"FDC demonstrated IOP reductions that were statistically and clinically superior to its individual components at all 9 time points over 3 months, with tolerable ocular safety.","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Walters', 'Affiliation': 'Texan Eye PA, Austin, Texas. Electronic address: tom@nobhill.me.'}, {'ForeName': 'Iqbal Ike K', 'Initials': 'IIK', 'LastName': 'Ahmed', 'Affiliation': 'University of Toronto, Mississauga, Ontario, Canada.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, California; Bedminster, New Jersey; and Durham, North Carolina; Sacramento Eye Consultants, Sacramento, California.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Usner', 'Affiliation': 'Statistics & Data Corporation, Tempe, Arizona.'}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Lopez', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, California; Bedminster, New Jersey; and Durham, North Carolina.'}, {'ForeName': 'Casey C', 'Initials': 'CC', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, California; Bedminster, New Jersey; and Durham, North Carolina.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, California; Bedminster, New Jersey; and Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.03.007']
2740,32664074,Promoting breastfeeding in Chinese women undergoing cesarean section based on the health belief model: A randomized controlled trial.,"BACKGROUND


The high rate of cesarean section is an important factor affecting breastfeeding in China. To improve the nation's current situation of breastfeeding, promoting breastfeeding in women undergoing cesarean section is essential.
OBJECTIVE


To explore the effects of health belief model-based interventions on breastfeeding knowledge, breastfeeding behaviors, and breastfeeding satisfaction of Chinese cesarean women.
METHODS


A total of 346 cesarean section women were enrolled in the randomized controlled trial conducted at a center in Chengdu, China, between July 1, 2018 and August 31, 2018. While the control group (n = 173) received conventional breastfeeding guidance only, the intervention group (n = 173) received additional interventions based on the health belief model. Questionnaires were distributed to assess breastfeeding knowledge, breastfeeding behavior, and breastfeeding satisfaction at discharge, 42 days postpartum, and 4 months postpartum, respectively.
RESULTS


At discharge from hospital, the breastfeeding knowledge score of the intervention group was higher than that of the control group (Z = -11.753, P < .001). The exclusive breastfeeding rates in the intervention group at the time of discharge, 42 days postpartum, and 4 months postpartum were 67.3%, 60.7%, and 52.9%, respectively, while those of the control group were 41.2%, 41.6%, and 40.4%, respectively. The differences were statistically significant (χ = 23.353, P < .001; χ = 11.853, P < .001; χ = 4.805, P = .03). The breastfeeding satisfaction of the intervention group was also higher than the control group at the time of discharge, 42 days postpartum and 4 months postpartum (t = 4.955, P < .001; t = 3.051, P = .002; Z = -3.801, P < .001).
CONCLUSION


The health belief model-based interventions can effectively increase breastfeeding knowledge for Chinese cesarean women and improve their breastfeeding behaviors and breastfeeding satisfaction within 4 months after delivery.
CLINICAL TRIAL REGISTRATION


ChiCTR1900026006 <http://www.chictr.org.cn/usercenter.aspx>.",2020,"The breastfeeding satisfaction of the intervention group was also higher than the control group at the time of discharge, 42 days postpartum and 4 months postpartum (","['A total of 346 cesarean section women were enrolled in the randomized controlled trial conducted at a center in Chengdu, China, between July 1, 2018 and August 31, 2018', 'Chinese women undergoing cesarean section based on the health belief model', 'women undergoing cesarean section', 'Chinese cesarean women']","['health belief model-based interventions', 'additional interventions based on the health belief model', 'conventional breastfeeding guidance']","['breastfeeding satisfaction', 'breastfeeding knowledge score', 'breastfeeding behaviors and breastfeeding satisfaction', 'breastfeeding knowledge, breastfeeding behavior, and breastfeeding satisfaction', 'breastfeeding knowledge', 'exclusive breastfeeding rates', 'breastfeeding knowledge, breastfeeding behaviors, and breastfeeding satisfaction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0517671', 'cui_str': 'Knowledge level: breastfeeding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319304', 'cui_str': 'Breastfeeding performance'}]",346.0,0.0719075,"The breastfeeding satisfaction of the intervention group was also higher than the control group at the time of discharge, 42 days postpartum and 4 months postpartum (","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Nursing, West China Second University Hospital, Sichuan University.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Ding', 'Affiliation': ""Department of Intensive Care Unit, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Nursing, West China Second University Hospital, Sichuan University.'}, {'ForeName': 'Biru', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Department of Nursing, West China Second University Hospital, Sichuan University.'}]",Medicine,['10.1097/MD.0000000000020815']
2741,32664084,"A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of HT083 on mild osteoarthritis.","BACKGROUND


The increasing prevalence of osteoarthritis among the old population worldwide is a great concern. Two of the biggest complaints of OA patients are joint pain and inflammation. Currently, people are relying on non-steroidal anti-inflammatory drugs (NSAIDs) and steroids to control pain and inflammation. However, long-term use of these pharmaceutical drugs has negative health consequences in the elderly, including gastro-intestinal, respiratory, and renal diseases. Natural products are receiving more attention than ever as alternative treatments against OA for their efficacies and safety. The root of Paeonia lactiflora Pal and the gum resin of Commiphora myrrha have been used as analgesics and anti-inflammatory agents since ancient time. A new herbal formula composed of P. lactiflora root and C. myrrha gum resin extracts, known as HT083, has shown promising antinociceptive and anti-inflammatory effects in a rodent model of OA. We design this study to investigate the safety and the efficacy of HT083 to prevent OA in patients with mild OA.
METHODS


This is a randomized, double-blind, and placebo-controlled study. A total of 100 eligible participants will be divided into two groups and will be given HT083 and a placebo for 12 weeks in 1:1 ratio. Treatment results will be assessed using a visual analog scale (VAS), Korean-Short Form health survey-36 score (SF-36), personal evaluation, and laboratory analysis.
DISCUSSION


This trial is expected to provide clinical evidence on the effectiveness and the safety of HT083 as a natural treatment for mild OA.
TRIAL REGISTRATION


Korean Clinical Research Information Service (CRIS) number KCT0004925 Registered on 2020.04.16.",2020,"A new herbal formula composed of P. lactiflora root and C. myrrha gum resin extracts, known as HT083, has shown promising antinociceptive and anti-inflammatory effects in a rodent model of OA.","['100 eligible participants', 'patients with mild OA', 'mild OA']",['placebo'],"['visual analog scale (VAS), Korean-Short Form health survey-36 score (SF-36), personal evaluation, and laboratory analysis', 'mild osteoarthritis', 'joint pain and inflammation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",100.0,0.275995,"A new herbal formula composed of P. lactiflora root and C. myrrha gum resin extracts, known as HT083, has shown promising antinociceptive and anti-inflammatory effects in a rodent model of OA.","[{'ForeName': 'Donghun', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Herbal Pharmacology, College of Korean Medicine, Gachon University, Seongnam.'}, {'ForeName': 'Seok Jung', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'Hocheol', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Herbal Pharmacology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000020907']
2742,32664090,The myocardial protective effect of monosodium phosphate cardioplegia in cardiopulmonary bypass in infants with an atrial septal defect.,"This study aimed to investigate the myocardial protective effect of liquid sodium phosphocreatine cardiac arrest in extracorporeal circulation surgery treating infants with atrial septal defects.Eighty-four infants with atrial septal defects who required extracorporeal circulation surgery treatment at our hospital from January 2016 to June 2018 were divided into an observation group and a control group through a digitally randomized method, with 42 cases in each group. The control group adopted the conventional modified St Thomas II high potassium cold liquid crystal cardiac arrest, while the observation group adopted the liquid sodium phosphocreatine cardiac arrest.The myocardial enzyme indexes of the 2 groups 3, 6, 12, and 24 hours postoperatively were higher than before establishing the cardiopulmonary bypass and the enzyme indexes of the control group at the same time were higher than that of the observation group; adenosine triphosphate, adenosine diphosphate, and other energy levels and the postoperative recovery rate energy levels of the observation group were higher than those in the control group, the difference was statistically significant (P < .05).Liquid sodium phosphocreatine cardiac arrest used in extracorporeal circulation surgery treating infants with atrial septal defects can reduce myocardial ischemia-reperfusion injury, maintain energy supply during ischemia, strengthen the St Thomas II effect, and aid postoperative cardiac function recovery of high potassium cold liquid crystal cardiac arrest used in infants with atrial septal defects and treated with extracorporeal circulation surgery.",2020,"The myocardial enzyme indexes of the 2 groups 3, 6, 12, and 24 hours postoperatively were higher than before establishing the cardiopulmonary bypass and the enzyme indexes of the control group at the same time were higher than that of the observation group; adenosine triphosphate, adenosine diphosphate, and other energy levels and the postoperative recovery rate energy levels of the observation group were higher than those in the control group, the difference was statistically significant (P < .05).Liquid","['infants with an atrial septal defect', 'extracorporeal circulation surgery treating infants with atrial septal defects', 'Eighty-four infants with atrial septal defects who required extracorporeal circulation surgery treatment at our hospital from January 2016 to June 2018', 'infants with atrial septal defects']","['extracorporeal circulation surgery', 'monosodium phosphate cardioplegia', 'liquid sodium phosphocreatine cardiac arrest']","['myocardial enzyme indexes', 'adenosine triphosphate, adenosine diphosphate, and other energy levels and the postoperative recovery rate energy levels', 'myocardial protective effect']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0031634', 'cui_str': 'fosfocreatine'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0127664,"The myocardial enzyme indexes of the 2 groups 3, 6, 12, and 24 hours postoperatively were higher than before establishing the cardiopulmonary bypass and the enzyme indexes of the control group at the same time were higher than that of the observation group; adenosine triphosphate, adenosine diphosphate, and other energy levels and the postoperative recovery rate energy levels of the observation group were higher than those in the control group, the difference was statistically significant (P < .05).Liquid","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhai', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020934']
2743,32664094,Effect of phenylephrine infusion on hypotension induced by the beach chair position: A prospective randomized trial.,"BACKGROUND


The beach chair position (BCP), used during shoulder surgery, is associated with hypotension, bradycardia, and risk of cerebral hypoperfusion. Phenylephrine is commonly used as a first treatment of choice of intraoperative hypotension during surgery. We evaluated the hemodynamic effects of 2 doses of intravenous phenylephrine infusion administered before being placed in BCP for arthroscopic shoulder surgery. The primary endpoint was the incidence of hypotension after positional change.
METHODS


Sixty-six patients were randomized to receive either intravenous normal saline (group NS) or intravenous phenylephrine infusion (0.5 μg/kg/min, group LP or 1.0 μg/kg/min, group HP) for 5 minutes before being placed in the BCP. Mean arterial pressure(MAP), heart rate, stroke volume variation, and cardiac index were measured before and after positional change.
RESULTS


The total incidence of hypotension after the BCP was 93.65%, but was not significantly different among the 3 groups. However, there was a significant difference in trends between the groups for MAP for 5 minutes after BCP (P = .028). Comparison of changes in MAP at 1 minute compared to post-induction MAP was significantly different between group HP and group NS (P = .014).
CONCLUSION


Infusion of 0.5 and 1.0 μg/kg/min of phenylephrine for 5 minutes before the BCP has no preventive effect for incidence of hypotension. However, this study showed that 1.0 μg/kg/min of phenylephrine infusion for 5 minutes can attenuate the severity of hypotension.",2020,"Comparison of changes in MAP at 1 minute compared to post-induction MAP was significantly different between group HP and group NS (P = .014).
","['Sixty-six patients', 'arthroscopic shoulder surgery']","['phenylephrine', 'phenylephrine infusion', 'intravenous normal saline', 'Phenylephrine', 'intravenous phenylephrine infusion']","['Mean arterial pressure(MAP), heart rate, stroke volume variation, and cardiac index', 'incidence of hypotension after positional change', 'total incidence of hypotension', 'hemodynamic effects', 'hypotension', 'severity of hypotension']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",66.0,0.324466,"Comparison of changes in MAP at 1 minute compared to post-induction MAP was significantly different between group HP and group NS (P = .014).
","[{'ForeName': 'Myoung Jin', 'Initials': 'MJ', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Hyojoong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Hyun-Seong', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Soo Jee', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Yei Heum', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Jin-Young', 'Initials': 'JY', 'LastName': 'Bang', 'Affiliation': 'Department of Orthopedic Surgery, Haeundae Paik Hospital of Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Ki Hwa', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}]",Medicine,['10.1097/MD.0000000000020946']
2744,32664101,Randomized trial protocol of interscalene nerve block vs liposomal bupivacaine injection after total shoulder arthroplasty.,"BACKGROUND


The possibility of local infiltration analgesia (LIA) replacing interscalene blockade (ISB) as an integral component of a multimodal clinical pathway for total shoulder arthroplasty (TSA) needs to be further investigated. We thus further designed a randomized controlled study to compare LIA with ISB in the treatment of TSA.
METHODS


This blinded and randomised study was performed after approval of the institutional review board in the first affiliated hospital of Jinan University. The included patients were all aged over 18 years and underwent shoulder arthroplasty because of osteoarthritis of the shoulder. Subjects were randomized into 2 groups as follows: LIA or ISB. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. Secondary outcomes included pain scores, length of hospital stay, complication, and satisfaction score. P value < .05 was considered statistically significant.
RESULTS


For the present trial, we hypothesized that there would be no difference in pain score levels and opioid medication use throughout admission.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5640).",2020,"For the present trial, we hypothesized that there would be no difference in pain score levels and opioid medication use throughout admission.
","['total shoulder arthroplasty (TSA', 'The included patients were all aged over 18 years and underwent shoulder arthroplasty because of osteoarthritis of the shoulder', 'institutional review board in the first affiliated hospital of Jinan University', 'total shoulder arthroplasty']","['local infiltration analgesia (LIA) replacing interscalene blockade (ISB', 'LIA with ISB', 'LIA or ISB', 'interscalene nerve block vs liposomal bupivacaine injection']","['opioid consumption within the first 24\u200ahours following surgery', 'pain scores, length of hospital stay, complication, and satisfaction score', 'pain score levels']","[{'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0409939', 'cui_str': 'Osteoarthritis of glenohumeral joint'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C4060211', 'cui_str': 'Bupivacaine Injection [Sensorcaine]'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.275289,"For the present trial, we hypothesized that there would be no difference in pain score levels and opioid medication use throughout admission.
","[{'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology, The Second Clinical Medical College, Jinan University/Shenzhen People's Hospital.""}, {'ForeName': 'Yalan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The first affiliated hospital of Jinan University, Guangdong Province, China.'}]",Medicine,['10.1097/MD.0000000000020968']
2745,32664105,Feasibility of customizing titanium implant with three-dimensional CT imaging of low dose in skull.,"OBJECT


To explore the feasibility and practicability of making virtual three-dimensional model of skull defect and customizing titanium implant by skull three-dimensional CT examination of low dose.
METHODS


Sixty patients with skull defects who underwent skull three-dimensional CT before cranioplasty were randomly divided into 4 groups: group A (conventional dose 120 peak Kilovoltage (kVp), 150 tube current time product (mAs)), low dose group B (120 kVp, 50 mAs), low dose group C (100 kVp, 50 mAs), low dose group D (100 kVp, 30 mAs). After the scanning, we compared radiation doses and image quality among the groups. The CT data were sent to the reconstruction company to produce accurate titanium implants, and neurosurgeons performed cranioplasty. After the operation, patients immediately underwent head CT scans to confirm the accuracy of the implantation position, and a series of clinical functions were evaluated.
RESULTS


There were significant differences in dose length product (DLP) and effective dose (ED) among the 4 groups (P < .001). The volume CT dose index (CDTIvol), DLP, and ED in group D were, respectively, 87.1%, 86.9%, and 87.3% lower than those in group A (P < .001). All images quality were at or above the general level, and there was no statistical difference (P > .05). Titanium implants were successfully manufactured, every cranioplasty was carried out smoothly, and the clinical function of patients recovered well.
CONCLUSION


Customizing titanium implant with three-dimensional CT imaging of low dose in skull not only met the clinical requirements, but also significantly reduced the radiation dose and hazard.",2020,"All images quality were at or above the general level, and there was no statistical difference (P > .05).",['Sixty patients with skull defects who underwent skull three-dimensional CT before cranioplasty'],"['customizing titanium implant', 'group A (conventional dose 120 peak Kilovoltage (kVp), 150 tube current time product (mAs', 'head CT scans']","['volume CT dose index (CDTIvol), DLP, and ED', 'dose length product (DLP) and effective dose (ED']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0196112', 'cui_str': 'Cranioplasty'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0202691', 'cui_str': 'CT of head'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0148684,"All images quality were at or above the general level, and there was no statistical difference (P > .05).","[{'ForeName': 'Min-Xia', 'Initials': 'MX', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University, Shaoxing, Zhejiang Province, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Zhao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021009']
2746,32664127,Novel airway device Vie Scope in several pediatric airway scenario: A randomized simulation pilot trial.,"CONTEXT


Endotracheal intubation of pediatric patients is challenging, especially in the pre-hospital emergency setting and if performed by less experienced providers. Securing an airway should be achieved with a single intubation attempt, as each intubation attempt contributes to morbidity and mortality. A new airway device, the VieScope, was recently introduced into clinical market, but efficacy to reduced intubation attempts remains unclear thus far.
OBJECTIVE


We aimed to compare endotracheal intubation by paramedics using the Vie Scope in different pediatric airway simulation conditions.
METHODS


We conducted a randomized, cross-over simulation study. Following a theoretical and practical training session, paramedics performed endotracheal intubation in 3 different pediatric emergency scenarios: normal airway; tongue edema; cardiopulmonary resuscitation using the VieScope. Overall intubation success rate was the primary outcome. Secondary outcomes included number of intubation attempts, time to intubation, Cormack-Lehane grade, POGO score, and ease of use (using 1-100 scale).
RESULTS


Fifty-five paramedics with at least 2 years of clinical experience and without any previous experience with the VieScope participated in this study. The overall intubation success rate was 100% in all 3 scenarios. The median intubation time was 27 (24-34) versus 27 (25-37) versus 29 (25-40) s for scenarios A, B, and C, respectively. In scenario A, all paramedics performed successful intubation with 1 single intubation attempt, whereas 2% of the paramedics had to perform 2 intubation attempts in scenario B and 9% in scenario C.
CONCLUSIONS


Results of this simulation study indicate preliminary evidence, that the VieScope enables adequate endotracheal intubation in the pediatric setting. Further clinical studies are needed to confirm these results.",2020,The overall intubation success rate was 100% in all 3 scenarios.,"['Fifty-five paramedics with at least 2 years of clinical experience and without any previous experience with the VieScope participated in this study', 'several pediatric airway scenario', 'pediatric patients']",[],"['overall intubation success rate', 'number of intubation attempts, time to intubation, Cormack-Lehane grade, POGO score, and ease of use (using 1-100 scale', 'median intubation time', 'Overall intubation success rate']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.147591,The overall intubation success rate was 100% in all 3 scenarios.,"[{'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Maslanka', 'Affiliation': 'Medical Institute of Maria Sklodowska-Curie.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Szarpak', 'Affiliation': 'Comprehensive Cancer Center in Bialystok, Bialystok, Poland.'}, {'ForeName': 'Sanchit', 'Initials': 'S', 'LastName': 'Ahuja', 'Affiliation': 'Department of Anesthesiology, Pain Management and Perioperative Medicine, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'Departments of Outcomes Research and General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Smereka', 'Affiliation': 'Department of Emergency Medical Service, Wroclaw Medical University, Wroclaw, Poland.'}]",Medicine,['10.1097/MD.0000000000021084']
2747,32664145,A randomized double-blind placebo-controlled multicenter trial of Bushen Yisui and Ziyin Jiangzhuo formula for constipation in Parkinson disease.,"INTRODUCTION


Constipation is a common nonmotor symptom of Parkinson disease (PD). Constipation can also impact patient's quality of life. Chinese herbal medicines have been used for the treatment of constipation in PD. This trial will evaluate the efficacy and safety of a Chinese herbal formula Bushen Yisui and Ziyin Jiangzhuo (BYZJ) for the treatment of constipation in PD.
METHODS AND ANALYSIS


This randomized, double-blind, placebo-controlled, multicenter clinical trial will involve 4 hospitals in Beijing, China. The study will aim to recruit 90 PD patients with constipation between 30 and 80 years-of age with a score of 1 - 4 on the Hoehn and Yahr scale. Once recruited, Patients will be randomized into a BYZJ group or a placebo group in a 2:1 ratio. The trial will include a 1-week run-in period, a 4-week double-blind treatment period, a 4-week and a 12-week follow-up period. All patients will be educated about PD-related constipation during the run-in period. BYZJ granules and simulated granules will be administered twice daily for 4 weeks to the BYZJ group and the placebo group respectively. Assessments will be performed during run-in period, before the start of treatment (baseline, week 0), and at 4, 8, and 16 weeks. The primary outcome will be measured with the Constipation Severity Instrument, and secondary outcomes will be evaluated with the Patient Assessment of Constipation Quality of Life questionnaire, Bristol Stool Form Scale, Movement Disorders-Unified Parkinson Disease Rating Scale, Nonmotor Symptoms Scale, PD Sleep Scale, Parkinson Fatigue Scale-16. Laxative use (dose and frequency) will also be recorded. Intention-to-treat and per-protocol set analyses will be used to compare symptom improvement between the 2 groups. Any adverse events will be recorded.
DISCUSSION


If found effective and safe, BYZJ formula will be one of Chinese herb to treat constipation and even other nonmotor or motor symptoms in PD patients. The results will sustain the broader use of BYZJ formula in PD.",2020,BYZJ granules and simulated granules will be administered twice daily for 4 weeks to the BYZJ group and the placebo group respectively.,"['constipation in Parkinson disease', '90 PD patients with constipation between 30 and 80 years-of age with a score of 1 - 4 on the Hoehn and Yahr scale', '4 hospitals in Beijing, China', 'constipation in PD']","['Bushen Yisui and Ziyin Jiangzhuo formula', 'Chinese herbal formula Bushen Yisui and Ziyin Jiangzhuo (BYZJ', 'Chinese herbal medicines', 'placebo']","['efficacy and safety', 'Constipation Severity Instrument, and secondary outcomes will be evaluated with the Patient Assessment of Constipation Quality of Life questionnaire, Bristol Stool Form Scale, Movement Disorders-Unified Parkinson Disease Rating Scale, Nonmotor Symptoms Scale, PD Sleep Scale, Parkinson Fatigue Scale-16']","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4274667', 'cui_str': 'Hoehn and Yahr Scale'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C2352031', 'cui_str': 'bushen yisui'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.305455,BYZJ granules and simulated granules will be administered twice daily for 4 weeks to the BYZJ group and the placebo group respectively.,"[{'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Parkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.'}, {'ForeName': 'Zhengtang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Geriatrics Department, China Academy of Chinese Medical Sciences Xiyuan Hospital.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Medical Insurance Office, Dongzhimen Hospital of Beijing University of Chinese Medicine.'}, {'ForeName': 'Aoran', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'Traditional Chinese Medicine Rehabilitation Center, Beijing Rehabilitation Hospital, Capital Medical University.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Traditional Chinese Medicine Rehabilitation Center, Beijing Rehabilitation Hospital, Capital Medical University.'}, {'ForeName': 'XiaoYan', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital.'}, {'ForeName': 'Tianqing', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Neurology Department, Beijing Longfu Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Parkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.'}, {'ForeName': 'Aixian', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Parkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.'}, {'ForeName': 'Boyan', 'Initials': 'B', 'LastName': 'Fang', 'Affiliation': 'Parkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.'}]",Medicine,['10.1097/MD.0000000000021145']
2748,32664149,"Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial.","BACKGROUND


The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety profile for the treatment of obesity with or without metabolic risk factors are increasing.Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT). Thus, we designed this trial to explore the effects of GGT among obese women to accumulate optimal clinical evidence.Obesity is not only a component of metabolic syndrome and a factor associated with an increased risk of cardiovascular disease but is also related to insulin resistance. Previous research has confirmed that an increasing body mass index is highly related with increased risk of metabolic syndrome among overweight and obese individuals. The effectiveness of the Korean medicine herbal formula, GGT on obesity has been previously reported. The objective of this study is to assess the efficacy and safety of GGT for weight loss among obese Korean women with or without high risk for metabolic syndrome.
METHODS/DESIGN


This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported.
DISCUSSION


The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors.",2020,"Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT).","['160 participants', 'overweight and obese individuals', 'Korean obese women with or without metabolic syndrome risk factors', 'obese Korean women with or without high risk for metabolic syndrome', 'obese Korean women with or without metabolic risk factors', 'obese women']","['GGT', 'GGT or placebo', 'herbal medicine', 'placebo']","['body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes', 'efficacy and safety', 'change in weight from baseline', 'weight loss']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0740216', 'cui_str': 'Obesity screening'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",160.0,0.388628,"Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT).","[{'ForeName': 'Youme', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Department of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul.'}, {'ForeName': 'Hyun-Ju', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Oriental Medicine Research Institute, College of Korean Medicine, Gachon University, Seongnam.'}, {'ForeName': 'Hojun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Korean Rehabilitation Medicine, College of Korean Medicine, Dongguk University, Seoul.'}, {'ForeName': 'Jin-Bong', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Oriental Rehabilitation Medicine, Gwangju Oriental Hospital of Dongshin University, Gwangju.'}, {'ForeName': 'Young-Dal', 'Initials': 'YD', 'LastName': 'Kwon', 'Affiliation': 'Department of Korean Medicine Rehabilitation, Gwangju Medical Center, College of Korean Medicine, Wonkwang University, Gwangju.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, Seoul.'}, {'ForeName': 'Bo-Hyoung', 'Initials': 'BH', 'LastName': 'Jang', 'Affiliation': 'Department of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul.'}, {'ForeName': 'NamKwen', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Comparative Effectiveness Research & Economic Evaluation in Korean Medicine, Pusan National University, Yangsan.'}, {'ForeName': 'Yun-Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Department of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon University, Seongnam, Republic of Korea.'}, {'ForeName': 'Seong-Gyu', 'Initials': 'SG', 'LastName': 'Ko', 'Affiliation': 'Department of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul.'}]",Medicine,['10.1097/MD.0000000000021153']
2749,32664177,Effects of Kinect exergames on balance training among community older adults: A randomized controlled trial.,"BACKGROUND


Recent years have witnessed wide applications of exergames to balance training among the older adults. However, research concerning balance training with the use of Kinect for Xbox has remained scarce. While previous studies have shown the positive effects of exergames on improving balance and preventing falling among the older adults, there has been a paucity of empirical evidence supporting the superiority of Kinect exercise to conventional exercise over balance training among the older adults. Therefore, this study aimed to compare the feasibility, safety, and effectiveness of Kinect exercise against conventional exercise over balance training among the community older adults.
METHOD


A total of 20 participants were randomly assigned to the Kinect Exercise Group (N = 10) or the Conventional Exercise Group (N = 10) for a 5-week balance training (45 minutes a time, 2 times a week). Assessor blinding was employed to assess the participants' performance before and after the treatment, including 30-Second Chair Stand Test (30-sec CST), Timed Up and Go (TUG), Functional Reach Test (FRT), and One-Leg Stance Test (OLST) respectively with eyes open and closed. Subjective feeling of the intensity of pain and side effects were recorded throughout the investigation period. Nonparametric statistics was used for data analysis.
RESULTS


Within-group comparison between the pre-test and post-test indicated that significant differences existed in all of the 5 tests (30-sec CST, TUG, FRT, OLST with eyes open, and OLST with eyes closed) in the Kinect exercise group. To the Conventional exercise group, however, significant differences were only observed in 30-sec CST, FRT and OLST with eyes open. With regard to between-group comparison, significant differences were only found in FRT.
CONCLUSION


Such results indicated that both treatments were helpful in improving the participants' balance performance, that Kinect exercise was more effective in terms of overall balance ability, and that Kinect exercise was particularly beneficial to functional reach enhancement in comparison with traditional exercise. Kinect exercise could be a feasible, safe, and effective alternative for dynamic balance training among older adults.",2020,"To the Conventional exercise group, however, significant differences were only observed in 30-sec CST, FRT and OLST with eyes open.","['older adults', 'community older adults', 'A total of 20 participants']","['Kinect exergames', 'Kinect exercise to conventional exercise over balance training', 'Kinect Exercise Group (N\u200a=\u200a10) or the Conventional Exercise Group (N\u200a=\u200a10) for a 5-week balance training', 'Kinect exercise', 'Kinect exercise against conventional exercise over balance training']","['Subjective feeling of the intensity of pain and side effects', '30-Second Chair Stand Test (30-sec CST), Timed Up and Go (TUG), Functional Reach Test (FRT), and One-Leg Stance Test (OLST', 'balance training', 'FRT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",20.0,0.0207085,"To the Conventional exercise group, however, significant differences were only observed in 30-sec CST, FRT and OLST with eyes open.","[{'ForeName': 'Chi-Min', 'Initials': 'CM', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chi-Mei Medical Center.'}, {'ForeName': 'Jun Scott', 'Initials': 'JS', 'LastName': 'Chen Hsieh', 'Affiliation': 'Department of Foreign Languages and Literature, Asia University, Taichung.'}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Research, Chi Mei Medical Center, Tainan, Taiwan, ROC.'}, {'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chi-Mei Medical Center.'}, {'ForeName': 'Hao-Chiang Koong', 'Initials': 'HK', 'LastName': 'Lin', 'Affiliation': 'Department of Information and Learning Technology, National University of Tainan, Tainan.'}]",Medicine,['10.1097/MD.0000000000021228']
2750,32664244,Effect of PreAnaesThesia Computerized Health (PATCH) Assessment on Duration of Nurse-Patient Consultation and Patient Experience: A Pilot Trial.,"Preanaesthesia health assessment is gradually transitioning from paper-based, face-to-face assessment to digitized assessment, self-administered by the patient. This transition could potentially optimize the various goals of assessment, notably facilitating the efficient collection of the patient's health information. We have previously developed and validated a tablet application (PreAnaesThesia Computerized Health assessment application or ""PATCH"") for patients to conduct preanaesthesia self-assessment. In a randomized controlled trial, we sought to compare the duration of nurse-patient consultation and patient satisfaction between patients who underwent PATCH self-assessment vs. standard care nurse-led assessment. Fifty-two elective surgical patients were randomized to complete either PATCH assessment or standard care nurse-led assessment at an outpatient preoperative clinic. The duration of nurse-patient consultation was subsequently noted for all patients who also completed a satisfaction survey. The mean (SD) nurse-patient consultation times in the PATCH and standard care groups were comparable, at 11.5 (3.6) min and 12.2 (2.9) min, respectively ( p  = 0.703). Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups. Favorable perceptions of PATCH among users ranged between 41.7% and 79.2%. In conclusion, PATCH self-assessment can feasibly be introduced into current practice with comparable nurse-patient consultation times and patient satisfaction.",2020,"Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups.",['Fifty-two elective surgical patients'],"['PATCH self-assessment vs. standard care nurse-led assessment', 'PreAnaesThesia Computerized Health (PATCH) Assessment', 'tablet application (PreAnaesThesia Computerized Health assessment application or ""PATCH', 'PATCH assessment or standard care nurse-led assessment at an outpatient preoperative clinic']","['mean (SD) nurse-patient consultation times', 'duration of nurse-patient consultation', 'Overall satisfaction scores']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028658', 'cui_str': 'Nurse Patient Relations'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.0193419,"Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups.","[{'ForeName': 'Tarig', 'Initials': 'T', 'LastName': 'Osman', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Lew', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lum', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Chew', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Rajive', 'Initials': 'R', 'LastName': 'Dabas', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Ban Leong', 'Initials': 'BL', 'LastName': 'Sng', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17144972']
2751,32664369,Countering Vaccine Hesitancy among Pregnant Women in England: The Case of Boostrix-IPV.,"This study explored the effects of message framing on vaccine hesitancy for the antenatal whooping cough vaccine. The study also assessed whether the Theory of Planned Behaviour (TPB) constructs had any explanatory utility for vaccine intentions and behaviours in pregnant women. A between-subjects, cross-sectional design was employed. Participants ( n  = 282) were women who were pregnant (mean = 28 weeks, SD = 7.0), living in England and between 18 and 44 years of age. A self-report web-based survey was used to collect data. Participants were randomly assigned to read either (i) disease risk, (ii) myth busting, or (iii) control information before answering questions based on the TPB. No significant effects of message framing were found. Attitudes (Beta = 0.699;  p  < 0.001) and subjective norms (Beta = 0.262,  p  < 0.001) significantly predicted intention to vaccinate but perceived behavioural control did not. The TPB constructs accounted for 86% and 36% of the variance in vaccine intention and vaccine history respectively. Disease risk information did not influence vaccine acceptability in this sample of English pregnant women. The study offered preliminary evidence that interventions targeting constructs from the TPB may promote vaccine acceptability among pregnant women.",2020,No significant effects of message framing were found.,"['Participants ( n  = 282) were women who were pregnant (mean = 28 weeks, SD = 7.0), living in England and between 18 and 44 years of age', 'Pregnant Women in England', 'English pregnant women', 'pregnant women']","['read either (i) disease risk, (ii) myth busting, or (iii) control information before answering questions based on the TPB']","['behavioural control', 'vaccine acceptability', 'Attitudes']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",282.0,0.10224,No significant effects of message framing were found.,"[{'ForeName': 'Mairead', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Laura A V', 'Initials': 'LAV', 'LastName': 'Marlow', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17144984']
2752,32664375,Long-Term Influence of the Practice of Physical Activity on the Self-Perceived Quality of Life of Women with Breast Cancer: A Randomized Controlled Trial.,"Background:  There is still no consensus on the most suitable interventions for exercise practice in breast cancer survivors. Therefore, the aim of this study was to evaluate the effect of a two-year physical activity intervention (strength, aqua fitness and aerobic exercise programs) on the self-perceived quality of life and physical functionality of female breast cancer survivors.  Methods:  A randomized, controlled, experimental trial with a sample of 316 women (63 ± 7 years), who had been diagnosed with breast cancer. The evaluations were performed using the Rikli & Jones Senior Fitness Test, and the Short Form 12 Health Survey (SF-12).  Results:  The participants in the strength program showed statistically significant improvements in all the items of the SF-12. The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12. The participants in the aerobic program showed a progressive deterioration of Vitality and Mental Health.  Conclusion:  When assigning breast cancer survivors to an exercise program, the preferential or predominant activity should include strength exercises. On the other hand, as the second choice, those patients with particularly low levels of Vitality or Physical Limitations will show greater improvement with an aqua fitness program.",2020,"The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12.","['breast cancer survivors', 'Women with Breast Cancer', 'female breast cancer survivors', '316 women (63 ± 7 years), who had been diagnosed with breast cancer']","['two-year physical activity intervention (strength, aqua fitness and aerobic exercise programs']","['Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12', 'self-perceived quality of life and physical functionality', 'progressive deterioration of Vitality and Mental Health', 'Self-Perceived Quality of Life', 'SF-12']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",316.0,0.0362931,"The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12.","[{'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'García-Soidán', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Pérez-Ribao', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Leirós-Rodríguez', 'Affiliation': 'Faculty of Physical Therapy, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Anxela', 'Initials': 'A', 'LastName': 'Soto-Rodríguez', 'Affiliation': 'Health Service from Galicia (SERGAS), Galician Health Services-Ourense Hospital, 32005 Ourense, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17144986']
2753,32664486,"A Phase 2a Randomized, Double-Blind, Dose-Optimizing Study to Evaluate the Immunogenicity and Safety of a Bivalent DNA Vaccine for Hemorrhagic Fever with Renal Syndrome Delivered by Intramuscular Electroporation.","Hantaan virus (HTNV) and Puumala virus (PUUV) are pathogenic hantaviruses found in Asia and Europe, respectively. DNA vaccines targeting the envelope glycoproteins of these viruses have been constructed and found to elicit neutralizing antibodies when delivered to humans by various technologies including intramuscular electroporation. Here, we report findings from a Phase 2a clinical trial of a combined HTNV/PUUV DNA vaccine delivered at varying doses and administration schedules using the Ichor Medical Systems TriGrid intramuscular electroporation delivery technology. The study was designed to characterize the effects of DNA vaccine dose and number of administrations on the frequency and magnitude of immunological response. Subjects ( n  = 120) were divided into four cohorts. Cohorts 1 and 2 received a dose of 2 mg of DNA (1 mg per plasmid), and cohorts 3 and 4 received a dose of 1 mg of DNA (0.5 mg per plasmid) each vaccination. Each of the four cohorts received a series of four administrations (days 0, 28, 56 and 168). For cohorts 1 and 3, the DNA vaccine candidate was delivered at each of the four administrations. For cohorts 2 and 4, in order to maintain blinding, subjects received the DNA vaccine on days 0, 56 and 168, but on day 28 received only the phosphate buffered saline vehicle rather the DNA vaccine. Sera were collected on days 0, 28, 56, 84, 140, 168, 196, 252 and 365 and evaluated for the presence of neutralizing antibodies by PUUV and HTNV pseudovirion neutralization assays (PsVNAs). Day 84 was also evaluated by a plaque reduction neutralization test (PRNT). Overall the PsVNA50 geometric mean titers (GMTs) and seropositivity rates among cohorts were similar. Cohort 3 exhibited the highest frequency of subjects that became seropositive to both PUUV and HTNV after vaccination, the highest peak GMT against both viruses, and the highest median titers against both viruses.",2020,"Cohort 3 exhibited the highest frequency of subjects that became seropositive to both PUUV and HTNV after vaccination, the highest peak GMT against both viruses, and the highest median titers against both viruses.","['Hemorrhagic Fever with Renal Syndrome Delivered by Intramuscular Electroporation', 'Subjects ( n  = 120']","['combined HTNV/PUUV DNA vaccine', 'DNA', 'phosphate buffered saline vehicle rather the DNA vaccine', 'Bivalent DNA Vaccine', 'DNA vaccine']","['Immunogenicity and Safety', 'PsVNA50 geometric mean titers (GMTs) and seropositivity rates', 'plaque reduction neutralization test (PRNT']","[{'cui': 'C0019101', 'cui_str': 'Hemorrhagic fever with renal syndrome'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086384', 'cui_str': 'Hantaan virus'}, {'cui': 'C0205790', 'cui_str': 'Puumala virus'}, {'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}]",120.0,0.102299,"Cohort 3 exhibited the highest frequency of subjects that became seropositive to both PUUV and HTNV after vaccination, the highest peak GMT against both viruses, and the highest median titers against both viruses.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hooper', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Paolino', 'Affiliation': 'Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kwilas', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Josleyn', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Somerville', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wisniewski', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hill', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanchez-Lockhart', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hannaman', 'Affiliation': 'Ichor Medical Systems, Inc., San Diego, CA 92121, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Schmaljohn', 'Affiliation': 'Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA.'}]",Vaccines,['10.3390/vaccines8030377']
2754,32664535,Manipulative Therapy Plus Ankle Therapeutic Exercises for Adolescent Baseball Players with Chronic Ankle Instability: A Single-Blinded Randomized Controlled Trial.,"Manipulative therapies and exercises are commonly used for the management of chronic ankle instability (CAI), but there is no evidence regarding the efficacy of high-velocity low-amplitude manipulation (HVLA) in addition to ankle therapeutic exercise to improve CAI in adolescent baseball players (ABP). To compare the effects of HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone on ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability in ABP with CAI, a single-blinded randomized controlled trial was conducted. A total of 31 ABP with CAI were randomly allocated to the intervention (n = 16) or control (n = 15) groups. The intervention group received HVLA plus resistance exercise twice a week for 4 weeks, while the control group received resistance exercise alone. Ankle status, pain intensity, PPT, ROM, and balance ability were assessed before and after the intervention. The American Orthopedic Foot and Ankle Society scores showed significant group and time interactions (total,  p  = 0.002; pain,  p  < 0.001; alignment,  p  = 0.001). There were significant group and time interactions in pain intensity (resting pain,  p  = 0.008; movement pain,  p  < 0.001). For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026). The unipedal stance of the balance ability showed significant group and time interactions in path length ( p  = 0.006) and velocity ( p  = 0.006). Adding HVLA to resistance exercises may be synergistically effective in improving the ankle status, pain intensity, ROM, and balance ability in ABP with CAI.",2020,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","['A total of 31 ABP with CAI', 'Adolescent Baseball Players with Chronic Ankle Instability', 'adolescent baseball players (ABP']","['Manipulative Therapy Plus Ankle Therapeutic Exercises', 'Manipulative therapies and exercises', 'resistance exercise alone', 'HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone', 'HVLA plus resistance exercise']","['ankle status, pain intensity, ROM, and balance ability', 'time interactions in path length', 'Ankle status, pain intensity, PPT, ROM, and balance ability', 'time interactions in pain intensity (resting pain,  p  = 0.008; movement pain', 'time interactions on dorsiflexion', 'ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}]","[{'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}]",31.0,0.0724231,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Suk-Chan', 'Initials': 'SC', 'LastName': 'Hahm', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17144997']
2755,32664548,Effects of Elastic Resistance Exercise on Postoperative Outcomes Linked to the ICF Core Sets for Osteoarthritis after Total Knee Replacement in Overweight and Obese Older Women with Sarcopenia Risk: A Randomized Controlled Trial.,"(1) Background: Knee osteoarthritis (KOA) and aging are associated with high sarcopenia risk; sarcopenia may further affect outcomes after total knee replacement (TKR). Elastic resistance exercise training (RET) limits muscle attenuation in older adults. We aimed to identify the effects of post-TKR elastic RET on lean mass (LM) and functional outcomes in overweight and obese older women with KOA by using the brief International Classification of Functioning, Disability and Health Core Set for osteoarthritis (Brief-ICF-OA). (2) Methods: Eligible women aged ≥60 years who had received unilateral primary TKR were randomly divided into an experimental group (EG), which received postoperative RET twice weekly for 12 weeks, and a control group (CG), which received standard care. The primary and secondary outcome measures were LM and physical capacity, respectively, and were linked to the Brief-ICF-OA. The assessment time points were 2 weeks prior to surgery (T 0 ) and postoperative at 1 month (T 1 ; before RET) and 4 months (T 2 ; upon completion of RET) of follow-up. An independent t test with an intention-to-treat analysis was conducted to determine the between-group differences in changes of outcome measures at T 1  and T 2  from T 0 . (3) Results: Forty patients (age: 70.9 ± 7.3 years) were randomly assigned to the EG ( n  = 20) or CG ( n  = 20). At T 2 , the EG exhibited significantly greater improvements in leg LM (mean difference (MD) = 0.86 kg,  p  = 0.004) and gait speed (MD = 0.26 m/s,  p  = 0.005) compared with the CG. Furthermore, the EG generally obtained significantly higher odds ratios than the CG for treatment success for most Brief-ICF-OA categories (all  p  < 0.001). Conclusions: Early intervention of elastic RET after TKR yielded positive postoperative outcomes based on the Brief-ICF-OA. The findings of this study may facilitate clinical decision-making regarding the optimal post-TKR rehabilitation strategy for older women with KOA.",2020,"At T 2 , the EG exhibited significantly greater improvements in leg LM (mean difference (MD) = 0.86 kg,  p  = 0.004) and gait speed (MD = 0.26 m/s,  p  = 0.005) compared with the CG.","['Osteoarthritis after Total Knee Replacement in Overweight and Obese Older Women with Sarcopenia Risk', 'older adults', 'Forty patients (age: 70.9 ± 7.3 years', 'overweight and obese older women with KOA by using the brief International Classification of Functioning, Disability and Health Core Set for osteoarthritis (Brief-ICF-OA', '2) Methods: Eligible women aged ≥60 years who had received unilateral primary TKR', 'older women with KOA']","['Elastic resistance exercise training (RET', 'postoperative RET', 'Elastic Resistance Exercise', 'CG', 'post-TKR elastic RET']","['leg LM', 'lean mass (LM) and functional outcomes', 'LM and physical capacity, respectively, and were linked to the Brief-ICF-OA', 'gait speed']","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",40.0,0.0549851,"At T 2 , the EG exhibited significantly greater improvements in leg LM (mean difference (MD) = 0.86 kg,  p  = 0.004) and gait speed (MD = 0.26 m/s,  p  = 0.005) compared with the CG.","[{'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Yen-Shuo', 'Initials': 'YS', 'LastName': 'Chiu', 'Affiliation': 'Department of Orthopedics, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Jan-Wen', 'Initials': 'JW', 'LastName': 'Ku', 'Affiliation': 'Department of Radiology, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Shih-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Tsan-Hon', 'Initials': 'TH', 'LastName': 'Liou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}]",Journal of clinical medicine,['10.3390/jcm9072194']
2756,32664552,Pain Neuroscience Education Plus Usual Care Is More Effective Than Usual Care Alone to Improve Self-Efficacy Beliefs in People with Chronic Musculoskeletal Pain: A Non-Randomized Controlled Trial.,"Self-efficacy beliefs are associated with less physical impairment and pain intensity in people with chronic pain. Interventions that build self-efficacy beliefs may foster behavioral changes among this population. A non-randomized trial has been carried out to evaluate the effectiveness of pain neuroscience education (PNE) plus usual care in modifying self-efficacy beliefs, pain intensity, pain interference and analgesics consumption in people with chronic musculoskeletal pain. Participants were allocated to an experimental (PNE plus usual care,  n =  49) and a control (usual care alone,  n =  51) group. The primary outcome was self-efficacy beliefs (Chronic Pain Self-Efficacy Scale), and the secondary outcomes were pain intensity, pain interference (Graded Chronic Pain Scale) and analgesics consumption. The participant's pain knowledge (revised Neurophysiology of Pain Questionnaire) after PNE intervention was also assessed to analyze its influence on every outcome measure. All the outcome measures were assessed at the baseline and at four-week and four-month follow-ups. PNE plus usual care was more effective than usual care alone to increase self-efficacy beliefs and decrease pain intensity and pain interference at all follow-up points. No differences between groups were found in terms of analgesics consumption. Knowledge of pain neurophysiology did not modify the effects of PNE plus usual care in any of the outcome measures. These results should be taken with caution because of the non-randomized nature of this design, the limited follow-ups and the uncertainty of the presence of clinical changes in self-efficacy for participants. Larger, methodological sound trials are needed.",2020,Knowledge of pain neurophysiology did not modify the effects of PNE plus usual care in any of the outcome measures.,"['people with chronic musculoskeletal pain', 'people with chronic pain', 'People with Chronic Musculoskeletal Pain']","['Usual Care Alone', 'pain neuroscience education (PNE) plus usual care', 'experimental (PNE plus usual care,  n =  49) and a control (usual care alone,  n =  51) group']","['pain knowledge (revised Neurophysiology of Pain Questionnaire', 'physical impairment and pain intensity', 'analgesics consumption', 'self-efficacy beliefs and decrease pain intensity and pain interference', 'pain intensity, pain interference and analgesics consumption', 'self-efficacy beliefs (Chronic Pain Self-Efficacy Scale), and the secondary outcomes were pain intensity, pain interference (Graded Chronic Pain Scale) and analgesics consumption', 'Self-Efficacy Beliefs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231171', 'cui_str': 'Physical impairment'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0923249,Knowledge of pain neurophysiology did not modify the effects of PNE plus usual care in any of the outcome measures.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rondon-Ramos', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. Las Lagunas, 29650 Mijas, Málaga, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martinez-Calderon', 'Affiliation': 'Universidad de Málaga, Facultad de Ciencias de la Salud, Departamento de Fisioterapia, 29071 Málaga, Spain.'}, {'ForeName': 'Juan Luis', 'Initials': 'JL', 'LastName': 'Diaz-Cerrillo', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. La Carihuela, 29620 Torremolinos, Málaga, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Rivas-Ruiz', 'Affiliation': 'Research Unit, Agencia Sanitaria Costa del Sol, 29603 Marbella, Málaga, Spain.'}, {'ForeName': 'Gina Rocio', 'Initials': 'GR', 'LastName': 'Ariza-Hurtado', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. San Pedro de Alcántara, 29670 Marbella, Málaga, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Clavero-Cano', 'Affiliation': 'Servicio Andaluz de Salud, Distrito de Atención Primaria Costa del Sol, U.G.C. Las Albarizas, 29600 Marbella, Málaga, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Luque-Suarez', 'Affiliation': 'Universidad de Málaga, Facultad de Ciencias de la Salud, Departamento de Fisioterapia, 29071 Málaga, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9072195']
2757,32664567,Artificial Saliva in Diabetic Xerostomia (ASDIX): Double Blind Trial of Aldiamed ®  Versus Placebo.,"Xerostomia is a symptom frequently present in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). In the present trial, the activity of an artificial saliva (aldiamed ®  spray) in comparison to a placebo spray were used to evaluate the xerostomia and the saliva antioxidant capacity (SAT). Sixty patients of both genders with T1DM or T2DM were randomized into two groups of 30 subjects each. The experiment was a double-blind study approved by the Ethics Committee of the ""G. d'Annunzio University"" of Chieti and Pescara. Moreover, measurements of the stimulated saliva flow rate and the ultrasonography of the submandibular and parotid glands were performed at both the study time points. The results demonstrated statistically significant differences between the treatments in terms of the xerostomia average score. Specifically, the values were at baseline and after 30 days 2.9 ± 1.31 and 3.0 ± 1.44 and 1.4 ± 1.48 and 2.4 ± 0.99 for aldiamed ®  spray and the placebo, respectively. Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.",2020,"Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.","['Diabetic Xerostomia (ASDIX', 'patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM', 'Sixty patients of both genders with T1DM or T2DM']",['Aldiamed ®  Versus Placebo'],"['stimulated saliva flow rate', 'xerostomia and the saliva antioxidant capacity (SAT', 'salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands', 'xerostomia average score', 'Xerostomia']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0930553', 'cui_str': 'Major salivary gland structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.205281,"Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.","[{'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Sinjari', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Feragalli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Cornelli', 'Affiliation': 'Stritch School of Medicine, Loyola University Chicago, Maywood, IL 60611, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Belcaro', 'Affiliation': 'Irwin Labs, University of Chieti, 65010 Spoltore, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Vitacolonna', 'Affiliation': 'Department of Medicine and Aging Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Santilli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Imena', 'Initials': 'I', 'LastName': 'Rexhepi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': ""D'Addazio"", 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zuccari', 'Affiliation': 'Marchegiani Analysis Laboratory, 65122 Pescara, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Caputi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9072196']
2758,32668012,Sustained improvement of surgical scar appearance one year after early intervention with nonablative fractional laser treatment: a randomized controlled split-wound trial.,"Early laser treatment during wound healing has increasingly gained focus to improve scar formation 1  . The majority of trials addressing early laser intervention for improving scar formation present short follow-up time of 1-3 months 2  . Considering the pathophysiology of scar formation, a scar is not mature until a year post-injury. Thus, the effect of early laser treatment should be evaluated at least one year after scar intervention, and knowledge about long-term effect is lacking 3-7  .",2020,The majority of trials addressing early laser intervention for improving scar formation present short follow-up time of 1-3 months 2  .,[],"['nonablative fractional laser treatment', 'laser intervention']","['surgical scar appearance', 'scar formation']",[],"[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0276531,The majority of trials addressing early laser intervention for improving scar formation present short follow-up time of 1-3 months 2  .,"[{'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Grove', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Banzhaf', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Paasch', 'Affiliation': 'Department of Dermatology, Venerology and Allergology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nast', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Haedersdal', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}]",The British journal of dermatology,['10.1111/bjd.19400']
2759,32668036,When to install the endodontic post? First visit with root canal filling versus a separate second-visit for post-restoration: A randomized controlled Trial.,"BACKGROUND


The vibrations created by post-space preparation during the first-visit for endodontic treatment could have a significant effect on the intensity of postoperative pain than that association with post-space preparation at the second appointment.
OBJECTIVE


The aim of this study was to evaluate the effect of vibrations generated during post installation, on postoperative pain in endodontically treated teeth.
METHODS


One hundred patients with asymptomatic teeth requiring primary root canal treatment and post installation were enrolled in this study. Fifty patients underwent endodontic treatment with post installation at the first visit (group 1), while the remaining 50 patients underwent post installation at the second visit (group 2). The intensity of postoperative pain in both groups was evaluated 1, 2, 3 days and 1 week after the first visit using the visual analog scale. The time required to achieve complete pain relief for each patient was also recorded. The patients' age, sex, tooth type, size of the periapical lesion and time required for complete postoperative pain relief for each tooth were recorded.
RESULTS


The pain intensity score was significantly higher in group 1 than group 2 (P < .05). No significant differences were observed in parameters such as sex, tooth type, jaw, and size of the periapical lesion (P > .05), whereas age had a significant effect on the postoperative pain scores (P < .05).
CONCLUSION


Vibrations occurring during post installation on the same visit as that of root canal filling may increase the postoperative pain.",2020,The pain intensity score was significantly higher in group 1 than group 2 (P < .05).,"['One hundred patients with asymptomatic teeth requiring primary root canal treatment and post installation were enrolled in this study', 'Fifty patients underwent']",['endodontic treatment'],"['parameters such as sex, tooth type, jaw, and size of the periapical lesion', 'postoperative pain scores', 'postoperative pain', 'intensity of postoperative pain', 'pain intensity score', 'time required to achieve complete pain relief']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",100.0,0.0630033,The pain intensity score was significantly higher in group 1 than group 2 (P < .05).,"[{'ForeName': 'Tan Firat', 'Initials': 'TF', 'LastName': 'Eyuboglu', 'Affiliation': 'Department of Endodontics, School of Dentistry, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Dental Research Institute, Pusan National University, Yangsan, Korea.'}]",Journal of oral rehabilitation,['10.1111/joor.13056']
2760,32668039,Effectiveness of web-based distance education for parents in the prevention of emotional neglect and abuse: A randomized controlled study.,"PURPOSE


The aim of this study was to determine the efficacy of web-based distance education for the prevention of child emotional neglect and abuse by increasing parental awareness of emotional abuse and appropriate attitudes toward child-rearing.
DESIGN AND METHODS


This study had a quasi-experimental, randomized controlled design. The study sample included a total of 60 parents who had taken their child to a pediatric outpatient clinic in Turkey. Of 60 parents, 30 were randomly assigned to an experimental group and 30 were randomly assigned to a control group. Data were collected using the Personal Characteristics Form, the Recognition of Emotional Maltreatment Scale (REMS) and the Parental Attitude Research Instrument (PARI). The experimental group was offered a 6-week web-based distance education program focusing on the prevention of child emotional neglect and abuse.
FINDINGS


There was no significant difference between the posttest scores of the experimental and control groups (P > .05). However, a significant difference was found between pretest and posttest scores of the experimental group for the REMS and its subscales and for the overprotective mothering and strict discipline subscales of the PARI (P < .05).
CONCLUSION


The 6-week web-based distance education has the potential to increase parental awareness of child-rearing and emotional abuse.
PRACTICE IMPLICATIONS


Web-based distance education has a positive effect on parenting attitudes and emotional abuse awareness levels. This form of parent education should, therefore, be utilized further in clinical practice.",2020,"The 6-week web-based distance education has the potential to increase parental awareness of child-rearing and emotional abuse.
","['parents in the prevention of emotional neglect and abuse', '60 parents', '60 parents who had taken their child to a pediatric outpatient clinic in Turkey', 'child emotional neglect and abuse by increasing parental awareness of emotional abuse and appropriate attitudes toward child-rearing']","['web-based distance education', '6-week web-based distance education program focusing on the prevention of child emotional neglect and abuse']","['Recognition of Emotional Maltreatment Scale (REMS) and the Parental Attitude Research Instrument (PARI', 'overprotective mothering and strict discipline subscales of the PARI']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008091', 'cui_str': 'Child Rearing'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600562', 'cui_str': 'Distance Education'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",60.0,0.0313589,"The 6-week web-based distance education has the potential to increase parental awareness of child-rearing and emotional abuse.
","[{'ForeName': 'Kübra', 'Initials': 'K', 'LastName': 'Gülirmak', 'Affiliation': 'Department of Psychiatric Nursing Samsun, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Oya Sevcan', 'Initials': 'OS', 'LastName': 'Orak', 'Affiliation': 'Department of Psychiatric Nursing Samsun, Ondokuz Mayıs University, Samsun, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12580']
2761,32668087,Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder.,"BACKGROUND


Alterations in resting-state functional connectivity (rsFC) have been reported in posttraumatic stress disorder (PTSD). Here, we examined pre- and post-treatment rsFC during a randomized clinical trial to characterize alterations and examine predictors of treatment response.
METHODS


Sixty-four combat veterans with PTSD were randomly assigned to prolonged exposure (PE) plus placebo, sertraline plus enhanced medication management, or PE plus sertraline. Symptom assessment and resting-state functional magnetic resonance imaging (fMRI) scans occurred before and after treatment. Twenty-nine trauma-exposed combat veterans without PTSD served as a control group at intake. Seed-based and region of interest (ROI)-to-ROI connectivities, as well as an exploratory connectome-based approach were used to analyze rsFC patterns. Based on previously reported findings, analyses focused on Salience Network (SN) and Default-Mode Network (DMN).
RESULTS


At intake, patients with PTSD showed greater DMN-dorsal attention network (DAN) connectivity (between ventromedial prefrontal cortex and superior parietal lobule; family-wise error corrected p = .011), greater SN-DAN connectivity (between insula and middle frontal gyrus; corrected p = .003), and a negative correlation between re-experiencing symptoms and within-DMN connectivity (between posterior cingulate cortex (PCC) and middle temporal gyrus; corrected p < .001). We also found preliminary evidence for associations between rsFC and treatment response. Specifically, high responders (≥50% PTSD symptom improvement), compared with low responders, had greater SN-DMN segregation (i.e., less pre-treatment amygdala-PCC connectivity; p = .011) and lower pre-treatment global centrality (p = .042).
CONCLUSIONS


Our findings suggest neural abnormalities in PTSD and may inform future research examining neural biomarkers of PTSD treatment response.",2020,"Specifically, high responders (≥50% PTSD symptom improvement), compared with low responders, had greater SN-DMN segregation (i.e., less pre-treatment amygdala-PCC connectivity; p = .011) and lower pre-treatment global centrality (p = .042).
","['Twenty-nine trauma-exposed combat veterans without PTSD served as a control group at intake', 'Sixty-four combat veterans with PTSD', 'posttraumatic stress disorder']","['prolonged exposure (PE) plus placebo, sertraline plus enhanced medication management, or PE plus sertraline']","['greater DMN-dorsal attention network (DAN) connectivity', 'Symptom assessment and resting-state functional magnetic resonance imaging (fMRI) scans', 'greater SN-DAN connectivity', 'SN-DMN segregation', 'Salience Network (SN) and Default-Mode Network (DMN']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0080141', 'cui_str': 'Racial Segregation'}]",,0.0394609,"Specifically, high responders (≥50% PTSD symptom improvement), compared with low responders, had greater SN-DMN segregation (i.e., less pre-treatment amygdala-PCC connectivity; p = .011) and lower pre-treatment global centrality (p = .042).
","[{'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'Sheynin', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Angstadt', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, Atlanta VA Healthcare System, Decatur, Georgia.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}]",Depression and anxiety,['10.1002/da.23075']
2762,32668113,Trial of Roflumilast Cream for Chronic Plaque Psoriasis.,"BACKGROUND


Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis.
METHODS


In this phase 2b, double-blind trial, we randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) cream once daily for 12 weeks. The primary efficacy outcome was the investigator's global assessment (IGA) of a status of clear or almost clear at week 6 (assessed on a 5-point scale of plaque thickening, scaling, and erythema; a score of 0 indicates clear, 1 almost clear, and 4 severe). Secondary outcomes included an IGA score indicating clear or almost clear plus a 2-grade improvement in the IGA score for the intertriginous area and the change in the Psoriasis Area and Severity Index (PASI) score (range, 0 to 72, with higher scores indicating worse disease). Safety was also assessed.
RESULTS


Among 331 patients who underwent randomization, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream. An IGA score indicating clear or almost clear at week 6 was observed in 28% of the patients in the roflumilast 0.3% group, in 23% in the roflumilast 0.15% group, and in 8% in the vehicle group (P<0.001 and P = 0.004 vs. vehicle for roflumilast 0.3% and 0.15%, respectively). Among the approximately 15% of patients overall who had baseline intertriginous psoriasis of at least mild severity, an IGA score at week 6 indicating clear or almost clear plus a 2-grade improvement in the intertriginous-area IGA score occurred in 73% of the patients in the roflumilast 0.3% group, 44% of those in the roflumilast 0.15% group, and 29% of those in the vehicle group. The mean baseline PASI scores were 7.7 in the roflumilast 0.3% group, 8.0 in the roflumilast 0.15% group, and 7.6 in the vehicle group; the mean change from baseline at week 6 was -50.0%, -49.0%, and -17.8%, respectively. Application-site reactions occurred with similar frequency in the roflumilast groups and the vehicle group.
CONCLUSIONS


Roflumilast cream administered once daily to affected areas of psoriasis was superior to vehicle cream in leading to a state of clear or almost clear at 6 weeks. Longer and larger trials are needed to determine the durability and safety of roflumilast in psoriasis. (Funded by Arcutis Biotherapeutics; ARQ-151 201 ClinicalTrials.gov number, NCT03638258.).",2020,"CONCLUSIONS


Roflumilast cream administered once daily to affected areas of psoriasis was superior to vehicle cream in leading to a state of clear or almost clear at 6 weeks.","['Chronic Plaque Psoriasis', 'adults with plaque psoriasis in a 1:1:1 ratio to use', '331 patients who underwent randomization']","['Roflumilast Cream', 'Roflumilast cream', 'roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream', 'roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) cream']","['intertriginous-area IGA score', 'Safety', 'IGA score', ""investigator's global assessment (IGA) of a status of clear or almost clear at week 6 (assessed on a 5-point scale of plaque thickening, scaling, and erythema; a score of 0 indicates clear, 1 almost clear, and 4 severe"", 'IGA score indicating clear or almost clear plus a 2-grade improvement in the IGA score for the intertriginous area and the change in the Psoriasis Area and Severity Index (PASI) score', 'Application-site reactions', 'mean baseline PASI scores', 'durability and safety']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0205268', 'cui_str': 'Intertriginous'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0151505', 'cui_str': 'Application site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",331.0,0.233761,"CONCLUSIONS


Roflumilast cream administered once daily to affected areas of psoriasis was superior to vehicle cream in leading to a state of clear or almost clear at 6 weeks.","[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Leon H', 'Initials': 'LH', 'LastName': 'Kircik', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Zoe D', 'Initials': 'ZD', 'LastName': 'Draelos', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kempers', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Zirwas', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Osborne', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Trotman', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Navale', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Merritt', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Berk', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Welgus', 'Affiliation': ""From the Icahn School of Medicine at Mount Sinai, New York (M.G.L., L.H.K.); Probity Medical Research and K. Papp Clinical Research, Waterloo (K.A.P.), and the SkiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough (M.J.G.) - both in Ontario, Canada; Henry Ford Medical Center, Detroit (L.S.G.); Indiana Medical Center, Indianapolis (L.H.K.); Physicians Skin Care and DermResearch, Louisville, KY (L.H.K.); Dermatology Consulting Services, High Point, NC (Z.D.D.); Minnesota Clinical Study Center, Fridley (S.E.K.); Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley (M.Z.); and Arcutis Biotherapeutics, Westlake Village (K.S., D.W.O., L.N., C.M., D.R.B., H.W.), and ML Trotman Consulting, Newbury Park (M.-L.T.) - both in California.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2000073']
2763,32668408,Sodium Bicarbonate Supplementation Does Not Improve Running Anaerobic Sprint Test Performance in Semiprofessional Adolescent Soccer Players.,"Ergogenic strategies have been studied to alleviate muscle fatigue and improve sports performance. Sodium bicarbonate (NaHCO3) has improved repeated sprint performance in adult team-sports players, but the effect for adolescents is unknown. The aim of the present study was to evaluate the effect of NaHCO3 supplementation on repeated sprint performance in semiprofessional adolescent soccer players. In a double-blind, placebo-controlled, crossover trial, 15 male semiprofessional adolescent soccer players (15 ± 1 years; body fat 10.7 ± 1.3%) ingested NaHCO3 or a placebo (sodium chloride) 90 min before performing the running anaerobic sprint test (RAST). A countermovement jump was performed before and after the RAST, and ratings of perceived exertion, blood parameters (potential hydrogen and bicarbonate concentration), and fatigue index were also evaluated. Supplementation with NaHCO3 promoted alkalosis, as demonstrated by the increase from the baseline to preexercise, compared with the placebo (potential hydrogen: +0.07 ± 0.01 vs. -0.00 ± 0.01, p < .001 and bicarbonate: +3.44 ± 0.38 vs. -1.45 ± 0.31 mmol/L, p < .001); however, this change did not translate into an improvement in RAST total time (32.12 ± 0.30 vs. 33.31 ± 0.41 s, p = .553); fatigue index (5.44 ± 0.64 vs. 6.28 ± 0.64 W/s, p = .263); ratings of perceived exertion (7.60 ± 0.33 vs. 7.80 ± 0.10 units, p = .525); countermovement jump pre-RAST (32.21 ± 3.35 vs. 32.05 ± 3.51 cm, p = .383); or countermovement jump post-RAST (31.70 ± 0.78 vs. 32.74 ± 1.11 cm, p = .696). Acute NaHCO3 supplementation did not reduce muscle fatigue or improve RAST performance in semiprofessional adolescent soccer players. More work assessing supplementation in this age group is required to increase understanding in the area.",2020,"Supplementation with NaHCO3 promoted alkalosis, as demonstrated by the increase from the baseline to preexercise, compared with the placebo (potential hydrogen: +0.07 ± 0.01 vs. -0.00 ± 0.01, p < .001 and bicarbonate: +3.44 ± 0.38","['semiprofessional adolescent soccer players', 'adult team-sports players', 'Semiprofessional Adolescent Soccer Players', '15 male semiprofessional adolescent soccer players (15 ± 1\xa0years; body fat 10.7 ± 1.3%) ingested']","['Sodium Bicarbonate Supplementation', 'NaHCO3 supplementation', 'NaHCO3 or a placebo (sodium chloride', 'bicarbonate', 'running anaerobic sprint test (RAST', 'Acute NaHCO3 supplementation', 'Sodium bicarbonate (NaHCO3', 'placebo']","['ratings of perceived exertion, blood parameters (potential hydrogen and bicarbonate concentration), and fatigue index', 'fatigue index', 'repeated sprint performance', 'Running Anaerobic Sprint Test Performance', 'RAST total time', 'muscle fatigue or improve RAST performance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",15.0,0.181124,"Supplementation with NaHCO3 promoted alkalosis, as demonstrated by the increase from the baseline to preexercise, compared with the placebo (potential hydrogen: +0.07 ± 0.01 vs. -0.00 ± 0.01, p < .001 and bicarbonate: +3.44 ± 0.38","[{'ForeName': 'Rodrigo Dos Santos', 'Initials': 'RDS', 'LastName': 'Guimarães', 'Affiliation': 'Federal University of Goiás (UFG).'}, {'ForeName': 'Alcides Correa', 'Initials': 'AC', 'LastName': 'de Morais Junior', 'Affiliation': 'Federal University of Goiás (UFG).'}, {'ForeName': 'Raquel Machado', 'Initials': 'RM', 'LastName': 'Schincaglia', 'Affiliation': 'Federal University of Goiás (UFG).'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'University of São Paulo.'}, {'ForeName': 'Gustavo Duarte', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Federal University of Goiás (UFG).'}, {'ForeName': 'João Felipe', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Federal University of Goiás (UFG).'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0031']
2764,32668410,Randomized Clinical Trial of Water-Based Aerobic Training in Older Women (WATER Study): Functional Capacity and Quality of Life Outcomes.,"BACKGROUND


The purpose of this study was to investigate the effects of 2 water-based aerobic training programs on functional capacity and quality of life (QoL) of older women.
DESIGN


Randomized clinical trial.
METHODS


A total of 41 women (64.3 [3.1] y) were randomized into a continuous (CTG) and an interval (ITG) water-based aerobic training group. Training programs were performed with exercise intensity based on rating of perceived exertion throughout 12 weeks (twice a week). Functional tests with and without dual-task and QoL questionnaire were applied pretraining and posttraining. Per protocol and intention to treat analysis were conducted using generalized estimating equations, with Bonferroni post hoc test (α = .05).
RESULTS


The per protocol analysis showed an increase in the 30-second chair stand (6% [12%] vs 18% [13%]), 6-minute walk (4% [7%] vs 2% [8%]), and 5-m habitual gait velocity (6% [11%] vs 4% [7%]) tests after CTG and ITG training groups. In addition, the intention to treat analysis revealed an increase in the 30-second chair stand test (7% [13%] vs 12% [13%]) and physical domain of QoL (8% [26%] vs 14% [22%]) after CTG and ITG training groups, as well as an increase in the gait velocity with verbal task after CTG (6% [11%]).
CONCLUSIONS


Both water-based aerobic training programs induced similar improvements in the functional capacity and maintained the QoL perception in older women.",2020,"CONCLUSIONS


Both water-based aerobic training programs induced similar improvements in the functional capacity and maintained the QoL perception in older women.","['older women', 'Older Women (WATER Study', '41 women (64.3 [3.1]\xa0y']","['continuous (CTG) and an interval (ITG) water-based aerobic training group', '2 water-based aerobic training programs', 'Water-Based Aerobic Training', 'Functional tests with and without dual-task and QoL questionnaire']","['6-minute walk', '30-second chair stand', 'functional capacity', 'Functional Capacity and Quality of Life Outcomes', 'gait velocity with verbal task', 'QoL perception', 'functional capacity and quality of life (QoL', 'physical domain of QoL', '5-m habitual gait velocity', '30-second chair stand test']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517683', 'cui_str': '3.1'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",41.0,0.0524121,"CONCLUSIONS


Both water-based aerobic training programs induced similar improvements in the functional capacity and maintained the QoL perception in older women.","[{'ForeName': 'Luana Siqueira', 'Initials': 'LS', 'LastName': 'Andrade', 'Affiliation': ''}, {'ForeName': 'Stephanie Santana', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'Mariana Ribeiro', 'Initials': 'MR', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Paula Carolini', 'Initials': 'PC', 'LastName': 'Campelo', 'Affiliation': ''}, {'ForeName': 'Samara Nickel', 'Initials': 'SN', 'LastName': 'Rodrigues', 'Affiliation': ''}, {'ForeName': 'Mariana Borba', 'Initials': 'MB', 'LastName': 'Gomes', 'Affiliation': ''}, {'ForeName': 'Vitor Lima', 'Initials': 'VL', 'LastName': 'Krüger', 'Affiliation': ''}, {'ForeName': 'Graciele Ferreira', 'Initials': 'GF', 'LastName': 'de Ferreira', 'Affiliation': ''}, {'ForeName': 'Cristine Lima', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0552']
2765,32668428,Efficacy of Various Corticosteroid Treatment Modalities for the Initial Treatment of Idiopathic Sudden Hearing Loss: A Prospective Randomized Controlled Trial.,"OBJECTIVE


To evaluate the efficacy of systemic and intratympanic steroid treatment in patients with idiopathic sudden sensorineural hearing loss (ISSNHL).
METHODS


Ninety patients who met the inclusion criteria were randomly divided into 3 groups (n = 30 per group). Group I patients were given oral methylprednisolone (MEPD) tablets, group II received intravenous MEPD injection, and group III received intratympanic MEPD injection. Pure-tone average (PTA) hearing threshold was recorded before and after treatment as well as 1 month later. The general efficacy rate was the ratio of patients whose hearing improved by >10 dB in each group.
RESULTS


Thirty-two of the 60 patients (53.3%) in groups I and II together showed a hearing improvement of >10 dB hearing level (HL) in the pure-tone audiogram, compared to 21 patients (70%) in group III, respectively. The mean improvements were 16.1, 14.3, and 21.6 dB HL measured in Groups I, II, and III, respectively. Both the general efficacy rate and hearing improvement were significantly greater in group III than in groups I and II.
CONCLUSIONS


Our study showed that intratympanic injection rendered better treatment efficacy than systemic administration.",2020,"I and II together showed a hearing improvement of >10 dB hearing level (HL) in the pure-tone audiogram, compared to 21 patients (70%) in group III, respectively.","['Ninety patients who met the inclusion criteria', 'Hearing Loss', 'Idiopathic Sudden', 'patients with idiopathic sudden sensorineural hearing loss (ISSNHL']","['Various Corticosteroid Treatment Modalities', 'intravenous MEPD injection, and group III received intratympanic MEPD injection', 'systemic and intratympanic steroid treatment', 'oral methylprednisolone (MEPD) tablets']","['Pure-tone average (PTA) hearing threshold', 'general efficacy rate and hearing improvement', 'hearing improvement of >10 dB hearing level (HL', 'general efficacy rate']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4084437', 'cui_str': 'Methylprednisolone Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0360556', 'cui_str': 'Methylprednisolone-containing product in oral dose form'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175841', 'cui_str': 'Hearing level'}]",90.0,0.0125677,"I and II together showed a hearing improvement of >10 dB hearing level (HL) in the pure-tone audiogram, compared to 21 patients (70%) in group III, respectively.","[{'ForeName': 'Busheng', 'Initials': 'B', 'LastName': 'Tong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Otolaryngology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Hellstrom', 'Affiliation': 'Division of Ear, Nose and Throat Patient Area, Trauma and Reparative Medicine Theme, Karolinska University Hospital, Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Maoli', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China, maoli.duan@ki.se.'}]",Audiology & neuro-otology,['10.1159/000508124']
2766,32668455,"Switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV.","BACKGROUND


Bictegravir/emtricitabine/and tenofovir alafenamide (B/F/TAF) is guideline-recommended treatment for HIV-1. We evaluated whether people receiving dolutegravir (DTG) plus F/TAF or F/tenofovir disoproxil fumarate (TDF) with viral suppression can switch to B/F/TAF without compromising safety or efficacy, regardless of pre-existing NRTI resistance.
METHODS


In this multicenter, randomized, double-blinded, active-controlled, noninferiority trial (ClinicalTrials.gov: NCT03110380), we enrolled virologically suppressed adults for ≥6 months before screening (with documented/suspected NRTI resistance) or ≥3 months before screening (with no documented/suspected NRTI resistance) on DTG plus either F/TDF or F/TAF. We randomly assigned (1:1) participants to switch to B/F/TAF or DTG+F/TAF once daily for 48 weeks, each with matching placebo. The primary endpoint was proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at week 48 (Snapshot algorithm); the pre-specified noninferiority margin was 4%.
FINDINGS


567 adults were randomized; 565 were treated (284 B/F/TAF, 281 DTG+F/TAF). At week 48, B/F/TAF was noninferior to DTG+F/TAF, as 0.4% (1/284) vs 1.1% (3/281) (difference -0.7%, 95.001% CI: -2.8% to 1.0%) had HIV-1 RNA ≥50 copies/mL. There were no significant differences in efficacy among participants with suspected or confirmed prior NRTI resistance (n=138). No participant had treatment-emergent drug resistance. Median weight change from baseline at week 48 was +1.3 kg (B/F/TAF) vs +1.1 kg (DTG+F/TAF) (p=0.46). Weight change differed by baseline NRTIs +2.2 kg (F/TDF) and +0.6 kg (F/TAF) (p<0.001), with no differences between B/F/TAF and DTG+F/TAF.
INTERPRETATION


The single-tablet regimen B/F/TAF is a safe, effective option for people virologically suppressed on DTG plus either F/TDF or F/TAF, including in individuals with pre-existing resistance to NRTIs.",2020,"At week 48, B/F/TAF was noninferior to DTG+F/TAF, as 0.4% (1/284) vs 1.1% (3/281) (difference -0.7%, 95.001% CI: -2.8% to 1.0%) had HIV-1 RNA ≥50 copies/mL.","['participants with suspected or confirmed prior NRTI resistance (n=138', '567 adults', 'enrolled virologically suppressed adults for ≥6 months before screening (with documented/suspected NRTI resistance) or ≥3 months before screening (with no documented/suspected NRTI resistance) on DTG plus either F/TDF or F/TAF', 'virologically suppressed adults with HIV']","['Bictegravir/emtricitabine/and tenofovir alafenamide (B/F/TAF', 'people receiving dolutegravir (DTG) plus F/TAF or F/tenofovir disoproxil fumarate (TDF', 'bictegravir, emtricitabine, and tenofovir alafenamide', 'TAF or DTG+F/TAF once daily for 48 weeks, each with matching placebo']","['Weight change', 'Median weight change', 'proportion of participants with plasma HIV-1 RNA ≥50 copies', 'treatment-emergent drug resistance']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance'}]",567.0,0.559929,"At week 48, B/F/TAF was noninferior to DTG+F/TAF, as 0.4% (1/284) vs 1.1% (3/281) (difference -0.7%, 95.001% CI: -2.8% to 1.0%) had HIV-1 RNA ≥50 copies/mL.","[{'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA, US.""}, {'ForeName': 'Jürgen K', 'Initials': 'JK', 'LastName': 'Rockstroh', 'Affiliation': 'University Hospital Bonn , Bonn, DE.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Luetkemeyer', 'Affiliation': 'University of California San Francisco, San Francisco, CA, US.'}, {'ForeName': 'Yazdan', 'Initials': 'Y', 'LastName': 'Yazdanpanah', 'Affiliation': 'Hôpital Bichat Claude Bernard, Paris, FR.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Dupont Circle Physicians, Washington D.C., US.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Trottier', 'Affiliation': 'Clinique de Medecine Urbaine du Quartier Latin, Montreal, Quebec, CA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Rieger', 'Affiliation': 'University of Vienna Medical School, Vienna, AT.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Gilead Sciences, Foster City, CA, US.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Gilead Sciences, Foster City, CA, US.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Gilead Sciences, Foster City, CA, US.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Foster City, CA, US.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Gilead Sciences, Foster City, CA, US.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa988']
2767,32668483,Platelet Inhibition with Ticagrelor versus Clopidogrel in Diabetic Patients after Percutaneous Coronary Intervention for Chronic Coronary Syndromes.,"BACKGROUND


Clopidogrel is currently the only P2Y 12  inhibitor with class I recommendation in patients after percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS). Diabetic patients have reduced therapeutic response to clopidogrel.
PURPOSE


This study assessed the antiplatelet effect of ticagrelor versus clopidogrel in diabetic patients after recent PCI for CCS.
METHODS


Eligible patients were randomly assigned to receive ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, in addition to aspirin 100 mg once daily for 15 days. P2Y 12  reaction unit (PRU) and percent inhibition were measured by VerifyNow P2Y 12  assay. High on-treatment platelet reactivity (HOPR) was defined as PRU > 208. Bleeding was assessed by the Platelet Inhibition and Patient Outcomes criteria. Cardiac ischemic events were evaluated as adverse events.
RESULTS


The baseline characteristics of the patients ( n  = 39) were well balanced between the two groups. Both before and 2 to 4 hours after the final study dose on day 15, PRU was lower (41.3 ± 35.8 vs. 192.6 ± 49.5,  p  < 0.001; 36.6 ± 25.8 vs. 187.6 ± 70.9,  p  < 0.001), percent inhibition was higher (83.0% [70.5%, 96.0%] vs. 16.0% [0%, 25.0%],  p  < 0.001; 85.0% [76.0%, 96.5%] vs. 25.0% [0%, 39.0%],  p  < 0.001), and HOPR occurred less frequently (0% [0/20] vs. 26.3% [5/19],  p  = 0.020; 0% [0/20] vs. 31.6% [6/19],  p  = 0.008) in the ticagrelor group ( n  = 20) compared with the clopidogrel group ( n  = 19). No major or minor bleeding, or serious adverse events occurred in both groups.
CONCLUSION


Ticagrelor achieved greater peak and trough platelet inhibition than did clopidogrel in diabetic patients after recent PCI for CCS, which suggests the potential use of ticagrelor in this clinical setting.",2020,"No major or minor bleeding, or serious adverse events occurred in both groups.
","['chronic coronary syndromes (CCS', 'Diabetic Patients after Percutaneous Coronary Intervention for Chronic Coronary Syndromes', 'Diabetic patients', 'diabetic patients after recent PCI for CCS', 'diabetic patients', 'Eligible patients']","['Ticagrelor', 'percutaneous coronary intervention (PCI', 'Clopidogrel', 'ticagrelor 90\u2009mg twice daily or clopidogrel 75\u2009mg once daily, in addition to aspirin', 'clopidogrel', 'ticagrelor']","['percent inhibition', 'Bleeding', 'No major or minor bleeding, or serious adverse events', 'Cardiac ischemic events', 'peak and trough platelet inhibition', 'P2Y 12  reaction unit (PRU) and percent inhibition', 'HOPR', 'Platelet Inhibition']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C1628982', 'cui_str': '% inhib'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",,0.0644685,"No major or minor bleeding, or serious adverse events occurred in both groups.
","[{'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Center, Fu-Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuyang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1713375']
2768,32668487,"Acupuncture for pain, mandibular function and oral health-related quality of life in patients with masticatory myofascial pain: A randomized controlled trial.","BACKGROUND


Masticatory myofascial pain is the most prevalent muscular temporomandibular disorder (TMD). It primarily affects masseter and temporal muscles. Several treatments, including acupuncture, have been recommended. However, systematic reviews have highlighted gaps in studies and absence of conclusive results.
OBJECTIVES


We performed a randomized controlled clinical trial to evaluate the effectiveness of acupuncture in improving pain, mandibular function, and oral health-related quality of life in women with masticatory myofascial pain.
METHODS


Thirty-six patients diagnosed with masticatory myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were divided into the following two groups: acupuncture or control (non-penetrating acupuncture).Treatment was performed weekly for 5 weeks, and pain, mandibular function, and oral health-related quality of life were evaluated one week before treatment, one week after treatment, and one month after treatment. Non-parametric and parametric tests were used for comparisons between times and treatment groups (significance level of p≤0.05).
RESULTS


The acupuncture group showed a significant reduction in pain (p≤0.01), which was not observed in the control group. Pain intensity was reduced by 61% and 84% at 1 week and 1 month after treatment, respectively. Both groups showed significant improvements in mandibular function and oral health-related quality of life over time (p≤0.01). Statistical analysis did not show a significant difference between the groups for any other evaluated outcome (p>0.05).
CONCLUSION


Although acupuncture was effective in pain reduction, nonspecific factors may have influenced mandibular function and oral health-related quality of life improvements in both groups, and this needs to be further addressed.",2020,"Statistical analysis did not show a significant difference between the groups for any other evaluated outcome (p>0.05).
","['patients with masticatory myofascial pain', 'Thirty-six patients diagnosed with masticatory myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD', 'women with masticatory myofascial pain']","['acupuncture', 'acupuncture or control (non-penetrating acupuncture).Treatment', 'Acupuncture']","['mandibular function and oral health-related quality of life over time (p≤0.01', 'pain, mandibular function and oral health-related quality of life', 'Pain intensity', 'pain, mandibular function, and oral health-related quality of life', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0207800', 'cui_str': 'monorden'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",36.0,0.175874,"Statistical analysis did not show a significant difference between the groups for any other evaluated outcome (p>0.05).
","[{'ForeName': 'Franklin Teixeira', 'Initials': 'FT', 'LastName': 'de Salles-Neto', 'Affiliation': 'Pathology Postgraduate Program, Faculty of Medicine, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Janice Simpson', 'Initials': 'JS', 'LastName': 'de Paula', 'Affiliation': 'Department of Social and Preventive Dentistry, Faculty of Dentistry, UFMG, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'João Gabriel', 'Initials': 'JG', 'LastName': 'de Azevedo José Romero', 'Affiliation': 'Pathology Postgraduate Program, Faculty of Medicine, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Camila Megale', 'Initials': 'CM', 'LastName': 'Almeida-Leite', 'Affiliation': 'Department of Morphology, Biological Sciences Institute, UFMG, Belo Horizonte, MG, Brazil.'}]",Journal of oral rehabilitation,['10.1111/joor.13055']
2769,32668499,"Evaluation of Botulium toxin type A for treating hypertrophic scars: A split-scar, double-blind randomized controlled trial.","BACKGROUND


Hypertrophic scars (HS) are a challenging disorder that mostly develops during wound healing process following skin injuries.
METHODS


A split-scar, double-blind randomized controlled trial was held to assess the safety and efficacy of botulinum toxin type A (BTA) injection in hypertrophic scars (HS). Thirty patients with old scars (range 1-15years) were treated, with sides randomized to receive treatment with either BTA or 0.9% normal saline once monthly for three consecutive months. Scars were assessed using the Vancouver scar scale (VSS) along with digital photograph standardization RESULTS: Twenty one subjects completed the study. The mean VSS score for the BTA-treated half of the scars decreased from 7.29±2.327 before injection to 5.33±2.41 following injection which was highly significant (p = 0.01). For the control half, the mean VSS decreased insignificantly from 7.29±2.327 before injection to 7.10±2.234 following injection (p = 0.104).
CONCLUSION


Clinical and cosmetic improvement was demonstrated significantly among the BTA treated group. BTA can be an additional and useful tool for improving scar outcomes.",2020,"For the control half, the mean VSS decreased insignificantly from 7.29±2.327 before injection to 7.10±2.234 following injection (p = 0.104).
","['hypertrophic scars (HS', 'Thirty patients with old scars (range 1-15years', ' Twenty one subjects completed the study', 'hypertrophic scars']","['botulinum toxin type A (BTA) injection', 'BTA', 'BTA or 0.9% normal saline', 'Botulium toxin type A']","['safety and efficacy', 'mean VSS score', 'Vancouver scar scale (VSS', 'mean VSS']","[{'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0445349', 'cui_str': 'Toxin typing'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.351475,"For the control half, the mean VSS decreased insignificantly from 7.29±2.327 before injection to 7.10±2.234 following injection (p = 0.104).
","[{'ForeName': 'Ahmad R', 'Initials': 'AR', 'LastName': 'Elshahed', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Al Azhar university, El-Khalifa, Egypt.'}, {'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Elmanzalawy', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Al Azhar university, El-Khalifa, Egypt.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Shehata', 'Affiliation': 'Department of Dermatology and Venereology, National Research Centre, Giza, Egypt.'}, {'ForeName': 'Mohamed L', 'Initials': 'ML', 'LastName': 'ElSaie', 'Affiliation': 'Department of Dermatology and Venereology, National Research Centre, Giza, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13627']
2770,31369961,"Does navigated patellar resurfacing in total knee arthroplasty result in proper bone cut, motion and clinical outcomes?","BACKGROUND


In total knee arthroplasty with patellar resurfacing, patellar bone preparation, component positioning and motion assessments are still not navigated. Only femoral/tibial component positioning is supported by computer-assistance. The aim of this study was to verify, in-vivo, whether knee surgical navigation extended to patellar resurfacing, by original instrumentation and procedures for patellar-based tracking, could achieve accurate patella preparation in terms of original thickness restoration, bone cut orientation, and normal knee motion.
METHODS


An additional navigation system for patellar data acquisition was used together with a standard navigation system for total knee arthroplasty in 20 patients. This supported the surgeon for patellar resurfacing via measurement of removed bone thickness, three-dimensional patellar cut orientations, and patello-femoral motion. Radiological and clinical examinations at 6 and 24-month follow-up were also performed.
FINDINGS


The medio-lateral patellar-bone cut orientation was respectively 0.5° (standard deviation: 3.0°) and 1.4° (1.7°) lateral tilt, as measured via navigation and post-operatively on the Merchant x-ray view. The cranio-caudal orientation was 3.8° (7.2°) of flexion. The thickness variation between patellar pre- and post-implantation was 0.2 (1.3) mm. Immediately after implantation, patello-femoral as well as tibio-femoral kinematics was within the normality. Good radiological and clinical examinations at 6 and 24-month follow-up were also observed.
INTERPRETATION


For the first time, the effect of patellar navigation for its resurfacing was assessed in-vivo during surgery, with very good results for thickness restoration, proper cut orientation, and normal knee motion. These results support the introduction of patella-related navigation-based surgical procedures for computer-assisted total knee arthroplasty.",2019,"This supported the surgeon for patellar resurfacing via measurement of removed bone thickness, three-dimensional patellar cut orientations, and patello-femoral motion.",['20 patients'],"['navigated patellar resurfacing', 'patellar resurfacing, patellar bone preparation, component positioning and motion assessments', 'patellar navigation', 'knee surgical navigation extended to patellar resurfacing, by original instrumentation and procedures for patellar-based tracking']","['thickness restoration, proper cut orientation, and normal knee motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0223890', 'cui_str': 'Structure of base of patella'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",20.0,0.0193413,"This supported the surgeon for patellar resurfacing via measurement of removed bone thickness, three-dimensional patellar cut orientations, and patello-femoral motion.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Belvedere', 'Affiliation': 'Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy. Electronic address: belvedere@ior.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ensini', 'Affiliation': 'Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy; Department of Orthopaedic Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Tamarri', 'Affiliation': 'Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': ""d'Amato"", 'Affiliation': 'Department of Orthopaedic Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Barbadoro', 'Affiliation': 'Department of Orthopaedic Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Feliciangeli', 'Affiliation': 'Department of Orthopaedic Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'Department of Orthopaedic Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Leardini', 'Affiliation': 'Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.07.026']
2771,31444036,Association of rs7688285 allelic variation coding for GLRB with fear reactivity and exposure-based therapy in patients with panic disorder and agoraphobia.,"The gene coding for glycine receptor β subunits (GLRB) has been found to be related to panic disorder and agoraphobia (PD/AG) and to be associated with altered insular BOLD activation during fear conditioning, as an intermediate phenotype of defensive system reactivity in healthy subjects. In a multicenter clinical trial on PD/AG patients we investigated in three sub-samples whether GLRB allelic variation (A/G; A-allele identified as «risk») in the single nucleotide polymorphism rs7688285 was associated with autonomic (behavioral avoidance test BAT; n = 267 patients) and neural (differential fear conditioning; n = 49 patients, n = 38 controls) measures, and furthermore with responding towards exposure-based cognitive behavioral therapy (CBT, n = 184 patients). An interaction of genotype with current PD/AG diagnosis (PD/AG vs. controls; fMRI data only) and their modification after CBT was tested as well. Exploratory fMRI results prior to CBT, revealed A-allele carriers irrespective of diagnostic status to show overall higher BOLD activation in the hippocampus, motor cortex (MC) and insula. Differential activation in the MC, anterior cingulate cortex (ACC) and insula was found in the interaction genotype X diagnosis. Differential activation in ACC and hippocampus was present in differential fear learning. ACC activation was modified after treatment, while no overall rs7688285 dependent effect on clinical outcomes was found. On the behavioral level, A-allele carriers showed pronounced fear reactivity prior to CBT which partially normalized afterwards. In sum, rs7688285 variation interacts in a complex manner with PD/AG on a functional systems level and might be involved in the development of PD/AG but not in their treatment.",2019,"Differential activation in the MC, anterior cingulate cortex (ACC) and insula was found in the interaction genotype X diagnosis.","['PD/AG patients we investigated in three sub-samples whether GLRB allelic variation (A/G; A-allele identified as «risk») in the single nucleotide polymorphism rs7688285 was associated with autonomic (behavioral avoidance test BAT; n\u202f=\u202f267 patients) and neural (differential fear conditioning; n\u202f=\u202f49 patients, n\u202f=\u202f38 controls) measures, and furthermore with responding towards exposure-based cognitive behavioral therapy (CBT, n\u202f=\u202f184 patients', 'patients with panic disorder and agoraphobia', 'healthy subjects']",['GLRB with fear reactivity and exposure-based therapy'],"['fear reactivity', 'ACC activation']","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0061605', 'cui_str': 'Glycine Receptors'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3875150', 'cui_str': 'Towards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0061605', 'cui_str': 'Glycine Receptors'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",267.0,0.0146047,"Differential activation in the MC, anterior cingulate cortex (ACC) and insula was found in the interaction genotype X diagnosis.","[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany; Center for Mind, Brain and Behavior (CMBB), University of Marburg and Justus Liebig University Giessen, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Institute of Psychology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany; Center for Mind, Brain and Behavior (CMBB), University of Marburg and Justus Liebig University Giessen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoefler', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Hamm', 'Affiliation': 'Institute of Psychology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Christiane A', 'Initials': 'CA', 'LastName': 'Pané-Farré', 'Affiliation': 'Institute of Psychology, University of Greifswald, Greifswald, Germany; Department of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Gerlach', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stroehle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gloster', 'Affiliation': 'Division of Clinical Psychology and Intervention Science, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lang', 'Affiliation': 'Christoph-Dornier-Stiftung für Klinische Psychologie, Bremen, Germany; Department of Clinical Psychology and Psychotherapy, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Helbig-Lang', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Fehm', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Pauli', 'Affiliation': 'Department of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany; Center for Mind, Brain and Behavior (CMBB), University of Marburg and Justus Liebig University Giessen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany; Center for Mind, Brain and Behavior (CMBB), University of Marburg and Justus Liebig University Giessen, Germany.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.07.133']
2772,31590154,Responsiveness to Resistance-Based Multimodal Exercise Among Men With Prostate Cancer Receiving Androgen Deprivation Therapy.,"BACKGROUND


Androgen deprivation therapy (ADT) in the management of prostate cancer (PCa) results in an array of adverse effects, and exercise is one strategy to counter treatment-related musculoskeletal toxicities. This study assessed the prevalence of exercise responsiveness in men with PCa undergoing ADT in terms of body composition, muscle strength, and physical function.
METHODS


Prospective analyses were performed in 152 men (aged 43-90 years) with PCa receiving ADT who were engaged in resistance exercise combined with aerobic or impact training for 3 to 6 months. Whole-body lean mass and fat mass (FM), trunk FM, and appendicular skeletal muscle were assessed with dual x-ray absorptiometry; upper and lower body muscle strength were assessed with the one-repetition maximum; and physical function was assessed with a battery of tests (6-m usual, fast, and backward walk; 400-m walk; repeated chair rise; stair climb).
RESULTS


Significant improvements were seen (P<.01) in lean mass (0.4±1.4 kg [range, -2.8 to +4.1 kg]), appendicular skeletal muscle (0.2±0.8 kg [range, -1.9 to +1.9 kg]), and all measures of muscle strength (chest press, 2.9±5.8 kg [range, -12.5 to +37.5 kg]; leg press, 29.2±27.6 kg [range, -50.0 to +140.0 kg]) and physical function (from -0.1±0.5 s [range, +1.3 to -2.1 s] for the 6-m walk; to -8.6±15.2 s [range, +25.2 to -69.7 s] for the 400-m walk). An increase in FM was also noted (0.6±1.8 kg [range, -3.6 to +7.3 kg]; P<.01). A total of 21 men did not exhibit a favorable response in at least one body composition component, 10 did not experience improved muscle strength, and 2 did not have improved physical function. However, all patients responded in at least one of the areas, and 120 (79%) favorably responded in all 3 areas.
CONCLUSIONS


Despite considerable heterogeneity, most men with PCa receiving ADT responded to resistance-based multimodal exercise, and therefore our findings indicate that this form of exercise can be confidently prescribed to produce beneficial effects during active treatment.",2019,"RESULTS


Significant improvements were seen (P<.01) in lean mass (0.4±1.4 kg [range, -2.8 to +4.1 kg]), appendicular skeletal muscle (0.2±0.8 kg [range, -1.9 to +1.9 kg]), and all measures of muscle strength (chest press, 2.9±5.8 kg [range, -12.5 to +37.5 kg]; leg press, 29.2±27.6 kg [range, -50.0 to +140.0 kg]) and physical function (from -0.1±0.5 s [range, +1.3 to -2.1 s] for the 6-m walk; to -8.6±15.2 s [range, +25.2 to -69.7 s] for the 400-m walk).","['men with PCa undergoing', '152 men (aged 43-90 years) with PCa receiving ADT who were engaged in', 'Men']","['Androgen deprivation therapy (ADT', 'ADT', 'resistance exercise combined with aerobic or impact training', 'Resistance-Based Multimodal Exercise', 'Prostate Cancer Receiving Androgen Deprivation Therapy']","['physical function', 'Whole-body lean mass and fat mass (FM), trunk FM, and appendicular skeletal muscle', 'lean mass', 'appendicular skeletal muscle', 'muscle strength', 'FM']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",152.0,0.0574033,"RESULTS


Significant improvements were seen (P<.01) in lean mass (0.4±1.4 kg [range, -2.8 to +4.1 kg]), appendicular skeletal muscle (0.2±0.8 kg [range, -1.9 to +1.9 kg]), and all measures of muscle strength (chest press, 2.9±5.8 kg [range, -12.5 to +37.5 kg]; leg press, 29.2±27.6 kg [range, -50.0 to +140.0 kg]) and physical function (from -0.1±0.5 s [range, +1.3 to -2.1 s] for the 6-m walk; to -8.6±15.2 s [range, +25.2 to -69.7 s] for the 400-m walk).","[{'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Taaffe', 'Affiliation': 'Exercise Medicine Research Institute, and.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, and.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Exercise Medicine Research Institute, and.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'Exercise Medicine Research Institute, and.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Galvão', 'Affiliation': 'Exercise Medicine Research Institute, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2019.7311']
2773,31790983,Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial.,"Minimal residual disease (MRD) negativity is a key prognostic indicator of outcome in acute lymphocytic leukemia. In the INO-VATE trial (clinicaltrials.gov identifier: NCT01564784), patients with relapsed/refractory acute lymphocytic leukemia who received inotuzumab versus standard chemotherapy achieved greater remission and MRD-negativity rates as well as improved overall survival: hazard ratio 0.75, one-sided P = 0.0105. The current analysis assessed the prognostic value of MRD negativity at the end of inotuzumab treatment. All patients who received inotuzumab (n = 164) were included. Among patients with complete remission/complete remission with incomplete hematologic response (CR/CRi; n = 121), MRD-negative status (by multiparametric flow cytometry) was defined as <1 × 10 -4  blasts/nucleated cells. MRD negativity was achieved in 76 patients at the end of treatment. Compared with MRD-positive, MRD-negative status with CR/CRi was associated with significantly improved overall survival and progression-free survival, respectively: hazard ratio (97.5% confidence interval; one-sided P-value) 0.512 (97.5% CI [0.313-0.835]; P = 0.0009) and 0.423 (97.5% CI [0.256-0.699]; P < 0.0001). Median overall survival was 14.1 versus 7.2 months, in the MRD-negative versus MRD-positive groups. Patients in first salvage who achieved MRD negativity at the end of treatment experienced significantly improved survival versus that seen in MRD-positive patients, particularly for those patients who proceeded to stem cell transplant. Among patients with relapsed/refractory acute lymphocytic leukemia who received inotuzumab, those with MRD-negative CR/CRi had the best survival outcomes.",2020,"Compared with MRD-positive, MRD-negative status with CR/CRi was associated with significantly improved overall survival and progression-free survival, respectively: hazard ratio (97.5% confidence interval; one-sided P-value) 0.512 (97.5% CI [0.313-0.835]; P = 0.0009) and 0.423 (97.5% CI [0.256-0.699]; P < 0.0001).","['patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial', 'All patients who received inotuzumab (n = 164) were included', 'patients with relapsed/refractory acute lymphocytic leukemia who received', 'acute lymphocytic leukemia', 'patients with relapsed/refractory acute lymphocytic leukemia']",['inotuzumab versus standard chemotherapy'],"['Median overall survival', 'survival outcomes', 'remission and MRD-negativity rates', 'overall survival', 'survival', 'MRD-negative status', 'Minimal residual disease (MRD) negativity', 'MRD negativity', 'complete remission/complete remission with incomplete hematologic response', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",164.0,0.100696,"Compared with MRD-positive, MRD-negative status with CR/CRi was associated with significantly improved overall survival and progression-free survival, respectively: hazard ratio (97.5% confidence interval; one-sided P-value) 0.512 (97.5% CI [0.313-0.835]; P = 0.0009) and 0.423 (97.5% CI [0.256-0.699]; P < 0.0001).","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ejabbour@mdanderson.org.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gökbuget', 'Affiliation': 'Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Advani', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Universitätsklinikum Münster, Germany.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Liedtke', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori (IRST) IRCCS, Meldola, FC, Italy.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'A Douglas', 'Initials': 'AD', 'LastName': 'Laird', 'Affiliation': 'Pfizer Inc, San Francisco, CA, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vandendries', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Neuhof', 'Affiliation': 'Pfizer Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Nguyen', 'Affiliation': 'Navigate BioPharma Services, Inc, a Novartis Subsidiary, Carlsbad, CA, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Dakappagari', 'Affiliation': 'Navigate BioPharma Services, Inc, a Novartis Subsidiary, Carlsbad, CA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeAngelo', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Leukemia research,['10.1016/j.leukres.2019.106283']
2774,32669178,[Efficiency of heart rate and heart rate difference at different time points during head-up tilt test in the diagnosis of postural tachycardia syndrome in children and adolescents].,"OBJECTIVE


To study the efficiency of heart rate (HR) and heart rate difference (HRD) at different time points during head-up tilt test (HUTT) in the diagnosis of postural tachycardia syndrome (POTS) in children and adolescents.
METHODS


A total of 217 children and adolescents, aged 6-16 years, who were diagnosed with POTS were enrolled as the POTS group, and 73 healthy children and adolescents, matched for sex and age, were enrolled as the control group. The POTS group was further divided into ≤12 years old group with 127 children/adolescents and >12 years old group with 90 children/adolescents. The two groups were compared in terms of HR at baseline and at 5 and 10 minutes of HUTT (HR0, HR5, and HR10 respectively), difference between HR5/HR10 and HR0 (HRD5 and HRD10 respectively). The efficiency of HR5, HR10, HRD5 and HRD10 in the diagnosis of POTS was assessed.
RESULTS


Compared with the control group, the POTS group had significant increases in HR5, HR10, HRD5, and HRD10 (P<0.05). The coincidence rate of HR or HRD for the diagnosis of POTS in males was higher than that in females at 5 minutes of HUTT (P<0.05), while the coincidence rate of HR or HRD for the diagnosis of POTS in males was lower than that in females at 10 minutes of HUTT (P<0.05). The coincidence rate of HR for the diagnosis of POTS was higher in the >12 years old subgroup (P<0.05), while the coincidence rate of HRD for the diagnosis of POTS was higher in the ≤12 years old subgroup (P<0.05). The combination of HR5, HR10, HRD5, and HRD10 for the diagnosis of POTS had a greater area under the curve (0.974; 95%CI: 0.949-0.989) than HR5, HR10, HRD5, or HRD10 alone, with a sensitivity of 87.80% and a specificity of 95.83%. The diagnostic efficacy of HRD for POTS was higher than that of HR (P<0.05).
CONCLUSIONS


HR and HRD at different time points during HUTT have a good value in the diagnosis of POTS in children and adolescents, and the accuracy of diagnosis varies with age and gender.",2020,"Compared with the control group, the POTS group had significant increases in HR5, HR10, HRD5, and HRD10 (P<0.05).","['≤12 years old group with 127 children/adolescents and >12 years old group with 90 children/adolescents', '217 children and adolescents, aged 6-16 years, who were diagnosed with POTS were enrolled as the POTS group, and 73 healthy children and adolescents, matched for sex and age, were enrolled as the control group', 'children and adolescents']",['head-up tilt test (HUTT'],"['efficiency of HR5, HR10, HRD5 and HRD10 in the diagnosis of POTS', 'HR5, HR10, HRD5, and HRD10 (P<0.05', 'coincidence rate of HR or HRD', 'coincidence rate of HR for the diagnosis of POTS', 'HR5/HR10 and HR0 (HRD5 and HRD10 respectively', 'efficiency of heart rate (HR) and heart rate difference (HRD', 'HR5, HR10, HRD5, and HRD10', 'Efficiency of heart rate and heart rate difference', 'postural tachycardia syndrome', 'postural tachycardia syndrome (POTS', 'diagnostic efficacy of HRD for POTS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0242880', 'cui_str': 'Tilt table test'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",217.0,0.0317252,"Compared with the control group, the POTS group had significant increases in HR5, HR10, HRD5, and HRD10 (P<0.05).","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatric Cardiovasology, Children's Medical Center, Second Xiangya Hospital, Central South University, Changsha 410011, China. wangcheng2nd@csu.edu.cn.""}, {'ForeName': 'Run-Mei', 'Initials': 'RM', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Yi-Yi', 'Initials': 'YY', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Hai-Hui', 'Initials': 'HH', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yu-Wen', 'Initials': 'YW', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2775,32669215,Effect of Puppet Show on Children's anxiety and pain levels during the circumcision operation: A randomized controlled trial.,"INTRODUCTION


Surgical procedures are the most common causes of anxiety and pain in hospitalized children. One of the most common surgical procedures for children is circumcision. Surgical procedures such as circumcision in hospitals are the most common causes of pain, fear, and anxiety in children. Therapeutic play methods as non-pharmacological applications are being developed recently for children who use analgesics in the treatment of pain and anxiety. Nurses can use the game in three areas such as a care strategy for hospitalized children during daily routine practices, surgery, and invasive or painful treatment procedures. An extensive literature review revealed that there were therapeutic game plays performed before and after the surgical procedure. Nonetheless, no therapeutic game play performed during the surgical procedure were reported. In addition, no reported study of puppet show which is one of the therapeutic game methods were found.
OBJECTIVE


The aim of this study was to investigate the effect of the puppet show demonstrated to 7-11 years old children during circumcision on the anxiety and pain level of children.
DESIGN


The study was designed as a randomized controlled experiment.
MATERIALS AND METHODS


The population of the study was the children between 7 and 11 years of old and being circumcised in the urology clinic at Research and Training Hospital in Karabük Turkey between 1 May and 1 September 2017. A total of 81 (experimental group: 40, control group: 41) children were included in the study. ""Participant Information Form"", ""Wong Baker Faces Pain Rating Scale"" and ""State-Trait Anxiety Inventory for Children"" were used as implemented in the literature.
RESULTS


The median pain score of the experimental group during and after the procedure was statistically lower than the control group. The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure. In the control group, while the level of anxiety during the procedure showed a statistically significant increase compared to the pre-treatment level, the level of anxiety after the procedure showed a statistically significant decrease compared to the one during the procedure.
CONCLUSION


It was concluded that the puppet show performed during the circumcision procedure was effective in reducing the pain and anxiety that developed during the circumcision and continued after the procedure.",2020,The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure.,"['children between 7 and 11 years of old and being circumcised in the urology clinic at Research and Training Hospital in Karabük Turkey between 1 May and 1 September 2017', 'hospitalized children during daily routine practices, surgery, and invasive or painful treatment procedures', '7-11 years old children during circumcision on the anxiety and pain level of children', 'hospitalized children', 'children who use analgesics in the treatment of pain and anxiety', 'A total of 81 (experimental group: 40, control group: 41) children were included in the study. ']",['Puppet'],"['median pain score', 'level of anxiety', ""Children's anxiety and pain levels"", 'Participant Information Form"", ""Wong Baker Faces Pain Rating Scale"" and ""State-Trait Anxiety Inventory', 'pain and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034125', 'cui_str': 'Puppets'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0332306,The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure.,"[{'ForeName': 'Özge Karakaya', 'Initials': 'ÖK', 'LastName': 'Suzan', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, University of Sakarya, Esentepe Campus, 54187, Turkey. Electronic address: ozgekarakayasuzan@sakarya.edu.tr.'}, {'ForeName': 'Özlem Öztürk', 'Initials': 'ÖÖ', 'LastName': 'Şahin', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Karabuk University, Demir-Celik Kampusu, 78050, Karabuk, Turkey. Electronic address: zlemzturk@hotmail.com.'}, {'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Baran', 'Affiliation': 'Department of Urology, Faculty of Medical, Karabuk University, Demir-Celik Kampusu, 78050, Karabuk, Turkey. Electronic address: ozerbaran@karabuk.edu.tr.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.06.016']
2776,32669217,A four week trial of hypertonic saline in children with mild cystic fibrosis lung disease: Effect on mucociliary clearance and clinical outcomes.,"BACKGROUND


Hypertonic saline (HS) is commonly prescribed for children with cystic fibrosis (CF) despite the absence of strong data indicating clinical efficacy in a population with mild lung disease. We hypothesized that HS treatment would result in a sustained improvement in mucociliary clearance (MCC) in children with CF who had minimal lung disease, thus providing evidence for a biologically relevant effect that also may be associated with clinical improvements.
METHODS


We performed a randomized, placebo controlled, double blind study of 6% versus 0.12% sodium chloride, delivered three-times daily with an eFlow nebulizer for 4 weeks. MCC was measured using gamma scintigraphy at baseline, 2-hours after the first study treatment, and ~12-hours after the final dose (at day 28). Spirometry, respiratory symptoms (CFQ-R), and safety were also assessed.
RESULTS


Study treatments were generally well tolerated and safe. HS (6% sodium chloride) resulted in a significant, sustained improvement from baseline in whole lung clearance after 4 weeks of therapy (p = 0.014), despite absence of a prolonged single-dose effect after the initial dose. This sustained change (12 hrs after prior dose) was significantly greater when compared to placebo (0.12% sodium chloride) treatment (p = 0.016). Improvements in spirometry with HS did not reach statistical significance but correlated with MCC changes.
CONCLUSIONS


The observed sustained improvement in MCC with HS suggests that this treatment may yield health benefits, even in relatively mildly affected children with CF. Highlighting this physiologic finding is important due to the lack of meaningful, validated endpoints in this population.",2020,"HS (6% sodium chloride) resulted in a significant, sustained improvement from baseline in whole lung clearance after 4 weeks of therapy (p = 0.014), despite absence of a prolonged single-dose effect after the initial dose.","['children with cystic fibrosis (CF', 'children with CF who had minimal lung disease', 'children with mild cystic fibrosis lung disease']","['sodium chloride', 'HS', 'Hypertonic saline (HS', 'HS (6% sodium chloride', 'hypertonic saline', 'sodium chloride) treatment ', 'placebo']","['whole lung clearance', 'mucociliary clearance (MCC', 'tolerated and safe', 'MCC', 'Spirometry, respiratory symptoms (CFQ-R), and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0392164', 'cui_str': 'Cystic fibrosis of the lung'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.41655,"HS (6% sodium chloride) resulted in a significant, sustained improvement from baseline in whole lung clearance after 4 weeks of therapy (p = 0.014), despite absence of a prolonged single-dose effect after the initial dose.","[{'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Donaldson', 'Affiliation': 'University of North Carolina School of Medicine at Chapel Hill, NC, Pulmonary and Critical Care Medicine, Chapel Hill, USA. Electronic address: scott_donaldson@med.unc.edu.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Danielle Samulski', 'Affiliation': 'University of North Carolina School of Medicine at Chapel Hill, NC, Pulmonary and Critical Care Medicine, Chapel Hill, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'LaFave', 'Affiliation': 'University of North Carolina School of Medicine at Chapel Hill, NC, Pulmonary and Critical Care Medicine, Chapel Hill, USA; Department of Pediatrics, Chapel Hill, USA.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Zeman', 'Affiliation': 'Center for Environmental Medicine, Asthma and Lung Biology, Chapel Hill, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Center for Environmental Medicine, Asthma and Lung Biology, Chapel Hill, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Trimble', 'Affiliation': 'University of North Carolina School of Medicine at Chapel Hill, NC, Pulmonary and Critical Care Medicine, Chapel Hill, USA.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Ceppe', 'Affiliation': 'University of North Carolina School of Medicine at Chapel Hill, NC, Pulmonary and Critical Care Medicine, Chapel Hill, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Bennett', 'Affiliation': 'University of North Carolina School of Medicine at Chapel Hill, NC, Pulmonary and Critical Care Medicine, Chapel Hill, USA; Center for Environmental Medicine, Asthma and Lung Biology, Chapel Hill, USA.'}, {'ForeName': 'Stephanie D', 'Initials': 'SD', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, Chapel Hill, USA.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.07.009']
2777,32669232,Tuning consciousness: Anesthetic-sparing effect of varying sound on sedative anesthesia.,"This study aimed to identify the anesthetic-sparing effect of different intraoperative sound on sedated patients under propofol target controlled infusion anesthesia (TCI). 90 patients scheduled for transvaginal oocyte retrieval surgery (TVOR) were available and randomized into three groups: patients isolated from background noise(S), patients listened to a voice calling their names (CN), or patients listened to the classical music (CM). The main outcome was the value of total propofol consumption/surgical time. In the result, the value of total propofol consumption/surgical time for the CM group was 22.48% lower than CN group. The value of ΔEntropy and ΔCE for the CM group were also lower than that for the CN group (-2.17 ± 4.13 vs. 1.33 ± 3.43, P-value<0.001) (-0.17 ± 0.28 vs. 0.07 ± 0.25, P-value<0.001). We concluded that participants under propofol TCI who were listening to classical music had lower CE value, Entropy level and reduced 22.48% total propofol consumption/surgical time compared to those called by their names.",2020,"The value of ΔEntropy and ΔCE for the CM group were also lower than that for the CN group (-2.17 ± 4.13 vs. 1.33 ± 3.43, P-value<0.001)","['participants under', 'sedated patients under', '90 patients scheduled for']","['transvaginal oocyte retrieval surgery (TVOR', 'patients listened to a voice calling their names (CN), or patients listened to the classical music (CM', 'propofol target controlled infusion anesthesia (TCI', 'propofol TCI', 'sedative anesthesia']","['CE value, Entropy level', 'value of total propofol consumption/surgical time', 'value of ΔEntropy and ΔCE', 'total propofol consumption/surgical time']","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3163670', 'cui_str': 'Target controlled total intravenous anesthesia'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",90.0,0.0168795,"The value of ΔEntropy and ΔCE for the CM group were also lower than that for the CN group (-2.17 ± 4.13 vs. 1.33 ± 3.43, P-value<0.001)","[{'ForeName': 'Ching Hao', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Yi Jer', 'Initials': 'YJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Anesthesiology, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Yu Jun', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Epidemiology and Biostatistics Center, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Chih Kai', 'Initials': 'CK', 'LastName': 'Shih', 'Affiliation': 'Department of Anesthesiology, Changhua Christian Hospital, Changhua, Taiwan. Electronic address: 168568@cch.org.tw.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2020.07.010']
2778,31623511,Women of Reproductive Age Living with HIV in Argentina: Unique Challenges for Reengagement in Care.,"This study evaluated the reasons for not taking antiretroviral treatment (ART) among women of reproductive age who are disengaged from HIV care (have missed pharmacy pickups and physician visits), with the goal of identifying strategies for reengagement in HIV care. Participants were cisgender women (n = 162), 18 to 49 years of age, and who completed sociodemographic, medical history, reasons why they were not taking ART, mental health, motivation, and self-efficacy assessments. Latent class analysis was used for analysis. Women who reported avoidance-based coping (avoid thinking about HIV) had higher depression ( U  = 608.5,  z  = -2.7,  P  = .007), lower motivation ( U  = 601,  z  = -2.8,  P  = .006), and lower self-efficacy ( U  = 644.5,  z  = -2.4,  P  = .017) than those not using this maladaptive strategy. As women living with HIV experience a disproportionate burden of poor health outcomes, interventions focused on the management of depression may improve HIV outcomes and prevent HIV transmission.",2019,"Women who reported avoidance-based coping (avoid thinking about HIV) had higher depression ( U  = 608.5,  z  = -2.7,  P  = .007), lower motivation ( U  = 601,  z  = -2.8,  P  = .006), and lower self-efficacy ( U  = 644.5,  z  = -2.4,  P  = .017) than those not using this maladaptive strategy.","['women living with HIV experience', 'Women of Reproductive Age Living with HIV in Argentina', 'women of reproductive age who are disengaged from HIV care (have missed pharmacy pickups and physician visits', 'Participants were cisgender women (n = 162), 18 to 49 years of age, and who completed sociodemographic, medical history, reasons why they were not taking ART, mental health, motivation, and self-efficacy assessments']",[],"['HIV outcomes and prevent HIV transmission', 'self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0787983,"Women who reported avoidance-based coping (avoid thinking about HIV) had higher depression ( U  = 608.5,  z  = -2.7,  P  = .007), lower motivation ( U  = 601,  z  = -2.8,  P  = .006), and lower self-efficacy ( U  = 644.5,  z  = -2.4,  P  = .017) than those not using this maladaptive strategy.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cecchini', 'Affiliation': 'Helios Salud, Buenos Aires, Argentina.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Alcaide', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Violeta de Jesus', 'Initials': 'VJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Lissa Nicole', 'Initials': 'LN', 'LastName': 'Mandell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'John Michael', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Cassetti', 'Affiliation': 'Helios Salud, Buenos Aires, Argentina.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Sued', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Stephen Marshall', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Deborah Lynne', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Journal of the International Association of Providers of AIDS Care,['10.1177/2325958219883250']
2779,32669306,Effects of Intensive Blood Pressure Control in Patients with and without Albuminuria:  Post Hoc  Analyses from SPRINT.,"BACKGROUND AND OBJECTIVES


It is unclear whether the presence of albuminuria modifies the effects of intensive systolic BP control on risk of eGFR decline, cardiovascular events, or mortality.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


The Systolic Blood Pressure Intervention Trial randomized nondiabetic adults ≥50 years of age at high cardiovascular risk to a systolic BP target of <120 or <140 mm Hg, measured by automated office BP. We compared the absolute risk differences and hazard ratios of ≥40% eGFR decline, the Systolic Blood Pressure Intervention Trial primary cardiovascular composite outcome, and all-cause death in those with or without baseline albuminuria (urine albumin-creatinine ratio ≥30 mg/g).
RESULTS


Over a median follow-up of 3.1 years, 69 of 1723 (4%) participants with baseline albuminuria developed ≥40% eGFR decline compared with 61 of 7162 (1%) participants without albuminuria. Incidence rates of ≥40% eGFR decline were higher in participants with albuminuria (intensive, 1.74 per 100 person-years; standard, 1.17 per 100 person-years) than in participants without albuminuria (intensive, 0.48 per 100 person-years; standard, 0.11 per 100 person-years). Although effects of intensive BP lowering on ≥40% eGFR decline varied by albuminuria on the relative scale (hazard ratio, 1.48; 95% confidence interval, 0.91 to 2.39 for albumin-creatinine ratio ≥30 mg/g; hazard ratio, 4.55; 95% confidence interval, 2.37 to 8.75 for albumin-creatinine ratio <30 mg/g;  P  value for interaction <0.001), the absolute increase in ≥40% eGFR decline did not differ by baseline albuminuria (incidence difference, 0.38 events per 100 person-years for albumin-creatinine ratio ≥30 mg/g; incidence difference, 0.58 events per 100 person-years for albumin-creatinine ratio <30 mg/g;  P  value for interaction =0.60). Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
CONCLUSIONS


Albuminuria did not modify the absolute benefits and risks of intensive systolic BP lowering.",2020,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","['nondiabetic adults ≥50 years of age at high cardiovascular risk to a systolic BP target of <120 or <140 mm Hg, measured by automated office BP', 'Patients with and without Albuminuria', 'participants with albuminuria (intensive, 1.74 per 100 person-years; standard, 1.17 per 100 person-years) than in participants without albuminuria (intensive, 0.48 per 100 person-years; standard, 0.11 per 100 person-years']",['Intensive Blood Pressure Control'],"['eGFR decline, cardiovascular events, or mortality', 'Incidence rates of ≥40% eGFR decline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C4517425', 'cui_str': '0.11'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.459874,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","[{'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Kidney Health Research Institute, Department of Population Health Sciences, Geisinger Health System, Danville, Pennsylvania achang@geisinger.edu.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Kramer', 'Affiliation': 'Division of Nephrology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Morgan E', 'Initials': 'ME', 'LastName': 'Grams', 'Affiliation': 'Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Public Health, University of Massachusetts-Lowell, Lowell, Massachusetts.'}, {'ForeName': 'Udayan', 'Initials': 'U', 'LastName': 'Bhatt', 'Affiliation': 'Division of Nephrology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Renal Division, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drawz', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension and Metabolic Research Institute, Carollton, Texas.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Amret', 'Initials': 'A', 'LastName': 'Hawfield', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horwitz', 'Affiliation': 'Division of Nephrology, MetroHealth Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McLouth', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Morisky', 'Affiliation': 'Department of Community Health Sciences, University of California, Los Angeles Fielding School of Public Health, Los Angeles, California.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'Department of Cardiology, Veterans Affairs Medical Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Wall', 'Affiliation': 'Division of Nephrology, Veterans Affairs Medical Center, Memphis, Tennessee.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Zias', 'Affiliation': 'Stony Brook University School of Medicine, Stony Brook, New York.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.12371019']
2780,32669375,Ganetespib in combination with pemetrexed-platinum chemotherapy in patients with pleural Mesothelioma (MESO-02): A phase Ib trial.,"PURPOSE


Ganetespib, a highly potent, small molecule Heatshock protein 90 inhibitor, has potential efficacy in malignant pleural mesothelioma (MPM) via activity on critical survival pathways and known synergies with antifolates and platinum chemotherapy. We conducted a dose-escalation study to identify the Maximum Tolerated Dose (MTD) of ganetespib in chemotherapy-naïve MPM patients.
EXPERIMENTAL DESIGN


MESO-02 (ClinicalTrials.gov: NCT01590160) was a non-randomized, multicentre, phase Ib trial of 3-weekly ganetespib (100 mg/m2, 150 mg/m2, 200 mg/m2; days 1 and 15) with pemetrexed (500 mg/m2; day 1) and cisplatin (75 mg/m2; day 1) or carboplatin (area under concentration-time curve 5; day 1) in MPM patients. Dose-escalation was performed using the 3+3 design (cisplatin) and accelerated titration design (carboplatin). Secondary endpoints included best response, progression-free survival (PFS) and pharmacogenomic analyses.
RESULTS


Of 27 patients enroled (cisplatin, n=16; carboplatin, n=11), 3 experienced dose-limiting toxicities: grade 3 nausea (cisplatin, n=1; carboplatin, n=1); grade 2 infusion-related reaction (carboplatin, n=1). Ganetespib's MTD was 200 mg/m2. Partial response was observed in 14/27 patients (52%; 61% in 23 response-evaluable patients) and 13/21 (62%) with epithelioid histology. At the MTD, 10/18 patients (56%) had partial response, 15/18 (83%) had disease control, and median PFS was 6.3 months (95% CI 5.0-10.0). One responder exhibited disease control beyond 50 months. Global Loss of Heterozygosity was associated with shorter time to progression (Hazard Ratio 1.12, 95% CI 1.02-1.24; p=0.018).
CONCLUSIONS


Ganetespib can be combined safely with pemetrexed and platinum chemotherapy to treat patients with MPM. This class of agent should be investigated in larger randomized studies.",2020,Partial response was observed in 14/27 patients (52%; 61% in 23 response-evaluable patients) and 13/21 (62%) with epithelioid histology.,"['27 patients enroled (cisplatin, n=16; carboplatin, n=11), 3 experienced dose-limiting toxicities: grade 3 nausea (cisplatin, n=1; carboplatin, n=1); grade 2 infusion-related reaction (carboplatin, n=1', 'patients with MPM', 'patients with pleural Mesothelioma (MESO-02', 'chemotherapy-naïve MPM patients']","['pemetrexed and platinum chemotherapy', 'carboplatin', '3+3 design (cisplatin) and accelerated titration design (carboplatin', 'cisplatin', 'Ganetespib in combination with pemetrexed-platinum chemotherapy', 'ganetespib', 'pemetrexed']","['best response, progression-free survival (PFS) and pharmacogenomic analyses', 'Partial response', 'Global Loss of Heterozygosity', 'partial response', 'disease control, and median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4084975', 'cui_str': 'Pharmacogenetic Study'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0524869', 'cui_str': 'Heterozygosity, Loss of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.15707,Partial response was observed in 14/27 patients (52%; 61% in 23 response-evaluable patients) and 13/21 (62%) with epithelioid histology.,"[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Mesothelioma Research Programme, Centre for Cancer Research, University of Leicester & University Hospitals of Leicester df132@leicester.ac.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': 'Department of Oncology & Metabolism, University of Sheffield, Sheffield Experimental Cancer Medicine Centre, Weston Park Hospital.'}, {'ForeName': 'Penella J', 'Initials': 'PJ', 'LastName': 'Woll', 'Affiliation': 'Academic Unit of Clinical Oncology, University of Sheffield.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Forster', 'Affiliation': 'CRUK Lung Cancer Centre of Excellence, University College London Hospitals NHS Foundation Trust.'}, {'ForeName': 'Denis C', 'Initials': 'DC', 'LastName': 'Talbot', 'Affiliation': 'Oncology, University of Oxford.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Child', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Farrelly', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London.'}, {'ForeName': 'Annabel J', 'Initials': 'AJ', 'LastName': 'Sharkey', 'Affiliation': 'CRUK Leicester Centre, Department of Cancer studies, University of Leicester.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Busacca', 'Affiliation': 'University of Leicester.'}, {'ForeName': 'Yenting', 'Initials': 'Y', 'LastName': 'Ngai', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Univseristy College London.'}, {'ForeName': 'Graham M', 'Initials': 'GM', 'LastName': 'Wheeler', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1306']
2781,32669656,"Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20 +  B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study.","This multicenter, randomized, double-blind, parallel-controlled trial aimed to compare the pharmacokinetics (PK) of IBI301 with rituximab in patients with CD20-positive (CD20 + ) B-cell lymphoma, who achieved a complete response/unconfirmed complete response after standard treatments. Patients were randomized (1:1) to receive IBI301 or rituximab (375 mg/m 2 , IV). Patients who continuously benefitted from the trial after the PK phase underwent the extension phase to receive up to three cycles of 3-month-cycle of rituximab/IBI301 maintenance therapy. PK was described using the area under the serum concentration-time curve from time zero to infinity (AUC 0-inf ), AUC from time zero to last quantifiable concentration (AUC 0-t ), and maximum serum concentration (C max ). Pharmacodynamics (PD), incidence of adverse events and immunogenicity were evaluated. PK was defined equivalent, if 90% confidence intervals (CIs) for geometric mean ratios of PK endpoints fell within the margin of 0.8-1.25. Overall, 181 patients were enrolled in IBI301 (n = 89) and rituximab (n = 92) groups. Geometric mean ratios of AUC 0-inf , AUC 0-t , and C max  were 0.91 (90% CI 0.85, 0.97), 0.91 (90% CI 0.86, 0.97), and 0.96 (90% CI 0.92, 1.01) between treatment groups, all within the bioequivalence range. Peripheral CD19 +  and CD20 +  B-cell counts were similar at each prespecified time point between the groups. No difference in immunogenicity was observed. The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab). IBI301 was PK bioequivalent to rituximab in patients with CD20 +  B-cell lymphoma. The PD, safety, and immunogenicity profiles of IBI301 were similar to those of rituximab.",2020,The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab).,"['patients with CD20 +  B-cell lymphoma', 'patients with CD20-positive (CD20 + ) B-cell lymphoma', '181 patients were enrolled in IBI301 (n\u2009=\u200989) and rituximab (n\u2009=\u200992) groups']","['rituximab/IBI301 maintenance therapy', 'IBI301 with rituximab', 'IBI301 or rituximab', 'IBI301 versus rituximab', 'rituximab']","['immunogenicity', 'incidences of treatment-emergent adverse events', 'PD, safety, and immunogenicity profiles of IBI301', 'Geometric mean ratios of AUC 0-inf , AUC 0-t , and C max', 'Peripheral CD19 +  and CD20 +  B-cell counts', 'Pharmacodynamics (PD), incidence of adverse events and immunogenicity', 'maximum serum concentration (C max ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",181.0,0.268598,The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab).,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ke', 'Affiliation': 'Hematology Department, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, The Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Hematology Department, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Lymphoma/Head and Neck Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Hematology Department, West China Hospital Sichuan University, Chengdu, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, The First Affiliated Hospital of Zhengzhou Medical University, Zhengzhou, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Oncology Department, Tianjin Union Medical Center Nankai University Affiliated Hospital, Tianjin, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Forth Medical Department, The Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Hematology Department, Tangdu Hospital, The Medical University of Air Forces, Xi'an, China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Bone Marrow Transplantation Center, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xielan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Hematology Department, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hematology Department, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Hematology Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Junyuan', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Lugui', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. qiulg@ihcams.ac.cn.'}]",Scientific reports,['10.1038/s41598-020-68360-0']
2782,32669672,"The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer.","BACKGROUND


There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer.
METHODS


The cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years' median follow-up. Prostate cancer resource-use collected from hospital records and trial participants was valued using UK reference-costs. QALYs (quality-adjusted-life-years) were calculated from patient-reported EQ-5D-3L measurements. Adjusted mean costs, QALYs, and incremental cost-effectiveness ratios were calculated; cost-effectiveness acceptability curves and sensitivity analyses addressed uncertainty; subgroup analyses considered age and disease-risk.
RESULTS


Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery). Active monitoring had lower adjusted mean costs (£5913) than radiotherapy (£7361) and surgery (£7519). Radiotherapy was the most likely (58% probability) cost-effective option at the UK NICE willingness-to-pay threshold (£20,000 per QALY). Subgroup analyses confirmed radiotherapy was cost-effective for older men and intermediate/high-risk disease groups; active monitoring was more likely to be the cost-effective option for younger men and low-risk groups.
CONCLUSIONS


Longer follow-up and modelling are required to determine the most cost-effective treatment for localised prostate cancer over a man's lifetime.
TRIAL REGISTRATION


Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).",2020,"Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery).",['prostate cancer'],"['active monitoring, surgery, or radiotherapy', 'active monitoring, surgery, and radiotherapy', 'radiotherapy', 'Radiotherapy']","['Adjusted mean costs, QALYs, and incremental cost-effectiveness ratios']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.173558,"Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery).","[{'ForeName': 'Sian M', 'Initials': 'SM', 'LastName': 'Noble', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK. s.m.noble@bristol.ac.uk.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Thorn', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'The School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology and Surgery, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'The Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'The Academic Urology Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'The School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Sheffield Teaching Hospitals, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'The School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}]",British journal of cancer,['10.1038/s41416-020-0978-4']
2783,32669708,The National Lung Matrix Trial of personalized therapy in lung cancer.,"The majority of targeted therapies for non-small-cell lung cancer (NSCLC) are directed against oncogenic drivers that are more prevalent in patients with light exposure to tobacco smoke 1-3 . As this group represents around 20% of all patients with lung cancer, the discovery of stratified medicine options for tobacco-associated NSCLC is a high priority. Umbrella trials seek to streamline the investigation of genotype-based treatments by screening tumours for multiple genomic alterations and triaging patients to one of several genotype-matched therapeutic agents. Here we report the current outcomes of 19 drug-biomarker cohorts from the ongoing National Lung Matrix Trial, the largest umbrella trial in NSCLC. We use next-generation sequencing to match patients to appropriate targeted therapies on the basis of their tumour genotype. The Bayesian trial design enables outcome data from open cohorts that are still recruiting to be reported alongside data from closed cohorts. Of the 5,467 patients that were screened, 2,007 were molecularly eligible for entry into the trial, and 302 entered the trial to receive genotype-matched therapy-including 14 that re-registered to the trial for a sequential trial drug. Despite pre-clinical data supporting the drug-biomarker combinations, current evidence shows that a limited number of combinations demonstrate clinically relevant benefits, which remain concentrated in patients with lung cancers that are associated with minimal exposure to tobacco smoke.",2020,Umbrella trials seek to streamline the investigation of genotype-based treatments by screening tumours for multiple genomic alterations and triaging patients to one of several genotype-matched therapeutic agents.,"['lung cancer', '19 drug-biomarker cohorts from the ongoing National Lung Matrix Trial, the largest umbrella trial in NSCLC', 'patients with light exposure to tobacco smoke 1-3 ', 'patients with lung cancers', '5,467 patients that were screened, 2,007 were molecularly eligible for entry into the trial, and 302 entered the trial to receive genotype-matched therapy-including 14 that re-registered\xa0to the trial for a sequential trial drug']",['personalized therapy'],[],"[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4761125', 'cui_str': 'Exposure to tobacco'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],5467.0,0.0938514,Umbrella trials seek to streamline the investigation of genotype-based treatments by screening tumours for multiple genomic alterations and triaging patients to one of several genotype-matched therapeutic agents.,"[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'Institute of Immunology & Immunotherapy, University of Birmingham, Birmingham, UK. g.middleton@bham.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fletcher', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Savage', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Summers', 'Affiliation': 'The Christie, Manchester, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Greystoke', 'Affiliation': 'Newcastle University, Newcastle, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Cave', 'Affiliation': 'Southampton University Hospitals NHS Trust, Southampton, UK.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': ""O'Rourke"", 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brewster', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Toy', 'Affiliation': 'Royal Devon and Exeter Foundation NHS Trust, Exeter, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': ""King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Dangoor', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Mackean', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Forster', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Wherton', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Manita', 'Initials': 'M', 'LastName': 'Mehmi', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Sharpe', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mills', 'Affiliation': 'Cancer Research UK, London, UK.'}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Cerone', 'Affiliation': 'Cancer Research UK, London, UK.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Yap', 'Affiliation': 'The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thomas B K', 'Initials': 'TBK', 'LastName': 'Watkins', 'Affiliation': 'The Francis Crick Institute, London, UK.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'The Francis Crick Institute, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Swanton', 'Affiliation': 'The Francis Crick Institute, London, UK.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Billingham', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}]",Nature,['10.1038/s41586-020-2481-8']
2784,32669717,Investigation of the safety and feasibility of AAV1/SERCA2a gene transfer in patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL.,"The SERCA-LVAD trial was a phase 2a trial assessing the safety and feasibility of delivering an adeno-associated vector 1 carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a) to adult chronic heart failure patients implanted with a left ventricular assist device. The SERCA-LVAD trial was one of a program of AAV1/SERCA2a cardiac gene therapy trials including CUPID1, CUPID 2 and AGENT trials. Enroled subjects were randomised to receive a single intracoronary infusion of 1 × 10 13  DNase-resistant AAV1/SERCA2a particles or a placebo solution in a double-blinded design, stratified by presence of neutralising antibodies to AAV. Elective endomyocardial biopsy was performed at 6 months unless the subject had undergone cardiac transplantation, with myocardial samples assessed for the presence of exogenous viral DNA from the treatment vector. Safety assessments including ELISPOT were serially performed. Although designed as a 24 subject trial, recruitment was stopped after five subjects had been randomised and received infusion due to the neutral result from the CUPID 2 trial. Here we describe the results from the 5 patients at 3 years follow up, which confirmed that viral DNA was delivered to the failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation. Absolute levels of detectable transgene DNA were low, and no functional benefit was observed. There were no safety concerns in this small cohort. This trial identified some of the challenges of performing gene therapy trials in this LVAD patient cohort which may help guide future trial design.",2020,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","['adult chronic heart failure patients implanted with a left ventricular assist device', 'patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL']","['Elective endomyocardial biopsy', 'sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a', 'single intracoronary infusion of 1\u2009×\u200910 13  DNase-resistant AAV1/SERCA2a particles or a placebo solution', 'AAV1/SERCA2a gene transfer', 'failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy'}, {'cui': 'C0916181', 'cui_str': 'Calcium-Transporting ATPases, Sarcoplasmic Reticulum'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0011519', 'cui_str': 'Deoxyribonuclease I'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]",[],,0.220029,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK. a.lyon@imperial.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Babalis', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Morley-Smith', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedger', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Suarez Barrientos', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Foldes', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Couch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Chowdhury', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Tzortzis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Peters', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rog-Zielinska', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'H-Y', 'Initials': 'HY', 'LastName': 'Yang', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Welch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Bowles', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rahman Haley', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Bell', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rice', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Falaschetti', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parameshwar', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tsui', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pepper', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Rudy', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Zsebo', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Macleod', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Terracciano', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Hajjar', 'Affiliation': 'Phospholamban Foundation, Amsterdam, Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Banner', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Harding', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",Gene therapy,['10.1038/s41434-020-0171-7']
2785,32669121,A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analyses plan.,"BACKGROUND


We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan.
METHODS/DESIGN


A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance.
DISCUSSION


This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients.
TRIAL REGISTRATION


CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.",2020,"In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation.","['older patients', 'Surgery for Fractures']","['surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation', 'internal fixation to non-surgical management']","['radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.126119,"In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lawson', 'Affiliation': 'Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia. aalawson@tpg.com.au.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Naylor', 'Affiliation': 'Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ivers', 'Affiliation': 'School of Public Health and Community Medicine, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Balogh', 'Affiliation': 'John Hunter Hospital, Newcastle, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Canberra Hospital, Canberra, ACT, Australia.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Mittal', 'Affiliation': 'South Western Sydney Clinical School, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xuan', 'Affiliation': 'Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Vafa', 'Affiliation': 'Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Piers', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': 'Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Rieger', 'Affiliation': 'Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'St George and Sutherland Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Elkinson', 'Affiliation': 'Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'Woosung', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Sungaran', 'Affiliation': 'Concord Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Latendresse', 'Affiliation': 'Nambour Hospital and Sunshine Coast University Hospital, Nambour, QLD, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Westmead Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'Campbelltown Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Landale', 'Affiliation': 'Campbelltown Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Herwig', 'Initials': 'H', 'LastName': 'Drobetz', 'Affiliation': 'Mackay Base Hospital, Mackay, QLD, Australia.'}, {'ForeName': 'Phong', 'Initials': 'P', 'LastName': 'Tran', 'Affiliation': 'Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'University Hospital Geelong, Barwon Health, Geelong, NSW, Australia.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Hau', 'Affiliation': 'Northern Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mulford', 'Affiliation': 'Launceston Hospital, Launceston, TAS, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Incoll', 'Affiliation': 'Gosford and Wyong Hospitals, Gosford, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kale', 'Affiliation': 'Gosford and Wyong Hospitals, Gosford, NSW, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Schick', 'Affiliation': 'Prince of Wales Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Higgs', 'Affiliation': ""St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Oppy', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Perriman', 'Affiliation': 'Canberra Hospital, Canberra, ACT, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Harris', 'Affiliation': 'Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.'}]",Trials,['10.1186/s13063-020-4228-0']
2786,32669132,"Correction to: Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],['home- and gym-based resistance exercise training'],"['glycaemic control, body composition and muscle strength']",[],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0448273,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al Ozairi', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dalal', 'Initials': 'D', 'LastName': 'Alsaeed', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Taliping', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Jalali', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'El Samad', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mashankar', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Etab', 'Initials': 'E', 'LastName': 'Taghadom', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Guess', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Gray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK. stuart.gray@glasgow.ac.uk.'}]",Trials,['10.1186/s13063-020-04597-4']
2787,31038216,Attachment style predicts cooperation in intuitive but not deliberative response in one-shot public goods game.,"Cooperation is an important prosocial behaviour that is of great significance to individuals and society. The social heuristics hypothesis (SHH) systematically explains how cooperation is interactively affected by intuitive and deliberative processes. On the one hand, the intuitive process can be either cooperative or selfish, which is determined by previous experience. On the other hand, the deliberative process could support either a cooperative decision or a selfish decision, depending on which strategy could maximise the current payoff. This research aims to investigate the mechanism of cooperation. Attachment style was selected as a proxy for previous experience to examine whether and how previous life experience shapes intuitive response. Time constraint (Studies 1 and 2) and cognitive load (Study 3) were manipulated to dissociate the intuitive and deliberative processes. In addition, cooperation was assessed by adopting one-shot public goods games. Results showed that attachment avoidance (Studies 1, 2, and 3) and attachment anxiety (Study 3) significantly predicted cooperation in the intuition condition, whereas these associations were insignificant in the deliberation condition (Studies 1, 2, and 3). These findings provide further support for the SHH and shed new light on the mechanism of cooperation.",2020,"Results showed that attachment avoidance (Studies 1, 2, and 3) and attachment anxiety (Study 3) significantly predicted cooperation in the intuition condition, whereas these associations were insignificant in the deliberation condition (Studies 1, 2, and 3).",[],[],"['attachment avoidance (Studies 1, 2, and 3) and attachment anxiety']",[],[],"[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",3.0,0.0206284,"Results showed that attachment avoidance (Studies 1, 2, and 3) and attachment anxiety (Study 3) significantly predicted cooperation in the intuition condition, whereas these associations were insignificant in the deliberation condition (Studies 1, 2, and 3).","[{'ForeName': 'Qianyun', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Xuying', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Hanyue', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Xiuxin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12584']
2788,32674587,Effects of exercise modality on body composition and cardiovascular disease risk factors in adolescents with obesity: A randomized clinical trial.,"We compared the effects of aerobic exercise (AE), resistance exercise (RE) and combined AE and RE on total, regional subcutaneous adipose tissue (SAT) and visceral AT (VAT), skeletal muscle (SM) and biomarkers of cardiovascular disease (CVD) in adolescents. 118 adolescents with overweight/obesity (BMI>85th percentile, 12-17 years) were randomized to one of the following groups for six months (three days/week, 180 min/week): AE (n=38), RE (n=40) or combined AE and RE (n=40). After accounting for age, sex and baseline value, there was a greater (P<0.05) reduction in body weight in the AE group compared to the RE, and the combined groups. There were reductions (P<0.05) in total and regional SAT within the AE group only, and the reductions in lower-body SAT were greater (P=0.02) than the combined group. All groups had reductions (P<0.01) in VAT, with no group differences. There were significant increases in total and regional SM mass in the RE and combined group, and not in the AE group. Although all exercise modalities are effective in reducing VAT, AE is superior at reducing total and regional SAT, but inferior for increasing SM in adolescents with obesity. Despite reductions in VAT, carotid-femoral pulse wave velocity and carotid intima-media thickness did not improve with either exercise. Clinicaltrials.gov identifier: NCT01938950 Novelty Bullets: ∙Regular exercise (180 min/week) is associated with reductions in visceral fat independent of exercise modality. ∙Resistance exercise alone and combined resistance and aerobic exercise are similarly effective in increasing skeletal muscle mass.",2020,"There were significant increases in total and regional SM mass in the RE and combined group, and not in the AE group.","['118 adolescents with overweight/obesity (BMI>85th percentile, 12-17 years', 'adolescents with obesity', 'adolescents']","['exercise modality', 'aerobic exercise (AE), resistance exercise (RE) and combined AE and RE', 'RE (n=40) or combined AE and RE', '∙Resistance exercise alone and combined resistance and aerobic exercise']","['lower-body SAT', 'VAT, carotid-femoral pulse wave velocity and carotid intima-media thickness', 'body weight', 'total and regional SM mass', 'body composition and cardiovascular disease risk factors', 'total, regional subcutaneous adipose tissue (SAT) and visceral AT (VAT), skeletal muscle (SM) and biomarkers of cardiovascular disease (CVD']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.061567,"There were significant increases in total and regional SM mass in the RE and combined group, and not in the AE group.","[{'ForeName': 'SoJung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University - Global Campus, 34983, Sports Medicine, Graduate School of Physical Education , 1732 Deogyeong-daero, Giheung-gu , Yongin, Gyeonggi-do, Korea (the Republic of) , 446-701 ; sojung.lee@khu.ac.kr.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Libman', 'Affiliation': ""Division of Pediatric Endocrinology, Metabolism and Diabetes Mellitus, UPMC Children's Hospital of Pittsburgh,, Pittsburgh, United States ; ingrid.libman@chp.edu.""}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Hughan', 'Affiliation': ""Children's Hospital of Pittsburgh of UPMC, Pediatrics , 4401 Penn Avenue , Pittsburgh, Pennsylvania, United States , 15224 ; kara.hughan@chp.edu.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kuk', 'Affiliation': 'York University , School of Kinesiology and Health Science , 2002 Sherman Health Science Centre , Toronto, Ontario, Canada , M3J 1P3 ; jennkuk@yorku.ca.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Barinas-Mitchell', 'Affiliation': 'University of Pittsburgh, 6614, Graduate School of Public Health, Pittsburgh, Pennsylvania, United States ; ejb4@pitt.edu.'}, {'ForeName': 'Hyeok', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Kyung Hee University, Department of Physical Education, Yongin , Korea (the Republic of) ; airryong@naver.com.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""Children's Hospital of Pittsburgh of UPMC, Pediatrics-Weight Management , 4401 Penn Avenue , Pittsburgh, Pennsylvania, United States , 15224 ; silva.arslanian@chp.edu.""}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0993']
2789,32674604,"Assessing the utility of cardiorespiratory fitness, visceral fat and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents.","To examine the utility of changes in cardiorespiratory fitness (CRF) and body composition in response to exercise training in adolescents with obesity beyond simple measures of body weight change. This is a secondary analysis of our previously published randomized trials of aerobic, resistance and combined training. We included 104 adolescents (BMI >85th percentile) who had complete baseline and post-intervention data for CRF, regional body fat, insulin sensitivity and oral glucose tolerance. Associations between changes in body composition and CRF with cardiometabolic variables were examined adjusted for age, sex, Tanner stage, race, exercise group and weight loss. At baseline, CRF, visceral fat and liver fat were correlated with insulin sensitivity with and without adjustment for BMI percentile. Training-associated changes in CRF, visceral fat and liver fat were also correlated with insulin sensitivity changes, but not independent of body weight change. After accounting for body weight change, none of the body composition or CRF were associated with changes in insulin sensitivity, glucose tolerance, systolic blood pressure or HDL cholesterol. Although CRF and body composition were strong independent correlates of insulin sensitivity at baseline, changes in CRF and visceral fat were not associated with changes in insulin sensitivity after accounting for body weight change. Novelty Bullets: ∙With exercise training, changes in body weight, CRF, visceral fat and liver fat were correlated with changes in insulin sensitivity. ∙Changes in body composition or CRF generally did not remain significant correlates of changes in insulin sensitivity after adjusting for body weight changes. Clinicaltrials.gov registration numbers: NCT00739180, NCT01323088, NCT01938950.",2020,"Training-associated changes in CRF, visceral fat and liver fat were also correlated with insulin sensitivity changes, but not independent of body weight change.","['adolescents with obesity beyond simple measures of body weight change', '104 adolescents (BMI >85th percentile) who had complete baseline and post-intervention data for CRF, regional body fat, insulin sensitivity and oral glucose tolerance', 'adolescents']",['exercise training'],"['body weight', 'CRF, visceral fat and liver fat', 'insulin sensitivity', 'body weight, CRF, visceral fat and liver fat', 'insulin sensitivity, glucose tolerance, systolic blood pressure or HDL cholesterol']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",104.0,0.0204715,"Training-associated changes in CRF, visceral fat and liver fat were also correlated with insulin sensitivity changes, but not independent of body weight change.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kuk', 'Affiliation': 'York University , School of Kinesiology and Health Science , 2002 Sherman Health Science Centre , Toronto, Ontario, Canada , M3J 1P3 ; jennkuk@yorku.ca.'}, {'ForeName': 'SoJung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University - Global Campus, 34983, Sports Medicine, Graduate School of Physical Education , 1732 Deogyeong-daero, Giheung-gu , Yongin, Gyeonggi-do, Korea (the Republic of) , 446-701 ; sojung.lee@khu.ac.kr.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0284']
2790,32670006,The After-Effect of Accelerated Intermittent Theta Burst Stimulation at Different Session Intervals.,"Objective


The study aims to investigate the after-effect of three sessions of intermittent theta-burst stimulation (iTBS) on motor cortical excitability. The iTBS was induced over the primary motor cortex (M1) at different time intervals.
Methods


The study has a crossover design. Sixteen participants were assigned to three groups and received different accelerated iTBS (aiTBS) protocols during each visit: (1) three continuous sessions with no interval (iTBS18000); (2) three iTBS sessions with 10-min intervals (iTBS600 × 3 ∗ 10); and (3) three iTBS sessions with 30-min intervals (iTBS600 × 3 ∗ 30). As washout period, each visit is separated by at least 7 days. We measured the motor cortical excitability changes and intracortical inhibition.
Results


A dose of 1,800 pulses of aiTBS per day is tolerable. The iTBS1800 led to a reduced cortical excitability; whereas iTBS600 × 3 ∗ 10 and iTBS600 × 3 ∗ 30 enhanced cortical excitability to a differential extent. After a total dose of 1,800 pulses, iTBS600 × 3 ∗ 30 exhibited the longer effect and highest percentage of individuals with enhanced cortical excitability.
Conclusion


The results suggest that aiTBS protocols at different time intervals result in different motor cortical excitability after-effects.",2020,"After a total dose of 1,800 pulses, iTBS600 × 3 ∗ 30 exhibited the longer effect and highest percentage of individuals with enhanced cortical excitability.
",['Sixteen participants'],"['accelerated iTBS (aiTBS) protocols during each visit: (1) three continuous sessions with no interval (iTBS18000); (2) three iTBS sessions with 10-min intervals (iTBS600 × 3 ∗ 10); and (3) three iTBS sessions with 30-min intervals (iTBS600 × 3 ∗ 30', 'intermittent theta-burst stimulation (iTBS']","['motor cortical excitability', 'reduced cortical excitability', 'motor cortical excitability changes and intracortical inhibition']","[{'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",16.0,0.152153,"After a total dose of 1,800 pulses, iTBS600 × 3 ∗ 30 exhibited the longer effect and highest percentage of individuals with enhanced cortical excitability.
","[{'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ruiping', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Sijie', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Weining', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yulian', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00576']
2791,32670027,Prolonged Continuous Theta Burst Stimulation of the Motor Cortex Modulates Cortical Excitability But not Pain Perception.,"Over the past decade, theta-burst stimulation (TBS) has become a focus of interest in neurostimulatory research. Compared to conventional repetitive transcranial magnetic stimulation (rTMS), TBS produces more robust changes in cortical excitability (CE). There is also some evidence of an analgesic effect of the method. Previously published studies have suggested that different TBS parameters elicit opposite effects of TBS on CE. While intermittent TBS (iTBS) facilitates CE, continuous TBS (cTBS) attenuates it. However, prolonged TBS (pTBS) with twice the number of stimuli produces the opposite effect. In a double-blind, placebo-controlled, cross-over study with healthy subjects ( n  = 24), we investigated the effects of various pTBS (cTBS, iTBS, and placebo TBS) over the right motor cortex on CE and pain perception. Changes in resting motor thresholds (RMTs) and absolute motor-evoked potential (MEP) amplitudes were assessed before and at two time-points (0-5 min; 40-45 min) after pTBS. Tactile and thermal pain thresholds were measured before and 5 min after application. Compared to the placebo, prolonged cTBS (pcTBS) transiently increased MEP amplitudes, while no significant changes were found after prolonged iTBS. However, the facilitation of CE after pcTBS did not induce a parallel analgesic effect. We confirmed that pcTBS with twice the duration converts the conventional inhibitory effect into a facilitatory one. Despite the short-term boost of CE following pcTBS, a corresponding analgesic effect was not demonstrated. Therefore, the results indicate a more complex regulation of pain, which cannot be explained entirely by the modulation of excitability.",2020,"Compared to the placebo, prolonged cTBS (pcTBS) transiently increased MEP amplitudes, while no significant changes were found after prolonged iTBS.",['healthy subjects ( n  = 24'],"['various pTBS (cTBS, iTBS, and placebo TBS', 'conventional repetitive transcranial magnetic stimulation (rTMS), TBS', 'theta-burst stimulation (TBS', 'placebo']","['prolonged TBS (pTBS', 'prolonged cTBS (pcTBS) transiently increased MEP amplitudes', 'resting motor thresholds (RMTs) and absolute motor-evoked potential (MEP) amplitudes', 'cortical excitability (CE', 'Tactile and thermal pain thresholds']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",,0.110462,"Compared to the placebo, prolonged cTBS (pcTBS) transiently increased MEP amplitudes, while no significant changes were found after prolonged iTBS.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Klírová', 'Affiliation': 'Clinical Centre, National Institute of Mental Health, Klecany, Czechia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hejzlar', 'Affiliation': 'Clinical Centre, National Institute of Mental Health, Klecany, Czechia.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Kostýlková', 'Affiliation': 'Clinical Centre, National Institute of Mental Health, Klecany, Czechia.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Clinical Centre, National Institute of Mental Health, Klecany, Czechia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rokyta', 'Affiliation': 'Department of Normal, Pathological and Clinical Physiology, Third Faculty of Medicine, Charles University, Prague, Czechia.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Novák', 'Affiliation': 'Clinical Centre, National Institute of Mental Health, Klecany, Czechia.'}]",Frontiers in systems neuroscience,['10.3389/fnsys.2020.00027']
2792,32670031,Single-Dose of Testosterone and the  MAOA  VNTR Polymorphism Influence Emotional and Behavioral Responses in Men During a Non-social Frustration Task.,"Previous studies suggest that testosterone and several neurotransmitters might interactively influence human aggression. The current study aimed to test potential interactions of a genetic variation linked to the catabolism of serotonin, dopamine, and norepinephrine and exogenous testosterone on the reaction towards non-social provocation. In total, 146 male participants were genotyped for a prominent polymorphism of the monoamine oxidase A ( MAOA ) gene resulting in a short and long variant. Participants completed a non-social frustration task after receiving either testosterone or a placebo gel in a double-blind set-up. Participants performed a non-social frustration task, where they had to direct a virtually moving ball into a barrel by pulling a joystick (neutral block). During a frustration block, the joystick repeatedly did not respond to participants' reactions thereby causing failed trials to which participants reacted with increased anger and stronger pulling of the joystick. We analyzed the effect of testosterone administration on emotion and behavior in individuals who either carried a low (L) or high (H) activity  MAOA  variant. Testosterone administration increased provocation-related self-reported anger and abolished the association between trait aggression and joystick deflection in the frustration block. In  MAOA -H carriers endogenous testosterone levels at baseline were associated with increased joystick deflection in both blocks. There was, however, no interaction of testosterone administration and genotype. Although preliminary, the results rather indicate independent influences of exogenous testosterone administration and  MAOA , but support an interaction of endogenous testosterone levels and  MAOA  genetics in a frustration task. The administration of testosterone seems to act on the subjective emotional experience in a provoking situation, while endogenous testosterone levels increased pulling impulses only in carriers of the  MAOA -H variant.",2020,Participants completed a non-social frustration task after receiving either testosterone or a placebo gel in a double-blind set-up.,"['Participants completed a non-social frustration task after receiving either', 'Participants performed a non-social frustration task, where they had to direct a virtually moving ball into a barrel by pulling a joystick (neutral block', 'Men', 'individuals who either carried a low (L) or high (H) activity  MAOA  variant', '146 male participants were genotyped for a prominent polymorphism of the monoamine oxidase A ( MAOA ) gene resulting in a short and long variant']","['testosterone or a placebo gel', 'testosterone', 'serotonin, dopamine, and norepinephrine and exogenous testosterone', 'Testosterone']","['testosterone levels', 'joystick deflection', 'emotion and behavior']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025627', 'cui_str': 'Methaqualone'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0026455', 'cui_str': 'Monoamine Oxidase A'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",146.0,0.122028,Participants completed a non-social frustration task after receiving either testosterone or a placebo gel in a double-blind set-up.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wagels', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik, RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Votinov', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik, RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Hüpen', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik, RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Molecular Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Montag', 'Affiliation': 'Department of Molecular Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik, RWTH Aachen, Aachen, Germany.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2020.00093']
2793,32670049,A Single 30 Minutes Bout of Combination Physical Exercises Improved Inhibition and Vigor-Mood in Middle-Aged and Older Females: Evidence From a Randomized Controlled Trial.,"Background


Long-term combination of physical exercises has reported benefits for cognitive functions and mood states. However, it remains unclear whether a single bout of combination exercise training has acute positive effects on cognitive functions and mood states in middle-aged and older women. It is important to investigate acute effect of physical exercise because it would help to understand a mechanism of benefits of physical exercise. The purpose of this study was to investigate 30 min of a single bout of combination exercise training on cognition and mood states in middle-aged and older females.
Methods


In this single-blinded randomized control trial (RCT), middle-aged and older females were assigned randomly to two groups: a combination exercise group and a no-exercise control group. The former group did the combination exercise training (aerobic, strength, and stretching exercises) for 30 min. Meanwhile, the latter group did not do any exercise and waited for 30 min. We measured cognitive functions and mood performance states before and after the exercise or control interventions.
Results


Our main results demonstrated that, compared to the control group, the combination exercise improved inhibition (reverse Stroop and Stroop) and increased vigor-activity mood scores in both middle-aged and older groups. We also found that the only combination exercise group showed the significant positive correlations between improved inhibition performance and improved vigor-activity mood.
Discussion


This randomized controlled trial revealed the acute benefits of combination exercise on inhibition in executive functions and vigor-activity in the healthy middle-aged and older females. Our results provided the scientific evidence related to acute effects of the single bout of the combination exercise training. It suggests that we would be better to do the 30 min physical exercise for our health.
Clinical Trial Registration


This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000029681). Registered 24 October 2017, https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000033922.",2020,"Our main results demonstrated that, compared to the control group, the combination exercise improved inhibition (reverse Stroop and Stroop) and increased vigor-activity mood scores in both middle-aged and older groups.","['Middle-Aged and Older Females', 'middle-aged and older females', 'healthy middle-aged and older females', 'middle-aged and older women']","['combination exercise training', 'combination exercise', 'combination exercise training (aerobic, strength, and stretching exercises', 'Combination Physical Exercises', 'physical exercises', 'combination exercise group and a no-exercise control group']","['Inhibition and Vigor-Mood', 'cognitive functions and mood performance states', 'cognitive functions and mood states', 'inhibition performance and improved vigor-activity mood', 'cognition and mood states', 'combination exercise improved inhibition (reverse Stroop and Stroop) and increased vigor-activity mood scores', 'executive functions and vigor-activity']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.130085,"Our main results demonstrated that, compared to the control group, the combination exercise improved inhibition (reverse Stroop and Stroop) and increased vigor-activity mood scores in both middle-aged and older groups.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Smart Aging Research Center, Tohoku University, Sendai, Japan.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.00179']
2794,32670115,Null Effect of Olfactory Training With Patients Suffering From Depressive Disorders-An Exploratory Randomized Controlled Clinical Trial.,"Due to a close functional relation between brain areas processing emotion and those processing olfaction, major depression is often accompanied by reduced olfactory function. Such hyposmia can be improved by regular olfactory training (OT) over several months. As this training furthermore improves subjective well-being, we explored whether OT is a useful complementary strategy for depression treatment. A total of 102 depressive outpatients were randomly assigned to OT or a control training condition, which were performed twice a day for 16 weeks. Compliance was continuously monitored. Before and after training we measured depression severity and olfactory function. About half of the patients of both groups did not complete the training. Among the remaining patients, depression severity decreased significantly in both groups. The absence of an interaction effect indicated no selective impact of OT and the variance of depression improvement explained by OT was as little as 0.1%. The low compliance suggests that OT is not feasible for large parts of our sample of depressive outpatients, most likely due to a disease-immanent lack of motivation. In those patients who completed the training, lack of specific effects suggest that OT is not more useful then unspecific activation or attention training.
Clinical Trial Registration


This clinical trial was registered at German Registry for Clinical Trials (DRKS), main ID: DRKS00016350, URL: http://www.drks.de/DRKS00016350.",2020,"Among the remaining patients, depression severity decreased significantly in both groups.","['102 depressive outpatients', 'Patients Suffering From Depressive Disorders']","['OT', 'Olfactory Training', 'OT or a control training condition']","['depression severity', 'depression severity and olfactory function']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",102.0,0.0370164,"Among the remaining patients, depression severity decreased significantly in both groups.","[{'ForeName': 'Luise D', 'Initials': 'LD', 'LastName': 'Pabel', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Murr', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Weidner', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Croy', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00593']
2795,32670135,The Mediating Role of Non-reactivity to Mindfulness Training and Cognitive Flexibility: A Randomized Controlled Trial.,"Mindfulness training has been shown to have a beneficial effect on cognitive flexibility. However, little is known about the mediators that produce this effect. Cross-sectional studies show that there might be a link between Non-judgment, Non-reactivity and cognitive flexibility. Longitudinal studies examining whether Non-judgment or Non-reactivity mediate the effectiveness of mindfulness training on improving cognitive flexibility are lacking. The present study aims to test the effect of mindfulness training on increasing cognitive flexibility and to test whether this effect is mediated by Non-judgment or Non-reactivity. We conducted a single-blind randomized controlled trial in 54 nonclinical high-stress participants between October 2018 and January 2019. Participants were randomly assigned to a Mindfulness Based Stress Reduction (MBSR) group or a waitlist control group. The experimenters were blind to the group assignment of participants. The MBSR group received 8-weekly sessions (2.5-h per week) and a one-day retreat (6-h), and was required to accomplish a 45-min daily formal practice during the intervention. The waitlist control group did not receive any intervention during the waiting period and received a 2-day (6-h per day) mindfulness training after the post-intervention. The primary outcome was self-report cognitive flexibility and perceived stress administered before and after MBSR. The secondary outcome was self-report mindfulness skills (including Non-reactivity and Non-judgment) measured at pre-treatment, Week 3, Week 6, and post-intervention. For cognitive flexibility, mixed-model repeated-measure ANOVA results showed that there were significant main effects of Time, Group and a significant interaction of Time by Group. Follow-up ANOVA indicated that the MBSR group was associated with greater improvements in cognitive flexibility than the waitlist. Path analysis results showed that the effect of the treatment on cognitive flexibility at post-treatment was fully mediated by Non-reactivity at Week 6. The mediation effects of Non-reactivity at Week 3, and Non-judgment at Week 3 and Week 6 were not significant. Our findings support the efficacy of MBSR on improving cognitive flexibility. Non-reactivity is an important element of the effectiveness of MBSR training on cognitive flexibility.",2020,Follow-up ANOVA indicated that the MBSR group was associated with greater improvements in cognitive flexibility than the waitlist.,['54 nonclinical high-stress participants between October 2018 and January 2019'],"['waitlist control group did not receive any intervention during the waiting period and received a 2-day (6-h per day) mindfulness training', 'Mindfulness Based Stress Reduction (MBSR) group or a waitlist control group', 'MBSR training', 'Mindfulness Training and Cognitive Flexibility', 'MBSR', 'mindfulness training', 'Mindfulness training']","['cognitive flexibility', 'self-report mindfulness skills (including Non-reactivity and Non-judgment', 'self-report cognitive flexibility and perceived stress administered before and after MBSR']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",54.0,0.0152116,Follow-up ANOVA indicated that the MBSR group was associated with greater improvements in cognitive flexibility than the waitlist.,"[{'ForeName': 'Yingmin', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Beijing Key Laboratory of Behavior and Mental Health, School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Beijing Key Laboratory of Behavior and Mental Health, School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, United States.'}, {'ForeName': 'Xinghua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Beijing Key Laboratory of Behavior and Mental Health, School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01053']
2796,32670418,"The effect of crocin supplementation on glycemic control, insulin resistance and active AMPK levels in patients with type 2 diabetes: a pilot study.","Background


Crocin as a carotenoid exerts anti-oxidant, anti-inflammatory, anti-cancer, neuroprotective and cardioprotective effects. Besides, the increasing prevalence of diabetes mellitus and its allied complications, and also patients' desire to use natural products for treating their diseases, led to the design of this study to evaluate the efficacy of crocin on glycemic control, insulin resistance and active adenosine monophosphate-activated protein kinase (AMPK) levels in patients with type-2 diabetes (T2D).
Methods


In this clinical trial with a parallel-group design, 50 patients with T2D received either 15-mg crocin or placebo, twice daily, for 12 weeks. Anthropometric measurements, dietary intake, physical activity, blood pressure, glucose homeostasis parameters, active form of AMPK were assessed at the beginning and at the end of the study.
Results


Compared with the placebo group, crocin improved fasting glucose level ( P  = 0.015), hemoglobin A1c ( P  = 0.045), plasma insulin level ( P  = 0.046), insulin resistance ( P  = 0.001), and insulin sensitivity ( P  = 0.001). Based on the within group analysis, crocin led to significant improvement in plasma levels of glucose, insulin, hemoglobin A1c, systolic blood pressure, insulin resistance and insulin sensitivity. The active form of AMPK did not change within and between groups after intervention.
Conclusions


The findings indicate that crocin supplementation can improve glycemic control and insulin resistance in patients with T2D. Further studies are needed to confirm these findings. Trial Registration  This study has been registered at Clinicaltrial.gov with registration number NCT04163757.",2020,"Compared with the placebo group, crocin improved fasting glucose level ( P  = 0.015), hemoglobin A1c ( P  = 0.045), plasma insulin level ( P  = 0.046), insulin resistance ( P  = 0.001), and insulin sensitivity ( P  = 0.001).","['50 patients with T2D received either', 'patients with type-2 diabetes (T2D', 'patients with type 2 diabetes']","['crocin supplementation', '15-mg crocin or placebo', 'placebo']","['plasma insulin level', 'hemoglobin A1c', 'glycemic control, insulin resistance and active AMPK levels', 'Anthropometric measurements, dietary intake, physical activity, blood pressure, glucose homeostasis parameters, active form of AMPK', 'insulin resistance', 'glycemic control and insulin resistance', 'insulin sensitivity', 'fasting glucose level', 'plasma levels of glucose, insulin, hemoglobin A1c, systolic blood pressure, insulin resistance and insulin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0056503', 'cui_str': 'crocin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",50.0,0.0881048,"Compared with the placebo group, crocin improved fasting glucose level ( P  = 0.015), hemoglobin A1c ( P  = 0.045), plasma insulin level ( P  = 0.046), insulin resistance ( P  = 0.001), and insulin sensitivity ( P  = 0.001).","[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, West Arghavan Street, Farahzadi Blvd., P.O. Box:19395-4741, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dastkhosh', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, West Arghavan Street, Farahzadi Blvd., P.O. Box:19395-4741, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Imam-Hossein General Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Sharafkhah', 'Affiliation': 'Digestive Oncology Research Center, Digestive Diseases Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, West Arghavan Street, Farahzadi Blvd., P.O. Box:19395-4741, Tehran, Iran.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-020-00568-6']
2797,32670431,Exploring Cancer Patients' Experiences of an Online Mindfulness-Based Program: A Qualitative Investigation.,"Objective


Chronic neuropathic pain (CNP) is a common condition cancer survivors experience. Mindfulness training may be one approach to address the psychosocial factors associated with CNP. The purpose of this study was to understand patients' experiences in an 8-week online mindfulness-based program (MBP), including techniques and skills learned and applied, barriers to practice, and research experiences.
Methods


Nineteen participants who were part of a randomized controlled trial consented to participate in a telephone interview or submit written responses via email post-course. Interviews were transcribed and analyzed using the principles of Applied Thematic Analysis (ATA).
Results


Predominant themes identified in participant interviews included (1) common humanity, (2) convenience, (3) teacher resonance, (4) perceived relaxation and calm, (5) pain and stress management, (6) half-day session, and (7) mindful breathing. Participants also identified helpful strategies learned and implemented from the course, as well as barriers to practice, and key components of their experiences in a randomized controlled trial, including a sense of disconnection post-course and needing continued ongoing sessions, and the importance of the facilitators' skills in creating a comfortable and supportive space.
Conclusions


An online group-based MBP may offer a more accessible resource and form of psychosocial intervention and support for cancer survivors living with CNP. Furthermore, the need and consideration for implementing ongoing group maintenance sessions to minimize participants' feelings of disconnect and abandonment post-course and post-study are warranted in future MBP development.",2020,"Furthermore, the need and consideration for implementing ongoing group maintenance sessions to minimize participants' feelings of disconnect and abandonment post-course and post-study are warranted in future MBP development.","[""patients' experiences in an 8-week"", 'cancer survivors living with CNP', 'Methods\n\n\nNineteen participants who were part of a randomized controlled trial consented to participate in a']","['telephone interview or submit written responses via email post-course', 'online mindfulness-based program (MBP', 'Online Mindfulness-Based Program', 'Mindfulness training']","['common humanity, (2) convenience, (3) teacher resonance, (4) perceived relaxation and calm, (5) pain and stress management, (6) half-day session, and (7) mindful breathing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",19.0,0.0281218,"Furthermore, the need and consideration for implementing ongoing group maintenance sessions to minimize participants' feelings of disconnect and abandonment post-course and post-study are warranted in future MBP development.","[{'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Glynn', 'Affiliation': 'The Ottawa Hospital Research Institute, The Ottawa Hospital - General, Smyth Road, Ottawa, ON K1H 8L6 Canada.'}, {'ForeName': 'Eve-Ling', 'Initials': 'EL', 'LastName': 'Khoo', 'Affiliation': 'The Ottawa Hospital Research Institute, The Ottawa Hospital - General, Smyth Road, Ottawa, ON K1H 8L6 Canada.'}, {'ForeName': 'Hayley M L', 'Initials': 'HML', 'LastName': 'MacLeay', 'Affiliation': 'The Ottawa Hospital Research Institute, The Ottawa Hospital - General, Smyth Road, Ottawa, ON K1H 8L6 Canada.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'The Ottawa Hospital Research Institute, The Ottawa Hospital - General, Smyth Road, Ottawa, ON K1H 8L6 Canada.'}, {'ForeName': 'Rosemee', 'Initials': 'R', 'LastName': 'Cantave', 'Affiliation': 'The Ottawa Hospital Research Institute, The Ottawa Hospital - General, Smyth Road, Ottawa, ON K1H 8L6 Canada.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Poulin', 'Affiliation': 'The Ottawa Hospital Research Institute, The Ottawa Hospital - General, Smyth Road, Ottawa, ON K1H 8L6 Canada.'}]",Mindfulness,['10.1007/s12671-020-01380-z']
2798,32670497,"Effectiveness of NexQuest Natural Frequency Technology ®  on sleep and mood of adults with insomnia symptoms: a randomized, double blind and placebo controlled crossover trial.","Objectives


The study purpose was to conduct a four-week randomized double-blind placebo-controlled crossover trial on adults with insomnia symptoms to examine the effectiveness of Natural Frequency Technology (®)  (NFT), found in Philip Stein Sleep Bracelets, on sleep quality, anxiety/stress levels, and mood.
Methods


Adults ( N  = 44,  M  age = 41.9 years) were randomized to the Placebo Bracelet (PB) or NFT Sleep Bracelet (SB) for two weeks and then the alternative bracelet for two weeks. Self-reported mood, anxiety/stress, and sleep quality were completed at Day 0 (PRE) and following each condition; POST PB and POST SB).
Results


When the participants wore the SB, compared to the PB, they had improved sleep quality (i.e., Pittsburgh Sleep Quality Index), anxiety/perceived stress, and mood,  p 's < .05.
Discussion


The SB may be simple, noninvasive, and non-pharmacological intervention to improve sleep quality and daytime mood.",2020,"When the participants wore the SB, compared to the PB, they had improved sleep quality (i.e., Pittsburgh Sleep Quality Index), anxiety/perceived stress, and mood,  p 's < .05.
","['adults with insomnia symptoms', 'Methods\n\n\nAdults ( N  = 44,  M  age = 41.9 years']","['Placebo Bracelet (PB) or NFT Sleep Bracelet (SB', 'Natural Frequency Technology (®)  (NFT', 'NexQuest Natural Frequency Technology ®', 'placebo']","['Self-reported mood, anxiety/stress, and sleep quality', 'sleep quality and daytime mood', 'sleep quality (i.e., Pittsburgh Sleep Quality Index), anxiety/perceived stress, and mood', 'sleep quality, anxiety/stress levels, and mood']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085400', 'cui_str': 'Neurofibrillary degeneration'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",,0.31952,"When the participants wore the SB, compared to the PB, they had improved sleep quality (i.e., Pittsburgh Sleep Quality Index), anxiety/perceived stress, and mood,  p 's < .05.
","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hooper', 'Affiliation': 'Jacksonville University, Applied Health Sciences - Jacksonville - FL - United States.'}, {'ForeName': 'Tarah', 'Initials': 'T', 'LastName': 'Lynch', 'Affiliation': 'Jacksonville University, Applied Health Sciences - Jacksonville - FL - United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Coyle', 'Affiliation': 'Jacksonville University, Applied Health Sciences - Jacksonville - FL - United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hooper', 'Affiliation': 'Jacksonville University, Applied Health Sciences - Jacksonville - FL - United States.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Hausenblas', 'Affiliation': 'Jacksonville University, Applied Health Sciences - Jacksonville - FL - United States.'}]","Sleep science (Sao Paulo, Brazil)",['10.5935/1984-0063.20190125']
2799,32670598,Protocol for Take-home naloxone In Multicentre Emergency (TIME) settings: feasibility study.,"Background


Opioids, such as heroin, kill more people worldwide by overdose than any other type of drug, and death rates associated with opioid poisoning in the UK are at record levels (World Drug Report 2018 [Internet]. [cited 2019 Nov 19]. Available from: http://www.unodc.org/wdr2018/; Deaths related to drug poisoning in England and Wales - Office for National Statistics [Internet]. [cited 2019 Nov 19]. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2018registrations). Naloxone is an opioid antagonist which can be distributed in 'kits' for administration by witnesses in an overdose emergency. This intervention is known as take-home naloxone (THN). We know that THN can save lives on an individual level, but there is currently limited evidence about the effectiveness of THN distribution on an aggregate level, in specialist drug service settings or in emergency service settings. Notably, we do not know whether THN kits reduce deaths from opioid overdose in at-risk populations, if there are unforeseen harms associated with THN distribution or if THN is cost-effective. In order to address this research gap, we aim to determine the feasibility of a fully powered cluster randomised controlled trial (RCT) of THN distribution in emergency settings.
Methods


We will carry out a feasibility study for a RCT of THN distributed in emergency settings at four sites, clustered by Emergency Department (ED) and catchment area within its associated ambulance service. THN is a peer-administered intervention. At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose. At two control sites, practice will carry on as usual. We will develop a method of identifying a population to include in an evaluation, comprising people at risk of fatal opioid overdose, who may potentially receive naloxone included in a THN kit.We will gather anonymised outcomes up to 1 year following a 12-month 'live' trial period for patients at risk of death from opioid poisoning. We expect approximately 100 patients at risk of opioid overdose to be in contact with each service during the 1-year recruitment period. Our outcomes will include deaths, emergency admissions, intensive care admissions, and ED attendances. We will collect numbers of eligible patients attended by participating in emergency ambulance paramedics and attending ED, THN kits issued, and NHS resource usage. We will determine whether to progress to a fully powered trial based on pre-specified progression criteria: sign-up of sites ( n  = 4), staff trained (≥ 50%), eligible participants identified (≥ 50%), THN provided to eligible participants (≥ 50%), people at risk of death from opioid overdose identified for inclusion in follow-up (≥ 75% of overdose deaths), outcomes retrieved for high-risk individuals (≥ 75%), and adverse event rate (< 10% difference between study arms).
Discussion


This feasibility study is the first randomised, methodologically robust investigation of THN distribution in emergency settings. The study addresses an evidence gap related to the effectiveness of THN distribution in emergency settings. As this study is being carried out in emergency settings, obtaining informed consent on behalf of participants is not feasible. We therefore employ novel methods for identifying participants and capturing follow-up data, with effectiveness dependent on the quality of the available routine data.
Trial registration


ISRCTN13232859 (Registered 16/02/2018).",2020,"At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose.","['adult patients who are at risk of opioid overdose', '100 patients at risk of opioid overdose to be in contact with each service during the 1-year recruitment period', 'RCT of THN distributed in emergency settings at four sites, clustered by Emergency Department (ED) and catchment area within its associated ambulance service', 'patients at risk of death from opioid poisoning', 'eligible patients attended by participating in emergency ambulance paramedics and attending ED, THN kits issued, and NHS resource usage']","['THN', 'THN kits', 'naloxone', 'Naloxone']","['deaths, emergency admissions, intensive care admissions, and ED attendances', 'adverse event rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]","[{'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.151038,"At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Swansea University, Wales, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Bell', 'Affiliation': 'Yorkshire Ambulance Service, England, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Benger', 'Affiliation': 'University of the West of England, England, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Black', 'Affiliation': 'South Western Ambulance Services NHS Foundation Trust, England, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Buykx', 'Affiliation': 'University of Sheffield, England, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': 'University of Sheffield, England, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Driscoll', 'Affiliation': 'Swansea University, Wales, UK.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'Evans', 'Affiliation': 'Swansea University, Wales, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Cardiff University, Wales, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fuller', 'Affiliation': 'University of Sheffield, England, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Goodacre', 'Affiliation': 'University of Sheffield, England, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hoskins', 'Affiliation': 'University of the West of England, England, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hughes', 'Affiliation': 'University of Sheffield, England, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'John', 'Affiliation': 'Swansea University, Wales, UK.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Swansea University, Wales, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Swansea University, Wales, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Sampson', 'Affiliation': 'University of Sheffield, England, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Swansea University, Wales, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Snooks', 'Affiliation': 'Swansea University, Wales, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00626-w']
2800,32670599,Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study.,"Background


People with hypermobility spectrum disorder (HSD) are in great risk of experiencing shoulder symptoms, but evidence for treatment is sparse. Therefore, the objective was to evaluate the feasibility of 16-week shoulder strengthening programme for improving shoulder strength and function in people with HSD and shoulder symptoms for more than 3 months to inform a future randomised controlled trial (RCT).
Methods


Twelve participants (11 females, 39.3 ± 13.9 years) with HSD and shoulder instability and/or pain for more than 3 months underwent a 16-week heavy shoulder strengthening exercise programme three times weekly using exercises targeting scapular and rotator cuff muscles. Primary outcomes were pre-defined research progression criteria including recruitment rate (acceptable, 6 participants/month), assessment duration (acceptable: < 120 min), participant retention (acceptable: > 80% complete intervention), training adherence (acceptable: > 75% adhere to > 36 training sessions) and adverse events (acceptable: minor events with no participants discontinuing the study), besides participant and physiotherapist feedback. Secondary treatment outcomes were assessed using the Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse), self-reported pain, kinesiophobia and fatigue, isometric shoulder strength, besides clinical tests for instability, hypermobility, laxity, and proprioception.
Results


Recruitment rate was 5.6/month, assessment duration (mean ± SD) 105 ± 9 min, retention 100%, adherence 83%, and four participants experienced short-lasting soreness or pain. Participant feedback was positive, and physiotherapists found the intervention relevant and applicable to the population. The WOSI total score showed an improvement by 51% (mean ± SD, points: baseline 1037 ± 215; Follow up 509 ± 365; mean change (95% CI), - 528 (- 738, - 318)), and participants reported reduced pain, kinesiophobia and fatigue. Shoulder strength measurements improved by 28-31% (mean change (95% CI), Nm/kg: scaption 0.51 (0.23, 0.78); internal rotation 1.32 (0.70, 1.95) and external rotation 0.89 (0.37, 1.40)), and clinical tests indicated decreased shoulder laxity/instability.
Conclusions


The shoulder strengthening exercise programme was feasible and safe for people with HSD and long-lasting shoulder symptoms. A future RCT, with an improved recruitment strategy, will demonstrate whether the exercise programme is also effective in improving symptoms and muscle-tendon function in this population.
Trial registration


ClinicalTrials.gov: NCT03547570. Registered on May 3, 2018.",2020,"Shoulder strength measurements improved by 28-31% (mean change (95% CI), Nm/kg: scaption 0.51 (0.23, 0.78); internal rotation 1.32 (0.70, 1.95) and external rotation 0.89 (0.37, 1.40)), and clinical tests indicated decreased shoulder laxity/instability.
","['people with HSD and shoulder symptoms for more than 3\u2009months', '\n\n\nPeople with hypermobility spectrum disorder (HSD', 'people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms', 'people with HSD and long-lasting shoulder symptoms', 'Methods\n\n\nTwelve participants (11 females, 39.3 ± 13.9\u2009years) with HSD and shoulder instability and/or pain for more than 3\u2009months underwent a']","['Heavy shoulder strengthening exercise', '16-week heavy shoulder strengthening exercise programme three times weekly using exercises targeting scapular and rotator cuff muscles', 'shoulder strengthening exercise programme', 'shoulder strengthening programme']","['pre-defined research progression criteria including recruitment rate (acceptable, 6 participants/month), assessment duration (acceptable: < 120\u2009min), participant retention (acceptable: > 80% complete intervention), training adherence', 'Shoulder strength measurements', 'pain, kinesiophobia and fatigue', 'WOSI total score', 'Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse), self-reported pain, kinesiophobia and fatigue, isometric shoulder strength, besides clinical tests for instability, hypermobility, laxity, and proprioception', 'adverse events', 'short-lasting soreness or pain', 'shoulder laxity/instability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549185', 'cui_str': 'Hypermobility'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1959673', 'cui_str': 'Muscle of rotator cuff'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0549185', 'cui_str': 'Hypermobility'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",12.0,0.166366,"Shoulder strength measurements improved by 28-31% (mean change (95% CI), Nm/kg: scaption 0.51 (0.23, 0.78); internal rotation 1.32 (0.70, 1.95) and external rotation 0.89 (0.37, 1.40)), and clinical tests indicated decreased shoulder laxity/instability.
","[{'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Liaghat', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Søren T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Jørgensen', 'Affiliation': 'Orthopedic Research Unit, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sondergaard', 'Affiliation': 'Research Unit of General Practice, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Research Unit of Physical Activity and Health in Work Life, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Juul-Kristensen', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00632-y']
2801,32670627,Feasibility of implementing a novel behavioural smoking cessation intervention amongst human immunodeficiency virus-infected smokers in a resource-limited setting: A single-arm pilot trial.,"Background


Tobacco use is prevalent amongst individuals infected with human immunodeficiency virus (HIV). In resource-constrained settings, pharmacological smoking cessation interventions are unfeasible because of their high cost. There is a need to develop and evaluate behavioural interventions to address the unique challenges of tobacco use in the HIV-infected populations in these settings.
Objectives


The authors aimed to assess the feasibility and acceptability of the Behavioural Activation/Problem Solving for Smoking Cessation (BAPS-SC) intervention programme to determine whether it should be tested in an adequately powered randomised controlled trial.
Method


The authors merged behavioural activation therapy (BAT) with the principles of problem-solving therapy to create a novel five-session counselling model to address the unique challenges of tobacco cessation amongst those infected with HIV. Feasibility measures included the rate of enrolment amongst those eligible and the retention rate and descriptive analysis of intervention acceptability. The authors' secondary outcome was 7-day point smoking prevalence abstinence, confirmed with breath carbon monoxide.
Results


A total of 128 individuals were screened over 8 weeks with 50 deemed eligible and 40 enrolled (80%). Retention at week 12 was 53% (21/40). The 7-day point prevalence abstinence, co-confirmed, at week 12 was 37.5% (15/40). All respondents indicated that they would recommend BAPS-SC to other smokers who want to quit, and would be willing to participate in the programme again up to the point of exit if they did not stop smoking.
Conclusion


A full-scale randomised control trial comparing BAPS-SC with usual practice is warranted to evaluate the efficacy of this novel intervention in these settings.",2020,"The 7-day point prevalence abstinence, co-confirmed, at week 12 was 37.5% (15/40).","['individuals infected with human immunodeficiency virus (HIV', 'human immunodeficiency virus-infected smokers in a resource-limited setting', '128 individuals were screened over 8 weeks with 50 deemed eligible and 40 enrolled (80']","['BAPS-SC', 'behavioural activation therapy (BAT', 'implementing a novel behavioural smoking cessation intervention', 'Behavioural Activation/Problem Solving for Smoking Cessation (BAPS-SC) intervention programme']","['7-day point smoking prevalence abstinence, confirmed with breath carbon monoxide']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",128.0,0.104967,"The 7-day point prevalence abstinence, co-confirmed, at week 12 was 37.5% (15/40).","[{'ForeName': 'Billy M', 'Initials': 'BM', 'LastName': 'Tsima', 'Affiliation': 'Department of Family Medicine and Public Health, Faculty of Medicine, University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Precious', 'Initials': 'P', 'LastName': 'Moedi', 'Affiliation': 'Princess Marina Hospital, Dental Department, Gaborone, Botswana.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Maunge', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kitso', 'Initials': 'K', 'LastName': 'Machangane', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Kgogwane', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Tebogo', 'Initials': 'T', 'LastName': 'Mudojwa', 'Affiliation': 'Botswana UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bastian', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Bilker', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine (ID), Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States of America.'}]",Southern African journal of HIV medicine,['10.4102/sajhivmed.v21i1.1075']
2802,32670715,Validation of an Age-Appropriate Screening Tool for Female Athlete Triad and Relative Energy Deficiency in Sport in Young Athletes.,"Background The purpose of this study was to determine the concurrent validity of a newly created relative energy deficiency in sport (RED-S) specific screening tool (RST) by comparing scores with the validated pre-participation gynecological examination (PPGE). We hypothesized that the investigators would observe no significant difference between the means of the RST and the PPGE survey. Methods This was a crossover study of 39 female subjects who completed both the RST and the PPGE. The survey order was randomized. Results The RST was validated compared with the PPGE (Pearson's  r  = 0.697,  p  < 0.001). Conclusion The administration of an RST to middle- and high-school female athletes was validated compared with the PPGE. Formatting limitations of the screening tool were highlighted, leading to changes that improved the accuracy of the screening tool prior to application in a clinical setting. The RST is an age-appropriate screening tool that can be used by coaches, athletic trainers, physical therapists, and other healthcare practitioners to detect RED-S risk and allow for earlier intervention.",2020,"The RST was validated compared with the PPGE (Pearson's  r  = 0.697,  p  < 0.001).","['Female Athlete Triad and Relative Energy Deficiency in Sport in Young Athletes', '39 female subjects who completed both the RST and the PPGE']","['RST', 'newly created relative energy deficiency in sport (RED-S) specific screening tool (RST']",[],"[{'cui': 'C1721053', 'cui_str': 'Female athlete triad'}, {'cui': 'C5197752', 'cui_str': 'RED-S Relative Energy Deficiency in Sport'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035934', 'cui_str': 'Rubinstein-Taybi syndrome'}, {'cui': 'C0200044', 'cui_str': 'Gynecologic examination'}]","[{'cui': 'C0035934', 'cui_str': 'Rubinstein-Taybi syndrome'}, {'cui': 'C5197752', 'cui_str': 'RED-S Relative Energy Deficiency in Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",[],39.0,0.0295157,"The RST was validated compared with the PPGE (Pearson's  r  = 0.697,  p  < 0.001).","[{'ForeName': 'Cassidy M', 'Initials': 'CM', 'LastName': 'Foley Davelaar', 'Affiliation': ""Orthopedics, Nemours Children's Health System, Orlando, USA.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Ostrom', 'Affiliation': 'Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Schulz', 'Affiliation': 'Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Trane', 'Affiliation': 'Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wolkin', 'Affiliation': 'Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Granger', 'Affiliation': 'Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, USA.'}]",Cureus,['10.7759/cureus.8579']
2803,32670960,"Mindful awareness for female dental students through yoga, motivational video, and a combination of two on stress reduction.","Objective


Assessment of the potential effect of yoga, motivational videos, and a combination of two on stress reduction in female dental students.
Methods


The current study design is a nonrandomized trial carried out among female dental students ( n  = 120). The selected subjects were allocated into three groups, namely, group A: yoga group assigned under a professional yoga instructor, group B: motivational video group, and group C: a combination of two (A and B) involving yoga sessions and motivational videos; following which formative examinations were carried out at 6 weeks which were referred to as stressor 1 and those carried out at 12 weeks were referred to as stressor 2. Using Spielberger's State-Trait Anxiety Inventory for Adults (STAI-A) recordings were measured at baseline, stressor 1, and stressor 2.
Results


There was a significant decrease in trait anxiety scores at both stressors in all the groups with a significant reduction in depression score from stressor 1 to 2 in group 1 and group 3 subjects. The significant decrease occurred in STAI-A scores in group 1 and group 3 subjects at both stressors ( P  < 0.001) with no change observed in group 2 subjects.
Conclusion


The present study is one of a kind and positively correlates yoga and motivational videos with stress reduction. Both of these interventions proved to be beneficiary for physical as well as mental health of study subjects.",2020,There was a significant decrease in trait anxiety scores at both stressors in all the groups with a significant reduction in depression score from stressor 1 to 2 in group 1 and group 3 subjects.,"['Adults ', 'female dental students', 'female dental students ( n  = 120']","['yoga group assigned under a professional yoga instructor, group B: motivational video group, and group C: a combination of two (A and B) involving yoga sessions and motivational videos', 'yoga, motivational videos']","['depression score', 'trait anxiety scores', 'STAI-A scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",,0.0146301,There was a significant decrease in trait anxiety scores at both stressors in all the groups with a significant reduction in depression score from stressor 1 to 2 in group 1 and group 3 subjects.,"[{'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia, Manav Rachna Dental College, Faridabad, Haryana, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Department of Orthodontics, Manav Rachna Dental College, Faridabad, Haryana, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Dhillon', 'Affiliation': 'Department of Oral Medicine and Radiology, ITS Dental College, Delhi Meerut Road, Muradnagar, Ghaziabad, India.'}, {'ForeName': 'Dhirja', 'Initials': 'D', 'LastName': 'Goel', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, School of Dental Sciences, Sharda University, Knowledge Park III, Greater Noida, UP, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Jha', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Patna Dental College and Hospital, Kankarbagh, Patna, Bihar, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Consultant Orthodontist, Major Amit Orthodontic Center, Kankarbagh, Patna, Bihar, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_1187_19']
2804,32670964,Comparative evaluation of salivary immunoglobulin a levels between pedodontic subjects.,"Background and Aims


Host immune response is altered by a series of physiologic and pathologic factors like age, gender, inflammation, surgery, medication etc., The present study was conducted to evaluate differences in salivary IgA (S-IgA) levels among pedodontic subjects undergoing active orthodontic treatment with fixed and removable appliance. The levels of S- IgA were determined before 3 months and 6 months post active orthodontic treatment.
Methods


A total of 40 healthy pedodontic subjects (aged 8-15 years) were recruited in the present study. They were equally divided into Group A (fixed orthodontic group) and Group B (removable orthodontic group) with 20 subjects each. 1.5 mL of saliva per subject was obtained before 3 and 6 months after treatment. Enzyme Linked Immunosorbent Assay (ELISA) technique was used for measurement of Salivary IgA levels.
Results


Group A and B both showed significant rise in S-IgA levels 3 months and 6 months post active orthodontic treatment. Mean value of S-IgA 3 months post treatment in the saliva of children in group B and group A were (144.27 ± 5.32) and (164.0 ± 3.23) μg/ml respectively. While mean value of S-IgA after 6 months of treatment in group B and group A were (149.8 ± 6.02) and (166.4 ± 3.65) μg/ml respectively.
Conclusion


Salivary Immunoglobulin A level values were significantly higher statistically in both group A and group B post active orthodontic treatment than before. The results however, showed that Group A (fixed orthodontic group) showed statistically significant higher levels of S-IgA than Group B (removable orthodontic group). Active orthodontic treatment triggered a stronger stimulus for oral secretory immunity, hence the increase in levels were detected. There is a significant positive correlation between S-IgA and active fixed as well as removable orthodontic treatment. Orthodontic treatment is hence a local immunogenic factor.",2020,"The results however, showed that Group A (fixed orthodontic group) showed statistically significant higher levels of S-IgA than Group B (removable orthodontic group).","['pedodontic subjects undergoing active orthodontic treatment with fixed and removable appliance', 'pedodontic subjects', '40 healthy pedodontic subjects (aged 8-15 years']","['Enzyme Linked Immunosorbent Assay (ELISA) technique', 'Salivary Immunoglobulin']","['salivary IgA (S-IgA) levels', 'S-IgA levels', 'levels of S- IgA', 'levels of S-IgA']","[{'cui': 'C0030763', 'cui_str': 'Pediatric dentistry'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443735', 'cui_str': 'Salivary immunoglobulin A'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1277748', 'cui_str': 'Salivary IgA measurement'}]",40.0,0.0396321,"The results however, showed that Group A (fixed orthodontic group) showed statistically significant higher levels of S-IgA than Group B (removable orthodontic group).","[{'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Jha', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Prosthodontics Crown Bridge and Implantology, Patna Dental College, Patna, Bihar, India.'}, {'ForeName': 'Sovendu', 'Initials': 'S', 'LastName': 'Jha', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Buddha Institute of Dental Sciences and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Oral Medicine and Radiology, Patna, Bihar, India.'}, {'ForeName': 'Riddhi', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Penang International Dental College, Malaysia.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Prakash', 'Affiliation': 'MMR Dental Clinic, Swasthya Vihar, New Delhi, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_967_19']
2805,32670991,The Comparison of HHHFNC and NCPAP in Extremely Low-Birth-Weight Preterm Infants After Extubation: A Single-Center Randomized Controlled Trial.,"Objectives:  To compare the clinical efficacy of heated, humidified high-flow nasal cannula (HHHFNC) and nasal continuous positive airway pressure (NCPAP) in extremely low-birth-weight preterm infants (ELBWI) after extubation.  Methods:  This trial included 94 extremely low-birth-weight infants (ELBWI), within 7 days after birth, and prepared for tracheal extubation and a change to non-invasive ventilation in the neonatal intensive care unit (NICU) admitted to our hospital from January 2015 to December 2018, with 48 infants in the HHHFNC group and 46 infants in the NCPAP group. Reintubation rate within 72 h after initial extubation, total ventilation time, non-invasive ventilation time, total oxygen inhalation time, and the time to reach full enteral feeding were the primary outcome measures. Total intestinal feeding time, average weight gain rate, days of hospitalization, costs of hospitalization, and complication rates, including nasal injury, IVH, BPD, NEC, ROP, and PDA, were used as secondary outcomes. Data were analyzed using Student's  t -test or the Mann-Whitney  U -test with a Chi-square test or Fisher's exact test, as appropriate, in SPSS (25.0).  Results:  HHHFNC not only shortened the oxygen exposure time but also effectively reduced the incidence of nasal injury (6.25 vs. 36.96%) and NEC (10.42 vs. 28.26%) ( P  < 0.05). Additionally, HHHFNC achieved a significant advance in the time to reach full enteral feeding (31.24 ± 11.35 vs. 34.21 ± 14.09 days); increased the average weight gain rate (16.07 ± 3.10 vs. 13.74 ± 4.21) and reduced the days of hospitalization (73.45 ± 18.84 vs. 79.24 ± 19.75), with a lower cost of hospitalization (16.04 ± 3.64 vs.18.79 ± 4.13) thousand dollars (all  P  < 0.05).  Conclusions:  Compared with NCPAP, HHHFNC was effective in preventing extubation failure in mechanically ventilated preterm ELBWI. HHHFNC shortens oxygen consumption time and significantly reduces the incidence of nasal injury and necrotizing enterocolitis; moreover, it can also reduce the length of stay and the hospitalization costs.",2020,"HHHFNC shortens oxygen consumption time and significantly reduces the incidence of nasal injury and necrotizing enterocolitis; moreover, it can also reduce the length of stay and the hospitalization costs.","['extremely low-birth-weight preterm infants (ELBWI) after extubation', '94 extremely low-birth-weight infants (ELBWI), within 7 days after birth, and prepared for tracheal extubation and a change to non-invasive ventilation in the neonatal intensive care unit (NICU) admitted to our hospital from January 2015 to December 2018, with 48 infants in the HHHFNC group and 46 infants in the NCPAP group', 'Extremely Low-Birth-Weight Preterm Infants']","['HHHFNC', 'heated, humidified high-flow nasal cannula (HHHFNC) and nasal continuous positive airway pressure (NCPAP', 'HHHFNC and NCPAP', 'NCPAP']","['Reintubation rate', 'average weight gain rate', 'length of stay and the hospitalization costs', 'extubation failure', 'total ventilation time, non-invasive ventilation time, total oxygen inhalation time, and the time to reach full enteral feeding', 'days of hospitalization', 'Total intestinal feeding time, average weight gain rate, days of hospitalization, costs of hospitalization, and complication rates, including nasal injury, IVH, BPD, NEC, ROP, and PDA', 'incidence of nasal injury and necrotizing enterocolitis', 'time to reach full enteral feeding', 'incidence of nasal injury', 'cost of hospitalization', 'oxygen exposure time']","[{'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}]","[{'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0272427', 'cui_str': 'Injury of nose'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",94.0,0.0751656,"HHHFNC shortens oxygen consumption time and significantly reduces the incidence of nasal injury and necrotizing enterocolitis; moreover, it can also reduce the length of stay and the hospitalization costs.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Yingyi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Xiufang', 'Initials': 'X', 'LastName': 'Chi', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Yunbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, China.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00250']
2806,32671084,Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol.,"The severe respiratory distress syndrome linked to the new coronavirus disease (COVID-19) includes unbearable dyspneic suffering which contributes to the deterioration of the prognosis of patients in intensive care unit (ICU). Patients are put on mechanical ventilation to reduce respiratory suffering and preserve life. Despite this mechanical ventilation, most patients continue to suffer from dyspnea. Dyspnea is a major source of suffering in intensive care and one of the main factors that affect the prognosis of patients. The development of innovative methods for its management, especially non-drug management is more than necessary. In recent years, numerous studies have shown that transcranial direct current stimulation (tDCS) could modulate the perception of acute or chronic pain. In the other hand, it has been shown that the brain zones activated during pain and dyspnea are close and/or superimposed, suggesting that brain structures involved in the integration of aversive emotional component are shared by these two complex sensory experiences. Therefore, it can be hypothesized that stimulation by tDCS with regard to the areas which, in the case of pain have activated one or more of these brain structures, may also have an effect on dyspnea. In addition, our team recently demonstrated that the application of tDCS on the primary cortical motor area can modulate the excitability of the respiratory neurological pathways. Indeed, tDCS in anodal or cathodal modality reduced the excitability of the diaphragmatic cortico-spinal pathways in healthy subjects. We therefore hypothesized that tDCS could relieve dyspnea in COVID-19 patients under mechanical ventilation in ICU. This study was designed to evaluate effects of two modalities of tDCS (anodal and cathodal) vs. placebo, on the relief of dyspnea in COVID-19 patients requiring mechanical ventilation in ICU.  Trial Registration:  This protocol is derived from the tDCS-DYSP-REA project registered on ClinicalTrials.gov NCT03640455. It will however be registered under its own NCT number.",2020,"Indeed, tDCS in anodal or cathodal modality reduced the excitability of the diaphragmatic cortico-spinal pathways in healthy subjects.","['COVID-19 patients under mechanical ventilation in ICU', 'Mechanically Ventilated COVID-19 Patients in ICU', 'healthy subjects', 'COVID-19 patients requiring mechanical ventilation in ICU']","['transcranial direct current stimulation (tDCS', 'Low Intensity Transcranial Direct Current Stimulation (tDCS', 'tDCS', 'tDCS (anodal and cathodal) vs. placebo', 'mechanical ventilation']","['Dyspnea Relief', 'excitability of the diaphragmatic cortico-spinal pathways', 'relief of dyspnea', 'dyspnea', 'severe respiratory distress syndrome']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}]",,0.0755002,"Indeed, tDCS in anodal or cathodal modality reduced the excitability of the diaphragmatic cortico-spinal pathways in healthy subjects.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Azabou', 'Affiliation': 'Clinical Neurophysiology and Neuromodulation Unit, Departments of Physiology and Critical Care Medicine, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bao', 'Affiliation': 'Clinical Neurophysiology and Neuromodulation Unit, Departments of Physiology and Critical Care Medicine, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': 'General Intensive Care Unit-Assistance Publique Hôpitaux de Paris, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Bounab', 'Affiliation': 'General Intensive Care Unit-Assistance Publique Hôpitaux de Paris, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Moine', 'Affiliation': 'General Intensive Care Unit-Assistance Publique Hôpitaux de Paris, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Chevallier', 'Affiliation': 'Versailles Engineering Systems Laboratory (LISV), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Velizy, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': 'Service de Biostatistique et Information Médicale, AP-HP Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'Service de Biostatistique et Information Médicale, AP-HP Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Shidaps', 'Initials': 'S', 'LastName': 'Siami', 'Affiliation': 'Critical Care Medicine Unit, CH Etampes-Dourdan, Etampes, France.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sharshar', 'Affiliation': 'Department of Neuro-Intensive Care Medicine, Sainte-Anne Hospital, Paris-Descartes University, Paris, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Lofaso', 'Affiliation': 'Clinical Neurophysiology and Neuromodulation Unit, Departments of Physiology and Critical Care Medicine, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'General Intensive Care Unit-Assistance Publique Hôpitaux de Paris, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.'}]",Frontiers in medicine,['10.3389/fmed.2020.00372']
2807,32671129,Primed for Health: Future Thinking Priming Decreases Delay Discounting.,"Objective


Delay discounting, the propensity to devalue delayed rewards, has robust predictive validity for multiple health behaviors and is a new therapeutic target for health behavior change. Priming can influence behaviors in a predictable manner. We aimed to use the Future Thinking Priming task, administered remotely, to reliably decrease delay discounting rates.
Methods


In this pre-post randomized control group design, participants completed multiple delay discounting measures at baseline; then, 2 weeks later, they were randomized to Future Thinking Priming or Neutral Priming conditions. We hypothesized that Future Thinking Priming would significantly decrease delay discounting rates accounting for baseline delay discounting rates and time in repeated measures analyses.
Results


Participants randomized to Future Thinking Priming (N = 783) demonstrated significantly lower delay discounting rates post-intervention than those randomized to Neutral Priming (N = 747) on multiple delay discounting measures and magnitudes.
Conclusions


A single administration of Future Thinking Priming produces statistically reliable reductions in delay discounting rates. The task is brief, can be administered remotely, and is highly scalable. If found to support behavior change, the task might be disseminated broadly to enhance evidence-based behavior change interventions. Future research must determine optimal exposure patterns to support durable health behavior change.",2019,"Results


Participants randomized to Future Thinking Priming (N = 783) demonstrated significantly lower delay discounting rates post-intervention than those randomized to Neutral Priming (N = 747) on multiple delay discounting measures and magnitudes.
",[],['Future Thinking Priming or Neutral Priming conditions'],['delay discounting rates'],[],"[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}]",,0.049171,"Results


Participants randomized to Future Thinking Priming (N = 783) demonstrated significantly lower delay discounting rates post-intervention than those randomized to Neutral Priming (N = 747) on multiple delay discounting measures and magnitudes.
","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Shevorykin', 'Affiliation': 'Pace University, New York, NY.'}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Pittman', 'Affiliation': 'Wayne State University, Detroit, MI.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Advanced Recovery Research Center, Virginia Tech Carilion Research Institute, Roanoke, VA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'Connor"", 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'City University of New York Medical School, New York, NY.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Prashad', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Sheffer', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}]",Health behavior and policy review,['10.14485/hbpr.6.4.5']
2808,32675042,"Therapeutic drug monitoring study on the switch from coformulated 600-mg efavirenz, tenofovir disoproxil fumarate, and emtricitabine to coformulated 400-mg efavirenz, tenofovir disoproxil fumarate, and lamivudine among HIV-positive patients with viral suppression.","OBJECTIVES


This study evaluated the efavirenz (EFV) mid-dose plasma concentration (C12), clinical efficacy, and safety after the switch to a single-tablet regimen containing tenofovir disoproxil fumarate (TDF), lamivudine (3TC), and 400-mg EFV in virally suppressed HIV-positive Taiwanese who were receiving co-formulated TDF, emtricitabine (FTC), and 600-mg EFV.
METHODS


In this single-arm, open-label study, HIV-positive adults who had undetectable plasma HIV RNA load (<50 copies/ml) for 6 months or longer while receiving co-formulated TDF, FTC, and 600-mg EFV with EFV C12 of ≥1 mg/L were enrolled. The participants were switched to co-formulated TDF, 3TC, and 400-mg EFV and followed for 24 weeks. The primary endpoint was the proportion of participants with EFV C12 ≥ 1 mg/L at Week 4. The secondary endpoints included virologic response and change of CD4 lymphocyte count up to Week 24. Specific adverse effects associated with EFV were recorded before and after the switch.
RESULTS


From December 2018 to January 2019, 50 participants were enrolled. EFV C12 remained ≥1 mg/L in 48 (96.0%) participants with a median reduction of 38.9% (interquartile range 29.0-44.4) at Week 4 after switch. All participants had undetectable plasma HIV RNA by Week 12, whereas 96.0% of them remained so at Week 24. Significant increases of CD4 lymphocyte count were observed at Weeks 12 and 24. Thirty-three participants (66.0%) reported improvement of pre-existing adverse effects.
CONCLUSION


Switch to coformulated TDF, 3TC, and 400-mg EFV in virally suppressed HIV-positive Taiwanese maintained effective EFV concentration and viral suppression while the adverse effects were reduced.",2020,"All participants had undetectable plasma HIV RNA by Week 12, whereas 96.0% of them remained so at Week 24.","['HIV-positive adults who had undetectable plasma HIV RNA load (<50 copies/ml) for 6 months or longer while receiving co-formulated TDF, FTC, and 600-mg EFV with EFV C12 of ≥1\xa0mg/L were enrolled', 'From December 2018 to January 2019, 50 participants were enrolled', 'HIV-positive patients with viral suppression', 'virally suppressed HIV-positive Taiwanese who were receiving co-formulated']","['tenofovir disoproxil fumarate (TDF), lamivudine (3TC), and 400-mg EFV', 'TDF, 3TC, and 400-mg EFV', 'EFV C12', 'TDF, emtricitabine (FTC', 'efavirenz, tenofovir disoproxil fumarate, and emtricitabine to coformulated 400-mg efavirenz, tenofovir disoproxil fumarate, and lamivudine']","['efavirenz (EFV) mid-dose plasma concentration (C12), clinical efficacy, and safety', 'HIV-positive Taiwanese maintained effective EFV concentration and viral suppression', 'undetectable plasma HIV RNA', 'CD4 lymphocyte count', 'virologic response and change of CD4 lymphocyte count', 'proportion of participants with EFV C12', 'improvement of pre-existing adverse effects']","[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",50.0,0.126093,"All participants had undetectable plasma HIV RNA by Week 12, whereas 96.0% of them remained so at Week 24.","[{'ForeName': 'Wei-Chieh', 'Initials': 'WC', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chun-Kai', 'Initials': 'CK', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, I-Da Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Sung-Hsi', 'Initials': 'SH', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan; Department of Tropical Medicine and Parasitology, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Shu-Wen', 'Initials': 'SW', 'LastName': 'Lin', 'Affiliation': 'Department of Pharmacy, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; Graduate Institute of Clinical Pharmacy, National Taiwan University College of Medicine, Taipei, Taiwan; School of Pharmacy, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Shyh-Tyan', 'Initials': 'ST', 'LastName': 'Ou', 'Affiliation': 'Department of Statistics, National Taipei University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Ting', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ya-Wen', 'Initials': 'YW', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Wen-Chun', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Hsin-Yun', 'Initials': 'HY', 'LastName': 'Sun', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: hysun@ntu.edu.tw.'}, {'ForeName': 'Chien-Ching', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'Department of Tropical Medicine and Parasitology, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}]","Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi",['10.1016/j.jmii.2020.06.010']
2809,32675074,BCI training to move a virtual hand reduces phantom limb pain: A randomized crossover trial.,"OBJECTIVE


To determine whether training with a brain-computer interface (BCI) to control an image of a phantom hand, which moves based on cortical currents estimated from magnetoencephalographic signals, reduces phantom limb pain.
METHODS


Twelve patients with chronic phantom limb pain of the upper limb due to amputation or brachial plexus root avulsion participated in a randomized single-blinded crossover trial. Patients were trained to move the virtual hand image controlled by the BCI with a real decoder, which was constructed to classify intact hand movements from motor cortical currents, by moving their phantom hands for 3 days (""real training""). Pain was evaluated using a visual analogue scale (VAS) before and after training, and at follow-up for an additional 16 days. As a control, patients engaged in the training with the same hand image controlled by randomly changing values (""random training""). The 2 trainings were randomly assigned to the patients. This trial is registered at UMIN-CTR (UMIN000013608).
RESULTS


VAS at day 4 was significantly reduced from the baseline after real training (mean [SD], 45.3 [24.2]-30.9 [20.6], 1/100 mm;  p  = 0.009 < 0.025), but not after random training ( p  = 0.047 > 0.025). Compared to VAS at day 1, VAS at days 4 and 8 was significantly reduced by 32% and 36%, respectively, after real training and was significantly lower than VAS after random training ( p  < 0.01).
CONCLUSION


Three-day training to move the hand images controlled by BCI significantly reduced pain for 1 week.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that BCI reduces phantom limb pain.",2020,"Compared to VAS at day 1, VAS at days 4 and 8 was significantly reduced by 32% and 36%, respectively, after real training and was significantly lower than VAS after random training ( p  < 0.01).
",['Twelve patients with chronic phantom limb pain of the upper limb due to amputation or brachial plexus root avulsion participated'],"['VAS', 'training with a brain-computer interface (BCI', 'BCI', 'BCI training']","['phantom limb pain', 'visual analogue scale (VAS', 'Pain', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0457886', 'cui_str': 'Root of brachial plexus'}, {'cui': 'C0185044', 'cui_str': 'Surgical avulsion'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",12.0,0.0973384,"Compared to VAS at day 1, VAS at days 4 and 8 was significantly reduced by 32% and 36%, respectively, after real training and was significantly lower than VAS after random training ( p  < 0.01).
","[{'ForeName': 'Takufumi', 'Initials': 'T', 'LastName': 'Yanagisawa', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan. tyanagisawa@nsurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Fukuma', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Seymour', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hosomi', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Okito', 'Initials': 'O', 'LastName': 'Yamashita', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Kishima', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Yukiyasu', 'Initials': 'Y', 'LastName': 'Kamitani', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Saitoh', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}]",Neurology,['10.1212/WNL.0000000000009858']
2810,32675229,Safety decision-making and planning mobile app for intimate partner violence prevention and response: randomised controlled trial in Kenya.,"INTRODUCTION


Intimate partner violence (IPV) threatens women's health and safety globally, yet services remain underdeveloped and inaccessible. Technology-based resources exist, however, few have been adapted and tested in low-resource settings. We evaluate the efficacy of a community-partnered technology solution: culturally and linguistically adapted version of the myPlan app, a tailored safety decision-making and planning intervention, administrated by trained lay professionals.
METHODS


This randomised, controlled, participant-blinded superiority trial compares safety-related outcomes at baseline, immediate post intervention and 3-month follow-up among women at risk of and experiencing IPV in Nairobi, Kenya. Women were randomised (1:1 ratio) to: (1) myPlan Kenya (intervention); or (2) standard IPV referrals (control). Primary outcomes were safety preparedness, safety behaviour and IPV; secondary outcomes include resilience, mental health, service utilisation and self-blame.
RESULTS


Between April 2018 and October 2018, 352 participants (n=177 intervention, n=175 control) were enrolled and randomly assigned; 312 (88.6%, n=157 intervention, n=155 control) were retained at 3 months. Intervention participants demonstrated immediate postintervention improvement in safety preparedness relative to control participants (p=0.001). At 3 months, intervention participants reported increased helpfulness of safety strategies used relative to control participants (p=0.004); IPV reduced in both groups. Among women reporting the highest level of IPV severity, intervention participants had significant increase in resilience (p<0.01) compared with controls, and significantly decreased risk for lethal violence (p<0.01).
CONCLUSIONS


Facilitated delivery of a technology-based safety intervention appropriately adapted to the context demonstrates promise in improving women's IPV-related health and safety in a low-resource, urban setting.
TRIAL REGISTRATION NUMBER


Pan African Clinical Trial Registry (PACTR201804003321122).",2020,Intervention participants demonstrated immediate postintervention improvement in safety preparedness relative to control participants (p=0.001).,"['women at risk of and experiencing IPV in Nairobi, Kenya', 'Between April 2018 and October 2018, 352 participants (n=177 intervention, n=175 control) were enrolled and randomly assigned; 312 (88.6%, n=157 intervention, n=155 control']","['community-partnered technology solution', 'myPlan Kenya (intervention); or (2) standard IPV referrals (control']","['immediate postintervention improvement in safety preparedness', 'risk for lethal violence', 'IPV', 'safety preparedness, safety behaviour and IPV; secondary outcomes include resilience, mental health, service utilisation and self-blame', 'helpfulness of safety strategies']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517706', 'cui_str': '312'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",,0.174925,Intervention participants demonstrated immediate postintervention improvement in safety preparedness relative to control participants (p=0.001).,"[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Decker', 'Affiliation': 'Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA mdecker@jhu.edu.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Wood', 'Affiliation': 'Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Hameeduddin', 'Affiliation': 'Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'S Rachel', 'Initials': 'SR', 'LastName': 'Kennedy', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tallam', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Akumu', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Wanjiru', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Asira', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Frankel', 'Affiliation': 'International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Omondi', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Clough', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Mwiti', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}]",BMJ global health,['10.1136/bmjgh-2019-002091']
2811,32675261,"Effects of Implementing a Comprehensive Opioid Reduction Protocol on Overall Opioid Prescribing Among Patients with Chronic, Non-Cancer Pain in a Rural Family Medicine Clinic: A Controlled Cross-over Trial.","BACKGROUND


The opioid crisis presents many challenges for family practice providers in rural communities who treat patients with chronic non-cancer pain (CNCP). Unfortunately, evidence for effective opioid reduction strategies is sparse. We evaluated the effects of implementing a comprehensive opioid reduction protocol on overall opioid prescribing among patients with chronic non-cancer pain in our rural family medicine clinics.
METHODS


We compared mean daily milligrams morphine equivalent (MME) prescribed to patients with CNCP in our rural family medicine clinic (n = 93) with another matched clinic (n =93) after implementation of our comprehensive protocol. We also compared mean daily MME prescribed to our patients with CNCP before and after implementation of the protocol. In a subsequent cross over phase, we examined the effects of the protocol when applied to the original control group patients.
RESULTS


Mean daily MME in the intervention clinic (29.77) was significantly lower than the control clinic (93.2) after the intervention (t = 6.03;  P  < .00). Mean daily MME in the intervention group was significantly lower after implementation of the protocol (29.77) than before the protocol (MME 80.34) (t = 5.889;  P  < .00). After crossover, the mean daily MME was significantly lower (14.34) in the original control group than prior to the cross over intervention (85.68); (t = 8.19;  P  = .00).
DISCUSSION


Our comprehensive opioid reduction protocol led to significant reductions in opioid prescribing in our rural family medicine clinics. Future studies should include important qualitative outcome measures such as patient function.",2020,Mean daily MME in the intervention group was significantly lower after implementation of the protocol (29.77) than before the protocol (MME 80.34) (t = 5.889;  P  < .00).,"['rural communities who treat patients with chronic non-cancer pain (CNCP', 'patients with chronic non-cancer pain in our rural family medicine clinics', 'patients with CNCP in our rural family medicine clinic (n = 93) with another matched clinic (n =93) after implementation of our comprehensive protocol', 'Patients with Chronic, Non-Cancer Pain in a Rural Family Medicine Clinic']","['morphine equivalent (MME', 'comprehensive opioid reduction protocol', 'Comprehensive Opioid Reduction Protocol']","['mean daily MME', 'Mean daily MME', 'Overall Opioid Prescribing']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C3833703', 'cui_str': 'Family medicine clinic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]",93.0,0.016234,Mean daily MME in the intervention group was significantly lower after implementation of the protocol (29.77) than before the protocol (MME 80.34) (t = 5.889;  P  < .00).,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stack', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma. matthew.stack@midmichigan.org.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'LaRouche', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Yezi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Warden', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Stack', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Egle A', 'Initials': 'EA', 'LastName': 'Klugiene', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2020.04.200060']
2812,32675432,Combining neurofeedback with source estimation: Evaluation of an sLORETA neurofeedback protocol for chronic tinnitus treatment.,"BACKGROUND


Alpha/delta neurofeedback has been shown to be a potential treatment option for chronic subjective tinnitus. Traditional neurofeedback approaches working with a handful of surface electrodes have been criticized, however, due to their low spatial specificity.
OBJECTIVE


The purpose of this study was to evaluate an innovative tomographic neurofeedback protocol that combines neural activity measured across the whole scalp with sLORETA source estimation.
METHODS


Forty-eight tinnitus patients participated in 15 neurofeedback training sessions as well as extensive pre, post, and follow-up testing. Patients were randomly assigned to either a tomographic (TONF) or a traditional electrode-based neurofeedback (NTNF) group. Main outcome measures of this study were defined as tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and resting-state EEG activity in trained frequency bands.
RESULTS


For both groups a significant reduction of tinnitus-related distress and tinnitus loudness was found. While distress changes remained persistent irrespective of group, loudness levels returned to baseline in the follow-up period. No significant between-group differences between the 2 neurofeedback applications (TONF vs. NTNF) were found, which suggests a similar contribution to symptom improvement. The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period. This effect was found irrespective of group on both surface and source levels with no meaningful differences between the 2 groups.
CONCLUSIONS


Our study shows that a tomographic alpha/delta protocol should be considered a promising addition to tinnitus treatment but that more individually specific neurofeedback protocols should be developed.",2020,The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period.,"['chronic tinnitus treatment', 'Forty-eight tinnitus patients participated in 15']","['neurofeedback training sessions', 'tomographic (TONF) or a traditional electrode-based neurofeedback (NTNF']","['tinnitus-related distress and tinnitus loudness', 'trained alpha/delta ratio', 'tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and resting-state EEG activity in trained frequency bands', 'loudness levels']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",48.0,0.0426258,The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period.,"[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Güntensperger', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kleinjung', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neff', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thüring', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}]",Restorative neurology and neuroscience,['10.3233/RNN-200992']
2813,32675474,Characterization of resting and exercise inter-arm differences in SBP to isometric handgrip exercise in males and females.,"A large inter-arm difference (IAD; ≥10 mmHg) in SBP is linked to cardiovascular and peripheral vascular disease, hypertension, and premature mortality. Exercise-induced IAD (eIAD) is related to resting IAD, and acute aerobic activity alters eIAD and reduces IAD in recovery. Isometric handgrip exercise (IHE) affects blood pressure (BP), though the eIAD response to IHE is unknown. Further, the eIAD response may differ between males and females.
OBJECTIVES


To characterize the eIAD response to IHE in males and females.
METHODS


On visit 1, participants (16 females and 15 males, aged 18-35 years) completed three maximal voluntary isometric contractions (MVIC) per arm. On visit 2, before IHE, a series of three simultaneous, bilateral BP measures were averaged at rest. During IHE, participants maintained handgrip at 20% of MVIC for 2 minutes (arm randomly assigned), at which time bilateral BP was measured (IHE) during exercise and subsequent recovery (REC1 and REC2). Repeated-measures analysis of variance assessed eIAD and SBP (time × sex).
RESULTS


IHE increased absolute eIAD (4 mmHg). Differences in relative eIAD were observed at IHE and REC2 based on resting IAD status (P < 0.05). Females only had an exaggerated SBP and pulse pressure response in the working arm.
CONCLUSION


Acute IHE was shown to augment eIAD. Further eIAD and resting IAD were related. Acute IHE induced different bilateral responses between males and females, though the impact of sex on eIAD warrants further investigation. Future studies should address the effects of repeated bouts of IHE, which may benefit individuals with a large resting IAD.",2020,Differences in relative eIAD were observed at IHE and REC2 based on resting IAD status (P < 0.05).,"['participants (16 females and 15 males, aged 18-35 years', 'males and females']","['Isometric handgrip exercise (IHE', 'isometric handgrip exercise', 'maximal voluntary isometric contractions (MVIC', 'Exercise-induced IAD (eIAD']","['relative eIAD', 'absolute eIAD', 'bilateral BP measures', 'resting IAD status', 'blood pressure (BP', 'eIAD and SBP (time × sex', 'bilateral responses', 'exaggerated SBP and pulse pressure response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022230', 'cui_str': 'Inosine Pranobex'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022230', 'cui_str': 'Inosine Pranobex'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",,0.0394639,Differences in relative eIAD were observed at IHE and REC2 based on resting IAD status (P < 0.05).,"[{'ForeName': 'Brock T', 'Initials': 'BT', 'LastName': 'Jensen', 'Affiliation': 'Department of Exercise and Rehabilitative Sciences, Slippery Rock University, Slippery Rock, Pennsylvania, USA.'}, {'ForeName': 'Benjamin D H', 'Initials': 'BDH', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'Lance S', 'Initials': 'LS', 'LastName': 'Neuscheler', 'Affiliation': ''}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Ace', 'Affiliation': ''}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Borland', 'Affiliation': ''}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Holmstrup', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000465']
2814,32675475,Postural blood pressure changes in the elderly: orthostatic hypotension and hypertension.,"OBJECTIVES


Orthostatic hypotension is a well-known disorder, but orthostatic hypertension (OHT) still remains unclear in older adults. The aim of this study was to determine the comparison orthostatic hypotension with OHT according to fall risk and geriatric assessment parameters.
METHODS


A total of 741 patients who were admitted to the geriatric clinic and underwent comprehensive geriatric assessment were reviewed. Orthostatic blood pressure changes were measured by head-up-tilt Table test within the first three minutes. Orthostatic hypotension was defined as 20 or 10-mmHg drop in systolic and/or diastolic blood pressure from supine to standing position. OHT was defined as an increase in systolic blood pressure of 10 mmHg or more while the patient was standing up from the supine position.
RESULTS


The mean age was 75 ± 8 and 65. About 65% of all participants were female. The rate of orthostatic hypotension and OHT was 17.3 and 7.2%, respectively. The falls and dementia were more frequent, and the Instrumental Activities of Daily Living (IADL) score was lower in orthostatic hypotension group than in OHT and control groups (P < 0.05). These variables were similar between OHT and control groups (P > 0.05). The rates of falls [odds ratio (OR) = 2.02; 95% confidence interval (CI), (0.94-4.33); P = 0.044] and dementia [OR = 2.65; 95% CI, (1.08-6.48); P = 0.032] in orthostatic hypotension group were still higher than in OHT group, even after adjusting for age, sex, estimated glomerular filtration rate and drugs.
CONCLUSION


Orthostatic hypotension may be more significant in terms of falls, dementia and impaired IADLs scores in older adults than in OHT and control groups. It seems that OHT may be of no clinical importance in geriatric practice.",2020,"The falls and dementia were more frequent, and the Instrumental Activities of Daily Living (IADL) score was lower in orthostatic hypotension group than in OHT and control groups (P < 0.05).","['elderly: orthostatic hypotension and hypertension', 'The mean age was 75\u2009±\u20098 and 65', 'older adults', '741 patients who were admitted to the geriatric clinic and underwent comprehensive geriatric assessment were reviewed', 'older adults than in OHT and control groups']",[],"['rates of falls [odds ratio', 'Instrumental Activities of Daily Living (IADL) score', 'Postural blood pressure changes', 'orthostatic hypotension', 'Orthostatic blood pressure changes', 'Orthostatic hypotension', 'systolic blood pressure', 'falls and dementia', 'systolic and/or diastolic blood pressure', 'rate of orthostatic hypotension and OHT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0555968', 'cui_str': 'Elderly assessment clinic'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}]",741.0,0.0233568,"The falls and dementia were more frequent, and the Instrumental Activities of Daily Living (IADL) score was lower in orthostatic hypotension group than in OHT and control groups (P < 0.05).","[{'ForeName': 'Suleyman Emre', 'Initials': 'SE', 'LastName': 'Kocyigit', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Neziha', 'Initials': 'N', 'LastName': 'Erken', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Dokuzlar', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Fatma Sena', 'Initials': 'FS', 'LastName': 'Dost Gunay', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ates Bulut', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Ali Ekrem', 'Initials': 'AE', 'LastName': 'Aydin', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Soysal', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ahmet Turan', 'Initials': 'AT', 'LastName': 'Isik', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000466']
2815,32675553,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2020,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', 'FRS) Skills Curriculum', '12 international American College of Surgeons (ACS']","['Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'dV-Trainer', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.173584,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
2816,32671283,Enhancing vocational training in corrections: A type 1 hybrid randomized controlled trial protocol for evaluating virtual reality job interview training among returning citizens preparing for community re-entry.,"The Michigan Department of Corrections operates the Vocational Villages, which are skilled trades training programs set within prisons that include an immersive educational community using virtual reality, robotics, and other technologies to develop employable trades. An enhancement to the Vocational Villages could be an evidence-based job interview training component. Recently, we conducted a series of randomized controlled trials funded by the National Institute of Mental Health to evaluate the efficacy of virtual reality job interview training (VR-JIT). The results suggested that the use of VR-JIT was associated with improved job interview skills and a greater likelihood of receiving job offers within 6 months. The primary goal of this study is to report on the protocol we developed to evaluate the effectiveness of VR-JIT at improving interview skills, increasing job offers, and reducing recidivism when delivered within two Vocational Villages via a randomized controlled trial and process evaluation. Our aims are to: (1) evaluate whether services-as-usual in combination with VR-JIT, compared to services-as-usual alone, enhances employment outcomes and reduces recidivism among returning citizens enrolled in the Vocational Villages; (2) evaluate mechanisms of employment outcomes and explore mechanisms of recidivism; and (3) conduct a multilevel, mixed-method process evaluation of VR-JIT implementation to assess the adoptability, acceptability, scalability, feasibility, and implementation costs of VR-JIT.",2020,The results suggested that the use of VR-JIT was associated with improved job interview skills and a greater likelihood of receiving job offers within 6 months.,"['corrections', 'returning citizens preparing for community re-entry']","['virtual reality job interview training (VR-JIT', 'Enhancing vocational training', 'virtual reality job interview training', 'VR-JIT']","['job interview skills', 'adoptability, acceptability, scalability, feasibility, and implementation costs of VR-JIT']","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0204116', 'cui_str': 'Vocational training'}]","[{'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0382195,The results suggested that the use of VR-JIT was associated with improved job interview skills and a greater likelihood of receiving job offers within 6 months.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Smith', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Mitchell', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Blajeski', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Brittani', 'Initials': 'B', 'LastName': 'Parham', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Meghan M', 'Initials': 'MM', 'LastName': 'Harrington', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Ross', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Sinco', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Daphne M', 'Initials': 'DM', 'LastName': 'Brydon', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Johnson', 'Affiliation': 'Michigan State University Division of Public Health, East Lansing, MI, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Cuddeback', 'Affiliation': 'University of North Carolina at Chapel Hill School of Social Work, Chapel Hill, NC, USA.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Northwestern University Feinberg School of Medicine Department of Psychiatry and Behavioral Sciences, Chicago, IL, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Northwestern University Feinberg School of Medicine Department of Psychiatry and Behavioral Sciences, Chicago, IL, USA.'}, {'ForeName': 'Morris D', 'Initials': 'MD', 'LastName': 'Bell', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, West Haven, CT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McGeorge', 'Affiliation': 'Michigan Department of Corrections, Lansing, MI, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Kaminski', 'Affiliation': 'Michigan Department of Corrections, Lansing, MI, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Suganuma', 'Affiliation': ""Washtenaw County Sheriff's Office, Ann Arbor, MI, USA.""}, {'ForeName': 'Sheryl P', 'Initials': 'SP', 'LastName': 'Kubiak', 'Affiliation': 'Wayne State University School of Social Work, Detroit, MI, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100604']
2817,32671300,"Intravitreal Injections of Bevacizumab Plus Methotrexate versus Bevacizumab Alone for the Treatment of Diabetic Macular Edema: A Randomized, Sham-Controlled Trial.","Purpose


To evaluate the efficacy of intravitreal bevacizumab (IVB) combined with intravitreal methotrexate (IVM) in the treatment of diabetic macular edema (DME).
Methods


In this prospective, interventional contralateral eye study, patients with bilateral DME were randomly allocated to receive three monthly injections of IVB (1.25 mg/0.05 mL) plus IVM (400 μg; 0.16 cc) or IVB alone. The outcome measure was changes in the best corrected visual acuity (BCVA), central macular thickness (CMT), and central macular volume (CMV).
Results


Thirty-six treatment-naive eyes of 18 patients with a mean age of 62.38 ± 6.2 years were included in the study. BCVA logMAR changed from 0.95 ± 0.53 at baseline to 0.75 ± 0.53 in the combination group and from 0.72 ± 0.57 to 0.49 ± 0.50 in the IVB alone group at 1 month after the 3 rd  injection. BCVA improvement in both groups was not statistically significant compared with the baseline value ( P  > 0.99). Compared with the baseline values, mean CMT and CMV were reduced in both groups; however, these changes did not reach a significant level. The differences of CMT changes between the groups were not statistically significant at month 1 ( P  = 0.82), month 2 ( P  = 0.21), and month 3 ( P  = 0.10). Furthermore, the differences of CMV changes between the groups were not statistically significant at month 1 ( P  = 0.76), month 2 ( P  = 0.82), and month 3 ( P  = 0.11).
Conclusions


This pilot study demonstrated no significant therapeutic effects for IVB combined with IVM compared to IVB alone in treatment-naive DME patients over a 3-month course.",2020,"The differences of CMT changes between the groups were not statistically significant at month 1 ( P  = 0.82), month 2 ( P  = 0.21), and month 3 ( P  = 0.10).","['Diabetic Macular Edema', 'diabetic macular edema (DME', '6.2 years were included in the study', '18 patients with a mean age of 62.38 ±', 'patients with bilateral DME']","['IVB combined with IVM', 'IVB', 'Bevacizumab Alone', 'IVB alone', 'intravitreal bevacizumab (IVB) combined with intravitreal methotrexate (IVM', 'Bevacizumab Plus Methotrexate']","['mean CMT and CMV', 'CMV changes', 'BCVA logMAR', 'BCVA improvement', 'best corrected visual acuity (BCVA), central macular thickness (CMT), and central macular volume (CMV', 'CMT changes']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",18.0,0.047201,"The differences of CMT changes between the groups were not statistically significant at month 1 ( P  = 0.82), month 2 ( P  = 0.21), and month 3 ( P  = 0.10).","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Fazel', 'Affiliation': 'Department of Ophthalmology, Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Oliya', 'Affiliation': 'Department of Ophthalmology, Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mirmohammadkhani', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Fazel', 'Affiliation': 'Department of Ophthalmology, Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Yadegarfar', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Pourazizi', 'Affiliation': 'Department of Ophthalmology, Isfahan Eye Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of current ophthalmology,['10.4103/JOCO.JOCO_101_20']
2818,32671311,"Face, content, construct validity and training effect of touch surgery™ as a surgical decision-making trainer for novices in open appendicectomy.","Background


Laparoscopic surgery has become the gold standard for many operations with significant benefits in morbidity and hospital recovery time. One such procedure is appendicectomy, which is overwhelmingly performed using the laparoscopic approach in the modern era. This has also meant that the number of cases involving traditional open appendicectomy has declined despite surgeons being expected to be able to convert to the open technique if required. One method to rehearse for theatre is the use of software applications. This paper investigates the validity of Touch Surgery™ as an education tool for surgical decision-making for novices, as well as its training effect in open appendicectomy.
Method


70 participants will be recruited, consisting of 60 medical students (novices) and 10 surgical consultants (experts). For face, content, and construct validity, first attempt scores on the Touch Surgery™ Open Appendicectomy Test Module will be compared between novices and experts. For the training effect and knowledge decline elements of the study, novices will be further randomised into either the low intervention (control) group who will complete the simulation once, or to the high intervention group who will complete the simulation six times, with both novice groups asked to repeat the test one week later. All participants will also be requested to complete questionnaires regarding the stimulation.",2020,"For face, content, and construct validity, first attempt scores on the Touch Surgery™ Open Appendicectomy Test Module will be compared between novices and experts.","['70 participants will be recruited, consisting of 60 medical students (novices) and 10 surgical consultants (experts']",[],[],"[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}]",[],[],70.0,0.0196679,"For face, content, and construct validity, first attempt scores on the Touch Surgery™ Open Appendicectomy Test Module will be compared between novices and experts.","[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Lap Nicholas Tsang', 'Affiliation': 'Mackay Institute of Research and Innovation, QLD, Australia.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Surgery, Wollongong Hospital, NSW, Australia.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sugand', 'Affiliation': 'Faculty of Medicine, Department of Surgery & Cancer, Imperial College London, United Kingdom.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Chiu', 'Affiliation': 'Faculty of Medicine, University of Queensland, QLD, Australia.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Casper Pretorius', 'Affiliation': 'Mackay Institute of Research and Innovation, QLD, Australia.'}]",International journal of surgery protocols,['10.1016/j.isjp.2020.05.002']
2819,32671449,Effect of Tumescent Lidocaine and Epinephrine Infiltration on Blood Loss in Inferior Pedicle Wise-Pattern Breast Reduction: A Prospective Randomized Study.,"The idea of infiltrating epinephrine-containing solution in reduction mammoplasty with the aim of reducing blood loss dates back to 1985. Although its use is fairly common among surgeons, scientific evidence supporting such use has been feeble and inconsistent. Therefore, we aimed to investigate the effects of tumescent infiltration of lidocaine- and epinephrine-containing solution on blood loss in reduction mammoplasty. A prospective, randomized, double-blinded study is planned. Forty patients admitted to our clinic for mammary hypertrophy are randomly assigned to experiment and control groups, each of a size of 20 patients. Control group underwent conventional Wise-pattern, inferior pedicle breast reduction, whereas experiment group received tumescent fluid infiltration 20 min prior to making of the incisions. Data including age, body mass index (BMI), comorbidities, operative time, length of hospitalization along with preoperative, postoperative 2nd and 12th hour complete blood counts are recorded for each patient and compared between groups. Data analysis showed no significant difference between groups in terms of age, BMI, comorbidities or preoperative hematocrit levels. Operative time and hospitalization were significantly shorter in experiment group (p < 0.05*). The drop in hematocrit level in both the 2nd (4.93 ± 2.44% to 15.53 ± 7.17%) and 12th hour (9.4 ± 6.79 compared to 21.28 ± 10.15) was lower in the experiment group (p < 0.01*). A multiple variate analysis incorporating preoperative, postoperative 2nd and 12th hour hematocrit levels demonstrated a significant reduction in blood loss with the use of tumescent infiltration (Wilks' lambda F = 12.84, p < 0.01*). Multiple regression analysis revealed age, BMI, comorbidities, preoperative hematocrit levels and hospitalization did not affect postoperative blood loss (p > 0.05). Duration of operation, however, seemed to affect amount of blood loss postoperatively (p < 0.05*). With outcomes obtained from this study, it is clearly shown that tumescent infiltration significantly reduces blood loss in Wise-pattern, inferior pedicle breast reduction. Furthermore, tumescent infiltration is also shown to decrease operative time and length of hospital stay. EBM LEVEL II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,Operative time and hospitalization were significantly shorter in experiment group (p < 0.05*).,"['Forty patients admitted to our clinic for mammary hypertrophy', 'Inferior Pedicle Wise-Pattern Breast Reduction']","['lidocaine- and epinephrine-containing solution', 'epinephrine-containing solution', 'conventional Wise-pattern, inferior pedicle breast reduction, whereas experiment group received tumescent fluid infiltration 20\xa0min prior to making of the incisions', 'Tumescent Lidocaine and Epinephrine Infiltration']","['age, body mass index (BMI), comorbidities, operative time, length of hospitalization along with preoperative, postoperative 2nd and 12th hour complete blood counts', 'BMI, comorbidities, preoperative hematocrit levels and hospitalization', 'hematocrit level', 'operative time and length of hospital stay', 'age, BMI, comorbidities or preoperative hematocrit levels', 'postoperative blood loss', 'blood loss', 'Blood Loss', 'Operative time and hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0020565', 'cui_str': 'Hypertrophy of breast'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",40.0,0.0504864,Operative time and hospitalization were significantly shorter in experiment group (p < 0.05*).,"[{'ForeName': 'Alper Burak', 'Initials': 'AB', 'LastName': 'Uslu', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Karaman State Hospital, Universite Mahallesi 1984 Str. Number 1, 70200, Karaman, Turkey. dr.alperburakuslu@hotmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01859-z']
2820,32671481,Efficacy of denosumab co-administered with vitamin D and Ca by baseline vitamin D status.,"INTRODUCTION


In anti-osteoporosis drug trials, vitamin D and calcium (Ca) are common supplements; however, the optimal dose of each is unclear. Using data from the randomized, double-blind, placebo-controlled DIRECT trial, we assessed whether baseline serum 25-hydroxy vitamin D (25[OH]D) level influences the efficacy of denosumab co-administered with vitamin D and Ca.
MATERIALS AND METHODS


In this prespecified sub-analysis, subjects with primary osteoporosis who received denosumab or placebo, plus vitamin D (≥ 400 IU/day) and Ca (≥ 600 mg/day), were classified as 25(OH)D deficient (< 20 ng/mL), insufficient (≥ 20 to < 30 ng/mL), and sufficient (≥ 30 ng/mL). Study endpoints included absolute serum 25(OH)D level at baseline, 12 months, and 24 months; change in serum 25(OH)D and bone mineral density (BMD) status from baseline; and incidence of new vertebral fractures at 24 months.
RESULTS


In 475 denosumab-treated and 481 placebo-treated subjects, proportions with deficient/insufficient/sufficient 25(OH)D at baseline were 53.1%/37.1%/9.9% and 50.9%/42.0%/7.1%, respectively. Supplementation significantly increased mean serum 25(OH)D levels; at 24 months, mean levels were > 30 ng/mL (sufficient) in both treatment groups. Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups. At month 24, denosumab-treated subjects with deficient/insufficient baseline 25(OH)D had a significantly lower risk of new vertebral fracture vs. placebo-treated subjects.
CONCLUSION


Among DIRECT trial subjects supplemented with ≥ 400 IU/day of vitamin D and ≥ 600 mg/day of Ca, baseline 25(OH)D sufficiency may not influence the efficacy of denosumab in increasing BMD or preventing vertebral fractures.",2020,Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups.,['30'],"['vitamin D and calcium (Ca', 'denosumab or placebo, plus vitamin D', 'denosumab co-administered with vitamin D and Ca', 'vitamin D and\u2009≥', 'denosumab', 'denosumab co-administered with vitamin D and Ca by baseline vitamin D status', 'placebo']","['serum 25(OH)D and bone mineral density (BMD) status from baseline; and incidence of new vertebral fractures', 'mean serum 25(OH)D levels', 'absolute serum 25(OH)D level', 'risk of new vertebral fracture', 'BMD over time', 'baseline serum 25-hydroxy vitamin D (25[OH]D) level influences the efficacy']",[],"[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.404153,Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups.,"[{'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Eikokai Ono Hospital, Tenjincho 973, Ono City, Hyogo, 675-1316, Japan. sugimoto@med.shimane-u.ac.jp.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Kenkoin Clinic, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Okubo', 'Affiliation': 'Biostatistics & Data Management Department, R&D Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Takami', 'Affiliation': 'Development Function, R&D Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01119-9']
2821,32671515,A Cluster-Randomized Controlled Trial to Evaluate a Community-Based Healthy Eating and Nutrition Label Interpretation Intervention Among Latinx Immigrant Mothers and Their Daughters.,"We evaluated outcomes from a healthy eating/nutrition label interpretation intervention among Latinx immigrant mothers and their daughters, aged 9-12 years, in Alabama. Between May 2013-October 2017, this cluster randomized controlled trial assigned 299 mother-daughter dyads to either a healthy eating (intervention) or HPV vaccination (control) study arm. Participants attended four group sessions delivered in Spanish by Lay Health Educators covering portion sizes, healthy eating/cooking strategies, and nutrition label reading/interpretation. An individual session in participants' homes reviewed pantries and developed healthy eating plans. Identical interviewer-administered surveys were completed at baseline and 7-month follow-up by both study arms. Retention rate at follow-up was 93.4% in intervention arm (92.6% in control arm). Positive changes in healthy eating behaviors and proficiency in nutrition label interpretation were assessed. Adjusting for marital status, employment status, and health insurance coverage status, when compared to controls, mothers in the intervention arm had greater odds of increasing daily fruit and vegetable consumption (OR 3.66, 95% CI 2.14-6.27, p < 0.001), decreasing weekly fried food intake (OR 4.3, 95% CI 2.3-8.04, p < 0.001), decreasing daily sweetened beverages (OR 2.07, 95% CI 1.22-3.52, p < 0.01), increasing frequency of reading nutrition labels (OR 12.58, 95% CI 6.81-23.22, p < 0.001), and correctly interpreting nutrition labels (OR 4.45, 95% CI 2.64-7.48, p < 0.001). Significant positive changes in targeted behaviors were not observed among daughters. A community-based, culturally relevant intervention that includes nutrition label interpretation can positively influence eating habits among Latinx immigrant mothers.",2020,Retention rate at follow-up was 93.4% in intervention arm (92.6% in control arm).,"[""participants' homes reviewed pantries and developed healthy eating plans"", 'Latinx immigrant mothers', 'Latinx Immigrant Mothers and Their Daughters', '299 mother-daughter dyads to either a healthy eating (intervention) or HPV vaccination (control) study arm', 'Latinx immigrant mothers and their daughters, aged 9-12\xa0years, in Alabama']","['Community-Based Healthy Eating and Nutrition Label Interpretation Intervention', 'healthy eating/nutrition label interpretation intervention', 'Spanish by Lay Health Educators covering portion sizes, healthy eating/cooking strategies, and nutrition label reading/interpretation']","['daily fruit and vegetable consumption', 'marital status, employment status, and health insurance coverage status', 'correctly interpreting nutrition labels', 'targeted behaviors', 'decreasing daily sweetened beverages', 'eating habits', 'healthy eating behaviors and proficiency in nutrition label interpretation', 'Retention rate', 'frequency of reading nutrition labels', 'weekly fried food intake']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",299.0,0.107293,Retention rate at follow-up was 93.4% in intervention arm (92.6% in control arm).,"[{'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Scarinci', 'Affiliation': 'Division of Preventive Medicine, University of Alabama At Birmingham, 1717 11th Ave South, Birmingham, AL, 35205, USA. scarinci@uab.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'Division of Preventive Medicine, University of Alabama At Birmingham, 1717 11th Ave South, Birmingham, AL, 35205, USA.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'Division of Preventive Medicine, University of Alabama At Birmingham, 1717 11th Ave South, Birmingham, AL, 35205, USA.'}]",Journal of community health,['10.1007/s10900-020-00885-x']
2822,32671536,"The first management using intubation of a nasogastric tube with Gastrografin enterography or long tube for non-strangulated acute small bowel obstruction: a multicenter, randomized controlled trial.","BACKGROUND


Gastrointestinal decompression is generally applied to a non-strangulated acute small bowel obstruction (NSASBO). Although long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G) have shown advantages over NGT alone in previous studies, no studies appear to have compared LT and NGT-G.
METHODS


In this multicenter, randomized controlled trial, patients with NSASBO were randomly assigned to receive LT or NGT-G between July 2016 and November 2018 at 11 Japanese institutions. The primary endpoint was non-inferiority of NGT-G compared to LT for non-surgery rate, and the lower limit of the 95% confidence interval for the non-surgery rate (-15%) was set as the lower margin for inferiority of NGT-G compared to LT.
RESULTS


In total, 223 patients (LT group, n = 111; NGT-G group, n = 112) were analyzed in the present trial. The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923). On the other hand, the non-surgery rate with pure NGT-G alone (76.8%) that represents non-cross-over NGT-G without subsequent LT was significantly lower than that with LT (P = 0.039). Median procedure time was significantly shorter with NGT-G (1 min) than with LT (25 min; P < 0.001), whereas no significant differences in mortality or hospital stay were noted between groups.
CONCLUSION


NGT-G is an effective alternative to LT as a first-line treatment for NSASBO. A sequential strategy comprising NGT-G followed by LT might offer a new standard for NSASBO.
CLINICAL TRIALS REGISTRATION


This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (umin.ac.jp/ctr Identifier: UMIN000022669) prior to the start of this trial.",2020,"The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923).","['between July 2016 and November 2018 at 11 Japanese institutions', '223 patients (LT group, n\u2009=\u2009111; NGT-G group, n\u2009=\u2009112', 'patients with NSASBO', 'for non-strangulated acute small bowel obstruction']","['nasogastric tube with Gastrografin enterography or long tube', 'LT or NGT-G', 'long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G', 'NGT-G']","['non-surgery rate', 'mortality or hospital stay', 'non-inferiority of NGT-G', 'Median procedure time']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205362', 'cui_str': 'Strangulated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction'}]","[{'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0733796', 'cui_str': 'Gastrografin'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",223.0,0.14338,"The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923).","[{'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Katano', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. tshimura@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Hirotada', 'Initials': 'H', 'LastName': 'Nishie', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Iwai', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Itoh', 'Affiliation': 'Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Ebi', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Togawa', 'Affiliation': 'Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, 5-161 Maehata, Tajimi, 507-8522, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Gastroenterology, Gamagori City Hospital, 1-1 Mukaida, Hirata-cho, Gamagori, 443-8501, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nojiri', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sugiura', 'Affiliation': 'Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Matoya', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Nagura', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Koguchi', 'Affiliation': 'Department of Gastroenterology, Chukyo Hospital, 1-1-10 Sanjyo, Minami-ku, Nagoya, 457-8510, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ono', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Ozeki', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kataoka', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-020-01708-5']
2823,32671664,"An Investigation of the Skin Barrier Restoring Effects of a Cream and Lotion Containing Ceramides in a Multi-vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The RESTORE Study Phase 1.","INTRODUCTION


The replenishment of skin lipids depleted in the dry skin state is a desirable therapeutic target to restore skin moisturization; however, there is limited evidence demonstrating the success of this approach through the use of topical emollients. The purpose of this study was to provide evidence of the benefits of a cream and equivalent lotion containing skin lipids in a multi-vesicular emulsion for the management of dry skin. The hypothesis was that the test cream and test lotion could sustain skin moisturization for longer than traditional emollients by sustainably delivering skin lipids.
METHODS


A double-blind intra-subject vehicle-controlled single open-application test on the lower legs in people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted. There were six treatment sites, three per lower leg in each participant, which were treated with the test cream, the test lotion, three reference creams commonly prescribed in the UK and no treatment as a control. After baseline measurements of skin hydration, 100 μl of the test/reference creams was applied to each of the relevant treatment sites (random site allocation). Following treatment, measurements of skin hydration and scoring of visual dryness was conducted at timed intervals (3, 6, 12 and 24 h post-product application).
RESULTS


The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site. Compared to three reference emollient creams the test cream and test lotion were the only products capable of sustaining clinically meaningful improvements in skin moisturization for 24 h.
CONCLUSION


The sustained moisturization imparted by the test products reduces the need for frequent emollient application, often requiring 3-4 applications per day for traditional emollients, and should reduce the high burden of managing dry skin conditions like atopic dermatitis.",2020,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"['People with Dry, Eczema-Prone, Skin', 'people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted', 'dry skin']","['cream and equivalent lotion containing skin lipids', 'Cream and Lotion Containing Ceramides', 'double-blind intra-subject vehicle-controlled single open-application test']","['skin hydration and scoring of visual dryness', 'skin hydration and reduced skin dryness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]",,0.0643835,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"[{'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Danby', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK. s.danby@sheffield.ac.uk.'}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'Andrew', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chittock', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Kay', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}]",Dermatology and therapy,['10.1007/s13555-020-00426-3']
2824,32671684,"Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials.","INTRODUCTION


The efficacy of tiotropium/olodaterol compared with tiotropium in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated in a large clinical programme. Currently, randomised controlled trial (RCT) data on dual bronchodilation as first-line maintenance therapy are limited. In this post hoc analysis of pooled data from four RCTs, we compared the efficacy of tiotropium/olodaterol versus tiotropium as maintenance therapy in patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry.
METHODS


TONADO ®  1/2 (52 weeks) and OTEMTO ®  1/2 (12 weeks) were phase III RCTs in patients with COPD. TONADO 1/2 and OTEMTO 1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) < 80% predicted (lower limit FEV 1  ≥ 30% in OTEMTO 1/2 only). We examined the effect of tiotropium/olodaterol 5/5 µg versus tiotropium 5 µg on trough FEV 1  response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score at 12 weeks in four pooled studies.
RESULTS


The pooled analysis included 1078 maintenance-naïve patients. There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12. For patients receiving tiotropium/olodaterol, the odds of achieving a minimal clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 L, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) were higher versus tiotropium.
CONCLUSIONS


In patients who were maintenance naïve at baseline, treatment initiation with tiotropium/olodaterol resulted in greater improvements in lung function, health status and dyspnoea severity compared with tiotropium alone, without compromising patient safety. These results support the use of dual bronchodilation with tiotropium/olodaterol as first-line maintenance treatment in patients with COPD.
TRIAL REGISTRATION


ClinicalTrials.gov: TONADO ®  1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011) and OTEMTO ®  1 and 2 (NCT01964352 and NCT02006732, registered 14 October 2013).",2020,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","['1078 maintenance-naïve patients', 'patients with COPD', '1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1\xa0s (FEV 1 )\u2009<\u200980% predicted (lower limit FEV 1 \u2009≥\u200930% in OTEMTO\xa01/2 only', 'patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD']","['tiotropium/olodaterol\xa05/5\xa0µg versus tiotropium', 'ICS', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['lung function, health status and dyspnoea severity', 'SGRQ score', 'TDI score', ""trough FEV 1  response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score""]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",,0.220967,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg Universitat Mainz, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01411-0']
2825,32671930,Authors' reply re: Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial: The underestimated incidence of eclampsia in low-income countries: variation between regions.,,2020,,[],[],['Incidence and characteristics of pregnancy-related death'],[],[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.326366,,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16353']
2826,32671996,A feasibility study of a psycho-educational support intervention for men with prostate cancer on active surveillance.,"BACKGROUND


PROACTIVE is a psycho-educational support intervention for prostate cancer patients managed on Active Surveillance. PROACTIVE is composed of two interdependent components: group workshops and internet-delivered information modules.
AIMS


We conducted a feasibility study to determine the practicality of delivering PROACTIVE at two prostate cancer centres.
METHODS AND RESULTS


The feasibility study was a mixed-methods randomized parallel-group exploratory trial. Participants were randomised using a ratio of 3:1 PROACTIVE group to treatment as usual. Qualitative semi-structured interviews and quantitative measures were completed at baseline, intervention completion (week 6), and at 6-month follow-up. Interview transcripts were analysed thematically using Framework analysis. Descriptive statistics were used to examine recruitment and retention rates and changing trends in outcome measures. Most aspects of the research design and PROACTIVE intervention were acceptable to those participating in the study. In particular, participants valued the opportunity to share and discuss experiences with other prostate cancer patients on Active Surveillance and receive detailed authoritative information. However, three issues were identified: (a) a low response rate (13 participants recruited, response rate 16%), (b) low utilisation of internet delivered information modules, (c) self-perceived low levels of anxiety amongst participants with the majority perceiving their cancer as not impacting on their day-to-day life or causing anxiety.
CONCLUSIONS


Due to these significant research design issues, it is not recommended PROACTIVE be evaluated in a large-scale randomised controlled trial. Further research is required to explore the impact of Active Surveillance on anxiety amongst men with localized prostate cancer managed by Active Surveillance.",2020,Further research is required to explore the impact of Active Surveillance on anxiety amongst men with localized prostate cancer managed by Active Surveillance.,"['men with localized prostate cancer managed by Active Surveillance', 'men with prostate cancer on active surveillance', 'prostate cancer patients managed on Active Surveillance', 'at two prostate cancer centres', 'participants with the majority perceiving their cancer as not impacting on their day-to-day life or causing anxiety']",['psycho-educational support intervention'],['Interview transcripts'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",3.0,0.123868,Further research is required to explore the impact of Active Surveillance on anxiety amongst men with localized prostate cancer managed by Active Surveillance.,"[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Hughes', 'Affiliation': 'Royal London Hospital for Integrated Medicine, University College London Hospitals NHS Trust, London, UK.'}, {'ForeName': 'Geraldine M', 'Initials': 'GM', 'LastName': 'Leydon', 'Affiliation': 'Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Watts', 'Affiliation': 'Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy A', 'Initials': 'LA', 'LastName': 'Brindle', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Arden-Close', 'Affiliation': 'Department of Psychology, Bournemouth University, Poole, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bacon', 'Affiliation': 'Patient Representative, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Birch', 'Affiliation': 'University Hospital Southampton and School of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lallita', 'Initials': 'L', 'LastName': 'Carballo', 'Affiliation': 'Macmillan Support and Information Service, University College London Hospitals, London, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Plant', 'Affiliation': 'Macmillan Support and Information Service, University College London Hospitals, London, UK.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Moore', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lewith', 'Affiliation': 'Department of Primary Care, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Richardson', 'Affiliation': 'School of Health Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}]","Cancer reports (Hoboken, N.J.)",['10.1002/cnr2.1230']
2827,32672062,An Ex Vivo Study to Evaluate the Effect of Tegaserod on Platelet Activation and Aggregation.,"INTRODUCTION


Tegaserod, an orally active, potent 5-hydroxytryptamine-4 serotonin receptor agonist, was previously indicated for irritable bowel syndrome but was voluntarily withdrawn due to potential cardiovascular side effects. In vitro studies suggested that tegaserod increased platelet aggregation, but these results were not reproduced or were inconclusive. We sought to assess ex vivo effects of tegaserod on platelet aggregation.
METHODS


In this double-blind, placebo-controlled, crossover study, we randomized a majority of healthy patients with no history of cardiovascular risk factors (n = 21) to receive tegaserod or matching placebo for 7 + 2 days followed by a 7- to 10-day washout period, and then patients were crossed over to the other study drug for the next 7 + 2 days. Unstimulated and agonist-stimulated platelet aggregation; P-selectin expression; serum thromboxane (Tx)B 2  and urinary 11-dehydro (11-dh) TxB 2 ; and tegaserod and M29.0 concentrations were serially assessed.
RESULTS


There was no significant difference in percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression in the presence of tegaserod at any time point when compared to placebo. Similarly, there was no significant difference in percentage change in serum TxB 2  or urinary 11-dhTxB 2  levels between placebo and tegaserod. No new or unexpected findings were observed in evaluations of safety or pharmacokinetic parameters.
CONCLUSION


This comprehensive pharmacodynamic study, by employing established markers used in prior investigations, which have been considered by the Food and Drug Administration to indicate drug-related platelet effects, does not demonstrate any influence of tegaserod treatment on platelet function.",2020,"There was no significant difference in percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression in the presence of tegaserod at any time point when compared to placebo.",['healthy patients with no history of cardiovascular risk factors (n = 21'],"['tegaserod', 'tegaserod or matching placebo', 'placebo', 'Tegaserod']","['platelet aggregation', 'percentage change in serum TxB 2  or urinary 11-dhTxB 2  levels', 'percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression', 'Platelet Activation and Aggregation', 'thromboxane (Tx)B 2  and urinary 11-dehydro (11-dh) TxB 2 ; and tegaserod and M29.0 concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0537147', 'cui_str': 'tegaserod'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0252816', 'cui_str': 'thrombin receptor peptide SFLLRNP'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0040061', 'cui_str': 'Thromboxane'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0537147', 'cui_str': 'tegaserod'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0890886,"There was no significant difference in percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression in the presence of tegaserod at any time point when compared to placebo.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Sinai Center for Thrombosis Research, Sinai Hospital of Baltimore, LifeBridge Health, Baltimore, MD, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bliden', 'Affiliation': 'Sinai Center for Thrombosis Research, Sinai Hospital of Baltimore, LifeBridge Health, Baltimore, MD, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Barnett', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Witt', 'Affiliation': 'US WorldMeds LLC, Louisville, KY, USA.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zou', 'Affiliation': 'US WorldMeds LLC, Louisville, KY, USA.'}, {'ForeName': 'Udaya', 'Initials': 'U', 'LastName': 'Tantry', 'Affiliation': 'Sinai Center for Thrombosis Research, Sinai Hospital of Baltimore, LifeBridge Health, Baltimore, MD, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420942004']
2828,32672095,"Montmorency tart cherry juice does not reduce markers of muscle soreness, function and inflammation following professional male Rugby League match-play.","Rugby League (RL) match-play causes muscle damage, inflammation and symptoms of fatigue. To facilitate recovery, nutritional interventions are often employed, including Montmorency cherry juice (MC). We assessed the effects of MC on recovery following RL match-play in eleven male professional RL players who played in two matches (7-days apart) with MC or placebo (PLB) supplemented for 5-days pre-match, match day and 2-days post-match. Blood was collected 48h pre-match, half-time, within 30-mins of full-time and 48h post-match to assess Interleukin concentrations (IL-6, -8 -10). Self-reported sleep, fatigue, mood, stress, and muscle-soreness were assessed 24h pre and 24h and 48h post-matches with muscle function assessed 48h pre and 48h post-match. No differences in distance covered (6334±1944 Vs 6596±1776 m) and total collisions (28±11 Vs 29±13) were observed between both matches. There was a small albeit significant increase in IL-6, -8 and -10 concentrations pre to post-match in both PLB (IL-6: 0.83±0.92 Vs 2.91±1.40, IL-8: 2.16±1.22 Vs 3.91±1.61 and IL-10: 2.51±2.14 Vs 0.61±0.50 pg . mL -1 ) and MC groups (IL-6: 0.53±0.53 Vs 2.24±1.73, IL-8: 1.85±0.96 Vs 3.46±1.12 and IL-10: 0.48±0.50 Vs 2.54±2.10 pg . mL -1 ), although there were no significant differences between groups (P<0.05). Likewise, there was a small but significant increase in muscle soreness (P=0.01) alongside a reduction in CMJ (P=0.003) with no significant differences between groups. No significant changes in sleep, fatigue or mood (P>0.05) were observed pre to post-match or between groups. These data suggest MC does not affect the modest changes observed in cytokine responses and markers of recovery from professional RL match-play.",2020,"There was a small albeit significant increase in IL-6, -8 and -10 concentrations pre to post-match in both PLB (IL-6: 0.83±0.92 Vs 2.91±1.40, IL-8: 2.16±1.22 Vs 3.91±1.61 and IL-10: 2.51±2.14",['eleven male professional RL players who played in two matches (7-days apart) with'],"['MC', 'MC or placebo (PLB', 'IL-8']","['muscle soreness, function and inflammation', 'total collisions', 'sleep, fatigue or mood (P>0.05', 'Self-reported sleep, fatigue, mood, stress, and muscle-soreness', 'muscle soreness', 'Rugby League (RL) match-play causes muscle damage, inflammation and symptoms of fatigue', 'IL-6, -8 and -10 concentrations pre']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0982074', 'cui_str': 'CHERRY JUICE'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",11.0,0.159867,"There was a small albeit significant increase in IL-6, -8 and -10 concentrations pre to post-match in both PLB (IL-6: 0.83±0.92 Vs 2.91±1.40, IL-8: 2.16±1.22 Vs 3.91±1.61 and IL-10: 2.51±2.14","[{'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Morehen', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Warrington Wolves Rugby League Club, The Halliwell Jones Stadium, Mike Gregory Way, Warrington, UK.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Batsford', 'Affiliation': 'Warrington Wolves Rugby League Club, The Halliwell Jones Stadium, Mike Gregory Way, Warrington, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Barrow', 'Affiliation': 'Warrington Wolves Rugby League Club, The Halliwell Jones Stadium, Mike Gregory Way, Warrington, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Brown', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Stewart', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Morton', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Close', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1797181']
2829,32672145,Improving social-emotional competence in internationally adopted children with the Attachment and Biobehavioral Catch-up intervention.,"Children adopted internationally experience adverse conditions prior to adoption, placing them at risk for problematic social-emotional development. The Attachment and Biobehavioral Catch-up (ABC) intervention was designed to help internationally adoptive parents behave in ways that promote young children's social-emotional competence. Participants included 131 parent-child dyads randomly assigned to receive either ABC (n = 65) or a control intervention (n = 66). In addition, 48 low-risk biologically related parent-child dyads were included as a comparison group. At follow-up assessments conducted when children were 24 to 36 months old, internationally adopted children who received the ABC intervention had higher levels of parent-reported social-emotional competence than children who received a control intervention. In addition, observational assessments conducted when children were 48 and 60 months of age showed that internationally adopted children who received ABC demonstrated higher social-emotional competence than children who received a control intervention. Adopted children who received the control intervention, but not the ABC intervention, displayed more difficulties with social-emotional competence than low-risk children. Finally, postintervention parent sensitivity mediated the effect of ABC on observed child social-emotional competence in parent interactions, controlling for preintervention parent sensitivity. These results demonstrate the efficacy of a parenting-focused intervention in enhancing social-emotional competence among children adopted internationally.",2020,"Adopted children who received the control intervention, but not the ABC intervention, displayed more difficulties with social-emotional competence than low-risk children.","['48 low-risk biologically related parent-child dyads', 'Participants included 131 parent-child dyads']","['ABC', 'control intervention', 'Biobehavioral Catch-up (ABC) intervention', 'parenting-focused intervention', 'ABC intervention']","['higher levels of parent-reported social-emotional competence', 'social-emotional competence', 'child social-emotional competence', 'Improving social-emotional competence', 'difficulties with social-emotional competence']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1266852', 'cui_str': 'Blood relative'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}]",131.0,0.0190641,"Adopted children who received the control intervention, but not the ABC intervention, displayed more difficulties with social-emotional competence than low-risk children.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Psychiatry, University of California-San Diego, La Jolla, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lee Raby', 'Affiliation': 'Department of Psychology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychological Science, University of California-Irvine, Irvine, CA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Caron', 'Affiliation': 'Department of Psychological Science, Fitchburg State University, Fitchburg, MA, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wallin', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}]",Development and psychopathology,['10.1017/S0954579420000255']
2830,32675598,"Postoperative Single-shot Epidural Fentanyl and Bupivacaine for Postoperative Analgesia After Lumbar Decompression: A Prospective, Double-blind Randomized Study.","STUDY DESIGN


Randomized clinical trial.
OBJECTIVE


To evaluate the efficacy of the postoperative single-shot bolus of epidural Fentanyl and Bupivicaine in providing pain relief postlumbar decompression surgery.
SUMMARY OF BACKGROUND DATA


Despite lumbar decompression's success in alleviating symptoms of sciatica, radiculopathy, and neurogenic claudication, transient back and buttock pain has been a common complaint postoperatively. Providing good postoperative pain alleviation predicts patient's quality of recovery.
METHODS


We performed a randomized, double-blinded, clinical trial. Forty-five patients scheduled for lumbar decompression for a year's period who were randomly assigned to receive a postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution via an intraoperatively placed epidural catheter immediately after wound closure, before dressing application. Facial pain scale scores (from 0 to 10) were measured at three time points after surgery (fully awake at recovery room, transfer to ward, first postoperative day). Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge were also evaluated.
RESULTS


Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001). In turn, they also received less on-demand oral pain medications than those in the control group (P = 0.000). The mean time to ambulation was 0.09 days in the epidural group and 0.91 days in the decompression-alone group (P = 0.000). Criteria for hospital discharge were usually met on Day 0 in the epidural and Day 1 in the control group (P = 0.000). Within the study period, only one infection was noted in the epidural group which necessitated additional lumbar spine surgery (4.3%). No adverse events or complications related to Fentanyl use were observed.
CONCLUSIONS


A postoperative bolus of Fentanyl and Bupivacaine is effective in reducing early postoperative pain without the related complications of opiod administration.
LEVEL OF EVIDENCE


2.",2020,"RESULTS


Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","[""Forty-five patients scheduled for lumbar decompression for a year's period""]","['Postoperative Single-shot Epidural Fentanyl and Bupivacaine', 'Fentanyl and Bupivacaine', 'epidural Fentanyl and Bupivicaine', 'postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution']","['mean time to ambulation', 'Facial pain scale scores', 'Postoperative Analgesia', 'Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge', 'demand oral pain medications', 'early postoperative pain', 'additional lumbar spine surgery', 'Criteria for hospital discharge', 'Pain scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",45.0,0.505371,"RESULTS


Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","[{'ForeName': 'Mannuel Feliciano B', 'Initials': 'MFB', 'LastName': 'Alican', 'Affiliation': ""Institute of Orthopedics and Sports Medicine, St. Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Mario R', 'Initials': 'MR', 'LastName': 'Ver', 'Affiliation': ""Institute of Orthopedics and Sports Medicine, St. Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Miguel Rafael D', 'Initials': 'MRD', 'LastName': 'Ramos', 'Affiliation': ""Institute of Orthopedics and Sports Medicine, St. Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Lulu Joan C', 'Initials': 'LJC', 'LastName': 'Mamaril', 'Affiliation': ""Department of Anesthesiology, St. Luke's Medical Center, Quezon City, Philippines.""}]",Spine,['10.1097/BRS.0000000000003449']
2831,32675599,"The Titanium-coated PEEK Cage Maintains Better Bone Fusion With the Endplate Than the PEEK Cage 6 Months After PLIF Surgery: A Multicenter, Prospective, Randomized Study.","STUDY DESIGN


A multicenter, randomized, open-label, parallel-group trial.
OBJECTIVE


To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery.
SUMMARY OF BACKGROUND DATA


Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages.
METHODS


During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 yr) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography and assessed by modified intention-to-treat analysis in 149 cases and per-protocol analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index.
RESULTS


The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; P = 0.03) was independently associated with bone fusion at 6 months after surgery. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index results improved postoperatively in both groups.
CONCLUSION


Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage.
LEVEL OF EVIDENCE


1.",2020,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis.,"['149 patients (84 men, 65 women, mean age 67 yr']","['titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages', 'TiPEEK cage (n\u200a=\u200a69) or PEEK cage']","['interbody union rate', 'rates of bone fusion', 'Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index', 'Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index', 'bone fusion rates']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337189', 'cui_str': 'Cage'}]","[{'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",149.0,0.0990922,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis.,"[{'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ushirozako', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Ebata', 'Initials': 'E', 'LastName': 'Shigeto', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Mukaiyama', 'Affiliation': 'Department of Orthopedic Surgery, North Alps Medical Center Azumi Hospital, Kita Azumi, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shimizu', 'Affiliation': 'Department of Orthopedic Surgery, Narita Memorial Hospital, Aichi, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yamato', 'Affiliation': 'Department of Orthopedic Surgery and Division of Geriatric Musculoskeletal Health, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ojima', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}]",Spine,['10.1097/BRS.0000000000003464']
2832,32675601,Prosthesis in Anterior Cervical Herniated Disc Approach Does Not Prevent Radiologic Adjacent Segment Degeneration.,"STUDY DESIGN


Retrospective analysis using data from RCTs.
OBJECTIVE


This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis.
SUMMARY OF BACKGROUND DATA


Cervical disc prostheses were introduced to prevent ASD in the postsurgical follow-up. However, it is still a controversial issue.
METHODS


Two hundred fifty-three patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level.
RESULTS


Radiological ASD was present in 34% of patients at baseline and increased to 59% at 2-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
CONCLUSIONS


Radiological ASD occurs in a similar manner in patients who were subjected to arthrodesis in cervical radiculopathy and in patients who received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent.
LEVEL OF EVIDENCE


2.",2020,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","['Two hundred fifty-three patients', 'patients with cervical radiculopathy due to a herniated disc']","['anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD', 'cervical arthroplasty or arthrodesis']","['disc height', 'Progression of radiological ASD', 'Radiological ASD']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0442106', 'cui_str': 'Intervertebral'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3888829', 'cui_str': 'Adjacent segment degeneration'}]",253.0,0.151115,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Donk', 'Affiliation': 'Department of Orthopaedic Surgery, Via Sana Clinics, Mill, The Netherlands.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Arts', 'Affiliation': 'Department of Neurosurgery, Haaglanden Medical Centre, The Hague, The Netherlands.'}, {'ForeName': 'Ronald H M A', 'Initials': 'RHMA', 'LastName': 'Bartels', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Carmen L A', 'Initials': 'CLA', 'LastName': 'Vleggeert-Lankamp', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, Leiden, The Netherlands.'}]",Spine,['10.1097/BRS.0000000000003453']
2833,32675606,Effects of Specific Exercise Therapy on Adolescent Patients With Idiopathic Scoliosis: A Prospective Controlled Cohort Study.,"STUDY DESIGN


A prospective controlled cohort study.
OBJECTIVE


The aim of this study was to explore the interventional effect of exercise therapy on idiopathic scoliosis (IS) and identify an optimal intervention window.
SUMMARY OF BACKGROUND DATA


Early conservative treatment is helpful for IS. In addition to bracing, current evidence suggests that exercise can play an important role.
METHODS


We included 99 patients with IS who were treated at the Guangdong Xinmiao Scoliosis Center from August 2013 to September 2017. The inclusion criteria were: new IS diagnosis, Cobb angle 10° to 25°, Risser 0 to 3 grade, only treated with the Xinmiao treatment system (XTS; >3 days/week, >1 h/day), and follow-up >1 year. Patients were divided into three age groups: A, <10 years (n = 29); B, 10 to 12 years (n = 24); and C, 13 to 15 years (n = 46). The percentages of curve improvement (Cobb angle decrease ≥5°), stability (Cobb angle change × ±5°), and progression (Cobb angle increase ≥5°) were compared.
RESULTS


The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all P < 0.05). The major curve in group A decreased significantly by 6.8° (44% correction), compared to 3.1° (18% correction) and 1.5° (9% correction) in groups B and C, respectively. In group A, 69.0% (20/29) had curve improvement, 27.6% (8/29) stabilized and 3.4% (1/29) progressed. In group B, 45.8% (11/24) improved, 50% (12/24) stabilized, and 4.2% (1/24) progressed. In group C, 26.1% (12/46) improved, 63.0% (29/46) stabilized, and 10.9% (5/46) progressed. There was also a significant difference in final Risser grade among the groups (P < 0.05).
CONCLUSION


For IS patients with Cobb angles between 10° and 25°, our exercise protocol can effectively control or improve curve progression. Younger patients with a lower Risser grade are most likely to respond.
LEVEL OF EVIDENCE


2.",2020,"The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all P < 0.05).","['Younger patients with a lower Risser grade', 'The inclusion criteria were: new IS diagnosis, Cobb angle 10° to 25°, Risser 0 to 3 grade, only treated with the Xinmiao treatment system (XTS; >3\u200adays/week, >1\u200ah/day), and follow-up >1 year', '99 patients with IS who were treated at the Guangdong Xinmiao Scoliosis Center from August 2013 to September 2017', 'Adolescent Patients With Idiopathic Scoliosis']","['exercise therapy', 'Specific Exercise Therapy']","['final Risser grade', 'major curve correction, Risser sign, first referral, and final follow-up of the main curve', 'percentages of curve improvement (Cobb angle decrease ≥5°), stability (Cobb angle change × ±5°), and progression']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",99.0,0.0389948,"The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all P < 0.05).","[{'ForeName': 'Delong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, the 1st Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yunlin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Physical Education Institute, Chengdu University of Technology, Chengdu, China.'}, {'ForeName': 'Xuexiang', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of sports and Arts, Guangzhou Sport University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jingfan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Spine Center, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Xuan', 'Affiliation': 'Xinmiao Scoliosis Prevention Center of Guangdong Province, Guangzhou, Guangdong, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Spine Center, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zifang', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Spine Surgery, the 1st Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}]",Spine,['10.1097/BRS.0000000000003451']
2834,32675791,Gender Bias in Collaborative Medical Decision Making: Emergent Evidence.,"This initial, exploratory study on gender bias in collaborative medical decision making examined the degree to which physicians' reliance on a team member's patient care advice differs as a function of the gender of the advice giver. In 2018, 283 anesthesiologists read a brief, online clinical vignette and were randomly assigned to receive treatment advice from 1 of 8 possible sources (physician or nurse; man or woman; experienced or inexperienced). They then indicated their treatment decision, as well as the degree to which they relied upon the advice given.The results revealed two patterns consistent with gender bias in participants' advice taking. First, when treatment advice was delivered by an inexperienced physician, participants reported replying significantly more on the advice of a man versus a woman, F(1,61) = 4.24, P = .04. Second, participants' reliance on the advice of the woman physician was a function of her experience, F(1,62) = 6.96, P = .01, whereas reliance on the advice of the man physician was not, F(1,60) = 0.21, P = .65.These findings suggest women physicians, relative to men, may encounter additional hurdles to performing their jobs, especially at early stages in their careers. These hurdles are rooted in psychological biases of others, rather than objective features of cases or treatment settings. Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do social category membership. The authors recommend institutions adopt policies and practices encouraging equal attention to advice, regardless of the source, to help ensure advice taking is a function of information quality rather than the attributes of the advice giver. Such policies and practices may help surface and implement diverse expert perspectives in collaborative medical decision making, promoting better and more effective patient care.",2020,"Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do social category membership.","['In 2018, 283 anesthesiologists read a brief, online clinical vignette']",['treatment advice from 1 of 8 possible sources (physician or nurse; man or woman; experienced or inexperienced'],[],"[{'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],,0.0207179,"Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do social category membership.","[{'ForeName': 'Erik G', 'Initials': 'EG', 'LastName': 'Helzer', 'Affiliation': ""E.G. Helzer is associate professor, Naval Postgraduate School, Monterey, California. C.G. Myers is assistant professor, Johns Hopkins Carey Business School and Johns Hopkins School of Medicine, Baltimore, Maryland. C. Fahim is a scientist, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada. K.M. Sutcliffe is professor, Johns Hopkins Carey Business School and Johns Hopkins School of Medicine, Baltimore, Maryland, J.H. Abernathy is associate professor of anesthesiology and critical care medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.""}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Myers', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fahim', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sutcliffe', 'Affiliation': ''}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Abernathy', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003590']
2835,32676018,Anodal Transcranial Direct Current Stimulation Enhances Retention of Visuomotor Stepping Skills in Healthy Adults.,"Transcranial direct current stimulation (tDCS) paired with exercise training can enhance learning and retention of hand tasks; however, there have been few investigations of the effects of tDCS on leg skill improvements. The purpose of this study was to investigate whether tDCS paired with visuomotor step training can promote skill learning and retention. We hypothesized that pairing step training with anodal tDCS would improve skill learning and retention, evidenced by decreased step reaction times (RTs), both immediately (online skill gains) and 30 min after training (offline skill gains). Twenty healthy adults were randomly assigned to one of two groups, in which 20-min anodal or sham tDCS was applied to the lower limb motor cortex and paired with visuomotor step training. Step RTs were determined across three time points: (1) before brain stimulation (baseline); (2) immediately after brain stimulation (P0); and (3) 30 min after brain stimulation (P3). A continuous decline in RT was observed in the anodal tDCS group at both P0 and P3, with a significant decrease in RT at P3; whereas there were no improvements in RT at P0 and P3 in the sham group. These findings do not support our hypothesis that anodal tDCS enhances online learning, as RT was not decreased significantly immediately after stimulation. Nevertheless, the results indicate that anodal tDCS enhances offline learning, as RT was significantly decreased 30 min after stimulation, likely because of tDCS-induced neural modulation of cortical and subcortical excitability, synaptic efficacy, and spinal neuronal activity.",2020,"A continuous decline in RT was observed in the anodal tDCS group at both P0 and P3, with a significant decrease in RT at P3; whereas there were no improvements in RT at P0 and P3 in the sham group.","['Healthy Adults', 'Twenty healthy adults']","['Transcranial direct current stimulation (tDCS) paired with exercise training', 'tDCS paired with visuomotor step training', 'tDCS', 'anodal tDCS', 'Anodal Transcranial Direct Current Stimulation', 'visuomotor step training', '20-min anodal or sham tDCS', 'pairing step training with anodal tDCS']","['RT', 'skill learning and retention, evidenced by decreased step reaction times (RTs', 'learning and retention of hand tasks', 'RT at P3', 'tDCS-induced neural modulation of cortical and subcortical excitability, synaptic efficacy, and spinal neuronal activity', 'Visuomotor Stepping Skills']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",20.0,0.0238478,"A continuous decline in RT was observed in the anodal tDCS group at both P0 and P3, with a significant decrease in RT at P3; whereas there were no improvements in RT at P0 and P3 in the sham group.","[{'ForeName': 'Shih-Chiao', 'Initials': 'SC', 'LastName': 'Tseng', 'Affiliation': ""Neuroscience Laboratory, School of Physical Therapy, Texas Woman's University, Houston, TX, United States.""}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Chang', 'Affiliation': 'Motor Recovery Laboratory, Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Hoerth', 'Affiliation': ""Neuroscience Laboratory, School of Physical Therapy, Texas Woman's University, Houston, TX, United States.""}, {'ForeName': 'Anh-Tu A', 'Initials': 'AA', 'LastName': 'Nguyen', 'Affiliation': ""Neuroscience Laboratory, School of Physical Therapy, Texas Woman's University, Houston, TX, United States.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Perales', 'Affiliation': ""Neuroscience Laboratory, School of Physical Therapy, Texas Woman's University, Houston, TX, United States.""}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00251']
2836,32676043,Motor-Enriched Encoding Can Improve Children's Early Letter Recognition.,"It is not known how effective specific types of motor-enriched activities are at improving academic learning and early reading skills in children. The aim of this study was to investigate whether fine or gross motor enrichment during a single session of recognizing letters ""b""/""d"" can improve within-session performance or delayed retention the following day in comparison to letter recognition practice without movement. Furthermore, the aim was to investigate children's motivation to perform the specific tasks. We used a randomized controlled intervention study-design to investigate the effect of 10-min motor-enriched ""b""/""d"" letter training on children's ability to recognize the letters ""b"" and ""d"" ( n  = 127, mean age = 7.61 ± SD = 0.44 years) acutely, and in a delayed retention test. Three groups were included: a fine motor-enriched group (FME), a gross motor-enriched group (GME), that received 10 min of ""b"" and ""d"" training with enriched gestures (fine or gross motor movements, respectively), and a control group (CON), which received non motor-enriched ""b""/""d"" training. The children's ability to recognize ""b"" and ""d"" were tested before (T0), immediately after (T1), and one day after the intervention (T2) using a ""b""/""d"" Recognition Test. Based on a generalized linear mixed model a significant group-time interaction was found for accuracy in the ""b""/""d"" Recognition Test. Specifically, FME improved their ability to recognize ""b""/""d"" at post intervention (T0→T1,  p  = 0.008) and one-day retention test (T0→T2,  p  < 0.001) more than CON. There was no significant difference in change between GME and CON. For reaction time there were no significant global interaction effects observed. However, planned post hoc comparisons revealed a significant difference between GME and CON immediately after the intervention (T0→T1,  p  = 0.03). The children's motivation-score was higher for FME and GME compared to CON (FME-CON:  p  = 0.01; GME-CON:  p  = 0.01). The study demonstrated that fine motor-enriched training improved children's letter recognition more than non motor activities. Both types of motor training were accompanied by higher intrinsic motivation for the children compared to the non motor training group. The study suggests a new method for motor-enriched letter learning and future research should investigate the underlying mechanisms.",2020,The children's motivation-score was higher for FME and GME compared to CON (FME-CON:  p  = 0.01; GME-CON:  p  = 0.01).,"['children\'s ability to recognize the letters ""b"" and ""d"" ( n  = 127, mean age = 7.61 ± SD = 0.44 years) acutely, and in a delayed retention test', 'children']","['fine motor-enriched training', 'FME', '10-min motor-enriched ""b""/""d"" letter training', 'CON (FME-CON', 'fine motor-enriched group (FME), a gross motor-enriched group (GME), that received 10 min of ""b"" and ""d"" training with enriched gestures (fine or gross motor movements, respectively), and a control group (CON), which received non motor-enriched ""b""/""d"" training']","[""children's letter recognition"", 'intrinsic motivation', 'GME and CON', ""children's motivation-score""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517459', 'cui_str': '0.44'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0510785,The children's motivation-score was higher for FME and GME compared to CON (FME-CON:  p  = 0.01; GME-CON:  p  = 0.01).,"[{'ForeName': 'Linn', 'Initials': 'L', 'LastName': 'Damsgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sofie Rejkjær', 'Initials': 'SR', 'LastName': 'Elleby', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Kær', 'Initials': 'AK', 'LastName': 'Gejl', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie Bøgh', 'Initials': 'ASB', 'LastName': 'Malling', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bugge', 'Affiliation': 'Department of Midwifery, Physiotherapy, Occupational Therapy and Psychomotor Therapy, University College Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Lundbye-Jensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Wienecke', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01207']
2837,32671846,"Similar Pharmacokinetics of Three Dosing Regimens Comprising Two Oral Delayed-Release Mesalamine Formulations in Healthy Adult Volunteers: Randomised, Open-Label, Parallel-Group Study.","AIMS


Mesalamine is the first-line therapy for treating mild-to-moderate ulcerative colitis. Multiple mesalamine formulations are available, with similar safety and efficacy profiles. Mesalamine is commonly administered as divided dosing, although once-daily dosing may provide benefits for patients. We evaluated pharmacokinetics of three dosing regimens of two oral delayed-release mesalamine formulations in healthy adult volunteers.
METHODS


Randomised, open-label, parallel-group study of mesalamine pharmacokinetics following Lialda 2× 1.2 g once-daily [QD] (Dose A), Asacol 6× 400 mg QD [Dose B], or Asacol 2× 400 mg three-times-daily [TID] (Dose C), over 7 days. Assessments included 5-aminosalicylic acid [5-ASA] and N-acetyl 5-aminosalicylic acid [N-Ac-5-ASA; primary metabolite] pharmacokinetics [A e  (%), AUC 0-24  and C max  ], safety and tolerability.
RESULTS


All enrolled volunteers [N = 37] completed the study. Steady-state was achieved for all treatments by Day 4. Ratios (95% CI) of means for steady-state AUC 0-24  [Dose A vs B: 90.3% (39.8, 204.8); Dose A vs C: 123.5% (55.3, 275.7); Dose B vs C: 136.8% (61.3, 305.5)] and C max  [Dose A vs B: 106.0% (46.4, 242.2); Dose A vs C: 133.0% [59.1, 299.0]; Dose B vs C: 125.5% (55.8, 282.1)] were similar for all 5-ASA treatments. Mean urinary excretion of 5-ASA plus N-Ac-5-ASA was comparable between treatments [Dose A: 21.3%; Dose B: 20.2%; Dose C: 17.9%]. All treatment regimens were well tolerated; no safety issues were observed.
CONCLUSIONS


Plasma and urine pharmacokinetics for Asacol TID, Asacol QD and Lialda QD are similar, suggesting similar daily systemic exposures can be obtained with either TID or QD dosing. NCT00751699.",2020,Mean urinary excretion of 5-ASA plus N-Ac-5-ASA was comparable between treatments [Dose A: 21.3%; Dose B: 20.2%; Dose C: 17.9%].,"['All enrolled volunteers [N = 37] completed the study', 'Healthy Adult Volunteers', 'healthy adult volunteers']","['Asacol 6× 400 mg QD', 'Asacol 2× 400 mg three-times-daily [TID', 'mesalamine pharmacokinetics following Lialda 2× 1.2 g once-daily [QD', 'oral delayed-release mesalamine formulations', 'Mesalamine', 'Two Oral Delayed-Release Mesalamine Formulations']","['safety and tolerability', 'Mean urinary excretion of 5-ASA plus N-Ac-5-ASA', 'Steady-state', '5-aminosalicylic acid [5-ASA] and N-acetyl 5-aminosalicylic acid [N-Ac-5-ASA; primary metabolite] pharmacokinetics ', 'tolerated; no safety issues']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0678172', 'cui_str': 'Asacol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1873792', 'cui_str': 'Lialda'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0067638', 'cui_str': 'N-acetyl-5-aminosalicylic acid'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",,0.146909,Mean urinary excretion of 5-ASA plus N-Ac-5-ASA was comparable between treatments [Dose A: 21.3%; Dose B: 20.2%; Dose C: 17.9%].,"[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Vande Casteele', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Jersey City, NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McNamee', 'Affiliation': 'Allergan Biologics Ltd, Liverpool, UK.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14479']
2838,32671864,Editorial Comment to Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study 2): A randomized prospective evaluation.,,2020,,['after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study\xa02'],['Transient stent placement versus tubeless procedure'],[],"[{'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0348151,,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14309']
2839,32672329,Aiding shared decision making in lung cancer screening: two decision tools.,"BACKGROUND


Shared decision making (SDM) preceding lung cancer screening is important for populations that are underrepresented in lung cancer screening trials. Current evidence-based guidelines; however, do not address personal risk and outcomes in underrepresented populations. This study compared two SDM decision aids (Option Grids and Shouldiscreen.com) for SDM efficacy, decision regret and knowledge.
METHODS


We conducted a prospective trial of lung cancer screening patients (N = 237) randomized to SDM with Option Grids or Shouldiscreen.com. To evaluate the SDM process after lung cancer screening, patients answered two questionnaires: CollaboRATE and Decision Regret. Patients also completed a questionnaire to test their knowledge of lung cancer screening.
RESULTS


Patients were predominantly African American (61.6%), though multiple races, varying education levels and equal genders were represented. Patients in both Option Grids and Shouldiscreen.com groups reported favorable SDM experiences (P = 0.60) and equivalent knowledge about lung cancer screening (P = 0.43). Patients using Shouldiscreen.com had less knowledge regarding the potential complications of subsequent testing (P = 0.02). Shouldiscreen.com patients had increased regret regarding their decision to pursue screening (P = 0.02).
CONCLUSIONS


Option Grids and Shouldiscreen.com both facilitated a meaningful SDM process. However, Option Grids patients experienced decreased decision regret and enhanced knowledge of the potential complications of screening.",2020,Patients using Shouldiscreen.com had less knowledge regarding the potential complications of subsequent testing (P = 0.02).,"['lung cancer screening patients (N\xa0=\xa0237', 'lung cancer screening']","['SDM with Option Grids or Shouldiscreen.com', 'SDM decision aids (Option Grids and Shouldiscreen.com']","['SDM efficacy, decision regret and knowledge', 'equivalent knowledge about lung cancer screening', 'regret regarding their decision to pursue screening', 'decision regret', 'favorable SDM experiences']","[{'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",237.0,0.0257629,Patients using Shouldiscreen.com had less knowledge regarding the potential complications of subsequent testing (P = 0.02).,"[{'ForeName': 'Shelby R', 'Initials': 'SR', 'LastName': 'Sferra', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia 19140, PA, USA.'}, {'ForeName': 'Joyce S', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Medical Students, Lewis Katz School of Medicine, Temple University, Philadelphia 19140, PA, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Boynton', 'Affiliation': 'Medical Students, Lewis Katz School of Medicine, Temple University, Philadelphia 19140, PA, USA.'}, {'ForeName': 'Verdi', 'Initials': 'V', 'LastName': 'DiSesa', 'Affiliation': 'Temple University Health System, Philadelphia 19140, PA, USA.'}, {'ForeName': 'Larry R', 'Initials': 'LR', 'LastName': 'Kaiser', 'Affiliation': 'Department of Thoracic Medicine and Surgery; Temple University Health System, Philadelphia 19140, PA, USA.'}, {'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine Temple University, Philadelphia 19140, PA, USA.'}, {'ForeName': 'Cherie P', 'Initials': 'CP', 'LastName': 'Erkmen', 'Affiliation': 'Department of Thoracic Medicine and Surgery; Temple University Health System, Philadelphia 19140, PA, USA.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdaa063']
2840,32672489,No advantage of Imatinib in combination with hydroxyurea over Imatinib monotherapy: a study of the East German Study Group (OSHO) and the German CML study group.,"INTRODUCTION


The combination of Imatinib (IM) and hydroxyurea (HU) was explored for the treatment of chronic myelogenous leukemia (CML).
METHOD


After  in vitro  testing and a phase I study ( n  = 20), 59 patients were randomized in the IM/HU and 29 in the IM arm. According to protocol, 49 propensity-score matched IM patients were included from the CML-IV study.
RESULTS


Additive specific inhibition of CML cells by IM/HU was detected  in vitro . HU 500 mg qd in combination with IM 400 mg qd proved feasible in the phase I study. Overall, no significant difference with respect to major molecular response (MMR) at 18 months (IM/HU and IM 66%; primary endpoint) was observed. Significant differences were noted for MMR at 6 months ( p  = 0.04) and for cumulative incidences of adverse events ( p  = 0.03) in favor of IM monotherapy (secondary endpoints).
CONCLUSION


IM/HU combination was more potent in selectively inhibiting CML cells  in vitro , but not superior to IM  in vivo . (NCT02480608).",2020,"Significant differences were noted for MMR at 6 months ( p  = 0.04) and for cumulative incidences of adverse events ( p  = 0.03) in favor of IM monotherapy (secondary endpoints).
","['After  in\xa0vitro  testing and a phase I study ( n \u2009=\u200920), 59 patients', '49 propensity-score matched IM patients were included from the CML-IV study', 'chronic myelogenous leukemia (CML']","['Imatinib (IM) and hydroxyurea (HU', 'HU 500', 'hydroxyurea over Imatinib monotherapy']","['cumulative incidences of adverse events', 'major molecular response (MMR', 'MMR']","[{'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",59.0,0.024594,"Significant differences were noted for MMR at 6 months ( p  = 0.04) and for cumulative incidences of adverse events ( p  = 0.03) in favor of IM monotherapy (secondary endpoints).
","[{'ForeName': 'Thoralf', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Abteilung Hämatologie und Onkologie, Universität Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Niederwieser', 'Affiliation': 'Klinik für Stammzelltransplantation, Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Gil', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Krahl', 'Affiliation': 'Abteilung Hämatologie und Onkologie, Universität Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'von Grünhagen', 'Affiliation': 'Gemeinschaftspraxis Hämatologie und Onkologie, Cottbus, Germany.'}, {'ForeName': 'Haifa Kathrin', 'Initials': 'HK', 'LastName': 'Al-Ali', 'Affiliation': 'Abteilung Hämatologie und Onkologie, Universität Leipzig, Leipzig, Germany.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Jentsch-Ullrich', 'Affiliation': 'Gemeinschaftspraxis für Hämatologie und Onkologie, Magdeburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spohn', 'Affiliation': 'Gemeinschaftspraxis für Hämatologie und Onkologie, Halle, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Lakner', 'Affiliation': 'Gemeinschaftspraxis für Hämatologie und Onkologie, Rostock, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Assmann', 'Affiliation': 'MVZ Elblandpolikliniken GmbH, Riesa, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Junghanss', 'Affiliation': 'Medizinische Klinik III, Universität Rostock, Rostock, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cross', 'Affiliation': 'Abteilung Hämatologie und Onkologie, Universität Leipzig, Leipzig, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'III. Medizinische Klinik, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Deininger', 'Affiliation': 'Division of Hematology and Hematologic Malignancies, Huntsman Cancer Institute, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'School of Medicine, University Leipzig, Leipzig Germany.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1786556']
2841,32672505,Correlates of reproductive coercion among college women in abusive relationships: baseline data from the college safety study.,"OBJECTIVE


The purpose of this study was to examine correlates of reproductive coercion (RC) among a sample of college women in abusive relationships.  Participants:  354 college students reporting a recent history of intimate partner violence (IPV).  Methods:  This study examines baseline data from a randomized controlled trial testing effectiveness of an interactive safety decision aid (myPlan).  Results:  Almost a quarter (24.3%) of the sample reported RC. Associated factors included races other than White ( p  = 0.019), relationship instability ( p  = 0.022), missing class due to relationship problems ( p  = 0.001), IPV severity ( p  < 0.001), technology abuse ( p  < 0.001), traumatic brain injury-associated events ( p  < 0.001), and depression ( p  = 0.024).  Conclusions:  RC was a significant predictor of depression, with implications for providers working with abused college women regarding the need for mental health services concurrent with IPV/RC services. A larger proportion of women who experienced RC sought help from a healthcare provider for contraception, which suggests intervention opportunities for college health providers.",2020,"A larger proportion of women who experienced RC sought help from a healthcare provider for contraception, which suggests intervention opportunities for college health providers.","['Participants:  354 college students reporting a recent history of intimate partner violence (IPV', 'college women in abusive relationships']",['interactive safety decision aid (myPlan'],"['reproductive coercion (RC', 'relationship instability', 'technology abuse', 'traumatic brain injury-associated events', 'IPV severity']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",354.0,0.318851,"A larger proportion of women who experienced RC sought help from a healthcare provider for contraception, which suggests intervention opportunities for college health providers.","[{'ForeName': 'Karen Trister', 'Initials': 'KT', 'LastName': 'Grace', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Perrin', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Clough', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""School of Medicine, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Glass', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1790570']
2842,32672515,"Effects of the MINDSTRONG© CBT-based program on depression, anxiety and healthy lifestyle behaviors in graduate health sciences students.","OBJECTIVE


To evaluate effects of the MINDSTRONG ©  cognitive-behavioral skills building program versus an attention control program on mental health outcomes and lifestyle behaviors of graduate health professional students.  Participants:  201 entering graduate students from seven health sciences colleges at a public land grant University in the U.S. Midwest.  Methods:  A randomized controlled trial was conducted with three-month follow-up. Valid and reliable instruments measured depression, anxiety, stress, healthy lifestyle beliefs and healthy lifestyle behaviors.  Results:  Students receiving MINDSTRONG ©  reported less depression/anxiety and healthier lifestyle behaviors than those receiving the control program. Students with elevated levels of depression/anxiety at baseline demonstrated greater benefits from the program.  Conclusions:  MINDSTRONG ©  can be used as a preventive and early intervention for improving mental health outcomes and lifestyle behaviors in graduate students. Because the program can be delivered by trained non-mental health professionals, it has the potential to be widely scaled on campuses throughout the U.S.",2020,Students receiving MINDSTRONG ©  reported less depression/anxiety and healthier lifestyle behaviors than those receiving the control program.,"['Participants:  201 entering graduate students from seven health sciences colleges at a public land grant University in the U.S. Midwest', 'graduate health sciences students', 'graduate students', 'graduate health professional students']","['CBT-based program', 'attention control program']","['mental health outcomes and lifestyle behaviors', 'depression, anxiety and healthy lifestyle behaviors', 'depression/anxiety and healthier lifestyle behaviors', 'depression/anxiety', 'depression, anxiety, stress, healthy lifestyle beliefs and healthy lifestyle behaviors']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",201.0,0.0346067,Students receiving MINDSTRONG ©  reported less depression/anxiety and healthier lifestyle behaviors than those receiving the control program.,"[{'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Mazurek Melnyk', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoying', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ''}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1782922']
2843,32672635,"Treatment Outcomes of Mitomycin C-Augmented Trabeculectomy, Sub-Tenon Injection versus Soaked Sponges, after 3 Years of Follow-up: A Randomized Clinical Trial.","PURPOSE


To report the 3-year outcome of trabeculectomy with mitomycin C (MMC)-soaked sponges versus intra-Tenon injection of MMC in eyes with uncontrolled primary open-angle glaucoma.
DESIGN


Randomized clinical trial.
PARTICIPANTS


Eighty-two consecutive patients with uncontrolled primary open-angle glaucoma.
METHODS


Participants were randomized either to intra-Tenon injection of 0.1 ml of 0.01% MMC (TI group) or 0.02% subconjunctival application of MMC-soaked sponges (TS group). Patients were followed up for 3 years after surgery. The data for 73 eyes were included in the final analysis.
MAIN OUTCOME MEASURES


The primary outcome measure was the surgical success, defined as intraocular pressure (IOP) more than 5 mmHg and <21 mmHg, and IOP reduction of 20% or more from baseline, no reoperation for glaucoma, and no loss of light perception vision. Secondary outcome measures were IOP, glaucoma medications, best-corrected visual acuity (VA), bleb morphologic features according to the Indiana Bleb Appearance Grading Scale, complications, and endothelial cell count changes.
RESULTS


The cumulative probability of success at 3-year follow-up was 72.2% in the TI group and 65.1% in the TS group (P = 0.30). Uncontrolled IOP was the most common reason for failure. The mean preoperative IOP was 22.4±4.6 mmHg with an average of 3.1±1.0 medications. At 3 years, final IOP was 15.3±3.7 mmHg in the TI group and 16.4±3.5 mmHg in the TS group (P = 0.55). Mean glaucoma number of medications was 0.9±1.1 and 1.1±1.1 in the TI and TS groups, respectively (P = 0.54). Blebs tended to be more diffuse (P = 0.032), less vascularized (P = 0.013), and more shallow (P = 0.012) after intra-Tenon injection. Visual outcomes and endothelial cell changes were similar in both groups (P = 0.47 and P = 0.94, respectively).
CONCLUSIONS


Although the success rate and IOP reduction were comparable with both techniques, bleb morphologic parameters were more favorable after intra-Tenon injection of 0.1 ml of 0.01% MMC.",2018,"Visual outcomes and endothelial cell changes were similar in both groups (P = 0.47 and P = 0.94, respectively).
","['Participants', 'eyes with uncontrolled primary open-angle glaucoma', 'Eighty-two consecutive patients with uncontrolled primary open-angle glaucoma', '73 eyes were included in the final analysis']","['intra-Tenon injection of 0.1 ml of 0.01% MMC (TI group) or 0.02% subconjunctival application of MMC-soaked sponges (TS group', 'Mitomycin C-Augmented Trabeculectomy, Sub-Tenon Injection versus Soaked Sponges', 'trabeculectomy with mitomycin C (MMC)-soaked sponges versus intra-Tenon injection of MMC']","['final IOP', 'surgical success, defined as intraocular pressure (IOP', 'success rate and IOP reduction', 'Mean glaucoma number of medications', 'cumulative probability of success', 'Visual outcomes and endothelial cell changes', 'bleb morphologic parameters', 'mean preoperative IOP', 'IOP, glaucoma medications, best-corrected visual acuity (VA), bleb morphologic features according to the Indiana Bleb Appearance Grading Scale, complications, and endothelial cell count changes', 'reoperation for glaucoma, and no loss of light perception vision', 'IOP reduction']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",82.0,0.17897,"Visual outcomes and endothelial cell changes were similar in both groups (P = 0.47 and P = 0.94, respectively).
","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Esfandiari', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Ophthalmology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pakravan', 'Affiliation': 'Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': 'Ocular Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Doozandeh', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Conner', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. Electronic address: connerip@upmc.edu.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2018.06.003']
2844,32672643,Lifetime Risk of Visual Impairment Resulting from Glaucoma in Patients Initially Followed up for Elevated Intraocular Pressure.,"PURPOSE


To report the lifetime risk of visual impairment resulting from glaucoma in patients originally followed up in a 10-year prospective randomized study initiated in 1981 to assess patients with elevated intraocular pressure (IOP).
DESIGN


Retrospective patient chart review.
PARTICIPANTS


Data on deceased patients who initially were followed up prospectively in the randomized controlled study and thereafter were followed up in ordinary clinical practice were collected until the end of 2017. Inclusion in the original study required an untreated IOP of 22 mmHg or more and 1 or more risk factors for glaucoma.
METHODS


Visual impairment, low vision, and blindness were defined according to the World Health Organization criteria. All eyes that became visually impaired were registered, including the date and cause of the impairment; the cumulative incidence of visual impairment corrected for competing risks was calculated; and the Kaplan-Meier method was used to analyze the importance of risk factors present at baseline for 1 eye per patient.
MAIN OUTCOME MEASURES


The proportion of patients who became bilaterally visually impaired because of glaucoma, the cumulative incidence of glaucoma-related visual impairment in at least 1 eye, and potential baseline risk factors for visual impairment caused by glaucoma.
RESULTS


Seventy-seven of 90 patients (86%) included in the initial randomized study were deceased at the end of 2017. Four patients were lost to follow-up during the clinical follow-up. Of the 77 patients, 7 (9%) became bilaterally visually impaired and 2 of those 7 became bilaterally blind because of glaucoma. The cumulative incidence of glaucoma-induced visual impairment in at least 1 eye increased from 0.00 after 5 years to 0.22 (95% confidence interval [CI], -0.01 to 0.67) after 30 years. The cumulative incidence of glaucoma blindness in at least 1 eye increased from 0.00 after 5 years to 0.17 (95% CI, 0.10-0.54) after 30 years. No specific risk factor significantly increased the risk of visual impairment caused by glaucoma.
CONCLUSIONS


Although the investigated patients showed elevated IOP and at least 1 additional glaucoma risk factor (i.e., they were high-risk patients), only a relatively small proportion of the patients with glaucoma demonstrated visual impairment.",2020,"The cumulative incidence of glaucoma blindness in at least 1 eye increased from 0.00 after 5 years to 0.17 (95% CI, 0.10-0.54) after 30 years.","['Visual impairment, low vision, and blindness were defined according to the World Health Organization criteria', 'Data on deceased patients who initially were followed up prospectively in the randomized controlled study and thereafter were followed up in ordinary clinical practice were collected until the end of 2017', 'visual impairment resulting from glaucoma in patients originally followed up in a 10-year prospective randomized study initiated in 1981 to assess patients with elevated intraocular pressure (IOP', 'Seventy-seven of 90 patients (86%) included in the initial randomized study were deceased at the end of 2017']",[],"['cumulative incidence of glaucoma blindness', 'visual impairment', 'Lifetime Risk of Visual Impairment', 'elevated IOP', 'cumulative incidence of glaucoma-induced visual impairment', 'risk of visual impairment']","[{'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",4.0,0.240291,"The cumulative incidence of glaucoma blindness in at least 1 eye increased from 0.00 after 5 years to 0.17 (95% CI, 0.10-0.54) after 30 years.","[{'ForeName': 'Sigridur E', 'Initials': 'SE', 'LastName': 'Oskarsdottir', 'Affiliation': 'Department of Clinical Sciences Malmö, Department of Ophthalmology, Lund University, Malmö, Sweden. Electronic address: sigridur.oskarsdottir@med.lu.se.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Heijl', 'Affiliation': 'Department of Clinical Sciences Malmö, Department of Ophthalmology, Lund University, Malmö, Sweden.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Midlöv', 'Affiliation': 'Department of Clinical Sciences Malmö, Center for Primary Health Care Research, Lund University, Malmö, Sweden.'}, {'ForeName': 'Boel', 'Initials': 'B', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Clinical Sciences Malmö, Department of Ophthalmology, Lund University, Malmö, Sweden.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.09.002']
2845,32672653,Predictors of Short-Term Intraocular Pressure Change after Laser Peripheral Iridotomy: A Prospective Randomized Study.,"PURPOSE


To describe short-term intraocular pressure (IOP) changes after laser peripheral iridotomy (LPI) and identify factors predicting IOP lowering.
DESIGN


Multicenter, prospective randomized study.
PARTICIPANTS


Four hundred fifty-five South Indian eyes of 455 participants 30 years of age or older with a diagnosis of primary angle-closure suspect (PACS), primary angle closure (PAC), or PAC glaucoma (PACG).
METHODS


Participants were randomized to superior or nasal/temporal LPI. Multivariate regression models were used to determine preoperative features and LPI parameters associated with change in IOP from baseline to the 2-week postoperative examination.
MAIN OUTCOME MEASURES


Change in IOP at 2 weeks after LPI compared with baseline.
RESULTS


Among all treated eyes, 11.0% of eyes demonstrated a 20% or more decrease in IOP after LPI, whereas 19.6% demonstrated at least a 20% increase in IOP. Intraocular pressure changes occurring after LPI did not differ by LPI location (P > 0.5 for all comparisons). Although the anterior chamber angle widened after LPI (P < 0.001) and was classified as open after laser in most eyes (64% in all 4 quadrants), there was no significant association between gonioscopic angle opening and LPI-induced IOP change (P = 0.7). Linear regression analysis demonstrated more IOP lowering with higher baseline IOP (3.2 mmHg more lowering per 10-mmHg higher baseline IOP; 95% confidence interval [CI], 2.3-4.1 mmHg) and PAC/PACG diagnosis (1.4 mmHg more IOP lowering vs. PACS diagnosis; 95% CI, 0.2-2.6 mmHg) predicted a lower IOP after LPI. After multivariate adjustment, only higher baseline IOP predicted lower IOP after LPI (P < 0.001). Features not associated with IOP lowering included demographic, visual, and A-scan measures; baseline gonioscopic angle width; total laser energy; LPI area; and LPI location (P > 0.08 for all). Eyes with PAC/PACG, as compared with PACS, demonstrated more IOP lowering after LPI (1.2±1.7 mmHg vs. -0.4±1.0 mmHg; P < 0.001) after adjusting for baseline IOP.
CONCLUSIONS


Neither LPI location nor degree of gonioscopic angle opening was associated with statistically significant change in IOP after LPI. Although significant IOP lowering after LPI was uncommon in the overall cohort, higher baseline IOP and PAC/PACG diagnosis predicted lower postoperative IOP.",2018,Intraocular pressure changes occurring after LPI did not differ by LPI location (P > 0.5 for all comparisons).,"['Four hundred fifty-five South Indian eyes of 455 participants 30 years of age or older with a diagnosis of primary angle-closure suspect (PACS), primary angle closure (PAC), or PAC glaucoma (PACG', 'Participants']","['Short-Term Intraocular Pressure Change after Laser Peripheral Iridotomy', 'superior or nasal/temporal LPI', 'laser peripheral iridotomy (LPI']","['PAC/PACG diagnosis', 'IOP lowering', 'IOP lowering after LPI', 'demographic, visual, and A-scan measures; baseline gonioscopic angle width; total laser energy; LPI area; and LPI location', 'postoperative IOP', 'Intraocular pressure changes', 'IOP', 'IOP after LPI', 'gonioscopic angle opening and LPI-induced IOP change']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",455.0,0.255217,Intraocular pressure changes occurring after LPI did not differ by LPI location (P > 0.5 for all comparisons).,"[{'ForeName': 'Nazlee', 'Initials': 'N', 'LastName': 'Zebardast', 'Affiliation': 'Glaucoma Division, Wilmer Eye Institute, John Hopkins University, Baltimore, Maryland; Glaucoma Division, Dana Center for Preventive Ophthalmology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Kavitha', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Palaniswamy', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Mohideen Abdul', 'Initials': 'MA', 'LastName': 'Kader', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Tirunelveli, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raman', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Coimbatore, India.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Rajendrababu', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Glaucoma Division, Wilmer Eye Institute, John Hopkins University, Baltimore, Maryland; Glaucoma Division, Dana Center for Preventive Ophthalmology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Rengaraj', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India. Electronic address: venkatesh@pondy.aravind.org.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2018.10.005']
2846,32672654,Ahmed Glaucoma Valve Implantation: Graft-Free Short Tunnel Small Flap versus Scleral Patch Graft after 1-Year Follow-up: A Randomized Clinical Trial.,"PURPOSE


To compare the efficacy and safety of the graft-free short tunnel small flap (STSF) technique with that of the scleral patch graft (SPG) in Ahmed glaucoma valve (AGV) (New World Medical Inc, Rancho Cucamonga, CA) implantation.
DESIGN


Randomized clinical trial.
PARTICIPANTS


A total of 203 eyes of 203 patients with medically uncontrolled glaucoma, including 102 in the STSF group and 101 in the SPG group.
METHODS


Patients were enrolled and assigned randomly to STSF or SPG.
MAIN OUTCOME MEASURES


Tube exposure, intraocular pressure (IOP), number of glaucoma medications, best-corrected visual acuity, surgical complications, and success rate (defined as IOP >5 mmHg, ≤21 mmHg, and IOP reduction ≥20% from baseline at 2 consecutive visits after 3 months, no reoperation for glaucoma).
RESULTS


Only 1 patient in the SPG group developed tube exposure at 1-year follow-up. The cumulative probability of success during the first year of follow-up was 70% in the STSF group and 65% in the SPG group (P = 0.36). The IOP decreased significantly from 29.6±8.6 mmHg at baseline to 16.4±3.6 mmHg at the final follow-up in the STSF group (P = 0.001). The corresponding numbers for the SPG group were 30.9±11.2 and 15.8±4.7, respectively (P = 0.001). The final IOP was comparable between both groups (P = 0.65). Mean ± standard deviation of the number of glaucoma medications was 1.8±0.9 in the STSF group and 1.6±0.9 in the SPG group at final follow-up (P = 0.32). Postoperative complications developed in 8 patients (19%) in the STSF group and 9 patients (23%) in the SPG group (P = 0.81).
CONCLUSIONS


The STSF and SPG techniques had a comparable complication rate at the 1-year follow-up. Both techniques were comparable in terms of success rate, postoperative IOP, and glaucoma medications.",2018,The STSF and SPG techniques had a comparable complication rate at the 1-year follow-up.,"['Patients were enrolled and assigned randomly to', 'Ahmed glaucoma valve (AGV', 'A total of 203 eyes of 203 patients with medically uncontrolled glaucoma, including 102 in the STSF group and 101 in the SPG group']","['scleral patch graft (SPG', 'STSF', 'STSF or SPG', 'graft-free short tunnel small flap (STSF) technique', 'Glaucoma Valve Implantation: Graft-Free Short Tunnel Small Flap versus Scleral Patch Graft']","['final IOP', 'success rate, postoperative IOP, and glaucoma medications', 'Mean\xa0±\xa0standard deviation of the number of glaucoma medications', 'Tube exposure, intraocular pressure (IOP), number of glaucoma medications, best-corrected visual acuity, surgical complications, and success rate (defined as IOP ', 'cumulative probability of success', 'efficacy and safety', 'IOP', 'tube exposure', 'Postoperative complications', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",203.0,0.0935188,The STSF and SPG techniques had a comparable complication rate at the 1-year follow-up.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pakravan', 'Affiliation': 'Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadmehdi', 'Initials': 'M', 'LastName': 'Hatami', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Esfandiari', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. Electronic address: hmdesfandiary@gmail.com.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': 'Ocular Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Doozandeh', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Samaeili', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Conner', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2018.10.008']
2847,32672806,Effectiveness of a Multimedia Educational Intervention to Improve Understanding of the Risks and Benefits of Palliative Chemotherapy in Patients With Advanced Cancer: A Randomized Clinical Trial.,"Importance


Despite requirements of informed consent, patients with advanced cancer often receive palliative chemotherapy (PC) without understanding that the likelihood of cure is remote.
Objective


To determine whether a PC educational video and booklet at treatment initiation could improve patients' understanding of its benefits and risks.
Interventions


Regimen-specific PC videos and booklets presenting information about logistics, potential benefits, life expectancy (optional), adverse effects, and alternatives. Videos featured authentic patients sharing diverse experiences. After receiving treatment recommendations, research assistants distributed materials to patients for independent review.
Design, Setting, and Participants


Multicenter randomized clinical trial of patients with advanced colorectal or pancreatic cancer starting first-line or second-line PC in 5 US cancer centers with enrollment from June 2015 to September 2017 and follow-up to December 2019.
Main Outcomes and Measures


The primary outcome was accurate expectations of chemotherapy benefits at 3 months, defined as responding ""not at all likely"" to ""What is your understanding of how likely the chemotherapy is to cure your cancer?"" (from the Cancer Care Outcomes Research and Surveillance study). Secondary outcomes included understanding of adverse effects, decisional conflict (SURE test), regret (Decisional Regret Scale), and distress (Functional Assessment of Cancer Therapy-General emotional well-being subscale).
Results


Among 186 patients with advanced colorectal or pancreatic cancer who were starting first-line or second-line PC (94 randomized to usual care, 92 to intervention; mean [SD] age, 59.3 [12.6] [range, 28-86] years; 107 [58%] male; 118 [63.4%] colorectal and 68 [36.6%] pancreatic cancer), most patients wanted ""a lot"" of information or ""as much information as possible"" about adverse effects (149, 80.1%), likelihood of cure (148, 79.6%), and prognosis (148, 79.6%). Among the intervention arm, 59 (78%) reviewed the booklet and 30 (40%) reviewed the video within 2 weeks. The primary outcome did not differ between intervention and control arms (52.6%; 95% CI, 40.3%-65.0%; vs 55.5%; 95% CI, 45.1%-66.0%). Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance. The intervention did not increase distress, despite frank prognostic information. Other secondary outcomes were similar.
Conclusions and Relevance


Provision of an educational video and booklet did not alter patients' expectation of cure from PC. Alternative delivery strategies, such as integration with nurse teaching, could be explored in future studies.
Trial Registration


ClinicalTrials.gov Identifier: NCT02282722.",2020,"Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance.","['Patients With Advanced Cancer', 'patients with advanced cancer often receive', 'patients with advanced colorectal or pancreatic cancer starting first-line or second-line PC in 5 US cancer centers with enrollment from June 2015 to September 2017 and follow-up to December 2019', '186 patients with advanced colorectal or pancreatic cancer who were starting first-line or second-line PC (94 randomized to usual care, 92 to intervention; mean [SD] age, 59.3 [12.6] [range, 28-86] years; 107 [58%] male; 118 [63.4%] colorectal and 68']","['Palliative Chemotherapy', 'palliative chemotherapy (PC', 'PC educational video and booklet', 'Multimedia Educational Intervention']","['likelihood of cure', 'understanding of adverse effects, decisional conflict (SURE test), regret (Decisional Regret Scale), and distress (Functional Assessment of Cancer Therapy-General emotional well-being subscale', 'accurate expectations of chemotherapy benefits', 'distress, despite frank prognostic information', 'pancreatic cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]",186.0,0.171388,"Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Enzinger', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Dana-Farber/Partners CancerCare, Boston, Massachusetts.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sanoff', 'Affiliation': 'Division of Medical Oncology, University of North Carolina Lineberger Cancer Center, Chapel Hill.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Van Loon', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Matin', 'Affiliation': 'Division of Medical Oncology, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cronin', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Cibotti', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bagley', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schrag', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1921']
2848,32672829,Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial.,"Importance


Diabetic foot ulcers are a common complication of diabetes and require specialized treatment. Cold atmospheric plasma (CAP) has been associated with benefits in wound infection and healing in previous smaller series of case reports. Yet the effect of CAP compared with standard care therapy in wound healing in diabetic foot ulcers remains to be studied.
Objective


To determine whether the application of CAP accelerates wound healing in diabetic foot ulcers compared with standard care therapy.
Design, Setting, and Participants


A prospective, randomized, placebo-controlled, patient-blinded clinical trial was conducted at 2 clinics with recruitment from August 17, 2016, to April 20, 2019. Patients were scheduled to remain in follow-up until April 30, 2024. Patients with diabetes and diabetic foot ulcers described using the combined Wagner-Armstrong classification of 1B or 2B (superficial or infected diabetic foot ulcers extending to tendon) were eligible. A patient could participate with 1 or more wounds in both groups in both intervention and control groups. Wounds were randomized separately, allowing a participant to be treated several times within the study following a 2 × 2 × 2 randomization strata considering sex, smoking status, and age (≤68 years and >68 years).
Interventions


Standard care treatment with 8 applications of either CAP generated from argon gas in an atmospheric pressure plasma jet or 8 applications of placebo treatment in a patient-blinded manner.
Main Outcomes and Measures


Primary end points were reduction in wound size, clinical infection, and microbial load compared with treatment start. Secondary end points were time to relevant wound reduction (>10%), reduction of infection, parameters of patient's well-being, and treatment-associated adverse events.
Results


Of 65 diabetic foot ulcer wounds from 45 patients assessed for study, 33 wounds from 29 patients were randomized to CAP and 32 wounds from 28 to placebo, with 62 wounds from 43 patients (31 wounds per group) included for final evaluation (mean [SD] age, 68.5 [9.1] years for full sample). Four patients with 5 wounds of 31 (16.1%) wounds in the CAP group and 3 patients with 4 wounds of 31 (13%) wounds in the placebo group were active smokers. CAP therapy yielded a significant increase in wound healing, both in total mean (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009). Reduction of infection and microbial load was not significantly different between CAP and placebo. No therapy-related adverse events occurred during therapy; patient's perceptions during therapy were comparable.
Conclusions and Relevance


In this randomized clinical trial, CAP therapy resulted in beneficial effects in chronic wound treatment in terms of wound surface reduction and time to wound closure independent from background infection.
Trial Registration


ClinicalTrials.gov Identifier: NCT04205942.",2020,"CAP therapy yielded a significant increase in wound healing, both in total mean (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009).","['Patients were scheduled to remain in follow-up until April 30, 2024', ' with 62 wounds from 43 patients (31 wounds per group) included for final evaluation (mean [SD] age, 68.5 [9.1] years for full sample', 'Patients With Diabetic Foot Ulcers', '2 clinics with recruitment from August 17, 2016, to April 20, 2019', 'diabetic foot ulcers', '65 diabetic foot ulcer wounds from 45 patients assessed for study, 33 wounds from 29 patients', 'Patients with diabetes and diabetic foot ulcers described using the combined Wagner-Armstrong classification of 1B or 2B (superficial or infected diabetic foot ulcers extending to tendon) were eligible']","['CAP therapy', 'Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo', 'Cold atmospheric plasma (CAP', 'standard care therapy', 'CAP', 'placebo']","[""reduction of infection, parameters of patient's well-being, and treatment-associated adverse events"", 'time to relevant wound reduction', 'Wound Healing', 'total mean (SD) area reduction', 'wound healing', 'adverse events', 'reduction in wound size, clinical infection, and microbial load', 'Reduction of infection and microbial load']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",4.0,0.164355,"CAP therapy yielded a significant increase in wound healing, both in total mean (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009).","[{'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Stratmann', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Tania-Cristina', 'Initials': 'TC', 'LastName': 'Costea', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Nolte', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hiller', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Reindel', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Masur', 'Affiliation': 'Leibniz-Institut für Plasmaforschung und Technologie, Greifswald, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Motz', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Timm', 'Affiliation': 'Competence Center for Clinical Studies Bremen, Bremen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kerner', 'Affiliation': 'Klinikum Karlsburg der Klinikgruppe Dr Guth GmbH & Co KG, Karlsburg, Germany.'}, {'ForeName': 'Diethelm', 'Initials': 'D', 'LastName': 'Tschoepe', 'Affiliation': 'Diabeteszentrum, Herz- und Diabeteszentrum Nordrhein Westfalen (NRW), Ruhr Universität Bochum, Bad Oeynhausen, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.10411']
2849,32672864,"Nuevo Amanecer-II: results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors.","OBJECTIVE


We report results of a community-based multisite, randomized controlled trial of Nuevo Amanecer (NA-II), a 10-week stress management program for rural, low literacy Latina breast cancer survivors.
METHODS


Trained peers delivered NA-II to Spanish-speaking Latinas with non-metastatic breast cancer in three rural communities. Women were randomized to receive the program immediately or wait 6 months. Assessments were conducted at baseline, 3 months, and 6 months. Primary outcomes were breast cancer-specific quality of life domains; secondary outcomes included general distress symptoms and stress management skills. Intention-to-treat analyses using repeated-measures linear regression models estimated changes in slope between groups.
RESULTS


Of 153 participants (76 randomized to intervention, 77 to control group), 92% were retained at 6 months. Mean age was 54.8 years (SD = 10.5); 80% had less than high school education. There were no statistically significant treatment x time effects on quality of life. Compared to women in the control group, intervention group women reported greater improvements in anxiety at 6 months (-0.20 vs -0.02, P = .049; range 0-4) as well as three stress management skills: relaxation at 3 months (+0.98 vs -0.07, P < .0001; range 0-4) and 6 months (+0.82 vs +0.04, P < .001), awareness of tension at 3 months (+0.31 vs -0.19, P < .01; range 0-4) and 6 months (+0.29 vs -0.11, P < .05), and coping confidence at 3 months (+0.12 vs -0.23, P < .01; range 0-4).
CONCLUSIONS


Stress management programs delivered by trained peers in rural community settings can reduce anxiety and improve stress management skills among Latina breast cancer survivors. This article is protected by copyright. All rights reserved.",2020,"CONCLUSIONS


Stress management programs delivered by trained peers in rural community settings can reduce anxiety and improve stress management skills among Latina breast cancer survivors.","['Trained peers delivered NA-II to Spanish-speaking Latinas with non-metastatic breast cancer in three rural communities', 'rural, low literacy Latina breast cancer survivors', 'Latina breast cancer survivors', 'rural Latina breast cancer survivors', 'Mean age was 54.8\u2009years (SD\xa0=\xa010.5); 80% had less than high school education', '153 participants ']","['Nuevo Amanecer (NA-II', 'community-based participatory, peer-delivered stress management intervention']","['quality of life', 'breast cancer-specific quality of life domains; secondary outcomes included general distress symptoms and stress management skills', 'stress management skills: relaxation', 'stress management skills', 'anxiety', 'awareness of tension', 'coping confidence']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",153.0,0.0910708,"CONCLUSIONS


Stress management programs delivered by trained peers in rural community settings can reduce anxiety and improve stress management skills among Latina breast cancer survivors.","[{'ForeName': 'Anna María', 'Initials': 'AM', 'LastName': 'Nápoles', 'Affiliation': 'National Institute on Minority Health and Health Disparities, National Institutes of Health, 9000 Rockville Pike, Building 3, Floor 5, Room E08, Bethesda, Maryland.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Santoyo-Olsson', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Stewart', 'Affiliation': 'Center for Aging in Diverse Communities, UCSF, 3333 California St., Suite 335, San Francisco, California, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ortiz', 'Affiliation': 'Círculo de Vida Cancer Support and Resource Center, 2601 Mission Street, Suite 702, San Francisco, California, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Samayoa', 'Affiliation': 'Health Equity Research Lab, Department of Biology, San Francisco State University, San Francisco, California, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Torres-Nguyen', 'Affiliation': 'Kaweah Delta Health Care District, 400 W. Mineral King, Visalia, California, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Palomino', 'Affiliation': 'Cancer Resource Center of the Desert, 444 So. 8th St, Suite B-3, El Centro, California, USA.'}, {'ForeName': 'LaVerne', 'Initials': 'L', 'LastName': 'Coleman', 'Affiliation': 'WomenCARE/Entre Nosotras, Family Service Agency of the Central Coast, 2901 Park, California, USA.'}, {'ForeName': 'Aday', 'Initials': 'A', 'LastName': 'Urias', 'Affiliation': 'Cancer Resource Center of the Desert, 444 So. 8th St, Suite B-3, El Centro, California, USA.'}, {'ForeName': 'Nayeli', 'Initials': 'N', 'LastName': 'Gonzalez', 'Affiliation': 'Cancer Resource Center of the Desert, 444 So. 8th St, Suite B-3, El Centro, California, USA.'}, {'ForeName': 'Silvia Araceli', 'Initials': 'SA', 'LastName': 'Cervantes', 'Affiliation': 'Kaweah Delta Health Care District, 400 W. Mineral King, Visalia, California, USA.'}, {'ForeName': 'Vicken Y', 'Initials': 'VY', 'LastName': 'Totten', 'Affiliation': 'Kaweah Delta Health Care District, 400 W. Mineral King, Visalia, California, USA.'}]",Psycho-oncology,['10.1002/pon.5481']
2850,32667858,A Specific Mobile Health Application for Older HIV-Infected Patients: Usability and Patient's Satisfaction.,"Background:   HIV infection is an increasingly complex chronic disease associated with numerous medical, psychological, and social problems. The life expectancy of affected patients has increased considerably. Medical apps could also play a role in prevention and management of comorbid conditions in the HIV-infected population.   Objectives:   To determine the usefulness of an app designed specifically for HIV-infected patients aged 60 years or older and to assess changes in patient satisfaction, adherence to treatment, and quality of health care.   Methods:   A randomized clinical trial was conducted, including 100 patients (50 per group): (1) an experimental group comprising patients using the app + routine medical care (app group) and (2) with routine medical care (control group). The usability of the app and patient satisfaction were evaluated in the app group at week 48. Quality of life, adherence to treatment, and clinical parameters were compared between both groups at 48 weeks, as well as the number of face-to-face visits.   Results:   We found that 52.2% and 73.8% of patients in the app group used the app at weeks 24 and 48, respectively. Patients used the app for a mean of 23.7 (±2.84) days over the 48 weeks. The most visited screens were health counseling and medical records (24.8% and 22.2%, respectively). At week 48, 85.2% of patients thought that the app was useful and 91.4% would recommend the app to friends or relatives. The app was well valued by participants (4.79 [±0.21] of 5.00) and 64.6% thought that the app improved their health care.",2020,The app was well valued by participants (4.79 [±0.21] of 5.00) and 64.6% thought that the app improved their health care.,"['100 patients (50 per group): (1) an experimental group comprising patients using the app + routine medical care (app group) and (2) with routine medical care (control group', 'Older HIV-Infected Patients', 'HIV-infected patients aged 60 years or older']",[],"['Quality of life, adherence to treatment, and clinical parameters', 'patient satisfaction, adherence to treatment, and quality of health care', 'usability of the app and patient satisfaction', 'life expectancy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",100.0,0.0348329,The app was well valued by participants (4.79 [±0.21] of 5.00) and 64.6% thought that the app improved their health care.,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Echeverría', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lluch', 'Affiliation': 'Professor of Phychosocial and Mental Health Nursing, School of Nursing, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Herms', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Estany', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bonjoch', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Arelly', 'Initials': 'A', 'LastName': 'Ornelas', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'París', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Loste', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sarquella', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Bonaventura', 'Initials': 'B', 'LastName': 'Clotet', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}, {'ForeName': 'Eugènia', 'Initials': 'E', 'LastName': 'Negredo', 'Affiliation': 'Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0098']
2851,32668111,Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA.,"BACKGROUND


Trials have evaluated the use of clopidogrel and aspirin to prevent stroke after an ischemic stroke or transient ischemic attack (TIA). In a previous trial, ticagrelor was not better than aspirin in preventing vascular events or death after stroke or TIA. The effect of the combination of ticagrelor and aspirin on prevention of stroke has not been well studied.
METHODS


We conducted a randomized, placebo-controlled, double-blind trial involving patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy. The patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive a 30-day regimen of either ticagrelor (180-mg loading dose followed by 90 mg twice daily) plus aspirin (300 to 325 mg on the first day followed by 75 to 100 mg daily) or matching placebo plus aspirin. The primary outcome was a composite of stroke or death within 30 days. Secondary outcomes were first subsequent ischemic stroke and the incidence of disability within 30 days. The primary safety outcome was severe bleeding.
RESULTS


A total of 11,016 patients underwent randomization (5523 in the ticagrelor-aspirin group and 5493 in the aspirin group). A primary-outcome event occurred in 303 patients (5.5%) in the ticagrelor-aspirin group and in 362 patients (6.6%) in the aspirin group (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P = 0.02). Ischemic stroke occurred in 276 patients (5.0%) in the ticagrelor-aspirin group and in 345 patients (6.3%) in the aspirin group (hazard ratio, 0.79; 95% CI, 0.68 to 0.93; P = 0.004). The incidence of disability did not differ significantly between the two groups. Severe bleeding occurred in 28 patients (0.5%) in the ticagrelor-aspirin group and in 7 patients (0.1%) in the aspirin group (P = 0.001).
CONCLUSIONS


Among patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or endovascular thrombolysis, the risk of the composite of stroke or death within 30 days was lower with ticagrelor-aspirin than with aspirin alone, but the incidence of disability did not differ significantly between the two groups. Severe bleeding was more frequent with ticagrelor. (Funded by AstraZeneca; THALES ClinicalTrial.gov number, NCT03354429.).",2020,The incidence of disability did not differ significantly between the two groups.,"['patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy', 'group and 5493 in the aspirin group', '11,016 patients underwent randomization (5523 in the', 'Acute Ischemic Stroke or TIA', 'patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or']","['placebo', 'ticagrelor-aspirin', 'endovascular thrombolysis', 'Ticagrelor and Aspirin or Aspirin Alone', 'aspirin', 'placebo plus aspirin', 'clopidogrel and aspirin', 'ticagrelor and aspirin', 'ticagrelor']","['incidence of disability', 'severe bleeding', 'Severe bleeding', 'risk of the composite of stroke or death', 'subsequent ischemic stroke and the incidence of disability', 'composite of stroke or death within 30 days', 'Ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",11016.0,0.444595,The incidence of disability did not differ significantly between the two groups.,"[{'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916870']
2852,32672677,Comparative Evaluation of Phacoemulsification Alone versus Phacoemulsification with Goniosynechialysis in Primary Angle-Closure Glaucoma: A Randomized Controlled Trial.,"PURPOSE


Comparative evaluation of phacoemulsification (phaco) alone versus phacoemulsification combined with goniosynechialysis (phacoGSL) in primary angle-closure glaucoma (PACG).
DESIGN


Prospective, randomized, parallel group, active controlled trial.
PARTICIPANTS


Patients with PACG.
METHODS


A total of 120 consecutive patients with PACG were screened, of whom 80 met inclusion criteria, with PACG uncontrolled on maximal hypotensive therapy and were recruited. Patients were randomized into 2 groups and underwent phaco alone in group 1 or phacoGSL in group 2. The patients were examined at baseline and at 1 week and 1, 3, and 6 months. The anterior chamber angle parameters on swept-source anterior segment OCT (SS-ASOCT) were noted at 1 and 6 months.
MAIN OUTCOME MEASURES


The primary outcome measure was intraocular pressure (IOP) reduction. A reduction in IOP of ≥ 20% from baseline IOP with or without medications was considered a success. Secondary outcome measures included change in the anterior chamber angle temporal parameters, angle-opening distance, trabecular-iris space area and scleral spur angle, surgical safety, visual acuity, and reduction in the number of glaucoma medications postoperatively.
RESULTS


The average age of patients was 58.77±8.14 years and 56.50±9.17 years in groups 1 and 2, respectively (P = 0.31). The mean baseline IOP was 29.48±6.76 mmHg and 30.72±3.88 mmHg in groups 1 and 2, respectively (P = 0.13). Success was obtained in 93.33% of patients in group 1 and 91.18% of patients in group 2 at 6 months (P = 0.39). Mean IOP was 13.17±1.66 mmHg and 13.21±1.97 mmHg at 6 months in groups 1 and 2, respectively (P = 0.001). The reduction in IOP was 55.32% and 56.99% at 6 months in groups 1 and 2 (P = 0.48). Significant widening of the angle parameters was noted at 6 months with an increase compared with baseline values in both groups. In multivariate analysis, the significant predictor of decrease in IOP was the higher baseline IOP.
CONCLUSIONS


Both phaco and phacoGSL are associated with a significant reduction in IOP along with a noteworthy widening of the anterior chamber angle parameters. Both procedures succeeded in reducing the necessity of glaucoma medications postoperatively in PACG eyes. There is no additional benefit of phacoGSL over phaco in PACG.",2019,Success was obtained in 93.33% of patients in group 1 and 91.18% of patients in group 2 at 6 months (P = 0.39).,"['120 consecutive patients with PACG were screened, of whom 80 met inclusion criteria, with PACG uncontrolled on maximal hypotensive therapy and were recruited', 'Patients with PACG', 'primary angle-closure glaucoma (PACG', 'Primary Angle-Closure Glaucoma']","['phaco alone in group 1 or phacoGSL', 'Phacoemulsification Alone versus Phacoemulsification with Goniosynechialysis', 'phacoemulsification (phaco) alone versus phacoemulsification combined with goniosynechialysis (phacoGSL']","['Success', 'reduction in IOP', 'Mean IOP', 'intraocular pressure (IOP) reduction', 'change in the anterior chamber angle temporal parameters, angle-opening distance, trabecular-iris space area and scleral spur angle, surgical safety, visual acuity, and reduction in the number of glaucoma medications postoperatively', 'swept-source anterior segment OCT (SS-ASOCT', 'mean baseline IOP', 'Significant widening of the angle parameters', 'IOP']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1319428', 'cui_str': 'Hypotensive therapy'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229116', 'cui_str': 'Structure of scleral spur'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",120.0,0.0537448,Success was obtained in 93.33% of patients in group 1 and 91.18% of patients in group 2 at 6 months (P = 0.39).,"[{'ForeName': 'Dewang', 'Initials': 'D', 'LastName': 'Angmo', 'Affiliation': 'Glaucoma Research and Clinical Facility, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: dewang45@gmail.com.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Shakrawal', 'Affiliation': 'Glaucoma Research and Clinical Facility, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Barkha', 'Initials': 'B', 'LastName': 'Gupta', 'Affiliation': 'Glaucoma Research and Clinical Facility, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Glaucoma Research and Clinical Facility, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Tanuj', 'Initials': 'T', 'LastName': 'Dada', 'Affiliation': 'Glaucoma Research and Clinical Facility, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.05.004']
2853,32672800,Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: The EVEREST II Randomized Clinical Trial.,"Importance


The 2-year efficacy and safety of combination therapy of ranibizumab administered together with verteporfin photodynamic therapy (vPDT) compared with ranibizumab monotherapy in participants with polypoidal choroidal vasculopathy (PCV) are unclear.
Objective


To compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months.
Design, Setting, and Participants


This 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography.
Interventions


Participants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.
Main Outcomes and Measures


Evaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions.
Results


Among 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001). Participants in the combination group received fewer ranibizumab injections (median, 6.0 [interquartile range (IQR), 4.0-11.0]) than the monotherapy group (median, 12.0 [IQR, 7.0-17.0]) up to month 24. The combination group required a median of 2.0 (IQR, 1.0-3.0) vPDT treatments for 24 months, with 75 of 168 participants (44.6%) requiring only 1 vPDT treatment.
Conclusions and Relevance


The 24-month data findings confirm that ranibizumab therapy, given as monotherapy or in combination with vPDT, is efficacious and safe for treatment of PCV. Combination therapy with vPDT added to ranibizumab achieved superior BCVA gain, increased odds of complete polypoidal lesion regression, and fewer treatment episodes compared with ranibizumab monotherapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT01846273.",2020,Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001).,"['participants with polypoidal choroidal vasculopathy (PCV', 'Polypoidal Choroidal Vasculopathy', 'Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography', '322 participants (mean [SD] age', 'Interventions\n\n\nParticipants (N\u2009=\u2009322', 'participants with PCV for 24 months']","['vPDT', 'vPDT (combination group) or sham PDT (monotherapy', 'ranibizumab injections', 'ranibizumab', 'ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy', 'verteporfin photodynamic therapy (vPDT', 'ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n\u2009=\u2009168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy', 'Ranibizumab With or Without Verteporfin Photodynamic Therapy', 'ranibizumab monotherapy']","['superior BCVA gain', 'key clinical outcomes, treatment exposure, and safety', 'visual acuity (BCVA) gains', '2-year efficacy and safety', 'complete polypoidal lesion regression']","[{'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0430879', 'cui_str': 'Indocyanine green angiography'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0387288', 'cui_str': 'Verteporfin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",,0.24727,Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001).,"[{'ForeName': 'Tock H', 'Initials': 'TH', 'LastName': 'Lim', 'Affiliation': 'National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Timothy Y Y', 'Initials': 'TYY', 'LastName': 'Lai', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Tien Y', 'Initials': 'TY', 'LastName': 'Wong', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, National University of Singapore, Singapore.'}, {'ForeName': 'Lee-Jen', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Paisan', 'Initials': 'P', 'LastName': 'Ruamviboonsuk', 'Affiliation': 'Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Colin S', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': ""Department of Ophthalmology, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Chui Ming Gemmy', 'Initials': 'CMG', 'LastName': 'Cheung', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, National University of Singapore, Singapore.'}, {'ForeName': 'Nor Fariza', 'Initials': 'NF', 'LastName': 'Ngah', 'Affiliation': 'Department of Ophthalmology, Hospital Shah Alam, Malaysia.'}, {'ForeName': 'Ramune', 'Initials': 'R', 'LastName': 'Patalauskaite', 'Affiliation': 'Novartis Ireland Ltd, Dublin, Ireland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Margaron', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye & Retina Surgeons, Camden Medical Centre, Singapore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2443']
2854,32667902,Oral saline consumption and pressor responses to acute physical stress.,"Sodium induced volume loading may alter pressor responses to physical stress, an early symptom of cardiovascular disease.
PURPOSE


Study 1: Determine the time point where total blood volume and serum sodium were elevated following saline consumption. Study 2: Examine the BP response to isometric handgrip (HG) and the cold pressor test (CPT) following saline consumption.
METHODS


Study 1: Eight participants drank 423 mL of normal saline (sodium 154 mmol/L) and had blood draws every 30 min for 3 h. Study 2: Sixteen participants underwent two randomized data collection visits; a control and experimental visit 90 min following saline consumption. Participants underwent 2 min of isometric HG, post exercise ischemia (PEI), and CPT.
RESULTS


Study 1: Total blood volume (3.8 ± 3.0 Δ%) and serum sodium (3.5 ± 3.6 Δ%) were elevated (P < 0.05) by the 90 min time point. Study 2: There were no differences in mean arterial pressure (MAP) during HG (EXP: 17.4 ± 8.2 ΔmmHg; CON: 19.1 ± 6.0 ΔmmHg), PEI (EXP: 16.9 ± 11.7 ΔmmHg; CON: 16.9 ± 7.8 ΔmmHg), or the CPT (EXP: 20.3 ± 10.8 ΔmmHg; CON: 20.9 ± 11.7 ΔmmHg) between conditions (P > 0.05). MAP recovery from the CPT was slower following saline consumption (1 min recovery: EXP; 15.7 ± 7.9 ΔmmHg, CON; 12.3 ± 8.9 ΔmmHg, P < 0.05).
CONCLUSION


Data showed no difference in cardiovascular responses during HG or the CPT between conditions. BP recovery was delayed by saline consumption following the CPT.",2020,"There were no differences in mean arterial pressure (MAP) during HG (EXP: 17.4 ± 8.2 ΔmmHg; CON: 19.1 ± 6.0 ΔmmHg), PEI (EXP: 16.9 ± 11.7 ΔmmHg; CON: 16.9 ± 7.8 ΔmmHg), or the CPT (EXP: 20.3 ± 10.8 ΔmmHg; CON: 20.9 ± 11.7 ΔmmHg) between conditions (P > 0.05).","['acute physical stress', '154 mmol/L) and had blood draws every 30 min for 3 h. Study 2: Sixteen participants underwent two randomized data collection visits; a', 'Study 1: Eight participants drank 423 mL of']","['control and experimental visit 90 min following saline consumption', 'isometric HG, post exercise ischemia (PEI), and CPT', 'normal saline (sodium', 'isometric handgrip (HG) and the cold pressor test (CPT']","['mean arterial pressure (MAP', 'MAP recovery', 'cardiovascular responses', 'BP recovery', 'total blood volume and serum sodium', 'serum sodium', 'Total blood volume']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231302', 'cui_str': 'Physical stress'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0429890', 'cui_str': 'Total blood volume'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}]",,0.115986,"There were no differences in mean arterial pressure (MAP) during HG (EXP: 17.4 ± 8.2 ΔmmHg; CON: 19.1 ± 6.0 ΔmmHg), PEI (EXP: 16.9 ± 11.7 ΔmmHg; CON: 16.9 ± 7.8 ΔmmHg), or the CPT (EXP: 20.3 ± 10.8 ΔmmHg; CON: 20.9 ± 11.7 ΔmmHg) between conditions (P > 0.05).","[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Del Vecchio', 'Affiliation': 'Department of Exercise Science and Physical Education, Montclair State University, Montclair, NJ, USA.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Hosick', 'Affiliation': 'Department of Exercise Science and Physical Education, Montclair State University, Montclair, NJ, USA.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Matthews', 'Affiliation': 'Department of Exercise Science and Physical Education, Montclair State University, Montclair, NJ, USA.'}]",Physiology international,['10.1556/2060.2020.00018']
2855,32667923,WaSH CQI: Applying continuous quality improvement methods to water service delivery in four districts of rural northern Ghana.,"Continuous, safely managed water is critical to health and development, but rural service delivery faces complex challenges in low- and middle-income countries (LMICs). We report the first application of continuous quality improvement (CQI) methods to improve the microbial quality of household water for consumption (HWC) and the functionality of water sources in four rural districts of northern Ghana. We further report on the impacts of interventions developed through these methods. A local CQI team was formed and trained in CQI methods. Baseline data were collected and analyzed to identify determinants of service delivery problems and microbial safety. The CQI team randomized communities, developed an improvement package, iteratively piloted it in intervention communities, and used uptake survey data to refine the package. The final improvement package comprised safe water storage containers, refresher training for community WaSH committees and replacement of missing maintenance tools. This package significantly reduced contamination of HWC (p<0.01), and significant reduction in contamination persisted two years after implementation. Repair times in both intervention and control arms decreased relative to baseline (p<0.05), but differences between intervention and control arms were not significant at endline. Further work is needed to build on the gains in household water quality observed in this work, sustain and scale these improvements, and explore applications of CQI to other aspects of water supply and sanitation.",2020,"This package significantly reduced contamination of HWC (p<0.01), and significant reduction in contamination persisted two years after implementation.","['four rural districts of northern Ghana', 'four districts of rural northern Ghana']","['WaSH CQI', 'continuous quality improvement (CQI']","['Repair times', 'microbial quality of household water for consumption (HWC', 'contamination of HWC']","[{'cui': 'C0017516', 'cui_str': 'Ghana'}]","[{'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",4.0,0.0294095,"This package significantly reduced contamination of HWC (p<0.01), and significant reduction in contamination persisted two years after implementation.","[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Fisher', 'Affiliation': 'Department of Environmental Sciences and Engineering, The Water Institute at UNC, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Danquah', 'Affiliation': 'School of Geosciences, University of Energy and Natural Resources, Sunyani, Ghana.'}, {'ForeName': 'Zakaria', 'Initials': 'Z', 'LastName': 'Seidu', 'Affiliation': 'West African Centre for Cell Biology of Infectious Pathogens, University of Ghana, Legon, Ghana.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Fechter', 'Affiliation': 'The Water Project, Concord, NH, United States of America.'}, {'ForeName': 'Bansaga', 'Initials': 'B', 'LastName': 'Saga', 'Affiliation': 'Solidarites International, Clichy, France.'}, {'ForeName': 'Jamie K', 'Initials': 'JK', 'LastName': 'Bartram', 'Affiliation': 'Department of Environmental Sciences and Engineering, The Water Institute at UNC, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Kaida M', 'Initials': 'KM', 'LastName': 'Liang', 'Affiliation': 'Department of Environmental Sciences and Engineering, The Water Institute at UNC, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Ramaswamy', 'Affiliation': 'Public Health Leadership Program, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0233679']
2856,32667956,Improved balance in middle-aged adults after 8 weeks of a modified version of Otago Exercise Program: A randomized controlled trial.,"OBJECTIVE


The objective of this randomized controlled trial was to examine dynamic balance changes (reach distance) in middle-aged adults using the Y Balance Test (YBT) following 8 weeks of home-based exercise program adapted from the Otago Exercise Program (OEP).
METHODS


Fifty-two healthy middle-aged adults with mean age of 54.4±5.4 years and body mass index of 27.7±5.7 kg/m2 were randomly assigned into either the exercise group (a modification of the Otago Exercise Program, that consisted of home-based balance and strength exercises) or the non-exercise group (continuation of usual lifestyle) by having the participants select a paper from a sealed envelope. The YBT was used to measure participants' dynamic balance in the right and left anterior (RA, LA), posteromedial (RPM, LPM), and posterolateral (RPL, LPL) directions.
RESULTS


The outcome in this trial was reach distance (cm). There was a significant group by time interaction in terms of reach distance for all directions (p<0.05, η2 ranged from 0.06 to 0.20). In the exercise group, results of the repeated measures analysis of variance (ANOVA) showed significant improvements in the reach distance in all the directions (p<0.001). In contrast, the non-exercise group had significant difference only in the left posterolateral direction (p = 0.009). Participants in the exercise group achieved significantly greater reach distance (cm) (95% confidence interval (CI)) for RA[(2.8, 0.4 to 5.2), p = 0.023]; LA[(3.2, 0.9 to 5.6), p = 0.008]; RPM[(4.0, 1.0 to 7.9), p = 0.046]; LPM[(5.8,1.3 to 10.3), p = 0.013]; RPL[(7.6, 2.6 to 12.6), p = 0.003]; and LPL[(4.2, 0.3 to 8.2), p = 0.035].
CONCLUSION


The modified version of OEP appears to be effective in improving parameters of dynamic balance in the middle-aged adult population. The improvements in YBT reach distance in the exercise group are indicative of the significance of performing balance and strength exercises regularly for this population.",2020,The modified version of OEP appears to be effective in improving parameters of dynamic balance in the middle-aged adult population.,"['middle-aged adult population', 'middle-aged adults', 'middle-aged adults using the Y Balance Test (YBT) following 8 weeks of', 'Fifty-two healthy middle-aged adults with mean age of 54.4±5.4 years and body mass index of 27.7±5.7 kg/m2']","['exercise group (a modification of the Otago Exercise Program, that consisted of home-based balance and strength exercises) or the non-exercise group (continuation of usual lifestyle) by having the participants select a paper from a sealed envelope', 'home-based exercise program adapted from the Otago Exercise Program (OEP', 'YBT']","['reach distance (cm', 'left posterolateral direction', 'YBT reach distance', 'greater reach distance (cm', 'dynamic balance changes (reach distance']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",52.0,0.0643444,The modified version of OEP appears to be effective in improving parameters of dynamic balance in the middle-aged adult population.,"[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Almarzouki', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Gurinder', 'Initials': 'G', 'LastName': 'Bains', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Lohman', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bradley', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Nelson', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Samiah', 'Initials': 'S', 'LastName': 'Alqabbani', 'Affiliation': 'Department of Rehabilitation Sciences, School of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alonazi', 'Affiliation': 'Department of Physical Therapy, School of Applied Medical Sciences, Majmaah University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Daher', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0235734']
2857,32667982,Adjunctive Daptomycin in the Treatment of Methicillin-Susceptible Staphylococcus aureus Bacteremia: A Randomized Controlled Trial.,"BACKGROUND


Bloodstream infections (BSI) with methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine the efficacy of synergistic treatment of daptomycin when given with either cefazolin or cloxacillin for the treatment of MSSA BSI.
METHODS


A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days.
RESULTS


Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0).
CONCLUSION


Among patients with MSSA bloodstream infections, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia and should not be routinely considered.",2020,"The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40).","['two academic hospitals in Montreal, Canada', 'Methicillin-Susceptible Staphylococcus aureus Bacteremia', 'Patients ≥ 18 years of age with MSSA BSI receiving either', '318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female', 'patients with MSSA bloodstream infections']","['adjunctive daptomycin therapy to standard of care treatment', 'cefazolin or cloxacillin', 'adjunctive daptomycin or placebo', 'daptomycin', 'Adjunctive Daptomycin', 'cefazolin or cloxacillin monotherapy', 'placebo']","['median duration of bacteremia', 'Ninety-day mortality', 'duration of bacteremia', 'duration of MSSA BSI in days']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1635274', 'cui_str': 'Methicillin susceptible Staphylococcus aureus'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1635274', 'cui_str': 'Methicillin susceptible Staphylococcus aureus'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}]",115.0,0.719674,"The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40).","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': ""Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lawandi', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Butler-Laporte', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': ""De l'Etoile-Morel"", 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Katryn', 'Initials': 'K', 'LastName': 'Paquette', 'Affiliation': ""Division of Neonatology, Montreal Children's Hospital, McGill University, Montreal, Canada.""}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, McGill University, Montreal, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1000']
2858,32668005,Effectiveness of a Technology-Enhanced Integrated Care Model for Frail Older People: A Stepped-Wedge Cluster Randomized Trial in Nursing Homes.,"BACKGROUND AND OBJECTIVES


The objective of this study was to evaluate the impact of an information and communication technologies- (ICT-) enhanced, multidisciplinary integrated care model, called Systems for Person-centered Elder Care (SPEC), on frail older adults at nursing homes.
RESEARCH DESIGN AND METHODS


SPEC was implemented at ten nursing homes in South Korea in random order using a stepped-wedge design. Data were collected on all participating older residents in the homes before the first implementation and until six months after the last implementation. The 21-month SPEC intervention guided by the chronic care model (CCM) consists of five strategies: comprehensive geriatric assessment, care planning, optional interdisciplinary case conferences, care coordination, and a cloud-based ICT tool along with free messaging app. The primary outcome was quality of care measured by a composite quality indicator (QI) from the interRAI assessment system. Usual care continued over the control periods. Nursing home staff were not blinded to the intervention.
RESULTS


There were a total of 482 older nursing home residents included in the analysis. Overall quality of care measured by the composite QI was significantly improved (adjusted mean difference: -0.025 [95% CI: -0.037 ~ -0.014, p <.0001]). The intervention effect was consistent in the subgroup analysis by cognition and activities of daily living. There were no important adverse events or side effects.
DISCUSSION AND IMPLICATIONS


The SPEC, a CCM-guided, ICT-supported, multidisciplinary integrated care management intervention, can improve quality of care measured by health and functional outcomes for frail older persons residing in nursing homes with limited healthcare provision.
TRIAL REGISTRATION


ISRCTN11972147; ethical approval: Seoul National University University Institutional Review Board.",2020,Overall quality of care measured by the composite QI was significantly improved (adjusted mean difference: -0.025,"['SPEC was implemented at ten nursing homes in South Korea in random order using a stepped-wedge design', 'participating older residents in the homes before the first implementation and until six months after the last implementation', 'frail older persons residing in nursing homes with limited healthcare provision', 'Frail Older People', '482 older nursing home residents included in the analysis', 'Nursing Homes', 'frail older adults at nursing homes']","['information and communication technologies', 'multidisciplinary integrated care model, called Systems for Person-centered Elder Care (SPEC', 'SPEC intervention guided by the chronic care model (CCM) consists of five strategies: comprehensive geriatric assessment, care planning, optional interdisciplinary case conferences, care coordination, and a cloud-based ICT tool along with free messaging app', 'Technology-Enhanced Integrated Care Model']","['Overall quality of care measured by the composite QI', 'cognition and activities of daily living', 'quality of care measured by a composite quality indicator (QI) from the interRAI assessment system']","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0556657', 'cui_str': 'Case conference'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",482.0,0.0605142,Overall quality of care measured by the composite QI was significantly improved (adjusted mean difference: -0.025,"[{'ForeName': 'Hongsoo', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Professor at Graduate School of Public Health, Dept. of Public Health Sciences; Institute of Aging; Institute of Health and Environment; Seoul National University, Gwanak-ro, Gwanak-gu, Seoul, South Korea.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Jung', 'Affiliation': 'Assistant Professor at Department of Environmental Health, Korea National Open University, 86 Dongsung-Dong, Chongno-Gu, Seoul, South Korea.'}, {'ForeName': 'Gi-Soo', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Post-doctoral Researcher, Dept. of Statistics, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, South Korea.'}, {'ForeName': 'Hyoungshim', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Assistant Professor at College of Nursing, Hansei University, 30 Hanse-ro, Dangjeong-dong, Gunpo-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yeon-Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Professor at College of Nursing, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, South Korea.'}]",The Gerontologist,['10.1093/geront/gnaa090']
2859,32668456,"Efficacy and safety of albendazole in hookworm-infected preschool-aged children, school-aged children and adults in Côte d'Ivoire: a phase II randomized controlled dose-finding trial.","BACKGROUND


Infections with hookworms affect about half a billion people worldwide. Recommended therapy includes 400 mg of albendazole, which is moderately efficacious. Higher doses have been rarely assessed.
METHODS


A randomized controlled dose-finding trial was conducted in a low transmission setting in Côte d'Ivoire aiming to recruit 120 preschool-aged children (PSAC), 200 school-aged children (SAC) and 200 adults. Eligible PSAC were randomized 1:1:1 to 200 mg, 400 mg, or 600 mg of albendazole, the other age groups 1:1:1:1:1 to placebo or 200 mg, 400 mg, 600 mg, or 800 mg. The primary outcome was cure rates (CRs) assessed 14-21 days post-treatment by quadruplicate Kato-Katz thick smears. Hyperbolic Emax models were used to determine dose-response.
RESULTS


38 PSAC, 133 SAC, and 196 adults were enrolled. In adults, predicted CRs increased with ascending doses of albendazole with a CR of 74.9% (95% Confidence Interval: 55.6%-87.7%) in the 800 mg arm. Observed CRs increased with ascending doses of albendazole and reached a maximum of 94.1% (95% CI: 80.3%-99.3%). In SAC, the predicted dose-response curve increased marginally with CRs ranging from 64.0% in the 200 mg to 76.0% in the 800 mg arm. Sample size in PSAC was considered too small to derive meaningful conclusions. Only 10.7% and 5.1% of participants reported any adverse event at 3 hours and 24 hours post-treatment, respectively.
CONCLUSIONS


A single 800 mg albendazole dose provides higher efficacy against hookworm and is well tolerated in adults and should be considered for community-based strategies targeting adults. For PSAC/SAC, current recommendations suffice.",2020,"Only 10.7% and 5.1% of participants reported any adverse event at 3 hours and 24 hours post-treatment, respectively.
","['38 PSAC, 133 SAC, and 196 adults were enrolled', ""hookworm-infected preschool-aged children, school-aged children and adults in Côte d'Ivoire"", '120 preschool-aged children (PSAC), 200 school-aged children (SAC) and 200 adults']","['albendazole', 'placebo']","['Efficacy and safety', 'adverse event', 'cure rates (CRs', 'Observed CRs', 'CRs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.451311,"Only 10.7% and 5.1% of participants reported any adverse event at 3 hours and 24 hours post-treatment, respectively.
","[{'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jean T', 'Initials': 'JT', 'LastName': 'Coulibaly', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hofmann', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': ""N'Gbesso"", 'Affiliation': ""Centre de Santé Urbain d'Azaguié, Department de Agboville, Côte d'Ivoire.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'University of Basel, Basel Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Keiser', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa989']
2860,32668474,Endoscopic submucosal dissection with additional radiotherapy in the treatment of T1a esophageal squamous cell cancer: randomized controlled Trial.,"BACKGROUND


Endoscopic submucosal dissection (ESD) is effective for treating T1a early esophageal squamous cell carcinoma (ESCC). However, occasional recurrences are inevitable. This trial was designed to clarify the efficacy of combining ESD with additional radiotherapy in the treatment of T1a ESCC.
METHODS


Between January 2015 and September 2018, patients with early ESCC (T1aN0M0) following ESD were randomly assigned (1:1) to the radiotherapy group or non-radiotherapy group. Patients in the radiotherapy group received a median radiation dose of 59.4 Gy within 2 months after ESD. In the non-radiotherapy group, patients underwent regular follow-up only. Recurrence-free survival, cancer-specific survival, overall survival, and complications were evaluated.
RESULTS


70 patients completed the per-protocol treatment. Three patients in the non-radiotherapy group experienced intraluminal mucosal recurrence compared with none in the radiotherapy group. No local lymph node or distant metastases occurred in either group. The 3-year cumulative recurrence-free survival was 100 % in the radiotherapy group and 85.3 % in the non-radiotherapy group ( P  = 0.04; hazard ratio 0.08, 95 % confidence interval [CI] 0.01 - 0.86). However, there was no significant difference in RFS between the treatments within the T1a invasion subgroups ( P  > 0.05). No patient died in either group. Mucosal defects of more than three-quarters of the esophageal circumference were positively correlated with stenosis ( P  < 0.01; odds ratio 23.26, 95 %CI 4.04 - 133.86). No severe radiation toxicities were recorded.
CONCLUSIONS


Radiotherapy after ESD might be a safe and effective optional therapeutic strategy to prevent recurrence of T1a ESCC.",2020,"The 3-year cumulative recurrence-free survival was 100 % in the radiotherapy group and 85.3 % in the non-radiotherapy group ( P  = 0.04; hazard ratio 0.08, 95 % confidence interval [CI] 0.01 - 0.86).","['T1a esophageal squamous cell cancer', 'Between January 2015 and September 2018, patients with early ESCC (T1aN0M0) following ESD', 'T1a ESCC', 'T1a early esophageal squamous cell carcinoma (ESCC']","['Endoscopic submucosal dissection with additional radiotherapy', 'ESD with additional radiotherapy', 'radiotherapy', 'Endoscopic submucosal dissection (ESD', 'radiotherapy group or non-radiotherapy group']","['esophageal circumference', '3-year cumulative recurrence-free survival', 'Recurrence-free survival, cancer-specific survival, overall survival, and complications', 'Mucosal defects', 'intraluminal mucosal recurrence', 'severe radiation toxicities', 'local lymph node or distant metastases', 'RFS']","[{'cui': 'C0475383', 'cui_str': 'Tumor stage T1a'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",,0.164958,"The 3-year cumulative recurrence-free survival was 100 % in the radiotherapy group and 85.3 % in the non-radiotherapy group ( P  = 0.04; hazard ratio 0.08, 95 % confidence interval [CI] 0.01 - 0.86).","[{'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Liansong', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hongze', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xianglei', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Zhou', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}]",Endoscopy,['10.1055/a-1198-5232']
2861,32668475,High-impact Routines to Ameliorate Trunk and Lower Limbs Flexibility in Women.,"Several types of routines and methods have been experimented to gain neuro/muscular advantages, in terms of overall range of motion, in athletes and fitness enthusiasts. The aim of the present study was to evaluate the impact of different routines on trunk- and lower limbs flexibility in a sample of young women. In a randomized-crossover fashion, eleven subjects underwent to: hamstrings stretching [S]; hamstrings stretching plus whole-body vibration [S+WBV]; partial-body cryotherapy [Cryo]; rest [Control]. Standing hamstrings stretch performance and sit-and-reach amplitude resulted to be improved with [S+WBV] compared to all other protocols (p<0.05). [Cryo] ameliorated the active knee extension performance with respect to all other interventions (p<0.05). These flexibility improvements were obtained without a loss in the trunk position sense proprioception. These results represent the first evidence that a single session of either vibration or cryotherapy can ameliorate flexibility without losing the trunk position sense proprioception in young women.",2020,Standing hamstrings stretch performance and sit-and-reach amplitude resulted to be improved with [S+WBV] compared to all other protocols (p<0.05).,"['eleven subjects underwent to', 'Women', 'young women']","['vibration or cryotherapy', 'hamstrings stretching [S]; hamstrings stretching plus whole-body vibration [S+WBV]; partial-body cryotherapy [Cryo]; rest [Control']","['active knee extension performance', 'flexibility improvements']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0556829', 'cui_str': 'Hamstring stretching'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",11.0,0.0212043,Standing hamstrings stretch performance and sit-and-reach amplitude resulted to be improved with [S+WBV] compared to all other protocols (p<0.05).,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Nardi', 'Affiliation': 'Cryotherapy Lab, Krioplanet Ltd, Treviglio (BG), Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Facheris', 'Affiliation': 'Cryotherapy Lab, Krioplanet Ltd, Treviglio (BG), Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruggeri', 'Affiliation': 'Department of Experimental Medicine, University of Genoa, Genova, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Codella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}]",International journal of sports medicine,['10.1055/a-1119-7902']
2862,32668476,Effect of Velocity Loss on Strength Performance in Bench Press Using a Weight Stack Machine.,"This study aimed to analyze the effects of three different velocity loss thresholds (10%: VL10, 30%: VL30 and 50%: VL50) on maximal strength and velocity at different intensities during bench press using a weight stack machine (WSM-BP). Forty-five men were randomly assigned to three groups: VL10 (n=15), VL30 (n=15) and VL50 (n=15), which followed a 5-week (15 sessions) velocity-based WSM-BP program. Assessments performed Pre- and Post-training included: a) estimated one-repetition maximum (1RM) in WSM-BP; b) average velocity attained against all absolute loads common to Pre- and Post-training tests in WSM-BP; c) average velocity attained against all absolute loads that were lifted equal to or faster than 0.8 m·s-1 at Pre-training (light loads); and d) average velocity attained against all absolute loads that were lifted slower than 0.8 m·s-1 at Pre-training (heavy loads). All groups showed significant improvements in 1RM, velocity against all loads, and velocity against heavy loads (P<0.001-0.01). However, only the VL10 group showed significant enhancements in velocity against light loads (P=0.05). Therefore, the VL10 group showed a higher training efficiency compared to VL30 and VL50 interventions, since it obtained similar benefits by performing fewer repetitions.",2020,"All groups showed significant improvements in 1RM, velocity against all loads, and velocity against heavy loads (P<0.001-0.01).",['Forty-five men'],"['VL30 (n=15) and VL50', 'VL10', 'VL10, 30%: VL30 and 50%: VL50']","['repetition maximum (1RM) in WSM-BP; b) average velocity attained against all absolute loads common to Pre- and Post-training tests in WSM-BP; c) average velocity attained against all absolute loads', 'maximal strength and velocity', 'velocity against light loads', '1RM, velocity against all loads, and velocity against heavy loads']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0242537', 'cui_str': 'Navigator Islands'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]",45.0,0.0248166,"All groups showed significant improvements in 1RM, velocity against all loads, and velocity against heavy loads (P<0.001-0.01).","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Rodiles-Guerrero', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'León-Prados', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville, Spain.'}]",International journal of sports medicine,['10.1055/a-1179-5849']
2863,32668482,Erratum: Effects of Sustained Inflation or Positive Pressure Ventilation on the Release of Adrenomedullin in Preterm Infants with Respiratory Failure at Birth.,,2019,,['Preterm Infants with Respiratory Failure at Birth'],['Sustained Inflation or Positive Pressure Ventilation'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]",[],,0.0385335,,"[{'ForeName': 'Azzurra La', 'Initials': 'A', 'LastName': 'Verde', 'Affiliation': ""Neonatal Intensive Care Unit, V. Buzzi Children's Hospital, ASST-FBFSacco, Milan, Italy.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Franchini', 'Affiliation': ""Neonatal Intensive Care Unit, G. D'Annunzio University of Chieti, Chieti, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lapergola', 'Affiliation': ""Neonatal Intensive Care Unit, G. D'Annunzio University of Chieti, Chieti, Italy.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lista', 'Affiliation': ""Neonatal Intensive Care Unit, V. Buzzi Children's Hospital, ASST-FBFSacco, Milan, Italy.""}, {'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Barbagallo', 'Affiliation': 'Department of Biomedical and Biotechnological Sciences Section of Biochemistry, University of Catania, Catania, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Livolti', 'Affiliation': 'Department of Biomedical and Biotechnological Sciences Section of Biochemistry, University of Catania, Catania, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Gazzolo', 'Affiliation': ""Neonatal Intensive Care Unit, G. D'Annunzio University of Chieti, Chieti, Italy.""}]",American journal of perinatology,['10.1055/s-0040-1714104']
2864,32668666,"An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial.","The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow's milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF ( n  = 134) or IPF ( n  = 134) from ≤14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/-3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means -1.2 g/d; 90% CI (-2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula; it is also safe for use and well-tolerated in healthy term infants.",2020,"No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups.","['healthy term infants', ""intact cow's milk protein formula (IPF"", 'infants whose mothers intended to fully formula feed']","['partially hydrolyzed whey protein-based infant formula (PHF', 'PHF', 'IPF']","['recorded adverse events, growth and gastro-intestinal tolerance parameters', 'weight gain', 'growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes', 'safety and tolerance']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.262772,"No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups.","[{'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Picaud', 'Affiliation': 'Hospices Civils de Lyon; Neonatal Intensive Care Unit, Hôpital de la Croix Rousse, 69004 Lyon, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pajek', 'Affiliation': 'NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska, 41-103 Siemianowice-Slaskie, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Arciszewska', 'Affiliation': 'Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k, 15-435 Bialystok, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Tarczón', 'Affiliation': 'Specjalistyczna Poradnia Medyczna Przylądek Zdrowia, 31-589 Kraków, Poland.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Escribano', 'Affiliation': 'Hospital Universitari Sant Joan de Reus, 43204 Reus, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Porcel', 'Affiliation': 'Hospital Quirónsalud Barcelona, 08023 Barcelona, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Adelt', 'Affiliation': 'Paediatric Practice, 49565 Bramsche, Germany.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Hassink', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Rijnierse', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Abrahamse-Berkeveld', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Korczowski', 'Affiliation': 'Department of Pediatrics and Pediatric Gastroenterology, College of Medical Sciences, University of Rzeszów, 35-302 Rzeszów, Poland.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Tenuto Study Group', 'Affiliation': ''}]",Nutrients,['10.3390/nu12072072']
2865,32668743,Assessment of Mortality and Factors Affecting Outcome of Use of Paclitaxel-Coated Stents and Bare Metal Stents in Femoropopliteal PAD.,"The use of drug-coated devices in intravascular therapy is aimed at preventing neointimal hyperplasia caused by excessive proliferation of vascular smooth muscle and thereby restenosis. Although its use seemed initially promising, a recent publication has shown an increased risk of mortality with paclitaxel-coated devices, and there is an urgent need to reaffirm assessments of drug-eluting stents (DES).
OBJECTIVE


The aim of the study was to compare mortality and effectiveness of paclitaxel-coated stents and bare-metal stents (BMS) in the treatment of peripheral arterial disease (PAD) with long-term follow-up.
MATERIALS AND METHODS


In a single center randomized study, 256 patients with PAD were treated intravascularly with stent implantation. Patients were randomized into two groups: the first (n = 126) were treated with DES, and the second (n = 130) were treated with BMS. The study included evaluation after the procedure, after about 6 months and 36 months. Co-morbidities, with risks for atherosclerosis, were analyzed in all patients. Patients were evaluated for clinical outcome, restenosis frequency, and safety (complications and total mortality).
RESULTS


Clinical benefit at the end of the investigation was statistically significantly better in the DES group compared with the BMS group: 85.7% versus 66.2% ( p  = 0.0003), respectively. Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%,  p  = 0.012. There was no significant effect of comorbidities on the frequency of restenoses. There were no differences in all-cause mortality over the three years with paclitaxel and no-paclitaxel stents cohorts (8.7% versus 7.1%; long-rank  p  = 0.575). No association was found with mortality and treatment with DES or BMS.
CONCLUSIONS


The use of paclitaxel-coated stents gave good clinical benefit and caused a significantly lower frequency of restenosis compared to bare-metal stents. The use of paclitaxel-coated stents did not increase mortality.",2020,"Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%,  p  = 0.012.","['Femoropopliteal PAD', '256 patients with PAD', 'peripheral arterial disease (PAD']","['BMS', 'stent implantation', 'Paclitaxel-Coated Stents and Bare Metal Stents', 'paclitaxel-coated stents and bare-metal stents (BMS', 'paclitaxel-coated stents']","['frequency of restenosis', 'clinical outcome, restenosis frequency, and safety (complications and total mortality', 'mortality and effectiveness', 'frequency of restenoses', 'mortality', 'Restenosis', 'cause mortality']","[{'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",256.0,0.0305396,"Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%,  p  = 0.012.","[{'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Falkowski', 'Affiliation': 'Department of Interventional Radiology, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Bogacki', 'Affiliation': 'Department of Interventional Radiology, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Szemitko', 'Affiliation': 'Department of Interventional Radiology, Pomeranian Medical University, 70-111 Szczecin, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9072221']
2866,32668823,Effects of α-tocopherol on hemolysis and oxidative stress markers on red blood cells in β-thalassemia major.,"Background


The accumulation of unpaired α-globin chains in patients with β-thalassemia major may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, is a potent scavenger of lipid radicals in the membranes of red blood cells (RBCs) of patients with β-thalassemia major.
Purpose


To evaluate the effects of α-tocopherol on hemolysis and oxidative stress markers on the RBC membranes of patients with β-thalassemia major.
Methods


Forty subjects included in this randomized controlled trial were allocated to the placebo and α-tocopherol groups. Doses of α-tocopherol were based on Institute of Medicine recommendations: 4-8 years old, 200 mg/day; 9-13 years old, 400 mg/day; 14-18 years old, 600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4-week α-tocopherol or placebo treatment, performed before blood transfusions.
Results


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021). However, there was no significant intergroup difference in osmotic fragility test results; hemopexin, malondialdehyde, reduced glutathione (GSH), or oxidized glutathione (GSSG) levels; or GSH/GSSG ratio.
Conclusion


Use of α-tocopherol could indirectly improve hemolysis and haptoglobin levels. However, it played no significant role in oxidative stress or as an endogen antioxidant marker in β-thalassemia major.",2020,"Results


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021).","['Methods\n\n\nForty subjects', 'β-thalassemia major', 'patients with β-thalassemia major']","['α-tocopherol or placebo', 'placebo and α-tocopherol', 'α-tocopherol']","['hemolysis and haptoglobin levels', 'oxidative stress', 'Hemolysis, oxidative stress, and antioxidant variables', 'plasma haptoglobin', 'osmotic fragility test results; hemopexin, malondialdehyde, reduced glutathione (GSH), or oxidized glutathione (GSSG) levels; or GSH/GSSG ratio']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0018595', 'cui_str': 'Haptoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0029392', 'cui_str': 'Osmotic fragility'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019067', 'cui_str': 'Hemopexin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0385745,"Results


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021).","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Sovira', 'Affiliation': 'Division of Pediatric Emergency & Intensive Care, Department of Pediatrics, Faculty of Medicine, University of Syiah Kualal/Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia.'}, {'ForeName': 'Munar', 'Initials': 'M', 'LastName': 'Lubis', 'Affiliation': 'Division of Pediatric Emergency & Intensive Care, Department of Pediatrics, Faculty of Medicine, University of Sumatera Utara/University of Sumatera Utara Hospital, Medan, Indonesia.'}, {'ForeName': 'Pustika Amalia', 'Initials': 'PA', 'LastName': 'Wahidiyat', 'Affiliation': 'Division of Hematology Oncology, Department of Pediatrics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Franciscus D', 'Initials': 'FD', 'LastName': 'Suyatna', 'Affiliation': 'Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Djajadiman', 'Initials': 'D', 'LastName': 'Gatot', 'Affiliation': 'Division of Hematology Oncology, Department of Pediatrics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Saptawati', 'Initials': 'S', 'LastName': 'Bardosono', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sadikin', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}]",Clinical and experimental pediatrics,['10.3345/cep.2019.00542']
2867,32668833,"Randomized, controlled trial comparing respiratory and analgesic effects of interscalene block, anterior suprascapular, and posterior suprascapular nerve block for arthroscopic shoulder surgeries.","Background


Interscalene brachial plexus block (ISB) provides excellent analgesia for arthroscopic shoulder surgeries but is associated with adverse effects including hemidiaphragmatic paresis from phrenic nerve blockade. The primary aim is to compare the respiratory effects, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1), of suprascapular nerve block (SSB) with ISB.
Methods


Sixty patients were recruited after taking informed consent and randomized into 3 groups, ISB, anterior and posterior SSB. FVC, FEV1 and diaphragmatic excursion were evaluated at baseline and 30 minutes after intervention. Blocks were performed under ultrasound guidance with 15 ml of 0.5% ropivacaine. Pain scores were assessed at 6, 12 and 24 hours post-operatively.
Results


The ISB group had a reduction of forced vital capacity of mean (SD), 31.2% (17.5) while the anterior and posterior SSB groups had significantly lower reduction of 3.6% (18.6) and 6.8% (6.5) respectively, p<0.001. Similarly, the diaphragmatic excursion in the ISB group decreased more than the anterior and posterior SSB groups; median (IQR) %, -85.7 (-95.3 to -63.3) vs -1.8 (-13.1 to 2.3) and -1.2 (-8.8 to 16.8), p<0.001. Median pain scores (IQR) in ISB and anterior SSB groups were lower than the posterior SSB group at 6 hours on movement, 0 (0-2), 1.8 (0-4.5) vs 5(2.5-8), p=0.002. There were no statistically significant differences in oxycodone consumption post-operatively.
Conclusions


Anterior SSB preserves lung function compared to ISB and has a comparable analgesic effect. It is recommended for arthroscopic shoulder surgeries, especially in patients who have reduced lung function.",2020,"Median pain scores (IQR) in ISB and anterior SSB groups were lower than the posterior SSB group at 6 hours on movement, 0","['patients who have reduced lung function', 'arthroscopic shoulder surgeries', 'Methods\n\n\nSixty patients']","['interscalene block, anterior suprascapular, and posterior suprascapular nerve block', 'posterior SSB', 'ropivacaine', '\n\n\nInterscalene brachial plexus block (ISB']","['oxycodone consumption', 'diaphragmatic excursion', 'Median pain scores (IQR', 'respiratory effects, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1), of suprascapular nerve block (SSB', 'forced vital capacity of mean (SD', 'Pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0807569,"Median pain scores (IQR) in ISB and anterior SSB groups were lower than the posterior SSB group at 6 hours on movement, 0","[{'ForeName': 'Yean Chin', 'Initials': 'YC', 'LastName': 'Lim', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, 2 Simei Street 3, Changi General Hospital, Singapore 529889.'}, {'ForeName': 'Zhao Kun', 'Initials': 'ZK', 'LastName': 'Koo', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, 2 Simei Street 3, Changi General Hospital, Singapore 529889.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Ho', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, 2 Simei Street 3, Changi General Hospital, Singapore 529889.'}, {'ForeName': 'See Seong', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, 2 Simei Street 3, Changi General Hospital, Singapore 529889.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Manohara', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, 2 Simei Street 3, Changi General Hospital, Singapore 529889.'}, {'ForeName': 'Qian Jun', 'Initials': 'QJ', 'LastName': 'Tong', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Changi General Hospital, 2 Simei Street 3, Changi General Hospital, Singapore 529889.'}]",Korean journal of anesthesiology,['10.4097/kja.20141']
2868,32676977,"A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects.","BACKGROUND


The delta opioid receptor (DOR) has been identified as a therapeutic target for migraine, with DOR agonists exhibiting low abuse potential compared with conventional µ-opioid agonists. TRV250 is a novel small molecule agonist of the DOR that is preferentially selective for G-protein signaling, with relatively little activation of the β-arrestin2 post-receptor signaling pathway. This selectivity provides reduced susceptibility to proconvulsant activity seen with non-selective DOR agonists. TRV250 significantly reduced nitroglycerin-evoked hyperalgesia in rodents, indicating a potential utility in acute migraine without the risk of seizure activity or abuse potential.
OBJECTIVE


This trial evaluated the safety, tolerability, and pharmacokinetics of ascending dose levels of TRV250 administered subcutaneously (SC) and the relative bioavailability of TRV250 administered orally compared with SC administration.
METHODS


This was a two-part, single ascending dose study. Part A included four cohorts of healthy adults (N = 38). Each cohort was dosed on three occasions (placebo and two different dose levels of TRV250, allocated in randomized order and administered by SC route). In Part B, a single cohort of nine subjects received an oral dose of either TRV250 (n = 7) or placebo (n = 2) in a fed or fasted state. Serial blood samples were obtained for pharmacokinetic determination across a 24-h post-dose period. Safety assessments included clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing.
RESULTS


TRV250 was well tolerated. There were no serious adverse events (SAEs), and all AEs were mild in severity. Injection-site reactions and headache were the most common AEs. One subject was withdrawn from the study due to a TRV250-related AE of postural orthostatic tachycardia. There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects. No subject experienced abnormalities in EEGs or experienced a change from baseline in heart-rate-corrected QT interval (QTcF) > 60 ms, or an absolute QTcF interval > 480 ms at any post-dosing observation. Peak and total plasma exposure to TRV250 increased in a dose-proportional manner following 0.1-30 mg SC doses, with the mean half-life ranging from 2.39 to 3.76 h. Oral bioavailability of TRV250 ranged from 14% (fasting) to 19% (fed) relative to SC dosing, while administration with food increased the AUC but decreased the rate of absorption as reflected by a modest delay in median time to maximum concentration and a slight reduction in maximum concentration.
CONCLUSION


The findings from the first-in-human study support further evaluation of TRV250, a G-protein selective DOR agonist, in the treatment of acute migraine.",2020,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","['Part A included four cohorts of healthy adults (N\u2009=\u200938', 'Healthy Subjects']","['occasions (placebo', 'Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist', 'TRV250 administered subcutaneously (SC', 'TRV250', 'placebo']","['clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing', 'absolute QTcF interval\u2009', 'tolerated', 'rate of absorption', 'safety, tolerability, and pharmacokinetics', 'Peak and total plasma exposure to TRV250', 'physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs', 'serious adverse events (SAEs', 'nitroglycerin-evoked hyperalgesia', 'heart-rate-corrected QT interval (QTcF)\u2009']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.101361,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena, Inc., 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA. mfossler@trevena.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Schmith', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Greene', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lohmer', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Scientific Operations and Alliance Management, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Arscott', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'James', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}]",CNS drugs,['10.1007/s40263-020-00738-0']
2869,32677032,"The role of smartphone app ""WhatsApp"" on achievement motivation and social intelligence among female undergraduate students.","PURPOSE


This study investigates the effects of using a smartphone application (WhatsApp) on achievement motivation and social intelligence in female students at Taif University.
DESIGN AND METHODS


The sample comprised 60 undergraduate female students from a college of education. The design was a quasi-experimental nonequivalent (pretest and posttest) control group.
FINDINGS


Achievement motivation was significantly higher in the experimental group than the control group at posttest. However, no significant difference was found between the experimental and control groups in social intelligence at posttest.
PRACTICE IMPLICATIONS


Smartphones can increase student learning by fostering high-level skills and concepts.",2020,"FINDINGS


Achievement motivation was significantly higher in the experimental group than the control group at posttest.","['60 undergraduate female students from a college of education', 'female students at Taif University', 'female undergraduate students']","['smartphone app ""WhatsApp', 'smartphone application (WhatsApp']","['social intelligence', 'achievement motivation and social intelligence', 'Achievement motivation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C2717811', 'cui_str': 'Social Intelligence'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0119866,"FINDINGS


Achievement motivation was significantly higher in the experimental group than the control group at posttest.","[{'ForeName': 'Mariam H', 'Initials': 'MH', 'LastName': 'Alshaibani', 'Affiliation': 'Department of Psychology, Taif University, Taif, Saudi Arabia.'}, {'ForeName': 'Eman S', 'Initials': 'ES', 'LastName': 'Qusti', 'Affiliation': 'Department of Psychology, Taif University, Makkah, Saudi Arabia.'}]",Perspectives in psychiatric care,['10.1111/ppc.12582']
2870,32677037,Nutritional interventions for treating foot ulcers in people with diabetes.,"BACKGROUND


Foot ulcers in people with diabetes are non-healing, or poorly healing, partial, or full-thickness wounds below the ankle. These ulcers are common, expensive to manage and cause significant morbidity and mortality. The presence of a wound has an impact on nutritional status because of the metabolic cost of repairing tissue damage, in addition to the nutrient losses via wound fluid. Nutritional interventions may improve wound healing of foot ulcers in people with diabetes.
OBJECTIVES


To evaluate the effects of nutritional interventions on the healing of foot ulcers in people with diabetes.
SEARCH METHODS


In March 2020 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) that evaluated the effect of nutritional interventions on the healing of foot ulcers in people with diabetes.
DATA COLLECTION AND ANALYSIS


Two review authors, working independently, assessed included RCTs for their risk of bias and rated the certainty of evidence using GRADE methodology, using pre-determined inclusion and quality criteria.
MAIN RESULTS


We identified nine RCTs (629 participants). Studies explored oral nutritional interventions as follows: a protein (20 g protein per 200 mL bottle), 1 kcal/mL ready-to-drink, nutritional supplement with added vitamins, minerals and trace elements; arginine, glutamine and β-hydroxy-β-methylbutyrate supplement; 220 mg zinc sulphate supplements; 250 mg magnesium oxide supplements; 1000 mg/day omega-3 fatty acid from flaxseed oil; 150,000 IU of vitamin D, versus 300,000 IU of vitamin D; 250 mg magnesium oxide plus 400 IU vitamin E and 50,000 IU vitamin D supplements. The comparator in eight studies was placebo, and in one study a different dose of vitamin D. Eight studies reported the primary outcome measure of ulcer healing; only two studies reported a measure of complete healing. Six further studies reported measures of change in ulcer dimension, these studies reported only individual parameters of ulcer dimensions (i.e. length, width and depth) and not change in ulcer volume. All of the evidence identified was very low certainty. We downgraded it for risks of bias, indirectness and imprecision. It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, increases the proportion of ulcers healed at six months more than placebo (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.42 to 1.53). It is also uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement increases the proportion of ulcers healed at 16 weeks compared with placebo (RR 1.09, 95% CI 0.85 to 1.40). It is uncertain whether the following interventions change parameters of ulcer dimensions over time when compared with placebo; 220 mg zinc sulphate supplement containing 50 mg elemental zinc, 250 mg magnesium oxide supplement, 1000 mg/day omega-3 fatty acid from flaxseed oil supplement, magnesium and vitamin E co-supplementation and vitamin D supplementation. It is also uncertain whether 150,000 IU of vitamin D, impacts ulcer dimensions when compared with 300,000 IU of vitamin D. Two studies explored some of the secondary outcomes of interest for this review. It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, reduces the number of deaths (RR 0.96, 95% CI 0.06 to 14.60) or amputations (RR 4.82, 95% CI 0.24 to 95.88) more than placebo. It is uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement increases health-related quality of life at 16 weeks more than placebo (MD -0.03, 95% CI -0.09 to 0.03). It is also uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement reduces the numbers of new ulcers (RR 1.04, 95% CI 0.71 to 1.51), or amputations (RR 0.66, 95% CI 0.16 to 2.69) more than placebo. None of the included studies reported the secondary outcomes cost of intervention, acceptability of the intervention (or satisfaction) with respect to patient comfort, length of patient hospital stay, surgical interventions, or osteomyelitis incidence. One study exploring the impact of arginine, glutamine and β-hydroxy-β-methylbutyrate supplement versus placebo did not report on any relevant outcomes.
AUTHORS' CONCLUSIONS


Evidence for the impact of nutritional interventions on the healing of foot ulcers in people with diabetes compared with no nutritional supplementation, or compared with a different dose of nutritional supplementation, remains uncertain, with eight studies showing no clear benefit or harm. It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo. More research is needed to clarify the impact of nutritional interventions on the healing of foot ulcers in people with diabetes.",2020,"It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo.",['people with diabetes'],"['arginine, glutamine and β-hydroxy-β-methylbutyrate', 'magnesium oxide plus 400\u2009IU vitamin E and 50,000 IU vitamin D supplements', 'Nutritional interventions', 'nutritional interventions', 'kcal/mL ready-to-drink, nutritional supplement with added vitamins, minerals and trace elements; arginine, glutamine and β-hydroxy-β-methylbutyrate supplement; 220 mg zinc sulphate supplements; 250 mg magnesium oxide supplements; 1000 mg/day omega-3 fatty acid from flaxseed oil; 150,000 IU of vitamin D', 'magnesium oxide supplement, 1000 mg/day omega-3 fatty acid from flaxseed oil supplement, magnesium and vitamin E co-supplementation and vitamin D supplementation', 'vitamin D', 'arginine, glutamine and β-hydroxy-β-methylbutyrate supplement versus placebo', 'placebo']","['ulcer healing', 'health-related quality of life', 'wound healing of foot ulcers', 'numbers of new ulcers', 'complete healing', 'number of deaths', 'proportion of ulcers healed', 'healing of foot ulcers', 'acceptability of the intervention (or satisfaction) with respect to patient comfort, length of patient hospital stay, surgical interventions, or osteomyelitis incidence', 'rates of adverse events, amputation rate, development of new foot ulcers, or quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0560598', 'cui_str': 'kcal/mL'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023754', 'cui_str': 'Linseed Oil'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",,0.351557,"It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo.","[{'ForeName': 'Zena Eh', 'Initials': 'ZE', 'LastName': 'Moore', 'Affiliation': 'School of Nursing & Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Meave A', 'Initials': 'MA', 'LastName': 'Corcoran', 'Affiliation': 'Department of Endocrinology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Patton', 'Affiliation': 'School of Nursing & Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011378.pub2']
2871,32677051,The Effects of Ketamine on Typical and Atypical Depressive Symptoms.,"OBJECTIVE


Ketamine's effects on different dimensions of depressive symptomatology, including typical/melancholic and atypical depression, remain largely unknown. This study examined the effects of a single intravenous dose of ketamine on general depressive symptoms (measured using the Montgomery-Asberg Depression Rating Scale (MADRS), typical/melancholic symptoms (measured using the MADRS5), and atypical symptoms (measured using the Scale for Atypical Symptoms (SAS)).
METHODS


Data from 68 participants with treatment-resistant major depressive disorder (MDD) or bipolar depression were pooled from three separate, double-blind, placebo-controlled, crossover studies investigating ketamine's efficacy in depression. MDD participants were unmedicated; bipolar participants received therapeutic-dose lithium or valproate. Clinical symptoms were collected pre-infusion and up to 14 days post-infusion. Effect sizes were calculated for Days 1 and 3 post-infusion. The primary measures of interest for this exploratory analysis were total MADRS, MADRS5, and SAS scores. Individual symptoms were also analyzed in an exploratory manner.
RESULTS


Scores improved significantly at Day 1 post-infusion (MADRS: Cohen's d=0.64; MADRS5: Cohen's d=0.61; SAS: Cohen's d=0.41) and continued to be significantly improved over placebo at Day 3 (MADRS: Cohen's d=0.49; MADRS5: Cohen's d=0.43; SAS: Cohen's d=0.39). Effect sizes were greater for typical/melancholic than atypical symptoms at Day 1 post-infusion.
CONCLUSION


Ketamine appears to effectively treat both the typical/melancholic and atypical symptoms of depression, but may have early preferential effects for the former.",2020,"RESULTS


Scores improved significantly at Day 1 post-infusion (MADRS: Cohen's d=0.64; MADRS5:","['MDD participants were unmedicated; bipolar participants received', '68 participants with treatment-resistant major depressive disorder (MDD) or bipolar depression']","['therapeutic-dose lithium or valproate', 'ketamine', 'Ketamine', 'MADRS5', 'placebo']","['Typical and Atypical Depressive Symptoms', 'total MADRS, MADRS5, and SAS scores', 'general depressive symptoms', 'Montgomery-Asberg Depression Rating Scale (MADRS), typical/melancholic symptoms (measured using the MADRS5), and atypical symptoms (measured using the Scale for Atypical Symptoms (SAS']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",68.0,0.184973,"RESULTS


Scores improved significantly at Day 1 post-infusion (MADRS: Cohen's d=0.64; MADRS5:","[{'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Luckenbaugh', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Pennybaker', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Hopkins', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'Ioline D', 'Initials': 'ID', 'LastName': 'Henter', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Lener', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Ballard', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, Bethesda, MD, United States.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13216']
2872,32677106,"Safety and Efficacy of (+)-Epicatechin in Subjects with Friedreich's Ataxia: A Phase II, Open-Label, Prospective Study.","BACKGROUND


(+)-Epicatechin (EPI) induces mitochondrial biogenesis and antioxidant metabolism in muscle fibers and neurons. We aimed to evaluate safety and efficacy of (+)-EPI in pediatric subjects with Friedreich's Ataxia (FRDA).
METHODS


This was a Phase II, open-label, baseline-controlled single-center trial including ten participants ages 10-22 with confirmed FA diagnosis. (+)-EPI was administered orally at 75 mg/day for 24 weeks, with escalation to 150 mg/day at 12 weeks for subjects not showing improvement of neuromuscular, neurological or cardiac endpoints. Neurological endpoints were change from baseline in Friedreich's Ataxia Rating Scale (FARS) and 8-m timed walk. Cardiac endpoints were changes from baseline in left ventricular (LV) structure and function by cardiac MRI and echocardiogram, changes in cardiac electrophysiology, and changes in biomarkers for heart failure and hypertrophy.
RESULTS


Mean FARS/modified (m)FARS scores showed non-statistically significant improvement by both group and individual analysis. FARS/mFARS scores improved in 5/9 subjects (56%), 8-m walk in 3/9 (33%), 9-peg hole test in 6/10 (60%). LV mass index by cardiac MRI was significantly reduced at 12 weeks (P = 0.045), and was improved in 7/10 (70%) subjects at 24 weeks. Mean LV ejection fraction was increased at 24 weeks (P = 0.008) compared to baseline. Mean maximal septal thickness by echocardiography was increased at 24 weeks (P = 0.031). There were no serious adverse events.
CONCLUSION


(+)-EPI was well tolerated over 24 weeks at up to 150 mg/day. Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes. This article is protected by copyright. All rights reserved.",2020,Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes.,"[""pediatric subjects with Friedreich's Ataxia (FRDA"", ""Subjects with Friedreich's Ataxia"", 'ten participants ages 10-22 with confirmed FA diagnosis']","['Epicatechin', 'EPI']","['Mean FARS', 'LV mass index by cardiac MRI', 'Safety and Efficacy', ""Friedreich's Ataxia Rating Scale (FARS) and 8-m timed walk"", 'Mean maximal septal thickness by echocardiography', 'cardiac structure and function', 'left ventricular (LV) structure and function by cardiac MRI and echocardiogram, changes in cardiac electrophysiology, and changes in biomarkers for heart failure and hypertrophy', 'safety and efficacy', 'FARS/mFARS scores', 'Mean LV ejection fraction']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430467', 'cui_str': 'Cardiac electrophysiology'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]",10.0,0.0379406,Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes.,"[{'ForeName': 'M Yasir', 'Initials': 'MY', 'LastName': 'Qureshi', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Patterson', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Clark', 'Affiliation': 'Center for Individualized Medicine, Mayo Clinic, 200 First St SW, Rochester, Minnesota.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Johnson', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Moutvic', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sherilyn W', 'Initials': 'SW', 'LastName': 'Driscoll', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Rochester, Minnesota.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kemppainen', 'Affiliation': 'Department of Clinical Genomics, Mayo Clinic, 200 First St SW, Rochester, Minnesota, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Huston', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jeff R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Office of Translation to Practice, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Badley', 'Affiliation': 'Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Tebben', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wackel', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Oglesbee', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Rochester, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glockner', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Schreiner', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Dugar', 'Affiliation': 'Epirium Bio Inc., San Diego, California, USA.'}, {'ForeName': 'Jillienne C', 'Initials': 'JC', 'LastName': 'Touchette', 'Affiliation': 'Superior Medical Experts, St. Paul, Minnesota.'}, {'ForeName': 'Ralitza H', 'Initials': 'RH', 'LastName': 'Gavrilova', 'Affiliation': 'Department of Clinical Genomics, Mayo Clinic, 200 First St SW, Rochester, Minnesota, USA.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12285']
2873,32668588,A High-Protein Meal during a Night Shift Does Not Improve Postprandial Metabolic Response the Following Breakfast: A Randomized Crossover Study with Night Workers.,"The aim of this study was to compare the acute effect of a high-protein/moderate carbohydrate (HP-MCHO) versus low-protein/high-carbohydrate (LP-HCHO) meal served at night on the postprandial metabolic response of male night workers the following breakfast. A randomized crossover study was performed with 14 male night workers (40.9 ± 8.9 years old; 29.1 ± 5.3 kg/m 2 ). Participants underwent two different isocaloric dietary conditions at 1:00 h of the night shift: HP-MCHO (45 en% carbohydrate, 35 en% protein and 20 en% fat) and LP-HCHO (65 en% carbohydrate, 15 en% protein and 20 en% fat). Postprandial capillary glucose levels were determined immediately before the intake of the test meal and 30, 60, 90 and 120 min after the end of the meal. At the end of the work shift (6:30 h), participants received a standard breakfast and postprandial levels of glucose, insulin and triglycerides were determined immediately before and then every 30 min for 2 h (30, 60, 90 and 120 min). Higher values of capillary glucose were found after the LP-HCHO condition compared to the HP-MCHO condition (area under the curve (AUC) = 119.46 ± 1.49 mg/dL × min and 102.95 ± 1.28 mg/dL × min, respectively;  p  < 0.001). For the metabolic response to standard breakfast as the following meal, no significant differences in glucose, insulin, triglyceride, and HOMA-IR levels were found between interventions. A night meal with a higher percentage of protein and a lower percentage of carbohydrate led to minor postprandial glucose levels during the night shift but exerted no effect on the metabolic response of the following meal. This trial was registered at ClinicalTrials.gov as NCT03456219.",2020,"For the metabolic response to standard breakfast as the following meal, no significant differences in glucose, insulin, triglyceride, and HOMA-IR levels were found between interventions.","['male night workers the following breakfast', '14 male night workers (40.9 ± 8.9 years old; 29.1 ±', 'Night Workers']","['isocaloric dietary conditions at 1:00 h of the night shift: HP-MCHO (45 en% carbohydrate, 35 en% protein and 20 en% fat) and LP-HCHO', 'high-protein/moderate carbohydrate (HP-MCHO) versus low-protein/high-carbohydrate (LP-HCHO) meal']","['postprandial levels of glucose, insulin and triglycerides', 'metabolic response', 'Higher values of capillary glucose', 'glucose, insulin, triglyceride, and HOMA-IR levels', 'Postprandial Metabolic Response', 'Postprandial capillary glucose levels', 'postprandial metabolic response']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",,0.0117049,"For the metabolic response to standard breakfast as the following meal, no significant differences in glucose, insulin, triglyceride, and HOMA-IR levels were found between interventions.","[{'ForeName': 'Nayara B', 'Initials': 'NB', 'LastName': 'Cunha', 'Affiliation': 'Graduate Programme of Health Sciences, Faculty of Medicine, Federal University of Uberlândia, Av. Pará, 1720, Bloco 2U, Campus Umuarama, Uberlândia 38405-320, Minas Gerais, Brazil.'}, {'ForeName': 'Catarina M', 'Initials': 'CM', 'LastName': 'Silva', 'Affiliation': 'Graduate Programme of Health Sciences, Faculty of Medicine, Federal University of Uberlândia, Av. Pará, 1720, Bloco 2U, Campus Umuarama, Uberlândia 38405-320, Minas Gerais, Brazil.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Mota', 'Affiliation': 'Graduate Programme of Health Sciences, Faculty of Medicine, Federal University of Uberlândia, Av. Pará, 1720, Bloco 2U, Campus Umuarama, Uberlândia 38405-320, Minas Gerais, Brazil.'}, {'ForeName': 'Caio A', 'Initials': 'CA', 'LastName': 'Lima', 'Affiliation': 'Graduate Programme of Health Sciences, Faculty of Medicine, Federal University of Uberlândia, Av. Pará, 1720, Bloco 2U, Campus Umuarama, Uberlândia 38405-320, Minas Gerais, Brazil.'}, {'ForeName': 'Kely R C', 'Initials': 'KRC', 'LastName': 'Teixeira', 'Affiliation': 'Graduate Programme of Health Sciences, Faculty of Medicine, Federal University of Uberlândia, Av. Pará, 1720, Bloco 2U, Campus Umuarama, Uberlândia 38405-320, Minas Gerais, Brazil.'}, {'ForeName': 'Thulio M', 'Initials': 'TM', 'LastName': 'Cunha', 'Affiliation': 'Graduate Programme of Health Sciences, Faculty of Medicine, Federal University of Uberlândia, Av. Pará, 1720, Bloco 2U, Campus Umuarama, Uberlândia 38405-320, Minas Gerais, Brazil.'}, {'ForeName': 'Cibele A', 'Initials': 'CA', 'LastName': 'Crispim', 'Affiliation': 'Graduate Programme of Health Sciences, Faculty of Medicine, Federal University of Uberlândia, Av. Pará, 1720, Bloco 2U, Campus Umuarama, Uberlândia 38405-320, Minas Gerais, Brazil.'}]",Nutrients,['10.3390/nu12072071']
2874,32668834,Prevention of epidural catheter migration: A comparative evaluation of two tunneling techniques.,"Background


Epidural analgesia failure episodes can be reduced by catheter fixation technique with a lower incidence of catheter migration; in this clinical study we have compared the role of two epidural catheter tunneling techniques for the prevention of epidural catheter migration.
Methods


Patients undergoing major abdominal surgery were randomized into three groups of fifty each on the basis of method of securing epidural catheter. Control group (CG) where the epidural catheter was secured without tunneling; Tunneling group 1 (TG1) where tunneling was done along with a catheter loop; Tunneling group 2 (TG2) where tunneling was done without a catheter loop. Primary outcome measure was migration of epidural catheter; secondary outcome measures were adequacy of analgesia and signs of inflammation. All patients were followed up by the acute pain service team twice daily in the post-operative period till the epidural catheter was removed. Results were analyzed by the one-way ANOVA, Chi square test and Fisher's exact test. P value <0.05 was considered significant.
Results


The three groups were similar with respect to patient characteristics; Catheter migration was significantly reduced in the TG2 (3 patients) as compared to other 2 groups i.e. TG1 (8 patients) (P<0.05); and CG (16 patients) (P<0.05). There was no difference amongst the three groups as regards to adequacy of analgesia and catheter site inflammation (P>0.05).
Conclusions


Catheter migration was significantly reduced by tunneling without a catheter loop in TG2 as compared to other two groups.",2020,The three groups were similar with respect to patient characteristics; Catheter migration was significantly reduced in the TG2 (3 patients) as compared to other 2 groups i.e. TG1 (8 patients) (P<0.05); and CG (16 patients) (P<0.05).,['Patients undergoing major abdominal surgery'],"['epidural catheter was secured without tunneling; Tunneling group 1 (TG1) where tunneling was done along with a catheter loop; Tunneling group 2 (TG2) where tunneling was done without a catheter loop', 'epidural catheter migration', 'catheter fixation technique']","['adequacy of analgesia and catheter site inflammation', 'Conclusions\n\n\nCatheter migration', 'migration of epidural catheter', 'adequacy of analgesia and signs of inflammation', 'patient characteristics; Catheter migration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0948817', 'cui_str': 'Catheter site inflammation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0479062,The three groups were similar with respect to patient characteristics; Catheter migration was significantly reduced in the TG2 (3 patients) as compared to other 2 groups i.e. TG1 (8 patients) (P<0.05); and CG (16 patients) (P<0.05).,"[{'ForeName': 'Sujeet', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Additional Professor, Department of Aanesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, INDIA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Professor, Department of Aanesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, INDIA.'}, {'ForeName': 'Pravin Kumar', 'Initials': 'PK', 'LastName': 'Das', 'Affiliation': 'Additional Professor, Department of Aanesthesiology, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, INDIA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Khuba', 'Affiliation': 'Assistant Professor, Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, INDIA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Associate Professor, Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, INDIA.'}]",Korean journal of anesthesiology,['10.4097/kja.20131']
2875,32668874,[Feasibility and efficacy of partial superficial parotidectomy with V-shaped incision].,"Objective:  To evaluate the feasibility and efficacy of partial superficial parotidectomy with V-shaped incision by comparing with the Blair incision and hairline N-shaped incision.  Methods:  From January 2015 to January 2016, 60 patients (47 males and 13 females, with an age range of 25- 63 years) required for superficial partial parotid gland resection were randomly divided into three groups: V-shaped incision (VI) group, Blair incision (BI) group and hairline N-shaped incision (NI) group, with 20 cases in each group.Intraoperative, postoperative and follow-up indexes were compared between three groups. Operative time and drainage volume in the surgery of tumors at different sites in VI group were compared. SPSS18.0 software was used for statistic analysis.  Results:  There were no statistically significant differences among the three groups in operative time, drainage volume, postoperative hospital stay, periauricular numbness, fistulas, pain score, facial palsy, and scar score at the 3rd month after surgery ( P >0.05). For appearance satisfaction score at the 6th month after surgery, VI group was better than BI group or NI group, with significant differences(VI group  vs.  BI group: 9.00[8.00, 9.00]  vs.  5.00[4.00, 5.25], χ(2)=6.629,  P <0.001; VI group  vs.  NI group: 9.00[8.00, 9.00]  vs.  7.00[6.00, 8.00], χ(2)=2.942,  P =0.010; BI group  vs.  NI group: 5.00[4.00, 5.25]  vs.  7.00[6.00, 8.00], χ(2)=-3.687,  P =0.001). For tumors located in the front, upper and middle of parotid gland, there were no statistically significant differences in operative time and drainage volume between the three groups ( P >0.05). For tumors located at the lower part of parotid gland, the difference in operative time between the three groups was statistically significant ( F =7.278,  P =0.01). With pairwise comparison, operative time in VI group was longer than that in BI group or NI group, but there was no significant difference between BI group and NI group (VI group  vs.  BI group: (181.00±22.89) min  vs.  (132.50±9.01) min,  t =3.694,  P =0.004; VI group  vs.  NI group:(181.00±22.89) min  vs.  (149.00±15.94) min,  t =2.585,  P =0.025; BIgroup  vs.  NI group, (132.50±9.01) min  vs.  (149.00±15.94) min,  t =1.257,  P =0.235). For tumors located at the lower part of parotid gland, the differences in intraoperative drainage volume were not statistically significant between three groups ( P >0.05). There were no statistically significant differences in operative time and drainage volume in the surgery of tumors at different sites in VI group ( P >0.05).  Conclusions:  By use of V-shaped incision for the surgery of benign parotid gland tumors, the operation time of tumors located only in the lower part of the parotid gland will be prolonged. For tumors in different sites without increasing surgical complications, this modality can get good cosmetic effect.",2020,There were no statistically significant differences in operative time and drainage volume in the surgery of tumors at different sites in VI group ( P >0.05).  ,"['From January 2015 to January 2016, 60 patients (47 males and 13 females, with an age range of 25- 63 years) required for superficial partial parotid gland resection']","['partial superficial parotidectomy with V-shaped incision by comparing with the Blair incision and hairline N-shaped incision', 'V-shaped incision (VI) group, Blair incision (BI) group and hairline N-shaped incision (NI', 'V-shaped incision', 'partial superficial parotidectomy with V-shaped incision']","['operative time, drainage volume, postoperative hospital stay, periauricular numbness, fistulas, pain score, facial palsy, and scar score', 'Operative time and drainage volume', 'appearance satisfaction score', 'operative time', 'Intraoperative, postoperative and follow-up indexes', 'operative time and drainage volume', 'intraoperative drainage volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0554011', 'cui_str': 'Superficial parotidectomy'}, {'cui': 'C0439635', 'cui_str': 'V-shaped'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.019471,There were no statistically significant differences in operative time and drainage volume in the surgery of tumors at different sites in VI group ( P >0.05).  ,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, the Second Xiangya Hospital, Central South University, Changsha 410011, China.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, the Second Xiangya Hospital, Central South University, Changsha 410011, China.'}, {'ForeName': 'Q L', 'Initials': 'QL', 'LastName': 'Tang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, the Second Xiangya Hospital, Central South University, Changsha 410011, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Yang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, the Second Xiangya Hospital, Central South University, Changsha 410011, China.'}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'He', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, the Second Xiangya Hospital, Central South University, Changsha 410011, China.'}]",Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery,['10.3760/cma.j.cn115330-20191109-00678']
2876,32668990,Is Percutaneous Nephrolithotomy the Modality of Choice versus Shock Wave Lithotripsy for a 20-30 mm Single Renal Pelvic Stone with ≤1000 Hounsfield Unit in Adults? A Prospective Randomized Comparative Study.,"OBJECTIVES


To compare the efficacy, complications, and costs of percutaneous nephrolithotomy and shock wave lithotripsy in the treatment of a 20-30 mm single renal pelvic stone with a density ≤1000 Hounsfield unit.
PATIENTS AND METHODS


Eighty patients were prospectively randomized to receive either percutaneous nephrolithotomy or shock wave lithotripsy during May 2017-April 2019. The relevant demographic and clinical characteristics were compared.
RESULTS


The means of age in percutaneous nephrolithotomy and shock wave lithotripsy groups were 43.25±15.16 and 44.18±12.08 years, respectively. The means of stone sizes were 25.2±3.9 and 24.6±2.3 mm, respectively. The stone free rate was significantly different after the primary procedures (92.5% versus 37.5%, respectively; p <0.04), but it was comparable after three months (97.5% versus 90%, respectively; p=0.723) with a higher rate of auxiliary procedures after shock wave lithotripsy (p=0.017). On multivariate analysis, stone density was the only significant variable for stone free rate in shock wave lithotripsy group (p=0.004). Complications occurred in 27.5% and 22.5% of cases, respectively (p =0.796). The mean costs of shock wave lithotripsy (650.23 ± 424.74 US$) were significantly lower than those of percutaneous nephrolithotomy (1137.65 ± 224.43 US$; p <0.0001).
CONCLUSIONS


The stone free rates for percutaneous nephrolithotomy and shock wave lithotripsy were not significantly different after three months in the treatment of a 20-30 mm single renal pelvic stone with ≤1000 Hounsfield unit, although percutaneous nephrolithotomy provided a significantly higher rate after its primary procedure. Shock wave lithotripsy was significantly less costly, but it mandated a significantly higher number of auxiliary procedures than percutaneous nephrolithotomy.",2020,"The stone free rates for percutaneous nephrolithotomy and shock wave lithotripsy were not significantly different after three months in the treatment of a 20-30 mm single renal pelvic stone with ≤1000 Hounsfield unit, although percutaneous nephrolithotomy provided a significantly higher rate after its primary procedure.","['a 20-30 mm single renal pelvic stone with a density ≤1000 Hounsfield unit', 'Eighty patients']","['percutaneous nephrolithotomy', 'percutaneous nephrolithotomy and shock wave lithotripsy', 'Shock wave lithotripsy', 'percutaneous nephrolithotomy or shock wave lithotripsy', 'Percutaneous Nephrolithotomy the Modality of Choice versus Shock Wave Lithotripsy']","['efficacy, complications, and costs', 'stone sizes', 'mean costs of shock wave lithotripsy', 'Complications', 'stone free rate']","[{'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0227666', 'cui_str': 'Renal pelvis structure'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",80.0,0.0396091,"The stone free rates for percutaneous nephrolithotomy and shock wave lithotripsy were not significantly different after three months in the treatment of a 20-30 mm single renal pelvic stone with ≤1000 Hounsfield unit, although percutaneous nephrolithotomy provided a significantly higher rate after its primary procedure.","[{'ForeName': 'Rabea Ahmed', 'Initials': 'RA', 'LastName': 'Gadelkareem', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Urology, Assiut, Assiut, Egypt; dr.rabeagad@yahoo.com.'}, {'ForeName': 'Mohammed Abdelsalam', 'Initials': 'MA', 'LastName': 'Ibraheim', 'Affiliation': 'Armed Forces Medical Complex, Urology, Cairo, Cairo, Egypt; hemaabdo1977@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Reda', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Urology, Assiut, Assiut, Egypt; ahmedreda_leo@yahoo.com.'}, {'ForeName': 'Ahmed Shehata', 'Initials': 'AS', 'LastName': 'El-Azab', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Urology, Assiut, Assiut, Egypt; elazab@hotmail.com.'}, {'ForeName': 'Yaser Mahmoud', 'Initials': 'YM', 'LastName': 'Abdelsalam', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Urology, Assiut, Assiut, Egypt; yaser.71967@gmail.com.'}, {'ForeName': 'Mohamed Abdel-Basir', 'Initials': 'MA', 'LastName': 'Sayed', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Urology, Assiut, Egypt; sayedmohamed_22@hotmail.com.'}]",Journal of endourology,['10.1089/end.2020.0288']
2877,32669005,The effect of body position on maternal cardiovascular function during sleep and wakefulness in late pregnancy.,"INTRODUCTION


An association between the increased risk of late stillbirth and the maternal supine sleeping position has been recently established. The risk of stillbirth following supine sleep has been suspected to occur as a result of aortocaval compression by the gravid uterus. A number of studies conducted during wakefulness have reported compromised cardiovascular function during supine rest, as demonstrated by reductions in cardiac output, blood pressure and utero-placental blood flow. It remains unclear whether similar effects are also present during sleep, due to the presence of key sleep-specific changes in cardiovascular function.
OBJECTIVE


To investigate the changes in maternal cardiovascular function between the supine and left-lateral positions during wakefulness and non-rapid eye movement (NREM) sleep in late pregnancy.
METHODS


Twenty-nine women with a singleton pregnancy between 24.7 and 36.7 weeks' gestation participated in a single overnight sleep study. Physiological measures (blood pressure, heart rate, heart rate variability - HRV, and pulse arrival time - PAT) were measured and recorded throughout the night using standard polysomnography equipment and the Portapres Model-2 device. As the present study evaluated cardiovascular changes during natural rest and sleep in pregnancy, participants were not given explicit instructions on which position to adopt. Body position was continuously recorded using a position monitor and verified with video recording.
RESULTS


No changes in systolic, diastolic or mean arterial blood pressure were observed between the left-lateral and supine positions during wakefulness or sleep. However, heart rate was significantly higher in the supine position compared to the left during wakefulness ( p=  .03), with a similar trend present during sleep ( p = .11). A significantly shorter PAT was measured in the supine position (compared to the left) during wakefulness ( p=  .01) and sleep ( p=  .01). No change in HRV measures was observed between the left and supine positions in either state.
CONCLUSION


Blood pressure did not appear to differ significantly between the left-lateral and supine positions during wakefulness and sleep. The lack of blood pressure differences may reflect elevated sympathetic activity during rest and sleep in the supine position (compared to the left), suggesting that some degree of compensation for aortocaval compression may still be possible during sleep.",2020,"No changes in systolic, diastolic or mean arterial blood pressure were observed between the left-lateral and supine positions during wakefulness or sleep.","[""Twenty-nine women with a singleton pregnancy between 24.7 and 36.7 weeks' gestation participated in a single overnight sleep study"", 'late pregnancy']","['supine and left-lateral positions during wakefulness and non-rapid eye movement (NREM) sleep', 'body position']","['systolic, diastolic or mean arterial blood pressure', 'heart rate', 'Body position', 'Physiological measures (blood pressure, heart rate, heart rate variability - HRV, and pulse arrival time - PAT', 'Blood pressure', 'shorter PAT', 'maternal cardiovascular function', 'cardiac output, blood pressure and utero-placental blood flow', 'HRV measures']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0559227', 'cui_str': 'Left lateral decubitus position'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1262869', 'cui_str': 'Body position'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",29.0,0.0342875,"No changes in systolic, diastolic or mean arterial blood pressure were observed between the left-lateral and supine positions during wakefulness or sleep.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ishkova', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Wilson', 'Affiliation': 'Austin Health, Institute for Breathing and Sleep, Heidelberg, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Austin Health, Institute for Breathing and Sleep, Heidelberg, Australia.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Walker', 'Affiliation': 'Mercy Perinatal, Mercy Hospital for Women, Heidelberg, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Barnes', 'Affiliation': 'Austin Health, Institute for Breathing and Sleep, Heidelberg, Australia.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Nicholas', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jordan', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Parkville, Australia.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1789583']
2878,32669026,Arthroscopic Confirmation of Femoral Button Deployment Avoids Post Operative X-ray in ACL Reconstruction.,"BACKGROUND


Anterior cruciate ligament reconstruction (ACLR) with cortical fixation adjustable-loop devices are associated with high potential risk of button malpositioning or interposition of the soft tissue between lateral femoral cortex and the button. Surgeons usually use x-rays to check and avoid button malposition and soft tissue interposition. Arthroscopic visualization of button position through the lateral gutter has been described. With this technique it is possible the identification and correction of femoral button malalignment in the setting of soft tissue interposition and it could avoids the use of postoperative x-ray. Methods: A total of 193 ACLR were included and patients were randomized into two groups. The first series (Group A) of 112 patients who sustained an ACLR with post operative X-ray to assess the position of the femoral button and the second series (Group B) of 81 patients who sustained an ACLR with an arthroscopic exploration of the button followed by post operative X-ray. Results: On the post operative radiographs tissue interposition between the button and femoral cortex was found in 9 cases of 112 in the Group A (8%) and in 0 case of 81 in the Group B (0%) . In 6 cases (7,4%) in the Group B there was a soft tissue interposition between the button and femoral cortex as visualized by arthroscopic confirmation and before post operative X-ray; in all these cases the soft tissue was removed, and the button was in contact with the bone in all X-ray made in the group B. Conclusions: This technique could allows identification and correction of femoral button malalignment in the setting of soft tissue interposition and could reduce the use of postoperative x-ray. Level of evidence: Level III.",2020,"In 6 cases (7,4%) in the Group B there was a soft tissue interposition between the button and femoral cortex as visualized by arthroscopic confirmation and before post operative X-ray; in all these cases the soft tissue was removed, and the button was in contact with the bone in all X-ray made in the group B. Conclusions: This technique could allows identification and correction of femoral button malalignment in the setting of soft tissue interposition and could reduce the use of postoperative x-ray.","['A total of 193 ACLR', '112 patients who sustained an ACLR with post operative X-ray to assess the position of the femoral button and the second series (Group B) of 81 patients who sustained an ACLR with an arthroscopic exploration of the button followed by post operative X-ray']","['Arthroscopic Confirmation of Femoral Button Deployment Avoids Post Operative X-ray in ACL Reconstruction', 'Anterior cruciate ligament reconstruction (ACLR) with cortical fixation adjustable-loop devices']",['soft tissue interposition'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}]",193.0,0.0175416,"In 6 cases (7,4%) in the Group B there was a soft tissue interposition between the button and femoral cortex as visualized by arthroscopic confirmation and before post operative X-ray; in all these cases the soft tissue was removed, and the button was in contact with the bone in all X-ray made in the group B. Conclusions: This technique could allows identification and correction of femoral button malalignment in the setting of soft tissue interposition and could reduce the use of postoperative x-ray.","[{'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Matassi', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi , Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sani', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi , Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Innocenti', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi , Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Giabbani', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi , Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Civinini', 'Affiliation': 'Orthopaedic Clinic, University of Florence, AOU Careggi , Italy.'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1796469']
2879,32669052,"Comparison of Flywheel and Pneumatic Training on Hypertrophy, Strength, and Power in Professional Handball Players.","Purpose : The mechanical properties of resistance-training machines are a variable that may help to optimize sports performance and injury prevention protocols. The purpose of this study was to examine two non-gravity-dependent training modalities on muscle structure and function.  Methods : Eighteen professional handball players were randomly divided into two experimental groups: 1) iso-inertial flywheel training (FW) and 2) pneumatic resistance training (PN). Participants in both groups completed twelve training sessions in six weeks consisting of three movements (lateral raise, internal and external rotation). Four sets of seven repetitions for each movement were performed during each session. Before and after training subscapularis and deltoid (anterior, middle, posterior) muscle thickness was measured. Isokinetic torque and power during internal and external rotation at 60, 180, and 240 deg·s -1  was measured as well. Throwing speed was assessed before and after training while both sitting and standing situations.  Results : Both groups showed similar significant increases in throwing speed and internal and external rotation peak torque, average and peak power at all angular velocities. Anterior and middle deltoid muscle thickness changes were greater after training in FW (20 and 22%) in comparison to PN (14 and 7%, respectively).  Conclusions : In summary, both flywheel and pneumatic training resulted in similar increases in shoulder strength and power and throwing speed. However, flywheel training appeared to possibly result in a slightly greater level of muscle hypertrophy of the anterior and middle deltoid. Non-gravity dependent training appears to induce changes that would be beneficial to sports performance and perhaps injury prevention.",2020,"Both groups showed similar significant increases in throwing speed and internal and external rotation peak torque, average and peak power at all angular velocities.","['Professional Handball Players', 'Eighteen professional handball players']","['iso-inertial flywheel training (FW) and 2) pneumatic resistance training (PN', 'Flywheel and Pneumatic Training', 'flywheel training', 'flywheel and pneumatic training']","['shoulder strength and power and throwing speed', 'Anterior and middle deltoid muscle thickness changes', 'throwing speed and internal and external rotation peak torque, average and peak power at all angular velocities', 'Hypertrophy, Strength, and Power', 'Isokinetic torque and power during internal and external rotation']","[{'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",,0.0141908,"Both groups showed similar significant increases in throwing speed and internal and external rotation peak torque, average and peak power at all angular velocities.","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Maroto-Izquierdo', 'Affiliation': 'Universidad de León.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Appalachian State University.'}, {'ForeName': 'Nacho', 'Initials': 'N', 'LastName': 'Gonzalez-Diez', 'Affiliation': 'European University Miguel de Cervantes.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'García-López', 'Affiliation': 'European University Miguel de Cervantes.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'González-Gallego', 'Affiliation': 'Universidad de León.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'de Paz', 'Affiliation': 'Universidad de León.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1762836']
2880,32669099,Effectiveness of preemptive antifibrinolysis with tranexamic acid in rheumatoid arthritis patients undergoing total knee arthroplasty: a study protocol for a randomized controlled trial.,"BACKGROUND


Patients with rheumatoid arthritis (RA) who have undergone total knee arthroplasty are at increased risk of requiring a blood transfusion. This study is designed to compare the effects of preemptive antifibrinolysis of single-dose and repeat-dose tranexamic acid (TXA) in in RA patients undergoing total knee arthroplasty (TKA).
METHODS/DESIGN


The study will be a double-blind randomized controlled trial with two parallel groups of RA patients. Group A will be given 100 ml normal saline twice daily starting from 3 days before the operation, Group B will be given TXA 1.5 g twice daily starting from 3 days before the operation. All patients will be given TXA 1.5 g 30 min before the operation. The primary outcomes will be evaluated with total blood loss and hidden blood loss. Other outcome measurements such as, fibrinolysis parameters, inflammatory factors, visual analogue scale for post-operative pain, analgesia usage, coagulation parameters, transfusion, the length of stay (LOS), total hospitalization costs, the incidence of thromboembolic events and other complications will be recorded and compared. Recruitment is scheduled to begin on 1 August 2020, and the study will continue until 31 May 2021.
DISCUSSION


In current literature there is a lack of evidence with regard to the efficacy of TXA in RA patients. The findings of this study, whether positive or negative, will contribute to the formulation of further recommendations on the use of TXA in RA patients undergoing TKA.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR2000029720 . Registered 14 February 2020.",2020,"Other outcome measurements such as, fibrinolysis parameters, inflammatory factors, visual analogue scale for post-operative pain, analgesia usage, coagulation parameters, transfusion, the length of stay (LOS), total hospitalization costs, the incidence of thromboembolic events and other complications will be recorded and compared.","['RA patients undergoing total knee arthroplasty (TKA', 'RA patients undergoing TKA', 'two parallel groups of RA patients', 'rheumatoid arthritis patients undergoing total knee arthroplasty', 'Patients with rheumatoid arthritis (RA) who have undergone total knee arthroplasty']","['TXA', 'preemptive antifibrinolysis with tranexamic acid', 'preemptive antifibrinolysis of single-dose and repeat-dose tranexamic acid (TXA']","['fibrinolysis parameters, inflammatory factors, visual analogue scale for post-operative pain, analgesia usage, coagulation parameters, transfusion, the length of stay (LOS), total hospitalization costs, the incidence of thromboembolic events and other complications', 'total blood loss and hidden blood loss']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0151647', 'cui_str': 'Decreased fibrinolysis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.420225,"Other outcome measurements such as, fibrinolysis parameters, inflammatory factors, visual analogue scale for post-operative pain, analgesia usage, coagulation parameters, transfusion, the length of stay (LOS), total hospitalization costs, the incidence of thromboembolic events and other complications will be recorded and compared.","[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China. huangw511@163.com.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03488-8']
2881,32669111,Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (the SEcReT study): protocol for a randomised controlled pilot study.,"INTRODUCTION


Mild cognitive impairment is considered a precursor to dementia and significantly impacts upon quality of life. The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than in the general population, with older age and comorbidities further increasing the risk of cognitive decline. Exercise improves neurogenesis, synaptic plasticity and inflammatory and neurotrophic factor pathways, which may help to augment the effects of cognitive decline. However, the effects of resistance training on cognitive, functional and overall patient-reported recovery have not been investigated in the surgical cardiac population. This study aims to determine the effect of early moderate-intensity resistance training, compared to standard care, on cognitive recovery following cardiac surgery via a median sternotomy. The safety, feasibility and effect on functional recovery will also be examined.
METHODS


This study will be a prospective, pragmatic, pilot randomised controlled trial comparing a standard care group (low-intensity aerobic exercise) and a moderate-intensity resistance training group. Participants aged 18 years and older with coronary artery and/or valve disease requiring surgical intervention will be recruited pre-operatively and randomised 1:1 to either the resistance training or standard care group post-operatively. The primary outcome, cognitive function, will be assessed using the Alzheimer's Disease Assessment Scale and cognitive subscale. Secondary measures include safety, feasibility, muscular strength, physical function, multiple-domain quality of recovery, dynamic balance and patient satisfaction. Assessments will be conducted at baseline (pre-operatively) and post-operatively at 2 weeks, 8 weeks, 14 weeks and 6 months.
DISCUSSION


The results of this pilot study will be used to determine the feasibility of a future large-scale randomised controlled trial that promotes the integration of early resistance training into existing aerobic-based cardiac rehabilitation programs in Australia.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001430325p . Registered on 9 October 2017. Universal Trial Number (UTN): U1111-1203-2131.",2020,"The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than in the general population, with older age and comorbidities further increasing the risk of cognitive decline.","['Participants aged 18\u2009years and older with coronary artery and/or valve disease requiring surgical intervention will be recruited pre-operatively', 'Australia']","['early resistance training into existing aerobic-based cardiac rehabilitation programs', 'standard care group (low-intensity aerobic exercise', 'moderate-intensity resistance training group', 'resistance training or standard care group post-operatively', 'Supervised Early Resistance Training versus standard care', 'cardiac surgery via a median sternotomy', 'resistance training', 'early moderate-intensity resistance training', 'cardiac surgery via median sternotomy', 'ANZCTR']","['mild cognitive impairment', 'safety, feasibility, muscular strength, physical function, multiple-domain quality of recovery, dynamic balance and patient satisfaction', ""cognitive function, will be assessed using the Alzheimer's Disease Assessment Scale and cognitive subscale"", 'neurogenesis, synaptic plasticity and inflammatory and neurotrophic factor pathways']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0814002', 'cui_str': 'Neurogenesis'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}]",,0.15298,"The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than in the general population, with older age and comorbidities further increasing the risk of cognitive decline.","[{'ForeName': 'Jacqueline M S', 'Initials': 'JMS', 'LastName': 'Pengelly', 'Affiliation': 'Department of Nursing and Allied Health, Swinburne University of Technology, Hawthorn, Melbourne, Victoria, Australia. jpengelly@swin.edu.au.'}, {'ForeName': 'Alistair G', 'Initials': 'AG', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Bryant', 'Affiliation': 'Department of Physiotherapy, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Gavin P', 'Initials': 'GP', 'LastName': 'Williams', 'Affiliation': 'Department of Physiotherapy, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Lynda J', 'Initials': 'LJ', 'LastName': 'Tivendale', 'Affiliation': 'Department of Cardiothoracic Surgery, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Dettmann', 'Affiliation': 'Kieser Australia, South Melbourne, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Canty', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Colin F', 'Initials': 'CF', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Doa A', 'Initials': 'DA', 'LastName': 'El-Ansary', 'Affiliation': 'Department of Nursing and Allied Health, Swinburne University of Technology, Hawthorn, Melbourne, Victoria, Australia.'}]",Trials,['10.1186/s13063-020-04558-x']
2882,32674447,Topical Corticosteroids a Viable Solution for Oral Graft Versus Host Disease? A Systematic Insight on Randomized Clinical Trials.,"Background and Objectives:  This research attempts to provide a clear view of the literature on randomized clinical trials (RCTs) concerning the efficacy of topical dexamethasone, clobetasol and budesonide in oral graft versus host disease (GVHD).  Materials and Methods:  An electronic search of the PubMed, Web of Science and Scopus databases was carried out for eligible RCTs. Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English. The Cochrane Risk of Bias tool was used to assess the quality of these studies. Overall, three RCTs were included (an Open, Randomized, Multicenter Trial; a Randomized Double-Blind Clinical Trial; and an Open-Label Phase II Randomized Trial).  Results:  The trials involved 76 patients, of which 44 patients received topical dexamethasone, 14 patients received topical clobetasol and 18 patients received topical budesonide. Topical agents were most frequently used when oral tissues were the sole site of involvement. It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone. The limitation of the current study is mainly represented by the fact that overall response was derived in two of the studies from other parameters. Moreover, both budesonide and clobetasol were used in only one study each, while two assessed dexamethasone.  Conclusions:  Based on the clinical trials, all three agents seem to be effective in treating oral GVHD and had a satisfactory safety profile. There is still a need for assessing high quality RCTs to assess the efficacy of these therapies on a larger cohort.",2020,"It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone.","['76 patients, of which 44 patients received', 'Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English']","['topical clobetasol', 'dexamethasone', 'topical dexamethasone', 'Topical Corticosteroids', 'topical budesonide', 'topical dexamethasone, clobetasol and budesonide', 'budesonide']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]",[],76.0,0.24645,"It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone.","[{'ForeName': 'Arin', 'Initials': 'A', 'LastName': 'Sava', 'Affiliation': 'Department of Oral Rehabilitation, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Piciu', 'Affiliation': 'Department of Medical Oncology, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Sergiu', 'Initials': 'S', 'LastName': 'Pasca', 'Affiliation': 'Department of Hematology, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Mester', 'Affiliation': 'Department of Oral Health, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}, {'ForeName': 'Ciprian', 'Initials': 'C', 'LastName': 'Tomuleasa', 'Affiliation': 'Department of Hematology, University of Medicine and Pharmacy ""Iuliu Hatieganu"", 400012 Cluj-Napoca, Romania.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070349']
2883,32674461,Efficacy and Safety of the Combination of Pravastatin and Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (ESTAHEP Clinical Trial).,"Pravastatin has demonstrated anti-tumor activity in preclinical and clinical studies. This multicentric randomized double-blind placebo-controlled phase II study (NCT01418729) investigated the efficacy and safety of sorafenib + pravastatin combination on the overall survival (OS) and time to progression (TTP) of patients with advanced hepatocellular carcinoma (aHCC). A total of 31 patients were randomized. Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group). Of note, however, the radiological TTP was higher in patients treated with sorafenib + pravastatin than in the control group (9.9 months vs. 3.2 months;  p  = 0.008). Considering all the study population, the presence of portal vein thrombosis (PVT) was associated with worse OS, being lower in patients with PVT compared to patients without PVT (6.3 months vs. 14.8 months;  p  = 0.026). Data also showed a decrease in OS in patients with vascular invasion (VI) compared to patients who did not present it (6.3 months vs. 14.8 months;  p  = 0.041). The group of patients without dermatological events (DE) showed lower OS (6.9 months vs. 14.5 months;  p  = 0.049). In conclusion, combination of sorafenib + pravastatin was safe and well-tolerated, prolonging the TTP of patients with aHCC but not improving the OS compared to sorafenib + placebo. The absence of PVT and VI and the development of DE are positive prognostic factors of sorafenib response.",2020,Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group).,"['31 patients were randomized', 'patients with advanced hepatocellular carcinoma (aHCC']","['sorafenib + pravastatin combination', 'Pravastatin and Sorafenib', 'sorafenib + placebo', 'Pravastatin', 'sorafenib + pravastatin', 'placebo']","['Efficacy and Safety', 'Median OS', 'OS', 'radiological TTP', 'safe and well-tolerated', 'overall survival (OS) and time to progression (TTP', 'portal vein thrombosis (PVT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis'}]",31.0,0.0521069,Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group).,"[{'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Riaño', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Martín', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Varela', 'Affiliation': 'Digestive Service, Hepatology Unit, Asturias Central University Hospital, The University Institute of Oncology of Asturias (IUOPA), FINBA, 33006 Oviedo, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Serrano', 'Affiliation': 'Liver Unit, Lozano Blesa University Hospital-Aragon Health Research Institute, 50009 Zaragoza, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Núñez', 'Affiliation': 'Digestive Service, Infanta Sofía University Hospital, 28703 San Sebastián de los Reyes-Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mínguez', 'Affiliation': ""Liver Unit, Department of Medicine, Hospital Universitari Vall d'Hebron, Vall d´Hebron Institut of Research (VHIR), Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.""}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Perugorria', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Jesus M', 'Initials': 'JM', 'LastName': 'Banales', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}, {'ForeName': 'Juan I', 'Initials': 'JI', 'LastName': 'Arenas', 'Affiliation': 'Department of Liver and Gastrointestinal Diseases, Clinical Research Unit, Donostia University Hospital-Biodonostia Health Research Institute, 20014 San Sebastian, Spain.'}]",Cancers,['10.3390/cancers12071900']
2884,32674535,Changes in bench press performance and throwing velocity after strength-oriented and ballistic resistance training programs.,"BACKGROUND


This study aimed to compare the effect of two upper-body resistance training programs (strength-oriented vs. ballistic) on bench press (BP) performance and handball throwing velocity (HTV).
METHODS


Thirty resistance-trained males were randomly assigned to a strength-oriented training group (STG) or a ballistic training group (BTG). The study consisted of 11 sessions: 2 pre-tests (week 1), 8 training sessions (weeks 2-5), and 1 post-test (week 6). The STG performed the BP at the 70-90% of the one-repetition maximum (1RM), and the BTG the BP throw at the 40% of 1RM. BP performance (BP 1RM and maximum velocity achieved against 20 kg [BP20]) and HTV were assessed before and after training.
RESULTS


The STG enhanced BP 1RM (effect size [ES] = 0.24) but not BP20 (ES = 0.21) or HTV (ES = 0.10). The BTG enhanced BP20 (ES = 0.63) but not BP1RM (ES = 0.27) or HTV (ES = 0.02). HTV was not significantly correlated with the BP 1RM (r ≤ 0.181) or BP20 (r ≤0.220).
CONCLUSIONS


These results indicate that a short-term RT program based exclusively on the BP exercise performed against either heavy (strength-oriented) or light loads (ballistic) is not effective to increase HTV in resistance-trained men with little handball experience.",2020,The STG enhanced BP 1RM (effect size [ES] = 0.24) but not BP20 (ES = 0.21) or HTV (ES = 0.10).,['Thirty resistance-trained males'],"['two upper-body resistance training programs (strength-oriented vs. ballistic', 'strength-oriented training group (STG) or a ballistic training group (BTG', 'BP exercise performed against either heavy (strength-oriented) or light loads (ballistic']","['STG enhanced BP 1RM', 'BP performance (BP 1RM and maximum velocity achieved against 20 kg [BP20]) and HTV', 'bench press (BP) performance and handball throwing velocity (HTV', 'BP 1RM', 'HTV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]",,0.0261405,The STG enhanced BP 1RM (effect size [ES] = 0.24) but not BP20 (ES = 0.21) or HTV (ES = 0.10).,"[{'ForeName': 'Jesualdo', 'Initials': 'J', 'LastName': 'Cuevas-Aburto', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción, Concepción, Chile.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': 'The Research Centre, Faculty of Sport and Physical Education, University of Belgrade, Belgrade, Serbia - jan.danica@gmail.com.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Perez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Luis J', 'Initials': 'LJ', 'LastName': 'Chirosa-Ríos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción, Concepción, Chile.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11011-9']
2885,32674538,"The effect of high intensity functional training on the oxidative status, muscle damage and performance of basketball players.","BACKGROUND


The purpose of this study was to evaluate the effect of 10 weeks of two different in-season training programs on the oxidative status and muscle damage and performance of professional basketball players. We hypothesized that high intensity functional training (HIFT) induces more redox sensitive adaptations than common strength and conditioning training (CSCT).
METHODS


Twenty professional basketball players of Iran national women's basketball league (age=21.95±2.45, years of experience=7.15±1.7), were divided into two equal training groups; HIFT and CSCT (in average of 80-150 and 180-240 minutes per week respectively). Blood samples and performance tests including VO2max, basketball simulated performance (BEST), anaerobic power, agility and Vertical Jump were taken before and after training. Oxidative status and tissue damage were assessed through Xanthine Oxidase, Total Antioxidant Capacity, Pro oxidant/Antioxidant Balance and Creatine Kinase. Data were analyzed through repeated measure mixed ANOVA.
RESULTS


BEST, average power and fatigue index significantly improved in HIFT group (α<0.05). VO2max and agility T-test improved significantly in both groups (α<0.05), with no significant difference between the two groups. Lateral agility and Vertical Jump did not change significantly in neither of the groups. No significant group × time interaction was observed in the biochemical factors. XO increased, TAC and CK decreased significantly in both groups (α<0.05), with no significant change in PAB in neither of the groups after training.
CONCLUSIONS


The findings of the present study showed no oxidative stress and tissue damage in none of the training groups, recommending the implication of more time-efficient HIFT method into the in-season training of team sports.",2020,"XO increased, TAC and CK decreased significantly in both groups (α<0.05), with no significant change in PAB in neither of the groups after training.
","['professional basketball players', ""Twenty professional basketball players of Iran national women's basketball league (age=21.95±2.45, years of experience=7.15±1.7""]","['HIFT and CSCT', 'high intensity functional training (HIFT', 'high intensity functional training', 'season training programs']","['oxidative status, muscle damage and performance of basketball players', 'time interaction', 'TAC and CK', 'oxidative status and muscle damage and performance', 'Oxidative status and tissue damage', 'Xanthine Oxidase, Total Antioxidant Capacity, Pro oxidant/Antioxidant Balance and Creatine Kinase', 'BEST, average power and fatigue index', 'PAB', 'Blood samples and performance tests including VO2max, basketball simulated performance (BEST), anaerobic power, agility and Vertical Jump', 'oxidative stress and tissue damage', 'VO2max and agility T-test', 'Lateral agility and Vertical Jump']","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]",20.0,0.0202727,"XO increased, TAC and CK decreased significantly in both groups (α<0.05), with no significant change in PAB in neither of the groups after training.
","[{'ForeName': 'Ania', 'Initials': 'A', 'LastName': 'Hovsepian', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Esfarjani', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Efat', 'Initials': 'E', 'LastName': 'Bambaeichi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran - f.esfarjani@yahoo.com.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Zolaktaf', 'Affiliation': 'Department of Sport Injuries and Corrective Exercises, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11094-6']
2886,32674549,Beware of Early Relapse in Rectal Cancer Patients treated with Preoperative Chemoradiotherapy.,"PURPOSE


Recurrence pattern in rectal cancer patients treated with preoperative chemoradiotherapy (PCRT) are needed to evaluate for establishing tailored surveillance protocol.
METHODS


This study included 2215 patients with locally-advanced mid and low rectal cancer treated with radical resection between January 2005 and December 2012. Recurrence was evaluated according to receipt of PCRT; PCRT group (n=1258) and No PCRT group (n=957). Early recurrence occurred within 1 year of surgery and late recurrence after 3 years. The median follow-up duration was 65.7 ± 29 months.
RESULTS


The overall recurrence rate was similar between PCRT and No PCRT group (25.8% vs. 24.9%, p=0.622). The most common initial recurrence site was the lungs in both groups (50.6% vs. 49.6%, p=0.864), followed by the liver, which was more common in the No PCRT group (22.5% vs. 33.6%, p=0.004). Most of the recurrence occurred within 3 years after surgery in both groups (85.3% vs. 85.8%, p=0.862). Early recurrence was more common in the PCRT group than in the No PCRT group (43.1% vs. 32.4%, p=0.02). Recurrence within first 6 months after surgery was significantly higher in PCRT group (18.8% vs. 7.6%, p=0.003). Lung (n=27, 44.3%) and liver (n=22, 36.1%) were the frequent the first relapsed site within 6 month after surgery in PCRT group.
CONCLUSION


Early recurrence within first 1 year after surgery was more common in patients treated with PCRT. This difference would be considered for surveillance protocols and need to be evaluated in further studies.",2020,"Recurrence within first 6 months after surgery was significantly higher in PCRT group (18.8% vs. 7.6%, p=0.003).","['Rectal Cancer Patients treated with', 'rectal cancer patients treated with', '2215 patients with locally-advanced mid and low rectal cancer treated with radical resection between January 2005 and December 2012']","['Preoperative Chemoradiotherapy', 'PCRT', 'preoperative chemoradiotherapy (PCRT']","['Early recurrence', 'Recurrence', 'overall recurrence rate']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2215.0,0.0999037,"Recurrence within first 6 months after surgery was significantly higher in PCRT group (18.8% vs. 7.6%, p=0.003).","[{'ForeName': 'Seul-Gi', 'Initials': 'SG', 'LastName': 'Oh', 'Affiliation': 'Department of Surgery, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'In Ja', 'Initials': 'IJ', 'LastName': 'Park', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Division of Colorectal Surgery, Department of SurgeryCollege of Medicine and Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Young Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}, {'ForeName': 'Seok-Byung', 'Initials': 'SB', 'LastName': 'Lim', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}, {'ForeName': 'Chan Wook', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Yoon', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}, {'ForeName': 'Jong Lyul', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}, {'ForeName': 'Chang Sik', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}, {'ForeName': 'Jin Cheon', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center , Seoul, Korea.'}]",Annals of coloproctology,['10.3393/ac.2020.06.11']
2887,32674714,A Prescription for Wellness: Exercise Referrals at a Federally Qualified Health Center.,"Introduction/Objectives:  Physical activity (PA) improves quality of life and prevents chronic disease, but many adults are inactive. Planning with a health care provider in the form of an exercise ""prescription"" or referral may increase PA, but determinants of referral utilization are not well understood among underserved populations. This study examined sociodemographic and theory-based psychosocial determinants of exercise referral program utilization.  Methods:  Patients at a large, federally qualified health center with an on-site exercise facility (ie, ""Wellness Center"") referral were eligible to exercise with a personal fitness advisor. Self-reported PA behavior, self-efficacy, and self-regulation strategies were measured via survey and merged with electronic health records and attendance data. Negative binomial regression was used to estimate the rate of Wellness Center utilization.  Results:  Patients with exercise referrals (n = 1136) were, on average, 45.6 ± 14.6 years, 78.8% female, and 78.0% Hispanic/Latino or non-Hispanic Black. Approximately half (593/1136; 52.2%) initiated exercise at the Wellness Center; initiators completed 8.8 ± 12.4 visits during follow-up. Older age was associated with higher utilization ( P  < .001) and patients meeting PA recommendations had lower utilization than patients not meeting recommendations (incident rate ratio = 0.72, 95% CI 0.53-0.97;  P  = .03). Baseline self-efficacy ( P  < .001) and self-regulation strategies ( P  = .03) were significantly associated with follow-up PA, even after adjusting for baseline PA.  Conclusions:  In this racially/ethnically diverse patient population, older and less active patients at baseline had higher program utilization. Patients with higher self-efficacy and self-regulation strategies reported higher PA over time. Community health centers have a unique opportunity to support PA through exercise referral programs to public health priority populations.",2020,"Older age was associated with higher utilization ( P  < .001) and patients meeting PA recommendations had lower utilization than patients not meeting recommendations (incident rate ratio = 0.72, 95% CI 0.53-0.97;  P  = .03).","['were, on average, 45.6 ± 14.6 years, 78.8% female, and 78.0% Hispanic/Latino or non-Hispanic Black', 'Results:  Patients with exercise referrals (n = 1136', 'Methods:  Patients at a large, federally qualified health center with an on-site exercise facility (ie, ""Wellness Center', 'Wellness: Exercise Referrals at a Federally Qualified Health Center']",['Physical activity (PA'],"['quality of life and prevents chronic disease', 'Self-reported PA behavior, self-efficacy, and self-regulation strategies', 'Baseline self-efficacy', 'self-regulation strategies']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C5191065', 'cui_str': '1136'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0600622', 'cui_str': 'Wellness Centers'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",1136.0,0.0233475,"Older age was associated with higher utilization ( P  < .001) and patients meeting PA recommendations had lower utilization than patients not meeting recommendations (incident rate ratio = 0.72, 95% CI 0.53-0.97;  P  = .03).","[{'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Ylitalo', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Cox', 'Affiliation': 'Heart of Texas Community Health Center, Waco, TX, USA.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Gutierrez', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Benavidez', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'M Renée', 'Initials': 'MR', 'LastName': 'Umstattd Meyer', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Niceler', 'Affiliation': 'Heart of Texas Community Health Center, Waco, TX, USA.'}, {'ForeName': 'Jackson O', 'Initials': 'JO', 'LastName': 'Griggs', 'Affiliation': 'Heart of Texas Community Health Center, Waco, TX, USA.'}]",Journal of primary care & community health,['10.1177/2150132720942396']
2888,32674956,Effect of high-intensity training on peak oxygen uptake and muscular strength after lung transplantation: A randomized controlled trial.,"BACKGROUND


Peak oxygen uptake (VO 2peak ) remains low after lung transplantation (LTx). We evaluated the effect of high-intensity interval training (HIIT) on VO 2peak , muscular strength, health-related quality of life (HRQOL), pulmonary function, and physical function after LTx.
METHODS


In this randomized controlled trial, 54 participants were enrolled from 6 to 60 months after LTx. The HIIT group (n = 25) followed a supervised HIIT program, consisting of endurance and strength trainings 3 times a week for 20 weeks. The control group (n = 29) received usual care. The primary outcome was a change in VO 2peak  measured by cardiopulmonary exercise testing. The secondary outcomes were changes in 1-repetition maximum (1RM) for arm press and leg press, HRQOL (36-Item Short-Form Health Survey [SF-36]), pulmonary function (forced expiratory volume in 1 sec, diffusing capacity of the lungs for carbon monoxide), and physical function (1RM in handgrip, 15-sec stair run, and 30-sec chair stand).
RESULTS


A total of 46 participants completed the study, including 23 of 25 in the intervention group. For the primary outcome, the intention-to-treat analysis revealed a non-significant between-group difference for change in VO 2peak  of 0.7 ml/(kg.min) (95% CI = ‒0.3, 1.8) (p = 0.17). The between-group differences for 1RM arm press and leg press and mental aspect of SF-36 were 4.9 kg (95% CI = ‒0.1, 9.9) (p = 0.05), 11.6 kg (95% CI = 0.1, 23.0) (p < 0.05), and 5.7 kg (95% CI = 0.9, 10.4) (p = 0.02), respectively. There were no between-group differences in pulmonary function or physical function. When excluding participants with an attendance of <70% (n = 16), the between-group difference for VO 2peak  was 1.2 ml/(kg.min) (95% CI = 0.1, 2.4) (p = 0.032).
CONCLUSIONS


HIIT improved muscular strength and HRQOL but did not improve VO 2peak  more than usual care after LTx. However, with acceptable adherence, HIIT appears to have beneficial effects on VO 2peak .",2020,"For the primary outcome, the intention-to-treat analysis revealed a non-significant between-group difference for change in VO 2peak  of 0.7 ml/(kg.min)","['46 participants completed the study, including 23 of 25 in the intervention group', '54 participants were enrolled from 6 to 60 months after LTx', 'after lung transplantation']","['supervised HIIT program, consisting of endurance and strength trainings', 'usual care', 'high-intensity interval training (HIIT', 'high-intensity training']","['peak oxygen uptake and muscular strength', 'pulmonary function or physical function', 'VO 2peak , muscular strength, health-related quality of life (HRQOL), pulmonary function, and physical function after LTx', 'intention-to-treat analysis', 'change in VO 2peak  measured by cardiopulmonary exercise testing', '1RM arm press and leg press and mental aspect of SF-36', 'changes in 1-repetition maximum (1RM) for arm press and leg press, HRQOL (36-Item Short-Form Health Survey [SF-36]), pulmonary function (forced expiratory volume in 1 sec, diffusing capacity of the lungs for carbon monoxide), and physical function (1RM in handgrip, 15-sec stair run, and 30-sec chair stand', 'muscular strength and HRQOL']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1135599', 'cui_str': 'mental aspects'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",54.0,0.236441,"For the primary outcome, the intention-to-treat analysis revealed a non-significant between-group difference for change in VO 2peak  of 0.7 ml/(kg.min)","[{'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Ulvestad', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: mariannulv@gmail.com.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Durheim', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Johny S', 'Initials': 'JS', 'LastName': 'Kongerud', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'May B', 'Initials': 'MB', 'LastName': 'Lund', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Edvardsen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport and Sciences, Oslo, Norway; Department of Pulmonary Medicine, Oslo University Hospital Ullevål, Oslo, Norway.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.06.006']
2889,32675015,A Phase 2 Trial of Abiraterone Followed by Randomization to Addition of Dasatinib or Sunitinib in Men With Metastatic Castration-Resistant Prostate Cancer.,"BACKGROUND


Resistance to novel androgen signaling inhibition and metastatic castration-resistant prostate cancer (mCRPC) progression is likely dependent on tumor microenvironment interactions. The Src pathway and neoangiogenesis have been implicated in prostate cancer progression. We studied the effect of adding the targeted agents dasatinib and sunitinib to abiraterone acetate (AA) in men with mCRPC.
PATIENTS AND METHODS


In this open-label randomized phase 2 study, mCRPC patients received AA. At resistance to AA, they were randomized 1:1 to combination with dasatinib or sunitinib. At second progression, patients crossed over. The primary end point was time to treatment failure (TTF), defined as time to progression or death. Secondary end points included overall survival and safety.
RESULTS


From March 2011 to February 2015, a total of 179 patients were enrolled and 132 subsequently randomized. Median TTF was 5.7 months in the dasatinib group and 5.5 months in the sunitinib group. There was no difference between the two groups in terms of TTF (hazard ratio, 0.85; 95% confidence interval, 0.59-1.22). Median overall survival from study entry was 26.3 months in the dasatinib group and 27.7 months in the sunitinib group (hazard ratio, 1.02; 95% confidence interval, 0.71-1.47). Grade 3 or higher adverse events related to study medication were more frequent with sunitinib (n = 44, 46%) compared to dasatinib (n = 26, 24%). At data cutoff, 7 patients were experiencing a continuous response to AA, with a median duration of treatment of 5.7 years.
CONCLUSION


There is no difference in overall survival and TTF between dasatinib and sunitinib combined with abiraterone in the treatment of patients with bone mCRPC.",2020,There is no difference in overall survival and TTF between dasatinib and sunitinib combined with abiraterone in the treatment of patients with bone mCRPC.,"['Men', 'patients with bone mCRPC', 'With Metastatic Castration-Resistant Prostate Cancer', 'From March 2011 to February 2015, a total of 179 patients were enrolled and 132 subsequently randomized', 'men with mCRPC']","['Abiraterone', 'Dasatinib or Sunitinib', 'abiraterone acetate (AA', 'abiraterone', 'dasatinib or sunitinib']","['Median overall survival', 'Median TTF', 'time to treatment failure (TTF), defined as time to progression or death', 'overall survival and TTF', 'overall survival and safety']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517609', 'cui_str': '179'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",179.0,0.261779,There is no difference in overall survival and TTF between dasatinib and sunitinib combined with abiraterone in the treatment of patients with bone mCRPC.,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Spetsieris', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Boukovala', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Weldon', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Tsikkinis', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Hoang', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Aparicio', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Tu', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Amado J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Pagliaro', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jeri', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Subudhi', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Troncoso', 'Affiliation': 'Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics, West Virginia University School of Public Health, Morgantown, WV.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: eefstathiou@mdanderson.org.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2020.05.013']
2890,32675019,Traditional Brazilian diet and extra virgin olive oil reduce symptoms of anxiety and depression in individuals with severe obesity: Randomized clinical trial.,"RATIONAL & OBJECTIVE


Although the relationship between obesity, anxiety and depression is known, the clinical benefits of nutrition therapy in individuals with obesity have been scarcely studied. This study assessed the effectiveness of a traditional Brazilian diet (DieTBra) and extra virgin olive oil (EVOO) on the symptoms of anxiety and depression in severe obese participants.
METHOD


This was a parallel randomized clinical trial in adults with severe obesity (Body Mass Index - BMI ≥ 35 kg/m 2 ), DietBra Trial. Participants were randomized into three intervention groups in a ratio of 1: 1: 1 and followed up for 12 weeks. The three intervention groups were: 1) DieTBra, 2) 52 mL/day EVOO, and 3) DieTBra +52 mL/day EVOO. The symptoms of anxiety and depression were assessed by the Hospital Anxiety and Depression Scale. The outcome variables were: anxiety, depression and simultaneous anxiety and depression in the same individual.
RESULTS


149 severe obese individuals were randomized. The mean BMI was 46.3 ± 6.5 kg/m 2  with a mean age of 38.9 ± 8.7 years. After randomization, individuals on medication for depression and anxiety were excluded, totaling 129 at baseline, with 44:43:42 per group. At the end of 12 weeks 113 individuals completed the study. There was a significant reduction of symptoms for the three groups: EVOO, DieTBra and DieTBra + EVOO, respectively: anxiety 38.23% (p = 0.019), 45.83% (p=<0.014), 33.33% (p < 0.013) depression 55.17% (p=<0.001), 50.00% (p=<0.007), 34.61% (p=<0.035), and anxiety/depression 57.69% (p=<0.001), 66.67% (p=<0.014), 27.78% (p=<0.013).
CONCLUSIONS


Both DieTBra and olive oil interventions were effective in reducing symptoms of anxiety and depression in severe obese adults. These interventions can be integrated with clinical protocols for treatment of symptoms of anxiety and depression in severe obese individuals.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02463435.",2020,"There was a significant reduction of symptoms for the three groups: EVOO, DieTBra and DieTBra + EVOO, respectively: anxiety 38.23% (p = 0.019), 45.83% (p=<0.014), 33.33% (","['severe obese individuals', 'adults with severe obesity (Body Mass Index - BMI\xa0≥', 'individuals with obesity', '149 severe obese individuals', 'individuals with severe obesity', 'severe obese participants', 'severe obese adults']","['Traditional Brazilian diet and extra virgin olive oil', 'traditional Brazilian diet (DieTBra) and extra virgin olive oil (EVOO', 'Both DieTBra and olive oil interventions']","['symptoms of anxiety and depression', 'mean BMI', 'anxiety/depression', 'Hospital Anxiety and Depression Scale', 'anxiety and depression', 'anxiety, depression and simultaneous anxiety and depression in the same individual']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191071', 'cui_str': '149'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",149.0,0.0680091,"There was a significant reduction of symptoms for the three groups: EVOO, DieTBra and DieTBra + EVOO, respectively: anxiety 38.23% (p = 0.019), 45.83% (p=<0.014), 33.33% (","[{'ForeName': 'Andrea Batista de Sousa', 'Initials': 'ABS', 'LastName': 'Canheta', 'Affiliation': 'Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás (UFG), Brazil; Faculty of Education, Federal University of Goiás (UFG), Brazil.'}, {'ForeName': 'Annelisa Silva E Alves de Carvalho', 'Initials': 'ASEAC', 'LastName': 'Santos', 'Affiliation': 'United Faculty of Campinas (Unicamps/Goiás), Brazil; Faculty of Education, Federal University of Goiás (UFG), Brazil.'}, {'ForeName': 'Jacqueline Danésio de', 'Initials': 'JD', 'LastName': 'Souza', 'Affiliation': 'Course of Nutrition, University of North Paraná (UNOPAR - Londrina/PR), Brazil; Faculty of Education, Federal University of Goiás (UFG), Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'Silveira', 'Affiliation': 'Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás (UFG), Brazil. Electronic address: erikasil@terra.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.046']
2891,32677298,Exploring the occurrence of sudden gains among anxious youth receiving evidence-based cognitive-behavioral therapy.,"BACKGROUND


There is limited information on the occurrence of 'sudden gains' - recognized improvements of substantial magnitude occurring between individual sessions of treatment. This study explores changes in anxiety across sessions of CBT for youth anxiety disorders to determine whether evidence exists for sudden gains in this population.
METHOD


A total of 133 anxious youth (M age   = 10.16 years; 55.6% male) were randomly assigned to receive 16 sessions of individual cognitive-behavioral therapy (ICBT), family-based CBT (FCBT), or a family-based educational support and attention control (FESA). At each treatment session, youth completed a measure of anxiety. Sudden gains were calculated from weekly state anxiety scores using methods consistent with previous research (i.e., Tang & DeRubeis, 1999).
RESULTS


Three participants experienced a sudden gain at any point during treatment; all experienced a reversal of the sudden gain, although one experienced a regain of the improvement that occurred during the sudden gain.
CONCLUSIONS


While sudden gains have been demonstrated in some studies, in a relatively new topic to the literature such as this, it should also be considered that many evidence-based treatments are actually intended to produce more steady/gradual gains - which may be particularly true for youth who are not as cognitively advanced as adults and who have much to learn about how psychopathology - and for this analysis, anxiety - operates.",2018,"This study explores changes in anxiety across sessions of CBT for youth anxiety disorders to determine whether evidence exists for sudden gains in this population.
","['anxious youth receiving evidence-based cognitive-behavioral therapy', '133 anxious youth (M age  \xa0=\xa010.16\xa0years; 55.6% male', 'youth anxiety disorders']","['CBT', 'individual cognitive-behavioral therapy (ICBT), family-based CBT (FCBT), or a family-based educational support and attention control (FESA']","['Sudden gains', 'sudden gain']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517518', 'cui_str': '10.16'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1276802', 'cui_str': 'Sudden'}]",133.0,0.0272532,"This study explores changes in anxiety across sessions of CBT for youth anxiety disorders to determine whether evidence exists for sudden gains in this population.
","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Mychailyszyn', 'Affiliation': 'Towson University, Baltimore, MD, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Carper', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Gibby', 'Affiliation': 'Florida State University Ringgold Standard Institution, Tallahassee, FL, USA.'}]",Child and adolescent mental health,['10.1111/camh.12254']
2892,32677331,Innovations in practice: group mindfulness for adolescent anxiety - results of an open trial.,"BACKGROUND


Group Mindfulness Therapy (GMT) is a program tailored for adolescents that targets anxiety with mindfulness skills including present moment awareness, mindfulness in everyday life (breathing, eating, walking), body scan, loving-kindness, and self-acceptance. Youth with anxiety may benefit from mindfulness exercises precisely because they learn to redirect their mind, and presumably their attention, away from wandering in the direction of worry and negative self-appraisals and toward greater acceptance of internal states. This open trial assessed the feasibility and initial effectiveness of GMT in a school setting.
METHOD


Twelve 6th and 7th grade adolescents with elevated anxiety [Screen for Child Anxiety Disorders (SCARED) ≥ 30] participated in GMT after school. Youth completed measures of anxiety and perceived stress and their parents completed measures of internalizing and externalizing behavior problems at pretreatment and posttreatment. We hypothesized that GMT would significantly reduce youth anxiety and stress.
RESULTS


Significant improvements were observed in anxiety, internalizing, stress, and attention, with effect sizes ranging from .88 to 1.34.
CONCLUSIONS


We demonstrate that GMT is feasible and acceptable to adolescents presenting with anxiety as a primary concern. We provide further support for the use of a mindfulness-based intervention for anxiety reduction. The group format suggests a cost-effective way to deliver services in a school setting.",2018,"RESULTS


Significant improvements were observed in anxiety, internalizing, stress, and attention, with effect sizes ranging from .88 to 1.34.
","['≥\xa030', 'Child Anxiety Disorders (SCARED', 'Twelve 6th and 7th grade adolescents with elevated anxiety', 'Youth with anxiety']","['Group Mindfulness Therapy (GMT', 'GMT']","['anxiety and perceived stress and their parents completed measures of internalizing and externalizing behavior problems', 'youth anxiety and stress', 'anxiety, internalizing, stress, and attention, with effect sizes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",30.0,0.0248052,"RESULTS


Significant improvements were observed in anxiety, internalizing, stress, and attention, with effect sizes ranging from .88 to 1.34.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Nicholls', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Division of Occupational Therapy, American International College, Springfield, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Greatorex', 'Affiliation': 'Regional Andover, Hebron, Marlborough (RHAM) Middle School, Hebron, CT, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Mayes', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, USA.'}]",Child and adolescent mental health,['10.1111/camh.12214']
2893,32677336,Parental and child factors associated with participation in a randomised control trial of an Internet-assisted parent training programme.,"BACKGROUND


Parental training is an effective way to treat and prevent children's conduct problems, but knowledge of who participates in such initiatives is limited.
METHOD


This study examined child and family factors associated with participation in an Internet-assisted parent training programme. The parents of 4-year-old children with high levels of disruptive behaviour in a region of Finland were offered the opportunity to participate in a randomised controlled trial of the Strongest Families Smart Website intervention (SFSW). The participants and nonparticipants were compared using the Strengths and Difficulties Questionnaire (SDQ), duration of child problems and information about family demographics, which were routinely collected prior to randomisation to the SFSW and control group.
RESULTS


We found that 464 (64.5%) of the 709 parents of children fulfilling the screening criteria, participated. In the multivariable analysis, nonparticipation was most strongly associated with a child only having minor difficulties [odds ratio (OR): 2.1; 95% confidence interval (CI): 1.5-3.0] and a shorter duration of problems, for less than 12 months (OR: 1.7, 95% CI: 1.2-2.5), after controlling for other child factors. Nonparticipation was significantly associated with mothers spending a shorter time in the education system (OR: 1.6, 95% CI: 1.2-2.3) after controlling for other parental factors.
CONCLUSIONS


A larger percentage of parents of children with longer lasting and more severe problems seemed to be motivated to participate in this remote parent training programme. Future studies on how to encourage parents with shorter duration of education to participate in early intervention programmes are warranted.",2018,"Nonparticipation was significantly associated with mothers spending a shorter time in the education system (OR: 1.6, 95% CI: 1.2-2.3) after controlling for other parental factors.
","['464 (64.5%) of the 709 parents of children fulfilling the screening criteria, participated', 'parents of 4-year-old children with high levels of disruptive behaviour in a region of Finland']","['Internet-assisted parent training programme', 'Strongest Families Smart Website intervention (SFSW']","['Strengths and Difficulties Questionnaire (SDQ), duration of child problems and information about family demographics']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0543091,"Nonparticipation was significantly associated with mothers spending a shorter time in the education system (OR: 1.6, 95% CI: 1.2-2.3) after controlling for other parental factors.
","[{'ForeName': 'Sturla', 'Initials': 'S', 'LastName': 'Fossum', 'Affiliation': 'UiT The Artic University of Norway, Faculty of Health Sciences, The Regional Centre for Child and Youth Mental Health and Child Welfare - North, Tromsø, Norway.'}, {'ForeName': 'Terja', 'Initials': 'T', 'LastName': 'Ristkari', 'Affiliation': 'Department of Child Psychiatry, Clinical Sciences, Medical Faculty, University of Turku and Turku University Hospital, Lemminkäisenkatu 3/ Teutori 3. krs, 20014, Turku, Finland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cunningham', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, Faculty of Health Science, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Centre for Research in Family Health, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Auli', 'Initials': 'A', 'LastName': 'Suominen', 'Affiliation': 'Department of Child Psychiatry, Clinical Sciences, Medical Faculty, University of Turku and Turku University Hospital, Lemminkäisenkatu 3/ Teutori 3. krs, 20014, Turku, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Huttunen', 'Affiliation': 'Department of Child Psychiatry, Clinical Sciences, Medical Faculty, University of Turku and Turku University Hospital, Lemminkäisenkatu 3/ Teutori 3. krs, 20014, Turku, Finland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lingley-Pottie', 'Affiliation': 'Centre for Research in Family Health, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Sourander', 'Affiliation': 'Department of Child Psychiatry, Clinical Sciences, Medical Faculty, University of Turku and Turku University Hospital, Lemminkäisenkatu 3/ Teutori 3. krs, 20014, Turku, Finland.'}]",Child and adolescent mental health,['10.1111/camh.12193']
2894,32677346,Innovations in Practice: Intensive crisis intervention for adolescent suicidal ideation and behavior - an open trial.,"BACKGROUND


Adolescent suicide is a major public health concern worldwide. However, evidence regarding the effectiveness of interventions targeting youth suicide risk is limited. The purpose of this study was to assess the feasibility, acceptability, and clinical outcomes of Intensive Crisis Intervention (ICI), a cognitive-behavioral, family-centered treatment that provides an alternative to longer inpatient care.
METHOD


Intensive Crisis Intervention was piloted over a two-year period with 50 adolescents (M age   = 15.1 years; 86% Female; 78% Caucasian) admitted to an intensive crisis stabilization unit presenting with suicidal ideation and/or attempts. Data were collected at admission, 30 days, and 3 months post-admission to evaluate changes in suicidal ideation and functioning over time.
RESULTS


Follow-up data were provided by 88% of study participants. At 3 months, the mean Suicidal Ideation Questionnaire-Junior score improved 34.2 points relative to baseline (effect size of 2.2, p < .0001). Significant improvements in functioning, high rates of consumer satisfaction and readiness for care transition upon discharge were also reported.
CONCLUSION


Study findings set the stage for a larger, randomized controlled trial to examine the efficacy of ICI in targeting suicidal ideation and behavior in adolescents.",2019,"At 3 months, the mean Suicidal Ideation Questionnaire-Junior score improved 34.2 points relative to baseline (effect size of 2.2, p < .0001).","['adolescents', 'Intensive Crisis Intervention was piloted over a two-year period with 50 adolescents (M age  \xa0=\xa015.1\xa0years; 86% Female; 78% Caucasian) admitted to an intensive crisis stabilization unit presenting with suicidal ideation and/or attempts']","['Intensive Crisis Intervention (ICI', 'ICI']","['functioning, high rates of consumer satisfaction and readiness for care transition upon discharge', 'mean Suicidal Ideation Questionnaire-Junior score', 'suicidal ideation and functioning over time']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010332', 'cui_str': 'Crisis intervention'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0010332', 'cui_str': 'Crisis intervention'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009827', 'cui_str': 'Consumer Satisfaction'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.129166,"At 3 months, the mean Suicidal Ideation Questionnaire-Junior score improved 34.2 points relative to baseline (effect size of 2.2, p < .0001).","[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'McBee-Strayer', 'Affiliation': ""The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Glenn V', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': ""Nationwide Children's Hospital Big Lots Behavioral Health Services, Columbus, OH, USA.""}, {'ForeName': 'Ericka M', 'Initials': 'EM', 'LastName': 'Bruns', 'Affiliation': ""Nationwide Children's Hospital Big Lots Behavioral Health Services, Columbus, OH, USA.""}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Heck', 'Affiliation': ""The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Alexy', 'Affiliation': ""The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bridge', 'Affiliation': ""The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}]",Child and adolescent mental health,['10.1111/camh.12340']
2895,32677455,Effects of Relaxation-Focused Nursing Care in Women in Preterm Labor.,"BACKGROUND


Threatened preterm labor is a common problem that causes women to be hospitalized. During this period, physical problems such as a decrease in muscle functions, edema and pain, and psychological problems such as anxiety and stress may develop.
OBJECTIVE


This study aimed to investigate the effect of relaxation-focused nursing care state anxiety, cortisol, contraction severity, nursing care satisfaction, knowledge, and birth weeks on threatened preterm labor.
METHOD


This study was a pre-post single-blind randomized controlled trial. The study was conducted with 66 women in the threatened preterm labor process, 33 in the intervention group and 33 in the control group. The intervention group received relaxation-focused nursing care, which comprises a 2-day program in four stages. The data were collected before and after the relaxation-focused nursing care, and after the birth.
RESULTS


In the intervention group, state anxiety, cortisol level, and contraction severity were lower than those in the control group ( p  < .05). The knowledge level about threatened preterm labor, satisfaction from nursing care, and birth weeks were higher in the intervention group ( p  < .05).
CONCLUSION


Relaxation-focused nursing care was found to reduce the state anxiety in women, improve the knowledge level about threatened preterm labor and birth weeks, and decrease the level of cortisol. Therefore, it is recommended to use relaxation-focused nursing care in threatened preterm labor.",2020,"In the intervention group, state anxiety, cortisol level, and contraction severity were lower than those in the control group ( p  < .05).","['Women in Preterm Labor', '66 women in the threatened preterm labor process, 33 in the intervention group and 33 in the control group']","['relaxation-focused nursing care', 'Relaxation-Focused Nursing Care', 'Relaxation-focused nursing care']","['level of cortisol', 'state anxiety, cortisol level, and contraction severity', 'muscle functions, edema and pain, and psychological problems', 'state anxiety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",66.0,0.0421801,"In the intervention group, state anxiety, cortisol level, and contraction severity were lower than those in the control group ( p  < .05).","[{'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Özberk', 'Affiliation': 'Nursing Faculty, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Samiye', 'Initials': 'S', 'LastName': 'Mete', 'Affiliation': 'Retired, Department of Obstetrics and Gynecology Nursing, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bektaş', 'Affiliation': 'Nursing Faculty, Dokuz Eylul University, Izmir, Turkey.'}]",Biological research for nursing,['10.1177/1099800420941253']
2896,32677458,A single educational intervention on heart failure self-care: Extended follow-up from a multisite randomized controlled trial.,"BACKGROUND


Heart failure outcomes remain poor, and little is known about the causes and predictors of these outcomes in Lebanon.
AIM


The purpose of this article is to report the causes and predictors of the 6- and 12-month readmission and mortality of previously recruited patients to the Family focused Approach to iMprove Heart Failure care In LebanonQualitY intervention (FAMILY) study.
METHODS


A multi-site block randomized controlled trial in three tertiary medical centers in Beirut. Initially, participants were randomized to either the control or the intervention group. The latter group, with their family caregivers, received heart failure self-care resources and an educational intervention on self-care and symptom management during their index admission. Participants from the FAMILY study were followed up with through phone calls for readmission and mortality at 6 and 12 months following their hospital discharge.
RESULTS


A total of 218 (85%) patients were followed up with for this evaluation. There was a significant difference between the intervention group and the control group in terms of mortality at 6 months ( n =18 (16%) versus  n =36 (33%);  p <0.05) and 12 months ( n =29 (26%) versus  n =45 (42%);  p <0.05) post the index discharge. Mortality at 6 and 12 months was associated with aging, lower body mass index scores and readmission at 30 days post the index admission. Results of a logistic regression for mortality at 6 months showed hypertensive etiology of heart failure and 30-day readmission to be the only significant predictors.
CONCLUSION


A single session intervention was associated with lower mortality, even after an extended period of time, possibly mediated by other variables. Future studies should be powered for such outcomes while also addressing the cultural needs and literacy levels of the patients using multi-session trials and more frequent follow-ups.",2020,"Mortality at 6 and 12 months was associated with aging, lower body mass index scores and readmission at 30 days post the index admission.","['previously recruited patients to the Family focused Approach to iMprove Heart Failure care', 'A multi-site block randomized controlled trial in three tertiary medical centers in Beirut']","['heart failure self-care resources and an educational intervention', 'educational intervention']","['mortality', 'heart failure self-care', 'Mortality', 'hypertensive etiology of heart failure and 30-day readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",,0.0811995,"Mortality at 6 and 12 months was associated with aging, lower body mass index scores and readmission at 30 days post the index admission.","[{'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Deek', 'Affiliation': 'Faculty of Health Sciences, Beirut Arab University, Lebanon.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Noureddine', 'Affiliation': 'Rafic Hariri School of Nursing, American University of Beirut, Lebanon.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Allam', 'Affiliation': 'Cardiac Care Unit, Rafic Hariri University Hospital, Lebanon.'}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Newton', 'Affiliation': 'Western Sydney Nursing and Midwifery Research Centre, Western Sydney University and Western Sydney Local District, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Davidson', 'Affiliation': 'Johns Hopkins School of Nursing, USA.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515120941645']
2897,32677483,The Effect of Antenatal Steroid Therapy on Early Inflammation Markers and Leukocyte Counts in Premature Infants.,"OBJECTIVE


We investigated the effect of antenatal steroid therapy(AST) on white blood cell (WBC) and neutrophil counts and the inflammatory markers C-reactive protein(CRP), interleukin 6(IL-6), interleukin 10(IL-10), and beta-2 microglobulin(ß2M) in preterm infants.  Materials Method:  Neonates born at ≤34 weeks of gestation and admitted at hospital between May and November 2018 were included. The neonates were divided into three groups based on AST dose administered: 24 mg betamethasone (full course), 12 mg betamethasone (incomplete course), and no AST. 170 infants were analyzed.
RESULTS


Of these, 45.2% (n = 77) received a full course of AST, 38.8% (n = 66) received an incomplete course of AST, and 15.8% (n = 27) did not receive AST. WBC, CRP, IL-6, IL-10, and ß2M levels were similar between the three groups, whereas neutrophil count was significantly lower in full course AST group.
CONCLUSION


Consistent with the literature data, AST was associated with reduced neutrophil count but did not affect the other inflammatory markers studied.",2020,"WBC, CRP, IL-6, IL-10, and ß2M levels were similar between the three groups, whereas neutrophil count was significantly lower in full course AST group.
","['170 infants were analyzed', 'Premature Infants', 'Neonates born at ≤34\u2009weeks of gestation and admitted at hospital between May and November 2018 were included', 'preterm infants']","['betamethasone', 'antenatal steroid therapy(AST', 'betamethasone (incomplete course), and no AST', 'Antenatal Steroid Therapy']","['neutrophil count', 'white blood cell (WBC) and neutrophil counts and the inflammatory markers C-reactive protein(CRP), interleukin 6(IL-6), interleukin 10(IL-10), and beta-2 microglobulin(ß2M', 'Early Inflammation Markers and Leukocyte Counts', 'WBC, CRP, IL-6, IL-10, and ß2M levels']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",170.0,0.0391193,"WBC, CRP, IL-6, IL-10, and ß2M levels were similar between the three groups, whereas neutrophil count was significantly lower in full course AST group.
","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Beser Ozmen', 'Affiliation': 'Department of Neonatology, NICU, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Kadioglu Simsek', 'Affiliation': 'Department of Neonatology, NICU, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Ceran', 'Affiliation': 'Department of Neonatology, NICU, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Fuat Emre', 'Initials': 'FE', 'LastName': 'Canpolat', 'Affiliation': 'Department of Neonatology, NICU, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'H Gozde', 'Initials': 'HG', 'LastName': 'Kanmaz Kutman', 'Affiliation': 'Department of Neonatology, NICU, Ankara City Hospital, Ankara, Turkey.'}]",Fetal and pediatric pathology,['10.1080/15513815.2020.1792014']
2898,32674613,Immediate effect of neuromuscular electrical stimulation on the abductor hallucis muscle: A randomized controlled trial.,"Hallux valgus (HV) is a foot deformity with deviation of the greater toe and the first metatarsal. There is little evidence on training the abductor hallucis muscle (AbdH) to treat HV because of the difficulty in implementing the necessary interventions. Although neuromuscular electrical stimulation (NMES) has been used to induce voluntary exercise, there is currently no study on NMES for AbdH. We aimed to verify the immediate effect of NMES on the AbdH muscle function. For the NMES group (n = 15), electrical stimulation was applied for 20 min. In the sham group (n = 15), the stimulating device was set but not turned on. Electromyogram, HV angle (HVA) at rest and during abduction of the big toe, and strength of the AbdH were evaluated. Analysis of covariance was used to investigate differences within groups using the baseline as the covariate. NMES significantly improved the maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC:  p  = .00, HVA exercise:  p  = .00, AbdH strength:  p  = .00). HVA at rest showed no change ( p  = .12). Application of NMES on the AbdH muscle immediately improved its activity output, muscle strength, and HVA during exercise.",2020,"NMES significantly improved the maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC:  ",['abductor hallucis muscle'],"['NMES', 'neuromuscular electrical stimulation (NMES', 'HVA exercise', 'neuromuscular electrical stimulation']","['activity output, muscle strength, and HVA', 'maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC', 'Electromyogram, HV angle (HVA) at rest and during abduction of the big toe, and strength of the AbdH']","[{'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0018534', 'cui_str': 'Hallux structure'}, {'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}]",,0.0262283,"NMES significantly improved the maximal voluntary isometric contractions (%MVIC), HVA at exercise, and muscle strength (%MVIC:  ","[{'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Shimoura', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Abiko', 'Affiliation': 'Science Department, Ito Co., Ltd ., Saitama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Zeidan', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kajiwara', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Bito', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Soyoka', 'Initials': 'S', 'LastName': 'Yoshimi', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Kawabe', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University , Kyoto, Japan.'}]",Electromagnetic biology and medicine,['10.1080/15368378.2020.1793166']
2899,32674651,A randomized controlled study examining a novel binaural beat technique for treatment of preoperative anxiety in a group of women undergoing elective caesarean section.,"IMPORTANCE


Attention is being focused on improving mothers' positive experiences of childbirth while reducing the negative ones. Cesarean section is a known factor able to increase maternal anxiety.
OBJECTIVE


To determine whether a new binaural beat-based technique can reduce the preoperative discomfort of the elective surgical patient.
METHODS


Prospective, randomized double-blind controlled study: 60 women scheduled to undergo elective cesarean section. Women with a low risk pregnancy were recruited and enrolled at the time of the ""37 weeks"" visit. Exclusion criteria were: psychiatric disorders, neurological impairment, epilepsy, deafness, use of drugs/alcohol during pregnancy, insufficient reading level. Participants will be contestually allocated to one of three groups according to a predetermined computer-generated random sequence: (1) ""binaural"" group, (2) ""normal music"" group, and (3) ""control"" group. Participants of groups 1 and 2 will be unaware of the type of audio heard.
INTERVENTION


According to the allocation arm, participants were asked to listen an engineered audio track (binaural beat arm) created with the novel algorithm ""Dynamic Spectrum Phase Shift"" (DMSPS), or an identical soundtrack without DMSPS in it (music arm), or no specific intervention, representing standard practice. The feeling of anxiety has been measured by the State-Trait Anxiety Inventory (STAI-Y) questionnaire.  Conclusions and Relevance:  Binaural beat audio created with DMSPS algorithm provides superior changes in reported anxiety in comparison to normal music and above all to standard care. This technique does not need extra staff or extra staying time for the patients, so it could be a cost-effective way to manage preoperative anxiety in women undergoing elective cesarean section, with a potential impact to the mother's positive experiences and care of the newborn.  The EudraCT number:  2019-000743-27.",2020,Binaural beat audio created with DMSPS algorithm provides superior changes in reported anxiety in comparison to normal music and above all to standard care.,"['Women with a low risk pregnancy', '60 women scheduled to undergo elective cesarean section', 'women undergoing elective cesarean section', 'Exclusion criteria were: psychiatric disorders, neurological impairment, epilepsy, deafness, use of drugs/alcohol during pregnancy, insufficient reading level', 'women undergoing elective caesarean section', 'Participants of groups 1 and 2 will be unaware of the type of audio heard']","['listen an engineered audio track (binaural beat arm) created with the novel algorithm ""Dynamic Spectrum Phase Shift"" (DMSPS), or an identical soundtrack without DMSPS in it (music arm), or no specific intervention, representing standard practice', 'DMSPS algorithm', 'predetermined computer-generated random sequence: (1) ""binaural"" group, (2) ""normal music"" group, and (3) ""control"" group', 'novel binaural beat technique']","['maternal anxiety', 'feeling of anxiety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0014279', 'cui_str': 'Engineering'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",60.0,0.0983318,Binaural beat audio created with DMSPS algorithm provides superior changes in reported anxiety in comparison to normal music and above all to standard care.,"[{'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Parodi', 'Affiliation': 'IBCLC, Maternal and Infant Department, Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Fodde', 'Affiliation': 'Maternal and Infant Department, Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pellecchia', 'Affiliation': 'Maternal and Infant Department, Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Puntoni', 'Affiliation': 'Biostatistics Unit, Scientific Directorate, Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Fracchia', 'Affiliation': 'Vascular Surgery Department, Galliera Hospital, Genoa, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Mazzella', 'Affiliation': 'Director of Maternal and Infant Department, Galliera Hospital, Genoa, Italy.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2020.1751607']
2900,32674675,Reduced Rivaroxaban Dose Versus Dual Antiplatelet Therapy After Left Atrial Appendage Closure: ADRIFT a Randomized Pilot Study.,"BACKGROUND


Percutaneous left atrial appendage closure (LAAC) exposes to the risk of device thrombosis in patients with atrial fibrillation who frequently have a contraindication to full anticoagulation. Thereby, dual antiplatelet therapy (DAPT) is usually preferred. No randomized study has evaluated nonvitamin K antagonist oral anticoagulant after LAAC, and we decided to evaluate the efficacy and safety of reduced doses of rivaroxaban after LAAC.
METHODS


ADRIFT (Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure) is a multicenter, phase IIb study, which randomized 105 patients after successful LAAC to either rivaroxaban 10 mg (R 10 , n=37), rivaroxaban 15 mg (R 15 , n=35), or DAPT with aspirin 75 mg and clopidogrel 75 mg (n=33). The primary end point was thrombin generation (prothrombin fragments 1+2) measured 2 to 4 hours after drug intake, 10 days after treatment initiation. Thrombin-antithrombin complex, D-dimers, rivaroxaban concentrations were also measured at 10 days and 3 months. Clinical end points were evaluated at 3-month follow-up.
RESULTS


The primary end point was reduced with R 10  (179 pmol/L [interquartile range (IQR), 129-273],  P <0.0001) and R 15  (163 pmol/L [IQR, 112-231],  P <0.0001) as compared with DAPT (322 pmol/L [IQR, 218-528]). We observed no significant reduction of the primary end point between R 10  and R 15  while rivaroxaban concentrations increased significantly from 184 ng/mL (IQR, 127-290) with R 10  to 274 ng/mL (IQR, 192-377) with R 15 ,  P <0.0001. Thrombin-antithrombin complex and D-dimers were numerically lower with both rivaroxaban doses than with DAPT. These findings were all confirmed at 3 months. The clinical end points were not different between groups. A device thrombosis was noted in 2 patients assigned to DAPT.
CONCLUSIONS


Thrombin generation measured after LAAC was lower in patients treated by reduced rivaroxaban doses than DAPT, supporting an alternative to the antithrombotic regimens currently used after LAAC and deserves further evaluation in larger studies. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03273322.",2020,Thrombin-antithrombin complex and D-dimers were numerically lower with both rivaroxaban doses than with DAPT.,"['Atrial Fibrillation Patients', '105 patients after successful LAAC to either', 'patients with atrial fibrillation who frequently have a contraindication to full anticoagulation']","['DAPT', 'Dual Antiplatelet Therapy', 'Rivaroxaban', 'DAPT with aspirin 75 mg and clopidogrel', 'dual antiplatelet therapy (DAPT', 'rivaroxaban', 'Percutaneous left atrial appendage closure (LAAC', 'Left Atrial Appendage Closure']","['Thrombin-antithrombin complex, D-dimers, rivaroxaban concentrations', 'rivaroxaban concentrations', 'thrombin generation (prothrombin fragments 1+2', 'Thrombin-antithrombin complex and D-dimers', 'efficacy and safety']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0983879', 'cui_str': 'Aspirin 75 MG'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}]","[{'cui': 'C0052128', 'cui_str': 'Thrombin-antithrombin complex'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",105.0,0.128261,Thrombin-antithrombin complex and D-dimers were numerically lower with both rivaroxaban doses than with DAPT.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Duthoit', 'Affiliation': 'Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).'}, {'ForeName': 'Eloi', 'Initials': 'E', 'LastName': 'Marijon', 'Affiliation': 'European Georges Pompidou Hospital, APHP; Paris Descartes University, INSERM U 970, France (E.M., C.S.).'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Département de Cardiologie, Hôpital Bichat, AP-HP, Université Paris-Diderot, Inserm U1148, France (G.D., E.B., J.-M.J.).'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lepillier', 'Affiliation': 'Department of Cardiology, Centre Cardiologique du Nord, Saint-Denis, France (A.L., D.A.).'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Frere', 'Affiliation': 'Sorbonne Université, Department of Haematology Biologic, APHP Pitié-Salpêtrière Hospital; INSERM UMRS 1166, Institute of Cardiometabolism And Nutrition, Paris, France (C.F., I.M.-T.).'}, {'ForeName': 'Solohaja-Faniaha', 'Initials': 'SF', 'LastName': 'Dimby', 'Affiliation': 'Unité de Recherche Clinique, ACTION Study Group, Hôpital Fernand Widal (AP-HP), SAMM - Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, France (S.-F.D., E.V.).'}, {'ForeName': 'Batric', 'Initials': 'B', 'LastName': 'Popovic', 'Affiliation': 'Université de Lorraine, Département de Cardiologie, Centre Hospitalier Universitaire Brabois, Nancy, France (B.P.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lellouche', 'Affiliation': 'Département de Cardiologie, CHU Henri Mondor, Créteil, France (N.L.).'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Martin-Toutain', 'Affiliation': 'Sorbonne Université, Department of Haematology Biologic, APHP Pitié-Salpêtrière Hospital; INSERM UMRS 1166, Institute of Cardiometabolism And Nutrition, Paris, France (C.F., I.M.-T.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Spaulding', 'Affiliation': 'European Georges Pompidou Hospital, APHP; Paris Descartes University, INSERM U 970, France (E.M., C.S.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Brochet', 'Affiliation': 'Département de Cardiologie, Hôpital Bichat, AP-HP, Université Paris-Diderot, Inserm U1148, France (G.D., E.B., J.-M.J.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Attias', 'Affiliation': 'Department of Cardiology, Centre Cardiologique du Nord, Saint-Denis, France (A.L., D.A.).'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Mansourati', 'Affiliation': 'Département de Cardiologie, CHRU Brest, Université de Bretagne Occidentale, EA 4324 (J.M.).'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Lorgis', 'Affiliation': 'Department of Cardiology, Laboratory of Cerebro-Vascular Pathophysiology and epidemiology (PEC2) EA 7460, University of Burgundy, Dijon, France (L.L.).'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Klug', 'Affiliation': 'Univ. Lille CHU Lille, F-59000 Lille, France (D.K.).'}, {'ForeName': 'Noura', 'Initials': 'N', 'LastName': 'Zannad', 'Affiliation': 'Département de Cardiologie, CHR Metz-Thionville, France (N.Z.).'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Université de Versailles-Saint Quentin, Department of Cardiology, Ambroise Paré Hospital (AP-HP), INSERM U-1018, Boulogne, France (M.H.-M.).'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Braik', 'Affiliation': 'Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Deltour', 'Affiliation': 'Sorbonne Université, Urgences Cerebro-Vasculaires Pitié-Salpêtrière Hospital (AP-HP), INSERM UMR U-942, Paris, France (S.D.).'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Ceccaldi', 'Affiliation': 'Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China (H.W.).'}, {'ForeName': 'Nadjib', 'Initials': 'N', 'LastName': 'Hammoudi', 'Affiliation': 'Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Brugier', 'Affiliation': 'Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique, ACTION Study Group, Hôpital Fernand Widal (AP-HP), SAMM - Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, France (S.-F.D., E.V.).'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Juliard', 'Affiliation': 'Département de Cardiologie, Hôpital Bichat, AP-HP, Université Paris-Diderot, Inserm U1148, France (G.D., E.B., J.-M.J.).'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008481']
2901,32674677,"Letter by Lawson et al Regarding Article, ""Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial"".",,2020,,['Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention'],['DAPT Score'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",[],,0.030414,,"[{'ForeName': 'Lucy Olivia', 'Initials': 'LO', 'LastName': 'Lawson', 'Affiliation': 'Cardiology Department, Royal Free London NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kirresh', 'Affiliation': 'Cardiology Department, Royal Free London NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Shintre', 'Affiliation': 'Cardiology Department, Royal Free London NHS Foundation Trust, United Kingdom.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009612']
2902,32674676,Outcome of Flow-Gradient Patterns of Aortic Stenosis After Aortic Valve Replacement: An Analysis of the PARTNER 2 Trial and Registry.,"BACKGROUND


Although aortic valve replacement is associated with a major benefit in high-gradient (HG) severe aortic stenosis (AS), the results in low-gradient (LG, mean gradient <40 mm Hg) AS are conflicting. LG severe AS may be subdivided in classical low-flow (left ventricular ejection fraction <50%) and LG (CLF-LG); paradoxical low-flow (left ventricular ejection fraction ≥50% but stroke volume index <35 mL/m 2 ) and LG; and normal-flow (left ventricular ejection fraction ≥50% and stroke volume index ≥35 mL/m 2 ) and LG. The primary objective is to determine in the PARTNER 2 trial (The Placement of Aortic Transcatheter Valves) and registry the outcomes after aortic valve replacement of the 4 flow-gradient groups.
METHODS


A total of 3511 patients from the PARTNER 2 Cohort A randomized trial (n=1910) and SAPIEN 3 registry (n=1601) were included. The flow-gradient pattern was determined at baseline transthoracic echocardiography and classified as follows: (1) HG; (2) CLF-LG; (3) paradoxical low-flow-LG; and (4) normal-flow-LG. The primary end point for this analysis was the composite of (1) death; (2) rehospitalization for heart failure symptoms and valve prosthesis complication; or (3) stroke.
RESULTS


The distribution was HG, 2229 patients (63.5%); CLF-LG, 689 patients (19.6%); paradoxical low-flow-LG, 247 patients (7.0%); and normal-flow-LG, 346 patients (9.9%). The 2-year rate of primary end point was higher in CLF-LG (38.8%) versus HG: 31.8% ( P =0.002) and normal-flow-LG: 32.1% ( P =0.05) but was not statistically different from paradoxical low-flow-LG: 33.6% ( P =0.18). There was no significant difference in the 2-year rates of clinical events between transcatheter aortic valve replacement versus surgical aortic valve replacement in the whole cohort and within each flow-gradient group.
CONCLUSIONS


The LG AS pattern was highly prevalent (36.5%) in the PARTNER 2 trial and registry. CLF-LG was the most common pattern of LG AS and was associated with higher rates of death, rehospitalization, or stroke at 2 years compared with the HG group. Clinical outcomes were as good in the LG AS groups with preserved left ventricular ejection fraction compared with the HG group.",2020,"There was no significant difference in the 2-year rates of clinical events between transcatheter aortic valve replacement versus surgical aortic valve replacement in the whole cohort and within each flow-gradient group.
","['After Aortic Valve Replacement', '3511 patients from the PARTNER 2 Cohort A randomized trial (n=1910) and SAPIEN 3 registry (n=1601) were included']","['aortic valve replacement of the 4 flow-gradient groups', 'transcatheter aortic valve replacement versus surgical aortic valve replacement', 'Aortic Transcatheter Valves']","['2-year rate', 'Flow-Gradient Patterns of Aortic Stenosis', 'rates of death, rehospitalization, or stroke', '2-year rates of clinical events', 'left ventricular ejection fraction', 'composite of (1) death; (2) rehospitalization for heart failure symptoms and valve prosthesis complication; or (3) stroke', 'CLF-LG']","[{'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0274320', 'cui_str': 'Complication of internal prosthetic device'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",3511.0,0.0610476,"There was no significant difference in the 2-year rates of clinical events between transcatheter aortic valve replacement versus surgical aortic valve replacement in the whole cohort and within each flow-gradient group.
","[{'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Salaun', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Marie-Annick', 'Initials': 'MA', 'LastName': 'Clavel', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Hahn', 'Affiliation': 'Columbia University Medical Center/New York- Presbyterian Hospital (R.T.H., A.D., Y.Z., M.C.A., M.B.L.).'}, {'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Jaber', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, OH (W.A.J., L.R.).'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute at Washington Hospital Center, DC (F.M.A., N.J.W., V.H.T.).'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, OH (W.A.J., L.R.).'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'MedStar Health Research Institute at Washington Hospital Center, DC (F.M.A., N.J.W., V.H.T.).'}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Gertz', 'Affiliation': 'Division of Cardiology, Virginia Commonwealth University, Richmond (Z.M.G.).'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'University of Pennsylvania Medical Center, Philadelphia (H.C.H.).'}, {'ForeName': 'Abdellaziz', 'Initials': 'A', 'LastName': 'Dahou', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Mohamed-Salah', 'Initials': 'MS', 'LastName': 'Annabi', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Oumhani', 'Initials': 'O', 'LastName': 'Toubal', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bernier', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Beaudoin', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Leipsic', 'Affiliation': ""St Paul's Hospital, Vancouver, British Columbia, Canada (J.L., P.B., J.G.W.).""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Blanke', 'Affiliation': ""St Paul's Hospital, Vancouver, British Columbia, Canada (J.L., P.B., J.G.W.).""}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Ridard', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Ong', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Rodés-Cabau', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""St Paul's Hospital, Vancouver, British Columbia, Canada (J.L., P.B., J.G.W.).""}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Columbia University Medical Center/New York- Presbyterian Hospital (R.T.H., A.D., Y.Z., M.C.A., M.B.L.).'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Columbia University Medical Center/New York- Presbyterian Hospital (R.T.H., A.D., Y.Z., M.C.A., M.B.L.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center and Duke Clinical Research Institute, Durham, NC (P.S.D.).'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, CA (R.M.).'}, {'ForeName': 'D Craig', 'Initials': 'DC', 'LastName': 'Miller', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, CA (D.C.M.).'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lindman', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN (B.R.L.).'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'MedStar Health Research Institute at Washington Hospital Center, DC (F.M.A., N.J.W., V.H.T.).'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Columbia University Medical Center/New York- Presbyterian Hospital (R.T.H., A.D., Y.Z., M.C.A., M.B.L.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Canada (E.S., M.-A.C., A.D., M.-S.A., O.T., M.B., J.B., C.R., G.O., J.R.-C., P.P.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008792']
2903,32674679,"Response by Choi et al to Letter Regarding Article, ""Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial"".",,2020,,['Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention'],['DAPT Score'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",[],,0.0251511,,"[{'ForeName': 'Ki Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Bin', 'Initials': 'YB', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joo-Yong', 'Initials': 'JY', 'LastName': 'Hahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009645']
2904,32674691,Omission of a carbohydrate-rich breakfast impairs evening endurance exercise performance despite complete dietary compensation at lunch.,"Omission of a carbohydrate-rich breakfast followed by consuming an  ad libitum  lunch impairs evening exercise performance. However, it is unclear if this is due to breakfast omission  per se , or secondary to lower carbohydrate intake over the day. To test whether impaired evening performance following breakfast omission persists when complete dietary compensation occurs at lunch, in a randomised cross-over design, eleven highly trained cyclists (age: 25 ± 7 y, VO 2 max: 61 ± 5 ml·kg -1 ·min -1 ) completed two trials: breakfast (B) and no breakfast (NB). During B, participants consumed an individualised breakfast (583±54 kcal; 8-9am) and lunch (874±80 kcal; 12-2pm), whilst during NB participants fasted until 12pm and then consumed a standardised lunch (1457±134 kcal: 12-2pm). The overall energy (1457±134 kcal) and macronutrient profile (carbohydrate: 81.5±0.4%, fat: 5.8±0.1%, protein: 12.7±0.3%) was identical in both trials, with timing the only difference. Mean power output during a 20 km time trial performed in the evening was ∼3% lower in NB compared to B (mean difference [95% CI]: -9.1 [-15.3, -2.9] watts,  p <0.01 for condition main effect). No differences in heart rate, blood glucose or blood lactate concentrations were apparent, but perception of effort appeared to be higher in the early stages of the time trial in NB compared to B despite lower power output. Impaired high-intensity endurance performance in the evening following breakfast omission is related to meal timing rather than carbohydrate intake / availability. Provision of an early morning high-carbohydrate meal should be considered to optimise evening exercise performance.",2020,"No differences in heart rate, blood glucose or blood lactate concentrations were apparent, but perception of effort appeared to be higher in the early stages of the time trial in NB compared to B despite lower power output.","['eleven highly trained cyclists (age: 25 ± 7 y, VO 2 max: 61 ± 5 ml·kg -1 ·min -1 ) completed two trials']","['breakfast (B) and no breakfast (NB', 'carbohydrate-rich breakfast']","['Mean power output', 'heart rate, blood glucose or blood lactate concentrations', 'evening exercise performance', 'Impaired high-intensity endurance performance']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",11.0,0.153908,"No differences in heart rate, blood glucose or blood lactate concentrations were apparent, but perception of effort appeared to be higher in the early stages of the time trial in NB compared to B despite lower power output.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Metcalfe', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre, Swansea University, Wales, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre, Swansea University, Wales, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lamb', 'Affiliation': 'Applied Sports Technology Exercise and Medicine Research Centre, Swansea University, Wales, UK.'}, {'ForeName': 'Enhad A', 'Initials': 'EA', 'LastName': 'Chowdhury', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1797890']
2905,32675291,"Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation.","INTRODUCTION


A growing body of evidence suggests that specific, naturally occurring gut bacteria are under-represented in the intestinal tracts of subjects with type 2 diabetes (T2D) and that their functions, like gut barrier stability and butyrate production, are important to glucose and insulin homeostasis. The objective of this study was to test the hypothesis that enteral exposure to microbes with these proposed functions can safely improve clinical measures of glycemic control and thereby play a role in the overall dietary management of diabetes.
RESEARCH DESIGN AND METHODS


We evaluated whether a probiotic comprised of these anaerobic bacteria would enhance dietary management by (1) manufacturing two novel probiotic formulations containing three (WBF-010) or five (WBF-011) distinct strains in a Current Good Manufacturing Practice (cGMP) facility, (2) establishing consistent live-cell concentrations, (3) confirming safety at target concentrations dispensed in both animal and human studies and (4) conducting a 12-week parallel, double-blind, placebo-controlled, proof-of-concept study in which subjects previously diagnosed with T2D (n=76) were randomly assigned to a two times a day regimen of placebo, WBF-010 or WBF-011.
RESULTS


No safety or tolerability issues were observed. Compared with the placebo group, subjects administered WBF-011 (which contains inulin,  Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Bifidobacterium infantis  and  Anaerobutyricum hallii ) significantly improved in the primary outcome, glucose total area under the curve (AUC): -36.1 mg/dL/180 min, p=0.0500 and also improved in secondary outcomes, glycated hemoglobin (A1c): -0.6, glucose incremental-AUC: -28.6 mg/dL/180 min.
CONCLUSIONS


To our knowledge, this is the first randomized controlled trial to administer four of the five strains to human subjects with T2D. This proof-of-concept study (clinical trial number NCT03893422) shows that the intervention was safe and well tolerated and that supplementation with WBF-011 improves postprandial glucose control. The limited sample size and intersubject variability justifies future studies designed to confirm and expand on these observations.",2020,No safety or tolerability issues were observed.,"['human subjects with T2D', 'subjects with type 2 diabetes', 'subjects previously diagnosed with T2D (n=76']","['placebo, WBF-010 or WBF-011.\nRESULTS', 'WBF-011', 'placebo']","['glucose total area under the curve (AUC', 'postprandial glucose control', 'secondary outcomes, glycated hemoglobin (A1c): -0.6, glucose incremental-AUC', 'safe and well tolerated']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4068883', 'cui_str': '0.6'}]",76.0,0.155382,No safety or tolerability issues were observed.,"[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Perraudeau', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McMurdie', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bullard', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Cutcliffe', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Achal', 'Initials': 'A', 'LastName': 'Deo', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eid', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gines', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Iyer', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Justice', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Loo', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Nemchek', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schicklberger', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Souza', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stoneburner', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Tyagi', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA.'}, {'ForeName': 'Orville', 'Initials': 'O', 'LastName': 'Kolterman', 'Affiliation': 'Pendulum Therapeutics, Inc, San Francisco, California, USA orville.kolterman@pendulum.co.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001319']
2906,32675297,Vitamin K for kidney transplant organ recipients: investigating vessel stiffness (ViKTORIES): study rationale and protocol of a randomised controlled trial.,"BACKGROUND


Renal transplant recipients (RTRs) exhibit increased vascular stiffness and calcification; these parameters are associated with increased cardiovascular risk. Activity of endogenous calcification inhibitors such as matrix gla protein (MGP) is dependent on vitamin K. RTRs commonly have subclinical vitamin K deficiency. The Vitamin K in kidney Transplant Organ Recipients: Investigating vEssel Stiffness (ViKTORIES) study assesses whether vitamin K supplementation reduces vascular stiffness and calcification in a diverse population of RTR.
METHODS AND ANALYSIS


ViKTORIES (ISRCTN22012044) is a single-centre, phase II, parallel-group, randomised, double-blind, placebo-controlled trial of the effect of vitamin K supplementation in 90 prevalent RTR. Participants are eligible if they have a functioning renal transplant for  > 1 year. Those on warfarin, with atrial fibrillation, estimated glomerular filtration rate <15 mL/min/1.73 m 2  or contraindications to MRI are excluded. Treatment is with vitamin K (menadiol diphosphate) 5 mg three times per week for 1 year or matching placebo. All participants have primary and secondary endpoint measures at 0 and 12 months. The primary endpoint is ascending aortic distensibility on cardiac MR imaging. Secondary endpoints include vascular calcification (coronary artery calcium score by CT), cardiac structure and function on MR, carotid-femoral pulse wave velocity, serum uncarboxylated MGP, transplant function, proteinuria and quality of life. The study is powered to detect 1.0×10 -3  mm Hg -1  improvement in ascending aortic distensibility in the vitamin K group relative to placebo at 12 months. Analyses will be conducted as between-group differences at 12 months by intention to treat.
DISCUSSION


This trial may identify a novel, inexpensive and low-risk treatment to improve surrogate markers of cardiovascular risk in RTR.",2020,The study is powered to detect 1.0×10 -3  mm Hg -1  improvement in ascending aortic distensibility in the vitamin K group relative to placebo at 12 months.,"['kidney Transplant Organ Recipients', '90 prevalent RTR', 'Participants are eligible if they have a functioning renal transplant for  > 1 year', 'kidney transplant organ recipients']","['Vitamin K', 'vitamin K (menadiol diphosphate', 'vitamin K supplementation', 'placebo']","['glomerular filtration rate', 'ascending aortic distensibility on cardiac MR imaging', 'ascending aortic distensibility', 'vascular calcification (coronary artery calcium score by CT), cardiac structure and function on MR, carotid-femoral pulse wave velocity, serum uncarboxylated MGP, transplant function, proteinuria and quality of life']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0065933', 'cui_str': 'menadiol diphosphate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C2825178', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065752', 'cui_str': 'matrix Gla protein'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.639054,The study is powered to detect 1.0×10 -3  mm Hg -1  improvement in ascending aortic distensibility in the vitamin K group relative to placebo at 12 months.,"[{'ForeName': 'Jennifer Susan', 'Initials': 'JS', 'LastName': 'Lees', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK jennifer.lees2@nhs.net.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Rutherford', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'AGE Research Group, NIHR Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Woodward', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Hopkins', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Katriona', 'Initials': 'K', 'LastName': 'Brooksbank', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Jardine', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}]",Open heart,['10.1136/openhrt-2019-001070']
2907,32675334,Parental Perspectives on Continuous Pulse Oximetry Use in Bronchiolitis Hospitalizations.,"BACKGROUND


Because of the impact of continuous pulse oximetry (CPOX) on the overdiagnosis of hypoxemia in bronchiolitis, the American Academy of Pediatrics and the Choosing Wisely campaign have issued recommendations for intermittent monitoring. Parental preferences for monitoring may impact adoption of these recommendations, but these perspectives are poorly understood.
METHODS


Using this cross-sectional survey, we explored parental perspectives on CPOX monitoring before discharge and 1 week after bronchiolitis hospitalizations. During the 1-week call, half of the participants were randomly assigned to receive a verbal statement on the potential harms of CPOX to determine if conveying the concept of overdiagnosis can change parental preferences on monitoring frequency. An aggregate variable measuring favorable perceptions of CPOX was created to determine CPOX affinity predictors.
RESULTS


In-hospital interviews were completed on 357 patients, of which 306 (86%) completed the 1-week follow-up. Although 25% of parents agreed or strongly agreed that hospital monitors made them feel anxious, 98% agreed that the monitors were helpful. Compared to other vital signs, respiratory rate (87%) and oxygen saturation (84%) were commonly rated as ""extremely important."" Providing an educational statement on CPOX comparatively decreased parental desire for continuous monitoring (40% vs 20%;  P  < .001). Although there were no significant predictors of CPOX affinity, the effect size of the educational intervention was higher in college-educated parents.
CONCLUSIONS


Parents find security in CPOX. A brief statement on the potential harms of CPOX use had an impact on stated monitoring preferences. Parental perspectives are important to consider because they may influence the adoption of intermittent monitoring.",2020,Providing an educational statement on CPOX comparatively decreased parental desire for continuous monitoring (40% vs 20%;  P  < .001).,['Bronchiolitis Hospitalizations'],"['continuous pulse oximetry (CPOX', 'verbal statement']","['respiratory rate', 'oxygen saturation']","[{'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1960498', 'cui_str': 'Continuous pulse oximetry'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.0345223,Providing an educational statement on CPOX comparatively decreased parental desire for continuous monitoring (40% vs 20%;  P  < .001).,"[{'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Chi', 'Affiliation': ""Division of Pediatric Hospital Medicine, Department of Pediatrics, Lucile Packard Children's Hospital Stanford and School of Medicine, Stanford University, Stanford, California; and kevinchi@stanford.edu.""}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Coon', 'Affiliation': ""Department of Pediatrics, School of Medicine, University of Utah and Primary Children's Hospital, Salt Lake City, Utah.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Destino', 'Affiliation': ""Division of Pediatric Hospital Medicine, Department of Pediatrics, Lucile Packard Children's Hospital Stanford and School of Medicine, Stanford University, Stanford, California; and.""}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Schroeder', 'Affiliation': ""Division of Pediatric Hospital Medicine, Department of Pediatrics, Lucile Packard Children's Hospital Stanford and School of Medicine, Stanford University, Stanford, California; and.""}]",Pediatrics,['10.1542/peds.2020-0130']
2908,32675389,Comparison of Short Versus Long Esophageal Myotomy in Cases With Idiopathic Achalasia: A Randomized Controlled Trial.,"Background/Aims


Per-oral endoscopic myotomy (POEM) is an established treatment for achalasia. The technique of POEM is still evolving and the impact of length of esophageal myotomy on the outcomes of POEM is not known. In this study, we aim to compare the outcomes of short (3 cm) versus long (6 cm and above) esophageal myotomy in patients undergoing POEM for achalasia cardia.
Methods


Consecutive patients with idiopathic achalasia (type I and II) were randomized to receive short (3 cm) or long esophageal myotomy (≥ 6 cm). Both groups were compared for clinical success, operative time, adverse events, and gastroesophageal reflux disease (GERD).
Results


Seventy-one consecutive patients with type I and II achalasia underwent POEM with short (n = 34) or long (n = 37) esophageal myotomy techniques. Mean length of esophageal myotomy in short and long groups was 2.76 ± 0.41 and 7.97 ± 2.40, respectively ( P  < 0.001). Mean operative time was significantly shorter in short myotomy group (44.03 ± 13.78 minutes and 72.43 ± 27.28 minutes,  P  < 0.001). Clinical success was comparable in both arms at 1-year (Eckardt score 0.935 ± 0.929 vs 0.818 ± 0.983,  P  = 0.627). Improvement in objective parameters including integrated relaxation pressure and barium column height at 5 minutes was similar in both groups. GERD was detected in 50.88% patients with no significant difference in short and long myotomy groups (44.44% vs 56.67%,  P  = 0.431).
Conclusions


A short esophageal myotomy is non-inferior to long myotomy with regards to clinical success, adverse events, and GERD in cases with type I and II achalasia. Reduced operating duration favors short esophageal myotomy in these patients.",2020,Clinical success was comparable in both arms at 1-year,"['Results\n\n\nSeventy-one consecutive patients with type I and II achalasia underwent POEM with short (n = 34) or long (n = 37) esophageal myotomy techniques', 'patients undergoing POEM for achalasia cardia', 'Consecutive patients with idiopathic achalasia (type I and II', 'Cases With Idiopathic Achalasia']","['/Aims\n\n\nPer-oral endoscopic myotomy (POEM', 'Short Versus Long Esophageal Myotomy']","['Mean operative time', 'Clinical success', 'Mean length of esophageal myotomy', 'integrated relaxation pressure and barium column height', 'clinical success, operative time, adverse events, and gastroesophageal reflux disease (GERD', 'GERD']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0859976', 'cui_str': 'Idiopathic achalasia of esophagus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0472946', 'cui_str': 'Long esophageal myotomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004749', 'cui_str': 'Barium'}, {'cui': 'C1185738', 'cui_str': 'Column structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]",71.0,0.122639,Clinical success was comparable in both arms at 1-year,"[{'ForeName': 'Zaheer', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Ramchandani', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Mahiboob', 'Initials': 'M', 'LastName': 'Sayyed', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Chavan', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Darisetty', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Goud', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Hv Vivekananda', 'Initials': 'HV', 'LastName': 'Murthy', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'D Nageshwar', 'Initials': 'DN', 'LastName': 'Reddy', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20022']
2909,32675390,Efficacy of the lumbar stabilization and thoracic mobilization exercise program on pain intensity and functional disability reduction in chronic low back pain patients with lumbar radiculopathy: A randomized controlled trial.,"BACKGROUND


Exercise programs in the treatment of chronic lumbar pain are quite diverse, but it has been proven that stabilization exercises are the most effective.
OBJECTIVE


We compared the lumbar stabilization exercise program in a closed and open kinetic chain (LSCO) and lumbar stabilization exercises and thoracic mobilization program in a closed kinetic chain (LSTMC), and evaluated the clinical effectiveness of each program.
METHODS


Prospective, randomized, controlled trial in 80 chronic low back pain (CLBP) patients with lumbar radiculopathy of both sexes (35 male, 45 female), average age (48.45 ± 10.22 years), divided in two groups that performed different sets of exercises. Participants were given laser therapy, transcutaneous electro-nerve stimulation and an eight-week kinesiotherapy that included exercises to strengthen the deep lumbar spine stabilizers. Retesting was done after four and eight weeks.
RESULTS


Statistically significant (p< 0.05) superior recovery of the LSTMC group subjects compared to the LSCO group was achieved at all measurement intervals in the pain intensity and functional disability parameters.
CONCLUSION


Patients who performed the lumbar stabilization and thoracic mobilization exercise program in a closed kinetic chain had the most effective reduction of pain intensity and functional disability.",2020,"Statistically significant (p< 0.05) superior recovery of the LSTMC group subjects compared to the LSCO group was achieved at all measurement intervals in the pain intensity and functional disability parameters.
","['chronic low back pain patients with lumbar radiculopathy', '80 chronic low back pain (CLBP) patients with lumbar radiculopathy of both sexes (35 male, 45 female), average age (48.45 ± 10.22 years']","['open kinetic chain (LSCO) and lumbar stabilization exercises and thoracic mobilization program', 'lumbar stabilization and thoracic mobilization exercise program', 'laser therapy, transcutaneous electro-nerve stimulation and an eight-week kinesiotherapy that included exercises to strengthen the deep lumbar spine stabilizers', 'lumbar stabilization exercise program', 'thoracic mobilization exercise program', 'LSCO']","['pain intensity and functional disability reduction', 'pain intensity and functional disability', 'pain intensity and functional disability parameters']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1096702', 'cui_str': 'Kinesitherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",80.0,0.041617,"Statistically significant (p< 0.05) superior recovery of the LSTMC group subjects compared to the LSCO group was achieved at all measurement intervals in the pain intensity and functional disability parameters.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kostadinović', 'Affiliation': 'Medical Faculty, University of Novi Sad, Clinical Research, Novi Sad, Serbia.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Milovanović', 'Affiliation': 'Rehabilitation Clinic ""Dr. Miroslav Zotović"" Belgrade, University of Belgrade, School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Jovanović', 'Affiliation': 'Rehabilitation Clinic ""Dr. Miroslav Zotović"" Belgrade, University of Belgrade, School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Snežana', 'Initials': 'S', 'LastName': 'Tomašević-Todorović', 'Affiliation': 'Medical Faculty, University of Novi Sad, Medical Rehabilitation Clinic, Clinical Centre of Vojvodina, Novi Sad, Serbia.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-201843']
2910,32675483,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","['79 ileocolic CD patients', ""Crohn's Disease""]",['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis'],"['SR rate', 'severe postoperative ER', 'postoperative outcomes', 'clinical recurrence (CR', 'endoscopic recurrence (ER) ', 'reduced risk of ER', 'endoscopic recurrence score and surgical recurrence rate', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'surgical recurrence (SR', 'longer time until CR']","[{'cui': 'C0450203', 'cui_str': 'Ileocolic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic'}, {'cui': 'C0332856', 'cui_str': 'Anastomosis, side to side'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",79.0,0.161354,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
2911,32675536,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2020,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'absorbable or nonabsorbable mesh repair']","['chest pain, diarrhea, and bloat symptoms', 'clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}]","[{'cui': 'C0014857', 'cui_str': 'Repair of paraesophageal diaphragmatic hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0450093', 'cui_str': 'Very large'}, {'cui': 'C0376710', 'cui_str': 'Sliding hiatus hernia'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdominal bloating'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
2912,32675537,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 7.9 (95% confidence interval: 1.0-62.4)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2020,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'One hundred twenty-two patients received', '304 patients were randomized', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution', 'simple appendicitis (SA) in children']","['placebo', 'placebo or antibiotics (Abx', 'Laparoscopic Appendicectomy', 'laparoscopic appendicectomy']","['incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation', 'WI rates', 'postoperative length of stay in a hospital', 'intra-abdominal abscess']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",304.0,0.815373,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
2913,32675541,Evidence-based Reviews in Surgery Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: Five-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial).,"QUESTION


Does surgery or conservative management of recurring diverticulitis/ongoing symptoms results in a higher quality of life (QoL) at 5-year follow-up.
DESIGN


Randomized controlled trial.
SETTING


Multicenter trial in the Netherlands.
PATIENTS


Patients aged 18 to 75 years, who presented with either ongoing abdominal complaints (for >3 months) and/or frequently recurring left-sided diverticulitis (>2 episodes in 2 years) after an objectified (via Computed Tomography, Ultrasound or Endoscopy) episode of diverticulitis were included in this study.
INTERVENTION


Elective Sigmoid Resection within 6 weeks vs. Conservative Management MAIN OUTCOME:: QoL at 5-year follow-up, as measured by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes included additional QoL assessments (including the EuroQoL-5D-3L, Visual Analogue Score for pain, and the short form 36 health survey) RESULTS:: The intention to treat analysis showed the surgical group had a higher quality of life (GIQLI) score than the conservative group (mean difference 9.7, 95% confidence interval 1.7-17.7, P = 0.018), which approached but did not meet the minimum important difference of 10. This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
CONCLUSIONS


The study results demonstrate that HRQOL at 5-year follow-up may be improved in patients undergoing surgical resection, although this difference did not meet the MID for the GIQLI.",2020,"This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
","['patients undergoing surgical resection', 'Patients aged 18 to 75 years, who presented with either ongoing abdominal complaints (for >3 months) and/or frequently recurring left-sided diverticulitis (>2 episodes in 2 years) after an objectified (via Computed Tomography, Ultrasound or Endoscopy) episode of diverticulitis were included in this study', 'Multicenter trial in the Netherlands']","['Surgery Versus Conservative Management', 'Elective Sigmoid Resection']","['Gastrointestinal Quality of Life Index (GIQLI', 'additional QoL assessments (including the EuroQoL-5D-3L, Visual Analogue Score for pain, and the short form 36 health survey', 'higher quality of life (GIQLI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid colon structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.183572,"This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
","[{'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': ""Department of Surgery Queen's University, Kingston, Canada.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hendren', 'Affiliation': 'Department of Surgery University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zaborowski', 'Affiliation': ""Centre for Colorectal Disease St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Des', 'Initials': 'D', 'LastName': 'Winter', 'Affiliation': ""Centre for Colorectal Disease St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003920']
2914,32677999,"eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men.","BACKGROUND


HIV disproportionately affects men who have sex with men (MSM) in the USA, and new infections continue to increase, particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. HIV self-testing (HST) may be an important tool for increasing rates and frequency of testing. HST may be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care.
METHODS


We developed a mobile health platform (eTest) that monitors when HST users open their tests in real time, allowing us to provide timely, ""active"" follow-up counseling and referral over the phone. In this study, 900 high-risk MSM (with targets of 40% AA, 35% H/L) who have not tested in the last year will be recruited from social media and other gay-oriented websites in several major cities. Over 12 months, participants will be randomly assigned to receive (1) HST with post-test phone counseling and referral (eTest condition), (2) HST without active follow-up (standard condition), or (3) reminders to get tested for HIV at a local clinic (control) every 3 months. Primary outcomes include rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation verified by clinical medical records.
DISCUSSION


This study tests whether providing more active counseling and referral after HST encourages more regular HIV testing and engagement with other prevention services among MSM, compared to more passive approaches or clinic-based testing alone. It will also explore the cost-effectiveness and emotional/behavioral effects of these two strategies.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03654690 . Registered on 31 August 2018.",2020,"This study tests whether providing more active counseling and referral after HST encourages more regular HIV testing and engagement with other prevention services among MSM, compared to more passive approaches or clinic-based testing alone.","['HIV disproportionately affects men who have sex with men (MSM', 'high-risk men who have sex with men', '900 high-risk MSM (with targets of 40% AA, 35% H/L) who have not tested in the last year will be recruited from social media and other gay-oriented websites in several major cities']","['HIV self-testing (HST', 'mobile health platform that enables real-time phone counseling', 'HST', 'HST with post-test phone counseling and referral (eTest condition), (2) HST without active follow-up (standard condition), or (3) reminders to get tested for HIV at a local clinic (control) every 3\xa0months']","['cost-effectiveness and emotional/behavioral effects', 'rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation verified by clinical medical records']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C3850116', 'cui_str': 'Etest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}]",900.0,0.169923,"This study tests whether providing more active counseling and referral after HST encourages more regular HIV testing and engagement with other prevention services among MSM, compared to more passive approaches or clinic-based testing alone.","[{'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Wray', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA. tyler_wray@brown.edu.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Chan', 'Affiliation': 'Division of Infectious Diseases, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Klausner', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California - Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Leandro A', 'Initials': 'LA', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Sciences, John D. Bower School of Population Health, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Brock', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, School of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Simpanen', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Ward', 'Affiliation': 'Department of Population Health Sciences, John D. Bower School of Population Health, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Stafylis', 'Initials': 'S', 'LastName': 'Chrysovalantis', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California - Los Angeles, Los Angeles, CA, USA.'}]",Trials,['10.1186/s13063-020-04554-1']
2915,32678005,Process evaluation of a complex intervention to promote advance care planning in community-dwelling older persons (the STADPLAN study)-study protocol.,"BACKGROUND


Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators. The complex intervention consists of several components that may lead to various changes in attitude and behavior regarding personal ACP activities. With the process evaluation, we aim to assess how changes were achieved in the STADPLAN intervention.
METHODS


The planned process evaluation study will be conducted alongside a cluster-randomized controlled trial on ACP in home care services (HCS). Trained nurse facilitators will deliver the ACP intervention consisting of an information brochure and two ACP conversations. A logic model depicts the assumed change processes of the intervention: the educational program enables nurses to conduct ACP conversations with patients and their caregivers. Patients gain knowledge and reflect upon and engage in their own ACP. Caregivers better understand patients' wishes and feel reassured in their role as surrogates. Designation of a surrogate and communication on ACP are facilitated. We will assess the effects of the educational program with questionnaires and a focus group including all participating nurses. We will measure ACP engagement, and prevalence of advance directives in patients, and ask for their experiences with the intervention. We will conduct semi-structured interviews with caregivers about their expectations and experiences regarding ACP in general and the intervention. We will address context factors, e.g., basic characteristics of the HCS (such as ownership, number of clients, staff and qualification). Analysis will be based upon the logic model, integrating qualitative and quantitative data.
DISCUSSION


The comprehensive process evaluation will provide essential information on the feasibility of implementation strategies and the clinical relevance of a nurse-led ACP intervention in home care recipients and its generalizability and transferability to other settings.
TRIAL REGISTRATION


German Clinical Trials Register: DRKS00016886 . Registered retrospectively on June 4, 2019, first participant included on May 29, 2019.",2020,The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators.,"['community-dwelling older persons', 'Registered retrospectively on June 4, 2019, first participant included on May 29, 2019']","['advance care planning (ACP', 'ACP', 'ACP intervention', 'complex intervention']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",[],,0.0454776,The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators.,"[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Silies', 'Affiliation': 'Institute for Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. Katharina.silies@uksh.de.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Schnakenberg', 'Affiliation': 'Department for Health Services Research, Faculty of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Ammerländer Heerstraße 140, 26129, Oldenburg, Germany. rieke.schnakenberg@uni-oldenburg.de.'}, {'ForeName': 'Almuth', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Änne', 'Initials': 'Ä', 'LastName': 'Kirchner', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Langner', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Rainer-Gruenter-Straße 21, 42119, Wuppertal, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Hoffmann', 'Affiliation': 'Department for Health Services Research, Faculty of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Ammerländer Heerstraße 140, 26129, Oldenburg, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute for Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.'}]",Trials,['10.1186/s13063-020-04529-2']
2916,32678026,"A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial.","BACKGROUND


It is estimated that 55 million adults will be 65 years and older in the USA by 2020. These older adults are at increased risk for injury and their recovery is multi-faceted. A collaborative care model may improve psychological and functional outcomes of the non-neurologically impaired older trauma patient and reduce health care costs.
METHODS


This is a randomized controlled trial of 430 patients aged 50 and older who have suffered a non-neurologic injury and are admitted to a level one trauma center in Indianapolis, IN, or Madison, WI. Participants will be assigned to either the Trauma Medical Home (TMH) intervention or usual care. The TMH intervention is a collaborative care model that includes validated protocols addressing the multi-faceted needs of this population, with the help of care coordination software and a mobile office concept. The primary outcome is self-reported physical recovery at 6- and 12-month follow-up. Secondary outcomes include self-reported psychological recovery, acute health care utilization, and cost-effectiveness of the intervention at 6 and 12 months. The TMH collaborative care model will be delivered by a registered nurse care coordinator. The assessments will be completed by trained blinded research assistants.
DISCUSSION


The proposed study will evaluate a collaborative care model to help maximize psychological and functional recovery for non-neurologically injured older patients at four level one trauma centers in the Midwest.
TRIAL REGISTRATION


Clinical Trials. NCT03108820 . Registered on 11 April 2017. Protocol Version 6: Study # 1612690852. April 12, 2019.
SPONSOR


Indiana University. Human subjects and IRB contact information: irb@iu.edu Prospectively registered in the WHO ICTRP on 4 June 2017.",2020,"A collaborative care model may improve psychological and functional outcomes of the non-neurologically impaired older trauma patient and reduce health care costs.
","['non-neurologically injured older patients at four level one trauma centers in the Midwest', '430 patients aged 50 and older who have suffered a non-neurologic injury and are admitted to a level one trauma center in Indianapolis, IN, or Madison, WI', '55 million adults will be 65\u2009years and older in the USA by 2020', 'older injured patient', 'Human subjects and IRB contact information: irb@iu.edu Prospectively registered in the WHO ICTRP on 4 June 2017']","['Trauma Medical Home (TMH) intervention or usual care', 'TMH intervention']","['self-reported psychological recovery, acute health care utilization, and cost-effectiveness of the intervention at 6 and 12\xa0months', 'self-reported physical recovery']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C2713310', 'cui_str': 'Medical Home'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",430.0,0.125255,"A collaborative care model may improve psychological and functional outcomes of the non-neurologically impaired older trauma patient and reduce health care costs.
","[{'ForeName': 'Damaris', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., Emerson Hall, Indianapolis, IN, 46202, USA. damaorti@iu.edu.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Meagher', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., Emerson Hall, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lindroth', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, 1120 W. Michigan St., CL 260, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Holler', 'Affiliation': 'Sidney & Lois Eskenazi Hospital Smith Level One Trauma Center, 720 Eskenazi Ave, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Center of Health Innovation and Implementation Science, Center for Translational Science and Innovation, 410 W. 10th St., Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, 1120 W. Michigan St., CL 260, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lasiter', 'Affiliation': 'School of Nursing and Health Studies, University of Missouri, 2464 Charlotte St, Kansas City, MO, 64108, USA.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Center of Health Innovation and Implementation Science, Center for Translational Science and Innovation, 410 W. 10th St., Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Zarzaur', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health-Madison, 600 Highland Ave., Madison, WI, 53792, USA.'}]",Trials,['10.1186/s13063-020-04582-x']
2917,32678041,"Effect of electroacupuncture versus solifenacin for moderate and severe overactive bladder: a multi-centre, randomized controlled trial study protocol.","BACKGROUND


Overactive bladder is defined as ""urgency, with or without urge incontinence, usually with frequency and nocturia"". Electroacupuncture may be a safe and an effective alternative therapy for overactive bladder, but the evidence is limited.
METHODS


We will conduct a three-arm, non-inferiority, multi-centre randomized controlled clinical trial. A total of 420 patients with moderate and severe overactive bladder will be randomly assigned to one of three groups: the electroacupuncture group (N = 140), sham electroacupuncture group (N = 140), and solifenacin group (N = 140). The primary outcome will be the change in the overactive bladder symptom score from baseline to the end of the 12-week treatment. The secondary outcomes will include the proportion of participants with a decrease in the overactive bladder symptom score ≥ 3 at weeks 4, 8, 12, 20, and 32; the change in average 24 h values of urination, nocturnal urination, urgency incontinence and urgency episodes from baseline to weeks 4, 8, 12, 20 and 32, and so forth. The adverse events will be recorded. Statistical analysis will include covariance analysis, nonparametric tests and descriptive statistics.
DISCUSSION


This study will answer the question of whether electroacupuncture is effective and non-inferior to solifenacin for improving the symptoms of overactive bladder patients.
TRIAL REGISTRATION


Chinese clinical trial registry ( ChiCTR1800019928 ).",2020,"Electroacupuncture may be a safe and an effective alternative therapy for overactive bladder, but the evidence is limited.
","['moderate and severe overactive bladder', 'overactive bladder patients', '420 patients with moderate and severe overactive bladder']","['electroacupuncture group (N\u2009=\u2009140), sham electroacupuncture', 'Electroacupuncture', 'electroacupuncture', 'solifenacin']","['adverse events', 'change in average 24\u2009h values of urination, nocturnal urination, urgency incontinence and urgency episodes', 'overactive bladder symptom score']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",420.0,0.206234,"Electroacupuncture may be a safe and an effective alternative therapy for overactive bladder, but the evidence is limited.
","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wen', 'Affiliation': 'Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fengwei', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Department of acupuncture and moxibustion, Chongqing hospital of traditional Chinese medicine, Chongqing, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of acupuncture and moxibustion, Subei people's hospital of Jiangsu province, Yangzhou, China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of acupuncture and moxibustion, Jiangbin hospital of Guangxi Zhuang autonomous region, Nanning, China.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No.5 Beixiange Street, Beijing, Xicheng District, China. liuzhishun@aliyun.com.""}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03018-y']
2918,32678068,Reducing Anxiety and Anxiety Sensitivity With High-Intensity Interval Training in Adults With Asthma.,"BACKGROUND


Low- and moderate-intensity exercise training has been shown to be effective for reducing general anxiety and anxiety sensitivity among adults with asthma. Exercise frequency and intensity have been shown to play an integral role in reducing anxiety sensitivity; however, less is known about the impact of high-intensity interval training (HIIT) on anxiety in adults with asthma.
METHODS


A 6-week HIIT intervention was conducted with adults with asthma. Participants completed HIIT (10% peak power output for 1 min, 90% peak power output for 1 min, repeated 10 times) 3 times per week on a cycle ergometer. Preintervention and postintervention assessments included the Anxiety Sensitivity Index-3 and the Body Sensations Questionnaire.
RESULTS


Total Anxiety Sensitivity Index-3 (PRE: 17.9 [11.8]; POST 12.4 [13], P = .002, Cohen d = 0.4, n = 20) and Body Sensations Questionnaire (PRE: 2.4 [1.0]; POST: 2.0 [0.8], P = .007, Cohen d = 0.3) improved from preintervention to postintervention.
CONCLUSION


A 6-week HIIT intervention leads to improved anxiety among adults with asthma. Future research should determine the impact of HIIT among adults with asthma with clinical anxiety.",2020,"RESULTS


Total Anxiety Sensitivity Index-3","['adults with asthma', 'adults with asthma with clinical anxiety', 'Adults With Asthma']","['HIIT intervention', 'Low- and moderate-intensity exercise training', 'High-Intensity Interval Training']","['anxiety', 'general anxiety and anxiety sensitivity', 'Reducing Anxiety and Anxiety Sensitivity', 'Total Anxiety Sensitivity Index-3', 'Anxiety Sensitivity Index-3 and the Body Sensations Questionnaire', 'Body Sensations Questionnaire']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0263981,"RESULTS


Total Anxiety Sensitivity Index-3","[{'ForeName': 'Carley', 'Initials': 'C', 'LastName': ""O'Neill"", 'Affiliation': ''}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Dogra', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0521']
2919,32678082,Vagus nerve stimulation boosts the drive to work for rewards.,"Interoceptive feedback transmitted via the vagus nerve plays a vital role in motivation by tuning actions according to physiological needs. Whereas vagus nerve stimulation (VNS) reinforces actions in animals, motivational effects elicited by VNS in humans are still largely elusive. Here, we applied non-invasive transcutaneous auricular VNS (taVNS) on the left or right ear while participants exerted effort to earn rewards using a randomized cross-over design (vs. sham). In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards. In contrast, we do not find conclusive evidence that acute taVNS affects effort maintenance or wanting ratings. Collectively, our results suggest that taVNS enhances reward-seeking by boosting invigoration, not effort maintenance and that the stimulation side affects generalization beyond food reward. Thus, taVNS may enhance the pursuit of prospective rewards which may pave avenues to treat motivational deficiencies.",2020,"In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards.",[],"['vagus nerve stimulation (VNS', 'invasive transcutaneous auricular VNS (taVNS']",[],[],"[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}]",[],,0.0294214,"In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards.","[{'ForeName': 'Monja P', 'Initials': 'MP', 'LastName': 'Neuser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teckentrup', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kühnel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Hallschmid', 'Affiliation': 'Department of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Otfried-Müller-Straße 25, 72076, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Nils B', 'Initials': 'NB', 'LastName': 'Kroemer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany. nils.kroemer@uni-tuebingen.de.'}]",Nature communications,['10.1038/s41467-020-17344-9']
2920,32675583,Impact of Electroacupuncture Stimulation on Postoperative Constipation for Patients Undergoing Brain Tumor Surgery.,"BACKGROUND


Constipation is frequently encountered in patients undergoing brain tumor resection. Constipation has negative effects on daily living, well-being, and individuals' quality of life. We examined the impact of acupuncture and electroacupuncture (EA) stimulation on postoperative constipation for patients undergoing brain tumor resection.
METHODS


Patients undergoing brain tumor resection (n = 150) were randomly divided into a nontreatment group, an acupuncture group, and an EA group. Rome III Diagnostic Criteria, Cleveland Clinic Constipation Score, symptom assessment, Patient Assessment of Constipation Quality of Life questionnaire, Self-Rating Anxiety Scale, and a Self-Rating Depression Scale were collected.
RESULTS


Acupuncture and EA were effective in relieving postoperative constipation. Electroacupuncture decreased constipation and improved quality of life scores.
CONCLUSION


Acupuncture and EA are novel adjuvant therapies to treat constipation.",2020,"Electroacupuncture decreased constipation and improved quality of life scores.
","['patients undergoing brain tumor resection', 'Patients Undergoing Brain Tumor Surgery', 'Patients undergoing brain tumor resection (n = 150']","['acupuncture', 'acupuncture and electroacupuncture (EA) stimulation', 'Acupuncture and EA', 'Electroacupuncture', 'Electroacupuncture Stimulation']","['relieving postoperative constipation', 'postoperative constipation', 'Rome III Diagnostic Criteria, Cleveland Clinic Constipation Score, symptom assessment, Patient Assessment of', 'constipation and improved quality of life scores', 'Constipation Quality of Life questionnaire, Self-Rating Anxiety Scale, and a Self-Rating Depression Scale', 'Postoperative Constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0948179', 'cui_str': 'Postoperative constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3165118', 'cui_str': 'Cleveland Clinic constipation score'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",150.0,0.023133,"Electroacupuncture decreased constipation and improved quality of life scores.
","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Danni Li, MSN, is Staff Nurse, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Hui Li, MSN, is Staff Nurse, Department of Spine Surgery, Second Affiliated Hospital of Harbin Medical University. Hongyan Liu, MSN, is Staff Nurse, Department of Nursing, Harbin Medical University Cancer Hospital. Hongbo Bao, PhD, is Surgeon, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Tianming Zhu, BSN, is Nurse, Department of Nursing, First Affiliated Hospital of Harbin Medical University. Jingchen Tian, BSN, is Nurse, Department of Neurosurgery, Harbin the First Hospital. Huiyan Li, MSN, is Staff Nurse, Department of Spine Surgery, Second Affiliated Hospital of Harbin Medical University. Jie Li, BSN, is Nurse, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Xinxin Guo, BSN, is Nurse, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Zhe Zhuang, PhD, is Associate Professor, Hanan Branch of Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Tianming', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Jingchen', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhuang', 'Affiliation': ''}, {'ForeName': 'Guofeng', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000531']
2921,32675585,Minimal Pain Decrease Between 2 and 4 Weeks after Nonoperative Management of a Displaced Midshaft Clavicle Fracture Is Associated with a High Risk of Symptomatic Nonunion.,"BACKGROUND


The main long-term benefit of operative treatment of displaced midshaft clavicular fractures is the reduction in nonunion risk, and as this risk is generally low, the ideal approach would be to operate only patients at high risk of nonunion. However, most current surgical decision models use baseline variables to estimate the nonunion risk, and the value of these models remains unclear. Pain in the early weeks after fracture could be potentially be an indirect measurement of fracture healing, and so it is a potential proxy variable that could lead to simpler prediction models.
QUESTIONS/PURPOSES


(1) Is pain a possible proxy variable for the development of symptomatic nonunion after nonoperative treatment of midshaft clavicular fractures? (2) How reliable is the model we created that uses pain as a proxy variable for symptomatic nonunion of nonoperatively treated clavicle fractures?
METHODS


In this secondary retrospective analysis of an earlier randomized trial, we studied prospectively collected data from 64 nonoperatively treated patients aged 18 years to 60 years. In the original randomized trial, we compared operative and nonoperative treatment of displaced midshaft clavicular fractures. In all, 150 patients were included in the study, of whom 71 received nonoperative treatment. Patients were predominantly males (75%, 48 of 64) with a mean age of 38 ± SD 12 years; most fractures were comminuted and shortened more than 1 cm. All 71 patients who were nonoperatively treated were potentially eligible for this secondary analysis; of those, 11% (8 of 71) were lost to follow-up, leaving 63 patients from the nonoperative treatment arm and one patient from the operative treatment arm (who declined surgical treatment after randomization but was followed in this group according to the intention-to-treat principle) for analysis here. Nonunion was defined as lack of callus formation, persistent fracture lines and/or sclerotic edges of the bones at the fracture site on plain radiographs at 6 months follow-up. Nonunions were regarded as symptomatic if pain, tenderness, and local crepitation were present at the fracture site. Seventeen percent (11 of 64) of patients had symptomatic nonunions. After investigating differences in early pain scores between the union and nonunion groups, we defined the VASratio as the VAS pain score at 4 weeks divided by the VAS pain score at 2 weeks. Week 2 VAS pain score was chosen as baseline after visual inspection of a linear mixed model that showed increased divergence in pain scores between union and nonunion group at 2 weeks after fracture. Week 4 was chosen as the cutoff because we wanted a reasonable time frame for the detection of pain reduction and did not want to delay surgical treatment more than necessary. Odds ratios for various risk factors were calculated using logistic regression analyses. We used a receiver operating characteristic curve analysis to identify cutoff values for the VASratio.
RESULTS


An increase in absolute pain score at 4 weeks after fracture (odds ratio 1.8 per 1 point increase [95% confidence interval 1.1 to 3.4]) was associated with an increased risk of nonunion 6 months after fracture. Likewise, we found that an increasing VASratio (OR 1.02 per 0.01 point increase [95% CI 1.002 to 1.06]) was also associated with nonunion. Receiver operating curve analysis found that the best cutoff value of VASratio was about 0.6. Patients with a VASratio above 0.6 had a relative risk of developing nonunion of 18 (95% CI 2 to 130) compared with patients with a VASratio below 0.6. Sparse-data bias could be present, as is evident from this wide confidence interval, though even at the low end of the confidence interval, the relative risk was 2, which may still improve surgical decision-making.
CONCLUSIONS


A pain score that exhibits no or minimal change from 2 to 4 weeks after nonoperative treatment of a displaced midshaft fracture of the clavicle is associated with a high risk that symptomatic nonunion will develop. Patients with no or minimal change in pain in the early weeks may be candidates for surgery to reduce the risk of symptomatic nonunion. As this was a retrospective study, with a risk of sparse-data bias, the predictive value of the VASratio needs to be further investigated in large prospective studies before clinical use.
LEVEL OF EVIDENCE


Level III, diagnostic study.",2020,An increase in absolute pain score at 4 weeks after fracture (odds ratio 1.8 per 1 point increase,"['All 71 patients who were nonoperatively treated were potentially eligible for this secondary analysis; of those, 11% (8 of 71) were lost to follow-up, leaving 63 patients from the nonoperative treatment arm and one patient from the operative treatment arm (who declined surgical treatment after randomization but was followed in this group according to the intention-to-treat principle) for analysis here', 'displaced midshaft clavicular fractures', '64 nonoperatively treated patients aged 18 years to 60 years', 'Patients were predominantly males (75%, 48 of 64) with a mean age of 38 ± SD 12 years', '150 patients were included in the study, of whom 71 received nonoperative treatment']",[],"['pain scores', 'VASratio', 'VAS pain score', 'symptomatic if pain, tenderness, and local crepitation', 'Minimal Pain Decrease', 'early pain scores', 'Pain', 'relative risk of developing nonunion', 'pain', 'absolute pain score', 'symptomatic nonunions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034642', 'cui_str': 'Respiratory crackles'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",150.0,0.130969,An increase in absolute pain score at 4 weeks after fracture (odds ratio 1.8 per 1 point increase,"[{'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Qvist', 'Affiliation': 'A. H. Qvist, Department of Orthopaedics, Aarhus University Hospital, Arhus, Denmark A. H. Qvist, T. Jakobsen, S. L. Jensen, Interdisciplinary Orthopaedics, Department of Orthopaedics, Aalborg University Hospital, Denmark A. H. Qvist, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark M. T. Væsel, Department of Orthopaedics, Viborg Regional Hospital, Viborg, Denmark C. M. Jensen, Department of Orthopaedics, Randers Regional Hospital, Randers, Denmark T. Jakobsen, S. L. Jensen, Department of Orthopaedics, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Væsel', 'Affiliation': ''}, {'ForeName': 'Carsten M', 'Initials': 'CM', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jakobsen', 'Affiliation': ''}, {'ForeName': 'Steen L', 'Initials': 'SL', 'LastName': 'Jensen', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001411']
2922,32675595,HIPEC in advanced epithelial ovarian cancer: why is there controversy?,"PURPOSE OF REVIEW


The randomized OVHIPEC study provided further evidence that adding heated intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery significantly improved recurrence-free and overall survival in stage III epithelial ovarian cancer (EOC) patients, who were ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease. Because opinions have been divided as to whether HIPEC is now a new standard of care for advanced EOC, the pros and cons of this approach are examined. A comparison with the ongoing discussion about the role of intraperitoneal chemotherapy is made.
RECENT FINDINGS


For both techniques, experience is crucial and a learning curve essential. Compared with intraperitoneal chemotherapy, intraoperative application of HIPEC provides superior distribution through the peritoneal cavity. HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
SUMMARY


Despite the ongoing debate about HIPEC, an important first step in attempting to demonstrate the efficacy of HIPEC in the first-line setting has been made with OVHIPEC. Critics have been of value to optimize future trials with HIPEC in patients with EOC.",2020,"HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
","['advanced epithelial ovarian cancer', 'patients with EOC', 'stage III epithelial ovarian cancer (EOC) patients, who were ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease']","['intraperitoneal chemotherapy, intraoperative application of HIPEC', 'HIPEC', 'heated intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery', 'intraperitoneal chemotherapy']","['quality of life and was cost-effective', 'recurrence-free and overall survival', 'adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0461488,"HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
","[{'ForeName': 'Jan B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Dam', 'Affiliation': 'Department of Gynecologic Oncology, Antwerp University Hospital, Edegem.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Department of Gynecological Oncology, Westmead Hospital.'}]",Current opinion in oncology,['10.1097/CCO.0000000000000659']
2923,32675653,Fluid-jet technique to polish the posterior capsule for phacoemulsification surgeries: efficacy and safety evaluation.,"PURPOSE


To compare the efficacy and safety of a fluid-jet technique with capsular polish in reducing residual lens fibers (RLFs) in phacoemulsification surgery.
SETTING


Single center.
DESIGN


Prospective non-randomized comparative study.
METHODS


Patients receiving phacoemulsification were included. Consecutive eligible patients alternately underwent either removal of RLFs on the posterior capsule using capsular polish after irrigation and aspiration, and before intraocular lens (IOL) implantation, or RLF removal using a fluid jet technique after IOL implantation. Posterior capsular images were used to quantify RLFs. Visual parameters were evaluated at day 1, week 1, and 1 year post-operatively. The proportion of capsule occupied by posterior capsule opacification (PCO) (area%) and incidence of protocol-driven laser posterior capsulotomy were recorded at 1 year in masked fashion.
RESULTS


Seven hundred and forty eyes were allocated to polishing (n=370) or fluid-jet (n=370). Polishing required 70.4 ± 17.5 seconds and fluid-jet 32.2 ± 9.9 seconds (P=<0.001). Compared with the polish group, capsular area occupied by RLFs in the fluid-jet group was significantly smaller (3.5% vs 0.5%,P=0.031) at the end of surgery. One day after surgery the fluid-jet group had more desirable corrected distance visual acuity, objective scattering index, and Strehl ratio (all P<0.05). PCO area percentage did not differ between groups (6.5% vs 4.5%,P=0.252) one year postoperatively, but incidence of posterior capsulotomy was lower in the fluid-jet group (3.2% vs 0.8%,P=0.019).
CONCLUSIONS


Fluid-jet removed RLFs effectively and had lower incidence of postoperative capsulotomy than capsular polishing.",2020,"One day after surgery the fluid-jet group had more desirable corrected distance visual acuity, objective scattering index, and Strehl ratio (all P<0.05).","['Patients receiving phacoemulsification were included', 'Seven hundred and forty eyes were allocated to polishing (n=370) or fluid-jet (n=370', 'Single center', 'Consecutive eligible patients alternately underwent either']","['fluid-jet technique with capsular polish', 'removal of RLFs on the posterior capsule using capsular polish after irrigation and aspiration, and before intraocular lens (IOL) implantation, or RLF removal using a fluid jet technique after IOL implantation']","['capsular area occupied by RLFs', 'proportion of capsule occupied by posterior capsule opacification (PCO) (area%) and incidence of protocol-driven laser posterior capsulotomy', 'incidence of posterior capsulotomy', 'efficacy and safety', 'PCO area percentage', 'corrected distance visual acuity, objective scattering index, and Strehl ratio', 'Visual parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0229224', 'cui_str': 'Fiber cell of lens'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0229224', 'cui_str': 'Fiber cell of lens'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3661455', 'cui_str': 'Posterior Capsulotomy, Laser'}, {'cui': 'C1735871', 'cui_str': 'Posterior lens capsulotomy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",740.0,0.0908965,"One day after surgery the fluid-jet group had more desirable corrected distance visual acuity, objective scattering index, and Strehl ratio (all P<0.05).","[{'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""From the State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University (Z. Liu, Cao, Qu, Wang, Ruan, Zheng, G. Jin, Tan, L. Jin, He, Congdon, Lin, Luo, Y. Liu), Guangzhou, Guangdong, China; 2. Center for Eye Research Australia, Ophthalmology, Department of Surgery, University of Melbourne (He), Melbourne, Australia; Translational Research for Equitable Eye Care, Center for Public Health, Royal Victoria Hospital, Queen's University Belfast (Congdon), Belfast, United Kingdom; and Orbis International (Congdon), New York, New York, United States.""}, {'ForeName': 'Qianzhong', 'Initials': 'Q', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Ruan', 'Affiliation': ''}, {'ForeName': 'Danying', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Xuhua', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Congdon', 'Affiliation': ''}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000319']
2924,32675674,Arthroscopic Repair of Large and Massive Rotator Cuff Tears: Complete Repair with Aggressive Release Compared with Partial Repair Alone at a Minimum Follow-up of 5 Years.,"BACKGROUND


The purpose of this retrospective study was to assess the clinical and radiographic outcomes of large and massive rotator tears treated with arthroscopic complete repair with a posterior interval slide compared with partial repair without a posterior interval slide at a minimum follow-up of 5 years.
METHODS


This study included 58 patients with large and massive rotator cuff tears that were unable to be treated with arthroscopic complete repair with an anterior interval slide and margin convergence alone. Each patient underwent either arthroscopic complete repair with an additional posterior interval slide and a subsequent side-to-side repair of the interval slide edge (complete-repair group) or arthroscopic partial repair with margin convergence and without the additional posterior interval slide (partial-repair group). Patient assignment to treatment group was not randomized. Clinical assessments included the visual analog scale pain score, the Subjective Shoulder Value, the American Shoulder and Elbow Surgeons score, the University of California Los Angeles shoulder score, and active range of motion. Preoperative and 6-month follow-up magnetic resonance arthrography (MRA) images were compared within and between groups.
RESULTS


At the time of the latest follow-up evaluation, both groups had significant improvements in clinical outcomes (p < 0.001). There were no significant differences in the clinical outcomes between groups. A retear was identified in 22 (88%) of the 25 patients in the complete-repair group and 28 (85%) of the 33 patients in the partial-repair group. Patients in the complete-repair group had larger retear sizes (p = 0.001) and reduced acromiohumeral intervals (p = 0.007) compared with those in the partial-repair group.
CONCLUSIONS


Although larger retear size on early postoperative MRA led to significantly reduced acromiohumeral intervals in the complete-repair group, there were no significant differences in clinical outcomes between groups during the minimum 5-year follow-up period. Therefore, it may be preferable to perform partial rotator cuff repair rather than aggressive release in large and massive rotator cuff tears to achieve complete repair.
LEVEL OF EVIDENCE


Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.",2020,"Patients in the complete-repair group had larger retear sizes (p = 0.001) and reduced acromiohumeral intervals (p = 0.007) compared with those in the partial-repair group.
","['Arthroscopic Repair of Large and Massive Rotator Cuff Tears', '58 patients with large and massive rotator cuff tears that were unable to be treated with']","['arthroscopic complete repair with an additional posterior interval slide and a subsequent side-to-side repair of the interval slide edge (complete-repair group) or arthroscopic partial repair with margin convergence and without the additional posterior interval slide (partial-repair group', 'Partial Repair Alone', 'arthroscopic complete repair with an anterior interval slide and margin convergence alone', 'arthroscopic complete repair with a posterior interval slide compared with partial repair without a posterior interval slide']","['larger retear sizes', 'visual analog scale pain score, the Subjective Shoulder Value, the American Shoulder and Elbow Surgeons score, the University of California Los Angeles shoulder score, and active range of motion', 'clinical outcomes', 'acromiohumeral intervals', 'reduced acromiohumeral intervals']","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",58.0,0.105122,"Patients in the complete-repair group had larger retear sizes (p = 0.001) and reduced acromiohumeral intervals (p = 0.007) compared with those in the partial-repair group.
","[{'ForeName': 'Jeung Yeol', 'Initials': 'JY', 'LastName': 'Jeong', 'Affiliation': 'Department of Orthopedic Surgery, Dong-Tan Sacred Heart Hospital, Hallym University School of Medicine, Hwasung, Republic of Korea.'}, {'ForeName': 'Sung-Jae', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Arthroscopy and Joint Research Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Hwan', 'Initials': 'TH', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopaedic Surgery, Arthroscopy and Joint Research Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kwang-Sik', 'Initials': 'KS', 'LastName': 'Eum', 'Affiliation': 'Department of Orthopaedic Surgery, Arthroscopy and Joint Research Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Min', 'Initials': 'YM', 'LastName': 'Chun', 'Affiliation': 'Department of Orthopaedic Surgery, Arthroscopy and Joint Research Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01014']
2925,32675750,Diabetes and CYP2C19 Polymorphism Synergistically Impair the Antiplatelet Activity of Clopidogrel Compared to Ticagrelor in PCI-Treated ACS Patients.,"Diabetes and CYP2C19 loss of function (LOF) alleles are associated with variable antiplatelet activity of the prodrug clopidogrel. We conducted a randomized trial (NCT03613857) to compare the combined and individualized effects of diabetes and CYP2C19 polymorphisms on the anti-platelet reactivity of clopidogrel vs ticagrelor in ACS patients undergoing percutaneous coronary intervention (PCI). Patients (948, 1 year follow-up 943) were randomly allocated in a 1:1 ratio to receive either clopidogrel or ticagrelor, following PCI; patients were sub-divided into eight subgroups according to the diabetes and/or CYP2C19 allele status. The study outcomes were recurrent ACS, maximum platelet aggregation (MPA),high platelet reactivity index (PRI),and incidence of major bleeding events. Diabetic patients with LOF alleles taking clopidogrel had the highest recurrent ACS rate (6 out of 33 patients) VS. all other study groups (p<0.05). However, both drugs had similar proportions of recurrent ACS in all other subgroups. Similarly, both PRI and MPA were significantly higher in the diabetic patients having LOF alleles and receiving clopidogrel VS. all other study groups (p<0.05). Nevertheless, ticagrelor caused higher rates of major bleeding VS. clopidogrel (p<0.001). PCI-treated ACS patients with diabetes and CYP2C19 LOF alleles are at a higher risk of recurrent ACS and high PRI/MPA, when treated with clopidogrel VS. ticagrelor, but almost comparable outcomes are recorded in the absence of one or the two risk factors. CLINICAL TRIAL REGISTRATION:: www.clinicaltrials.gov Identifier NCT03613857.",2020,all other study groups (p<0.05).,"['Patients (948, 1 year follow-up 943', 'patients with diabetes and CYP2C19 LOF alleles', 'ACS patients undergoing percutaneous coronary intervention (PCI', 'Diabetic patients with LOF alleles taking']","['Ticagrelor', 'ticagrelor', 'clopidogrel vs ticagrelor', 'clopidogrel or ticagrelor', 'clopidogrel', 'PCI-treated ACS', 'Clopidogrel']","['PRI and MPA', 'highest recurrent ACS rate', 'recurrent ACS', 'Diabetes and CYP2C19 loss of function (LOF) alleles', 'recurrent ACS, maximum platelet aggregation (MPA),high platelet reactivity index (PRI),and incidence of major bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",33.0,0.0150386,all other study groups (p<0.05).,"[{'ForeName': 'Mina W', 'Initials': 'MW', 'LastName': 'Mohareb', 'Affiliation': 'Department of Pharmacology & Toxicology, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'AbdElghany', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Assiut University, Assiut 71515, Egypt.'}, {'ForeName': 'Hala F', 'Initials': 'HF', 'LastName': 'Zaki', 'Affiliation': 'Department of Pharmacology & Toxicology, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt.'}, {'ForeName': 'Hanan S', 'Initials': 'HS', 'LastName': 'El-Abhar', 'Affiliation': 'Department of Pharmacology & Toxicology, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000881']
2926,32675772,Durable Suppression and Low Rate of Virologic Failure 3 Years After Switch to Dolutegravir + Rilpivirine 2-Drug Regimen: 148-Week Results From the SWORD-1 and -2 Randomized Clinical Trials.,"BACKGROUND


The SWORD trials showed that in participants who achieved virologic suppression taking 3- or 4-drug regimens, switching to the 2-drug regimen dolutegravir plus rilpivirine was non-inferior in maintaining HIV-1 RNA <50 copies/mL at the Week 48 primary endpoint. We present pooled Week 148 analysis results from both studies.
SETTING


SWORD-1: 65 centers, 13 countries; SWORD-2: 60 centers, 11 countries.
METHODS


SWORD-1 and SWORD-2 are identical, open-label, phase III studies. Participants with screening HIV-1 RNA <50 copies/mL for ≥6 months; no prior virologic failure; and no documented resistance-associated major PI, INI, NRTI, or NNRTI mutations or integrase resistance-associated substitution R263K were randomly assigned 1:1 to switch to once-daily dolutegravir 50 mg plus rilpivirine 25 mg on Day 1 (Early-Switch group) or to continue their current antiretroviral regimen and, if virologically suppressed at Week 48, switch to dolutegravir plus rilpivirine at Week 52 (Late-Switch group) until Week 148.
RESULTS


Using Snapshot algorithm at Week 148, 432/513 (84%) Early-Switch participants (148 weeks of exposure) and 428/477 (90%) Late-Switch participants (96 weeks of exposure) maintained HIV-1 RNA <50 copies/mL. Eleven participants (1%) on dolutegravir plus rilpivirine met the confirmed virologic withdrawal criterion through Week 148 (Early-Switch group, n=8; Late-Switch group, n=3) with no integrase resistance identified. NNRTI resistance-associated mutations were identified in 6 participants (<1%). Drug-related adverse events (grades 2-4) were observed in 31 (6%) Early-Switch and 16 (3%) Late-Switch participants. Significant improvements in bone biomarkers were observed. Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.",2020,"Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.","['65 centers, 13 countries; SWORD-2', 'SWORD-1', 'R263K', 'Early-Switch participants (148 weeks of exposure) and 428/477 (90', '60 centers, 11 countries']","['Dolutegravir + Rilpivirine', 'rilpivirine', 'tenofovir disoproxil fumarate', 'dolutegravir 50 mg plus rilpivirine', 'dolutegravir plus rilpivirine']","['virologic failure', 'renal biomarkers', 'Durable Suppression and Low Rate of Virologic Failure', 'virologic suppression', 'bone biomarkers', 'resistance-associated major PI, INI, NRTI, or NNRTI mutations or integrase resistance-associated substitution', 'NNRTI resistance-associated mutations']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0522656', 'cui_str': 'Sword'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C4530989', 'cui_str': 'dolutegravir and rilpivirine'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0063690', 'cui_str': 'Integrase'}]",,0.0523723,"Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch.
CONCLUSION


Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'van Wyk', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rubio', 'Affiliation': 'HIV Unit, Department of Internal Medicine, Hospital Universitario 12 de Octubre, UCM, Madrid, Spain.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Munich University Hospital, Med IV, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'East Sydney Doctors, Darlinghurst, Sydney, Australia.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Khuong-Josses', 'Affiliation': 'CHG - Hôpital Delafontaine, Saint Denis Cedex, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parks', 'Affiliation': 'Central West Clinical Research, St Louis, MO, USA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Angelis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Lesley P', 'Initials': 'LP', 'LastName': 'Kahl', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Ruolan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Maria Claudia', 'Initials': 'MC', 'LastName': 'Nascimento', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Vandermeulen', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002449']
2927,32676110,Selenium Supplementation May Decrease Thyroid Peroxidase Antibody Titer via Reducing Oxidative Stress in Euthyroid Patients with Autoimmune Thyroiditis.,"Objective


Selenium, as an antioxidant, has been implicated in the development of autoimmune thyroiditis (AIT). Many studies showed selenium supplementation could decrease thyroid autoantibodies in patients with AIT. However, the underlying mechanisms have not been well determined. Therefore, we performed a clinical study to investigate the possible mechanism of beneficial effects of selenium treatment on AIT patients.
Methods


Forty euthyroid patients with AIT were randomized into two groups. Group I was treated with 200  μ g/day selenium supplementation, and group II received a placebo over a 3-month period. Thyroid stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), antithyroglobulin antibody (TgAb), malondialdehyde (MDA), total antioxidant capacity (TAC), and superoxide dismutase (SOD) were measured before and 3 months after treatments. Additionally, twenty healthy volunteers also served as a control group for the evaluation of such parameters in basic condition.
Results


Totally, 32 patients (group I,  n  = 18; group II,  n  = 14) completed the clinical study and were incorporated into the statistics. MDA level was higher and SOD activity and TAC were lower in patients compared to healthy individuals. After 3 months, TPOAb titer significantly decreased within group I ( P  < 0.001) but did not change within group II ( P =0.001). There were also no statistically significant changes in TSH and TgAb titers within the two groups (all  P  > 0.05). Additionally, decreased MDA level (from 6.8 ± 1.3 nmol/ml to 4.9 ± 0.7 nmol/ml;  P  < 0.001) and increased TAC (from 10.0 ± 1.9 mmol/l to 12.9 ± 3.1 mmol/l;  P =0.003) and SOD activity (from 72.3 ± 10.3 U/ml to 84.3 ± 13.2 U/ml;  P =0.007) were simultaneously observed after 3 months' selenium treatment. Moreover, there was a negative correlation between TAC and TgAb/TPOAb and a positive correlation between MDA and TgAb/TPOAb in AIT patients.
Conclusions


Our findings support the hypothesis that selenium treatment could decrease TPOAb titer via enforcing the defense against oxidative stress in euthyroid patients with AIT, which may be a potential underlying mechanism.",2020,"After 3 months, TPOAb titer significantly decreased within group I ( P  < 0.001) but did not change within group II ( P =0.001).","['twenty healthy volunteers', 'Euthyroid Patients with Autoimmune Thyroiditis', 'euthyroid patients with AIT', 'patients with AIT', 'AIT patients', '32 patients (group I,  n \u2009=\u200918; group II,  n \u2009=\u200914) completed the clinical study and were incorporated into the statistics', 'Forty euthyroid patients with AIT']","['selenium supplementation', 'Selenium Supplementation', '200\u2009 μ g/day selenium supplementation', 'selenium', 'placebo']","['Thyroid stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), antithyroglobulin antibody (TgAb), malondialdehyde (MDA), total antioxidant capacity (TAC), and superoxide dismutase (SOD', 'MDA level', 'thyroid autoantibodies', 'decreased MDA level', 'TPOAb titer via enforcing the defense against oxidative stress', 'SOD activity and TAC', 'TSH and TgAb titers', 'TAC', 'SOD activity', 'TPOAb titer']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0117002', 'cui_str': 'Euthyroid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0076635', 'cui_str': 'Thyroid microsomal antibody'}, {'cui': 'C0443883', 'cui_str': 'Anti-thyroglobulin antibody'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0523376', 'cui_str': 'Anti-thyroid antibody measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}]",20.0,0.0446901,"After 3 months, TPOAb titer significantly decreased within group I ( P  < 0.001) but did not change within group II ( P =0.001).","[{'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': ""Tianjin Institute of Hepatology, Tianjin Second People's Hospital, Tianjin, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Nuclear Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Su', 'Affiliation': ""Tianjin Institute of Hepatology, Tianjin Second People's Hospital, Tianjin, China.""}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Dai', 'Affiliation': ""Tianjin Institute of Hepatology, Tianjin Second People's Hospital, Tianjin, China.""}, {'ForeName': 'Ruiguo', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Nuclear Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}]",International journal of endocrinology,['10.1155/2020/9210572']
2928,32676132,The Effects of 12-Week Physical Exercise Tapping High-level Cognitive Functions.,"The purpose of this study was to investigate the effects of physical exercise tapping high-level cognitive functions on both cognitive function and fitness in older adults. In total, 96 healthy older adults took part in the study. Participants were randomly assigned to four groups: a cognitive training group (CG), physical exercise group (PG), simultaneous cognitive training and physical exercise group (C+PG), and the healthy control group (HG; received physical exercise materials but did not participate in a cognitive or exercise programme). The outcomes were the changes in the 6-minute walk test (6MWT), timed up-and-go (TUG) test, and the computerized modified Stroop task, which included two conditions, a naming condition (nonexecutive) and an executive condition. The results showed that the dynamic balance, cardiorespiratory endurance, and physical activity levels of the PG and C+PG were significantly better than those of the HG after the 12-week intervention. The times of the TUG test in these two groups were also significantly faster than those in the HG. Additionally, the C+PG exhibited better dual-task function than the PG. Over 12 weeks, the CG, PG, and C+PG demonstrated improved performance of executive function, but only the C+PG showed a general facilitative effect on nonexecutive control. Physical exercise tapping high-level cognitive functions and cognitive training can thus improve executive function more quickly than physical exercise alone. Moreover, physical exercise tapping high-level cognitive functions showed better fitness improvement than cognitive training alone, especially in dynamic balance.",2020,"Over 12 weeks, the CG, PG, and C+PG demonstrated improved performance of executive function, but only the C+PG showed a general facilitative effect on nonexecutive control.","['96 healthy older adults took part in the study', 'older adults']","['Physical exercise tapping high-level cognitive functions and cognitive training', 'cognitive training group (CG), physical exercise group (PG), simultaneous cognitive training and physical exercise group (C+PG), and the healthy control group (HG; received physical exercise materials but did not participate in a cognitive or exercise programme', 'physical exercise tapping high-level cognitive functions', '12-Week Physical Exercise Tapping High-level Cognitive Functions']","['C+PG exhibited better dual-task function', '6-minute walk test (6MWT), timed up-and-go (TUG) test, and the computerized modified Stroop task, which included two conditions, a naming condition (nonexecutive) and an executive condition', 'executive function', 'times of the TUG test', 'performance of executive function', 'dynamic balance, cardiorespiratory endurance, and physical activity levels of the PG and C+PG']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",96.0,0.0118982,"Over 12 weeks, the CG, PG, and C+PG demonstrated improved performance of executive function, but only the C+PG showed a general facilitative effect on nonexecutive control.","[{'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Ji', 'Affiliation': 'Shanghai University of Medicine and Health Sciences, Shanghai, China1.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Physical Education College of Zhengzhou University, Zhengzhou, China2.'}, {'ForeName': 'Hongbiao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Shanghai University of Medicine and Health Sciences, Shanghai, China1.'}]",Advances in cognitive psychology,['10.5709/acp-0284-5']
2929,32676134,"Effectiveness of Acupuncture Treatment on Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized, Assessor-Blinded, Controlled Trial.","Objective


This pilot study aims to evaluate the effectiveness and safety of acupuncture in the treatment of chemotherapy-induced peripheral neuropathy (CIPN).
Methods


This study was a pilot randomized controlled trial, which was conducted with cooperation between Beijing University of Chinese Medicine (BUCM), China, and Tehran University of Medical Science (TUMS), Iran. Forty participants with CIPN were randomly assigned (1 : 1) to receive twelve sessions of acupuncture (20 minutes each session over 4 weeks) or take one 300 mg tablet of vitamin B1 and three 300 mg capsules of gabapentin per day for 4 weeks, after which both groups were followed up for 4 weeks. The primary endpoint was CIPN symptom severity measured by the Numerical Rating Scale (NRS). The secondary endpoints included sensory neuropathy grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), neurophysiological assessment of CIPN by the nerve conduction study (NCS), and the patient overall satisfaction with treatment. Safety was assessed at each visit.
Results


The NRS and NCI-CTCAE sensory neuropathy grading scales decreased significantly over time in both groups (both  P  < 0.001), with a significantly higher reduction in the acupuncture group ( P  < 0.001 and  P  = 0.03, respectively). In addition, the acupuncture group showed a higher overall satisfaction with the treatment at the end of treatment and after 4 weeks follow-up, in comparison with the vit B1 and gabapentin group ( P  = 0.01 and  P  = 0.001, respectively). The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly ( P  < 0.05), while improvement in the vit B1 and gabapentin group was not observed ( P  > 0.05).
Conclusion


Our study revealed that acupuncture, as a kind of traditional Chinese therapeutic method, is significantly effective and safe in the treatment of CIPN. Moreover, acupuncture is more effective than using vitamin B1 and gabapentin as the conventional treatment.  Trial registration.  This trial is registered with the Iranian Registry of Clinical Trials (IRCT20190615043900N1).",2020,"The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly ( P  < 0.05), while improvement in the vit B1 and gabapentin group was not observed ( P  > 0.05).
","['Chemotherapy-Induced Peripheral Neuropathy', 'Forty participants with CIPN', 'cooperation between Beijing University of Chinese Medicine (BUCM), China, and Tehran University of Medical Science']","['acupuncture', 'vitamin B1 and gabapentin', 'gabapentin', 'vit B1 and gabapentin', 'Acupuncture', 'vitamin B1 and three 300\u2009mg capsules of gabapentin']","['CIPN symptom severity measured by the Numerical Rating Scale (NRS', 'Safety', 'overall satisfaction', 'NRS and NCI-CTCAE sensory neuropathy grading scales', 'effectiveness and safety', 'sensory neuropathy grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), neurophysiological assessment of CIPN by the nerve conduction study (NCS), and the patient overall satisfaction with treatment']","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",40.0,0.246775,"The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly ( P  < 0.05), while improvement in the vit B1 and gabapentin group was not observed ( P  > 0.05).
","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Iravani', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Amir Hooman', 'Initials': 'AH', 'LastName': 'Kazemi Motlagh', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Seyede Zahra', 'Initials': 'SZ', 'LastName': 'Emami Razavi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Imam Khomeini Hospital Complex, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Shahi', 'Affiliation': 'Department of Hematology and Medical Oncology, Imam Khomeini Hospital Complex, Cancer Institute Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology and Oncology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology and Oncology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, 3 Affiliated Hospital, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Afshari Fard', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Aghili', 'Affiliation': 'Department of Radiation Oncology, Radiation Oncology Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rezaeizadeh', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Baixiao', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.'}]",Pain research & management,['10.1155/2020/2504674']
2930,32676136,Postendodontic Pain after Pulpotomy or Root Canal Treatment in Mature Teeth with Carious Pulp Exposure: A Multicenter Randomized Controlled Trial.,"This equivalence, randomized, clinical trial aimed to compare the postoperative pain of root canal therapy (RCT) with pulpotomy with mineral trioxide aggregate (PMTA) or calcium-enriched mixture (PCEM) in permanent mature teeth. In seven academic centers, 550 cariously exposed pulps were included and randomly allocated into PMTA ( n  = 188), PCEM ( n  = 194), or RCT ( n  = 168) arms. Preoperative ""Pain Intensity"" (PI) on Numerical Rating Scale and postoperative PIs until day 7 were recorded. Patients' demographic and pre-/intra-/postoperative factors/conditions were recorded/analysed. The arms were homogeneous in terms of demographics. The mean preoperative PIs were similar ( P =0.998), the mean sum PIs recorded during 10 postoperative intervals were comparable ( P =0.939), and the trend/changes in pain relief were parallel ( P =0.821) in all study arms. The incidences of preoperative moderate-severe pain in RCT, PMTA, and PCEM arms were 56.5%, 55.7%, and 56.7%, which after 24 hours considerably decreased to 13.1%, 10.6%, and 12.9%, respectively ( P =0.578). The time span of endodontic procedures was statistically different; RCT = 69.73, PMTA = 35.37, and PCEM = 33.62 minutes ( P  < 0.001). Patients with greater preoperative pain, symptomatic apical periodontitis, or presence of PDL widening suffered more pain ( P =0.002, 0.035, and 0.023, resp.); however, other pre-/intra-/postoperative factors/conditions were comparable. Pulpotomy with MTA/CEM and RCT demonstrate comparable and effective postoperative pain relief.",2020,"The mean preoperative PIs were similar ( P =0.998), the mean sum PIs recorded during 10 postoperative intervals were comparable ( P =0.939), and the trend/changes in pain relief were parallel ( P =0.821) in all study arms.","['In seven academic centers, 550 cariously exposed pulps', 'permanent mature teeth', 'Mature Teeth with Carious Pulp Exposure']","['RCT', 'root canal therapy (RCT) with pulpotomy with mineral trioxide aggregate (PMTA) or calcium-enriched mixture (PCEM', 'PMTA', 'PCEM', 'Pulpotomy or Root Canal Treatment', 'MTA/CEM and RCT']","['Postendodontic Pain', 'mean preoperative PIs', 'pain relief', 'effective postoperative pain relief', 'time span of endodontic procedures', 'mean sum PIs', 'incidences of preoperative moderate-severe pain', 'Preoperative ""Pain Intensity"" (PI) on Numerical Rating Scale and postoperative PIs', 'preoperative pain, symptomatic apical periodontitis', 'pain']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0378574', 'cui_str': '2-chloroethyl methyl sulfide'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]",,0.121584,"The mean preoperative PIs were similar ( P =0.998), the mean sum PIs recorded during 10 postoperative intervals were comparable ( P =0.939), and the trend/changes in pain relief were parallel ( P =0.821) in all study arms.","[{'ForeName': 'Mohammad Jafar', 'Initials': 'MJ', 'LastName': 'Eghbal', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haeri', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Shahravan', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Endodontic Department, Dental School, Shahed University, Tehran 1417755351, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Moazami', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mozayeni', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Eshaghali', 'Initials': 'E', 'LastName': 'Saberi', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Samiei', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Vatanpour', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Akbarzade Baghban', 'Affiliation': 'Department of Basic Sciences, Proteomics Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran 1616913111, Iran.'}, {'ForeName': 'Mahta', 'Initials': 'M', 'LastName': 'Fazlyab', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Parhizkar', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Akbarian Rad', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Bijari', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Delaram', 'Initials': 'D', 'LastName': 'Bineshmarvasti', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Davoudi', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Dehghan', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, Zahedan 9816743463, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Emami', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Farajian', 'Affiliation': 'Endodontic Department, Dental School, Shahed University, Tehran 1417755351, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Fereidooni', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Ghobadi', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Gohari', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Hashemi', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karami', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Kheirabadi', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Kozegari', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Labaf Ghasemi', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Majidi', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Parastu', 'Initials': 'P', 'LastName': 'Malekzadeh', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mehrabi', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Mehrnush', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Moradi Eslami', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Noghani', 'Affiliation': 'Endodontic Department, Dental School, Tabriz University of Medical Sciences, Tabriz 5166614713, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Omatali', 'Affiliation': 'Endodontic Department, Dental Branch, Islamic Azad University, Tehran 1946853314, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Pourhatami', 'Affiliation': 'Endodontic Department, Dental School, Shiraz University of Medical Science, Shiraz 7134814336, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Rahbani Nobar', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Rahmani', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Shafaq', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Soofiabadi', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, Kerman 7618751689, Iran.'}, {'ForeName': 'Somaye', 'Initials': 'S', 'LastName': 'Teimoori', 'Affiliation': 'Endodontic Department, Dental School, Shahed University, Tehran 1417755351, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Vatandoost', 'Affiliation': 'Endodontic Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Asgary', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1983963113, Iran.'}]",Pain research & management,['10.1155/2020/5853412']
2931,32676385,"Editorial commentary on ""Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo"".",,2020,,"['Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or']","['Placebo', 'Mirabegron']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]",[],,0.144167,,"[{'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Kamasasko', 'Affiliation': 'Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Kanya', 'Initials': 'K', 'LastName': 'Kaga', 'Affiliation': 'Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Fuse', 'Affiliation': 'Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.'}]",Translational andrology and urology,['10.21037/tau-2020-02']
2932,32676458,The Nomogram Model Predicting Overall Survival and Guiding Clinical Decision in Patients With Glioblastoma Based on the SEER Database.,"Background:  Patients with glioblastoma have a poor prognosis. We want to develop and validate nomograms for predicting overall survival in patients with glioblastoma.  Methods:  Data of patients with glioblastoma diagnosed pathologically in the SEER database from 2007 to 2016 were collected by SEER * Stat software. After eliminating invalid and missing clinical information, 3,635 patients (total group) were finally identified and randomly divided into the training group (2,183 cases) and the verification group (1,452 cases). Cox proportional risk regression model was used in the training group, the verification group and the total group to analyze the prognostic factors of patients in the training group, and then the nomogram was constructed. C-indexes and calibration curves were used to evaluate the predictive value of nomogram by internal (training group data) and external validation (verification group data).  Results:  Cox proportional risk regression model in the training group showed that age, year of diagnosis, laterality, radiation, chemotherapy were all influential factors for prognosis of patients with glioblastoma ( P  < 0.05) and were all used to construct nomogram as well. The internal and external validation results of nomogram showed that the C-index of the training group was 0.729 [95% CI was (0.715, 0.743)], and the verification group was 0.734 [95% CI was (0.718, 0.750)]. The calibration curves of both groups showed good consistency.  Conclusions:  The proposed nomogram resulted in accurate prognostic prediction for patients with glioblastoma.",2020,"The internal and external validation results of nomogram showed that the C-index of the training group was 0.729 [95% CI was (0.715, 0.743)], and the verification group was 0.734","[':  Patients with glioblastoma have a poor prognosis', 'Patients With Glioblastoma Based on the SEER Database', 'patients with glioblastoma', '3,635 patients (total group', 'patients with glioblastoma diagnosed pathologically in the SEER database from 2007 to 2016 were collected by SEER * Stat software']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242638', 'cui_str': 'Surveillance, Epidemiology, and End Results Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0037585', 'cui_str': 'Software'}]",[],[],3635.0,0.0158336,"The internal and external validation results of nomogram showed that the C-index of the training group was 0.729 [95% CI was (0.715, 0.743)], and the verification group was 0.734","[{'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Southern Marine Science and Engineering Guangdong Laboratory (Zhanjiang), The Marine Biomedical Research Institute, Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Yingya', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'School of Foreign Languages, Guangdong Medical University, Dongguan, China.'}, {'ForeName': 'Lianfang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Southern Marine Science and Engineering Guangdong Laboratory (Zhanjiang), The Marine Biomedical Research Institute, Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Southern Marine Science and Engineering Guangdong Laboratory (Zhanjiang), The Marine Biomedical Research Institute, Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Southern Marine Science and Engineering Guangdong Laboratory (Zhanjiang), The Marine Biomedical Research Institute, Guangdong Medical University, Zhanjiang, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01051']
2933,32676464,"Lactococcus lactis  Strain Plasma Improves Subjective Physical State and Presenteeism: A Randomized, Open-Label Crossover Study among Healthy Office Workers.","Maintaining employees' presenteeism is a major issue in the workplace. Simple and convenient methods to improve presenteeism are required. We investigated whether administering the lactic acid bacteria  Lactococcus lactis  strain Plasma (LC-Plasma) can improve the performance and physical condition of office workers. Subjects were randomly assigned to one of two groups: 1) an intake period (consumption of LC-Plasma-containing yogurt beverage) followed by a non-intake period, or 2) a non-intake period followed by an intake period. Each period lasted 4 weeks and there was a 4- week washout period between each. Assessment was conducted using the World Health Organization Health and Work Performance Questionnaire (HPQ), the Profile of Mood States (POMS) questionnaire and physical condition questionnaires. A total of 153 subjects were analyzed. Absolute presenteeism (as assessed by the HPQ) and vigor (as assessed by POMS) were significantly higher in the intake period than the non-intake period. The subject's physical health (as assessed by typical common cold symptoms, physical condition, sneezing or runny noses, coughing or sore throats, and lassitude) was also superior during the LC-Plasma intake period. Our results suggest that intake of LC-Plasma for 4 weeks improves work performance through reducing the risk of infection.",2020,"Assessment was conducted using the World Health Organization Health and Work Performance Questionnaire (HPQ), the Profile of Mood States (POMS) questionnaire and physical condition questionnaires.","['A total of 153 subjects were analyzed', 'Healthy Office Workers']","['lactic acid bacteria  Lactococcus lactis  strain Plasma (LC-Plasma', 'Lactococcus lactis  Strain Plasma', 'intake period (consumption of LC-Plasma-containing yogurt beverage) followed by a non-intake period, or 2) a non-intake period followed by an intake period']","['physical condition, sneezing or runny noses, coughing or sore throats, and lassitude', 'World Health Organization Health and Work Performance Questionnaire (HPQ), the Profile of Mood States (POMS) questionnaire and physical condition questionnaires', 'risk of infection', 'Absolute presenteeism', 'Subjective Physical State and Presenteeism']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1210581', 'cui_str': 'Lactobacillales'}, {'cui': 'C0038408', 'cui_str': 'Lactococcus lactis'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0086525', 'cui_str': 'Lassitude'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0597240', 'cui_str': 'State of matter'}]",153.0,0.022862,"Assessment was conducted using the World Health Organization Health and Work Performance Questionnaire (HPQ), the Profile of Mood States (POMS) questionnaire and physical condition questionnaires.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kokubo', 'Affiliation': 'Research Laboratories for Health Science and Food Technologies, Kirin Holdings Co., Ltd., Yokohama 236-0004, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Wakai', 'Affiliation': 'Health Science Department, Kirin Holdings Co., Ltd., Tokyo 164-0001, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Fujiwara', 'Affiliation': 'Health Science Department, Kirin Holdings Co., Ltd., Tokyo 164-0001, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kanauchi', 'Affiliation': 'Research Laboratories for Health Science and Food Technologies, Kirin Holdings Co., Ltd., Yokohama 236-0004, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Jounai', 'Affiliation': 'Koiwai Dairy Products Co., Ltd., Tokyo 164-0001, Japan.'}, {'ForeName': 'Hisahiro', 'Initials': 'H', 'LastName': 'Ichikawa', 'Affiliation': 'Good Conditioning Division, Yahoo Japan Corporation, Tokyo 102-8282, Japan.'}, {'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Takuma', 'Affiliation': 'Good Conditioning Division, Yahoo Japan Corporation, Tokyo 102-8282, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Kanaya', 'Affiliation': 'CAPS, Inc., Tokyo 106-0032, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Shiraoka', 'Affiliation': 'CAPS, Inc., Tokyo 106-0032, Japan.'}]",Preventive nutrition and food science,['10.3746/pnf.2020.25.2.140']
2934,32676524,Effects of denosumab versus teriparatide in glucocorticoid-induced osteoporosis patients with prior bisphosphonate treatment.,"Introduction


Osteoporosis is one of the serious adverse effects associated with glucocorticoid therapy. Although bisphosphonates have been used for glucocorticoid-induced osteoporosis (GIO), some patients have shown an inadequate response. In such cases, denosumab or teriparatide are used. However, there is no consensus on which of these two drugs is superior. We prospectively compared denosumab's and teriparatide's effects on the bone mineral density (BMD) in GIO patients with prior bisphosphonate treatment.
Materials and methods


After receiving oral bisphosphonates for ≥2 years, GIO patients with low T-score BMD (<-2.5) were switched from bisphosphonates to denosumab (n = 20) or daily teriparatide (n = 21). We measured the BMD (lumbar spine, femoral neck, and total hip) in both groups every 6 months for 24 months.
Results


At 24 months of treatment, the lumbar spine BMD increased significantly from baseline in both the denosumab and teriparatide groups (baseline vs. denosumab and teriparatide; 5.9 ± 5.6%, P < 0.001 and 7.9 ± 5.4%, P < 0.001). A significant increase in femoral neck BMD from baseline occurred only in the teriparatide group (6.6 ± 10.8%, P < 0.05); denosumab (1.5 ± 5.0%). No significant changes occurred in the total hip BMD from baseline in either group (-0.1 ± 5.6% and 3.3 ± 7.5%, respectively). There was no significant difference between the denosumab and teriparatide groups at 24 months in lumbar spine and femoral neck BMD, but was significantly higher in the teriparatide group at 12 months (P < 0.01 and P < 0.05 in the lumbar spine and femoral neck, respectively).
Conclusion


Teriparatide might have some advantages over denosumab and be a good alternative for treating GIO patients with prior bisphosphonate treatment.",2020,"There was no significant difference between the denosumab and teriparatide groups at 24 months in lumbar spine and femoral neck BMD, but was significantly higher in the teriparatide group at 12 months (P < 0.01 and P < 0.05 in the lumbar spine and femoral neck, respectively).
","['GIO patients with prior bisphosphonate treatment', 'glucocorticoid-induced osteoporosis patients with prior bisphosphonate treatment', 'for ≥2\xa0years, GIO patients with low T-score BMD (<-2.5) were switched from']","['denosumab versus teriparatide', 'teriparatide', 'bisphosphonates', 'denosumab or teriparatide', 'Teriparatide', 'bisphosphonates to denosumab', 'oral bisphosphonates']","['femoral neck BMD', 'BMD (lumbar spine, femoral neck, and total hip', 'lumbar spine and femoral neck BMD', 'bone mineral density (BMD', 'lumbar spine BMD', 'total hip BMD']","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.0187773,"There was no significant difference between the denosumab and teriparatide groups at 24 months in lumbar spine and femoral neck BMD, but was significantly higher in the teriparatide group at 12 months (P < 0.01 and P < 0.05 in the lumbar spine and femoral neck, respectively).
","[{'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Hirooka', 'Affiliation': 'Department of Rheumatology, Kindai University Nara Hospital, Nara, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Nozaki', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Rheumatology, Kindai University Nara Hospital, Nara, Japan.'}, {'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shiga', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Rheumatology, Kindai University Nara Hospital, Nara, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Funauchi', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan.'}]",Bone reports,['10.1016/j.bonr.2020.100293']
2935,32676535,Fluid type and volume reduce risk of post-ERCP pancreatitis and length of hospital stay in high-risk patients: a secondary analysis of the INDIEH trial.,"Background and study aims   Impact of intravenous fluid administration on prophylaxis against post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been rigorously evaluated among patients at high-risk for PEP.  Patients and methods   Effect of volume and type of fluid administered on PEP incidence was studied through a secondary analysis of high-risk patients who underwent endoscopic retrograde cholangopancreatography (ERCP) as a part of a randomized controlled trial in which all patients received rectal indomethacin. Periprocedural fluid was defined as fluid infused during and after ERCP.  Results   A total 960 patients were randomized during the trial, of whom 476 (49.6 %) received periprocedural fluids (mean volume = 1245 mL [± 629]). There was a trend towards a lower incidence of PEP in patients who received periprocedural fluid vs. those who did not (5.2 % vs. 8.0 %,  P   = 0.079). Among those receiving fluids, those who did not develop PEP received a higher mean volume of fluid vs. who developed PEP (1012 ± 725 mL vs. 752 ± 783 mL,  P   = 0.036). Among 174 patients (37 %) who received LR, patients who did not develop PEP received a higher mean volume of LR vs. those who developed PEP (570 ± 559 mL vs. 329 ± 356 mL,  P   = 0.006). Length of hospital stay decreased as the volume of periprocedural volume administration increased (r = 0.16,  P   < 0.001).  Conclusion   Higher fluid volume and lactated Ringer's use during the periprocedural period was associated with a decreased risk of PEP and length of hospital stay beyond rectal indomethacin in high risk patients.",2020,"Length of hospital stay decreased as the volume of periprocedural volume administration increased (r = 0.16,  P   < 0.001).  ","['high-risk patients', 'patients at high-risk for PEP', 'A total 960 patients', 'high risk patients', 'prophylaxis against post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP']","['periprocedural fluids (mean volume\u200a', 'endoscopic retrograde cholangopancreatography (ERCP', 'rectal indomethacin', 'intravenous fluid administration']","['mean volume of LR', 'volume of periprocedural volume administration', 'Length of hospital stay', 'risk of PEP and length of hospital stay', 'incidence of PEP', 'Periprocedural fluid', 'Fluid type and volume reduce risk of post-ERCP pancreatitis and length of hospital stay']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}]",960.0,0.226882,"Length of hospital stay decreased as the volume of periprocedural volume administration increased (r = 0.16,  P   < 0.001).  ","[{'ForeName': 'Rupjyoti', 'Initials': 'R', 'LastName': 'Talukdar', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Kamal', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Venkata S', 'Initials': 'VS', 'LastName': 'Akshintala', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Goud', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Lakhtakia', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Mohan K', 'Initials': 'MK', 'LastName': 'Ramchandani', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Tandan', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Rao', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Zaheer', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kalapala', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Jahangeer', 'Initials': 'J', 'LastName': 'Basha', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Rai', 'Affiliation': 'Apollo Gleneagles Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Mahesh K', 'Initials': 'MK', 'LastName': 'Goenka', 'Affiliation': 'Apollo Gleneagles Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Postgraduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kochhar', 'Affiliation': 'Postgraduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, United States.'}, {'ForeName': 'Mouen A', 'Initials': 'MA', 'LastName': 'Khashab', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'Kalloo', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'D Nageshwar', 'Initials': 'DN', 'LastName': 'Reddy', 'Affiliation': 'Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}]",Endoscopy international open,['10.1055/a-1149-1359']
2936,32678438,Value of Dynamic Contrast Perfusion MRI to Predict Early Response to Bevacizumab in Newly Diagnosed Glioblastoma: Results from ACRIN 6686 Multi-Center Trial.,"BACKGROUND


44 patients in RTOG 0825, a phase III trial of standard therapy with bevacizumab or without (placebo) in newly diagnosed glioblastoma, underwent dynamic contrast enhanced and/or dynamic susceptibility contrast MRI in ACRIN 6686. The association between early changes in relative cerebral blood volume (rCBV) and volume transfer constant (Ktrans) with overall survival (OS) was evaluated.
METHODS


MRI was performed at post-op baseline (S0), immediately before (S1), 1 day (S2), and 7 weeks after (S3) bevacizumab or placebo initiation. Mean normalized and standardized rCBV (nRCBV, sRCBV) and Ktrans were measured within contrast-enhancing lesion. Wilcoxon rank sum tests compared parameter changes from S1-S2 and S1-S3. Association with OS and progression-free survival were determined using Kaplan-Meier and log-rank tests. Treatment response for groups stratified by pretreatment nRCBV (S0, S1) was explored. The intraclass correlation coefficient and repeatability coefficient for the placebo arm (S1-S2) were used to assess repeatability.
RESULTS


27-37 datasets were evaluable per time point. Significant differences between treatment arms were found for changes in nRCBV and sRCBV from S1-S2 and S1-S3, and in Ktrans for S1-S3. Improved progression-free survival (p=0.05) but not OS (p=0.46) was observed. High pretreatment rCBV predicted improved OS for bevacizumab-treated patients. Based on the intraclass correlation coefficient, sRCBV (0.92) was more repeatable than nRCBV (0.71) and Ktrans (0.75), consistent with repeatability coefficient values.
CONCLUSIONS


Bevacizumab significantly changes rCBV but not Ktrans as early as 1 day post-treatment in newly diagnosed glioblastoma unrelated to outcomes. Improvements in clinical trial design to maximize rCBV benefit are indicated.",2020,"Significant differences between treatment arms were found for changes in nRCBV and sRCBV from S1-S2 and S1-S3, and in Ktrans for S1-S3.","['Newly Diagnosed Glioblastoma', '44 patients in RTOG 0825, a phase III trial of standard therapy with']","['bevacizumab or without (placebo', 'bevacizumab or placebo initiation', 'bevacizumab', 'Bevacizumab']","['Association with OS and progression-free survival', 'nRCBV and sRCBV', 'OS', 'relative cerebral blood volume (rCBV) and volume transfer constant (Ktrans) with overall survival (OS', 'Mean normalized and standardized rCBV (nRCBV, sRCBV) and Ktrans', 'Improved progression-free survival']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C4277714', 'cui_str': 'Cerebral Blood Volume'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.114369,"Significant differences between treatment arms were found for changes in nRCBV and sRCBV from S1-S2 and S1-S3, and in Ktrans for S1-S3.","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Schmainda', 'Affiliation': 'Department of Biophysics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Prah', 'Affiliation': 'Department of Biophysics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Marques', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Merck\xa0Research Laboratories, Kenilworth, NJ, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Barboriak', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jerrold L', 'Initials': 'JL', 'LastName': 'Boxerman', 'Affiliation': 'Department of Diagnostic Imaging, Rhode Island Hospital, and Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Neuro-oncology,['10.1093/neuonc/noaa167']
2937,32678452,Effect of Inhaled Cannabis for Pain in Adults With Sickle Cell Disease: A Randomized Clinical Trial.,"Importance


Sickle cell disease (SCD) is characterized by chronic pain and episodic acute pain caused by vasoocclusive crises, often requiring high doses of opioids for prolonged periods. In humanized mouse models of SCD, a synthetic cannabinoid has been found to attenuate both chronic and acute hyperalgesia. The effect of cannabis on chronic pain in adults with SCD is unknown.
Objective


To determine whether inhaled cannabis is more effective than inhaled placebo in relieving chronic pain in adults with SCD.
Design, Setting, and Participants


This pilot randomized clinical trial included participants with SCD with chronic pain admitted to a single inpatient clinical research center for 2 separate 5-day stays from August 2014 to April 2017. Participants inhaled either vaporized cannabis (4.4% Δ-9-tetrahydrocannabinol to 4.9% cannabidiol) 3 times daily or vaporized placebo cannabis. Pain and pain interference ratings using the Brief Pain Inventory were assessed throughout each 5-day period. Participants with SCD and chronic pain on stable analgesics were eligible to enroll. A total of 90 participants were assessed for eligibility; 56 participants were deemed ineligible, and 34 participants were enrolled. Of these, 7 participants dropped out before randomization. Of 27 randomized participants, 23 completed both treatment arms of the crossover study and were included in the final per protocol analysis. Data analysis was completed in June 2019, with the sensitivity analysis conducted in April 2020.
Interventions


Inhalation of vaporized cannabis plant (4.4% Δ-9-tetrahydrocannbinol to 4.9% cannabidiol) or placebo cannabis plant using a vaporizer 3 times daily for 5 days.
Main Outcomes and Measures


Daily pain assessed with visual analog scale and Brief Pain Inventory.
Results


A total of 23 participants (mean [SD] age, 37.6 [11.4] years; 13 [56%] women) completed the trial. The mean (SD) difference in pain rating assessment between the cannabis and placebo groups was -5.3 (8.1) for day 1, -10.9 (7.0) for day 2, -16.5 (9.2) for day 3, -8.9 (6.7) for day 4, and -8.2 (8.1) for day 5; however, none of these differences were statistically significant. There was no statistically significant mean (SD) difference in pain interference ratings between cannabis and placebo between days 1 and 5 for interference in general activities (day 1: 0.27 [0.35]; day 5: -1.0 [0.5]), walking (day 1: 0.14 [0.73]; day 5: -0.87 [0.63]), sleep (day 1: 0.59 [0.74]; day 5: -1.3 [0.8]), or enjoyment (day 1: 0.23 [0.69]; day 5: -0.91 [0.48]), but there was a statistically significant mean (SD) difference in decrease in interference with mood (day 1: 0.96 [0.59]; day 5: -1.4 [0.6]; P = .02). No differences in treatment-related adverse effects were observed. Use of concomitant opioids was similar during both treatment periods.
Conclusions and Relevance


This randomized clinical trial found that, compared with vaporized placebo, vaporized cannabis did not statistically significantly reduce pain and associated symptoms, except interference in mood, in patients with SCD with chronic pain.
Trial Registration


ClinicalTrials.gov Identifier: NCT01771731.",2020,"There was no statistically significant mean (SD) difference in pain interference ratings between cannabis and placebo between days 1 and 5 for interference in general activities (day 1: 0.27 [0.35]; day 5: -1.0 [0.5]), walking (day 1: 0.14 [0.73];","['Adults With Sickle Cell Disease', 'A total of 90 participants were assessed for eligibility; 56 participants were deemed ineligible, and 34 participants were enrolled', '23 participants (mean [SD] age, 37.6 [11.4] years; 13 [56%] women) completed the trial', '27 randomized participants, 23 completed both treatment arms of the crossover study and were included in the final per protocol analysis', 'patients with SCD with chronic pain', 'Participants with SCD and chronic pain on stable analgesics were eligible to enroll', 'participants with SCD with chronic pain admitted to a single inpatient clinical research center for 2 separate 5-day stays from August 2014 to April 2017', 'adults with SCD']","['vaporized cannabis plant (4.4% Δ-9-tetrahydrocannbinol to 4.9% cannabidiol) or placebo cannabis plant', 'vaporized placebo', 'Inhaled Cannabis', 'vaporized cannabis (4.4% Δ-9-tetrahydrocannabinol to 4.9% cannabidiol) 3 times daily or vaporized placebo cannabis', 'cannabis', 'placebo']","['adverse effects', 'pain and associated symptoms', 'mean (SD) difference in pain rating assessment', 'chronic pain', 'Pain and pain interference ratings', 'pain interference ratings', 'sleep', 'Main Outcomes and Measures\n\n\nDaily pain assessed with visual analog scale and Brief Pain Inventory']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",90.0,0.730869,"There was no statistically significant mean (SD) difference in pain interference ratings between cannabis and placebo between days 1 and 5 for interference in general activities (day 1: 0.27 [0.35]; day 5: -1.0 [0.5]), walking (day 1: 0.14 [0.73];","[{'ForeName': 'Donald I', 'Initials': 'DI', 'LastName': 'Abrams', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Zuckerberg San Francisco General Hospital, University of California, San Francisco.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Couey', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Zuckerberg San Francisco General Hospital, University of California, San Francisco.'}, {'ForeName': 'Niharika', 'Initials': 'N', 'LastName': 'Dixit', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Zuckerberg San Francisco General Hospital, University of California, San Francisco.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Sagi', 'Affiliation': 'Vascular Biology Center, Division of Hematology-Oncology-Transplantation, Department of Medicine, University of Minnesota Medical School, Minneapolis.'}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Hagar', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Vichinsky', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Kelly', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Zuckerberg San Francisco General Hospital, University of California, San Francisco.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'Kalpna', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Vascular Biology Center, Division of Hematology-Oncology-Transplantation, Department of Medicine, University of Minnesota Medical School, Minneapolis.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.10874']
2938,32678484,Emotional mechanisms and format effects of motivational questions for blood donation.,"Prior studies suggest that responding to online motivational questions increases blood donation intention. The present studies were designed to extend these findings by (a) exploring the impact of methodologic variations in the content and order of administration of specific questions on donation intention and (b) examining anticipated positive and negative emotional reactions as potential mediators.
STUDY DESIGN AND METHODS


In the first study, 4709 respondents (51.2% female; mean ± SD age, 38.4 ± 12.1 years) were randomly assigned to one of four motivational questions or a no-question control. In the second study, 5291 respondents (52.7% female; mean ± SD age, 37.3 ± 11.9 years) were randomly assigned to one of six motivational questions or a no-question control. In both studies, the motivational questions were followed by measures of donation intention, anticipated warm glow, and anticipated regret.
RESULTS


In Study 1, three of the four questions were associated with higher donation intentions, with anticipated warm glow being a potential partial mediator for two of the questions. In Study 2, five of the six questions were associated with higher donation intentions, with anticipated warm glow and anticipated regret being potential partial mediators for three of the questions. These effects were largely consistent among donors and nondonors.
CONCLUSION


These studies expand our understanding of the association between particular motivational questions and donation intentions and provide preliminary support for the notion that specific questions may influence donation intention by increasing anticipated positive and negative emotional reactions to the thought of giving or not giving, respectively.",2020,"In Study 1, three of the four questions were associated with higher donation intentions, with anticipated warm glow being a potential partial mediator for two of the questions.","['5291 respondents (52.7% female; mean ±\u2009SD age, 37.3 ±\u200911.9\u2009years', '4709 respondents (51.2% female; mean\u2009±\u2009SD age, 38.4 ±\u200912.1\u2009years']","['six motivational questions or a no-question control', 'motivational questions or a no-question control']","['blood donation intention', 'higher donation intentions']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}]",5291.0,0.0203448,"In Study 1, three of the four questions were associated with higher donation intentions, with anticipated warm glow being a potential partial mediator for two of the questions.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Lina K', 'Initials': 'LK', 'LastName': 'Himawan', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jeitani', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Williams', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}]",Transfusion,['10.1111/trf.15942']
2939,32678485,Endoscopic trans gluteal minimal-invasive approach for nerve liberation (ENTRAMI technique) in case of pudendal and/or cluneal neuralgia by entrapment: One-year follow-up.,"BACKGROUND


Chronic neuropathic perineal pain syndrome is a collective term that encompasses several diagnoses. In patients where the neuropathic pain syndrome is caused by pudendal or cluneal nerve entrapment, surgical release can be proposed if other measures have failed. The aim of this study is to evaluate the clinical outcome of patients suffering from pudendal and/or cluneal nerve entrapment at 1 year after this minimal invasive surgery, which is based on the open trans gluteal approach who has proven its efficacy compared to medical treatment in a randomized control trial.
METHODS


Patients eligible for inclusion had chronic perineal neuropathic pain for at least 3 months in the area served by the pudendal and/or cluneal nerve, refractory to conservative measurements. Patients met all five of the Nantes criteria.
RESULTS


Fifteen patients underwent the ENTRAMI technique. At 1 year after surgery, overall reduction of the average maximal Numeric Pain rating Scale (NPRS-score) was from 9 (range, 7-10) at baseline to 5 (range, 0-10; P-value <.05). At 1 year 73% of patients declared to have a ""good treatment response"" (patient global impression of change [PGIC] >30%) and optimal treatment response (PGIC ≥90%) was found in 40% (P-value <.05). No complications were recorded.
CONCLUSION


This study clearly shows that the technique is feasible with promising long-term results in a difficult to manage patient group.",2020,"At 1 year after surgery, overall reduction of the average maximal Numeric Pain rating Scale (NPRS-score) was from 9 (range, 7-10) at baseline to 5 (range, 0-10; P-value <.05).","['Patients met all five of the Nantes criteria', 'patients suffering from pudendal and/or cluneal nerve entrapment at 1 year after this minimal invasive surgery', 'Fifteen patients underwent the ENTRAMI technique', 'Chronic neuropathic perineal pain syndrome', 'case of pudendal and/or cluneal neuralgia by entrapment', 'Patients eligible for inclusion had chronic perineal neuropathic pain for at least 3 months in the area served by the pudendal and/or cluneal nerve, refractory to conservative measurements']",['Endoscopic trans gluteal minimal-invasive approach'],['average maximal Numeric Pain rating Scale (NPRS-score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917811', 'cui_str': 'Nerve Entrapment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1285497', 'cui_str': 'Entrapment'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0427779,"At 1 year after surgery, overall reduction of the average maximal Numeric Pain rating Scale (NPRS-score) was from 9 (range, 7-10) at baseline to 5 (range, 0-10; P-value <.05).","[{'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Jottard', 'Affiliation': 'Department of Surgery, Brugmann Hospital, Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bruyninx', 'Affiliation': 'Department of Surgery, Brugmann Hospital, Brussels, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bonnet', 'Affiliation': 'Department of Urology and Department of Anatomy, CHU Sart-Tilman, Liège, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'De Wachter', 'Affiliation': 'Department of Urology, Antwerp University Hospital, Edegem, Belgium.'}]",Neurourology and urodynamics,['10.1002/nau.24462']
2940,32678489,The effectiveness of an indicated prevention programme for substance use in individuals with mild intellectual disabilities and borderline intellectual functioning: results of a quasi-experimental study.,"AIMS


To assess the effectiveness of Take it personal!, a prevention programme for individuals with mild intellectual disabilities and borderline intellectual functioning (MID-BIF) and substance use (SU). The prevention programme aims to reduce SU (alcohol, cannabis, and illicit drugs) among experimental to problematic substance users.
DESIGN


A quasi-experimental design with two arms and a 3-month follow-up.
SETTING


Adolescents were recruited from 14 treatment centres in the Netherlands specialised in offering intra- and extramural care for people with MID-BIF and behavioural problems.
PARTICIPANTS


Data were collected from 66 individuals with MID-BIF assigned either to the intervention condition (n=34) or to the control condition (n=32).
INTERVENTIONS


Take it personal! was designed to target four personality traits: sensation seeking, impulsive behaviour, anxiety sensitivity, and negative thinking. For each of these profiles, interventions were developed that were structurally the same but contained different personality-specific materials, games, and exercises. The control group received care as usual.
MEASUREMENTS


Primary outcomes at 3-month follow-up were frequency of SU, severity of SU and binge drinking.
FINDINGS


Results showed intervention effects for SU frequency (F(1, 50.43) = 9.27, p = 0.004) and binge drinking (F(1, 48.02) = 8.63, p = 0.005), but not for severity of SU (F(1, 42.09) = 2.20, p = 0.145).
CONCLUSIONS


A prevention programme to reduce substance use among experimental to problematic users with mild intellectual disabilities and borderline intellectual functioning helped participants decrease substance use frequency and binge drinking.",2020,"The prevention programme aims to reduce SU (alcohol, cannabis, and illicit drugs) among experimental to problematic substance users.
","['individuals with mild intellectual disabilities and borderline intellectual functioning', 'Data were collected from 66 individuals with MID-BIF assigned either to the intervention condition (n=34) or to the control condition (n=32', 'Adolescents were recruited from 14 treatment centres in the Netherlands specialised in offering intra- and extramural care for people with MID-BIF and behavioural problems', 'individuals with mild intellectual disabilities and borderline intellectual functioning (MID-BIF) and substance use (SU']","['indicated prevention programme', 'SU (alcohol, cannabis, and illicit drugs']","['binge drinking', 'frequency of SU, severity of SU and binge drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026106', 'cui_str': 'Mild intellectual disability'}, {'cui': 'C0006009', 'cui_str': 'Borderline intellectual disability'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]","[{'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",66.0,0.0308177,"The prevention programme aims to reduce SU (alcohol, cannabis, and illicit drugs) among experimental to problematic substance users.
","[{'ForeName': 'Esmée P', 'Initials': 'EP', 'LastName': 'Schijven', 'Affiliation': 'Research & Development, Pluryn, P.O. Box 53, 6500AB, Nijmegen, the Netherlands.'}, {'ForeName': 'Daan H G', 'Initials': 'DHG', 'LastName': 'Hulsmans', 'Affiliation': 'Research & Development, Pluryn, P.O. Box 53, 6500AB, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanneke E L', 'Initials': 'JEL', 'LastName': 'VanDerNagel', 'Affiliation': 'Tactus, Centre for Addiction and Intellectual Disability (CAID), P.O. Box 154, 7400 AD, Deventer, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lammers', 'Affiliation': 'Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Utrecht, the Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Research & Development, Pluryn, P.O. Box 53, 6500AB, Nijmegen, the Netherlands.'}, {'ForeName': 'Evelien A P', 'Initials': 'EAP', 'LastName': 'Poelen', 'Affiliation': 'Research & Development, Pluryn, P.O. Box 53, 6500AB, Nijmegen, the Netherlands.'}]","Addiction (Abingdon, England)",['10.1111/add.15156']
2941,32676205,The Effectiveness of First-Generation iStent Microbypass Implantation Depends on Initial Intraocular Pressure: 24-Month Follow-Up-Prospective Clinical Trial.,"Background


Evaluation of efficacy of the iStent trabecular bypass implant in reducing intraocular pressure (IOP) depending on the value pretreatment IOP and number of medications used before surgery in patients with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG) and coexisting cataract.
Methods


A prospective, uncontrolled, interventional case series. 72 patients, on a mean age of 72.42 ± 9.17, were divided into two groups depending on baseline IOP: group I < 26 mmHg and group II ≥ 26 mmHg. All subjects underwent  ab interno  implantation of a single iStent together with cataract surgery. Best-corrected visual acuity (BCVA), IOP, number of antiglaucoma medications, visual field, and number and type of complications were examined before and after surgery. Postoperative patients were followed up at 1, 7, and 30 days and 3, 6, 12, and 24 months. All the patients were washed out preoperatively as well as postoperatively.
Results


The mean observation time was 20 months. The mean preoperative IOP was 21.03 ± 1.44 mmHg in group I and reduced to mean 15.60 ± 2.12 mmHg after operation. In group II, mean IOP reduced from 26.00 ± 0.00 to 18.56 ± 1.81 ( p =0.003). Mean glaucoma medications decreased from 1.35 ± 0.65 to 0.29 ± 0.52 in group I ( p  < 0.001) and from 2.89 ± 1.18 to 1.33 ± 1.50 in group II ( p  < 0.001). At 24 months, medication reduction was significantly greater in group I than group II ( p =0.026).
Conclusions


Combined cataract surgery with implantation of iStent seems to be an effective procedure in patients with mild-to-moderate open-angle glaucoma and cataract. In patients with baseline IOP < 26 mmHg, surgery reduced IOP and medication use significantly declined to 2 years, with greater reductions achieved versus patients with baseline IOP ≥ 26 mmHg. This trial is registered with NCT03807869.",2020,"At 24 months, medication reduction was significantly greater in group","['patients with mild-to-moderate open-angle glaucoma and cataract', '72 patients, on a mean age of 72.42\u2009±\u20099.17, were divided into two groups depending on baseline IOP', 'patients with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG) and coexisting cataract']","['iStent trabecular bypass implant', 'ab interno  implantation of a single iStent together with cataract surgery', 'BCVA', 'First-Generation iStent Microbypass Implantation']","['Best-corrected visual acuity ', 'medication reduction', ' IOP, number of antiglaucoma medications, visual field, and number and type of complications', 'mean IOP', 'mean preoperative IOP', 'Mean glaucoma medications', 'intraocular pressure (IOP', 'mean observation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",72.0,0.0360451,"At 24 months, medication reduction was significantly greater in group","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Konopińska', 'Affiliation': 'Department of Ophthalmology, Medical University of Białystok, M. Sklodowskiej-Curie 24A STR, 15-276 Białystok, Poland.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Kozera', 'Affiliation': 'Department of Ophthalmology, Military Institute of Medicine, Szaserów 128 STR, 04-141 Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Kraśnicki', 'Affiliation': 'Department of Ophthalmology, Medical University of Białystok, M. Sklodowskiej-Curie 24A STR, 15-276 Białystok, Poland.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Mariak', 'Affiliation': 'Department of Ophthalmology, Medical University of Białystok, M. Sklodowskiej-Curie 24A STR, 15-276 Białystok, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Rękas', 'Affiliation': 'Department of Ophthalmology, Military Institute of Medicine, Szaserów 128 STR, 04-141 Warsaw, Poland.'}]",Journal of ophthalmology,['10.1155/2020/8164703']
2942,32676276,Efficacy and Safety of Rivaroxaban versus Warfarin for the Treatment of Acute Pulmonary Embolism: A Real-World Study.,"Background


Pulmonary embolism (PE) is a life-threatening disease. Target-specific anticoagulant rivaroxaban is a direct factor Xa inhibitor that can be safely used without laboratory monitoring.
Objective


To investigate the efficacy and safety of rivaroxaban versus warfarin for the treatment of acute pulmonary thromboembolism in real-world clinical practice.
Method


This was a semiretrospective, semiprospective, and real-world trial involving 128 patients with acute symptomatic pulmonary embolism with or without active tumor or frailty. We compared rivaroxaban to the standard therapy consisting of low-molecular-weight heparin combined with warfarin. The primary efficacy outcome was absorption of thrombus. The principal safety outcome was bleeding episode.
Results


There was no significant difference in thrombus absorption between rivaroxaban and standard therapy after 3-month treatment ( P  = 0.798, 95% confidence interval (CI) 0.686 to 1.336) or more than 6-month treatment ( P  = 0.534, 95% confidence interval (CI) 0.795 to 1.556). There was no decline in efficacy (including computed tomographic pulmonary angiography and recurrence) when the rivaroxaban dose was reduced to 10 mg once daily after 3 months of administration. The ratio of patients without bleeding was 48.84% for rivaroxaban and 19.05% for standard therapy ( P  = 0.001). There was no significant difference in rivaroxaban monotherapy subgroups (including frail patients, tumor patients, and thrombolysis or nonthrombolysis at intermediate-high-risk patients).
Conclusion


In this real-world study, the efficacy and safety of rivaroxaban alone was not different to standard therapy for pulmonary emboli absorption. With an extension in treatment duration, the rivaroxaban regimen had a higher efficacy and safety than standard therapy and there was no decline in treatment efficacy when the rivaroxaban dose was reduced to 10 mg once daily.",2020,"There was no significant difference in thrombus absorption between rivaroxaban and standard therapy after 3-month treatment ( P  = 0.798, 95% confidence interval (CI) 0.686 to 1.336) or more than 6-month treatment ( P  = 0.534, 95% confidence interval (CI) 0.795 to 1.556).","['Acute Pulmonary Embolism', '128 patients with acute symptomatic pulmonary embolism with or without active tumor or frailty']","['Rivaroxaban versus Warfarin', 'warfarin', 'heparin combined with warfarin', 'rivaroxaban', 'Xa inhibitor']","['Efficacy and Safety', 'bleeding episode', 'treatment efficacy', 'ratio of patients without bleeding', 'absorption of thrombus', 'efficacy (including computed tomographic pulmonary angiography and recurrence', 'efficacy and safety', 'thrombus absorption']","[{'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",128.0,0.111639,"There was no significant difference in thrombus absorption between rivaroxaban and standard therapy after 3-month treatment ( P  = 0.798, 95% confidence interval (CI) 0.686 to 1.336) or more than 6-month treatment ( P  = 0.534, 95% confidence interval (CI) 0.795 to 1.556).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Xinni', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Nuofu', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Yanghang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510120, China.'}]",Analytical cellular pathology (Amsterdam),['10.1155/2020/6813492']
2943,32676284,Comparison of Autocross-Linked Hyaluronic Acid Gel and Intrauterine Device for Preventing Intrauterine Adhesions in Infertile Patients: A Randomized Clinical Trial.,"Objectives


The objective of this study is to evaluate the efficacy of autocross-linked hyaluronic acid (HA) compared with intrauterine device (IUD) for preventing intrauterine adhesions (IUAs) in infertile patients after hysteroscopic adhesiolysis.
Materials and Methods


A randomized clinical trial (ChiCTR-IOR-16007746). Upon completion of adhesiolysis, 3 ml of HA gel was placed into the uterine cavity in Group A; 3 ml of HA gel and an IUD were placed in Group B; and only an IUD was placed in Group C. A second hysteroscopic examination was performed in all patients at approximately 1 month postoperatively for the evaluation of IUA. The primary outcome measure was the effective rate of IUA prevention based on the American Fertility Society (AFS) scoring system.
Results


Eighty-nine women were randomly distributed into two groups for intention to treat with 30 patients in Group A, 24 patients in Group B, and 35 patients in Group C. Patients were scored and stratified into three degrees and were enrolled using the simple random sampling method. The three groups were well balanced. There were no significant differences in age, endometrial thickness, the previous number of pregnancy, and the distribution of adhesion categories across mild, moderate, and severe between the three groups. The effective rate of IUA prevention, the AFS score after therapy, and the percentage improvements of Chinese score and AFS score before and after surgery were statistically significant difference between Groups A and C. The clinical pregnancy rate in Group A was higher than those in Groups B and C, but the difference was not statistically significant.
Conclusion


HA gel has an advantage over an IUD in reducing IUA recurrence and decreasing adhesions.",2020,"There were no significant differences in age, endometrial thickness, the previous number of pregnancy, and the distribution of adhesion categories across mild, moderate, and severe between the three groups.","['Infertile Patients', 'infertile patients after hysteroscopic adhesiolysis', 'Eighty-nine women']","['Autocross-Linked Hyaluronic Acid Gel and Intrauterine Device', 'autocross-linked hyaluronic acid (HA', 'intrauterine device (IUD']","['Intrauterine Adhesions', 'clinical pregnancy rate', 'IUA recurrence', 'effective rate of IUA prevention based on the American Fertility Society (AFS) scoring system', 'effective rate of IUA prevention, the AFS score', 'Chinese score and AFS score', 'age, endometrial thickness, the previous number of pregnancy, and the distribution of adhesion categories across mild, moderate, and severe']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",89.0,0.113076,"There were no significant differences in age, endometrial thickness, the previous number of pregnancy, and the distribution of adhesion categories across mild, moderate, and severe between the three groups.","[{'ForeName': 'Yu-Qing', 'Initials': 'YQ', 'LastName': 'Wang', 'Affiliation': 'School of medicine, Shandong University, Shandong, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Song', 'Affiliation': 'Center for Reproductive Medicine, Reproductive Hospital Affiliated to Shandong University, Shandong, China.'}, {'ForeName': 'She-Ling', 'Initials': 'SL', 'LastName': 'Wu', 'Affiliation': 'Center for Reproductive Medicine, Reproductive Hospital Affiliated to Shandong University, Shandong, China.'}, {'ForeName': 'Yu-Zhen', 'Initials': 'YZ', 'LastName': 'Huang', 'Affiliation': 'Center for Reproductive Medicine, Reproductive Hospital Affiliated to Shandong University, Shandong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'School of medicine, Shandong University, Shandong, China.'}, {'ForeName': 'Chang-Zhong', 'Initials': 'CZ', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}]",Gynecology and minimally invasive therapy,['10.4103/GMIT.GMIT_103_19']
2944,32676310,"Open-label, multicenter, randomized phase II study on docetaxel plus bevacizumab or pemetrexed plus bevacizumab for treatment of elderly (aged ≥75 years) patients with previously untreated advanced non-squamous non-small cell lung cancer: TORG1323.","Background


The effectiveness of bevacizumab monotherapy in elderly patients with non-squamous non-small cell lung cancer (NSCLC) is unclear. The efficacy of the combinations for elderly patients was explored.
Methods


Untreated patients (≥75 years; performance status 0-1) with stage IIIB, IV, or recurrent non-squamous NSCLC were included. Patients with epidermal growth factor receptor ( EGFR ) mutation or anaplastic lymphoma kinase ( ALK ) gene rearrangements were eligible even if they received tyrosine kinase inhibitors. Patients were randomized 1:1 to receive docetaxel (50 mg/m 2 ) (DB) or pemetrexed (500 mg/m 2 ) (PB) with bevacizumab (15 m/kg). The primary endpoint was progression-free survival (PFS). Treatment was administered every 3 weeks until disease progression or unacceptable toxicity.
Results


Overall, 103 patients (DB: n=51; PB: n=52) were enrolled. In the DB and PB arms, median ages [range] were 78 [75-88] and 79 [75-94] years, respectively; median PFS were 6.1 and 4.6 months, respectively [hazard ratio (HR), 1.03; 95% confidence interval (CI), 0.66-1.61]; and response rates were 43%, and 40%, respectively (P=0.840). Grade ≥3 leukopenia, neutropenia, and fatigue incidences were significantly higher in the DB arm. Febrile neutropenia incidence did not differ significantly (16%  vs . 12%, P=0.578). One patient in the PB arm died from a ruptured abdominal aortic aneurysm. Quality of life (QoL) analysis revealed less deterioration in the PB arm.
Conclusions


In previously untreated elderly patients with non-squamous NSCLC, PB shows feasibility, better QoL, and promising efficacy in terms of PFS, and an objective response rate for further analysis (UMIN000012786).",2020,Febrile neutropenia incidence did not differ significantly (16%  vs .,"['Patients with epidermal growth factor receptor ( EGFR ) mutation or anaplastic lymphoma kinase', 'n=51; PB: n=52) were enrolled', 'elderly (aged ≥75 years) patients with previously untreated advanced non-squamous non-small cell lung cancer', 'elderly patients with non-squamous non-small cell lung cancer (NSCLC', '103 patients (DB', 'elderly patients', 'Methods\n\n\nUntreated patients (≥75 years; performance status 0-1) with stage IIIB, IV, or recurrent non-squamous NSCLC were included']","['docetaxel', 'docetaxel plus bevacizumab or pemetrexed plus bevacizumab', 'pemetrexed', 'bevacizumab', 'bevacizumab monotherapy']","['Febrile neutropenia incidence', 'Grade ≥3 leukopenia, neutropenia, and fatigue incidences', 'response rates', 'Quality of life (QoL', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",52.0,0.0666386,Febrile neutropenia incidence did not differ significantly (16%  vs .,"[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kozuki', 'Affiliation': 'Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hataji', 'Affiliation': 'Department of Respiratory Medicine, Matsusaka Municipal Hospital, Matsusaka, Mie, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsunezuka', 'Affiliation': 'Department of General Thoracic Surgery, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Seki', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, Japan Community Health Care Organization Hokkaido Hospital, Toyohira-ku, Sapporo, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Respiratory Medicine, Okayama Rosai Hospital, Minami-ku, Okayama-shi, Okayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Bessho', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Kita-ku, Okayama-shi, Okayama, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Takamura', 'Affiliation': 'Department of Respiratory Medicine, Obihiro Kosei General Hospital, Obihiro-shi, Hokkaido, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Respiratory Medicine, Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Satouchi', 'Affiliation': 'Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Hyogo, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Takehito', 'Initials': 'T', 'LastName': 'Shukuya', 'Affiliation': 'Department of Respiratory Medicine, Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Yamashita', 'Affiliation': 'Clinical Research Center, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Kanagawa, Japan.""}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Shinkai', 'Affiliation': 'Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Translational lung cancer research,['10.21037/tlcr.2020.03.29']
2945,32676536,Improved detection of colorectal adenomas by high-quality colon cleansing.,"Background and study aims   Reliable adenoma detection requires ""adequate"" bowel preparation. The adenoma detection rate (ADR) was assessed in patients with high-quality (stool-free) cleansing versus adequate cleansing.  Patients and methods   This study was a post-hoc combined analysis of three randomized trials individually powered for cleansing quality assessment. Treatment-independent ADR was assessed versus colon cleansing quality by central readers using the Harefield Cleansing Scale (HCS) and the Boston Bowel Preparation Scale (BBPS). The number needed to treat (NNT) to find an additional patient with at least one adenoma was calculated for high-quality versus adequate-quality cleansing.  Results   A total of 1749 patients were included. ADR increased with high-quality versus adequate-quality cleansing: HCS grade A versus B, 39 % (94/242) versus 27 % (336/1229); NNT = 8.7;  P   < 0.001. ADR also increased with high-quality versus uniform adequate segmental cleansing scores: HCS grade A versus uniform segmental scores 2, 39 % (94/242) versus 26 % (97/379); NNT = 7.5;  P   < 0.001. ADR increased with top-quality versus adequate segmental cleansing scores: HCS uniform segmental scores 4 versus 2, 54 % (21/39) versus 26 % (97/379); NNT = 3.6;  P   < 0.001. ADR increased with BBPS 9 versus 6, 43 % (71/166) versus 26 % (247/950); NNT = 6.0;  P   < 0.001. Right colon ADR increased with top-quality versus adequate cleansing: HCS 4 versus 2, 20 % (25/122) versus 11 % (121/1117); NNT = 10.4;  P   < 0.001 and BBPS 3 versus 2, 15 % (42/284) versus 11 % (130/1192); NNT = 25.8;  P   = 0.033.  Conclusions   High-quality colon cleansing improves adenoma detection, and it should be a priority for bowel preparations for colonoscopy.",2020,"ADR increased with top-quality versus adequate segmental cleansing scores: HCS uniform segmental scores 4 versus 2, 54 % (21/39) versus 26 % (97/379); NNT = 3.6;  P   < 0.001. ",['A total of 1749 patients were included'],[],"['Harefield Cleansing Scale (HCS) and the Boston Bowel Preparation Scale (BBPS', 'ADR increased with BBPS', 'adenoma detection rate (ADR', 'Right colon ADR']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}]",1749.0,0.0741638,"ADR increased with top-quality versus adequate segmental cleansing scores: HCS uniform segmental scores 4 versus 2, 54 % (21/39) versus 26 % (97/379); NNT = 3.6;  P   < 0.001. ","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Ospedale Nuovo Regina Margherita, Rome, Italy.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Manning', 'Affiliation': 'Borders General Hospital, NHS Borders, Melrose, Berwickshire, UK.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Álvarez González', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Veterans Affairs Medical Center and University of Kansas School of Medicine, Kansas City, Kansas, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Epstein', 'Affiliation': 'Investigative Clinical Research, Annapolis, Maryland, United States.'}, {'ForeName': 'Raf', 'Initials': 'R', 'LastName': 'Bisschops', 'Affiliation': 'KU Leuven, University Hospitals Leuven, Leuven, Belgium.'}]",Endoscopy international open,['10.1055/a-1167-1359']
2946,32676679,Health-related quality of life in survivors of septic shock: 6-month follow-up from the ADRENAL trial.,"PURPOSE


To investigate the impact of hydrocortisone treatment and illness severity on health-related quality of life (HRQoL) at 6 months in septic shock survivors from the ADRENAL trial.
METHODS


Using the EuroQol questionnaire (EQ-5D-5L) at 6 months after randomization we assessed HRQoL in patient subgroups defined by hydrocortisone or placebo treatment, gender, illness severity (APACHE II < or ≥ 25), and severity of shock (baseline peak catecholamine doses < or ≥ 15 mcg/min). Additionally, in subgroups defined by post-randomisation variables; time to shock reversal (days), treatment with renal replacement therapy (RRT), and presence of bacteremia.
RESULTS


At 6 months, there were 2521 survivors. Of these 2151 patients (85.3%-1080 hydrocortisone and 1071 placebo) completed 6-month follow-up. Overall, at 6 months the mean EQ-5D-5L visual analogue scale (VAS) was 70.8, mean utility score 59.4. Between 15% and 30% of patients reported moderate to severe problems in any given HRQoL domain. There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611). In all patients combined, males experienced lower pain levels compared to females [p = 0.0002). Neither higher severity of illness or shock impacted reported HRQoL. In post-randomisation subgroups, longer time to shock reversal was associated with increased problems with mobility (p = < 0.0001]; self-care (p = 0.0.0142), usual activities (p = <0.0001] and pain (p = 0.0384). Amongst those treated with RRT, more patients reported increased problems with mobility (p = 0.0307) and usual activities (p = 0.0048) compared to those not treated. Bacteraemia was not associated with worse HRQoL in any domains of the EQ-5D-5L.
CONCLUSIONS


Approximately one fifth of septic shock survivors report moderate to extreme problems in HRQoL domains at 6 months. Hydrocortisone treatment for septic shock was not associated with improved HRQoL at 6 months. Female gender was associated with worse pain at 6 months.",2020,"There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611).","['septic shock survivors', 'survivors of septic shock', '2151 patients (85.3%-1080']","['RRT', 'hydrocortisone', 'Hydrocortisone', 'hydrocortisone vs. placebo', 'hydrocortisone or placebo', 'hydrocortisone and 1071 placebo', 'EuroQol questionnaire\xa0(EQ-5D-5L']","['health-related quality of life (HRQoL', 'usual activities', 'problems with mobility', 'moderate to severe problems', 'worse pain', 'mean EQ-5D-5L visual analogue scale (VAS', 'pain levels', 'pain', 'EQ-5D-5L domain', 'longer time to shock reversal', 'renal replacement therapy (RRT), and presence of bacteremia', 'mean\xa0VAS', 'mean utility score']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192768', 'cui_str': '1080'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.531361,"There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611).","[{'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Hammond', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia. nhammond@georgeinstitute.org.au.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Finfer', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'King Saud bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Austin and Repatriation Medical Center, Melbourne, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Harward', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Myburgh', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dorrilyn', 'Initials': 'D', 'LastName': 'Rajbhandari', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rhodes', 'Affiliation': ""St. George's Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06169-1']
2947,32676780,"Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis-a prospective, stratified, randomized, controlled trial.","PURPOSE


This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban.
METHODS


The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively.
RESULTS


A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial.
CONCLUSION


The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION


ChiCTR-1800016430 2018-06-01.",2020,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
","['Patients with an Autar score\u2009>\u200910', '599 patients from eight hospitals participated in this clinical trial', 'Patients with an Autar score\u2009≤\u200910', 'patients with high-risk thrombosis', 'patients with stenosis or spondylolisthesis using the combination of']","['tranexamic acid and rivaroxaban', 'TXA', 'posterior lumbar interbody fusion (PLIF', 'tranexamic acid (TXA) and rivaroxaban', '10-mg rivaroxaban', 'rivaroxaban', 'TXA via intravenous injection and 1\xa0g TXA', 'placebo']","['VTE incidence rates', 'blood loss and preventing venous thromboembolism (VTE', 'blood transfusion rate', 'Epidural haematoma', 'probability of thrombosis', 'blood loss and transfusion rates', 'total blood loss, intra-operative blood loss, and drainage volume', 'blood loss and the transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0238154', 'cui_str': 'Epidural hemorrhage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",599.0,0.107914,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Qianfoshan Hospital, 16766 Jingshi Road, Jinan, China.'}, {'ForeName': 'Tingjin', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'Department of Spine Surgery, The First Hospital of Zibo City, 4, East Emeishan Road, Boshan District, Zibo, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Yue', 'Affiliation': ""Department of Spine Surgery, Dezhou People's Hospital, 1166, Dongfanghong West Road, Decheng District, Dezhou, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Hospital of Traditional Chinese Medicine, 16369 Jingshi Road, Jinan, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Spine Surgery, Linyi Central Hospital, 17, Jiankang Road, Yishui County, Linyi, China.'}, {'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Jiao', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Haichun', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Chunyang', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Zhaozhong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Yunzhen', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China. qilucyz@yeah.net.'}]",International orthopaedics,['10.1007/s00264-020-04699-3']
2948,32676833,Correction to: Does Organizing Mentor-Mentee Matches into Small Groups Enhance Treatment Effects in a Site-Based Mentoring Program for Adolescents? Results of a Randomized Controlled Trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],[],[],[],[],[],,0.0383541,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Haddock', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA. shelley.haddock@colostate.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota, St. Paul, MN, 55108, USA.'}, {'ForeName': 'Hyanghee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Toni S', 'Initials': 'TS', 'LastName': 'Zimmerman', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Krafchick', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gereon F', 'Initials': 'GF', 'LastName': 'Fredrickson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Yetz', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Youngblade', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01283-1']
2949,32676868,Colchicine ameliorates the chronic inflammatory state in patients with chronic rheumatic valvular heart disease: a pilot study.,"BACKGROUND


Inflammation is an important contributor to the pathogenesis of rheumatic heart disease (RHD). High serum levels of C-reactive protein (CRP) and interleukin-6 (IL-6) are commonly seen in patients with chronic (RHD) and indicate the presence of a chronic inflammatory state. The aim of this study was to assess the effect of colchicine as anti-inflammatory drug on the serum levels of the inflammatory markers (CRP) and (IL-6) in patients with chronic (RHD).
RESULTS


This is a prospective controlled study that enrolled thirty-five patients with chronic (RHD) visiting Ain Shams University Hospital's outpatient clinic for receiving regular long acting penicillin as rheumatic fever prophylaxis. Ten matched healthy individuals were taken as control group. Blood samples for serum levels of CRP and IL-6 were collected before and 1 month after receiving colchicine 0.5 mg BID. Mean (CRP) level was 6.09 ± 4.39 IU/ml versus 0 IU/ml in the control group respectively (P = 0.0001). Mean (IL-6) level was 113.57 ± 37.41 ng/l versus 10.50 ± 5.99 ng/l, in the control group (p = 0.0001). Mean (CRP) was 6.09 ± 4.39 IU/ml before and became 3.34 ± 3.07I U/ml 1 month after colchicine therapy. Mean (IL-6) level was 113.57 ± 37.4 ng/l before and became 45.57 ± 20.39 ng/l 1 month after colchicine therapy (P = 0.001).
CONCLUSION


In this pilot study, using colchicine as anti-inflammatory drug in patients with chronic (RHD) significantly reduced the serum inflammatory markers (CRP) and (IL-6), thus helping in ameliorating their chronic inflammatory state.",2020,"Mean (IL-6) level was 113.57 ± 37.41 ng/l versus 10.50 ± 5.99 ng/l, in the control group (p = 0.0001).","['Ten matched healthy individuals', 'patients with chronic rheumatic valvular heart disease', ""enrolled thirty-five patients with chronic (RHD) visiting Ain Shams University Hospital's outpatient clinic for receiving regular long acting penicillin as rheumatic fever prophylaxis"", 'patients with chronic (RHD']","['Colchicine', 'colchicine']","['serum inflammatory markers (CRP) and (IL-6', 'Mean (IL-6) level', 'Mean (CRP) level', 'High serum levels of C-reactive protein (CRP) and interleukin-6 (IL-6', 'chronic inflammatory state', 'serum levels of the inflammatory markers (CRP) and (IL-6', 'Mean (CRP', 'Blood samples for serum levels of CRP and IL-6']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0264757', 'cui_str': 'Rheumatic disease of heart valve'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0035436', 'cui_str': 'Rheumatic fever'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",35.0,0.042829,"Mean (IL-6) level was 113.57 ± 37.41 ng/l versus 10.50 ± 5.99 ng/l, in the control group (p = 0.0001).","[{'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Rifaie', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Badr', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Abdel', 'Initials': 'AA', 'LastName': 'Salam', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Galal', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Ain Shams University, Cairo, Egypt. haitham-w@hotmail.com.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00080-2']
2950,32676873,"Efficacy and Safety of a Nasopharyngeal Catheter for Selective Brain Cooling in Patients with Traumatic Brain Injury: A Prospective, Non-randomized Pilot Study.","BACKGROUND


The efficacy objective was to determine whether a novel nasopharyngeal catheter could be used to cool the human brain after traumatic brain injury, and the safety objective was to assess the local and systemic effects of this therapeutic strategy.
METHODS


This was a prospective, non-randomized, interventional clinical trial that involved five patients with severe traumatic brain injury. The intervention consisted of inducing and maintaining selective brain cooling for 24 h by positioning a catheter in the nasopharynx and circulating cold water inside the catheter in a closed-loop arrangement. Core temperature was maintained at ≥ 35 °C using counter-warming.
RESULTS


In all study participants, a brain temperature reduction of ≥ 2 °C was achieved. The mean brain temperature reduction from baseline was 2.5 ± 0.9 °C (P = .04, 95% confidence interval). The mean systemic temperature was 37.3 ± 1.1 °C at baseline and 36.0 ± 0.8 °C during the intervention. The mean difference between the brain temperature and the systemic temperature during intervention was - 1.2 ± 0.8 °C (P = .04). The intervention was well tolerated with no significant changes observed in the hemodynamic parameters. No relevant variations in intracranial pressure and transcranial Doppler were observed. The laboratory results underwent no major changes, aside from the K +  levels and blood counts. The K +  levels significantly varied (P = .04); however, the variation was within the normal range. Only one patient experienced an event of mild localized and superficial nasal discoloration, which was re-evaluated on the seventh day and indicated complete recovery.
CONCLUSION


The results suggest that our noninvasive method for selective brain cooling, using a novel nasopharyngeal catheter, was effective and safe for use in humans.",2020,No relevant variations in intracranial pressure and transcranial Doppler were observed.,"['Patients with Traumatic Brain Injury', 'five patients with severe traumatic brain injury', '35']","['Nasopharyngeal Catheter for Selective Brain Cooling', 'inducing and maintaining selective brain cooling for 24\xa0h by positioning a catheter in the nasopharynx and circulating cold water inside the catheter in a closed-loop arrangement']","['Efficacy and Safety', 'mean brain temperature reduction', 'brain temperature reduction of ≥\u20092', 'intracranial pressure and transcranial Doppler', 'K +  levels and blood counts', 'event of mild localized and superficial nasal discoloration', 'brain temperature and the systemic temperature', 'mean systemic temperature', 'hemodynamic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0179774', 'cui_str': 'Nasopharyngeal catheter'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",5.0,0.0907895,No relevant variations in intracranial pressure and transcranial Doppler were observed.,"[{'ForeName': 'Raphael Einsfeld Simões', 'Initials': 'RES', 'LastName': 'Ferreira', 'Affiliation': 'Departamento de Neurologia e Neurocirurgia, Universidade Federal de São Paulo, Av. Moema 170, Cj. 83. Moema, São Paulo, SP, 04077-020, Brazil. rferreira@unifesp.br.'}, {'ForeName': 'Bernardo Lembo Conde', 'Initials': 'BLC', 'LastName': 'de Paiva', 'Affiliation': 'Serviço de Terapia Intensiva, Hospital Santa Paula, São Paulo, Brazil.'}, {'ForeName': 'Flávio Geraldo Rezende', 'Initials': 'FGR', 'LastName': 'de Freitas', 'Affiliation': 'Departamento de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Departamento de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gisele Sampaio', 'Initials': 'GS', 'LastName': 'Silva', 'Affiliation': 'Departamento de Neurologia e Neurocirurgia, Universidade Federal de São Paulo, Av. Moema 170, Cj. 83. Moema, São Paulo, SP, 04077-020, Brazil.'}, {'ForeName': 'Rafael Mônaco', 'Initials': 'RM', 'LastName': 'Raposo', 'Affiliation': 'Serviço de Otorrinolaringologia UNIFESP e Serviço de Otorrinolaringologia, Hospital Santa Paula, São Paulo, Brazil.'}, {'ForeName': 'Conrado Feisthauer', 'Initials': 'CF', 'LastName': 'Silveira', 'Affiliation': 'Departamento de Neurologia e Neurocirurgia, Universidade Federal de São Paulo, Av. Moema 170, Cj. 83. Moema, São Paulo, SP, 04077-020, Brazil.'}, {'ForeName': 'Ricardo Silva', 'Initials': 'RS', 'LastName': 'Centeno', 'Affiliation': 'Departamento de Neurologia e Neurocirurgia, Universidade Federal de São Paulo, Av. Moema 170, Cj. 83. Moema, São Paulo, SP, 04077-020, Brazil.'}]",Neurocritical care,['10.1007/s12028-020-01052-9']
2951,32676897,Classifying the diagnosis of study participants in clinical trials: a structured and efficient approach.,"BACKGROUND


A challenge in imaging research is a diagnostic classification of study participants. We hypothesised that a structured approach would be efficient and that classification by medical students, residents, and an expert panel whenever necessary would be as valid as classification of all patients by experts.
METHODS


OPTIMACT is a randomised trial designed to evaluate the effectiveness of replacing chest x-ray for ultra-low-dose chest computed tomography (CT) at the emergency department. We developed a handbook with diagnostic guidelines and randomly selected 240 cases from 2,418 participants enrolled in OPTIMACT. Each case was independently classified by two medical students and, if they disagreed, by the students and a resident in a consensus meeting. Cases without consensus and cases classified as complex were assessed by a panel of medical specialists. To evaluate the validity, 60 randomly selected cases not referred to the panel by the students and the residents were reassessed by the specialists.
RESULTS


Overall, the students and, if necessary, residents were able to assign a diagnosis in 183 of the 240 cases (76% concordance; 95% confidence interval [CI] 71-82%). We observed agreement between students and residents versus medical specialists in 50/60 cases (83% concordance; 95% CI 74-93%).
CONCLUSIONS


A structured approach in which study participants are assigned diagnostic labels by assessors with increasing levels of medical experience was an efficient and valid classification method, limiting the workload for medical specialists. We presented a viable option for classifying study participants in large-scale imaging trials (Netherlands National Trial Register number NTR6163).",2020,"We observed agreement between students and residents versus medical specialists in 50/60 cases (83% concordance; 95% CI 74-93%).
","['2,418 participants enrolled in OPTIMACT', '60 randomly selected cases not referred to the panel by the students and the residents were reassessed by the specialists']",['replacing chest x-ray for ultra-low-dose chest computed tomography (CT'],[],"[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],60.0,0.0447482,"We observed agreement between students and residents versus medical specialists in 50/60 cases (83% concordance; 95% CI 74-93%).
","[{'ForeName': 'Tjitske S R', 'Initials': 'TSR', 'LastName': 'van Engelen', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands. t.s.vanengelen@amsterdamumc.nl.'}, {'ForeName': 'Maadrika M N P', 'Initials': 'MMNP', 'LastName': 'Kanglie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Inge A H', 'Initials': 'IAH', 'LastName': 'van den Berk', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Merel L J', 'Initials': 'MLJ', 'LastName': 'Bouwman', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands.'}, {'ForeName': 'Hind J M', 'Initials': 'HJM', 'LastName': 'Suhooli', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands.'}, {'ForeName': 'Sascha L', 'Initials': 'SL', 'LastName': 'Heckert', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Stoker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Patrick M M', 'Initials': 'PMM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Prins', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology experimental,['10.1186/s41747-020-00169-y']
2952,32676959,"Novel Use of Extrapleural Autologous Blood Injection in CT-Guided Percutaneous Lung Biopsy and its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-Center, Prospective, Randomized, and Controlled Clinical Trial.","PURPOSE


To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-only in CT-guided percutaneous lung biopsy.
MATERIALS AND METHODS


One hundred and thirty-nine participants were referred for CT-guided percutaneous lung biopsy, and 81 were randomized into study (EPABI + IABPI, n = 40) and control (IABPI-only, n = 41) groups. In the study group, ~5 ml of autologous blood was injected into the extrapleural space before passing through the parietal and visceral pleura. The primary outcome was the incidence of pneumothorax in two cohorts within 2 weeks after the procedure.
RESULTS


In the per-protocol population, pneumothorax rates were 5.9% and 25.7% in the study and control groups, respectively. The difference between the two groups was -19.8% (95% CI: -36.3%, 3.32%) (p = 0.025). On the other hand, in the population with no intraprocedural deviations, pneumothorax rates were 3.2% and 17.2% in the study and control groups, respectively. The difference between the two groups was -14.0% (95% CI: -29.1%, 1.07%) (p = 0.083). In the control group, 3.45% of the cases required aspiration, while no intervention was required in the study group.
CONCLUSION


The EPABI application along with IABPI is a promising method to decrease the incidence of pneumothorax following CT-guided percutaneous lung biopsy.",2020,"In the control group, 3.45% of the cases required aspiration, while no intervention was required in the study group.
","['One hundred and thirty-nine participants were referred for CT-guided percutaneous lung biopsy, and 81']","['Extrapleural Autologous Blood Injection', 'Intraparenchymal Autologous Blood Patch Injection', 'intraparenchymal autologous blood patch injection (IABPI) or IABPI', 'extrapleural autologous blood injection (EPABI']","['incidence of pneumothorax', 'pneumothorax rates', 'rate of iatrogenic pneumothorax']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}]","[{'cui': 'C0442091', 'cui_str': 'Extrapleural'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0375336', 'cui_str': 'Iatrogenic pneumothorax'}]",139.0,0.0386426,"In the control group, 3.45% of the cases required aspiration, while no intervention was required in the study group.
","[{'ForeName': 'Yaşar', 'Initials': 'Y', 'LastName': 'Türk', 'Affiliation': 'Radiology Department, Medical Faculty, Tekirdağ Namık Kemal University, Namik Kemal Mh., Kampus Cd., 59100, Suleymanpasa, Tekirdağ, Turkey. yturk@nku.edu.tr.'}, {'ForeName': 'Atakan', 'Initials': 'A', 'LastName': 'Küskün', 'Affiliation': 'Radiology Department, Kırklareli State Hospital, Yayla Mh, 39000, Kırklareli, Turkey.'}, {'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Devecioğlu', 'Affiliation': 'Biomedical Engineering Department, Çorlu Engineering Faculty, Tekirdağ Namık Kemal University, Silahtaraga Mh., Çorlu, Tekirdağ, Turkey.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02585-4']
2953,32676976,Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.,"OBJECTIVES


To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
METHODS


A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
RESULTS


An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
CONCLUSIONS


Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).",2020,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","['48 participants (24 cases each arm', 'COVID-19 patients']","['control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir', 'Keguan-1-based integrative therapy']","['adverse events', 'development of ARDS', 'adverse events, time to fever resolution, ARDS development, and lung injury', 'time to fever resolution']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}]",48.0,0.271286,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","[{'ForeName': 'Jia-Bo', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhong-Xia', 'Initials': 'ZX', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Hui', 'Initials': 'JH', 'LastName': 'Dong', 'Affiliation': 'Department of Radiology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Feng', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Niu', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Tian-Jun', 'Initials': 'TJ', 'LastName': 'Jiang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Feng', 'Initials': 'JF', 'LastName': 'Bi', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhao-Fang', 'Initials': 'ZF', 'LastName': 'Bai', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Guo', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Si-Miao', 'Initials': 'SM', 'LastName': 'Yu', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Qiang', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zi-Teng', 'Initials': 'ZT', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Zhan', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Yan', 'Initials': 'PY', 'LastName': 'Li', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jin-Biao', 'Initials': 'JB', 'LastName': 'Ding', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Zhao', 'Affiliation': 'College of Life Science, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Xue-Ai', 'Initials': 'XA', 'LastName': 'Song', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jian-Yuan', 'Initials': 'JY', 'LastName': 'Tang', 'Affiliation': 'Sichuan Evidence-Based Medicine Center of Traditional Chinese Medicine Affliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Dong-Chu', 'Initials': 'DC', 'LastName': 'He', 'Affiliation': 'Department of Integrated Treatment, General Hospital of Central Theater Command, Wuhan, 430070, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Clinical Research Center for Infectious Diseases, Beijing, 100039, China.'}, {'ForeName': 'En-Qiang', 'Initials': 'EQ', 'LastName': 'Qin', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. qeq2004@sina.com.'}, {'ForeName': 'Rui-Lin', 'Initials': 'RL', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. wrl7905@163.com.'}, {'ForeName': 'Xiao-He', 'Initials': 'XH', 'LastName': 'Xiao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. pharmacy302xxh@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3426-7']
2954,32674009,Extracorporeal shockwave therapy in the management of plantar fasciitis: A randomized controlled trial.,"BACKGROUND


This study aimed at estimating the extent to which a combination therapy of extracorporeal shockwave therapy (ESWT) with usual care (exercise and orthotic support) improve functional ability in the patient with plantar fasciitis when compared to usual care alone.
METHODS


Participants with plantar fasciitis were randomly allocated into two groups: ESWT (n=23), and control (n=21). All participants received home exercise program with orthotic support. In addition, ESWT group received 2000 shock waves with 0.02 mJ/mm 2  for three sessions. Functional outcomes were measured by function subscale of American orthopedic foot and ankle society (AOFAS-F) score and 12 minutes walking test including walking speed, cadence. The scores were recorded at baseline, third week and third month after the treatment. Analysis was performed using repeated measures ANOVA, and an intention to treat approach using multiple imputations.
RESULTS


Results showed that there was a significant improvement in AOFAS-F total score and walking speed over three months in both groups (p<0.001, p=0.04 respectively); improvements in AOFAS-F were particularly in activity limitation (p=0.001), walking distance (p=0.02) and walking surface (p=0.02). Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05). However, groups performed differently in cadence where there was an increase in cadence in ESWT group whereas a decline in control at the third month (p=0.07).
CONCLUSION


The results revealed that ESWT did not have an additive benefit over usual care to improve foot function and walking performance in patient with plantar fasciitis over three months post-treatment.",2020,Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05).,"['Participants with plantar fasciitis', 'plantar fasciitis', 'patient with plantar fasciitis']","['ESWT', 'extracorporeal shockwave therapy (ESWT) with usual care (exercise and orthotic support', 'Extracorporeal shockwave therapy', 'home exercise program with orthotic support']","['foot function and walking performance', 'walking surface', 'AOFAS-F total score and walking speed', 'AOFAS-F', 'function subscale of American orthopedic foot and ankle society (AOFAS-F) score and 12 minutes walking test including walking speed, cadence', 'cadence', 'walking distance', 'activity limitation', 'functional ability']","[{'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0430516', 'cui_str': '12-minute walk test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0431827,Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05).,"[{'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cinar', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, 8852 Saint Hubert, Montreal, QC, H2M 1Y5, Canada. Electronic address: edaccinar@gmail.com.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, 8852 Saint Hubert, Montreal, QC, H2M 1Y5, Canada. Electronic address: shikha.saxena@mail.mcgill.ca.'}, {'ForeName': 'Halil Ekrem', 'Initials': 'HE', 'LastName': 'Akkurt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Konya Training and Research Hospital, Konya Eğitim ve Araştırma Hastanesi Fiziksel Tıp ve Rehabilitasyon Kliniği, Meram, Konya, 42090, Turkey. Electronic address: ekremakkurt@yahoo.com.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Uygur', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Science Cyprus International University, via Mersin 10, 99258 Lefkoşa, Turkey. Electronic address: fztuygur@yahoo.com.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101679']
2955,32674036,Effects of a nurse-led medication self-management programme in women with oral treatments for metastatic breast cancer: A mixed-method randomised controlled trial.,"PURPOSE


Adherence to medication is the most important challenge facing patients receiving oral anticancer treatment. This study aimed to evaluate the effects of a patient-centred medication self-management support programme in patients with metastatic breast cancer undergoing oral anticancer treatment.
METHODS


This trial was a two-phased mixed-method randomised controlled study. Eligible participants were 155 patients with metastatic breast cancer newly prescribed an oral chemotherapy or targeted therapy agent. The intervention group received the patient-centred medication self-management support programme conducted by trained nurses. Primary outcome was adherence to medication at three months after the commencement of treatment, calculated by medication possession ratio (MPR). Secondary outcomes included self-efficacy, functional assessment, psychological distress, symptom severity and symptom interference, and patient satisfaction. After the completion of the intervention study, focus group interviews were conducted among intervention nurses.
RESULTS


Both intervention and control groups maintained more than 90% of MPR and no significant difference was observed in the primary outcome. Regarding secondary outcomes, only general self-efficacy was significantly different in the two groups. In the qualitative study, the intervention nurses perceived improvement in the patients' self-efficacy, ability to anticipate the impact of treatment and adjust to life, and avoidance of loneliness.
CONCLUSIONS


A significant effect of the programme was not found in the program because the adherence rate was high in both groups. Improvement in the patients' self-efficacy was observed both quantitatively and qualitatively.
TRIAL REGISTRATION


UMIN Clinical Trials Registry (UMIN-CTR), Japan, UMIN000016597. (27 February 2015).",2020,Both intervention and control groups maintained more than 90% of MPR and no significant difference was observed in the primary outcome.,"['patients receiving oral anticancer treatment', 'Eligible participants were 155 patients with metastatic breast cancer newly prescribed an oral chemotherapy or targeted therapy agent', 'patients with metastatic breast cancer undergoing oral anticancer treatment', 'women with oral treatments for metastatic breast cancer']","['patient-centred medication self-management support programme', 'patient-centred medication self-management support programme conducted by trained nurses', 'nurse-led medication self-management programme']","['self-efficacy, functional assessment, psychological distress, symptom severity and symptom interference, and patient satisfaction', 'adherence to medication', 'adherence rate', 'medication possession ratio (MPR', 'general self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036600', 'cui_str': 'Self-medication'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",155.0,0.0763852,Both intervention and control groups maintained more than 90% of MPR and no significant difference was observed in the primary outcome.,"[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Komatsu', 'Affiliation': 'Japanese Red Cross Kyushu International College of Nursing, 1-1 Asty Munakata-City, Fukuoka-Prefecture, 811-4157, Japan. Electronic address: h-komatsu@jrckicn.ac.jp.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yagasaki', 'Affiliation': 'Faculty of Nursing and Medical Care, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. Electronic address: yagasaki@sfc.keio.ac.jp.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan. Electronic address: yamaguchi@med.tohoku.ac.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Division of Nursing, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. Electronic address: aymori@ncc.go.jp.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kawano', 'Affiliation': 'Nursing Department, Kanagawa Cancer Center, 2-3-1 Nakao, Yokohamashi, Kanagawa, 241-8515, Japan. Electronic address: gairai@kcch.jp.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Minamoto', 'Affiliation': 'Nursing Division, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba-ken, 277-8577, Japan. Electronic address: nminamot@east.ncc.go.jp.'}, {'ForeName': 'Orie', 'Initials': 'O', 'LastName': 'Honma', 'Affiliation': 'Division of Nursing, Showa University Hospital, 1-5-8, Hatanodai, Shinagawaku, Tokyo, 142-8666, Japan. Electronic address: ori-miya20@cmed.showa-u.ac.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. Electronic address: ketamura@ncc.go.jp.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101780']
2956,32674048,"Cyclosporine or methotrexate, which one is more promising in the treatment of lichen planopilaris?; A comparative clinical trial.","BACKGROUND


Lichen Planopilaris (LPP) is a primary scarring alopecia with unknown etiology and its management is a challenge for dermatologists. We aimed to compare the safety and efficacy of methotrexate and cyclosporine in LPP patients.
METHODS


In a randomized clinical trials, 33 patients were randomly allocated to receive either 15-mg oral methotrexate per week or 3-5-mg/kg/day cyclosporine for six months. During the treatment course, side effects, signs/symptoms and laboratory test were assessed periodically. Lichen planopilaris activity index (LPPAI) was measured at baseline and 2, 4, and 6 months after the intervention. Score of both photography and patient's opinion were also obtained. The collected data were analyzed in SPSS software (Ver.25.0. Armonk, NY: IBM Corp).
RESULTS


Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
CONCLUSIONS


Regarding the results of the present study, both cyclosporine and methotrexate are effective in treating refractory lichen planopilaris and we propose methotrexate as a possible earlier choice over cyclosporine. This study was registered in Iranian Registry of Clinical Trials (IRCT20190717044256N1).",2020,"Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
","['LPP patients', '33 patients']","['Lichen Planopilaris (LPP', 'cyclosporine and methotrexate', '15-mg oral methotrexate per week or 3-5-mg/kg/day cyclosporine', 'Cyclosporine or methotrexate', 'methotrexate and cyclosporine', 'cyclosporine']","['side effects, signs/symptoms and laboratory test', 'safety and efficacy', 'Lichen planopilaris activity index (LPPAI', 'signs and symptoms of LPP']","[{'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",33.0,0.113439,"Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
","[{'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Fatemi Naeini', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: fatemi@med.mui.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohaghegh', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: f.mohaghegh@med.mui.ac.ir.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Jelvan', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: minoo.jelvan@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Asilian', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: asilian@med.mui.ac.ir.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Saber', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: mi.saber@med.mui.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106765']
2957,32674098,The Effectiveness and Safety of General and Spinal Anesthesia on Systemic Inflammatory Response in Patients with Tumor-Type Total Knee Arthroplasty.,"BACKGROUND


The anesthesia procedure in tumor-type total knee arthroplasty (TKA) may contribute to systemic inflammatory response. Therefore, we aim to investigate the effectiveness and safety of general and spinal anesthesia in patients with tumor-type TKA.
PATIENTS AND METHODS


Twenty-five patients with tumors around the knee undergoing primary unilateral TKA were randomly divided into the general anesthesia group (n = 13) and spinal anesthesia group (n = 12). Knee joint HSS scores and Western Ontario and McMaster University osteoarthritis index (WOMAC osteoarthritis) were recorded before surgery and 12 months after surgery. Visual analogue scale, C-reactive protein (CPR), tumor necrosis factor-α (TNF-α), and interleukin-8 (IL-8) concentration were measured preoperatively (T0), on the day of the operation (T1), and on the first day (T2) after the operation. Complications in the two groups were recorded.
RESULTS


The operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate were not significantly different between the general anesthesia and spinal anesthesia groups (all p > 0.05). There were no significant differences in CPR (7.6 ± 3.1, 8.1 ± 4.1, 91.3 ± 24.2 vs. 7.1 ± 2.9, 7.6 ± 3.8, 85.1 ± 19.3 pg/mL, respectively), IL-8 (12.2 ± 6.6, 13.4 ± 7.3, 19.2 ± 10.5 vs. 11.9 ± 5.7, 12.9 ± 8.6, 22.2 ± 12.4 pg/mL, respectively), and TNF-α (2.5 ± 1.7, 2.2 ± 1.9, 2.8 ± 2.1 vs. 2.4 ± 1.3, 2.7 ± 2.1, 2.9 ± 1.6 pg/mL, respectively) between the two groups at T0, T1, and T2 (all p > 0.05). There were no statistical differences in pre- and postoperative HSS knee scores (39.78 ± 11.3, 90.24 ± 15.3 vs. 42.68 ± 12.5, 91.21 ± 16.3) and WOMAC indexes (49.89 ± 7.9, 25.12 ± 6.2 vs. 51.3 ± 8.3, 23.15 ± 5.3) between the two groups (p > 0.05).
CONCLUSION


General anesthesia and spinal anesthesia in patients with tumor-type TKA had the same effectiveness and safety.",2020,"The operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate were not significantly different between the general anesthesia and spinal anesthesia groups (all p > 0.05).","['Twenty-five patients with tumors around the knee undergoing primary unilateral TKA', 'tumor-type total knee arthroplasty (TKA', 'Patients with Tumor-Type Total Knee Arthroplasty', 'patients with tumor-type TKA']","['spinal anesthesia group', 'General anesthesia and spinal anesthesia', 'general and spinal anesthesia', 'General and Spinal Anesthesia', 'general anesthesia group']","['operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate', 'WOMAC indexes', 'effectiveness and safety', 'Knee joint HSS scores and Western Ontario and McMaster University osteoarthritis index (WOMAC osteoarthritis', 'pre- and postoperative HSS knee scores', 'Complications', 'Visual analogue scale, C-reactive protein (CPR), tumor necrosis factor-α (TNF-α), and interleukin-8 (IL-8) concentration']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",25.0,0.0436429,"The operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate were not significantly different between the general anesthesia and spinal anesthesia groups (all p > 0.05).","[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Ling Hui', 'Initials': 'LH', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China, plinghui@hotmail.com.'}]",Oncology research and treatment,['10.1159/000507892']
2958,32674103,[Lost in Transition: Is Early Respiratory Support in Newborn Infants the Best Option?],"BACKGROUND


Late preterm and term newborns with respiratory distress are increasingly treated with non-invasive ventilation (NIV) including nasal high-flow or continuous positive airway pressure. For infants with mild distress, NIV may be unnecessary.
OBJECTIVES


We speculated that treatment with supplemental oxygen (SO) prior to NIV could help clinicians select infants for NIV treatment, and examined this hypothesis using data from a recently completed trial.
METHOD


Post hoc analysis of data from a subset of infants enrolled in the HUNTER trial. Infants born at ≥36 weeks' gestation were categorized by whether they were receiving SO prior to randomization. The 2 groups were compared for illness severity (indicated by treatment failure at 72 h, mechanical ventilation, need for up-transfer, SO requirement post-randomization, and length of time receiving respiratory support), use of selected medical interventions (antibiotics, intravenous fluids), and breastfeeding at discharge.
RESULTS


Analysis included 380 infants. Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%). Most infants in both groups received intravenous fluids (93 and 98%) and antibiotics (81 and 93%); the rate of full breastfeeding was low in both groups (51 and 45%).
CONCLUSIONS


Late preterm and term newborn infants without SO requirement at the time of commencing NIV for respiratory distress are at lower risk of requiring treatment escalation. Close observation of these infants (watch and wait strategy) may avoid unnecessary treatment.",2020,"Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%).","[""Infants born at ≥36 weeks' gestation"", 'Late preterm and term newborns with respiratory distress', 'Post hoc analysis of data from a subset of infants enrolled in the HUNTER trial', '380 infants', 'Newborn Infants']",['supplemental oxygen (SO'],"['severe illness; lower rates of treatment failure', 'rate of full breastfeeding', 'mechanical ventilation']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319693', 'cui_str': '380'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",380.0,0.196799,"Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Buckmaster', 'Affiliation': 'Women, Children and Families, Central Coast Local Health District, Gosford, New South Wales, Australia, agbuck@ozemail.com.au.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Arnolda', 'Affiliation': 'Australian Institute for Healthcare Innovation, Macquarie University, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Clayton, Victoria, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}]",Neonatology,['10.1159/000508554']
2959,32674126,Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19: A Randomized-Controlled Trial.,"BACKGROUND


No therapeutics have yet been proven effective for the treatment of mild-illness caused by SARS-CoV-2. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be more efficacious than no-treatment for outpatients with mild Covid-19.
METHODS


We conducted a multicenter, open label, randomized controlled trial in Catalonia (Spain) between March 17, and May 26, 2020. Eligible Covid-19 cases were non-hospitalized adult patients with recently confirmed SARS-CoV-2 infection and less than five days of symptoms. Patients were assigned to receive HCQ (800 mg on day 1, followed by 400 mg once daily for 6 days) or no antiviral treatment (not-placebo controlled). Study outcomes were the reduction of viral RNA load in nasopharyngeal swabs up to 7 days after treatment start, patient disease progression using the WHO scale up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days.
RESULTS


A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD 12.6), mean viral load at baseline was 7.90 (SD 1.82) Log10 copies/mL, and median time from symptom onset to randomization was 3 days. No significant differences were found in the mean reduction of viral load at day 3 (-1.41 vs. -1.41 Log10 copies/mL in the control and intervention arm, respectively; difference 0.01 [95% CI -0.28;0.29]) or at day 7 (-3.37 vs. -3.44; d -0.07 [-0.44;0.29]). This treatment regimen did not reduce risk of hospitalization (7.1%, control vs. 5.9%, intervention; RR 0.75 [0.32;1.77]) nor shortened the time to complete resolution of symptoms (12 days, control vs. 10 days, intervention; p = 0.38). No relevant treatment-related AEs were reported.
CONCLUSIONS


In patients with mild Covid-19, no benefit was observed with HCQ beyond the usual care.",2020,"BACKGROUND


No therapeutics have yet been proven effective for the treatment of mild-illness caused by SARS-CoV-2.","['outpatients with mild Covid-19', 'Catalonia (Spain) between March 17, and May 26, 2020', 'mean age was 41.6 years (SD 12.6), mean viral load at baseline was 7.90 (SD 1.82', '293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm', 'Eligible Covid-19 cases were non-hospitalized adult patients with recently confirmed SARS-CoV-2 infection and less than five days of symptoms', 'Adults with Mild Covid-19']","['no antiviral treatment (not-placebo', 'Hydroxychloroquine', 'HCQ', 'hydroxychloroquine (HCQ']","['time to complete resolution of symptoms', 'Adverse events', 'mean reduction of viral load', 'reduction of viral RNA load', 'risk of hospitalization']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",293.0,0.341086,"BACKGROUND


No therapeutics have yet been proven effective for the treatment of mild-illness caused by SARS-CoV-2.","[{'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Mitjà', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Corbacho-Monné', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ubals', 'Affiliation': 'Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebe', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Peñafiel', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Tobias', 'Affiliation': 'Institute of Environmental Assessment and Water Research (IDAEA), Spanish Council for Scientific Research (CSIC), Barcelona, Spain.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Ballana', 'Affiliation': 'IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alemany', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Riera-Martí', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Pérez', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Suñer', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Pep', 'Initials': 'P', 'LastName': 'Laporte', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Admella', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mitjà', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Clua', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Bertran', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sarquella', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Gavilán', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Ara', 'Affiliation': 'Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Argimon', 'Affiliation': 'Direcció-gerència, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casabona', 'Affiliation': 'Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': ""Equip d'atenció primària de Sarria, Barcelona, Spain.""}, {'ForeName': 'Paz', 'Initials': 'P', 'LastName': 'Cañadas', 'Affiliation': 'SYNLAB, Barcelona, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Elizalde-Torrent', 'Affiliation': 'IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fabregat', 'Affiliation': 'Direcció General de Recerca i Innovació en Salut, Generalitat de Catalunya, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Magí', 'Initials': 'M', 'LastName': 'Farré', 'Affiliation': 'Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forcada', 'Affiliation': 'Gerència territorial de Catalunya Central, Institut Català de la Salut, St Fruitós del Bages, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Flores-Mateo', 'Affiliation': 'Xarxa Sanitària i Social Santa Tecla, Tarragona, Spain.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Muntada', 'Affiliation': 'Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Nadal', 'Affiliation': 'Gerència territorial de Barcelona, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Narejos', 'Affiliation': 'Entitat de Base Asociativa Centelles- Atenció Primària, Centelles, Spain.'}, {'ForeName': 'Aroa N', 'Initials': 'AN', 'LastName': 'Gil-Ortega', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Prat', 'Affiliation': 'Gerència territorial de Àmbit Metropolità nord, Institut Català de la Salut, Sabadell, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Quiñones', 'Affiliation': 'Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Reyes-Ureña', 'Affiliation': 'Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Ramírez-Viaplana', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ruiz', 'Affiliation': 'IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Riveira-Muñoz', 'Affiliation': 'IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Sierra', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Velasco', 'Affiliation': 'Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Vivanco-Hidalgo', 'Affiliation': 'Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Sentís', 'Affiliation': 'Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'G-Beiras', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Bonaventura', 'Initials': 'B', 'LastName': 'Clotet', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Martí', 'Initials': 'M', 'LastName': 'Vall-Mayans', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1009']
2960,32674155,"Corrigendum to: ""Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study"" by Russo et al. Neurosurgery, 2020, nyaa003, https://doi.org/10.1093/neuros/nyaa003.",,2020,,[],['Closed-Loop Spinal Cord Stimulation'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]",[],,0.0133076,,[],Neurosurgery,['10.1093/neuros/nyaa332']
2961,32674202,Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.,"OBJECTIVE


This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities.
STUDY DESIGN


A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle.
RESULTS


Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group ( n  = 42) or individual ( n  = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care;  p  < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9];  p  = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms.
CONCLUSION


Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes.
KEY POINTS


· Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..",2020,"The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence.","['· Women with gestational diabetes in group care', '159 eligible women, 84 (53%) consented to participate in the study and were randomized to group ( n \u2009=\u200942) or individual ( n \u2009=\u200942) prenatal care', 'women with diabetes in pregnancy', '· Women with gestational diabetes', 'women with pregnancies complicated by diabetes', 'Women with gestational diabetes', 'Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized', 'Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness']","['Diabetes Group Prenatal Care', 'Diabetes Group Prenatal Care or individual prenatal care']","['gestational weight gain', 'postpartum glucose tolerance testing', 'completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence', 'antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1444698', 'cui_str': 'Specified time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",159.0,0.0920803,"The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence.","[{'ForeName': 'Ebony B', 'Initials': 'EB', 'LastName': 'Carter', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Barbier', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Pamela K', 'Initials': 'PK', 'LastName': 'Hill', 'Affiliation': 'Department of Obstetrics and Gynecology, Denver Health and Hospital, Denver, Colorado.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell Medical School, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine,, St. Louis, Missouri.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell Medical School, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama.'}]",American journal of perinatology,['10.1055/s-0040-1714209']
2962,32674204,The Role of Lung Ultrasound as an Early Diagnostic Tool for Need of Surfactant Therapy in Preterm Infants with Respiratory Distress Syndrome.,"OBJECTIVE


This study aimed to determine the accuracy of neonatal lung ultrasound (LUS) in predicting the need for surfactant therapy compared with chest X-ray (CXR) in preterm infants.
STUDY DESIGN


A prospective double-blind study was conducted in infants with a gestational age <34 weeks with respiratory distress syndrome (RDS) by evaluation with LUS and CXR on admission.
RESULTS


Among 45 preterm infants, the median (interquartile range [IQR]) LUS score was 4 (2-8) in the mild RDS group, whereas it was 10 (IQR: 9-12) in the severe RDS group ( p  < 0.01). The LUS score showed a significant correlation with the need for total surfactant doses ( ρ  = 0.855; 95% confidence interval [CI]: 0.801-0.902;  p  < 0.001). A cut-off LUS score of four predicted the need for surfactant with 96% sensitivity and 100% specificity (area under the curve [AUC]: 1.00; 95% CI: 0.97-1.00;  p  < 0.01). LUS scores predicted continuous positive airway pressure (CPAP) failure accurately (AUC: 0.804; 95% CI: 0.673-0.935;  p  = 0.001). A significant correlation was observed between LUS scores and positive end-expiratory pressure levels ( ρ  = 0.782;  p  < 0.001). During the study period, the CXR number per infant with RDS decreased significantly when compared with preceding months ( p  < 0.001). The LUS score in the first day of life did not predict the development of bronchopulmonary dysplasia (AUC: 0.274; 95% CI: 0.053-0.495;  p  = 0.065).
CONCLUSION


The LUS score in preterm infants accurately predicts the severity of RDS, the need for surfactant and CPAP failure. The routine use of LUS can decrease the frequency of CXRs in the neonatal intensive care units.
KEY POINTS


· LUS is a nonhazardous bedside technique.. · LUS predicts the need for surfactant in preterm infants.. · LUS predicts the severity of RDS better than CXR..",2020,LUS scores predicted continuous positive airway pressure (CPAP) failure accurately (AUC: 0.804; 95% CI: 0.673-0.935;  p  = 0.001).,"['infants with a gestational age <34 weeks with respiratory distress syndrome (RDS) by evaluation with LUS and CXR on admission', '45 preterm infants, the median (interquartile range [IQR', 'Preterm Infants with Respiratory Distress Syndrome', 'preterm infants']","['chest X-ray (CXR', 'Lung Ultrasound', 'neonatal lung ultrasound (LUS', 'LUS']","['LUS scores and positive end-expiratory pressure levels', 'LUS scores predicted continuous positive airway pressure (CPAP) failure', 'CXR number per infant with RDS', 'frequency of CXRs', 'LUS score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",45.0,0.130041,LUS scores predicted continuous positive airway pressure (CPAP) failure accurately (AUC: 0.804; 95% CI: 0.673-0.935;  p  = 0.001).,"[{'ForeName': 'Gonca', 'Initials': 'G', 'LastName': 'Vardar', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, University of Health Sciences, Zeynep Kamil Maternity and Children's Disease Health Training and Research Center, Istanbul, Turkey.""}, {'ForeName': 'Nilgun', 'Initials': 'N', 'LastName': 'Karadag', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, University of Health Sciences, Zeynep Kamil Maternity and Children's Disease Health Training and Research Center, Istanbul, Turkey.""}, {'ForeName': 'Guner', 'Initials': 'G', 'LastName': 'Karatekin', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, University of Health Sciences, Zeynep Kamil Maternity and Children's Disease Health Training and Research Center, Istanbul, Turkey.""}]",American journal of perinatology,['10.1055/s-0040-1714207']
2963,32674229,A preoperative whey protein and glucose drink before hip fracture surgery in the aged improves symptomatic and metabolic recovery.,"BACKGROUND AND OBJECTIVES


We investigated the effects of a carbohydrate-whey protein solution on aged patients undergoing hip fracture surgery.
METHODS AND STUDY DESIGN


Forty patients were randomly assigned to the carbohydrate-whey protein (CHP) group or the control group (CTL). In the CHP group, a mixed solution of CHP was orally administered to patients before surgery: 400 mL was administered on the day before surgery, and 200 mL was administered 3 h before surgery. The size of the liquid dark area in the gastric antrum was measured by ultrasound, and the bleeding volume during surgery was assayed. The incidence of nausea, vomiting, thirst, hunger, and days of hospitalization and the levels of blood glucose, C-reactive protein (CRP) and serum albumin were assessed.
RESULTS


There was no obvious liquid dark space in the gastric antrum. CHP administration improved postoperative thirst and hunger and resulted in increased albumin levels and decreased CRP concentrations and blood glucose fluctuations.
CONCLUSIONS


Oral CHP before hip fracture surgery reduces the incidence of postoperative thirst and hunger and improves recovery in the aged.",2020,"CHP administration improved postoperative thirst and hunger and resulted in increased albumin levels and decreased CRP concentrations and blood glucose fluctuations.
","['aged patients undergoing hip fracture surgery', 'Forty patients']","['carbohydrate-whey protein solution', 'CHP', 'preoperative whey protein and glucose drink before hip fracture surgery', 'carbohydrate-whey protein (CHP) group or the control group (CTL']","['obvious liquid dark space', 'CRP concentrations and blood glucose fluctuations', 'postoperative thirst and hunger', 'albumin levels', 'incidence of nausea, vomiting, thirst, hunger, and days of hospitalization and the levels of blood glucose, C-reactive protein (CRP) and serum albumin', 'postoperative thirst and hunger and improves recovery', 'symptomatic and metabolic recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0877314', 'cui_str': 'Blood glucose fluctuation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",40.0,0.0666127,"CHP administration improved postoperative thirst and hunger and resulted in increased albumin levels and decreased CRP concentrations and blood glucose fluctuations.
","[{'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Affiliated Suzhou Hospital of Nanjing Medical University, The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou Science and Technology Town Hospital, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Affiliated Suzhou Hospital of Nanjing Medical University, The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou Science and Technology Town Hospital, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Affiliated Suzhou Hospital of Nanjing Medical University, The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou Science and Technology Town Hospital, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Jiemei', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Affiliated Suzhou Hospital of Nanjing Medical University, The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou Science and Technology Town Hospital, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Institute of Clinical Medicine Research, The Affiliated Suzhou Hospital of Nanjing Medical University, The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Shigang', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Affiliated Suzhou Hospital of Nanjing Medical University, The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou Science and Technology Town Hospital, Suzhou, Jiangsu Province, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Affiliated Suzhou Hospital of Nanjing Medical University, The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou Science and Technology Town Hospital, Suzhou, Jiangsu Province, China. Email: anesthesia_chen@163.com.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.202007_29(2).0004']
2964,32677124,Comparing story reading and video watching as two distinct forms of vicarious contact: An experimental intervention among elementary school children.,"Research has shown that vicarious contact, that is observing an interaction between ingroup and outgroup members, can improve intergroup relations. Although vicarious contact has been operationalized in different ways, mainly via story reading or video watching, an experimental comparison of these different strategies is still missing. We conducted a school intervention with the aim of comparing the two most used forms of vicarious contact, namely story reading and video watching. Elementary schoolchildren without disabilities (N = 292) were assigned to one of three different conditions: reading a story; watching a video; control. In the two vicarious contact conditions, participants read or watched the story of a child with disability becoming friends with children without disabilities; in the control condition, participants only completed the dependent measures. Results revealed that, in general, both vicarious contact conditions were equally effective in improving outgroup attitudes and behavioural intentions. In addition, they operated with the same strength through the same underlying processes (IOS, ingroup norms). We discuss theoretical and practical implications in the context of vicarious contact as a prejudice-reduction intervention.",2020,"Results revealed that, in general, both vicarious contact conditions were equally effective in improving outgroup attitudes and behavioural intentions.","['elementary school children', 'Elementary schoolchildren without disabilities (N\xa0=\xa0292']","['reading a story; watching a video; control', 'vicarious contact, namely story reading and video watching', 'story reading and video watching as two distinct forms of vicarious contact']",['outgroup attitudes and behavioural intentions'],"[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",292.0,0.0168312,"Results revealed that, in general, both vicarious contact conditions were equally effective in improving outgroup attitudes and behavioural intentions.","[{'ForeName': 'Veronica Margherita', 'Initials': 'VM', 'LastName': 'Cocco', 'Affiliation': 'University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Bisagno', 'Affiliation': 'University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Gian Antonio', 'Initials': 'GA', 'LastName': 'Di Bernardo', 'Affiliation': 'University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Cadamuro', 'Affiliation': 'University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Sara Debora', 'Initials': 'SD', 'LastName': 'Riboldi', 'Affiliation': 'University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Crapolicchio', 'Affiliation': 'University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Trifiletti', 'Affiliation': 'University of Verona, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Stathi', 'Affiliation': 'University of Greenwich, UK.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Vezzali', 'Affiliation': 'University of Modena and Reggio Emilia, Italy.'}]",The British journal of social psychology,['10.1111/bjso.12404']
2965,32677139,Effectiveness of life skills education and psychoeducation on emotional and behavioral problems among adolescents in institutional care in Kenya: a longitudinal study.,"BACKGROUND


This study aimed to test the effectiveness of life skills education (LSE) and psychoeducation in the reduction of Youth Self Report (YSR) scores on institutionalized children using structured activities supported by trained facilitators. LSE involved participation of children in life skills activities to support development of key psychosocial competencies and interpersonal skills.
METHODS


The study included 630 children from three institutions. Of these, 171 were in the Intervention Group 1 (life skills education and psychoeducation), 162 were in the Intervention Group 2 (psychoeducation only), and 297 children were in the control group. A researcher-developed socio-demographic questionnaire and the YSR were used. Baseline assessments were conducted before the interventions and again at 3, 6, and 9 months. Differences between the two intervention groups and the control group were investigated using least squares linear regression.
RESULTS


There was a statistically significant reduction in scores in internalizing, externalizing, and total problem scores in both intervention arms (p < .05) compared with the control arm at 3 months. At 6 months, no significant differences were found between the intervention Group 1 and control group for internalizing score (p = .594); however, there were significant differences in both intervention groups for both externalizing and total problem scores (p < .05). At 9 months, significant differences were observed between control and both intervention groups for externalizing scores; total problems for Intervention Group 1.
CONCLUSIONS


A combination of Life Skills Education and psychoeducation is effective in reducing emotional and behavioral problems in institutionalized children.",2018,"There was a statistically significant reduction in scores in internalizing, externalizing, and total problem scores in both intervention arms (p < .05) compared with the control arm at 3 months.","['adolescents in institutional care in Kenya', '297 children were in the control group', '630 children from three institutions', 'institutionalized children']","['LSE', 'life skills education and psychoeducation', 'life skills education (LSE) and psychoeducation', 'Life Skills Education and psychoeducation']","['externalizing and total problem scores', 'Youth Self Report (YSR) scores', 'internalizing score', 'externalizing scores; total problems', 'scores in internalizing, externalizing, and total problem scores', 'emotional and behavioral problems']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008099', 'cui_str': 'Institutionalized Child'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",630.0,0.030482,"There was a statistically significant reduction in scores in internalizing, externalizing, and total problem scores in both intervention arms (p < .05) compared with the control arm at 3 months.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Mutiso', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tele', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Musyimi', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Isaiah', 'Initials': 'I', 'LastName': 'Gitonga', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Abednego', 'Initials': 'A', 'LastName': 'Musau', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ndetei', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}]",Child and adolescent mental health,['10.1111/camh.12232']
2966,32677145,"Cluster-randomised controlled trial of an occupational therapy intervention for children aged 11-13 years, designed to increase participation to prevent symptoms of mental illness.","BACKGROUND


The impact of occupational therapy on mental health outcomes for children is largely unexplored. The aim of this study was to investigate an evidence-based occupational therapy intervention designed to increase participation in daily occupations to prevent symptoms of mental illness for children and run in schools.
METHODS


The study used a pragmatic, cluster-randomised controlled trial design with two arms. Fourteen clusters (schools), equating to 151 child participants, were stratified by school decile-rank category and block randomised. Blinding of participants post-randomisation was not feasible; however, outcomes assessors were blinded. Outcomes were measured at baseline, after the parallel and crossover phases, and at follow-up; and were anxiety symptoms (primary), depression symptoms, self-esteem, participation and wellbeing. Intention-to-treat analysis was applied and mixed linear modelling was used to account for clusters and repeated measures, and to adjust for covariates identified.
RESULTS


This trial found significant positive effects of the intervention on child-rated satisfaction with their occupational performance and teacher-rated child anxiety. No evidence was found to support the effect of the intervention on anxiety and depression symptoms, self-esteem and wellbeing.
CONCLUSIONS


This was the first known cluster-randomised controlled trial to investigate an occupational therapy intervention promoting emotional wellbeing in a non-clinical sample of children. No compelling evidence was found to support the use of the intervention in schools in its current format, however, results were promising that the focus on occupations influenced participation. Recommendations are made to redesign the intervention as an embedded intervention in the classroom, cotaught by teachers and including parental involvement.",2018,"No evidence was found to support the effect of the intervention on anxiety and depression symptoms, self-esteem and wellbeing.
","['children and run in schools', 'children aged 11-13\xa0years', 'a non-clinical sample of children', 'Fourteen clusters (schools), equating to 151 child participants, were stratified by school decile-rank category and block randomised']","['occupational therapy', 'occupational therapy intervention']","['emotional wellbeing', 'mental health outcomes', 'anxiety and depression symptoms, self-esteem and wellbeing', 'child-rated satisfaction with their occupational performance and teacher-rated child anxiety', 'anxiety symptoms (primary), depression symptoms, self-esteem, participation and wellbeing']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0441727', 'cui_str': 'Ranked categories'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",151.0,0.160513,"No evidence was found to support the effect of the intervention on anxiety and depression symptoms, self-esteem and wellbeing.
","[{'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Tokolahi', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kersten', 'Affiliation': 'University of Brighton, Brighton, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pearson', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Hocking', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}]",Child and adolescent mental health,['10.1111/camh.12270']
2967,32677156,DTI Tract-Based Quantitative Susceptibility Mapping: An Initial Feasibility Study to Investigate the Potential Role of Myelination in Brain Connectivity Change in Cerebral Palsy Patients During Autologous Cord Blood Cell Therapy Using a Rotationally-Invariant Quantitative Measure.,"BACKGROUND


Previous studies using diffusion tensor imaging (DTI)-based connectome analysis revealed improved connectivity in cerebral palsy (CP) patients who underwent autologous umbilical cord blood (UCB) stem-cell therapy. However, the potential mechanism for the connectivity increase remains unclear and needs to be further elucidated.
PURPOSE


To develop a technique with improved accuracy for quantitative susceptibility mapping (QSM) with unique sensitivity to myelin, and demonstrate its use in elucidating the underlying mechanism of the observed motor function improvement and brain connectivity increase in CP patients who received autologous UCB stem-cell therapy.
STUDY TYPE


Prospective.
POPULATION


A cohort of eight pediatric CP patients (2.6 ± 0.6 years of age) with intact corticospinal tracts (CST) from a randomized, placebo-controlled trial of autologous UCB stem-cell therapy in CP children was included in this study.
FIELD STRENGTH/SEQUENCE


DTI and 3D spoiled gradient recalled (SPGR) QSM at 3.0T.
ASSESSMENT


Pre- and posttreatment magnetic susceptibility (χ) and the rotationally-invariant magnetic susceptibility anisotropy (MSA) along the CST were derived. Behavioral changes were assessed using the 66-item Gross Motor Function Measurement. Changes in χ and MSA were compared between patients with and without substantial behavioral improvements.
STATISTICAL TESTS


Two-sample t-tests were performed to assess the differences in the changes of measurements of interest (Δχ, ΔMSA, and ΔFA) between patients who significantly improved and those who did not.
RESULTS


Patients who demonstrated posttreatment motor improvements exceeding expectations showed significantly more diamagnetic Δχ in the periventricular region along the CST (P = 0.003). Further analysis on the ΔMSA of this region was significantly increased (P = 0.006) for high responders, along with concurrent FA increase.
DATA CONCLUSION


These initial findings suggest that the DTI tract-based QSM method has the potential to characterize white matter changes associated with behavioral improvements in CP children who underwent cord blood stem-cell therapy.
LEVEL OF EVIDENCE


2 TECHNICAL EFFICACY: Stage 2.",2020,"Further analysis on the ΔMSA of this region was significantly increased (P = 0.006) for high responders, along with concurrent FA increase.
","['A cohort of eight pediatric CP patients (2.6\u2009±\u20090.6\u2009years of age) with intact corticospinal tracts (CST', 'Cerebral Palsy Patients', 'cerebral palsy (CP) patients who underwent', 'CP patients who received autologous UCB stem-cell therapy', 'CP children who underwent cord blood stem-cell therapy']","['autologous UCB stem-cell therapy', 'diffusion tensor imaging (DTI)-based connectome analysis', 'Autologous Cord Blood Cell Therapy', 'autologous umbilical cord blood (UCB) stem-cell therapy', 'placebo']","['changes of measurements of interest (Δχ, ΔMSA, and ΔFA', 'Behavioral changes']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1636284', 'cui_str': 'Cord blood stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3494406', 'cui_str': 'Connectome'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",8.0,0.0347962,"Further analysis on the ΔMSA of this region was significantly increased (P = 0.006) for high responders, along with concurrent FA increase.
","[{'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Brain Imaging and Analysis Center, Duke University Medical Center, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ellor', 'Affiliation': 'Department of Neurology, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'The Robertson Clinical and Translational Cell Therapy Program, Duke University, Durham, North California, USA.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Electrical Engineering and Computer Sciences, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Kurtzburg', 'Affiliation': 'The Robertson Clinical and Translational Cell Therapy Program, Duke University, Durham, North California, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Song', 'Affiliation': 'Brain Imaging and Analysis Center, Duke University Medical Center, Duke University, Durham, North Carolina, USA.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27286']
2968,32677215,Family functioning moderates the impact of depression treatment on adolescents' suicidal ideations.,"PURPOSE


The purpose of this study was to explore whether adolescent-perceived family functioning moderates the depression treatment effects on suicidal ideations.
METHODS


This is a nonpreregistered exploratory secondary analysis of the TADS RCT, which included four treatment groups: fluoxetine, CBT, their combination, and placebo. A random coefficients regression model with posteriori CONTRAST statements was conducted to examine the effects of depression treatment on adolescents' suicidal ideations over time (N = 439). Baron and Kenny's (1986) and Kraemer et al.'s (2002) approach was followed to explore family functioning as a potential moderator of the treatment effects on suicidal ideations over time.
RESULTS


Adolescents in the four treatment groups did not differ significantly in their suicidal ideations at initial status; however, those in the combination group had faster reduction in suicidality. Family functioning moderated the relationship between depression treatment and adolescents' suicidal ideations. In particular, the results revealed that for adolescents who reported positive family functioning (n = 249), treatment had a significant impact on their suicidal ideations over time. However, for adolescents who reported negative family functioning (n = 190), type of treatment did not have a differential effect on improvement in severity of suicidal ideation over time.
CONCLUSION


Findings provided evidence that the process by which depression treatment impacts adolescents' suicidality is contingent upon their family environment. Family-centered approaches to adolescent depression treatment are recommended.",2019,"RESULTS


Adolescents in the four treatment groups did not differ significantly in their suicidal ideations at initial status; however, those in the combination group had faster reduction in suicidality.","[""adolescents' suicidal ideations"", ""adolescents' suicidal ideations over time (N\xa0=\xa0439""]","['fluoxetine, CBT, their combination, and placebo']","['suicidality', 'suicidal ideations', 'severity of suicidal ideation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0459547,"RESULTS


Adolescents in the four treatment groups did not differ significantly in their suicidal ideations at initial status; however, those in the combination group had faster reduction in suicidality.","[{'ForeName': 'Latefa Ali', 'Initials': 'LA', 'LastName': 'Dardas', 'Affiliation': 'School of Nursing, The University of Jordan, Amman, Jordan.'}]",Child and adolescent mental health,['10.1111/camh.12323']
2969,32677216,A randomized controlled trial of internet-delivered cognitive behaviour therapy for adolescent anxiety disorders in a routine clinical care setting with and without parent sessions.,"BACKGROUND


Computerized treatments have been shown to be effective in young people with anxiety disorders within research settings. The aims of this study were to evaluate a self-completed, therapist-supported online treatment for adolescent anxiety disorders in a routine clinical care setting and examine whether additional sessions for parents improved treatment outcome.
METHOD


Sixty adolescents (13-18 years) referred by primary and secondary care services for treatment of an anxiety disorder and their parent(s) were randomly allocated to begin treatment immediately or after a 16-week waitlist. Half the parents (receiving treatment immediately or after a waitlist) were allocated to receive sessions themselves. Assessments were conducted pre- and posttreatment and at 6-month follow-up.
RESULTS


There was no significant difference posttreatment between the immediate treatment and waitlist groups in remission of primary anxiety disorder (Odds Ratio (OR) = 2.19, 95% CI: 0.72-6.70). Parent sessions did not significantly improve adolescent outcomes immediately or at 6-month follow-up (OR = 0.75, 95% CI: 0.26-2.15; OR = 1.14, 95% CI: 0.42-3.15).
CONCLUSIONS


Within a routine clinical care setting, a therapist-supported online treatment failed to deliver significantly better outcomes for adolescents with anxiety disorders than a waitlist. Further research is needed to develop more effective treatments for this population.",2019,"Parent sessions did not significantly improve adolescent outcomes immediately or at 6-month follow-up (OR = 0.75, 95% CI: 0.26-2.15; OR = 1.14, 95% CI: 0.42-3.15).
","['adolescent anxiety disorders', 'Sixty adolescents (13-18\xa0years) referred by primary and secondary care services for treatment of an anxiety disorder and their parent(s', 'adolescent anxiety disorders in a routine clinical care setting with and without parent sessions', 'young people with anxiety disorders within research settings', 'adolescents with anxiety disorders']","['therapist-supported online treatment', 'internet-delivered cognitive behaviour therapy']","['adolescent outcomes', 'remission of primary anxiety disorder']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",,0.0586422,"Parent sessions did not significantly improve adolescent outcomes immediately or at 6-month follow-up (OR = 0.75, 95% CI: 0.26-2.15; OR = 1.14, 95% CI: 0.42-3.15).
","[{'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Waite', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Marshall', 'Affiliation': 'CAMHS Anxiety & Depression Pathway, Berkshire Healthcare Foundation Trust, School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Creswell', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}]",Child and adolescent mental health,['10.1111/camh.12311']
2970,32677243,Mindfulness-based stress reduction for mental health in youth: a cluster randomized controlled trial.,"BACKGROUND


Mental illness is among the most common causes of morbidity, mortality, and disability in childhood. Mindfulness-based stress reduction (MBSR) has shown significant benefit in mental health; however, evidence of its effectiveness in youth is limited. The objective of this study was to compare the efficacy of MBSR plus usual care versus usual care alone for reducing mental health symptoms in youth.
METHODS


A two-arm, mixed methods, randomized cluster-controlled trial of 12-18 year olds who were residents of CASA House, a voluntary residential treatment program for adolescents, between January 2011 and March 2013 (clinicaltrials.gov, NCT01307943).
INTERVENTIONS


Treatment terms were randomized to usual care, or MBSR plus usual care, which included eight MBSR sessions of 2 hr/week.
OUTCOMES


The primary outcome was impact on emotions and behavior at the end of the program, using the Behavior Assessment System for Children, Second Edition (BASC-2). Secondary outcomes included perceived stress levels, mindfulness, and emotional regulation.
RESULTS


A total of 85 participants were randomized to either the MBSR arm (n = 45) or control arm (n = 40). Significant differences in favor of MBSR were found on Teacher ratings of the Internalizing Problems (p = .038) and Adaptive Skills subscales (p = .022) on the BASC-2. No significant differences were found on other outcomes. A post hoc analysis found that the MBSR arm had a significantly shorter time to discharge (p = .02).
CONCLUSION


The results of this study indicate that MBSR is effective for improved coping with internalizing problems and adaptive emotional skills in our sample. Future studies should focus on larger, longer-term studies in youth.",2019,Significant differences in favor of MBSR were found on Teacher ratings of the Internalizing Problems (p = .038) and Adaptive Skills subscales (p = .022) on the BASC-2.,"['mental health in youth', 'youth', '85 participants', '12-18\xa0year olds who were residents of CASA House, a voluntary residential treatment program for adolescents, between January 2011 and March 2013 (clinicaltrials.gov, NCT01307943']","['MBSR plus usual care versus usual care alone', 'MBSR', 'usual care, or MBSR plus usual care, which included eight MBSR sessions of 2\xa0hr/week', 'Mindfulness-based stress reduction (MBSR', 'Mindfulness-based stress reduction']","['shorter time to discharge', 'Adaptive Skills subscales', 'MBSR', 'Teacher ratings of the Internalizing Problems', 'mental health symptoms', 'stress levels, mindfulness, and emotional regulation', 'emotions and behavior at the end of the program, using the Behavior Assessment System for Children, Second Edition (BASC-2']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}]",85.0,0.176824,Significant differences in favor of MBSR were found on Teacher ratings of the Internalizing Problems (p = .038) and Adaptive Skills subscales (p = .022) on the BASC-2.,"[{'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Vohra', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Punja', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sibinga', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Baydala', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Pediatrics, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Wikman', 'Affiliation': 'Department of Educational Psychology, Misericordia Hospital Child Health Clinic, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Faculty of Science, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Dolcos', 'Affiliation': 'Psychology Department, Neuroscience Program, Beckman Institute for Advanced Science & Technology, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL, USA.'}, {'ForeName': 'K Jessica', 'Initials': 'KJ', 'LastName': 'Van Vliet', 'Affiliation': 'Department of Educational Psychology, University of Alberta, Edmonton, AB, Canada.'}]",Child and adolescent mental health,['10.1111/camh.12302']
2971,32677273,A safe and reliable technique for fascial closure without special devices after laparoscopic surgery.,"INTRODUCTION


To prevent port-site hernia, we established a simple and low-cost closure method that uses a venous catheter needle and suture, without any other special devices.
MATERIALS AND SURGICAL TECHNIQUE


We used the inner needle of a 16-G venous catheter and a 2-0 absorbable bladed suture. To evaluate the efficacy of this technique, the procedure time was noted and compared among three operators (an experienced surgeon and two inexperienced surgeons).
DISCUSSION


The median suturing time was 60.5 seconds (range, 26-130 seconds) per incision. Even an unexperienced surgeon can close the fascia safely and quickly after some experience with the procedure.",2020,"The median suturing time was 60.5 seconds (range, 26-130 seconds) per incision.",[],['16-G venous catheter and a 2-0 absorbable bladed suture'],['median suturing time'],[],"[{'cui': 'C0456636', 'cui_str': '16G'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0227485,"The median suturing time was 60.5 seconds (range, 26-130 seconds) per incision.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Takemoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Karakuchi', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Shimomura', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Ohmori', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Toyota', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Sadamoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}, {'ForeName': 'Tadateru', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima, Japan.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12809']
2972,32677375,"Effect of peramivir on respiratory symptom improvement in patients with influenza virus infection and pre-existing chronic respiratory disease: Findings of a randomized, open-label study.","BACKGROUND


The efficacy of neuraminidase inhibitors on improvement of respiratory symptoms triggered by influenza in patients with pre-existing chronic respiratory diseases is unknown.
METHODS


This 2-week, randomized, open-label study evaluated intravenous peramivir 600 mg on two consecutive days (peramivir-repeat), peramivir 300 mg single dose (peramivir-single), and oral oseltamivir 75 mg twice daily for 5 days in patients with confirmed influenza and chronic respiratory diseases. Patients recorded symptom scores daily. The primary endpoint of cumulative area of time vs symptoms (CATVS) was expressed as an index value of area under the curve vs time of the total score of cough, sore throat, and nasal congestion from baseline to 2 weeks.
RESULTS


Of 214 randomized patients, 209 (56% female, 77% aged <65 years, 94% outpatients, 91% bronchial asthma, 62% influenza A) received ≥1 dose of study drug. Mean (standard deviation) CATVS was similar for peramivir-repeat (782.78 [487.17]) vs peramivir-single (717.35 [347.55]; P = .4371), and for peramivir-repeat vs oseltamivir (856.34 [404.99]; P = 1.00). However, CATVS was significantly shorter for peramivir-single vs oseltamivir, with an estimated treatment difference (TD) of -145.07 (95% confidence interval: -284.57, -5.56; P = .0416). In subgroup analyses, CATVS was significantly shorter for peramivir-single vs oseltamivir among patients with influenza A (TD: -206.31 [-383.86, -28.76]; P = .0231), bronchial asthma (TD: -156.57 [-300.22, -12.92]; P = .0328), baseline respiratory severity score <5 (TD: -265.32 [-470.42, -60.21]; P = .0120), and age <65 (TD: -184.30 [-345.08, -23.52]; P = .0249).
CONCLUSIONS


In patients with chronic respiratory diseases, peramivir-single was not significantly different from peramivir-repeat and was more effective than oseltamivir at alleviating respiratory symptoms.",2020,"(TD: -265.32 [-470.42, -60.21]; P = .0120), and age <65 (TD: -184.30 [-345.08, -23.52]; P = .0249).
","['patients with influenza A', 'patients with pre-existing chronic respiratory diseases', '214 randomized patients, 209 (56% female, 77% aged <65\xa0years, 94% outpatients, 91% bronchial asthma, 62% influenza A', 'patients with confirmed influenza and chronic respiratory diseases', 'patients with influenza virus infection and pre-existing chronic respiratory disease']","['neuraminidase inhibitors', 'peramivir', 'intravenous peramivir 600\xa0mg on two consecutive days (peramivir-repeat), peramivir 300\xa0mg single dose (peramivir-single), and oral oseltamivir']","['baseline respiratory severity score', 'cumulative area of time vs symptoms (CATVS', 'Mean (standard deviation', 'respiratory symptom improvement', 'index value of area under the curve vs time of the total score of cough, sore throat, and nasal congestion', 'symptom scores daily']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C1443650', 'cui_str': 'Neuraminidase inhibitor'}, {'cui': 'C1675326', 'cui_str': 'peramivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",214.0,0.0501296,"(TD: -265.32 [-470.42, -60.21]; P = .0120), and age <65 (TD: -184.30 [-345.08, -23.52]; P = .0249).
","[{'ForeName': 'Motokazu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Chest Disease Clinical and Research Institute, Kishiwada City Hospital, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saisho', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Sapporo Cough Asthma and Allergy Center, Sapporo, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Bando', 'Affiliation': 'Bando Internal Medicine Clinic, Hakusan, Ishikawa, Japan.'}]",Influenza and other respiratory viruses,['10.1111/irv.12788']
2973,32677390,[Efficacy of Oral Corticosteroids in Preventing Esophageal Stenosis after Large Area Endoscopic Submucosal Tunnel Dissection].,"OBJECTIVE


To evaluate the efficacy of oral corticosteroids in preventing esophageal stenosis after large area esophageal endoscopic submucosal tunnel dissection (ESTD).
METHODS


The patients undertook esophageal ESTD were included from January 2014 to January 2018. The inclusion criteria was single lesion of esophageal early esophagus cancer with the extent more than 3/4 of circumferential degree. According to the inclusion time, the patients were divided into the trial group (ESTD + oral corticosteroids) and the control group (simple ESTD). The incidence of the total esophageal stenosis, intractable esophageal stenosis, the remission rate of dysphagia and the period from the dysphagia present were observed and compared in the two groups.
RESULTS


A total of 101 cases of esophageal ESTD patients were included. There were 48 cases in the trial group, 28 cases of male and 20 cases of female, with an average age of (62.98±7.52) years; 53 cases in the control group, 28 cases of male and 25 cases of female, with an average age of (62.67±8.04) years. The rate of intractable esophageal stenosis in the trial group was lower than that in the control group (6.25% vs. 20.75%,  P <0.05). The average endoscopic treatment times in the non-refractory stenosis patients in the trial group were significantly less than those in the control group 〔(1.85±0.27) times vs. (3.24±0.49) times,  P <0.05〕, and the occurrence time of esophageal stenosis in the trial group was 51.06 d after ESTD, significantly later than that in the control group (29.12 d,  P <0.05).
CONCLUSIONS


Oral corticosteroids can effectively reduce the degree of esophageal stenosis after large area ESTD, as well as the incidence of intractable esophageal stenosis and the number of endoscopic treatment in non-refractory esophageal stenosis patients.",2018,"The rate of intractable esophageal stenosis in the trial group was lower than that in the control group (6.25% vs. 20.75%,  P <0.05).","['48 cases in the trial group, 28 cases of male and 20 cases of female, with an average age of (62.98±7.52) years; 53 cases in the control group, 28 cases of male and 25 cases of female, with an average age of (62.67±8.04) years', 'esophageal stenosis after large area esophageal endoscopic submucosal tunnel dissection (ESTD', 'Esophageal Stenosis after Large Area Endoscopic Submucosal Tunnel Dissection', '101 cases of esophageal ESTD patients were included', 'patients undertook esophageal ESTD were included from January 2014 to January 2018', 'non-refractory esophageal stenosis patients']","['oral corticosteroids', 'Oral Corticosteroids', 'trial group (ESTD + oral corticosteroids']","['rate of intractable esophageal stenosis', 'degree of esophageal stenosis', 'average endoscopic treatment times', 'occurrence time of esophageal stenosis', 'total esophageal stenosis, intractable esophageal stenosis, the remission rate of dysphagia']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014866', 'cui_str': 'Oesophageal stenosis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0014866', 'cui_str': 'Oesophageal stenosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",,0.0219961,"The rate of intractable esophageal stenosis in the trial group was lower than that in the control group (6.25% vs. 20.75%,  P <0.05).","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Shu-Yan', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xiao-Nan', 'Initials': 'XN', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Jun-Chao', 'Initials': 'JC', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Jin-Lin', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Gan', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,[]
2974,32677407,[Pharmacokinetics Study of Phentolamine Mesylate Injection in Healthy Volunteers].,"OBJECTIVE


To study the pharmacokinetic profile of phentolamine mesylate injection in healthy Chinese volunteers.
METHODS


A total of 16 healthy volunteers were randomly divided into two groups, each receiving anterior teeth submucosal infiltration anesthesia and inferior alveolar nerve block anesthesia, respectively. The participants were injected with 0.9 mL, 1.8 mL, and 3.6 mL of 2% lidocaine HCl with 1∶100 000 epinephrine over three periods sequentially, followed by corresponding sequential injection of 0.2 mg, 0.4 mg, 0.8 mg of phentolamine mesylate at the same sites 30 min later.Blood samples were drawn from 5 min before injection to 15 h post the injection of phentolamine mesylate (16 time points). Adverse events were closely observed all the time. Plasma phentolamine mesylate was detected using UPLC-MS/MS with isotope as internal standard. WinNolin 6.1 software was used to calculate the pharmacokinetic parameters.
RESULTS


Time to peak concerntration ( T max ) ranged from 12 to 13 min. Half-time of elimination ( t 1/2 ) ranged from 3.84 to 4.07 h, with a clearance ( CL ) of 190 L/h. Peak concentration ( C max ), area under concentration-time curves from 0 to t hour and from 0 to infinite time ( AUC 0-t  and  AUC 0-∞ ) increased proportionally in the dose range of 0.2 mg to 0.8 mg. The results of confidence interval analysis showed nearly linear dynamic characteristics for the injection of phentolamine mesylate. All participants experienced mild adverse events, including pain at the injection point, dizziness, and palpitations. These adverse events disappeared without treatments.
CONCLUSIONS


Phentolamine mesylate injection is effective for reversing oral local anesthetic effects.",2018,The results of confidence interval analysis showed nearly linear dynamic characteristics for the injection of phentolamine mesylate.,"['Healthy Volunteers', '16 healthy volunteers', 'healthy Chinese volunteers']","['Phentolamine mesylate injection', 'phentolamine mesylate', 'phentolamine mesylate injection', 'anterior teeth submucosal infiltration anesthesia and inferior alveolar nerve block anesthesia', 'lidocaine HCl with 1∶100 000 epinephrine', 'Phentolamine Mesylate Injection']","['Adverse events', 'oral local anesthetic effects', 'mild adverse events, including pain at the injection point, dizziness, and palpitations', 'adverse events', 'Time to peak concerntration ( T max ', 'Peak concentration ( C max ), area under concentration-time curves']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0733398', 'cui_str': 'Phentolamine mesylate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C4285977', 'cui_str': 'Inferior alveolar nerve block anaesthesia'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",16.0,0.022249,The results of confidence interval analysis showed nearly linear dynamic characteristics for the injection of phentolamine mesylate.,"[{'ForeName': 'Shi-Bei-Lei', 'Initials': 'SB', 'LastName': 'Lin', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yong-Ping', 'Initials': 'YP', 'LastName': 'Qin', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Shi-Yin', 'Initials': 'SY', 'LastName': 'Feng', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Shi-Qing', 'Initials': 'SQ', 'LastName': 'Shu', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Nan', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Zhu', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Mao-Zhi', 'Initials': 'MZ', 'LastName': 'Liang', 'Affiliation': 'Phase Ⅰ Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,[]
2975,32677452,FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with  FGFR2  rearrangements.,"FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring  FGFR2  fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with  FGFR2  rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life. Clinical Trial Registration: NCT03656536 (ClinicalTrials.gov).",2020,FGFR2,"['patients with advanced CCA with  FGFR2', 'advanced cholangiocarcinoma with  FGFR2  rearrangements', 'patients with previously treated locally advanced/metastatic CCA harboring  FGFR2  fusions/rearrangements']","['gemcitabine\xa0plus cisplatin', 'FGFR2', 'first-line pemigatinib versus gemcitabine plus cisplatin']","['efficacy and safety', 'progression-free survival', 'objective response rate, overall survival, duration of response, disease control rate, safety\xa0and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0493812,FGFR2,"[{'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ\xa085054, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester & Department of Medical Oncology, The Christie Hospital NHS Foundation Trust, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Eric Van', 'Initials': 'EV', 'LastName': 'Cutsem', 'Affiliation': 'Department of Oncology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Department of Oncology and Hematology, Humanitas Clinical and\xa0Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ioka', 'Affiliation': 'Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Melisi', 'Affiliation': 'Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital & Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Research Department of Oncology, UCL Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Department of Medical Oncology, Hammersmith Hospital, Imperial College Health Care Trust, London, UK.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ\xa085054, USA.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'Lihou', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Zhen', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Ekaterine', 'Initials': 'E', 'LastName': 'Asatiani', 'Affiliation': 'Incyte Biosciences International Sàrl, Morges, Switzerland.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Féliz', 'Affiliation': 'Incyte Biosciences International Sàrl, Morges, Switzerland.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}]","Future oncology (London, England)",['10.2217/fon-2020-0429']
2976,32677499,Effects of Simulation Video on Parental Recall of Seizure First Aid: A Quality Improvement Project.,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits. This quality improvement project evaluated if adding a video simulation of seizure first aid improved parental recall. Parents of children with seizures were randomized to standard verbal counseling or video group, which were shown a video simulation of seizure first aid. All families also received a standardized written action plan. Eighty-three patients were randomized from July to October 2018. Overall, 53% of families who received standard counseling accurately recalled seizure first aid compared with 31% in video group (χ 2  = 3.24,  P  = .07). Among families without baseline knowledge of seizure first aid, 43% in the standard counseling group recalled accurately compared with 16% of video group (χ 2  = 4.52,  P  = .03). These results underscore the importance of face-to-face patient education despite the popularity of video-based media. Future Plan-Do-Study-Act cycles will include piloting a hands-on seizure first aid simulation with mannequins.",2020,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits.","['Parents of children with seizures', 'Eighty-three patients were randomized from July to October 2018']","['Simulation Video', 'standard verbal counseling or video group']",['Parental Recall of Seizure First Aid'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016143', 'cui_str': 'First aid'}]",83.0,0.0518988,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits.","[{'ForeName': 'Xinran Maria', 'Initials': 'XM', 'LastName': 'Xiang', 'Affiliation': 'Louisiana State University Health Sciences Center, New Orleans, LA, USA.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Louisiana State University Health Sciences Center, New Orleans, LA, USA.'}]",Journal of child neurology,['10.1177/0883073820939390']
2977,32677514,Plasma Technology Reduces Blood Loss in Adolescent Idiopathic Scoliosis Surgery: A Prospective Randomized Clinical Trial.,"STUDY DESIGN


Prospective randomized clinical trial.
OBJECTIVES


To assess the effectiveness of PEAK Plasmablade (PPB), compared with bipolar sealer and standard electrocautery, in the posterior spinal instrumentation and fusion (PSF) surgery performed for adolescent idiopathic scoliosis (AIS).
METHODS


Ninety-three patients undergoing PSF surgery for AIS were randomized in 2 groups: group-A patients (n = 45) underwent PSF surgery using PPB; group-B patients (n = 48) were treated with bipolar sealer and standard electrocautery. Demographic and surgical data was recorded. All the patients underwent serial blood tests on the day before surgery (T0) and at 24 (T1), 48 (T2), 72 (T3), and 96 (T4) hours postoperatively. Visual analogue scale for pain (VAS) score, the percentage of paracetamol assumption, and the blood transfusion rate were recorded in the time-lapse T1 to T4. Intergroup variability was assessed. Pearson correlation test was performed. A  P  value <.05 was considered significant.
RESULTS


In group A, a significantly shorter total operative time ( P  = .0087), a significantly lower total intraoperative blood loss (TBL) ( P  = .001), and a higher postoperative hemoglobin (Hb) ( P  = .01) were recorded. A significant higher mean Hb concentration and mean albumin value was recorded in group A at 24 and 48 hours postoperatively. A significant correlation between TBL and hospital stay was recorded in both groups (group A,  P  = .00 001; group B,  P  = .00 006); moreover, in both groups, a significant correlation was observed between TBL and mean VAS at 72 hours postoperatively (group A,  P  = .0009; group B,  P  = .0001) and at 96 hours postoperatively (group A,  P  = .000 044; group B,  P  = .00 001).
CONCLUSIONS


PPB reduces the intraoperative blood loss in PSF performed for AIS, thus allowing a patient's faster recovery.",2020,"In group A, a significantly shorter total operative time ( P  = .0087), a significantly lower total intraoperative blood loss (TBL) ( P  = .001), and a higher postoperative hemoglobin (Hb) ( P  = .01) were recorded.","['Ninety-three patients undergoing PSF surgery for AIS', 'adolescent idiopathic scoliosis (AIS', 'Adolescent Idiopathic Scoliosis Surgery']","['PEAK Plasmablade (PPB', 'posterior spinal instrumentation and fusion (PSF) surgery', 'PSF surgery using PPB', 'Plasma Technology', 'bipolar sealer and standard electrocautery']","['TBL and hospital stay', 'TBL and mean VAS', 'Visual analogue scale for pain (VAS) score, the percentage of paracetamol assumption, and the blood transfusion rate', 'mean Hb concentration and mean albumin value', 'total operative time', 'total intraoperative blood loss (TBL', 'intraoperative blood loss', 'higher postoperative hemoglobin (Hb']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589058', 'cui_str': 'Posterior spinal instrumentation'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0589058', 'cui_str': 'Posterior spinal instrumentation'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",93.0,0.0446177,"In group A, a significantly shorter total operative time ( P  = .0087), a significantly lower total intraoperative blood loss (TBL) ( P  = .001), and a higher postoperative hemoglobin (Hb) ( P  = .01) were recorded.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Piazzolla', 'Affiliation': 'University of Bari ""Aldo Moro""-AOU Policlinico Consorziale, Bari, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bizzoca', 'Affiliation': 'University of Bari ""Aldo Moro""-AOU Policlinico Consorziale, Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Solarino', 'Affiliation': 'University of Bari ""Aldo Moro""-AOU Policlinico Consorziale, Bari, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Parato', 'Affiliation': 'University of Bari ""Aldo Moro""-AOU Policlinico Consorziale, Bari, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Moretti', 'Affiliation': 'University of Bari ""Aldo Moro""-AOU Policlinico Consorziale, Bari, Italy.'}]",Global spine journal,['10.1177/2192568220928344']
2978,32677614,Prospective Randomized Trial Comparing Mitomycin C Combined with Ologen Implant versus Mitomycin C Alone as Adjuvants in Trabeculectomy.,"PURPOSE


Comparative evaluation of trabeculectomy with mitomycin C (MMC) versus trabeculectomy with MMC plus Ologen (Aeon Astron Europe, Leiden, The Netherlands).
DESIGN


Prospective, randomized, comparative study.
PARTICIPANTS


Fifty eyes of 50 patients with primary open-angle glaucoma or pseudophakic primary angle-closure glaucoma were recruited.
METHODS


Twenty-five eyes underwent trabeculectomy with low-dose MMC alone (0.1 mg/ml for 1 minute; MMC group) and 25 eyes underwent trabeculectomy with low-dose MMC plus Ologen (Ologen group) at a tertiary eye care center. Only patients with minimum follow-up of 12 months were included in the study.
MAIN OUTCOME MEASURES


Percentage reduction in intraocular pressure (IOP). Secondary outcome measures included percentage of patients achieving absolute and qualified success for IOP of less than 15 mmHg and less than 18 mmHg, bleb morphological features, need for antiglaucoma medications, and rate of complications.
RESULTS


The mean preoperative IOP was 25.96±4.82 mmHg and 26.32±4.27 mmHg in the MMC and Ologen groups, respectively (P = 0.81). Mean postoperative IOP at 12 months was 11.33±3.18 mmHg in the MMC group and 14.35±3.34 mmHg in the Ologen group (P < 0.001 at all visits in both the groups). Significantly higher IOP reduction was noted in the MMC group at both 6 months (56.9% vs. 47.1%; P = 0.035) and 12 months (55% vs. 44.2%; P = 0.019). Cumulative success (absolute plus qualified success) was achieved in 86.3% of eyes in the MMC group compared with 73.9% of eyes in the Ologen group (P = 0.46) when IOP of 15 mmHg or less was considered as the definition of success.
CONCLUSIONS


The addition of a biodegradable collagen implant (Ologen) does not improve efficacy of MMC-augmented trabeculectomy in primary adult glaucomas.",2018,The addition of a biodegradable collagen implant (Ologen) does not improve efficacy of MMC-augmented trabeculectomy in primary adult glaucomas.,"['Twenty-five eyes underwent', 'Fifty eyes of 50 patients with primary open-angle glaucoma or pseudophakic primary angle-closure glaucoma were recruited', 'Only patients with minimum follow-up of 12 months were included in the study']","['trabeculectomy with MMC plus Ologen', 'trabeculectomy with low-dose MMC plus Ologen', 'trabeculectomy with mitomycin C (MMC', 'trabeculectomy with low-dose MMC alone ', 'biodegradable collagen implant (Ologen', 'Mitomycin C Combined with Ologen Implant versus Mitomycin C Alone', 'MMC-augmented trabeculectomy', 'MMC']","['Mean postoperative IOP', 'Cumulative success', 'mean preoperative IOP', 'percentage of patients achieving absolute and qualified success for IOP of less than 15 mmHg and less than 18 mmHg, bleb morphological features, need for antiglaucoma medications, and rate of complications', 'IOP reduction', 'intraocular pressure (IOP']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0056114', 'cui_str': 'collagen-glycosaminoglycan copolymer'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0590992', 'cui_str': 'Collagen implant'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",50.0,0.150654,The addition of a biodegradable collagen implant (Ologen) does not improve efficacy of MMC-augmented trabeculectomy in primary adult glaucomas.,"[{'ForeName': 'Mrittika', 'Initials': 'M', 'LastName': 'Sen', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Midha', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Talvir', 'Initials': 'T', 'LastName': 'Sidhu', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dewang', 'Initials': 'D', 'LastName': 'Angmo', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramanjit', 'Initials': 'R', 'LastName': 'Sihota', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Tanuj', 'Initials': 'T', 'LastName': 'Dada', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: tanujdada@gmail.com.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2018.07.003']
2979,32677699,Role of drug-associated environmental stimuli in the development of cross-tolerance to the tachycardic effects of nicotine and alcohol in humans.,"According to the Pavlovian conditioning model, drug tolerance is modulated by drug-associated environmental cues. This study evaluated the contribution of drug-associated cues in the development of cross-tolerance to the tachycardic effects of nicotine from tobacco and alcohol in human subjects. Forty undergraduate students were recruited for this experiment, and each student was randomly assigned to one of two experimental conditions. Twenty students smoked nicotine-containing cigarettes in context A and placebo cigarettes in context B, and twenty students smoked nicotine-containing cigarettes in context B and placebo cigarettes in context A. A cross-tolerance test was carried out by dividing the subjects in each condition into two subgroups (n = 10). Each subgroup consumed alcohol in both contexts (A and B). The results of this experiment showed that cross-tolerance between nicotine and alcohol was exhibited only if the cross-tolerance test was carried out in the same context where tolerance had developed to the nicotine from tobacco. These results support the hypothesis that drug-associated environmental stimuli play a modulatory role in the development of cross-tolerance between nicotine from tobacco and alcohol.",2020,The results of this experiment showed that cross-tolerance between nicotine and alcohol was exhibited only if the cross-tolerance test was carried out in the same context where tolerance had developed to the nicotine from tobacco.,"['Twenty students smoked nicotine-containing cigarettes in context A and placebo cigarettes in context B, and twenty students smoked', 'Forty undergraduate students', 'human subjects', 'humans']","['nicotine-containing cigarettes in context B and placebo cigarettes', 'nicotine']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],40.0,0.0259449,The results of this experiment showed that cross-tolerance between nicotine and alcohol was exhibited only if the cross-tolerance test was carried out in the same context where tolerance had developed to the nicotine from tobacco.,"[{'ForeName': 'Rosa Isela', 'Initials': 'RI', 'LastName': 'Ruiz-García', 'Affiliation': 'Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México. iselaruiz@unam.mx.'}, {'ForeName': 'Laura Nayeli', 'Initials': 'LN', 'LastName': 'Cedillo Zavaleta', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Jiménez Mejía', 'Affiliation': ''}, {'ForeName': 'Florencio', 'Initials': 'F', 'LastName': 'Miranda Herrera', 'Affiliation': ''}]",Adicciones,['10.20882/adicciones.1385']
2980,32677851,Breathing-focused Yoga as Augmentation for Unipolar and Bipolar Depression: A Randomized Controlled Trial: Le yoga axé sur la respiration comme traitement d'appoint pour la dépression unipolaire et bipolaire: Un essai randomisé contrôlé.,"OBJECTIVE


Patients with depression frequently experience persistent residual symptoms even with optimal interventions. These patients often use complementary treatments, including yoga, as a preferred alternative or adjunctive treatment. There is evidence for the benefit of yoga for depression, but this has not been rigorously evaluated, particularly in bipolar depression. We aimed to determine the feasibility and benefit of manualized breathing-focused yoga in comparison to psychoeducation as augmentation to pharmacotherapy for improving residual symptoms of depression in unipolar and bipolar patients.
METHODS


Using a randomized single-blind crossover design, 72 outpatients with unipolar or bipolar depression were augmented with the two 8-week interventions at separate times, as add-ons to current first-line antidepressants and mood stabilizers. The primary outcome measure was the Montgomery-Åsberg Depression Rating Scale (MADRS). Due to the high dropout of participants after crossover at Week 8, analysis focused on between-group comparisons of yoga and psychoeducation during the initial 8 weeks of the study.
RESULTS


There was a significant decline in depressive symptoms, as measured by the MADRS, following 8 weeks of yoga. However, there was no significant difference in MADRS ratings between intervention groups. Similar improvements in self-rated depressive symptoms and well-being were also observed across time.
CONCLUSIONS


Both yoga and psychoeducation may improve residual symptoms of unipolar and bipolar depression as add-on to medications. In-class group sessions and long study durations may reduce feasibility for this population. Larger trials with parallel group design and shorter duration may be more feasible.",2020,"There was a significant decline in depressive symptoms, as measured by the MADRS, following 8 weeks of yoga.","['Patients with depression frequently experience persistent residual symptoms even with optimal interventions', '72 outpatients with unipolar or bipolar depression', 'unipolar and bipolar patients', 'Unipolar and Bipolar Depression']","['Breathing-focused Yoga as Augmentation', 'manualized breathing-focused yoga']","['MADRS ratings', 'residual symptoms of unipolar and bipolar depression', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'self-rated depressive symptoms', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",72.0,0.0717722,"There was a significant decline in depressive symptoms, as measured by the MADRS, following 8 weeks of yoga.","[{'ForeName': 'Arun V', 'Initials': 'AV', 'LastName': 'Ravindran', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Martha S', 'Initials': 'MS', 'LastName': 'McKay', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'da Silva', 'Affiliation': 'Institute of Medical Science, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Tindall', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Garfinkel', 'Affiliation': 'Native Child and Family Services of Toronto, Ontario, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Paric', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Ravindran', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720940535']
2981,32677876,Intra-articular injections of allogeneic human adipose-derived mesenchymal progenitor cells in patients with symptomatic bilateral knee osteoarthritis: a Phase I pilot study.,"Aim:  This study investigated the safety and clinical outcomes of expanded allogeneic human adipose-derived mesenchymal progenitor cells injected into patients with symptomatic, bilateral knee osteoarthritis.  Design:  In this single-site, randomized, double-blind, dose-ranging, Phase I study, patients were randomized to three treatment groups (low dose, 1 × 10 7  cells; medium dose, 2 × 10 7  cells; high dose, 5 × 10 7  cells). All patients received two bilateral intra-articular injections: week 0 (baseline) and week 3. The primary end point was adverse events within 48 weeks. Secondary end points were measured with Western Ontario and McMaster Universities Osteoarthritis index, visual analog scale, short form-36 at weeks 12, 24 and 48. Quantitative MRI measurements of cartilage volume were compared from baseline and week 48.  Results:  A total of 22 subjects were enrolled of which 19 (86%) completed the study. Adverse events were transient, including mild to moderate pain and swelling of injection site. Improvements from baseline were measured in the secondary end points. MRI assessments showed slight improvements in the low-dose group.  Conclusion:  Safety and improvements in pain and function after intra-articular injections of allogeneic human adipose-derived mesenchymal progenitor cells into arthritic patients was demonstrated.",2020,"Secondary end points were measured with Western Ontario and McMaster Universities Osteoarthritis index, visual analog scale, short form-36 at weeks 12, 24 and 48.","['arthritic patients', 'A total of\xa022 subjects were enrolled of which\xa019 (86%) completed the study', 'patients with symptomatic, bilateral knee osteoarthritis', 'patients with symptomatic bilateral knee osteoarthritis']","['allogeneic human adipose-derived mesenchymal progenitor cells', 'expanded allogeneic human adipose-derived mesenchymal progenitor cells']","['Quantitative MRI measurements of cartilage volume', 'pain and function', 'adverse events', 'Western Ontario and McMaster Universities Osteoarthritis index, visual analog scale, short form-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C3535670', 'cui_str': 'human adipose preparation'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",22.0,0.457349,"Secondary end points were measured with Western Ontario and McMaster Universities Osteoarthritis index, visual analog scale, short form-36 at weeks 12, 24 and 48.","[{'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai 200001, PR\xa0China.'}, {'ForeName': 'Chengxiang', 'Initials': 'C', 'LastName': 'Dai', 'Affiliation': 'Cellular Biomedicine Group, 333 Guiping Road, Bldg 1, 6th FI, Shanghai 200233, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai 200001, PR\xa0China.'}, {'ForeName': 'Suke', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Cellular Biomedicine Group, 333 Guiping Road, Bldg 1, 6th FI, Shanghai 200233, PR China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': 'Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai 200001, PR\xa0China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Cellular Biomedicine Group, 333 Guiping Road, Bldg 1, 6th FI, Shanghai 200233, PR China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Cellular Biomedicine Group, 333 Guiping Road, Bldg 1, 6th FI, Shanghai 200233, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai 200001, PR\xa0China.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Togashi', 'Affiliation': 'Department of Orthopaedic Surgery, Keck School of Medicine, The University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'C Thomas', 'Initials': 'CT', 'LastName': 'Vangsness', 'Affiliation': 'Department of Orthopaedic Surgery, Keck School of Medicine, The University of Southern California, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Chunde', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai 200001, PR\xa0China.'}]",Regenerative medicine,['10.2217/rme-2019-0106']
2982,32677891,Non-inferiority comparative clinical trial between early oral REFEEDING and usual oral REFEEDING in predicted mild acute biliary pancreatitis.,"BACKGROUND


The aim of the study was to compare the onset of oral feeding in the first 24 h after hospital admission with usual oral refeeding and determine whether the timing of the onset of oral feeding influences the recurrence of pain or alters the blood levels of pancreatic enzymes in patients with predicted mild acute biliary pancreatitis.
METHODS


This non-inferiority randomized controlled trial was carried out between September 2018 and June 2019 after receiving authorization from the ethics committee for health research. Patients with a diagnosis of predicted mild acute biliary pancreatitis were divided into Group A (early oral refeeding, EOR) and Group B (usual oral refeeding, UOR). Outcome measures included pancreatic lipase levels, the systemic inflammatory response (concentrations of leukocytes), feasibility (evaluated by abdominal pain recurrence), the presence and recurrence of gastrointestinal symptoms and the length of hospital stay.
RESULTS


Two patients in the EOR group experienced pain relapse (3.2%), and four patients in the UOR group experienced pain relapse (6.77%) after oral refeeding (p = 0.379). The presence of nausea or vomiting after the onset of oral refeeding was not different between the two groups (p = 0.293). The onset of oral refeeding was approximately 48 h later in the UOR group. The length of hospital stay was 5 days in the EOR group and 8 days in the UOR group (p = 0.042), and this difference was also manifested in higher hospital costs in the UOR group (p = 0.0235).
CONCLUSION


Compared with usual oral refeeding, early oral refeeding is safe in predicted mild acute biliary pancreatitis patients, does not cause adverse gastrointestinal events, and reduces the length of hospital stay and costs.
TRIAL REGISTRATION


Early oral refeeding in mild acute pancreatitis (EORVsUOR). NCT04168801 , retrospectively registered (November 19, 2019).",2020,"Compared with usual oral refeeding, early oral refeeding is safe in predicted mild acute biliary pancreatitis patients, does not cause adverse gastrointestinal events, and reduces the length of hospital stay and costs.
","['patients with predicted mild acute biliary pancreatitis', 'predicted mild acute biliary pancreatitis', 'September 2018 and June 2019 after receiving authorization from the ethics committee for health research', 'mild acute biliary pancreatitis patients', 'Patients with a diagnosis of predicted mild acute biliary pancreatitis', 'mild acute pancreatitis (EORVsUOR']",[],"['higher hospital costs', 'pancreatic lipase levels, the systemic inflammatory response (concentrations of leukocytes), feasibility (evaluated by abdominal pain recurrence), the presence and recurrence of gastrointestinal symptoms and the length of hospital stay', 'length of hospital stay and costs', 'nausea or vomiting', 'pain relapse', 'length of hospital stay', 'onset of oral refeeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0747195', 'cui_str': 'Biliary pancreatitis'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0443469', 'cui_str': 'Pancreatic lipase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",,0.124806,"Compared with usual oral refeeding, early oral refeeding is safe in predicted mild acute biliary pancreatitis patients, does not cause adverse gastrointestinal events, and reduces the length of hospital stay and costs.
","[{'ForeName': 'Edgard Efrén', 'Initials': 'EE', 'LastName': 'Lozada-Hernández', 'Affiliation': 'Department of Surgery and Clinical Research, Hospital Regional de Alta Especialidad del Bajío, Circuito Quinta los Naranjos # 145 B. Colonia Quinta los Naranjos, León, Guanajuato, Mexico. edgardlozada@hotmail.com.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Barrón-González', 'Affiliation': 'Department of Surgery, Unidad Médica de Alta Especialidad Bajío, Instituto Mexicano del Seguro Social, León, Guanajuato, Mexico.'}, {'ForeName': 'Santa', 'Initials': 'S', 'LastName': 'Vázquez-Romero', 'Affiliation': 'Department of Surgery, Unidad Médica de Alta Especialidad Bajío, Instituto Mexicano del Seguro Social, León, Guanajuato, Mexico.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Cano-Rosas', 'Affiliation': 'Department of Surgery, Unidad Médica de Alta Especialidad Bajío, Instituto Mexicano del Seguro Social, León, Guanajuato, Mexico.'}, {'ForeName': 'Evelia', 'Initials': 'E', 'LastName': 'Apolinar-Jimenez', 'Affiliation': 'Department of Clinical Nutrition, Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, Mexico.'}]",BMC gastroenterology,['10.1186/s12876-020-01363-3']
2983,32677897,Effects of a 16-week multimodal exercise program on gait performance in individuals with dementia: a multicenter randomized controlled trial.,"BACKGROUND


There is a high prevalence of gait impairments in individuals with dementia (IWD). Gait impairments are associated with increased risk of falls, disability, and economic burden for health care systems. Only few studies have investigated the effectiveness of physical activity on gait performance in IWD, reporting promising but inconsistent results. Thus, this study aimed to investigate the effectiveness of a multimodal exercise program (MEP) on gait performance in IWD.
METHODS


In this parallel-group randomized controlled trial, we enrolled 319 IWD of mild to moderate severity, living in care facilities, aged ≥ 65 years, and being able to walk at least 10 m. The control group (n = 118) received conventional treatment, whereas the intervention group (n = 201) additionally participated in a 16-week MEP specifically tailored to IWD. We examined the effects of the MEP on spatiotemporal gait parameters and dual task costs by using the gait analysis system GAITRite. Additionally, we compared characteristics between positive, non-, and negative responders, and investigated the impact of changes in underlying motor and cognitive performance in the intervention group by conducting multiple regression analyses.
RESULTS


Two-factor analyses of variance with repeated measurements did not reveal any statistically significant time*group effects on either spatiotemporal gait parameters or dual task costs. Differences in baseline gait performance, mobility, lower limb strength, and severity of cognitive impairments were observed between positive, non-, and negative responders. Positive responders were characterized by lower motor performance compared to negative and non-responders, while non-responders showed better cognitive performance than negative responders. Changes in lower limb strength and function, mobility, executive function, attention, and working memory explained up to 39.4% of the variance of changes in gait performance.
CONCLUSIONS


The effectiveness of a standardized MEP on gait performance in IWD was limited, probably due to insufficient intensity and amount of specific walking tasks as well as the large heterogeneity of the sample. However, additional analyses revealed prerequisites of individual characteristics and impacts of changes in underlying motor and cognitive performance. Considering such factors may improve the effectiveness of a physical activity intervention among IWD.
TRIAL REGISTRATION


DRKS00010538 (German Clinical Trial Register, date of registration: 01 June 2016, retrospectively registered, https://www.drks.de/drks_web/setLocale_EN.do ).",2020,"Positive responders were characterized by lower motor performance compared to negative and non-responders, while non-responders showed better cognitive performance than negative responders.","['individuals with dementia', 'enrolled 319 IWD of mild to moderate severity, living in care facilities, aged ≥ 65\u2009years, and being able to walk at least 10\u2009m', 'individuals with dementia (IWD', '01 June 2016, retrospectively registered, https://www.drks.de/drks_web/setLocale_EN.do ']","['multimodal exercise program (MEP', 'multimodal exercise program', 'standardized MEP', 'MEP', 'conventional treatment, whereas the intervention group (n\u2009=\u2009201) additionally participated in a 16-week MEP specifically tailored to IWD']","['lower limb strength and function, mobility, executive function, attention, and working memory', 'cognitive performance', 'baseline gait performance, mobility, lower limb strength, and severity of cognitive impairments', 'gait performance', 'spatiotemporal gait parameters and dual task costs', 'spatiotemporal gait parameters or dual task costs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0856538', 'cui_str': 'Living in care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0744723,"Positive responders were characterized by lower motor performance compared to negative and non-responders, while non-responders showed better cognitive performance than negative responders.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Trautwein', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany. sandra.trautwein@kit.edu.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Barisch-Fritz', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Scharpf', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Ringhof', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Stein', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Krell-Roesch', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Woll', 'Affiliation': 'Karlsruhe Institute of Technology, Institute of Sports and Sports Science, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-01635-3']
2984,32674419,Impact of an Educational Program on Behavioral Changes toward Environmental Health among Laotian Students.,"This study evaluates the effect of an integrated health care educational program on several behavioral changes related to environmental health among Laotian students. Students in the experimental group received education concerning environmental health-related issues, including air pollution and chemical exposure. Analyses of covariance (ANCOVA) and paired  t -tests were conducted for the statistical analysis of the pre- and post-survey scores. The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores. Moreover, in the experimental group, the girls' risk perception scores significantly increased after receiving the education, which was not observed in the control group. The risk perception score among non-drinking students also significantly increased after the program. These results indicate that the education program effectively enhanced the students' risk perception, especially that of girls and nondelinquent students.",2020,The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores.,"['Laotian Students', 'Laotian students']","['education concerning environmental health-related issues, including air pollution and chemical exposure', 'Educational Program', 'integrated health care educational program']","['risk perception score', 'risk perception and information-seeking behaviors towards air pollution and chemical exposure', ""students' risk perception"", ""girls' risk perception scores"", 'Behavioral Changes toward Environmental Health']","[{'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014413', 'cui_str': 'Health, Environmental'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0678803', 'cui_str': 'Chemical exposure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0596775', 'cui_str': 'Information Seeking Behavior'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0678803', 'cui_str': 'Chemical exposure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0014413', 'cui_str': 'Health, Environmental'}]",,0.0119297,The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores.,"[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Department of Occupational and Environmental Medicine, College of Medicine, Ewha Womans University, Seoul 07804, Korea.'}, {'ForeName': 'Harris Hyun-Soo', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Sociology, College of Social Sciences, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Eun Mee', 'Initials': 'EM', 'LastName': 'Kim', 'Affiliation': 'Department of International Studies, Graduate School of International Studies, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Yookyung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Kinesiology & Sports Studies, College of Science and Industry Convergence, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Ha', 'Affiliation': 'Department of Occupational and Environmental Medicine, College of Medicine, Ewha Womans University, Seoul 07804, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17145055']
2985,32480361,Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study.,"BACKGROUND


Recent advancements in wearable sensor technology have shown the feasibility of remote physical therapy at home. In particular, the current COVID-19 pandemic has revealed the need and opportunity of internet-based wearable technology in future health care systems. Previous research has shown the feasibility of human activity recognition technologies for monitoring rehabilitation activities in home environments; however, few comprehensive studies ranging from development to clinical evaluation exist.
OBJECTIVE


This study aimed to (1) develop a home-based rehabilitation (HBR) system that can recognize and record the type and frequency of rehabilitation exercises conducted by the user using a smartwatch and smartphone app equipped with a machine learning (ML) algorithm and (2) evaluate the efficacy of the home-based rehabilitation system through a prospective comparative study with chronic stroke survivors.
METHODS


The HBR system involves an off-the-shelf smartwatch, a smartphone, and custom-developed apps. A convolutional neural network was used to train the ML algorithm for detecting home exercises. To determine the most accurate way for detecting the type of home exercise, we compared accuracy results with the data sets of personal or total data and accelerometer, gyroscope, or accelerometer combined with gyroscope data. From March 2018 to February 2019, we conducted a clinical study with two groups of stroke survivors. In total, 17 and 6 participants were enrolled for statistical analysis in the HBR group and control group, respectively. To measure clinical outcomes, we performed the Wolf Motor Function Test (WMFT), Fugl-Meyer Assessment of Upper Extremity, grip power test, Beck Depression Inventory, and range of motion (ROM) assessment of the shoulder joint at 0, 6, and 12 months, and at a follow-up assessment 6 weeks after retrieving the HBR system.
RESULTS


The ML model created with personal data involving accelerometer combined with gyroscope data (5590/5601, 99.80%) was the most accurate compared with accelerometer (5496/5601, 98.13%) or gyroscope data (5381/5601, 96.07%). In the comparative study, the drop-out rates in the control and HBR groups were 40% (4/10) and 22% (5/22) at 12 weeks and 100% (10/10) and 45% (10/22) at 18 weeks, respectively. The HBR group (n=17) showed a significant improvement in the mean WMFT score (P=.02) and ROM of flexion (P=.004) and internal rotation (P=.001). The control group (n=6) showed a significant change only in shoulder internal rotation (P=.03).
CONCLUSIONS


This study found that a home care system using a commercial smartwatch and ML model can facilitate participation in home training and improve the functional score of the WMFT and shoulder ROM of flexion and internal rotation in the treatment of patients with chronic stroke. This strategy can possibly be a cost-effective tool for the home care treatment of stroke survivors in the future.
TRIAL REGISTRATION


Clinical Research Information Service KCT0004818; https://tinyurl.com/y92w978t.",2020,"The control group (n=6) showed a significant change only in shoulder internal rotation (P=.03).
","['patients with chronic stroke', 'Chronic Stroke Survivors']","['home-based rehabilitation system', 'smartwatch and smartphone app equipped with a machine learning (ML) algorithm', 'Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model', 'home-based rehabilitation (HBR) system']","['internal rotation', 'shoulder internal rotation', 'mean WMFT score', 'functional score of the WMFT and shoulder ROM of flexion and internal rotation', 'ROM of flexion', 'Wolf Motor Function Test (WMFT), Fugl-Meyer Assessment of Upper Extremity, grip power test, Beck Depression Inventory, and range of motion (ROM) assessment of the shoulder joint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}]",,0.0284401,"The control group (n=6) showed a significant change only in shoulder internal rotation (P=.03).
","[{'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Chae', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Republic of Korea.'}, {'ForeName': 'Yushin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Major of Sports Health Rehabilitation, Cheongju University, Cheongju, Republic of Korea.'}, {'ForeName': 'Kyoung-Soub', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Mechanical Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Republic of Korea.'}, {'ForeName': 'Hyung-Soon', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/17216']
2986,32538148,An acute rise of plasma Na +  concentration associates with syndecan-1 shedding during hemodialysis.,"Endothelial dysfunction (ED) contributes to the high incidence of cardiovascular events in patients undergoing hemodialysis. Syndecan-1 in the endothelial glycocalyx can be shed into the circulation, serving as a biomarker for ED. As Na +  is a trigger for glycocalyx shedding, we now tested whether hemodialysis, with higher dialysate Na +  concentrations, is associated with more syndecan-1 shedding compared with standard hemodialysis (SHD). In this crossover study in 29 patients, plasma syndecan-1 was repeatedly measured during SHD and during Hemocontrol hemodialysis (HHD), which is characterized by initially higher dialysate and plasma Na +  levels. Courses of syndecan-1 were compared with linear mixed models. Syndecan-1 shedding was assessed by area under the curve analysis. Plasma Na +  increased early after the start of SHD and HHD, with higher values during HHD (30 min: 142.3 vs. 139.9 mM,  P  < 0.001). Syndecan-1 increased significantly during both conditions, but the percent change was higher (42.9% vs. 19.5%) and occurred earlier (120 vs. 180 min) during HHD. Syndecan-1 levels were significantly higher at 120 min during HHD compared with SHD ( P  < 0.05). Overall, syndecan-1 shedding was higher during HHD compared with SHD (means: 40.4 vs. 19.0 arbitrary units,  P  = 0.06). Lower predialysis plasma Na +  and osmolality were associated with greater intradialytic increases in syndecan-1 levels (both groups,  P  = 0.001). The rise in plasma syndecan-1 levels was more pronounced and occurred earlier during hemodialysis with higher plasma Na +  levels. Although we cannot prove that the rise in plasma syndecan-1 originates from the endothelial glycocalyx, our findings are compatible with Na + -driven endothelial glycocalyx-derived syndecan-1 shedding.",2020,The rise in plasma syndecan-1 levels was more pronounced and occurred earlier during hemodialysis with higher plasma Na +  levels.,"['29 patients, plasma syndecan-1 was repeatedly measured during SHD and during Hemocontrol hemodialysis (HHD), which is characterized by initially higher dialysate and plasma Na +  levels', 'patients undergoing hemodialysis']",[],"['Endothelial dysfunction (ED', 'Lower predialysis plasma Na +  and osmolality', 'syndecan-1 levels', 'plasma syndecan-1 levels', 'syndecan-1 shedding', 'Plasma Na ', 'Syndecan-1 shedding', 'Syndecan-1 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",29.0,0.028535,The rise in plasma syndecan-1 levels was more pronounced and occurred earlier during hemodialysis with higher plasma Na +  levels.,"[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Koch', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Nienke M A', 'Initials': 'NMA', 'LastName': 'Idzerda', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Esmée M', 'Initials': 'EM', 'LastName': 'Ettema', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Kuipers', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dam', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'van den Born', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Casper F M', 'Initials': 'CFM', 'LastName': 'Franssen', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00005.2020']
2987,29961346,Experiences of participating in a client-centred ADL intervention after stroke.,"Background:  This qualitative study was conducted in the context of a client-centred activities of daily living (CADL) intervention aiming to enable agency in daily activities and participation in everyday life after stroke. The intervention was based on the principles of client-centred occupational therapy and then further developed based on empirical research findings. Objective:  To identify what from the clients' perspective characterises the lived experience and meaning of participating in a CADL intervention after stroke. Methods:  The study included 10 persons with stroke who received the intervention and who were able to communicate their experience of participating. Data were collected through two interviews, after the initiation and after the end of the intervention. The analysis was performed using an empirical phenomenological psychological method. Results:  The overall characteristic of the meaning of participating in the intervention was transparency, which was expressed in the participants' experiences of being able to see and follow their own rehabilitation process. An awareness and understanding of their own situation enabled the participants to be actively involved in their rehabilitation. Conclusion:  The intervention contributed to transparency, which appeared to enable and support the client's sense of ownership of daily activities and rehabilitation after stroke.Implications for rehabiliationA client-centred activities of daily living intervention seems to contribute to transparency, where persons with stroke can discover and understand their new ability and situation after stroke.A client-centred rehabilitation situation seems to enable clients to actively engage in their own rehabilitation process.Inviting clients to participate in goal-setting seems to be important in order to create the experience of transparency.Creating continuity in the therapeutic alliance seems to be important in order for the clients to feel trust and experience agency in everyday life.",2019,The intervention was based on the principles of client-centred occupational therapy and then further developed based on empirical research findings.,"['Experiences of participating in a client-centred ADL intervention after stroke', '10 persons with stroke who received the intervention and who were able to communicate their experience of participating']","['daily living (CADL) intervention', 'daily living intervention']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2364293', 'cui_str': 'Able to communicate'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],10.0,0.0166831,The intervention was based on the principles of client-centred occupational therapy and then further developed based on empirical research findings.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ranner', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Guidetti', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'von Koch', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Tham', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1483434']
2988,32673049,An evaluation of fixed and randomized price sequence on the alcohol purchase task.,"Factors influencing drug consumption can be effectively evaluated in the context of behavioral economic demand. Specifically, hypothetical purchase tasks (HPTs) allow for estimated drug consumption at a range of prices in which drug administration is not ethically or feasibly possible. With the marked increase of HPTs in behavioral research, understanding methodological influences on responding is paramount. One such methodological consideration is the price sequence, which can be presented in a fixed, ascending order or a randomized sequence. This study compared fixed and fully randomized sequence order with college student drinkers using a within-subjects design. Self-reported consumption revealed that despite some small differences between the fixed and random sequences, consumption preferences were highly similar, regardless of presentation order. These results suggest participants are likely not anchoring their responses to the prior price on a fixed-order sequence. We conclude with a discussion on how these findings provide implications for HPTs and future research. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Self-reported consumption revealed that despite some small differences between the fixed and random sequences, consumption preferences were highly similar, regardless of presentation order.",['college student drinkers using a within-subjects design'],['hypothetical purchase tasks (HPTs'],[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]",[],[],,0.0361818,"Self-reported consumption revealed that despite some small differences between the fixed and random sequences, consumption preferences were highly similar, regardless of presentation order.","[{'ForeName': 'Allyson R', 'Initials': 'AR', 'LastName': 'Salzer', 'Affiliation': 'Department of Applied Behavioral Science, University of Kansas.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky Medical Center.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Reed', 'Affiliation': 'Department of Applied Behavioral Science, University of Kansas.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000421']
2989,32677486,"A study of the ""Swiss-roll"" folding method for placement of self-gripping mesh in TAPP.","BACKGROUND


Using self-gripping mesh eliminates the need for additional mechanical fixation in laparoscopic groin hernia repair when surgeons plan to fix it. However, the mesh's 'self-gripping' characteristic makes it much more difficult to unfold and place. Here, the novel ""Swiss-roll"" placement method of folding self-gripping mesh is introduced and compared to the common folding placement method.
MATERIAL AND METHODS


The cohort of this prospective randomized controlled study included 100 patients who underwent transabdominal preperitoneal (TAPP) groin hernia repair in the Department of Hernia and Abdominal Wall Surgery of Shanghai East Hospital between January and December 2018. The patients were randomly assigned to the ""Swiss-roll"" folding group or the common folding group. The time required for mesh placement, total surgical duration, and the incidences of postoperative pain and complications were compared.
RESULTS


The times required for mesh placement in the ""Swiss-roll"" and common folding groups were 155.10 ± 48.66 and 202.80 ± 61.05 sec, respectively. The ""Swiss-roll"" folding method significantly shortened the time required for mesh placement ( p  = 0.000). There were no significant differences in total surgical duration and the incidences of postoperative pain and complications between the two groups.
CONCLUSIONS


The ""Swiss-roll"" folding method facilitates self-gripping mesh placement without increasing the incidence of complications and recurrences in TAPP.",2020,"The ""Swiss-roll"" folding method significantly shortened the time required for mesh placement ( p  = 0.000).","['in the Department of Hernia and Abdominal Wall Surgery of Shanghai East Hospital between January and December 2018', '100 patients who underwent']","['Swiss-roll"" folding group or the common folding group', 'transabdominal preperitoneal (TAPP) groin hernia repair']","['postoperative pain and complications', 'total surgical duration', 'time required for mesh placement, total surgical duration, and the incidences of postoperative pain and complications', 'time required for mesh placement']","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0452627', 'cui_str': 'Swiss roll'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",100.0,0.0450798,"The ""Swiss-roll"" folding method significantly shortened the time required for mesh placement ( p  = 0.000).","[{'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Hernia and Abdominal Wall Surgery, Shanghai East Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Jiajie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Hernia and Abdominal Wall Surgery, Shanghai East Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Hernia and Abdominal Wall Surgery, Shanghai East Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Zhengni', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Hernia and Abdominal Wall Surgery, Shanghai East Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Hernia and Abdominal Wall Surgery, Shanghai East Hospital, Tongji University, Shanghai, China.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2020.1780452']
2990,32677707,"Remimazolam Tosilate in Upper Gastrointestinal Endoscopy: A Multicenter, Randomized, Non-inferiority, Phase III Trial.","BACKGROUND AND AIM


Remimazolam Tosilate (RT) is a new short-acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy.
METHODS


This positive-controlled, non-inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety.
RESULTS


The success rate of sedation in RT group was non-inferior to that in propofol group (97.34% vs. 100.00%; difference in rate -2.66%, 95% CI -4.96 to -0.36, meeting criteria for non-inferiority). Patients in RT group had longer time to adequate sedation (p<0.0001), but shorter time to fully alert (p<0.0001) than that in propofol group. The incidences of hypotension (13.04% vs. 42.86%, p<0.0001), treatment-related hypotension (0.54% vs. 5.82%, p<0.0001) and respiratory depression (1.09% vs. 6.88%, p=0.0 064) were significantly lower in RT group. AEs were reported in 74 (39.15%) patients in RT group and 114 (60.32%) patients in propofol group, with significant difference (p<0.0001).
CONCLUSION


This trial established non-inferior sedation success rate of RT compared with propofol. RT allows faster recovery from sedation compared with propofol. The safety profile is favorable and appears to be superior to propofol, indicating that it was feasible and well tolerated for patients.",2020,"The incidences of hypotension (13.04% vs. 42.86%, p<0.0001), treatment-related hypotension (0.54% vs. 5.82%, p<0.0001) and respiratory depression (1.09% vs. 6.88%, p=0.0 064) were significantly lower in RT group.","['384 patients scheduled to undergo upper gastrointestinal endoscopy', 'patients undergoing upper gastrointestinal endoscopy', 'in Upper Gastrointestinal Endoscopy', 'patients at 17 centers, between September 2017 and November 2017']","['Remimazolam Tosilate', 'propofol', 'RT', 'RT with propofol', 'RT or propofol']","['success rate of sedation', 'shorter time to fully alert', 'respiratory depression', 'efficacy and safety', 'treatment-related hypotension', 'Adverse events (AEs', 'longer time to adequate sedation', 'incidences of hypotension']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",384.0,0.115255,"The incidences of hypotension (13.04% vs. 42.86%, p<0.0001), treatment-related hypotension (0.54% vs. 5.82%, p<0.0001) and respiratory depression (1.09% vs. 6.88%, p=0.0 064) were significantly lower in RT group.","[{'ForeName': 'Shao-Hui', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical College & Peking Union Medical College Hospital.'}, {'ForeName': 'Tang-Mi', 'Initials': 'TM', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical College & Peking Union Medical College Hospital.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical College & Peking Union Medical College Hospital.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Clinical Pharmacology Research Center, Chinese Academy of Medical College & Peking Union Medical College Hospital.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University.'}, {'ForeName': 'Chu-Xiong', 'Initials': 'CX', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, Beijing TongRen Hospital, Capital Medical University.'}, {'ForeName': 'Hong-Guang', 'Initials': 'HG', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Nanjing First Hospital.'}, {'ForeName': 'Xiao-Ju', 'Initials': 'XJ', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Yijishan Hospital of Wannan Medical College.'}, {'ForeName': 'Fu-Hai', 'Initials': 'FH', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Soochow University.'}, {'ForeName': 'Tai-Di', 'Initials': 'TD', 'LastName': 'Zhong', 'Affiliation': 'Department of Anesthesiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Xi'an Jiaotong University.""}, {'ForeName': 'Jian-Rui', 'Initials': 'JR', 'LastName': 'Lv', 'Affiliation': ""Department of Anesthesiology, The Second Affiliated Hospital of Xi'an Jiaotong University.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital.""}, {'ForeName': 'Yu-Juan', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-sen University.'}, {'ForeName': 'Yong-Hao', 'Initials': 'YH', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Tianjin Medical University General Hospital.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital.'}, {'ForeName': 'Xiang-Kui', 'Initials': 'XK', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Sichuan Provincial People's Hospital.""}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The General Hospital of Northern Theater Command.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Zou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University.'}, {'ForeName': 'Yu-Guang', 'Initials': 'YG', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical College & Peking Union Medical College Hospital.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15188']
2991,32677716,Can prophylactic argon plasma coagulation reduce delayed post-papillectomy bleeding? : A prospective multicenter trial.,"BACKGROUND AND AIM


Endoscopic post-papillectomy bleeding occurs in 3 to 20% of the cases and delayed bleeding is also problematic. However, there is no consensus on how to reduce delayed post-papillectomy bleeding. The aim of this study was to evaluate the efficacy of prophylactic argon plasma coagulation (APC) to minimize delayed bleeding and reduce the persistence of residual tumors after endoscopic papillectomy.
METHODS


In a prospective pilot study of patients with benign ampullary tumors, the prophylactic APC group underwent APC at the resection margin following a conventional snaring papillectomy. Then, 24 hours later after the papillectomy, all patients underwent a follow-up duodenoscopy to identify post-papillectomy bleeding and were followed-up until 12 months. The main outcomes were the delayed (≥ 24 h) post-papillectomy bleeding rate and the tumor persistence rate.
RESULTS


The delayed post-papillectomy bleeding rate was 30.8% (8/26) in the prophylactic APC group and 21.4% (6/28) in the non-APC group (p = 0.434). The post-procedure pancreatitis rates were 23.1% (6/26) and 35.7% (10/28), respectively (p = 0.310). The rate of tumor persistence did not differ between the two groups at one month (12.5% vs. 7.4%, p = 0.656), three months (4.2% vs. 3.7%, p = 1.00), six months (8.3% vs. 3.7%, p = 0.595), and 12 months (0% vs. 3.7%, p = 1.00). There were no procedure-related mortalities or serious complications.
CONCLUSIONS


Prophylactic APC may not be effective in reducing delayed post-papillectomy bleeding or remnant tumor ablation immediately after conventional papillectomy (Clinical trial registration - cris.nih.go.kr; KCT0001955).",2020,Prophylactic APC may not be effective in reducing delayed post-papillectomy bleeding or remnant tumor ablation immediately after conventional papillectomy (Clinical trial registration - cris.nih.go.kr; KCT0001955).,"['patients with benign ampullary tumors, the prophylactic APC group underwent APC at the resection margin following a conventional snaring papillectomy']","['prophylactic APC', 'prophylactic argon plasma coagulation (APC', 'Prophylactic APC']","['post-procedure pancreatitis rates', 'delayed (≥ 24 h) post-papillectomy bleeding rate and the tumor persistence rate', 'delayed post-papillectomy bleeding rate', 'rate of tumor persistence', 'procedure-related mortalities or serious complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0345916', 'cui_str': 'Neoplasm of ampulla of Vater'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0330276,Prophylactic APC may not be effective in reducing delayed post-papillectomy bleeding or remnant tumor ablation immediately after conventional papillectomy (Clinical trial registration - cris.nih.go.kr; KCT0001955).,"[{'ForeName': 'Jae Kook', 'Initials': 'JK', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, SoonChunHyang University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Jong Jin', 'Initials': 'JJ', 'LastName': 'Hyun', 'Affiliation': 'Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, SoonChunHyang University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Yun Nah', 'Initials': 'YN', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, SoonChunHyang University College of Medicine, Bucheon, Republic of Korea.'}, {'ForeName': 'Jung Wan', 'Initials': 'JW', 'LastName': 'Choe', 'Affiliation': 'Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Jin-Seok', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Chang-Il', 'Initials': 'CI', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Seok', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Hong Ja', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, SoonChunHyang University College of Medicine, Bucheon, Republic of Korea.'}, {'ForeName': 'Sang-Heum', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, SoonChunHyang University College of Medicine, Cheonan, Republic of Korea.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15186']
2992,32677772,The efficacy of gonadotropin-releasing hormone (GNRH) agonist before frozen embryo transfer in improving pregnancy outcome and decreasing miscarriage rate in hyperandrogenic polycystic ovary syndrome women: a randomized clinical trial.,"BACKGROUND


The hyper androgenic status is a major complication of PCOS women that deteriorates endometrial function and increases miscarriage rate.
OBJECTIVE


This study was conducted to investigate the efficacy of GnRH agonist before frozenthawed embryo transfer in improving pregnancy outcome in infertile women with PCOS.
MATERIALS & METHODS


This single-blind, randomized controlled trial was performed at Dr Shariati hospital and Omid Fertility Clinic in Tehran, Iran. To do the study, 178 PCOS women were included. Patients were then divided into two groups of control and intervention. All women received the standard treatment for the preparation of the endometrial using estradiol valerate at dose of 6-8 mg/day. The intervention group also received diphereline, as GnRH agonist, at two doses 8 weeks before starting the endometrial preparation.
RESULTS


Chemical pregnancy in intervention group was 47.7% compared to 35.6% in the control group, revealing no significant difference between two groups. No statistically significant difference was observed between two groups concerning clinical pregnancy rate (43.2%vs. 27.3%). However, rate of ongoing pregnancy was42.0% in intervention group but18.0% in thecontrol group, suggesting a significant difference (p =0.001). The rate of miscarriage in the intervention group was 2.6% and in the control group was 33.3% which was significantly lower (p = 0.001).
CONCLUSIONS


It can be concluded that endometrial preparation using GnRH improves ongoing pregnancy and decreases miscarriage rate. It seems that reduction of androgen level in PCOS patients affects the endometrium and improves the re resulting in better pregnancy outcomes by reducing the miscarriage rate.",2020,No statistically significant difference was observed between two groups concerning clinical pregnancy rate (43.2%vs. 27.3%).,"['infertile women with PCOS', 'Dr Shariati hospital and Omid Fertility Clinic in Tehran, Iran', '178 PCOS women were included', 'hyperandrogenic polycystic ovary syndrome women']","['gonadotropin-releasing hormone (GNRH) agonist before frozen embryo transfer', 'GnRH agonist before frozenthawed embryo transfer', 'estradiol valerate', 'diphereline, as GnRH agonist']","['clinical pregnancy rate', 'miscarriage rate', 'rate of miscarriage', 'rate of ongoing pregnancy']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",178.0,0.0986176,No statistically significant difference was observed between two groups concerning clinical pregnancy rate (43.2%vs. 27.3%).,"[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Aghahoseini', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Alyasin', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Samaei-Nouroozi', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hojatollah', 'Initials': 'H', 'LastName': 'Saeidi', 'Affiliation': 'Department of Biology and Embryology, Omid Fertility Center, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shabani-Nashtaei', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Rashidi', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran - S.Rashidi.tums@gmail.com.'}]",Minerva ginecologica,['10.23736/S0026-4784.20.04467-6']
2993,32677911,The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries.,"BACKGROUND


Post-partum haemorrhage (PPH) is a leading cause of maternal death worldwide. The WOMAN trial assessed the effects of tranexamic acid (TXA) on death and surgical morbidity in women with PPH. The trial recorded 483 maternal deaths. We report the circumstances of the women who died.
METHODS


The WOMAN trial recruited 20,060 women with a clinical diagnosis of PPH after a vaginal birth or caesarean section. We randomly allocated women to receive TXA or placebo. When a woman died, we asked participating clinicians to report the cause of death and to provide a short narrative of the events surrounding the death. We collated and edited for clarity the narrative data.
RESULTS


Case fatality rates were 3.0% in Africa and 1.7% in Asia. Nearly three quarters of deaths were within 3 h of delivery and 91% of these deaths were from bleeding. Women who delivered outside a participating hospital (12%) were three times more likely to die (OR = 3.12, 95%CI 2.55-3.81) than those who delivered in hospital. Blood was often unavailable due to shortages or because relatives could not afford to buy it. Clinicians highlighted late presentation, maternal anaemia and poor infrastructure as key contributory factors.
CONCLUSIONS


Although TXA use reduces bleeding deaths by almost one third, mortality rates similar to those in high income countries will not be achieved without tackling late presentation, maternal anaemia, availability of blood for transfusion and poor infrastructure.",2020,"Women who delivered outside a participating hospital (12%) were three times more likely to die (OR = 3.12, 95%CI 2.55-3.81) than those who delivered in hospital.","['women with PPH', 'Women who delivered outside a participating hospital (12%) were three times more likely to die (OR\u2009=\u20093.12, 95%CI 2.55-3.81) than those who delivered in hospital', '483 women following post-partum haemorrhage in developing countries', '20,060 women with a clinical diagnosis of PPH after a vaginal birth or caesarean section']","['tranexamic acid (TXA', 'TXA', 'TXA or placebo']","['mortality rates', 'bleeding deaths', 'death and surgical morbidity', 'Case fatality rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}]",20060.0,0.192909,"Women who delivered outside a participating hospital (12%) were three times more likely to die (OR = 3.12, 95%CI 2.55-3.81) than those who delivered in hospital.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Picetti', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. roberto.picetti@lshtm.ac.uk.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Pepple', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Beaumont', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Eni', 'Initials': 'E', 'LastName': 'Balogun', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Asonganyi', 'Affiliation': 'Maternity Unit, Kumba District Hospital, Kumba, Southwest Province, Cameroon.'}, {'ForeName': 'Rizwana', 'Initials': 'R', 'LastName': 'Chaudhri', 'Affiliation': 'Holy Family Hospital, Gynaecology & Obstetrics Unit 1, F-762 Said Pur Road, Satellite Town, Rawalpindi, Pakistan.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Sheikh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Khartoum, Khartoum, Sudan.'}, {'ForeName': 'Bellington', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Sabaratnam', 'Initials': 'S', 'LastName': 'Arulkumaran', 'Affiliation': ""St George's University of London, Room 1.126, First Floor, Jenner Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03091-8']
2994,32677982,"A prospective, randomized study of Toremifene vs. tamoxifen for the treatment of premenopausal breast cancer: safety and genital symptom analysis.","BACKGROUND


Toremifene (TOR) is a selective oestrogen receptor modulator (SERM) and has comparable efficacy to that of tamoxifen (TAM) in breast cancer patients. Herein, we compared the safety of TOR to that of TAM in the adjuvant treatment of premenopausal breast cancer.
METHODS


This was a prospective randomized and open-label clinical study. Premenopausal patients with hormonal receptor (HR)-positive early breast cancer were randomly assigned (1:1) to receive TOR) or TAM treatment. The follow-up period was 1 year. The primary end point was the incidence of ovarian cysts, and secondary end points were the incidence of endometrial thickening, changes in female hormones, the incidence of fatty liver, changes in the modified Kupperman index (mKMI) and changes in quality of life.
RESULTS


There were 92 patients in the final analysis. The incidences of ovarian cysts were 42.6% in the TOR group and 51.1% in the TAM group (p = 0.441). Forty-one patients (87.2%) in the TOR group and 36 patients (80.0%) in the TAM group experienced endometrial thickening (p = 0.348). The proportions of patients with fatty liver were 31.9% in the TOR group and 26.7% in the TAM group (p = 0.581). No significant differences in the mKMI or quality of life were observed between the two groups.
CONCLUSIONS


TOR and TAM have similar side effects on the female genital system and quality of life in premenopausal early breast cancer patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02344940. Registered 26 January 2015 (retrospectively registered).",2020,The incidences of ovarian cysts were 42.6% in the TOR group and 51.1% in the TAM group (p = 0.441).,"['Premenopausal patients with hormonal receptor (HR)-positive early breast cancer', 'premenopausal early breast cancer patients', 'breast cancer patients', 'Registered 26 January 2015 (retrospectively registered', 'premenopausal breast cancer']","['Toremifene vs. tamoxifen', 'tamoxifen (TAM', 'TOR) or TAM treatment', 'TAM', 'TOR and TAM']","['incidence of ovarian cysts', 'mKMI or quality of life', 'endometrial thickening', 'incidence of endometrial thickening, changes in female hormones, the incidence of fatty liver, changes in the modified Kupperman index (mKMI) and changes in quality of life', 'incidences of ovarian cysts', 'female genital system and quality of life', 'proportions of patients with fatty liver']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0741682', 'cui_str': 'Premenopausal breast cancer'}]","[{'cui': 'C0076836', 'cui_str': 'Toremifene'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0029927', 'cui_str': 'Cyst of ovary'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0743516', 'cui_str': 'Endometrial thickening'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0561431,The incidences of ovarian cysts were 42.6% in the TOR group and 51.1% in the TAM group (p = 0.441).,"[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Siji', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Huang', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Yafen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Xiaosong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.'}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China. kwshen@medmail.com.cn.'}]",BMC cancer,['10.1186/s12885-020-07156-x']
2995,32677987,Establishing cross-systems collaborations for implementation: protocol for a longitudinal mixed methods study.,"BACKGROUND


Cross-system interventions can help integrate services across different service delivery systems but require organizations to establish strong collaborative relationships for implementation. Contingency theory suggests that the effectiveness of different collaborative strategies (i.e. specific ways organizations align operations and services) varies by context. This paper describes a study of different strategies for fostering collaboration between child welfare and substance abuse treatment agencies and the conditions under which they are effective for implementation. We also describe the development and piloting of the Collaborating Across Systems for Program Implementation (CASPI) tool-a decision-making guide intended to help researchers and organizational leaders identify and use appropriate collaborative strategies for their context.
METHODS/DESIGN


This multisite longitudinal, mixed methods study, leverages a naturally occurring implementation initiative -- in up to 17 Ohio counties -- to implement Ohio START (Sobriety Treatment and Reducing Trauma). START is a child welfare model that requires strong collaboration with local substance use treatment organizations to promote integrated services. During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features. We will conduct a convergent mixed methods study drawing on worker surveys, agency documents, administrative data, formal partner agreements, and group interviews. Data will be integrated and analyzed using Qualitative Comparative Analysis (QCA). To develop the CASPI, an expert panel comprised of implementation experts, and community stakeholders will convene to synthesize our findings and develop contents (including a decision tree). During the final year of the study, we will assess the acceptability, appropriateness, and feasibility of the CASPI in a randomized vignette experiment, and a pilot-test with 3 child welfare agencies that have not yet implemented START.
DISCUSSION


Our results will lay the groundwork for a larger controlled trial that will test the CASPI's effectiveness for supporting effective and efficient implementation of cross-system interventions like START. The CASPI is expected to help leaders and researchers select and use collaboration strategies tailored to their context and be applicable in a wide range of settings including rural communities. Our work also advances system-level implementation strategies.
TRIAL REGISTRATION


NCT03931005 , Registered April 29, 2019.",2020,"During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features.",['leverages a naturally occurring implementation initiative -- in up to 17 Ohio counties -- to implement Ohio START (Sobriety Treatment and Reducing Trauma'],[],"['START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features']","[{'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",[],"[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.0363623,"During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features.","[{'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Bunger', 'Affiliation': 'College of Social Work, The Ohio State University, 1947 College Road, Columbus, OH, 43210, USA. Bunger.5@osu.edu.'}, {'ForeName': 'Emmeline', 'Initials': 'E', 'LastName': 'Chuang', 'Affiliation': 'School of Social Welfare, University of California Berkeley, 120 Haviland Hall, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Girth', 'Affiliation': 'John Glenn College of Public Affairs, The Ohio State University, 1810 College Road, Columbus, OH, 43210, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'College of Public Health, The Ohio State University, 1841 Neil Avenue, Columbus, OH, 43210, USA.'}, {'ForeName': 'Fawn', 'Initials': 'F', 'LastName': 'Gadel', 'Affiliation': 'Public Children Services Association of Ohio (PCSAO), 37 West Broad Street, Suite 1100, Columbus, OH, 43215, USA.'}, {'ForeName': 'Marla', 'Initials': 'M', 'LastName': 'Himmeger', 'Affiliation': 'Public Children Services Association of Ohio (PCSAO), 37 West Broad Street, Suite 1100, Columbus, OH, 43215, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saldana', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR, 97405, USA.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'UC San Diego, Department of Psychiatry, 9500 Gilman Drive (0812), La Jolla, San Diego, CA, 92093, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01016-9']
2996,32677992,Safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial: statistical analysis plan.,"BACKGROUND


There is limited evidence that rituximab, a B cell depletion therapy, is an effective treatment for systemic lupus erythematosus (SLE). Data on the mechanisms of B cell depletion in SLE indicate that the combination of rituximab and belimumab may be more effective than rituximab alone. The safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial aims to determine whether belimumab is superior to placebo, when given 4-8 weeks after treatment with rituximab. This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written prior to the end of patient follow-up, while the outcome of the trial is still unknown.
DESIGN AND METHODS


BEAT-LUPUS is a randomised, double-blind, phase II trial of 52 weeks of belimumab versus placebo, initiated 4-8 weeks after rituximab treatment. The primary outcome is anti-dsDNA antibodies at 52 weeks post randomisation. Secondary outcomes include lupus flares and damage, adverse events, doses of concomitant medications, quality of life, and clinical biomarkers. We describe the trial's clinical context, outcome measures, sample size calculation, and statistical modelling strategy, and the supportive analyses planned to evaluate for mediation of the treatment effect through changes in concomitant medication doses and bias from missing data.
DISCUSSION


The analysis will provide detailed information on the safety and effectiveness of belimumab. It will be implemented from July 2020 when patient follow-up and data collection is complete.
TRIAL REGISTRATION


ISRCTN: 47873003 . Registered on 28 November 2016. EudracT: 2015-005543-14 . Registered on 19 November 2018.",2020,"The safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial aims to determine whether belimumab is superior to placebo, when given 4-8 weeks after treatment with rituximab.",[],"['belimumab versus placebo', 'belimumab after B cell depletion therapy', 'rituximab', 'placebo']","['anti-dsDNA antibodies', 'safety and efficacy', 'Safety and efficacy', 'lupus flares and damage, adverse events, doses of concomitant medications, quality of life, and clinical biomarkers']",[],"[{'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1171324', 'cui_str': 'B-cell depletion therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C2747926', 'cui_str': 'Anti-dsDNA antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.396122,"The safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial aims to determine whether belimumab is superior to placebo, when given 4-8 weeks after treatment with rituximab.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Muller', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK. p.muller@ucl.ac.uk.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': 'Rheumatology Research Group, Institute of Inflammation and Ageing (IIA), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Ehrenstein', 'Affiliation': 'Centre for Rheumatology, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}]",Trials,['10.1186/s13063-020-04391-2']
2997,32678053,Report of a Delphi exercise to inform the design of a research programme on screening for thoracic aortic disease.,"OBJECTIVES


To inform the design of a clinical trial of a targeted screening programme for relatives of individuals affected by thoracic aortic disease, we performed a consensus exercise as to the acceptability of screening, the optimal sequence and choice of tests, long-term patient management, and choice of trial design.
METHODS


Working with the Aortic Dissection Awareness UK & Ireland patient association, we performed a Delphi exercise with clinical experts, patients, and carers, consisting of three rounds of consultation followed by a final multi-stakeholder face-to-face workshop.
RESULTS


Thirty-five experts and 84 members of the public took part in the surveys, with 164 patients and clinicians attending the final workshop. There was substantial agreement on the need for a targeted screening pathway that would employ a combined approach (imaging + genetic testing). The target population would include the first- and second-degree adult (> 15 years) relatives, with no upper age limit of affected patients. Disagreement persisted about the screening process, sequence, personnel, the imaging method to adopt, computed tomography (CT) scan vs magnetic resonance imaging (MRI), and the specifics of a potential trial, including willingness to undergo randomisation, and measures of effectiveness and acceptability.
CONCLUSION


A Delphi process, initiated by patients, identified areas of uncertainty with respect to behaviour, process, and the design of a targeted screening programme for thoracic aortic disease that requires further research prior to any future trial.",2020,"A Delphi process, initiated by patients, identified areas of uncertainty with respect to behaviour, process, and the design of a targeted screening programme for thoracic aortic disease that requires further research prior to any future trial.","['Thirty-five experts and 84 members of the public took part in the surveys, with 164 patients and clinicians attending the final workshop', 'relatives of individuals affected by thoracic aortic disease', 'Working with the Aortic Dissection Awareness UK & Ireland patient association']","['targeted screening programme', 'Delphi exercise', 'computed tomography (CT) scan vs magnetic resonance imaging (MRI']",[],"[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0003493', 'cui_str': 'Disorder of aorta'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0340643', 'cui_str': 'Dissection of aorta'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],164.0,0.030268,"A Delphi process, initiated by patients, identified areas of uncertainty with respect to behaviour, process, and the design of a targeted screening programme for thoracic aortic disease that requires further research prior to any future trial.","[{'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Abbasciano', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, LE3 9QP, UK. rga8@leicester.ac.uk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Barwell', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, LE3 9QP, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sayers', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, LE3 9QP, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bown', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, LE3 9QP, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milewicz', 'Affiliation': 'Division of Medical Genetics, Department of Internal Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cooper', 'Affiliation': 'Northern General Hospital, Herries Road, Sheffield, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mariscalco', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, LE3 9QP, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wheeldon', 'Affiliation': 'Northern General Hospital, Herries Road, Sheffield, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fowler', 'Affiliation': '.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Owens', 'Affiliation': '.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, LE3 9QP, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04562-1']
2998,32678054,The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: a subgroup analysis of the Sedation Practice in Intensive Care Evaluation [SPICE III] Trial.,"BACKGROUND


Septic shock is associated with decreased vasopressor responsiveness. Experimental data suggest that central alpha2-agonists like dexmedetomidine (DEX) increase vasopressor responsiveness and reduce catecholamine requirements in septic shock. However, DEX may also cause hypotension and bradycardia. Thus, it remains unclear whether DEX is hemodynamically safe or helpful in this setting.
METHODS


In this post hoc subgroup analysis of the Sedation Practice in Intensive Care Evaluation (SPICE III) trial, an international randomized trial comparing early sedation with dexmedetomidine to usual care in critically patients receiving mechanical ventilation, we studied patients with septic shock admitted to two tertiary ICUs in Australia and Switzerland. The primary outcome was vasopressor requirements in the first 48 h after randomization, expressed as noradrenaline equivalent dose (NEq [μg/kg/min] = noradrenaline + adrenaline + vasopressin/0.4).
RESULTS


Between November 2013 and February 2018, 417 patients were recruited into the SPICE III trial at both sites. Eighty-three patients with septic shock were included in this subgroup analysis. Of these, 44 (53%) received DEX and 39 (47%) usual care. Vasopressor requirements in the first 48 h were similar between the two groups. Median NEq dose was 0.03 [0.01, 0.07] μg/kg/min in the DEX group and 0.04 [0.01, 0.16] μg/kg/min in the usual care group (p = 0.17). However, patients in the DEX group had a lower NEq/MAP ratio, indicating lower vasopressor requirements to maintain the target MAP. Moreover, on adjusted multivariable analysis, higher dexmedetomidine dose was associated with a lower NEq/MAP ratio.
CONCLUSIONS


In critically ill patients with septic shock, patients in the DEX group received similar vasopressor doses in the first 48 h compared to the usual care group. On multivariable adjusted analysis, dexmedetomidine appeared to be associated with lower vasopressor requirements to maintain the target MAP.
TRIAL REGISTRATION


The SPICE III trial was registered at ClinicalTrials.gov ( NCT01728558 ).",2020,Vasopressor requirements in the first 48 h were similar between the two groups.,"['critically ill patients with septic shock, patients in the', 'Intensive Care Evaluation [SPICE\xa0III', 'septic shock', 'patients with septic shock', 'Eighty-three patients with septic shock', 'Between November 2013 and February 2018, 417 patients were recruited into the SPICE III trial at both sites', 'critically patients receiving mechanical ventilation, we studied patients with septic shock admitted to two tertiary ICUs in Australia and Switzerland']","['dexmedetomidine (DEX', 'dexmedetomidine', 'DEX']","['catecholamine requirements', 'hypotension and bradycardia', 'Vasopressor requirements', 'vasopressor responsiveness', 'vasopressor requirements', 'lower NEq/MAP ratio']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037910', 'cui_str': 'Spice'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",83.0,0.380463,Vasopressor requirements in the first 48 h were similar between the two groups.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia. luca.cioccari@insel.ch.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University, Monash Health, Melbourne, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Howe', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Messmer', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Helena K', 'Initials': 'HK', 'LastName': 'Proimos', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Peck', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Tobias M', 'Initials': 'TM', 'LastName': 'Merz', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Takala', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-03115-x']
2999,32678055,"10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head.","BACKGROUND


Avascular necrosis of the femoral head (ANFH) is a severely disabling disease of the hip. Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for the treatment of ANFH, but long-term clinical assessments are lacking. Previously, we reported the 2-year follow-up results of a prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with ANFH. Here, we report the 10-year follow-up results of this study.
METHODS


We recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with or without bone marrow buffy coat (BBC) grafting. Participants underwent follow-up at 24, 60, and 120 months postoperatively. The visual analogue scale (VAS), Lequesne algofunctional index, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores were recorded. Survival rate analysis and prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty.
RESULTS


A total of 31 patients (41 hips) were included in the final analysis. The CD + BBC group had better subjective assessment scores than the CD group. The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029). In the univariate Cox proportional hazards regression model, age [hazard ratio (HR) = 1.079, P = 0.047] and preoperative Ficat stage (HR = 3.283, P = 0.028) indicated a high risk for progression, while the use of BBC (HR = 0.332, P = 0.042) indicated a low risk. Preoperative Ficat stage III was isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743, P = 0.018).
CONCLUSION


The 10-year follow-up results of this prospective, double-blinded, randomized, controlled study showed that the use of autologous BBC in combination with core decompression was more effective than the use of core decompression alone.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01613612 . Registered on 13 December 2011-retrospectively registered.",2020,"The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029).","['31 patients (41 hips', 'patients with avascular necrosis of the femoral head', 'We recruited 43 (53 hips) patients from 2009 to 2010', 'patients with ANFH']","['autologous BBC', 'code decompression (CD) with or without bone marrow buffy coat (BBC) grafting', 'CD + BBC', 'autologous bone marrow buffy coat grafting combined with core decompression']","['preoperative Ficat stage', 'visual analogue scale (VAS), Lequesne algofunctional index, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores', 'average survival times', 'subjective assessment scores', 'progression to Ficat stage IV or conversion to hip arthroplasty']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0443089', 'cui_str': 'Leukocyte buffy coat'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444669', 'cui_str': 'Core'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}]",31.0,0.241733,"The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029).","[{'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Yuanchen', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Guangtao', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Ruiying', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Zhantao', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Centre for Orthopaedic Translational Research, School of Surgery, The University of Western Australia, M Block, QE2 Medical Centre, Monash Ave., Nedlands, WA, 6009, Australia. Minghao.zheng@uwa.edu.au.'}, {'ForeName': 'Qiujian', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China. zhengqiujian@gdph.org.cn.""}]",Stem cell research & therapy,['10.1186/s13287-020-01810-8']
3000,32678062,Effectiveness of Interventions to Increase Colorectal Cancer Screening Among American Indians and Alaska Natives.,"INTRODUCTION


Screening rates for colorectal cancer are low in many American Indian and Alaska Native (AI/AN) communities. Direct mailing of a fecal immunochemical test (FIT) kit can address patient and structural barriers to screening. Our objective was to determine if such an evidence-based intervention could increase colorectal cancer screening among AI/AN populations.
METHODS


We recruited study participants from 3 tribally operated health care facilities and randomly assigned them to 1 of 3 study groups: 1) usual care, 2) mailing of FIT kits, and 3) mailing of FIT kits plus follow-up outreach by telephone and/or home visit from an American Indian Community Health Representative (CHR).
RESULTS


Among participants who received usual care, 6.4% returned completed FIT kits. Among participants who were mailed FIT kits without outreach, 16.9% returned the kits - a significant increase over usual care (P < .01). Among participants who received mailed FIT kits plus CHR outreach, 18.8% returned kits, which was also a significant increase over usual care (P < .01) but not a significant increase compared with the mailed FIT kit-only group (P = .44). Of 165 participants who returned FIT kits during the study, 39 (23.6%) had a positive result and were referred for colonoscopy of which 23 (59.0%) completed the colonoscopy. Twelve participants who completed a colonoscopy had polyps, and 1 was diagnosed with colorectal cancer.
CONCLUSION


Direct mailing of FIT kits to eligible community members may be a useful, population-based strategy to increase colorectal cancer screening among AI/AN people.",2020,"Among participants who were mailed FIT kits without outreach, 16.9% returned the kits - a significant increase over usual care (P < .01).","['participants who received usual care, 6.4% returned completed FIT kits', 'Twelve participants who completed a colonoscopy had polyps, and 1 was diagnosed with colorectal cancer', 'American Indians and Alaska Natives', '165 participants who returned FIT kits during the study, 39 (23.6%) had a positive result and were referred for colonoscopy of which 23 (59.0%) completed the colonoscopy', 'study participants from 3 tribally operated health care facilities and randomly assigned them to 1 of 3 study groups: 1']","['usual care, 2) mailing of FIT kits, and 3) mailing of FIT kits plus follow-up outreach by telephone and/or home visit from an American Indian Community Health Representative (CHR']",['usual care'],"[{'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0043459', 'cui_str': 'Zellweger syndrome'}]",[],165.0,0.0522286,"Among participants who were mailed FIT kits without outreach, 16.9% returned the kits - a significant increase over usual care (P < .01).","[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Cancer Prevention and Control, Albuquerque, New Mexico.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'English', 'Affiliation': 'Albuquerque Area Indian Health Board, Albuquerque, New Mexico.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Jacobs-Wingo', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Cancer Prevention and Control, Albuquerque, New Mexico.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Tjemsland', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Cancer Prevention and Control, Albuquerque, New Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Espey', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Cancer Prevention and Control, Albuquerque, New Mexico.'}]",Preventing chronic disease,['10.5888/pcd17.200049']
3001,32673128,A comparison of partitioned survival analysis and state transition multi-state modelling approaches using a case study in oncology.,"Aims:  To construct and compare a partitioned-survival analysis (PartSA) and a semi-Markov multi-state model (MSM) to investigate differences in estimated cost effectiveness of a novel cancer treatment from a UK perspective. Materials and Methods:  Data from a cohort of late-stage cancer patients (N > 700) enrolled within a randomised, controlled trial were used to populate both modelling approaches. The statistical software  R  was used to fit parametric survival models to overall survival (OS) and progression-free survival (PFS) data to inform the PartSA (package  'flexsurv' ). The package  'mstate'  was used to estimate the MSM transitions (permitted transitions: (T1)  'progression-free'  to  'dead' , (T2)  'post-progression'  to  'death' , and (T3)  'pre-progression'  to  'post-progression' ). Key costs included were treatment-related (initial, subsequent, and concomitant), adverse events, hospitalizations and monitoring. Utilities were stratified by progression. Outcomes were discounted at 3.5% per annum over a 15-year time horizon. Results:  The PartSA and MSM approaches estimated incremental cost-effectiveness ratios (ICERs) of £342,474 and £411,574, respectively. Scenario analyses exploring alternative parametric forms provided incremental discounted life-year estimates that ranged from +0.15 to +0.33 for the PartSA approach, compared with -0.13 to +0.23 for the MSM approach. This variation was reflected in the range of ICERs. The PartSA produced ICERs between £234,829 and £522,963, whereas MSM results were more variable and included instances where the intervention was dominated and ICERs above £7 million (caused by very small incremental QALYs). Limitations and Conclusions:  Structural uncertainty in economic modelling is rarely explored due to time and resource limitations. This comparison of structural approaches indicates that the choice of structure may have a profound impact on cost-effectiveness results. This highlights the importance of carefully considered model conceptualization, and the need for further research to ascertain when it may be most appropriate to use each approach.",2020,"The PartSA and MSM approaches estimated incremental cost-effectiveness ratios (ICERs) of £342,474 and £411,574, respectively.",['cohort of late-stage cancer patients (N\u2009>\u2009700'],['partitioned-survival analysis (PartSA) and a semi-Markov multi-state model (MSM'],"['adverse events, hospitalizations and monitoring', 'incremental cost-effectiveness ratios (ICERs', 'overall survival (OS) and progression-free survival (PFS) data']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517862', 'cui_str': '700'}]","[{'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.046322,"The PartSA and MSM approaches estimated incremental cost-effectiveness ratios (ICERs) of £342,474 and £411,574, respectively.","[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Cranmer', 'Affiliation': 'Takeda Pharmaceuticals International Co., 61 Aldwych, London, WC2B 4AE, UK.'}, {'ForeName': 'Gemma E', 'Initials': 'GE', 'LastName': 'Shields', 'Affiliation': 'Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Ash', 'Initials': 'A', 'LastName': 'Bullement', 'Affiliation': 'Delta Hat Limited, 212 Tamworth Road, Nottingham, NG10 3GS, UK.'}]",Journal of medical economics,['10.1080/13696998.2020.1796360']
3002,32673160,Adaptations to exercise in compensators and non-compensators in the E-MECHANIC Trial.,"PURPOSE


Rating of Perceived Exertion (RPE) and respiratory exchange ratio (RER) have previously been associated with acute exercise compensation. This study examined adaptations in RPE and RER with long-term exercise training in individuals who did (non-compensators) and did not (compensators) lose the expected amount of weight.
METHODS


Participants (n = 110, 71.8% F, mean ± SD age 49 ± 12 years) completed 24 weeks of supervised exercise training at 65-85% VO 2peak  to achieve a prescribed dose of 8 kcal/kg body weight/week (8 KKW) or 20 KKW. Participants were categorized as non-compensators (n=55) or compensators (n=55) based on the percent of expected weight loss (%EWL) achieved. Changes in RPE and RER during exercise over time (baseline, week 12, week 24) were compared by weight compensation category. Individual %EWL in relation to RPE, RER, and training intensity (%VO 2peak ) was evaluated over the same time period.
RESULTS


RPE and RER for a given workload decreased from baseline to week 12 and stabilized through week 24, regardless of weight compensation (time p<0.0001). Non-compensators had a higher RPE relative to heart rate, which was partly explained by higher %VO 2peak . RPE and %VO 2peak  both positively predicted %EWL, independent of age, sex, and exercise dose.
CONCLUSION


Training intensity and RPE were positively associated with weight loss on the individual level, warranting further investigation into self-selection in exercise-based programs. Understanding individual heterogeneity in training intensity and behavioral responses may improve future weight management efforts that involve exercise.",2020,"Non-compensators had a higher RPE relative to heart rate, which was partly explained by higher %VO 2peak .","['Participants (n = 110, 71.8% F, mean ± SD age 49 ± 12 years) completed 24 weeks of', 'Participants were categorized as non-compensators (n=55) or compensators (n=55) based on the percent of expected weight loss (%EWL) achieved', 'individuals who did (non-compensators) and did not (compensators']","['supervised exercise training at 65-85% VO 2peak  to achieve a prescribed dose of 8 kcal/kg body weight/week (8 KKW) or 20 KKW', 'RER with long-term exercise training', 'Perceived Exertion (RPE) and respiratory exchange ratio (RER']","['weight loss', 'RPE relative to heart rate']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0560602', 'cui_str': 'kcal/kg body weight'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0200206,"Non-compensators had a higher RPE relative to heart rate, which was partly explained by higher %VO 2peak .","[{'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Fearnbach', 'Affiliation': 'Clinical Sciences Division, Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': 'School of Kinesiology, Louisiana State University, United States.'}, {'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Health and Kinesiology, Texas A&M University, United States.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': 'University of North Carolina at Charlotte, United States.'}, {'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Harris', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': 'Pennington Biomedical Research Center, United States.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Ingestive Behavior Laboratory, Pennington Biomedical Research Center, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00826.2019']
3003,32673171,Sorafenib Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia With  FLT3 -Internal Tandem Duplication Mutation (SORMAIN).,"PURPOSE


Despite undergoing allogeneic hematopoietic stem cell transplantation (HCT), patients with acute myeloid leukemia (AML) with internal tandem duplication mutation in the  FMS- like tyrosine kinase 3 gene ( FLT3- ITD) have a poor prognosis, frequently relapse, and die as a result of AML. It is currently unknown whether a maintenance therapy using FLT3 inhibitors, such as the multitargeted tyrosine kinase inhibitor sorafenib, improves outcome after HCT.
PATIENTS AND METHODS


In a randomized, placebo-controlled, double-blind phase II trial (SORMAIN; German Clinical Trials Register: DRKS00000591), 83 adult patients with  FLT3- ITD-positive AML in complete hematologic remission after HCT were randomly assigned to receive for 24 months either the multitargeted and FLT3-kinase inhibitor sorafenib (n = 43) or placebo (n = 40 placebo). Relapse-free survival (RFS) was the primary endpoint of this trial. Relapse was defined as relapse or death, whatever occurred first.
RESULTS


With a median follow-up of 41.8 months, the hazard ratio (HR) for relapse or death in the sorafenib group versus placebo group was 0.39 (95% CI, 0.18 to 0.85; log-rank  P  = .013). The 24-month RFS probability was 53.3% (95% CI, 0.36 to 0.68) with placebo versus 85.0% (95% CI, 0.70 to 0.93) with sorafenib (HR, 0.256; 95% CI, 0.10 to 0.65; log-rank  P  = .002). Exploratory data show that patients with undetectable minimal residual disease (MRD) before HCT and those with detectable MRD after HCT derive the strongest benefit from sorafenib.
CONCLUSION


Sorafenib maintenance therapy reduces the risk of relapse and death after HCT for  FLT3- ITD-positive AML.",2020,", the hazard ratio (HR) for relapse or death in the sorafenib group versus placebo group was 0.39 (95% CI, 0.18 to 0.85; log-rank  P  = .013).","['ITD-positive AML in complete hematologic remission after HCT', '83 adult patients with', 'patients with acute myeloid leukemia (AML) with internal tandem duplication mutation']","['multitargeted and FLT3-kinase inhibitor sorafenib', 'Sorafenib Maintenance', 'FLT3', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'allogeneic hematopoietic stem cell transplantation (HCT', 'Sorafenib maintenance therapy', 'placebo']","['relapse or death', '24-month RFS probability', 'Relapse-free survival (RFS', 'hazard ratio (HR) for relapse or death', 'Relapse', 'risk of relapse and death']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",83.0,0.554634,", the hazard ratio (HR) for relapse or death in the sorafenib group versus placebo group was 0.39 (95% CI, 0.18 to 0.85; log-rank  P  = .013).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Bug', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Lea V', 'Initials': 'LV', 'LastName': 'Fritz', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Finke', 'Affiliation': 'Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Freiburg University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Department of Medicine A/Hematology and Oncology, University of Muenster, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Röllig', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wollmer', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wäsch', 'Affiliation': 'Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Freiburg University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bornhäuser', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Berg', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lang', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zeiser', 'Affiliation': 'Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Freiburg University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': 'Medical Department III, Hematology, Medical Oncology and Pneumology, University Mainz, Germany.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wolschke', 'Affiliation': 'Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schleuning', 'Affiliation': 'German Clinic for Diagnostics, Helios Clinic, Wiesbaden, Germany.'}, {'ForeName': 'Katharina S', 'Initials': 'KS', 'LastName': 'Götze', 'Affiliation': 'Department of Medicine III, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmid', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crysandt', 'Affiliation': 'Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Eßeling', 'Affiliation': 'Department of Medicine A/Hematology and Oncology, University of Muenster, Münster, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Bonn, Bonn, Germany; and Department of Hematology and Oncology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Böhm', 'Affiliation': 'Department of Hematology/Oncology/Stem Cell Transplantation, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Haferlach', 'Affiliation': 'Munich Leukemia Laboratory, Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Michel', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bethge', 'Affiliation': 'University of Tuebingen Medical Center, Tuebingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wündisch', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandts', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Harnisch', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wittenberg', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Heinz-Gert', 'Initials': 'HG', 'LastName': 'Hoeffkes', 'Affiliation': 'Tumorklinik (Medizinische Onkologie, Palliativmedizin, Hämatologie und Hämostasiologie), Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rospleszcz', 'Affiliation': 'Chair of Genetic Epidemiology, Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, Faculty of Medicine, Ludwigs Maximilian Universität München and Institute of Genetic Epidemiology, Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Burchardt', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, University Hospital Gießen and Marburg, Campus Gießen, Gießen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Brugger', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, Faculty of Medicine, Ludwigs Maximilian Universität München and Institute of Genetic Epidemiology, Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, Germany and Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Strauch', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, Faculty of Medicine, Ludwigs Maximilian Universität München and Institute of Genetic Epidemiology, Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, Germany and Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Stephan K', 'Initials': 'SK', 'LastName': 'Metzelder', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03345']
3004,32673213,Barriers and facilitators for referrals of primary care patients to blended internet-based psychotherapy for depression: A mixed methods study of general practitioners' views.,"BACKGROUND


Major Depressive Disorder (MDD) is highly prevalent and often managed by general practitioners (GPs). GPs mostly prescribe medication and show low referral rates to psychotherapy. Many patients remain untreated. Blended Psychotherapy (bPT) combines internet-based interventions with face-to-face psychotherapy and could increase treatment access and availability. Effectively implementing bPT in routine care requires an understanding of professional users' perspectives and behavior.
OBJECTIVE


The study aimed to identify barriers and facilitators perceived by GPs in referring patients to bPT. Explanations for variations in referral rates were examined.
METHODS


Qualitative approach: Semi-structured interviews with 12 of 110 GPs participating in a German randomized-controlled trial (E-COMPARED) were conducted to investigate barriers and facilitators for referrals to bPT for MDD (10 online-modules, app-based assessments and 6 face-to-face sessions). The interview guide was based on the Theoretical Domains Framework. The interviews were audio-recorded, transcribed verbatim, and qualitative content analyzed by two independent coders (intercoder agreement, k=.71). Quantitative approach: A follow-up survey with the 12 GPs enabled the validation of emergent themes. Differences in the barriers and facilitators identified between groups with different characteristics (GPs with high/low referral rates or experience or training in psychotherapy) were described. Correlations between referrals and characteristics, self-rated competences, and experiences managing depression of the RCT-GPs (N=76) were conducted.
RESULTS


GPs referred few patients to bPT, although varied in their referral rates, and interviewees referred more than twice as many patients as GPs in the RCT (Interview-GPs: M=6.34, SD=9.42; RCT-GPs: M=2.65, SD=3.93). A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-.31, P<.01. The qualitative findings revealed a total of 19 barriers (B) and 29 facilitators (F), at the levels of GP (B=4, F=11), patient (B=11, F=9), GP practice (B=1, F=3) and socio-political circumstances (B=3, F=6). Key barriers stated by all interviewed GPs included 'little knowledge about internet-based interventions' and 'patients' lack of familiarity with technology/internet/media' (number of statements, each k=22). Key facilitators were 'perceived patient suitability, e.g. well-educated, young' (k=22) and 'no conflict with GP's role' (k=16). The follow-up survey with the interviewed GPs showed a very high agreement rate of at least 75% for 71% (34/48) of the identified themes. Descriptive findings indicated differences between GPs with low and high referral rates in terms of which and how many barriers (low: M=9.75, SD=1.83; high: M=10.50, SD=2.38) and facilitators (low: M=18.25, SD=4.13; high: M=21.00; SD=3.92) they mentioned.
CONCLUSIONS


This study provides insights into factors influencing GPs' referrals to bPT as gatekeepers to depression care. The identified barriers and facilitators should be considered when designing implementation strategies to enhance GPs' referral rates. Overall, GPs appeared to be ready to integrate bPT in their depression management. Findings should be interpreted with care due to the small and self-selected sample and low response rates.",2020,"A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-.31, P<.01.",['Qualitative approach: Semi-structured interviews with 12 of 110 GPs participating in a German randomized-controlled trial (E-COMPARED'],"['blended internet-based psychotherapy', 'Blended Psychotherapy (bPT', 'Quantitative approach']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],76.0,0.0501087,"A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-.31, P<.01.","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Nägelsbachstraße 25a, Erlangen, DE.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Nägelsbachstraße 25a, Erlangen, DE.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlicker', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Nägelsbachstraße 25a, Erlangen, DE.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Faculty of Behavioral and Movement Sciences, Section of Clinical Psychology, VU University Amsterdam, Amsterdam, NL.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Nägelsbachstraße 25a, Erlangen, DE.'}]",JMIR mental health,['10.2196/18642']
3005,32678131,Clinical efficacy of eyelid hygiene in blepharitis and meibomian gland dysfunction after cataract surgery: a randomized controlled pilot trial.,"The purpose of this randomized clinical trial is to evaluate the effect of eyelid hygiene on subjective symptoms, anterior blepharitis, and meibomian gland dysfunction (MGD) after cataract surgery. Subjects with obstructive MGD who underwent cataract surgery were randomly divided into two groups. In the eyelid hygiene group, eyelid hygiene was performed twice a day for 10 days from 3 days before to 1 week after cataract surgery. The control group did not perform eyelid hygiene. A subjective symptom questionnaire of SPEED, anterior blepharitis grade, and meibum quality and quantity was evaluated at baseline and at postoperative 1 and 4 weeks. The eyelid hygiene group (n = 36) showed decreased SPEED score after cataract surgery and the control group (n = 33) did not. Anterior blepharitis grade was worse 1 week after surgery in the control group but not in the eyelid hygiene group. The control group had significantly decreased meibum quality and quantity in both the upper and lower eyelids after cataract surgery, but the eyelid hygiene group did not. Eyelid hygiene before/after cataract surgery improved postoperative subjective symptoms and prevented postoperative exacerbation of anterior blepharitis and MGD. Thus, perioperative eyelid hygiene is recommended for patients with obstructive MGD who undergo cataract surgery.",2020,"The control group had significantly decreased meibum quality and quantity in both the upper and lower eyelids after cataract surgery, but the eyelid hygiene group did not.","['Subjects with obstructive MGD who underwent cataract surgery', 'patients with obstructive MGD who undergo cataract surgery', 'cataract surgery', 'blepharitis and meibomian gland dysfunction after cataract surgery']",['eyelid hygiene'],"['Anterior blepharitis grade', 'subjective symptoms, anterior blepharitis, and meibomian gland dysfunction (MGD', 'meibum quality and quantity in both the upper and lower eyelids', 'postoperative subjective symptoms', 'subjective symptom questionnaire of SPEED, anterior blepharitis grade, and meibum quality and quantity', 'postoperative exacerbation of anterior blepharitis and MGD', 'eyelid hygiene', 'Eyelid hygiene', 'SPEED score']","[{'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C5197842', 'cui_str': 'Meibomian Lipids'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0203607,"The control group had significantly decreased meibum quality and quantity in both the upper and lower eyelids after cataract surgery, but the eyelid hygiene group did not.","[{'ForeName': 'Youngsub', 'Initials': 'Y', 'LastName': 'Eom', 'Affiliation': 'Department of Ophthalmology, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, South Korea.'}, {'ForeName': 'Kyung Sun', 'Initials': 'KS', 'LastName': 'Na', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Ho Sik', 'Initials': 'HS', 'LastName': 'Hwang', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Kyong Jin', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': 'Department of Ophthalmology, Dankook University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Roo Min', 'Initials': 'RM', 'LastName': 'Jun', 'Affiliation': ""Department of Ophthalmology, Ewha Woman's University School of Medicine, Seoul, South Korea.""}, {'ForeName': 'Byung Yi', 'Initials': 'BY', 'LastName': 'Ko', 'Affiliation': 'Department of Ophthalmology, Konyang University College of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Yeoun Sook', 'Initials': 'YS', 'LastName': 'Chun', 'Affiliation': 'Department of Ophthalmology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ""Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Jong Suk', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea. crisim@korea.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-67888-5']
3006,32678132,"Resistance training improves sleep quality, redox balance and inflammatory profile in maintenance hemodialysis patients: a randomized controlled trial.","Patients in maintenance hemodialisys (HD) present sleep disorders, increased inflammation, unbalanced redox profiles, and elevated biomarkers representing endothelial dysfunction. Resistance training (RT) has shown to mitigate the loss of muscle mass, strength, improve inflammatory profiles, and endothelial function while decreasing oxidative stress for those in HD. However, the relation between those factors and sleep quality are inadequately described. The aim of this study was to verify the effects of 3 months of RT on sleep quality, redox balance, nitric oxide (NO) bioavailability, inflammation profile, and asymmetric dimethylarginine (ADMA) in patients undergoing HD. Our primary goal was to describe the role of RT on sleep quality. Our secondary goal was to evaluate the effect of RT on NO, metabolism markers, and inflammatory and redox profiles as potential mechanisms to explain RT-induced sleep quality changes. Fifty-five men undergoing maintenance hemodialysis were randomized into either a control (CTL, n = 25) and RT group (RTG; n = 30). Participants in the RT group demonstrated an improvement in sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA). This group also increased muscle strength (total workload in RT exercises of upper and lower limbs). These findings support that RT may improve the clinical status of HD patients by improving their sleep quality, oxidative and inflammatory parameters.",2020,"Participants in the RT group demonstrated an improvement in sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA).","['Fifty-five men undergoing maintenance hemodialysis', 'patients undergoing HD', 'maintenance hemodialysis patients']","['control (CTL, n\u2009=\u200925) and RT', 'Resistance training', 'Resistance training (RT']","['sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA', 'sleep quality, redox balance, nitric oxide (NO) bioavailability, inflammation profile, and asymmetric dimethylarginine (ADMA', 'muscle strength (total workload in RT exercises of upper and lower limbs', 'sleep quality, redox balance and inflammatory profile', 'sleep quality', 'sleep quality, oxidative and inflammatory parameters']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",55.0,0.0171028,"Participants in the RT group demonstrated an improvement in sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA).","[{'ForeName': 'Hugo Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil. hugo.efucb@gmail.com.'}, {'ForeName': 'Sting Ray Gouveia', 'Initials': 'SRG', 'LastName': 'Moura', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Tzanno-Martins', 'Affiliation': 'HDC RenalClass, São Paulo, SP, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anderson Sola', 'Initials': 'AS', 'LastName': 'Haro', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Adeirton Bezerra', 'Initials': 'JAB', 'LastName': 'Silva', 'Affiliation': 'HDC RenalClass, São Paulo, SP, Brazil.'}, {'ForeName': 'Whitley', 'Initials': 'W', 'LastName': 'Stone', 'Affiliation': 'School of Kinesiology, Recreation, and Sport, Western Kentucky University, Bowling Green, KY, USA.'}, {'ForeName': 'Fernando Sousa', 'Initials': 'FS', 'LastName': 'Honorato', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Elaine Cristina', 'Initials': 'EC', 'LastName': 'Vieira', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Gislane Ferreira', 'Initials': 'GF', 'LastName': 'de Melo', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}]",Scientific reports,['10.1038/s41598-020-68602-1']
3007,32678200,Individual versus team heart rate variability responsiveness analyses in a national soccer team during training camps.,"Heart rate variability (HRV) analyses can be performed using group or individual changes. Individual changes could be of potential interest during training camps for national soccer teams. The purpose of this study was to compare whether analysis of individual daily HRV could detect changes in cardiac autonomic responses during training camps for national soccer teams. During two different training camps, 34 professional soccer players were monitored daily over 9 days, using heart rate monitors. Players were divided into First Eleven (those who participated in the main squad) or Reserves. Daily HRV was individually analyzed using a day-to-day method or a baseline (days prior to first match) method, using the smallest worthwhile change and the typical error in the estimate to establish a trivial (random change) zone. Group changes were also analyzed using an ANOVA one-way repeated measures test. Players' responsiveness was classified as High-, Low- or Non-response depending on individual changes. Both analyses showed substantial daily individual changes after playing a soccer match, regardless of the group. However, group changes showed that only First Eleven players had significant changes after playing a soccer match. In conclusion, individual daily HRV analyses are useful in detecting individual changes in professional soccer players.",2020,"Both analyses showed substantial daily individual changes after playing a soccer match, regardless of the group.","['Players were divided into First Eleven (those who participated in the main squad) or Reserves', 'national soccer teams', 'professional soccer players', '34 professional soccer players']",[],"['Daily HRV', 'Heart rate variability (HRV) analyses', 'cardiac autonomic responses']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",34.0,0.0198656,"Both analyses showed substantial daily individual changes after playing a soccer match, regardless of the group.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Muñoz-López', 'Affiliation': 'Departamento de Motricidad Humana y Rendimiento Deportivo, Education Sciences School, University of Seville, Desk 4.78, c/Pirotecnica s/n, 41013, Seville, Spain. amunlop@gmail.com.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Naranjo-Orellana', 'Affiliation': 'Sports and Computers Department, University Pablo de Olavide, Seville, Spain.'}]",Scientific reports,['10.1038/s41598-020-68698-5']
3008,32678285,Cerebellar transcranial direct current stimulation for learning a novel split-belt treadmill task: a randomised controlled trial.,"This study aimed to examine the effect of repeated anodal cerebellar transcranial direct current stimulation (ctDCS) on learning a split-belt treadmill task. Thirty healthy individuals randomly received three consecutive sessions of active or sham anodal ctDCS during split-belt treadmill training. Motor performance and strides to steady-state performance were evaluated before (baseline), during (adaptation), and after (de-adaptation) the intervention. The outcomes were measured one week later to assess absolute learning and during the intervention to evaluate cumulative, consecutive, and session-specific effects. Data were analysed using linear mixed-effects regression models. During adaptation, there was no significant difference in absolute learning between the groups (p > 0.05). During de-adaptation, a significant difference in absolute learning between the groups (p = 0.03) indicated slower de-adaptation with anodal ctDCS. Pre-planned secondary analysis revealed that anodal ctDCS significantly reduced the cumulative (p = 0.01) and consecutive-session effect (p = 0.01) on immediate adaptation. There were significant cumulative (p = 0.02) and session-specific effects (p = 0.003) on immediate de-adaptation. Repeated anodal ctDCS does not enhance motor learning measured during adaptation to a split-belt treadmill task. However, it influences the maintenance of learnt walking patterns, suggesting that it may be beneficial in maintaining therapeutic effects.",2020,There were significant cumulative (p = 0.02) and session-specific effects (p = 0.003) on immediate de-adaptation.,['Thirty healthy individuals'],"['active or sham anodal ctDCS during split-belt treadmill training', 'anodal cerebellar transcranial direct current stimulation (ctDCS', 'Cerebellar transcranial direct current stimulation', 'anodal ctDCS']","['Motor performance and strides to steady-state performance', 'motor learning', 'absolute learning', 'session-specific effects']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",30.0,0.0490166,There were significant cumulative (p = 0.02) and session-specific effects (p = 0.003) on immediate de-adaptation.,"[{'ForeName': 'Nitika', 'Initials': 'N', 'LastName': 'Kumari', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand. nitika.kumari@aut.ac.nz.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Rashid', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Biomedical Sciences, Brain Health Research Centre, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Signal', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}]",Scientific reports,['10.1038/s41598-020-68825-2']
3009,32678299,The influence of foot and back massage on blood pressure and sleep quality in females with essential hypertension: a randomized controlled study.,"The present study was conducted with the aim of investigating the influence of foot and back massage on blood pressure and sleep quality in females with essential hypertension. Non-pharmacologic methods like massage may be effective for balancing blood pressure and solving sleep problems. This is a randomized controlled study conducted in accordance with CONSORT rules. Females with essential hypertension were applied a total of six sessions of 30 min of foot and back massage twice weekly during 3 weeks. The study included a total of 90 patients of whom 60 were in intervention group (foot massage group, back massage group) and 30 in control group. Data were collected through personal data form (PDF) which included descriptive characteristics, Pittsburgh Sleep Quality Index (PSQI). Six sessions of foot massage and back massage were detected to lead to a reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values and the difference was statistically significant (p < 0.001). A strong statistical difference was found between mean pretest posttest scores of overall and sub-dimensional scores of PSQI in females in intervention group (p < 0.001). Foot and back massage was found to be effective in reducing blood pressure and improving sleep quality.",2020,A strong statistical difference was found between mean pretest posttest scores of overall and sub-dimensional scores of PSQI in females in intervention group (p < 0.001).,"['Females with essential hypertension', '90 patients of whom 60 were in', 'females with essential hypertension']","['foot and back massage', 'intervention group (foot massage group, back massage group) and 30 in control group']","['blood pressure and sleep quality', 'blood pressure and improving sleep quality', 'systolic blood pressure (SBP) and diastolic blood pressure (DBP) values', 'Pittsburgh Sleep Quality Index (PSQI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",90.0,0.0242063,A strong statistical difference was found between mean pretest posttest scores of overall and sub-dimensional scores of PSQI in females in intervention group (p < 0.001).,"[{'ForeName': 'Gürcan', 'Initials': 'G', 'LastName': 'Arslan', 'Affiliation': 'Department of Internal Diseases Nursing, Faculty of Health Sciences, Sivas Cumhuriyet University, Sivas, Turkey. gurcansolmaz@hotmail.com.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Ceyhan', 'Affiliation': 'Department of Internal Diseases Nursing, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Mukadder', 'Initials': 'M', 'LastName': 'Mollaoğlu', 'Affiliation': 'Department of Internal Diseases Nursing, Faculty of Health Sciences, Sivas Cumhuriyet University, Sivas, Turkey.'}]",Journal of human hypertension,['10.1038/s41371-020-0371-z']
3010,32678376,Weighted Blankets: Anxiety Reduction in Adult Patients Receiving Chemotherapy.,"BACKGROUND


Weighted blankets have been used as a deep touch pressure (DTP) tool to alleviate anxiety in many patient populations. Patients with cancer can experience anxiety related to diagnosis and treatments, such as chemotherapy infusions. Research on the effectiveness of weighted blankets as a DTP tool to alleviate anxiety in patients receiving chemotherapy is limited.
OBJECTIVES


This study assessed the effectiveness of a medical-grade therapeutic weighted blanket on anxiety in patients receiving their first and second chemotherapy infusions at an outpatient infusion center.
METHODS


A randomized controlled trial with a crossover design was performed with new patients in the outpatient chemotherapy infusion center. Patients were randomized to one of two study arms (given the weighted blanket during their first infusion or given the weighted blanket during their second infusion). Anxiety was measured using an anxiety inventory and a visual analog scale.
FINDINGS


Anxiety was reduced among patients receiving chemotherapy when the weighted blanket was used. Based on the results, a standard-weight, medical-grade therapeutic weighted blanket can be safely used to reduce anxiety in patients of various weights, and a visual analog scale can be a reliable indicator of patients' state anxiety.
",2020,"This study assessed the effectiveness of a medical-grade therapeutic weighted blanket on anxiety in patients receiving their first and second chemotherapy infusions at an outpatient infusion center.
","['new patients in the outpatient chemotherapy infusion center', 'patients receiving chemotherapy is limited', 'patients receiving their first and second chemotherapy infusions at an outpatient infusion center', 'Patients with cancer', 'Adult Patients Receiving Chemotherapy']","['medical-grade therapeutic weighted blanket', 'weighted blankets']","['Anxiety', 'anxiety inventory and a visual analog scale']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0336687,"This study assessed the effectiveness of a medical-grade therapeutic weighted blanket on anxiety in patients receiving their first and second chemotherapy infusions at an outpatient infusion center.
","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Vinson', 'Affiliation': 'Parkview Health System.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Parkview Health System.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mosesso', 'Affiliation': 'Indiana University.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.360-368']
3011,32678377,Low-Dose Computed Tomography: Effects of Oncology Nurse Navigation on Lung Cancer Screening.,"BACKGROUND


Low-dose computed tomography (LDCT) lung cancer screening is an evidence-based and reimbursable strategy to decrease lung cancer and all-cause mortality in qualifying patients, but there remains low use and variation in providers' LDCT screening, ordering, and referring knowledge.
OBJECTIVES


The purpose of this quality improvement project was to examine the effects of oncology nurse navigation on assisting patients and ensuring optimal LDCT lung cancer screening.
METHODS


Oncology nurse navigators conducted LDCT provider education and navigated 133 eligible patients to LDCT during a five-month intervention time period.
FINDINGS


Provider education resulted in improved documented tobacco cessation discussions and increased LDCT screening ordering fidelity. Mean days from LDCT to provider notification and mean days from LDCT to patient notification improved significantly.
",2020,"Mean days from LDCT to provider notification and mean days from LDCT to patient notification improved significantly.
","['Oncology nurse navigators conducted LDCT provider education and navigated 133 eligible patients to LDCT during a five-month intervention time period', 'Lung Cancer Screening']","['oncology nurse navigation', 'Low-dose computed tomography (LDCT) lung cancer screening', 'Oncology Nurse Navigation', 'Low-Dose Computed Tomography']",['tobacco cessation discussions'],"[{'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}]","[{'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}]","[{'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",133.0,0.0540633,"Mean days from LDCT to provider notification and mean days from LDCT to patient notification improved significantly.
","[{'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Baylor Scott and White Medical Center.'}, {'ForeName': 'Marion E', 'Initials': 'ME', 'LastName': 'Broome', 'Affiliation': 'Duke University.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Schneider', 'Affiliation': 'Duke University.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.421-429']
3012,32678434,The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants.,"BACKGROUND


In adults, oral iron doses increase plasma hepcidin (PHep) for 24 h, but not for 48 h, and there is a circadian increase in PHep over the day. Because high PHep decreases fractional iron absorption (FIA), alternate day iron dosing in the morning may be preferable to consecutive day dosing. Whether these effects occur in infants is uncertain.
OBJECTIVE


Using stable iron isotopes in Kenyan infants, we compared FIA from morning and afternoon doses and from consecutive, alternate (every second day) and every third day iron doses.
METHODS


In prospective studies, we measured and compared FIA and the PHep response from 1) meals fortified with a 12-mg iron micronutrient powder given in the morning or afternoon (n = 22); 2) the same given on consecutive or alternate days (n = 21); and 3) a 12-mg iron supplement given on alternate days or every third day (n = 24).
RESULTS


In total, 65.7% of infants were anemic. In study 1, PHep did not differ between morning and afternoon (P = 0.072), and geometric mean FIA[-SD, +SD](%) did not differ between the morning and afternoon doses [15.9 (8.9, 28.6) and 16.1 (8.7, 29.8), P = 0.877]. In study 2, PHep was increased 24 h after oral iron (P = 0.014), and mean FIA [±SD](%) from the baseline dose [23.3 (10.9)] was greater than that from the consecutive day dose (at 24 h) [20.1 (10.4); P = 0.042] but did not differ from the alternate day dose (at 48 h) [20.9 (13.4); P = 0.145]. In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
CONCLUSIONS


In Kenyan infants given 12 mg oral iron, morning and afternoon doses are comparably absorbed, dosing on consecutive days increases PHep and modestly decreases iron absorption compared with alternate day dosing, and dosing on alternate days or every third day does not increase PHep or decrease absorption. This trial was registered at clinicaltrials.gov as NCT02989311 and NCT03617575.",2020,"In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
",['Kenyan infants'],[],"['geometric mean FIA[-SD, +SD', 'iron absorption', 'mean FIA [±SD', 'PHep or decrease absorption', 'plasma hepcidin and iron absorption', 'fractional iron absorption (FIA']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",,0.224107,"In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Uyoga', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Mikulic', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Paganini', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Mwasi', 'Affiliation': 'Pediatric Department, Msambweni County Referral Hospital, Msambweni, Kenya.'}, {'ForeName': 'Nicole U', 'Initials': 'NU', 'LastName': 'Stoffel', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zeder', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Karanja', 'Affiliation': 'Public and Community Health Department, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa174']
3013,32673591,Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity.,"Time-restricted feeding (TRF) regimens have grown in popularity; however, very few studies have examined their weight-loss efficacy. We conducted the first human trial (Clinicaltrials.gov NCT03867773) to compare the effects of two popular forms of TRF (4 and 6 h) on body weight and cardiometabolic risk factors. Adults with obesity were randomized to 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions). After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls. Energy intake was reduced by ∼550 kcal/day in both TRF groups, without calorie counting. These findings suggest that 4- and 6-h TRF induce mild reductions in body weight over 8 weeks and show promise as interventions for weight loss. These diets may also improve some aspects of cardiometabolic health.",2020,"After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls.","['Adults with Obesity', 'Adults with obesity']","['4-h TRF', 'TRF', '4- and 6-h Time-Restricted Feeding', 'control group (no meal timing restrictions']","['body weight (∼3%), insulin resistance, and oxidative stress', 'body weight', 'Energy intake', 'Weight and Cardiometabolic Health', 'body weight and cardiometabolic risk factors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.0381324,"After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Cienfuegos', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Gabel', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Kalam', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ezpeleta', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wiseman', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Pavlou', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Shuhao', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Manoela Lima', 'Initials': 'ML', 'LastName': 'Oliveira', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Krista A', 'Initials': 'KA', 'LastName': 'Varady', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: varady@uic.edu.'}]",Cell metabolism,['10.1016/j.cmet.2020.06.018']
3014,32673652,Can the positional release technique affect central sensitization in patients with chronic tension-type headache? A randomized clinical trial.,"OBJECTIVE


To investigate whether the positional release technique (PRT) affects central sensitization in patients with chronic TTH.
DESIGN


Randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis.
SETTING


Two university neurology clinics.
PARTICIPANTS


32 patients with TTH and MTrPs in their cervical muscles.
INTERVENTION


Patients in the PRT group received 10 treatment sessions for each of their MTrPs during 5 weeks. All participants were allowed to use ibuprofen 200 mg for their headaches during the study.
MAIN OUTCOME MEASURES


The primary outcome measure was brain metabolite profile and secondary outcome measures were headache frequency and intensity, McGill score, and pressure pain threshold, which were evaluated in each participant during 5 weeks with proton magnetic resonance spectroscopy, patients' self-reports, the McGill Pain Questionnaire and a pressure algometer.
RESULTS


Analysis of the data from 26 patients showed that headache frequency (p=0.001), headache intensity (p=0.002), McGill score (p=0.003), and local PPT (p=0.003) changed significantly after PRT. Myo-inositol/creatine concentration ratio in the somatosensory cortex (p=0.041) decreased significantly in the control group. Furthermore, there were significant differences between groups in headache frequency (p<0.001), headache intensity (p<0.001), McGill score (p<0.001), local PPT (p=0.004), distal PPT (p=0.041), and glutamate-glutamine/creatine concentration ratio in the thalamus (p=0.014).
CONCLUSION


These findings indicate that despite the improvement in clinical symptoms, PRT did not affect central sensitization in patients with TTH.",2020,Myo-inositol/creatine concentration ratio in the somatosensory cortex (p=0.041) decreased significantly in the control group.,"['patients with chronic TTH', 'patients with TTH', '32 patients with TTH and MTrPs in their cervical muscles', 'patients with chronic tension-type headache', 'Two university neurology clinics']","['positional release technique (PRT', 'ibuprofen']","['McGill Pain Questionnaire and a pressure algometer', 'headache frequency', 'distal PPT', 'brain metabolite profile', 'McGill score', 'local PPT', 'headache frequency and intensity, McGill score, and pressure pain threshold', 'headache intensity', 'Myo-inositol/creatine concentration ratio', 'headache intensity (p<0.001), McGill score (p<0.001), local PPT', 'glutamate-glutamine/creatine concentration ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0393738', 'cui_str': 'Chronic tension-type headache'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]",32.0,0.145641,Myo-inositol/creatine concentration ratio in the somatosensory cortex (p=0.041) decreased significantly in the control group.,"[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mohamadi', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rojhani-Shirazi', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: rojhaniz@sums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Assadsangabi', 'Affiliation': 'Department of Radiology, Davis School of Medicine, University of California, USA.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Rahimi-Jaberi', 'Affiliation': 'Department of Neurology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.028']
3015,32673766,Making sense of cross-trial comparisons for the frontline treatment of advanced-stage Hodgkin lymphoma.,,2020,,['advanced-stage Hodgkin lymphoma'],[],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}]",[],[],,0.0468669,,"[{'ForeName': 'Deepesh P', 'Initials': 'DP', 'LastName': 'Lad', 'Affiliation': 'Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: deepesh.lad12@gmail.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.012']
3016,32673830,Accelerated treatment of endocarditis-The POET II trial: Rationale and design of a randomized controlled trial.,"BACKGROUND


The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients.
OBJECTIVE


The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE.
METHODS


The POET II trial is a multicenter, multinational, open-label, noninferiority randomized controlled trial. Patients with definite left-sided IE due to Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis will be eligible for enrolment. Each patient will be randomized to accelerated antibiotic treatment or standard-length treatment (1:1) following clinical stabilization as defined by clinical parameters, laboratory values, and transesophageal echocardiography findings. Accelerated treatment will be between 2 and 4 weeks, whereas standard-length treatment will be between 4 and 6 weeks, depending on microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis. The primary outcome is a composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6 months of randomization.
CONCLUSIONS


The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis. The results of the POET II trial will improve the evidence base of treatment recommendations, and clinical practice may be altered.",2020,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","['patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis', 'patients with left-sided IE']","['accelerated (shortened) antibiotic therapy', 'accelerated antibiotic therapy']","['microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis', 'composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6\u202fmonths of randomization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1827151', 'cui_str': 'Left sided infective endocarditis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1142550', 'cui_str': 'Native valve endocarditis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.224308,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","[{'ForeName': 'Lauge', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mia Marie', 'Initials': 'MM', 'LastName': 'Pries-Heje', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus Bo', 'Initials': 'RB', 'LastName': 'Hasselbalch', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Åkesson', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horvath', 'Affiliation': 'Department of Infectious Diseases, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Povlsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Müllertz', 'Affiliation': 'Department of Cardiology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Christian Ditlev', 'Initials': 'CD', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Ihlemann', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jannik', 'Initials': 'J', 'LastName': 'Helweg-Larsen', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Microbiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emil Loldrup', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark. Electronic address: Henning.Bundgaard@regionh.dk.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.05.012']
3017,32673877,Patient Advocates for low-income adults with moderate-severe asthma: a randomized clinical trial.,"BACKGROUND


Few interventions have targeted low-income adults with moderate-severe asthma despite their high mortality.
OBJECTIVE


To assess whether a Patient Advocate intervention improves asthma outcomes over usual care.
METHODS


This 2-armed randomized clinical trial recruited adults with moderate-severe asthma from primary care and asthma specialty practices serving low-income neighborhoods. Patients were randomized to 6 months of a Patient Advocate Intervention or usual care. Patient Advocates were recent college graduates anticipating healthcare careers, who coached, modeled, and assisted participants with preparations for asthma-related medical visits; attended visits; and confirmed participants' understanding of provider recommendations.
PARTICIPANTS


were followed for at least a year for patient-centered asthma outcomes: asthma control (primary outcome), quality of life, prednisone requirements, emergency department visits, hospitalizations.
RESULTS


Of 312 participants, mean age: 51(range:19-93), 69% female, 66% African American, 8% Hispanic/Latino; 62% reported hospitalization for asthma in the year before randomization. 21% had diabetes, 61% BMI > 30. Asthma control improved over 12 months, more in the intervention group [-0.45(-0.67, -0.21)] than in usual care [-0.26(-0.53, -0.01)], was sustained at 24 months but with no statistical difference between groups. The 6-month rate of ED visits decreased in intervention: -0.90(-1.56, -0.42) and usual care over 12 months: -0.42(-0.72, -0.06) groups. The cost of the Patient Advocate program was $1,521 per patient. Only 64% of those assigned had a Patient Advocate visit.
CONCLUSIONS


A Patient Advocate may be a promising intervention to improve and sustain outcomes in this high-risk population if expanded to address factors that make keeping appointments difficult.",2020,"Asthma control improved over 12 months, more in the intervention group [-0.45(-0.67, -0.21)] than in usual care [-0.26(-0.53, -0.01)], was sustained at 24 months but with no statistical difference between groups.","['51(range:19-93), 69% female, 66% African American, 8% Hispanic/Latino', '312 participants', 'Patient Advocates for low-income adults with moderate-severe asthma', 'adults with moderate-severe asthma from primary care and asthma specialty practices serving low-income neighborhoods', ' mean age']","['Patient Advocate intervention', 'Patient Advocate Intervention or usual care']","['Asthma control', 'quality of life, prednisone requirements, emergency department visits, hospitalizations', '6-month rate of ED visits', 'hospitalization for asthma']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C1998038', 'cui_str': 'Patient advocate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1998038', 'cui_str': 'Patient advocate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.142415,"Asthma control improved over 12 months, more in the intervention group [-0.45(-0.67, -0.21)] than in usual care [-0.26(-0.53, -0.01)], was sustained at 24 months but with no statistical difference between groups.","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: andrea.apter@uphs.upenn.edu.'}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ndicu', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Localio', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Hami', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Mullen', 'Affiliation': 'Temple Physicians, Inc., Temple University Health System, Philadelphia, PA 19129, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Klusaritz', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Zuleyha', 'Initials': 'Z', 'LastName': 'Cidav', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA 19104 USA.'}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.""}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Bender', 'Affiliation': 'National Jewish Health, Denver, CO 80206, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Reisine', 'Affiliation': 'University of Connecticut Health Center, Farmington, CT 06030, USA.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.058']
3018,32673939,Individualized PEEP ventilation between tumor resection and dural suture in craniotomy.,"OBJECTIVE


Atelectasis, which affects oxygenation, is always occurred after craniotomy under general anesthesia. The commonly used protective ventilation strategy, which includes recruitment maneuver and higher level of positive end-expiratory pressure (PEEP), can effectively reduce atelectasis after heart and abdominal surgery, but increase intracranial pressure and reduce cerebral perfusion in patients undergoing craniotomy. We hypothesized individualized PEEP ventilation between tumor resection and dural suture in craniotomy could effectively reduce postoperative atelectasis, improve PaO 2 /FiO 2  ratio, and without reducing the regional cerebral oxygen saturation (rScO 2 ).
PATIENTS AND METHODS


96 patients underwent tumor craniotomy in supine position were randomized into the control group (C group) and individualized PEEP group (P group). In the C group, the tidal volume (VT) was set at 8 mL/kg of predicted body weight, but PEEP were not used. In the P group, VT was set at 6 mL/kg of predicted body weight combined with individualized PEEP between tumor resection and dural suture, while in other periods of general anesthesia, VT was set at 8 mL/kg of predicted body weight. PaO 2 /FiO 2  ratio, lung ultrasound score (LUS) and rScO 2  were measured before induction, 1 h and 24 h after extubation.
RESULTS


Individual PEEP in the P group was 7.0 (4.0-9.0). The PaO 2 /FiO 2  ratio and rScO 2  in the P group were significantly higher than that of the C group (395 ± 62 vs. 344 ± 40, 67 ± 5 vs. 61 ± 4, respectively, p < 0.05) and the LUS of the experimental group was significantly lower than that of the C group [7.5 (5.3-8.3) vs. 10.0 (9.0-12.0), p < 0.05] 1 h after extubation.
CONCLUSION


Mechanical ventilation with individualized PEEP between tumor resection and dural suture in craniotomy can reduce atelectasis, improve PaO 2 /FiO 2  ratio and rScO 2  1 h after extubation.",2020,"The PaO 2 /FiO 2  ratio and rScO 2  in the P group were significantly higher than that of the C group (395 ± 62 vs. 344 ± 40, 67 ± 5 vs. 61 ± 4, respectively, p < 0.05) and the LUS of the experimental group was significantly lower than that of the C group [7.5 (5.3-8.3) vs. 10.0 (9.0-12.0), p < 0.05] 1 h after extubation.
","['patients undergoing craniotomy', '96 patients underwent tumor craniotomy in supine position']","['control group (C group) and individualized PEEP', 'Individualized PEEP ventilation']","['PaO 2 /FiO 2  ratio, lung ultrasound score (LUS) and rScO 2', 'tidal volume (VT', 'LUS', 'regional cerebral oxygen saturation (rScO 2 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}]",96.0,0.0496743,"The PaO 2 /FiO 2  ratio and rScO 2  in the P group were significantly higher than that of the C group (395 ± 62 vs. 344 ± 40, 67 ± 5 vs. 61 ± 4, respectively, p < 0.05) and the LUS of the experimental group was significantly lower than that of the C group [7.5 (5.3-8.3) vs. 10.0 (9.0-12.0), p < 0.05] 1 h after extubation.
","[{'ForeName': 'Hairui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Jinlu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Yueqin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Mingxia', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection Control, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Peimin', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China. Electronic address: xiehong_sz@hotmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Neurosurgery, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China. Electronic address: dongjun@suda.edu.cn.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106027']
3019,32673969,A systematic review and indirect treatment comparison of perampanel versus brivaracetam as adjunctive therapy in patients with focal-onset seizures with or without secondary generalization.,"PURPOSE


To date, there has not been a single randomized controlled trial (RCT) conducted to directly compare the efficacy and safety of perampanel to brivaracetam in the adjunctive treatment of focal-onset seizures. This study makes these comparisons through the use of indirect treatment comparison (ITC) methods.
METHODS


A systematic review was conducted to identify RCTs that evaluated either one of perampanel or brivaracetam in the treatment of patients with focal-onset seizures. The Bucher ITC method was then used to compare efficacy and safety outcomes between perampanel and brivaracetam. Additional subgroup analyses, by levetiracetam usage (prior or concomitant), were conducted.
RESULTS


Eight RCTs (four comparing perampanel to placebo, four comparing brivaracetam to placebo) were included in the ITC. For patients taking concomitant levetiracetam, perampanel showed a significantly better responder rate compared to brivaracetam [relative risk (RR) and 95 % confidence interval (CI): 2.62 (1.15, 5.99)]. For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate. In the overall population, both perampanel and brivaracetam were more effective than placebo in terms of responder rate, seizure freedom, and secondarily generalized tonic-clonic seizure responder rate; however, for these outcomes, no evidence of a difference between perampanel and brivaracetam was found. Patients taking brivaracetam showed significantly less dizziness compared to patients taking perampanel. No differences for any other safety outcome were found.
CONCLUSION


Perampanel and brivaracetam are effective for the adjunctive treatment of focal-onset seizures and display similar adverse event profiles. Perampanel demonstrated an improved focal-onset seizure responder rate compared to brivaracetam in patients taking concomitant levetiracetam. This may be due to the similarity in the mechanism of action between brivaracetam and levetiracetam.",2020,"For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate.","['focal-onset seizures', 'patients with focal-onset seizures with or without secondary generalization', 'patients with focal-onset seizures']","['perampanel', 'perampanel versus brivaracetam', 'perampanel or brivaracetam', 'levetiracetam, perampanel', 'Perampanel', 'placebo']","['efficacy and safety outcomes', 'dizziness', 'responder rate', 'responder rate, seizure freedom, and secondarily generalized tonic-clonic seizure responder rate', 'efficacy and safety', 'focal-onset seizure responder rate']","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}]",,0.188512,"For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate.","[{'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Trinka', 'Affiliation': 'FRCP Department of Neurology, Christian Doppler University Hospital, Paracelsus Medical University, Harrerstrasse 79, A-5020, Salzburg, Austria. Electronic address: eugen@trinka.at.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Tsong', 'Affiliation': 'Formerly Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ, 07677, United States. Electronic address: wtsong.esi@gmail.com.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Toupin', 'Affiliation': 'Quantics Biostatistics, Exchange Tower, 19 Canning Street Fourth Floor, Edinburgh, EH3 8EG, United Kingdom. Electronic address: sydney.toupin@outlook.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd. European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'York Health Economics Consortium, Enterprise House, Innovation Way, University of York, York, YO10 5NQ, United Kingdom. Electronic address: katy.wilson@york.ac.uk.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Isojarvi', 'Affiliation': 'York Health Economics Consortium, Enterprise House, Innovation Way, University of York, York, YO10 5NQ, United Kingdom. Electronic address: jaana.isojarvi@york.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Quantics Biostatistics, Exchange Tower, 19 Canning Street Fourth Floor, Edinburgh, EH3 8EG, United Kingdom. Electronic address: Daniel.James@quantics.co.uk.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106403']
3020,32673274,"Development of ""Advancing People of Color in Clinical Trials Now!"": Web-Based Randomized Controlled Trial Protocol.","BACKGROUND


Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of ""Advancing People of Color in Clinical Trials Now!"" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color.
OBJECTIVE


This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color.
METHODS


ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention.
RESULTS


We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020.
CONCLUSIONS


ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17589.",2020,ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website.,"['As of December 2019, we had enrolled 100 participants', 'ACT', 'people of color']","['intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website', 'culturally tailored website', 'ACT']","['clinical trial literacy, self-efficacy, and willingness']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009393', 'cui_str': 'Color'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",100.0,0.157381,ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website.,"[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Chung', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Azizi', 'Initials': 'A', 'LastName': 'Seixas', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Yalini', 'Initials': 'Y', 'LastName': 'Senathirajah', 'Affiliation': 'University of Pittsburgh, Department of Biomedical Informatics, Pittsburgh, PA, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Robbins', 'Affiliation': ""Brigham and Women's, Boston, MA, United States.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Newsome Garcia', 'Affiliation': 'Morehouse School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ravenell', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Girardin', 'Initials': 'G', 'LastName': 'Jean-Louis', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY, United States.'}]",JMIR research protocols,['10.2196/17589']
3021,32673278,Effectiveness of the InCharge Prevention Program to Promote Healthier Lifestyles: Protocol for a Randomized Controlled Trial.,"BACKGROUND


InCharge is a newly developed school-based health intervention aimed at older adolescents. It aims to promote a healthier lifestyle by increasing self-regulation skills. After the InCharge program's effectiveness was previously investigated in a pilot study, the content of the program was adapted.
OBJECTIVE


This study describes the protocol of a cluster randomized controlled trial that aims to investigate the effectiveness of the InCharge program.
METHODS


A cluster randomized controlled trial including 70 classes with older adolescents (aged 16 years or older) in the Netherlands will be conducted to test the effectiveness of the InCharge program. After schools are recruited, randomization occurs at the class level. The trial consists of the following two conditions: an experimental condition and a control condition. Participants in the experimental condition will be given the InCharge intervention, consisting of four lessons of 50 minutes, with each lesson containing three assignments of approximately 15 minutes. While participants in the experimental condition will receive InCharge, participants in the control condition will receive regular academic school courses. Surveys are administered 1 week before the intervention (baseline), 1 week after the intervention (posttest), and 12 weeks after the intervention (follow-up). Variables of interest include, but are not limited to, self-regulation; predictors of snack intake, physical activity, and alcohol use; and interpersonal communication regarding these health behaviors. In addition to surveys, observations will be conducted during the first and fourth lessons, teachers will be interviewed, and focus groups will be held with a selection of students from the intervention condition.
RESULTS


Enrollment started in September 2017. As of June 2019, a total of 1216 participants were enrolled for this trial. Findings will be published in peer-reviewed journals and presented at conferences. The trial has been approved by the Ethics Review Board of the Faculty of Social and Behavioral Sciences of the University of Amsterdam (reference no.: 2017-PC-8244).
CONCLUSIONS


In this study protocol, the design of a cluster randomized controlled trial is described, which assesses how effectively the school-based intervention InCharge stimulates healthier lifestyles in late adolescents. We hypothesize that participants in the experimental condition will consume less alcohol, eat fewer unhealthy snacks, and be more physically active compared with participants in the control condition.
TRIAL REGISTRATION


Netherlands Trial Register (NL6654); https://www.trialregister.nl/trial/6654.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/17702.",2020,"After the InCharge program's effectiveness was previously investigated in a pilot study, the content of the program was adapted.
","['As of June 2019, a total of 1216 participants were enrolled for this trial', 'late adolescents', 'older adolescents', '70 classes with older adolescents (aged 16 years or older']",['InCharge Prevention Program'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],1216.0,0.164809,"After the InCharge program's effectiveness was previously investigated in a pilot study, the content of the program was adapted.
","[{'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Mesman', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Onrust', 'Affiliation': 'Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Verkerk', 'Affiliation': 'Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Hendriks', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Van den Putte', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}]",JMIR research protocols,['10.2196/17702']
3022,32673356,Comparing feasibility of low-tube-voltage protocol with low-iodine-concentration contrast and high-tube-voltage protocol with high-iodine-concentration contrast in coronary computed tomography angiography.,"BACKGROUND


To investigate the feasibility of a low tube voltage (80 kVp) protocol with low concentration contrast media (CM) (iodixanol 320 mgl/ml) as compared with a high tube voltage (100 kVp) protocol with high concentration CM (iomeprol 400 mgl/ml) in coronary CT angiography (CCTA) for patients with body mass index less than 30.
MATERIALS AND METHODS


A total of 93 patients were randomly assigned into three groups and underwent CCTA as follows: Group A) 100 kVp, 100-350 mAs, 400 mgl/ml CM at 4ml/s, and reconstructed with filtered back projection; Group B and C) 80 kVp, 100-450 mAs, 320 mgl/ml CM at 4 ml/s and 5 ml/s, respectively and reconstructed with iterative reconstruction. Objective and subjective image quality (IQ) was analyzed.
RESULTS


The image noise, intravascular attenuation, signal-to-noise ratio and contrast-to-noise ratio of major coronary arteries did not differ significantly among three groups. Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05). Qualitative IQ of Group B and C was non-inferior to that of Group A. Substantial reduction of radiation exposure was achieved in group B (2.60 ± 0.48 mSv) and C (2.72 ± 0.54 mSv), compared with group A (3.58 ± 0.67 mSv) (p < 0.05).
CONCLUSION


CCTA at 80 kVp with 320 mgl/ml CM and iterative reconstruction is feasible, achieving radiation dose reduction, while preserving IQ.",2020,"Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05).","['patients with body mass index less than 30', 'A total of 93 patients']","['low tube voltage (80 kVp) protocol with low concentration contrast media (CM) (iodixanol 320 mgl/ml) as compared with a high tube voltage (100 kVp) protocol with high concentration CM (iomeprol 400 mgl/ml) in coronary CT angiography (CCTA', 'CCTA', 'low-tube-voltage protocol with low-iodine-concentration contrast and high-tube-voltage protocol with high-iodine-concentration contrast in coronary computed tomography angiography']","['radiation exposure', 'Objective and subjective image quality (IQ', 'image noise, intravascular attenuation, signal-to-noise ratio and contrast-to-noise ratio of major coronary arteries', 'vascular attenuation and image noise']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2350056', 'cui_str': 'iodixanol-320'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0635652', 'cui_str': 'iomeprol 400'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",93.0,0.0341413,"Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05).","[{'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Cha', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Mok', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Ran', 'Initials': 'TR', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yeon Hyeon', 'Initials': 'YH', 'LastName': 'Choe', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0236108']
3023,32673417,"Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial.","BACKGROUND


CheckMate 025 has shown superior efficacy for nivolumab over everolimus in patients with advanced renal cell carcinoma (aRCC) along with improved safety and tolerability. This analysis assesses the long-term clinical benefits of nivolumab versus everolimus.
METHODS


The randomized, open-label, phase 3 CheckMate 025 trial (NCT01668784) included patients with clear cell aRCC previously treated with 1 or 2 antiangiogenic regimens. Patients were randomized to nivolumab (3 mg/kg every 2 weeks) or everolimus (10 mg once a day) until progression or unacceptable toxicity. The primary endpoint was overall survival (OS). The secondary endpoints were the confirmed objective response rate (ORR), progression-free survival (PFS), safety, and health-related quality of life (HRQOL).
RESULTS


Eight hundred twenty-one patients were randomized to nivolumab (n = 410) or everolimus (n = 411); 803 patients were treated (406 with nivolumab and 397 with everolimus). With a minimum follow-up of 64 months (median, 72 months), nivolumab maintained an OS benefit in comparison with everolimus (median, 25.8 months [95% CI, 22.2-29.8 months] vs 19.7 months [95% CI, 17.6-22.1 months]; hazard ratio [HR], 0.73; 95% CI, 0.62-0.85) with 5-year OS probabilities of 26% and 18%, respectively. ORR was higher with nivolumab (94 of 410 [23%] vs 17 of 411 [4%]; P < .001). PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72-0.99; P = .0331). The most common treatment-related adverse events of any grade were fatigue (34.7%) and pruritus (15.5%) with nivolumab and fatigue (34.5%) and stomatitis (29.5%) with everolimus. HRQOL improved from baseline with nivolumab but remained the same or deteriorated with everolimus.
CONCLUSIONS


The superior efficacy of nivolumab over everolimus is maintained after extended follow-up with no new safety signals, and this supports the long-term benefits of nivolumab monotherapy in patients with previously treated aRCC.
LAY SUMMARY


CheckMate 025 compared the effects of nivolumab (a novel immunotherapy) with those of everolimus (an older standard-of-care therapy) for the treatment of advanced kidney cancer in patients who had progressed on antiangiogenic therapy. After 5 years of study, nivolumab continues to be better than everolimus in extending the lives of patients, providing a long-lasting response to treatment, and improving quality of life with a manageable safety profile. The results demonstrate that the clinical benefits of nivolumab versus everolimus in previously treated patients with advanced kidney cancer continue in the long term.",2020,"PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72-0.99; P = .0331).","['patients with clear cell aRCC previously treated with 1 or 2 antiangiogenic regimens', 'patients with advanced renal cell carcinoma', 'Eight hundred twenty-one patients', 'advanced kidney cancer in patients who had progressed on antiangiogenic therapy', 'patients with advanced renal cell carcinoma (aRCC', 'n\xa0=\xa0411); 803 patients were treated (406 with', 'patients with previously treated aRCC']","['nivolumab over everolimus', 'nivolumab and 397 with everolimus', 'nivolumab', 'everolimus', 'Nivolumab versus everolimus', 'nivolumab monotherapy', 'nivolumab versus everolimus']","['quality of life', 'HRQOL', 'safety and tolerability', 'ORR', '5-year OS probabilities', 'overall survival (OS', 'pruritus', 'objective response rate (ORR), progression-free survival (PFS), safety, and health-related quality of life (HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0596087', 'cui_str': 'Angiogenesis inhibitor'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",821.0,0.256141,"PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72-0.99; P = .0331).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Division of Hematology and Oncology, UT Southwestern Kidney Cancer Program, Dallas, Texas.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Srinivas', 'Affiliation': 'Stanford Cancer Institute, Stanford University Medical Center, Stanford, California.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sosman', 'Affiliation': 'Department of Hematology/Oncology, Northwestern University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Procopio', 'Affiliation': 'Fondazione Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Oncologia Medica, Hospital Universitario 12 De Octubre, Madrid, Spain.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Westmead, New South Wales, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Service de Cancérologie Médicale, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Richardet', 'Affiliation': 'Fundacion Richardet Longo, Instituto Oncologico de Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Katriina', 'Initials': 'K', 'LastName': 'Peltola', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ajjai S', 'Initials': 'AS', 'LastName': 'Alva', 'Affiliation': 'Division of Hematology and Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Carducci', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'South West Wales Cancer Institute and Swansea University College of Medicine, Swansea, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, France.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fukasawa', 'Affiliation': 'Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Gauler', 'Affiliation': 'Department of Medicine, University Hospital Essen, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, BC Cancer-Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Schutz', 'Affiliation': 'Beneficencia Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Department of Biostatistics, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Shruti Shally', 'Initials': 'SS', 'LastName': 'Saggi', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.33033']
3024,32673446,Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors.,"The impact of repeated daily 500-mg fedratinib (an oral selective Janus kinase [JAK] 2 inhibitor) on QTc and other electrocardiogram (ECG) parameters was assessed in 60 patients with advanced solid tumors. Patients received placebo on day 1 and fedratinib 500 mg daily for 14 days. Concentration-QTc analysis was performed with change-from-baseline QTc corrected by Fridericia's formula (ΔQTcF) as the dependent variable. Fedratinib median time to maximum plasma concentration (C max  ) was observed 3 hours postdose on day 15. The largest difference between means for fedratinib and placebo was 0.5 bpm (90%CI, -2.75 to 3.72 bpm) for heart rate (3 hours postdose) and 4.3 milliseconds (90%CI, 1.04-7.60 milliseconds) for QTcF (4 hours postdose). The estimated slope of the fedratinib concentration-QTcF relationship was shallow and not statistically significant: -0.0005 milliseconds per ng/mL (90%CI, -0.00145 to 0.00050 milliseconds per ng/mL). Predicted fedratinib placebo-corrected ΔQTcF was 0.6 milliseconds (90%CI, -1.80 to 2.93 milliseconds) at the geometric mean of the observed C max  (3615 ng/mL). Fedratinib did not affect PR or QRS intervals. No patients had QTcF > 60 milliseconds, and no patients experienced QTcF ≥ 500 milliseconds. Fedratinib did not cause clinically relevant ECG effects or QTc prolongation. Safety findings were consistent with the known safety profile.",2020,Fedratinib did not cause clinically relevant ECG effects or QTc prolongation.,"['Patients With Advanced Solid Tumors', '60 patients with advanced solid tumors']","['placebo-corrected ΔQTcF', 'placebo']","['Fedratinib median time to maximum plasma concentration (C max  ', 'heart rate', 'QTc and other electrocardiogram (ECG) parameters', 'fedratinib concentration-QTcF relationship', 'PR or QRS intervals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}]",60.0,0.275115,Fedratinib did not cause clinically relevant ECG effects or QTc prolongation.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Carayannopoulos', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.850']
3025,32678530,Dexamethasone in Hospitalized Patients with Covid-19 - Preliminary Report.,"BACKGROUND


Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.
METHODS


In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison.
RESULTS


A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).
CONCLUSIONS


In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.).",2020,"In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).
","['Hospitalized Patients with Covid-19 - Preliminary Report', '2104 patients', 'patients who were hospitalized with Covid-19']","['usual care alone', 'dexamethasone and 4321 to receive usual care', 'dexamethasone', 'Glucocorticoids', 'invasive mechanical ventilation or oxygen alone', 'oral or intravenous dexamethasone', 'Dexamethasone']","['incidence of death', 'mortality', '28-day mortality', 'receiving oxygen without invasive mechanical ventilation']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]",2104.0,0.237066,"In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Emberson', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Staplin', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Brightling', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chadwick', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Kanchan', 'Initials': 'K', 'LastName': 'Rege', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Fegan', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Jeffery', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': ""From the Nuffield Department of Medicine (P.H.), Nuffield Department of Population Health (J.R.E., M.M., J.L.B., L.L., N.S., E.J., R.H., M.J.L.), and MRC Population Health Research Unit (J.R.E., N.S., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J.), and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M.), Nottingham, the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester (C.B.), the Regional Infectious Diseases Unit, North Manchester General Hospital and University of Manchester (A.U.), and the University of Manchester and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (C.G.), the Centre for Clinical Infection, James Cook University Hospital, Middlesbrough (D.C.), the North West Anglia NHS Foundation Trust, Peterborough (K. Rege), the Department of Research and Development, Cardiff and Vale University Health Board, Cardiff (C.F.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K. Rowan), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.) - all in the United Kingdom.""}]",The New England journal of medicine,['10.1056/NEJMoa2021436']
3026,32664996,Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation.,,2020,,['patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation'],[],['Cytokine adsorption'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}]",[],"[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001674', 'cui_str': 'Adsorption'}]",,0.0551243,,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Rieder', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Wengenmayer', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Staudacher', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duerschmied', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Supady', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany. alexander.supady@universitaets-herzzentrum.de.'}]","Critical care (London, England)",['10.1186/s13054-020-03130-y']
3027,32673552,Exogenous testosterone increases the audience effect in healthy males: evidence for the social status hypothesis.,"Several studies have implicated testosterone in the modulation of altruistic behaviours instrumental to advancing social status. Independent studies have also shown that people tend to behave more altruistically when being watched (i.e. audience effect). To date, little is known about whether testosterone could modulate the audience effect. In the current study, we tested the effect of testosterone on altruistic behaviour using a donation task, wherein participants were asked to either accept or reject a monetary transfer to a charity organization accompanying a personal cost either in the presence or absence of an observer. We administered testosterone gel or placebo to healthy young men ( n  = 140) in a double-blind, placebo-controlled, mixed design. Our results showed that participants were more likely to accept the monetary transfer to the charity when being observed compared to when they completed the task alone. More importantly, this audience effect was amplified among people receiving testosterone versus placebo. Our findings suggest that testosterone administration increases the audience effect and further buttress the social status hypothesis, according to which testosterone promotes status-seeking behaviour in a context-dependent manner.",2020,"In the current study, we tested the effect of testosterone on altruistic behaviour using a donation task, wherein participants were asked to either accept or reject a monetary transfer to a charity organization accompanying a personal cost either in the presence or absence of an observer.","['healthy young men ( n  = 140', 'healthy males']","['testosterone gel or placebo', 'testosterone', 'Exogenous testosterone', 'placebo']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}]",[],,0.132428,"In the current study, we tested the effect of testosterone on altruistic behaviour using a donation task, wherein participants were asked to either accept or reject a monetary transfer to a charity organization accompanying a personal cost either in the presence or absence of an observer.","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""School of Psychology, Shenzhen University, Shenzhen 518060, People's Republic of China.""}, {'ForeName': 'Yinhua', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""School of Psychology, Shenzhen University, Shenzhen 518060, People's Republic of China.""}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': ""School of Psychology, Shenzhen University, Shenzhen 518060, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""School of Psychological and Cognitive Sciences, Peking University, Beijing 100871, People's Republic of China.""}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Zilioli', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, MI 48202, USA.'}]",Proceedings. Biological sciences,['10.1098/rspb.2020.0976']
3028,32673573,"Comparison of Surgical Drain Placement With Use of Kinesiologic Tape on Postoperative Pain, Swelling, and Trismus in Impacted Mandibular Third Molar Surgery.","PURPOSE


The aim of this prospective study was to compare the effects of a surgical tube drain with kinesiologic tape (KT) application on postoperative complications such as trismus, swelling, and pain after impacted third molar surgery.
PATIENTS AND METHODS


This single-center, randomized study included 90 patients divided into 3 groups. After impacted third molar removal, 30 patients were treated with a tube drain (drain group), 30 patients were treated with KT application (KT group), and 30 patients were treated with a routine surgical operation and no extra procedure (control group).
RESULTS


A total of 29 male and 61 female patients were included. Mouth opening was greatest in the drain group over a period of 7 days. Patients in the control group had more pain than those in the drain and KT groups. No statistically significant difference was found in terms of pain and swelling between the drain and KT groups over the 7-day period of the study. The tube drain was found to improve patients' quality of life compared with the KT and control groups.
CONCLUSIONS


Although the effects of a tube drain and KT in terms of pain and swelling were similar, the tube drain was more effective in reducing postoperative complications.",2020,No statistically significant difference was found in terms of pain and swelling between the drain and KT groups over the 7-day period of the study.,"['90 patients divided into 3 groups', 'A total of 29 male and 61 female patients were included']","['Surgical Drain Placement', 'Kinesiologic Tape', 'tube drain and KT', 'KT application', 'surgical tube drain with kinesiologic tape (KT) application', 'tube drain', 'routine surgical operation and no extra procedure (control group']","['Postoperative Pain, Swelling, and Trismus', ""patients' quality of life"", 'postoperative complications such as trismus, swelling, and pain', 'pain and swelling', 'postoperative complications', 'pain', 'Mouth opening']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2607832', 'cui_str': 'Surgical drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}]",90.0,0.0266718,No statistically significant difference was found in terms of pain and swelling between the drain and KT groups over the 7-day period of the study.,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Menziletoglu', 'Affiliation': 'Assistant Professor, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey. Electronic address: drdilekmenziletoglu@gmail.com.'}, {'ForeName': 'Arif Yigit', 'Initials': 'AY', 'LastName': 'Guler', 'Affiliation': 'Research Assistant, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Basturk', 'Affiliation': 'Research Assistant, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Bozkurt Kubilay', 'Initials': 'BK', 'LastName': 'Isik', 'Affiliation': 'Professor and Department Head, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.06.023']
3029,32678954,Short-term comparison of two non-surgical treatments modalities of peri-implantitis. Clinical and microbiological outcomes in a two-factorial randomised controlled trial.,"AIM


To compare the efficacy of two different therapies (amino acid glycine abrasive powder and a desiccant material) and their combination in the non-surgical treatment of peri-implantitis.
MATERIALS AND METHODS


This was an examiner-blind randomised clinical trial, with 2-factorial design with a follow-up of 6 months. The combination of the two factors resulted in four interventions: 1.Non-surgical debridement alone (C); 2.Non-surgical debridement and a desiccant material (H); 3.Non-surgical debridement and glycine powder (G); 4.Non-surgical debridement, desiccant material and glycine powder (HG).
RESULTS


Sixty-four patients with peri-implantitis were randomised, 16 for each intervention. After six months, two implants failed in the G intervention. Mean pocket depth reduction was higher in patients treated with the desiccant material (estimated difference 0.5mm, 95%CI from 0.1 to 0.9mm, p=0.0229) while there was no difference in the patients treated with glycine powder (estimated difference 0.1mm, 95%CI from -0.3 to 0.5mm, p=0.7333). VAS for pain during intervention and VAS for pain after one week were higher for patients treated with glycine powder (p=0.0056 and p=0.0339 respectively). The success criteria and other variables did not reveal differences between interventions.
CONCLUSIONS


In this 6-month follow-up study, pocket reduction was more pronounced in patients using the desiccant material. Pain was higher in patients using glycine. All the interventions resulted in low success rate.",2020,"In this 6-month follow-up study, pocket reduction was more pronounced in patients using the desiccant material.","['Sixty-four patients with peri-implantitis', 'peri-implantitis']","['surgical debridement alone (C); 2.Non-surgical debridement and a desiccant material (H); 3.Non-surgical debridement and glycine powder (G); 4.Non-surgical debridement, desiccant material and glycine powder (HG', 'therapies (amino acid glycine abrasive powder and a desiccant material', 'VAS', 'glycine powder']","['low success rate', 'Pain', 'Mean pocket depth reduction']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C2936384', 'cui_str': 'Drying Agents'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",64.0,0.169204,"In this 6-month follow-up study, pocket reduction was more pronounced in patients using the desiccant material.","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Merli', 'Affiliation': 'University Politecnica delle Marche, Clinica Merli, Italy, Rimini, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bernardelli', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Giulianelli', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carinci', 'Affiliation': 'Maxillofacial Surgery, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Mariotti', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Merli', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Giovanpaolo', 'Initials': 'G', 'LastName': 'Pini-Prato', 'Affiliation': 'Tuscany Academy of Dental Research (ATRO)Florence, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}]",Journal of clinical periodontology,['10.1111/jcpe.13345']
3030,32678998,"The TinMan study: feasibility trial of a psychologically informed, audiologist-delivered, manualised intervention for tinnitus.","OBJECTIVE


To develop a manualised psychological treatment for tinnitus that could enhance audiologist usual care, and to test feasibility of evaluating it in a randomised controlled trial.
DESIGN


Feasibility trial, random allocation of patients to manualised treatment or treatment as usual, and mixed-methods evaluation.  Study sample:  Senior audiologists, and adults with chronic tinnitus.
RESULTS


Recruitment reached 63% after 6 months (feasibility pre-defined as 65%). Only nine patients (47%) were retained for the duration of the trial. Patients reported that the treatment was acceptable and helped reassure them about their tinnitus. Audiologists reported mixed feelings about the kinds of techniques that are presented to them as 'psychologically informed'. Audiologists also reported lacking confidence because the training they had was brief, and stated that more formal supervision would have been helpful to check adherence to the treatment manual.
CONCLUSIONS


The study indicate potential barriers to audiologist use of the manual, and that a clinical trial of the intervention is not yet feasible. However, positive indications from outcome measures suggest that further development work would be worthwhile. Refinements to the manual are indicated, and training and supervision arrangements to better support audiologists to use the intervention in the clinic are required.  Trial Registration:  ISRCTN13059163.",2020,"Refinements to the manual are indicated, and training and supervision arrangements to better support audiologists to use the intervention in the clinic are required.  ","['Study sample:  Senior audiologists, and adults with chronic tinnitus']","['psychologically informed, audiologist-delivered, manualised intervention for tinnitus']",[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0175838', 'cui_str': 'Audiologist'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0175838', 'cui_str': 'Audiologist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]",[],,0.0704391,"Refinements to the manual are indicated, and training and supervision arrangements to better support audiologists to use the intervention in the clinic are required.  ","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK.'}, {'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, UK.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Hall', 'Affiliation': 'National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK.'}, {'ForeName': 'Dawn-Marie', 'Initials': 'DM', 'LastName': 'Walker', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McMurran', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Casey', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Featherstone', 'Affiliation': 'Clitheroe Therapies Clinic, Clitheroe, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'MacDonald', 'Affiliation': 'Department of Psychology, University of Stirling, Stirling, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stockdale', 'Affiliation': 'British Tinnitus Association, Sheffield, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hoare', 'Affiliation': 'National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK.'}]",International journal of audiology,['10.1080/14992027.2020.1788730']
3031,32674230,Clinical effects of total protein and short peptide enteral nutrition during recovery after radical gastrectomy.,"BACKGROUND AND OBJECTIVES


Enteral nutrition (EN) plays a vital role in promoting the recovery of patients after surgery. This study aims to clarify the effects of total protein enteral nutrition (TPEN) and short peptide enteral nutrition (SPEN) on the recovery of patients after radical gastrectomy.
METHODS AND STUDY DESIGN


Patients underwent radical gastrectomy were randomly divided into a TPEN (n=60) or SPEN group (n=60). These two kinds of EN were fed 24 hours after radical gastrectomy with increasing dose from 10 kcal/kg to maximal 25 kcal/kg on postoperative day (POD) 5 and with the maximal dose in following days. Supplemental parenteral nutrition was given for replenishing energy deficits. The tube feeding was discontinued when oral intake increased to sixty percent of the target requirements. The postoperative recovery was evaluated on POD 1 and POD 7.
RESULTS


On POD 7, the serum prealbumin (transthyretin) was higher in the TPEN than the SPEN group (p<0.001). The patients in the TPEN group had a higher incidence of abdominal distension (p=0.043), but had a lower incidence of diarrhea (p=0.016) compared to the SPEN group. The anal exhaust time of patients in the TPEN group was postponed (p=0.020), but the postoperative hospitalization time (p=0.005) and total hospitalization time (p=0.027) were shortened compared to the SPEN group. No significant differences were observed between the two groups in any other indicators.
CONCLUSIONS


SPEN is suitable for early and TPEN for later stage recovery after radical gastrectomy.",2020,"The patients in the TPEN group had a higher incidence of abdominal distension (p=0.043), but had a lower incidence of diarrhea (p=0.016) compared to the SPEN group.","['Patients underwent radical gastrectomy', 'patients after radical gastrectomy', 'patients after surgery']","['SPEN', 'TPEN', 'total protein enteral nutrition (TPEN) and short peptide enteral nutrition (SPEN', 'Supplemental parenteral nutrition', 'total protein and short peptide enteral nutrition']","['diarrhea', 'total hospitalization time', 'serum prealbumin (transthyretin', 'postoperative recovery', 'abdominal distension', 'postoperative hospitalization time', 'anal exhaust time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}]",,0.0140412,"The patients in the TPEN group had a higher incidence of abdominal distension (p=0.043), but had a lower incidence of diarrhea (p=0.016) compared to the SPEN group.","[{'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of pharmacy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Nanjing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of general surgery, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of general surgery, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Nanjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of general surgery, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Nanjing, China.'}, {'ForeName': 'Huanqiu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of general surgery, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of pharmacy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Nanjing, China. Email: jsschwq@sina.com.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.202007_29(2).0005']
3032,32674231,Effect of B vitamins supplementation on cardio-metabolic factors in patients with stable coronary artery disease: A randomized double-blind trial.,"BACKGROUND AND OBJECTIVES


This study aimed to evaluate whether B vitamins supplementation would improve dyslipidemia, alleviate inflammatory state of patients with stable coronary artery disease (SCAD).
METHODS AND STUDY DESIGN


We conducted a randomized, double-blind, 12-week, placebo-controlled trial involving adults with SCAD, and who were randomly divided into B vitamins group (folic acid and VB-6) and control group (placebo tablet). Blood tests had also been performed at baseline and endpoint.
RESULTS


After 12 weeks of intervention, B vitamins supplementation significantly improved the concentration of serum TG, TC and HDL-C (p<0.05). Changes of serum homocysteine in B vitamins treatment were significantly different compared to placebo by the multivariate-adjusted analysis (3.02±2.35 vs 1.55±1.58 p<0.001). Meanwhile, the levels of IL-1β and IL-10, significant difference were observed between two groups after adjustment for confounding factors.
CONCLUSIONS


Supplementation with B vitamins significantly improves lipid metabolism, alleviate inflammation and serum homocysteine concentration in patients with SCAD.",2020,"Meanwhile, the levels of IL-1β and IL-10, significant difference were observed between two groups after adjustment for confounding factors.
","['adults with SCAD', 'patients with stable coronary artery disease (SCAD', 'patients with stable coronary artery disease', 'patients with SCAD']","['B vitamins supplementation', 'Supplementation with B vitamins', 'B vitamins group (folic acid and VB-6) and control group (placebo tablet', 'placebo']","['concentration of serum TG, TC and HDL-C (p<0.05', 'cardio-metabolic factors', 'lipid metabolism, alleviate inflammation and serum homocysteine concentration', 'serum homocysteine', 'levels of IL-1β and IL-10']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.462529,"Meanwhile, the levels of IL-1β and IL-10, significant difference were observed between two groups after adjustment for confounding factors.
","[{'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'The Institute of Human Nutrition, College of Public Health, Qingdao University, Qingdao, PR China.'}, {'ForeName': 'Zongling', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Qingdao Fuwai Cardiovascular Disease Hospital, Qingdao, PR China.'}, {'ForeName': 'Shengxin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""The Department of health statistics, College of Public Health, Tai Shan Medical University, Tai'an, PR China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'The Institute of Human Nutrition, College of Public Health, Qingdao University, Qingdao, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The basic medical college of Qingdao University, Qingdao, PR China.'}, {'ForeName': 'Meilan', 'Initials': 'M', 'LastName': 'Xue', 'Affiliation': 'The Institute of Human Nutrition, College of Public Health, Qingdao University, Qingdao, PR China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The Institute of Human Nutrition, College of Public Health, Qingdao University, Qingdao, PR China.'}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Qingdao Zhong Ren Health Management Company, Jiao Zhou, PR China.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Qingdao Community Health Center of Lao Shan Qingdao, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'The Institute of Human Nutrition, College of Public Health, Qingdao University, Qingdao, PR China. Email: qdlianghui@126.com.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.202007_29(2).0006']
3033,32674235,Accelerated rehabilitation combined with enteral nutrition in the management of lung cancer surgery patients.,"BACKGROUND AND OBJECTIVES


To investigate the effect of accelerated rehabilitation combined with enteral nutrition on surgically treated lung cancer patients.
METHODS AND STUDY DESIGN


In total, 150 lung cancer patients treated in our hospital from January 2017 to January 2018 were retrospectively analysed. Sixty-six patients were randomly divided into a control group with conventional nutrition (Con group) and an accelerated rehabilitation combined with enteral nutrition group (EN group). Postoperative drainage; total hospitalization time; total hospitalization expenses; and albumin, haemoglobin and total lymphocyte counts (TLC) before and after treatment were compared.
RESULTS


The serum albumin, prealbumin and haemoglobin in both groups were decreased after operation and were significantly higher in the EN group (p<0.05) than in the Con group. The TLC decreased in both groups after operation and were significantly higher in the EN group than in the con group. The postoperative drainage volume, total hospitalization time and total hospitalization expenses were significantly lower in the EN group than in the Con group (p<0.05).
CONCLUSIONS


The effect of accelerated rehabilitation combined with enteral nutrition in lung cancer surgery patients is clear. Surgery leads to stress, which enhances catabolism and reduces the synthesis of carbohydrates, protein, and fat, increasing patients' nutritional risk. Nutritional support combined with fast-track minimally invasive thoracic surgery for at-risk lung cancer patients who undergo preoperative nutritional screening and assessment can reduce postoperative complications and hospitalization time and improve nutritional indicators, immunity, respiratory function recovery and clinical outcomes, leading to socioeconomic benefits.",2020,"The serum albumin, prealbumin and haemoglobin in both groups were decreased after operation and were significantly higher in the EN group (p<0.05) than in the Con group.","['150 lung cancer patients treated in our hospital from January 2017 to January 2018 were retrospectively analysed', 'Sixty-six patients', 'surgically treated lung cancer patients', 'at-risk lung cancer patients', 'lung cancer surgery patients']","['accelerated rehabilitation combined with enteral nutrition', 'control group with conventional nutrition (Con group) and an accelerated rehabilitation combined with enteral nutrition group (EN group', 'Accelerated rehabilitation combined with enteral nutrition', 'Nutritional support combined with fast-track minimally invasive thoracic surgery']","['TLC', 'postoperative drainage volume, total hospitalization time and total hospitalization expenses', 'Postoperative drainage; total hospitalization time; total hospitalization expenses; and albumin, haemoglobin and total lymphocyte counts (TLC', 'postoperative complications and hospitalization time and improve nutritional indicators, immunity, respiratory function recovery and clinical outcomes, leading to socioeconomic benefits', 'serum albumin, prealbumin and haemoglobin']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}]",150.0,0.017506,"The serum albumin, prealbumin and haemoglobin in both groups were decreased after operation and were significantly higher in the EN group (p<0.05) than in the Con group.","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Nutrition Department, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Nutrition Department, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Nutrition Department, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China.'}, {'ForeName': 'Zhi-Yan', 'Initials': 'ZY', 'LastName': 'Qi', 'Affiliation': 'Nutrition Department, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Nutrition Department, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Thoracic Surgery Department, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Thoracic Surgery Department, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China. Email: jiangleiem@aliyun.com.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.202007_29(2).0010']
3034,32674237,"Effects of consuming red furu (fermented bean curd) on serum vitamin B-12, homocysteine and other cardiometabolic risk factors in young healthy volunteers: A randomized controlled trial.","BACKGROUND AND OBJECTIVES


The health benefits of red furu in young, healthy volunteers had not been adequately investigated. The aim of this study was to determine the effect of a single meal containing red furu on serum vitamin B-12 (B-12), homocysteine and other cardiometabolic risk factors compared with that of tofu.
METHODS AND STUDY DESIGN


Twenty-three healthy volunteers from Zhejiang University, China, were randomly assigned to two groups of consumption, either red furu (n=11, 5 women and 6 men) or tofu (n=12, 6 women and 6 men). Volunteers consumed one breakfast meal composed of either 50 g of red furu (intervention group) or 50 g of tofu (non-active comparison group) with two slices of bread. Fasting blood was collected at 0 h, 24 h, and 72 h. Standard methods were used to measure the volunteers' biochemical parameters.
RESULTS


The consumption of 50 g of red furu a day did not significantly affect serum B-12 and showed a non-significant trend to reduce serum homocysteine. In the red furu group, but not in tofu group, serum concentrations of B-12 and folate were negatively associated with homocysteine, and B-12 was positively associated with folate.
CONCLUSIONS


A breakfast meal with 50 g of red furu containing 0.096 μg of B-12 did not increase serum B-12 in healthy volunteers. These results suggested that one meal containing B-12 could be sufficient to reduce serum Hcy.",2020,The consumption of 50 g of red furu a day did not significantly affect serum B-12 and showed a non-significant trend to reduce serum homocysteine.,"['Twenty-three healthy volunteers from Zhejiang University, China, were randomly assigned to two groups of consumption, either red furu (n=11, 5 women and 6 men) or tofu (n=12, 6 women and 6 men', 'young healthy volunteers', 'healthy volunteers', 'young, healthy volunteers']","['breakfast meal composed of either 50 g of red furu (intervention group) or 50 g of tofu (non-active comparison group) with two slices of bread', 'consuming red furu (fermented bean curd', 'single meal containing red furu']","['serum vitamin B-12 (B-12), homocysteine and other cardiometabolic risk factors', 'serum Hcy', 'serum concentrations of B-12 and folate', 'Fasting blood', 'serum vitamin B-12, homocysteine and other cardiometabolic risk factors', 'serum B-12', 'homocysteine, and B-12', 'serum homocysteine']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453233', 'cui_str': 'Tofu'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453233', 'cui_str': 'Tofu'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0558296', 'cui_str': 'Curds'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",23.0,0.0903828,The consumption of 50 g of red furu a day did not significantly affect serum B-12 and showed a non-significant trend to reduce serum homocysteine.,"[{'ForeName': 'Tshenolo', 'Initials': 'T', 'LastName': 'Tsheko', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, China.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, China.'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Tong', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, China.'}, {'ForeName': 'Renke', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, China. Email: duoli@zju.edu.cn; duoli@qdu.edu.cn.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.202007_29(2).0012']
3035,32674241,Promotion of optimized food-based recommendations to improve dietary practices and nutrient intakes among Minangkabau women of reproductive age with dyslipidemia.,"BACKGROUND AND OBJECTIVES


Using a linear programming approach, an optimized food-based recommendations (FBRs) had been formulated for Minangkabau women of reproductive age with dyslipidemia in Indonesia. This study aimed to assess the effectiveness of the promotion of the FBRs for improving dietary practices and nutrient intakes.
METHODS AND STUDY DESIGN


A community-based, clustered-randomized trial was conducted among Minangkabau women of reproductive age (20-44 years) with dyslipidemia. The subjects were assigned either into the FBR group (n=48), or the non-FBR group (n=54). Baseline and end-line dietary data were assessed through interviews using a one-week semiquantitative food frequency questionnaire (SQ-FFQ) and two replicate 24-hour dietary recalls. The changes in dietary practice and nutrient intakes were analysed using ANCOVA test.
RESULTS


Significant changes were observed (p<0.005) in the consumption of the promoted food items and subgroups (sea fish, soy protein, dark green leafy vegetables, and potatoes). Significant changes were also observed in nutrient intake, especially energy intake from carbohydrates and unsaturated fatty acids (total PUFA, MUFA, n-3 and n-6 fatty acids), as well as the dietary P/S ratio and fiber intake.
CONCLUSIONS


With current dietary practices, intakes of some typical problem nutrients such as n-6, zinc, iron, and fiber still could not achieve 100% of the RNIs, while the intake of SFA still exceeded the recommended intake. Further approaches are needed to expand the population food basket and promote behavioral change to address established cultural food habits, including reducing the use of cooking oil in food preparation and increasing vegetable consumption.",2020,"RESULTS


Significant changes were observed (p<0.005) in the consumption of the promoted food items and subgroups (sea fish, soy protein, dark green leafy vegetables, and potatoes).","['Minangkabau women of reproductive age (20-44 years) with dyslipidemia', 'Minangkabau women of reproductive age with dyslipidemia in Indonesia', 'Minangkabau women of reproductive age with dyslipidemia']",['FBR'],"['nutrient intake, especially energy intake from carbohydrates and unsaturated fatty acids (total PUFA, MUFA, n-3 and n-6 fatty acids), as well as the dietary P/S ratio and fiber intake', 'dietary practice and nutrient intakes', 'consumption of the promoted food items and subgroups (sea fish, soy protein, dark green leafy vegetables, and potatoes']","[{'cui': 'C0574377', 'cui_str': 'Minangkabau language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]",[],"[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0074926', 'cui_str': 'Soy Proteins'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0032846', 'cui_str': 'Potato'}]",,0.0385331,"RESULTS


Significant changes were observed (p<0.005) in the consumption of the promoted food items and subgroups (sea fish, soy protein, dark green leafy vegetables, and potatoes).","[{'ForeName': '', 'Initials': '', 'LastName': 'Gusnedi', 'Affiliation': 'Department of Nutrition, Health Ministry Polytechnic of Padang, West Sumatra, Indonesia. Email: gusnedi02@gmail.com, gusnedi@poltekkes-pdg.ac.id.'}, {'ForeName': 'Murdani', 'Initials': 'M', 'LastName': 'Abdullah', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Fiastuti', 'Initials': 'F', 'LastName': 'Witjaksono', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Muchtaruddin', 'Initials': 'M', 'LastName': 'Mansyur', 'Affiliation': 'Southeast Asian Ministers of Education Organization Regional Centre for Food and Nutrition (SEAMEORECFON)- Pusat Kajian Gizi Regional (PKGR) Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Fariz', 'Initials': 'F', 'LastName': 'Nurwidya', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Djuwita', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Cesilia Meti', 'Initials': 'CM', 'LastName': 'Dwiriani', 'Affiliation': 'Department of Community Nutrition, Faculty of Human Ecology, Bogor Agricultural University, Indonesia.'}, {'ForeName': 'Umi', 'Initials': 'U', 'LastName': 'Fahmida', 'Affiliation': 'Southeast Asian Ministers of Education Organization Regional Centre for Food and Nutrition (SEAMEORECFON)- Pusat Kajian Gizi Regional (PKGR) Universitas Indonesia, Jakarta, Indonesia.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.202007_29(2).0016']
3036,32674248,Sodium reduction in South Korean restaurants: A Daegu-based intervention project.,"BACKGROUND AND OBJECTIVES


Koreans tend to have high sodium intake in restaurants. This study assessed the effect of the sodium reduction project in restaurants in Daegu Metropolitan City.
METHODS AND STUDY DESIGN


A total of 156 sodium reduction menu items offered by 90 restaurants were categorized into 11 food groups to compare sodium content and salinity before and after the project. In total, 162 owners and staff members of the restaurants, as well as 727 of their customers, were surveyed on their perceptions of and satisfaction with the sodium reduction project.
RESULTS


Average salinity of the menu items was significantly reduced from 0.70% prior to the project to 0.49% after the project (p<0.001), and average sodium content was also significantly reduced from 1,470 mg to 980 mg (p<0.001). The food groups with the highest sodium reduction rate were soups (46.0%) and grilled dishes (39.5%), with an average sodium reduction rate of 36.1%. The restaurant owners' average satisfaction score with the project was 39.6 points (out of 50). Customers responded that the sodium reduction menus were moderate (62.4%) and bland (27.9%), and the taste was good (48.9%) and excellent (25.0%). Approximately 52.0% and 18.6% of customers were satisfied and very satisfied, respectively, with the sodium reduction menu.
CONCLUSIONS


Overall, the sodium reduction project in restaurants in Daegu had a positive effect because it successfully reduced the sodium content of food while also boosting the satisfaction of the restaurant owners and staff and their customers with the project.",2020,"RESULTS


Average salinity of the menu items was significantly reduced from 0.70% prior to the project to 0.49% after the project (p<0.001), and average sodium content was also significantly reduced from 1,470 mg to 980 mg (p<0.001).","['restaurants in Daegu Metropolitan City', 'South Korean restaurants', 'In total, 162 owners and staff members of the restaurants, as well as 727 of their customers, were surveyed on their perceptions of and satisfaction with the sodium reduction project']",['sodium reduction project'],"['highest sodium reduction rate', 'average sodium content']","[{'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0155314,"RESULTS


Average salinity of the menu items was significantly reduced from 0.70% prior to the project to 0.49% after the project (p<0.001), and average sodium content was also significantly reduced from 1,470 mg to 980 mg (p<0.001).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Food Science and Nutrition, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Food Science and Nutrition, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Kilye', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Nutrition, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Yeon-Kyung', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Food Science and Nutrition, Kyungpook National University, Daegu, South Korea. Email: yklee@knu.ac.kr.'}]",Asia Pacific journal of clinical nutrition,['10.6133/apjcn.202007_29(2).0023']
3037,32674280,A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema.,"PURPOSE


Evaluating the effects of cibinetide in diabetic macular edema (DME).
METHODS


Phase 2 trial. Naïve patients with >400 µm central retinal thickness (CRT) DME in one/both eyes were recruited (May 2016-April 2017) at the Belfast Health and Social Care Trust. The study eye was that with best vision and lowest CRT. Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks. Primary and secondary outcomes: mean change from baseline to week 12 in best corrected visual acuity (BCVA), CRT, central retinal sensitivity, tear production, patient-reported outcomes, adverse events and antibodies to cibinetide. Descriptive statistics were used; exploratory analyses focused on non-study eyes, diabetic control, serum cytokines and albuminuria.
RESULTS


Nine patients were recruited; eight completed the study. There was no improvement in mean change baseline-week 12 in BCVA (-2.9 + 5.0), CRT (10 + 94.6 microns), central retinal sensitivity (-0.53 + 1.9 dB) or tear production (-0.13 + 7.7 mm), but there was an improvement in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores (2.7 + 3.1). Some participants experienced improvements in CRT, tear production, diabetic control and albuminuria. No serious adverse events/reactions or anti-cibinetide antibodies were seen.
CONCLUSIONS


The cibinetide 12-week course was safe. Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation.
TRIAL REGISTRATION


EudraCT number: 2015-001940-12. ISRCTN16962255-registration date 25.06.15.",2020,"Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation.
","['Diabetic Macular Edema', 'diabetic macular edema (DME', 'Naïve patients with >400 µm central retinal thickness (CRT) DME in one/both eyes were recruited (May 2016-April 2017) at the Belfast Health and Social Care Trust', 'Nine patients were recruited; eight completed the study']","['Cibinetide', 'cibinetide']","['NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria', 'central retinal sensitivity', 'corrected visual acuity (BCVA), CRT, central retinal sensitivity, tear production, patient-reported outcomes, adverse events and antibodies to cibinetide', 'National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores', 'tear production', 'CRT, tear production, diabetic control and albuminuria', 'diabetic control, serum cytokines and albuminuria', 'mean change baseline-week 12 in BCVA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4519283', 'cui_str': 'cibinetide'}]","[{'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0423153', 'cui_str': 'Lacrimation'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4519283', 'cui_str': 'cibinetide'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]",9.0,0.0339834,"Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation.
","[{'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Lois', 'Affiliation': 'The Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.'}, {'ForeName': 'Evie', 'Initials': 'E', 'LastName': 'Gardner', 'Affiliation': 'The Northern Ireland Clinical Trials Unit (NICTU), 1st Floor, Elliott Dynes Centre, Royal Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McFarland', 'Affiliation': 'Pharmacy Department, Royal Group of Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Armstrong', 'Affiliation': 'The Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McNally', 'Affiliation': 'The Northern Ireland Clinical Trials Unit (NICTU), 1st Floor, Elliott Dynes Centre, Royal Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'Nuala Jane', 'Initials': 'NJ', 'LastName': 'Lavery', 'Affiliation': 'The Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'The Northern Ireland Clinical Trials Unit (NICTU), 1st Floor, Elliott Dynes Centre, Royal Hospitals, Belfast BT12 6BA, UK.'}, {'ForeName': 'Rita I', 'Initials': 'RI', 'LastName': 'Kirk', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Bajorunas', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Dunne', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cerami', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brines', 'Affiliation': 'Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA.'}]",Journal of clinical medicine,['10.3390/jcm9072225']
3038,32674351,The Use of Different Modes of Post-Activation Potentiation (PAP) for Enhancing Speed of the Slide-Step in Basketball Players.,"Background : This study aimed to determine whether 5% of body mass-resisted or assisted conditioning activity (CA) can enhance 5 m slide-step movement performance.  Methods : Sixteen division I basketball players participated in this study (23.6 ± 4.4 years; 86.3 ± 5.9 kg; 192.3 ± 6.2 cm; training experience 6.7 ± 2.6 years). The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols-assisted and resisted CA each consisting of four sets of 10 m slide-step movement with 5% of body mass external load and 1 min rest intervals between. To assess the differences between baseline and post-assisted, as well as post-resisted CA, the participants performed a 2 × 5 m slide-step movement 6 min after each CA protocol. The differences in time between baseline, post-assisted and post-resisted CA were examined using repeated-measures ANOVA.  Results : ANOVA indicated a statistically significant difference between baseline and post-assisted postactivation performance enhancement (PAPE) ( p  = 0.011). There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  Conclusion : Findings of the study show that a light load assisted CA (5% of body mass) effectively elicits a potentiation response among basketball players.",2020,There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  ,"['Sixteen division I basketball players participated in this study (23.6 ± 4.4 years; 86.3 ± 5.9 kg; 192.3 ± 6.2 cm; training experience 6.7 ± 2.6 years', 'Basketball Players']","[' ', 'body mass-resisted or assisted conditioning activity (CA', 'Different Modes of Post-Activation Potentiation (PAP', 'light load assisted CA']",['postactivation performance enhancement (PAPE'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]",,0.0797312,There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  ,"[{'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Golas', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Zajac', 'Affiliation': 'Human Performance Laboratory, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145057']
3039,32674392,Benefits and Costs of a Community-Led Total Sanitation Intervention in Rural Ethiopia-A Trial-Based ex post Economic Evaluation.,"We estimated the costs and benefits of a community-led total sanitation (CLTS) intervention using the empirical results from a cluster-randomized controlled trial in rural Ethiopia. We modelled benefits and costs of the intervention over 10 years, as compared to an existing local government program. Health benefits were estimated as the value of averted mortality due to diarrheal disease and the cost of illness arising from averted diarrheal morbidity. We also estimated the value of time savings from avoided open defecation and use of neighbours' latrines. Intervention delivery costs were estimated top-down based on financial records, while recurrent costs were estimated bottom-up from trial data. We explored methodological and parameter uncertainty using one-way and probabilistic sensitivity analyses. Avoided mortality accounted for 58% of total benefits, followed by time savings from increased access to household latrines. The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960). The sources of the largest uncertainty in one-way sensitivity analyses were the effect of the CLTS intervention and the assumed lifespan of an improved latrine. Our results suggest that CLTS interventions can yield favourable economic returns, particularly if follow-up after the triggering is implemented intensively and uptake of improved latrines is achieved (as opposed to unimproved).",2020,"The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960).",['rural Ethiopia'],"['Community-Led Total Sanitation Intervention', 'community-led total sanitation (CLTS) intervention', 'CLTS interventions']",['Avoided mortality'],"[{'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0617726,"The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960).","[{'ForeName': 'Seungman', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK.'}, {'ForeName': 'Sunghoon', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Good Neighbors International, Mozambique, Maputo, Mozambique.'}, {'ForeName': 'Dawit Belew', 'Initials': 'DB', 'LastName': 'Bizuneh', 'Affiliation': 'Independent Consultant, Addis Ababa, Ethiopia.'}, {'ForeName': 'Tadesse', 'Initials': 'T', 'LastName': 'Abera', 'Affiliation': 'Public Health Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Young-Ah', 'Initials': 'YA', 'LastName': 'Doh', 'Affiliation': 'Korea International Cooperation Agency, Seongnam 13449, Korea.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Korea International Cooperation Agency, Seongnam 13449, Korea.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ross', 'Affiliation': 'Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17145068']
3040,30796036,Multiplexed (18-Plex) Measurement of Signaling Targets and Cytotoxic T Cells in Trastuzumab-Treated Patients using Imaging Mass Cytometry.,"PURPOSE


Imaging mass cytometry (IMC) uses metal-conjugated antibodies to provide multidimensional, objective measurement of protein targets. We used this high-throughput platform to perform an 18-plex assessment of HER2 ICD/ECD, cytotoxic T-cell infiltration and other structural and signaling proteins in a cohort of patients treated with trastuzumab to discover associations with trastuzumab benefit.
EXPERIMENTAL DESIGN


An antibody panel for detection of 18 targets (pan-cytokeratin, HER2 ICD, HER2 ECD, CD8, vimentin, cytokeratin 7, β-catenin, HER3, MET, EGFR, ERK 1-2, MEK 1-2, PTEN, PI3K p110 α, Akt, mTOR, Ki67, and Histone H3) was used with a selection of trastuzumab-treated patients from the Hellenic Cooperative Oncology Group 10/05 trial ( n  = 180), and identified a case-control series.
RESULTS


Patients that recurred after adjuvant treatment with trastuzumab trended toward a decreased fraction of HER2 ECD pixels over threshold compared with cases without recurrence ( P  = 0.057). After exclusion of the lowest HER2 expressers, 5-year recurrence events were associated with reduced total extracellular domain (ECD)/intracellular domain (ICD) ratio intensity in tumor ( P  = 0.044). These observations are consistent with our previous work using quantitative immunofluorescence, but represent the proof on identical cell content. We also describe the association of the ECD of HER2 with CD8 T-cell infiltration on the same slide.
CONCLUSIONS


The proximity of CD8 cells as a function of the expression of the ECD of HER2 provides further evidence for the role of the immune system in the mechanism of action of trastuzumab.",2019,"RESULTS


Patients that recurred after adjuvant treatment with trastuzumab trended toward a decreased fraction of HER2 ECD pixels over threshold compared with cases without recurrence ( P  = 0.057).",['patients treated with trastuzumab to discover associations with trastuzumab benefit'],['trastuzumab'],"['total extracellular domain (ECD)/intracellular domain (ICD) ratio intensity', 'Multiplexed (18-Plex) Measurement of Signaling Targets and Cytotoxic T Cells', 'fraction of HER2 ECD pixels', '5-year recurrence events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C1506592', 'cui_str': 'herstatin protein, human'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0259546,"RESULTS


Patients that recurred after adjuvant treatment with trastuzumab trended toward a decreased fraction of HER2 ECD pixels over threshold compared with cases without recurrence ( P  = 0.057).","[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Carvajal-Hausdorf', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Patsenker', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Stanton', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Villarroel-Espindola', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Esch', 'Affiliation': 'Fluidigm Corporation, Markham, Ontario, Canada.'}, {'ForeName': 'Ruth R', 'Initials': 'RR', 'LastName': 'Montgomery', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Psyrri', 'Affiliation': 'Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Konstantine T', 'Initials': 'KT', 'LastName': 'Kalogeras', 'Affiliation': 'Translational Research Section, Hellenic Cooperative Oncology Group, Athens, Greece.'}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Kotoula', 'Affiliation': 'Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Foutzilas', 'Affiliation': 'Department of Medical Oncology, ""Papageorgiou"" Hospital, Athens, Greece.'}, {'ForeName': 'Kurt A', 'Initials': 'KA', 'LastName': 'Schalper', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Kluger', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Rimm', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut. david.rimm@yale.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2599']
3041,32672998,Effects of diagnostic disclosure and varying diagnostic terminology on social attitudes to personality disorder: An experimental vignette study.,"Personality disorder (PD) diagnosis is currently in flux, with the latest edition of the  International Classification of Diseases  proposing to overhaul PD classification. The stigma purportedly attached to PD labels is a common concern in debates about PD diagnosis. However, there is a paucity of data on the general public's attitudes to PD diagnoses. The current study used an experimental vignette method to explore (a) whether attitudes to a person displaying undesirable behavior are affected by disclosing a PD diagnosis, and (b) whether the different variants of PD diagnoses present in  Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition  and  International Classification of Diseases  elicit different social responses. Participants (n = 328) were recruited via an online platform and randomly assigned to read one of six vignettes. Vignettes described a person displaying socially undesirable behaviors, whose diagnosis was either withheld or defined as Borderline, Antisocial, Mild, Moderate, or Severe PD. Participants then completed a battery of measures assessing their attitudes to the vignette character. Relative to groups who were told of a PD diagnosis, diagnostically unaware participants were less likely to see the person's problems as biologically caused, expected the problems would be shorter in duration, and attributed the character more a greater degree of personal control over their conduct. Withholding a diagnosis also resulted in greater anger and social distance and less positive affect and pity. Between the conditions in which different diagnostic classifications were stated, the specific terminology used had minimal effect. Results suggest that disclosing a PD diagnosis may ameliorate negative responses to undesirable behavior, irrespective of the particular diagnostic terminology used. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results suggest that disclosing a PD diagnosis may ameliorate negative responses to undesirable behavior, irrespective of the particular diagnostic terminology used.","['Participants (n = 328', 'social attitudes to personality disorder']",['diagnostic disclosure and varying diagnostic terminology'],['greater anger and social distance'],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}]",328.0,0.0315764,"Results suggest that disclosing a PD diagnosis may ameliorate negative responses to undesirable behavior, irrespective of the particular diagnostic terminology used.","[{'ForeName': 'Cliodhna', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'School of Psychology, University College Dublin.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'School of Applied Psychology, University College Cork.'}]",Personality disorders,['10.1037/per0000447']
3042,32673002,Testing a deliberate practice workshop for developing appropriate responsivity to resistance markers.,"Deliberate practice (DP) is an emerging training method for improving individual performance that may be worth adapting and testing for applicability to groups, given the prevalence of group training for continuing education. This study compared an adapted DP workshop to the same traditional, non-DP workshop for managing ambivalence and resistance. The same presenter delivered the workshops to 88 randomly assigned community psychotherapists. The DP workshop involved repeated interaction with multiple recreations of resistance, with consistent group feedback especially on ideal expert performance. The control workshop was more didactic, with fewer opportunities for practice and feedback. We assessed video vignette performance and coded 20-min interviews with ambivalent interviewees from the community. Both workshops produced equivalent trainee satisfaction and significant increases in self-reported skills. However, the DP versus control group demonstrated better observer-rated skill on all performance measures postworkshop. Although skills declined to 4-month retest in both groups, the DP trainees retained their relative advantage over traditional workshop trainees. Moreover, at the 4-month follow-up, DP versus control trainees were rated as more empathic by community interviewees and self-reported practicing the skills at higher rates. These findings support the continued investigation of DP as a means for improving therapist skill in continuing education workshops. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Although skills declined to 4-month retest in both groups, the DP trainees retained their relative advantage over traditional workshop trainees.",[],['Deliberate practice (DP'],"['video vignette performance', 'self-reported skills', 'equivalent trainee satisfaction']",[],[],"[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.031815,"Although skills declined to 4-month retest in both groups, the DP trainees retained their relative advantage over traditional workshop trainees.","[{'ForeName': 'Henny A', 'Initials': 'HA', 'LastName': 'Westra', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Nikoo', 'Initials': 'N', 'LastName': 'Norouzian', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Poulin', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Coyne', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olson', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology, Ryerson University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000311']
3043,32673006,Does exposure exacerbate symptoms in veterans with PTSD and alcohol use disorder?,"OBJECTIVE


Patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are often not offered exposure therapy for PTSD due to concerns that symptoms may worsen. This study examined whether initiating exposure would cause exacerbation of PTSD, alcohol use, depression, or suicidal ideation (SI) among patients with PTSD/AUD participating in exposure therapy for PTSD.
METHOD


Veterans were randomized to either concurrent treatment of PTSD and substance use disorders using prolonged exposure (COPE) or seeking safety, a nonexposure intervention, and were included in this study if they had data to at least Session 5 available (n = 81). They completed measures of PTSD, alcohol use, and depression/SI symptom severity throughout treatment and posttreatment. The reliable exacerbation method examined the number of participants who demonstrated clinically meaningful symptom exacerbation from Sessions 3 to 5 (capturing the prepost window for the start of exposure in COPE). Hierarchical/logistic regressions examined whether treatment condition predicted exacerbation of symptoms. T tests/chi-square analyses examined whether clinical exacerbation led to worse posttreatment outcomes.
RESULTS


Few participants endorsed exacerbation in symptoms of PTSD (15.8%), alcohol use (5.1%), depression (10.2%), or SI (12.8%). No significant treatment condition differences existed. Participants who experienced symptom exacerbation had higher rates of depression posttreatment compared to those who did not experience symptom exacerbation, but there were no differences in PTSD, alcohol use, or SI.
CONCLUSIONS


Exposure therapy did not lead to more clinical exacerbation than nonexposure therapy during the course of treatment, providing support that exposure therapy should not be withheld from patients with PTSD/AUD. This was a secondary analysis. and future studies that are sufficiently powered may demonstrate different results. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Few participants endorsed exacerbation in symptoms of PTSD (15.8%), alcohol use (5.1%), depression (10.2%), or SI (12.8%).","['Veterans', 'patients with PTSD/AUD participating in exposure therapy for PTSD', 'veterans with PTSD and alcohol use disorder', 'Patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD']","['PTSD and substance use disorders using prolonged exposure (COPE) or seeking safety, a nonexposure intervention', 'nonexposure therapy']","['PTSD, alcohol use, and depression/SI symptom severity', 'rates of depression posttreatment', 'PTSD, alcohol use, depression, or suicidal ideation (SI', 'PTSD, alcohol use, or SI', 'depression']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.014912,"Few participants endorsed exacerbation in symptoms of PTSD (15.8%), alcohol use (5.1%), depression (10.2%), or SI (12.8%).","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Straus', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies.'}, {'ForeName': 'Brittany C', 'Initials': 'BC', 'LastName': 'Davis', 'Affiliation': ""James A. Haley Veteran's Hospital.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lyons', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hamblen', 'Affiliation': 'National Center for PTSD.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'National Center for PTSD.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000634']
3044,32673046,Psychological affordances help explain where a self-transcendent purpose intervention improves performance.,"Lay theory interventions instill situation-general ways of thinking, often using short reading and writing exercises, and they have led to lasting changes in behavior and performance in a wide variety of policy domains. Do they work in all contexts? We suggest that lay theory intervention effects depend on  psychological affordances , which are defined as cues that allow individuals to view a lay theory as legitimate and adaptive in that context. The present research directly and experimentally tested this hypothesis using the example of a ""purpose for learning"" lay theory intervention, which taught the lay theory that school is a place to develop skills that allow one to make progress toward self-transcendent aims. A double-blind 2 (student purpose intervention) × 2 (purpose-affording note) field experiment was conducted in a relatively low-performing public middle school in the United States. Students first received a web-based purpose for learning lay theory intervention (or a control activity), and 2 weeks later attended a class in which an assignment was accompanied by a purpose-affording note that was hand-written by a teacher (or a control note). Results showed that the purpose lay theory intervention increased performance on an English class writing assignment, but only when it was accompanied by a purpose-affording note. Exploratory analyses revealed that the effects of the manipulations were apparent among students who were at greater risk for poor performance in the class: nonnative English-speaking students. Thus short, online lay theory interventions may reduce performance gaps, provided that the contexts afford the opportunity for the proffered lay theory to seem legitimate and adaptive. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results showed that the purpose lay theory intervention increased performance on an English class writing assignment, but only when it was accompanied by a purpose-affording note.",['relatively low-performing public middle school in the United States'],['learning lay theory intervention (or a control activity'],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],,0.0178921,"Results showed that the purpose lay theory intervention increased performance on an English class writing assignment, but only when it was accompanied by a purpose-affording note.","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Reeves', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Marlone D', 'Initials': 'MD', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Steingut', 'Affiliation': 'Independent Practice.'}, {'ForeName': 'Quinn', 'Initials': 'Q', 'LastName': 'Hirschi', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'Department of Psychology.'}]",Journal of personality and social psychology,['10.1037/pspa0000246']
3045,32673048,Contextual influences on subjective alcohol response.,"Prior research demonstrates contextual influences on drug responses in both animals and humans, although studies in humans typically focus on only one aspect of context (e.g., social) and examine a limited range of subjective experiences. The current study sought to address these limitations by examining the impact of both social and physical context on the full range of subjective alcohol effects. The sample included 448 young adult social drinkers (57% male, 66.5% White) randomly assigned to consume alcohol (target blood alcohol concentration of .08 g%) or placebo in 1 of 4 contexts (solitary lab, group lab, solitary bar, group bar). Results indicated that high arousal positive (HAP) effects of alcohol (e.g., talkative, lively) were stronger in nonbar relative to bar contexts and that low arousal positive (LAP) effects (e.g., relaxed, calm) were only present in the group lab context. There were also main effects of social context such that high arousal effects (both positive and negative) were stronger in group contexts, regardless of beverage condition. These findings highlight the importance of considering context when examining alcohol effects. Studies designed to isolate pharmacological HAP effects may benefit from a nonbar setting, and studies of LAP effects might be most effective in a simulated living room or home environment, although future studies are needed to directly address this possibility. Further, studies with an explicit focus on expectancies or that need strong control for expectancies might benefit from a group context, particularly when studying high arousal effects. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"There were also main effects of social context such that high arousal effects (both positive and negative) were stronger in group contexts, regardless of beverage condition.","['448 young adult social drinkers (57% male, 66.5% White) randomly assigned to']",['consume alcohol (target blood alcohol concentration of .08 g%) or placebo'],"['low arousal positive (LAP) effects', 'subjective alcohol response', 'high arousal positive (HAP) effects of alcohol (e.g., talkative, lively']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205250', 'cui_str': 'High'}]",448.0,0.020624,"There were also main effects of social context such that high arousal effects (both positive and negative) were stronger in group contexts, regardless of beverage condition.","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Corbin', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Hartman', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Bruening', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fromme', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000415']
3046,32673215,Sun Safe Partners Online: A Pilot Randomized Controlled Clinical Trial.,"BACKGROUND


Harnessing supportive influences in close relationships is an innovative and potentially effective strategy to improve sun protection behaviors.
OBJECTIVE


This pilot randomized controlled clinical trial evaluated the feasibility and preliminary impact of Sun Safe Partners Online, an online, couple-focused intervention to improve sun protection behavior.
METHODS


Seventy five couples reporting suboptimal levels of sun protection recruited from Facebook advertisements were randomized to receive a web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention. Sun Safe Partners Online had four individual-focused modules and four couple-focused modules. Feasibility was assessed by study enrollment, engagement, follow-up survey completion, and intervention evaluation. Participants completed baseline and a one month post-intervention surveys assessing sun protection and sun exposure, along with individual and relationship attitudes about the importance of sun protection. Using Facebook as a recruitment strategy resulted in rapid enrollment and higher acceptance than for the prior telephone and print trial.
RESULTS


The follow-up survey completion was higher in the Generic Online condition (100%) than the Sun Safe Partners Online condition (87.2%). Engagement in Sun Safe Partners Online was high with more than two-thirds of participants completing all modules. Evaluations of Sun Safe Partners Online content and features as well as ease of navigation were excellent. Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
CONCLUSIONS


This study utilized a novel approach to facilitating engagement in sun protection by harnessing relationship influences among spouses and co-habiting partners. A couple-focused intervention may hold promise as a way to improve sun protection behaviors beyond interventions focused solely on individuals by leveraging the concern, collaboration, and support among intimate partners and addressing relationship-based barriers to sun protection.
CLINICALTRIAL


",2020,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","['Sun Safe Partners Online', 'spouses and co-habiting partners', 'Seventy five couples reporting suboptimal levels of sun protection recruited from Facebook advertisements']","['web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention', 'Sun Safe Partners Online, an online, couple-focused intervention']",[],"[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",[],75.0,0.170333,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Manne', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, CINJ195 Little Albany Street, New Brunswick, US.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., Golden, US.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Devine', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, CINJ195 Little Albany Street, New Brunswick, US.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Heckman', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, CINJ195 Little Albany Street, New Brunswick, US.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, US.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Frederick', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, CINJ195 Little Albany Street, New Brunswick, US.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mitarotondo', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, US.'}]",Journal of medical Internet research,['10.2196/18037']
3047,32673222,The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial.,"BACKGROUND


Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied.
OBJECTIVE


This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF).
METHODS


We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis.
RESULTS


A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; P=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; P=.005).
CONCLUSIONS


ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care.
TRIAL REGISTRATION


Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691.",2020,"A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention.","['Chronic Heart Failure', 'A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years']","['Innovative Telemonitoring Enhanced Care Program', 'ITEC-CHF', 'Telemonitoring']",['withdrawal rate'],"[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",184.0,0.0472483,"A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'RECOVER Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Jayasena', 'Affiliation': 'The Australian e-Health Research Centre, Commonwealth Scientific & Industrial Research Organisation Health & Biosecurity, Melbourne, Australia.'}, {'ForeName': 'Sheau Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Australia Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Dowling', 'Affiliation': 'Department of Community Health, Peninsula Health, Melbourne, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Layland', 'Affiliation': 'Department of Cardiology, Peninsula Health, Melbourne, Australia.'}, {'ForeName': 'Norm', 'Initials': 'N', 'LastName': 'Good', 'Affiliation': 'RECOVER Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Mohanraj', 'Initials': 'M', 'LastName': 'Karunanithi', 'Affiliation': 'RECOVER Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Edwards', 'Affiliation': 'Department of Community Health, Peninsula Health, Melbourne, Australia.'}]",Journal of medical Internet research,['10.2196/17559']
3048,32673226,Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial.,"BACKGROUND


Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT.
OBJECTIVE


This study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings.
METHODS


A 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a 3-month follow-up.
RESULTS


The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up. Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants.
CONCLUSIONS


EmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish public mental health system. The implications of this RCT, limitations, and suggestions for future research are discussed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668.",2020,"The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up.","['214 participants', 'specialized mental health care', 'Emotional Disorders Versus Treatment as Usual in Specialized Care', 'patients from public specialized mental health care settings']","['Transdiagnostic Guided Internet-Delivered Protocol', 'transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance', 'EmotionRegulation', 'TAU', 'EmotionRegulation with treatment as usual (TAU', 'cognitive behavioral therapy (CBT']","['superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life', 'effectiveness and acceptability']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",214.0,0.109225,"The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'González-Robles', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Díaz-García', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Roca', 'Affiliation': 'Department of Personality, Assessment, and Clinical Psychology, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Josep Antoni', 'Initials': 'JA', 'LastName': 'Ramos-Quiroga', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}]",Journal of medical Internet research,['10.2196/18220']
3049,32673228,Evaluating the Impact of the Grading and Assessment of Predictive Tools Framework on Clinicians and Health Care Professionals' Decisions in Selecting Clinical Predictive Tools: Randomized Controlled Trial.,"BACKGROUND


While selecting predictive tools for implementation in clinical practice or for recommendation in clinical guidelines, clinicians and health care professionals are challenged with an overwhelming number of tools. Many of these tools have never been implemented or evaluated for comparative effectiveness. To overcome this challenge, the authors developed and validated an evidence-based framework for grading and assessment of predictive tools (the GRASP framework). This framework was based on the critical appraisal of the published evidence on such tools.
OBJECTIVE


The aim of the study was to examine the impact of using the GRASP framework on clinicians' and health care professionals' decisions in selecting clinical predictive tools.
METHODS


A controlled experiment was conducted through a web-based survey. Participants were randomized to either review the derivation publications, such as studies describing the development of the predictive tools, on common traumatic brain injury predictive tools (control group) or to review an evidence-based summary, where each tool had been graded and assessed using the GRASP framework (intervention group). Participants in both groups were asked to select the best tool based on the greatest validation or implementation. A wide group of international clinicians and health care professionals were invited to participate in the survey. Task completion time, rate of correct decisions, rate of objective versus subjective decisions, and level of decisional conflict were measured.
RESULTS


We received a total of 194 valid responses. In comparison with not using GRASP, using the framework significantly increased correct decisions by 64%, from 53.7% to 88.1% (88.1/53.7=1.64; t 193 =8.53; P<.001); increased objective decision making by 32%, from 62% (3.11/5) to 82% (4.10/5; t 189 =9.24; P<.001); decreased subjective decision making based on guessing by 20%, from 49% (2.48/5) to 39% (1.98/5; t 188 =-5.47; P<.001); and decreased prior knowledge or experience by 8%, from 71% (3.55/5) to 65% (3.27/5; t 187 =-2.99; P=.003). Using GRASP significantly decreased decisional conflict and increased the confidence and satisfaction of participants with their decisions by 11%, from 71% (3.55/5) to 79% (3.96/5; t 188 =4.27; P<.001), and by 13%, from 70% (3.54/5) to 79% (3.99/5; t 188 =4.89; P<.001), respectively. Using GRASP decreased the task completion time, on the 90th percentile, by 52%, from 12.4 to 6.4 min (t 193 =-0.87; P=.38). The average System Usability Scale of the GRASP framework was very good: 72.5% and 88% (108/122) of the participants found the GRASP useful.
CONCLUSIONS


Using GRASP has positively supported and significantly improved evidence-based decision making. It has increased the accuracy and efficiency of selecting predictive tools. GRASP is not meant to be prescriptive; it represents a high-level approach and an effective, evidence-based, and comprehensive yet simple and feasible method to evaluate, compare, and select clinical predictive tools.",2020,"In comparison with not using GRASP, using the framework significantly increased correct decisions by 64%, from 53.7% to 88.1% (88.1/53.7=1.64; t 193 =8.53; P<.001); increased objective decision making by 32%, from 62% (3.11/5) to 82% (4.10/5; t 189 =9.24; P<.001); decreased subjective decision making based on guessing by 20%, from 49% (2.48/5) to 39% (1.98/5; t 188 =-5.47; P<.001); and decreased prior knowledge or experience by 8%, from 71% (3.55/5) to 65% (3.27/5; t 187 =-2.99; P=.003).",[],['GRASP framework'],"['Task completion time, rate of correct decisions, rate of objective versus subjective decisions, and level of decisional conflict', 'correct decisions', 'task completion time', 'prior knowledge or experience', 'objective decision making', 'average System Usability Scale of the GRASP framework', 'decisional conflict', 'confidence and satisfaction']",[],"[{'cui': 'C0220843', 'cui_str': 'Grasp'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",194.0,0.087758,"In comparison with not using GRASP, using the framework significantly increased correct decisions by 64%, from 53.7% to 88.1% (88.1/53.7=1.64; t 193 =8.53; P<.001); increased objective decision making by 32%, from 62% (3.11/5) to 82% (4.10/5; t 189 =9.24; P<.001); decreased subjective decision making based on guessing by 20%, from 49% (2.48/5) to 39% (1.98/5; t 188 =-5.47; P<.001); and decreased prior knowledge or experience by 8%, from 71% (3.55/5) to 65% (3.27/5; t 187 =-2.99; P=.003).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khalifa', 'Affiliation': 'Centre for Health Informatics, Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Magrabi', 'Affiliation': 'Centre for Health Informatics, Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Gallego Luxan', 'Affiliation': 'Centre for Big Data Research in Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}]",Journal of medical Internet research,['10.2196/15770']
3050,32679602,A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial.,"BACKGROUND


Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups.
METHODS


This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing.
RESULTS


There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %,  P  < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls ( P  = 0.02).
CONCLUSIONS


This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.",2020,"There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %,  P  < 0.001).","['hemostasis during endoscopic submucosal dissection', '101 patients undergoing ESD']","['control group where diathermy', 'Endoscopic submucosal dissection (ESD']","['Complete wound healing', 'procedure length, time for hemostasis, and delayed bleeding rate', 'intraprocedural hemostasis', 'procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups']","[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",101.0,0.0500361,"There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %,  P  < 0.001).","[{'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Kesavan', 'Initials': 'K', 'LastName': 'Kandiah', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Chedgy', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Fogg', 'Affiliation': 'Department of Research and Innovation, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Sreedhari', 'Initials': 'S', 'LastName': 'Thayalasekaran', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Baker-Moffatt', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Dash', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lyons-Amos', 'Affiliation': 'Department of Research and Innovation, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Gaius', 'Initials': 'G', 'LastName': 'Longcroft-Wheaton', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bhandari', 'Affiliation': 'Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}]",Endoscopy,['10.1055/a-1198-0558']
3051,32679728,Effects of 120 vs. 60 and 90 g/h Carbohydrate Intake during a Trail Marathon on Neuromuscular Function and High Intensity Run Capacity Recovery.,"BACKGROUND


Current carbohydrate (CHO) intake recommendations for ultra-trail activities lasting more than 2.5 h is 90 g/h. However, the benefits of ingesting 120 g/h during a mountain marathon in terms of post-exercise muscle damage have been recently demonstrated. Therefore, the aim of this study was to analyze and compare the effects of 120 g/h CHO intake with the recommendations (90 g/h) and the usual intake for ultra-endurance athletes (60 g/h) during a mountain marathon on internal exercise load, and post-exercise neuromuscular function and recovery of high intensity run capacity.
METHODS


Twenty-six elite trail-runners were randomly distributed into three groups: LOW (60 g/h), MED (90 g/h) and HIGH (120 g/h), according to CHO intake during a 4000-m cumulative slope mountain marathon. Runners were measured using the Abalakov Jump test, a maximum a half-squat test and an aerobic power-capacity test at baseline (T1) and 24 h after completing the race (T2).
RESULTS


Changes in Abalakov jump time (ABK JT ), Abalakov jump height (ABK H ), half-squat test 1 repetition maximum (HST 1RM ) between T1 and T2 showed significant differences by Wilcoxon signed rank test only in LOW and MED ( p  < 0.05), but not in the HIGH group ( p  > 0.05). Internal load was significantly lower in the HIGH group ( p  = 0.017) regarding LOW and MED by Mann Whitney  u  test. A significantly lower change during the study in ABK JT  ( p  = 0.038), ABK H  ( p  = 0.038) HST 1RM  ( p  = 0.041) and in terms of fatigue ( p  = 0.018) and lactate ( p  = 0.012) within the aerobic power-capacity test was presented in HIGH relative to LOW and MED.
CONCLUSIONS


120 g/h CHO intake during a mountain marathon might limit neuromuscular fatigue and improve recovery of high intensity run capacity 24 h after a physiologically challenging event when compared to 90 g/h and 60 g/h.",2020,Internal load was significantly lower in the HIGH group ( p  = 0.017) regarding LOW and MED by Mann Whitney  u  test.,['Twenty-six elite trail-runners'],[],"['Abalakov jump time (ABK JT ', 'fatigue', 'Abalakov jump height (ABK H ), half-squat test 1 repetition maximum (HST 1RM ', 'Wilcoxon signed rank test only in LOW and MED', 'ABK H  ', 'Internal load', 'Neuromuscular Function and High Intensity Run Capacity Recovery']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}]",[],"[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.0286564,Internal load was significantly lower in the HIGH group ( p  = 0.017) regarding LOW and MED by Mann Whitney  u  test.,"[{'ForeName': 'Aritz', 'Initials': 'A', 'LastName': 'Urdampilleta', 'Affiliation': 'Centro Investigación y Formación ElikaSport, Cerdanyola del Valles, 08290 Barcelona, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Arribalzaga', 'Affiliation': 'Institute of Biomedicine (IBIOMED), Physiotherapy Department, University of Leon, Campus de Vegazana, 24071 Leon, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Viribay', 'Affiliation': 'Glut4Science, Physiology, Nutrition and Sport, 01004 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Castañeda-Babarro', 'Affiliation': 'Health, Physical Activity and Sports Science Laboratory, Department of Physical Activity and Sports, Faculty of Psychology and Education, University of Deusto, 48007 Bizkaia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Seco-Calvo', 'Affiliation': 'Institute of Biomedicine (IBIOMED), Physiotherapy Department, University of Leon, Researcher at the Basque Country University, Campus de Vegazana, 24071 Leon, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}]",Nutrients,['10.3390/nu12072094']
3052,32673060,Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial.,"BACKGROUND


No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).
OBJECTIVE


To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.
DESIGN


Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).
SETTING


Internet-based trial across the United States and Canada (40 states and 3 provinces).
PARTICIPANTS


Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.
INTERVENTION


Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo.  Measures : Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.
RESULTS


Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 points [95% CI, -0.61 to 0.07 points];  P  = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo ( P  = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo ( P  < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
LIMITATIONS


Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.
CONCLUSION


Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.
PRIMARY FUNDING SOURCE


Private donors.",2020,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","['outpatients with early, mild COVID-19', 'Nonhospitalized Adults', '22 March through 20 May 2020', '341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting', 'Internet-based trial across the United States and Canada', 'Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset', 'adult outpatients', '491 patients randomly assigned to a group, 423 contributed primary end point data']","['hydroxychloroquine', 'Hydroxychloroquine', 'Early COVID-19', 'Oral hydroxychloroquine', 'placebo']","['ongoing symptoms', 'overall symptom severity', '10-point visual analogue scale', 'Medication adverse effects', 'symptom severity', 'hospitalized death', 'Change in symptom severity', 'COVID-19 severity']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",423.0,0.761778,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","[{'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Darlette', 'Initials': 'D', 'LastName': 'Luke', 'Affiliation': 'M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (I.S.S.).'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}]",Annals of internal medicine,['10.7326/M20-4207']
3053,32673065,Effect of counselling with men on perceived stress and social support of their pregnant wives.,"BACKGROUND


Given the important role of spouses during pregnancy, this study aimed to determine the effect of counseling with men on stress and social support of their women (primary outcomes), anxiety, depression, weight gain, newborns' anthropometric indicators, frequency of cesarean section and preterm delivery (secondary outcomes).
METHODS


102 pregnant women were randomly assigned to two groups of counseling and control. Four sessions of counseling were held for the spouses of intervention group. Perceived Personal Resource Questionnaire-85-Part2, Perceived Stress Scale, Edinburgh's Postpartum Depression Scale, and Spielberger's State and Trait Anxiety Inventory were completed before and four weeks after intervention. The participants were followed up until delivery, and newborns' anthropometric indicators, delivery type, and preterm delivery were recorded.
RESULTS


The mean score of social support increased significantly 4 weeks after intervention in the counseling group compared to the control group (MD:12.7; 95%CI: 18.5 to 6.9). There was no significant difference between groups in the mean score of stress, anxiety, depression, and weight gain during pregnancy at four weeks after intervention and also frequency of cesarean delivery, preterm delivery, and anthropometric indicators of newborns ( p >0.05).
CONCLUSIONS


Counseling with fathers can be recommended as an effective intervention to increase social support of pregnant women.
TRIAL REGISTRATION


IRCT2017042910324N38. Registered 25 June 2017, http://en.irct.ir/trial/10813.",2020,"There was no significant difference between groups in the mean score of stress, anxiety, depression, and weight gain during pregnancy at four weeks after intervention and also frequency of cesarean delivery, preterm delivery, and anthropometric indicators of newborns ( p >0.05).
","['pregnant wives', '102 pregnant women', 'pregnant women']",[],"[""anxiety, depression, weight gain, newborns' anthropometric indicators, frequency of cesarean section and preterm delivery (secondary outcomes"", 'mean score of social support', ""Perceived Personal Resource Questionnaire-85-Part2, Perceived Stress Scale, Edinburgh's Postpartum Depression Scale, and Spielberger's State and Trait Anxiety Inventory"", 'mean score of stress, anxiety, depression, and weight gain during pregnancy', 'frequency of cesarean delivery, preterm delivery, and anthropometric indicators of newborns']","[{'cui': 'C0580085', 'cui_str': 'Wife pregnant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",102.0,0.0724719,"There was no significant difference between groups in the mean score of stress, anxiety, depression, and weight gain during pregnancy at four weeks after intervention and also frequency of cesarean delivery, preterm delivery, and anthropometric indicators of newborns ( p >0.05).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mohammadpour', 'Affiliation': 'Midwifery Department, Tabriz University of Medical Sciences , Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh Charandabi', 'Affiliation': 'Midwifery Department, Tabriz University of Medical Sciences , Tabriz, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Malakouti', 'Affiliation': 'Midwifery Department, Tabriz University of Medical Sciences , Tabriz, Iran.'}, {'ForeName': 'Mehriar', 'Initials': 'M', 'LastName': 'Nadar Mohammadi', 'Affiliation': 'Faculty of Medicine, Ardabil University of Medical Sciences , Ardabil, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Center, Tabriz University of Medical Sciences , Tabriz, Iran.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2020.1792428']
3054,32673082,Massage Compared with Massage Plus Acupuncture for Breast Cancer Patients Undergoing Reconstructive Surgery.,"Objectives:  Integrative therapies have been incorporated increasingly into health and wellness in the United States in recent decades. Their potential benefits are under evaluation in various situations, including pain and symptom relief for cancer patients and survivors. This pilot study evaluated whether combining two integrative complementary approaches augments a patient's benefit by reducing postoperative stress, pain, anxiety, muscle tension, and fatigue compared with one integrative complementary approach alone.  Design:  Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative complementary alternative therapies for three consecutive days. All participants were observed for up to 3 months.  Subjects:  Forty-two participants were recruited from January 29, 2016 to July 11, 2018.  Interventions:  Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture.  Outcome measures:  Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.  Results:  Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment ( p  = 0.03 and  p  = 0.04). After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes ( p  = 0.49).  Conclusion:  No additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.",2020,"No additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood.","['Patients undergoing autologous tissue breast reconstruction', 'cancer patients and survivors', 'Interventions:  Twenty-one participants', 'Subjects:  Forty-two participants were recruited from January 29, 2016 to July 11, 2018', 'Breast Cancer Patients Undergoing Reconstructive Surgery']","['Combined massage and acupuncture', 'acupuncture', 'massage alone and 21 to massage and acupuncture', 'Massage+Acupuncture', 'Massage', 'Massage Plus Acupuncture']","['Patient satisfaction', 'pain, anxiety, relaxation, nausea, fatigue, and mood', 'Change in stress score', 'Outcome measures:  Stress, anxiety, relaxation, nausea, fatigue, pain, and mood', 'pain and symptom relief', 'Stress', 'fatigue, anxiety, relaxation, nausea, pain, and mood scores', 'postoperative stress, pain, anxiety, muscle tension, and fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}]",42.0,0.0842268,"No additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood.","[{'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Dilaveri', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Molly J', 'Initials': 'MJ', 'LastName': 'Mallory', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Liza J', 'Initials': 'LJ', 'LastName': 'Dion', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Fischer', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jorys', 'Initials': 'J', 'LastName': 'Martinez-Jorge', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Minh-Doan T', 'Initials': 'MT', 'LastName': 'Nguyen', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Shawn C', 'Initials': 'SC', 'LastName': 'Fokken', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Bauer', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Dietlind L', 'Initials': 'DL', 'LastName': 'Wahner-Roedler', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0479']
3055,32673102,Effects of the Interactive Videogame Nintendo Wii Sports on Upper Limb Motor Function of Individuals with Post-polio Syndrome: Randomized Clinical Trial.,"Objective:  To compare the effects of an upper limb videogame-based training with a training based on similar motor demands on upper limb function, dexterity, functionality, balance, fatigue, and pain in post-polio syndrome (PPS) and to assess the acceptability, feasibility, and safety of the intervention.  Materials and Methods:  This is a randomized, parallel, single-blind clinical trial. Thirty-nine individuals were randomized into Interactive Videogames Group (IVG,  n  = 19) and Active Exercises Group (AEG,  n  = 20). Participants performed two weekly sessions (50 minutes each), totaling 14 sessions with the aim of providing mild to moderate intensity. IVG practiced four Nintendo Wii Sport games (tennis, golf, boxing, and bowling). The AEG performed similar movements required for IVG. Primary outcome: upper limb motor function-Motor Function Measure-32. Secondary outcomes: dexterity-Box and Block test; functionality-Functional Independence Measure; balance-Functional Reach Test, muscle fatigue-Fatigue Severity Scale, upper limb pain-Visual Analogue Scale for pain, acceptability, applicability, and safety. Analysis of group, time, interaction between groups, and time effects was performed through repeated-measures analysis of variance (2 × 3) and Bonferroni post hoc test with alpha of 0.05.  Results:  Interactive videogames were safe, feasible, and acceptable. Both groups showed similar postintervention improvement on motor function, functionality, balance, pain, and fatigue, with maintenance over the follow-up period. There was an interaction effect between the groups on dexterity and the IVG demonstrated better performance compared with the AEG.  Final Considerations:  The similar positive clinical effects of the interactive video games on PPS upper limb function and its superior effects on dexterity support its use as a safe and feasible intervention. Particularly when it comes to chronic patients, who require long-term physical therapy, new and stimulating interventions may contribute to the rehabilitation process and improve their engagement in the treatment. Registered on the Brazilian Clinical Trials platform under number RBR-8S2NBF.",2020,There was an interaction effect between the groups on dexterity and the IVG demonstrated better performance compared with the AEG.  Final Considerations:  The similar positive clinical effects of the interactive video games on PPS upper limb function and its superior effects on dexterity support its use as a safe and feasible intervention.,"['Individuals with Post-polio Syndrome', 'Thirty-nine individuals']","['Interactive Videogames Group (IVG,  n \u2009=\u200919) and Active Exercises Group (AEG,  n \u2009=\u200920', 'Interactive Videogame Nintendo Wii Sports', 'upper limb videogame-based training with a training based on similar motor demands']","['dexterity-Box and Block test; functionality-Functional Independence Measure; balance-Functional Reach Test, muscle fatigue-Fatigue Severity Scale, upper limb pain-Visual Analogue Scale for pain, acceptability, applicability, and safety', 'acceptability, feasibility, and safety', 'upper limb motor function-Motor Function Measure-32', 'Upper Limb Motor Function', 'motor function, functionality, balance, pain, and fatigue, with maintenance', 'upper limb function, dexterity, functionality, balance, fatigue, and pain in post-polio syndrome (PPS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0080040', 'cui_str': 'Post poliomyelitis syndrome'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080040', 'cui_str': 'Post poliomyelitis syndrome'}, {'cui': 'C0265259', 'cui_str': 'Popliteal pterygium syndrome'}]",39.0,0.0432868,There was an interaction effect between the groups on dexterity and the IVG demonstrated better performance compared with the AEG.  Final Considerations:  The similar positive clinical effects of the interactive video games on PPS upper limb function and its superior effects on dexterity support its use as a safe and feasible intervention.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Christina Gouveia E Silva', 'Affiliation': 'Neuroscience and Behaviour post graduation program of the Institute of Psicology of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lange', 'Affiliation': 'College of Nursing & Health Sciences, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Jéssica Maria Ribeiro', 'Initials': 'JMR', 'LastName': 'Bacha', 'Affiliation': 'Rehabilitation Science Post Graduation Program of the Department of Physical Therapy, Speech and Occupational Therapy of the School of Medicine of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'José Eduardo', 'Initials': 'JE', 'LastName': 'Pompeu', 'Affiliation': 'Department of Physical Therapy, Speech and Occupational Therapy of the School of Medicine of the University of Sao Paulo, Sao Paulo, Brazil.'}]",Games for health journal,['10.1089/g4h.2019.0192']
3056,32673233,Efficacy of a Guided Web-Based Self-Management Intervention for Depression or Dysthymia: Randomized Controlled Trial With a 12-Month Follow-Up Using an Active Control Condition.,"BACKGROUND


An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention's efficacy. Studies using active controls are rare and have not yielded conclusive results.
OBJECTIVE


The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition.
METHODS


A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology-self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses.
RESULTS


Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95% CI -0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t 259 =5.804; P<.01).
CONCLUSIONS


The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy.
TRIAL REGISTRATION


International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323.",2020,"Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group.","['patients with depression', '348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview', 'patients with depression compared with web-based progressive muscle relaxation as an active control condition', 'Depression or Dysthymia']","['Guided Web-Based Self-Management Intervention', 'cognitive behavioral therapy (iFightDepression tool']","['Acute antidepressant effects', 'symptoms of depression', 'life quality', 'quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",348.0,0.133249,"Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Oehler', 'Affiliation': 'German Depression Foundation, Leipzig, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Görges', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Rogalla', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rummel-Kluge', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität Frankfurt, Frankfurt, Germany.'}]",Journal of medical Internet research,['10.2196/15361']
3057,32673246,A Physical Activity and Diet Program Delivered by Artificially Intelligent Virtual Health Coach: Proof-of-Concept Study.,"BACKGROUND


Poor diet and physical inactivity are leading modifiable causes of death and disease. Advances in artificial intelligence technology present tantalizing opportunities for creating virtual health coaches capable of providing personalized support at scale.
OBJECTIVE


This proof of concept study aimed to test the feasibility (recruitment and retention) and preliminary efficacy of physical activity and Mediterranean-style dietary intervention (MedLiPal) delivered via artificially intelligent virtual health coach.
METHODS


This 12-week single-arm pre-post study took place in Adelaide, Australia, from March to August 2019. Participants were inactive community-dwelling adults aged 45 to 75 years, recruited through news stories, social media posts, and flyers. The program included access to an artificially intelligent chatbot, Paola, who guided participants through a computer-based individualized introductory session, weekly check-ins, and goal setting, and was available 24/7 to answer questions. Participants used a Garmin Vivofit4 tracker to monitor daily steps, a website with educational materials and recipes, and a printed diet and activity log sheet. Primary outcomes included feasibility (based on recruitment and retention) and preliminary efficacy for changing physical activity and diet. Secondary outcomes were body composition (based on height, weight, and waist circumference) and blood pressure.
RESULTS


Over 4 weeks, 99 potential participants registered expressions of interest, with 81 of those screened meeting eligibility criteria. Participants completed a mean of 109.8 (95% CI 1.9-217.7) more minutes of physical activity at week 12 compared with baseline. Mediterranean diet scores increased from a mean of 3.8 out of 14 at baseline, to 9.6 at 12 weeks (mean improvement 5.7 points, 95% CI 4.2-7.3). After 12 weeks, participants lost an average 1.3 kg (95% CI -0.1 to -2.5 kg) and 2.1 cm from their waist circumference (95% CI -3.5 to -0.7 cm). There were no significant changes in blood pressure. Feasibility was excellent in terms of recruitment, retention (90% at 12 weeks), and safety (no adverse events).
CONCLUSIONS


An artificially intelligent virtual assistant-led lifestyle-modification intervention was feasible and achieved measurable improvements in physical activity, diet, and body composition at 12 weeks. Future research examining artificially intelligent interventions at scale, and for other health purposes, is warranted.",2020,"An artificially intelligent virtual assistant-led lifestyle-modification intervention was feasible and achieved measurable improvements in physical activity, diet, and body composition at 12 weeks.","['Participants were inactive community-dwelling adults aged 45 to 75 years, recruited through news stories, social media posts, and flyers']","['Garmin Vivofit4 tracker', 'artificially intelligent chatbot, Paola, who guided participants through a computer-based individualized introductory session', 'physical activity and Mediterranean-style dietary intervention (MedLiPal']","['feasibility (based on recruitment and retention) and preliminary efficacy for changing physical activity and diet', 'blood pressure', 'body composition (based on height, weight, and waist circumference) and blood pressure', 'Mediterranean diet scores', 'waist circumference', 'physical activity, diet, and body composition', 'minutes of physical activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0648343,"An artificially intelligent virtual assistant-led lifestyle-modification intervention was feasible and achieved measurable improvements in physical activity, diet, and body composition at 12 weeks.","[{'ForeName': 'Carol Ann', 'Initials': 'CA', 'LastName': 'Maher', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Courtney Rose', 'Initials': 'CR', 'LastName': 'Davis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Rachel Grace', 'Initials': 'RG', 'LastName': 'Curtis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Camille Elizabeth', 'Initials': 'CE', 'LastName': 'Short', 'Affiliation': 'Melbourne Centre for Behaviour Change, School of Psychological Sciences and School of Health Sciences, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Karen Joy', 'Initials': 'KJ', 'LastName': 'Murphy', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Clinical and Health Sciences, University of South Australia, Adelaide, Australia.'}]",JMIR mHealth and uHealth,['10.2196/17558']
3058,32673255,Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.,"BACKGROUND


The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness.
OBJECTIVE


This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone.
METHODS


The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients.
RESULTS


The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020.
CONCLUSIONS


iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17160.",2020,The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates.,"['patients who wish to quit smoking, compared with usual care alone', '1671 participants were recruited between August 2016 and July 2019', 'Primary Care (iQuit in Practice II', 'Participants were recruited through primary care clinics and talked to a smoking cessation advisor']","['tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients', 'Tailored Web- and Text-Based Smoking Cessation Support', 'usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention']","['self-reported prolonged abstinence biochemically verified using saliva cotinine', 'validated quit rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",1671.0,0.0975898,The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates.,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Proctor', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Sloan', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brimicombe', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Coleman', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'University of Cambridge, Cambridge, United Kingdom.'}]",JMIR research protocols,['10.2196/17160']
3059,32673257,"A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial.","BACKGROUND


Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice.
OBJECTIVE


This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management.
METHODS


The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only).
RESULTS


Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021.
CONCLUSIONS


myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia.
TRIAL REGISTRATION


Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15994.",2020,"A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice.
","['Patients with ulcerative colitis (UC', 'UC patients', 'With Ulcerative Colitis', 'Patients']","['novel Web-based decision aid (DA', 'CRCT', 'A Web-Based Decision Aid (myAID', 'myAID (intervention) against usual care without access to myAID (control']","['health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity', 'Quality of Life, Empowerment, Decision Making, and Disease Control', 'quality of decision making and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0521124', 'cui_str': 'Against'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.135812,"A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice.
","[{'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Kim', 'Affiliation': 'Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Afaf', 'Initials': 'A', 'LastName': 'Girgis', 'Affiliation': 'Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Karimi', 'Affiliation': 'Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Sechi', 'Affiliation': 'Department of Gastroenterology, Liverpool Hospital, Sydney, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Descallar', 'Affiliation': 'Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Andrews', 'Affiliation': 'IBD Service, Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Siegel', 'Affiliation': 'Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Connor', 'Affiliation': 'Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Sydney, Australia.'}]",JMIR research protocols,['10.2196/15994']
3060,32673496,The Arousal Threshold as a Drug-Target to Improve CPAP Adherence: Secondary Analysis of a Randomized Trial.,,2020,,[],[],['CPAP Adherence'],[],[],"[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.20808,,"[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Schmickl', 'Affiliation': 'University of California San Diego, 8784, Division of Pulmonary, Critical Care and Sleep Medicine, La Jolla, California, United States; cschmickl@health.ucsd.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lettieri', 'Affiliation': 'Uniformed Services University of the Health Sciences, 1685, Pulmonary, Critical Care and Sleep Medicine, Bethesda, Maryland, United States.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'University of California San Diego, 8784, Division of Pulmonary, Critical Care and Sleep Medicine, La Jolla, California, United States.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeYoung', 'Affiliation': 'University of California San Diego, 8784, Division of Pulmonary, Critical Care and Sleep Medicine, La Jolla, California, United States.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Monash University, 2541, Sleep and Circadian Medicine Laboratory, Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Clayton, Victoria, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'University of California San Diego, 8784, Division of Pulmonary, Critical Care and Sleep Medicine, La Jolla, California, United States.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'University of California San Diego, 8784, Division of Pulmonary, Critical Care and Sleep Medicine, La Jolla, California, United States.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202003-0502LE']
3061,32673497,Dapagliflozin and Diuretic Use in Patients with Heart Failure and Reduced Ejection Fraction in DAPA-HF.,"Background:  In the DAPA-HF trial, the SGLT2 inhibitor dapagliflozin reduced the risk of worsening heart failure and death in patients with heart failure and reduced ejection fraction. We examined efficacy and tolerability of dapagliflozin in relation to background diuretic treatment and change in diuretic therapy following randomization to dapagliflozin or placebo.  Methods:  We examined the effects of study treatment in the following subgroups: no diuretic, diuretic dose equivalent to furosemide <40mg daily, 40mg daily and >40mg daily at baseline. We examined the primary composite endpoint of cardiovascular (CV) death or a worsening HF event, its components, all-cause death and symptoms.  Results:  Of 4616 analyzable patients, 736 (15.9%) were on no diuretic, 1311 (28.4%) were on <40mg, 1365 (29.6%) on 40 mg and 1204 (26.1%) of patients were taking >40 mg. Compared with placebo, dapagliflozin reduced the risk of the primary endpoint across each of these subgroups: hazard ratio [HR]: 0.57 (95% CI 0.36-0.92), 0.83 (0.63-1.10), 0.77 (0.60-0.99) and 0.78 (0.63-0.97), respectively (P-interaction 0.61). The HR in patients taking any diuretic was 0.78 (0.68-0.90). Improvement in symptoms and treatment toleration was consistent across the diuretic subgroups. Diuretic dose did not change in most patients during follow-up and mean diuretic dose did not differ between the dapagliflozin and placebo group after randomization.  Conclusions:  The efficacy and safety of dapagliflozin was consistent across the diuretic subgroups examined in DAPA-HF.  Clinical Trial Registration:  DAPA-HF: ClinicalTrials.gov Identifier NCT03036124.",2020,Diuretic dose did not change in most patients during follow-up and mean diuretic dose did not differ between the dapagliflozin and placebo group after randomization.  ,"['Patients with Heart Failure and Reduced Ejection Fraction in DAPA-HF', '4616 analyzable patients, 736 (15.9%) were on no diuretic, 1311 (28.4%) were on <40mg, 1365 (29.6%) on 40 mg and 1204 (26.1%) of patients were taking >40 mg', 'patients with heart failure and reduced ejection fraction']","['dapagliflozin or placebo', 'dapagliflozin', 'DAPA-HF', 'SGLT2 inhibitor dapagliflozin', 'Dapagliflozin and Diuretic', 'diuretic, diuretic dose equivalent to furosemide <40mg daily, 40mg daily and >40mg daily at baseline', 'placebo, dapagliflozin', 'dapagliflozin and placebo']","['cardiovascular (CV) death or a worsening HF event, its components, all-cause death and symptoms', 'Improvement in symptoms and treatment toleration', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",4616.0,0.120661,Diuretic dose did not change in most patients during follow-up and mean diuretic dose did not differ between the dapagliflozin and placebo group after randomization.  ,"[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Jackson', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital and 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg-Saar, Germany.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Quantitative Clinical Pharmacology, IMED Biotech Unit, AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Medanta, Gurgaon, India.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Demets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': '5th Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Cardiovascular, Renal and Metabolism Translational Medicines Unit, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Cumming School of Medicine and Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City, MO.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047077']
3062,32673517,Splanchnic Venous Compression Enhances the Effects of ß-Blockade in the Treatment of Postural Tachycardia Syndrome.,"Background Splanchnic venous pooling induced by upright posture triggers a compensatory increase in heart rate (HR), a response that is exaggerated in patients with postural tachycardia syndrome. To assess whether abdominal compression attenuates orthostatic tachycardia and improves symptoms, 18 postural tachycardia syndrome patients (32±2 years) were randomized to receive either abdominal compression (40 mm Hg applied with an inflatable binder ≈2 minutes before standing) or propranolol (20 mg) in a placebo-controlled, crossover study. Methods and Results Systolic blood pressure, HR, and symptoms were assessed while seated and standing, before and 2 hours postdrug. As expected, propranolol decreased standing HR compared with placebo (81±2 versus 98±4 beats per minute;  P <0.001) and was associated with lower standing systolic blood pressure (93±2 versus 100±2 mm Hg for placebo;  P =0.002). Compression had no effect on standing HR (96±4 beats per minute) but increased standing systolic blood pressure compared with placebo and propranolol (106±2 mm Hg;  P <0.01). Neither propranolol nor compression improved symptoms compared with placebo. In 16 patients we compared the combination of abdominal compression and propranolol with propranolol alone. The combination had no additional effect on standing HR (81±2 beats per minute for both interventions) but prevented the decrease in standing systolic blood pressure produced by propranolol (98±2 versus 93±2 mm Hg for propranolol;  P =0.029), and significantly improved total symptom burden (-6±2 versus -1±2 for propranolol;  P =0.041). Conclusions Splanchnic venous compression alone did not improve HR or symptoms but prevented the blood pressure decrease produced by propranolol. The combination was more effective in improving symptoms than either alone. Splanchnic venous compression can be a useful adjuvant therapy to propranolol in postural tachycardia syndrome. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00262470.",2020,"As expected, propranolol decreased standing HR compared with placebo (81±2 versus 98±4 beats per minute;  P <0.001) and was associated with lower standing systolic blood pressure (93±2 versus 100±2 mm ","['Postural Tachycardia Syndrome', '18 postural tachycardia syndrome patients (32±2\xa0years', 'patients with postural tachycardia syndrome']","['placebo and propranolol', 'Splanchnic venous compression', 'propranolol with propranolol alone', 'abdominal compression (40\xa0mm', 'abdominal compression attenuates orthostatic tachycardia', 'propranolol', 'placebo']","['HR or symptoms', 'total symptom burden', 'blood pressure', 'Systolic blood pressure, HR, and symptoms', 'standing systolic blood pressure', 'heart rate (HR', 'standing HR']","[{'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1303018', 'cui_str': 'Standing systolic blood pressure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",,0.169521,"As expected, propranolol decreased standing HR compared with placebo (81±2 versus 98±4 beats per minute;  P <0.001) and was associated with lower standing systolic blood pressure (93±2 versus 100±2 mm ","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Smith', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Satish R', 'Initials': 'SR', 'LastName': 'Raj', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Gamboa', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Cyndya A', 'Initials': 'CA', 'LastName': 'Shibao', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Bonnie K', 'Initials': 'BK', 'LastName': 'Black', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Peltier', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Sachin Y', 'Initials': 'SY', 'LastName': 'Paranjape', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Biaggioni', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Okamoto', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016196']
3063,31135084,Hepatitis B core-related antigen monitoring during peginterferon alfa treatment for HBeAg-negative chronic hepatitis B.,"Serum Hepatitis B core-related antigen (HBcrAg) level moderately correlates with cccDNA. We examined whether HBcrAg can add value in monitoring the effect of peginterferon (PEG-IFN) therapy for HBeAg-negative chronic hepatitis B (CHB) infection. Thus, serum HBcrAg level was measured in 133 HBeAg-negative, mainly Caucasian CHB patients, treated with 48 weeks of PEG-IFN alfa-2a. We assessed its association with response (ALT normalization & HBV DNA < 2000 IU/mL) at week 72. HBcrAg level strongly correlated with HBV DNA level (r = 0.8, P < 0.001) and weakly with qHBsAg and ALT (both r = 0.2, P = 0.01). At week 48, mean HBcrAg decline was -3.3 log U/mL. Baseline levels were comparable for patients with and without response at week 72 (5.0 vs 4.9 log U/mL, P = 0.59). HBcrAg decline at week 72 differed between patients with and without response (-2.4 vs -1.0 log U/mL, P = 0.001), but no cut-off could be determined. The pattern of decline in responders resembled that of HBV DNA, but HBcrAg decline was weaker (HBcrAg -2.5 log U/mL; HBV DNA: -4.0 log IU/mL, P < 0.001). For early identification of nonresponse, diagnostic accuracy of HBV DNA and qHBsAg decline at week 12 (AUC 0.742, CI-95% [0.0.629-0.855], P < 0.001) did not improve by adding HBcrAg decline (AUC 0.747, CI-95% [0.629-0.855] P < 0.001), nor by replacing HBV DNA decline by HBcrAg decline (AUC 0.754, CI-95% [0.641-0.867], P < 0.001). In conclusion, in Caucasian patients with HBeAg-negative CHB, decline of HBcrAg during PEG-IFN treatment was stronger in patients with treatment response. However, HBcrAg was not superior to HBV DNA and qHBsAg in predicting response during PEG-IFN treatment.",2019,"However, HBcrAg was not superior to HBV DNA and qHBsAg in predicting response during PEG-IFN treatment.","['HBeAg-negative chronic hepatitis B', 'HBeAg-negative chronic hepatitis B (CHB) infection', 'Caucasian patients with HBeAg-negative CHB', '\xa02000']","['peginterferon alfa treatment', 'peginterferon (PEG-IFN) therapy']","['response (ALT normalization & HBV DNA', 'HBV DNA and qHBsAg decline', 'HBV DNA level', 'U/mL. Baseline levels', 'serum HBcrAg level', 'Serum Hepatitis B core-related antigen (HBcrAg) level']","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0430420', 'cui_str': 'Antigen assay'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}]",,0.0901607,"However, HBcrAg was not superior to HBV DNA and qHBsAg in predicting response during PEG-IFN treatment.","[{'ForeName': 'Margo J H', 'Initials': 'MJH', 'LastName': 'van Campenhout', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rijckborst', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Willem Pieter', 'Initials': 'WP', 'LastName': 'Brouwer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gertine W', 'Initials': 'GW', 'LastName': 'van Oord', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferenci', 'Affiliation': 'Department of Internal Medicine, Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Fehmi', 'Initials': 'F', 'LastName': 'Tabak', 'Affiliation': 'Cerrahpasa Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Akdogan', 'Affiliation': 'Department of Gastroenterology, Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Binnur', 'Initials': 'B', 'LastName': 'Pinarbasi', 'Affiliation': 'Division of Gastroenterohepatology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Simon', 'Affiliation': 'Division of Infectious Diseases and Hepatology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'de Knegt', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Boonstra', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry L A', 'Initials': 'HLA', 'LastName': 'Janssen', 'Affiliation': 'Toronto Center for Liver Disease, Toronto Western and General Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Bettina E', 'Initials': 'BE', 'LastName': 'Hansen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}]",Journal of viral hepatitis,['10.1111/jvh.13117']
3064,31203233,Serum apolipoproteins and apolipoprotein-defined lipoprotein subclasses: a hypothesis-generating prospective study of cardiovascular events in T1D.,"APOB, APOC3, and APOE and apolipoprotein-defined lipoprotein subclasses (ADLSs; based on qualitative apolipoprotein complement) have been associated with dyslipidemia and CVD. Our main objective was to define associations of serum apolipoproteins and ADLSs with ""any CVD"" and ""major atherosclerotic cardiovascular events"" (MACEs) in a prospective study of T1D. Serum apolipoproteins and ADLSs (14 biomarkers in total) were measured in sera (obtained between 1997 and 2000) from a subset ( n  = 465) of the Epidemiology of Diabetes Interventions and Complications cohort. Prospective associations of ""any CVD"" (myocardial infarction, stroke, confirmed angina, silent myocardial infarction, revascularization, or congestive heart failure) and MACEs (fatal or nonfatal myocardial infarction or stroke), over 5,943 and 6,180 patient-years follow-up, respectively, were investigated using Cox proportional hazards models that were unadjusted and adjusted for risk factors. During 15 years of follow-up, 50 ""any CVD"" events and 24 MACEs occurred. Nominally significant positive univariate associations with ""any CVD"" were APOB, APOC3 and its subfractions [heparin precipitate, heparin-soluble (HS)], and ADLS-defined Lp-B. In adjusted analyses, APOC3-HS remained nominally significant. Nominally significant positive univariate associations with MACEs were APOC3 and its subfractions and Lp-B:C; those with total APOC3 and APOC3-HS persisted in adjusted analyses. However, these associations did not reach significance after adjusting for multiple testing. There were no significant associations of APOA1, APOA2, APOE, or other ADLSs with either ""any CVD"" or MACEs. These hypothesis-generating data suggest that total serum APOC3 and APOC3 in HDL are potentially important predictive biomarkers for any CVD and MACEs in adults with T1D.",2019,"Nominally significant positive univariate associations with ""any CVD"" were APOB, APOC3 and its subfractions [heparin precipitate, heparin-soluble (HS)], and ADLS-defined Lp-B.","['T1D. Serum apolipoproteins and ADLSs (14 biomarkers in total) were measured in sera (obtained between 1997 and 2000) from a subset ( n  = 465) of the Epidemiology of Diabetes Interventions and Complications cohort', 'adults with T1D']",[],"['any CVD"" (myocardial infarction, stroke, confirmed angina, silent myocardial infarction, revascularization, or congestive heart failure) and MACEs (fatal or nonfatal myocardial infarction or stroke', 'APOB, APOC3 and its subfractions [heparin precipitate, heparin-soluble (HS)], and ADLS-defined Lp-B', 'Serum apolipoproteins and apolipoprotein-defined lipoprotein subclasses', 'APOA1, APOA2, APOE, or other ADLSs with either ""any CVD"" or MACEs', 'APOB, APOC3, and APOE and apolipoprotein-defined lipoprotein subclasses (ADLSs']","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0340324', 'cui_str': 'Silent myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0855605', 'cui_str': 'Measurement of apolipoprotein A-II'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}]",,0.025063,"Nominally significant positive univariate associations with ""any CVD"" were APOB, APOC3 and its subfractions [heparin precipitate, heparin-soluble (HS)], and ADLS-defined Lp-B.","[{'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, Las Vegas, NV.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center Milken Institute School of Public Health, The George Washington University, Rockville, MD.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre University of Sydney, Camperdown, Sydney, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Stoner', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Klein', 'Affiliation': 'Division of Endocrinology Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Lopes-Virella', 'Affiliation': 'Division of Endocrinology Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham and the Birmingham Veterans Affairs Medical Center, Birmingham, AL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Division of Cardiology Los Angeles Biomedical Research Institute, Torrance, CA.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Alaupovic', 'Affiliation': 'Oklahoma Medical Research Foundation Oklahoma City, OK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Lyons', 'Affiliation': 'Division of Endocrinology Medical University of South Carolina, Charleston, SC lyonstj@musc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of lipid research,['10.1194/jlr.P090647']
3065,32680480,Efficacy and safety of ambrisentan in Chinese patients with connective tissue disease-pulmonary arterial hypertension: a post-hoc analysis.,"BACKGROUND


The efficacy and safety of ambrisentan has been previously evaluated in Chinese patients with pulmonary arterial hypertension (PAH). This post-hoc analysis assessed the efficacy and safety of ambrisentan in a subgroup of connective tissue disease (CTD) patients with PAH.
METHODS


In this open-label, single-arm study, patients received ambrisentan 5 mg once daily for 12 weeks, followed by 12-week dose titration period (dose up to 10 mg). Efficacy endpoints included change from baseline in exercise capacity (measured by 6-min walk test [6MWT]), N-terminal pro B type natriuretic peptide (NT-proBNP) plasma levels, WHO Functional Class (FC) and Borg Dyspnoea Index (BDI) scores from baseline to weeks 12 and 24. Safety endpoints included time to clinical worsening and incidence of adverse events (AEs).
RESULTS


In total, 71 Chinese patients with CTD-PAH were included in this analysis. Ambrisentan treatment significantly improved exercise capacity (6MWT) from baseline (mean: 366.4 m) to week 12 (63.8 m, p < 0.001) and week 24 (73.2 m, p < 0.001). A significant reduction in NT-proBNP levels was observed from baseline (mean: 1837.5 ng/L) to week 12 (- 1156.8 ng/L, p < 0.001) and week 24 (- 1095.5 ng/L, p < 0.001). BDI scores decreased significantly at week 12 (- 0.6, p < 0.001) and week 24 (- 0.4, p = 0.002) from baseline (mean: 2.7). The WHO FC improved in 29 (40.8%) and 34 (47.9%) patients at weeks 12 and 24, respectively. Adverse events were reported in 52 (73.2%) patients. One patient (1.4%) experienced clinical worsening at week 24.
CONCLUSION


Ambrisentan showed significant improvement in exercise capacity and no clinical worsening in the majority of Chinese patients with CTD-PAH in the 24-week treatment period. The AEs observed in the CTD-PAH subgroup were consistent with the known safety profile of ambrisentan in the overall Chinese PAH population.
TRIAL REGISTRATION


ClinicalTrial.gov Identifier, https://clinicaltrials.gov/, NCT01808313 Registration date (first time): February 28, 2013.",2020,"Ambrisentan treatment significantly improved exercise capacity (6MWT) from baseline (mean: 366.4 m) to week 12 (63.8 m, p < 0.001) and week 24 (73.2 m, p < 0.001).","['Chinese patients with pulmonary arterial hypertension (PAH', '71 Chinese patients with CTD-PAH', 'Chinese patients with connective tissue disease-pulmonary arterial hypertension', 'subgroup of connective tissue disease (CTD) patients with PAH']",['ambrisentan'],"['Adverse events', 'NT-proBNP levels', 'exercise capacity (measured by 6-min walk test [6MWT]), N-terminal pro B type natriuretic peptide (NT-proBNP) plasma levels, WHO Functional Class (FC) and Borg Dyspnoea Index (BDI) scores', 'exercise capacity', 'Efficacy and safety', 'efficacy and safety', 'exercise capacity (6MWT', 'time to clinical worsening and incidence of adverse events (AEs', 'BDI scores', 'WHO FC']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0009782', 'cui_str': 'Disorder of connective tissue'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",71.0,0.197107,"Ambrisentan treatment significantly improved exercise capacity (6MWT) from baseline (mean: 366.4 m) to week 12 (63.8 m, p < 0.001) and week 24 (73.2 m, p < 0.001).","[{'ForeName': 'Mengtao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science & Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.'}, {'ForeName': 'Zhi-Cheng', 'Initials': 'ZC', 'LastName': 'Jing', 'Affiliation': 'Key Lab of Pulmonary Vascular Medicine & FuWai Hospital, State Key lab of Cardiovascular disease, National center for Cardiovascular disease, Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': '2nd Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': '1st Affiliated Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Xiangya Hospital Central-South University, Changsha, Hunan, China.'}, {'ForeName': 'Gangcheng', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Wuhan Asia Heart Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': ""1st Affiliated Hospital of the Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jinming', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Qiushang', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': 'Qilu Hospital, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Bingxiang', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': '2nd Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'GlaxoSmithKline (China) R&D Company Limited, Shanghai, China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline (China) R&D Company Limited, Shanghai, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'GlaxoSmithKline (China) R&D Company Limited, Shanghai, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science & Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China. xiaofeng.zeng@cstar.org.cn.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01591-1']
3066,32680487,Patients' and clinicians' perspectives on a 'fast-track' pathway for patients with sciatica in primary care: qualitative findings from the SCOPiC stratified care trial.,"BACKGROUND


Sciatica is common and associated with significant impacts for the individual and society. The SCOPiC randomised controlled trial (RCT) (trial registration: ISRCTN75449581 ) tested stratified primary care for sciatica by subgrouping patients into one of three groups based on prognostic and clinical indicators. Patients in one group were 'fast-tracked' for a magnetic resonance imaging (MRI) scan and spinal specialist opinion. This paper reports qualitative research exploring patients' and clinicians' perspectives on the acceptability of this 'fast-track' pathway.
METHODS


Semi-structured interviews were conducted with 20 patients and 20 clinicians (general practitioners, spinal specialist physiotherapists, spinal surgeons). Data were analysed thematically and findings explored using Normalisation Process Theory (NPT) and 'boundary objects' concept.
RESULTS


Whilst the 'fast-track' pathway achieved a degree of 'coherence' (i.e. made sense) to both patients and clinicians, particularly in relation to providing early reassurance based on MRI scan findings, it was less 'meaningful' to some clinicians for managing patients with acute symptoms, reflecting a reluctance to move away from the usual 'stepped care' approach. Both groups felt a key limitation of the pathway was that it did not shorten patient waiting times between their spinal specialist consultation and further treatments.
CONCLUSION


Findings contribute new knowledge about patients' and clinicians' perspectives on the role of imaging and spinal specialist opinion in the management of sciatica, and provide important insights for understanding the 'fast-track' pathway, as part of the stratified care model tested in the RCT. Future research into the early referral of patients with sciatica for investigation and specialist opinion should include strategies to support clinician behaviour change; as well as take into account the role of imaging in providing reassurance to patients with severe symptoms in cases where imaging reveals a clear explanation for the patient's pain, and where this is accompanied by a thorough explanation from a trusted clinical expert.",2020,"Both groups felt a key limitation of the pathway was that it did not shorten patient waiting times between their spinal specialist consultation and further treatments.
","['patients with sciatica in primary care', 'Semi-structured interviews were conducted with 20 patients and 20 clinicians (general practitioners, spinal specialist physiotherapists, spinal surgeons']",['magnetic resonance imaging (MRI) scan and spinal specialist opinion'],['patient waiting times'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}]","[{'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",20.0,0.0378034,"Both groups felt a key limitation of the pathway was that it did not shorten patient waiting times between their spinal specialist consultation and further treatments.
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, ST5 5BG, UK. b.saunders@keele.ac.uk.'}, {'ForeName': 'Kika', 'Initials': 'K', 'LastName': 'Konstantinou', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Artus', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Bartlam', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, ST5 5BG, UK.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03483-z']
3067,32680548,Whey protein supplementation reducing fasting levels of anandamide and 2-AG without weight loss in pre-menopausal women with obesity on a weight-loss diet.,"BACKGROUND


Despite the importance of dairy proteins in modifying of metabolic abnormalities, no attention has been given to their effects on endocannabinoids.
METHODS


A total number of 60 obese women were recruited in a 2-month randomized clinical trial. Following random allocation, they were assigned to one of the two groups: control (n = 30) and intervention (n = 30). Then, all the subjects followed a hypocaloric diet of 800 kcal below estimated energy needs. The intervention group received isocaloric weight-loss diet and whey protein powders (30 g/day). Baseline and 2-month fasting anthropometric, blood glucose, serum insulin, insulin resistance, lipid profile, AEA, and 2-AG were measured.
RESULTS


The study groups were homogenous in terms of baseline characteristics (p > 0.05) except for MUFA intake (p = 0.021). There were no significant differences in energy and macronutrient intakes in the intervention group compared to the control group at the end of the study (p > 0.05). The results of the ANCOVA did not show significant reductions in body weight and BMI of the intervention group compared to the control group (p > 0.05); however, WC, body fat, FBS, AEA, 2-AG, total cholesterol, and triglyceride decreased and HDL-c significantly increased in the intervention group compared to the control group (p < 0.05).
CONCLUSIONS


In this study, the effects of simultaneous weight-loss diet and whey protein supplementation on the reduction of endocannabinoids were determined.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials IRCT2017021410181N8 . Registered on March 2017.",2020,There were no significant differences in energy and macronutrient intakes in the intervention group compared to the control group at the end of the study (p > 0.05).,"['A total number of 60 obese women', 'pre-menopausal women with obesity on a weight-loss diet']","['simultaneous weight-loss diet and whey protein supplementation', 'Whey protein supplementation', 'isocaloric weight-loss diet and whey protein powders']","['body weight and BMI', 'energy and macronutrient intakes', 'Baseline and 2-month fasting anthropometric, blood glucose, serum insulin, insulin resistance, lipid profile, AEA, and 2-AG', 'WC, body fat, FBS, AEA, 2-AG, total cholesterol, and triglyceride decreased and HDL-c', 'MUFA intake', 'fasting levels of anandamide and 2-AG without weight loss']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0858892', 'cui_str': 'Triglycerides low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0418789,There were no significant differences in energy and macronutrient intakes in the intervention group compared to the control group at the end of the study (p > 0.05).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Research Center, Faculty of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Aghamohammadi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Research Center, Faculty of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran. v_agamohammadi@yahoo.com.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Research Center, Faculty of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Department of Statistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Trials,['10.1186/s13063-020-04586-7']
3068,32680556,Factors related to dropout in integrative oncology clinical trials: interim analysis of an ongoing comparative effectiveness trial of mindfulness-based cancer recovery and Tai chi/Qigong for cancer health (The MATCH study).,"OBJECTIVE


To examine the factors associated with loss to follow-up (LTFU) in an ongoing preference-based randomized waitlist controlled trial of mindfulness-based cancer recovery (MBCR) and Taichi/Qigong (TCQ) for cancer survivors (the MATCH Study). Hierarchical logistic regression was used to determine the factors associated with LTFU. Predictors included adherence to treatment, preference vs. randomized, type of intervention (MBCR vs. TCQ) and program timing (immediate {IM} vs. waitlist control {WLC} group).
RESULTS


Data indicated that randomization to the WLC group and, once in the intervention, low adherence were the main predictors of LTFU. Participants in the WLC group were 4 times more likely to be LTFU post-randomization [OR 3.96, 95% CI 2.08-7.56, p < 0.005] than those in the IM group. Participants showing low adherence to treatment were 6 times more likely for LTFU post-intervention [5.87 (2.57-13.400; p < 0.005] and 4 times more likely for LTFU 6 months post-intervention [OR 3.93, 95% CI 1.53-10.02, p = 0.01].",2020,"Participants showing low adherence to treatment were 6 times more likely for LTFU post-intervention [5.87 (2.57-13.400; p < 0.005] and 4 times more likely for LTFU 6 months post-intervention [OR 3.93, 95% CI 1.53-10.02, p = 0.01].",['cancer survivors'],"['mindfulness-based cancer recovery and Tai chi', 'mindfulness-based cancer recovery (MBCR) and Taichi/Qigong (TCQ', 'WLC', 'follow-up (LTFU']","['adherence to treatment, preference vs. randomized, type of intervention (MBCR vs. TCQ) and program timing (immediate {IM}\xa0vs. waitlist control {WLC}\xa0group']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",,0.0464124,"Participants showing low adherence to treatment were 6 times more likely for LTFU post-intervention [5.87 (2.57-13.400; p < 0.005] and 4 times more likely for LTFU 6 months post-intervention [OR 3.93, 95% CI 1.53-10.02, p = 0.01].","[{'ForeName': 'Devesh', 'Initials': 'D', 'LastName': 'Oberoi', 'Affiliation': 'Psychosocial Resources, Tom Baker Cancer Centre, Holy Cross Site Phase I, 2202-2 St SW, Calgary, AB, T2S 3C1, Canada.'}, {'ForeName': 'Katherine-Ann L', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Psychosocial Resources, Tom Baker Cancer Centre, Holy Cross Site Phase I, 2202-2 St SW, Calgary, AB, T2S 3C1, Canada.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Pirbhai', 'Affiliation': 'Psychosocial Resources, Tom Baker Cancer Centre, Holy Cross Site Phase I, 2202-2 St SW, Calgary, AB, T2S 3C1, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Guirguis', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, B PMB 130, 200 Elizabeth St, Toronto, ON, M5G 2C4, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Santa Mina', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, B PMB 130, 200 Elizabeth St, Toronto, ON, M5G 2C4, Canada.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Psychosocial Resources, Tom Baker Cancer Centre, Holy Cross Site Phase I, 2202-2 St SW, Calgary, AB, T2S 3C1, Canada. lcarlso@ucalgary.ca.'}]",BMC research notes,['10.1186/s13104-020-05172-5']
3069,32681091,Exhausted T cell signature predicts immunotherapy response in ER-positive breast cancer.,"Responses to immunotherapy are uncommon in estrogen receptor (ER)-positive breast cancer and to date, lack predictive markers. This randomized phase II study defines safety and response rate of epigenetic priming in ER-positive breast cancer patients treated with checkpoint inhibitors as primary endpoints. Secondary and exploratory endpoints included PD-L1 modulation and T-cell immune-signatures. 34 patients received vorinostat, tamoxifen and pembrolizumab with no excessive toxicity after progression on a median of five prior metastatic regimens. Objective response was 4% and clinical benefit rate (CR + PR + SD > 6 m) was 19%. T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder. Tumor lymphocyte infiltration was 0.17%. Only two non-responders had PD-L1 expression >1%. This data defines a novel immune signature in PD-L1-negative ER-positive breast cancer patients who are more likely to benefit from immune-checkpoint and histone deacetylase inhibition (NCT02395627).",2020,"T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder.","['34 patients received', 'ER-positive breast cancer patients treated with', 'PD-L1-negative ER-positive breast cancer patients', 'ER-positive breast cancer']","['checkpoint inhibitors', 'vorinostat, tamoxifen and pembrolizumab']","['PD-L1 modulation and T-cell immune-signatures', 'clinical benefit rate', 'PD-L1 expression', 'Objective response', 'T-cell exhaustion (CD8 +\xa0 PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ', 'Tumor lymphocyte infiltration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]",34.0,0.0718826,"T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Terranova-Barberio', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Nela', 'Initials': 'N', 'LastName': 'Pawlowska', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Dhawan', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Moasser', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Melisko', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Rugo', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Roshun', 'Initials': 'R', 'LastName': 'Rahimi', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Deal', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Daud', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Rosenblum', 'Affiliation': 'Department of Dermatology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Munster', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA. pamela.munster@ucsf.edu.'}]",Nature communications,['10.1038/s41467-020-17414-y']
3070,32681118,Physiological responses to moderate intensity continuous and high-intensity interval exercise in persons with paraplegia.,"STUDY DESIGN


Randomized crossover.
OBJECTIVES


To test differences in the duration and magnitude of physiological response to isocaloric moderate intensity continuous (MICE) and high-intensity interval exercise (HIIE) sessions in persons with spinal cord injury (SCI).
SETTING


Academic medical center in Miami, FL, USA.
METHODS


Ten adult men (mean ± s.d.; 39 ± 10 year old) with chronic (13.2 ± 8.8 year) paraplegia (T2-T10) completed a graded exercise test. Then, in a randomized order, participants completed MICE and HIIE for a cost of 120 kcal. MICE was performed at 24.6% PO peak . During HIIE, exercise was completed in 2 min work and recovery phases at 70%:10% PO peak .
RESULTS


MICE and HIIE were isocaloric (115.9 ± 21.8 and 116.6 ± 35.0 kcal, respectively; p = 0.903), but differed in duration (39.8 ± 4.6 vs 32.2 ± 6.2 min; p < 0.001) and average respiratory exchange ratio (RER; 0.90 ± 0.08 vs 1.01 ± 0.07; p = 0.002). During MICE, a workrate of 24.6 ± 6.7% PO peak  elicited a V̇O 2  of 53.1 ± 6.5% V̇O 2peak  (10.1 ± 2.2 ml kg -1  min -1 ). During HIIE, a workrate at 70% PO peak  elicited 88.3 ± 6.7% V̇O 2peak  (16.9 ± 4.2 ml kg -1  min -1 ), and 29.4 ± 7.7% of the session was spent at or above 80% V̇O 2peak . During HIIE working phase, RER declined from the first to last interval (1.08 ± 0.07 vs 0.98 ± 0.09; p < 0.001), reflecting an initially high but declining glycolytic rate.
CONCLUSIONS


Compared with MICE, HIIE imposed a greater physiological stimulus while requiring less time to achieve a target caloric expenditure. Thus, exercise intensity might be an important consideration in the tailoring of exercise prescription to address the cardiometabolic comorbidities of SCI.",2020,"During HIIE working phase, RER declined from the first to last interval (1.08 ± 0.07 vs 0.98 ± 0.09; p < 0.001), reflecting an initially high but declining glycolytic rate.
","['Academic medical center in Miami, FL, USA', ' 39\u2009±\u200910\u2009year old) with chronic (13.2\u2009±\u20098.8\u2009year) paraplegia (T2-T10) completed a', 'persons with paraplegia', 'persons with spinal cord injury (SCI', 'Ten adult men (mean\u2009±']","['moderate intensity continuous and high-intensity interval exercise', 'isocaloric moderate intensity continuous (MICE) and high-intensity interval exercise (HIIE) sessions', 'MICE', 'graded exercise test']",['average respiratory exchange ratio'],"[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}]",10.0,0.115524,"During HIIE working phase, RER declined from the first to last interval (1.08 ± 0.07 vs 0.98 ± 0.09; p < 0.001), reflecting an initially high but declining glycolytic rate.
","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'McMillan', 'Affiliation': 'The Miami Project to Cure Paralysis, Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, FL, USA. dmcmillan@med.miami.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Maher', 'Affiliation': 'Department of Health, University of Bath, Bath, UK.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Jacobs', 'Affiliation': 'Department of Kinesiology and Sport Science, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Nash', 'Affiliation': 'The Miami Project to Cure Paralysis, Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'James L J', 'Initials': 'JLJ', 'LastName': 'Bilzon', 'Affiliation': 'Department of Health, University of Bath, Bath, UK.'}]",Spinal cord,['10.1038/s41393-020-0520-9']
3071,32681134,Stimulus modality influences session-to-session transfer of training effects in auditory and tactile streaming-based P300 brain-computer interfaces.,"Despite recent successes, patients suffering from locked-in syndrome (LIS) still struggle to communicate using vision-independent brain-computer interfaces (BCIs). In this study, we compared auditory and tactile BCIs, regarding training effects and cross-stimulus-modality transfer effects, when switching between stimulus modalities. We utilized a streaming-based P300 BCI, which was developed as a low workload approach to prevent potential BCI-inefficiency. We randomly assigned 20 healthy participants to two groups. The participants received three sessions of training either using an auditory BCI or using a tactile BCI. In an additional fourth session, BCI versions were switched to explore possible cross-stimulus-modality transfer effects. Both BCI versions could be operated successfully in the first session by the majority of the participants, with the tactile BCI being experienced as more intuitive. Significant training effects were found mostly in the auditory BCI group and strong evidence for a cross-stimulus-modality transfer occurred for the auditory training group that switched to the tactile version but not vice versa. All participants were able to control at least one BCI version, suggesting that the investigated paradigms are generally feasible and merit further research into their applicability with LIS end-users. Individual preferences regarding stimulus modality should be considered.",2020,Significant training effects were found mostly in the auditory BCI group and strong evidence for a cross-stimulus-modality transfer occurred for the auditory training group that switched to the tactile version but not vice versa.,['20 healthy participants to two groups'],"['training either using an auditory BCI or using a tactile BCI', 'auditory training']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],20.0,0.0239414,Significant training effects were found mostly in the auditory BCI group and strong evidence for a cross-stimulus-modality transfer occurred for the auditory training group that switched to the tactile version but not vice versa.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ziebell', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany. philipp.ziebell@uni-wuerzburg.de.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stümpfig', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Eidel', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Kleih', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kübler', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Latoschik', 'Affiliation': 'Institute of Computer Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Halder', 'Affiliation': 'School of Computer Science and Electronic Engineering (CSEE), University of Essex, Colchester, UK.'}]",Scientific reports,['10.1038/s41598-020-67887-6']
3072,32681219,Evaluating the efficacy and safety of vascular IPL for treatment of acute cutaneous leishmaniasis: a randomized controlled trial.,"Treatment of cutaneous leishmaniasis (CL) continues to be a health concern, and alternative therapies with fewer side effects are substantially needed. This study aimed to determine the efficacy of intense pulsed light (IPL) with wavelength spectrum affecting vascular lesions on acute cutaneous leishmaniasis. In this randomized clinical trial study, 30 patients with acute CL were enrolled. Baseline clinical and demographic data were recorded in the checklist after obtaining written informed consent. Patients were randomly allocated to receive either IPL fortnightly (intervention group) or intralesional meglumine antimoniate (MA) weekly (control group) over 10 weeks. Patients were assessed every 2 weeks to determine the size of induration and improvement rate of lesions. Follow-up visits were arranged at 3rd and 6th months. Overall, 15 patients (21 lesions) in the intervention group and 15 patients (22 lesions) in the control group were studied. The size of lesions in the control group was significantly higher at the baseline (P = 0.014) and the second week (P = 0.034), and significantly lower in the eighth week (P = 0.009), compared with the intervention group. The size of lesions in the control group changed during the study (P < 0.001), whereas changes were not significant in the intervention group. The trend of changes in size of lesions was faster in the control group (P < 0.001). More patients in the control group had higher improvement rate at the sixth (P = 0.005) and tenth (P < 0.001) weeks. At the end of study, the cure rate was 35% (7 out of 20 lesions) in intervention group and 81.8% (18 out of 22 lesions) in the control group. Complete response happened earlier in the control group (P < 0.001). None of the lesions that were cured before the tenth week relapsed after 6 months. The frequency of blistering was significantly higher in intervention group (P = 0.001). Our results indicated that IPL with wavelength spectrum affecting vascular lesions was inferior to intralesional MA in treatment of CL. However, it can be considered as a second-line option, especially in patients with limitations for use of MA. Trial registry:  https://www.irct.ir/trial/34246 IRCT20140414017271N5.",2020,"The size of lesions in the control group was significantly higher at the baseline (P = 0.014) and the second week (P = 0.034), and significantly lower in the eighth week (P = 0.009), compared with the intervention group.","['30 patients with acute CL were enrolled', 'acute cutaneous leishmaniasis']","['vascular IPL', 'IPL fortnightly (intervention group) or intralesional meglumine antimoniate (MA) weekly (control group) over 10\xa0weeks', 'intense pulsed light (IPL', 'intralesional MA']","['cure rate', 'frequency of blistering', 'size of induration and improvement rate of lesions', 'efficacy and safety', 'improvement rate', 'size of lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C1096768', 'cui_str': 'meglumine antimoniate'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}]",30.0,0.0324962,"The size of lesions in the control group was significantly higher at the baseline (P = 0.014) and the second week (P = 0.034), and significantly lower in the eighth week (P = 0.009), compared with the intervention group.","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Tafazzoli', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Nahidi', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mashayekhi Goyonlo', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Morovatdar', 'Affiliation': 'Clinical Research Development Unit, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Pouran', 'Initials': 'P', 'LastName': 'Layegh', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Layeghpo@mums.ac.ir.'}]",Lasers in medical science,['10.1007/s10103-020-03102-2']
3073,32681350,A urinary catheter valve is non-inferior to continuous bladder drainage with respect to post-operative UTIs: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


Urinary tract infections (UTIs) are common with indwelling catheter use. Our primary aim was to compare UTI rates in women sent home after surgery with continuous bladder drainage versus a urinary catheter valve.
METHODS


This was a non-inferiority prospective randomized controlled study between June 2016 to June 2019. Women who were being discharged home with a Foley catheter following urogynecologic surgery due to urinary retention were randomized to a continuous urinary drainage bag or a urinary catheter valve. The primary outcome of this study was post-operative UTI rates within 30 days of surgery. The secondary outcome was patient satisfaction, as determined by a Foley satisfaction questionnaire.
RESULTS


Out of 97 women, 51 were randomized to continuous drainage and 46 to the urinary catheter valve. Comparing UTI rates, the urinary catheter valve (32.6%) was non-inferior to the continuous urinary drainage bag (33.3%). The upper bound of the 95% CI was less than the predetermined non-inferiority margin (difference 0.7%, 95% CI: -0.195, 0.180), and therefore non-inferiority criteria were met. Patients were more satisfied with the urinary catheter valve than with the continuous drainage bag (p ≤ 0.001).
CONCLUSIONS


Use of this urinary catheter valve increased patient satisfaction without affecting the post-operative UTI rate. This easy and inexpensive device could help patients have a better catheter experience and should be considered in women being discharged home with a urinary catheter.",2020,"Patients were more satisfied with the urinary catheter valve than with the continuous drainage bag (p ≤ 0.001).
","['97 women', 'women sent home after surgery with', 'women being discharged home with a urinary catheter', 'Women who were being discharged home with a Foley catheter following urogynecologic surgery due to urinary retention', 'June 2016 to June 2019']","['continuous urinary drainage bag or a urinary catheter valve', 'continuous drainage and 46 to the urinary catheter valve', 'continuous bladder drainage versus a urinary catheter valve']","['satisfied with the urinary catheter valve', 'patient satisfaction', 'patient satisfaction, as determined by a Foley satisfaction questionnaire', 'post-operative UTI rates', 'urinary catheter valve', 'UTI rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0180497', 'cui_str': 'Drainage bag'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0565198', 'cui_str': 'Drainage of bladder'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]",97.0,0.134087,"Patients were more satisfied with the urinary catheter valve than with the continuous drainage bag (p ≤ 0.001).
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dhariwal', 'Affiliation': 'Division of Urogynecology and Female Reconstructive Surgery, Atlantic Health System, Morristown, NJ, USA. laura.dhariwal@atlantichealth.org.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': 'Atlantic Center for Research, Atlantic Health System, 435 South Street Suit 370, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Salamon', 'Affiliation': 'Division of Urogynecology and Female Reconstructive Surgery, Atlantic Health System, Morristown, NJ, USA.'}]",International urogynecology journal,['10.1007/s00192-020-04436-9']
3074,32673261,"Evidence-Based Decision Aid for Patients With Parkinson Disease: Protocol for Interview Study, Online Survey, and Two Randomized Controlled Trials.","BACKGROUND


Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson disease, both pharmacological and surgical approaches can be applied.
OBJECTIVE


In this research project, a series of studies will be conducted to investigate how decision aids for patients with idiopathic Parkinson disease should be designed in order to support the decision-making process.
METHODS


In Study 1a, qualitative interviews will be conducted to determine which needs frequently occur for patients with idiopathic Parkinson disease. In Study 1b, the identified needs will then be rated for personal relevance by an independent group of patients in an online survey. In Study 2, a randomized controlled trial will be used to pretest different decision aids in a sample group of people who do not have a medical background and who do not have Parkinson disease. In Study 3, a randomized controlled trial will be used to investigate the effect of the decision aids that had been evaluated as positive in Study 2 with patients who have idiopathic Parkinson disease.
RESULTS


This series of studies received ethical approval in January 2020. As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively. It is planned to present the results and analyses at international conferences and to submit the results to peer-reviewed journals for publication, once the studies have been completed. The findings will also be shared with clinicians and patients through presentations at information events.
CONCLUSIONS


This series of studies is intended to result in an evidence-based decision aid for patients with idiopathic Parkinson disease in order to support the informed and reflected shared decision-making process. We further intend to contribute to a deeper understanding of the individual preferences of patients with idiopathic Parkinson disease and the impact of those preferences on treatment decisions.",2020,"As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively.","['Patients With Parkinson Disease', 'patients with idiopathic Parkinson disease', 'patients who have idiopathic Parkinson disease', 'sample group of people who do not have a medical background and who do not have Parkinson disease']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",[],[],2.0,0.0680163,"As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bientzle', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kimmerle', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eggeling', 'Affiliation': 'Leibniz-Institut für Wissensmedien, Tübingen, Germany.'}, {'ForeName': 'Idil', 'Initials': 'I', 'LastName': 'Cebi', 'Affiliation': 'Division of Functional and Restorative Neurosurgery and Tübingen NeuroCampus, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Department of Neurodegenerative Diseases, Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gharabaghi', 'Affiliation': 'Division of Functional and Restorative Neurosurgery and Tübingen NeuroCampus, University of Tübingen, Tübingen, Germany.'}]",JMIR research protocols,['10.2196/17482']
3075,32673262,Implementing mHealth Interventions in a Resource-Constrained Setting: Case Study From Uganda.,"BACKGROUND


Mobile health (mHealth) interventions are becoming more common in low-income countries. Existing research often overlooks implementation challenges associated with the design and technology requirements of mHealth interventions.
OBJECTIVE


We aimed to characterize the challenges that we encountered in the implementation of a complex mHealth intervention in Uganda.
METHODS


We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation. We incorporated digital fingerprinting for patient identification in both study arms and automated SMS messages in the intervention arm only. A local research team systematically documented challenges to implementation in biweekly site visit reports, project management reports, and minutes from biweekly conference calls. We then classified these challenges using the Consolidated Framework for Implementation Research (CFIR).
RESULTS


We identified challenges in three principal CFIR domains: (1) intervention characteristics, (2) inner setting, and (3) characteristics of implementers. The adaptability of the app to the local setting was limited by software and hardware requirements. The complexity and logistics of implementing the intervention further hindered its adaptability. Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation. After experiencing technological failures, their trust in the technology declined along with their use of it. Finally, complex data structures impeded the development and execution of a data management plan that would allow for articulation of goals and provide timely feedback to study staff, CHWs, and participants.
CONCLUSIONS


mHealth technologies have the potential to make delivery of public health interventions more direct and efficient, but we found that a lack of adaptability, excessive complexity, loss of trust among end users, and a lack of effective feedback systems can undermine implementation, especially in low-resource settings where digital services have not yet proliferated. Implementers should anticipate and strive to avoid these barriers by investing in and adapting to local human and material resources, prioritizing feedback from end users, and optimizing data management and quality assurance procedures.
TRIAL REGISTRATION


Pan-African Clinical Trials Registration PACTR201509000877140; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=877.",2020,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"['community health workers (CHWs', 'We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation', 'Uganda']",[],[],"[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],[],,0.074366,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Armstrong-Hough', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Babirye', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mark', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ayakaka', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'J Lucian', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}]",JMIR mHealth and uHealth,['10.2196/19552']
3076,32673264,HIV Self-Testing to Promote Serostatus Disclosure Among Men Who Have Sex With Men in China: Protocol for a Stepped Wedge Randomized Controlled Trial.,"BACKGROUND


Disclosure of HIV serostatus is important for the prevention of HIV infection among men who have sex with men (MSM). However, knowledge of sexual partners' HIV status among MSM in China is low. As a complement to HIV testing services, HIV self-testing (HIVST) has considerable potential to promote serostatus disclosure.
OBJECTIVE


The primary objective of our trial is to evaluate the effect of HIVST on improving serostatus disclosure to sexual partners. We hypothesize that MSM in an intervention condition will have a higher awareness of the HIV status of their sexual partners compared with MSM in the control condition. The secondary aims are to evaluate (i) changes in sexual behaviors after disclosure of HIV status by sexual partners, (ii) promotion of the frequency of HIV and syphilis testing on participants and their sexual partners, and (iii) factors that restrict the disclosure of HIV infection to sexual partners. We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition.
METHODS


A stepped wedge randomized controlled trial will be conducted throughout China. Study recruitment of 800 MSM will be promoted through advertisements released on WeChat public accounts. Individuals who are born biologically male, aged ≥18 years, HIV negative, and who have not undergone HIV testing in the past 3 months will be recruited. Eligible men will be randomly divided (1:1:1:1) into four groups and randomized. The group cluster will initiate the intervention so that participants will be provided with 2-4 free finger prick-based HIVST kits until trial completion. The intervention period for participants in each of the four groups will be initiated at 3-month intervals. Men in both groups will be required to complete a baseline and four follow-up surveys every 3 months. The primary intervention outcome will evaluate the effect of the distribution of HIVST kits on improvement in the disclosure of sexual partners' HIV status. The secondary outcomes will be changes in sexual behaviors after disclosure of HIV status from sexual partners, the promotion of the frequency of HIVST on participants and their sexual partners, and the factors that restrict disclosure of HIV status to sexual partners.
RESULTS


Subject recruitment began in August 2018. The first round of follow-up surveys post intervention is complete, with three rounds remaining to be done. Data analysis was scheduled for April 2020 and the results will be disseminated through conferences and peer-reviewed publications.
CONCLUSIONS


Few studies have evaluated interventions to increase knowledge of sexual partners' HIV status among MSM. Our trial will provide information on the link between HIVST and HIV serostatus disclosure. The findings of this trial will facilitate the implementation of HIVST services to help control the spread of HIV among MSM in China.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1800019453; http://www.chictr.org.cn/showproj.aspx?proj=30158.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17788.",2020,"We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition.
","['Eligible men', 'Individuals who are born biologically male, aged ≥18 years, HIV negative, and who have not undergone HIV testing in the past 3 months will be recruited', 'Men', 'Who Have Sex With Men in China', 'men who have sex with men (MSM']","['MSM', 'HIV self-testing (HIVST', 'HIVST']","[""effect of the distribution of HIVST kits on improvement in the disclosure of sexual partners' HIV status"", 'sexual behaviors', 'serostatus disclosure to sexual partners', 'sexual behaviors after disclosure of HIV status from sexual partners, the promotion of the frequency of HIVST on participants and their sexual partners, and the factors that restrict disclosure of HIV status to sexual partners']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",800.0,0.0993102,"We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition.
","[{'ForeName': 'Tianyi', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Erlei', 'Initials': 'E', 'LastName': 'Peng', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Chu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Willa', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}]",JMIR research protocols,['10.2196/17788']
3077,32673265,Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients.
OBJECTIVE


The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery.
METHODS


This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions.
RESULTS


The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021.
CONCLUSIONS


This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures.
TRIAL REGISTRATION


European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17826.",2020,The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass.,"['cardiac surgery with cardiopulmonary bypass', 'adult patient cardiac surgery', 'adult patients undergoing coronary revascularization, valve replacement, or combined procedures', 'patients undergoing these procedures', 'Puerta de Hierro Majadahonda University Hospital in Spain', 'adult patients', 'Adult Cardiac Surgery', 'elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury', '474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass', 'pediatric patients undergoing cardiac surgery with cardiopulmonary bypass']","['DNS', 'cardioplegia solutions', 'DNS or Cardi-Braun blood cardioplegia solution', 'Del Nido Cardioplegia Versus Cold Blood Cardioplegia', 'Cardi-Braun blood cardioplegia solution']","['myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",474.0,0.161391,The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Garcia-Suarez', 'Affiliation': 'Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia Fernandez', 'Affiliation': 'Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sanz', 'Affiliation': 'Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martinez Lopez', 'Affiliation': 'Department of Cardiovascular Surgery, Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Reques', 'Affiliation': 'Department of Cardiovascular Surgery, Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Forteza Gil', 'Affiliation': 'Department of Cardiovascular Surgery, Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain.'}]",JMIR research protocols,['10.2196/17826']
3078,32673267,Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention.,"BACKGROUND


Multicomponent family interventions underline current best practice in childhood obesity treatment. Mobile health (mHealth) adjuncts that address eating and physical activity behaviors have shown promise in clinical studies.
OBJECTIVE


This study aimed to describe process methods for applying an mHealth intervention to reduce the rate of eating and monitor physical activity among children with obesity.
METHODS


The study protocol was designed to incorporate 2 mHealth apps as an adjunct to usual care treatment for obesity. Children and adolescents (aged 9-16 years) with obesity (BMI ≥98th centile) were recruited in person from a weight management service at a tertiary health care center in the Republic of Ireland. Eligible participants and their parents received information leaflets, and informed consent and assent were signed. Participants completed 2 weeks of baseline testing, including behavioral and quality of life questionnaires, anthropometry, rate of eating by Mandolean, and physical activity level using a smart watch and the myBigO smartphone app. Thereafter, participants were randomized to the (1) intervention (usual clinical care+Mandolean training to reduce the rate of eating) or (2) control (usual clinical care) groups. Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied. At the end of a 4-week treatment period, participants repeated the 2-week testing period. Process evaluation measures included recruitment, study retention, fidelity parameters, acceptability, and user satisfaction.
RESULTS


A total of 20 participants were enrolled in the study. A web-based randomization system assigned 8 participants to the intervention group and 12 participants to the control group. Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%). Intervention participants undertook a median of 1.0 training meal using Mandolean (25th centile 0, 75th centile 9.3), which represented 19.2% of planned intervention exposure. Only 50% (9/18) of participants with smart watches logged physical activity data. Significant differences in psychosocial profile were observed at baseline between the groups. The Child Behavior Checklist (CBCL) mean total score was 71.7 (SD 3.1) in the intervention group vs 57.6 (SD 6.6) in the control group, t-test P<.001, and also different among those who completed the planned protocol compared with those who withdrew early (CBCL mean total score 59.0, SD 9.3, vs 67.9, SD 5.6, respectively; t-test P=.04).
CONCLUSIONS


A high early attrition rate was a key barrier to full study implementation. Perceived task burden in combination with behavioral issues may have contributed to attrition. Low exposure to the experimental intervention was explained by poor acceptability of Mandolean as a home-based tool for treatment. Self-monitoring using myBigO and the smartwatch was acceptable among this cohort. Further technical and usability studies are needed to improve adherence in our patient group in the tertiary setting.",2020,"Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%).","['children with obesity', 'A total of 20 participants were enrolled in the study', 'Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied', 'Pediatric Obesity Treatment', 'Children and adolescents (aged 9-16 years) with obesity (BMI ≥98th centile) were recruited in person from a weight management service at a tertiary health care center in the Republic of Ireland']","['intervention (usual clinical care+Mandolean training to reduce the rate of eating) or (2) control (usual clinical care', 'Multicomponent Intervention']","['recruitment, study retention, fidelity parameters, acceptability, and user satisfaction', 'Attrition rates', 'rate of eating and monitor physical activity', 'behavioral and quality of life questionnaires, anthropometry, rate of eating by Mandolean, and physical activity level', 'psychosocial profile', 'Child Behavior Checklist (CBCL) mean total score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0668364,"Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Browne', 'Affiliation': 'School Public Health, Physiotherapy & Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'M-Tahar', 'Initials': 'MT', 'LastName': 'Kechadi', 'Affiliation': 'Insight Centre for Data Analytics, School of Computer Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'School of Sociology, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Mckenzie', 'Initials': 'M', 'LastName': 'Dow', 'Affiliation': 'School Public Health, Physiotherapy & Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Tully', 'Affiliation': 'Division of Population Health Sciences, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Gerardine', 'Initials': 'G', 'LastName': 'Doyle', 'Affiliation': 'UCD Michael Smurfit Graduate Business School, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': ""O'Malley"", 'Affiliation': 'Division of Population Health Sciences, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",JMIR mHealth and uHealth,['10.2196/16925']
3079,31912903,Refractory neutrophil activation in type 2 diabetics with chronic periodontitis.,"BACKGROUND


Inflammation increases diabetes mellitus type 2 (T2DM) progression and severity. T2DM patients are at high risk of the rapid development of chronic periodontitis (CP). Topical presence, high numbers, and bactericidal effects of immune cells are challenged by augmented antigen-induced inflammation, which promotes both diseases.
OBJECTIVES


To investigate gingival cellular inflammatory responses in individuals with previously undiagnosed T2DM with CP or CP alone and in systemically and periodontally healthy controls (H) in vivo and to establish an ex vivo technique permitting quantitative and qualitative assessments of gingival crevicular immune cells.
MATERIALS AND METHODS


T2DM + CP, CP, and H individuals (n = 10, each) received a 2-week oral hygiene regimen (OHR). Afterwards, a noninvasive sampling technique was performed to evaluate gingival inflammation induced under standardized conditions in vivo, that is, in the absence of severe periodontal destruction and inflammation at clinically healthy sites. Stimuli (casein/test or phosphate-buffered saline w/o. Ca 2+  or Mg 2+  , PBS (-/-)  /control) were randomly applied contralaterally in the gingival sulci of participants' upper dentes canini. One day after completion of the OHR, gingival crevicular fluid (GCF) was kinetically assayed between the time of the baseline (BL) measurement and 55 minutes. Polymorphonuclear leukocyte (PMN) content (PMN GCF  ) was quantitated at an optimum time of 35 minutes. PMN GCF  counts reflect local inflammation. Ex vivo samples were fluorimetrically labeled, gated according to the donor's peripheral blood polymorphonuclear neutrophils (PMN PB  ), and then counted, employing flow cytometry.
RESULTS


PMN GCF  counts in unstimulated gingival crevices (at BL) in the T2DM + CP group were higher than those in the CP and H groups. PMN GCF  counts were elevated in casein vs PBS (-/-)  -stimulated gingival crevices in all groups. Patients with T2DM + CP showed increased PMN GCF  counts compared to those with CP (P = .035) according to scatter plots. CD45 +  counts in the stimulated sites in T2DM + CP patients were higher than those in CP and H patients (P = .041). Under stimulation conditions, the CD45 +  counts differed from those under placebo conditions (P = .019), indicating augmented, inducible inflammatory leukocyte infiltrate in T2DM + CP patients.
CONCLUSIONS


This noninvasive technique permits quantitative assessment of (experimental) gingival inflammation in vivo, revealing an influence of T2DM + CP on the number of primary immune cells in the gingival crevice. Patients who are challenged with (local) leukocytosis are likely at risk of collateral damage to the gingival crevice neighboring tissues, favoring the severity and progression of CP and consequently T2DM (www.clinicaltrials.gov NCT01848379).",2020,"Under stimulation conditions, the CD45 +  counts differed from those under placebo conditions (P = .019), indicating augmented, inducible inflammatory leukocyte infiltrate in T2DM + CP patients.
","['individuals with previously undiagnosed T2DM with CP or CP alone and in systemically and periodontally healthy controls (H', 'type 2 diabetics with chronic periodontitis', 'T2DM\xa0+\xa0CP, CP, and H individuals (n\xa0=\xa010, each) received a']","['Ca 2+  or Mg 2+  , PBS (-/-)  /control', 'Stimuli (casein/test or phosphate-buffered saline w/o', '2-week oral hygiene regimen (OHR']","['CD45 +  counts', 'Refractory neutrophil activation', 'Polymorphonuclear leukocyte (PMN) content (PMN GCF  ', 'PMN GCF  counts', 'OHR, gingival crevicular fluid (GCF']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0054961', 'cui_str': 'Lymphocyte antigen CD45'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0242599', 'cui_str': 'Neutrophil Activation'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3693482', 'cui_str': 'Giant cell fibroblastoma'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",,0.0223256,"Under stimulation conditions, the CD45 +  counts differed from those under placebo conditions (P = .019), indicating augmented, inducible inflammatory leukocyte infiltrate in T2DM + CP patients.
","[{'ForeName': 'Jens Martin', 'Initials': 'JM', 'LastName': 'Herrmann', 'Affiliation': 'School of Dental Medicine, Department of Periodontology, Justus-Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Sarah Kirsten', 'Initials': 'SK', 'LastName': 'Sonnenschein', 'Affiliation': 'School of Dental Medicine, Department of Periodontology, Justus-Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Sabine Elisabeth', 'Initials': 'SE', 'LastName': 'Groeger', 'Affiliation': 'School of Dental Medicine, Department of Periodontology, Justus-Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Ewald', 'Affiliation': 'Internal Medicine III-Endocrinology, Justus-Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Borros', 'Initials': 'B', 'LastName': 'Arneth', 'Affiliation': 'Laboratory Medicine and Pathobiochemistry, Justus-Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Meyle', 'Affiliation': 'School of Dental Medicine, Department of Periodontology, Justus-Liebig University of Giessen, Giessen, Germany.'}]",Journal of periodontal research,['10.1111/jre.12717']
3080,31732868,An observational analysis of meal patterns in overweight and obese pregnancy: exploring meal pattern behaviours and the association with maternal and fetal health measures.,"BACKGROUND


Nutrient intakes are known to be poorer among pregnant women with raised body mass index (BMI) than those with a healthy BMI. While meal patterns have the potential to influence obstetric, metabolic and anthropometric measures for mother and infant, limited data exists regarding meal patterns among pregnant women with raised BMI.
AIM


To identify categories of meal patterns among pregnant women with overweight and obesity and determine whether patterns change with advancing gestation. To determine if maternal meal patterns are associated with dietary intakes and pregnancy outcomes.
METHODS


Prospective, observational analysis of pregnant women (n = 143) (BMI 25-39.9 kg/m 2 ). Meal pattern data were analysed from 3-day food diaries at 16 and 28 weeks' gestation. Outcomes include maternal blood glucose, insulin resistance, gestational diabetes, gestational weight gain and infant anthropometry.
RESULTS


Three meal pattern categories were identified: 'main meal dominant' (3 main eating occasions + 0-3 snacks), 'large meal dominant' (≤ 2 main eating occasions + < 2 snacks), and 'snack dominant' (3 main eating occasions + > 3 snacks and ≤ 2 main + ≥ 2 snacks). A main meal-dominant pattern prevailed at 16 weeks' (85.3%) and a snack-dominant pattern at 28 weeks' (68.5%). Dietary glycaemic index was lower among the main meal versus large meal-dominant pattern at 28 weeks (P = 0.018). Infant birth weight (kg) and macrosomia were highest among participants with a large meal-dominant pattern at 28 weeks (P = 0.030 and P = 0.008, respectively).
CONCLUSION


Women with raised BMI changed eating patterns as pregnancy progressed, moving from main meal-dominant to snack-dominant patterns. Large meal-dominant meal patterns in later pregnancy were associated with higher glycaemic index and greater prevalence of macrosomia.",2020,Dietary glycaemic index was lower among the main meal versus large meal-dominant pattern at 28 weeks (P = 0.018).,"['pregnant women with raised BMI', 'pregnant women with raised body mass index (BMI) than those with a healthy BMI', 'overweight and obese pregnancy', 'pregnant women with overweight and obesity and determine whether patterns change with advancing gestation', 'pregnant women (n\u2009=\u2009143']",[],"['Dietary glycaemic index', 'glycaemic index and greater prevalence of macrosomia', 'Infant birth weight (kg) and macrosomia', 'maternal blood glucose, insulin resistance, gestational diabetes, gestational weight gain and infant anthropometry']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4517573', 'cui_str': '143'}]",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",,0.0534879,Dietary glycaemic index was lower among the main meal versus large meal-dominant pattern at 28 weeks (P = 0.018).,"[{'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Ainscough', 'Affiliation': 'UCD Perinatal Research Centre, Obstetrics & Gynaecology, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Kennelly', 'Affiliation': 'UCD Perinatal Research Centre, Obstetrics & Gynaecology, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Lindsay', 'Affiliation': 'UCD Perinatal Research Centre, Obstetrics & Gynaecology, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Eileen C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'UCD Perinatal Research Centre, Obstetrics & Gynaecology, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': ""O'Sullivan"", 'Affiliation': 'UCD Perinatal Research Centre, Obstetrics & Gynaecology, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehegan', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Eileen R', 'Initials': 'ER', 'LastName': 'Gibney', 'Affiliation': 'UCD Institute of Food and Health, School of Agriculture and Food Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, Obstetrics & Gynaecology, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland. fionnuala.mcauliffe@ucd.ie.'}]",Irish journal of medical science,['10.1007/s11845-019-02099-0']
3081,32678777,The intraocular pressure responses to oral academic examination: The influence of perceived levels of public speaking anxiety.,"We examined the intraocular pressure responsiveness to oral examination stress, as well as the mediating role of the perceived levels of public speaking anxiety on intraocular pressure changes. Thirty-two university students (intervention group) publicly defended their degree final project, and intraocular pressure and perceived levels of stress were measured before and after the oral presentation, and after 10 min of recovery. The control group (n = 32) was not exposed to any stressful situation, and the dependent measures were taken at the same time points. All participants completed the public speaking anxiety scale. The intervention group exhibited higher intraocular pressure values before the oral presentation (corrected p-values<0.001), with these changes being positively associated with the perceived levels of public speaking anxiety (p < 0.001, r = 0.71). Our results reveal a mediating role of public speaking anxiety on the intraocular pressure responsiveness to oral examination stress, and highlight the utility of intraocular pressure as an indicator of stress in applied situations.",2020,"The intervention group exhibited higher intraocular pressure values before the oral presentation (corrected p-values<0.001), with these changes being positively associated with the perceived levels of public speaking anxiety (p < 0.001, r = 0.71).",['Thirty-two university students (intervention group) publicly defended their'],[],"['intraocular pressure responses', 'degree final project, and intraocular pressure and perceived levels of stress', 'perceived levels of public speaking anxiety', 'public speaking anxiety scale', 'intraocular pressure values']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0271671,"The intervention group exhibited higher intraocular pressure values before the oral presentation (corrected p-values<0.001), with these changes being positively associated with the perceived levels of public speaking anxiety (p < 0.001, r = 0.71).","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Spain. Electronic address: beadondo@correo.ugr.es.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez-Rodríguez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Spain.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103158']
3082,32678808,Letter to the editor - Participation of medical students from Latin America in the COVID-19 pandemic.,,2020,,[],[],[],[],[],[],,0.0151271,,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ponce-Torres', 'Affiliation': 'Facultad de Medicina Humana, Universidad de San Martín de Porres, Lima, Perú. Address: Alameda del Corregidor 1531, La Molina, Lima, Perú. Email: christianfpt01@gmail.com. ORCID: 0000-0002-7745-8875.'}]",Medwave,['10.5867/medwave.2020.06.7968']
3083,32678852,The effect of comprehensive intervention for childhood obesity on dietary diversity among younger children: Evidence from a school-based randomized controlled trial in China.,"BACKGROUND


Little evidence from developing countries on dietary transition demonstrates the effects of comprehensive childhood obesity interventions on dietary diversity and food variety among younger children. This study aimed to evaluate the effects of comprehensive childhood obesity interventions on dietary diversity among younger children.
METHODS


A total of 4846 children aged 7-13 years were included based on a multicenter randomized controlled trial for childhood obesity interventions in 38 primary schools. Nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention including both NE and PA (CNP) were carried out separately for 2 semesters. Dietary Diversity Score (DDS9 and DDS28 for 9 and 28 food groupings, respectively), Food Variety Score (FVS, the number of food items) and the proportions of different foods consumed were calculated according to the food intake records collected with the 24-h dietary recall method.
RESULTS


The intervention effects per day of comprehensive intervention group were 0 (95% Confidence Interval (CI): 0, 0.1; p = 0.382) on DDS9, 0.1 (95% CI: -0.1, 0.2; p = 0.374) on DDS28 and 0.1 (95% CI: -0.1, 0.3; p = 0.186) on FVS of overall diet, which was 0.1 (95% CI: 0, 0.1; p < 0.001) on DDS9, 0 (95% CI: 0, 0.1; p = 0.168) on DDS28 and 0.1 (95% CI: 0, 0.1; p = 0.067) on FVS of dietary scores of breakfast only. Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group. Decreasing side effect on dietary diversity and food variety were found for PA intervention, but not for NE intervention only.
CONCLUSIONS


Though the comprehensive obesity intervention didn't improve the overall dietary diversity per day, the positive intervention effects were observed on breakfast foods and some foods' consumption.",2020,"Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group.","['younger children', '4846 children aged 7-13 years', '38 primary schools']","['comprehensive childhood obesity interventions', 'childhood obesity interventions', 'comprehensive intervention', 'Nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention including both NE and PA (CNP', 'CNP']","['Dietary Diversity Score (DDS9 and DDS28', 'FVS of dietary scores', 'dietary diversity', 'Food Variety Score ', 'cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions', 'FVS of overall diet', 'overall dietary diversity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]","[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236026', 'cui_str': 'Fetal valproate syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",4846.0,0.0989589,"Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group.","[{'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ecker', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing, China.'}, {'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Tingyu', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Chongqing Children's Hospital, Chongqing, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Harbin Medical University, Harbin, China.'}, {'ForeName': 'Guifa', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Public Health, Shandong University, Jinan, China.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Guangzhou Center for Disease Control and Prevention, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Junmao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, China.'}]",PloS one,['10.1371/journal.pone.0235951']
3084,32678879,"CODEL: Phase III study of RT, RT + Temozolomide (TMZ), or TMZ for newly-diagnosed 1p/19q Codeleted Oligodendroglioma. Analysis from the initial study design.","BACKGROUND


We report the analysis involving patients treated on the initial CODEL design.
METHODS


Adults (>18) with newly-diagnosed 1p/19q WHO grade III oligodendroglioma were randomized to RT (5940 cGy) alone (Arm A); RT with concomitant and adjuvant temozolomide (TMZ) (Arm B); or TMZ alone (Arm C). Primary endpoint was overall survival (OS), Arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
RESULTS


Thirty-six patients were randomized equally. At median follow-up of 7.5 years, 83.3% (10/12) TMZ-alone patients progressed, versus 37.5% (9/24) on the RT arms. PFS was significantly shorter in TMZ-alone patients compared to RT-treated patients (HR=3.12; 95% CI: 1.26, 7.69; p=0.014). Death from disease progression occurred in 3/12 (25%) of TMZ-alone patients and 4/24 (16.7%) on the RT Arms. OS did not statistically differ between arms (comparison underpowered). After adjustment for IDH status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as co-variables (Arm C vs pooled Arms A+B), PFS remained shorter for patients not receiving RT, (HR= 3.33; 95% CI: 1.31, 8.45; p=0.011), but not OS ((HR = 2.78; 95% CI 0.58, 13.22, p=0.20). Grade 3+ adverse events occurred in 25%, 42% and 33% of patients (Arms A, B, and C). There were no differences between Arms in neurocognitive decline comparing baseline to 3 months.
CONCLUSIONS


TMZ-alone patients experienced significantly shorter PFS than patients treated on the RT Arms. The ongoing CODEL trial has been redesigned to compare RT+PCV versus RT+TMZ.",2020,"Arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
","['newly-diagnosed\xa01p/19q', 'Thirty-six patients', 'patients treated on\xa0the initial CODEL design', 'Adults (>18) with newly-diagnosed 1p/19q WHO grade III oligodendroglioma were randomized to RT (5940 cGy) alone (Arm A']","['TMZ', 'RT with concomitant and adjuvant temozolomide (TMZ) (Arm B); or TMZ', 'RT, RT + Temozolomide (TMZ), or TMZ', 'RT+PCV versus RT+TMZ']","['PFS', 'OS', 'Grade 3+ adverse events', 'OS and progression-free survival (PFS', 'neurocognitive decline', 'Death from disease progression', 'overall survival (OS']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0028945', 'cui_str': 'Oligodendroglioma, no ICD-O subtype'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",36.0,0.0848083,"Arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
","[{'ForeName': 'Kurt A', 'Initials': 'KA', 'LastName': 'Jaeckle', 'Affiliation': 'Department of Neurology, Mayo Clinic Florida, Jacksonville FL.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Alliance Statistics and Data Center, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van den Bent', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Center, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester MN.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester MN.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester MN.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester MN.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Cairncross', 'Affiliation': 'Department of Clinical Neurosciences, Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurologische Klinik, University of Heidelberg, Heidelberg Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Aldape', 'Affiliation': 'Department of Neuropathology, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jesse G', 'Initials': 'JG', 'LastName': 'Dixon', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Cerhan', 'Affiliation': 'Departments of Psychiatry and Psychology. , University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wefel', 'Affiliation': 'Departments of Neuro-Oncology and Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Medical Psychology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Grossman', 'Affiliation': 'Department of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Raizer', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Dhermain', 'Affiliation': 'Department of Radiation Therapy, Institut de Cancerologie Gustave Roussy, Villejuif France.'}, {'ForeName': 'Donald G', 'Initials': 'DG', 'LastName': 'Nordstrom', 'Affiliation': 'Medical Oncology, France Abben Cancer Center, Spencer, IA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'Medical Oncology, Minnesota Oncology, Northfield MN.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Dept. of Neurosurgery, Cleveland Clinic, Cleveland OH.'}]",Neuro-oncology,['10.1093/neuonc/noaa168']
3085,32679281,"China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial.","Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. METHODS AND RESULTS: The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. CONCLUSIONS: Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.",2020,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","['patients with Acute Myocardial Infarction (CTS-AMI', '3,796 eligible patients with STEMI from about 120 centers']","['Tongxinluo (TXL', 'TXL', 'TXL or placebo', 'placebo']","['each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters', '30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1742872', 'cui_str': 'tongxinluo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0948369', 'cui_str': 'Myocardial reinfarction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",3796.0,0.355531,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Dou', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qiuting', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guangyuan', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guihao', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ruijie', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingang', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Peking University Clinical Research Institute, Peking University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: yangyjfw@126.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.011']
3086,32679370,Early application of caffeine improves white matter development in very preterm infants.,"The aim of this study was to evaluate the effect of early prophylactic caffeine treatment on white matter development in very preterm infants using cerebral magnetic resonance imaging. A total of 194 preterm infants (≤32 weeks gestational age) were randomly assigned to the caffeine (n = 96) or placebo (n = 93) treatment group and administered with either caffeine or placebo within 72 hours after birth. Cerebral magnetic resonance imaging, including diffuse tensor imaging examination, was performed at 34-36 weeks of corrected gestational age, and the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were measured. In total, 160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group. There were fewer instances of apnea of prematurity and shorter assisted ventilation times for infants in the caffeine group compared to the placebo group (p <  0.05). Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group. ADC values in the above white matter areas were significantly reduced in the caffeine group. However, there were no significant differences regarding the FA and ADC in the gray matter between the two groups. These results demonstrate that early administration of caffeine improves white matter micro-structural development in preterm infants, but with no significant effect on short-term complications related to prematurity.",2020,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","['very preterm infants', 'very preterm infants using cerebral magnetic resonance imaging', 'preterm infants', '194 preterm infants (≤32 weeks gestational age', '160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group']","['placebo', 'caffeine', 'caffeine or placebo', 'prophylactic caffeine']","['white matter micro-structural development', 'apnea of prematurity and shorter assisted ventilation times', 'FA values', 'fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values', 'FA and ADC', 'ADC values']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",194.0,0.144528,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","[{'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Ruili', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Perinatal Medicine and Health, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden.'}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm 17177, Sweden. Electronic address: changlian.zhu@neuro.gu.se.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103495']
3087,32679400,Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study.,"OBJECTIVES


There is limited evidence available on the health-seeking behaviours of individuals in relation to determinants of healthcare use. This study aimed to analyse the determinants of healthcare use (including both hospital and outpatient services) among homeless people with severe mental health illnesses.
STUDY DESIGN


The study used data from a multicentre, randomised, controlled trial conducted in four large French cities (the French Housing First Study).
METHODS


Data were drawn from 671 homeless people enrolled in the study between August 2011 and April 2014. Mobile mental health outreach teams recruited homeless individuals with severe mental health illnesses who were living on the street or in emergency shelters, hospitals or prisons. Data collection was performed during face-to-face interviews. Healthcare service use included hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits to healthcare facilities or physicians' offices over a 6-month follow-up period. The data were analysed with zero-inflated (ZI) two-part models.
RESULTS


In total, 61.1% of participants had at least one hospitalisation stay over the previous 6 months, with a mean of 25 (+/- 39.2) hospital days, and the majority (51%) had visited the ED (either for regular or mental health issues) during the same time period. The results confirmed the role of financial barriers (resources and health insurance) in seeking hospital care (P < 0.05). The main predictors for hospital use in the study population were a better social functioning score (odds ratio [OR]: 1.03; P < 0.001) and having schizophrenia (OR: 1.39; P < 0.01). Higher mental health scores (assessed by the Medical Outcomes Study 36-item Short Form Health Survey) (OR: 1.03, P < 0.01) and alcohol dependence (OR: 2.13; P < 0.01) were associated with not using ED healthcare services. Being 'absolutely homeless' predicted an increased use of the ED and a zero use of outpatient services. Inversely, no association with factors related to the homelessness trajectory was found in hospital ZI negative binomial models.
CONCLUSION


This study is important because a comprehensive understanding of the determinants of healthcare use enables healthcare systems to adapt and develop. The efficiency of medicosocial interventions targeting the homeless population with mental health illnesses must also be assessed.
CLINICAL TRIAL NUMBER


NCT01570712.",2020,"Healthcare service use included hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits to healthcare facilities or physicians' offices over a 6-month follow-up period.","['homeless people with schizophrenia or bipolar disorder', 'Mobile mental health outreach teams recruited homeless individuals with severe mental health illnesses who were living on the street or in emergency shelters, hospitals or prisons', 'Data were drawn from 671 homeless people enrolled in the study between August 2011 and April 2014', 'four large French cities (the French Housing First Study', 'homeless people with severe mental health illnesses', 'homeless population with mental health illnesses']",['medicosocial interventions'],"['hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits', 'alcohol dependence ', 'social functioning score', 'hospitalisation stay', 'financial barriers (resources and health insurance', 'Higher mental health scores']","[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3178959', 'cui_str': 'Evacuation Shelter'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0642052,"Healthcare service use included hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits to healthcare facilities or physicians' offices over a 6-month follow-up period.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France. Electronic address: sandrine.loubiere@univ-amu.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Psychiatry, Sainte-Marguerite University Hospital, Marseille, 13009, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Taylor', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Loundou', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Girard', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boyer', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'Aix Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, 13005, France; Department of Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, Marseille, 13385, France.'}]",Public health,['10.1016/j.puhe.2020.05.019']
3088,32679403,"Commentary on Liu, K. et al. (2018). Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial.",,2020,,['patients with solid cancers'],['Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",[],,0.162369,,"[{'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China. Electronic address: yanpingying0116@126.com.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103691']
3089,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
3090,32681547,Effect of a high protein/low glycaemic index diet on insulin resistance in adolescents with overweight/obesity-A PREVIEW randomized clinical trial.,"BACKGROUND


Pubertal insulin resistance (IR) is associated with increased risk of type 2 diabetes mellitus development in adolescents with overweight/obesity.
OBJECTIVES


The PREVIEW study was a randomized parallel trial assessing the change in IR, analyzed by Homeostatic Model Assessment of IR (HOMA-IR), at 2 years after randomization to a high protein vs a moderate protein diet in adolescents with overweight/obesity. It was hypothesized that a high protein/low glycaemic index diet would be superior in reducing IR compared to a medium protein/medium GI diet, in insulin resistant adolescents with overweight or obesity.
METHODS


Adolescents with overweight/obesity and IR from the Netherlands, United Kingdom and Spain were randomized into a moderate protein/moderate GI (15/55/30En% protein/carbohydrate/fat, GI ≥ 56) or high protein/low GI (25/45/30En% protein/carbohydrate/fat, GI < 50) diet. Anthropometric and cardiometabolic parameters, puberty, dietary intake and physical activity (PA) were measured and effects on HOMA-IR were analyzed.
RESULTS


126 adolescents were included in this study (13.6 ± 2.2 years, BMI z-score 3.04 ± 0.66, HOMA-IR 3.48 ± 2.28, HP n = 68, MP n = 58). At 2 years, changes in protein intake were not significantly different between timepoints or intervention groups and no effects of the intervention on IR were observed. The retention rate was 39%, while no compliance to the diets was observed.
CONCLUSIONS


The PREVIEW study observed no effect of a high protein/low GI diet on IR in adolescents with overweight/obesity and IR because of lack of feasibility, due to insufficient retention and dietary compliance after 2 years.",2020,"At 2 years, changes in protein intake were not significantly different between timepoints or intervention groups and no effects of the intervention on IR were observed.","['adolescents with overweight/obesity', '126 adolescents were included in this study (13.6\u2009±\u20092.2\u2009years, BMI z-score 3.04\u2009±\u20090.66, HOMA-IR 3.48\u2009±\u20092.28, HP n = 68, MP n = 58', 'Adolescents with overweight/obesity and IR from the Netherlands, United Kingdom and Spain']","['high protein/low GI diet', 'high protein vs a moderate protein diet', 'high protein/low glycaemic index diet', 'moderate protein/moderate GI (15/55/30En% protein/carbohydrate/fat, GI\u2009≥\u200956) or high protein/low GI (25/45/30En% protein/carbohydrate/fat, GI\u2009<\u200950) diet']","['HOMA-IR', 'insulin resistance', 'changes in protein intake', 'Anthropometric and cardiometabolic parameters, puberty, dietary intake and physical activity (PA', 'retention rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0452269', 'cui_str': 'Protein diet'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",126.0,0.0139449,"At 2 years, changes in protein intake were not significantly different between timepoints or intervention groups and no effects of the intervention on IR were observed.","[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Dorenbos', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Drummen', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Adam', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Rijks', 'Affiliation': ""Centre for Overweight Adolescent and Children's Healthcare (COACH), Maastricht University Medical Centre, Maastricht, The Netherlands.""}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Department of Nutrition, Food Science and Physiology, Centre for Nutrition Research (CIN), Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navas-Carretero', 'Affiliation': 'Department of Nutrition, Food Science and Physiology, Centre for Nutrition Research (CIN), Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Swindell', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Stouthart', 'Affiliation': ""Centre for Overweight Adolescent and Children's Healthcare (COACH), Maastricht University Medical Centre, Maastricht, The Netherlands.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mackintosh', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Melitta', 'Initials': 'M', 'LastName': 'Mcnarry', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Department of Kinesiology, Université Laval, Québec, Canada.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Vreugdenhil', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}]",Pediatric obesity,['10.1111/ijpo.12702']
3091,32681596,Caffeine Increases Strength and Power Performance in Resistance-trained Females During Early Follicular Phase.,"The effects of 4 mg·kg -1  caffeine ingestion on strength and power were investigated for the first time, in resistance-trained females during the early follicular phase utilizing a randomized, double-blind, placebo-controlled, crossover design. Fifteen females (29.8±4.0 years, 63.8±5.5 kg [mean±SD]) ingested caffeine or placebo 60 minutes before completing a test battery separated by 72 hours. One-repetition maximum (1RM), repetitions to failure (RTF) at 60% of 1RM, were assessed in the squat and bench press. Maximal voluntary contraction torque (MVC) and rate of force development (RFD) were measured during isometric knee-extensions, while utilizing interpolated twitch technique to measure voluntary muscle activation. Maximal power and jump height were assessed during countermovement jumps (CMJ). Caffeine metabolites were measured in plasma. Adverse effects were registered after each trial. Caffeine significantly improved squat (4.5±1.9%, effect size [ES]: 0.25) and bench press 1RM (3.3±1.4%, ES: 0.20), and squat (15.9±17.9%, ES: 0.31) and bench press RTF (9.8±13.6%, ES: 0.31), compared to placebo. MVC torque (4.6±7.3%, ES: 0.26), CMJ height (7.6±4.0%, ES: 0.50) and power (3.8±2.2%, ES: 0.24) were also significantly increased with caffeine. There were no differences in RFD or muscle activation. Plasma [caffeine] was significantly increased throughout the protocol and mild side-effects of caffeine were experienced by only 3 participants. This study demonstrated that 4 mg·kg -1  caffeine ingestion enhanced maximal strength, power and muscular endurance in resistance-trained and caffeine-habituated females during the early follicular phase, with few adverse effects. Female strength and power athletes may consider using this dose pre-competition and -training as an effective ergogenic aid.",2020,"Caffeine significantly improved squat (4.5±1.9%, effect size [ES]: 0.25) and bench press 1RM (3.3±1.4%, ES: 0.20), and squat (15.9±17.9%, ES: 0.31) and bench press RTF (9.8±13.6%, ES: 0.31), compared to placebo.","['Fifteen females (29.8±4.0 years, 63.8±5.5 kg [mean±SD]) ingested', 'resistance-trained females during the early follicular phase utilizing', 'Resistance-trained Females During Early Follicular Phase']","['4 mg·kg -1  caffeine ingestion', 'caffeine', 'Caffeine', 'caffeine or placebo', 'placebo']","['Plasma [caffeine', 'Caffeine Increases Strength and Power Performance', 'CMJ height', 'Caffeine metabolites', 'maximal strength, power and muscular endurance', 'One-repetition maximum (1RM), repetitions to failure (RTF', 'Maximal power and jump height', 'Adverse effects', 'Maximal voluntary contraction torque (MVC) and rate of force development (RFD', 'MVC torque', 'RFD or muscle activation', 'squat']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0861097', 'cui_str': 'Caffeine increased'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",,0.187158,"Caffeine significantly improved squat (4.5±1.9%, effect size [ES]: 0.25) and bench press 1RM (3.3±1.4%, ES: 0.20), and squat (15.9±17.9%, ES: 0.31) and bench press RTF (9.8±13.6%, ES: 0.31), compared to placebo.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Norum', 'Affiliation': 'School of Science and Technology, London Sport Institute, Middlesex University, London, United Kingdom.'}, {'ForeName': 'Linn Christin', 'Initials': 'LC', 'LastName': 'Risvang', 'Affiliation': 'School of Science and Technology, London Sport Institute, Middlesex University, London, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bjørnsen', 'Affiliation': 'Department of Sport Science and Physical Education, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Lygeri', 'Initials': 'L', 'LastName': 'Dimitriou', 'Affiliation': 'School of Science and Technology, London Sport Institute, Middlesex University, London, United Kingdom.'}, {'ForeName': 'Per Ola', 'Initials': 'PO', 'LastName': 'Rønning', 'Affiliation': 'Department of Mechanical, Electronics and Chemical Engineering, Faculty of Technology, Art and Design, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bjørgen', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13776']
3092,32681665,"Effects of velocity loss in the bench press exercise on strength gains, neuromuscular adaptations and muscle hypertrophy.","OBJECTIVE


This study aimed to compare the effects of four velocity-based training (VBT) programs in bench-press (BP) between a wide range of velocity loss (VL) thresholds - 0% (VL0), 15% (VL15), 25% (VL25) and 50% (VL50) - on strength gains, neuromuscular adaptations and muscle hypertrophy.
METHODS


Sixty-four resistance-trained young men were randomly assigned into four groups (VL0, VL15, VL25, and VL50) that differed in the VL allowed in each set. Subjects followed a VBT program for 8-weeks using the BP exercise. Before and after the VBT program the following tests were performed: 1) cross-sectional area (CSA) measurements of pectoralis major (PM) muscle; 2) maximal isometric test; 3) progressive loading test; and 4) fatigue test.
RESULTS


Significant group x time interactions were observed for CSA (P<0.01) and peak root mean square in PM (peak RMS-PM, P<0.05). VL50 showed significantly greater gains in CSA than VL0 (P<0.05). Only the VL15 group showed significant increases in peak RMS-PM (P<0.01). Moreover, only VL0 showed significant gains in the early rate of force development (RFD, P=0.05), while VL25 and VL50 improved in the late RFD (P≤0.01-0.05). No significant group × time interactions were found for any of the dynamic strength variables analyzed, although all groups showed significant improvements in all these parameters.
CONCLUSION


Higher VL thresholds allowed for a greater volume load which maximized muscle hypertrophy, whereas lower VL thresholds evoked positive neuromuscular-related adaptations. No significant differences were found between groups for strength gains, despite the wide differences in the total volume accumulated by each group.",2020,"No significant group × time interactions were found for any of the dynamic strength variables analyzed, although all groups showed significant improvements in all these parameters.
",['Sixty-four resistance-trained young men'],"['VBT program', 'four velocity-based training (VBT) programs']","['CSA (P<0.01) and peak root mean square in PM', 'early rate of force development (RFD, P=0.05), while VL25 and VL50', 'strength gains', '1) cross-sectional area (CSA) measurements of pectoralis major (PM) muscle; 2) maximal isometric test; 3) progressive loading test; and 4) fatigue test', 'time interactions', 'peak RMS-PM', 'strength gains, neuromuscular adaptations and muscle hypertrophy']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}]",64.0,0.0210054,"No significant group × time interactions were found for any of the dynamic strength variables analyzed, although all groups showed significant improvements in all these parameters.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': 'Physical Performance & Sports Research Center, Department of Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alcazar', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Cornejo-Daza', 'Affiliation': 'Physical Performance & Sports Research Center, Department of Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sánchez-Valdepeñas', 'Affiliation': 'Physical Performance & Sports Research Center, Department of Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rodriguez-Lopez', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hidalgo-de Mora', 'Affiliation': 'Physical Performance & Sports Research Center, Department of Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sánchez-Moreno', 'Affiliation': 'Department of Physical Education and Sports, University of Seville, Seville, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bachero-Mena', 'Affiliation': 'Department of Physical Education and Sports, University of Seville, Seville, Spain.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Alegre', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ortega-Becerra', 'Affiliation': 'Physical Performance & Sports Research Center, Department of Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, Spain.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13775']
3093,32602596,To punish or to assist? Divergent reactions to ingroup and outgroup members disobeying social distancing.,"In response to the COVID-19 pandemic, societies face the formidable challenge of developing sustainable forms of sociability-cumsocial-distancing - enduring social life while containing the virus and preventing new outbreaks. Accordant public policies often balance between retributive (punishment-based) and assistance (solidarity-based) measures to foster responsible behaviour. Yet, the uncontrolled spreading of the disease has divided public opinion about which measures are best suited, and it has made salient group disparities in behaviour, potentially straining intergroup relations, elevating heated emotions, and undercutting coordinated international responses. In a 2 × 2 between-subjects experiment, British citizens (N = 377) read about national in-group or outgroup members (categorical differentiation), who were either conforming to or deviating from the corona regulations (normative differentiation). Participants then reported moral emotions towards the target national group and indicated support for public policies. In general, support for assistance policies outweighed support for retributive measures. Second, however, norm deviation was associated with less positive and more negative moral emotions, the latter category further relating to more punitiveness and less assistance support. Finally, respondents who read about norm-violating outgroup members especially reported support for retributive measures, indicating that people might use norm deviation to justify outgroup derogation. We discuss implications for policymakers and formulate future research avenues.",2020,"In response to the COVID-19 pandemic, societies face the formidable challenge of developing sustainable forms of sociability-cumsocial-distancing - enduring social life while containing the virus and preventing new outbreaks.","['In a 2\xa0×\xa02 between-subjects experiment, British citizens (N\xa0=\xa0377) read about national in-group or outgroup members (categorical differentiation), who were either conforming to or deviating from the corona regulations (normative differentiation']",[],"['moral emotions', 'negative moral emotions']","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",[],"[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",377.0,0.0153191,"In response to the COVID-19 pandemic, societies face the formidable challenge of developing sustainable forms of sociability-cumsocial-distancing - enduring social life while containing the virus and preventing new outbreaks.","[{'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Van Assche', 'Affiliation': 'Department of Developmental, Personality and Social Psychology, Ghent University, Belgium.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Politi', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Center for Social and Cultural Psychology, University of Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Van Dessel', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Phalet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Center for Social and Cultural Psychology, University of Leuven, Belgium.'}]",The British journal of social psychology,['10.1111/bjso.12395']
3094,32681775,Self-estimation of phenylketonuria patients on therapeutic diet. Psychological support.,"Objectives Self-esteem is the degree to which the qualities and characteristics contained in one's self-concept are perceived to be positive. The aim of this study was to evaluate the self-esteem scores in phenylketonuria (PKU) patients on ""strict"", ""loos"" and ""off diet"". Sixty PKU patients were divided in three equal groups. Methods Group a: ""on strict"", group b: ""on loos"" and group c: ""off diet"". A special questionnaire for self-esteem scores was created for these patients. Results Before psychological support, group a patients demonstrated 6/20 (30%) very high self-esteem, 9/20 (45%) high and 5/25 (25%) moderate. After support 14/20 (70%) were turned to very high, 5/20 (25%) represented high except one whose degrees remained an altered. group b 4/20 (20%) were very high, 7/20 (35%) were high, 3/20 (15%) moderate and the rest of them showed low self-esteem degrees, after support, 10/20 (50%) showed very high, 5/20 (25%) became high, 3/20 (15%) turned to moderate and 2/20 (10%) remained unaltered. Group c, 1/20 (5%) were very high self-esteemed, 7/20 (35%) were high, 6/20 (30%) were moderate and 6/20 (30%) with low self-esteemed, at the end of support, 6/20 (30%) become very high, 8/20 (40%) with high, 4/20 (20.0%), moderate self-esteem whereas the rest were unaltered. Conclusions Very high and high self-esteem degrees were demonstrated in patients who follow their PKU diet. Moderate and low self-esteem degrees were predominantly found in patients on loos and or off diet. Psychological supports commonly result in amelioration of self-esteem degrees.",2020,Results Before psychological support,"['Sixty PKU patients', 'phenylketonuria (PKU) patients on ""strict"", ""loos"" and ""off diet']","['on loos"" and group c: ""off diet']","['high self-esteem', 'Moderate and low self-esteem degrees', 'moderate self-esteem', 'self-esteem scores']","[{'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C2712312', 'cui_str': 'High self-esteem'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0184039,Results Before psychological support,"[{'ForeName': 'Kostas Konstantinos', 'Initials': 'KK', 'LastName': 'Iakovou', 'Affiliation': 'Institute of child health, Inborn Errors of Metabolism, Hivon & Papadiamantopoulou, 15773, Αthens, 11527, Attiki, Greece.'}, {'ForeName': 'Kleopatra', 'Initials': 'K', 'LastName': 'Schulpis', 'Affiliation': 'Institute of Child Health Athens, Inborn error of metabolism, Athens, Attiki, Greece.'}]",Drug metabolism and personalized therapy,['10.1515/dmpt-2020-0107']
3095,32681816,"Novel approaches to behavioral management of vasovagal reactions and donor recruitment: comment on ""a randomized controlled trial of a table-based intervention to address predonation fears among high school donors"".",,2020,,['high school donors'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]",[],[],,0.0449032,,"[{'ForeName': 'Blaine', 'Initials': 'B', 'LastName': 'Ditto', 'Affiliation': 'Department of Psychology, McGill University, Montreal, Québec, Canada.'}]",Transfusion,['10.1111/trf.15950']
3096,32681922,Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome with Predominant Abdominal Bloating: Short- and Long-Term Results from a Placebo-Controlled Randomized Trial.,"BACKGROUND & AIMS


Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder associated with intestinal dysbiosis. Given reported promising results of open-label fecal microbiota transplantation (FMT) therapy in patients with predominant abdominal bloating, we studied efficacy of this treatment in a randomized, placebo-controlled trial.
METHODS


Patients with refractory IBS, defined as failure of ≥ 3 conventional therapies, were randomly assigned to single-dose nasojejunal administration of donor stools (n=43) or autologous stools (n=19) in a double-blind study, performed from December 2015 through October 2017, and followed for 1 year. IBS-related symptoms were assessed using a daily symptom diary to determine general abdominal discomfort, abdominal bloating, abdominal pain and flatulence on a scale of 1-6. Number of daily bowel movements, consistency of the stools, and the abdominal circumference were also recorded. Patients completed the IBS-specific quality of life questionnaire. Primary endpoints were improvement of IBS symptoms and bloating at 12 weeks (response). Secondary endpoints were changes in IBS-symptom-scores and quality of life. Stool samples were collected for microbiota amplicon sequencing. Open-label re-transplantation was offered after the trial.
RESULTS


At week 12, 56% of patients given donor stool reported improvement in both primary endpoints compared with 26% of patients given placebo (P=.03). Patients given donor stool had significant improvements in level of discomfort (mean reduction of 19%; median score preFMT, 3.98; range, 2.13-6.00; median score post-FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction of 13%, median score preFMT, 2.10; range, 0.57-14.29; median score postFMT 1.7; range, 0.71-4.29), urgency (mean reduction of 38%; median score preFMT, 0.61; range, 0.00-1.00; median score postFMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction of 26%; median score preFMT, 3.88; range, 1.57-5.17; median score postFMT, 2.80; range, 1.14-4.94), flatulence (mean reduction of 10%; median score preFMT, 3.42; range, 0.71-6.00; median score postFMT, 3.07; range, 0.79-4.23), and quality of life (mean increase of 16%; median score preFMT 32.6; range, 11-119; median score postFMT, 43.1; range, 32.25-99). A significantly higher proportion of women given donor stool (69%) had a response than men (29%) (P=.01). Fecal samples from responders had higher diversity of microbiomes before administration of donor material than fecal samples from non-responders (P=.04) and distinct baseline composition (P= .04), but no specific marker taxa were associated with response. After single FMT, 21% of patients given donor stool reported effects that lasted for more than 1 year, compared with 5% of patients given placebo stool. A second FMT reduced symptoms in 67% of patients with an initial response to donor stool, but not in patients with a prior non-response.
CONCLUSIONS


In a randomized trial of patients with treatment-refractory IBS with predominant bloating, FMT relieved symptoms compared with placebo (autologous transplant), although effects decreased over 1 year. A second FMT restored the response patients with a prior response. Response associated with composition of the fecal microbiomes before FMT; this might be used to as a biomarker to select patients for this treatment. ClinicalTrials.gov no: NCT02299973.",2020,"Patients given donor stool had significant improvements in level of discomfort (mean reduction of 19%; median score preFMT, 3.98; range, 2.13-6.00; median score post-FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction of 13%, median score preFMT, 2.10; range, 0.57-14.29; median score postFMT 1.7; range, 0.71-4.29), urgency (mean reduction of 38%; median score preFMT, 0.61; range, 0.00-1.00; median score postFMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction of 26%; median score preFMT, 3.88; range, 1.57-5.17; median score postFMT, 2.80; range, 1.14-4.94), flatulence (mean reduction of 10%; median score preFMT, 3.42; range, 0.71-6.00; median score postFMT, 3.07; range, 0.79-4.23), and quality of life (mean increase of 16%; median score preFMT 32.6; range, 11-119; median score postFMT, 43.1; range, 32.25-99).","['patients with treatment-refractory IBS with predominant bloating, FMT relieved symptoms compared with', 'Irritable Bowel Syndrome with Predominant Abdominal Bloating', 'Patients with refractory IBS, defined as failure of ≥ 3 conventional therapies', 'patients with predominant abdominal bloating']","['open-label fecal microbiota transplantation (FMT) therapy', 'single-dose nasojejunal administration of donor stools (n=43) or autologous stools', 'Placebo', 'placebo (autologous transplant', 'Fecal Microbiota Transplantation', 'placebo']","['quality of life', 'IBS symptoms and bloating', 'Number of daily bowel movements, consistency of the stools, and the abdominal circumference', 'level of discomfort', 'stool frequency', 'IBS-specific quality of life questionnaire', 'urgency', 'general abdominal discomfort, abdominal bloating, abdominal pain and flatulence', 'flatulence', 'abdominal pain', 'changes in IBS-symptom-scores and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.524345,"Patients given donor stool had significant improvements in level of discomfort (mean reduction of 19%; median score preFMT, 3.98; range, 2.13-6.00; median score post-FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction of 13%, median score preFMT, 2.10; range, 0.57-14.29; median score postFMT 1.7; range, 0.71-4.29), urgency (mean reduction of 38%; median score preFMT, 0.61; range, 0.00-1.00; median score postFMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction of 26%; median score preFMT, 3.88; range, 1.57-5.17; median score postFMT, 2.80; range, 1.14-4.94), flatulence (mean reduction of 10%; median score preFMT, 3.42; range, 0.71-6.00; median score postFMT, 3.07; range, 0.79-4.23), and quality of life (mean increase of 16%; median score preFMT 32.6; range, 11-119; median score postFMT, 43.1; range, 32.25-99).","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Holvoet', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium; Faculty of Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Joossens', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and Transplantation, Rega Institute, Leuven, Belgium; VIB, Center for Microbiology, Leuven, Belgium.'}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Vázquez-Castellanos', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and Transplantation, Rega Institute, Leuven, Belgium; VIB, Center for Microbiology, Leuven, Belgium.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Christiaens', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Lander', 'Initials': 'L', 'LastName': 'Heyerick', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jerina', 'Initials': 'J', 'LastName': 'Boelens', 'Affiliation': 'Department of Medical Microbiology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Verhasselt', 'Affiliation': 'Department of Medical Microbiology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Vlierberghe', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'De Vos', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and Transplantation, Rega Institute, Leuven, Belgium; VIB, Center for Microbiology, Leuven, Belgium.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'De Looze', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium; Faculty of Health Sciences, Ghent University, Ghent, Belgium.'}]",Gastroenterology,['10.1053/j.gastro.2020.07.013']
3097,32681995,Randomized study comparing a reusable morcellator to a resectoscope in the hysteroscopic treatment of uterine polyps: The RESMO study.,"STUDY OBJECTIVE


To compare a reusable hysteroscopic morcellator and standard resectoscopes in the hysteroscopic management of uterine polyps.
DESIGN


Single-center randomized prospective single-blind trial (RESMO Study).
SETTING


CMCO teaching hospital, Strasbourg University Hospitals, France PATIENTS: All patients presenting a single endometrial polyp of size greater than or equal to a centimeter.
INTERVENTIONS


After consent, patients were randomized into two groups: hysteroscopic morcellator (HM) or standard resection group (SR). Office-based review hysteroscopy was performed 6 to 8 weeks after surgery. Primary endpoint: time of morcellation or resection.
SECONDARY OUTCOMES


total operating time (min), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (Visual Analogic Scale VAS: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (VAS), and length of hospitalization. At review hysteroscopy, we noted whether resection or morcellation had been effective and if synechiae were present or absent. Statistical analyses followed Bayesian methods.
MEASUREMENTS AND MAIN RESULTS


Ninety patients were randomized, 45 in the HM group and 45 in the SR group. The average size of polyps at hysteroscopy was 13.3 mm. Morcellation time was lower than resection time [6.1 vs 9 min; P (HM<SR) = 0.996]. This also applied for total operating time [12.7 vs 15.6 min; P (HM<SR) = 0.985], number of device insertions [1.50 vs 6; P (HM<SR) = 1], volume of fluid used [766.9 vs 1118.9 mL; P (HM<SR) = 0.994], and fluid deficit [60.2 vs 169.8 mL; P (HM<SR) = 0.989]. Operator comfort was better in the morcellator group [8.4 vs 7.4; P (HM>SR) = 0.999] as was visualization [4 vs 3.7; P (HM>SR) = 0.911, highly probable]. Operative complications were higher in the SR group [5 vs 0; P(HM<SR)=0.989]. One patient in the SR group unfortunately died after surgery due to an anesthetic complication (anaphylactic shock complicated by pulmonary embolism). No differences were noted between groups for pain assessment, length of hospitalization and outcome on review hysteroscopy.
CONCLUSION


The reusable morcellator is quicker, uses less fluid with less deficit and fewer introductory maneuvers, and offers better comfort and visualization than the resectoscope while being as effective for the hysteroscopic treatment of uterine polyps.",2020,Operative complications were higher in the SR group [5 vs 0; P(HM<SR)=0.989].,"['Ninety patients were randomized, 45 in the HM group and 45 in the SR group', 'All patients presenting a single endometrial polyp of size greater than or equal to a centimeter', 'CMCO teaching hospital, Strasbourg University Hospitals', 'uterine polyps']","['hysteroscopic morcellator (HM) or standard resection group (SR', 'reusable hysteroscopic morcellator and standard resectoscopes', 'reusable morcellator to a resectoscope']","['volume of fluid', 'time of morcellation or resection', 'Morcellation time', 'Operative complications', 'Operator comfort', 'pain assessment, length of hospitalization and outcome on review hysteroscopy', 'number of device insertions', 'average size of polyps at hysteroscopy', 'fluid deficit', 'total operating time (min), volume of fluid used (mL), fluid deficit (mL), number of morcellator or resectoscope insertions, operator comfort (Visual Analogic Scale VAS: 0 to 10) and quality of vision (0 to 5), perioperative complications, completeness of resection, need to convert to another technique, pain assessment (VAS), and length of hospitalization', 'total operating time']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0156369', 'cui_str': 'Polyp of corpus uteri'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",90.0,0.0507971,Operative complications were higher in the SR group [5 vs 0; P(HM<SR)=0.989].,"[{'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Stoll', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France. Electronic address: francois.stoll@gmail.com.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Lecointre', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Medical Information Department, Hôpitaux Universitaires de Strasbourg, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Faller', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Host', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hummel', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boisrame', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France.'}, {'ForeName': 'Cherif', 'Initials': 'C', 'LastName': 'Akladios', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Garbin', 'Affiliation': 'Department of Obstetrics and Gynecology, Hôpitaux Universitaires de Strasbourg, France.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.07.007']
3098,32681996,Auto-Cross-Linked Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions after Hysteroscopic Adhesiolysis: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To investigate auto-cross-linked hyaluronic acid gel for prevention of intrauterine adhesion (IUA) recurrence after hysteroscopic adhesiolysis.
DESIGN


A single-center, double blind, randomized controlled trial.
SETTING


A tertiary university hospital.
PATIENTS


272 patients with moderate to severe (American Fertility Society score ≥5) IUAs underwent hysteroscopic adhesiolysis.
INTERVENTIONS


Patients were randomized to receive standard care along with auto-cross-linked hyaluronic acid gel following surgery (treatment group) or standard care only (control group). All patients had second-look hysteroscopy at 4 weeks and hormonal therapy for 2 cycles after surgery.
MEASUREMENTS AND MAIN RESULTS


260 patients were eligible and randomized while 245 patients successfully completed the study (n = 122 in treatment group; n = 123 in control group). Primary outcome measure was IUA recurrence at second-look hysteroscopy. Secondary outcome measures included improvement in American Fertility Society score and menstrual pattern. There was no significant difference with regard to IUA recurrence (31.1% vs 39.8%) or median American Fertility Society score at second-look hysteroscopy (2, interquartile range [2-4] vs 2, interquartile range [2-4]) or improvement in menstrual pattern at 3-months follow-up (87.7% vs 76.4%), in treatment and control groups, respectively.
CONCLUSION


The application of auto-cross-linked hyaluronic acid gel did not appear to improve IUA recurrence following hysteroscopic adhesiolysis.",2020,The application of auto-cross-linked hyaluronic acid gel did not appear to improve IUA recurrence following hysteroscopic adhesiolysis.,"['272 patients with moderate to severe (American Fertility Society score ≥5', 'A tertiary university hospital', 'Intrauterine Adhesions after Hysteroscopic Adhesiolysis', '260 patients were eligible and randomized while 245 patients successfully completed the study (n\u202f=\u202f122 in treatment group; n\u202f=\u202f123 in control group']","['Auto-Cross-Linked Hyaluronic Acid Gel', 'hyaluronic acid gel', 'hormonal therapy', 'standard care along with auto-cross-linked hyaluronic acid gel following surgery (treatment group) or standard care only (control group']","['IUA recurrence at second-look hysteroscopy', 'IUA recurrence', 'American Fertility Society score and menstrual pattern', 'intrauterine adhesion (IUA) recurrence', 'median American Fertility Society score', 'menstrual pattern']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0949626', 'cui_str': 'Incision and reexploration for second look'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",272.0,0.36468,The application of auto-cross-linked hyaluronic acid gel did not appear to improve IUA recurrence following hysteroscopic adhesiolysis.,"[{'ForeName': 'Qiaoyun', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Hysteroscopic Center, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Hysteroscopic Center, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China; Assisted Reproductive Technology Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Saravelos', 'Affiliation': 'Assisted Reproductive Technology Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR; IVF Unit, Hammersmith Hospital, Imperial College, London, UK.'}, {'ForeName': 'Xiaowu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Hysteroscopic Center, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Hysteroscopic Center, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Department of Hysteroscopic Center, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China.'}, {'ForeName': 'Enlan', 'Initials': 'E', 'LastName': 'Xia', 'Affiliation': 'Department of Hysteroscopic Center, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tin Chiu', 'Initials': 'TC', 'LastName': 'Li', 'Affiliation': 'Department of Hysteroscopic Center, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China; Assisted Reproductive Technology Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR. Electronic address: tinchiu.li@gmail.com.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.06.030']
3099,32682049,"Employee perseverance in a ""no phone use while driving"" organizational road-safety intervention.","INTRODUCTION


This interdisciplinary study explores factors that contribute to the perseverance of participants in an organizational ""no phone use while driving"" road-safety intervention.
METHOD


The study sample comprised 200 employees (mean age 43 years; 104 females [52 %], 96 males [48 %]) from 8 organizations in Israel. Subjects completed a 4-month organizational intervention using a smartphone application that monitored smartphone use, operationalized as taps per minute, where each tap represents a single instance of contact with the screen (e.g., touching, tapping or swiping). The app also silenced notifications during the intervention stage. Changes over time in tapping-while-driving behavior were examined through self-report questionnaires and objectively through the application's monitoring function. Validated measures were used to examine factors associated with perseverance in the program.
RESULTS


Organizational safety climate and gender (male) were positively related to perseverance in the intervention. Contrary to our hypothesis, safety motivation was not found to influence perseverance.
CONCLUSIONS


The present intervention is most effective for employees with high safety climate perceptions and for male employees.
PRACTICAL APPLICATIONS


The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving. Our findings show that people will download and use an app that actively reduces their incentive to use their phones at the wheel by silencing incoming notifications. The findings support calls to harness the positive potential of information and communications technologies for organizational interventions.",2020,"The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving.","['employees with high safety climate perceptions and for male employees', '200 employees (mean age 43 years; 104 females [52 %], 96 males [48 %]) from 8 organizations in Israel']",[],['safety motivation'],"[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",200.0,0.0146053,"The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Rispler', 'Affiliation': 'Faculty of Welfare and Health Sciences, Department of Human Services, University of Haifa, Mount Carmel, Haifa, 31905, Israel. Electronic address: clararispler5510@gmail.com.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Luria', 'Affiliation': 'Faculty of Welfare and Health Sciences, Department of Human Services, University of Haifa, Mount Carmel, Haifa, 31905, Israel. Electronic address: gluria@univ.haifa.ac.il.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105689']
3100,32678677,"Curcumagalactomannoside/Glucosamine Combination Improved Joint Health Among Osteoarthritic Subjects as Compared to Chondroitin Sulfate/Glucosamine: Double-Blinded, Randomized Controlled Study.","Objective:  A combination of curcumagalactomannosides (CGM) (400 mg) with glucosamine hydrochloride (GLN) (500 mg) was evaluated against a standard dietary supplement combination chondroitin sulfate (CHN) (415 mg)/GLN (500 mg) for their effectiveness in alleviating the pain and symptoms among osteoarthritic subjects.  Design:  Randomized, double-blinded and active-controlled study.  Settings/Location:  The study was conducted in a hospital-based research center in Vadodara, Gujarat, India.  Subjects:  Eighty subjects (38 males and 42 females), with confirmed osteoarthritis (OA) (Class I-III), were randomized into two parallel groups designated as Group I (CGM-GLN) and Group II (CHN-GLN).  Interventions:  All the study subjects were supplemented with their corresponding intervention capsules (ether CGM along with GLN or CHN along with GLN), as a single oral dose twice a day, once in the morning 10-15 min before breakfast and again in the evening before dinner, for 84 days.  Outcome measures:  A validated treadmill uphill walking protocol was used for the study, and the efficiency of supplementation was evaluated using visual analogue scale (VAS) score, Karnofsky Performance Scale (KPS) score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the baseline, 28th, and 84th day following the treatment. Mechanism of action of CGM-GLN combination was analyzed by measuring the levels of serum inflammatory markers interleukin 1 beta (IL-1β), interleukin 6 (IL-6), and soluble vascular cell adhesion molecule-1 (sVCAM) at the baseline and 84th day.  Results:  CGM-GLN was found to offer significant beneficial effects to pain, stiffness, and physical function of OA subjects compared with CHN-GLN, which was evident from the improvement in walking performance, VAS score, KPS score, and WOMAC score. The efficiency of CGM-GLN was almost double compared with the CHN-GLN by the end of the study (84th day). A significant reduction of inflammatory serum marker levels was observed among CGM-GLN subjects compared with CHN-GLN subjects. Compared with the baseline, CGM-GLN produced 54.52%, 59.08%, and 22.03% reduction in IL-1β, IL-6, and sVCAM levels, respectively. Whereas CHN-GLN group of subjects expressed only 23.17%, 21.38%, and 6.82% reduction in IL-1β, IL-6, and sVCAM levels, respectively.  Conclusions:  In conclusion, the present study demonstrated the potential benefits of CGM-GLN supplements in alleviating the symptoms and function of OA subjects compared with the standard CHN-GLN treatment. The augmented efficacy of CGM-GLN combination could be attributed to the enhanced anti-inflammatory effect of CGM.",2020,A significant reduction of inflammatory serum marker levels was observed among CGM-GLN subjects compared with CHN-GLN subjects.,"['hospital-based research center in Vadodara, Gujarat, India', 'osteoarthritic subjects', 'Subjects:  Eighty subjects (38 males and 42 females), with confirmed osteoarthritis (OA) (Class I-III']","['glucosamine hydrochloride (GLN', 'Curcumagalactomannoside/Glucosamine', 'CHN-GLN', 'CGM-GLN', 'Chondroitin Sulfate/Glucosamine', 'standard dietary supplement combination chondroitin sulfate (CHN', 'Group I (CGM-GLN) and Group II (CHN-GLN', 'curcumagalactomannosides (CGM', 'CGM-GLN supplements', 'corresponding intervention capsules (ether CGM along with GLN or CHN along with GLN']","['efficiency of CGM-GLN', 'levels of serum inflammatory markers interleukin 1 beta (IL-1β), interleukin 6 (IL-6), and soluble vascular cell adhesion molecule-1 (sVCAM', 'efficiency of supplementation was evaluated using visual analogue scale (VAS) score, Karnofsky Performance Scale (KPS) score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire', 'IL-1β, IL-6, and sVCAM levels', 'pain, stiffness, and physical function', 'Joint Health', 'pain and symptoms', 'inflammatory serum marker levels', 'walking performance, VAS score, KPS score, and WOMAC score']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0771903', 'cui_str': 'Glucosamine hydrochloride'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2929470', 'cui_str': 'Chondroitin Sulfates / Glucosamine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0014994', 'cui_str': 'ethyl ether'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0878425,A significant reduction of inflammatory serum marker levels was observed among CGM-GLN subjects compared with CHN-GLN subjects.,"[{'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'Aman Hospital and Research Center, Vadodara, India.'}, {'ForeName': 'Sivadasan Syam', 'Initials': 'SS', 'LastName': 'Das', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Thozhuthum Parambil', 'Initials': 'TP', 'LastName': 'Smina', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Jestin V', 'Initials': 'JV', 'LastName': 'Thomas', 'Affiliation': 'Leads Clinical Research & Bio Services Pvt. Ltd., Bangalore, India.'}, {'ForeName': 'Ajaikumar B', 'Initials': 'AB', 'LastName': 'Kunnumakkara', 'Affiliation': 'Department of Biosciences and Bioengineering, Indian Institute of Technology Guwahati, India.'}, {'ForeName': 'Balu', 'Initials': 'B', 'LastName': 'Maliakel', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Illathu Madhavamenon', 'Initials': 'IM', 'LastName': 'Krishnakumar', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Ratheesh', 'Initials': 'R', 'LastName': 'Mohanan', 'Affiliation': 'Department of Biochemistry, St. Thomas College, Kottayam, India.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0128']
3101,32678713,Optimization of Photobiomodulation Protocol for Chemotherapy-Induced Mucositis in Pediatric Patients.,"Objective:  To determine optimal settings of a specific diode laser for reducing the severity of oral mucositis (OM) in pediatric patients.  Background:  Photobiomodulation (PBM) has been reported to reduce the severity of chemotherapy-induced OM. Treatment parameters for PBM are difficult to determine due to different reports in the literature.  Materials and methods:  Patients with OM graded WHO 3 or 4 were randomly assigned to three groups with different laser settings (group A: power 250 mW, the energy density 8.8 and 15.5 J/cm 2  for WHO grade 3 and 4, respectively; group B: power 500 mW, energy density as in group A; group C: power 250 mW, energy density was half of groups A and B). PBM was performed on all lesion areas. The mean number of PBM sessions to a decrease from WHO 3 or 4 to WHO 2, 1, or 0 was calculated for each patient. Multiple linear regression was used to determine whether the test groups differed in the mean number of sessions to a decrease of OM.  Results:  The mean number of PBM sessions to reduce from severe mucositis to mild or no mucositis was 3.8 [standard deviation (SD) = 3.5] in group A, 4.4 (SD = 2.3) in group B, and 4.0 (SD = 2.7) in group C. The differences in the number of PBM sessions for OM severity decrease were not statistically significantly different among the three study groups.  Conclusions:  Because of the lack of statistically significant differences between the groups, more patient practical laser parameters could be applied, that is, a shorter irradiation time.",2020,Multiple linear regression was used to determine whether the test groups differed in the mean number of sessions to a decrease of OM.  ,"['Patients with OM graded WHO 3 or 4', 'Pediatric Patients', 'pediatric patients']","[':  Photobiomodulation (PBM', 'specific diode laser']","['number of PBM sessions for OM severity decrease', 'mean number of PBM sessions', 'severe mucositis to mild or no mucositis', 'severity of oral mucositis (OM', 'PBM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",,0.0295031,Multiple linear regression was used to determine whether the test groups differed in the mean number of sessions to a decrease of OM.  ,"[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Tomaževič', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Dental Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Urša', 'Initials': 'U', 'LastName': 'Potočnik', 'Affiliation': 'Dental Studio Škrlj Golob, Domžale, Slovenia.'}, {'ForeName': 'Daša', 'Initials': 'D', 'LastName': 'Cizerl', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Dental Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Janez', 'Initials': 'J', 'LastName': 'Jazbec', 'Affiliation': ""Department of Oncology and Haematology, Children's Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia.""}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4794']
3102,32678716,Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial.,"PURPOSE


NALA (ClinicalTrials.gov identifier: NCT01808573) is a randomized, active-controlled, phase III trial comparing neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) with ≥ 2 previous HER2-directed MBC regimens.
METHODS


Patients, including those with stable, asymptomatic CNS disease, were randomly assigned 1:1 to neratinib (240 mg once every day) plus capecitabine (750 mg/m 2  twice a day 14 d/21 d) with loperamide prophylaxis, or to lapatinib (1,250 mg once every day) plus capecitabine (1,000 mg/m 2  twice a day 14 d/21 d). Coprimary end points were centrally confirmed progression-free survival (PFS) and overall survival (OS). NALA was considered positive if either primary end point was met (α split between end points). Secondary end points were time to CNS disease intervention, investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate, safety, and health-related quality of life (HRQoL).
RESULTS


A total of 621 patients from 28 countries were randomly assigned (N+C, n = 307; L+C, n = 314). Centrally reviewed PFS was improved with N+C (hazard ratio [HR], 0.76; 95% CI, 0.63 to 0.93; stratified log-rank  P = . 0059). The OS HR was 0.88 (95% CI, 0.72 to 1.07;  P = . 2098). Fewer interventions for CNS disease occurred with N+C versus L+C (cumulative incidence, 22.8%  v  29.2%;  P = . 043). ORRs were N+C 32.8% (95% CI, 27.1 to 38.9) and L+C 26.7% (95% CI, 21.5 to 32.4;  P = . 1201); median DoR was 8.5 versus 5.6 months, respectively (HR, 0.50; 95% CI, 0.33 to 0.74;  P = . 004). The most common all-grade adverse events were diarrhea (N+C 83%  v  L+C 66%) and nausea (53%  v  42%). Discontinuation rates and HRQoL were similar between groups.
CONCLUSION


N+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.",2020,N+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.,"['Patients, including those with stable, asymptomatic CNS disease', 'HER2-Positive Metastatic Breast Cancer', 'patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) with ≥ 2 previous HER2-directed MBC regimens', '621 patients from 28 countries were randomly assigned (N+C, n = 307; L+C, n = 314']","['NALA', 'Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine', 'loperamide prophylaxis, or to lapatinib', 'capecitabine', 'N+C', 'capecitabine (L+C', 'capecitabine (N+C) against lapatinib']","['time to CNS disease intervention, investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate, safety, and health-related quality of life (HRQoL', 'progression-free survival (PFS) and overall survival (OS', 'median DoR', 'ORRs', 'Discontinuation rates and HRQoL', 'nausea', 'diarrhea ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",621.0,0.378684,N+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), SOLTI Breast Cancer Cooperative Group, Barcelona, Spain.""}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), SOLTI Breast Cancer Cooperative Group, Barcelona, Spain.""}, {'ForeName': 'Yin-Hsun', 'Initials': 'YH', 'LastName': 'Feng', 'Affiliation': 'Chi Mei Medical Centre, Liouying, Tainan, Taiwan and Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Shen', 'Initials': 'MS', 'LastName': 'Dai', 'Affiliation': 'Chi Mei Medical Centre, Liouying, Tainan, Taiwan and Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shang-Wen', 'Initials': 'SW', 'LastName': 'Chen', 'Affiliation': 'Chi Mei Medical Centre, Liouying, Tainan, Taiwan and Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Moy', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gradishar', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Palacova', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Trudeau', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mattson', 'Affiliation': 'Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.'}, {'ForeName': 'Yoon Sim', 'Initials': 'YS', 'LastName': 'Yap', 'Affiliation': 'National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Ming-Feng', 'Initials': 'MF', 'LastName': 'Hou', 'Affiliation': 'Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'National Cancer Institute Fondazione Pascale, Napoli, Italy.'}, {'ForeName': 'Yu-Min', 'Initials': 'YM', 'LastName': 'Yeh', 'Affiliation': 'National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hong-Tai', 'Initials': 'HT', 'LastName': 'Chang', 'Affiliation': 'Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': 'Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Haley', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Fagnani', 'Affiliation': 'ASST di Vimercate, Vimercate, Italy.'}, {'ForeName': 'Yen-Shen', 'Initials': 'YS', 'LastName': 'Lu', 'Affiliation': 'National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Crown', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Graduate School of Medicine, Gunma University, Gunma, Japan.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bebchuk', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Keyvanjah', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryce', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': 'Magee-Womens Hospital of UPMC, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00147']
3103,32678725,"A Randomized Blinded Retrospective Study: the combined use of Micro-needling Technique, Low-Level Laser Therapy and Autologous Non-Activated Platelet-Rich Plasma improves Hair Re-Growth in patients with Androgenic Alopecia.","INTRODUCTION


Mini-invasive therapies based on autologous non-activated Platelet-Rich Plasma (ANA-PRP), Low-Level Laser Therapy (LLL-T), and Micro-Needling Technique (MN-T) used in combining for hair re-growth need to be standardized.
OBJECTIVES


The work aims to show  in vivo  outcomes resulted from retrospective case-series study in which ANA-PRP + MN-T + LLL-T were used in combined in patients affected by Androgenic alopecia.
METHODS


23 patients were treated, of which 13 males were classified in stage I - V by the Norwood-Hamilton scale, and 10 females were classified in stage I - III by the Ludwig scale. Assessment of hair re-growth was evaluated with photography, physician's and patient's global assessment scale, and standardized phototrichograms during a follow-up: T0 - baseline, T1 - 12 weeks, T2 - 23 weeks, T3 - 44 weeks, T4 - 58 weeks.
RESULTS


Interesting outcomes represented by a hair density increase of 81 ± 5 hairs/cm 2  and 57 ± 7 hairs/cm 2  respectively at T1 and T2 compared with baseline (173 ± 5 hairs/cm 2  at T1 and 149 ± 9 hairs/cm 2  at T2 versus 92 ± 2 hairs/cm 2  at baseline) were observed using computerized trichograms.
CONCLUSIONS


The effect of the combined use of MN-T, LLL-T, and ANA-PRP has been demonstrated.",2020,"Interesting outcomes represented by a hair density increase of 81 ± 5 hairs/cm 2  and 57 ± 7 hairs/cm 2  respectively at T1 and T2 compared with baseline (173 ± 5 hairs/cm 2  at T1 and 149 ± 9 hairs/cm 2  at T2 versus 92 ± 2 hairs/cm 2  at baseline) were observed using computerized trichograms.
","['patients with Androgenic Alopecia', '23 patients were treated, of which 13 males were classified in stage I - V by the Norwood-Hamilton scale, and 10 females were classified in stage I - III by the Ludwig scale']","['Micro-needling Technique, Low-Level Laser Therapy and Autologous Non-Activated Platelet-Rich Plasma', 'ANA-PRP + MN-T + LLL-T', 'MN-T, LLL-T, and ANA-PRP', 'Mini-invasive therapies based on autologous non-activated Platelet-Rich Plasma (ANA-PRP), Low-Level Laser Therapy (LLL-T), and Micro-Needling Technique (MN-T']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],13.0,0.0364,"Interesting outcomes represented by a hair density increase of 81 ± 5 hairs/cm 2  and 57 ± 7 hairs/cm 2  respectively at T1 and T2 compared with baseline (173 ± 5 hairs/cm 2  at T1 and 149 ± 9 hairs/cm 2  at T2 versus 92 ± 2 hairs/cm 2  at baseline) were observed using computerized trichograms.
","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Gentile', 'Affiliation': 'Department of Surgical Sciences, Plastic and Reconstructive Surgery, University of Rome ""Tor Vergata"" School of Medicine , Rome, 00173, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dionisi', 'Affiliation': 'Dionisi Law Firm , Rome, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Pizzicannella', 'Affiliation': 'ASL02 Lanciano-Vasto Chieti, Ss. Annunziata Hospital, zip code Chieti , Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'De Angelis', 'Affiliation': 'Department of Surgical Sciences, Plastic and Reconstructive Surgery, University of Rome ""Tor Vergata"" School of Medicine , Rome, 00173, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'De Fazio', 'Affiliation': 'Institute of Plastic Surgery, Galeazzi Hospital , 20122 Milan, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Garcovich', 'Affiliation': 'Institute of Dermatology, F. Policlinico Gemelli IRCSS, Università Cattolica del Sacro Cuore , 00168 Rome, Italy; simgarko@yahoo.it.'}]",Expert opinion on biological therapy,['10.1080/14712598.2020.1797676']
3104,32679201,Predicting Nasal High-Flow Treatment Success in Newborn Infants with Respiratory Distress Cared for in Non-Tertiary Hospitals.,"OBJECTIVE


To evaluate demographic and clinical variables as predictors of nasal high-flow treatment success in newborn infants with respiratory distress cared for in Australian non-tertiary special care nurseries (SCNs).
STUDY DESIGN


A secondary analysis of the HUNTER trial, a multicentre, randomized controlled trial evaluating nHF as primary respiratory support for newborn infants, born ≥31 weeks' gestation and had a birth weight ≥1200g, with respiratory distress, cared for in Australian non-tertiary SCNs, was performed. Treatment success within 72 hours after randomization to nHF was determined using objective criteria. Univariable screening and multivariable analysis was used to determine predictors of nHF treatment success.
RESULTS


Infants (n =363) randomized to nHF in HUNTER were included in the analysis; mean (standard deviation) gestational age was 36.9 (2.7) weeks and birth weight 2928 (782) grams. Of these, 290 ( 80%) experienced nHF treatment success. On multivariable analysis, nHF treatment success was predicted by higher gestational age and lower fraction of inspired oxygen immediately prior to randomization, but not strongly. The final model was found to have an area under the curve of 0.65, which after adjustment for optimism was found to be 0.63 (95% confidence interval: 0.57-0.70).
CONCLUSION


Gestational age and supplemental oxygen requirement may be used to guide decisions regarding the most appropriate initial respiratory support for newborn infants in non-tertiary SCNs. Further prospective research is required to better identify which infants are most likely to be successfully treated with nHF.",2020,"The final model was found to have an area under the curve of 0.65, which after adjustment for optimism was found to be 0.63 (95% confidence interval: 0.57-0.70).
","['Newborn Infants with Respiratory Distress Cared for in Non-Tertiary Hospitals', 'in HUNTER were included in the analysis', 'newborn infants in non-tertiary SCNs', 'Infants (n =363) randomized to', 'gestational age was 36.9 (2.7) weeks and birth weight 2928 (782) grams', 'newborn infants with respiratory distress cared for in Australian non-tertiary special care nurseries (SCNs', ""newborn infants, born ≥31 weeks' gestation and had a birth weight ≥1200g, with respiratory distress, cared for in Australian non-tertiary SCNs, was performed""]",['nHF'],"['Nasal High-Flow Treatment Success', 'nHF treatment success', 'mean (standard deviation']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",[],"[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",363.0,0.209507,"The final model was found to have an area under the curve of 0.65, which after adjustment for optimism was found to be 0.63 (95% confidence interval: 0.57-0.70).
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McKimmie-Doherty', 'Affiliation': ""Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne; Newborn Research Centre, The Royal Women's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gaston Rb', 'Initials': 'GR', 'LastName': 'Arnolda', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, New South Wales, Australia; University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Buckmaster', 'Affiliation': 'Paediatrics, Central Coast Local Health District, Gosford, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Hodgson', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Paediatric Infant Perinatal Emergency Retrieval, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ian Mr', 'Initials': 'IM', 'LastName': 'Wright', 'Affiliation': 'Illawarra Health and Medical Research Institute, and Graduate Medicine, University of Wollongong, Wollongong, New South Wales, Australia; Illawarra and Shoalhaven Health District, Wollongong, New South Wales, Australia; The University of Queensland Centre for Clinical Research, The University of Queensland, Brisbane, Queensland, Australia; James Cook University, Douglas, Queensland, Australia.'}, {'ForeName': 'Calum T', 'Initials': 'CT', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, Australia; Department of Paediatrics, Monash University, Melbourne, Australia.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia. Electronic address: Brett.Manley@thewomens.org.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.07.037']
3105,32679209,Intralymphatic Immunotherapy improves grass pollen allergic rhinoconjunctivitis. A three-year randomized placebo-controlled trial.,"BACKGROUND


Allergic rhinoconjunctivitis is a global health problem. Different Allergen ImmunoTherapy (AIT) regimes are marketed but have low adherence because they are expensive, complex and time consuming. New AIT forms are needed.
OBJECTIVE


In a three-year follow-up double-blinded randomized placebo-controlled trial we aimed to investigate effect of intralymphatic AIT (ILIT).
METHODS


Patients with grass pollen rhinoconjunctivitis were treated with either three ILIT injections and an ILIT booster one year later, three ILIT injection and a placebo booster or three placebo injections and a placebo booster. Primary outcome was improvement in a combined symptom and medication score, cSMS. A novel evaluation tool with a linear regression model of cSMS and grass pollen counts was developed. Secondary outcomes were changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen.
RESULTS


36 patients were included. Log 10  transformed cSMS was reduced by 0.30 (95%CI 0.11 - 0.49), p=0.002 equalling 48.5% (95%CI 24.5% - 62%), in the entirethree-year follow-up period, significant only in the first follow-up season but not in the second and third season. The regression model showed a 37%, p<0.001, reduction in cSMS. The booster injection had no additional. Secondary, repeated measures of IgE and IgG 4  to grass, showed significant between-group difference and within-group change in the ILIT groups. No change in provocation test was found.
CONCLUSION


Intralymphatic immune therapy gives a substantial reduction in grass pollen allergy symptoms and use of rescue medication, significant in the first season after treatment. A booster injection had no additional effect.",2020,"Secondary, repeated measures of IgE and IgG 4  to grass, showed significant between-group difference and within-group change in the ILIT groups.","['36 patients were included', 'Patients with grass pollen rhinoconjunctivitis']","['ILIT injections and an ILIT booster one year later, three ILIT injection and a placebo booster or three placebo injections and a placebo booster', 'intralymphatic AIT (ILIT', 'Intralymphatic Immunotherapy', 'placebo']","['grass pollen allergic rhinoconjunctivitis', 'provocation test', 'cSMS', 'combined symptom and medication score, cSMS', 'repeated measures of IgE and IgG 4  to grass', 'changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}]","[{'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162352', 'cui_str': 'Hyposensitization to allergens'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0027431', 'cui_str': 'Nasal provocation test'}]",36.0,0.678572,"Secondary, repeated measures of IgE and IgG 4  to grass, showed significant between-group difference and within-group change in the ILIT groups.","[{'ForeName': 'Søren Helbo', 'Initials': 'SH', 'LastName': 'Skaarup', 'Affiliation': 'Department of respiratory diseases and allergy. Aarhus University Hospital. Denmark.'}, {'ForeName': 'Johannes Martin', 'Initials': 'JM', 'LastName': 'Schmid', 'Affiliation': 'Department of Respiratory Diseases and Allergy. Aarhus University Hospital. Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Skjold', 'Affiliation': 'Department of Respiratory Diseases and Allergy. Aarhus University Hospital. Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Graumann', 'Affiliation': 'Department of Radiology. Odense University Hospital. Denmark. Head of research and innovation unit of radiology, University of Southern Denmark.'}, {'ForeName': 'Hans Jürgen', 'Initials': 'HJ', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Respiratory Diseases and Allergy. Aarhus University Hospital. Denmark; Department of Clinical Medicine. Aarhus University. Denmark. Electronic address: hjh@clin.au.dk.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.07.002']
3106,32679238,Self-reported snoring patterns predict stroke events in high-risk patients with obstructive sleep apnea: post-hoc analyses of the SAVE study.,"BACKGROUND


The relation of snoring to risks of stroke and other major cardiovascular (CV) events is uncertain.
RESEARCH QUESTION


We aimed to determine associations of snoring patterns and major CV events in relation to the obstructive sleep apnea (OSA), among participants of the international Sleep Apnea cardiovascular Endpoints (SAVE) trial.
STUDY DESIGN


and Methods: Post-hoc analyses of the SAVE trial, which involved 2687 patients with co-existing moderate-severe OSA and established coronary or cerebral CV disease, who were randomly allocated to continuous positive airway pressure (CPAP) treatment plus usual care or usual care alone, and followed up for a median 3.5 years. Associations of self-reported snoring patterns (frequency and loudness) and breathing pauses collected on the Berlin questionnaire at baseline and multiple times during follow-up, and adjudicated composites of CV outcomes (primary, CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina, heart failure, or transient ischemic attack; and separately of cardiac and cerebral events), were evaluated in time-dependent Cox proportional hazards models adjusted for various confounders including apnea-hypopnea index.
RESULTS


Increase (per category) of snoring frequency (adjusted hazard ratio [HR] 1.10, 95% confidence interval [CI] 1.02-1.20; P=0.015), loudness (HR 1.16, 95% CI 1.06-1.27; P=0.001), and breathing pauses (HR 1.16, 95% CI 1.08-1.25; P<0.001) at any timepoint during follow-up were each associated with the primary composite CV outcome. These associations were driven by significant associations for cerebral rather than cardiac events, and positive interactions between the three snoring patterns for cerebral events. There is no significant interaction between CPAP treatment and snoring variables for cerebral events.
INTERPRETATION


Snoring in OSA patients with established CV disease is associated with greater risks of cerebral but not cardiac events, independent of CPAP treatment and frequency of apnea and hypopnea events.
CLINICAL TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov (NCT00738179).",2020,"These associations were driven by significant associations for cerebral rather than cardiac events, and positive interactions between the three snoring patterns for cerebral events.","['high-risk patients with obstructive sleep apnea', '2687 patients with co-existing moderate-severe OSA and established coronary or cerebral CV disease', 'OSA patients with established CV disease']","['Self-reported snoring patterns', 'continuous positive airway pressure (CPAP) treatment plus usual care or usual care alone']","['breathing pauses', 'CV outcomes (primary, CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina, heart failure, or transient ischemic attack; and separately of cardiac and cerebral events', 'snoring patterns (frequency and loudness) and breathing pauses', 'snoring frequency (adjusted hazard ratio [HR', 'apnea-hypopnea index']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",2687.0,0.0769172,"These associations were driven by significant associations for cerebral rather than cardiac events, and positive interactions between the three snoring patterns for cerebral events.","[{'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Xinqiao Hospital, Third Military Medical University, Chongqing, China; Department of Cardiology, People's Liberation Army General Hospital, Beijing, China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia.""}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia; Pharmacology Discipline, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Loffler', 'Affiliation': 'The Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""The Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, United States of America.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Centre for Biostatistics & Epidemiology, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia; The George Institute China at Peking University Health Science Center, Beijing, PR China; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Australia; Heart Health Research Center, Beijing, China; Universidad del Desarrollo, School of Medicine-Clínica Alemana, ICIM, Center for Clinical Studies, Santiago, Chile. Electronic address: canderson@georgeinstitute.org.au.'}]",Chest,['10.1016/j.chest.2020.05.615']
3107,32679239,Low prognostic value of novel nocturnal oxygen saturation metrics in patients with obstructive sleep apnea and high cardiovascular event risk: post-hoc analyses of the SAVE study.,"BACKGROUND


Traditional methods for quantifying obstructive sleep apnea (OSA) severity may not encapsulate potential relationships between hypoxaemia in OSA and cardiovascular (CV) risk.
RESEARCH QUESTION


Do novel nocturnal oxygen saturation metrics have prognostic value in patients with OSA and high cardiovascular event risk?
STUDY DESIGN


Post-hoc analyses of the Sleep Apnea CV Endpoints (SAVE) trial.
METHODS


In 2687 individuals, Cox proportional hazards models stratified for treatment allocation were used to determine the associations between clinical characteristics, pulse oximetry-derived metrics designed to quantify sustained and episodic features of hypoxaemia, and CV outcomes. Metrics included: oxygen desaturation index, time <90% oxygen saturation (SpO 2 ), average SpO 2  for the entire recording (mean SpO 2 ); average SpO 2  during desaturation events (desaturation SpO 2 ); average baseline SpO 2  interpolated across episodic desaturation events (baseline SpO 2 ); episodic desaturation event duration and desaturation/resaturation-time ratio; mean and standard deviation of pulse rate.
RESULTS


Neither AHI, ODI nor any of the novel SpO 2  metrics were associated with the primary SAVE composite CV outcome. Mean and baseline SpO 2  were associated with heart failure (hazard ratio [HR] 0.81, 95% confidence interval [CI] 0.69-0.95; P=0.009 and HR 0.78, 95% CI 0.67-0.90; P=0.001, respectively) and myocardial infarction (HR 0.86, 95% CI 0.77-0.95; P=0.003 and HR 0.81, 95% CI 0.73-0.90; P<0.001, respectively). Desaturation duration and desaturation/resaturation-time ratio, with established risk factors, predicted future heart failure (AUC 0.86, 95% CI 0.79-0.93).
INTERPRETATION


AHI and ODI were not associated with CV outcomes. In contrast, the pattern of oxygen desaturation was associated with heart failure and myocardial infarction. However, concomitant risk factors remained the predominant determinants for secondary CV events and thus deserve the most intensive management.",2020,"Neither AHI, ODI nor any of the novel SpO 2  metrics were associated with the primary SAVE composite CV outcome.","['patients with OSA and high cardiovascular event risk', 'patients with obstructive sleep apnea and high cardiovascular event risk']",['novel nocturnal oxygen saturation metrics'],"['oxygen desaturation index, time <90% oxygen saturation (SpO 2 ), average SpO 2  for the entire recording (mean SpO 2 ); average SpO 2  during desaturation events (desaturation SpO 2 ); average baseline SpO 2  interpolated across episodic desaturation events (baseline SpO 2 ); episodic desaturation event duration and desaturation/resaturation-time ratio; mean and standard deviation of pulse rate', 'heart failure', 'myocardial infarction', 'Desaturation duration and desaturation/resaturation-time ratio, with established risk factors, predicted future heart failure', 'heart failure and myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0539802,"Neither AHI, ODI nor any of the novel SpO 2  metrics were associated with the primary SAVE composite CV outcome.","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Linz', 'Affiliation': 'Centre for Heart Rhythm Disorders (CHRD), South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia; Department of Cardiology, Maastricht University Medical Centre, Maastricht, Cardiovascular Research Institute Maastricht (CARIM), University Maastricht, Maastricht, The Netherlands; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands. Electronic address: Dominik.Linz@adelaide.edu.au.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Loffler', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Centre for Heart Rhythm Disorders (CHRD), South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Neurology Department, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'WeiWei', 'Initials': 'W', 'LastName': 'Quan', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Cardiology, Rui Jin Hospital and Institute of Cardiovascular Diseases, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barnes', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School.""}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), College of Medicine and Public Health, Flinders University, Adelaide, Australia; Sleep Health Service, Respiratory and Sleep Services, Southern Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Baumert', 'Affiliation': 'University of Adelaide, School of Electrical and Electronic Engineering, Adelaide, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.06.072']
3108,32679434,"Diet-induced differences in estimated plasma glucose concentrations in healthy, non-diabetic adults are detected by continuous glucose monitoring-a randomized crossover trial.","Continuous glucose monitors (CGMs) have been developed for diabetic patients for estimating and controlling plasma glucose changes throughout the day. However, elevated postprandial glucose concentrations may also be detrimental for non-diabetic subjects by increasing the risk of developing vascular complications and type 2 diabetes. Therefore, CGMs may also be valuable in clinical research and we hypothesized that diet-induced differences in estimated plasma glucose concentrations in healthy, non-diabetic adults could be detected by the Abbott FreeStyle Libre Pro CGM. In this single-blind randomized cross-over trial, 23 healthy but overweight or obese men and women therefore consumed two diets differing in glycemic load in randomized order for three consecutive days. Based on the CGM measurements, two-hour total areas under the curve (tAUCs) after breakfast, lunch and dinner were calculated. Additionally, postprandial glucose was measured with the CGM and in plasma during a rice meal challenge. The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001). The same conclusions were drawn when tAUCs for breakfast (P < .0001), lunch (P < .0001) and dinner (P < .0001) were analyzed separately. During the rice meal challenge, significantly higher glucose responses were observed after the low GL period, as monitored by both the CGM device (P < .0001) and the plasma glucose analysis (P < .0001). The difference between the means of both methods was 0.11 mmol/L (1.78%) with a higher glucose value in plasma. The absolute mean difference was 0.66 mmol/L (10.5%). We conclude that the CGM detected diet-induced differences in estimated plasma glucose concentrations, which supports its use not only in clinical practice, but also for research purposes during dietary interventions in non-diabetic participants.",2020,The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001).,"['healthy, non-diabetic adults', '23 healthy but overweight or obese men and women', 'non-diabetic participants', 'diabetic patients']",['Continuous glucose monitors (CGMs'],"['elevated postprandial glucose concentrations', 'average tAUC', 'glucose responses', 'plasma glucose analysis', 'plasma glucose concentrations', 'postprandial glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}]",23.0,0.0315526,The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001).,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fechner', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: eva.fechner@outlook.com.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': ""Op 't Eyndt"", 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: cara.opteyndt@mumc.nl.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Unilever Foods Innovation Center - Hive, Bronland 14, 6708, WH, Wageningen, The Netherlands. Electronic address: theo.mulder@unilever.com.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: r.mensink@maastrichtuniversity.nl.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.06.001']
3109,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
3110,32679568,Effect of High-Intensity Interval Training Versus Moderate-Intensity Aerobic Continuous Training on Galectin-3 Gene Expression in Postmenopausal Women: A Randomized Controlled Trial.,"Galectin-3 is a pro-inflammatory biomarker associated with the pathogenesis of heart failure (HF). Physical-activity reduces the risk of heart-failure by modification of inflammation and fibrosis. The purpose of this study was to compare the effects of 8 weeks of high-intensity interval training (HIIT) versus moderate-intensity aerobic continuous training on a predictive factor of HF in postmenopausal women. Thirty sedentary postmenopausal women were randomly assigned to three groups. The first group performed the HIIT program at 60%-90%, and the second group performed an exercise program at 50%-65% of HR reserve. The control group maintained their normal daily regular physical activity level. The gene expressions of galectin-3 and lipid profiles were measured at the baseline and the end of Week 8. The HIIT and moderate-intensity aerobic continuous training attenuated the gene expression of galectin-3, serum low-density lipoprotein, cholesterol, and triglyceride concentrations and enhanced high-density lipoprotein concentrations. These changes were considerably higher in the HIIT group. Our results show that HIIT is superior to moderate-intensity aerobic continuous training in improving the decrease in HF risk in postmenopausal women.",2020,"The HIIT and moderate-intensity aerobic continuous training attenuated the gene expression of galectin-3, serum low-density lipoprotein, cholesterol, and triglyceride concentrations and enhanced high-density lipoprotein concentrations.","['Postmenopausal Women', 'postmenopausal women', 'Thirty sedentary postmenopausal women']","['exercise program', 'High-Intensity Interval Training Versus Moderate-Intensity Aerobic Continuous Training', 'high-intensity interval training (HIIT) versus moderate-intensity aerobic continuous training']","['gene expression of galectin-3, serum low-density lipoprotein, cholesterol, and triglyceride concentrations and enhanced high-density lipoprotein concentrations', 'HF risk', 'Galectin-3 Gene Expression', 'gene expressions of galectin-3 and lipid profiles']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",30.0,0.0240443,"The HIIT and moderate-intensity aerobic continuous training attenuated the gene expression of galectin-3, serum low-density lipoprotein, cholesterol, and triglyceride concentrations and enhanced high-density lipoprotein concentrations.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Keyhani', 'Affiliation': ''}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ''}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Dabiri', 'Affiliation': ''}, {'ForeName': 'Ana Maria Botelho', 'Initials': 'AMB', 'LastName': 'Teixeira', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0213']
3111,32679601,"Single-bite versus double-bite technique for mapping biopsies during endoscopic surveillance for hereditary diffuse gastric cancer: a single-center, randomized trial.","BACKGROUND : Endoscopic surveillance is recommended in patients with hereditary diffuse gastric cancer (HDGC) who refuse or want to delay surgery. Because early signet-ring cell carcinoma (SRCC) can be inconspicuous, the current surveillance endoscopy protocol entails 30 random biopsies, which are time-consuming. This study aimed to compare single-bite and double-bite techniques in HDGC surveillance. METHODS : Between October 2017 and December 2018, consecutive patients referred for HDGC surveillance were prospectively randomized to the single- or double-bite arm. The primary outcome was the diagnostic yield for SRCC foci. Secondary outcomes were: procedural time for random biopsies; comfort score; biopsy size; and quality of specimens, the latter assessed by the presence of muscularis mucosa, crush artifact, and proportion usable for diagnostic assessment. RESULTS : 25 patients were randomized to the single-bite arm and 23 to the double-bite arm. SRCC foci were detected in three and four patients in the single- and double-bite arms, respectively ( P  = 0.70). The procedural time for the double-bite arm (12 minutes, interquartile range [IQR] 4) was significantly shorter than for the single-bite arm (15 minute, IQR 6;  P  = 0.01), but comfort scores were similar. The size of the biopsies in the double-bite arm was significantly smaller than in single-bite arm (2.5 mm vs. 3.0 mm;  P  < 0.001) but this did not affect the presence of muscularis mucosa ( P  = 0.73), artifact level ( P  = 0.11), and diagnostic utility ( P  = 0.051). CONCLUSION : For patients undergoing HDGC surveillance, the double-bite technique is significantly faster than the single-bite technique. The diagnostic yield for SRCC and the biopsy quality were similar across both groups.",2020,The diagnostic yield for SRCC and the biopsy quality were similar across both groups.,"['Between October 2017 and December 2018, consecutive patients referred for HDGC surveillance', '25 patients', 'hereditary diffuse gastric cancer', 'patients with hereditary diffuse gastric cancer (HDGC) who refuse or want to delay surgery']","['Single-bite versus double-bite technique', 'Endoscopic surveillance']","['size of the biopsies', 'procedural time for random biopsies; comfort score; biopsy size; and quality of specimens, the latter assessed by the presence of muscularis mucosa, crush artifact, and proportion usable for diagnostic assessment', 'diagnostic utility', 'diagnostic yield for SRCC foci', 'procedural time', 'SRCC foci', 'diagnostic yield for SRCC and the biopsy quality', 'presence of muscularis mucosa', 'artifact level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1708349', 'cui_str': 'Gastric Cancer, Familial Diffuse'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0225357', 'cui_str': 'Muscularis mucosae'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0431080', 'cui_str': 'Diagnostic assessment'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206696', 'cui_str': 'Signet ring cell carcinoma'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.289291,The diagnostic yield for SRCC and the biopsy quality were similar across both groups.,"[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': 'MRC Cancer Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Wei Keith', 'Initials': 'WK', 'LastName': 'Tan', 'Affiliation': 'MRC Cancer Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Waldock', 'Affiliation': 'MRC Cancer Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Richardson', 'Affiliation': 'Department of Oncology, Addenbrookes Hospital, Cambridge University NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Histopathology, Addenbrookes Hospital, Cambridge University NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Wladyslaw', 'Initials': 'W', 'LastName': 'Januszewicz', 'Affiliation': 'MRC Cancer Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Department of Surgery, Addenbrookes Hospital, Cambridge University NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Histopathology, Addenbrookes Hospital, Cambridge University NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Fitzgerald', 'Affiliation': 'MRC Cancer Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'di Pietro', 'Affiliation': 'MRC Cancer Unit, University of Cambridge, Cambridge, UK.'}]",Endoscopy,['10.1055/a-1201-3125']
3112,32680341,"A pilot randomized controlled trial comparing computer-assisted cognitive rehabilitation, stimulant medication, and an active control in the treatment of ADHD.","BACKGROUND


This research aimed to compare computer-assisted cognitive rehabilitation (CACR) psychostimulants (MED) and placebo CACR (PCACR) in the treatment of ADHD using a multiarm parallel design.
METHODS


Thirty-four boys with ADHD, aged 7-12, were randomly assigned to either CACR (n = 12), MED (n = 11), or PCACR (n = 11). However, the study was not blinded and medication doses might be suboptimal given the lack of titration. Continuous performance test, Tower-of-London, forward/backward digit span, span board, Raven's progressive matrices, and SNAP-IV were completed at baseline, posttest, and follow-up.
RESULTS


Computer-assisted cognitive rehabilitation outperformed both MED and PCACR on backward digit span at posttest and PCACR at follow-up. CACR outperformed PCACR and MED on forward digit span at posttest and PCACR at follow-up. CACR outperformed MED on span board at posttest. CACR outperformed PCACR and MED on Raven's matrices at posttest. CACR and PCACR scored lower than MED on ADHD-PHI at posttest. CACR scored lower than MED on ADHD-C at posttest.
CONCLUSIONS


Immediately after interventions, CACR improved certain simple executive functions (EFs) as much as active stimulant medication. On complex EFs, CACR was superior to active stimulant medication and PCACR. CACR reduced behavioral symptoms of ADHD more than active stimulant medication. However, at 3-month follow-up, maintenance of the CACR gains was weak.",2016,"RESULTS


Computer-assisted cognitive rehabilitation outperformed both MED and PCACR on backward digit span at posttest and PCACR at follow-up.","['Thirty-four boys with ADHD, aged 7-12']","['CACR', 'computer-assisted cognitive rehabilitation (CACR) psychostimulants (MED) and placebo CACR (PCACR', 'PCACR', 'computer-assisted cognitive rehabilitation, stimulant medication']","['CACR outperformed PCACR and MED on forward digit span', ""Continuous performance test, Tower-of-London, forward/backward digit span, span board, Raven's progressive matrices, and SNAP-IV"", 'backward digit span', 'CACR and PCACR', 'CACR gains', 'behavioral symptoms of ADHD']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0475506', 'cui_str': 'Ravens colored progressive matrices'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",34.0,0.017074,"RESULTS


Computer-assisted cognitive rehabilitation outperformed both MED and PCACR on backward digit span at posttest and PCACR at follow-up.","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Azami', 'Affiliation': 'Department of Clinical and General Psychology, Allameh Tabatabai University, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Moghadas', 'Affiliation': 'Department of Clinical and General Psychology, Allameh Tabatabai University, Tehran, Iran.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Sohrabi-Esmrood', 'Affiliation': 'Department of Clinical and General Psychology, Allameh Tabatabai University, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nazifi', 'Affiliation': 'Department of Psychology, University of Bojnord, Bojnord, 9453155111, Iran.'}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Mirmohamad', 'Affiliation': 'Institute for Brain and Cognitive Sciences, Shahid-Beheshti University, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hemmati', 'Affiliation': 'Department of Psychology, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Clinical and General Psychology, Allameh Tabatabai University, Tehran, Iran.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Hamzeh-Poor', 'Affiliation': 'Department of Clinical and General Psychology, Allameh Tabatabai University, Tehran, Iran.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Khari', 'Affiliation': 'Al-Zahra University, Tehran, Iran.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Lakes', 'Affiliation': 'Department of Pediatrics, University of California, Irvine, CA, USA.'}]",Child and adolescent mental health,['10.1111/camh.12157']
3113,32680363,"Effectiveness of brief school-based, group cognitive behavioural therapy for depressed adolescents in south west Nigeria.","BACKGROUND


There is paucity of evidence-based psychological interventions for depressive disorders in Africa, more so among depressed children and adolescents. This study aimed to determine the effects of a school-based cognitive behavioural therapy programme (CBT) on depressed adolescents in South West Nigeria.
METHODS


Forty students who scored 18 or above on the Beck Depression Inventory (BDI) were recruited from two schools (20 from each school). One school was designated intervention and the other a wait-list control school. Five weekly sessions of group CBT programme were conducted in the intervention school. Primary outcome measure was the Beck Depression Inventory, and secondary outcome measures were the Short Mood and Feelings Questionnaire and the Impact Supplement of the Strengths and Difficulties Questionnaire.
RESULTS


Controlling for baseline scores and other confounders, the intervention group had significantly lower depressive symptoms scores on the BDI and SMFQ 1 week post intervention with large effect sizes. The intervention group maintained the treatment effect with significantly lower depression scores 16 weeks post intervention compared with their baseline scores. The effect sizes remained large. The intervention and control groups did not differ in their SDQ impact supplement scores post intervention, but the intervention group improved significantly on this measure at 16 weeks.
CONCLUSIONS


To our knowledge, this is the first study of a school-based group CBT programme for depressed adolescents in Africa. The programme showed good feasibility and promising effectiveness.",2016,"The intervention and control groups did not differ in their SDQ impact supplement scores post intervention, but the intervention group improved significantly on this measure at 16 weeks.
","['depressed adolescents in South West Nigeria', 'depressed adolescents in Africa', 'Forty students who scored 18 or above on the Beck Depression Inventory (BDI) were recruited from two schools (20 from each school', 'depressed children and adolescents', 'depressed adolescents in south west Nigeria']","['school-based cognitive behavioural therapy programme (CBT', 'brief school-based, group cognitive behavioural therapy']","['Short Mood and Feelings Questionnaire and the Impact Supplement of the Strengths and Difficulties Questionnaire', 'Beck Depression Inventory', 'depressive symptoms scores', 'depression scores']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",40.0,0.060686,"The intervention and control groups did not differ in their SDQ impact supplement scores post intervention, but the intervention group improved significantly on this measure at 16 weeks.
","[{'ForeName': 'Tolulope', 'Initials': 'T', 'LastName': 'Bella-Awusah', 'Affiliation': 'Centre for Child and Adolescent Mental Health, University of Ibadan, College of Medicine, University College Hospital, Ibadan, Nigeria.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Ani', 'Affiliation': 'Academic Unit of Child and Adolescent Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Ademola', 'Initials': 'A', 'LastName': 'Ajuwon', 'Affiliation': 'Department of Health Promotion and Education, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Olayinka', 'Initials': 'O', 'LastName': 'Omigbodun', 'Affiliation': 'Centre for Child and Adolescent Mental Health, University of Ibadan, College of Medicine, University College Hospital, Ibadan, Nigeria.'}]",Child and adolescent mental health,['10.1111/camh.12104']
3114,32680417,Mitigating depression among orphaned and vulnerable adolescents: a randomized controlled trial of interpersonal psychotherapy for groups in South Africa.,"BACKGROUND


Children and adolescents affected by HIV are at elevated risk of depression, yet research on related interventions in this population is scarce in sub-Saharan Africa. This study sought to examine the effects of interpersonal psychotherapy for groups (IPTG) on depressive symptomology among orphaned and vulnerable adolescents in South Africa.
METHOD


A cluster randomized controlled trial wherein adolescents ages 14-17 enrolled in community-based programming for HIV-affected and vulnerable families were randomly assigned by geographic cluster to participate in a 16-session IPTG intervention or the standard of care (n = 489). Baseline and postintervention surveys conducted with enrollees included standardized depression screening. Utilizing an intent-to-treat design, mixed effects models were performed to examine treatment effects for all participants and potential moderators including gender and baseline depression level (Clinical Trials registration: ClinicalTrials.gov NCT02386878).
RESULTS


While 23% of adolescents in the intervention group did not attend any IPTG sessions, average attendance was 12 out of 16 possible sessions among participants. The intervention was not associated with changes in depression symptomology.
CONCLUSIONS


Results underscore the importance of mitigating participation barriers prior to intervention roll-out and the need for increased evidence for psychological health interventions to mitigate depression among orphaned and vulnerable adolescents. This intervention and the study selectively targeted at-risk adolescents versus using diagnostic mental health criteria for enrollment; more research is needed to identify the potential benefits and disadvantages of these approaches.",2017,"The intervention was not associated with changes in depression symptomology.
","['orphaned and vulnerable adolescents', 'adolescents ages 14-17 enrolled in community-based programming for HIV-affected and vulnerable families', 'groups in South Africa', 'orphaned and vulnerable adolescents in South Africa']","['interpersonal psychotherapy for groups (IPTG', '16-session IPTG intervention or the standard of care', 'interpersonal psychotherapy']","['depressive symptomology', 'depression symptomology']","[{'cui': 'C0242299', 'cui_str': 'Orphan'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.171042,"The intervention was not associated with changes in depression symptomology.
","[{'ForeName': 'Tonya R', 'Initials': 'TR', 'LastName': 'Thurman', 'Affiliation': 'Tulane International LLC, 23 Belmont Road, 7700, Cape Town, South Africa.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Nice', 'Affiliation': 'Tulane School of Social Work, Highly Vulnerable Children Research Center, New Orleans, LA, USA.'}, {'ForeName': 'Tory M', 'Initials': 'TM', 'LastName': 'Taylor', 'Affiliation': 'Tulane School of Social Work, Highly Vulnerable Children Research Center, New Orleans, LA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Luckett', 'Affiliation': 'Tulane School of Social Work, Highly Vulnerable Children Research Center, New Orleans, LA, USA.'}]",Child and adolescent mental health,['10.1111/camh.12241']
3115,32680419,The intersection of adolescent depression and peer violence: baseline results from a randomized controlled trial of 1752 youth in Pakistan.,"BACKGROUND


Depression and peer violence are global issues impacting youth. We are presenting baseline data as part of a cluster randomized control trial underway, on adolescent depression, and associated factors among boys and girls in schools.
METHOD


Cluster randomized control trial is underway for measuring the effectiveness of school-based play intervention program of the NGO Right to Play, in a sample of 1752 grade 6 youth in 40 public schools of Hyderabad, Pakistan. Students responded to Child Depression Inventory (CDI-2), the Peer Victimization Scale (PVS), the Peer Perpetration Scale (PPS), and investigator-driven seven-item School Performance Scale.
RESULTS


We report baseline assessments to examine the prevalence of depressive symptoms, and associated occurrence of peer perpetration and victimization. Boys report significantly more depressive symptoms as well as perpetration and victimization compared to girls (p ≤ .0001). Our analysis indicates that among boys, depression was found associated with greater age, food insecurity, poorer school performance and working for money, as well as being beaten at home and witnessing beating of their mother by their father or other relatives. Among girls, depression was associated with a younger age, greater food insecurity and poorer school performance. Depression was also associated with a great likelihood of engagement in peer violence, experience of punishment at home, and witnessing their father fighting with other men or beating their mother.
CONCLUSIONS


Engagement in violent behaviors, exposure to violent acts and poverty surfaces as detrimental to mental health in youth age groups, suggesting strong measures to address youth violence, and poverty reduction for positive mental health outcomes in school age children.",2017,Boys report significantly more depressive symptoms as well as perpetration and victimization compared to girls (p ≤ .0001).,"['boys and girls in schools', 'school age children', '1752 grade 6 youth in 40 public schools of Hyderabad, Pakistan', '1752 youth in Pakistan']",['school-based play intervention program of the NGO'],"['Child Depression Inventory (CDI-2), the Peer Victimization Scale (PVS), the Peer Perpetration Scale (PPS), and investigator-driven seven-item School Performance Scale', 'depressive symptoms']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0535244,Boys report significantly more depressive symptoms as well as perpetration and victimization compared to girls (p ≤ .0001).,"[{'ForeName': 'Nargis', 'Initials': 'N', 'LastName': 'Asad', 'Affiliation': 'Department of Psychiatry, The Aga Khan University, Karachi, 3500, Pakistan.'}, {'ForeName': 'Rozina', 'Initials': 'R', 'LastName': 'Karmaliani', 'Affiliation': 'School of Nursing & Midwifery, The Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'McFarlane', 'Affiliation': ""College of Nursing, Texas Woman's University, Houston, TX, USA.""}, {'ForeName': 'Shireen Shehzad', 'Initials': 'SS', 'LastName': 'Bhamani', 'Affiliation': 'School of Nursing & Midwifery, The Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Somani', 'Affiliation': 'School of Nursing & Midwifery, The Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Esnat', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'South African Medical Research Council, Pretoria, South Africa.'}]",Child and adolescent mental health,['10.1111/camh.12249']
3116,32679021,The JPJDF has Synergistic Effect with Fluoropyrimidine in the Maintenance Therapy for Metastatic Colorectal Cancer.,"BACKGROUND


Maintenance chemotherapeutic regimen with low toxicity is needed for metastatic colorectal cancer. A recent patent has been issued to the spleen-strengthening and detoxification prescription (JPJDF), a traditional Chinese herbal medicinal formula with anti-angiogenesis effect. The clinical effect of JPJDF on the maintenance treatment of advanced colorectal cancer has not been evaluated.
OBJECTIVE


This study aims to evaluate the effectiveness and safety of JPJDF in combination with fluoropyrimidine compared to fluoropyrimidine alone as maintenance therapy for metastatic colorectal cancer.
METHODS


We applied a prospective, randomized, double-blinded, single center clinical study. A total of 137 patients with advanced colorectal cancer were recruited. .Patients received either Fluoropyrimidine (Flu-treated group, n = 68), or Fluoropyrimidine plus JPJDF (Flu-F-treated group, n=69) as maintenance treatment after 6-cycle of FOLFOX4 or FOLFORI induction treatment. The primary endpoints were Progression-Free Survival (PFS) and Overall Survival (OS). The secondary endpoints were safety, Performance Status (PS) score and other symptoms.
RESULTS


The endpoint of disease progression was observed in 91.7% of patients. The PFS was 5.0 months and 3.0 months in the Flu-F-treated and Flu-treated groups, respectively. The OS was 15.0 months and 9.0 months in the Flu-F-treated and Flu-treated groups, respectively. Some common symptoms, such as hypodynamia, anepithymia, dizziness and tinnitus and shortness of breath, were improved in the Flu-F-treated group. There was no significant difference in the common adverse reactions between the two groups.
CONCLUSION


JPJDF and fluoropyrimidine has synergistic effect in the maintenance treatment of mCRC.",2020,"There was no significant difference in the common adverse reactions between the two groups.
","['137 patients with advanced colorectal cancer', 'metastatic colorectal cancer', 'Metastatic Colorectal Cancer', 'advanced colorectal cancer']","['Fluoropyrimidine (Flu-treated group, n = 68), or Fluoropyrimidine plus JPJDF', 'Fluoropyrimidine', 'JPJDF and fluoropyrimidine', 'fluoropyrimidine', 'fluoropyrimidine alone', 'JPJDF', 'FOLFOX4 or FOLFORI induction treatment']","['disease progression', 'safety, Performance Status (PS) score and other symptoms', 'Progression-Free Survival (PFS) and Overall Survival (OS', 'hypodynamia, anepithymia, dizziness and tinnitus and shortness of breath', 'common adverse reactions']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242684', 'cui_str': 'Hypodynamia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",137.0,0.0636774,"There was no significant difference in the common adverse reactions between the two groups.
","[{'ForeName': 'XiaoLing', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110, Ganhe Road, Shanghai 200437. China.'}, {'ForeName': 'YanBo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'DengCheng', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'NingNing', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'HuaYue', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110, Ganhe Road, Shanghai 200437. China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'ZhiFen', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110, Ganhe Road, Shanghai 200437. China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, No. 528, Zhangheng Road, Shanghai 201203. China.'}]",Recent patents on anti-cancer drug discovery,['10.2174/1574892815666200717141205']
3117,32679040,"Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial.","BACKGROUND


Functional gastrointestinal disorders are common and costly to the health-care system. Most specialist care is provided by a gastroenterologist, but only a minority of patients have improvement in symptoms. Although they have proven to be effective, psychological, behavioural, and dietary therapies are not provided routinely. We aimed to compare the outcome of gastroenterologist-only standard care with multidisciplinary care.
METHODS


In an open-label, single-centre, pragmatic trial, consecutive new referrals of eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders were randomly assigned (1:2) to receive gastroenterologist-only standard care or multidisciplinary clinic care. The multidisciplinary clinic included gastroenterologists, dietitians, gut-focused hypnotherapists, psychiatrists, and behavioural (biofeedback) physiotherapists. Randomisation was stratified by Rome IV disorder and whether referred from gastroenterology or colorectal clinic. Outcomes were assessed at clinic discharge or 9 months after the initial visit. The primary outcome was a score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement. Modified intention-to-treat analysis included all patients who attended at least one clinic visit and who had answered the primary outcome question. This study is registered with ClinicalTrials.gov, NCT03078634.
FINDINGS


Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188 were randomly assigned to receive either standard care (n=65) or multidisciplinary care (n=123). 144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women. 61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians. 26 (57%) patients in the standard-care group and 82 (84%) patients in the multidisciplinary-care group had global symptom improvement (risk ratio 1·50 [95% CI 1·13-1·93]; p=0·00045). 29 (63%) patients in the standard-care group and 81 (83%) patients in the multidisciplinary-care group had adequate relief of symptoms in the past 7 days (p=0·010). Patients in the multidisciplinary-care group were more likely to experience a 50% or higher reduction in all Gastrointestinal Symptom Severity Index symptom clusters than were patients in the standard-care group. Of the patients with irritable bowel syndrome, a 50-point or higher reduction in IBS-SSS occurred in 10 (38%) of 26 patients in the standard care group compared with 39 (66%) of 59 patients in the multidisciplinary-care group (p=0·017). Of the patients with functional dyspepsia, a 50% reduction in the Nepean Dyspepsia Index was noted in three (11%) of 11 patients in the standard-care group and in 13 (46%) of 28 in the multidisciplinary-care group (p=0·47). After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087). The eight SF-36 scales did not differ between the groups at discharge. After treatment, median Somatic Symptom Scale-8 score was higher in the standard-care group than in the multidisciplinary-care group (10 [IQR 7-7] vs 9 [5-13]; p=0·082). Cost per successful outcome was higher in the standard-care group than the multidisciplinary-care group.
INTERPRETATION


Integrated multidisciplinary clinical care appears to be superior to gastroenterologist-only care in relation to symptoms, specific functional disorders, psychological state, quality of life, and cost of care for the treatment of functional gastrointestinal disorders. Consideration should be given to providing multidisciplinary care for patients with a functional gastrointestinal disorder.
FUNDING


None.",2020,"After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087).","['patients with irritable bowel syndrome', 'patients who attended at least one clinic visit and who had answered the primary outcome question', '144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women', 'patients with a functional gastrointestinal disorder', '61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians', 'Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188', 'eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders', 'functional gastrointestinal disorders (MANTRA']","['gastroenterologist-only standard care or multidisciplinary clinic care', 'standard care (n=65) or multidisciplinary care', 'gastroenterologist-only standard care with multidisciplinary care', 'Standard gastroenterologist versus multidisciplinary treatment']","['global symptom improvement (risk ratio 1·50', 'IBS-SSS', 'median EQ-5D-5L quality of life visual analogue scale', 'Gastrointestinal Symptom Severity Index symptom clusters', 'Cost per successful outcome', 'eight SF-36 scales', 'median Somatic Symptom Scale-8 score', 'Nepean Dyspepsia Index', 'adequate relief of symptoms', 'score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement', 'median HADS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0559031', 'cui_str': 'Functional disorder of gastrointestinal tract'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",1632.0,0.109724,"After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087).","[{'ForeName': 'Chamara', 'Initials': 'C', 'LastName': 'Basnayake', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kamm', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia. Electronic address: mkamm@unimelb.edu.au.""}, {'ForeName': 'Annalise', 'Initials': 'A', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': ""Wilson-O'Brien"", 'Affiliation': ""Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Burrell', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Lees-Trinca', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Khera', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kantidakis', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wong', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Salzberg', 'Affiliation': ""Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Thompson', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30215-6']
3118,32679045,Predictors of severe pain during insertion of the levonorgestrel 52 mg intrauterine system among nulligravid women.,"OBJECTIVE


To identify sociodemographic and clinical variables associated with severe pain with levonorgestrel 52mg intrauterine system (IUS) placement among nulligravid women. Study design We performed a secondary analysis of a randomized trial that evaluated intracervical anesthesia before IUS insertion. We assessed factors associated with severe pain (visual analog scale pain score ≥ 7) immediately after insertion using bivariate and multiple regression analyses.
RESULTS


Overall, 137/300 (45.7%) subjects reported severe pain. In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95%CI 1.08-1.72)] were associated with severe pain.
CONCLUSIONS


Among nulligravid women, a history of dysmenorrhea increases, and intracervical block decreases severe pain during levonorgestrel IUS insertion.
IMPLICATIONS


Dysmenorrhea increases the risk of severe pain at levonorgestrel intrauterine system insertion, while receiving an intracervical lidocaine block decreases this risk. This information can be useful for counseling women prior to device placement and for selecting candidates who may particularly benefit from interventions to reduce pain.",2020,"In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95%CI 1.08-1.72)] were associated with severe pain.
",['nulligravid women'],"['lidocaine block', 'levonorgestrel 52mg intrauterine system (IUS) placement', 'levonorgestrel']","['severe pain', 'history of dysmenorrhea', 'severe pain (visual analog scale pain score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0937459', 'cui_str': 'Levonorgestrel 833 nanogram/hour prolonged-release intrauterine drug delivery system'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0475168', 'cui_str': 'H/O: dysmenorrhea'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",,0.301743,"In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95%CI 1.08-1.72)] were associated with severe pain.
","[{'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Sanchez Ferreira', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo. Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Nunes de Nadai', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo. Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Omero B', 'Initials': 'OB', 'LastName': 'Poli-Neto', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo. Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Silvio A', 'Initials': 'SA', 'LastName': 'Franceschini', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo. Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Cássia', 'Initials': 'C', 'LastName': 'Rt Juliato', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Science, University of Campinas, Caixa Postal 6181, CEP 13084-971, Campinas, SP, Brazil.'}, {'ForeName': 'Ilza', 'Initials': 'I', 'LastName': 'Maria U Monteiro', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Science, University of Campinas, Caixa Postal 6181, CEP 13084-971, Campinas, SP, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bahamondes', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Science, University of Campinas, Caixa Postal 6181, CEP 13084-971, Campinas, SP, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sales Vieira', 'Affiliation': 'Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo. Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil. Electronic address: carol.sales@uol.com.br.'}]",Contraception,['10.1016/j.contraception.2020.07.004']
3119,32679866,The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients with Burn: A Prospective Randomized Single-Blind Study.,"We performed pulmonary function (PF) tests and factors affecting PF evaluation in 120 patients with inhalation injury to evaluate the effects of pulmonary rehabilitation (PR) in burn patients with inhalation injury. Patients were randomized into pulmonary rehabilitation (PR) group and conventional rehabilitation (CON) group. PF tests, including forced vital capacity (FVC), 1-s forced expiratory volume FEV1), maximum voluntary ventilation (MVV), and respiratory muscles strength (maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP)), were measured by mouth pressure meter in the sitting position. Diffusing capacity for carbon monoxide (DLco) was determined by the single-breath carbon monoxide technique. Peak cough flow (PCF) was measured by a peak flow meter. Diaphragmatic mobility (DM) was evaluated on anteroposterior fluoroscopy. All evaluations were performed in all groups at baseline and after 12 weeks. There were no differences in evaluations between the PR group and CON group before the intervention. There were significant improvements in the PCF and MIP (%) changes, taken before and after rehabilitation in the PR group, compared with the changes in the CON group ( p  = 0.01, and  p  = 0.04). There were no significant changes in the other parameters in the PR group compared with the changes in the CON group ( p  > 0.05). There were significant differences in DLco (%), MIP, MIP (%), and DM between the PR group and the CON group ( p  = 0.02,  p  = 0.005, and  p  = 0.001) after 12 weeks of rehabilitation. There were no differences between the PR group and CON group after 12 weeks rehabilitation in the other parameters ( p  > 0.05). PR for patients with major burns and smoke inhalation induced improved PCF, MIP, MIP (%), DLco (%), and DM. These results show that PR should be a fundamental component of the treatment program for patients with burns.",2020,There were no differences between the PR group and CON group after 12 weeks rehabilitation in the other parameters ( p  > 0.05).,"['patients with major burns and smoke inhalation', '120 patients with inhalation injury', 'Patients with Burn', 'burn patients with inhalation injury', 'patients with burns']","['pulmonary rehabilitation (PR) group and conventional rehabilitation (CON', 'CON', 'pulmonary rehabilitation (PR', 'Pulmonary Rehabilitation']","['forced vital capacity (FVC', 'Lung Function and Exercise Capacity', 'Diaphragmatic mobility (DM', 'PCF, MIP, MIP (%), DLco (%), and DM', 'PCF and MIP', 'mouth pressure meter in the sitting position', '1-s forced expiratory volume FEV1), maximum voluntary ventilation (MVV), and respiratory muscles strength (maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP', 'Peak cough flow (PCF', 'DLco (%), MIP, MIP (%), and DM', 'Diffusing capacity for carbon monoxide (DLco']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0037367', 'cui_str': 'Smoke inhalation injury'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0745334', 'cui_str': 'Inhalation injury'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280474', 'cui_str': 'Transfer factor (respiratory measure)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",120.0,0.0139461,There were no differences between the PR group and CON group after 12 weeks rehabilitation in the other parameters ( p  > 0.05).,"[{'ForeName': 'Yu Hui', 'Initials': 'YH', 'LastName': 'Won', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju 54907 Korea.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, 94-200 Yeongdeungpo-Dong Yeongdeungpo-Ku, Seoul 07247, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, 94-200 Yeongdeungpo-Dong Yeongdeungpo-Ku, Seoul 07247, Korea.'}, {'ForeName': 'Cheong Hoon', 'Initials': 'CH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, 94-200 Yeongdeungpo-Dong Yeongdeungpo-Ku, Seoul 07247, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9072250']
3120,32680067,Random phase-shifting digital holography based on a self-calibrated system.,"Random phase-shifting digital holography based on a self-calibrated system is proposed. In the proposed method, the hologram and the calibration interference fringes can be recorded simultaneously in a single image based on the space-division-multiplexing technique. Three randomly phase-shifted holograms and corresponding interference fringes are recorded, and the phase-shifting amount between each two adjacent holograms is calculated by the sampling Moiré method from the calibration interference fringes. A reflective object is used to demonstrate the effectiveness of the proposed method in the numerical and experiment.",2020,"In the proposed method, the hologram and the calibration interference fringes can be recorded simultaneously in a single image based on the space-division-multiplexing technique.",[],[],[],[],[],[],3.0,0.0128143,"In the proposed method, the hologram and the calibration interference fringes can be recorded simultaneously in a single image based on the space-division-multiplexing technique.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Shien', 'Initials': 'S', 'LastName': 'Ri', 'Affiliation': ''}]",Optics express,['10.1364/OE.395819']
3121,32680328,Taming the adolescent mind: a randomised controlled trial examining clinical efficacy of an adolescent mindfulness-based group programme.,"BACKGROUND


Mindfulness interventions with adolescents are in the early stages of development. This study sought to establish efficacy of a mindfulness-based group intervention for adolescents with mixed mental health disorders.
METHOD


One hundred and eight adolescents (ages 13-18) were recruited from community mental health clinics and randomised into two groups (control vs. treatment). All participants received treatment-as-usual (TAU) from clinic-based therapists independent of the study. Adolescents in the treatment condition received TAU plus a 5-week mindfulness-training programme (TAU+Mi); adolescents in the control group received only TAU. Assessments including parent/carer reports were conducted at baseline, postintervention and 3-month follow-up.
RESULTS


At postintervention, adolescents in the mindfulness condition experienced significant decrease in mental distress (measured with the DASS-21) compared to the control group (Cohen's d = 0.43), and these gains were enhanced at 3-month follow-up (Cohen's d = 0.78). Overall outcomes at 3 months showed significant improvement for adolescents in the mindfulness condition; in self-esteem, mindfulness, psychological inflexibility and mental health, but not resilience. Parents/carers also reported significant improvement in their adolescent's psychological functioning (using the CBCL). Mediation analyses concluded mindfulness mediated mental health outcomes.
CONCLUSIONS


Increase in mindful awareness after training leads to improvement in mental health and this is consistent with mindfulness theory. The mindfulness group programme appears to be a promising adjunctive therapeutic approach for clinic-based adolescents with mental health problems.",2015,"Overall outcomes at 3 months showed significant improvement for adolescents in the mindfulness condition; in self-esteem, mindfulness, psychological inflexibility and mental health, but not resilience.","['adolescents with mixed mental health disorders', 'clinic-based adolescents with mental health problems', 'One hundred and eight adolescents (ages 13-18) were recruited from community mental health clinics']","['mindfulness-based group intervention', 'adolescent mindfulness-based group programme', 'TAU plus a 5-week mindfulness-training programme (TAU+Mi); adolescents in the control group received only TAU']","['mental distress', ""adolescent's psychological functioning"", 'self-esteem, mindfulness, psychological inflexibility and mental health']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0235109', 'cui_str': 'Mental distress'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",108.0,0.0333644,"Overall outcomes at 3 months showed significant improvement for adolescents in the mindfulness condition; in self-esteem, mindfulness, psychological inflexibility and mental health, but not resilience.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry, Principal Clinical Psychologist, Tan Psychological Services, RBWH, Herston Rd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Martin', 'Affiliation': 'Psychiatry, The University of Queensland, Brisbane, Queensland, Australia.'}]",Child and adolescent mental health,['10.1111/camh.12057']
3122,32680330,"A controlled evaluation of the 'FRIENDS for Life' emotional resiliency programme on overall anxiety levels, anxiety subtype levels and school adjustment.","BACKGROUND


Anxiety constitutes the most common form of psychopathology in childhood and adolescence.
METHODS


This randomised controlled study evaluated the 'FRIENDS for Life' school-based Cognitive Behavioural Therapy programme on overall anxiety, anxiety subtypes and school adjustment. Sixty-two students aged 12-13 completed measures of anxiety and school adjustment before, immediately after and 4 months after completing the programme. Parents and teachers also rated the students on overall anxiety levels and school adjustment respectively.
RESULTS


The intervention group's 'overall anxiety' and specifically 'separation anxiety' reduced significantly during the programme and continued to decrease at the 4-month follow-up.
CONCLUSIONS


A significant negative correlation was found between anxiety and school adjustment. The professional implications of these findings are discussed.",2015,"The intervention group's 'overall anxiety' and specifically 'separation anxiety' reduced significantly during the programme and continued to decrease at the 4-month follow-up.
","['Sixty-two students aged 12-13 completed measures of anxiety and school adjustment before, immediately after and 4\xa0months after completing the programme']",['Cognitive Behavioural Therapy programme'],"['overall anxiety levels, anxiety subtype levels and school adjustment', 'overall anxiety levels and school adjustment respectively', ""overall anxiety' and specifically 'separation anxiety"", 'overall anxiety, anxiety subtypes and school adjustment']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0003477', 'cui_str': 'Separation anxiety'}]",62.0,0.0251054,"The intervention group's 'overall anxiety' and specifically 'separation anxiety' reduced significantly during the programme and continued to decrease at the 4-month follow-up.
","[{'ForeName': 'Alish', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'National Behaviour Support Service, Navan Education Centre, Navan, Ireland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dunsmuir', 'Affiliation': 'University College London, London, UK.'}]",Child and adolescent mental health,['10.1111/camh.12030']
3123,32680337,Innovations in Practice: a pilot study of interpersonal psychotherapy for depressed adolescents and their parents.,"BACKGROUND


Problems in adolescents' relationships with their parents are a significant risk factor for the development and maintenance of depression. The purpose of this pilot study was to examine the feasibility and acceptability of an adaptation of interpersonal psychotherapy for depressed adolescents (IPT-A) who were also experiencing problems in their relationships with parents. The adaptation includes greater and more structured parent involvement in the treatment (IPT-AP).
METHOD


Fifteen adolescents (age 12-17) who were diagnosed with depression and were also experiencing conflictual or emotionally disengaged relationships with their parents (based on adolescent or parent report on the Conflict Behavior Questionnaire) participated in a 16 week randomized clinical trial of individually delivered IPT-A versus IPT-AP. Data regarding the feasibility and acceptability of IPT-AP were collected. Assessments of depression and family functioning were completed at baseline and weeks 4, 8, 12, and 16 by evaluators blind to treatment condition.
RESULTS


IPT-AP was feasible to implement, and adolescents and parents reported high treatment satisfaction. Adolescents demonstrated significant improvements in depressive symptoms, general functioning, and family functioning. IPT-AP was more efficacious than individual IPT-A in improving adolescents' perceptions of father-adolescent relations and mothers' perceptions of mother-adolescent relations.
CONCLUSIONS


Interpersonal psychotherapy for depressed adolescents and their parents was feasible to implement and acceptable to families, indicating that a full-scale randomized controlled trial to evaluate its efficacy is warranted.",2016,"IPT-AP was more efficacious than individual IPT-A in improving adolescents' perceptions of father-adolescent relations and mothers' perceptions of mother-adolescent relations.
","['depressed adolescents (IPT-A) who were also experiencing problems in their relationships with parents', 'depressed adolescents and their parents', 'Fifteen adolescents (age 12-17) who were diagnosed with depression and were also experiencing conflictual or emotionally disengaged relationships with their parents (based on adolescent or parent report on the Conflict Behavior Questionnaire) participated in a 16\xa0week randomized clinical trial of individually delivered']","['IPT-A versus IPT-AP', 'IPT-AP', 'Interpersonal psychotherapy', 'interpersonal psychotherapy']","['feasibility and acceptability', 'depressive symptoms, general functioning, and family functioning', 'depression and family functioning']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0529785,"IPT-AP was more efficacious than individual IPT-A in improving adolescents' perceptions of father-adolescent relations and mothers' perceptions of mother-adolescent relations.
","[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Gunlicks-Stoessel', 'Affiliation': 'Department of Psychiatry, University of Minnesota, 2450 Riverside Ave, F256/2B West, Minneapolis, MN, 55454, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mufson', 'Affiliation': 'Division of Child & Adolescent Psychiatry, New York State Psychiatric Institute, Columbia University, New York City, NY, USA.'}]",Child and adolescent mental health,['10.1111/camh.12167']
3124,32680441,A Digital Lifestyle Program in Outpatient Treatment of Type 2 Diabetes: A Randomized Controlled Study.,"BACKGROUND


Lifestyle is important in type 2 diabetes mellitus (T2DM). This study's aim was to investigate whether a healthy-lifestyle-supporting smartphone application could affect treatment outcomes at an endocrinology outpatient clinic.
METHODS


Consecutively invited patients were randomly assigned to an intervention or control group after age and gender stratification. In addition to standard care, intervention group participants used a smartphone application to access a lifestyle program (SidekickHealth) through which they received personalized recommendations and education about healthy lifestyles. Tests at baseline and every other month for six months included body weight and blood tests for glycated hemoglobin (HbA1c) and blood lipids, as well as questionnaires about distress related to diabetes, health-related quality of life, depression, and anxiety. Statistics included comparisons both within and between groups.
RESULTS


A total of 37 patients (23 women) were included, whereof 30 finished, 15 in each group (19% dropout); the average age was 51.2 ± 10.6 (25-70) years. No significant differences emerged between groups, but within the intervention group, there was a significant decrease in HbA1c from 61 ± 21.4 to 52.7 ± 15.2 mmol/mol, in disease-specific distress from 19.5 ± 16.5 to 11.7 ± 13.4, and in anxiety symptoms from 5.4 ± 4.0 to 4.1 ± 3.8. No significant changes occurred within the control group. The application usage was most frequent during the first months and differed interpersonally.
CONCLUSIONS


Our results indicate that the SidekickHealth digital lifestyle program could potentially enhance outpatient treatment in T2DM, in terms of both glycemic control and psychological well-being but larger confirmative studies are needed.",2020,"No significant differences emerged between groups, but within the intervention group, there was a significant decrease in HbA1c from 61 ± 21.4 to 52.7 ± 15.2 mmol/mol, in disease-specific distress from 19.5 ± 16.5 to 11.7 ± 13.4, and in anxiety symptoms from 5.4 ± 4.0 to 4.1 ± 3.8.","['Consecutively invited patients', 'Diabetes', '37 patients (23 women) were included, whereof 30 finished, 15 in each group (19% dropout); the average age was 51.2 ± 10.6 (25-70) years', 'Outpatient Treatment of Type 2', 'type 2 diabetes mellitus (T2DM']","['Digital Lifestyle Program', 'SidekickHealth digital lifestyle program', 'smartphone application to access a lifestyle program (SidekickHealth) through which they received personalized recommendations and education about healthy lifestyles', 'healthy-lifestyle-supporting smartphone application']","['body weight and blood tests for glycated hemoglobin (HbA1c) and blood lipids, as well as questionnaires about distress related to diabetes, health-related quality of life, depression, and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",37.0,0.0305089,"No significant differences emerged between groups, but within the intervention group, there was a significant decrease in HbA1c from 61 ± 21.4 to 52.7 ± 15.2 mmol/mol, in disease-specific distress from 19.5 ± 16.5 to 11.7 ± 13.4, and in anxiety symptoms from 5.4 ± 4.0 to 4.1 ± 3.8.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hilmarsdóttir', 'Affiliation': 'School of Health Sciences, University of Akureyri, Iceland.'}, {'ForeName': 'Árún K', 'Initials': 'ÁK', 'LastName': 'Sigurðardóttir', 'Affiliation': 'School of Health Sciences, University of Akureyri, Iceland.'}, {'ForeName': 'Ragnheiður Harpa', 'Initials': 'RH', 'LastName': 'Arnardóttir', 'Affiliation': 'School of Health Sciences, University of Akureyri, Iceland.'}]",Journal of diabetes science and technology,['10.1177/1932296820942286']
3125,32680456,A randomised crossover comparison of two endotracheal tube introducers: the FROVA and the Flexible Tip Bougie for GlideScope intubation of a difficult airway manikin by infrequent intubators.,"BACKGROUND


This unblinded randomised crossover study compares two endotracheal tube introducers (ETIs): the FROVA and the ""Flexible Tip Bougie"" (FTB), in an airway manikin mimicking difficult intubation with a percentage of glottic opening view of 30%. Participants were Emergency Medicine and Anaesthesia trainees with recent experience of less than twenty patient intubations. The primary outcome was time to intubation, further divided into time taken to pass the ETI and time to railroad the endotracheal tube (ETT) over the ETI. The secondary outcome was the difficulty of intubation.
RESULTS


The median total time to ETT placement was significantly shorter with the FTB (37.5 s) compared with the FROVA ETI (63.0 s), P = 0.0006. The median difficulty reported (scores 0-10 with 0 being no difficulty) with the FTB was 2 compared with 5 for the FROVA, P < 0.0001.
CONCLUSIONS


The FTB enabled significantly faster and easier placement of the endotracheal tube compared with the FROVA in inexperienced hands intubating a difficult intubation manikin.",2020,The FTB enabled significantly faster and easier placement of the endotracheal tube compared with the FROVA in inexperienced hands intubating a difficult intubation manikin.,['Participants were Emergency Medicine and Anaesthesia trainees with recent experience of less than twenty patient intubations'],"['endotracheal tube introducers (ETIs', 'FTB', 'Flexible Tip Bougie"" (FTB', 'FROVA', 'endotracheal tube introducers: the FROVA and the Flexible Tip']","['median total time to ETT placement', 'time to intubation, further divided into time taken to pass the ETI and time to railroad the endotracheal tube (ETT) over the ETI', 'difficulty of intubation']","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0179390', 'cui_str': 'Bougie'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C1099778', 'cui_str': 'Frova'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034638', 'cui_str': 'Railroads'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.0429303,The FTB enabled significantly faster and easier placement of the endotracheal tube compared with the FROVA in inexperienced hands intubating a difficult intubation manikin.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cormack', 'Affiliation': 'The Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Building 181, Grattan St, Melbourne, 3010, Australia. cormackj@ozemail.com.au.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Langley', 'Affiliation': 'The Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Building 181, Grattan St, Melbourne, 3010, Australia.'}, {'ForeName': 'Louisa-Rose', 'Initials': 'LR', 'LastName': 'Bhanabhai', 'Affiliation': ""Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital Melbourne, 41 Victoria Parade, PO Box 2900, Fitzroy, VIC 3065, Australia.""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kluger', 'Affiliation': 'The Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Building 181, Grattan St, Melbourne, 3010, Australia.'}]",International journal of emergency medicine,['10.1186/s12245-020-00298-6']
3126,32680465,Study protocol: older people in retirement villages. A survey and randomised trial of a multi-disciplinary invention designed to avoid adverse outcomes.,"BACKGROUND


There is increasing interest among older people in moving into retirement villages (RVs), an attractive option for those seeking a supportive community as they age, while still maintaining independence. Currently in New Zealand there is limited knowledge of the medical, service supports, social status and needs of RV residents. The objective of this study is to explore RV facilities and services, the health and functional status of RV residents, prospectively study their healthcare trajectories and to implement a multidisciplinary team intervention to potentially decrease dependency and impact healthcare utilization.
METHODS


All RVs located in two large district health boards in Auckland, New Zealand were eligible to participate. This three-year project comprised three phases: The survey phase provided a description of RVs, residents' characteristics and health and functional status. RV managers completed a survey of size, facilities and recreational and healthcare services provided in the village. Residents were surveyed to establish reasons for entry to the village and underwent a Gerontology Nurse Specialist (GNS) assessment providing details of demographics, social engagement, health and functional status. The cohort study phase examines residents' healthcare trajectories and adverse outcomes, over three years. The final phase is a randomised controlled trial of a multidisciplinary team intervention aimed to improve health outcomes for more vulnerable residents. Residents who triggered potential unmet health needs during the assessment in the survey phase were randomised to intervention or usual care groups. Multidisciplinary team meetings included the resident and support person, a geriatrician or gerontology nurse practitioner, GNS, pharmacist and General Practitioner. The primary outcome of the randomised controlled trial will be first acute hospitalization. Secondary outcomes include all acute hospitalizations, long-term care admissions, and all-cause mortality.
DISCUSSION


This paper describes the study protocol of this complex study. The study aims to inform policies and practices around health care services for residents in retirement villages. The results of this trial are expected early 2020 with publication subsequently.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Registry: ACTRN12616000685415 . Registered 25.5.2016. Universal Trial Number (UTN): U111-1173-6083.",2020,The final phase is a randomised controlled trial of a multidisciplinary team intervention aimed to improve health outcomes for more vulnerable residents.,"['Study protocol: older people in retirement villages', 'Residents were surveyed to establish reasons for entry to the village and underwent a Gerontology Nurse Specialist (GNS) assessment providing details of demographics, social engagement, health and functional status', 'All RVs located in two large district health boards in Auckland, New Zealand were eligible to participate', 'more vulnerable residents', 'residents in retirement villages', 'older people in moving into retirement villages (RVs', 'Residents who triggered potential unmet health needs during the assessment in the survey phase']",['multi-disciplinary invention'],"['acute hospitalizations, long-term care admissions, and all-cause mortality', 'health outcomes']","[{'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C4277711', 'cui_str': 'Nurse Specialists'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C1273868', 'cui_str': 'Health needs (community)'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3494260', 'cui_str': 'Inventions'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.127928,The final phase is a randomised controlled trial of a multidisciplinary team intervention aimed to improve health outcomes for more vulnerable residents.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peri', 'Affiliation': 'School of Nursing, University of Auckland, Private Bag 92 019, Auckland, 1142, New Zealand.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Broad', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Level 1, Building 5, Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hikaka', 'Affiliation': 'Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'School of Nursing, University of Auckland, Private Bag 92 019, Auckland, 1142, New Zealand.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Level 1, Building 5, Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Level 1, Building 5, Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Calvert', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Level 1, Building 5, Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tatton', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Level 1, Building 5, Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Higgins', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Level 1, Building 5, Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bramley', 'Affiliation': 'Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Level 1, Building 5, Waitemata District Health Board, PO Box 93 503, Auckland, Takapuna, 0740, New Zealand. martin.connolly@waitematadhb.govt.nz.'}]",BMC geriatrics,['10.1186/s12877-020-01640-6']
3127,32680475,Impact of a smoking cessation program on smoking prevalence and food security among food pantry users - a study protocol for a pragmatic cluster randomised controlled trial.,"BACKGROUND


Among food pantry users there is a high prevalence of both smoking and food insecurity, which may be related to one another. This study aims to evaluate the impact of a smoking cessation program carried out in food pantries on the smoking status and the food security status of food pantry users.
METHODS / DESIGN


Before starting the cluster randomised controlled trial, stakeholders will be engaged to adapt a behavioural group counselling program for smoking cessation to the needs of the food pantry users in a pre study. Food pantry users and workers as well as other experts, such as smoking cessation trainers, social workers, and psychologists, will be involved, using the world café technique and telephone interviews and a qualitative thematic analysis for data analysis to design the concept of the intervention program will be applied. In the second phase, the impact of the intervention on the smoking status and on food insecurity will be investigated by a cluster randomised controlled trial. A total of 416 food pantry users across 32 clusters (food pantries) in Berlin, Germany, should be recruited and randomly assigned to either the intervention group or the waiting list control group. The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries. The primary outcomes 6 months after the treatment will be self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10 ppm of carbon monoxide), and increased food security level (the percentage of participants with an improved food security level).
DISCUSSION


This study will be the first long-term investigation into the effect of a smoking cessation program on smoking status and food insecurity. The results of this study will inform the implementation of smoking cessation programs in food pantries throughout Germany.
TRIAL REGISTRATION


Prospectively registered DRKS00020037 . Registered 29 April 2020.",2020,"The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries.","['416 food pantry users across 32 clusters (food pantries) in Berlin, Germany']","['behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy', 'smoking cessation program', 'behavioural group counselling program', 'waiting list control group']","['smoking prevalence and food security', 'self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10\u2009ppm of carbon monoxide), and increased food security level']","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0554824,"The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Simmet', 'Affiliation': 'Institute of Nutritional Medicine, Department of Nutritional Psychology, University of Hohenheim, Fruwirthstr. 12, 70593, Stuttgart, Germany. Anja.Simmet@uni-hohenheim.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Teut', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Luisenstraße 57, 10117, Berlin, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Schleicher', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Luisenstraße 57, 10117, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bschaden', 'Affiliation': 'Institute of Nutritional Medicine, Department of Nutritional Psychology, University of Hohenheim, Fruwirthstr. 12, 70593, Stuttgart, Germany.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Stroebele-Benschop', 'Affiliation': 'Institute of Nutritional Medicine, Department of Nutritional Psychology, University of Hohenheim, Fruwirthstr. 12, 70593, Stuttgart, Germany.'}]",BMC public health,['10.1186/s12889-020-09232-0']
3128,32680804,Respiratory Muscle Strength Training to Improve Vocal Function in Patients with Presbyphonia.,"BACKGROUND AND OBJECTIVE


The effects of presbyphonia are compounded by the decline in respiratory function that occurs with age. Commonly recommended exercises to optimize the use of respiratory muscles during speech, such as diaphragmatic breathing, are unlikely to be intensive enough to induce respiratory changes and impact vocal function. The objective of this study was to assess the effect of adding a targeted intervention, respiratory muscle strength training, to voice exercises in a sample of patients with presbyphonia.
METHODS/DESIGN


In this prospective, randomized-controlled trial, 12 participants received either (1) vocal function exercises (VFE), (2) VFE combined with inspiratory muscle strength training (IMST), or (3) VFE combined with expiratory muscle strength training (EMST). Data collected prior to and following 4 weekly intervention sessions included respiratory measures (pulmonary function and respiratory muscle strength) and voice measures (videostroboscopy, acoustic, auditory-perceptual, aerodynamic, and self-assessment measures).
RESULTS


Participants who received IMST improved their voice quality during connected speech (smoothed cepstral peak prominence and ratings of overall voice quality) and their scores on the three self-assessment questionnaires with large to very large within-group effect sizes (|d| = 0.82-1.61). In addition, participants in the IMST group reduced their subglottal pressure with a large effect size (d = -0.92). Participants who received EMST improved their maximum expiratory strength and smoothed cepstral peak prominence with large effect sizes (d = 0.80 and 0.99, respectively) but had limited improvements in other outcomes. Participants who received only VFE decreased their amount of vocal fold bowing, improved their voice quality on a sustained vowel (amplitude perturbation quotient), and improved their Glottal Function Index score with large effect sizes (|d| = 0.74-1.00).
CONCLUSION


Preliminary data indicate that adding IMST to voice exercises may lead to the greatest benefits in patients with presbyphonia by promoting improved subglottal pressure control as well as increasing air available for phonation, resulting in improved self-assessment outcomes.",2020,"Participants who received only VFE decreased their amount of vocal fold bowing, improved their voice quality on a sustained vowel (amplitude perturbation quotient), and improved their Glottal Function Index score with large effect sizes (|d| = 0.74-1.00).
","['patients with presbyphonia', '12 participants received either (1', 'Patients with Presbyphonia']","['targeted intervention, respiratory muscle strength training, to voice exercises', 'IMST', 'EMST', 'VFE', 'presbyphonia', 'vocal function exercises (VFE), (2) VFE combined with inspiratory muscle strength training (IMST), or (3) VFE combined with expiratory muscle strength training (EMST', 'Respiratory Muscle Strength Training']","['voice quality', 'Glottal Function Index score', 'subglottal pressure', 'maximum expiratory strength and smoothed cepstral peak prominence', 'respiratory measures (pulmonary function and respiratory muscle strength) and voice measures (videostroboscopy, acoustic, auditory-perceptual, aerodynamic, and self-assessment measures', 'voice quality during connected speech (smoothed cepstral peak prominence and ratings of overall voice quality', 'subglottal pressure control', 'Vocal Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522372', 'cui_str': 'Senile voice'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0589289', 'cui_str': 'Voice exercises'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C1532868', 'cui_str': 'Vocal function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522372', 'cui_str': 'Senile voice'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429673', 'cui_str': 'Respiratory measure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532868', 'cui_str': 'Vocal function'}]",12.0,0.0313692,"Participants who received only VFE decreased their amount of vocal fold bowing, improved their voice quality on a sustained vowel (amplitude perturbation quotient), and improved their Glottal Function Index score with large effect sizes (|d| = 0.74-1.00).
","[{'ForeName': 'Maude', 'Initials': 'M', 'LastName': 'Desjardins', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Delaware, Newark, Delaware. Electronic address: maude@udel.edu.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Halstead', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Department of Health Sciences and Research, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Flume', 'Affiliation': 'Pulmonary and Critical Care Division, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Heather Shaw', 'Initials': 'HS', 'LastName': 'Bonilha', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina; Department of Health Sciences and Research, Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.06.006']
3129,32680812,The effect of manual lymphatic drainage on patient recovery after orthognathic surgery-A qualitative and 3-dimensional facial analysis.,"OBJECTIVE


The aim of this study was to investigate the effect of manual lymphatic drainage (MLD) on postoperative facial swelling and pain.
STUDY DESIGN


A randomized, single-center, prospective, 2-arm clinical trial with blinded endpoint assessment was set up. Patients were enrolled from the Maxillofacial Department of the Ghent University Hospital (Belgium) between January 2015 and March 2018. Both the intervention group (n = 13) and the control group (n = 13) received the same postoperative care; in addition, the intervention group underwent 6 sessions of MLD after orthognathic surgery. Three-dimensional facial scans were performed and questionnaires administered on postoperative days 3, 7, 14, 30, 90, and 180. A linear mixed model was performed, and statistical significance was assumed at the 5% level.
RESULTS


In total, 26 patients (mean age 29 years; range 16-57 years) were included for statistical analysis. A faster decrease in swelling in the intervention group was observed on 3-dimensional scans. Furthermore, patients receiving MLD reported reduction in swelling and pain within the first month after surgery. However, no statistically significant difference could be detected in these observations (P > .05).
CONCLUSIONS


Within the limitations of this study, no statistically significant difference could be found between patients treated with or without MLD after orthognathic surgery with regard to swelling and pain.",2020,A faster decrease in swelling in the intervention group was observed on 3-dimensional scans.,"['Patients were enrolled from the Maxillofacial Department of the Ghent University Hospital (Belgium) between January 2015 and March 2018', '26 patients (mean age 29 years; range 16-57 years']","['manual lymphatic drainage', 'manual lymphatic drainage (MLD', 'MLD']","['swelling', 'swelling and pain', 'postoperative facial swelling and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}]",26.0,0.0811295,A faster decrease in swelling in the intervention group was observed on 3-dimensional scans.,"[{'ForeName': 'Fréderic E G', 'Initials': 'FEG', 'LastName': 'Van de Velde', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium. Electronic address: Frederic.vandevelde@ugent.be.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Ortega-Castrillon', 'Affiliation': 'Department of Electrical Engineering, ESAT/PSI, KU Leuven, Heverlee, Belgium; Medical Imaging Research Center, MIRC, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Laurent A M', 'Initials': 'LAM', 'LastName': 'Thierens', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Claes', 'Affiliation': ""Department of Electrical Engineering, ESAT/PSI, KU Leuven, Heverlee, Belgium; Medical Imaging Research Center, MIRC, UZ Leuven, Leuven, Belgium; Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'De Pauw', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.05.017']
3130,32680841,A Swedish primary healthcare prevention programme focusing on promotion of physical activity and a healthy lifestyle reduced cardiovascular events and mortality: 22-year follow-up of 5761 study participants and a reference group.,"OBJECTIVE


To evaluate long-term risk of first cardiovascular (CV) events, CV deaths and all-cause deaths in community-dwelling participants of a cardiovascular disease (CVD) prevention programme delivered in a primary care setting.
METHODS


Individuals who visited a primary healthcare service in Sollentuna (Sweden) and agreed to participate in the programme between 1988 and 1993 were followed. They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management. Participants (n=5761) were compared with a randomly selected, propensity score-matched reference group from the general population in Stockholm County (n=34 556). All individuals were followed in Swedish registers until December 2011.
RESULTS


In the intervention group and the reference group there were 698 (12.1%) and 4647 (13.4%) first CV events, 308 (5.3%) and 2261 (6.5%) CV deaths, and 919 (16.5%) and 6405 (18.5%) all-cause deaths, respectively, during a mean follow-up of 22 years. The HR (95% CI) in the intervention group compared with the reference group was 0.88 (0.81 to 0.95) for first CV events, 0.79 (0.70 to 0.89) for CV deaths and 0.83 (0.78 to 0.89) for all-cause deaths.
CONCLUSIONS


Participation in a CVD prevention programme in primary healthcare focusing on promotion of physical activity and healthy lifestyle was associated with lower risk of CV events (12%), CV deaths (21%) and all-cause deaths (17%) after two decades. Promoting physical activity and healthy living in the primary healthcare setting may prevent CVD.",2020,"They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management.","['Participants (n=5761) were compared with a randomly selected, propensity score-matched reference group from the general population in Stockholm County (n=34 556', 'All individuals were followed in Swedish registers until December 2011', 'community-dwelling participants of a cardiovascular disease (CVD) prevention programme delivered in a primary care setting', 'Individuals who visited a primary healthcare service in Sollentuna (Sweden) and agreed to participate in the programme between 1988 and 1993 were followed', '5761 study participants and a reference group']",[],"['risk of CV events', 'cardiovascular events and mortality', 'CV deaths']","[{'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",5761.0,0.0433087,"They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management.","[{'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Journath', 'Affiliation': 'Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden gunilla.journath@ki.se.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Hammar', 'Affiliation': 'Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Vikström', 'Affiliation': 'Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Linnersjö', 'Affiliation': 'Unit of Occupational Medicine, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Walldius', 'Affiliation': 'Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Krakau', 'Affiliation': 'Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lindgren', 'Affiliation': 'Medical Management Center, Department of Learning, Information, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'de Faire', 'Affiliation': 'Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellenius', 'Affiliation': 'Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101749']
3131,32680894,Oncology to specialised palliative home care systematic transition: the Domus randomised trial.,"OBJECTIVES


To assess the effect of a systematic, fast-track transition from oncological treatment to specialised palliative care at home on symptom burden, to explore intervention mechanisms through patient and intervention provider characteristics and to assess long-term survival and place of death.
MEASURES


The effect of a systematic, fast-track transition from oncological treatment to specialised palliative care at home on patient symptom burden was studied in the Domus randomised clinical trial. Participants had incurable cancer and limited treatment options. The intervention was provided by specialised palliative home teams (SPT) based in hospice or hospital and was enriched with a psychological intervention for patient and caregiver dyad. Symptom burden was measured with Edmonton Symptom Assessment System (ESAS-r) at baseline, 8 weeks and 6 months follow-up and analysed with mixed models. Survival and place of death was analysed with Kaplan-Meier and Fisher's exact tests.
RESULTS


The study included 322 patients. Tiredness was significantly improved for the Domus intervention group at 6 months while the other nine symptom outcomes were not significantly different from the control group. Exploring the efficacy of intervention provider demonstrated significant differences in favour of the hospice SPT on four symptoms and total symptom score. Patients with children responded more favourably to the intervention. The long-term follow-up demonstrated no differences between the intervention and the control groups regarding survival or home deaths.
CONCLUSIONS


The Domus intervention may reduce tiredness. Moreover, the intervention provider and having children might play a role concerning intervention efficacy. The intervention did not affect survival or home deaths.
TRIAL REGISTRATION NUMBER


NCT01885637.",2020,Exploring the efficacy of intervention provider demonstrated significant differences in favour of the hospice SPT on four symptoms and total symptom score.,"['Participants had incurable cancer and limited treatment options', 'Patients with children', '322 patients']",['specialised palliative home teams (SPT) based in hospice or hospital and was enriched with a psychological intervention'],"['Tiredness', 'survival or home deaths', 'tiredness', 'Survival and place of death']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517712', 'cui_str': '322'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0421611', 'cui_str': 'Place of death'}]",322.0,0.131257,Exploring the efficacy of intervention provider demonstrated significant differences in favour of the hospice SPT on four symptoms and total symptom score.,"[{'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Benthien', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark kirstine.skov.benthien@regionh.dk.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Diasso', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'von Heymann', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Nordly', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Geana', 'Initials': 'G', 'LastName': 'Kurita', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Timm', 'Affiliation': 'REHPA, The Danish Knowledge Center for Rehabilitation and Palliative Care, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Johansen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kjellberg', 'Affiliation': 'VIVE Health, VIVE-The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'von der Maase', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjøgren', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002325']
3132,32681063,Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery.,"OBJECTIVE


Explore a music therapy (MT) intervention to support infant recovery post retinopathy of prematurity (ROP) exam.
STUDY DESIGN


Prospective, double-masked, randomized, parallel group study of 100 preterm infants exposed to MT (recorded maternal singing/heartbeat) or standard care (SC). Premature Infant Pain Profile (PIPP) measured at: baseline, during the exam, and 1 and 5 min post exam.
RESULTS


Recovery PIPP scores were less with MT vs. SC, but statistical significance not achieved (Mean ± sd: MT 1 min [5.81 ± 2.93] and 5 min [3.91 ± 1.73] vs. SC 1 min [6.40 ± 2.78] and 5 min [4.76 ± 2.07], p = 0.07). Recovery PIPP sores were significantly higher with SC compared to MT when eye exams were longer (p = 0.049) or when exams were more painful (p = 0.04).
CONCLUSION


Recorded maternal singing and heartbeat can support recovery post ROP exam. For longer/more painful ROP exams, MT may be more effective than SC promoting recovery post exam.",2020,"Recovery PIPP sores were significantly higher with SC compared to MT when eye exams were longer (p = 0.049) or when exams were more painful (p = 0.04).
",['100 preterm infants exposed to MT (recorded maternal singing/heartbeat) or standard care (SC'],"['Music therapy and retinopathy of prematurity screening', 'music therapy (MT) intervention']","['Recovery PIPP sores', 'Recovery PIPP scores', 'Premature Infant Pain Profile (PIPP']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.10605,"Recovery PIPP sores were significantly higher with SC compared to MT when eye exams were longer (p = 0.049) or when exams were more painful (p = 0.04).
","[{'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Corrigan', 'Affiliation': 'Orlando Health Winnie Palmer Hospital for Women & Babies, Alexander Center for Neonatology, Orlando, FL, USA. maxwell.corrigan@orlandohealth.com.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Keeler', 'Affiliation': 'Orlando Health Winnie Palmer Hospital for Women & Babies, Alexander Center for Neonatology, Orlando, FL, USA.'}, {'ForeName': 'Harriet D', 'Initials': 'HD', 'LastName': 'Miller', 'Affiliation': 'Orlando Health Winnie Palmer Hospital for Women & Babies, Alexander Center for Neonatology, Orlando, FL, USA.'}, {'ForeName': 'Bertha A', 'Initials': 'BA', 'LastName': 'Ben Khallouq', 'Affiliation': 'Orlando Health Arnold Palmer Hospital for Children, Orlando, FL, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Fowler', 'Affiliation': 'Orlando Health, Center for Nursing Research, Orlando, FL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0719-9']
3133,32679755,Effects of 3D Moving Platform Exercise on Physiological Parameters and Pain in Patients with Chronic Low Back Pain.,"Background and objectives:  Patient-handling activities predispose women to chronic low back pain (CLBP), but sufficient evidence is not available on whether a 3D moving platform, made for core stability exercise, affects pain, trunk flexibility, and static/dynamic muscle contractions in CLBP patients.  Materials and Methods:  The participants were twenty-nine women who were randomly divided into a control group (CON) and a 3D exercise group (3DEG), which took part in 3D moving exercise three times a week for 8 weeks. Both groups measured a visual analog scale (VAS) about their CLBP. Body composition, forward and backward trunk flexibilities, static muscle contraction property in rectus abdominis, and erector spinae were measured by tensiomyography, which found contraction time (Tc) and maximal displacement (Dm). Dynamic muscle contraction property in the abdomen and back were measured with an isokinetic device, which could measure peak torque (Pt) and work per repetition (Wr), before and after the trial.  Results:  The 3DEG had a significantly decreased fat mass and waist/hip ratio, as well as improved static muscle contractions of the erector spinae. The Wr of trunk extensor of 3D exercise group were also significantly increased. In the VAS, although the scores showed a significant change in some variables, while others did not. The Δ% in feeling pain at rest or at night, during exercise, walking, sitting in a hard chair, sitting in a soft chair, and lying down in 3DEG were significantly changed after 8 weeks. This indicates that the platform exercise provided a greater reduction of pain for activities that are done on a daily basis.  Conclusions : This study confirms that the 3D moving platform exercise can provide the similar effect of the core stability exercise used in previous studies. Moreover, this study suggests that 3D moving platform exercise is a suitable means to reduce fatness, to increase trunk extensor, and to increase trunk backward flexibility, which led to reduced back pain in the women with CLBP.",2020,"The 3DEG had a significantly decreased fat mass and waist/hip ratio, as well as improved static muscle contractions of the erector spinae.","['CLBP patients', 'women with CLBP', 'participants were twenty-nine women', 'Patients with Chronic Low Back Pain', 'Patient-handling activities predispose women to chronic low back pain (CLBP']","['3D Moving Platform Exercise', 'control group (CON) and a 3D exercise group (3DEG']","['pain for activities', 'fat mass and waist/hip ratio', 'visual analog scale (VAS', 'trunk backward flexibility', 'back pain', 'peak torque (Pt) and work per repetition (Wr', 'contraction time (Tc) and maximal displacement (Dm', 'static muscle contractions', 'Physiological Parameters and Pain', 'Body composition, forward and backward trunk flexibilities, static muscle contraction property in rectus abdominis, and erector spinae']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C2350569', 'cui_str': 'Patient Handling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}]",29.0,0.0385122,"The 3DEG had a significantly decreased fat mass and waist/hip ratio, as well as improved static muscle contractions of the erector spinae.","[{'ForeName': 'Soochul', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Education Major of Physical Education, Graduate School of Education of Hanseo University, Hanseo 1-Ro, Haemi-myeon, Seosan 31962, Korea.'}, {'ForeName': 'Yongseok', 'Initials': 'Y', 'LastName': 'Jee', 'Affiliation': 'Department of Education Major of Physical Education, Graduate School of Education of Hanseo University, Hanseo 1-Ro, Haemi-myeon, Seosan 31962, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070351']
3134,32679757,Characterizing the Heart Rate Response to the 4 × 4 Interval Exercise Protocol.,"High intensity interval training is frequently implemented using the 4 × 4 protocol where four 4-min bouts are performed at heart rate (HR) between 85 and 95% HR max. This study identified the HR and power output response to the 4 × 4 protocol in 39 active men and women (age and VO 2  max = 26.0 ± 6.1 years and 37.0 ± 5.4 mL/kg/min). Initially, participants completed incremental cycling to assess VO 2  max, HR max, and peak power output (PPO). They subsequently completed the 4 × 4 protocol, during which HR and power output were monitored. Data showed that 12.9 ± 0.4 min of 16 min were spent between 85 and 95% HR max, with time spent significantly lower in interval 1 (2.7 ± 0.6 min) versus intervals 2-4 (3.4 ± 0.4 min, 3.4 ± 0.3 min, and 3.5 ± 0.3 min,  d  = 2.4-2.7). Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0). To enhance time spent between 85 and 95% HR max for persons with higher fitness, we recommend immediate allocation of supramaximal intensities in interval one.",2020,"Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0).",['39 active men and women (age and VO 2  max = 26.0 ± 6.1 years and 37.0 ± 5.4 mL/kg/min'],['High intensity interval training'],"['VO 2  max, HR max, and peak power output (PPO', 'Power output', 'Heart Rate Response']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0032956', 'cui_str': 'Preferred Provider Organization'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}]",,0.0733088,"Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0).","[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Acala', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}, {'ForeName': 'Devyn', 'Initials': 'D', 'LastName': 'Roche-Willis', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17145103']
3135,32679839,Effect of Viewing Video Representation of the Urban Environment and Forest Environment on Mood and Level of Procrastination.,"A common problem among students is the problem of delaying important work activities, which is conceptualized as procrastination. Since procrastination can cause considerable costs for society, we would like to find a method to effectively alleviate the symptoms of this conditioning. It has been proven in an earlier study that staying in the forest environment increases vitality and reduces anxiety, and the negative state of these features can be associated with the intensification of procrastination symptoms. Therefore, it is likely that watching a forest video may decrease the probability or intensity of procrastination. To measure the impact of the forest environment on the level of procrastination of the subjects, a randomized experiment was carried out, in which the subjects watched in random order (on different days) one of two 15-min videos: one showing a walk in the forest area and one showing a walk in an urban environment (control). We measured the level of so-called 'fluid procrastination' including three aspects: 'lack of energy to do the work', 'inability to get to work' and 'pessimistic attitude to do the work' with a set of questions the respondents completed before and after the experiment. The results showed that one aspect of fluid procrastination ('pessimistic attitude to do the work') can be effectively lowered by watching a video showing the forest environment. In contrast, watching a video of an urban environment increased the procrastination levels for two other aspects of procrastination ('lack of energy to do the work', 'inability to get to work'). We also measured three other parameters before and after the experiment: mood state, restoration and vitality. Watching the video from forest area raised mood and restoration and watching the video from urban area, decreased mood, vitality and restoration. The study suggests that watching a video showing forest landscapes could be used as an effective remedy for problems related to procrastination among students.",2020,"Watching the video from forest area raised mood and restoration and watching the video from urban area, decreased mood, vitality and restoration.",[],"['Viewing Video Representation of the Urban Environment and Forest Environment', '15-min videos: one showing a walk in the forest area and one showing a walk in an urban environment (control']","['Mood and Level of Procrastination', 'mood state, restoration and vitality']",[],"[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",,0.0230505,"Watching the video from forest area raised mood and restoration and watching the video from urban area, decreased mood, vitality and restoration.","[{'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Bielinis', 'Affiliation': 'Department of Forestry and Forest Ecology, Faculty of Environmental Management and Agriculture, University of Warmia and Mazury, Pl. Łódzki 2, 10-727 Olsztyn, Poland.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Simkin', 'Affiliation': 'Natural Resources Institute Finland, Latokartanonkaari 9, 00790 Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Puttonen', 'Affiliation': 'Department of Forest Sciences, University of Helsinki, Latokartanonkaari 7, 00014 Helsinki, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Tyrväinen', 'Affiliation': 'Natural Resources Institute Finland, Latokartanonkaari 9, 00790 Helsinki, Finland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145109']
3136,32680615,Effect of body position on cardiorespiratory stabilization and comfort in preterm infants on continuous positive airway pressure.,"PURPOSE


The purpose of the study is to investigate the effect of four body positions (supine, prone, left lateral, right lateral) on cardiorespiratory stabilization and comfort in preterm infants receiving Nasal Continuous Positive Airway Pressure (NCPAP).
DESIGN AND METHODS


In the study conducted as a randomized crossover design, the sample was composed of 20 preterm infants receiving NCPAP therapy. At each change of position, the baby was allowed to stabilize for 15 min, and heart rate and oxygen saturation values were recorded every 10 min for the next 60 min. The comfort levels of the infants in each position were evaluated at 30th and 60th minutes using the Premature Infant Comfort Scale.
RESULTS


At the end of the study, it was determined that there was no statistically significant difference between heart rate (p = .83), respiratory rate (p = .90) and oxygen saturation (p = .15) of the infants in terms of their positions. When the mean comfort scores of the preterm infants were compared in terms of position, it was found that there was a difference between the positions (p < .01). According to the scale evaluation, the highest comfort level of the infants was in the prone position, which was followed by right lateral, supine and left lateral positions.
PRACTICE IMPLICATIONS


Prone position was the most comfortable for preterm infants. However, comfort levels of preterm infants were also high enough in other positions so that no intervention is needed. In order to ensure comfort and cardiorespiratory stabilization, any of the four body positions can be chosen.",2020,"At the end of the study, it was determined that there was no statistically significant difference between heart rate (p = .83), respiratory rate (p = .90) and oxygen saturation (p = .15) of the infants in terms of their positions.","['20 preterm infants receiving NCPAP therapy', 'preterm infants receiving Nasal Continuous Positive Airway Pressure (NCPAP', 'preterm infants on continuous positive airway pressure', 'preterm infants']","['four body positions (supine, prone, left lateral, right lateral', 'body position']","['oxygen saturation', 'cardiorespiratory stabilization and comfort', 'heart rate', 'mean comfort scores', 'heart rate and oxygen saturation values', 'respiratory rate']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0450414', 'cui_str': 'Lateral to the left'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",20.0,0.029714,"At the end of the study, it was determined that there was no statistically significant difference between heart rate (p = .83), respiratory rate (p = .90) and oxygen saturation (p = .15) of the infants in terms of their positions.","[{'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Çakıcı', 'Affiliation': ""Istanbul Zeynep Kamil Women's and Children's Diseases Training and Research Hospital, Neonatal Intensive Care Unit, Istanbul, Turkey.""}, {'ForeName': 'Birsen', 'Initials': 'B', 'LastName': 'Mutlu', 'Affiliation': 'Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing, Pediatric Nursing Department, Istanbul, Turkey. Electronic address: bdonmez@istanbul.edu.tr.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.06.015']
3137,32680630,"Corrigendum to 'Unmet Needs of US Acute Stroke Survivors Enrolled in a Transitional Care Intervention Trial' [Journal of Stroke and Cerebrovascular Diseases, Vol. 29, No. 2 (February), 2020: 104462].",,2020,,[],[],[],[],[],[],,0.0411084,,"[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Hughes', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI. Electronic address: hughesa@msu.edu.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Woodward', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI.'}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Fritz', 'Affiliation': 'Michigan State University, Department of Epidemiology and Biostatistics, East Lansing, MI.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Swierenga', 'Affiliation': 'Michigan State University, Outreach and Engagement, East Lansing, MI.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Freddolino', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Reeves', 'Affiliation': 'Michigan State University, Department of Epidemiology and Biostatistics, East Lansing, MI.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105044']
3138,32680742,Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial.,"QUESTION


Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery?
DESIGN


Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.
PARTICIPANTS


Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand.
INTERVENTIONS


The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only.
OUTCOME MEASURES


The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months.
RESULTS


Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention.
CONCLUSIONS


Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation.
TRIAL REGISTRATION


ACTRN12613000664741.",2020,"QUESTION


Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery?
","['Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand', 'pulmonary complications after major abdominal surgery']","['Preoperative physiotherapy', 'information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist', 'information booklet only']","['cost-effectiveness and QALY gains', 'Cost-utility for QALY gains', 'probability of cost-effectiveness and incremental net benefits']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1998150', 'cui_str': 'Respiratory education'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",441.0,0.169058,"QUESTION


Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery?
","[{'ForeName': 'Ianthe', 'Initials': 'I', 'LastName': 'Boden', 'Affiliation': 'Department of Physiotherapy, Launceston General Hospital, Launceston, Australia; Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia. Electronic address: ianthe.boden@ths.tas.gov.au.'}, {'ForeName': 'Iain K', 'Initials': 'IK', 'LastName': 'Robertson', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Neil', 'Affiliation': 'Health Economics Research Group, Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Reeve', 'Affiliation': 'School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand; Physiotherapy Department, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Palmer', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia; Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Skinner', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Melbourne, Australia; Allied Health Research Unit, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Browning', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Melbourne, Australia; Directorate of Community Integration, Allied Health and Service Planning, Western Health, Melbourne, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Physiotherapy Department, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Cat', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Physiotherapy Department, North West Regional Hospital, Burnie, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Centre for Integrated Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'Head Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia; Allied Health Research lead, Peter McCallum Cancer Centre, Melbourne, Australia.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.06.005']
3139,32680754,"Efficacy of Adductor Canal Block Combined With Additional Analgesic Methods for Postoperative Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study.","BACKGROUND


The aim of this study is to evaluate the efficacy of adductor canal block (ACB) combined with additional analgesic methods in total knee arthroplasty (TKA) and investigate whether blocking the sensory nerves that are distributed in the posterior and lateral aspect of knee could improve postoperative pain control.
METHODS


Two hundred scheduled patients for TKA were randomly allocated into 4 groups: Group A received ACB combined with iPACK (interspace between the popliteal artery and capsule of the knee) block and lateral femoral cutaneous nerve block (LFCNB); Group B received ACB combined with iPACK block; Group C received ACB combined with LFCNB; and Group D received ACB only. Postoperative pain score was the main primary outcome. Secondary outcomes included the morphine consumption and analgesic duration. Other outcomes included knee range of motion, quadriceps strength, ambulation, Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index physical function, timed up and go (TUG) test, and complications.
RESULTS


Groups A, B, and C had lower postoperative pain scores within 12 hours at rest and 8 hours with activity than Group D (P < .05). In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01). Group A had the longest analgesic duration (19.21 ± 3.22 hours) among all groups. There were no significant differences among the groups in terms of mobility and complication after surgery.
CONCLUSION


Combining ACB with both iPACK and LFCNB is an effective method for decreasing early postoperative pain in TKA without increasing the complications or affecting the early rehabilitation.",2020,"In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01).","['total knee arthroplasty (TKA', 'Total Knee Arthroplasty', 'Two hundred scheduled patients for TKA']","['ACB combined with iPACK (interspace between the popliteal artery and capsule of the knee) block and lateral femoral cutaneous nerve block (LFCNB); Group B received ACB combined with iPACK block', 'Adductor Canal Block Combined With Additional Analgesic Methods', 'adductor canal block (ACB) combined with additional analgesic methods', 'ACB combined with LFCNB', 'iPACK and LFCNB']","['mobility and complication', 'knee range of motion, quadriceps strength, ambulation, Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index physical function, timed up and go (TUG) test, and complications', 'longest analgesic duration', 'postoperative pain scores', 'morphine consumption', 'early postoperative pain', 'morphine consumption and analgesic duration', 'Postoperative pain score']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0394740', 'cui_str': 'Local anesthetic lateral femoral cutaneous nerve block'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",200.0,0.219531,"In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01).","[{'ForeName': 'Donghai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alqwbani', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Liao', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.06.060']
3140,32680757,Effectiveness of a home-based therapeutic exercise program on lower back pain and functionality in Sickle Cell Disease (SCD) patients.,"OBJECTIVE


To investigate the effectiveness of a home-based therapeutic exercise program on lower back pain and functionality of SCD patients.
SETTING


A Hematology and Transfusion Medicine Center, University of Campinas (HEMOCENTRO-UNICAMP).
METHODS


This was a prospective study, with a three-month follow-up of SCD patients with lower back pain. The lumbar spine functionality was evaluated by questionnaires, trunk flexion and extension analyses by fiber-optic-electrogoniometry and measurements of muscle strength of trunk flexor and extensors. The Intervention Group (IG) comprised 18 volunteers, median age 44y (28-58) and the control group (CG) comprised 15 volunteers, median age 42y (19-58), who did not perform exercises. The protocol consisted of daily home-based exercises with two evaluations: at the beginning and end of a three-month program. In order to compare the groups at baseline, the Fisher´s exact test and Mann-Whitney test were used for categorical and numeric variables, respectively. The Wilcoxon test was used for related samples comparing numeric measures of each group over time with a 5% (p < 0.05) significance level.
RESULTS


After the intervention, patients demonstrated a significant improvement, according to the Visual-Analog-Scale (VAS; p = 0.01), Rolland Morris Disability questionnaire (RMDQ; p < 0.01) and trunk flexion and extension muscle strength (p < 0.01). No significant differences were found for the Start-Back-Screening-Tool-Brazil (SBST) and in measures of trunk flexion and extension range-of-motion (RoM).
CONCLUSION


Results suggest that daily home-based exercises for a three-month period ameliorate pain and improve disability related to lower back pain and muscle strength.",2020,"No significant differences were found for the Start-Back-Screening-Tool-Brazil (SBST) and in measures of trunk flexion and extension range-of-motion (RoM).
","['Sickle Cell Disease (SCD) patients', 'SCD patients with lower back pain', 'SCD patients', '18 volunteers, median age 44y', '15 volunteers, median age 42y (19-58), who did not perform exercises']",['home-based therapeutic exercise program'],"['trunk flexion and extension muscle strength', 'lumbar spine functionality', 'Rolland Morris Disability questionnaire (RMDQ', 'Start-Back-Screening-Tool-Brazil (SBST) and in measures of trunk flexion and extension range-of-motion (RoM', 'Visual-Analog-Scale']","[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0223355,"No significant differences were found for the Start-Back-Screening-Tool-Brazil (SBST) and in measures of trunk flexion and extension range-of-motion (RoM).
","[{'ForeName': 'Camila Tatiana', 'Initials': 'CT', 'LastName': 'Zanoni', 'Affiliation': 'Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Galvão', 'Affiliation': 'Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Renata Manzano', 'Initials': 'RM', 'LastName': 'Maria', 'Affiliation': 'Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Zulli', 'Affiliation': 'Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Janaina Bosso', 'Initials': 'JB', 'LastName': 'Ricciardi', 'Affiliation': 'Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cliquet', 'Affiliation': 'Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Sara Teresinha Olalla', 'Initials': 'STO', 'LastName': 'Saad', 'Affiliation': 'Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil. Electronic address: sara@unicamp.br.'}]","Hematology, transfusion and cell therapy",['10.1016/j.htct.2020.05.004']
3141,32681228,Randomized Trial of Ciprofloxacin Doxycycline and Hydroxychloroquine Versus Budesonide in Active Crohn's Disease.,"BACKGROUND


Increased mucosa-associated E. coli are present in Crohn's disease, but their role in pathogenesis is uncertain.
AIMS


To assess efficacy and safety of an antibiotic/hydroxychloroquine combination effective against E. coli inside macrophages.
METHODS


Adults with moderately active disease (CDAI > 220-450 plus C reactive protein ≥ 5 mg/l and/or fecal calprotectin > 250 μg/g) were randomized to receive (open-label) oral budesonide (Entocort CR 9 mg/day 8 weeks, 6 mg/day 2 weeks, 3 mg/day 2 weeks) or oral ciprofloxacin 500 mg bd, doxycycline 100 mg bd, hydroxychloroquine 200 mg tds for 4 weeks, followed by doxycycline 100 mg bd and hydroxychloroquine 200 mg tds for 20 weeks. Primary endpoints were remission (CDAI ≤ 150) at 10 weeks, remission maintained to 24 weeks, and remission maintained to 52 weeks. Patients not responding (CDAI fall by > 70) by 10 weeks were invited to crossover onto the alternative therapy.
RESULTS


Fifty-nine patients were recruited across 8 sites. Including crossover, 39 patients received antibiotics/hydroxychloroquine and 39 received budesonide. At 10 weeks, 24 weeks, and 52 weeks on initial therapy, only 2/27, 2/27, and 1/27 were in remission on antibiotics/hydroxychloroquine compared with 8/32, 1/32, and 1/32 on budesonide (P = 0.092 at 10 weeks). Withdrawals by 10 weeks due to adverse events were seen in 15 receiving antibiotics/hydroxychloroquine and 6 budesonide. Results including crossover were more promising with 9/24 patients receiving antibiotics/hydroxychloroquine per protocol in remission by 24 weeks. No correlation was seen between response to antibiotics/hydroxychloroquine and ASCA/OmpC antibody status or disease location.
CONCLUSION


Overall results with this antibiotic/hydroxychloroquine combination were unimpressive, but long-term remission is seen in some patients and justifies further study.",2020,No correlation was seen between response to antibiotics/hydroxychloroquine and ASCA/,"['Fifty-nine patients were recruited across 8 sites', '250\xa0μg', ""Active Crohn's Disease"", 'Patients not responding (CDAI fall by\u2009>\u200970) by 10\xa0weeks', 'Adults with moderately active disease (CDAI\u2009>\u2009220-450 plus C reactive protein\u2009≥']","['hydroxychloroquine', 'Ciprofloxacin Doxycycline and Hydroxychloroquine Versus Budesonide', 'doxycycline 100\xa0mg bd and hydroxychloroquine', 'oral ciprofloxacin 500\xa0mg bd, doxycycline 100\xa0mg bd, hydroxychloroquine', 'antibiotic/hydroxychloroquine', 'budesonide', 'budesonide ', 'antibiotics/hydroxychloroquine']","['efficacy and safety', 'adverse events', 'remission (CDAI\u2009≤\u2009150) at 10\xa0weeks, remission maintained to 24\xa0weeks, and remission']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1123173', 'cui_str': 'Ciprofloxacin 500 MG'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",59.0,0.0864751,No correlation was seen between response to antibiotics/hydroxychloroquine and ASCA/,"[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Rhodes', 'Affiliation': 'Henry Wellcome Laboratory, Department of Molecular and Clinical Cancer Medicine, Institute of Systems, Molecular and Integrative Biology, Royal Liverpool University Hospital, University of Liverpool, Nuffield Building, Crown Street, Liverpool, L69 3GE, UK. rhodesjm@liverpool.ac.uk.'}, {'ForeName': 'Sreedhar', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': 'Henry Wellcome Laboratory, Department of Molecular and Clinical Cancer Medicine, Institute of Systems, Molecular and Integrative Biology, Royal Liverpool University Hospital, University of Liverpool, Nuffield Building, Crown Street, Liverpool, L69 3GE, UK.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Flanagan', 'Affiliation': 'Wirral University Teaching Hospital, Birkenhead, UK.'}, {'ForeName': 'Graham W', 'Initials': 'GW', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Aberdeen, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Henry Wellcome Laboratory, Department of Molecular and Clinical Cancer Medicine, Institute of Systems, Molecular and Integrative Biology, Royal Liverpool University Hospital, University of Liverpool, Nuffield Building, Crown Street, Liverpool, L69 3GE, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mansfield', 'Affiliation': 'Newcastle upon Tyne Hospitals, Newcastle upon Tyne, UK.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Parkes', 'Affiliation': 'Cambridge University Hospitals, Cambridge, UK.'}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Hart', 'Affiliation': ""St Mark's Hospital, Harrow, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dallal', 'Affiliation': 'James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Iqbal', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Butterworth', 'Affiliation': 'Shrewsbury and Telford Hospital, Shrewsbury, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Culshaw', 'Affiliation': 'Liverpool Cancer Trials Unit, Liverpool, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Probert', 'Affiliation': 'Henry Wellcome Laboratory, Department of Molecular and Clinical Cancer Medicine, Institute of Systems, Molecular and Integrative Biology, Royal Liverpool University Hospital, University of Liverpool, Nuffield Building, Crown Street, Liverpool, L69 3GE, UK.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06477-y']
3142,32681234,Facial taping as biofeedback to improve the outcomes of physical rehab in Bell's palsy: preliminary results of a randomized case-control study.,"PURPOSE


This study aimed to investigate the efficacy of taping in association with Kabat rehabilitation to ameliorate the outcomes of Bell's palsy.
METHODS


This case-control study was conducted on hospital-outbound patients. 20 patients over 18 years affected from Bell's palsy were recruited at the onset of the disease (< 5 days). Patients were simply randomized into two groups. Patients in group A underwent exclusively Kabat rehabilitation, while patients in group B were treated by combining facial taping and Kabat. Facial palsy severity was evaluated with ADS assessment at baseline (T0), 1 week (T1), 1 month (T2) and 3 months (T3) after treatment. One-way ANOVA was used to compare ADS scores variance between groups to evaluate differences between the two treatments.
RESULTS


Both groups presented statistically significant differences comparing the baseline with the other observational points (within analysis) (p < 0.0001). Patients in group B showed a statistically significant improvement compared to group A (between analyses) (p < 0.0001), especially at T2 (p < 0.01).
CONCLUSIONS


Facial taping combined with Kabat rehabilitation allowed to reduce the time of recovery and improved the outcomes of Bell's palsy.",2020,"Patients in group B showed a statistically significant improvement compared to group A (between analyses) (p < 0.0001), especially at T2 (","[""Bell's palsy"", ""20 patients over 18\xa0years affected from Bell's palsy were recruited at the onset of the disease (<\u20095\xa0days"", 'hospital-outbound patients']","['Facial taping combined with Kabat rehabilitation', 'Facial taping', 'combining facial taping and Kabat', 'Kabat rehabilitation']","['ADS scores variance', 'Facial palsy severity', 'time of recovery']","[{'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",20.0,0.0999963,"Patients in group B showed a statistically significant improvement compared to group A (between analyses) (p < 0.0001), especially at T2 (","[{'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': 'Otolaryngology Department, University of Perugia, Piazza Menghini 1, 06129, Perugia, Italy. ariannadistadio@hotmail.com.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gambacorta', 'Affiliation': 'Otolaryngology Department, University of Perugia, Piazza Menghini 1, 06129, Perugia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Pagliari', 'Affiliation': 'Otolaryngology Department, Silvestrini Hospital, Perugia, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Longari', 'Affiliation': 'Otolaryngology Department, University of Perugia, Piazza Menghini 1, 06129, Perugia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Ricci', 'Affiliation': 'Otolaryngology Department, University of Perugia, Piazza Menghini 1, 06129, Perugia, Italy.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06193-3']
3143,32681303,Hispanic ethnicity as a moderator of the effects of aerobic and resistance exercise on physical fitness and quality-of-life in breast cancer survivors.,"BACKGROUND


Exercise can profoundly affect physical fitness and quality of life in breast cancer survivors; however, few studies have focused on minorities. This secondary analysis examines Hispanic ethnicity as a moderator of the effects of a 16-week aerobic and resistance exercise intervention on physical fitness and quality of life in breast cancer survivors.
METHODS


Eligible breast cancer survivors (n = 100) were randomized to exercise (n = 50) or usual care (n = 50). The exercise intervention consisted of supervised moderate-vigorous aerobic and resistance exercise thrice weekly for 16 weeks. Physical fitness and quality of life were measured at baseline, post-intervention, and 28-week follow-up (exercise only). Linear mixed-models adjusted for baseline value of the outcome, age, disease stage, adjuvant treatment, and recent physical activity were used to evaluate effect modification by ethnicity.
RESULTS


The study sample included 57% Hispanic and 43% non-Hispanic breast cancer survivors. Hispanic breast cancer survivors were younger, less fit, and diagnosed with more advanced cancers compared with non-Hispanic breast cancer survivors (p < 0.001). Ethnicity was found to moderate the effects of exercise training on all physical fitness and quality-of-life measures including VO 2max  (8.4 mL/kg/min; 95% confidence interval (95% CI) 3.2 to 13.4), physical well-being (12.3; 95% CI 4.2 to 18.4), and emotional well-being (11.4; 95% CI 5.9 to 15.5). In all cases, Hispanics experienced larger benefits than non-Hispanics.
CONCLUSIONS


Hispanic breast cancer survivors have poorer cardiorespiratory fitness, muscle strength, and quality-of-life and therefore may derive larger benefits from exercise than non-Hispanic breast cancer survivors. Clinical exercise interventions may attenuate existing health disparities among minority breast cancer survivors.
IMPLICATION OF CANCER SURVIVORS


Here we report psychosocial and fitness-related disparities among Hispanic breast cancer survivors when compared with their non-Hispanic counterparts. Our exercise intervention highlights the importance of exercise for minority cancer survivors and the need for distinct, culturally tailored exercise intervention approaches to reduce psychosocial and fitness-related disparities among this understudied population of cancer survivors.",2020,"Ethnicity was found to moderate the effects of exercise training on all physical fitness and quality-of-life measures including VO 2max  (8.4 mL/kg/min; 95% confidence interval (95% CI) 3.2 to 13.4), physical well-being (12.3; 95% CI 4.2 to 18.4), and emotional well-being (11.4; 95% CI 5.9 to 15.5).","['OF CANCER SURVIVORS', 'minority cancer survivors', 'Hispanic breast cancer survivors', 'breast cancer survivors', 'Eligible breast cancer survivors (n\u2009=\u2009100', 'The study sample included 57% Hispanic and 43% non-Hispanic breast cancer survivors', 'minority breast cancer survivors']","['exercise training', 'aerobic and resistance exercise intervention', 'exercise intervention', 'Clinical exercise interventions', 'aerobic and resistance exercise', 'exercise (n\u2009=\u200950) or usual care', 'exercise intervention consisted of supervised moderate-vigorous aerobic and resistance exercise']","['physical fitness and quality-of-life measures including VO 2max', 'cardiorespiratory fitness, muscle strength, and quality-of-life', 'physical fitness and quality of life', 'physical fitness and quality-of-life', 'Physical fitness and quality of life']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",100.0,0.0437343,"Ethnicity was found to moderate the effects of exercise training on all physical fitness and quality-of-life measures including VO 2max  (8.4 mL/kg/min; 95% confidence interval (95% CI) 3.2 to 13.4), physical well-being (12.3; 95% CI 4.2 to 18.4), and emotional well-being (11.4; 95% CI 5.9 to 15.5).","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, 375 Longwood Ave., Boston, MA, 02215, USA. ChristinaM_Dieli-Conwright@DFCI.Harvard.edu.'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Fox', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, Ostrow School of Dentistry, University of Southern California (USC), Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sami', 'Affiliation': 'Department of Medicine, Keck School of Medicine, USC, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Van Fleet', 'Affiliation': 'Department of Medicine, Keck School of Medicine, USC, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, USC, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Spicer', 'Affiliation': 'Department of Medicine, Keck School of Medicine, USC, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Kyuwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Population Sciences, Beckman Research Institute, City of Hope (COH), Duarte, CA, 91010, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mortimer', 'Affiliation': 'Division of Medical Oncology and Experimental Therapeutics, COH, Duarte, CA, 91010, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Bernstein', 'Affiliation': 'Division of Biomarkers of Early Detection and Prevention, Beckman Research Institute, COH, Duarte, CA, 91010, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, Alberta, T6G 2H9, Canada.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00918-3']
3144,32681304,"Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study.","PURPOSE


To examine the feasibility of an enhanced survivorship care plan (ESCP) that integrated the web-based program Patient Education Resources for Couples (PERC) into a standardized survivorship care plan (SCP) and estimated the outcomes of ESCPs versus SCPs.
METHODS


In this randomized pilot trial, localized prostate cancer (PC) patients and partners (i.e., couple) were randomly assigned to ESCP that contained a link to PERC or to SCP that contained a link to general PC information on the National Cancer Institute website. Couples completed assessments measuring quality of life (QOL), appraisal of symptoms, and coping resources at baseline (T1) and 4-6 months later (T2). We examined feasibility (e.g., recruitment and retention) using descriptive statistics. Linear mixed models examined changes in couples' outcomes over time and Poisson regression examined differences in patient healthcare utilization.
RESULTS


Sixty-two couples completed T1 surveys (recruitment rate 41.6%) and were randomly assigned to receive ESCP (n = 31) or SCP (n = 31). Twenty-eight (ESCP) and 25 (SCP) couples completed T2 surveys (retention rates = 90.3% vs. 80.7%). ESCP participants (70%) reviewed webpages consistent with patients' symptoms. ESCP patients reported greater program satisfaction (p = 0.02) and better urinary symptom scores (p < 0.01) than SCP patients.
CONCLUSIONS


Delivering ESCPs that embed a web-link to a couple-focused, tailored program is feasible and can potentially improve patient outcomes. The promising results need to be validated in a larger definitive trial using a diverse sample.
IMPLICATIONS FOR CANCER SURVIVORS


SCPs, enhanced using a web-based intervention (e.g., PERC), may help PC cancer survivors better manage their urinary symptoms.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT04350788.",2020,"ESCP patients reported greater program satisfaction (p = 0.02) and better urinary symptom scores (p < 0.01) than SCP patients.
","['localized prostate cancer (PC) patients and partners (i.e., couple', 'Sixty-two couples completed T1 surveys (recruitment rate 41.6', 'patients with localized prostate cancer']","['ESCP', 'enhanced survivorship care plan (ESCP', 'SCP']","['urinary symptom scores', 'quality of life (QOL), appraisal of symptoms, and coping resources', 'program satisfaction']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",62.0,0.0793972,"ESCP patients reported greater program satisfaction (p = 0.02) and better urinary symptom scores (p < 0.01) than SCP patients.
","[{'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'School of Nursing, University of North Carolina (UNC), Carrington Hall, Chapel Hill, NC, 27599-7460, USA. lsong@unc.edu.'}, {'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'School of Nursing, University of North Carolina (UNC), Carrington Hall, Chapel Hill, NC, 27599-7460, USA.'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, NC, USA.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Chen', 'Affiliation': 'University of Kansas Medical Center, Kansas City, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Nielsen', 'Affiliation': 'Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, NC, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Birken', 'Affiliation': 'Gillings School of Global Public Health, UNC, Chapel Hill, NC, USA.'}, {'ForeName': 'Bridget F', 'Initials': 'BF', 'LastName': 'Koontz', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Laurel L', 'Initials': 'LL', 'LastName': 'Northouse', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Mayer', 'Affiliation': 'School of Nursing, University of North Carolina (UNC), Carrington Hall, Chapel Hill, NC, 27599-7460, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00914-7']
3145,32681460,Reduced Hypoglycemia Risk in Type 2 Diabetes Patients Switched to/Initiating Insulin Glargine 300 vs 100 U/ml: A European Real-World Study.,"INTRODUCTION


Randomized controlled trials and real-world data from the USA have shown similar glycemic control with insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) and reduced hypoglycemia risk with Gla-300. This real-world study describes the efficacy and safety of Gla-300 and Gla-100 in patients with type 2 diabetes (T2D) in France, Spain, and Germany.
METHODS


This retrospective chart review analysis used anonymized data for adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100. Outcomes included change from baseline to 6-month follow-up in glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice.
RESULTS


Six hundred sixty-five physicians (33.8% Spain, 31.7% France, 34.4% Germany) provided chart data for patients switching to Gla-300 (n = 679) or Gla-100 (n = 429) or initiating Gla-300 (n = 719) or Gla-100 (n = 711). After adjustment for baseline characteristics, A1C reductions from baseline were similar for patients switching to Gla-300 or Gla-100 (- 0.87% vs. - 0.93%; p = 0.326) while those switched to Gla-300 vs. Gla-100 had a significantly greater mean reduction in hypoglycemic events (- 1.29 vs. - 0.81 events during 6 months; p = 0.012). Mean insulin doses after titration were 0.43 ± 0.36 and 0.40 ± 0.28 U/kg in Gla-300 and Gla-100 switchers, respectively. Factors that significantly influenced BIA choice included a lower risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100). Outcomes for insulin-naïve patients were broadly similar to those of switchers.
CONCLUSIONS


In this real-world European study, patients with T2D who switched therapy to Gla-300 or Gla-100 had improved glycemic control and reduced hypoglycemia at 6 months, with significant hypoglycemia advantages with Gla-300.",2020,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","['Six hundred sixty-five physicians', '300 vs 100 U', 'adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100', 'patients with type 2 diabetes (T2D) in France, Spain, and Germany']","['Gla-300 and Gla-100', 'Insulin Glargine']","['glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice', 'risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100', 'Hypoglycemia Risk', 'Mean insulin doses', 'glycemic control and reduced hypoglycemia', 'hypoglycemic events', 'hypoglycemia risk']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]",,0.0204853,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escalada', 'Affiliation': 'Clinic University of Navarra, Pamplona, Spain. fjavier.escalada@gmail.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': 'CHU de Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Jasmanda', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Janelle M', 'Initials': 'JM', 'LastName': 'Cambron-Mellott', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Nicholls', 'Affiliation': 'Sanofi, Reading, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine, University Hospital Aachen, Aachen, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01436-5']
3146,32681461,"The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652 in First-in-Human and Ascending Multiple Oral Dose Studies in Healthy Subjects.","INTRODUCTION


Inhibitors of fatty acid amide hydrolase (FAAH) increase the levels of endocannabinoids and have shown analgesic and anti-inflammatory activity in animal models. ASP3652 is a peripherally acting FAAH inhibitor in development for the treatment of chronic bladder and pelvic pain disorders. Here we describe the safety, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ASP3652 administered in healthy non-elderly and elderly male and female volunteers.
METHODS


Study 1 was a combined single-ascending dose and food-effect study in which ASP3652 was given as single doses (1-600 mg) or matching placebo in healthy subjects. Study 2 was a multiple ascending dose study in which ASP3652 or matching placebo was administered in multiple oral doses (10-300 mg bid and 600 mg qd for 14 days) to healthy subjects. In both studies, the levels of ASP3652, FAAH, endocannabinoids (eCBs) and safety were evaluated.
RESULTS


ASP3652 was readily absorbed to reach C max  at 1 h after a single dose. Steady state was reached within 3 days after the start of multiple dosing. The C max  and AUC of ASP3652 increased in a slightly more than dose-proportional manner after a single dose of ASP3652 at 30-600 mg. There was some accumulation (15-38%) based on C max  and AUC 12h  upon multiple doses. C max  was 47% lower in combination with food. There was no significant effect of gender or age on the pharmacokinetics of ASP3652. FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA). The incidence of adverse events following multiple doses was similar across all treatment groups including the placebo group.
CONCLUSIONS


Single and multiple doses of ASP3652 were safe and well tolerated and increased endogenous cannabinoid plasma levels.",2020,"FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA).","['healthy subjects', 'Healthy Subjects', 'healthy non-elderly and elderly male and female volunteers']","['placebo', 'ASP3652', 'matching placebo', 'ASP3652 or matching placebo']","['Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652', 'plasma levels of anandamide (AEA', 'safe and well tolerated and increased endogenous cannabinoid plasma levels', 'FAAH activity', 'Steady state', 'levels of ASP3652, FAAH, endocannabinoids (eCBs) and safety', 'adverse events', 'C max  and AUC of ASP3652']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0491394,"FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA).","[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. masaomi.takizawa@astellas.com.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Cerneus', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Michon', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Rijnders', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'van der Heide', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Meijer', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stoelzel', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc., Ibaraki, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01402-1']
3147,32681463,Effects of oral contraceptives on serum concentrations of adipokines and adiposity indices of women with polycystic ovary syndrome: a randomized controlled trial.,"PURPOSE


To compare the effects of oral contraceptives (OCs) with different progestins, including Levonorgestrel (LNG), Desogestrel (DSG), Cyproterone Acetate (CPA), and Drospirenone (DRSP) on adipokines levels and adiposity indices in women with polycystic ovary syndrome (PCOS).
METHODS


In this parallel randomized clinical trial, 120 women with PCOS randomly assigned to intervention with OCs containing LNG, DSG, CPA, or DRSP. Outcomes of interest, including serum concentrations of adiponectin, leptin, and resistin, and adiposity indices, i.e., body mass index (BMI), waist circumference (WC), obesity, central obesity, waist to hip ratio (WHR), waist to height ratio (WHtR), lipid accumulation product (LAP), a body shape index (ABSI), body roundness index (BRI), and visceral adiposity index (VAI), and lipid profiles were assessed at baseline, and 6 months of treatment.
RESULTS


This study showed no significant differences in serum concentrations of adipokines between the four study groups after 6 months of treatment. Our results also showed that patients treated with various compounds of OC for 6 months had no significant differences in their adiposity indices, except for LAP (p = 0.04), and VAI (p = 0.03). PCOS patients treated with OCs containing CPA had significantly a higher mean LAP, compared to those using products containing LNG. Besides, patients treated with OCs containing CPA had significantly a higher mean VAI, compared to those treated with OCs containing DRSP.
CONCLUSION


This study demonstrated that OCs with low androgenic and antiandrogenic activities had identical effects on serum concentrations of adipokines, and adiposity indices, except LAP, and VAI parameters.
REGISTRATION NUMBER


IRCT20080929001281N3.",2020,"PCOS patients treated with OCs containing CPA had significantly a higher mean LAP, compared to those using products containing LNG.","['120 women with PCOS randomly assigned to', 'women with polycystic ovary syndrome (PCOS', 'women with polycystic ovary syndrome']","['OCs containing CPA', 'oral contraceptives (OCs) with different progestins, including Levonorgestrel (LNG), Desogestrel (DSG), Cyproterone Acetate (CPA), and Drospirenone (DRSP', 'oral contraceptives', 'intervention with OCs containing LNG, DSG, CPA, or DRSP']","['higher mean VAI', 'adiposity indices', 'serum concentrations of adipokines and adiposity indices', 'adipokines levels and adiposity indices', 'serum concentrations of adipokines, and adiposity indices, except LAP, and VAI parameters', 'serum concentrations of adipokines', 'serum concentrations of adiponectin, leptin, and resistin, and adiposity indices, i.e., body mass index (BMI), waist circumference (WC), obesity, central obesity, waist to hip ratio (WHR), waist to height ratio (WHtR), lipid accumulation product (LAP), a body shape index (ABSI), body roundness index (BRI), and visceral adiposity index (VAI), and lipid profiles', 'higher mean LAP']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0056855', 'cui_str': 'Cyproterone acetate'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3658347', 'cui_str': 'Lipid Accumulation Product'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",120.0,0.132495,"PCOS patients treated with OCs containing CPA had significantly a higher mean LAP, compared to those using products containing LNG.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nahidi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ramezani Tehrani', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, Tehran, Iran. ramezani@endocrine.ac.ir.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01349-8']
3148,32681472,"Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data.","INTRODUCTION


An extensive clinical development program showed that the meningococcal serogroup B-factor H binding protein (MenB-FHbp) vaccine affords protection against MenB disease for adolescents and adults. Data were pooled from multiple studies within the program to examine whether MenB-FHbp immunogenicity was influenced by sex, age, or race.
METHODS


Immunogenicity was assessed in subjects from seven studies who received 120 µg MenB-FHbp (at 0, 2, 6 months) and had evaluated immune responses against four representative test strains via serum bactericidal assays using human complement (hSBAs). Immune responses were presented by sex (male, female), age group (10-14, 15-18, 19-25, 10-25 years), and race (white, black, Asian, other).
RESULTS


Among 8026 subjects aged 10-25 years included in this analysis, MenB-FHbp elicited robust immune responses in a high percentage of subjects regardless of demographic characteristics. Across all test strains and demographic subsets, a ≥ 4-fold rise in titer from baseline was achieved in 76.7-95.0% of subjects, with no major differences by sex, age groups assessed, or races evaluated. Corresponding percentages achieving titers ≥ the lower limit of quantification (LLOQ) against all four strains combined were 79.7-87.3% (sex), 81.6-85.5% (age), and 80.0-88.1% (race). Minor differences were observed for geometric mean titers and percentages of subjects achieving titers ≥ LLOQ against each strain based on demographics.
CONCLUSION


These data suggested no clinically meaningful differences in MenB-FHbp immunogenicity when administered as a three-dose schedule based on sex, ages assessed, or races evaluated. This analysis supports the continued recommended use of MenB-FHbp to prevent MenB disease in adolescents and young adults.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers, NCT00808028, NCT01830855, NCT01323270, NCT01461993, NCT01461980, NCT01352845, and NCT01299480.",2020,"Minor differences were observed for geometric mean titers and percentages of subjects achieving titers ≥ LLOQ against each strain based on demographics.
","['8026 subjects aged 10-25\xa0years', 'adolescents and young adults', 'adolescents and adults', 'Immune responses were presented by sex (male, female), age group (10-14, 15-18, 19-25, 10-25\xa0years), and race (white, black, Asian, other', 'subjects from seven studies who received 120\xa0µg MenB-FHbp (at 0, 2, 6\xa0months) and had evaluated immune responses against four representative test strains via serum bactericidal assays using human complement (hSBAs']",[],['geometric mean titers'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0033453', 'cui_str': 'Complement factor B'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009498', 'cui_str': 'Complement'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",8026.0,0.182601,"Minor differences were observed for geometric mean titers and percentages of subjects achieving titers ≥ LLOQ against each strain based on demographics.
","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beeslaar', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Hurley, UK. johannes.beeslaar@pfizer.com.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Peyrani', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Maguire', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eiden', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Balmer', 'Affiliation': 'Pfizer Vaccine Medical Development, Scientific and Clinical Affairs, Collegeville, PA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Maansson', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00322-5']
3149,32668114,Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury.,"BACKGROUND


Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain.
METHODS


We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days.
RESULTS


Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001).
CONCLUSIONS


Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).",2020,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","['critically ill patients with severe acute kidney injury', 'critically ill patients with acute kidney injury', 'Acute Kidney Injury', 'critically ill patients, many of whom receive renal-replacement therapy', '3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group']","['standard strategy (in which renal-replacement therapy', 'Renal-Replacement Therapy', 'accelerated strategy of renal-replacement therapy']","['Adverse events', 'death', 'death from any cause at 90 days', 'lower risk of death', 'renal-replacement therapy']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",3019.0,0.2899,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dreyfuss', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Gallagher', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Gaudry', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoste', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Schneider', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Orla M', 'Initials': 'OM', 'LastName': 'Smith', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Thomé', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Vaara', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Weir', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Amanda Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}]",The New England journal of medicine,['10.1056/NEJMoa2000741']
3150,32668323,A randomized controlled trial of lung ultrasound-guided therapy in heart failure (CLUSTER-HF study).,"BACKGROUND


Lung ultrasound (LUS) has emerged as a new tool for the evaluation of congestion in heart failure (HF); incorporation of LUS during follow-up may detect congestion earlier and prompt interventions to prevent hospitalizations. The aim of this study was to test the hypothesis that the incorporation of LUS during follow-up of patients with HF may reduce the rate of adverse events compared with usual care.
METHODS


In this single-blinded, randomized controlled trial, patients were randomized into an LUS-guided arm or control arm. Patients were followed in 4 prespecified visits during a 6-month period. LUS was performed in every patient visit in both groups; however, LUS results were available for the treating physician only in the LUS group. The primary outcome was the composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause.
RESULTS


One hundred twenty-six patients were randomized to either LUS (n = 63) or control (n = 63) (age 62.5 ± 10 years, median left ventricular ejection fraction 31%). The primary end point occurred in 30 (47.6%) patients in the control group and 20 (31.7%) patients in the LUS group (P = .041). LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001). No significant differences in rehospitalizations for HF or death were found.
CONCLUSIONS


Incorporation of LUS into clinical follow-up of patients with HF significantly reduced the risk of urgent visits for worsening HF.",2020,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).",['One hundred twenty-six patients'],"['LUS-guided arm or control arm', 'lung ultrasound-guided therapy', 'Lung ultrasound (LUS', 'LUS']","['rate of adverse events', 'urgent HF visits', 'rehospitalizations for HF or death', 'composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause', 'risk of urgent visits']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",126.0,0.114217,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Araiza-Garaygordobil', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico. Electronic address: dargaray@gmail.com.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gopar-Nieto', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Amezcua', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Cabello-López', 'Affiliation': 'Centro Médico Nacional ""Siglo XXI,"" Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Alanis-Estrada', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Luna-Herbert', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'González-Pacheco', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Cynthia Paola', 'Initials': 'CP', 'LastName': 'Paredes-Paucar', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Martinez Daniel', 'Initials': 'MD', 'LastName': 'Sierra-Lara', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Briseño-De la Cruz', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Rodriguez-Zanella', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Martinez-Rios', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Arias-Mendoza', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}]",American heart journal,['10.1016/j.ahj.2020.06.003']
3151,32680773,Long-term mucosal T cell activation and homing phenotypes in recipients of an Ad5-vectored HIV vaccine.,"BACKGROUND


Vaccine-induced mucosal immune responses may be critical for protection against HIV infection, but may also result in short or long-term changes that enhance susceptibility to infection in some individuals, such as those with baseline seroreactivity to vaccine vector antigens. We examined cellular immune responses in blood and gut mucosal tissue roughly two years following vaccination with placebo or the Step study vaccine MRKAd5/HIV-1.
METHODS


Participants vaccinated with either placebo or MRKAd5/HIV-1 during participation in HVTN 071, and HVTN 502/Merck 023 underwent phlebotomy and colonic mucosal biopsies via flexible sigmoidoscopy at two timepoints roughly six months apart. After isolation of mononuclear cells, we compared cellular phenotypes and intracellular cytokine responses in vaccine and placebo recipients with and without baseline serological reactivity to Ad5.
RESULTS


Surface expression of activation and gut-homing markers were elevated on CD4 + and CD8 + gut mucosal mononuclear cells (GMMC) in comparison with PBMC (p < 0.01), but were not significantly affected by baseline Ad5 serostatus or receipt of MRKAd5/HIV-1. ICS responses to stimulation with vaccine antigens were of low frequency and magnitude. Ad5 vector responses were seen in vaccinees and baseline seropositive individuals. CD4 + responses to vector antigens were more common in GMMC than PBMC (p < 0.01) and CD8 + responses to HIV gag insert antigens were more frequent in Ad5 seropositive than Ad5 seronegative individuals (p = 0.03).
CONCLUSION


Vaccination with the Ad5 vectored candidate HIV vaccine MRKAd5/HIV-1 does not lead to long-term changes in the activation state of mucosal CD4 + or CD8 + T lymphocytes regardless of baseline Ad5 serostatus. The findings of this study do not reveal a basis for enhanced susceptibility to HIV infection two years post vaccination.",2020,"CD4 + responses to vector antigens were more common in GMMC than PBMC (p < 0.01) and CD8 + responses to HIV gag insert antigens were more frequent in Ad5 seropositive than Ad5 seronegative individuals (p = 0.03).
","['Participants vaccinated with either', 'recipients of an Ad5-vectored HIV vaccine', 'during participation in HVTN 071, and HVTN 502/Merck 023 underwent']","['phlebotomy and colonic mucosal biopsies via flexible sigmoidoscopy', 'placebo or MRKAd5/HIV-1', 'placebo']","['CD4\xa0+\xa0and CD8\xa0+\xa0gut mucosal mononuclear cells (GMMC', 'cellular phenotypes and intracellular cytokine responses', 'Ad5 vector responses']","[{'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0852695', 'cui_str': 'Mucosal biopsy'}, {'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}]",,0.146174,"CD4 + responses to vector antigens were more common in GMMC than PBMC (p < 0.01) and CD8 + responses to HIV gag insert antigens were more frequent in Ad5 seropositive than Ad5 seronegative individuals (p = 0.03).
","[{'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Curlin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. Electronic address: curlin@ohsu.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Diaz', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Edlefsen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Novak', 'Affiliation': 'Division of Infectious Diseases, University of Illinois, Chicago, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'Fenway Health, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Maenza', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Buchbinder', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Keefer', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Stephen C De', 'Initials': 'SC', 'LastName': 'Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Duerr', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.06.043']
3152,32680781,Evaluating trajectories of statin adherence after a motivational interviewing intervention.,"OBJECTIVE


The objective of the current study was to compare postintervention adherence trajectories with preintervention trajectories for those receiving a telephonic motivational interviewing (MoI) intervention to determine predictors associated with each distinct postintervention trajectory and any association between pre- and postintervention trajectories.
DESIGN


Retrospective study design using group-based trajectory modeling.
SETTINGS AND PARTICIPANTS


A telephonic MoI intervention was conducted by trained student pharmacists to improve statin adherence in a Medicare Advantage plan. Four preintervention adherence trajectories were previously identified: rapid decline (RD), gradual decline (GD), gaps in adherence (GA), and adherent and were used to customize the MoI intervention. Patients from the 3 nonadherent preintervention trajectories were randomized to control or intervention groups and were followed for 6 months from the date of MoI intervention.
OUTCOME MEASURES


Group-based trajectory modeling was performed to identify 3 relevant postintervention trajectories. Descriptive statistics were used to assess differences in pre- and postintervention adherence trajectories. Multinomial logistic regression was conducted to determine predictors associated with each identified postintervention trajectory.
RESULTS


There were 152 intervention patients and 304 randomly selected controls. The prominent postintervention trajectories that were identified differed from the preintervention trajectories and were (1) GD (17.2%), (2) adherent (61.9%), and (3) discontinuation (20.9%). Among the intervention group, more patients in the GA preintervention trajectory (58.65%) moved to the adherent trajectory postintervention than those in the RD and GD preintervention trajectories. Furthermore, the predictors associated with the postintervention trajectories included MoI intervention, prescriber specialty, presence of diabetes, presence of congestive heart failure, Centers for Medicare & Medicaid Services risk score, and preintervention trajectories.
CONCLUSION


The postintervention adherence trajectory patterns differed from the preintervention trajectory patterns with many patients moving into an adherent trajectory especially among those receiving the intervention.",2020,"Among the intervention group, more patients in the GA preintervention trajectory (58.65%) moved to the adherent trajectory postintervention than those in the RD and GD preintervention trajectories.","['152 intervention patients and 304 randomly selected controls', 'Patients from the 3 nonadherent preintervention trajectories']",['telephonic motivational interviewing (MoI) intervention'],"['MoI intervention, prescriber specialty, presence of diabetes, presence of congestive heart failure, Centers for Medicare & Medicaid Services risk score, and preintervention trajectories', 'rapid decline (RD), gradual decline (GD), gaps in adherence (GA), and adherent', 'statin adherence']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]",,0.0167063,"Among the intervention group, more patients in the GA preintervention trajectory (58.65%) moved to the adherent trajectory postintervention than those in the RD and GD preintervention trajectories.","[{'ForeName': 'Rutugandha', 'Initials': 'R', 'LastName': 'Paranjpe', 'Affiliation': ''}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Vadhariya', 'Affiliation': ''}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'E James', 'Initials': 'EJ', 'LastName': 'Essien', 'Affiliation': ''}, {'ForeName': 'Tara W', 'Initials': 'TW', 'LastName': 'Esse', 'Affiliation': ''}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Gallardo', 'Affiliation': ''}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Serna', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Abughosh', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.06.011']
3153,32680782,Patient outcomes from implementing an enhanced services pharmacy network.,"OBJECTIVE


To evaluate the effect of implementing a network of community pharmacies on medication adherence, health service utilization, and health care spending.
DESIGN


Quasi-experimental difference-in-difference analysis with a nonequivalent control group.
SETTING AND PARTICIPANTS


Eligible Medicaid-enrolled patients in North Carolina were attributed to intervention pharmacies between March 2015 and December 2016. A control group was propensity score-matched. Interventions consisted of enhanced services and a more intensive, comprehensive initial pharmacy assessment (CIPA).
OUTCOME MEASURES


Outcomes included hospitalizations; emergency department (ED) visits; health care spending for total medical, inpatient, outpatient, and ED services; and adherence to renin-angiotensin system antagonists (RASA), statins, noninsulin diabetes medications (NIDM), and multiple medications for chronic conditions (MMCC).
RESULTS


There were 31,509 patients who met eligibility criteria and were attributed to a participating pharmacy. Of these, 3897 received a CIPA. Before matching, patients attributed to participating pharmacies had greater Medicaid enrollment through aged, blind, or disabled status (49.2% vs. 31.5%, P < 0.001); greater case management (10.3% vs. 7%, P < 0.001); and worse rates of chronic disease (P < 0.001). Successful matching removed these differences. Adherence to RASA medications and MMCC increased by 9.5% and 10.3% (P < 0.05), respectively. Adherence did not change for statins and NIDM. The analysis also revealed a slower decline in average total medical spending of 5.7% (P < 0.01) relative to the control group over the same period, owed to a 9.6% (P < 0.001) slower decline in outpatient spending. ED utilization also decreased more slowly relative to controls by 4.8% (P < 0.05) following the intervention.
CONCLUSION


The pharmacy intervention resulted in a statistically significant improvement in medication adherence to RASA and multiple chronic medications, but did not change or may have worsened utilization and spending outcomes. More research is needed to explore patient selection and variation in implementation and heterogeneity of treatment effects when evaluating pharmacy interventions.",2020,"The pharmacy intervention resulted in a statistically significant improvement in medication adherence to RASA and multiple chronic medications, but did not change or may have worsened utilization and spending outcomes.","['Eligible Medicaid-enrolled patients in North Carolina were attributed to intervention pharmacies between March 2015 and December 2016', '31,509 patients who met eligibility criteria and were attributed to a participating pharmacy']","['CIPA', 'enhanced services and a more intensive, comprehensive initial pharmacy assessment (CIPA']","['medication adherence to RASA and multiple chronic medications', 'ED utilization', 'rates of chronic disease', 'average total medical spending', 'hospitalizations; emergency department (ED) visits; health care spending for total medical, inpatient, outpatient, and ED services; and adherence to renin-angiotensin system antagonists (RASA), statins, noninsulin diabetes medications (NIDM), and multiple medications for chronic conditions (MMCC', 'Adherence to RASA medications and MMCC', 'Adherence']","[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",31509.0,0.0527363,"The pharmacy intervention resulted in a statistically significant improvement in medication adherence to RASA and multiple chronic medications, but did not change or may have worsened utilization and spending outcomes.","[{'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Urick', 'Affiliation': ''}, {'ForeName': 'Troy K', 'Initials': 'TK', 'LastName': 'Trygstad', 'Affiliation': ''}, {'ForeName': 'Joel F', 'Initials': 'JF', 'LastName': 'Farley', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.05.009']
3154,32680803,The Effects of Therapeutic Singing on Vocal Functions of the Elderly: A Study on Korean Elderly.,"This study investigated the effects of therapeutic singing as an intervention for improving the vocal functions of the elderly. Data collection for this study took place at five senior community centers in Seoul, South Korea, from August 2018 to March 2019. A total of 54 elderly with healthy voices were assigned to a therapeutic singing group, a general singing group, or a control group, using convenience sampling. The therapeutic singing intervention involved using the Alexander technique, performing oral motor and respiratory exercises, and singing participant-written songs, across 12 sessions. The general singing group sang popular and folk songs of their choice. The control group received no treatment. Using peak expiratory flow rate (PEF) and Praat analysis, the participants' vocal functions were measured before and immediately after the intervention. Vocal function was compared among the groups pre- and post-test; the therapeutic singing group showed statistically significant improvement in all vocal parameters: PEF, maximum phonation time, voice intensity (intensity), fundamental frequency (F0), jitter, shimmer, and noise-to harmonics ratio. The general singing group showed improvement only in F0, jitter, and noise-to harmonics ratio. The control group showed an overall reduction in all vocal functions, with a significant decrease in PEF and intensity, and a decrease in jitter and shimmer. Although singing is considered helpful for the voice health of the elderly, therapeutic singing, which involves posture correction and breathing exercises, is even more effective, thus proving to be a viable intervention for preventive voice care of the elderly.",2020,Vocal function was compared among the groups pre- and post-test; the therapeutic singing group showed statistically significant improvement in all vocal parameters:,"['Korean Elderly', '54 elderly with healthy voices', 'five senior community centers in Seoul, South Korea, from August 2018 to March 2019', 'Vocal Functions of the Elderly']","['therapeutic singing group, a general singing group, or a control group, using convenience sampling', 'general singing group sang popular and folk songs of their choice', 'Therapeutic Singing', 'therapeutic singing']","['PEF, maximum phonation time, voice intensity (intensity), fundamental frequency (F0), jitter, shimmer, and noise-to harmonics ratio', 'Vocal function', ""peak expiratory flow rate (PEF) and Praat analysis, the participants' vocal functions"", 'PEF and intensity', 'vocal parameters', 'F0, jitter, and noise-to harmonics ratio', 'jitter and shimmer', 'overall reduction in all vocal functions']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1532868', 'cui_str': 'Vocal function'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0872005', 'cui_str': 'Songs'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1532868', 'cui_str': 'Vocal function'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0234788', 'cui_str': 'Vocal parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",54.0,0.0122126,Vocal function was compared among the groups pre- and post-test; the therapeutic singing group showed statistically significant improvement in all vocal parameters:,"[{'ForeName': 'Soyoung', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Music Therapy, Graduate School of Interdisciplinary Therapy, Myongji University, Seoul, South Korea. Electronic address: symoon@mju.ac.kr.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Interdisciplinary Program Psychology Rehabilitation, Myongji University, Seoul, South Korea.'}, {'ForeName': 'Sua', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Interdisciplinary Program Psychology Rehabilitation, Myongji University, Seoul, South Korea.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.06.007']
3155,32681361,"Problem-solving, Adherence to Lifestyle Goals, and Weight Loss Among Individuals Participating in a Weight Loss Study.","BACKGROUND


The role of problem-solving is not well understood in behavioral weight loss interventions. In a 12-month behavioral weight loss study, we examined whether problem-solving changed over time and the relationships between problem-solving and changes in adherence to calorie, fat, and physical activity (PA) goals and percent weight change.
METHODS


One of the 24 intervention sessions (15th) was devoted to problem-solving. Participants received individualized calorie and fat goals and were given a 150 min/week moderate-to-vigorous PA goal. Adherence to calorie/fat goals and PA goals was calculated at 1, 6, and 12 months using self-reported food intake in a mobile-based weight loss app and accelerometer data, respectively. Weight was measured via a digital scale at baseline, and 6 and 12 months. A general linear model was used to compare problem-solving across time points; post hoc linear mixed modeling was used to examine the relationships between problem-solving and changes in adherence to lifestyle goals and percent weight change.
RESULTS


The sample (N = 150) was mostly female (90.7%), white (80.70%), with a mean age of 51.1 ± 10.2 years, and a mean body mass index of 34.1 + 4.6 kg/m 2 . The mean total score of problem-solving at baseline was 81.2 ± 12.3. Problem-solving total and subscale scores did not significantly change over time. Baseline problem-solving was not significantly associated with changes in adherence to lifestyle goals and percent weight change (P > 0.05).
CONCLUSION


A behavioral weight loss study did not impact problem-solving, and problem-solving may not influence lifestyle adherence and weight changes. Future work needs to examine problem-solving in larger and more diverse samples.",2020,"Baseline problem-solving was not significantly associated with changes in adherence to lifestyle goals and percent weight change (P > 0.05).
","['Individuals Participating in a Weight Loss Study', 'The sample (N\u2009=\u2009150) was mostly female (90.7%), white (80.70%), with a mean age of 51.1\u2009±\u200910.2\xa0years, and a mean body mass index of 34.1\xa0+\xa04.6\xa0kg/m 2 ']",['individualized calorie and fat goals and were given a 150\xa0min/week moderate-to-vigorous PA goal'],"['mean total score of problem-solving', 'adherence to calorie, fat, and physical activity (PA) goals and percent weight change', 'Problem-solving total and subscale scores', 'Weight', 'Problem-solving, Adherence to Lifestyle Goals, and Weight Loss', 'adherence to lifestyle goals and percent weight change']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0050286', 'cui_str': 'A 150 (plastic)'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0277659,"Baseline problem-solving was not significantly associated with changes in adherence to lifestyle goals and percent weight change (P > 0.05).
","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, PA, USA. yay60@pitt.edu.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Finegold', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Lora E', 'Initials': 'LE', 'LastName': 'Burke', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, PA, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09922-4']
3156,32681427,Painting Therapy versus Anxiolytic Premedication to Reduce Preoperative Anxiety Levels in Children Undergoing Tonsillectomy: A Randomized Controlled Trial.,,2020,,['Children'],"['Anxiolytic Premedication', 'Tonsillectomy']",['Preoperative Anxiety Levels'],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.120869,,"[{'ForeName': 'Samane', 'Initials': 'S', 'LastName': 'Babaei', 'Affiliation': 'Department of Operating Room, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Fatahi Babani', 'Affiliation': 'Department of Operating Room, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Fakhri', 'Affiliation': 'Department of Operating Room, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Mahmud43_fakhri@yahoo.com.'}, {'ForeName': 'Soodeh', 'Initials': 'S', 'LastName': 'Shahsavari', 'Affiliation': 'Department of Health Information Technology, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Parviz', 'Affiliation': 'Department of Operating Room, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Karbasfrushan', 'Affiliation': 'Department of Anesthesiology, Imam Khomeini Hospital, Imam Reza Hospital, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Etemadi', 'Affiliation': 'Department of Otorhinolaryngology, Imam Khomeini Hospital, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shirzadi', 'Affiliation': 'Department of Psychiatry, Farabi Hospital, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03430-9']
3157,32681453,Probiotics Supplementation on Cardiac Remodeling Following Myocardial Infarction: a Single-Center Double-Blind Clinical Study.,"Adverse cardiac remodeling after myocardial infarction (MI) can lead to the syndrome of heart failure (HF). Recently, changes in gut microbiota composition (dysbiosis) have appeared as a novel candidate that may be linked to the development of CR and HF. The aim of this trial was to evaluate the effects of probiotics administration on attenuating CR in patients with MI. A single-center double-blind placebo-controlled stratified randomized clinical study was conducted in 44 subjects with MI who underwent percutaneous coronary intervention (PCI). Patients were randomly assigned to take, with lunch, either a probiotic capsule containing 1.6 × 10 9  colony-forming unit (CFU) of bacteria (treatment group) or capsules contained inulin (control group) over 3 months. CR biomarkers (including serum procollagen III, transforming growth factor beta (TGF-β), trimethylamine N-oxide (TMAO), and matrix metallopeptidase 9 (MMP-9)) were assessed. Echocardiography results were measured at baseline and after the intervention. Significant decreases were seen in serum TGF-β concentrations (- 8.0 ± 2.1 vs. - 4.01 ± 1.8 pg/mL, p = 0.001) and TMAO levels (- 17.43 ± 10.20 vs. - 4.54 ± 8.7 mmol/L, p = 0.043), and there were no differences were seen in MMP-9 (- 4.1 ± 0.12 vs. - 4.01 + 0.15 nmol/mL, p = 0.443) and procollagen III levels (- 1.35 ± 0.70 vs. 0.01 + 0.3 mg/L, p = 0.392) subsequent to probiotics supplementation compared with the placebo group. Improvements in echocardiographic indices were also greater in the probiotics group as compared with that in the control group, but not at a significant level. Regression analysis revealed that baseline left ventricular ejection fraction (LVEF), and changes of procollagen III, predicted 62% of the final LVEF levels. Probiotics administration may have a beneficial effect on the cardiac remodeling process in patients with myocardial infarction. Iranian Registry of Clinical Trials (IRCT): IRCT20121028011288N15.",2020,Significant decreases were seen in serum,"['patients with MI', 'patients with myocardial infarction', 'Myocardial Infarction', 'Iranian Registry of Clinical Trials (IRCT', '44 subjects with MI who underwent percutaneous coronary intervention (PCI']","['Probiotics', 'Probiotics Supplementation', 'probiotics administration', 'probiotic capsule containing 1.6\u2009×\u200910 9  colony-forming unit (CFU) of bacteria (treatment group) or capsules contained inulin (control group) over 3\xa0months', 'placebo']","['CR biomarkers (including serum procollagen III, transforming growth factor beta (TGF-β), trimethylamine N-oxide (TMAO), and matrix metallopeptidase 9 (MMP-9', 'Cardiac Remodeling', 'serum', 'procollagen III levels', 'baseline left ventricular ejection fraction (LVEF), and changes of procollagen III', 'TGF-β concentrations', 'echocardiographic indices', 'TMAO levels', 'MMP-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0040690', 'cui_str': 'Platelet Transforming Growth Factor'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C2736430', 'cui_str': 'Matrix metallopeptidase 9'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",44.0,0.212706,Significant decreases were seen in serum,"[{'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Moludi', 'Affiliation': 'School of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran. jmoludi@yahoo.com.'}, {'ForeName': 'Somaieh', 'Initials': 'S', 'LastName': 'Saiedi', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Ebrahimi', 'Affiliation': 'Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. mdalizadeh@gmail.com.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Khajebishak', 'Affiliation': 'Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Sevda Saleh', 'Initials': 'SS', 'LastName': 'Ghadimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cardiovascular translational research,['10.1007/s12265-020-10052-1']
3158,32681455,Cerebellar Intermittent Theta-Burst Stimulation Combined with Vestibular Rehabilitation Improves Gait and Balance in Patients with Multiple Sclerosis: a Preliminary Double-Blind Randomized Controlled Trial.,"Difficulties in gait and balance disorders are among the most common mobility limitations in multiple sclerosis (MS), mainly due to a damage of cerebellar circuits. Moreover, the cerebellum plays a critical role in promoting new motor tasks, which is an essential function for neurorehabilitation. In this study, we investigated the effects of cerebellar intermittent theta burst stimulation (c-iTBS), a high-frequency rTMS protocol able to increase cerebellar activity, on gait and balance in a sample of 20 hospitalized participants with MS, undergoing vestibular rehabilitation (VR), an exercise-based program primarily designed to reduce vertigo and dizziness, gaze instability, and/or imbalance and falls in MS. Patients were assigned to receive either c-iTBS or sham iTBS before being treated with VR during 2 weeks. VR consisted of two types of training: gaze stability and postural stability exercises. The primary outcome measure was the change from baseline in the Tinetti Balance and Gait scale (TBG). The secondary outcome measures were changes from baseline in Berg Balance Scale (BBS), Fatigue Severity Scale (FSS), Two Minute Walking Test (2MWT), and Timed 25-ft walk test (T25FW) scales. MS patients treated with c-iTBS-VR showed a significant improvement in the TBG as compared to patients treated with sham iTBS-VR. Moreover, MS patients in the c-iTBS groups showed better performances in the vestibular-ocular reflex exercises. Combined c-iTBS and VR improves gait and balance abilities more than standard VR treatment in MS patients with a high level of disability.",2020,MS patients treated with c-iTBS-VR showed a significant improvement in the TBG as compared to patients treated with sham iTBS-VR.,"['20 hospitalized participants with MS, undergoing vestibular rehabilitation (VR', 'MS patients with a high level of disability', 'Patients with Multiple Sclerosis']","['Cerebellar Intermittent Theta-Burst Stimulation Combined with Vestibular Rehabilitation', 'Combined c-iTBS and VR', 'c-iTBS or sham iTBS', 'cerebellar intermittent theta burst stimulation (c-iTBS', 'training: gaze stability and postural stability exercises']","['cerebellar activity', 'Tinetti Balance and Gait scale (TBG', 'gait and balance abilities', 'Gait and Balance', 'vertigo and dizziness, gaze instability, and/or imbalance and falls in MS', 'TBG', 'changes from baseline in Berg Balance Scale (BBS), Fatigue Severity Scale (FSS), Two Minute Walking Test (2MWT), and Timed 25-ft walk test (T25FW) scales']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2732846', 'cui_str': 'Tinetti balance and gait scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",20.0,0.0318511,MS patients treated with c-iTBS-VR showed a significant improvement in the TBG as compared to patients treated with sham iTBS-VR.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Grasso', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Soldi', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Elias Paolo', 'Initials': 'EP', 'LastName': 'Casula', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bonnì', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mastrogiacomo', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': ""D'Acunto"", 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Porrazzini', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina, 306, 00179, Rome, Italy. g.koch@hsantalucia.it.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01166-y']
3159,32681688,"A comparative study of the efficacy and safety of intralesional measles, mumps, and rubella vaccine versus intralesional vitamin D3 for the treatment of warts in children.","BACKGROUND


Intralesional vitamin D3 has recently emerged as a new treatment for cutaneous warts. The use of the measles, mumps, and rubella (MMR) vaccine for this purpose is an established modality. However, relevant data on the efficacy of either the MMR vaccine or vitamin D3 as immunotherapy for cutaneous warts in the pediatric population are limited.
OBJECTIVES


To compare the efficacy and safety of intralesional injections of MMR vaccine to intralesional injections of vitamin D3 in children aged 8-16 years with multiple warts.
METHODS


A total of 74 children were randomly allocated into two groups. Group A patients received intralesional MMR vaccine into the largest wart, and group B received intralesional vitamin D3 into the largest wart. The injections were repeated every 4 weeks until clearance or for a maximum of three treatments. After the last injection, children were followed up every 2 weeks for 3 months, and at the sixth month, a final clinical assessment was conducted.
RESULTS


Of 74 children, 60 completed the study, with 30 children in each group. Complete clearance of the injected wart was observed in 26 (86.67%) patients in the MMR group (group A) and 23 (76.7%) patients in the vitamin D3 group (group B). Distant warts cleared in 23 (76.7%) patients in group A compared to 20 (66.6%) patients in group B. There was no significant difference between groups. No recurrence was seen in group A, whereas two (6.6%) children in group B exhibited recurrence in the ensuing 6-month follow-up. The most common adverse events were injection site pain and swelling.
CONCLUSION


Both intralesional MMR and vitamin D3 are safe, generally well-tolerated, and equally effective in children for the treatment of cutaneous warts.",2020,Complete clearance of the injected wart was observed in 26 (86.67%) patients in the MMR group (group A) and 23 (76.7%) patients in the vitamin D3 group (group B).,"['74 children', 'children aged 8-16\xa0years with multiple warts', 'warts in children', 'cutaneous warts', '74 children, 60 completed the study, with 30 children in each group']","['intralesional MMR vaccine', 'MMR vaccine or vitamin D3', 'intralesional vitamin D3', 'intralesional MMR and vitamin D3', 'Intralesional vitamin D3', 'MMR vaccine to intralesional injections of vitamin D3', 'vitamin D3', 'intralesional measles, mumps, and rubella vaccine versus intralesional vitamin D3']","['efficacy and safety', 'No recurrence', 'Complete clearance of the injected wart']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0035920', 'cui_str': 'Rubella'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0025007', 'cui_str': 'Measles'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]",74.0,0.0296939,Complete clearance of the injected wart was observed in 26 (86.67%) patients in the MMR group (group A) and 23 (76.7%) patients in the vitamin D3 group (group B).,"[{'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Mohta', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, GMC, Kota, India.'}, {'ForeName': 'Ramesh Kumar', 'Initials': 'RK', 'LastName': 'Kushwaha', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, GMC, Kota, India.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Gautam', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, GMC, Kota, India.'}, {'ForeName': 'Pritee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, GMC, Kota, India.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Nyati', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, GMC, Kota, India.'}, {'ForeName': 'Suresh Kumar', 'Initials': 'SK', 'LastName': 'Jain', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, GMC, Kota, India.'}]",Pediatric dermatology,['10.1111/pde.14280']
3160,32681717,The benefit of complete revascularization after primary PCI for STEMI is attenuated by increasing age: Results from the DANAMI-3-PRIMULTI randomized study.,"OBJECTIVES


To ascertain the effect of age on outcomes after culprit-only and complete revascularization after Primary PCI (PPCI) for ST-elevation myocardial infarction (STEMI).
BACKGROUND


The numbers of older patients being treated with PPCI are increasing. The optimal management of nonculprit stenoses in such patients is unclear.
METHODS


We conducted an analysis of patients aged ≥75 years randomized in the DANAMI-3-PRIMULTI study to either culprit-only or complete FFR-guided revascularization. The primary endpoint was a composite of all-cause mortality, nonfatal reinfarction, and ischaemia-driven revascularization of lesions in noninfarct-related arteries after a median of 27 months of follow-up.
RESULTS


One hundred and ten of six hundred and twenty seven patients in the DANAMI-3-PRIMULTI trial were aged ≥75 years. These patients were more likely female (p < .001), hypertensive (p < .001), had lower hemoglobin levels (p < .001), and higher serum creatinine levels (p < .001) than the younger patients in the trial. Other than less use of drug-eluting stents (96.6 versus 88.0%: p = .02), there were no significant differences in procedural technique and success between patients aged <75 years and those ≥75 years of age. There was no significant difference in the incidence of the primary endpoint in patients ≥75 years randomized to culprit-only or FFR-guided complete revascularization (HR 1.49 [95% CI 0.57-4.65]; log-rank p = .19; p for interaction versus patients <75 years <.001). There was a significant interaction between age as a continuous variable, treatment assignment, and the primary outcome (p < .001); beyond the age of about 75 years, there may be no prognostic advantage to complete revascularization.
CONCLUSIONS


In patients ≥75 years, after treatment of the culprit lesion in STEMI, there is no significant prognostic benefit to prophylactic complete revascularization of nonculprit stenoses. Pending further study, data would support a symptom-guided approach to further invasive treatment.",2020,"The primary endpoint was a composite of all-cause mortality, nonfatal reinfarction, and ischaemia-driven revascularization of lesions in noninfarct-related arteries after a median of 27 months of follow-up.
","['patients aged ≥75\u2009years randomized in the DANAMI-3-PRIMULTI study to either', 'patients aged <75\u2009years and those ≥75\u2009years of age', 'One hundred and ten of six hundred and twenty seven patients in the DANAMI-3-PRIMULTI trial were aged ≥75\u2009years']","['culprit-only or complete FFR-guided revascularization', 'culprit-only and complete revascularization after Primary PCI (PPCI']","['culprit-only or FFR-guided complete revascularization', 'composite of all-cause mortality, nonfatal reinfarction, and ischaemia-driven revascularization of lesions in noninfarct-related arteries', 'procedural technique and success', 'hemoglobin levels', 'hypertensive', 'serum creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",,0.104595,"The primary endpoint was a composite of all-cause mortality, nonfatal reinfarction, and ischaemia-driven revascularization of lesions in noninfarct-related arteries after a median of 27 months of follow-up.
","[{'ForeName': 'Francis R', 'Initials': 'FR', 'LastName': 'Joshi', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lønborg', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Sadjadieh', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Sørensen', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frants', 'Initials': 'F', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans Henrik', 'Initials': 'HH', 'LastName': 'Tilsted', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbaek', 'Affiliation': 'Department of Cardiology, Sjaellands University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29131']
3161,32681734,"Muscle structural, energetic and functional benefits of endurance exercise training in sickle cell disease.","Sickle cell disease (SCD) patients display skeletal muscle hypotrophy, altered oxidative capacity, exercise intolerance and poor quality of life. We previously demonstrated that moderate-intensity endurance training is beneficial for improving muscle function and quality of life of patients. The present study evaluated the effects of this moderate-intensity endurance training program on skeletal muscle structural and metabolic properties. Of the 40 randomized SCD patients, complete data sets were obtained from 33. The training group (n=15) followed a personalized moderate-intensity endurance training program, while the non-training (n=18) group maintained a normal lifestyle. Biopsies of the vastus lateralis muscle and submaximal incremental cycling tests were performed before and after the training program. Endurance training increased type I muscle fiber surface area (p=0.038), oxidative enzyme activity [citrate synthase, p<0.001; β-hydroxyacyl-CoA dehydrogenase, p=0.009; type-I fiber cytochrome c oxidase, p=0.042; respiratory chain complex IV, p=0.017] and contents of respiratory chain complexes I (p=0.049), III (p=0.005), IV (p=0.003) and V (p=0.002). Respiratory frequency, respiratory exchange ratio, blood lactate concentration and rating of perceived exertion were all lower at a given submaximal power output after training versus non-training group (all p<0.05). The muscle content of proteins involved in glucose transport and pH regulation were unchanged in the training group relative to the non-training group. The moderate-intensity endurance exercise program improved exercise capacity and muscle structural and oxidative properties. This trial was registered at www.clinicaltrials.gov as #NCT02571088. This article is protected by copyright. All rights reserved.",2020,The muscle content of proteins involved in glucose transport and pH regulation were unchanged in the training group relative to the non-training group.,['sickle cell disease'],"['endurance exercise training', 'personalized moderate-intensity endurance training program, while the non-training (n=18) group maintained a normal lifestyle', 'moderate-intensity endurance training', 'Endurance training', 'type-I fiber cytochrome', 'moderate-intensity endurance training program']","['Respiratory frequency, respiratory exchange ratio, blood lactate concentration and rating of perceived exertion', 'exercise capacity and muscle structural and oxidative properties', 'type I muscle fiber surface area ', 'Sickle cell disease (SCD) patients display skeletal muscle hypotrophy, altered oxidative capacity, exercise intolerance and poor quality of life', 'oxidative enzyme activity [citrate synthase, p<0.001', 'muscle content of proteins involved in glucose transport and pH regulation', 'skeletal muscle structural and metabolic properties']","[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0010798', 'cui_str': 'Cytochrome'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0242874', 'cui_str': 'Skeletal muscle fiber, type I'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",40.0,0.0227297,The muscle content of proteins involved in glucose transport and pH regulation were unchanged in the training group relative to the non-training group.,"[{'ForeName': 'Angèle N', 'Initials': 'AN', 'LastName': 'Merlet', 'Affiliation': 'Laboratoire Interuniversitaire de Biologie de la Motricité, Université de Lyon, Université Jean Monnet, Saint-Etienne, France.'}, {'ForeName': 'Léonard', 'Initials': 'L', 'LastName': 'Féasson', 'Affiliation': 'Laboratoire Interuniversitaire de Biologie de la Motricité, Université de Lyon, Université Jean Monnet, Saint-Etienne, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Bartolucci', 'Affiliation': 'Service de Médecine Interne Hôpital Henri-Mondor (AP-HP), Université Paris-Est Créteil (UPEC), Créteil, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hourdé', 'Affiliation': 'Laboratoire Interuniversitaire de Biologie de la Motricité, Université Savoie Mont Blanc, Chambéry, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Schwalm', 'Affiliation': 'Institute of Neuroscience Université Catholique de Louvain, Louvain-la-Neuve, Belgique.'}, {'ForeName': 'Barnabas', 'Initials': 'B', 'LastName': 'Gellen', 'Affiliation': 'Service de Réhabilitation Cardiaque Hôpital Henri-Mondor (Assistance Publique-Hôpitaux de Paris [APHP]), Créteil, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Galactéros', 'Affiliation': 'Service de Santé Publique Hôpital Henri-Mondor (AP-HP), UPEC, Créteil, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': 'Institute of Neuroscience Université Catholique de Louvain, Louvain-la-Neuve, Belgique.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Francaux', 'Affiliation': 'Institute of Neuroscience Université Catholique de Louvain, Louvain-la-Neuve, Belgique.'}, {'ForeName': 'Laurent A', 'Initials': 'LA', 'LastName': 'Messonnier', 'Affiliation': 'Laboratoire Interuniversitaire de Biologie de la Motricité, Université Savoie Mont Blanc, Chambéry, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of hematology,['10.1002/ajh.25936']
3162,31822477,Implementing a junior high school-based programme to reduce sports injuries through neuromuscular training (iSPRINT): a cluster randomised controlled trial (RCT).,"OBJECTIVE


To evaluate the effectiveness of a junior high school-based sports injury prevention programme to reduce injuries through neuromuscular training (NMT).
METHODS


This was a cluster randomised controlled trial. Students were recruited from 12 Calgary junior high schools (2014-2017). iSPRINT is a 15 min NMT warm-up including aerobic, agility, strength and balance exercises. Following a workshop, teachers delivered a 12-week iSPRINT NMT (six schools) or a standard-of-practice warm-up (six schools) in physical education classes. The definition of all recorded injuries included injuries that resulted in participants being unable to complete a sport and recreation (S&R) session, lost time from sport and/or seek medical attention. Incidence rate ratios (IRRs) were estimated based on multiple multilevel Poisson regression analyses (adjusting for sex (considering effect modification) and previous injury, offset by S&R participation hours, and school-level and class-level random effects were examined) for intent-to-treat analyses.
RESULTS


1067 students (aged 11-16) were recruited across 12 schools (6 intervention schools (22 classes), 6 control schools (27 classes); 53.7% female, 46.3% male). The iSPRINT programme was protective of all recorded S&R injuries for girls (IRR=0.543, 95% CI 0.295 to 0.998), but not for boys (IRR=0.866, 95% CI 0.425 to 1.766). The iSPRINT programme was also protective of each of lower extremity injuries (IRR=0.357, 95% CI 0.159 to 0.799) and medical attention injuries (IRR=0.289, 95% CI 0.135 to 0.619) for girls, but not for boys (IRR=1.055, 95% CI 0.404 to 2.753 and IRR=0.639, 95% CI 0.266 to 1.532, respectively).
CONCLUSION


The iSPRINT NMT warm-up was effective in preventing each of all recorded injuries, lower extremity injuries and medically treated S&R injuries in female junior high school students.
TRIAL REGISTRATION NUMBER


NCT03312504.",2020,"The iSPRINT programme was protective of all recorded S&R injuries for girls (IRR=0.543, 95% CI 0.295 to 0.998), but not for boys (IRR=0.866, 95% CI 0.425 to 1.766).","['1067 students (aged 11-16) were recruited across 12 schools (6 intervention schools (22 classes), 6 control schools (27 classes); 53.7% female, 46.3% male', 'Students were recruited from 12 Calgary junior high schools (2014-2017', 'female junior high school students']","['neuromuscular training (iSPRINT', '12-week iSPRINT NMT (six schools) or a standard-of-practice warm-up (six schools) in physical education classes', 'junior high school-based sports injury prevention programme']","['medical attention injuries', 'extremity injuries', 'Incidence rate ratios (IRRs']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004161', 'cui_str': 'Sports injury'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0743668', 'cui_str': 'Limb injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.058628,"The iSPRINT programme was protective of all recorded S&R injuries for girls (IRR=0.543, 95% CI 0.295 to 0.998), but not for boys (IRR=0.866, 95% CI 0.425 to 1.766).","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Emery', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada caemery@ucalgary.ca.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'van den Berg', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sarah Ann', 'Initials': 'SA', 'LastName': 'Richmond', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Palacios-Derflingher', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Carly D', 'Initials': 'CD', 'LastName': 'McKay', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Doyle-Baker', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McKinlay', 'Affiliation': 'Ever Active Schools, Calgary, Alberta, Canada.'}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Toomey', 'Affiliation': 'Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Departments of Pediatrics and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Collaboration for Health and Safety in Sports, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Belton', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Macpherson', 'Affiliation': 'Faculty of Health, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Brent E', 'Initials': 'BE', 'LastName': 'Hagel', 'Affiliation': 'Departments of Pediatrics and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101117']
3163,31870453,"""The role as a champion is to not only monitor but to speak out and to educate"": the contradictory roles of hand hygiene champions.","BACKGROUND


Implementation science experts define champions as ""supporting, marketing, and driving through an implementation, overcoming indifference or resistance that the intervention may provoke in an organization."" Many hospitals use designated clinical champions-often called ""hand hygiene (HH) champions""-typically to improve hand hygiene compliance. We conducted an ethnographic examination of how infection control teams in the Veterans Health Administration (VHA) use the term ""HH champion"" and how they define the role.
METHODS


An ethnographic study was conducted with infection control teams and frontline staff directly involved with hand hygiene across 10 geographically dispersed VHA facilities in the USA. Individual and group semi-structured interviews were conducted with hospital epidemiologists, infection preventionists, multi-drug-resistant organism (MDRO) program coordinators, and quality improvement specialists and frontline staff from June 2014 to September 2017. The team coded the transcripts using thematic content analysis content based on a codebook composed of inductive and deductive themes.
RESULTS


A total of 173 healthcare workers participated in interviews from the 10 VHA facilities. All hand hygiene programs at each facility used the term HH champion to define a core element of their hand hygiene programs. While most described the role of HH champions as providing peer-to-peer coaching, delivering formal and informal education, and promoting hand hygiene, a majority also included hand hygiene surveillance. This conflation of implementation strategies led to contradictory responsibilities for HH champions. Participants described additional barriers to the role of HH champions, including competing priorities, staffing hierarchies, and turnover in the role.
CONCLUSIONS


Healthcare systems should consider narrowly defining the role of the HH champion as a dedicated individual whose mission is to overcome resistance and improve hand hygiene compliance-and differentiate it from the role of a ""compliance auditor."" Returning to the traditional application of the implementation strategy may lead to overall improvements in hand hygiene and reduction of the transmission of healthcare-acquired infections.",2019,All hand hygiene programs at each facility used the term HH champion to define a core element of their hand hygiene programs.,"['173 healthcare workers participated in interviews from the 10 VHA facilities', 'Veterans Health Administration (VHA']",[],[],"[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}]",[],[],,0.0207289,All hand hygiene programs at each facility used the term HH champion to define a core element of their hand hygiene programs.,"[{'ForeName': 'Cassie Cunningham', 'Initials': 'CC', 'LastName': 'Goedken', 'Affiliation': 'Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Hwy 6 West, Iowa City, 52246, USA. cassie.goedken@va.gov.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Livorsi', 'Affiliation': 'Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Hwy 6 West, Iowa City, 52246, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sauder', 'Affiliation': 'Department of Sociology, University of Iowa, 140 Seashore Hall West, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Hwy 6 West, Iowa City, 52246, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Chasco', 'Affiliation': 'Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Hwy 6 West, Iowa City, 52246, USA.'}, {'ForeName': 'Nai-Chung', 'Initials': 'NC', 'LastName': 'Chang', 'Affiliation': 'University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Perencevich', 'Affiliation': 'Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Hwy 6 West, Iowa City, 52246, USA.'}, {'ForeName': 'Heather Schacht', 'Initials': 'HS', 'LastName': 'Reisinger', 'Affiliation': 'Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, 601 Hwy 6 West, Iowa City, 52246, USA.'}]",Implementation science : IS,['10.1186/s13012-019-0943-x']
3164,32682074,Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects.,"This gamma scintigraphy imaging study assessed pulmonary, extrathoracic and regional lung deposition patterns of a radiolabelled inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist triple fixed-dose combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF 320/14.4/10 μg), delivered by pressurised metered dose inhaler (pMDI) using innovative co-suspension delivery technology (Aerosphere™). In this Phase I, randomised, single-centre, single-dose, two-period, crossover study (NCT03740373), 10 healthy male adults received two actuations of BGF MDI (160/7.2/4.8 μg per actuation) radiolabelled with  99m Tc, not exceeding 5 MBq per actuation. Immediately following each inhalation, subjects performed a 10- or 3-second breath-hold, then exhaled into an exhalation filter. The primary objective was to assess the pulmonary deposition of BGF MDI following the 10-second breath-hold. The secondary objectives were to assess deposition after the 3-second breath-hold and lung regional and extrathoracic deposition after each breath-hold length. Imaging of the lungs, stomach, head and neck was recorded by gamma scintigraphy immediately after exhalation. The mean BGF MDI emitted dose deposited in the lungs was 37.7% for the 10-second breath-hold and 34.5% for the 3-second breath-hold. Emitted dose detected in the exhalation filter was ≤0.4% for both breath-hold lengths. The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively. There were no new or unexpected safety findings. In conclusion, BGF MDI was efficiently deposited in the central and the peripheral regions of the lungs, with similar regional deposition patterns following a 10- and 3-second breath-hold.",2020,"The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively.","['10 healthy male adults received', 'healthy male subjects']","['two actuations of BGF MDI', 'budesonide/glycopyrronium/formoterol fumarate dihydrate']","['exhalation filter', 'deposition after the 3-second breath-hold and lung regional and extrathoracic deposition after each breath-hold length', 'mean BGF MDI', 'pulmonary deposition of BGF MDI', 'mean normalised peripheral/central ratio', 'BGF MDI']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C1579393', 'cui_str': 'Formoterol fumarate dihydrate'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",10.0,0.0611695,"The mean normalised peripheral/central ratio was 0.65 and 0.75 for the 10- and 3-second breath-holds, respectively, while the standardised central/peripheral ratios were 1.79 and 1.40, respectively.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Israel', 'Affiliation': 'Simbec Research Ltd, Merthyr Tydfil, South Wales, CF48 4DR, UK.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Kelly Services Global LLC, Suite 401A, 999 W. Big Beaver Rd., Troy, MI 48084, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'Formerly of AstraZeneca, 4222 Emperor Blvd, Suite 560, Durham, NC 27703, USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'AstraZeneca Gothenburg, Pepparedsleden 1, SE-431 50, Mölndal, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, 4222 Emperor Blvd, Suite 560, Durham, NC 27703, USA. Electronic address: paul.dorinsky1@astrazeneca.com.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Respiratory Medicine, Hôpital Cochin (AP-HP), University Paris Descartes, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Usmani', 'Affiliation': 'National Heart and Lung Institute (NHLI), Imperial College London & Royal Brompton Hospital, Guy Scadding Building, Dovehouse St, Chelsea, London, SW3 6LY, UK.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105472']
3165,32682174,The renin secretion profile under the influence of sleep deprivation and the neuropeptides CRH and GHRH.,"It is already known that during normal sleep plasma renin activity (PRA) shows oscillations with decreases during rapid-eye-movement (REM) sleep and increases during non-REM (NREM) sleep. We also know that renin correlates positively with slow-wave sleep (SWS). Sleep deprivation is known to enhance significantly SWS and slow wave activity (SWA, known as δ power). Based on these findings we addressed the question whether and to which extent sleep deprivation may affect the synchronization found between PRA and REM sleep during normal sleep and whether this synchronization is affected by other sleep regulating factors. To investigate these questions we compared sleep EEG and sleep-related free renin levels in 48 normal women and men 19-69 years old between nights before and after 40 h of sleep deprivation. During the recovery night, four bolus injections of either GHRH, CRH or placebo were injected via long catheter around sleep onset. When compared to baseline after each of the treatments SWS, SWA and renin levels increased. The characteristical oscillation profiles of renin during normal sleep were also preserved after sleep deprivation. Similar to normal sleep our data support also a distinct link between nocturnal renin secretion and SWS after sleep deprivation and that independent of the applied treatments.",2020,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.",['48 normal women and men 19-69 years old between nights before and after 40\u2009h of sleep deprivation'],"['GHRH, CRH or placebo']","['renin correlates positively with slow-wave sleep (SWS', 'SWA and renin levels', 'sleep EEG and sleep-related free renin levels']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",48.0,0.0236425,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Künzel', 'Affiliation': 'Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Germany; Max-Planck-Institut für Psychiatrie München, Germany. Electronic address: Heike.Kuenzel@med.uni-muenchen.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schüssler', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Regensburg, Klinik und Poliklinik für Psychiatrie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yassouridis', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uhr', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kluge', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Steiger', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104799']
3166,32682277,Effects of repeated exposure to fearful and disgusting stimuli on fear renewal in blood-injection-injury phobia.,"Although exposure is effective for blood-injection-injury (BII) phobia, fear often returns after treatment. While disgust has been implicated in BII phobia, its effects on fear renewal are unclear. To address this knowledge gap, the present study examined the effect of repeated video exposure to fearful and disgusting stimuli in multiple contexts on fear renewal in BII phobia. Individuals with BII phobia (N = 57) were randomized to Disgust-Specific Exposure (DSE) which included exposure to disgusting but threat-irrelevant stimuli (i.e., vomit), Fear-Specific Exposure (FSE) which included exposure to threat-relevant stimuli (i.e., injections), or General Negative Exposure (GNE) which included exposure designed to elicit negative affect (i.e., tornado) without being disgusting or threat-relevant. During session one, participants watched a pre- and post-exposure assessment injection video (""pre/post assessment""), and a novel injection video after exposure to assess renewal effects (""novel 1""). Participants came in one week later to rate the same videos, and a new injection video (""novel 2""). For week one outcomes, comparisons of covariate adjusted means indicated the fear-specific group reported significantly lower levels of anxiety than the general-negative group to the post-exposure and novel 1 stimulus. When presented with the post-exposure stimuli during week two, the disgust-specific and fear-specific groups reported significantly lower levels of anxiety than the general negative group. The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two. These findings suggest that repeated exposure to threat-relevant cues in multiple contexts does reduce the return of anxiety. However, repeated exposure to disgusting but threat irrelevant stimuli may also produce some therapeutic effects. The implications of the integration of disgust-relevant processes into exposure-based treatment of BII phobia are discussed.",2020,The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two.,"['Individuals with BII phobia (N = 57', 'blood-injection-injury phobia', 'multiple contexts on fear renewal in BII phobia']","['Disgust-Specific Exposure (DSE) which included exposure to disgusting but threat-irrelevant stimuli (i.e., vomit), Fear-Specific Exposure (FSE) which included exposure to threat-relevant stimuli (i.e., injections), or General Negative Exposure', 'repeated exposure to fearful and disgusting stimuli', 'pre- and post-exposure assessment injection video (""pre/post assessment']","['return of anxiety', 'levels of anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",57.0,0.00929875,The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two.,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Jessup', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tomarken', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Viar-Paxton', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Bunmi O', 'Initials': 'BO', 'LastName': 'Olatunji', 'Affiliation': 'Vanderbilt University, United States. Electronic address: olubunmi.o.olatunji@vanderbilt.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102272']
3167,32682347,A PERIOD3 variable-number-tandem-repeat polymorphism modulates melatonin treatment response in Delayed Sleep-Wake Phase Disorder.,"We examined whether a polymorphism of the PERIOD3 gene (PER3; rs57875989) modulated the sleep promoting effects of melatonin in Delayed Sleep-Wake Phase Disorder (DSWPD). One hundred and four individuals (53 males; 29.4±10.0 years) with DSWPD and a delayed dim light melatonin onset (DLMO) collected buccal swabs for genotyping (PER3 4/4  n=43; PER3 5 allele [heterozygous and homozygous] n=60). Participants were randomised to placebo or 0.5mg melatonin taken 1 hour before desired bedtime (or ~ 1.45 h before DLMO), with sleep attempted at desired bedtime (4 weeks; 5-7 nights/week). We assessed sleep (diary and actigraphy), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient-Reported Outcomes Measurement Information System (PROMIS: Sleep Disturbance, Sleep-Related Impairment), Sheehan Disability Scale (SDS), and Patient- and Clinician-Global Improvement (PGI-C, CGI-C). Melatonin treatment response on actigraphic sleep onset time did not differ between genotypes. For PER3 4/4  carriers, self-reported sleep onset time was advanced by a larger amount and sleep onset latency (SOL) was shorter in melatonin-treated patients compared to those receiving placebo (P=0.008), while actigraphic sleep efficiency in the first third of the sleep episode (SE T1) did not differ. For PER3 5 carriers, actigraphic SOL and SE T1 showed a larger improvement with melatonin (P<0.001). Melatonin improved ISI (P=0.005), PROMIS Sleep Disturbance (P<0.001) and Sleep-Related Impairment (P=0.017), SDS (P=0.019), PGI-C (P=0.028), and CGI-C (P=0.016) in PER3 4/4  individuals only. Melatonin did not advance circadian phase. Overall, PER3 4/4  DSWPD patients have a greater response to melatonin treatment. PER3 genotyping may therefore improve DSWPD patient outcomes.",2020,"Melatonin improved ISI (P=0.005), PROMIS Sleep Disturbance (P<0.001) and Sleep-Related Impairment (P=0.017), SDS (P=0.019), PGI-C (P=0.028), and CGI-C (P=0.016) in PER3 4/4  individuals only.","['Delayed Sleep-Wake Phase Disorder', 'Delayed Sleep-Wake Phase Disorder (DSWPD', 'One hundred and four individuals (53 males; 29.4±10.0 years) with DSWPD and a delayed dim light melatonin onset (DLMO) collected buccal swabs for genotyping (PER3 4/4  n=43']","['placebo or 0.5mg melatonin', 'melatonin', 'Melatonin', 'placebo']","['sleep (diary and actigraphy), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient-Reported Outcomes Measurement Information System (PROMIS: Sleep Disturbance, Sleep-Related Impairment), Sheehan Disability Scale (SDS), and Patient- and Clinician-Global Improvement (PGI-C, CGI-C', 'sleep onset latency (SOL', 'ISI', 'actigraphic sleep efficiency', 'Sleep-Related Impairment', 'PGI-C', 'actigraphic sleep onset time', 'PROMIS Sleep Disturbance']","[{'cui': 'C0393770', 'cui_str': 'Sleep-wake schedule disorder, delayed phase type'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0581714', 'cui_str': 'Buccal smear procedure'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}]",104.0,0.188696,"Melatonin improved ISI (P=0.005), PROMIS Sleep Disturbance (P<0.001) and Sleep-Related Impairment (P=0.017), SDS (P=0.019), PGI-C (P=0.028), and CGI-C (P=0.016) in PER3 4/4  individuals only.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Magee', 'Affiliation': 'Turner Institute for Brain and Mental Health and School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Sletten', 'Affiliation': 'Turner Institute for Brain and Mental Health and School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Murray', 'Affiliation': 'Turner Institute for Brain and Mental Health and School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lovato', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kennaway', 'Affiliation': 'Robinson Research Institute, Adelaide School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': 'Turner Institute for Brain and Mental Health and School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leon C', 'Initials': 'LC', 'LastName': 'Lack', 'Affiliation': 'Adelaide Institute for Sleep Health: A Flinders Centre of Research Excellence, School of Medicine, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Archer', 'Affiliation': 'Surrey Sleep Research Centre, Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, UK.'}, {'ForeName': 'Shantha Mw', 'Initials': 'SM', 'LastName': 'Rajaratnam', 'Affiliation': 'Turner Institute for Brain and Mental Health and School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pineal research,['10.1111/jpi.12684']
3168,32682357,Effects of different epidural initiation volumes on postoperative analgesia in cesarean section.,"BBackgrounds: The aim of this study was to compare the effects of different epidural initiation volumes on the postoperative pain scores, analgesic requirements, and side effects in pregnant women administered patient controlled epidural analgesia (PCEA) for postoperative pain after cesarean sections.
MATERIALS AND METHODS


Eighty-one pregnant women, aged 18-45 years old, were included in this randomized, double-blinded study. Combined spinal epidural anesthesia was administered for each cesarean section. The patients were divided into three groups and different volumes (20 ml, 10 ml, and 5 ml) of study drug (0.0625% bupivacaine plus 2 ?g/ml of fentanyl) were administered ninety minutes after the spinal block via epidural catheter. The visual analogue scale (VAS) scores at rest and during movement, first PCEA dose time, number of PCEA doses required per hour, total analgesic consumed and side effects were recorded postoperatively.
RESULTS


There were no statistically significant differences among the groups in terms of the VAS rest and VAS movement scores. The times to the first analgesic dose requirement were longer in Group 10 and Group 20 than in Group 5. The analgesic requirement during the first 2 hours was lower in Group 20 than in the other groups.
CONCLUSIONS


The PCEA initiations with different volumes provided similar pain scores. However, the 20 ml volume resulted in a lower analgesic dose requirement during the early postoperative period, and it also delayed the requirement for analgesia.",2020,There were no statistically significant differences among the groups in terms of the VAS rest and VAS movement scores.,"['pregnant women administered patient', 'Eighty-one pregnant women, aged 18-45 years old', 'cesarean section']","['bupivacaine', 'controlled epidural analgesia (PCEA', 'epidural initiation volumes', 'Combined spinal epidural anesthesia', 'fentanyl']","['pain scores', 'VAS rest and VAS movement scores', 'postoperative pain scores, analgesic requirements, and side effects', 'visual analogue scale (VAS) scores at rest and during movement, first PCEA dose time, number of PCEA doses required per hour, total analgesic consumed and side effects', 'analgesic requirement']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",81.0,0.103614,There were no statistically significant differences among the groups in terms of the VAS rest and VAS movement scores.,"[{'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Kacmaz', 'Affiliation': ''}, {'ForeName': 'Nurcin', 'Initials': 'N', 'LastName': 'Gulhas', 'Affiliation': ''}, {'ForeName': 'Gulay', 'Initials': 'G', 'LastName': 'Erdogan Kayhan', 'Affiliation': ''}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Durmus', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-1905-44']
3169,32682361,"COMPARISON OF THE CLINICAL AND SONOGRAPHIC EFFECTS OF ULTRASOUND THERAPY, EXTRACORPOREAL SHOCK WAVE THERAPY AND KINESIO TAPING IN LATERAL EPICONDYLITIS.","BACKGROUND/AIM


The aim of this study was to compare the clinical and sonographic effects of the ultrasound (US) therapy, extracorporeal shock wave therapy (ESWT), and Kinesio taping (KT) in the lateral epicondylitis (LE).
MATERIALS AND METHODS


A total of 40 patients with LE were included in the present study. The patients were randomly assigned to three treatment groups: US (n = 13), ESWT (n = 14), and KT (n = 13) groups.
RESULTS


The visual analog scale (VAS) scores significantly decreased in all groups (p < 0.05). Grip strength significantly increased after eight weeks in only the KT group (p < 0.05). The Patient-Rated Tennis Elbow Evaluation Scale (PRTEE) scores significantly decreased after two weeks and after eight weeks in the US and ESWT groups and after eight weeks in the KT group (p < 0.05). The common extensor tendon (CET) thicknesses significantly decreased after eight weeks in only the ESWT group (p < 0.05).
CONCLUSION


The US therapy, KT, and ESWT are effective in reducing pain and improving functionality. However, none of these treatment methods were found to be superior to the others in reducing the pain and improving functionality.",2020,The Patient-Rated Tennis Elbow Evaluation Scale (PRTEE) scores significantly decreased after two weeks and after eight weeks in the US and ESWT groups and after eight weeks in the KT group (p < 0.05).,['40 patients with LE'],"['ultrasound (US) therapy, extracorporeal shock wave therapy (ESWT), and Kinesio taping (KT', 'ESWT']","['visual analog scale (VAS) scores', 'Patient-Rated Tennis Elbow Evaluation Scale (PRTEE) scores', 'Grip strength', 'pain and improving functionality', 'common extensor tendon (CET) thicknesses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}]","[{'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0224849', 'cui_str': 'Structure of extensor tendon'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",40.0,0.0150574,The Patient-Rated Tennis Elbow Evaluation Scale (PRTEE) scores significantly decreased after two weeks and after eight weeks in the US and ESWT groups and after eight weeks in the KT group (p < 0.05).,"[{'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Özmen', 'Affiliation': ''}, {'ForeName': 'Salİh SÜha', 'Initials': 'SS', 'LastName': 'Koparal', 'Affiliation': ''}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'KarataŞ', 'Affiliation': ''}, {'ForeName': 'Fİlİz', 'Initials': 'F', 'LastName': 'Eser', 'Affiliation': ''}, {'ForeName': 'BÜlent', 'Initials': 'B', 'LastName': 'Özkurt', 'Affiliation': ''}, {'ForeName': 'Tuba Ümİt', 'Initials': 'TÜ', 'LastName': 'GafuroĞlu', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-2001-79']
3170,31058286,Non-pharmacological Considerations in Human Research of Nicotine and Tobacco Effects: A Review.,"Human research of nicotine and tobacco effects demonstrates that non-pharmacological factors may systematically affect responses to administered substances and inert placebos. Failure to measure or manipulate these factors may compromise study reliability and validity. This is especially relevant for double-blind placebo-controlled research of nicotine, tobacco, and related substances. In this article, we review laboratory-based human research of the impact of non-pharmacological factors on responses to tobacco and nicotine administration. Results suggest that varying beliefs about drug content and effects, perceptions about drug use opportunities, and intentions to cease drug use systematically alter subjective, behavioral, and physiological responses to nicotine, tobacco, and placebo administration. These non-pharmacological factors should be considered when designing and interpreting the findings of human research of nicotine and tobacco effects, particularly when a double-blind placebo-controlled design is used. The clinical implications of these findings are discussed, and we propose methodological strategies to enhance the reliability and validity of future research.
IMPLICATIONS


Growing research demonstrates that non-pharmacological factors systematically alter responses to acute nicotine, tobacco, and placebo administration. Indeed, varying beliefs about nicotine and/or tobacco administration and effects, differing perceptions about nicotine and/or tobacco use opportunities, and inconsistent motivation to quit smoking have been found to exert important influences on subjective, physiological, and behavioral responses. These variables are infrequently measured or manipulated in nicotine and tobacco research, which compromises the validity of study findings. Incorporating methodological strategies to better account for these non-pharmacological factors has the potential to improve the quality of addiction research and treatment.",2020,"Results suggest that varying beliefs about drug content and effects, perceptions about drug use opportunities, and intentions to cease drug use systematically alter subjective, behavioural, and physiological responses to nicotine, tobacco, and placebo administration.",[],[],[],[],[],[],,0.0672145,"Results suggest that varying beliefs about drug content and effects, perceptions about drug use opportunities, and intentions to cease drug use systematically alter subjective, behavioural, and physiological responses to nicotine, tobacco, and placebo administration.","[{'ForeName': 'Hera E', 'Initials': 'HE', 'LastName': 'Schlagintweit', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Darredeau', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz064']
3171,31021112,Common variants of the oxytocin receptor gene do not predict the positive mood benefits of prosocial spending.,"Who benefits most from helping others? Previous research suggests that common polymorphisms of the oxytocin receptor gene (OXTR) predict whether people behave generously and experience increases in positive mood in response to socially focused experiences in daily life. Building on these findings, we conducted an experiment with a large, ethnically homogenous sample (N = 437) to examine whether individual differences in three frequently studied single nucleotide polymorphisms of OXTR (rs53576, rs2268498, rs2254298) also predict differences in the positive mood benefits of financial generosity. Consistent with past research, participants who were randomly assigned to purchase items for others (vs. themselves) reported greater positive affect. Contrary to predictions, using Bayesian statistics, we found conclusive evidence that the benefits of generosity were not moderated by individual differences in OXTR single nucleotide polymorphisms. The current work highlights the importance of publishing null results to build cumulative knowledge linking neurobiological factors to positive emotional experiences. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Contrary to predictions, using Bayesian statistics, we found conclusive evidence that the benefits of generosity were not moderated by individual differences in OXTR single nucleotide polymorphisms.",[],[],[],[],[],[],,0.324381,"Contrary to predictions, using Bayesian statistics, we found conclusive evidence that the benefits of generosity were not moderated by individual differences in OXTR single nucleotide polymorphisms.","[{'ForeName': 'Ashley V', 'Initials': 'AV', 'LastName': 'Whillans', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lara B', 'Initials': 'LB', 'LastName': 'Aknin', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Ross', 'Affiliation': 'Department of Pharmaceutical Sciences.'}, {'ForeName': 'Lihan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000589']
3172,30907290,Actors in whitespace: Communicating risk information on pharmaceutical websites.,"This study examined the use of an actor to communicate prescription drug risks on pharmaceutical websites. Participants viewed risk information for a fictitious drug in one of several static visual formats or as a paragraph plus an animated actor; and with or without a signal directing them to the risk information text. The signal had little effect on outcomes. Format did not affect risk processing, but participants in the actor condition thought the website placed less emphasis on benefits. Actors communicating risk information on a pharmaceutical website do not appear to improve consumers' understanding of prescription drug information.",2019,Actors communicating risk information on a pharmaceutical website do not appear to improve consumers' understanding of prescription drug information.,[],['paragraph plus an animated actor; and with or without a signal directing them to the risk information text'],[],[],"[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0335083', 'cui_str': 'Actor (occupation)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}]",[],,0.0224726,Actors communicating risk information on a pharmaceutical website do not appear to improve consumers' understanding of prescription drug information.,"[{'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': 'a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}, {'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': 'a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rupert', 'Affiliation': 'b RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fitts Willoughby', 'Affiliation': 'b RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}]",Health marketing quarterly,['10.1080/07359683.2019.1575063']
3173,31310839,How to improve the clinical experience for dermatology patients requiring a genital examination: A randomized trial of deodorizing wipes versus standard of care.,,2020,,['Dermatology Patients Requiring a Genital Examination'],['Deodorizing Wipes versus Standard of Care'],[],"[{'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}]",[],,0.02847,,"[{'ForeName': 'Susruthi', 'Initials': 'S', 'LastName': 'Rajanala', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Burdine', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Mayra B C', 'Initials': 'MBC', 'LastName': 'Maymone', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Neelam A', 'Initials': 'NA', 'LastName': 'Vashi', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts; US Department of Veterans Affairs, Boston Health Care System, Boston, Massachusetts. Electronic address: nvashi@bu.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.026']
3174,27581088,Phase II trial of nab-paclitaxel in patients with relapsed or refractory multiple myeloma.,,2016,,['patients with relapsed or refractory multiple myeloma'],['nab-paclitaxel'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]",[],,0.0119195,,"[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Jain', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Kosiorek', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Ginos', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mayo', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Reeder', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Chesi', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mikhael', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Keith Stewart', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Leif Bergsagel', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona.'}]",American journal of hematology,['10.1002/ajh.24548']
3175,31424631,Oncology phase II proof-of-concept studies with multiple targets: Randomized controlled trial or single arm?,"For oncology drug development, phase II proof-of-concept studies have played a key role in determining whether or not to advance to a confirmatory phase III trial. With the increasing number of immunotherapies, efficient design strategies are crucial in moving successful drugs quickly to market. Our research examines drug development decision making under the framework of maximizing resource investment, characterized by benefit cost ratios (BCRs). In general, benefit represents the likelihood that a drug is successful, and cost is characterized by the risk adjusted total sample size of the phases II and III studies. Phase III studies often include a futility interim analysis; this sequential component can also be incorporated into BCRs. Under this framework, multiple scenarios can be considered. For example, for a given drug and cancer indication, BCRs can yield insights into whether to use a randomized control trial or a single-arm study. Importantly, any uncertainty in historical control estimates that are used to benchmark single-arm studies can be explicitly incorporated into BCRs. More complex scenarios, such as restricted resources or multiple potential cancer indications, can also be examined. Overall, BCR analyses indicate that single-arm trials are favored for proof-of-concept trials when there is low uncertainty in historical control data and smaller phase III sample sizes. Otherwise, especially if the most likely to succeed tumor indication can be identified, randomized controlled trials may be a better option. While the findings are consistent with intuition, we provide a more objective approach.",2020,"For example, for a given drug and cancer indication, BCRs can yield insights into whether to use a randomized control trial or a single-arm study.",[],[],[],[],[],[],,0.0393593,"For example, for a given drug and cancer indication, BCRs can yield insights into whether to use a randomized control trial or a single-arm study.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jemielita', 'Affiliation': 'Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Archie', 'Initials': 'A', 'LastName': 'Tse', 'Affiliation': 'Translation Medicine, CStone Pharmaceuticals, Suzhou, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Pharmaceutical statistics,['10.1002/pst.1972']
3176,31116468,Issues in the determination of 'responders' and 'non-responders' in physiological research.,"NEW FINDINGS


What is the topic for this review? We discuss the dichotomization of continuous-level physiological measurements into 'responders' and 'non-responders' when interventions/treatments are examined in robust parallel-group studies. What advances does it highlight? Sample responder counts are biased by pre-to-post within-subject variability. Sample differences in counts may be explained wholly by differences in mean response, even without individual response heterogeneity and even if test-retest measurement error informs the choice of response threshold. A less biased and more informative approach uses the SD of individual responses to estimate the chance a new person from the population of interest will be a responder.
ABSTRACT


As a follow-up to our 2015 review, we cover more issues on the topic of 'response heterogeneity', which we define as clinically important individual differences in the physiological responses to the same treatment/intervention that cannot be attributed to random within-subject variability. We highlight various pitfalls with the common practice of counting the number of 'responders', 'non-responders' and 'adverse responders' in samples that have been given certain treatments or interventions for research purposes. We focus on the classical parallel-group randomized controlled trial and assume typical good practice in trial design. We show that sample responder counts are biased because individuals differ in terms of pre-to-post within-subject random variability in the study outcome(s) and not necessarily treatment response. Ironically, sample differences in responder counts may be explained wholly by sample differences in mean response, even if there is no response heterogeneity at all. Sample comparisons of responder counts also have relatively low statistical precision. These problems do not depend on how the response threshold has been selected, e.g. on the basis of a measurement error statistic, and are not rectified fully by the use of confidence intervals for individual responses in the sample. The dichotomization of individual responses in a research sample is fraught with pitfalls. Less biased approaches for estimating the proportion of responders in a population of interest are now available. Importantly, these approaches are based on the SD for true individual responses, directly incorporating information from the control group.",2019,"A less biased and more informative approach uses the SD of individual responses to estimate the chance a new person from the population of interest will be a responder.
",[],[],[],[],[],[],,0.0546727,"A less biased and more informative approach uses the SD of individual responses to estimate the chance a new person from the population of interest will be a responder.
","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Atkinson', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'Faculty of Health Sciences, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Batterham', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}]",Experimental physiology,['10.1113/EP087712']
3177,31125735,Insights for Management of Ground-Glass Opacities From the National Lung Screening Trial.,"BACKGROUND


In the National Lung Screening Trial (NLST), screen-detected cancers that would not have been identified by the Lung Computed Tomographic Screening Reporting and Data System (Lung-RADS) nodule management guidelines were frequently ground-glass opacities (GGOs). Lung-RADS suggests that GGOs with diameter less than 20 mm return for annual screening, and GGOs greater than or equal to 20 mm receive 6-month follow-up. We examined whether this 20-mm threshold gives consistent management of GGOs compared with solid nodules.
METHODS


First, we calculated diameter-specific malignancy probabilities for GGOs and solid nodules in the NLST. Using the solid-nodule malignancy risks as benchmarks, we suggested risk-based management categories for GGOs based on their probability of malignancy. Second, we compared lung-cancer mortality between GGOs and solid nodules in the same risk-based category.
RESULTS


Using the Lung-RADS v1.0 classifications, malignancy probability is higher for GGOs than solid nodules within the same category. A risk-based classification of GGOs would assign annual screening for GGOs 4 to 5 mm (0.4% malignancy risk); 6-month follow-up for GGOs 6 to 7 mm (1.1%), 8 to 14 mm (3.0%), and 15 to 19 mm (5.2%); and 3-month follow-up for greater than or equal to 20 mm (10.9%). This reclassification would have assigned similarly fatal cancers to 3-month follow-up (hazard ratio = 2.0 for lung-cancer death in GGOs versus solid-nodule cancers, 95% confidence interval: 0.4-8.7), but for 6-month follow-up, mortality was lower in GGO cancers (hazard ratio = 0.18, 95% confidence interval: 0.05-0.67).
CONCLUSIONS


If Lung-RADS categories for GGOs were based on malignancy probability, then 6- to 19-mm GGOs would receive 6-month follow-up and greater than or equal to 20-mm GGOs would receive 3-month follow-up. Such risk-based management for GGOs could improve the sensitivity of Lung-RADS, especially for large GGO cancers. However, small GGO cancers were less aggressive than their solid-nodule counterparts.",2019,"Such risk-based management for GGOs could improve the sensitivity of Lung-RADS, especially for large GGO cancers.",[],[],['lung-cancer mortality'],[],[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0381368,"Such risk-based management for GGOs could improve the sensitivity of Lung-RADS, especially for large GGO cancers.","[{'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Robbins', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. Electronic address: RobbinsH@iarc.fr.'}, {'ForeName': 'Hormuzd A', 'Initials': 'HA', 'LastName': 'Katki', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Li C', 'Initials': 'LC', 'LastName': 'Cheung', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Landy', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Berg', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.05.012']
3178,32061731,Efficacy and Safety of Intensive Blood Pressure Therapy Using Restricted Mean Survival Time-Insights from the SPRINT Trial.,,2020,,[],['Intensive Blood Pressure Therapy'],[],[],"[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0489886,,"[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Krishnaswami', 'Affiliation': 'Division of Cardiology, Kaiser Permanente San Jose Medical Center, San Jose, Calif; Department of Epidemiology and Biostatistics, University of California, San Francisco. Electronic address: ashok.krishnaswami@kp.org.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, and Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': 'Division of Cardiology, Washington University, St. Louis, Mo.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.050']
3179,31881622,Discussion: Evaluation of Hydrocodone/Acetaminophen for Pediatric Laceration Repair: A Randomized Trial.,,2020,,['Pediatric Laceration Repair'],['Hydrocodone/Acetaminophen'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",[],,0.0378106,,"[{'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Lalonde', 'Affiliation': 'St. John, New Brunswick, Canada From Dalhousie University.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006411']
3180,32058422,Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],"['Intraarticular Tranexamic Acid', 'Letter to the Editor']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.143475,,"[{'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Wu', 'Affiliation': 'X-D Wu, D. Wu, Y. Liu, Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. W. Huang, Department of Orthopaedic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001158']
3181,31883637,Oxytocin changes behavior and spatio-temporal brain dynamics underlying inter-group conflict in humans.,"Inter-group conflicts drive human discrimination, mass migration, and violence, but their psychobiological mechanisms remain largely unknown. Here, we investigated whether the neuropeptide oxytocin modulates behavior and spatio-temporal brain dynamics in naturalistic inter-group conflict. Eighty-six male members of natural rival social groups received either oxytocin or placebo intranasally. In a decision-making paradigm involving real monetary stakes, participants could sacrifice their own resources to modulate the monetary gains and losses of in- and out-group members. Oxytocin eliminated the reduction in out-group gains - particularly in individuals with low emotional empathy, whereas those given placebo exhibited this negative social behavior. Our spatio-temporal analysis of event-related potentials elicited by outcome valuation revealed that oxytocin replaced a neurophysiological process associated with the negative valuation of out-group gains via a process associated with positive valuation between 200-500ms after outcome presentation. Oxytocin thus seems to modulate inter-group behavior in humans via a specific alteration of valuation-related brain dynamics.",2020,"Oxytocin eliminated the reduction in out-group gains - particularly in individuals with low emotional empathy, whereas those given placebo exhibited this negative social behavior.","['humans', 'Eighty-six male members of natural rival social groups']","['Oxytocin', 'neuropeptide oxytocin', 'oxytocin or placebo', 'oxytocin', 'placebo']",['negative social behavior'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0687744', 'cui_str': 'Social group (observable entity)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0037397', 'cui_str': 'Social Behavior'}]",86.0,0.0806645,"Oxytocin eliminated the reduction in out-group gains - particularly in individuals with low emotional empathy, whereas those given placebo exhibited this negative social behavior.","[{'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, D-79104 Freiburg, Germany; Freiburg Brain Imaging Center, University Medical Center, University of Freiburg, D-79106 Freiburg, Germany. Electronic address: schiller@psychologie.uni-freiburg.de.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Domes', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, D-79104 Freiburg, Germany; Freiburg Brain Imaging Center, University Medical Center, University of Freiburg, D-79106 Freiburg, Germany; Department of Biological and Clinical Psychology, University of Trier, D-54290 Trier, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, D-79104 Freiburg, Germany; Freiburg Brain Imaging Center, University Medical Center, University of Freiburg, D-79106 Freiburg, Germany. Electronic address: heinrichs@psychologie.uni-freiburg.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.12.109']
3182,31910861,Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed.,"The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.",2020,"At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial?",[],[],[],[],[],[],,0.103623,"At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial?","[{'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK. streweek@mac.com.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bevan', 'Affiliation': 'National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'MRC North West Hub for Trials Methodology Research, Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Briel', 'Affiliation': 'Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'Christie', 'Affiliation': 'GSK Medicines Research Centre, Stevenage, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Collett', 'Affiliation': 'Health Research Authority, London, UK.'}, {'ForeName': 'Seonaidh', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'HRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'El Feky', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Galvin', 'Affiliation': 'HRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Gardner', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gillies', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': 'Division of Acute Care Surgery, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Adwoa', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ramsay', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Restrup', 'Affiliation': 'Public and patient representative, Aberdeen, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, St Andrews University, St Andrews, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Tremain', 'Affiliation': 'National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'von Elm', 'Affiliation': 'Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Westmore', 'Affiliation': 'National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.'}, {'ForeName': 'Hywel', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': ""Centre of Evidence-Based Dermatology, Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'MRC North West Hub for Trials Methodology Research, Department of Biostatistics University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.""}]",Trials,['10.1186/s13063-019-3980-5']
3183,31651697,"The Use of Botulinum Toxin Type A in the Healing of Thyroidectomy Wounds: A Randomized, Prospective, Placebo-Controlled Study.",,2020,,[],"['Placebo', 'Botulinum Toxin Type A']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]",[],,0.0228706,,"[{'ForeName': 'Panxi', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': ""Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Zuoliang', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006352']
3184,32015285,Reducing Patient Burden and Improving Data Quality With the New Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire.,"BACKGROUND


The Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire was developed in response to the need for a new, fast, and comprehensive tool for evaluating quality of life in patients who have colorectal cancer. Available surveys such as the SF-12, SF-36, Functional Assessment of Cancer Therapy-Colorectal, and European Organization for Research and Treatment of Cancer are either too general to be informative or too lengthy to complete.
OBJECTIVE


The aim was to validate the Cleveland Clinic Foundation Colorectal Quality of Life Questionnaire.
DESIGN


Data were obtained as part of a prospective randomized controlled trial.
SETTINGS


This was a worldwide multicenter study with 2 domestic and 5 international locations.
PATIENTS


This study randomly assigned 190 patients between the ages of 18 and 80 undergoing surgery for low rectal cancer. Of those randomly assigned, 142 with partially complete surveys were analyzed for selection bias and acceptability, and 95 with complete surveys were analyzed for survey validity.
INTERVENTIONS


Patients received either a J-pouch, side-to-end anastomosis, or straight anastomosis.
MAIN OUTCOME MEASURE


The study evaluated survey validity measures such as standardized Cronbach α for internal consistency and Spearman correlation coefficients for construct validity, convergent validity, and responsiveness. Univariate analyses were used to assess discriminative validity.
RESULTS


Sufficient acceptability, construct, and convergent validity and responsiveness were achieved. All scores showed great internal consistency (Cronbach α >0.8). Superior discriminative ability was demonstrated by significant differences (p < 0.05) in 2 of 7 scores between neoadjuvant treatment groups, and in 6 of 7 scores between complication groups, none of which were detected by the SF-12 or Functional Assessment of Cancer Therapy-Colorectal surveys.
LIMITATIONS


Limitations included a small sample size, cultural differences, and failure to assess test-retest ability of the questionnaire.
CONCLUSIONS


The Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire is an efficient and reliable quality-of-life measure that better incorporates factors specific to colorectal cancer surgery. See Video Abstract at http://links.lww.com/DCR/B155. REDUCIENDO LA CARGA AL PACIENTE Y MEJORANDO LA CALIDAD DE DATOS CON EL NUEVO CUESTIONARIO DE CALIDAD DE VIDA EN CÁNCER COLORRECTAL DE CLEVELAND CLINIC (CCF-CAQL): El cuestionario de calidad de vida en cáncer colorrectal de Cleveland Clinic se desarrolló en respuesta a la necesidad de una herramienta nueva, rápida e integral para evaluar la calidad de vida en pacientes con cáncer colorrectal. Los cuestionarios disponibles como SF-12, SF-36, FACT-C y EORTC son demasiado generales para ser informativas o demasiado largas para completar.El objetivo fue validar el cuestionario de calidad de vida colorrectal de la Cleveland Clinic Foundation.Los datos se obtuvieron como parte de un ensayo prospectivo aleatorizado y controlado.Este fue un estudio multicéntrico mundial con dos sedes nacionales y cinco internacionales.Este estudio aleatorizó a 190 pacientes entre las edades de 18 y 80 sometidos a cirugía por cáncer rectal bajo. De aquellos aleatorizados, 142 con encuestas parcialmente completas se analizaron para determinar el sesgo de selección y la aceptabilidad, y 95 con encuestas completas se analizaron para determinar la validez de la encuesta.Los pacientes recibieron un reservorio en J, anastomosis latero-terminal o anastomosis termino-terminal.El estudio evaluó medidas de validez de la encuesta, como el Alfa de Cronbach estandarizado para la consistencia interna y los coeficientes de correlación de Spearman para la validez de construcción, la validez de convergencia y la capacidad de respuesta. Se utilizaron análisis univariados para evaluar la validez discriminativa.Se obtuvo suficiente aceptabilidad, construcción, validez de convergencia, y capacidad de respuesta. Todos los puntajes mostraron una gran consistencia interna (alfa de Cronbach > 0.8). Una capacidad discriminativa superior fue demostrada por diferencias significativas (p < 0.05) en dos de siete puntajes entre grupos de tratamiento neoadyuvante, y en seis de siete puntajes entre grupos de complicaciones, ninguno de los cuales fue detectado por SF-12 o FACT-C.Las limitaciones incluyeron un tamaño de muestra pequeño, diferencias culturales y la falta de evaluación de la confiabilidad test-retest del cuestionario.El Cuestionario de Calidad de Vida en Cáncer Colorrectal de Cleveland Clinic es una medida de calidad de vida eficiente y confiable que incorpora mejor factores específicos asociados a la cirugía de cáncer colorrectal. Consulte Video Resumen en http://links.lww.com/DCR/B155.",2020,"Superior discriminative ability was demonstrated by significant differences (p<0.05) in two of seven scores between neoadjuvant treatment groups, and in six of seven scores between complication groups -- none of which were detected by the SF-12 or FACT-C.
LIMITATIONS


Limitations included a small sample size, cultural differences, and failure to assess test-retest ability of the questionnaire.
","['190 patients between the ages of 18 and 80 undergoing surgery for low rectal cancer', 'colorectal cancer patients']","['J-pouch, side to end anastomosis, or straight anastomosis']",['Reducing patient burden and improving data quality with the new Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire (CCF-CaQL'],"[{'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0086492', 'cui_str': 'J-Pouch'}, {'cui': 'C0392773', 'cui_str': 'Side-to-end anastomosis - action (qualifier value)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0454845', 'cui_str': 'Cleveland (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",190.0,,"Superior discriminative ability was demonstrated by significant differences (p<0.05) in two of seven scores between neoadjuvant treatment groups, and in six of seven scores between complication groups -- none of which were detected by the SF-12 or FACT-C.
LIMITATIONS


Limitations included a small sample size, cultural differences, and failure to assess test-retest ability of the questionnaire.
","[{'ForeName': 'Massarat', 'Initials': 'M', 'LastName': 'Zutshi', 'Affiliation': 'Department of Colorectal Surgery, Cleveland Clinic Foundation Cleveland, Ohio.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Aiello', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Fuerst', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Adipositasmedizin Caritas-KH St. Josef, Regensburg, Germany.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Golcher', 'Affiliation': 'Department of Surgery, Friedrich-Alexander-Universität, Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Parc', 'Affiliation': 'Department of Digestive Surgery, Hospital Saint Antoine, Sorbonne Université, Paris, France.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Galandiuk', 'Affiliation': 'Departmentof Colorectal Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Hull', 'Affiliation': 'Department of Colorectal Surgery, Cleveland Clinic Foundation Cleveland, Ohio.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Ruppert', 'Affiliation': 'Department of Colorectal Surgery, Krankenhaus München Neuperlach, Munich, Germany.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001575']
3185,31740427,An efficient Bayesian platform trial design for borrowing adaptively from historical control data in lymphoma.,"To reduce a clinical trial's cost and ethical risk to its enrollees, some oncology trial designers have suggested borrowing information from similar but already completed trials to reduce the number of patients needed for the current study. Motivated by competing drug therapies for lymphoma, we propose a Bayesian adaptive ""platform"" trial design that uses commensurate prior methods at interim analyses to borrow adaptively from the control group of an earlier-starting trial. The design adjusts the trial's randomization ratio in favor of the novel treatment when the interim posterior indicates commensurability of the two control groups. In this setting, our design can supplement a control arm with historical data, and randomize more new patients to the novel treatments. This design is both ethical and economical, since it shortens the process of introducing new treatments into the market, and any additional costs introduced by this design will be compensated by the savings in control arm sizes. Our approach performs well via simulation across settings with varying degrees of commensurability and true treatment effects, and compares favorably to an adaptive ""all-or-nothing"" approach in which the decision to pool or discard historical controls is based on a simple ad-hoc frequentist test at interim analysis. We also consider a three drug extension where a new imaginary intervention joins the platform, and show again that our procedure performs well via simulation.",2020,"Our approach performs well via simulation across settings with varying degrees of commensurability and true treatment effects, and compares favorably to an adaptive ""all-or-nothing"" approach in which the decision to pool or discard historical controls is based on a simple ad-hoc frequentist test at interim analysis.",['lymphoma'],[],[],"[{'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]",[],[],,0.0738965,"Our approach performs well via simulation across settings with varying degrees of commensurability and true treatment effects, and compares favorably to an adaptive ""all-or-nothing"" approach in which the decision to pool or discard historical controls is based on a simple ad-hoc frequentist test at interim analysis.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Normington', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, USA. Electronic address: jpnormington@gmail.com.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Genentech, Dept. of Biostatistics, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mattiello', 'Affiliation': 'F. Hoffmann-La Roche, Dept. of Biostatistics, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'Somnath', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Flatiron Health, New York, NY, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Carlin', 'Affiliation': 'Counterpoint Statistical Consulting, Minneapolis, MN, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105890']
3186,31838257,Mobility and outcomes for validated evidence - Incentive trial (MOVE IT): Randomized clinical trial study protocol.,,2020,,[],['validated evidence - Incentive trial (MOVE IT'],[],[],"[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}]",[],,0.241525,,"[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Greysen', 'Affiliation': 'Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA. Electronic address: hgreysen@upenn.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reale', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Mercede', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA; University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA; University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA; University of Pennsylvania, Wharton School, Philadelphia, PA, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Small', 'Affiliation': 'University of Pennsylvania, Wharton School, Philadelphia, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Snider', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rareshide', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'S Ryan', 'Initials': 'SR', 'LastName': 'Greysen', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105911']
3187,31850505,The DAPA-HF trial marks the beginning of a new era in the treatment of heart failure with reduced ejection fraction.,,2020,,[],[],[],[],[],[],,0.0234588,,"[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, ON M5B 1W8, Canada.""}]",Cardiovascular research,['10.1093/cvr/cvz328']
3188,32193277,Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes.,"INTRODUCTION


Trachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.
METHODS AND ANALYSIS


Maximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.
ETHICS AND DISSEMINATION


The University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03100747.",2020,Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes.,[],"['Trachomatous trichiasis (TT', 'Maximising trichiasis surgery Success (MTSS', 'BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height']","['risk of postoperative TT (PTT', 'incident PTT within 1 year following surgery', 'bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR']",[],"[{'cui': 'C0221259', 'cui_str': 'Trichiasis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]",,0.359538,Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes.,"[{'ForeName': 'Belay', 'Initials': 'B', 'LastName': 'Bayissasse', 'Affiliation': 'Orbis International Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Shannath L', 'Initials': 'SL', 'LastName': 'Merbs', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Department of Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Keil', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Sisay', 'Affiliation': 'Orbis International Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Singer', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Gower', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA egower@unc.edu.'}]",BMJ open,['10.1136/bmjopen-2019-036327']
3189,32118608,CORR Insights®: Can an Integrative Care Approach Improve Physical Function Trajectories after Orthopaedic Trauma? A Randomized Controlled Trial.,,2020,,[],[],['Physical Function Trajectories'],[],[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.12488,,"[{'ForeName': 'Julius A', 'Initials': 'JA', 'LastName': 'Bishop', 'Affiliation': 'J. A. Bishop, Associate Professor, Stanford University Medical Center, Department of Orthopaedic Surgery, Redwood City, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001195']
3190,32167717,Editorial Comment: A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.,,2020,,[],['Editorial Comment'],[],[],"[{'cui': 'C0282411', 'cui_str': 'Commentary'}]",[],,0.0435491,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.03.06']
3191,32250135,Does spending money on others promote happiness?: A registered replication report.,"Research indicates that spending money on others- prosocial spending -leads to greater happiness than spending money on oneself (e.g., Dunn, Aknin, & Norton, 2008, 2014). These findings have received widespread attention because they offer insight into why people engage in costly prosocial behavior, and what constitutes happier spending more broadly. However, most studies on prosocial spending (like most research on the emotional benefits of generosity) utilized small sample sizes ( n  < 100/cell). In light of new, improved standards for evidentiary value, we conducted high-powered registered replications of the central paradigms used in prosocial spending research. In Experiment 1, 712 students were randomly assigned to make a purchase for themselves or a stranger in need and then reported their happiness. As predicted, participants assigned to engage in prosocial (vs. personal) spending reported greater momentary happiness. In Experiment 2, 1950 adults recalled a time they spent money on themselves or someone else and then reported their current happiness; contrary to predictions, participants in the prosocial spending condition did not report greater happiness than those in the personal spending condition. Because low levels of task engagement may have produced these null results, we conducted a replication with minor changes designed to increase engagement; in this Experiment 3 ( N  = 5,199), participants who recalled a prosocial (vs. personal) spending memory reported greater happiness but differences were small. Taken together, these studies support the hypothesis that spending money on others does promote happiness, but demonstrate that the magnitude of the effect depends on several methodological features. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"As predicted, participants assigned to engage in prosocial (vs. personal) spending reported greater momentary happiness.","['712 students', '1950 adults recalled a']",[],"['time they spent money on themselves or someone else', 'momentary happiness']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",,0.0370996,"As predicted, participants assigned to engage in prosocial (vs. personal) spending reported greater momentary happiness.","[{'ForeName': 'Lara B', 'Initials': 'LB', 'LastName': 'Aknin', 'Affiliation': 'Department of Psychology, Simon Fraser University.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Dunn', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Proulx', 'Affiliation': 'Department of Psychology, Simon Fraser University.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lok', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Norton', 'Affiliation': 'Marketing Unit, Harvard Business School.'}]",Journal of personality and social psychology,['10.1037/pspa0000191']
3192,17523483,[Microbiologicaland immunological criteria for estimation of ureaplasmosis treatment efficacy in women].,"The role of surface and parietal vaginal microbiocenosis and immunoglobulins in development of infectious process, in prediction of resistance of causative microorganism to antibiotics and treatment efficacy was demonstrated on group of women with ureaplasmosis. Evaluation of anaerobic part of vaginal microbiota contemporary with its aerobic part reliably increased informative value of microbiological test in women with urogenital diseases. There are reasons to include interferon preparations into the complex therapy of ureaplasmosis.",2007,Evaluation of anaerobic part of vaginal microbiota contemporary with its aerobic part reliably increased informative value of microbiological test in women with urogenital diseases.,"['women', 'group of women with ureaplasmosis', 'women with urogenital diseases']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080276', 'cui_str': 'Disorder of the genitourinary system'}]",[],[],,0.0210872,Evaluation of anaerobic part of vaginal microbiota contemporary with its aerobic part reliably increased informative value of microbiological test in women with urogenital diseases.,"[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Voropaeva', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': ""Afanas'ev"", 'Affiliation': ''}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Aleshkin', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': ""Vorob'ev"", 'Affiliation': ''}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Kudriavtseva', 'Affiliation': ''}, {'ForeName': 'Iu A', 'Initials': 'IuA', 'LastName': 'Nesvizhskiĭ', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': ""Afanas'ev"", 'Affiliation': ''}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Matveevskaia', 'Affiliation': ''}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Panurina', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
3193,32248849,Longitudinal associations between ultra-processed foods and blood lipids in childhood.,"Emerging evidence suggests that the consumption of ultra-processed foods (UPF) plays a role in the development of chronic diseases, but evidence of their influence in children is limited. Our objective was to study longitudinal trends of UPF intake and determine their impact on blood lipids in young children. The present study was a follow-up of a randomised field trial of children (n 308) from Porto Alegre, Brazil. Dietary intake was collected using two 24-h recalls at 3 and 6 years of age, and consumption of UPF was classified according to the NOVA system, a food classification based on the extent and purpose of industrial food processing. At age 6 years, blood tests were performed to measure lipid profile. Contribution of UPF to total energy intake increased by 10 % during the follow-up period, from 43·4 % at 3 years to 47·7 % at 6 years of age. Linear regression models showed that children in the highest tertile of UPF consumption at age 3 years had higher levels of total cholesterol (TC; β 0·22 mmol/l; 95 % CI 0·04, 0·39) and TAG at age 6 years (β 0·11 mmol/l, 95 % CI 0·01, 0·20) compared with those in the lowest tertile. A positive dose-response was observed for an absolute increment of 10 % of UPF on TC (β 0·07 mmol/l, 95 % CI 0·00, 0·14) and TAG (β 0·04 mmol/l, 95 % CI 0·01, 0·07). Based on our data, consumption of UPF increased significantly over time and was associated with higher blood lipid levels in children from a low-income community. Our findings highlight the need for effective strategies to minimise the consumption of UPF in early life.",2020,"Based on our data, consumption of UPF increased significantly over time and was associated with higher blood lipids levels in children from a low-income community.","['children (n=308) from Porto Alegre, Brazil', 'young children', 'childhood']",[],"['blood lipids', 'Dietary intake', 'blood lipids levels', 'total cholesterol', 'UPF consumption', 'total energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]",[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0461934,"Based on our data, consumption of UPF increased significantly over time and was associated with higher blood lipids levels in children from a low-income community.","[{'ForeName': 'Paula S', 'Initials': 'PS', 'LastName': 'Leffa', 'Affiliation': 'Graduate Program of Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hoffman', 'Affiliation': 'Department of Nutritional Sciences, New Jersey Institute for Food, Nutrition, and Health, Center for Childhood Nutrition Research, Rutgers, the State University of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Rauber', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Caroline N', 'Initials': 'CN', 'LastName': 'Sangalli', 'Affiliation': 'Graduate Program of Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Júlia L', 'Initials': 'JL', 'LastName': 'Valmórbida', 'Affiliation': 'Graduate Program in Pediatrics: Child and Adolescent Health Care, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Márcia R', 'Initials': 'MR', 'LastName': 'Vitolo', 'Affiliation': 'Graduate Program of Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114520001233']
3194,32198304,Mindfulness-based programme for residents: study protocol of a randomised controlled trial.,"INTRODUCTION


Residency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians' mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents' needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße.
METHODS AND ANALYSIS


This study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8 weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents' self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6 months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling.
ETHICS AND DISSEMINATION


The study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center 'SFB Muße 1015'. The results of this study will be published in scientific journals and disseminated through the study's website, and conferences.
TRIAL REGISTRATION NUMBER


DRKS00014015.",2020,The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents' self-care as well as on building empathic relationships.,[],"['control group will read text-based information about mindfulness', 'mindfulness-based intervention']",[],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",[],,0.0591679,The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents' self-care as well as on building empathic relationships.,"[{'ForeName': 'Vanessa Marie-Jane', 'Initials': 'VM', 'LastName': 'Aeschbach', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, Freiburg im Breisgau, Germany vanessa.aeschbach@uniklinik-freiburg.de.'}, {'ForeName': 'Johannes Caspar', 'Initials': 'JC', 'LastName': 'Fendel', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Anja Simone', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, Freiburg im Breisgau, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-035025']
3195,30142303,The Effect of CS Administration or an R-Optimized Alternative on Potential Projective Material in Rorschach Responses From Six Studies and a Meta-Analysis of Their Findings.,"The Rorschach Performance Assessment System (R-PAS; Meyer, Viglione, Mihura, Erard, & Erdberg, 2011) introduced R-optimized administration to reduce variability in the number of Responses (R). We provide new data from six studies of participants randomly assigned to receive a version of this method or Comprehensive System (CS; Exner, 2003) administration. We examine how administration methods affect 3 types of codes most likely to contain potential projective material and the frequency of these codes for the 1st, 2nd, 3rd, 4th, or last response to a card (R in Card). In a meta-analytic summary, we found 37% of responses have 1 type of code, 19% have 2 types, and 3% have all 3 types, with stable proportions across responses within cards. Importantly, administration method had no impact on potential projective variable means. Differential skew across samples made variability harder to interpret. Initial results suggesting differences in 3 of the 18 specific Type by R in Card pairs did not follow a coherent pattern and disappeared when using raw counts from all participants. Overall, data do not support concerns that R-optimized administration might alter potential projective processes, or make potentially ""signature"" last responses to the card any different in R-PAS than the CS.",2020,Initial results suggesting differences in 3 of the 18 specific Type by R in Card pairs did not follow a coherent pattern and disappeared when using raw counts from all participants.,[],['CS'],[],[],[],[],,0.109642,Initial results suggesting differences in 3 of the 18 specific Type by R in Card pairs did not follow a coherent pattern and disappeared when using raw counts from all participants.,"[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychology, University of Toledo.'}, {'ForeName': 'Abufazel', 'Initials': 'A', 'LastName': 'Hosseininasab', 'Affiliation': 'Department of Psychology, Tarbiat Modares University and University of Toledo.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Viglione', 'Affiliation': 'California School of Professional Psychology, Alliant International University.'}, {'ForeName': 'Joni L', 'Initials': 'JL', 'LastName': 'Mihura', 'Affiliation': 'Department of Psychology, University of Toledo.'}, {'ForeName': 'Ety', 'Initials': 'E', 'LastName': 'Berant', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliyya, Israel.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Resende', 'Affiliation': 'Department of Psychology, Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Reese', 'Affiliation': 'Private Practice, Columbus, OH.'}]",Journal of personality assessment,['10.1080/00223891.2018.1492926']
3196,31869338,Human gut microbiota is associated with HIV-reactive immunoglobulin at baseline and following HIV vaccination.,"Antibodies that recognize commensal microbial antigens may be cross reactive with a part of the human immunodeficiency virus (HIV) envelope glycoprotein gp41. To improve understanding of the role of the microbiota in modulating the immune response to HIV vaccines, we studied the associations of the gut microbiota composition of participants in the HIV Vaccine Trials Network 096 clinical trial with their HIV-specific immune responses in response to vaccination with a DNA-prime, pox virus boost strategy designed to recapitulate the only efficacious HIV-vaccine trial (RV144). We observed that both levels of IgG antibodies to gp41 at baseline and post-vaccination levels of IgG antibodies to the Con.6.gp120.B, ZM96.gp140 and gp70 B.CaseA V1-V2 antigens were associated with three co-occurring clusters of family level microbial taxa. One cluster contained several families positively associated with gp41-specific IgG and negatively associated with vaccine-matched gp120, gp140 and V1-V2-specific IgG responses. A second cluster contained families that negatively associated with gp41 and positively associated with gp120, gp140 and V1-V2-specific IgG responses. A third cluster contained microbial groups that did not correlate with any immune responses. Baseline and post-vaccination levels of gp41 IgG were not significantly correlated, suggesting that factors beyond the microbiome that contribute to immune response heterogeneity. Sequence variant richness was positively associated with gp41, p24, pg140 and V1-V2 specific IgG responses, gp41 and p24 IgA responses, and CD4+ T cell responses to HIV-1 proteins. Our findings provide preliminary evidence that the gut microbiota may be an important predictor of vaccine response.",2019,"Sequence variant richness was positively associated with gp41, p24, pg140 and V1-V2 specific IgG responses, gp41 and p24 IgA responses, and CD4+ T cell responses to HIV-1 proteins.",[],[],"['V1-V2 specific IgG responses, gp41 and p24 IgA responses, and CD4+ T cell responses', 'gp41-specific IgG', 'levels of IgG antibodies']",[],[],"[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0019692', 'cui_str': 'Envelope Protein gp41, HIV'}, {'cui': 'C0085219', 'cui_str': 'HIV p24 antigen'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.110346,"Sequence variant richness was positively associated with gp41, p24, pg140 and V1-V2 specific IgG responses, gp41 and p24 IgA responses, and CD4+ T cell responses to HIV-1 proteins.","[{'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Cram', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Karuna', 'Affiliation': 'HIV Vaccine Trials Network, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Service of Immunology and Allergy, and Swiss Vaccine Research Institute, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, United States of America.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Fredricks', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'HIV Vaccine Trials Network, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0225622']
3197,32268344,The role of dopamine in dynamic effort-reward integration.,"When deciding to act, the neurotransmitter dopamine is implicated in a valuation of prospective effort and reward. However, its role in dynamic effort-reward integration during action, a process central to everyday behaviour, remains unclear. In a placebo-controlled, within-subject, study, we probed the impact of increasing brain dopamine levels (150 mg of levodopa) and blocking dopamine receptors (1.5 mg of haloperidol) in the context of a novel dynamic effort task in healthy human subjects. We show that modulating homoeostatic dopamine balance distinctly alters implicit and explicit effort allocation as a function of instantaneous reward. Pharmacologically boosting dopamine enhanced motor vigour, reflected in an implicit increase in effort allocation for high rewards. Conversely, pharmacological blockade of dopamine attenuated sensitivity to differences in reward context, reflected in reduced strategic effort discounting. These findings implicate dopamine in an integration of momentary physical experience and instantaneous reward, suggesting a key role of dopamine in acting to maximise reward on the fly.",2020,"Pharmacologically boosting dopamine enhanced motor vigour, reflected in an implicit increase in effort allocation for high rewards.",['healthy human subjects'],"['dopamine', 'brain dopamine levels (150\u2009mg of levodopa) and blocking dopamine receptors (1.5\u2009mg of haloperidol']",[],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034798', 'cui_str': 'Dopamine receptor'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]",[],,0.0198057,"Pharmacologically boosting dopamine enhanced motor vigour, reflected in an implicit increase in effort allocation for high rewards.","[{'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Michely', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, WC1N 3BG, UK.'}, {'ForeName': 'Shivakumar', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'Cognitive Neuroscience, Institute of Neuroscience & Medicine (INM-3), Research Centre Juelich, 52425, Juelich, Germany.'}, {'ForeName': 'Tobias U', 'Initials': 'TU', 'LastName': 'Hauser', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, WC1N 3BG, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Delker', 'Affiliation': 'Medical Faculty, University of Cologne and Department of Neurology, University Hospital Cologne, 50937, Cologne, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Dolan', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, WC1N 3BG, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grefkes', 'Affiliation': 'Medical Faculty, University of Cologne and Department of Neurology, University Hospital Cologne, 50937, Cologne, Germany. christian.grefkes@uk-koeln.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0669-0']
3198,31828755,Flow-controlled ventilation improves gas exchange in lung-healthy patients- a randomized interventional cross-over study.,"BACKGROUND


Flow-controlled ventilation (FCV) is a new ventilation mode that provides constant inspiratory and expiratory flow. FCV was shown to improve gas exchange and lung recruitment in porcine models of healthy and injured ventilated lungs. The primary aim of our study was to verify the influences of FCV on gas exchange, respiratory mechanics and haemodynamic variables in mechanically ventilated lung-healthy patients.
METHODS


After obtaining ethical approval and informed consent, we measured arterial blood gases, respiratory and haemodynamic variables during volume-controlled ventilation (VCV) and FCV in 20 consecutive patients before they underwent abdominal surgery. After baseline (BL) ventilation, patients were randomly assigned to either BL-VCV-FCV or BL-FCV-VCV. Thereby, BL ventilation settings were kept, except for the ventilation mode-related differences (FCV is supposed to be used with an I:E ratio of 1:1).
RESULTS


Compared to BL and VCV, PaO 2  was higher [PaO 2  : FCV: 38.2 (7.1), BL ventilation: 35.0 (5.8), VCV: 35.2 (7.0) kPa, P < .001] and PaCO 2  lower [PaCO 2  : FCV: 4.8 (0.5), BL ventilation: 5.1 (0.5), VCV: 5.1 (0.5) kPa, P < .001] during FCV. With comparable plateau pressure [BL: 14.9 (1.9), VCV: 15.3 (1.6), FCV: 15.2 (1.5) cm H 2  O), P = .185], tracheal mean pressure was higher during FCV [BL: 10.2 (1.1), VCV: 10.4 (0.7), FCV: 11.5 (1.0) cm H 2  O, P < .001]. Haemodynamic variables did not differ between ventilation phases.
CONCLUSION


Flow-controlled ventilation improves oxygenation and carbon dioxide elimination within a short time, compared to VCV with identical tidal volume, inspiratory plateau pressure and end-expiratory pressure.",2020,", tracheal mean pressure was higher during FCV","['lung-healthy patients', '20 consecutive patients before they underwent abdominal surgery', 'mechanically ventilated lung-healthy patients']","['Flow-controlled ventilation (FCV', 'volume-controlled ventilation (VCV) and FCV', 'FCV', 'Flow-controlled ventilation', 'BL-VCV-FCV or BL-FCV-VCV']","['VCV with identical tidal volume, inspiratory plateau pressure and end-expiratory pressure', 'arterial blood gases, respiratory and haemodynamic variables', 'Haemodynamic variables', 'tracheal mean pressure', 'oxygenation and carbon dioxide elimination']","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C0015763', 'cui_str': 'Calicivirus, Feline'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}]","[{'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure (qualifier value)'}, {'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0445074', 'cui_str': 'Mean pressure (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",20.0,0.0670597,", tracheal mean pressure was higher during FCV","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Straka', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wirth', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13526']
3199,30629813,"Cost-Effectiveness of Combination Disease-Modifying Antirheumatic Drugs Versus Tumor Necrosis Factor Inhibitors in Active Rheumatoid Arthritis: A Pragmatic, Randomized, Multicenter Trial.","OBJECTIVE


To determine whether intensive combinations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDS) achieve similar clinical benefits more cheaply than high-cost biologics such as tumor necrosis factor inhibitors (TNFi) in patients with active rheumatoid arthritis (RA) whose illness has failed to respond to methotrexate and another DMARD.
METHODS


We used within-trial cost-effectiveness and cost-utility analyses from health and social care and 2 societal perspectives. Participants were recruited into an open-label, 12-month, pragmatic, randomized, multicenter, 2-arm, noninferiority trial in 24 rheumatology clinics in England and Wales. Costs were linked with the Health Assessment Questionnaire (HAQ; primary outcome) and quality-adjusted life years derived from 2 measures (Short-Form 36 health survey and EuroQol 5-domain 3-level instrument).
RESULTS


In total, 205 participants were recruited, 104 in the csDMARD arm and 101 in the TNFi arm. Participants in the csDMARD arm with poor response at 6 months were offered TNFi; 46 participants (44%) switched. Relevant cost and outcome data were available for 93% of participants at 6-month follow-up and for 91-92% of participants at 12-month follow-up. The csDMARD arm had significantly lower total costs from all perspectives (6-month health and social care adjusted mean difference -£3,615 [95% confidence interval (95% CI) -4,104, -3,182]; 12-month health and social care adjusted mean difference -£1,930 [95% CI -2,599, -1,301]). The HAQ score showed benefit to the csDMARD arm at 12 months (-0.16 [95% CI -0.32, -0.01]); other outcomes/follow-ups showed no differences.
CONCLUSION


Starting treatment with csDMARDs, rather than TNFi, achieves similar outcomes at significantly lower costs. Patients with active RA and who meet the National Institute for Health and Care Excellence criteria for expensive biologics can be treated with combinations of intensive csDMARDs in a cost-effective manner.",2020,The cDMARDs arm had significantly lower total costs from all perspectives (6 month H&SC adjusted mean difference -£3615 (95% confidence interval -£4104 to -£3182); 12 month H&SC adjusted mean difference -£1930,"['active rheumatoid arthritis', '24 rheumatology clinics in England', '205 participants were recruited, 104 in the cDMARDs arm, 101 in the TNFis arm', 'Patients with active rheumatoid arthritis and meeting NICE criteria', 'patients with active rheumatoid arthritis (RA) who have failed to respond to methotrexate and another DMARD']","['combination disease-modifying antirheumatics vs. tumour necrosis factor inhibitors', 'health and social care (H&SC', 'synthetic disease modifying drugs (cDMARDS']","['total costs', 'Heath Assessment Questionnaire (HAQ; primary outcome) and quality-adjusted life years (QALYs']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C3812871', 'cui_str': 'Rheumatology clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",205.0,0.223462,The cDMARDs arm had significantly lower total costs from all perspectives (6 month H&SC adjusted mean difference -£3615 (95% confidence interval -£4104 to -£3182); 12 month H&SC adjusted mean difference -£1930,"[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Anita Patel Health Economics Consulting, London, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Heslin', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Scott', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Stringer', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Birrell', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, and Newcastle University, Newcastle, UK.'}, {'ForeName': 'Fowzia', 'Initials': 'F', 'LastName': 'Ibrahim', 'Affiliation': ""King's College London, London, UK.""}]",Arthritis care & research,['10.1002/acr.23830']
3200,32123143,The Impact of a Chronic Total Coronary Occlusion on Outcomes of Patients With an Implantable Cardioverter Defibrillator: Insights From the EXPLORE Trial.,"A chronic total occlusion (CTO) may increase the risk of appropriate implantable cardioverter-defibrillator (ICD) therapy. Therefore, we evaluated all patients who received an ICD during 5-year follow-up in the EXPLORE trial. Of 22 ICD patients, twelve were randomized to CTO percutaneous coronary intervention (PCI) and 10 to no revascularizaton of the CTO. Appropriate ICD therapy occurred in 1 patient in the CTO-PCI group. Compared with the 280 non-ICD patients in the EXPLORE trial, the 22 ICD patients had higher risk of adverse cardiac events (32% vs 10%; P<.01) and death (18% vs 6%; P=.02). These results suggest that ICD patients with CTO are at risk of poor outcomes; however, their benefit from ICD implantation is questionable.",2020,"Compared with the 280 non-ICD patients in the EXPLORE trial, the 22 ICD patients had higher risk of adverse cardiac events (32% vs 10%; P<.01) and death (18% vs 6%; P=.02).","['22 ICD patients', 'Patients With an Implantable Cardioverter Defibrillator']","['Chronic Total Coronary Occlusion', 'CTO percutaneous coronary intervention (PCI) and 10 to no revascularizaton of the CTO']","['death', 'higher risk of adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0151814', 'cui_str': 'Coronary Occlusion'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",280.0,0.0421384,"Compared with the 280 non-ICD patients in the EXPLORE trial, the 22 ICD patients had higher risk of adverse cardiac events (32% vs 10%; P<.01) and death (18% vs 6%; P=.02).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'van Veelen', 'Affiliation': ''}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': ''}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': ''}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Amsterdam UMC, AMC Heart Center, Department of Cardiology, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. j.p.henriques@amc.uva.nl.'}]",The Journal of invasive cardiology,[]
3201,31644357,"Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer.","PURPOSE


We previously reported the safety and immunologic effects of a DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP) in patients with recurrent, nonmetastatic prostate cancer. The current trial evaluated the effects of this vaccine on metastatic progression.
PATIENTS AND METHODS


Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months were randomly assigned to treatment with either pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF alone six times at 14-day intervals and then quarterly for 2 years. The primary end point was 2-year metastasis-free survival (MFS). Secondary and exploratory end points were median MFS, changes in PSA DT, immunologic effects, and changes in quantitative  18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging.
RESULTS


Two-year MFS was not different between study arms (41.8% vaccine  v  42.3%;  P  = .97). Changes in PSA DT and median MFS were not different between study arms (18.9  v  18.3 months; hazard ratio [HR], 1.6;  P  = .13). Preplanned subset analysis identified longer MFS in vaccine-treated patients with rapid (< 3 months) pretreatment PSA DT (12.0  v  6.1 months; n = 21; HR, 4.4;  P  = .03). PAP-specific T cells were detected in both cohorts, including multifunctional PAP-specific T-helper 1-biased T cells. Changes in total activity (total standardized uptake value) on  18 F-NaF PET/CT from months 3 to 6 increased 50% in patients treated with GM-CSF alone and decreased 23% in patients treated with pTVG-HP (n = 31;  P  = .07).
CONCLUSION


pTVG-HP treatment did not demonstrate an overall increase in 2-year MFS in patients with castration-sensitive prostate cancer, with the possible exception of a subgroup with rapidly progressive disease. Prespecified  18 F-NaF PET/CT imaging conducted in a subset of patients suggests that vaccination had detectable effects on micrometastatic bone disease. Additional trials using pTVG-HP in combination with PD-1 blockade are under way.",2019,"Changes in PSA DT and median MFS were not different between study arms (18.9  v  18.3 months; hazard ratio [HR], 1.6;  P  = .13).","['patients with recurrent, nonmetastatic prostate cancer', 'patients with castration-sensitive prostate cancer', 'Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months', 'Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer']","['GM-CSF', 'pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF', 'DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP', 'DNA', 'Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816', 'vaccine', 'pTVG-HP treatment', 'pTVG-HP']","['PSA DT and median MFS', 'total activity (total standardized uptake value', 'micrometastatic bone disease', 'PAP-specific T cells', 'median MFS, changes in PSA DT, immunologic effects, and changes in quantitative  18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging', '2-year metastasis-free survival (MFS', '2-year MFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}, {'cui': 'C0523444', 'cui_str': 'Prostatic acid phosphatase measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",99.0,0.082602,"Changes in PSA DT and median MFS were not different between study arms (18.9  v  18.3 months; hazard ratio [HR], 1.6;  P  = .13).","[{'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'McNeel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Eickhoff', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Johnson', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Roth', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Perk', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wargowski', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeraj', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University of Wisconsin, Madison, WI.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01701']
3202,32019814,"Vitamin B 12 , Folate, and Cognition in 6- to 9-Year-Olds: A Randomized Controlled Trial.","BACKGROUND AND OBJECTIVES


Vitamin B 12  and folate are important for normal brain development. Our objective for this study was to measure the effects of 6-month supplementation of vitamin B 12  and/or folic acid in early childhood on cognition when the children were 6 to 9 years old.
METHODS


The study is a follow-up of a factorial randomized, double-blind, placebo-controlled trial in 1000 North Indian children. Children 6 to 30 months of age were randomly assigned to receive a placebo or 1.8 µg of vitamin B 12 , 150 mg of folic acid, or both daily for 6 months. After 6 years, we re-enrolled 791 of these children for cognitive assessments. We compared the scores of the main outcomes (the Wechsler Intelligence Scale for Children, Fourth Edition [India], the Crichton Verbal Scale, and subtests of the NEPSY-II) between the study groups. We also measured the associations between markers of the B vitamins (plasma cobalamin, folate, and total homocysteine concentrations) in early childhood and the cognitive outcomes.
RESULTS


There were no differences between the intervention groups and the placebo group on the cognitive outcomes. Plasma cobalamin, folate, and total homocysteine concentrations in early childhood were associated with the cognitive outcomes at follow-up in the unadjusted models. These associations disappeared in models adjusted for relevant confounders.
CONCLUSIONS


Our findings, from both an observational and a randomized design suggest that vitamin B 12  and folate in children 6 to 36 months have limited public health relevance for long-term cognition.",2020,"Plasma cobalamin, folate, and total homocysteine concentrations in early childhood were associated with the cognitive outcomes at follow-up in the unadjusted models.","['early childhood on cognition when the children were 6 to 9 years old', 'After 6 years, we re-enrolled 791 of these children for cognitive assessments', 'Children 6 to 30 months of age', '1000 North Indian children']","['vitamin', 'vitamin B 12  and/or folic acid', 'placebo or 1.8 µg of vitamin B 12 , 150 mg of folic acid', 'placebo']","['B vitamins (plasma cobalamin, folate, and total homocysteine concentrations', 'Plasma cobalamin, folate, and total homocysteine concentrations', 'cognitive outcomes', 'Vitamin B 12 , Folate, and Cognition', 'Wechsler Intelligence Scale for Children, Fourth Edition [India], the Crichton Verbal Scale, and subtests of the NEPSY-II']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444858', 'cui_str': 'AM 6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086024', 'cui_str': 'Cobalamins'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0204457', 'cui_str': 'WISC-V'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}]",1000.0,0.381983,"Plasma cobalamin, folate, and total homocysteine concentrations in early childhood were associated with the cognitive outcomes at follow-up in the unadjusted models.","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare West, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India; sunita.taneja@sas.org.in.'}, {'ForeName': 'Ravi P', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial Science, Faculty of Psychology, University of Bergen, Bergen, Norway; and.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}]",Pediatrics,['10.1542/peds.2019-2316']
3203,32102056,Heat Acclimation with Controlled Heart Rate: Influence of Hydration Status.,"PURPOSE


This study aimed to characterize the adaptive responses to heat acclimation (HA) with controlled heart rate (HR) and determine whether hydration strategy alters adaptations. The influence of HA on maximal oxygen uptake (V˙O2max) in cool conditions and self-paced exercise in the heat was also determined.
METHODS


Eight men (V˙O2max, 55 ± 7 mL·kg·min) completed two 10-d interventions in a counterbalanced crossover design. Fluid intakes differed between interventions to either maintain euhydration (HA-EUH) or elicit similar daily body mass deficits (2.85% ± 0.26%; HA-DEH). HA consisted of 90 min of cycling in 40°C and 40% relative humidity. Initial workload (172 ± 22 W) was adjusted over the last 75 min to maintain exercising HR equivalent to 65% V˙O2max. A V˙O2max test in cool conditions and 30-min time trial in hot-humid conditions were completed before and after HA.
RESULTS


HR at the end of the initial 15 min workload was 10 ± 5 bpm lower on day 10 in both interventions (P < 0.001). The workload necessary to maintain exercising HR (145 ± 7 bpm) increased throughout HA-EUH (25 ± 10 W, P = 0.001) and HA-DEH (16 ± 18 W, P = 0.02). There was a main effect of HA on sweat rate (P = 0.014), which tended to increase with HA-EUH (0.19 ± 0.18 L·h, P = 0.06), but not HA-DEH (P = 0.12). Skin temperature decreased during HA-EUH (0.6°C ± 0.5°C, P = 0.03), but not HA-DEH (P = 0.30). There was a main effect of HA on V˙O2max (~3 mL·kg·min, P = 0.02); however, neither intervention independently increased V˙O2max (both, P = 0.08). Time-trial performance increased after HA-EUH (19 ± 16 W, P = 0.02), but not HA-DEH (P = 0.21).
CONCLUSIONS


Controlled HR exercise in the heat induces several HA adaptations, which may be optimized by maintaining euhydration. HA-EUH also improves self-paced exercise performance in the heat. However, HA does not seem to significantly increase V˙O2max in cool conditions.",2020,"Time-trial performance increased following HA-EUH (19±16 W, P=0.02), but not HA-DEH (P=0.21).
",['Eight males (V[Combining'],"['heat acclimation (HA) with controlled heart rate (HR', 'Dot Above]O2max ', 'V[Combining', 'maintain euhydration (HA-EUH']","['Time-trial performance', 'V[Combining', 'Fluid intakes', 'Skin temperature', 'self-paced exercise performance', 'HA-EUH', 'sweat rate']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}]",,0.0266036,"Time-trial performance increased following HA-EUH (19±16 W, P=0.02), but not HA-DEH (P=0.21).
","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Travers', 'Affiliation': 'Athlete Health and Performance Research Centre, Aspetar Orthopedic and Sports Medicine Hospital, Doha, QATAR.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nichols', 'Affiliation': 'Sport Development Centre, Loughborough University, Loughborough, UNITED KINGDOM.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Riding', 'Affiliation': 'Athlete Health and Performance Research Centre, Aspetar Orthopedic and Sports Medicine Hospital, Doha, QATAR.'}, {'ForeName': 'JosÉ', 'Initials': 'J', 'LastName': 'GonzÁlez-Alonso', 'Affiliation': 'Centre for Sports Medicine and Human Performance, Brunel University London, UNITED KINGDOM.'}, {'ForeName': 'Julien D', 'Initials': 'JD', 'LastName': 'PÉriard', 'Affiliation': 'Athlete Health and Performance Research Centre, Aspetar Orthopedic and Sports Medicine Hospital, Doha, QATAR.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002320']
3204,31927026,Effect of simethicone on reducing operative difficulty associated with bowel interference during minilaparotomy for modified Pomeroy salpingectomy: A randomized controlled trial .,"OBJECTIVE


To examine the effect of simethicone on reducing operative difficulty associated with bowel interference during minilaparotomy for postpartum modified Pomeroy partial salpingectomy.
STUDY DESIGN


We enrolled 20-45-year-old women planning the procedure from March 2018 to February 2019. We randomized participants to chew simethicone 160 mg with water 50 mL 2-8 h before surgery or no treatment. The participants were not blinded; however, surgeons, care providers, and outcome assessors were blinded to the study allocation. We measured surgeon-rated operative difficulty using a 10-cm visual analog scale that represented the difficulty perceived to be resulting from bowel interference. Secondary outcomes included operative time and intraoperative and postoperative complications.
RESULTS


We enrolled 60 women in each group; baseline characteristics and procedural profiles were comparable. Women in the intervention group used simethicone a median of 157 min (interquartile range 127-192) before the procedure. Surgeons rated the procedure difficulty score as 4.8 in the simethicone group and 4.5 in the control group (p = 0.57). Operative time in the two groups were 26 and 24 min, respectively (p = 0.14). We found no difference in intraoperative adverse events including blood loss and mesosalpinx tear, postoperative morbidities, hospital stay, and patient-rated satisfaction scores.
CONCLUSION


Preprocedural simethicone has no demonstrable benefit in reducing operative difficulty caused by bowel interference during minilaparotomy for postpartum tubal sterilization.
IMPLICATIONS


Preprocedural simethicone as given in this study did not result in reduced bowel interference and improved procedure difficulty. Further research examining simethicone in this setting would not be worthwhile as clinically meaningful benefit is unlikely.",2020,"We found no difference in intraoperative adverse events including blood loss and mesosalpinx tear, postoperative morbidities, hospital stay, and patient-rated satisfaction scores.
",['enrolled 20-45-year-old women planning the procedure from March 2018 to February 2019'],"['simethicone 160 mg with water 50', 'simethicone']","['operative time and intraoperative and postoperative complications', 'Operative time', 'intraoperative adverse events including blood loss and mesosalpinx tear, postoperative morbidities, hospital stay, and patient-rated satisfaction scores']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0230312', 'cui_str': 'Structure of mesosalpinx'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.244458,"We found no difference in intraoperative adverse events including blood loss and mesosalpinx tear, postoperative morbidities, hospital stay, and patient-rated satisfaction scores.
","[{'ForeName': 'Krittaya', 'Initials': 'K', 'LastName': 'Phirom', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Kittipat', 'Initials': 'K', 'LastName': 'Charoenkwan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand. Electronic address: kittipat.c@cmu.ac.th.'}]",Contraception,['10.1016/j.contraception.2019.12.002']
3205,31401679,"TMAO, creatine and 1-methylhistidine in serum and urine are potential biomarkers of cod and salmon intake: a randomised clinical trial in adults with overweight or obesity.","PURPOSE


To identify biomarkers to assess participants' compliance in an intervention study with high intake of cod or salmon, compared to a fish-free diet.
METHODS


In this randomised clinical trial, 62 healthy overweight/obese participants consumed 750 g/week of either cod (N = 21) or salmon (N = 22) across 5 weekly dinners, or were instructed to continue their normal eating habits but avoid fish intake (Control group, N = 19) for 8 weeks.
RESULTS


After cod intake, serum concentrations of trimethylamine N-oxide (TMAO, p = 0.0043), creatine (p = 0.024) and 1-methylhistidine (1-MeHis, p = 0.014), and urine concentrations (relative to creatinine) of TMAO (p = 2.8 × 10 -5 ), creatine (p = 8.3 × 10 -4 ) and 1-MeHis (p = 0.016) were increased when compared to Control group. After salmon intake, serum concentrations of 1-MeHis (p = 2.0 × 10 -6 ) and creatine (p = 6.1 × 10 -4 ), and urine concentrations (relative to creatinine) of 1-MeHis (p = 4.2 × 10 -6 ) and creatine (p = 4.0 × 10 -5 ) were increased when compared to Control group. Serum and urine concentrations of TMAO were more increased following cod intake compared to salmon intake (p = 0.028 and 2.9 × 10 -4 , respectively), and serum and urine 1-MeHis concentrations were more increased after salmon intake compared to cod intake (p = 8.7 × 10 -5  and 1.2 × 10 -4 , respectively). Cod and salmon intake did not affect serum and urine concentrations of 3-methylhistidine, and only marginally affected concentrations of free amino acids and amino acid metabolites.
CONCLUSION


TMAO measured in serum or urine is a potential biomarker of cod intake, and 1-MeHis measured in serum or urine is a potential biomarker of salmon intake.",2020,"After cod intake, serum concentrations of trimethylamine N-oxide (TMAO, p = 0.0043), creatine (p = 0.024) and 1-methylhistidine (1-MeHis, p = 0.014), and urine concentrations (relative to creatinine) of TMAO (p = 2.8 × 10 -5 ), creatine (p = 8.3 × 10 -4 ) and 1-MeHis (p = 0.016) were increased when compared to Control group.","[""participants' compliance in an intervention study with high intake of cod or salmon, compared to a fish-free diet"", '62 healthy overweight/obese participants consumed 750\xa0g/week of either cod (N\u2009=\u200921) or', 'adults with overweight or obesity']","['TMAO, creatine and 1-methylhistidine', 'salmon (N\u2009=\u200922) across 5 weekly dinners, or were instructed to continue their normal eating habits but avoid fish intake (Control group, N\u2009=\u200919) for 8\xa0weeks']","['serum and urine 1-MeHis concentrations', 'Serum and urine concentrations of TMAO', 'urine concentrations (relative to creatinine) of 1-MeHis', 'serum and urine concentrations of 3-methylhistidine', '1-MeHis', 'serum concentrations of trimethylamine N-oxide', 'serum concentrations of 1-MeHis', 'urine concentrations (relative to creatinine) of TMAO']","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0044470', 'cui_str': '1-methylhistidine'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0047600', 'cui_str': 'N(tau)-methylhistidine'}]",62.0,0.0595496,"After cod intake, serum concentrations of trimethylamine N-oxide (TMAO, p = 0.0043), creatine (p = 0.024) and 1-methylhistidine (1-MeHis, p = 0.014), and urine concentrations (relative to creatinine) of TMAO (p = 2.8 × 10 -5 ), creatine (p = 8.3 × 10 -4 ) and 1-MeHis (p = 0.016) were increased when compared to Control group.","[{'ForeName': 'Ingrid V', 'Initials': 'IV', 'LastName': 'Hagen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Helland', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bratlie', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Midttun', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sveier', 'Affiliation': 'Lerøy Seafood Group ASA, PO Box 7600, 5020, Bergen, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Rosenlund', 'Affiliation': 'Skretting Aquaculture Research Centre AS, PO Box 48, 4001, Stavanger, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Mellgren', 'Affiliation': 'Mohn Nutrition Research Laboratory, Department of Clinical Science, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Per Magne', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Oddrun Anita', 'Initials': 'OA', 'LastName': 'Gudbrandsen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway. oddrun.gudbrandsen@k1.uib.no.'}]",European journal of nutrition,['10.1007/s00394-019-02076-4']
3206,31297752,A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation.,"BACKGROUND


One-lung ventilation (OLV) procedures are essential for most thoracic surgeries, and the most common method is intubation with a conventional double-lumen tube (cDLT) and bronchoscopy to verify correct tube placement.
OBJECTIVE


The objective of this study was to conduct a cost-effectiveness analysis comparing the VivaSight double-lumen tube (DL) and a cDLT for OLV procedures.
METHODS


A cost-effectiveness analysis was conducted from a healthcare sector perspective in Denmark using a decision analytic model to assess the potential effects and costs of using VivaSight-DL as an alternative to a cDLT with a reusable bronchoscope. Costs were determined using a micro-costing approach. The effectiveness measure was the number of times that fiberoptic confirmation of the tube placement during intubation or surgery was unnecessary and thus avoided. The effectiveness input was from a randomized controlled trial (n = 52). Both deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of the results.
RESULTS


Fiberoptic confirmation of tube placement was only necessary in two (6.66%) procedures using VivaSight-DL. The cost of using VivaSight-DL was $US299.96 per procedure versus $US347.61 for a cDLT with a reusable bronchoscope. The incremental cost-effectiveness ratio was - $US51.06 per bronchoscopy avoided. The base-case analysis indicated that the use of VivaSight-DL was cost effective compared with the use of a cDLT with reusable bronchoscope. Sensitivity analyses showed that the results were robust and that VivaSight-DL was more effective and less costly.
CONCLUSION


This study suggests that VivaSight-DL is associated with cost savings and reductions in bronchoscope use to verify correct tube placement. The conclusion is based on the results from a single institution. To clarify whether VivaSight-DL is cost effective in larger or global clinical settings, further economic evaluations should be performed.",2020,"RESULTS


Fiberoptic confirmation of tube placement was only necessary in two (6.66%) procedures using VivaSight-DL.",['Adult Patients'],"['VivaSight double-lumen tube (DL', 'VivaSight-DL', 'VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube', 'Undergoing Thoracic Surgery']","['incremental cost-effectiveness ratio', 'cost of using VivaSight-DL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0548904,"RESULTS


Fiberoptic confirmation of tube placement was only necessary in two (6.66%) procedures using VivaSight-DL.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Larsen', 'Affiliation': 'Aalborg University, Niels Jernes Vej 10, 9220, Aalborg, Denmark. larsenbk@hotmail.com.'}, {'ForeName': 'Jimmy Højberg', 'Initials': 'JH', 'LastName': 'Holm', 'Affiliation': 'Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense, Denmark.'}, {'ForeName': 'Tove Nørgaard', 'Initials': 'TN', 'LastName': 'Sauer', 'Affiliation': 'Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Andersen', 'Affiliation': 'Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense, Denmark.'}]",PharmacoEconomics - open,['10.1007/s41669-019-0163-y']
3207,31383231,NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Compare treatment efficacy and objective adherence between the NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP) in patients with exclusive positional obstructive sleep apnea (ePOSA) defined as a supine apnea-hypopnea index (sAHI) ≥ 2 times the nonsupine AHI (nsAHI) and a nsAHI < 10 events/h.
METHODS


This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI < 10 events/h) or (AHI > 10 and < 15 events/h with daytime sleepiness and nsAH < 5 events/h). Polysomnography and objective adherence determination (device data) were performed at the end of each 6-week treatment. Patient device preference was determined at the end of the study.
RESULTS


A total of 117 participants were randomized (58 SPT first, 59 APAP first). Of these, 112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort). The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001). The mean AHI difference (SPT-APAP) was 3.58 events/h with a one sided 95% confidence interval upper bound of 4.96 events/h (< the prestudy noninferiority margin of 5 events/h). The average nightly adherence (all nights) was greater on SPT (345.3 ± 111.22 versus 286.98 ± 128.9 minutes,  P  < .0001). Participants found the SPT to be more comfortable and easier to use and 53% reported a preference for SPT assuming both devices were equally effective.
CONCLUSIONS


Treatment with SPT resulted in non-inferior treatment efficacy and greater adherence compared to APAP in ePOSA suggesting that SPT is an effective treatment for this group.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea; Identifier: NCT03061071; URL: https://clinicaltrials.gov/ct2/show/NCT03061071.",2019,"The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001).","['Positional Obstructive Sleep Apnea', '117 participants were randomized (58 SPT first, 59 APAP first', '112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort', 'naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI', 'patients with exclusive positional obstructive sleep apnea (ePOSA']","['NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure', 'NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP', 'SPT']","['Polysomnography and objective adherence determination (device data', 'mean AHI difference (SPT-APAP', 'supine apnea-hypopnea index (sAHI) ≥', 'nonsupine AHI (nsAHI) and a nsAHI', 'average nightly adherence']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]",117.0,0.0276488,"The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Uhles', 'Affiliation': 'Clayton Sleep Institute, Maplewood, Missouri.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Abaluck', 'Affiliation': 'Paoli Hospital Sleep Center, Paoli, Pennsylvania.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Winslow', 'Affiliation': 'Norton Clinical Research Group, Louisville, Kentucky.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Schweitzer', 'Affiliation': ""St. Luke's Hospital, Chesterfield, Missouri.""}, {'ForeName': 'Raymond A', 'Initials': 'RA', 'LastName': 'Gaskins', 'Affiliation': 'Med One Sleep, Fayetteville, North Carolina.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Doekel', 'Affiliation': 'Sleep Disorders Center of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Helene A', 'Initials': 'HA', 'LastName': 'Emsellem', 'Affiliation': 'The Center for Sleep and Wake Disorders, Chevy Chase, Maryland.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7868']
3208,31383235,Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients.,"STUDY OBJECTIVES


Patients with obstructive sleep apnea (OSA) have been shown to have high levels of inflammatory markers. Anti-inflammatory treatment with montelukast and intranasal steroids have demonstrated efficacy for mild OSA in children; this has not been fully evaluated in adults. This study investigated the response of mild OSA in adults to anti-inflammatory medical therapy.
METHODS


Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG) were recruited to a prospective double-blind, randomized control trial. Patients were treated for 12 weeks with montelukast and fluticasone or placebo. All underwent a pretreatment and posttreatment PSG. Epworth Sleepiness Scale (ESS) score was obtained pretreatment and at 6 and 12 weeks posttreatment.
RESULTS


A total of 26 patients completed the study with 13 in each group. Mean age in the treatment and placebo groups were 58.3 ± 10.3 and 54.8 ± 14 years, respectively. There was no significant difference between groups reporting nasal congestion ( P  = .186), rhinitis ( P  = .666), or snoring ( P  = .177). There was no difference in the pretreatment ESS score ( P  = .077), body mass index ( P  = .173), or AHI ( P  = .535). The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05). Neither group showed significant change in AHI. In patients in the treatment group, the 6- and 12-week follow-up ESS scores were not significantly different from pretreatment scores ( P  = .37-.46).
CONCLUSIONS


Intranasal steroids and montelukast did not decrease AHI; however, total sleep time and percent of stage R sleep significantly increased. Self-reported improvement could be explained by observed changes in sleep parameters. Larger prospective studies could help elucidate the effects of medical therapy on adult patients with OSA.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults; Identifier: NCT01089647; URL: https://clinicaltrials.gov/ct2/show/record/NCT01089647.",2019,The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05).,"['Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG', 'adults to anti-inflammatory medical therapy', 'Adult Patients', 'mild OSA in children', 'Patients with obstructive sleep apnea (OSA', '26 patients completed the study with 13 in each group', 'adult patients with OSA', 'Mild Obstructive Sleep Apnea in Adults']","['Title: Montelukast and Nasa ICS', 'montelukast and fluticasone or placebo', 'placebo', 'Medical Therapy', 'montelukast and intranasal steroids']","['nasal congestion', 'total sleep time and percent of stage R sleep', 'stage R sleep', 'Epworth Sleepiness Scale (ESS) score', 'total sleep time', 'body mass index', 'pretreatment ESS score', 'AHI', 'Mild Obstructive Sleep Apnea']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0242776', 'cui_str': 'NASA'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",,0.045252,The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05).,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Smith', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sarber', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Charlene P', 'Initials': 'CP', 'LastName': 'Spiceland', 'Affiliation': 'College School of Business, Simmons University, Boston, Massachusetts.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Ishman', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Augelli', 'Affiliation': 'Weill Medical College, Cornell University, New York, New York.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Romaker', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7876']
3209,31390464,Integrated specialized atrial fibrillation clinics reduce all-cause mortality: post hoc analysis of a randomized clinical trial.,"AIMS


An integrated chronic care programme in terms of a specialized outpatient clinic for patients with atrial fibrillation (AF), has demonstrated improved clinical outcomes. The aim of this study is to assess all-cause mortality in patients in whom AF management was delivered through a specialized outpatient clinic offering an integrated chronic care programme.
METHODS AND RESULTS


Post hoc analysis of a Prospective Randomized Open Blinded Endpoint Clinical trial to assess all-cause mortality in AF patients. The study included 712 patients with newly diagnosed AF, who were referred for AF management to the outpatient service of a University hospital. In the specialized outpatient clinic (AF-Clinic), comprehensive, multidisciplinary, and patient-centred AF care was provided, i.e. nurse-driven, physician supervised AF treatment guided by software based on the latest guidelines. The control group received usual care by a cardiologist in the regular outpatient setting.After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014]. This included cardiovascular mortality in 4 AF-Clinic patients (1.1%) and 14 patients (3.9%) in usual care (HR 0.28; 95% CI 0.09-0.85; P = 0.025). Further, 9 patients (2.5%) died in the AF-Clinic arm due to a non-cardiovascular reason and 15 patients (4.2%) in the usual care arm (HR 0.59; 95% CI 0.26-1.34; P = 0.206).
CONCLUSION


An integrated specialized AF-Clinic reduces all-cause mortality compared with usual care. These findings provide compelling evidence that an integrated approach should be widely implemented in AF management.",2019,"After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014].","['patients with atrial fibrillation (AF', 'AF patients', '712 patients with newly diagnosed AF, who were referred for AF management to the outpatient service of a University hospital', 'patients in whom AF management was delivered through a specialized outpatient clinic offering an integrated chronic care programme']",['usual care by a cardiologist in the regular outpatient setting'],"['cause mortality', 'cardiovascular mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0086751', 'cui_str': 'Outpatient Services'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0175906', 'cui_str': 'Cardiologists'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",712.0,0.0512359,"After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014].","[{'ForeName': 'Jeroen M L', 'Initials': 'JML', 'LastName': 'Hendriks', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, and Cardiovascular Research Institute Maastricht (CARIM), PO Box 5800, 6202 AZ, Maastricht, The Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Tieleman', 'Affiliation': 'Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hubertus J M', 'Initials': 'HJM', 'LastName': 'Vrijhoef', 'Affiliation': 'Department Patient and Care, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Wijtvliet', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, and Cardiovascular Research Institute Maastricht (CARIM), PO Box 5800, 6202 AZ, Maastricht, The Netherlands.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Centre for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': 'Department of Epidemiology, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Centre for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, and Cardiovascular Research Institute Maastricht (CARIM), PO Box 5800, 6202 AZ, Maastricht, The Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz209']
3210,31392958,Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.,"BACKGROUND


Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI.
OBJECTIVE


To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds.
DESIGN


Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved.
SETTING


Usual NHS care.
PARTICIPANTS


Patients undergoing elective/non-elective abdominal surgery, including caesarean section.
INTERVENTIONS


Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'.
MAIN OUTCOME MEASURES


Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers.
DATA SOURCES


Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals.
RESULTS


Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple,  n  = 133; glue,  n  = 129; no dressing,  n  = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy ( c -statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
LIMITATIONS


Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres.
CONCLUSIONS


A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks.
TRIAL REGISTRATION


Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).",2019,"The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
","['primary surgical wounds', 'Phase A - we interviewed 102 participants', 'Patients undergoing elective/non-elective abdominal surgery, including caesarean section', 'surgical site infection after abdominal surgery', 'no dressing,  n \u2009=\u2009132', 'We interviewed 55 participants', '862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple,  n \u2009=\u2009133; glue,  n \u2009=\u2009129', 'Phase B - from 4 March 2016 to 30 November 2016']","[""Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing"", 'dressing types or no dressing to reduce SSI']","['SSI questionnaire response rate overall', 'SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT', 'SSI questionnaire', 'diagnostic accuracy', 'SSI']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0017780', 'cui_str': 'Glues'}]","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0017780', 'cui_str': 'Glues'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0567460', 'cui_str': 'Dressing practice (regime/therapy)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",102.0,0.100827,"The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
","[{'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Rooshenas', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rhiannon C', 'Initials': 'RC', 'LastName': 'Macefield', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Nicky J', 'Initials': 'NJ', 'LastName': 'Welton', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Waterhouse', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Torrance', 'Affiliation': 'Department of Surgery, Sandwell and West Birmingham NHS Trust, West Bromwich, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Strong', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Siassakos', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Seligman', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Rickard', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pullyblank', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pope', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Pinkney', 'Affiliation': 'Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Owais', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': ""O'Callaghan"", 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Nepogodiev', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Khaldoun', 'Initials': 'K', 'LastName': 'Nadi', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Murkin', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tonia', 'Initials': 'T', 'LastName': 'Munder', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Milne', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Messenger', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Christel M', 'Initials': 'CM', 'LastName': 'McMullan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Mathers', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Morwena', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lovegrove', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Longman', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lloyd', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Korwar', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hill', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hamdan', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Hannah Gould', 'Initials': 'HG', 'LastName': 'Brown', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'Musculoskeletal Research Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glasbey', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fryer', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jo C', 'Initials': 'JC', 'LastName': 'Dumville', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Draycott', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cotton', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Coast', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Calvert', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Byrne', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Oliver D', 'Initials': 'OD', 'LastName': 'Brown', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katarzyna D', 'Initials': 'KD', 'LastName': 'Bera', 'Affiliation': 'Clinical Academic Graduate School, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bamford', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Danya', 'Initials': 'D', 'LastName': 'Bakhbakhi', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Atif', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Lazaros', 'Initials': 'L', 'LastName': 'Andronis', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Piriyankan', 'Initials': 'P', 'LastName': 'Ananthavarathan', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23390']
3211,31738447,Hypervolemia does not cause degradation of the endothelial glycocalyx layer during open hysterectomy performed under sevoflurane or propofol anesthesia.,"BACKGROUND


Fluid-induced hypervolemia may stimulate the release of natriuretic peptides and cause degradation (shedding) of the endothelial glycocalyx layer. Sevoflurane is believed to protect the glycocalyx, but the importance of using sevoflurane to prevent shedding during routine surgery is unclear.
METHODS


The plasma concentrations of brain natriuretic peptide and two biomarkers of glycocalyx shedding, syndecan-1, and heparan sulfate, were measured in 26 patients randomized to receive general anesthesia with sevoflurane or propofol during open abdominal hysterectomy. The fluid therapy consisted of 25 mL/kg (approximately 2 L) of Ringer´s lactate over 30 minutes. Blood hemoglobin and plasma albumin were used to indicate plasma volume expansion and capillary leakage.
RESULTS


The plasma concentrations of brain natriuretic peptide and shedding products showed low levels throughout the surgery (median brain natriuretic peptide, 21 ng/L; syndecan-1, 12.9 ng/mL; and heparan sulfate, 6.5 µg/mL), but the heparan sulfate concentration increased 2 hours post-operatively (to 17.3 µg/mL, P < .005). No differences were noted between the propofol and sevoflurane groups in any of the measured parameters. Albumin was apparently recruited to the bloodstream during the first 20 minutes, when the intravascular retention of infused fluid was almost 100%. The urine flow was <1 mL/min, despite the vigorous volume loading.
CONCLUSIONS


No relevant elevations of brain natriuretic peptide or degradation products of the glycocalyx layer were observed when hypervolemia was induced during open abdominal hysterectomy performed with sevoflurane or propofol anesthesia. Plasma volume expansion from Ringer´s lactate was pronounced.",2020,"The plasma concentrations of brain natriuretic peptide and shedding products showed low levels throughout the surgery (median brain natriuretic peptide, 21 ng/L; syndecan-1, 12.9 ng/mL; and heparan sulfate, 6.5 µg/mL), but the heparan sulfate concentration increased 2 h postoperatively (to 17.3 µg/mL, P< 0.005).",['26 patients randomized to receive general anesthesia with'],"['Sevoflurane', 'sevoflurane or propofol', 'propofol', 'sevoflurane', 'sevoflurane or propofol anesthesia']","['plasma concentrations of brain natriuretic peptide', 'heparan sulfate concentration', 'Blood hemoglobin and plasma albumin', 'urine flow']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0019143', 'cui_str': 'Heparan Sulfate'}, {'cui': 'C0005768'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1260311', 'cui_str': 'Plasma Albumin'}, {'cui': 'C0042037'}]",,0.0440358,"The plasma concentrations of brain natriuretic peptide and shedding products showed low levels throughout the surgery (median brain natriuretic peptide, 21 ng/L; syndecan-1, 12.9 ng/mL; and heparan sulfate, 6.5 µg/mL), but the heparan sulfate concentration increased 2 h postoperatively (to 17.3 µg/mL, P< 0.005).","[{'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Nemme', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Riga Stradins University and Paul Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Krizhanovskii', 'Affiliation': 'Research Unit, Södertälje Hospital, Södertälje, Sweden.'}, {'ForeName': 'Stelia', 'Initials': 'S', 'LastName': 'Ntika', 'Affiliation': 'Research Unit, Södertälje Hospital, Södertälje, Sweden.'}, {'ForeName': 'Olegs', 'Initials': 'O', 'LastName': 'Sabelnikovs', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Riga Stradins University and Paul Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Indulis', 'Initials': 'I', 'LastName': 'Vanags', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Riga Stradins University and Paul Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hahn', 'Affiliation': 'Research Unit, Södertälje Hospital, Södertälje, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13511']
3212,31144435,A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study.,"AIM


To compare the efficacy and safety of a glucagon-like peptide-1 receptor agonist (GLP1RA) plus basal insulin versus basal-bolus insulin treatment in patients with very uncontrolled type 2 diabetes.
MATERIALS AND METHODS


The SIMPLE study was a 6-month pragmatic, randomized, open-label trial testing the effectiveness of two approaches to treat patients with type 2 diabetes and HbA1c ≥10%. We randomized patients to detemir plus liraglutide or detemir plus aspart (before each meal). The primary endpoint was change in HbA1c; changes in body weight, insulin dose, hypoglycaemia and diabetes-related quality-of-life were secondary outcomes.
RESULTS


We randomized 120 participants aged 47.4 ± 9.5 years, Hispanic 40%, African American 42%, diabetes duration 10 [25th-75th percentile (6 to 15)] years, body mass index 37.2 ± 10.3 kg/m 2  . HbA1c decreased more with GLP1RA plus basal insulin [12.2% (95% CI 11.8% to 12.6%) to 8.1% (95% CI 7.4% to 8.7%)] compared with basal-bolus insulin [11.8% (95% CI 11.5% to 12.2%) to 8.8% (95% CI 88.1% to 9.55%)]; estimated treatment difference (ETD) of -1.1% (95% CI -2.0% to -0.1%) (non-inferiority margin 0.4% and P = .0001, superiority P = .026). Compared with basal-bolus insulin, treatment with GLP1RA plus basal insulin led to a body weight ETD of -3.7 kg (95% CI -5.8 to -1.5; P = .001), fewer patients experiencing hypoglycaemia [66.1% vs 35.2% (P = .002)], and greater improvements in general/current health perception, treatment satisfaction, and fear of hypoglycaemia, while taking a lower total daily dose of insulin [estimated treatment ratio 0.68 (95% CI 0.55 to 0.84)].
CONCLUSIONS


In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life. This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen.",2019,HbA1c decreased more with GLP1RA plus basal insulin [12.2% (95% CI 11.8% to 12.6%) to 8.1% (95% CI 7.4% to 8.7%)] compared with basal-bolus insulin [11.8% (95% CI 11.5% to 12.2%) to 8.8% (95% CI 88.1% to 9.55%)]; estimated treatment difference (ETD) of -1.1% (95% CI -2.0% to -0.1%) (non-inferiority margin 0.4% and P =,"['120 participants aged 47.4\u2009±\u20099.5 years, Hispanic 40%, African American 42%, diabetes duration 10 [25th-75th percentile (6 to 15)] years, body mass index 37.2\u2009±\u200910.3 kg/m 2  ', 'patients with type 2 diabetes and HbA1c ≥10', 'patients with very uncontrolled type 2 diabetes', 'patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a']","['GLP1RA plus basal insulin', 'detemir plus liraglutide or detemir plus aspart', 'glucagon-like peptide-1 receptor agonist plus basal-bolus insulin', 'glucagon-like peptide-1 receptor agonist (GLP1RA) plus basal insulin versus basal-bolus insulin treatment']","['glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life', 'general/current health perception, treatment satisfaction, and fear of hypoglycaemia', 'change in HbA1c; changes in body weight, insulin dose, hypoglycaemia and diabetes-related quality-of-life', 'GLP1RA plus basal insulin', 'efficacy and safety', 'patients experiencing hypoglycaemia']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",120.0,0.236971,HbA1c decreased more with GLP1RA plus basal insulin [12.2% (95% CI 11.8% to 12.6%) to 8.1% (95% CI 7.4% to 8.7%)] compared with basal-bolus insulin [11.8% (95% CI 11.5% to 12.2%) to 8.8% (95% CI 88.1% to 9.55%)]; estimated treatment difference (ETD) of -1.1% (95% CI -2.0% to -0.1%) (non-inferiority margin 0.4% and P =,"[{'ForeName': 'Marconi', 'Initials': 'M', 'LastName': 'Abreu', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tumyan', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elhassan', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Peicher', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Papacostea', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Perihan', 'Initials': 'P', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Muhammad S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Laurentiu M', 'Initials': 'LM', 'LastName': 'Pop', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Gunasekaran', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Luigi F', 'Initials': 'LF', 'LastName': 'Meneghini', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Adams-Huet', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Xilong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Sciences, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center at Dallas, Dallas, Texas.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13794']
3213,31402574,Two years clinical outcomes with the state-of-the-art PCI for the treatment of bifurcation lesions: A sub-analysis of the SYNTAX II study.,"BACKGROUND


Bifurcation PCI is associated with a lower rate of procedural success, especially in multivessel disease patients. We aimed to determine the impact of bifurcation treatment on 2-years clinical outcomes when a state-of-the-art PCI strategy (heart team decision-making using the SYNTAX score II, physiology guided coronary stenosis assessment, thin strut bioresorbable polymer drug-eluting stent, and intravascular ultrasound guidance) is followed.
METHODS


Three-vessel disease patients enrolled in the SYNTAX II trial (n = 454) were categorized in patients with (a) ≥1 treated bifurcation (n = 126), and (b) without bifurcation (n = 281). The primary endpoint was the occurrence of major adverse cardio and cerebrovascular events (MACCE-a composite of all-cause death, stroke, any myocardial infarction, or any revascularization) at 2 years. Secondary endpoints were the occurrence of target lesion failure (TLF) defined as cardiac death, target-vessel myocardial infarction and ischemia-driven target lesion revascularization, and the individual components of the composite primary endpoint, as well as stent thrombosis.
RESULTS


A total of 145 bifurcation were treated in 126 patients. At 2 years, MACCE occurred in 75/407 patients (20.7% for bifurcation versus 17.5% for nonbifurcation, hazard ratio [HR] of 1.28, CI95% 0.78-2.08, p = .32). TLF presented a trend toward higher occurrence in bifurcation (16.8% vs. 10.8%, HR 1.75, CI95% 0.99-3.09, p = .053). Definite stent thrombosis did not differ at 2-year between groups (0.8% for the bifurcation vs. 0.7% for the nonbifurcation, p = .92).
CONCLUSION


Bifurcation treatment in patients with three-vessel disease undergoing state-of-the-art PCI had similar event rate of MACCE but was associated with a trend toward higher incidence of TLF compared with nonbifurcation lesions.",2020,"Definite stent thrombosis did not differ at 2-year between groups (0.8% for the bifurcation vs. 0.7% for the nonbifurcation, p = .92).
","['Three-vessel disease patients enrolled in the SYNTAX II trial (n = 454) were categorized in patients with (a) ≥1 treated bifurcation (n = 126), and (b) without bifurcation (n = 281', 'multivessel disease patients', 'A total of 145 bifurcation were treated in 126 patients']","['MACCE', 'TLF']","['occurrence of target lesion failure (TLF) defined as cardiac death, target-vessel myocardial infarction and ischemia-driven target lesion revascularization, and the individual components of the composite primary endpoint, as well as stent thrombosis', 'occurrence of major adverse cardio and cerebrovascular events (MACCE-a composite of all-cause death, stroke, any myocardial infarction, or any revascularization', 'Definite stent thrombosis']","[{'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}]",[],"[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}]",126.0,0.0944657,"Definite stent thrombosis did not differ at 2-year between groups (0.8% for the bifurcation vs. 0.7% for the nonbifurcation, p = .92).
","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Komiyama', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'de Vries', 'Affiliation': 'Cardialysis BV, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Department of Cardiology Belfast Health & Social Care Trust, Belfast, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': '1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Department of Cardiology, Hospital Universitario la Paz, Madrid, Spain.'}, {'ForeName': 'Vasim', 'Initials': 'V', 'LastName': 'Farrooq', 'Affiliation': 'Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Banning', 'Affiliation': 'Department of Cardiology, John Radcliffe Hospital, Cardiology, Oxford, UK.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Cardialysis BV, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, Imperial College of London, London, UK.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28422']
3214,32115759,"Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial.","BACKGROUND AND AIMS


We evaluated the safety and efficacy of cilofexor (formerly GS-9674), a small-molecule nonsteroidal agonist of farnesoid X receptor, in patients with nonalcoholic steatohepatitis (NASH).
APPROACH AND RESULTS


In this double-blind, placebo-controlled, phase 2 trial, 140 patients with noncirrhotic NASH, diagnosed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥8% and liver stiffness ≥2.5 kPa by magnetic resonance elastography (MRE) or historical liver biopsy, were randomized to receive cilofexor 100 mg (n = 56), 30 mg (n = 56), or placebo (n = 28) orally once daily for 24 weeks. MRI-PDFF, liver stiffness by MRE and transient elastography, and serum markers of fibrosis were measured at baseline and week 24. At baseline, median MRI-PDFF was 16.3% and MRE-stiffness was 3.27 kPa. At week 24, patients receiving cilofexor 100 mg had a median relative decrease in MRI-PDFF of -22.7%, compared with an increase of 1.9% in those receiving placebo (P = 0.003); the 30-mg group had a relative decrease of -1.8% (P = 0.17 vs. placebo). Declines in MRI-PDFF of ≥30% were experienced by 39% of patients receiving cilofexor 100 mg (P = 0.011 vs. placebo), 14% of those receiving cilofexor 30 mg (P = 0.87 vs. placebo), and 13% of those receiving placebo. Serum gamma-glutamyltransferase, C4, and primary bile acids decreased significantly at week 24 in both cilofexor treatment groups, whereas significant changes in Enhanced Liver Fibrosis scores and liver stiffness were not observed. Cilofexor was generally well-tolerated. Moderate to severe pruritus was more common in patients receiving cilofexor 100 mg (14%) than in those receiving cilofexor 30 mg (4%) and placebo (4%).
CONCLUSIONS


Cilofexor for 24 weeks was well-tolerated and provided significant reductions in hepatic steatosis, liver biochemistry, and serum bile acids in patients with NASH. ClinicalTrials.gov No. NCT02854605.",2020,"Serum gamma-glutamyltransferase, C4, and primary bile acids decreased significantly at week 24 in both cilofexor treatment groups, whereas significant changes in ELF and liver stiffness were not observed.","['patients with NASH', 'patients with nonalcoholic steatohepatitis (NASH', '140 non-cirrhotic patients with NASH diagnosed by', 'Non-Cirrhotic Patients with Nonalcoholic Steatohepatitis']","['placebo', 'cilofexor (formerly GS-9674', 'Cilofexor', 'magnetic resonance elastography (MRE', 'cilofexor', 'magnetic resonance imaging-proton density fat fraction (MRI-PDFF']","['median MRI-PDFF', 'MRI-PDFF, liver stiffness by MRE and transient elastography, and serum markers of fibrosis', 'tolerated', 'MRI-PDFF', 'ELF and liver stiffness', 'Moderate to severe pruritus', 'hepatic steatosis, liver biochemistry, and serum bile acids', 'Serum gamma-glutamyltransferase, C4, and primary bile acids', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1518156', 'cui_str': 'Magnetic Resonance Elastography'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",140.0,0.382122,"Serum gamma-glutamyltransferase, C4, and primary bile acids decreased significantly at week 24 in both cilofexor treatment groups, whereas significant changes in ELF and liver stiffness were not observed.","[{'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Elkhashab', 'Affiliation': 'Toronto Liver Center, Toronto, ON, Canada.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Trotter', 'Affiliation': 'Texas Digestive Disease Consultants, Dallas, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Herring', 'Affiliation': 'Quality Medical Research, Nashville, TN.'}, {'ForeName': 'Sergio E', 'Initials': 'SE', 'LastName': 'Rojter', 'Affiliation': 'Ruane Clinical Research, Los Angeles, CA.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, Rialto, CA.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Greenbloom', 'Affiliation': 'Toronto Digestive Disease Associates, Woodbridge, ON, Canada.'}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Jayakumar', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Mercy Health, Richmond, VA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Freilich', 'Affiliation': 'Kansas City Research Institute, Kansas City, MO.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Gane', 'Affiliation': 'Liver Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Harting', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Billin', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'C Stephen', 'Initials': 'CS', 'LastName': 'Djedjos', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Middleton', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31205']
3215,32017994,DIAL now protocol: A randomized trial examining the provision of phone coaching to those with sub-optimal early weight loss during an Internet weight management program.,"BACKGROUND


While low-intensity Internet-delivered weight loss (IDWL) programs are efficacious, many patients fail to achieve clinically significant weight loss (WL). Given the positive association between 4-week and post-treatment WL, providing a more intensive intervention for those with sub-optimal 4-week WL may improve outcomes for a greater proportion of individuals. This stepped-care approach would minimize cost by reserving more aggressive treatment for those with sub-optimal early WL.
OBJECTIVE


This randomized trial examines whether the provision of brief or extended phone coaching for those with sub-optimal early WL improves 4- and 12-month WL when compared to no coaching. Secondary aims include examination of cost/kg WL and intervention engagement.
METHODS


450 individuals (age 18-70 years, BMI: 25-45 kg/m 2 ) will be randomized to: 1) IDWL+3 weeks of coaching ('Brief'), 2) IDWL+12 weeks of coaching ('Extended'), or 3) IDWL only ('Control'). All individuals will receive a 4-month IDWL program followed by an 8-month IDWL maintenance program. At week 4, individuals will be classified as early sub-optimal responders (<4% WL) or initial responders (≥4% WL). Individuals with sub-optimal early WL randomized to 'Brief' or 'Extended' will receive 3 and 12 weeks of phone coaching respectively, starting at week 5. Those with sub-optimal early WL randomized to 'Control', and initial responders will not receive any coaching. Assessments will occur at 4 and 12 months.
DISCUSSION


Study findings can inform the development of more effective IDWL programs. This model which provides additional support to those with sub-optimal early WL can easily be translated into healthcare and community settings.",2020,"Individuals with sub-optimal early WL randomized to 'Brief' or 'Extended' will receive 3 and 12 weeks of phone coaching respectively, starting at week 5.",['450 individuals (age 18-70\u202fyears'],"['extended phone coaching', 'phone coaching', ""IDWL+3\u202fweeks of coaching ('Brief'), 2) IDWL+12\u202fweeks of coaching ('Extended'), or 3) IDWL only ('Control""]",['examination of cost/kg WL and intervention engagement'],"[{'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",450.0,0.0450397,"Individuals with sub-optimal early WL randomized to 'Brief' or 'Extended' will receive 3 and 12 weeks of phone coaching respectively, starting at week 5.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Unick', 'Affiliation': ""Warren Alpert Medical School at Brown University and The Miriam Hospital's Weight Control and Diabetes Research Center, Providence, RI, USA. Electronic address: junick@lifespan.org.""}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Demos', 'Affiliation': ""Warren Alpert Medical School at Brown University and The Miriam Hospital's Weight Control and Diabetes Research Center, Providence, RI, USA.""}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': ""Warren Alpert Medical School at Brown University and The Miriam Hospital's Weight Control and Diabetes Research Center, Providence, RI, USA.""}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': ""Warren Alpert Medical School at Brown University and The Miriam Hospital's Weight Control and Diabetes Research Center, Providence, RI, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': ""Warren Alpert Medical School at Brown University and The Miriam Hospital's Weight Control and Diabetes Research Center, Providence, RI, USA.""}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': ""Warren Alpert Medical School at Brown University and The Miriam Hospital's Weight Control and Diabetes Research Center, Providence, RI, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105953']
3216,31186388,Comparison of extracorporeal shock wave therapy with custom foot orthotics in plantar fasciitis treatment: A prospective randomized one-year follow-up study.,"PURPOSE


Plantar fasciitis (PF) is characterized by the degeneration of the plantar fascia, leading to heel pain. We aimed to investigate the effectiveness of extracorporeal shock wave therapy (ESWT) and custom foot orthotics (CFO).
METHOD


The study was planned as a prospective randomized controlled study. In total, 83 patients were evaluated. The patients were divided into two groups: patients treated with ESWT (group I, n=40) and patients treated with CFO (group II, n=43). Visual analogue scale (VAS) was used to evaluate pain in the morning, evening, at rest and while walking. Foot Function Index (FFI) was used to evaluate foot functions, and Foot Health Status Questionnaire (FHSQ) was used to evaluate foot health.
RESULTS


Both group I and group II achieved significant improvements in our evaluation parameters (morning and evening pain) at 4, 12 and 24 weeks compared with their baseline values (P<0.001), and significant improvement observed in the group II continued at 48 weeks (P<0.05); however, there was no significant difference in some parameters in the group I after treatment compared with their baseline values (P>0.05).
CONCLUSION


Both treatment ESWT and CFO can use interchangebably. Neither method was superior in treating plantar fasciitis.",2019,"Both group I and group II achieved significant improvements in our evaluation parameters (morning and evening pain) at 4, 12 and 24 weeks compared with their baseline values (P<0.001), and significant improvement observed in the group II continued at 48 weeks (P<0.05); however, there was no significant difference in some parameters in the group","['83 patients were evaluated', 'plantar fasciitis treatment']","['ESWT', 'extracorporeal shock wave therapy (ESWT) and custom foot orthotics (CFO', 'extracorporeal shock wave therapy with custom foot orthotics', 'CFO']","['Foot Function Index (FFI', 'Visual analogue scale (VAS', 'evaluation parameters (morning and evening pain', 'foot functions, and Foot Health Status Questionnaire (FHSQ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0016504', 'cui_str': 'Foot'}]","[{'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",83.0,0.0250634,"Both group I and group II achieved significant improvements in our evaluation parameters (morning and evening pain) at 4, 12 and 24 weeks compared with their baseline values (P<0.001), and significant improvement observed in the group II continued at 48 weeks (P<0.05); however, there was no significant difference in some parameters in the group","[{'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Çağlar Okur', 'Affiliation': 'Physical Therapy and Rehabilitation, Dr Sadi Konuk Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Abdulkadir', 'Initials': 'A', 'LastName': 'Aydın', 'Affiliation': ''}]",Journal of musculoskeletal & neuronal interactions,[]
3217,32101065,A Comparison of the Relative Safety and Efficacy of Laparoscopic Choledochotomy with Primary Closure and Endoscopic Treatment for Bile Duct Stones in Patients with Cholelithiasis.,"Background:  To date, several clinical trials have demonstated that both one-stage laparoscopic cholecystectomy (LC) combined with common bile duct exploration (LC+BDE) with primary closure and one-stage LC combined with endoscopic stone extraction (LC+ESE) are the two primary clinical approaches to treat cholelithiasis. However, no studies to date have directly compared the LC+BDE with primary closure and one-stage LC+ESE procedures. We, therefore, conducted a retrospective analysis of patients with cholelithiasis who had been treated through LC+ESE or LC+BDE to compare these two approaches for the treatment of cholecystitis and common bile duct stones (CCBDS).  Methods:  Consecutive CCBDS patients with cholelithiasis in our hospital who were diagnosed through Media Resource Control Protocol (MRCP) and ultrasound between June 2010 and February 2017 were randomly assigned to undergo either LC+ESE or LC+BDE, as both procedures are routinely used to treat cholelithiasis in our hospital. All patients were made aware of the risks and benefits of the surgery preoperatively, and this study was approved by the ethics committee of our institute. Outcomes in these two groups, including rates of success and reasons for operative failure, were then compared, as were data pertaining to patient demographics, clinical findings, postoperative stay duration, and medical expenses. In addition, biliary reflux as measured through computed tomography or gastrointestinal imaging was monitored for a minimum of 2 years.  Results:  In total, 207 CCBDS patients were identified during the study period and were randomized into the LC+ESE ( n  = 103) or LC+BDE ( n  = 104) treatment groups. We found that patients treated through LC+BDE achieved a significantly higher success rate than that achieved in patients treated through LC+ESE (93.3% versus 82.5%;  P  < .05). Specifically, the LC+BDE with primary closure procedure failed in patients with impacted stones located at the end of the common bile duct (CBD) and in those with stenosis of the sphincter of Oddi. The only variable that differed significantly between these two treatment groups was stone location. Variables other than stone location, CBD size, and stone size did not differ significantly between the two groups. However, the LC+BDE treatment was associated with significant reductions in patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative to the LC+ESE treatment.  Conclusions:  We found that LC+BDE with primary closure was a safer and more effective means of treated CCBDS patients than was the LC+ESE procedure and that it was not associated with risks of sphincterotomy of duodenal papilla (EST)- or T-tube-related complications. However, our data also clearly indicate that LC+BDE cannot replace LC+ESE in all patients, and that as such both approaches should be considered as being complementary to one another, with their relative advantages in a given patient being defined based upon local resource availability and expertise. In addition, when the LC+ESE procedure fails then the LC+BDE treatment can be safely employed as a salvage approach.",2020,"However, the LC+BDE treatment was associated with significant reductions in patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative to the LC+ESE treatment.  ","['Consecutive CCBDS patients with cholelithiasis in our hospital who were diagnosed through Media Resource Control Protocol (MRCP) and ultrasound between June 2010 and February 2017', 'Patients with Cholelithiasis', 'patients with cholelithiasis who had been treated through LC+ESE or LC+BDE to compare these two approaches for the treatment of cholecystitis and common bile duct stones (CCBDS', '207 CCBDS patients']","['Laparoscopic Choledochotomy with Primary Closure and Endoscopic Treatment', 'laparoscopic cholecystectomy (LC) combined with common bile duct exploration (LC+BDE) with primary closure and one-stage LC combined with endoscopic stone extraction (LC+ESE', 'LC+BDE', 'LC+ESE', 'LC+ESE or LC+BDE']","['stone location', 'rates of success and reasons for operative failure', 'success rate', 'patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative', 'patient demographics, clinical findings, postoperative stay duration, and medical expenses', 'biliary reflux', 'CBD size, and stone size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008350', 'cui_str': 'Cholelithiasis'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008325', 'cui_str': 'Gallbladder Inflammation'}, {'cui': 'C0009438', 'cui_str': 'Common Bile Duct Gall Stones'}]","[{'cui': 'C0391928', 'cui_str': 'Incision of common bile duct (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009437', 'cui_str': 'Choledochus'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",207.0,0.0460479,"However, the LC+BDE treatment was associated with significant reductions in patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative to the LC+ESE treatment.  ","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Graduate Department of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Changzhong', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': 'Department of General Surgery, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'JingWang', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, China.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0775']
3218,31667747,"Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial.","BACKGROUND


Poor sleep is common among adults with chronic low back pain (cLBP), but the influence of cLBP treatments, such as yoga and physical therapy (PT), on sleep quality is under studied.
OBJECTIVE


Evaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP.
DESIGN


Secondary analysis of a randomized controlled trial.
SETTING


Academic safety-net hospital and 7 affiliated community health centers.
PARTICIPANTS


A total of 320 adults with cLBP.
INTERVENTION


Twelve weekly yoga classes, 1-on-1 PT sessions, or an educational book.
MAIN MEASURES


Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21) at baseline, 12 weeks, and 52 weeks. Additionally, we also evaluated how the proportion of participants who achieved a clinically meaningful improvement in sleep quality (> 3-point reduction in PSQI) at 12 weeks varied by changes in pain and physical function at 6 weeks.
KEY RESULTS


Among participants (mean age = 46.0, 64% female, 82% non-white), nearly all (92%) reported poor sleep quality (PSQI > 5) at baseline. At 12 weeks, modest improvements in sleep quality were observed among the yoga (PSQI mean difference [MD] = - 1.19, 95% confidence interval [CI] - 1.82, - 0.55) and PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) groups. Participants who reported a ≥ 30% improvement in pain or physical function at 6 weeks, compared with those who improved < 10%, were more likely to be a sleep quality responder at 12 weeks (odds ratio [OR] = 3.51, 95% CI 1.73, 7.11 and OR = 2.16, 95% CI 1.18, 3.95, respectively). Results were similar at 52 weeks.
CONCLUSION


In a sample of adults with cLBP, virtually all with poor sleep quality prior to intervention, modest but statistically significant improvements in sleep quality were observed with both yoga and PT. Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01343927.",2020,"Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements.
","['participants (mean age\u2009=\u200946.0, 64% female, 82% non-white', 'A total of 320 adults with cLBP', 'adults with cLBP', 'Low-Income Racially Diverse Adults with Chronic Low Back Pain', 'Academic safety-net hospital and 7 affiliated community health centers', 'adults with chronic low back pain (cLBP']","['Yoga, Physical Therapy, and Back Pain Education', 'yoga and PT']","['Sleep quality', 'mid-intervention pain and physical function improvements', 'Pittsburgh Sleep Quality Index (PSQI) global score', 'sleep quality', 'sleep quality responder', 'poor sleep quality', 'pain and physical function', 'pain or physical function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}]",320.0,0.158432,"Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements.
","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA. Eric.Roseen@bmc.org.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gerlovin', 'Affiliation': 'Slone Epidemiology Center, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Femia', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bertisch', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05329-4']
3219,31602530,Glycemic variability indices can be used to diagnose islet transplantation success in type 1 diabetic patients.,"AIMS


High glycemic variability (GV) is the major indication for islet transplantation (IT) in patients with type 1 diabetes (T1D). The actual criteria used to assess graft function do not consider GV improvement. Our study aimed to describe GV indices' evolution in T1D patients who benefited from IT during the TRIMECO trial and to evaluate if thresholds might be defined to diagnose IT success.
METHODS


We collected data from 29 patients of the TRIMECO trial, a clinical trial (NCT01148680) comparing the metabolic efficacy of IT with intensive insulin therapy. Based on CGM data, we analyzed mean glucose level and four GV indices (standard deviation, coefficient of variation, MAGE and GVP) before (M0) and 6 months (M6) after IT.
RESULTS


Each GV index decreased significantly between M0 and M6: SD 53.9 mg/dL [44.6-61.5] versus 20.1 mg/dL [13.5-24.3]; CV 35.2% [30.6-37.7] versus 17.3% [12.0-20.5]; MAGE 134.9 mg/dl [111.2-155.8] versus 51.9 mg/dL [32.4-62.4]; GVP 35.3% [24.9-47.2] versus 12.2% [6.2-18.8] (p ≤ 0.0001). Thresholds diagnosing IT success at 6 months post-transplant were an SD at 22.76 mg/dL (sensibility 88.89%, specificity 80.00%), a CV at 17.47% (sensibility 88.89%, specificity 70.00%), a MAGE at 54.81 mg/dL (sensibility 88.89%, specificity 80.00%) and a GVP at 12.27% (sensibility 88.89%, specificity 70.00%).
CONCLUSIONS


This study confirms a positive impact of IT on GV. The proposed thresholds allow an easy evaluation of IT success using only CGM data and may be a clinical tool for the follow-up of transplanted patients.",2020,Each GV index decreased significantly between M0 and M6: SD 53.9 mg/,"['patients with type 1 diabetes (T1D', 'type 1 diabetic patients', 'T1D patients who benefited from IT during the TRIMECO trial', '29 patients of the TRIMECO trial']","['intensive insulin therapy', 'dL']","['mean glucose level and four GV indices (standard deviation, coefficient of variation, MAGE and GVP', 'GV index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]",,0.0636534,Each GV index decreased significantly between M0 and M6: SD 53.9 mg/,"[{'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Jalbert', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Grenoble Alpes University Hospital, CS10217, 38043, Grenoble, France. mjalbert@chu-grenoble.fr.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Inria, CNRS, Grenoble INP, LJK, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wojtusciszyn', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Forbes', 'Affiliation': 'Inria, CNRS, Grenoble INP, LJK, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bonnet', 'Affiliation': 'Inria, CNRS, Grenoble INP, LJK, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Skaare', 'Affiliation': 'Department of Public Health, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Grenoble Alpes University Hospital, CS10217, 38043, Grenoble, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lablanche', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Grenoble Alpes University Hospital, CS10217, 38043, Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acta diabetologica,['10.1007/s00592-019-01425-3']
3220,31607547,Effect of Oral Nutritional Supplementation With and Without Exercise on Nutritional Status and Physical Function of Adult Hemodialysis Patients: A Parallel Controlled Clinical Trial (AVANTE-HEMO Study).,"OBJECTIVE


Protein energy wasting affects the nutritional status (NS) and physical function (PF) of dialysis patients. Among the different anabolic strategies to improve NS and PF, oral nutritional supplementation (ONS) and resistance exercise (RE) or aerobic exercise (AE) have been shown to be effective. Nevertheless, the combination of both anabolic strategies has not been completely evaluated. The aim of this study is to assess the effect of exercise combined with ONS versus ONS without exercise during hemodialysis sessions on PF and NS indicators.
METHODS


Young hemodialysis patients (29 ± 9.3 years) with predominantly unknown causes of renal disease (80%) were divided into the following 3 groups during a period of 12 weeks: (1) ONS (n = 15), (2) ONS + RE (n = 15), and (3) ONS + AE (n = 15). Anthropometric, biochemical, PF, and quality of life measurements were recorded at baseline and after 3 months. Repeated measures analysis of variance and effect sizes (Cohen's d) were used to assess the effect of exercise and nutrition (ISRCTN registry 10251828).
RESULTS


At the completion of the study, the ONS and ONS + RE groups exhibited statistically significant increases in body weight, body mass index, and in the percentage of fat mass (P < .05); the greatest effect sizes were observed in the ONS + RE group (d = 0.30 for body weight, d = 0.63 for body mass index, and d = 0.90 for the percentage of fat mass). Groups with RE and AE had statistically significant increases and large effect sizes in the six-minute walk test (RE: d = 0.94, P = .02; AE: d = 1.11, P = .03), sit-to-stand test (RE: d = 0.81, P = .041; AE: d = 1.20, P = .002), timed up and go test (RE: d = 1.04, P = .036; AE: d = 1.6, P = .000), and muscle strength (RE: d = 1.01, P = .000; AE: d = 0.60, P = .003). Regarding quality of life, the ONS + RE group had more areas of improvement at the end of the study, followed by the ONS + AE group. No statistically significant differences were found in the repeated measures ANOVA.
CONCLUSIONS


The combination of exercise with ONS had larger effects on PF than on ONS alone. Further studies to examine the impact of exercise on the effect of oral nutritional supplementation in dialysis patients are indicated.",2020,"Groups with RE and AE had statistically significant increases and large effect sizes in the six-minute walk test (RE: d = 0.94, P = .02;","['dialysis patients', 'Young hemodialysis patients (29\xa0±\xa09.3\xa0years) with predominantly unknown causes of renal disease (80', 'Adult Hemodialysis Patients']","['Oral Nutritional Supplementation With and Without Exercise', 'oral nutritional supplementation (ONS) and resistance exercise (RE) or aerobic exercise (AE', 'AE', 'exercise combined with ONS versus ONS without exercise']","['body weight, body mass index', 'Nutritional Status and Physical Function', 'large effect sizes', 'Anthropometric, biochemical, PF, and quality of life measurements', 'muscle strength', 'percentage of fat mass']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0517542,"Groups with RE and AE had statistically significant increases and large effect sizes in the six-minute walk test (RE: d = 0.94, P = .02;","[{'ForeName': 'Geovana', 'Initials': 'G', 'LastName': 'Martin-Alemañy', 'Affiliation': 'Departamento de Nefrología, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico.'}, {'ForeName': 'María de Los Ángeles', 'Initials': 'MLÁ', 'LastName': 'Espinosa-Cuevas', 'Affiliation': 'Departamento de Nefrología y Metabolismo Mineral, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Monserrat', 'Initials': 'M', 'LastName': 'Pérez-Navarro', 'Affiliation': 'Departamento de Nefrología, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Wilund', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois; Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Miranda-Alatriste', 'Affiliation': 'Departamento de Nefrología y Metabolismo Mineral, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortés-Pérez', 'Affiliation': 'Departamento de Nefrología, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'García-Villalobos', 'Affiliation': 'Departamento de Nefrología, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Gómez-Guerrero', 'Affiliation': 'Departamento de Nefrología, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Cantú-Quintanilla', 'Affiliation': 'Facultad de Medicina, Universidad Panamericana, Mexico City, Mexico.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Ramírez-Mendoza', 'Affiliation': 'Departamento de Cardiología, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Valdez-Ortiz', 'Affiliation': 'Departamento de Nefrología, Hospital General de México ""Dr. Eduardo Liceaga"", Mexico City, Mexico. Electronic address: rafavaldez@gmail.com.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.06.010']
3221,31984668,The WORD: Outcomes of a Behavioral Weight Loss Maintenance Effectiveness Trial in Rural Black Adults of Faith.,"OBJECTIVE


Rural black communities bear a disproportionate burden of obesity. To increase reach among underserved groups, community-based weight loss and maintenance interventions are crucial.
METHODS


The Diabetes Prevention Program (DPP) was adapted for rural black adults of faith to create The Wholeness, Oneness, Righteousness, Deliverance (WORD) trial, a group-based, community health worker-delivered weight loss intervention. A Weight Loss Only arm (16 sessions) was compared with a Weight Loss + Maintenance arm (16 + 12 sessions) in a cluster randomized controlled trial of 31 churches (n = 440). Weight and related behaviors were assessed at 0, 6, 12, and 18 months.
RESULTS


The WORD produced weight loss from baseline to 6 months (percentage body weight change -2.47 [-3.13 to -1.80]). Among those who lost 5% of their baseline weight, there was a statistical trend of lower weight regain in the Weight Loss + Maintenance arm compared with control. Maintenance arm participants reported higher activity at 12 months. There were no between-arm differences at 18 months.
CONCLUSIONS


The WORD produced weight loss from baseline to 6 months on par with that produced by other DPP adaptations for black communities, including adaptations using health professionals. Weight regain was also consistent with that reported in prior literature. Continuing sessions as part of the church's mission may foster adoption of DPP-based weight loss programs.",2020,"There were no between-arm differences at 18 months.
","['rural black adults of faith to create The Wholeness, Oneness, Righteousness, Deliverance (WORD) trial, a group-based, community health worker-delivered weight loss intervention', 'Rural Black Adults of Faith', 'Rural black communities bear a disproportionate burden of obesity']","['Diabetes Prevention Program (DPP', 'Behavioral Weight']","['Weight and related behaviors', 'WORD produced weight loss', 'weight regain', 'Weight regain']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205350', 'cui_str': 'Disproportionate (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0311129,"There were no between-arm differences at 18 months.
","[{'ForeName': 'Karen H Kim', 'Initials': 'KHK', 'LastName': 'Yeary', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Cornell', 'Affiliation': 'Health Education and Health Behavior Department, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Page C', 'Initials': 'PC', 'LastName': 'Moore', 'Affiliation': 'Corrona, LLC, Washington, D.C., USA.'}, {'ForeName': 'C Heath', 'Initials': 'CH', 'LastName': 'Gauss', 'Affiliation': 'Health Education and Health Behavior Department, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'T Elaine', 'Initials': 'TE', 'LastName': 'Prewitt', 'Affiliation': 'Health Education and Health Behavior Department, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Boys, Girls, Adults Community Development Center, Marvell, Arkansas, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22717']
3222,31464511,"A Randomized, Double-Blind, Placebo-Controlled Study of HLD200, a Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder: An Evaluation of Safety and Efficacy Throughout the Day and Across Settings.","Objectives:  HLD200, a once-daily, evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH), was designed to provide therapeutic effect beginning upon awakening and lasting into the evening. This pivotal, randomized, double-blind, multicenter, placebo-controlled, phase 3 trial assessed improvements in functional impairment across the day using multiple validated measures tailored for different settings and time of day in children (6-12 years) with attention-deficit/hyperactivity disorder (ADHD).  Methods:  Following a 6-week, open-label titration of DR/ER-MPH to an optimal dose (20, 40, 60, 80, or 100 mg/day) and dosing time (8:00 PM ±1.5 hours), participants were randomized to treatment-optimized DR/ER-MPH or placebo for 1 week. The primary endpoint was the model-adjusted average of postdose Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale combined scores (SKAMP CS) over a 12-hour laboratory classroom day (8:00 AM to 8:00 PM). The key secondary endpoint was the Parent Rating of Evening and Morning Behavior-Revised, Morning (PREMB-R AM) subscale. Secondary/exploratory measures included the PREMB-R Evening (PREMB-R PM) subscale and Permanent Product Measure of Performance (Attempted [PERMP-A] and Correct [PERMP-C]). Safety endpoints included treatment-emergent adverse events (TEAEs).  Results:  After the treatment-optimization phase, the mean optimized dose was 66.2 mg and the most common prescribed dosing time was 8:00 PM. Double-blind DR/ER-MPH treatment significantly improved functional impairment versus placebo in the early morning (PREMB-R AM:  p  < 0.001), averaged over the classroom day (SKAMP CS:  p  < 0.001), and in the late afternoon/evening (PREMB-R PM:  p  = 0.003) in the intent-to-treat population ( N  = 117). Average PERMP-A ( p  = 0.006) and PERMP-C ( p  = 0.009) also indicated improved classroom performance with DR/ER-MPH versus placebo. In the double-blind phase, TEAEs did not differ between DR/ER-MPH and placebo groups and no serious TEAEs or TEAEs leading to discontinuation were reported.  Conclusion:  DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day across different settings in children with ADHD.",2020,DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day across different settings in children with ADHD.,"['children (6-12 years) with attention-deficit/hyperactivity disorder (ADHD', 'Children with Attention-Deficit/Hyperactivity Disorder', 'children with ADHD']","['HLD200, a Delayed-Release and Extended-Release Methylphenidate', 'treatment-optimized DR/ER-MPH or placebo', 'placebo', 'HLD200, a once-daily, evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH', 'Placebo']","['classroom performance', 'treatment-emergent adverse events (TEAEs', 'Parent Rating of Evening and Morning Behavior-Revised, Morning (PREMB-R AM) subscale', 'model-adjusted average of postdose Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale combined scores (SKAMP CS', 'functional impairment', 'Safety and Efficacy', 'PREMB-R Evening (PREMB-R PM) subscale and Permanent Product Measure of Performance (Attempted [PERMP-A] and Correct [PERMP-C']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C4544674', 'cui_str': 'Delayed-release'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0222045'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",,0.477939,DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day across different settings in children with ADHD.,"[{'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cutler', 'Affiliation': 'Meridien Research, Bradenton, Florida.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marraffino', 'Affiliation': 'Meridien Research, Maitland, Florida.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'McDonnell', 'Affiliation': 'South Shore Psychiatric Services, Hingham, Massachusetts.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Turnbow', 'Affiliation': 'Westex Clinical Investigations, Lubbock, Texas.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brams', 'Affiliation': 'Bayou City Research, Ltd., Houston, Texas.'}, {'ForeName': 'Norberto J', 'Initials': 'NJ', 'LastName': 'DeSousa', 'Affiliation': 'Ironshore Pharmaceuticals & Development, Inc., Camana Bay, Grand Cayman, Cayman Islands.'}, {'ForeName': 'Bev', 'Initials': 'B', 'LastName': 'Incledon', 'Affiliation': 'Ironshore Pharmaceuticals & Development, Inc., Camana Bay, Grand Cayman, Cayman Islands.'}, {'ForeName': 'Floyd R', 'Initials': 'FR', 'LastName': 'Sallee', 'Affiliation': 'Ironshore Pharmaceuticals Inc., Durham, North Carolina.'}, {'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Wigal', 'Affiliation': 'AVIDA, Inc., Newport Beach, California.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0070']
3223,31398593,Feasibility and clinical effects of theta burst stimulation in youth with major depressive disorders: An open-label trial.,"BACKGROUND


Conventional treatments for youth depression, such as antidepressants, have modest efficacy, side effects, and ongoing controversies regarding safety. Repetitive transcranial magnetic stimulation (rTMS), specifically theta burst stimulation (TBS), applied to the dorsolateral prefrontal cortex (DLPFC) has demonstrated efficacy for the treatment of depression in adults. However, the feasibility and clinical response to TBS for youth depression has yet to be explored.
METHODS


Twenty participants between the ages of 16 to 24 years old with MDD were recruited. The intervention consisted of 10 treatment sessions over the course of two weeks, in which participants received intermittent TBS and continuous TBS stimulation to the left and right DLPFC, respectively. Change in the Hamilton Rating Scale for Depression (HRSD-17) score was the primary outcome. Clinical assessments occurred at baseline, after the fifth treatment session, and within a week after treatment completion.
RESULTS


Of the twenty participants, eighteen received all TBS sessions, and seventeen completed all clinical assessments. There was a significant reduction in depressive symptoms following treatment completion (p < 0.001). Four of the twenty patients had more than 50% reduction in their depressive symptoms, two of whom achieved remission. All participants received and tolerated at least six daily TBS treatments with no major adverse events.
LIMITATIONS


Study was an uncontrolled, open-label design.
CONCLUSION


Ten sessions of TBS was feasible, well tolerated, and appeared to have clinical effects for the treatment of depressed youth. Future sham-controlled randomized trials are warranted to validate these findings in a larger cohort of youth depression.",2019,There was a significant reduction in depressive symptoms following treatment completion (p < 0.001).,"['Twenty participants between the ages of 16 to 24 years old with MDD were recruited', 'youth with major depressive disorders', 'adults', 'twenty participants']","['intermittent TBS and continuous TBS stimulation', 'TBS', 'Repetitive transcranial magnetic stimulation (rTMS), specifically theta burst stimulation (TBS', 'theta burst stimulation']","['Hamilton Rating Scale for Depression (HRSD-17) score', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",20.0,0.0452684,There was a significant reduction in depressive symptoms following treatment completion (p < 0.001).,"[{'ForeName': 'Prabhjot', 'Initials': 'P', 'LastName': 'Dhami', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada.'}, {'ForeName': 'Sravya', 'Initials': 'S', 'LastName': 'Atluri', 'Affiliation': 'Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Institute of Biomaterial and Biomedical Engineering, Rosebrugh Building, Room 407, 164 College St, Toronto, Ontario, M5S 3G9, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Darren B', 'Initials': 'DB', 'LastName': 'Courtney', 'Affiliation': 'Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Croarkin', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Farzan', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada; School of Mechatronic Systems Engineering, Simon Fraser University, 250-13450 102 Avenue, Surrey, British Columbia, V3T 0A3, Canada. Electronic address: ffarzan@sfu.ca.""}]",Journal of affective disorders,['10.1016/j.jad.2019.07.084']
3224,31809394,"Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study.","BACKGROUND


Bone-graft substitutes are commonly used for the augmentation of traumatic bone defects in tibial plateau fractures. However, their clinical performance compared with that of autologous bone-grafting, the gold standard in bone defect reconstruction, still remains under debate. This study investigates the differences in quality of life, pain, and radiographic outcomes in the treatment of tibial plateau fracture-associated bone defects with either autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT).
METHODS


In this study, 135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3) were enrolled in a prospective, controlled, randomized, multicenter trial including 20 hospitals in Germany. Patients were randomized to receive either autologous iliac bone graft or CBVF for reconstruction of the bone defect. The primary outcome measures were the Short Form (SF)-12 version 2 Physical Component Summary (PCS) score at week 26 (the study was designed to show noninferiority of the CBVF with regard to the PCS with a prespecified margin of -5 points) and the pain level at 26 weeks postoperatively measured by a visual analog scale (VAS). The secondary outcomes were the SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs.
RESULTS


Age, sex, fixation methods, and fracture pattern were comparable in both groups. There were no significant differences (p > 0.05) in the SF-12 PCS or VAS scores at postoperative week 26. There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group. The rates of fracture-healing, defect remodeling, and articular subsidence were not significantly different (p > 0.05) in both groups.
CONCLUSIONS


Bioresorbable CBVF was noninferior to autologous bone graft with regard to both patient-reported and radiographic outcomes in tibial plateau fractures of OTA/AO types 41-B2 and 41-B3.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group.,"['tibial plateau fractures', '135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3', '20 hospitals in Germany', 'Tibial Plateau Fractures']","['Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement', 'autologous bone-grafting', 'autologous iliac bone graft or CBVF', 'autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT']","['rates of fracture-healing, defect remodeling, and articular subsidence', 'SF-12 PCS or VAS scores', 'Bone Defects', 'pain level', 'quality of life, pain, and radiographic outcomes', 'Short Form (SF)-12 version 2 Physical Component Summary (PCS) score', 'SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs', 'visual analog scale (VAS', 'blood loss', 'pain levels']","[{'cui': 'C0584640', 'cui_str': 'Tibial plateau structure (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1386135', 'cui_str': 'Acute depression'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C3658778', 'cui_str': 'cerament'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}]","[{'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",135.0,0.067637,There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hofmann', 'Affiliation': 'Department of Traumatology and Orthopaedics 1, Academic Teaching Hospital of the Universities Mainz and Heidelberg, Westpfalz-Clinics, Kaiserslautern, Germany.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Gorbulev', 'Affiliation': 'Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center, Mainz, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Guehring', 'Affiliation': 'Department for Traumatology and Orthopaedic Surgery, BG Traumacenter Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Arndt Peter', 'Initials': 'AP', 'LastName': 'Schulz', 'Affiliation': 'Department of Traumatology, Orthopaedics and Sports Traumatology, BG Trauma Hospital, Hamburg, Germany.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Schupfner', 'Affiliation': 'Department of Trauma Surgery, Clinical Center Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Raschke', 'Affiliation': 'Department of Trauma Surgery, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Huber-Wagner', 'Affiliation': 'Department of Trauma Surgery, University of Munich, Munich, Germany.'}, {'ForeName': 'Pol Maria', 'Initials': 'PM', 'LastName': 'Rommens', 'Affiliation': 'Department of Orthopedics and Traumatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00680']
3225,31273908,'We're all in the same boat': A qualitative study on how groups work in a diabetes prevention and management programme.,"OBJECTIVES


Although many health interventions are delivered in groups, it is unclear how group context can be best used to promote health-related behaviour change and what change processes are most helpful to participants. This study explored participants' experiences of attending type 2 diabetes prevention and management programme, and their perceptions of how group participation influenced changes in diet and physical activity.
DESIGN


Qualitative.
METHODS


Semi-structured telephone interviews were conducted with 20 participants (twelve men) from nine groups in the Norfolk Diabetes Prevention Study. Interviews were audio-recorded, transcribed verbatim, and analysed using thematic analysis in NVivo.
RESULTS


Participants benefited from individual change processes, including information provision, structuring and prioritizing health goals, action planning, self-monitoring, and receiving feedback. They also benefited from group processes, including having a common purpose, sharing experiences, making social comparisons, monitoring and accountability, and providing and receiving social support in the groups. Participants' engagement with, and benefits from, the groups were enhanced when there was a supportive group context (i.e., group cohesion, homogeneous group composition, and a positive group atmosphere). Optimal facilitation to develop an appropriate group context and initiate effective change processes necessitated good facilitator interpersonal and professional skills, credibility and empathy, and effective group facilitation methods. Participants reported developing a sense of responsibility and making behaviour changes that resulted in improvements in health outcomes and weight loss.
CONCLUSIONS


This study highlights the role of individual and group processes in facilitating health-promoting behaviour change, and the importance of group context and optimal facilitation in promoting engagement with the programme. Statement of contribution What is already known on this subject? Many health interventions, including programmes to help prevent or manage diabetes and facilitate weight loss, are delivered in groups. Such group-based behaviour-change interventions are often effective in facilitating psychological and behaviour change. There is considerable research and theory on individual change processes and techniques, but less is known about which change processes and techniques facilitate behaviour change in group settings. What does this study add? This study contributes to our understanding of how participating in group-based health programmes may enhance or impede individual behaviour change. It identified individual (intrapersonal) and group (interpersonal, facilitated through group interaction) change processes that were valued by group participants. The findings also show how these change processes may be affected by the group context. A diagram summarizes the identified themes helping to understand interactions between these key processes occurring in groups. The study offers an insight into participants' views on, and experiences of, attending a group-based diabetes prevention and management programme. Thus, it helps better understand how the intervention might have helped them (or not) and what processes may have influenced intervention outcomes. Key practical recommendations for designing and delivering group-based behaviour-change interventions are presented, which may be used to improve future group-based health interventions.",2019,This study contributes to our understanding of how participating in group-based health programmes may enhance or impede individual behaviour change.,"[""participants' experiences of attending type 2 diabetes prevention and management programme"", 'Semi-structured telephone interviews were conducted with 20 participants (twelve men) from nine groups in the Norfolk Diabetes Prevention Study', ""participants' views on, and experiences of, attending a group-based diabetes prevention and management programme""]",[],"['health outcomes and weight loss', 'information provision, structuring and prioritizing health goals, action planning, self-monitoring, and receiving feedback']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0454866', 'cui_str': 'Norfolk (geographic location)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",20.0,0.0187808,This study contributes to our understanding of how participating in group-based health programmes may enhance or impede individual behaviour change.,"[{'ForeName': 'Aleksandra J', 'Initials': 'AJ', 'LastName': 'Borek', 'Affiliation': 'University of Exeter Medical School, University of Exeter, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'University of Exeter Medical School, University of Exeter, UK.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Greaves', 'Affiliation': 'University of Exeter Medical School, University of Exeter, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tarrant', 'Affiliation': 'University of Exeter Medical School, University of Exeter, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Garner', 'Affiliation': 'Norfolk Diabetes Prevention Study, Norfolk & Norwich University Foundation Healthcare Trust, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pascale', 'Affiliation': 'Norfolk Diabetes Prevention Study, Norfolk & Norwich University Foundation Healthcare Trust, UK.'}]",British journal of health psychology,['10.1111/bjhp.12379']
3226,30095230,"The Feasibility and Effectiveness of PASS Plus, A Lay Health Worker Delivered Comprehensive Intervention for Autism Spectrum Disorders: Pilot RCT in a Rural Low and Middle Income Country Setting.","The treatment gap for autism globally is high. Our previous PASS intervention, delivered by community based lay health workers, showed effectiveness. This article reports the development and evaluation of a new ""PASS 'Plus'"" intervention in a rural population in India. Using formative research methods, we supplemented the PASS intervention with additional (Plus) modules to address autism comorbidities. This is the first time that a rigorous methodology has been used to evaluate autism symptom outcomes in a low and middle-income country setting. 40 parent-child dyads were recruited in a pilot randomized controlled trial against usual care (mean age 65 months (34 boys); n = 19 PASS Plus, n = 21 UC). 89% of intervention families partially or entirely completed the 12-session intervention. Intention to treat analysis showed a reduction in mean scores of autism symptom severity, though the confidence interval contains zero, (adjusted mean difference AMD -2.42 95% CI -7.75, 2.92; ES 0.22); large treatment effects on proximal outcomes of proportion of parent synchronous responses (AMD 0.35; 95% CI 0.18, 0.52; effect size ES 3.97) and proportion of child communication initiations with parent (AMD 0·17; 95% CI 0.03, 0.32; ES 1.02). Confidence intervals for effects on mutual shared attention (AMD 0.10; 95% CI -0.07, 0.27; ES 0.5) and co-morbid symptoms (AMD -9.0; 95% CI -24.26, 6.26; ES 0.32) contained zero. There were significant effects to improve parental mental health. PASS Plus shows good feasibility and adds to the evidence of the effectiveness of task sharing complex autism interventions to lay health workers in India. Autism Res 2019, 12: 328-339 © 2018 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: This article describes the development of a comprehensive, community-delivered, intervention for young children with autism, which combines a previously developed parent-mediated communication intervention with support for co-morbid problems like challenging behaviors and sensory sensitivities. The unique aspect of this intervention is that it can be delivered by community health workers, addressing the lack of specialists in low resource settings. Our study reports the encouraging findings of a pilot trial evaluating its feasibility and effectiveness.",2019,PASS Plus shows good feasibility and adds to the evidence of the effectiveness of task sharing complex autism interventions to lay health workers in India.,"['rural population in India', 'Autism Res 2019, 12: 328-339 © 2018 International Society for Autism Research, Wiley Periodicals, Inc', 'Rural Low and Middle Income Country Setting', 'Autism Spectrum Disorders', '40 parent-child dyads', 'young children with autism']","['PASS intervention with additional (Plus) modules', 'PASS Plus', 'AMD', 'new ""PASS \'Plus\'"" intervention']","['mean scores of autism symptom severity', 'proximal outcomes of proportion of parent synchronous responses', 'proportion of child communication initiations', 'parental mental health']","[{'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0035168'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0966323,PASS Plus shows good feasibility and adds to the evidence of the effectiveness of task sharing complex autism interventions to lay health workers in India.,"[{'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, 451 (168) Bhaktar Waddo Succor Bardez, Goa, 403501, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Vajaratkar', 'Affiliation': 'Sangath, 451 (168) Bhaktar Waddo Succor Bardez, Goa, 403501, India.'}, {'ForeName': 'Percy', 'Initials': 'P', 'LastName': 'Cardozo', 'Affiliation': 'Sangath, 451 (168) Bhaktar Waddo Succor Bardez, Goa, 403501, India.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Huzurbazar', 'Affiliation': 'Sanwad 318-C, Bhende Galli, Shivaji Chowk, Kolhapur, Maharashtra, India.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Verma', 'Affiliation': 'Sangath, 451 (168) Bhaktar Waddo Succor Bardez, Goa, 403501, India.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Howarth', 'Affiliation': 'Centre for Biostatistics, School of Health of Sciences, The University of Manchester, Manchester Academic Health Science Centre, 1.317 Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': 'Centre for Biostatistics, School of Health of Sciences, The University of Manchester, Manchester Academic Health Science Centre, 1.317 Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'University of Manchester, Institute of Brain, Behaviour and Mental Health, 3rd Floor Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Harvard Medical School, Boston; Sangath, Bhaktar Waddo Succor Bardez, Goa, 403501, India.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Centre for Biostatistics, School of Health of Sciences, The University of Manchester, Manchester Academic Health Science Centre, 1.317 Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.1978']
3227,28327907,"A randomized, open-label, phase 2 study of everolimus in combination with pasireotide LAR or everolimus alone in advanced, well-differentiated, progressive pancreatic neuroendocrine tumors: COOPERATE-2 trial.","Background


Several studies have demonstrated the antitumor activity of first-generation somatostatin analogs (SSAs), primarily targeting somatostatin receptor (sstr) subtypes 2 and 5, in neuroendocrine tumors (NET). Pasireotide, a second-generation SSA, targets multiple sstr subtypes. We compared the efficacy and safety of pasireotide plus everolimus to everolimus alone in patients with advanced, well-differentiated, progressive pancreatic NET.
Patients and methods


Patients were randomized 1 : 1 to receive a combination of everolimus (10 mg/day, orally) and pasireotide long-acting release (60 mg/28 days, intramuscularly) or everolimus alone (10 mg/day, orally); stratified by prior SSA use, and baseline serum chromogranin A and neuron-specific enolase. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, objective response rate, disease control rate, and safety. Biomarker response was evaluated in an exploratory analysis.
Results


Of 160 patients enrolled, 79 were randomized to the combination arm and 81 to the everolimus arm. Baseline demographics and disease characteristics were similar between the treatment arms. No significant difference was observed in PFS: 16.8 months in combination arm versus 16.6 months in everolimus arm (hazard ratio, 0.99; 95% confidence interval, 0.64-1.54). Partial responses were observed in 20.3% versus 6.2% of patients in combination arm versus everolimus arm; however, overall disease control rate was similar (77.2% versus 82.7%, respectively). No significant improvement was observed in median overall survival. Adverse events were consistent with the known safety profile of both the drugs; grade 3 or 4 fasting hyperglycemia was seen in 37% versus 11% of patients, respectively.
Conclusions


The addition of pasireotide to everolimus was not associated with the improvement in PFS compared with everolimus alone in this study. Further studies to delineate mechanisms by which SSAs slow tumor growth in NET are warranted.",2017,The addition of pasireotide to everolimus was not associated with the improvement in PFS compared with everolimus alone in this study.,"['160 patients enrolled', 'patients with advanced, well-differentiated, progressive pancreatic NET', 'in advanced, well-differentiated, progressive pancreatic neuroendocrine tumors']","['everolimus alone', 'everolimus', 'combination of everolimus', 'everolimus in combination with pasireotide LAR or everolimus alone', 'pasireotide plus everolimus']","['progression-free survival (PFS', 'Adverse events', 'PFS', 'Partial responses', 'Baseline demographics and disease characteristics', 'overall disease control rate', 'overall survival, objective response rate, disease control rate, and safety', 'median overall survival', 'fasting hyperglycemia', 'efficacy and safety', 'Biomarker response']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0242363', 'cui_str': 'Islet Cell Tumor'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",160.0,0.143503,The addition of pasireotide to everolimus was not associated with the improvement in PFS compared with everolimus alone in this study.,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Kulke', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ruszniewski', 'Affiliation': 'Department of Gastroenterology and Pancreatology University of Paris VII and Beaujon Hospital, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Digestive Oncology, University Hospitals Gasthuisberg/Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard-Bohas', 'Affiliation': 'Department of Medical Oncology, Edouard Herriot Hospital, Lyon, France.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Department of Medical Oncology, University of Manchester/The Christie Hospital, Manchester, UK.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'De Herder', 'Affiliation': 'Department of Endocrine Oncology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': 'Department of Hepatology and Gastroenterology, Charité University of Medicine, Berlin, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Degtyarev', 'Affiliation': 'Department of Oncology, Novartis AG, Basel, Switzerland.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Department of Oncology, Novartis AG, Basel, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bubuteishvili-Pacaud', 'Affiliation': 'Department of Oncology, Novartis AG, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voi', 'Affiliation': 'Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salazar', 'Affiliation': 'Department of Medical Oncology, Catalan Institute of Oncology, IDIBELL, Hospital of Barcelona, Barcelona, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'Department of Gastroenterology Saint-Luc University Hospital, Brussels, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Fazio', 'Affiliation': 'Department of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Oncology, St. Andrew Hospital, Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Riechelmann', 'Affiliation': 'Department of Oncology, Cancer Institute of the State of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Yao', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx078']
3228,32112166,A Comparison of Intrathecal and Intravenous Morphine for Analgesia After Hepatectomy: A Randomized Controlled Trial.,"BACKGROUND


Effective analgesia is essential for patient recovery after liver resection. This study aimed to evaluate the effects of the addition of preoperative intrathecal morphine to multimodal intravenous analgesia in patients undergoing liver resection.
METHODS


In this single-blind randomized controlled trial, patients undergoing liver resection were randomly assigned to the patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine groups. All patients received acetaminophen and dexketoprofen. The primary outcome was pain severity at rest over three postoperative days, assessed using the numerical rating scale (NRS).
RESULTS


The study included 36 patients (18 in each group). The mean maximum daily NRS scores over the first three postoperative days in the ITM-IV and IV groups were 1.3, 1.1, and 0.3 and 1.6, 1.1, and 0.7, respectively (p = 0.580). No differences were observed in pain severity while coughing, with corresponding scores of 2.8, 2.1, and 1.1, respectively, in the ITM-IV group and 2.3, 2.2, and 1.5, respectively, in the IV group (p = 0.963). Proportions of patients reporting clinically significant pain at rest and while coughing were 11.1% and 44.4%, respectively, in the ITM-IV group, and 16.7% and 44.4%, respectively, in the IV group (both p > 0.999). Cumulative morphine doses in the ITM-IV and IV groups were 26 mg and 17 mg, respectively (p = 0.257). Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
CONCLUSIONS


Preoperative intrathecal morphine administration provides no benefits to multimodal analgesia in patients undergoing liver resection.
TRIAL REGISTRATION NUMBER


Clinicaltrial.gov Identifier: NCT03620916.",2020,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","['patients undergoing liver resection', 'patient recovery after liver resection', '36 patients (18 in each group']","['patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine', 'acetaminophen and dexketoprofen', 'morphine', 'Intrathecal and Intravenous Morphine', 'preoperative intrathecal morphine']","['pain severity while coughing', 'sedation grade', 'pain severity', 'time to mobilization', 'solid food intake', 'mean maximum daily NRS scores', 'morbidity', 'pain at rest and while coughing', 'Analgesia', 'numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0453855', 'cui_str': 'Solid food (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0222045'}]",36.0,0.200098,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Niewiński', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Figiel', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland. w.figiel@yahoo.es.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Dec', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Morawski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}]",World journal of surgery,['10.1007/s00268-020-05437-x']
3229,32090922,Comparing the fracture limits of the proximal femur under impact and quasi-static conditions in simulation of a sideways fall.,"Sideways falls onto the hip are responsible for a great number of fractures in older adults. One of the possible ways to prevent these fractures is through early identification of people at greatest risk so that preventive measures can be properly implemented. Many numerical techniques that are designed to predict the femur fracture risk are validated through performing quasi-static (QS) mechanical tests on isolated cadaveric femurs, whereas the real hip fracture is a result of an impact (IM) incident. The goal of this study was to compare the fracture limits of the proximal femur under IM and QS conditions in the simulation of a sideways fall to identify any possible relationship between them. Eight pairs of fresh frozen cadaveric femurs were divided into two groups of QS and IM (left and right randomized). All femurs were scanned with a Hologic DXA scanner and then cut and potted in a cylindrical tube. To measure the stiffness in two conditions of the single-leg stance (SLS) and sideways fall (SWF), non-destructive tests at a QS displacement rate were performed on the two groups. For the destructive tests, the QS group was tested in SWF configuration with the rate of 0.017 mm/s using a material testing machine, and the IM group was tested in the same configuration inside a pneumatic IM device with the projectile target displacement rate of 3 m/s. One of the IM specimens was excluded due to multiple strikes. The result of this study showed that there were no significant differences in the SLS and SWF stiffnesses between the two groups (P = 0.15 and P = 0.64, respectively). The destructive test results indicated that there was a significant difference in the fracture loads of the two groups (P < 0.00001) with the impact ones being higher; however, they were moderately correlated (R 2  = 0.45). Also, the comparison of the fracture location showed a qualitatively good agreement between the two groups. Using the relationship developed herein, results from another study were extrapolated with errors of less than 12%, showing that meaningful predictions for the impact scenario can be made based on the quasi-static tests. The result of this study suggests that there is a potential to replace IM tests with QS displacement rate tests, and this will provide important information that can be used for future studies evaluating clinical factors related to fracture risk.",2020,"The destructive test results indicated that there was a significant difference in the fracture loads of the two groups (P < 0.00001) with the impact ones being higher; however, they were moderately correlated (R 2  = 0.45).","['older adults', 'Eight pairs of fresh frozen cadaveric femurs']",['Hologic DXA scanner'],"['SLS and SWF stiffnesses', 'fracture limits', 'single-leg stance (SLS) and sideways fall (SWF), non-destructive tests at a QS displacement rate', 'fracture loads']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]","[{'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0233520', 'cui_str': 'Destructive behavior (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}]",,0.0190123,"The destructive test results indicated that there was a significant difference in the fracture loads of the two groups (P < 0.00001) with the impact ones being higher; however, they were moderately correlated (R 2  = 0.45).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jazinizadeh', 'Affiliation': 'Department of Mechanical Engineering, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Hojjat', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Civil Engineering, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Cheryl E', 'Initials': 'CE', 'LastName': 'Quenneville', 'Affiliation': 'Department of Mechanical Engineering, McMaster University, Hamilton, ON, Canada; School of Biomedical Engineering, McMaster University, Hamilton, ON, Canada. Electronic address: quennev@mcmaster.ca.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.103593']
3230,32090932,The effect of heat treatment and surface neutralization on bond strength of orthodontic brackets to lithium disilicate glass-ceramic.,"PURPOSE


The study evaluated and compared the effect of pre-etching heat treatment and post-etching surface neutralization on the surface texture parameters and initial adhesion strength of orthodontic brackets bonded to lithium disilicate glass-ceramic using water-based and resin-based cement.
MATERIALS AND METHODS


A total of 120 samples were fabricated by duplicating the buccal surface of the maxillary premolar. The samples were randomly assigned to two groups: the cementing surface of group 1 samples was heat-treated, and that of group 2 samples was left untreated. The samples of each group were further divided into 4 subgroups (n = 15) according to the use of neutralization and the type of cement used for bonding. The surface texture parameters after etching were determined using a non-contact surface profilometer, and the bond strength was determined by a universal material tester. The results were analyzed by analysis of variance and the Scheffe post hoc test.
RESULTS


The samples that were heat-treated showed statistically significant higher bond strength in all the subgroups, and the acid-neutralized samples showed higher bond strength using both types of cement; however, the increase was statistically significant only in resin-based cement-bonded samples. Resin-based cement-bonded samples showed higher bond strength than water-based cement-bonded samples.
CONCLUSION


Pre-etching heat treatment and post-etching acid neutralization of the cementing surface of lithium disilicate glass-ceramic significantly improve the surface texture and initial bond strength to orthodontic brackets.",2020,"The samples that were heat-treated showed statistically significant higher bond strength in all the subgroups, and the acid-neutralized samples showed higher bond strength using both types of cement; however, the increase was statistically significant only in resin-based cement-bonded samples.","['orthodontic brackets to lithium disilicate glass-ceramic', 'orthodontic brackets bonded to lithium disilicate glass-ceramic using water-based and resin-based cement']",['pre-etching heat treatment and post-etching surface neutralization'],"['surface texture and initial bond strength', 'bond strength']","[{'cui': 'C0085428', 'cui_str': 'Dental Braces'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C1618088', 'cui_str': 'Glass ceramics'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1704479', 'cui_str': 'Cement'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}]",120.0,0.0237821,"The samples that were heat-treated showed statistically significant higher bond strength in all the subgroups, and the acid-neutralized samples showed higher bond strength using both types of cement; however, the increase was statistically significant only in resin-based cement-bonded samples.","[{'ForeName': 'Samer M', 'Initials': 'SM', 'LastName': 'Alaqeel', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh, 11433, Saudi Arabia. Electronic address: samirmalaqeel@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.103605']
3231,32093557,Passive Peritoneal Drainage Impact on Fluid Balance and Inflammatory Mediators: A Randomized Pilot Study.,"BACKGROUND


Infants after cardiopulmonary bypass are exposed to increasing inflammatory mediator release and are at risk of developing fluid overload. The aim of this pilot study was to evaluate the impact of passive peritoneal drainage on achieving negative fluid balance and its ability to dispose of inflammatory cytokines.
METHODS


From September 2014 to November 2016, infants undergoing STAT category 3, 4, and 5 operations were randomized to receive or not receive intraoperative prophylactic peritoneal drain. We analyzed time to negative fluid balance and perioperative variables for each group. Pro- and anti-inflammatory cytokines were measured from serum and peritoneal fluid in the passive peritoneal drainage group and serum in the control group postoperatively.
RESULTS


Infants were randomized to prophylactic passive peritoneal drain group (n = 13) and control (n = 12). The groups were not significantly different in pre- and postoperative peak lactate levels, postoperative length of stay, and mortality. Peritoneal drain patients reached time to negative fluid balance at a median of 1.42 days (interquartile range [IQR]: 1.00-2.91), whereas the control at 3.08 (IQR: 1.67-3.88;  P  = .043). Peritoneal drain patients had lower diuretic index at 72 hours, median of 2.86 (IQR: 1.21-4.94) versus 6.27 (IQR: 4.75-11.11;  P  = .006). Consistently, tumor necrosis factor-α, interleukin (IL)-4, IL-6, IL-8, IL-10, and interferon-γ were present at higher levels in peritoneal fluid than serum at 24 and 72 hours. However, serum cytokine levels in peritoneal drain and control group, at 24 and 72 hours postoperatively, did not differ significantly.
CONCLUSIONS


The prophylactic passive peritoneal drain patients reached negative fluid balance earlier and used less diuretic in early postoperative period. The serum cytokine levels did not differ significantly between groups at 24 and 72 hours postoperatively. However, there was no significant difference in mortality and postoperative length of stay.",2020,"However, serum cytokine levels in peritoneal drain and control group, at 24 and 72 hours postoperatively, did not differ significantly.
","['From September 2014 to November 2016, infants undergoing STAT category 3, 4, and 5 operations']","['intraoperative prophylactic peritoneal drain', 'Peritoneal drain', 'passive peritoneal drainage', 'prophylactic passive peritoneal drain']","['tumor necrosis factor-α, interleukin (IL)-4, IL-6, IL-8, IL-10, and interferon-γ', 'serum cytokine levels', 'mortality and postoperative length of stay', 'pre- and postoperative peak lactate levels, postoperative length of stay, and mortality', 'Fluid Balance and Inflammatory Mediators', 'diuretic index', 'time to negative fluid balance', 'Pro- and anti-inflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0489869', 'cui_str': 'Peritoneal drain'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]","[{'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0429652', 'cui_str': 'Negative fluid balance (finding)'}]",,0.0553485,"However, serum cytokine levels in peritoneal drain and control group, at 24 and 72 hours postoperatively, did not differ significantly.
","[{'ForeName': 'Kamal K', 'Initials': 'KK', 'LastName': 'Pourmoghadam', 'Affiliation': 'Section of Pediatric Cardiovascular Surgery, Arnold Palmer Hospital for Children, Orlando, FL, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Kubovec', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'DeCampli', 'Affiliation': 'Section of Pediatric Cardiovascular Surgery, Arnold Palmer Hospital for Children, Orlando, FL, USA.'}, {'ForeName': 'Bertha Ben', 'Initials': 'BB', 'LastName': 'Khallouq', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Piggott', 'Affiliation': 'Pediatric Cardiac Intensive Care, Orlando, FL, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Blanco', 'Affiliation': 'Pediatric Cardiac Intensive Care, Orlando, FL, USA.'}, {'ForeName': 'Harun', 'Initials': 'H', 'LastName': 'Fakioglu', 'Affiliation': 'Pediatric Cardiac Intensive Care, Orlando, FL, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Kube', 'Affiliation': 'Section of Pediatric Cardiovascular Surgery, Arnold Palmer Hospital for Children, Orlando, FL, USA.'}, {'ForeName': 'Sukumar Suguna', 'Initials': 'SS', 'LastName': 'Narasimhulu', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, FL, USA.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135119888143']
3232,31874879,Qualitative exploration of women's experiences of intramuscular pethidine or remifentanil patient-controlled analgesia for labour pain.,"OBJECTIVES


To explore women's experiences of remifentanil or pethidine for labour pain and infant feeding behaviours at 6weeks post partum.
DESIGN


Qualitative postnatal sub-study to the randomised controlled trial of remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour (RESPITE). Semistructured telephone interviews were conducted at 6 weeks post partum, and thematic analysis was undertaken.
SETTING


Women recruited to the RESPITE trial from seven UK hospitals.
PARTICIPANTS


Eighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview.
RESULTS


Eight themes emerged which encompassed women's antenatal plans for pain management ( Birth Expectations ) through to their future preferences for pain relief ( Reflections for Future Choices ). Many women who used remifentanil felt it provided effective pain relief ( Effectiveness of Pain Relief ), whereas women in the pethidine group expressed more mixed views. Both groups described side effects, with women using pethidine frequently reporting nausea ( Negative Physiological Responses ) and women using remifentanil describing more cognitive effects ( Cognitive Effects ). Some women who used remifentanil reported restricted movements due to technical aspects of drug administration and fear of analgesia running out ( Issues with Drug Administration ). Women described how remifentanil enabled them to maintain their ability to stay focused during the birth ( Enabling a Sense of Control ). There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ).
CONCLUSIONS


Qualitative insights from a follow-up study to a trial which explored experiences of intravenous remifentanil PCA with intramuscular pethidine injection found that remifentanil appeared to provide effective pain relief while allowing women to remain alert and focused during labour, although as with pethidine, some side effects were noted. Overall, there was little difference in reported breastfeeding initiation and duration between the two groups.
TRIAL REGISTRATION NUMBER


ISRCTN29654603.",2019,"There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ).
","[""women's experiences of intramuscular"", 'Eighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview', 'patient-controlled analgesia for labour pain', 'pain relief in labour (RESPITE', 'Women recruited to the RESPITE trial from seven UK hospitals']","['pethidine injection', 'remifentanil or pethidine', 'remifentanil', 'pethidine', 'remifentanil intravenous patient controlled analgesia (PCA', 'remifentanil PCA']","['effective pain relief', 'effective pain relief ( Effectiveness of Pain Relief ', 'Infant Behaviour and Breastfeeding ', 'nausea ( Negative Physiological Responses ', 'labour pain and infant feeding behaviours', 'side effects']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",80.0,0.0602575,"There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ).
","[{'ForeName': 'Victoria Hall', 'Initials': 'VH', 'LastName': 'Moran', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK VLMoran@uclan.ac.uk.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Storey', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Beeson', 'Affiliation': 'Birmingham Clinical Trials Unit, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'MacArthur', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Centre for Urgent and Emergency Care Research, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032203']
3233,31730370,Standardized Observation Analogue Procedure in the Treatment of Severe Childhood Aggression Study.,"Objective:  To explore blinded observational outcomes in the Treatment of Severe Childhood Aggression (TOSCA) study.  Methods:  During a 9-week acute trial, children with severe physical aggression and attention-deficit/hyperactivity disorder received parent training + titrated psychostimulant for 3 weeks, and those who failed to show an optimal response during Week 4 through Week 6 received in addition either randomly assigned placebo (Basic treatment) or titrated risperidone (Augmented treatment). Child and parent behaviors were videotaped in a Standardized Observation Analogue Procedure (SOAP) designed to elicit problems and strengths in child and parent interactions. SOAPs were collected at baseline and Week 9 and 52 follow-up.  Results:  During the acute 9-week trial, augmented treatment was associated with better outcomes than basic treatment for 3 of 13 measures: increased Child Compliance ( p  = 0.004; significant after correction for multiple tests), greater use of positive Parent Reinforcement ( p  = 0.03), and more Shared Enjoyment ( p  = 0.04). At follow-up, when medication was no longer by randomized assignment, parents used more Alpha Commands and displayed fewer Parent Negative Behaviors, and the dyads showed more Shared Enjoyment regardless of original randomization. Thus, there were better parent-child interactions with Augmented treatment, and interactions improved overall at follow-up regardless of original treatment assignment.  Conclusions:  The SOAP demonstrated sensitivity to behavior changes between short-term treatments for a few (but not most) measures. The acute treatment differences for Child Compliance and Child Negative Behavior are generally consistent with the moderate superiority of Augmented over Basic treatment previously reported for the primary study outcome.",2020,"During the acute 9-week trial, augmented treatment was associated with better outcomes than basic treatment for 3 of 13 measures: increased Child Compliance ( p  = 0.004; significant after correction for multiple tests), greater use of positive Parent Reinforcement ( p  = 0.03), and more Shared Enjoyment ( p  = 0.04).","['Severe Childhood Aggression (TOSCA) study', 'children with severe physical aggression and attention-deficit/hyperactivity disorder']","['placebo (Basic treatment) or titrated risperidone', 'parent training + titrated psychostimulant']","['SOAPs', 'sensitivity to behavior changes', 'Child Compliance', 'Child Compliance and Child Negative Behavior', 'greater use of positive Parent Reinforcement']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0856977', 'cui_str': 'Childhood aggression'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}]","[{'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}]",,0.076147,"During the acute 9-week trial, augmented treatment was associated with better outcomes than basic treatment for 3 of 13 measures: increased Child Compliance ( p  = 0.004; significant after correction for multiple tests), greater use of positive Parent Reinforcement ( p  = 0.03), and more Shared Enjoyment ( p  = 0.04).","[{'ForeName': 'Sabrina N', 'Initials': 'SN', 'LastName': 'Grondhuis', 'Affiliation': 'Department of Psychology and Neuroscience, Millsaps College, Jackson, Mississippi.'}, {'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Intermural Research Program, Department of Pediatrics and Developmental Neuroscience Branch, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Gadow', 'Affiliation': 'Department of Psychiatry, State University of New York, Stony Brook, New York.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': ""Division of Child & Adolescent Psychiatry, Bloomberg Children's Center, Baltimore, Maryland.""}, {'ForeName': 'Brooke S G', 'Initials': 'BSG', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry & Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'Department of Psychiatry & Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Buchan-Page', 'Affiliation': 'Nisonger Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Rice', 'Affiliation': 'Nisonger Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Butter', 'Affiliation': 'Nisonger Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Aman', 'Affiliation': 'Nisonger Center, The Ohio State University, Columbus, Ohio.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0109']
3234,31736357,Results of the FUEL Trial.,"BACKGROUND


The Fontan operation creates a total cavopulmonary connection, a circulation in which the importance of pulmonary vascular resistance is magnified. Over time, this circulation leads to deterioration of cardiovascular efficiency associated with a decline in exercise performance. Rigorous clinical trials aimed at improving physiology and guiding pharmacotherapy are lacking.
METHODS


The FUEL trial (Fontan Udenafil Exercise Longitudinal) was a phase III clinical trial conducted at 30 centers. Participants were randomly assigned udenafil, 87.5 mg twice daily, or placebo in a 1:1 ratio. The primary outcome was the between-group difference in change in oxygen consumption at peak exercise. Secondary outcomes included between-group differences in changes in submaximal exercise at the ventilatory anaerobic threshold, the myocardial performance index, the natural log of the reactive hyperemia index, and serum brain-type natriuretic peptide.
RESULTS


Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomly assigned 400 participants with Fontan physiology. The mean age at randomization was 15.5±2 years; 60% of participants were male, and 81% were white. All 400 participants were included in the primary analysis with imputation of the 26-week end point for 21 participants with missing data (11 randomly assigned to udenafil and 10 to placebo). Among randomly assigned participants, peak oxygen consumption increased by 44±245 mL/min (2.8%) in the udenafil group and declined by 3.7±228 mL/min (-0.2%) in the placebo group ( P =0.071). Analysis at ventilatory anaerobic threshold demonstrated improvements in the udenafil group versus the placebo group in oxygen consumption (+33±185 [3.2%] versus -9±193 [-0.9%] mL/min,  P =0.012), ventilatory equivalents of carbon dioxide (-0.8 versus -0.06,  P =0.014), and work rate (+3.8 versus +0.34 W,  P =0.021). There was no difference in change of myocardial performance index, the natural log of the reactive hyperemia index, or serum brain-type natriuretic peptide level.
CONCLUSIONS


In the FUEL trial, treatment with udenafil (87.5 mg twice daily) was not associated with an improvement in oxygen consumption at peak exercise but was associated with improvements in multiple measures of exercise performance at the ventilatory anaerobic threshold.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02741115.",2020,"Among randomized participants, peak oxygen consumption increased by 44 ±245 mL/min (2.8%) in the udenafil group and declined by 3.7 ±228 mL/min (-0.2%) in the placebo group (p=0.071).","['All 400 participants were included in the primary analysis with imputation of the 26-week endpoint for 21 participants with missing data (11 randomized to udenafil and 10 to', 'Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomized 400 participants with Fontan physiology', '30 centers', 'The mean age at randomization was 15.5 ±2 years; 60% of participants were male and 81% were White']","['placebo', 'Fontan Udenafil Exercise Longitudinal (FUEL', 'udenafil']","['oxygen consumption', 'changes in sub-maximal exercise at the ventilatory anaerobic threshold (VAT), the myocardial performance index (MPI), the natural log of the reactive hyperemia index (lnRHI), and serum brain-type natriuretic peptide (BNP', 'change in oxygen consumption at peak exercise', 'ventilatory equivalents of carbon dioxide', 'change of MPI, lnRHI, or serum BNP level', 'work rate', 'peak oxygen consumption']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0556991', 'cui_str': 'Fuel (substance)'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]",400.0,0.492881,"Among randomized participants, peak oxygen consumption increased by 44 ±245 mL/min (2.8%) in the udenafil group and declined by 3.7 ±228 mL/min (-0.2%) in the placebo group (p=0.071).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Goldberg', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Zak', 'Affiliation': 'New England Research Institutes, Watertown, MA (V.Z.).'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'Goldstein', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Kurt R', 'Initials': 'KR', 'LastName': 'Schumacher', 'Affiliation': ""Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rhodes', 'Affiliation': ""Department of Cardiology, Children's Hospital Boston, MA (J.R.).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Penny', 'Affiliation': ""Division of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX (D.J.P.).""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Petit', 'Affiliation': ""Emory University School of Medicine, Children's Healthcare of Atlanta, GA (C.J.P.).""}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Ginde', 'Affiliation': ""Division of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).""}, {'ForeName': 'Shaji C', 'Initials': 'SC', 'LastName': 'Menon', 'Affiliation': 'Division of Pediatric Cardiology, University of Utah, Salt Lake City (S.C.M.).'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Sejong General Hospital, Bucheon-Si, South Korea (S.-H.K.).'}, {'ForeName': 'Gi Beom', 'Initials': 'GB', 'LastName': 'Kim', 'Affiliation': ""Seoul National University School of Medicine, Seoul National University Children's Hospital, South Korea (G.B.K.).""}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Nowlen', 'Affiliation': ""Heart Center, Phoenix Children's Hospital, AZ (T.T.N.).""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'DiMaria', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (M.V.D.).""}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Frischhertz', 'Affiliation': 'Division of Cardiology, Vanderbilt University School of Medicine, Nashville, TN (B.P.F.).'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Wagner', 'Affiliation': ""Divisions of Cardiology and Clinical Pharmacology, Children's Mercy Kansas City, MO (J.B.W.).""}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'McHugh', 'Affiliation': 'Division of Pediatric Cardiology, Medical University of South Carolina, Charleston (K.E.M.).'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, The Hospital for Sick Children, University of Toronto, Ontario (B.W.M.).'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Shillingford', 'Affiliation': 'Nemours Cardiac Center, Nemours/Alfred I. DuPont Hospital for Children, Wilmington, DE (A.J.S.).'}, {'ForeName': 'Arash A', 'Initials': 'AA', 'LastName': 'Sabati', 'Affiliation': ""Los Angeles Children's Hospital, Division of Cardiology, CA (A.A.S.).""}, {'ForeName': 'Anji T', 'Initials': 'AT', 'LastName': 'Yetman', 'Affiliation': ""Children's Hospital and Medical Center, University of Nebraska, Omaha (A.T.Y.).""}, {'ForeName': 'Anitha S', 'Initials': 'AS', 'LastName': 'John', 'Affiliation': ""Division of Cardiology, Children's National Health System, Washington, DC (A.S.J.).""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': ""Division of Pediatric Cardiology, Morgan Stanley Children's Hospital, Columbia University Medical Center, New York, NY (M.E.R.).""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Files', 'Affiliation': ""Division of Cardiology, Seattle Children's Hospital, WA (M.D.F.).""}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Payne', 'Affiliation': 'Division of Cardiology, Riley Hospital for Children, Indianapolis, IN (R.M.P.).'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Division of Cardiology, Stollery Children's Hospital, Edmonton, Alberta, Canada (A.S.M.).""}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Davis', 'Affiliation': ""Division of Cardiology, Rady Children's Hospital, San Diego, CA (C.K.D.).""}, {'ForeName': 'Shabana', 'Initials': 'S', 'LastName': 'Shahanavaz', 'Affiliation': ""Division of Cardiology, St Louis Children's Hospital, MO (S.S.).""}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': ""Duke Children's Pediatric and Congenital Heart Center, Durham, NC (K.D.H.).""}, {'ForeName': 'Ruchira', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (R.G.).'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': ""Johns Hopkins All Children's Hospital, Department of Surgery, St Petersburg, FL (J.P.J.).""}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Woyciechowski', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Rathge', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McBride', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Frommelt', 'Affiliation': ""Division of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).""}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Russell', 'Affiliation': ""Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Yeager', 'Affiliation': 'Consultant to Mezzion Pharma Co Ltd, Mezzion Pharma Co Ltd, Seoul, South Korea (J.L.Y.).'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Mario P', 'Initials': 'MP', 'LastName': 'Stylianou', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Pearson', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Paridon', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044352']
3235,31111313,Additive effect of continuous adductor canal block and liposomal bupivacaine periarticular injection in total knee arthroplasty.,"BACKGROUND


Novel methods of postoperative analgesia for total knee arthroplasty (TKA) have demonstrated improved functional outcomes and decreased narcotic consumption. These approaches include continuous adductor canal blocks (CACB) and periarticular injection (PAI). There is a lack of current understanding regarding the effect of these modalities on narcotic usage, functionality, and pain when both PAI and CACB are utilized compared to PAI alone.
METHODS


TKAs were performed unilaterally by a single surgeon with a standardized protocol. Patients were divided into two groups: those receiving PAI alone (n = 54) and those receiving PAI and CACB (n = 37). Patient outcomes including, narcotics usage, pain scale, and distance walked, were recorded on postoperative day (POD) zero through three.
RESULTS


When compared with PAI alone, it was identified that concurrent use of PAI and CACB results in a statistically significant decrease in narcotics usage on POD 0, 1, 3, and total narcotic usage while admitted. Patients in the PAI and CACB group walked significantly farther than patients in the PAI only group on POD 1, 2, and 3. On POD 0, patients in the PAI and CACB reported significantly less pain with activity when compared to the PAI only group.
CONCLUSION


Here we identify an additive effect when utilizing both PAI and CACB for postoperative TKA analgesia. Our findings demonstrate significant decrease in patient total narcotic usage, pain scores, and an increase in walking distance when utilizing PAI and CACB compared with PAI alone. This analgesic technique may help reduce patients' narcotic use while also increasing functional outcomes.",2019,"Patients in the PAI and CACB group walked significantly farther than patients in the PAI only group on POD 1, 2, and 3.","['TKAs were performed unilaterally by a single surgeon with a standardized protocol', 'total knee arthroplasty', 'total knee arthroplasty (TKA']","['continuous adductor canal blocks (CACB) and periarticular injection (PAI', 'PAI and CACB', 'PAI alone', 'CACB', 'continuous adductor canal block and liposomal bupivacaine periarticular injection']","['walking distance', 'narcotics usage on POD 0, 1, 3, and total narcotic usage', 'pain with activity', 'patient total narcotic usage, pain scores', 'narcotics usage, pain scale, and distance walked, were recorded on postoperative day (POD) zero through three']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394854', 'cui_str': 'Periarticular injection (procedure)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]",,0.0296591,"Patients in the PAI and CACB group walked significantly farther than patients in the PAI only group on POD 1, 2, and 3.","[{'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Green', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Frane', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'Ganz', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA. maxganz10@gmail.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stockton', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Stapleton', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mallen', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02452-0']
3236,31119383,Blood loss reduction: effect of different knee prosthesis designs and use of tranexamic acid-a randomized controlled trial.,"PURPOSE


In regard to blood loss in total knee arthroplasty (TKA), the effect of either knee prosthesis designs or bone preparation is still unclear. While the benefit of using tranexamic acid (TXA) is well demonstrated, our study aims to determine the effect of different knee prosthesis designs uses and efficacy of blood loss reduction by different routes of TXA administration.
METHODS


The 228 patients undergone primary TKA were randomized to determine between open-box and closed-box prosthesis. Among each group, a second randomization was applied to categorize the patients into (1) no use of TXA (No-TXA), (2) intra-articular TXA use (IA-TXA) and (3) intravenous TXA use (IV-TXA). The calculated blood loss (CBL), drain volume (DV) and an average number of units of blood transfused (ANUBT) were blindly evaluated.
RESULTS


The open-box TKA had 85.60 and 63.29 ml (p = 0.02 and p < 0.01) more CBL and DV compared to closed-box TKA. The IA-TXA and IV-TXA significantly reduced CBL by 190.75 and 162.01 ml (p < 0.01 and p < 0.01) and reduced DV by 129.07 and 61.04 ml (p < 0.01 and p = 0.01), respectively, when compared to No-TXA. Patients who received IA and IV-TXA had ANUBT of 0.21 and 0.23 unit, which was significantly lower than 0.42 unit of No-TXA group (p = 0.03).
CONCLUSIONS


Use of the different prosthesis designs could significantly affect CBL and DV following TKA. However, the use of either design resulted in a comparable ANUBT. Regardless of prosthetic type, either IA- or IV-TXA could significantly reduce the CBL and ANUBT when compared to No-TXA.",2019,(p = 0.02 and p < 0.01) more CBL and DV compared to closed-box TKA.,"['228 patients undergone primary TKA', 'total knee arthroplasty (TKA']","['TXA (No-TXA), (2) intra-articular TXA use (IA-TXA) and (3) intravenous TXA use (IV-TXA', 'tranexamic acid', 'IA and IV-TXA', 'tranexamic acid (TXA', 'open-box and closed-box prosthesis', 'IA- or IV-TXA', 'IA-TXA and IV-TXA']","['CBL and DV', 'CBL', 'reduced DV', 'CBL and ANUBT', 'calculated blood loss (CBL), drain volume (DV) and an average number of units of blood transfused (ANUBT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C1265318', 'cui_str': 'Cytophaga-like bacteria (organism)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449961', 'cui_str': 'Number of units (qualifier value)'}, {'cui': 'C0005768'}]",228.0,0.0392803,(p = 0.02 and p < 0.01) more CBL and DV compared to closed-box TKA.,"[{'ForeName': 'Artit', 'Initials': 'A', 'LastName': 'Laoruengthana', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Piti', 'Initials': 'P', 'LastName': 'Rattanaprichavej', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand. pt-rp@hotmail.com.'}, {'ForeName': 'Nattharut', 'Initials': 'N', 'LastName': 'Chaibhuddanugul', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Panapol', 'Initials': 'P', 'LastName': 'Varakornpipat', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Monton', 'Initials': 'M', 'LastName': 'Galassi', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Krit', 'Initials': 'K', 'LastName': 'Pongpirul', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02450-2']
3237,31377713,Protocolized Post-Extubation Respiratory Support to prevent reintubation: protocol and statistical analysis plan for a clinical trial.,"INTRODUCTION


Following extubation from invasive mechanical ventilation, nearly one in seven critically ill adults requires reintubation. Reintubation is independently associated with increased mortality. Postextubation respiratory support (non-invasive ventilation or high-flow nasal cannula applied at the time of extubation) has been reported in small-to-moderate-sized trials to reduce reintubation rates among hypercapnic patients, high-risk patients without hypercapnia and low-risk patients without hypercapnia. It is unknown whether protocolised provision of postextubation respiratory support to every patient undergoing extubation would reduce the overall reintubation rate, compared with usual care.
METHODS AND ANALYSIS


The Protocolized Post-Extubation Respiratory Support (PROPER) trial is a pragmatic, cluster cross-over trial being conducted between 1 October 2017 and 31 March 2019 in the medical intensive care unit of Vanderbilt University Medical Center. PROPER compares usual care versus protocolized post-extubation respiratory support (a respiratory therapist-driven protocol that advises the provision of non-invasive ventilation or high-flow nasal cannula based on patient characteristics). For the duration of the trial, the unit is divided into two clusters. One cluster receives protocolised support and the other receives usual care. Each cluster crosses over between treatment group assignments every 3 months. All adults undergoing extubation from invasive mechanical ventilation are enrolled except those who received less than 12 hours of mechanical ventilation, have 'Do Not Intubate' orders, or have been previously reintubated during the hospitalisation. The anticipated enrolment is approximately 630 patients. The primary outcome is reintubation within 96 hours of extubation.
ETHICS AND DISSEMINATION


The trial was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03288311.",2019,Reintubation is independently associated with increased mortality.,"['hypercapnic patients, high-risk patients without hypercapnia and low-risk patients without hypercapnia', '630 patients', '1 October 2017 and 31 March 2019 in the medical intensive care unit of Vanderbilt University Medical Center', ""All adults undergoing extubation from invasive mechanical ventilation are enrolled except those who received less than 12\u2009hours of mechanical ventilation, have 'Do Not Intubate' orders, or have been previously reintubated during the hospitalisation""]",['Postextubation respiratory support (non-invasive ventilation or high-flow nasal cannula'],"['overall reintubation rate', 'mortality', 'reintubation within 96\u2009hours of extubation']","[{'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C2711734', 'cui_str': 'Medical intensive care unit'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]",630.0,0.137373,Reintubation is independently associated with increased mortality.,"[{'ForeName': 'Jonathan Dale', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Vaughan', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Lloyd', 'Affiliation': 'Division of Respiratory Care, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Bilas', 'Affiliation': 'Department of Anesthesiology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Hall', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Toporek', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Buell', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Brown', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Roger K', 'Initials': 'RK', 'LastName': 'Richardson', 'Affiliation': 'Division of Respiratory Care, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'J Craig', 'Initials': 'JC', 'LastName': 'Rooks', 'Affiliation': 'Division of Respiratory Care, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-030476']
3238,31477783,Do young children consistently meet 24-h sleep and activity guidelines? A longitudinal analysis using actigraphy.,"BACKGROUND


Existing studies examining adherence to 24-h movement guidelines in young children are mostly cross sectional and have not assessed additional guidelines relating to activity intensity or regularity in sleep patterns. The aims of this study were to determine adherence to full sleep, activity, and sedentary behaviour guidelines from 1-5 years of age, whether adherence tracked over time, and how adherence was related to body composition cross sectionally and prospectively.
SUBJECTS/METHODS


Data were obtained from 547 children who were participants in a randomised controlled trial. At 1, 2, and 5 years of age, children wore Actical accelerometers 24-h a day for 5-7 days, height and weight were measured, and parents completed questionnaires on screen time and restraint (1 and 2 years only). A dual-energy x-ray absorptiometry (DXA) scan measured body composition at 5 years of age.
RESULTS


Although adherence to general sleep and activity guidelines was high, few children had regular sleep patterns. Adherence to all three guidelines ranged from 12.3 to 41.3% at the different ages, although these estimates decreased to 0.6-9.3% when activity intensity (60 min of energetic play) and sleep regularity (consistent sleep and wake times) were included. Children who met all three guidelines at a given age were more likely to meet all three guidelines at a subsequent age (odds ratio, 95% CI: 2.6, 1.04-6.4 at 1 year and 2.5, 1.1-5.9 at 2 years). However, adherence to meeting all three guidelines at earlier ages was not related to BMI z-score or body composition at age 5, either cross sectionally or prospectively.
CONCLUSIONS


Strategies to promote adherence to movement guidelines among young children are warranted, particularly to reduce screen time, and encouraging regular sleep patterns.",2019,"However, adherence to meeting all three guidelines at earlier ages was not related to BMI z-score or body composition at age 5, either cross sectionally or prospectively.
","['young children', 'Data were obtained from 547 children who were participants in a randomised controlled trial']",['dual-energy x-ray absorptiometry (DXA) scan'],"['Adherence', 'sleep regularity (consistent sleep and wake times', 'adherence to full sleep, activity, and sedentary behaviour guidelines']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1959592', 'cui_str': 'DEXA Scan'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449581', 'cui_str': 'Regularity (attribute)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",547.0,0.0356099,"However, adherence to meeting all three guidelines at earlier ages was not related to BMI z-score or body composition at age 5, either cross sectionally or prospectively.
","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Meredith-Jones', 'Affiliation': 'Department of Medicine, Dunedin, New Zealand. kim.meredith-jones@otago.ac.nz.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, Dunedin, New Zealand.""}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Haszard', 'Affiliation': 'Department of Medicine, Dunedin, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Centre for Biostatistics, Dunedin, New Zealand.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sayers', 'Affiliation': ""Department of Women's and Children's Health, Dunedin, New Zealand.""}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': ""Department of Women's and Children's Health, Dunedin, New Zealand.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': ""Dunedin School of Medicine Dean's Office, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, Dunedin, New Zealand.'}]",International journal of obesity (2005),['10.1038/s41366-019-0432-y']
3239,32088160,The effects of cast-related training for nurses on the quality of cast care: A quasi-experimental study.,"INTRODUCTION


Quality cast application and care is among the nursing skills which require competence, knowledge, and expertise. This study aimed to assess the effects of cast-related training for nurses on the quality of pre-, intra- and post-casting care.
METHODS


This quasi-experimental study was conducted in 2018 in two phases: before and after a cast-related training for nurses involved in cast application and care. In the first phase, 94 patients with a cast were assessed for pre- intra- and post-casting care quality. In the second phase, after the training program, the same number of new patients were assessed. Study data were collected using a 57-item checklist with items on; patient preparation, cast application, and post-casting care including patient education. Descriptive statistics, Fisher's exact, and independent-samples t-tests were used to analyze the data.
RESULTS


The mean pre-casting care score significantly increased from 1.39 ± 0.16 at baseline to 1.69 ± 0.32 after the intervention (P = 0.001). The mean intra-casting care score increased from 1.42 ± 0.31 at baseline to 1.52 ± 0.17 after the intervention (P = 0.014). However, the study intervention did not improve the mean post-casting care score.
CONCLUSION


This training program improved the quality of pre- and intra-casting care, but did not improve the post-casting care and care measures related to patient education. Therefore, regular in-service training programs for nurses are recommended to improve their knowledge, skills, and performance in cast- pplication and care.",2020,"This training program improved the quality of pre- and intra-casting care, but did not improve the post-casting care and care measures related to patient education.","['94 patients with a cast', '2018 in two phases: before and after a cast-related training for nurses involved in cast application and care']",['cast-related training'],"['mean pre-casting care score', 'mean intra-casting care score', 'quality of pre- and intra-casting care', 'mean post-casting care score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0687121', 'cui_str': 'Application of cast (procedure)'}]","[{'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0184573', 'cui_str': 'Cast care: maintenance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",94.0,0.0185021,"This training program improved the quality of pre- and intra-casting care, but did not improve the post-casting care and care measures related to patient education.","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. Electronic address: razieh.mokhtari91@gmail.com.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Adib-Hajbaghery', 'Affiliation': 'Trauma Nursing Research Center, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: adib1344@yahoo.com.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Autoimmune Disease Research Center, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: m4.rezaei@gmail.com.'}]",International journal of orthopaedic and trauma nursing,['10.1016/j.ijotn.2020.100768']
3240,28444114,"Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study.","Background


In the phase 3 RADIANT-2 study, everolimus plus octreotide long-acting repeatable (LAR) showed improvement of 5.1 months in median progression-free survival versus placebo plus octreotide LAR among patients with advanced neuroendocrine tumors associated with carcinoid syndrome. The progression-free survival P-value was marginally above the prespecified threshold for statistical significance. Here, we report final overall survival (OS) and key safety update from RADIANT-2.
Patients and methods


The RADIANT-2 trial compared everolimus (10 mg/day, orally; n = 216) versus placebo (n = 213), both in conjunction with octreotide LAR (30 mg, intramuscularly, every 28 days). Patients, unblinded at the time of progression or after end of double-blind core phase following primary analysis, were offered open-label everolimus with octreotide LAR (open-label phase). In the open-label phase, patients had similar safety and efficacy assessments as those in the core phase. For OS, hazard ratios (HRs) with 95% CIs using unadjusted Cox model and a Cox model adjusted for prespecified baseline covariates were calculated.
Results


A total of 170 patients received open-label everolimus (143 crossed over from the placebo arm; 27 in the everolimus arm continued to receive the same treatment after unblinding). The median OS (95% CI) after 271 events was 29.2 months (23.8-35.9) for the everolimus arm and 35.2 months (30.0-44.7) for the placebo arm (HR, 1.17; 95% CI, 0.92-1.49). HR adjusted for baseline covariates was 1.08 (95% CI, 0.84-1.38). The most frequent drug-related grade 3 or 4 AEs reported during the open-label phase were diarrhea (5.3%), fatigue (4.7%), and stomatitis (4.1%). Deaths related to pulmonary or cardiac failure were observed more frequently in the everolimus arm.
Conclusion


No significant difference in OS was observed for the everolimus plus octreotide LAR and placebo plus octreotide LAR arms of the RADIANT-2 study, even after adjusting for imbalances in the baseline covariates.
Clinical Trial Number


NCT00412061, www.clinicaltrials.gov.",2017,"No significant difference in OS was observed for the everolimus plus octreotide LAR and placebo plus octreotide LAR arms of the RADIANT-2 study, even after adjusting for imbalances in the baseline covariates.
","['patients with advanced neuroendocrine tumor and carcinoid syndrome', 'patients with advanced neuroendocrine tumors associated with carcinoid syndrome', '170 patients received']","['everolimus', 'octreotide LAR', 'placebo', 'placebo plus octreotide LAR', 'everolimus plus octreotide long-acting repeatable (LAR', 'open-label everolimus with octreotide LAR (open-label phase', 'everolimus plus octreotide LAR', 'open-label everolimus']","['fatigue', 'Deaths related to pulmonary or cardiac failure', 'OS', 'median progression-free survival', 'For OS, hazard ratios (HRs', 'median OS', 'progression-free survival P-value', 'overall survival (OS) and key safety update', 'diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0024586', 'cui_str': 'Malignant Carcinoid Syndrome'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",170.0,0.361109,"No significant difference in OS was observed for the everolimus plus octreotide LAR and placebo plus octreotide LAR arms of the RADIANT-2 study, even after adjusting for imbalances in the baseline covariates.
","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Pavel', 'Affiliation': 'Department of Hepatology and Gastroenterology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baudin', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Institut Gustave-Roussy, Villejuif Cedex, France.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Öberg', 'Affiliation': 'Department of Endocrine Oncology, University Hospital, Uppsala, Sweden.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Hainsworth', 'Affiliation': 'Sarah Cannon Research Institute, Nashville.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rouyrre', 'Affiliation': 'Novartis International AG, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Department of Oncology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Gross', 'Affiliation': 'Neuroendocrine Tumor Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Yao', 'Affiliation': 'Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx193']
3241,32085778,Protocol for a parallel economic evaluation of a trial comparing two surgical strategies in severe complicated intra-abdominal sepsis: the COOL-cost study.,"BACKGROUND


The risk of death in severe complicated intra-abdominal sepsis (SCIAS) remains high despite decades of surgical and antimicrobial research. New management strategies are required to improve outcomes. The Closed Or Open after Laparotomy (COOL) trial investigates an open-abdomen (OA) approach with active negative pressure peritoneal therapy. This therapy is hypothesized to better manage peritoneal bacterial contamination, drain inflammatory ascites, and reduce the risk of intra-abdominal hypertension leading to improved survival and decreased complications. The total costs and cost-effectiveness of this therapy (as compared with standard fascial closure) are unknown.
METHODS


We propose a parallel cost-utility analysis of this intervention to be conducted alongside the 1-year trial, extrapolating beyond that using decision analysis. Using resource use metrics (e.g., length of stay, re-admissions) from patients at all study sites and microcosting data from patients enrolled in Calgary, Alberta, the mean cost difference between treatment arms will be established from a publicly-funded health care payer perspective. Quality of life will be measured at 6 months and 1 year postoperatively with the Euroqol EQ-5D-5 L and SF-36 surveys. A within-trial analysis will establish cost and utility at 1 year, using a bootstrapping approach to provide confidence intervals around an estimated incremental cost-effectiveness ratio. If neither operative strategy is economically dominant, Markov modeling will be used to extrapolate the cost per quality-adjusted life years gained to 2-, 5-, 10-year, and lifetime horizons. Future costs and benefits will be discounted at 1.5% per annum. A cost-effectiveness acceptability curve will be generated using Monte Carlo simulation. If all trial outcomes are similar, the primary analysis will default to a cost-minimization approach. Subgroup analysis will be carried out for patients with and without septic shock at presentation, and for patients whose initial APACHE II scores are > 20 versus ≤ 20.
DISCUSSION


In addition to an estimate of the clinical effectiveness of an OA approach for SCIAS, an understanding of its cost effectiveness will be required prior to its adoption in any resource-constrained environment. We will estimate this key parameter for use by clinicians and policymakers.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03163095, registered May 22, 2017.",2020,Quality of life will be measured at 6 months and 1 year postoperatively with the Euroqol EQ-5D-5 L and SF-36 surveys.,['severe complicated intra-abdominal sepsis'],['open-abdomen (OA) approach with active negative pressure peritoneal therapy'],"['Quality of life', 'total costs and cost-effectiveness']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1141926', 'cui_str': 'Abdominal sepsis'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.240952,Quality of life will be measured at 6 months and 1 year postoperatively with the Euroqol EQ-5D-5 L and SF-36 surveys.,"[{'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Ng-Kamstra', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary, 2500 University Drive NW, Calgary, Alberta, T2N 1\u2009N4, Canada. josh.ngkamstra@gmail.com.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Rennert-May', 'Affiliation': 'Department of Medicine, Section of Infectious Diseases, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McKee', 'Affiliation': 'Department of Surgery, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Skyla', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': 'Surgical Services, Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Manns', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary, 2500 University Drive NW, Calgary, Alberta, T2N 1\u2009N4, Canada.'}]",World journal of emergency surgery : WJES,['10.1186/s13017-020-00294-4']
3242,31377976,Mediators of physical activity adoption and maintenance among breast cancer survivors.,"The purpose of this study is to explore the mediators associated with physical activity (PA) within the adoption and maintenance phase of a PA intervention trial among breast cancer survivors. Overall, 192 breast cancer survivors (average age = 55.9 years) were randomized to an Intervention or Control group. Both groups received 8 calls in the first 3-months, 3 monthly calls, and then entered a no-contact maintenance phase for the remaining 6-months. Assessments were completed at baseline, 3-months, 6-months and 12-months. On average, participants were 55.9 years of age (SD = 9.8) and 2.9 years since diagnosis (SD = 2.2). In the adoption phase, all significant univariate mediators (self-efficacy, cognitive and behavioral processes and decisional balance cons) were included in the multivariate model. Results suggest self-efficacy (ab = 13.56, SE = 7.04) and behavioral processes (ab = 36.10, SE = 12.22) were significant for PA adoption. No mediators were identified in the maintenance phase. In the adoption phase, there were significant indirect effects of group on PA adoption through self-efficacy and behavioral processes. There were no indirect effects of group on PA maintenance.",2020,There were no indirect effects of group on PA maintenance.,"['breast cancer survivors', 'participants were 55.9\xa0years of age (SD\u2009=\u20099.8) and 2.9\xa0years since diagnosis (SD\u2009=\u20092.2', '192 breast cancer survivors (average age\u2009=\u200955.9\xa0years']",['physical activity (PA'],"['behavioral processes', 'self-efficacy', 'univariate mediators (self-efficacy, cognitive and behavioral processes and decisional balance cons']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517623', 'cui_str': '192'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",192.0,0.0162125,There were no indirect effects of group on PA maintenance.,"[{'ForeName': 'Madison M', 'Initials': 'MM', 'LastName': 'Kindred', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC, USA. demello@mailbox.sc.edu.'}, {'ForeName': 'Bernardine M', 'Initials': 'BM', 'LastName': 'Pinto', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00085-6']
3243,32045409,"A multicomponent secondary school health promotion intervention and adolescent health: An extension of the SEHER cluster randomised controlled trial in Bihar, India.","BACKGROUND


Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health (SEHER) is a multicomponent, whole-school health promotion intervention delivered by a lay counsellor or a teacher in government-run secondary schools in Bihar, India. The objective of this study is to examine the effects of the intervention after two years of follow-up and to evaluate the consistency of the findings observed over time.
METHODS AND FINDINGS


We conducted a cluster randomised trial in which 75 schools were randomised (1:1:1) to receive the SEHER intervention delivered by a lay counsellor (SEHER Mitra [SM]) or a teacher (Teacher as SEHER Mitra [TSM]), respectively, alongside a standardised, classroom-based life skills Adolescence Education Program (AEP), compared to AEP alone (control group). The trial design was a repeat cross-sectional study. Students enrolled in grade 9 (aged 13-15 years) in the 2015-2016 academic year were exposed to the intervention for two years and the outcome assessment was conducted at three time points─at baseline in June 2015; 8-months follow-up in March 2016, when the students were still in grade 9; and endpoint at 17-months follow-up in December 2016 (when the students were in grade 10), the results of which are presented in this paper. The primary outcome, school climate, was measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Intervention effects were estimated using mixed-effects linear or logistic regression, including a random effect to adjust for within-school clustering, minimisation variables, baseline cluster-level score of the outcome, and sociodemographic characteristics. In total, 15,232 students participated in the 17-month survey. Compared with the control group, the participants in the SM intervention group reported improvements in school climate (adjusted mean difference [aMD] = 7.33; 95% CI: 6.60-8.06; p < 0.001) and most secondary outcomes (depression: aMD = -4.64; 95% CI: -5.83-3.45; p < 0.001; attitude towards gender equity: aMD = 1.02; 95% CI: 0.65-1.40; p < 0.001; frequency of bullying: aMD = -2.77; 95% CI: -3.40 to -2.14; p < 0.001; violence victimisation: odds ratio [OR] = 0.08; 95% CI: 0.04-0.14; p < 0.001; and violence perpetration: OR = 0.16; 95% CI: 0.09-0.29; p < 0.001). There was no evidence of an intervention effect in the TSM group compared with control group. The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] = 2.23 [1.97-2.50] versus 1.88 [1.44-2.32], p < 0.001); depression (ES [95% CI] = -1.19 [-1.56 to -0.82] versus -0.27 [-0.44 to -0.11], p < 0.001); attitude towards gender equity (ES [95% CI] = 0.53 [0.27-0.79] versus 0.23 [0.10-0.36], p < 0.001); bullying (ES [95% CI] = -2.22 [-2.84 to -1.60] versus -0.47 [-0.61 to -0.33], p < 0.001); violence victimisation (OR [95% CI] = 0.08 [0.04-0.14] versus 0.62 [0.46-0.84], p < 0.001); and violence perpetration (OR [95% CI] = 0.16 [0.09-0.29] versus 0.68 [0.48-0.96], p < 0.001), suggesting incremental benefits with an extended intervention. A limitation of the study is that 27% of baseline participants did not complete the 17-month outcome assessment.
CONCLUSIONS


The trial showed that the second-year outcomes were similar to the first-year outcomes, with no effect of the teacher-led intervention and larger benefits on school climate and adolescent health accruing from extending lay counsellor-delivered intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02907125.",2020,The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] =,"['A\xa0multicomponent secondary school health promotion intervention and adolescent health', '15,232 students participated in the 17-month survey', '75 schools', 'Students enrolled in grade 9 (aged 13-15 years) in the 2015-2016 academic year']","['TSM', 'SM intervention', 'SEHER intervention delivered by a lay counsellor (SEHER Mitra [SM]) or a teacher (Teacher as SEHER Mitra']","['school climate and adolescent health', 'school climate, was measured with the Beyond Blue School Climate Questionnaire (BBSCQ', 'school climate', 'violence perpetration', 'violence victimisation']","[{'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]",15232.0,0.238933,The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] =,"[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Shinde', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Khandeparkar', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ross', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Patton', 'Affiliation': ""Murdoch Children's Research Institute, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}]",PLoS medicine,['10.1371/journal.pmed.1003021']
3244,31991216,Impact of a Formal Advance Care Planning Program on End-of-Life Care for Patients With Heart Failure: Results From a Randomized Controlled Trial.,"BACKGROUND


There is no evidence on effectiveness of advance care planning (ACP) among patients with heart failure (HF). We examined the effect of an ACP program in facilitating end of life (EOL) care consistent with the preferences of patients with HF (primary aim), and on their decisional conflict, discussion with surrogates, illness understanding, anxiety, depression, and quality of life (secondary aims).
METHODS


We randomized 282 patients with HF to receive ACP (n=93) or usual care (control arm, n=189). Primary outcomes were assessed among deceased (n=89) and secondary outcomes from baseline and 6 follow-ups conducted every 4 months.
RESULTS


Deceased patients in the ACP arm were no more likely than those in control arm to have wishes followed for EOL treatments (ACP: 35%, Control: 44%; P= .47), or place of death (ACP: 52%, Control: 51%; P = .1.00). A higher proportion in the ACP arm had wishes followed for cardiopulmonary resuscitation (ACP: 83%, Control: 62%; P = .12). At first follow-up, patients with ACP had lower decisional conflict (β = -10.8, P< .01) and were more likely to discuss preferences with surrogates (β = 1.3, P = .04). ACP did not influence other outcomes.
CONCLUSION


This trial did not confirm that our ACP program was effective in facilitating EOL care consistent with patient preferences. The program led to short-term improvements in the decision-making.",2020,"Deceased patients in ACP arm were no more likely than those in control arm to have wishes followed for EOL treatments (ACP: 35%, Control: 44%; p=0.47), or place of death (ACP: 52%, Control: 51%; p-value=1.00).","['heart failure (HF) patients', 'patients with heart failure', '282 HF patients to receive ACP (n=93) or usual care (control arm, n=189']","['formal advance care planning program', 'ACP program', 'Advance care planning (ACP', 'ACP']","['decisional conflict', 'anxiety, depression and quality of life (secondary aims']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",282.0,0.0945932,"Deceased patients in ACP arm were no more likely than those in control arm to have wishes followed for EOL treatments (ACP: 35%, Control: 44%; p=0.47), or place of death (ACP: 52%, Control: 51%; p-value=1.00).","[{'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Malhotra', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore. Electronic address: chetna.malhotra@duke-nus.edu.sg.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Fazlur Rehman', 'Initials': 'FR', 'LastName': 'Jaufeerally', 'Affiliation': 'Singapore General Hospital, Outram Road, Singapore.'}, {'ForeName': 'Meibo', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Nadkarni', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Clarice Shu Hwa', 'Initials': 'CSH', 'LastName': 'Ng', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Boon Cheng', 'Initials': 'BC', 'LastName': 'Tan', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Jing Fen', 'Initials': 'JF', 'LastName': 'Lim', 'Affiliation': 'Singapore General Hospital, Outram Road, Singapore.'}, {'ForeName': 'Claire Ya-Ting', 'Initials': 'CY', 'LastName': 'Chuang', 'Affiliation': 'Singapore General Hospital, Outram Road, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.01.015']
3245,32085836,"Safety and efficacy of GABA A  α5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial.","BACKGROUND


S44819, a selective GABA A  α5 receptor antagonist, reduces tonic post-ischaemic inhibition of the peri-infarct cortex. S44819 improved stroke recovery in rodents and increased cortical excitability in a transcranial magnetic stimulation study in healthy volunteers. The Randomized Efficacy and Safety Trial of Oral GABA A  α5 antagonist S44819 after Recent ischemic Event (RESTORE BRAIN) aimed to evaluate the safety and efficacy of S44819 for enhancing clinical recovery of patients with ischaemic stroke.
METHODS


RESTORE BRAIN was an international, randomised, double-blind, parallel-group, placebo-controlled, multicentre phase 2 trial that evaluated the safety and efficacy of oral S44189 in patients with recent ischaemic stroke. The study was done in specialised stroke units in 92 actively recruiting centres in 14 countries: ten were European countries (Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, and the UK) and four were non-European countries (Australia, Brazil, Canada, and South Korea). Patients aged 18-85 years with acute ischaemic stroke involving cerebral cortex (National Institute of Health Stroke Scale [NIHSS] score 7-20) without previous disability were eligible for inclusion. Participants were randomly assigned to receive 150 mg S44819 twice a day, 300 mg S44819 twice a day, or placebo twice a day by a balanced, non-adaptive randomisation method with a 1:1:1 ratio. Treatment randomisation and allocation were centralised via the interactive web response system using computer-generated random sequences with a block size of 3. Blinding of treatment was achieved by identical appearance and taste of all sachets. Patients, investigators and individuals involved in the analysis of the trial were masked to group assignment. The primary endpoint was the modified Rankin Scale (mRS) score 90 days from onset of treatment, evaluated by shift analysis (predefined main analysis) or by dichotomised analyses using 0-1 versus 2-6 and 0-2 versus 3-6 cutoffs (predefined secondary analysis). Secondary endpoints were the effects of S44819 on the NIHSS and Montreal Cognitive Assessment (MoCA) scores, time needed to complete parts A and B of the Trail Making Test, and the Barthel index. Efficacy analyses were done on all patients who received at least one dose of treatment and had at least one mRS score taken after day 5 (specifically, on or after day 30). Safety was compared across treatment groups for all patients who received at least one dose of treatment. The study was registered at ClinicalTrials.gov, NCT02877615.
FINDINGS


Between Dec 19, 2016, and Nov 16, 2018, 585 patients were enrolled in the study. Of these, 197 (34%) were randomly assigned to receive 150 mg S44819 twice a day, 195 (33%) to receive 300 mg S44819 twice a day, and 193 (33%) to receive placebo twice a day. 189 (96%) of 197 patients in the 150 mg S44819 group, 188 (96%) of 195 patients in the 300 mg S44819 group, and 191 (99%) patients in the placebo group received at least one dose of treatment and had at least one mRS score taken after day 5, and were included in efficacy analyses. 195 (99%) of 197 patients in the 150 mg S44819 group, 194 (99%) of 195 patients in the 300 mg S44819 group, and 193 (100%) patients in the placebo group received at least one dose of treatment, and were included in safety analyses. The primary endpoint of mRS at day 90 did not differ between each of the two S44819 groups and the placebo group (OR 0·91 [95% CI 0·64-1·31]; p=0·80 for 150 mg S44819 compared with placebo and OR 1·17 [95% CI 0·81-1·67]; p=0·80 for 300 mg S44819 compared with placebo). Likewise, dichotomised mRS scores at day 90 (mRS 0-2 vs 3-6 or mRS 0-1 vs 2-6) did not differ between groups. Secondary endpoints did not reveal any significant group differences. The median NIHSS score at day 90 did not differ between groups (4 [IQR 2-8] in 150 mg S44819 group, 4 [2-7] in 300 mg S44819 group, and 4 [2-6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group). Likewise, the median MoCA score (22·0 [IQR 17·0-26·0] in 150 mg S44819 group, 23·0 [19·0-26·5] in 300 mg S44819 group, and 22·0 [17·0-26·0] in placebo group), time needed to complete parts A (50 s [IQR 42-68] in 150 mg S44819 group, 49 s [36-63] in 300 mg S44819 group, and 50 s [38-68] in placebo group) and B (107 s [81-144] in 150 mg S44819 group, 121 s [76-159] in 300 mg S44819 group, and 130 s [86-175] in placebo group) of the Trail Making Test, and the Barthel index (90 [IQR 60-100] in 150 mg S44819 group, 90 [70-100] in 300 mg S44819 group, and 90 [70-100] in placebo group) were similar in all groups. Number and type of adverse events were similar between the three groups. There were no drug-related adverse events and no drug-related deaths.
INTERPRETATION


There was no evidence that S44819 improved clinical outcome in patients after ischaemic stroke, and thus S44819 cannot be recommended for stroke therapy. The concept of tonic inhibition after stroke should be re-evaluated in humans.
FUNDING


Servier.",2020,"The median NIHSS score at day 90 did not differ between groups (4 [IQR 2-8] in 150 mg S44819 group, 4 [2-7] in 300 mg S44819 group, and 4 [2-6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group).","['healthy volunteers', 'specialised stroke units in 92 actively recruiting centres in 14 countries: ten were European countries (Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, and the UK) and four were non-European countries (Australia, Brazil, Canada, and South Korea', '300 mg S44819 group, and 22·0', 'patients with ischaemic stroke', 'Between Dec 19, 2016, and Nov 16, 2018, 585 patients were enrolled in the study', 'patients with recent ischaemic stroke', 'Patients aged 18-85 years with acute ischaemic stroke involving cerebral cortex (National Institute of Health Stroke Scale [NIHSS] score 7-20) without previous disability were eligible for inclusion']","['S44819', 'oral S44189', 'Oral GABA A', 'placebo', 'GABA A', 'α5 antagonist S44819']","['dichotomised mRS scores', 'Number and type of adverse events', 'effects of S44819 on the NIHSS and Montreal Cognitive Assessment (MoCA) scores, time needed to complete parts A and B of the Trail Making Test, and the Barthel index', 'median MoCA score', 'mRS', 'stroke recovery', 'Safety', 'safety and efficacy', 'time needed to complete parts A', 'cortical excitability', 'modified Rankin Scale (mRS) score', 'median NIHSS score']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4705846', 'cui_str': 'S44819'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C3472498', 'cui_str': 'National Institutes of Health stroke scale score (observable entity)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C4705846', 'cui_str': 'S44819'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4705846', 'cui_str': 'S44819'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",585.0,0.542813,"The median NIHSS score at day 90 did not differ between groups (4 [IQR 2-8] in 150 mg S44819 group, 4 [2-7] in 300 mg S44819 group, and 4 [2-6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group).","[{'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Chabriat', 'Affiliation': 'Department of Neurology, Lariboisière Hospital, Paris Diderot University and INSERM U1141, Paris, France.'}, {'ForeName': 'Claudio L', 'Initials': 'CL', 'LastName': 'Bassetti', 'Affiliation': 'Department of Neurology, University Hospital Berne, Berne, Switzerland.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Marx', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Audoli-Inthavong', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Sors', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lambert', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Wattez', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Dirk M', 'Initials': 'DM', 'LastName': 'Hermann', 'Affiliation': 'Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Electronic address: dirk.hermann@uk-essen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30004-1']
3246,32076564,Cost-utility analysis of learning and coping versus standard education in cardiac rehabilitation: a randomised controlled trial with 3 years of follow-up.,"Objectives


To enhance adherence to cardiac rehabilitation (CR), a patient education programme called 'learning and coping' (LC-programme) was implemented in three hospitals in Denmark. The aim of this study was to investigate the cost-utility of the LC-programme compared with the standard CR-programme.
Methods


825 patients with ischaemic heart disease or heart failure were randomised to the LC-programme or the standard CR-programme and were followed for 3 years.A societal cost perspective was applied and quality-adjusted life years (QALY) were based on SF-6D measurements. Multiple imputation technique was used to handle missing data on the SF-6D. The statistical analyses were based on means and bootstrapped SEs. Regression framework was employed to estimate the net benefit and to illustrate cost-effectiveness acceptability curves.
Results


No statistically significant differences were found between the two programmes in total societal costs (4353 Euros; 95% CI -3828 to 12 533) or in QALY (-0.006; 95% CI -0.053 to 0.042). At a threshold of 40 000 Euros, the LC-programme was found to be cost-effective at 15% probability; however, for patients with heart failure, due to increased cost savings, the probability of cost-effectiveness increased to 91%.
Conclusions


While the LC-programme did not appear to be cost-effective in CR, important heterogeneity was noted for subgroups of patients. The LC-programme was demonstrated to increase adherence to the rehabilitation programme and to be cost-effective among patients with heart failure. However, further research is needed to study the dynamic value of heterogeneity due to the small sample size in this subgroup.",2020,The LC-programme was demonstrated to increase adherence to the rehabilitation programme and to be cost-effective among patients with heart failure.,"['825 patients with ischaemic heart disease or heart failure', 'patients with heart failure', 'cardiac rehabilitation']","['learning and coping versus standard education', 'LC-programme or the standard CR-programme', ""cardiac rehabilitation (CR), a patient education programme called 'learning and coping' (LC-programme"", 'LC-programme']","['total societal costs', 'cost savings, the probability of cost-effectiveness', 'cost-utility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",825.0,0.0314959,The LC-programme was demonstrated to increase adherence to the rehabilitation programme and to be cost-effective among patients with heart failure.,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Tayyari Dehbarez', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Palmhøj Nielsen', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Bettine Wulff', 'Initials': 'BW', 'LastName': 'Risør', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vinther Nielsen', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Lynggaard', 'Affiliation': 'Department of Cardiology, Regional Hospital West Jutland, Herning, Denmark.'}]",Open heart,['10.1136/openhrt-2019-001184']
3247,32072749,Sex as a moderator of body composition following a randomized controlled lifestyle intervention among Latino youth with obesity.,"BACKGROUND


Body composition differences between males and females emerge during adolescence and continue throughout adulthood; however, whether sex moderates body composition changes in adolescents with obesity after an intervention is unknown.
OBJECTIVE


To examine sex as a moderator of changes in adiposity following lifestyle intervention.
METHODS


A total of 136 Latino youth with obesity (BMI% 98.2 ± 1.3) aged 14 to 16 years old were randomized to either a 12-week lifestyle intervention (27 males/40 females) or control (35 males/34 females) group. The intervention included nutrition education (1 h/wk) and moderate-to-vigorous physical activity (3 h/wk). Anthropometric data (body mass index [BMI], BMI%, waist circumference, total body fat, and fat-free mass) were obtained pre- and post-intervention. Sex differences were examined by general linear models with significance determined at P < .05 for the F-statistic.
RESULTS


Sex did not moderate changes in BMI (F 1,115  = 0.01, P = .9), BMI% (F 1,115  = 0.14, P = .7), or waist circumference (F 1,117  = 1.1, P = .3). Sex significantly moderated changes in body fat percent (F 1,117  = 5.3, P = .02), fat mass (F 1,116  = 4.5, P = .04), and fat-free mass (F 1,116  = 4.3, P = .04). Intervention males compared with females had greater relative reductions in fat percent (-4.1 ± 0.8% vs -1.2 ± 0.7%, P = .02) and fat mass (-5.0 ± 1.1 kg vs -1.5 ± 0.9 kg, P = .02) and gained more fat free mass (3.6 ± 0.9 kg vs 0.5 ± 0.8 kg, P = .02) when compared with same sex controls.
CONCLUSION


Males and females exhibited a differential response to lifestyle intervention for percent fat, fat mass, and fat-free mass indicating that sex-specific improvements in body composition favours males over females.",2020,"Sex significantly moderated changes in body fat percent (F 1,117  = 5.3, P = .02), fat mass (F 1,116  = 4.5, P = .04), and fat-free mass (F 1,116  = 4.3, P = .04).","['Latino youth with obesity', '136 Latino youth with obesity (BMI% 98.2\u2009±\u20091.3) aged 14 to 16\u2009years old', '27 males/40 females) or control (35 males/34 females) group']",['lifestyle intervention'],"['waist circumference', 'fat mass', 'fat-free mass', 'Anthropometric data (body mass index [BMI], BMI%, waist circumference, total body fat, and fat-free mass', 'BMI']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}]",136.0,0.0308452,"Sex significantly moderated changes in body fat percent (F 1,117  = 5.3, P = .02), fat mass (F 1,116  = 4.5, P = .04), and fat-free mass (F 1,116  = 4.3, P = .04).","[{'ForeName': 'Kiley B', 'Initials': 'KB', 'LastName': 'Vander Wyst', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Micah L', 'Initials': 'ML', 'LastName': 'Olson', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Colleen S', 'Initials': 'CS', 'LastName': 'Keller', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Erica G', 'Initials': 'EG', 'LastName': 'Soltero', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Williams', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Peña', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Jager', 'Affiliation': 'T. Denny Sanford School of Social and Family Dynamics, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Gabriel Q', 'Initials': 'GQ', 'LastName': 'Shaibi', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}]",Pediatric obesity,['10.1111/ijpo.12620']
3248,32080013,"Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial.","STUDY DESIGN


in the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial.
OBJECTIVE


The aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF).
SUMMARY OF BACKGROUND DATA


Spinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited.
METHODS


This study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI).
RESULTS


There were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).
CONCLUSION


The results of this noninferiority trial support the use of AttraX Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF.
LEVEL OF EVIDENCE


1.",2020,"The 90% CI around the difference in fusion performance excluded the non-inferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).
","['87 patients, including 146 instrumented segments', '49 males and 51 females with a mean age of 55.4\u200a±\u200a12.0 (range 27-79) years', '100 non-traumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF']","['biphasic calcium-phosphate (AttraX® Putty', 'Standalone Microporous Ceramic vs. Autograft', 'AttraX® Putty']","['fusion rate of AttraX® Putty', 'fusion performance excluded the non-inferiority margin', 'PLF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}]","[{'cui': 'C0210087', 'cui_str': 'biphasic calcium phosphate'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",100.0,0.253585,"The 90% CI around the difference in fusion performance excluded the non-inferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).
","[{'ForeName': 'A Mechteld', 'Initials': 'AM', 'LastName': 'Lehr', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F Cumhur', 'Initials': 'FC', 'LastName': 'Oner', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Diyar', 'Initials': 'D', 'LastName': 'Delawi', 'Affiliation': 'Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoebink', 'Affiliation': 'Department of Orthopaedic Surgery, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Diederik H R', 'Initials': 'DHR', 'LastName': 'Kempen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Job L C', 'Initials': 'JLC', 'LastName': 'van Susante', 'Affiliation': 'Department of Orthopaedic Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Moyo C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003440']
3249,32079912,Caffeine Optimizes HIIT Benefits on Obesity-associated Metabolic Adversity in Women.,"PURPOSE


We investigated whether obesity adversities such as excessive body fat, compensatory hyperinsulinemia, metabolic endotoxemia, irregular androgenicity, and reduced cardiorespiratory and anaerobic fitness are ameliorated by high-intensity interval training (HIIT) with or without caffeine supplementation in women with obesity.
METHODS


Twenty-four women with obesity (Asian cutoff point body mass index ≥ 27 kg·m, body fat = 40%) were evenly randomized to caffeine (CAF) and placebo (PLA) trials for an 8-wk HIIT program (10 × 1-min sprints, interspersed by 1-min rest). CAF (3 mg·kg·bw) and PLA were supplemented before each training session. Body fat was assessed by dual-energy x-ray absorptiometry before and after training together with assessments of glucose tolerance (oral glucose tolerance test, or OGTT), lipopolysaccharide endotoxins, testosterone, cardiorespiratory, and anaerobic fitness.
RESULTS


Significant interaction between HIIT and CAF was found for OGTT glucose and OGTT insulin levels (P = 0.001 and P = 0.049 respectively). HIIT-alone increased glucose at 90 min (P = 0.049) and OGTT insulin at 60 min (P = 0.038). Conversely, HIIT with CAF decreased OGTT glucose at 120 min (P = 0.024) without affecting OGTT insulin. HIIT-alone induced 28.3% higher OGTT insulin (effect size d = 0.59 for area under the curve) and 14.5% higher OGTT glucose (d = 0.28). Conversely, HIIT with CAF decreased OGTT glucose by 19.1% (d = 0.51 for area under the curve) without changing OGTT insulin. HIIT-alone effects on glycemia and insulinemia were concurrent with a 31% increase in lipopolysaccharide endotoxins (P = 0.07; d = 0.78; confidence interval, 5.7-8.7) in the PLA but not in CAF treatment (P = 0.99; d = 0.003; confidence interval, 6.5-10.6), although endotoxin level remained within the recommended healthy thresholds. Furthermore, either HIIT alone or with CAF reduced body fat percentage (P < 0.001, ANOVA main training effects), increased muscle mass (P = 0.002), reduced testosterone (P = 0.005), and increased cardiorespiratory and anaerobic capacity (P < 0.001).
CONCLUSIONS


HIIT induces fat loss and decreases androgenicity in women with obesity. However, its side effects such as endotoxemia and hyperinsulinemia are ameliorated by caffeine supplementation.",2020,HIIT-alone increased glucose at 90-min (p=0.049) and OGTT-insulin at 60-min (p=0.038).,"['Twenty-four women with obesity (Asian cut-off point BMI ≥ 27 kg.m, body fat=40', 'women with obesity', 'Women']","['caffeine (CAF) and placebo (PLA', 'Caffeine Optimizes HIIT', 'CAF', 'high-intensity interval training (HIIT) with or without caffeine supplementation']","['body fat percentage', 'lipopolysaccharide endotoxins', 'reduced testosterone', 'Body fat', 'glucose tolerance (OGTT), lipopolysaccharide endotoxins, testosterone, cardiorespiratory and anaerobic fitness', 'muscle mass', 'HIIT with CAF decreased OGTT-glucose', 'OGTT- glucose and insulin levels', 'glycemia and insulinemia', 'fat loss and decreases androgenicity', 'cardiorespiratory and anaerobic capacity (p<0.001', 'endotoxins level', 'endotoxemia and hyperinsulinemia']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}]",24.0,0.0238286,HIIT-alone increased glucose at 90-min (p=0.049) and OGTT-insulin at 60-min (p=0.038).,"[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alkhatib', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei City, Taiwan, REPUBLIC OF CHINA.'}, {'ForeName': 'Min-Jung', 'Initials': 'MJ', 'LastName': 'Hsieh', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei City, Taiwan, REPUBLIC OF CHINA.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei City, Taiwan, REPUBLIC OF CHINA.'}, {'ForeName': 'Chien-Wen', 'Initials': 'CW', 'LastName': 'Hou', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei City, Taiwan, REPUBLIC OF CHINA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002311']
3250,32072434,"Effects of dietary and physical activity interventions on generic and cancer-specific health-related quality of life, anxiety, and depression in colorectal cancer survivors: a randomized controlled trial.","PURPOSE


To assess the effects of dietary and physical activity (PA) interventions on generic and cancer-specific quality of life (QoL), anxiety, and depression levels among adult Chinese colorectal cancer (CRC) survivors.
METHODS


Two-hundred twenty-three adult CRC survivors within 1 year of completion of primary cancer treatment were randomized to receive dietary, PA or combined intervention, or usual care for a 12 monthduration, under a 2 (diet vs usual care) × 2 (PA vs usual care) factorial design. Generic and cancer-specific QoL was assessed using a Chinese version 12-Item Short Form Health Survey (SF-12) and the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale, respectively. Anxiety and depression was assessed using the Hospital Anxiety and Depression Scale at baseline, 6, 12, 18, and 24 months. Linear mixed models were used for examining the intervention effects.
RESULTS


Participants receiving dietary intervention experienced a significant improvement in the generic measure of QoL (SF-6D utility scores, mean difference 0.042, 95%CI 0.03 to 0.081) at 12 months, the cancer-specific QoL scores (mean difference 3.09, 95%CI 0.13 to 6.04), and levels of depression (P = 0.015) at both 12 and 24 months follow-up. Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.
CONCLUSIONS


Dietary intervention improved the generic and cancer-specific QoL and depression in CRC survivors.
TRIAL REGISTRATION


The study was prospectively registered on 17 October 2012 at ClinicalTrials.gov (NCT01708824).
IMPLICATIONS FOR CANCER SURVIVORS


CRC survivors can benefit from dietary interventions in alleviating depression and improving overall health-related QoL.",2020,"Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.
","['FOR CANCER SURVIVORS', 'Two-hundred twenty-three', 'CRC survivors', 'adult CRC survivors within 1\xa0year of completion of primary cancer treatment', 'colorectal cancer survivors', 'adult Chinese colorectal cancer (CRC) survivors']","['dietary and physical activity interventions', 'Dietary intervention', 'dietary and physical activity (PA) interventions', 'PA intervention', 'dietary intervention', 'dietary, PA or combined intervention, or usual care for a 12\xa0monthduration, under a 2 (diet vs usual care']","['Hospital Anxiety and Depression Scale', 'Anxiety and depression', 'generic and cancer-specific health-related quality of life, anxiety, and depression', 'generic measure of QoL (SF-6D utility scores', 'generic and cancer-specific QoL and depression', 'cancer-specific QoL scores', 'levels of depression', 'SF-6D utility index', 'physical functioning', 'generic and cancer-specific quality of life (QoL), anxiety, and depression levels', 'Generic and cancer-specific QoL', 'Chinese version 12-Item Short Form Health Survey (SF-12) and the Functional Assessment of Cancer Therapy-Colorectal']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}]",223.0,0.0960913,"Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.
","[{'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, The University of Hong Kong, 4/F William M.W. Mong Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Judy W C', 'Initials': 'JWC', 'LastName': 'Ho', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Daniel Y T', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, The University of Hong Kong, 4/F William M.W. Mong Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong. dytfong@hku.hk.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Lee', 'Affiliation': 'Centre for Sports and Exercise, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Duncan J', 'Initials': 'DJ', 'LastName': 'Macfarlane', 'Affiliation': 'Centre for Sports and Exercise, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'School of Public Health, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Antoinette M', 'Initials': 'AM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Sharron', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, Hong Kong Baptist Hospital, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Wynnie Y Y', 'Initials': 'WYY', 'LastName': 'Chan', 'Affiliation': 'School of Professional and Continuing Education, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Ivy P F', 'Initials': 'IPF', 'LastName': 'Leung', 'Affiliation': 'Department of Dietetics, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Sharon H S', 'Initials': 'SHS', 'LastName': 'Lam', 'Affiliation': 'Centre for Sports and Exercise, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Natural', 'Initials': 'N', 'LastName': 'Chu', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Aliki J', 'Initials': 'AJ', 'LastName': 'Taylor', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kar-Keung', 'Initials': 'KK', 'LastName': 'Cheng', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00864-0']
3251,31951270,Effect of a Mobile Monitoring System vs Usual Care on Depression Symptoms and Psychological Health: A Randomized Clinical Trial.,,2020,,[],['Mobile Monitoring System vs Usual Care'],['Depression Symptoms and Psychological Health'],[],"[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0952709,,"[{'ForeName': 'Skyler', 'Initials': 'S', 'LastName': 'Place', 'Affiliation': 'CompanionMX, Boston, Massachusetts.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Blanch-Hartigan', 'Affiliation': 'Department of Natural and Applied Sciences, Bentley University, Waltham, Massachusetts.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Smith', 'Affiliation': 'CompanionMX, Boston, Massachusetts.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Erb', 'Affiliation': ""Department of Psychiatry, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Marci', 'Affiliation': 'CompanionMX, Boston, Massachusetts.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Ahern', 'Affiliation': ""Program in Behavioral Informatics and eHealth, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.19403']
3252,32084035,Brain Connectivity Modulation After Exoskeleton-Assisted Gait in Chronic Hemiplegic Stroke Survivors: A Pilot Study.,"OBJECTIVE


The aim of this study was to investigate electroencephalographic (EEG) connectivity short-term changes, quantified by node strength and betweenness centrality, induced by a single trial of exoskeleton-assisted gait in chronic stroke survivors.
DESIGN


Study design was randomized crossover. Electroencephalographic data (64-channel system) were recorded before gait (baseline) and after unassisted overground walking and overground exoskeleton-assisted walking. Coherence was estimated for alpha1, alpha2, and beta frequency ranges. Graph analysis assessed network model properties: node strength and betweenness centrality.
RESULTS


Nine participants were included in the final analysis. In the group (four participants) with a left-hemisphere stroke lesion (dominant hemisphere), over the vertex, node strength increased in alpha1, alpha2, and beta bands, and betweenness centrality decreased in alpha2 both after unassisted overground walking and exoskeleton-assisted walking. In the group (five participants) with a right-hemisphere lesion (nondominant hemisphere), node strength increased in alpha1 and alpha2 over the contralesional sensorimotor area and ipsilesional prefrontal area after overground exoskeleton-assisted walking, compared with baseline and unassisted overground walking.
CONCLUSION


A single session of exoskeleton training provides short-term neuroplastic modulation in chronic stroke. In participants with a nondominant hemisphere lesion, exoskeleton training induces activations similar to those observed in able-bodied participants, suggesting a role of lesion lateralization in networks' reorganization.",2020,"In the group (5 participants) with a right-hemisphere lesion (non-dominant hemisphere), NS increased in alpha1 and alpha2 over the contralesional sensorimotor area and ipsilesional prefrontal area after EXO, compared to BL and UW","['chronic hemiplegic stroke survivors', 'chronic stroke survivors', 'Nine participants were included in final analysis', 'participants with a non-dominant hemisphere lesion', 'chronic stroke']","['exoskeleton assisted gait', 'exoskeleton training']","['node strength (NS) and betweenness centrality (BC', 'vertex NS increased in alpha1, alpha2 and beta bands, and BC']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}]",9.0,0.122839,"In the group (5 participants) with a right-hemisphere lesion (non-dominant hemisphere), NS increased in alpha1 and alpha2 over the contralesional sensorimotor area and ipsilesional prefrontal area after EXO, compared to BL and UW","[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Molteni', 'Affiliation': 'From the Valduce Hospital, Villa Beretta Rehabilitation Center, Costa Masnaga, Lecco (FM, EG); Department of Neuroscience, Section of Rehabilitation, University of Padova, Padova (EF, AB, SM, ADF); Fondazione Ospedale San Camillo IRCCS, Venice (FP); and Padova Neuroscience Center, University of Padova, Padova (SM, ADF), Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Formaggio', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bosco', 'Affiliation': ''}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Guanziroli', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Piccione', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Masiero', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Felice', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001395']
3253,32079914,Exercise Induces Different Molecular Responses in Trained and Untrained Human Muscle.,"INTRODUCTION


Human skeletal muscle is thought to have heightened sensitivity to exercise stimulus when it has been previously trained (i.e., it possesses ""muscle memory""). We investigated whether basal and acute resistance exercise-induced gene expression and cell signaling events are influenced by previous strength training history.
METHODS


Accordingly, 19 training naïve women and men completed 10 wk of unilateral leg strength training, followed by 20 wk of detraining. Subsequently, an acute resistance exercise session was performed for both legs, with vastus lateralis biopsies taken at rest and 1 h after exercise in both legs (memory and control).
RESULTS


The phosphorylation of AMPK and eEF2 was higher in the memory leg than that in the control leg at both time points. The postexercise phosphorylation of 4E-BP1 was higher in the memory leg than that in the control leg. The memory leg had lower basal mRNA levels of total PGC1α and, unlike the control leg, exhibited increases in PGC1α-ex1a transcripts after exercise. In the genes related to myogenesis (SETD3, MYOD1, and MYOG), mRNA levels differed between the memory and the untrained leg; these effects were evident primarily in the male subjects. Expression of the novel gene SPRYD7 was lower in the memory leg at rest and decreased after exercise only in the control leg, but SPRYD7 protein levels were higher in the memory leg.
CONCLUSION


In conclusion, several key regulatory genes and proteins involved in muscular adaptations to resistance exercise are influenced by previous training history. Although the relevance and mechanistic explanation for these findings need further investigation, they support the view of a molecular muscle memory in response to training.",2020,The phosphorylation of AMPK and eEF2 was higher in the memory leg than in the control leg at both time points.,"['19 training naïve women and men completed 10 weeks of', 'Trained and Untrained Human Muscle']",['unilateral leg strength training'],"['myogenesis (SETD3, MYOD1, and MYOG), mRNA levels', 'phosphorylation of AMPK and eEF2', '4E-BP1', 'PGC1α-ex1a transcripts']","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0596997', 'cui_str': 'Myogenesis'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}]",,0.0219567,The phosphorylation of AMPK and eEF2 was higher in the memory leg than in the control leg at both time points.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Åstrand Laboratory, Swedish School of Sport and Health Sciences, Stockholm, SWEDEN.'}, {'ForeName': 'Malene E', 'Initials': 'ME', 'LastName': 'Lindholm', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, SWEDEN.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Reitzner', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, SWEDEN.'}, {'ForeName': 'BjÖrn', 'Initials': 'B', 'LastName': 'Ekblom', 'Affiliation': 'Åstrand Laboratory, Swedish School of Sport and Health Sciences, Stockholm, SWEDEN.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Sundberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, SWEDEN.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Psilander', 'Affiliation': 'Åstrand Laboratory, Swedish School of Sport and Health Sciences, Stockholm, SWEDEN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002310']
3254,32079916,Leucine Supplementation Has No Further Effect on Training-induced Muscle Adaptations.,"INTRODUCTION


Several acute studies have suggested that leucine is a key amino acid to drive muscle protein synthesis. However, there are very few studies on the long-term effects of leucine supplementation on resistance training (RT)-induced gains in muscle mass and strength. We sought to determine the impact of 10 g of leucine on muscle mass and strength in response to RT in healthy young men.
METHODS


Twenty-five, resistance-trained men (27 ± 5 yr; 78.4 ± 11.6 kg; 24.8 ± 3.0 kg·m) consuming 1.8 ± 0.4 g protein·kg·d, were randomly assigned to receive 2 × 5 g·d supplementation of either free leucine (LEU n = 12) or alanine (PLA n = 13) while undergoing a supervised 12-wk, twice-weekly lower-limb RT program. One-repetition maximum (leg-press 1RM) and muscle cross-sectional area (mCSA) of the vastus lateralis were determined before (PRE) and after (POST) the intervention. Additionally, three 24-h dietary recalls were also performed at PRE and POST.
RESULTS


Protein intake was roughly double that of the RDA in both groups and remained unchanged across time with no differences detected between groups. Similar increases were observed between groups in leg-press 1RM (LEU, 19.0% ± 9.4% and PLA, 21.0% ± 10.4%, P = 0.31) and mCSA (LEU, 8.0% ± 5.6% and PLA, 8.4% ± 5.1%, P = 0.77).
CONCLUSIONS


High-dose leucine supplementation did not enhance gains in muscle strength and mass after a 12-wk RT program in young resistance-trained males consuming adequate amounts of dietary protein.",2020,"RESULTS


Protein intake was roughly double that of the RDA in both groups and remained unchanged across time with no differences detected between groups.","['Twenty-five, resistance-trained men (27 ± 5 y; 78.4 ± 11.6 kg; 24.8 ± 3.0 kg/m) consuming 1.8 ± 0.4 g protein·kg·d', 'healthy young men']","['resistance training (RT', '2 x 5 g·d supplementation of either free leucine (LEU n=12) or alanine (PLA n= 13), while undergoing a supervised 12-week, twice- weekly lower-limb RT program', 'Leucine Supplementation', 'leucine supplementation', 'leucine']",[],"[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0283281,"RESULTS


Protein intake was roughly double that of the RDA in both groups and remained unchanged across time with no differences detected between groups.","[{'ForeName': 'Isabel Thomazi', 'Initials': 'IT', 'LastName': 'DE Andrade', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hevia-LarraÍn', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Juarez', 'Initials': 'J', 'LastName': 'Neves-Junior', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Cajueiro', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Jardim', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Rodrigo Leite', 'Initials': 'RL', 'LastName': 'Gomes', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Guilherme Giannini', 'Initials': 'GG', 'LastName': 'Artioli', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, CANADA.'}, {'ForeName': 'PatrÍcia', 'Initials': 'P', 'LastName': 'Campos-Ferraz', 'Affiliation': 'Faculty of Applied Sciences, University of Campinas, Limeira, São Paulo, BRAZIL.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology and Nutrition Research Group, University of São Paulo, São Paulo, BRAZIL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002307']
3255,32079920,Addition of an Alginate Hydrogel to a Carbohydrate Beverage Enhances Gastric Emptying.,"PURPOSE


This study aimed to examine the effect of altering osmolality or adding sodium alginate and pectin to a concentrated carbohydrate (CHO) beverage on gastric-emptying (GE) rate.
METHODS


Boluses (500 mL) of three drinks were instilled double blind in eight healthy men while seated, GE was measured using the double sampling method for 90 min, and blood samples were collected regularly. Drinks consisted of glucose and fructose (MON; 1392 mOsmol·kg), maltodextrin and fructose (POLY; 727 mOsmol·kg), and maltodextrin, fructose, sodium alginate, and pectin (ENCAP; 732 mOsmol·kg) with each providing 180 g·L CHO (CHO ratio of 1:0.7 maltodextrin or glucose/fructose).
RESULTS


Time to empty half of the ingested bolus was faster for ENCAP (21 ± 9 min) than for POLY (37 ± 8 min); both were faster than MON (51 ± 15 min). There were main effects for time and drink in addition to an interaction effect for the volume of test drink remaining in the stomach over the 90 min period, but there were no differences between MON and POLY at any time point. ENCAP had a smaller volume of the test drink in the stomach than MON at 30 min (193 ± 62 vs 323 ± 54 mL), which remained less up to 60 min (93 ± 37 vs 210 ± 88 mL). There was a smaller volume of the drink remaining in the stomach in ENCAP compared with POLY 20 min (242 ± 73 vs 318 ± 47 mL) and 30 min (193 ± 62 vs 304 ± 40 mL) after ingestion. Although there was a main effect of time, there was no effect of drink or an interaction effect on serum glucose, insulin or nonesterified fatty acid concentrations.
CONCLUSION


The addition of sodium alginate and pectin to a CHO beverage enhances early GE rate but did not affect serum glucose, insulin, or nonesterified fatty acid concentration at rest.",2020,"to empty half of the ingested bolus was faster for ENCAP (21±9 min) than POLY (37±8 min), both were faster than MON (51±15 min).",[],"['ENCAP', 'sodium alginate and pectin to a CHO beverage', 'glucose and fructose (MON, 1392 mOsmol/kg), maltodextrin and fructose (POLY, 727 mOsmol/kg) and maltodextrin, fructose, sodium alginate and pectin (ENCAP, 732 mOsmol/kg) with each providing 180 g/L CHO (CHO ratio of 1:0.7 maltodextrin/glucose:fructose', 'sodium alginate and pectin to a concentrated carbohydrate (CHO) beverage']","['enhances early GE rate', 'gastric emptying (GE) rate', 'serum glucose, insulin or NEFA concentration', 'serum glucose, insulin or non-esterified fatty acid (NEFA) concentrations', 'Gastric Emptying']",[],"[{'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0070203', 'cui_str': 'pectin'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0439353', 'cui_str': 'mosmol/kg'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}]",8.0,0.117755,"to empty half of the ingested bolus was faster for ENCAP (21±9 min) than POLY (37±8 min), both were faster than MON (51±15 min).","[{'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Sutehall', 'Affiliation': 'Division of Exercise Science and Sports Medicine, University of Cape Town, Cape Town, SOUTH AFRICA.'}, {'ForeName': 'Stuart D R', 'Initials': 'SDR', 'LastName': 'Galloway', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UNITED KINGDOM.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Division of Exercise Science and Sports Medicine, University of Cape Town, Cape Town, SOUTH AFRICA.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Pitsiladis', 'Affiliation': 'Collaborating Centre of Sports Medicine, University of Brighton, Eastbourne, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002301']
3256,32079922,Sitting-induced Endothelial Dysfunction Is Prevented in Endurance-trained Individuals.,"PURPOSE


Prolonged sitting impairs leg endothelial function, which seems to be mediated by a sustained reduction in blood flow-induced shear stress. However, whether regular endurance training is effective in preventing sitting-induced leg endothelial dysfunction remains largely unknown. Herein, we tested the hypothesis that sitting-induced leg endothelial dysfunction is prevented in high endurance-trained individuals.
METHODS


The endurance-trained group comprised 10 male collegiate cyclists, and the untrained group comprised nine men with no regular endurance training. Peak oxygen uptake (V˙O2peak) was initially determined in all participants using incremental exercise test (37.9 ± 4.7 mL·min·kg in the untrained group versus 60.8 ± 3.6 mL·min·kg in the endurance-trained group). At second visit, the popliteal artery flow-mediated dilation (%FMD) was assessed before and after a 3-h sitting period. During the sitting period, the popliteal artery diameter and blood velocity were measured every hour.
RESULTS


The popliteal artery blood flow and shear rate were significantly and similarly reduced during the sitting period in both groups (P < 0.001). In a 3-h sitting, a significant impairment in popliteal artery %FMD was observed in the untrained group (P = 0.003), but it was prevented in the endurance-trained group (P < 0.196).
CONCLUSIONS


In conclusion, the present study revealed that sitting-induced leg endothelial dysfunction is preventable in endurance-trained individuals.",2020,The popliteal artery blood flow and shear rate were significantly and similarly reduced during the sitting period in both groups (P < 0.001).,"['Endurance-trained Individuals', 'endurance-trained individuals', 'high endurance-trained individuals']","['endurance-trained group comprised 10 male collegiate cyclists, and the untrained group comprised 9 male with no regular endurance training', 'regular endurance training']","['popliteal artery diameter and blood velocity', 'popliteal artery flow-mediated dilation (%FMD', 'popliteal artery %FMD', 'popliteal artery blood flow and shear rate', 'Peak oxygen uptake (VO2peak', 'leg endothelial dysfunction']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0032649', 'cui_str': 'Popliteal Artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",10.0,0.0295749,The popliteal artery blood flow and shear rate were significantly and similarly reduced during the sitting period in both groups (P < 0.001).,"[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Morishima', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, JAPAN.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Faculty of Modern Life, Teikyo Heisei University, Tokyo, JAPAN.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Ueda', 'Affiliation': 'Faculty of Health and Medical Science, Teikyo Heisei University, Chiba, JAPAN.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Tsuji', 'Affiliation': 'Center for Public Health Science, National Cancer Center, Tokyo, JAPAN.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ochi', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, JAPAN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002302']
3257,31741168,A randomized trial comparing health-related quality-of-life and utility measures between routine fine-needle aspiration cytology (FNAC) and surveillance alone in patients with thyroid incidentaloma measuring 1-2 cm.,"PURPOSE


To present the impact of treatment on health-related quality-of-life (HRQOL) and health utility measures from the randomized controlled trial (ClinicalTrials.gov Identifier: NCT02398721) that investigated the FNAC versus watchful surveillance in patients with incidental benign thyroid nodules.
METHODS


Health utility and HRQOL were evaluated using the EQ-5D 5-level (EQ-5D-5L), 6-item Short-Form Health Survey (SF-6D), and generic 12-item Short-Form Health Survey (SF-12v2) at baseline, 3-month, 6-month, and 12-month assessments. A repeated measure analysis of variance evaluated differences in HRQOL scores between treatment groups over time. Multiple imputations were used to impute missing data at each time point.
RESULTS


HRQOL data completion rates were 99.7% at baseline, 92.7% at 3-month, 93.9% at 6-month, 92.7% at 12-month, and 88.6% at 18-month follow-up after baseline. There were significant mean differences in SF-6D, EQ-5D-5L, and SF-12v2 over time except the domain of vitality and mental health of SF-12v2. Mean change of SF-12v2 scores and utility scores from baseline between groups did not exceed minimal important difference. No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 (p value = 0.033; 0.024).
CONCLUSIONS


When compared with watchful surveillance, FNAC intervention was associated with better vitality and physical-related HRQOL scores but did not provide better preservation of utility score improvement over the 18-month period. These findings support the routine FNAC approach for nodules that have a low-suspicion sonographic pattern and measure between 1.0 and 2.0 cm.",2020,"No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 (p value = 0.033; 0.024).
","['patients with incidental benign thyroid nodules', 'patients with thyroid incidentaloma measuring 1-2\u2009cm']","['FNAC', 'routine fine-needle aspiration cytology (FNAC']","['HRQOL scores', 'EQ-5D 5-level (EQ-5D-5L), 6-item Short-Form Health Survey (SF-6D), and generic 12-item Short-Form Health Survey (SF-12v2', 'vitality domain and PCS of SF-12v2', 'HRQOL data completion rates', 'health-related quality-of-life (HRQOL) and health utility measures', 'Mean change of SF-12v2 scores and utility scores', 'better vitality and physical-related HRQOL scores', 'SF-6D, EQ-5D-5L, and SF-12v2 over time except the domain of vitality and mental health of SF-12v2', 'HRQOL and utility scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0749467', 'cui_str': 'Benign thyroid nodule'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}, {'cui': 'C0010820', 'cui_str': 'cytology'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0837596,"No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 (p value = 0.033; 0.024).
","[{'ForeName': 'Carlos K H', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Rm 1-01, 1/F, Jockey Club Building for Interdisciplinary Research, 5 Sassoon Road, Pokfulam, Hong Kong SAR, China. carlosho@hku.hk.'}, {'ForeName': 'Brian H H', 'Initials': 'BHH', 'LastName': 'Lang', 'Affiliation': 'Division of Endocrine Surgery, Department of Surgery, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}]",Endocrine,['10.1007/s12020-019-02129-y']
3258,31375873,Concomitant transobturator tape and anterior colporrhaphy versus transobturator subvesical mesh for cystocele-associated stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS


Stress urinary incontinence (SUI) and cystocele often occur concomitantly and thus may potentially be treated via a single surgical procedure. This study evaluated the efficacy and safety of concomitant transobturator tape (TOT) with anterior colporrhaphy versus subvesical transobturator mesh (TOM) for cystocele-associated SUI.
METHODS


This prospective, clinical trial included women with cystocele-associated SUI. Patients were randomly allocated into either group I (anterior colporrhaphy with concomitant TOT ""in-out"" fixation) or group II (implantation of a subvesical four-armed TOM). All patients were followed up at 1, 3, 6, 9, and 12 months postoperatively. Statistical tests were performed to compare the group outcomes based on objective, subjective, and anatomical variables.
RESULTS


There were 81 patients in group I and 83 in group II. Median follow-up duration was 12 months. The demographic data and baseline clinical characteristics of both groups were comparable. There were no significant differences between groups regarding the success rates of SUI and cystocele repair. Groups I and II had similar cure rates of SUI (82.9 and 88.4%, respectively; p = 0.369) and incidences of successful cystocele repair (85.4 and 97.7%, respectively; p = 0.055). No urethral or bladder injuries or mesh erosions were reported. Both groups had comparable postoperative complications, except the greater incidence of micturition difficulty in group I than group II, during the early follow-up (12.2% vs. 0.0%; p = 0.024).
CONCLUSIONS


Transvaginal mesh was not superior to native tissue repair. Anterior colporrhaphy and TOT may be an appropriate alternative to four-armed TOM application for concomitant correction of SUI and cystocele.",2020,"Both groups had comparable postoperative complications, except the greater incidence of micturition difficulty in group I than group II, during the early follow-up (12.2% vs. 0.0%; p = 0.024).
",['women with cystocele-associated SUI'],"['Anterior colporrhaphy and TOT', 'Concomitant transobturator tape and anterior colporrhaphy versus transobturator subvesical mesh', 'concomitant transobturator tape (TOT) with anterior colporrhaphy versus subvesical transobturator mesh (TOM', 'group I (anterior colporrhaphy with concomitant TOT ""in-out"" fixation) or group II (implantation of a subvesical four-armed TOM']","['postoperative complications', 'incidence of micturition difficulty', 'success rates of SUI and cystocele repair', 'objective, subjective, and anatomical variables', 'incidences of successful cystocele repair', 'efficacy and safety', 'cure rates of SUI', 'urethral or bladder injuries or mesh erosions']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1394494', 'cui_str': 'Bladder cystocele'}]","[{'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy (procedure)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1721084', 'cui_str': 'Transobturator Suburethral Tape'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1261300', 'cui_str': 'Repair of cystocele (procedure)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C0403677', 'cui_str': 'Injury of bladder (disorder)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}]",81.0,0.025234,"Both groups had comparable postoperative complications, except the greater incidence of micturition difficulty in group I than group II, during the early follow-up (12.2% vs. 0.0%; p = 0.024).
","[{'ForeName': 'Abul-Fotouh A', 'Initials': 'AA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt. abulfotouhahmed@yahoo.com.'}, {'ForeName': 'Ashraf H', 'Initials': 'AH', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Hesham A', 'Initials': 'HA', 'LastName': 'El-Helaly', 'Affiliation': 'Department of Urology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Ibrahim A', 'Initials': 'IA', 'LastName': 'Tagreda', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'El-Feky', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Agha', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Abdelraouf', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Abdelrahim', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}]",International urogynecology journal,['10.1007/s00192-019-04068-8']
3259,31375458,Prediction of maximum oxygen uptake through incremental exercise testing using ventilometry: a cross-sectional study.,"BACKGROUND


Cardiopulmonary exercise testing is the main tool assessing cardiorespiratory fitness. However, cardiopulmonary exercise testing devices are expensive and often cannot be used.
OBJECTIVE


The present study sought to develop cardiopulmonary exercise testing equations for estimating maximum oxygen uptake from ergometric testing combined with ventilometry.
METHODS


181 volunteers of both sexes were submitted to cardiopulmonary exercise testing on treadmill using an incremental protocol. Volunteers were randomized into two groups: regression group: composed of 68 women with age 24.7±6.0 years and 54 men aged 21.5±3.9 years; and a cross-validation group composed of 29 women with mean age of 23.8±4.7 years and 30 men with a mean age of 23.1±4.4 years. The estimating equations were developed using multiple stepwise linear regressions; comparison of means was done using a t test and reliability assessed by Cronbach's alpha.
RESULTS


8 independent variables exhibited a significant result for estimating VO 2max : minute ventilation (E) at second ventilatory threshold (VT-II): (E _VT-II); heart rate at VT-II (HR_VT-II); body mass (BM); body mass index (BMI); fat percentage (F%); age; sex; velocity at VT-II (Vel_VT-II); test time of VT-II (T_VT-II) and final test velocity (Vel final ). Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
CONCLUSION


The present study demonstrated that the use of parameters collected during maximal ergometric test combined with ventilometry, improved the accuracy of equations for estimating maximum oxygen uptake.",2020,"Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
","['181 volunteers of both sexes', '68 women with age 24.7±6.0 years end 54 men aged 21.5±3.9 years; and cross-validation group: was composed 29 women with mean age 23.8±4.7 years and 30 men with mean 23.1±4.4 years']","['incremental exercise testing using ventilometry', 'Cardiopulmonary exercise testing on treadmill using an incremental protocol', 'Cardiopulmonary exercise testing equations']",['estimating VO 2max : minute ventilation (E) at second ventilatory threshold (VT-II): (E _VT-II); heart rate at VT-II (HR_VT-II); body mass (BM); body mass index (BMI); fat percentage (F%); age; sex; velocity at VT-II (Vel_VT-II); test time of VT-II (T_VT-II) and final test velocity (Vel final '],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0429928', 'cui_str': 'Test time (observable entity)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",181.0,0.0202251,"Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Policarpo Barbosa', 'Affiliation': 'Laboratory of Human Movement Biosciences, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil. Electronic address: fernandopolicarpo65@gmail.com.'}, {'ForeName': 'Paulo Eugênio', 'Initials': 'PE', 'LastName': 'Silva', 'Affiliation': 'Post-Graduate Program in Science and Technology in Health, Universidade de Brasília (UnB), Brasília, DF, Brazil.'}, {'ForeName': 'Andréa Carmen', 'Initials': 'AC', 'LastName': 'Guimarães', 'Affiliation': 'Laboratory of Human Movement Biosciences, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil; Department of Physical Education and Health Sciences, Universidade Federal de São João Del-Rei (UFSJ), São João del Rei, MG, Brazil.'}, {'ForeName': 'Carlos Soares', 'Initials': 'CS', 'LastName': 'Pernambuco', 'Affiliation': ""Doctor's Degree Program in Nursing and Biosciences - PPgEnfBio, Federal University of the State of Rio de Janeiro - UNIRIO, Rio de Janeiro, Brazil; Master and Doctor's Degree Program in Health and Environment - PSA, Tiradentes University - UNIT, Aracaju, Brazil.""}, {'ForeName': 'Estélio Henrique', 'Initials': 'EH', 'LastName': 'Dantas', 'Affiliation': ""Doctor's Degree Program in Nursing and Biosciences - PPgEnfBio, Federal University of the State of Rio de Janeiro - UNIRIO, Rio de Janeiro, Brazil; College of Physical Education, Universidade Tiradentes, Aracajú, SE, Brazil.""}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.002']
3260,32032355,The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial.,"BACKGROUND


Assessing genetic lifetime risk for prostate cancer has been proposed as a means of risk stratification to identify those for whom prostate-specific antigen (PSA) testing is likely to be most valuable. This project aimed to test the effect of introducing a genetic test for lifetime risk of prostate cancer in general practice on future PSA testing.
METHODS AND FINDINGS


We performed a cluster randomized controlled trial with randomization at the level of general practices (73 in each of two arms) in the Central Region (Region Midtjylland) of Denmark. In intervention practices, men were offered a genetic test (based on genotyping of 33 risk-associated single nucleotide polymorphisms) in addition to the standard PSA test that informed them about lifetime genetic risk of prostate cancer and distinguished between ""normal"" and ""high"" risk. The primary outcome was the proportion of men having a repeated PSA test within 2 years. A multilevel logistic regression model was used to test the association. After applying the exclusion criteria, 3,558 men were recruited in intervention practices, with 1,235 (34.7%) receiving the genetic test, and 4,242 men were recruited in control practices. Men with high genetic risk had a higher propensity for repeated PSA testing within 2 years than men with normal genetic risk (odds ratio [OR] = 8.94, p < 0.01). The study was conducted in routine practice and had some selection bias, which is evidenced by the relatively large proportion of younger and higher income participants taking the genetic test.
CONCLUSIONS


Providing general practitioners (GPs) with access to a genetic test to assess lifetime risk of prostate cancer did not reduce the overall number of future PSA tests. However, among men who had a genetic test, knowledge of genetic risk significantly influenced future PSA testing.
TRIAL REGISTRATION


This study is registered with ClinicalTrials.gov, number NCT01739062.",2020,"Men with high genetic risk had a higher propensity for repeated PSA testing within 2 years than men with normal genetic risk (odds ratio [OR] = 8.94, p < 0.01).","['Men with high genetic risk', '3,558 men were recruited in intervention practices, with 1,235 (34.7%) receiving the genetic test, and 4,242 men were recruited in control practices', 'primary care', 'general practices (73 in each of two arms) in the Central Region (Region Midtjylland) of Denmark']",[],['proportion of men having a repeated PSA test'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0454907', 'cui_str': 'Central region (geographic location)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]",4242.0,0.223805,"Men with high genetic risk had a higher propensity for repeated PSA testing within 2 years than men with normal genetic risk (odds ratio [OR] = 8.94, p < 0.01).","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Fredsøe', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Koetsenruyter', 'Affiliation': 'Research Unit for General Practice, The Research Centre for Cancer Diagnosis in Primary Care (Cap), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vedsted', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kirkegaard', 'Affiliation': 'Department of Public Health, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Væth', 'Affiliation': 'Department of Public Health, Section of Biostatistics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Torben F', 'Initials': 'TF', 'LastName': 'Ørntoft', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Karina D', 'Initials': 'KD', 'LastName': 'Sørensen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Bro', 'Affiliation': 'Research Unit for General Practice, The Research Centre for Cancer Diagnosis in Primary Care (Cap), Aarhus University, Aarhus, Denmark.'}]",PLoS medicine,['10.1371/journal.pmed.1003033']
3261,31367914,"Efficacy of F-100, diluted F-100, and infant formula as rehabilitation diet for infants aged < 6 months with severe acute malnutrition: a randomized clinical trial.","PURPOSE


To assess the efficacy and safety of F-100, diluted F-100 (F100D), and infant formula (IF) for dietary management in the rehabilitation phase of severe acute malnutrition (SAM) of infants aged under 6 months (u6m).
METHODS


Double-blind randomized clinical trial was conducted to assess the efficacy and safety of F-100, F-100D, and IF at the Nutrition Rehabilitation Unit, icddr,b. Infants (n = 153) u6m with SAM were enrolled and randomly assigned to any of the three diets after stabilization. Two ml blood was collected on study days 1, 3, and 7 for measuring serum electrolytes, creatinine and osmolality, urine samples for specific gravity and osmolality creatinine ratio. Renal Solute Load (RSL) and Potential Renal Solute Load (PRSL) were calculated. Infants were discharged when gained 15% of the admission bodyweight or had edema-free weight-for-length Z-score ≥ - 2.
RESULTS


Infants fed F-100 and F-100D had higher weight gain than infants who received IF. Mean difference between F-100 and IF was 4.6 g/kg/d (95% CI 1.5-7.6, P = 0.004) and between F-100D and IF was 3.1 g/kg/d (95% CI 0.6-5.5, P = 0.015). Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case). RSL was highest in infants fed F-100 but serum sodium showed no sign of elevation. Urinary specific gravity and serum sodium values were within normal range.
CONCLUSIONS


F-100 can be safely used in the rehabilitation phase for infants  u6m with SAM and there is no need to prepare alternative formulations.",2020,Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case).,"['severe acute malnutrition (SAM) of infants aged under 6\xa0months\xa0(u6m', 'infants aged\u2009<\u20096\xa0months with severe acute malnutrition', '153) u6m\xa0with SAM', 'Infants (n\u2009', 'infants']","['F-100, diluted F-100, and infant formula as rehabilitation diet', 'F-100, diluted F-100 (F100D), and infant formula (IF) for dietary management']","['RSL', 'Urinary specific gravity and serum sodium values', 'serum electrolytes, creatinine and osmolality, urine samples for specific gravity and osmolality creatinine ratio', 'efficacy and safety of F-100, F-100D, and IF', 'weight gain', 'Renal Solute Load (RSL) and Potential Renal Solute Load (PRSL', 'Total energy intake']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0037786', 'cui_str': 'Relative Density'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",,0.242064,Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case).,"[{'ForeName': 'M Munirul', 'Initials': 'MM', 'LastName': 'Islam', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh. mislam@icddrb.org.'}, {'ForeName': 'Sayeeda', 'Initials': 'S', 'LastName': 'Huq', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Md Iqbal', 'Initials': 'MI', 'LastName': 'Hossain', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh.'}, {'ForeName': 'A M Shamsir', 'Initials': 'AMS', 'LastName': 'Ahmed', 'Affiliation': 'Primary Health Tasmania, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashworth', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Md Abid Hossain', 'Initials': 'MAH', 'LastName': 'Mollah', 'Affiliation': 'Department of Paediatrics, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM), Dhaka, 1000, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh.'}]",European journal of nutrition,['10.1007/s00394-019-02067-5']
3262,32061571,The effects of silicone-based resilient denture liners on pain: A randomized controlled trial.,"PURPOSE


This randomized controlled trial aimed to study the effects of lining mandibular complete dentures with silicone-based resilient denture liners, especially with respect to sensation.
METHODS


The trial included completely edentulous patients who were willing to fabricate new set of complete denture. A random permuted block method (block size: 4) was used to assign participants to one of the following groups: mandibular conventional denture (CD) group or mandibular denture with resilient denture liner (RD) group. The outcomes were evaluated using both, objective measures (current perception threshold (CPT) and pain threshold (PT)) for external stimuli measured using the Neurometer CPT® and subjective measures (physical pain and psychological discomfort measured using the Japanese version of Oral Health Impact Profile for Edentulous patients-OHIP-EDENT-J). The outcomes were measured twice, at immediately after completion of denture adjustments (first measurement), and 3 months after the completion of denture adjustments (second measurement). All outcomes were analyzed using the Student t-test. A p-value of <0.05 was considered statistically significant.
RESULTS


CPT was significantly higher with RD than CD only at second measurement with frequency level of 2000 Hz and 5 Hz. The pain thresholds were significantly higher in the RD group than the CD group. The physical pain and psychological discomfort scores were significantly lower in the RD group than in the CD group.
CONCLUSION


This study concludes that edentulous patients wearing mandibular complete dentures with silicone-based resilient denture liners dull perception mandibular ridge mucosa and felt less pain than those without the liners.",2020,"The physical pain and psychological discomfort scores were significantly lower in the RD group than in the CD group.
","['edentulous patients wearing mandibular complete dentures with silicone-based resilient denture liners dull perception mandibular ridge mucosa and felt less pain than those without the liners', 'edentulous patients who were willing to fabricate new set of complete denture']","['mandibular conventional denture (CD) group or mandibular denture with resilient denture liner (RD', 'silicone-based resilient denture liners', 'lining mandibular complete dentures with silicone-based resilient denture liners']","['pain thresholds', 'physical pain and psychological discomfort scores', 'pain', 'objective measures (current perception threshold (CPT) and pain threshold (PT)) for external stimuli measured using the Neurometer CPT® and subjective measures (physical pain and psychological discomfort measured using the Japanese version of Oral Health Impact Profile']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011450', 'cui_str': 'Cushion Liners'}, {'cui': 'C0443208', 'cui_str': 'Dull (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0457285', 'cui_str': 'Conventional denture (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0011450', 'cui_str': 'Cushion Liners'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}]","[{'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0029162'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.0736263,"The physical pain and psychological discomfort scores were significantly lower in the RD group than in the CD group.
","[{'ForeName': 'So', 'Initials': 'S', 'LastName': 'Furokawa', 'Affiliation': 'Nihon University Graduate School of Dentistry at Matsudo, Removable Prosthodontics, Matsudo, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan. Electronic address: kimoto.suguru@nihon-u.ac.jp.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Furuse', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Furuya', 'Affiliation': 'Nihon University Graduate School of Dentistry at Matsudo, Removable Prosthodontics, Matsudo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Okubo', 'Affiliation': 'Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, Matsudo, 2-870-1 Sakaecho-nishi, Chiba 271-8587, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Dentistry at Matsudo, Matsudo, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'Nihon University Graduate School of Dentistry at Matsudo, Removable Prosthodontics, Matsudo, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.11.006']
3263,31993789,Prone single-position extreme lateral interbody fusion (Pro-XLIF): preliminary results.,"BACKGROUND


Single-position options for combined anterior and posterior fusion in the lumbar spine have been suggested to reduce the surgical time and improve the efficiency of operating room. Previous reports have focused on lateral decubitus single-position surgery. The goal of this study is to describe and evaluate the feasibility and safety of prone single-position extreme lateral interbody fusion (XLIF) with posterior fixation.
METHODS


Design Pilot prospective non-randomized controlled study. Seven patients who underwent prone single-position XLIF and posterior fixation were evaluated (Pro-XLIF). A control group (Std-XLIF) was composed of ten patients who underwent XLIF in lateral decubitus and posterior fixation in prone position. All patients underwent interbody XLIF fusion at one level and posterior procedures at one or more levels. Duration of surgery, blood loss, complications, X-ray use and clinical outcomes were recorded.
RESULTS


No major complications were observed in either group. Oswestry Disability Index, back pain and leg pain were improved in the Pro-XLIF group from 48.5, 7.7 and 8.5 to 14.5, 1.71 and 2.71, respectively, and in the Std-XLIF group from 50.8, 5.7 and 7.2 to 22.5, 3.7 and 2.5. The Pro-XLIF group had a longer time of preparation before incision (39 vs 26 min, ns), equal duration of the anterior procedure (65 vs 59 min, ns), shorter duration of surgery (133 vs 182 min, ns) and longer X-ray exposure time (102 vs 92 s, ns). The surgical technique is described.
CONCLUSIONS


Prone single-position XLIF is feasible and safe. In this preliminary report, the results are comparable to the standard technique. These slides can be retrieved under Electronic Supplementary Material.",2020,"The Pro-XLIF group had a longer time of preparation before incision (39 vs 26 min, ns), equal duration of the anterior procedure (65 vs 59 min, ns), shorter duration of surgery (133 vs 182 min, ns) and longer X-ray exposure time (102 vs 92 s, ns).",[],"['prone single-position extreme lateral interbody fusion (XLIF) with posterior fixation', 'Prone single-position extreme lateral interbody fusion (Pro-XLIF', 'XLIF']","['shorter duration of surgery', 'Duration of surgery, blood loss, complications, X-ray use and clinical outcomes', 'longer X-ray exposure time', 'major complications', 'longer time of preparation before incision', 'Oswestry Disability Index, back pain and leg pain']",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}]",7.0,0.0424682,"The Pro-XLIF group had a longer time of preparation before incision (39 vs 26 min, ns), equal duration of the anterior procedure (65 vs 59 min, ns), shorter duration of surgery (133 vs 182 min, ns) and longer X-ray exposure time (102 vs 92 s, ns).","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lamartina', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Berjano', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy. pberjano@gmail.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06303-z']
3264,32061042,An evaluation of a psychoeducation programme for emotion identification and expression in individuals diagnosed with schizophrenia.,"The inability of individuals diagnosed with schizophrenia to recognize facial expressions is an important issue that has an impact on social functioning. This study was conducted to determine the effects of a psychoeducation programme for emotion identification and expression in those diagnosed with schizophrenia on their ability to identify and discriminate between emotions and social functionality. This quasi-experimental study (pretest-post-test, with control group) comprised an intervention (21) and a control (21) group conducted with individuals diagnosed with schizophrenia. A 10-week psychoeducation programme was offered to the intervention group. Measuring instruments were administered to the groups before the intervention, after the intervention, and 3 months after that. The measuring instruments consisted of a personal information form, the Facial Emotion Identification Test, Facial Emotion Discrimination Test, and Personal and Social Performance Scale. The data were analysed using the 'two-way repeated measures analysis of variance'. The TREND method was used for reporting. In the first measurements taken after the psychoeducation programme, a significant difference was found between the two groups in terms of their 'Facial Emotion Identification Test' and 'Personal and Social Performance Scale' mean scores. In the measurements taken 3 months after the psychoeducation programme, this difference had disappeared. The psychoeducation programme is an effective programme that makes recognition of facially expressed emotions possible and increases the social functioning of patients.",2020,"In the first measurements taken after the psychoeducation programme, a significant difference was found between the two groups in terms of their 'Facial Emotion Identification Test' and 'Personal and Social Performance Scale' mean scores.",['individuals diagnosed with schizophrenia'],['psychoeducation programme'],"['Facial Emotion Identification Test, Facial Emotion Discrimination Test, and Personal and Social Performance Scale', ""Facial Emotion Identification Test' and 'Personal and Social Performance Scale' mean scores""]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0255101,"In the first measurements taken after the psychoeducation programme, a significant difference was found between the two groups in terms of their 'Facial Emotion Identification Test' and 'Personal and Social Performance Scale' mean scores.","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Aşık', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Kırıkkale University, Kırıkkale, Turkey.'}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Ünsal', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Health Sciences, Marmara University, Istanbul, Turkey.'}]",International journal of mental health nursing,['10.1111/inm.12703']
3265,31265147,Development of a group structured education programme to support safe exercise in people with Type 1 diabetes: the EXTOD education programme.,"AIM


To develop a structured education programme for individuals with Type 1 diabetes who are engaging in regular exercise.
METHOD


A multidisciplinary team of experts in supporting exercise and physical activity for people with Type 1 diabetes, alongside researchers with experience of developing self-management education, developed an exercise programme using the Medical Research Council framework. The programme was informed by a review of the evidence relating to Type 1 diabetes and exercise, the behaviour change literature (including the behaviour change taxonomy), and qualitative interviews with stakeholders. The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
RESULTS


The outcome of the intervention development was the design of a feasible and acceptable intervention for people with Type 1 diabetes to support safe exercise. The pilot allowed refinement of the intervention prior to testing in a two-site feasibility randomized controlled trial. Key findings from the pilot informed minor restructuring of the timetable (timings and order) and adaptation of supporting educational materials (participant handbook and teaching materials).
CONCLUSION


The 'EXercise in people with Type One Diabetes' (EXTOD) education programme has been developed using robust methodology for the generation of educational interventions. It now needs testing in a randomized controlled trial.",2020,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
","['individuals with Type 1 diabetes who are engaging in regular exercise', ""people with Type One Diabetes' (EXTOD) education programme"", 'people with Type 1 diabetes']","['structured education programme', 'education programme to support safe exercise']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.0758452,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Narendran', 'Affiliation': 'Department of Diabetes, University Hospitals Birmingham NHS Foundation Trust, Birmingham.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Troughton', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals Leicester, Leicester.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Doherty', 'Affiliation': 'Department of Psychological Medicine, York Teaching Hospitals NHS Foundation Trust, York.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Quann', 'Affiliation': 'Leicester Clinical Trials Unit, College of Life Sciences, University of Leicester, Leicester.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Litchfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Andrews', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14064']
3266,32061002,"Low-Dose, Contrast-Enhanced Mammography Compared to Contrast-Enhanced Breast MRI: A Feasibility Study.","Contrast-enhanced MRI (CE-MRI) is the most sensitive technique for breast cancer detection. Contrast-enhanced mammography (CEM) is emerging as a possible alternative to CE-MRI.
PURPOSE


To evaluate the diagnostic performance of a low radiation dose contrast-enhanced mammography (L-CEM) in women with suspicious findings on conventional imaging compared to CE-MRI of the breast.
STUDY TYPE


Prospective, single center.
POPULATION


Women with suspicious findings on mammography, tomosynthesis, or ultrasound, and no contraindications for L-CEM or CE-MRI. Eighty women were included.
FIELD STRENGTH/SEQUENCE


1.5 and 3T CE-MRI, standard protocol for breast, with dedicated coils, according to international guidelines. L-CEM was performed using a dedicated prototype.
ASSESSMENT


Three, off-site, blinded readers evaluated the images according to the BI-RADS lexicon in a randomized order, each in two separate reading sessions. Histology served as a gold standard.
STATISTICAL TEST


Lesion detection rate, sensitivity, specificity, and negative and positive predictive values (NPV, PPV) were calculated and compared with multivariate statistics.
RESULTS


Included were 80 women (mean age, 54.3 years ±11.2 standard deviation) with 93 lesions (32 benign, 61 malignant). The detection rate was significantly higher with CE-MRI (92.5-94.6%; L-CEM 79.6-91.4%, P = 0.014). Sensitivity (L-CEM 65.6-90.2%; CE-MRI 83.6-93.4%, P = 0.086) and NPV (L-CEM 59.6-71.4%; CE-MRI 63.0-76.5%, P = 0.780) did not differ between the modalities. Specificity (L-CEM 46.9-96.9%; CE-MRI 37.5-53.1%, P = 0.001) and PPV (L-CEM 76.4-97.6%; CE-MRI 73.3-77.3%, P = 0.007) were significantly higher with L-CEM. Variations between readers were significant for sensitivity and NPV. The accuracy of L-CEM was as good as CE-MRI (75.3-76.3% vs. 72.0-75.3%, P = 0.514).
DATA CONCLUSION


L-CEM showed a high sensitivity and accuracy in women with suspicious findings on conventional imaging. Compared to CE-MRI, L-CEM has the potential to increase specificity and PPV. L-CEM might help to reduce false-positive biopsies while obtaining sensitivity comparable to that of CE-MRI LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY STAGE: 2 J. Magn. Reson. Imaging 2020;52:589-595.",2020,"The detection rate was significantly higher with CE-MRI (92.5-94.6%; L-CEM 79.6-91.4%, P = 0.014).","['Women with suspicious findings on mammography, tomosynthesis, or ultrasound, and no contraindications for L-CEM or CE-MRI', 'women with suspicious findings on conventional imaging compared to CE-MRI of the breast', '80 women (mean age, 54.3\u2009years ±11.2 standard deviation) with 93 lesions (32 benign, 61 malignant', 'Eighty women were included']","['L-CEM', 'low radiation dose contrast-enhanced mammography (L-CEM', 'Contrast-enhanced mammography (CEM', 'Low-Dose, Contrast-Enhanced Mammography', 'Contrast-enhanced MRI (CE-MRI']","['accuracy of L-CEM', 'sensitivity and accuracy', 'detection rate', 'PPV', 'diagnostic performance', 'sensitivity and NPV', 'Specificity', 'Sensitivity', 'Lesion detection rate, sensitivity, specificity, and negative and positive predictive values (NPV, PPV']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0378574', 'cui_str': 'CEMS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0378574', 'cui_str': 'CEMS'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0378574', 'cui_str': 'CEMS'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.0348892,"The detection rate was significantly higher with CE-MRI (92.5-94.6%; L-CEM 79.6-91.4%, P = 0.014).","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Clauser', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Pascal A T', 'Initials': 'PAT', 'LastName': 'Baltzer', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Kapetas', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hoernig', 'Affiliation': 'Diagnostic Imaging, Siemens Healthcare GmbH, Forchheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Division of General and Pediatric Radiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'ASST Fatebenefratelli-Sacco, Ospedale Fatebenefrateli e Oftalmico, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bernathova', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Helbich', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27079']
3267,32063531,Periodontal health in shortened dental arches: A 10-year RCT.,"PURPOSE


This analysis focused on periodontal health in shortened dental arches (SDAs).
METHODS


In a randomized controlled clinical trial, patients with missing molars in one jaw and at least one premolar and canine on both sides were eligible for participation. In the partial removable dental prosthesis (PRDP) group (n = 79), molars were replaced with a precision attachment retained PRDP. In the SDA group (n == 71), the SDA up to the second premolars was either left as is or restored with fixed dental prostheses. Outcome variables were vertical clinical attachment loss (CAL-V), pocket probing depth (PPD), bleeding on probing (BOP) and plaque index (PLI). For CAL-V and PPD, the changes at six measuring points per tooth were analyzed. For BOP and PLI, patient related rates were calculated for each point in time. Statistical methods included linear regression analyses.
RESULTS


In the intention-to-treat (ITT) analysis for CAL-V in the study jaw, the 10 year patient related mean changes were 0.66 mm in the PRDP group and -0.13 mm in the SDA group. The resulting mean patient related group difference of 0.79 mm (95% CI: 0.20 mm-1.38 mm) was significant (p = 0.01). There were no significant differences in the ITT analyses for PPD. For BOP and PLI, significant group differences with more favorable results for the SDA group were found.
CONCLUSIONS


In view of lacking substantial differences for CAL-V and PPD, the overall differences were considered of minor clinical relevance. The results add confirmatory evidence to the shortened dental arch concept and its clinical viability (controlled-trials.com ISRCTN97265367).",2020,The resulting mean patient related group difference of 0.79 mm (95% CI: 0.20 mm-1.38 mm) was significant (p = 0.01).,"['patients with missing molars in one jaw and at least one premolar and canine on both sides were eligible for participation', 'shortened dental arches']","['SDA', 'partial removable dental prosthesis (PRDP']","['vertical clinical attachment loss (CAL-V), pocket probing depth (PPD), bleeding on probing (BOP) and plaque index (PLI', 'Periodontal health', 'ITT analyses for PPD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0011325', 'cui_str': 'Dental Arch'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0162686', 'cui_str': 'Dental Prosthesis'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]",,0.100739,The resulting mean patient related group difference of 0.79 mm (95% CI: 0.20 mm-1.38 mm) was significant (p = 0.01).,"[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Walter', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, Dresden 01307, Germany. Electronic address: michael.walter@uniklinikum-dresden.de.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreyhaupt', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Schwabstraße 13, Ulm 89075, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Mundt', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Biomaterials, Dental School, University of Greifswald, Rotgerberstr. 8, Greifswald 17487, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kohal', 'Affiliation': 'Department of Prosthetic Dentistry, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, Freiburg im Breisgau 79106, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Department of Prosthodontics, Propaedeutics and Dental Materials, School of Dentistry, Christian-Albrechts University, Christian-Albrechts-Platz 4, Kiel 24118, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Rauch', 'Affiliation': 'Department of Prosthodontics and Materials Science, University of Leipzig, Liebigstr. 18, Leipzig 04103, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Nothdurft', 'Affiliation': 'Department of Prosthetic Dentistry and Dental Materials Science, Medical Center, Dental School and Clinics, Saarland University, Campus Homburg, Kirrberger Str. 100, Homburg/Saar 66421, Germany.'}, {'ForeName': 'Sinsa', 'Initials': 'S', 'LastName': 'Hartmann', 'Affiliation': 'Department of Prosthetic Dentistry, Johannes-Gutenberg University of Mainz, Langenbeckstr. 1, Mainz 55131, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Böning', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, Dresden 01307, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Prosthetic Dentistry, Julius-Maximilians University of Würzburg, Pleicherwall 2, Würzburg 97070, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Stark', 'Affiliation': 'Department of Prosthodontics, Preclinical Education and dental Materials Science, University of Bonn, Welschnonnenstr.17, Bonn 53111, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Edelhoff', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Ludwig-Maximilians-University, Goethestraße 70, Munich 80336, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wöstmann', 'Affiliation': 'Department of Prosthetic Dentistry, Justus-Liebig University of Gießen, Rudolf-Buchheim-Str. 8, Gießen 35392, Germany.'}, {'ForeName': 'Ralph Gunnar', 'Initials': 'RG', 'LastName': 'Luthardt', 'Affiliation': 'Department of Prosthetic Dentistry, Center of Dentistry, Universitätsklinikum Ulm, Albert-Einstein-Allee 11, Ulm 89081, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hannak', 'Affiliation': 'Charité - Universitätsmedizin Berlin, CC3 - Charité, Center for Dental and Craniofacial Sciences, Department of Prosthodontics, Geriatic Dentistry and Craniomandibular Disorders, Campus Benjamin Franklin, Aßmannshauser Straße 4-6, Berlin 14197, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wolfart', 'Affiliation': 'Department of Prosthodontics and Biomaterials, Medical Faculty, RWTH Aachen University, Pauwelsstr. 30, Aachen 52074, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Heydecke', 'Affiliation': 'Department of Prosthodontics, University Medical Center Eppendorf, Zahnärztliche Prothetik, Martinistr. 52, Hamburg 20246, Germany.'}, {'ForeName': 'Florentine', 'Initials': 'F', 'LastName': 'Jahn', 'Affiliation': 'Department of Prosthetic Dentistry and Dental Material Science, Friedrich-Schiller University of Jena, Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde, An der Alten Post 4, Jena 07743, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pospiech', 'Affiliation': 'Vogelweidestr. 5, 97230 Estenfeld, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Marré', 'Affiliation': 'Department of Prosthetic Dentistry, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, Dresden 01307, Germany.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2020.01.005']
3268,32067259,Baseline and interim PET-based outcome prediction in peripheral T-cell lymphoma: A subgroup analysis of the PETAL trial.,"The prospective randomized Positron Emission Tomography (PET)-Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL) trial was designed to test the ability of interim PET (iPET) to direct therapy. As reported previously, outcome remained unaffected by iPET-based treatment changes. In this subgroup analysis, we studied the prognostic value of baseline total metabolic tumor volume (TMTV) and iPET response in 76 patients with T-cell lymphoma. TMTV was measured using the 41% maximum standardized uptake value (SUV 41max  ) and SUV 4  thresholding methods. Interim PET was performed after two treatment cycles and evaluated using the ΔSUV max  approach and the Deauville scale. Because of significant differences in outcome, patients with anaplastic lymphoma kinase (ALK)-positive lymphoma were analyzed separately from patients with ALK-negative lymphoma. In the latter, TMTV was statistically significantly correlated with progression-free survival, with thresholds best dichotomizing the population, of 232 cm 3  using SUV 41max  and 460 cm 3  using SUV 4  . For iPET response, the respective thresholds were 46.9% SUV max  reduction and Deauville score 1-4 vs 5. The proportion of poor prognosis patients was 46% and 29% for TMTV by SUV 41max  and SUV 4  , and 29% and 25% for iPET response by ΔSUV max  and Deauville, respectively. At diagnosis, the hazard ratio (95% confidence interval) for poor prognosis vs good prognosis patients according to TMTV was 2.291 (1.135-4.624) for SUV 41max  and 3.206 (1.524-6.743) for SUV 4  . At iPET, it was 3.910 (1.891-8.087) for ΔSUV max  and 4.371 (2.079-9.187) for Deauville. On multivariable analysis, only TMTV and iPET response independently predicted survival. Patients with high baseline TMTV and poor iPET response (22% of the population) invariably progressed or died within the first year (hazard ratio, 9.031 [3.651-22.336]). Due to small numbers and events, PET did not predict survival in ALK-positive lymphoma. Baseline TMTV and iPET response are promising tools to select patients with ALK-negative T-cell lymphoma for early allogeneic transplantation or innovative therapies.",2020,"For iPET response, the respective thresholds were 46.9% SUV max  reduction and Deauville score 1-4 vs 5.","['76 patients with T-cell lymphoma', 'peripheral T-cell lymphoma', 'patients with ALK-negative T-cell lymphoma for early allogeneic transplantation or innovative therapies', 'patients with anaplastic lymphoma kinase (ALK)-positive lymphoma were analyzed separately from patients with ALK-negative lymphoma']",['Positron Emission Tomography (PET)-Guided Therapy'],"['prognostic value of baseline total metabolic tumor volume (TMTV) and iPET response', 'iPET response', 'progression-free survival', 'TMTV', 'hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079772', 'cui_str': 'T-Cell Lymphoma'}, {'cui': 'C0079774', 'cui_str': 'Peripheral T-Cell Lymphoma'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic Grafting'}, {'cui': 'C1136080', 'cui_str': 'Innovative Therapies'}, {'cui': 'C0252409', 'cui_str': 'NPM-ALK'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",76.0,0.0585731,"For iPET response, the respective thresholds were 46.9% SUV max  reduction and Deauville score 1-4 vs 5.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rekowski', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universität Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Müller', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Medizinische Klinik I, Klinikum Bremen-Mitte, Bremen, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Franzius', 'Affiliation': 'Zentrum für moderne Diagnostik (Zemodi), Zentrum für Nuklearmedizin und PET/CT, Bremen, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Bengel', 'Affiliation': 'Klinik für Nuklearmedizin, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kroschinsky', 'Affiliation': 'Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kotzerke', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'La Rosée', 'Affiliation': 'Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Freesmeyer', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Heinz-Gert', 'Initials': 'HG', 'LastName': 'Hoeffkes', 'Affiliation': 'Tumorklinik, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hertel', 'Affiliation': 'Klinik für Diagnostische und Therapeutische Nuklearmedizin, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Behringer', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Palliativmedizin, Augusta-Kranken-Anstalt, Bochum, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Mesters', 'Affiliation': 'Medizinische Klinik A, Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weckesser', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Mahlmann', 'Affiliation': 'Klinik für Innere Medizin 1, Westpfalz-Klinikum,, Kaiserslautern, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Haberkorn', 'Affiliation': 'Radiologische Klinik und Poliklinik, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Martens', 'Affiliation': 'Klinik für Innere Medizin III: Hämatologie, Onkologie, Palliativmedizin, Klinikum am Gesundbrunnen, Heilbronn, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Prange-Krex', 'Affiliation': 'Onkologische Gemeinschaftspraxis, Dresden, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Brenner', 'Affiliation': 'Klinik für Nuklearmedizin, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Klinik für Onkologie, Hämatologie und Palliativmedizin, Marien Hospital, Düsseldorf, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Moeller', 'Affiliation': 'Hämatologisch-onkologische Gemeinschaftspraxis, Halle, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Runde', 'Affiliation': 'Klinik für Innere Medizin mit den Schwerpunkten Hämatologie, Onkologie und Palliativmedizin, Wilhelm-Anton-Hospital, Goch, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Sandmann', 'Affiliation': 'Klinik für Innere Medizin III - Hämatologie und Onkologie, Palliativmedizin, Petrus-Krankenhaus, Wuppertal, Germany.'}, {'ForeName': 'Hubertus', 'Initials': 'H', 'LastName': 'Hautzel', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wilop', 'Affiliation': 'Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Universitätsklinikum Aachen, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krohn', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Aachen, Aachen, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Dürk', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Palliativmedizin, Evangelisches Krankenhaus, Hamm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heike', 'Affiliation': 'Klinik für Gastroenterologie, Hämatologie und internistische Onkologie und Endokrinologie, Klinikum Dortmund, Germany.'}, {'ForeName': 'Ferras', 'Initials': 'F', 'LastName': 'Alashkar', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Brinkmann', 'Affiliation': 'Zentrum für Klinische Studien Essen (ZKSE), Universität Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Trenn', 'Affiliation': 'Klinik für Innere Medizin I, Knappschaftskrankenhaus, Bottrop, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Wacker', 'Affiliation': 'Medizinische Klinik III, Hämatologie, Onkologie und Palliativmedizin, Klinikum Vest, Recklinghausen, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Kreisel-Büstgens', 'Affiliation': 'Zentrum für Hämatologie und Onkologie, Porta Westfalica, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Medizinische Klinik V, Klinikum Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Heil', 'Affiliation': 'Klinik für Hämatologie und Onkologie, Klinikum Lüdenscheid, Lüdenscheid, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Larisch', 'Affiliation': 'Klinik für Nuklearmedizin, Klinikum Lüdenscheid, Lüdenscheid, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kurch', 'Affiliation': 'Klinik und Poliklinik für Nuklearmedizin, Universitätsklinikum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Jöckel', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universität Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Hoelzer', 'Affiliation': 'Onkologikum, Frankfurt/Main, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Institut für Pathologie, Sektion für Hämatopathologie, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Boellaard', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, Location VUMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}]",Hematological oncology,['10.1002/hon.2697']
3269,31943807,Selection for psychosocial treatment for youth at clinical high risk for psychosis based on the North American Prodrome Longitudinal Study individualized risk calculator.,"AIM


Recent findings suggest that family-focused therapy (FFT) is effective for individuals at clinical high-risk for psychosis (CHR-P). As outcomes of CHR-P individuals are quite varied, certain psychosocial interventions may be differentially effective in subgroups. The present study examined change in positive symptoms for CHR-P individuals at different levels of predicted risk for conversion to psychosis who received either FFT, a brief form of family education termed enhanced care (EC) or treatment as usual.
METHODS


Participants were drawn from the North American Prodromal Longitudinal Study (NAPLS2). A subset of NAPLS2 participants completed a randomized study involving FFT or EC. The present study includes participants from the FFT-CHR sub-study and non-randomized NAPLS2 participants. Predicted risk of conversion was calculated using the Individualized Risk Calculator for Psychosis. Robust linear regressions evaluated whether the association between predicted risk of conversion and positive symptom change differed across intervention groups.
RESULTS


A total of 94 participants from the FFT-CHR sub-study (FFT-CHR n = 50, EC n = 44) and 401 non-randomized NAPLS2 participants were included in this study. There was a treatment group by predicted risk of conversion interaction that predicted positive symptom improvement: higher risk individuals improved more with FFT-CHR than EC or the non-randomized NAPLS group, whereas lower-risk individuals did not differ in positive symptom improvement across treatment groups (FFT-CHR vs EC: P = .03, β = 20.27; FFT-CHR vs NAPLS2: P < .001, β = 28.40).
CONCLUSIONS


Intensive treatments such as FFT-CHR may be most appropriate for individuals at the highest levels of clinical risk for psychosis.",2020,"There was a treatment group by predicted risk of conversion interaction that predicted positive symptom improvement: higher risk individuals improved more with FFT-CHR than EC or the non-randomized NAPLS group, whereas lower-risk individuals did not differ in positive symptom improvement across treatment groups (FFT-CHR vs EC: P = .03, β = 20.27; FFT-CHR vs NAPLS2: P < .001, β = 28.40).
","['participants from the FFT-CHR sub-study and non-randomized NAPLS2 participants', 'Participants were drawn from the North American Prodromal Longitudinal Study (NAPLS2', '94 participants from the FFT-CHR sub-study (FFT-CHR n = 50, EC n = 44) and 401 non-randomized NAPLS2 participants were included in this study']","['family-focused therapy (FFT', 'FFT or EC', 'FFT']","['positive symptom improvement', 'risk of conversion and positive symptom change']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",94.0,0.0665011,"There was a treatment group by predicted risk of conversion interaction that predicted positive symptom improvement: higher risk individuals improved more with FFT-CHR than EC or the non-randomized NAPLS group, whereas lower-risk individuals did not differ in positive symptom improvement across treatment groups (FFT-CHR vs EC: P = .03, β = 20.27; FFT-CHR vs NAPLS2: P < .001, β = 28.40).
","[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Worthington', 'Affiliation': 'Department of Psychology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry, UCLA Semel Institute, University of California, Los Angeles, California.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Addington', 'Affiliation': 'Department of Psychiatry, Hotchkiss Brain Institute, Calgary, Alberta, Canada.'}, {'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'Bearden', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences and Psychology, UCLA, Los Angeles, California.'}, {'ForeName': 'Kristin S', 'Initials': 'KS', 'LastName': 'Cadenhead', 'Affiliation': 'Department of Psychiatry, UCSD, San Diego, California.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Cornblatt', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Long Island, New York.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'Department of Psychiatry, UCSF, and SFVA Medical Center, San Francisco, California.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'McGlashan', 'Affiliation': 'Department of Psychiatry, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Diana O', 'Initials': 'DO', 'LastName': 'Perkins', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Seidman', 'Affiliation': 'Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Ming T', 'Initials': 'MT', 'LastName': 'Tsuang', 'Affiliation': 'Department of Psychiatry, UCSD, San Diego, California.'}, {'ForeName': 'Elaine F', 'Initials': 'EF', 'LastName': 'Walker', 'Affiliation': 'Department of Psychology and Psychiatry, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Tyrone D', 'Initials': 'TD', 'LastName': 'Cannon', 'Affiliation': 'Department of Psychology, Yale University, New Haven, Connecticut.'}]",Early intervention in psychiatry,['10.1111/eip.12914']
3270,30994376,"Adiposity, Hepatic Triglyceride, and Carotid Intima Media Thickness During Behavioral Weight Loss Treatment in Antipsychotic-Treated Youth: A Randomized Pilot Study.","Objectives:  The purpose of this pilot study was to evaluate changes in adiposity, carotid intima media thickness (CIMT), and hepatic fat content measured via magnetic resonance imaging-estimated hepatic proton density fat fraction (PDFF) in antipsychotic (AP)-treated youth versus nonpsychiatric (NP) participants during participation in a 16-week behavioral weight loss (BWL) intervention.  Subjects/Methods:  Overweight/obese AP-treated youth ( n  = 26) were randomized 2:1 to weekly treatment versus recommended care (RC) over 16 weeks. NP controls ( n  = 21) were assigned to weekly treatment. Dual-energy X-ray absorptiometry (DEXA)-measured adiposity, CIMT, and PDFF were measured at baseline and 16 weeks. Analyses assessed group differences in the effect of BWL on adiposity, CIMT, and PDFF.  Results:  BWL was well tolerated in both AP-treated and NP groups. DEXA-measured fat decreased significantly in the NP group ( F [1,16] = 11.81,  p  = 0.003), with modest improvements in adiposity and hepatic fat in the AP-treated group, while an increase in adiposity was observed in the RC group. Significant differences in endpoint DEXA total fat ( F [2,34] = 4.81,  p  = 0.01) and PDFF ( F [2,30] = 3.60,  p  = 0.04) occurred across treatment groups, explained by larger improvements in NP versus RC youth in DEXA total fat ( p  = 0.03) and PDFF ( p  = 0.04).  Conclusions:  Intensive, family-based BWL treatment can improve whole-body adiposity and liver fat in obese youth, with decreases or attenuation of additional fat gain observed in AP-treated youth.",2019,"Significant differences in endpoint DEXA total fat ( F [2,34] = 4.81,  p  = 0.01) and PDFF ( F [2,30] = 3.60,  p  = 0.04) occurred across treatment groups, explained by larger improvements in NP versus RC youth in DEXA total fat ( p  = 0.03) and PDFF ( p  = 0.04).  ","['Antipsychotic-Treated Youth', 'Overweight/obese AP-treated youth ( n \u2009=\u200926']",['antipsychotic (AP)-treated youth versus nonpsychiatric (NP) participants during participation in a 16-week behavioral weight loss (BWL) intervention'],"['DEXA-measured fat', 'tolerated', 'PDFF', 'Dual-energy X-ray absorptiometry (DEXA)-measured adiposity, CIMT, and PDFF', 'adiposity', 'effect of BWL on adiposity, CIMT, and PDFF', 'adiposity, carotid intima media thickness (CIMT), and hepatic fat content', 'endpoint DEXA total fat', 'adiposity and hepatic fat', 'Adiposity, Hepatic Triglyceride, and Carotid Intima Media Thickness']","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",26.0,0.0372611,"Significant differences in endpoint DEXA total fat ( F [2,34] = 4.81,  p  = 0.01) and PDFF ( F [2,30] = 3.60,  p  = 0.04) occurred across treatment groups, explained by larger improvements in NP versus RC youth in DEXA total fat ( p  = 0.03) and PDFF ( p  = 0.04).  ","[{'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kolko', 'Affiliation': '2Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Department of Psychiatry, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Yingling', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Ricchio', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Schweiger', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': '4Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Wilfley', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0120']
3271,31246661,Fractional CO2 laser versus promestriene and lubricant in genitourinary syndrome of menopause: a randomized clinical trial.,"OBJECTIVE


The aim of this study was to compare the effects of fractional CO2 laser therapy, promestriene, and vaginal lubricants on genitourinary syndrome treatment and sexual function in postmenopausal women.
METHODS


We performed a randomized clinical trial including 72 postmenopausal women over the age of 50 years. The women were randomized into three intervention groups to receive one of the following treatments: three sessions of intravaginal fractional CO2 laser therapy; 10 mg of intravaginal promestriene cream 3 times a week; and vaginal lubricant application alone. Vaginal maturation, Vaginal Health Index (VHI) score, and Female Sexual Function Index (FSFI) were evaluated at baseline and after 14 weeks of therapy.
RESULTS


We observed an improvement in the vaginal elasticity, volume, moisture, and pH in the CO2 laser and promestriene groups. The VHI score at 14 weeks was higher in the CO2 laser group (mean score 18.68) than in the promestriene (15.11) and lubricant (10.44) groups (P < 0.001). Regarding vaginal maturation, basal cells were reduced and superficial cells were increased after treatment. This improvement was more significant in the CO2 laser group (P <0.001). The FSFI score only showed improvement in the desire and lubrication domains in the CO2 laser group. There were no differences in total FSFI score among the three treatment groups. There were no adverse effects associated with any of the treatments.
CONCLUSIONS


The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.",2019,The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.,"['postmenopausal women', 'genitourinary syndrome of menopause', '72 postmenopausal women over the age of 50 years']","['fractional CO2 laser therapy', 'CO2 laser', 'promestriene or lubricant', 'Fractional CO2 laser versus promestriene and lubricant', 'fractional CO2 laser therapy, promestriene, and vaginal lubricants', 'intravaginal fractional CO2 laser therapy; 10\u200amg of intravaginal promestriene cream 3 times a week; and vaginal lubricant application alone']","['vaginal health', 'desire and lubrication domains', 'Vaginal maturation, Vaginal Health Index (VHI) score, and Female Sexual Function Index (FSFI', 'total FSFI score', 'vaginal maturation, basal cells', 'VHI score', 'FSFI score', 'vaginal elasticity, volume, moisture, and pH', 'superficial cells']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0072151', 'cui_str': 'promestriene'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0356770', 'cui_str': 'Vaginal lubricant'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1318469', 'cui_str': 'Lubrication'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0013764'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",72.0,0.0695038,The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.,"[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Politano', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, State University of Campinas-UNICAMP Campinas, São Paulo, Brazil.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Costa-Paiva', 'Affiliation': ''}, {'ForeName': 'Luiza B', 'Initials': 'LB', 'LastName': 'Aguiar', 'Affiliation': ''}, {'ForeName': 'Helymar C', 'Initials': 'HC', 'LastName': 'Machado', 'Affiliation': ''}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Baccaro', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001333']
3272,32056815,Effects of yoga on anxiety and depression for high risk mothers on hospital bedrest.,"BACKGROUND


and purpose: In recent years, yoga practitioners have joined forces with medical programs to approach patients' well-being holistically. This study is a randomized controlled trial to assess the effects of a specialized adapted yoga program on anxiety and depression for high-risk expectant mothers on bedrest in a hospital setting.
MATERIALS AND METHODS


Seventy-nine pregnant subjects on physician ordered hospitalized bedrest were randomized into two groups: receiving biweekly yoga sessions (intervention group) or receiving no yoga (control group). Data collection tool was the Hospital Anxiety and Depression Scale (HADS) to assess outcomes after delivery.
RESULTS


Yoga, even as little as three sessions, showed significant impact in reducing anxiety and depression high-risk pregnant women on hospitalized bedrest. Perceived anxiety and depression overall scores were lower in the intervention group than in the control group (p < 0.001).
CONCLUSION


Results demonstrated that yoga is an effective intervention to decrease anxiety and depression in high-risk antepartum women on hospitalized bedrest.",2020,"Perceived anxiety and depression overall scores were lower in the intervention group than in the control group (p < 0.001).
","['high-risk antepartum women on hospitalized bedrest', 'high-risk expectant mothers on bedrest in a hospital setting', 'high risk mothers on hospital bedrest', 'Seventy-nine pregnant subjects on physician ordered hospitalized bedrest']","['specialized adapted yoga program', 'biweekly yoga sessions (intervention group) or receiving no yoga (control group', 'yoga']","['Hospital Anxiety and Depression Scale (HADS', 'anxiety and depression', 'Perceived anxiety and depression overall scores']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0456336', 'cui_str': 'Antepartum (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",79.0,0.0371992,"Perceived anxiety and depression overall scores were lower in the intervention group than in the control group (p < 0.001).
","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gallagher', 'Affiliation': 'Forsyth Medical Center, United States. Electronic address: northjoyyoga@yahoo.com.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Kring', 'Affiliation': 'Forsyth Medical Center, United States.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Whitley', 'Affiliation': 'Forsyth Medical Center, United States.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101079']
3273,32056816,"Stretching exercises combined with ischemic compression in pectoralis minor muscle with latent trigger points: A single-blind, randomized, controlled pilot trial.","BACKGROUND AND PURPOSE


Latent trigger points (LTrPs) in the pectoralis minor (PM) muscle lead to muscle tightness. This study aimed to investigate which type of stretching exercise used after ischemic compression (IC) was more effective on LTrPs in the PM muscle.
MATERIALS AND METHODS


Forty participants with PM muscle tightness and an LTrP in the PM muscle were divided among groups 1 (IC with modified contract-relax proprioceptive neuromuscular facilitation (PNF) stretching), 2 (IC with static stretching), 3 (IC with myofascial release) and 4 (no intervention). The PM muscle index (PMI), PM length (PML), rounded shoulder posture, pressure pain threshold, pulmonary function, and maximal respiratory pressure were evaluated.
RESULTS


Improvement in the PMI and PML was found immediately after the intervention in groups 1 and 3 compared with baseline (p = 0.01). The overall group-by-time interaction in the repeated measures analysis of variance was significant for the PMI in favor of Group 1 (F 1, 36  = 3.53, p = 0.02).
CONCLUSION


IC may be followed by contract-relax PNF stretching to increase the length of PM muscle with LTrPs.",2020,"RESULTS


Improvement in the PMI and PML was found immediately after the intervention in groups 1 and 3 compared with baseline (p = 0.01).","['Forty participants with PM muscle tightness and an LTrP in the PM muscle', 'pectoralis minor muscle with latent trigger points']","['stretching exercise used after ischemic compression (IC', '1 (IC with modified contract-relax proprioceptive neuromuscular facilitation (PNF) stretching), 2 (IC with static stretching), 3 (IC with myofascial release) and 4 (no intervention', 'Stretching exercises combined with ischemic compression']","['PMI and PML', 'PM muscle index (PMI), PM length (PML), rounded shoulder posture, pressure pain threshold, pulmonary function, and maximal respiratory pressure', 'length of PM muscle']","[{'cui': 'C0877322', 'cui_str': 'Muscle tightness'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C1720874', 'cui_str': 'Proprioceptive Neuromuscular Facilitation (PNF) Stretching'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4277579', 'cui_str': 'Maximum Respiratory Pressures'}]",40.0,0.0681553,"RESULTS


Improvement in the PMI and PML was found immediately after the intervention in groups 1 and 3 compared with baseline (p = 0.01).","[{'ForeName': 'Tansu', 'Initials': 'T', 'LastName': 'Birinci', 'Affiliation': 'Istanbul University-Cerrahpasa, Institute of Graduate Studies, Division of Physiotherapy and Rehabilitation, Istanbul, Turkey; Istanbul Medeniyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey.'}, {'ForeName': 'Rustem', 'Initials': 'R', 'LastName': 'Mustafaoglu', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Kaya Mutlu', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: fztebrukaya@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Razak Ozdincler', 'Affiliation': 'Biruni University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101080']
3274,32056817,"Effect of pranayama breathing technique on asthma control, pulmonary function, and quality of life: A single-blind, randomized, controlled trial.","OBJECTIVE


This study evaluated the effect of pranayama on asthma control, pulmonary function, and quality of life in people with asthma.
METHODS


Pranayama was applied to the pranayama group for 20 min once daily for 1 month, and relaxation was applied to the relaxation group similarly in addition to the standard treatment. The outcome measurement tools used were the Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function test (PFT), and patient observation chart.
RESULTS


The pranayama group had significantly higher ACT score, overall AQLQ score, and subscale scores than the relaxation group (p < 0.05). However, there was no significant difference between the groups in terms of PFT parameters and peak expiratory flow values (p > 0.05).
CONCLUSION


Pranayama improved asthma control and asthma-related quality of life in people with asthma, but it did not show a significant difference in PFT values.",2020,"The pranayama group had significantly higher ACT score, overall AQLQ score, and subscale scores than the relaxation group (p < 0.05).",['people with asthma'],"['pranayama', 'pranayama breathing technique']","['asthma control and asthma-related quality of life', 'ACT score, overall AQLQ score, and subscale scores', 'PFT parameters and peak expiratory flow values', 'asthma control, pulmonary function, and quality of life', 'PFT values', 'Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function test (PFT), and patient observation chart']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0684240', 'cui_str': 'Chart'}]",,0.0302259,"The pranayama group had significantly higher ACT score, overall AQLQ score, and subscale scores than the relaxation group (p < 0.05).","[{'ForeName': 'Gülyeter', 'Initials': 'G', 'LastName': 'Erdoğan Yüce', 'Affiliation': 'Department of Aged Care, Nevsehir Haci Bektas Veli University, Nevsehir, Turkey. Electronic address: gulyeterdogan@nevsehir.edu.tr.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Taşcı', 'Affiliation': 'Department of Internal Nursing, Erciyes University, Kayseri, Turkey. Electronic address: sultant@erciyes.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101081']
3275,32056820,"The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial.","BACKGROUND


and purpose: This study aimed to determine the effect of music therapy on pain, anxiety, and patient comfort during colonoscopy.
MATERIALS AND METHODS


This is a randomized, controlled, intervention study, which included 112 patients that underwent colonoscopy. The patients were randomized into the intervention group (n = 56) that was given 30-minute music therapy during the colonoscopy and the control group (n = 56) without any intervention other than routine nursing care. The data were collected using an information and observation form, the Visual Analog Scale (VAS) and the Spielberger State-Trait Anxiety Inventory.
RESULTS


The pain and anxiety scores were lower in the intervention group whereas comfort score was higher than control group (p < 0.05). The pain and anxiety levels of the patients in the intervention group decreased after the colonoscopy and their comfort levels increased.
CONCLUSIONS


The music therapy reduced pain and anxiety, increased comfort during colonoscopy.",2020,The pain and anxiety scores were lower in the intervention group whereas comfort score was higher than control group (p < 0.05).,['112 patients that underwent colonoscopy'],"['music therapy during the colonoscopy and the control group (n\xa0=\xa056) without any intervention other than routine nursing care', 'music therapy']","['comfort score', 'pain and anxiety levels', 'pain and anxiety scores', 'pain and anxiety, increased comfort during colonoscopy', 'pain, anxiety, and patient comfort', 'pain, anxiety and patient comfort', 'Visual Analog Scale (VAS) and the Spielberger State-Trait Anxiety Inventory']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}]",112.0,0.0908127,The pain and anxiety scores were lower in the intervention group whereas comfort score was higher than control group (p < 0.05).,"[{'ForeName': 'Dilruba', 'Initials': 'D', 'LastName': 'Çelebi', 'Affiliation': 'Manisa Celal Bayar University, Institute of Health Science, Department of Surgical Nursing, Manisa, Turkey. Electronic address: melis_028@hotmail.com.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Health Science, Department of Surgical Nursing, Manisa, Turkey. Electronic address: emelyilmazcbu@gmail.com.'}, {'ForeName': 'Semra Tutcu', 'Initials': 'ST', 'LastName': 'Şahin', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Medical School, Department of General Surgery, Manisa, Turkey. Electronic address: semratutcu@gmail.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Baydur', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Health Science, Department of Social Work, Manisa, Turkey. Electronic address: hakan.baydur@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101084']
3276,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3277,31757473,"Effect of Aspiration and Evaluation of Gastric Residuals on Intestinal Inflammation, Bleeding, and Gastrointestinal Peptide Level.","OBJECTIVE


To determine the effect of gastric residual aspiration and evaluation on preterm very low birth weight infants' gastrointestinal function, intestinal inflammation, and gastrointestinal mucosal bleeding.
STUDY DESIGN


This single-center, randomized trial compared omission of gastric residuals vs prefeed gastric residuals in 143 infants ≤32 weeks of gestation with a birthweight of ≤1250 g for 6 weeks after birth. Serum levels of gastrin and motilin were collected between 14 and 21 days of life. Stools were collected at 3 and 6 weeks of age and analyzed for calprotectin and S100A12 levels. All stools were tested for occult blood for 6 weeks.
RESULTS


Means for gastrin (P = .999) and motilin (P = .694) were similar between groups and there were no statistically significant differences in adjusted means for transformed calprotectin (P = .580), and S100A12 (P = .212). Both calprotectin (P = .003) and S100A12 (P = .002) increased from week 3 to week 6. The mean percentage of stools positive for occult blood (P = .888) were similar between the groups.
CONCLUSIONS


Gastrointestinal function, intestinal inflammation, and gastrointestinal mucosal bleeding were similar whether aspiration and evaluation of gastric residuals were eliminated or not, suggesting routinely evaluating gastric residuals before every feeding may be unnecessary. TRIAL REGISTRATION CLINICALTRIALS.GOV:: NCT01863043.",2020,"The mean percentage of stools positive for occult blood (P = .888) were similar between the groups.
","['preterm very low birth weight infants', '143 infants ≤32']",['gastric residual aspiration and evaluation'],"['Intestinal Inflammation, Bleeding, and Gastrointestinal Peptide Level', 'transformed calprotectin', 'Gastrointestinal function, intestinal inflammation, and gastrointestinal mucosal bleeding', 'gastrointestinal function, intestinal inflammation, and gastrointestinal mucosal bleeding', 'mean percentage of stools positive for occult blood', 'Serum levels of gastrin and motilin']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C3665864', 'cui_str': 'Gastric residuals'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2748540', 'cui_str': 'Mucosal bleeding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0028792', 'cui_str': 'Occult Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0376180', 'cui_str': 'Gastrin'}, {'cui': 'C0026594', 'cui_str': 'Motilin (substance)'}]",143.0,0.129509,"The mean percentage of stools positive for occult blood (P = .888) were similar between the groups.
","[{'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Parker', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL. Electronic address: Parkela@ufl.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weaver', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL.'}, {'ForeName': 'Roberto J', 'Initials': 'RJ', 'LastName': 'Murgas Torrazza', 'Affiliation': 'Sistema Nacional de Investigacion de Panama, Secretaria Nacional de Ciencia Tecnologia e Innovacion, Panama City, Panama.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': 'Department of Health Outcomes and Bioinformatics, University of Florida, Gainesville, FL.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville, FL.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Krueger', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Neu', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville, FL.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.10.036']
3278,30075959,Mini-Stern Trial: A randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement.,"OBJECTIVE


Aortic valve replacement (AVR) can be performed either through full median sternotomy (FS) or upper mini-sternotomy (MS). The Mini-Stern trial aimed to establish whether MS leads to quicker postoperative recovery and shorter hospital stay after first-time isolated AVR.
METHODS


This pragmatic, open-label, parallel randomized controlled trial (RCT) compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analyzed in the intent-to-treat population.
RESULTS


In this RCT, 222 patients were recruited and randomized (n = 118 in the MS group; n = 104 in the FS group). Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days). Adjusting for valve type, sex, and surgeon, hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR, 0.874; 95% confidence interval [CI], 0.668-1.143; P = .3246) or time to fitness for discharge (HR, 0.907; 95% CI, 0.688-1.197; P value = .4914). During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group), 12 patients (10%) in the MS group and 7 patients (7%) in the FS group died (HR, 1.871; 95% CI, 0.723-4.844; P = .1966). Average extra cost for MS was £1714 during the first 12 months after AVR.
CONCLUSIONS


Compared with FS for AVR, MS did not result in shorter hospital stay, faster recovery, or improved survival and was not cost-effective. The MS approach is not superior to FS for performing AVR.",2018,"Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days).","['2 United Kingdom National Health Service hospitals', '118 in the MS group; n\xa0', '222 patients were recruited and randomized (n\xa0']","['Aortic valve replacement (AVR', 'mini-sternotomy to full median sternotomy for aortic valve replacement', 'full median sternotomy (FS) or upper mini-sternotomy (MS']","['time to fitness for discharge', 'hospital stay', 'shorter hospital stay, faster recovery, or improved survival', 'Average extra cost for MS', 'longer hospital length of stay', 'duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analyzed in the intent-to-treat population']","[{'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C1282959', 'cui_str': 'Median Sternotomy'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",222.0,0.0645762,"Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days).","[{'ForeName': 'Sukumaran K', 'Initials': 'SK', 'LastName': 'Nair', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom; Freeman Hospital, Newcastle upon Tyne, United Kingdom. Electronic address: Sukumaran.Nair@gjnh.scot.nhs.uk.'}, {'ForeName': 'Catherine D', 'Initials': 'CD', 'LastName': 'Sudarshan', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Thorpe', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Jeshika', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Health Economics Research Group, Brunel University London, London, United Kingdom.'}, {'ForeName': 'Thasee', 'Initials': 'T', 'LastName': 'Pillay', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Catarino', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Kamen', 'Initials': 'K', 'LastName': 'Valchanov', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Codispoti', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Abu-Omar', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Narain', 'Initials': 'N', 'LastName': 'Moorjani', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Matthews', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Freeman', 'Affiliation': 'Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Fox-Rushby', 'Affiliation': 'Health Economics Research Group, Brunel University London, London, United Kingdom.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Sharples', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Keppel Street, London, United Kingdom.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2018.05.057']
3279,31939768,Intergroup anxiety in pain care: impact on treatment recommendations made by white providers for black patients.,"Race disparities in pain care are well-documented. Given that most black patients are treated by white providers, patient-provider racial discordance is one hypothesized contributor to these disparities. Research and theory suggest that providers' trait-level intergroup anxiety impacts their state-level comfort while treating patients, which, in turn, impacts their pain treatment decisions. To test these hypothesized relationships, we conducted a planned secondary analysis of data from a randomized controlled trial of a perspective-taking intervention to reduce pain treatment disparities. Mediation analyses were conducted on treatment decision data from white providers for black virtual patients with chronic pain. Results indicated that white providers with higher trait-level intergroup anxiety reported lower state-level comfort treating black patients and were thereby more likely to recommend opioid (indirect effect = 0.76, 95% confidence interval [CI]: 0.21-1.51) and pain specialty (indirect effect = 0.91, 95% CI: 0.26-1.78) treatments and less likely to recommend nonopioid analgesics (indirect effect = -0.45, 95% CI: -0.94 to -0.12). Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy. This study provides important new information about intrapersonal and interpersonal contributors to race disparities in chronic pain care. These findings suggest that intergroup anxiety and the resulting situational discomfort encroach on the clinical decision-making process by influencing white providers' decisions about which pain treatments to recommend to black patients. Should these findings be replicated in future studies, they would support interventions to help providers become more aware of their trait-level intergroup anxiety and manage their state-level reactions to patients who are racially/ethnically different from themselves.",2020,Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy.,"['Black virtual patients with chronic pain', 'White providers for Black patients']",['perspective-taking intervention'],['pain specialty'],"[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0745156,Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy.,"[{'ForeName': 'Alexis D', 'Initials': 'AD', 'LastName': 'Grant', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Hollingshead', 'Affiliation': 'Department of Family Medicine, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Anastas', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Pain,['10.1097/j.pain.0000000000001806']
3280,31992217,"Effects of a smartphone-based videoconferencing program for older nursing home residents on depression, loneliness, and quality of life: a quasi-experimental study.","BACKGROUND


Smartphones can optimize the opportunities for interactions between nursing home residents and their families. However, the effectiveness of smartphone-based videoconferencing programs in enhancing emotional status and quality of life has not been explored. The purpose of this study was to evaluate of the effect of a smartphone-based videoconferencing program on nursing home residents' feelings of loneliness, depressive symptoms and quality of life.
METHODS


This study used a quasi-experimental research design. Older residents from seven nursing homes in Taiwan participated in this study. Nursing homes (NH) were randomly selected as sites for either the intervention group (5 NH) or the control group (2 NH); NH residents who met the inclusion criteria were invited to participate. The intervention group was comprised of 32 participants; the control group was comprised of 30 participants. The intervention group interacted with their family members once a week for 6 months using a smartphone and a ""LINE"" application (app). Data were collected with self-report instruments: subjective feelings of loneliness, using the University of California Los Angeles Loneliness Scale; depressive symptoms, using the Geriatric Depression Scale; and quality of life using the SF-36. Data were collected at four time points (baseline, and at 1-month, 3-months and 6-months from baseline). Data were analysed using the generalized estimating equation approach.
RESULTS


After the intervention, as compared to those in the control group, participants in interventional group had significant decreases in baseline loneliness scores at 1 months (β = - 3.41, p < 0.001), 3 months (β = - 5.96, p < 0.001), and 6 months (β = - 7.50, p < 0.001), and improvements in physical role (β = 36.49, p = 0.01), vitality (β = 13.11, p < 0.001) and pain scores (β = 16.71, p = 0.01) at 6 months. However, changes in mean depression scores did not significantly differ between groups.
CONCLUSIONS


Smartphone-based videoconferencing effectively improved residents' feelings of loneliness, and physiological health, vitality and pain, but not depressive symptoms. Future investigations might evaluate the effectiveness of other media-based technologies in nursing homes as well as their effectiveness within and between different age cohorts.",2020,"The intervention group interacted with their family members once a week for 6 months using a smartphone and a ""LINE"" application (app).","['older nursing home residents', 'nursing home residents and their families', 'Nursing homes (NH) were randomly selected as sites for either the intervention group (5 NH) or the control group (2 NH); NH residents who met the inclusion criteria were invited to participate', 'Older residents from seven nursing homes in Taiwan participated in this study']","['smartphone-based videoconferencing programs', 'smartphone-based videoconferencing program', 'Smartphone-based videoconferencing', 'smartphone and a ""LINE"" application (app']","['baseline loneliness scores', 'depression, loneliness, and quality of life', 'physical role', 'loneliness, depressive symptoms and quality of life', 'emotional status and quality of life', ""residents' feelings of loneliness, and physiological health, vitality and pain"", 'pain scores', 'subjective feelings of loneliness, using the University of California Los Angeles Loneliness Scale; depressive symptoms, using the Geriatric Depression Scale; and quality of life using the SF-36', 'mean depression scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0222045'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",32.0,0.0213089,"The intervention group interacted with their family members once a week for 6 months using a smartphone and a ""LINE"" application (app).","[{'ForeName': 'Hsiu-Hsin', 'Initials': 'HH', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, 259, Wen-Hwa 1st Road, Kwei-Shan, Tao-Yuan, Republic of China. kitty@mail.cgu.edu.tw.'}, {'ForeName': 'Ching-Yu', 'Initials': 'CY', 'LastName': 'Cheng', 'Affiliation': 'College of Nursing, Chang Gung University of Science and Technology, Chia-Yi, Republic of China.'}, {'ForeName': 'Wann-Yun', 'Initials': 'WY', 'LastName': 'Shieh', 'Affiliation': 'Department of Computer Science and Information Engineering, Chang Gung University, Tao-Yuan, Republic of China.'}, {'ForeName': 'Yue-Cune', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Mathematics, Tamkang University, New Taipei City, Republic of China.'}]",BMC geriatrics,['10.1186/s12877-020-1426-2']
3281,32056811,The effectiveness of foot reflexology in reducing anxiety and duration of labor in primiparas: An open-label randomized controlled trial.,"BACKGROUND AND PURPOSE


Reflexology alleviates anxiety and may shorten the duration of labor. We evaluated the effect of reflexology on anxiety level and duration of labor in primiparas with moderate-to-severe anxiety.
MATERIALS AND METHODS


In this open-label randomized-controlled trial, primiparas with moderate-to-severe anxiety were randomized into one of two groups: addition of reflexology to usual care, or usual care only. The primary outcome was a change in the level of anxiety during reflexology treatment.
RESULTS


Ninety-nine women were assigned to reflexology treatment while ninety received usual care only. A larger alleviation of anxiety was observed immediately after reflexology treatment as compared to the control group during the 30 min following group assignment. Reflexology did not affect the length of delivery.
CONCLUSION


Foot reflexology had a positive short-term anxiolytic effect during labor in primiparas with moderate-to-severe anxiety but did not affect the duration of labor.",2020,A larger alleviation of anxiety was observed immediately after reflexology treatment as compared to the control group during the 30 min following group assignment.,"['primiparas', 'primiparas with moderate-to-severe anxiety', 'Ninety-nine women']","['Reflexology', 'foot reflexology', 'reflexology to usual care, or usual care only', 'reflexology']","['anxiety and duration of labor', 'alleviation of anxiety', 'anxiety level and duration of labor', 'level of anxiety', 'length of delivery', 'positive short-term anxiolytic effect']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0016504', 'cui_str': 'Foot'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3179404', 'cui_str': 'Antianxiety Effects'}]",99.0,0.0638573,A larger alleviation of anxiety was observed immediately after reflexology treatment as compared to the control group during the 30 min following group assignment.,"[{'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Levy', 'Affiliation': 'Internal Medicine B Department, Bnai-Zion Medical Center, Haifa, Israel. Electronic address: ilana.levy@b-zion.org.il.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Attias', 'Affiliation': 'Complementary and Integrative Medicine Service, Bnai-Zion Medical Center, Haifa, Israel; School of Public Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Stern Lavee', 'Affiliation': 'Intensive Cardiac Care Unit, HaEmek Medical Center, Afula, Israel.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Avneri', 'Affiliation': 'Complementary and Integrative Medicine Service, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Cohen', 'Affiliation': 'Obstetric Unit, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Shosh', 'Initials': 'S', 'LastName': 'Balachsan', 'Affiliation': 'Obstetric Unit, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Sagi', 'Affiliation': 'Obstetric Unit, Bnai-Zion Medical Center, Haifa, Israel; Rappaport Faculty of Medicine, The Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Schiff', 'Affiliation': 'Internal Medicine B Department, Bnai-Zion Medical Center, Haifa, Israel; Complementary and Integrative Medicine Service, Bnai-Zion Medical Center, Haifa, Israel; Rappaport Faculty of Medicine, The Technion-Israel Institute of Technology, Haifa, Israel.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101085']
3282,32056812,Comparison of the effects of stabilization exercise plus kinesio taping and stabilization exercise alone on pain and well-being in fibromyalgia.,"PURPOSE


To compare the effects of spinal stabilization exercise (SSE) plus kinesio taping (KT) and SSE alone on pain and well-being in women with fibromyalgia (FM).
MATERIAL AND METHODS


Patients with FM were randomly allocated into SSE (n:19) and SSE + KT (n:17) groups. Pain and fatigue with Visual Analog Scale, health status with Fibromyalgia Impact Questionnaire, quality of life (QoL) with Nottingham Health Profile, depression with Beck Depression Inventory, sleep quality with Jenkins Sleep Scale were assessed. SSE and KT with fascial correction technique were carried out 2 days a week for 6 weeks.
RESULTS


SSE + KT was more effective in decreasing pain and fatigue, and improving some parameters related to health status and the QoL compared to SSE alone (p < 0.05). After treatment, pain, depression, health status, QoL, and sleep quality improved in both groups (p < 0.05).
CONCLUSIONS


SSE with KT was superior for improving pain and general well-being compared to SSE alone.",2020,"SSE + KT was more effective in decreasing pain and fatigue, and improving some parameters related to health status and the QoL compared to SSE alone (p < 0.05).","['women with fibromyalgia (FM', 'Patients with FM']","['spinal stabilization exercise (SSE) plus kinesio taping (KT) and SSE alone', 'SSE', 'SSE\xa0+\xa0KT', 'stabilization exercise plus kinesio taping and stabilization exercise alone', 'SSE and KT with fascial correction technique']","['pain and fatigue', 'Pain and fatigue with Visual Analog Scale, health status with Fibromyalgia Impact Questionnaire, quality of life (QoL) with Nottingham Health Profile, depression with Beck Depression Inventory, sleep quality with Jenkins Sleep Scale', 'pain, depression, health status, QoL, and sleep quality', 'pain and well-being in fibromyalgia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0222045'}]",,0.0391437,"SSE + KT was more effective in decreasing pain and fatigue, and improving some parameters related to health status and the QoL compared to SSE alone (p < 0.05).","[{'ForeName': 'Seyda', 'Initials': 'S', 'LastName': 'Toprak Celenay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Ankara Yildirim Beyazit University Ankara, Turkey. Electronic address: sydtoprak@hotmail.com.'}, {'ForeName': 'Oguzhan', 'Initials': 'O', 'LastName': 'Mete', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Ankara Yildirim Beyazit University Ankara, Turkey. Electronic address: fztoguzhanmete06@gmail.com.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Akan', 'Affiliation': 'Department of Internal Medicine, Ankara City Hospital, Ankara, Turkey. Electronic address: dr_selcukakan@hotmail.com.'}, {'ForeName': 'Necmiye', 'Initials': 'N', 'LastName': 'Un Yildirim', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Gulhane Health Sciences Faculty, Health Science University, Ankara, Turkey. Electronic address: necmiyeu@yahoo.com.'}, {'ForeName': 'Sukran', 'Initials': 'S', 'LastName': 'Erten', 'Affiliation': 'Department of Rheumatology, Ankara City Hospital, Ankara Yildirim Beyazit University, Ankara, Turkey. Electronic address: sukranerten@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101076']
3283,32048131,Utility of N-acetylcysteine in ischemic hepatitis in cirrhotics with acute variceal bleed: a randomized controlled trial.,"BACKGROUND AND AIMS


Ischemic hepatitis (IH) following acute variceal bleed (AVB) carries an ominous prognosis. N-Acetylcysteine (NAC), a potent anti-oxidant, may prevent IH by improving tissue oxygen delivery and improving hepatic hypoxia.
METHODS


Consecutive cirrhotics with AVB were prospectively randomized to receive either standard of care (SOC) plus NAC intravenously for 72 h(at 150 mg/kg/h for 1 h followed by 12.5 mg/kg/h for 4 h, followed by 6.25 mg/kg for 67 h) (Group A, n = 107) or SOC alone (Group B, n = 107).
RESULTS


Baseline characteristics were comparable. IH developed more frequently in Gr.B 25(23%) than A-15(14%); p = 0.08). Incidence of IH increased with severity of liver disease. Binary logistic regression analysis showed reduced incidence of IH in Gr.A than B [odds ratio (OR) 0.33, 0.11-0.93] patients after controlling for other significant factors. The incidence of acute kidney injury (AKI) was also reduced in Gr.A [OR 0.34, 0.15-0.75]. Development of IH was significantly associated with increased deaths due to liver failure at 6 weeks [subdistribution hazard ratio (SHR) 21.6, 7.4-62.8]. On multivariate competing risk analysis, significantly lower deaths due to liver failure (SHR 0.33, 0.11-0.97) were noted in Gr.A than B.
CONCLUSIONS


One in five patients with acute variceal bleed develops ischemic hepatitis which is associated with worse outcomes. NAC therapy averts deaths due to liver failure by preventing IH and reduces AKI and is, therefore, recommended for cirrhotics with acute variceal bleed.
TRIAL REGISTRATION


Clinicaltrials.gov no: NCT02015403.",2020,"On multivariate competing risk analysis, significantly lower deaths due to liver failure (SHR 0.33, 0.11-0.97) were noted in Gr.","['h(at', 'Consecutive cirrhotics with AVB', 'cirrhotics with acute variceal bleed', 'five patients with acute variceal bleed develops ischemic hepatitis']","['NAC therapy', 'standard of care (SOC) plus NAC', 'SOC alone', 'N-Acetylcysteine (NAC', 'N-acetylcysteine']","['incidence of acute kidney injury (AKI', 'Incidence of IH increased with severity of liver disease', 'deaths due to liver failure']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0473117', 'cui_str': 'Ischemic hepatitis (disorder)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}]",,0.376313,"On multivariate competing risk analysis, significantly lower deaths due to liver failure (SHR 0.33, 0.11-0.97) were noted in Gr.","[{'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Maiwall', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.'}, {'ForeName': 'Awinash', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.'}, {'ForeName': 'Ajeet Singh', 'Initials': 'AS', 'LastName': 'Bhadoria', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Research, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Jaswinder Singh', 'Initials': 'JS', 'LastName': 'Maras', 'Affiliation': 'Department of Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Sharma', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.'}, {'ForeName': 'Barjesh Chandra', 'Initials': 'BC', 'LastName': 'Sharma', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India. shivsarin@gmail.com.'}]",Hepatology international,['10.1007/s12072-020-10013-5']
3284,31356475,Lactated Ringer's Versus 4% Albumin on Lactated Ringer's in Early Sepsis Therapy in Cancer Patients: A Pilot Single-Center Randomized Trial.,"OBJECTIVE


To investigate the effects of the administration of 4% albumin on lactated Ringer's, when compared with lactated Ringer's alone, in the early phase of sepsis in cancer patients.
DESIGN


Single-center, randomized, double-blind, controlled-parallel trial.
SETTING


A tertiary care university cancer hospital.
PATIENTS


Cancer patients with severe sepsis or septic shock.
INTERVENTIONS


Between October 2014 and December 2016, patients were randomly assigned to receive either bolus of albumin in a lactated Ringer's solution or lactated Ringer's solution alone during the first 6 hours of fluid resuscitation after intensive care medicine (ICU) admission. Primary outcome was defined as death from any cause at 7 days. Secondary outcomes were defined as death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay.
MEASUREMENTS AND MAIN RESULTS


A total of 360 patients were enrolled in the trial. At 7 days, 46 of 180 patients (26%) died in the albumin group and 40 of 180 (22%) died in the lactated Ringer's group (p = 0.5). At 28 days, 96 of 180 patients (53%) died in the albumin group and 83 of 180 (46%) died in the lactated Ringer's group (p = 0.2). No significant differences in secondary outcomes were observed.
CONCLUSIONS


Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.",2019,Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.,"['Cancer patients with severe sepsis or septic shock', 'A tertiary care university cancer hospital', 'Cancer Patients', 'Between October 2014 and December 2016, patients', 'cancer patients with sepsis', '360 patients were enrolled in the trial', 'cancer patients']","[""Lactated Ringer's"", ""lactated Ringer's"", ""lactated Ringer's solution or lactated Ringer's solution alone"", ""Lactated Ringer's Versus 4% Albumin"", 'bolus of albumin', ""lactated Ringer's alone"", '4% albumin']","['death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay', '7-day survival', 'death from any cause at 7 days']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",360.0,0.565631,Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.,"[{'ForeName': 'Clarice Hyesuk Lee', 'Initials': 'CHL', 'LastName': 'Park', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Juliano Pinheiro', 'Initials': 'JP', 'LastName': 'de Almeida', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gisele Queiroz', 'Initials': 'GQ', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Stéphanie Itala', 'Initials': 'SI', 'LastName': 'Rizk', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Julia Tizue', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rosana Ely', 'Initials': 'RE', 'LastName': 'Nakamura', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Matheus Moraes', 'Initials': 'MM', 'LastName': 'Mourão', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Filomena Regina Barbosa Gomes', 'Initials': 'FRBG', 'LastName': 'Galas', 'Affiliation': 'Division of Anesthesia, Heart Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Abdala', 'Affiliation': 'Department of Infectious Diseases, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Maristela', 'Initials': 'M', 'LastName': 'Pinheiro Freire', 'Affiliation': 'Department of Infectious Diseases, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Department of Cardiopneumology, Heart Institute, Faculty of Medicine, University of Sao Paulo, Brazil.'}, {'ForeName': 'Jose Otavio', 'Initials': 'JO', 'LastName': 'Costa Auler', 'Affiliation': 'Division of Anesthesia, Heart Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Nardelli', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, GA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Ludhmila Abrahao', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Critical care medicine,['10.1097/CCM.0000000000003900']
3285,32049887,Velocity Loss as a Critical Variable Determining the Adaptations to Strength Training.,"PURPOSE


This study aimed to compare the effects of four resistance training (RT) programs with different velocity loss (VL) thresholds: 0% (VL0), 10% (VL10), 20% (VL20), and 40% (VL40) on sprint and jump performance, muscle strength, neuromuscular, muscle hypertrophy, and architectural adaptations.
METHODS


Sixty-four young resistance-trained men were randomly assigned into four groups (VL0, VL10, VL20, and VL40) that differed in the VL allowed in each set. Subjects followed an RT program for 8 wk (two sessions per week) using the full-squat (SQ) exercise, with similar relative intensity (70%-85% 1-repetition maximum), number of sets (3), and interset recovery period (4 min). Before and after the RT program, the following tests were performed: 1) muscle hypertrophy and architecture of the vastus lateralis (VLA), 2) tensiomyography, 3) 20-m running sprint, 4) vertical jump, 5) maximal voluntary isometric contraction in SQ, 6) progressive loading test in SQ, and 7) fatigue test.
RESULTS


No between-group differences existed for RT-induced gains in sprint, jump, and strength performance despite the differences in the total volume performed by each group. VL20 and VL40 showed significant increases (P < 0.001) in muscle hypertrophy (group-time interaction, P = 0.06). However, only VL40 exhibited a significant slowing (P < 0.001) of the delay time in the VLA muscle (group-time interaction, P = 0.05). Moreover, VL40 showed a significant decrease in the early rate of force development (P = 0.04).
CONCLUSIONS


Higher VL thresholds (i.e., VL20 and VL40) maximized hypertrophic adaptations, although an excessive VL during the set (i.e., VL40) may also induce negative neuromuscular adaptations. Therefore, moderate VL thresholds should be chosen to maximize strength adaptations and to prevent negative neuromuscular adaptations.",2020,"RESULTS


No between-group differences existed for RT-induced gains in sprint, jump and strength performance despite the differences in the total volume performed by each group.",['Sixty-four young resistance-trained men'],"['full-squat (SQ) exercise', 'tensiomyography; 3) 20-m running sprint; 4) vertical jump; 5) maximal voluntary isometric contraction in SQ; 6) progressive loading test in SQ; and 7) fatigue test', 'four resistance training (RT']","['RT-induced gains in sprint, jump and strength performance', 'Velocity Loss', 'early rate of force development', 'muscle hypertrophy', 'sprint and jump performance, muscle strength, neuromuscular, muscle hypertrophy and architectural adaptations']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy (finding)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]",64.0,0.0229249,"RESULTS


No between-group differences existed for RT-induced gains in sprint, jump and strength performance despite the differences in the total volume performed by each group.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': 'Physical Performance & Sports Research Center, Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, SPAIN.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Alcazar', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, SPAIN.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'SÁnchez-ValdepeÑas', 'Affiliation': 'Physical Performance & Sports Research Center, Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, SPAIN.'}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Cornejo-Daza', 'Affiliation': 'Physical Performance & Sports Research Center, Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, SPAIN.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Piqueras-Sanchiz', 'Affiliation': 'Physical Performance & Sports Research Center, Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, SPAIN.'}, {'ForeName': 'RaÚl', 'Initials': 'R', 'LastName': 'Mora-Vela', 'Affiliation': 'Physical Performance & Sports Research Center, Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, SPAIN.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'SÁnchez-Moreno', 'Affiliation': 'Department of Physical Education and Sports, University of Seville, Seville, SPAIN.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Bachero-Mena', 'Affiliation': 'Department of Physical Education and Sports, University of Seville, Seville, SPAIN.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ortega-Becerra', 'Affiliation': 'Physical Performance & Sports Research Center, Sports and Computers Sciences, Universidad Pablo de Olavide, Seville, SPAIN.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Alegre', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, SPAIN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002295']
3286,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3287,32043205,Communicating cardiovascular risk to high-risk cancer survivors: a mixed-methods pilot study of a statin risk communication tool.,"PURPOSE


Childhood, adolescent, and young adult cancer survivors treated with radiation therapy (RT) may be unaware of their high cardiovascular disease (CVD) risk or how to mitigate it. Tools are needed to improve understanding. We developed and pilot-tested a risk communication tool for shared decision-making with survivors regarding CVD risk reduction with statin therapy. We included quantitative and qualitative arms to further tool development and testing.
METHODS


The statin risk communication tool was adapted from a previously validated tool. Patients were at increased risk for CVD due to history of chest RT and recruited to usual care and intervention arms. The post-visit survey included Likert-like scales to explore acceptability of the tool, knowledge questions, and a decisional conflict scale. This pilot study used descriptive statistics and was not powered for significance. Semi-structured interviews with intervention arm participants explored shared decision-making processes.
RESULTS


Median participant (n = 46) age was 45. Most intervention patients (22/24, 92%) and 50% (11/22) of controls found statin information acceptable while 31% (7/22) of the control arm selected ""not applicable"" regarding information acceptability. Most participants were unaware of their personal CVD risk or potential statin side effects. In semi-structured interviews, participants found the tool is helpful to visualize risk and aid conversations.
CONCLUSIONS


The risk communication tool was acceptable. Qualitative data suggested the tool improved decisional clarity and comfort.
IMPLICATIONS FOR CANCER SURVIVORS


Poor knowledge of CVD and statins and poor recall of CVD risk conversation suggest a need to continue to optimize conversations regarding cardiovascular risk and statin therapy.",2020,"Most intervention patients (22/24, 92%) and 50% (11/22) of controls found statin information acceptable while 31% (7/22) of the control arm selected ""not applicable"" regarding information acceptability.","['young adult cancer survivors treated with', 'high-risk cancer survivors', '46) age was 45']","['radiation therapy (RT', 'statin therapy']","['personal CVD risk or potential statin side effects', 'decisional clarity and comfort', 'Likert-like scales to explore acceptability of the tool, knowledge questions, and a decisional conflict scale']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}]",,0.0297871,"Most intervention patients (22/24, 92%) and 50% (11/22) of controls found statin information acceptable while 31% (7/22) of the control arm selected ""not applicable"" regarding information acceptability.","[{'ForeName': 'Nirupa J', 'Initials': 'NJ', 'LastName': 'Raghunathan', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA. raghunan@mskcc.org.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Zabor', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Oeffinger', 'Affiliation': 'Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Tonorezos', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Korenstein', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00860-4']
3288,31994751,"Comparison of posterior-stabilized, cruciate-retaining, and medial-stabilized knee implant motion during gait.","Accurate knowledge of knee joint motion is needed to evaluate the effects of implant design on functional performance and component wear. We conducted a randomized controlled trial to measure and compare 6-degree-of-freedom (6-DOF) kinematics and femoral condylar motion of posterior-stabilized (PS), cruciate-retaining (CR), and medial-stabilized (MS) knee implant designs for one cycle of walking. A mobile biplane X-ray imaging system was used to accurately measure 6-DOF tibiofemoral motion as patients implanted with PS (n = 23), CR (n = 25), or MS (n = 26) knees walked over ground at their self-selected speeds. Knee flexion angle did not differ significantly between the three designs. Relative movements of the femoral and tibial components were generally similar for PS and CR with significant differences observed only for anterior tibial drawer. Knee kinematic profiles measured for MS were appreciably different: external rotation and abduction of the tibia were increased while peak-to-peak anterior drawer was significantly reduced for MS compared with PS and CR. Anterior-posterior drawer and medial-lateral shift of the tibia were strongly coupled to internal-external rotation for MS, as was anterior-posterior translation of the contact center in the lateral compartment. MS exhibited the least amount of paradoxical anterior translation of the femur relative to the tibia during knee flexion. The joint center of rotation in the transverse plane was located in the lateral compartment for PS and CR and in the medial compartment for MS. Substantial differences were evident in 6-DOF knee kinematics between the healthy knee and all three prosthetic designs. Overall, knee kinematic profiles observed for MS resemble those of the healthy joint more closely than PS and CR.",2020,"Knee flexion angle (maximum, minimum, and peak-to-peak range) did not differ significantly between the three designs.","['one cycle of walking', 'patients implanted with PS (n = 23), CR (n = 25) or MS (n = 26) knees walked over ground at their self-selected speeds']","['6-degree-of-freedom (6-DOF) kinematics and femoral condylar motion of posterior-stabilized (PS), cruciate-retaining (CR) and medial-stabilized (MS) knee implant designs', 'Posterior-stabilized, Cruciate-retaining, and Medial-stabilized Knee Implant Motion during Gait']","['6-DOF tibiofemoral motion', 'Knee kinematic profiles', 'peak-to-peak anterior drawer', 'Knee flexion angle (maximum, minimum, and peak-to-peak range', 'external rotation and abduction of the tibia', '6-DOF knee kinematics', 'Relative movements of the femoral and tibial components']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0453897', 'cui_str': 'Drawers (physical object)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",26.0,0.028844,"Knee flexion angle (maximum, minimum, and peak-to-peak range) did not differ significantly between the three designs.","[{'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Gray', 'Affiliation': 'Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Shanyuanye', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Tony J', 'Initials': 'TJ', 'LastName': 'Young', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Dowsey', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Choong', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Pandy', 'Affiliation': 'Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24613']
3289,2145718,[A plasma subunit vaccine against hepatitis B studied in field trials].,"The work presents materials on the study of subunit plasma vaccine against hepatitis B (HB), developed in the USSR, in a controlled epidemiological trial. The study showed low reactogenicity and complete safety of the preparation, the level of anti-HBsAg antibodies in persons, formerly found to have no such antibodies, being 88% after three injections of the vaccine. To determine the prophylactic effectiveness of the vaccine, the test and control groups, each consisting of 500 children, were formed from children aged 1-3 years, i.e. belonging to the age group most frequently affected by HB, by the method of random choice. During 18 months from the time of immunization no cases of HB were registered among the vaccinees, while in the control group 5 cases of HB were registered (8.9 per 1000). These results indicate that the plasma vaccine against HB, newly developed in the USSR, is faintly reactogenic, safe and shows sufficiently high antigenic activity and protective potency correlating with this activity.",1990,"During 18 months from the time of immunization no cases of HB were registered among the vaccinees, while in the control group 5 cases of HB were registered (8.9 per 1000).","['500 children, were formed from children aged 1-3 years, i.e. belonging to the age group most frequently affected by HB, by the method of random choice']",['vaccine'],['prophylactic effectiveness'],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0254288,"During 18 months from the time of immunization no cases of HB were registered among the vaccinees, while in the control group 5 cases of HB were registered (8.9 per 1000).","[{'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Ikoev', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gorbunov', 'Affiliation': ''}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': ""Anan'ev"", 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Sumarokov', 'Affiliation': ''}, {'ForeName': 'Sh Sh', 'Initials': 'ShSh', 'LastName': 'Shavakhabov', 'Affiliation': ''}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Khalitova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
3290,31856984,Combined phacoemulsification-viscosynechialysis-trabeculotomy vs phacotrabeculectomy in uncontrolled primary angle-closure glaucoma with cataract.,"PURPOSE


To compare the effect on intraocular pressure (IOP) of phacoemulsification combined with viscosynechialysis and trabeculotomy with that of phacoemulsification combined with trabeculectomy in eyes with primary angle-closure glaucoma (PACG) and visually significant cataract.
SETTING


Mansoura Ophthalmic Center, Mansoura University, Egypt.
DESIGN


Prospective case series.
METHODS


This prospective randomized study included patients with uncontrolled PACG and visually significant cataract presenting between 2012 and 2017. The eyes were randomized to phacoemulsification combined with viscosynechialysis and trabeculotomy (phaco-viscosynechialysis group) or phacoemulsification combined with trabeculectomy (phacotrabeculectomy group). Success (true and qualified) (IOP <18 mm Hg without sight-threatening complications) was studied 24 months postoperatively. Intraoperative complications were noted. The primary outcome measure was the IOP before and after surgery.
RESULTS


The study comprised 59 eyes of 59 patients with a mean age of 59.8 years ± 6.8 (SD) in the phaco-viscosynechialysis group (30 eyes) and 60.3 ± 6.3 years in the phacotrabeculectomy group (29 eyes) (P = .704). The mean preoperative IOP was 28.7 ± 2.14 mm Hg in the phaco-viscosynechialysis group and 28.5 ± 2.11 mm Hg in the phacotrabeculectomy group; the mean at 24 months was 14.5 ± 2.8 mm Hg and 17.3 ± 2.2 mm Hg, respectively (P < .001). The total success rate at 24 months was 90% and 83%, respectively.
CONCLUSION


Although both techniques were relatively safe and effective in reducing IOP for at least 2 years in eyes with PACG, combined phacoemulsification-viscosynechialysis-trabeculotomy gave better outcomes.",2019,Intraoperative complications were noted.,"['eyes with primary angle-closure glaucoma (PACG) and visually significant cataract', '59 eyes of 59 patients with a mean age of 59.8\xa0years\xa0±\xa06.8 (SD) in the phaco-viscosynechialysis group (30 eyes) and 60.3\xa0±\xa06.3\xa0years in the phacotrabeculectomy group (29 eyes', 'patients with uncontrolled PACG and visually significant cataract presenting between 2012 and 2017', 'uncontrolled primary angle-closure glaucoma with cataract', 'Mansoura Ophthalmic Center, Mansoura University, Egypt']","['phacoemulsification combined with viscosynechialysis and trabeculotomy (phaco-viscosynechialysis group) or phacoemulsification combined with trabeculectomy (phacotrabeculectomy group', 'phacoemulsification combined with viscosynechialysis and trabeculotomy', 'phacoemulsification combined with trabeculectomy', 'Combined phacoemulsification-viscosynechialysis-trabeculotomy vs phacotrabeculectomy']","['Intraoperative complications', 'intraocular pressure (IOP', 'IOP', 'total success rate', 'Success (true and qualified', 'mean preoperative IOP', 'IOP before and after surgery']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}]","[{'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}]","[{'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.096004,Intraoperative complications were noted.,"[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Elwehidy', 'Affiliation': 'Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Nader H L', 'Initials': 'NHL', 'LastName': 'Bayoumi', 'Affiliation': 'Faculty of Medicine, Alexandria University, Egypt. Electronic address: naderbayoumi@yahoo.com.'}, {'ForeName': 'Amani E', 'Initials': 'AE', 'LastName': 'Badawi', 'Affiliation': 'Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Sherein M', 'Initials': 'SM', 'LastName': 'Hagras', 'Affiliation': 'Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Kamel', 'Affiliation': 'Faculty of Medicine, Mansoura University, Egypt.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.07.031']
3291,31411373,Postprandial Responses of Serum Bile Acids in Healthy Humans after Ingestion of Turmeric before Medium/High-Fat Breakfasts.,"SCOPE


Bile acids (BAs) are known to regulate a number of metabolic activities in the body. However, very little is known about how BAs are affected by diet. This study aims to investigate whether a single dose of turmeric-based beverage (TUR) before ingestion of medium- (MF) or high-fat (HF) breakfasts would improve the BA profile in healthy subjects.
METHODS AND RESULTS


Twelve healthy subjects are assigned to a randomized crossover single-blind study. The subjects receive isocaloric MF or HF breakfasts after a drink containing flavored water with or without an extract of turmeric with at least 1-week wash-out period between the treatments. Postprandial BAs are measured using protein precipitation followed by ultra-high-performance liquid chromatography-mass spectrometry analysis. The concentration of BAs is generally higher after HF than MF breakfasts. Ingestion of TUR before MF breakfast increases the serum concentrations of free and conjugated forms of cholic (CA) and ursodeoxycholic acids (UDCA), as well as the concentrations of chenodeoxycholic acid (CDCA) and its taurine-conjugated forms. However, the concentration of conjugated forms of deoxycholic acid (DCA) decreases when TUR is taken before HF breakfast.
CONCLUSION


TUR ingestion before MF and HF breakfasts improve BA profiles and may therefore have potential health-promoting effects on BA metabolism.",2019,"Ingestion of TUR before MF breakfast increases the serum concentrations of free and conjugated forms of cholic (CA) and ursodeoxycholic acids (UDCA), as well as the concentrations of chenodeoxycholic acid (CDCA) and its taurine-conjugated forms.","['healthy subjects', 'Twelve healthy subjects', 'Healthy Humans after Ingestion of Turmeric before Medium/High-Fat Breakfasts']","['turmeric-based beverage (TUR) before ingestion of medium- (MF) or high-fat (HF) breakfasts', 'TUR ingestion before MF and HF breakfasts', 'isocaloric MF or HF breakfasts']","['BA profile', 'serum concentrations of free and conjugated forms of cholic (CA) and ursodeoxycholic acids (UDCA', 'Postprandial BAs', 'concentration of BAs', 'Postprandial Responses of Serum Bile Acids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0041356', 'cui_str': 'Tumeric'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0041356', 'cui_str': 'Tumeric'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}]",12.0,0.0335485,"Ingestion of TUR before MF breakfast increases the serum concentrations of free and conjugated forms of cholic (CA) and ursodeoxycholic acids (UDCA), as well as the concentrations of chenodeoxycholic acid (CDCA) and its taurine-conjugated forms.","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ghaffarzadegan', 'Affiliation': 'Food for Health Science Centre, Kemicentrum, Lund University, P.O. Box 124, SE-221 00, Lund, Sweden.'}, {'ForeName': 'Yoghatama Cindya', 'Initials': 'YC', 'LastName': 'Zanzer', 'Affiliation': 'Food for Health Science Centre, Kemicentrum, Lund University, P.O. Box 124, SE-221 00, Lund, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Östman', 'Affiliation': 'Food for Health Science Centre, Kemicentrum, Lund University, P.O. Box 124, SE-221 00, Lund, Sweden.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Hållenius', 'Affiliation': 'Food for Health Science Centre, Kemicentrum, Lund University, P.O. Box 124, SE-221 00, Lund, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Essén', 'Affiliation': 'Centre for Analysis and Synthesis, Department of Chemistry, Kemicentrum, Lund University, P.O. Box 124, SE-221 00, Lund, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Sandahl', 'Affiliation': 'Centre for Analysis and Synthesis, Department of Chemistry, Kemicentrum, Lund University, P.O. Box 124, SE-221 00, Lund, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Nyman', 'Affiliation': 'Food for Health Science Centre, Kemicentrum, Lund University, P.O. Box 124, SE-221 00, Lund, Sweden.'}]",Molecular nutrition & food research,['10.1002/mnfr.201900672']
3292,32035738,"Use of healthy conversation skills to promote healthy diets, physical activity and gestational weight gain: Results from a pilot randomised controlled trial.","OBJECTIVES


This study evaluated the use of Healthy Conversation Skills (a client-centered communication approach to behaviour change) in supporting women to achieve optimal gestational-weight-gain and health behaviours.
METHODS


Seventy pregnant women were randomised to the control or intervention group. Study visits and phone calls were delivered by Registered Dietitians (RDs) to women in the intervention and control groups. The intervention RD was trained in Healthy Conversation Skills while the control RD was not. Diet, physical activity and gestational-weight-gain were assessed at baseline and again at follow-up in the intervention and control groups.
RESULTS


Women in the intervention group improved their diet score between baseline and visit 2, while the control group did not. At 34 weeks, women in the control group reported being sedentary for longer than women in the intervention group. There were no differences in total gestational-weight-gain between the groups.
CONCLUSIONS


Pregnant women who interacted with an RD using Healthy Conversation Skills reported positive outcomes in health behaviours.
PRACTICE IMPLICATIONS


Healthy Conversation Skills shows promise as an approach to initiate, and maintain discussions promoting health behaviour change in pregnancy.",2020,"Diet, physical activity and gestational-weight-gain were assessed at baseline and again at follow-up in the intervention and control groups.
","['Seventy pregnant women', 'Pregnant women who interacted with an RD using Healthy Conversation Skills']","['Healthy Conversation Skills (a client-centered communication approach to behaviour change', 'healthy conversation skills']","['Diet, physical activity and gestational-weight-gain', 'total gestational-weight-gain', 'physical activity and gestational weight gain', 'diet score']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",70.0,0.0819398,"Diet, physical activity and gestational-weight-gain were assessed at baseline and again at follow-up in the intervention and control groups.
","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Adam', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, T6G 2H3, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jarman', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, T6G 2H3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barker', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Donna P', 'Initials': 'DP', 'LastName': 'Manca', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, T6G 2T4, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lawrence', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rhonda C', 'Initials': 'RC', 'LastName': 'Bell', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, T6G 2H3, Canada. Electronic address: Rhonda.bell@ualberta.ca.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.001']
3293,32035739,An educational intervention in rural Uganda: Risk-targeted home talks by village health workers.,"OBJECTIVE


Evaluate the effectiveness of home talks (HTs), a novel model of health education delivered by village health workers (VHWs) with primary-level education to rural African mothers. Talk recipients were assessed by health census to be at risk for ill-health in one of 5 ways: malnutrition, diarrhea, respiratory disease, HIV, and poverty due to family size.
METHODS


Each participant received a pre-test, immediate post-test and delayed post-test on their assigned HT topic and a pre-test and delayed post-test on a randomly assigned control topic. Differences in scoring were examined against controls and over time using paired t-tests and general linear regression analysis, respectively.
RESULTS


Subjects lost knowledge gained from the HTs over time, but what they retained at 3 months was far greater than what they learned about the control topics (p-values <0.0001), independent of subjects' educational level.
CONCLUSION


Targeted HTs to people with health census-identified risk factors resulted in learning and significant retention of knowledge.
PRACTICE IMPLICATIONS


Positive behavioral change resulting from health education has been shown in diverse contexts. This personal model of home talk education by VHWs targeting vulnerable families is flexible and effective and may be used to improve community health in other impoverished settings worldwide.",2020,This personal model of home talk education by VHWs targeting vulnerable families is flexible and effective and may be used to improve community health in other impoverished settings worldwide.,"['rural Uganda', 'rural African mothers', 'village health workers']","['pre-test, immediate post-test and delayed post-test on their assigned HT topic and a pre-test and delayed post-test', 'home talks (HTs), a novel model of health education delivered by village health workers (VHWs) with primary-level education', 'educational intervention']",[],"[{'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0087157', 'cui_str': 'Village Health Workers'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0018701'}, {'cui': 'C0087157', 'cui_str': 'Village Health Workers'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0476883,This personal model of home talk education by VHWs targeting vulnerable families is flexible and effective and may be used to improve community health in other impoverished settings worldwide.,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: cmoon@mail.einstein.yu.edu.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Alizadeh', 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital & Boston Medical Center, 300 Longwood Ave., Boston, MA, 02115, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: faraz.alizadeh@childrens.harvard.edu.""}, {'ForeName': 'Gloria Fung', 'Initials': 'GF', 'LastName': 'Chaw', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: gfungch@montefiore.org.'}, {'ForeName': 'Mary Immaculate', 'Initials': 'MI', 'LastName': 'Mulongo', 'Affiliation': 'Kisoro District Hospital, Kisoro, Uganda; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: immaculatemulongo5@gmail.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Schaefle', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: kenneth.schaefle@med.einstein.yu.edu.'}, {'ForeName': 'Morgen', 'Initials': 'M', 'LastName': 'Yao-Cohen', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: myaocoh@montefiore.org.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Musominalli', 'Affiliation': 'Kisoro District Hospital, Kisoro, Uganda; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: sammusominali@gmail.com.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Paccione', 'Affiliation': 'Department of Internal Medicine, Montefiore Medical Center, 111 E 210 St., The Bronx, NY, 10467, USA; Albert Einstein College of Medicine, 1300 Morris Park Ave., The Bronx, NY, 10461, USA; Doctors For Global Health, P.O. Box 1761 Decatur, GA, 30031, USA. Electronic address: gpaccion@montefiore.org.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.015']
3294,2201157,[Changes in the activity of the natural killers under the influence of genetically engineered alpha 2-interferon in patients with viral hepatitis B].,"The functional activity of natural killer cells (NKC) in 90 patients with acute viral hepatitis B was studied. As a result, the importance of this characteristic as a criterion of effectiveness of alpha 2-interferon obtained by gene engineering techniques was shown. The study revealed the presence of inverse relationship between the level of the functional activity of NKC and the severity of acute viral hepatitis B at the peak of the disease. The character of the influence of alpha 2-interferon on the cytotoxicity of NKC depended on the time of the use of the preparation. Administration of reaferon till day 7 of jaundice promoted a significant increase of the initially low activity of NKC in comparison with that in patients receiving common therapy. This was accompanied by rapid changes of the clinical signs of the disease and accelerated elimination of the virus from the blood. When the preparation was administered after day 6 of jaundice the activity of NKC increased slowly and only at the period of convalescence. These results recommend measurements of NKC activity as a criterion for the evaluation of the effectiveness of alpha 2-interferon.",1990,Administration of reaferon till day 7 of jaundice promoted a significant increase of the initially low activity of NKC in comparison with that in patients receiving common therapy.,"['patients with viral hepatitis B', '90 patients with acute viral hepatitis B was studied']","['reaferon', 'natural killer cells (NKC']","['initially low activity of NKC', 'cytotoxicity of NKC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0276622', 'cui_str': 'Acute viral hepatitis (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0073010', 'cui_str': 'Reaferon'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",90.0,0.0201701,Administration of reaferon till day 7 of jaundice promoted a significant increase of the initially low activity of NKC in comparison with that in patients receiving common therapy.,"[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Malinovskaia', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Murzabaeva', 'Affiliation': ''}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Bragina', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
3295,32035514,"Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Pembrolizumab plus pemetrexed-platinum led to superior overall survival and progression-free survival, and a higher proportion of patients with a confirmed complete or partial response over placebo plus pemetrexed-platinum in the KEYNOTE-189 study. We aimed to evaluate prespecified exploratory patient-reported outcomes (PROs) in patients in KEYNOTE-189.
METHODS


In the multicentre, double-blind, randomised, placebo-controlled, phase 3 KEYNOTE-189 study done at 126 cancer centres in 16 countries, eligible patients aged 18 years or older with histologically or cytologically confirmed metastatic non-squamous non-small-cell lung cancer without sensitising EGFR or ALK alterations, measurable disease as per Response Evaluation Criteria in Solid Tumors (version 1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled. Patients were randomly assigned (2:1) to receive intravenous pembrolizumab (200 mg) or saline placebo every 3 weeks for up to 2 years (35 cycles); all patients received four cycles of intravenous pemetrexed (500 mg/m 2 ) with carboplatin (5 mg/mL per min) or cisplatin (75 mg/m 2 ; investigator's choice) every 3 weeks for four cycles, followed by pemetrexed maintenance therapy every 3 weeks. Permuted block randomisation (block size six) was done with an interactive voice-response system and stratified by PD-L1 expression, choice of platinum, and smoking status. Patients, investigators, and other study personnel were unaware of treatment assignment. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13) were administered at cycles 1-5, every three cycles thereafter during year 1, and every four cycles during years 2-3. The primary endpoints (overall survival and progression-free survival) have been published previously. Key PRO endpoints were change from baseline to week 12 (during chemotherapy) and week 21 (following chemotherapy) in QLQ-C30 global health status/quality of life (GHS/QOL) score, and time to deterioration in cough, chest pain, or dyspnoea. PROs were analysed in all randomly assigned patients who received at least one dose of study medication and who completed at least one PRO assessment, and the results are provided with two-sided, nominal p values. This ongoing study is registered with ClinicalTrials.gov, number NCT02578680.
FINDINGS


Between Feb 26, 2016, and March 6, 2017, 616 patients were enrolled; median follow-up was 10·5 months (range 0·2-20·4) as of data cutoff on Nov 8, 2017. 402 (99%) of 405 patients in the pembrolizumab plus pemetrexed-platinum group and 200 (99%) of 202 patients in the placebo plus pemetrexed-platinum-treated group completed at least one PRO assessment. At baseline, 359 (89%) of 402 patients in the pembrolizumab plus pemetrexed-platinum group and 180 (90%) of 200 in the placebo plus pemetrexed-platinum group were compliant with QLQ-C30; at week 12, 319 (90%) of 354 and 149 (89%) of 167 patients were compliant, respectively; and at week 21, 249 (76%) of 326 and 91 (64%) of 143 patients were compliant, respectively. From baseline to week 12, GHS/QOL scores were maintained with both pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·0 point [95% CI -1·3 to 3·2] increase) and placebo plus pemetrexed-platinum (-2·6 points [-5·8 to 0·5] decrease; between-group difference: 3·6 points [-0·1 to 7·2]; p=0·053). From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014). Median time to deterioration in cough, chest pain, or dyspnoea was not reached (95% CI 10·2 months to not reached) with pembrolizumab plus pemetrexed-platinum, and was 7·0 months (4·8 months to not reached) with placebo plus pemetrexed-platinum (hazard ratio 0·81 [95% CI 0·60-1·09], p=0·16).
INTERPRETATION


The addition of pembrolizumab to standard chemotherapy maintained GHS/QOL, with improved GHS/QOL scores at week 21 in the pembrolizumab plus chemotherapy group compared with the placebo plus chemotherapy group. These data further support use of pembrolizumab plus pemetrexed-platinum as first-line therapy for patients with metastatic non-squamous non-small-cell lung cancer.
FUNDING


Merck Sharp & Dohme.",2020,"From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014).","['patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189', '126 cancer centres in 16 countries, eligible patients aged 18 years or older with histologically or cytologically confirmed metastatic non-squamous non-small-cell lung cancer without sensitising EGFR or ALK alterations, measurable disease as per Response Evaluation Criteria in Solid Tumors (version 1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled', 'patients with metastatic non-squamous non-small-cell lung cancer', 'Between Feb 26, 2016, and March 6, 2017', 'patients in KEYNOTE-189', '616 patients were enrolled; median follow-up was 10·5 months (range 0·2-20·4) as of data cutoff on Nov 8, 2017']","['pembrolizumab plus pemetrexed-platinum', 'pembrolizumab plus chemotherapy', 'saline placebo', 'pembrolizumab or placebo plus pemetrexed and platinum', 'intravenous pembrolizumab', 'placebo', 'Pembrolizumab plus pemetrexed-platinum', 'intravenous pemetrexed', 'placebo plus pemetrexed-platinum-treated group completed at least one PRO assessment', 'placebo plus chemotherapy', 'placebo plus pemetrexed-platinum', 'cisplatin', 'carboplatin', 'placebo-controlled', 'pembrolizumab']","['Median time to deterioration in cough, chest pain, or dyspnoea', 'QLQ-C30 global health status/quality of life (GHS/QOL) score, and time to deterioration in cough, chest pain, or dyspnoea', 'GHS/QOL scores', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",616.0,0.745602,"From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014).","[{'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: marina.garassino@istitutotumori.mi.it.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Gadgeel', 'Affiliation': 'Department of Medical Oncology 1, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Esteban', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Speranza', 'Affiliation': 'Centre Intégré de Cancérologie de la Montérégie, Hôpital Charles-Le Moyne, Greenfield Park, QC, Canada.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Hospital Universitario Fundación Jiménez Díaz (IIS-FJD), Madrid, Spain.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Vienna, Austria.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Sanford Health, Sioux Falls, SD, USA.'}, {'ForeName': 'Susanna Yee-Shan', 'Initials': 'SY', 'LastName': 'Cheng', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Helge G', 'Initials': 'HG', 'LastName': 'Bischoff', 'Affiliation': 'Thoraxklinik, Heidelberg, Germany.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Peled', 'Affiliation': 'Clalit Health Services, Soroka Medical Center, Beer-Sheeva, Israel.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burke', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30801-0']
3296,31432535,"Effects of cooperative learning on peer relations, empathy, and bullying in middle school.","Although researchers have developed prevention programs to reduce bullying, the results are mixed, and this may be due to a degree of uncertainty in their theoretical foundation. In particular, these programs share an emphasis on empathy as a personal attribute that can be enhanced among students through the application of specific curricula that will, in turn, contribute to a reduction in bullying behavior. However, the link between empathy and bullying is unclear, as is the ability of bullying prevention programs to actually impact student empathy. In this study, we used a cluster randomized trial (N = 15 middle schools, 1,890 students, 47.1% female, 75.2% White) to evaluate the impact of cooperative learning on bullying, and we evaluated whether these effects were mediated by empathy and peer relatedness. Our results indicated that cooperative learning can significantly reduce bullying, and that some of this effect is transmitted via enhancements to affective empathy. Cooperative learning also demonstrated significant positive effects on cognitive empathy, but this did not have an effect on bullying. We also found that the effects of cooperative learning on cognitive and affective empathy were mediated by improvements in peer relatedness. These findings add a degree of clarity to the literature, and also represent the first time, as far as we are aware, that an antibullying program has been found to have significant effects on both cognitive and affective empathy.",2019,"Cooperative learning also demonstrated significant positive effects on cognitive empathy, but this did not have an effect on bullying.","['cluster randomized trial (N\u2009=\u200915 middle schools, 1,890 students, 47.1% female, 75.2% White']",['cooperative learning'],"['cognitive empathy', 'cognitive and affective empathy', 'peer relations, empathy, and bullying in middle school']","[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}]",,0.0173503,"Cooperative learning also demonstrated significant positive effects on cognitive empathy, but this did not have an effect on bullying.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'Oregon Research Institute, Eugene, Oregon.'}, {'ForeName': 'Cary J', 'Initials': 'CJ', 'LastName': 'Roseth', 'Affiliation': 'Michigan State University, East Lansing, Michigan.'}]",Aggressive behavior,['10.1002/ab.21858']
3297,32034557,Are attentional instruction and feedback type affect on learning of postural and supra-postural tasks?,"Optimum postural control and balance is dependent on the individual, the environment, and the task limitations. Thus, the present study investigated the effect of attentional instruction and feedback type on postural and supra-postural tasks. The 96 participants aged 11-19 years with attention deficit hyperactivity disorder (ADHD) were randomly assigned to one of the eight groups such as attentional instruction (internal and external), feedback (external and internal), and task (postural and supra-postural). Following a pre-test, the participants underwent four training sessions. Each session included 20 trials of 30 s with 20 s of rest between trials. Twenty-four hours after the training session, they performed two trials of warm-up and then took part in a retention test. Twenty-four hours after the retention test, they again performed two trials of warm-up and then participated in the transfer test. The result showed that the external attentional feedback and external attentional instruction groups performed better on supra-postural and postural tasks than the other experimental groups (P > 0.05). The external attentional instruction group performed better on postural and supra-postural tasks in the delayed retention and transfer tests (P > 0.05). Also, the external feedback group scored highest on postural and supra-postural tasks in the delayed retention and transfer tests. The results suggest that external attentional feedback and instruction is more effective than internal attention when learning supra-postural tasks to maintain balance.",2020,The external attentional instruction group performed better on postural and supra-postural tasks in the delayed retention and transfer tests (P > 0.05).,['96 participants aged 11-19\xa0years with attention deficit hyperactivity disorder (ADHD'],"['external attentional feedback and external attentional instruction', 'attentional instruction (internal and external), feedback (external and internal), and task (postural and supra-postural', 'external attentional instruction', 'external attentional feedback and instruction', 'attentional instruction and feedback type on postural and supra-postural tasks']","['learning of postural and supra-postural tasks', 'supra-postural and postural tasks', 'postural and supra-postural tasks']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",96.0,0.0175054,The external attentional instruction group performed better on postural and supra-postural tasks in the delayed retention and transfer tests (P > 0.05).,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shams', 'Affiliation': 'Sport Science Research Institute (SSRI), Tehran, Iran. amirshams85@gmail.com.'}, {'ForeName': 'Parvaneh Shamsipour', 'Initials': 'PS', 'LastName': 'Dehkordi', 'Affiliation': 'Alzahra University, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Tahmasbi', 'Affiliation': 'Shahid Rajaee Teacher Training University, Tehran, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Sangari', 'Affiliation': 'Islamic Azad University, Chalus Branch, Chalus, Mazandaran, Iran.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04278-9']
3298,31727415,"Evaluation of the efficacy, safety, and clinically recommended dose of dienogest in the treatment of primary dysmenorrhea: a randomized, double-blind, multicenter, placebo-controlled study.","OBJECTIVE


To evaluate the efficacy, safety, and clinically recommended dose of dienogest (DNG; 0.5 mg/d, 1 mg/d, and 2 mg/d) in the treatment of primary dysmenorrhea.
DESIGN


A phase II, randomized, double-blind, multicenter, placebo-controlled study.
SETTING


Twenty study sites.
PATIENTS


A total of 235 patients with primary dysmenorrhea.
INTERVENTION(S)


Patients were randomized to receive orally a placebo, DNG (0.5 mg/d, 1 mg/d, or 2 mg/d) or ethinylestradiol 0.02 mg/drospirenone 3 mg (an open-label reference drug) for 12 weeks.
MAIN OUTCOME MEASURE(S)


The primary endpoint was the change from baseline in the dysmenorrhea score at week 12 of treatment. The secondary endpoint was the change from baseline in the visual analogue scale at week 12 of treatment. Subjects were assessed for lower abdominal pain and/or low back pain.
RESULTS


All DNG arms were superior to the placebo arm in terms of the change from baseline in the dysmenorrhea score. The results suggest an equal or greater effect of DNG 1 and 2 mg/d in relieving pain, when compared to the reference drug. In the safety profile of DNG, including irregular uterine bleeding, there was no obvious difference among the doses of DNG. A significant decrease in the serum estradiol concentration compared to that in the placebo arm was not observed in the DNG 1 mg/d arm but was observed in the DNG 2 mg/d arm.
CONCLUSION(S)


The results suggest that DNG at a dose of 1 mg/d is an effective and well-tolerated treatment for primary dysmenorrhea.
TRIAL REGISTRATION


JapicCTI-152977 (en).",2020,All DNG arms were superior to the placebo arm in terms of the change from baseline in the dysmenorrhea score.,"['235 patients with primary dysmenorrhea', 'primary dysmenorrhea', 'Twenty study sites']","['placebo, DNG', 'placebo', 'drospirenone', 'ethinylestradiol', 'DNG']","['dysmenorrhea score', 'serum estradiol concentration', 'efficacy, safety', 'irregular uterine bleeding', 'abdominal pain and/or low back pain', 'relieving pain', 'visual analogue scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}]","[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0156404', 'cui_str': 'Irregular Menses'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",235.0,0.41021,All DNG arms were superior to the placebo arm in terms of the change from baseline in the dysmenorrhea score.,"[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: yutakaos-tky@umin.ac.jp.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.09.014']
3299,31836291,Effect of intraperitoneal bupivacaine on postoperative pain in laparoscopic bariatric surgeries.,"BACKGROUND


Postoperative pain has many adverse effects and, if not properly controlled, it may lead to a wide range of complications. Opioids, as frequently used drugs for pain control, have some serious respiratory and gastrointestinal complications, especially in obese patients.
OBJECTIVES


In this study, we planned to evaluate the effect of intraperitoneal bupivacaine lavage on postoperative pain in laparoscopic bariatric surgeries.
SETTING


The study was conducted in Firoozgar Hospital (affiliated to Iran University of Medical Sciences), Tehran, Iran.
METHODS


In this clinical trial, 106 patients scheduled for laparoscopic bariatric surgery, randomly assigned to receive either intraperitoneal lavage with 50 mL of .2% bupivacaine or the same volume of normal saline during the operation. One-gram intravenous paracetamol was infused for all patients at the end of surgery, and all patients received intravenous paracetamol infusion for 1 day after surgery. Pain level, assessed by visual analog scale, was recorded at 1, 4, 8, and 24 hours after surgery. Total additive analgesics administered during the first day after surgery was also recorded.
RESULTS


The pain score during the first 24 hours after surgery decreased significantly in both groups, but comparing the groups showed that pain level at 1, 4, 8, and 24 hours after surgery in the bupivacaine group was significantly lower than the normal saline group (P < .05). Also, opioid consumption during 24 hours was significantly lower in the bupivacaine group (P < .001).
CONCLUSIONS


Intraperitoneal lavage with bupivacaine is an effective approach to control postoperative pain in obese patients undergoing laparoscopic bariatric surgery.",2020,"Also, opioid consumption during 24 hours was significantly lower in the bupivacaine group (P < .001).
","['laparoscopic bariatric surgeries', '106 patients scheduled for laparoscopic bariatric surgery', 'obese patients undergoing laparoscopic bariatric surgery', 'obese patients', 'The study was conducted in Firoozgar Hospital (affiliated to Iran University of Medical Sciences), Tehran, Iran']","['bupivacaine', 'intravenous paracetamol infusion', 'intraperitoneal lavage with 50 mL of .2% bupivacaine', 'paracetamol', 'intraperitoneal bupivacaine', 'intraperitoneal bupivacaine lavage']","['Total additive analgesics', 'opioid consumption', 'pain level', 'pain score', 'Pain level, assessed by visual analog scale', 'postoperative pain']","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",106.0,0.0576803,"Also, opioid consumption during 24 hours was significantly lower in the bupivacaine group (P < .001).
","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Safari', 'Affiliation': 'Department of General Surgery, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Rokhtabnak', 'Affiliation': 'Department of Anesthesia, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soudabeh', 'Initials': 'S', 'LastName': 'Djalali Motlagh', 'Affiliation': 'Department of Anesthesia, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghanbari Garkani', 'Affiliation': 'Department of Anesthesia, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Pournajafian', 'Affiliation': 'Department of Anesthesia, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran. Electronic address: pournajafian.ar@iums.ac.ir.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2019.10.028']
3300,31242340,Prescription Opioid Misuse After a Recent Sexual Assault: A Randomized Clinical Trial of a Video Intervention.,"BACKGROUND AND OBJECTIVES


Prescription opioid (PO) misuse is increasing and is associated with overdose. Individuals who experienced a recent sexual assault are at risk for increased substance use, yet limited interventions target PO misuse after sexual assault. The current study examined the efficacy of video interventions on PO misuse after sexual assault.
METHODS


Adolescent girls and women (n = 154) were recruited in the context of a sexual assault medical forensic exam in the emergency department. Effects of a prevention of post-rape stress (PPRS) video and a pleasant imagery and relaxation instruction (PIRI) video were compared with treatment as usual (TAU) during a sexual assault medical forensic exam on PO misuse. Participants reported if they had used POs for non-medical purposes since the sexual assault at 1.5 month follow-up.
RESULTS


Results from a logistic regression analysis indicated that participants with a prior sexual assault were less likely to misuse prescription opioids 1.5 months after the assault in the PIRI condition compared with TAU. There were no main effects for video condition and no interactions for the PPRS condition on PO misuse.
DISCUSSION AND CONCLUSIONS


Providing the PIRI video, or teaching other types of mindfulness or relaxation exercises, may be warranted as a secondary prevention for individuals during the sexual assault medical forensic exam for those with a prior sexual assault history.
SCIENTIFIC SIGNIFICANCE


This research provides an initial examination of the impact of mindfulness skills recently after traumatic event exposure on PO misuse. (Am J Addict 2019;28:376-381).",2019,"RESULTS


Results from a logistic regression analysis indicated that participants with a prior sexual assault were less likely to misuse prescription opioids 1.5 months after the assault in the PIRI condition compared with TAU.",['Adolescent girls and women (n\u2009=\u2009154) were recruited in the context of a sexual assault medical forensic exam in the emergency department'],"['video interventions', 'Video Intervention', 'prevention of post-rape stress (PPRS) video and a pleasant imagery and relaxation instruction (PIRI) video', 'Prescription Opioid Misuse', 'PIRI video, or teaching other types of mindfulness or relaxation exercises']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise (regime/therapy)'}]",[],154.0,0.0275664,"RESULTS


Results from a logistic regression analysis indicated that participants with a prior sexual assault were less likely to misuse prescription opioids 1.5 months after the assault in the PIRI condition compared with TAU.","[{'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gilmore', 'Affiliation': 'Department of Nursing, College of Nursing, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychology, Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Frazier', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ledray', 'Affiliation': 'SANE SART Resource Service, Watertown, MN.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Department of Nursing, College of Nursing, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Department of Nursing, College of Nursing, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Kilpatrick', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Resnick', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}]",The American journal on addictions,['10.1111/ajad.12922']
3301,32005971,Effectiveness of intraoperative intraocular lens use on improving surgical safety for dense cataract phacoemulsification: a randomized controlled trial.,"We designed this study to assess if surgical safety can be improved by intraoperative use of intraocular lens (IOL) for cataract phacoemulsification. We performed phacoemulsification cataract removal on 401 patients. We randomly assigned these patients into three groups: the standard setting (Group I, n = 134), with reduced vacuum and flow rate (Group II, n = 137), and with IOL insertion before the last quadrant was emulsified with standard setting (Group III, n = 130). The primary outcomes included the risk of posterior capsular rupture (PCR), ultrasound time, energy, and complications. The secondary outcomes included central corneal thickness (CCT), CCT changes, endothelial cells (ETC) counting, ETC loss, and the best corrected distance visual acuity (BCVA) measured on day 1, day 7 and day 30. If PCR occurred, we emulsified the residual lens materials after insertion of IOL and clean of the prolapsed vitreous. We found that the risk of PCR in Group III (0/130) was lower than Group I (9/134, corrected relative risk (RR) = 18.44, 95% CI: 1.08-313.56) and Group II (3/137, corrected RR = 6.64, 95% CI: 0.35-27.41). Group III showed better BCVA on day 1 and 7, less ECC loss on day 7 and 30, and less CCT increase on day 1 and 7. No cases converted to extracapsular cataract extraction. No residual lens materials misdirected into vitreous cavity. Intraoperative use of IOL can improve surgical safety for dense cataract phacoemulsification.",2020,"We found that the risk of PCR in Group III (0/130) was lower than Group I (9/134, corrected relative risk (RR) = 18.44, 95% CI: 1.08-313.56) and Group II (3/137, corrected RR = 6.64, 95% CI: 0.35-27.41).","['dense cataract phacoemulsification', 'cataract phacoemulsification', '401 patients']","['intraoperative intraocular lens', 'intraocular lens (IOL', 'IOL', 'phacoemulsification cataract removal']","['risk of posterior capsular rupture (PCR), ultrasound time, energy, and complications', 'surgical safety', 'central corneal thickness (CCT), CCT changes, endothelial cells (ETC) counting, ETC loss, and the best corrected distance visual acuity (BCVA', 'extracapsular cataract extraction', 'risk of PCR', 'ECC loss']","[{'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1626910', 'cui_str': 'Posterior capsular tear'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0197726', 'cui_str': 'Extracapsular extraction of lens (procedure)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]",401.0,0.0585254,"We found that the risk of PCR in Group III (0/130) was lower than Group I (9/134, corrected relative risk (RR) = 18.44, 95% CI: 1.08-313.56) and Group II (3/137, corrected RR = 6.64, 95% CI: 0.35-27.41).","[{'ForeName': 'Mingbing', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-sen University, Guangzhou, 510060, P.R. China. zengmingbing@126.com.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Graduate center for Vision Research, SUNY College of Optometry, New York City, NY10036, USA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-sen University, Guangzhou, 510060, P.R. China.'}, {'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Health Promotion, College of Dentistry, New York University, New York City, New York, 10010, USA.'}, {'ForeName': 'Yunxin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Hainan Eye Hospital and Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou, 570311, P.R. China.'}, {'ForeName': 'Xialin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-sen University, Guangzhou, 510060, P.R. China.'}]",Scientific reports,['10.1038/s41598-020-58597-0']
3302,31718828,Comparing the individual effects of metformin and rosiglitazone and their combination in obese women with polycystic ovary syndrome: a randomized controlled trial.,"OBJECTIVE


To compare the effects of metformin, rosiglitazone, and their combination in obese polycystic ovary syndrome (PCOS) patients with insulin resistance.
DESIGN


Prospective randomized controlled trail.
SETTING


Tertiary teaching hospital.
PATIENT(S)


Obese Chinese women (body mass index [BMI] ≥25 kg/m 2 ) with insulin resistance who fulfilled the Rotterdam criteria of PCOS.
INTERVENTION(S)


In group 1, 68 patients administered metformin (1,500 mg/day); in group 2, 67 patients administered rosiglitazone (4 mg/day); in group 3, 69 patients administered metformin (1,000 mg/day) and rosiglitazone (4 mg/day) for 6 months, all with the same diet and regular exercise lifestyle recommendation.
MAIN OUTCOME MEASURE(S)


Average menstrual interval, anthropometric measurements, androgen-related parameters, and metabolic features of insulin, carbohydrates, and lipids, with intention-to-treat analysis.
RESULT(S)


The baseline parameters showed no statistically significant differences. After the 6-month treatment, most participants showed an improved menstrual pattern. There were statistically significant decreases in acne scores, weight, BMI, waist circumference, waist-to-hip ratio, and serum testosterone. The metabolic indexes of insulin, carbohydrates, and lipids were improved obviously compared with the baseline in each group. Among the three groups, the patients administered 1,500 mg/day metformin experienced greater reductions in weight. However, the rosiglitazone users (alone or combined with metformin) showed a more notable decline in total cholesterol and triglyceride levels.
CONCLUSION(S)


Considering the benefits of metformin on weight loss, high-dose metformin (1,500 mg/day) along with lifestyle modification should be recommended for obese, insulin-resistant women with PCOS. Rosiglitazone alone or combined with low-dosage metformin plus lifestyle modification should be considered for the women with abnormal lipid profiles.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR-TRC-13003642 (Chinese Clinical Trial Registry).",2020,"There were statistically significant decreases in acne scores, weight, BMI, waist circumference, waist-to-hip ratio, and serum testosterone.","['obese women with polycystic ovary syndrome', 'obese polycystic ovary syndrome (PCOS) patients with insulin resistance', '\n\n\nObese Chinese women (body mass index [BMI] ≥25 kg/m 2 ) with insulin resistance who fulfilled the Rotterdam criteria of PCOS', 'Tertiary teaching hospital', 'women with abnormal lipid profiles', 'obese, insulin-resistant women with PCOS']","['Rosiglitazone alone or combined with low-dosage metformin', 'regular exercise lifestyle recommendation', 'metformin', 'metformin, rosiglitazone', 'metformin and rosiglitazone', 'rosiglitazone']","['menstrual pattern', 'total cholesterol and triglyceride levels', 'Average menstrual interval, anthropometric measurements, androgen-related parameters, and metabolic features of insulin, carbohydrates, and lipids, with intention-to-treat analysis', 'weight loss', 'weight', 'metabolic indexes of insulin, carbohydrates, and lipids', 'acne scores, weight, BMI, waist circumference, waist-to-hip ratio, and serum testosterone']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0740400', 'cui_str': 'Abnormal lipid profile'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1620263', 'cui_str': 'Metformin / rosiglitazone'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}]",69.0,0.14659,"There were statistically significant decreases in acne scores, weight, BMI, waist circumference, waist-to-hip ratio, and serum testosterone.","[{'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Qiuyi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Changling', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, Sichuan, People's Republic of China. Electronic address: weihuang64@163.com.""}]",Fertility and sterility,['10.1016/j.fertnstert.2019.09.011']
3303,31525271,New technique to reduce systemic side effects of timolol eye drops: The tissue press method-Cross-over clinical trial.,"IMPORTANCE


Nasolacrimal occlusion (NLO) is effective in reducing systemic absorption of eye drop medication but it is difficult and often performed poorly. We propose an alternative easier and equally effective technique.
BACKGROUND


To test the effectiveness of systemic absorption, we evaluated plasma concentration and ocular effects after topically administered timolol and compared to NLO.
DESIGN


Cross-over trial carried out in Capital Eye Specialist, Wellington.
PARTICIPANTS


A total of 21 subjects over 18 years without contraindications for topical beta-blocker medication and not using systemic beta-blockers.
METHODS


During three clinic visits separated by at least one week, alternative approaches to reduce systemic eye drop absorption were tested. These were: (a) nasolacrimal (punctal) occlusion for 5 min, (b) tissue press method or (c) no intervention. Timolol plasma levels were measured 1 h after drop application. At each visit, baseline measurement of blood pressure, heart rate and intraocular pressure (IOP) were performed, and repeated 1 h after timolol 0.5% eye drop application.
MAIN OUTCOME MEASURES


Comparison of timolol plasma concentration after each intervention. Secondary outcome measurements included effects on blood pressure, heart rate and IOP.
RESULTS


Plasma timolol concentrations after tissue press method and NLO were significantly lower than those without intervention. Comparing tissue press method to NLO, there were no significant differences in plasma levels of timolol, blood pressure, heart rate or IOP.
CONCLUSION AND RELEVANCE


The tissue press method is equally effective as NLO in reducing systemic absorption of timolol. It is also easier and faster to administer.",2020,"RESULTS


Plasma timolol concentrations after tissue press method and nasolacrimal occlusion were significantly lower than those without intervention.",['21 subjects over 18\u2009years without contraindications for topical beta-blocker medication and not using systemic beta-blockers'],"['timolol eye drops', 'timolol']","['systemic side effects', 'Timolol plasma levels', 'nasolacrimal occlusion', 'plasma levels of timolol, blood pressure, heart rate, or intraocular pressure', 'blood pressure, heart rate and intraocular pressure', 'plasma concentration and ocular effects']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",21.0,0.0537535,"RESULTS


Plasma timolol concentrations after tissue press method and nasolacrimal occlusion were significantly lower than those without intervention.","[{'ForeName': 'Luzia', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'Private Practice, Capital Eye Specialists, Wellington, New Zealand.'}, {'ForeName': 'Berit P', 'Initials': 'BP', 'LastName': 'Jensen', 'Affiliation': 'Department of Toxicology, Specialist Biochemistry, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Research Consultancy, Medignition INC, Zurich, Switzerland.'}, {'ForeName': 'Dickson', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Private Practice, Capital Eye Specialists, Wellington, New Zealand.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Wells', 'Affiliation': 'Private Practice, Capital Eye Specialists, Wellington, New Zealand.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13642']
3304,31722381,A randomized controlled trial of cardiac resynchronization therapy in patients with prolonged atrioventricular interval: the REAL-CRT pilot study.,"AIMS


A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms).
METHODS AND RESULTS


We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13-0.98), P = 0.046].
CONCLUSION


Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up.
CLINICAL TRIAL REGISTRATION


URL: http://clinicaltrials.gov/ Identifier: NCT02150538.",2020,"On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291).","['patients with prolonged atrioventricular interval', '82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220\u2009ms to CRT or to DDD-VPA', 'patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220\u2009ms']","['cardiac resynchronization therapy', 'Cardiac resynchronization therapy', 'cardiac resynchronization therapy (CRT']","['left ventricular end-systolic volume', 'E wave deceleration time', 'ejection fraction', 'functional class', 'mitral wave amplitude ratio', 'Left atrial volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0520877', 'cui_str': 'PR interval feature'}, {'cui': 'C0011037', 'cui_str': 'Dichlorodiphenyldichloroethane'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}]","[{'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",82.0,0.119111,"On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291).","[{'ForeName': 'Giovanni Luca', 'Initials': 'GL', 'LastName': 'Botto', 'Affiliation': 'U.O. Electrophysiology, ASST Rhodense, Rho-Garbagnate Milanese (MI), Italy.'}, {'ForeName': 'Assunta', 'Initials': 'A', 'LastName': 'Iuliano', 'Affiliation': 'Clinica San Michele, via Montella 16, 81024 Maddaloni (CE), Italy.'}, {'ForeName': 'Eraldo', 'Initials': 'E', 'LastName': 'Occhetta', 'Affiliation': 'Ospedale Maggiore Della Carità, Novara, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Belotti', 'Affiliation': 'A.O. Treviglio Caravaggio (BG), Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Russo', 'Affiliation': 'U.O. Electrophysiology, ASST Rhodense, Rho-Garbagnate Milanese (MI), Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Campari', 'Affiliation': 'Boston Scientific Italy, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Valsecchi', 'Affiliation': 'Boston Scientific Italy, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Stabile', 'Affiliation': 'Clinica San Michele, via Montella 16, 81024 Maddaloni (CE), Italy.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz321']
3305,31727694,Clinical implications of incidental venous thromboembolism in cancer patients.,"INTRODUCTION


In cancer patients, current guidance suggests similar treatment for incidental and symptomatic venous thromboembolism (VTE), mainly based on retrospective data. We aimed to evaluate anticoagulant therapy in cancer patients with incidental and symptomatic VTE.
METHODS


The Hokusai VTE Cancer Study was a randomised controlled trial comparing edoxaban with dalteparin for cancer-associated VTE. The primary outcome was the composite of first recurrent VTE or major bleeding. Secondary outcomes included major bleeding, recurrent VTE and mortality. Outcomes in patients with incidental and symptomatic VTE were evaluated during the 12-month study period.
RESULTS


331 patients with incidental VTE and 679 patients with symptomatic VTE were enrolled, of whom the index event was confirmed by an independent radiologist. Median durations of anticoagulant treatment were 195 and 189 days, respectively. In patients with incidental VTE, the primary outcome occurred in 12.7% of patients, major bleeding in 6.6% of patients and recurrent VTE in 7.9% of patients. Out of the 26 VTE recurrences in patients with incidental VTE, five (31%) were incidental, seven (44%) were symptomatic and four (25%) were deaths for which pulmonary embolism could not be ruled out. In patients with symptomatic VTE, the primary outcome occurred in 13.8% of patients, major bleeding in 4.9% of patients and recurrent VTE in 10.9% of patients. All-cause mortality was similar in both groups.
CONCLUSION


Clinical adverse outcomes are substantial in both cancer patients with incidental and symptomatic VTE, supporting current guideline recommendations that suggest treating incidental VTE in the same manner as symptomatic VTE.",2020,"In patients with symptomatic VTE, the primary outcome occurred in 13.8%, major bleeding in 4.9%, and recurrent VTE in 10.9% of patients.","['331 patients with incidental VTE and 679 with symptomatic VTE', 'cancer-associated VTE', 'cancer patients', 'cancer patients with incidental and symptomatic VTE', 'patients with incidental and symptomatic VTE']","['dalteparin', 'edoxaban', 'anticoagulant therapy']","['Median durations of anticoagulant treatment', 'major bleeding', 'composite of first recurrent VTE or major bleeding', 'recurrent VTE', 'major bleeding, recurrent VTE, and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0206461', 'cui_str': 'Dalteparin'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",331.0,0.0716066,"In patients with symptomatic VTE, the primary outcome occurred in 13.8%, major bleeding in 4.9%, and recurrent VTE in 10.9% of patients.","[{'ForeName': 'Frits I', 'Initials': 'FI', 'LastName': 'Mulder', 'Affiliation': 'Dept of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands f.i.mulder@amc.nl.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Di Nisio', 'Affiliation': ""Dept of Medicine and Ageing Sciences, University G. D'Annunzio, Chieti, Italy.""}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Ay', 'Affiliation': 'Dept of Medicine I, Clinical Division of Haematology and Haemostaseology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Dept of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Floris T M', 'Initials': 'FTM', 'LastName': 'Bosch', 'Affiliation': 'Dept of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Segers', 'Affiliation': 'ITREAS, Academic Research Organization, Amsterdam, The Netherlands.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Kraaijpoel', 'Affiliation': 'Dept of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Dept of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Tzu-Fei', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'Dept of Internal Medicine, Division of Hematology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Middeldorp', 'Affiliation': 'Dept of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Raskob', 'Affiliation': 'University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City, OK, USA.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Dept of Radiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Büller', 'Affiliation': 'Dept of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'van Es', 'Affiliation': 'Dept of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",The European respiratory journal,['10.1183/13993003.01697-2019']
3306,31919889,Efficacy of tildrakizumab by patient demographic and disease characteristics across a phase 2b and 2 phase 3 trials in patients with moderate-to-severe chronic plaque psoriasis.,"BACKGROUND


Tildrakizumab is a high-affinity, anti-interleukin-23p19 monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasis.
OBJECTIVES


To evaluate the effects of patient demographic and disease characteristics on tildrakizumab efficacy using phase 2b/3 trial data.
METHODS


Data from patients who received placebo, or tildrakizumab 100 or 200 mg, in P05495 [NCT01225731], reSURFACE 1 [NCT01722331] and reSURFACE 2 [NCT01729754] were analysed. Patient subgroups were defined by age, sex, race, weight, self-reported psoriatic arthritis, failure of ≥1 traditional systemic treatment and prior biologic use. Percentage of Psoriasis Area and Severity Index (PASI) 75 and 90 responders at Week 12 were compared across treatment arms in each subgroup. Absolute PASI at Weeks 0 and 12 was also determined for each subgroup.
RESULTS


Among patients randomized in P05495 (N = 355), reSURFACE 1 (N = 772) and 2 (N = 1090), percentage of PASI 75 and 90 responders were significantly greater for each tildrakizumab dose vs. placebo (P < 0.0001). PASI 75 and 90 responder percentages were numerically greater in patients <65 years of age, bodyweight ≤90 kg, without psoriatic arthritis and with no prior biologic exposure (only PASI 90), vs. their counterparts in corresponding subgroups. There were no clear or consistent differences in efficacy between the other subgroups. Absolute PASI scores were generally similar across subgroups.
CONCLUSIONS


Small numerical differences in tildrakizumab efficacy were observed between subgroups defined by patient age and weight, presence of psoriatic arthritis and prior biologic use. These differences were not clinically meaningful; however, analyses of long-term data may be of value. Tildrakizumab efficacy did not differ with respect to patient sex or race, or number of prior failed conventional systemic treatments. Overall, these results suggest tildrakizumab may be appropriate for treatment of moderate-to-severe plaque psoriasis in patients with a range of demographic and disease characteristics.",2020,"PASI 75 and 90 responder percentages were numerically greater in patients <65 years of age, body weight ≤90 kg, without psoriatic arthritis, and with no prior biologic exposure (only PASI 90), vs. their counterparts in corresponding subgroups.","['patients with a range of demographic and disease characteristics', 'patients with moderate to severe chronic plaque psoriasis']","['placebo, or tildrakizumab', 'tildrakizumab', 'tildrakizumab dose vs. placebo']","['Tildrakizumab efficacy', 'tildrakizumab efficacy', 'Absolute PASI', 'Percentage of Psoriasis Area and Severity Index (PASI', 'Absolute PASI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1090.0,0.0713936,"PASI 75 and 90 responder percentages were numerically greater in patients <65 years of age, body weight ≤90 kg, without psoriatic arthritis, and with no prior biologic exposure (only PASI 90), vs. their counterparts in corresponding subgroups.","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Université Laval, Hôpital Hôtel-Dieu de Québec, Québec City, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ramon', 'Affiliation': 'Department of Dermatology, Rambam Health Campus, Haifa, Israel.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rosoph', 'Affiliation': 'North Bay Dermatology Centre, North Bay, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Medical Dermatology Specialists, Inc., Atlanta, GA, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parno', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Rozzo', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Center for Clinical Studies, Webster, TX, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16187']
3307,31498950,Prospective study of aflibercept for the treatment of persistent macular oedema secondary to retinal vein occlusions in eyes not responsive to long-term treatment with bevacizumab or ranibizumab.,"IMPORTANCE


To examine the effect of switching from intravitreal bevacizumab or ranibizumab to aflibercept in eyes with persistent macular oedema due to retinal vein occlusion (RVO).
BACKGROUND


We report the results of a prospective interventional study on the effect of aflibercept 2 mg in eyes with persistent macular oedema after long-term treatment with bevacizumab or ranibizumab.
DESIGN


Non-randomized, prospective clinical trial.
PARTICIPANTS


Eighteen eyes of eighteen patients were included.
METHODS


Eyes with persistent macular oedema despite a minimum of four previous intravitreal bevacizumab/ranibizumab injections were recruited into this 48-week trial. Three loading doses of intravitreal aflibercept were administered every 4-weeks, thereafter every 8-weeks until week 48.
MAIN OUTCOME MEASURES


Mean change from baseline in best corrected visual acuity (BCVA) as measured by early treatment diabetic retinopathy score (ETDRS) and central macular thickness (CMT) as measured by spectral domain optical coherence tomography (SD-OCT) at 48 weeks.
RESULTS


Patients had received a mean of 40.0 ± 17.8 bevacizumab/ranibizumab intravitreal injections prior to switching to aflibercept. The mean number of previous injections administered in the 12-months preceding entry into the study was 10.2 ± 2.4. Mean vision change at week 48 was +21.1 ± 5.1 ETDRS letters in the BRVO group and +18.8 ± 5.9 letters at in the CRVO group (P < .001 for both groups). Mean decrease in CMT was 87.6 ± 48.8 μm and 191.0 ± 128.3 μm, in the BRVO and CRVO groups, respectively (P < .001). Using linear regression analyses, a higher number of previous intravitreal ranibizumab/bevacizumab injections and thicker pre-switch CMT were correlated with greater visual gains.
CONCLUSION AND RELEVANCE


Switching to aflibercept from bevacizumab or ranibizumab in eyes with persistent macular oedema due to RVO can lead to functional and anatomical improvement. This effect was more obvious in eyes with a greater CMT prior to the switch.",2020,Mean vision change at week 48 was +21.1 ± 5.1 ETDRS letters in the BRVO group and + 18.8 ± 5.9 letters at in the CRVO group (P < 0.001 for both groups).,"['Eyes with persistent macular oedema despite a minimum of 4 previous intravitreal', 'eyes with persistent macular oedema due to retinal vein occlusion (RVO', 'Patients had received a mean of 40.0\u2009±\u200917.8', 'persistent macular oedema secondary to retinal vein occlusions in eyes not responsive to long-term treatment with', 'Eighteen eyes of eighteen patients were included', 'eyes with persistent macular oedema after long-term treatment with']","['ranibizumab/bevacizumab', 'bevacizumab or ranibizumab', 'bevacizumab/ranibizumab intravitreal injections', 'bevacizumab or ranibizumab to aflibercept', 'aflibercept', 'bevacizumab/ranibizumab injections', 'intravitreal aflibercept']","['visual gains', 'diabetic retinopathy score (ETDRS) and central macular thickness (CMT', 'corrected visual acuity (BCVA', 'mean number of previous injections', 'Mean vision change', 'Mean decrease in CMT']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0035328', 'cui_str': 'Retinal Vein Occlusion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4060225', 'cui_str': 'ranibizumab Injection [Lucentis]'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",,0.121668,Mean vision change at week 48 was +21.1 ± 5.1 ETDRS letters in the BRVO group and + 18.8 ± 5.9 letters at in the CRVO group (P < 0.001 for both groups).,"[{'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Spooner', 'Affiliation': 'Sydney Retina, Sydney, New South Wales, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Fraser-Bell', 'Affiliation': 'Sydney Retina, Sydney, New South Wales, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Sydney Retina, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Sydney Retina, Sydney, New South Wales, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13636']
3308,25573533,Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer.,"BACKGROUND


Olaparib (Lynparza) is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor that induces synthetic lethality in cancers with homologous recombination defects.
PATIENTS AND METHODS


In this phase I, dose-escalation trial, patients with advanced solid tumours received olaparib (50-200 mg capsules b.i.d.) continuously or intermittently (days 1-14, per 28-day cycle) plus gemcitabine [i.v. 600-800 mg/m(2); days 1, 8, 15, and 22 (cycle 1), days 1, 8, and 15 (subsequent cycles)] to establish the maximum tolerated dose. A separate dose-escalation phase evaluated olaparib in tablet formulation (100 mg o.d./b.i.d.; days 1-14) plus gemcitabine (600 mg/m(2)). In an expansion phase, patients with genetically unselected locally advanced or metastatic pancreatic cancer were randomised 2 : 1 to the tolerated olaparib capsule combination dose or gemcitabine alone (1000 mg/m(2)).
RESULTS


Sixty-six patients were treated [dose-escalation phase, n = 44 (tablet cohort, n = 12); dose-expansion phase, n = 22 (olaparib plus gemcitabine, n = 15; gemcitabine alone, n = 7)]. In the dose-escalation phase, four patients (6%) experienced dose-limiting toxicities (raised alanine aminotransferase, n = 2; neutropenia, n = 1; febrile neutropenia, n = 1). Grade ≥3 adverse events were reported in 38/47 patients (81%) treated with olaparib capsules plus gemcitabine; most common were haematological toxicities (55%). Tolerated combinations were olaparib 100 mg b.i.d. capsule (intermittently, days 1-14) plus gemcitabine 600 mg/m(2) and olaparib 100 mg o.d. tablet (intermittently, days 1-14) plus gemcitabine 600 mg/m(2). There were no differences in efficacy observed during the dose-expansion phase.
CONCLUSIONS


Olaparib 100 mg b.i.d. (intermittent dosing; capsules) plus gemcitabine 600 mg/m(2) is tolerated in advanced solid tumour patients, with no unmanageable/unexpected toxicities. Continuous dosing of olaparib or combination with gemcitabine at doses >600 mg/m(2) was not considered to have an acceptable tolerability profile for further study.
CLINICALTRIALSGOV


NCT00515866.",2015,"There were no differences in efficacy observed during the dose-expansion phase.
","['patients with genetically unselected locally advanced or metastatic pancreatic cancer', 'cancers with homologous recombination defects', 'patients with locally advanced/metastatic pancreatic cancer', 'patients with advanced solid tumours and comparison with', 'patients with advanced solid tumours received']","['olaparib (50-200 mg capsules b.i.d', 'gemcitabine 600 mg/m(2) and olaparib 100 mg o.d', 'gemcitabine', 'olaparib capsules plus gemcitabine', 'gemcitabine alone', 'poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor', 'olaparib plus gemcitabine', 'Olaparib (Lynparza', 'olaparib or combination with gemcitabine', 'Olaparib', 'tolerated olaparib capsule combination dose or gemcitabine alone']","['efficacy', 'toxicities', 'dose-limiting toxicities (raised alanine aminotransferase, n = 2; neutropenia, n = 1; febrile neutropenia', 'haematological toxicities', 'Grade ≥3 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4520026', 'cui_str': 'olaparib 100 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032405', 'cui_str': 'Poly(ADPR) Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3872110', 'cui_str': 'Lynparza'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",66.0,0.0257923,"There were no differences in efficacy observed during the dose-expansion phase.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'Drug Development Unit, Sarah Cannon Research Institute/Tennessee Oncology, Nashville. Electronic address: jbendell@tnonc.com.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hochster', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, New Haven, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fielding', 'Affiliation': 'Global Medicines Development, AstraZeneca.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Burke', 'Affiliation': 'Clinical Pharmacology, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Burris', 'Affiliation': 'Drug Development Unit, Sarah Cannon Research Institute/Tennessee Oncology, Nashville.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu581']
3309,31960259,Game On-Complier Average Causal Effect Estimation Reveals Sleeper Effects on Academic Attainment in a Randomized Trial of the Good Behavior Game.,"To examine the efficacy of the Good Behavior Game (GBG) in improving children's reading attainment, and the extent to which this varies as a function of cumulative intervention intensity (dosage) and timing of outcome measurement. A 2-year cluster-randomized controlled trial was conducted. Seventy-seven primary schools from three regions in England were randomly assigned to intervention and control groups. Children (N = 3084) aged 67 at baseline were the target cohort. The GBG is an interdependent group-contingency behavior management strategy used by teachers in elementary schools. Reading attainment was assessed via national teacher assessment scores at baseline, and the Hodder Group Reading Test at post-test and 1-year post-intervention follow-up. Dosage was assessed using a bespoke online GBG scoreboard system. Multi-level intent-to-treat (ITT) and complier average causal effect (CACE) estimation were utilized. At post-test, no effects of the GBG on children's reading attainment were found in either the ITT or CACE models. At 1-year follow-up, results remained null in the ITT model, but a significant intervention effect was found among moderate compliers (Δ = 0.10) in the CACE model. The GBG can produce measurable improvements in children's academic attainment, but these effects may take time to become apparent and are contingent upon implementation dosage falling within an optimal range. The project was supported by funding from the Education Endowment Foundation and the National Institute for Health Research. ISRCTN: 64152096.",2020,"At post-test, no effects of the GBG on children's reading attainment were found in either the ITT or CACE models.","['Children (N\u2009=\u20093084) aged 67 at baseline were the target cohort', 'Seventy-seven primary schools from three regions in England']","['GBG', 'Good Behavior Game (GBG']","[""children's reading attainment""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0036883', 'cui_str': 'Sex Steroid-Binding Protein'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",,0.0411025,"At post-test, no effects of the GBG on children's reading attainment were found in either the ITT or CACE models.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ashworth', 'Affiliation': 'Manchester Institute of Education, University of Manchester, Oxford Road, Manchester, UK. e.l.ashworth@ljmu.ac.uk.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Panayiotou', 'Affiliation': 'Manchester Institute of Education, University of Manchester, Oxford Road, Manchester, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Humphrey', 'Affiliation': 'Manchester Institute of Education, University of Manchester, Oxford Road, Manchester, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hennessey', 'Affiliation': 'Manchester Institute of Education, University of Manchester, Oxford Road, Manchester, UK.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01074-6']
3310,1719716,[The characteristics of the reactogenicity and immunological activity of a new cholera bivalent chemical vaccine based on the results of controlled trials].,"The reactogenic properties and immunological potency of modified cholera chemical vaccine (choleragen-toxoid + O-antigens Inaba and Ogawa) were tested in 278 volunteers aged 18 years and over in comparison with those of a commercial batch of monovalent cholera vaccine (choleragen-toxoid + O-antigen Inaba). The cholera vaccine, enriched with O-antigen Ogawa, was found to be safe; vaccination with this vaccine was not accompanied by the development of systemic and local reactions whose frequency and intensity met the requirements for the reactogenic properties of commercial cholera vaccine. The immunological potency of the bivalent vaccine with respect to strain Inaba was not inferior to that of the commercial vaccine; at the same time in persons immunized with the new preparation the titers of vibriocidal antibodies to strain of serovar Inaba were five-fold higher. The conclusion on the expediency of using cholera chemical vaccine enriched with O-antigen Ogawa was made.",1991,The immunological potency of the bivalent vaccine with respect to strain Inaba was not inferior to that of the commercial vaccine; at the same time in persons immunized with the new preparation the titers of vibriocidal antibodies to strain of serovar Inaba were five-fold higher.,['278 volunteers aged 18 years and over in comparison with those of a commercial batch of monovalent cholera vaccine (choleragen-toxoid + O-antigen Inaba'],['modified cholera chemical vaccine (choleragen-toxoid + O-antigens Inaba and Ogawa'],['reactogenicity and immunological activity'],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C0008356', 'cui_str': 'Choleragen'}, {'cui': 'C0040555', 'cui_str': 'Toxoids'}, {'cui': 'C0069180', 'cui_str': 'O Antigen, Bacterial'}, {'cui': 'C0443008', 'cui_str': 'Inaba'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008354', 'cui_str': 'Vibrio cholerae Infection'}, {'cui': 'C0026384', 'cui_str': 'Molecular Vaccines'}, {'cui': 'C0008356', 'cui_str': 'Choleragen'}, {'cui': 'C0040555', 'cui_str': 'Toxoids'}, {'cui': 'C0069180', 'cui_str': 'O Antigen, Bacterial'}, {'cui': 'C0443008', 'cui_str': 'Inaba'}, {'cui': 'C0443037', 'cui_str': 'Ogawa'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",278.0,0.0544078,The immunological potency of the bivalent vaccine with respect to strain Inaba was not inferior to that of the commercial vaccine; at the same time in persons immunized with the new preparation the titers of vibriocidal antibodies to strain of serovar Inaba were five-fold higher.,"[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Sumarokov', 'Affiliation': ''}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Ivanov', 'Affiliation': ''}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Dzhaparidze', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rystsova', 'Affiliation': ''}, {'ForeName': 'Iu B', 'Initials': 'IuB', 'LastName': 'Reznikov', 'Affiliation': ''}, {'ForeName': 'L Ia', 'Initials': 'LIa', 'LastName': 'Matusevich', 'Affiliation': ''}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Nikitina', 'Affiliation': ''}, {'ForeName': 'Iu Iu', 'Initials': 'IuIu', 'LastName': 'Eliseev', 'Affiliation': ''}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Adamova', 'Affiliation': ''}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Plotnikova', 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
3311,25600568,Continuation or reintroduction of bevacizumab beyond progression to first-line therapy in metastatic colorectal cancer: final results of the randomized BEBYP trial.,"BACKGROUND


The combination of bevacizumab with fluorouracil-based chemotherapy is a standard first-line treatment option in metastatic colorectal cancer (mCRC). We studied the efficacy of continuing or reintroducing bevacizumab in combination with second-line chemotherapy after progression to bevacizumab-based first-line therapy.
PATIENTS AND METHODS


In this phase III study, patients with mCRC treated with fluoropyrimidine-based first-line chemotherapy plus bevacizumab were randomized to receive in second-line mFOLFOX-6 or FOLFIRI (depending on first-line regimen) with or without bevacizumab. The primary end point was progression-free survival. To detect a hazard ratio (HR) for progression of 0.70 with an α and β error of 0.05 and 0.20, respectively, 262 patients were required.
RESULTS


In consideration of the results of the ML18147 trial, the study was prematurely stopped. Between April 2008 and May 2012, a total of 185 patients were randomized. Bevacizumab-free interval was longer than 3 months in 43% of patients in chemotherapy alone arm and in 50% of patients in the bevacizumab arm. At a median follow-up of 45.3 months, the median progression-free survival was 5.0 months in the chemotherapy group and 6.8 months in the bevacizumab group [adjusted HR = 0.70; 95% confidence interval (CI) 0.52-0.95; stratified log-rank P = 0.010]. Subgroup analyses showed a consistent benefit in all subgroups analyzed and in particular in patients who had continued or reintroduced bevacizumab. An improved overall survival was also observed in the bevacizumab arm (adjusted HR = 0.77; 95% CI 0.56-1.06; stratified log-rank P = 0.043). Responses (RECIST 1.0) were similar in the chemotherapy and bevacizumab groups (17% and 21%; P = 0.573). Toxicity profile was consistent with previously reported data.
CONCLUSIONS


This study demonstrates that the continuation or the reintroduction of bevacizumab with second-line chemotherapy beyond first progression improves the outcome and supports the use of this strategy in the treatment of mCRC. ClinicalTrials.gov number: NCT00720512.",2015,Subgroup analyses showed a consistent benefit in all subgroups analyzed and in particular in patients who had continued or reintroduced bevacizumab.,"['patients with mCRC treated with', 'Between April 2008 and May 2012, a total of 185 patients were randomized', '262 patients were required', 'metastatic colorectal cancer (mCRC', 'metastatic colorectal cancer']","['bevacizumab with second-line chemotherapy', 'continuing or reintroducing bevacizumab in combination with second-line chemotherapy', 'fluoropyrimidine-based first-line chemotherapy plus bevacizumab', 'Bevacizumab', 'bevacizumab', 'bevacizumab with fluorouracil-based chemotherapy']","['median progression-free survival', 'overall survival', 'progression-free survival', 'Toxicity profile', 'hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",185.0,0.183397,Subgroup analyses showed a consistent benefit in all subgroups analyzed and in particular in patients who had continued or reintroduced bevacizumab.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Division of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa. Electronic address: gl.masi@tin.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Salvatore', 'Affiliation': 'Division of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Coordinating Center, AOU Careggi/Istituto Toscano Tumori, Firenze.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Division of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Division of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fornaro', 'Affiliation': 'Division of Medical Oncology, Azienda USL 2 di Lucca, Istituto Toscano Tumori, Lucca.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Division of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cupini', 'Affiliation': 'Division of Medical Oncology, Azienda USL 6 di Livorno, Istituto Toscano Tumori, Livorno.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barbara', 'Affiliation': 'Division of Medical Oncology, Azienda USL 6 di Livorno, Istituto Toscano Tumori, Livorno.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Safina', 'Affiliation': 'Division of Medical Oncology, Azienda USL 6 di Livorno, Presidio Ospedaliero di Piombino, Istituto Toscano Tumori, Piombino.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Granetto', 'Affiliation': 'Division of Medical Oncology, Ospedale S. Croce e Carle, Cuneo.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fea', 'Affiliation': 'Division of Medical Oncology, Ospedale S. Croce e Carle, Cuneo.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Antonuzzo', 'Affiliation': 'Division of Medical Oncology 1, Azienda Ospedaliero-Universitaria Careggi, Istituto Toscano Tumori, Firenze.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boni', 'Affiliation': 'Division of Medical Oncology, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Allegrini', 'Affiliation': 'Division of Medical Oncology, Azienda USL 5 di Pisa, Ospedale Felice Lotti, Istituto Toscano Tumori, Pontedera.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chiara', 'Affiliation': 'Division of Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria San Martino-Istituto Nazionale Ricerca Cancro, Genova.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Amoroso', 'Affiliation': 'Division of Medical Oncology, Ospedale della Versilia, Istituto Toscano Tumori, Lido di Camaiore.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bonetti', 'Affiliation': 'Division of Medical Oncology, AULSS 21 Legnago, Ospedale Mater Salutis, Legnago, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Division of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv012']
3312,1789034,[The reactogenicity and efficacy of a dried cell-free staphylococcal vaccine in treating chronic bronchitis].,"The data obtained in the controlled trial of the immunotherapy of chronic bronchitis (CB) patients with lyophilized acellular staphylococcal vaccine developed at the Mechnikov Research Institute for Vaccines and Sera (USSR Acad. Med. Sci.), Moscow, are presented. The patients were divided at random into two groups; of these, one group received the vaccine and the other, placebo (0.9% sodium chloride solution). The preparations were injected subcutaneously simultaneously with traditional treatment. The vaccine was well tolerated by the patients. In the blood of the patients receiving the vaccine, in contrast to those receiving placebo, a significant increase in the level of specific antibodies determined in the passive hemagglutination test and IgG was noted. When following the remote consequences of the disease for a year after the course of immunotherapy, a significant decrease in the occurrence of aggravations, an increase in the duration of remission and a decrease in the duration of sick leaves were registered. These data indicate that the immunotherapy of CB with lyophilized acellular staphylococcal vaccine is a promising method of preventing relapses.",1991,"In the blood of the patients receiving the vaccine, in contrast to those receiving placebo, a significant increase in the level of specific antibodies determined in the passive hemagglutination test and IgG was noted.","['treating chronic bronchitis', 'chronic bronchitis (CB) patients with']","['lyophilized acellular staphylococcal vaccine', 'placebo', 'vaccine and the other, placebo (0.9% sodium chloride solution', 'dried cell-free staphylococcal vaccine']","['level of specific antibodies', 'occurrence of aggravations', 'reactogenicity and efficacy', 'duration of remission', 'duration of sick leaves']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0008677', 'cui_str': 'Bronchitis, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038168', 'cui_str': 'Staphylococcal Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}]",,0.0237372,"In the blood of the patients receiving the vaccine, in contrast to those receiving placebo, a significant increase in the level of specific antibodies determined in the passive hemagglutination test and IgG was noted.","[{'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Egorova', 'Affiliation': ''}, {'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Efremova', 'Affiliation': ''}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Veshkina', 'Affiliation': ''}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Shevelev', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': ""Kuz'mina"", 'Affiliation': ''}]","Zhurnal mikrobiologii, epidemiologii i immunobiologii",[]
3313,25814651,Prognostic value of KRAS mutations in stage III colon cancer: post hoc analysis of the PETACC8 phase III trial dataset.,,2015,,['stage III colon cancer'],[],[],"[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]",[],[],,0.0361543,,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Thaler', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Gaenzer', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eisterer', 'Affiliation': ''}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': ''}, {'ForeName': 'Hellmut', 'Initials': 'H', 'LastName': 'Samonigg', 'Affiliation': ''}, {'ForeName': 'August', 'Initials': 'A', 'LastName': 'Zabernigg', 'Affiliation': ''}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Schmid', 'Affiliation': ''}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Steger', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Steinacher', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Andel', 'Affiliation': ''}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Függer', 'Affiliation': ''}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Hofbauer', 'Affiliation': ''}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Woell', 'Affiliation': ''}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Geissler', 'Affiliation': ''}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Lenauer', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Prager', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': ''}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': ''}, {'ForeName': 'Gauthier', 'Initials': 'G', 'LastName': 'Demolin', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kerger', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Deboever', 'Affiliation': ''}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Ghillebert', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Polus', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': ''}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'RezaieKalantari', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Delaunoit', 'Affiliation': ''}, {'ForeName': 'Jean Charles', 'Initials': 'JC', 'LastName': 'Goeminne', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vergauwe', 'Affiliation': ''}, {'ForeName': 'Ghislain', 'Initials': 'G', 'LastName': 'Houbiers', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Humblet', 'Affiliation': ''}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Janssens', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schrijvers', 'Affiliation': ''}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vanderstraeten', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vermorken', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Van Daele', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Forget', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Hendlisz', 'Affiliation': ''}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': ''}, {'ForeName': 'Svend Erik', 'Initials': 'SE', 'LastName': 'Nielsen', 'Affiliation': ''}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vestermark', 'Affiliation': ''}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ychou', 'Affiliation': ''}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Zawadi', 'Affiliation': ''}, {'ForeName': 'Mohamed-Ayman', 'Initials': 'MA', 'LastName': 'Zawadi', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': ''}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna-Louridi', 'Affiliation': ''}, {'ForeName': 'Louis Marie', 'Initials': 'LM', 'LastName': 'Dourthe', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ychou', 'Affiliation': ''}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Boucher', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': ''}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Desseigne', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Texereau', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Miglianico', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rougier', 'Affiliation': ''}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Fratte', 'Affiliation': ''}, {'ForeName': 'Charles-Briac', 'Initials': 'CB', 'LastName': 'Levache', 'Affiliation': ''}, {'ForeName': 'Yacine', 'Initials': 'Y', 'LastName': 'Merrouche', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': ''}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Ramee', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnier', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Viret', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cojean-Zelek', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Michel', 'Affiliation': ''}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Lecaille', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Borel', 'Affiliation': ''}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lombard-Bohas', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': ''}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Gornet', 'Affiliation': ''}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Fein', 'Affiliation': ''}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Coulon-Sfairi', 'Affiliation': ''}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': ''}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Lagasse', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Luet', 'Affiliation': ''}, {'ForeName': 'Pierre-Luc', 'Initials': 'PL', 'LastName': 'Etienne', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Gasmi', 'Affiliation': ''}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Vanoli', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aparicio', 'Affiliation': ''}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Perrier', 'Affiliation': ''}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Stremsdoerfer', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Laplaige', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Arsene', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Auby', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bedenne', 'Affiliation': ''}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Coriat', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Denis', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Geoffroy', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Piot', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Becouarn', 'Affiliation': ''}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Bordes', 'Affiliation': ''}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuis', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Fruge', 'Affiliation': ''}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Guimbaud', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': ''}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Lledo', 'Affiliation': ''}, {'ForeName': 'Iradej', 'Initials': 'I', 'LastName': 'Sobhani', 'Affiliation': ''}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Asnacios', 'Affiliation': ''}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Azzedine', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Desauw', 'Affiliation': ''}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Galais', 'Affiliation': ''}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Gargot', 'Affiliation': ''}, {'ForeName': 'You-Heng', 'Initials': 'YH', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'Abakar', 'Initials': 'A', 'LastName': 'Abakar-Mahamat', 'Affiliation': ''}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Berdah', 'Affiliation': ''}, {'ForeName': 'Sylviane', 'Initials': 'S', 'LastName': 'Catteau', 'Affiliation': ''}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Clavero-Fabri', 'Affiliation': ''}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Codoul', 'Affiliation': ''}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Legoux', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Goldfain', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Guichard', 'Affiliation': ''}, {'ForeName': 'Denis Pere', 'Initials': 'DP', 'LastName': 'Verge', 'Affiliation': ''}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Provencal', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vedrenne', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brezault-Bonnet', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Cleau', 'Affiliation': ''}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Desir', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fallik', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Gaspard', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Genet', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hartwig', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Krummel', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'MatysiakBudnik', 'Affiliation': ''}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Palascak-Juif', 'Affiliation': ''}, {'ForeName': 'Harizo', 'Initials': 'H', 'LastName': 'Randrianarivelo', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Aleba', 'Affiliation': ''}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Darut-Jouve', 'Affiliation': ''}, {'ForeName': 'Aimery', 'Initials': 'A', 'LastName': 'de Gramont', 'Affiliation': ''}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Hamon', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Wendehenne', 'Affiliation': ''}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Matzdorff', 'Affiliation': ''}, {'ForeName': 'Michael Konrad', 'Initials': 'MK', 'LastName': 'Stahl', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schepp', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burk', 'Affiliation': ''}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Geissler', 'Affiliation': ''}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Mantovani-Loeffler', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hoehler', 'Affiliation': ''}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Asperger', 'Affiliation': ''}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Kroening', 'Affiliation': ''}, {'ForeName': 'Ludwig Fischer', 'Initials': 'LF', 'LastName': 'von Weikersthal', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fuxius', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Groschek', 'Affiliation': ''}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Meiler', 'Affiliation': ''}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Trarbach', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Rauh', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Ziegenhagen', 'Affiliation': ''}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Kretzschmar', 'Affiliation': ''}, {'ForeName': 'Ullrich', 'Initials': 'U', 'LastName': 'Graeven', 'Affiliation': ''}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Nusch', 'Affiliation': ''}, {'ForeName': 'Goetz', 'Initials': 'G', 'LastName': 'von Wichert', 'Affiliation': ''}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Kleber', 'Affiliation': ''}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Vehling-Kaiser', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Baum', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schuette', 'Affiliation': ''}, {'ForeName': 'Georg Martin', 'Initials': 'GM', 'LastName': 'Haag', 'Affiliation': ''}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Holtkamp', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Reiber', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schliesser', 'Affiliation': ''}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Schmoll', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schneider-Kappus', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Abenhardt', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Henning', 'Affiliation': ''}, {'ForeName': 'Bartscht', 'Initials': 'B', 'LastName': 'Marxsen', 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'GuenterDerigs', 'Affiliation': ''}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Lambertz', 'Affiliation': ''}, {'ForeName': 'Ingulf', 'Initials': 'I', 'LastName': 'Becker-Boost', 'Affiliation': ''}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Caca', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Constantin', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Eschenburg', 'Affiliation': ''}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Gabius', 'Affiliation': ''}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hebart', 'Affiliation': ''}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Hoffmeister', 'Affiliation': ''}, {'ForeName': 'Heinz-August', 'Initials': 'HA', 'LastName': 'Horst', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kremers', 'Affiliation': ''}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Leithaeuser', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Daum', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schlegel', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Stauch', 'Affiliation': ''}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': ''}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Mini', 'Affiliation': ''}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': ''}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Boni', 'Affiliation': ''}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': ''}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Latini', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': ''}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Aprile', 'Affiliation': ''}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Barni', 'Affiliation': ''}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Mattioli', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Martoni', 'Affiliation': ''}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Passalacqua', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Nicolini', 'Affiliation': ''}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Pasquini', 'Affiliation': ''}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Rabbi', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Aitini', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ravaioli', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Biasco', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamberi', 'Affiliation': ''}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Gambi', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Verusio', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Marzola', 'Affiliation': ''}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Lelli', 'Affiliation': ''}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Boni', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cascinu', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bidoli', 'Affiliation': ''}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Vaghi', 'Affiliation': ''}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cruciani', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Costanzo', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Mini', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Petrioli', 'Affiliation': ''}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aglietta', 'Affiliation': ''}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Alabiso', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Capuzzo', 'Affiliation': ''}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': ''}, {'ForeName': 'Domenico Cristi', 'Initials': 'DC', 'LastName': 'Corsi', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': ''}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Salvagni', 'Affiliation': ''}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Chiara', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ferraù', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giuliani', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gebbia', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mantovani', 'Affiliation': ''}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Sanches', 'Affiliation': ''}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Sanches', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Mellidez', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Freire', 'Affiliation': ''}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sarmento', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Antonio Moreira', 'Initials': 'AM', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Barroso', 'Affiliation': ''}, {'ForeName': 'Jorge Espirito', 'Initials': 'JE', 'LastName': 'Santo', 'Affiliation': ''}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Guedes', 'Affiliation': ''}, {'ForeName': 'Amélia', 'Initials': 'A', 'LastName': 'Monteiro', 'Affiliation': ''}, {'ForeName': 'Anabela', 'Initials': 'A', 'LastName': 'Sa', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Furtado', 'Affiliation': ''}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ''}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Salazar', 'Affiliation': ''}, {'ForeName': 'Enrique Aranda', 'Initials': 'EA', 'LastName': 'Aguilar', 'Affiliation': ''}, {'ForeName': 'Fernando Rivera', 'Initials': 'FR', 'LastName': 'Herrero', 'Affiliation': ''}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ''}, {'ForeName': 'Javier Sastre', 'Initials': 'JS', 'LastName': 'Valera', 'Affiliation': ''}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'ValladaresAyerbes', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'FeliuBatlle', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia-Giron', 'Affiliation': ''}, {'ForeName': 'Guillermo Lopez', 'Initials': 'GL', 'LastName': 'Vivanco', 'Affiliation': ''}, {'ForeName': 'Antonia Salud', 'Initials': 'AS', 'LastName': 'Salvia', 'Affiliation': ''}, {'ForeName': 'Vicente Alonso', 'Initials': 'VA', 'LastName': 'Orduña', 'Affiliation': ''}, {'ForeName': 'Ruth Vera', 'Initials': 'RV', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gallego', 'Affiliation': ''}, {'ForeName': 'Bartomeu Massuti', 'Initials': 'BM', 'LastName': 'Sureda', 'Affiliation': ''}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Remon', 'Affiliation': ''}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Safont Aguilera', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'CireraNogueras', 'Affiliation': ''}, {'ForeName': 'BernadoQueralt', 'Initials': 'B', 'LastName': 'Merino', 'Affiliation': ''}, {'ForeName': 'Cristina Gravalos', 'Initials': 'CG', 'LastName': 'Castro', 'Affiliation': ''}, {'ForeName': 'Purificacion Martinez', 'Initials': 'PM', 'LastName': 'de Prado', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'PijaumePericay', 'Affiliation': ''}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'ConstenlaFigueiras', 'Affiliation': ''}, {'ForeName': 'InmaculadaGuasch', 'Initials': 'I', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'GomeReina', 'Affiliation': ''}, {'ForeName': 'Amelia Lopez-Ladron', 'Initials': 'AL', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Antonio Arrivi', 'Initials': 'AA', 'LastName': 'Garcia-Ramos', 'Affiliation': ''}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': ''}, {'ForeName': 'Carlos Fernandez', 'Initials': 'CF', 'LastName': 'Martos', 'Affiliation': ''}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'MarcuelloGaspar', 'Affiliation': ''}, {'ForeName': 'Ines Cabezas', 'Initials': 'IC', 'LastName': 'Montero', 'Affiliation': ''}, {'ForeName': 'Pilar Escudero', 'Initials': 'PE', 'LastName': 'Emperador', 'Affiliation': ''}, {'ForeName': 'Ana Leon', 'Initials': 'AL', 'LastName': 'Carbonero', 'Affiliation': ''}, {'ForeName': 'Manuel Gallen', 'Initials': 'MG', 'LastName': 'Castillo', 'Affiliation': ''}, {'ForeName': 'Teresa Garcia', 'Initials': 'TG', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Jose Garcia', 'Initials': 'JG', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Encarnacion Gonzalez', 'Initials': 'EG', 'LastName': 'Flores', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'GuillotMorales', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'LlanosMuñoz', 'Affiliation': ''}, {'ForeName': 'Ana López', 'Initials': 'AL', 'LastName': 'Martín', 'Affiliation': ''}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Maurel', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Camara', 'Affiliation': ''}, {'ForeName': 'Rosario Dueñas', 'Initials': 'RD', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Salgado', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'HernandezBusquier', 'Affiliation': ''}, {'ForeName': 'Teresa Checa', 'Initials': 'TC', 'LastName': 'Ruiz', 'Affiliation': ''}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'LacastaMuñoa', 'Affiliation': ''}, {'ForeName': 'MiquelNogue', 'Initials': 'M', 'LastName': 'Aliguer', 'Affiliation': ''}, {'ForeName': 'Amalia Velasco', 'Initials': 'AV', 'LastName': 'Ortiz de Taranco', 'Affiliation': ''}, {'ForeName': 'Miguel Mendez', 'Initials': 'MM', 'LastName': 'Ureña', 'Affiliation': ''}, {'ForeName': 'Ferran Losa', 'Initials': 'FL', 'LastName': 'Gaspa', 'Affiliation': ''}, {'ForeName': 'Jose Juan', 'Initials': 'JJ', 'LastName': 'Ponce', 'Affiliation': ''}, {'ForeName': 'Carlos Bosch', 'Initials': 'CB', 'LastName': 'Roig', 'Affiliation': ''}, {'ForeName': 'Pedro Valero', 'Initials': 'PV', 'LastName': 'Jimenez', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'GalanBrotons', 'Affiliation': ''}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'AlbiolRodriguez', 'Affiliation': ''}, {'ForeName': 'Jose Ales', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'Liliana Canosa', 'Initials': 'LC', 'LastName': 'Ruiz', 'Affiliation': ''}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'CentellesRuiz', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': ''}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Tahir', 'Affiliation': ''}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': ''}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': ''}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Samuel', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv070']
3314,25361992,Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial.,"BACKGROUND


To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial.
PATIENTS AND METHODS


Patients were randomly assigned to enzalutamide 160 mg/day or placebo. FACT-P was completed before randomization, at weeks 13, 17, 21, and 25, and every 12 weeks thereafter while on study treatment. Longitudinal changes in FACT-P scores from baseline to 25 weeks were analyzed using a mixed effects model for repeated measures (MMRM), with a pattern mixture model (PMM) applied as secondary analysis to address non-ignorable missing data. Cumulative distribution function (CDF) plots were generated and different methodological approaches and models for handling missing data were applied. Due to the exploratory nature of the analyses, adjustments for multiple comparisons were not made. AFFIRM is registered with ClinicalTrials.gov, number NCT00974311.
RESULTS


The intention-to-treat FACT-P population included 938 patients (enzalutamide, n = 674; placebo n = 264) with evaluable FACT-P assessments at baseline and ≥1 post-baseline assessment. After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001). In addition, significant treatment differences at week 25 favoring enzalutamide were evident for all FACT-P subscales and indices, whether analyzed by MMRM or PMM. CDF plots revealed differences favoring enzalutamide compared with placebo across the full range of possible response levels for FACT-P total and all disease- and symptom-specific subscales/indices.
CONCLUSION


In men with progressive mCRPC after docetaxel-based chemotherapy, enzalutamide is superior to placebo in health-related quality-of-life outcomes, regardless of analysis model or threshold selected for meaningful response.
CLINICAL TRIAL NUMBER


NCT00974311.",2015,"After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001).","['938 patients (enzalutamide, n = 674; placebo n = 264) with evaluable FACT-P assessments at baseline and ≥1 post-baseline assessment', 'men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial', 'Patients', 'men with progressive mCRPC after', 'men with metastatic castration-resistant prostate cancer after chemotherapy']","['placebo', 'enzalutamide or placebo', 'docetaxel-based chemotherapy, enzalutamide', 'enzalutamide 160 mg/day or placebo', 'enzalutamide']","['Cumulative distribution function (CDF) plots', 'mean FACT-P total score', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}]",264.0,0.540322,"After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, USA. Electronic address: d-cella@northwestern.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'Consulting, Quintiles, Hoofddorp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Holmstrom', 'Affiliation': 'Global Data Science, Health Economics & Outcomes Research, Astellas Pharma Global Development, Leiden, The Netherlands.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Bui', 'Affiliation': 'Health Economics & Clinical Outcomes Research, Astellas Pharma US, Inc., Northbrook, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spalding', 'Affiliation': 'Health Economics & Clinical Outcomes Research, Astellas Pharma US, Inc., Northbrook, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu510']
3315,25515657,Neutrophil-to-lymphocyte ratio as a prognostic biomarker for men with metastatic castration-resistant prostate cancer receiving first-line chemotherapy: data from two randomized phase III trials.,"BACKGROUND


The neutrophil-to-lymphocyte ratio (NLR), a marker of host inflammation, has been associated with poor outcome in several solid tumors. Here, we investigated associations of the derived NLR (dNLR) and duration of initial androgen deprivation therapy (ADT) with survival of men with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line chemotherapy.
PATIENTS AND METHODS


Data from the multinational randomized phase III studies VENICE and TAX327 included a total of 2230 men with mCRPC randomized to receive first-line chemotherapy, and were used as training and validation sets, respectively. Associations of dNLR and duration of initial ADT with overall survival (OS) were evaluated by multivariable Cox regression analysis in the training set stratified for performance status and treatment arm. The model was then tested in the validation set. Subsequently, we investigated the treatment effect of docetaxel on OS in subgroups according to dNLR and duration of initial ADT.
RESULTS


In the training set, both dNLR ≥median (2) and duration of initial ADT <median (15 months) were associated with increased risk of death [hazard ratio (HR) 1.29; 95% confidence interval (CI) 1.11-1.50, P < 0.001 and HR 1.41; 95% CI 1.21-1.64, P < 0.001, respectively] after adjustment for age, alkaline phosphatase, hemoglobin, and pain at baseline. In the validation set, dNLR remained an independent prognostic factor for OS (HR 1.43; 95% CI 1.20-1.70, P < 0.001), whereas duration of initial ADT was not (HR 1.16; 95% CI 0.97-1.37, P = 0.10). In subgroup analyses of the TAX327 study, docetaxel improved OS irrespective of dNLR and duration of initial ADT.
CONCLUSION


The dNLR was prognostic for OS in men with mCRPC receiving first-line chemotherapy in two randomized phase III trials. A high dNLR (≥2) was associated with shorter survival irrespective of the received treatment. This readily available biomarker may serve for risk stratification in future clinical trials and could be incorporated into prognostic nomograms.
CLINICAL TRIALS NUMBER


NCT00519285.",2015,The dNLR was prognostic for OS in men with mCRPC receiving first-line chemotherapy in two randomized phase III trials.,"['Data from the multinational randomized phase III studies VENICE and TAX327 included a total of 2230 men with mCRPC randomized to', 'men with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line chemotherapy', 'men with mCRPC receiving first', 'men with metastatic castration-resistant prostate cancer receiving first-line chemotherapy']","['line chemotherapy', 'receive first-line chemotherapy', 'Neutrophil-to-lymphocyte ratio', 'docetaxel', 'derived NLR (dNLR) and duration of initial androgen deprivation therapy (ADT']","['dNLR and duration of initial ADT with overall survival (OS', 'duration of initial ADT', 'alkaline phosphatase, hemoglobin, and pain', 'risk of death', 'shorter survival']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",2230.0,0.159675,The dNLR was prognostic for OS in men with mCRPC receiving first-line chemotherapy in two randomized phase III trials.,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'van Soest', 'Affiliation': 'Department of Urology. Electronic address: r.vansoest@erasmusmc.nl.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Templeton', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada; Department of Medical Oncology and Hematology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Vera-Badillo', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mercier', 'Affiliation': 'Statprocess, Port-Mort, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sonpavde', 'Affiliation': 'UAB Comprehensive Cancer Center, University of Alabama, Birmingham, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Amir', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Department of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'Depertment of Oncology, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Sydney Kimmel Comprehensive Cancer Center, The Johns Hopkins Medical Institutions, Baltimore, USA.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Department of Medical Oncology, Erasmus University Medical Center and Cancer Institute, Rotterdam, The Netherlands.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu569']
3316,25538172,Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use.,"BACKGROUND


The neutrophil-lymphocyte ratio (NLR), proposed as an indicator of cancer-related inflammation, has known prognostic value in prostate cancer. We examine its association with survival (OS) and response in patients treated with second-line chemotherapy.
METHODS


We analysed patients with metastatic castration-resistant prostate cancer (mCRPC) treated in the TROPIC trial, evaluating cabazitaxel versus mitoxantrone. Cox regression models were used to investigate the association of baseline NLR (BLNLR) with OS and the significance of a change in NLR count with treatment. Logistic regression models were used to determine the association of BLNLR counts with prostate specific antigen (PSA) and RECIST responses. The optimal NLR cut-off was established based on the concordance index of different values.
RESULTS


Data from 755, 654 and 405 patients was available for OS, PSA and RECIST response analysis respectively. Median OS was 14.0 months [95% confidence interval (CI) 13.2-14.8]. Median NLR was 2.9 (IQR: 1.9-5.1). BLNLR was associated with survival (HR 1.5, 95% CI 1.1-2.1, P = 0.011) in multivariable analysis (MVA) independently of variables included in the Halabi nomogram, treatment arm and corticosteroid use. The optimal cut-off for a dichotomous NLR was selected at 3.0 based on its higher c-index related to survival. BLNLR ≥3.0 was associated with lower PSA response (40.1% versus 59.9%; P < 0.001) and RECIST response (7.7% versus 15.6%, P = 0.022) in MVA. Conversion from high (≥3) to low (<3) NLR was associated with improved survival (HR 0.66; 95% CI 0.51-0.85; P = 0.001) and higher PSA response rates (66.4% versus 33.6%; P = 0.000). Use of corticosteroids at baseline did not modify the association between NLR and survival.
CONCLUSIONS


NLR is a valid prognostic biomarker in CRPC and is associated with survival, PSA and RECIST responses in patients treated with second-line chemotherapy. Changes in NLR counts with treatment may indicate benefit. NLR prognostic value is independent of prior use of corticosteroids.
CLINICALTRIALSGOV


NCT00417079.",2015,"BLNLR was associated with survival (HR 1.5, 95% CI 1.1-2.1, P = 0.011) in multivariable analysis (MVA) independently of variables included in the Halabi nomogram, treatment arm and corticosteroid use.","['patients treated with second-line chemotherapy', 'patients with metastatic castration-resistant prostate cancer (mCRPC) treated in the TROPIC trial, evaluating']","['cabazitaxel versus mitoxantrone', 'second-line chemotherapy']","['improved survival', 'Median NLR', 'survival, PSA and RECIST responses', 'lower PSA response', 'Baseline neutrophil-lymphocyte ratio (NLR', 'survival (OS) and response', 'Median OS', 'survival', 'PSA response rates', 'RECIST response', 'BLNLR counts with prostate specific antigen (PSA) and RECIST responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}]",,0.0945403,"BLNLR was associated with survival (HR 1.5, 95% CI 1.1-2.1, P = 0.011) in multivariable analysis (MVA) independently of variables included in the Halabi nomogram, treatment arm and corticosteroid use.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorente', 'Affiliation': 'Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton (Surrey), UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': 'Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton (Surrey), UK.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Templeton', 'Affiliation': 'Department of Medical Oncology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zafeiriou', 'Affiliation': 'Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton (Surrey), UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bianchini', 'Affiliation': 'Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton (Surrey), UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ferraldeschi', 'Affiliation': 'Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton (Surrey), UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'Department of Clinical Oncology, Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Oncology, Sanofi Oncology, Cambridge.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Su', 'Affiliation': 'Oncology, Sanofi Oncology, Cambridge.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Department of Medicine: Section of Hematology & Medical Oncology and Department of Urology, Tulane University, New Orleans, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'Prostate Cancer Targeted Therapy Group and Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton (Surrey), UK. Electronic address: johann.debono@icr.ac.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu587']
3317,32001805,Association of the genetic ancestry with resistant hypertension in the ReHOT (Resistant Hypertension Optimal Treatment) randomized study.,"Resistant hypertension (RH) is defined as uncontrolled blood pressure despite treatment with three or more antihypertensive medications, including, if tolerated, a diuretic in adequate doses. It has been widely known that race is associated with blood pressure control. However, intense debate persists as to whether this is solely explained by unadjusted socioeconomical variables or genetic variation. In this scenario, the main aim was to evaluate the association between genetic ancestry and resistant hypertension in a large sample from a multicenter trial of stage II hypertension, the ReHOT study. Samples from 1,358 patients were analyzed, of which 167 were defined as resistant hypertensive. Genetic ancestry was defined using a panel of 192 polymorphic markers. The genetic ancestry was similar in resistant (52.0% European, 36.7% African and 11.3% Amerindian) and nonresistant hypertensive patients (54.0% European, 34.4% African and 11.6% Amerindian) (p > 0.05). However, we observed a statistically suggestive association of African ancestry with resistant hypertension in brown patient group. In conclusion, increased African genetic ancestry was not associated with RH in Brazilian patients from a prospective randomized hypertension clinical trial.",2020,"The genetic ancestry was similar in resistant (52.0% European, 36.7% African and 11.3% Amerindian) and nonresistant hypertensive patients (54.0% European, 34.4% African and 11.6% Amerindian) (p > 0.05).","['1,358 patients were analyzed, of which 167 were defined as resistant hypertensive']",[],['African genetic ancestry'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]",[],"[{'cui': 'C0017399', 'cui_str': 'genetics'}]",1358.0,0.0387439,"The genetic ancestry was similar in resistant (52.0% European, 36.7% African and 11.3% Amerindian) and nonresistant hypertensive patients (54.0% European, 34.4% African and 11.6% Amerindian) (p > 0.05).","[{'ForeName': 'Carolina Tosin', 'Initials': 'CT', 'LastName': 'Bueno', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Alexandre Costa', 'Initials': 'AC', 'LastName': 'Pereira', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Hadassa Campos', 'Initials': 'HC', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Luz Marina Gómez', 'Initials': 'LMG', 'LastName': 'Gómez', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Andrea Roseli Vançan Russo', 'Initials': 'ARVR', 'LastName': 'Horimoto', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Moacyr', 'Initials': 'EM', 'LastName': 'Krieger', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Jose Eduardo', 'Initials': 'JE', 'LastName': 'Krieger', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Paulo Caleb Junior Lima', 'Initials': 'PCJL', 'LastName': 'Santos', 'Affiliation': 'Department of Pharmacology - Escola Paulista de Medicina, Universidade Federal de Sao Paulo EPM-Unifesp, São Paulo, Brazil. paulo.caleb@unifesp.br.'}]",Scientific reports,['10.1038/s41598-020-58540-3']
3318,25488686,Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomized phase III ELDA trial.,"BACKGROUND


Evidence on adjuvant chemotherapy in older women with breast cancer is poor. We tested whether weekly docetaxel is more effective than standard chemotherapy.
PATIENTS AND METHODS


We carried out a multicenter, randomized phase III study. Women aged 65-79, operated for breast cancer, with average to high risk of recurrence, were allocated 1 : 1 to CMF (cyclophosphamide 600 mg/m², methotrexate 40 mg/m², fluorouracil 600 mg/m², days 1, 8) or docetaxel (35 mg/m(2) days 1, 8, 15) every 4 weeks, for four or six cycles according to hormone receptor status. Primary end point was disease-free survival (DFS). A geriatric assessment was carried out. Quality of life (QoL) was assessed with EORTC C-30 and BR-23 questionnaires.
RESULTS


From July 2003 to April 2011, 302 patients were randomized and 299 (152 allocated CMF and 147 docetaxel) were eligible. After 70-month median follow-up, 109 DFS events were observed. Unadjusted hazard ratio (HR) of DFS for docetaxel versus CMF was 1.21 [95% confidence interval (CI) 0.83-1.76, P = 0.32]; DFS estimate at 5 years was 0.69 with CMF and 0.65 with docetaxel. HR of death was 1.34 (95% CI 0.80-2.22, P = 0.26). There was no interaction between treatment arms and geriatric scales measuring patients' ability or comorbidities. Hematological toxicity, mucositis and nausea were worse with CMF; allergy, fatigue, hair loss, onychopathy, dysgeusia, diarrhea, abdominal pain, neuropathy, cardiac and skin toxicity were worse with docetaxel. One death was attributed to CMF and two to docetaxel. Increasing age, impairment in instrumental daily living activities, number of comorbidities and docetaxel treatment were independently associated with severe nonhematological toxicity. QoL was worse with docetaxel for nausea-vomiting, appetite loss, diarrhea, body image, future perspective, treatment side-effects and hair loss items.
CONCLUSIONS


Weekly docetaxel is not more effective than standard CMF as adjuvant treatment of older women with breast cancer and worsens QoL and toxicity.
CLINICALTRIALSGOV


NCT00331097.",2015,"QoL was worse with docetaxel for nausea-vomiting, appetite loss, diarrhea, body image, future perspective, treatment side-effects and hair loss items.
","['older women with early breast cancer', 'older women with breast cancer', 'From July 2003 to April 2011, 302 patients were randomized and 299 (152 allocated CMF and 147 docetaxel) were eligible', 'Women aged 65-79, operated for breast cancer, with average to high risk of recurrence']","['CMF (cyclophosphamide 600 mg/m², methotrexate 40 mg/m², fluorouracil 600 mg/m², days 1, 8) or docetaxel', 'adjuvant chemotherapy', 'Weekly docetaxel versus CMF', 'standard CMF', 'docetaxel']","['nausea-vomiting, appetite loss, diarrhea, body image, future perspective, treatment side-effects and hair loss items', 'HR of death', 'DFS estimate', 'severe nonhematological toxicity', 'fatigue, hair loss, onychopathy, dysgeusia, diarrhea, abdominal pain, neuropathy, cardiac and skin toxicity', 'Hematological toxicity, mucositis and nausea', 'Unadjusted hazard ratio (HR) of DFS', 'Quality of life (QoL', 'disease-free survival (DFS']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",302.0,0.0666998,"QoL was worse with docetaxel for nausea-vomiting, appetite loss, diarrhea, body image, future perspective, treatment side-effects and hair loss items.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli. Electronic address: f.perrone@istitutotumori.na.it.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nuzzo', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Di Rella', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gravina', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iodice', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Labonia', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Landi', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pacilio', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rossi', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""D'Aiuto"", 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Botti', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Forestieri', 'Affiliation': 'Medical Oncology, Department of Clinical Medicine and Surgery, Università Federico II, Napoli.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lauria', 'Affiliation': 'Medical Oncology, Department of Clinical Medicine and Surgery, Università Federico II, Napoli.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Medical Oncology, Department of Clinical Medicine and Surgery, Università Federico II, Napoli.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Tinessa', 'Affiliation': 'Department of Medical Oncology, Ospedale Rummo, Benevento.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Department of Medical Oncology, Ospedale Rummo, Benevento.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gori', 'Affiliation': 'Department of Medical Oncology, Ospedale Silvestrini, Perugia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Colantuoni', 'Affiliation': 'Department of Medical Oncology, Ospedale Moscati, Avellino.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barni', 'Affiliation': ""Department of Medical Oncology, Azienda Ospedaliera 'Treviglio', Treviglio.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Riccardi', 'Affiliation': 'Department of Medical Oncology, Ospedale Cardarelli, Napoli.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'De Maio', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Montanino', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Piccirillo', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Signoriello', 'Affiliation': 'Medical Statistics, Department of Mental Health and Preventive Medicine, Seconda Università di Napoli, Napoli, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gallo', 'Affiliation': 'Medical Statistics, Department of Mental Health and Preventive Medicine, Seconda Università di Napoli, Napoli, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Matteis', 'Affiliation': 'Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale-IRCCS, Napoli.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu564']
3319,25605741,Bevacizumab continuation versus no continuation after first-line chemotherapy plus bevacizumab in patients with metastatic colorectal cancer: a randomized phase III non-inferiority trial (SAKK 41/06).,"BACKGROUND


Chemotherapy plus bevacizumab is a standard option for first-line treatment in metastatic colorectal cancer (mCRC) patients. We assessed whether no continuation is non-inferior to continuation of bevacizumab after completing first-line chemotherapy.
PATIENTS AND METHODS


In an open-label, phase III multicentre trial, patients with mCRC without disease progression after 4-6 months of standard first-line chemotherapy plus bevacizumab were randomly assigned to continuing bevacizumab at a standard dose or no treatment. CT scans were done every 6 weeks until disease progression. The primary end point was time to progression (TTP). A non-inferiority limit for hazard ratio (HR) of 0.727 was chosen to detect a difference in TTP of 6 weeks or less, with a one-sided significance level of 10% and a statistical power of 85%.
RESULTS


The intention-to-treat population comprised 262 patients: median follow-up was 36.7 months. The median TTP was 4.1 [95% confidence interval (CI) 3.1-5.4] months for bevacizumab continuation versus 2.9 (95% CI 2.8-3.8) months for no continuation; HR 0.74 (95% CI 0.58-0.96). Non-inferiority could not be demonstrated. The median overall survival was 25.4 months for bevacizumab continuation versus 23.8 months (HR 0.83; 95% CI 0.63-1.1; P = 0.2) for no continuation. Severe adverse events were uncommon in the bevacizumab continuation arm. Costs for bevacizumab continuation were estimated to be ∼30,000 USD per patient.
CONCLUSIONS


Non-inferiority could not be demonstrated for treatment holidays versus continuing bevacizumab monotheray, after 4-6 months of standard first-line chemotherapy plus bevacizumab. Based on no impact on overall survival and increased treatment costs, bevacizumab as a single agent is of no meaningful therapeutic value. More efficient treatment approaches are needed to maintain control of stabilized disease following induction therapy.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, number NCT00544700.",2015,"CONCLUSIONS


Non-inferiority could not be demonstrated for treatment holidays versus continuing bevacizumab monotheray, after 4-6 months of standard first-line chemotherapy plus bevacizumab.","['patients with metastatic colorectal cancer', 'metastatic colorectal cancer (mCRC) patients', 'patients with mCRC without disease progression after 4-6 months of standard first-line chemotherapy plus']","['Bevacizumab continuation versus no continuation after first-line chemotherapy plus bevacizumab', 'bevacizumab', 'Chemotherapy plus bevacizumab']","['median overall survival', 'Severe adverse events', 'time to progression (TTP', 'overall survival', 'median TTP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}]",,0.304987,"CONCLUSIONS


Non-inferiority could not be demonstrated for treatment holidays versus continuing bevacizumab monotheray, after 4-6 months of standard first-line chemotherapy plus bevacizumab.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Koeberle', 'Affiliation': 'Department of Oncology, Kantonsspital St Gallen, St Gallen. Electronic address: dieter.koeberle@claraspital.ch.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Betticher', 'Affiliation': 'Department of Oncology, Hôpital Fribourgeois, Fribourg.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'von Moos', 'Affiliation': 'Department of Oncology, Kantonsspital Chur, Chur.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dietrich', 'Affiliation': 'SAKK Coordinating Centre, Bern.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brauchli', 'Affiliation': 'SAKK Coordinating Centre, Bern.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Baertschi', 'Affiliation': 'SAKK Coordinating Centre, Bern.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matter', 'Affiliation': 'Institute of Pharmaceutical Medicine/ECPM, Basel.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Winterhalder', 'Affiliation': 'Department of Oncology, Kantonsspital Luzern, Luzern.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Borner', 'Affiliation': 'Department of Oncology, Spitalzentrum Biel, Biel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Anchisi', 'Affiliation': 'Department of Oncology, Hôpital de Sion, Sion.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Moosmann', 'Affiliation': 'Department of Oncology, Kantonsspital Aarau, Aarau.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kollar', 'Affiliation': 'Department of Oncology, Inselspital Bern, Bern.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Saletti', 'Affiliation': 'Department of Oncology, IOSI, Bellinzona.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roth', 'Affiliation': 'Department of Oncology, HCUG, Geneva.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frueh', 'Affiliation': 'Department of Oncology, Kantonsspital St Gallen, St Gallen.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kueng', 'Affiliation': 'Department of Oncology, Hôpital Fribourgeois, Fribourg.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Popescu', 'Affiliation': 'Department of Oncology, Hirslanden Klinik Aarau, Aarau.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schacher', 'Affiliation': 'Department of Oncology, Kantonsspital Winterthur, Winterthur.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hess', 'Affiliation': 'Department of Oncology, Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Herrmann', 'Affiliation': 'Department of Oncology, Universitätsspital Basel, Basel, Switzerland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv011']
3320,32024955,Comparative pharmacokinetics of osmotic-controlled and immediate-release Eperisone tablet formulation in healthy human subjects using a sensitive plasma LC-ESI-MS/MS method.,"To evaluate and compare the pharmacokinetic (PK) characteristics of a newly developed oral osmotically controlled drug delivery system of Eperisone 150 mg tablets with Eperisone immediate release (IR) marketed tablet brand as a reference formulation. It was a single dose, two treatment, two sequence, randomized, crossover study, involving 12 healthy human subjects. A modified, sensitive LC-ESI-MS/MS method was developed and validated as per FDA guidelines for estimation of Eperisone in plasma using a simple extraction and quick protein precipitation method. Non-compartmental pharmacokinetic model was used for PK analysis. Results were statistically compared using logarithmically transformed data, where p > 0.05 was considered as non-significant with 90% CI limit of 0.8-1.25. The bio-analytical method used for estimating drug plasma concentration was found to be simple, selective, linear, accurate and precise with 0.01 ng/ml as limit of detection. The comparative PK analysis revealed an insignificant difference in AUC 0-∞,  AUC 0-t,  V z /F, Cl/F and t 1/2λz , whereas a significant difference in C max , T max  and MTTs were found. The relative bioavailability of Eperisone osmotic tablet was 109.7%. The osmotic controlled release drug formulation was found to release Eperisone for an extended period with less inter individual fluctuation in pharmacokinetic variables.",2020,The osmotic controlled release drug formulation was found to release Eperisone for an extended period with less inter individual fluctuation in pharmacokinetic variables.,"['healthy human subjects using a sensitive plasma LC-ESI-MS/MS method', '12 healthy human subjects']",['osmotic-controlled and immediate-release Eperisone tablet formulation'],"['C max , T max  and MTTs', 'relative bioavailability of Eperisone osmotic tablet']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0043606', 'cui_str': 'eperisone'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0043606', 'cui_str': 'eperisone'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]",12.0,0.0163886,The osmotic controlled release drug formulation was found to release Eperisone for an extended period with less inter individual fluctuation in pharmacokinetic variables.,"[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.'}, {'ForeName': 'Muhammad Harris', 'Initials': 'MH', 'LastName': 'Shoaib', 'Affiliation': 'Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan. mhshoaib@uok.edu.pk.'}, {'ForeName': 'Rabia Ismail', 'Initials': 'RI', 'LastName': 'Yousuf', 'Affiliation': 'Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.'}, {'ForeName': 'Faaiza', 'Initials': 'F', 'LastName': 'Qazi', 'Affiliation': 'Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.'}, {'ForeName': 'Javeria', 'Initials': 'J', 'LastName': 'Iftikhar', 'Affiliation': 'Department of General Surgery, Hamdard College of Medicine and Dentistry, Hamdard University, Karachi, 75300, Pakistan.'}, {'ForeName': 'Farrukh Rafiq', 'Initials': 'FR', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.'}, {'ForeName': 'Muhammad Iqbal', 'Initials': 'MI', 'LastName': 'Nasiri', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.'}]",Scientific reports,['10.1038/s41598-020-58801-1']
3321,25480874,Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial.,"BACKGROUND


The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME).
PATIENTS AND METHODS


The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 × 5 Gy. Chemoradiotherapy consisted of 25 × 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival.
RESULTS


Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39).
CONCLUSION


The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete planned accrual.
REGISTRATION NUMBER


Dutch Colorectal Cancer group, CKTO 2003-16, ISRCTN36266738.",2015,The HR for disease-free survival was 0.80,"['patients from 52 hospitals', '470 enrolled patients', 'rectal cancer patients treated with', 'Patients with histologically proven stage II or III rectal adenocarcinoma', 'rectal cancer patients']","['Radiotherapy', 'observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME', 'adjuvant chemotherapy', 'Adjuvant chemotherapy', 'Chemoradiotherapy', '5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT', 'fluoropyrimidine monotherapy', 'preoperative (chemo)radiotherapy and total mesorectal excision (TME', '5-FU-based chemotherapy', 'preoperative (chemo)radiotherapy and total mesorectal excision']","['HR for disease-free survival', 'overall survival', 'overall survival, disease-free survival, and recurrence rate', 'locoregional recurrences', 'distant recurrences', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum (disorder)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",470.0,0.478762,The HR for disease-free survival was 0.80,"[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Breugom', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'van Gijn', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'E W', 'Initials': 'EW', 'LastName': 'Muller', 'Affiliation': 'Department of Internal Medicine, Slingeland Hospital, Doetinchem, The Netherlands.'}, {'ForeName': 'Å', 'Initials': 'Å', 'LastName': 'Berglund', 'Affiliation': 'Department of Radiology, Oncology and Radiation Science, Uppsala University, Uppsala.'}, {'ForeName': 'C B M', 'Initials': 'CBM', 'LastName': 'van den Broek', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Clinical Oncology, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kapiteijn', 'Affiliation': 'Department of Clinical Oncology, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'J W H', 'Initials': 'JWH', 'LastName': 'Leer', 'Affiliation': 'Department of Radiotherapy, Radboud University Medical Centre, Nijmegen.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Internal Medicine, Slingeland Hospital, Doetinchem, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Martijn', 'Affiliation': 'Department of Radiotherapy, Catharina Hospital, Eindhoven.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Nagtegaal', 'Affiliation': 'Department of Pathology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Påhlman', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'C J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Academic Medical Centre, Amsterdam.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics and Bio-informatics, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'A G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}, {'ForeName': 'H J T', 'Initials': 'HJT', 'LastName': 'Rutten', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Steup', 'Affiliation': 'Department of Surgery, HAGA Hospital, The Hague, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Radiology, Oncology and Radiation Science, Uppsala University, Uppsala; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu560']
3322,25595934,"Impact of age and medical comorbidity on adjuvant treatment outcomes for stage III colon cancer: a pooled analysis of individual patient data from four randomized, controlled trials.","BACKGROUND


Adjuvant oxaliplatin plus capecitabine or leucovorin/5-fluorouracil (LV/5-FU) (XELOX/FOLFOX) is the standard of care for stage III colon cancer (CC); however, there is disagreement regarding oxaliplatin benefit in patients aged >70. In most analyses, the impact of medical comorbidity (MC) has not been assessed. Efficacy and safety of adjuvant XELOX/FOLFOX versus LV/5-FU were compared with respect to age and MC using pooled data from four randomized, controlled trials, selected for access to patient-level MC data and including commonly endorsed and utilized regimens.
PATIENTS AND METHODS


Individual data from patients with stage III CC in NSABP C-08, XELOXA, X-ACT, and AVANT were pooled, excluding bevacizumab-treated patients. Patients were grouped by treatment, MC (low versus high), or age (<70 versus ≥70), and compared for disease-free survival (DFS), overall survival (OS), and adverse events (AEs). Multivariable Cox proportional hazards regression controlled for gender, T stage, and N stage.
RESULTS


DFS benefits were shown for XELOX/FOLFOX versus LV/5-FU regardless of age or MC, although benefits were modestly attenuated for patients aged ≥70. Hazard ratios were 0.68 (P < 0.0001) and 0.77 (P < 0.014) for <70 and ≥70 age groups; 0.69 (P < 0.0001) and 0.59 (P < 0.0001) for Charlson Comorbidity Index ≤1 and >1 groups; and 0.70 (P < 0.0001) and 0.58 (P < 0.0001) for National Cancer Institute Combined Index ≤1 and >1 groups. OS was also significantly improved in all groups. Grade 3/4 serious AE rates were comparable across cohorts and MC scores and higher in patients aged ≥70. Oxaliplatin-relevant grade 3/4 AEs, including neuropathy, were comparable across ages and MC scores.
CONCLUSIONS


Results further support consideration of XELOX or FOLFOX as standard treatment options for the adjuvant management of stage III CC in all age groups and in patients with comorbidities, consistent with those who were eligible for these clinical trials.",2015,"RESULTS


DFS benefits were shown for XELOX/FOLFOX versus LV/5-FU regardless of age or MC, although benefits were modestly attenuated for patients aged ≥70.","['stage III colon cancer (CC', 'patients aged ≥70', 'patients aged >70', 'stage III colon cancer', 'Individual data from patients with stage III CC in NSABP C-08, XELOXA, X-ACT, and AVANT were pooled, excluding bevacizumab-treated patients']","['XELOX/FOLFOX', 'Oxaliplatin', 'XELOX or FOLFOX', 'oxaliplatin plus capecitabine or leucovorin/5-fluorouracil (LV/5-FU) (XELOX/FOLFOX', 'adjuvant XELOX/FOLFOX versus LV/5-FU']","['OS', 'Hazard ratios', 'Grade 3/4 serious AE rates', 'Efficacy and safety', 'disease-free survival (DFS), overall survival (OS), and adverse events (AEs', 'Charlson Comorbidity Index']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index (assessment scale)'}]",,0.228225,"RESULTS


DFS benefits were shown for XELOX/FOLFOX versus LV/5-FU regardless of age or MC, although benefits were modestly attenuated for patients aged ≥70.","[{'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Haller', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia. Electronic address: daniel.haller@uphs.upenn.edu.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': ""O'Connell"", 'Affiliation': 'National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Cartwright', 'Affiliation': 'Department of Oncology, Florida Cancer Affiliates, Ocala, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Twelves', 'Affiliation': ""Leeds Institute of Cancer and Pathology and St James's University Hospital, Leeds, UK.""}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'McKenna', 'Affiliation': 'US Medical Affairs, Genentech, Inc., South San Francisco.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Saif', 'Affiliation': 'Tufts University School of Medicine, Boston.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'US Medical Affairs, Genentech, Inc., South San Francisco.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': 'Biostatistical Center and University of Pittsburgh Graduate School of Public Health Department of Biostatistics, Pittsburgh, USA.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Schmoll', 'Affiliation': 'University Clinic, Martin Luther University, Halle, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv003']
3323,24356622,Final results from a randomized phase 3 study of FOLFIRI {+/-} panitumumab for second-line treatment of metastatic colorectal cancer.,"BACKGROUND


The study 20050181 demonstrated significant improvements in progression-free survival (PFS), objective response, and a nonsignificant trend toward increased overall survival (OS) with panitumumab-FOLFIRI versus FOLFIRI alone for second-line wild-type (WT) KRAS metastatic colorectal cancer (mCRC). Updated long-term data from a prespecified descriptive analysis are reported.
PATIENTS AND METHODS


Patients receiving one prior mCRC treatment were randomly assigned (1:1) to panitumumab (6.0 mg/kg)-FOLFIRI versus FOLFIRI every 2 weeks. Co-primary end points (PFS and OS) were prospectively analyzed by tumor KRAS status.
RESULTS


One thousand one hundred and eighty-six patients were randomly assigned. In patients with WT KRAS tumors, panitumumab-FOLFIRI significantly improved PFS versus FOLFIRI [median 6.7 versus 4.9 months; hazard ratio (HR) 0.82 [95% confidence interval (CI) 0.69, 0.97]; P = 0.023]. A trend toward longer OS was observed (median 14.5 versus 12.5 months; HR 0.92 [95% CI 0.78, 1.10]; P = 0.37). Response rates improved from 10% to 36% (P < 0.0001). From post hoc analyses in patients receiving prior oxaliplatin-bevacizumab, panitumumab-FOLFIRI improved PFS (median 6.4 versus 3.7 months; HR 0.58 [95% CI 0.37, 0.90]; P = 0.014). PFS and OS appeared longer for worst-grade skin toxicity of 2-4, versus 0-1 or FOLFIRI. Safety results were as previously reported and consistent with the known toxicities with anti-epidermal growth factor receptor therapy.
CONCLUSIONS


These data confirm the primary efficacy and safety findings of this trial and support panitumumab-FOLFIRI as a second-line treatment of WT KRAS mCRC.",2014,A trend toward longer OS was observed (median 14.5 versus 12.5 months; HR 0.92,"['Patients receiving one prior mCRC treatment', 'One thousand one hundred and eighty-six patients', 'metastatic colorectal cancer']","['FOLFIRI ', ' panitumumab', 'panitumumab', 'oxaliplatin-bevacizumab, panitumumab-FOLFIRI']","['longer OS', 'overall survival (OS', 'worst-grade skin toxicity', 'progression-free survival (PFS), objective response', 'PFS', 'Response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",1186.0,0.138824,A trend toward longer OS was observed (median 14.5 versus 12.5 months; HR 0.92,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Department of Oncology, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': ''}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Sobrero', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hotko', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'André', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': ''}, {'ForeName': 'C J A', 'Initials': 'CJ', 'LastName': 'Punt', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Strickland', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Roman', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sidhu', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt523']
3324,22228446,Development and validation of a prediction index for hand-foot skin reaction in cancer patients receiving sorafenib.,"BACKGROUND


This study describes a repeated measures prediction index to identify patients at high risk of ≥grade 2 hand-foot skin reaction (HFSR) before each week of sorafenib therapy.
METHODS


Data from 451 patients who received a sorafenib (400 mg bid) as part of a clinical trial were reviewed (Escudier B, Eisen T, Stadler WM et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007; 356: 125-134). Generalized estimating equations were used to develop the final risk model. A risk-scoring algorithm (range 0-58) was then derived from the final model coefficients. External validation was then carried out on a new sample of 1145 patients who received sorafenib under an expanded access program.
RESULTS


Pretreatment white blood cell count, female gender, good performance status, presence of lung and liver metastases and number of affected organs were predictors for ≥grade 2 HFSR. A nonlinear association between HFSR risk and treatment duration was also identified where risk was maximized at week 5 followed by a gradual decline. Before each week of therapy, patients with risk scores>40 would be considered at high risk for developing ≥grade 2 HFSR.
CONCLUSIONS


The application and planned continued refinement of this prediction tool will be an important source of patient-specific risk information for the development of moderate to severe HFSR.",2012,"This study describes a repeated measures prediction index to identify patients at high risk of ≥grade 2 hand-foot skin reaction (HFSR) before each week of sorafenib therapy.
","['Data from 451 patients who received a', 'patients at high risk of ≥grade 2 hand-foot skin reaction (HFSR) before each week of sorafenib therapy', 'cancer patients receiving', 'advanced clear-cell renal-cell carcinoma', '1145 patients who received sorafenib under an expanded access program']","['sorafenib', 'Sorafenib']","['blood cell count, female gender, good performance status, presence of lung and liver metastases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",1145.0,0.0201289,"This study describes a repeated measures prediction index to identify patients at high risk of ≥grade 2 hand-foot skin reaction (HFSR) before each week of sorafenib therapy.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dranitsaris', 'Affiliation': 'Caduceus Information Systems Inc., Toronto. Electronic address: george.dranitsaris@gmail.com.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Vincent', 'Affiliation': 'Department of Medical Oncology, London Regional Cancer Program, London, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Global Medical Affairs and Statistics, Bayer HealthCare Pharmaceuticals, Montville.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Global Medical Affairs and Statistics, Bayer HealthCare Pharmaceuticals, Montville.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Global Medical Affairs and Statistics, Bayer HealthCare Pharmaceuticals, Montville.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr580']
3325,22241898,Association between the nuclear to cytoplasmic ratio of p27 and the efficacy of adjuvant polychemotherapy in early breast cancer.,"BACKGROUND


The purpose of this study was to evaluate the prognostic and predictive value of p27 expression in patients with early breast cancer.
PATIENTS AND METHODS


Quantitative immunofluorescence assays for p27 were done on a tissue microarray that included 823 samples from patients randomized between anthracycline-based chemotherapy and no chemotherapy. Quantification of p27 was done using the AQUA® system (HistoRx, Inc., Branford, CT). Both p27 nuclear expression and the nuclear to cytoplasmic ratio were assessed.
RESULTS


Nuclear p27 expression was not predictive for the efficacy of anthracycline-based chemotherapy [adjusted P=0.18 for disease-free survival (DFS)] nor prognostic [95% confidence interval (CI) 0.99-1.01, P=0.49]. However, p27 nuclear/cytoplasmic ratio was predictive for the efficacy of adjuvant chemotherapy (adjusted P=0.016 DFS). The adjusted hazard ratio (HR) for relapse associated with adjuvant chemotherapy was 0.56 (95% CI 0.37-0.84, P=0.005) and 1.06 (95% CI 0.76-1.47, P=0.74) for patients with high and low nuclear/cytoplasmic ratio, respectively. p27 N/C ratio was prognostic in patients treated with chemotherapy (HR for relapse or death for a 1 unit increase in p27 N/C ratio was 0.30, 95% CI 0.12-0.77) but not in the untreated arm (HR for relapse or death was 1.27, 95% CI 0.58-2.8).
CONCLUSIONS


This study did not confirm the role of p27 nuclear expression as a prognostic parameter. However, the p27 nuclear/cytoplasmic ratio was predictive in patients treated with anthracycline-based chemotherapy.",2012,"p27 N/C ratio was prognostic in patients treated with chemotherapy (HR for relapse or death for a 1 unit increase in p27 N/C ratio was 0.30, 95% CI 0.12-0.77) but not in the untreated arm (HR for relapse or death was","['patients with early breast cancer', 'Quantitative immunofluorescence assays for p27 were done on a tissue microarray that included 823 samples from patients randomized between', 'early breast cancer']","['anthracycline-based chemotherapy', 'anthracycline-based chemotherapy and no chemotherapy', 'adjuvant polychemotherapy']","['p27 nuclear/cytoplasmic ratio', 'adjusted hazard ratio (HR) for relapse', 'p27 nuclear expression and the nuclear to cytoplasmic ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0079603', 'cui_str': 'Immunofluorescence'}, {'cui': 'C0079406', 'cui_str': 'p27(rex)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2717829', 'cui_str': 'Polychemotherapy'}]","[{'cui': 'C0079406', 'cui_str': 'p27(rex)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",823.0,0.0867971,"p27 N/C ratio was prognostic in patients treated with chemotherapy (HR for relapse or death for a 1 unit increase in p27 N/C ratio was 0.30, 95% CI 0.12-0.77) but not in the untreated arm (HR for relapse or death was","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Andre', 'Affiliation': 'Department of Medical Oncology, Institute Gustave Roussy, Villejuif; INSERM Unit U981; Biomarkers and New Therapeutic Targets, Université Paris Sud, Institut Gustave Roussy, Villejuif, France. Electronic address: fandre@igr.fr.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Conforti', 'Affiliation': 'Department of Medical Oncology, Institute Gustave Roussy, Villejuif.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Moeder', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mauguen', 'Affiliation': 'Unit of Biostatistics and Epidemiology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arnedos', 'Affiliation': 'Department of Medical Oncology, Institute Gustave Roussy, Villejuif.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Berrada', 'Affiliation': 'Department of Medical Oncology, Institute Gustave Roussy, Villejuif.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Department of Medical Oncology, Institute Gustave Roussy, Villejuif.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tomasic', 'Affiliation': 'Department of Pathology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spielmann', 'Affiliation': 'Department of Medical Oncology, Institute Gustave Roussy, Villejuif.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas, MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Rimm', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Michiels', 'Affiliation': 'Unit of Biostatistics and Epidemiology; Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Bruxelles, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr569']
3326,24504441,Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study.,"BACKGROUND


In a randomized phase III study, trametinib prolonged progression-free survival and improved overall survival versus chemotherapy in patients with BRAF V600 mutation-positive melanoma.
PATIENTS AND METHODS


Patients' quality of life (QOL) was assessed at baseline and follow-up visits using the European Organisation for Research and Treatment of Cancer Core QOL questionnaire.
RESULTS


In the primary efficacy population (BRAF V600E+, no brain metastases) from baseline to weeks 6 and 12, patients' global health status scores worsened by 4-5 points with chemotherapy but improved by 2-3 points with trametinib. Rapid and substantive reductions in QOL functionality (e.g. role functioning, 8-11 points at weeks 6 and 12) and symptom exacerbation (e.g. fatigue, 4-8 points; nausea and vomiting, 5 points, both at weeks 6 and 12) were observed in chemotherapy-treated patients. In contrast, trametinib-treated patients reported small improvements or slight worsening from baseline at week 12, depending on the functional dimension and symptom. The mean symptom-scale scores for chemotherapy-treated patients increased from baseline (symptoms worsened) for seven of eight symptoms at week 6 (except insomnia) and six of eight symptoms at week 12 (except dyspnea and insomnia). In contrast, at weeks 6 and 12, the mean symptom-scale scores for trametinib decreased from baseline (symptoms improved) for pain (11-12 points), insomnia (10-12 points), and appetite loss (1-5 points), whereas those for diarrhea worsened (15-16 points). Mixed-model repeated-measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements (small to moderate) from baseline in favor of trametinib for global health; physical, role, and social functioning; fatigue; pain; insomnia; nausea and vomiting; constipation; dyspnea; and appetite at weeks 6 and/or 12. QOL results for the intent-to-treat population were consistent.
CONCLUSIONS


This first QOL assessment for a MEK inhibitor in metastatic melanoma demonstrated that trametinib was associated with less functional impairment, smaller declines in health status, and less exacerbation of symptoms versus chemotherapy.",2014,The mean symptom-scale scores for chemotherapy-treated patients increased from baseline (symptoms worsened) for seven of eight symptoms at week 6 (except insomnia) and six of eight symptoms at week 12 (except dyspnea and insomnia).,"['Patients', 'patients with BRAF V600 mutation-positive melanoma', 'BRAF V600E advanced or metastatic melanoma']","['trametinib versus chemotherapy', 'chemotherapy']","['mean symptom-scale scores', 'nausea and vomiting', 'efficacy population (BRAF V600E+, no brain metastases', 'diarrhea', 'overall survival', 'QOL functionality', 'mean symptom-scale scores for trametinib decreased from baseline (symptoms improved) for pain', 'global health status scores', 'appetite loss', 'quality of life (QOL', 'symptom exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0034380'}]",,0.150617,The mean symptom-scale scores for chemotherapy-treated patients increased from baseline (symptoms worsened) for seven of eight symptoms at week 6 (except insomnia) and six of eight symptoms at week 12 (except dyspnea and insomnia).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Amonkar', 'Affiliation': 'Global Health Outcomes, Oncology Research and Development, and Clinical Statistics, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milhem', 'Affiliation': 'Department of Internal Medicine, University of Iowa Hospital and Clinics, Iowa City, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Grotzinger', 'Affiliation': 'Global Health Outcomes, Oncology Research and Development, and Clinical Statistics, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Demidov', 'Affiliation': 'Department of Tumor Biotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'Department of Dermatology, National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wolter', 'Affiliation': 'Department of General Medical Oncology and Laboratory of Experimental Oncology, University Hospitals, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Department of Dermato-Oncology, Elbekliniken, Buxtehude.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Trefzer', 'Affiliation': 'Department of Dermatology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rutten', 'Affiliation': 'Department of Oncology, Sint-Augustinus, Wilrijk, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Steven', 'Affiliation': 'The Wellcome Trust Clinical Research Facility, The Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ullenhag', 'Affiliation': 'Department of Oncology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sherman', 'Affiliation': 'Global Health Outcomes, Oncology Research and Development, and Clinical Statistics, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Wu', 'Affiliation': 'Global Health Outcomes, Oncology Research and Development, and Clinical Statistics, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Global Health Outcomes, Oncology Research and Development, and Clinical Statistics, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Casey', 'Affiliation': 'Global Health Outcomes, Oncology Research and Development, and Clinical Statistics, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Dermatology and U 981, Institut Gustave Roussy, Villejuif-Paris-Sud, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt580']
3327,24504445,A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: results of the OMEGA study of the Dutch Breast Cancer Research Group BOOG.,"BACKGROUND


Prospective data on chemotherapy for elderly patients with metastatic breast cancer (MBC) remain scarce. We compared the efficacy and safety of first-line chemotherapy with pegylated liposomal doxorubicin (PLD) versus capecitabine in MBC patients aged ≥65 years in a multicentre, phase III trial.
PATIENTS AND METHODS


Patients were randomized to six cycles of PLD (45 mg/m(2) every 4 weeks) or eight cycles of capecitabine (1000 mg/m(2) twice daily, day 1-14 every 3 weeks).
RESULTS


The study enrolled 78 of the planned 154 patients and was closed prematurely due to slow accrual and supply problems of PLD. Many included patients were aged ≥75 years (54%) and vulnerable (≥1 geriatric condition: 71%). The median dose intensity was 85% for PLD and 84% for capecitabine, respectively. In both arms, the majority of patients completed at least 12 weeks of treatment (PLD 73%; capecitabine 74%). After a median follow-up of 39 months, 77 patients had progressed and 62 patients had died of MBC. Median progression-free survival was 5.6 versus 7.7 months (P = 0.11) for PLD and capecitabine, respectively. Median overall survival was 13.8 months for PLD and 16.8 months for capecitabine (P = 0.59). Both treatments were feasible, grade 3 toxicities consisting of fatigue (both arms: 13%), hand-foot syndrome (PLD: 10%; capecitabine: 16%), stomatitis (PLD: 10%; capecitabine: 3%), exanthema (PLD: 5%) and diarrhoea (PLD: 3%; capecitabine: 5%). Only 1 of 10 patients aged ≥80 years completed chemotherapy, while 3 and 6 patients discontinued treatment due to toxicity or progressive disease, respectively.
CONCLUSION


Both PLD and capecitabine demonstrated comparable efficacy and acceptable tolerance as first-line single-agent chemotherapy in elderly patients with MBC, even in vulnerable patients or patients aged ≥75 years. However, patients aged ≥80 years were unlikely to complete chemotherapy successfully.
CLINICAL TRIAL NUMBERS


EudraCT 2006-002046-10; ISRCTN 11114726; CKTO 2006-09; BOOG 2006-02.",2014,"Both treatments were feasible, grade 3 toxicities consisting of fatigue (both arms: 13%), hand-foot syndrome (PLD: 10%; capecitabine: 16%), stomatitis (PLD: 10%; capecitabine: 3%), exanthema (PLD: 5%) and diarrhoea (PLD: 3%; capecitabine: 5%).","['10 patients aged ≥80 years completed chemotherapy, while 3 and 6 patients discontinued treatment due to toxicity or progressive disease, respectively', 'The study enrolled 78 of the planned 154 patients and was closed prematurely due to slow accrual and supply problems of PLD', 'Patients', 'elderly patients with MBC, even in vulnerable patients or patients aged ≥75 years', 'MBC patients aged ≥65 years in a multicentre, phase III trial', 'Many included patients were aged ≥75 years (54%) and vulnerable (≥1 geriatric condition: 71', 'elderly patients with metastatic breast cancer (MBC', 'elderly patients with metastatic breast cancer', 'patients aged ≥80 years']","['capecitabine', 'PLD', 'chemotherapy', 'first-line chemotherapy with pegylated liposomal doxorubicin (PLD', 'pegylated liposomal doxorubicin with capecitabine']","['diarrhoea', 'efficacy and safety', 'died of MBC', 'Median overall survival', 'median dose intensity', 'Median progression-free survival', 'feasible, grade 3 toxicities consisting of fatigue', 'efficacy and acceptable tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",78.0,0.100112,"Both treatments were feasible, grade 3 toxicities consisting of fatigue (both arms: 13%), hand-foot syndrome (PLD: 10%; capecitabine: 16%), stomatitis (PLD: 10%; capecitabine: 3%), exanthema (PLD: 5%) and diarrhoea (PLD: 3%; capecitabine: 5%).","[{'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Smorenburg', 'Affiliation': 'Department of Internal Medicine, Medical Center Alkmaar, Alkmaar. Electronic address: c.smorenburg@nki.nl.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'de Groot', 'Affiliation': 'Comprehensive Cancer Center the Netherlands, Amsterdam.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'van Leeuwen-Stok', 'Affiliation': 'BOOG Study Center, Dutch Breast Cancer Research Group BOOG, Amsterdam.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Hamaker', 'Affiliation': 'Department of Geriatric Medicine, Diakonessenhuis, Utrecht.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Wymenga', 'Affiliation': 'Department of Internal Medicine, Medisch Spectrum Twente, Enschede.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'de Graaf', 'Affiliation': 'Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'de Jongh', 'Affiliation': 'Department of Internal Medicine, Ikazia Hospital, Rotterdam.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Braun', 'Affiliation': 'Department of Internal Medicine, Vlietland Hospital, Schiedam.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Los', 'Affiliation': 'Department of Internal Medicine, St. Antonius Hospital, Nieuwegein.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maartense', 'Affiliation': 'Department of Internal Medicine, Reinier de Graaf Hospital, Delft.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Biometrics Department, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'J W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Seynaeve', 'Affiliation': 'Department of Medical Oncology, Erasmus Medical Center-Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt588']
3328,24510314,Hepatic intra-arterial versus intravenous fotemustine in patients with liver metastases from uveal melanoma (EORTC 18021): a multicentric randomized trial.,"BACKGROUND


In uveal melanoma (UM) with metastatic disease limited to the liver, the effect of an intrahepatic treatment on survival is unknown. We investigated prospectively the efficacy and toxicity of hepatic intra-arterial (HIA) versus systemic (IV) fotemustine in patients with liver metastases from UM.
PATIENTS AND METHODS


Patients were randomly assigned to receive either IV or HIA fotemustine at 100 mg/m(2) on days 1, 8, 15 (and 22 in HIA arm only) as induction, and after a 5-week rest period every 3 weeks as maintenance. Primary end point was overall survival (OS). Response rate (RR), progression-free survival (PFS) and safety were secondary end points.
RESULTS


Accrual was stopped after randomization of 171 patients based on the results of a futility OS analysis. A total of 155 patients died and 16 were still alive [median follow-up 1.6 years (range 0.25-6 years)]. HIA did not improve OS (median 14.6 months) when compared with the IV arm (median 13.8 months), hazard ratio (HR) 1.09; 95% confidence interval (CI) 0.79-1.50, log-rank P = 0.59. However, there was a significant benefit on PFS for HIA compared with IV with a median of 4.5 versus 3.5 months, respectively (HR 0.62; 95% CI 0.45-0.84, log-rank P = 0.002). The 1-year PFS rate was 24% in the HIA arm versus 8% in the IV arm. An improved RR was seen in the HIA (10.5%) compared with IV treatment (2.4%). In the IV arm, the most frequent grade ≥3 toxicity was thrombocytopenia (42.1%) and neutropenia (62.6%), compared with 21.2% and 28.7% in the HIA arm. The main grade ≥3 toxicity related to HIA was catheter complications (12%) and liver toxicity (4.5%) apart from two toxic deaths.
CONCLUSION


HIA treatment with fotemustine did not translate into an improved OS compared with IV treatment, despite better RR and PFS. Intrahepatic treatment should still be considered as experimental.
EUDRACT NUMBER AND CLINICALTRIALSGOV IDENTIFIER


2004-002245-12 and NCT00110123.",2014,"In the IV arm, the most frequent grade ≥3 toxicity was thrombocytopenia (42.1%) and neutropenia (62.6%), compared with 21.2% and 28.7% in the HIA arm.","['Patients', 'patients with liver metastases from uveal melanoma (EORTC 18021', 'patients with liver metastases from UM', '155 patients died and 16 were still alive [median follow-up 1.6 years (range 0.25-6 years']","['IV or HIA fotemustine', 'Hepatic intra-arterial versus intravenous fotemustine', 'hepatic intra-arterial (HIA) versus systemic (IV) fotemustine']","['1-year PFS rate', 'catheter complications', 'thrombocytopenia', 'overall survival (OS', 'RR', 'neutropenia', 'liver toxicity', 'PFS', 'OS', 'Response rate (RR), progression-free survival (PFS) and safety', 'efficacy and toxicity', 'hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220633', 'cui_str': 'Uveal melanoma'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0060696', 'cui_str': 'fotemustine'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0274317', 'cui_str': 'Complication of catheter (disorder)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.19189,"In the IV arm, the most frequent grade ≥3 toxicity was thrombocytopenia (42.1%) and neutropenia (62.6%), compared with 21.2% and 28.7% in the HIA arm.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leyvraz', 'Affiliation': 'Oncology Department, University Hospital, Lausanne, Switzerland. Electronic address: serge.leyvraz@chuv.ch.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Piperno-Neumann', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Baurain', 'Affiliation': 'Centre du Cancer, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zdzienicki', 'Affiliation': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': 'Clatterbridge Centre for Oncology, Wirral, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scheulen', 'Affiliation': 'West German Cancer Center, University of Essen Medical School, Essen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Jouary', 'Affiliation': 'University Hospital Bordeaux Saint André, Bordeaux.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Negrier', 'Affiliation': 'Léon-Bérard Cancer Centre, Lyon, France.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kaempgen', 'Affiliation': 'Universitätsklinik Erlangen, Erlangen, Germany.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Durando', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen.'}, {'ForeName': 'R Karra', 'Initials': 'RK', 'LastName': 'Gurunath', 'Affiliation': 'EORTC Headquarters, Brussels.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Department of Hematology and Medical Oncology, Charité, CBF, Berlin, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt585']
3329,25355722,"Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA.","BACKGROUND


We characterized the incidence of central nervous system (CNS) metastases after treatment with trastuzumab emtansine (T-DM1) versus capecitabine-lapatinib (XL), and treatment efficacy among patients with pre-existing CNS metastases in the phase III EMILIA study.
PATIENTS AND METHODS


In EMILIA, patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer previously treated with trastuzumab and a taxane were randomized to T-DM1 or XL until disease progression. Patients with treated, asymptomatic CNS metastases at baseline and patients developing postbaseline CNS metastases were identified retrospectively by independent review; exploratory analyses were carried out.
RESULTS


Among 991 randomized patients (T-DM1 = 495; XL = 496), 95 (T-DM1 = 45; XL = 50) had CNS metastases at baseline. CNS progression occurred in 9 of 450 (2.0%) and 3 of 446 (0.7%) patients without CNS metastases at baseline in the T-DM1 and XL arms, respectively, and in 10 of 45 (22.2%) and 8 of 50 (16.0%) patients with CNS metastases at baseline. Among patients with CNS metastases at baseline, a significant improvement in overall survival (OS) was observed in the T-DM1 arm compared with the XL arm [hazard ratio (HR) = 0.38; P = 0.008; median, 26.8 versus 12.9 months]. Progression-free survival by independent review was similar in the two treatment arms (HR = 1.00; P = 1.000; median, 5.9 versus 5.7 months). Multivariate analyses demonstrated similar results. Grade ≥3 adverse events were reported in 48.8% and 63.3% of patients with CNS metastases at baseline administered T-DM1 and XL, respectively; no new safety signals were observed.
CONCLUSION


In this retrospective, exploratory analysis, the rate of CNS progression in patients with HER2-positive advanced breast cancer was similar for T-DM1 and for XL, and higher overall in patients with CNS metastases at baseline compared with those without CNS metastases at baseline. In patients with treated, asymptomatic CNS metastases at baseline, T-DM1 was associated with significantly improved OS compared with XL.",2015,"Progression-free survival by independent review was similar in the two treatment arms (HR = 1.00; P = 1.000; median, 5.9 versus 5.7 months).","['patients with HER2-positive metastatic breast cancer and central nervous system metastases', 'patients with HER2-positive advanced breast cancer', 'Patients with treated, asymptomatic CNS metastases at baseline and patients developing postbaseline CNS metastases', 'patients with pre-existing CNS metastases in the phase III EMILIA study', 'patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer previously treated with', '991 randomized patients (T-DM1 = 495; XL = 496']","['Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine', 'trastuzumab emtansine (T-DM1) versus capecitabine-lapatinib (XL', 'trastuzumab and a taxane']","['CNS metastases', 'Progression-free survival', 'overall survival (OS', 'Grade ≥3 adverse events', 'rate of CNS progression', 'CNS progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}]","[{'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",991.0,0.13254,"Progression-free survival by independent review was similar in the two treatment arms (HR = 1.00; P = 1.000; median, 5.9 versus 5.7 months).","[{'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston. Electronic address: ikrop@partners.org.'}, {'ForeName': 'N U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Blackwell', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guardino', 'Affiliation': 'Product Development, Oncology, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Medical Oncology and Breast Centre, Cantonal Hospital, St Gallen, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Product Development, Oncology, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Samant', 'Affiliation': 'Biostatistics, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Welslau', 'Affiliation': 'Hematology, Medical Office, Aschaffenburg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu486']
3330,22357257,A randomised trial of primary tamoxifen versus mastectomy plus adjuvant tamoxifen in fit elderly women with invasive breast carcinoma of high oestrogen receptor content: long-term results at 20 years of follow-up.,"BACKGROUND


Long-term analysis of a randomised trial in Nottingham comparing tamoxifen versus surgery as initial treatment demonstrated that in oestrogen receptor (ER)-unselected cases, surgery achieved better local control, with no difference in overall survival. It was suggested that for patients with ER-rich tumours, local control and survival may be comparable. We now present long-term follow-up of a randomised trial designed to address this clinical scenario.
PATIENTS AND METHODS


One hundred and fifty three fit elderly (≥70 years) women with clinically node-negative primary invasive breast carcinoma <5 cm of high ER content [histochemical (H) score ≥100] were randomised 2:1 to primary tamoxifen (Tam) (N = 100) or mastectomy with adjuvant tamoxifen (Mx + Tam) (N = 53).
RESULTS


With median follow-up of 78 months, there was no statistically significant difference in 10-year rates of regional recurrence (9.0% versus 7.5%), metastasis (8.0% versus 13.2%), breast cancer-specific survival (89.0% versus 86.8%) or overall survival (64.0% versus 66.0%) between Tam and Mx + Tam; however, local control was inferior with Tam (local failure rates 43.0% versus 1.9%; P < 0.001).
CONCLUSION


Irrespective of the degree of ER positivity, surgery achieved better local control. However, there was excellent and similar survival in both groups. Tam could be considered in those who are 'frail', refuse or prefer not to initially undergo surgery.",2012,"; however, local control was inferior with Tam (local failure rates 43.0% versus 1.9%; P < 0.001).
","['One hundred and fifty three fit elderly (≥70 years) women with clinically node-negative primary invasive breast carcinoma <5 cm of high ER content [histochemical (H) score ≥100', 'fit elderly women with invasive breast carcinoma of high oestrogen receptor content']","['primary tamoxifen (Tam) (N = 100) or mastectomy with adjuvant tamoxifen (Mx + Tam', 'mastectomy plus adjuvant tamoxifen', 'primary tamoxifen', 'tamoxifen']","['10-year rates of regional recurrence', 'similar survival', 'overall survival', 'metastasis', 'breast cancer-specific survival']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",153.0,0.390846,"; however, local control was inferior with Tam (local failure rates 43.0% versus 1.9%; P < 0.001).
","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Johnston', 'Affiliation': 'Divisions of Breast Surgery.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Kenny', 'Affiliation': 'Divisions of Breast Surgery.'}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Syed', 'Affiliation': 'Divisions of Breast Surgery.'}, {'ForeName': 'J F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'Divisions of Breast Surgery.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Pinder', 'Affiliation': 'Pathology, University of Nottingham, Nottingham.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Winterbottom', 'Affiliation': 'Nottingham Breast Institute, Nottingham University Hospitals, Nottingham, UK.'}, {'ForeName': 'I O', 'Initials': 'IO', 'LastName': 'Ellis', 'Affiliation': 'Pathology, University of Nottingham, Nottingham.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Blamey', 'Affiliation': 'Divisions of Breast Surgery.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Cheung', 'Affiliation': 'Divisions of Breast Surgery. Electronic address: kl.cheung@nottingham.ac.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr630']
3331,24401928,Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER2-positive metastatic breast cancer.,"BACKGROUND


Nonpegylated liposomal doxorubicin liposomal doxorubicin, (Myocet™; Sopherion Therapeutics, Inc Canada, and Cephalon, Europe) (NPLD; Myocet(®)) in combination with trastuzumabHerceptin(®) (Hoffmann-La Roche) has shown promising activity and cardiac safety. We conducted a randomized phase III trial of first-line NPLD plus trastuzumab and paclitaxel (Pharmachemie B.V.) (MTP) versus trastuzumab plus paclitaxel (TP) in patients with human epidermal growth factor 2 receptor (HER2)-positive metastatic breast cancer.
PATIENTS AND METHODS


Patients were randomly assigned to NPLD (M, 50 mg/m(2) every 3 weeks for six cycles), trastuzumab (T, 4 mg/kg loading dose followed by 2 mg/kg weekly), and paclitaxel (P, 80 mg/m(2) weekly) or T + P at the same doses until progression or toxicity. The primary efficacy outcome was progression-free survival (PFS).
RESULTS


One hundred and eighty-one patients were allocated to receive MTP, and 183 to TP. Median PFS was 16.1 and 14.5 months with MTP and TP, respectively [hazard ratio (HR) 0.84; two-sided P = 0.174]. In patients with estrogen receptor (ER)- and progesterone receptor (PR)-negative tumors, PFS was 20.7 and 14.0 months, respectively [HR 0.68; 95% confidence interval (CI) 0.47-0.99]. Median overall survival (OS) was 33.6 and 28.9 months with MTP and TP, respectively (HR 0.79; two-sided P = 0.083). In ER- and PR-negative tumors, OS was 38.2 and 27.9 months, respectively (HR 0.63; 95% CI 0.42-0.93). The frequency of adverse events was higher with MTP, but there was no significant difference in cardiac toxicity between treatment arms.
CONCLUSION(S)


The trial failed to demonstrate a significant clinical improvement with the addition of M to TP regimen. The clinical benefit observed in an exploratory analysis in the ER- and PR-negative population deserves consideration for further clinical trials.
CLINICAL TRIAL NUMBER


NCT00294996.",2014,"The frequency of adverse events was higher with MTP, but there was no significant difference in cardiac toxicity between treatment arms.
","['One hundred and eighty-one patients', 'Patients', 'HER2-positive metastatic breast cancer', 'patients with human epidermal growth factor 2 receptor (HER2)-positive metastatic breast cancer']","['MTP', 'NPLD plus trastuzumab and paclitaxel (Pharmachemie B.V.) (MTP) versus trastuzumab plus paclitaxel (TP', 'trastuzumab (T, 4 mg/kg loading dose followed by 2 mg/kg weekly), and paclitaxel', 'trastuzumabHerceptin(®) (Hoffmann-La Roche', 'NPLD', 'trastuzumab and paclitaxel', 'nonpegylated liposomal doxorubicin', 'liposomal doxorubicin liposomal doxorubicin, ']","['cardiac toxicity', 'Median PFS', 'frequency of adverse events', 'Median overall survival (OS', 'progression-free survival (PFS']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1509244', 'cui_str': 'nepidermin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0065610', 'cui_str': 'maltose tetrapalmitate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0876994', 'cui_str': 'Cardiac Toxicity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",181.0,0.115381,"The frequency of adverse events was higher with MTP, but there was no significant difference in cardiac toxicity between treatment arms.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, USA; SOLTI Breast Cancer Research Group, Barcelona, Spain. Electronic address: baselgaj@mskcc.org.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manikhas', 'Affiliation': 'City Clinical Oncology Dispensary, St. Petersburg, Russia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Medical Oncology, Vall d'Hebron University Hospital, Barcelona.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Llombart', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Medical Oncology, Arnau de Vilanova Hospital, Valencia, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Roman', 'Affiliation': 'Leningrad Regional Oncology Dispensary, St. Petersburg.'}, {'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Semiglazov', 'Affiliation': 'Department of Tumor of Reproductive System, N.N. Petrov Research Institute of Oncology, St. Petersburg.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Byakhov', 'Affiliation': 'Central Clinical Hospital No. 2 Named After N.A. Semashko, Moskow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lokanatha', 'Affiliation': 'Department of Medical Oncology, Kidway Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Forenza', 'Affiliation': 'Sopherion Therapeutics, East Brunswick.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Goldfarb', 'Affiliation': 'Sopherion Therapeutics, East Brunswick.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Matera', 'Affiliation': 'Sopherion Therapeutics, East Brunswick.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Azarnia', 'Affiliation': 'Oncology Statistics LLC, Laguna Niguel, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rozencweig', 'Affiliation': 'Sopherion Therapeutics, East Brunswick.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt543']
3332,22377563,"A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy.","BACKGROUND


Recurrent platinum-resistant ovarian cancer usually has a poor outcome with conventional chemotherapeutic therapy and new treatment modalities are warranted. This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting.
MATERIAL AND METHODS


The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously).
RESULTS


Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response + partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9-8.1] months; arm 2: 2.9 [2.9-5.1] months) and the median overall survival (arm 1: 13.6 [7.0-23.2] months; arm 2: 13.7 [8.4-25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups.
CONCLUSIONS


Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer.",2012,The median progression-free survival (arm 1: 4.8 [2.9-8.1] months; arm 2: 2.9 [2.9-5.1] months) and the median overall survival (arm 1: 13.6 [7.0-23.2] months; arm 2: 13.7 [8.4-25.6] months) revealed no significant difference.,"['36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients', '73 patients enrolled', 'patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies', 'platinum-resistant ovarian cancer']","['sunitinib', 'multitargeted receptor tyrosine kinase inhibitor monotherapy', 'conventional chemotherapeutic therapy']","['median overall survival', 'median progression-free survival', 'objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib', 'fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities', 'tolerability, toxicity and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",73.0,0.085582,The median progression-free survival (arm 1: 4.8 [2.9-8.1] months; arm 2: 2.9 [2.9-5.1] months) and the median overall survival (arm 1: 13.6 [7.0-23.2] months; arm 2: 13.7 [8.4-25.6] months) revealed no significant difference.,"[{'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Baumann', 'Affiliation': 'Department of Gynaecology, University of Marburg, Marburg. Electronic address: baumannk@med.uni-marburg.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynaecology and Gynaecological Oncology, HSK Wiesbaden and Kliniken Essen Mitte, Essen.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Department of Gynaecology and Obstetrics, Evangelic Hospital, Duesseldorf.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rau', 'Affiliation': 'Coordinating Centre for Clinical Trials, University of Marburg, Marburg.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wimberger', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Duisburg-Essen, Essen.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynaecology, Charité, Berlin.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kurzeder', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Ulm, Ulm.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Kiel, Kiel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Freiburg, Freiburg.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Dresden, Dresden.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Hanker', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Frankfurt am Main, Frankfurt am Main.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': 'Department of Gynaecology and Obstetrics, Medical School Hannover, Hannover.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Richter', 'Affiliation': 'Department of Gynaecology and Obstetrics, Elbland Hospital, Radebeul.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wollschlaeger', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Magdeburg, Magdeburg.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dewitz', 'Affiliation': 'Department of Gynaecology and Obstetrics, Hospital of Gifhorn, Gifhorn.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bauerschlag', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Medical Center Aachen RWTH, Aachen, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Wagner', 'Affiliation': 'Department of Gynaecology, University of Marburg, Marburg.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds003']
3333,22734013,Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone.,"BACKGROUND


Malignant ascites (MA) is associated with poor prognosis and limited palliative therapeutic options. Therefore, quality of life (QoL) assessment is of particular importance to demonstrate new treatment value. Following the demonstration of the superiority of catumaxomab and paracentesis over paracentesis on puncture-free survival, this analysis aimed at comparing deterioration in QoL between both the treatment options.
PATIENTS AND METHODS


In a randomised, multicentre, phase II/III study of patients with MA due to epithelial cell adhesion molecule (EpCAM) positive cancer, the QoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) questionnaire at screening, 1, 3 and 7 months after treatment and in the case of re-puncture on the day of paracentesis. Time to first deterioration in QoL was defined as a decrease in the QoL score of at least five points and compared between the catumaxomab (n=160) and control (n=85) groups using the log-rank test and Cox proportional hazards models adjusted for baseline score, country and primary tumour type.
RESULTS


Deterioration in QoL scores appeared more rapidly in the control than in the catumaxomab group (median 19-26 days versus 47-49 days). The difference in time to deterioration in QoL between the groups was statistically significant for all scores (P<0.01). The hazard ratios ranged from 0.08 to 0.24 (P<0.01).
CONCLUSIONS


Treatment with catumaxomab delayed deterioration in QoL in patients with MA. Compared with paracentesis alone, catumaxomab enabled patients to benefit from better QoL for a prolonged survival period.",2012,The difference in time to deterioration in QoL between the groups was statistically significant for all scores (P<0.01).,"['patients with MA', 'patients with MA due to epithelial cell adhesion molecule (EpCAM) positive cancer, the QoL', 'patients with malignant ascites']","['catumaxomab and paracentesis over paracentesis', 'catumaxomab', 'paracentesis plus catumaxomab with paracentesis alone']","['time to deterioration in QoL', 'QoL score', 'Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) questionnaire', 'QoL scores', 'quality of life (QoL', 'quality of life (QoL) assessment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1704265', 'cui_str': 'GA733 Tumor-Associated Antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220656', 'cui_str': 'Malignant ascites (disorder)'}]","[{'cui': 'C1831854', 'cui_str': 'catumaxomab'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0353266,The difference in time to deterioration in QoL between the groups was statistically significant for all scores (P<0.01).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wimberger', 'Affiliation': 'Gynaecology and Obstetrics Clinic, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gilet', 'Affiliation': 'Mapi Consultancy, Lyon, France. Electronic address: hgilet@mapigroup.com.'}, {'ForeName': 'A-K', 'Initials': 'AK', 'LastName': 'Gonschior', 'Affiliation': 'Pricing, Reimbursement and Market Access, Fresenius Biotech GmbH, München.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Heiss', 'Affiliation': 'Department of Surgery, Cologne-Merheim Medical Center, Köln.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': '1st Medical Clinic and Policlinic, Johannes-Gutenberg University, Mainz.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Oskay-Oezcelik', 'Affiliation': 'Quality of Life Working Group of the North-Eastern German Society of Gynecological Oncology (NOGGO), Berlin.'}, {'ForeName': 'S-E', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Department of Hematology and Oncology, Krankenhaus Nordwest, Frankfurt.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': 'Department for Obstetrics and Gynecology, Technical University of Munich, München.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schmittel', 'Affiliation': 'Department of Hematology, Oncology and Transfusion Medicine, Charité University Hospital Berlin, Berlin.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schulze', 'Affiliation': 'Medical Affairs, Fresenius Biotech GmbH, München, Germany.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Parsons', 'Affiliation': 'Department of Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds178']
3334,25096607,"Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and quality of life.","BACKGROUND


Exercise has been reported to decrease cancer-related fatigue and to increase quality of life (QoL) in various breast cancer (BC) populations. However, studies investigating exercise during radiotherapy or resistance training are scarce. We conducted a randomized, controlled trial (BEST study) to assess the efficacy of 12-week resistance training on fatigue beyond possible psychosocial effects of a group-based intervention.
PATIENTS AND METHODS


One hundred sixty patients with BC stage 0-III were randomly assigned to a 12-week progressive resistance training (2 times/week) or a 12-week relaxation control (RC, 2 times/week). Both interventions were group-based. The primary end point fatigue was assessed with a 20-item multidimensional questionnaire, QoL with EORTC questionnaires. Statistical analyses were based on analysis of covariance models for the individual changes from baseline to week 13.
RESULTS


Adherence to the intervention program as well as the completion rate (97%) for the primary outcome variable fatigue was high. In intention-to-treat analyses for the N = 155 patients, significant between-group mean differences (MD) favoring the exercise group (EX) were observed for general fatigue (P = 0.044), especially for the subscale physical fatigue [MD = -0.8; 95% confidence interval -1.5 to -0.2, P = 0.013], but not for affective (P = 0.91) or cognitive fatigue (P = 0.65). For QoL, significantly larger improvements regarding the role function (P = 0.035) and pain (P = 0.040) were noted among exercisers compared with RCs. Future perspective improved significantly stronger in the RC group compared with the EX group (P = 0.047).
CONCLUSIONS


The 12-week resistance training program was a safe, feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy. As exercise was compared with another group-based intervention, results indicate that resistance training effects on fatigue and QoL go beyond psychosocial benefits, and that the clinically relevant overall benefit of resistance exercise compared with usual care can be assumed to be higher.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01468766.",2014,"The 12-week resistance training program was a safe, feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy.","['breast cancer patients receiving', 'One hundred sixty patients with BC stage 0-III']","['resistance training program', 'EX', 'resistance exercise', 'adjuvant radiotherapy', 'progressive resistance training', 'resistance training']","['fatigue and QoL go beyond psychosocial benefits', 'subscale physical fatigue', '20-item multidimensional questionnaire, QoL with EORTC questionnaires', 'general fatigue', 'pain', 'fatigue beyond possible psychosocial effects', 'cancer-related fatigue and quality of life', 'cancer-related fatigue and components of QoL', 'cognitive fatigue', 'completion rate', 'quality of life (QoL', 'role function']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'function'}]",160.0,0.068309,"The 12-week resistance training program was a safe, feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Steindorf', 'Affiliation': 'Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg. Electronic address: k.steindorf@dkfz.de.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Schmidt', 'Affiliation': 'Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Klassen', 'Affiliation': 'Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Ulrich', 'Affiliation': 'Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Oelmann', 'Affiliation': 'Department of Radiooncology, University of Heidelberg Medical Center, Heidelberg.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Habermann', 'Affiliation': 'Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beckhove', 'Affiliation': 'Division of Translational Immunology, German Cancer Research Center (DKFZ), Heidelberg.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': 'Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiooncology, University of Heidelberg Medical Center, Heidelberg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg; Division of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Potthoff', 'Affiliation': 'Department of Radiooncology, University of Heidelberg Medical Center, Heidelberg.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu374']
3335,25122693,"Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer: a randomized, noncomparative phase II study.","BACKGROUND


In T3 rectal cancer (RC), preoperative chemoradiotherapy [5-fluorouracil (5-FU-RT)] reduces local recurrences, but does not affect overall survival. New therapeutic options are still necessary to improve clinical outcomes.
PATIENTS AND METHODS


This randomized, noncomparative, open-label, multicenter, two arms, phase II study was conducted in MRI-defined locally advanced T3 resectable RC. In arm A, patients received 12-week bevacizumab plus 5-FU, leucovorin and oxaliplatin (Folfox-4) followed with bevacizumab-5-FU-RT before total mesorectal excision (TME). In arm B, patients received only bevacizumab-5-FU-RT before TME. Primary end point was pathological complete response (pCR) rate.
RESULTS


Forty-six patients were randomized in arm A and 45 patients in arm B. In arm A, the rate of pCR was 23.8% [95% confidence interval (CI) 12.1% to 39.5%] statistically superior to the defined standard rate of 10%, P = 0.015. In arm B, the rate of pCR of 11.4% (95% CI 3.8% to 24.6%) was not different from 10%, P = 0.906. No death occurred during the study period, from the start until 8 weeks following surgery. Postoperative fistulas were reported for 16 patients (7 in arm A and 9 in arm B).
CONCLUSION


Even if the addition of bevacizumab induced manageable toxicities including an increased risk of postoperative fistula and no treatment-related death, arm B did not achieve the expected pCR rate in the population of patients included. Induction bevacizumab-Folfox-4 followed by bevacizumab-5-FU-RT is promising. It is however necessary to continue investigations in the management of locally advanced RC. ClinicalTrials.gov Identifier: NCT 00865189.",2014,"In arm A, the rate of pCR was 23.8% [95% confidence interval (CI) 12.1% to 39.5%] statistically superior to the defined standard rate of 10%, P = 0.015.","['MRI-defined locally advanced T3 resectable rectal cancer', 'MRI-defined locally advanced T3 resectable RC', 'Forty-six patients were randomized in arm A and 45 patients in arm B']","['T3 rectal cancer (RC), preoperative chemoradiotherapy [5-fluorouracil (5-FU-RT', 'bevacizumab-5-FU-RT before TME', 'bevacizumab', 'Induction bevacizumab-Folfox-4 followed by bevacizumab-5-FU-RT', 'bevacizumab plus 5-FU, leucovorin and oxaliplatin (Folfox-4) followed with bevacizumab-5-FU-RT before total mesorectal excision (TME']","['pCR rate', 'risk of postoperative fistula', 'manageable toxicities', 'Postoperative fistulas', 'overall survival', 'death', 'Pathological response and safety', 'local recurrences', 'rate of pCR', 'pathological complete response (pCR) rate']","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0558429', 'cui_str': 'Postoperative fistula (disorder)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",46.0,0.0878866,"In arm A, the rate of pCR was 23.8% [95% confidence interval (CI) 12.1% to 39.5%] statistically superior to the defined standard rate of 10%, P = 0.015.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon and CIC-BT506, Besançon. Electronic address: christophe.borg@efs.sante.fr.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Saint Antoine Hospital and Pierre and Marie Curie University, Paris.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mantion', 'Affiliation': 'Department of Digestive and Liver Surgery, University Hospital of Besançon, Besançon.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Boudghène', 'Affiliation': 'Department of Radiology, Tenon Hospital, Paris.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mornex', 'Affiliation': 'Department of Radiotherapy, Lyon-Sud Hospital Center, Lyon.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maingon', 'Affiliation': 'Department of Radiotherapy, Georges-François-Leclerc Center, Dijon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adenis', 'Affiliation': 'Department of Medical Oncology, Oscar Lambret Center, Lille.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Azria', 'Affiliation': ""Department of Radiotherapy, Centre de Lutte Contre le Cancer Val D'Aurelle, Montpellier.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piutti', 'Affiliation': 'Roche Laboratories, Boulogne-Billancourt.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Morsli', 'Affiliation': 'Roche Laboratories, Boulogne-Billancourt.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Bosset', 'Affiliation': 'Department of Radiotherapy, University Hospital of Besançon, Besançon, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu377']
3336,25139550,A phase II randomized study evaluating the addition of iniparib to gemcitabine plus cisplatin as first-line therapy for metastatic non-small-cell lung cancer.,"BACKGROUND


Iniparib is a novel anticancer agent initially considered a poly (ADP-ribose) polymerase (PARP) inhibitor, but subsequently shown to act via non-selective protein modification through cysteine adducts. This randomized phase II study investigated the addition of iniparib to gemcitabine-cisplatin in metastatic non-small-cell lung cancer (NSCLC) patients.
PATIENTS AND METHODS


Patients with histologically confirmed stage IV NSCLC were randomized 2 : 1 to receive gemcitabine (1250 mg/m(2), days 1/8) and cisplatin (75 mg/m(2), day 1) with [gemcitabine/cisplatin/iniparib (GCI)] or without [gemcitabine/cisplatin (GC)] iniparib (5.6 mg/kg, days 1/4/8/11) every 3 weeks for six cycles. The primary end point was the overall response rate (ORR). Secondary objectives included progression-free survival (PFS), overall survival (OS), and safety. The study was not designed for formal efficacy comparison, the control arm being to benchmark results against the literature.
RESULTS


One hundred and nineteen patients were randomized (39 GC and 80 GCI). More GCI patients were male (80% GCI and 67% GC) and had PS 0 (61% GCI and 49% GC). The ORR was 25.6% [95% confidence interval (CI) 13.0%-42.1%] with GC versus 20.0% (95% CI 11.9%-30.4%) with GCI, which did not allow rejection of the null hypothesis (ORR with GCI ≤20%; P = 0.545). Median PFS was 4.3 (95% CI 2.8-5.6) months with GC and 5.7 (95% CI 4.6-6.6) months with GCI (hazard ratio 0.89, 95% CI 0.56-1.40). Median OS was 8.5 (95% CI 5.5 to not reached) months with GC, and 12.0 (95% CI 8.9-17.1) months with GCI (hazard ratio 0.78, 95% CI 0.48-1.27). More GCI patients received second-line treatment (51% GC and 68% GCI). Toxicity was similar in the two arms. Grade 3-4 toxicities included asthenia (28% GC and 8% GCI), nausea (3% GC and 14% GCI), and decreased appetite (10% in each).
CONCLUSIONS


Addition of iniparib to GC did not improve ORR over GC alone. The GCI safety profile was comparable to GC alone. Imbalances in PS and gender distribution may have impacted study results regarding PFS and OS.
TRIAL REGISTRATION


ClinicalTrial.gov Identifier NCT01086254.",2014,"Median PFS was 4.3 (95% CI 2.8-5.6) months with GC and 5.7 (95% CI 4.6-6.6) months with GCI (hazard ratio 0.89, 95% CI 0.56-1.40).","['One hundred and nineteen patients', 'metastatic non-small-cell lung cancer', 'Patients with histologically confirmed stage IV NSCLC', 'metastatic non-small-cell lung cancer (NSCLC) patients']","['gemcitabine', 'cisplatin', 'gemcitabine/cisplatin/iniparib (GCI)] or without [gemcitabine/cisplatin (GC)] iniparib', 'iniparib to gemcitabine plus cisplatin', 'gemcitabine-cisplatin']","['progression-free survival (PFS), overall survival (OS), and safety', 'appetite', 'overall response rate (ORR', 'Grade 3-4 toxicities included asthenia', 'nausea', 'GCI safety profile', 'Median PFS', 'Median OS', 'ORR', 'Toxicity']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0291482', 'cui_str': '4-iodo-3-nitrobenzamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",119.0,0.194968,"Median PFS was 4.3 (95% CI 2.8-5.6) months with GC and 5.7 (95% CI 4.6-6.6) months with GCI (hazard ratio 0.89, 95% CI 0.56-1.40).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, AOU San Luigi, Orbassano, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Thoracic Cancer Unit, Department of Medicine, Gustave-Roussy, Villejuif, France. Electronic address: benjamin.besse@gustaveroussy.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Department of Pneumology and Allergies, CHU Toulouse Hôpital Larrey, Toulouse.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'Department of Pneumology, CHU Côte de Nacre, Caen, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'von Pawel', 'Affiliation': 'Department of Oncology, Asklepios Fachkliniken München-Gauting, Gauting.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Thoracic Oncology, LungenClinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cappuzzo', 'Affiliation': 'Department of Medical Oncology, Istituto Toscano Tumori-Ospedale Civile, Livorno, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Department of Oncology, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carcereny', 'Affiliation': 'Department of Medical Oncology, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Medical Oncology, Humanitas Cancer Center IRCCS, Milan, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Garcia-Ribas', 'Affiliation': 'Oncology Division, Sanofi Aventis, Barcelona, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology, University of Turin, AOU San Luigi, Orbassano, Italy.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Soria', 'Affiliation': 'Thoracic Cancer Unit, Department of Medicine, Gustave-Roussy, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu384']
3337,23117073,"Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.","BACKGROUND


We evaluated the efficacy and safety of single-dose fosaprepitant in combination with intravenous granisetron and dexamethasone.
PATIENTS AND METHODS


Patients receiving chemotherapy including cisplatin (≥70 mg/m(2)) were eligible. A total of 347 patients (21% had received cisplatin with vomiting) were enrolled in this trial to receive the fosaprepitant regimen (fosaprepitant 150 mg, intravenous, on day 1 in combination with granisetron, 40 μg/kg, intravenous, on day 1 and dexamethasone, intravenous, on days 1-3) or the control regimen (placebo plus intravenous granisetron and dexamethasone). The primary end point was the percentage of patients who had a complete response (no emesis and no rescue therapy) over the entire treatment course (0-120 h).
RESULTS


The percentage of patients with a complete response was significantly higher in the fosaprepitant group than in the control group (64% versus 47%, P = 0.0015). The fosaprepitant regimen was more effective than the control regimen in both the acute (0-24 h postchemotherapy) phase (94% versus 81%, P = 0.0006) and the delayed (24-120 h postchemotherapy) phase (65% versus 49%, P = 0.0025).
CONCLUSIONS


Single-dose fosaprepitant used in combination with granisetron and dexamethasone was well-tolerated and effective in preventing chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic cancer chemotherapy, including high-dose cisplatin.",2013,"The percentage of patients with a complete response was significantly higher in the fosaprepitant group than in the control group (64% versus 47%, P = 0.0015).","['patients receiving highly emetogenic cancer chemotherapy, including high-dose', 'patients receiving high-dose', '≥70 mg/m(2)) were eligible', '347 patients (21% had received cisplatin with vomiting', 'Patients receiving']","['control regimen (placebo plus intravenous granisetron and dexamethasone', 'granisetron and dexamethasone', 'placebo', 'cisplatin', 'fosaprepitant regimen (fosaprepitant 150 mg, intravenous, on day 1 in combination with granisetron', 'chemotherapy including cisplatin', 'single-dose fosaprepitant']","['percentage of patients who had a complete response (no emesis and no rescue therapy', 'nausea and vomiting', 'percentage of patients with a complete response', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C4074639', 'cui_str': 'fosaprepitant 150 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",347.0,0.17208,"The percentage of patients with a complete response was significantly higher in the fosaprepitant group than in the control group (64% versus 47%, P = 0.0015).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Okazaki, Japan. hsaito@acc-aichi.com'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yoshizawa', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yoshimori', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katsumata', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kawahara', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eguchi', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds541']
3338,24603643,"A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy.","BACKGROUND


Antiemetic guidelines recommend co-administration of agents that target multiple molecular pathways involved in emesis to maximize prevention and control of chemotherapy-induced nausea and vomiting (CINV). NEPA is a new oral fixed-dose combination of 300 mg netupitant, a highly selective NK1 receptor antagonist (RA) and 0.50 mg palonosetron (PALO), a pharmacologically and clinically distinct 5-HT3 RA, which targets dual antiemetic pathways.
PATIENTS AND METHODS


This multinational, randomized, double-blind, parallel group phase III study (NCT01339260) in 1455 chemotherapy-naïve patients receiving moderately emetogenic (anthracycline-cyclophosphamide) chemotherapy evaluated the efficacy and safety of a single oral dose of NEPA versus a single oral dose (0.50 mg) of PALO. All patients also received oral dexamethasone (DEX) on day 1 only (12 mg in the NEPA arm and 20 mg in the PALO arm). The primary efficacy end point was complete response (CR: no emesis, no rescue medication) during the delayed (25-120 h) phase in cycle 1.
RESULTS


The percentage of patients with CR during the delayed phase was significantly higher in the NEPA group compared with the PALO group (76.9% versus 69.5%; P = 0.001), as were the percentages in the overall (0-120 h) (74.3% versus 66.6%; P = 0.001) and acute (0-24 h) (88.4% versus 85.0%; P = 0.047) phases. NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea). NEPA was well tolerated with a similar safety profile as PALO.
CONCLUSIONS


NEPA plus a single dose of DEX was superior to PALO plus DEX in preventing CINV following moderately emetogenic chemotherapy in acute, delayed and overall phases of observation. As a fixed-dose antiemetic drug combination, NEPA along with a single dose of DEX on day 1 offers guideline-based prophylaxis with a convenient, single-day treatment.",2014,"NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea).",['1455 chemotherapy-naïve patients receiving moderately'],"['highly selective NK1 receptor antagonist (RA) and 0.50 mg palonosetron (PALO', 'DEX', 'NEPA', 'emetogenic (anthracycline-cyclophosphamide) chemotherapy', 'PALO plus DEX', 'PALO', 'oral dexamethasone (DEX', 'netupitant and palonosetron', 'moderately emetogenic chemotherapy']","['efficacy and safety', 'nausea and vomiting', 'complete response (CR: no emesis, no rescue medication', 'nausea and complete protection (CR plus no significant nausea']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",1455.0,0.0921796,"NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aapro', 'Affiliation': ""Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland. Electronic address: maapro@genolier.net.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rugo', 'Affiliation': 'Comprehensive Cancer Center, University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Corporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Corporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Borroni', 'Affiliation': 'Corporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Department of Oncology, Dnepropetrovsk Medical Academy, Dnepropetrovsk, Ukraine.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sarosiek', 'Affiliation': 'Nzoz Magodent, Warsaw, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oprean', 'Affiliation': 'Oncomed SRL, Timisoara, Romania.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cardona-Huerta', 'Affiliation': 'Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey, Mexico.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'National Cancer Institute Giovanni Paolo II, Bari, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Department of Hematology, Oncology and Palliative Medicine, Staedt. Klinikum Neuperlach and Harlaching, München, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'The West Clinic, Memphis.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grunberg', 'Affiliation': 'Fletcher Allen Health Care, Burlington, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu101']
3339,24827134,"Phase II, randomized, biomarker identification trial (MARK) for erlotinib in patients with advanced pancreatic carcinoma.","BACKGROUND


A prospective, randomized phase II study, with mandatory tumor sampling at current disease stage, aimed to identify biomarkers predictive of improved progression-free survival (PFS) in patients with pancreatic cancer treated with erlotinib.
PATIENTS AND METHODS


Patients with histologically/cytologically confirmed, unresectable, locally advanced/metastatic pancreatic cancer, who had failed on or were unsuitable for first-line chemotherapy, underwent a tumor biopsy and were then randomized to receive once-daily erlotinib 150 mg or placebo. The primary end point was identification of biomarkers predicting improved PFS with erlotinib. Secondary end points included PFS, overall survival, response and toxicity.
RESULTS


At data cut-off, 207 patients were enrolled and analyzed. Prespecified biomarker analyses of EGFR protein expression, EGFR gene copy number/mutations/polymorphisms and KRAS mutations did not identify any subgroups with a detrimental effect or a strong benefit for PFS with erlotinib. In the primary analysis, the median PFS was 6.1 versus 5.9 weeks in the erlotinib and placebo arms, respectively [hazard ratio (HR) 0.83; 95% confidence interval (CI) 0.63-1.10; P = 0.1909]. However, observed baseline imbalances indicated worse prognosis in the erlotinib arm. After adjustment for baseline characteristics, a significant PFS benefit for erlotinib was observed (HR 0.68; 95% CI 0.50-0.91; P = 0.0102). Exploratory biomarker analyses showed patients with high baseline serum amphiregulin levels might benefit from erlotinib.
CONCLUSION


This study in patients with inoperable pancreatic cancer did not identify any prespecified biomarkers predictive of PFS benefit with erlotinib. Exploratory analyses suggested high amphiregulin might predict PFS benefit from erlotinib.
CLINICALTRIALSGOV NUMBER


NCT00674973.",2014,"After adjustment for baseline characteristics, a significant PFS benefit for erlotinib was observed (HR 0.68; 95% CI 0.50-0.91; P = 0.0102).","['207 patients were enrolled and analyzed', 'patients with advanced pancreatic carcinoma', 'patients with inoperable pancreatic cancer', 'patients with pancreatic cancer treated with erlotinib', 'Patients with histologically/cytologically confirmed, unresectable, locally advanced/metastatic pancreatic cancer, who had failed on or were unsuitable for first-line chemotherapy, underwent a tumor biopsy']","['erlotinib', 'placebo', 'erlotinib 150 mg or placebo']","['median PFS', 'PFS benefit for erlotinib', 'progression-free survival (PFS', 'PFS, overall survival, response and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0235974', 'cui_str': 'Pancreatic Acinar Carcinoma'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2978152', 'cui_str': 'erlotinib 150 MG [Tarceva]'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",207.0,0.171901,"After adjustment for baseline characteristics, a significant PFS benefit for erlotinib was observed (HR 0.68; 95% CI 0.50-0.91; P = 0.0102).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: d.j.propper@qmul.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Davidenko', 'Affiliation': 'State Medical Institution Clinical Oncology Dispensary, Krasnodar, Russia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College London Cancer Institute, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kupcinskas', 'Affiliation': 'Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fittipaldo', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hillenbach', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Klughammer', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu176']
3340,22851406,Clinical benefit in patients with metastatic bone disease: results of a phase 3 study of denosumab versus zoledronic acid.,"BACKGROUND


Patients with metastatic bone disease are living longer in the metastatic stage due to improvements in cancer therapy, making strategies to prevent the aggravation of bone disease and its complications, such as skeletal-related events (SREs) and pain, increasingly important.
PATIENTS AND RESULTS


In this phase 3 trial in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma, denosumab reduced the risk of radiation to bone by 22% relative to zoledronic acid (P = 0.026), prevented worsening of pain and pain interference (2-point increase in Brief Pain Inventory score; P < 0.05 versus zoledronic acid), and reduced the frequency of a shift from no/weak opioid analgesic use to strong opioids (P < 0.05 versus zoledronic acid at months 3-5). Denosumab delayed the time to moderate-to-severe pain compared with zoledronic acid in patients with mild or no pain at the baseline (P = 0.04), supporting early treatment. Health-related quality-of-life scores were similar in both groups. The number needed to treat to avoid one SRE for denosumab was 3 patient-years versus placebo and 10 patient-years versus zoledronic acid.
CONCLUSION


The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid.",2012,The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid.,"['patients with advanced cancer (excluding breast and prostate cancer', 'Patients with metastatic bone disease', 'patients with metastatic bone disease']","['placebo', 'denosumab', 'Denosumab', 'denosumab versus zoledronic acid', 'zoledronic acid']","['worsening of pain and pain interference', 'risk of radiation to bone', 'time to moderate-to-severe pain', 'Health-related quality-of-life scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0523845,The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vadhan-Raj', 'Affiliation': 'Division of Cancer Medicine, Department of Sarcoma Medical Oncology and Lymphoma/Myeloma, Section of Cytokines and Supportive Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: svadhanr@mdanderson.org.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'von Moos', 'Affiliation': 'Department of Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), University of Sussex, Brighton, UK.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Patrick', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Goldwasser', 'Affiliation': 'Department of Medical Oncology, Paris Descartes University, AP-HP, Paris, France.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Cleeland', 'Affiliation': 'Department of Symptom Research, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Henry', 'Affiliation': 'Department of Hematology-Oncology, Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Orbassano, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Department of Hematology, Irmandade da Santa Casa de Misericordia de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': 'Global Biostatistical Sciences, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feng', 'Affiliation': 'Global Biostatistical Sciences, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yeh', 'Affiliation': 'Clinical Development, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chung', 'Affiliation': 'Global Health Economics, Amgen Inc., Thousand Oaks, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds175']
3341,22858558,Hypertension as a potential biomarker of efficacy in patients with gastrointestinal stromal tumor treated with sunitinib.,"BACKGROUND


Reliable biomarkers of sunitinib response in gastrointestinal stromal tumor (GIST) are lacking. Hypertension (HTN), an on-target class effect of vascular endothelial growth factor signaling-pathway inhibitors, has been shown to correlate with clinical outcome in advanced renal cell carcinoma treated with sunitinib.
PATIENTS AND METHODS


This retrospective analysis examined correlations between sunitinib-associated HTN and antitumor efficacy (N = 319) and safety (N = 1565) across three advanced GIST studies. Blood pressure (BP) was measured on days 1 and 28 of each treatment cycle at a minimum. Time-to-event endpoints were estimated using Kaplan-Meier methods, and patient subgroups with and without HTN (maximum systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) were compared using Cox proportional hazards models. Landmark analyses evaluated associations between early HTN and efficacy endpoints. Adverse events (AEs) were compared between groups.
RESULTS


Sunitinib-associated HTN correlated with improved objective response rates, time to tumor progression, progression-free survival, and overall survival. Almost all benefits remained significant in multivariate and landmark analyses. Overall incidences of HTN-related AEs were low and similar between groups; incidences of cardiovascular AEs were somewhat higher in patients with HTN.
CONCLUSION


Sunitinib-associated HTN appeared to correlate with improved clinical outcomes in GIST, while incidences of HTN-associated AEs were generally low and manageable.",2012,"RESULTS


Sunitinib-associated HTN correlated with improved objective response rates, time to tumor progression, progression-free survival, and overall survival.","['advanced renal cell carcinoma treated with sunitinib', 'patients with gastrointestinal stromal tumor treated with sunitinib']",[],"['Adverse events (AEs', 'Blood pressure (BP', 'objective response rates, time to tumor progression, progression-free survival, and overall survival', 'cardiovascular AEs']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.071833,"RESULTS


Sunitinib-associated HTN correlated with improved objective response rates, time to tumor progression, progression-free survival, and overall survival.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA. Electronic address: suzanne_george@dfci.harvard.edu.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Department of Internal Medicine, HELIOS Klinikum Bad Saarow, Bad Saarow, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lechner', 'Affiliation': 'Pfizer Oncology, New York, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Pfizer Oncology, Shanghai, China.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Cohen', 'Affiliation': 'Pfizer Oncology, La Jolla, USA.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Demetri', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Ludwig Center at Dana-Farber/Harvard Cancer Center, Harvard Medical School, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds179']
3342,24631949,"A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy.","BACKGROUND


Safe, effective and convenient antiemetic regimens that preserve benefit over repeated cycles are needed for optimal supportive care during cancer treatment. NEPA, an oral fixed-dose combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron (PALO), a distinct 5-HT3 RA, was shown to be superior to PALO in preventing chemotherapy-induced nausea and vomiting after a single cycle of highly (HEC) or moderately (MEC) emetogenic chemotherapy in recent trials. This study was designed primarily to assess the safety but also to evaluate the efficacy of NEPA over multiple cycles of HEC and MEC.
PATIENTS AND METHODS


This multinational, double-blind, randomized phase III study (NCT01376297) in 413 chemotherapy-naïve patients evaluated a single oral dose of NEPA (NETU 300 mg + PALO 0.50 mg) given on day 1 with oral dexamethasone (DEX). An oral 3-day aprepitant (APR) regimen + PALO + DEX was included as a control (3:1 NEPA:APR randomization). In HEC, DEX was administered on days 1-4 and in MEC on day 1. Safety was assessed primarily by adverse events (AEs), including cardiac AEs; efficacy by complete response (CR: no emesis, no rescue).
RESULTS


Patients completed 1961 total chemotherapy cycles (76% MEC, 24% HEC) with 75% completing ≥4 cycles. The incidence/type of AEs was comparable for both groups. Most frequent NEPA-related AEs included constipation (3.6%) and headache (1.0%); there was no indication of increasing AEs over multiple cycles. The majority of AEs were mild/moderate and there were no cardiac safety concerns based on AEs and electrocardiograms. The overall (0-120 h) CR rates in cycle 1 were 81% and 76% for NEPA and APR + PALO, respectively, and antiemetic efficacy was maintained over repeated cycles.
CONCLUSIONS


NEPA, a convenient single oral dose antiemetic targeting dual pathways, was safe, well tolerated and highly effective over multiple cycles of HEC/MEC.",2014,Most frequent NEPA-related AEs included constipation (3.6%) and headache (1.0%); there was no indication of increasing AEs over multiple cycles.,['413 chemotherapy-naïve patients'],"['NEPA', 'NEPA, an oral fixed-dose combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron (PALO', 'NEPA (NETU 300 mg + PALO 0.50 mg) given on day 1 with oral dexamethasone (DEX', 'chemotherapy', 'HEC, DEX', 'netupitant and palonosetron', 'oral 3-day aprepitant (APR) regimen + PALO + DEX']","['nausea and vomiting', 'incidence/type of AEs', 'adverse events (AEs), including cardiac AEs; efficacy by complete response (CR: no emesis, no rescue', 'headache', 'antiemetic efficacy', 'constipation', 'CR rates']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0068213', 'cui_str': 'NETU'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",,0.112653,Most frequent NEPA-related AEs included constipation (3.6%) and headache (1.0%); there was no indication of increasing AEs over multiple cycles.,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Department of Medical Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, USA. Electronic address: richard.gralla@nbhn.net.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Bosnjak', 'Affiliation': 'Department of Supportive Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Chernivtsi Regional Cancer Hospital, Chernivtsi, Ukraine.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Balser', 'Affiliation': 'OnkoNet Marburg GmbH, Marburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Department of Statistics and Data Management.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Department of Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Borroni', 'Affiliation': 'Department of Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': 'Department of Hematology and Oncology, University of Halle-Wittenberg, Halle, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu096']
3343,31349850,ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial.,"BACKGROUND


South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes.
METHODS


This is a prospective, multicentre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in three provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in three different health districts in South Africa. Participants randomised individually to the intervention arm will receive three MI counselling sessions one month apart. Each MI session will be followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use, and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at the three-month and six-month follow-ups.
DISCUSSION


This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of lifestyle, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings.
TRIAL REGISTRATION


ISRCTN Registry, ISRCTN62728852. Registered on 13 April 2018.",2019,"If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings.
","['three provinces of South Africa', '696 adult participants (aged 18\u2009years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use', 'Patients will be consecutively enrolled at 27 clinics in three different health districts in South Africa']","['motivational intervention followed by short text messages (ProLife', 'combined MI and SMS interventions', 'complex behavioural intervention (the ProLife programme']","['smoking cessation, reduction in alcohol use, and TB medication and anti-retroviral therapy adherence']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C3241966'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",696.0,0.103026,"If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings.
","[{'ForeName': 'Andrew Stephen', 'Initials': 'AS', 'LastName': 'Moriarty', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York, York, UK. andrewmoriarty1@doctors.org.uk.'}, {'ForeName': 'Goedele Maria', 'Initials': 'GM', 'LastName': 'Louwagie', 'Affiliation': 'School of Health Systems and Public Health, University of Pretoria and Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.'}, {'ForeName': 'Noreen Dadirai', 'Initials': 'ND', 'LastName': 'Mdege', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Neo', 'Initials': 'N', 'LastName': 'Morojele', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tumbo', 'Affiliation': 'Department of Family Medicine, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.'}, {'ForeName': 'Olufemi Babatunde', 'Initials': 'OB', 'LastName': 'Omole', 'Affiliation': 'Department of Family Medicine, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Max Oscar', 'Initials': 'MO', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kanaan', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'School of Health Systems and Public Health, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Olalekan Abdulwahab', 'Initials': 'OA', 'LastName': 'Ayo-Yusuf', 'Affiliation': 'Africa Centre for Tobacco Industry Monitoring and Policy Research, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.'}]",Trials,['10.1186/s13063-019-3551-9']
3344,22291207,Health-related quality of life in recurrent platinum-sensitive ovarian cancer--results from the CALYPSO trial.,"BACKGROUND


In the CALYPSO trial, carboplatin-pegylated liposomal doxorubicin (CD) demonstrated superior therapeutic index versus carboplatin-paclitaxel (CP) in patients with recurrent ovarian cancer. This paper reports the health-related quality of life (HRQoL) findings.
MATERIALS AND METHODS


HRQoL was measured with the EORTC QoL-QC30 questionnaire and OV28 ovarian cancer module. Mean change scores from baseline in HRQoL subscales (five functional scales and global health status) in each arm and the proportion of patients improved or worsened were calculated every 3 months until 12 months.
RESULTS


Compliance was 90% at baseline and 76%, 64%, 57% at 3, 6, and 9 months, respectively. Baseline HRQoL showed already impaired global scores (mean 62/100) and considerable symptom burden (90% of patients reporting nonzero scores). Global QoL and abdominal symptom scores improved over time in both arms; at 6 months, 36% of patients met criteria for improved symptoms. Treatment with CD resulted in less peripheral neuropathy (9.8 versus 24.2), fewer other chemotherapy side-effects (9.5 versus 16.2), and less impact on body image (3.8 versus 10.4) versus CP (all P<0.02) at 6 months.
CONCLUSIONS


These patient-reported outcomes confirm the overall lower toxicity of CD versus CP. The improved disease-related outcomes achieved with CD were not at the expense of QoL.",2012,"Global QoL and abdominal symptom scores improved over time in both arms; at 6 months, 36% of patients met criteria for improved symptoms.",['patients with recurrent ovarian cancer'],"['CD', 'carboplatin-paclitaxel (CP', 'carboplatin-pegylated liposomal doxorubicin (CD']","['Health-related quality of life', 'body image', 'symptom burden', 'HRQoL subscales (five functional scales and global health status', 'chemotherapy side-effects', 'global scores', 'peripheral neuropathy', 'Global QoL and abdominal symptom scores', 'EORTC QoL-QC30 questionnaire and OV28 ovarian cancer module']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]",,0.0808813,"Global QoL and abdominal symptom scores improved over time in both arms; at 6 months, 36% of patients met criteria for improved symptoms.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brundage', 'Affiliation': ""NCIC Clinical Trials Group; Department of Medical Oncology, Queen's University, Kingston, Canada. Electronic address: michael.brundage@krcc.on.ca.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gropp', 'Affiliation': 'Department of Medical Oncology, AGO, Düsseldorf, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mefti', 'Affiliation': 'Department of Medical Oncology, GINECO, Saint-Cloud, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mann', 'Affiliation': 'Department of Medical Oncology, National Health and Medical Research Council Clinical Trials Centre, Sydney, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': 'Department of Oncology, Aalborg Hospital, Aalborg, Denmark.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wolfram', 'Affiliation': 'Department of Gynecology, Arbeitsgemeinschaft Gynaekologische Onkologie-Austria, Ried, Austria.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Beatson Oncology Centre, Gartnavel General Hospital, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'Multicenter Italian Trials in Ovarian Cancer (MITO), Napoli.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'Academic Division of Gynecologic Oncology, Mauriziano Hospital, Torino, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Eisenhauer', 'Affiliation': ""NCIC Clinical Trials Group; Department of Medical Oncology, Queen's University, Kingston, Canada.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Department of Oncology, Hôpital Hôtel-Dieu, Paris, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr583']
3345,24567515,The role of body mass index in survival outcome for lymphoma patients: US intergroup experience.,"BACKGROUND


The role of body mass index (BMI) in survival outcomes is controversial among lymphoma patients. We evaluated the association between BMI at study entry and failure-free survival (FFS) and overall survival (OS) in three phase III clinical trials, among patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and Hodgkin's lymphoma (HL).
PATIENTS AND METHODS


A total of 537, 730 and 282 patients with DLBCL, HL and FL were included in the analysis. Baseline patient and clinical characteristics, treatment received and clinical outcomes were compared across BMI categories.
RESULTS


Among patients with DLBCL, HL and FL, the median age was 70, 33 and 56; 29%, 29% and 37% were obese and 38%, 27% and 37% were overweight, respectively. Age was significantly different among BMI groups in all three studies. Higher BMI groups tended to have more favorable prognosis factors at study entry among DLBCL and HL patients. BMI was not associated with clinical outcome with P-values of 0.89, 0.30 and 0.40 for FFS, and 0.64, 0.67 and 0.09 for OS, for patients with DLBCL, HL and FL, respectively. The association remains non-significant after adjusting for other clinical factors in the Cox model. A subset analysis of males with DLBCL treated on R-CHOP revealed no differences in FFS (P = 0.48) or OS (P = 0.58).
CONCLUSION


BMI was not significantly associated with clinical outcomes among patients with DLBCL, HD or FL, in three prospective phase III clinical trials. The findings contradict some previous reports of similar investigations. Further work is required to understand the observed discrepancies.",2014,"BMI was not associated with clinical outcome with P-values of 0.89, 0.30 and 0.40 for FFS, and 0.64, 0.67 and 0.09 for OS, for patients with DLBCL, HL and FL, respectively.","['A total of 537, 730 and 282 patients with DLBCL, HL and FL were included in the analysis', 'patients with DLBCL, HD or FL', 'patients with DLBCL, HL and FL, the median age was 70, 33 and 56; 29%, 29% and 37% were obese and 38%, 27% and 37% were overweight, respectively', 'lymphoma patients', ""patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and Hodgkin's lymphoma (HL""]",[],"['FFS', 'BMI', 'BMI at study entry and failure-free survival (FFS) and overall survival (OS']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]",[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0488677,"BMI was not associated with clinical outcome with P-values of 0.89, 0.30 and 0.40 for FFS, and 0.64, 0.67 and 0.09 for OS, for patients with DLBCL, HL and FL, respectively.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA. Electronic address: fxhong@jimmy.harvard.edu.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Gordon', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hochster', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, Canada.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Morrison', 'Affiliation': 'University of Minnesota, VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Washington University, St Louis, MO.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Stiff', 'Affiliation': 'Loyola University, Maywood, IL.'}, {'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Crump', 'Affiliation': 'Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Horning', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'University of Wisconsin, Madison, WI, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt594']
3346,24567516,"Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part).","BACKGROUND


Recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) overexpresses αvβ5 integrin. Cilengitide selectively inhibits αvβ3 and αvβ5 integrins and is investigated as a treatment strategy.
PATIENTS AND METHODS


The phase I/II study ADVANTAGE evaluated cilengitide combined with cisplatin, 5-fluorouracil, and cetuximab (PFE) in R/M-SCCHN. The phase II part reported here was an open-label, randomized, controlled trial investigating progression-free survival (PFS). Patients received up to six cycles of PFE alone or combined with cilengitide 2000 mg once (CIL1W) or twice (CIL2W) weekly. Thereafter, patients received maintenance therapy (cilengitide arms: cilengitide plus cetuximab; PFE-alone arm: cetuximab only) until disease progression or unacceptable toxicity.
RESULTS


One hundred and eighty-two patients were treated. Median PFS per investigator read was similar for CIL1W + PFE, CIL2W + PFE, and PFE alone (6.4, 5.6, and 5.7 months, respectively). Accordingly, median overall survival and objective response rates were not improved with cilengitide (12.4 months/47%, 10.6 months/27%, and 11.6 months/36%, respectively). No clinically meaningful safety differences were observed between groups. None of the tested biomarkers (expression of integrins, CD31, Ki-67, vascular endothelial growth factor receptor 2, vascular endothelial-cadherin, type IV collagen, epidermal growth factor receptor, or p16 for human papillomavirus) were predictive of outcome.
CONCLUSION


Neither of the cilengitide-containing regimens demonstrated a PFS benefit over PFE alone in R/M-SCCHN patients.",2014,"None of the tested biomarkers (expression of integrins, CD31, Ki-67, vascular endothelial growth factor receptor 2, vascular endothelial-cadherin, type IV collagen, epidermal growth factor receptor, or p16 for human papillomavirus) were predictive of outcome.
","['recurrent/metastatic squamous cell carcinoma of the head and neck', 'One hundred and eighty-two patients were treated', 'Recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) overexpresses αvβ5 integrin']","['Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide', 'maintenance therapy (cilengitide arms: cilengitide plus cetuximab; PFE-alone arm: cetuximab', 'cilengitide combined with cisplatin, 5-fluorouracil, and cetuximab (PFE', 'PFE alone or combined with cilengitide 2000 mg once (CIL1W) or twice (CIL2W) weekly']","['biomarkers (expression of integrins, CD31, Ki-67, vascular endothelial growth factor receptor 2, vascular endothelial-cadherin, type IV collagen, epidermal growth factor receptor, or p16 for human papillomavirus', 'progression-free survival (PFS', 'median overall survival and objective response rates', 'Median PFS per investigator read', 'PFS benefit']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0971473', 'cui_str': 'Cilengitide'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3853087', 'cui_str': 'Once or twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0378796', 'cui_str': 'Flk-1 Protein'}, {'cui': 'C0300423', 'cui_str': 'CD144 antigen'}, {'cui': 'C0009333', 'cui_str': 'Type IV (Basement Membrane) Collagen'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0249880', 'cui_str': 'Cyclin-Dependent Kinase Inhibitor p16'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",182.0,0.0401799,"None of the tested biomarkers (expression of integrins, CD31, Ki-67, vascular endothelial growth factor receptor 2, vascular endothelial-cadherin, type IV collagen, epidermal growth factor receptor, or p16 for human papillomavirus) were predictive of outcome.
","[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium. Electronic address: jan.b.vermorken@uza.be.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Peyrade', 'Affiliation': 'Medical Oncology Service, Center Antoine Lacassagne, Nice, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krauss', 'Affiliation': 'Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesía', 'Affiliation': ""Medical Oncology Service, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Remenar', 'Affiliation': 'Head and Neck Surgery, National Oncology Institute, Budapest, Hungary.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Gauler', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen, University Duisburg-Essen, Essen.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Department of Hematology and Medical Oncology, Charité Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Clinical Research Unit, Institute Claudius Regaud, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'II Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Erfán', 'Affiliation': 'Onco-radiology, Jósa András Teaching Hospital, Nyíregyháza, Hungary.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of the RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Iglesias', 'Affiliation': 'Lung and Head and Neck Cancer Unit, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Bethe', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hicking', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Oncology, KU Leuven, Leuven, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu003']
3347,22412041,"Bone effect of adjuvant tamoxifen, letrozole or letrozole plus zoledronic acid in early-stage breast cancer: the randomized phase 3 HOBOE study.","BACKGROUND


To measure bone mineral density (BMD) reduction produced by letrozole as compared with tamoxifen and the benefit of the addition of zoledronic acid.
PATIENTS AND METHODS


A phase 3 trial comparing tamoxifen, letrozole or letrozole+zoledronic acid in patients with hormone receptor-positive early breast cancer was conducted; triptorelin was given to premenopausal patients. Two comparisons were planned: letrozole versus tamoxifen and letrozole+zoledronic acid versus letrozole. Primary end point was the difference in 1-year change of T-score at lumbar spine (LTS) measured by dual energy X-ray absorptiometry scan.
RESULTS


Out of 483 patients enrolled, 459 were available for primary analyses. Median age was 50 (range 28-80). The estimated mean difference (95% confidence interval [CI]) in 1-year change of LTS was equal to -0.30 (95% CI -0.44 to -0.17) in the letrozole versus tamoxifen comparison (P<0.0001) and to +0.60 (95% CI +0.46 to +0.77) in the letrozole+zoledronic acid versus letrozole comparison (P<0.0001). Bone damage by letrozole decreased with increasing baseline body mass index in premenopausal, but not postmenopausal, patients (interaction test P=0.004 and 0.47, respectively).
CONCLUSIONS


In the HOBOE (HOrmonal BOne Effects) trial, the positive effect of zoledronic acid on BMD largely counteracts damage produced by letrozole as compared with tamoxifen. Letrozole effect is lower among overweight/obese premenopausal patients.",2012,Two comparisons were planned: letrozole versus tamoxifen and letrozole+zoledronic acid versus letrozole.,"['Median age was 50 (range 28-80', 'overweight/obese premenopausal patients', 'early-stage breast cancer', 'premenopausal patients', 'patients with hormone receptor-positive early breast cancer', '483 patients enrolled, 459 were available for primary analyses']","['adjuvant tamoxifen, letrozole or letrozole plus zoledronic acid', 'tamoxifen, letrozole or letrozole+zoledronic acid', 'triptorelin', 'tamoxifen', 'letrozole versus tamoxifen and letrozole+zoledronic acid versus letrozole', 'letrozole', 'Letrozole', 'letrozole+zoledronic acid versus letrozole', 'zoledronic acid']","['bone mineral density (BMD) reduction', '1-year change of LTS', '1-year change of T-score at lumbar spine (LTS']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}]",483.0,0.208277,Two comparisons were planned: letrozole versus tamoxifen and letrozole+zoledronic acid versus letrozole.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nuzzo', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gallo', 'Affiliation': 'Medical Statistics, Department of Medicine and Public Health, Second University, Napoli.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lastoria', 'Affiliation': 'Nuclear Medicine and Metabolic Therapy, Department of Imaging, National Cancer Institute, Napoli.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Piccirillo', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gravina', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Landi', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rossi', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli; Division of Medical Oncology, Department of Oncohematology, S. Giuseppe Moscati Hospital, Avellino.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pacilio', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Labonia', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Di Rella', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bartiromo', 'Affiliation': 'Nuclear Medicine and Metabolic Therapy, Department of Imaging, National Cancer Institute, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Buonfanti', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Feo', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Laboratory Medicine, Department of Pathology and Laboratory Diagnostics, National Cancer Institute, Napoli.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""D'Aniello"", 'Affiliation': 'Department of Pharmacy, National Cancer Institute, Napoli.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maiolino', 'Affiliation': 'Department of Pharmacy, National Cancer Institute, Napoli.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Signoriello', 'Affiliation': 'Medical Statistics, Department of Medicine and Public Health, Second University, Napoli.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'De Maio', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Tinessa', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Rummo Hospital, Benevento.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Colantuoni', 'Affiliation': 'Division of Medical Oncology, Department of Oncohematology, S. Giuseppe Moscati Hospital, Avellino.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""D'Aiuto"", 'Affiliation': 'Division of Surgical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Bonito', 'Affiliation': 'Pathology, Department of Pathology and Laboratory Diagnostics, National Cancer Institute, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Botti', 'Affiliation': 'Pathology, Department of Pathology and Laboratory Diagnostics, National Cancer Institute, Napoli.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Giordano', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Normanno', 'Affiliation': 'Cellular Biology and Biotherapy, Department of Research, National Cancer Institute, Napoli, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Matteis', 'Affiliation': 'Medical Oncology, Department of Senology, National Cancer Institute, Napoli.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Clinical Trials Unit, Department of Research, National Cancer Institute, Napoli. Electronic address: francesco.perrone@usc-intnapoli.net.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr600']
3348,22415585,Treatment and outcome of Wilms' tumour patients: an analysis of all cases registered in the UKW3 trial.,"BACKGROUND


The randomised findings of the UKW3 trial were that preoperative chemotherapy was associated with a more advantageous stage distribution and reduction in therapy burden versus immediate nephrectomy without compromising outcome in localised Wilms' tumour (WT). We analysed outcome in all WT registered in UKW3.
PATIENTS AND METHODS


Seven hundred and eighteen WT cases (7% anaplastic) were registered in UKW3. We assigned a treatment stage and conducted survival analysis.
RESULTS


Five-year event-free survival (EFS) and overall survival (OS) were 77.2% [95% confidence interval (CI) 73.9-80.2] and 87.5% (95% CI 84.8-89.7) after median follow-up of 9.5 years and 10.0 years, respectively. Five-year OS in localised non-anaplastic cases was 92.9% (95% CI 90.2-94.9). Anaplasia was associated with adverse outcome compared with non-anaplastic cases: 5-year EFS of 42.0% (95% CI 28.3-55.1) versus 79.8% (95% CI 76.5-82.7) and 5-year OS of 60% (95% CI 45.1-72.0) versus 89.6% (95% CI 87.0-91.7), respectively. Outcomes were similar for non-anaplastic stage I or II but significantly poorer in stage III cases than stage I. Five-year OS after relapse was 54.1% (95% CI 44.5-62.8). Forty-seven percent of non-anaplastic WT received anthracycline; 27% were treated with radiotherapy first line.
CONCLUSION


These outcomes provide a baseline for future comparisons of WT treatment approach, burden and patient outcome.",2012,"RESULTS


Five-year event-free survival (EFS) and overall survival (OS) were 77.2% [95% confidence interval (CI) 73.9-80.2] and 87.5% (95% CI 84.8-89.7) after median follow-up of 9.5 years and 10.0 years, respectively.","[""Wilms' tumour patients""]","['radiotherapy', 'anthracycline']","['free survival (EFS) and overall survival (OS', '5-year OS']","[{'cui': 'C0027708', 'cui_str': 'Wilms Tumor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",718.0,0.488381,"RESULTS


Five-year event-free survival (EFS) and overall survival (OS) were 77.2% [95% confidence interval (CI) 73.9-80.2] and 87.5% (95% CI 84.8-89.7) after median follow-up of 9.5 years and 10.0 years, respectively.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pritchard-Jones', 'Affiliation': 'Molecular Haematology and Cancer Biology Unit, Institute of Child Health, University College London, London. Electronic address: k.pritchard-jones@ucl.ac.uk.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moroz', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vujanić', 'Affiliation': 'Department of Pathology, School of Medicine, Cardiff University, Cardiff.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Powis', 'Affiliation': 'Department of Paediatric Surgery, Leeds Teaching Hospitals NHS Trust, Leeds.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Department of Paediatric Surgery, Royal Hallamshire Hospital, Sheffield.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Messahel', 'Affiliation': 'Section of Paediatric Oncology, Institute of Cancer Research, Sutton.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hobson', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Levitt', 'Affiliation': 'Department of Haematology and Oncology, Great Ormond Street Hospital for Children NHS Trust, London.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kelsey', 'Affiliation': ""Department of Pathology, Royal Manchester Children's Hospital, Manchester.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Department of Paediatric Oncology, Oxford Radcliffe Hospitals NHS Trust, Oxford, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds025']
3349,25164908,Two biomarker-directed randomized trials in European and Chinese patients with nonsmall-cell lung cancer: the BRCA1-RAP80 Expression Customization (BREC) studies.,"BACKGROUND


In a Spanish Lung Cancer Group (SLCG) phase II trial, the combination of BRCA1 and receptor-associated protein 80 (RAP80) expression was significantly associated with outcome in Caucasian patients with nonsmall-cell lung cancer (NSCLC). The SLCG therefore undertook an industry-independent collaborative randomized phase III trial comparing nonselected cisplatin-based chemotherapy with therapy customized according to BRCA1/RAP80 expression. An analogous randomized phase II trial was carried out in China under the auspices of the SLCG to evaluate the effect of BRCA1/RAP80 expression in Asian patients.
PATIENTS AND METHODS


Eligibility criteria included stage IIIB-IV NSCLC and sufficient tumor specimen for molecular analysis. Randomization to the control or experimental arm was 1 : 1 in the SLCG trial and 1 : 3 in the Chinese trial. In both trials, patients in the control arm received docetaxel/cisplatin; in the experimental arm, patients with low RAP80 expression received gemcitabine/cisplatin, those with intermediate/high RAP80 expression and low/intermediate BRCA1 expression received docetaxel/cisplatin, and those with intermediate/high RAP80 expression and high BRCA1 expression received docetaxel alone. The primary end point was progression-free survival (PFS).
RESULTS


Two hundred and seventy-nine patients in the SLCG trial and 124 in the Chinese trial were assessable for PFS. PFS in the control and experimental arms in the SLCG trial was 5.49 and 4.38 months, respectively [log rank P = 0.07; hazard ratio (HR) 1.28; P = 0.03]. In the Chinese trial, PFS was 4.74 and 3.78 months, respectively (log rank P = 0.82; HR 0.95; P = 0.82).
CONCLUSION


Accrual was prematurely closed on the SLCG trial due to the absence of clinical benefit in the experimental over the control arm. However, the BREC studies provide proof of concept that an international, nonindustry, biomarker-directed trial is feasible. Thanks to the groundwork laid by these studies, we expect that ongoing further research on alternative biomarkers to elucidate DNA repair mechanisms will help define novel therapeutic approaches.
TRIAL REGISTRATION


NCT00617656/GECP-BREC and ChiCTR-TRC-12001860/BREC-CHINA.",2014,"In the Chinese trial, PFS was 4.74 and 3.78 months, respectively (log rank P = 0.82; HR 0.95; P = 0.82).
","['European and Chinese patients with nonsmall-cell lung cancer', 'Asian patients', 'Two hundred and seventy-nine patients in the SLCG trial and 124 in the Chinese trial were assessable for PFS', 'Eligibility criteria included stage IIIB-IV NSCLC and sufficient tumor specimen for molecular analysis', 'Caucasian patients with nonsmall-cell lung cancer (NSCLC']","['nonselected cisplatin-based chemotherapy', 'gemcitabine/cisplatin', 'docetaxel alone', 'docetaxel/cisplatin']","['PFS', 'progression-free survival (PFS']","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",279.0,0.0668354,"In the Chinese trial, PFS was 4.74 and 3.78 months, respectively (log rank P = 0.82; HR 0.95; P = 0.82).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moran', 'Affiliation': 'Catalan Institute of Oncology, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Medical Oncology Service, Hospital Carlos Haya, Malaga.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Medical Oncology Service, Fundacion Jimenez Diaz, Madrid.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bover', 'Affiliation': 'Medical Oncology Service, Hospital Son Llatzer, Palma de Mallorca.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Medical Oncology Service, Hospital Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Chaib', 'Affiliation': 'Catalan Institute of Oncology, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'You', 'Affiliation': 'Department of Oncology, Suqian General Hospital, Suqian, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Medical Oncology Service, Hospital General de Alicante, Alicante, Spain.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Pneumology, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vergnenegre', 'Affiliation': ""Service de Pathologie Respiratoire et d'Allergologie, CHU Limoges, Limoges, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Pneumology, Taizhou General Hospital, Taizhou, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lopez-Vivanco', 'Affiliation': 'Medical Oncology Service, Hospital de Cruces, Bilbao, Spain.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Robinet', 'Affiliation': 'Service Pneumologie, CHU Brest, Brest, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Medical Oncology Service, Hospital Clinico de Valencia, Valencia, Spain.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Pneumology, Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Medical Oncology Service, Hospital Sant Pau, Barcelona, Spain.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Huaian General Hospital, Huaian, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Las Peñas', 'Affiliation': 'Medical Oncology Service, Hospital Provincial de Castellon, Castellon, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Karachaliou', 'Affiliation': 'Translational Research Unit, Dr Rosell Oncology Institute, Quiron-Dexeus University Hospital, Barcelona.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sala', 'Affiliation': 'Medical Oncology Service, Hospital de Basurto, Bilbao, Spain.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Yixin General Hospital, Yixin, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': 'Medical Oncology Service, Hospital Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Yixin General Hospital, Yixin, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Baize', 'Affiliation': 'Department de Pneumologie, CHU Angers, Angers, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Maanshan General Hospital, Maanshan, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garde', 'Affiliation': 'Medical Oncology Service, Hospital Arnau de Vilanova, Valencia, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Germonpre', 'Affiliation': 'Department of Pulmonary Medicine, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rauh', 'Affiliation': 'Department of Internal Medicine and Oncology, Centre Hospitalier Emile Mayrisch, Luxembourg, Luxembourg.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'ALHusaini', 'Affiliation': 'Oncology Center, King Faisal Cancer Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanchez-Ronco', 'Affiliation': 'Department of Health and Medicosocial Sciences, University of Alcala, Madrid.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drozdowskyj', 'Affiliation': 'DMBS, PIVOTAL SL, Madrid.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sanchez', 'Affiliation': 'Department of Preventive Medicine, Autonomous University of Madrid, Madrid.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Camps', 'Affiliation': 'Medical Oncology Service, Hospital General de Valencia, Valencia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'The Comprehensive Cancer Centre, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Catalan Institute of Oncology, Cancer Biology and Precision Medicine Program, Hospital Germans Trias i Pujol, Badalona; MORe Foundation, Barcelona, Spain; Cancer Therapeutic Innovation Group, New York,USA. Electronic address: rrosell@iconcologia.net.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Colinet', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'De Grève', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Germonpré', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kong', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': ''}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yue', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Baize', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bombaron', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chouaid', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dansin', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fournel', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fraboulet', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gervais', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hominal', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kahlout', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lecaer', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lena', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'LeTreut', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Oliviero', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Robinet', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schoot', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vergnènegre', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berchem', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rauh', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Al Husaini', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Aparisi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Arriola', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ballesteros', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Barneto', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bernabé', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blasco', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bover', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Calvo de Juan', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Camps', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carcereny', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Catot', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'De Las Peñas', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'García-Campelo', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'García-Girón', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'García-Gómez', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garcia-Sevila', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garde', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gasco', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gil', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'González-Larriba', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hernando-Polo', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jantus', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jiménez', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lianes', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'López-López', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'López-Martín', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'López-Vivanco', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Macias', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Marti-Ciriquian', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Montoyo', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Morales-Espinosa', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Morán', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pallares', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Parera', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pérez-Carrión', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Porta', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Reguart', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rosillo', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sala', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Terrasa', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Trigo', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Valdivia', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Viñolas', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Viteri', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Botia-Castillo', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Mate', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Perez-Cano', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Ramirez', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sanchez-Rodriguez', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Taron', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tierno-Garcia', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mijangos', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ocaña', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""O'Brate"", 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu389']
3350,25193990,Adjuvant cisplatin-based chemotherapy in nonsmall-cell lung cancer: new insights into the effect on failure type via a multistate approach.,"BACKGROUND


Adjuvant cisplatin-based chemotherapy has become the standard therapy against resected nonsmall-cell lung cancer (NSCLC). Because of variable results on its late effect, we reanalyze the long-term data of the International Adjuvant Lung Cancer Trial (IALT) to describe in details the role of adjuvant chemotherapy.
PATIENTS AND METHODS


In the IALT, 1867 patients were randomized between adjuvant cisplatin-based chemotherapy and control, who were followed up for a median of 7.5 years. Of these, 1687 patients were enrolled from 132 centers accepting to report the times to cancer events. We used event history methodology to estimate the effects of adjuvant chemotherapy on the risks of local relapse, distant metastasis, and death.
RESULTS


Adjuvant chemotherapy was highly effective against local relapses [HR = 0.73; 95% confidence interval (CI) 0.60-0.90; P = 0.003] and nonbrain metastases (HR = 0.79; 95% CI 0.66-0.94; P = 0.008) but not against brain metastases (HR = 1.1; 95% CI 0.82-1.4; P = 0.61). The effect on noncancer mortality was nonsignificant during the first 5 years (HR = 1.1; 95% CI 0.81-1.5; P = 0.29), whereas the risk of noncancer mortality was subsequently higher with treatment (HR = 3.6; 95% CI 2.2-5.9; P < 0.001). This harmful effect, however, potentially concerned only about 2% of the patients at 8 years.
CONCLUSION


Adjuvant cisplatin-based chemotherapy reduced the risk of local relapse and of nonbrain metastasis, thereby improving survival. This treatment exerted no residual effect on mortality during the first 5 years, but a higher risk of noncancer mortality was found thereafter. Detailed long-term follow-up is strongly recommended for all patients in randomized trials evaluating adjuvant treatments in NSCLC.",2014,"RESULTS


Adjuvant chemotherapy was highly effective against local relapses [HR = 0.73; 95% confidence interval (CI) 0.60-0.90; P = 0.003] and nonbrain metastases (HR = 0.79; 95% CI 0.66-0.94; P = 0.008) but not against brain metastases (HR = 1.1; 95% CI 0.82-1.4; P = 0.61).","['1867 patients were randomized between', '1687 patients were enrolled from 132 centers accepting to report the times to cancer events', 'nonsmall-cell lung cancer']","['adjuvant chemotherapy', 'adjuvant cisplatin-based chemotherapy', 'cisplatin-based chemotherapy', 'Adjuvant cisplatin-based chemotherapy']","['effective against local relapses', 'mortality', 'risks of local relapse, distant metastasis, and death', 'risk of noncancer mortality', 'risk of local relapse and of nonbrain metastasis, thereby improving survival', 'noncancer mortality', 'nonbrain metastases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1867.0,0.279877,"RESULTS


Adjuvant chemotherapy was highly effective against local relapses [HR = 0.73; 95% confidence interval (CI) 0.60-0.90; P = 0.003] and nonbrain metastases (HR = 0.79; 95% CI 0.66-0.94; P = 0.008) but not against brain metastases (HR = 1.1; 95% CI 0.82-1.4; P = 0.61).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rotolo', 'Affiliation': 'Department of Biostatistics and Epidemiology. Electronic address: federico.rotolo@gustaveroussy.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dunant', 'Affiliation': 'Department of Biostatistics and Epidemiology.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Le Chevalier', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Pignon', 'Affiliation': 'Department of Biostatistics and Epidemiology.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Arriagada', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu442']
3351,25210016,Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies.,"BACKGROUND


This report provides a survival update at a follow-up of >5 years (5.5-6 years) for patients with advanced melanoma who previously received ipilimumab in phase II clinical trials. Safety and efficacy data following ipilimumab retreatment are also reported.
PATIENTS AND METHODS


Patients who previously received ipilimumab 0.3, 3, or 10 mg/kg in one of six phase II trials (CA184-004, CA184-007, CA184-008, CA184-022, MDX010-08, and MDX010-15) were eligible to enroll in the companion study, CA184-025. Upon enrollment, patients initially received ipilimumab retreatment, extended maintenance therapy, or were followed for survival only. Overall survival (OS) rates were evaluated in patients from studies CA184-004, CA184-007, CA184-008, and CA184-022. Safety and best overall response during ipilimumab retreatment at 10 mg/kg were assessed in study CA184-025.
RESULTS


Five-year OS rates for previously treated patients who received ipilimumab induction at 0.3, 3, or 10 mg/kg were 12.3%, 12.3%-16.5%, and 15.5%-28.4%, respectively. Five-year OS rates for treatment-naive patients who received ipilimumab induction at 3 or 10 mg/kg were 26.8% and 21.4%-49.5%, respectively. Little to no change in OS was observed from year 5 up to year 6. The objective response rate among retreated patients was 23%. Grade 3/4 immune-related adverse events occurred in 25%, 5.9%, and 13.2% of retreated patients who initially received ipilimumab 0.3, 3, and 10 mg/kg, with the most common being observed in the skin (4.2%, 2.9%, 3.8%) and gastrointestinal tract (12.5%, 2.9%, 3.8%), respectively.
CONCLUSIONS


At a follow-up of 5-6 years, ipilimumab continues to demonstrate durable, long-term survival in a proportion of patients with advanced melanoma. In some patients, ipilimumab retreatment can re-establish disease control with a safety profile that is comparable with that observed during ipilimumab induction. Further studies are needed to determine the contribution of ipilimumab retreatment to OS.
CLINICALTRIALSGOV


NCT00162123.",2014,"Grade 3/4 immune-related adverse events occurred in 25%, 5.9%, and 13.2% of retreated patients who initially received ipilimumab 0.3, 3, and 10 mg/kg, with the most common being observed in the skin (4.2%, 2.9%, 3.8%) and gastrointestinal tract (12.5%, 2.9%, 3.8%), respectively.
","['patients with advanced melanoma', 'Patients who previously received ipilimumab 0.3, 3, or 10 mg/kg in one of six phase II trials (CA184-004, CA184-007, CA184-008, CA184-022, MDX010-08, and MDX010-15) were eligible to enroll in the companion study, CA184-025', 'patients with advanced melanoma who received', 'patients with advanced melanoma who previously received']","['ipilimumab retreatment, extended maintenance therapy', 'ipilimumab']","['objective response rate', 'Safety and efficacy data', 'Survival', 'Grade 3/4 immune-related adverse events', 'OS', 'Overall survival (OS) rates', 'gastrointestinal tract']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1692339', 'cui_str': 'MDX010'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}]",,0.268948,"Grade 3/4 immune-related adverse events occurred in 25%, 5.9%, and 13.2% of retreated patients who initially received ipilimumab 0.3, 3, and 10 mg/kg, with the most common being observed in the skin (4.2%, 2.9%, 3.8%) and gastrointestinal tract (12.5%, 2.9%, 3.8%), respectively.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Department of Dermatology, APHP, CIC, U976 Hôpital Saint-Louis University Paris Diderot, Paris, France. Electronic address: celeste.lebbe@sls.aphp.fr.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Weber', 'Affiliation': 'Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Harmankaya', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Melanoma Therapeutics, Translational Research and Immunotherapy, The Angeles Clinic and Research Institute, Los Angeles.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': ""O'Day"", 'Affiliation': 'Los Angeles Skin Cancer Institute at Beverly Hills Cancer Center, Beverly Hills.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Konto', 'Affiliation': 'Global Clinical Research.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cykowski', 'Affiliation': 'Global Clinical Research.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Global Biometric Sciences, Bristol-Myers Squibb Company, Wallingford.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Ludwig Center for Cancer Immunotherapy, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu441']
3352,22357252,A randomized phase III adjuvant study in high-risk cervical cancer: simultaneous radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R): a NOGGO-AGO Intergroup Study.,"BACKGROUND


Simultaneous adjuvant platinum-based radiochemotherapy in high-risk cervical cancer (CC) is an established treatment strategy. Sequential paclitaxel (Taxol) and platinum followed by radiotherapy may offer further advantages regarding toxicity.
PATIENTS AND METHODS


An open-labeled randomized phase III trial was conducted to compare paclitaxel (175 mg/m(2)) plus carboplatin (AUC5) followed by radiation (50.4 Gy) (experimental arm-A) versus simultaneous radiochemotherapy with cisplatin (40 mg/m(2)/week) (arm-B) in patients with stage IB-IIB CC after surgery. Primary objective was progression-free survival (PFS).
RESULTS


Overall, 271 patients were randomized and 263 were eligible for evaluation; 132 in arm-A and 131 in arm-B appropriately balanced. The estimated 2-year PFS was 81.8% [95% confidence interval (CI) 74.4-89.1] in arm-B versus 87.2% (95% CI 81.2-93.3) in arm-A (P = 0.235) and the corresponding 5-year survival rates were 85.8% in arm-A and 78.9% in arm-B (P = 0.25). Hematological grade 3/4 toxicity was higher in arm-B. Alopecia (87.9% versus 4.1%; P < 0.001) and neurotoxicity (65.9% versus 15.6%; P < 0.001) were significantly higher in arm-A. Early treatment termination was significantly more frequent in arm-B than in arm-A (32.1% versus 12.9%; P = 0.001).
CONCLUSIONS


Sequential chemotherapy and radiation in high-risk CC could not show any significant survival benefit; however, a different toxicity profile appeared. This sequential regime may constitute an alternative option when contraindications for immediate postoperative radiation are present.",2012,"Hematological grade 3/4 toxicity was higher in arm-B. Alopecia (87.9% versus 4.1%; P < 0.001) and neurotoxicity (65.9% versus 15.6%; P < 0.001) were significantly higher in arm-A. Early treatment termination was significantly more frequent in arm-B than in arm-A (32.1% versus 12.9%; P = 0.001).
","['high-risk cervical cancer', 'high-risk cervical cancer (CC', '271 patients were randomized and 263 were eligible for evaluation; 132 in arm-A and 131 in arm-B appropriately balanced', 'patients with stage IB-IIB CC after surgery']","['Sequential paclitaxel ', 'platinum-based radiochemotherapy', 'Taxol) and platinum followed by radiotherapy', 'paclitaxel (175 mg/m(2)) plus carboplatin (AUC5) followed by radiation (50.4 Gy) (experimental arm-A) versus simultaneous radiochemotherapy with cisplatin', 'radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R']","['5-year survival rates', 'neurotoxicity', 'estimated 2-year PFS', 'Alopecia', 'Hematological grade 3/4 toxicity', 'progression-free survival (PFS']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0457152', 'cui_str': 'Stage Ib'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0678133', 'cui_str': 'Taxol'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",271.0,0.123381,"Hematological grade 3/4 toxicity was higher in arm-B. Alopecia (87.9% versus 4.1%; P < 0.001) and neurotoxicity (65.9% versus 15.6%; P < 0.001) were significantly higher in arm-A. Early treatment termination was significantly more frequent in arm-B than in arm-A (32.1% versus 12.9%; P = 0.001).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynecology, European Competence Centre for Ovarian Cancer, Charité-University Hospital, Berlin. Electronic address: sehouli@aol.com.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Runnebaum', 'Affiliation': 'Department of Gynecology, Jena University Hospital, Jena.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fotopoulou', 'Affiliation': 'Department of Gynecology, European Competence Centre for Ovarian Cancer, Charité-University Hospital, Berlin.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Blohmer', 'Affiliation': 'Brustzentrum, Sankt-Gertrauden-Krankenhaus, Berlin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Belau', 'Affiliation': 'Department of Gynecology, Ernst-Moritz-Arndt-Universität Greifswald, Greifswald.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Leber', 'Affiliation': 'Klinik fuer Strahlentherapie, Bruederkrankenhaus St Josef, Paderborn.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Hanker', 'Affiliation': 'Department of Obstetrics and Gynecology, J.W. Goethe-University, Frankfurt.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hartmann', 'Affiliation': 'Department of Gynecology, Klinikum Frankfurt (Oder) GmbH, Frankfurt-Oder.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Richter', 'Affiliation': 'Department of Gynecology, European Competence Centre for Ovarian Cancer, Charité-University Hospital, Berlin.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Keyver-Paik', 'Affiliation': 'Department of Gynecology, Universitätsklinikum Bonn, Bonn.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oberhoff', 'Affiliation': 'Department of Gynecology, Kath. Kliniken Essen-Nord Marienhospital, Altenessen.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Heinrich', 'Affiliation': 'Gyn-oncological Praxis, Fürstenwalde.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology, Horst Schmidt Klinik, Wiesbaden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Olbrich', 'Affiliation': 'Department of Gynecology, DRK Kliniken Berlin Westend, Berlin.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'Department of Gynecology, Kreiskrankenhaus Torgau Johann Kentmann GmbH, Torgau.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Friese', 'Affiliation': 'Department of Gynecology, Universitätsklinik LMU, Munich.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kimmig', 'Affiliation': 'Department of Gynecology, Universitätsklinikum Essen, Essen.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boehmer', 'Affiliation': 'Department of Radiation Oncology, Charite-University Medicine Berlin, Campus Virchow-Klinikum, Berlin.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lichtenegger', 'Affiliation': 'Department of Gynecology, European Competence Centre for Ovarian Cancer, Charité-University Hospital, Berlin.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': 'Brustzentrum, Kliniken Essen-Mitte, Essen, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr628']
3353,25081901,A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.,"BACKGROUND


A germline mutation in the 3'-untranslated region of KRAS (rs61764370, KRAS-variant: TG/GG) has previously been associated with altered patient outcome and drug resistance/sensitivity in various cancers. We examined the prognostic and predictive significance of this variant in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
PATIENTS AND METHODS


We conducted a retrospective study of 103 HNSCCs collected from three completed clinical trials. KRAS-variant genotyping was conducted for these samples and 8 HNSCC cell lines. p16 expression was determined in a subset of 26 oropharynx tumors by immunohistochemistry. Microarray analysis was also utilized to elucidate differentially expressed genes between KRAS-variant and non-variant tumors. Drug sensitivity in cell lines was evaluated to confirm clinical findings.
RESULTS


KRAS-variant status was determined in 95/103 (92%) of the HNSCC tumor samples and the allelic frequency of TG/GG was 32% (30/95). Three of the HNSCC cell lines (3/8) studied had the KRAS-variant. No association between KRAS-variant status and p16 expression was observed in the oropharynx subset (Fisher's exact test, P = 1.0). With respect to patient outcome, patients with the KRAS-variant had poor progression-free survival when treated with cisplatin (log-rank P = 0.002). Conversely, KRAS-variant patients appeared to experience some improvement in disease control when cetuximab was added to their platinum-based regimen (log-rank P = 0.04).
CONCLUSIONS


The TG/GG rs61764370 KRAS-variant is a potential predictive biomarker for poor platinum response in R/M HNSCC patients.
CLINICAL TRIAL REGISTRATION NUMBERS


NCT00503997, NCT00425750, NCT00003809.",2014,"No association between KRAS-variant status and p16 expression was observed in the oropharynx subset (Fisher's exact test, P = 1.0).","['recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC', 'patients with recurrent and/or metastatic head and neck squamous cell carcinoma', '103 HNSCCs collected from three completed clinical trials']",['cisplatin'],"['KRAS-variant status', 'p16 expression', 'KRAS-variant status and p16 expression', 'poor progression-free survival']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0249880', 'cui_str': 'Cyclin-Dependent Kinase Inhibitor p16'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0255991,"No association between KRAS-variant status and p16 expression was observed in the oropharynx subset (Fisher's exact test, P = 1.0).","[{'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'Department of Oncology; Department of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore. Electronic address: cchung11@jhmi.edu.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Slebos', 'Affiliation': 'Department of Cancer Biology.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Howard', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Considine', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Vanderbilt University, Nashville.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Murphy', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Vanderbilt University, Nashville.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nallur', 'Affiliation': 'Department of Therapeutic Radiology.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Paranjape', 'Affiliation': 'Department of Therapeutic Radiology.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Jordan', 'Affiliation': 'Department of Pathology, University of California, San Francisco.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Forastiere', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Weidhaas', 'Affiliation': 'Department of Therapeutic Radiology; Department of Radiation Oncology, University of California, Los Angeles.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu367']
3354,22745214,Sex moderates circadian chemotherapy effects on survival of patients with metastatic colorectal cancer: a meta-analysis.,"BACKGROUND


Molecular circadian clocks can modify cancer chemotherapy effects, with a possible moderation according to sex differences. We investigated whether sex determine the optimal delivery schedule of chemotherapy for metastatic colorectal cancer.
PATIENTS AND METHODS


A meta-analysis was performed using individual data from three international Phase III trials comparing 5-fluorouracil, leucovorin and oxaliplatin administered in chronomodulated (chronoFLO) or conventional (CONV) infusions. The data from 345 females and 497 males were updated at 9 years. The main end point was survival.
RESULTS


Overall survival was improved in males on chronoFLO when compared with CONV (P = 0.009), with respective median values of 20.8 (95% CL, 18.7 to 22.9) and 17.5 months (16.1 to 18.8). Conversely, median survival was 16.6 months (13.9 to 19.3) on chronoFLO and 18.4 months (16.6 to 20.2) on CONV in females (P = 0.012). The sex versus schedule interaction was a strong predictive factor of optimal treatment schedule, with a hazard ratio of 1.59 (1.30 to 1.75) for overall survival (P = 0.002) in multivariate analysis.
CONCLUSIONS


Males lived significantly longer on chronomodulated chemotherapy rather than on conventional chemotherapy. The current chronoFLO schedule deserves prospective assessment as a safe and more effective first-line treatment option than conventional delivery for male patients.",2012,"RESULTS


Overall survival was improved in males on chronoFLO when compared with CONV (P = 0.009), with respective median values of 20.8 (95% CL, 18.7 to 22.9) and 17.5 months (16.1 to 18.8).","['male patients', 'patients with metastatic colorectal cancer', '345 females and 497 males were updated at 9 years', 'metastatic colorectal cancer']","['Sex moderates circadian chemotherapy', '5-fluorouracil, leucovorin and oxaliplatin administered in chronomodulated (chronoFLO) or conventional (CONV) infusions', 'conventional chemotherapy', 'chemotherapy']","['Overall survival', 'survival', 'median survival', 'overall survival']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.116164,"RESULTS


Overall survival was improved in males on chronoFLO when compared with CONV (P = 0.009), with respective median values of 20.8 (95% CL, 18.7 to 22.9) and 17.5 months (16.1 to 18.8).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Giacchetti', 'Affiliation': ""INSERM, UMRS776 'Biological Rhythms and Cancers', Villejuif; Paris South University, UMR-S0776, Orsay; APHP, Chronotherapy Unit, Department of Oncology, Paul Brousse hospital, Villejuif; Faculty of Medicine, Paris XI University, le Kremlin-Bicêtre, France.""}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Dugué', 'Affiliation': ""INSERM, UMRS776 'Biological Rhythms and Cancers', Villejuif; Paris South University, UMR-S0776, Orsay; APHP, Chronotherapy Unit, Department of Oncology, Paul Brousse hospital, Villejuif; Faculty of Medicine, Paris XI University, le Kremlin-Bicêtre, France.""}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Innominato', 'Affiliation': ""INSERM, UMRS776 'Biological Rhythms and Cancers', Villejuif; Paris South University, UMR-S0776, Orsay; APHP, Chronotherapy Unit, Department of Oncology, Paul Brousse hospital, Villejuif; Faculty of Medicine, Paris XI University, le Kremlin-Bicêtre, France.""}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Bjarnason', 'Affiliation': 'Division of Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Focan', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Chrétien, Clinique Saint-Joseph, Liège, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garufi', 'Affiliation': 'Department of Medical Oncology C, Istituto Regina Elena, Roma.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tumolo', 'Affiliation': 'Department of Medical Oncology, Azienda Ospedaliera Santa Maria Degli Angeli, Pordenone, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Coudert', 'Affiliation': 'Department of Medical Oncology, Georges-François Leclerc Center, Dijon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Iacobelli', 'Affiliation': ""Department of Medical Oncology, G. D'Annunzio di Chieti University, Chieti, Italy.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Smaaland', 'Affiliation': 'Department of Hematology and Oncology, Stavanger University Hospital, Stavanger; University of Bergen, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tampellini', 'Affiliation': 'Department of Medical and Biological Sciences, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': ""INSERM, UMRS776 'Biological Rhythms and Cancers', Villejuif; Paris South University, UMR-S0776, Orsay; APHP, Chronotherapy Unit, Department of Oncology, Paul Brousse hospital, Villejuif; Faculty of Medicine, Paris XI University, le Kremlin-Bicêtre, France; Onco-surgery Unit, Hepato-biliary Center, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moreau', 'Affiliation': 'Department of Biostatistics, INSERM U1018, Paul Brousse Hospital, Villejuif, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lévi', 'Affiliation': ""INSERM, UMRS776 'Biological Rhythms and Cancers', Villejuif; Paris South University, UMR-S0776, Orsay; APHP, Chronotherapy Unit, Department of Oncology, Paul Brousse hospital, Villejuif; Faculty of Medicine, Paris XI University, le Kremlin-Bicêtre, France. Electronic address: monique.levi@inserm.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds148']
3355,22767584,"Persistence, adherence, and toxicity with oral CMF in older women with early-stage breast cancer (Adherence Companion Study 60104 for CALGB 49907).","BACKGROUND


Cyclophosphamide-methotrexate-5-fluorouracil (CMF) is often selected as adjuvant chemotherapy for older patients with early-stage breast cancer due to perceived superior tolerability. We sought to measure persistence with CMF, adherence to oral cyclophosphamide, and the association of these with toxic effects.
PATIENTS AND METHODS


CALGB 49907 was a randomized trial comparing standard chemotherapy (CMF or AC, provider/patient choice) with capecitabine in patients aged ≥65 with stage I-IIIB breast cancer. Those randomized to standard therapy and choosing CMF were prescribed oral cyclophosphamide 100 mg/m(2) for 14 consecutive days in six 28-day cycles. Persistence was defined as being prescribed six cycles of at least one of the three CMF drugs. Adherence was the number of cyclophosphamide doses that women reported they had taken divided by the number prescribed. Persistence and adherence were based on case report forms and medication calendars.
RESULTS


Of 317 randomized to standard chemotherapy, 133 received CMF. Median age was 73 (range 65-88). Seventy-one percent submitted at least one medication calendar; 65% persisted with CMF. Non-persistence was associated with node negativity (P = 0.019), febrile neutropenia (P = 0.002), and fatigue (P = 0.044). Average adherence was 97% during prescribed cycles.
CONCLUSIONS


Self-reported adherence to cyclophosphamide was high, but persistence was lower, which may be attributable to toxic effects.",2012,"Non-persistence was associated with node negativity (P = 0.019), febrile neutropenia (P = 0.002), and fatigue (P = 0.044).","['Median age was 73 (range 65-88', 'patients aged ≥65 with stage I-IIIB breast cancer', 'CALGB 49907', 'older women with early-stage breast cancer (Adherence Companion Study 60104 for CALGB 49907', 'older patients with early-stage breast cancer']","['standard chemotherapy (CMF or AC, provider/patient choice) with capecitabine', 'cyclophosphamide', 'CMF', 'Cyclophosphamide-methotrexate-5-fluorouracil (CMF', 'standard chemotherapy', 'oral CMF']","['Persistence and adherence', 'Persistence, adherence, and toxicity', 'febrile neutropenia', 'Average adherence', 'node negativity', 'fatigue']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.106602,"Non-persistence was associated with node negativity (P = 0.019), febrile neutropenia (P = 0.002), and fatigue (P = 0.044).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston. Electronic address: kruddy@partners.org.'}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': 'CALGB Statistical Center, Duke University Medical Center, Durham.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Archer', 'Affiliation': 'CALGB Statistical Center, Duke University Medical Center, Durham.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'CALGB Statistical Center, Duke University Medical Center, Durham.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Medical Oncology, Memorial Sloan Kettering Cancer Center, New York.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'Medical Oncology, University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds133']
3356,32017688,A 12-month feasibility study to investigate the effectiveness of cryogen-cooled monopolar radiofrequency treatment for female stress urinary incontinence.,"INTRODUCTION


The purpose of this early feasibility study was to evaluate the safety and efficacy of a non-ablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment for female stress urinary incontinence (SUI).
METHODS


Subjects meeting all the inclusion and exclusion criteria were enrolled and randomized into two groups. Subjects in group 1 received one CMRF treatment and subjects in group 2 received two CMRF treatments six weeks apart. Followup visits were performed at one, four, six, and 12 months post-treatment. At each study visit, subjects performed an objective, standardized one-hour pad weight test and completed several patient-reported outcome measures, a seven-day bladder voiding diary, and safety assessments.
RESULTS


Data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective one-hour pad weight test, with a >50% reduction in pad weight from baseline for 52% of the subjects at 12 months. In addition to efficacy, the CMRF treatment was well-tolerated and safe.
CONCLUSIONS


The outcome measures evaluated indicate an improvement in SUI symptoms and quality of life. The sustained benefit of the CMRF vaginal treatment at 12 months suggests potential use as an office-based, non-surgical approach to treat mild to moderate SUI.",2020,"RESULTS


Data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective one-hour pad weight test, with a >50% reduction in pad weight from baseline for 52% of the subjects at 12 months.","['Subjects meeting all the inclusion and exclusion criteria', 'female stress urinary incontinence (SUI', 'female stress urinary incontinence']","['cryogen-cooled monopolar radiofrequency treatment', 'CMRF', 'CMRF vaginal treatment', 'non-ablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment', 'CMRF treatment']","['seven-day bladder voiding diary, and safety assessments', 'pad weight', 'safety and efficacy', 'tolerated and safe', 'SUI symptoms and quality of life']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.0328095,"RESULTS


Data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective one-hour pad weight test, with a >50% reduction in pad weight from baseline for 52% of the subjects at 12 months.","[{'ForeName': 'Bruce B', 'Initials': 'BB', 'LastName': 'Allan', 'Affiliation': 'Allan Centre, Calgary, AB, Canada.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Viveve Inc., United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Husarek', 'Affiliation': 'Viveve Inc., United States.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6145']
3357,32017693,"A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.","INTRODUCTION


We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients.
METHODS


We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant.
RESULTS


We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups.
CONCLUSIONS


TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.",2020,"CONCLUSIONS


TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.","['50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group', 'people with OAB or neurogenic bladder dysfunction', 'overactive bladder and neurogenic bladder patients', 'Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms', 'overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients']","['transcutaneous tibial nerve stimulation', 'transcutaneous tibial nerve stimulation (TTNS', 'TTNS']","['marginal mean of the end-of-study PPBC score', 'patient perception of bladder condition (PPBC', 'PPBC', 'secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic Bladder'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.480228,"CONCLUSIONS


TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.","[{'ForeName': 'Blayne', 'Initials': 'B', 'LastName': 'Welk', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McKibbon', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6142']
3358,24718885,Chronicle: results of a randomised phase III trial in locally advanced rectal cancer after neoadjuvant chemoradiation randomising postoperative adjuvant capecitabine plus oxaliplatin (XELOX) versus control.,"BACKGROUND


In stage III colon cancer, oxaliplatin/5-fluorouracil (5-FU)-based adjuvant chemotherapy (FOLFOX) improves disease-free survival (DFS) and overall survival (OS). In rectal adenocarcinoma following neoadjuvant chemoradiation (CRT), we examined the benefit of postoperative adjuvant capecitabine and oxaliplatin (XELOX) chemotherapy.
METHODS


Eligible patients were randomly assigned following fluoropyrimidine-based CRT and curative resection to observation or six cycles of XELOX. The primary end point was DFS; secondary end points were acute toxicity and OS. 390 patients were required in each arm, to detect an improvement in 3-year DFS from 40% to 50.5%, with 85% power and two-sided 5% significance level.
RESULTS


The study closed prematurely in 2008 because of poor accrual. Only 113 patients were randomly assigned to either observation (n = 59) or XELOX (n = 54). Compliance was poor, 93% allocated chemotherapy started and 48% completed six cycles. Protocolised dose reductions in XELOX were 39%, and levels of G3/G4 toxicity 40%. After a median follow-up of 44.8 months, 16 patients (27%) in the observation arm had relapsed or died compared with 12 patients (22%) in XELOX. The 3-year DFS rate was 78% with XELOX and 71% with observation [hazard ratio (HR) for DFS = 0.80; 95% confidence interval (CI) 0.38-1.69; P = 0.56]. The 3-year OS for XELOX and observation were 89% and 88%, respectively (HR for OS = 1.18; 95% CI 0.43-3.26; P = 0.75).
CONCLUSIONS


The observed improvement in DFS for adjuvant XELOX and similar OS were not statistically significant, as expected given the small number of patients and consequent low power. Our findings support the need for trials that test the role of neoadjuvant chemotherapy.
CLINICALTRIALSGOV IDENTIFIER


NCT00427713.",2014,"The 3-year OS for XELOX and observation were 89% and 88%, respectively","['390 patients', '113 patients', 'Eligible patients', 'locally advanced rectal cancer after neoadjuvant chemoradiation randomising postoperative adjuvant']","['oxaliplatin/5-fluorouracil (5-FU)-based adjuvant chemotherapy (FOLFOX', 'postoperative adjuvant capecitabine and oxaliplatin (XELOX) chemotherapy', 'XELOX', 'neoadjuvant chemoradiation (CRT', 'capecitabine plus oxaliplatin (XELOX', 'fluoropyrimidine-based CRT and curative resection to observation or six cycles of XELOX']","['DFS for adjuvant XELOX and similar OS', 'relapsed or died', 'disease-free survival (DFS) and overall survival (OS', '3-year DFS', '3-year DFS rate', '3-year OS for XELOX and observation', 'acute toxicity and OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.205664,"The 3-year OS for XELOX and observation were 89% and 88%, respectively","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Centre for Cancer Treatment, London. Electronic address: rob.glynnejones@nhs.net.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Counsell', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': 'Leeds Institute of Molecular Medicine, University of Leeds, Leeds.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mortensen', 'Affiliation': 'Department of Colorectal Surgery, University of Oxford, Oxford.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maraveyas', 'Affiliation': ""Queen's Centre for Oncology and Haematology, Castle Hill Hospital, Hull, UK.""}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Meadows', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ledermann', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'Leeds Institute of Molecular Medicine, University of Leeds, Leeds.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu147']
3359,24718886,Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer.,"BACKGROUND


The Panitumumab Randomized trial In combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy (PRIME) demonstrated that panitumumab-FOLFOX4 significantly improved progression-free survival (PFS) versus FOLFOX4 as first-line treatment of wild-type (WT) KRAS metastatic colorectal cancer (mCRC), the primary end point of the study.
PATIENTS AND METHODS


Patients were randomized 1:1 to panitumumab 6.0 mg/kg every 2 weeks + FOLFOX4 (arm 1) or FOLFOX4 (arm 2). This prespecified final descriptive analysis of efficacy and safety was planned for 30 months after the last patient was enrolled.
RESULTS


A total of 1183 patients were randomized. Median PFS for WT KRAS mCRC was 10.0 months [95% confidence interval (CI) 9.3-11.4 months] for arm 1 and 8.6 months (95% CI 7.5-9.5 months) for arm 2; hazard ratio (HR) = 0.80; 95% CI 0.67-0.95; P = 0.01. Median overall survival (OS) for WT KRAS mCRC was 23.9 months (95% CI 20.3-27.7 months) for arm 1 and 19.7 months (95% CI 17.6-22.7 months) for arm 2; HR = 0.88; 95% CI 0.73-1.06; P = 0.17 (68% OS events). An exploratory analysis of updated survival (>80% OS events) was carried out which demonstrated improvement in OS; HR = 0.83; 95% CI 0.70-0.98; P = 0.03 for WT KRAS mCRC. The adverse event profile was consistent with the primary analysis.
CONCLUSIONS


In WT KRAS mCRC, PFS was improved, objective response was higher, and there was a trend toward improved OS with panitumumab-FOLFOX4, with significant improvement in OS observed in an updated analysis of survival in patients with WT KRAS mCRC treated with panitumumab + FOLFOX4 versus FOLFOX4 alone (P = 0.03). These data support a positive benefit-risk profile for panitumumab-FOLFOX4 for patients with previously untreated WT KRAS mCRC. KRAS testing is critical to select appropriate patients for treatment with panitumumab.",2014,"In WT KRAS mCRC, PFS was improved, objective response was higher, and there was a trend toward improved OS with panitumumab-FOLFOX4, with significant improvement in OS observed in an updated analysis of survival in patients with WT KRAS mCRC treated with panitumumab + FOLFOX4 versus FOLFOX4 alone (P = 0.03).","['Metastatic colorectal cancer', 'Patients', 'patients with previously untreated WT KRAS mCRC', '1183 patients were randomized', 'metastatic colorectal cancer']","['panitumumab 6.0 mg/kg every 2 weeks + FOLFOX4 (arm 1) or FOLFOX4', 'panitumumab', 'panitumumab with FOLFOX4', 'panitumumab + FOLFOX4', 'chemotherapy', 'panitumumab-FOLFOX4']","['Median overall survival (OS) for WT KRAS mCRC', 'efficacy and safety', 'objective response', 'OS', 'adverse event profile', 'Median PFS for WT KRAS mCRC', 'progression-free survival (PFS', 'updated survival']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1183.0,0.268267,"In WT KRAS mCRC, PFS was improved, objective response was higher, and there was a trend toward improved OS with panitumumab-FOLFOX4, with significant improvement in OS observed in an updated analysis of survival in patients with WT KRAS mCRC treated with panitumumab + FOLFOX4 versus FOLFOX4 alone (P = 0.03).","[{'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Douillard', 'Affiliation': 'Department of Medical Oncology, Centre René Gauducheau, Nantes, France. Electronic address: jean-yves.douillard@ico.unicancer.fr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siena', 'Affiliation': ""Division of Medical Oncology, Ospedale Niguarda Ca' Granda, Milan, Italy.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'Division of Cancer Sciences and Molecular Pathology, The Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burkes', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Mount Sinai Hospital, Toronto, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barugel', 'Affiliation': 'Department of Medical Oncology, Hospital de Gastroenterología, Buenos Aires, Argentina.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Humblet', 'Affiliation': 'Department of Medical Oncology, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bodoky', 'Affiliation': 'Department of Oncology, Szent Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kocákova', 'Affiliation': 'Oncology Department, Masarykuv Onkologicky Ustav, Brno, Czech Republic.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ruff', 'Affiliation': 'Department of Medical Oncology, University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Błasińska-Morawiec', 'Affiliation': 'Proliferative Diseases Branch, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Šmakal', 'Affiliation': 'Department of Oncology, Institut Onkologie a Rehabilitace na Plesi s.r.o., Nová Ves pod Pleší, Czech Republic.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Canon', 'Affiliation': 'Department of Oncology and Hematology, Grand Hôpital de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rother', 'Affiliation': 'Department of Oncology, The Credit Valley Hospital, Mississauga,Canada.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Oliner', 'Affiliation': 'Department of Medical Sciences, Amgen, Inc., Thousand Oaks.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, Amgen, Inc., Thousand Oaks.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Biostatistics, Amgen, Inc., Thousand Oaks.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sidhu', 'Affiliation': 'Department of Global Development, Amgen, Inc., Thousand Oaks, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu141']
3360,24723487,Randomized phase II trial of irinotecan and bevacizumab as neo-adjuvant and adjuvant to temozolomide-based chemoradiation compared with temozolomide-chemoradiation for unresectable glioblastoma: final results of the TEMAVIR study from ANOCEF†.,"BACKGROUND


Prognosis of unresectable glioblastoma (GB) remains poor, despite temozolomide (TMZ)-based chemoradiation. Activity of bevacizumab (BEV) and irinotecan (IRI) has been reported in recurrent disease. We evaluated BEV and IRI as neo-adjuvant and adjuvant treatment combined with TMZ-based chemoradiation for unresectable GB.
PATIENTS AND METHODS


Patients with unresectable GB, age 18-70, IK ≥50 were eligible. The experimental arm (BEV/IRI) consisted of neo-adjuvant intravenous BEV, 10 mg/kg, and IRI, 125 mg/m(2), every 2 weeks for four cycles before radiotherapy (RT) (60 Gy), concomitant oral TMZ, 75 mg/m(2)/day, and BEV, 10 mg/kg every 2 weeks. Adjuvant BEV and IRI were given every 2 weeks for 6 months. The control arm consisted of concomitant oral TMZ, 75 mg/m(2)/day during RT, and 150-200 mg/m(2) for 5 days every 28 days for 6 months. The use of BEV was allowed at progression in the control arm.
RESULTS


Patients (120) were included from April 2009 to January 2011. The working hypothesis was that treatment would increase the progression-free survival at 6 month (PFS-6) from 50% to 66%. The primary objective was not achieved, and only 30 out of 60 patients were alive without progression at 6 months (50.0% [IC95% (36.8; 63.1)] in the BEV/IRI arm when 37 out of 60 patients were required according to the Fleming decision rules. PFS-6 was 7.1 months in BEV/IRI versus 5.2 months in the control arm. The median overall survival was not different between the two arms (11.1 months). Main toxicities were three fatal intracranial bleedings, three bile duct or digestive perforations/infections (1 fatal), and six thrombotic episodes in the BEV/IRI arm, whereas there was one intracranial bleeding, two bile duct or digestive perforations/infections (1 fatal), and one thrombotic episode in the control arm.
CONCLUSIONS


Neo-adjuvant and adjuvant BEV/IRI, combined with TMZ-radiation, is not recommended for further evaluation in the first-line treatment of unresectable GB.
CLINICAL TRIAL REGISTRATION


Clinical trial registered under EUDRACT number 2008-002775-28 (NCT01022918).",2014,PFS-6 was 7.1 months in BEV/IRI versus 5.2 months in the control arm.,"['Patients (120) were included from April 2009 to January 2011', 'Patients with unresectable GB, age 18-70, IK ≥50 were eligible', 'unresectable glioblastoma']","['irinotecan and bevacizumab', 'TMZ-based chemoradiation', 'TMZ-radiation', 'bevacizumab (BEV) and irinotecan (IRI', 'radiotherapy (RT) (60 Gy), concomitant oral TMZ', 'temozolomide-chemoradiation', 'concomitant oral TMZ', 'temozolomide-based chemoradiation', 'temozolomide (TMZ)-based chemoradiation']","['median overall survival', 'alive without progression', 'PFS-6', 'Main toxicities', 'progression-free survival', 'fatal intracranial bleedings, three bile duct or digestive perforations/infections (1 fatal), and six thrombotic episodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0005400', 'cui_str': 'Bile Ducts'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",60.0,0.0619152,PFS-6 was 7.1 months in BEV/IRI versus 5.2 months in the control arm.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': 'Department of Medical Oncology, University Hospital, EA 4666, Amiens. Electronic address: chauffert.bruno@chu-amiens.fr.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Feuvret', 'Affiliation': 'Department of Radiotherapy, Pitie-Salpetriere University Hospital, Paris.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Methodology and Quality of Life Unit, Department of Oncology, EA 3181, University Hospital, Besancon.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Taillandier', 'Affiliation': 'Department of Neurology, University Hospital, Nancy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Frappaz', 'Affiliation': 'Department of Oncology, Leon Berard Centre for Fight against Cancer, Lyon.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Taillia', 'Affiliation': 'Department of Neurology, HIA Val de Grace, Paris.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schott', 'Affiliation': 'Department of Oncology, Paul Strauss Centre for Fight against Cancer, Strasbourg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Honnorat', 'Affiliation': 'Department of Neurology, University Hospital, Lyon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fabbro', 'Affiliation': ""Department of Oncology, Val d'Aurelle Center for Fight against Cancer, Montpellier.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tennevet', 'Affiliation': 'Department of Oncology, Henri Becquerel Center for Fight against Cancer, Rouen.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': 'Department of Oncology, GF Leclerc Center for Fight against Cancer, Dijon.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Guillamo', 'Affiliation': 'Department of Neurology, University Hospital, Caen.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Durando', 'Affiliation': 'Department of Oncology, Jean Perrin Center for Fight against Cancer, Clermont-Ferrand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Castera', 'Affiliation': 'Clinique Saint Pierre, Perpignan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frenay', 'Affiliation': 'Department of Oncology, Antoine Lacassagne Center for Fight against Cancer, Nice.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Campello', 'Affiliation': 'Department of Neurology, University Hospital, Nimes.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dalban', 'Affiliation': 'Methodology Unit, GF Leclerc Center for Fight against Cancer, Dijon.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Skrzypski', 'Affiliation': 'Methodology Unit, GF Leclerc Center for Fight against Cancer, Dijon.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Department of Neuro-Oncology, University Hospital La Timone, Marseille, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu148']
3361,24728035,Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer.,"BACKGROUND


Some trial have demonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared with surgery alone. ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI [irinotecan plus 5-fluorouracil/folinic acid (5-FU/LV)] followed by docetaxel plus cisplatin improves disease-free survival in comparison with 5-FU/LV in patients with radically resected gastric cancer.
PATIENTS AND METHODS


Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m(2) day 1, LV 100 mg/m(2) as 2 h infusion and 5-FU 400 mg/m(2) as bolus, days 1 and 2 followed by 600 mg/m(2)/day as 22 h continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m(2) day 1, cisplatin 75 mg/m(2) day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm).
RESULTS


From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis: 562 in the sequential arm and 538 in the 5-FU/LV arm. With a median follow-up of 57.4 months, 581 patients recurred or died (297 sequential arm and 284 5-FU/LV arm), and 483 died (243 and 240, respectively). No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85-1.17; P = 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82-1.18; P = 0.865). Five-year disease-free and OS rates were 44.6% and 44.6%, 51.0% and 50.6% in the sequential and 5-FU/LV arm, respectively.
CONCLUSIONS


A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01640782.",2014,No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85-1.17; P = 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82-1.18; P = 0.865).,"['patients with radically resected gastric cancer', 'From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis', 'radically resected gastric cancer', 'Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction']","['ITACA', 'fluoropirimidine', 'docetaxel 75 mg/m(2) day 1, cisplatin 75 mg/m(2) day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm', 'docetaxel plus cisplatin', '5-FU/LV', 'FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid', 'FOLFIRI (irinotecan 180 mg/m(2) day 1, LV 100 mg/m(2) as 2 h infusion and 5-FU', 'FOLFIRI [irinotecan plus 5-fluorouracil/folinic acid (5-FU/LV']","['disease-free survival', 'overall survival (OS', 'OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1106.0,0.287689,No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85-1.17; P = 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82-1.18; P = 0.865).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bajetta', 'Affiliation': 'Istituto di Oncologia, Policlinico di Monza, Monza.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Floriani', 'Affiliation': ""Laboratory of Clinical Research, IRCCS-Istituto di Ricerche Farmacologiche 'Mario Negri', Milano. Electronic address: irene.floriani@marionegri.it.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Struttura Complessa di Medicina Oncologica 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Unità di Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Dipartimento di Ricerca Traslazionale, Università di Pisa, Istituto Toscano Tumori, Pisa.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Di Costanzo', 'Affiliation': 'S.C. Oncologia Medica, Azienda Ospedaliero-Universitaria Careggi, Firenze.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Comella', 'Affiliation': 'Oncologia Medica A, Fondazione Pascale, Istituto Nazionale dei Tumori, Napoli.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Amadori', 'Affiliation': 'I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pinto', 'Affiliation': 'U.O. di Oncologia Medica, Policlinico S.Orsola Malpighi, Bologna.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carlomagno', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Università Federico II, Napoli.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nitti', 'Affiliation': 'Clinica Chiurgica 1, Dipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche, Padova.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Dipartimento di Oncologia, A.O.G. Rummo, Benevento.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mini', 'Affiliation': 'Dipartimento di Scienze Della Salute, Sezione di Farmacologia Clinica e Oncologia, Università degli Studi di Firenze, Firenze.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': ""Laboratory of Clinical Research, IRCCS-Istituto di Ricerche Farmacologiche 'Mario Negri', Milano.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'U.O. Oncologia e Ematologia, Humanitas Cancer Center, Istituto Clinico Humanitas-I.R.C.C.S., Rozzano.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mosconi', 'Affiliation': 'Unità di Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Casaretti', 'Affiliation': ""S.C. di Oncologia Medica Addominale, dell'Istituto Tumori di Napoli, Napoli.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boni', 'Affiliation': 'Oncologia, Arcispedale Santa Maria Nuova-I.R.C.C.S., Reggio Emilia, Reggio Emilia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pinotti', 'Affiliation': 'Divisione di Oncologia Medica, A.O. Ospedale di Circolo, Varese.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bidoli', 'Affiliation': 'S.C. Oncologia Medica, A.O.S. Gerardo, Monza.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Landi', 'Affiliation': 'U.O. Oncologia Medica, Azienda USL6 di Livorno, Istituto Toscano Tumori, Livorno.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Unità Oncologia Medica, Ospedale S. Carlo, Potenza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ravaioli', 'Affiliation': 'U.O. di Oncologia, Ospedale Infermi Rimini, Ospedale Cervesi, Azienda USL di Rimini, Rimini, Cattolica.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cantore', 'Affiliation': 'Oncologia Medica, USL 1, Massa Carrara.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Di Fabio', 'Affiliation': 'U.O. di Oncologia Medica, Policlinico S.Orsola Malpighi, Bologna.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aitini', 'Affiliation': 'Ospedale Carlo Poma, Mantova, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchet', 'Affiliation': 'Clinica Chiurgica 1, Dipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche, Padova.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu146']
3362,31953863,"Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder.","OBJECTIVE


To evaluate the dose-response relationship of daridorexant, a new dual orexin receptor antagonist, on sleep variables in subjects with insomnia disorder.
METHODS


Adults (≤64 years) with insomnia disorder were randomized (1:1:1:1:1:1) to receive daily oral placebo, daridorexant (5, 10, 25, or 50mg), or 10mg zolpidem for 30 days. The primary efficacy outcome was the change in wake time after sleep onset from baseline to days 1 and 2. Secondary outcome measures were change in latency to persistent sleep from baseline to days 1 and 2, change in subjective wake time after sleep onset, and subjective latency to sleep onset from baseline to week 4. Safety was also assessed.
RESULTS


Of 1,005 subjects screened, 359 (64% female) were randomized and received ≥1 dose. A significant dose-response relationship (multiple comparison procedure-modeling, 2-sided p < 0.001) was found in the reduction of wake after sleep onset and latency to persistent sleep from baseline to days 1 and 2 with daridorexant. These reductions were sustained through to days 28 and 29 (p = 0.050 and p = 0.042, respectively). Similar dose-dependent relationships were observed for subjective wake after sleep onset and subjective latency to sleep onset. The incidence of treatment-emergent adverse events was 35%, 38%, 38%, and 34% in subjects treated with 5, 10, 25, and 50mg daridorexant, respectively, compared with 30% for placebo, and 40% for 10mg zolpidem. There were no clinically relevant treatment-related serious adverse events. Four subjects withdrew due to adverse events.
INTERPRETATION


Daridorexant induced a dose-dependent reduction in wake time after sleep onset in subjects with insomnia disorder (Clinicaltrials.gov NCT02839200). Ann Neurol 2020;87:347-356.",2020,"These reductions were sustained through to Days 28&29 (p=0.050 and p=0.042, respectively).","['Adults (≤64\u2009years) with insomnia disorder', 'subjects with insomnia disorder', 'Of 1005 subjects screened, 359 (64% female']","['placebo', 'zolpidem', 'daily oral placebo, daridorexant', 'daridorexant']","['change in wake time after sleep onset', 'subjective wake after sleep onset and subjective latency to sleep onset', 'reduction of wake after sleep onset and latency to persistent sleep', 'incidence of treatment-emergent adverse events', 'change in latency to persistent sleep from baseline to Days 1&2, change in subjective wake time after sleep onset and subjective latency to sleep onset', 'Safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1005.0,0.217756,"These reductions were sustained through to Days 28&29 (p=0.050 and p=0.042, respectively).","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Sleep Unit, Department of Neurology, Neuropsychiatry: Epidemiological and Clinical Research, University of Montpellier, National Institute of Health and Medical Research, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation and Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Fietze', 'Affiliation': 'Center of Interdisciplinary Sleep Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'CTI Clinical Research Center, Cincinnati, OH.'}, {'ForeName': 'Dalma', 'Initials': 'D', 'LastName': 'Seboek Kinter', 'Affiliation': 'Clinical Development, Idorsia Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pain', 'Affiliation': 'Clinical Development, Idorsia Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}]",Annals of neurology,['10.1002/ana.25680']
3363,32019278,PIK3CA H1047R Mutation Associated with a Lower Pathological Complete Response Rate in Triple-Negative Breast Cancer Patients Treated with Anthracycline-Taxane-Based Neoadjuvant Chemotherapy.,"PURPOSE


PIK3CA, encoding for subunit p110a of phosphatidylinositol 3 kinase, is frequently mutated in breast cancer. PIK3CA mutation was predictive for pathological complete response (pCR) in human epidermal growth factor 2 positive breast cancer. This study explores the association of PIK3CA mutation and pCR in triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy.
Materials and Methods


A total of 92 patients with TNBC derived from a prospectively randomized phase II trial GeparSixto study (NCT01426880). Exon 9 and exon 20 of PIK3CA mutations were evaluated by using classical Sanger method with formalin-fixed paraffin-embedded tumor tissues.
RESULTS


Seven of 90 tumors (7.8%) were detectable with a PIK3CA H1047R mutation. Overall, PIK3CA H1047R mutation was significantly associated with a lower pCR rate (14.3% vs. 56.6%; odds ratio, 0.128; 95% confidence interval [CI], 0.015 to 1.108; p=0.047). In carboplatin- containing treatment patients, H1047R mutation trended to predict a lower pCR rate (20% vs. 62.5%; p=0.146). In a multivariable analysis, H1047R mutation trended to predict a lower pCR rate (hazard ratio, 0.1; 95% CI, 0.01 to 1; p=0.056).
CONCLUSION


TNBC with a PIK3CA H1047R mutation was less likely to achieve pCR after anthracycline-based neoadjuvant chemotherapy. Development of H1047R mutant selective inhibitors might be helpful to conquer this subtype of breast cancer.",2020,"Overall, PIK3CA H1047R mutation was significantly associated with a lower pCR rate (14.3% vs. 56.6%; odds ratio [OR], 0.128; 95% confidence interval [CI], 0.015 to 1.108; p=0.047).","['92 patients with TNBC', 'Triple-Negative Breast Cancer Patients Treated with']","['Anthracycline-Taxane-Based Neoadjuvant Chemotherapy', 'PIK3CA mutation and pCR', 'anthracycline-based neoadjuvant chemotherapy', 'neoadjuvant chemotherapy']",['pCR rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",92.0,0.0339473,"Overall, PIK3CA H1047R mutation was significantly associated with a lower pCR rate (14.3% vs. 56.6%; odds ratio [OR], 0.128; 95% confidence interval [CI], 0.015 to 1.108; p=0.047).","[{'ForeName': 'Sanxing', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Darb-Esfahani', 'Affiliation': 'Institute of Pathology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Lederer', 'Affiliation': 'German Breast Group, Neu-Isenburg, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Pathology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Cancer research and treatment : official journal of Korean Cancer Association,['10.4143/crt.2019.497']
3364,24769640,Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine.,"BACKGROUND


In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P < 0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial.
METHODS


The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits.
RESULTS


For DTIC, all functional dimensions except role dimension worsened from baseline at follow-up. For dabrafenib, all functionality dimensions remained stable relative to baseline or improved at week 6; mean change in seven symptom dimensions improved from baseline, with appetite loss, insomnia, nausea and vomiting, and pain showing the greatest improvement. In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting. Mixed-model-repeated measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements from baseline in favor of dabrafenib for emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia at weeks 6 and/or 12. After crossing over to dabrafenib upon progression (n = 35), improvements in all QoL dimensions were evident after receiving dabrafenib for 6 (n = 31) to 12 (n = 25) weeks.
CONCLUSIONS


This first reported QoL analysis for a BRAF inhibitor in metastatic melanoma demonstrates that the high tumor response rates and PFS superiority of dabrafenib over DTIC is not only a theoretical advantage, but also transforms in a rapid functional and symptomatic benefit for the patient. ClinicalTrials.gov Identifier: NCT01227889.",2014,"In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting.","['patients with BRAF V600E metastatic melanoma', 'metastatic melanoma']","['BRAF inhibitor', 'dacarbazine (DTIC', 'dacarbazine']","['prolonged progression-free survival (PFS', 'fatigue and nausea and vomiting', 'EORTC QLQ-C30 questionnaire assessed quality of life (QoL', 'symptom dimensions', 'QoL dimensions', 'emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia', 'appetite loss, insomnia, nausea and vomiting, and pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C4521853', 'cui_str': 'B-Raf inhibitor'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.527626,"In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting.","[{'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix-Marseille University, APHM, Hôpital Timone, Marseille, France. Electronic address: jean-jacques.grob@ap-hm.fr.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Amonkar', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Martin-Algarra', 'Affiliation': 'Department of Medical Oncology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Demidov', 'Affiliation': 'Department of Tumor Biotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Goodman', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Grotzinger', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Haney', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kämpgen', 'Affiliation': 'Department of Dermatology, Skin Cancer Center, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Karaszewska', 'Affiliation': 'Przychodnia Lekarska KOMED, Konin, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mauch', 'Affiliation': 'Department for Dermatology and Venereology and CIO KölnBonn, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Miller', 'Affiliation': 'Departments of Oncology and Medicine, Lady Davis Institute and Segal Cancer Centre, Jewish General Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'Department of Medical Oncology, Sir Charles Gairdner Hospital and School of Medicine and Physiology, University of Western Australia, Perth, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mirakhur', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Cancer Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Swann', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu154']
3365,32020733,Acute intense exercise improves sleep and decreases next morning consumption of energy-dense food in adolescent girls with obesity and evening chronotype.,"BACKGROUND


Although adolescence and obesity are related to impaired sleep duration and quality, exercise was admitted as a nonpharmacological treatment for sleep and better control of energy balance.
OBJECTIVES


To investigate the acute effects of intense exercise on sleep and subsequent dietary intake.
METHODS


Sixteen adolescent girls with obesity (age 13.7 ± 1.1 years, weight 82.7 ± 10.2 kg, body mass index (BMI) 30.5 ± 3.4 kg/m 2  , fat mass (FM) 39.2 ± 3.1%, Pittsburgh Sleep Quality Index (PSQI) 8.6 ± 2.8, paediatric daytime sleepiness scale (PDSS) 19.6 ± 5.9) took part in two experimental sessions in a random order: Control (CTL) and Exercise (EX). The two sessions were identical except for a continuous ergocycle exercise bout lasting 40 minutes and performed at 70% VO 2max  at the end of the morning of EX. Energy expenditure and sleep were measured by accelerometry and next-morning dietary intake in an ad libitum meal.
RESULTS


Higher sleep duration (P < 0.03) and quality (decreased WASO: P < 0.02; increased SE%: P < 0.02) were observed in EX compared with CTL. This was associated with a nonsignificant decrease in caloric intake (-78 kcal) and a significant decrease in food energy density (P < 0.04), fat, and sugar consumption (respectively, P < 0.02 and P < 0.05) the following morning.
CONCLUSIONS


Acute exercise efficaciously increased sleep duration and quality, resulting in a decrease in subsequent energy-dense food consumption in adolescent girls with obesity.",2020,"RESULTS


Higher sleep duration (P < 0.03) and quality (decreased WASO: P < 0.02; increased SE%: P < 0.02) were observed in EX compared with CTL.","['adolescent girls with obesity and evening chronotype', 'adolescent girls with obesity', 'Sixteen adolescent girls with obesity (age 13.7\u2009±\u20091.1\u2009years, weight 82.7\u2009±\u200910.2 kg, body mass index (BMI) 30.5\u2009±\u20093.4 kg/m 2  , fat mass (FM) 39.2\u2009±\u20093.1%, Pittsburgh Sleep Quality Index (PSQI) 8.6\u2009±\u20092.8, paediatric daytime sleepiness scale (PDSS) 19.6\u2009±\u20095.9) took part in two experimental sessions in a random order']","['Control (CTL) and Exercise (EX', 'intense exercise', 'Acute intense exercise']","['Energy expenditure and sleep', 'quality', 'fat, and sugar consumption', 'food energy density', 'caloric intake', 'sleep duration and quality', 'sleep duration']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0222045'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",16.0,0.0378991,"RESULTS


Higher sleep duration (P < 0.03) and quality (decreased WASO: P < 0.02; increased SE%: P < 0.02) were observed in EX compared with CTL.","[{'ForeName': 'Oussama', 'Initials': 'O', 'LastName': 'Saidi', 'Affiliation': 'Laboratoire des Adaptations Métaboliques en conditions Physiologiques et Physiopathologiques (AME2P), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Rochette', 'Affiliation': 'CHU Clermont-Ferrand, Pédiatrie, Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bovet', 'Affiliation': 'Laboratoire des Adaptations Métaboliques en conditions Physiologiques et Physiopathologiques (AME2P), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Merlin', 'Affiliation': 'CHU Clermont-Ferrand, Pédiatrie, Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duché', 'Affiliation': ""Laboratoire Impact de l'Activité Physique sur la Santé (IAPS), Université de Toulon, Toulon, France.""}]",Pediatric obesity,['10.1111/ijpo.12613']
3366,24608196,"Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study.","BACKGROUND


NEPA is a novel oral fixed-dose combination of netupitant (NETU), a new highly selective neurokinin-1 (NK1) receptor antagonist (RA) and palonosetron (PALO), a pharmacologically and clinically distinct 5-hydroxytryptamine type 3 (5-HT3) RA. This study was designed to determine the appropriate clinical dose of NETU to combine with PALO for evaluation in the phase 3 NEPA program.
PATIENTS AND METHODS


This randomized, double-blind, parallel group study in 694 chemotherapy naïve patients undergoing cisplatin-based chemotherapy for solid tumors compared three different oral doses of NETU (100, 200, and 300 mg) + PALO 0.50 mg with oral PALO 0.50 mg, all given on day 1. A standard 3-day aprepitant (APR) + IV ondansetron (OND) 32 mg regimen was included as an exploratory arm. All patients received oral dexamethasone on days 1-4. The primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) during the overall (0-120 h) phase.
RESULTS


All NEPA doses showed superior overall CR rates compared with PALO (87.4%, 87.6%, and 89.6% for NEPA100, NEPA200, and NEPA300, respectively versus 76.5% PALO; P < 0.050) with the highest NEPA300 dose studied showing an incremental benefit over lower NEPA doses for all efficacy endpoints. NEPA300 was significantly more effective than PALO and numerically better than APR + OND for all secondary efficacy endpoints of no emesis, no significant nausea, and complete protection (CR plus no significant nausea) rates during the acute (0-24 h), delayed (25-120 h), and overall phases. Adverse events were comparable across groups with no dose response. The percent of patients developing electrocardiogram changes was also comparable.
CONCLUSIONS


Each NEPA dose provided superior prevention of chemotherapy-induced nausea and vomiting (CINV) compared with PALO following highly emetogenic chemotherapy; however, NEPA300 was the best dose studied, with an advantage over lower doses for all efficacy endpoints. The combination of NETU and PALO was well tolerated with a similar safety profile to PALO and APR + OND.",2014,"NEPA300 was significantly more effective than PALO and numerically better than APR + OND for all secondary efficacy endpoints of no emesis, no significant nausea, and complete protection (CR plus no significant nausea) rates during the acute (0-24 h), delayed (25-120 h), and overall phases.",['694 chemotherapy naïve patients undergoing'],"['emetogenic chemotherapy', ' PALO 0.50 mg with oral PALO', 'NEPA', 'standard 3-day aprepitant (APR) + IV ondansetron (OND', 'oral dexamethasone', 'cisplatin-based chemotherapy', 'APR + OND', 'netupitant and palonosetron', 'NEPA300']","['nausea and vomiting', 'Adverse events', 'complete response (CR: no emesis, no rescue medication', 'Efficacy and safety', 'nausea and vomiting (CINV', 'superior overall CR rates', 'electrocardiogram changes', 'nausea, and complete protection (CR plus no significant nausea) rates']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",694.0,0.20776,"NEPA300 was significantly more effective than PALO and numerically better than APR + OND for all secondary efficacy endpoints of no emesis, no significant nausea, and complete protection (CR plus no significant nausea) rates during the acute (0-24 h), delayed (25-120 h), and overall phases.","[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Hesketh', 'Affiliation': 'Lahey Hospital & Medical Center, Burlington, USA. Electronic address: paul.hesketh@lahey.org.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Corporate Clinical Development and Statistics & Data Management, Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Corporate Clinical Development and Statistics & Data Management, Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Palmas', 'Affiliation': 'Corporate Clinical Development and Statistics & Data Management, Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alyasova', 'Affiliation': 'Federal State Institution, Privolzhsky District Medical Center under the Federal Medical-Biological Agency of Russia, Nizhny Novgorod, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnepropetrovsk Medical Academy, Dnepropetrovsk, Ukraine.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lisyanskaya', 'Affiliation': 'City Clinical Oncology Dispensary, Saint Petersburg, Russia.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu110']
3367,30817982,"Lifestyle multidomain intervention, omega-3 supplementation, or both for reducing the risk of developing clinically relevant depressive symptoms in older adults with memory complaints? Secondary analysis from the MAPT trial.","BACKGROUND


We tested the associations of a lifestyle multidomain intervention (MI), omega-3 supplementation (O3) or their combination with the change of clinically meaningful depressive symptoms in older adults.
METHODS


Secondary analysis of the 3-year Multidomain Alzheimer Preventive Trial (MAPT), in which 1679 people, ≥70 years with memory complaints were randomized into: MI, O3, MI + O3, or placebo. MI was composed of nutritional and physical activity counselling and cognitive training. O3 supplementation corresponded to a daily dose of 1000 mg of omega-3. Discrete-time cox regressions were performed for each outcome. Three binary variables of incidence of depressive symptoms were created from the 15-item geriatric depression scale (GDS-15): minimum clinically meaningful depressive symptoms (≥2-point increase in GDS-15), moderate depressive symptoms (GDS-15 ≥ 5), and severe depressive symptoms (GDS-15 ≥ 10) DS.
RESULTS


Discrete-time cox proportional hazards have found no associations for all of the analysis. The incidence of severe depressive symptoms across groups were, respectively: 1.1, 2.4, 2.3 and 2.5 per 100 person year for MI + O3, for O3, for MI, for placebo. There was a trend for a decreased risk of developing severe DS compared to placebo in the MI + O3 group (p = 0.085 after adjustment).
CONCLUSIONS


To conclude, we did not find any association of a lifestyle multidomain intervention with the onset of clinically depressive symptoms in older adults with memory complaints. A study with a more intensive multidomain intervention might bring further insights on this topic.",2019,"The incidence of severe depressive symptoms across groups were, respectively: 1.1, 2.4, 2.3 and 2.5 per 100 person year for MI + O3, for O3, for MI, for placebo.","['older adults with memory complaints', 'Secondary analysis of the 3-year Multidomain Alzheimer Preventive Trial (MAPT), in which 1679 people, ≥70\u202fyears with memory complaints', 'older adults']","['lifestyle multidomain intervention', 'intensive multidomain intervention', 'placebo', 'nutritional and physical activity counselling and cognitive training', 'O3 supplementation', 'MI, O3, MI\u202f+\u202fO3, or placebo', 'Lifestyle multidomain intervention, omega-3 supplementation', 'omega-3', 'lifestyle multidomain intervention (MI), omega-3 supplementation (O3) or their combination']","['risk of developing severe DS', 'depressive symptoms', 'severe depressive symptoms', '15-item geriatric depression scale (GDS-15): minimum clinically meaningful depressive symptoms (≥2-point increase in GDS-15), moderate depressive symptoms (GDS-15\u202f≥\u202f5), and severe depressive symptoms (GDS-15\u202f≥\u202f10) DS']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",1679.0,0.0990394,"The incidence of severe depressive symptoms across groups were, respectively: 1.1, 2.4, 2.3 and 2.5 per 100 person year for MI + O3, for O3, for MI, for placebo.","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Maltais', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France. Electronic address: mathieu.maltais@usherbrooke.ca.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France; UMR INSERM, 1027 University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Kristell', 'Initials': 'K', 'LastName': 'Pothier', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Cantet', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France; UMR INSERM, 1027 University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'UMR INSERM, 1027 University of Toulouse III, Toulouse, France; Department of Public Health, CHU Toulouse, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France; UMR INSERM, 1027 University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France; UMR INSERM, 1027 University of Toulouse III, Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Experimental gerontology,['10.1016/j.exger.2019.02.010']
3368,31881614,"A Preliminary Report of the Biochemical and Clinical Effects of 1,4-Diaminobutane on Prevention of Human Hypertrophic Scars.","Objective evidence for the role of inhibition of collagen cross-linking in human scar using a nontoxic topical inhibitor, 1,4-diaminobutane (1,4 DAB), in patients with scars at risk for hypertrophic scar formation is presented. The authors used a concentration of 1,4 DAB of 0.8% (weight/volume) in a cream base similar to Glaxal Base. Application was once per day at night. The control was treated with cream base alone. In treatment phase studies at 2 months, tissue biopsies were performed and used to determine a therapeutic effect biochemically in paired scars harvested chosen with typical hypertrophic scars at two major treatment centers. Tissue transglutaminase activity revealed a significant reduction of the ε-(γ-glutamyl)lysine cross-links in the treated scars: 7.96 ± 1.51 pmol/µmol amino acid versus 14.78 ± 3.52 pmol/µmol amino acid. A subset of paired scars (n = 15) was also analyzed for soluble procollagen type III amino propeptide. The effect was a significant increase in procollagen type III amino propeptide in the scars treated with 1,4 DAB compared with sham-treated scars: 47.75 ± 4.6 µg/mg wet weight versus 39.08 ± 6.02 µg/mg wet weight, respectively. Levels of tissue 1,4 DAB was found to be twice as high in the presence of the active cream versus in the tissue of the control group. In subsequent prophylaxis studies, the authors treated 44 breast reduction patients prospectively with active cream to one or the other side in a double-blind randomized fashion. Hardness (in grams) measured using a Rex Durometer at 6 and 12 weeks postoperatively along with photographs were analyzed. The mean value ± SD of 24.98 ± 1.2 g on the active side versus 31.76 ± 1.1 g on the sham side was significantly different (p < 0.05). The patient scale scores of the Patient and Observer Scar Assessment Scale were also requested by survey in a responding 27-patient subgroup at a minimum 1 year postoperatively, and the differences between the two sides were found to be statistically significant, where the mean on the active side was 14.07 ± 1.34 and the mean on the sham side was 21.41 ± 1 (p < 0.05). The results are evidence to support the use of this agent in prevention of hypertrophic scars. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, II.",2020,Tissue transglutaminase activity revealed a significant reduction of the ε-(γ-glutamyl)lysine cross-links in the treated scars: 7.96 ± 1.51 pmol/µmol amino acid versus 14.78 ± 3.52 pmol/µmol amino acid.,"['patients with scars at risk for hypertrophic scar formation', 'Human Hypertrophic Scars']","['nontoxic topical inhibitor, 1,4-diaminobutane (1,4 DAB', '1,4-Diaminobutane']","['Levels of tissue', 'procollagen type III amino propeptide', 'patient scale scores of the Patient and Observer Scar Assessment Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162810', 'cui_str': 'Scars, Hypertrophic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0034170', 'cui_str': 'Tetramethylenediamine'}, {'cui': 'C0086162', 'cui_str': 'Dab (substance)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0033240', 'cui_str': 'Type III Procollagen'}, {'cui': 'C0336604', 'cui_str': 'Patient scale, device (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",,0.0475427,Tissue transglutaminase activity revealed a significant reduction of the ε-(γ-glutamyl)lysine cross-links in the treated scars: 7.96 ± 1.51 pmol/µmol amino acid versus 14.78 ± 3.52 pmol/µmol amino acid.,"[{'ForeName': 'Kenneth N', 'Initials': 'KN', 'LastName': 'Dolynchuk', 'Affiliation': 'Winnipeg, Manitoba; and Edmonton, Alberta, Canada From the Section of Plastic Surgery, Department of Surgery, University of Manitoba; and the Division of Plastic Surgery, Department of Surgery and Critical Care Medicine, University of Alberta.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Tredget', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006413']
3369,29949232,"The effects of melatonin supplementation on mental health, metabolic and genetic profiles in patients under methadone maintenance treatment.","This investigation was designed to determine the effect of melatonin supplementation on mental health parameters, metabolic and genetic profiles in patients under methadone maintenance treatment (MMT). This randomized, double-blind, placebo-controlled, clinical trial was conducted among 54 patients under MMT. Participants were randomly allocated to receive either 10 mg melatonin (2 melatonin capsules, 5 mg each) (n = 26) or placebo (n = 28) once a day, 1 hour before bedtime for 12 weeks. Melatonin supplementation significantly decreased Pittsburgh Sleep Quality Index (β -4.08; 95 percent CI, -5.51, -2.65; P < 0.001), Beck Depression Inventory index (β -5.46; 95% CI, -8.92, -2.00; P = 0.003) and Beck Anxiety Inventory index (β -3.87; 95% CI, -5.96, -1.77; P = 0.001) and significantly increased International Index of Erectile Functions (β 5.59; 95% CI, 1.76, 9.42; P = 0.005) compared with the placebo. Subjects who received melatonin supplements had significantly lower serum insulin levels (β -2.53; 95% CI, -4.48, -0.59; P = 0.01), homeostasis model of assessment-insulin resistance (β -0.56; 95% CI, -1.03, -0.09; P = 0.01) and higher quantitative insulin sensitivity check index (β 0.01; 95% CI, 0.004, 0.02; P = 0.009) and HDL-cholesterol levels (β 3.71; 95% CI, 1.77, 5.64; P = 0.002) compared to placebo. Additionally, melatonin intake resulted in a significant reduction in serum high sensitivity C-reactive protein (β -0.15; 95% CI, -0.27, -0.02; P = 0.02), malondialdehyde (β -0.31; 95% CI, -0.57, -0.05; P = 0.02) and protein carbonyl (β -0.06; 95% CI, -0.09, -0.04; P < 0.001). This trial indicated that taking melatonin supplements for 12 weeks by patients under MMT had beneficial effects on their mental health metabolic profiles.",2019,"Melatonin supplementation significantly decreased Pittsburgh Sleep Quality Index (β -4.08; 95 percent CI, -5.51, -2.65; P < 0.001), Beck Depression Inventory index (β -5.46; 95% CI, -8.92, -2.00; P = 0.003) and Beck Anxiety Inventory index (β -3.87; 95% CI, -5.96, -1.77; P = 0.001) and significantly increased International Index of Erectile Functions (β 5.59; 95% CI, 1.76, 9.42; P = 0.005) compared with the placebo.","['patients under methadone maintenance treatment (MMT', 'patients under methadone maintenance treatment', '54 patients under MMT']","['melatonin', 'placebo', 'melatonin supplementation', 'melatonin supplements', 'melatonin (2 melatonin capsules, 5\xa0mg each) (n\xa0=\xa026) or placebo', 'Melatonin supplementation']","['serum insulin levels', 'serum high sensitivity C-reactive protein', 'Beck Depression Inventory index', 'mental health, metabolic and genetic profiles', 'Pittsburgh Sleep Quality Index', 'Beck Anxiety Inventory index', 'homeostasis model of assessment-insulin resistance ', 'protein carbonyl', 'International Index of Erectile Functions', 'mental health metabolic profiles', 'higher quantitative insulin sensitivity check index', 'mental health parameters, metabolic and genetic profiles', 'HDL-cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2986505', 'cui_str': 'Genotype Profile'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",54.0,0.802982,"Melatonin supplementation significantly decreased Pittsburgh Sleep Quality Index (β -4.08; 95 percent CI, -5.51, -2.65; P < 0.001), Beck Depression Inventory index (β -5.46; 95% CI, -8.92, -2.00; P = 0.003) and Beck Anxiety Inventory index (β -3.87; 95% CI, -5.96, -1.77; P = 0.001) and significantly increased International Index of Erectile Functions (β 5.59; 95% CI, 1.76, 9.42; P = 0.005) compared with the placebo.","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction Studies, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Department of Addiction Studies, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': ""Pure North S'Energy Foundation, Calgary, AB, Canada.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Motmaen', 'Affiliation': 'Department of Psychiatry, School of Medicine, Kashan University of Medical Science, Kashan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mehrzad', 'Affiliation': 'Department of Psychiatry, School of Medicine, Kashan University of Medical Science, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Russel J', 'Initials': 'RJ', 'LastName': 'Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad-Amin', 'Initials': 'MA', 'LastName': 'Karimi', 'Affiliation': 'Department of Educational Sciences, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}]",Addiction biology,['10.1111/adb.12650']
3370,31710095,"Nicotinamide riboside does not alter mitochondrial respiration, content or morphology in skeletal muscle from obese and insulin-resistant men.","KEY POINTS


This is the first long-term human clinical trial to report on effects of nicotinamide riboside (NR) on skeletal muscle mitochondrial function, content and morphology. NR supplementation decreases nicotinamide phosphoribosyltransferase (NAMPT) protein abundance in skeletal muscle. NR supplementation does not affect NAD metabolite concentrations in skeletal muscle. Respiration, distribution and quantity of muscle mitochondria are unaffected by NR. NAMPT in skeletal muscle correlates positively with oxidative phosphorylation Complex I, sirtuin 3 and succinate dehydrogenase.
ABSTRACT


Preclinical evidence suggests that the nicotinamide adenine dinucleotide (NAD +  ) precursor nicotinamide riboside (NR) boosts NAD +  levels and improves diseases associated with mitochondrial dysfunction. We aimed to determine if dietary NR supplementation in middle-aged, obese, insulin-resistant men affects mitochondrial respiration, content and morphology in skeletal muscle. In a randomized, placebo-controlled clinical trial, 40 participants received 1000 mg NR or placebo twice daily for 12 weeks. Skeletal muscle biopsies were collected before and after the intervention. Mitochondrial respiratory capacity was determined by high-resolution respirometry on single muscle fibres. Protein abundance and mRNA expression were measured by Western blot and quantitative PCR analyses, respectively, and in a subset of the participants (placebo n = 8; NR n = 8) we quantified mitochondrial fractional area and mitochondrial morphology by laser scanning confocal microscopy. Protein levels of nicotinamide phosphoribosyltransferase (NAMPT), an essential NAD +  biosynthetic enzyme in skeletal muscle, decreased by 14% with NR. However, steady-state NAD +  levels as well as gene expression and protein abundance of other NAD +  biosynthetic enzymes remained unchanged. Neither respiratory capacity of skeletal muscle mitochondria nor abundance of mitochondrial associated proteins were affected by NR. Moreover, no changes in mitochondrial fractional area or network morphology were observed. Our data do not support the hypothesis that dietary NR supplementation has significant impact on skeletal muscle mitochondria in obese and insulin-resistant men. Future studies on the effects of NR on human skeletal muscle may include both sexes and potentially provide comparisons between young and older people.",2020,Neither respiratory capacity of skeletal muscle mitochondria nor abundance of mitochondrial associated proteins were affected by NR.,"['young and older people', 'obese and insulin-resistant men', '40 participants received 1,000\xa0mg', 'middle-aged, obese, insulin-resistant men']","['nicotinamide phosphoribosyltransferase (NAMPT', 'dietary NR supplementation', 'placebo', 'NR or placebo', 'Nicotinamide riboside', 'nicotinamide adenine dinucleotide (NAD +  ) precursor nicotinamide riboside (NR) boosts NAD']","['skeletal muscle mitochondria', 'mitochondrial fractional area or network morphology', 'Skeletal muscle biopsies', 'Mitochondrial respiratory capacity', 'Protein abundance and mRNA expression']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}]","[{'cui': 'C0068707', 'cui_str': 'Visfatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068711', 'cui_str': 'pyridinium, 3-(aminocarbonyl)-1-beta-D-ribofuranosyl-'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0026237', 'cui_str': 'Mitochondria'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",40.0,0.218645,Neither respiratory capacity of skeletal muscle mitochondria nor abundance of mitochondrial associated proteins were affected by NR.,"[{'ForeName': 'Ole L', 'Initials': 'OL', 'LastName': 'Dollerup', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Chubanava', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Agerholm', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Stine D', 'Initials': 'SD', 'LastName': 'Søndergård', 'Affiliation': 'Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Altıntaş', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Andreas B', 'Initials': 'AB', 'LastName': 'Møller', 'Affiliation': 'Research Laboratory for Biochemical Pathology, Department of Clinical Medicine, Aarhus University, Denmark.'}, {'ForeName': 'Kasper F', 'Initials': 'KF', 'LastName': 'Høyer', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Ringgaard', 'Affiliation': 'The MR Research Centre, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Stødkilde-Jørgensen', 'Affiliation': 'The MR Research Centre, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Gareth G', 'Initials': 'GG', 'LastName': 'Lavery', 'Affiliation': 'Clinical and Experimental Medicine, University of Birmingham, UK.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Barrès', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Larsen', 'Affiliation': 'Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Prats', 'Affiliation': 'Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Research Laboratory for Biochemical Pathology, Department of Clinical Medicine, Aarhus University, Denmark.'}, {'ForeName': 'Jonas T', 'Initials': 'JT', 'LastName': 'Treebak', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",The Journal of physiology,['10.1113/JP278752']
3371,31721153,Cost analysis comparison between peripherally inserted central catheters and implanted chest ports in patients with cancer-A health economic evaluation of the PICCPORT trial.,"BACKGROUND


A reliable central venous access device is a cornerstone in the treatment of cancer. Both peripherally inserted central catheters (PICC) and totally implanted chest ports (PORT) are commonly used for the delivery of chemotherapy. Both types of catheter can cause adverse events such as catheter-related deep venous thrombosis (CR-DVT), infection and mechanical complications.
METHOD


We conducted a randomized controlled trial including 399 patients with cancer and performed a health economic evaluation investigating the cost related to PICCs and PORTs using several clinically relevant dimensions from a healthcare perspective. The cost was determined using process and cost estimate models.
RESULT


PICCs are associated with a higher total cost when compared with PORTs. Combining the costs of all categories, the prize per inserted device was 824.58 EUR for PICC and 662.34 EUR for PORT. When adjusting for total catheter dwell time the price was 6.58 EUR/day for PICC and 3.01 EUR/day for PORT. The difference in CR-DVT was the main contributor to the difference in cost. The daily cost of PICC is approximately twice to that of PORT.
CONCLUSION


We have demonstrated that the cost from a healthcare perspective is higher in cancer patients receiving a PICC than to those with a PORT. The difference is driven mainly by the cost related to the management of adverse events. Our findings are relevant to anaesthetists, oncologists and vascular access clinicians and should be considered when choosing vascular access device prior to chemotherapy.",2020,When adjusting for total catheter dwell time the price was 6.58 EUR/day for PICC and 3.01 EUR/day for PORT.The difference in CR-DVT was the main contributor to the difference in cost.,"['patients with cancer - a health economicevaluation of the PICCPORT trial', 'cancer patients receiving a PICC than to those with a PORT', '399 patients with cancer and performed a health economic evaluation investigating the cost related to PICCs and PORTs using several clinically relevant dimensions from a health care perspective']","['peripherally inserted central catheters and implanted chest ports', 'peripherally inserted central catheters (PICC) and totally implanted chest ports (PORT']","['total cost', 'daily cost of PICC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0179740', 'cui_str': 'Long line'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",399.0,0.0347152,When adjusting for total catheter dwell time the price was 6.58 EUR/day for PICC and 3.01 EUR/day for PORT.The difference in CR-DVT was the main contributor to the difference in cost.,"[{'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Taxbro', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Hammarskjöld', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Juhlin', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Hagman', 'Affiliation': 'Department of Oncology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bernfort', 'Affiliation': 'Division of Health Care Analysis, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiothoracic Surgery, Anaesthesia and Intensive Care, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13505']
3372,31350066,Re: Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-resistant Prostate Cancer.,,2020,,['Asymptomatic or Minimally Symptomatic Metastatic Castration-resistant Prostate Cancer'],[],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]",[],[],,0.029115,,"[{'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, Tübingen University, Tübingen, Germany. Electronic address: arnulf.stenzl@med.uni-tuebingen.de.'}]",European urology,['10.1016/j.eururo.2019.07.025']
3373,31609882,"DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2).","BACKGROUND


DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks.
METHODS


In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks).
RESULTS


Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively).
CONCLUSIONS


Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, I.",2020,DaxibotulinumtoxinA for injection may offer a prolonged duration of response (median ≥ 24 weeks) and is generally well tolerated.,"['subjects with moderate or severe glabellar lines at maximum frown', 'glabellar lines', '609 subjects enrolled (405 daxibotulinumtoxinA, 204 placebo']","['placebo', 'placebo or 40U daxibotulinumtoxinA for injection', 'DaxibotulinumtoxinA']","['mild glabellar line severity', 'glabellar line severity', 'injection site pain']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}]",609.0,0.64603,DaxibotulinumtoxinA for injection may offer a prolonged duration of response (median ≥ 24 weeks) and is generally well tolerated.,"[{'ForeName': 'Jean D', 'Initials': 'JD', 'LastName': 'Carruthers', 'Affiliation': 'Vancouver, British Columbia, Canada; Boca Raton, Fla.; Beverly Hills and Newark, Calif.; and Nashville, Tenn. From the Departments of Ophthalmology and Visual Sciences and Dermatology and Skin Science, University of British Columbia; private practice; Clinical Testing of Beverly Hills; and Revance Therapeutics, Inc. AboutSkin Dermatology and Dermsurgery, PC Aesthetic Solutions, PA Aesthetic Solutions, PA Aesthetic Solutions, PA Arthur Swift Research, Inc. Arthur Swift Research, Inc. Arthur Swift Research, Inc. ATS Clinical Research ATS Clinical Research Bertucci MedSpa, Inc. Bertucci MedSpa, Inc. BOYD Brian S. Biesman, M.D. Brian S. Biesman, M.D. California Dermatology & Clinical Research Institute Center for Dermatology and Dermatologic Surgery Clinical Testing of Beverly Hills Dermatology Consulting Services, PLLC Dermatology Consulting Services, PLLC Dermetics Dermetics DuPage Medical Group Dermatology Institute DuPage Medical Group Dermatology Institute DuPage Medical Group Dermatology Institute DuPage Medical Group Dermatology Institute DuPage Medical Group Dermatology Institute Image Dermatology PC Juva Skin and Laser Center Juva Skin and Laser Center Lupo Center for Aesthetic and General Dermatology Lupo Center for Aesthetic and General Dermatology Mariwalla Dermatology Omni Aesthetic MD Premier Clinical Research Premier Clinical Research Richard G. Glogau, MD, Inc. Skin Care and Laser Physicians of Beverly Hills Skin Care and Laser Physicians of Beverly Hills Skin Care and Laser Physicians of Beverly Hills Skin Research Institute Skin Specialists, PC Skin Specialists, PC Skin Specialists, PC SkinCare Physicians SkinCare Physicians Sweat Clinics of Canada Total Skin and Beauty Dermatology Center, PC Total Skin and Beauty Dermatology Center, PC Total Skin and Beauty Dermatology Center, PC Medical Associates, Inc.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Fagien', 'Affiliation': ''}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'Humphrey', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Biesman', 'Affiliation': ''}, {'ForeName': 'Conor J', 'Initials': 'CJ', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Roman G', 'Initials': 'RG', 'LastName': 'Rubio', 'Affiliation': ''}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Sue Ellen', 'Initials': 'SE', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Soderberg', 'Affiliation': ''}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Swift', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Borsuk', 'Affiliation': ''}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papanastasiou', 'Affiliation': ''}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Shamban', 'Affiliation': ''}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Simzar', 'Affiliation': ''}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Bertucci', 'Affiliation': ''}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Waller', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Boyd', 'Affiliation': ''}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Churchill', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Burgess', 'Affiliation': ''}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Dhir', 'Affiliation': ''}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Draelos', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Draelos', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'Channy', 'Initials': 'C', 'LastName': 'Muhn', 'Affiliation': ''}, {'ForeName': 'Ashish C', 'Initials': 'AC', 'LastName': 'Bhatia', 'Affiliation': ''}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'Te-Shao', 'Initials': 'TS', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Brandice M', 'Initials': 'BM', 'LastName': 'Brazell', 'Affiliation': ''}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Downie', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Woody', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Lupo', 'Affiliation': ''}, {'ForeName': 'Skylar', 'Initials': 'S', 'LastName': 'Souyoul', 'Affiliation': ''}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Mariwalla', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eviatar', 'Affiliation': ''}, {'ForeName': 'Wm Philip', 'Initials': 'WP', 'LastName': 'Werschler', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Schade', 'Affiliation': ''}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Glogau', 'Affiliation': ''}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Naissan', 'Initials': 'N', 'LastName': 'Wesley', 'Affiliation': ''}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Schlessinger', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Perillo', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Dover', 'Affiliation': ''}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Morton', 'Affiliation': ''}, {'ForeName': 'Nowell', 'Initials': 'N', 'LastName': 'Solish', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Monheit', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Essig', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Yoelin', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Yoelin', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006327']
3374,31812330,Verbal suggestions of nicotine content modulate ventral tegmental neural activity during the presentation of a nicotine-free odor in cigarette smokers.,"Expectancies of nicotine content have been shown to impact smokers' subjective responses and smoking behaviors. However, little is known about the neural substrates modulated by verbally induced expectancies in smokers. In this study we used functional magnetic resonance imaging (fMRI) to investigate how verbally induced expectations, regarding the presence or absence of nicotine, modulated smokers' neural response to a nicotine-free odor. While laying in the scanner, all participants (N = 24) were given a nicotine-free odor, but whereas one group was correctly informed about the absence of nicotine (control group n = 12), the other group was led to believe that the presented odor contained nicotine (expectancy group n = 12). Smokers in the expectancy group had significantly increased blood-oxygen-level-dependent (BOLD) responses during the presentation of the nicotine-free odor in the left ventral tegmental area (VTA), and in the right insula, as compared to smokers in the control group (Regions of interest analysis with pFWE-corrected p ≤ 0.05). At a more liberal uncorrected statistical level (p-unc ≤ 0.001), increased bilateral reactivity in the dorsolateral prefrontal cortex (dlPFC) was also observed in the expectancy group as compared with the control group. Our findings suggest that nicotine-expectancies induced through verbal instructions can modulate nicotine relevant brain regions, without nicotine administration, and provide further neural support for the key role that cognitive expectancies play in the cause and treatment of nicotine dependence.",2020,"At a more liberal uncorrected statistical level (p-unc ≤ 0.001), increased bilateral reactivity in the dorsolateral prefrontal cortex (dlPFC) was also observed in the expectancy group as compared with the control group.",['cigarette smokers'],"['nicotine', 'functional magnetic resonance imaging (fMRI']","['dorsolateral prefrontal cortex (dlPFC', 'blood-oxygen-level-dependent (BOLD) responses', 'bilateral reactivity']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",24.0,0.014928,"At a more liberal uncorrected statistical level (p-unc ≤ 0.001), increased bilateral reactivity in the dorsolateral prefrontal cortex (dlPFC) was also observed in the expectancy group as compared with the control group.","[{'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Faria', 'Affiliation': ""Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany; Department of Psychology, Uppsala University, Uppsala, Sweden; Center for Pain and the Brain, Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: vanda.faria@psyk.uu.se.""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Han', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany; Key Laboratory of Cognition and Personality (Ministry of Education), Southwest University, Chongqing, China; Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Akshita', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enck', 'Affiliation': 'Department of Internal Medicine VI: Psychosomatic Medicine and Psychotherapy, Tuebingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.11.007']
3375,31239321,Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use.,"PURPOSE


Cetuximab, which modulates immune responses, may affect the efficacy of subsequent immunotherapy. Here, we assessed outcomes with nivolumab, by prior cetuximab exposure, in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinum-containing chemotherapy.
PATIENTS AND METHODS


In the randomized, open-label, phase III CheckMate 141 trial, patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure. The primary endpoint was overall survival (OS); additional endpoints were progression-free survival, objective response rate, and safety.
RESULTS


In patients with prior cetuximab exposure, the median OS was 7.1 months with nivolumab versus 5.1 months with IC (HR, 0.84; 95% CI, 0.62-1.15); OS benefit with nivolumab was maintained across most demographic subgroups. In patients without prior cetuximab exposure, the median OS was 8.2 months with nivolumab versus 4.9 months with IC (HR, 0.52; 95% CI, 0.35-0.77); OS benefit with nivolumab was maintained across patient baseline subgroups including tumor programmed death ligand 1 (PD-L1) expression (<1% or ≥1%). Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups.
CONCLUSIONS


Nivolumab appeared to improve efficacy versus IC regardless of prior cetuximab use, supporting its use in patients with R/M SCCHN with or without prior cetuximab exposure. The reduction in risk of death with nivolumab compared with IC was greater in patients without prior cetuximab exposure versus with prior cetuximab exposure.",2019,"Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups.
","['patients with R/M SCCHN with or without prior cetuximab exposure', 'patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinum-containing chemotherapy', 'Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck']","['Nivolumab', ""nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure""]","['risk of death', 'overall survival (OS); additional endpoints were progression-free survival, objective response rate, and safety', 'median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0280574,"Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups.
","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'Departments of Otolaryngology and Immunology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania. ferrisrl@upmc.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Medical Oncology, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Medical Oncology, Gustave Roussy, Villejuif Cedex, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'Radiotherapy and Imaging, Royal Marsden/The Institute of Cancer Research, National Institute of Health Research Biomedical Research Center, London, United Kingdom.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Medical Oncology, Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'Medical Oncology, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Shanmugasundaram', 'Initials': 'S', 'LastName': 'Ramkumar', 'Affiliation': 'Clinical Oncology, University Hospital Southampton/NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'Head and Neck/Cutaneous/Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'Department of Oncology, Hematology, Immuno-oncology and Rheumatology, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Division of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'A Dimitrios', 'Initials': 'AD', 'LastName': 'Colevas', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Concha-Benavente', 'Affiliation': 'Departments of Otolaryngology and Immunology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lynch', 'Affiliation': 'Global Clinical Development, Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Global Biometrics Sciences, Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3944']
3376,31828753,Long-term patient-important outcomes after septic shock: A protocol for 1-year follow-up of the CLASSIC trial.,"BACKGROUND


In patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes.
AIM


To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.
METHODS


In this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.
DISCUSSION


With this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock.",2020,The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy.,"['patients with septic shock', 'patients randomised into the CLASSIC trial']",['restrictive vs standard-care intravenous (IV) fluid therapy'],"['EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score', 'cause mortality, health-related quality of life (HRQoL) and cognitive function 1\xa0year', '1-year mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3496286'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.298029,The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy.,"[{'ForeName': 'Maj-Brit N', 'Initials': 'MN', 'LastName': 'Kjaer', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tine S', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Madsen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Hjortrup', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Egerod', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Section of Anaesthesia and Intensive Care, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jon H', 'Initials': 'JH', 'LastName': 'Laake', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anaesthesiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Bern (Inselspital), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Nalos', 'Affiliation': 'Medical Intensive Care Unit, 1. Interni klinika, Fakultni Nemocnice, Plzen, Czech Republic.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Iwan C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'Department of Intensive Care, Maastricht University Medical Center+, University Maastricht, Maastrict, The Netherlands.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Intensive Care, Guy's and St Thomas' Hospital, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trial Unit, Intensive Care National Audit & Research Centre (ICNARC), London, UK.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cecconi', 'Affiliation': 'Department of Intensive Care Medicine, Humanitas Research Hospital, Milan, Italy.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Ferrer', 'Affiliation': ""Department of Intensive Care, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Manu L N G', 'Initials': 'MLNG', 'LastName': 'Malbrain', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Brussels (UZB), Jette, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ahlstedt', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjaellands Hospital, University Hospital of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Gyldensted', 'Affiliation': 'Department of Intensive Care, Gentofte Hospital, Gentofte, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nebrich', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vang', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Randers Hospital, Randers, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Sølling', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Lillebaelt Hospital, Kolding, Denmark.'}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13519']
3377,31849040,Hyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events: Protocol for a 2 × 2 factorial randomised clinical trial.,"BACKGROUND


Myocardial injury after non-cardiac surgery occurs in a high number of patients, resulting in increased mortality in the post-operative period. The use of high inspiratory oxygen concentrations may cause hyperoxia, which is associated with impairment of coronary blood flow. Furthermore, the surgical stress response increases reactive oxygen species, which is involved in several perioperative complications including myocardial injury and death. Avoidance of hyperoxia and substitution of reactive oxygen species scavengers may be beneficial. Our primary objective is to examine the effect of oxygen and added antioxidants for prevention of myocardial injury assessed by area under the curve for troponin measurements during the first three post-operative days.
METHODS


The VIXIE trial (VitamIn and oXygen Interventions and cardiovascular Events) is an investigator-initiated, blinded, 2 × 2 factorial multicentre clinical trial. We include 600 patients with cardiovascular risk factors undergoing major non-cardiac surgery. Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both. The primary outcome is the area under the curve for high-sensitive cardiac troponin release during the first three post-operative days as a marker of the extent of myocardial injury. Secondary outcomes are mortality, non-fatal myocardial infarction and non-fatal serious adverse events within 30 days.
PERSPECTIVE


The current trial will provide further evidence for clinicians on optimal administration of perioperative oxygen in surgical patients with cardiovascular risks and the clinical effects of two common antioxidants.",2020,Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both.,"['surgical patients with cardiovascular risks', '600 patients with cardiovascular risk factors undergoing major non-cardiac surgery']","['vitamin C and an infusion of N-acetylcysteine or matching placebo of both', 'Hyperoxia and antioxidants', 'oxygen and added antioxidants', 'VIXIE trial (VitamIn and oXygen Interventions and Cardiovascular Events']","['area under the curve for high-sensitive cardiac troponin release', 'mortality, non-fatal myocardial infarction, and non-fatal serious adverse events']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",600.0,0.552589,Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both.,"[{'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Petersen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik C', 'Initials': 'FC', 'LastName': 'Loft', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Eske K', 'Initials': 'EK', 'LastName': 'Aasvang', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Vester-Andersen', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anaesthesiology, Copenhagen University Hospital Herlev-Gentofte, Herlev, Denmark.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13518']
3378,31831203,Effect of add-on ramelteon therapy on sleep and circadian rhythm disruption in patients with schizophrenia: A randomized controlled trial.,"The sleep and circadian rhythm disruptions in schizophrenia are attributed to a decrease in nocturnal melatonin level which may worsen if treated with conventional sedative drugs. This study was planned to evaluate the effects of add-on ramelteon on sleep and circadian rhythm disturbances in schizophrenia. A randomized, rater-blinded clinical trial was conducted on 120 patients with schizophrenia. Patients were categorized into predominantly positive (PG) or negative (NG) symptoms depending on Positive and Negative Syndrome Scale (PANSS) scoring, and then they were randomized into control (haloperidol/risperidone) or test (add-on ramelteon) groups. After recruitment, baseline serum melatonin, serum AANAT, urinary melatonin and Pittsburgh Sleep Quality Index (PSQI) were evaluated. Patients were reassessed after 4 weeks of therapy with antipsychotics with or without ramelteon. A significantly greater increase in night-time melatonin level (PG: 10·19; 95%CI: 1·42 to 18·97; p = 0·024; NG: 18·74; 95%CI: 8·48 to 29·0; p = 0·001), decrease in PSQI scores (PG: -1·57; 95%CI: -2·59 to -0·55; p = 0·003; NG: -2·49; 95%CI: -4·59 to -0·39; p = 0·021), increase in urinary melatonin (PG: 0·20; 95% CI: 0·056 to 0·35; p = 0·008; NG :0·15; 95% CI: 0·01 to 0·29; p = 0·034), increase in serum AANAT (PG: 4·61; 95%CI: 1·34 to 7·87; p = 0·007; NG:3·46; 95%CI: 1·30 to 5·63; p = 0·002) and improvement in PANSS score were found in patients receiving add-on ramelteon. The increase in serum melatonin and decrease in PSQI score were greater with predominantly negative symptom group in comparison to positive symptom group. Ramelteon may be considered as an add-on therapy with antipsychotic drugs for sleep and circadian rhythm disturbances in schizophrenia.",2020,The increase in serum melatonin and decrease in PSQI score were greater with predominantly negative symptom group in comparison to positive symptom group.,"['Patients were categorized into predominantly positive (PG) or negative (NG) symptoms depending on Positive and Negative Syndrome Scale (PANSS) scoring, and then they were randomized into', 'patients with schizophrenia', '120 patients with schizophrenia', 'schizophrenia']","['NG', 'ramelteon therapy', 'antipsychotics with or without ramelteon', 'control (haloperidol/risperidone']","['sleep and circadian rhythm disruption', 'PSQI scores (PG', 'serum melatonin', 'PSQI score', 'baseline serum melatonin, serum AANAT, urinary melatonin and Pittsburgh Sleep Quality Index (PSQI', 'urinary melatonin', 'nocturnal melatonin level', 'night-time melatonin level', 'PANSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C1565316', 'cui_str': 'ramelteon'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",120.0,0.152149,The increase in serum melatonin and decrease in PSQI score were greater with predominantly negative symptom group in comparison to positive symptom group.,"[{'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Maiti', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India. Electronic address: pharm_rituparna@aiimsbhubaneswar.edu.in.'}, {'ForeName': 'Biswa Ranjan', 'Initials': 'BR', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Monalisa', 'Initials': 'M', 'LastName': 'Jena', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Santanu', 'Initials': 'S', 'LastName': 'Nath', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.'}, {'ForeName': 'Pallabi', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Psychiatry, Hi-tech Medical College and Hospital, Bhubaneswar, Odisha, India.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.11.008']
3379,19628570,"A randomized placebo-controlled study of tamoxifen after adjuvant chemotherapy in premenopausal women with early breast cancer (National Cancer Institute of Canada--Clinical Trials Group Trial, MA.12).","BACKGROUND


In the early 1990s, the role of adjuvant tamoxifen in premenopausal women with early breast cancer (EBC) was not established. Similarly, optimum timing relative to adjuvant chemotherapy and efficacy of tamoxifen in hormone receptor-negative tumors were unclear.
PATIENTS AND METHODS


Premenopausal women with EBC, any hormone receptor status, after surgery received standard adjuvant chemotherapy [doxorubicin (adriamycin)/cyclophosphamide, cyclophosphamide/methotrexate/5-fluorouracil, or cyclophosphamide/epirubicin/5-fluorouracil] followed by randomization to tamoxifen or placebo for 5 years. Outcomes were overall survival (OS), disease-free survival (DFS), toxicity, and compliance with therapy.
RESULTS


Median follow-up for 672 women was 9.7 years. Multivariate analysis showed improved DFS [78.2% versus 71.3% at 5 years; hazard ratio (HR) 0.77; P = 0.056] and a trend for improved OS (86.6% versus 82.1% at 5 years; HR 0.78; P = 0.12). There was no evidence of greater benefit for the receptor-positive subgroup. Compliance with treatment was suboptimal in both arms, with 103 (31%) women on tamoxifen and 70 (21%) on placebo-stopping therapy early because of toxicity, refusal, or other choices.
CONCLUSIONS


Adjuvant tamoxifen, given after chemotherapy to premenopausal women with EBC, improved 5-year DFS. Poor compliance may have reduced treatment efficacy.",2010,Multivariate analysis showed improved DFS [78.2% versus 71.3% at 5 years; hazard ratio (HR) 0.77; P = 0.056] and a trend for improved OS (86.6% versus 82.1% at 5 years; HR 0.78; P = 0.12).,"['premenopausal women with early breast cancer (EBC', '672 women was 9.7 years', 'premenopausal women with EBC', 'Premenopausal women with EBC, any hormone receptor status, after surgery received', 'premenopausal women with early breast cancer (National Cancer Institute of Canada--Clinical Trials Group Trial, MA.12']","['Adjuvant tamoxifen', 'adjuvant chemotherapy', 'placebo', 'tamoxifen or placebo', 'tamoxifen', 'standard adjuvant chemotherapy [doxorubicin (adriamycin)/cyclophosphamide, cyclophosphamide/methotrexate/5-fluorouracil, or cyclophosphamide/epirubicin/5-fluorouracil', 'adjuvant tamoxifen']","['improved OS', 'DFS', 'toxicity, refusal, or other choices', '5-year DFS', 'overall survival (OS), disease-free survival (DFS), toxicity, and compliance with therapy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0449443', 'cui_str': 'Receptor status (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1320290', 'cui_str': 'Clinical trial group'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",672.0,0.35862,Multivariate analysis showed improved DFS [78.2% versus 71.3% at 5 years; hazard ratio (HR) 0.77; P = 0.056] and a trend for improved OS (86.6% versus 82.1% at 5 years; HR 0.78; P = 0.12).,"[{'ForeName': 'V H C', 'Initials': 'VHC', 'LastName': 'Bramwell', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Centre, Calgary, Alberta. Electronic address: vivienbr@cancerboard.ab.ca.'}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Department of Medical Oncology, Sunnybrook Odette Cancer Centre, Toronto, Ontario.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': 'Central Office, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tonkin', 'Affiliation': 'Department of Medical Oncology, Cross Cancer Institute, Edmonton, Alberta.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Vachhrajani', 'Affiliation': 'Department of Radiation Oncology, Saskatoon Cancer Centre, Saskatoon, Saskatchewan.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Vandenberg', 'Affiliation': 'Department of Medical Oncology, London Regional Cancer Program, London, Ontario.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Robert', 'Affiliation': 'Department of Surgical Oncology, Hôpital Du Saint-Sacrement, Quebec City, Quebec.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arnold', 'Affiliation': 'Department of Medical Oncology, Juravinski Cancer Centre, Hamilton, Ontario.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Graham', 'Affiliation': 'Central Office, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': 'Central Office, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp326']
3380,19633042,"An open-label, randomized phase II study of adecatumumab, a fully human anti-EpCAM antibody, as monotherapy in patients with metastatic breast cancer.","BACKGROUND


High-level expression of epithelial cell adhesion molecule (EpCAM) is associated with unfavorable prognosis in breast cancer. This study was designed to investigate two doses of the fully human IgG1 anti-EpCAM antibody adecatumumab (MT201) in patients with metastatic breast cancer (MBC).
METHODS


A total of 109 patients were stratified into high- and low-level EpCAM expression by immunohistochemical staining of primary tumors and subsequently randomly assigned to receive monotherapy with either high- (6 mg/kg every two weeks (q2w)) or low-dose adecatumumab (2 mg/kg/ q2w) until disease progression.
RESULTS


No complete or partial tumor responses could be confirmed by central RECIST assessment. The probability for tumor progression was significantly lower in patients receiving high-dose adecatumumab and expressing high levels of EpCAM (hazard ratio 0.43; P = 0.0057 versus low dose and low EpCAM). Three of 18 patients with highest EpCAM expression treated with adecatumumab developed new metastases up to week 6, compared with 14 of 29 patients with low EpCAM. Most frequent treatment-related adverse events (high dose/low dose) were chills (59%/20%), nausea (55%/18%), fatigue (39%/23%) and diarrhea (43%/7%).
CONCLUSIONS


Single-agent adecatumumab shows dose- and target-dependent clinical activity in EpCAM-positive MBC, albeit no objective tumor regression. Further investigation of adecatumumab in patients with EpCAM-overexpressing tumors and lower tumor burden is warranted.",2010,"Three of 18 patients with highest EpCAM expression treated with adecatumumab developed new metastases up to week 6, compared with 14 of 29 patients with low EpCAM.","['109 patients were stratified into high- and low-level EpCAM expression by immunohistochemical staining of primary tumors', 'patients with EpCAM-overexpressing tumors', 'patients with metastatic breast cancer (MBC', 'patients with metastatic breast cancer', '18 patients with highest EpCAM expression treated with']","['adecatumumab', 'fully human IgG1 anti-EpCAM antibody adecatumumab (MT201', 'monotherapy with either high- (6 mg/kg every two weeks (q2w)) or low-dose adecatumumab']","['diarrhea', 'nausea', 'adverse events', 'probability for tumor progression', 'chills', 'complete or partial tumor responses', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704265', 'cui_str': 'GA733 Tumor-Associated Antigen'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1741817'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0020855', 'cui_str': 'IgG1'}, {'cui': 'C1704265', 'cui_str': 'GA733 Tumor-Associated Antigen'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",109.0,0.0336541,"Three of 18 patients with highest EpCAM expression treated with adecatumumab developed new metastases up to week 6, compared with 14 of 29 patients with low EpCAM.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Department of Obstetrics and Gynecology, Johannes Gutenberg University, Mainz.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Scheulen', 'Affiliation': 'Department of Medicine (Cancer Research), West German Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dittrich', 'Affiliation': 'Third Medical Department, Centre for Oncology and Hematology, CEADDP, Applied Cancer Research, Institution for Translational Research Vienna, Vienna; Ludwig Boltzmann-Institute for Applied Cancer Research, Vienna.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Obrist', 'Affiliation': 'Department of Pathology, St Vinzenz Hospital, Zams, Austria.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Marschner', 'Affiliation': 'Practice for Oncology and Hematology, Freiburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Medical Oncology Unit, Oncologisch Centrum Sint-Augustinus, Antwerp, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Clinical Development, Micromet AG, Munich, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rüttinger', 'Affiliation': 'Clinical Development, Micromet AG, Munich, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'Department of Medicine (Cancer Research), West German Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Reinhardt', 'Affiliation': 'Clinical Development, Micromet AG, Munich, Germany. Electronic address: carsten.reinhardt@micromet.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Unité Chemiothérapie, Université Libre de Bruxelles, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp314']
3381,32012217,Percutaneous Cordotomy for Pain Palliation in Advanced Cancer: A Randomized Clinical Trial Study Protocol.,"BACKGROUND


Cancer pain, one of the most common symptoms for patients with advanced cancer, is often refractory to maximal medical therapy. A controlled clinical trial is needed to provide definitive evidence to support the use of ablative procedures such as cordotomy for patients with medically refractory cancer pain.
OBJECTIVE


To assess the efficacy of cordotomy for patients with unilateral advanced cancer pain using a controlled clinical trial study design. The secondary objectives are to define the patient experience of cordotomy for medically refractory cancer pain as well as to determine the utility of magnetic resonance imaging as a non-invasive biomarker for successful cordotomy.
METHODS


We will undertake a single-institution, double-blind, sham-controlled clinical trial of cordotomy in patients with refractory cancer pain. Patients in the cordotomy arm will undergo a percutaneous computed tomography-guided cordotomy at C1-C2, while patients in the control arm will undergo a similar procedure where the needle will not penetrate the thecal sac. The primary endpoint will be the reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale.
EXPECTED OUTCOMES


We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.
DISCUSSION


This randomized clinical trial comparing cordotomy with a control intervention will provide the level of evidence necessary to determine whether cordotomy should be the standard of care intervention for patients with advanced cancer pain.",2020,"EXPECTED OUTCOMES


We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.
","['patients with advanced cancer', 'patients with medically refractory cancer pain', 'Advanced Cancer', 'patients with advanced cancer pain', 'patients with unilateral advanced cancer pain', 'patients with refractory cancer pain']","['Percutaneous Cordotomy', 'cordotomy', 'control intervention', 'percutaneous computed tomography-guided cordotomy at C1-C2']","['reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale', 'pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0196243', 'cui_str': 'Spinal percutaneous cordotomy (procedure)'}, {'cui': 'C0010009', 'cui_str': 'Cordotomy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}]",,0.191581,"EXPECTED OUTCOMES


We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.
","[{'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Vedantam', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Loretta A', 'Initials': 'LA', 'LastName': 'Williams', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Dhanalakshmi', 'Initials': 'D', 'LastName': 'Koyyalagunta', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Salahadin', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Dougherty', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Mendoza', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Roland L', 'Initials': 'RL', 'LastName': 'Bassett', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Hou', 'Affiliation': 'Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Neurosurgery,['10.1093/neuros/nyz527']
3382,19633051,Adverse prognostic value of peritumoral vascular invasion: is it abrogated by adequate endocrine adjuvant therapy? Results from two International Breast Cancer Study Group randomized trials of chemoendocrine adjuvant therapy for early breast cancer.,"BACKGROUND


Peritumoral vascular invasion (PVI) may assist in assigning optimal adjuvant systemic therapy for women with early breast cancer.
PATIENTS AND METHODS


Patients participated in two International Breast Cancer Study Group randomized trials testing chemoendocrine adjuvant therapies in premenopausal (trial VIII) or postmenopausal (trial IX) node-negative breast cancer. PVI was assessed by institutional pathologists and/or central review on hematoxylin-eosin-stained slides in 99% of patients (analysis cohort 2754 patients, median follow-up >9 years).
RESULTS


PVI, present in 23% of the tumors, was associated with higher grade tumors and larger tumor size (trial IX only). Presence of PVI increased locoregional and distant recurrence and was significantly associated with poorer disease-free survival. The adverse prognostic impact of PVI in trial VIII was limited to premenopausal patients with endocrine-responsive tumors randomized to therapies not containing goserelin, and conversely the beneficial effect of goserelin was limited to patients whose tumors showed PVI. In trial IX, all patients received tamoxifen: the adverse prognostic impact of PVI was limited to patients with receptor-negative tumors regardless of chemotherapy.
CONCLUSION


Adequate endocrine adjuvant therapy appears to abrogate the adverse impact of PVI in node-negative disease, while PVI may identify patients who will benefit particularly from adjuvant therapy.",2010,Presence of PVI increased locoregional and distant recurrence and was significantly associated with poorer disease-free survival.,"['premenopausal patients with endocrine-responsive tumors', 'in premenopausal (trial VIII) or postmenopausal (trial IX) node-negative breast cancer', 'early breast cancer', 'women with early breast cancer', 'Patients participated in two International Breast Cancer Study Group randomized trials testing']","['chemoendocrine adjuvant therapies', 'goserelin', 'tamoxifen', 'chemoendocrine adjuvant therapy']","['poorer disease-free survival', 'locoregional and distant recurrence', 'adverse prognostic impact of PVI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0445599', 'cui_str': 'VIII'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.148697,Presence of PVI increased locoregional and distant recurrence and was significantly associated with poorer disease-free survival.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan, Italy. Electronic address: giuseppe.viale@ieo.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': 'International Breast Cancer Study Group, Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusterson', 'Affiliation': 'Division of Cancer Sciences and Molecular Pathology, Faculty of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maiorano', 'Affiliation': 'Department of Pathological Anatomy, University of Bari, Bari, Italy.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Mastropasqua', 'Affiliation': 'Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sonzogni', 'Affiliation': 'Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mallon', 'Affiliation': 'Division of Cancer Sciences and Molecular Pathology, Faculty of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Department of Medicine, Research Unit in Medical Senology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'International Breast Cancer Study Group, Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'International Breast Cancer Study Group, Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Brown', 'Affiliation': 'Melbourne Pathology, Collingwood, Victoria, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Golouh', 'Affiliation': 'Department of Pathology, Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': 'Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Öhlschlegel', 'Affiliation': 'Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'International Breast Cancer Study Group, Statistical Center, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'European Institute of Oncology, Milan, Italy; Department of Medicine, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'Scientific Committee, International Breast Cancer Study Group, Bern, Switzerland; School of Public Health, University of Sydney, Sydney, Australia.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp317']
3383,31997114,"ERG shrinks by 10% when reducing dark adaptation time to 10 min, but only for weak flashes.","PURPOSE


To compare dark-adapted (DA) ERG between 10, 15 and 20 min of dark adaptation (DA).
METHODS


In a counterbalanced random block design, 40 healthy adult subjects were dark-adapted for 10, 15 or 20 min before we recorded ERGs to nine flash strengths from 0.001 to 10.0 cd s/m 2  (dilated pupils) with a DTL-like electrode. Before and between sessions, the room was lit. Apart from choosing a wider range of stimulus strengths, and adding shorter DA times, the recordings fully complied with the ISCEV ERG Standard, namely using corneal electrodes, mydriasis and a standard DA sequence.
RESULTS


The a-wave amplitude was not affected by any adaptation condition. For the b-wave amplitude, effects of reduced DA time are stronger for weaker flashes: Reducing DA from 20 to 10 min had no measurable effect on the DA 3 ERG, but reduced the DA 0.01 b-wave significantly (p < 0.0001) to 87 ± 2% (mean ± SEM). The DA 0.001 b-wave (not part of the ISCEV ERG Standard) was more affected (down to 72 ± 4%). There was a small, but significant, increase, only for weak flashes, in a- and b-wave peak times for 20 compared to 10-min dark adaptation time.
CONCLUSION


Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG. The reduction in DA 0.01 ERGs to 87 ± 2% agrees with Hamilton and Graham (Doc Ophthalmol 133:11-19, 2016. https://doi.org/10.1007/s10633-016-9554-x ) who found 90 ± 2% and with Asakawa et al. (Doc Ophthalmol 139:33-44, 2019. https://doi.org/10.1007/s10633-019-09693-8 ) who found 83%. Pending verification in pathophysiological states, the current results suggest that one might be able to correct for the 10% amplitude loss when gaining 10 min through shortened DA.",2020,Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG.,['40 healthy adult subjects'],"['dark-adapted (DA) ERG between 10, 15 and 20\xa0min of dark adaptation (DA']","['Reducing dark adaptation time', 'weak flashes, in a- and b-wave peak times']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0010985', 'cui_str': 'Scotopic Adaptation'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0010985', 'cui_str': 'Scotopic Adaptation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",40.0,0.0213724,Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bach', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. michael.bach@uni-freiburg.de.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Meroni', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.'}, {'ForeName': 'Sven P', 'Initials': 'SP', 'LastName': 'Heinrich', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.'}]",Documenta ophthalmologica. Advances in ophthalmology,['10.1007/s10633-020-09751-6']
3384,32014273,Impact of inpatient diabetes transitions of care consult on glycemic control.,"OBJECTIVE(S)


An evaluation of a diabetes consult service for hospitalized patients was completed to determine effect on glycemic control.
METHODS


This medical record review was conducted to determine impact of a short-term program on patients with diabetes. The electronic medical record was used to identify patients diagnosed with diabetes mellitus and hospitalized from September 2016 to September 2017. A case-control design was utilized to compare patients with an inpatient order for the diabetes transitions of care service to those receiving usual care. The consultation service consisted of inpatient diabetes education and follow-up post discharge. The HbA1c reduction of adult inpatients those who completed a consult (n = 67) and those who received usual care (n = 67) were compared. Statistical analyses were conducted.
RESULTS


For the primary outcome of HbA1c reduction at 3 months, absolute difference from baseline to 3 months in the intervention was -2.9 % compared to 0.9 % in the control group (p < 0.001).
CONCLUSIONS


Participation in the service reduced HbA1c at 3 months and 6 months post-discharge, reduced 30-day all-cause readmissions, and increased percentage of patients with HbA1c <9.0 % at 6 months post-discharge.
PRACTICAL IMPLICATIONS


A consult-based diabetes transitions of care service decreased HbA1c versus usual care.",2020,"CONCLUSIONS


Participation in the service reduced HbA1c at 3 months and 6 months post-discharge, reduced 30-day all-cause readmissions, and increased percentage of patients with HbA1c <9.0 % at 6 months post-discharge.
","['hospitalized patients', 'patients with diabetes', 'patients diagnosed with diabetes mellitus and hospitalized from September 2016 to September 2017', 'adult inpatients those who completed a consult (n\u202f=\u202f67) and those who received usual care (n\u202f=\u202f67', 'patients with an inpatient order for the diabetes transitions of care service to those receiving usual care']",[],['HbA1c reduction'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]",[],"[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",67.0,0.0365179,"CONCLUSIONS


Participation in the service reduced HbA1c at 3 months and 6 months post-discharge, reduced 30-day all-cause readmissions, and increased percentage of patients with HbA1c <9.0 % at 6 months post-discharge.
","[{'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Powers', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States.'}, {'ForeName': 'Marquita', 'Initials': 'M', 'LastName': 'Winder', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States. Electronic address: marquita.winder@va.gov.'}, {'ForeName': 'MaryAnne', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Brittain', 'Affiliation': 'Columbia VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209, United States.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.010']
3385,19628566,AIB1 is a predictive factor for tamoxifen response in premenopausal women.,"BACKGROUND


Clinical trials implicate the estrogen receptor (ER) coactivator amplified in breast cancer 1 (AIB1) to be a prognostic and a treatment-predictive factor, although results are not unanimous. We have further investigated this using a controlled randomised trial of tamoxifen versus control.
MATERIALS AND METHODS


A total of 564 premenopausal women were entered into a randomised study independent of ER status. Using a tissue microarray, AIB1 and ER were analysed by immunohistochemistry.
RESULTS


AIB1 scores were obtained from 349 women. High AIB1 correlated to factors of worse prognosis (human epidermal growth factor receptor 2, Nottingham histological grade 3, and lymph node metastases) and to ER negativity. In the control arm, high AIB1 was a negative prognostic factor for recurrence-free survival (RFS) (P = 0.02). However, ER-positive patients with high AIB1 responded significantly to tamoxifen treatment (P = 0.002), increasing RFS to the same level as for systemically untreated patients with low AIB1. Although ER-positive patients with low AIB1 had a better RFS from the beginning, this was not further improved by tamoxifen (P = 0.8).
CONCLUSIONS


In the control group, high AIB1 was a negative prognostic factor. However, ER-positive patients with high AIB1 responded significantly to tamoxifen. This implicates high AIB1 to be an independent predictive factor of improved response to tamoxifen and not, as has previously been discussed, a factor predicting tamoxifen resistance.",2010,"In the control arm, high AIB1 was a negative prognostic factor for recurrence-free survival (RFS) (P = 0.02).","['premenopausal women', '564 premenopausal women']",['tamoxifen'],"['negative prognostic factor for recurrence-free survival (RFS', 'AIB1 scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",564.0,0.0917863,"In the control arm, high AIB1 was a negative prognostic factor for recurrence-free survival (RFS) (P = 0.02).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Alkner', 'Affiliation': 'Departments of Oncology.'}, {'ForeName': 'P-O', 'Initials': 'PO', 'LastName': 'Bendahl', 'Affiliation': 'Departments of Oncology.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Grabau', 'Affiliation': 'Departments of Pathology, Clinical Sciences, Lund University.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lövgren', 'Affiliation': 'Departments of Oncology.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Stål', 'Affiliation': 'Department of Oncology, Clinical and Experimental Medicine, Linköping University.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Surgery, Clinical Sciences, Lund University, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Departments of Oncology. Electronic address: Marten.Ferno@med.lu.se.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp293']
3386,19759186,Surrogate end points for overall survival and local control in neoadjuvant rectal cancer trials: statistical evaluation based on the FFCD 9203 trial.,"BACKGROUND


In resectable rectal cancer trials, pathological parameters are early preoperative treatment efficacy measures. Their validation as surrogate end points for long-term clinical outcomes would allow to reduce trial duration. The aim was to evaluate potential surrogates for overall survival (OS) and local control (LC) in preoperative T3/T4 rectal cancer trials. Candidate variables included ypT and ypN stages, T downstaging, tumor regression grade (TRG), and circumferential resection margin (CRM) status.
PATIENTS AND METHODS


In the Fédération Francophone de Cancérologie Digestive (FFCD) 9203 trial, 742 eligible patients were randomly assigned to receive preoperative radiotherapy with or without concurrent chemotherapy. Surrogacy was evaluated using Prentice criteria and the proportion of treatment effect (PTE) explained by each potential surrogate.
RESULTS


None of the candidate surrogates fulfilled all Prentice criteria. Data analyses did not provide interpretable PTE measures for OS. Regarding LC, the highest PTE was reached by TRG, which explained 12% of the effect on local recurrence. This proportion may not exceed 41% [95% confidence interval (CI) -1% to 41%]. PTE explained by the CRM status was associated with a wide uncertainty (95% CI -81% to 105%), which does not exclude a potentially high degree of surrogacy.
CONCLUSION


In the FFCD 9203 trial, pathological parameters were not surrogate for OS or LC.",2010,"PTE explained by the CRM status was associated with a wide uncertainty (95% CI -81% to 105%), which does not exclude a potentially high degree of surrogacy.
","['preoperative T3/T4 rectal cancer trials', '742 eligible patients']",['preoperative radiotherapy with or without concurrent chemotherapy'],"['local recurrence', 'ypT and ypN stages, T downstaging, tumor regression grade (TRG), and circumferential resection margin (CRM) status', 'overall survival (OS) and local control (LC']","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",742.0,0.26079,"PTE explained by the CRM status was associated with a wide uncertainty (95% CI -81% to 105%), which does not exclude a potentially high degree of surrogacy.
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Methy', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive, Inserm U866 Faculté de Médecine, Dijon; University of Burgundy, Dijon. Electronic address: nicolas.methy@u-bourgogne.fr.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bedenne', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive, Inserm U866 Faculté de Médecine, Dijon; University of Burgundy, Dijon; Department of Gastroenterology, University Hospital Le Bocage, Dijon.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Conroy', 'Affiliation': 'Department of Medical Oncology, Centre Alexis Vautrin, Vandoeuvre-lès-Nancy.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': 'Department of Gastroenterology, University Hospital Robert Debre, Reims.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Chapet', 'Affiliation': 'Department of Radiotherapy, University Hospital Pierre Benite, Lyon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': 'Department of Digestive Oncology, Gustave Roussy Institute, Villejuif.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Gérard', 'Affiliation': 'Department of Radiotherapy, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive, Inserm U866 Faculté de Médecine, Dijon.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp340']
3387,19717534,Long-term endometrial effects in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES)--a randomised controlled trial of exemestane versus continued tamoxifen after 2-3 years tamoxifen.,"BACKGROUND


The antiestrogen tamoxifen may have partial estrogen-like effects on the postmenopausal uterus. Aromatase inhibitors (AIs) are increasingly used after initial tamoxifen in the adjuvant treatment of postmenopausal early breast cancer due to their mechanism of action: a potential benefit being a reduction of uterine abnormalities caused by tamoxifen.
PATIENTS AND METHODS


Sonographic uterine effects of the steroidal AI exemestane were studied in 219 women participating in the Intergroup Exemestane Study: a large trial in postmenopausal women with estrogen receptor-positive (or unknown) early breast cancer, disease free after 2-3 years of tamoxifen, randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years adjuvant treatment. The primary end point was the proportion of patients with abnormal (> or =5 mm) endometrial thickness (ET) on transvaginal ultrasound 24 months after randomisation.
RESULTS


The analysis included 183 patients. Two years after randomisation, the proportion of patients with abnormal ET was significantly lower in the exemestane compared with tamoxifen arm (36% versus 62%, respectively; P = 0.004). This difference emerged within 6 months of switching treatment (43.5% versus 65.2%, respectively; P = 0.01) and disappeared within 12 months of treatment completion (30.8% versus 34.7%, respectively; P = 0.67).
CONCLUSION


Switching from tamoxifen to exemestane significantly reverses endometrial thickening associated with continued tamoxifen.",2010,"This difference emerged within 6 months of switching treatment (43.5% versus 65.2%, respectively; P = 0.01) and disappeared within 12 months of treatment completion (30.8% versus 34.7%, respectively; P = 0.67).
","['219 women participating in the Intergroup Exemestane Study: a large trial in postmenopausal women with estrogen receptor-positive (or unknown) early breast cancer, disease free after 2-3 years of', '183 patients', 'postmenopausal early breast cancer', 'postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES)--a randomised controlled trial of']","['tamoxifen or switch to exemestane to complete 5 years adjuvant treatment', 'tamoxifen', 'steroidal AI exemestane', 'Aromatase inhibitors (AIs', 'tamoxifen to exemestane', 'exemestane', 'antiestrogen tamoxifen']","['endometrial thickening', 'proportion of patients with abnormal (> or =5 mm) endometrial thickness (ET', 'proportion of patients with abnormal ET']","[{'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0752229', 'cui_str': 'Antiestrogens'}]","[{'cui': 'C0743516', 'cui_str': 'Endometrial thickening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}]",219.0,0.0945598,"This difference emerged within 6 months of switching treatment (43.5% versus 65.2%, respectively; P = 0.01) and disappeared within 12 months of treatment completion (30.8% versus 34.7%, respectively; P = 0.67).
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bertelli', 'Affiliation': 'Department of Oncology, Singleton Hospital, South West Wales Cancer Institute, Swansea. Electronic address: gianfilippo.bertelli@swansea-tr.wales.nhs.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'ICR-CTSU, Section of Clinical Trials, Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ireland', 'Affiliation': 'ICR-CTSU, Section of Clinical Trials, Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Snowdon', 'Affiliation': 'ICR-CTSU, Section of Clinical Trials, Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Drosik', 'Affiliation': 'Department of Oncology, Regional Cancer Center, Opole, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Karnicka-Mlodkowska', 'Affiliation': 'Department of Chemotherapy, Maritime Hospital, Gdynia, Poland.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Coombes', 'Affiliation': 'Cancer Research UK Department of Cancer Medicine, Imperial College London, Hammersmith Hospitals Trust, London, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'ICR-CTSU, Section of Clinical Trials, Institute of Cancer Research, Sutton, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp358']
3388,19880433,"Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients: a randomized controlled trial.","BACKGROUND


Substantial numbers of cancer patients use complementary medicine therapies, even without a supportive evidence base. This study aimed to evaluate in a randomized controlled trial, the use of Medical Qigong (MQ) compared with usual care to improve the quality of life (QOL) of cancer patients.
PATIENTS AND METHODS


One hundred and sixty-two patients with a range of cancers were recruited. QOL and fatigue were measured by Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Fatigue, respectively, and mood status by Profile of Mood State. The inflammatory marker serum C-reactive protein (CRP) was monitored serially.
RESULTS


Regression analysis indicated that the MQ group significantly improved overall QOL (t(144) = -5.761, P < 0.001), fatigue (t(153) = -5.621, P < 0.001), mood disturbance (t(122) =2.346, P = 0.021) and inflammation (CRP) (t(99) = 2.042, P < 0.044) compared with usual care after controlling for baseline variables.
CONCLUSIONS


This study indicates that MQ can improve cancer patients' overall QOL and mood status and reduce specific side-effects of treatment. It may also produce physical benefits in the long term through reduced inflammation.",2010,This study indicates that MQ can improve cancer patients' overall QOL and mood status and reduce specific side-effects of treatment.,"['One hundred and sixty-two patients with a range of cancers were recruited', 'cancer patients']","['Medical Qigong (MQ', 'medical Qigong', 'MQ']","['mood disturbance (t(122) ', 'Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Fatigue', 'fatigue (t(153) ', 'inflammation (CRP', 'inflammatory marker serum C-reactive protein (CRP', 'quality of life (QOL', 'quality of life, fatigue, mood and inflammation', 'overall QOL', 'QOL and fatigue']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",162.0,0.195539,This study indicates that MQ can improve cancer patients' overall QOL and mood status and reduce specific side-effects of treatment.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Concord Repatriation General Hospital, University of Sydney, Concord; Center for Medical Psychology and Evidence-based Decision-making, School of Psychology, University of Sydney; Sydney Cancer Center, Concord Repatriation General Hospital. Electronic address: bsoh@med.usyd.edu.au.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Butow', 'Affiliation': 'Center for Medical Psychology and Evidence-based Decision-making, School of Psychology, University of Sydney.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mullan', 'Affiliation': 'Center for Medical Psychology and Evidence-based Decision-making, School of Psychology, University of Sydney.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Department of Medicine, Concord Repatriation General Hospital, University of Sydney, Concord; Sydney Cancer Center, Concord Repatriation General Hospital.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beale', 'Affiliation': 'Department of Medicine, Concord Repatriation General Hospital, University of Sydney, Concord; Sydney Cancer Center, Concord Repatriation General Hospital.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Department of Medicine, Concord Repatriation General Hospital, University of Sydney, Concord; Department of Medical Oncology, Royal North Shore Hospital.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kothe', 'Affiliation': 'School of Psychology, University of Sydney.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'School of Medical Sydney, Notre Dame University, NSW, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rosenthal', 'Affiliation': 'Dana-Faber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp479']
3389,19675093,The strength of female sex as a prognostic factor in small-cell lung cancer: a pooled analysis of chemotherapy trials from the Manchester Lung Group and Medical Research Council Clinical Trials Unit.,"BACKGROUND


Previous studies reported that women survive longer than men, but experience greater toxicity, when treated for small-cell lung cancer (SCLC).
METHODS


Individual patient data from six randomized phase II/III chemotherapy trials, from the Manchester Lung Group and UK Medical Research Council, were pooled for analysis. End points included overall survival, response rate, toxicity, dose intensity (DI) and transfusion rates.
RESULTS


Of 1707 patients analyzed, 44% were women. At baseline, women had poorer performance status (PS) (57% versus 67% Eastern Cooperative Oncology Group PS 0-1/Karnofsky PS 80-100, P = 0.0004) and more were of normal weight or underweight (57% versus 48%, P = 0.003), but fewer were anemic (25% versus 62%, P < 0.0001). Response rates between women and men were similar (77% versus 76%, P = 0.64). In univariate [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.76-0.96, P = 0.006] and multivariate (HR 0.88, 95% CI 0.79-0.99, P = 0.04) analyses, female sex predicted for longer survival. Women experienced more grade 3/4 emesis (18% versus 9%, P < 0.0001) and grade 3/4 mucositis (13% versus 8%, P = 0.005) than men. There were no differences in DI, infections, transfusions or treatment-related deaths.
CONCLUSION


Data from >1700 patients in randomized SCLC chemotherapy trials confirm that women survive modestly longer than men but may experience greater toxicity.",2010,"Women experienced more grade 3/4 emesis (18% versus 9%, P < 0.0001) and grade 3/4 mucositis (13% versus 8%, P = 0.005) than men.","['small-cell lung cancer', '1707 patients']",[],"['overall survival, response rate, toxicity, dose intensity (DI) and transfusion rates', 'toxicity', 'poorer performance status (PS', 'grade 3/4 mucositis', 'DI, infections, transfusions or treatment-related deaths', 'grade 3/4 emesis', 'normal weight or underweight', 'Response rates']","[{'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]",,0.449577,"Women experienced more grade 3/4 emesis (18% versus 9%, P < 0.0001) and grade 3/4 mucositis (13% versus 8%, P = 0.005) than men.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wheatley-Price', 'Affiliation': 'Department of Medical Oncology. Electronic address: paulwp@doctors.org.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Biostatistics, Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Ashcroft', 'Affiliation': 'Department of Biostatistics, Christie Hospital, Manchester.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nankivell', 'Affiliation': 'Medical Research Council Clinical Trials Unit, London.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Stephens', 'Affiliation': 'Medical Research Council Clinical Trials Unit, London.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'White', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Thatcher', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Blackhall', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Department of Medical Oncology.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp300']
3390,19684105,Initial dose intensity has limited impact on the outcome of ABVD chemotherapy for advanced Hodgkin lymphoma (HL): data from UKLG LY09 (ISRCTN97144519).,"BACKGROUND


This analysis was undertaken to assess the relationship between the dose intensity (DI) of initial chemotherapy and outcome in a large cohort of patients with advanced Hodgkin lymphoma treated in a randomised controlled trial, in which detailed dose data were collected prospectively.
PATIENTS AND METHODS


Three-hundred and eighty patients randomly assigned to receive standard doxorubicin, bleomycin, vinblastine and dacarbazine who underwent at least two cycles of treatment were studied. With a median follow-up of 6.9 years, progression-free survival (PFS) from the end of cycle 2 was analysed according to DI during those cycles.
RESULTS


During the first two cycles, 25% of patients received >97% of planned DI, 37% received between 86% and 97% and 38% received <86%. DI during the first two cycles was correlated with DI during the remainder of the course, but there was no evidence that early DI influenced PFS (hazard ratio 0.87, 95% confidence interval 0.67-1.11; P = 0.265). Multivariate analysis also failed to confirm the influence of early DI on PFS or overall survival.
CONCLUSIONS


At the range of DI delivered in a multicentre trial using conventional therapy, there is no clear evidence that early DI influences outcome. This should be tested in a prospective study.",2010,"Multivariate analysis also failed to confirm the influence of early DI on PFS or overall survival.
","['Three-hundred and eighty patients randomly assigned to receive', 'advanced Hodgkin lymphoma (HL', 'patients with advanced Hodgkin lymphoma']","['standard doxorubicin, bleomycin, vinblastine and dacarbazine']","['PFS', 'PFS or overall survival', 'progression-free survival (PFS']","[{'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",380.0,0.23808,"Multivariate analysis also failed to confirm the influence of early DI on PFS or overall survival.
","[{'ForeName': 'W S', 'Initials': 'WS', 'LastName': 'Owadally', 'Affiliation': 'Cancer Sciences Division, Cancer Research UK Clinical Centre, Southampton.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'Cancer Division, Medical Research Council Clinical Trials Unit, London.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Radford', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Hancock', 'Affiliation': 'Department of Medical Oncology, Weston Park Hospital, Sheffield.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Cullen', 'Affiliation': 'Cancer Centre, Birmingham University Hospitals, Birmingham, UK.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Stenning', 'Affiliation': 'Cancer Division, Medical Research Council Clinical Trials Unit, London.'}, {'ForeName': 'P W M', 'Initials': 'PWM', 'LastName': 'Johnson', 'Affiliation': 'Cancer Sciences Division, Cancer Research UK Clinical Centre, Southampton. Electronic address: johnsonp@soton.ac.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp331']
3391,19828561,Prognostic and predictive factors in a randomized phase III trial comparing cisplatin-pemetrexed versus cisplatin-gemcitabine in advanced non-small-cell lung cancer.,"BACKGROUND


Baseline patient and disease characteristics are investigated in non-small-cell lung cancer (NSCLC) in an effort to predict response to treatment and optimize patients' outcomes. Histology has recently been identified in multiple NSCLC phase III trials as a predictive factor for survival in patients receiving pemetrexed regimens.
METHODS


Cox-adjusted models were used to further analyze a randomized phase III study in 1725 chemonaive patients with stage IIIB or IV NSCLC and Eastern Cooperative Oncology Group performance status (PS) of zero or one who received cisplatin plus pemetrexed (CP; C, 75 mg/m(2) and P, 500 mg/m(2)) or cisplatin plus gemcitabine (CG; C, 75 mg/m(2) and G, 1250 mg/m(2)) every 21 days.
RESULTS


Histology was confirmed to be predictive of CP efficacy and may also be prognostic. Gender, ethnicity, disease stage, smoking status, and PS were not predictive in either treatment arm but were shown to be prognostic in the nonsquamous population, consistent with the results in the overall NSCLC population.
CONCLUSIONS


NSCLC histology significantly predicts efficacy outcomes for patients receiving pemetrexed. Several other factors are prognostic for the overall study population as well as a subset of patients with advanced nonsquamous NSCLC.",2010,"Gender, ethnicity, disease stage, smoking status, and PS were not predictive in either treatment arm but were shown to be prognostic in the nonsquamous population, consistent with the results in the overall NSCLC population.
","['patients with advanced nonsquamous NSCLC', 'patients receiving pemetrexed regimens', 'advanced non-small-cell lung cancer', '1725 chemonaive patients with stage IIIB or IV NSCLC and Eastern Cooperative Oncology Group performance status (PS) of zero or one who received', 'patients receiving pemetrexed']","['cisplatin plus gemcitabine', 'cisplatin-pemetrexed versus cisplatin-gemcitabine', 'cisplatin plus pemetrexed (CP']",['CP efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]",[],1725.0,0.0916242,"Gender, ethnicity, disease stage, smoking status, and PS were not predictive in either treatment arm but were shown to be prognostic in the nonsquamous population, consistent with the results in the overall NSCLC population.
","[{'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Syrigos', 'Affiliation': 'Oncology Unit, Department of Medicine, Athens School of Medicine, Athens, Greece. Electronic address: knsyrigos@usa.net.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Respiratory Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'Department of Medical Oncology, BSES G Municipal Hospital and Railway Hospital, Mumbai, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'von Pawel', 'Affiliation': 'Department of Oncology, Asklepios-Fachkliniken Munchen Gauting, Gauting.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Manegold', 'Affiliation': 'Department of Surgery-Interdisciplinary Thoracic Oncology, Heidelberg University Medical Center, Mannheim, Germany.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Martins', 'Affiliation': 'Division of Medical Oncology, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Simms', 'Affiliation': 'Department of Statistics and Information Sciences, Eli Lilly Canada, Toronto, Canada.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Sugarman', 'Affiliation': 'Medical Oncology, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Visseren-Grul', 'Affiliation': 'Medical Oncology, Eli Lilly Netherlands, Utrecht, The Netherlands.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Clinical and Biological Sciences, Thoracic Oncology Unit, San Luigi Hospital, University of Turin, Turin, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp392']
3392,19703922,Excess of cardiovascular mortality among node-negative breast cancer patients irradiated for inner-quadrant tumors.,"BACKGROUND


Radiotherapy of the left breast is associated with higher cardiovascular mortality linked to cardiotoxic effect of irradiation. Radiotherapy of inner quadrants can be associated with greater heart irradiation, but no study has evaluated the effect of inner-quadrant irradiation on cardiovascular mortality.
PATIENTS AND METHODS


We identified 1245 women, the majority with breast-conserving surgery, irradiated for primary node-negative breast cancer from 1980 to 2004 registered at the Geneva Cancer Registry. We compared breast cancer-specific and cardiovascular mortality between inner-quadrant (n = 393) versus outer-quadrant tumors (n = 852) by multivariate Cox regression analysis.
RESULTS


After a mean follow-up of 7.7 years, 28 women died of cardiovascular disease and 91 of breast cancer. Patients with inner-quadrant tumors had a more than doubled risk of cardiovascular mortality compared with patients with outer-quadrant tumors (adjusted hazard ratio 2.5; 95% confidence interval 1.1-5.4). Risk was particularly increased in the period with higher boost irradiation. Patients with left-sided breast cancer had no excess of cardiovascular mortality compared with patients with right-sided tumors.
CONCLUSIONS


Radiotherapy of inner-quadrant breast cancer is associated with an important increase of cardiovascular mortality, a possible result of higher irradiation of the heart. For patients with inner-quadrant tumors, the heart should be radioprotected.",2010,Patients with inner-quadrant tumors had a more than doubled risk of cardiovascular mortality compared with patients with outer-quadrant tumors (adjusted hazard ratio 2.5; 95% confidence interval 1.1-5.4).,"['28 women died of cardiovascular disease and 91 of breast cancer', 'Patients with left-sided breast cancer', '1245 women, the majority with breast-conserving surgery, irradiated for primary node-negative breast cancer from 1980 to 2004 registered at the Geneva Cancer Registry', 'node-negative breast cancer patients irradiated for inner-quadrant tumors']",['Radiotherapy'],"['doubled risk of cardiovascular mortality', 'cardiovascular mortality', 'Risk', 'breast cancer-specific and cardiovascular mortality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.0393099,Patients with inner-quadrant tumors had a more than doubled risk of cardiovascular mortality compared with patients with outer-quadrant tumors (adjusted hazard ratio 2.5; 95% confidence interval 1.1-5.4).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bouchardy', 'Affiliation': 'Geneva Cancer Registry, Institute for Social and Preventive Medicine, University of Geneva. Electronic address: christine.bouchardymagnin@unige.ch.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rapiti', 'Affiliation': 'Geneva Cancer Registry, Institute for Social and Preventive Medicine, University of Geneva.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Usel', 'Affiliation': 'Geneva Cancer Registry, Institute for Social and Preventive Medicine, University of Geneva.'}, {'ForeName': 'S Balmer', 'Initials': 'SB', 'LastName': 'Majno', 'Affiliation': 'Division of Radiation Oncology, Geneva University Hospitals.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vlastos', 'Affiliation': 'Senology Unit, Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Benhamou', 'Affiliation': ""Institut National de la Santé et de la Recherche Médicale, U946, Fondation Jean Dausset Centre d'Etude du Polymorphisme Humain, Paris; Centre National de la Recherche Scientifique FRE2939, Gustave Roussy Institute, Villejuif, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Miralbell', 'Affiliation': 'Division of Radiation Oncology, Geneva University Hospitals.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Neyroud-Caspar', 'Affiliation': 'Geneva Cancer Registry, Institute for Social and Preventive Medicine, University of Geneva.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Geneva Cancer Registry, Institute for Social and Preventive Medicine, University of Geneva; Department of Community, Occupational and Family Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vinh-Hung', 'Affiliation': 'Geneva Cancer Registry, Institute for Social and Preventive Medicine, University of Geneva; Oncology Center, Universitair Zienkenhuis, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp341']
3393,19940012,A phase I study of axitinib (AG-013736) in combination with bevacizumab plus chemotherapy or chemotherapy alone in patients with metastatic colorectal cancer and other solid tumors.,"BACKGROUND


Axitinib and bevacizumab are targeted therapies against the vascular endothelial growth factor pathway.
METHODS


Patients with previously treated solid tumors received axitinib (starting dose 5 mg twice daily) combined with FOLFOX plus bevacizumab (1, 2, or 5 mg/kg, cohorts 1-3, respectively), FOLFIRI (cohort 4), or FOLFOX (cohort 5). Safety and pharmacokinetics were assessed.
RESULTS


Thirty patients were enrolled (n = 16, 8, and 6 for cohorts 1-3, 4, and 5, respectively). Plasma concentrations and pharmacokinetic (PK) parameters were similar when drugs were administered alone and in various combinations. Most treatment-emergent adverse events (AEs) were mild to moderate and clinically manageable (most common: nausea, fatigue, diarrhea, anorexia, hypertension). Two of the four patients receiving axitinib with FOLFOX plus 5 mg/kg bevacizumab experienced dose-limiting toxicity (DLT) of inability to resume treatment for 14 days following treatment interruption (associated AE: hypertension); the maximum tolerated dose of bevacizumab in this combination was 2 mg/kg. No DLTs occurred with axitinib plus FOLFIRI or FOLFOX. Ten patients had RECIST-confirmed partial tumor responses (objective response rate: 33.3%).
CONCLUSION


Axitinib is well tolerated in combination with FOLFOX, FOLFIRI, or FOLFOX plus 2 mg/kg bevacizumab. PK interactions appear to be absent.",2010,Plasma concentrations and pharmacokinetic (PK) parameters were similar when drugs were administered alone and in various combinations.,"['Thirty patients were enrolled (n = 16, 8, and 6 for cohorts 1-3, 4, and 5, respectively', 'Patients with previously treated solid tumors received', 'patients with metastatic colorectal cancer and other solid tumors']","['axitinib (starting dose 5 mg twice daily) combined with FOLFOX plus bevacizumab', 'FOLFOX', 'axitinib (AG-013736', 'bevacizumab', 'bevacizumab plus chemotherapy or chemotherapy alone', 'FOLFOX, FOLFIRI, or FOLFOX', 'axitinib with FOLFOX plus 5 mg/kg bevacizumab']","['Safety and pharmacokinetics', 'Plasma concentrations and pharmacokinetic (PK) parameters', 'nausea, fatigue, diarrhea, anorexia, hypertension']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1328149', 'cui_str': 'AG013736'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",30.0,0.103002,Plasma concentrations and pharmacokinetic (PK) parameters were similar when drugs were administered alone and in various combinations.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Section of Gastrointestinal Oncology, Nevada Cancer Institute, Las Vegas, NV. Electronic address: sunil.sharma@hci.utah.edu.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Abhyankar', 'Affiliation': 'Department of Internal Medicine, Eastern Carolina Internal Medicine, Pollocksville, NC.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Burgess', 'Affiliation': 'Department of Internal Medicine, Eastern Carolina Internal Medicine, Pollocksville, NC.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Infante', 'Affiliation': 'Drug Development and Gastrointestinal Cancer Research, Sarah Cannon Research Institute, Nashville, TN.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Trowbridge', 'Affiliation': 'Indiana Oncology Hematology Consultants, St Francis Cancer Care Center, Indianapolis, IN.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tarazi', 'Affiliation': 'Oncology Development, Pfizer, San Diego, CA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Oncology Development, Pfizer, San Diego, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tortorici', 'Affiliation': 'Oncology Development, Pfizer, San Diego, CA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Oncology Development, Pfizer, San Diego, CA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Robles', 'Affiliation': 'Bay Area Cancer Research Group, Department of Medical Oncology and Hematology, Concord, CA, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp489']
3394,19625343,N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group (NCCTG) Trial.,"BACKGROUND


Because of the single-agent activity of irinotecan hydrochloride, combination of irinotecan and docetaxel treatment against metastatic breast cancer (MBC) should be evaluated.
PATIENTS AND METHODS


Single-stage phase 2 study of irinotecan and docetaxel to evaluate tumor response, toxicity, time to progression, and overall survival was carried out. Regimen of docetaxel (25 mg/m(2)) and irinotecan (70 mg/m(2)) was administered on days 1 and 8 of each 3-week cycle. Patients had histologically confirmed breast adenocarcinoma and metastatic cancer measurable with RECIST.
RESULTS


Of 70 patients enrolled, 64 were assessable. Prior treatment with an anthracycline and a taxane was required. Eighteen (28%) patients [95% confidence interval (CI) 15% to 31%] had tumor response, plus four patients had stable disease (less than 30% decrease in sum of longest diameter and less than 20% increase) for >6 months. The clinical benefit rate was 34% overall. Median duration of tumor response was 6.7 months (95% CI 4.2-37.7 months); median follow-up was 18.6 months (range 8.5-37.7 months). The most common severe adverse events included fatigue [n = 16 (25%)] and neutropenia [n = 13 (20%)].
CONCLUSIONS


Weekly dosing of combination of irinotecan and docetaxel is active against MBC. However, the response rate to our regimen was not significantly better than single-agent docetaxel. Other schedules of irinotecan plus docetaxel should be considered for future studies.",2010,Median duration of tumor response was 6.7 months (95% CI 4.2-37.7 months); median follow-up was 18.6 months (range 8.5-37.7 months).,"['Single-stage phase 2 study of', 'metastatic breast cancer (MBC', 'refractory metastatic breast cancer', '70 patients enrolled', 'Patients had histologically confirmed breast adenocarcinoma and metastatic cancer measurable with RECIST']","['irinotecan hydrochloride and docetaxel', 'anthracycline and a taxane', 'irinotecan plus docetaxel', 'docetaxel', 'irinotecan and docetaxel', 'irinotecan hydrochloride, combination of irinotecan and docetaxel', 'irinotecan']","['tumor response, toxicity, time to progression, and overall survival', 'clinical benefit rate', 'tumor response', 'stable disease', 'neutropenia', 'response rate', 'Median duration of tumor response']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0858252', 'cui_str': 'Breast adenocarcinoma'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0594375', 'cui_str': 'Irinotecan hydrochloride'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",70.0,0.0365776,Median duration of tumor response was 6.7 months (95% CI 4.2-37.7 months); median follow-up was 18.6 months (range 8.5-37.7 months).,"[{'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Tan', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Jacksonville, FL. Electronic address: tan.winston@mayo.edu.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Division of Biostatistics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Salim', 'Affiliation': 'Division of Hematology and Oncology, Allan Blair Cancer Center, Regina, Saskatchewan, Canada.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Division of Hematology and Oncology, Abbott Northwestern Hospital, Minneapolis, MN.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Stella', 'Affiliation': 'Department of Hematology and Oncology, Michigan Cancer Research Consortium, Ann Arbor, MI.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Niedringhaus', 'Affiliation': 'Department of Hematology and Oncology, Duluth CCOP, Duluth, MN.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Bernath', 'Affiliation': 'Department of Hematology and Oncology, Geisinger Clinic and Medical Center, Danville, PA.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Gamini', 'Affiliation': 'Department of Hematology and Oncology, Missouri Valley Cancer Consortium, Omaha, NE, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Palmieri', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Jacksonville, FL.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp328']
3395,32005286,Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda.,"BACKGROUND


There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in stabilised neonates; however, data on its effect among neonates before stabilisation are lacking. The OMWaNA trial aims to determine the effect of initiating KMC before stabilisation on mortality within seven days relative to standard care. Secondary objectives include exploring pathways for the intervention's effects and assessing incremental costs and cost-effectiveness between arms.
METHODS


We will conduct a four-centre, open-label, individually randomised, superiority trial in Uganda with two parallel groups: an intervention arm allocated to receive KMC and a control arm receiving standard care. We will enrol 2188 neonates (1094 per arm) for whom the indication for KMC is 'uncertain', defined as receiving ≥ 1 therapy (e.g. oxygen). Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥ 1 baby) weighing ≥ 700-≤ 2000 g and aged ≥ 1-< 48 h are eligible. Treatment allocation is random in a 1:1 ratio between groups, stratified by weight and recruitment site. The primary outcome is mortality within seven days. Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days. Primary analyses will be by intention-to-treat. Quantitative and qualitative data will be integrated in a process evaluation. Cost data will be collected and used in economic modelling.
DISCUSSION


The OMWaNA trial aims to assess the effectiveness of KMC in reducing mortality among neonates before stabilisation, a vulnerable population for whom its benefits are uncertain. The trial will improve understanding of pathways underlying the intervention's effects and will be among the first to rigorously compare the incremental cost and cost-effectiveness of KMC relative to standard care. The findings are expected to have broad applicability to hospitals in sub-Saharan Africa and southern Asia, where three-quarters of global newborn deaths occur, as well as important policy and programme implications.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02811432. Registered on 23 June 2016.",2020,"Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days.","['low birth Weight Neonates in Africa (OMWaNA', 'g and aged ≥', 'Uganda', 'Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥\u20091 baby) weighing ≥\u2009700-≤\u20092000', ""2188 neonates (1094 per arm) for whom the indication for KMC is 'uncertain', defined as receiving ≥\u20091 therapy (e.g. oxygen""]","['kangaroo mother care (KMC', 'Operationalising kangaroo Mother care before stabilisation', 'KMC and a control arm receiving standard care', 'KMC']","[""mortality within 28\u2009days, hypothermia prevalence at 24\u2009h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing"", 'mortality within seven\u2009days', 'incremental costs and cost-effectiveness between arms']","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",2188.0,0.257338,"Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days.","[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Medvedev', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Melissa.Morgan@lshtm.ac.uk.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tumukunde', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Mambule', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Cally J', 'Initials': 'CJ', 'LastName': 'Tann', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Waiswa', 'Affiliation': 'Centre of Excellence for Maternal, Newborn, and Child Health, School of Public Health, Makerere University, New Mulago Hill Road, Kampala, Uganda.'}, {'ForeName': 'Ruth R', 'Initials': 'RR', 'LastName': 'Canter', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ekirapa-Kiracho', 'Affiliation': 'Centre of Excellence for Maternal, Newborn, and Child Health, School of Public Health, Makerere University, New Mulago Hill Road, Kampala, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Katumba', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Pitt', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1E 7HT, UK.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Greco', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brotherton', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Moffat', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Joy E', 'Initials': 'JE', 'LastName': 'Lawn', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",Trials,['10.1186/s13063-019-4044-6']
3396,32005093,Pain-Free Versus Pain-Threshold Rehabilitation Following Acute Hamstring Strain Injury: A Randomized Controlled Trial.,"OBJECTIVE


The primary aim was to compare time from acute hamstring strain injury (HSI) to return-to-play (RTP) clearance following a standardized rehabilitation protocol performed within either pain-free or pain-threshold limits. Secondary aims were to compare isometric knee flexor strength, biceps femoris long head (BFLH) fascicle length, fear of movement, and reinjury occurrence at the 6-month follow-up between pain-free and pain-threshold groups.
DESIGN


Randomized controlled trial.
METHODS


Forty-three men with acute HSIs were randomly allocated to a pain-free (n = 22) or pain-threshold (n = 21) rehabilitation group. Days from HSI to RTP clearance, isometric knee flexor strength, BFLH fascicle length, fear of movement, and reinjury occurrence at the 6-month follow-up were reported.
RESULTS


Median time from HSI to RTP clearance was 15 days (95% confidence interval [CI]: 13, 17) in the pain-free group and 17 days (95% CI: 11, 24) in the pain-threshold group, which was not significantly different ( P  = .37). Isometric knee flexor strength recovery at 90° of hip and 90° of knee flexion was greater in the pain-threshold group at RTP clearance by 15% (95% CI: 1%, 28%) and by 15% (95% CI: 1%, 29%) at 2-month follow-up, respectively. Improvement in BFLH fascicle length from baseline was 0.91 cm (95% CI: 0.34, 1.48) greater at 2-month follow-up in the pain-threshold group. Two reinjuries occurred in both the pain-free and pain-threshold groups between RTP clearance and the 6-month follow-up.
CONCLUSION


Pain-threshold rehabilitation did not accelerate RTP clearance, but resulted in greater recovery of isometric knee flexor strength and better maintenance of BFLH fascicle length, compared to pain-free rehabilitation.  J Orthop Sports Phys Ther 2020;50(2):91-103. Epub 28 Jun 2019. doi:10.2519/jospt.2020.8895 .",2020,"Pain-threshold rehabilitation did not accelerate RTP clearance, but resulted in greater recovery of isometric knee flexor strength and better maintenance of BFLH fascicle length, compared to pain-free rehabilitation.  ","['Forty-three men with acute HSIs', 'Acute Hamstring Strain Injury']","['acute hamstring strain injury (HSI) to return-to-play (RTP) clearance', 'Pain-Free Versus Pain-Threshold Rehabilitation', 'J Orthop Sports', 'pain-threshold (n = 21) rehabilitation group']","['isometric knee flexor strength and better maintenance of BFLH fascicle length', 'isometric knee flexor strength, biceps femoris long head (BFLH) fascicle length, fear of movement, and reinjury occurrence at the 6-month follow-up between pain-free and pain-threshold groups', 'pain-free and pain', 'knee flexion', 'BFLH fascicle length', 'Isometric knee flexor strength recovery', 'RTP clearance, isometric knee flexor strength, BFLH fascicle length, fear of movement, and reinjury occurrence', 'Median time from HSI to RTP clearance']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",43.0,0.113345,"Pain-threshold rehabilitation did not accelerate RTP clearance, but resulted in greater recovery of isometric knee flexor strength and better maintenance of BFLH fascicle length, compared to pain-free rehabilitation.  ","[{'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Timmins', 'Affiliation': ''}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Maniar', 'Affiliation': ''}, {'ForeName': 'Ebonie', 'Initials': 'E', 'LastName': 'Rio', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Pitcher', 'Affiliation': ''}, {'ForeName': 'Morgan D', 'Initials': 'MD', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Opar', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.8895']
3397,32006422,"The Impact of High Dietary Sodium Consumption on Blood Pressure Variability in Healthy, Young Adults.","BACKGROUND


High sodium (Na+) intake augments blood pressure variability (BPV) in normotensive rodents, without changes in resting blood pressure (BP). Augmented BPV is associated with end-organ damage and cardiovascular morbidity. It is unknown if changes in dietary Na+ influence BPV in humans. We tested the hypothesis that high Na+ feeding would augment BPV in healthy adults.
METHODS


Twenty-one participants (10 F/11 M; 26 ± 5 years; BP: 113 ± 11/62 ± 7 mm Hg) underwent a randomized, controlled feeding study that consisted of 10 days of low (2.6 g/day), medium (6.0 g/day), and high (18.0 g/day) salt diets. On the ninth day of each diet, 24-h urine samples were collected and BPV was calculated from 24-h ambulatory BP monitoring. On the tenth day, in-laboratory beat-to-beat BPV was calculated during 10 min of rest. Serum electrolytes were assessed. We calculated average real variability (ARV) and standard deviation (SD) as metrics of BPV. As a secondary analysis, we calculated central BPV from the 24-h ambulatory BP monitoring.
RESULTS


24-h urinary Na+ excretion (low = 41 ± 24, medium = 97 ± 43, high = 265 ± 92 mmol/24 h, P < 0.01) and serum Na+ (low = 140.0 ± 2.1, medium = 140.7 ± 2.7, high = 141.7 ± 2.5 mmol/l, P = 0.009) increased with greater salt intake. 24-h ambulatory ARV (systolic BP ARV: low = 9.5 ± 1.7, medium = 9.5 ± 1.2, high = 10.0 ± 1.9 mm Hg, P = 0.37) and beat-to-beat ARV (systolic BP ARV: low = 2.1 ± 0.6, medium = 2.0 ± 0.4, high = 2.2 ± 0.8 mm Hg, P = 0.46) were not different. 24-h ambulatory SD (systolic BP: P = 0.29) and beat-to-beat SD (systolic BP: P = 0.47) were not different. There was a trend for a main effect of the diet (P = 0.08) for 24-h ambulatory central systolic BPV.
CONCLUSIONS


Ten days of high sodium feeding does not augment peripheral BPV in healthy, adults.
CLINICAL TRIALS REGISTRATION


NCT02881515.",2020,"There was a trend for a main effect of the diet (P=0.08) for 24-hour ambulatory central systolic BPV.
","['normotensive rodents', 'Healthy, Young Adults', 'healthy adults', 'humans', 'Twenty-one participants (10F/11M; 26±5 years; BP:113±11/62±7 mmHg', 'healthy, adults']","['High sodium (Na+) intake', 'High Dietary Sodium Consumption', 'Na+ feeding']","['resting blood pressure (BP', 'peripheral BPV', '24-hour ambulatory ARV (systolic BP ARV', 'Serum electrolytes', 'Blood Pressure Variability', 'blood pressure variability (BPV', '24-hour ambulatory SD (systolic BP: P=0.29) and beat-to-beat SD (systolic BP', '24-hour ambulatory central systolic BPV', 'serum Na', '24-hour urinary Na+ excretion', 'beat-to-beat ARV (systolic BP ARV', 'average real variability (ARV) and standard deviation (SD) as metrics of BPV']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement (procedure)'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",21.0,0.0346906,"There was a trend for a main effect of the diet (P=0.08) for 24-hour ambulatory central systolic BPV.
","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Wenner', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Stocker', 'Affiliation': 'Department of Medicine, Division of Renal-Electrolyte, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa014']
3398,31606288,Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial.,"INTRODUCTION


The ability of breast magnetic resonance imaging (MRI) to predict pathologic complete response (pCR) to neoadjuvant systemic therapy (NST) varies across biological subtypes. We sought to determine how well breast MRI findings following initial treatment on the phase III BrighTNess trial correlated with pCR in patients with triple negative breast cancer (TNBC).
METHODS


Baseline and mid-treatment imaging and pathologic response data were available in 519 patients with stage II-III TNBC who underwent NST as per protocol. MRI complete response (mCR) was defined as disappearance of all target lesion(s) and MRI partial response (mPR) as a ≥50% reduction in the largest tumor diameter.
RESULTS


Overall, mCR was demonstrated in 116 patients (22%), whereas 166 (32%) had mPR and 237 (46%) had stable/progressive disease (SD/PD). The positive predictive value (PPV), negative predictive value, and overall accuracy of the mid-treatment MRI for pCR were 78%, 56%, and 61%, respectively; accuracy did not differ significantly between gBRCA mutation carriers and non-carriers (52% vs. 63%, p = 0.10). When compared to patients with SD/PD, those with mPR or mCR were 3.35-fold (95% CI 2.07-5.41) more likely to have pCR at surgery. MRI response during NST was significantly associated with eligibility for breast-conserving surgery following completion of treatment (93.1% for mCR vs. 81.6% for SD/PD, p < 0.001).
CONCLUSIONS


Complete response on mid-treatment MRI in the BrighTNess trial had a PPV of 78% for demonstration of pCR after completion of NST in TNBC. However, a substantial proportion of patients with mPR or SD/PD also achieved a pCR.
CLINICAL TRIAL REGISTRATION


NCT02032277.",2020,"MRI response during NST was significantly associated with eligibility for breast-conserving surgery following completion of treatment (93.1% for mCR vs. 81.6% for SD/PD, p < 0.001).
","['patients with triple negative breast cancer (TNBC', '519 patients with stage II-III TNBC who underwent', 'triple-negative breast cancer']","['NST', 'neoadjuvant chemotherapy', 'neoadjuvant systemic therapy (NST', 'breast magnetic resonance imaging (MRI', 'magnetic resonance imaging']","['MRI response', 'MRI complete response (mCR', 'positive predictive value (PPV), negative predictive value, and overall accuracy of the mid-treatment MRI for pCR', 'disappearance of all target lesion(s) and MRI partial response (mPR', 'stable/progressive disease (SD/PD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",519.0,0.128186,"MRI response during NST was significantly associated with eligibility for breast-conserving surgery following completion of treatment (93.1% for mCR vs. 81.6% for SD/PD, p < 0.001).
","[{'ForeName': 'Mehra', 'Initials': 'M', 'LastName': 'Golshan', 'Affiliation': ""Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA; Breast Oncology Program, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA. Electronic address: mgolshan@bwh.harvard.edu.""}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Wong', 'Affiliation': 'McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Jens Bodo', 'Initials': 'JB', 'LastName': 'Huober', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Texas Oncology-Baylor Sammons Cancer Center/U.S. Oncology, Dallas, TX, USA.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation and Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Metzger-Filho', 'Affiliation': ""Breast Oncology Program, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Von Minckwitz', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation and Virginia Commonwealth University Massey Cancer Center, Richmond, VA, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Sikov', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Klinikum Berlin-Buch, Berlin, Germany.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.10.002']
3399,31718254,Phase II/III Study of Lisdexamfetamine Dimesylate in Japanese Pediatric Patients with Attention-Deficit/Hyperactivity Disorder.,"Objective:  To further define the efficacy and safety profiles of lisdexamfetamine dimesylate (LDX) in Japanese pediatric patients with attention-deficit/hyperactivity disorder (ADHD).  Methods:  This was a multicenter, randomized, double-blind, placebo-controlled study of LDX 30, 50, or 70 mg/day for 4 weeks in 76 patients 6-17 years of age with ADHD in Japan. The primary efficacy endpoint was the change in the ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to 4 weeks. Secondary efficacy endpoints were: Conners' Third Edition (Japanese version) Parent Rating Scale (Conners 3), Clinical Global Impression-Improvement (CGI-I) scale, and Parent Global Assessment (PGA) scale.  Results:  Change in the ADHD-RS-IV total score from baseline to 4 weeks was significantly greater ( p  < 0.0001) in all LDX dosage groups versus placebo (30 mg, -16.38; 50 mg, -18.10; 70 mg, -16.47; placebo, -2.78). At all time points, improvements (decreases) in the ADHD-RS-IV total score were significantly greater in all LDX groups versus placebo. At weeks 3 and 4, improvements from baseline in Conners 3 inattention plus hyperactivity/impulsivity subscale scores were significantly greater ( p  ≤ 0.0082) for all LDX dosages versus placebo. At week 4, the proportion of LDX-treated patients ""much improved"" or ""very much improved"" was 61%-71% on the CGI-I scale ( p  ≤ 0.0019) and 56%-65% on the PGA scale ( p  ≤ 0.0170). LDX was generally well tolerated. The most frequent treatment-emergent adverse events (AEs) were decreased appetite, headache, and initial insomnia. No severe/serious AEs occurred, and no AEs specific to Japanese patients were evident.  Conclusions:  The superiority of LDX 30, 50, and 70 mg/day over placebo was confirmed in Japanese pediatric patients with ADHD, and no major safety or tolerability concerns were identified.",2020,"At weeks 3 and 4, improvements from baseline in Conners 3 inattention plus hyperactivity/impulsivity subscale scores were significantly greater ( p  ≤ 0.0082) for all LDX dosages versus placebo.","['Japanese pediatric patients with ADHD', 'Japanese pediatric patients with attention-deficit/hyperactivity disorder (ADHD', '76 patients 6-17 years of age with ADHD in Japan', 'Japanese Pediatric Patients with Attention-Deficit/Hyperactivity Disorder']","['Lisdexamfetamine Dimesylate', 'placebo', 'LDX', 'lisdexamfetamine dimesylate (LDX']","['tolerated', 'PGA scale', 'change in the ADHD Rating Scale-IV (ADHD-RS-IV) total score', 'ADHD-RS-IV total score', 'severe/serious AEs', 'Conners 3 inattention plus hyperactivity/impulsivity subscale scores', 'appetite, headache, and initial insomnia', 'efficacy and safety profiles', 'Parent Rating Scale (Conners 3), Clinical Global Impression-Improvement (CGI-I) scale, and Parent Global Assessment (PGA) scale', ""Conners' Third Edition (Japanese version""]","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C1739826', 'cui_str': 'lisdexamfetamine dimesylate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0393760', 'cui_str': 'Initial insomnia (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",76.0,0.0485812,"At weeks 3 and 4, improvements from baseline in Conners 3 inattention plus hyperactivity/impulsivity subscale scores were significantly greater ( p  ≤ 0.0082) for all LDX dosages versus placebo.","[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Ichikawa', 'Affiliation': 'Japan Developmental Disorders Network, Tokyo, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Miyajima', 'Affiliation': 'Department of Education for Childcare, Tokyo Kasei University, Saitama, Japan.'}, {'ForeName': 'Yushiro', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Pediatrics and Child Health, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Biostatistics Center, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Akimasa', 'Initials': 'A', 'LastName': 'Fukushi', 'Affiliation': 'Clinical Research Department, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Aiiku Counseling Office, Aiiku Research Institute, Imperial Gift Foundation Boshi-Aiiku-Kai, Tokyo, Japan.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0076']
3400,31612630,Intradialytic exercise with blood flow restriction: Something to add to hemodialysis adequacy? Findings from a crossover study.,"INTRODUCTION


Hemodialysis (HD) increases the lifespan of chronic kidney disease (CKD) patients. However, HD is only partially effective in replacing renal function. The aim of this study is to compare HD adequacy between sessions with intradialytic exercise with or without blood flow restriction (BFR) with sessions without exercise.
METHODS


A crossover study including 22 adult CKD patients on HD. The patients were assigned to BFR (n = 11) or exercise alone group (n = 11). Each patient was submitted to four HD sessions (two with exercise and two control sessions). HD adequacy was assessed by equilibrated Kt/V-urea (eKT/V), single-pool Kt/V-urea (sp-Kt/V), urea and phosphorus rebound, urea reduction ratio (URR) and removal of urea and phosphorus in dialysate.
FINDINGS


BFR exercise improved eKt/V and sp-Kt/V (1.32 ± 0.21 vs. 1.10 ± 0.16 for control, P < 0.001; 1.53 ± 0.26 vs. 1.27 ± 0.19 for control, P < 0.001, respectively) and URR (72.5 ± 5.4% vs. 66.1 ± 7.7% for control, P < 0.001). No difference in eKt/V, sp-Kt/V or URR could be detected between exercise alone and control HD sessions. Urea rebound was lower in BFR exercise vs. control sessions (-8.9 ± 9.1% vs. 30.7 ± 12.8%, P < 0.01) and exercise alone vs. control sessions (13.3 ± 29.0% vs. 42.4 ± 15.3%, P < 0.01). Phosphorus rebound was marginally lower in exercise vs. control sessions (14.4 ± 19.1% vs. 28.4 ± 22.1%, P = 0.18). Urea and phosphorus mass removal in dialysate were marginally higher in exercise vs. control sessions (42.2 ± 19.4 g vs. 35.7 ± 12.5 g, P = 0.24; 912.1 ± 360.9 mg vs. 778.6 ± 245.1 mg, P = 0.28).
CONCLUSIONS


Intradialytic exercise with BFR was more effective than standard exercise in increasing HD adequacy.",2020,"No difference in eKt/V, sp-Kt/V or URR could be detected between exercise alone and control HD sessions.","['chronic kidney disease (CKD) patients', '22 adult CKD patients on HD']","['standard exercise', 'Hemodialysis (HD', 'intradialytic exercise with or without blood flow restriction (BFR) with sessions without exercise', 'Intradialytic exercise with blood flow restriction', 'BFR', 'exercise alone']","['urea and phosphorus rebound, urea reduction ratio (URR) and removal of urea and phosphorus in dialysate', 'URR', 'Urea and phosphorus mass removal in dialysate', 'BFR exercise improved eKt/V and sp-Kt/V', 'eKt/V, sp-Kt/V or URR', 'Urea rebound', 'Phosphorus rebound', 'HD adequacy']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0429664', 'cui_str': 'Urea reduction ratio (observable entity)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}]",,0.014608,"No difference in eKt/V, sp-Kt/V or URR could be detected between exercise alone and control HD sessions.","[{'ForeName': 'Etiene C', 'Initials': 'EC', 'LastName': 'Dias', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Orcy', 'Affiliation': 'Physiology Department, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Antunes', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Kohn', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Airton J', 'Initials': 'AJ', 'LastName': 'Rombaldi', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Ribeiro', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Oses', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Ferreira', 'Affiliation': 'Physiology Department, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Aline M', 'Initials': 'AM', 'LastName': 'Araújo', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Isis F', 'Initials': 'IF', 'LastName': 'Boff', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Maristela', 'Initials': 'M', 'LastName': 'Böhlke', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12793']
3401,30795031,Quadrangular Fixation of Pectus Bars to Prevent Displacement in Nuss Procedure.,"BACKGROUND


Double pectus bars are sometimes inserted to correct pectus excavatum. Method of double-bar fixation to prevent bar displacement has been rarely reported. We have used quadrangular fixation of the double pectus bars. The objective of this study was to compare results of the quadrangular fixation procedure with those of the classic separate fixation procedure.
METHODS


From September 2011 to January 2016, 86 patients underwent Nuss procedure with double-bar insertion. In 44 patients, each bar was fixed separately (group A). In 42 patients, quadrangular fixation of the bars was performed with metal plates (group B). Patient demographics, Haller index (HI), bar displacement index (BDI), and reoperation rate were compared between the two groups.
RESULTS


The mean patient age was 17.2 years (range: 3-40 years) in group A and 17.8 years (range: 4-30 years) in group B. There was no significant difference in preoperative or postoperative HIs between the two groups (all  p  >0.05). Early complication rates were 15.9% in group A and 9.5% in group B ( p  > 0.05). In group A, three patients underwent surgery to correct bar displacement (6.8% of reoperation rate), whereas there was no corrective surgery in group B. BDIs of the two groups were significantly different ( p  < 0.01).
CONCLUSIONS


When quadrangular fixation was performed with upper and lower pectus bars bilaterally fixed by connecting each bar with plates, bar displacement was prevented more effectively than separate fixation, thus minimizing reoperation.",2020,Early complication rates were 15.9% in group A and 9.5% in group B ( p  > 0.05).,"['From September 2011 to January 2016, 86 patients underwent Nuss procedure with double-bar insertion', 'mean patient age was 17.2 years (range: 3-40 years) in group A and 17.8 years (range: 4-30 years) in group']",['quadrangular fixation procedure'],"['preoperative or postoperative HIs', 'Early complication rates', 'Patient demographics, Haller index (HI), bar displacement index (BDI), and reoperation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205118', 'cui_str': 'Quadrangular (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231243', 'cui_str': 'Early complication (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}]",86.0,0.0424128,Early complication rates were 15.9% in group A and 9.5% in group B ( p  > 0.05).,"[{'ForeName': 'Gyeol', 'Initials': 'G', 'LastName': 'Yoo', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jeonghwan', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Rha', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jin Yong', 'Initials': 'JY', 'LastName': 'Jeong', 'Affiliation': ""Department of Thoracic and Cardiovascular Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ""Department of Thoracic and Cardiovascular Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Giyong', 'Initials': 'G', 'LastName': 'Noh', 'Affiliation': ""Department of Anesthesiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Soo Seog', 'Initials': 'SS', 'LastName': 'Park', 'Affiliation': ""Department of Anesthesiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0039-1678695']
3402,31991017,Novel modified Peyton's approach for knowledge retention on newborn life support training in medical students.,"AIM


We sought to improve retention of neonatal resuscitation skills by modifying step 3 through additional functional verbalisation in Peyton's four-step approach (P4S).
METHODS


Newborn life support (NLS) training was performed in a simulation-based setting. In contrast to the traditional approach, students taught with the modified approach were requested to explain every step of their performance in Peyton's step 3. A total of 123 students were allocated into both experimental groups. Students were then assessed by megacode on day four (initial assessment) and 6 months (follow-up assessment).
RESULTS


Both groups showed similar scorings in the initial, follow-up assessment and in mean change. On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group. All showed a significant loss of performance irrespective of modification in step 3 in the follow-up assessment. Only time until start with post-resuscitation care shows a significant group difference in mean change between initial and follow-up with increasing time in the control and decreasing time span in intervention group.
CONCLUSION


Both methods showed equal levels of knowledge acquisition and long-term decline in NLS performances. Verbalisation in step 3 influenced speed of applied NLS performance.",2020,"On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group.","['123 Students', 'medical students']","['Novel modified Peyton approach', 'Newborn life support (NLS) training']","['speed of applied NLS performance', 'equal levels of knowledge acquisition and long-term decline in NLS performances', 'time span']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",123.0,0.013784,"On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group.","[{'ForeName': 'Nasenien', 'Initials': 'N', 'LastName': 'Nourkami-Tutdibi', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Hilleke', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wagenpfeil', 'Affiliation': 'Saarland University Medical Center, Institute of Medical Biometry, Epidemiology and Medical Informatics, Homburg, Germany.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Tutdibi', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15198']
3403,31988711,"The effect of a single spinal manipulation on cardiovascular autonomic activity and the relationship to pressure pain threshold: a randomized, cross-over, sham-controlled trial.","Background


The autonomic nervous system interacts with the pain system. Knowledge on the effects of high velocity low amplitude spinal manipulations (SM) on autonomic activity and experimentally induced pain is limited. In particular, the effects of SM on autonomic activity and pain beyond the immediate post intervention period as well as the relationship between these two outcomes are understudied. Thus, new research is needed to provide further insight on this issue.
Objectives


The aim was to assess the effect of a single SM (i.e. SM vs. sham) on cardiovascular autonomic activity. Also, we assessed the relationship between cardiovascular autonomic activity and level of pain threshold after the interventions.
Method


We conducted a randomized, cross-over, sham-controlled trial on healthy first-year chiropractic students comprising two experimental sessions separated by 48 h. During each session, subjects received, in a random order, either a thoracic SM or a sham manipulation. Cardiovascular autonomic activity was assessed using heart rate and systolic blood pressure variabilities. Pain sensitivity was assessed using pressure pain threshold. Measurements were performed at baseline and repeated three times (every 12 min) during the post intervention period. Participants and outcome assessors were blinded. The effect of the SM was tested with linear mixed models. The relationship between autonomic outcomes and pressure pain threshold was tested with bivariate correlations.
Results


Fifty-one participants were included, forty-one were finally analyzed. We found no statistically significant difference between SM and sham in cardiovascular autonomic activity post intervention. Similarly, we found no post-intervention relationship between cardiovascular autonomic activity and pressure pain threshold.
Conclusion


Our results suggest that a single SM of the thoracic spine has no specific effect on cardiovascular autonomic activity. Also, we found no relationship between cardiovascular autonomic activity and pressure pain threshold after the SM. Further experimental research should consider the use of several markers of autonomic activity and a more comprehensive pain assessment.
Trial registration


N° NCT03273868. Registered September 6, 2017.",2020,We found no statistically significant difference between SM and sham in cardiovascular autonomic activity post intervention.,"['healthy first-year chiropractic students comprising two experimental sessions separated by 48\u2009h', 'Fifty-one participants were included, forty-one were finally analyzed']","['thoracic SM or a sham manipulation', 'high velocity low amplitude spinal manipulations (SM', 'single spinal manipulation', 'SM', 'single SM']","['heart rate and systolic blood pressure variabilities', 'Cardiovascular autonomic activity', 'cardiovascular autonomic activity and level of pain threshold', 'Pain sensitivity', 'cardiovascular autonomic activity and pressure pain threshold', 'cardiovascular autonomic activity', 'cardiovascular autonomic activity and pressure pain', 'autonomic activity and pain']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",51.0,0.0981695,We found no statistically significant difference between SM and sham in cardiovascular autonomic activity post intervention.,"[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Picchiottino', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Honoré', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gagey', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Cottin', 'Affiliation': '1Université Paris-Saclay CIAMS, 91405 Orsay, France.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hallman', 'Affiliation': '5Centre for Musculoskeletal Research, Department of Occupational and Public Health Sciences, University of Gävle, Gävle, Sweden.'}]",Chiropractic & manual therapies,['10.1186/s12998-019-0293-4']
3404,31992344,"Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol.","INTRODUCTION


Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population.
METHODS


This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient.
DISCUSSION


The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018.
DISCLAIMER


The views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication.
ROLES AND RESPONSIBILITIES


AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.",2020,"Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs.","['individuals with CNLBP who have not had surgery', 'patients with CNLBP who have not had surgery', '96 patients with CNLBP who have not had spinal surgery', 'patients with failed back surgery syndrome (FBSS', 'chronic neuropathic low back pain (MODULATE-LBP']","['10\u2009khz high-frequency spinal cord stimulation', 'kHz SCS plus usual care (intervention group) or to sham 10\u2009kHz SCS plus usual care (control group) after receiving the full implant', 'kHz spinal cord stimulation (SCS', '10\u2009kHz SCS']","['pain and improves health-related quality of life', 'Oswestry Disability Index, complications, EQ-5D-5\u2009L, and health and social care costs', '7-day daily pain diary', 'Incremental cost per quality-adjusted life year (QALY']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}]","[{'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0451366', 'cui_str': 'Pain diary (assessment scale)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",96.0,0.486461,"Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs.","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Al-Kaisy', 'Affiliation': ""Pain Management & Neuromodulation Centre, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH, London, UK. alkaisy@aol.com.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Royds', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Palmisani', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wesley', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health and Well Being, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'Wessex Institute, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Duarte', 'Affiliation': 'Liverpool Reviews and Implementation Group, Health Services Research, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Fairbank', 'Affiliation': 'University of Oxford, Oxford, UK.'}]",Trials,['10.1186/s13063-019-3831-4']
3405,32001530,Outcomes after late bone marrow and very early central nervous system relapse of childhood B-Acute lymphoblastic leukemia: a report from the Children's Oncology Group phase III study AALL0433.,"Outcomes after relapse of childhood B-acute lymphoblastic leukemia (B-ALL) are poor, and optimal therapy is unclear. Children's Oncology Group study AALL0433 evaluated a new platform for relapsed ALL. Between March 2007 and October 2013 AALL0433 enrolled 275 participants with late bone marrow or very early isolated central nervous system (iCNS) relapse of childhood B-ALL. Patients were randomized to receive standard versus intensive vincristine dosing; this randomization closed due to excess peripheral neuropathy in 2010. Patients with matched sibling donors received allogeneic hematopoietic cell transplantation (HCT) after the first three blocks of therapy. The prognostic value of minimal residual disease (MRD) was also evaluated in this study. The 3-year event free and overall survival (EFS/OS) for the 271 eligible patients were 63.6% +/- 3.0% and 72.3% +/- 2.8% respectively. MRD at the end of Induction-1 was highly predictive of outcome, with 3-year EFS/OS of 84.9 +/- 4.0% and 93.8 +/- 2.7% for patients with MRD <0.1%, vs. 53.7 +/- 7.8% and 60.6 +/- 7.8% for patients with MRD ≥0.1% (p<0.0001). Patients who received HCT vs. chemotherapy alone had an improved 3-year disease-free survival (77.5 +/- 6.2% vs. 66.9 +/- 4.5%, p=0.03) but not OS (81.5 +/- 5.8% for HCT vs. 85.8 +/- 3.4% for chemotherapy, p=0.46). Patients with early iCNS relapse fared poorly, with a 3-year EFS/OS of 41.4% +/- 9.2% and 51.7% +/- 9.3%, respectively. Infectious toxicities of the chemotherapy platform were significant. The AALL0433 chemotherapy platform is efficacious for late bone marrow relapse of B-ALL, but with significant toxicities. The MRD threshold of 0.1% at the end of Induction-1 was highly predictive of outcome. The optimal role for HCT for this patient population remains uncertain. This trial is registered at clinicaltrials.gov (NCT# 00381680).",2020,"MRD at the end of Induction-1 was highly predictive of outcome, with 3-year EFS/OS of 84.9 +/-","['Between March 2007 and October 2013 AALL0433 enrolled 275 participants with late bone marrow or very early isolated central nervous system (iCNS) relapse of childhood B-ALL', '271 eligible patients were 63.6% ', 'childhood B-Acute lymphoblastic leukemia', ""Children's Oncology Group study""]","['HCT', 'standard versus intensive vincristine', 'HCT vs. chemotherapy', 'allogeneic hematopoietic cell transplantation (HCT']","['MRD', '3-year disease-free survival', '3-year event free and overall survival (EFS/OS', 'Infectious toxicities']","[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",275.0,0.0535966,"MRD at the end of Induction-1 was highly predictive of outcome, with 3-year EFS/OS of 84.9 +/-","[{'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Lew', 'Affiliation': ""Emory University / Children's Healthcare of Atlanta; glen.lew@choa.org.""}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""St. Jude Children's Research Hospital.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Gilead Sciences, Inc.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Rheingold', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Whitlock', 'Affiliation': 'Hospital for Sick Children.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""St. Jude Children's Research Hospital.""}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Hastings', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'NYU Langone Medical Center.'}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Johns Hopkins Medical Institutions.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Pulsipher', 'Affiliation': ""Children's Hospital Los Angeles, USC Keck School of Medicine.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Children's Hospital of Philadelphia.""}]",Haematologica,['10.3324/haematol.2019.237230']
3406,31340611,Postprandial Effects of a Proprietary Milk Protein Hydrolysate Containing Bioactive Peptides in Prediabetic Subjects.,"Milk proteins have been hypothesized to protect against type 2 diabetes (T2DM) by beneficially modulating glycemic response, predominantly in the postprandial status. This potential is, amongst others, attributed to the high content of whey proteins, which are commonly a product of cheese production. However, native whey has received substantial attention due to its higher leucine content, and its postprandial glycemic effect has not been assessed thus far in prediabetes. In the present study, the impact of a milk protein hydrolysate of native whey origin with alpha-glucosidase inhibiting properties was determined in prediabetics in a randomized, cross-over trial. Subjects received a single dose of placebo or low- or high-dosed milk protein hydrolysate prior to a challenge meal high in carbohydrates. Concentration-time curves of glucose and insulin were assessed. Incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by low-dosed milk peptides compared to placebo ( p  = 0.0472), and a minor insulinotropic effect was seen. A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA 1c  values ( p  = 0.0244). In conclusion, the current milk protein hydrolysate of native whey origin has the potential to modulate postprandial hyperglycemia and hence may contribute in reducing the future risk of developing T2DM.",2019,A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA 1c  values ( p  = 0.0244).,['Prediabetic Subjects'],"['milk protein hydrolysate', 'placebo or low- or high-dosed milk protein hydrolysate', 'Proprietary Milk Protein Hydrolysate Containing Bioactive Peptides', 'placebo']","['insulinotropic effect', 'glucose response', 'Incremental areas under the curve (iAUC) of glucose', 'Concentration-time curves of glucose and insulin']",[],"[{'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.0162403,A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA 1c  values ( p  = 0.0244).,"[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sartorius', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Weidner', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Tanita', 'Initials': 'T', 'LastName': 'Dharsono', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Boulier', 'Affiliation': 'Ingredia S.A., 51 Avenue F. Lobbedez CS 60946, 62033 Arras CEDEX, France.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Mathematics, Natural and Economic Sciences, Ulm University of Applied Sciences, Albert-Einstein-Allee 55, 89081 Ulm, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Schön', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany. c.schoen@biotesys.de.'}]",Nutrients,['10.3390/nu11071700']
3407,30224341,"MAVERICC, a Randomized, Biomarker-stratified, Phase II Study of mFOLFOX6-Bevacizumab versus FOLFIRI-Bevacizumab as First-line Chemotherapy in Metastatic Colorectal Cancer.","PURPOSE


MAVERICC compared the efficacy and safety of modified leucovorin/5-fluorouracil/oxaliplatin plus bevacizumab (mFOLFOX6-BV) with leucovorin/5-fluorouracil/irinotecan plus bevacizumab (FOLFIRI-BV) in patients with previously untreated metastatic colorectal cancer (mCRC). Patients and Methods:  MAVERICC was a global, randomized, open-label, phase II study. Primary objectives were to assess associations between (i) excision repair cross-complementing 1 (ERCC1) expression with progression-free survival (PFS), and (ii) plasma VEGF A (VEGF-A) with PFS in patients with previously untreated mCRC receiving mFOLFOX6-BV or FOLFIRI-BV. Before randomization, patients were stratified by tumoral ERCC1/β-actin mRNA expression level and region.
RESULTS


Of 376 enrolled patients, 188 each received mFOLFOX6-BV and FOLFIRI-BV. PFS and overall survival (OS) were comparable between FOLFIRI-BV and mFOLFOX6-BV, with numerically higher PFS [HR = 0.79; 95% CI (confidence interval): 0.61-1.01;  P  = 0.06] and OS (HR = 0.76; 95% CI: 0.56-1.04;  P  = 0.09) observed for FOLFIRI-BV. In the high ERCC1 subgroup, PFS and OS were comparable between treatment groups (PFS, HR = 0.84; 95% CI: 0.56-1.26;  P  = 0.40; OS, HR = 0.80; 95% CI: 0.51-1.26;  P  = 0.33). Across treatment groups, high plasma VEGF-A levels (>5.1 pg/mL) were observed with shorter PFS (HR = 1.19; 95% CI: 0.93-1.53;  P  = 0.17) and significantly shorter OS (HR = 1.64; 95% CI: 1.20-2.24;  P  < 0.01) versus low levels (≤5.1 pg/mL). Safety findings for FOLFIRI-BV or mFOLFOX6-BV were comparable with those reported previously.
CONCLUSIONS


First-line FOLFIRI-BV and mFOLFOX6-BV had comparable PFS and OS, similar to results in patients with high baseline tumor ERCC1 levels. There were no new safety signals with these bevacizumab-containing regimens.",2019,"PFS and overall survival (OS) were comparable between FOLFIRI-BV and mFOLFOX6-BV, with numerically higher PFS [HR = 0.79; 95% CI (confidence interval): 0.61-1.01;  P  = 0.06] and OS (HR = 0.76; 95% CI: 0.56-1.04;  P  = 0.09) observed for FOLFIRI-BV.","['376 enrolled patients, 188', 'Metastatic Colorectal Cancer', 'patients with previously untreated mCRC receiving mFOLFOX6-BV or FOLFIRI-BV', 'patients with previously untreated metastatic colorectal cancer (mCRC']","['modified leucovorin/5-fluorouracil/oxaliplatin plus bevacizumab (mFOLFOX6-BV) with leucovorin/5-fluorouracil/irinotecan plus bevacizumab (FOLFIRI-BV', 'mFOLFOX6-Bevacizumab versus FOLFIRI-Bevacizumab', 'bevacizumab']","['PFS and overall survival (OS', 'associations between (i) excision repair cross-complementing 1 (ERCC1) expression with progression-free survival (PFS), and (ii) plasma VEGF A (VEGF-A) with PFS', 'high plasma VEGF-A levels', 'PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0015249', 'cui_str': 'Excision Repair'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0009499', 'cui_str': 'Complement C1'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",376.0,0.218652,"PFS and overall survival (OS) were comparable between FOLFIRI-BV and mFOLFOX6-BV, with numerically higher PFS [HR = 0.79; 95% CI (confidence interval): 0.61-1.01;  P  = 0.06] and OS (HR = 0.76; 95% CI: 0.56-1.04;  P  = 0.09) observed for FOLFIRI-BV.","[{'ForeName': 'Aparna R', 'Initials': 'AR', 'LastName': 'Parikh', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital, Boston, Massachusetts. Aparna.Parikh@MGH.HARVARD.EDU.'}, {'ForeName': 'Fa-Chyi', 'Initials': 'FC', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology/Oncology, University of California Irvine, Irvine, California.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Yau', 'Affiliation': 'Evidence Generation, Biometrics, Genentech, Inc., US Medical Affairs, South San Francisco, California.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Koh', 'Affiliation': 'Department of Medical Oncology, Southern California Permanente Group, Bellflower, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Knost', 'Affiliation': 'Department of Hematology/Oncology, Illinois Cancer Center, Peoria, Illinois.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bosanac', 'Affiliation': 'Global Product Development Medical Affairs-PDMA, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Choong', 'Affiliation': 'Genentech, Inc., US Medical Affairs, South San Francisco, California.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Scappaticci', 'Affiliation': 'BioOncology, Genentech, Inc., US Medical Affairs, South San Francisco, California.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mancao', 'Affiliation': 'Oncology Biomarker Development, Genentech Inc., Basel, Switzerland.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Norris Comprehensive Cancer Center, Keck School of Medicine, Department of Medicine, University of Southern California, Los Angeles, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-1221']
3408,31203097,Blood eosinophil count and GOLD stage predict response to maintenance azithromycin treatment in COPD patients with frequent exacerbations.,"INTRODUCTION


Maintenance treatment with macrolides are useful in preventing COPD exacerbations. We investigated which characteristics of COPD patients with frequent exacerbations predicted the best response to maintenance treatment with azithromycin.
METHODS


This study was part of the COLUMBUS trial, a prospective randomized, double-blind, placebo-controlled study in 92 COPD patients with frequent exacerbations. During the 1-year treatment period, follow-up data were collected for spirometry, mMRC scores, sputum cultures and blood inflammatory markers.
RESULTS


In the azithromycin group a significant lower number of exacerbations per patient was observed in patients with the following characteristics: baseline blood eosinophil count ≥2.0% (x̄ = 1.26), compared to an eosinophil count < 2.0% (x̄ = 2.50; p = 0.02), GOLD stage 1-2 (x̄ = 1.06), versus GOLD stage 4 (x̄ = 2.62; p = 0.02) and GOLD group C (x̄ = 0.45) compared to group D (x̄ = 2.18; p < 0.01). Moreover, the number of hospitalizations was significantly lower in patients, with a blood eosinophil count ≥2.0% (x̄ = 0.26) compared to an eosinophil count < 2.0% (x̄ = 0.90; p = 0.01) and in GOLD stages 1-2 (x̄ = 1.06) compared to stage 4 (x̄ = 2.62; p = 0.04).
CONCLUSION


In conclusion, azithromycin maintenance treatment appears to be effective in COPD patients with frequent exacerbations, who are either classified in GOLD stage 1-2 or GOLD C and those with a blood eosinophil count of ≥2.0%.",2019,"Moreover, the number of hospitalizations was significantly lower in patients, with a blood eosinophil count ≥2.0% (x̄ = 0.26) compared to an eosinophil count < 2.0% (x̄ = 0.90; p = 0.01) and in GOLD stages 1-2 (x̄ = 1.06) compared to stage 4 (x̄ = 2.62;","['COPD patients with frequent exacerbations', '92 COPD patients with frequent exacerbations']","['azithromycin maintenance', 'azithromycin', 'placebo']","['number of exacerbations per patient', 'Blood eosinophil count and GOLD stage predict response', 'baseline blood eosinophil count', 'spirometry, mMRC scores, sputum cultures and blood inflammatory markers', 'number of hospitalizations']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",92.0,0.0980646,"Moreover, the number of hospitalizations was significantly lower in patients, with a blood eosinophil count ≥2.0% (x̄ = 0.26) compared to an eosinophil count < 2.0% (x̄ = 0.90; p = 0.01) and in GOLD stages 1-2 (x̄ = 1.06) compared to stage 4 (x̄ = 2.62;","[{'ForeName': 'Remco S', 'Initials': 'RS', 'LastName': 'Djamin', 'Affiliation': 'Department of Respiratory Medicine, Amphia Hospital, Breda, the Netherlands. Electronic address: m.vandereerden@erasmusmc.nl.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bafadhel', 'Affiliation': 'Department of Respiratory Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Uzun', 'Affiliation': 'Department of Respiratory Medicine, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Richard E K', 'Initials': 'REK', 'LastName': 'Russell', 'Affiliation': 'Department of Respiratory Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Anton A M', 'Initials': 'AAM', 'LastName': 'Ermens', 'Affiliation': 'Laboratory for Clinical Chemistry and Haematology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Kerstens', 'Affiliation': 'Consulting Biostatistician, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Respiratory Medicine, Amphia Hospital, Breda, the Netherlands; Department of Respiratory Medicine, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Department of Respiratory Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Menno M', 'Initials': 'MM', 'LastName': 'van der Eerden', 'Affiliation': 'Department of Respiratory Medicine, Erasmus Medical Centre, Rotterdam, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2019.06.005']
3409,31493111,Opioids and analgesics use after adult spinal deformity surgery correlates with sagittal alignment and preoperative analgesic pattern.,"PURPOSE


To assess pain, health-related quality of life (HRQOL) scores and sagittal parameters of adult spinal deformity (ASD)-operated patients in the context of their analgesic consumption especially opioids (narcotics) over the first year postoperative period.
METHODS


In total, 372 patients from a multicenter database were stratified into 3 groups at baseline: 241 patients in the minimal group (no analgesic, or NSAIDs/narcotics weekly or less), 64 in the NSAIDs every day group and 67 in the narcotics every day group. HRQOL and back and leg pain scores were evaluated at 6 months and 1 year postoperatively. Also several sagittal alignment parameters were assessed.
RESULTS


Significant improvements in pain and HRQOL scores were observed across all 3 groups by 1 year (P < 0.05) postoperatively. While the minimal group had the best pre- and postoperative HRQOL scores, the NSAID group demonstrated the best improvement in HRQOL. Only the minimal group displayed continued improvement from 6 months to 1 year. 90%, 65% and 40% of minimal, NSAID and narcotic groups of patients, respectively, no longer took any analgesics at 1 year postoperatively. Alternatively, 36% of patients in the narcotics group continued to take narcotics at 1 year. Residual malalignment increased NSAIDs consumption in different groups at 1 year.
CONCLUSION


This study evaluated the analgesics use after ASD surgery in relation to the clinical and radiological outcomes. Despite important postoperative opioids consumption in the narcotics group, clinical outcome yet improved. Malalignment parameters demonstrated a predictive value in regard to NSAIDs' usage. These slides can be retrieved under Electronic Supplementary Material.",2020,"RESULTS


Significant improvements in pain and HRQOL scores were observed across all 3 groups by 1 year (P < 0.05) postoperatively.","['372 patients from a multicenter database were stratified into 3 groups at baseline: 241 patients in the minimal group (no analgesic, or NSAIDs/narcotics weekly or less), 64 in the NSAIDs every day group and 67 in the narcotics every day group', 'adult spinal deformity surgery correlates with sagittal alignment and preoperative analgesic pattern']",[],"['NSAIDs consumption', 'pain, health-related quality of life (HRQOL) scores and sagittal parameters of adult spinal deformity', 'pre- and postoperative HRQOL scores', 'HRQOL and back and leg pain scores', 'HRQOL', 'pain and HRQOL scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",[],"[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}]",372.0,0.0335021,"RESULTS


Significant improvements in pain and HRQOL scores were observed across all 3 groups by 1 year (P < 0.05) postoperatively.","[{'ForeName': 'Anouar', 'Initials': 'A', 'LastName': 'Bourghli', 'Affiliation': 'Orthopedic and Spinal Surgery Department, Kingdom Hospital, P.O. Box 84400, Riyadh, 11671, Saudi Arabia. anouar.bourghli@gmail.com.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Boissiere', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Larrieu', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Kaissar', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Cawley', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujishiro', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kieser', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gille', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Vital', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Alanay', 'Affiliation': 'Spine Surgery Unit, Acibadem Maslak Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Pellisé', 'Affiliation': 'Spine Surgery Unit, Hospital Universitario Val Hebron, Barcelona, Spain.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Acaroglu', 'Affiliation': 'Ankara Acibadem Spine Center, Ankara, Turkey.'}, {'ForeName': 'Francisco-Javier', 'Initials': 'FJ', 'LastName': 'Perez-Grueso', 'Affiliation': 'Spine Surgery Unit, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Kleinstück', 'Affiliation': 'Spine Center, Schulthess Klinik, Zurich, Switzerland.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Obeid', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Bordeaux Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06141-8']
3410,31961418,Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial.,"Importance


It is not known if use of colloid solutions containing hydroxyethyl starch (HES) to correct for intravascular deficits in high-risk surgical patients is either effective or safe.
Objective


To evaluate the effect of HES 130/0.4 compared with 0.9% saline for intravascular volume expansion on mortality and postoperative complications after major abdominal surgery.
Design, Setting, and Participants


Multicenter, double-blind, parallel-group, randomized clinical trial of 775 adult patients at increased risk of postoperative kidney injury undergoing major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow-up was in October 2018.
Interventions


Patients were randomized to receive fluid containing either 6% HES 130/0.4 diluted in 0.9% saline (n = 389) or 0.9% saline alone (n = 386) in 250-mL boluses using an individualized hemodynamic algorithm during surgery and for up to 24 hours on the first postoperative day, defined as ending at 7:59 am the following day.
Main Outcomes and Measures


The primary outcome was a composite of death or major postoperative complications at 14 days after surgery. Secondary outcomes included predefined postoperative complications within 14 days after surgery, durations of intensive care unit and hospital stays, and all-cause mortality at postoperative days 28 and 90.
Results


Among 826 patients enrolled (mean age, 68 [SD, 7] years; 91 women [12%]), 775 (94%) completed the trial. The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, -3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33). Among 12 prespecified secondary outcomes reported, 11 showed no significant difference, but a statistically significant difference was found in median volume of study fluid administered on day 1: 1250 mL (interquartile range, 750-2000 mL) in the HES group and 1500 mL (interquartile range, 750-2150 mL) in the saline group (median difference, 250 mL [95% CI, 83-417 mL]; P = .006). At 28 days after surgery, 4.1% and 2.3% of patients had died in the HES and saline groups, respectively (difference, 1.8% [95% CI, -0.7% to 4.3%]; relative risk, 1.76 [95% CI, 0.79-3.94]; P = .17).
Conclusions and Relevance


Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery. These findings do not support the use of HES for volume replacement therapy in such patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT02502773.",2020,"The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, -3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33).","['826 patients enrolled (mean age', 'after major abdominal surgery', 'Undergoing Major Abdominal Surgery', '775 adult patients at increased risk of postoperative kidney injury undergoing major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow-up was in October 2018', '68 [SD, 7] years; 91 women [12%]), 775 (94%) completed the trial', 'High-Risk Patients', 'patients at risk of postoperative kidney injury undergoing major abdominal surgery']","['Hydroxyethyl Starch vs Saline', 'colloid solutions containing hydroxyethyl starch (HES', 'fluid containing either 6% HES 130/0.4 diluted in 0.9% saline (n\u2009=\u2009389) or 0.9% saline alone (n\u2009=\u2009386) in 250-mL boluses using an individualized hemodynamic algorithm', 'HES']","['mortality and postoperative complications', 'Death or Postoperative Complications', 'postoperative complications within 14 days after surgery, durations of intensive care unit and hospital stays, and all-cause mortality at postoperative days 28 and 90', 'composite outcome of death or major postoperative complications', 'median volume of study fluid', 'composite of death or major postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002045'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",775.0,0.683203,"The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, -3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33).","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Département Anesthésie et Réanimation, Hôpital Estaing, Université Clermont Auvergne, CNRS, Inserm U-1103, Clermont-Ferrand, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Garot', 'Affiliation': 'CHU de Lille, Pôle Anesthésie Réanimation, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Godet', 'Affiliation': 'CHU de Clermont-Ferrand, Département Anesthésie et Réanimation, Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Biais', 'Affiliation': 'CHU de Bordeaux, Département Anesthésie et Réanimation, Hôpital Pellegrin, Bordeaux, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Verzilli', 'Affiliation': 'CHU Montpellier, Département Anesthésie et Réanimation B (DAR B), Hôpital Saint-Eloi, and Inserm U-1046, Montpellier, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Ouattara', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation, Centre Medico-chirugical Magellan, Bordeaux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huet', 'Affiliation': 'CHU de Brest, Département Anesthésie et Réanimation, Hôpital La cavale Blanche, Brest, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lescot', 'Affiliation': 'Fresenius Kabi, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lebuffe', 'Affiliation': 'CHU de Lille, Pôle Anesthésie Réanimation, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dewitte', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation, Centre Medico-chirugical Magellan, Bordeaux, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cadic', 'Affiliation': 'CHU de Brest, Département Anesthésie et Réanimation, Hôpital La cavale Blanche, Brest, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Restoux', 'Affiliation': 'AP-HP, Département Anesthésie et Réanimation, Hôpital Beaujon, Clichy, Paris, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'CHU de Nantes, Département Anesthésie et Réanimation, Hôpital Hôtel Dieu, Nantes, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Paugam-Burtz', 'Affiliation': 'AP-HP, Département Anesthésie et Réanimation, Hôpital Beaujon, Clichy, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': ""CHU de Nîmes, Section d'Anesthésie, Département Anesthésie et Réanimation, Nîmes, France.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Faucher', 'Affiliation': 'Institut Paoli Calmettes, Département Anesthésie et Réanimation, Marseille, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Vaisse', 'Affiliation': 'Assistance Publique Hôpitaux de Marseille (AP-HM), Service Anesthésie et Réanimation, Hôpital Timone, Marseille, France.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'El Amine', 'Affiliation': 'Centre Hospitalier de Valenciennes, Département Anesthésie et Réanimation, Valenciennes, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Beloeil', 'Affiliation': 'Université de Rennes, Inserm, INRA, CHU Rennes, CIC 1414, Numecan, Pôle Anesthésie et Réanimation, Rennes, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Leone', 'Affiliation': 'AP-HM, Service Anesthésie et Réanimation, Hôpital Nord, Université Aix Marseille, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Noll', 'Affiliation': ""Hôpitaux Universitaires de Strasbourg, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Hautepierre, Strasbourg, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piriou', 'Affiliation': ""Université Claude Bernard Lyon 1, Hospices Civils de Lyon, Service d'Anesthésie Réanimation, Centre Hospitalier Lyon Sud, Lyon, France.""}, {'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': 'Département Anesthésie et Réanimation, CHU Angers, Angers, France.'}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': 'CHU de Clermont-Ferrand, Département Anesthésie et Réanimation, Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics Unit, Direction de la Recherche Clinique (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'CHU Montpellier, Département Anesthésie et Réanimation B (DAR B), Hôpital Saint-Eloi, and Inserm U-1046, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Sigismond', 'Initials': '', 'LastName': 'Lasocki', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': '', 'LastName': 'Huet', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': '', 'LastName': 'Cadic', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': '', 'LastName': 'Jacob', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': '', 'LastName': 'Paugam-Burtz', 'Affiliation': ''}, {'ForeName': 'Aymeric', 'Initials': '', 'LastName': 'Restoux', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': '', 'LastName': 'Ouattara', 'Affiliation': ''}, {'ForeName': 'Ioana', 'Initials': '', 'LastName': 'Feitita', 'Affiliation': ''}, {'ForeName': 'Elsa', 'Initials': '', 'LastName': 'Deloge', 'Affiliation': ''}, {'ForeName': 'Mylène', 'Initials': '', 'LastName': 'Defaye', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': '', 'LastName': 'Joannes-Boyau', 'Affiliation': ''}, {'ForeName': 'Pauline', 'Initials': '', 'LastName': 'Carles', 'Affiliation': ''}, {'ForeName': 'Guya', 'Initials': '', 'LastName': 'Napolitano', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': '', 'LastName': 'Monziols', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': '', 'LastName': 'Futier', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': '', 'LastName': 'Vignaud', 'Affiliation': ''}, {'ForeName': 'Solène', 'Initials': '', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': '', 'LastName': 'Gahbiche', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': '', 'LastName': 'Fayon', 'Affiliation': ''}, {'ForeName': 'Erwan', 'Initials': '', 'LastName': 'Laroche', 'Affiliation': ''}, {'ForeName': 'Jean-Etienne', 'Initials': '', 'LastName': 'Bazin', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': '', 'LastName': 'Brandely', 'Affiliation': ''}, {'ForeName': 'Charlene', 'Initials': '', 'LastName': 'Le Moal', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': '', 'LastName': 'Lebuffe', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': '', 'LastName': 'Garot', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': '', 'LastName': 'Piriou', 'Affiliation': ''}, {'ForeName': 'Samir', 'Initials': '', 'LastName': 'Jaber', 'Affiliation': ''}, {'ForeName': 'Gérald', 'Initials': '', 'LastName': 'Chanques', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': '', 'LastName': 'Verzilli', 'Affiliation': ''}, {'ForeName': 'Audrey', 'Initials': '', 'LastName': 'De Jong', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': '', 'LastName': 'Millot', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': '', 'LastName': 'Castagnoli', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': '', 'LastName': 'Leone', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': '', 'LastName': 'Pastene', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': '', 'LastName': 'Castelli', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': '', 'LastName': 'Medam', 'Affiliation': ''}, {'ForeName': 'Lionel', 'Initials': '', 'LastName': 'Velly', 'Affiliation': ''}, {'ForeName': 'Camille', 'Initials': '', 'LastName': 'Vaisse', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': '', 'LastName': 'Faucher', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': '', 'LastName': 'Asehnoune', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': '', 'LastName': 'Samba', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': '', 'LastName': 'Roquilly', 'Affiliation': ''}, {'ForeName': 'Marguerite', 'Initials': '', 'LastName': 'Le Penndu', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': '', 'LastName': 'Cuvillon', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': '', 'LastName': 'Yves Lefrant', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': '', 'LastName': 'Wira', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': '', 'LastName': 'Dubout', 'Affiliation': ''}, {'ForeName': 'Willy-Serge', 'Initials': '', 'LastName': 'Mfam', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Lescot', 'Affiliation': ''}, {'ForeName': 'Emilie', 'Initials': '', 'LastName': 'Begneu', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': '', 'LastName': 'Burey', 'Affiliation': ''}, {'ForeName': 'Teodora', 'Initials': '', 'LastName': 'Cirilovic', 'Affiliation': ''}, {'ForeName': 'Hélène', 'Initials': '', 'LastName': 'Beloeil', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': '', 'LastName': 'Allo', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': '', 'LastName': 'Pottecher', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': '', 'LastName': 'Lebas', 'Affiliation': ''}, {'ForeName': 'Clementine', 'Initials': '', 'LastName': 'Venot', 'Affiliation': ''}, {'ForeName': 'Jean Pierre', 'Initials': '', 'LastName': 'Rameau', 'Affiliation': ''}, {'ForeName': 'Florin', 'Initials': '', 'LastName': 'Dimache', 'Affiliation': ''}, {'ForeName': 'Pierre Saint', 'Initials': '', 'LastName': 'Léger', 'Affiliation': ''}, {'ForeName': 'Younes', 'Initials': '', 'LastName': 'El Amine', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.20833']
3411,31552537,No benefit of early versus late ambulation after incidental durotomy in lumbar spine surgery: a randomized controlled trial.,"PURPOSE


Incidental durotomy (ID) is a complication occurring in 4-17% of decompressive spinal surgeries. Persisting CSF leakage can occur even after ID repair and requires revision surgery. Prolonged flat bed rest (BR) to reduce the incidence of persisting CSF leakage is frequently applied but highly debated. A randomized controlled trial comparing prolonged BR versus early ambulation after ID repair is lacking. The aim of this study was to investigate the incidence of revision surgery as a result of persistent cerebro-spinal fluid (CSF) leakage and medical complications after immediate or late post-operative ambulation following ID during decompressive spinal surgery.
METHODS


Ninety-four of 1429 consecutive cases undergoing lumbar spine surgery (6.58%) were complicated by an ID. Sixty patients (mean age of 64 ± 13.28 years) were randomized to either early post-operative ambulation (EA, n = 30) or flat BR for 48 h (BR, n = 30). The incidence of CSF leakage resulting in revision surgery, medical complications and duration of hospitalization were compared between groups.
RESULTS


Two patients in the BR group and two patients in the EA group underwent revision surgery as a result of persisting CSF leakage. Four patients in the BR group experienced medical complications associated with prolonged immobilization. The duration of hospitalization was 7.25 ± 3.0 days in the BR group versus 6.56 ± 2.64 days in the EA group, p = 0.413.
CONCLUSION


The results of this study indicate no benefit of prolonged BR after an adequately repaired ID in lumbar spine surgery.
LEVEL OF EVIDENCE


Level 1b (individual randomized controlled trial). These slides can be retrieved under Electronic Supplementary Material.",2020,"The duration of hospitalization was 7.25 ± 3.0 days in the BR group versus 6.56 ± 2.64 days in the EA group, p = 0.413.
","['Sixty patients (mean age of 64\u2009±\u200913.28\xa0years', 'lumbar spine surgery', 'Ninety-four of 1429 consecutive cases undergoing lumbar spine surgery (6.58%) were complicated by an ID']","['early post-operative ambulation (EA, n\u2009=\u200930) or flat BR', 'Prolonged flat bed rest (BR']","['persisting CSF leakage', 'medical complications and duration of hospitalization', 'medical complications', 'CSF leakage', 'duration of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0023182', 'cui_str': 'Spinal Cerebrospinal Fluid Leak'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",1429.0,0.119818,"The duration of hospitalization was 7.25 ± 3.0 days in the BR group versus 6.56 ± 2.64 days in the EA group, p = 0.413.
","[{'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Farshad', 'Affiliation': 'University Spine Center Zurich, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland. mazda.farshad@balgrist.ch.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Aichmair', 'Affiliation': 'University Spine Center Zurich, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Wanivenhaus', 'Affiliation': 'University Spine Center Zurich, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Betz', 'Affiliation': 'University Spine Center Zurich, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Spirig', 'Affiliation': 'University Spine Center Zurich, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'David Ephraim', 'Initials': 'DE', 'LastName': 'Bauer', 'Affiliation': 'University Spine Center Zurich, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06144-5']
3412,30979733,Application of Artificial Intelligence for Preoperative Diagnostic and Prognostic Prediction in Epithelial Ovarian Cancer Based on Blood Biomarkers.,"PURPOSE


We aimed to develop an ovarian cancer-specific predictive framework for clinical stage, histotype, residual tumor burden, and prognosis using machine learning methods based on multiple biomarkers.
EXPERIMENTAL DESIGN


Overall, 334 patients with epithelial ovarian cancer (EOC) and 101 patients with benign ovarian tumors were randomly assigned to ""training"" and ""test"" cohorts. Seven supervised machine learning classifiers, including Gradient Boosting Machine (GBM), Support Vector Machine, Random Forest (RF), Conditional RF (CRF), Naïve Bayes, Neural Network, and Elastic Net, were used to derive diagnostic and prognostic information from 32 parameters commonly available from pretreatment peripheral blood tests and age.
RESULTS


Machine learning techniques were superior to conventional regression-based analyses in predicting multiple clinical parameters pertaining to EOC. Ensemble methods combining weak decision trees, such as GBM, RF, and CRF, showed the best performance in EOC prediction. The values for the highest accuracy and area under the ROC curve (AUC) for segregating EOC from benign ovarian tumors with RF were 92.4% and 0.968, respectively. The highest accuracy and AUC for predicting clinical stages with RF were 69.0% and 0.760, respectively. High-grade serous and mucinous histotypes of EOC could be preoperatively predicted with RF. An ordinal RF classifier could distinguish complete resection from others. Unsupervised clustering analysis identified subgroups among early-stage EOC patients with significantly worse survival.
CONCLUSIONS


Machine learning systems can provide critical diagnostic and prognostic prediction for patients with EOC before initial intervention, and the use of predictive algorithms may facilitate personalized treatment options through pretreatment stratification of patients.",2019,"Ensemble methods combining weak decision trees, such as GBM, RF, and CRF, showed the best performance in EOC prediction.","['Epithelial Ovarian Cancer Based on Blood Biomarkers', '334 patients with epithelial ovarian cancer (EOC) and 101 patients with benign ovarian tumors']","['Artificial Intelligence', 'Seven supervised machine learning classifiers, including Gradient Boosting Machine (GBM), Support Vector Machine, Random Forest (RF), Conditional RF (CRF), Naïve Bayes, Neural Network, and Elastic Net', 'training"" and ""test"" cohorts']","['highest accuracy and area under the ROC curve (AUC', 'survival']","[{'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004997', 'cui_str': 'Benign neoplasm of ovary (disorder)'}]","[{'cui': 'C0003916', 'cui_str': 'AI (Artificial Intelligence)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4042903', 'cui_str': 'Supervised Machine Learning'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0086312', 'cui_str': 'Forestlands'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",334.0,0.0451795,"Ensemble methods combining weak decision trees, such as GBM, RF, and CRF, showed the best performance in EOC prediction.","[{'ForeName': 'Eiryo', 'Initials': 'E', 'LastName': 'Kawakami', 'Affiliation': 'Medical Sciences Innovation Hub Program, RIKEN, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Tabata', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Yanaihara', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan. yanazou@jikei.ac.jp.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Medical Sciences Innovation Hub Program, RIKEN, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Koseki', 'Affiliation': 'Medical Sciences Innovation Hub Program, RIKEN, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Iida', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Misato', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Komazaki', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Shapiro', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Goto', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Akiyama', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Hirokuni', 'Initials': 'H', 'LastName': 'Takano', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Aikou', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3378']
3413,31993665,"Age and time-of-day differences in the hypothalamo-pituitary-testicular, and adrenal, response to total overnight sleep deprivation.","STUDY OBJECTIVES


In young men, sleep restriction decreases testosterone (Te) and increases afternoon cortisol (F), leading to anabolic-catabolic imbalance, insulin resistance, and other andrological health consequences. Age-related differences in the hypothalamo-pituitary-testicular/adrenal response to sleep restriction could expose older individuals to greater or lesser risk. We aimed to evaluate and compare the 24-h and time-of-day effect of sleep restriction on F, luteinizing hormone (LH), and Te in young and older men.
METHODS


Thirty-five healthy men, aged 18-30 (n = 17) and 60-80 (n =18) years, underwent overnight sleep deprivation (complete nighttime wakefulness) or nighttime sleep (10 pm to 6 am) with concurrent 10-min blood sampling in a prospectively randomized crossover study. F, LH, and Te secretion were calculated by deconvolution analysis.
RESULTS


Sleep deprivation had multiple effects on 24-h Te secretion with significant reductions in mean concentrations, basal, total and pulsatile secretion, and pulse frequency (each p < 0.05), in the absence of detectable changes in LH. These effects were most apparent in older men and differed according to age for some parameters: pulsatile Te secretion (p = 0.03) and Te pulse frequency (p = 0.02). Time-of-day analyses revealed that sleep restriction significantly reduced Te in the morning and afternoon, reduced LH in the morning in both age groups, and increased F in the afternoon in older men.
CONCLUSIONS


These data suggest a time-of-day dependent uncoupling of the regulatory control of the testicular axis and of F secretion. Future studies will need to directly verify these regulatory possibilities specifically and separately in young and older men.
CLINICAL TRIAL


Not applicable.",2020,These effects were most apparent in older men and differed according to age for some parameters: pulsatile Te secretion (P=0.03) and Te pulse frequency (P=0.02).,"['older men', 'Thirty-five healthy men, aged 18-30 (n=17) and 60-80 (n=18) years, underwent', 'young and older men']","['sleep restriction on F, luteinizing hormone (LH) and Te', 'overnight sleep deprivation (complete nighttime wakefulness) or nighttime sleep (10PM to 6AM) with concurrent 10-minute blood sampling']","['mean concentrations, basal, total and pulsatile secretion, and pulse frequency', 'F, LH and Te secretion', '24-hour Te secretion', 'sleep restriction decreases testosterone (Te) and increases afternoon cortisol (F), leading to anabolic-catabolic imbalance, insulin resistance, and other andrological health consequences']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",35.0,0.0246444,These effects were most apparent in older men and differed according to age for some parameters: pulsatile Te secretion (P=0.03) and Te pulse frequency (P=0.02).,"[{'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Takahashi', 'Affiliation': 'Department of Primary Care Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Iranmanesh', 'Affiliation': 'Endocrine Service, Salem Veterans Affairs Medical Center, Salem, VA.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, MN.'}]",Sleep,['10.1093/sleep/zsaa008']
3414,31346900,"Comparison between two mathematical methods to estimate arterial occlusion pressure and tourniquet effectiveness in lower limb surgery: a prospective, randomized, double blind, comparative study.","The effectiveness of two different methods for calculating the arterial occlusion pressure (AOP) to set tourniquet inflation pressures were assessed in patients underwent knee arthroscopy. Eighty patients were included in this study. Tourniquet inflation pressure was set by adding 20 mmHg of safety margin above the AOP value which was calculated by either the Tuncali et al. formula or Hong-yun Liu et al. formula. Primary outcome measures were the initial and maximum SBP, initial and maximum tourniquet inflation pressure, the secondary outcomes were the surgeon rating of the bloodlessness of the surgical field and tourniquet associated complications. There was significant difference in the initial tourniquet pressure (mmHg); it was 208 ± 12 and 262 ± 18 for group (A) and (B) respectively; also there was significant difference in the maximum tourniquet pressure (mmHg), it was 229 ± 14 and 283 ± 19 for group (A) and (B) respectively. There was no significant difference in the initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP between the groups. Also, there was no significant difference in surgeon rating of the bloodlessness of the surgical field, at the start, middle and end of surgery. Hong-yun Liu et al. mathematical formula was found to be less effective than Tuncali et al. formula to estimate the least effective tourniquet pressure in lower limb surgery and we might consider it invalid to be used in the lower limb.Clinical trials registration number: NCT03706859 (Clinicaltrials.gov) and registration date: January, 2019. https://clinicaltrials.gov/ct2/show/NCT03706859.",2020,"There was no significant difference in the initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP between the groups.","['lower limb surgery', 'Eighty patients were included in this study', 'patients underwent knee arthroscopy']",['formula or Hong-yun'],"['arterial occlusion pressure (AOP', 'initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP', 'maximum tourniquet pressure', 'Tourniquet inflation pressure', 'surgeon rating', 'initial tourniquet pressure', 'initial and maximum SBP, initial and maximum tourniquet inflation pressure, the secondary outcomes were the surgeon rating of the bloodlessness of the surgical field and tourniquet associated complications', 'arterial occlusion pressure and tourniquet effectiveness']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}]",[],"[{'cui': 'C0264995', 'cui_str': 'Occlusion of artery (disorder)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0428725', 'cui_str': 'Tourniquet inflation pressure (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",80.0,0.0620154,"There was no significant difference in the initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP between the groups.","[{'ForeName': 'Samaa A', 'Initials': 'SA', 'LastName': 'Kasem', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Beni Suef University, Street 10, Pyramids gardens, Giza, Egypt. sama.a.kasem@gmail.com.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Al Menesy', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Beni Suef University, Street 10, Pyramids gardens, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Badawy', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abd Elmawgoud', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Adel', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Yasmin A', 'Initials': 'YA', 'LastName': 'Badawy', 'Affiliation': 'Faculty of Medicine, Cairo University, Giza, Egypt.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00366-0']
3415,31994819,Need for pacing in patients who qualify for an implantable cardioverter-defibrillator: Clinical implications for the subcutaneous ICD.,"BACKGROUND


Implantation of the subcutaneous implantable cardioverter-defibrillator (S-ICD) is spreading and has been shown to be safe and effective; however, it does not provide brady-pacing. Currently, data on the need for brady-pacing and cardiac resynchronization therapy (CRT) implantation in patients with ICD indication are limited.
METHODS


The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II enrolled post-MI patients with reduced ejection fraction (EF ≤ 35%), randomized to either an implantable cardioverter-defibrillator (ICD) or conventional medical therapy. Kaplan-Meier analyses and multivariate Cox models were performed to assess the incidence and predictors of pacemaker (PM), or CRT implantation in the conventional arm of MADIT-II, after excluding 32 patients (6.5%) with a previously implanted PM.
RESULTS


During the median follow-up of 20 months, 24 of 458 patients (5.2%) were implanted with a PM or a CRT (19 PM, 5 CRT). Symptomatic sinus bradycardia was the primary indication for PM implantation (n = 9, 37%), followed by AV block (n = 5, 21%), tachy-brady syndrome (n = 4, 17%), and carotid sinus hypersensitivity (n = 1, 4%). Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation. Patients with PM/CRT implantation had a significantly higher risk for heart failure (HR = 2.67, 95% CI = 1.38-5.14, p = .003), but no increased mortality risk (HR = 1.06, 95% CI = 0.46-2.46, p = .89).
CONCLUSION


The short-term need for ventricular pacing or CRT implantation in patients with MADIT-II ICD indication was low, especially in those with a normal baseline PR interval, and such patients are appropriate candidates for the subcutaneous ICD.",2020,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","['patients with ICD', 'MI patients with reduced ejection fraction (EF\xa0≤\xa035', 'patients who qualify for an implantable cardioverter-defibrillator']","['ventricular pacing or CRT implantation', 'subcutaneous implantable cardioverter-defibrillator (S-ICD', 'cardiac resynchronization therapy (CRT) implantation', 'implantable cardioverter-defibrillator (ICD) or conventional medical therapy']","['incidence and predictors of pacemaker (PM), or CRT implantation', 'carotid sinus hypersensitivity', 'mortality risk', 'Symptomatic sinus bradycardia', 'risk for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0741983', 'cui_str': 'Carotid sinus hypersensitivity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0748712', 'cui_str': 'Symptomatic sinus bradycardia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",,0.084377,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Spencer Z', 'Initials': 'SZ', 'LastName': 'Rosero', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Brown', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12744']
3416,31998468,Analysis of Anesthesia Methods in Percutaneous Kyphoplasty for Treatment of Vertebral Compression Fractures.,"Aim


Percutaneous kyphoplasty (PKP) is a routine operation for the treatment of vertebral compression fracture (VCF). Both local anesthesia and general anesthesia are widely used for PKP. However, which type of anesthesia is better for PKP still remains uncertain. This study aimed to find out whether local anesthesia or general anesthesia is more suitable for PKP.
Methods


This is a retrospective clinical trial. A total of 85 single-level VCF patients who received PKP 12 months ago were recruited in this study. 45 patients who received local anesthesia were in group L, and 40 patients with general anesthesia were in group G. Clinical, radiological, and economic data between the two groups were collected.
Results


No difference was found on preoperative data between the two groups. The duration of operation time in group L was longer than that in group G. Within 12 months after PKP, more complications happened in group G than those in group L.
Results


No difference was found on preoperative data between the two groups. The duration of operation time in group L was longer than that in group G. Within 12 months after PKP, more complications happened in group G than those in group L.
Conclusion


Both local anesthesia and general anesthesia were reliable for PKP. However, local anesthesia was more efficient and safer with less expense and more bearable pain when compared with general anesthesia.",2020,"Within 12 months after PKP, more complications happened in group G than those in group L.
Results


No difference was found on preoperative data between the two groups.","['vertebral compression fracture (VCF', 'Vertebral Compression Fractures', 'A total of 85 single-level VCF patients who received PKP 12 months ago were recruited in this study', '40 patients with', '45 patients who received']","['local anesthesia or general anesthesia', 'general anesthesia', 'local anesthesia', 'Percutaneous kyphoplasty (PKP']","['bearable pain', 'duration of operation time']","[{'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",45.0,0.0158848,"Within 12 months after PKP, more complications happened in group G than those in group L.
Results


No difference was found on preoperative data between the two groups.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia, Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesia, Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'School of Software Technology, Dalian University of Technology, Dalian, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Software Technology, Dalian University of Technology, Dalian, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}]",Journal of healthcare engineering,['10.1155/2020/3965961']
3417,31996580,Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial.,"BACKGROUND


Methods of treatment of rectocele include transperineal, transvaginal, and transanal approaches and ventral rectopexy.
OBJECTIVE


The present randomized study aimed to compare the outcome of transperineal repair and transvaginal repair of anterior rectocele.
DESIGN


This is a randomized, single-blinded clinical trial.
SETTING


This study was conducted at the Colorectal Surgery Unit, Mansoura University Hospitals.
PATIENTS


Adult female patients with anterior rectocele reporting obstructed defecation syndrome were selected.
INTERVENTIONS


Anterior rectocele was surgically treated via a transperineal or transvaginal approach.
MAIN OUTCOME MEASURES


Improvement in constipation, operation time, hospital stay, complications, changes in anal pressures, and improvement in sexual-related quality of life was assessed by use of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the incidence of dyspareunia postoperatively was assessed.
RESULTS


Sixty-four female patients of a mean age of 43.5 years were entered into the trial. There was no significant difference between the 2 groups regarding the operation time. Patients undergoing transperineal repair had significantly longer hospital stays than those undergoing transvaginal repair (2.4 vs 2.1 days, p = 0.03). There was no significant difference between the 2 groups regarding postoperative complications and recurrence of rectocele. Significant decrease in the constipation scores was recorded in both groups at 6 and 12 months after surgery. The decrease in the constipation scores after transvaginal repair was significantly higher than after transperineal repair at 6 and 12 months postoperatively. Although resting and squeeze anal pressures were significantly increased at 12 months after transperineal repair, they did not show significant change after transvaginal repair. Improvement in sexual-related quality of life was significantly higher in the transvaginal repair group than in the transperineal repair group at 6 and 12 months after surgery. Dyspareunia improved after transvaginal repair and worsened after transperineal repair, yet this change was insignificant.
LIMITATIONS


This was a single-center study comprising a relatively small number of patients.
CONCLUSION


Transvaginal repair of rectocele achieved better improvement in constipation and sexual-related quality of life than transperineal repair. Changes in dyspareunia after both techniques were not significant. See Video Abstract at http://links.lww.com/DCR/B148.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03801291. RESULTADO FUNCIONAL Y CALIDAD DE VIDA RELACIONADA CON EL SEXO DESPUÉS DE LA REPARACIÓN TRANSPERINEAL VERSUS TRANSVAGINAL DEL RECTOCELE ANTERIOR: UN ENSAYO CLÍNICO ALEATORIZADO: Los métodos de tratamiento del rectocele incluyen los abordajes transperineal, transvaginal y transanal y la rectopexia ventral.El objetivo del presente estudio aleatorizado fue comparar el resultado de la reparación transperineal y la reparación transvaginal del rectocele anterior.Ensayo clínico aleatorizado, simple ciego.Unidad de Cirugía Colorrectal, Hospital Universitario de Mansoura.Pacientes mujeres adultas con rectocele anterior que se quejan de síndrome de defecación obstruida.Tratamiento quirúrgico del rectocele anterior mediante abordaje transperineal o transvaginal.Mejora en el estreñimiento, tiempo de operación, estancia hospitalaria, complicaciones, cambios en la presión anal, mejoría en la calidad de vida relacionada con el sexo evaluada por el cuestionario PISQ-12 e incidencia de dispareunia postoperatoria.Sesenta y cuatro pacientes de sexo femenino de una edad media de 43.5 años ingresaron al ensayo. No hubo diferencias significativas entre los dos grupos con respecto al tiempo de operación. La reparación transperineal tuvo una estancia hospitalaria significativamente más prolongada que la reparación transvaginal (2.4 Vs 2.1 días, p = 0.03). No hubo diferencias significativas entre ambos grupos con respecto a las complicaciones postoperatorias y la recurrencia del rectocele. Se registró una disminución significativa en las puntuaciones de estreñimiento en ambos grupos a los 6 y 12 meses después de la cirugía. La disminución en las puntuaciones de estreñimiento después de la reparación transvaginal fue significativamente mayor que después de la reparación transperineal a los 6 y 12 meses después de la operación. Aunque las presiones anales de reposo y compresión aumentaron significativamente a los 12 meses después de la reparación transperineal, no mostraron cambios significativos después de la reparación transvaginal. La mejora en la calidad de vida relacionada con el sexo fue significativamente mayor en la reparación transvaginal que en el grupo de reparación transperineal a los 6 y 12 meses después de la cirugía. La dispareunia mejoró después de la reparación transvaginal y empeoró después de la reparación transperineal, sin embargo, este cambio fue insignificante.Estudio de un solo centro que comprende un número relativamente pequeño de pacientes.La reparación transvaginal del rectocele logró una mejoría en el estreñimiento y la calidad de vida relacionada con el sexo que la reparación transperineal. Los cambios en la dispareunia después de ambas técnicas no fueron significativos. Consulte Video Resumen en http://links.lww.com/DCR/B148.Ensayos clínicos. Identificador del gobierno: NCT03801291.",2020,Improvement in sexual-related quality of life was significantly higher in the transvaginal repair than the transperineal repair group at 6 and 12 months after surgery.,"['Colorectal Surgery Unit, Mansoura University Hospitals', 'Adult female patients with anterior rectocele complaining of obstructed defecation syndrome', 'Single center study comprising relatively small number of patients', 'Sixty-four female patients of a mean age of 43.5 years']","['transperineal repair and transvaginal repair of anterior rectocele', 'Transperineal versus Transvaginal Repair of Anterior Rectocele', 'anterior rectocele via transperineal or transvaginal approach']","['constipation, operation time, hospital stay, complications, changes in anal pressures, improvement in sexual-related quality of life assessed by the PISQ-12 questionnaire, and incidence of dyspareunia postoperatively', 'constipation scores', 'operation time', 'Functional outcome and Sexual-Related Quality of Life', 'sexual-related quality of life', 'resting and squeeze anal pressures', 'postoperative complications and recurrence of rectocele', 'constipation and sexual-related quality of life', 'dyspareunia', 'longer hospital stay', 'Dyspareunia']","[{'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0149771', 'cui_str': 'Proctocele'}, {'cui': 'C0549186', 'cui_str': 'Obstructed (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0149771', 'cui_str': 'Proctocele'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0149771', 'cui_str': 'Proctocele'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",64.0,0.0437358,Improvement in sexual-related quality of life was significantly higher in the transvaginal repair than the transperineal repair group at 6 and 12 months after surgery.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Balata', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura University Hospitals, Mansoura University, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elgendy', 'Affiliation': ''}, {'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Youssef', 'Affiliation': ''}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Omar', 'Affiliation': ''}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khafagy', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001595']
3418,31998949,"Surface Perturbation Training to Prevent Falls in Older Adults: A Highly Pragmatic, Randomized Controlled Trial.","BACKGROUND


Falls are the leading cause of injuries among older adults, and trips and slips are major contributors to falls.
OBJECTIVE


The authors sought to compare the effectiveness of adding a component of surface perturbation training to usual gait/balance training for reducing falls and fall-related injury in high-risk older adults referred to physical therapy.
DESIGN


This was a multi-center, pragmatic, randomized, comparative effectiveness trial.
SETTING


Treatment took place within 8 outpatient physical therapy clinics.
PATIENTS


This study included 506 patients 65+ years of age at high fall risk referred for gait/balance training.
INTERVENTION


This trial evaluated surface perturbation treadmill training integrated into usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone.
MEASUREMENTS


Falls and injurious falls were assessed with a prospective daily fall diary, which was reviewed via telephone interview every 3 months for 1 year.A total of 211/253 (83%) patients randomized to perturbation training and 210/253 (83%) randomized to usual treatment provided data at 3-month follow-up. At 3 months, the perturbation training group had a significantly reduced chance of fall-related injury (5.7% versus 13.3%; relative risk 0.43) but no significant reduction in the risk of any fall (28% versus 37%, relative risk 0.78) compared with usual treatment. Time to first injurious fall showed reduced hazard in the first 3 months but no significant reduction when viewed over the entire first year.
LIMITATIONS


The limitations of this trial included lack of blinding and variable application of interventions across patients based on pragmatic study design.
CONCLUSION


The addition of some surface perturbation training to usual physical therapy significantly reduced injurious falls up to 3 months posttreatment. Further study is warranted to determine the optimal frequency, dose, progression, and duration of surface perturbation aimed at training postural responses for this population.",2020,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","['high-risk older adults', 'Older Adults', 'Treatment took place within 8 outpatient physical therapy clinics', '506 patients aged 65+ at high fall risk referred for gait/balance training']","['surface-perturbation training to usual gait/balance training', 'Surface Perturbation Training', ""usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone""]","['injurious falls', 'Falls and injurious falls', 'chance of fall-related injury']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",506.0,0.0271618,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","[{'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Lurie', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03781 (USA), and Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Zagaria', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Elliot Hospital Senior Health Center Rehabilitation, Manchester, New Hampshire.'}, {'ForeName': 'Dawna', 'Initials': 'D', 'LastName': 'Pidgeon', 'Affiliation': 'Dartmouth-Hitchcock Medical Center.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gill-Body', 'Affiliation': 'Newton-Wellesley Hospital, Newton, Massachusetts. Dr Gill-Body is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Burke', 'Affiliation': 'South Shore Neurologic Associates, Patchogue, New York. Dr Burke is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Armbrust', 'Affiliation': 'White River Junction Veterans Administration Hospital, White River Junction, Vermont.'}, {'ForeName': 'Sharil', 'Initials': 'S', 'LastName': 'Cass', 'Affiliation': 'Farnum Rehabilitation Center, Keene, New Hampshire.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Spratt', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'McDonough', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Physical therapy,['10.1093/ptj/pzaa023']
3419,31848294,"A Randomized Trial Comparing the Safety, Adherence, and Pharmacodynamics Profiles of Two Doses of Sodium Bicarbonate in CKD: the BASE Pilot Trial.","BACKGROUND


Oral sodium bicarbonate (NaHCO 3 ) may preserve kidney function in CKD, even if initiated when serum bicarbonate concentration is normal. Adequately powered trials testing this hypothesis have not been conducted, partly because the best dose for testing is unknown.
METHODS


This multicenter pilot trial assessed the safety, tolerability, adherence, and pharmacodynamics of two doses of NaHCO 3  over 28 weeks in adults with eGFR 20-44 or 45-59 ml/min per 1.73 m 2  with urinary albumin/creatinine (ACR) ≥50 mg/g and serum bicarbonate 20-28 meq/L. We randomly assigned 194 participants from ten clinical sites to receive higher-dose (HD-NaHCO 3 ; 0.8 meq/kg of lean body wt per day;  n =90) or lower-dose (LD-NaHCO 3 ; 0.5 meq/kg of lean body wt per day;  n =52) NaHCO 3  or matching placebo ( n =52). The dose was adjusted depending on side effects. The prescribed dose at week 28 was the primary outcome; a dose was considered acceptable for a full-scale trial if ≥67% of participants were on full-dose and ≥80% were on ≥25% of the per-protocol dose.
RESULTS


Mean±SD baseline eGFR was 36±9 ml/min per 1.73 m 2 , serum bicarbonate was 24±2 meq/L, and median (IQR) ACR was 181 (25-745) mg/g. Both doses were well tolerated without significant changes in BP, weight, or serum potassium. The proportions of adverse events and hospitalizations were similar across the groups. Consequently, 87% in HD-NaHCO 3 , 96% in LD-NaHCO 3 , and 87% in placebo were on full dose at week 28; and 91% in HD-NaHCO 3 , 98% in LD-NaHCO 3 , and 92% in placebo were on ≥25% of the per-protocol dose. Mean urinary ammonium excretion was 25% lower and serum bicarbonate concentration was 1.3 meq/L higher in HD-NaHCO 3  compared with LD-NaHCO 3  at week 28. However, mean ACR increased by 12% in the lower-dose group and 30% in the higher-dose group.
CONCLUSIONS


Both NaHCO 3  doses were well tolerated over 28 weeks with no significant difference in adverse events or hospitalization compared with placebo. The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR. The higher 0.8 meq/kg of lean body wt per day dose of NaHCO 3  may be a reasonable choice for future trials.",2020,The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR.,"['194 participants from ten clinical sites to receive', 'CKD', 'adults with eGFR 20-44 or 45-59 ml/min per 1.73 m 2  with urinary albumin/creatinine (ACR) ≥50 mg/g and serum bicarbonate 20-28 meq']","['ACR', 'NaHCO', 'placebo', 'sodium bicarbonate (NaHCO 3 ', 'higher-dose (HD-NaHCO 3 ; 0.8 meq/kg of lean body wt per day;  n =90) or lower-dose (LD-NaHCO 3 ; 0.5 meq/kg of lean body wt per day;  n =52', 'NaHCO 3  or matching placebo', 'Sodium Bicarbonate']","['serum bicarbonate', 'median (IQR', 'Mean urinary ammonium excretion', 'adverse events or hospitalization', 'proportions of adverse events and hospitalizations', 'ACR', 'urinary ammonium excretion', 'serum bicarbonate concentration', 'safety, tolerability, adherence, and pharmacodynamics', 'mean ACR', 'BP, weight, or serum potassium']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0439152', 'cui_str': 'milliequivalent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1300572', 'cui_str': 'mEq/kg'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}]",194.0,0.50479,The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR.,"[{'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Department of Internal Medicine, University of Utah Health and Renal Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; kalani.raphael@hsc.utah.edu.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California San Diego and Renal Section, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, George Washington University School of Medicine, Washington, DC.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Fried', 'Affiliation': 'Department of Medicine, University of Pittsburgh and Renal Section, Veterans Affairs Pittsburgh Health Care System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kendrick', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Larive', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Flessner', 'Affiliation': 'Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Mendley', 'Affiliation': 'Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Department of Medicine, Case Western Reserve Hospitals, Cleveland, Ohio.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Denver Nephrology, Denver, Colorado.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Renal Section, Veterans Affairs Washington, DC Health Care System, Washington, DC.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Middleton', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, Northshore University Health System, University of Chicago, Evanston, Illinois; and.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Health and Wellness Center, Baylor Scott & White Health, Dallas, Texas.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Internal Medicine, University of Utah Health and Renal Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019030287']
3420,31452148,Internalized HIV-Related Stigma and Breast Health Beliefs Among African-American Women Receiving Care for HIV in the USA.,"OBJECTIVES


African-American women suffer disproportionately from HIV, breast cancer, and other illnesses. Little is known about the relationship between internalized HIV-related stigma and health beliefs related to other illnesses, including breast cancer. Our study examined (1) the relationship between internalized HIV-related stigma and breast health beliefs over time and (2) the moderating effects of participating in a stigma reduction intervention and/or social support.
METHODS


Data from 239 African-American women receiving care for HIV in Chicago, IL, or Birmingham, AL, enrolled in the Unity randomized controlled trial, were used in this secondary analysis. Threat of breast cancer was measured in terms of perceived susceptibility, fear, and adverse consequences as well as an overall perceived threat of breast cancer. We used multivariate models with generalized estimating equations to examine the relationship between internalized HIV-related stigma and breast health beliefs across three time points (baseline, immediately post-workshop, and at 12-month follow-up) and to examine if the study arm (HIV stigma reduction vs. breast cancer education) or social support moderated the relationship.
RESULTS


Internalized HIV-related stigma was associated with greater overall perceived threat (p < 0.001), susceptibility (p = 0.03), fear (p < 0.001), and perceived adverse consequences (p < 0.001) of breast cancer. These associations remained consistent across study arms and across all levels of social support.
CONCLUSIONS


Future studies that examine co-morbid health conditions among African-American women living with HIV should consider the impact of HIV-related stigma on attitudes and beliefs related to co-morbid conditions.",2020,"RESULTS


Internalized HIV-related stigma was associated with greater overall perceived threat (p < 0.001), susceptibility (p = 0.03), fear (p < 0.001), and perceived adverse consequences (p < 0.001) of breast cancer.","['African-American women suffer disproportionately from HIV, breast cancer, and other illnesses', 'African-American women living with HIV', 'African-American Women Receiving Care for HIV in the USA', '239 African-American women receiving care for HIV in Chicago, IL, or Birmingham, AL']",['stigma reduction intervention and/or social support'],"['adverse consequences', 'Internalized HIV-Related Stigma and Breast Health Beliefs']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0037438'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}]",239.0,0.0342772,"RESULTS


Internalized HIV-related stigma was associated with greater overall perceived threat (p < 0.001), susceptibility (p = 0.03), fear (p < 0.001), and perceived adverse consequences (p < 0.001) of breast cancer.","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Fabian', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Yamilé', 'Initials': 'Y', 'LastName': 'Molina', 'Affiliation': 'Community Health Sciences Division, University of Illinois at Chicago, 1601 West Taylor Street, Chicago, IL, 60612, USA. Ymolin2@uic.edu.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Kemp', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Nevin', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katryna', 'Initials': 'K', 'LastName': 'McCoy', 'Affiliation': 'School of Nursing & Health Studies, University of Washington Bothell, Bothell, WA, USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Simoni', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Andrasik', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohn', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Micci', 'Affiliation': 'CORE Center/Division of Infectious Diseases, Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00632-6']
3421,31986239,"Evaluating body composition in infancy and childhood: A comparison between 4C, QMR, DXA, and ADP.","BACKGROUND


Accurate and precise methods to measure of body composition in infancy and childhood are needed.
OBJECTIVES


This study evaluated differences and precision of three methods when compared with the four-compartment (4C) model for estimating fat mass (FM).
METHODS


FM of children (age 14 days to 6 years of age, N = 346) was obtained using quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6 years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR). The 4C model was computed. Correlation, concordance, and Bland-Altman analyses were performed.
RESULTS


In infants, PeaPod had high individual FM accuracy, whereas DXA had high group FM accuracy compared with 4C. In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively). The instrument FM precision was best for QMR (10 g) followed by BodPod (34 g), PeaPod (38 g), and DXA (45 g).
CONCLUSIONS


In infants, PeaPod was the best method to estimate individual FM whereas DXA was best to estimate group FM. In children, DXA was best to estimate individual and group FM. QMR had the highest instrument precision.",2020,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","['infancy and childhood', 'FM of children (age 14\u2009days to 6\u2009years of age, N = 346']","['quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6\u2009years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR']","['individual FM accuracy', 'individual FM accuracies', 'FM accuracy']","[{'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0298047,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","[{'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Heard-Lipsmeyer', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hull', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Sims', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Cleves', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Andres', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}]",Pediatric obesity,['10.1111/ijpo.12617']
3422,31989151,Network Analysis Indicates That Avolition Is the Most Central Domain for the Successful Treatment of Negative Symptoms: Evidence From the Roluperidone Randomized Clinical Trial.,"A recent conceptual development in schizophrenia is to view its manifestations as interactive networks rather than individual symptoms. Negative symptoms, which are associated with poor functional outcome and reduced rates of recovery, represent a critical need in schizophrenia therapeutics. MIN101 (roluperidone), a compound in development, demonstrated efficacy in the treatment of negative symptoms in schizophrenia. However, it is unclear how the drug achieved its effect from a network perspective. The current study evaluated the efficacy of roluperidone from a network perspective. In this randomized clinical trial, participants with schizophrenia and moderate to severe negative symptoms were randomly assigned to roluperidone 32 mg (n = 78), 64 mg (n = 83), or placebo (N = 83). Macroscopic network properties were evaluated to determine whether roluperidone altered the overall density of the interconnections among symptoms. Microscopic properties were evaluated to examine which individual symptoms were most influential (ie, interconnected) on other symptoms in the network and are responsible for successful treatment effects. Participants receiving roluperidone did not differ from those randomized to placebo on macroscopic properties. However, microscopic properties (degree and closeness centrality) indicated that avolition was highly central in patients receiving placebo and that roluperidone reduced this level of centrality. These findings suggest that decoupling the influence of motivational processes from other negative symptom domains is essential for producing global improvements. The search for pathophysiological mechanisms and targeted treatment development should be focused on avolition, with the expectation of improvement in the entire constellation of negative symptoms if avolition is effectively treated.",2020,Macroscopic network properties were evaluated to determine whether roluperidone altered the overall density of the interconnections among symptoms.,['participants with schizophrenia and moderate to severe negative symptoms'],"['MIN101 (roluperidone', 'placebo', 'roluperidone']",[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.241904,Macroscopic network properties were evaluated to determine whether roluperidone altered the overall density of the interconnections among symptoms.,"[{'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Zamani Esfahlani', 'Affiliation': 'Department of Systems Science and Industrial Engineering & Center for Collective Dynamics of Complex Systems, Binghamton University, Binghamton, NY.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sayama', 'Affiliation': 'Department of Systems Science and Industrial Engineering & Center for Collective Dynamics of Complex Systems, Binghamton University, Binghamton, NY.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Reno School of Medicine, University of Nevada, Reno, NV.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Opler', 'Affiliation': 'MedAvante-ProPhase, New York, NY.'}, {'ForeName': 'Jay B', 'Initials': 'JB', 'LastName': 'Saoud', 'Affiliation': 'Minerva Neurosciences, Waltham, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Minerva Neurosciences, Waltham, MA.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Luthringer', 'Affiliation': 'Minerva Neurosciences, Waltham, MA.'}]",Schizophrenia bulletin,['10.1093/schbul/sbz141']
3423,31989155,"COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.","AIMS


Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 μg/mm2.
METHODS AND RESULTS


Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred.
CONCLUSION


Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths.
CLINICAL TRIAL REGISTRATION


The trial is registered with ClinicalTrials.gov (NCT02701543).",2020,Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01].,['414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4'],"['Drug-coated balloons (DCBs', 'high- vs. low-dose paclitaxel drug-coated balloons', 'endovascular treatment with either high- or low-dose DCB']","['Primary patency', 'efficacy and safety', 'Total occlusions', 'Overall death rate', 'primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1\u2009month, major amputations, and clinically driven target lesion revascularization through 12\u2009months']","[{'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",414.0,0.322573,Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01].,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steiner', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Liebigstraße 20, 04103 Leipzig, Germany.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Liebigstraße 20, 04103 Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Tepe', 'Affiliation': 'Department of Radiology, RoMed Clinic Rosenheim, Pettenkoferstraße 10, 83022 Rosenheim, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Thieme', 'Affiliation': 'Department of Angiology, Regiomed Gefäßzentrum Sonneberg, Neustadter Str. 61, 96515 Sonneberg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Maiwald', 'Affiliation': 'Department of Angiology, Kreiskrankenhaus Torgau, Christianistraße 1, 04860 Torgau, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'Gemeinschaftspraxis für Radiologie, Neuroradiologie & Zentrum für Minimal Invasive Therapie, Jüdisches Krankenhaus Berlin, Heinz-Galinski-Straße 1, 13347 Berlin, Germany.'}, {'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Euringer', 'Affiliation': 'Department of Radiology, Herz- und Gefäßzentrum Bad Bevensen, Römstedter Str. 25, 29549 Bad Bevensen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ulrich', 'Affiliation': 'Department of Angiology, Diakoniekrankenhaus Halle, Mühlweg 7, 06114 Halle (Saale), Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Brechtel', 'Affiliation': 'Gemeinschaftspraxis für Radiologie, Franziskus-Krankenhaus, Budapester Str. 15-19, 10787 Berlin, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Brucks', 'Affiliation': 'Angiologikum Hamburg, Wördemanns Weg 25-27, 22527 Hamburg, Germany.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Blessing', 'Affiliation': 'Department of Angiology, SRH Klinikum Karlsbad Langensteinbach, Guttmannstraße 1, 76307 Karlsbad, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'Department of Angiology, Kreiskrankenhaus Delitzsch GmbH, Kliniken Delitzsch und Eilenburg, Dübener Straße 3-9, 04509 Delitzsch, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Langhoff', 'Affiliation': 'Department of Angiology, Sankt Gertrauden Krankenhaus GmbH, Paretzer Str. 12, 10713 Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schellong', 'Affiliation': 'Department of Angiology, Medical Clinic 2, Municipal Hospital of Dresden, Heinrich-Cotta-Straße 12, 01324 Dresden, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Weiss', 'Affiliation': 'Division of Angiology, Department of Internal Medicine III, University Hospital Dresden, Fetscherstraße 74, 01307 Dresden, Germany.'}, {'ForeName': 'Dierk', 'Initials': 'D', 'LastName': 'Scheinert', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Liebigstraße 20, 04103 Leipzig, Germany.'}]",European heart journal,['10.1093/eurheartj/ehaa049']
3424,32036693,"Secretin effects on gastric functions, hormones and symptoms in functional dyspepsia and health: randomized crossover trial.","Abnormal gastric accommodation (GA) and gastric emptying contribute to pathophysiology in functional dyspepsia (FD). Secretin is a key regulator of GA in animal studies. Our aim was to study the effects of secretin on gastric motility, satiation, postprandial symptoms, and key hormones. We performed two double-blind, randomized, saline-controlled crossover trials in 10 healthy volunteers and 10 patients with FD by Rome IV criteria. We used measured GA (by validated SPECT method) after a  111 In radiolabeled Ensure 300-mL meal and quantified gastric emptying for 30 min by scintigraphy. Satiation was measured by volume to fullness (VTF) and maximum tolerated volume (MTV) on an Ensure nutrient drink test and postprandial symptoms 30 min post-MTV. Fasting and postprandial GLP-1, GIP, and HPP were measured. The ages and sex distribution of healthy controls and patients with FD were similar. Compared with placebo, secretin delayed gastric emptying at 30 min in both health [-11% (-16, -4),  P  = 0.004]; and FD [-8% (-9, 0),  P  = 0.03]. Satiation (VTF and MTV), GA, and plasma levels of GLP-1, GIP, and HPP did not differ between treatment arms in health or FD. On ANCOVA analysis (adjusting for age and sex), secretin did not consistently increase postprandial symptoms in health or FD. Secretin delayed gastric emptying in both health and FD without significantly altering GA, VTF, or MTV or selected hormones. Thus, secretin receptor activation may provide a novel therapeutic mechanism for patients with FD and rapid gastric emptying. NEW & NOTEWORTHY  The naturally occurring hormone secretin retards gastric emptying of solids without deleteriously affecting gastric accommodation, satiation, other upper gastrointestinal hormones, or postprandial symptoms. Given these findings, a subset of patients with rapid gastric emptying (e.g., the estimated 20% of patients with functional dyspepsia) could be candidates for treatments that stimulate a secretin receptor such as sacubitril, which inhibits neprilysin, an enzyme that degrades secretin.",2020,"Compared to placebo, secretin delayed gastric emptying at 30 minutes in both health [-11% (-16, -4); P=0.004] and FD [-8% (-9, 0); P=0.03].","['patients with FD and rapid gastric emptying', '10 healthy volunteers and 10 patients with FD by Rome IV criteria', 'DYSPEPSIA AND HEALTH', 'functional dyspepsia (FD']","['placebo', 'Secretin', 'secretin']","['postprandial symptoms in health or FD', 'Satiation (VTF and MTV), GA as well as plasma levels of GLP1, GIP and HPP', 'Abnormal gastric accommodation (GA) and gastric emptying', 'Fasting and postprandial GLP-1, GIP and HPP', 'secretin delayed gastric emptying', 'Secretin delayed gastric emptying', 'volume to fullness (VTF) and maximum tolerated volume (MTV', 'gastric motility, satiation, postprandial symptoms and key hormones']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232584', 'cui_str': 'Rapid gastric emptying (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036534', 'cui_str': 'Secretin'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0068293', 'cui_str': 'N-succinimidyl-3-(4-hydroxyphenyl)propionate'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0036534', 'cui_str': 'Secretin'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0232572', 'cui_str': 'Gastric motility, function (observable entity)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]",10.0,0.0959755,"Compared to placebo, secretin delayed gastric emptying at 30 minutes in both health [-11% (-16, -4); P=0.004] and FD [-8% (-9, 0); P=0.03].","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Brandler', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Laurence J', 'Initials': 'LJ', 'LastName': 'Miller', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Xiao Jing', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Busciglio', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Arndt', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}]",American journal of physiology. Gastrointestinal and liver physiology,['10.1152/ajpgi.00371.2019']
3425,31945626,Concurrent treatment with intratympanic dexamethasone improves facial nerve recovery in Ramsay Hunt syndrome.,"OBJECTIVE


To determine whether early intervention with intratympanic steroid injections, known as concurrent intratympanic steroid therapy (ITST), is an effective supplement to systemic steroid therapy for moderately-severe to severe Ramsay Hunt syndrome.
METHODS


Forty-six patients with Ramsay Hunt syndrome (House-Brackmann grade IV or higher) who received either concurrent ITST with standard systemic steroid therapy (ITST group, n = 12) or standard systemic therapy alone (control group, n = 34) with antivirals starting within 7 days of onset. Patients in the concurrent ITST group received the standard systemic dose of prednisolone (410 mg in total) and intratympanic dexamethasone (16.5 mg in total) over 10 consecutive days. Patients in the control group received systemic prednisolone at the standard dose or higher (average dose, 581 ± 25 mg).
RESULTS


The recovery rate was higher in the concurrent ITST group than in the control group (93% vs 47%, P = .013). The adjusted odds ratio was 22.2 (95% confidence interval 1.32-373.58, P = .031).
CONCLUSIONS


The recovery rate was higher after concurrent systemic and intratympanic steroid therapy than after standard systemic steroid therapy, regardless of whether the steroid used had lower or equivalent glucocorticoid potency. This finding suggests that concurrent intratympanic steroid therapy is a beneficial supplement in patients with Ramsay Hunt syndrome.",2020,"The recovery rate was higher after concurrent systemic and intratympanic steroid therapy than after standard systemic steroid therapy, regardless of whether the steroid used had lower or equivalent glucocorticoid potency.","['patients with Ramsay Hunt syndrome', 'Ramsay Hunt syndrome', 'moderately-severe to severe Ramsay Hunt syndrome', 'Forty-six patients with Ramsay Hunt syndrome (House-Brackmann grade IV or higher) who received either']","['intratympanic steroid therapy', 'intratympanic dexamethasone', 'intratympanic steroid injections, known as concurrent intratympanic steroid therapy (ITST', 'standard systemic dose of prednisolone', 'systemic prednisolone', 'concurrent ITST with standard systemic steroid therapy (ITST group, n\xa0=\xa012) or standard systemic therapy alone (control group, n\xa0=\xa034) with antivirals starting']","['facial nerve recovery', 'recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017409', 'cui_str': 'Geniculate Herpes Zoster'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0015462', 'cui_str': 'Nervus Facialis'}]",46.0,0.0770245,"The recovery rate was higher after concurrent systemic and intratympanic steroid therapy than after standard systemic steroid therapy, regardless of whether the steroid used had lower or equivalent glucocorticoid potency.","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Inagaki', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, Nagoya, Japan. Electronic address: ainagaki@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Minakata', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, Nagoya, Japan.'}, {'ForeName': 'Sachiyo', 'Initials': 'S', 'LastName': 'Katsumi', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, Nagoya, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Departments of Otolaryngology, Head and Neck Surgery, Nagoya City University, Graduate School of Medical Sciences and Medical School, Nagoya, Japan.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116678']
3426,31935382,"Comparison of a transdermal contraceptive patch with a newly sourced adhesive component versus EVRA patch: A double-blind, randomized, bioequivalence and adhesion study in healthy women.","OBJECTIVE


To evaluate the bioequivalence of norelgestromin and ethinyl estradiol (NGMN-EE) and adhesion of a transdermal contraceptive patch containing a newly sourced adhesive component (test) compared with the marketed (reference) patch.
STUDY DESIGN


In this randomized, double-blind, 2-way crossover study, healthy women received single 7-day application of both test and reference patches. Treatment phase included two treatment periods of 11 days each separated by a 21-day washout period starting from day of patch removal (day 8) of treatment period 1. Assessments included NGMN and EE pharmacokinetics (PK), adhesion using European Medicines Agency (EMA) 5-point scale, irritation potential and application-site reactions, and safety. Patches were bioequivalent if 90% CIs of ratios of means of test/reference for AUC 168h , AUC inf , and C ss  fell within 80-125%. Patch adhesion was comparable if ratios of mean cumulative adhesion percentage values of test/reference were ≥90.0%.
RESULTS


Seventy women were randomized; 57 completed both treatments with ≥80% adhesion (score 0-1). Bioequivalence of test and reference patches was demonstrated as 90% CI of ratio of geometric means for AUC 168h , AUC inf , and C ss  for NGMN and EE fell within 80-125%. Both patches had similar adhesion properties (geometric mean ratio was 100.3% [90% CI, 93.2-107.9]). Similar rates of mild-to-moderate itching (11% vs 10%) and erythema events (79% vs 74%) were reported for test and reference patches, respectively, on day 8.
CONCLUSIONS


The test patch with the newly sourced adhesive component is bioequivalent to the currently marketed NGMN-EE transdermal patch and has similar adhesion and irritation potential.
IMPLICATIONS STATEMENT


The norelgestromin and ethinyl estradiol transdermal patch containing a newly sourced adhesive component is bioequivalent to the currently marketed patch for both active moieties. Both patches had similar adhesion, irritation potential, and safety profiles.",2020,"Both patches had similar adhesion properties (geometric mean ratio was 100.3% [90% CI, 93.2-107.9]).","['Seventy women', 'healthy women']","['norelgestromin and ethinyl estradiol (NGMN-EE', 'transdermal contraceptive patch with a newly sourced adhesive component versus EVRA patch']","['NGMN and EE pharmacokinetics (PK), adhesion using European Medicines Agency (EMA) 5-point scale, irritation potential and application-site reactions, and safety', 'Similar rates of mild-to-moderate itching', 'adhesion properties', 'similar adhesion, irritation potential, and safety profiles', 'erythema events']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1120952', 'cui_str': 'norelgestromin'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C1456475', 'cui_str': 'Transdermal contraceptive'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1614506', 'cui_str': 'Ortho Evra'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0222045'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0151505', 'cui_str': 'Application site reaction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",70.0,0.155827,"Both patches had similar adhesion properties (geometric mean ratio was 100.3% [90% CI, 93.2-107.9]).","[{'ForeName': 'Dolly A', 'Initials': 'DA', 'LastName': 'Parasrampuria', 'Affiliation': 'Janssen Research & Development, 1400 McKean Road, Spring House, PA 19477, USA. Electronic address: dparasr@its.jnj.com.'}, {'ForeName': 'Subusola', 'Initials': 'S', 'LastName': 'Vaughan', 'Affiliation': 'Janssen Research & Development, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Ariyawansa', 'Affiliation': 'Janssen Research & Development, 1000 Route 202 South, Raritan, NJ 08869, USA.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Swinnen', 'Affiliation': 'Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Natarajan', 'Affiliation': 'Janssen Research & Development, 1000 Route 202 South, Raritan, NJ 08869, USA.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Rasschaert', 'Affiliation': 'Janssen Research & Development, Lange Bremstraat 70, 2170 Merksem, Belgium.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Massarella', 'Affiliation': 'Janssen Research & Development, 920 Route 202 South, Raritan, NJ 08869, USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fonseca', 'Affiliation': 'Janssen Research & Development, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA.'}]",Contraception,['10.1016/j.contraception.2019.12.012']
3427,31342226,Probiotics modulate the gut microbiota composition and immune responses in patients with atopic dermatitis: a pilot study.,"PURPOSE


Many studies have investigated the association between intestinal barrier impairment and the onset of atopic dermatitis (AD). The gut microbiota is essential to maintain physiological homeostasis and immune regulation of host. Therefore, the objectives were to determine the effects of probiotics on the clinical symptoms, immune responses, and gut microbiota in AD patients.
METHODS


109 patients were randomly divided into 4 groups, including placebo group, oligosaccharides group, Bifidobacterium bifidum CCFM16 group, and Lactobacillus plantarum CCFM8610 group. At the end of the experiment, serological indicators, SCORAD, and DLQI indices were assessed. V3-V4 region of the 16S ribosomal RNA gene was sequenced to evaluate changes in the gut microbiota. Linear discriminant analysis (LDA) effect size was used to uncover microbial biomarkers and PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) was used to predict gene family abundances based on 16S information.
RESULTS


The results demonstrated that CCFM8610 significantly decreased the SCORAD index, and increased the serum IL-10 levels. Supplement with CCFM8610 and CCFM16 significantly influenced the alpha diversity, increased the proportion of Bacteroidetes, and reduced the F/B ratio. CCFM8610 treatment downregulated the functional genes of gut microbiota involving Staphylococcus aureus infection and upregulated the steroid hormone biosynthesis.
CONCLUSION


The results indicated a positive correlation between decreased SCORAD index and CCFM8610 treatment, and that CCFM8610 regulated the immune responses in AD patients. CCFM8610 treatment influences the gut microbiota composition and functional changes. In conclusion, L. plantarum CCFM8610 exerts the strain-specific amelioration effects on patients with AD.
TRIAL REGISTRATION


ChiCTR1800015330 (Clinicaltrials.gov Identifier).",2020,"Supplement with CCFM8610 and CCFM16 significantly influenced the alpha diversity, increased the proportion of Bacteroidetes, and reduced the F/B ratio.","['patients with AD', 'AD patients', '109 patients', 'patients with atopic dermatitis']","['Probiotics', 'CCFM8610', 'CCFM8610 and CCFM16', 'placebo group, oligosaccharides group, Bifidobacterium bifidum CCFM16 group, and Lactobacillus plantarum CCFM8610 group', 'L. plantarum CCFM8610']","['SCORAD index', 'serological indicators, SCORAD, and DLQI indices', 'proportion of Bacteroidetes, and reduced the F/B ratio', 'alpha diversity', 'gut microbiota composition and functional changes', 'gut microbiota composition and immune responses', 'strain-specific amelioration effects', 'serum IL-10 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0995456', 'cui_str': 'Bacteroidetes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",109.0,0.0290228,"Supplement with CCFM8610 and CCFM16 significantly influenced the alpha diversity, increased the proportion of Bacteroidetes, and reduced the F/B ratio.","[{'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China. luwenwei@jiangnan.edu.cn.'}, {'ForeName': 'Jianxian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': ""The Tinghu People's Hospital, Yancheng, 224002, Jiangsu, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""The Tinghu People's Hospital, Yancheng, 224002, Jiangsu, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China. weichen@jiangnan.edu.cn.'}]",European journal of nutrition,['10.1007/s00394-019-02061-x']
3428,31342228,Long-term dietary adherence and changes in dietary intake in coronary patients after intervention with a Mediterranean diet or a low-fat diet: the CORDIOPREV randomized trial.,"PURPOSE


Adherence to a healthy dietary pattern positively influences clinical outcomes in cardiovascular prevention, but long-term adherence is difficult to maintain. We evaluated 5-year changes in dietary habits, adherence achieved, and its maintenance in a cohort of coronary patients from the CORDIOPREV study.
METHODS


1002 coronary patients were randomized to a Mediterranean diet (n = 502) or a low-fat diet (n = 500) and received individual-group-telephone visits and personalized dietary advice. A validated food-frequency questionnaire, a 14-point Mediterranean diet adherence screener, and a 9-point low-fat diet adherence score were used. Dietary adherence was categorized into Low, Medium, and High Adherence. Changes in nutrient intake, food consumption, and adherence were analyzed on a yearly basis. The maintenance of long-term dietary adherence was evaluated using data after the first year and fifth year.
RESULTS


From baseline to 5 years, significant increases were observed in overall dietary adherence (Mediterranean diet from 8.9 to 11.4; low-fat diet from 3.9 to 7.1) and in the percentage of patients considered High Adherence (Mediterranean diet from 41 to 89%; low-fat diet from 4 to 67%). When we evaluated the maintenance of adherence, patients considered Low and Medium Adherence at 1 year increased their adherence at the 5 years with both diets and patients considered High Adherence maintained their adherence with a Mediterranean diet, but decreased their adherence with a low-fat diet.
CONCLUSIONS


A comprehensive dietary intervention results in an overall long-term improvement and maintenance of adherence to the Mediterranean and low-fat diets. In our population, the Mediterranean diet group achieved a high level of adherence in the short term which was maintained in the long term.",2020,A comprehensive dietary intervention results in an overall long-term improvement and maintenance of adherence to the Mediterranean and low-fat diets.,"['coronary patients after intervention with a Mediterranean diet or a low-fat diet', '1002 coronary patients']","['Mediterranean diet', 'Mediterranean diet (n\u2009=\u2009502) or a low-fat diet (n\u2009=\u2009500) and received individual-group-telephone visits and personalized dietary advice']","['level of adherence', 'maintenance of long-term dietary adherence', 'nutrient intake, food consumption, and adherence', 'dietary intake', 'overall dietary adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1002.0,0.0174968,A comprehensive dietary intervention results in an overall long-term improvement and maintenance of adherence to the Mediterranean and low-fat diets.,"[{'ForeName': 'Gracia Maria', 'Initials': 'GM', 'LastName': 'Quintana-Navarro', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Alcala-Diaz', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Moreno', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Perez-Corral', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Leon-Acuña', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Jose David', 'Initials': 'JD', 'LastName': 'Torres-Peña', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Oriol Alberto', 'Initials': 'OA', 'LastName': 'Rangel-Zuñiga', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Antonio Pablo', 'Initials': 'AP', 'LastName': 'Arenas de Larriva', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Corina', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Camargo', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Elena Maria', 'Initials': 'EM', 'LastName': 'Yubero-Serrano', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodriguez-Cantalejo', 'Affiliation': 'Biochemical Laboratory, Reina Sofia University Hospital, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Raul Miguel', 'Initials': 'RM', 'LastName': 'Luque', 'Affiliation': 'Department of Cell Biology, Physiology, and Immunology, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Ordovas', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Delgado-Lista', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain. delgadolista@gmail.com.'}]",European journal of nutrition,['10.1007/s00394-019-02059-5']
3429,31898874,"History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial.","OBJECTIVE


To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]).
METHODS


This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes.
RESULTS


Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group.
CONCLUSIONS


Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.",2020,"In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group.
","['Diabetes', '5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education']",['intensive lifestyle intervention (ILI'],"['adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes', 'cardiovascular disease (CVD', 'weight loss and physical fitness, or hypoglycemic events', 'Event rates', 'nonfatal MI', 'low-density lipoprotein cholesterol levels']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",5145.0,0.198386,"In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bantle', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Brancati', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Cheskin', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Egan', 'Affiliation': 'The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Ghazarian', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Barone Gibbs', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Glasser', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'W Gregg', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hesson', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Van S', 'Initials': 'VS', 'LastName': 'Hubbard', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Abbas E', 'Initials': 'AE', 'LastName': 'Kitabchi', 'Affiliation': 'The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Dalane', 'Initials': 'D', 'LastName': 'Kitzman', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lipkin', 'Affiliation': 'US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Michaels', 'Affiliation': 'Southwestern American Indian Center, Shiprock, New Mexico, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Nyenwe', 'Affiliation': 'The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ""St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ""St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22676']
3430,31738283,"Effect of Dextrose Prolotherapy on Pain Intensity, Disability, and Plantar Fascia Thickness in Unilateral Plantar Fasciitis: A Randomized, Controlled, Double-Blind Study.","OBJECTIVE


The aim of the study was to evaluate the efficacy of dextrose prolotherapy in the treatment of chronic resistant plantar fasciitis through comparison with a control group.
DESIGN


In this double-blind, randomized, controlled study, the patients were divided into two groups. The prolotherapy group (n = 30) was administered 5 ml of 30% dextrose, 4 ml of saline, and 1 ml of 2% lidocaine mixture (15% dextrose solution) and the control group was given 9 ml of saline and 1 ml of 2% lidocaine mixture twice at a 3-wk interval. During the 15-wk follow-up period, pain intensity was measured using the visual analog scale during activity and at rest. The foot function index was used to measure pain and disability. The plantar fascia thickness was measured by ultrasonography. The measurements were undertaken before treatment and at posttreatment weeks 7 and 15.
RESULTS


Improvements in visual analog scale during activity, at rest, foot function index (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared with the control group (P < 0.001).
CONCLUSIONS


Dextrose prolotherapy has efficacy up to 15 wks and can be used as an alternative method in the treatment of chronic resistant plantar fasciitis.",2020,"RESULTS


Improvements in VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared to the control group (p>0.001).
","['chronic resistant plantar fasciitis (PF', 'Unilateral Plantar Fasciitis']","['Dextrose prolotherapy', 'Dextrose Prolotherapy', '5 cc 30% dextrose, 4 cc saline, 1cc 2% lidocaine mixture (15% dextrose solution) and the control group was given 9 cc saline and 1 cc 2% lidocaine mixture', 'prolotherapy', 'dextrose prolotherapy']","['visual analog scale during activity (VAS-A) and at rest (VAS-R', 'pain and disability', 'VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness', 'plantar fascia thickness', 'pain intensity', 'foot function index (FFI', 'Pain Intensity, Disability and Plantar Fascia Thickness']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0500223', 'cui_str': 'Proliferation Therapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0078085', 'cui_str': 'VAS-A'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}]",,0.0651174,"RESULTS


Improvements in VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared to the control group (p>0.001).
","[{'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Mansiz-Kaplan', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Nacir', 'Affiliation': ''}, {'ForeName': 'Secil', 'Initials': 'S', 'LastName': 'Pervane-Vural', 'Affiliation': ''}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Duyur-Cakit', 'Affiliation': ''}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Genc', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001330']
3431,32139485,"Efficacy and economic evaluation of delivery of care with tele-continuous EEG in critically ill patients: a multicentre, randomised controlled trial (Tele-cRCT) study protocol.","INTRODUCTION


Some critically ill patients are confirmed by continuous electroencephalography (cEEG) monitoring that non-convulsive seizure (NCS) and/or non-convulsive status epilepticus (NCSE) are causes of their depressed level of consciousness. Shortage of epilepsy specialists, especially in developing countries, is a major limiting factor in implementing cEEG in general practice. Delivery of care with tele-continous EEG (tele-cEEG) may be a potential solution as this allows specialists from a central facility to remotely assist local neurologists from distant areas in interpreting EEG findings and suggest proper treatment. No tele-cEEG programme has been implemented to help improve quality of care. Therefore, this study is conducted to assess the efficacy and cost utility of implementing tele-cEEG in critical care.
METHODS AND ANALYSIS


The Tele-cRCT study is a 3-year prospective, randomised, controlled, parallel, multicentre, superiority trial comparing delivery of care through 'Tele-cEEG' intervention with 'Tele-routine EEG (Tele-rEEG)' in patients with clinical suspicion of NCS/NCSE. A group of EEG specialists and a tele-EEG system were set up to remotely interpret EEG findings in six regional government hospitals across Thailand. The primary outcomes are functional neurological outcome (modified Rankin Scale, mRS), mortality rate and incidence of seizures. The secondary outcomes are cost utility, length of stay, emergency visit/readmission, impact on changing medical decisions and health professionals' perceptions about tele-cEEG implementation. Functional outcome (mRS) will be assessed at 3 and 7 days after recruitment, and again at time of hospital discharge, and at 90 days, 6 months, 9 months and 1 year. Costs and health-related quality of life will be assessed using the Thai version of the EuroQol-five dimensions-five levels (EQ-5D-5L) at hospital discharge, and at 90 days, 6 months, 9 months and 1 year.
ETHICS AND DISSEMINATION


This study has been approved by the ethics committees of the Faculty of Medicine, Chulalongkorn University, and of Ramathibodi Hospital, Mahidol University, and registered on Thai Clinical Trials Registry. The results will be disseminated in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


TCTR20181022002; preresults.",2020,A group of EEG specialists and a tele-EEG system were set up to remotely interpret EEG findings in six regional government hospitals across Thailand.,"['critically ill patients', 'patients with clinical suspicion of NCS/NCSE']","['delivery of care with tele-continuous EEG', 'care with tele-continous EEG (tele-cEEG', ""care through 'Tele-cEEG' intervention with 'Tele-routine EEG (Tele-rEEG""]","['Functional outcome (mRS', 'functional neurological outcome (modified Rankin Scale, mRS), mortality rate and incidence of seizures', 'quality of care', ""cost utility, length of stay, emergency visit/readmission, impact on changing medical decisions and health professionals' perceptions about tele-cEEG implementation"", 'Costs and health-related quality of life']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0938006,A group of EEG specialists and a tele-EEG system were set up to remotely interpret EEG findings in six regional government hospitals across Thailand.,"[{'ForeName': 'Chusak', 'Initials': 'C', 'LastName': 'Limotai', 'Affiliation': 'Division of Neurology, Department of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Atiporn', 'Initials': 'A', 'LastName': 'Ingsathit', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand atiporn.ing@mahidol.ac.th.'}, {'ForeName': 'Kunlawat', 'Initials': 'K', 'LastName': 'Thadanipon', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Oraluck', 'Initials': 'O', 'LastName': 'Pattanaprateep', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Anuchate', 'Initials': 'A', 'LastName': 'Pattanateepapon', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kammant', 'Initials': 'K', 'LastName': 'Phanthumchinda', 'Affiliation': 'Division of Neurology, Department of Medicine, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Nijasri C', 'Initials': 'NC', 'LastName': 'Suwanwela', 'Affiliation': 'Division of Neurology, Department of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Iyavut', 'Initials': 'I', 'LastName': 'Thaipisuttikul', 'Affiliation': 'Division of Neurology, Department of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Boonyapisit', 'Affiliation': 'Division of Neurology, Department of Medicine, Mahidol University Faculty of Medicine Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Thakkinstian', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand.'}]",BMJ open,['10.1136/bmjopen-2019-033195']
3432,32139486,Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial.,"INTRODUCTION


Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive-behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.
METHODS AND ANALYSIS


This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.
ETHICS AND DISSEMINATION


This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.
TRIAL REGISTRATION NUMBER


ChiCTR1900023473; Pre-results.",2020,Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group.,"['Eligible patients', '152 participants']","['acupuncture', 'Acupuncture', 'treatment group (acupuncture) and the control group (placebo acupuncture', 'placebo acupuncture', 'normal sleep duration group and insomnia with short sleep duration group']","['actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale', 'efficacy and safety', 'Pittsburgh Sleep Quality Index and the Insomnia Severity Index', 'objective total sleep time: insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",152.0,0.14388,Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group.,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wen-Jia', 'Initials': 'WJ', 'LastName': 'Yang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xin-Tong', 'Initials': 'XT', 'LastName': 'Yu', 'Affiliation': 'Laboratory Center of Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jin-Jin', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wen-Lin', 'Initials': 'WL', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yi-Xin', 'Initials': 'YX', 'LastName': 'Zheng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China icyf1968@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-033731']
3433,32100933,"A randomized double-blind clinical trial to evaluate the efficacy of chlorhexidine, antioxidant, and hyaluronic acid mouthwashes in the management of biofilm-induced gingivitis.","OBJECTIVES


To investigate the antiplaque and antigingivitis efficacy in addition to evaluating side effects and subjects' perceptions of three commercially available mouthwashes.
METHODS


This study was a double-blind, parallel, and short-term trial. A total of 75 dental students with biofilm-induced gingivitis were included in the final analysis of the current study. Clinical parameters (plaque index and bleeding on probing) and the staining effect were measured at baseline and after 7 days. In addition, a VAS-based assessment questionnaire was completed by the participants.
RESULTS


All interventions significantly reduced plaque scores, but chlorhexidine (CHX) had a significantly higher effect than the hyaluronic acid (HA) and antioxidant mouthwashes. However, all mouthwashes significantly reduced the total bleeding scores to <10% in 53% of the patients, compared to the baseline record. Additionally, teeth underwent shade changes in association with all interventions by the end of the study. Analysis of feedback about the mouthwashes showed that the participants seemed to prefer the HA mouthwash over the other mouthwashes.
CONCLUSIONS


CHX remains the most effective antiplaque mouthwash although HA and antioxidants are as effective as CHX in reducing bleeding. In addition, based on its better acceptance by the participants, HA is potentially a good alternative to CHX.",2020,"However, all mouthwashes significantly reduced the total bleeding scores to <10% in 53% of the patients, compared to the baseline record.","['biofilm-induced gingivitis', '75 dental students with biofilm-induced gingivitis']","['hyaluronic acid (HA', 'chlorhexidine, antioxidant, and hyaluronic acid mouthwashes', 'chlorhexidine (CHX']","['Clinical parameters (plaque index and bleeding on probing) and the staining effect', 'plaque scores', 'total bleeding scores']","[{'cui': 'C0081786', 'cui_str': 'Biofilms'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0038493', 'cui_str': 'Students, Dental'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",75.0,0.267296,"However, all mouthwashes significantly reduced the total bleeding scores to <10% in 53% of the patients, compared to the baseline record.","[{'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Abdulkareem', 'Affiliation': 'College of Dentistry, University of Baghdad, Baghdad, Iraq.'}, {'ForeName': 'Zaid A', 'Initials': 'ZA', 'LastName': 'Al Marah', 'Affiliation': 'Faculty of Dentistry, Dijlah University College, Baghdad, Iraq.'}, {'ForeName': 'Hayder R', 'Initials': 'HR', 'LastName': 'Abdulbaqi', 'Affiliation': 'College of Dentistry, University of Baghdad, Baghdad, Iraq.'}, {'ForeName': 'Ali J', 'Initials': 'AJ', 'LastName': 'Alshaeli', 'Affiliation': 'College of Dentistry, University of Baghdad, Baghdad, Iraq.'}, {'ForeName': 'Mike R', 'Initials': 'MR', 'LastName': 'Milward', 'Affiliation': 'College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]",International journal of dental hygiene,['10.1111/idh.12432']
3434,32143737,Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC).,"BACKGROUND


Complications of preterm birth cause more than 1 million deaths each year, mostly within the first day after birth (47%) and before full post-natal stabilisation. Kangaroo mother care (KMC), provided as continuous skin-to-skin contact for 18 h per day to fully stabilised neonates ≤ 2000 g, reduces mortality by 36-51% at discharge or term-corrected age compared with incubator care. The mortality effect of starting continuous KMC before stabilisation is a priority evidence gap, which we aim to investigate in the eKMC trial, with a secondary aim of understanding mechanisms, particularly for infection prevention.
METHODS


We will conduct a single-site, non-blinded, individually randomised, controlled trial comparing two parallel groups to either early (within 24 h of admission) continuous KMC or standard care on incubator or radiant heater with KMC when clinically stable at > 24 h of admission. Eligible neonates (n = 392) are hospitalised singletons or twins < 2000 g and 1-24 h old at screening who are mild to moderately unstable as per a trial definition using cardio-respiratory parameters. Randomisation is stratified by weight category (< 1200 g; ≥ 1200 g) and in random permuted blocks of varying sizes with allocation of twins to the same arm. Participants are followed up to 28 ± 5 days of age with regular inpatient assessments plus criteria-led review in the event of clinical deterioration. The primary outcome is all-cause neonatal mortality by age 28 days. Secondary outcomes include the time to death, cardio-respiratory stability, hypothermia, exclusive breastfeeding at discharge, weight gain at age 28 days, clinically suspected infection (age 3 to 28 days), intestinal carriage of extended-spectrum beta-lactamase producing (ESBL) Klebsiella pneumoniae (age 28 days), and duration of the hospital stay. Intention-to-treat analysis will be applied for all outcomes, adjusting for twin gestation.
DISCUSSION


This is one of the first clinical trials to examine the KMC mortality effect in a pre-stabilised preterm population. Our findings will contribute to the global evidence base in addition to providing insights into the infection prevention mechanisms and safety of using this established intervention for the most vulnerable neonatal population.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03555981. Submitted 8 May 2018 and registered 14 June 2018. Prospectively registered.",2020,This is one of the first clinical trials to examine the KMC mortality effect in a pre-stabilised preterm population.,"['pre-stabilised preterm neonates in The Gambia (eKMC', '2000\u2009g and 1-24\u2009h old at screening who are mild to moderately unstable as per a trial definition using cardio-respiratory parameters', 'Eligible neonates (n\xa0=\u2009392) are hospitalised singletons or twins ', 'Participants are followed up to 28 ± 5 days of age with regular inpatient assessments plus criteria-led review in the event of clinical deterioration']","['early kangaroo mother care', 'Kangaroo mother care (KMC', 'KMC or standard care on incubator or radiant heater with KMC']","['mortality', 'mortality effect', 'cause neonatal mortality', 'KMC mortality effect', 'time to death, cardio-respiratory stability, hypothermia, exclusive breastfeeding at discharge, weight gain at age\xa028 days, clinically suspected infection (age\xa03 to 28 days), intestinal carriage of extended-spectrum beta-lactamase producing (ESBL) Klebsiella pneumoniae (age\xa028 days), and duration of the hospital stay']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0016993', 'cui_str': 'Republic of the Gambia'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0348052', 'cui_str': 'Radiant heater (physical object)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1444098', 'cui_str': 'Extended spectrum beta-lactamase producing Klebsiella pneumoniae'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.234544,This is one of the first clinical trials to examine the KMC mortality effect in a pre-stabilised preterm population.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brotherton', 'Affiliation': 'Faculty of Epidemiology and Population Health, and MARCH Centre, London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street, London, UK. helen.brotherton@lshtm.ac.uk.'}, {'ForeName': 'Abdou', 'Initials': 'A', 'LastName': 'Gai', 'Affiliation': 'MRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, The Gambia.'}, {'ForeName': 'Cally J', 'Initials': 'CJ', 'LastName': 'Tann', 'Affiliation': 'Faculty of Epidemiology and Population Health, and MARCH Centre, London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street, London, UK.'}, {'ForeName': 'Ahmadou Lamin', 'Initials': 'AL', 'LastName': 'Samateh', 'Affiliation': 'Ministry of Health and Social Welfare, Gambia Government, Banjul, The Gambia.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Seale', 'Affiliation': 'Faculty of Epidemiology and Population Health, and MARCH Centre, London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street, London, UK.'}, {'ForeName': 'Syed M A', 'Initials': 'SMA', 'LastName': 'Zaman', 'Affiliation': 'Education Department, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'Faculty of Epidemiology and Population Health, and MARCH Centre, London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roca', 'Affiliation': 'MRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, The Gambia.'}, {'ForeName': 'Joy E', 'Initials': 'JE', 'LastName': 'Lawn', 'Affiliation': 'Faculty of Epidemiology and Population Health, and MARCH Centre, London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street, London, UK.'}]",Trials,['10.1186/s13063-020-4149-y']
3435,27765757,"Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial.","BACKGROUND


We report the first randomized, Phase II trial of ramucirumab, an anti-vascular endothelial growth factor receptor-2 monoclonal antibody, as front-line therapy in patients with advanced adenocarcinoma of the esophagus or gastric/gastroesophageal junction (GEJ).
PATIENTS AND METHODS


Patients from the USA with advanced esophageal, gastric, or GEJ adenocarcinoma randomly received (1:1) mFOLFOX6 plus ramucirumab (8 mg/kg) or mFOLFOX6 plus placebo every 2 weeks. The primary end point was progression-free survival (PFS) with 80% power to detect a hazard ratio (HR) of 0.71 (one-sided α = 0.15). Secondary end points included evaluation of response and overall survival (OS); an exploratory ramucirumab exposure-response analysis was undertaken.
RESULTS


Of 168 randomized patients, 52% of tumors were located in the stomach/GEJ and 48% in the esophagus. The trial did not meet the primary end point of PFS [6.4 versus 6.7 months, HR 0.98 (95% confidence interval 0.69-1.37)] or the secondary end point of OS (11.7 versus 11.5 months) in the intent-to-treat (ITT) population. Objective response rates (45.2% versus 46.4%) were similar between arms. Most Grade ≥3 toxicities did not differ significantly between arms, yet premature discontinuation of FOLFOX and ramucirumab (for reasons other than progressive disease) was more common among ramucirumab- versus placebo-treated patients. In an exploratory analysis that censored for premature discontinuation, the HR for PFS favored the ramucirumab arm (HR 0.76), particularly in patients with gastric/GEJ cancer. An exploratory exposure-response analysis indicated that patients with higher ramucirumab exposure had longer OS.
CONCLUSION


The addition of ramucirumab to front-line mFOLFOX6 did not improve PFS in the ITT population.
CLINICALTRIALSGOV IDENTIFIER


NCT01246960.",2016,"Most Grade ≥3 toxicities did not differ significantly between arms, yet premature discontinuation of FOLFOX and ramucirumab (for reasons other than progressive disease) was more common among ramucirumab- versus placebo-treated patients.","['Patients from the USA with advanced esophageal, gastric, or GEJ adenocarcinoma randomly received (1:1', 'patients with higher ramucirumab exposure had longer OS', 'patients with advanced adenocarcinoma of the esophagus or gastric/gastroesophageal junction (GEJ', 'patients with gastric/GEJ cancer', 'advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma']","['mFOLFOX6 plus ramucirumab', 'placebo', 'mFOLFOX6 plus placebo', 'Ramucirumab combined with FOLFOX', 'ramucirumab']","['Grade ≥3 toxicities', 'Objective response rates', 'PFS', 'evaluation of response and overall survival (OS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",168.0,0.50945,"Most Grade ≥3 toxicities did not differ significantly between arms, yet premature discontinuation of FOLFOX and ramucirumab (for reasons other than progressive disease) was more common among ramucirumab- versus placebo-treated patients.","[{'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Yoon', 'Affiliation': 'Medical Oncology, Mayo Clinic, Rochester, MN yoon.harry@mayo.edu.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'GI Cancer Research Program, Sarah Cannon Research Institute, Tennessee Oncology, Nashville.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Braiteh', 'Affiliation': 'Medical Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Firdaus', 'Affiliation': 'Medical Oncology, Sarah Cannon Research Institute/Oncology Hematology Care, Inc., Cincinnati.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Department of Oncology, Barbara Ann Karmanos Cancer Institute/Wayne State University, Detroit.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Cohn', 'Affiliation': 'Medical Oncology, Rocky Mountain Cancer Centers/US Oncology, Denver.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lewis', 'Affiliation': 'Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Department of Hematology, Oncology and Transplantation, Metro-Minnesota Community Clinical Oncology Program, St. Louis Park.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Arrowsmith', 'Affiliation': 'Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Chattanooga.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schwartz', 'Affiliation': 'Oncology, Eli Lilly and Company, Bridgewater.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Oncology, Eli Lilly and Company, Bridgewater.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'Oncology, Eli Lilly and Company, Bridgewater.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Oncology, Eli Lilly and Company, Bridgewater.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Oncology, Eli Lilly and Company, Bridgewater.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Medical Oncology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'Division of Hematology Oncology, David Geffen School of Medicine at UCLA, Los Angeles, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw423']
3436,31725787,Changes over time in creatinine clearance and comparison of emergent adverse events for HIV-positive adults receiving standard doses (300 mg/day) of lamivudine-containing antiretroviral therapy with baseline creatinine clearance of 30-49 vs ≥50 mL/min.,"A retrospective analysis of the randomized controlled DART (Development of AntiRetroviral Therapy in Africa; ISRCTN13968779) trial in HIV-1-positive adults initiating antiretroviral therapy with co-formulated zidovudine/lamivudine plus either tenofovir, abacavir, or nevirapine was conducted to evaluate the safety of initiating standard lamivudine dosing in patients with impaired creatinine clearance (CLcr). Safety data collected through 96 weeks were analyzed after stratification by baseline CLcr (estimated using Cockcroft-Gault) of 30-49 mL/min (n = 168) versus ≥50 mL/min (n = 3,132) and treatment regimen. The Grade 3-4 adverse events (AEs) and serious AEs (for hematological, hepatic and gastrointestinal events), maximal toxicities for liver enzymes, serum creatinine and bilirubin and maximum treatment-emergent hematology toxicities were comparable for groups with baseline CLcr 30-49 versus CLcr≥50 mL/min. No new risks or trends were identified from this dataset. Substantial and similar increases in the mean creatinine clearance (>25 mL/min) were observed from baseline though Week 96 among participants who entered the trial with CLcr 30-49 mL/min, while no increase or smaller median changes in creatinine clearance (<7 mL/min) were observed for participants who entered the trial with CLcr ≥50 mL/min. Substantial increases (> 150 cells/ mm3) in mean CD4+ cells counts from baseline to Week 96 were also observed for participants who entered the trial with CLcr 30-49 mL/min and those with baseline CLcr ≥50 mL/min. Though these results are descriptive, they suggest that HIV-positive patients with CLcr of 30-49 mL/min would have similar AE risks in comparison to patients with CLcr ≥50 mL/min when initiating antiretroviral therapy delivering doses of 300 mg of lamivudine daily through 96 weeks of treatment. Overall improvements in CLcr were observed for patients with baseline CLcr 30-49 mL/min.",2019,"Substantial and similar increases in the mean creatinine clearance (>25 mL/min) were observed from baseline though Week 96 among participants who entered the trial with CLcr 30-49 mL/min, while no increase or smaller median changes in creatinine clearance (<7 mL/min) were observed for participants who entered the trial with CLcr ≥50 mL/min.","['HIV-1-positive adults initiating antiretroviral therapy with co-formulated', 'patients with impaired creatinine clearance (CLcr']","['lamivudine', 'lamivudine-containing antiretroviral therapy', 'zidovudine/lamivudine plus either tenofovir, abacavir, or nevirapine']","['mean creatinine clearance', 'Grade 3-4 adverse events (AEs) and serious AEs (for hematological, hepatic and gastrointestinal events), maximal toxicities for liver enzymes, serum creatinine and bilirubin and maximum treatment-emergent hematology toxicities', 'CLcr', 'mean CD4+ cells counts', 'creatinine clearance']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",,0.199508,"Substantial and similar increases in the mean creatinine clearance (>25 mL/min) were observed from baseline though Week 96 among participants who entered the trial with CLcr 30-49 mL/min, while no increase or smaller median changes in creatinine clearance (<7 mL/min) were observed for participants who entered the trial with CLcr ≥50 mL/min.","[{'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Ross', 'Affiliation': 'Medical Affairs, ViiV Healthcare, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College, London, United Kingdom.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Statistics, PAREXEL International, Durham, NC, United States of America.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'Physicians Group, ViiV Healthcare, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College, London, United Kingdom.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Double', 'Affiliation': 'Safety and Medical Governance, GlaxoSmithKline, Stockley Park, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gilks', 'Affiliation': 'School of Population Health, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Cynthia C', 'Initials': 'CC', 'LastName': 'McCoig', 'Affiliation': 'Physicians Group, ViiV Healthcare, Tres Cantos, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Munderi', 'Affiliation': 'HIV Care Research Programme, MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Musoro', 'Affiliation': 'Department of Medicine, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Cissy M', 'Initials': 'CM', 'LastName': 'Kityo', 'Affiliation': 'HIV Clinical Trials Unit, Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Grosskurth', 'Affiliation': 'HIV Care Research Programme, MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'Department of Medicine, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Mugyenyi', 'Affiliation': 'HIV Clinical Trials Unit, Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cutrell', 'Affiliation': 'Healthcare Statistics, ViiV Healthcare, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Perger', 'Affiliation': 'Safety and Pharmacovigilance, ViiV Healthcare, London, United Kingdom.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Shaefer', 'Affiliation': 'Medical Affairs, ViiV Healthcare, Research Triangle Park, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0225199']
3437,30822800,"Multimodal Pain Management for Cesarean Delivery: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial.","OBJECTIVE


Our objective was to evaluate the efficacy of perioperative multimodal pain management in reducing opioid use after elective cesarean delivery (CD).
STUDY DESIGN


A single-center, double-blinded, placebo-controlled randomized trial of women undergoing elective CD. Participants were allocated 1:1 to receive the multimodal protocol or matching placebos. The multimodal protocol consisted of a preoperative dose of intravenous acetaminophen, preincision injection of subcutaneous bupivacaine, and intraoperative injection of intramuscular ketorolac. Primary outcome was total opioid intake at 48 hours postoperatively. Secondary outcomes were pain scores, time to first opioid intake, neonatal outcomes, and total outpatient opioid intake on postoperative day (POD) 7. Data were analyzed using parametric and nonparametric tests and quantile regression as appropriate.
RESULTS


A total of 242 women were screened with 120 randomized, 60 to the multimodal group and 60 to control group. There was no significant difference in the primary outcome of opioid use nor in the secondary outcomes. Smokers and patients with a history of drug use had higher median postoperative opiate use and earlier administration. On POD 7, only 40% of prescribed opioids had been used, and there was no difference between the groups.
CONCLUSION


This perioperative multimodal pain regimen did not reduce opioid use in 48 hours after CD. Patients who smoke or with a history of drug use required more opioids in the postoperative period. Providers significantly overprescribed opioids after CD.",2019,There was no significant difference in the primary outcome of opioid use nor in the secondary outcomes.,"['Smokers and patients with a history of drug use had higher median postoperative opiate use and earlier administration', 'Patients who smoke or with a history of drug use required more opioids in the postoperative period', 'A total of 242 women were screened with 120 randomized, 60 to the multimodal group and 60 to control group', 'women undergoing elective CD', 'Cesarean Delivery']","['placebo', 'Placebo', 'Multimodal Pain Management', 'multimodal protocol or matching placebos', 'perioperative multimodal pain management', 'acetaminophen, preincision injection of subcutaneous bupivacaine, and intraoperative injection of intramuscular ketorolac']","['pain scores, time to first opioid intake, neonatal outcomes, and total outpatient opioid intake on postoperative day (POD) 7', 'total opioid intake']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",242.0,0.463879,There was no significant difference in the primary outcome of opioid use nor in the secondary outcomes.,"[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hadley', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Monsivais', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pacheco', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Rovnat', 'Initials': 'R', 'LastName': 'Babazade', 'Affiliation': 'Department of Anesthesia, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Chiossi', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Ramirez', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Ellis', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesia, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Costantine', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}]",American journal of perinatology,['10.1055/s-0039-1681096']
3438,32189314,[Bioavailability of natural versus synthetic B vitamins and their effects on metabolic processes].,"BACKGROUND


Owing to the widespread use of vitamin supplements to prevent and compensate for deficiencies, the equivalence of natural versus synthetic vitamins with respect to their bioavailability and metabolic influence is discussed controversially.
METHOD


Thirty healthy female (n=22) and male participants (n=8) were investigated in a randomized, double-blind, cross-over study over a supplementation period of 6 weeks for each condition. The participants received a daily dose of a complex of the 8 natural B vitamins (group N), determined by the natural composition of quinoa seedlings, resp. synthetic B vitamins (group S), both corresponding to about 2.5 times the Recommended Dietary Allowance (RDA) of the national nutrition board. The primary criterion under investigation was changes in the blood levels of the individual B vitamins. Secondary criteria were the influence of both B complexes on homocysteine, antioxidant status, polyphenols, peroxide loading and peroxidase activity.
RESULTS


Compared to baseline values, serum levels of all B vitamins measured increased: Vitamins B1 (N +23%; S +27%), B2 (N +14%; S +13%), B6 (N +101%; S +101%), B9 (N +86%; S +153%) and B12 (N +16%) were elevated at the end of the first supplementation period (p < 0.05), while serum levels of vitamins B1, B9 and B12 remained elevated compared to baseline even after the 2-week washout phase. During the second supplementation period, the vitamin concentrations in group N, with the exception of vitamin B1, could be increased once again (p < 0.05). In contrast, in group S only for vitamins B2 and B12 substantial increases (p < 0.05) were found. The influence of B vitamins on metabolic parameters such as homocysteine and polyphenols, which were markedly reduced, was also clearly measurable; however, total antioxidant capacity and peroxidase activity increased. The peroxide concentration remained almost unchanged in both groups.
CONCLUSION


This clinical pilot study showed comparable bioavailability for both natural and synthetic B vitamins, with a 2.5-fold concentration of the RDA. Both vitamin B preparations showed a clear influence on metabolic parameters, whereas that of the natural B vitamins tended to have a slightly stronger effect than the synthetic analogues.",2020,"In contrast, in group S only for vitamins B2 and B12 substantial increases (p < 0.05) were found.",['Thirty healthy female (n=22) and male participants (n=8'],"['natural versus synthetic B vitamins', 'vitamin B preparations', 'B vitamins', 'complex of the 8 natural B vitamins', 'synthetic B vitamins', 'vitamin supplements']","['total antioxidant capacity and peroxidase activity', 'metabolic parameters', 'serum levels of all B vitamins measured increased: Vitamins B1', 'peroxide concentration', 'vitamin concentrations', 'homocysteine, antioxidant status, polyphenols, peroxide loading and peroxidase activity', 'blood levels of the individual B vitamins', 'serum levels of vitamins B1, B9 and B12']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0681579', 'cui_str': 'Vitamin supplement'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0031179', 'cui_str': 'Peroxidases'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0031180', 'cui_str': 'Peroxides'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0005768'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",8.0,0.0702744,"In contrast, in group S only for vitamins B2 and B12 substantial increases (p < 0.05) were found.","[{'ForeName': 'Meinrad', 'Initials': 'M', 'LastName': 'Lindschinger', 'Affiliation': 'Institut für Ernährung und Stoffwechselerkrankungen, Laßnitzhöhe, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Tatzber', 'Affiliation': 'Otto Loewi Forschungszentrum, Lehrstuhl für Immunologie und Pathophysiologie, Medizinische Universität Graz, Graz, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schimetta', 'Affiliation': 'Abteilung für Angewandte Systemforschung und Statistik, Johannes Kepler Universität Linz, Linz, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmid', 'Affiliation': 'Institut für Ernährung und Stoffwechselerkrankungen, Laßnitzhöhe, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lindschinger', 'Affiliation': 'Institut für Ernährung und Stoffwechselerkrankungen, Laßnitzhöhe, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Cvirn', 'Affiliation': 'Otto Loewi Forschungszentrum, Lehrstuhl für Physiologische Chemie, Medizinische Universität Graz, Neue Stiftingtalstraße 6 M1/D3, A-8010, Graz, Austria.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Fuchs', 'Affiliation': 'Institut für Nährstofftherapie, Lungau, Austria.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Markolin', 'Affiliation': 'Institut für Nährstofftherapie, Lungau, Austria.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Lamont', 'Affiliation': 'Klinische Abteilung für Gefäßforschung, Universitätsklinik für Chirurgie, Medizinische Universität Graz, Graz, Austria.'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Wonisch', 'Affiliation': 'Otto Loewi Forschungszentrum, Lehrstuhl für Physiologische Chemie, Medizinische Universität Graz, Neue Stiftingtalstraße 6 M1/D3, A-8010, Graz, Austria. willibald.wonisch@medunigraz.at.'}]",MMW Fortschritte der Medizin,['10.1007/s15006-020-0230-4']
3439,30527733,Evaluation of an intervention supporting breastfeeding among late-preterm infants during in-hospital stay.,"BACKGROUND


Late-preterm infants show lower breastfeeding rates when compared with term infants. Current practice is to keep them in low-risk wards where clinical guidelines to support breastfeeding are well established for term infants but can be insufficient for late-preterm.
OBJECTIVE


The aim of this study was to evaluate an intervention supporting breastfeeding among late-preterm infants in a maternity service in the Basque Country, Spain.
METHODS


The intervention was designed to promote parents' education and involvement, provide a multidisciplinary approach and decision-making, and avoid separation of the mother-infant dyad. A quasi-experimental study was conducted with a control (n=212) and an intervention group (n=161). Data was collected from clinical records from November 2012 to January 2015. Feeding rate at discharge, breast-pump use, incidence of morbidities, infant weight loss and hospital stay length were compared between the two groups.
RESULTS


Infants in the control group were 50.7% exclusive breastfeeding, 37.8% breastfeeding, and, 11.5% formula feeding at discharge, whereas in the intervention group, frequencies were 68.4%, 25.9%, and 5.7%, respectively (p=0.002). Mothers in the intervention group were 2.66 times more likely to use the breast-pump after almost all or all feeds and 2.09 times more likely to exclusively breastfeed at discharge. There were no significant differences in morbidities and infant weight loss between groups. Hospital stay was longer for infants who required phototherapy in the intervention group (p=0.009).
CONCLUSION


The intervention resulted in a higher breastfeeding rate at discharge. Interventions aimed to provide specific support among late-pretem infants in maternity services are effective.",2020,Mothers in the intervention group were 2.66 times more likely to use the breast-pump after almost all or all feeds and 2.09 times more likely to exclusively breastfeed at discharge.,"['Data was collected from clinical records from November 2012 to January 2015', 'late-preterm infants during in-hospital stay', 'late-preterm infants in a maternity service in the Basque Country, Spain', 'late-pretem infants in maternity services']",[],"['morbidities and infant weight loss', 'Feeding rate at discharge, breast-pump use, incidence of morbidities, infant weight loss and hospital stay length', 'breastfeeding rates', '2.66 times more likely to use the breast-pump', 'Hospital stay']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0337796', 'cui_str': 'Basques (ethnic group)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0182541', 'cui_str': 'Breast pump (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}]",,0.0957422,Mothers in the intervention group were 2.66 times more likely to use the breast-pump after almost all or all feeds and 2.09 times more likely to exclusively breastfeed at discharge.,"[{'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Estalella', 'Affiliation': 'Nursing Department I, Faculty of Medicine and Nursing, University of the Basque Country UPV/EHU, Barrio Sarriena s/n, 48940 Leioa, Spain; Maternal-fetal group, Biocruces Health Research Institute, Cruces University Hospital, Plaza de Cruces 12, 48903 Barakaldo, Spain. Electronic address: itziar.estalella@ehu.eus.'}, {'ForeName': 'Jaione', 'Initials': 'J', 'LastName': 'San Millán', 'Affiliation': 'Nursing Department I, Faculty of Medicine and Nursing, University of the Basque Country UPV/EHU, Barrio Sarriena s/n, 48940 Leioa, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Trincado', 'Affiliation': 'Maternal-fetal group, Biocruces Health Research Institute, Cruces University Hospital, Plaza de Cruces 12, 48903 Barakaldo, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Maquibar', 'Affiliation': 'Nursing Department I, Faculty of Medicine and Nursing, University of the Basque Country UPV/EHU, Barrio Sarriena s/n, 48940 Leioa, Spain.'}, {'ForeName': 'Lorea', 'Initials': 'L', 'LastName': 'Martínez-Indart', 'Affiliation': 'Bioinformatics and Statistical Support Unit, Biocruces Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'San Sebastián', 'Affiliation': 'Epidemiology and Global Health, Department of Public Health and Clinical Medicine, Umeå University, Sweden.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2018.11.003']
3440,31833570,Treatment of dehiscence-type defects with collagen matrix and/or enamel matrix derivative: Histomorphometric study in minipigs.,"BACKGROUND


This study aimed to evaluate, histomorphometrically, the use of collagen matrix (CM) and/or enamel matrix derivative (EMD) for the treatment of dehiscence-type recession defects in minipigs.
METHODS


Eight healthy, male, young BR-1 minipigs, with no periodontal disease were treated. Bilateral dehiscence-type defects were surgically created on the buccal of the mandibular premolars (PI and PII). After 30 days, the defects were randomly assigned to four groups: coronally advanced flap (CAF); CAF + CM; CAF + EMD; and CAF + CM + EMD (split-mouth design). The evaluated parameters (mm): total defect length; new cementum (NC); new bone (NB); gingival margin position; total epithelium length; epithelium on the root; connective tissue adaptation; and soft tissue thickness (STT).
RESULTS


The EMD-treated groups showed a superior length of NC [4.13 ± 1.22 (CAF + EMD); 3.95 ± 1.11 (CAF + CM + EMD); 2.94 ± 0.77 (CAF + CM); 2.72 ± 0.81 (CAF), P = 0.02] and NB [3.21 ± 0.68 (CAF + CM + EMD); 3.01 ± 0.56 (CAF + EMD); 2.15 ± 0.47 (CAF + CM); 2.29 ± 0.82 (CAF), P = 0.005]. The CAF and CAF + CM groups showed a superior epithelial length when compared to EMD-treated groups after 3 months. A superior STT was observed for CAF + CM + EMD group (1.5 ± 0.33) when compared with the other groups [1.09 ± 0.26 (CAF + EMD); 1.04 ± 0.34 (CAF + CM); and 1.14 ± 0.29 (CAF), P = 0.03].
CONCLUSION(S)


The results of the present study indicate that EMD application, irrespective of the combination with CM, may improve the periodontal regeneration of dehiscence-type defects in this animal model.",2020,The CAF and CAF + CM groups showed a superior epithelial length when compared to EMD-treated groups after 3 months.,"['dehiscence-type recession defects in minipigs', 'Eight healthy, male, young BR-1 minipigs, with no periodontal disease were treated']","['coronally advanced flap (CAF); CAF + CM; CAF + EMD; and CAF + CM + EMD', 'CAF + CM + EMD', 'collagen matrix (CM) and/or enamel matrix derivative (EMD']","['Bilateral dehiscence-type defects', 'superior epithelial length', 'periodontal regeneration of dehiscence-type defects', 'total defect length; new cementum (NC); new bone (NB); gingival margin position; total epithelium length; epithelium on the root; connective tissue adaptation; and soft tissue thickness (STT']","[{'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0039011', 'cui_str': 'Minipigs'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0011343', 'cui_str': 'Cementum'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}]",8.0,0.0209352,The CAF and CAF + CM groups showed a superior epithelial length when compared to EMD-treated groups after 3 months.,"[{'ForeName': 'Isabela Lima', 'Initials': 'IL', 'LastName': 'França-Grohmann', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'João Paulo Menck', 'Initials': 'JPM', 'LastName': 'Sangiorgio', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Manuela Rocha', 'Initials': 'MR', 'LastName': 'Bueno', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Renato Corrêa Viana', 'Initials': 'RCV', 'LastName': 'Casarin', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Karina Gonzáles', 'Initials': 'KG', 'LastName': 'Silvério Ruiz', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Francisco Humberto', 'Initials': 'FH', 'LastName': 'Nociti', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Márcio Zaffalon', 'Initials': 'MZ', 'LastName': 'Casati', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Enilson Antonio', 'Initials': 'EA', 'LastName': 'Sallum', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0107']
3441,31978403,Forgetting in Alzheimer's disease: Is it fast? Is it affected by repeated retrieval?,"OBJECTIVES


Whether people with Alzheimer's Disease present with accelerated long term forgetting compared to healthy controls is still debated. Typically, accelerated long term forgetting implies testing the same participants repeatedly over several delays. This testing method raises the issue of confounding repetition effects with forgetting rates. We used a novel procedure to disentangle the two effects.
METHODS


Four short stories were presented during an initial in-person assessment of 40 patients with Alzheimer's Disease and 42 age-matched healthy controls. Our aim was for participants to reach a score of 70% correct (9 out of 13 questions) at encoding. If this criterion was not achieved after the first trial, the four stories were presented again (in a different order); participants took the 1 min filler task again and were then retested. We repeated this process until participants reached the 70% criterion or to a maximum of four trials. Cued recall memory tests were completed during follow-up telephone call(s) at different delay intervals. Study material was presented only at encoding, then probed with different question sets on all other delays. Each question set tested different sub-parts of the material. The experiment employed a mixed design. Participants were randomly allocated to either a condition without retrieval practice or a condition with retrieval practice. Participants in the condition without retrieval practice were only tested at two delays: post encoding filled delay and at one month. Participants in the condition with retrieval practice were tested at four delays: post encoding filled delay, one day, one week and one month. Our methodological design allowed us to separate the effects of retesting from the effects of delay.
RESULTS


Alzheimer's Disease patients showed a significant encoding deficit reflected in the higher number of trials required to reach criterion. Using Linear Mixed Models, we found no group by delay interactions between the post encoding filled delay retrieval and one month delays, with Alzheimer's Disease groups having a similar decline in performance to healthy controls, irrespective of testing condition. Significant condition by delay interactions were found for both groups (Alzheimer's Disease and healthy controls), with better performance at one month in the condition with retrieval practice.
CONCLUSIONS


Our data showed that Alzheimer's Disease is not characterised by accelerated long term forgetting, patients in our sample forgot at the same rate as healthy controls. Given the additional trials required by Alzheimer's patients to reach the 70% correct criterion, their memory impairment appears to be one of encoding. Moreover, Alzheimer's Disease patients benefited from repeated testing to the same extent as healthy controls. Due to our methodological design, we were also able to show that performance improved under repeated testing conditions, even with partial testing (sampling different features from each narrative on every test session/delay) in both healthy controls and Alzheimer's Disease.",2020,"Significant condition by delay interactions were found for both groups (Alzheimer's Disease and healthy controls), with better performance at one month in the condition with retrieval practice.
","[""people with Alzheimer's Disease"", ""Alzheimer's Disease patients"", ""Four short stories were presented during an initial in-person assessment of 40 patients with Alzheimer's Disease and 42 age-matched healthy controls"", ""Alzheimer's disease""]",['condition without retrieval practice or a condition with retrieval practice'],['Cued recall memory tests'],"[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0522965,"Significant condition by delay interactions were found for both groups (Alzheimer's Disease and healthy controls), with better performance at one month in the condition with retrieval practice.
","[{'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Stamate', 'Affiliation': 'Human Cognitive Neuroscience, Psychology Department, University of Edinburgh, UK; University Suor Orsola Benincasa, Naples, Italy. Electronic address: s1363074@ed.ac.uk.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Logie', 'Affiliation': 'Human Cognitive Neuroscience, Psychology Department, University of Edinburgh, UK; Centre for Cognitive Ageing and Cognitive Epidemiology, University of Edinburgh, UK.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Baddeley', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Della Sala', 'Affiliation': 'Human Cognitive Neuroscience, Psychology Department, University of Edinburgh, UK; Centre for Cognitive Ageing and Cognitive Epidemiology, University of Edinburgh, UK.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107351']
3442,32154636,The European Medicines Agency Review of Gilteritinib (Xospata) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an FLT3 Mutation.,"On October 24, 2019, a marketing authorization valid through the European Union (EU) was issued for gilteritinib monotherapy for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation. Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3 internal tandem duplication (ITD), FLT3 D835Y, and FLT3 ITD D835Y, and it induced apoptosis in leukemic cells expressing FLT3 ITD. The recommended starting dose of gilteritinib is 120 mg (three 40 mg tablets) once daily. Gilteritinib was evaluated in one, phase III, open-label, multicenter, randomized study of gilteritinib (n = 247, gilteritinib arm) versus salvage chemotherapy (n = 124, salvage chemotherapy arm) in patients with relapsed or refractory AML with FLT3 mutation. Overall survival (OS) was statistically significantly different between the two groups with a median OS of 9.3 months in the gilteritinib arm compared with 5.6 months for salvage chemotherapy (hazard ratio, 0.637; 95% confidence interval, 0.490-0.830; p = .0004 one-sided log-rank test). The most common adverse reactions with gilteritinib treatment were blood creatine phosphokinase increase, alanine aminotransferase increase, aspartate aminotransferase increase, blood alkaline phosphatase increase, diarrhea, fatigue, nausea, constipation, cough, peripheral edema, dyspnea, dizziness, hypotension, pain in extremity, asthenia, arthralgia, and myalgia. The objective of this article is to summarize the scientific review of the application leading to regulatory approval in the EU. IMPLICATIONS FOR PRACTICE: Xospata was approved in the European Union as monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation. Gilteritinib resulted in a clinically meaningful and statistically significant improvement of overall survival compared with salvage chemotherapy. At the time of the marketing authorization of gilteritinib, there were no approved standard therapies specifically for adult patients diagnosed with relapsed or refractory AML with FLT3 mutation. In terms of safety, the overall accepted safety profile was considered manageable.",2020,"Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3 internal tandem duplication (ITD), FLT3 D835Y, and FLT3 ITD D835Y, and it induced apoptosis in leukemic cells expressing FLT3 ITD.","['adult patients with relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation', 'adult patients diagnosed with relapsed or refractory AML with FLT3 mutation', 'Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an FLT3 Mutation', 'adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation', 'patients with relapsed or refractory AML with FLT3 mutation']","['salvage chemotherapy', 'gilteritinib']","['overall survival', 'blood creatine phosphokinase increase, alanine aminotransferase increase, aspartate aminotransferase increase, blood alkaline phosphatase increase, diarrhea, fatigue, nausea, constipation, cough, peripheral edema, dyspnea, dizziness, hypotension, pain in extremity, asthenia, arthralgia, and myalgia', 'Overall survival (OS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0287186', 'cui_str': 'fms-Like Tyrosine Kinase 3'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3896940', 'cui_str': 'gilteritinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0853034', 'cui_str': 'Blood creatine phosphokinase increased'}, {'cui': 'C0151905', 'cui_str': 'SGPT increased'}, {'cui': 'C0151904', 'cui_str': 'Serum glutamic-oxaloacetic transaminase increased'}, {'cui': 'C0852911', 'cui_str': 'Blood alkaline phosphatase increased'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb (finding)'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",,0.100296,"Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3 internal tandem duplication (ITD), FLT3 D835Y, and FLT3 ITD D835Y, and it induced apoptosis in leukemic cells expressing FLT3 ITD.","[{'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Tzogani', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Røshol', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Helga Haugom', 'Initials': 'HH', 'LastName': 'Olsen', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Ida B', 'Initials': 'IB', 'LastName': 'Aas', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Marianne Løiten', 'Initials': 'ML', 'LastName': 'Dalhus', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Gro Dahlseng', 'Initials': 'GD', 'LastName': 'Håkonsen', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Laila Sortvik', 'Initials': 'LS', 'LastName': 'Nilssen', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Lindberg', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Økvist', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Bjørg', 'Initials': 'B', 'LastName': 'Bolstad', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Irēna', 'Initials': 'I', 'LastName': 'Rogovska', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Natalja', 'Initials': 'N', 'LastName': 'Karpova', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Enzmann', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gisselbrecht', 'Affiliation': 'Hospital Saint Louis, Paris, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0976']
3443,31988257,' Immunising' physicians against availability bias in diagnostic reasoning: a randomised controlled experiment.,"BACKGROUND


Diagnostic errors have often been attributed to biases in physicians' reasoning. Interventions to 'immunise' physicians against bias have focused on improving reasoning processes and have largely failed.
OBJECTIVE


To investigate the effect of increasing physicians' relevant knowledge on their susceptibility to availability bias.
DESIGN, SETTINGS AND PARTICIPANTS


Three-phase multicentre randomised experiment with second-year internal medicine residents from eight teaching hospitals in Brazil.
INTERVENTIONS


Immunisation: Physicians diagnosed one of two sets of vignettes (either diseases associated with chronic diarrhoea or with jaundice) and compared/contrasted alternative diagnoses with feedback. Biasing phase (1 week later): Physicians were biased towards either inflammatory bowel disease or viral hepatitis. Diagnostic performance test: All physicians diagnosed three vignettes resembling inflammatory bowel disease, three resembling hepatitis (however, all with different diagnoses). Physicians who increased their knowledge of either chronic diarrhoea or jaundice 1 week earlier were expected to resist the bias attempt.
MAIN OUTCOME MEASUREMENTS


Diagnostic accuracy, measured by test score (range 0-1), computed for subjected-to-bias and not-subjected-to-bias vignettes diagnosed by immunised and not-immunised physicians.
RESULTS


Ninety-one residents participated in the experiment. Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45). Bias only hampered non-immunised physicians, who performed worse on subjected-to-bias than not-subjected-to-bias vignettes (difference -0.17 (95% CI -0.28 to -0.05); p=0.005); immunised physicians' accuracy did not differ (p=0.56).
CONCLUSIONS


An intervention directed at increasing knowledge of clinical findings that discriminate between similar-looking diseases decreased physicians' susceptibility to availability bias, reducing diagnostic errors, in a simulated setting. Future research needs to examine the degree to which the intervention benefits other disease clusters and performance in clinical practice.
TRIAL REGISTRATION NUMBER


68745917.1.1001.0068.",2020,"Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45).","['Ninety-one residents participated in the experiment', 'Three-phase multicentre randomised experiment with second-year internal medicine residents from eight teaching hospitals in Brazil']",[],"['Diagnostic accuracy', 'inflammatory bowel disease or viral hepatitis', 'Diagnostic performance test', 'knowledge of either chronic diarrhoea or jaundice', 'chronic diarrhoea or with jaundice']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]",[],"[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis (disorder)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea (disorder)'}, {'cui': 'C0022346', 'cui_str': 'Icterus'}]",91.0,0.0645214,"Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45).","[{'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Mamede', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands s.mamede@erasmusmc.nl.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'de Carvalho-Filho', 'Affiliation': 'Internal Medicine, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Rosa Malena Delbone', 'Initials': 'RMD', 'LastName': 'de Faria', 'Affiliation': 'Propeudeutics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Franci', 'Affiliation': 'Internal Medicine, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Maria do Patrocinio Tenorio', 'Initials': 'MDPT', 'LastName': 'Nunes', 'Affiliation': 'Internal Medicine, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ligia Maria Cayres', 'Initials': 'LMC', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Medical Education Development, UNIFENAS Medical School, Belo Horizonte, Brazil.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Biegelmeyer', 'Affiliation': 'Internal Medicine, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zwaan', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010079']
3444,31145202,Women's Health Initiative clinical trials: potential interactive effect of calcium and vitamin D supplementation with hormonal therapy on cardiovascular disease.,"OBJECTIVE


Data in humans and nonhuman primates have suggested a possible synergistic effect of vitamin D and calcium (CaD) and estrogen on the cardiovascular disease (CVD) risk factors. Using randomized trial data we explored whether the effect of menopausal hormone therapy (HT) on CVD events is modified by CaD supplementation.
METHODS


A prospective, randomized, double-blind, placebo-controlled trial was implemented among postmenopausal women in the Women's Health Initiative. A total of 27,347 women were randomized to the HT trials (0.625 mg/d of conjugated equine estrogens [CEE] alone for women without a uterus vs placebo; or 0.625 mg of CEE in addition to 2.5 mg of medroxyprogesterone acetate daily [CEE + MPA] for women with a uterus vs placebo). After 1 year, 16,089 women in the HT trial were randomized to the CaD trial and received either 1,000 mg of elemental calcium carbonate and 400 IU of vitamin D3 daily or placebo. The mean (SD) duration of follow-up after CaD randomization was 6.2 (1.3) years for the CEE trial and 4.6 (1.1) years for the CEE + MPA trial. CVD and venous thromboembolism events evaluated in this subgroup analysis included coronary heart disease, stroke, pulmonary embolism, all-cause mortality, plus select secondary endpoints (total myocardial infarction, coronary revascularization, deep venous thrombosis, cardiovascular death, and all CVD events). Time-to-event methods were used and models were fit with a Cox proportional hazards regression model.
RESULTS


In the CEE trial, CaD significantly modified the effect of CEE on stroke (P interaction = 0.04). In the CaD-placebo group, CEE's effect on stroke was harmful (hazard ratio [95% confidence interval] = 2.19[1.34-3.58]); however, it was neutral in the CaD-supplement group (hazard ratio [95% confidence interval] = 1.07[0.66-1.73]). We did not observe significant CEE-CaD interactions for coronary heart disease, total CVD events, or any of the remaining endpoints. In the CEE + MPA trial, there was no evidence that the effect of CEE + MPA on any of CVD endpoints was modified by CaD supplementation.
CONCLUSIONS


CaD did not consistently modify the effect of CEE therapy or CEE + MPA therapy on CVD events. However, the increased risk of stroke due to CEE therapy appears to be mitigated by CaD supplementation. In contrast, CaD supplementation did not influence the risk of stroke due to CEE + MPA.",2019,"In the CEE trial, CaD significantly modified the effect of CEE on stroke (P interaction = 0.04).","['27,347 women', '16,089 women in the HT trial', 'women with a uterus vs placebo', ""postmenopausal women in the Women's Health Initiative""]","['menopausal hormone therapy (HT', 'placebo', 'conjugated equine estrogens [CEE', 'CEE', 'calcium and vitamin D supplementation with hormonal therapy', 'CEE therapy or CEE + MPA therapy', 'medroxyprogesterone acetate daily [CEE + MPA', 'vitamin D and calcium (CaD) and estrogen', 'elemental calcium carbonate and 400 IU of vitamin D3 daily or placebo', 'CEE + MPA', 'CaD supplementation']","['mean (SD) duration', 'coronary heart disease, stroke, pulmonary embolism, all-cause mortality, plus select secondary endpoints (total myocardial infarction, coronary revascularization, deep venous thrombosis, cardiovascular death, and all CVD events', 'CVD and venous thromboembolism events', 'CEE-CaD interactions for coronary heart disease, total CVD events', 'CVD events', 'cardiovascular disease']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",27347.0,0.686702,"In the CEE trial, CaD significantly modified the effect of CEE on stroke (P interaction = 0.04).","[{'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of ObGyn, Reading Hospital, Reading, PA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nudy', 'Affiliation': 'Department of Internal Medicine, Penn State Hershey Medical Center, Hershey, PA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Robbins', 'Affiliation': 'UC Davis Medical Center, Sacramento, CA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, MA.""}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Department of Medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'OʼSullivan', 'Affiliation': 'Department of ObGyn, Reading Hospital, Reading, PA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Shikany', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente Center for Health Research NW, Portland, OR.'}, {'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Kelsey', 'Affiliation': 'Division of Cardiology, Saint Francis Hospital and Medical Center, Hartford, CT.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lisa W', 'Initials': 'LW', 'LastName': 'Martin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Payne', 'Affiliation': 'Office of Research Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Howard', 'Affiliation': 'MedStar Health Research Institute and Georgetown/Howard Universities Center for Clinical and Translational Science, Washington, DC.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Schnatz', 'Affiliation': 'Department of ObGyn, Reading Hospital, Reading, PA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001360']
3445,32009005,The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study.,"OBJECTIVE


The twin block, a novel nerve block that blocks the deep temporal and masseteric branches of the trigeminal nerve, has been shown to be effective in the short-term management of masticatory myofascial pain. However, little is known about its effectiveness in long-term management. The objective of this study was to assess the efficacy of the twin block in comparison with trigger point injections for the treatment of masticatory myofascial pain.
STUDY DESIGN


Forty-eight patients age 18 to 89 years were randomly assigned to the twin block group (n = 23) or the trigger point injection group (n = 25). The final analysis was based on a total number of 40 patients.
RESULTS


Mean numerical pain intensity at baseline was 6.54 ± 1.90 for the trigger point injection group and 6.47 ± 2.23 for the twin block group. At the 6th month visit, it was 1.85 ± 1.85 for the trigger point injection group and 1.85 ± 1.94 for the twin block group. There were no statistically significant differences in pain intensity between the 2 groups at baseline (P = .64) and at the 6th month follow-up (P = .45).
CONCLUSIONS


The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03870191.",2020,"The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
","['patients with masticatory myofascial pain', 'Forty-eight patients age 18 to 89 years']",['trigger point injections'],"['masticatory myofascial pain', 'pain intensity', 'Mean numerical pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0185340', 'cui_str': 'Injection of trigger points (procedure)'}]","[{'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",48.0,0.124459,"The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
","[{'ForeName': 'Sowmya', 'Initials': 'S', 'LastName': 'Ananthan', 'Affiliation': 'Assistant Professor, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA. Electronic address: Ananths1@sdm.rutgers.edu.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Kanti', 'Affiliation': 'Predoctoral Student, University of Colorado School of Dental Medicine, Aurora, CO, USA.'}, {'ForeName': 'Julyana Gomes', 'Initials': 'JG', 'LastName': 'Zagury', 'Affiliation': 'Adjunct Faculty, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}, {'ForeName': 'Samuel Y P', 'Initials': 'SYP', 'LastName': 'Quek', 'Affiliation': 'Professor, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Benoliel', 'Affiliation': 'Professor and Associate Dean for Research, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2019.09.014']
3446,31408467,A novel nutritional supplement to reduce plasma homocysteine in nonpregnant women: A randomised controlled trial in The Gambia.,"BACKGROUND


Infant DNA methylation profiles are associated with their mother's periconceptional nutritional status. DNA methylation relies on nutritional inputs for one-carbon metabolic pathways, including the efficient recycling of homocysteine. This randomised controlled trial in nonpregnant women in rural Gambia tests the efficacy of a novel nutritional supplement designed to improve one-carbon-related nutrient status by reducing plasma homocysteine, and assesses its potential future use in preconception trials.
METHODS AND FINDINGS


We designed a novel drink powder based on determinants of plasma homocysteine in the target population and tested it in a three-arm, randomised, controlled trial. Nonpregnant women aged between 18 and 45 from the West Kiang region of The Gambia were randomised in a 1:1:1 allocation to 12 weeks daily supplementation of either (a) a novel drink powder (4 g betaine, 800 μg folic acid, 5.2 μg vitamin B12, and 2.8 mg vitamin B2), (b) a widely used multiple micronutrient tablet (United Nations Multiple Micronutrient Preparation [UNIMMAP]) containing 15 micronutrients, or (c) no intervention. The trial was conducted between March and July 2018. Supplementation was observed daily. Fasted venepuncture samples were collected at baseline, midline (week 5), and endline (week 12) to measure plasma homocysteine. We used linear regression models to determine the difference in homocysteine between pairs of trial arms at midline and endline, adjusted for baseline homocysteine, age, and body mass index (BMI). Blood pressure and pulse were measured as secondary outcomes. Two hundred and ninety-eight eligible women were enrolled and randomised. Compliance was >97.8% for both interventions. At endline (our primary endpoint), the drink powder and UNIMMAP reduced mean plasma homocysteine by 23.6% (-29.5 to -17.1) and 15.5% (-21.2 to -9.4), respectively (both p < 0.001), compared with the controls. Compared with UNIMMAP, the drink powder reduced mean homocysteine by 8.8% (-15.8 to -1.2; p = 0.025). The effects were stronger at midline. There was no effect of either intervention on blood pressure or pulse compared with the control at endline. Self-reported adverse events (AEs) were similar in both intervention arms. There were two serious AEs reported over the trial duration, both in the drink powder arm, but judged to be unrelated to the intervention. Limitations of the study include the use of a single targeted metabolic outcome, homocysteine.
CONCLUSIONS


The trial confirms that dietary supplements can influence metabolic pathways that we have shown in previous studies to predict offspring DNA methylation. Both supplements reduced homocysteine effectively and remain potential candidates for future epigenetic trials in pregnancy in rural Gambia.
TRIAL REGISTRATION


Clinicaltrials.gov Reference NCT03431597.",2019,"Compared with UNIMMAP, the drink powder reduced mean homocysteine by 8.8% (-15.8 to -1.2; p = 0.025).","['Two hundred and ninety-eight eligible women were enrolled and randomised', 'nonpregnant women in rural Gambia tests', 'nonpregnant women', 'Nonpregnant women aged between 18 and 45 from the West Kiang region of The Gambia']","['UNIMMAP', 'novel drink powder (4 g betaine, 800 μg folic acid, 5.2 μg vitamin B12, and 2.8 mg vitamin B2), (b) a widely used multiple micronutrient tablet (United Nations Multiple Micronutrient Preparation [UNIMMAP]) containing 15 micronutrients, or (c) no intervention', 'dietary supplements']","['blood pressure or pulse', 'Blood pressure and pulse', 'Self-reported adverse events (AEs', 'Compliance', 'mean plasma homocysteine', 'plasma homocysteine', 'mean homocysteine']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016993', 'cui_str': 'Republic of the Gambia'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0325167', 'cui_str': 'Equus kiang (organism)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}]",298.0,0.29155,"Compared with UNIMMAP, the drink powder reduced mean homocysteine by 8.8% (-15.8 to -1.2; p = 0.025).","[{'ForeName': 'Philip T', 'Initials': 'PT', 'LastName': 'James', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Ousubie', 'Initials': 'O', 'LastName': 'Jawla', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Nuredin I', 'Initials': 'NI', 'LastName': 'Mohammed', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kabiru', 'Initials': 'K', 'LastName': 'Ceesay', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Fatai M', 'Initials': 'FM', 'LastName': 'Akemokwe', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Bakary', 'Initials': 'B', 'LastName': 'Sonko', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Ebrima A', 'Initials': 'EA', 'LastName': 'Sise', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Prentice', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Matt J', 'Initials': 'MJ', 'LastName': 'Silver', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1002870']
3447,31935028,Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty: The FOXTROT Randomized Clinical Trial.,"Importance


The efficacy of factor XIa inhibition for thromboprophylaxis is unknown. Osocimab is a long-acting, fully human monoclonal antibody that inhibits factor XIa.
Objective


To compare different doses of osocimab with enoxaparin and apixaban for thromboprophylaxis in patients who have undergone knee arthroplasty.
Design, Setting, and Participants


Randomized, open-label, adjudicator-blinded, phase 2 noninferiority trial with observer blinding for osocimab doses, conducted at 54 hospitals in 13 countries. Adult patients undergoing unilateral knee arthroplasty were randomized from October 2017 through August 2018 and followed up until January 2019.
Interventions


Single intravenous osocimab postoperative doses of 0.3 mg/kg (n = 107), 0.6 mg/kg (n = 65), 1.2 mg/kg (n = 108), or 1.8 mg/kg (n = 106); preoperative doses of 0.3 mg/kg (n = 109) or 1.8 mg/kg (n = 108); or 40 mg of subcutaneous enoxaparin once daily (n = 105) or 2.5 mg of oral apixaban twice daily (n = 105) for at least 10 days or until venography.
Main Outcomes and Measures


The primary outcome was venous thromboembolism incidence between 10 and 13 days postoperatively (assessed by mandatory bilateral venography performed 10 to 13 days after surgery or confirmed symptomatic deep vein thrombosis or pulmonary embolism). A 5% noninferiority margin compared with enoxaparin was chosen. The primary safety outcome of major or clinically relevant nonmajor bleeding was assessed until 10 to 13 days postoperatively.
Results


Of 813 randomized participants (mean [SD] age, 66.5 years [8.2 years]; body mass index, 32.7 [5.7]; and 74.2% women), 600 were included in the per-protocol population used for the primary analysis. The primary outcome occurred in 18 patients (23.7%) receiving 0.3 mg/kg, 8 (15.7%) receiving 0.6 mg/kg, 13 (16.5%) receiving 1.2 mg/kg, and 14 (17.9%) receiving 1.8 mg/kg of osocimab postoperatively; 23 (29.9%) receiving 0.3 mg/kg and 9 (11.3%) receiving 1.8 mg/kg of osocimab preoperatively; 20 (26.3%) receiving enoxaparin; and 12 (14.5%) receiving apixaban. Osocimab given postoperatively met criteria for noninferiority compared with enoxaparin with risk differences (1-sided 95% CIs) of 10.6% (95% CI, -1.2% to ∞) at the 0.6-mg/kg dose; 9.9% (95% CI, -0.9% to ∞) at the 1.2-mg/kg dose, and 8.4% (95% CI, -2.6 to ∞) at the 1.8-mg/kg dose. The preoperative dose of 1.8 mg/kg of osocimab met criteria for superiority compared with enoxaparin with a risk difference of 15.1%; 2-sided 90% CI, 4.9% to 25.2%). Postoperative and preoperative doses of 0.3 mg/kg of osocimab did not meet the prespecified criteria for noninferiority, with risk differences (1-sided 95% CIs) of 2.6% (95% CI, -8.9% to ∞) and -3.6% (95% CI, -15.5% to ∞), respectively. Major or clinically relevant nonmajor bleeding was observed in up to 4.7% of those receiving osocimab, 5.9% receiving enoxaparin, and 2% receiving apixaban.
Conclusions and Relevance


Among patients undergoing knee arthroplasty, postoperative osocimab 0.6 mg/kg, 1.2 mg/kg, and 1.8 mg/kg met criteria for noninferiority compared with enoxaparin, and the preoperative 1.8-mg/kg dose of osocimab met criteria for superiority compared with enoxaparin for the primary outcome of incidence of venous thromboembolism at 10 to 13 days postoperatively. Further studies are needed to establish efficacy and safety of osocimab relative to standard thromboprophylaxis.
Trial Registration


ClinicalTrials.gov Identifier: NCT03276143.",2020,"Major or clinically relevant nonmajor bleeding was observed in up to 4.7% of those receiving osocimab, 5.9% receiving enoxaparin, and 2% receiving apixaban.
","['patients undergoing knee arthroplasty', 'Patients Undergoing Knee Arthroplasty', '813 randomized participants (mean [SD] age, 66.5 years [8.2 years]; body mass index, 32.7 [5.7]; and 74.2% women), 600 were included in the per-protocol population used for the primary analysis', '54 hospitals in 13 countries', 'patients who have undergone knee arthroplasty', 'Adult patients undergoing unilateral knee arthroplasty were randomized from October 2017 through August 2018 and followed up until January 2019']","['subcutaneous enoxaparin once daily (n\u2009=\u2009105) or 2.5 mg of oral apixaban', 'enoxaparin', 'Osocimab', 'osocimab with enoxaparin and apixaban']","['Major or clinically relevant nonmajor bleeding', 'symptomatic deep vein thrombosis or pulmonary embolism', 'venous thromboembolism incidence', 'major or clinically relevant nonmajor bleeding', 'incidence of venous thromboembolism', 'Venous Thromboembolism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",813.0,0.412906,"Major or clinically relevant nonmajor bleeding was observed in up to 4.7% of those receiving osocimab, 5.9% receiving enoxaparin, and 2% receiving apixaban.
","[{'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'Department of Medicine and Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton Ontario, Canada.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': 'Center for Thrombosis and Hemostasis, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Bayer Pharmaceuticals, Leverkusen, Germany.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer Pharmaceuticals, Leverkusen, Germany.'}, {'ForeName': 'Maria C S', 'Initials': 'MCS', 'LastName': 'Freitas', 'Affiliation': 'Bayer Pharmaceuticals, Leverkusen, Germany.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Lassen', 'Affiliation': 'Department of Orthopedics, Spine Section, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Metzig', 'Affiliation': 'Bayer Pharmaceuticals, Leverkusen, Germany.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': 'University of Oklahoma Health Sciences Center, Hudson College of Public Health, Oklahoma City.'}]",JAMA,['10.1001/jama.2019.20687']
3448,32030910,Examining Heterogeneity of Outcomes in a Weight Gain Prevention Program for Young Adults.,"OBJECTIVE


This study aimed to characterize young adults who experienced significant weight gains (> 10%) over 3 years in a weight gain prevention program.
METHODS


Secondary data analysis from the Study of Novel Approaches to Weight Gain Prevention (SNAP), a randomized trial comparing two self-regulation interventions and a control arm in young adults (18-35 years; BMI 21-30.9 kg/m 2  ), was used. Large Gainers (≥ 10% of their body weight; n = 48), Small Gainers (2.6%-9.9%; n = 149), and Weight Stable participants (± 2.5%; n = 143) were compared on dimensions affecting weight gain.
RESULTS


Differences in weight gain among the three groups were significant by year 1 and subsequently increased. Those who became Large Gainers were heavier at baseline and further below their highest weight, and they reported more weight cycling than Weight Stable, with Small Gainers intermediate. Neither study arm nor pregnancy explained weight change differences among the three groups. Large Gainers reported more depressive symptoms than Weight Stable at years 1 and 2. Large Gainers were less likely to weigh themselves at least weekly at 4 months, before differences in weight gain emerged, and at years 1 and 2.
CONCLUSIONS


Large Gainers (representing almost 10% of participants) could be identified early by greater weight issues at baseline and lower use of weight gain prevention strategies.",2020,"Large Gainers were less likely to weigh themselves at least weekly at 4 months, before differences in weight gain emerged, and at years 1 and 2.
","['young adults who experienced significant weight gains (>\u200910%) over 3 years in a weight gain prevention program', 'young adults (18-35 years; BMI 21-30.9 kg/m 2  ', 'Young Adults']","['self-regulation interventions', 'Weight Gain Prevention Program', 'Weight Gain Prevention (SNAP']","['weight gain', 'depressive symptoms', 'weight cycling']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0074709', 'cui_str': 'Snap (resin)'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0385731,"Large Gainers were less likely to weigh themselves at least weekly at 4 months, before differences in weight gain emerged, and at years 1 and 2.
","[{'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Health, Behavior, and Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gorin', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Letitia H', 'Initials': 'LH', 'LastName': 'Perdue', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bahnson', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Polzien', 'Affiliation': 'Department of Health, Behavior, and Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Ferguson Robichaud', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22720']
3449,32139483,"Does mobile phone instructional video demonstrating sputum expectoration improve the sputum sample quality and quantity in presumptive pulmonary TB cases? Protocol for a prospective pragmatic non-randomised controlled trial in Karnataka state, India.","INTRODUCTION


Sputum smear microscopy is the cornerstone of tuberculosis (TB) diagnosis under the Revised National Tuberculosis Control Programme (RNTCP) in India. Instructions on how to produce a good sputum sample are a part of RNTCP training manuals, but its assessment is not emphasised. Healthcare provider's instruction to expectorate a good sputum sample has limitations. Presumptive TB patients often submit inadequate (in quantity and/or quality) sputum samples, which may result in false-negative results. Objectives of the study are, among the selected RNTCP designated microscopy centres in  Dakshina Kannada  district, Karnataka, India, (a) to assess the effectiveness of mobile phone instructional video demonstrating sputum expectoration on sputum quality and quantity and (b) to explore the mobile phone video implementation challenges as perceived by the healthcare providers.
METHODS AND ANALYSIS


This is a pragmatic, prospective, non-randomised controlled trial in two pairs of RNTCP Designated Microscopy Centres (located at secondary and primary healthcare facilities) of  Dakshina Kannada  district, India. Presumptive pulmonary TB patients aged ≥18 years will be included. We will exclude who are severely ill, blind, hearing impaired, patients who have already brought their sputum for examination, and transported sputum. In the intervention group, participants will watch a mobile phone instructional video demonstrating submission of an adequate sputum sample. The control group will follow the usual ongoing procedure for sputum submission. This study would require 406 participants for each group to achieve a power of 90% for detecting a difference of 15% between the two groups. The participant enrolment started in December 2019.
ETHICS AND DISSEMINATION


Yenepoya University Ethics Committee, Mangaluru, India, has approved the study protocol (YEC-1/158/2019). It complies with the Declaration of Helsinki, local laws, and the International Council for Harmonization-good clinical practices. Investigators will present the results in scientific forums, publish in a scientific journal, and share with RNTCP officers.
TRIAL REGISTRATION NUMBER


Clinical Trial Registry of India (CTRI/2019/06/019887).",2020,"It complies with the Declaration of Helsinki, local laws, and the International Council for Harmonization-good clinical practices.","['406 participants for each group to achieve a power of 90% for detecting a difference of 15% between the two groups', 'two pairs of RNTCP Designated Microscopy Centres (located at secondary and primary healthcare facilities) of  Dakshina Kannada  district, India', 'Presumptive pulmonary TB patients aged ≥18 years', 'patients who have already brought their sputum for examination, and transported sputum']",[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}]",[],[],2.0,0.240867,"It complies with the Declaration of Helsinki, local laws, and the International Council for Harmonization-good clinical practices.","[{'ForeName': 'Siddharudha', 'Initials': 'S', 'LastName': 'Shivalli', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK shivalli.bhu@gmail.com.'}, {'ForeName': 'Amrut', 'Initials': 'A', 'LastName': 'Hondappagol', 'Affiliation': 'Department of Public Health, Yenepoya Medical College, Yenepoya (Deemed to be University), Mangaluru, India.'}, {'ForeName': 'Kibballi Madhukeshwar', 'Initials': 'KM', 'LastName': 'Akshaya', 'Affiliation': 'Department of Community Medicine, Yenepoya Medical College, Yenepoya (Deemed to be University), Mangaluru, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Nirgude', 'Affiliation': 'Department of Community Medicine, Yenepoya Medical College, Yenepoya (Deemed to be University), Mangaluru, India.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Varun', 'Affiliation': 'Department of Community Medicine, Yenepoya Medical College, Yenepoya (Deemed to be University), Mangaluru, India.'}, {'ForeName': 'Raveendra Harohally Ramaiah', 'Initials': 'RHR', 'LastName': 'Reddy', 'Affiliation': 'Department of Community Medicine, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, India.'}, {'ForeName': 'Burugina Nagaraja', 'Initials': 'BN', 'LastName': 'Sharath', 'Affiliation': 'Department of Community Medicine, ESIC Medical College and Post Graduate Institute of Medical Sciences and Research, Bengaluru, India.'}]",BMJ open,['10.1136/bmjopen-2019-032991']
3450,32186976,Impact of Photobiomodulation on T3/T4 Ratio and Quality of Life in Hashimoto Thyroiditis.,"Objective and background:  Hashimoto's thyroiditis (HT) is both a B cell- and T cell-mediated, organ-specific autoimmune disease. No current treatment for underlying pathological mechanisms is available for HT and once diagnosed it requires long-term levothyroxine (LT 4 ) treatment in most patients. The aim of our study was to evaluate the effects of photobiomodulation (PBM) on HT patients regarding thyroid functions, thyroid autoantibody levels, and decrease in hormone replacement needs.  Methods:  A total of 350 patients, who were diagnosed with Hashimoto`s thyroiditis, were included in our study. Patients were classified into two groups. Group 1 ( n  = 210) received PBM and dietary supplementation such as vitamin D, iron, and selenium. Group 2 ( n  = 140) received dietary supplements only. Patients' needs for LT 4  replacement levels, triiodothyronine (T3), thyroxine (T4), and TSH levels, T3/T4 ratio, and thyroid autoantibody levels were evaluated.  Results:  As we compare both groups, the increase in T3 levels and T3/T4 ratio was markedly superior in Group 1 ( p  = 0.0001). The decrease in thyroid peroxidase antibody (TPO Ab) levels was also significantly different between both groups ( p  = 0.0001). Hormone replacement needs were also significantly decreased in Group 1 compared with Group 2 ( p  = 0.03). Low-level laser therapy (LLLT) is 70 times more effective in increasing T3/T4 ratio ( p  = 0.001) and 15 times more effective in decreasing levothyroxine dosage.  Conclusions:  Our results are encouraging and PBM seems to be very effective in increasing T3/T4 ratio and decreasing TPO Ab levels and weekly dosages of LT 4  replacement therapy. Anti-inflammatory properties of PBM are greatly responsible for these changes and PBM causes major improvements in HT-related symptoms of the patient.",2020,The decrease in thyroid peroxidase antibody (TPO Ab) levels was also significantly different between both groups ( p  = 0.0001).,"['350 patients, who were diagnosed with Hashimoto`s thyroiditis']","['Photobiomodulation', 'photobiomodulation (PBM', 'PBM and dietary supplementation such as vitamin D, iron, and selenium', 'dietary supplements only', ""background:  Hashimoto's thyroiditis (HT"", 'Low-level laser therapy (LLLT', 'levothyroxine']","['thyroid peroxidase antibody (TPO Ab) levels', 'T3/T4 Ratio and Quality of Life', 'T3 levels and T3/T4 ratio', 'LT 4  replacement levels, triiodothyronine (T3), thyroxine (T4), and TSH levels, T3/T4 ratio, and thyroid autoantibody levels']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040147', 'cui_str': 'Thyroiditis'}]","[{'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto Disease'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C1318460', 'cui_str': 'Measurement of thyroperoxidase antibody (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0523376', 'cui_str': 'Thyroid autoantibody test'}]",350.0,0.0992852,The decrease in thyroid peroxidase antibody (TPO Ab) levels was also significantly different between both groups ( p  = 0.0001).,"[{'ForeName': 'Candas', 'Initials': 'C', 'LastName': 'Ercetin', 'Affiliation': 'Department of General Surgery, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Nuri Alper', 'Initials': 'NA', 'LastName': 'Sahbaz', 'Affiliation': 'Department of General Surgery, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Acar', 'Affiliation': 'Department of General Surgery, Acibadem Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Firat', 'Initials': 'F', 'LastName': 'Tutal', 'Affiliation': 'Department of General Surgery, Istanbul Kolan Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Erbil', 'Affiliation': 'Department of General Surgery, Istanbul Medical Faculty, University of Istanbul, Istanbul, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4740']
3451,31940698,A Randomized Trial of Erythropoietin for Neuroprotection in Preterm Infants.,"BACKGROUND


High-dose erythropoietin has been shown to have a neuroprotective effect in preclinical models of neonatal brain injury, and phase 2 trials have suggested possible efficacy; however, the benefits and safety of this therapy in extremely preterm infants have not been established.
METHODS


In this multicenter, randomized, double-blind trial of high-dose erythropoietin, we assigned 941 infants who were born at 24 weeks 0 days to 27 weeks 6 days of gestation to receive erythropoietin or placebo within 24 hours after birth. Erythropoietin was administered intravenously at a dose of 1000 U per kilogram of body weight every 48 hours for a total of six doses, followed by a maintenance dose of 400 U per kilogram three times per week by subcutaneous injection through 32 completed weeks of postmenstrual age. Placebo was administered as intravenous saline followed by sham injections. The primary outcome was death or severe neurodevelopmental impairment at 22 to 26 months of postmenstrual age. Severe neurodevelopmental impairment was defined as severe cerebral palsy or a composite motor or composite cognitive score of less than 70 (which corresponds to 2 SD below the mean, with higher scores indicating better performance) on the Bayley Scales of Infant and Toddler Development, third edition.
RESULTS


A total of 741 infants were included in the per-protocol efficacy analysis: 376 received erythropoietin and 365 received placebo. There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P = 0.80). There were no significant differences between the groups in the rates of retinopathy of prematurity, intracranial hemorrhage, sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, or death or in the frequency of serious adverse events.
CONCLUSIONS


High-dose erythropoietin treatment administered to extremely preterm infants from 24 hours after birth through 32 weeks of postmenstrual age did not result in a lower risk of severe neurodevelopmental impairment or death at 2 years of age. (Funded by the National Institute of Neurological Disorders and Stroke; PENUT ClinicalTrials.gov number, NCT01378273.).",2020,"There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P = 0.80).","['941 infants who were born at 24 weeks 0 days to 27 weeks 6 days of gestation to receive', 'within 24 hours after birth', '741 infants were included in the per-protocol efficacy analysis: 376 received', 'Preterm Infants']","['placebo', 'Placebo', 'Erythropoietin', 'erythropoietin or placebo', 'erythropoietin']","['rates of retinopathy of prematurity, intracranial hemorrhage, sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, or death or in the frequency of serious adverse events', 'death or severe neurodevelopmental impairment', 'severe cerebral palsy or a composite motor or composite cognitive score', 'severe neurodevelopmental impairment or death', 'incidence of death or severe neurodevelopmental impairment', 'Severe neurodevelopmental impairment']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",941.0,0.767138,"There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P = 0.80).","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Wadhawan', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Kaashif A', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bendel-Stenzel', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Baserga', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Edmund F', 'Initials': 'EF', 'LastName': 'LaGamma', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'L Corbin', 'Initials': 'LC', 'LastName': 'Downey', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Fahim', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz Iii', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Janine Y', 'Initials': 'JY', 'LastName': 'Khan', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Ohls', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Perez', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'McKay', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kuban', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Hartman', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1907423']
3452,32169887,"Dietary Advanced Glycation End-products (AGE) and Risk of Breast Cancer in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).","Advanced glycation end-products (AGEs) are implicated in the pathogenesis of several chronic diseases including cancer. AGEs are produced endogenously but can also be consumed from foods. AGE formation in food is accelerated during cooking at high temperatures. Certain high fat or highly processed foods have high AGE values. The objective of the study was to assign and quantify N ϵ -carboxymethyl-lysine (CML)-AGE content in food and investigate the association between dietary AGE intake and breast cancer risk in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. The study included women enrolled in the intervention arm who were cancer-free at baseline and completed a baseline questionnaire and food frequency questionnaire (DQX). CML-AGE values were assigned and quantified to foods in the DQX using a published AGE database. Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) of breast cancer among all women, and stratified by race/ethnicity, invasiveness of disease, and hormone receptor status. After a median 11.5 years of follow-up, 1,592 women were diagnosed with breast cancer. Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HR Q5VSQ1 , 1.30; 95% CI, 1.04-1.62;  P   trend  = 0.04) and in non-Hispanic white women (HR T3VST1 , 1.21; 95% CI, 1.02-1.44). Increased CML-AGE intake was associated with increased risk of  in situ  (HR T3VST1 , 1.49; 95% CI, 1.11-2.01) and hormone receptor-positive (HR T3VST1 , 1.24; 95% CI, 1.01-1.53) breast cancers. In conclusion, high intake of dietary AGE may contribute to increased breast cancer.",2020,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","['1,592 women were diagnosed with breast cancer', 'women enrolled in the intervention arm who were cancer-free at baseline and completed a']",[],"['hormone receptor positive (HRT3 VS T1', 'Increased CML-AGE intake', 'risk of breast cancer', 'baseline questionnaire and food frequency questionnaire (DQX']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",1592.0,0.0530889,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","[{'ForeName': 'Omonefe O', 'Initials': 'OO', 'LastName': 'Omofuma', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Turner', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lindsay L', 'Initials': 'LL', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Anwar T', 'Initials': 'AT', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Steck', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. stecks@mailbox.sc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0457']
3453,32109257,An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation.,"BACKGROUND


In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators.
METHODS AND FINDINGS


We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve.
CONCLUSIONS


In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement.
TRIAL REGISTRATION


The study is registered with the ISRCTN registry (ISRCTN91989345).",2020,"The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214).","['general practices in West Yorkshire, England', 'Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients']",['randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF'],"['levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing', 'reduced co-prescription of aspirin and clopidogrel without gastro-protection', 'total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0454879', 'cui_str': 'West Yorkshire (geographic location)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2.0,0.258025,"The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214).","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Willis', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Glidewell', 'Affiliation': 'Department of Health Sciences, Hull York Medical School, University of York, York, United Kingdom.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holland', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Petty', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of Bradford, Bradford, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alderson', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Carder', 'Affiliation': 'West Yorkshire Research and Development, NHS Bradford Districts CCG, Bradford, United Kingdom.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'West Yorkshire Research and Development, NHS Bradford Districts CCG, Bradford, United Kingdom.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Foy', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003045']
3454,31601571,Rojiroti microfinance and child nutrition: a cluster randomised trial.,"OBJECTIVE


To determine whether Rojiroti microfinance, for poor Indian women, improves child nutrition.
DESIGN


Cluster randomised trial.
SETTING


Tolas (village communities) in Bihar State.
PARTICIPANTS


Women and children under 5 years.
INTERVENTIONS


With Rojiroti microfinance, women form self-help groups and save their money to provide loans to group members. After 6 months, they receive larger external loans. Tolas were randomised to receive Rojiroti immediately or after 18 months.
OUTCOME MEASURES


The primary analysis compared the mean weight for height Z score (WHZ) of children under 5 years in the intervention versus control tolas who attended for weight and height measurement 18 months after randomisation. Secondary outcomes were weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting.
RESULTS


We randomised 28 tolas to each arm and collected data from 2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up. At 18 months, mean WHZ was significantly higher for intervention (-1.02) versus controls (-1.37; regression coefficient adjusted for clustering β = 0.38, 95% CI 0.16 to 0.61, p=0.001). Significantly fewer children were wasted in the intervention group (122, 18%) versus control (200, 29%; OR=0.46, 95% CI 0.28 to 0.74, p=0.002). Mean WAZ was better in the intervention group (-2.13 vs -2.37; β = 0.27, 95% CI 0.11 to 0.43, p=0.001) as was MUAC (13.6 cm vs 13.4 cm; β = 0.22, 95% CI 0.03 to 0.40, p=0.02). In an analysis adjusting for baseline nutritional measures (259 intervention children and 300 control), only WAZ and % underweight showed significant differences in favour of the intervention.
CONCLUSION


In marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.
TRIAL REGISTRATION NUMBER


NCT01845545.",2020,"In marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.
","['Tolas', 'village communities) in Bihar State', 'Rojiroti microfinance and child nutrition', 'Women and children under 5 years', '1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up', '2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up', 'poor Indian women, improves child nutrition']","['WHZ', 'Rojiroti microfinance']","['weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting', 'mean WHZ', 'mean weight for height Z score (WHZ', 'Mean WAZ']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1720755', 'cui_str': 'Child Nutritional Physiology Phenomena'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}]",1326.0,0.187303,"In marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.
","[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Ojha', 'Affiliation': 'Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Szatkowski', 'Affiliation': 'Division of Epidemiology & Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ranjeet', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Community Medicine, Patna Medical College, Patna, Bihar, India.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yaron', 'Affiliation': 'GY Associates Ltd and Trustee, Harpenden, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fogarty', 'Affiliation': 'Division of Epidemiology & Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Stephen John', 'Initials': 'SJ', 'LastName': 'Allen', 'Affiliation': 'Department of Child Health, The Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'Centre for Promoting Sustainable Livelihood (CPSL), Patna, Bihar, India.'}, {'ForeName': 'Alan Robert', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, Nottingham University, Nottingham, UK alan.smyth@nottingham.ac.uk.'}]",Archives of disease in childhood,['10.1136/archdischild-2018-316471']
3455,31623675,Oral vitamin C supplementation to patients with myeloid cancer on azacitidine treatment: Normalization of plasma vitamin C induces epigenetic changes.,"BACKGROUND


Patients with haematological malignancies are often vitamin C deficient, and vitamin C is essential for the TET-induced conversion of 5-methylcytosine (5mC) to 5-hydroxymethylcytosine (5hmC), the first step in active DNA demethylation. Here, we investigate whether oral vitamin C supplementation can correct vitamin C deficiency and affect the 5hmC/5mC ratio in patients with myeloid cancers treated with DNA methyltransferase inhibitors (DNMTis).
RESULTS


We conducted a randomized, double-blinded, placebo-controlled pilot trial (NCT02877277) in Danish patients with myeloid cancers performed during 3 cycles of DNMTi-treatment (5-azacytidine, 100 mg/m 2 /d for 5 days in 28-day cycles) supplemented by oral dose of 500 mg vitamin C (n = 10) or placebo (n = 10) daily during the last 2 cycles. Fourteen patients (70%) were deficient in plasma vitamin C (< 23 μM) and four of the remaining six patients were taking vitamin supplements at inclusion. Global DNA methylation was significantly higher in patients with severe vitamin C deficiency (< 11.4 μM; 4.997 vs 4.656% 5mC relative to deoxyguanosine, 95% CI [0.126, 0.556], P = 0.004). Oral supplementation restored plasma vitamin C levels to the normal range in all patients in the vitamin C arm (mean increase 34.85 ± 7.94 μM, P = 0.0004). We show for the first time that global 5hmC/5mC levels were significantly increased in mononuclear myeloid cells from patients receiving oral vitamin C compared to placebo (0.037% vs - 0.029%, 95% CI [- 0.129, - 0.003], P = 0.041).
CONCLUSIONS


Normalization of plasma vitamin C by oral supplementation leads to an increase in the 5hmC/5mC ratio compared to placebo-treated patients and may enhance the biological effects of DNMTis. The clinical efficacy of oral vitamin C supplementation to DNMTis should be investigated in a large randomized, placebo-controlled clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02877277 . Registered on 9 August 2016, retrospectively registered.",2019,"Global DNA methylation was significantly higher in patients with severe vitamin C deficiency (< 11.4 μM; 4.997 vs 4.656% 5mC relative to deoxyguanosine, 95% CI [0.126, 0.556], P = 0.004).","['Patients with\xa0haematological malignancies', 'patients with myeloid cancer on azacitidine treatment', 'patients with\xa0myeloid cancers treated with DNA methyltransferase inhibitors (DNMTis', 'Danish patients with\xa0myeloid cancers']","['Oral vitamin C supplementation', 'vitamin C', 'placebo', 'oral vitamin C supplementation', 'vitamin supplements', 'DNMTi-treatment (5-azacytidine, 100', 'oral vitamin C']","['5hmC/5mC ratio', 'Global DNA methylation', 'plasma vitamin C', 'plasma vitamin C levels', 'global 5hmC/5mC levels', 'mononuclear myeloid cells']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C4522039', 'cui_str': 'Methyltransferase inhibitor'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0681579', 'cui_str': 'Vitamin supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0887899', 'cui_str': 'Myeloid Cells'}]",,0.621756,"Global DNA methylation was significantly higher in patients with severe vitamin C deficiency (< 11.4 μM; 4.997 vs 4.656% 5mC relative to deoxyguanosine, 95% CI [0.126, 0.556], P = 0.004).","[{'ForeName': 'Linn', 'Initials': 'L', 'LastName': 'Gillberg', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen Biocenter, Building 2, 3rd floor, Ole Maaløes Vej 5, DK-2200, Copenhagen, Denmark.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Ørskov', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen Biocenter, Building 2, 3rd floor, Ole Maaløes Vej 5, DK-2200, Copenhagen, Denmark.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Nasif', 'Affiliation': 'MRC London Institute of Medical Sciences (LMS), Imperial College, London, UK.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ohtani', 'Affiliation': 'Van Andel Research Institute, Grand Rapids, MI, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Madaj', 'Affiliation': 'Van Andel Research Institute, Grand Rapids, MI, USA.'}, {'ForeName': 'Jakob W', 'Initials': 'JW', 'LastName': 'Hansen', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen Biocenter, Building 2, 3rd floor, Ole Maaløes Vej 5, DK-2200, Copenhagen, Denmark.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rapin', 'Affiliation': 'Biotech Research and Innovation Centre (BRIC), Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Johanne B', 'Initials': 'JB', 'LastName': 'Mogensen', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen Biocenter, Building 2, 3rd floor, Ole Maaløes Vej 5, DK-2200, Copenhagen, Denmark.'}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Van Andel Research Institute, Grand Rapids, MI, USA.'}, {'ForeName': 'Inge H', 'Initials': 'IH', 'LastName': 'Dufva', 'Affiliation': 'Department of Haematology, Herlev University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lykkesfeldt', 'Affiliation': 'Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hajkova', 'Affiliation': 'MRC London Institute of Medical Sciences (LMS), Imperial College, London, UK.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Jones', 'Affiliation': 'Van Andel Research Institute, Grand Rapids, MI, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen Biocenter, Building 2, 3rd floor, Ole Maaløes Vej 5, DK-2200, Copenhagen, Denmark. kirsten.groenbaek@regionh.dk.'}]",Clinical epigenetics,['10.1186/s13148-019-0739-5']
3456,31999862,An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge.,"BACKGROUND


Food allergy diagnosis in clinical studies can be challenging. Oral food challenges (OFC) are time-consuming, carry some risk and may, therefore, not be acceptable to all study participants.
OBJECTIVE


To design and evaluate an algorithm for detecting IgE-mediated food allergy in clinical study participants who do not undergo OFC.
METHODS


An algorithm for trial participants in the Barrier Enhancement for Eczema Prevention (BEEP) study who were unwilling or unable to attend OFC was developed. BEEP is a pragmatic, multi-centre, randomized-controlled trial of daily emollient for the first year of life for primary prevention of eczema and food allergy in high-risk infants (ISRCTN21528841). We built on the European iFAAM consensus guidance to develop a novel food allergy diagnosis algorithm using available information on previous allergenic food ingestion, food reaction(s) and sensitization status. This was implemented by a panel of food allergy experts blind to treatment allocation and OFC outcome. We then evaluated the algorithm's performance in both BEEP and Enquiring About Tolerance (EAT) study participants who did undergo OFC.
RESULTS


In 31/69 (45%) BEEP and 44/55 (80%) EAT study control group participants who had an OFC the panel felt confident enough to categorize children as ""probable food allergy"" or ""probable no food allergy"". Algorithm-derived panel decisions showed high sensitivity 94% (95%CI 68, 100) BEEP; 90% (95%CI 72, 97) EAT and moderate specificity 67% (95%CI 39, 87) BEEP; 67% (95%CI 39, 87) EAT. Sensitivity and specificity were similar when all BEEP and EAT participants with OFC outcome were included.
CONCLUSION


We describe a new algorithm with high sensitivity for IgE-mediated food allergy in clinical study participants who do not undergo OFC.
CLINICAL RELEVANCE


This may be a useful tool for excluding food allergy in future clinical studies where OFC is not conducted.",2020,"Algorithm-derived panel decisions showed high sensitivity 94% (95%CI 68, 100) BEEP; 90% (95%CI 72, 97) EAT and moderate specificity 67% (95%CI 39, 87) BEEP; 67% (95%CI 39, 87) EAT.","['study participants who do not undergo food challenge', 'clinical study participants who do not undergo OFC', ""clinical study participants who don't undergo OFC"", 'study participants who did undergo OFC']","['BEEP', 'BEEP and Enquiring About Tolerance (EAT']",['Sensitivity and specificity'],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.249941,"Algorithm-derived panel decisions showed high sensitivity 94% (95%CI 68, 100) BEEP; 90% (95%CI 72, 97) EAT and moderate specificity 67% (95%CI 39, 87) BEEP; 67% (95%CI 39, 87) EAT.","[{'ForeName': 'Maeve M', 'Initials': 'MM', 'LastName': 'Kelleher', 'Affiliation': 'Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Jay', 'Affiliation': ""Children's Allergy Dept., Sheffield Children's NHS Foundation Trust, Sheffield, UK.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Haines', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Batt', 'Affiliation': ""Children's Allergy Service, Evelina Children's Hospital London, London, UK.""}, {'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Bradshaw', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Boyle', 'Affiliation': 'Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, London, UK.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13577']
3457,32001493,PERCEPT myeloma: a protocol for a pilot randomised controlled trial of exercise prehabilitation before and during autologous stem cell transplantation in patients with multiple myeloma.,"INTRODUCTION


Myeloma, a blood cancer originating from plasma cells, is the most common indication for autologous stem cell transplantation (SCT). Patients with myeloma undergoing autologous SCT (ASCT) experience treatment-related morbidity and reduction in function and well-being for many months post-treatment. Interventions targeting physical functioning delivered prior to and during SCT have shown promising results in mixed haematological populations and may offer a non-pharmacological solution to physically optimising and preparing patients for SCT. The aim of this study is to investigate the feasibility of a physiotherapist-led exercise intervention as an integral part of the myeloma ASCT pathway at a UK tertiary centre.
METHODS AND ANALYSIS


PERCEPT is a single-site, pilot randomised controlled trial of an exercise intervention embedded within the myeloma ASCT pathway, compared with usual care. The primary study end points will be feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events. Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity. Outcomes will be assessed at four time points, approximately 6-8 weeks prior to SCT, on/around day of SCT, on discharge from SCT hospital admission and 12 weeks post-discharge. The exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques to promote change in exercise behaviour. The primary outcomes from the trial will be summarised as percentages or mean values with 95% CIs. Group differences for secondary outcomes at each time point will be analysed using appropriate statistical models.
ETHICS AND DISSEMINATION


This study has NHS REC approval (Camden and Kings Cross, 19/LO/0204). Results will be disseminated through publication and presentations at haematology and rehabilitation-related meetings.
TRIAL REGISTRATION NUMBER


ISRCTN15875290.",2020,"Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity.","['Patients with myeloma undergoing', 'patients with multiple myeloma']","['exercise intervention', 'autologous stem cell transplantation', 'physiotherapist-led exercise intervention', 'exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques', 'autologous SCT (ASCT']","['feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events', 'cancer-related fatigue, quality of life, functional capacity (6\u2009min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.162006,"Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity.","[{'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'McCourt', 'Affiliation': 'Therapies & Rehabilitation, University College London Hospitals NHS Foundation Trust, London, UK o.mccourt@nhs.net.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'Research Department of Behavoural Science and Health, University College London, London, UK.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramdharry', 'Affiliation': 'Queen Square Centre for Neuromuscular Diseases, University College London, London, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Roberts', 'Affiliation': 'Research Department of Behavoural Science and Health, University College London, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Land', 'Affiliation': 'Research Department of Behavoural Science and Health, University College London, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Rabin', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Research Department of Haematology, Cancer Institute, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033176']
3458,31636172,Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors.,"Coronary artery disease (CAD) is more frequent among individuals with dysglycemia. Preventive interventions for diabetes can improve cardiometabolic risk factors (CRFs), but it is unclear whether the benefits on CRFs are similar for individuals at different genetic risk for CAD. We built a 201-variant polygenic risk score (PRS) for CAD and tested for interaction with diabetes prevention strategies on 1-year changes in CRFs in 2,658 Diabetes Prevention Program (DPP) participants. We also examined whether separate lifestyle behaviors interact with PRS and affect changes in CRFs in each intervention group. Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared with placebo ( P  < 0.001) irrespective of CAD genetic risk ( P   interaction  > 0.05). We detected nominal significant interactions between PRS and dietary quality and physical activity on 1-year change in BMI, fasting glucose, triglycerides, and HDL cholesterol in individuals randomized to metformin or placebo, but none of them achieved the multiple-testing correction for significance. This study confirms that diabetes preventive interventions improve CRFs regardless of CAD genetic risk and delivers hypothesis-generating data on the varying benefit of increasing physical activity and improving diet on intermediate cardiovascular risk factors depending on individual CAD genetic risk profile.",2020,Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared to placebo ( P <0.001) irrespective of CAD genetic risk ( P   int >0.05).,"['2,658 Diabetes Prevention Program participants', 'individuals with dysglycemia']","['placebo', 'metformin']","['CAD genetic risk', 'majority of recognized CRFs', 'Coronary artery disease (CAD', 'PRS and dietary quality and physical activity on one-year change in body mass index, fasting glucose, triglycerides, and HDLc']","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",2658.0,0.0257923,Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared to placebo ( P <0.001) irrespective of CAD genetic risk ( P   int >0.05).,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Merino', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Jablonski', 'Affiliation': 'The Biostatistics Center, Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Mercader', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Maegan', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Genomics Platform, Eli and Edythe L. Broad Institute of MIT and Harvard, Cambridge, MA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Maria Rosario G', 'Initials': 'MRG', 'LastName': 'Araneta', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Walford', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Suzanne B R', 'Initials': 'SBR', 'LastName': 'Jacobs', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Uzoma N', 'Initials': 'UN', 'LastName': 'Ibebuogu', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, The University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Genetic & Molecular Epidemiology Unit, Lund University Diabetes Centre, Malmo, Sweden.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Florez', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0097']
3459,31644499,Male Partner Linkage to Clinic-Based Services for Sexually Transmitted Infections and Human Immunodeficiency Virus Services Following Couple Home-Based Education and Testing.,"BACKGROUND


Home-based human immunodeficiency virus (HIV) testing and education has increased HIV test uptake and access to health services among men. We studied how a home-based antenatal intervention influenced male partner utilization of clinic-based HIV and sexually transmitted infection (STI) services, linkage to HIV care and medical circumcision.
METHODS


We conducted a secondary analysis within a randomized controlled trial of pregnant women attending antenatal care in Kenya. Women and their male partners received either a home-based couple intervention or an invitation letter for clinic-based couple HIV testing. The home-based intervention included education on STI symptoms, STI and HIV treatment and male circumcision for HIV prevention. Male self-reported outcomes were compared using relative risks at 6 months postpartum.
RESULTS


Among 525 women, we reached 487 (93%) of their male partners; 247 men in the intervention arm and 240 men in the control arm. Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89). Among 23 men with newly diagnosed HIV, linkage to HIV care was reported by 4 of 15 in the intervention (3 men had missing linkage data) and 3 of 5 men in the control arms (relative risk, 0.66; 95% confidence interval, 0.34-1.29). Although the intervention identified 3 times more men with new HIV infection, the study lacked power to find significant differences in linkage to HIV care. Few eligible men sought medical circumcision (4 of 72 intervention and 2 of 88 control).
CONCLUSIONS


Home-based couple education and testing increased STI consultations among male partners of pregnant women, but appeared insufficient to overcome the barriers involved in linkage to HIV care and medical circumcision.",2019,"Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89).","['23 men with newly diagnosed HIV', 'pregnant women attending antenatal care in Kenya', 'Women and their male partners', 'Male Partner Linkage to Clinic-Based Services for Sexually Transmitted Infections and Human Immunodeficiency Virus Services', 'Few eligible men sought medical circumcision (4 of 72 intervention and 2 of 88 control', 'male partners of pregnant women', '525 women, we reached 487 (93%) of their male partners; 247 men in the intervention arm and 240 men in the control arm', 'men']","['home-based couple intervention or an invitation letter for clinic-based couple HIV testing', 'home-based antenatal intervention']","['male partner utilization of clinic-based HIV and sexually transmitted infection (STI) services', 'likely to report an STI consultation', 'STI consultations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",525.0,0.0621027,"Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mark', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Department of Research and Programs.'}, {'ForeName': 'Alfred O', 'Initials': 'AO', 'LastName': 'Osoti', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Gone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Nairobi.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Asila', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Nairobi.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Krakowiak', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Saloni', 'Initials': 'S', 'LastName': 'Parikh', 'Affiliation': 'Computer Science and Engineering and Public Health.'}, {'ForeName': 'Quy T', 'Initials': 'QT', 'LastName': 'Ton', 'Affiliation': 'Allina Health, Minneapolis, MN.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Roxby', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001057']
3460,32049269,Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension: A Randomized Clinical Trial.,"Importance


Vasopressors are commonly administered to intensive care unit (ICU) patients to raise blood pressure. Balancing risks and benefits of vasopressors is a challenge, particularly in older patients.
Objective


To determine whether reducing exposure to vasopressors through permissive hypotension (mean arterial pressure [MAP] target, 60-65 mm Hg) reduces mortality at 90 days in ICU patients aged 65 years or older with vasodilatory hypotension.
Design, Setting, and Participants


A multicenter, pragmatic, randomized clinical trial was conducted in 65 ICUs in the United Kingdom and included 2600 randomized patients aged 65 years or older with vasodilatory hypotension (assessed by treating clinician). The study was conducted from July 2017 to March 2019, and follow-up was completed in August 2019.
Interventions


Patients were randomized 1:1 to vasopressors guided either by MAP target (60-65 mm Hg, permissive hypotension) (n = 1291) or according to usual care (at the discretion of treating clinicians) (n = 1307).
Main Outcome and Measures


The primary clinical outcome was all-cause mortality at 90 days.
Results


Of 2600 randomized patients, after removal of those who declined or had withdrawn consent, 2463 (95%) were included in the analysis of the primary outcome (mean [SD] age 75 years [7 years]; 1387 [57%] men). Patients randomized to the permissive hypotension group had lower exposure to vasopressors compared with those in the usual care group (median duration 33 hours vs 38 hours; difference in medians, -5.0; 95% CI, -7.8 to -2.2 hours; total dose in norepinephrine equivalents median, 17.7 mg vs 26.4 mg; difference in medians, -8.7 mg; 95% CI, -12.8 to -4.6 mg). At 90 days, 500 of 1221 (41.0%) in the permissive hypotension compared with 544 of 1242 (43.8%) in the usual care group had died (absolute risk difference, -2.85%; 95% CI, -6.75 to 1.05; P = .15) (unadjusted relative risk, 0.93; 95% CI, 0.85-1.03). When adjusted for prespecified baseline variables, the odds ratio for 90-day mortality was 0.82 (95% CI, 0.68 to 0.98). Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group. The most common serious adverse events were acute renal failure (41 [3.2%] vs 33 [2.5%]) and supraventricular cardiac arrhythmia (12 [0.9%] vs 13 [1.0%]).
Conclusions and Relevance


Among patients 65 years or older receiving vasopressors for vasodilatory hypotension, permissive hypotension compared with usual care did not result in a statistically significant reduction in mortality at 90 days. However, the confidence interval around the point estimate for the primary outcome should be considered when interpreting the clinical importance of the study.
Trial Registration


isrctn.org Identifier: ISRCTN10580502.",2020,Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group.,"['July 2017 to March 2019, and follow-up was completed in August 2019', 'ICU patients aged 65 years or older with vasodilatory hypotension', 'patients 65 years or older receiving vasopressors for vasodilatory hypotension, permissive hypotension', '2600 randomized patients, after removal of those who declined or had withdrawn consent, 2463 (95%) were included in the analysis of the primary outcome (mean [SD] age 75 years [7 years]; 1387 [57%] men', '65 ICUs in the United Kingdom and included 2600 randomized patients aged 65 years or older with vasodilatory hypotension (assessed by treating clinician', 'older patients', 'Older Critically Ill Patients With Vasodilatory Hypotension']","['vasopressors guided either by MAP target (60-65 mm Hg, permissive hypotension) (n\u2009=\u20091291) or according to usual care (at the discretion of treating clinicians', 'Reduced Exposure to Vasopressors', 'permissive hypotension']","['lower exposure to vasopressors', 'mortality', 'odds ratio for 90-day mortality', 'acute renal failure', 'cause mortality', 'supraventricular cardiac arrhythmia', 'permissive hypotension', 'Serious adverse events', '90-Day Mortality']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3645573', 'cui_str': 'Map target'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2600.0,0.284356,Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'M Zia', 'Initials': 'MZ', 'LastName': 'Sadique', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Grieve', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Camsooksai', 'Affiliation': 'Critical Care, Poole Hospital NHS Foundation Trust, Poole, Dorset, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Darnell', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Henry', 'Affiliation': 'Patient representative, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hudson', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Alexina J', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Saull', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Whitman', 'Affiliation': 'Patient representative, United Kingdom.'}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Kadoorie Centre for Critical Care Research and Education, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.0930']
3461,31981713,High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial.,"INTRODUCTION


Phase 2 clinical trials of tuberculosis treatment have shown that once-daily regimens in which rifampin is replaced by high dose rifapentine have potent antimicrobial activity that may be sufficient to shorten overall treatment duration. Herein we describe the design of an ongoing phase 3 clinical trial testing the hypothesis that once-daily regimens containing high dose rifapentine in combination with other anti-tuberculosis drugs administered for four months can achieve cure rates not worse than the conventional six-month treatment regimen.
METHODS/DESIGN


S31/A5349 is a multicenter randomized controlled phase 3 non-inferiority trial that compares two four-month regimens with the standard six-month regimen for treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients. Both of the four-month regimens contain high-dose rifapentine instead of rifampin, with ethambutol replaced by moxifloxacin in one regimen. All drugs are administered seven days per week, and under direct observation at least five days per week. The primary outcome is tuberculosis disease-free survival at twelve months after study treatment assignment. A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of non-inferiority.
DISCUSSION


This phase 3 trial formally tests the hypothesis that augmentation of rifamycin exposures can shorten tuberculosis treatment to four months. Trial design and standardized implementation optimize the likelihood of obtaining valid results. Results of this trial may have important implications for clinical management of tuberculosis at both individual and programmatic levels.
TRIAL REGISTRATION


NCT02410772. Registered 8 April 2015,https://www.clinicaltrials.gov/ct2/show/NCT02410772?term=02410772&rank=1.",2020,A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of,"['pulmonary tuberculosis', '2500 participants', 'treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients']","['moxifloxacin', 'rifapentine with or without moxifloxacin']","['cure rates', 'tuberculosis disease-free survival']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}]","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",2500.0,0.389641,A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of,"[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Dorman', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA. Electronic address: dorman@musc.edu.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Nahid', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Ekaterina V', 'Initials': 'EV', 'LastName': 'Kurbatova', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Goldberg', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Bozeman', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, Denver, CO, USA.'}, {'ForeName': 'Kwok-Chiu', 'Initials': 'KC', 'LastName': 'Chang', 'Affiliation': 'Tuberculosis and Chest Service, Department of Health, Hong Kong.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cotton', 'Affiliation': 'Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Engle', 'Affiliation': 'Audie L. Murphy Veterans Affairs Medical Center / University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Pei-Jean', 'Initials': 'PJ', 'LastName': 'Feng', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Fletcher', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Phan', 'Initials': 'P', 'LastName': 'Ha', 'Affiliation': 'Vietnam National TB Program (NTP)/UCSF Research Collaboration, Hanoi, Viet Nam.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Heilig', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Lessem', 'Affiliation': 'Treatment Action Group, NY, New York, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Metchock', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Miro', 'Affiliation': 'Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nguyen Viet', 'Initials': 'NV', 'LastName': 'Nhung', 'Affiliation': 'Vietnam National TB Program (NTP)/UCSF Research Collaboration, Hanoi, Viet Nam.'}, {'ForeName': 'April C', 'Initials': 'AC', 'LastName': 'Pettit', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, USA.'}, {'ForeName': 'Patrick P J', 'Initials': 'PPJ', 'LastName': 'Phillips', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Podany', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Purfield', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA; U.S. Public Health Service Commissioned Corps, Rockville, MD, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Robergeau', 'Affiliation': 'Westat, Inc., Rockville, MD, USA.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Parirenyatwa Clinical Research Site, Harare, Zimbabwe.'}, {'ForeName': 'Nigel A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Sizemore', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vernon', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Weiner', 'Affiliation': 'Audie L. Murphy Veterans Affairs Medical Center / University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.105938']
3462,32020028,A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis.,"The PROteKT study tested the hypothesis that rosuvastatin can inhibit aminoglycoside-induced nephrotoxicity in children with Cystic Fibrosis (CF). This open label, parallel group, randomised controlled trial recruited children and young people aged 6 to 18 years with CF at 13 paediatric CF treatment centres in the UK. Participants were randomised equally to either receive oral rosuvastatin (10 mg once daily) or no intervention (control) throughout clinically indicated treatment with intravenous tobramycin. The primary outcome was the difference between the groups in mean fold-change in urinary Kidney Injury Molecule-1 (KIM-1). Fifty (rosuvastatin n = 23, control n = 27) participants were recruited between May 2015 and January 2017. Primary outcome data was available for 88% (rosuvastatin n = 20, control n = 24). The estimated mean treatment difference in the geometric mean-fold change of normalised KIM-1 was 1.08 (95% CI 0.87-1.35, p = 0.48). In total there were 12 adverse reactions, all mild, reported by five participants randomised to rosuvastatin, and one serious adverse event in each group. Whilst no protective effect of rosuvastatin was seen, there was a lower than expected level of nephrotoxicity in the cohort. Therefore, we can neither confirm nor refute the hypothesis that rosuvastatin protects against aminoglycoside nephrotoxicity.",2020,"Whilst no protective effect of rosuvastatin was seen, there was a lower than expected level of nephrotoxicity in the cohort.","['n\u2009=\u200923, control n\u2009', 'children with cystic fibrosis', 'children and young people aged 6 to 18 years with CF at 13 paediatric CF treatment centres in the UK', '27) participants were recruited between May 2015 and January 2017', 'children with Cystic Fibrosis (CF']","['Fifty (rosuvastatin', 'oral rosuvastatin (10\u2009mg once daily) or no intervention (control) throughout clinically indicated treatment with intravenous tobramycin', 'rosuvastatin']","['mean fold-change in urinary Kidney Injury Molecule-1 (KIM-1', 'level of nephrotoxicity', 'geometric mean-fold change of normalised KIM-1', 'kidney toxicity']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",27.0,0.106176,"Whilst no protective effect of rosuvastatin was seen, there was a lower than expected level of nephrotoxicity in the cohort.","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'McWilliam', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, Merseyside, United Kingdom. stevemcw@liv.ac.uk.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shaw', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greenhalf', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Department of Mathematics and Statistics, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rosalind L', 'Initials': 'RL', 'LastName': 'Smyth', 'Affiliation': 'University College London, Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, and MRC Centre for Drug Safety Science, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}]",Scientific reports,['10.1038/s41598-020-58790-1']
3463,31059641,Targeting Huntingtin Expression in Patients with Huntington's Disease.,"BACKGROUND


Huntington's disease is an autosomal-dominant neurodegenerative disease caused by CAG trinucleotide repeat expansion in  HTT , resulting in a mutant huntingtin protein. IONIS-HTT Rx  (hereafter, HTT Rx ) is an antisense oligonucleotide designed to inhibit  HTT  messenger RNA and thereby reduce concentrations of mutant huntingtin.
METHODS


We conducted a randomized, double-blind, multiple-ascending-dose, phase 1-2a trial involving adults with early Huntington's disease. Patients were randomly assigned in a 3:1 ratio to receive HTT Rx  or placebo as a bolus intrathecal administration every 4 weeks for four doses. Dose selection was guided by a preclinical model in mice and nonhuman primates that related dose level to reduction in the concentration of huntingtin. The primary end point was safety. The secondary end point was HTT Rx  pharmacokinetics in cerebrospinal fluid (CSF). Prespecified exploratory end points included the concentration of mutant huntingtin in CSF.
RESULTS


Of the 46 patients who were enrolled in the trial, 34 were randomly assigned to receive HTT Rx  (at ascending dose levels of 10 to 120 mg) and 12 were randomly assigned to receive placebo. Each patient received all four doses and completed the trial. Adverse events, all of grade 1 or 2, were reported in 98% of the patients. No serious adverse events were seen in HTT Rx -treated patients. There were no clinically relevant adverse changes in laboratory variables. Predose (trough) concentrations of HTT Rx  in CSF showed dose dependence up to doses of 60 mg. HTT Rx  treatment resulted in a dose-dependent reduction in the concentration of mutant huntingtin in CSF (mean percentage change from baseline, 10% in the placebo group and -20%, -25%, -28%, -42%, and -38% in the HTT Rx  10-mg, 30-mg, 60-mg, 90-mg, and 120-mg dose groups, respectively).
CONCLUSIONS


Intrathecal administration of HTT Rx  to patients with early Huntington's disease was not accompanied by serious adverse events. We observed dose-dependent reductions in concentrations of mutant huntingtin. (Funded by Ionis Pharmaceuticals and F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT02519036.).",2019,"HTT Rx  treatment resulted in a dose-dependent reduction in the concentration of mutant huntingtin in CSF (mean percentage change from baseline, 10% in the placebo group and -20%, -25%, -28%, -42%, and -38% in the HTT Rx  10-mg, 30-mg, 60-mg, 90-mg, and 120-mg dose groups, respectively).
","[""Patients with Huntington's Disease"", ""adults with early Huntington's disease"", '46 patients who were enrolled in the trial']","['HTT Rx  or placebo', 'placebo', 'HTT Rx']","['Adverse events', 'HTT Rx  pharmacokinetics in cerebrospinal fluid (CSF', 'concentration of mutant huntingtin in CSF', 'serious adverse events', 'concentrations of mutant huntingtin', 'Predose (trough) concentrations of HTT Rx']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020179', 'cui_str': 'Progressive Chorea, Hereditary, Chronic (Huntington)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007807'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",34.0,0.262503,"HTT Rx  treatment resulted in a dose-dependent reduction in the concentration of mutant huntingtin in CSF (mean percentage change from baseline, 10% in the placebo group and -20%, -25%, -28%, -42%, and -38% in the HTT Rx  10-mg, 30-mg, 60-mg, 90-mg, and 120-mg dose groups, respectively).
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Tabrizi', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Blair R', 'Initials': 'BR', 'LastName': 'Leavitt', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'G Bernhard', 'Initials': 'GB', 'LastName': 'Landwehrmeyer', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Wild', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Saft', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Barker', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Nick F', 'Initials': 'NF', 'LastName': 'Blair', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Craufurd', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Priller', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Rickards', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rosser', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Holly B', 'Initials': 'HB', 'LastName': 'Kordasiewicz', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Czech', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Swayze', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Norris', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Baumann', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gerlach', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Schobel', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Paz', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Smith', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'C Frank', 'Initials': 'CF', 'LastName': 'Bennett', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Roger M', 'Initials': 'RM', 'LastName': 'Lane', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900907']
3464,32070409,"A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan.","BACKGROUND


The total ankle replacement versus ankle arthrodesis (TARVA) trial aims to determine which surgical procedure confers the greatest improvement in pain-free function for patients with end-stage ankle osteoarthritis. Both procedures are effective but there has not yet been a direct comparison to establish which is superior. This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written prior to the end of patient follow-up, while the outcome of the trial is still unknown.
DESIGN AND METHODS


TARVA is a randomised, un-blinded, parallel group trial of total ankle replacement versus ankle arthrodesis. The primary outcome is the Manchester-Oxford Foot Questionnaire walking/standing domain score at 52 weeks post-surgery. Secondary outcomes include measures of pain, social interaction, physical function, quality of life, and range of motion. We describe in detail the statistical aspects of TARVA: the outcome measures, the sample size calculation, general analysis principles including treatment of missing data, the planned descriptive statistics and statistical models, and planned subgroup and sensitivity analyses.
DISCUSSION


The TARVA statistical analysis will provide comprehensive and precise information on the relative effectiveness of the two treatments. The plan will be implemented in January 2020 when follow-up for the trial is completed.
TRIAL REGISTRATION


ISRCTN registry number 60672307, ClinicalTrials.gov registration number NCT02128555. Registered 1 May 2014. Recruitment started in January 2015 and ended in January 2019.",2020,The TARVA statistical analysis will provide comprehensive and precise information on the relative effectiveness of the two treatments.,"['patients with end-stage ankle osteoarthritis', 'patients with end stage ankle osteoarthritis (TARVA']","['total ankle replacement versus ankle arthrodesis', 'total ankle replacement versus ankle arthrodesis (TARVA', 'TARVA']","['Manchester-Oxford Foot Questionnaire walking/standing domain score', 'measures of pain, social interaction, physical function, quality of life, and range of motion', 'pain-free function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0409931', 'cui_str': 'Osteoarthritis of ankle (disorder)'}]","[{'cui': 'C0188664', 'cui_str': 'Arthroplasty, Replacement, Ankle'}, {'cui': 'C0188661', 'cui_str': 'Arthrodesis of ankle (procedure)'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",,0.183547,The TARVA statistical analysis will provide comprehensive and precise information on the relative effectiveness of the two treatments.,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Muller', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK. p.muller@ucl.ac.uk.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Department of Clinical and Experimental Medicine, School of Biosciences and Medicine, University of Surrey, Guildford, Surrey, UK.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Cro', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Goldberg', 'Affiliation': 'UCL Institute of Orthopaedics and Musculoskeletal Science (IOMS), Royal National Orthopaedic Hospital (RNOH), London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3973-4']
3465,32092060,Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines.,"BACKGROUND


HVTN 100 evaluated the safety and immunogenicity of an HIV subtype C pox-protein vaccine regimen, investigating a 12-month booster to extend vaccine-induced immune responses.
METHODS AND FINDINGS


A phase 1-2 randomized double-blind placebo-controlled trial enrolled 252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015. Vaccine recipients received ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59 at months 3, 6, and 12. Antibody (IgG, IgG3 binding, and neutralizing) and CD4+ T-cell (expressing interferon-gamma, interleukin-2, and CD40 ligand) responses were evaluated at month 6.5 for all participants and at months 12, 12.5, and 18 for a randomly selected subset. The primary analysis compared IgG binding antibody (bAb) responses and CD4+ T-cell responses to 3 vaccine-matched antigens at peak (month 6.5 versus 12.5) and durability (month 12 versus 18) timepoints; IgG responses to CaseA2_gp70_V1V2.B, a primary correlate of risk in RV144, were also compared at these same timepoints. Secondary and exploratory analyses compared IgG3 bAb responses, IgG bAb breadth scores, neutralizing antibody (nAb) responses, antibody-dependent cellular phagocytosis, CD4+ polyfunctionality responses, and CD4+ memory sub-population responses at the same timepoints. Vaccines were generally safe and well tolerated. During the study, there were 2 deaths (both in the vaccine group and both unrelated to study products). Ten participants became HIV-infected during the trial, 7% (3/42) of placebo recipients and 3% (7/210) of vaccine recipients. All 8 serious adverse events were unrelated to study products. Less waning of immune responses was seen after the fifth vaccination than after the fourth, with higher antibody and cellular response rates at month 18 than at month 12: IgG bAb response rates to 1086.C V1V2, 21.0% versus 9.7% (difference = 11.3%, 95% CI = 0.6%-22.0%, P = 0.039), and ZM96.C V1V2, 21.0% versus 6.5% (difference = 14.5%, 95% CI = 4.1%-24.9%, P = 0.004). IgG bAb response rates to all 4 primary V1V2 antigens were higher 2 weeks after the fifth vaccination than 2 weeks after the fourth vaccination: 87.7% versus 75.4% (difference = 12.3%, 95% CI = 1.7%-22.9%, P = 0.022) for 1086.C V1V2, 86.0% versus 63.2% (difference = 22.8%, 95% CI = 9.1%-36.5%, P = 0.001) for TV1c8.2.C V1V2, 67.7% versus 44.6% (difference = 23.1%, 95% CI = 10.4%-35.7%, P < 0.001) for ZM96.C V1V2, and 81.5% versus 60.0% (difference = 21.5%, 95% CI = 7.6%-35.5%, P = 0.002) for CaseA2_gp70_V1V2.B. IgG bAb response rates to the 3 primary vaccine-matched gp120 antigens were all above 90% at both peak timepoints, with no significant differences seen, except a higher response rate to ZM96.C gp120 at month 18 versus month 12: 64.5% versus 1.6% (difference = 62.9%, 95% CI = 49.3%-76.5%, P < 0.001). CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints. Limitations were that higher doses of gp120 were not evaluated, this study was not designed to investigate HIV prevention efficacy, and the clinical significance of the observed immunological effects is uncertain.
CONCLUSIONS


In this study, a 12-month booster of subtype C pox-protein vaccines restored immune responses, and slowed response decay compared to the 6-month vaccination.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02404311. South African National Clinical Trials Registry (SANCTR number: DOH--27-0215-4796).",2020,"CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints.","['252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015', 'healthy HIV-uninfected adults in HVTN 100 in South Africa']","['placebo', 'ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59', 'expressing interferon-gamma, interleukin-2, and CD40 ligand', 'ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines']","['safe and well tolerated', 'cellular response rates', 'CD4+ T-cell response rates', 'IgG binding antibody (bAb) responses and CD4+ T-cell responses', 'IgG bAb response rates', 'HIV prevention efficacy', 'durability', 'Antibody (IgG, IgG3 binding, and neutralizing) and CD4+ T-cell ', 'Safety and immune responses', 'IgG3 bAb responses, IgG bAb breadth scores, neutralizing antibody (nAb) responses, antibody-dependent cellular phagocytosis, CD4+ polyfunctionality responses, and CD4+ memory sub-population responses']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0019691', 'cui_str': 'Envelope Glycoprotein gp120, HIV'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0167627', 'cui_str': 'T-B Cell Activating Molecule'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",252.0,0.458219,"CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints.","[{'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Soshanguve, South Africa.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mngadi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Brodie', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp Research Centre, Klerksdorp, South Africa.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Saunders', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK Vaccines, Rixensart, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van Der Meeren', 'Affiliation': 'GSK Vaccines, Rixensart, Belgium.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bentley', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pensiero', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Vijay L', 'Initials': 'VL', 'LastName': 'Mehra', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003038']
3466,30978556,"Rationale and design of the randomized, controlled Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis (EVOLVED) trial.","BACKGROUND


The optimal timing of aortic valve replacement in asymptomatic patients with aortic stenosis is uncertain. Replacement fibrosis, as assessed by midwall (nonischemic) late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) imaging, is an irreversible marker of left ventricular decompensation in aortic stenosis. Once established, it progresses rapidly and is associated with poor long-term prognosis in a dose-dependent manner.
TRIAL DESIGN


The objective of this multicenter prospective randomized controlled trial is to determine whether early aortic valve replacement in asymptomatic patients with severe aortic stenosis can improve the adverse prognosis associated with midwall LGE. Patients will be screened for likelihood of having LGE with electrocardiography or high-sensitivity troponin I. Those at high risk will proceed to CMR imaging. Approximately 400 patients with midwall LGE will be randomized 1:1 to early valve replacement or routine care. Those who do not exhibit midwall LGE will continue with routine care and be randomized to a study registry or no further follow-up. Follow-up will be annual for approximately 3 years until the number of required outcome events is achieved. The primary endpoint is a composite of all-cause mortality and unplanned aortic stenosis-related hospitalization. The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level. Key secondary endpoints include all-cause mortality, sudden cardiac death, stroke, and symptomatic status.
CONCLUSION


The EVOLVED trial is the first multicenter randomized controlled trial to compare early aortic valve replacement to routine care in asymptomatic patients with severe aortic stenosis and midwall LGE.",2019,The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level.,"['asymptomatic patients with severe aortic stenosis', 'aortic stenosis', 'asymptomatic patients with aortic stenosis', 'Patients will be screened for likelihood of having LGE with electrocardiography or high-sensitivity troponin I', 'Asymptomatic Patients with Severe Aortic Stenosis (EVOLVED) trial', 'asymptomatic patients with severe aortic stenosis and midwall LGE', 'Approximately 400 patients with midwall LGE']","['early aortic valve replacement', 'early valve replacement or routine care', 'aortic valve replacement']","['cause mortality, sudden cardiac death, stroke, and symptomatic status', 'composite of all-cause mortality and unplanned aortic stenosis-related hospitalization', 'event rate']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",400.0,0.140741,The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Everett', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tuck', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Steff', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Harkess', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Treibel', 'Affiliation': 'Barts Health NHS Trust and University College London, London, United Kingdom.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Imperial College London and Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, and the NIHR Leicester Biomedical Research Centre, Leicester, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: Marc.dweck@ed.ac.uk.'}]",American heart journal,['10.1016/j.ahj.2019.02.018']
3467,31311922,A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery.,"Iatrogenic injury of the ureters is a feared complication of abdominal surgery. Zwitterionic near-infrared fluorophores are molecules with geometrically-balanced, electrically-neutral surface charge, which leads to renal-exclusive clearance and ultralow non-specific background binding. Such molecules could solve the ureter mapping problem by providing real-time anatomic and functional imaging, even through intact peritoneum. Here we present the first-in-human experience of this chemical class, as well as the efficacy study in patients undergoing laparoscopic abdominopelvic surgery. The zwitterionic near-infrared fluorophore ZW800-1 is safe, has pharmacokinetic properties consistent with an ideal blood pool agent, and rapid elimination into urine after a single low-dose intravenous injection. Visualization of structure and function of the ureters starts within minutes after ZW800-1 injection and lasts several hours. Zwitterionic near-infrared fluorophores add value during laparoscopic abdominopelvic surgeries and could potentially decrease iatrogenic urethral injury. Moreover, ZW800-1 is engineered for one-step covalent conjugatability, creating possibilities for developing novel targeted ligands.",2019,Visualization of structure and function of the ureters starts within minutes after ZW800-1 injection and lasts several hours.,['patients undergoing laparoscopic abdominopelvic surgery'],[],['iatrogenic urethral injury'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C0439669', 'cui_str': 'Iatrogenic (qualifier value)'}, {'cui': 'C0403701', 'cui_str': 'Injury of urethra (disorder)'}]",,0.059943,Visualization of structure and function of the ureters starts within minutes after ZW800-1 injection and lasts several hours.,"[{'ForeName': 'Kim S', 'Initials': 'KS', 'LastName': 'de Valk', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands. k.s.de_valk@lumc.nl.'}, {'ForeName': 'Henricus J', 'Initials': 'HJ', 'LastName': 'Handgraaf', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Deken', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Babs G', 'Initials': 'BG', 'LastName': 'Sibinga Mulder', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Adrianus R', 'Initials': 'AR', 'LastName': 'Valentijn', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Anton G', 'Initials': 'AG', 'LastName': 'Terwisscha van Scheltinga', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Joeri', 'Initials': 'J', 'LastName': 'Kuil', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'van Esdonk', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Vuijk', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Rob F', 'Initials': 'RF', 'LastName': 'Bevers', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Koen C', 'Initials': 'KC', 'LastName': 'Peeters', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Fabian A', 'Initials': 'FA', 'LastName': 'Holman', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Frangioni', 'Affiliation': 'Curadel, LLC, Marlborough, MA, USA.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Vahrmeijer', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}]",Nature communications,['10.1038/s41467-019-11014-1']
3468,32108545,Interrater Reliability of Dynamic Muscle Testing After Breast Cancer Surgery in Women at High Risk of Lymphedema: To Improve Quality in Clinical Practice.,"Background:  The purpose of this study is to determine the interrater reliability of dynamic muscle tests in the early rehabilitation phase in women after breast cancer surgery with axillary lymph node dissection (ALND) based on the ""preventive intervention against lymphedema after breast cancer"" (LYCA) randomised controlled trial.  Methods:  Fifteen women treated with breast cancer surgery including ALND were recruited from participants in the LYCA trial. In this interrater reliability study, women were tested in 4 dynamic muscle tests by 2 physiotherapists at a Capital Hospital in Denmark. Intraclass correlation coefficients (ICCs) with 95% confidence intervals (CIs) was used to assess the relative reliability between raters. A Bland-Altman plot and limits of agreement were calculated to describe the absolute reliability.  Results:  All 6 subtests displayed high interrater reliability. ICC values were: leg press 0.96 (95% CI = 0.87-0.99), elbow flexion (contralateral) 0.94 (0.83-0.98), elbow flexion (affected arm) 0.93 (0.80-0.98), elbow extension 0.80 (0.41-0.93), shoulder abduction (contralateral) 0.89 (0.68-0.96), and shoulder abduction (affected arm) 0.91 (0.74-0.97). Cumulated interrater reliability for the test battery was very high (ICC = 0.99, 95% CI = 0.990-1.0). The absolute reliability of this study was considered high, and the absence of large shifts between mean and the line of 0 difference suggest no systematic bias that could influence clinical interpretation.  Conclusions:  The dynamic muscle tests evaluated in this study had high interrater reliability and can be used reliably in women in the postoperative phase after breast cancer surgery with ALND.",2020,"ICC values were: leg press 0.96 (95% CI = 0.87-0.99), elbow flexion (contralateral) 0.94 (0.83-0.98), elbow flexion (affected arm) 0.93 (0.80-0.98), elbow extension 0.80 (0.41-0.93), shoulder abduction (contralateral) 0.89 (0.68-0.96), and shoulder abduction (affected arm)","['women after breast cancer surgery with axillary lymph node dissection (ALND) based on the ""preventive intervention against lymphedema after breast cancer"" (LYCA', 'women in the postoperative phase after breast cancer surgery with ALND', 'Fifteen women treated with breast cancer surgery including ALND were recruited from participants in the LYCA trial', 'Women at High Risk of Lymphedema', 'women were tested in 4 dynamic muscle tests by 2 physiotherapists at a Capital Hospital in Denmark']",['Dynamic Muscle Testing'],"['shoulder abduction', 'Intraclass correlation coefficients (ICCs', 'Cumulated interrater reliability', 'elbow flexion', 'ICC values']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0905105,"ICC values were: leg press 0.96 (95% CI = 0.87-0.99), elbow flexion (contralateral) 0.94 (0.83-0.98), elbow flexion (affected arm) 0.93 (0.80-0.98), elbow extension 0.80 (0.41-0.93), shoulder abduction (contralateral) 0.89 (0.68-0.96), and shoulder abduction (affected arm)","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Korsholm-Rosfort', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, University College Copenhagen, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Larsen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, University College Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aagaard', 'Affiliation': 'Department of Physio- and Occupational Therapy, Holbaek Hospital, Denmark.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Ammitzbøll', 'Affiliation': 'Danish Research Center for Equality in Cancer (COMPAS), Zealand University Hospital, Naestved, Denmark.'}, {'ForeName': 'Susanne O', 'Initials': 'SO', 'LastName': 'Dalton', 'Affiliation': 'Danish Research Center for Equality in Cancer (COMPAS), Zealand University Hospital, Naestved, Denmark.'}]",Integrative cancer therapies,['10.1177/1534735420903801']
3469,30422390,"A Randomized, Placebo-Controlled, Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Soluble Guanylate Cyclase Stimulator Praliciguat in Healthy Subjects.","Nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) signaling is central to the regulation of several physiological processes, including blood flow and inflammation. Deficient NO signaling is implicated in multiple diseases. sGC stimulators are small molecules that enhance sGC activity, particularly in combination with NO. In a randomized, placebo-controlled phase 1 study, the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of the sGC stimulator praliciguat were assessed in 44 healthy adults. Four cohorts of 11 subjects (8 praliciguat, 3 placebo) received once-daily praliciguat for 14 days before up-titrating for 7 days (treatment sequences: 15/30 mg, 20/40 mg, 30/40 mg, and weight-based). All doses were tolerated. No serious or severe adverse events (AEs) were reported. The most common AEs in praliciguat recipients were headache and symptoms consistent with blood pressure (BP) lowering/vasodilation. There were no laboratory, vital sign, electrocardiographic, or platelet function findings indicative of a safety concern. Pharmacokinetics were dose proportional, with an effective half-life of 24-37 hours, supporting once-daily dosing. Praliciguat produced dose-related increases in plasma cGMP consistent with stimulation of sGC. Repeated once-daily dosing showed sustained decreases in BP. Results support evaluation of praliciguat for the treatment of conditions associated with deficient NO signaling.",2019,"Pharmacokinetics were dose proportional, with an effective half-life of 24-37 hours, supporting once-daily dosing.","['Healthy Subjects', '44\xa0healthy adults']","['Nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP', 'Placebo', 'sGC', 'placebo']","['No serious or severe adverse events (AEs', 'tolerated', 'headache and symptoms consistent with blood pressure (BP) lowering/vasodilation', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'BP', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'plasma cGMP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1097411', 'cui_str': 'Soluble Guanylate Cyclase'}, {'cui': 'C0018338', 'cui_str': ""Guanosine Cyclic 3',5'-Monophosphate""}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.112738,"Pharmacokinetics were dose proportional, with an effective half-life of 24-37 hours, supporting once-daily dosing.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Hanrahan', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Wakefield', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'Phebe J', 'Initials': 'PJ', 'LastName': 'Wilson', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mihova', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Chickering', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Ruff', 'Affiliation': 'ICON Early Phase Services LLC, San Antonio, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'G Todd', 'Initials': 'GT', 'LastName': 'Milne', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Currie', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Profy', 'Affiliation': 'Ironwood Pharmaceuticals Inc., Cambridge, MA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.627']
3470,31412902,"Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial.","BACKGROUND


Growing evidence suggests that experiences in the early years play a major role in children's development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children's life trajectories.
METHODS


THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant.
DISCUSSION


The population we aim to recruit are traditionally referred to as ""hard to reach"", therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments.
TRIAL REGISTRATION


International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568 . Registered on 28 February 2014 (registered retrospectively (by 3 months)).",2019,"Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual.","['500 pregnant women with additional health or social care needs', 'Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy', 'Participants will be referred by health and social care professionals, predominately midwives']","['Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual']",['maternal mental health and parenting skills'],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",500.0,0.227388,"Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual.","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Henderson', 'Affiliation': 'Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland. Marion.Henderson@glasgow.ac.uk.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Wittkowski', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, The University of Manchester, 2nd Floor Zochonis Building, Brunswick Street, Manchester, M13 9PL, England.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, G12 8QQ, Scotland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Boyd Orr Building, University of Glasgow, Glasgow, G12 8QQ, Scotland.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Buston', 'Affiliation': 'Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Centre for Rural Health, University of Aberdeen, The Centre for Health Science, Old Perth Road, Inverness, IV2 3JH, Scotland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Calam', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, The University of Manchester, 2nd Floor Zochonis Building, Brunswick Street, Manchester, M13 9PL, England.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Minnis', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Caledonia House, Royal Hospital for Sick Children, Yorkhill, Glasgow, G3 8SJ, Scotland.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Thompson', 'Affiliation': 'Centre for Rural Health, University of Aberdeen, The Centre for Health Science, Old Perth Road, Inverness, IV2 3JH, Scotland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Dowd"", 'Affiliation': 'NHS Ayrshire and Arran, Afton House, Ailsa Hospital Campus, Dalmellington Road, Ayr, KA6 6AB, Scotland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Law', 'Affiliation': 'Institute of Health and Society, School of Education, Communication and Language Sciences, University of Newcastle, Newcastle-upon-Tyne, NE1 7RU, England.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McGee', 'Affiliation': 'Parenting and Family Support Research Programme, Department of Psychology and Allied Health Sciences, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, Scotland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wight', 'Affiliation': 'Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3571-5']
3471,32128938,"Illness uncertainty, coping, and quality of life among patients with prostate cancer.","OBJECTIVE


Illness uncertainty is a significant source of psychological distress that affects cancer patients' quality of life (QOL). Mishel's uncertainty in illness theory (UIT) proposes that illness uncertainty influences an individual's use of coping strategies, and directly and indirectly influences their QOL. This study tested the relationships depicted in the adapted UIT in cancer patients.
METHODS


This cross-sectional study is a secondary analysis of the baseline data from a randomized clinical trial (N = 263 prostate cancer patients). Patients were diagnosed with localized (64.6%), biochemical recurrent (12.6%), or advanced (22.8%) prostate cancer. Uncertainty, coping (avoidant and active coping strategies), and QOL (physical and mental well-being) were measured using the Mishel's uncertainty of illness scale, Brief COPE, and the Medical Outcomes Study 12-item short form (SF-12), respectively. We used path analysis to achieve the research aim.
RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05). Patients' illness uncertainty was positively related to their avoidant coping strategies (P < .001). Patients' active and avoidant coping strategies influenced their mental well-being (P < .001). Uncertainty also negatively influenced mental well-being through avoidant coping strategies. The model had excellent fit to the data.
CONCLUSIONS


Our findings have indicated the potential of improving QOL by decreasing illness uncertainty and reducing avoidant coping strategies. Future research is needed to better understand the complex relationships between illness uncertainty, coping strategies, and domains of QOL among patients with different types of cancer using longitudinal research.",2020,"RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05).","['patients with prostate cancer', 'Patients were diagnosed with localized (64.6%), biochemical recurrent (12.6%), or advanced (22.8%) prostate cancer', 'cancer patients', '263 prostate cancer patients']",[],"['Uncertainty, coping (avoidant and active coping strategies), and QOL (physical and mental well-being', 'Illness uncertainty, coping, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517671', 'cui_str': '263'}]",[],"[{'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0034380'}]",263.0,0.0364443,"RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05).","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sheila Judge', 'Initials': 'SJ', 'LastName': 'Santacroce', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ding-Geng', 'Initials': 'DG', 'LastName': 'Chen', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Psycho-oncology,['10.1002/pon.5372']
3472,32128909,Cancer worry and empathy moderate the effect of a survivorship-focused intervention on quality of life.,"OBJECTIVE


This study examined the impact of a survivorship planning consultation (SPC) for patients with Hodgkin's lymphoma and diffuses large B-cell lymphoma on quality of life (QOL). We specifically assessed two potential moderators, cancer worry and perceived empathy, of the intervention effects on QOL.
METHODS


This cluster randomized, four-site trial examined the efficacy of a SPC; physicians received communication skills training and applied these skills in a survivorship-focused office visit using a care plan vs a control arm in which physicians were trained to and subsequently provided a time-controlled, manualized wellness rehabilitation consultation focused only on discussion of healthy nutrition and exercise. We examined the effect of the intervention on patients' QOL and examined potential moderators-cancer worry and perceived physician empathy.
RESULTS


Forty-two physicians and 198 patients participated. There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10). However, cancer worry was a significant moderator of the effects of the intervention on three QOL domains (physical P = .04; social P = .04; spiritual P = .01) and perceived empathy was a significant moderator of QOL (physical P = .004; psychological P = .04; social P = .01). Specifically, the beneficial effects of the intervention were more pronounced among patients who initially reported higher levels of cancer worry and lower levels of physician empathy.
CONCLUSIONS


This study identified two factors, perceived empathy and cancer worry, that were found to impact the QOL of patients who participated in this communication-based survivorship intervention.",2020,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"['Forty-two physicians and 198 patients participated', ""patients with Hodgkin's lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL"", 'patients who participated in this communication-based survivorship intervention']","['manualized Wellness Rehabilitation Consultation (WRC) focused only on discussion of healthy nutrition and exercise', 'survivorship planning consultation (SPC', 'communication skills training']","['QOL dimensions', 'quality of life', 'cancer worry and lower levels of physician empathy', 'quality of life (QOL']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038955'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038955'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",198.0,0.0188331,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Smita C', 'Initials': 'SC', 'LastName': 'Banerjee', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Carma L', 'Initials': 'CL', 'LastName': 'Bylund', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Cancer Control & Population Sciences, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Astrow', 'Affiliation': 'Department of Medicine, New York Methodist Hospital, Hematology and Oncology, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Leventhal', 'Affiliation': 'Department of Psychology, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kissane', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}]",Psycho-oncology,['10.1002/pon.5371']
3473,32021697,Cost-effectiveness and value of information analysis of a low-friction environment following skin graft in patients with burn injury.,"Background


Patients with burn injuries may receive a skin graft to achieve healing in a timely manner. However, in around 7% of cases, the skin graft is lost (fails to attach to the wound site) and a re-grafting procedure is necessary. It has been hypothesised that low-friction (smooth, more slippery) bedding may reduce the risk of skin-graft loss. A before and after feasibility study comparing low-friction with standard bedding in skin-grafted patients was conducted in order to collect proof of concept data. The resulting relative risk on the primary outcome (number of patients with skin graft failure) for the non-randomised study provided no evidence of effect but had a large standard error. The aim of this study is to see if an appropriately powered randomised control trial would be worthwhile.
Methods


A probabilistic decision-analytic model was constructed to compare low-friction bedding to standard care in a population of burn patients who have undergone skin grafting. Results from the before and after study were used as model inputs. The sensitivity of results to bias in the relative risk of graft loss was conducted. Low-friction bedding is considered optimal if expected incremental net benefit (INB) is positive. Uncertainty is assessed using cost-effectiveness acceptability curves. Expected Value of Perfect Partial Information (EVPPI) provides an upper bound for the potential net health benefits of new research for given model input.
Results


At a willingness to pay threshold of £20,000 per QALY, INB = £151 (95% Credible Interval (CrI) -142 to 814), marginally favouring low-friction bedding but with high uncertainty (probability of being cost-effective 70.5%). Expected value of perfect information (EVPI) per patient was £20.29, which results in a population EVPI of £174,765 over a 10-year lifetime for the technology (based on 1000 patients per year who would benefit from the intervention). The parameter contributing most to the uncertainty was the inpatient care cost, i.e. information that could be obtained from the audit of practice and without an expensive trial. These findings were robust to a wide-range of assumptions about the potential bias due to the observational nature of the comparative evidence.
Conclusions


Our study results suggest that an RCT (randomised controlled trial) is unlikely to be worthwhile, but there may be value in a study to estimate the re-graft rates and associated costs in this population.",2020,The resulting relative risk on the primary outcome (number of patients with skin graft failure) for the non-randomised study provided no evidence of effect but had a large standard error.,"['skin-grafted patients', 'burn patients who have undergone skin grafting', 'patients with burn injury']","['low-friction environment', 'RCT', 'skin graft']",[],"[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0556839', 'cui_str': 'Physiotherapeutic frictions'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}]",[],,0.151965,The resulting relative risk on the primary outcome (number of patients with skin graft failure) for the non-randomised study provided no evidence of effect but had a large standard error.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': '1Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Thom', 'Affiliation': '1Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Young', 'Affiliation': '1Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Greenwood', 'Affiliation': '2University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Nicky J', 'Initials': 'NJ', 'LastName': 'Welton', 'Affiliation': '1Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-019-0543-1']
3474,30544237,Remote ischaemic preconditioning in isolated aortic valve and coronary artery bypass surgery: a randomized trial†.,"OBJECTIVES


This trial was designed and patients were recruited at a time when the benefits of remote ischaemic preconditioning during open-heart surgery were still controversial. We focused on a homogeneous patient population undergoing either isolated aortic valve replacement or coronary artery bypass grafting (CABG) surgery by investigating cardiac injury, metabolic stress and inflammatory response.
METHODS


A 2-centre randomized controlled trial recruited a total of 124 patients between February 2013 and April 2015. Of them, 64 patients underwent CABG and 60 patients underwent aortic valve replacement. Patients were randomized to either sham or preconditioning. Remote ischaemic preconditioning was applied following anaesthesia and before sternotomy. Myocardial injury and inflammatory response were assessed by serially measuring cardiac troponin I, and interleukin-6, 8, 10 and the tumour necrosis factor (TNF-α). Biopsies from the left and the right ventricles were harvested after ischaemic reperfusion injury for nucleotides analysis.
RESULTS


Application of remote ischaemic preconditioning did not alter the degree of troponin I release, levels of inflammatory markers and cardiac energetics in both the CABG and the aortic valve replacement groups.
CONCLUSIONS


Preconditioning did not confer any additional cardioprotection in terms of reducing the levels of troponin I and inflammatory markers and preserving left and right ventricle energy metabolites in patients undergoing isolated CABG or aortic valve surgery.
CLINICAL TRIAL REGISTRATION NUMBER


International Standard Randomized Controlled Trial Number (ISRCTN) registry ID 33084113 (doi: 10.1186/ISRCTN33084113) and UK controlled randomized trial number (UKCRN) registry ID 13672.",2019,"CONCLUSIONS


Preconditioning did not confer any additional cardioprotection in terms of reducing the levels of troponin I and inflammatory markers and preserving left and right ventricle energy metabolites in patients undergoing isolated CABG or aortic valve surgery.
","['isolated aortic valve and coronary artery bypass surgery', 'homogeneous patient population undergoing either', '124 patients between February 2013 and April 2015', '64 patients underwent', 'patients undergoing isolated CABG or aortic valve surgery']","['sham or preconditioning', 'isolated aortic valve replacement or coronary artery bypass grafting (CABG) surgery', 'remote ischaemic preconditioning during open-heart surgery', 'CABG', 'Remote ischaemic preconditioning', 'aortic valve replacement']","['cardiac troponin', 'Myocardial injury and inflammatory response', 'levels of troponin I and inflammatory markers and preserving left and right ventricle energy metabolites', 'degree of troponin I release, levels of inflammatory markers and cardiac energetics', 'NUMBER']","[{'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}]","[{'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0225883', 'cui_str': 'Right Ventricle'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",124.0,0.177655,"CONCLUSIONS


Preconditioning did not confer any additional cardioprotection in terms of reducing the levels of troponin I and inflammatory markers and preserving left and right ventricle energy metabolites in patients undergoing isolated CABG or aortic valve surgery.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moscarelli', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, The Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Imperial College, National Heart and Lung Institute, London, UK.'}, {'ForeName': 'M-Saadeh', 'Initials': 'MS', 'LastName': 'Suleiman', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, The Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Emanueli', 'Affiliation': 'Imperial College, National Heart and Lung Institute, London, UK.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, The Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Prakash P', 'Initials': 'PP', 'LastName': 'Punjabi', 'Affiliation': 'Imperial College, National Heart and Lung Institute, London, UK.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, The Bristol Medical School, University of Bristol, Bristol, UK.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezy404']
3475,31874891,"Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol.","INTRODUCTION


A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.
METHODS AND ANALYSIS


A three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1)  incentivised-peer-networks:  peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2)  peer-navigator-distribution:  peer-navigators distribute HIVST packs and information directly to young people; (3)  standard of care:  peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990-1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03751826; Pre-results.",2019,"A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.
","['Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months', 'young women in rural KwaZulu-Natal, South Africa', 'young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa']","['HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks', 'peer delivery HIV self-testing to support linkage to HIV prevention', 'peer-navigator for additional HIVST packs to distribute; (2)  peer-navigator-distribution', ""incentivised-peer-networks:  peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks"", 'antiretroviral therapy and pre-exposure prophylaxis (PrEP']","['linkage rate', 'peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",24.0,0.104928,"A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.
","[{'ForeName': 'Oluwafemi Atanda', 'Initials': 'OA', 'LastName': 'Adeagbo', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Nondumiso', 'Initials': 'N', 'LastName': 'Mthiyane', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mee', 'Affiliation': 'Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Neuman', 'Affiliation': 'Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Dreyer', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Natsayi', 'Initials': 'N', 'LastName': 'Chimbindi', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Smit', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Okesola', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Harare, Zimbabwe.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Cowan', 'Affiliation': 'International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Corbett', 'Affiliation': 'Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa m.shahmanesh@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033435']
3476,31143445,Effects on body composition and handgrip strength of a nutritional intervention for malnourished HIV-infected adults referred for antiretroviral therapy: a randomised controlled trial.,"Lipid-based nutrient supplements (LNS) may be beneficial for malnourished HIV-infected patients starting antiretroviral therapy (ART). We assessed the effect of adding vitamins and minerals to LNS on body composition and handgrip strength during ART initiation. ART-eligible HIV-infected patients with BMI <18·5 kg/m 2  were randomised to LNS or LNS with added high-dose vitamins and minerals (LNS-VM) from referral for ART to 6 weeks post-ART and followed up until 12 weeks. Body composition by bioelectrical impedance analysis (BIA), deuterium ( 2 H) diluted water (D 2 O) and air displacement plethysmography (ADP), and handgrip strength were determined at baseline and at 6 and 12 weeks post-ART, and effects of LNS-VM  v.  LNS at 6 and 12 weeks investigated. BIA data were available for 1461, D 2 O data for 479, ADP data for 498 and handgrip strength data for 1752 patients. Fat mass tended to be lower, and fat-free mass correspondingly higher, by BIA than by ADP or D 2 O. At 6 weeks post-ART, LNS-VM led to a higher regain of BIA-assessed fat mass (0·4 (95 % CI 0·05, 0·8) kg), but not fat-free mass, and a borderline significant increase in handgrip strength (0·72 (95 % CI -0·03, 1·5) kg). These effects were not sustained at 12 weeks. Similar effects as for BIA were seen using ADP or D 2 O but no differences reached statistical significance. In conclusion, LNS-VM led to a higher regain of fat mass at 6 weeks and to a borderline significant beneficial effect on handgrip strength. Further research is needed to determine appropriate timing and supplement composition to optimise nutritional interventions in malnourished HIV patients.",2019,"Fat mass tended to be lower, and fat-free mass correspondingly higher, by BIA than by ADP or D 2 O.","['1752 patients', 'malnourished HIV-infected adults referred for antiretroviral therapy', 'malnourished HIV patients', 'malnourished HIV-infected patients starting antiretroviral therapy (ART', 'ART-eligible HIV-infected patients with BMI <18·5']","['Lipid-based nutrient supplements (LNS', 'vitamins and minerals to LNS', 'nutritional intervention', 'LNS or LNS with added high-dose vitamins and minerals (LNS-VM']","['Body composition by bioelectrical impedance analysis (BIA), deuterium ( 2 H) diluted water (D 2 O) and air displacement plethysmography (ADP), and handgrip strength', 'body composition and handgrip strength', 'Fat mass', 'handgrip strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",1752.0,0.254958,"Fat mass tended to be lower, and fat-free mass correspondingly higher, by BIA than by ADP or D 2 O.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'PrayGod', 'Affiliation': 'Mwanza Research Centre, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Rehman', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jonathan C K', 'Initials': 'JCK', 'LastName': 'Wells', 'Affiliation': 'Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Chisenga', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Siame', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Kidola', 'Initials': 'K', 'LastName': 'Jeremiah', 'Affiliation': 'Mwanza Research Centre, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Lackson', 'Initials': 'L', 'LastName': 'Kasonka', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Woodd', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Changalucha', 'Affiliation': 'Mwanza Research Centre, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Barts and the London School of Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Koethe', 'Affiliation': 'Vanderbilt Institute for Global Health, Vanderbilt University Medical Centre, Nashville, TN, USA.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Heimburger', 'Affiliation': 'Vanderbilt Institute for Global Health, Vanderbilt University Medical Centre, Nashville, TN, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Filteau', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}]",Journal of nutritional science,['10.1017/jns.2019.15']
3477,32047021,TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient-a feasibility study protocol.,"INTRODUCTION


Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker.
METHODS AND ANALYSIS


The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial.
ETHICS AND DISSEMINATION


Ethical approval for the study was given by the South West-Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences.
TRIAL REGISTRATION NUMBER


ISRCTN10649958.",2020,"A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury.",['Participants will be recruited from major trauma centres'],"['TULIP', 'operative or non-operative management of their injuries', 'surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1']","['health-related quality of life, functional outcome and pain']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}]","[{'cui': 'C0331680', 'cui_str': 'Tulip'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.126724,"A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Barnfield', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK jenny.ingram@bristol.ac.uk.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Halliday', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Griffin', 'Affiliation': 'Nuffield Dept of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Greenwood', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Level 3 Education Centre, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Department of Anaesthetics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Glynn', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McArthur', 'Affiliation': 'Department of Orthopaedics, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bates', 'Affiliation': 'Department of Orthopaedics, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Mehool', 'Initials': 'M', 'LastName': 'Acharya', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036588']
3478,31963773,"Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial.","The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.",2020,"The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation.","['people with Fibromyalgia (NAT-FM', '160 patients with fibromyalgia']","['Multicomponent Intervention', 'treatment-as-usual (TAU) and NAT-FM+TAU', 'mixed group (NAT-FM+TAU vs. TAU', 'nature activity therapy']","['positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation', 'mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score', 'Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0067787', 'cui_str': 'TalANAc'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0067787', 'cui_str': 'TalANAc'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C2004436', 'cui_str': 'Activity therapy (regime/therapy)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0067787', 'cui_str': 'TalANAc'}]",160.0,0.169705,"The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation.","[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Serrat', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d'Hebron, 08035 Barcelona, Spain.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': 'Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Elna', 'Initials': 'E', 'LastName': 'García-Troiteiro', 'Affiliation': 'Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fontcuberta', 'Affiliation': 'Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Corel', 'Initials': 'C', 'LastName': 'Mateo-Canedo', 'Affiliation': 'Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Míriam', 'Initials': 'M', 'LastName': 'Almirall', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d'Hebron, 08035 Barcelona, Spain.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Jorge Luis', 'Initials': 'JL', 'LastName': 'Méndez-Ulrich', 'Affiliation': 'Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sanz', 'Affiliation': 'Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Esplugues de Llobregat, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17020634']
3479,31963904,Intervention Strategies to Elicit MVPA in Preschoolers during Outdoor Play.,"Approximately 50% of preschoolers do not meet physical activity recommendations and children who reside in low-income rural communities may be further at risk for higher levels of sedentary behavior. Outdoor play is essential for preschool children; however, literature is unclear as to which types of interventions elicit moderate-to-vigorous physical activity (MVPA) for all preschoolers. The aim of this study was to determine which type of intervention, physical activity or fundamental motor skill focus, elicits MVPA during outdoor play. Ninety-eight preschool children (M age = 4.48 years) from one Head Start center participated in an outdoor play intervention two days per week for 7 weeks. Classes were randomly assigned to one of four groups: fundamental motor skill focus (FMS), physical activity focus (PA), FMS and PA (FMS + PA), and control. An accelerometer worn on the hip measured MVPA. Results showed that age, sex and group assignment contributed to MVPA at the beginning of the intervention and age, sex, group assignment and MVPA during the beginning of the intervention contributed to MVPA at the end of the intervention. Overall, the FMS + PA group elicited MVPA from males and females of all ages. Interventions that combine both FMS and PA may reduce physical activity disparities in preschool children.",2020,"Results showed that age, sex and group assignment contributed to MVPA at the beginning of the intervention and age, sex, group assignment and MVPA during the beginning of the intervention contributed to MVPA at the end of the intervention.","['Ninety-eight preschool children (M age = 4.48 years) from one Head Start center participated in an', 'Preschoolers during Outdoor Play', 'preschool children']","['outdoor play intervention', 'FMS + PA', 'FMS and PA', 'fundamental motor skill focus (FMS), physical activity focus (PA), FMS and PA (FMS + PA), and control']",['physical activity disparities'],"[{'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",98.0,0.0189394,"Results showed that age, sex and group assignment contributed to MVPA at the beginning of the intervention and age, sex, group assignment and MVPA during the beginning of the intervention contributed to MVPA at the end of the intervention.","[{'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Wadsworth', 'Affiliation': 'Exercise Adherence and Obesity Prevention Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Auburn, AL 36849, USA.'}, {'ForeName': 'Jerraco L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Pediatric Movement Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Auburn, AL 36849, USA.'}, {'ForeName': 'Alexandra V', 'Initials': 'AV', 'LastName': 'Carroll', 'Affiliation': 'Exercise Adherence and Obesity Prevention Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Auburn, AL 36849, USA.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Pangelinan', 'Affiliation': 'Pediatric Movement Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Auburn, AL 36849, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Rudisill', 'Affiliation': 'Pediatric Movement Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Auburn, AL 36849, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sassi', 'Affiliation': 'Pediatric Movement Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Auburn, AL 36849, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17020650']
3480,31412937,"Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial.","BACKGROUND


Globally, eye care provision is currently insufficient to meet the requirement for eye care services. Lack of access and awareness are key barriers to specialist services; in addition, specialist services are over-utilised by people with conditions that could be managed in the community or primary care. In combination, these lead to a large unmet need for eye health provision. We have developed a validated smartphone-based screening algorithm (Peek Community Screening App). The application (App) is part of the Peek Community Eye Health system (Peek CEH) that enables Community Volunteers (CV) to make referral decisions about patients with eye problems. It generates referrals, automated short messages service (SMS) notifications to patients or guardians and has a program dashboard for visualising service delivery. We hypothesise that a greater proportion of people with eye problems will be identified using the Peek CEH system and that there will be increased uptake of referrals, compared to those identified and referred using the current community screening approaches.
STUDY DESIGN


A single masked, cluster randomised controlled trial design will be used. The unit of randomisation will be the 'community unit', defined as a dispensary or health centre with its catchment population. The community units will be allocated to receive either the intervention (Peek CEH system) or the current care (periodic health centre-based outreach clinics with onward referral for further treatment). In both arms, a triage clinic will be held at the link health facility four weeks from sensitisation, where attendance will be ascertained. During triage, participants will be assessed and treated and, if necessary, referred onwards to Kitale Eye Unit.
DISCUSSION


We aim to evaluate a M-health system (Peek CEH) geared towards reducing avoidable blindness through early identification and improved adherence to referral for those with eye problems and reducing demand at secondary care for conditions that can be managed effectively at primary care level.
TRIAL REGISTRATION


The Pan African Clinical Trials Registry (PACTR), 201807329096632 . Registered on 8 June 2018.",2019,"It generates referrals, automated short messages service (SMS) notifications to patients or guardians and has a program dashboard for visualising service delivery.","['Trans Nzoia County, Kenya']","['intervention (Peek CEH system) or the current care (periodic health centre-based outreach clinics with onward referral for further treatment', 'M-health system (Peek CEH']",[],"[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]","[{'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0581047', 'cui_str': 'Outreach clinic (environment)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.173646,"It generates referrals, automated short messages service (SMS) notifications to patients or guardians and has a program dashboard for visualising service delivery.","[{'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Rono', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Hillary.Rono@lshtm.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bastawrous', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Wanjala', 'Affiliation': 'Kitale County referral and teaching Hospital, Ravine Road, P.O. Box 98, Kitale, 30200, Kenya.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gichuhi', 'Affiliation': 'Department of Ophthalmology, University of Nairobi, P.O. Box 19676, Nairobi, 00202, Kenya.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",Trials,['10.1186/s13063-019-3615-x']
3481,31771385,Child Caries Management: A Randomized Controlled Trial in Dental Practice.,"This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co-primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P,  n  = 386; B+P,  n  = 381; PA,  n  = 377) by 72 general dental practitioners, of whom 1,058 (C+P,  n  = 352; B+P,  n  = 352; PA,  n  = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).",2020,There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P.,"['1,144 participants were randomized (C+P,  n  = 386; B+P,  n  = 381; PA,  n  = 377) by 72 general dental practitioners, of whom 1,058 (C+P,  n  = 352; B+P,  n  = 352; PA,  n  = 354) attended at least 1 study visit and were included in the primary analysis', 'Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion', 'Child Caries Management', '3 y for managing dental caries in primary teeth in UK primary dental care', 'participants with at least 1 episode of dental pain and/or infection were as follows']","['centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants', 'C+P']","['incidence or number of episodes of dental pain and/or infection', 'incidence of dental pain and/or infection', 'proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection', 'mean (SD) number of episodes of dental pain and/or infection']","[{'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1144.0,0.369859,There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P.,"[{'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Innes', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'G V A', 'Initials': 'GVA', 'LastName': 'Douglas', 'Affiliation': 'School of Dentistry, University of Leeds, Leeds, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Homer', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Marshman', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abouhajar', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Holmes', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chadwick', 'Affiliation': 'School of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deery', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Institute of Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.'}]",Journal of dental research,['10.1177/0022034519888882']
3482,31159814,Identification of two microRNA signatures in whole blood as novel biomarkers for diagnosis of nasopharyngeal carcinoma.,"BACKGROUND


Early diagnosis is critical to reduce the mortality caused by nasopharyngeal carcinoma (NPC). MicroRNAs (miRNAs) are dysregulated and play important roles in carcinogenesis. Therefore, this study aimed to identify diagnostically relevant circulating miRNA signatures in patients with NPC.
METHODS


Total RNA was extracted from whole blood samples obtained from 120 patients with NPC, 30 patients with head-neck tumors (HNT), and 30 healthy subjects (HSs), and examined by using a custom microarray. The expression levels of four miRNAs identified by using the microarray were validated with quantitative real-time reverse transcription polymerase chain reaction. The 120 patients with NPC and 30 HSs were randomly assigned to training group-1 and validation group-1, respectively. By using significance analysis of microarray (SAM), the specific miRNA expression profiles in whole blood from patients with NPC are obtained. By using lasso regression and adaptive boosting, a diagnostic signature was identified in training group-1, and its accuracy was verified in validation group-1. By using the same methods, another signature to distinguish patients with NPC from those with HNT and HSs was identified in training group-2 and confirmed in validation group-2.
RESULTS


There were 117 differentially expressed miRNAs (upregulated and downregulated fold change ≥ 1.5) between the patients with NPC and HSs, among which an 8-miRNA signature was identified with 96.43% sensitivity and 100% specificity [area under the curve (AUC) = 0.995] to diagnose NPC in training group-1 and 86.11% sensitivity and 88.89% specificity (AUC = 0.941) in validation group-1. Compared with traditional Epstein-Barr virus (EBV) seromarkers, this signature was more specific for NPC. Furthermore, a 16-miRNA signature to differentiate NPC from HNT and HS (HNT-HS) was established from 164 differentially expressed miRNAs, which diagnosed NPC and HNT-HS with 100% accuracy (AUC = 1.000) in training group-2 and 87.04% (AUC = 0.924) in validation group-2.
CONCLUSIONS


The present study identified two miRNA signatures for the highly accurate diagnosis and differential diagnosis of patients with NPC from HSs and patients with HNT. The identified miRNAs might represent novel serological biomarkers and potential therapeutic targets for NPC.",2019,The expression levels of four miRNAs identified by using the microarray were validated with quantitative real-time reverse transcription polymerase chain reaction.,"['patients with NPC from HSs and patients with HNT', 'patients with NPC', 'Total RNA was extracted from whole blood samples obtained from 120 patients with NPC, 30 patients with head-neck tumors (HNT), and 30 healthy subjects (HSs), and examined by using a custom microarray', '120 patients with NPC and 30 HSs']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0444256', 'cui_str': 'Whole blood sample (specimen)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0162343', 'cui_str': 'Customs'}]",[],[],30.0,0.0186717,The expression levels of four miRNAs identified by using the microarray were validated with quantitative real-time reverse transcription polymerase chain reaction.,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Shi-Juan', 'Initials': 'SJ', 'LastName': 'Mai', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Huan-Xin', 'Initials': 'HX', 'LastName': 'Lin', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Mei-Yin', 'Initials': 'MY', 'LastName': 'Zhang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Jia-Ling', 'Initials': 'JL', 'LastName': 'Huang', 'Affiliation': 'Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Zhi-Qing', 'Initials': 'ZQ', 'LastName': 'Long', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Zi-Jian', 'Initials': 'ZJ', 'LastName': 'Lu', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'Sun', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Sai-Lan', 'Initials': 'SL', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Hui-Yun', 'Initials': 'HY', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China. wanghyun@mail.sysu.edu.cn.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China. guoling@sysucc.org.cn.""}]",Journal of translational medicine,['10.1186/s12967-019-1923-2']
3483,32068667,"A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain.","This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain.",2020,"Participants within each condition showed significant reductions from pre to post-treatment in pain intensity (mean changes ranged from = -2.58-3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04-4.29, Cohen's d's = 0.54-0.88).","['patients with chronic back pain', 'low back pain', 'Participants (n=142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who']","['medicine placebo', 'tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT', 'desipramine, CBT', 'placebo', 'CBT and active placebo medication (benzotropine mesylate, 0.125mg); 3) low concentration desipramine and CBT; and 4) active benztropine placebo medication', 'desipramine, cognitive behavioral therapy, and active placebo therapy', 'low concentration desipramine']","['Differential Description Scale and Roland-Morris Disability Questionnaires pre', 'pain intensity', 'pain disability', 'chronic back pain intensity or disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003290', 'cui_str': 'Antidepressant Drugs, Tricyclic'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3645051', 'cui_str': 'mesylate'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005098', 'cui_str': 'benzatropine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",142.0,0.562883,"Participants within each condition showed significant reductions from pre to post-treatment in pain intensity (mean changes ranged from = -2.58-3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04-4.29, Cohen's d's = 0.54-0.88).","[{'ForeName': 'Hilary M', 'Initials': 'HM', 'LastName': 'Gould', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Joseph Hampton', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Chircop-Rollick', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DʼAndrea', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Garfin', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Shetal M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Funk', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Donald B', 'Initials': 'DB', 'LastName': 'Penzien', 'Affiliation': 'Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Weickgenanta', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slater', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, AZ, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutledge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}]",Pain,['10.1097/j.pain.0000000000001834']
3484,31798841,Hand hygiene - social network analysis of peer-identified and management-selected change agents.,"Background


Hand hygiene compliance can be improved by strategies fostering collaborative efforts among healthcare workers (HCWs) through change agents. However, there is limited information about how change agents shape the social networks of work teams, and how this relates to organisational culture. The objectives of this study were to describe the influence of peer-identified change agents (PICAs) and management-selected change agents (MSCAs) on hand hygiene, perception of their leadership style by peers, and the role of the organisational culture in the process of hand hygiene promotion.
Methods


This study, stratified in pre-, during, and post-intervention periods, was conducted between February 2017 and March 2018 in two wards at a tertiary care hospital in Malaysia. Hand hygiene promotion was facilitated either by PICAs (study arm 1) or MSCAs (study arm 2), and the two wards were randomly allocated to one of the two interventions. Outcomes were: 1) perceived leadership styles of PICAs and MSCAs by staff, vocalised during question and answer sessions; 2) the social network connectedness and communication patterns between HCWs and change agents by applying social network analysis; and 3) hand hygiene leadership attributes obtained from HCWs in the post-intervention period by questionnaires.
Results


Hand hygiene compliance in study arm 1 and study arm 2 improved by from 48% (95% CI: 44-53%) to 66% (63-69%), and from 50% (44-55%) to 65% (60-69%), respectively. There was no significant difference between the two arms. Healthcare workers perceived that PICAs lead by example, while MSCAs applied an authoritarian top-down leadership style. The organisational culture of both wards was hierarchical, with little social interaction, but strong team cohesion. Position and networks of both PICAs and MSCAs were similar and generally weaker compared to the leaders who were nominated by HCWs in the post-intervention period. Healthcare workers on both wards perceived authoritative leadership to be the most desirable attribute for hand hygiene improvement.
Conclusion


Despite experiencing successful hand hygiene improvement from PICAs, HCWs expressed a preference for the existing top-down leadership structure. This highlights the limits of applying leadership models that are not supported by the local organisational culture.",2019,Position and networks of both PICAs and MSCAs were similar and generally weaker compared to the leaders who were nominated by HCWs in the post-intervention period.,['February 2017 and March 2018 in two wards at a tertiary care hospital in Malaysia'],['peer-identified change agents (PICAs) and management-selected change agents (MSCAs'],"['leadership styles of PICAs and MSCAs by staff, vocalised during question and answer sessions; 2) the social network connectedness and communication patterns between HCWs and change agents by applying social network analysis; and 3) hand hygiene leadership attributes obtained from HCWs', 'Position and networks of both PICAs and MSCAs']","[{'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0564182', 'cui_str': 'Vocalizing'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1171218', 'cui_str': 'Social network analysis'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",,0.041767,Position and networks of both PICAs and MSCAs were similar and generally weaker compared to the leaders who were nominated by HCWs in the post-intervention period.,"[{'ForeName': 'Yew Fong', 'Initials': 'YF', 'LastName': 'Lee', 'Affiliation': '1Institute of Global Health, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Mary-Louise', 'Initials': 'ML', 'LastName': 'McLaws', 'Affiliation': '3School of Public Health and Community Medicine, UNSW Medicine, UNSW Sydney, Level 3 Samuels Building, Sydney, NSW 2052 Australia.'}, {'ForeName': 'Loke Meng', 'Initials': 'LM', 'LastName': 'Ong', 'Affiliation': '4Clinical Research Centre & Department of Medicine, Hospital Pulau Pinang, Georgetown, Malaysia.'}, {'ForeName': 'Suraya', 'Initials': 'S', 'LastName': 'Amir Husin', 'Affiliation': '2Ministry of Health, Putrajaya, Malaysia.'}, {'ForeName': 'Hock Hin', 'Initials': 'HH', 'LastName': 'Chua', 'Affiliation': '5Sarawak General Hospital, Kuching, Sarawak Malaysia.'}, {'ForeName': 'See Yin', 'Initials': 'SY', 'LastName': 'Wong', 'Affiliation': '5Sarawak General Hospital, Kuching, Sarawak Malaysia.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Pittet', 'Affiliation': '6Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Zingg', 'Affiliation': '6Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-019-0644-x']
3485,31668721,"A randomized, controlled, double-blind crossover study on the effects of isoeffective and isovolumetric intravenous crystalloid and gelatin on blood volume, and renal and cardiac hemodynamics.","BACKGROUND & AIMS


Blood volume expanding properties of colloids are superior to crystalloids. In addition to oncotic/osmotic properties, the electrolyte composition of infusions may have important effects on visceral perfusion, with infusions containing supraphysiological chloride causing hyperchloremic acidosis and decreased renal blood flow. In this non-inferiority study, a validated healthy human subject model was used to compare effects of colloid (4% succinylated gelatin) and crystalloid fluid regimens on blood volume, renal function, and cardiac output.
METHODS


Healthy male participants were given infusions over 60 min > 7 days apart in a randomized, crossover manner. Reference arm (A): 1.5 L of Sterofundin ISO, isoeffective arm (B): 0.5 L of 4% Gelaspan®, isovolumetric arm (C): 0.5 L of 4% Gelaspan® and 1 L of Sterofundin ISO (all B. Braun, Melsungen, Germany). Participants were studied over 240 min. Changes in blood volume were calculated from changes in weight and hematocrit. Renal volume, renal artery blood flow (RABF), renal cortex perfusion and diffusion, and cardiac index were measured with magnetic resonance imaging.
RESULTS


Ten of 12 males [mean (SE) age 23.9 (0.8) years] recruited, completed the study. Increase in body weight and extracellular fluid volume were significantly less after infusion B than infusions A and C, but changes in blood volume did not significantly differ between infusions. All infusions increased renal volume, with no significant differences between infusions. There was no significant difference in RABF across the infusion time course or between infusion types. Renal cortex perfusion decreased during the infusion (mean 18% decrease from baseline), with no significant difference between infusions. There was a trend for increased renal cortex diffusion (4.2% increase from baseline) for the crystalloid infusion. All infusions led to significant increases in cardiac index.
CONCLUSIONS


A smaller volume of colloid (4% succinylated gelatin) was as effective as a larger volume of crystalloid at expanding blood volume, increasing cardiac output and changing renal function. Significantly less interstitial space expansion occurred with the colloid.
TRIAL REGISTRATION


The protocol was registered with the European Union Drug Regulating Authorities Clinical Trials Database (https://eudract.ema.europa.eu) (EudraCT No. 2013-003260-32).",2020,There was a trend for increased renal cortex diffusion (4.2% increase from baseline) for the crystalloid infusion.,"['Ten of 12 males [mean (SE) age 23.9 (0.8) years] recruited, completed the study', 'Healthy male participants']","['infusions over 60\xa0min', 'isoeffective and isovolumetric intravenous crystalloid and gelatin', 'Sterofundin ISO, isoeffective arm (B): 0.5\xa0L of 4% Gelaspan®, isovolumetric arm (C): 0.5\xa0L of 4% Gelaspan® and 1\xa0L of Sterofundin ISO', 'colloid (4% succinylated gelatin) and crystalloid fluid regimens']","['renal volume', 'renal cortex diffusion', 'RABF', 'blood volume, renal function, and cardiac output', 'Renal volume, renal artery blood flow (RABF), renal cortex perfusion and diffusion, and cardiac index', 'cardiac index', 'Renal cortex perfusion', 'renal blood flow', 'body weight and extracellular fluid volume', 'interstitial space expansion', 'blood volume', 'blood volume, and renal and cardiac hemodynamics', 'cardiac output and changing renal function']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0630627', 'cui_str': 'sterofundin'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0143961', 'cui_str': 'succinylated gelatin'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0022655', 'cui_str': 'Kidney Cortex'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1527409', 'cui_str': 'Renal blood flow, function (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015349', 'cui_str': 'Extracellular Fluid'}, {'cui': 'C0225319', 'cui_str': 'Interstitial space (body structure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0853947,There was a trend for increased renal cortex diffusion (4.2% increase from baseline) for the crystalloid infusion.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bradley', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.""}, {'ForeName': 'Damian D', 'Initials': 'DD', 'LastName': 'Bragg', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Eleanor F', 'Initials': 'EF', 'LastName': 'Cox', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.""}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'El-Sharkawy', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Buchanan', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Abeed H', 'Initials': 'AH', 'LastName': 'Chowdhury', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': ""School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Francis', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.""}, {'ForeName': 'Dileep N', 'Initials': 'DN', 'LastName': 'Lobo', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK. Electronic address: dileep.lobo@nottingham.ac.uk.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.09.011']
3486,31678945,Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.,"INTRODUCTION


Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.
METHODS AND ANALYSIS


A multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.
ETHICS AND DISSEMINATION


Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2 nd  July 2018.
TRIAL REGISTRATION NUMBER


ISRCTN16612336.",2019,"Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group.","['48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK', 'adults aged 50 years and over after ankle fracture', 'adults, with prognosis worsening with increasing age', 'adults aged 50 years or over after ankle fracture']","['Progressive functional exercise versus best practice advice', 'central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy', 'progressive functional exercise']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",[],,0.164832,"Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK david.keene@ndorms.ox.ac.uk.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tutton', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vicki S', 'Initials': 'VS', 'LastName': 'Barber', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Redmond', 'Affiliation': 'Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Willett', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030877']
3487,30674279,Pain management in acute otitis media: a qualitative study of parents' views and expectations.,"BACKGROUND


For unclarified reasons, parents tend to be cautious about administering analgesics to their children, potentially leading to suboptimal management of AOM symptoms. We aim to understand parents' views and expectations of pain management in acute otitis media (AOM) in children.
METHODS


Qualitative study alongside a cluster-randomised controlled trial (PIM-POM study) aimed at optimising pain management in childhood AOM. We purposefully sampled 14 parents of children diagnosed with AOM by their GP, who were recruited to the trial between November 2017 and May 2018. Semi-structured interviews were held at home in the first two weeks after trial enrollment. Interviews were audio-recorded, transcribed and analyzed thematically.
RESULTS


Parents experienced difficulties in recognising earache and other symptoms of an ear infection. They consulted the GP for a diagnosis, for reassurance and for management advice. Parents shared that, prior to consultation, they had insufficient knowledge of the benefits of correctly dosed pain medication at regularly scheduled intervals. Parents valued the GP's advice on pain management, and were happy to accept pain medication as standalone therapy, provided that the GP explained why antibiotics would not be needed. Parents' views and expectations of pain management in AOM were shaped by previous experiences of AOM within their family; those with a positive experience of pain medication are more likely to use it in subsequent AOM episodes.
CONCLUSIONS


Parents of children with AOM consult the GP to help cope with uncertainties in recognising symptoms of AOM, and to receive management advice. It is important that GPs are aware of parents' lack of understanding of the role of pain medication in managing AOM, and that they address this during the consultation.
TRIAL REGISTRATION


Netherlands Trial Register, identifier NTR4920 (registration date: 19 December 2014).",2019,"Parents' views and expectations of pain management in AOM were shaped by previous experiences of AOM within their family; those with a positive experience of pain medication are more likely to use it in subsequent AOM episodes.
","['14 parents of children diagnosed with AOM by their GP, who were recruited to the trial between November 2017 and May 2018', 'acute otitis media (AOM) in children', 'childhood AOM', 'acute otitis media']",['Pain management'],['recognising earache and other symptoms of an ear infection'],"[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media (disorder)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0699744', 'cui_str': 'Infection of ear'}]",,0.0545829,"Parents' views and expectations of pain management in AOM were shaped by previous experiences of AOM within their family; those with a positive experience of pain medication are more likely to use it in subsequent AOM episodes.
","[{'ForeName': 'Rick T', 'Initials': 'RT', 'LastName': 'van Uum', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, Office number FAC 5.09, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands. R.T.vanUum-2@umcutrecht.nl.'}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Venekamp', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, Office number FAC 5.09, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Anne G M', 'Initials': 'AGM', 'LastName': 'Schilder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, Office number FAC 5.09, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Roger A M J', 'Initials': 'RAMJ', 'LastName': 'Damoiseaux', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, Office number FAC 5.09, P.O. Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Sibyl', 'Initials': 'S', 'LastName': 'Anthierens', 'Affiliation': 'Department of Primary Care and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.'}]",BMC family practice,['10.1186/s12875-019-0908-9']
3488,31554943,Effect of multiple subconjunctival conbercept injections as an adjuvant to the surgical treatment of pterygium: a prospective randomised comparative 6-month follow-up study.,"OBJECTIVE


To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery.
METHODS


As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out.
RESULTS


There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078).
CONCLUSION


Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.",2020,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","['pterygium', '96 eyes from 96 patients with a tendency to recur', 'pterygium patients after surgery']","['5-Fu', 'multiple subconjunctival conbercept injections', 'conbercept and 5-fluorouracil', 'multiple subconjunctival injections of conbercept', 'subconjunctival injections of conbercept (0.2\u2009ml) or 5-fluorouracil']","['corneal abrasions', 'pterygium morphology, colour intensity, recurrence, and complications', 'subconjunctival haemorrhage', 'persistent epithelial defects', 'safe, effective, and well-tolerated', 'recurrence', 'pterygium morphology', 'safety and efficacy']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0010032', 'cui_str': 'Corneal abrasion (disorder)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0163744,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Quanxi', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Donglai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Honghu, No 142. Xinjian Road, 433202, Honghu, Hubei, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China. keminyk@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0596-7']
3489,31838259,Wood stove interventions and child respiratory infections in rural communities: KidsAir rationale and methods.,"BACKGROUND


Acute lower respiratory tract infections (LRTIs) account for >27% of all hospitalizations among US children under five years of age. Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards. This is concerning as PM 2.5  exposure is associated with many adverse health outcomes, including a greater than three-fold increased risk of LRTIs. Evidence-based efforts are warranted in rural and American Indian/Alaska Native (AI/AN) communities in the US that suffer from elevated rates of childhood LRTI and commonly use wood for residential heating.
DESIGN


In three rural and underserved settings, we conducted a three-arm randomized controlled, post-only intervention trial in wood stove homes with children less than five years old. Education and household training on best-burn practices were introduced as one intervention arm (Tx1). This intervention was evaluated against an indoor air filtration unit arm (Tx2), as well as a control arm (Tx3). The primary outcome was LRTI incidence among children under five years of age.
DISCUSSION


To date, exposure reduction strategies in wood stove homes have been either inconsistently effective or include factors that limit widespread dissemination and continued compliance in rural and economically disadvantaged populations. As part of the ""KidsAIR"" study described herein, the overall hypothesis was that a low-cost, educational intervention targeting indoor wood smoke PM 2.5  exposures would be a sustainable approach for reducing children's risk of LRTI in rural and AI/AN communities.",2020,Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards.,"['wood stove homes with children less than five years old', 'rural communities', 'In three rural and underserved settings']","['Education and household training', 'Wood stove interventions']",['LRTI incidence among children under five years of age'],"[{'cui': 'C1268550', 'cui_str': 'Wood stove'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1268550', 'cui_str': 'Wood stove'}]","[{'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.0646851,Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards.,"[{'ForeName': 'Curtis W', 'Initials': 'CW', 'LastName': 'Noonan', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA. Electronic address: curtis.noonan@umontana.edu.'}, {'ForeName': 'Erin O', 'Initials': 'EO', 'LastName': 'Semmens', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Desirae', 'Initials': 'D', 'LastName': 'Ware', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Bert B', 'Initials': 'BB', 'LastName': 'Boyer', 'Affiliation': 'Center for Alaska Native Health Research, University of Alaska Fairbanks, AK, USA; Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Erdei', 'Affiliation': 'Community Environmental Health Program, University of New Mexico College of Pharmacy, Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Scarlett E', 'Initials': 'SE', 'LastName': 'Hopkins', 'Affiliation': 'Center for Alaska Native Health Research, University of Alaska Fairbanks, AK, USA; Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'Johnnye', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'Community Environmental Health Program, University of New Mexico College of Pharmacy, Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Tony J', 'Initials': 'TJ', 'LastName': 'Ward', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105909']
3490,31387606,Further analyses of the safety of verubecestat in the phase 3 EPOCH trial of mild-to-moderate Alzheimer's disease.,"BACKGROUND


Verubecestat, a BACE1 inhibitor that reduces Aβ levels in the cerebrospinal fluid of humans, was not effective in a phase 3 trial (EPOCH) of mild-to-moderate AD and was associated with adverse events. To assist in the development of BACE1 inhibitors, we report detailed safety findings from EPOCH.
METHODS


EPOCH was a randomized, double-blind, placebo-controlled 78-week trial evaluating verubecestat 12 mg and 40 mg in participants with mild-to-moderate AD diagnosed clinically. The trial was terminated due to futility close to its scheduled completion. Of 1957 participants who were randomized and took treatment, 652 were assigned to verubecestat 12 mg, 652 to verubecestat 40 mg, and 653 to placebo. Adverse events and relevant laboratory, vital sign, and ECG findings were assessed.
RESULTS


Verubecestat 12 mg and 40 mg were associated with an increase in the percentage of participants reporting adverse events versus placebo (89 and 92% vs. 82%), although relatively few participants discontinued treatment due to adverse events (8 and 9% vs. 6%). Adverse events that were increased versus placebo included falls and injuries, suicidal ideation, weight loss, sleep disturbance, rash, and hair color change. Most were mild to moderate in severity. Treatment differences in suicidal ideation emerged within the first 3 months but did not appear to increase after 6 months. In contrast, treatment differences in falls and injuries continued to increase over time.
CONCLUSIONS


Verubecestat was associated with increased risk for several types of adverse events. Falls and injuries were notable for progressive increases over time. While the mechanisms underlying the increased adverse events are unclear, they may be due to BACE inhibition and should be considered in future clinical development programs of BACE1 inhibitors.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01739348 , registered on 29 November 2012.",2019,"Adverse events that were increased versus placebo included falls and injuries, suicidal ideation, weight loss, sleep disturbance, rash, and hair color change.","['registered on 29 November 2012', 'participants with mild-to-moderate AD diagnosed clinically', ""mild-to-moderate Alzheimer's disease"", '1957 participants']",['placebo'],"['falls and injuries, suicidal ideation, weight loss, sleep disturbance, rash, and hair color change', 'adverse events', 'percentage of participants reporting adverse events', 'Adverse events', 'suicidal ideation', 'Adverse events and relevant laboratory, vital sign, and ECG findings']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0474378', 'cui_str': 'Hair color change (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0518766'}, {'cui': 'C0438154', 'cui_str': 'ECG finding'}]",1957.0,0.308377,"Adverse events that were increased versus placebo included falls and injuries, suicidal ideation, weight loss, sleep disturbance, rash, and hair color change.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Egan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. michael.egan@merck.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Tiffini', 'Initials': 'T', 'LastName': 'Voss', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kost', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Furtek', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mahoney', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Cummings', 'Affiliation': 'University of Nevada Las Vegas Department of Brain Health, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.'}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, AZ, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Aisen', 'Affiliation': 'University of Southern California, San Diego, CA, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': ""Gerontopole, INSERM U 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lines', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Alzheimer's research & therapy,['10.1186/s13195-019-0520-1']
3491,31315872,Protocol for a feasibility trial to inform the development of a breathlessness rehabilitation programme for chronic obstructive pulmonary disease and chronic heart failure (the COHERE trial).,"INTRODUCTION


Adults with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) commonly suffer from exertional dyspnoea and fatigue. Exercise training is recommended in the management of both diseases, yet many of the outcome measures traditionally reported are disease specific and may not fully acknowledge the multimorbid older adult. Based on our previous research, a breathlessness rehabilitation programme for patients with COPD/CHF or combined disease has been introduced as a service improvement within University Hospital Leicester National Health Service Trust and has amalgamated aspects of cardiac and pulmonary rehabilitation. This has created an opportunity to expand the outcome measures assessed and introduce a holistic approach in a population that share common symptoms. Therefore, this multisite trial will explore the feasibility of collecting novel outcome markers as part of a comprehensive assessment prior to enrolment in a breathlessness rehabilitation programme for participants with COPD and/or CHF.
METHODS AND ANALYSIS


The rehabilitation programme consists of 12 sessions, twice weekly, over a 6-week period. In addition to usual rehabilitation outcome measures, the trial will collect measures of future cardiometabolic risk including arterial stiffness, body composition, physical activity/sedentary time, frailty and symptom burden in a comprehensive rehabilitation assessment. The primary outcome measures will centre around feasibility (eg, acceptability of the comprehensive rehabilitation assessment, intervention delivery and the experiences and attitudes of healthcare professionals and participants). Focus groups and interviews will be conducted to further explore barriers and facilitators to the operation and participation in a breathlessness rehabilitation programme and the trial. Thematic analysis will be used for the interpretation of all qualitative data.
ETHICS AND DISSEMINATION


The research ethics committee East Midlands Leicester-Central has provided ethical approval for the conduct of this trial. The results of the trial will be disseminated through appropriate conference proceedings and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ISRCTN11636308.",2019,"Based on our previous research, a breathlessness rehabilitation programme for patients with COPD/CHF or combined disease has been introduced as a service improvement within University Hospital Leicester National Health Service Trust and has amalgamated aspects of cardiac and pulmonary rehabilitation.","['participants with COPD and/or CHF', 'Adults with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) commonly suffer from exertional dyspnoea and fatigue', 'patients with COPD/CHF or combined disease']","['Exercise training', 'breathlessness rehabilitation programme']","['future cardiometabolic risk including arterial stiffness, body composition, physical activity/sedentary time, frailty and symptom burden in a comprehensive rehabilitation assessment', 'centre around feasibility (eg, acceptability of the comprehensive rehabilitation assessment, intervention delivery and the experiences and attitudes of healthcare professionals and participants', 'chronic obstructive pulmonary disease and chronic heart failure']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1827122', 'cui_str': 'Rehabilitation assessment (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]",,0.0709069,"Based on our previous research, a breathlessness rehabilitation programme for patients with COPD/CHF or combined disease has been introduced as a service improvement within University Hospital Leicester National Health Service Trust and has amalgamated aspects of cardiac and pulmonary rehabilitation.","[{'ForeName': 'Amy V', 'Initials': 'AV', 'LastName': 'Jones', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Evans', 'Affiliation': 'Centre for Exercise and Rehabilitation Sciences, Leicester Biomedical Research Centre-Respiratory, National Institute for Health Research, Leicester, UK.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Esliger', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Sherar', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'Centre for Exercise and Rehabilitation Sciences, Leicester Biomedical Research Centre-Respiratory, National Institute for Health Research, Leicester, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029387']
3492,30889096,Safety and feasibility of estrogen receptor-β targeted phytoSERM formulation for menopausal symptoms: phase 1b/2a randomized clinical trial.,"OBJECTIVE


PhytoSERM is a formulation of genistein, daidzein, and S-equol that has an 83-fold selective affinity for estrogen receptor-β (ERβ); and may enhance neuron function and estrogenic mechanisms in the brain without having peripheral estrogenic activity.
METHODS


We conducted an overarching, two-stage, dose-ranging, double-blinded, randomized, placebo-controlled trial of 12 weeks duration comparing 50 and 100 mg/d of phytoSERM with placebo for noncognitively impaired, perimenopausal women aged 45 to 60, with intact uteri and ovaries, with at least one cognitive complaint, and one vasomotor-related symptom. Primary objectives were to assess safety and tolerability of a 50 and 100 mg daily dose; and, secondly, to evaluate potential indicators of efficacy on cognition and vasomotor symptoms over 4 and 12 weeks, and using an embedded, 4-week, 2-period, placebo-controlled crossover trial for a subset of participants.
RESULTS


Seventy-one women were randomized to treatment; 70 were evaluated at 4 weeks; 12 were entered into the crossover study; 5 did not complete 12 weeks. Reasons for discontinuation were withdrawal of consent (n = 1) and lost to follow-up (n = 4). Adverse events occurred in 16.7% (n = 4) placebo, 39.1% (n = 9) 50 mg/d, and 29.2% (n = 7) 100 mg/d treated participants; 85% were mild and none was severe. Vaginal bleeding occurred in 0, placebo; 1, 50 mg; and 3, 100 mg/d participants.
CONCLUSIONS


The phytoSERM formulation was well tolerated at 50 and 100 mg daily doses. Based on safety outcomes, vaginal bleeding at the 100 mg dose, and vasomotor symptoms and cognitive outcomes at 12 weeks, a daily dose of 50 mg was considered preferable for a phase 2 efficacy trial.",2019,"Adverse events occurred in 16.7% (n = 4) placebo, 39.1% (n = 9) 50 mg/d, and 29.2% (n = 7) 100 ","['Seventy-one women were randomized to treatment; 70 were evaluated at 4 weeks; 12 were entered into the crossover study; 5 did not complete 12 weeks', 'menopausal symptoms', 'perimenopausal women aged 45 to 60, with intact uteri and ovaries, with at least one cognitive complaint, and one vasomotor-related symptom']","['estrogen receptor-β targeted phytoSERM formulation', 'phytoSERM with placebo', 'genistein, daidzein, and S-equol', 'placebo']","['Adverse events', 'safety and tolerability', 'Vaginal bleeding', 'safety outcomes, vaginal bleeding', 'cognition and vasomotor symptoms', 'vasomotor symptoms and cognitive outcomes']","[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C0057090', 'cui_str': 'diadzein'}, {'cui': 'C3892880', 'cui_str': '(R) - EQUOL'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2979982', 'cui_str': 'Vaginal Bleeding'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",71.0,0.611442,"Adverse events occurred in 16.7% (n = 4) placebo, 39.1% (n = 9) 50 mg/d, and 29.2% (n = 7) 100 ","[{'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Schneider', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'University of Arizona, Tucson, AZ.'}, {'ForeName': 'Liqin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Pharmacy, University of Kansas, Lawrence, KS.'}, {'ForeName': 'Adrian A', 'Initials': 'AA', 'LastName': 'Franke', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pawluczyk', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Roberta D', 'Initials': 'RD', 'LastName': 'Brinton', 'Affiliation': 'University of Arizona, Tucson, AZ.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001325']
3493,30865324,"Effects of the Strong Hearts, Healthy Communities Intervention on Functional Fitness of Rural Women.","PURPOSE


The purposes of these analyses were to determine whether Strong Hearts, Healthy Communities (SHHC), a multilevel, cardiovascular disease risk reduction program for overweight, sedentary rural women aged 40 or older, led to improved functional fitness, and if changes in fitness accounted for weight loss associated with program participation.
METHODS


Sixteen rural communities were randomized to receive the SHHC intervention or a control program. Both programs involved groups of 12-16 participants. The SHHC program met 1 hour twice a week for 24 weeks where participants engaged in aerobic exercise and progressive strength training. Program content addressed diet and social and environmental influences on heart-healthy behavior. The control group met 1 hour each month for 6 months, covering current dietary and physical activity recommendations. Objective measures of functional fitness included the 30-second arm curl, 30-second chair stand, and 2-minute step test. Self-reported functional fitness was measured by the Physical Functioning Subscale of the MOS Short Form-36 (SF-36 PF).
FINDINGS


The SHHC program was associated with increased strength and endurance, as represented by greater improvement in the chair stand and step test; and with increased physical function, as represented by the SF-36 PF. Adjustment for change in aerobic endurance, as measured by the step test, accounted for two-thirds of the intervention effect on weight loss at the end of the intervention.
CONCLUSIONS


SHHC participants experienced improved performance on objective measures of functional fitness and self-reported measures of physical function, and changes in weight were partially accounted for by changes in aerobic fitness.",2020,"The SHHC program was associated with increased strength and endurance, as represented by greater improvement in the chair stand and step test; and with increased physical function, as represented by the SF-36 PF.","['Rural Women', 'Strong Hearts, Healthy Communities (SHHC), a multilevel, cardiovascular disease risk reduction program for overweight, sedentary rural women aged 40 or older', 'Sixteen rural communities', 'heart-healthy behavior']","['aerobic exercise and progressive strength training', 'SHHC intervention or a control program', 'Strong Hearts, Healthy Communities Intervention']","['physical function', 'Self-reported functional fitness', 'weight loss', 'functional fitness and self-reported measures of physical function, and changes in weight', 'Physical Functioning Subscale of the MOS Short Form-36 (SF-36 PF', 'Functional Fitness', 'strength and endurance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",16.0,0.0149999,"The SHHC program was associated with increased strength and endurance, as represented by greater improvement in the chair stand and step test; and with increased physical function, as represented by the SF-36 PF.","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pullyblank', 'Affiliation': 'Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': 'Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'Montana State University, Bozeman, Montana.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': 'Hampshire College, Amherst, Massachusetts.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Cornell University, Ithaca, New York.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Marshall', 'Affiliation': 'Cornell University, Ithaca, New York.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': 'Montana State University Extension, Bozeman, Montana.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Cornell University, Ithaca, New York.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mebust', 'Affiliation': 'Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin', 'Affiliation': 'Cornell University, Ithaca, New York.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12361']
3494,30699301,Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention.,"BACKGROUND


Mass administration of azithromycin for trachoma control led to a sustained reduction in all-cause mortality among Ethiopian children. Whether the addition of azithromycin to the monthly sulfadoxine-pyrimethamine plus amodiaquine used for seasonal malaria chemoprevention could reduce mortality and morbidity among African children was unclear.
METHODS


We randomly assigned children 3 to 59 months of age, according to household, to receive either azithromycin or placebo, together with sulfadoxine-pyrimethamine plus amodiaquine, during the annual malaria-transmission season in Burkina Faso and Mali. The drug combinations were administered in four 3-day cycles, at monthly intervals, for three successive seasons. The primary end point was death or hospital admission for at least 24 hours that was not due to trauma or elective surgery. Data were recorded by means of active and passive surveillance.
RESULTS


In July 2014, a total of 19,578 children were randomly assigned to receive seasonal malaria chemoprevention plus either azithromycin (9735 children) or placebo (9843 children); each year, children who reached 5 years of age exited the trial and new children were enrolled. In the intention-to-treat analysis, the overall number of deaths and hospital admissions during three malaria-transmission seasons was 250 in the azithromycin group and 238 in the placebo group (events per 1000 child-years at risk, 24.8 vs. 23.5; incidence rate ratio, 1.1; 95% confidence interval [CI], 0.88 to 1.3). Results were similar in the per-protocol analysis. The following events occurred less frequently with azithromycin than with placebo: gastrointestinal infections (1647 vs. 1985 episodes; incidence rate ratio, 0.85; 95% CI, 0.79 to 0.91), upper respiratory tract infections (4893 vs. 5763 episodes; incidence rate ratio, 0.85; 95% CI, 0.81 to 0.90), and nonmalarial febrile illnesses (1122 vs. 1424 episodes; incidence rate ratio, 0.79; 95% CI, 0.73 to 0.87). The prevalence of malaria parasitemia and incidence of adverse events were similar in the two groups.
CONCLUSIONS


Among children in Burkina Faso and Mali, the addition of azithromycin to the antimalarial agents used for seasonal malaria chemoprevention did not result in a lower incidence of death or hospital admission that was not due to trauma or surgery than antimalarial agents plus placebo, although a lower disease burden was noted with azithromycin than with placebo. (Funded by the Joint Global Health Trials scheme; ClinicalTrials.gov number, NCT02211729.).",2019,"BACKGROUND


Mass administration of azithromycin for trachoma control led to a sustained reduction in all-cause mortality among Ethiopian children.","['African children', '9843 children); each year, children who reached 5 years of age exited the trial and new children were enrolled', 'Ethiopian children', '9735 children) or', 'In July 2014, a total of 19,578 children']","['sulfadoxine-pyrimethamine plus amodiaquine', 'placebo', 'Azithromycin', 'azithromycin', 'azithromycin or placebo, together with sulfadoxine-pyrimethamine plus amodiaquine', 'seasonal malaria chemoprevention plus either azithromycin']","['prevalence of malaria parasitemia and incidence of adverse events', 'overall number of deaths and hospital admissions', 'mortality and morbidity', 'nonmalarial febrile illnesses', 'upper respiratory tract infections', 'death or hospital admission']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0743841', 'cui_str': 'Febrile syndrome'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",19578.0,0.587293,"BACKGROUND


Mass administration of azithromycin for trachoma control led to a sustained reduction in all-cause mortality among Ethiopian children.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Yerbanga', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Abdourhamane', 'Initials': 'A', 'LastName': 'Traore', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Milligan', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Ogobara', 'Initials': 'O', 'LastName': 'Doumbo', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Jean-Bosco', 'Initials': 'JB', 'LastName': 'Ouedraogo', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine, London (D.C., M.C., I.K., P.M., B.G.); the Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali (A.D., I.S., M.D., A.B., A. Tapily, S.C., I.T., O.D.); and Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso (I.Z., F.N., S.Y., A. Traore, H.T., J.-B.O.).'}]",The New England journal of medicine,['10.1056/NEJMoa1811400']
3495,31314965,Effect of Universal Testing and Treatment on HIV Incidence - HPTN 071 (PopART).,"BACKGROUND


A universal testing and treatment strategy is a potential approach to reduce the incidence of human immunodeficiency virus (HIV) infection, yet previous trial results are inconsistent.
METHODS


In the HPTN 071 (PopART) community-randomized trial conducted from 2013 through 2018, we randomly assigned 21 communities in Zambia and South Africa (total population, approximately 1 million) to group A (combination prevention intervention with universal antiretroviral therapy [ART]), group B (the prevention intervention with ART provided according to local guidelines [universal since 2016]), or group C (standard care). The prevention intervention included home-based HIV testing delivered by community workers, who also supported linkage to HIV care and ART adherence. The primary outcome, HIV incidence between months 12 and 36, was measured in a population cohort of approximately 2000 randomly sampled adults (18 to 44 years of age) per community. Viral suppression (<400 copies of HIV RNA per milliliter) was assessed in all HIV-positive participants at 24 months.
RESULTS


The population cohort included 48,301 participants. Baseline HIV prevalence was 21% or 22% in each group. Between months 12 and 36, a total of 553 new HIV infections were observed during 39,702 person-years (1.4 per 100 person-years; women, 1.7; men, 0.8). The adjusted rate ratio for group A as compared with group C was 0.93 (95% confidence interval [CI], 0.74 to 1.18; P = 0.51) and for group B as compared with group C was 0.70 (95% CI, 0.55 to 0.88; P = 0.006). The percentage of HIV-positive participants with viral suppression at 24 months was 71.9% in group A, 67.5% in group B, and 60.2% in group C. The estimated percentage of HIV-positive adults in the community who were receiving ART at 36 months was 81% in group A and 80% in group B.
CONCLUSIONS


A combination prevention intervention with ART provided according to local guidelines resulted in a 30% lower incidence of HIV infection than standard care. The lack of effect with universal ART was unanticipated and not consistent with the data on viral suppression. In this trial setting, universal testing and treatment reduced the population-level incidence of HIV infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 071 [PopArt] ClinicalTrials.gov number, NCT01900977.).",2019,A combination prevention intervention with ART provided according to local guidelines resulted in a 30% lower incidence of HIV infection than standard care.,"['2000 randomly sampled adults (18 to 44 years of age) per community', 'population cohort included 48,301 participants', '2013 through 2018, we randomly assigned 21 communities in Zambia and South Africa (total population, approximately 1 million) to group']","['A (combination prevention intervention with universal antiretroviral therapy [ART]), group B (the prevention intervention with ART provided according to local guidelines [universal since 2016]), or group C (standard care', 'home-based HIV testing delivered by community workers, who also supported linkage to HIV care and ART adherence']","['HIV infection', 'percentage of HIV-positive participants with viral suppression', 'adjusted rate ratio', 'Baseline HIV prevalence', 'HIV incidence', 'Viral suppression', 'population-level incidence of HIV infection', 'HIV Incidence - HPTN 071 (PopART']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.335743,A combination prevention intervention with ART provided according to local guidelines resulted in a 30% lower incidence of HIV infection than standard care.,"[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Hayes', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Nomtha', 'Initials': 'N', 'LastName': 'Mandla', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Bwalya', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Sabapathy', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Blia', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Mwelwa', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Kosloff', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Anelet', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Skalland', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Wilson', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Emel', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Dunbar', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Musonda', 'Initials': 'M', 'LastName': 'Simwinga', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Nozizwe', 'Initials': 'N', 'LastName': 'Makola', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Ayana', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Griffith', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Deshmane Sista', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Sten H', 'Initials': 'SH', 'LastName': 'Vermund', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Wafaa', 'Initials': 'W', 'LastName': 'El-Sadr', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Burns', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hargreaves', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hauck', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Fraser', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Nulda', 'Initials': 'N', 'LastName': 'Beyers', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1814556']
3496,31075706,Improvement in anxiety and depression symptoms following cognitive behavior therapy for pediatric obsessive compulsive disorder.,"Pediatric obsessive-compulsive disorder (OCD) co-occurs frequently with other mental health conditions, adding to the burden of disease and complexity of treatment. Cognitive behavioral therapy (CBT) is efficacious for both OCD and two of its most common comorbid conditions, anxiety and depression. Therefore, treating OCD may yield secondary benefits for anxiety and depressive symptomatology. This study examined whether anxiety and/or depression symptoms declined over the course of OCD treatment and, if so, whether improvements were secondary to reductions in OCD severity, impairment, and/or global treatment response. The sample consisted of 137 youths who received 12 sessions of manualized CBT and were assessed by independent evaluators. Mixed models analysis indicated that youth-reported anxiety and depression symptoms decreased in a linear fashion over the course of CBT, however these changes were not linked to specific improvements in OCD severity or impairment but to global ratings of treatment response. Results indicate that for youth with OCD, CBT may offer benefit for secondary anxiety and depression symptoms distinct from changes in primary symptoms. Understanding the mechanisms underlying carryover in CBT techniques is important for furthering transdiagnostic and/or treatment-sequencing strategies to address co-occurring anxiety and depression symptoms in pediatric OCD.",2019,"Mixed models analysis indicated that youth-reported anxiety and depression symptoms decreased in a linear fashion over the course of CBT, however these changes were not linked to specific improvements in OCD severity or impairment but to global ratings of treatment response.","['137 youths who received', 'pediatric obsessive compulsive disorder']","['cognitive behavior therapy', '12 sessions of manualized CBT', 'Cognitive behavioral therapy (CBT']","['anxiety and depression symptoms', 'anxiety', 'OCD severity, impairment, and/or global treatment response', 'and/or depression symptoms']","[{'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",137.0,0.0294011,"Mixed models analysis indicated that youth-reported anxiety and depression symptoms decreased in a linear fashion over the course of CBT, however these changes were not linked to specific improvements in OCD severity or impairment but to global ratings of treatment response.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozenman', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA. Electronic address: mrozenman@mednet.ucla.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': ""O'Neill"", 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'R Lindsey', 'Initials': 'RL', 'LastName': 'Bergman', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}]",Psychiatry research,['10.1016/j.psychres.2019.04.021']
3497,31077251,Mapping the medical outcomes study HIV health survey (MOS-HIV) to the EuroQoL 5 Dimension (EQ-5D-3 L) utility index.,"BACKGROUND


Mapping of health-related quality-of-life measures to health utility values can facilitate cost-utility evaluation. Regression-based methods tend to lead to shrinkage of variance. This study aims to map the Medical Outcomes Study HIV Health Survey (MOS-HIV) to EuroQoL 5 Dimensions (EQ-5D-3 L) utility index, and to characterize the performance of three mapping methods, including ordinary least squares (OLS), equi-percentile method (EPM), and a recently proposed method called Mean Rank Method (MRM).
METHODS


This is a secondary analysis of data from a randomized HIV treatment trial. Baseline data from 421 participants were used to develop mapping functions. Follow-up data from 236 participants was used to validate the mapping functions.
RESULTS


In the training dataset, MRM and OLS, but not EPM, reproduced the observed mean utility (0.731). MRM, OLS and EPM under-estimated the standard deviation by 0.3, 26.6 and 1.7%, respectively. MRM had the lowest mean absolute error (0.143) and highest intraclass correlation coefficient (0.723) with the observed utility values, whereas OLS had the lowest mean squared error (0.038) and highest R-squared (0.542). Regressing the MRM- and OLS-mapped utility values upon body mass index and log-viral load gave covariate associations comparable to those estimated from the observed utility data (all P > 0.10). EPM did not achieve this property. Findings from the validation data were similar.
CONCLUSIONS


Functions are available for mapping the MOS-HIV to the EQ-5D-3 L utility values. MRM and OLS were comparable in terms of agreement with the observed utility values at the individual level. MRM had better performance at the group level in terms of describing the utility distribution.
TRIAL REGISTRATION


NCT00988039 . Registered 30 September 2009.",2019,"MRM had the lowest mean absolute error (0.143) and highest intraclass correlation coefficient (0.723) with the observed utility values, whereas OLS had the lowest mean squared error (0.038) and highest R-squared (0.542).","['421 participants', '236 participants']","['MRM', 'EPM']","['MRM, OLS and EPM under-estimated the standard deviation', 'MRM and OLS']",[],[],"[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",421.0,0.0683714,"MRM had the lowest mean absolute error (0.143) and highest intraclass correlation coefficient (0.723) with the observed utility values, whereas OLS had the lowest mean squared error (0.038) and highest R-squared (0.542).","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Center, Singapore, Singapore.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Paton', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Program in Health Services & System Research and Center for Quantitative Medicine, Duke-NUS Medical School, Level 6, Academia, Singapore, Singapore. yinbun.cheung@duke-nus.edu.sg.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Health and quality of life outcomes,['10.1186/s12955-019-1135-8']
3498,30990855,"The reflective component of the Mellow Bumps parenting intervention: Implementation, engagement and mechanisms of change.","Understanding why parenting programmes work or do not work, and for whom, is crucial for development of more effective parenting interventions. In this paper we focus on a specific component of Mellow Bumps: reflection on one's own childhood/past/life. We explore how this component was implemented, how participants engaged with it, the facilitating and constraining factors shaping this, whether and how it appeared to work, or not, and for whom. The paper analyses data from the Process Evaluation of the Trial of Healthy Relationships Initiatives for the Very Early years, which is evaluating two antenatal interventions delivered to vulnerable women, one of which is Mellow Bumps. Data were collected from January 2014 to June 2018 for 28 groups, 108 participants and 24 facilitators in a comprehensive and rigorous Process Evaluation designed to complement the Outcome Evaluation. Data were gathered at various time points using multiple methods, and were synthesised to triangulate findings. The reflective component was implemented with fidelity and participants engaged with it to varying degrees, dependent largely on the coherence of the group. Patchy attendance compromised the coherence of some groups, with the development of rapport, which is key to delivering reflective exercises, more difficult when group composition varied from week to week. Where there was a coherent group, powerful mechanisms of change, leading to stress reduction, included: relief through unburdening, empowerment through support given and received, reduced isolation through sharing anxieties, and control through self-care advice. A minority of highly vulnerable mothers seemed not to benefit from the reflective exercises and were marginalised within their groups. In order to minimise potential harmful effects of such exercises, allocation of participants to groups should strive to maximise group homogeneity. More research is needed to explore how very vulnerable parents can be supported in attending parenting interventions from start to finish.",2019,"Patchy attendance compromised the coherence of some groups, with the development of rapport, which is key to delivering reflective exercises, more difficult when group composition varied from week to week.","['Data were collected from January 2014 to June 2018 for 28 groups, 108 participants and 24 facilitators in a comprehensive and rigorous Process Evaluation designed to complement the Outcome Evaluation']",[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009498', 'cui_str': 'Complement System Proteins'}]",[],[],108.0,0.0246722,"Patchy attendance compromised the coherence of some groups, with the development of rapport, which is key to delivering reflective exercises, more difficult when group composition varied from week to week.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Buston', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Rosaleen', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'Glasgow Caledonian University, Psychology, Social Work and Allied Health Professionals, School of Health and Life Sciences, Glasgow, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wight', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Henderson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0215461']
3499,30796818,Safety and Immunogenicity of a 2-Dose Heterologous Vaccination Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Uganda and Tanzania.,"BACKGROUND


Ebola vaccine development was accelerated in response to the 2014 Ebola virus infection outbreak. This phase 1 study (VAC52150EBL1004) assessed safety, tolerability, and immunogenicity of heterologous 2-dose Ad26.ZEBOV, MVA-BN-Filo vaccination regimens in the Lake Victoria Basin of Tanzania and Uganda in mid-level altitude, malaria-endemic settings.
METHODS


Healthy volunteers aged 18-50 years from Tanzania (n = 25) and Uganda (n = 47) were randomized to receive placebo or active vaccination with Ad26.ZEBOV or MVA-BN-Filo (first vaccination), followed by MVA-BN-Filo or Ad26.ZEBOV (second vaccination) dose 2, respectively, with intervals of 28 or 56 days.
RESULTS


Seventy-two adults were randomized to receive vaccine (n = 60) or placebo (n = 12). No vaccine-related serious adverse events were reported. The most frequent solicited local and systemic adverse events were injection site pain (frequency, 70%, 66%, and 42% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively) and headache (57%, 56%, and 46%, respectively). Adverse event patterns were similar among regimens. Twenty-one days after dose 2, 100% of volunteers demonstrated binding antibody responses against Ebola virus glycoprotein, and 87%-100% demonstrated neutralizing antibody responses. Ad26.ZEBOV dose 1 vaccination induced more-robust initial binding antibody and cellular responses than MVA-BN-Filo dose 1 vaccination.
CONCLUSIONS


Heterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filo against Ebola virus is well tolerated and immunogenic in healthy volunteers.
CLINICAL TRIALS REGISTRATION


NCT02376400.",2019,"dose 1 vaccination induced more-robust initial binding antibody and cellular responses than MVA-BN-Filo dose 1 vaccination.
","['Seventy-two adults', 'Lake Victoria Basin of Tanzania and Uganda in mid-level altitude, malaria-endemic settings', 'Healthy volunteers aged 18-50 years from Tanzania (n = 25) and Uganda (n = 47', 'healthy volunteers', '2014 Ebola virus infection outbreak']","['placebo', 'heterologous 2-dose Ad26.ZEBOV, MVA-BN-Filo vaccination regimens', 'Ad26.ZEBOV', 'vaccine', '2-Dose Heterologous Vaccination Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines', 'placebo or active vaccination with Ad26.ZEBOV or MVA-BN-Filo (first vaccination), followed by MVA-BN-Filo or Ad26.ZEBOV']","['Safety and Immunogenicity', 'headache', 'binding antibody responses against Ebola virus glycoprotein', 'safety, tolerability, and immunogenicity', 'neutralizing antibody responses']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0179226', 'cui_str': 'Basin, device (physical object)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282687', 'cui_str': 'Ebola Virus Disease'}, {'cui': 'C0220888', 'cui_str': 'outbreaks'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0949892', 'cui_str': 'Ebola Virus'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",47.0,0.144961,"dose 1 vaccination induced more-robust initial binding antibody and cellular responses than MVA-BN-Filo dose 1 vaccination.
","[{'ForeName': 'Zacchaeus', 'Initials': 'Z', 'LastName': 'Anywaine', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Whitworth', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Praygod', 'Affiliation': 'Mwanza Research Center, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Georgi', 'Initials': 'G', 'LastName': 'Shukarev', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Manno', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Grosskurth', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kalluvya', 'Affiliation': 'Bugando Medical Center, Mwanza, Tanzania.'}, {'ForeName': 'Viki', 'Initials': 'V', 'LastName': 'Bockstal', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Dickson', 'Initials': 'D', 'LastName': 'Anumendem', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luhn', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Watson-Jones', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz070']
3500,30797989,"Mental imagery as a ""motivational amplifier"" to promote activities.","Facilitating engagement in rewarding activities is a key treatment target in depression. Mental imagery can increase engagement in planned behaviours, potentially due to its special role in representing emotionally salient experiences. The present study tested the hypothesis that mental imagery promotes motivation and engagement when planning pleasant and rewarding activities. Participants were recruited from a community volunteer panel (N = 72). They self-nominated six activities to complete over the following week, and were randomized to either: a) a single-session Motivational Imagery condition (N = 24); b) an Activity Reminder control condition (N = 24); or c) a No-Reminder control condition (N = 24). As predicted, relative to control groups, the Motivational Imagery group reported higher levels of motivation, anticipated pleasure, and anticipated reward for the planned activities. The Motivational Imagery group also completed significantly more activities than the Activity Reminder group, but not more than the No-Reminder group. Relevance of results to behavioural activation approaches for depression are discussed.",2019,"The Motivational Imagery group also completed significantly more activities than the Activity Reminder group, but not more than the No-Reminder group.",['Participants were recruited from a community volunteer panel (N\u202f=\u202f72'],['Activity Reminder control condition (N\u202f=\u202f24); or c) a No-Reminder control condition'],"['activities', 'levels of motivation, anticipated pleasure, and anticipated reward for the planned activities']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]",,0.0289745,"The Motivational Imagery group also completed significantly more activities than the Activity Reminder group, but not more than the No-Reminder group.","[{'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Renner', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Freiburg, Germany; MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK. Electronic address: fritz.renner@psychologie.uni-freiburg.de.'}, {'ForeName': 'Fionnuala C', 'Initials': 'FC', 'LastName': 'Murphy', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Ji', 'Affiliation': 'School of Psychological Science, University of Western Australia, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Manly', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK; Department of Psychology, Uppsala University, Sweden.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.02.002']
3501,30983166,"A Multicenter, Randomized, Placebo-Controlled Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients With Rheumatoid Arthritis.","OBJECTIVE


Rheumatoid arthritis (RA) is associated with increased cardiovascular event (CVE) risk. The impact of statins in RA is not established. We assessed whether atorvastatin is superior to placebo for the primary prevention of CVEs in RA patients.
METHODS


A randomized, double-blind, placebo-controlled trial was designed to detect a 32% CVE risk reduction based on an estimated 1.6% per annum event rate with 80% power at P < 0.05. RA patients age >50 years or with a disease duration of >10 years who did not have clinical atherosclerosis, diabetes, or myopathy received atorvastatin 40 mg daily or matching placebo. The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, transient ischemic attack, or any arterial revascularization. Secondary and tertiary end points included plasma lipids and safety.
RESULTS


A total of 3,002 patients (mean age 61 years; 74% female) were followed up for a median of 2.51 years (interquartile range [IQR] 1.90, 3.49 years) (7,827 patient-years). The study was terminated early due to a lower than expected event rate (0.70% per annum). Of the 1,504 patients receiving atorvastatin, 24 (1.6%) experienced a primary end point, compared with 36 (2.4%) of the 1,498 receiving placebo (hazard ratio [HR] 0.66 [95% confidence interval (95% CI) 0.39, 1.11]; P = 0.115 and adjusted HR 0.60 [95% CI 0.32, 1.15]; P = 0.127). At trial end, patients receiving atorvastatin had a mean ± SD low-density lipoprotein (LDL) cholesterol level 0.77 ± 0.04 mmoles/liter lower than those receiving placebo (P < 0.0001). C-reactive protein level was also significantly lower in the atorvastatin group than the placebo group (median 2.59 mg/liter [IQR 0.94, 6.08] versus 3.60 mg/liter [IQR 1.47, 7.49]; P < 0.0001). CVE risk reduction per mmole/liter reduction in LDL cholesterol was 42% (95% CI -14%, 70%). The rates of adverse events in the atorvastatin group (n = 298 [19.8%]) and placebo group (n = 292 [19.5%]) were similar.
CONCLUSION


Atorvastatin 40 mg daily is safe and results in a significantly greater reduction of LDL cholesterol level than placebo in patients with RA. The 34% CVE risk reduction is consistent with the Cholesterol Treatment Trialists' Collaboration meta-analysis of statin effects in other populations.",2019,Atorvastatin 40mg daily was safe and resulted in significantly greater reduction of LDLc than placebo in patients with RA.,"['Patients aged >50 years or with RA duration >10 years; without clinical atherosclerosis, diabetes, or myopathy', 'patients with rheumatoid arthritis (TRACE RA', '3002 patients (mean age 61 years, 74% female', 'patients with RA']","['atorvastatin', 'atorvastatin 40mg daily or matching placebo', 'Atorvastatin', 'placebo']","['Adverse events', 'LDL-cholesterol', 'CVE risk reduction per mmol/L LDLc reduction', 'cardiovascular events', 'plasma lipids and safety', 'LDLc', 'composite of cardiovascular death, myocardial infarction, stroke, transient ischemic attack, or any arterial revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0026848', 'cui_str': 'Muscle Disorders'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0442822', 'cui_str': 'Trace (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",,0.649814,Atorvastatin 40mg daily was safe and resulted in significantly greater reduction of LDLc than placebo in patients with RA.,"[{'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Kitas', 'Affiliation': 'Dudley Group NHS Foundation Trust, Russells Hall Hospital, Stourbridge, UK, and Research UK Centre for Epidemiology, Manchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'University of Glasgow, Glasgow, UK, and Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, UK.'}, {'ForeName': 'Jill J F', 'Initials': 'JJF', 'LastName': 'Belch', 'Affiliation': 'University of Dundee and Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Deborah P M', 'Initials': 'DPM', 'LastName': 'Symmons', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, University of Manchester, and NIHR Manchester Biomedical Research Center, Manchester NHS Foundation Trust, Manchester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.40892']
3502,30986795,Self-Collection of Vaginal Swabs Among Adolescent Girls in a School-Setting in East Africa.,"BACKGROUND


Few studies have evaluated the acceptability of self-collected vaginal swabs among young women in sub-Saharan Africa, including in school settings. We evaluated the acceptability of 2 conditions for the self-collection of swabs in secondary schools in Entebbe, Uganda.
METHODS


Assenting girls with parental consent from 3 secondary schools were provided instructions for sampling, and randomly allocated to self-collection of vaginal swabs with or without nurse assistance to help with correct placement of the swab. Swabs were tested for bacterial vaginosis by Gram stain. Participants were followed up after 1 to 2 days and 1 to 2 weeks and invited for a qualitative interview.
RESULTS


Overall 96 girls were enrolled (median age, 16 years; interquartile range, 15-17 years). At the first follow-up visit, participants in both arms reported that instructions for sample collection were easy to understand, and they felt comfortable with self-collection. Girls in the nurse assistance arm reported feeling less relaxed (27% vs. 50%, P = 0.02) than those in the arm without nurse assistance, but more confident that they collected the sample correctly (96% vs. 83%, P = 0.04). About half (47%) of participants agreed that self-sampling was painful, but almost all (94%) would participate in a similar study again. Qualitative data showed that participants preferred self-collection without nurse assistance to preserve privacy. Bacterial vaginosis prevalence was 14% (95% confidence interval, 8-22).
CONCLUSIONS


In this setting, self-collection of vaginal swabs in secondary schools was acceptable and feasible, and girls preferred self-collection without nurse assistance. Self-collection of swabs is an important tool for the detection, treatment and control of reproductive tract infections in girls and young women.",2019,"Girls in the nurse assistance arm reported feeling less relaxed (27% vs. 50%, P = 0.02) than those in the arm without nurse assistance, but more confident that they collected the sample correctly (96% vs. 83%, P = 0.04).","['young women in sub-Saharan Africa, including in school settings', 'Adolescent Girls in a School-Setting in East Africa', 'Overall 96 girls were enrolled (median age, 16 years; interquartile range, 15-17 years', 'girls and young women', 'Assenting girls with parental consent from 3 secondary schools']",['self-collection of vaginal swabs with or without nurse assistance to help with correct placement of the swab'],"['Bacterial vaginosis prevalence', 'Self-Collection of Vaginal Swabs']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001741', 'cui_str': 'East Africa'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab (specimen)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]","[{'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab (specimen)'}]",96.0,0.0398205,"Girls in the nurse assistance arm reported feeling less relaxed (27% vs. 50%, P = 0.02) than those in the arm without nurse assistance, but more confident that they collected the sample correctly (96% vs. 83%, P = 0.04).","[{'ForeName': 'Suzanna C', 'Initials': 'SC', 'LastName': 'Francis', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Miiro', 'Affiliation': 'Uganda Virus Research Institute.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Nakuya', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Rwamahe', 'Initials': 'R', 'LastName': 'Rutakumwa', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Nakiyingi-Miiro', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Nabaggala', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Saidat', 'Initials': 'S', 'LastName': 'Musoke', 'Affiliation': 'Uganda Virus Research Institute.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Namakula', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Tanton', 'Affiliation': ''}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Torondel', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ross', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000000990']
3503,30762468,Deleterious Effects of Cold Air Inhalation on Coronary Physiological Indices in Patients With Obstructive Coronary Artery Disease.,"Background Cold air inhalation during exercise increases cardiac mortality, but the pathophysiology is unclear. During cold and exercise, dual-sensor intracoronary wires measured coronary microvascular resistance ( MVR ) and blood flow velocity ( CBF ), and cardiac magnetic resonance measured subendocardial perfusion. Methods and Results Forty-two patients (62±9 years) undergoing cardiac catheterization, 32 with obstructive coronary stenoses and 10 without, performed either (1) 5 minutes of cold air inhalation (5°F) or (2) two 5-minute supine-cycling periods: 1 at room temperature and 1 during cold air inhalation (5°F) (randomized order). We compared rest and peak stress MVR , CBF , and subendocardial perfusion measurements. In patients with unobstructed coronary arteries (n=10), cold air inhalation at rest decreased MVR by 6% ( P=0.41), increasing CBF by 20% ( P<0.01). However, in patients with obstructive stenoses (n=10), cold air inhalation at rest increased MVR by 17% ( P<0.01), reducing CBF by 3% ( P=0.85). Consequently, in patients with obstructive stenoses undergoing the cardiac magnetic resonance protocol (n=10), cold air inhalation reduced subendocardial perfusion ( P<0.05). Only patients with obstructive stenoses performed this protocol (n=12). Cycling at room temperature decreased MVR by 29% ( P<0.001) and increased CBF by 61% ( P<0.001). However, cold air inhalation during cycling blunted these adaptations in MVR ( P=0.12) and CBF ( P<0.05), an effect attributable to defective early diastolic CBF acceleration ( P<0.05) and associated with greater ST -segment depression ( P<0.05). Conclusions In patients with obstructive coronary stenoses, cold air inhalation causes deleterious changes in MVR and CBF . These diminish or abolish the normal adaptations during exertion that ordinarily match myocardial blood supply to demand.",2018,Cycling at room temperature decreased MVR by 29% ( P<0.001) and increased CBF by 61% ( P<0.001).,"['Patients With Obstructive Coronary Artery Disease', 'Only patients with obstructive stenoses performed this protocol (n=12', 'Forty-two patients (62±9\xa0years) undergoing cardiac catheterization, 32 with obstructive coronary stenoses and 10 without, performed either (1) 5 minutes of', 'patients with obstructive stenoses undergoing the', 'patients with obstructive coronary stenoses']","['cold air inhalation (5°F) or (2) two 5-minute supine-cycling periods: 1 at room temperature and 1 during cold air inhalation', 'Cold Air Inhalation', 'cardiac magnetic resonance protocol (n=10), cold air inhalation reduced subendocardial perfusion']","['cold air inhalation at rest decreased MVR', 'rest and peak stress MVR , CBF , and subendocardial perfusion measurements', 'Coronary Physiological Indices', 'defective early diastolic CBF acceleration', 'MVR and CBF ', 'coronary microvascular resistance ( MVR ) and blood flow velocity ( CBF ), and cardiac magnetic resonance measured subendocardial perfusion', 'cardiac mortality', 'MVR', 'CBF', 'cold air inhalation at rest increased MVR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0450029', 'cui_str': 'Cold air (substance)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0450029', 'cui_str': 'Cold air (substance)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",42.0,0.0235895,Cycling at room temperature decreased MVR by 29% ( P<0.001) and increased CBF by 61% ( P<0.001).,"[{'ForeName': 'Rupert P', 'Initials': 'RP', 'LastName': 'Williams', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Kaleab N', 'Initials': 'KN', 'LastName': 'Asrress', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lumley', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Satpal', 'Initials': 'S', 'LastName': 'Arri', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Patterson', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Ellis', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Manou-Stathopoulou', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Macfarlane', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Shruthi', 'Initials': 'S', 'LastName': 'Chandran', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Kostantinos', 'Initials': 'K', 'LastName': 'Moschonas', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Oakeshott', 'Affiliation': ""2 Population Health Research Institute St George's University of London United Kingdom.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Lockie', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Chiribiri', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Clapp', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Divaka', 'Initials': 'D', 'LastName': 'Perera', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Plein', 'Affiliation': '3 Leeds University Leeds Teaching Hospitals NHS Trust Leeds United Kingdom.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Marber', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Redwood', 'Affiliation': ""1 Cardiovascular Division Rayne Institute St Thomas' Hospital King's College London London United Kingdom.""}]",Journal of the American Heart Association,['10.1161/JAHA.118.008837']
3504,32024852,The gender dependent influence of sodium bicarbonate supplementation on anaerobic power and specific performance in female and male wrestlers.,"The aim of this study was the assessment of progressive low-dose sodium bicarbonate (NaHCO 3 ) supplementation on the anaerobic indices in two bouts of Wingate tests (WT) separated by wrestling-specific performance test and assessing the gender differences in response. Fifty-one (18 F) wrestlers completed a randomized trial of either a NaHCO 3  (up to 100 mg·kg -1 ) or a placebo for 10 days. Before and after treatment, athletes completed an exercise protocol that comprised, in sequence, the first WT 1 , dummy throw test (DT), and second WT 2 . The number of completed throws increased significantly in males from 19.3 ± 2.6 NaHCO 3pre  to 21.7 ± 2.9 NaHCO 3post . ΔWT 2 -WT 1  improved particularly in the midsection of 30-s WT on NaHCO 3 . However, no significant differences were found in peak power (PP), power drop (PD) and average power (AP) (analyzed separately for each WT), and ΔWT 2 -WT 1  in PP and PD. Interaction with gender was significant for AP, PP and PD, every second of WT 1  and WT 2 , as well as DT test. In conclusion, our study suggests that the response to NaHCO 3  may be gender-specific and progressive low-dose NaHCO 3  supplementation allows the advantageous strengthening of wrestling-specific performance in males. It can also lead to maintenance of high anaerobic power mainly in the midsection of the 30-s Wingate test.",2020,"Interaction with gender was significant for AP, PP and PD, every second of WT 1  and WT 2 , as well as DT test.","['Fifty-one (18\u2009F) wrestlers', 'female and male wrestlers']","['NaHCO', 'placebo', 'sodium bicarbonate (NaHCO 3 ) supplementation', 'sodium bicarbonate supplementation']","['peak power (PP), power drop (PD) and average power (AP', 'anaerobic power and specific performance']","[{'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.0477219,"Interaction with gender was significant for AP, PP and PD, every second of WT 1  and WT 2 , as well as DT test.","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Durkalec-Michalski', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, 60-624, Poland. durkmich@up.poznan.pl.'}, {'ForeName': 'Emilia E', 'Initials': 'EE', 'LastName': 'Zawieja', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, 60-624, Poland.'}, {'ForeName': 'Bogna E', 'Initials': 'BE', 'LastName': 'Zawieja', 'Affiliation': 'Department of Mathematical and Statistical Methods, Poznań University of Life Sciences, Poznań, 60-637, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Michałowska', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, 60-624, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Podgórski', 'Affiliation': 'Department od Physiology and Biochemistry, Poznań University of Physical Education, Poznań, 61-871, Poland.'}]",Scientific reports,['10.1038/s41598-020-57590-x']
3505,30302577,Enhancing Outcomes of Low-Intensity Parenting Groups Through Sufficient Exemplar Training: A Randomized Control Trial.,"Low-intensity parenting groups, such as the Triple P-Positive Parenting Program Discussion Groups, appear to be a cost-effective intervention for child conduct problems. Several studies evaluating a Triple P Discussion Group on disobedience found promising results for improving child and parent outcomes. However, a sufficient exemplar training approach that incorporates generalization promotion strategies may assist parents to more flexibly apply positive parenting principles to a broader range of child target behaviors and settings, leading to greater change. We compared the effects of sufficient exemplar training to an existing narrowly focused low-intensity intervention. Participants were 78 families with a 5-8 year-old child. Sufficient exemplar training resulted in more robust changes in child behavior and superior outcomes for mothers on measures of parenting behavior, parenting self-efficacy, mental health, and perceptions of partner support at post-intervention and 6-month follow-up. These results indicate that teaching sufficient exemplars may promote generalization leading to enhanced intervention outcomes.",2019,"Sufficient exemplar training resulted in more robust changes in child behavior and superior outcomes for mothers on measures of parenting behavior, parenting self-efficacy, mental health, and perceptions of partner support at post-intervention and 6-month follow-up.",['Participants were 78 families with a 5-8 year-old child'],"['Low-Intensity Parenting Groups Through Sufficient Exemplar Training', 'sufficient exemplar training']","['child behavior and superior outcomes', 'parenting behavior, parenting self-efficacy, mental health, and perceptions of partner support']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",78.0,0.0220108,"Sufficient exemplar training resulted in more robust changes in child behavior and superior outcomes for mothers on measures of parenting behavior, parenting self-efficacy, mental health, and perceptions of partner support at post-intervention and 6-month follow-up.","[{'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Palmer', 'Affiliation': 'Faculty of Education and Social Work, School of Learning, Development and Professional Practice, The University of Auckland, Symonds St, Private Bag 92601, Auckland, 1142, New Zealand. melanie.l.palmer@gmail.com.'}, {'ForeName': 'Louise J', 'Initials': 'LJ', 'LastName': 'Keown', 'Affiliation': 'Faculty of Education and Social Work, School of Learning, Development and Professional Practice, The University of Auckland, Symonds St, Private Bag 92601, Auckland, 1142, New Zealand.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sanders', 'Affiliation': 'Parenting and Family Support Centre, The University of Queensland, Brisbane, QLD, 4072, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Henderson', 'Affiliation': 'Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow, G2 3QB, UK.'}]",Child psychiatry and human development,['10.1007/s10578-018-0847-z']
3506,30865917,"Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life.","BACKGROUND


Oral therapies are increasingly common in oncology care. However, data are lacking regarding the physical and psychologic symptoms patients experience, or how these factors relate to medication adherence and quality of life (QoL).
MATERIALS AND METHODS


From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center. Patients completed baseline assessments of adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment. Relationships among these factors were examined using Pearson product-moment correlations and multivariable linear regression.
RESULTS


At baseline, the mean electronic pill cap adherence rate showed that patients took 85.57% of their oral therapy. The most commonly reported cancer-related symptoms were fatigue (88.60%), drowsiness (76.50%), disturbed sleep (68.20%), memory problems (63.10%), and emotional distress (60.80%). Patients who reported greater cancer-related symptom severity had lower adherence (r= -0.20). In a multivariable regression, greater depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction with clinicians and treatment, and higher symptom burden were associated with worse QoL (F[10, 146]=50.53; adjusted R2=0.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
CONCLUSIONS


Patients prescribed oral therapies struggle with adherence, and cancer-related symptom burden is high and related to worse adherence and QoL. Given perceptions that oral therapies are less impairing, these data underscore the strong need to address adherence issues, symptom burden, and QoL for these patients.",2019,"Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
","['From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center']",['Oral Chemotherapy'],"['Anxiety symptoms', 'Adherence, Symptoms, and Quality of Life', 'mean electronic pill cap adherence rate', 'memory problems', 'emotional distress', 'depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction', 'drowsiness', 'adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment', 'disturbed sleep', 'medication adherence and quality of life (QoL']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0419073', 'cui_str': 'Oral chemotherapy (procedure)'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037438'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",181.0,0.10383,"Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Ream', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pensak', 'Affiliation': 'Anschutz Medical Campus, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Nisotel', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Fishbein', 'Affiliation': 'University of Colorado at Boulder, Boulder, Colorado.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'MacDonald', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Buzaglo', 'Affiliation': 'Cancer Support Community, Washington, DC.'}, {'ForeName': 'Inga T', 'Initials': 'IT', 'LastName': 'Lennes', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'University of Miami, Miami, Florida; and.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7098']
3507,29688915,"Clinical and Microbiological Effect of a Multispecies Probiotic Supplementation in Celiac Patients With Persistent IBS-type Symptoms: A Randomized, Double-Blind, Placebo-controlled, Multicenter Trial.","GOALS


The goals of this study were to evaluate the efficacy and safety of a probiotic mixture in patients with celiac disease (CD) with irritable bowel syndrome (IBS)-type symptoms despite a strict gluten-free diet (GFD).
BACKGROUND


About 30% of patients with CD adherent to a GFD suffer from IBS-type symptoms; a possible cause resides in the imbalances of the intestinal microbiota in CD. Probiotics may represent a potential treatment.
STUDY


CD patients with IBS-type symptoms entered a prospective, double-blind, randomized placebo-controlled study. A 6-week treatment period was preceded by a 2-week run-in and followed by a 6-week follow-up phase. Clinical data were monitored throughout the study by validated questionnaires: IBS Severity Scoring System (IBS-SSS); Gastrointestinal Symptom Rating Scale (GSRS); Bristol Stool Form Scale (BSFS); and IBS Quality of Life Questionnaire (IBS-QOL). The fecal microbiota were assayed using plate counts and 16S rRNA gene-based analysis.
RESULTS


In total, 109 patients were randomized to probiotics (n=54) or placebo (n=55). IBS-SSS and GSRS decreased significantly in probiotics, as compared with placebo [(-15.9%±14.8% vs. 8.2%±25.9%; P<0.001) and (-19.8%±16.6% vs. 12.9%±31.6%; P<0.001)], respectively. Treatment success was significantly higher in patients receiving probiotics, as compared with placebo (15.3% vs. 3.8%; P<0.04). Presumptive lactic acid bacteria, Staphylococcus and Bifidobacterium, increased in patients receiving probiotic treatment. No adverse events were reported.
CONCLUSIONS


A 6-week probiotic treatment is effective in improving the severity of IBS-type symptoms, in CD patients on strict GFD, and is associated with a modification of gut microbiota, characterized by an increase of bifidobacteria.",2019,"Treatment success was significantly higher in patients receiving probiotics, as compared with placebo (15.3% vs. 3.8%; P<0.04).","['patients with celiac disease (CD) with irritable bowel syndrome (IBS)-type symptoms despite a strict gluten-free diet (GFD', 'Celiac Patients With Persistent IBS-type Symptoms', 'CD patients with IBS-type symptoms', '109 patients were randomized to probiotics (n=54) or', 'patients receiving probiotic treatment']","['Placebo', 'Multispecies Probiotic Supplementation', 'probiotic mixture', 'placebo']","['Treatment success', 'IBS-SSS and GSRS', 'adverse events', 'efficacy and safety', 'questionnaires: IBS Severity Scoring System (IBS-SSS); Gastrointestinal Symptom Rating Scale (GSRS); Bristol Stool Form Scale (BSFS); and IBS Quality of Life Questionnaire (IBS-QOL', 'fecal microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0034380'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",109.0,0.21114,"Treatment success was significantly higher in patients receiving probiotics, as compared with placebo (15.3% vs. 3.8%; P<0.04).","[{'ForeName': 'Ruggiero', 'Initials': 'R', 'LastName': 'Francavilla', 'Affiliation': 'Department of Interdisciplinary Medicine.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Piccolo', 'Affiliation': 'Department of Soil, Plant and Food Science.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Francavilla', 'Affiliation': 'IRCCS ""Saverio De Bellis,"" Castellana Grotte.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Polimeno', 'Affiliation': 'Department of Interdisciplinary Medicine.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Gastroenterology Unit, PO Centrale Taranto, Taranto.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Cristofori', 'Affiliation': 'Department of Interdisciplinary Medicine.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Castellaneta', 'Affiliation': 'Department of Pediatrics, PO San Paolo, Bari.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Department of Emergency and Organ Transplantation, University of Bari Aldo Moro.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Indrio', 'Affiliation': 'Department of Interdisciplinary Medicine.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gobbetti', 'Affiliation': 'Faculty of Science and Technology, Piazza Università, Free University of Bozen, Bolzano, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Angelis', 'Affiliation': 'Department of Soil, Plant and Food Science.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001023']
3508,30798568,The role of Vitamin E - Selenium - Folic Acid Supplementation in Improving Sperm Parameters After Varicocelectomy: A Randomized Clinical Trial.,"PURPOSE


In this study, we aimed to evaluate the effects of antioxidants including Vitamin E-Selenium-Folic acid (Vit E -Se- FA) on semen parameters following varicocelectomy (VCT).
MATERIALS AND METHODS


Sixty patients from 64 infertile male patients diagnosed with varicocele (VC) who un-derwent sub-inguinal VCT were included in the study. Following sub-inguinal VCT, the patients were randomized into two groups: 30 receiving Vit E-Se-FA supplementation for six months, and 30 as the control group with supplemental treatment. The post-operative semen parameters of Vit E-Se-FA receiving group were compared with control group at the end of experiment. The sperm count, percentage of motile and abnormal sperms were considered.
RESULTS


There were statistically significant differences in terms of count (P = .031) and motility (P = .01) of sperm after six months of receiving Vit E-Se-FA supplementation comparing with control group.
CONCLUSION


Vit E-Se-FA supplementation can improve sperm parameters (count and motility of sperm) after VCT.",2019,"There were statistically significant increasing in terms of count (P=.031) and motility (P=.01) of sperm after six months of receiving Vit E-Se-FA supplementation comparing with control group.
",['Sixty from 64 infertile male patients diagnosed with varicocele (VC) and underwent sub-inguinal VCT were included in the study'],"['varicocelectomy (VCT', '30 receiving Vit E-Se-FA supplementation', 'Vit E-Se-FA', 'antioxidants including Vitamin E-Selenium-Folic acid (Vit E -Se- FA', 'Vit E-Se-FA supplementation', 'varicocelectomy', 'Vitamin E - Selenium - Folic acid supplementation']","['sperm parameters (count and motility of sperm', 'count (P=.031) and motility', 'sperm count, percentage of motile and abnormal sperms']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0194985', 'cui_str': 'Excision of varicocele (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}]","[{'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0037842', 'cui_str': 'Sperm Count'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}]",64.0,0.0280862,"There were statistically significant increasing in terms of count (P=.031) and motility (P=.01) of sperm after six months of receiving Vit E-Se-FA supplementation comparing with control group.
","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ardestani Zadeh', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran. ardestani_a@yahoo.com.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Naim Sadat', 'Initials': 'NS', 'LastName': 'Kia', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Heshmati', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Seyed Nilofar', 'Initials': 'SN', 'LastName': 'Amirkhalili', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4653']
3509,30552112,FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer.,"On December 20, 2017, the FDA granted regular approval to pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) at high risk of recurrence. Approval was based on data from the APHINITY trial, which randomized patients to receive pertuzumab or placebo in combination with trastuzumab and chemotherapy. After 45.4-month median follow-up, the proportion of invasive disease-free survival (IDFS) events in the intent-to-treat population was 7.1% ( n  = 171) in the pertuzumab arm and 8.7% ( n  = 210) for placebo [hazard ratio (HR), 0.82; 95% confidence interval (CI), 0.67-1.00;  P  = 0.047]. The proportion of IDFS events in patients with hormone receptor-negative disease was 8.2% ( n  = 71) and 10.6% ( n  = 91) in the pertuzumab and placebo arms, respectively (HR, 0.76; 95% CI, 0.56-1.04). The proportion of IDFS events for patients with node-positive disease was 9.2% ( n  = 139) and 12.1% ( n  = 181) in the pertuzumab and placebo arms, respectively (HR, 0.77; 95% CI, 0.62-0.96). Adverse reactions in ≥30% of patients receiving pertuzumab were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting. From a regulatory standpoint, the benefits of the addition of pertuzumab to adjuvant treatment outweighed the risks for patients with EBC at high risk of recurrence.",2019,"After 45.4-month median follow-up, the proportion of invasive disease-free survival (IDFS) events in the intent-to-treat population was 7.1% ( n  = 171) in the pertuzumab arm and 8.7% ( n  = 210) for placebo [hazard ratio (HR), 0.82; 95% confidence interval (CI), 0.67-1.00;  P  = 0.047].","['HER2-Positive Early Breast Cancer', 'patients with EBC at high risk of recurrence', 'patients with HER2-positive early breast cancer (EBC) at high risk of recurrence']","['pertuzumab or placebo', 'placebo', 'trastuzumab and chemotherapy']","['proportion of IDFS events', 'diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting', 'Adverse reactions', 'proportion of invasive disease-free survival (IDFS) events']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.185118,"After 45.4-month median follow-up, the proportion of invasive disease-free survival (IDFS) events in the intent-to-treat population was 7.1% ( n  = 171) in the pertuzumab arm and 8.7% ( n  = 210) for placebo [hazard ratio (HR), 0.82; 95% confidence interval (CI), 0.67-1.00;  P  = 0.047].","[{'ForeName': 'Lynn J', 'Initials': 'LJ', 'LastName': 'Howie', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland. lynn.howie@gmail.com.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Scher', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Choudhry', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Schroeder', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3003']
3510,29506580,The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial.,"BACKGROUND


For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet drugs results in an increase in the risk of recurrent ICH or a beneficial net reduction of all serious vascular events compared to avoiding antiplatelet drugs.
METHODS/DESIGN


The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, randomised, open, assessor-blind, parallel-group, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom. RESTART uses a central, web-based randomisation system using a minimisation algorithm, with 1:1 treatment allocation to which central research staff are masked. Central follow-up includes annual postal or telephone questionnaires to participants and their general (family) practitioners, with local provision of information about adverse events and outcome events. The primary outcome is recurrent symptomatic ICH. The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s). The magnetic resonance imaging (MRI) sub-study involves the conduct of brain MRI according to a standardised imaging protocol before randomisation to investigate heterogeneity of treatment effect according to the presence of brain microbleeds. Recruitment began on 22 May 2013. The target sample size is at least 720 participants in the main trial (at least 550 in the MRI sub-study).
DISCUSSION


Final results of RESTART will be analysed and disseminated in 2019.
TRIAL REGISTRATION


ISRCTN71907627 ( www.isrctn.com/ISRCTN71907627 ). Prospectively registered on 25 April 2013.",2018,The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s).,"['adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet', 'adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom', '720 participants in the main trial (at least 550 in the MRI sub-study', 'Prospectively registered on 25 April 2013']",['magnetic resonance imaging (MRI'],"['recurrent symptomatic ICH', 'symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.341668,The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s).,"[{'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK. Rustam.Al-Shahi@ed.ac.uk.""}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Dennis', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Innes', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Drever', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Dinsmore', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'White', 'Affiliation': 'Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Whiteley', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'Peter A G', 'Initials': 'PAG', 'LastName': 'Sandercock', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'Cathie L M', 'Initials': 'CLM', 'LastName': 'Sudlow', 'Affiliation': ""Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Werring', 'Affiliation': 'Institute of Neurology, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-018-2542-6']
3511,32024323,Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6-10 weeks: a randomized double-blind active-controlled trial.,"BACKGROUND


Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates.
PURPOSE


This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants.
METHODS


This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6-10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group.
RESULTS


After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 μg/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 μg/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003).
CONCLUSION


The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.",2020,"The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group.
","['infants aged 6 to 10 weeks ', 'healthy infants', 'subjects were eligible if they were aged 6-10 weeks and healthy', 'children aged under 5 years worldwide']","['12-valent pneumococcal conjugate vaccine', 'GBP411']","['overall incidence of solicited systemic adverse events', 'overall incidence of solicited local adverse events', 'IgG concentrations', 'immunogenicity', 'proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations', 'serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG', 'Immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.534718,"The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group.
","[{'ForeName': 'Jonghoon', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'SK bioscience, Seonam-si, Republic of Korea.'}, {'ForeName': 'Jamaree', 'Initials': 'J', 'LastName': 'Teeratakulpisarn', 'Affiliation': 'Department of Pediatrics, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Pediatrics and Center of Excellence in Pediatric Infectious Diseases and Vaccine Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Tuangtip', 'Initials': 'T', 'LastName': 'Theerawit', 'Affiliation': 'Department of Pediatrics and Center of Excellence in Pediatric Infectious Diseases and Vaccine Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ji Hwa', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'SK bioscience, Seonam-si, Republic of Korea.'}, {'ForeName': 'Jinhwan', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'SK bioscience, Seonam-si, Republic of Korea.'}, {'ForeName': 'Seulgi', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'SK bioscience, Seonam-si, Republic of Korea.'}, {'ForeName': 'Hayoung', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'SK bioscience, Seonam-si, Republic of Korea.'}, {'ForeName': 'Kyungjun', 'Initials': 'K', 'LastName': 'An', 'Affiliation': 'SK bioscience, Seonam-si, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK bioscience, Seonam-si, Republic of Korea.'}]",Clinical and experimental pediatrics,['10.3345/cep.2019.01067']
3512,31340623,"[A single-center, randomized controlled trial of PEG-rhG-CSF and common rhG-CSF to promote neutrophil recovery after induction chemotherapy in newly diagnosed acute myeloid leukemia].","Objective:  To compare the time of the recovery of neutrophils or leukocytes by pegylated recombinant human granulocyte stimulating factor (PEG-rhG-CSF) or common recombinant human granulocyte stimulating factor (rhG-CSF) in the myelosuppressive phase after induction chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients. At the same time, the incidences of infection and hospitalization were compared.  Methods:  A prospective randomized controlled trial was conducted in patients with newly diagnosed AML who met the enrollment criteria from August 2014 to December 2017. The patients were randomly divided into two groups according to a 1:1 ratio: PEG-rhG-CSF group and rhG-CSF group. The time of neutrophil or leukocyte recovery, infection rate and hospitalization interval were compared between the two groups.  Results:  60 patients with newly diagnosed AML were enrolled: 30 patients in the PEG-rhG-CSF group and 30 patients in the rhG-CSF group. There were no significant differences in age, chemotherapy regimen, pre-chemotherapy ANC, WBC, and induction efficacy between the two groups ( P >0.05) . The median time (range) of ANC or WBC recovery in patients with PEG-rhG-CSF and rhG-CSF were 19 (14-35) d and 19 (15-26) d, respectively, with no statistical difference ( P =0.566) . The incidences of infection in the PEG-rhG-CSF group and the rhG-CSF group were 90.0%and 93.3%, respectively, and there was no statistical difference ( P =1.000) . The median days of hospitalization (range) was 20.5 (17-49) days and 21 (19-43) days, respectively, with no statistical difference ( P =0.530) .  Conclusions:  In AML patients after induction therapy, there was no significant difference between the application of PEG-rhG-CSF and daily rhG-CSF in ANC or WBC recovery time, infection incidence and hospitalization time.",2019,"There were no significant differences in age, chemotherapy regimen, pre-chemotherapy ANC, WBC, and induction efficacy between the two groups ( P >0.05) .","['newly diagnosed acute myeloid leukemia', '60 patients with newly diagnosed AML were enrolled: 30 patients in the PEG-rhG-CSF group and 30 patients in the rhG-CSF group', 'patients with newly diagnosed AML who met the enrollment criteria from August 2014 to December 2017', 'newly diagnosed acute myeloid leukemia (AML) patients']","['pegylated recombinant human granulocyte stimulating factor (PEG-rhG-CSF) or common recombinant human granulocyte stimulating factor (rhG-CSF', 'PEG-rhG-CSF and common rhG-CSF', 'induction chemotherapy', 'PEG-rhG-CSF group and rhG-CSF group']","['incidences of infection', 'incidences of infection and hospitalization', 'application of PEG-rhG-CSF and daily rhG-CSF in ANC or WBC recovery time, infection incidence and hospitalization time', 'median time (range) of ANC or WBC recovery', 'median days of hospitalization (range', 'time of neutrophil or leukocyte recovery, infection rate and hospitalization interval', 'pre-chemotherapy ANC, WBC, and induction efficacy']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",60.0,0.0227259,"There were no significant differences in age, chemotherapy regimen, pre-chemotherapy ANC, WBC, and induction efficacy between the two groups ( P >0.05) .","[{'ForeName': 'K Q', 'Initials': 'KQ', 'LastName': 'Liu', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, Tianjin 300020, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'X L', 'Initials': 'XL', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Mi', 'Affiliation': ''}, {'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ''}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2019.06.009']
3513,31470769,Examining Potential Psychosocial Mediators in a Physical Activity Intervention for Older Adults.,"The purpose of this study was to examine psychosocial constructs targeted as potential mediators in a prior physical activity (PA) intervention study. This secondary analysis used data from 102 older adults randomized to one of four conditions-within a 2 (Interpersonal Strategies: yes, no) x 2 (Intrapersonal Strategies: yes, no) factorial design. We tested intervention effects on social support, self-efficacy, self-regulation, and goal attainment, and whether these constructs mediated intervention effects on PA. Participants who received interventions with interpersonal strategies, compared to those who did not, increased their readiness (post-intervention), the self-regulation subscale of self-assessment, and goal attainment (post-intervention, 6-months). Participants who received interventions with intrapersonal strategies, compared to those who did not, increased their social support from family (post-intervention). There was no statistically significant mediation. To understand mechanisms through which interventions increase older adults' PA and to improve intervention effectiveness, researchers should continue to examine potential psychosocial mediators.Clinical Trial Registry: NCT02433249.",2020,"Participants who received interventions with intrapersonal strategies, compared to those who did not, increased their social support from family (post-intervention).","['Older Adults', '102 older adults randomized to one of four conditions-within a 2 (Interpersonal Strategies: yes, no']",['Physical Activity Intervention'],"['social support, self-efficacy, self-regulation, and goal attainment']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0182743,"Participants who received interventions with intrapersonal strategies, compared to those who did not, increased their social support from family (post-intervention).","[{'ForeName': 'Siobhan K', 'Initials': 'SK', 'LastName': 'McMahon', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Oakes', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jean F', 'Initials': 'JF', 'LastName': 'Wyman', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'Division of Biostatistics, School of Public Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Rothman', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN, USA.'}]",Western journal of nursing research,['10.1177/0193945919871697']
3514,31446581,Comparison of the effects of 10.6-μm infrared laser and traditional moxibustion in the treatment of knee osteoarthritis.,"Based on two separate randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) moxibustion and 10.6-μm infrared laser moxibustion in treating knee osteoarthritis (OA), we did an indirect and preliminary comparison of the effects of the 10.6-μm laser moxibustion with the traditional moxibustion for knee osteoarthritis. The objective was to see whether the laser moxibustion is non-inferior to the traditional moxibustion in alleviating symptoms of knee osteoarthritis such as pain, stiffness, and joint dysfunction as well as improving quality of life for the patients with knee osteoarthritis, and whether a further RCT directly comparing the laser and traditional moxibustion is necessary. Pooled data from two RCTs in patients with knee osteoarthritis, trial ISRCTN68475405 and trial ISRCTN26065334, were used. In the two RCTs, the eligibility criteria were almost identical, the treatment procedure (i.e., sessions, duration, and points) were similar, and the outcome measurements (i.e., WOMAC for symptoms and SF-36 for quality of life) were the same. The double robustness method was used for the WOMAC scale and the SF-36 endpoints to detect the difference between traditional and laser moxibustion. The analysis comprised 55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group). Demographic characteristics and course of disease were similar between the two groups. Causal inference, using the doubly robust estimating approach to correct for bias due to baseline differences, showed that there was no statistically significant difference in the WOMAC pain, stiffness, and physical function between the two treatments at midterm, end of treatment, and 4 weeks after the end of treatment (P > 0.05). The exception was that there was statistically significantly more benefit associated with laser moxibustion compared with traditional moxibustion in physical function at the follow-up of 4 weeks after the end of treatment (P=0.006). There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002). The benefits of 10.6-μm infrared laser moxibustion and the traditional moxibustion for knee osteoarthritis were comparable in pain, stiffness, physical dysfunction, and in most of the quality of life subdimensions. The laser moxibustion might be more beneficial in terms of physical function, body pain, and mental health in the long term. RCTs directly comparing 10.6-μm laser moxibustion with traditional moxibustion are warranted.",2020,"There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002).","['knee osteoarthritis (OA', '55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group', 'patients with knee osteoarthritis', 'knee osteoarthritis']","['10.6-μm infrared laser and traditional moxibustion', 'laser moxibustion', '10.6-μm laser moxibustion with the traditional moxibustion', 'traditional Chinese medicine (TCM) moxibustion and 10.6-μm infrared laser moxibustion', '10.6-μm infrared laser moxibustion']","['most SF-36 endpoints', 'pain, stiffness, physical dysfunction', 'physical function, body pain, and mental health', 'Demographic characteristics and course of disease', 'WOMAC pain, stiffness, and physical function', 'WOMAC scale', 'physical function', 'WOMAC for symptoms and SF-36 for quality of life', 'physical functioning (PF), mental health (MH), and bodily pain (BP']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.0449206,"There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China. cheng_ker@hotmail.com.'}, {'ForeName': 'Ming T', 'Initials': 'MT', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, Bioinformatics & Biomathematics, Georgetown University Medical Center, Washington, D.C., 20057, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Zouqin', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Shanghai Pudong New Area Hospital of Traditional Chinese Medicine, Shanghai, 201299, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Zhongshan Hospital of Zhejiang Province, Hangzhou, 310005, Zhejiang Province, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Haimeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Xueyong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China. sxy1@shutcm.edu.cn.'}]",Lasers in medical science,['10.1007/s10103-019-02863-9']
3515,30814121,Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled study.,"OBJECTIVE


The effect of colonoscopy on colorectal cancer mortality is limited by several factors, among them a certain miss rate, leading to limited adenoma detection rates (ADRs). We investigated the effect of an automatic polyp detection system based on deep learning on polyp detection rate and ADR.
DESIGN


In an open, non-blinded trial, consecutive patients were prospectively randomised to undergo diagnostic colonoscopy with or without assistance of a real-time automatic polyp detection system providing a simultaneous visual notice and sound alarm on polyp detection. The primary outcome was ADR.
RESULTS


Of 1058 patients included, 536 were randomised to standard colonoscopy, and 522 were randomised to colonoscopy with computer-aided diagnosis. The artificial intelligence (AI) system significantly increased ADR (29.1%vs20.3%, p<0.001) and the mean number of adenomas per patient (0.53vs0.31, p<0.001). This was due to a higher number of diminutive adenomas found (185vs102; p<0.001), while there was no statistical difference in larger adenomas (77vs58, p=0.075). In addition, the number of hyperplastic polyps was also significantly increased (114vs52, p<0.001).
CONCLUSIONS


In a low prevalent ADR population, an automatic polyp detection system during colonoscopy resulted in a significant increase in the number of diminutive adenomas detected, as well as an increase in the rate of hyperplastic polyps. The cost-benefit ratio of such effects has to be determined further.
TRIAL REGISTRATION NUMBER


ChiCTR-DDD-17012221; Results.",2019,"The artificial intelligence (AI) system significantly increased ADR (29.1%vs20.3%, p<0.001) and the mean number of adenomas per patient (0.53vs0.31, p<0.001).","['1058 patients included, 536 were randomised to']","['Real-time automatic detection system', 'diagnostic colonoscopy with or without assistance of a real-time automatic polyp detection system providing a simultaneous visual notice and sound alarm on polyp detection', 'standard colonoscopy', 'colonoscopy', 'automatic polyp detection system', 'colonoscopy with computer-aided diagnosis']","['number of diminutive adenomas', 'ADR', 'rate of hyperplastic polyps', 'number of hyperplastic polyps', 'colorectal cancer mortality', 'polyp detection rate and ADR', 'artificial intelligence (AI) system significantly increased ADR', 'automatic polyp detection system', 'colonoscopic polyp and adenoma detection rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon (procedure)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0333983', 'cui_str': 'Metaplastic polyp (morphologic abnormality)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0003916', 'cui_str': 'AI (Artificial Intelligence)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]",1058.0,0.199192,"The artificial intelligence (AI) system significantly increased ADR (29.1%vs20.3%, p<0.001) and the mean number of adenomas per patient (0.53vs0.31, p<0.001).","[{'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Berzin', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeremy Romek', 'Initials': 'JR', 'LastName': 'Glissen Brown', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Shishira', 'Initials': 'S', 'LastName': 'Bharadwaj', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Becq', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Peixi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Liangping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Guangre', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Mengtian', 'Initials': 'M', 'LastName': 'Tu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}]",Gut,['10.1136/gutjnl-2018-317500']
3516,31020621,Using a Culturally Tailored Narrative to Increase Cervical Cancer Detection Among Spanish-Speaking Mexican-American Women.,"The objective of this study was to determine the feasibility and effectiveness of translating films, and whether the use of narrative is an effective vehicle for producing changes in knowledge, attitudes, and behaviors regarding cervical cancer compared with a nonnarrative film. A randomized controlled telephone trial surveyed the effectiveness of two films our team produced among a sample of 300 monolingual Spanish-speaking women, ages 25 to 45, who were of Mexican origin. Participants were recruited using random digit dialing (RDD) procedures from 2013 to 2014 in Los Angeles County and were randomly selected to view either a narrative or nonnarrative film. Data were collected by phone at baseline, 2 weeks, and 6 months after viewing. On average, participants arrived in the USA 25 years ago. The majority reported having less than high school education and limited English proficiency. Compared with their nonnarrative counterparts, women who received the cervical cancer-related information in the narrative film showed a significantly greater increase in new knowledge (p = 0.01) and in supportive attitudes about Pap tests expense (p = 0.05). Importantly, at 6 months, although not statistically significant, women who viewed the narrative film were also more likely to have had or scheduled a Pap test (62% vs 42%). Narratives are a useful and underutilized tool to communicate information about cancer prevention. These findings have important implications for the delivery of health education among Spanish-speaking, low-literacy immigrant women, and for the reduction of cancer-related disparities.",2020,"Importantly, at 6 months, although not statistically significant, women who viewed the narrative film were also more likely to have had or scheduled a Pap test (62% vs 42%).","['300 monolingual Spanish-speaking women, ages 25 to 45, who were of Mexican origin', 'Participants were recruited using random digit dialing (RDD) procedures from 2013 to 2014 in Los Angeles County', 'Spanish-Speaking Mexican-American Women']","['Culturally Tailored Narrative', 'narrative or nonnarrative film']","['supportive attitudes about Pap tests expense', 'new knowledge']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0025884', 'cui_str': 'Chicanas'}]","[{'cui': 'C4319646', 'cui_str': 'Film'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0282794,"Importantly, at 6 months, although not statistically significant, women who viewed the narrative film were also more likely to have had or scheduled a Pap test (62% vs 42%).","[{'ForeName': 'Carol Y', 'Initials': 'CY', 'LastName': 'Ochoa', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, 2001 N. Soto Street, Los Angeles, CA, 90033, USA. caroloch@usc.edu.'}, {'ForeName': 'Sheila T', 'Initials': 'ST', 'LastName': 'Murphy', 'Affiliation': 'Annenberg School for Communication and Journalism, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Frank', 'Affiliation': 'Department of Communication, Portland State University, Portland, OR, USA.'}, {'ForeName': 'Lourdes A', 'Initials': 'LA', 'LastName': 'Baezconde-Garbanati', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, and Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01521-6']
3517,30945105,Intravenous dexmedetomidine for the treatment of shivering during Cesarean delivery under neuraxial anesthesia: a randomized-controlled trial.,"PURPOSE


About 55% of patients undergoing a Cesarean delivery under spinal or epidural anesthesia will experience shivering, which may interfere with the monitoring of vital signs. Recent studies have shown that dexmedetomidine could potentially help to alleviate shivering associated with anesthesia. We investigated whether dexmedetomidine, an alpha 2-adrenergic agonist, reduces the duration of shivering associated with neuraxial anesthesia during Cesarean delivery.
METHODS


Eighty parturients undergoing Cesarean delivery under neuraxial anesthesia and experiencing shivering were enlisted in this prospective, randomized, double-blind trial. After childbirth, the intervention group (n = 40) received a single intravenous bolus of dexmedetomidine (30 µg) while the control group (n = 40) received saline. Randomization and allocation were based on a computer-generated list. The primary outcome measure was the time required for an observable decrease in shivering after the intervention.
RESULTS


One hundred fifty-five patients were recruited, 80 of whom presented with shivering and were randomized. Our study showed that dexmedetomidine reduced the mean (standard deviation) duration of shivering after a single intravenous bolus to 2.6 (2.1) min after dexmedetomidine from 17.9 (12.6) min after saline (difference in means, -15.3 min; 95% confidence interval [CI], -11.2 to -19.4). The effect of dexmedetomidine persisted 15 min after the bolus was administered, as shivering had completely stopped in 90% of the patients in the intervention group vs 22.5% in the control group (relative risk, 4.0; 95% CI, 2.2 to 7.2). No adverse effects, including bradycardia, were observed.
CONCLUSION


A single intravenous bolus of dexmedetomidine decreased the duration of shivering for up to 15 min during Cesarean delivery under neuraxial anesthesia.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02384343); registered 10 March, 2015.",2019,"A single intravenous bolus of dexmedetomidine decreased the duration of shivering for up to 15 min during Cesarean delivery under neuraxial anesthesia.
","['One hundred fifty-five patients were recruited, 80 of whom presented with shivering and were randomized', 'shivering during Cesarean delivery under neuraxial anesthesia', 'Eighty parturients undergoing Cesarean delivery under neuraxial anesthesia and experiencing shivering', 'patients undergoing a Cesarean delivery under spinal or epidural anesthesia']","['Intravenous dexmedetomidine', 'saline', 'dexmedetomidine']","['time required for an observable decrease in shivering', 'mean (standard deviation) duration of shivering', 'duration of shivering', 'adverse effects, including bradycardia', 'shivering']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}]",80.0,0.536914,"A single intravenous bolus of dexmedetomidine decreased the duration of shivering for up to 15 min during Cesarean delivery under neuraxial anesthesia.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lamontagne', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada. christina.lamontagne@umontreal.ca.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lesage', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Villeneuve', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Lidzborski', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Derstenfeld', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Crochetière', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01354-3']
3518,31519441,The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial.,"OBJECTIVE


To compare changes in lung volumes, as measured by functional residual capacity (FRC), through to discharge in stable infants randomized to 2 weeks of extended continuous positive airway pressure CPAP (eCPAP) vs CPAP discontinuation (dCPAP).
STUDY DESIGN


Infants born at ≤32 weeks of gestation requiring ≥24 hours of CPAP were randomized to 2 weeks of eCPAP vs dCPAP when meeting CPAP stability criteria. FRC was measured with the nitrogen washout technique. Infants were stratified by gestational age (<28 and ≥ 28 weeks) and twin gestation. A linear mixed-effects model was used to evaluate the change in FRC between the 2 groups. Data were analyzed blinded to treatment group allocation.
RESULTS


Fifty infants were randomized with 6 excluded, for a total of 44 infants. Baseline characteristics were similar in the 2 groups. The infants randomized to eCPAP vs dCPAP had a greater increase in FRC from randomization through 2 weeks (12.6 mL vs 6.4 mL; adjusted 95% CI, 0.78-13.47; P = .03) and from randomization through discharge (27.2 mL vs 17.1 mL; adjusted 95% CI, 2.61-17.59; P = .01).
CONCLUSIONS


Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP. An increased change in FRC may lead to improved respiratory health.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02249143.",2020,"CONCLUSIONS


Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP.","['Infants were stratified by gestational age (<28 and\xa0≥\xa028\xa0weeks) and twin gestation', 'Fifty infants were randomized with 6 excluded, for a total of 44 infants', 'Stable Premature Infants', 'Infants born at ≤32\xa0weeks of gestation requiring ≥24\xa0hours of CPAP']","['extended continuous positive airway pressure CPAP (eCPAP) vs CPAP discontinuation (dCPAP', 'eCPAP vs dCPAP', 'eCPAP', 'Extended Continuous Positive Airway Pressure']","['Lung Volumes', 'FRC', 'FRC through discharge']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0016815', 'cui_str': 'Functional Residual Capacity'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",50.0,0.394834,"CONCLUSIONS


Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Schilling', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Scottoline', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Platteau', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Niederhausen', 'Affiliation': 'Biostatistics and Design Program, Oregon Health & Science University-Portland State University School of Public Health, Portland, OR.'}, {'ForeName': 'Kelli C', 'Initials': 'KC', 'LastName': 'Lund', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Kelvin D', 'Initials': 'KD', 'LastName': 'MacDonald', 'Affiliation': 'Division of Pediatric Pulmonology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR. Electronic address: mcevoyc@ohsu.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.07.074']
3519,31553946,Effectiveness of the 5A's Model for Changing Physical Activity Behaviors in Rural Adults Recruited From Primary Care Clinics.,"BACKGROUND


Most rural adults do not meet current guidelines for physical activity (PA). A 12-week feasibility study tested the effectiveness of using the 5A's model for PA counseling on rural adults' PA behaviors.
METHODS


Inactive rural adults recruited from a primary care clinic were randomized to an intervention (n = 30) or control (n = 29) group. All subjects wore a Fitbit to track steps and active minutes. The intervention group completed action plans to improve self-regulatory PA strategies and received weekly motivational text messages to improve PA behaviors. Theory of planned behavior constructs and self-regulatory strategies of planning, goal setting, and tracking (steps and active minutes) were measured with both groups. The control group received the Fitbit only.
RESULTS


All individuals became more physically active; however, no significant differences between groups in active minutes or steps were found. All subjects, regardless of group, increased steps (P > .05). There were no statistically significant differences between groups on any of the theoretical variables.
CONCLUSIONS


It is vitally important to continue to find ways to make PA a priority to improve the overall health and well-being of rural adults. Future research warrants adjusting the intervention dose and strategies to increase PA that can be maintained long term.",2019,"All subjects, regardless of group, increased steps (P > .05).","[""rural adults' PA behaviors"", 'Inactive rural adults recruited from a primary care clinic', 'Rural Adults Recruited From Primary Care Clinics', 'rural adults']","[""5A's model for PA counseling"", 'action plans to improve self-regulatory PA strategies and received weekly motivational text messages', ""5A's Model""]",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],,0.0202682,"All subjects, regardless of group, increased steps (P > .05).","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Reed', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Estabrooks', 'Affiliation': ''}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Heelan', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wichman', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0477']
3520,30951772,Anticipation of aerobic exercise increases planned energy intake for a post-exercise meal.,"In many situations, meals are planned (i.e. what and how much) before they are eaten, but how exercise influences this planning is unknown. Therefore, this study investigated whether anticipation of an exercise session alters food intake planned for post-exercise. Forty (16 male) regular exercisers (mean ± SD; age 23.3 ± 5.6 y, BMI 22.7 ± 3.3 kg/m 2 , body fat 25.6 ± 7.6%) completed the study. Subjects arrived ≥3 h post-prandial and were given two hypothetical scenarios for the following day: 1) morning rest (REST), or 2) morning rest with the addition of 1 h of hard aerobic exercise at 10:00-11:00 (EXERCISE). For each scenario subjects had to plan their lunch, to consume at 12:00, by serving themselves cheesy tomato pasta and chocolate buttons. Scenarios were randomised and separated by 5 min and foods were not consumed. EXERCISE increased total energy served by 24% (EXERCISE 3308 ± 1217 kJ; REST 2663 ± 924 kJ; P < 0.001), with increases in energy served from both pasta (+25%; P < 0.001) and chocolate buttons (+20%; P = 0.024). These results suggest aerobic exercise increases planned post-exercise energy intake, if a meal is planned in advance of exercise. Future research should examine the impact of exercise on meal planning at other meals, as well as how this behaviour impacts weight loss with exercise training.",2019,EXERCISE increased total energy served by 24%,"['Forty (16 male) regular exercisers (mean\u202f±\u202fSD; age 23.3\u202f±\u202f5.6\u202fy, BMI 22.7\u202f±\u202f3.3\u202fkg/m 2 , body fat 25.6\u202f±\u202f7.6%) completed the study', '3308']","['aerobic exercise', 'morning rest (REST), or 2) morning rest with the addition of 1\u202fh of hard aerobic exercise', 'exercise session alters food intake planned for post-exercise']","['chocolate buttons', 'planned energy intake', 'total energy']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}]","[{'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.147878,EXERCISE increased total energy served by 24%,"[{'ForeName': 'Asya', 'Initials': 'A', 'LastName': 'Barutcu', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Gemma L', 'Initials': 'GL', 'LastName': 'Witcomb', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK. Electronic address: L.James@lboro.ac.uk.'}]",Appetite,['10.1016/j.appet.2019.03.035']
3521,30721940,Falls After Hospital Discharge: A Randomized Clinical Trial of Individualized Multimodal Falls Prevention Education.,"BACKGROUND


Older people are at high risk of falls after hospital discharge. The study aimed to evaluate the effect of providing individualized falls prevention education in addition to usual care on falls rates in older people after hospital discharge compared to providing a social intervention in addition to usual care.
METHODS


A randomized clinical trial at three hospitals in Western Australia: participants followed for 6 months after discharge. Baseline and outcomes measured by assessors masked to group allocation. Participants: aged 60 years and over, admitted for rehabilitation. Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10). Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist. Main outcomes: falls in the 6 months after discharge; proportion of participants sustaining one or more falls.
RESULTS


There were 382 (194 intervention; 188 control) participants (mean age 77.7 [SD 8.7] years). There were 378 falls (fall rate per 1,000 patient-days, 5.9 intervention; 5.9 control) reported by 164 (42.9%) participants in the 6 months following hospital discharge; 188 (49.7%) of these falls were injurious. There were no significant differences in falls rates between intervention and control groups: (adjusted IRR, 1.09; 95% CI [0.78 to 1.52]) or the proportion of participants who fell once or more (adjusted OR, 1.37; 95% CI [0.90 to 2.07]).
CONCLUSIONS


Providing individualized falls prevention education prior to discharge did not reduce falls at home after discharge. Further research is warranted to investigate how to reduce falls during this high-risk transition period.",2019,"There were no significant differences in falls rates between intervention and control groups: [adjusted IRR, 1.09; 95% CI (0.78 to 1.52)] or the proportion of participants who fell once or more [adjusted OR, 1.37; 95% CI (0.90 to 2.07)].
","['older people after hospital discharge', 'Falls after hospital discharge', 'There were 382 (194 intervention; 188 control) participants [mean age 77.7 (SD 8.7) years', 'Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10', 'Participants: aged 60 years and over, admitted for rehabilitation']","['social intervention', 'individualized multi-modal', 'individualized falls prevention education', 'Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist']","['discharge; proportion of participants sustaining one or more falls', 'falls rates']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2960765', 'cui_str': 'Abbreviated mental test score'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",,0.217539,"There were no significant differences in falls rates between intervention and control groups: [adjusted IRR, 1.09; 95% CI (0.78 to 1.52)] or the proportion of participants who fell once or more [adjusted OR, 1.37; 95% CI (0.90 to 2.07)].
","[{'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'Healthscope and La Trobe Centre for Sport and Exercise Medicine Research, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Etherton-Beer', 'Affiliation': 'Western Australian Centre for Health & Ageing, Medical School, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall VA Medical Center, Geriatric Research Education and Clinical Center (GRECC), Gainesville, Florida.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Western Australian Centre for Health & Ageing, Medical School, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Waldron', 'Affiliation': 'Department of Aged Care and Rehabilitation, Armadale Kelmscott Memorial Hospital, East Metropolitan Health Service, Armadale, Western Australia, Australia.'}, {'ForeName': 'Den-Ching A', 'Initials': 'DA', 'LastName': 'Lee', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Francis-Coad', 'Affiliation': 'School of Physiotherapy, Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Boudville', 'Affiliation': 'Department of Aged Care and Rehabilitation, St John of God Midland Public and Private Hospital, Midland, Western Australia, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz026']
3522,31525164,The impact of thoracic paravertebral block over post-operatory evolution in open lobectomy.,"AIM


The thoracic paravertebral block (PVB), a technique of post-thoracotomy analgesia of similar effectiveness as continuous epidural analgesia (CEA) but with a better safety profile, is underutilized in current practice. This study compares the outcome of post-lobectomy patients in relation to the analgesic method used: parenteral analgesia (PA) vs. PVB + PA, and provides justification for the routine use of PVB in all patients where CEA is contraindicated.
METHODS


We randomized 213 consecutive patients undergoing open lobectomy to benefit from two different protocols of postoperative analgesia: PA vs. PVB +PA. We compared the frequency of cardiac hemodynamic, respiratory, pleural or surgical-related complications.
RESULTS


After lobectomy, the PVB patients (72/213) were found to have a significantly lower frequency of congestive heart failure (7.1%vs.0.0%)(p=0.049), ischemic cardiomyopathy (10.6%vs.0.0%)(p=0.010), pulmonary atelectasis (35%vs.1.1%)(p<0.001), residual pleural space (29.8%vs.15.3%)(p=0.032) and residual intrapleural blood clots (14.9%vs.1.4%)(p=0.005). Other postoperative complications, Intensive Care stay, total hospital stay and mortality rate were less frequent in the PVB group but without reaching statistical significance.
CONCLUSION


The use of SPVB is associated with significant less postoperative complications than PA only. This study suggests that the SPVB might be the ideal choice in post-thoracotomy pain management when CEA cannot be used.
KEY WORDS


Open lobectomy, Post-lobectomy, Thoracic paravertebral block.",2019,"Other postoperative complications, Intensive Care stay, total hospital stay and mortality rate were less frequent in the PVB group but without reaching statistical significance.
","['213 consecutive patients undergoing open lobectomy to benefit from two different protocols of', 'open lobectomy']","['continuous epidural analgesia (CEA', 'thoracic paravertebral block', 'postoperative analgesia: PA vs. PVB +PA', 'parenteral analgesia (PA) vs. PVB + PA', 'Open lobectomy, Post-lobectomy, Thoracic paravertebral block', 'thoracic paravertebral block (PVB']","['congestive heart failure', 'residual pleural space', 'residual intrapleural blood clots', 'frequency of cardiac hemodynamic, respiratory, pleural or surgical-related complications', 'pulmonary atelectasis', 'postoperative complications', 'postoperative complications, Intensive Care stay, total hospital stay and mortality rate', 'ischemic cardiomyopathy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0085559'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}]",213.0,0.0264365,"Other postoperative complications, Intensive Care stay, total hospital stay and mortality rate were less frequent in the PVB group but without reaching statistical significance.
","[{'ForeName': 'Bogdan I', 'Initials': 'BI', 'LastName': 'Popovici', 'Affiliation': ''}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Matei', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Iacoban', 'Affiliation': ''}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Simion', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Man', 'Affiliation': ''}, {'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Al Hajjar', 'Affiliation': ''}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Mois', 'Affiliation': ''}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Popovici', 'Affiliation': ''}, {'ForeName': 'Romeo', 'Initials': 'R', 'LastName': 'Chira', 'Affiliation': ''}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Iancu', 'Affiliation': ''}]",Annali italiani di chirurgia,[]
3523,30793734,Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial.,"AIMS


After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment.
METHODS AND RESULTS


In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35-0.63) for 110 mg and 0.67 (0.50-0.90) for 150 mg]; elective PCI [0.57 (0.43-0.76) for 110 mg and 0.76 (0.56-1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28-0.76) for 110 mg and 0.59 (0.34-1.04) for 150 mg]; or clopidogrel [0.51 (0.41-0.64) for 110 mg and 0.73 (0.58-0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.
CONCLUSION


The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.",2019,"Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.
","['patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving', 'atrial fibrillation patients with or without acute coronary syndrome', 'patients with atrial fibrillation', '2725 patients']","['dabigatran 110\u2009mg or 150\u2009mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin', 'dabigatran dual therapy', 'ticagrelor or clopidogrel', 'ticagrelor', 'percutaneous coronary intervention (PCI', 'warfarin triple therapy']","['risk of the primary endpoint, major or clinically relevant non-major bleeding event', 'bleeding risks', 'elective PCI', 'death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",2725.0,0.0370188,"Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.
","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Dag Hammarskjölds väg 38, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, an F-CRIN Network, Université Paris Diderot, INSERM U_1148 and Hôpital Bichat Assistance Publique, Paris, France.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Medicine, Division of Cardiology, Johann Wolfgang Goethe University, Theodor Stern-Kai 7, DE-60590 Frankfurt/Main, Germany.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, TA CardioMetabolism, Binger Str. 173, Ingelheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, TA CardioMetabolism, Binger Str. 173, Ingelheim, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Boehringer Ingelheim International GmbH, TA CardioMetabolism, Binger Str. 173, Ingelheim, Germany.'}, {'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Ziekenhuis, Koekoekslaan 1, Nieuwegein 3435 CM, The Netherlands.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Heart and Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA, USA.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital, Heart and Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA, USA.""}]",European heart journal,['10.1093/eurheartj/ehz059']
3524,31478755,Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial.,"Objective:  A randomized pilot trial of gastrointestinal (GI) symptoms targeting probiotic for quality of life in autism spectrum disorder (ASD).  Methods:  Thirteen children, 3-12 years of age with ASD, anxiety, and GI symptoms, were randomized into a probiotic crossover trial of 8 weeks each on VISBIOME and placebo separated by a 3-week washout. VISBIOME contains eight probiotic species, mostly  Lactobacillus  and  Bifidobacterium . Primary outcome was the Pediatric Quality of Life Inventory (PedsQL) GI module. Secondary outcomes included gut microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and parent-selected target symptoms. A mixed analysis model was applied.  Results:  Thirteen children were randomized, with 10 completing the study (77% retention): 6 in probiotic/placebo sequence, 4 in placebo/probiotic sequence. Adherence to study treatment was 96%. There were no serious adverse events (AEs), and more nonserious AEs occurred with placebo than with probiotic, including those attributable to treatment. Only 6 of the 10 guessed the correct treatment at the end of week 8. Over the 19-week trial, each outcome improved from baseline and PedsQL correlated significantly with abundance of  Lactobacillus  without discernable changes to microbiota composition/diversity. Although probiotic showed more improvement than placebo, PedsQL and PRAS-ASD were not statistically significant, as expected at this sample size. PedsQL effect size was  d  = 0.49 by the general model and  d  = 0.79 by simple comparison of week 8 changes. A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79). Probiotic effects carried over through the 3-week washout.  Conclusion:  The VISBIOME formulation was safe and suggested a health benefit in children with ASD and GI symptoms who retained  Lactobacillus . The moderate effect size compared with placebo warrants a larger trial using a parallel-group design.",2019,"A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79).","['children with ASD and GI symptoms who retained  Lactobacillus ', 'Thirteen children', 'autism spectrum disorder (ASD', 'Autism', 'Thirteen children, 3-12 years of age with ASD, anxiety, and GI symptoms']","['probiotic/placebo sequence, 4 in placebo/probiotic sequence', 'Probiotics', 'placebo', 'Placebo', 'gastrointestinal (GI) symptoms targeting probiotic']","['Gastrointestinal Symptoms and Quality of Life', 'Pediatric Quality of Life Inventory (PedsQL', 'Probiotic effects', 'PedsQL effect size', 'serious adverse events (AEs), and more nonserious AEs', 'GI complaints', 'gut microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and parent-selected target symptoms', 'placebo, PedsQL and PRAS-ASD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0034380'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",13.0,0.449744,"A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79).","[{'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Ruth Ann', 'Initials': 'RA', 'LastName': 'Luna', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Qinglong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Hollway', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Jeffs', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Coury', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Hayes', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Savidge', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0156']
3525,30925267,"Antisuicidal effect, BDNF Val66Met polymorphism, and low-dose ketamine infusion: Reanalysis of adjunctive ketamine study of Taiwanese patients with treatment-resistant depression (AKSTP-TRD).","BACKGROUND


Growing evidence suggests a rapid antisuicidal effect of low-dose ketamine infusion in Caucasian patients with treatment-resistant depression (TRD). However, the antisuicidal effects of ketamine on Taiwanese patients with TRD remains unknown.
METHODS


Seventy-one patients with TRD were randomly classified into three treatment groups: 0.5 mg/kg ketamine, 0.2 mg/kg ketamine, or normal saline (placebo) infusion. The Hamilton Depression Rating Scale (HAMD) and Montgomery-Åsberg Depression Rating Scale (MADRS) were applied prior to initiation of test infusions, at 40, 80, 120, and 240 min postinfusion, and sequentially on Days 2, 3, 4, 5, 6, 7, and 14 after ketamine or placebo infusion. Item 3 (suicide) of the HAMD and item 10 (suicidal thoughts) of the MADRS were extracted for generalized estimating equation (GEE) model analyses to investigate the antisuicidal effects of ketamine infusion. Brain-derived neurotrophic factor (BDNF) Val66Met polymorphism was genotyped.
RESULTS


The GEE model revealed significant group (p = 0.007) and time (p = 0.004) effects on suicidal symptoms over times (prior to infusion to day 14 postinfusion). The group that received 0.5 mg/kg ketamine infusion exhibited a significantly lower score in item 3 of the HAMD and item 10 of the MADRS compared with the groups that received 0.2 mg/kg ketamine or placebo infusion. Among those carrying any Val allele of BDNF, both 0.5 and 0.2 mg/kg ketamine infusions were effective in reducing suicidal thoughts; however, among those with Met/Met of BDNF, only 0.5 mg/kg ketamine infusion was effective in reducing suicidal thoughts.
DISCUSSION


A single low-dose ketamine infusion was effective in reducing suicidal ideation among Taiwanese patients with TRD. BDNF Val66Met polymorphism may play a crucial role in the antisuicidal effects of ketamine infusion.",2019,The group that received 0.5 mg/kg ketamine infusion exhibited a significantly lower score in item 3 of the HAMD and item 10 of the MADRS compared with the groups that received 0.2 mg/kg ketamine or placebo infusion.,"['Taiwanese patients with treatment-resistant depression (AKSTP-TRD', 'Caucasian patients with treatment-resistant depression (TRD', 'Taiwanese patients with TRD', 'Seventy-one patients with TRD']","['ketamine', 'Brain-derived neurotrophic factor (BDNF', 'placebo', 'ketamine, 0.2\u202fmg/kg ketamine, or normal saline (placebo) infusion', 'ketamine or placebo']","['suicidal symptoms', 'suicidal ideation', 'Hamilton Depression Rating Scale (HAMD) and Montgomery-Åsberg Depression Rating Scale (MADRS', 'suicidal thoughts']","[{'cui': 'C1556096', 'cui_str': 'Taiwanese (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",71.0,0.0604274,The group that received 0.5 mg/kg ketamine infusion exhibited a significantly lower score in item 3 of the HAMD and item 10 of the MADRS compared with the groups that received 0.2 mg/kg ketamine or placebo infusion.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan. Electronic address: on5083@msn.com.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Me Tung-Ping Su dical Research, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Department of Me Tung-Ping Su dical Research, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: tomsu0402@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2019.03.075']
3526,31100124,Efficacy of Probiotic Prophylaxis After The First Febrile Urinary Tract Infection in Children With Normal Urinary Tracts.,"BACKGROUND


Growing antibiotic resistance and debates over their efficacy for urinary tract infection (UTI) recurrence warrants studying nonantibiotic prophylaxis for preventing UTI recurrences.
METHODS


We randomly assigned 181 children, aged 4 months to 5 years, with a normal urinary tract after recovery from their first febrile UTI in a 1:1 ratio to receive a probiotic mixture of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, and Bifidobacterium lactis (n = 91) or placebo (n = 90) for a total of 18 months of therapy. The primary objective was to show the superiority of probiotic prophylaxis to placebo. The primary end point was composite cure (UTI-free survival) at 18 months, and the secondary end point was the median time to first UTI recurrence.
RESULTS


The probiotics were superior to placebo with respect to the primary efficacy end point. At 18 months, composite cure was observed in 96.7% (3 of 91) of the patients in the probiotic group and 83.3% (15 of 90) of those in the placebo group (P = .02). The median time to the first incidence of UTI recurrence was 3.5 months (range, 1-4 months) and 6.5 months (range, 2-14 months) in the probiotic and placebo groups, respectively (P = .04). The main microorganism that caused recurrent UTI was Escherichia coli, followed by Klebsiella pneumoniae, and these results were not significantly different between the 2 groups. We found no specific adverse events among the participants who received the probiotic mixture during the course of therapy.
CONCLUSIONS


The probiotics were more effective than placebo at reducing the risk of recurrent UTI in children with a normal urinary tract after their first episode of febrile UTI.",2020,The probiotics were more effective than placebo at reducing the risk of recurrent UTI in children with a normal urinary tract after their first episode of febrile UTI.,"['Children With Normal Urinary Tracts', '181 children, aged 4 months to 5 years, with a normal urinary tract after recovery from their first febrile UTI in a 1:1 ratio to receive a']","['Probiotic Prophylaxis', 'probiotic mixture', 'placebo', 'probiotic mixture of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, and Bifidobacterium lactis (n = 91) or placebo']","['composite cure (UTI-free survival', 'median time to first UTI recurrence', 'risk of recurrent UTI', 'median time to the first incidence of UTI recurrence', 'composite cure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0042027'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",181.0,0.0976912,The probiotics were more effective than placebo at reducing the risk of recurrent UTI in children with a normal urinary tract after their first episode of febrile UTI.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sadeghi-Bojd', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Naghshizadian', 'Affiliation': 'Department of Pediatrics, Section of Nephrology, Kurdistan University of Medical Science, Sanandaj, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mazaheri', 'Affiliation': 'Department of Pediatrics, Section of Nephrology, Semnan University of Medical Science1 Semnan, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ghane Sharbaf', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, Dr Sheikh Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Assadi', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, Rush University Medical Center, Chicago, Illinois.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piz025']
3527,31613129,Family-centered alcohol use prevention for African American adolescents: A randomized clinical trial.,"OBJECTIVE


The efficacy of the Strong African American Families (SAAF) alcohol use prevention program was tested. SAAF is a 7-session family skills training program offered in community settings. To overcome limitations of a past trial that used intent-to-treat (ITT) analyses, a Complier Average Causal Effect (CACE) analysis was used to estimate intervention effects and to determine the precise dosage of the intervention needed to achieve alcohol deterrence.
METHOD


A sample of 472 African American youth and their caregivers were recruited randomly from public schools in 7 rural Georgia counties. Families were assigned randomly to receive SAAF or a no-treatment control. Youth provided data on their alcohol use during the past 3 months at 4 home visits, the final occurring 34 months after baseline and 28 months after the intervention.
RESULTS


Efficacy was tested with Poisson latent growth curve models. SAAF deterred growth in alcohol use in models using both ITT and CACE estimation. CACE analyses revealed that, among participants who received a full dose of the intervention (7 sessions), a large treatment effect on slowed growth in alcohol use emerged (β = -.83, p < .001). Dose-response analyses in CACE models revealed a medium-sized effect (d [95% CI] = 1.51 [1.25, 1.75]) when participants attended at least 5 of the 7 sessions offered.
CONCLUSIONS


Replication of SAAF in a second randomized prevention trial supports the robustness of program effects. It is critical, however, that participant engagement protocols be designed to encourage participation in as at least 5 of the 7 sessions. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,SAAF deterred growth in alcohol use in models using both ITT and CACE estimation.,"['African American adolescents', '472 African American youth and their caregivers were recruited randomly from public schools in 7 rural Georgia counties']","['SAAF', 'Family-centered alcohol use prevention', 'SAAF or a no-treatment control']",[],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],2019.0,0.0344892,SAAF deterred growth in alcohol use in models using both ITT and CACE estimation.,"[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kogan', 'Affiliation': 'Department of Human Development and Family Science, University of Georgia.'}, {'ForeName': 'Dayoung', 'Initials': 'D', 'LastName': 'Bae', 'Affiliation': 'Center for Family Research, University of Georgia.'}, {'ForeName': 'Man-Kit', 'Initials': 'MK', 'LastName': 'Lei', 'Affiliation': 'Center for Family Research, University of Georgia.'}, {'ForeName': 'Gene H', 'Initials': 'GH', 'LastName': 'Brody', 'Affiliation': 'Center for Family Research, University of Georgia.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000448']
3528,31081651,Barriers to participation in web-based and in-person weight management interventions for serious mental illness.,"OBJECTIVE


This study examines barriers to participation and retention in 2 modalities (web-based and in-person) of a weight-management intervention tailored for individuals with serious mental illness (SMI).
METHOD


Using a mixed-methods approach, we explored the barriers veterans with SMI face when participating in a web-based (WebMOVE) or in-person (MOVE-SMI) version of the same SMI-adapted MOVE weight-management program. Participants in the randomized controlled trial (n = 277) were recruited from specialty mental health clinics at a Veterans Affairs medical center. Barriers were analyzed across treatment condition and program attendance (engagement) at baseline and follow-up using a generalized lineal model. Post hoc analyses assessed whether changes in the trajectory of barriers over time were associated with engagement. A subsample of participants (n = 48) from the WebMOVE and MOVE-SMI treatment conditions completed a qualitative interview, and 2 coders used open coding to analyze the data.
RESULTS


Although barriers specific to treatment modality existed, most barriers cut across intervention modality, including financial hardship, lack of reliable housing and transportation, comorbid physical and mental health issues, and competing demands on personal time. Results of post hoc analyses found the association between engagement and emotional and motivational factors to be statistically significant.
CONCLUSIONS


This study is the 1st to identify barriers in a web-based intervention for SMI. Similar barriers persisted across treatment modalities. Known barriers, particularly socioeconomic barriers, should be addressed to improve engagement and retention of individuals in weight-management interventions adapted for SMI, irrespective of modality. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Results of post hoc analyses found the association between engagement and emotional and motivational factors to be statistically significant.
","['Participants in the randomized controlled trial (n = 277) were recruited from specialty mental health clinics at a Veterans Affairs medical center', 'A subsample of participants (n = 48) from the WebMOVE and MOVE-SMI treatment conditions completed a qualitative interview, and 2 coders used open coding to analyze the data', 'individuals with serious mental illness (SMI', 'barriers veterans with SMI face when participating in a web-based (WebMOVE) or in-person (MOVE-SMI) version of the same SMI-adapted MOVE weight-management program']",[],['engagement and emotional and motivational factors'],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]",[],"[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",277.0,0.0667573,"Results of post hoc analyses found the association between engagement and emotional and motivational factors to be statistically significant.
","[{'ForeName': 'Tanya T', 'Initials': 'TT', 'LastName': 'Olmos-Ochoa', 'Affiliation': 'Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center.'}, {'ForeName': 'Noosha', 'Initials': 'N', 'LastName': 'Niv', 'Affiliation': 'Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center, and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Cohen', 'Affiliation': 'Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center, and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Oberman', 'Affiliation': 'VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Goldberg', 'Affiliation': 'VA Capitol Healthcare Network Mental Illness, Research, Education, and Clinical Center.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Young', 'Affiliation': 'VA Greater Los Angeles Healthcare System, and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000363']
3529,31097441,"Comparison of changes in corneal endothelial cell density and central corneal thickness between conventional and femtosecond laser-assisted cataract surgery: a randomised, controlled clinical trial.","BACKGROUND/AIM


To identify changes in endothelial cell density (ECD) and central corneal thickness (CCT) in eyes undergoing femtosecond laser-assisted cataract surgery (FLACS) compared with conventional phacoemulsification surgery (CPS).
METHODS


This is an intraindividual randomised, controlled clinical trial. One eye was randomised to receive FLACS, while the contralateral eye of the same patient received CPS. The femtosecond laser pretreatment included creating main and side-port corneal incisions, capsulotomy and lens fragmentation. Non-contact endothelial cell microscopy and pachymetry were performed preoperatively and at postoperative day 1, week 1, month 1 and month 3.
RESULTS


A total of 134 paired eyes from 67 patients were included in the analysis. ECD was not significantly different between the two groups at either postoperative month 1 (2370±580 cells/mm 2  and 2467±564 cells/mm 2  in FLACS and CPS groups, respectively; p=0.18) or at postoperative month 3 (2374±527 cells/mm 2  and 2433±526 cells/mm 2  in FLACS and CPS groups, respectively; p=0.19). No significant difference was observed in the mean CCT values between the two groups over the follow-up period (p>0.05).
CONCLUSION


Postoperative corneal ECD and CCT were comparable between FLACS and CPS during the 3 months' follow-up period.",2020,"No significant difference was observed in the mean CCT values between the two groups over the follow-up period (p>0.05).
","['A total of 134 paired eyes from 67 patients were included in the analysis', 'eyes undergoing']","['CPS', 'femtosecond laser-assisted cataract surgery (FLACS', 'conventional and femtosecond laser-assisted cataract surgery', 'conventional phacoemulsification surgery (CPS', 'FLACS and CPS', 'femtosecond laser pretreatment included creating main and side-port corneal incisions, capsulotomy and lens fragmentation', 'FLACS']","['mean CCT values', 'corneal endothelial cell density and central corneal thickness', 'endothelial cell density (ECD) and central corneal thickness (CCT', 'ECD']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}]",67.0,0.0917905,"No significant difference was observed in the mean CCT values between the two groups over the follow-up period (p>0.05).
","[{'ForeName': 'Daliya', 'Initials': 'D', 'LastName': 'Dzhaber', 'Affiliation': 'Cornea, Cataract and External Diseases, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Mustafa', 'Affiliation': 'Wilmer Eye institute, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Alsaleh', 'Affiliation': 'Ophthalmology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mihailovic', 'Affiliation': 'Glaucoma, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Yassine J', 'Initials': 'YJ', 'LastName': 'Daoud', 'Affiliation': 'Wilmer Eye institute, Johns Hopkins University, Baltimore, Maryland, USA ydaoud1@jhmi.edu.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313723']
3530,31144258,"Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.","BACKGROUND


The objective of this study was to determine the clinical usefulness of videolaryngoscopes (VLs) by comparing the time to intubation (TTI) and the ease of intubation of McGrath MAC VL (MVL), Pentax Airway Scope VL (PVL), and Macintosh direct laryngoscope (DL) during nasotracheal intubation using manual in-line stabilization to simulate difficult airways.
METHODS


One hundred and twenty patients were randomly assigned to the MVL group (n = 40), the PVL group (n = 40), and the DL group (n = 40). Nasotracheal intubation was performed using MVL, PVL, or DL, according to group assignments. The primary outcome was TTI and secondary outcomes were glottic view, ease of intubation, and bleeding.
RESULTS


The TTI was significantly shorter in the MVL group than in the DL group (45 sec vs 57 sec; difference in means: - 12; 95% confidence interval [CI], - 21 to - 3; P = 0.01). The percentage of glottic opening and Cormack Lehane grade were significantly superior in the MVL and the PVL groups compared with the DL group (both P < 0.001). The intubation difficulty scale and numeric rating scale regarding ease of intubation were also significantly lower in the MVL and PVL groups than in the DL group (all P < 0.007). The incidence of bleeding was significantly lower in the MVL group than in the DL group (3 vs 15, relative risk 0.2; 95% CI, 0.06 to 0.64; P = 0.001).
CONCLUSION


This study showed that both MVL and PVL provided better visualization of the glottis and easier intubation, with less additional manipulation than DL during nasotracheal intubation in simulated difficult airways. Additionally, use of the MVL significantly shortened the TTI compared with the DL.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02647606); registered 6 January, 2016.",2019,The intubation difficulty scale and numeric rating scale regarding ease of intubation were also significantly lower in the MVL and PVL groups than in the DL group (all P < 0.007).,"['One hundred and twenty patients', 'patients with manual in-line stabilization']","['MVL and PVL', 'McGrath MAC VL (MVL), Pentax Airway Scope VL (PVL), and Macintosh direct laryngoscope (DL', 'PVL', 'McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope', 'Nasotracheal intubation', 'videolaryngoscopes (VLs', 'MVL']","['TTI and secondary outcomes were glottic view, ease of intubation, and bleeding', 'intubation difficulty scale and numeric rating scale regarding ease of intubation', 'percentage of glottic opening and Cormack Lehane grade', 'incidence of bleeding']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}]","[{'cui': 'C0761034', 'cui_str': 'tsetse thrombin inhibitor'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0222045'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",120.0,0.103555,The intubation difficulty scale and numeric rating scale regarding ease of intubation were also significantly lower in the MVL and PVL groups than in the DL group (all P < 0.007).,"[{'ForeName': 'Go Un', 'Initials': 'GU', 'LastName': 'Roh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Bundang CHA General Hospital, Seongnam, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Kyung Cheon', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Bundang CHA General Hospital, Seongnam, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea. kjyeop@ajou.ac.kr.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01409-5']
3531,31147964,"Single-use, patient-specific instrumentation technology in knee arthroplasty: a comparative study between standard instrumentation and PSI efficiency system.","Patient-specific instrumentation is a surgical technique that was created to improve the accuracy of implantation, surgical time and workflow in total knee arthroplasty. This study is a single-center, single-surgeon randomized clinical trial. The aim of this work was to evaluate clinical efficacy of PSI versus standard surgical instrumentation in malalignment risk and blood loss reduction. From April 2015 to September 2016, 40 patients for a total of 40 knees were included in the randomization process. Each patient underwent CT scan of the lower limb including hip, knee and ankle joint with the realization of the PSI system and the TKA with Medacta GMK Primary ® . Patients were evaluated 1 month after surgery with X-ray and after 2 months with clinical examination and assessment by Knee Society Score (KSS). Blood loss was detected by adding the values calculated in the operative room and the blood loss in the vacuum systems. In the study group, mean value of KSS was 85.2 (IC 95% 81.2-88.5), mean blood loss was 657 ml (IC 95% 580.6-735.4), and mean value of femorotibial angle was 178.8° (IC 95% 178.5-179.3). In the control group, mean value of KSS was 87.2 (IC 95% 85.3-89.4), mean blood loss was 866.5 ml (IC 95% 763.3-972.5), and mean value of femorotibial angle was 178.9°(IC 95% 177.6-180.3). The Student t test detected a significant difference in blood loss between groups (p < 0.05), and no differences were found between KSS. The single-use instrumentation should improve precision, operative time, turnover time, sterilization and maintenance costs and could help to reduce infection risks. Our results confirm only the improvement on reducing blood loss. In our opinion, this technique should be used in selected patients when the surgeon could have some difficulties to perform femoral cuts on coronal plane or when patients need to have a very little blood loss due to other conditions.",2020,"The Student t test detected a significant difference in blood loss between groups (p < 0.05), and no differences were found between KSS.","['knee arthroplasty', 'From April 2015 to September 2016, 40 patients for a total of 40 knees were included in the randomization process']",['PSI versus standard surgical instrumentation'],"['blood loss', 'malalignment risk and blood loss reduction', 'precision, operative time, turnover time, sterilization and maintenance costs', 'Knee Society Score (KSS', 'mean value of femorotibial angle', 'Blood loss', 'mean blood loss', 'mean value of KSS']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",40.0,0.0602689,"The Student t test detected a significant difference in blood loss between groups (p < 0.05), and no differences were found between KSS.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Giannotti', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, University of Siena, Banchi di Sotto 55, 53100, Siena, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sacchetti', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, University of Pisa, Via Paradisa, 2, 56124, Pisa, Italy. federico.sacchetti1989@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Citarelli', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, University of Pisa, Via Paradisa, 2, 56124, Pisa, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bottai', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, University of Pisa, Via Paradisa, 2, 56124, Pisa, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bianchi', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, University of Pisa, Via Paradisa, 2, 56124, Pisa, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Agostini', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, University of Pisa, Via Paradisa, 2, 56124, Pisa, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Capanna', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, University of Pisa, Via Paradisa, 2, 56124, Pisa, Italy.'}]",Musculoskeletal surgery,['10.1007/s12306-019-00612-3']
3532,31682941,Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol.,"BACKGROUND


Diabetes prevention remains a top public health priority; digital approaches are potential solutions to existing scalability and accessibility challenges. There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings.
PURPOSE


To describe the methods and design of a type 1 hybrid effectiveness-implementation trial of a digital diabetes prevention program (DPP) using the iPARIHS and RE-AIM frameworks.
METHODS


The trial will contrast the effects of two DPP interventions: (1) small group, in-person class, and (2) a digital DPP consisting of small group support, personalized health coaching, digital tracking tools, and weekly behavior change curriculum. Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the CDC National DPP. Adults at risk for diabetes (BMI ≥25 and 5.7% ≤ HbA1c ≤ 6.4) will be randomly assigned to either the intervention group (n = 241) or the small group (n = 241). Assessment of primary (HbA1c) and secondary (weight loss, costs, cardiovascular risk factors) outcomes will occur at baseline, 4, and 12 months. Additionally, the trial will explore the potential for future adoption, implementation, and sustainability of the digitally-based intervention within a regional healthcare system based on key informant interviews and assessments of organizational administrators and primary care physicians.
CONCLUSION


This trial of a digital DPP will allow the research team to determine the relationships between reach, effectiveness, implementation, and costs.",2020,"There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings.
",['Adults at risk for diabetes (BMI ≥25 and 5.7%\u202f≤\u202fHbA1c\u202f≤\u202f6.4'],"['digital DPP', 'digital diabetes prevention program (DPP', 'DPP interventions: (1) small group, in-person class, and (2) a digital DPP consisting of small group support, personalized health coaching, digital tracking tools, and weekly behavior change curriculum']","['Assessment of primary (HbA1c) and secondary (weight loss, costs, cardiovascular risk factors) outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0392735,"There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings.
","[{'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Almeida', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States; Center for Reducing Health Disparities, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: Fabio.almeida@unmc.edu.'}, {'ForeName': 'Tzeyu L', 'Initials': 'TL', 'LastName': 'Michaud', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States; Center for Reducing Health Disparities, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: tzeyu.michaud@unmc.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Wilson', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: kathryn.wilson@unmc.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Schwab', 'Affiliation': 'Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: rjschwab@unmc.edu.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: cody.goessl@unmc.edu.'}, {'ForeName': 'Gwenndolyn C', 'Initials': 'GC', 'LastName': 'Porter', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: gwenndolyn.porter@unmc.edu.'}, {'ForeName': 'Fabiana A', 'Initials': 'FA', 'LastName': 'Brito', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: fabiana.silva@unmc.edu.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Evans', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27157, United States. Electronic address: gevans@wakehealth.edu.'}, {'ForeName': 'Emily V', 'Initials': 'EV', 'LastName': 'Dressler', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27157, United States. Electronic address: Emily.Dressler@wakehealth.edu.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Boggs', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, United States. Electronic address: boggae17@wfu.edu.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Katula', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, United States. Electronic address: katulaj@wfu.edu.'}, {'ForeName': 'Cynthia Castro', 'Initials': 'CC', 'LastName': 'Sweet', 'Affiliation': 'Medical Affairs, Omada Health, Inc., San Francisco, CA 94111, United States. Electronic address: cynthia@omadahealth.com.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States; Center for Reducing Health Disparities, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: paul.estabrooks@unmc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105877']
3533,31563804,Positive urgency worsens the impact of normative feedback on 21st birthday drinking.,"BACKGROUND


The 21st birthday is associated with more alcohol consumption and negative consequences than any other occasion. The current study investigated how positive urgency, the tendency to act rashly in response to positive emotions, influences 21st birthday drinking and the effectiveness of a single event text message intervention designed to reduce 21st birthday drinking and related negative consequences.
METHODS


Participants were 183 undergraduate students (69% female, 86% white) about to turn 21. Participants were randomly assigned to either a text message intervention or control condition. Those in the intervention condition received one text message the day before their 21st birthday that provided personalized normative feedback and one text message on the day of their 21st birthday. Participants reported actual alcohol consumption the day after their 21st birthday celebration.
RESULTS


Hierarchical linear regression found that, after controlling for sex, intervention condition, and planned drinking, positive urgency was associated with greater number of drinks (β = .15, p = .031) and drinking problems (β = .25, p = .001). A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]): At high levels of positive urgency, the intervention condition was associated with drinking more than planned, which significantly mediated the relationship between intervention and alcohol-related consequences; the mediation was not significant at mean or low levels of positive urgency.
CONCLUSIONS


These findings are the first to link positive urgency with 21st birthday drinking and to empirically demonstrate that positive urgency negatively impacts the effectiveness of an intervention aimed at reducing alcohol consumption.",2019,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","['Participants were 183 undergraduate students (69% female, 86% white) about to turn 21']",['text message intervention or control condition'],"['actual alcohol consumption', 'drinking problems']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0198354,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","[{'ForeName': 'Zachary T', 'Initials': 'ZT', 'LastName': 'Whitt', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States. Electronic address: zacwhitt@iu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States.'}, {'ForeName': 'Nichea', 'Initials': 'N', 'LastName': 'Spillane', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States; Department of Psychology, University of Rhode Island, Kingston, RI, United States; Rhode Island Training School, Department of Children, Youth and Families, Cranston, RI, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Schick', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Cyders', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107559']
3534,31100155,MUST Beg to Differ.,"The authors provide a significant interpretation of the National Eye Institute-sponsored Multicenter Uveitis Steroid Treatment study, in which patients with severe, non-infectious intermediate, posterior, or panuveitis were randomly assigned to receive local treatment using the sutured intravitreal fluocinolone acetonide implant or systemic treatment consisting of oral steroids and conventional steroid-sparing immunosuppression, with a primary outcome of visual acuity at 2 years of follow-up. The authors also present evidence-based guidance for the treatment of noninfectious posterior segment involving uveitis. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:266-268.].",2019,The authors also present evidence-based guidance for the treatment of noninfectious posterior segment involving uveitis.,"['patients with severe, non-infectious intermediate, posterior, or panuveitis']",['fluocinolone acetonide implant or systemic treatment consisting of oral steroids and conventional steroid-sparing immunosuppression'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}]","[{'cui': 'C0016298', 'cui_str': 'Fluocinolone Acetonide'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]",[],,0.0636471,The authors also present evidence-based guidance for the treatment of noninfectious posterior segment involving uveitis.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Albini', 'Affiliation': ''}, {'ForeName': 'Natalia F', 'Initials': 'NF', 'LastName': 'Callaway', 'Affiliation': ''}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Feuer', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Careen', 'Initials': 'C', 'LastName': 'Lowder', 'Affiliation': ''}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': ''}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Galor', 'Affiliation': ''}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Goldhardt', 'Affiliation': ''}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Flynn', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20190503-01']
3535,31810405,"Short-term Effects of Thoracic Spine Thrust Manipulation, Exercise, and Education in Individuals With Low Back Pain: A Randomized Controlled Trial.","OBJECTIVE


To determine the short-term effectiveness of thoracic manipulation when compared to sham manipulation for individuals with low back pain (LBP).
DESIGN


Randomized controlled trial.
METHODS


Patients with LBP were stratified based on symptom duration and randomly assigned to a thoracic manipulation or sham manipulation treatment group. Groups received 3 visits that included manipulation or sham manipulation, core stabilization exercises, and patient education. Factorial repeated-measures analysis of variance and multiple regression were performed for pain, disability, and fear avoidance. The Mann-Whitney  U  test was used to analyze patient-perceived improvement, via the global rating of change scale, at follow-up.
RESULTS


Ninety participants completed the study (mean ± SD age, 38 ± 11.5 years; 70% female; 72% with chronic LBP). The overall group-by-time interaction was not significant for the Modified Oswestry Disability Questionnaire, numeric pain-rating scale, and Fear-Avoidance Beliefs Questionnaire outcomes. The global rating of change scale was not significantly different between groups.
CONCLUSION


Three sessions of thoracic manipulation, education, and exercise did not result in improved outcomes when compared to a sham manipulation, education, and exercise in individuals with chronic LBP. Future studies are needed to identify the most effective management strategies for the treatment of LBP.
LEVEL OF EVIDENCE


Therapy, level 1b.  J Orthop Sports Phys Ther 2020;50(1):24-32. Epub 6 Dec 2019. doi:10.2519/jospt.2020.8928 .",2020,"Three sessions of thoracic manipulation, education, and exercise did not result in improved outcomes when compared to a sham manipulation, education, and exercise in individuals with chronic LBP.","['Individuals With Low Back Pain', 'Patients with LBP', 'Ninety participants completed the study (mean ± SD age, 38 ± 11.5 years; 70% female; 72% with chronic LBP', 'individuals with chronic LBP', 'individuals with low back pain (LBP']","['3 visits that included manipulation or sham manipulation, core stabilization exercises, and patient education', 'thoracic manipulation', 'thoracic manipulation or sham manipulation treatment group', 'Thoracic Spine Thrust Manipulation, Exercise, and Education', 'J Orthop Sports']","['Modified Oswestry Disability Questionnaire, numeric pain-rating scale, and Fear-Avoidance Beliefs Questionnaire outcomes', 'pain, disability, and fear avoidance', 'global rating of change scale']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure (body structure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",90.0,0.164608,"Three sessions of thoracic manipulation, education, and exercise did not result in improved outcomes when compared to a sham manipulation, education, and exercise in individuals with chronic LBP.","[{'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Alvar', 'Affiliation': ''}, {'ForeName': 'Sara F', 'Initials': 'SF', 'LastName': 'Maher', 'Affiliation': ''}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.8928']
3536,31325040,Daily intake of wheat germ-enriched bread may promote a healthy gut bacterial microbiota: a randomised controlled trial.,"PURPOSE


Wheat bran fibre has a beneficial effect on gastrointestinal function, but evidence for wheat germ is scarce. Accordingly, we evaluated the effects of daily intake of wheat germ on gastrointestinal discomfort and gut microbiota by adding wheat germ to refined (white) wheat bread, the most consumed bread type. We hypothesised that an improvement in the composition of refined bread could beneficially affect intestinal health without compromising consumers' acceptance.
METHODS


Fifty-five healthy adults were recruited for a randomised, double-blind, crossover, controlled trial comprising two 4-week intervention periods separated by a 5-week washout stage. During the first 4-week period, one group consumed wheat bread enriched with 6 g of wheat germ and the control group consumed non-enriched wheat bread.
RESULTS


Wheat germ-enriched bread was well-appreciated and the number of participants that demonstrated minimal gastrointestinal improvements after wheat-germ intake was higher than in the control arm. Importantly, intake of wheat germ-enriched bread decreased the perceived gastrointestinal discomfort-related quality of life (subscale worries and concerns) over refined white bread. The improvements in the gastrointestinal function were accompanied by favourable changes in gut microbiota, increasing the number of Bacteroides spp. and Bifidobacterium spp.
CONCLUSIONS


Adding wheat germ to industrially made white bread without altering sensory properties may promote a healthy gut bacterial microbiota and the gastrointestinal health.",2020,"RESULTS


Wheat germ-enriched bread was well-appreciated and the number of participants that demonstrated minimal gastrointestinal improvements after wheat-germ intake was higher than in the control arm.","['healthy gut bacterial microbiota', 'Fifty-five healthy adults']","['wheat bread enriched with 6\xa0g of wheat germ and the control group consumed non-enriched wheat bread', 'Daily intake of wheat germ-enriched bread']","['gastrointestinal discomfort and gut microbiota', 'gastrointestinal discomfort-related quality of life (subscale worries and concerns', 'number of Bacteroides spp', 'gastrointestinal function', 'minimal gastrointestinal improvements']","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]",55.0,0.0922088,"RESULTS


Wheat germ-enriched bread was well-appreciated and the number of participants that demonstrated minimal gastrointestinal improvements after wheat-germ intake was higher than in the control arm.","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Moreira-Rosário', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal. andrerosario@med.up.pt.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Marques', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Helder', 'Initials': 'H', 'LastName': 'Pinheiro', 'Affiliation': 'Nutrition and Metabolism, NOVA Medical School, NOVA University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Norberto', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Sintra', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'José António', 'Initials': 'JA', 'LastName': 'Teixeira', 'Affiliation': 'Center of Biological Engineering, University of Minho, Campus of Gualtar, Braga, Portugal.'}, {'ForeName': 'Conceição', 'Initials': 'C', 'LastName': 'Calhau', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Luís Filipe', 'Initials': 'LF', 'LastName': 'Azevedo', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}]",European journal of nutrition,['10.1007/s00394-019-02045-x']
3537,31245859,Are There Gender-based Effects for an Educational Program for Parents of Adolescents With Risk Behaviors?,"The goals of this study were to evaluate the gender-based effectiveness of the parental intervention of the Suspertu (""recovery"" in English) prevention program for adolescents with risk behaviors in Spain. The sample included 229 parents (105 fathers and 124 mothers). One open-label trial with repeated measures was used. Parents received a family therapy and a group education. The intervention improved parents' authoritative parenting style, decreasing the degree of parental stress and reducing parent's psychopathological symptoms and maladjustment. Improvement in both groups (fathers and mothers) was mainly observed from pre- to post-intervention assessment. According to the results, prevention programs for adolescents with risk behaviors may be a suitable context both to teach parents to deal appropriately with their children's risk behaviors, and to improve parent's psychological state.",2020,"The intervention improved parents' authoritative parenting style, decreasing the degree of parental stress and reducing parent's psychopathological symptoms and maladjustment.","['adolescents with risk behaviors', '229 parents (105 fathers and 124 mothers', 'adolescents with risk behaviors in Spain']","['Suspertu (""recovery"" in English) prevention program']","[""parents' authoritative parenting style"", ""degree of parental stress and reducing parent's psychopathological symptoms and maladjustment""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",229.0,0.0228773,"The intervention improved parents' authoritative parenting style, decreasing the degree of parental stress and reducing parent's psychopathological symptoms and maladjustment.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fernández-Montalvo', 'Affiliation': 'Universidad Pública de Navarra.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Arteaga', 'Affiliation': 'Universidad Pública de Navarra.'}, {'ForeName': 'José J', 'Initials': 'JJ', 'LastName': 'López-Goñi', 'Affiliation': 'Universidad Pública de Navarra.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ituráin', 'Affiliation': 'Fundación Proyecto Hombre Navarra.'}]",Journal of marital and family therapy,['10.1111/jmft.12396']
3538,31314925,"Pharmacokinetic and Pharmacodynamic Effects of a γ-Secretase Modulator, PF-06648671, on CSF Amyloid-β Peptides in Randomized Phase I Studies.","γ-Secretase modulators (GSMs) represent a promising therapy for Alzheimer's disease by reducing pathogenic amyloid-β (Aβ) peptide production. Three phase I studies (NCT02316756, NCT02407353, and NCT02440100) investigated the safety/tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of the oral GSM, PF-06648671. A PK/PD indirect-response model was developed (using biomarker data) to simultaneously characterize differential effects of PF-06648671 on multiple Aβ species in cerebrospinal fluid (CSF). Healthy subjects (n = 120) received single doses or multiple-ascending doses of PF-06648671/placebo for 14 days. No serious adverse events occurred; severe adverse eventswere deemed not drug related. PF-06648671 decreased Aβ42 and Aβ40 concentrations in CSF, with greater effects on Aβ42, and increased Aβ37 and Aβ38 levels, particularly Aβ37. No significant change in total Aβ was observed. The PK/PD model well described the tendency of observed CSF Aβ data and the steady-state effects of PF-06648671, supporting its use for predicting central Aβ effects and optimal dose selection for GSMs in future trials.",2020,"PF-06648671 decreased Aβ42 and Aβ40 concentrations in CSF, with greater effects on Aβ42, and increased Aβ37 and Aβ38 levels, particularly Aβ37.",['Healthy subjects (n=120) received'],"['γ-Secretase modulators (GSMs', 'single- or multiple-ascending doses of PF-06648671/placebo']","['safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the oral GSM, PF-06648671', 'total Aβ', 'Aβ42, and increased Aβ37 and Aβ38 levels, particularly Aβ37']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0171484', 'cui_str': 'APP Secretase'}, {'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0344376,"PF-06648671 decreased Aβ42 and Aβ40 concentrations in CSF, with greater effects on Aβ42, and increased Aβ37 and Aβ38 levels, particularly Aβ37.","[{'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Ahn', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Carrieri', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dela Cruz', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Fullerton', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hajos-Korcsok', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Constantino', 'Initials': 'C', 'LastName': 'Kantaridis', 'Affiliation': 'Brussels CRU, Pfizer Inc, Brussels, Belgium.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Leurent', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Richann', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Mendes da Costa', 'Affiliation': 'Brussels CRU, Pfizer Inc, Brussels, Belgium.'}, {'ForeName': 'Ruolun', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1570']
3539,31900673,Ceramic laminate veneers: effect of preparation design and ceramic thickness on fracture resistance and marginal quality in vitro.,"OBJECTIVES


The aim of the present study was to investigate the influence of five different preparation designs and two different ceramic thicknesses on margin quality and fracture resistance of ceramic laminate veneers after thermomechanical loading in vitro.
MATERIALS AND METHODS


Eighty human central incisors were randomly assigned to 10 groups (n = 8) with five different preparation designs: non-prep (NP), minimally invasive (MI) = exclusively enamel-bonded, semi-invasive (SI) = 50% bonded in dentin, invasive (I) = 100% in dentin, and semi-invasive with two additional class III composite resin restorations (SI-C). IPS InLine veneers were fabricated in two thicknesses (L1 = 0.2-0.5 mm; L2 = 0.5-1.2 mm). After adhesive luting (OptiBond FL, Variolink Veneer) with light curing and polishing, specimens were stored in distilled water at 37 °C for 21 days, then thermocycled (2000 cycles between + 5 and + 55 °C), and finally mechanically loaded at the incisal edge at an angle of 45° for 2,000,000 cycles at 50 N und further 1,000,000 cycles at 100 N. Impressions were taken initially, after thermocycling, and after every 250,000 mechanical cycles in order to evaluate cracks and margin quality under a SEM. The veneers were evaluated in a light microscope (× 20) for cracks, chippings, partial, and catastrophic fractures.
RESULTS


Margin quality after three million cycles revealed medians for continuous margin of 82-95% without significant differences among groups, neither at the ceramic/composite (p = 0.943) nor at the tooth/composite interface (p = 0.571). Visual inspection of veneers exhibited 22 cracks, 11 chippings, 4 partial and 4 catastrophic fractures in 38 of 80 veneers. The statistical ranking regarding fracture risk (p ≤ 0.05) was: IL1 = SIL1 = MIL1 = IL2 = CL1 = CL2, MIL2 = NPL1 = NPL2 = SIL2, IL2 = CL1 = CL2 = MIL2 = NPL1 = NPL2 = SIL2.
CONCLUSIONS


Even after three million cycles with up to 100 N, all groups showed high survival rates. However, the fracture risk increases with thin veneers and preparations with medium to high dentin portions when compared to thicker veneers with preparations in enamel or partially in dentin (p ≤ 0.05). Preexisting resin composite restorations did not show any significant influence on margin quality and facture risk (p > 0.05).
CLINICAL RELEVANCE


Ceramic laminate veneers are extremely durable with thin veneers and substantial enamel loss being main risk factors for fracture.",2020,"RESULTS


Margin quality after three million cycles revealed medians for continuous margin of 82-95% without significant differences among groups, neither at the ceramic/composite (p = 0.943) nor at the tooth/composite interface (p = 0.571).",['Eighty human central incisors'],"['five different preparation designs: non-prep (NP), minimally invasive (MI) = exclusively enamel-bonded, semi-invasive (SI) = 50% bonded in dentin, invasive (I) = 100% in dentin, and semi-invasive with two additional class III composite resin restorations (SI-C']","['Margin quality', 'margin quality and facture risk', 'survival rates', 'margin quality and fracture resistance', 'fracture resistance and marginal quality', 'fracture risk']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",80.0,0.0304453,"RESULTS


Margin quality after three million cycles revealed medians for continuous margin of 82-95% without significant differences among groups, neither at the ceramic/composite (p = 0.943) nor at the tooth/composite interface (p = 0.571).","[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Blunck', 'Affiliation': 'Department of Operative and Preventive Dentistry, CharitéCentrum for Dentistry, Charité-Universitätsmedizin Berlin, Assmannshauser Str. 4-6, 14197, Berlin, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'Department of Operative and Preventive Dentistry, CharitéCentrum for Dentistry, Charité-Universitätsmedizin Berlin, Assmannshauser Str. 4-6, 14197, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hajtó', 'Affiliation': ', Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Frei', 'Affiliation': ', Munich, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Frankenberger', 'Affiliation': 'Department of Operative Dentistry, Endodontics, and Pediatric Dentistry, Medical Center for Dentistry, University Medical Center Giessen and Marburg, Campus Marburg, Georg-Voigt-Str. 3, 35039, Marburg, Germany. frankbg@med.uni-marburg.de.'}]",Clinical oral investigations,['10.1007/s00784-019-03136-z']
3540,31314954,The effect of intradermal microdosing of a transient receptor potential cation channel subfamily V member 1 antagonist on heat evoked pain and thermal thresholds in normal and ultraviolet-C exposed skin in healthy volunteers.,"BACKGROUND


Three TRPV1 (Transient Receptor Potential Vanilloid Receptor 1) antagonists were developed for testing in situ in human skin (Sjögren et al., 2016; Sjögren et al., 2018; Sjögren et al., 2018). The first human study using these compounds and capsaicin, was performed to determine the required local antagonist concentrations needed for target engagement (Proof of Mechanism, PoM) (Sjögren et al., 2018). In this paper, the aim was to address a TRPV1 antagonist's ability to inhibit a more complex pain signal and to define translational endpoints that could be used in further drug development, when progressing orally bioavailable TRPV1 antagonists as novel analgesic medications.
METHOD


This was a single centre, placebo-controlled, clinical proof of principle (PoP) study in 25 healthy volunteers. The subjects were exposed to UV irradiation, causing a local tissue inflammation. Three different doses of AZ12048189 were administered to assess pain perception through quantitative sensory testing (QST) and erythema using Laser Doppler scanning.
RESULTS


AZ12048189 increased the warmth detection threshold (WDT) and the heat pain threshold (HPT) and decreased the intensity of supra threshold heat pain (STHP). AZ12048189 did not, however, have any significant effects as assessed using mechanical stimulation or Laser Doppler.
CONCLUSIONS


This study validated translational tools to confirm target engagement for TRPV1 antagonists; WDT, HPT and STHP have utility in this respect, after oral administration of a TRPV1 antagonist. This study also proved that TRPV1 antagonists can inhibit a more complex, non-capsaicin dependent thermally induced pain signal.",2019,"RESULTS


AZ12048189 increased the warmth detection threshold (WDT) and the heat pain threshold (HPT) and decreased the intensity of supra threshold heat pain (STHP).","['25 healthy volunteers', 'healthy volunteers']","['capsaicin', 'transient receptor potential cation channel subfamily V member 1 antagonist', 'TRPV1']","['intensity of supra threshold heat pain (STHP', 'mechanical stimulation or Laser Doppler', 'warmth detection threshold (WDT) and the heat pain threshold (HPT', 'pain perception through quantitative sensory testing (QST) and erythema']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C1563722', 'cui_str': 'Transient Receptor Potential Channels'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1285354', 'cui_str': 'Mechanical stimulation'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",25.0,0.0277686,"RESULTS


AZ12048189 increased the warmth detection threshold (WDT) and the heat pain threshold (HPT) and decreased the intensity of supra threshold heat pain (STHP).","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Sjögren', 'Affiliation': 'Department of Pharmacy, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ståhle', 'Affiliation': 'CLINTEC, Karolinska University Hospital Huddinge, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Quiding', 'Affiliation': '3diva, Växjö, Sweden.'}, {'ForeName': 'Bror', 'Initials': 'B', 'LastName': 'Jonzon', 'Affiliation': 'Medical Products Agency, Uppsala, Sweden.'}, {'ForeName': 'Magnus M', 'Initials': 'MM', 'LastName': 'Halldin', 'Affiliation': 'AlzeCure Foundation, Karolinska Institute Science Park, Huddinge, Sweden.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Sundgren', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}]","European journal of pain (London, England)",['10.1002/ejp.1451']
3541,31135888,The effect of ticagrelor on growth of small abdominal aortic aneurysms-a randomized controlled trial.,"AIMS


To evaluate if ticagrelor, an effective platelet inhibitor without known non-responders, could inhibit growth of small abdominal aortic aneurysms (AAAs).
METHODS AND RESULTS


In this multi-centre randomized controlled trial, double-blinded for ticagrelor and placebo, acetylic salicylic acid naïve patients with AAA and with a maximum aortic diameter 35-49 mm were included. The primary outcome was mean reduction in log-transformed AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months compared with baseline. Secondary outcomes include AAA-diameter growth rate and intraluminal thrombus (ILT) volume enlargement rate. A total of 144 patients from eight Swedish centres were randomized (72 in each group). MRI AAA volume increase was 9.1% for the ticagrelor group and 7.5% for the placebo group (P = 0.205) based on intention-to-treat analysis, and 8.5% vs. 7.4% in a per-protocol analysis (P = 0.372). MRI diameter change was 2.5 mm vs. 1.8 mm (P = 0.113), US diameter change 2.3 mm vs. 2.2 mm (P = 0.778), and ILT volume change 12.9% vs. 10.4% (P = 0.590).
CONCLUSION


In this RCT, platelet inhibition with ticagrelor did not reduce growth of small AAAs. Whether the ILT has an important pathophysiological role for AAA growth cannot be determined based on this study due to the observed lack of thrombus modulating effect of ticagrelor.
TRIAL REGISTRATION


The TicAAA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT02070653.",2020,"MRI diameter change was 2.5 mm vs 1.8 mm (p = 0.113), US diameter change 2.3 mm vs 2.2 mm (p = 0.778), and ILT volume change 12.9% vs 10.4% (p = 0.590).
","['naïve patients with AAA and with a maximum aortic diameter 35-49\u2009mm were included', '144 patients from eight Swedish centers']","['ticagrelor and placebo, acetylic salicylic acid', 'ILT', 'ticagrelor']","['MRI diameter change', 'ILT volume change', 'AAA-diameter growth rate and ILT volume enlargement rate', 'MRI AAA volume increase', 'mean reduction in log-transformed AAA volume growth rate (%) measured with magnetic resonance imaging (MRI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0579133', 'cui_str': 'Aortic diameter (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036080', 'cui_str': 'Salicylic Acids'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]",,0.709248,"MRI diameter change was 2.5 mm vs 1.8 mm (p = 0.113), US diameter change 2.3 mm vs 2.2 mm (p = 0.778), and ILT volume change 12.9% vs 10.4% (p = 0.590).
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wanhainen', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mani', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kullberg', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala SE-75185, Sweden.'}, {'ForeName': 'Sverker', 'Initials': 'S', 'LastName': 'Svensjö', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bersztel', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Karlsson', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Holst', 'Affiliation': 'Department of Vascular Diseases, Malmö University Hospital, Malmö SE-21421, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gottsäter', 'Affiliation': 'Department of Vascular Diseases, Malmö University Hospital, Malmö SE-21421, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Linné', 'Affiliation': 'Department of Surgery, Vascular Surgery and Department of Clinical Science and Education, Karolinska Institutet at Södersjukhuset, Stockholm SE-11883, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gillgren', 'Affiliation': 'Department of Surgery, Vascular Surgery and Department of Clinical Science and Education, Karolinska Institutet at Södersjukhuset, Stockholm SE-11883, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Langenskiöld', 'Affiliation': 'Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg SE-41345, Sweden.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Hultgren', 'Affiliation': 'Department of Vascular Surgery, Karolinska University Hospital, Stockholm SE-17164, Sweden.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Roy', 'Affiliation': 'Department of Vascular Surgery, Karolinska University Hospital, Stockholm SE-17164, Sweden.'}, {'ForeName': 'Nils-Peter', 'Initials': 'NP', 'LastName': 'Gilgen', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ahlström', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala SE-75185, Sweden.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Lederle', 'Affiliation': 'Department of Medicine (III-0), Veterans Affairs Medical Center, One Veterans Drive, Minneapolis, Minnesota 55417, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Björck', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}]",Cardiovascular research,['10.1093/cvr/cvz133']
3542,31958772,Kinetic and Kinematic Changes in Vertical Jump in Prepubescent Girls After 10 Weeks of Plyometric Training.,"PURPOSE


To examine the effect of a 10-week plyometric training (PT) on the kinematic and kinetic properties of prepubescent girls during squat jump, countermovement jump, and drop jumps.
METHODS


Twenty-four untrained girls (aged 9-11 y) were assigned to a training group (TG) and a control group. The TG followed twice a week PT for 10 weeks. Squat jump, countermovement jump, and drop jumps performed from heights of 20, 35, and 50 cm were tested before and after PT. Jump height, kinematic, and kinetic parameters were evaluated using a motion analysis system and a force plate.
RESULTS


Jumping height in all jump types increased significantly after PT for the TG (P < .001). After training, the TG presented increased power (P < .001) and knee angular velocity (P < .001), higher knee flexion at the deepest point during the braking phase (P < .001), longer contact time (P < .001), and unchanged stiffness and reaction strength index (P > .05). No differences were observed in the control group (P > .05).
CONCLUSION


These findings indicate that a 10-week PT positively affected jumping performance in prepubescent girls who improved their drop jump performance after training not by adopting a stiff/bouncing jumping style of short contact time and increased stiffness, but a compliant/absorbing style of prolonged contact time.",2020,"After training, the TG presented increased power (P < .001) and knee angular velocity (P < .001), higher knee flexion at the deepest point during the braking phase (P < .001), longer contact time (P < .001), and unchanged stiffness and reaction strength index (P > .05).","['Prepubescent Girls', 'Twenty-four untrained girls (aged 9-11\xa0y']","['training group (TG', 'Plyometric Training', '10-week plyometric training (PT']","['longer contact time', 'Kinetic and Kinematic Changes in Vertical Jump', 'higher knee flexion', 'unchanged stiffness and reaction strength index', 'knee angular velocity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",24.0,0.0185251,"After training, the TG presented increased power (P < .001) and knee angular velocity (P < .001), higher knee flexion at the deepest point during the braking phase (P < .001), longer contact time (P < .001), and unchanged stiffness and reaction strength index (P > .05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Katsikari', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Bassa', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Skoufas', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Savvas', 'Initials': 'S', 'LastName': 'Lazaridis', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Kotzamanidis', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Patikas', 'Affiliation': 'Aristotle University of Thessaloniki.'}]",Pediatric exercise science,['10.1123/pes.2019-0188']
3543,31984473,Comparison of Urethral Dilation with Amplatz Dilators and Internal Urethrotomy Techniques for the Treatment of Urethral Strictures.,"PURPOSE


The most common option for the management of urethral stricture (US) is direct visual internal urethrotomy (DVIU), because it is an easy and minimally invasive technique but the low success and high recurrence rates of this technique make urologists research for different types of therapeutic alternatives in stricture treatment. In this study we aimed to compare the internal urethrotomy with amplatz dilation for the treatment of male US.
MATERIALS AND METHODS


A total of sixty patients, who have been operated due to urethral stricture were enrolled into this study. Group 1 was treated with amplatz renal dilators and the group 2 was treated with cold knife urethrotomy. All patients were evaluated for Qmax preoperatively and at the first, 3rd, 9th and 12th months postoperatively.
RESULTS


In the 3 month uroflowmetry results, mean Q max values were 15.6±2 ml/sec in amplatz group and 15.5±1.6 ml/sec in DVIU group. There was no statisticaly difference between the two groups. However the Q max values in the postoperative 9 and 12 months were significantly decreased in the DVIU group. In the DVIU group 9 recurrences (36%) appeared and 2 of these reccurrences were in the first 3 months, whereas in the amplatz group no recurrences appeared in the first 3 months. The urethral stricture recurrence rate up to the 12 month follow up was statistically significant for group 1 when it is compared with group 2. Conclusions: In our experience, amplatz dilation is a good option as the initial treatment for urethral stricture.",2020,The urethral stricture recurrence rate up to the 12 month follow up was statistically significant for group 1 when it is compared with group 2. ,"['male US', 'sixty patients, who have been operated due to urethral stricture', 'Urethral Strictures']","['Urethral Dilation with Amplatz Dilators and Internal Urethrotomy Techniques', 'amplatz renal dilators', 'internal urethrotomy with amplatz dilation', 'cold knife urethrotomy']","['urethral stricture recurrence rate', 'mean Q max values', 'Q max values']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}]","[{'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0181467', 'cui_str': 'Knife, device (physical object)'}, {'cui': 'C0194550', 'cui_str': 'Incision of urethra (procedure)'}]","[{'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.015268,The urethral stricture recurrence rate up to the 12 month follow up was statistically significant for group 1 when it is compared with group 2. ,"[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Karsli', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey. onurkarsli@yahoo.com.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ustuner', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey.'}, {'ForeName': 'Omur', 'Initials': 'O', 'LastName': 'Memik', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Ulukaradag', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4662']
3544,31953834,"Effect of Different Musical Types on Patient's Relaxation, Anxiety and Pain Perception during Shock Wave Lithotripsy: A Randomized Controlled Study.","PURPOSE


The aim of this study was to investigate the effects of listening to different music types during extracorporeal shock wave lithotripsy (SWL) on the patients' pain control, anxiety level, and satisfaction.
MATERIALS AND METHODS


This study was a prospective single-blinded, paral-lel-group randomized clinical trial with balanced ran-domization [1:1]. A total of 150 patients who underwent first-session SWL were included in the study. The patients were randomly divided in to five groups (30 participants in each group) as follows: headphones were not put on and no music was played in Group 1 (control group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was listened to with headphones in Group 4; thetype of music the patient liked was listened to with headphones in Group 5. Demographic data related to patients and procedure, State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure (0: never 4: happily), and patient satisfaction rates (0: poor 4: excellent) were recorded immediately after the procedure.
RESULTS


There was a statistically significant difference between groups in terms of median VAS scores (7, 6, 4.5, 5, and 4, respectively, P<.001), whereas the VAS scores in Groups 3, 4, and 5 were significantly lower than those in Group 1 and 2 (P<.001). The median STAI-SA scores between the groups were significantly different (45, 45, 42, 45, and 40, respectively, P<.001), while the anxiety levels in Groups 3, 4, and 5 were significantly lower than those in Group 1 (P=.008, P=.018, and P<.001, respectively). Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
CONCLUSIONS


Music therapy during SWL reduced the patients' pain and anxiety scores, moreover listening to the patient's preferred music type provided greater satisfaction. Listening to the patient's preferred music type could be standardized and routinely used during SWL.",2020,"Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
","['150 patients who underwent first-session SWL were included in the study', 'Shock Wave Lithotripsy']","['extracorporeal shock wave lithotripsy (SWL', 'headphones were not put on and no music was played in Group 1 (control group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was listened to with headphones in Group 4; thetype of music the patient liked was listened to with headphones in Group 5', 'Different Musical Types', 'Music therapy']","['median VAS scores', ""patients' pain and anxiety scores"", 'pain control, anxiety level, and satisfaction', 'anxiety levels', 'willingness to repeat the procedure and patient satisfaction rates', 'VAS scores', ""Patient's Relaxation, Anxiety and Pain Perception"", 'State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure ', 'median STAI-SA scores', 'patient satisfaction rates']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",30.0,0.0563542,"Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Çift', 'Affiliation': 'Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey. dr.alicift@gmail.com.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Benlioglu', 'Affiliation': 'Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.5333']
3545,31780277,"Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial.","BACKGROUND


Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients.
METHODS


In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete.
FINDINGS


Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up.
INTERPRETATION


Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.
FUNDING


American College of Gastroenterology.",2020,"INTERPRETATION


Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients.","['high-risk patients', '1037 eligible patients', 'enrolled patients from six tertiary medical centres in the USA', 'Eligible patients were those at high risk for the development of pancreatitis after ERCP', 'Between July 9, 2013, and March 22, 2018']","['rectal indometacin', 'placebo suppository', 'Rectal indometacin dose escalation', 'endoscopic retrograde cholangiopancreatography', 'endoscopic retrograde cholangiopancreatography (ERCP', 'placebo', 'indometacin', 'indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories', 'additional 50 mg indometacin suppository', 'standard-dose (n=515) or high-dose indometacin']","['acute kidney injury', 'frequency and severity of pancreatitis', 'transient ischaemic attack', 'development of pancreatitis after ERCP', 'Clinically significant bleeding', 'Pancreatitis after ERCP', 'allergic reactions or deaths', 'ST elevation myocardial infarction']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]",1037.0,0.367675,"INTERPRETATION


Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients.","[{'ForeName': 'Evan L', 'Initials': 'EL', 'LastName': 'Fogel', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA. Electronic address: efogel@iu.edu.'}, {'ForeName': 'Glen A', 'Initials': 'GA', 'LastName': 'Lehman', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tarnasky', 'Affiliation': 'University of Texas Southwestern, Digestive Health Associates of Texas, Dallas, TX, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Cote', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Suzette E', 'Initials': 'SE', 'LastName': 'Schmidt', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Akbar K', 'Initials': 'AK', 'LastName': 'Waljee', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Peter D R', 'Initials': 'PDR', 'LastName': 'Higgins', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Watkins', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Richard S Y', 'Initials': 'RSY', 'LastName': 'Kwon', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Grace H', 'Initials': 'GH', 'LastName': 'Elta', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Easler', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Pleskow', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Scheiman', 'Affiliation': 'Division of Gastroenterology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Ihab I', 'Initials': 'II', 'LastName': 'El Hajj', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA; Division of Gastroenterology, University of Balamand, Beirut, Lebanon.'}, {'ForeName': 'Nalini M', 'Initials': 'NM', 'LastName': 'Guda', 'Affiliation': ""Division of Gastroenterology, University of Wisconsin, Milwaukee, WI, USA; Aurora St Luke's Medical Center, Milwaukee, WI, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Gromski', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'McHenry', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Seena', 'Initials': 'S', 'LastName': 'Arol', 'Affiliation': 'University of Texas Southwestern, Digestive Health Associates of Texas, Dallas, TX, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Korsnes', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alejandro L', 'Initials': 'AL', 'LastName': 'Suarez', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA; Division of Gastroenterology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Division of Gastroenterology, University of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hofbauer', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30337-1']
3546,31923472,Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial.,"Despite the burdens costs can place on adults with diabetes, few evidence-based, scalable interventions have been identified that address prevalent health-related financial burdens and unmet social risk factors that serve as major obstacles to effective diabetes management. In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care. We will determine the effectiveness of CareAvenue relative to standard care with respect to improving glycemic control and patient-centered outcomes such as cost-related non-adherence (CRN) behaviors and perceived financial burden. We will also examine the role of patient risk factors (moderators) and behavioral factors (mediators) on the effectiveness of CareAvenue in improving outcomes. We will recruit 720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden. Participants will be randomized to one of two arms: 1) receipt of a 15-20 min web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services. Outcomes will be assessed at baseline and 6- and 12-month follow-up. Clinical Trial Registration: ClinicalTrials.gov ID NCT03950973, May 2019.",2020,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","['720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden', 'adults with diabetes']",['receipt of a 15-20\u202fmin web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services'],['unmet social risk factors and diabetes outcomes'],"[{'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",720.0,0.0729143,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America. Electronic address: minalrp@umich.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; Department of Internal Medicine, Michigan Medicine, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Hae Mi', 'Initials': 'HM', 'LastName': 'Choe', 'Affiliation': 'College of Pharmacy, University of Michigan, United States of America; University of Michigan Medical Group, United States of America.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tobi', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105933']
3547,30703663,Self-initiated gradual smoking reduction among community correction smokers.,"INTRODUCTION


Smoking remains the leading cause of preventable death in the United States. Many smoking cessation guidelines advise smokers to quit precipitately; however, most quit attempts involve a more gradual cessation. Characteristics of individuals who tend to reduce prior to quitting and the effectiveness of pre-quit reduction are not well understood. This study examined individual differences and smoking cessation outcomes between individuals who self-initiated gradual reduction in cigarettes per day (CPD) and those who did not reduce prior to quit date.
METHODS


This study is a secondary analysis from a randomized clinical trial of smoking cessation with pharmacotherapy among individuals under community corrections supervision. We compared participants who self-initiated smoking reduction by at least 25% between baseline and the first treatment session (n = 128) to participants who either increased or did not reduce smoking between baseline and the first treatment session (n = 354).
RESULTS


African American race, no previous cigar smoking, no previous use of pharmacotherapy for smoking cessation, less withdrawal symptoms at baseline, and older age at first smoking were associated with being a self-initiated gradual reduction in univariate analyses. Individuals who self-initiated gradual reduction also had a had a greater likelihood of achieving at least one quit during the one-year study period as compared to those who did not reduce prior to the intervention.
CONCLUSIONS


Individuals who self-initiate gradual reduction differ from those who increase or do not change their smoking prior to a quit date. Gradual reduction also increased success in quitting.",2019,"Individuals who self-initiated gradual reduction also had a had a greater likelihood of achieving at least one quit during the one-year study period as compared to those who did not reduce prior to the intervention.
","['community correction smokers', 'individuals under community corrections supervision', 'participants who self-initiated smoking reduction by at least 25% between baseline and the first treatment session (n\u202f=\u202f128) to participants who either increased or did not reduce smoking between baseline and the first treatment session (n\u202f=\u202f354', 'individuals who self-initiated gradual reduction in cigarettes per day (CPD) and those who did not reduce prior to quit date']",['pharmacotherapy'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.0126064,"Individuals who self-initiated gradual reduction also had a had a greater likelihood of achieving at least one quit during the one-year study period as compared to those who did not reduce prior to the intervention.
","[{'ForeName': 'Mickeah J', 'Initials': 'MJ', 'LastName': 'Hugley', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, Volker Hall L107, 1670 University Blvd., Birmingham, AL 35233, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Wolford-Clevenger', 'Affiliation': 'Department of Psychology, University of Tennessee-Knoxville, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Sisson', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, Volker Hall L107, 1670 University Blvd., Birmingham, AL 35233, USA.'}, {'ForeName': 'Angela T', 'Initials': 'AT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, Volker Hall L107, 1670 University Blvd., Birmingham, AL 35233, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Cropsey', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, Volker Hall L107, 1670 University Blvd., Birmingham, AL 35233, USA. Electronic address: kcropsey@uabmc.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.01.028']
3548,31740425,A Phase II randomized controlled trial for lung and diaphragm protective ventilation (Real-time Effort Driven VENTilator management).,"Lung Protective Mechanical Ventilation (MV) of critically ill adults and children is lifesaving but it may decrease diaphragm contraction and promote Ventilator Induced Diaphragm Dysfunction (VIDD). An ideal MV strategy would balance lung and diaphragm protection. Building off a Phase I pilot study, we are conducting a Phase II controlled clinical trial that seeks to understand the evolution of VIDD in critically ill children and test whether a novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can balance lung and diaphragm protective ventilation to reduce time on MV. REDvent systematically adjusts PEEP, FiO 2 , inspiratory pressure, tidal volume and rate, and uses real-time measures from esophageal manometry to target normal levels of patient effort of breathing. This trial targets 276 children with pulmonary parenchymal disease. Patients are randomized to REDvent vs. usual care for the acute phase of MV (intubation to first Spontaneous Breathing Trial (SBT)). Patients in either group who fail their first SBT will be randomized to REDvent vs usual care for weaning phase management (interval from first SBT to passing SBT). The primary clinical outcome is length of weaning, with several mechanistic outcomes. Upon completion, this study will provide important information on the pathogenesis and timing of VIDD during MV in children and whether this computerized protocol targeting lung and diaphragm protection can lead to improvement in intermediate clinical outcomes. This will form the basis for a larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day ventilator free days. Clinical Trials Registration: NCT03266016.",2020,Patients in either group who fail their first SBT will be randomized to REDvent vs usual care for weaning phase management (interval from first SBT to passing SBT).,"['300 children with pulmonary parenchymal disease', 'critically ill adults and children', 'critically ill children']","['diaphragm protective ventilation', 'Lung Protective mechanical ventilation (MV']","['PEEP, FiO2, inspiratory pressure, tidal volume and rate, and uses real-time measures from esophageal manometry to target normal levels of patient effort of breathing', 'length of weaning, with several mechanistic outcomes']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449770', 'cui_str': 'Measured from (attribute)'}, {'cui': 'C0199873', 'cui_str': 'Esophageal manometry (procedure)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]",300.0,0.106836,Patients in either group who fail their first SBT will be randomized to REDvent vs usual care for weaning phase management (interval from first SBT to passing SBT).,"[{'ForeName': 'Robinder G', 'Initials': 'RG', 'LastName': 'Khemani', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America. Electronic address: rkhemani@chla.usc.edu.""}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Hotz', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America.""}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Klein', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America.""}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Kwok', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America.""}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'University of Southern California, Keck School of Medicine, Department of Preventative Medicine, United States of America.'}, {'ForeName': 'Christianne', 'Initials': 'C', 'LastName': 'Lane', 'Affiliation': 'University of Southern California, Keck School of Medicine, Department of Preventative Medicine, United States of America.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kohler', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America.""}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Suresh', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America.""}, {'ForeName': 'Dinnel', 'Initials': 'D', 'LastName': 'Bornstein', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America.""}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Elkunovich', 'Affiliation': ""University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America; Children's Hospital of Los Angeles, Department of Emergency Medicine, United States of America.""}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Ross', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Deakers', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Beltramo', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.""}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Nelson', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.""}, {'ForeName': 'Anoopindar', 'Initials': 'A', 'LastName': 'Bhalla', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.""}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': ""Children's Hospital Philadelphia, University of Pennsylvania, United States of America.""}, {'ForeName': 'Christopher J L', 'Initials': 'CJL', 'LastName': 'Newth', 'Affiliation': ""Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105893']